Clinical Evaluation of the CM-1500 During Hemodialysis
Phase: NA
Conditions: Fluid Loss, Dialysis
Sponsor: Zynex Monitoring Solutions

 
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CLINICAL PROTOCOL 
ZMS-1500-2021-Dialysis 
NCT#05125848 
11-NOV-2021 
 
 

 
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CLINICAL PROTOCOL 
 
 
TITLE 
 
Clinical Evaluation of the CM-1500 During Hemodialysis  
 
PROTOCOL 
ZMS-1500-2021-Dialysis 
 
SPONSOR 
Zynex Monitoring Solutions (ZMS) 
9555 Maroon Circle 
Englewood, CO 80112 
 
PROTOCOL VERSION 
1.0 
 
 
DOCUMENT REVIEW  
& APPROVAL 
 
 
 
 
 
 
Sponsor Representative: 
 
 
 
 
 
 
Don 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-1500 during Hemodialysis 
PROTOCOL 
ZMS-1500-2021-Dialysis 
SPONSOR 
Zynex Monitoring Solutions (ZMS) 
9655 Maroon Circle 
Englewood, CO 80112 
 
PROTOCOL VERSION 
1.0 
 
 
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 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[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 ....................................................................................................................................... 9 
3.1 
DEVICE DESCRIPTION .................................................................................................................... 9 
3.1.1 
DEVICE DESIGN AND COMPONENTS ................................................................................... 10 
3.2 
PRINCIPLES OF OPERATION ........................................................................................................ 10 
3.3 
INDICATIONS FOR USE ................................................................................................................ 10 
3.4 
INTENDED USE ............................................................................................................................ 10 
4 
SUBJECT POPULATION AND SELECTION ............................................................................................ 10 
4.1 
POPULATION AND ANTICIPATED NUMBER OF SUBJECTS ........................................................... 10 
4.2 
SUBJECT INCLUSION CRITERIA .................................................................................................... 10 
4.3 
SUBJECT EXCLUSION CRITERIA .................................................................................................... 11 
4.4 
SUBJECT WITHDRAW / EARLY TERMINATION............................................................................. 11 
5 
STUDY PROCEDURES .......................................................................................................................... 11 
5.1 
ENROLLMENT .............................................................................................................................. 12 
5.1.1 
INFORMED CONSENT .......................................................................................................... 12 
5.2 
BASELINE DATA ........................................................................................................................... 12 
5.3 
STUDY PROCEDURE ..................................................................................................................... 12 
5.3.1 
PREPARING DEVICE FOR OPERATION ................................................................................. 12 
5.3.2 
PREPARING THE SUBJECT FOR DEVICE OPERATION ........................................................... 13 
5.3.3 
CM-1500 MONITORING SESSION ........................................................................................ 14 
5.4 
REPEAT STUDY PROCEDURES AND STUDY COMPLETION ........................................................... 15 
5.5 
ADVERSE EVENTS ........................................................................................................................ 15 
6 
DEVICE MANAGEMENT ...................................................................................................................... 15 
6.1 
UNPACKING AND INSPECTION .................................................................................................... 15 
6.2 
ACCOUNTABILITY, STORAGE & DISPENSATION .......................................................................... 15 

