Clinical Evaluation of the Zynex Monitoring System, Model CM-1600
Phase: NA
Conditions: Fluid Loss
Sponsor: Zynex Monitoring Solutions

CLINIMARK Test Plan  
Clinical Evaluation of Zynex Monitoring System, Model CM-1600 
PR2022-516 
 
Clinimark 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Clinical Evaluation of the Zynex Monitoring System, Model CM-
1600 ID# PR 2022-516 
Principal Investigator: Arthur Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
PR# 2022-516 
SHEET   1   of   30 
REV 1 
 
Confidential & Proprietary to Clinimark, LLC. 
 
 
 
CLINICAL PROTOCOL 
PR 2022-516 
NCT#05740644 
12-JAN-2023 
 
 
 
 
 
 

CLINIMARK Test Plan  
Clinical Evaluation of Zynex Monitoring System, Model CM-1600 
PR2022-516 
 
Clinimark 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Clinical Evaluation of the Zynex Monitoring System, Model CM-
1600 ID# PR 2022-516 
Principal Investigator: Arthur Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
PR# 2022-516 
SHEET   2   of   30 
REV 1 
 
Confidential & Proprietary to Clinimark, LLC. 
COMMERCIAL SPONSOR: 
Zynex Monitoring Solutions 
9555 Maroon Circle 
Englewood, Colorado 80112 
 
 
Document 
Ownership: 
Document is in accordance with Code of Federal Regulations for Non-Significant Risk Investigations and 
ISO 14155 where applicable. 
 
Function, Title 
Name 
Signature 
Date 
Special Clinical Studies 
Manager 
Anne Fedor 
 
12 JAN 2023 
 
 
Document 
Approver: 
 
 
 
 
Function, Title 
Name 
Signature 
Date 
Clinimark, Chief Clinical 
Officer 
Paul Batchelder 
 
12 JAN 2023 
Clinimark, Chief Technical 
Officer 
Dena Raley 
 
12 JAN 2023 
Zynex Representative 
Laura Seiberlich 
 
13 JAN 2023 
Revision 
History: 
Revision 
Date 
Revision Description 
Version 1 
12 JAN 2023 
Original issue 
 
Author:  
Blaire Ferguson, RN BSN 
 
 
Clinical Research Nurse 
CLINIMARK Laboratories 
Avista Adventist Hospital Plaza 
80 Health Park Drive Suite 20 
Louisville, CO 80027 
 
 
 

CLINIMARK Test Plan  
Clinical Evaluation of Zynex Monitoring System, Model CM-1600 
PR2022-516 
 
Clinimark 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Clinical Evaluation of the Zynex Monitoring System, Model CM-
1600 ID# PR 2022-516 
Principal Investigator: Arthur Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
PR# 2022-516 
SHEET   3   of   30 
REV 1 
 
Confidential & Proprietary to Clinimark, LLC. 
ETHICS COMMITTEE REVIEW: 
Salus Institutional Review Board 
2111 West Braker Lane, Suite 100 Austin, TX 78758 
 
STUDY PROCEDURE: 
 
Clinical Evaluation of the Zynex Fluid Monitoring System (CM-1600)  
Clinimark Study ID# PR 2022-516 
 
COMMERCIAL SPONSOR: 
Zynex Monitoring Solutions 
9555 Maroon Circle 
Englewood, Colorado 80112 
 
PRINCIPAL INVESTIGATOR:  
 
Arthur Cabrera, MD 
Avista Adventist Hospital, Staff Anesthesiologist 
100 Health Park Drive 
Louisville, CO 80027 
 
SUB-INVESTIGATORS  
Paul Batchelder, LRCP, RRT 
 
 
Dena Raley, BS Bio-Engineer 
  
Clinimark, CCO 
 
 
 
Clinimark, CTO 
Clinimark LLC. Business Address 1923 Pinal Road, Golden, Colorado 80401 
 
MEDICAL OVERSIGHT 
Arthur Cabrera, MD 
Avista Adventist Hospital, Staff Anesthesiologist 
100 Health Park Drive 
Louisville, CO 80027 
 
STUDY SITE: 
Clinimark, Site ID# 001   303 717-4820 
Avista Adventist Hospital Plaza 
80 Health Park Drive Suite 20 
Louisville, CO 80027 
 
CONFIDENTIALITY: 
This document is 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 will not disclose the information contained herein to others without 
the prior written consent of Zynex. 
 
IMPARTIALITY: 
Clinimark is committed to maintaining impartiality of laboratory and study activities. Personnel are trained on 
processes, and protocols are followed to ensure conformity of the activities. Commercial, financial, and other 
pressures are not allowed to compromise the impartiality of laboratory activities. This includes those risks that 
arise from lab activities, lab relationships, or from the relationships of its personnel. The risk of impartiality is 
mitigated by conducting this study according to the mutually agreed upon protocol, contractual arrangements, and 
standards, or guidance documents if applicable.  
 

CLINIMARK Test Plan  
Clinical Evaluation of Zynex Monitoring System, Model CM-1600 
PR2022-516 
 
Clinimark 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Clinical Evaluation of the Zynex Monitoring System, Model CM-
1600 ID# PR 2022-516 
Principal Investigator: Arthur Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
PR# 2022-516 
SHEET   4   of   30 
REV 1 
 
Confidential & Proprietary to Clinimark, LLC. 
 
Table of Contents 
Table of Contents .......................................................................................................................................................... 4 
Summary ........................................................................................................................................................................ 7 
Objectives of the Clinical Investigation Plan .............................................................................................................. 7 
Background ................................................................................................................................................................ 7 
Protocol Overview ..................................................................................................................................................... 8 
Study Population ....................................................................................................................................................... 9 
Inclusion Criteria .................................................................................................................................................... 9 
Exclusion Criteria ................................................................................................................................................... 9 
Duration of Clinical Investigation............................................................................................................................. 10 
Identification and Description of the Investigational Device .................................................................................. 10 
Data Acquisition System for the Investigational Device .......................................................................................... 11 
Reference Equipment .............................................................................................................................................. 12 
Safety Equipment .................................................................................................................................................... 12 
Preliminary Investigations and Justifications of the Study .......................................................................................... 12 
Risks and Benefits of the Investigational Device and Clinical Investigation ................................................................ 12 
ECG / Gel Electrodes ................................................................................................................................................ 13 
Pulse Oximetry Sensor ............................................................................................................................................. 13 
Finger Prick Lancet ................................................................................................................................................... 13 
Peripheral Intravenous Cannula .............................................................................................................................. 13 
Benefits .................................................................................................................................................................... 13 
Design of the Clinical Investigation .............................................................................................................................. 14 
Study Flow Chart ...................................................................................................................................................... 14 
Method .................................................................................................................................................................... 15 
Reference Equipment .............................................................................................................................................. 16 
Safety Equipment .................................................................................................................................................... 16 
Procedure .................................................................................................................................................................... 16 
Statistical Analysis ....................................................................................................................................................... 18 
Sample Size Justification .......................................................................................................................................... 18 
Investigational Review Board (IRB)/Independent Ethics Committee (IEC) .................................................................. 19 
Monitoring Arrangements ........................................................................................................................................... 19 
Monitoring Plan ....................................................................................................................................................... 20 
Data and Quality Management / Confidentiality ........................................................................................................ 20 
Records - Study Documentation / Case Report Forms ............................................................................................ 21 
Participant Documents ............................................................................................................................................ 21 
Data Collection Forms / Case Report Forms ............................................................................................................ 21 
Trial Master File Documents .................................................................................................................................... 21 
Amendments to the Clinical Investigation Plan ....................................................................................................... 22 
Deviations from the Clinical Investigation Plan ....................................................................................................... 22 
Device Accountability .............................................................................................................................................. 22 
Packaging and Labeling ............................................................................................................................................ 22 
Storage and Accountability ...................................................................................................................................... 23 
Statement of Compliance ............................................................................................................................................ 23 
Reference Documents ......................................................................................................................................... 23 

CLINIMARK Test Plan  
Clinical Evaluation of Zynex Monitoring System, Model CM-1600 
PR2022-516 
 
Clinimark 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Clinical Evaluation of the Zynex Monitoring System, Model CM-
1600 ID# PR 2022-516 
Principal Investigator: Arthur Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
PR# 2022-516 
SHEET   5   of   30 
REV 1 
 
Confidential & Proprietary to Clinimark, LLC. 
Informed Consent Process ........................................................................................................................................... 24 
Safety ........................................................................................................................................................................... 24 
Investigators ........................................................................................................................................................ 24 
Participant ........................................................................................................................................................... 24 
Adverse Event Definitions.................................................................................................................................... 24 
Management of Adverse Event Reporting .............................................................................................................. 25 
Reporting of Serious Adverse Events and / or UADE ............................................................................................... 26 
Sponsor Records and Reports ...................................................................................................................................... 26 
Records 21 CFR 812.140 (b) 4,5 ........................................................................................................................... 26 
Reporting 21 CFR 812.150 (b) 1,2,3,5,6,7,8,9,10: ................................................................................................ 26 
Unanticipated Adverse Device Effect .................................................................................................................. 26 
Withdrawal of IRB approval ................................................................................................................................. 26 
Withdrawal of FDA approval ............................................................................................................................... 27 
Progress Reports .................................................................................................................................................. 27 
Recall and device ................................................................................................................................................. 27 
Final Report ......................................................................................................................................................... 27 
Informed consent ................................................................................................................................................ 27 
Significant risk device determinations – (does not apply to NSR studies) ........................................................... 27 
Other .................................................................................................................................................................... 27 
Investigators Records and Reporting ....................................................................................................................... 27 
Records 21 CFR 812.140 (a)(3)(i) ......................................................................................................................... 27 
Reports 21 CFR 812.150 (a) 1,2,5,7 ..................................................................................................................... 27 
Unanticipated adverse device effects ................................................................................................................. 27 
Withdrawal of IRB approval ................................................................................................................................. 27 
Informed consent ................................................................................................................................................ 28 
Other .................................................................................................................................................................... 28 
Withdrawal, Early Termination, or Suspension of the Investigation ....................................................................... 28 
Publication Policy ..................................................................................................................................................... 29 
Attachment A - Protocol Signature Page ..................................................................................................................... 30 
 
