Clinical Evaluation of the CM-1500 During Apheresis Blood Donation
Phase: NA
Conditions: Fluid Loss
Sponsor: Zynex Monitoring Solutions

 
 
 
 
 
Clinical Evaluation of the CM Device During Apheresis Blood Donation 
NCT05012462 
28-FEB-2022 
 
 
 

 
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CLINICAL PROTOCOL 
 
 
TITLE 
 
Clinical Evaluation of the CM Device During Apheresis Blood 
Donation 
 
PROTOCOL 
ZMS-1500-2021-Apheresis 
 
SPONSOR 
Zynex Monitoring Solutions (ZMS) 
9555 Maroon Circle 
Englewood, CO 80112 
 
PROTOCOL VERSION 
2.0 
 
 
DOCUMENT REVIEW  
& APPROVAL 
 
 
 
 
 
 
Sponsor Representative: 
 
 
 
 
 
 
Donald Gregg 
VP, Zynex Monitoring Solutions 
 
 
Sponsor Representative: 
 
Signature 
 
Date 
Laura Seiberlich 
Zynex Clinical Affairs 
 
Signature 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CONFIDENTIALITY STATEMENT 
This document is the confidential information of Zynex. It is provided to you as an investigator or 
consultant for review by you, your personnel, and the applicable Institutional Review Board/. Your 
acceptance of this document constitutes an agreement that you cannot disclose the information 
contained herein to others without the prior written consent of Zynex. 
 
 

 
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PROTOCOL SIGNATURE PAGE 
 
TITLE 
Clinical Evaluation of the CM Device During Apheresis Blood 
Donation 
PROTOCOL 
ZMS-1500-2021-Apheresis 
SPONSOR 
Zynex Monitoring Solutions (ZMS) 
9655 Maroon Circle 
Englewood, CO 80112 
 
PROTOCOL VERSION 
2.0 
 
 
The signature below constitutes I have read, understood, and the approve this protocol and provide 
assurances that this trial will be conducted according to all stipulations of the protocol, including all 
statements regarding subject confidentiality, and according to local legal and regulatory requirements, 
including all applicable U.S. federal and local regulations and ICH guidelines. 
 
I agree to supervise all testing of the device involving human subjects. I confirm I will ensure Informed 
Consent requirements will be met for all subjects. I confirm I will ensure Informed Consent of each 
subject is obtained before any study procedures; protect the rights, safety, and welfare of all study 
subjects; prepare and maintain accurate, current, and complete records (including Adverse Events); 
provide timely reports to the Sponsor; ensure changes are not implemented without prospective IRB 
approval unless required to eliminate an immediate hazard to subjects; retain records as set out in the 
protocol; disclose relevant financial information. 
 
 
 
 
Principal Investigator (PI): 
 
 
 
PI Printed Name 
 
 
 
 
 
 
 
PI Signature 
 
 
 
 
 
 
 
 
Date (DD-MMM-YYYY) 
 
 
CONFIDENTIALITY STATEMENT 
This document is the confidential information of Zynex. It is provided to you as an investigator or 
consultant for review by you, your personnel, and the applicable Institutional Review Board/Ethics 
Committee. Your acceptance of this document constitutes an agreement that you cannot disclose the 
information contained herein to others without the prior written consent of Zynex. 
 
 
 

 
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PROTOCOL AMENDMENT HISTORY 
 
Version 
Number 
Description of Change(s) 
Reason for Change 
1.0 
Initial protocol; no changes 
N/A 
2.0 
Revise protocol to include the CM-1600 
Collect study data using the latest CM 
device that wasn’t previously available 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[This space is intentionally left blank] 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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TABLE OF CONTENTS 
1 
INTRODUCTION ................................................................................................................................ 8 
1.1 
CLINICAL RATIONALE ............................................................................................................. 9 
2 
INVESTIGATIONAL PLAN .............................................................................................................. 9 
2.1 
OBJECTIVES .............................................................................................................................. 9 
2.2 
STUDY DURATION ................................................................................................................... 9 
2.3 
STUDY DESIGN ......................................................................................................................... 9 
3 
STUDY DEVICE ............................................................................................................................... 10 
3.1 
CARDIAC MONITOR, MODEL 1500 (CM-1500) ................................................................ 10 
3.1.1 
DEVICE DESIGN AND COMPONENTS ...................................................................... 10 
3.1.2 
PRINCIPLES OF OPERATION ...................................................................................... 10 
3.1.3 
INDICATIONS FOR USE ................................................................................................ 10 
3.1.4 
INTENDED USE ............................................................................................................... 10 
3.2 
CARDIAC MONITOR, MODEL 1600 (CM-1600) ................................................................ 11 
3.2.1 
DEVICE DESIGN AND COMPONENTS ...................................................................... 11 
3.2.2 
PRINCIPLES OF OPERATION ...................................................................................... 11 
3.2.3 
INDICATIONS FOR USE ................................................................................................ 11 
4 
SUBJECT POPULATION AND SELECTION ............................................................................. 11 
4.1 
POPULATION AND ANTICIPATED NUMBER OF SUBJECTS ....................................... 11 
4.2 
SUBJECT INCLUSION CRITERIA ........................................................................................ 11 
4.3 
SUBJECT EXCLUSION CRITERIA ...................................................................................... 12 
4.4 
SUBJECT WITHDRAW / EARLY TERMINATION .............................................................. 12 
5 
STUDY PROCEDURES .................................................................................................................. 12 
5.1 
ENROLLMENT ......................................................................................................................... 12 
5.1.1 
INFORMED CONSENT ................................................................................................... 12 
5.2 
BASELINE DATA ..................................................................................................................... 13 
5.3 
STUDY PROCEDURE ............................................................................................................ 13 
5.3.1 
PREPARING DEVICE FOR OPERATION ................................................................... 13 
5.3.2 
CM DEVICE MONITORING SESSION......................................................................... 13 
5.4 
ADVERSE EVENTS ................................................................................................................ 14 
5.5 
SUBJECT COMPLETION ....................................................................................................... 14 

