A Prospective Observational Study of Air Burden in Intravenous Tubing: Factors That Increase Patient Risk
Phase: NA
Conditions: Air Embolism, Air Leakage, Air Burden
Sponsor: ClearLine MD

 
AirPurgeTM AIR DETECTION AND 
REMOVAL SYSTEM 
Post-Approval Multi-center  
Clinical Protocol 
CS001-02LL Rev. B 
Page 1 of 21 
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Study Sponsor / Study Funded by:   
 
Anesthesia Safety Products (ASP), LLC  
300 TradeCenter, Suite 5400 
Woburn, MA  01801 
781.933.6500 
 
 
Commercially Available 
Device: 
 
AirPurgeTM AIR DETECTION AND REMOVAL SYSTEM FOR USE WITH 
INTRAVENOUS (I.V.) LINES 
 
Medical Monitor: 
 
Achi Ludomirsky, M.D. 
 
CONFIDENTIAL 
The information in this post-approval clinical protocol is confidential in nature and is for the 
use of the Institutional Review Board (if applicable)/Principal Investigator/Clinical Study 
Personnel and others directly involved in the study title.  No unpublished information 
presented in the contents of this document may be referred to in publication or public 
presentation without the prior express written consent of Anesthesia Safety Products (ASP). 
 
 
  
 
PRINCIPAL INVESTIGATOR 
 
Print Name of Principal Investigator 
 
 
 
Signature 
 
Date 
 


 
AirPurgeTM AIR DETECTION AND 
REMOVAL SYSTEM 
Post-approval Multi-center  
Clinical Protocol 
CS001-02LL Rev. B 
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Table of Contents: 
 
Section # 
Section Title 
Page # 
A 
List of Abbreviations 
4 
B 
Post-Approval Multi-center Study Summary 
4 
1.0 
Introduction 
5 
1.1 
Background 
5 
1.2 
Commercially Available Device 
5 
1.3 
Intended Use & Indications for Use 
5 
1.4 
Preclinical Data 
6 
1.5 
Risks and Benefits 
6 
1.5.1 
Risks of Device 
6 
1.5.2 
Other Risks of Study Participation 
6 
1.5.3 
Potential Benefit Analysis 
6 
2.0 
Study Objectives 
7 
2.1 
Primary Study Objectives 
7 
3.0 
Study Design 
7 
3.1 
General Design 
7 
3.2 
Study Duration 
8 
3.3 
Study Population 
8 
4.0 
Subject Selection and Withdrawal 
8 
4.1 
Inclusion Criteria 
8 
4.2 
Exclusion Criteria 
8 
4.3 
Study Subject Recruitment and Screening 
9 
4.4 
Early Withdrawal of Study Subjects 
9 
4.4.1 
When and How to Withdraw Subjects 
9 
4.4.2 
Data Collection for Withdrawn Subjects 
9 
4.4.3 
Study Subject Discontinuation 
9 
5.0 
Study Device 
9 
5.1 
Description 
9 
5.2 
Standardized Study I.V. Parameters / Set-Ups 
10 
5.3 
Packaging 
10 
5.4 
Contraindications 
10 
5.5 
Warnings 
10 
5.5 
Power 
10 
5.7 
Mounting the Device 
11 
5.8 
Installing the Cartridge 
11 
5.9 
System Start-up / Clearing the Lines 
11 
5.10 
Replacing Full Collection Bag 
12 
5.11 
Replacing Empty I.V. Bag 
12 
5.12 
Infusion Warmers 
12 
5.13 
Infusion Pumps 
12 
5.14 
Indicators and Alarms 
12 
5.15 
AirPurge System Disposable Cartridge Storage 
13 

 
AirPurgeTM AIR DETECTION AND 
REMOVAL SYSTEM 
Post-approval Multi-center  
Clinical Protocol 
CS001-02LL Rev. B 
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5.16 
Cleaning and Maintenance 
13 
5.17 
Device Returns 
13 
6.0 
Study Procedure 
13 
6.1 
Schedule of Events 
13 
6.2 
Eligibility Checklist / Demographics 
14 
6.3 
Operative Report 
14 
6.4 
Data Monitor 
15 
7.0 
Statistical Plan 
15 
8.0 
Safety Issues 
16 
8.1 
AirPurge System Indicator Lights / Alarms 
16 
8.2 
Protocol Deviations, Device Complaints and Reportable Events 
16 
8.3 
Definitions 
16 
8.4 
Medical Monitoring 
17 
9.0 
Data Handling and Record Keeping 
17 
9.1 
Confidentiality 
17 
9.2 
Case Report Forms (CRFs) and Source Documents 
17 
9.3 
Records / Materials to be Maintained 
18 
10.0 
Administrative Information 
18 
10.1 
Investigator Selection and Qualifications 
18 
10.2 
Informed Consent Process (Optional) 
18 
10.3 
Institutional Review Board (IRB) (Optional) 
19 
10.4 
Protocol Amendments 
19 
10.5 
Subject Identification (ID) Number 
19 
11.0 
Training and Monitoring 
19 
11.1 
Data Monitoring 
19 
11.2 
Clinical Site Monitoring / Training 
19 
11.3 
Safety Monitoring 
20 
12.0 
Publication 
20 
13.0 
References 
20 
--- 
Attachment 1 – Schedule of Events 
21 
 
 
 
 

 
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REMOVAL SYSTEM 
Post-approval Multi-center  
Clinical Protocol 
CS001-02LL Rev. B 
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A. List of Abbreviations: 
AirPurge 
 
 
AirPurge Air Detection and Removal System 
CRF 
 
 
 
Case Report Form 
I.V.  
 