 
 

CLINIMARK Test Plan  
Clinical Evaluation of Zynex Monitoring System, Model CM-1600 
PR2022-516 
 
Clinimark 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Clinical Evaluation of the Zynex Monitoring System, Model CM-
1600 ID# PR 2022-516 
Principal Investigator: Arthur Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
PR# 2022-516 
SHEET   6   of   30 
REV 1 
 
Confidential & Proprietary to Clinimark, LLC. 
Table 1: List of Abbreviations and Definitions of Terms 
Abbreviation/Term 
Definition 
AE 
Adverse Event 
ANP 
Atrial Natriuretic Peptide 
BI 
Bioelectrical Impedance 
BNP 
Brain Natriuretic Peptide 
BP 
Blood Pressure 
CM-1600 
Zynex Non-invasive Monitoring System CM-1600 
CBV 
Central Blood Volume 
CRF 
Case Report Form 
CS 
Clinically Significant 
ECG 
Electrocardiogram 
cGMP 
Cyclic Guanosine Monophosphate 
H 
Hypotensive Prone 
HD 
Hemodialysis 
HR 
Heart Rate 
ICW 
Intracellular Water Changes 
IRB 
Institutional Review Board 
kg 
Kilogram 
L 
Liter 
lb 
Pound 
LBNP 
Lower Body Negative Pressure 
mg 
Milligram 
mL 
Milliliter 
NCS 
Not Clinically Significant 
N 
Non-hypotensive Prone 
NSR 
Non-Significant Risk 
PO 
Pulse Oximetry 
PPG 
Photoplethysmography 
RH 
Relative Humidity 
SAE 
Serious Adverse Event 
SR 
Significant Risk 
TBI 
Total Body Impedance 
TI 
Thoracic Electrical Impedance 
ZMS 
Zynex Monitoring Solutions 
 
 
 
 
 
 
 
 
 
 

CLINIMARK Test Plan  
Clinical Evaluation of Zynex Monitoring System, Model CM-1600 
PR2022-516 
 
Clinimark 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Clinical Evaluation of the Zynex Monitoring System, Model CM-
1600 ID# PR 2022-516 
Principal Investigator: Arthur Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
PR# 2022-516 
SHEET   7   of   30 
REV 1 
 
Confidential & Proprietary to Clinimark, LLC. 
Summary 
 
Objectives of the Clinical Investigation Plan 
The objective of this study is to determine if manual blood loss of up to 500mL of blood and saline re-infusion can 
be identified using the non-invasive Zynex Monitoring System, Model CM-1600. 
 
Background 
The CM-1600 is a non-invasive monitoring system which detects changes in fluid volume.  Changes in extremity 
blood volume are indicative of central blood volume changes such as might occur during hemorrhagic events.  The 
CM-1600 uses an algorithm to process multiple parameters (electrical bioimpedance, heart rate, ECG amplitude, 
PPG amplitude, and skin temperature), collected via a wearable worn on the wrist and electrodes placed on the 
left ventral forearm and below the left clavicle. Development and refinement of these multiple parameters in a 
pre-established algorithm is necessary to correlate physiologic changes with signal events. This requires ongoing 
human clinical trials of both proxies of blood volume loss (e.g., cuff occlusion studies, decompression chamber 
studies) as well as actual phlebotomy blood draws under controlled conditions. 
 
Precedents for such studies exist in the literature. Cai et al. (2000) found that the correlation between intracellular 
water changes (ICW) in the thorax and heart erythrocyte volume was 0.84 (p < 0.05). These results suggest that 
changes in a human heart’s blood volume during lower body negative pressure (LBNP) can be extrapolated by 
determining thoracic electrical admittance of intracellular water. 
 
Krantz et al. (2000) considered that while cardiovascular variables remain relatively stable during minor 
hemorrhage, thoracic electrical impedance could serve as a non-invasive monitor of a volume deficit. They found 
that during hemorrhage and re-transfusion in a halothane anesthetized pig, a change in the magnitude of thoracic 
electrical impedance appears to be an accurate and non-invasive monitor of a blood volume deficit. They bled 10 
pigs (0-24 mL/kg) and re-transfused (to 28 mL/kg) during halothane anesthesia. The electrical impedance, 
cardiovascular parameters, blood gas, temperature, atrial natriuretic peptide, and near infrared spectroscopy of 
the leg muscles were recorded. During hemorrhage and re-transfusion, the median correlations between changes 
in the magnitude of the thoracic impedance and the external blood loss ranged from 0.97-0.98 with an individual 
range from 0.80-1.0. These correlation coefficients were higher and their ranges were narrower than correlations 
established for any other measured parameter. 
 
Perko et al. (2001) evaluated whether electric impedance can be used to monitor body fluid balance and fluid 
distribution in a prospective clinical study in 16 consecutive patients scheduled for cardiac surgery. Body weight, 
fluid balance, central hemodynamics, and total and segmental body impedance were examined perioperatively. 
After surgery, weight and fluid balance increased by 3.87 ± 0.35 kg and 1.86 ± 0.16 L (mean ± SE, p < 0.01) and 
remained elevated through the next 2 days. Impedance decreased by 4% over the entire body. Changes in total 
impedances had a high correlation to the fluid balance (r = -0.86). After correction of impedance values by the 
constant from the regression model, the mean difference in estimation of fluid changes obtained by electric 
impedance and by fluid balance was 0 ± 0.1 L at the range of changes of 4.6 L. This study suggests that alterations 
in electric impedance closely follow changes in fluid balance during the perioperative period. 
 
Cai et al. (2002) used thoracic electrical impedance (TI) to monitor the central blood volume and see if it could be 
used to predict hemodialysis (HD)-induced hypotension. In 12 hypotensive prone (H) and 13 non-hypotensive 
prone (N) patients, total body impedance (TBI) was followed every 10 minutes. TBI increased in all patients, and 
the increase was similar (60 ± 5 and 56 ± 6 Ω in H and N patients, respectively). The results suggest that TBI can be 
correlated with changes in blood volume, and that HD is associated with a reduction in the central blood volume. 
 
Ishibe et al. (2004) carried out a review of methods of assessment of volume status and found that determining 
dry weight and assessing extracellular fluid volume in HD patients is one of the greatest challenges for 
nephrologists. Biochemical markers of volume overload (ANP, BNP, cGMP) are fraught with excessive variability 

CLINIMARK Test Plan  
Clinical Evaluation of Zynex Monitoring System, Model CM-1600 
PR2022-516 
 
Clinimark 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Clinical Evaluation of the Zynex Monitoring System, Model CM-
1600 ID# PR 2022-516 
Principal Investigator: Arthur Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
PR# 2022-516 
SHEET   8   of   30 
REV 1 
 
Confidential & Proprietary to Clinimark, LLC. 
and poor correlation with volume status. Inferior vena cava ultrasound is effective, but cumbersome and costly. 
Bio-impedance measurements of intra- and extracellular water have significant shortcomings when used as 
isolated measurements but can be useful in following trends over time and have been shown to improve 
intradialytic symptoms and blood pressure control. Continuous blood volume monitoring is helpful in preventing 
intradialytic hypotension and may help identify patients who are volume overloaded and need increased 
ultrafiltration.  
 
Matzen et al. (1991) evaluated blood volume distribution during head-up tilt-induced central hypovolemia. To 
accomplish this, they evaluated regional electrical impedance (Z degree) at 2.5 and 100 kHz to separate intra- and 
extracellular fluid changes and correlated Z degree over the thorax (TI) to relative changes in the central blood 
volume (CBV) induced by head-up tilt. The results suggest that: (1) Hypovolemic shock is associated with a faster 
increase of TI than normotensive head-up tilt. (2) Head-up tilt is characterized by an initial decrease in CBV 
followed by a further decrease in plasma volume, which eventually leads to hypovolemic shock. (3) Blood volume 
changes during head-up tilt are reflected in regional Z degree. 
 
Perko et al. (1993) used regional electrical impedance over eight sections of the human body (two thoracic; one 
abdominal; two thighs; two around the knee; and one lower leg) to determine the volume indifference point 
during passive head-up tilt in 8 participants. Head-up tilt was performed in 10-degree increments from 0-60 
degrees over 6 min. Electrical impedance increased over the thorax in proportion to the head-up tilt angle, while 
abdominal impedance did not change significantly, and over the thigh and the lower leg it decreased with 
increasing head-up tilt angle. No change in electrical impedance was noted just above the knee, and electrical 
impedance just below the knee decreased only marginally. Results demonstrate minimal fluid accumulation 
around the knee during head-up tilt. Furthermore, in humans the electrical impedance (and therefore, probably 
the volume indifference point) is positioned between the umbilicus and crista iliaca. 
 
Protocol Overview 
This is a prospective, single-arm, non-randomized, non-controlled single-center study for the evaluation of the 
Zynex CM-1600 in 20 healthy adults undergoing a manual blood loss of up to 500mL followed by an infusion of 1 
liter of normal saline. 
 
After IRB Approval, 20 volunteer participants, ages 18 years and older with a range of physiques and skin tones, 
will be entered into a study that is designed to investigate the Zynex CM-1600 non-invasive monitoring system.  
Participants will be selected for the study using the inclusion / exclusion criteria.  After signing the informed 
consent, participants will complete a health assessment form and undergo a brief health screening.  
 
Each participant will be offered oral fluids and be fitted with non-invasive electrodes and a wrist wearable.  The 
participant will lie supine during the blood draw procedure.  Up to 10% of the participant’s total blood volume or 
up to 500mL (whichever is least) of blood will be drawn by a qualified medical professional under normal 
conditions.  A participant’s total blood volume is calculated: 
 
- 
Females:  
Weight in kilograms x 65  = Total blood volume 
- 
Males:   
Weight in kilograms x 75  = Total blood volume 
 
The CM-1600 will electronically record bioelectrical impedance (ohms), heart rate, skin temperature (°C), ECG 
amplitude, and PPG amplitude before, during, and after the blood draw. 
  
No passing criterion exists for this study.  This is an investigative study to collect preliminary data on healthy 
human volunteers. 
 