 
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6 
DEVICE MANAGEMENT................................................................................................................ 14 
6.1 
UNPACKING AND INSPECTION .......................................................................................... 14 
6.2 
ACCOUNTABILITY, STORAGE & DISPENSATION .......................................................... 15 
6.3 
CLEANING & RETURN ........................................................................................................... 15 
7 
RISKS & BENEFITS ....................................................................................................................... 15 
7.1 
RISK DETERMINTATION & REDUCTION .......................................................................... 15 
7.2 
BENEFITS ................................................................................................................................. 15 
8 
SAFETY ASSESSMENT AND MANAGEMENT ........................................................................ 16 
8.1 
SAFETY DEFINITIONS ........................................................................................................... 16 
8.1.1 
ADVERSE EVENT (AE) .................................................................................................. 16 
8.1.2 
SERIOUS ADVERSE EVENT (SAE) ............................................................................ 17 
8.1.3 
UNANTICIPATED ADVERSE DEVICE EFFECT (UADE) ......................................... 17 
8.2 
SAFETY REPORTING ............................................................................................................ 17 
8.2.1 
REPORTING EVENTS & SAFETY CONTACTS ........................................................ 18 
9 
STATISTICAL METHODS AND CONSIDERATIONS ............................................................... 18 
9.1 
SAMPLE SIZE DETERMINATION ........................................................................................ 18 
9.2 
ANALYSIS SET ........................................................................................................................ 19 
9.3 
DESCIPTIVE STATISTICS ..................................................................................................... 19 
9.4 
DEMOGRAPHIC AND BASELINE CHARACTERISTICS ................................................. 19 
9.5 
STATISTICAL ANALYSIS ....................................................................................................... 19 
10 
DATA COLLECTION, RETENTION, AND MONITORING ................................................... 20 
10.1 
DATA COLLECTION ............................................................................................................... 20 
10.1.1 
SUBJECT CONFIDENTIALITY ...................................................................................... 20 
10.2 
DATA RETENTION .................................................................................................................. 20 
10.3 
MONITORING ........................................................................................................................... 21 
10.3.1 
MONITORING PLAN ....................................................................................................... 21 
11 
STUDY ADMINISTRATION ....................................................................................................... 21 
11.1 
AUDITS AND INSPECTIONS ................................................................................................ 21 
11.2 
PROTOCOL AND ICF AMENDMENTS ................................................................................ 21 
11.3 
PROTOCOL DEVIATIONS ..................................................................................................... 21 
12 
ETHICAL AND OTHER REGULATORY CONSIDERATIONS ............................................ 21 

 
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12.1 
INSTITUTIONAL REVIEW BOARD (IRB) REVIEW ........................................................... 21 
12.2 
WRITTEN INFORMED CONSENT ....................................................................................... 22 
12.3 
REFERENCES ......................................................................................................................... 23 
13 
ABBREVIATIONS AND DEFINITIONS OF TERMS .............................................................. 24 
 
FIGURES AND TABLES 
Figure 1: Study Procedure Overview .........................................................................................12 
 
Table 1: Adverse Event Severity Grading ..................................................................................16 
Table 2: Adverse Events Action(s) Taken .................................................................................16 
Table 3: Adverse Event Relationship to Donation or Study Procedure ......................................16 
Table 4: Adverse Event Outcome..............................................................................................17 
Table 5: Study Reporting Contacts ............................................................................................18 
Table 6: Abbreviations and Definition of Terms .........................................................................24 
 
 
 

 
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1 
INTRODUCTION 
Intraoperative and postoperative hemorrhage incidence can vary depending on the type of 
surgery and can lead to severe clinical complications ranging from mild anemia to fatal 
hemorrhagic shock. Those that recover from severe hemorrhagic events often have poor 
functional outcomes and are at risk for greater long-term mortality. Numerous studies reveal that 
post-operative hemorrhagic events are also quite frequent, occurring in as many as 13 to 19% 
of patients following various type of surgeries (i.e., major pancreatic resections, transoral robotic 
surgery (TORS) for oropharyngeal squamous cell carcinoma, and living-donor transplants). 
Hemorrhagic shock is also a leading cause of death in trauma.1-6   
Monitoring and detecting fluid changes in patients can be complicated. Physiological responses 
associated with hemorrhagic events are often delayed because of compensation mechanisms 
that act to sustain blood pressure and protect tissue perfusion.1 The ability to continuously and 
non-invasively detect changes in central blood volume and blood loss will permit appropriate 
hemodynamic management during events at high risk for acute blood loss such as surgery, 
trauma, post-operative care and other therapeutic procedures.  Through early detection and 
improved hemodynamic monitoring, optimization of fluid balance, anesthesia titration, and 
augmenting other acute care management requirements, a clinician should be able to improve 
overall patient stability, minimize complications, diminish surgical trauma and reduce recovery 
time. 
Current methods for acutely monitoring blood volume and blood loss include monitoring of vital 
signs (such as heart rate, blood pressure respirations, and oxygen saturation), invasive central 
venous (right heart central venous pressure measurement and swan ganz pulmonary capillary 
wedge pressure measurements) and arterial catheters designed to monitor hemodynamic status 
centrally.  Vital sign monitoring may not indicate small amounts of acute blood loss and arterial 
and venous cannulations can create insertion complications such as perforations in the 
vasculature, pneumothorax, arrhythmias, thrombosis and infection.  While invasive central 
monitoring may provide extremely accurate information, changes may not be good indicators of 
early central hypovolemia or with smaller blood volume reductions1-2.   
The Zynex Cardiac Monitor (CM) Device, uses a relative patient standard approach by non-
invasively and simultaneously monitoring five (5) physiological parameters, including 
bioelectrical impedance, ECG amplitude, photoplethysmogram (PPG) amplitude, heart rate, and 
skin temperature. The CM Device starts by creating a baseline for each patient in a normal 
state. When the monitoring session starts, each patient starts with a Relative Index of 100, 
signifying the collection of parameters near their original baseline value(s). The Relative Index 
value acts as a combinational score for all the parameters indicative of relative fluid change.  
There are two (2) models of the CM Device, Model 1500 (CM-1500) and 1600 (CM-1600) which 
measure the same five (5) parameters and utilize the same algorithm to output the Relative 
Index value.   