 
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6.3 
CLEANING & RETURN .................................................................................................................. 15 
7 
RISKS & BENEFITS ............................................................................................................................... 16 
7.1 
RISK DETERMINTATION & REDUCTION ....................................................................................... 16 
7.2 
BENEFITS ..................................................................................................................................... 16 
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) .......................................................................................... 18 
8.1.3 
UNANTICIPATED ADVERSE DEVICE EFFECT (UADE) ............................................................ 18 
8.2 
SAFETY REPORTING ..................................................................................................................... 18 
8.2.1 
REPORTING EVENTS & SAFETY CONTACTS ......................................................................... 18 
9 
STATISTICAL METHODS AND CONSIDERATIONS ............................................................................... 19 
9.1 
SAMPLE SIZE DETERMINATION ................................................................................................... 19 
9.2 
ANALYSIS SET .............................................................................................................................. 19 
9.3 
DESCIPTIVE STATISTICS ............................................................................................................... 19 
9.4 
DEMOGRAPHIC AND BASELINE CHARACTERISTICS ..................................................................... 19 
9.5 
STATISTICAL ANALYSIS ................................................................................................................ 20 
10 
DATA COLLECTION, RETENTION, AND MONITORING ................................................................... 20 
10.1 
DATA COLLECTION ...................................................................................................................... 20 
10.1.1 
SUBJECT CONFIDENTIALITY ................................................................................................. 20 
10.2 
DATA RETENTION ........................................................................................................................ 21 
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 ................................................................ 22 
12.1 
INSTITUTIONAL REVIEW BOARD (IRB) REVIEW ........................................................................... 22 
12.2 
WRITTEN INFORMED CONSENT .................................................................................................. 22 
12.3 
REFERENCES ................................................................................................................................ 23 

 
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13 
ABBREVIATIONS AND DEFINITIONS OF TERMS ............................................................................. 24 
 
FIGURES AND TABLES 
Figure 1: Study Procedure Overview .......................................................................................................... 11 
 
Table 1: Adverse Event Severity Grading .................................................................................................... 17 
Table 2: Adverse Events Action(s) Taken .................................................................................................... 17 
Table 3: Adverse Event Relationship to Hemodialysis or Study Procedure ................................................ 17 
Table 4: Adverse Event Outcome ................................................................................................................ 17 
Table 5: Study Reporting Contacts .............................................................................................................. 19 
Table 6: Abbreviations and Definition of Terms ......................................................................................... 24 
 
 
 

 
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1 
INTRODUCTION 
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 Monitoring Solutions fluid volume monitor, Model 1500 (CM-1500), uses a relative patient 
standard approach by non-invasively and simultaneously monitoring five (5) physiological parameters, 
including bioelectrical impedance, electrocardiogram (ECG) amplitude, photoplethysmogram (PPG) 
amplitude, heart rate, and skin temperature. The CM-1500 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.   
Hemodialysis is a medical procedure performed to remove fluid and waste products from the blood and 
to correct electrolyte imbalances.  Patients with chronic kidney failure often need to undergo 
hemodialysis multiple times each week to prevent fluid overload. The environment in which 
hemodialysis is performed is well-defined, and the amount of fluid volume removed during each session 
is calculated and recorded.  Therefore, examining changes in the RI in hemodialysis procedures will 
provide valuable insights into the performance of the RI in comparison to the individual parameters that 
make up the index, as well as the observed changes that may occur in a patient’s physical status during a 
hemodialysis session.   
 

 
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1.1 
CLINICAL RATIONALE 
The proposed clinical study is designed characterize the changes in the Zynex non-invasive monitoring 
device (CM-1500) Relative Index to track fluid volume changes in subjects consented to undergo a 
hemodialysis procedure.  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, and 
additional studies are going in apheresis blood donation and clinically in the post-anesthesia care unit to 
further characterize the performance of the RI.  Additional research is required to assess Relative Index 
changes when larger fluid volumes are observed and to determine how the individual parameters 
impact the overall device performance in a hemodialysis setting.    
2 
INVESTIGATIONAL PLAN 
2.1 
OBJECTIVES 
The primary objective of the study is to characterize changes in the CM-1500 Relative Index during a 
hemodialysis procedure.   
The secondary objective of the study is to characterize the intersubject and intrasubject variability in 
Relative Index changes across multiple hemodialysis sessions. 
2.2 
STUDY DURATION 
Enrollment in the study is expected to take up to 3 months, and data analysis may take up to an 
additional 2 months to complete.  Each individual subject’s study participation is estimated to last 
approximately 1-2 weeks but may continue for up to 30 days.  If the subject has not completed three (3) 
monitoring sessions within 30 days, participation will be considered complete, and the subject will be 
withdrawn from the study.   
2.3 
STUDY DESIGN 
The study is a prospective, single-arm, non-randomized, non-blinded, non-controlled, non-significant risk, 
single center study enrolling subjects consented to undergo a hemodialysis session as a part of their 
standard prescribed treatment plan.  Subjects will consent to undergo non-invasive monitoring with the 
CM-1500 during three (3) separate hemodialysis sessions.  Attempts will be made to have the monitoring 
sessions sequentially performed with their subsequently planned hemodialysis sessions.  Up to 20 
subjects will be consented and enrolled to ensure 15 subjects complete the study with the required 
number of monitoring sessions.   
3 
STUDY DEVICE  
3.1 
DEVICE DESCRIPTION 
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 CM-1500. 