 
 

CLINIMARK Test Plan  
Clinical Evaluation of Zynex Monitoring System, Model CM-1600 
PR2022-516 
 
Clinimark 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Clinical Evaluation of the Zynex Monitoring System, Model CM-
1600 ID# PR 2022-516 
Principal Investigator: Arthur Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
PR# 2022-516 
SHEET   9   of   30 
REV 1 
 
Confidential & Proprietary to Clinimark, LLC. 
Study Population 
The study population will include 20 healthy adults, aged 18 and older with a variety of physiques and skin tones. 
The participants must understand the study and agree to participate by signing the informed consent. The 
participants must be healthy, showing no evidence of medical problems as indicated by satisfactory completion of 
the health assessment form and passing the health screening. Eligible participants need to meet all of the inclusion 
criteria and none of the exclusion criteria for participation. 
 
Inclusion Criteria 
• 
Participant must have the ability to understand the parameters of participation and provide written 
informed consent 
• 
Male or female of any race 
• 
Participant is adult 18 or older 
• 
Participant must be willing and able to comply with study procedures and duration 
• 
In the Principal Investigator’s medical judgment, the participant is suitable for a blood draw of up to 
500mL 
• 
Participant must weigh at least 110 pounds  
 
Exclusion Criteria 
• 
Any upper extremity amputation 
• 
Females who are pregnant, who are trying to get pregnant, or have a urine test positive for pregnancy on 
the day of the study   
• 
Participant has a heart condition that may interfere with the Zynex CM-1600 (e.g., pacemakers, 
defibrillator, irregular heartbeat, dextrocardia, etc.) 
• 
Participant has been diagnosed with chronic fatigue syndrome (also known as chronic fatigue, immune 
dysfunction syndrome, or myalgic encephalomyelitis)   
• 
Participant requires equipment and/or devices that may interfere with the Zynex CM-1600 (e.g., life-
sustaining equipment, other monitoring devices, insulin pumps, or other implanted devices) 
• 
Participant is taking coumadin (warfarin), heparin, or other prescription blood thinners for 7 or more days 
prior to blood draw 
• 
Participant donated blood within 8 weeks prior to the study blood draw 
• 
Participant has high or low blood pressure on the day of blood draw (high blood pressure is defined as 
systolic > 180 mmHg or diastolic > 100 mmHg; low blood pressure is defined as systolic < 100 mmHg or 
diastolic < 60 mmHg) 
• 
Participant has symptoms of an active infection or a temperature  100 F 
• 
Female with hemoglobin levels of less than 12.1g/dL or male with hemoglobin levels of less than 13.8g/dL 
• 
Participants with self-reported heart or cardiovascular conditions such as:  
o 
History of cardiovascular surgery 
o 
History of chest pain (angina) 
o 
Heart rhythms other than a normal sinus rhythm or respiratory sinus arrhythmia  
o 
History heart attack/myocardial infarction 
o 
Peripheral arterial disease 
o 
Carotid artery disease 
o 
Unexplained shortness of breath 
o 
Congestive heart failure (CHF) 
o 
History of stroke/transient ischemic attack 
o 
Myocardial ischemia 
o 
Cardiomyopathy 
o 
Dextrocardia 
• 
Participants with clotting disorders such as: 
o 
Hemophilia 

CLINIMARK Test Plan  
Clinical Evaluation of Zynex Monitoring System, Model CM-1600 
PR2022-516 
 
Clinimark 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Clinical Evaluation of the Zynex Monitoring System, Model CM-
1600 ID# PR 2022-516 
Principal Investigator: Arthur Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
PR# 2022-516 
SHEET   10   of   30 
REV 1 
 
Confidential & Proprietary to Clinimark, LLC. 
o 
History of blood clots 
o 
History of bleeding problems 
o 
Bruises easily 
• 
Self-reported health conditions as identified in the Health Assessment Form including: 
o 
Diabetes 
o 
Uncontrolled thyroid disease 
o 
Kidney disease / chronic renal impairment 
o 
History of seizures (except childhood febrile seizures) 
o 
Epilepsy 
o 
History of unexplained syncope 
o 
Recent history of frequent migraine headache within the last 2 months 
o 
Recent head injury within the last 2 months 
o 
History of cancer, with or without chemotherapy within the last 2 months 
• Other known health conditions deemed unsuitable for participation by the PI when considered upon 
disclosure on health assessment form 
 
Duration of Clinical Investigation 
It is expected that the data collection for the study will take approximately 8 working days to complete. Individual 
subject participation is expected to take approximately 3 hours. No additional follow-up is required for the 
investigation. 
 
Identification and Description of the Investigational Device 
The Zynex CM-1600 was developed to provide physicians with a non-invasive way to detect and monitor changes 
in volume, particularly when fluctuations are anticipated, such as during surgery, in post-op and/or recovery. This 
monitoring device will identify baseline subject status and detect relative changes using an algorithm to compare 
and review data trends monitored during surgery, displaying blood volume and blood loss in real-time. 
 
  
 
Figure 1. Placement of the electrodes and wearable on participant.  
 
 
 
 

CLINIMARK Test Plan  
Clinical Evaluation of Zynex Monitoring System, Model CM-1600 
PR2022-516 
 
Clinimark 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Clinical Evaluation of the Zynex Monitoring System, Model CM-
1600 ID# PR 2022-516 
Principal Investigator: Arthur Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
PR# 2022-516 
SHEET   11   of   30 
REV 1 
 
Confidential & Proprietary to Clinimark, LLC. 
The design configuration for the Zynex CM-1600 includes: 
• 
Compact, all-inclusive unit with display, touch-screen, and electronics 
• 
Power supply 
• 
Wearable  
• 
Wrist strap 
• 
Y-Cable 
• 
Electrodes 
 
Displayed on the screen are: 
• 
Bioelectrical impedance (ohms) 
• 
Heart rate 
• 
ECG amplitude 
• 
PPG amplitude 
• 
Skin temperature (°C) 
 
The values from these parameters become algorithm inputs, which calculate a Relative Index of changes in patients, 
and a trend graph displays corresponding patient status. The trending graph starts at 100 (baseline data point) and 
plots changes relative to blood loss. 
 
The CM-1600 is manufactured by Zynex Monitoring Solutions (ZMS). The company maintains a quality system 
compliant with ISO 13485:2016, Medical Devices -- Quality Management Systems -- Requirements for Regulatory 
Purposes.  The CM-1600 and the enclosed electronics have passed all cleaning and disinfection, biocompatibility, 
electrical safety, and electromagnetic compatibility testing required for cardiac monitoring devices. Materials are 
certified to comply with standard material specifications.  Formal design of the ZMS CM-1600 was conducted in 
accordance with the current Good Manufacturing Practices (GMP) requirements set forth in the Quality System 
Regulations (QSR) promulgated under Section 520(f) of the Food, Drug, and Cosmetic (FD&C) Act; design control 
procedures under 21 CFR §820 and ISO 13485; other applicable national and international standards and guidance 
as appropriate; and Zynex’s own product specifications and technical drawings, and within the context of the 
company’s design controls and Medical Device File (MDF) that fall under its QMS. 
 
FDA guidance documents, ISO standards, and additional design related documents, including the Device Master 
Record (DMR)/Medical Device File (MDF), and Device History Record (DHR) reside with ZMS and are available upon 
request.  
 
Data Acquisition System for the Investigational Device 
The data will be collected by the Zynex CM-1600 non-invasive monitoring system.  
 
MediCollector 
• 
Computer with data collection software, able to stream data as it is recorded with the ability to add 
annotations 
• 
Direct cable connection with the Datex-Ohmeda S/5 Multi-parameter Monitor 
• 
Collects a variety of signals including values displayed by the S5 as well as the raw waveforms 
o 
Up to 8 signals can be collected 
 
MediCollector –Signal Channels Examples 
# 
Name 
Description 
Freq. of 
Collection (Hz) 
Units 
1 
SpO2 
Oxygen Saturation 
0.2 
% 
2 
SpO2_Pulse 
Pulse Rate from SpO2 
0.2 
beats/min 
3 
CO_RR 
Respiratory Rate 
0.2 
breaths/min 
4 
HR_ECG 
Heart Rate from ECG 
0.2 
beats/min 

CLINIMARK Test Plan  
Clinical Evaluation of Zynex Monitoring System, Model CM-1600 
PR2022-516 
 
Clinimark 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Clinical Evaluation of the Zynex Monitoring System, Model CM-
1600 ID# PR 2022-516 
Principal Investigator: Arthur Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
PR# 2022-516 
SHEET   12   of   30 
REV 1 
 
Confidential & Proprietary to Clinimark, LLC. 
 
 
Reference Equipment 
• 
GE Healthcare (Datex-Ohmeda) S5 Compact Monitor (K061185) with M-NESTPR (K993608) or E-PRESTN 
(K031781) module, and/or other multi-parameter monitor (or equivalent) for ECG /heart rate/SpO2 
/respiratory rate monitoring 
• 
Clinimark data collection system 3900 TruTrak+  
• 
CO-Oximeter: ABL 80 OSM or equivalent (optional) 
• 
Abbott iStat 1 or equivalent (optional) 
 
Safety Equipment 
• 
Portable oxygen tank, mask, and ambu bag 
• 
Blood pressure cuff and stethoscope 
• 
Temperature probe 
 
Preliminary Investigations and Justifications of the Study 
• 
Clinical Evaluation of the Zynex Monitoring System (CM-1600) PR 2022-516.   
 
Most existing methods for monitoring central filling pressures, which serve as an estimation of blood volume, involve 
invasive intravascular monitoring, such as pulmonary artery-, central venous-, and intra-arterial catheters.  These 
invasive monitors carry a substantial complication risk. Conversely, the Zynex CM-1600 non-invasively monitors 
blood volume and blood loss. 
This non-invasive monitoring device will identify baseline physiological parameters and calculate relative changes in 
blood volume using an algorithm to compare and review patient data acquired in real-time. The device will 
immediately display relative changes in blood volume. The ability to continuously detect changes in relative blood 
volume will enable appropriate fluid management peri-operatively.  Optimum fluid balance improves patient 
stability, minimizes complications, and diminishes surgical trauma and recovery time, thereby improving overall 
patient outcomes. 
 
