A Clinical Study to Evaluate the Safety and Accuracy of the Saranas Early Bird Bleed Monitoring System for the Detection of Endovascular Procedure Related Bleeding Events
Phase: NA
Conditions: Endovascular Procedures
Sponsor: Saranas, Inc.

CLINICAL PROTOCOL 
A CLINICAL STUDY TO EVALUATE THE SAFETY AND ACCURACY OF THE 
SARANAS EARLY BIRD™ BLEED MONITORING SYSTEM FOR THE DETECTION 
OF ENDOVASCULAR PROCEDURE RELATED BLEEDING EVENTS 
Protocol Number: 
 
PVP004 
Original Protocol Issue Date: 
May 4, 2018 
Sponsor: 
Saranas, Inc. 
2450 Holcombe Blvd 
Houston TX 77021 
Tel: (713) 357-1049 
CONFIDENTIALITY STATEMENT 
This document contains trade secrets and commercial information that are privileged or 
confidential and may not be disclosed unless such disclosure is required by federal or state law or 
regulations.  In any event, persons to whom the information is disclosed must be informed that the 
information is privileged or confidential and may not be further disclosed by them.   These 
restrictions on disclosure will apply equally to all future information supplied to you which is 
indicated as privileged or confidential. 

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STUDY SYNOPSIS 
Title 
A Clinical Study to Evaluate the Safety and Accuracy of the 
Saranas Early Bird Bleed Monitoring System for the Detection of 
Endovascular Procedure Related Bleeding Events 
Protocol Number 
PVP004 
Investigational Product 
Saranas Early Bird Bleed Monitoring System (EBBMS) 
Subject Population 
Patients undergoing a large-bore (≥10F) endovascular procedure 
via femoral access 
Study Objectives 
To evaluate the safety and accuracy of the Saranas EBBMS for 
the detection of access site related internal bleeding events during 
large-bore endovascular procedures 
Primary Endpoint 
Level of agreement in bleeding detection between the Saranas 
EBBMS and post-procedural computerized tomography  
Secondary Endpoints 
• Level of agreement in bleeding detection between the Saranas
EBBMS 
and 
clinical 
assessment 
or 
post-procedural
computerized tomography
• Device sensitivity in bleeding detection of the Saranas EBBMS
as compared to post-procedural computerized tomography
• Device specificity in bleeding detection of the Saranas EBBMS
as compared to post-procedural computerized tomography
• Device sensitivity in bleeding detection between Saranas
EBBMS 
and 
clinical 
assessment 
or 
post-procedural
computerized tomography
• Device specificity in bleeding detection between Saranas
EBBMS 
and 
clinical 
assessment 
or 
post-procedural
computerized tomography
• Relationship between level (severity) of bleed detected by the
Saranas EBBMS and the severity of bleeding as assessed by
computerized tomography
• Relationship between level (severity) of bleed detected by the
Saranas EBBMS and the severity of bleeding as assessed by the
absolute drop in hemoglobin
• Relationship between level (severity) of bleed detected by the
Saranas EBBMS and the number of transfusions
• Relationship between level (severity) of bleed detected by the
Saranas EBBMS and the severity of bleeding as assessed by

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Protocol Number:  PVP004 
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VARC-2 criteria 
• Relationship between level (severity) of bleed detected by the
Saranas EBBMS and the occurrence of post-procedural acute
kidney injury
Safety Endpoints 
From enrollment until end of study, all: 
•
Device and procedure-related adverse events
•
Serious adverse events
•
Serious adverse device effects
Study Design 
This is a multi-center, open-label study to evaluate use of the 
Saranas EBBMS for detection of access site-related internal 
bleeding events during large-bore endovascular procedures. 
After signing consent, subjects will undergo screening procedures 
and be scheduled for their endovascular procedure.  The 
endovascular procedure will be performed per the institution’s 
standard practices, with inclusion of monitoring using the Saranas 
EBBMS.  Following completion of the procedure, subjects will 
continue to be monitored using the Saranas EBBMS for internal 
bleeds for up to 8 hours.  The Saranas EBBMS will then be 
removed.  Adverse events and device effects will be recorded 
from enrollment of subjects and throughout the procedure, until 
discharge of subjects. 
Study Procedures 
After signing Informed Consent, subjects will undergo screening 
procedures including assessment of eligibility, demographics, 
medical history, concomitant medications, physical examination, 
indication for intervention, and laboratory assessments. 
Following confirmation of eligibility and enrollment, subjects will 
optimally undergo a CT scan (with or without contrast; not 
mandatory) prior to the endovascular procedure to assess for the 
presence of prior recent bleeding events or vascular complications. 
They will then undergo their planned endovascular procedure with 
monitoring for internal bleeding using the Saranas EBBMS. 
Following completion of the endovascular procedure, subjects will 
undergo non-contrast CT to detect or confirm internal bleeding, if 
medically possible.  Subjects will continue Saranas EBBMS 
monitoring for up to 8 hours after completion of the endovascular 
procedure.  
Number of Patients: 
100 
Number of Sites 
5-10 sites in the US 