 
 
Intravenous 
Kg 
 
 
 
Kilogram 
ml 
 
 
 
Milliliters 
RH 
 
 
 
Relative Humidity 
MDR 
 
 
 
Medical Device Reporting 
SIV 
 
 
 
Site Initiation Visit 
 
B. Post-approval Multi-center Study Summary  
Title 
AirPurgeTM Air Detection and Removal System Post-approval Multi-
center Clinical Protocol 
Protocol Number 
CS001-2 
Methodology 
Prospective, observational, single arm / non-randomized post-
approval study design 
Study Duration 
6-8 weeks 
Clinical Sites 
Multi-center; up to 5-8 Clinical Sites 
Objectives 
To measure the amount of air removed from the intravenous (I.V.) line by 
the AirPurge System in a clinical setting and to measure the frequency and 
duration of the AirPurge purging mechanism activity in a clinical setting 
with standardization of the procedure, I.V. fluid and I.V. line. 
Number of Subjects 
 
50 Study Subjects per Clinical Site; 200 to 300 Study Subjects in 
Total 
Primary Inclusion 
Criteria / Procedure 
Intravenous Fluid  or Blood Delivery in Pediatric and Adult Patient 
Populations Undergoing arterial septal defect closure, ballooning of 
coarctation, craniotomy, craniosynostosis, patent ductus arteriosis, 
(pda) closure, pulmonary artery stent deployment, pulmonary valve 
balloon dilatation, spinal fusion, scoliosis or cardiac surgery 
involving cardiopulmonary bypass 
Commercially 
Available Device and 
Planned Use 
AirPurgeTM Air Detection and Removal System used to remove air 
from intravenous line 
Statistical 
Methodology 
Final data analysis will be presented in text, tables, and graphical 
representations including mean, standard deviation and range 
outcomes and a time analysis of AirPurge purging activity during 
the procedure 
 

 
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REMOVAL SYSTEM 
Post-approval Multi-center  
Clinical Protocol 
CS001-02LL Rev. B 
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1.0 INTRODUCTION 
This document is a protocol for a human research post-approval study.  This study is to be 
conducted in accordance with applicable Good Clinical Practice standards and individual Clinical Site 
research policies and procedures. 
1.1 BACKGROUND 
The AirPurge System is identified by the FDA as “an Intravascular Administration Set, Automated Air 
Removal System”.  It was classified as a Class II device under the De Novo process (K080644) and 
cleared for release for commercial marketing on March 4th, 2014.   
The AirPurge System is designed to: 
 
Detect & remove air bubbles automatically with practically unhindered I.V. flow 
 
Remove air bubbles during infusion rates as high as 400 ml/minute 
 
Remove air bubbles as small as 25 micro-liters at high or low flow rates 
 
Remove air automatically during surgical procedures from intravenous solutions, blood, and 
blood products in I.V. setups that have single or multiple bags 
 
Eliminate the need for time-consuming manipulation during in-line air bubble removal (and 
the adjunct possibility of needle sticks). 
1.2 COMMERCIALLY AVAILABLE DEVICE 
The commercially available Class II AirPurge Air Detection and Removal System is comprised of the 
AirPurge Device (control unit) and disposable Cartridge.  In this protocol they are referred to as the 
AirPurge System, the Device or the Cartridge.  The Device functions by:  
 
a) Detecting air in the intravenous (I.V.) line using software-controlled ultrasound sensing 
technology 
b) Diverting the flow in the I.V. line to the Collection Bag using a two pinch valve configuration, 
when air is detected, and 
 c) Redirecting fluid back to the patient line after passage of the entrapped air. 
 
The Device detects air in the I.V. line via two sensors (line-in and line to Collection Bag) and diverts 
flow into the Collection Bag.  Flow to the patient is resumed when sensors indicate no air.  
Therefore, some of the I.V. fluid will be channeled to the Collection Bag during air removal.  The 
volume of this I.V. fluid channeled to the Collection Bag is dependent on the I.V. flow rate and 
bubble configuration, (i.e., a discrete bubble or a string of connected bubbles). 
 
Flow Rate 
I.V. Fluid Volume Loss Per Purge 
400 ml per minute 
~7 ml 
300 ml per hour 
~0.1 ml 
 
1.3 INTENDED USE & INDICATIONS FOR USE 
The usage of the AirPurge System with Disposable Cartridge in conjunction with this post-approval 
clinical study will be in accordance with the Intended Use and Indications for Use from the AirPurge 
Operator’s Manual reviewed by FDA under De Novo K080644 (approval date:  3.4.2014). 

 
AirPurgeTM AIR DETECTION AND 
REMOVAL SYSTEM 
Post-approval Multi-center  
Clinical Protocol 
CS001-02LL Rev. B 
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Intended Use:  The AirPurge System is intended for the detection and automatic removal of air in 
intravenous lines during administration of blood, blood products and intravenous solutions. 
 
Indications for Use:  The AirPurge System is intended for the detection and automatic removal of air 
in intravenous lines during administration of blood, blood products, and intravenous solutions.  It is 
indicated for use in the operating room and post anesthesia care areas.  The AirPurge System is 
placed below I.V. bags using gravity feed or pressure, and may be used with or without fluid 
warmers.   
 
1.4 PRECLINICAL DATA   
De Novo K080644 which was approved by FDA on March 4, 2014 included the following preclinical 
supportive material:  design FEMA, design functionality, sterilization and shelf life, biocompatibility, 
software verification and validation, electromagnetic compatibility / electrical safety, patient 
transport, cartridge internal clamp and overall device performance bench verification, validation and 
usability testing.  The AirPurge System has been tested and found to be in compliance with IEC 
60601-1-2 1994 medical device limits. 
1.5 RISKS AND BENEFITS 
1.5.1 RISK OF DEVICE 
Use of the AirPurge System in this post-approval study represents no more than minimal to no 
additional risk beyond the routine use of intravenous (I.V.) fluid delivery since all Clinical Sites will be 
instructed to follow their standard of care visualization techniques for air bubble detection and 
removal below the AirPurge System and therefore there will be no modification in Clinical Sites’ 
routine air bubble detection and removal procedures at the most distal end of the I.V. line closest to 
the patient; air filter usage if a standard of care will be placed below the AirPurge System.  Clinical 
Sites will be trained on the proper use of the AirPurge including the importance of clearing the line 
before connection to the patient.  Any boluses or critical medicine / contrast media delivery will be 
conducted below the AirPurge device.  Risk mitigation will begin prior to study onset at each Clinical 
Site with a thorough review / Clinical Site personnel training on the recommended operating 
instructions provided in the AirPurge System Quick Operating Instructions and Operator’s Manual 
including the Warnings and Caution sections from a risk related standpoint. 
1.5.2 OTHER RISKS OF STUDY PARTICIPATION 
No other risks of study participation have been identified since Clinical Sites will not be requested to 
modify their routine air bubble detection and removal procedures at the most distal end of the I.V. 
line closest to the patient.  
1.5.3 POTENTIAL BENEFIT ANALYSIS 
The AirPurge System provides automatic removal of air in intravenous (I.V.) lines during 
administration of intravenous solutions in the operating room and post anesthesia care areas.  The 
major potential benefits include: 
 