 
Risks and Benefits of the Investigational Device and Clinical Investigation 
The device under test in this study is considered a non-significant risk device.  
 
Participants engaging in this study are subject to risks that are no greater than, or are similar to, the risks 
associated with undergoing a blood donation. The risks of blood donation include nausea, lightheadedness, and 
dizziness, which are temporary and usually brief. The CM-1600 non-invasively monitors and records bioelectrical 
impedance (ohms), heart rate, ECG amplitude PPG amplitude, and skin temperature (°C). 
 
The device and use of the device under test does not meet the definition of significant risk device under 21 CFR 
812.3(m). For the purpose of this study: 
• 
It is not intended as an implant. 
o 
Sensors are superficially applied to the site and are removed following data collection (less than 
1 day). 
• 
It is not purported or represented to be for use in supporting or sustaining human life, nor does it present 
a potential for serious risk to the health, safety, or welfare of a participant.  
o 
See below for discussion of risk associated with the device and use of the device. 
• 
It is not for use of substantial importance in diagnosing, curing, mitigating, or treating disease, or 
otherwise preventing impairment of human health.  

CLINIMARK Test Plan  
Clinical Evaluation of Zynex Monitoring System, Model CM-1600 
PR2022-516 
 
Clinimark 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Clinical Evaluation of the Zynex Monitoring System, Model CM-
1600 ID# PR 2022-516 
Principal Investigator: Arthur Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
PR# 2022-516 
SHEET   13   of   30 
REV 1 
 
Confidential & Proprietary to Clinimark, LLC. 
 
No anticipated risks or adverse device effects need to be assessed. No contraindications exist for use in the 
proposed study / study population. Any other risks to the participant associated with the device or procedure  
are unforeseeable at this time.  
 
ECG / Gel Electrodes  
Materials (such as the adhesive and/or gel contact) used in the electrodes may cause some skin irritations in some 
participants. Typical skin irritations present with redness of skin and in some cases of sensitivity as an allergic 
reaction. Biocompatibility testing for surface contact electrodes is a requirement of the International Organization 
of Standardization (ISO) 10993-9:2008 Biological Evaluation of Medical Devices. The risk in the use of ECG and 
other gel electrodes is believed to be minimal. 
 
Pulse Oximetry Sensor 
Pulse oximetry sensor placement involves positioning pulse oximetry sensors on the volunteer participant in the 
same manner that is used on hospitalized patients.  The sensors may be warm to the touch. Under normal 
operating conditions, without electrical abnormalities or fault conditions, the sensors are not expected to 
overheat. If the sensors are too warm, they will be removed immediately.  Clip on and soft reusable sensors exert a 
minimal amount of pressure. They should not cause discomfort. Adhesive sensors or tape may cause some 
irritations to the skin in some participants. Every effort will be made to minimize products with natural rubber or 
latex, and products containing natural rubber or latex will be identified.  The risk involved in the use of pulse 
oximetry sensors is believed to be minimal. 
 
Finger Prick Lancet 
A finger prick blood analysis involves using a lancet to draw a small amount of blood from the tip of a finger.  
Possible risks from the finger prick procedure include: discomfort, bruising, clotting, and infection.  
 
Peripheral Intravenous Cannula  
A peripheral IV cannula will be inserted by a qualified healthcare professional. The possible risks from the IV 
insertion include: pain, hematoma, clotting, infection, scar formation, and infiltration.  
 
Benefits 
The benefits to the study are to the advancement of non-invasive medical monitoring of patients by improving 
accuracy and performance of the monitors. Other than being a paid volunteer, no direct benefits to the 
participants engaging in this study exist. The only alternative to this study is to NOT participate. 
 
 

CLINIMARK Test Plan  
Clinical Evaluation of Zynex Monitoring System, Model CM-1600 
PR2022-516 
 
Clinimark 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Clinical Evaluation of the Zynex Monitoring System, Model CM-
1600 ID# PR 2022-516 
Principal Investigator: Arthur Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
PR# 2022-516 
SHEET   14   of   30 
REV 1 
 
Confidential & Proprietary to Clinimark, LLC. 
Design of the Clinical Investigation 
Study Flow Chart 
 
 
 
 
 
 
Participant Screening
• Participant Informed 
Consent
• Inclusion/Exclusion 
Criteria
• Medical, Meds, AE 
History
• Collect baseline vital 
signs
• Hemoglobin screening
During Study
•Fit CM-1600 to left arm 
and start monitoring 
session 
•Place nasal cannula
•Start IV (preferrably on left 
hand but either hand or 
either antecubital site is 
acceptable)
• Rest 5 minutes
• Passive leg raise above 
heart for 3 minutes
• Lower legs for 5 minutes
• Blood draw (right arm 
preferred)
• Wait 10 minutes
• Measure vital signs
• Saline Infusion (1 liter) 
over 30 - 60 minutes
• Provide PO fluids and 
snack
• Observe participant for 
30-60 minutes; document 
stable vital signs and ability 
to walk without 
compromise
After Study Completion
• Final measurement of 
vital signs
• Stop CM-1600 
monitoring session 
and all data collection 
• Remove CM-1600
• Remove IV and safety 
monitoring equipment
• Report any AEs/SAEs 
that occur after visit
• Follow-up with 
participant via phone 
within 24-48 hours.

CLINIMARK Test Plan  
Clinical Evaluation of Zynex Monitoring System, Model CM-1600 
PR2022-516 
 
Clinimark 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Clinical Evaluation of the Zynex Monitoring System, Model CM-
1600 ID# PR 2022-516 
Principal Investigator: Arthur Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
PR# 2022-516 
SHEET   15   of   30 
REV 1 
 
Confidential & Proprietary to Clinimark, LLC. 
 
Method 
This is a prospective, single-arm, non-randomized, non-controlled, single-center study for the evaluation of the 
Zynex CM-1600 in 20 healthy adults undergoing a manual blood loss of up to 500mL (or 10% BV) and saline re-
infusion.  Each participant test is expected to take approximately 2.5-3 hours. The overall data collection process is 
expected to be completed in approximately 8 working days.  
 
The objective of this study is to determine if manual blood loss of up to 500mL of blood and re-infusion of saline 
can be identified using the non-invasive Zynex CM-1600. 
 
The procedure will be explained to the volunteer, and if he/she agrees to participate, he/she will then sign the 
informed consent. The participant shall also complete a health screening form, which will be reviewed by a 
clinician before the test begins. 
 
Participants will lie supine for the application of the devices and for the remainder of the study.  Hemoglobin will 
be measured for inclusion screening with either a finger prick or venous blood draw.   
 
In addition to the study device, a multi-parameter monitor will be utilized to monitor heart rate, cardiac rhythm, 
blood pressure (not continuously), pulse rate, respiratory rate, and SPO2 for safety during the test. These 
observations will be monitored throughout the study, both objectively and subjectively. Should vital signs become 
unstable, per the clinical judgment of the study staff, the study will be halted immediately. 
 
During the study, data will be continuously recorded electronically. Additional study notes describing conditions of 
the test, deviations, device issues, and any adverse events will be documented in writing. 
 
Photographs may be taken of the sensor application sites prior to and post sensor application for data collection 
and analysis purposes and the Sponsor’s internal research and development only.  Photos may include the upper- 
and lower body or any other site where equipment has been placed. In order to capture images of the study 
equipment, it may be unavoidable to photograph the participant’s face.  In order to protect his/her identity, that 
person’s name and all personal identifiers will be kept confidential at all times.   
 
If the participant refuses to be photographed, it may affect his/her ability to participate in the study. 
 
 
 

CLINIMARK Test Plan  
Clinical Evaluation of Zynex Monitoring System, Model CM-1600 
PR2022-516 
 
Clinimark 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Clinical Evaluation of the Zynex Monitoring System, Model CM-
1600 ID# PR 2022-516 
Principal Investigator: Arthur Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
PR# 2022-516 
SHEET   16   of   30 
REV 1 
 
Confidential & Proprietary to Clinimark, LLC. 
Reference Equipment 
• 
GE Healthcare (Datex-Ohmeda) S5 Compact Monitor with M-NESTPR (K993608) or E-PRESTN (K031781) 
module, and/or other multi-parameter monitor (or equivalent) for ECG /heart rate/SpO2 /respiratory rate 
monitoring 
• 
Clinimark data collection system 3900 TruTrak+  
• 
CO-Oximeter: ABL 80 OSM or equivalent (optional) 
• 
Abbott iStat 1 or equivalent (optional) 
 
Safety Equipment 
• 
Portable oxygen tank, mask, and ambu bag 
• 
Blood pressure cuff and stethoscope 
• 
Temperature probe 
Supplies for Participant  
• 
16-gauge needles for blood draw (other gauges as necessary) 
• 
Alcohol wipes 
• 
Blood collection bags 
• 
Anticoagulant coated tubing to decrease clotting  
• 
Nasal cannulas 
• 
1L bags of normal saline  
• 
18-, 20- and 22-gauge IV catheters 
• 
IV start kit 
 
Investigational Device 
• 
Zynex CM-1600 monitoring system 
 
 
Procedure 
1. Complete equipment set up and checkout prior to starting study.  
2. Set and / or synchronize the computer clocks for the CM-1600 and Clinimark data collection systems.  
3. Explain the procedure to the participant. Have him/her read the informed consent, review the 
information with the participant, and answer all questions. Once all questions have been answered, 
have the participant sign and date the informed consent. Each participant will be given a copy of the 
consent prior to release.  
4. Ask the participant to complete, sign, and date the Health Assessment Form. The clinician or PI will, 
together with the participant, review the information provided about his/her health history. Based on 
this review, the clinician will determine to accept or exclude the participant from the study. Continue 
if accepted into the study.  
5. Record participant number and demographic information on the Clinimark CRF and calculate the 
blood volume.  
6. Place the participant into supine position, apply reference ECG leads, and review for normal sinus 
rhythm or sinus arrhythmia.   
7. Take participant’s temperature to screen for potential infection prior to study start. 
8. Apply NIBP cuff and take reading.  
9. Apply PPG sensors and screen for safe SPO2 to participate in study. 
10. Perform hemoglobin inclusion screening. 
11. Apply nasal cannula.   
12. Cleanse participant’s skin with an alcohol wipe, and place the non-invasive electrode pads at 
participant’s left clavicle and left forearm. 
13. Set up CM-1600 (See IFUs for proper setup) and begin monitoring session.  
14. Verify communication between the devices and data collection system.  