 
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1.1 
CLINICAL RATIONALE 
The proposed clinical study is designed to confirm that the Zynex non-invasive monitoring 
device can track blood volume changes in healthy individuals consented to undergo an 
apheresis blood donation.  An initial feasibility was conducted (n = 12 subjects) to confirm that 
the CM-1500 can be used to track acute blood loss in healthy individuals donating 500mL of 
blood.  Additional research is required to validate the sensitivity and specificity of the CM Device 
to tracking blood loss and blood volume changes during an apheresis blood donation as well as 
establish the changes in the RI with loss of different blood components.    
2 
INVESTIGATIONAL PLAN 
2.1 
OBJECTIVES 
The primary objective of the study is to characterize changes in the CM Device Relative Index 
during an apheresis procedure.   
The secondary objectives of the study are to characterize the following: 
• 
Changes in blood pressure relative to changes in the Relative Index  
• 
Relative Index changes when using Trima or Amicus apheresis devices 
• 
CM Device’s ability to detect different blood components and fluid 
2.2 
STUDY DURATION 
Enrollment in the study is expected to take up to 12 months, and data analysis may take up to 
an additional 2 months to complete.  
2.3 
STUDY DESIGN 
The study is a prospective, single-arm, non-randomized, non-blinded, non-controlled, non-
significant risk, single center study enrolling up to 200 healthy adult subjects consented to 
undergo an apheresis donation procedure. The study will be enrolled in two (2) phases.  The first 
phase will include 25 subjects consented to any automated blood component device procedure 
at the study site.   
At the end of the first phase of 25 subjects, the CM-1500 data will be evaluated to determine if 
sufficient Relative Index changes can be detected during an apheresis procedure to warrant 
continuing study enrollment and assess the potential need to sub-select a specific population of 
apheresis procedure(s) to optimize the ability of the CM Device to track the fluid changes in the 
subjects.  For example, it’s possible that certain apheresis procedures (e.g. platelet donation) may 
provide greater opportunity for detection of fluid changes than others. The Sponsor will 
communicate the decision with the study site, and if determined appropriate, enrollments will 
continue as communicated up to a maximum of 200 subjects.  
Note: Any significant changes to the study protocol (and subsequent consent) that are required 
after the analysis of the first phase of 25 subjects will require IRB approval prior to continuing with 
the remaining study enrollments.    

 
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3 
STUDY DEVICE  
3.1 
CARDIAC MONITOR, MODEL 1500 (CM-1500)  
The CM-1500 is a U.S. Food and Drug Administration (FDA) cleared non-invasive monitoring 
device that simultaneously monitors five (5) parameters of a patient’s body. Parameters include 
bioelectrical impedance, heart rate, ECG amplitude, PPG amplitude, and skin temperature. A 
combination of these parameters is represented by a single number known as the Relative Index 
value. This value is indicative of relative changes in fluid volume. The Relative Index is a unique 
functionality of the Zynex Cardiac Monitoring Device. 
3.1.1 DEVICE DESIGN AND COMPONENTS 
The CM-1500 is an all-inclusive device that includes the following components: display monitor 
(1), power supply (1), trunk cable (1), wrist cuff with attached PPG finger glove (1), wrist strap (1), 
and electrode array set (2). The wrist cuff with attached PPG finger glove may be cleaned and 
reused. The wrist strap is single-subject use. The electrode array sets are single-use, single-
subject. 
3.1.2 PRINCIPLES OF OPERATION 
The CM-1500 measures bioelectrical impedance (ohms), heart rate (BPM), ECG amplitude, PPG 
amplitude, and skin temperature (◦C or ◦F). As parameters change, towards indications of fluid 
change/imbalance, the Relative Index, which acts as a combinational score of percent change 
values for all of the parameters, will compound these changes into a singular value to signify 
overall fluid changes/imbalances within the patient’s body. When the monitoring session starts, 
every patient will start with a Relative Index of 100, signifying the combination of physiological 
parameters is near or at their original baseline values for all five monitored parameters. All 
parameters are continuously measured and tracked during a monitoring session. ECG and PPG 
amplitude values are only visible on the Advanced monitoring session display mode, as selected 
in the Setup screen. 
3.1.3 INDICATIONS FOR USE 
Per the device’s FDA clearance, the CM-1500 is indicated for monitoring bioelectrical impedance, 
heart rate, ECG amplitude, and PPG amplitude and their relative changes, indicative of relative 
changes in fluid volume in adult patients. 
3.1.4 INTENDED USE 
Per the device’s FDA clearance, the CM-1500 is intended to be used in professional medical 
environments, i.e., hospitals, clinics, and research institutions. The CM-1500 is a standalone 
device intended for desktop use, where device operation is to be performed as uninterrupted 
patient monitoring. The CM-1500 shall only be used by a qualified device operator. The operator 
shall have knowledge of the system and data interpretation obtained via medical education, 
system documentation, and specific courses. The device does not report any diagnosis but 
provides numerical values; it is ultimately the physician’s responsibility to make proper diagnosis 
and judgments based on these values. 

