Measurement of NonInvasive Blood Pressure With DINAMAP SuperSTAT and Datex-Ohmeda With Intra-arterial Blood Pressure in Neonates Through Adults and Special Populations
Conditions: Blood Pressure
Sponsor: GE Healthcare

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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NCT02125331 
Measurement of NonInvasive Blood Pressure with DINAMAP SuperSTAT 
and Datex-Ohmeda with Intra-arterial Blood Pressure in Neonates through 
Adults and Special Populations (MISSION Trial) 
 
03Mar2017 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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Study Title: 
Measurement of NonInvasive Blood Pressure 
with DINAMAP SuperSTAT and Datex-
Ohmeda with Intra-arterial Blood Pressure in 
Neonates through Adults and Special 
Populations (MISSION Trial) 
Study Number: 
123.04-2013-GES-0008 
Revision/Amendment: Revision 7.0 
Version Date: 
03/Mar/2017 
 
Confidentiality Statement 
This protocol is provided for conducting a research study. The information contained in this document is 
confidential and, except to the extent necessary to obtain informed consent or EC/IRB approval, cannot be 
disclosed unless required by governmental regulation. Persons to whom any portion of the contents of this 
document is disclosed must be informed that the information is confidential and may not further be disclosed by 
them. 
 
 
 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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Measurement of NonInvasive Blood Pressure with DINAMAP SuperSTAT and 
Datex-Ohmeda with Intra-arterial Blood Pressure in Neonates through Adults 
and Special Populations (MISSION Trial) 
GEHC Study Number: 123.04-2013-GES-0008 
Revision/Amendment: 7.0 
Version Date: 03/Mar/2017 
Investigator’s Signature Page 
I hereby agree to: 
(i)   Conduct the investigation in accordance with the agreement, the investigational plan, FDA or 
applicable government regulations, and conditions of approval imposed by the reviewing Ethics 
Committee, IRB or governing regulatory body; 
(ii)  Supervise all testing of the device involving human subjects; and 
(iii) Ensure that the requirements for obtaining informed consent are met. 
 
 
 
Investigator Signature 
 
Date 
 
 
Print Name 
 
 
Site Name 
 
Site Address 
 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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Table of Contents 
This document contains the following sections: 
Topic 
Page 
Investigator’s Signature Page .................................................................... 3 
Table of Contents ...................................................................................... 5 
Document and Version Control ................................................................. 8 
Abbreviations ............................................................................................ 9 
1. Study Synopsis ................................................................................... 10 
2. Preliminary Investigations and Justification ....................................... 12 
2.1. 
Literature Review .......................................................................................... 12 
2.2. 
Pre-Clinical (animal) Trials and Previous Clinical (human) Experience ........... 13 
2.3. 
Device Risk Analysis ....................................................................................... 14 
3. Research Device and/or Product ........................................................ 15 
3.1. 
Identification and Description of Research Device/Product .......................... 15 
3.2. 
Regulatory Status .......................................................................................... 21 
3.3. 
Risk Category/Rationale (US Only) ................................................................. 21 
3.4. 
Device/Product Classification and Rationale ................................................. 22 
3.5. 
Device/Product Issuance and Replacement ................................................... 23 
3.6. 
Disposition of the device/product ................................................................. 23 
4. Objectives of Research Study ............................................................. 23 
4.1. 
Hypothesis ..................................................................................................... 23 
4.2. 
Study Objectives ............................................................................................ 24 
4.3. 
Study Endpoints ............................................................................................. 24 
5. Design of Research Study ................................................................... 24 
5.1. 
Type of Research Study ................................................................................. 24 
5.2. 
Controls and Minimization of Bias ................................................................. 26 
6. Study Subjects .................................................................................... 26 
6.1. 
Subject Population ......................................................................................... 26 
6.2. 
Protection of Vulnerable Subjects ................................................................. 26 
6.3. 
Number of Subjects ....................................................................................... 26 
6.4. 
Inclusion Criteria ............................................................................................ 28 
6.5. 
Exclusion Criteria ........................................................................................... 28 
6.6. 
Screening Subjects for Enrollment ................................................................. 29 
7. Procedures for Research Study ........................................................... 29 
7.1. 
Setup Procedures .......................................................................................... 29 
7.2. 
Study Procedures ........................................................................................... 30 
7.3. 
Data Storage .................................................................................................. 33 
7.4. 
Withdrawal and Discontinuation Criteria ...................................................... 33 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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8. Training Plan ...................................................................................... 33 
8.1. 
Training Plan for Research Device/Product ................................................... 33 
8.2. 
Training Plan for Protocol .............................................................................. 34 
9. Data Analysis and Statistics ................................................................ 34 
9.1. 
Statistical Analysis Methods .......................................................................... 34 
9.2. 
Determining Reference Invasive Blood Pressure Per ISO 81060-2:2013........ 34 
9.3. 
Analysis of Subject Characteristics ................................................................. 35 
9.4. 
Interim Analysis ............................................................................................. 36 
9.5. 
Handling of Missing Data ............................................................................... 37 
9.6. 
Pass/Fail Criteria of the Study ........................................................................ 37 
10. Deviations .......................................................................................... 37 
10.1. Management of Protocol Deviations ............................................................. 37 
11. Complaint Handling and Adverse Event Reporting ............................. 37 
11.1. Foreseeable Adverse Events and Device Effects ............................................ 37 
11.2. Adverse Event Definitions .............................................................................. 39 
11.3. Management of Adverse Event Reporting ..................................................... 39 
11.4. Management of Serious Adverse Event and Unanticipated Adverse Device 
Effect Reporting ............................................................................................. 40 
11.5. Management of Device Complaints ............................................................... 40 
12. Early Termination or Suspension ........................................................ 41 
12.1. Criteria for Early Termination or Suspension ................................................. 41 
12.2. Withdrawal of EC/IRB Approval ..................................................................... 41 
13. Ethics Committee (EC) and Regulatory Filings ..................................... 41 
13.1. Regulatory Authority Approval Requirements (Global) ................................. 41 
13.2. Ethics Committee Approval Requirements .................................................... 41 
13.3. Management of Protocol Revisions/Amendments ........................................ 41 
13.4. Informed Consent and Privacy Requirements ............................................... 42 
14. Data and Quality Management .......................................................... 42 
14.1. Management of Data ..................................................................................... 42 
14.2. Subject De-identification ............................................................................... 43 
14.3. Completion of Case Report Forms (CRFs) ...................................................... 43 
14.4. Record Retention at the Site .......................................................................... 43 
15. Monitoring Plan ................................................................................. 44 
15.1. Brief Description ............................................................................................ 44 
15.2. Reference to Approved Monitoring Plan ....................................................... 44 
16. Publication Policy ............................................................................... 44 
17. Additional Study Materials / Additional Country-Specific Regulatory 
Requirements ..................................................................................... 44 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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References .............................................................................................. 45 
Appendix A: Amendment to Protocol Version 1.0 ................................... 47 
Appendix B: Amendment to Protocol Version 2.0 ................................... 48 
Appendix C: Amendment to Protocol Version 3.0 .................................... 63 
Appendix D: Amendment to Protocol Version 4.0 ................................... 80 
Appendix E: Amendment to Protocol Version 5.0 .................................... 83 
Appendix F: Amendment to Protocol Version 6.0 .................................... 90 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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Document and Version Control 
This section records all changes made to the protocol for a specific study. In the table below, record 
each and every relevant change by indicating what changes were made. 
Revision 
Date 
(DD/Mmm/YYYY) 
Revision Author 
Comments/Changes 
1.0 
31/Oct/2013 
Angela Johnson 
Initial draft. 
2.0 
03/Dec/2014 
Stephanie Karwedsky Table 3: Updated Neonate III Weight to “≥ 2000g” 
Section 6.4: Updated Inclusion Criteria 1 and 2 
Section 7.11: Removed Date of Birth, added Age 
Section 7.1.3: Removed reference to evaluation to be 
performed by two observers and a supervisor as this is a 
requirement of ISO 81060-2:2013 (E) Chapter 5 and 
therefore is not applicable to this study 
Section 7.1.3: Removed numbering of 7.1.4 as formatting 
was incorrect 
Section 7.1.3: Blood Pressure Assessments- Corrected 
verbiage to match ISO 81060-2:2013 (E) for #2  
3.0 
26/May/2015 
Stephanie Karwedsky, 
Angela Johnson 
Revised as per Appendices A (Amendment 1) and Appendix 
B (Amendment 2) to include detail of changes in version 
2.0 and 3.0. 
4.0 
18/Jan/2016 
Angela Johnson 
Revised as per Appendix C (Amendment 3) to include detail 
of changes in version 3.0 to 4.0. 
5.0 
30/Jun/2016 
Angela Johnson 
Revised as per Appendix D (Amendment 4) to include 
detail of changes in version 4.0 to 5.0. 
6.0 
16/Feb/2017 
Angela Johnson 
Revised as per Appendix E (Amendment 5) to include detail 
of changes in version 5.0 to 6.0. 
7.0 
03/Mar/2017 
Angela Johnson 
Revised as per Appendix F (Amendment 6) to include detail 
of changes in version 6.0 to 7.0. 
 
 
 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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ABBREVIATIONS 
AAMI   
Association for Advancement of Medical Instrumentation  
BP 
 
BP 
DCS 
 
Data collection system 
ECG 
 
Electrocardiogram 
GEHC  
GE Healthcare 
GxP 
 
Good Processing Tools (validated research tools, not for commercial use) 
LCS 
 
Life Care Solutions  
IABP 
 
Intra-arterial blood pressure 
IBP 
 
Invasive blood pressure 
ISO 
 
International Standards Organization 
MAA 
 
Maximum amplitude algorithm 
MAP 
 
Mean blood pressure 
NIBP 
 
Noninvasive blood pressure 
PAD 
 
Peripheral Artery Disease 
PDM 
 
Patient Data Module (for CARESCAPE B650) 
PSM 
 
Patient Side Module (for CARESCAPE B650) 
Psys 
 
Systolic pressure 
Pt  
 
Target pressure 
 
 
 
 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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1. STUDY SYNOPSIS 
Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in 
Neonates through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Research Type: 
Clinical (human)  
 
Pre-Clinical (animal) 
 
External Bench 
 
 
Brief Description of Study Purpose: This study is required to demonstrate that the non-invasive blood 
pressure (NIBP) measurement algorithms on two commercially available multifunction hemodynamic 
acquisition modules, the Patient Data Module (PDM) equipped with the DINAMAP® SUPERSTAT algorithm 
(“PDM-SUPERSTAT”) and the Patient Side Module (PSM) equipped with Datex-Ohmeda GE algorithm 
(“PSM-Datex-Ohmeda”), provide accurate NIBP measurements in accordance with the guidelines provided 
by the  most recent International Organization for Standardization (ISO) 81060-2:2013. 
Notably, the new ISO 81060-2:2013 supersedes the previous 2009 version of this standard, and this study is 
being conducted in accordance with the most recent applicable standards. 
This study will assess neonate, infant, children, pediatric, adolescent, and adult patients as well as adults 
with chronic atrial fibrillation in a population that requires non-emergent heart catheterization.  
Sponsor Name:  GE Healthcare 
Sponsor Contact:  
Stephanie Karwedsky,  
Clinical Affairs Project Manager III 
 
Address:  
 
3000 N Grandview Blvd 
 
Waukesha, WI 53188-1696 US 
Telephone:   
+1-262-443 7008 
E-mail:          Stephanie.Karwedsky@ge.com  
Investigator Names: 
 
David Scott Marks, MD MBA, Professor and Vice 
Chair of Medicine and Radiology, Director of Cardiac 
Catheterization Laboratories and Clinical Trials,  
Froedtert Hospital/Medical College of Wisconsin 
Address:  
    9200 West Wisconsin Avenue  
         Milwaukee, WI 53226 
Telephone:   
414-805-0579  
E-mail: 
    dmarks@mcw.edu  
 
Jeffrey Garland, MD 
Director of Perinatal Research 
Wheaton Franciscan Healthcare – St. Joseph’s 
 
 
Russel Hirsch, MD  
Associate Professor of Pediatrics 
Director, Cardiac Catheterization Laboratory 
Director, Pulmonary Hypertension Service 
Cincinnati Children's Hospital Medical Center 
(CCHMC) 
Address:       
5000 West Chambers Street 
                        
Milwaukee, WI 53210 
Telephone:   
414- 447-2663 
E-mail: 
    jsgarland@hotmail.com 
 
Address:       
3333 Burnet Avenue 
                       Cincinnati, OH 45229  
Telephone:   
515-636-7072 
E-mail: 
    Russel.hirsch@cchmc.org  
Device/Product GEHC Modality: Life Care Solutions (LCS) 
Device/Product Class: Monitoring Solutions 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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Device/Product Description: 
Non-invasive blood pressure (NIBP) measurement algorithms of two multifunction hemodynamic 
acquisition modules compatible with the CARESCAPE Monitor B650 patient monitor are under study in this 
trial, as follows: 
• 
PSM-Datex-Ohmeda: Patient Side Module (PSM) with Datex-Ohmeda GE NIBP algorithm.  
• 
PDM-SuperSTAT: Patient Data Module (PDM) with DINAMAP® SuperSTAT NIBP algorithm. 
The control used in this study is gold standard aortic invasive blood pressure (IBP). Data may be collected on 
the DASH® 4000 patient monitor equipped with the non-commercial GEHC DC-EDIT and GEHC DC-
COLLECTOR GxP software that can be compared with data either manually collected from the NIBP 
CARESCAPE Monitor B650 monitor, or data may be collected using the GxP-validated GEHC PDM Data 
Collection Module, which is capable of collecting electronic data typically displayed using patient monitors. 
The GxP-validated systems used in this study serve the sole function of enabling the device to directly 
output data such as blood pressure waveforms and parameters to the computerized data collection system 
(DCS) for storage and analysis purposes. 
Regulatory Status: 
Pre-Market 
 The commercial DASH® 4000 patient monitor (control system) equipped with GxP 
validated non-commercial DC-COLLECTOR and DC-Edit software programs for data 
collection is considered investigational. The acquisition modules PDM-SuperSTAT and 
PSM-Datex-Ohmeda with the PSM-Datex-Ohmeda and PDM-SuperSTAT algorithms 
and used on the CARESCAPE Monitor B650 and accessories are commercially 
available, The PDM is  considered investigational when GxP-validated PDM Data 
Collection Module is used, which functions in the same manner as the PDM but with 
additional ability to collect research data typically displayed on a patient monitor. 
Though pre- and post- market devices are utilized, all aspects of the study will be 
considered investigational. 
Post-Market 
  
 
Research Manager Name: Petra Peltola 
Address:  
 
Kuortaneenkatu 2 
    Helsinki, 00510 FI 
Telephone:  
+358 40 354 8482 
E-mail:           
Petra.Peltola@ge.com  
Medical Monitor Name: Helena Haukilehto, MD  
 
Address:        
Kuortaneenkatu 2 
    Helsinki, 00510 FI 
Telephone:  
+358-103943609 
E-mail:           
Helena.Haukilehto@ge.com 
 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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2. 
PRELIMINARY INVESTIGATIONS AND JUSTIFICATION 
2.1. Literature Review 
Introduction 
Accurate blood pressure measurement is essential to providing optimal care in hospitals and 
other clinical settings, and non-invasive blood pressure (NIBP) has overwhelmingly become the 
contemporary clinical standard for blood pressure measurement. 1 Accurate blood pressure (BP) 
measurement is dependent on a trained observer using validated, calibrated, and properly 
maintained equipment, which has led to increasing emphasis on adherence of commercial NIBP 
devices to validated standards for accuracy and reliability. 2 While previous studies have shown 
that arterial waveforms can be accurately and reproducibly reconstructed using oscillometric 
algorithms, such as the DINAMAP® SUPERSTAT and Datex-Ohmeda GE algorithms studied in this 
trial, the accuracy of these NIBP measurement algorithms has also been shown to have high 
variability in patients with variant age and cardiac disease status. 3 Thus, there is a need to 
evaluate these algorithms against a validated clinical standard applicable to commercial 
sphygmomanometers.  
ISO 81060-2:2013 
Because the widely-accepted International Organization for Standardization (ISO) 81060-2:2009 
standard has recently been updated to the ISO 81060-2:2013 version, it is necessary to reassess 
algorithms that have been previously tested under the predicate standard under the newest 
available standard in order to be compliant with United States regulatory standards. Notably, 
the new ISO 81060-2:2013 supersedes the previous 2009 version of this standard, and this study 
is being conducted in accordance with the most recent applicable ISO standard. ISO 81060-
2:2013 standard provides a well-accepted set of requirements for the clinical assessment of 
sphygmomanometers used for intermittent, non-invasive, automatic estimation of arterial blood 
pressure using blood pressure cuffs against gold standard IBP measurement. This standard 
provides an objective basis for the assessment of all sphygmomanometers that sense or display 
pulsations, flow, or sounds in order to generate estimations, displays, or recordings of blood 
pressure in human patients. Notably, these standards are applied broadly across devices that 
use very different blood pressure assessment algorithms. The basis of this standard is 
comparison of the studied NIBP assessment devices to widely-accepted gold standard invasive 
blood pressure (IBP) measurement, less commonly referred to as intra-arterial blood pressure 
(IABP). 
Noninvasive Blood Pressure (NIBP) vs. Gold Standard Intra-Arterial Invasive Blood Pressure 
(IBP) measurements 
Direct blood pressure readings taken from major arteries, such as the aorta, are considered the 
gold standard in blood pressure assessment. In adults, IBP is a very common procedure used in 
Intensive Care Units that involves advancing a catheter into a major artery for continuous blood 
pressure monitoring. 4 Umbilical artery catheters are also among the most commonly used 
blood pressure monitoring methodologies in neonatal intensive care units, in part because of 
their high accuracy. 5 Because of the notable risks associated with arterial catheterization, 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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alternative NIBP measurements have also become routinely used in modern clinical practice. 1  
Numerous studies, have, however reported discrepancies between the blood pressure 
measurement provided by NIBP devices measurements and IBP measurements, particularly in 
special patient populations such as those with cardiac disease. 3, 1 Thus, contemporary NIBP 
algorithms should be validated against highly accurate gold standard IBP measurements to 
ensure accuracy and reliability of these devices. 
Oscillometric NIBP Measurement 
The basic physiological principles that underlie NIBP technologies were first documented in the 
mid-1970s, and significant improvements have since been made in the algorithms that drive 
NIBP assessment. 6  In the past decade, there has been increasing theoretical discourse regarding 
the optimal methods for evaluation of arterial mechanical properties and blood pressure pulse 
using noninvasive oscillometric maximum amplitude algorithm (MAA) estimates of the mean 
blood pressure obtained with air-filled occlusive cuffs. 7 These data, once collected, can be 
mathematically extrapolated from experimental IBP measurements and waveform simulations 
and then recorded as exponential models. Most recently, automatic NIBP measurement systems 
have come to market that use highly specialized software algorithms to account for cuff 
pressure oscillations caused by the peripheral flow of blood either as discrete intervals or areas 
under a curve, allowing greater accuracy to be achieved using NIBP monitoring methods. 8  As a 
result, modern NIBP algorithms are generally more accurate than their predecessors. 7 
Noninvasive indirect oscillometric determination of blood pressure has significant advantages 
over invasive blood pressure assessments, as cuff inflation and deflation results in minimal 
discomfort and complications. 9 Oscillometric NIBP assessment algorithms are able to 
noninvasively estimate systolic, mean, and diastolic pressure. 10 In fact, this technique has 
become so popular that one survey reported more than 400 commercial device employing 
monitors that use NIBP algorithms available from numerous suppliers worldwide, though the 
accuracy of these models vary widely and may be poor in certain patient subpopulations. 11 
Both the Datex-Ohmeda GE algorithm and the DINAMAP® SuperSTAT algorithms investigated in 
this study are oscillometric algorithms for assessment of NIBP from data collected using an 
occlusive air-filled cuff. 
2.2. Pre-Clinical (animal) Trials and Previous Clinical (human) Experience 
Previous study has indicated that the GE DINAMAP® SuperSTAT algorithm on the GE CARESCAPE 
Patient Monitor Series or DASH® Monitor Series is accurate in adult, children, and neonate 
patients, including hypotensive and hypertensive patients. 12 Furthermore, the GE DINAMAP® 
SuperSTAT algorithm and the Datex Ohmeda GE algorithm have also been reported to satisfy 
the ANSI/AAMI SP10-2002 and SP10A-1996 American National Standard for Electronic or 
Automated Sphygmomanometers in adults and, for GE DINAMAP® SuperSTAT only, neonatal 
populations, meaning that all values were ±5 mmHg with a standard deviation of ≤ 8 mmHg of 
reference standards.  
The Datex-Ohmeda GE algorithm has been successfully used to monitor blood pressure in adult 
patients and to predict vascular change and fluid loading, demonstrating results similar to 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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reference standard intra-arterial monitors in 26 patients according to the Association for 
Advancement of Medical Instrumentation (AAMI) standards. 13 Compared to other oscillometric 
blood pressure measurement algorithms, Datex Ohmeda GE was shown to be somewhat slower 
but equally accurate in a study involving 160 blood pressure recordings. 14 
2.3. Device Risk Analysis 
Participation in this study has no direct benefit to participants; however, participants may 
benefit from more reliable assessment of blood pressure readings during their procedure due to 
the use of multiple devices and multiple recordings for blood pressure measurement. The NIBP 
device does not pose additional risks to patients, but there are risks associated with the 
additional IBP comparator procedures above the required clinical care for participating subjects. 
Use of existing indwelling lines in very young patients is designed to minimize additional 
disruption of care in pediatric patients. 
The NIBP measurement (PDM-SuperSTAT and PSM-Datex-Ohmeda) devices and all patient 
monitors used in this study under study are commercially available, and all devices will be used 
according to their labeling. The GxP-validated GEHC PDM Data Collection Module may, when 
possible, be used to enable digital export of research data typically displayed on patient 
monitors.. The GxP-validated GEHC PDM Data Collection module works in the same way as the 
commercially available PDM module, but also has software to enable digital export of the data 
for research use. The validated non-commercial DC-EDIT and DC-COLLECTOR equipment for the 
DASH® 4000 and GEHC PDM Data Collection Module serve as a data output connections only 
and are not expected to impact the clinical function of the device. Participation in this study is 
not expected to impact patient management, clinical diagnosis, or treatment strategy compared 
to that which would be determined by the standard of care outside of this study. 
2.3.1. Risk Analysis for Subjects with Indwelling Lines (≤29 days of age) 
Eligible subjects aged 29 days or less will be recruited only if they currently have, or are 
scheduled to have, an indwelling femoral, radial, or umbilical arterial monitoring line placed. The 
type of line places will be determined according to the site standard of care, and not altered 
based on participation in the study. While radial lines are the most commonly placed indwelling 
lines in neonates, femoral and umbilical lines share a similar safety profile and, in some cases, 
are preferred in order to preserve integrity of vessels when future interventions may be 
required. 15 Like radial and femoral line placements, umbilical lines have been shown to have a 
minimal complication rate even during longer procedures when performed by experienced 
physicians. 5, 15 For these subjects, NIBP measurements will be taken in a minimally disruptive 
manner in order to minimize possible interruption in their care. No additional lines will be 
placed for study purposes. These patients may participate for up to three days, taking as few 
determinations as necessary to accomplish research objectives each day under the supervision 
of a medically qualified investigator. There is not expected to be a significant risk to subjects 
based on placement of measurement devices in this study. 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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2.3.2. Risk Analysis for Subjects undergoing Non-Emergent Aortic Catheterization (aged >29 
days to adult) 
Patients aged 29 days or older having prescribed non-emergent aortic catheterization 
procedures will be enrolled. Typical catheterization procedures in pediatric patients involve the 
use of general anesthesia for the duration of the clinically indicated procedure. The risks 
associated with general anesthesia are well documented and are widely considered safe when 
prudently administered. 16, 17, 18 Due to study participation, the duration of general anesthesia 
may be slightly increased by a period of about 25 minutes (1-2 minutes for each study NIBP 
measurement), after which no further research procedures will be performed. General 
anesthesia is widely recognized as a neuromodulator with potential neurotoxic effects; 19, 20, 21, 22, 
23, 24 however, it is widely believed that prudent use of general anesthesia in pediatric patients 
does not pose significant acute or chronic risks to patients at routine clinical dosages and non-
repeating administrations. 19, 25, 26 As used in this study, the devices and study procedures are not 
expected to pose significant risks to participating subjects beyond those of their clinically 
indicated catheterization procedure. 
2.3.3. General Controls and Risk Mitigations (all subjects) 
No medicinal agents, including anesthesia and sedatives, are specifically required by the study; 
however, being in the study will not prevent subjects from receiving medications that are 
otherwise prescribed for their procedure. Extension of administration of general anesthesia 
consisting of approximately 25 minutes is foreseeable. Because repeat anesthesia 
administration has been identified as a central risk factor, particularly amongst pediatric 
subjects, 25 the study will not enroll any subject aged greater than 29 days but less than 12 years 
of age that has recently received anesthesia outside of the study within the last 3 months. 
Additionally, no subject will be allowed to participate more than once to mitigate any possible 
risks associated with repeat anesthesia administrations.  
3. 
RESEARCH DEVICE AND/OR PRODUCT 
3.1. Identification and Description of Research Device/Product 
3.1.1. PSM and PDM Multiparameter Hemodynamic Acquisition Modules (NIBP 
Measurement Devices) 
The blood pressure measurement functions of two commercially available multiparameter 
hemodynamic acquisition add-on modules, the Patient Data Module equipped with the 
DINAMAP® SuperSTAT algorithm (PDM-SuperSTAT) and the Patient Side Module equipped with 
Datex-Ohmeda GE algorithm (PSM-Datex-Ohmeda) (Fig. 1), are being investigated in this study. 
The PDM and PSM devices are hardware add-ons that are compatible with the CARESCAPE B650 
patient monitor as well as several other GEHC patient monitor products (not under study). Both 
the PDM and PSM acquisition modules are designed to enable the use of special software 
algorithms on existing patient monitors, thus allowing additional function on existing patient 
monitoring equipment without the need to purchase entirely new patient monitors. One of the 
capabilities of these devices is to allow NIBP measurement, which are determined using 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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oscillometric NIBP algorithms in the acquisition module. Using raw data collected by air-filled 
occlusive cuff on the patient’s body that is attached to the patient monitor, this software on the 
patient acquisition module allows existing patient monitors to report NIBP. Both the DINAMAP® 
SuperSTAT and Datex Ohmeda GE have been shown to satisfy ANSI/AAMI SP10-2002 and SP10A-
1996 American National Standard for Electronic or Automated Sphygmomanometers standards. 
 