CLINIMARK Test Plan  
Clinical Evaluation of Zynex Monitoring System, Model CM-1600 
PR2022-516 
 
Clinimark 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Clinical Evaluation of the Zynex Monitoring System, Model CM-
1600 ID# PR 2022-516 
Principal Investigator: Arthur Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
PR# 2022-516 
SHEET   17   of   30 
REV 1 
 
Confidential & Proprietary to Clinimark, LLC. 
15. Start IV (preferably on participant’s left hand but either hand or either antecubital site will be 
acceptable), using 20-22g IV catheter (or other appropriate size) and open line with saline at TKO.  
Press “Mark Event” on the CM-1600. 
16. Record device information for tracking (manufacturer, model number, serial/lot number, 
hardware/software control information).  
17. Participant will rest for 5 minutes while the baseline measurements are recording.  
18. After the 5-minute baseline recording is captured, passively raise the participant’s legs above his/her 
heart for 3 minutes and press “Mark Event” on the CM-1600 screen (Figure 2) when initiating.  
19. Passively lower the participant’s legs and press “Mark Event” on the CM-1600 when initiating 
lowering. 
20. Wait 5 minutes to return to baseline.  
21. Prepare for blood draw using 16g IV catheter (or other appropriate size) primarily from the right arm 
(left antecubital region is acceptable if right access is not attainable). Just before the blood draw (at 
needlestick), push the “Mark Event” button on the display.  
22. Perform blood draw of 10% of participant’s blood volume, up to 500mL, based on body weight and 
blood volume calculation.   
23. Immediately following completion of the blood draw (tubing clamped), press “Mark Event” on the 
CM-1600 screen.  
24. The participant will lie flat for at least 10 minutes while the CM-1600 is still running the monitoring 
session after the blood draw is complete.  
25. Infuse 1 liter of normal saline over 30 – 60 minutes through the IV. Push the “Mark Event” button on 
the screen at the beginning and end of the saline infusion.  
26. Measure vital signs: blood pressure, respiratory rate, ECG, SPO2, and heart rate. 
27. Offer oral fluids and a snack to the participant.  
28. Continue to monitor the participant for 30-60 minutes. 
29. Measure vital signs: blood pressure, respiratory rate, ECG, SPO2, and heart rate 
30. If normal vital signs are achieved / maintained; the participant is able to walk without compromise; 
and the participant is not experiencing difficulty eating or drinking, stop the CM-1600 monitoring 
session and all external reference devices, remove the IV, remove all devices from the subject, and 
clear the participant to leave. 
31. Review any final questions with the participant, and ask if there were any ill effects from the study.  
32. Give the participant final instructions for care of the IV site and the blood draw site. Provide phone 
numbers for questions pertaining to participation in this study, research-related injury, or any 
adverse reaction post study.  
33. Once data collection on the CM-1600 is stopped, the USB data storage can be removed. USB data 
storage device is to be labeled in accordance with the assigned participant identification number and 
the continuity of the acquired data is to be verified and/or backed-up. The CM-1600 device and 
accessories will be wiped down again with a disinfecting wipe. Electrodes will be disposed.  
34. Blood disposal will be carried out at the Investigator site and will follow all applicable rules and 
regulations, including any site-specific procedures. 
35. Clinimark will follow up with the participant in 24-48 hours to screen for any adverse events or 
complications. 
 
 
 

CLINIMARK Test Plan  
Clinical Evaluation of Zynex Monitoring System, Model CM-1600 
PR2022-516 
 
Clinimark 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Clinical Evaluation of the Zynex Monitoring System, Model CM-
1600 ID# PR 2022-516 
Principal Investigator: Arthur Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
PR# 2022-516 
SHEET   18   of   30 
REV 1 
 
Confidential & Proprietary to Clinimark, LLC. 
 
Figure 2. Start button indicated by green circle on monitor screen. Mark Event button indicated by red 
circle on monitor screen. 
 
 
 
Statistical Analysis  
This is a prospective, single-arm, hypothesis-generating study early in the clinical development of the Zynex CM-
1600; hence, no statistical tests are required and no assumptions are made.  Any statistical and data analysis will 
be performed by the Sponsor.   
 
Sample Size Justification 
The objective of this study is to determine if manually controlled and quantified blood loss and saline re-infusion 
can be identified by the non-invasive Zynex CM-1600. No statistical hypotheses have been generated for this 
study; therefore, the sample size of 20 participants is empirically determined to be sufficient for an early-phase 
hypothesis-generating study and is based on clinical judgment rather than statistical considerations. 
 
Analysis Populations 
This is a hypothesis-generating study of 20 participants; therefore, all data collected will be used and presented in 
the study summaries. 
 
Statistical Analysis Plan 
• 
The data for this study will be summarized using descriptive and frequency statistics, depending on the 
nature of the variable. The distribution of continuous variables will be summarized using number and 
percentage of non-missing data points, means, standard deviations (sd), medians, minimums, and 
maximums. Ordinal variables will be summarized using categorical methods if the number of observed 
responses is small (usually fewer than 4) and with medians, minimums and maximums otherwise. 
Summary statistics for discrete variables will consist of the numbers and percentages of responses in each 
category. 
 

CLINIMARK Test Plan  
Clinical Evaluation of Zynex Monitoring System, Model CM-1600 
PR2022-516 
 
Clinimark 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Clinical Evaluation of the Zynex Monitoring System, Model CM-
1600 ID# PR 2022-516 
Principal Investigator: Arthur Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
PR# 2022-516 
SHEET   19   of   30 
REV 1 
 
Confidential & Proprietary to Clinimark, LLC. 
• 
A descriptive analysis of the change from baseline will be performed to better understand the magnitude 
of the changes and variability of the measurements for bioelectrical impedance (ohms), heart rate, ECG 
amplitude, PPG amplitude, skin temperature (°C), to obtain the relative index (RI). 
 
• 
A correlation analysis will be performed to gain a basic understanding as to how the Zynex CM-1600 
measurements relate to the actual volume of blood loss and saline re-infusion. This is a hypothesis-
generating study and is not powered to establish a true relationship; therefore, the results of this analysis 
will not be presented with statistical significance. 
 
• 
Adverse events and concomitant medications that are reported during the study will be summarized and 
presented in a tabular format. 
 
• 
All available data will be presented and summarized based on the number of participants with available 
data. Missing data will not be imputed, as no statistical inferences will be made based on the results of 
these analyses. 
 
 
Investigational Review Board (IRB)/Independent Ethics Committee (IEC) 
Prior to the start of participant enrollment, the Primary Investigator will be responsible for obtaining approval from 
the authorized IRB/IEC for the institution at which the proposed clinical investigation is to be conducted. Written 
approval from the IRB/IEC should specifically refer to the Investigator, the protocol title and date, and participant 
informed consent date. Written IRB/IEC approval and any conditions of approval imposed by the IRB/IEC will be 
obtained by the Primary Investigator. 
 
Protocol amendments must also undergo IRB/IEC review and approval at each clinical site. The written approval 
from the IRB/IEC for the amendment should specifically refer to the Investigator, the protocol version number and 
title, and any amendment numbers that are applicable.  
 
The Investigator will ensure that this study is conducted in accordance with the principles of the Declaration of 
Helsinki. 
 
Monitoring Arrangements 
Zynex (Sponsor) or Clinimark personnel (Louisville, CO, USA) will provide all monitoring. The Monitor shall be 
responsible for maintaining a record of the findings, conclusions, and actions taken for the results of monitoring 
the study ensuring that: 
 
The monitoring requirements for an NSR device study is identified in 21 CFR 812.2(b) Abbreviated requirements. 
For monitoring an NSR device investigation, the requirement is to comply with 21 CFR 812.46 with respect to 
monitoring investigations: (a) Securing Compliance, (b) Unanticipated adverse device effects, (c) Resumption of 
terminated studies: 
• 
Compliance to the signed agreement between the Investigator and Sponsor 
• 
Follows the protocol and any amendments that apply 
• 
Compliance to any conditions of the approval imposed by the IRB or FDA 
 
Additionally:  
• 
The conditions for the study continue to be acceptable. 
• 
Accurate, complete, and current records are maintained, and required reports are written. 
• 
Any adverse effects are documented and reported to the Sponsor and IRB as appropriate. 
• 
Monitor activities may include, for example:  performing source data verification and requesting 
corrections to feedback forms where potential inconsistencies or missing values are identified. 

CLINIMARK Test Plan  
Clinical Evaluation of Zynex Monitoring System, Model CM-1600 
PR2022-516 
 
Clinimark 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Clinical Evaluation of the Zynex Monitoring System, Model CM-
1600 ID# PR 2022-516 
Principal Investigator: Arthur Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
PR# 2022-516 
SHEET   20   of   30 
REV 1 
 
Confidential & Proprietary to Clinimark, LLC. 
• 
Findings of non-compliance or required modifications are reviewed with the Investigator and the Sponsor, 
and is presented in a written report to both. 
• 
A monitoring report is provided at the end of the clinical investigation. 
 
 
Monitoring Plan 
 
1) Informed Consent 
• 
Verify that the consent was signed prior to any study procedures being conducted. 
• 
Verify that the staff conducting the consent is listed for approval on the Delegation of Authority Log. 
• 
Ensure that the consent process is documented. 
2) Participant Eligibility 
• 
Verify that the participant meets all of the inclusion criteria and none of the exclusion criteria. 
3) Baseline Data 
• 
Verify demographic information with the health assessment form. 
• 
Check that informed consent time and date is prior to start of the procedure. 
4) Verify that all CRFs are completed.  
5) Adverse Events 
• 
Verify that Adverse Events and Serious Adverse Events / UADEs are reported accordingly to the IRB and 
Sponsor in the required timeframe. 
6) Protocol Deviations 
• 
Verity that protocol deviations are reported accordingly to the IRB and Sponsor in the required 
timeframe. 
7) Electronic Data Review 
• 
Verify that the filename matches the filename entered on the CRF. 
8) Ensure that the Trial Master File is complete. 
 