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Study Duration 
The study is anticipated to be approximately 5 months in duration. 
The duration of each subject’s participation will be approximately 
1 day. 
Inclusion Criteria 
•
≥18 years of age
•
Willing and capable to sign an Informed Consent form
•
Planned large-bore endovascular procedure via the common
femoral artery using a large bore catheter (≥10 Fr) such as
trans-femoral transcatheter aortic valve replacement (TAVR),
balloon aortic valvuloplasty, complex or high-risk
percutaneous coronary intervention requiring hemodynamic
support device (Impella 2.5, Impella CP, and ECMO), or
endovascular aortic repair (EVAR).
Exclusion Criteria 
•
Subject is participating, or planning to participate in a clinical
trial or study of an investigational product that may influence
the data collected for this investigation
•
Inability to access common femoral artery or vein with large
bore catheters
•
Unstable conditions such as cardiogenic shock, or ST-
elevated MI
•
Current active bleeding
•
Pre-procedural conditions precluding the realization of a post-
procedural CT scan
•
Pregnancy
•
Mental disability or any other lack of fitness, in the
Investigator's opinion, to preclude subject's participation in or
ability to complete the study as planned.
Statistical Methods 
Descriptive statistics to be reported for each analyzed variable will 
include the number of observations, mean, median, standard 
deviation and range for quantitative variables, frequency and 
relative percent for ordinal and categorical variables. Level of 
agreement will be assessed using Cohen Kappa statistic for 
categorical variable, intraclass correlation for multiples categories, 
and Pearson correlation for continuous variables. Summary 
statistics will be displayed in tabular and/or graphical format. 
Missing data will not be interpolated for any analyses. Any 
hypothesis tests will be performed using a two-sided significance 
level of 0.05. 

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Table 1. 
Schedule of Events 
Procedure/ Assessment 
Screening 
-14 to 0 days
Day of Procedure 
Prior to large 
bore sheath 
Insertion 
During 
procedure 
Post-
procedure 
At discharge 
Informed consent 
X 
Eligibility 
X 
Demographics 
X 
Medical history/indication 
X 
Concomitant medications 
X 
Physical exam 
X 
Serum 
CBC/Creatinine/PT-
PTT/INR 
X 
X1 
X2 
X 
Activated clotting time 
X 
X2 
Large bore endovascular 
access plan 
X 
Contrast CT scan 
X3 
Non-contrast CT scan 
X3 
X 
Saranas EBBMS insertion 
X 
Saranas EBBMS 
monitoring 
X4 
X4 
Saranas EBBMS removal 
X 
Adverse events 
X 
X 
X 
1.
Just after Saranas EBBMS insertion and before its activation
2.
Immediately before Saranas EBBMS removal
3.
If available per standard of care.  May be performed up to 90 days prior to the procedure.
4.
For up to 8 hours following procedure

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TABLE OF CONTENTS 
STUDY SYNOPSIS ..........................................................................................................2 
PROTOCOL APPROVALS .............................................................................................6 
TABLE OF CONTENTS ..................................................................................................7 
LIST OF TABLES ..........................................................................................................9 
LIST OF FIGURES ..........................................................................................................9 
SARANAS, INC. REPRESENTATIVES ......................................................................10 
LIST OF ABBREVIATIONS .........................................................................................11 
1.0 
INTRODUCTION................................................................................................12 
1.1 
Background ..............................................................................................12 
1.2 
Report of Prior Investigations ................................................................13 
1.2.1 Animal Investigations ....................................................................13 
1.2.2 Human Investigations ....................................................................17 
2.0 
STUDY DEVICE .................................................................................................18 
2.1 
Intended Use .............................................................................................18 
2.2 
Device Description ...................................................................................18 
2.3 
Instructions for Use..................................................................................18 
2.4 
How Supplied ...........................................................................................19 
2.5 
Labeling ....................................................................................................19 
2.6 
Device Storage ..........................................................................................20 
3.0 
DESIGN OF THE STUDY ..................................................................................21 
3.1 
Objectives..................................................................................................21 
3.2 
Endpoints ..................................................................................................21 
3.2.1 Primary Endpoint ...........................................................................21 
3.2.2 Safety Endpoints ............................................................................22 
3.3 
Patient Eligibility .....................................................................................22 
3.3.1 Inclusion Criteria ...........................................................................22 
3.3.2 Exclusion Criteria ..........................................................................22 
3.4 
Subject Withdrawal Criteria ..................................................................22 
3.5 
Study Design .............................................................................................22 
3.6 
Study Procedures and Assessments ........................................................24 
3.6.1 Laboratory Assessments ................................................................24 
3.6.2 Subject Monitoring and Care .........................................................24 
3.6.3 Endovascular Access Procedure ....................................................24 
3.6.4 Vital Signs ......................................................................................24 
3.6.5 CT Scans ........................................................................................24 
3.6.6 Bleeding, Vascular Complications, and Acute Kidney Injury 
Assessment .....................................................................................24 
4.0 
STUDY CONDUCT .............................................................................................27 
4.1 
Screening ...................................................................................................27 
4.2 
Patient Enrollment ...................................................................................27 
4.3 
Endovascular Procedure .........................................................................27 
4.3.1 Pre-Endovascular Procedures ........................................................27 
4.3.2 Endovascular Procedure.................................................................27 