 
Figure 1 – PSM (Datex-Ohmeda GE) and PDM (DINAMAP® SuperSTAT) hemodynamic acquisition modules for the 
CARESCAPE Monitor B650.  
3.1.1.1. 
Patient Data Module (PDM) with DINAMAP® SuperSTAT Algorithm (PDM-SUPSERSTAT) 
The Patient Data Module (PDM) is a high-acuity mobile hemodynamic acquisition module 
designed to help eliminate gaps and ECG resets when moving patients. The device can interface 
with the Solar® and CARESCAPE module patient monitors at the bedside and can quickly snap 
into and provide power for a Transport Pro® monitoring device. The detachable PDM docking 
station interfaces to the module frame flex board, and the 10-pin connector provides the VSYS 
ePort supply voltage and the Ethernet communication lines to the PDM module. The PDM 
includes GE’s clinical algorithms, including 12SL™ 12-lead ECG, 12RL™ derived 12-lead ECG, GE 
EK-Pro four-lead arrhythmia analysis, GE DINAMAP® SuperSTAT non-invasive blood pressure, 
and Masimo® SET® or Nellcor® OxiMax® SpO2. PDM uses the DINAMAP® SuperSTAT NIBP 
measurement algorithm. 
The GxP-validated GEHC PDM Data Collection Module, which enables the digital collection of 
research data typically manually transcribed from the patient monitor may also be used in the 
procedure. The modified GEHC PDM Data Collection Module used the same technology as the 
commercial PDM module, but has additional GxP-validated data collection features that are 
intended for research use only (serving to minimize potential errors or biases due to manual 
transcription from the patient monitor) to allow data output.  This software program is not 
otherwise expected to produce any change in function of the commercially marketed patient 
module.   
GE DINAMAP® SuperSTAT NIBP Algorithm 
The GE DINAMAP® SuperSTAT algorithm is an oscillometric NIBP software algorithm that can 
work with lower signal levels while still maintaining accuracy. 12  It is an enhancement of the 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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predicate DINAMAP® algorithm.  It uses the step-deflate technique to help guarantee that the 
highest quality signals are being used to estimate blood pressure. The main advantage of 
SuperSTAT over its predecessor is enhanced curve fitting of the oscillometric envelope data to 
smooth noisy data and reduce the number of steps needed to make blood pressure estimates. It 
also has the superior ability to use electrocardiogram (ECG) timing to help qualify cuff pulses 
when irregular rhythm is present. The innovative GE DINAMAP® SuperSTAT algorithm supports 
speed, comfort and artifact rejection for virtually all types of patients, including neonates, 
geriatrics and hyper/hypotensive patients. 27 
Use of various signal quality measures is used to reduce the impact of noise. 28 , 29, 30 The GE 
DINAMAP® SuperSTAT algorithm has the ability to obtain an NIBP determination when the 
target pressure (Pt) is equal to, or even slightly below, the patient’s systolic pressure (PSYS). As 
shown in Figure 2a, this is accomplished through the use of the curve fit algorithm in the GE 
DINAMAP® SuperSTAT that enables the extrapolation of systolic pressure of up to approximately 
10 mmHg beyond the target pressure. Figure 2b shows a recording of an NIBP determination 
made with a computerized data collection system (DCS). The target pressure was set to 135 
mmHg and the GE DINAMAP® SuperSTAT algorithm correctly obtained the patient’s blood 
pressure (145/89). 12 
 
Figure 2 – (a) Extrapolation of Systolic Pressure with GE DINAMAP® SuperSTAT Algorithm and (b) Extrapolation of 
Systolic Pressure (BP = 145/89) 
3.1.1.2. 
Patient Side Module (PSM) with Datex-Ohmeda GE Algorithm (PSM-Datex-Ohmeda) 
The Patient Side Module (PSM) is compatible with many CARESCAPE® platforms as well as many 
other legacy platforms. The PSM module is capable of measuring the same parameters as the 
PDM module, with the exception of CO measurement. The PSM connector is part of the modular 
frame flex board, and the PSM connector provides the +15 VMOd PSM supply voltage and the 
RS-485 communication lines to the PSM module. PSM uses the Datex-Ohmeda GE NIBP 
measurement algorithm. The PSM has a venous stasis mode that can be manually initiated. The 
venous stasis mode initiates inflation and holds a constant pressure in the cuff to assist venous 
cannulation. 
Datex-Ohmeda GE Algorithm 
The Datex-Ohmeda GE algorithm is an established oscillometric algorithm that uses 
contributions from a range of frequencies to determine explicit values for parameters, such as 
blood pressure. 31 Rather than using a step-wise process (as in DINAMP® SuperSTAT), the Datex-
Ohmeda GE algorithm is used to acquire and process continuous raw data signals, such as those 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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obtained from an occlusive cuff during NIBP procedures. 32 The Datex-Ohmeda GE algorithm has 
been successfully used to monitor blood pressure in adult and pediatric patients and to predict 
vascular change and fluid loading. 13 
3.1.2. Patient Monitoring Devices 
3.1.2.1. 
CARESCAPE Monitor B650 
The CARESCAPE Monitor B650 (Fig. 3) includes standard docking for both the PSM and PDM 
hemodynamic modules. The CARESCAPE Monitor B650 is a flexible patient monitoring solution 
that is highly configurable and provides many monitoring possibilities with a flexible software 
licensing model. The CARESCAPE Monitor B650 will employ the most recent FDA cleared 
software version. The CARESCAPE Monitor B650 improves data integration and connectivity by 
directly linking to the GE Healthcare CARESCAPE portfolio of monitoring products―including 
bedside, central station and transport monitors―as well as existing GE Healthcare monitors and 
peripheral third-party devices. 
 
Figure 3 – Image showing the anterior (screen) and posterior (ports) view of the CARESCAPE 
monitor 650. PSM module is installed (left) and PDM acquisition module is installed (right) 
 
Figure 4 - Parameters and Modules for the Patient Side Module (PSM) and Patient Data Module (PDM) 
multiparameter hemodynamic acquisition modules from the GEHC CARESCAPE Monitor B650 Cut Sheet 33  

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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The CARESCAPE Monitor B650 has the following features: 
• 
15 in (diagonal) display 
• 
Active matrix color TFT LCD 
• 
1024 x 768 pixels (XGA) resolution 
• 
0.625, 6.25, 12.5, 25, 50 mm/sec sweep speed 
• 
Automatic and manual configurations 
• 
8 individual traces, with up to 14 with overlays and insets 
Developed with tens of thousands of hours of testing, the CARESCAPE Monitor B650 is intuitive 
to use. It enables efficient clinical decision-making via the following benefits 34:  
• 
Ease of clinical customization: To tailor the monitor for a specific patient condition or 
caregiver specialty, clinicians can simply use customized patient profiles within the 
monitor or plug in a new clinical measurement module. Traditionally, caregivers needed 
to move a different, specialized patient monitor to the point of care. 
• 
Enhanced usability: The CARESCAPE Monitor B650 includes an intuitive touch screen 
interface, as well as a barcode reader, enabling fast and secure patient data input. From 
the CARESCAPE Monitor B650, caregivers can view data and alarms from remote 
monitors without leaving the patient’s bedside.  
• 
Ease of installation and training: With the CARESCAPE Monitor B650, a hospital can 
easily duplicate hospital-specific clinical settings across all patient monitors on the 
network. Because the CARESCAPE Monitor B650 leverages similar software interfaces as 
other devices on the GE Healthcare enterprise monitoring platform, training can be 
streamlined. 
• 
Monitor mobility: The monitor can run via a wireless local area network and can be 
battery operated, reducing the need for wall cables. The CARESCAPE Monitor B650 
continuously transmits data to the central station, even when the monitor is moved 
while connected to a patient. 
The CARESCAPE Monitor B650 combines the strong clinical heritage of Datex-Ohmeda 
anesthesia and Marquette Electronics cardiac expertise, providing a significant level of 
backwards compatibility that allows hospitals to leverage prior technology and training.  
While the CARESCAPE Monitor B650 equipped with the DASH® 4000 may be used in the study, 
use of these patient monitoring devices will not be required for procedures conducted using the 
GxP-validated GEHC PDM Data Collection Module, which enables the digital collection of 
research data typically manually transcribed from the patient monitor.  
GE Critikon SOFT-CUF® and CLASSIC-CUF® blood pressure cuffs (Fig. 5) are commercial cuffs 
cleared for use with the CARESCAPE Monitor B650.  Similarly, all hoses are standard commercial 
hoses cleared for use with the patient monitor system. 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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Figure 5 – Five sizes of GE CRITIKON SOFT-CUF® arm occlusive blood pressure cuffs for infants, children, pediatric 
patients, adolescents, and adults (left) as well as one size of thigh cuff (left, brown); five sizes of GE CRITIKON 
CLASSIC-CUF® occlusive blood pressure cuffs for neonates are shown on the right. 
3.1.3. Patient Monitoring Devices: DASH® 4000 
The DASH® 4000 is a commercially available multifunction patient monitor that can be used to 
record IBP. The full featured Dash® 4000 monitor offers a 10.4-inch screen and is a 
comprehensive portable bedside monitoring solution.   
 
Figure 2– (a) Front view and (b) side view of the DASH® 4000 reference standard device for measuring intra-
arterial blood pressure. 
The DASH® 4000 Patient Bedside Monitor used for this study is a monitor that obtains many 
vital signs for patients.  It is mainly used in patient care areas of higher acuity.  The monitor is 
used for obtaining both invasive and noninvasive blood pressures, ECG tracings, and other vital 
signs.  The DASH® 4000 used in this study is considered investigational because the unit is 
equipped with DC-COLLECTOR and DC-EDIT, special additional software programs that can send 
ECG, invasive blood pressure, and noninvasive blood pressure waveforms in addition to other 
relevant blood pressure data to data collection system (DCS) on a laptop computer.  The only 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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function of DC-COLLECTOR and DC-EDIT is to allow data output, and these software programs 
are not otherwise expected to produce any change in function of the commercially marketed 
patient monitor.  Although the device is not in direct contact with the patient, it is connected to 
the patient via a fluid filled catheter to a pressure transducer to collect the arterial (invasive) 
blood pressure data. 
The Dash® 4000 patient monitor features innovative parameter technology, 27 as follows: 
• 
GE EK-Pro four lead arrhythmia analysis: The GE EK-Pro™ clinical algorithm provides 
advanced atrial fibrillation detection and alarming. Early and accurate identification of 
AFib may help prevent this arrhythmia from becoming chronic. 
• 
GE 12SL simultaneous 12 lead ECG detection: The 12SL™ algorithm provides improved 
P-wave detection, age and gender-specific interpretation and 12 lead buffer (if MUSE® is 
offline, up to 12 ECGs are stored). 
The DASH®400 used in this study is equipped with validated non-commercial tools DC-EDIT and 
DC-COLLECTOR that allow output of waveform data and parameters to a computerized Data 
Collection System (DCS).  
3.2. Regulatory Status 
The PSM and PDM acquisition modules and CARESCAPE B650 used in this study are 
commercialized in the United States and have been cleared by the US FDA. Because the PSM 
module is not currently cleared for using in neonates or infants under 5 kg (approximately 11 
lbs.), no patients in this age range will be examined with PSM in this study. The PDM device is 
cleared for use in patients of all ages. When possible, sites may also use the modified GxP-
validated GEHC PDM Data Collection module, which uses the same technology as the 
commercially available PDM module with additional features to enable digital collection of 
research data. The GxP-validated PDM Data Collection Module is considered a pre-market 
device used for research purposes only, and is not intended to be commercialized.  
The DASH® 4000 patient monitors are commercialized; however, when the Good Processing 
Tools (GxP) validated DC-EDIT and DC-COLLECTOR are equipped on the DASH®4000 the device is 
considered non-commercial (investigational) and is to be used for research purposes only. 
Notably, DC-EDIT and DC-COLLECTOR have been validated for use in clinical data collection for 
the purpose of regulatory submissions. The results of the current study may be used as part of 
regulatory submissions to the US FDA or other global regulatory bodies to support the use of the 
investigational NIBP software algorithms with other patient monitoring systems. 
3.3. Risk Category/Rationale (US Only) 
The CARESCAPE Monitor B650, acquisition modules (PDM and PSM), and peripheral cuffs and 
hoses used in this study are cleared for commercial use and will be used as intended in their 
labeling. All commercial devices are considered to be IDE Exempt per 21 CFR 812.2(c)(2).  The 
DASH® 4000 is a commercial device; however, when equipped with the GxP validated non-
commercial DC-EDIT and DC-COLLECTOR tools for data output it is to be used for research 
purposes only. Similarly, the GxP-validated PDM Data Collection Module used in place of manual 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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transcription from patient monitors is intended for research use only.  DC-EDIT and DC-
COLLECTOR (for DASH®4000) as well as the PDM Data Collection Module tools are not expected 
to impact the function of other devices or the integrity of the study, but instead are intended 
solely to enable digital collection of study data while minimizing biases associated with manual 
transcription of data. When using a DASH® 4000 equipped with DC-EDIT and DC-COLLECTOR or 
the PDM Data Collection Module in place of manual data transcription from patient monitors, 
the  devices  investigated in this research study are considered non-significant risk devices per 
the 21 CFR 812.3 definition: 
1. it is not intended as an implant; 
2. is not purported or represented to be for a use in supporting or sustaining human life; 
3. is not for a use of substantial importance in diagnosing, curing, mitigating, or treating 
disease, or otherwise preventing impairment of human health; and 
4. it does not otherwise present a potential for serious risk to the health, safety, or welfare 
of a subject. 
3.4. Device/Product Classification and Rationale 
The PSM acquisition module (using Datex-Ohmeda GE for NIBP assessment) is cleared for 
commercial use under US FDA 510(k) K062576 (2006), and the PDM acquisition module (using 
DINAMAP® SuperSTAT for NIBP assessment) is cleared for commercial use under US FDA 510(k) 
K071073 (2007) as a non-invasive blood pressure measurement system (DXN) under CFR 
870.1130. 
When available, the pre-market PDM Data Collection GxP Module may be used in place of 
manual transcription from patient monitors using the commercial PDM module, enabling 
research data to be collected digitally. The PDM Data Collection GxP Module has been qualified 
per Good Processing Tools (GxP) by GE Healthcare for collection of ECG, blood pressure data in 
clinical settings,  is considered investigational and intended for research use only. 
The CARESCAPE Monitor B650 is a Class II medical device classified as a Patient Physiological 
Monitor (with arrhythmia detection or alarms) by the US FDA and cleared under 510(k) K131223 
(2013). The most recent FDA cleared software version for the CARESCAPE Monitor B650 at the 
time of the study will be used on the CARESCAPE Monitor B650. 
The DASH® 4000 patient monitor is a Class II medical device classified as a Patient Physiological 
Monitor by the US FDA and cleared under 510(k) K073462 (2008). Non-commercial DC-EDIT and 
DC-COLLECTOR tools used on the DASH®4000 have been qualified per Good Processing Tools 
(GxP) by GE Healthcare for collection of ECG and arterial data in clinical settings). When 
equipped with these tools, the DASH® 4000 patient monitor will be considered investigational. 
All occlusive blood pressure cuffs and hoses used in this study have been cleared for use with 
their respective patient monitors in this study. 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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3.5. Device/Product Issuance and Replacement 
The Sponsor will issue the following devices to the investigational site(s) for the purpose of this 
study: 
• 
Patient monitors (DASH® 4000 and CARESCAPE Monitor B650 with the most recent 
software versions installed) with the appropriate software versions installed. DASH® 
4000 patient monitors will be equipped with DC-EDIT and DC-COLLECTOR and labeled as 
investigational (for research purposes only). 
• 
PSM and PDM acquisition modules for the CARESCAPE Monitor B650 with appropriate 
software versions already installed, or, based on availability, the PDM Data Collection 
Module labeled as investigational (for research purposes only). 
• 
 
• 
Required cuffs, hoses, ECG equipment, and wired connector s 
• 
Laptops for use as IBP data collection systems (DCS) with appropriate software installed 
to capture physiologic and waveform data outputted from DASH® 4000 patient 
monitors equipped with DC-EDIT and DC-COLLECTOR 
• 
Standard digital calibrated reference manometer(s) with error limit(s) of 1 mmHg (0,1 
kPa) 
The investigational site will select and provide all required catheterization equipment and 
transducers per their standard of care and applicable hospital policy. The study will not 
influence the hospital’s selection of catheterization and/or transducer devices. 
The Sponsor will record the manufacture, serial number, and last calibration for all manometers 
and the size (cm x cm) for all cuffs used. 
3.6. Disposition of the device/product  
All devices issued to the site by the Sponsor will be returned to the Sponsor after the study is 
completed. All identifiable patient data is intended to be removed from the devices prior to 
removal from the site. The Sponsor may provide the site with instructions for disposal of non-
reusable devices or device components. All study devices provided by the Sponsor will be used 
only for study-related activities. 
4. 
OBJECTIVES OF RESEARCH STUDY 
4.1. Hypothesis 
This is a study conducted to satisfy the ISO 81060-2:2013 standard for two NIBP devices (PSM-
Datex-Ohmeda and PDM-SuperSTAT) and, as such, does not require a statistical hypothesis. The 
Pass/Fail criteria are described in Section 9.5 - Pass/Fail Criteria. 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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4.2. Study Objectives 
4.2.1. Primary Objective: 
The primary objective of the study is to determine if the PSM-Datex-Ohmeda and PDM-
SuperSTAT NIBP measurement devices provide accurate blood pressure measurements in all 
indicated patient populations (neonates, children, pediatrics, adolescents and adults, and 
special populations) according to the definitions set forth by ISO 81060-2:2013. 
4.3. Study Endpoints 
4.3.1. Primary endpoints: 
Per patient, NIBP and IBP endpoints will be 
collected for: 
• 
Systolic BP (mmHg) 
• 
Diastolic BP (mmHg) 
• 
NIBP and IBP Mean Arterial 
Blood Pressure (MAP) 
Per patient, for NIBP only: 
• 
Accuracy, determined according 
to ISO 81060-2:2013  
 
4.3.2. Secondary endpoints: 
Per patient, endpoints will be collected for: 
• 
Baseline data, including demographics 
• 
Per-procedure data 
• 
Static calibration of device 
5. 
DESIGN OF RESEARCH STUDY 
5.1. Type of Research Study 
This is an open-label, multi-site, dual arm, prospective study with demographics-based 
stratification quota. 
Open-Label 
 
Patients or patients’ legal representatives and investigators will have 
knowledge of all treatments 
Blinded  
 
 
Double-Blinded 
 
 
 
Single-site  
 
 
Multi-site 
 
The study will be conducted at three (3) sites 
 
Randomization 
Procedure: 
 
 
Not randomized: 
 
Patients will be consecutively assigned to PDM-SuperSTAT or PSM-
Datex-Ohmeda groups based on demographics-based stratification 
Single arm 
 
 
Comparator 
 
 
Parallel 
 
 
Crossover 
 
Patients will receive NIBP and IBP assessments, with NIBP type (PDM-
SuperSTAT or PSM-Datex-Ohmeda) determined by study arm. Each 
patient will act as their own control for NIBP vs. IBP comparisons 
Prospective 
 
Patients are enrolled and then undergo study procedures. 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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5.2. Controls and Minimization of Bias 
Patients will be enrolled consecutively into the PDM-SuperSTAT study arm and, if stratification 
quotas are met, then into the PSM-Datex-Ohmeda study arm until each arm’s stratification 
quota reaches its minimum allotment. Thereafter, patients may be enrolled consecutively 
without regard to stratification quota until the minimum total patient population is reached. 
Consecutive enrollment is designed to limit selection bias. The devices with algorithms and 
required peripherals, including cuffs and hoses, will be provided by the Sponsor to ensure 
consistency between procedures and limit possible bias due to variations in storage, handling, or 
lot numbers. 
6. 
STUDY SUBJECTS 
6.1. Subject Population 
The study will include neonates with indwelling femoral, radial, or umbilical arterial monitoring 
lines and infant, pediatric, adolescent, and adult subjects requiring non-emergent surgery 
involving aortic catheterization (including chronic atrial fibrillation patients among adults and 
adolescents). 
6.2. Protection of Vulnerable Subjects 
The information collected in this study could not have been obtained in a less vulnerable, 
consenting population, necessitating the use of minor patients. Adolescent, pediatric, and 
neonatal patients will be recruited and enrolled according to all US FDA, ISO 14155:2011 GCP, 
and other applicable local requirements for protection of vulnerable subjects. Special measures 
will be taken to protect the rights of these vulnerable study participants and to shield them from 
undue risk.  Study procedures for pediatric and neonate subjects will be modified to minimize 
interruption in normal medical care, which includes additional limitations on sampling frequency 
beyond the minimums suggested by ISO 81060-2:2013 (as shown in Table 2) for the general 
population. This is done to ensure minimal risk for participating subjects. 
6.3. Number of Subjects 
The total minimum enrollment for the two study arms is 83 total evaluable patients (maximum 
of 200 patients), as follows:  
1. PDM-SuperSTAT Arm (NPDM): 45 evaluable patients with GE DINAMAP® SuperSTAT 
algorithm (PDM Module) on CARESCAPE Monitor B650, to achieve a total target of ≥150 BP 
data pairs in patients ≥3 years old (up to 10 paired measurements per subject) and ≥150 BP 
data pairs in patients <3 years old (as described in Table 2). 
2. PSM-Datex-Ohmeda Arm (NPSM): 29 evaluable patients with Datex-Ohmeda algorithm (PSM 
module) on CARESCAPE Monitor B650, to achieve a total of ≥150 BP data pairs in patients ≥3 
years old (up to 10 paired measurements per subject) and ≥150 BP data pairs in patients <3 
years old (as described in Table 2). 
 
 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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6.3.1. Stratification of Subjects 
Subject enrollment will be stratified based on prospective criteria to ensure diversity in the 
population, as described in ISO 81060-2:2013 and set forth in Table 1. Patients will be enrolled 
concurrently in both arms until all minimum quotas are reached, and thereafter up to the 
maximum enrollment for the study. Incomplete/non-evaluable datasets, as determined by the 
Sponsor, will not be considered to satisfy minimum requirements in Table 1. Additionally, 
multiple cuff sizes will be used, including a minimum of 1/(2 x n) per stratification group (except 
for the children/infants/neonates group), where n is the total within a stratification group able 
to be tested using the cuff in accordance with its labeling (Table 1). 
Table 1 – Summary of Patient Enrollment Stratification by Characteristics 
Enrollment Stratification 
Minimum 
Total in PDM-
SuperSTAT 
arm 
Minimum Total 
in PSM- 
Datex-Ohmeda 
arm 
Age (years) 
requirement 
Weight (g) 
requirement 
Gender 
(M/F) 
Minimum 
number of 
patients (n) 
Adults and Adolescents 
(General population) b 
15 total 
patients 
15 total patients 
>12 yr 
(no weight 
requirement) 
F# 
n ≥ 5 
>12 yr 
M# 
n ≥ 5 
Adults and Adolescents 
Chronic Atrial Fibrillation b 
7 total 
patients 
- 
>12 yr 
 
M or F# 
 
 
n ≥ 7 
 
Pediatrics 
5 total 
patients 
5 total 
patients 
≥3 AND ‹12 yr 
F# 
n ≥ 2 
≥3 AND ‹12 yr 
M# 
n ≥ 2 
Children/Infants/ 
Neonates 
18 total 
patients 
- 
 
≥1 yr AND <3 yr 
M or F 
n ≥ 3 
>29 days AND <1 yr 
M or F 
n ≥ 3 
(no age 
requirement)* 
< 1000 g 
M or F 
n ≥ 3 
1000-2000 g 
M or F 
n ≥ 3 
>2000 g 
M or F 
n ≥ 3 
- 
9 total 
patients 
≥1 yr AND <3 yr 
>5 kg (~11 lbs) a 
M or F 
n ≥ 3 
>29 days AND <1 yr 
>5 kg (~11 lbs) a 
M or F 
n ≥ 3 
(no age 
requirement)*  
>5 kg (~11 lbs) a 
M or F 
n ≥ 3 
TOTAL 
45 TOTAL 
29 TOTAL 
 
Abbreviations: M = male; F = female; n, number of patients 
* No age requirement within the children/infant/neonates category may include subjects aged birth to <3 yrs 
# Investigators should equitably represent male and female patients, which must each make up a minimum of 30% of the final population upon 
completion (i.e. at least 30% male and 30% female, the remaining  may be either male or female based on enrollment). 
Important: Additional Stratification requirements 
a Only patients weighing >5 kg (approximately 11 lbs) can be examined with PSM-Datex-Ohemda under the current labeling 
b Among adult/adolescents, at least 10% should have baseline systolic BP of  ≤100 and ≥160 as well as diastolic BP of ≤ 70 and ≥ 85 mmHg 
 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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6.4. Inclusion Criteria  
Subjects will be included that: 
1. Are aged >29 days requiring clinically indicated non-emergent heart catheterization OR aged 
≤29 days with placed or scheduled placement of an indwelling femoral, radial, or umbilical 
arterial monitoring line; 
2. Have an upper limb (right OR left side) that fits a cuff size of the device (circumference 
ranging 3 cm to 40 cm) OR have a thigh (right OR left side) that fits a cuff size of the device 
(circumference ranging 38 to 50 cm); 
3. Are expected to be able to provide blood pressure measurements using both IBP and NIBP; 
4. Are able and willing to provide written informed consent or have a legally authorized 
representative willing to provide written informed consent with assent from minor patients, 
as required by IRB policy. 
6.5. Exclusion Criteria  
Subjects will be excluded that: 
1. Have previously participated in this study (no subject may participate more than once). 
2. Exhibit signs or symptoms or have a current diagnosis of peripheral vascular disease in 
upper AND/OR lower limbs; 
3. Have current, uncontrolled circulatory shock; 
4. Exhibit injuries, deformities, intravenous lines, or other abnormalities that, in the opinion of 
the investigator, may prevent proper cuff application or functioning; 
5. For women of child-bearing potential, are currently pregnant, suspected to be pregnant, or 
are currently lactating; 
6. Have any condition that could interfere with the subjects ability to tolerate the procedure, 
including having a maximum of 4 fast flushes (adult, adolescent, or pediatric patients aged 
>29 days) or 1 fast flush (neonates aged <29 days); 
7. If aged greater than 29 days but less than 12 years of age, have previously had any clinical or 
research procedure requiring general anesthesia in the last 3 month period; 
8. If aged greater than 29 days but less than 12 years of age, are expected to require more 
than three (3) total hours of continuous general anesthesia for the scheduled procedure 
(including clinically necessary anesthesia and anticipated 25 minute extension for study 
purposes). 
 