 
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3.2 CARDIAC MONITOR, MODEL 1600 (CM-1600)  
The CM-1600 is a non-invasive monitoring device predicated by the CM-1500 that simultaneously 
monitors the same five (5) parameters of a patient’s body and represents a combination of these 
parameters as a single Relative Index. The device has been submitted for 510(k) approval from 
the FDA, but since it has not yet received clearance, it will be labeled as a non-significant risk 
investigational device when used in the study.  
3.2.1 DEVICE DESIGN AND COMPONENTS 
The CM-1600 is an all-inclusive device that includes the following components: display monitor 
(1), power supply (1), wrist wearable (1), and electrode array set (2). The wrist wearable may be 
cleaned and reused. The electrode array sets are single-use, single-subject. 
3.2.2 PRINCIPLES OF OPERATION 
The principles of operation for the CM-1600 are the same as the CM-1500.  
3.2.3 INDICATIONS FOR USE  
Per the device’s FDA 510(k) submission, the CM-1600 is indicated for monitoring bioelectrical 
impedance, heart rate, ECG amplitude, and PPG amplitude and their relative changes, indicative 
of relative changes in fluid volume in adult patients. 
3.2.4     INTENDED USE 
Per the device’s FDA 510(k) submission, the CM-1600 is intended to be used in professional 
medical environments, i.e., hospitals, clinics, and research institutions. The CM-1600 is a 
standalone device intended for desktop use, where device operation is to be performed as 
uninterrupted patient monitoring. The CM-1600 shall only be used by a qualified device operator. 
The operator shall have knowledge of the system and data interpretation obtained via medical 
education, system documentation, and specific courses. The device does not report any diagnosis 
but provides numerical values; it is ultimately the physician’s responsibility to make proper 
diagnosis and judgments based on these values. 
 
4 
SUBJECT POPULATION AND SELECTION 
4.1 
POPULATION AND ANTICIPATED NUMBER OF SUBJECTS 
Up to 200 healthy adult subjects who meet the inclusion and exclusion criteria will be 
consecutively enrolled in the study. Subjects will be enrolled in 2 phases.  Phase 1 will include 25 
subjects and phase 2 will consist of the remaining 175 subjects.  Subjects who enroll in the study 
but withdraw before using the device will not be included in the total number of subjects and will 
be replaced. 
4.2 
SUBJECT INCLUSION CRITERIA 
I.1 
Ability to provide written informed consent 
I.2 
Ability and willingness to comply with the study procedures and duration 
requirements 

 
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I.3 
18 years of age or older 
I.4 
Consented to undergo an apheresis procedure with an automated blood 
component device 
4.3 
SUBJECT EXCLUSION CRITERIA 
E.1 Females who are pregnant or breastfeeding 
E.2 Undergone an amputation of the left upper extremity 
E.3 Diagnosed with dextrocardia 
E.4 Subjects who have a pacemaker 
4.4 
SUBJECT WITHDRAW / EARLY TERMINATION  
Subjects who withdraw from the study before using the CM Device will be replaced. The reason 
the subject withdrew from the study may be recorded; subjects are not required to provide a 
reason. Subject withdrawal / early termination criteria may include but are not limited to: 
W.1 Subject requests to be withdrawn from the study or withdraws consent. 
W.2 Subject refuses to comply with required study procedures. 
W.3 An Adverse Event (“AE”) makes the continuation of the subject impossible or 
inadvisable 
W.4 The Investigator determines it is in the subject’s best interest to discontinue from 
the study. 
 
5 
STUDY PROCEDURES 
Figure 1: Study Procedure Overview 
 
5.1 
ENROLLMENT 
A subject will be considered enrolled in the study after provided written informed consent. 
5.1.1 INFORMED CONSENT 
The Investigator or qualified designated study personnel will complete the Informed Consent 
process before any study procedures may occur. The subject will be provided an IRB-approved 
version of the Informed Consent Form (ICF). The subject will have an ample amount of time to 
ENROLLMENT 
• Consent
•Inclusion/exclusion criteria
• Standard Research Screening 
Record
• Additional demographics and 
medical history
STUDY PROCEDURE
• Prepare the device and subject [new subject ID]
• Start monitoring session [8+ minutes]
• Press 'MARK EVENT' then start apheresis procedure
• Press 'MARK EVENT' when apheresis procedure is 
complete
• Record blood pressure
• Continue monitoring post-procedure [10+ minutes]
• Document adverse events and deviations
• Disconnect the subject - participation is complete

 
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read the ICF and ask questions before providing written consent. The subject will receive a signed 
copy of the ICF. The Investigator or qualified designated study personnel will record that consent 
was obtained prior to performing study procedures. 
5.2 
BASELINE DATA 
Baseline data collection will include obtaining health screening data directly from the standard 
research screening record at the study site. Data not available on the apheresis procedure record 
will be captured on a paper case report form (CRF). These data will include skin tone, smoking 
history, and if they are currently taking any cardiovascular medications or supplements that could 
impact their physiological response to the donation procedure. Subjects will self-report they are 
not currently pregnant or have been pregnant in the previous 6-weeks, and that will be captured 
on the research screening record. 
5.3 
STUDY PROCEDURE 
The study procedure will consist of connecting the CM Device to the study subject and starting a 
monitoring session at least 8 minutes prior to starting the scheduled apheresis procedure, wearing 
the monitor during the blood component donation, and continuing to wear the monitor for 10 
minutes after the apheresis procedure is complete.   
5.3.1 PREPARING DEVICE FOR OPERATION 
The Investigator or qualified designated study personnel will prepare the device for use by 
following the directions within the CM Instructions for Use (IFU) manual.  
Once the device has been set up and turned on, the Investigator or designated personnel will 
insert a USB external storage device (refer to “Data Storage Mode” in the IFU).  The USB 
indicator icon should appear on the Monitoring Screen, signaling that the USB storage drive is 
connected and recognized.  
Designated study personnel must ensure that the subject ID number is advanced for 
each subject enrollment prior to starting a new monitoring session.   
After the device is prepared for operation, the Investigator or qualified designated study personnel 
will prepare the subject for device operation by referencing the Instructions for Use (IFU) manual. 
The subject will be placed in a supine position after the device is prepared for operation and 
maintain this position through observation. 
5.3.2 CM DEVICE MONITORING SESSION 
The Investigator or designated study personnel will operate the device by referencing the 
Instructions for Use (IFU) manual and following the study-specific steps outlined below. 
• 
Start the monitoring session by pressing “START” on the CM Device display 
monitor/monitoring screen. A message will appear informing the user that the monitoring 
session is in progress and the patient’s baseline is being established. The device will begin 
to measure all five (5) parameters. 