Improved safety; reduced risk of venous air embolisms and associated complications (heart 
failure, stroke, extended recovery times, impaired cognition)  
 
Simple, hands free, auto purge, intuitive operation 

 
AirPurgeTM AIR DETECTION AND 
REMOVAL SYSTEM 
Post-approval Multi-center  
Clinical Protocol 
CS001-02LL Rev. B 
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 
Labor and attention saving convenience resulting from auto-purge function 
 
Reduced risk of clinician needle sticks while de-airing I.V. bags and lines 
 
Compatible with other infusion technologies, standard fluids, and flow rates. 
2.0 STUDY OBJECTIVES 
2.1 PRIMARY STUDY OBJECTIVES 
The primary objectives of this post-approval clinical study are: 
 
1) to measure the amount of air removed from the intravenous (I.V.) line by the AirPurge System in a 
clinical setting with standardization of the surgical procedure, I.V. fluid and flow rate 
 
2) to measure the  frequency and duration of the AirPurge purging mechanism activity in a clinical 
setting with standardization of the procedure, I.V. fluid and I.V. line. 
3.0 STUDY DESIGN 
 
3.1 GENERAL DESIGN 
The AirPurge Air Detection and Removal System Post-Approval Multi-Center Clinical Study is a 
prospective, observational, single arm / non-randomized post-approval study design. This multi-
center post-approval clinical study is not a comparative study design nor is the clinical design 
intended to support the functional safety and efficacy of the commercially available AirPurge 
System for the purposes of obtaining FDA approval.  Therefore, there is no investigational device 
and no prospective safety / efficacy success criteria or endpoints.  The AirPurge System will be 
utilized for the current FDA approved intended use / indications for use.  The overall goal of this 
post-approval study is information gathering in regards to the clinical value of the AirPurge System 
within the operating room setting utilizing a set of controlled I.V. set-up parameters including I.V. 
fluid, I.V. line including the usage of key I.V. pole accessory equipment and a standardized group of 
procedures. 
 
The study endpoint is the discontinuation of AirPurge System usage during the procedure and 
therefore there are no post-procedure follow-up requirements minimizing the risk of lost-to follow-
up study subjects.  Study subjects will be recruited from the Clinical Sites’ current patient population 
scheduled to undergo one of the inclusion criteria procedures.  Subjects will be enrolled into the 
study in a sequential manner. 
 
Data collection is limited to two time points: 
 
The hard copy CS001-12LL Eligibility Checklist / Demographics case report form (CRF) will be 
completed prior to surgery.  Operative Day data will be collected utilizing two data collection 
methodologies as follows: 
 
1) CS001-13LL Operative Report:  This hard copy case report form (CRF) will be completed by 
Clinical Site personnel and collect information on device performance from the clinician’s 
perspective, intravenous line fluid delivery specifics, and relevant background concerning 
the procedure. 

 
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REMOVAL SYSTEM 
Post-approval Multi-center  
Clinical Protocol 
CS001-02LL Rev. B 
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2) Data Monitor:  The Data Monitor consists of hardware and software that are independent of 
and do not affect operation of the AirPurge device.  The Data Monitor resides in the battery 
pack area of the AirPurge from which the batteries have been removed.  The Data Monitor 
will collect objective data to measure 1) the amount of air removed from the intravenous 
line by the AirPurge, 2) the frequency and duration of AirPurge mechanism activity and 3) 
the occurrence of any alarm conditions in the AirPurge. 
3.2 STUDY DURATION 
Study duration is limited to the collection of preoperative eligibility criteria / baseline demographic 
information and procedure data.  There are no post-procedure follow-up requirements for this post-
approval study.    
3.3 STUDY POPULATION 
The study population for this post-approval clinical study will be comprised of up to 50 study 
subjects per Clinical Site with up to 5-8 participating Clinical Sites in total; 200-300 study subjects.  
Study Subjects will be drawn from Clinical Sites’ pediatric and adult patient populations who are 
scheduled to undergo one of the following procedures:  arterial septal defect closure, ballooning of 
coarctation, craniotomy, craniosynostosis, patent ductus arteriosis, (pda) closure, pulmonary artery 
stent deployment, pulmonary valve balloon dilatation, spinal fusion, scoliosis or cardiac surgery 
involving cardiopulmonary bypass.    
 
4.0 SUBJECT SELECTION AND WITHDRAWAL 
4.1 INCLUSION CRITERIA 
Potential study subjects meeting all of the following criteria will be considered suitable study 
subjects.   
 
Male or female, any race 
Pediatric or adult patient  
1.0 
Study Subject’s weight is at least 5kg. 
2.0 
Study Subject scheduled to undergo one of the following procedures:  arterial septal defect 
closure, ballooning of coarctation, craniotomy, craniosynostosis, patent ductus arteriosis, 
(pda) closure, pulmonary artery stent deployment, pulmonary valve balloon dilatation, 
spinal fusion, scoliosis or cardiac surgery involving cardiopulmonary bypass 
3.0 
Study Subject or acceptable parent / guardian is able to provide written informed consent, if 
Clinical Site requires 
4.2 EXCLUSION CRITERIA 
Any study subject who does not meet all of the above inclusion criteria will be excluded from this 
clinical study.  In addition, any study subject who meets one or more of the following exclusion 
criteria will also be excluded from study enrollment: 

 
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REMOVAL SYSTEM 
Post-approval Multi-center  
Clinical Protocol 
CS001-02LL Rev. B 
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1.0 
Study Subject’s scheduled procedure involves the use of an infusion pump on the I.V. line 
that AirPurge will be attached to 
2.0 
Study Subject plans to participate or has participated in any other clinical trial within the 30 
days prior to the start of the study. 
3.0 
Study Subject cannot be a homeless person, have an active drug/alcohol dependence or 
abuse history.  
4.3 STUDY SUBJECT RECRUITMENT AND SCREENING 
Study Subjects will be drawn from Clinical Sites’ pediatric and adult patient populations who are 
scheduled to undergo one of the study procedures.  Any study-specific recruitment materials will be 
reviewed by overseeing IRBs, if applicable.  The commercially available FDA approved labeling 
materials may be utilized to explain the AirPurge device, based on Investigator preference. 
 