 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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6.6. Screening Subjects for Enrollment 
There are three (3) investigational clinical sites involved in this clinical trial. Patients will be 
screened for enrollment by the investigational site according to their standard procedure, in 
accordance with IRB policy. All patients will be consecutively screened and enrolled first into the 
PDM-SuperSTAT group if eligible. Remaining patients will then be screened for the PSM-Datex-
Ohmeda group. All patient enrollment will be conducted according to the stratification criteria 
and inclusion/exclusion criteria. 
7. 
PROCEDURES FOR RESEARCH STUDY 
7.1. Setup Procedures 
7.1.1. IBP Data Collection on the Data Collection System (DCS) 
The PDM Data Collection Module may be used to collect research data (based on availability) for 
PDM procedures, else IBP and ECG data will be collected using a DASH® 4000 patient monitor 
with the hardware and software tools to connect to a computerized data collection system 
(DCS) housed on a Sponsor-provided laptop computer. A laptop will be connected for electronic 
data capture, when GxP-validated data capture tools are used. The investigator is responsible 
for setting up the data collection according to the “Setup of Data Collection” section of the 
Device Set-Up Manual provided by the Sponsor. For applicable procedures, the control panel for 
the DASH® 4000 patient monitor is shown in the “DASH® 4000 Control Panel” section of the 
section of the Device Set-Up Manual provided by the Sponsor, which provides details on user 
setup and operation of the DASH® 4000 patient monitor. 
The patient procedure for IBP setup is shown in the “IBP Setup” section of the Device Set-Up 
Manual provided by the Sponsor. Similarly, the Device Set-Up Manual provides instructions for 
setup and use of the PDM Data Collection Module for electronic data capture during PDM 
procedures. 
7.1.2. NIBP Data Collection 
NIBP will be recorded on a commercial CARESCAPE Monitor B650 with most recent commercial 
software version installed. NIBP data will be transcribed by hand from the display of the 
CARESCAPE B650 monitor onto the Sponsor-provided Case Report Form (CRF) when the PDM 
Data Collection Module is not available. When the PDM Data Collection Module is available, 
data collection may be performed electronically using this tool. 
For patients in the PDM-SuperSTAT arm of the study, NIBP will be measured with a CARESCAPE 
Monitor B650 equipped with a PDM acquisition module or the GxP PDM Data Collection 
Module. For patients in the PSM-Datex-Ohmeda arm of the study, NIBP will be measured with a 
CARESCAPE Monitor B650 equipped with a PSM acquisition module.  
 
 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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7.2. Study Procedures 
7.2.1. Baseline Examination 
For enrolled patients that have provided informed consent the following baseline information 
will be collected on CRFs after informed consent requirements have been satisfied and before 
the procedures are performed: 
1. 
Demographics (Age and Gender) 
2. 
Gestational Age at Birth (for Neonates only) 
3. 
Height and Body Weight 
4. 
Relevant Medical History  
5. 
Physiological Condition (Stable/Unstable)  
6. 
Urine pregnancy test, if applicable (females of childbearing potential) 
7. 
Arm or Thigh Circumference (cm) 
8. 
Appropriate Cuff Brand (Critikon® Soft-Cuf or Classic-Cuf) and Size 
9. 
Baseline Non-Invasive Blood Pressure (NIBP), consisting of systolic blood 
pressure (SBP) and diastolic blood pressure (DBP)   
10. 
Location of NIBP Measurement (Arm/Thigh) and measuring circumstance 
11. 
Mean Arterial Pressure (MAP) 
12. 
Current medications 
13. 
Pulse rate 
7.2.2. Before the Procedure 
For each patient, the following procedure-specific information will be recorded on CRFs: 
1. 
Model and serial number for the DASH® 4000 (if applicable)  
2. 
Model and serial number for CARESCAPE B650 (if applicable)  
3. 
Model and serial number for the PSM or PDM acquisition module used 
4. 
Catheter cross-section, length, and trade name 
5. 
Trade name of pressure transducer 
6. 
Site/artery used for IBP measurements 
7. 
Monitor filter settings and recording settings, if applicable 
8. 
Identification of the observer making the recordings (name and position) 
9. 
Details of any special circumstances during measurement 
10. 
Pulse rate at the start of device evaluations 
11. 
Time and date of last manometer calibration 
Three ECG sensors will be placed with leads on the left and right arm and left leg connected to 
the DASH® 4000 or the PDM Data Collection Module 
Before each patient procedure, static calibration will be conducted for the IPB system to ensure 
measurement accuracy according to the “Static Calibration” section of the Device Set-Up 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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Manual provided by the Sponsor. Each system will be calibrated at 5 static pressures spread 
across the working range of the device to be tested, recorded as: 
1. 
Pressure for each of the 5 calibration static pressures tested 
2. 
Calibration completion status (success/fail) 
3. 
Descriptions of any errors during any static calibration procedure 
7.2.3. Patient Procedures 
Each patient will undergo intra-arterial aortic catheterization according to the standard of care 
at the investigational site. All tubing, transducers, and stopcocks will be filled with fluid and 
purged of all bubbles prior to data recording for IBP or NIBP in this study. If general anesthesia 
and/or other medicinal products are prescribed outside of the study, they will be administered 
according to the local standard of care prior to study measurements. 
Dynamic calibration will be performed in the beginning of each procedure according to the 
“Dynamic Calibration” section of the Device Set-Up Manual provided by the Sponsor.  For 
patients that the procedure will extended beyond one day, dynamic calibration will be 
conducted once each day prior to determinations. A maximum of 1 flush is to be conducted for 
patients aged <29 days. A maximum of 4 flushes may be conducted for patients aged ≥29 days. 
During calibration, values will be recorded for: 
1. Number of fast flushes 
2. Damping  coefficient 
3. Natural frequency 
For subjects less than 29 days of age, care will be taken to minimize disruption of care, and, 
when possible, procedures will be performed during times when feeding or other care is 
provided. 
7.2.4. Blood Pressure Assessments 
NIBP will be measured using the CARESCAPE Monitor B650 patient monitor equipped with an 
acquisition module (either PDM-SuperSTAT or PSM-Datex-Ohmeda, determined by study arm). 
IBP will be measured using the DASH® 4000 plus DC-COLLECTOR and DC-EDIT software. For PDM 
procedures where the PDM Data Collection Module is used for electronic data capture, this may 
be used in place of manual transcription from the patient monitor to paper CRFs. During the 
blood pressure assessments, values will be recorded for: 
1. Study Arm 
2. Time of first and last blood pressure measurement 
3. Systolic, Diastolic, Mean, Test Duration 
4. If the prescribed wait time was taken between tests 
5. Any measurements with no determination 
Both NIBP and IBP assessments will be conducted simultaneously, using either digital data 
recording tools (when available) or recorded by hand onto a paper Case Report Form (CRF). If 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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necessary, assistance will be provided by other study staff to ensure that accurate and 
simultaneous blood pressure data is recorded. 
IBP data will be continuously collected throughout the study.  
For cases where manual data collection of NIBP data is necessary, it will be recorded according 
to the following procedure: 
1. Use the patient monitor equipped with either PDM-SuperSTAT or PSM-Datex-Ohmeda 
according to the patient’s study arm to determine the patient's blood pressure. 
2. Clear the patient monitor memory of the previous determination and wait at least 3 min  
3. Have the observers using the reference IBP monitoring equipment (DASH® 4000) and the 
NIBP monitoring equipment (CARESCAPE Monitor B650 with either PSM or PDM) 
simultaneously record and determine the patient's blood pressure, as follows. 
a. Start continuous collection on the IBP DCS system at the same time as recording of 
NIBP begins 
b. Collect each NIBP measurement from the CARESCAPE Monitor B650 
4. Wait the appropriate amount of time between determinations (as defined in Table 2). 
5. Repeat steps 3 and 4 adhering to the requirements in Table 2 until the target number of 
recordings and determinations have been performed or the subject leaves the study. In the 
event that any blood pressure determination is not successful, the procedure may be 
repeated to achieve the target number of successful blood pressure determinations. No 
more than the maximal number of total blood pressure determinations as specified in Table 
2 will be performed on any patient. 
6. When all NIBP measurements are complete, stop the IBP data collection. 
For PDM procedures where the PDM Data Collection Module is used, data may be captured 
electronically instead of using the manual procedure according to the following procedure: 
1. Use the PDM Data Collection Module to determine the patient's blood pressure. 
2. Wait at least 3 min. 
3. Simultaneously record and determine the patient's blood pressure, as follows. 
a. Start NIBP measurement from the PDM Data Collection Module 
4. Wait the appropriate amount of time between determinations (as defined in Table 2). 
5. Repeat steps 3 and 4 adhering to the requirements in Table 2 until the target number of 
recordings and determinations have been performed or the subject leaves the study. In 
the event that any blood pressure determination is not successful, the procedure may 
be repeated to achieve the target number of successful blood pressure determinations. 
No more than the maximal number of total blood pressure determinations as specified 
in Table 2 will be performed on any patient. 
6. When all NIBP measurements are complete, stop the data collection. 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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The same number and type of determination should be performed whether the manual or digital PDM 
Data Collection Module is used. 
Table 2 – Number of Blood Pressure Assessments and Frequency 
Population 
Maximum 
Number of BP 
Determinations 
Target Number of 
Valid BP 
Determinations 
Frequency of 
Determinations 
Pediatric, Adolescents, 
and Adults (aged ≥ 3 
years) 
15 max attempts 
10 determinations 
At least 60 s between 
determinations  
Children & Infants (<3 
years old to >29 days 
old) 
10 max attempts  
10 determinations 
At least 60 s between 
determinations 
Neonates (‹ 29 days 
old) 
10 max attempts 
5-10 determinations 
At least 3 minutes 
between 
determinations (over 
max of 72 hours) 
 
7.3. Data Storage 
All digitally recorded data will be saved from the DCS folder to a Sponsor-provided external 
media (e.g., flash drive or CD), and the Investigator will confirm that all data is saved on flash 
drive or CD and stored in a secured area at the investigational site. When NIBP data  is recorded 
on paper case report forms, it will be stored in a secure area at the investigational sites.  
7.4. Withdrawal and Discontinuation Criteria 
The patient may withdraw from study participation at any time, for any reason without 
consequence. The Investigator may withdraw a patient at any time for any reason. The reasons 
for withdrawal and discontinuation for any patient shall be recorded. These will be reported to 
the Sponsor. The EC/IRB should be notified per their notification of patient withdrawal policy. 
Data collected up until the time of withdrawal may still be disclosed to the Sponsor as part of 
this study to ensure the integrity of research data. 
Continuation and discontinuation of enrollment in any stratification group will be made at the 
discretion of the Sponsor in the context of applicable regulatory and standards requirements, 
and the Investigator will be notified by the Sponsor upon such a determination. 
8. 
TRAINING PLAN 
8.1. Training Plan for Research Device/Product 
All device evaluations will be conducted by trained observers that understand blood pressure 
measurement and have been recently trained in blood pressure measurement. Training for 
clinical investigators will be provided by the Sponsor to ensure that procedures are conducted in 
accordance with procedures outlined in this protocol. The current commercially available GEHC 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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CARESCAPE Monitor B650 User Manual, DASH® 4000 User Manual, and a Sponsor-provided 
Device Setup Manual for this study will be provided to the investigational site. The Sponsor may 
also provide additional training on these materials to ensure proper device usage. 
8.2. Training Plan for Protocol 
All investigators and study staff will be provided training on the protocol and procedures prior to 
study initiation. Any investigator or study staff may request additional training to ensure that 
study procedures are conducted in accordance with the protocol. 
9. 
DATA ANALYSIS AND STATISTICS 
9.1. Statistical Analysis Methods 
9.1.1. Analysis Populations 
Separate analysis will be performed for PSM-Datex-Ohmeda and the PDM-SuperSTAT arms per 
requirements of the ISO 81060-2:2013 standard. Analyses will be conducted for the following 
populations: 
• 
adults, adolescents, and pediatric patients, who are ≥ 3 years old and chronic atrial 
fibrillation patients (PDM-SuperSTAT arm) 
• 
adults, adolescents and pediatric patients, who are ≥3 years old (PSM-Datex-Ohmeda 
arms) 
• 
neonates and children <3 years of age (PDM-SuperSTAT arm) 
• 
children <3 years of age and weigh over 5 kg (11 lbs) (PSM-Datex-Ohmeda arm) 
If deemed necessary by the Sponsor, when the measurement accuracy is compromised in a sub-
population, affected sub-populations may be excluded from analysis 
9.2. Determining Reference Invasive Blood Pressure Per ISO 81060-2:2013 
First, the mean and the standard deviation of the invasive blood pressures derived from the IBP 
wave recordings during a NIBP determination will be calculated; and the range of reference 
invasive blood pressure will be determined as mean ±1 standard deviation (SD) of the IBPs. The 
same method will be used for both systolic and diastolic blood pressures. Calculation of 
reference IBP from IBP wave recordings is not part of the statistical analysis. Data may be 
excluded for analysis when the range of invasive systolic BP is wider than 20 mmHg or when the 
range of invasive diastolic BP is wider than 12 mmHg, as such that analysis is performed in 
accordance with ISO 81060-2:2013. 
9.2.1. Analysis of Blood Pressure Measurement Error 
The BP measurement error of the investigational device will be determined as follows: 
• 
If the value obtained from the investigational device lies within the range of 
reference IBP, an error of 0 mmHg will be assigned to this determination. 
• 
If the value obtained from the investigational device lies outside the range of 
the IBP, the error for this determination will be calculated by subtracting the 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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adjacent limit of the IBP range from the value of the NIBP determination (∆ = 
NIBP - IBP).  
Then, mean and SD will be calculated from the errors of each determination of each patient 
using the following formulae, and will be compared to the acceptance criteria, i.e., mean  5 
mmHg and SD  8 mmHg. Percentages of measurements with errors within 5 mmHg, 10 mmHg, 
and 15 mmHg will also be calculated.  
 Mean:                 
 
 SD:                     
 
 
In addition, Bland-Altman plot will be presented for the measurement agreement between NIBP 
and reference IBP. The ‘average’ (x-axis) represents the average of the blood pressure from the 
investigational device and the mean reference IBP value. The ‘difference’ (y-axis) is the blood 
pressure measurement difference calculated as ∆=NIBP- mean IBP. 
Population mean bias, between-subject variance, within-subject variance, and limits of 
agreement will be calculated for the measurement difference using Bland-Altman method as 
described in the article “Agreement Between Methods Of Measurement With Multiple 
Observations Per Individual“ by Bland and Altman in 2007 Journal of Biopharmaceutical 
Statistics. 
9.2.2. Effect of Arm Circumference on Blood Pressure Measurement Error 
A scatter plot of the percent difference in blood pressure measurement over arm size will be 
presented to evaluate the effect of arm size on measurement error. The percent difference will 
be calculated as: 
 
 
 
This analysis will be done for systolic and diastolic blood pressure separately by study arm. 
9.2.3. Summary of Blood Pressure Measurement 
Number of NIBPs taken from each subject, and total number of NIBPs will be summarized for 
each analysis population by study arm.  
9.3. Analysis of Subject Characteristics 
The following subject characteristics data will be summarized using descriptive statistics if 
applicable per standard requirements for each analysis population by study arm. Continuous 
Percent Different = 
Difference between NIBP and Mean Reference IBP 
Average of NIBP and Mean Reference IBP 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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variables will be described using mean, standard deviation, median, minimum and maximum. 
Categorical variables will be described using count and percentage. 
• 
Number of Adult/adolescents/children/atrial fibrillation patients 
• 
Number of patients <1000g, 1000-2000g,>2000g in weight 
• 
Number of patients <29 days, ≥29 days and < 1 year of age, ≥ 1 year and < 3 years 
of age, ≥ 3 year and ≤ 12 years of age 
• 
Number of patients over 5 kg (11 lbs) and meet one of the following: ≥29 days 
and < 1 year of age, ≥ 2 year and < 3 years of age       
• 
Gender 
• 
Height and weight 
• 
Arm Size 
• 
Age 
• 
Adult and adolescent subjects with mean invasive systolic blood pressure ≥ 160 
mmHg 
• 
Adult and adolescent subjects with mean invasive systolic blood pressure ≤ 100 
mmHg 
• 
Adult and adolescent subjects with mean invasive diastolic blood pressure ≥ 85 
mmHg 
• 
Adult and adolescent subjects with mean invasive diastolic blood pressure ≤ 70 
mmHg 
• 
Number of subjects tested on each cuff size 
• 
Arterial sites where IBP was taken 
• 
Heart rate 
9.3.1. Data Exclusion 
The following NIBP data will be excluded from analysis: 
• 
NIBP data from a subject if the range of reference systolic blood pressure is 
more than 20mmHg or the range of reference diastolic blood pressure is more 
than 12 mm Hg, or as specified per ISO 81060-2:2013 standard; 
• 
Measurements beyond 10 valid measurements for each subject;  
• 
Isolated premature ventricular contractions (PVC) will be addressed by 
removing the pressure associated with the PVC and the following compensatory 
beat.  The PVC will be identified through analysis of the ECG waveform 
associated with the PVC and pulses. This is done during calculating IBPs from the 
IBP wave form, not in the statistical analysis. 
9.4. Interim Analysis 
No interim analysis is planned. As necessary for study conduct, engineering, and/or regulatory 
purposes, study data may be accessed and, if necessary, reported by the Sponsor prior to 
closure of the study.  

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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9.5. Handling of Missing Data  
Every effort will be made to obtain complete data. Data analysis will be based on collected data.  
Missing data will not be imputed using any imputation methods. Missing data is not expected 
for blood pressure values because up to 15 blood pressure determination procedures will be 
allowed, if necessary, to obtain 10 blood pressure recordings, thus minimizing the likelihood of 
missing data in IBP and NIBP blood pressure determination pairs. Any pair of blood pressure 
measurements with a missing value will be excluded from analysis. 
9.6. Pass/Fail Criteria of the Study 
The study will be considered to pass if a sufficient data set is collected to satisfy the 
requirements of ISO 81060-2:2013. 
10. 
DEVIATIONS 
10.1. Management of Protocol Deviations 
Deviations to the protocol may occur when necessary to protect the life or physical well-being of 
a patient. Except in an emergency, prior approval by the Sponsor is required for changes in, or 
planned deviations from this protocol. If these changes affect the scientific soundness or the 
safety and welfare of the patient, prior EC/IRB approval is also required. Planned Protocol 
Deviation documentation must be filed in the Site Study Regulatory Binder. 
There are two types of unplanned protocol deviations, critical deviations and non-critical 
deviations. All deviations must be documented and reported, the criticality of the deviation will 
determine the reporting path. 
Critical Deviations: Deviations that significantly affect the safety, efficacy, integrity or conduct of 
the study. These deviations must be reported to the Sponsor no later than 5 working days from 
awareness of occurrence and reported to the EC/IRB per the deviation reporting policy.  
If an Investigator uses a device without obtaining informed consent, the Investigator shall 
consider this a critical deviation and report the event to the Sponsor and the EC/IRB within 5 
working days of the occurrence  
Non-Critical Deviations: Protocol deviations that DO NOT significantly affect the safety, efficacy, 
integrity or conduct of the trial. These deviations must be documented on the Case Report Form 
Protocol Deviation page and will be reviewed by the study monitor. 
11. 
COMPLAINT HANDLING AND ADVERSE EVENT REPORTING 
11.1. Foreseeable Adverse Events and Device Effects 
The study procedure requires adding NIBP measurements to a patient’s procedure. While NIBP 
is non-invasive, there are some foreseeable risks associated with NIBP, as follows: 
• 
slight discomfort upon inflation of the cuff,  
• 
possible bruising, 
• 
petechial rash 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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• 
discoloration of the skin beneath the cuff 
• 
peripheral nerve injuries 
• 
skin avulsion 
• 
compartment syndrome 
• 
ischemia 
Whether or not the patient participates in the study, there are risks to having indwelling 
monitoring lines placed or having non-emergent aortic catheterization procedures with or 
without general anesthesia. To protect neonatal subjects, only subjects with existing indwelling 
monitoring lines will be enrolled, and no indwelling lines will be placed for study purposes. 
Foreseeable risks associated with these invasive procedures, as required for IBP, include: 
• 
Bruising 
• 
Bleeding 
• 
Heart attack 
• 
Stroke 
• 
Damage to the artery where the catheter was inserted that may require additional 
attention (pseudoaneurysm), including shear damage 
• 
Irregular heart rhythms (arrhythmias) 
• 
Allergic reactions to the dye or medication 
• 
Tearing the tissue of your heart or artery 
• 
Kidney damage 
• 
Infection 
• 
Blood clots 
• 
Ischemia 
• 
Air embolism 
• 
Potentially serious reactions to prescribed general anesthesia and/or sedatives 
While general anesthesia is not a requirement of this study, it is foreseeable that some patients 
undergoing aortic catheterization procedures will be incidentally administered prescribed 
general anesthesia and/or other sedatives during the study. Though general anesthesia is widely 
considered safe for routine clinical use, it is known to be a potent neuromodulator with 
potentially serious documented side effects. 19, 20, 22, 23, 24, 25, 26 This research involves extension of 
the procedure by approximately 25 minutes to collect data, which may incidentally extend 
prescribed anesthesia and/or other medication administration. Though no definitive cumulative 
or long-term effects of general anesthesia are known with certainty, 25 to mitigate against these 
possible risks the study will not enroll subjects that have history of repeated recent anesthesia, 
and no subject will be allowed to participate more than once in the study. The risks associated 
with general anesthesia during this study are not expected to be significantly higher than those 
that the subject would have otherwise been exposed to had he or she not participated in this 
research. 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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11.2. Adverse Event Definitions 
Adverse Event (AE): As defined by EN ISO 14155-2011: any untoward medical occurrence, 
unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) 
in subjects, users or other persons, whether or not related to the investigational medical device.  
Serious Adverse Event (SAE): As defined by EN ISO 14155 – 2011: an adverse event that  
(a) led to death; 
(b) led to a serious deterioration in the health of the subject, that either resulted in: 
(1) a life-threatening illness or injury, or 
(2) a permanent impairment of a body structure or a body function, or 
(3) in-patient or prolonged hospitalization, or 
(4) medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to body structure or a body function; 
(c) led to fetal distress, fetal death or a congenital abnormality or birth defect. 
Anticipated: Any adverse event and/or reaction, the specificity or severity of which is consistent 
with the EC/IRB approved informed consent, protocol, investigator brochure, or product 
labeling. 
Unanticipated adverse device effect (UADE): As defined by 21 CFR 812.3: means any serious 
adverse effect on health or safety or any life-threatening problem or death caused by, or 
associated with, a device, if that effect, problem, or death was not previously identified in 
nature, severity, or degree of incidence in the investigational plan or application (including a 
supplementary plan or application), or any other unanticipated serious problem associated with 
a device that relates to the rights, safety, or welfare of subjects. 
11.3. Management of Adverse Event Reporting 
Any adverse events will be recorded in the subjects study record and the Adverse Event Case 
Report Form. The following information should be obtained: 
▪ 
Description of Event 
▪ 
Date of onset and resolution  
▪ 
Intensity (mild, moderate, severe) 
- Mild: Symptom(s) barely noticeable to the subject or does not make the subject 
uncomfortable. The AE does not influence performance or functioning. Prescription 
drugs are not ordinarily needed for relief of symptom(s). 
- Moderate: Symptom(s) of a sufficient severity to make the subject uncomfortable. 
Performance of daily activities is influenced. Treatment of symptom(s) may be needed. 
- Severe: Symptom(s) of a sufficient severity to cause the subject severe discomfort. 
Treatment for symptom(s) may be given. 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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▪ 
Serious (yes/no)  
▪ 
Relationship to device (unrelated, possibly related, probably related) 
- Unrelated: The adverse event is reasonably expected to be related to (or caused by) a 
concurrent illness, effect of another device/drug or other cause, and is unlikely related 
to the investigational product 
- Possibly related: The adverse event is reasonably expected to be related to the 
investigational product, and an alternative etiology is equally or less likely compared to 
the potential relationship to investigational product 
- Probably related: There is a strong relationship to investigational product, or recurs on 
re-challenge, and another etiology is unlikely, or there is no other reasonable medical 
explanation for the event. 
▪ 
Treatment given and/or action taken (procedure stopped, withdrawn from study, no action) 
▪ 
Anticipated (yes/no) 
Adverse events will be reported to the local EC/IRB per their policy. 
11.4. Management of Serious Adverse Event and Unanticipated Adverse Device 
Effect Reporting 
All SAEs and or UADEs will be documented as above and reported in writing to the Sponsor 
within 72 hours of knowledge of the event   The Investigator shall submit the Adverse Event 
Case Report Form and GEHC_GQP_10.07.005_F002 Site Notification and Assessment of Serious 
and Unexpected Adverse Events (DOC0910335) with redacted supporting documentation to SAE 
mailbox. If the event resulted in the death of a subject, the event shall also be reported via 
telephone to the Sponsor within 24 hours of knowledge of the event. SAEs will be reported to 
the local EC/IRB per their policy.  
The Sponsor’s Medical Monitor (complete contact information listed in the Study Synopsis) 
should be contacted for SAEs and/or UADEs: 
Fax: 800-888-3983 
E-mail: SAE@ge.com 
If additional information (i.e. outcome of event, date event resolved, additional treatments) is 
required to submit a follow-up report, the Investigator shall update the AE CRF and resubmit to 
Clinical Affairs. The Investigator shall submit the follow-up SAE and/or UADE report to the local 
EC/IRB per their policy.  
11.5. Management of Device Complaints 
Any complaints regarding the operation of the device or software or any malfunctions are to be 
reported to the Research Manager.   
Sponsor contact for device complaints: 
Stephanie Karwedsky, Clinical Affairs Project Manager 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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Telephone: +1 262 443 7008 
E-mail: Stephanie.Karwedsky@ge.com  
 
12. 
EARLY TERMINATION OR SUSPENSION 
12.1. Criteria for Early Termination or Suspension 
The study may be terminated early if the Sponsor determines that unanticipated adverse 
event(s) presents an unreasonable risk to subjects or for any other reason as Sponsor 
determines to be appropriate.  
Termination shall occur no later than 5 working days after the sponsor makes the determination 
and no later than 15 working days after Sponsor first received notice of the effect. 
The Sponsor will promptly notify the Investigators of any determination to terminate the study 
outside of the protocol timeframe. The Sponsor will provide each Investigator with written 
guidelines/instructions on termination processes and timelines.  
The Investigator is responsible for reporting the early termination to their local EC/IRB.  
12.2. Withdrawal of EC/IRB Approval 
The Investigator is to notify the Sponsor of any withdrawal of EC/IRB approval within 5 working 
days of such occurrence. If the EC/IRB terminates or suspends its approval of the Study, the 
Investigator will promptly notify Sponsor and provide a detailed written explanation of the 
termination or suspension. Upon receipt, the sponsor will provide written 
guidelines/instructions on subject withdrawal/termination processes and timelines. 
13. 
ETHICS COMMITTEE (EC) AND REGULATORY FILINGS 
13.1. Regulatory Authority Approval Requirements (Global) 
There are no applicable global regulatory authority approval requirements; however, this study 
will be conducted in accordance with ISO 81060-2:2013 standard requirements. 
13.2. Ethics Committee Approval Requirements 
This study is to be submitted to the EC/IRB for review and approval prior to enrolling subjects. 
The Investigator is responsible for keeping approval current and maintaining appropriate 
correspondence and reports. The study will be conducted in accordance with EC or IRB policy. 
Copies of all EC/IRB applications, approval letters, Informed Consent Forms (ICF) and other 
correspondence are to be sent to the Sponsor, with originals kept in the Site Study Regulatory 
Binder. 
13.3. Management of Protocol Revisions/Amendments  
Any protocol revisions or amendments will be reviewed by the EC or IRB at the investigational 
site and approved by the Sponsor.   