 
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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. 
3.2 
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.  
3.3 
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. 
3.4 
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. 
4 
SUBJECT POPULATION AND SELECTION 
4.1 
POPULATION AND ANTICIPATED NUMBER OF SUBJECTS 
Up to 20 adult subjects who meet the inclusion and exclusion criteria will be consecutively enrolled in the 
study.  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, 
including connection of the device to the left wrist/hand and maintaining relatively 
motionless during the session  

 
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I.3 
18 years of age or older 
I.4 
Planned to undergo a minimum of three (3) hemodialysis sessions within the two (2) 
weeks following enrollment.  
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 
Subjects with left arm hemodialysis access only 
E.4 
Diagnosed with dextrocardia 
E.5 
Subjects who have a pacemaker 
E.6 
Subjects who have any other underlying condition that would inhibit completion of 
participation in the study, per Investigator opinion 
4.4 
SUBJECT WITHDRAW / EARLY TERMINATION  
Subjects who withdraw from the study before using the CM-1500 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 or is unable 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 
 
ENROLLMENT 
• Consent 
• Inclusion/ 
exclusion 
criteria
• Demographics 
and medical 
history
STUDY PROCEDURE X3
• Prepare the device and subject [Subject ID ##-XX]
• Start monitoring session [wait 5+ minutes]
• Press 'MARK EVENT' then start hemodialysis procedure 
• Press 'MARK EVENT' when hemodialysis is complete
• Continue monitoring post-procedure [10+ minutes] then STOP session
• Document adverse events and protocol devations
• Disconnect the subject and discard electrodes
• Repeat CM-1500 monitoring next 2 subsequent hemodialysis sessions (3 total)
• Subject participation is complete  

 
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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 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 will include collecting age, biological sex, smoking history, limited medication information, 
and high-level medical history.   
5.3 
STUDY PROCEDURE 
The study procedure will consist of connecting the CM-1500 to the study subject on their left arm/wrist 
and starting a monitoring session at least 5 minutes prior to starting the scheduled hemodialysis 
procedure, wearing the monitor during the hemodialysis session, and continuing to wear the monitor for 
10 minutes after the procedure is complete. The Investigator’s standard post-treatment hemodialysis 
record will be collected containing the prescription information, machine set-up, vitals, pre- and post-
treatment data collection and assessment, medications administered, and intradialytics.  
5.3.1 
PREPARING DEVICE FOR OPERATION 
The Investigator or qualified designated study personnel will prepare the device for use by referencing 
the Instructions for Use (IFU) manual following the study-specific steps outlined below. 
S1. 
Complete the Unpacking, Inspection, and Accountability procedures and associated forms 
(refer to IFU for the full procedure). 
S2. 
Ensure the device is in a secure and stable location (refer to IFU for full procedure). 
S3. 
Connect the power supply cord to the display monitor and to an electrical outlet. The light will 
illuminate on the power adapter when it is connected to power.  
S4. 
Connect the CM-1500 wrist cuff trunk cable to the display monitor. The cable should double-
click into the correct insertion position. 
S5. 
Connect the CM-1500 wrist cuff to the trunk cable. The cable should double-click into the 
correct insertion position. 
S6. 
Power on the device by pressing the external “ON/OFF” button located on the right side of the 
display monitor. 
S7. 
Press the “SETUP” button and select the desired user preferences, subject information (subject 
number), data storage mode, and device information. Press “SAVE” after all desired setup 
options are selected—the device will return to the Monitoring Screen. 