4.4 EARLY WITHDRAWAL OF STUDY SUBJECTS 
4.4.1 WHEN AND HOW TO WITHDRAW SUBJECTS  
An Investigator may choose to discontinue a study subject from the study during the course of the 
procedure if in the opinion of the Investigator this action is in the best welfare of the study subject.  
If a study subject is withdrawn from the clinical study, this information will be recorded on the 
Operative Report including the reason for withdrawal.  Subjects may also be withdrawn after the 
Eligibility Checklist / Demographics case report form has been completed based on Investigator 
judgment.   
 
4.4.2 DATA COLLECTION FOR WITHDRAWN SUBJECTS  
 
The Study Sponsor should be notified of any withdrawn study subjects and any completed CRFs 
submitted to the Study Sponsor with the reason for withdrawal. 
4.4.3 STUDY SUBJECT DISCONTINUATION 
Study subjects will be clearly informed during the Informed Consent process (if applicable) that they 
are free to withdraw from this post-approval study after they sign the Informed Consent Document 
and before their procedure.  If this should occur, the Clinical Site should document the Study 
Subject’s wish to discontinue their study participation by recording the date and reason for 
discontinuation (if available) on the study subject’s Eligibility Checklist / Demographics form. 
5.0 STUDY DEVICE 
5.1 DESCRIPTION  
The commercially available Class II AirPurge Air Detection and Removal System is comprised of the 
AirPurge Device (control unit) and disposable Cartridge.  In this protocol they are referred to as the 
AirPurge System, the Device or the Cartridge.   
 
The Study Sponsor will provide training on the recommended operation of the AirPurge System per 
ASP user training procedure; SOP-007, prior to the first study surgical procedure at each Clinical Site.  
Clinical Site personnel should read the “AirPurgeTM System Quick Operating Instructions” and 

 
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REMOVAL SYSTEM 
Post-approval Multi-center  
Clinical Protocol 
CS001-02LL Rev. B 
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“AirPurgeTM System – Air Detection and Removal System with Intravenous (I.V.) lines Operator’s 
Manual” thoroughly before use and have both readily available during device operation. 
5.2 STANDARDIZED STUDY I.V. PARAMETERS / SET-UPS 
The AirPurge System will be mounted to the “Active” I.V. line being used for maintenance and fluid 
replacement.  The Intravenous Fluid and Flow Rate parameters will be standardized as follows for all 
study subjects: 
 
I.V. Line: 
The AirPurge will be mounted to the free-flow, maintenance line  
I.V. Fluid: 
Lactated Ringer’s or Blood 
Fluid warmers may or may not be used based on each Clinical Site’s standard of care practices.  The 
usage of a warmer and type of warmer will be recorded on the Operative Report.   
Air filters may be used below the AirPurge based on each Clinical Site’s standard of care practices.  
Clinical Sites should follow their routine procedures for air bubble detection and elimination below 
the AirPurge. 
During this post-approval study, the following Equipment Set-Ups should not be used with the 
intravenous line connected to the AirPurge System:  infusion pumps, inflatable pressure cuffs, 
pressurized infusers, rapid infusion systems or catheters.  Any boluses or syringe injections should 
be delivered below the AirPurge. 
If at any point during the procedure, it is in the best interest of the patient’s welfare to modify this 
standard free-flow rate, the Investigator should proceed and record on the Operative Report, 
documenting the reason for modification.  Deviation from the standardized flow will be categorized 
as a protocol deviation for analysis purposes. 
5.3 PACKAGING 
The reusable AirPurge Device(s) will be provided to each Clinical Site prior to the Site Initiation Visit 
and Clinical Site personnel training.  An inventory of single-use only AirPurge Cartridges will be 
shipped sterile to Clinical Sites by Study Sponsor.  Since the AirPurge is not investigational, no 
investigational device accountability process will be required.  If any devices are damaged during 
shipment the Clinical Site will be instructed to notify the Study Sponsor. 
5.4 CONTRAINDICATIONS 
Do not use with fluids that are incompatible with standard I.V. lines. 
5.5 WARNINGS  
For a comprehensive description of all AirPurge System Warnings and Cautions refer to the 
“AirPurgeTM System – Air Detection and Removal System with Intravenous (I.V.) lines Operator’s 
Manual”.  Key study relevant Warnings are provided below: 
 
a. The AirPurge System cannot purge air from I.V. extension line between AirPurge System and 
patient.  The I.V. extension line must be cleared of air before connected to patient.  Failure to clear 

 
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REMOVAL SYSTEM 
Post-approval Multi-center  
Clinical Protocol 
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extension line could result in introduction of air to patient that could result in death or serious 
injury. 
b. Fluid warmers, if used, must be installed above the AirPurge. 
c. Mount the AirPurge lower than the infusion source, not higher than 4 feet (125 cm) and at or 
slightly below patient level.  The I.V. pole should be vertical at all times 
d. The AirPurge will not reliably purge air at flow rates greater than 400 ml/minute 
e. Flow is diverted into the Collection Bag during air purging. Critical medication and contrast media 
should be injected below the AirPurge. 
5.6 POWER 
After plugging the AirPurge System into AC source, confirm all 3 battery lights are illuminated.  Note:  
AC power (and not battery power) will be used for all study procedures.  
5.7 MOUNTING THE DEVICE 
Mount the AirPurge Device on the I.V. pole in a vertical position.  Plug into AC outlet.  
 
WARNING: The IV Pole must be kept vertical at all times. If the IV pole becomes non-vertical while 
the AirPurge System is in use, then: 
  
-Check for air in the line connected directly to the study subject and take immediate and 
appropriate actions consistent with basic/standard I.V. practices. 
 
 -Check to see if any of the I.V. setup, tubing, equipment, has been damaged or 
disconnected; if yes, discontinue and restart the I.V. therapy set-up, as appropriate and 
consistent with basic/standard I.V. practices. 
 