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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13.4. Informed Consent and Privacy Requirements 
Informed consent will be obtained from all subjects prior to participation in the study, per the 
determination of the EC/IRB. 
Institutional and national policies for informed consent and assent for minor patients will be 
followed throughout this study. 
Informed consent will be documented in the source record of each subject. The Investigator or 
designee will consent the subject per regulatory guidelines which include that the subject has 
ample time to review the ICF and have all questions answered to their satisfaction; the subject 
may take the ICF home to review with family members or others prior to agreeing to participate 
in the study; upon agreeing to participate in the study, the subject signs and dates the 
document, and the person who consented the subject signs and dates the document.   
Minor subjects are legally unable to provide informed consent. Therefore these study 
participants are dependent on their parent(s) or legal guardian to assume responsibility for their 
participation in clinical studies. Fully informed consent will be obtained from the legal guardian 
in accordance with applicable laws and regulations. All participants will be informed to the 
fullest extent possible about the study in language and terms they are able to understand. 
Where appropriate, minor subjects will provide assent to enroll in a study (age of assent may be 
determined by IRB/EC or be consistent with local legal requirements). Participants of 
appropriate intellectual maturity should personally sign and date either a separately designed, 
written assent form, or the written informed consent. In all cases, participants should be made 
aware of their rights to decline to participate or to withdraw from the study at any time. 
Attention will be paid to signs of undue distress in patients who are unable to clearly articulate 
their distress, and a minor participant’s wish to withdraw from a study will be respected unless 
special circumstances would, in the opinion of the investigator and parent(s) or legal guardian, 
negatively impact the welfare of a pediatric patient. In such a situation, continued parental or 
legal guardian consent should be sufficient to allow participation in the study. Emancipated or 
mature minors (defined by local laws) may be capable of giving autonomous consent. 
The subject and/or, as applicable, their legally authorized representative, will be given a copy of 
the signed informed consent form and the original will be retained with study files.   
14. 
DATA AND QUALITY MANAGEMENT 
14.1. Management of Data 
Both non-invasive and invasive blood pressure data will be collected from subjects enrolled in 
this study and labeled with de-identified subject identification designation (SID) that will not 
contain any identifiable personal information. 
GE Healthcare may use patient data for future technology development, marketing purposes, 
publications or any other possible use. Specifically, the data obtained in this study may be used 
as part of a regulatory submission. 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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The approved Data Management Plan (DMP) will be located in the study’s clinical history file 
maintained by the sponsor. 
14.2. Subject De-identification 
All subject data will be de-identified (coded) by the investigational site, and subjects will be 
assigned a unique identification number in the format provided by the Sponsor. 
14.3. Completion of Case Report Forms (CRFs) 
Data will be collected using paper CRFs and data collection system (DCS) data per the details of 
this protocol. 
To ensure the quality and integrity of the data, it is the responsibility of the Principal 
Investigator or designee, in a timely manner, to complete a CRF for each subject who is enrolled 
to participate in this study. GEHC will provide CRFs and the instructions for their use. CRFs will 
be completed as information becomes available. 
If errors or omissions are found in the course of a CRF audit or data review, a Data Clarification 
Form (DCF) will be generated and the error, omissions or clarifications will be corrected on these 
forms. 
The Principal Investigator or a Sub-Investigator will sign and date the indicated places on the 
CRF. This signature will indicate that a thorough inspection of the data has been made and will 
thereby certify the contents of the form. 
14.4. Record Retention at the Site 
All records pertaining to the conduct of the study, including Case Report Forms, Informed 
Consent Forms, Ethics Committee (EC) or Institutional Review Board (IRB) correspondence, and 
other study documentation must be retained at the Site for inspection at any time by the GEHC 
Study Monitor or designee. These records will be maintained for a minimum of 5 years and 
thereafter will be handled according to GEHC Retention Policies. Elements should include the 
following: 
▪ 
Subject Files – containing the completed patient CRFs    
▪ 
Regulatory Binder – containing the protocol and amendments, EC/IRB submissions and 
approvals, (blank and signed/dated) Informed Consent Form(s), and Site study logs 
▪ 
Reference Manuals – containing, as applicable, the following documents: resource list, 
responsibilities of the Investigator, Sponsor, adverse event and informed consent guidelines, 
study aids (training material, device screen shots), relevant central supplier instructions, and 
other pertinent documents. 
No records will be destroyed without GE Healthcare notification and approval. 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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15. 
MONITORING PLAN 
15.1. Brief Description 
In collaboration with the site, the sponsor will ensure proper monitoring of the study to confirm 
that all the clinical requirements are met. Monitoring visits will ensure adherence to the 
protocol, completion of informed consents, IRB review of the study, maintenance of records, 
primary outcomes review and review of the CRFs and source documentation for accuracy and 
completeness.   
15.2. Reference to Approved Monitoring Plan 
The approved monitoring plan will be located in the study’s clinical history file maintained by 
the sponsor. 
16. 
PUBLICATION POLICY 
All proposed publications using study data, in full or in part, will be subject to approval by the 
Sponsor prior to submission. The Investigator and Sponsor agree to act in good faith to consider 
the interests of each party in publication. 
17. 
ADDITIONAL STUDY MATERIALS / ADDITIONAL COUNTRY-SPECIFIC 
REGULATORY REQUIREMENTS 
The study will be conducted in accordance with all requirements of ISO 81060-2:2013. This study 
will be conducted in compliance with Good Clinical Practice, per international standards.  
 
 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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REFERENCES 
1. Araghi A, Bander J, Guzman J. Arterial blood pressure monitoring in overweight critically ill patients: invasive or 
noninvasive? Crit Care. 2006;10(2):PMC1550873. 
2. de Greeff A, Lorde I, Wilton A, Seed P, Coleman A, Shennan A. Calibration accuracy of hospital-based non-invasive blood 
pressure measuring devices. J Hum Hypertens. Jan 2010;24(1):58-63. 
3. Maestri R, Pinna G, Robbi E, Capomolla S, La Rovere M. Noninvasive measurement of blood pressure variability: accuracy 
of the Finometer monitor and comparison with the Finapres device. Physiol Meas. Dec 2005;26(6):1125-36. 
4. Gravenstein J, Paulus D. Invasive Blood Pressure Monitoring. Clinical Monitoring in Practice. Philadelphia: JB Lippincott; 
1987. 
5. Barrington K. Umbilical artery catheters in the newborn: effects of catheter design (end vs. side hole). Cohrane Neonatal 
Review. 2009;1. 
6. McDonald D. Blood Pressure FLow in Arteries. London: Edward Arnold; 1974. 
7. Baker P, Westenskow D, Kück K. Theoretical analysis of non-invasive oscillometric maximum amplitude algorithm for 
estimating mean blood pressure. Med Biol Eng Comput. 1997;35(2):271-8. 
8. Schima H BH, Huber L, Schmallegger H, et al. Automatic system for noninvasive blood pressure determination in rotary 
pump recipients. Artif Organs. 2004;28(5):451-7. 
9. Onodera J, Kotake Y, Fukuda M, et al. Validation of inflationary non-invasive blood pressure monitoring in adult surgical 
patients. J Anesth. 2011;25(1):127-30. 
10. Ramsey M. Noninvasive automated determination of mean arterial pressure. Medical and Biological Engineering and 
Computing. 1979;17:11-18. 
11. American National Standards Institute, Inc. 5ANSI/AAMI SP10, Manual, Electronic, or Automated Sphygmomanometers. 
Arlington, VA: Association for the Advancement of Medical Instrumentation; 2002, 2008. 
12. Friedman D. GE DINAMAP SuperSTAT: Setting Target Inflation Pressure. GE Healthcare. 2013. Available at: 
http://www3.gehealthcare.co.uk/~/media/Downloads/uk/Product/Intensive%20Care/Brochure%20-
%20DINAMAP%20SuperSTAT%20Algorithm.pdf?Parent=%7B0E27EAC2-EEA0-4592-AC38-FDBD538CCDA3%7D. 
13. Qiao H, Zhang J, Liang W. Validity of pulse pressure and systolic blood pressure variation data obtained from a Datex 
Ohmeda S/5 monitor for predicting fluid responsiveness during surgery. J Neurosurg Anesthesiol. 2010;22(4):316-22. 
14. Hegde H, Mudaraddi R, Yaliwal V, Rao P. Comparison of oscillometric blood pressure measurement by two clinical 
monitors: Datex Ohmeda GE S/5 and Criticare 8100E nGenuity. Indian J Anaesth. 2011;55(2):199-200. 
15. Sabourdin N, Louvet N, Constant I. Selection of Anesthesia Techniques for the Neonate. In: Lerman J, ed. Neonatal 
Anesthesia. New York, NY: Springer; 2014. 
16. Department of Anesthesia. Pediatric Anesthesia: Patient Safety. Stanford, CA 2015. 
17. Braz L, Braz D, Santos da Cruz D, Fernandes L, Modolo N, Braz J. Mortality Review in Anesthersia: A systematic review. 
Clinics (São Paulo, Brazil). 2009;64(10):999-1006. 
18. Gonzalez L, Pignaton W, Kusano P, Módolo N, Braz J, Braz L. Anesthesia-related mortality in pediatric patients: a 
systematic review. Clinics (Sao Paulo). 2012;67(4):381-7. 
19. Hansen TG. Anesthesia-related neurotoxicity and the developing animal brain is not a significant problem in children. 
Pediatric Anesthesia. 2014:65-72. 
20. Rizzi S, Ori C, Jevtovic-Todorovic V. Timing versus duration: Determinants of anesthesia-induced developmental 
apoptosis in the young mammalian brain. Ann NY Acad Sci. 2010:43-51. 
21. Zhu Cea. Isoflurane anesthesia induced persistant, progressive memory impairment, caused a loss of neural stem cells, 
and reduced neurogenesis in young, but not adult, rodents. Journal of Cerebral Blood Flow and Metabolism. 2010:1017-
1030. 
22. Chiao S, Zuo Z. A Double-Edged Sword: Volatile Anesthetic Effects on the Neonatal Brain. Brain Sciences. 2014:273-294. 
23. Loftis G, Collins S, McDowell M. Anesthesia-Induced Neuronal Apoptosis During Synaptogenesis. AANA J. 
2012;80(4):291-98. 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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24. Jevtovic-Todorovic V, Hartman R, Izumi Y. Early exposure to common anesthetic agents causes widespread 
neurodegeneration in the developing rat brain and persistent learning deficits. Neurosci. 2003;23(3):876-882. 
25. Flick RPea. Cognitive and Behavioral Outcomes After Early Exposure to Anesthesia and Surgery. Pediatrics. 2011:1053-
1061. 
26. Kalkman G, Peelen L, Moons K. Behavior and development in children and age at the time of first anesthetic exposure. 
Anesthesiology. 2009;110:805-812. 
27. GE Healthcare. Dash 4000. GE Healthcare: Products. November 11, 2011. Available at: 
http://www3.gehealthcare.com/en/Products/Categories/Patient_Monitoring/Patient_Monitors/Dash_4000#tabs/tab27
A1ED7BA21846C18A923C35AD58FC6D. Accessed September 19, 2013. 
28. Friedman B, Hersh L, Kolluri S, Medero R. Artifact rejection using pulse quality values: US Patent; 2006. US 7070566 B2. 
29. Friedman B, Hersh T, Medero R. Calculation of quality and its use in determination of indirect noninvasive blood 
pressure: US Patent. US 6358213 B1. 
30. Hersh L, Kolluri S, Medero R. Oscillometric determination of blood pressure: US Patent; 2005. US 7311669 B2. 
31. GE Healthcare. B40 Monitor: Simple. Compact. Reliable. 2012. 
32. Hedge H, Mudaraddi R, Yaliwal V, Rao P. Comparison of oscillometric blood pressure measurement by two clinical 
monitors: Datex Ohmeda GE S/5 and Criticare 8100E nGenuity. Indian J Anaesth. 2011;55(2):199–200. 
33. GE Healthcare. CARESCAPE Monitor B650. Milwaukee, WI 2013. 
34. GE Healthcare. GE Healthcare Announces FDA Clearance of CARESCAPE Monitor B650 Patient Monitor. GE Imagination 
at Work. November 3, 2010. Available at: 
http://www.genewscenter.com/content/Detail.aspx?ReleaseID=11263&NewsAreaID=2. Accessed September 19, 2013. 
 
 
 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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APPENDIX A: AMENDMENT TO PROTOCOL VERSION 1.0  
Purpose: This amendment document clarifies the inclusion criteria and minor issues 
(clarification related) in the procedure sections. 
The following amendments were made to version 1.0 to produce version 2.0. Point-by-point 
revisions are shown as additions in double-underline (double-underline) and deletions in 
strikethrough (strikethrough) for each change made in this amendment for the previous version. 
Item 
Section 
Revision or Clarification 
Justification 
1 
Table 3 
Updated Neonate III Weight to “≥ 2000g” 
Consistent with ISO 
81060-2:2013. 
2 
Section 6.4. Inclusion 
Criteria 
5. 
Require non-emergent heart catheterization (all subjects 
except neonates);; 
6. 
NeonatesFor neonates only –, require non-emergent heart 
catheterization using the umbilical arterial lines that have 
been placed for route care.line as access; 
 
Clarified criteria for 
inclusion for neonates 
to ensure safety. 
3 
Section 7.1.1. Baseline 
Examination (all sites) 
(BS EN 1060-4:2004) 
1. 
Demographics (AgeandDate of Birth and Gender) 
 
Added requirement for 
collection of date of 
birth as evidence of 
age. 
4 
Section 7.1.3. Patient 
Procedure and 
Procedure-Specific 
Assessments (all sites) 
Evaluation of the tested devices will be conducted during each 
patient’s prescribed catheterization procedure by two trained 
observers and a supervisor. For each patient, the following 
procedure-specific information will be recorded on CRFs: 
 
Clarified parties 
performing 
catheterization and 
evaluation. 
5 
Section 7.1.4. Static 
Calibration of the IBP 
System: Blood Pressure 
Assessments 
2. 
Remove the cuffexisting cuffs from the patient. 
 
Clarified that the 
referenced cuff is the 
existing cuff. 
 
 
 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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APPENDIX B: AMENDMENT TO PROTOCOL VERSION 2.0  
Purpose: This amendment document describes in detail the changes made to the study protocol 
to allow to make procedural clarifications and to add additional safeguards for neonate 
populations beyond the scope of the original procedure for neonate subjects. Additionally, it 
removes the requirement to adhere to all data collection elements of BS EN 106004:2004, due 
to incompatibility of aspects of this standard with ISO 81060-2-2013. 
The following amendments were made to version 2.0 to produce version 3.0. Point-by-point 
revisions are shown as additions in double-underline (double-underline) and deletions in 
strikethrough (strikethrough) for each change made in this amendment for the previous version. 
Item 
Section 
Revision or Clarification 
Justification 
6 
Investigator Signature 
page 
have read this protocol and study related documents and agree to 
conduct this study in full accordance with the stipulations of the 
protocol described herein, and any subsequent amendments.  
 
I hereby agree to: 
(i)   Conduct the investigation in accordance with the agreement, the 
investigational plan, FDA or applicable government regulations, 
and conditions of approval imposed by the reviewing Ethics 
Committee, IRB or governing regulatory body; 
(ii)  Supervise all testing of the device involving human subjects; and 
(iii) Ensure that the requirements for obtaining informed consent are 
met. 
 
Updated per Sponsor’s 
internal procedures. 
 
Abbreviations 
AAMI  
 
Association for Advancement of Medical 
Instrumentation  
BP 
 
BP 
DCS 
 
Data collection system 
ECG 
 
Electrocardiogram 
LCS 
 
Life Care Solutions  
IABP 
 
Intra-arterial blood pressure 
IBP 
 
Invasive blood pressure 
ISO 
 
International Standards Organization 
MAA 
 
Maximum amplitude algorithm 
MAP 
 
Mean blood pressure 
NIBP 
 
Noninvasive blood pressure 
PAD 
 
Peripheral Artery Disease 
PDM 
 
Patient Data Module (for CARESCAPE B650) 
PSM 
 
Patient Side Module (for CARESCAPE B650) 
Psys 
 
Systolic pressure 
Pt  
 
Target pressure 
 
 
7 
Study Synopsis: Brief 
Description of Study 
Purpose 
This study is required to demonstrate that the non-invasive blood 
pressure (NIBP) measurement algorithms on two commercially 
available multifunction hemodynamic acquisition modules, the Patient 
Data Module (PDM) equipped with the DINAMAP® SUPERSTAT 
algorithm (“PDM-SUPERSTAT”) and the Patient Side Module (PSM) 
equipped with Datex-Ohmeda GE algorithm (“PSM-Datex-Ohmeda”), 
provide accurate NIBP measurements in accordance with the 
guidelines provided by the  most recent International Organization for 
Standardization (ISO) 81060-2:2013 requirements relevant to Unites 
Removed the requirement 
to adhere to all data 
collection elements of BS 
EN 106004:2004, due to 
incompatibility of aspects 
of this standard with ISO 
81060-2-2013. 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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Item 
Section 
Revision or Clarification 
Justification 
States devices and the BS EN 1060-4:2004 standard widely recognized 
in Europe. 
8 
Study Synopsis: 
Investigator Names  
Investigator Names:  
David Scott Marks, MD MBA  
Professor and Vice Chair of 
Medicine and Radiology  
Director of Cardiac 
Catheterization Laboratories 
and Clinical Trials 
Froedtert Hospital/Medical 
College of Wisconsin 
 
Jeffrey Garland, MD 
Director of Perinatal 
Research 
Wheaton Franciscan 
Healthcare – St. 
Joseph’sSusan Foerster, MD 
Pediatric Cardiologist 
Assistant Professor, Medical 
College 
Member, Children's 
Specialty Group 
Children’s Hospital of 
Wisconsin  
Address:  
    
9200 West Wisconsin 
Avenue 
Milwaukee, WI 53226 
Telephone:  414-805-0579  
E-mail: dmarks@mcw.edu 
 
 
Address:      5000 West 
Chambers Street 
Milwaukee, WI 53210 
9000 West Wisconsin 
Avenue 
Milwaukee, WI 53226 
Telephone:   
414- 447-2663 
414-266-2884  
E-mail: 
jsgarland@hotmail.com 
SFoerster@chw.org  
 
 
Updated site and 
investigator information. 
9 
Study Synopsis: 
Device/Product 
Description 
(DSCDCS) for storage and analysis purposes 
 
Typographical correction. 
10 
Study Synopsis: Regulatory 
Status 
Pre-Market 
 The commercial DASH® 4000 patient 
monitor (control system) equipped with GXP 
validated non-commercial DC-COLLECTOR 
and DC-Edit software programs for data 
collection is considered investigational. The 
acquisition modules PDM-SuperSTAT and 
PSM-Datex-Ohmeda  with the above 
identifiedPSM-Datex-Ohmeda and PDM-
SuperSTAT algorithms and used on the 
CARESCAPE Monitor B650 and accessories 
are commercially available. Though pre and 
post market devices are utilized, all aspects 
of the study will be considered 
investigational.The commercial DASH® 4000 
patient monitor (control system) equipped 
with GXP validated non-commercial DC-
COLLECTOR and DC-Edit software programs 
for data collection is considered 
investigational 
Post-Market 
 Devices under study (Acquisition 
modules PDM-SuperSTAT and PSM-Datex-
Ohmeda used on the CARESCAPE Monitor 
B650) are currently commercial devices in 
the US 
Updated the study 
regulatory status to more 
clearly indicate the 
investigational devices. 
This is a clarification to 
original intent. 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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11 
Study Synopsis: Medical 
Monitor Name 
 
Medical Monitor Name: 
Ron Von Jako, MDOlli 
Vaisanen, MD 
Address:        
301 Ballardvale St., 
Suite 4 
Wilmington, MA 01887-
4405Kuortaneenkatu 2 
00510 FI 
Telephone: +1 781 262 
5579+358 40 652 9662 
E-mail:          
Ron.VonJako@med.ge.com Oll
i.Vaisanen@ge.com 
 
 
Updated Medical Director 
name and contact 
information. 
12 
Section 2.1. Literature 
Review 
The basis of this standard if is… 
BS EN 1060-4:2004 
The BS EN 1060-4:2004 standard for determining the overall system 
accuracy of non-invasive sphygmomanometers is a similar British-
adopted standard required by many regulatory bodies in the United 
Kingdom and worldwide. The BS EN 1060-4:2004 standard was 
developed under a mandate given the European Committee for 
Standardization (CEN) by the European Commission and the European 
Free Trade Association to provide a means of conforming to the 
Essentials Requirements of the New Approach Directive 93/42/EC 
Medical Devices. 4 In many areas in Europe, satisfaction of the BS EN 
1060-4:2004 is requisite to determining the clinical suitability of NIBP 
devices for use in routine clinical practices. Furthermore, satisfaction 
of this standard may also be a first step to achieving ‘Grade A’ rating 
according to the British Hypertension Society (BHS) in the United 
Kingdom. 5 Thus, it is critical that devices used in both America and 
Europe comply with both ISO 81060-2:2013 and BS EN 1060-4:2004 
guidelines. 
 
Typographical correction. 
 
Removed background 
relating to the 
requirement to adhere to 
all data collection 
elements of BS EN 
106004:2004, due to 
incompatibility of aspects 
of this standard with ISO 
81060-2-2013. 
13 
Section 2.3. Device Risk 
Analysis 
Participation in this study has no direct benefit to participants; 
however, participants may benefit from more reliable assessment of 
blood pressure readings during their procedure due to the use of 
multiple devices and multiple recordings for blood pressure 
measurement. Participation in this study will not alter the prescribed 
cardiac catheterization procedure recommended by the patient’s 
physician, though the duration of the procedure may be slightly 
increased by a period of time not expected to exceed 20 minutes (1-2 
minutes per NIBP measurement). For neonatal patients, risk will be 
minimized by the inclusion of neonate patients that are being 
catheterized using routine umbilical line catheterization, which has 
been shown to have a minimal complication rate even during longer 
procedures when performed by experienced physicians. 7 Neonatal 
patients may participate for up to three days, taking aas few 
determinations as necessary to accomplish research objectives each 
day at theunder the supervision of a medically qualified investigator 
discretion. 
 
Clarified neonatal risk 
statement. 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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14 
Section 4.1. Hypothesis 
This is a study conducted to satisfy both the ISO 81060-2:2013 and BS 
EN 1060-4:2004 standards for two NIBP devices (PSM-Datex-Ohmeda 
and PDM-SuperSTAT) and, as such, does not require a statistical 
hypothesis. The Pass/Fail criteria for this study are set forth in Section 
9.5 - Pass/Fail Criteria of the Study. 
 
Removed the requirement 
to adhere to all data 
collection elements of BS 
EN 106004:2004, due to 
incompatibility of aspects 
of this standard with ISO 
81060-2-2013. 
15 
Section 4.2.1. Primary 
Objective: 
The primary objective of the study is to determine if the PSM-Datex-
Ohmeda and PDM-SuperSTAT NIBP measurement devices provide 
accurate blood pressure measurements in all indicated patient 
populations (neonates, children, pediatrics, adolescents and adults, 
and special populations) according to the definitions set forth by ISO 
81060-2:2013 and BS EN 1060-4:2004 . 
 