 
Data and Quality Management / Confidentiality 
A checklist identifying the contents of the Trial Master File / Project folder PFC# 2022-516 will be maintained. 
 
The participant’s name and signatures will be recorded on the informed consent, health assessment form, and a 
participation list. The data collection form will only use a participant number for the day of the test along with 
participant demographics. A name will not be recorded on the case report form.  
 
Records identifying the participant’s name will be kept in a secured location with either a locked file or locked 
door.  Access to these files will be on a limited basis. Potential reviewers of this information include: Clinimark 
representatives collecting the information and conducting the study; Medical Director for Clinimark; the U.S. Food 
and Drug Administration (FDA); Department of Health and Human Services (DHHS) agencies; Governmental 
agencies in other countries; Salus Independent Review Board; and representatives of the Sponsor. This group may 
use the information to conduct independent audits and reviews to verify compliance of the regulatory 
requirements for these studies but not copy the information.  
 
Data files stored electronically will be associated with a participant based on participant identification number, 
date, and by filename recorded on the data collection forms. The original device electronic data files will be 
preserved in its original form. Data analysis will be performed as a separate electronic file.   
 
Data files, data collection records with participant demographics and participant number may be additionally 
copied (after de-identification, if applicable), reviewed, and supplied to the Sponsor for the study. 
 

CLINIMARK Test Plan  
Clinical Evaluation of Zynex Monitoring System, Model CM-1600 
PR2022-516 
 
Clinimark 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Clinical Evaluation of the Zynex Monitoring System, Model CM-
1600 ID# PR 2022-516 
Principal Investigator: Arthur Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
PR# 2022-516 
SHEET   21   of   30 
REV 1 
 
Confidential & Proprietary to Clinimark, LLC. 
All study records will be stored for at least 2 years post the release of the product or project cancellation. The 
Investigator will notify the Sponsor prior to destruction of study records.  Other storage arrangements may be 
executed per contractual agreement between the Sponsor and the Investigator.  
 
 
Records - Study Documentation / Case Report Forms 
CRF 2022-516 
  
Participant Documents 
Provided as separate documents to this protocol: 
• 
Informed consent (IRB approved) 
• 
Health Assessment Form (Clinimark Control # F2000-001-001 Rev 13 or current revision) 
 
Study Conduct Documents: 
• 
CRF2022-516– Case Report Forms 
• 
Electronic Files – electronic data collected from the devices under test or reference systems 
 
Data Collection Forms / Case Report Forms 
To ensure the quality and integrity of the data, it is the responsibility of the Investigator(s) or designee to complete 
the Case Report Forms (CRFs) for each participant enrolled in this study. In some cases, the data collection forms 
will also be the source document for some information that is not directly collected in the Health Assessment 
Form. The following information will be recorded on the site’s data collection forms (CRF): 
• 
Study date, participant identification number, relevant participant demographics, and associated 
electronic filename(s) 
• 
Evidence that informed consent was signed and dated prior to the participant participating in the study 
• 
Information for participant inclusion or exclusion to the study 
• 
Equipment calibration and communication check out  
• 
Device usage / sensor placement on the participant 
• 
Baseline respiration rate, SpO2, heart rate and rhythm, blood pressure, and pulse ox data  
• 
Annotations on data point markers, stability, and other observations used in the data analysis 
• 
Protocol deviation reporting (only if needed) 
• 
Adverse Events reporting (only if needed) 
• 
Study termination  
 
A black or blue pen will be used to record data on the data collection forms. Recorded information should be 
legible and complete. Erroneous entries should be crossed out, corrected with the change, and initialed and dated 
by the individual making the correction. The Investigator(s) or designee will sign and date at indicated places on 
the data collection form. The Protocol Deviations Report may be signed and dated by the designee, only if there 
are no deviations; otherwise, the Sub-Investigator or Investigator should review, sign, and date. The Adverse 
Events Report must be signed and dated by the designee and a Sub-Investigator or Investigator. The Principal 
Investigator must review, sign, and date all serious adverse events.  The Investigator or designee will provide a final 
signature indicating that a thorough inspection of all participant data has been performed and will thereby certify 
the contents of the forms. The Investigator’s Certification Statement will disclose the overall documentation, study 
oversight, and certification of the study.  If corrections are made after review and signature by the Principal 
Investigator, the Principal Investigator will be made aware of the changes, and his/her awareness will be 
documented by initialing and dating the changes. 
  
 
Trial Master File Documents 

CLINIMARK Test Plan  
Clinical Evaluation of Zynex Monitoring System, Model CM-1600 
PR2022-516 
 
Clinimark 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Clinical Evaluation of the Zynex Monitoring System, Model CM-
1600 ID# PR 2022-516 
Principal Investigator: Arthur Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
PR# 2022-516 
SHEET   22   of   30 
REV 1 
 
Confidential & Proprietary to Clinimark, LLC. 
• 
Clinimark Control # B3000-000-003 – Adverse Events and Protocol Deviation Reporting System  
• 
Clinimark Control # F2000-001-029 - Device Deficiency Form 
• 
Clinimark Control # F2000-001-016 - Device Accountability Form 
• 
Clinimark Control # F2000-001-015 - Delegation of Authority  
• 
Clinimark Control # F2000-001-017 - Investigator Financial Interest Disclosure 
• 
Clinimark Control # F2000-001-022 – Investigator’s Certification Statement 
• 
Clinimark Control # F2000-001-028 - Participant Enrollment Log 
• 
Clinimark Control # F2000-001-027 - Site Personnel Training Log 
• 
Clinimark Control # F2000-001-033 - Site Visit/ Monitoring Log 
• 
Clinimark Control # F2000-001-034 - Data Clarification Form 
• 
Clinimark Control # F2000-001-037 - Protocol Deviation Log 
• 
Clinimark Control # F2000-001-038 - Adverse Events Log 
• 
Clinimark Control # F2000-001-042 - Adverse Event CRF 
• 
Clinimark Control # F2000-001-043 - Protocol Deviation Form 
• 
Communications 
• 
Zynex Monitoring Solutions CM-1600 Instructions for Use (Rev 6) 
  
Current revision of documents applies. 
 
Amendments to the Clinical Investigation Plan 
Zynex or the site may need to make protocol changes during the study. Such amendments will be documented and 
reviewed, and changes will be submitted to Zynex for first approval, then to the IRB for approval. Zynex and the 
site will decide whether or not to continue to enroll participants during this time. The site may proceed with the 
amendment upon receipt of IRB approval. 
 
Deviations from the Clinical Investigation Plan 
Investigators are not allowed to deviate from the Clinical Investigation Plan (CIP) except under emergency 
circumstances. Deviations from the CIP to protect the rights, safety, and wellbeing of human participants may 
proceed without prior approval of the Sponsor or the IRB. Such deviations shall be documented and reported to 
the Sponsor and the IRB as soon as possible but within 5 working days of the occurrence of such deviation. 
 
Deviations that significantly affect the safety, efficacy, integrity, or conduct of the study must be reported to the 
Sponsor within 5 working days from awareness of occurrence and reported to the IRB per the deviation reporting 
policy. 
 
Deviations that do not affect the safety, efficacy, integrity, or conduct of the study will be documented in the case 
report forms, regulatory binder Protocol Deviation Log as appropriate. 
  
Device Accountability 
A Device Accountability Log will be maintained for the Sponsor’s equipment, documenting date of receipt, 
description of device (including model number, lot number, serial number or unique code, and quantity) and date 
of return for used and unused product. Device usage will be recorded in the Case Report Form for each individual 
participant. 
 
Packaging and Labeling 
Research conducted for this study will utilize investigational devices and devices cleared through the 510k 
regulatory process. The Sponsor is responsible for packaging and labeling the device for delivery to the study site. 
FDA cleared devices do not require special labeling. Investigational devices or their immediate packages shall bear 
a label with the following information: name and place of the manufacturer, packager, or distributor, the quantity 
of contents, if appropriate, and the following statement:  

CLINIMARK Test Plan  
Clinical Evaluation of Zynex Monitoring System, Model CM-1600 
PR2022-516 
 
Clinimark 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Clinical Evaluation of the Zynex Monitoring System, Model CM-
1600 ID# PR 2022-516 
Principal Investigator: Arthur Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
PR# 2022-516 
SHEET   23   of   30 
REV 1 
 
Confidential & Proprietary to Clinimark, LLC. 
“CAUTION - Investigational device. Limited by Federal (or United States) law to investigational use.” 
 
The label or other labeling shall describe all relevant contraindications, hazards, adverse effects, interfering 
substances or devices, warnings, and precautions. 
 
It is the Investigator’s responsibility to ensure that the appropriate labeling is visible and remains intact throughout 
the life of the study. 
 
The Instructions for Use (IFUs) are provided as separate documents from this protocol. 
 
Storage and Accountability 
The site will store the investigational product. The storage area should be locked/secure with access limited only to 
approved study staff.  
 
The site will record and track usage of the investigational device by each participant. Documentation should verify 
that the device use was in accordance with the approved protocol. The Equipment Document in the Case Report 
Form shall provide documentation of the devices used on the study participant(s). 
 
Cleaning  
Please refer to CM-1600 Instructions for Use. 
 
 
Statement of Compliance 
The study will be conducted in accordance with the Declaration of Helsinki, 21 CFR 50, and 21 CFR 812 for non-
significant risk device study investigations. The study will not commence until the approval has been received from 
the IRB. 
 