If the IV setup, tubing, and equipment, has not been damaged or disconnected, return the IV pole to 
a vertical position and check the functioning of the AirPurge System. If it is ON and not alarming 
then AirPurge System is removing all the air flowing into the AirPurge System. 
5.8 INSTALLING THE CARTRIDGE 
NOTE:  Have “AirPurgeTM System Quick Operating Instructions” available for a quick reference  
in the O.R.  Handle according to your institution’s procedures for sterile devices. 
a. Remove single-use Cartridge from sterile pouch.  Collection Bag connector must be tight; Blue and 
Green caps mounted in place. 
b. Remove Red retaining clip; and discard.  Open the Device Door.  With FRONT of Cartridge facing 
you, push Cartridge onto pegs in the device.  Close and latch the door. 
5.9 SYSTEM START-UP / CLEARING THE LINES 
CAUTION:  Only use I.V. lines with Luer Lock connectors.  When connecting the I.V. line to the top 
and bottom of Cartridge, do not over tighten Luer connections.  Tighten connections only until slight 
resistance is felt. 
 
a. Remove Green inlet cap on top of Cartridge and connect primary I.V. to connector of Cartridge 
marked IN.  Remove Blue outlet cap on bottom of Cartridge and connect the extension set to the 
connector at bottom of the Cartridge marked OUT.  Ensure there are no kinks in any tubing. 

 
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REMOVAL SYSTEM 
Post-approval Multi-center  
Clinical Protocol 
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b. Turn the Device on.  All front panel indicators (9) will illuminate for 3 seconds, then only the ON 
button and 3 battery lights (indicating AC power is present) will remain lit.  If any other Indicator 
lights stay on or if there is an audible alarm, refer to Operator’s Manual and follow instructions.  
Record information regarding all indicators / alarms on the Operative Report. 
c. Start fluid flow for the primary I.V. lines.  The Cartridge will fill with fluid; any air in line will be 
detected and diverted into the Collection Bag.  When free of air, flow will then be diverted back to 
extension line.  Once air free I.V. fluid clears the extension line, connect to the patient. 
 
WARNING:  The AirPurge System cannot purge air from I.V. extension line between AirPurge System 
and patient.  The I.V. extension line must be cleared of air before connected to patient.  Failure to 
clear extension line could result in introduction of air to patient that could result in death or serious 
injury. 
5.10 REPLACING FULL COLLECTION BAG 
a. Do not turn off the AirPurge.  Open a new Cartridge package and remove Collection Bag by 
disconnecting Luer connector. 
b. Ensure AirPurge is not purging (PURGING Indicator not lit) and pause flow into the AirPurge (e.g. 
clamp line). 
c. Disconnect Luer connector to remove Full Collection Bag and attach New Collection Bag. 
d. Resume flow. 
5.11 REPLACING EMPTY I.V. BAG 
a. Do not turn off the AirPurge.  Replace I.V. bag as usual. (The AirPurge will remove air admitted 
into primary I.V. line and divert liquid flow back to study subject line). 
b. If drip rate is too slow, increase the drip rate until “PURGING Light is off and flow is resumed to 
the study subject. 
5.12 FLUID WARMERS 
a. Any Fluid Warmer can be used based on the Clinical Site’s preference and routine standard of care 
practices.   
b. Follow Fluid Warmer manufacturer Instructions for Use (IFU). 
c. Install Fluid Warmer ABOVE the AirPurge System.  The AirPurge System can be connected to the 
Fluid Warmer with standard extension I.V. line sets. 
5.13 INFUSION PUMPS 
Infusion Pumps should not be used on the AirPurge line.  
5.14 INDICATORS AND ALARMS 
Refer to page 13 of the AirPurge Operator’s Manual for further information on Indicators and 
Alarms.  The incidence and timing of any Indicator Light or Alarm will be documented on the 
Operative Report. 
 
 
Indicator 
Alarm 
Solution 
TEMP 
Yes 
Discontinue Use.  Turn Device Off and Open Door.  
Monitor Air Bubbles Manually & Contact ASP for Service. 

 
AirPurgeTM AIR DETECTION AND 
REMOVAL SYSTEM 
Post-approval Multi-center  
Clinical Protocol 
CS001-02LL Rev. B 
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TURN OFF- 
OPEN DOOR 
Yes 
Discontinue Use.  Turn Device Off and Open Door.  
Monitor Air Bubbles Manually & Contact ASP for Service. 
DOOR 
Yes 
Ensure Cartridge is Inserted Correctly, Red Retaining Clip 
Removed & Door Securely Latched. If Alarm Persists 
Discontinue Use and Contact ASP for Service. 
↑↑VERT 
Yes 
Reposition Device on I.V. Pole using Clamp.  When 
Positioned Correctly Device Resets Itself. 
PURGING 
PURGING Indicator Lights 
when device Purging.   
After 1 minute (Indicator 
begins Blinking + Alarm) 
DO NOT TURN OFF Device. 
Check I.V. Line for Obstructions or I.V. bag Empty* 
 
Very Low Flow Rates can Cause Purge Times > 1 Minute; 
Wait for Alarm to Silence. 
  
 *If Alarm persists discontinue use.  Turn device off and open door.  Monitor air bubbles manually 
and contact ASP for service. 
5.15 AIRPURGE
 SYSTEM DISPOSABLE CARTRIDGE STORAGE 
Temperature 
-20 to 60°C 
Relative Humidity 
10 to 93 %RH 
Air Pressure 
500 to 1060hPa (15-31Hg) 
Elevation 
0 to 9800 feet 
5.16 CLEANING AND MAINTENANCE 
a. Cartridges and Collection Bags are for single use only.  Dispose in your medical waste. 
b. Refer to Operator’s Manual for AirPurge Device cleaning and disinfecting instructions. 
 
5.17 DEVICE RETURNS 
Any AirPurge Devices or Cartridges that do not function properly should be returned to the Study Sponsor for 
device complaint evaluation after Study Sponsor notification.  Contact Customer Service for return 
instructions. 
6.0 STUDY PROCEDURE 
6.1 SCHEDULE OF EVENTS 
Data collection for this post-approval study will occur as described in the below table.  Data 
collection and required study visits are limited to the preoperative completion of the CS001-12LL 
Eligibility Checklist / Demographics and the Operative Day which involves both data collection from 
Clinical Site Personnel on the CS001-13LL Operative Report and objective measurements collected 
via the Data Monitor which is attached to the USB port on the AirPurge System.  Refer to Schedule 
of Events provided in Attachment 1 for additional details. 
 