Removed the requirement 
to adhere to all data 
collection elements of BS 
EN 106004:2004, due to 
incompatibility of aspects 
of this standard with ISO 
81060-2-2013. 
16 
Section 4.3.1. Primary 
endpoints: 
For NIBP only: 
• 
Accuracy, determined according to ISO 81060-2:2013 
and BS EN 1060-4:2004 
 
Removed the requirement 
to adhere to all data 
collection elements of BS 
EN 106004:2004, due to 
incompatibility of aspects 
of this standard with ISO 
81060-2-2013. Corrected 
typographical error. 
17 
Section 6.1.1. Number of 
Subjects 
The total minimum enrollment for both algorithm arms is 100 83 
total evaluable patients. Non-evaluable patients, as determined by 
the Sponsor per the ISO 81060-2:2013 and BS EN 1060-4:2004 
standards, will not be counted towards the minimum quota 
requirements. Enrollment will continue until the minimum 
evaluable patient enrollment are met and the patient distribution 
requirements of the both ISO 81060-2:2013 and BS EN 1060-4:2004 
standards are met. Total patient enrollment in both arms will not 
exceed 140 200 patients. 
The two NIBP measurement arms in this study are:  
1. 
PDM-SuperSTAT Arm (minimum of 55 45 evaluable 
patients): GE DINAMAP® SuperSTAT algorithm delivered 
by the PDM acquisition module connected to the 
CARESCAPE Monitor B650 
2. 
PSM-Datex-Ohmeda Arm (minimum of 45 38 evaluable 
patients): Datex-Ohmeda  delivered by the PSM 
acquisition module connected to the CARESCAPE Monitor 
B650 
 
Adjusted number of 
subjects to reflect 
necessary population to 
satisfy the ISO 81060-2-
2013 requirement. 
18 
Section 6.1.2. Summary of 
Patient Stratification 
Requirements 
PDM-SuperSTAT Arm 
Minimum of 55 45 evaluable subjects, including: 
• 
≥20 15 adults and adolescents >12 years old 
▪ 
15 adults ≥50 years old  
▪ 
5 adults ≥18 to <50 years old 
• 
≥5 adolescents (≥12 to <18 years old) 
• 
≥5 pediatric (≥3 to ≤<12 years old), 
• 
≥7 Atrial Fibrillation Patients  (≥18 years old) 
▪ 
4 adults ≥50 years old 
▪ 
3 adults ≥18 to <50 years old  
Adjusted number of 
subjects to reflect 
necessary population to 
satisfy the ISO 81060-2-
2013 requirement. 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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• 
≥18 neonates(≤28 days) and infants/children 
(≥29 days to <3 years old) 
• 
≥18 neonates/infants (≥29 days <3 years old) 
WeThis study intends  intend to collect 10 paired measurements (NIBP 
and IBP) per patient, and will collect a minimum of: 
• 
≥370 270 valid blood pressure measurement pairs 
should be obtained for patients ≥3 years old 
• 
≥180 150 valid blood pressure measurement pairs 
should be obtained for patients <3 years old 
 
PSM-Datex-Ohmeda Arm 
Minimum of 45 38 evaluable subjects, including: 
• 
≥15 adults and adolescents >12 years old 
▪ 
15 adults ≥50 years old  
▪ 
5 adults ≥18 to <50 years old 
• 
≥5 adolescents (≥12 to <18 years old) 
• 
≥5 pediatric (≥3 to ≤<12 years old), 
• 
≥ 15 18 neonates/infants/children (<3 years old and 
weighing >5 kg)  
This study intends We intend to collect 10 paired measurements (NIBP 
and IBP) per patient, and will collect a minimum of: 
• 
≥300 200 valid blood pressure measurement pairs 
should be obtained for patients ≥3 years old 
• 
≥150 valid blood pressure measurement pairs 
should be obtained for patients <3 years old 
weighing >5 kg (approximately 11 lbs) 
 
19 
Section 6.3.1. Enrollment 
Strategy for Stratification 
Groups 
Patients will be consecutively enrolled until each stratification quota 
reaches its minimum quota for enrollment per study arm. When the 
minimum number of patients is enrolled, enrollment will end on a per-
strata basis. When all strata have reached their minimum enrollment 
targets, additional patients may be consecutively enrolled that meet 
any stratification criteria in order to reach the target total patient 
enrollment number described in Section 6.1 – Number of Subjects, and 
to meet the patient distribution requirement set forth in the ISO 
81060-2:2013 and BS EN 1060-4:2004 standards. 
 
Removed BS EN 
106004:2004 
requirements. 
20 
Section 6.3.2 Minimum 
Patient Numbers and Cuff 
Sizes 
Requirements of the BS EN 1060-4:2004 Standard 
There are no specific cuff size requirements for the BS EN 1060-4:2004 
standard. The patient numbers are in accordance with the percentage 
values required by both standards. 
 
Removed BS EN 
106004:2004 
requirements. 
21 
Section 6.3.3. Stratification 
of Adult Patients  
6.3.3 Stratification of Adult Patients (Adult Site) 
Enrollment of adult patients andwill be the same in both study arms 
(PSM-Datex-Ohmeda and PDM-SuperSTAT) except that additional 
special population patients (chronic atrial fibrillation patients) will be 
stratifiedincluded in the PDM-SuperSTAT stratification groups by age 
and gender (, as shown in Table 1) . 
 [Updated Table 1] 
Removed BS EN 
106004:2004 
requirements and 
outdated site names. 
22 
Section 6.3.4. Stratification 
of Pedeatrics 
6.3.4 Stratification of Pediatric, Children, Infant, and Neonatal 
Patients (Children’ss Site) 
Removed BS EN 
106004:2004 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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The enrollment of pediatric patients (aged ≥3 AND ≤12 years) will be 
the same in both study arms (PSM-Datex-Ohmeda and PDM-
SuperSTAT), as described in Table 2.  
The enrollment of adolescent and pediatric patients will be the same 
in both study arms (PSM-Datex-Ohmeda and PDM-SuperSTAT), as 
described in Table 2. 
Enrollment of adolescent (aged ≥12 and ≤18 years) and pediatric (aged 
≥3 AND <12 years) will be stratified by age and gender (Table 2). 
Table 2 –  Adolescent and Pediatric Enrollment Stratification by Age 
and Gender 
[Revised Table 2] 
Abbreviations: M = male; F = female; n, number of patients 
Note: # 30% of population to be male and 30% of population to be 
female 
 
requirements and 
outdated site names. 
23 
Section 6.3.5. Stratification 
of Children, Infant, and 
Neonatal Patients 
6.3.5. 
Stratification of Children, Infant, and Neonatal Patients 
The enrollment of children < 3 years of age will be the different in each 
study arm (PDM-SuperSTAT and PSM-Datex-Ohmeda), as described in 
Tables 3 and 4, respectively. There will be no stratification by gender. 
The  neonates will not be evaluated by the PSM-Datex-Ohmeda 
module.The enrollment of adolescent and pediatric patients will be 
the different in each study arm (PDM-SuperSTAT and PSM-Datex-
Ohmeda), as described in Tables 3 and 4, respectively. 
[Revised Tables 3 and 4] 
 
Removed BS EN 
106004:2004 
requirements and 
outdated site names. 
24 
Section 6.3.6. Additional 
Requirements: 
Additional requirements on for patient distribution required by ISO 
81060-2:2013 and/or BS EN 1060-4:2004  are listed below: 
Age >50 years (BS EN 1060-4:2004)                    
Among adult, adolescent and children over 3 years old, 50%-75% shall 
be older than 50 years. For PDM-SuperSTAT, at least 19 patients 
should be older than 50; and for PSM-Datex-Ohmeda, at least 15 
patients should be older than 50.  
Limb Size Distribution (ISO 81060-2:2013) 
           Among adult, adolescent and children over 3 years 
old, a minimum of 10% patients will be examined 
using each of the 5 cuff sizes for children and adults. 
For PDM-SuperSTAT, at least 4 3 patients for each 
cuff; and for PSM-Datex-Ohmeda, at least 3 2 
patients for each cuff. 
Blood Pressure Distribution (ISO 81060-2:2013) 
          Among adult and adolescent patients, at least 10% 
patients will be in each of the following four BP 
groups: 
• 
10% systolic BP ≤100 mmHg 
• 
10% systolic BP ≥160 mmHg 
• 
10% diastolic BP ≤ 70 mmHg 
• 
10% diastolic BP ≥ 85 mmHg 
• 
systolic BP ≤100 mmHg, 
• 
systolic BP ≥160 mmHg, 
• 
diastolic BP ≤ 70 mmHg, and 
• 
diastolic BP ≥  85 mmHg. 
Note: Neonates, infants, and children between 3less than 
and 12 years old are exempt from this requirement. The 
Removed BS EN 
106004:2004 
requirements. 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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mean of the reference invasive systolic and diastolic blood 
pressure measurements taken during the study will be used 
in calculation.  
Blood Pressure Distribution (BS EN 1060-4:2004)  
          Among adult, adolescent, and children over 3 years 
old, at least 10% patients will be in each of the 
following four BP groups: 
• 
systolic BP ≤110 mmHg, 
• 
systolic BP ≥160 mmHg, 
• 
diastolic BP ≤ 70 mmHg, and 
• 
diastolic BP ≥  100 mmHg. 
Note: children between 3 and 12 years old are included. The first valid 
reference invasive systolic and diastolic blood pressure measurement 
taken during the study will be used in calculations.  
 
 
 
Modification of Stratification Quotas to Meet Standard 
Requirements 
The specific quotas in this study have been designed by the Sponsor as 
a Good Faith  representation of calculated values for patient and 
procedure numbers provided in the ISO 81060-2:2013 and BS EN 
1060-4:2004 standards. Due to the complexity of these standards, 
unexpected changes in patient enrollment, accrual of evaluable data 
pairs (NIBP and IBP), and device type may require modification to the 
stratification quota during the course of the study. 
If the Sponsor conducts a review during this study that indicates a 
total patient enrollment in any stratification group that meets or 
exceeds the number required to satisfy the ISO 81060-2:2013 and BS 
EN 1060-4:2004 standards, the Sponsor may discontinue or continue 
enrollment in any stratification group. Continuation and 
discontinuation of enrollment in any stratification group will be made 
at the discretion of the Sponsor, and the Investigator will be notified 
by the Sponsor upon such a determination. 
 
25 
Section 6.5. Inclusion 
Criteria 
Subjects will be included that: 
1. 
Require non-emergent heart catheterization, if 
greater than 3 years of age; subjects less than 3 years 
of age will be assessed using indwelling 
radial/femoral/pedal or umbilical arterial monitoring 
lines; 
2. 
Require non-emergent heart catheterization (all 
subjects except neonates); 
3. 
Neonates only – umbilical arterial lines that have 
been placed for route care. 
2. 
Have an upper limb (right OR left side) that fits a cuff 
size of the device (circumference ranging 3 cm to 40 
cm) OR have a thigh (right OR left side) that fits a cuff 
size of the device (circumference ranging 38 to 50 
cm); 
Revised to safeguard 
subjects. 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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3. 
Is Are willing and able to provide blood pressure 
measurements using both IBP and NIBP; 
4. 
Is Are able and willing to provide written informed 
consent or hashave a legally authorized 
representative that is willing to provide written 
informed consent with assent from minor patients, if 
required by IRB policy; 
 
5. 
If informed consent is provided by a legally 
authorized representative on the patient’s behalf, the 
subject is willing to provide assent to study 
participation, if capable of providing assent in the 
opinion of the investigator. 
 
26 
Section 6.6. Exclusion 
Criteria 
Subjects will be excluded that: 
9. 
Do not meet the stratification quota set forth in Tables 
1 and 2; 
1. 
Exhibit signs or symptoms or have a current diagnosis 
of peripheral vascular disease in either upper AND/OR 
lower limbs; 
2. 
Have current, uncontrolled circulatory shock; 
3. 
Exhibit injuries, deformities, intravenous lines, or other 
abnormalities that, in the opinion of the investigator, 
may prevent proper cuff application or functioning; 
4. 
Are currently pregnant, suspect that they are 
pregnant, or are currently lactating; 
5. 
Have contraindications to standard BP measurements; 
6. 
Have any other condition that makes the subject 
unable to tolerate 4 fast flushes (adult, adolescent, or 
pediatric) or 1 fast flush (neonates and children <3 
years of age) for dynamic calibration without posing a 
risk to the patient’s physiological stability. 
7. 
Are under general anesthesia. 
Revised to safeguard 
subjects. 
27 
Section 7.1.1. Baseline 
Examination (all sites) (BS 
EN 1060-4:2004) 
7.1.1 Baseline Examination (all sites) (BS EN 1060-4:2004) 
For enrolled patients that have provided informed consent 
the following baseline information will be collected on CRFs 
after informed consent requirements have been satisfied 
and before the procedures are performed: 
1. 
Demographics (Ageand Gender) 
2. 
Height and Body Weight 
3. 
Relevant Medical History  
4. 
Cardiovascular condition(s) 
5. 
Physiological Condition (Stable/Unstable)  
6. 
Urine pregnancy test, if applicable (females of childbearing 
potential) 
7. 
Arm or Thigh Circumference (cm) 
8. 
Appropriate Cuff Brand (Critikon® Soft-Cuf or Classic-Cuf) 
and Size 
Removed BS EN 
106004:2004 
requirements 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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9. 
Baseline Non-Invasive Blood Pressure (NIBP), consisting of 
systolic blood pressure (SBP) and diastolic blood pressure 
(DBP)   
10. Location of NIBP Measurement (Arm/Thigh) and measuring 
circumstance 
11. Mean Arterial Pressure (MAP) 
12. Current medications 
13. Pulse rate 
 
28 
Section 7.1.2. Required 
Setup Procedures 
7.1.2. 
Required Setup Procedures for all Subject Stratifications (all 
sites) 
Removed for consistency 
with subject stratification 
changes. 
29 
Section 7.1.3 Patient 
Procedure and Procedure-
Specific Assessments 
7.1.3 Patient Procedure and Procedure-Specific Assessments (all 
sites) 
For each patient, the following procedure-specific 
information will be recorded on CRFs: 
1. 
Model and serial number for the DASH® 4000  
2. 
Model and serial number for CARESCAPE B650  
3. 
Model and serial number for the PSM or PDM acquisition 
module used 
4. 
Catheter cross-section, length, and trade name 
5. 
Trade name of pressure transduce 
6. 
Site/artery used for IBP measurements 
7. 
Monitor filter settings and recording settings, if applicable 
8. 
Measuring circumstance (at rest OR during or immediately 
following exercise; if at rest, record whether the patient is 
sitting or lying down) 
9. 
Identification of the observer making the recordings (name 
and position) 
10. Details of any special circumstances during measurement 
11. Pulse rate at the start of device evaluations 
12. Time and date of last manometer calibration 
ECG Placement and Setup 
Three ECG sensors will be placed on patients aged ≥29 days, with leads 
on the left and right arm and left leg connected to the DASH® 4000. No 
ECG will be captured for subjects aged <29 days. 
Three ECG sensors will be placed on the patient, with leads on the left 
and right arm and left leg connected to the DASH® 4000. 
 
Removed for consistency 
with subject stratification 
changes and made 
changes to safeguard 
subjects. 
30 
Section 7.1.4. Arterial 
Catheterization 
Dynamic calibration will be performed in the beginning of each 
procedure according to the “Dynamic Calibration” section of the 
Device Set-Up Manual provided by the Sponsor.  A maximum of 1 flush 
is to be conducted for patients aged <3 years. A maximum of 4 flushes 
may be conducted for patients aged ≥3 years. During calibration, 
values will be recorded for: 
4. 
Number of fast flushes 
5. 
Damping  coefficient 
6. 
Natural frequency 
Dynamic calibration will be performed throughout each procedure as 
IBP records continuously rather than at discreet intervals like NIBP 
Added safeguards for 
subjects. 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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(“Dynamic Calibration” section of the Device Set-Up Manual provided 
by the Sponsor). 
 
31 
Section 7.1.5. Blood 
Pressure Assessments 
NIBP will be measured using the CARESCAPE Monitor B650 patient 
monitor equipped with an acquisition module (either PDM-SuperSTAT 
or PSM-Datex-Ohmeda, determined by study arm). IBP will be 
measured using the DASH® 4000 plus DC-COLLECTOR and DC-EDIT 
software. During the blood pressure assessments, values will be 
recorded for: 
6. 
Treatment Arm 
7. 
Time of first and last blood pressure 
measurement 
8. 
Systolic, Diastolic, Mean, Test Duration 
9. 
If the prescribed wait time was taken 
between tests 
10. Any measurements with no determination 
Table 5 – Number of Blood Pressure Assessments 
Population 
Maximum Number of Blo
Pressure Determination
≥ 3 years old 
15 
< 3 years old to > 29 days old 
15 
‹ 29 days old 
5-10 
 
NIBP will be measured up to 15 times for each patient using the 
CARESCAPE Monitor B650 patient monitor equipped with an 
acquisition module (either PDM-SuperSTAT or PSM-Datex-Ohmeda, 
determined by study arm) to obtain a minimum of 5, maximum of 10 
valid NIBPs per patient. For adults, adolescents and children older than 
3, all valid NIBPs should be taken within 60 minutes; and for neonates, 
infants and children under 3 years, at least 3 valid NIBPs should be 
taken within 60 minutes. IBP will be measured using the DASH® 4000 
plus DC-COLLECTOR and DC-EDIT software. 
Both NIBP and IBP assessments will be conducted simultaneously, with 
IBP data collected on the DCS and NIBP data recorded by hand onto a 
paper Case Report Form (CRF). If necessary, assistance will be 
provided by other study staff to ensure that accurate and 
simultaneous blood pressure data is recorded. 
IBP data will be continuously collected throughout the study and NIBP 
data will be recorded according to the following procedure: 
7. 
Use the patient monitor equipped with either 
PDM-SuperSTAT or PSM-Datex-Ohmeda 
according to the patient’s study arm to determine 
the patient's blood pressure. 
8. 
Remove the cuff from the patient. 
9. 
Clear the patient monitor memory of the previous 
determination and wait at least 3 min  
Note: For the CARESCAPE Monitor B650, the memory can only be 
cleared by discharging the case (with acquisition module 
attached) 
 
10. Have the observers using the reference IBP 
monitoring equipment (DASH® 4000) and the 
Added safeguards for 
subjects. 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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NIBP monitoring equipment (CARESCAPE Monitor 
B650 with either PSM or PDM) simultaneously 
record and determine the patient's blood 
pressure, as follows. 
a. 
Select the appropriate patient monitors based on 
study arm 
b. 
Put on correctly sized cuffs 
c. 
Start continuous collection on the IBP DCS system at 
the same time as recording of NIBP begins 
d. 
Collect each NIBP measurement from the CARESCAPE 
Monitor B650 
e. 
Discharge the patient monitor to clear the memory of 
the previous NIBP determination after each 
determination.  
Note: Because the discharge will erase the data from the 
previous NIBP measurement, record all necessary values 
before discharging the 
11. Wait at least 60 sthe following amount of time 
(Table 6) between determinations or, for 
neonatal patients, 3 min. 
Table 6 – Minimum Time between Determinations 
[Added Table 6] 
Population Age 
Minimum Wait Period 
≥ 3 years 
≥60 seconds 
> 29 days old to 3 
years 
≥60 seconds 
‹ 29 days 
≥3 minutes (variable)* 
 
*Wait period is based on the investigator’s discretion of patient 
health status of the patient. It is, however, suggested that a 20 
minute wait period may be appropriate between 3 
determinations obtained within a 2 hr window OR 4 
determinations obtained within a 3 hr window. 
 
6. 
Repeat steps 4, 5, and 6 until 10 the target number of recordings 
and determinations have been performed. In the event that any 
blood pressure determination is not successful, the procedure 
may be repeated to achieve 10 the target number of successful 
blood pressure determinations. No more than 15 the maximal 
number of total blood pressure determinations as specified 
abovein Table 5 will be performed on any patient. 
Neonates Only: Neonatal patients may participate for up to three 
days, taking an average of 3-4 determinations each day at the 
investigator’s discretion. 
32 
Section 7.3. Withdrawal 
and Discontinuation 
Criteria 
If the Sponsor conducts a review during this study that indicates a 
total patient enrollment in any stratification group that meets or 
exceeds the number required to satisfy the ISO 81060-2:2013 and BS 
EN 1060-4:2004  standardss, the Sponsor may discontinue or continue 
enrollment in any stratification group. Continuation and 
discontinuation of enrollment in any stratification group will be made 
Removed BS EN 
106004:2004 
requirements 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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at the discretion of the Sponsor, and the Investigator will be notified 
by the Sponsor upon such a determination. 
 
33 
Section 9.1.1. Analysis 
Populations 
Separate analysis will be performed for PSM-Datex-Ohmeda and the 
PDM-SuperSTAT arms per requirements of the ISO 81060-2:2013 and 
BS EN 1060-4:2004 standards respectively. Analyses will be conducted 
for the following  populations: 
• 
adults, adolescents, and pediatric patients, who 
are >= 3 years old and atrial fibrillation patients 
(PDM-SuperSTAT arm) 
• 
adults, adolescents and pediatric patients, who 
are ≥3 years old (PSM-Datex-Ohmeda arms) 
• 
neonates and children <3 years of age (PDM-
SuperSTAT arm) 
• 
children <3 years of age and weigh over 5 kg (11 
lbs) (PSM-Datex-Ohmeda arm) 
If deemed necessary by the Sponsor, when the measurement accuracy 
is compromised in a sub-population, affected sub-populations may be 
excluded from analysis 
adults, adolescents, and pediatric patients (both arms), 
neonates and children <3 years of age (PDM-SuperSTAT arm),  
children <3 years of age and weigh over 5 kg (11 lbs) (PSM-Datex-
Ohmeda arm),  
adults, adolescents, and pediatric patients  and atrial 
fibrillationpatients (PDM-SuperSTAT arm) 
 
Removed BS EN 
106004:2004 
requirements 
34 
Section  9.2 Determining 
Reference Invasive Blood 
Pressure Per ISO 81060-
2:2013 
9.2 Determining Reference Invasive Blood Pressure Per ISO 81060-
2:2013 
First, the mean and the standard deviation of the invasive blood 
pressures derived from the IBP wave recordings during a NIBP 
determination will be calculated; and the range of reference invasive 
blood pressure will be determined as mean ±1 standard deviation (SD) 
of the IBPs. The same method will be used for both systolic and 
diastolic blood pressures. Calculation of reference IBP from IBP wave 
recordings is not part of the statistical analysis. All data from a subject 
will be excluded for analysis, when the range of invasive systolic BP is 
wider than 20 mmHg or when the range of invasive diastolic BP is 
wider than 12 mmHg. 
Per BS EN 1060-4:2004 
The range of reference invasive blood pressure will be determined 
using the minimum and maximum of IBPs derived from the IBP wave 
recordings during NIBP determinations. The same method will be used 
for both systolic and diastolic blood pressures. Calculation of reference 
IBP from IBP wave recordings is not part of the statistical analysis. All 
data from a patient with less than 5 NIBP determinations will be 
excluded for analysis. 
 
Removed BS EN 
106004:2004 
requirements 
35 
Section 9.2.9.3. Analysis of 
Subject Characteristics 
The following subject characteristics data will be summarized using 
descriptive statistics if applicable per standard requirements for each 
analysis population by study arm. Continuous variables will be 
described using mean, standard deviation, median, minimum and 
maximum. Categorical variables will be described using count and 
percentage. 
Removed BS EN 
106004:2004 
requirements 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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• 
Number of Adult/adolescents/children/atrial fibrillation 
patients 
• 
Number of patients <1000g, 1000-2000g,>2000g in weight 
• 
Number of patients <29 days, ≥≥29 days and < 1 year of age, 
≥≥ 1 year and < 3 years of age, ≥≥ 3 year and < 12 years of 
age 
• 
Number of patients over 5 kg (11 lbs) and meet one of the 
following: ≥29 days and < 1 year of age, ≥ 1 year and < 2 
years of age, ≥≥ 2 year and < 3 years of age       
• 
Gender 
• 
Height and weight 
• 
Arm Size 
• 
Age 
• 
Number of patients older than 50 years 
• 
Adult and adolescent subjects with mean invasive systolic 
blood pressure ≥ 160 mmHg 
• 
Adult and adolescent subjects with mean invasive systolic 
blood pressure ≤ 100 mmHg 
• 
Adult and adolescent subjects with mean invasive diastolic 
blood pressure ≥ ≥ 85 mmHg 
• 
Adult and adolescent subjects with mean invasive diastolic 
blood pressure ≤≤ 70 mmHg 
• 
Adults, adolescents and children over 3 years old with 1st 
invasive systolic blood pressure ≥ 160 mmHg 
Adults, adolescents and children over 3 years old with 1st  invasive 
systolic blood pressure ≤ 110 mmHg 
Adults, adolescents and children over 3 years old with 1st invasive 
diastolic blood pressure ≥ 100 mmHg 
• 
Adults, adolescents and children over 3 years old with 1st 
invasive diastolic blood pressure ≤ 70 mmHg 
• 
Number of subjects tested on each cuff size 
• 
Arterial sites where IBP was taken 
• 
Heart rate 
 
36 
Section 9.3.1. Data 
Exclusion 
The following NIBP data will be excluded from analysis: 
• 
NIBP data from a subject if the range of reference systolic 
blood pressure is more than 20mmHg or the range of 
reference diastolic blood pressure is more than 12 mm Hg, 
per ISO 81060-2:2013 standard; 
• 
NIBP data from a subject if the number of NIBPs taken is less 
than 5, per EN 1060-4:2004 standard; 
• 
Measurements beyond 10 valid measurements for each 
subject;  
• 
Isolated premature ventricular contractions (PVC) will be 
addressed by removing the pressure associated with the PVC 
and the following compensatory beat.  The PVC will be 
Removed BS EN 
106004:2004 
requirements 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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identified through analysis of the ECG waveform associated 
with the PVC and pulses. This is done during calculating IBPs 
from the IBP wave form, not in the statistical analysis. 
 