Reference Documents 
• 
IRB Approved Informed Consent for Study Title: Clinical Evaluation of the Zynex Blood Volume 
Monitor (CM-1600) PR 2022-516 
• 
ISO 80601-2-61, first edition 2011-04-01, applicable sections, Clause 50 and Annex EE.3 Medical 
electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance 
of pulse oximeter equipment 
• 
FDA Guidance Document for Pulse Oximeters, March 4, 2013 
• 
World Medical Association Declaration of Helsinki, Ethical Principles for Medical Research Involving 
Human Participants 
• 
ISO 14155:2011 Clinical investigation of medical devices for human participants — Good clinical 
practice 
• 
Clinimark Adverse Events Reporting Document B3000-000-003 (current revision) 
• 
Cai Y, Holm S, Jenstrup M, Strømstad M, Eigtved A, Warberg J, Højgaard L, Friberg L, Secher NH. 
Electrical admittance for filling of the heart during lower body negative pressure in humans. J Appl 
Physiol. 2000 Oct;89(4):1569-76. 
• 
Cai Y, Zimmerman A, Ladefoged S, Secher NH. Can Haemodialysis-Induced Hypotension Be Predicted? 
Nephron 2002; 92(3):582-8. 
• 
Ishibe S, Peixoto AJ. Methods of assessment of volume status and intercompartmental fluid shifts in 
hemodialysis participants: implications in clinical practice. Semin Dial. 2004 Jan-Feb;17(1):37-43. 
• 
Krantz T, Cai, Y, Lauritsen T, Warberg J, Secher NH. Accurate monitoring of blood loss: thoracic electrical 
impedance during hemorrhage in the pig. Acta Anaesthesiol Scand. 2000; 44(5):598-604. 
• 
Matzen S, Perko G, Groth S, Friedman DB, Secher NH. Blood volume distribution during head-up tilt 
induced central hypovolaemia in man. Clin Physiol. 1991 Sep;11(5):411-22. 

CLINIMARK Test Plan  
Clinical Evaluation of Zynex Monitoring System, Model CM-1600 
PR2022-516 
 
Clinimark 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Clinical Evaluation of the Zynex Monitoring System, Model CM-
1600 ID# PR 2022-516 
Principal Investigator: Arthur Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
PR# 2022-516 
SHEET   24   of   30 
REV 1 
 
Confidential & Proprietary to Clinimark, LLC. 
• 
Perko MJ, Jarnvig IL, Højgaard-Rasmussen N, Eliasen K, Arendrup H. Electric Impedance for Evaluation 
of Body Fluid Balance in Cardiac Surgical Participants. Journal of Cardiothoracic and Vascular 
Anesthesia. 2001; 15(1):44-8. 
• 
Perko G, Payne G, Secher NH. An indifference point for electrical impedance in humans. Acta Physiol 
Scand. 1993 Jun;148(2):125-9. 
 
Informed Consent Process 
• 
The Principal Investigator or his / her designee conducts the informed consent process. 
• 
Verify that the participant acknowledges ability to read English. 
• 
Instruct the participant to ask questions at any time during this process, especially about things they do 
not understand. 
• 
Allow participant ample time to read the entire form and ask questions 
• 
Give a thorough description of the study and the participant’s involvement, with particular emphasis that 
they may withdraw from the study at any time. 
• 
After the participant has read the form, ask if he/she understands everything. 
• 
Ask if he/she would like to take part in the study, and if so, ask him/her to sign and date the form. 
• 
Once the participant has signed and dated the informed consent, the Principal Investigator or authorized 
designee will sign and date the form. 
• 
Give a copy of the informed consent to the participant. 
• 
No procedure may be performed before the informed consent is signed by the participant. 
 
If an Investigator uses a device without obtaining informed consent, the Investigator shall report such use to the 
Sponsor and the reviewing IRB within 5 working days after the use occurs.  
 
 
Safety 
Investigators 
All experimenters must review the protocol prior to test and sign that they read and understood the contents. 
 
Participant 
Equipment is checked out for proper functionality prior to being placed on the participant.  
   
The participant or legal guardian of the participant will review and sign the informed consent following a 
discussion of the test procedure; after all questions regarding the study have been answered; and prior to the 
start of any study procedures. The participant will complete the health assessment questionnaire and disclose 
any pertinent issues that may affect his/her health during the test. The participant or legal guardians of the 
participant may withdraw the participant from the study at any time. The participant may be withdrawn per 
the Procedure section below.   
 
A clinician will be present to monitor the participant at all times. Safety monitoring includes ECG, SpO2, pulse 
rate, respiration rate, direct observation and communication with the participant. 
 
Adverse Event Definitions 
The definitions for adverse event, adverse device effect, serious adverse event, serious adverse device effect, 
unanticipated adverse device effect, and their classifications are provided below (ISO 14155, 21 CFR 812.3). 
• 
Adverse Device Effect (ADE): Adverse event related to the use of an investigational medical device 
and resulting from insufficiencies or inadequacies in the instructions for use, the deployment, 
installation, the operation, any malfunction of the investigational medical device, or from usage error. 

CLINIMARK Test Plan  
Clinical Evaluation of Zynex Monitoring System, Model CM-1600 
PR2022-516 
 
Clinimark 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Clinical Evaluation of the Zynex Monitoring System, Model CM-
1600 ID# PR 2022-516 
Principal Investigator: Arthur Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
PR# 2022-516 
SHEET   25   of   30 
REV 1 
 
Confidential & Proprietary to Clinimark, LLC. 
• 
Adverse Event (AE): Any untoward medical occurrence, unintended disease or injury, or any 
untoward clinical signs (including an abnormal laboratory finding) in participants, users, or other 
persons, whether or not related to the investigational medical device or investigational procedure. 
• 
Anticipated Serious Adverse Device Effects (ASADE): ASADE is an effect which, by its nature, 
incidence, severity, or outcome has been identified in the risk analysis report. 
• 
Mild:  A mild adverse event is one in which the participant is aware of the event, but it is easily 
tolerated without intervention. 
• 
Moderate: A moderate adverse event is one that causes sufficient discomfort to interfere with usual 
activities. 
• 
Serious Adverse Device Effect (SADE): An adverse device effect results in any of the consequences 
characteristic of a serious adverse event. 
• 
Serious Adverse Event (SAE): A serious adverse event results in death, inpatient hospitalization, 
severe or permanent disability, a life-threatening illness or injury, fetal distress, fetal death, a 
congenital abnormality, a birth defect, or requires medical or surgical intervention to prevent 
permanent impairment to body or structure.  
• 
Severe: A severe adverse event results in the inability to perform usual activities. 
• 
Unanticipated Adverse Device Effect (UADE): A serious adverse device effect is one which, by its 
nature, incidence, severity, or outcome has not been identified in the current version of the risk 
analysis report. 
 
Management of Adverse Event Reporting 
Should the participant experience an adverse or non-typical event, the investigational staff will assess the situation 
and determine appropriate actions. The Medical Director and Principal Investigator will be contacted as 
appropriate. Adverse Events are reported through standard Clinimark procedures, IRB requirements, and per 
Zynex SOPs.   
 
Records of adverse events will be recorded in the Case Report Form. 
The following information will be obtained: 
• 
Type of effect (ADE, AE. ASADE, SADE, SAE, UADE) 
• 
Date of onset and resolution 
• 
Intensity (mild, moderate, severe) 
• 
Serious (yes/no) 
• 
Relationship to device (unknown, not related, possibly related, probably related, definitely related) 
• 
Anticipated (yes/no) 
• 
Treatment given and / or action taken (procedure stopped, withdrawn from study, no action) 
 
 
 

CLINIMARK Test Plan  
Clinical Evaluation of Zynex Monitoring System, Model CM-1600 
PR2022-516 
 
Clinimark 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Clinical Evaluation of the Zynex Monitoring System, Model CM-
1600 ID# PR 2022-516 
Principal Investigator: Arthur Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
PR# 2022-516 
SHEET   26   of   30 
REV 1 
 
Confidential & Proprietary to Clinimark, LLC. 
Reporting of Serious Adverse Events and / or UADE 
All SAE’s, SADE, ASADE, and UADE will be reported in writing to the Principal Investigator, Medical Director, 
Sponsor, and IRB as soon as possible and no later than 10 working days after the Investigator first learns of the 
event.  
 
If the event results in death of a participant, the event shall be reported to the Principal Investigator, Clinimark 
Medical Director, Sponsor, and IRB within 24 hours of knowledge of the event. 
 
For this study, AE contacts are: 
SAE Email: 
  
 
 
Kristin Andrud 
 kandrud@zynex.com 
Medical Monitor:  
 
 
Dr. Arthur Cabrera, MD 
 
Sponsor Representative:   
 
Kristin Andrud, Clinical Research Associate 
Clinimark Clinical Project Manager:  
Anne Fedor, RN 
Clinimark Study Coordinator: 
 
Anna Cobb, RN 
SAE Mailing Address: 
 
 
Zynex Monitoring Solutions 
 
 
 
 
 
c/o Kristin Andrud 
 
 
9555 Maroon Circle 
 
 
Englewood, CO 80112 
 
 
 
 
Sponsor Records and Reports 
 
Records 21 CFR 812.140 (b) 4,5 
The following records shall be consolidated in one location and available for FDA inspection and copying:  
• 
The name and intended use of the device and the objectives of the investigation 
• 
A brief explanation of why the device is not a significant risk device 
• 
The name and address of each Investigator 
• 
The name and address of each IRB that has reviewed the investigation 
• 
A statement of the extent to which the good manufacturing practice regulation in part 820 will be 
followed in manufacturing the device 
• 
Any other information required by FDA 
• 
Records concerning adverse device effects (whether anticipated or unanticipated) and complaints   
 
Reporting 21 CFR 812.150 (b) 1,2,3,5,6,7,8,9,10: 
The Sponsor shall prepare and submit the following complete, accurate, and timely reports: 
 
 
 
 
Unanticipated Adverse Device Effect 
The Sponsor shall immediately conduct an evaluation of an unanticipated adverse device effect. The results of 
such evaluation shall be reported to the FDA, IRB, and participating Investigators as soon as possible and not 
later than 10 working days after the Investigator first learns of the effect.  
 
Withdrawal of IRB approval 

CLINIMARK Test Plan  
Clinical Evaluation of Zynex Monitoring System, Model CM-1600 
PR2022-516 
 
Clinimark 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Clinical Evaluation of the Zynex Monitoring System, Model CM-
1600 ID# PR 2022-516 
Principal Investigator: Arthur Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
PR# 2022-516 
SHEET   27   of   30 
REV 1 
 
Confidential & Proprietary to Clinimark, LLC. 
Withdrawal of IRB approval shall be reported to the FDA, IRB, and the Investigator within 5 working days after 
receipt of withdrawal of approval by the Sponsor. 
 