 
 
 
 
 
 
 
   

 
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REMOVAL SYSTEM 
Post-approval Multi-center  
Clinical Protocol 
CS001-02LL Rev. B 
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Data Collection 
 
Visit Timeframe 
CS001-12 Eligibility Checklist / 
Demographics  
Prior to Procedure* (Visit 1) 
CS001-13 Operative Report 
Operative Day (Visit 2) 
Data Monitor 
Operative  Day (Visit 2) 
(Collected by Sponsor upon completion of 
Clinical Site’s enrollment/ procedures**)  
*If study-specific Informed Consent Document (ICD) used, ICD must be signed prior to completion of 
CS001-12 Eligibility Checklist / Demographics 
** Collection may occur at periodic intervals during study to verify Data Monitor operation  
6.2 ELIGIBILITY CHECKLIST / DEMOGRAPHICS  
Visit 1 will involve Clinical Site personnel collection of the following data fields: 
 
Subject ID 
Date / Time  
Age 
Gender 
Race 
Height 
Weight 
Surface Area 
Scheduled Procedure Reason / Diagnosis for Procedure 
Medication History 
6.3 OPERATIVE REPORT 
Visit 2 will involve Clinical Site personnel collection of the following data fields: 
 
Subject ID # 
Procedure Date 
Procedure Start and End Time 
AirPurge Start Time and End Time  
Procedure (circle one):  arterial septal defect closure, ballooning of coarctation, craniotomy, 
craniosynostosis, patent ductus arteriosis, (pda) closure, pulmonary artery stent deployment, 
pulmonary valve balloon dilatation, spinal fusion, scoliosis or cardiac surgery involving 
cardiopulmonary bypass 
Procedure Complications  
Use of Fluid Warmer   
I.V. Fluid and Bag Volume 
Additional I.V. Line Activity 
Confirm AirPurge used on Free-flow maintenance line 
AirPurge Waste Collection Bag 
AirPurge Alarms  
AirPurge Complaints 

 
AirPurgeTM AIR DETECTION AND 
REMOVAL SYSTEM 
Post-approval Multi-center  
Clinical Protocol 
CS001-02LL Rev. B 
Page 15 of 21 
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6.4 DATA MONITOR 
Visit 2 will also involve the collection of the following objective measurements through the Data 
Monitor software: 
-Total time (in milliseconds) that the AirPurge sensor detects incoming air in order to calculate total actual air 
volume captured 
-How often purge mechanisms kicks in 
-Frequency & Duration of Purging 
-Total Time AirPurge device powered on, number of times device power turned on and off and number of 
Device Alarms Detected 
 
7.0 STATISTICAL PLAN 
This multi-center post-approval clinical study is not a comparative study design nor is the clinical 
design intended to support the functional safety and efficacy of the AirPurge System for the 
purposes of obtaining FDA approval.  Therefore, there are no prospective safety / efficacy success 
criteria or endpoints.  The overall goal of this post-approval study is information gathering in regards 
to the clinical value of the AirPurge System utilizing a set of controlled I.V. set-up parameters and 
group of procedures. 
 
All available data will be entered into standard Excel spreadsheets for analysis purposes and data 
entry verified prior to the final analysis.  Planned data analyses include: 
 
1) CS001-12LL Eligibility Checklist / Demographics:  Data will be analyzed using standard 
demographic variable presentation for age, race, gender, height, weight and surface 
area and to record any pre-existing conditions (medical / drug) that could impact 
intravenous fluid delivery during the procedure. 
2) CS001-13LL Operative Report:   Data collected will be used to evaluate the clinical 
activity in the clinical setting to provide key background regarding the overall procedure, 
I.V. fluid delivery parameters and the operation of the AirPurge.  Data will be presented 
for individual study subjects, as applicable and for the overall study population as a 
whole. 
3) Data Monitor:  The Study Sponsor will analyze the objective measurement data 
collected from the Data Monitor software and correlate Data Monitor measurements 
with the clinical data collected from Clinical Site personnel and documented on the 
CS001-13LL Operative Report.  Analytical measurements will include:   
-Total volume of air captured (mean, range and SD) for individual study 
subjects and the overall study population as a whole) 
-Duration of AirPurge purge mechanism activity (mean, range and SD) for 
individual study subjects and the overall study population as a whole) 
-Frequency of AirPurge purge mechanism activity (mean, range and SD) for 
individual study subjects and the overall study population as a whole) to 
answer questions concerning the necessity of purging over the duration of a 
procedure (e.g. number of purging episodes; length of time between 
purging episodes) 

 
AirPurgeTM AIR DETECTION AND 
REMOVAL SYSTEM 
Post-approval Multi-center  
Clinical Protocol 
CS001-02LL Rev. B 
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-Summary of the incidence of AirPurge alarms and indicators will be 
prepared 
-An analysis between the objective measurements collected with the Data 
Monitor and the clinical activity reported on the Operative Report to 
correlate what was occurring clinically during purging activity. 
The final data analysis will be presented in text, tables, and graphical representations including a 
graphical time analysis of AirPurge usage over the duration of the procedure. 
 
8.0 SAFETY ISSUES 
8.1 AIRPURGE
 SYSTEM INDICATOR LIGHTS / ALARMS  
Device performance in the clinical setting will be monitored as part of this post-approval study.  The 
incidence and timing of AirPurge System Indicator Lights and Alarms during the procedure will be 
described on the CS001-13LL Operative Report with objective data collected via the Data Monitor.  
The incidence of procedure complications will also be recorded on the CS001-13LL Operative Report. 
8.2 PROTOCOL DEVIATIONS, DEVICE COMPLAINTS AND REPORTABLE EVENTS  
NOTE:  The following safety data will be collected for Study Sponsor notification as described below.  
Clinical Site personnel will be responsible for notifying the Study Sponsor within 24 hours of any 
device complaints, potential medical device reporting (MDR) reportable events or significant 
protocol deviations.  In addition, Clinical Sites conducting this post-approval study under 
Institutional Review Board (IRB) oversight will follow the guidelines outlined by their overseeing IRB 
for the reporting of the incidence of device complaints, medical device reporting (MDR) reportable 
events (including IRB notification and the completion of Form 3500A Medwatch Forms), as 
appropriate or significant protocol deviations.   
 