37 
Section 9.5. Handling of 
Missing Data 
Every effort will be made to obtain complete data. Data analysis will 
be based on collected data.  Missing data will not be imputed using 
any imputation methods. Missing data is not expected for blood 
pressure values because up to 15 blood pressure determination 
procedures will be allowed, if necessary, to achieve obtain 10 blood 
pressure recordings, thus minimizing the likelihood of missing data in 
IBP and NIBP blood pressure determination pairs. Any pair of blood 
pressure measurements with a missing value will be excluded from 
analysis. 
 
Grammatical correction. 
38 
Section 9.6.Pass/Fail 
Criteria of the Study 
The study will be considered to pass if a sufficient data set is collected 
to satisfy the requirements of ISO 81060-2:2013 and BS EN 1060-
4:2004. 
 
Removed BS EN 
106004:2004 
requirements 
39 
Section 11.4. Management 
of Serious Adverse Event 
and Unanticipated Adverse 
Device Effect Reporting 
Sponsor contact for SAEs and/or UADEs: 
Ron Von Jako, MD 
Telephone: +1 781 262 5579 
Mobile: 
+1-617-669-3200 
Email: 
Ron.VonJako@med.ge.com  
Olli Vaisanen, MD 
Telephone:  +358 40 652 9662 
olli.vaisanen@ge.com 
Fax: 800-888-3983 
E-mail: SAE@ge.com 
 
Updated Medical Director 
name and contact 
information. 
40 
Section 13.1. Regulatory 
Authority Approval 
Requirements (Global) 
There are no applicable global regulatory authority approval 
requirements; however, this study will be conducted in accordance 
with ISO 81060-2:2013 and BS EN 1060-4:2004 standard requirements. 
 
Removed BS EN 
106004:2004 
requirements 
41 
Section 13.4. Informed 
Consent and Privacy 
Requirements 
Informed consent will be documented in the source record of each 
subject. The Investigator or designee will consent the subject per 
regulatory guidelines which include the subject has ample time to 
review the ICF and have all questions answered to their satisfaction; 
the subject may take the ICF home to review with family members or 
others prior to agreeing to participate in the study; upon agreeing to 
participate in the study, the subject signs and dates the document 
while initialing each page, and the person who consented the subject 
signs and dates the document.   
Clarified that initials are 
not required on each page 
per the Sponsor’s current 
global template. 
42 
Section 18. ADDITIONAL 
COUNTRY-SPECIFIC 
REGULATORY 
REQUIREMENTS 
The study will be conducted in accordance with all requirements of ISO 
81060-2:2013 and BS EN 1060-4:2004.. This study will be conducted in 
compliance with BS EN ISO 14155:2011 Good Clinical Practice, per 
international standards. The results of 
 
Removed BS EN 
106004:2004 
requirements 
43 
References 
[Removed references 4 and 5 related to deleted sections] 
 
Removed BS EN 
106004:2004 
requirements 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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44 
Footer 
DOC1466558 
Added Sponsor MWS DOC 
to footer. 
45 
throughout 
[Updated bullets, section heading, page numbering, dates, and 
versions throughout] 
Standard documentation 
and style practices. 
 
 
 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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APPENDIX C: AMENDMENT TO PROTOCOL VERSION 3.0  
Purpose: This amendment document describes in detail the changes made to the study protocol 
to make procedural clarifications and to add additional safeguards for neonate populations 
beyond the scope of the original procedure. Additionally, this amendment clarifies discrepancies 
and simplifies presentation of the risks associated with incidental medications and/or general 
anesthesia administration during study procedures where these concomitant medications are 
clinically indicated outside of the study. 
The following amendments were made to version 3.0 to produce version 4.0. Point-by-point 
revisions are shown as additions in double-underline (double-underline) and deletions in 
strikethrough (strikethrough) for each change made in this amendment for the previous version. 
Item 
Section 
Revision or Clarification 
Justification 
46 
Study Synopsis 
 
Study Title: 
Measurement of 
NonInvasive Blood 
Pressure with DINAMAP 
SuperSTAT and Datex-
Ohmeda  with Intra-
arterial Blood Pressure 
in Neonates through 
Adults and Special 
Populations  (MISSION 
Trial) 
Study Number: 123.04-
2013-GES-0008 
Research Type: 
Clinical (human)        
 
Pre-Clinical (animal)
 
External Bench 
 
Study Number: 123.04-2013-GES-
0008 
Research Type: 
Clinical (human) 
 
Pre-Clinical (animal) 
 
External Bench 
 
 
 
Adjusted formatting for 
clarity and spacing (no 
change in content). 
47 
Study Synopsis 
 
Jeffrey Garland, MD 
Director of Perinatal 
Research 
Wheaton Franciscan 
Healthcare – St. Joseph’s 
 
 
Russel Hirsch, MD  
Associate Professor of 
Pediatrics 
Director, Cardiac 
Catheterization 
Laboratory 
Director, Pulmonary 
Hypertension Service 
Cincinnati Children's 
Hospital Medical Center 
(CCHMC) 
Address:       
5000 West Chambers 
Street 
Milwaukee, WI 53210 
Telephone:   
414- 447-2663 
E-mail: 
    
jsgarland@hotmail.com 
 
Address:      3333 Burnet 
Avenue 
Cincinnati, OH 45229  
Telephone:   
515-636-7072 
E-mail: 
   
Russel.hirsch@cchmc.org  
Updated Sponsor Medical 
Monitor identity and 
contact information. 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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Medical Monitor Name: 
Helena Haukilehto, MD  
Ron Von Jako, MD 
Address: 
Kuortaneenkatu 2, 
Helsinki, 00510 FI 
301 Ballardvale St., 
Suite 4 
Wilmington, MA 01887-
4405 
Telephone: +358-
103943609+1 781 262 
5579 
E-mail:          
Ron.VonJako@med.ge.
com 
helena.haukilehto@ge.
com 
 
 
48 
Section: 2.1. - Literature 
Review 
Accurate blood pressure measurement is essential to providing 
optimal care in hospitals and other clinical settings, and non-invasive 
blood pressure (NIBP) has overwhelmingly become the contemporary 
clinical standard for blood pressure measurement. 11 Accurate blood 
pressure (BP) measurement is dependent on a trained observer using 
validated, calibrated, and properly maintained equipment, which has 
led to increasing emphasis on adherence of commercial NIBP devices 
to validated standards for accuracy and reliability. 2 2 While previous 
studies having have shown that arterial waveforms can be accurately 
and reproducibly reconstructed using oscillometric algorithms, such as 
the DINAMAP® SUPERSTAT and Datex-Ohmeda GE algorithms studied 
in this trial, the accuracy of these NIBP measurement algorithms has 
also been shown to have high variability in patients with variant age 
and cardiac disease status. 3 Thus, there is a need to evaluate these 
algorithms against a validated clinical standard applicable to 
commercial sphygmomanometers. 
…. 
Oscillometric NIBP Measurement 
The basic physiological principles that underlie NIBP technologies were 
first documented in the mid-1970s, and significant improvements have 
since been made in the algorithms that drive NIBP assessment. 6  In the 
past decade, there has been increasing theoretical discourse regarding 
the optimal methods for evaluation of arterial mechanical properties 
and blood pressure pulse using noninvasive oscillometric maximum 
amplitude algorithm (MAA) estimates of the mean blood pressure 
obtained with air-filled occlusive cuffs. 7 These data, once collected, 
can be mathematically extrapolated from experimental IBP 
measurements and waveform simulations and then recorded as 
exponential models. Most recently, automatic NIBP measurement 
systems have come to market that use highly specialized software 
algorithms to account for cuff pressure oscillations caused by the 
peripheral flow of blow blood either as discrete intervals or areas 
under a curve, allowing greater accuracy to be achieved using NIBP 
monitoring methods. 8   As a result, modern NIBP algorithms are 
generally more accurate than their predecessors. 7 
 
 
Corrected typographical 
error. 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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49 
Section 2.2. - Pre-Clinical 
(animal) Trials and 
Previous Clinical (human) 
Experience 
Previous study has indicated that the GE DINAMAP® SuperSTAT 
algorithm on the GE CARESCAPE Patient Monitor Series or DASH® 
Monitor Series is accurate in adult, children, and neonate patients, 
including hypotensive and hypertensive patients. 12 
Added upper limit for 
hypertensive patients for 
clarity and consistency, as 
already specified in 
subsequent document 
sections. 
50 
Section 2.3. - Device Risk 
Analysis 
Participation in this study has no direct benefit to participants; 
however, participants may benefit from more reliable assessment of 
blood pressure readings during their procedure due to the use of 
multiple devices and multiple recordings for blood pressure 
measurement. Participation in this study will not alter the prescribed 
cardiac catheterization procedure recommended by the patient’s 
physician, though the duration of the procedure may be slightly 
increased by a period of time not expected to exceed 20 minutes (1-2 
minutes per NIBP measurement). For neonatal patients, risk will be 
minimized by the inclusion of neonate patients that are being 
catheterized using routine umbilical line catheterization, which has 
been shown to have a minimal complication rate even during longer 
procedures when performed by experienced physicians. 5 Neonatal 
patients may participate for up to three days, taking as few 
determinations as necessary to accomplish research objectives each 
day under the supervision of a medically qualified investigator.The 
NIBP device does not pose additional risks to patients, but there are 
risks associated with the additional IBP comparator procedures above 
the required clinical care for participating subjects. Use of existing 
indwelling lines in very young patients is designed to minimize 
additional disruption of care in pediatric patients. 
 
Clarifications to pediatric 
risk. 
51 
Section 2.3. - Device Risk 
Analysis 
2.3.1 Risk Analysis for Subjects with Indwelling Lines (≤29 
days of age) 
Eligible subjects aged 29 days or less will be recruited only if they 
currently have, or are scheduled to have, an indwelling femoral or 
umbilical arterial monitoring line placed, which has been shown to 
have a minimal complication rate even during longer procedures when 
performed by experienced physicians. 5. For these subjects, NIBP 
measurements will be taken in a minimally disruptive manner in these 
patients in order to minimize possible interruption in their care. No 
additional lines will be placed for study purposes. These patients may 
participate for up to three days, taking as few determinations as 
necessary to accomplish research objectives each day under the 
supervision of a medically qualified investigator. There is not expected 
to be a significant risk to subjects based on placement of 
measurement devices in this study. 
2.3.2 Risk Analysis for Subjects undergoing Non-Emergent 
Aortic Catheterization (aged >29 days to adult) 
Patients aged 29 days or older having prescribed non-emergent aortic 
catheterization procedures will be enrolled. Typical catheterization 
procedures in pediatric patients involve the use of general anesthesia 
for the duration of the clinically indicated procedure. The risks 
associated with general anesthesia are well documented and are 
widely considered safe when prudently administered. 15, 16, 17 Due to 
study participation, the duration of general anesthesia may be slightly 
Additional clarifications by 
population group are 
added for clarity. 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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increased by a period of about 25 minutes (1-2 minutes for each study 
NIBP measurement), after which no further research procedures will 
be performed. General anesthesia is widely recognized as a 
neuromodulator with potential neurotoxic effects; 18, 19, 20, 21, 22, 23 
however, it is widely believed that prudent use of general anesthesia 
in pediatric patients does not pose significant acute or chronic risks to 
patients at routine clinical dosages and non-repeating administrations. 
18, 24, 25 As used in this study, the devices and study procedures are not 
expected to pose significant risks to participating subjects beyond 
those of their clinically indicated catheterization procedure. 
2.3.3 General Controls and Risk Mitigations (all subjects) 
No medicinal agents, including anesthesia and sedatives, are 
specifically required by the study; however, being in the 
study will not prevent subjects from receiving medications 
that are otherwise prescribed for their procedure. Extension 
of administration of general anesthesia consisting of 
approximately 25 minutes is foreseeable. Because repeat 
anesthesia administration has been identified as a central 
risk factor, particularly amongst pediatric subjects, 24 the 
study will not enroll any subject aged greater than 29 days 
but less than 12 years of age that has recently received 
anesthesia outside of the study within the last 3 months. 
Additionally, no subject will be allowed to participate more 
than once to mitigate any possible risks associated with 
repeat anesthesia administrations.  
52 
Section 3.1.1.1 - Patient 
Data Module (PDM) with 
DINAMAP® SuperSTAT 
Algorithm (PDM-
SUPSERSTAT) 
This is accomplished through the useUse of various signal quality 
measures, which is used to reduce the impact of noise 
Typographic correction. 
53 
Section 3.3. - Risk 
Category/Rationale (US 
Only) 
The CARESCAPE Monitor B650, acquisition modules (PDM and PSM), 
and peripheral cuffs and hoses used in this study are cleared for 
commercial use and will be used as intended in their labeling. All 
commercial devices are considered to be IDE Exempt per 21 CFR 
812.2(c)(2).  The DASH® 4000 is a commercial device; however, when 
equipped with the GxP validated non-commercial DC-EDIT and DC-
COLLECTOR tools for data output it is to be used for research purposes 
only. DC-EDIT and DC-COLLECTOR tools are not expected to impact the 
function of the DASH® 4000 device. When equipped with DC-EDIT and 
DC-COLLECTOR, the DASH® 4000 isand algorithms investigated in this 
research study are considered a non-significant risk device per the 21 
CFR 812.3 definition: 
 
Clarification of original 
text. 
54 
Section 4.1. - Hypothesis 
This is a study conducted to satisfy the ISO 81060-2:2013 standard for 
two NIBP devices (PSM-Datex-Ohmeda and PDM-SuperSTAT) and, as 
such, does not require a statistical hypothesis. The Pass/Fail criteria for 
this study are set forthdescribed in Section 9.5 - Pass/Fail Criteria. 
 
Updated Section 
reference. 
55 
Section 4.3.1. - Primary 
endpoints: 
 
Per patient, NIBP and IBP endpoints will be collected for: 
• 
Systolic BP (mmHg) 
• 
Diastolic BP (mmHg) 
• 
NIBP and IBP Mean Arterial Blood Pressure (MAP) 
Adjusted formatting of 
primary endpoint for 
pagination purposes (no 
change to content). 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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For NIBP only: 
• 
Accuracy, determined according to ISO 81060-2:2013  
Per patient, NIBP and IBP 
endpoints will be collected 
for: 
• 
Systolic BP 
(mmHg) 
• 
Diastolic BP 
(mmHg) 
• 
NIBP and IBP 
Mean 
Arterial 
Blood 
Pressure 
(MAP) 
Per patient, for NIBP only: 
• 
Accuracy, 
determined 
according to 
ISO 81060-
2:2013  
 
 
 
56 
Section 5.1. - Type of 
Research Study 
 
Open-Label 
 
Patients or patients’ legal representatives and 
investigators will have knowledge of all 
treatments 
Blinded  
 
 
Double-
Blinded 
 
 
 
Single-site  
 
 
Multi-site 
 
 The study will be conducted at two (2three 
(3) sites 
 
Randomizati
on 
Procedure: 
 
 
Not 
randomized 
 
Patients will consecutively assigned to PDM-
SuperSTAT or PSM-Datex-Ohmeda groups 
based on demographics-based stratification 
quotas, starting with the PDM-SuperSTAT 
group 
Single arm 
 
 
Comparator 
 
 
Parallel 
 
 
Crossover 
 
PatientPatients will receive NIBP and IBP 
assessments, with NIBP type (PDM-
SuperSTAT or PSM-Datex-Ohmeda) 
determined by treatmentstudy arm. Each 
patient will act as their own control for the 
purpose of NIBP vs. IBP comparisons 
Prospective 
 
Patients are enrolled and then undergo study 
procedures. 
 
 
Updated to reflect 
additional site. 
57 
Section 6 – Study Subjects 
6.1 Subject PopulationNumber of Subjects 
The study will include neonates with indwelling femoral or umbilical 
arterial monitoring lines and infant, pediatric, adolescent, and adult 
Removed tables and 
captions for Tables 1-4 and 
replaced with a single 
table and brief summary 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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subjects requiring non-emergent surgery involving aortic 
catheterization (including chronic atrial fibrillation patients among 
adults and adolescents). 
The total minimum enrollment for both algorithm arms is 83 total 
evaluable patients. Non-evaluable patients, as determined by the 
Sponsor per the ISO 81060-2:2013 standard, will not be counted 
towards the minimum quota requirements. Enrollment will continue 
until the minimum evaluable patient enrollment and distribution 
requirements of the ISO 81060-2:2013 standard are met. Total 
patient enrollment in both arms will not exceed 200 patients. 
The two NIBP measurement arms in this study are:  
PDM-SuperSTAT Arm (minimum of 45 evaluable patients): GE 
DINAMAP® SuperSTAT algorithm delivered by the PDM acquisition 
module connected to the CARESCAPE Monitor B650 
PSM-Datex-Ohmeda Arm (minimum of 38 evaluable patients): 
Datex-Ohmeda  delivered by the PSM acquisition module connected 
to the CARESCAPE Monitor B650 
Each patient may only be included in one study arm. No patients will 
be treated with more than one NIBP device. These stratification 
quotas are fully described along with additional standard-specific 
requirements in Tables 1 to 4. 
6.12 Summary of Patient Stratification Requirements 
Patient enrollment is summarized in the following sections by study 
arm; however, full details on patient enrollment requirements, 
including gender and health condition requirements, are found in 
Tables 1 to 4. 
PDM-SuperSTAT Arm 
Minimum of 45 evaluable subjects, including: 
This study intends to c≥15 adults and adolescents >12 years old 
≥5 pediatric (≥3 to ≤12 years old), 
≥7 Atrial Fibrillation Patients 
≥18 neonates(≤28 days) and infants/children (≥29 days to <3 years 
old) 
ollect 10 paired measurements (NIBP and IBP) per patient, and will 
collect a minimum of: 
≥270 valid blood pressure measurement pairs should be obtained 
for patients ≥3 years old 
≥150 valid blood pressure measurement pairs should be obtained 
for patients <3 years old 
 
PSM-Datex-Ohmeda Arm 
Minimum of 38 evaluable subjects, including: 
≥15 adults and adolescents >12 years old 
≥5 pediatric (≥3 to ≤12 years old), 
≥ 18 infants/children (<3 years old and weighing >5 kg)  
This study intends to collect 10 paired measurements (NIBP and IBP) 
per patient, and will collect a minimum of: 
≥200 valid blood pressure measurement pairs should be obtained 
for patients ≥3 years old 
≥150 valid blood pressure measurement pairs should be obtained 
for patients <3 years old weighing >5 kg (approximately 11 lbs) 
for clarity. No change in 
intended target 
population. 
 
Section 6.2 and Table 1 
replace all prior text. 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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Adolescent and/or adult, pediatric, and neonatal patients 
and special patients with chronic atrial fibrillation that 
require prescribed heart catheterization will be enrolled 
according to the inclusion/exclusion and stratification 
criteria on a quota block basis. For the purposes of this 
study, chronic atrial fibrillation will be defined as persistent 
or sustained atrial fibrillation which does not stop 
spontaneously. 
6.3.1 Enrollment Strategy for Stratification Groups 
The stratification quotas set forth in the following sections should be 
individually met for both the PSM-Datex-Ohmeda and PDM-
SuperSTAT study arms. 
Patients will be consecutively enrolled until each stratification quota 
reaches its minimum quota for enrollment per study arm. When the 
minimum number of patients is enrolled, enrollment will end on a 
per-strata basis. When all strata have reached their minimum 
enrollment targets, additional patients may be consecutively 
enrolled that meet any stratification criteria in order to reach the 
target total patient enrollment number described in Section 6.1 – 
Number of Subjects, and to meet the patient distribution 
requirement set forth in the ISO 81060-2:2013 standard. 
6.3.1 Minimum Patient Numbers and Cuff Sizes 
Both the PDM-SuperSTAT and PSM-Datex-Ohmeda arms are 
required to individually fulfill the requirements of ISO 81060-2:2013, 
including that the minimum number of patients is a function of the 
number of available cuff sizes, according to the equation for the 
percentage of total evaluable patients. In this study, a total of 6 (5 
arm cuffs including on for infants and 1 thigh cuff) GE Critikon SOFT-
CUF® occlusive blood pressure cuff sizes will be investigated in 
infants through adults and 5 GE Critikon CLASSIC-CUF® occlusive 
blood pressure cuff sizes will be investigated in neonates. Per 
ISO81060-2:2013, for a sphygmomanometer intended for use with 
multiple cuff sizes, at least 
1
2×𝑛 of the subjects shall be tested with 
each cuff size, where n is the number of cuff sizes; and neonates, 
infants and children <3 years of age are exempt from this 
requirement. Thus, n equals 5 for this study for patients ≥3 years of 
age, and each cuff size should be tested in at least 10% of those 
patients. 
Based on this requirement and additional ISO 81060-2:2013 
guidelines for patient characteristics by demographic group, the 
minimum patient requirements for this study are described in detail 
in Tables 1-4. 
6.3.3 Stratification of Adult Patients 
Enrollment of adult patients will be the same in both study arms 
(PSM-Datex-Ohmeda and PDM-SuperSTAT) except that additional 
special population patients (chronic atrial fibrillation patients) will be 
included in the PDM-SuperSTAT stratification groups by age and 
gender, as shown in Table 1. 
Table 1 – Summary of Adult and Adolescent Patient Enrollment 
Stratification by Age and Gender  
Abbreviations: M = male; F = female; n, number of patients 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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Note: # 30% of population to be male and 30% of population to be 
female 
* chronic atrial fibrillation patients will be included only in the 
PDM-SuperSTAT arm 
Stratification of Pediatrics 
The enrollment of pediatric patients (aged ≥3 AND ≤12 years) will 
be the same in both study arms (PSM-Datex-Ohmeda and PDM-
SuperSTAT), as described in Table 2.  
Table 2 – Pediatric Enrollment Stratification by Age and Gender 
Abbreviations: M = male; F = female; n, number of patients 
Note: # 30% of population to be male and 30% of population to be 
female 
 
 
Stratification of Children, Infant, and Neonatal Patients  
The enrollment of children < 3 years of age will be the different in 
each study arm (PDM-SuperSTAT and PSM-Datex-Ohmeda), as 
described in Tables 3 and 4, respectively. There will be no 
stratification by gender. The neonates will not be evaluated by the 
PSM-Datex-Ohmeda module.3 – PDM-SuperSTAT arm: Pediatric 
and Neonatal Enrollment Stratification by Age and Weight 
* infant and child patients under 3 years of age will be examined 
using one of 6 GE Critikon SOFT-CUF® occlusive blood pressure 
cuffs 
#Abbreviations: M = male; F = female; n, number of patients 
 
 
Table 4 – PSM-Datex-Ohemda: Infants and Children under 3 years 
of age and weighing >5 kg (approximately 11 lbs)* infant, and 
children patients under 3 years of age will be examined using one 
of 6 GE Critikon SOFT-CUF® occlusive blood pressure cuffs 
Abbreviations: M = male; F = female; n, number of patients# Only 
patients weighing >5 kg (approximately 11 lbs) can be examined 
with PSM-Datex-Ohemda under the current FDA-approved 
labeling 
Additional Requirements: 
Additional requirements for patient distribution required by ISO 
81060-2:2013 are listed below: 
Limb Size Distribution (ISO 81060-2:2013) 
Among adult, adolescent and children over 3 years old, a minimum of 
10% patients will be examined using each of the 5 cuff sizes for 
children and adults. Enrollments for PDM-SuperSTAT will include at 
least 3 patients for each cuff; and enrollments for PSM-Datex-
Ohmeda will include at least 2 patients for each cuff. 
Blood Pressure Distribution (ISO 81060-2:2013) 
Among adult and adolescent patients, at least 10% patients will be in 
each of the following four BP groups: 
10% systolic BP ≤100 mmHg 
10% systolic BP ≥160 mmHg 
10% diastolic BP ≤ 70 mmHg 
10% diastolic BP ≥ 85 mmHg 
Note: Neonates, infants, and children less than 12 years old are 
exempt from this requirement. The mean of the reference invasive 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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systolic and diastolic blood pressure measurements taken during the 
study will be used in calculation. 
 