 
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• 
As monitoring continues, the display will show ECG and PPG pulse waveforms along with 
the Relative Index graph over time. Baseline measurements, for all parameters, are taken 
at the beginning of the monitoring session and is critical to the performance of the Relative 
Index. The subject should be relaxed during baseline establishment. The subject should 
remain in a supine position. The baseline measurement will continue for a minimum of 8 
minutes.   
• 
Immediately prior to the start of the apheresis procedure, the Investigator or 
designated study personnel will press the “MARK EVENT” button on the CM Device 
which will signify the start of the procedure on the device.  A message will appear 
informing the user that an event has been marked. 
• 
Continue the monitoring session during the venipuncture and donation procedure. Upon 
completion of the donation procedure, the Investigator or designated study 
personnel should press “MARK EVENT” and continue the monitoring for a 
minimum of ten (10) minutes.  
• 
A message will appear informing the user that an event has been marked.  The subject 
should remain still and lay in a supine position for the entirety of the observation period. 
After the observation period has passed, “STOP” shall be pressed to end the monitoring 
session. The user will need to press “Yes” on the confirmation window to stop the 
monitoring session after pressing “STOP”.  
• 
If blood pressure was not captured as standard of care for the donation procedure, it 
should be taken immediately prior to or after pressing “MARK EVENT” while the subject 
is still connected to the device.   
• 
Document any observations or adverse events that occur throughout the entirety of the 
monitoring session. 
• 
After the monitoring session is stopped, remove the electrode array sets from the subject 
and dispose of the electrodes per site guidelines. 
5.4 
ADVERSE EVENTS 
Adverse Events (AE), Serious Adverse Events (SAE), or Unanticipated Adverse Device Effect 
(UADE) that occur after informed consent and before completion of the study will be recorded. 
SAE’s may require follow-up contact via a telephone call, depending on the nature of the SAE. 
5.5 
SUBJECT COMPLETION 
Subjects’ participation in the study will be considered complete once the monitoring session has 
ended and device removed.   
6 
DEVICE MANAGEMENT  
6.1 
UNPACKING AND INSPECTION 
It is the responsibility of the Principal Investigator (PI) to ensure that all study devices are 
unpacked and inspected prior to using in any study procedures. Upon arrival, the Investigator or 
designated study personnel will remove the device display monitor and accessories from the 
shipping container; ensure all device components are received. The study site must inform the 

 
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Sponsor of any missing or damaged items within seven (7) days.  Devices with any missing or 
damaged items cannot be used and shall be replaced. 
6.2 
ACCOUNTABILITY, STORAGE & DISPENSATION 
It is the responsibility of the Principal Investigator to ensure all study devices are inventoried and 
accounted for. The Investigator or qualified designated study personnel will record all information 
on the Device Accountability forms maintained in the Investigator Site Files (ISF). 
The investigational device will be stored at the study center. When not in use, the device will be 
stored in a secure location (i.e., area with limited access or in a locked cabinet) under appropriate 
environmental conditions found in the Instructions for Use (IFU) manual. 
The study device shall only be used under the supervision of the Principal Investigator or 
designated study personnel on authorized study subjects. 
6.3 
CLEANING & RETURN 
The study device shall be cleaned before each use. Cleaning procedures will be followed per the 
Instructions for Use (IFU) manual. The device should always be turned off and disconnected 
before cleaning.  The study device and any unused accessories shall be returned to the Sponsor 
after study completion.  
7 
RISKS & BENEFITS 
7.1 
RISK DETERMINTATION & REDUCTION 
This study is determined to be exempt, non-significant risk. An Investigational Device Exemption 
will not be submitted based on this determination. 
Study subjects are subject to risk no greater than or similar to risks associated with undergoing 
a blood donation. The study device and use of the device do not meet the definition of 
significant risk under 21CRF 812.3 (m). All adverse events will be recorded and analyzed to 
evaluate their significance. Possible risks may include:  
- 
[Possible, Rare] Skin irritation or discomfort could occur from the electrodes 
- 
[Possible, Mild] Discomfort could occur due to lying in a supine position for duration of 
the donation procedure.  
 
Every possible effort will be made to reduce the risks to a minimum. Investigators or qualified 
designated study personnel will be experienced and skilled in apheresis procedures, receive 
training on the protocol and use of the device. All adverse events will be documented and reported 
to the Sponsor. 
7.2 
BENEFITS 
This study is for research purposes only. There is no direct benefit to subjects participating in the 
study. Information from this study may help other people in the future. 