Clinical Investigators / participating Clinical Sites should make every effort to comply with all aspects 
of this post-approval clinical protocol and not deviate in any way from the standardized protocol 
requirements. The Clinical Site will document any protocol deviations that may occur on the 
Operative Report and for Clinical Sites conducting the post-approval study under IRB oversight, the 
Principal Investigator will be responsible for submitting any significant protocol deviations to the IRB 
for review, based on individual IRB requirements.  The Study Sponsor should be notified of any 
significant protocol deviations within 24 hours of occurrence.  
8.3 DEFINITIONS 
Complaint:  Any written, electronic or oral communication that alleges deficiencies related to the 
identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is 
released for distribution. 
 
Medical Device Reporting (MDR) Reportable Event (or Reportable Event): 
(1) An event that user facilities become aware of that reasonably suggests that a device has 
or may have caused or contributed to a death or serious injury; or 
(2) An event that manufacturers or importers become aware of that reasonably suggests 
that one of their marketed devices: 

 
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REMOVAL SYSTEM 
Post-approval Multi-center  
Clinical Protocol 
CS001-02LL Rev. B 
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(i) May have caused or contributed to a death or serious injury, or 
(ii) Has malfunctioned and that the device or a similar device marketed by the 
manufacturer or importer would be likely to cause or contribute to a death or 
serious injury if the malfunction were to recur. 
 
Serious Injury: An injury or illness that: 
(1) Is life-threatening, 
(2) Results in permanent impairment of a body function or permanent damage to a body 
structure, or 
(3) Necessitates medical or surgical intervention to preclude permanent impairment of a 
body function or permanent damage to a body structure. 
8.4 MEDICAL MONITORING 
It will be the responsibility of the Principal Investigator at each Clinical Site to closely monitor not 
only the overall study conduct at their Clinical Site but to oversee the safety outcomes from all study 
procedures.  The Medical Monitor will be responsible for reviewing data from all Clinical Sites and 
providing guidance to the Investigator group, as necessary. 
 
9.0 DATA HANDLING AND RECORD KEEPING 
9.1 CONFIDENTIALITY 
Information about study subjects will be kept confidential and managed according to the 
requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  Clinical 
Sites should follow the requirements of their institution, overseeing IRB and any and all applicable 
state and federal privacy regulations. 
9.2 CASE REPORT FORMS (CRFS) AND SOURCE DOCUMENTS 
The following standardized hard-copy case report forms (CRFs) will be utilized during this post-
approval clinical study: 
 
 
*CS001-12LL Eligibility Checklist / Demographics 
 
 
*CS001-13LL Operative Report 
 
 
 
The CS001-12LL Eligibility Checklist / Demographics will be completed by the Clinical Site prior to the 
surgical procedure.  If the Clinical Site is utilizing a study-specific Informed Consent Document for 
this post-approval clinical study, the CS001-12LL Eligibility Checklist / Demographics should not be 
completed until after the Informed Consent Document has been signed.  The CS001-13LL Operative 
Report will be completed by the Clinical Site during / shortly after the procedure. 
 
Copies of the hard-copy forms will be maintained by the Clinical Sites and the originals of these 
forms will be sent to Anesthesia Safety Products.  Clinical Site source documents (e.g. operative 
notes) may be used to assist in the completion of the study-specific hard copy case report forms. 
 
All data requested on the CRF must be recorded.  All missing data must be explained.  If a space on 
the CRF is left blank because the procedure was not done or the question was not asked, write 
“N/D”.  If the item is not applicable to the individual case, write “N/A”.  All entries should be printed 

 
AirPurgeTM AIR DETECTION AND 
REMOVAL SYSTEM 
Post-approval Multi-center  
Clinical Protocol 
CS001-02LL Rev. B 
Page 18 of 21 
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legibly in black ink.  If any entry error has been made, to correct such an error, draw a single straight 
line through the incorrect entry and enter the correct data above it.  All such changes must be 
initialed and dated.  DO NOT ERASE OR WHITE OUT ERRORS.  For clarification of illegible or 
uncertain entries, print the clarification above the item, then initial and date it. 
   
9.3 RECORDS/MATERIALS TO BE MAINTAINED 
The Principal Investigator will maintain copies of the completed CS001-12LL Eligibility Checklist / 
Demographics and CS001-13LL Operative Report CRFs, all completed / signed Informed Consent 
Documents (if applicable), all IRB correspondence (if applicable) and the Clinical Study Binder.  The 
Clinical Site will send the original completed CS001-12LL Eligibility Checklist / Demographics and 
CS001-13LL Operative Report CRFs to Anesthesia Safety Products on a periodic basis throughout the 
duration of the post-approval study.  The Clinical Site will return the Data Monitor to Anesthesia 
Safety Products upon completion of the last procedure.  These records will be considered 
confidential and proprietary to Anesthesia Safety Products.  Clinical Sites under the oversight of an 
IRB will follow their IRB’s requirements for the length of record retention (typically a minimum of 2 
years).  
 
10.0 ADMINISTRATIVE INFORMATION 
10.1 INVESTIGATOR SELECTION AND QUALIFICATIONS      
Investigators will be selected based on their experience with intravenous line fluid delivery in the 
clinical setting, their qualifications for participation in a post-approval clinical study and their 
willingness to adhere to the Investigator responsibilities and requirements outlined in this post-
approval clinical study protocol. 
 
10.2 INFORMED CONSENT PROCESS (OPTIONAL) 
The ASP AirPurge System is commercially available in the United States under De Novo K080644 and 
therefore informed consent is not required by a Clinical Site in order to participate in this post-
approval clinical study.  For Clinical Sites interested in obtaining informed consent, (either in 
conjunction with an Institutional Review Board (IRB) or not), Anesthesia Safety Products has 
prepared an Informed Consent Document template.  If an Informed Consent is utilized, the 
document should be signed prior to the completion of the CS001-12LL Eligibility Checklist / 
Demographics case report form (CRF) and the study subject’s procedure.  In addition, Clinical Sites 
utilizing an IRB should follow all of their IRB’s guidelines for obtaining informed consent and study 
conduct.  