 
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a. Select male/female 
b. Ensure the date/time of the CM-1500 aligns with the times that will be recorded in the 
post-treatment hemodialysis record from the hemodialysis machine and clinician 
watches  
c. Enter the subject ID as subject number (01-20) followed by AA, BB, or CC 
corresponding to session 1 (AA), 2 (BB), or 3 (CC). For example, the first subject, first 
session subject ID will be 01-AA and the next session will be 01-BB.   
S8. 
Insert a USB external storage drive (refer to “Data Storage Mode” in the IFU). The USB external 
storage drive should be labeled externally with the device serial number. The USB indicator 
icon should appear on the Monitoring Screen, signaling that the USB storage drive is connected 
and recognized. 
5.3.2 
PREPARING THE SUBJECT FOR DEVICE OPERATION 
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 and 
following the steps outlined below. The subject will be placed in a supine or sitting position after the 
device is prepared for operation and maintain this position through observation. 
S9. 
Clean the subject’s skin on his or her left wrist. 
S10. Take the small white connector/electrode array and remove the transparent plastic film 
attached to the electrodes to expose the adhesive. Place the small white connector/electrode 
array on the dorsal (top) of the subject’s left wrist. The white connector shall be pointed 
medially (inward) towards the subject’s body. 
S11. Take the large blue connector/electrode array and remove the transparent plastic film 
attached to the electrode to expose the adhesive. Place the large blue connector/electrode 
array on the left side of the neck’s base and down across the front of the shoulder (above the 
clavicle). The blue connector shall point away from the neck, extending toward the direction 
of the left shoulder. 
S12. Place the wrist cuff on the subject’s left wrist (above or over the top of the white electrode 
array), with the trunk cable connection pointing up the arm, and secure the wrist strap around 
the left wrist. The cuff should be snug with no gap between the wrist cuff and skin. The wrist 
cuff should not be able to slide or rotate on the wrist nor should it be too tight or restricting of 
blood flow. 
S13. Place the PPG finger glove on the subject’s left digitus II manus (Index) fingertip. The white 
cable/top side of the finger glove should be on the dorsal (top) side of the finger. The fingertip 
shall be touching the end of the inside of the glove. Fingernails will often protrude through the 
end of the finger glove, which is normal.  
S14. Examine the trunk cable to ensure that it is connected securely to the CM-1500 display monitor 
and the wrist cuff. 

 
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S15. Connect both CM-1500 electrode array sets to the corresponding electrode lead cables 
protruding from the wrist cuff. The blue connector/electrode array set shall connect to the 
blue lead cable connector on the wrist cuff. The white connector/electrode array shall connect 
to the white lead cable connector on the wrist cuff. The lead cable connectors are shaped to 
match the electrode connectors- ensure connectors are properly aligned before inserting (DO 
NOT FORCE THE CONNECTION).  
5.3.3 
CM-1500 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. 
S16. Start the monitoring session by pressing “START” on the CM-1500 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. 
S17. 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 or sitting position. The baseline measurement will continue for a minimum of 5 minutes.   
S18. Immediately prior to the start of the hemodialysis procedure, the Investigator or designated 
study personnel will press the “MARK EVENT” button on the CM-1500 which will signify the 
start of the procedure on the device.  A message will appear informing the user that an event 
has been marked. 
S19. Continue the monitoring session during the hemodialysis session. Upon completion of the 
session, 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.  If the subject needs to move to a different location 
during the 10-minute post-hemodialysis monitoring period, the time of movement should 
be noted on the CRF.  
S20. 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”.  
S21. Document any observations or adverse events that occur throughout the entirety of the 
monitoring session. 
S22. After the monitoring session is stopped, remove the electrode array sets from the subject and 
dispose of the electrodes and wrist strap per site guidelines.  Wipe down wrist cuff and cables 
per the IFU for next subject use.  