…. 
6.3 Number of Subjects 
The total minimum enrollment for the two study arms is 83 
total evaluable patients (maximum of 200 patients), as 
follows:  
3. 
PDM-SuperSTAT Arm (NPDM): 45 evaluable patients 
with GE DINAMAP® SuperSTAT algorithm (PDM 
Module) on CARESCAPE Monitor B650, to achieve a 
total target of ≥270 BP data pairs in patients ≥3 years 
old (up to 10 paired measurements per subject) and 
≥150 BP data pairs in patients <3 years old (up to 10 
total paired measurements per subject, up to one per 
hour). 
4. 
PSM-Datex-Ohmeda Arm (NPSM): 38 evaluable patients 
with Datex-Ohmeda algorithm (PSM module) on 
CARESCAPE Monitor B650, to achieve a total of ≥200 
BP data pairs in patients ≥3 years old (up to 10 paired 
measurements per subject) and ≥150 BP data pairs in 
patients <3 years old (up to 10 total paired 
measurements per subject, up to one per hour). 
6.3.1 Stratification of Subjects 
Subject enrollment will be stratified based on prospective criteria to 
ensure diversity in the population, as described in ISO 81060-2:2013 
and set forth in Table 1. Patients will be enrolled concurrently in both 
arms until all minimum quotas are reached, and thereafter up to the 
maximum enrollment for the study. Incomplete/non-evaluable 
datasets, as determined by the Sponsor, will not be considered to 
satisfy minimum requirements in Table 1. Additionally, multiple cuff 
sizes will be used, including a minimum of 1/(2 x n) per stratification 
group , where n is the total within a stratification group able to be 
tested using the cuff in accordance with its labeling (Table 1) 
Table 1 – Summary of Patient Enrollment Stratification by 
Characteristics 
[Added Table 1] 
 
58 
Section 6.2 - Protection of 
Vulnerable Subjects 
The information collected in this study could not have been obtained 
in a less vulnerable, consenting population, necessitating the use of 
minor patients. Adolescent, pediatric, and neonatal patients will be 
recruited and enrolled according to all US FDA, ICH E6ISO 14155:2011 
GCP, and GLPother applicable local requirements for protection of 
vulnerable subjects. Special measures will be taken to protect the 
rights of these vulnerable study participants and to shield them from 
undue risk. These patientsStudy procedures for neonate subjects will 
be modified to minimize interruption in normal medical care, including 
limiting sampling to once per hour. will be recruited without undue or 
inappropriate inducements to the parent or legal guardian, and 
informed consent and assent, when appropriate, will be collected as 
described in Section 13.4 Informed Consent and Privacy Requirements. 
For patients capable of providing assent, assent will be required for 
Updated standards to 
make corrections and 
added detail about 
pediatric patient risk 
mitigations, and to limit 
redundancy. 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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participation in this study in addition to informed consent from 
parent(s) or legal guardian(s).Inclusion Criteria  
 
59 
Section 6.3. Number of 
Subjects 
The total minimum enrollment for the two study arms is 83 total 
evaluable patients (maximum of 200 patients), as follows:  
1. 
PDM-SuperSTAT Arm (NPDM): 45 evaluable patients with GE 
DINAMAP® SuperSTAT algorithm (PDM Module) on 
CARESCAPE Monitor B650, to achieve a total target of ≥270 
BP data pairs in patients ≥3 years old (up to 10 paired 
measurements per subject) and ≥150 BP data pairs in 
patients <3 years old (up to 10 total paired measurements 
per subject, up to one per hour). 
2. 
PSM-Datex-Ohmeda Arm (NPSM): 38 evaluable patients with 
Datex-Ohmeda algorithm (PSM module) on CARESCAPE 
Monitor B650, to achieve a total of ≥200 BP data pairs in 
patients ≥3 years old (up to 10 paired measurements per 
subject) and ≥150 BP data pairs in patients <3 years old (up 
to 10 total paired measurements per subject, up to one per 
hour). 
 
 
Simplified the 
presentation of 
requirements, for clarity to 
investigators. No change in 
total enrollment. 
60 
Section 6.3.1. - 
Stratification of Subjects 
Subject enrollment will be stratified based on prospective criteria to 
ensure diversity in the population, as described in ISO 81060-2:2013 
and set forth in Table 1. Patients will be enrolled concurrently in both 
arms until all minimum quotas are reached, and thereafter up to the 
maximum enrollment for the study. Incomplete/non-evaluable 
datasets, as determined by the Sponsor, will not be considered to 
satisfy minimum requirements in Table 1. Additionally, multiple cuff 
sizes will be used, including a minimum of 1/(2 x n) per stratification 
group (except for the children/infants/neonates group) , where n is 
the total within a stratification group able to be tested using the cuff in 
accordance with its labeling (Table 1). 
 
[Revision to Table 1] 
Simplified the 
presentation of 
requirements, for clarity to 
investigators. No change in 
total enrollment. 
 
Combined multiple tables 
in Table 1 to one table for 
clarity. There are 
modifications to the 
presentation of 
stratification groups 
designed to aid in 
enrollment. 
61 
Section 6.4. - Inclusion 
Criteria 
Subjects will be included that: 
1. 
 Require non-emergent heart catheterization, if greater than 3 
years of age; subjects less than 3 years of age will be assessed 
using indwelling radial/femoral/pedal or umbilical arterial 
monitoring lines; Are aged >29 days requiring clinically indicated 
non-emergent heart catheterization OR aged ≤29 days with 
placed or scheduled placement of an indwelling femoral or 
umbilical arterial monitoring line; 
2. 
side) that fits a cuff size of the device (circumference ranging 3 
cm to 40 cm) OR have a thigh (right OR left side) that fits a cuff 
size of the device (circumference ranging 38 to 50 cm); 
3. 
Are willing andexpected to be able to provide blood pressure 
measurements using both IBP and NIBP; 
4. 
Are able and willing to provide written informed consent or have 
a legally authorized representative willing to provide written 
informed consent with assent from minor patients, ifas required 
by IRB policy. 
 
Revised to clearly indicate 
requirements for neonates 
as well as other 
populations. Notably, 
special controls for 
neonatal subjects are in 
place, including only use of 
existing indwelling lines. 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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62 
Section - 6.5 Exclusion 
Criteria 
Subjects will be excluded that: 
1. 
Have previously participated in this study (no subject may 
participate more than once). 
2. 
Exhibit signs or symptoms or have a current diagnosis of 
peripheral vascular disease in either upper AND/OR lower limbs; 
3. 
Have current, uncontrolled circulatory shock; 
4. 
Exhibit injuries, deformities, intravenous lines, or other 
abnormalities that, in the opinion of the investigator, may 
prevent proper cuff application or functioning; 
5. 
Are For women of child-bearing potential, are currently pregnant, 
suspect that they are suspected to be pregnant, or are currently 
lactating; 
6. 
 Have any other condition that makes the subject unable to 
tolerate 4 fast flushes (adult, adolescent, or pediatric) or 1 fast 
flush (neonates and children <3 years of age) for dynamic 
calibration without posing a risk to the patient’s physiological 
stability; Have any condition that could interfere with the 
subjects ability to tolerate the procedure, including having a 
maximum of 4 fast flushes (adult, adolescent, or pediatric 
patients aged >29 days) or 1 fast flush (neonates aged <29 days); 
7. Are under general anesthesia. 
7. 
If aged greater than 29 days but less than 12 years of age, have 
previously had any clinical or research procedure requiring 
general anesthesia in the last 3 month period; 
8. 
If aged greater than 29 days but less than 12 years of age, are 
expected to require more than three (3) total hours of 
continuous general anesthesia for the scheduled procedure 
(including clinically necessary anesthesia and anticipated 25 
minute extension for study purposes). 
 
Specified than no subject 
may participate more than 
once as an additional 
protection. 
 
Clarified that pregnancy 
testing is only required for 
potentially child-bearing 
subjects (not 
children/neonates). 
 
Added additional 
protections for pediatric 
and neonatal subjects. 
63 
Section 6.6. -Screening 
Subjects for Enrollment 
6.6 Screening Subjects for Enrollment 
There are three (3) investigational clinical sites involved in this clinical 
trial. Patients will be screened for enrollment by the investigational 
site according to their standard procedure, in accordance with IRB 
policy. All patients will be consecutively screened and enrolled first 
into the PDM-SuperSTAT group if eligible. Remaining patients will then 
be screened for the PSM-Datex-Ohmeda group. All patient enrollment 
will be conducted according to the stratification criteria and 
inclusion/exclusion criteria. 
 
 
Added third site. 
 
Removed incomplete 
description of population, 
which is presented in 
greater detail in the added 
sections above to avoid 
possible confusion 
between populations 
under study. 
64 
(moved) Section 7.1.1. - 
Baseline Examination (all 
sites) 
7.2.1. 
Baseline Examination 
For enrolled patients that have provided informed consent the 
following baseline information will be collected on CRFs after informed 
consent requirements have been satisfied and before the procedures 
are performed: 
1. 
Demographics (Ageand Gender) 
2. 
Height and Body Weight 
3. 
Relevant Medical History  
4. 
Physiological Condition (Stable/Unstable)  
5. 
Urine pregnancy test, if applicable (females of childbearing 
potential) 
6. 
Arm or Thigh Circumference (cm) 
Moved section to 7.2.1, for 
clarity.  

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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7. 
Appropriate Cuff Brand (Critikon® Soft-Cuf or Classic-Cuf) 
and Size 
8. 
Baseline Non-Invasive Blood Pressure (NIBP), consisting of 
systolic blood pressure (SBP) and diastolic blood pressure 
(DBP)   
9. 
Location of NIBP Measurement (Arm/Thigh) and measuring 
circumstance 
10. Mean Arterial Pressure (MAP) 
11. Current medications 
12. Pulse rate 
 
65 
Section 7.1 - Setup 
Procedures 
7.1 Required Setup Procedures  
7.1.1 IBP Data Collection on the Data Collection System (DCS) 
IBP and ECG data will be collected using a DASH® 4000 patient monitor 
with the hardware and software tools to connect to a computerized 
data collection system (DCS) housed on a Sponsor-provided laptop 
computer. One DCS (laptop) will be connected to the DASH® 4000 via 
a serial cable from the DASH to the DCS laptop. The investigator is 
responsible for setting up the DCS for collection of IBP data according 
to the “Setup of Data Collection” section of the Device Set-Up Manual 
provided by the Sponsor. The control panel for the DASH® 4000 
patient monitor is shown in the “DASH® 4000 Control Panel” section of 
the section of the Device Set-Up Manual provided by the Sponsor, 
which provides details on user setup and operation of the DASH® 4000 
patient monitor. 
The patient procedure for IBP setup is shown in the “IBP Setup” 
section of the Device Set-Up Manual provided by the Sponsor. 
 
Added reference to 
manual. 
66 
Section 7.1.2. - NIBP Data 
Collection 
NIBP will be recorded on a commercial CARESCAPE Monitor B650 with 
most recent commercial software version installed. NIBP data will be 
transcribed by hand from the display of the CARESCAPE B650 monitor 
onto the Sponsor-provided Case Report Form (CRF). 
For patients in the PDM-SuperSTAT arm of the study, NIBP will be 
measured with a CARESCAPE Monitor B650 equipped with a PDM 
acquisition module. For patients in the PSM-Datex-Ohmeda arm of the 
study, NIBP will be measured with a CARESCAPE Monitor B650 
equipped with a PSM acquisition module. Each patient may only be 
included in one study arm. No patients will be treated with more than 
one NIBP device. 
Removed duplicate. 
67 
Section 7.2.2 - Before the 
Procedure 
7.2.2 Before the Procedure and Procedure-Specific Assessments 
For each patient, the following procedure-specific information will be 
recorded on CRFs: 
 
Clarified section title. 
68 
Section 7.2.2 - Before the 
Procedure 
Static Calibration of the IBP System 
Static response (ability of the monitoringThree ECG sensors will be 
placed with leads on the left and right arm and left leg connected to 
the DASH® 4000.  
Before each patient procedure, static calibration will be conducted for 
the IPB system to accurately determine constant pressure) and 
dynamic response (accurately reproducing rapid changes in pressure) 
affect IBPensure measurement accuracy. Therefore, static calibration 
(“ according to the “Static Calibration” section of the Device Set-Up 
Clarified language to 
improve clinical 
readability. 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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Manual provided by the Sponsor) will be performed prior to each 
patient procedure. 
. Each system will be calibrated at 5 static pressures spread across the 
working range of the device to be tested. During calibration, values 
will be, recorded foras: 
1. 
Pressure for each of the 5 calibration static 
pressures tested 
2. 
Calibration completion status 
(success/fail) 
3. 
Descriptions of any errors during any 
static calibration procedure 
ECG Placement and Setup 
Three ECG sensors will be placed on patients aged ≥29 days, 
with leads on the left and right arm and left leg connected 
to the DASH® 4000. No ECG will be captured for subjects 
aged <29 days.Arterial Catheterization 
69 
Section 7.2.3. - Patient 
Procedures 
7.2.3 Patient Procedures 
Each patient will undergo intra-arterial aortic catheterization 
according to the standard of care at the investigational site. All tubing, 
transducers, and stopcocks will be filled with fluid and purged of all 
bubbles prior to data recording for IBP or NIBP in this study. If general 
anesthesia and/or other medicinal products are prescribed outside of 
the study, they will be administered according to the local standard of 
care prior to study measurements.The patient procedure for IBP setup 
is shown in the “IBP Setup” section of the Device Set-Up Manual 
provided by the Sponsor. 
Dynamic Calibration of the IBP System 
 Dynamic calibration will be performed in the beginning of each 
procedure according to the “Dynamic Calibration” section of the 
Device Set-Up Manual provided by the Sponsor.  For patients that the 
procedure will extended beyond one day, dynamic calibration will be 
conducted once each day prior to determinations. A maximum of 1 
flush is to be conducted for patients aged <3 years.29 days. A 
maximum of 4 flushes may be conducted for patients aged ≥3 29 
daysyears. During calibration, values will be recorded for: 
1. 
Number of fast flushes 
2. 
Damping  coefficient 
3. 
Natural frequency 
For subjects less than 29 days of age, care will be taken to minimize 
disruption of care, and, when possible, procedures will be performed 
during times when feeding or other care is provided. 
 
Added section heading, 
and clarified and separate 
patient procedural 
information. 
70 
Section 7.2.4 - Blood 
Pressure Assessments 
7.2.4 Blood Pressure Assessments 
NIBP will be measured using the CARESCAPE Monitor B650 patient 
monitor equipped with an acquisition module (either PDM-SuperSTAT 
or PSM-Datex-Ohmeda, determined by study arm). IBP will be 
measured using the DASH® 4000 plus DC-COLLECTOR and DC-EDIT 
software. During the blood pressure assessments, values will be 
recorded for: 
11. Study Arm 
Consolidated information 
into a single table for 
clarity (new Table 2). This 
reduces the number of 
tables to make the 
protocol easier to follow. 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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12. Time of first and last blood pressure measurement 
13. Systolic, Diastolic, Mean, Test Duration 
14. If the prescribed wait time was taken between tests 
15. Any measurements with no determination 
Both NIBP and IBP assessments will be conducted simultaneously, with 
IBP data collected on the DCS and NIBP data recorded by hand onto a 
paper Case Report Form (CRF). If necessary, assistance will be 
provided by other study staff to ensure that accurate and 
simultaneous blood pressure data is recorded. 
IBP data will be continuously collected throughout the study and NIBP 
data will be recorded according to the following procedure: 
12. Use the patient monitor equipped with either PDM-SuperSTAT or 
PSM-Datex-Ohmeda according to the patient’s study arm to 
determine the patient's blood pressure. 
13. Clear the patient monitor memory of the previous determination 
and wait at least 3 min  
Note: For the CARESCAPE Monitor B650, the memory can only be 
cleared by discharging the case (with acquisition module 
attached) 
 
14. Have the observers using the reference IBP monitoring 
equipment (DASH® 4000) and the NIBP monitoring equipment 
(CARESCAPE Monitor B650 with either PSM or PDM) 
simultaneously record and determine the patient's blood 
pressure, as follows. 
a. 
Start continuous collection on the IBP DCS system at 
the same time as recording of NIBP begins 
b. 
Collect each NIBP measurement from the CARESCAPE 
Monitor B650 
c. 
Discharge the patient monitor to clear the memory of 
the previous NIBP determination after each 
determination.  
Note: Because the discharge will erase the data from the 
previous NIBP measurement, record all necessary values 
before discharging the 
15. Wait the following amount of time (Table 6) between 
determinations or, for neonatal patients, 3 min. 
16. Table 6 – Minimum Time between Determinations 
Population Age 
Minimum Wait Period 
≥ 3 years 
≥60 seconds 
> 29 days old to 3 
years 
≥60 seconds 
‹ 29 days 
≥3 minutes (variable)* 
*Wait period is based on the investigator’s discretion of patient 
health status of the patient. It is, however, suggested that a 20 
minute wait period may be appropriate between 3 
determinations obtained within a 2 hr window OR 4 
determinations obtained within a 3 hr window. 
17. Wait the appropriate amount of time between determinations 
(as defined in Table 2). 
18. Repeat steps 4, 5, and 63 and 4 adhering to the requirements in 
Table 2 until the target number of recordings and determinations 
have been performed or the subject leaves the study. In the 
event that any blood pressure determination is not successful, 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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the procedure may be repeated to achieve the target number of 
successful blood pressure determinations. No more than the 
maximal number of total blood pressure determinations as 
specified in Table 5 2 will be performed on any patient. 
Neonates Only: Neonatal patients may participate for up to three 
days, taking an average of 3-4 determinations each day at the 
investigator’s discretion. 
19. When all NIBP measurements are complete, stop the IBP data 
collection. 
 
Table 2 – Number of Blood Pressure Assessments and 
Frequency 
Population 
Maximu
m 
Number 
of BP 
Determi
nations 
Target 
Number of 
Valid BP 
Determina
tions 
Frequency 
of 
Determina
tions 
Pediatric, 
Adolescent
s, and 
Adults 
(aged ≥ 3 
years) 
15 max 
attempts 
10 
determinat
ions 
At least 60 
s between 
determinat
ions  
Children & 
Infants (<3 
years old to 
>29 days 
old) 
10 max 
attempts  
10 
determinat
ions 
At least 60 
s between 
determinat
ions 
Neonates (‹ 
29 days 
old) 
10 max 
attempts 
5-10 
determinat
ions 
At least 3 
minutes 
between 
determinat
ions (over 
max of 72 
hours) 
71 
Section 7.4 - Withdrawal 
and Discontinuation 
Criteria 
 
The patient may withdraw from study participation at any time, for 
any reason without consequence. The Investigator may withdraw a 
patient at any time for any reason. The reasons for withdrawal and 
discontinuation for any patient shall be recorded. These will be 
reported to the Sponsor. The EC/IRB should be notified per their 
notification of patient withdrawal policy. 
If the Sponsor conducts a review during this study that indicates a 
total patient enrollment in any stratification group that meets or 
exceeds the number required to satisfy the ISO 81060-2:2013 
standards, the Sponsor may discontinue or continue enrollment in any 
stratification Data collected up until the time of withdrawal may still 
be disclosed to the Sponsor as part of this study to ensure the integrity 
of research data. 
Continuation and discontinuation of enrollment in any stratification 
group will be made at the discretion of the Sponsor in the context of 
applicable regulatory and standards requirements, and the 
Clarified criteria for 
withdrawal and 
discontinuation. 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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Investigator will be notified by the Sponsor upon such a 
determination. 
 
72 
Section 9.1.1. - Analysis 
Populations 
Separate analysis will be performed for PSM-Datex-Ohmeda and the 
PDM-SuperSTAT arms per requirements of the ISO 81060-2:2013 
standard. Analyses will be conducted for the following populations: 
• 
adults, adolescents, and pediatric patients, who 
are ≥ 3 years old and chronic atrial fibrillation 
patients (PDM-SuperSTAT arm) 
 
Added term for 
consistency of 
terminology. 
73 
Section 11.1 - Foreseeable 
Adverse Events and Device 
Effects 
ForeseeableThe study procedure requires adding NIBP measurements 
to a patient’s procedure. While NIBP is non-invasive, there are some 
foreseeable risks associated with NIBP include, as follows: 
• 
slight discomfort upon inflation of the cuff,  
• 
possible bruising, 
• 
petechial rash 
• 
discoloration of the skin beneath the cuff 
• 
peripheral nerve injuries 
• 
skin avulsion 
• 
compartment syndrome 
• 
ischemia 
 
Foreseeable risks associated with IBP include: 
Whether or not the patient participates in the study, there are risks to 
having indwelling monitoring lines placed or having non-emergent 
aortic catheterization procedures with or without general anesthesia. 
To protect neonatal subjects, only subjects with existing indwelling 
monitoring lines will be enrolled, and no indwelling lines will be placed 
for study purposes. Foreseeable risks associated with these invasive 
procedures, as required for IBP, include: 
• 
Bruising 
• 
Bleeding 
• 
Heart attack 
• 
Stroke 
• 
Damage to the artery where the catheter was inserted that 
may require additional attention (pseudoaneurysm), 
including shear damage 
• 
Irregular heart rhythms (arrhythmias) 
• 
Allergic reactions to the dye or medication 
• 
Tearing the tissue of your heart or artery 
• 
Kidney damage 
• 
Infection 
• 
Blood clots 
• 
Ischemia 
• 
Air embolism 
• 
Potentially serious reactions to prescribed general 
anesthesia and/or sedatives 
 
While general anesthesia is not a requirement of this study, it is 
foreseeable that some patients undergoing aortic catheterization 
procedures will be incidentally administered prescribed general 
anesthesia and/or other sedatives during the study. Though general 
anesthesia is widely considered safe for routine clinical use, it is known 
Updated to reflect the 
Sponsor’s review of the 
literature, which includes 
addressing risks of 
possible concomitant 
general anesthesia in 
subjects of this study. 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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Justification 
to be a potent neuromodulator with potentially serious documented 
side effects. 18, 21, 22, 23, 24, 25, 19 This research involves extension of the 
procedure by approximately 25 minutes to collect data, which may 
incidentally extend prescribed anesthesia and/or other medication 
administration. Though no definitive cumulative or long-term effects 
of general anesthesia are known with certainty, 24 to mitigate against 
these possible risks the study will not enroll subjects that have history 
of repeated recent anesthesia, and no subject will be allowed to 
participate more than once in the study. The risks associated with 
general anesthesia during this study are not expected to be 
significantly higher than those that the subject would have otherwise 
been exposed to had he or she not participated in this research. 
 
73 
Section 11.4. - 
Management of Serious 
Adverse Event and 
Unanticipated Adverse 
Device Effect Reporting 
Helena Haukilehto, MD  
Ron Von Jako, MD 
Telephone: +358-103943609+1 781 262 5579 
Email: 
Ron.VonJako@med.ge.com 
Email: 
helena.haukilehto@ge.com 
 
Updated Sponsor medical 
director name and contact 
information. 
74  
Section 17. ADDITIONAL 
STUDY MATERIALS / 
ADDITIONAL COUNTRY-
SPECIFIC REGULATORY 
REQUIREMENTS 
17. Additional Study Materials / Additional Country-Specific Regulatory 
Requirements 
 
Combined supplementary 
section headings and 
placed references at end 
of document. 
 
 
 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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APPENDIX D: AMENDMENT TO PROTOCOL VERSION 4.0  
Purpose: This amendment document describes in detail the changes made to the study protocol 
to make procedural clarifications and to clarify additional safeguards and reporting for neonate 
populations. Additionally, this amendment corrects formatting and wording issues to ensure 
clarity and consistency within the document and between the document and applicable 
standards. 
The following amendments were made to version 4.0 to produce version 5.0. Point-by-point 
revisions are shown as additions in double-underline (double-underline) and deletions in 
strikethrough (strikethrough) for each change made in this amendment for the previous version. 
Item 
Section 
Revision or Clarification 
Justification 
75 
Study Synopsis 
 
Medical Monitor Name: 
Helena Haukilehto, MD  
 
Address:     
Kuortaneenkatu 2 
Helsinki, 00510 FI 
Telephone:  
 
+358-103943609 
 
E-mail:          
hHelena.haukilehtoHaukile
hto@ge.com 
 
 
Typographical correction 
in email (capitalization 
only). Corrections in 
spacing are made to 
ensure consistency of the 
display of the synopsis for 
screen and print viewing. 
76 
Section 2.3.1. Risk Analysis 
for Subjects with 
Indwelling Lines (≤29 days 
of age) 
For these subjects, NIBP measurements will be taken in a minimally 
disruptive manner in these patients in order to minimize possible 
interruption in their care. 
Typographical correction 
to remove repeated 
phrase appearing twice in 
this sentence. 
77 
Section 6.2. Protection of 
Vulnerable Subjects 
The information collected in this study could not have been obtained 
in a less vulnerable, consenting population, necessitating the use of 
minor patients. Adolescent, pediatric, and neonatal patients will be 
recruited and enrolled according to all US FDA, ISO 14155:2011 GCP, 
and other applicable local requirements for protection of vulnerable 
subjects. Special measures will be taken to protect the rights of these 
vulnerable study participants and to shield them from undue risk. 
Study procedures for neonate subjects will be modified to minimize 
interruption in normal medical care, including limiting sampling to 
once per hour. Study procedures for pediatric and neonate subjects 
will be modified to minimize interruption in normal medical care, 
which includes additional limitations on sampling frequency beyond 
the minimums suggested by ISO 81060-2:2013 (as shown in Table 2) 
for the general population. This is done to ensure minimal risk for 
participating subjects. 
 
Table 2 was added in the 
prior amendment to detail 
requirements for sampling 
per population. The risk 
section is revised to reflect 
that a detail of risks is now 
included in Table 2 
(referenced to Table 2 to 
clarify this). 
 
Note, these requirements 
are still in addition to the 
minimums posed by the 
standard, and there is no 
intended change in risk 
based on this revision, 
which is intended to clarify 
the document. 
78 
Section 6.3. Number of 
Subjects 
The total minimum enrollment for the two study arms is 83 total 
evaluable patients (maximum of 200 patients), as follows:  
1. PDM-SuperSTAT Arm (NPDM): 45 evaluable patients with GE 
DINAMAP® SuperSTAT algorithm (PDM Module) on CARESCAPE 
Monitor B650, to achieve a total target of ≥270 150 BP data 
Subject populations are 
updated for consistency 
with the standard and to 
reflect the addition of 
sampling limitations per 
population in Table 2 (as 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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pairs in patients ≥3 years old (up to 10 paired measurements 
per subject) and ≥150 BP data pairs in patients <3 years old (up 
to 10 total paired measurements per subject, up to one per 
houras described in Table 2). 
2. PSM-Datex-Ohmeda Arm (NPSM): 38 evaluable patients with 
Datex-Ohmeda algorithm (PSM module) on CARESCAPE 
Monitor B650, to achieve a total of ≥200 150 BP data pairs in 
patients ≥3 years old (up to 10 paired measurements per 
subject) and ≥150 BP data pairs in patients <3 years old (up to 
10 total paired measurements per subject, up to one per hour) 
(as described in Table 2). 
 
described in Amendment 
78). 
79 
Section 6.3.1. Stratification 
of Subjects 
Table 1 – Summary of Patient Enrollment Stratification by 
Characteristics 
Abbreviations: M = male; F = female; n, number of patients 
* No age requirement within the children/infant/neonates category ma
include subjects aged birth to <3 yrs 
# Investigators should equitably represent male and female patients, 
which must each make up a minimum of 30% of the final population 
upon completion (i.e. at least 30% male and 30% female, the 
remaining 30% may be either male or female based on enrollment). 
Important: Additional Stratification requirements 
a Only patients weighing >5 kg (approximately 11 lbs) can be examined 
PSM-Datex-Ohemda under the current labeling 
b Among adults/ and adolescents, at least 10% should have baseline sys
of  ≤100 and ≥160 as well as diastolic BP of ≤ 70 and ≥ 85 mmHg 
 
Added clarification that  
subjects ages <29 days 
may be included in the 
children/Infants/Neonates 
stratification group, up to 
the allowable total patient 
number per PDM/PSM 
module. This reflects the 
original intent of this table 
and clarifies the original 
study intent. 
80 
Section 7.2.1. Baseline 
Examination 
For enrolled patients that have provided informed consent the 
following baseline information will be collected on CRFs after informed 
consent requirements have been satisfied and before the procedures 
are performed: 
1. 
Demographics (Age and Gender) 
2. 
Gestational Age at Birth (for Neonates only) 
 
Added collection of age 
AND gestational age at 
birth for neonates only.  