 
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8 
SAFETY ASSESSMENT AND MANAGEMENT  
Safety will be assessed by reviewing and summarizing adverse events. 
8.1 
SAFETY DEFINITIONS 
8.1.1 ADVERSE EVENT (AE)  
An Adverse Event (AE) is defined as any untoward medical occurrence, whether or not related to 
the study device or study procedure. AE’s are characterized by grading, actions taken, 
relationship to donation or study procedure, and outcome. These definitions are in the 
corresponding tables below. All adverse events related to the blood donation procedure will be 
recorded and reported in addition to those that may occur specific to the protocol-defined study 
procedure.  All attempts should be made to ensure resolution of the adverse event upon study 
completion.  
Table 1: Adverse Event Severity Grading 
Severity 
Description 
Grade 1: Mild 
Awareness of signs or symptoms, but they are easily tolerated 
Grade 2: Moderate 
Enough discomfort to cause interference with usual activity 
Grade 3: Severe 
Incapacitating, with the inability to work or do usual activity 
Grade 4: Fatal 
Subject expired/death occurred 
 
Table 2: Adverse Events Action(s) Taken 
 
Action Taken 
(Check all that apply) 
Description 
None 
No actions were taken, observation only. 
Medications  
Subject required medication(s) 
Other Treatment  
Subject required other treatment(s) 
Early Withdrawal 
Adverse event led to early study withdrawal 
 
Table 3: Adverse Event Relationship to Donation or Study Procedure 
 
Relationship 
Description 
None 
Causal relationship can be ruled out 
Possible – Donation 
Procedure 
Causal relationship is reasonably possible to the blood donation 
procedure (i.e., the relationship cannot be ruled out) 
Possible – Study 
Procedure/Device 
Causal relationship is reasonably possible to the protocol-required 
study procedure and/or device (i.e., the relationship cannot be ruled 
out)  
Yes – Donation 
Procedure 
Causal relationship to the donation procedure is certain  
Yes – Study 
Procedure/Device 
Causal relationship to the study procedure and/or device is certain  
 

 
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Table 4: Adverse Event Outcome 
 
Outcome 
Description 
Recovered/Resolved 
Subject recovered and event was resolved upon study completion 
Recovered/Resolved with 
Sequelae 
Subject recovered but exhibited lingering minor symptoms upon 
study completion 
Recovering 
Adverse event persisted upon study completion but was 
improving  
Not Recovered 
Adverse event persisted upon study completion and was not 
exhibiting any signs of improvement 
Death  
Subject expired  
Unknown 
Status of the adverse event was unknown upon study 
completion 
 
8.1.2 SERIOUS ADVERSE EVENT (SAE)  
An SAE is defined as an AE that meets any of the following criteria: Fatal or life-threatening*; 
requires or prolongs in-subject hospitalization**; results in persistent or significant 
disability/incapacity; congenital anomaly/birth defect; important medical event. An event’s severity 
grading, action(s) taken, relationship to the donation or study procedure, and the outcome will all 
be used for SAE’s. 
*Life-threatening is defined as an event in which the subject was at risk of death at the time of the 
event. It does not refer to an event that hypothetically may have caused death if it was more 
severe. 
**In-subject hospitalization is defined as an event in which the subject was admitted to the hospital 
for one or more days, even if released on the same day or an emergency room visit, which results 
in admission to the hospital. Emergency room visits that do not result in admission to the hospital 
should be evaluated for one of the other serious outcomes criteria. 
8.1.3 UNANTICIPATED ADVERSE DEVICE EFFECT (UADE)  
An unanticipated adverse device effect is defined by 21 CFR 812.3 as any serious adverse effect 
on the health of safety or 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 supplementary plan or application, 
or any other unanticipated serious problem associated with the device that relates to the rights, 
safety, or welfare of subjects. The Investigator or designee will indicate if they believe an event 
was an unanticipated adverse device effect on the case report form, and the Sponsor will evaluate 
for reporting requirements defined below.  
8.2 
SAFETY REPORTING  
Safety reporting begins at the time of signed Informed Consent and ends at subject study 
completion.  

 
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Investigators shall submit to the Sponsor a report of any AE’s or SAE’s that occur during the study 
within five (5) working days but no later than ten (10) days after the Investigator learns of the 
event.  
Investigators shall submit to the Sponsor and to the reviewing IRB a report of any UADE(s) that 
occur during the study as soon as possible but no later than five (5) working days after the 
Investigator learns of the effect. Sponsors will evaluate UADE’s. 
8.2.1 REPORTING EVENTS & SAFETY CONTACTS 
Events will be reported, in writing, to the Sponsor as soon as possible but no later than five (5) 
working days after the Investigator learns of the event. In an event resulting in the death of the 
subject, the event will be reported within 24-hours of knowledge of the event. The Sponsor is 
responsible for fulfilling IRB and regulatory reporting requirements.  
Table 5: Study Reporting Contacts 
Contact 
Contact Information 
Principal Investigator 
Samantha Mack, MD 
smack@vitalant.org 
303-363-2222 
Sponsor 
Representative 
Zynex Monitoring Solutions  
E: Clinical@zynex.com  
P: (800) 495-6670   
IRB 
WCG IRB 
1019 39th Ave., SE, Suite 120 
Puyallup, WA 9837 
855-818-2289 
Mailing Address 
Zynex Monitoring Solutions  
Attn: ZMS Clinical  
9555 Maroon Circle  
Englewood, CO 80112 
 
9 
STATISTICAL METHODS AND CONSIDERATIONS 
9.1 
SAMPLE SIZE DETERMINATION 
This is a two-phase hypothesis generating study; therefore, hypothesis testing will not be 
performed. The sample size of 25 subjects for the first phase and 200 total subjects is empirically 
determined to be sufficient for an early-phase pilot study characterizing the performance of the 
Relative Index during an apheresis donation procedure. The results in the first phase will be used 
to help the sponsor determine if the enrollment is continued in the second phase. This decision 
based on the results in the first phase will be purely empirical, not based on planned statistical 
hypothesis testing.   

 
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9.2 
ANALYSIS SET  
All eligible subjects who were enrolled in the study and used the study device will be included in 
the analyses. Subjects who withdraw after enrollment and before device use will be excluded from 
the analyses.  
9.3 
DESCRIPTIVE STATISTICS 
Descriptive statistics will be calculated for all endpoints and measures. Continuous variables will 
be summarized in terms of the mean, standard deviation (SD), median, quartiles, minimum, 
maximum and number of observations. Categorical variables will be summarized in terms of the 
number of subjects providing data, frequency count and percentage.  
 