Withdrawal of FDA approval 
Withdrawal of FDA approval of an investigation shall be reported by the Sponsor to the IRB and the 
Investigator within 5 working days after receipt of notice of withdrawal of approval. 
 
Progress Reports 
The Sponsor shall submit progress reports to the IRB at least yearly. 
 
Recall and device 
The Sponsor shall notify the FDA and all reviewing IRBs of any request that an Investigator return, repair, or 
otherwise dispose of any units of a device. Such notice shall occur within 30 working days after the request is 
made and shall state why the request was made. 
 
Final Report 
The Sponsor shall submit a final report to the IRB with 6 months after termination or completion of the 
investigation. 
 
Informed consent  
The Sponsor shall submit to the FDA a copy of any report by an Investigator under paragraph (a)(5) of this 
section of use of a device without obtaining informed consent, within 5 working days of receipt of notice of 
such use.  
 
Significant risk device determinations – (does not apply to NSR studies) 
If an IRB determines that a device is a significant risk device, and the Sponsor had proposed that the IRB 
consider the device not to be a significant risk device, the Sponsor shall submit to FDA a report of the IRB's 
determination within 5 working days after the Sponsor first learns of the IRB's determination.  
 
Other 
A Sponsor shall, upon request by a reviewing IRB or FDA, provide accurate, complete, and current information 
about any aspect of the investigation.  
 
Investigators Records and Reporting  
Records 21 CFR 812.140 (a)(3)(i) 
The Investigator maintains records of each participant’s case history and exposure to the device and 
supporting data, including signed and dated consent, health assessment form, and progress notes during the 
study. Records should show evidence that informed consent was signed and dated prior to the participant 
engaging in the study.  
 
Reports 21 CFR 812.150 (a) 1,2,5,7 
The Investigator shall prepare and submit the following complete, accurate, and timely reports:  
 
 
Unanticipated adverse device effects 
The Investigator shall submit to the Sponsor and to the reviewing IRB a report of any unanticipated adverse 
device effect occurring during an investigation as soon as possible, but in no event later than 10 working days 
after the Investigator first learns of the effect.  
 
Withdrawal of IRB approval 

CLINIMARK Test Plan  
Clinical Evaluation of Zynex Monitoring System, Model CM-1600 
PR2022-516 
 
Clinimark 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Clinical Evaluation of the Zynex Monitoring System, Model CM-
1600 ID# PR 2022-516 
Principal Investigator: Arthur Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
PR# 2022-516 
SHEET   28   of   30 
REV 1 
 
Confidential & Proprietary to Clinimark, LLC. 
The Investigator shall report to the Sponsor, within 5 working days, a withdrawal of approval by the reviewing 
IRB of the Investigator's part of an investigation.  
 
Informed consent 
If an Investigator uses a device without obtaining informed consent, the Investigator shall report such use to 
the Sponsor and the reviewing IRB within 5 working days after the use occurs.  
 
Other 
The Investigator shall, upon request by a reviewing IRB or FDA, provide accurate, complete, and current 
information about any aspect of the investigation.  
 
Withdrawal, Early Termination, or Suspension of the Investigation 
Participation in the study is voluntary. The participant may choose to withdraw from the study at any point. If a 
participant officially withdraws from the study, the laboratory staff will document the reason for withdrawal in the 
case report. 
  
Participation in the study may also be stopped at any time by the Principal Investigator or by the Sub-Investigators 
or Sponsor for the following reasons: 
• 
The participant’s failure to cooperate fully (as determined by the Investigator in his or her sole discretion) 
with the required conduct of this study 
• 
The participant’s development of an illness as determined by the Investigator in his or her sole discretion 
• 
A determination by a Clinimark representative (in his or her sole discretion), for whatever cause, that the 
study should be discontinued 
• 
A determination by the Sponsor (in his or her sole discretion), for whatever cause, that the study should 
be discontinued 
 
The collection of data for study participants will cease in the following cases:  
• 
Participant completes all study requirements 
• 
Participant withdraws consent 
• 
Investigator’s decision that it is in participant’s best interest to be discontinued from the study 
• 
Participant death  
• 
Adverse event other than death requiring withdrawal of the participant from the study 
• 
Determination that the participant was ineligible for the study 
 
No follow-up procedures for withdrawn or discontinued participants are required, unless such is required at the 
Investigator’s discretion. 
 
Consideration for early termination or suspension of the investigation may be related to unanticipated equipment 
failure or a decision by the Sponsor or the site. Both Zynex and Clinimark reserve the right to discontinue the study 
at any time for administrative or other reasons. Written notice of study termination will be submitted to the 
Investigator in advance of such termination. Termination of a specific site may occur because of, but not limited to, 
inadequate data collection, low participant enrollment, or non-compliance with the protocol or other research 
requirements. 
 
Early termination results when the study is closed prior to the end of the study. A study suspension is a temporary 
postponement of the study activities related to enrollment. Both are possible for the study. If the study is 
terminated or suspended, no additional enrollment will be allowed unless otherwise informed by the Sponsor. The 
current participants will be followed according to the protocol. 
 
If the study is terminated prematurely or suspended by the Sponsor/Investigator, the Sponsor /Investigator will 
promptly inform the regulatory authorities (if required) of the termination and the reason(s). IRB/IECs will also be 

CLINIMARK Test Plan  
Clinical Evaluation of Zynex Monitoring System, Model CM-1600 
PR2022-516 
 
Clinimark 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Clinical Evaluation of the Zynex Monitoring System, Model CM-
1600 ID# PR 2022-516 
Principal Investigator: Arthur Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
PR# 2022-516 
SHEET   29   of   30 
REV 1 
 
Confidential & Proprietary to Clinimark, LLC. 
promptly informed and provided with the reason(s) for termination or suspension by the Sponsor/ Investigator. 
The Investigator will promptly inform the participants and ensure appropriate follow-up for the participant. 
 
If the Investigator (or IRB/IEC) terminates or suspends the investigation, the Investigator will promptly inform the 
institution (if required) and the IRB/IEC, and will provide a detailed written explanation of the termination or 
suspension. The Investigator will promptly inform the participants and ensure appropriate therapy and follow-up 
for the participants. The Sponsor will inform the regulatory authorities (if required). 
 
Withdrawal of IRB approval shall be reported to the Sponsor by the Investigator within 5 working days. 
 
In case of early termination of the study, all study participants should be followed until the resolution of any 
pending adverse event(s). 
 
Publication Policy 
All information concerning the CM-1600, such as patent applications, formulas, manufacturing processes, scientific 
data, specific study designs, protocols, and formulation information supplied by the Sponsor and not previously 
published is considered confidential and will remain the sole property of the Sponsor. The Investigator agrees to 
use this information only in accomplishing the purposes of this study and will not use it for other purposes without 
the Sponsor’s written consent. 
 
It is understood by the Investigator that the information developed in the clinical study will be used by the Sponsor 
in connection with the development of the CM-1600 and, therefore, may be disclosed as required to the FDA or to 
other government regulatory agencies. To use the information derived from the clinical studies, it is understood 
that said user is obligated to provide the Sponsor with complete test results and all data developed in the study. 
 
The Investigator will not publish any information pertaining to the device, equipment, procedures, or results 
specified in the Protocol without the Sponsor’s prior written consent, and such consent will not be unreasonably 
withheld. 
 
 
 

CLINIMARK Test Plan  
Clinical Evaluation of Zynex Monitoring System, Model CM-1600 
PR2022-516 
 
Clinimark 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Clinical Evaluation of the Zynex Monitoring System, Model CM-
1600 ID# PR 2022-516 
Principal Investigator: Arthur Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
PR# 2022-516 
SHEET   30   of   30 
REV 1 
 
Confidential & Proprietary to Clinimark, LLC. 
 
Attachment A - Protocol Signature Page 
Protocol No. PR 2022-516 
As the Principal Investigator, I confirm that I have read this protocol, I understand it, and I will work according to 
this protocol and to the ethical principles stated in accordance with the Declaration of Helsinki, 21 CFR 50, and 21 
CFR 812: or the applicable laws and regulations of the country of the study site for which I am responsible, 
whichever provides the greater protection of the individual: 
 
• 
Ensuring that each participant’s informed consent is obtained prior to the start of any study procedure 
• 
Ensuring that the investigation is conducted according to the Clinical Investigation Plan 
• 
Personally conducting or supervising the investigation 
• 
Protecting the rights, safety, and welfare of participants 
• 
Preparing and maintaining adequate, current, and complete case histories or records 
• 
Retaining records for two years following the date the marketing application is approved or withdrawn 
• 
Furnishing the required reports to the Sponsor, including reports of adverse events and study completion 
• 
Providing timely reports to the IRB, including reports of changes in the research activity needed to avoid 
immediate hazards to participants, unanticipated problems involving risks to participants or others, 
including adverse events to the extent required by the IRB 
• 
Ensuring that changes are not implemented without prospective IRB approval, unless required to 
eliminate immediate hazard to participants 
• 
Complying with all FDA test article requirements 
• 
Adequately maintaining control of test articles, including appropriate tracking documentation for test 
articles to the extent that such control and documentation are not centrally administered 
• 
Supervising the use and disposition of the test article 
• 
Disclosing relevant financial information 
• 
Ensuring that all associates, colleagues, and employees assisting in the conduct of the investigation(s) are 
informed about their obligations in meeting the above commitments 
• 
An Investigator shall, upon request by a reviewing IRB or FDA, provide accurate, complete, and current 
information about any aspect of the investigation. 
 
 
 
 
Signature of Investigator  
Date 
Arthur Cabrera, MD 
 
 
Investigator Name (print or type) 
 
 
Principal Investigator 
 
 
Investigator Title 
 
 
Clinimark Laboratory 
 
 
Name of Facility 
 
 
Louisville, CO USA 
 
 
Location of Facility (City, State, Country)