 
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5.4 
REPEAT STUDY PROCEDURES AND STUDY COMPLETION 
Subjects will continue to be monitored at each of their next two (2) subsequent hemodialysis sessions.  
If the device is not available or the subject is unable to complete the monitoring session at the following 
hemodialysis session, the next available hemodialysis session will be acceptable, and the date of the last 
procedure and number of hemodialysis sessions in between monitoring sessions will be captured on the 
case report form.  All attempts should be made to complete the subject’s participation in the study 
within two (2) weeks of enrollment.   
For the remaining two monitoring sessions, the procedure will continue the same as previously 
performed.  After the third CM-1500 monitoring session is complete, the subject’s participation in the 
study is considered complete.  If the subject elects to withdraw from the study before completing their 
third monitoring session, or if 30 days have passed since the initial monitoring session, subject 
withdrawal will be captured on the case report form.  Additional subjects will be enrolled (up to 20) until 
15 complete data sets of three (3) monitoring sessions each have been complete. 
5.5 
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. 
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 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 and institutional procedures. The device should always be turned off 

 
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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 and 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 
hemodialysis procedure. 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 
hemodialysis 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 performing hemodialysis 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. 
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 hemodialysis 
procedure or study procedure, and outcome. These definitions are in the corresponding tables below. All 
adverse events related to the hemodialysis 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.  
 
 

 
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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 Hemodialysis or Study Procedure 
 
Relationship 
Description 
None 
Causal relationship can be ruled out 
Possible – Hemodialysis 
Procedure 
Causal relationship is reasonably possible to the hemodialysis 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 – Hemodialysis 
Procedure 
Causal relationship to the hemodialysis procedure is certain  
Yes – Study 
Procedure/Device 
Causal relationship to the study procedure and/or device is certain  
 
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 

 
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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 hemodialysis 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.  
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.  
 
 

 
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Table 5: Study Reporting Contacts 
Contact 
Contact Information 
Principal Investigator 
Jonathan Tolins, MD 
InterMed consultants 
6600 France Ave S, Suite 162 
Edina, MN 55435 
Jtolins@comcast.net 
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 hypothesis generating study; therefore, hypothesis testing will not be performed. The sample size 
of 15 subjects is empirically determined to be sufficient for an early-phase pilot study characterizing the 
performance of the Relative Index during a hemodialysis procedure. The results of the study will be used 
to help the Sponsor determine if an appropriately powered clinical study can be defined.  
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 
DESCIPTIVE STATISTICS 
Descriptive statistics will be calculated for all objectives 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.   

 
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9.5 
STATISTICAL ANALYSIS  
The data for this study will be summarized using descriptive statistics. There is no formal hypothesis 
testing planned. Point estimates and the corresponding confidence intervals will be presented for the 
statistical analysis.   
The primary evaluations pertaining to the performance of the CM-1500 device will examine the behavior 
the Relative Index value in accordance with subject outcomes and conditions that present during the 
hemodialysis sessions. Baseline performance of the CM-1500 device will be set in the Relative Index 
before the hemodialysis sessions.  The primary analysis will utilize the descriptive statistics to characterize 
the changes in the CM-1500 Relative Index during the hemodialysis sessions, comparing to the baseline 
values. The analysis, however, can include investigation into individual vital sign parameters that the CM-
1500 device (or another source) produces during a subject’s session or 10-minute post-dialysis 
observation period.  
The average of the Relative Index at baseline and each following hemodialysis sessions will be calculated 
first for the variability analysis.  The inter-subject (between subject) and intra-subject (within-subject) 
variability in the Relative Index changes across multiple hemodialysis sessions will be estimated using the 
variance component analysis through a random effects model that includes only subject and hemodialysis 
session as random effects. The variance and % coefficient of variation (%CV) will be computed for the 
components of between-subject and within-subject through the model.   
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 post-treatment forms with the corresponding subject ID 
number for each of the hemodialysis procedures. Any required data not collected as standard of care for 
the hemodialysis 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, 

 
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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 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).  

 
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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 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 
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