9.4 
DEMOGRAPHIC AND BASELINE CHARACTERISTICS 
All demographic and baseline variables collected at enrollment will be summarized using 
descriptive statistics.   
9.5 
STATISTICAL ANALYSIS  
The data for this study will be summarized using descriptive statistics. There is no formal 
hypothesis testing planned for this study. Point estimates and the corresponding confidence 
intervals will be presented for the statistical analysis. If data are normally distributed, the 
confidence interval of the mean will be constructed based on a t-distribution. Otherwise if data are 
skewed, distribution-free confidence interval of the median will be calculated. For proportions, a 
two-sided 95% confidence interval will be calculated using the Clopper-Pearson method.  
 
The primary evaluations pertaining to the performance of the CM Device will examine the 
behavior the Relative Index value in accordance with subject outcomes and conditions that 
present during the apheresis donation procedures. Baseline performance of the CM Device will 
be set in the Relative Index before the procedure.  The primary analysis will utilize the descriptive 
statistics to characterize the changes in the CM Device Relative Index during an apheresis 
procedure comparing to the baseline values. The analysis, however, can include investigation 
into individual vital sign parameters that the CM Device (or another source) produces during a 
subject’s donation or 10-minute post-donation observation period.  
 
Analysis of data sets collected from all subjects aim to satisfy the following purposes, included 
but not limited to:  
• 
Examine, on a case-by-case review basis, the results produced by the CM Device for 
relevant subject case results. This could include analyzing data and comparing to 
expected/observed information as a result of this trial, from either the CM Device, from the 
principal investigator, designated study personnel, or Sponsor observers.  
• 
Classify aggregate results by subject outcomes, particularly nominal and hemorrhagic 
shock/complications (if observed), and evaluate the performance of the CM Device to 
indicate either the presence of the presenting complication or specify the absence of 
presenting complications.  
• 
Investigate statistical relevance of aggregate subject outcomes (where applicable for 
similar resulting outcomes and/or presenting complications), with analytic components 
possibly including but not limited to:  

 
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o Determination of the sensitivity for the CM Device to identify fluid changes in study 
subjects  
o Determination of the specificity of the CM Device to identify normal recovery 
conditions of a subject after the apheresis donation procedure where no cases of 
hemorrhage, related shock, or other complications present.  
o Compilation of relevant trends and patterns, including applicable metrics such as 
mean, max/min, standard deviation, expected linear trajectories, etc. of the 
Relative Index data results for aggregate data, as classified by patient outcomes 
and total fluid lost and re-infused. 
 
Descriptive analysis will be conducted when 25 subjects are enrolled and complete the first phase. 
The analysis results will be used to determine the enrollment for the second phase in an empirical 
manner. The final analysis will be conducted when the study is complete.  
 
10 DATA COLLECTION, RETENTION, AND MONITORING  
10.1 DATA COLLECTION 
The Investigator will prepare, maintain, and retain complete, current, accurate, organized, and 
legible Source Documents to record all observations and other pertinent data for each subject. In 
some instances, case report forms (CRFs) will serve as source documentation. The Investigator 
or designated study personnel will provide the Sponsor redacted standard procedure records with 
the subject ID number for the majority of the data collection requirements. Any required data not 
collected as standard of care for the apheresis procedure will be captured on study-specific paper 
case report forms.   
Corrections of data on paper CRFs or source documents will be made by crossing out the 
incorrect data and making the correction. Each correction will be initialed and dated by the study 
personnel making the correction.  
The Investigator is responsible for the information collected on subjects enrolled in the study. All 
data collected during the study must be reviewed and verified for completeness and accuracy by 
the Investigator. If any corrections are made after the Investigators signature, the Investigator will 
also initial and date the correction. 
10.1.1 SUBJECT CONFIDENTIALITY 
In order to maintain subject confidentiality, records identifying the subject will be kept in a safe 
and secure location; access to these records will be on a limited basis. Only the subject 
identification number, gender, and age will identify study subjects on CRFs and other 
documentation submitted to the Sponsor.  A limited number of Sponsor representatives may have 
access to identifiable information and will take reasonable precautions to maintain the 
confidentiality of the subject’s identity. 
10.2 DATA RETENTION 
All study records will be stored in a safe and secure location. Records will be retained per 
applicable regulatory requirements, which include for a period of 2 years after the latter of the 