 
AirPurgeTM AIR DETECTION AND 
REMOVAL SYSTEM 
Post-approval Multi-center  
Clinical Protocol 
CS001-02LL Rev. B 
Page 19 of 21 
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10.3 INSTITUTIONAL REVIEW BOARD (IRB) (OPTIONAL) 
The ASP AirPurge System is commercially available in the United States under De Novo K080644 and 
therefore Institutional Review Board (IRB) is not required by a Clinical Site in order to participate in 
this post-approval clinical study.  Clinical Sites who choose to conduct this post-approval clinical 
study under IRB oversight will be responsible for completing all necessary paperwork and following 
the guidelines set forth by their IRB including use of the IRB approved Informed Consent document 
and any specific Clinical Site reporting requirements. 
10.4 PROTOCOL AMENDMENTS 
In the event that a revision to this post-approval clinical protocol is made after study onset, 
information concerning protocol amendments will be provided to the Principal Investigator at each 
Clinical Site.  A protocol history listing any protocol amendments, if they should occur, will be 
provided by the Study Sponsor for the Clinical Site’s records.  For Clinical Sites conducting the post-
approval study under IRB oversight, the Principal Investigator will be responsible for submitting any 
protocol amendments to the IRB for review, based on individual IRB requirements. 
10.5 SUBJECT IDENTIFICATION (ID) NUMBER  
Each study subject in the clinical study will be identified by a unique subject ID number which will be 
recorded on the Eligibility Checklist / Demographics Report and Operative Report forms.  The Study 
Sponsor will provide each Clinical Site with a subject ID number list.    
 
11.0 TRAINING & MONITORING 
The Study Sponsor will have three types of monitoring performed to ensure compliance with this 
clinical protocol and to provide each participating Clinical Site with adequate training concerning the 
operation of the AirPurge System and all clinical study responsibilities: 
 
 
data monitoring 
 
administrative monitoring /Clinical Site training 
 
safety monitoring 
11.1 DATA MONITORING 
The Study Sponsor will review all hard-copy study case report forms (CRFs) to verify completeness of 
documentation including missing and/or incomplete forms to ensure that the documentation is 
being completed properly and that all study case report forms are collected for analysis.  Clinical 
Sites will be contacted in regards to missing forms and to clarify any unreadable data from the hard-
copy forms, when necessary. 
 
The Study Sponsor will oversee the objective measurement data collected from the Data Monitor to 
verify that the Data Monitor(s) performed as intended at each participating Clinical Site.  
 
11.2 
ADMINISTRATIVE MONITORING / CLINICAL SITE TRAINING 
A site initiation visit (SIV) will be conducted at each Clinical Site prior to the enrollment of their first 
study subject to assure that Clinical Investigator(s) and Clinical Site personnel are adequately trained 
on the recommended operation of the AirPurge System and Data Monitor to be used in conjunction 

 
AirPurgeTM AIR DETECTION AND 
REMOVAL SYSTEM 
Post-approval Multi-center  
Clinical Protocol 
CS001-02LL Rev. B 
Page 20 of 21 
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with this clinical study.  The clinical protocol will be reviewed in-depth with all relevant Clinical Site 
personnel during pre-enrollment conference calls to ensure all questions have been addressed and 
that overall study responsibilities have been clearly outlined and understood. 
 
The Study Sponsor will remain in constant communications with each participating Clinical Site 
throughout the duration of the clinical study to monitor overall clinical study enrollment, case report 
form completion, informed consent and IRB reporting requirements (as applicable) and to provide 
any technique device troubleshooting support, as necessary. 
11.3 SAFETY MONITORING 
The Study Sponsor will review study outcomes to assure the continued safety of the device and that 
no study subjects are exposed to unwarranted risk. 
 
12.0 PUBLICATION 
Neither the complete nor any part of the results of the study carried out under this protocol, nor 
any of the information provided by the Study Sponsor for the purposes of performing the study, will 
be published or passed on to any third party without the consent of the Study Sponsor.  Any 
Investigator involved with this study is obligated to provide the Study Sponsor with complete test 
results and all data derived from the study. 
 
13.0 REFERENCES 
1. Chau D, Tzanetos D, Zhang C et al. A dangerous side of in-line IV filters when used for 
vasoactive infusions in infants. Offic Jour Anesthesia Patient Safety Foun 2013;(Fall):1-7. 
2. Giraldo M, Lopera LM, Arango M. Venous air embolism in neurosurgery. Columbian Jour 
Anesthesiology 2015;43(S1):40-44. 
3. Gordy S, Rowell S. Vascular air embolism. Intl Jour Critical Illness & Injury Science 
2013;3(1):73-76. 
4. Minski M, Lele A, Fitzsmimmons L et al. Diagnosis and treatment of vascular air embolism. 
Anesthesiology 2007;106(1):177. 
5. Muth C.M., Shank E.S. Gas embolism. New England Jour Med 2000;342(7):476-482. 
6. Sowell M, Lovelady C, Brogdon B.G. et al. Infant death due to air embolism from peripheral 
venous infusion. J Forensic Sci 2007;52(1):183-188. 
7. Wilkins RG, Unverdorben M. Accidental intravenous infusion of air. Jour Infusion Nursing 
2012;35(6):404-408.   
 
 
 
 
 
 
  
 
 

 
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REMOVAL SYSTEM 
Post-approval Multi-center  
Clinical Protocol 
CS001-02LL Rev. B 
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Attachment: 1 
Schedule of Events 
 
Activity 
Visit 1 
Eligibility 
Checklist/ 
Demographics 
Visit 2 
Operative Report 
Visit 2 
Data  
Monitor 
Study Team Procedures 
  
  
 
Informed Consent 
X 
 
Age 
X 
 
Gender 
X 
 
Race / Ethnicity 
X 
 
 
Height 
X 
 
Weight 
X 
 
Surface Area 
X 
 
Scheduled Procedure 
X 
 
 
Reason / Diagnosis for Procedure 
X 
 
 
Medication History 
X 
 
 
Operative Assessments 
 
Performed Procedure 
X 
 
I.V. Line Set-up (including all accessories) 
 
X 
 
I.V. Line Activity (fluid, confirm free-flow 
maintenance line, # bags) 
 
X 
 
AirPurge Usage (including purging activity, 
alarms/indicators, #collection bags, remaining 
collection bag status) 
 
X 
 
Procedure Complications 
 
X 
 
 Device Complaints 
X 
 
Data Monitor Software Collected Data 
 
Duration / Frequency of Purge Mechanism 
Activity 
 
 
X 
Volume of Air Removed 
 
 
X 
 Incidence / Timing of Alarms & Indicators 
X