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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81 
Section 9.4. Interim 
Analysis 
No interim analysis is planned. As necessary for study conduct, 
engineering, and/or regulatory purposes, study data may be accessed 
and, if necessary, reported by the Sponsor prior to closure of the 
study.  
 
Clarified that unplanned 
interim analyses may be 
conducted. 
82 
Footer 
DOC1466558, RevVersion 4.05.0 
 
Per current Sponsor 
documentation standards, 
the footer is updated to 
reflect the document 
“Version” rather than 
“Rev” (an internal IT 
system marker not 
synonymous with protocol 
revision/version). 
 
 
 
 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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APPENDIX E: AMENDMENT TO PROTOCOL VERSION 5.0  
Purpose: This amendment document describes in detail the changes made to the study protocol to 
reflect that both the DASH®4000 and CARESCAPE B650 may be equipped with GxP-validated tools 
designed to assist in research data capture. These tools are not intended for commercial release, and 
devices equipped with these tools will be used for investigational use only as described in this protocol. 
The addition of GxP tools for the CARESCAPE B650 (which were originally only available for DASH®4000 
as described in prior versions of this protocol) is intended to simplify data collection and reduce the 
frequency of errors or biases potentially encountered in manual data transcription from the study 
devices. 
 
The following amendments were made to version 5.0 to produce version 6.0. Point-by-point revisions 
are shown as additions in double-underline (double-underline) and deletions in strikethrough 
(strikethrough) for each change made in this amendment for the previous version. 
 
 
Item 
Section 
Revision or Clarification 
Justification 
83 
Abbreviations 
GEHC  
GE Healthcare 
GxP  
Good Processing Tools (validated research tools, 
not for commercial use) 
 
Added additional 
abbreviation definitions, 
as used in the body of the 
protocol. 
84 
Study synopsis: Device 
Description 
The control used in this study is gold standard aortic invasive 
blood pressure (IBP). Data may be collected on the DASH® 4000 
patient monitor equipped with the non-commercial GEHC DC-EDIT 
and GEHC DC-COLLECTOR GxP software that can be compared 
with data either manually collected from the NIBP CARESCAPE 
Monitor B650 monitor, or data may be collected using the GxP-
validated GEHC PDM Data Collection Module, which is capable of 
collecting electronic data typically displayed using patient 
monitorsd, which. The GxP-validated systems used in this study 
serve the sole function of enabling the device to directly output 
data such as blood pressure waveforms  data and parameters to 
the computerized data collection system (DCS) for storage and 
analysis purposes. 
Added additional 
information about the GxP 
processing tools used in 
the study. 
85 
Study Synopsis: Regulatory 
Status 
H® 4000 patient monitor (control system) equipped with GxP validated 
non-commercial DC-COLLECTOR and DC-Edit software programs 
for data collection is considered investigational. The acquisition 
modules PDM-SuperSTAT and PSM-Datex-Ohmeda with the PSM-
Datex-Ohmeda and PDM-SuperSTAT algorithms and used on the 
CARESCAPE Monitor B650 and accessories are commercially 
available. The PDM is  considered investigational when GxP-
validated PDM Data Collection Module is used, which functions in 
the same manner as the PDM but with additional ability to collect 
research data typically displayed on a patient monitor. Though 
pre- and post- market devices are utilized, all aspects of the study 
will be considered investigational. 
 
Added additional 
information about the GxP 
processing tools used in 
the study. 
86 
Section 2.3 Device Risk 
Analysis 
The NIBP measurement (PDM-SuperSTAT and PSM-Datex-
Ohmeda) devices and all patient monitors used in this study under 
Added additional 
information about the GxP 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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study are commercially available, and all devices will be used 
according to their labeling. The GxP-validated GEHC PDM Data 
Collection GxPModule software that enabledmay, when possible, 
be used to enable digital export of research data typically 
displayed on patient monitors., The GxP-validated GEHC PDM 
Data Collection module works in the same way as the 
commercially available PDM module, but also has software to 
enable digital export of the data for research use. The validated 
non-commercial DC-EDIT and DC-COLLECTOR equipment for the 
DASH® 4000 and GEHC PDM Data Collection Module  serves as a 
data output connections only and is are not expected to impact 
the clinical function of the device. Participation in this study is not 
expected to impact patient management, clinical diagnosis, or 
treatment strategy compared to that which would be determined 
by the standard of care outside of this study. 
 
processing tools used in 
the study. 
87 
Section 3.1.1.1. Patient 
Data Module (PDM) with 
DINAMAP® SuperSTAT 
Algorithm (PDM-
SUPSERSTAT) 
The Patient Data Module (PDM) is a high-acuity mobile 
hemodynamic acquisition module designed to help eliminate gaps 
and ECG resets when moving patients. The device can interface 
with the Solar® and CARESCAPE module patient monitors at the 
bedside and can quickly snap into and provide power for a 
Transport Pro® monitoring device. The detachable PDM docking 
station interfaces to the module frame flex board, and the 10-pin 
connector provides the VSYS ePort supply voltage and the 
Ethernet communication lines to the PDM module. The PDM 
includes GE’s clinical algorithms, including 12SL™ 12-lead ECG, 
12RL™ derived 12-lead ECG, GE EK-Pro four-lead arrhythmia 
analysis, GE DINAMAP® SuperSTAT non-invasive blood pressure, 
and Masimo® SET® or Nellcor® OxiMax® SpO2. PDM uses the 
DINAMAP® SuperSTAT NIBP measurement algorithm. 
The GxP-validated GEHC PDM Data Collection Module, which 
enables the digital collection of research data typically manually 
transcribed from the patient monitor may also be used in the 
procedure. The modified GEHC PDM Data Collection Module used 
the same technology as the commercial PDM module, but has 
additional GxP-validated data collection features that are 
intended for research use only (serving to minimize potential 
errors or biases due to manual transcription from the patient 
monitor) to allow data output.  This software program is not 
otherwise expected to produce any change in function of the 
commercially marketed patient module.   
 
Added additional 
information about the GxP 
processing tools used in 
the study. 
88 
Section 3.1.2.1. 
CARESCAPE Monitor B650 
The CARESCAPE Monitor B650 combines the strong clinical 
heritage of Datex-Ohmeda anesthesia and Marquette Electronics 
cardiac expertise, providing a significant level of backwards 
compatibility that allows hospitals to leverage prior technology 
and training.  
While the CARESCAPE Monitor B650 equipped with the DASH® 
4000 may be used in the study, use of these patient monitoring 
devices willmay not be required for procedures conducted using 
the GxP-validated GEHC PDM Data Collection Module, which 
enables the digital collection of research data typically manually 
transcribed from the patient monitor. The modified GEHC PDM 
Data Collection Module used the same technology as the 
Added additional 
information about the GxP 
processing tools used in 
the study. 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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commercial PDM module, but has additional GxP-validated data 
collection features that are intended for research use only (serving 
to minimize potential errors or biases due to manual transcription 
from the patient monitor).   
 
89 
Section 3.2. Regulatory 
Status 
The PSM and PDM acquisition modules and CARESCAPE B650 used 
in this study are commercialized in the United States and have 
been cleared by the US FDA. Because the PSM module is not 
currently cleared for using in neonates or infants under 5 kg 
(approximately 11 lbs.), no patients in this age range will be 
examined with PSM in this study. The PDM device is cleared for 
use in patients of all ages. When possible, sites may also use the 
modified GxP-validated GEHC PDM Data Collection module, which 
uses the same technology as the commercially available PDM 
module with additional features to enable digital collection of 
research data. The GxP-validated PDM Data Collection Module is 
considered a pre-market device used for research purposes only, 
and is not intended to be commercialized.  
The DASH® 4000 patient monitors are commercialized; however, 
when the Good Processing Tools (GXPGxP) validated DC-EDIT and 
DC-COLLECTOR are equipped on the DASH®4000 the device is 
considered non-commercial (investigational) and is to be used for 
research purposes only. Notably, DC-EDIT and DC-COLLECTOR 
have been validated for use in clinical data collection for the 
purpose of regulatory submissions. The results of the current 
study may be used as part of regulatory submissions to the US 
FDA or other global regulatory bodies to support the use of the 
investigational NIBP software algorithms with other patient 
monitoring systems. 
 
Added additional 
information about the GxP 
processing tools used in 
the study. 
90 
Section 3.3. Risk 
Category/Rationale (US 
Only) 
The CARESCAPE Monitor B650, acquisition modules (PDM and 
PSM), and peripheral cuffs and hoses used in this study are 
cleared for commercial use and will be used as intended in their 
labeling. All commercial devices are considered to be IDE Exempt 
per 21 CFR 812.2(c)(2).  The DASH® 4000 is a commercial device; 
however, when equipped with the GxP validated non-commercial 
DC-EDIT and DC-COLLECTOR tools for data output it is to be used 
for research purposes only. Similarly, the GxP-validated PDM Data 
Collection Module used in place of manual transcription from 
patient monitors is intended for research use only.  DC-EDIT and 
DC-COLLECTOR (for DASH®4000) as well as the PDM Data 
Collection Module  tools are not expected to impact the function 
of the DASH® 4000 deviceof other devices or the integrity of the 
study, but instead are intended solely to enable digital collection 
of study data while minimizing biases associated with manual 
transcription of data. When equipped withusing a DASH® 4000 
equipped with DC-EDIT and DC-COLLECTOR, the DASH® 4000 or 
the PDM Data Collection Module in place of manual data 
transcription from patient monitors, the  and devices algorithms 
investigated in this research study are considered a non-significant 
risk devices per the 21 CFR 812.3 definition: 
 
Added additional 
information about the GxP 
processing tools used in 
the study. 
91 
Section 3.4. 
Device/Product 
The PSM acquisition module (using Datex-Ohmeda GE for NIBP 
assessment) is cleared for commercial use under US FDA 510(k) 
Added additional 
information about the GxP 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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Classification and 
Rationale 
K062576 (2006), and the PDM acquisition module (using 
DINAMAP® SuperSTAT for NIBP assessment) is cleared for 
commercial use under US FDA 510(k) K071073 (2007) as a non-
invasive blood pressure measurement system (DXN) under CFR 
870.1130. 
When available, the pre-market PDM Data Collection GxP Module 
may be used in place of manual transcription from patient 
monitors using the commercial PDM module, enabling research 
data to be collected digitally. The PDM Data Collection GxP 
Module has been qualified per Good Processing Tools (GxP) by GE 
Healthcare for collection of ECG, and blood pressurearterial data 
in clinical settings, settings (GEHC Internal Book Numbers 
DOCXXXXXXX and DOCXXXXXXX), and is considered investigational 
and intended for research use only. 
The CARESCAPE Monitor B650 is a Class II medical device classified 
as a Patient Physiological Monitor (with arrhythmia detection or 
alarms) by the US FDA and cleared under 510(k) K131223 (2013). 
The most recent FDA cleared software version for the CARESCAPE 
Monitor B650 at the time of the study will be used on the 
CARESCAPE Monitor B650. 
 
The DASH® 4000 patient monitor is a Class II medical device 
classified as a Patient Physiological Monitor by the US FDA and 
cleared under 510(k) K073462 (2008). Non-commercial DC-EDIT 
and DC-COLLECTOR tools used on the DASH®4000 have been 
qualified per Good Processing Tools (GXPGxP) by GE Healthcare 
for collection of ECG and arterial data in clinical settings (GEHC 
Internal Book Numbers DOC0610288 and DOC0609984). When 
equipped with these tools, the DASH® 4000 patient monitor will 
be considered investigational. 
 
processing tools used in 
the study. 
Corrects/removed 
outdated DOC references. 
92 
Section 3.5. 
Device/Product Issuance 
and Replacement 
• PSM and PDM acquisition modules for the CARESCAPE Monitor 
B650 with appropriate software versions already installed, or, 
based on availability, the PDM Data Collection Module  labeled as 
investigational (for research purposes only). 
 
Added additional 
information about the GxP 
processing tools used in 
the study. 
93 
Section 6.3. Number of 
Subjects 
5. PSM-Datex-Ohmeda Arm (NPSM): 2938 evaluable patients with 
Datex-Ohmeda algorithm (PSM module) on CARESCAPE Monitor 
B650, to achieve a total of ≥150 BP data pairs in patients ≥3 years 
old (up to 10 paired measurements per subject) and ≥150 BP data 
pairs in patients <3 years old (as described in Table 2). 
[correction is also reflected in Table 1] 
Corrects typographical 
error in number of 
subjects. This correction is 
also reflected in Table 1. 
94 
Section 7.1.1. IBP Data 
Collection on the Data 
Collection System (DCS) 
The PDM Data Collection Module may be used to collect research 
data (based on availability) for PDM procedures, else IBP and ECG 
data will be collected using a DASH® 4000 patient monitor with 
the hardware and software tools to connect to a computerized 
data collection system (DCS) housed on a Sponsor-provided laptop 
computer. One A DCS (laptop)laptop will be connected for 
electronic data capture, when GxP-validated data capture tools 
are used to the DASH® 4000 via a serial cable from the DASH to 
the DCS laptop. The investigator is responsible for setting up the 
DCS for data collection of IBP data according to the “Setup of Data 
Collection” section of the Device Set-Up Manual provided by the 
Sponsor. For applicable procedures, theThe control panel for the 
Added additional 
information about the GxP 
processing tools used in 
the study, which utilize the 
DCS system to collect 
additional data compared 
to the previous GxP tool. 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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Justification 
DASH® 4000 patient monitor is shown in the “DASH® 4000 Control 
Panel” section of the section of the Device Set-Up Manual 
provided by the Sponsor, which provides details on user setup and 
operation of the DASH® 4000 patient monitor. 
The patient procedure for IBP setup is shown in the “IBP Setup” 
section of the Device Set-Up Manual provided by the Sponsor. 
Similarly, the Device Set-Up Manual provides instructions for 
setup and use of the PDM Data Collection Module for electronic 
data capture during PDM procedures. 
 
95 
Section 7.1.2. NIBP Data 
Collection 
NIBP will be recorded on a commercial CARESCAPE Monitor B650 
with most recent commercial software version installed. NIBP data 
will be transcribed by hand from the display of the CARESCAPE 
B650 monitor onto the Sponsor-provided Case Report Form (CRF) 
when the PDM Data Collection Module is not available. When the 
PDM Data Collection Module is available, data collection may be 
performed electronically using this tool. 
For patients in the PDM-SuperSTAT arm of the study, NIBP will be 
measured with a CARESCAPE Monitor B650 equipped with a PDM 
acquisition module or the GxP PDM Data Collection Module. For 
patients in the PSM-Datex-Ohmeda arm of the study, NIBP will be 
measured with a CARESCAPE Monitor B650 equipped with a PSM 
acquisition module.  
 
Added additional 
information about the GxP 
processing tools used in 
the study. 
96 
Section 7.2.2. Before the 
Procedure 
For each patient, the following procedure-specific information will 
be recorded on CRFs: 
Model and serial number for the DASH® 4000 (if applicable)  
Model and serial number for CARESCAPE B650 (if applicable)  
Model and serial number for the PSM or PDM acquisition module 
used 
Catheter cross-section, length, and trade name 
Trade name of pressure transducer 
Site/artery used for IBP measurements 
Monitor filter settings and recording settings, if applicable 
Identification of the observer making the recordings (name and 
position) 
Details of any special circumstances during measurement 
Pulse rate at the start of device evaluations 
Time and date of last manometer calibration 
Three ECG sensors will be placed with leads on the left and right 
arm and left leg connected to the DASH® 4000 or the PDM Data 
Collection Module.  
 
Corrected applicability of 
data collection elements. 
97 
Section 7.2.4. Blood 
Pressure Assessments 
NIBP will be measured using the CARESCAPE Monitor B650 patient 
monitor equipped with an acquisition module (either PDM-
SuperSTAT or PSM-Datex-Ohmeda, determined by study arm). For 
PDM procedures where the PDM Data Collection Module is used 
for electronic data capture, this may be used in place of manual 
transcription from the patient monitor to paper CRFs. IBP will be 
measured using the DASH® 4000 plus DC-COLLECTOR and DC-EDIT 
software. For PDM procedures where the PDM Data Collection 
Module is used for electronic data capture, this may be used in 
place of manual transcription from the patient monitor to paper 
Clarified use of the PDM 
data collection module. 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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CRFs. During the blood pressure assessments, values will be 
recorded for: 
… 
Both NIBP and IBP assessments will be conducted simultaneously, 
with IBP data collected on the DCS and NIBP datausing either 
digital data recording tools (when available) or recorded by hand 
onto a paper Case Report Form (CRF). If necessary, assistance will 
be provided by other study staff to ensure that accurate and 
simultaneous blood pressure data is recorded. 
IBP data will be continuously collected throughout the study.  
For cases where manual data collection of and NIBP data is 
necessary, it  will be recorded according to the following 
procedure: 
… 
When all NIBP measurements are complete, stop the IBP data 
collection. 
For PDM procedures where the PDM Data Collection Module is 
used, data may be captured electronically instead of using the 
manual procedure according to the following procedure: 
1. 
Use the PDM Data Collection Module to determine the 
patient's blood pressure. 
2. 
Wait at least 3 min. 
3. 
Simultaneously record and determine the patient's blood 
pressure, as follows. 
4. 
Start NIBP measurement from the PDM Data Collection 
Module 
5. 
Wait the appropriate amount of time between determinations 
(as defined in Table 2). 
6. 
Repeat steps 3 and 4 adhering to the requirements in Table 2 
until the target number of recordings and determinations 
have been performed or the subject leaves the study. In the 
event that any blood pressure determination is not successful, 
the procedure may be repeated to achieve the target number 
of successful blood pressure determinations. No more than 
the maximal number of total blood pressure determinations 
as specified in Table 2 will be performed on any patient. 
7. 
When all NIBP measurements are complete, stop the data 
collection. 
 
For PDM procedures where the PDM Data Collection Module is 
used, data may be captured electronically instead of using the 
manual procedure. In this case, the user should conduct each 
determination using the laptop-based interface for the PDM Data 
Collection Module. After all determinations are completed using 
the laptop-based interface for the PDM Data Collection Module, 
the user should ensure that the files are stored and labeled as 
described in the Device Set-Up Manual. 
The same number and type of determination should be performed 
whether the manual or digital PDM Data Collection Module is 
used. 
 
 
98 
Section 7.3. Data Storage 
All digitally recorded IBP data from the DCS will be saved from the 
DCS folder to a Sponsor-provided external media (e.g., flash drive 
Clarified that using the 
new GxP module data 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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or CD), and the Investigator will confirm that all data is saved on 
flash drive or CD and stored in a secured area at the 
investigational site. When NIBP data will be  is recorded on paper 
case report forms, it will be stored in a secure area at the 
investigational sites.  
 
collection is not limited to 
IBP using the DCS. 
99 
Section 9.2. Determining 
Reference Invasive Blood 
Pressure Per ISO 81060-
2:2013 
First, the mean and the standard deviation of the invasive blood 
pressures derived from the IBP wave recordings during a NIBP 
determination will be calculated; and the range of reference 
invasive blood pressure will be determined as mean ±1 standard 
deviation (SD) of the IBPs. The same method will be used for both 
systolic and diastolic blood pressures. Calculation of reference IBP 
from IBP wave recordings is not part of the statistical analysis. All 
data from a subject will beData may be excluded for analysis, 
when the range of invasive systolic BP is wider than 20 mmHg or 
when the range of invasive diastolic BP is wider than 12 mmHg, as 
such that analysis is performed in accordance with or as specified 
per ISO 81060-2:2013. 
 
Clarified that analysis 
(including exclusion of 
some data) will be 
performed as detailed in 
ISO 81060-2-2013. 
100 
Section 9.3.1. Data 
Exclusion 
• NIBP data from a subject if the range of reference systolic blood 
pressure is more than 20mmHg or the range of reference diastolic 
blood pressure is more than 12 mm Hg, or as specified per ISO 
81060-2:2013 standard; 
 
Clarified that analysis 
(including ranges of data) 
will be performed as 
detailed in ISO 81060-2-
2013. 
101 
Section 13.4. Informed 
Consent and Privacy 
Requirements 
Informed consent will be documented in the source record of 
each subject. The Investigator or designee will consent the subject 
per regulatory guidelines which include that the subject has ample 
time to review the ICF and have all questions answered to their 
satisfaction; the subject may take the ICF home to review with 
family members or others prior to agreeing to participate in the 
study; upon agreeing to participate in the study, the subject signs 
and dates the document, and the person who consented the 
subject signs and dates the document.   
Minor subjects are legally unable to provide informed consent. 
Therefore these study participants are dependent on their 
parent(s) or legal guardian to assume responsibility for their 
participation in clinical studies. Fully informed consent will be 
obtained from the legal guardian in accordance with applicable 
laws and regulations. All participants will be informed to the 
fullest extent possible about the study in language and terms they 
are able to understand. 
 
Corrected typographical 
error. 
102 
Section 14.3. Completion 
of Case Report Forms 
(CRFs) 
Data will be collected using paper CRFs and data collection system 
(DCS) data per the details of this protocol. 
 
Corrected typographical 
error. 
 
 
 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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APPENDIX F: AMENDMENT TO PROTOCOL VERSION 6.0  
Purpose: This amendment document describes in detail the changes made to the study protocol to 
clarify that subjects with radial lines are eligible to participate., in addition to the existing routes 
(umbilical and femoral) already specified in the protocol. All catheterization lines will be places as 
clinically indicated, and will not be altered for study purposes. 
 
The following amendments were made to version 5.0 to produce version 6.0. Point-by-point revisions 
are shown as additions in double-underline (double-underline) and deletions in strikethrough 
(strikethrough) for each change made in this amendment for the previous version. 
 
 
Item 
Section 
Revision or Clarification 
Justification 
103 
Section 2.3.1 Risk Analysis 
for Subjects with 
Indwelling Lines (≤29 days 
of age) 
Eligible subjects aged 29 days or less will be recruited only if they 
currently have, or are scheduled to have, an indwelling femoral, radial, 
or umbilical arterial monitoring line placed. The type of line places will 
be determined according to the site standard of care, and not altered 
based on participation in the study. While radial lines are the most 
commonly placed indwelling lines in neonates, femoral and umbilical 
lines share a similar safety profile and, in some cases, are preferred in 
order to preserve integrity of vessels when future interventions may 
be required.15 Like radial and femoral line placements, umbilical lines 
have, which has been shown to have a minimal complication rate even 
during longer procedures when performed by experienced 
physicians.5,15  For these subjects, NIBP measurements will be 
 
Clarified that subjects with 
radial lines are eligible to 
participate. 
 
Notably, the type of 
indwelling line places is 
determined according to 
the standard of care and 
not influences by study 
participation. 
 
Added additional citation 
#15 to support the safety 
profile of radial lines. 
104 
Section 6.1 Subject 
Population 
The study will include neonates with indwelling femoral, radial, or 
umbilical arterial monitoring lines and infant, pediatric, adolescent, 
and adult subjects requiring non-emergent surgery involving aortic 
catheterization (including chronic atrial fibrillation patients among 
adults and adolescents). 
 
Clarified that subjects with 
radial lines are eligible to 
participate. 
 
105 
Section 6.4 Inclusion 
Criteria 
1. 
Are aged >29 days requiring clinically indicated non-
emergent heart catheterization OR aged ≤29 days with 
placed or scheduled placement of an indwelling femoral, 
radial, or umbilical arterial monitoring line; 
 
Clarified that subjects with 
radial lines are eligible to 
participate. 
 
106 
Section 11.4 Management 
of Serious Adverse Event 
and Unanticipated Adverse 
Device Effect Reporting 
All SAEs and or UADEs will be documented as above and reported in 
writing to the Sponsor within 72 hours of knowledge of the event   The 
Investigator shall submit the Adverse Event Case Report Form and 
GEHC_GQP_10.07.005_F002 Site Notification and Assessment of 
Serious and Unexpected Adverse Events (DOC0910335) with redacted 
supporting documentation to SAE mailbox. If the event resulted in the 
death of a subject, the event shall also be reported via telephone to 
the Sponsor within 24 hours of knowledge of the event. SAEs will be 
reported to the local EC/IRB per their policy.  
Removed redundant 
duplicate entry of the 
Medical Monitor’s contact 
information, per Sponsor’s 
internal best practices and 
templates. The contact 
information for the 
medical monitor is 
unchanged, and still 
remains in the early part 

Study Title: Measurement of NonInvasive Blood Pressure with DINAMAP 
SuperSTAT and Datex-Ohmeda  with Intra-arterial Blood Pressure in Neonates 
through Adults and Special Populations  (MISSION Trial) 
Study Number: 123.04-2013-GES-0008 
Protocol: 7.0 
 
 
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The Sponsor’s Medical Monitor (complete contact information listed 
in the Study Synopsis) should be contacted for SAEs and/or UADEs: 
Helena Haukilehto, MD  
Telephone: +358-103943609 
Email: 
helena.haukilehto@ge.com 
Fax: 800-888-3983 
E-mail: SAE@ge.com 
 
of the protocol “study 
synopsis” section. 
107 
References 
15. Sabourdin N, Louvet N, Constant I. Selection of Anesthesia 
Techniques for the Neonate. In: Lerman J, ed. Neonatal Anesthesia. 
New York, NY: Springer; 2014. 
Added additional citation 
#15 to support the safety 
profile of radial lines. 
 
 
End of Document