 
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following two days: the date which the investigation is terminated or completed, or the date that 
records are no longer required for purposes of supporting premarket approval applications or a 
notice of completion of a product development protocol. The Investigator site may transfer custody 
or records to the Sponsor with appropriate documentation recording the transfer. 
10.3 MONITORING 
10.3.1 MONITORING PLAN 
Monitoring visits will be conducted by representatives of the Sponsor or study site or both 
according to 21 CFR 812. (c) for non-significant risk device studies and ICH Guidelines. By signing 
this protocol, the Investigator grants permission to the Sponsor (or designee) and all appropriate 
regulatory authorities to conduct on-site or electronic monitoring or auditing or both of all 
appropriate study documentation. 
11 STUDY ADMINISTRATION  
11.1 AUDITS AND INSPECTIONS 
External auditors and government inspectors may evaluate the study and must be allowed access 
to CRFs, source documents, and other study files. Audit reports will be confidential.  
11.2 PROTOCOL AND ICF AMENDMENTS 
Sponsor approval is required for any protocol or ICF amendment. Protocol or ICF amendments 
will not be implemented without prior written IRB approval except as allowed per the IRB 
procedures/approval and as necessary to eliminate immediate safety hazards to subjects. A 
protocol amendment intended to eliminate an apparent immediate hazard to subjects may be 
implemented immediately, provided IRBs are notified within five (5) working days. The Informed 
Consent form will be reviewed and updated as necessary at the time of the protocol amendment.  
11.3 PROTOCOL DEVIATIONS 
A protocol deviation is defined as any accidental or unintentional changes to, or non-compliance 
with the IRB approved research protocol. Any deviation from the protocol must be documented 
and reported to the Sponsor within 10 working days and reported to the IRB as applicable to 
regulatory requirements. Protocol deviations that pose an immediate risk or significant hazard to 
subjects must be reported to the Sponsor within 24 hours and reported to the IRB no later than 5 
working days after the emergency occurred. In the instance, an Investigator uses a device without 
obtaining informed consent; the Investigator shall report to the Sponsor and the IRB within 5 
working days as per 21 CFR 812.150 (1) (5).  
12 ETHICAL AND OTHER REGULATORY CONSIDERATIONS 
It is the responsibility of the Investigator that the study is conducted according to the Declaration 
of Helsinki, Protection of Human Volunteers (21 CFR 50), Institutional Review Board (21 CFR 
56), and Responsibilities of Clinical Investigators (21 CFR 812 (e)). 
12.1 INSTITUTIONAL REVIEW BOARD (IRB) REVIEW 
The Protocol, ICF, and any subject facing material will be reviewed and approved by the IRB prior 
to study initiation. The Sponsor will maintain responsibility for obtaining IRB approval and 

 
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submitting all required study reports to the IRB.  Amendments to the Protocol, ICF, or any subject 
facing material will not be implemented without prior written IRB approval unless to eliminate an 
apparent immediate hazard to subjects. All IRB approvals will be kept in the Trial Master File and 
Investigator Site File. 
12.2 WRITTEN INFORMED CONSENT 
The Informed Consent Form (ICF) and Informed Consent process will include all elements 
required by applicable regulations. Informed consent will be obtained in accordance with the 
Declaration of Helsinki, ICH, Good Clinical Practice, and US Code of Federal Regulations for 
Protection of Human Subjects (21 CFR 50.25 [a,b], 21 CFR 50.27, and 21 CFR Part 56, Subpart 
A), the Health Insurance Portability and Accountability Act (HIPAA) when applicable, and local 
regulations.  
A properly executed, written informed consent will be obtained from all subjects prior to entering 
the subject into the trial, unless waived by the IRB. ICF information will be given in both verbal 
and written form. The subject must be given an ample amount of time to read the ICF. The subject 
must provide written consent by signing and dating the approved ICF. A signed copy of the ICF 
will be provided to the subject; originals will be maintained with the subject’s study records.  
Assents Forms will not be permitted as subjects must be over the age of 18 to meet the 
Inclusion/Exclusion criteria. Legally Authorized Representatives will not be permitted as subjects 
must have the ability to provide written consent to meet the Inclusion/Exclusion criteria. 

 
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12.3 REFERENCES 
 
1 Little R, Kirkman E, Driscoll P, Hanson J, Mackay-Jones K.   Preventable Deaths after 
Injury:  Why are the Traditional “Vital” Signs Poor Indicators of Blood Loss.  Journal of Accident 
and Emergency Medicine. 1995;12: 1-14. 
2 Convertino VA, Moulton SL, Grudic GZ, Rickards CA, Hinojosa-Laborde C, Gerhardt RT, et al. 
Use of advanced machine-learning techniques for noninvasive monitoring of hemorrhage. The 
Journal of trauma. 2011;71(1 Suppl):S25-32.  
3 Ansari D, Tingstedt B, Lindell G, Keussen I, Ansari D, Andersson R. Hemorrhage after Major 
Pancreatic Resection: Incidence, Risk Factors, Management, and Outcome. Scand J Surg. 
2017;106(1):47-53. doi:10.1177/1457496916631854  
4 Kubik M, Mandal R, Albergotti W, Duvvuri U, Ferris RL, Kim S. Effect of transcervical arterial 
ligation on the severity of postoperative hemorrhage after transoral robotic surgery. Head Neck. 
2017;39(8):1510-1515. doi:10.1002/hed.24677  
5 Hsieh CE, Chou CT, Lin CC, et al. Hemodynamic Changes Are Predictive of Coagulopathic 
Hemorrhage After Living Donor Liver Transplant. Exp Clin Transplant. 2017;15(6):664-668. 
doi:10.6002/ect.2016.020  
6 Frank SM, Savage WJ, Rothschild JA, Rivers RJ, Ness PM, Paul SL, et al. Variability in blood 
and blood component utilization as assessed by an anesthesia information management system. 
Anesthesiology. 2012;117(1):99-106. 
 
 

 
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13 
ABBREVIATIONS AND DEFINITIONS OF TERMS 
 
Table 6: Abbreviations and Definition of Terms 
 
Abbreviation 
Definition 
AE 
Adverse event 
BPM 
Beats per minute 
BP 
Blood pressure 
C 
Celsius 
CFR 
U.S. Code of Federal Regulations 
CM-1500 
Cardiac Monitor, Model 1500 
CM-1600 
Cardiac Monitor, Model 1600 
CRF 
Case report form 
ECG  
Electrocardiogram 
e.g. 
Exempli Gratia (for example) 
FDA  
U.S. Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
HR 
Heart rate 
ICF 
Informed Consent Form 
ICH 
International Council for Harmonization 
IFU 
Instructions for Use 
IRB 
Institutional Review Board 
ISF 
Investigator Site File 
ISO 
International Organization for Standardization 
lb. 
Pound; unit of mass 
ohms 
Plural unit of electrical resistance 
mL 
Milliliter 
PHI 
Protected Health Information 
PI 
Principal Investigator 
PPG 
Photoplethysmogram  
SAE 
Serious adverse event 
UADE 
Unanticipated Adverse Device Event 
ZMS 
Zynex Monitoring Solutions