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4.3.3 Post-Endovascular Procedure ........................................................28 
5.0 
ADVERSE DEVICE EFFECTS .........................................................................29 
5.1 
Recording and Reporting Adverse Events ............................................29 
5.1.1 Recording Adverse Events .............................................................29 
5.1.2 Laboratory Abnormalities ..............................................................30 
5.1.3 Grading Severity of Adverse Events..............................................30 
5.1.4 Assigning Relationship of Adverse Events to Study Product ........30 
5.2 
Serious Adverse Events ...........................................................................31 
5.2.1 Definition of a Serious Adverse Event ..........................................31 
5.2.2 Reporting SAEs .............................................................................31 
5.3 
Unanticipated Adverse Device Effects ...................................................31 
5.4 
Device Complications...............................................................................32 
5.5 
Risk/Benefit Analysis ...............................................................................32 
5.5.1 Potential Risks and Discomforts .................................................32 
5.5.2 Methods to Minimize Risks ...........................................................32 
5.5.3 Potential Benefits ...........................................................................33 
6.0 
STATISTICAL CONSIDERATIONS ...............................................................34 
6.1 
Patient Sample Size Requirements .........................................................34 
6.2 
Primary Efficacy Endpoint .....................................................................34 
6.3 
Secondary Endpoints ...............................................................................34 
6.4 
Safety Endpoints ......................................................................................35 
6.5 
Study Populations ....................................................................................35 
6.6 
Statistical Analytical Plan .......................................................................35 
6.6.1 Demographics and Subject Characteristics ....................................35 
6.6.2 Assessment of Endpoints ...............................................................35 
6.6.3 Assessment of Safety .....................................................................38 
6.6.4 General Statistical Issues ...............................................................38 
7.0 
REGULATORY AND ADMINISTRATIVE REQUIREMENTS ..................39 
7.1 
Accountability of Investigational Product .............................................39 
7.2 
IRB Requirements ...................................................................................39 
7.3 
Protocol Amendments .............................................................................39 
7.4 
Informed Consent ....................................................................................40 
7.5 
Confidentiality ..........................................................................................40 
7.6 
Required Regulatory Documents ...........................................................41 
7.7 
Record Retention .....................................................................................41 
7.8 
On-Site Audits ..........................................................................................42 
7.9 
Case Report Form Completion ...............................................................42 
7.10 
Study Completion/Termination ..............................................................42 
7.11 
Monitoring Procedures ............................................................................42 
7.12 
Use of Information and Publication Policy ............................................43 
7.13 
Ethical and Legal Considerations...........................................................43 
8.0 
REFERENCES .....................................................................................................44 
APPENDIX A: 
INVESTIGATOR AGREEMENT .............................................46 
APPENDIX B. 
INSTRUCTIONS FOR USE .......................................................48 

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LIST OF TABLES 
Table 1. 
Schedule of Events .................................................................................................. 5 
Table 2. 
Sensitivity and Specificity at Level 1 Detection ................................................... 16 
Table 3. 
Paired Differences Between Bleed Indication Levels .......................................... 17 
Table 4. 
VARC-2 Definitions Bleeding Severity ............................................................... 25 
Table 5. 
VARC-2 Definitions Vascular Complications...................................................... 25 
Table 6. 
Acute Kidney Injury (AKIN Classification) ......................................................... 26 
LIST OF FIGURES 
Figure 1 
Saranas Early Bird Bleed Monitoring System ...................................................... 13 
Figure 2 
Animal Study Flow Chart ..................................................................................... 15 
Figure 3. 
Bleed Detection Volumes ..................................................................................... 17 
Figure 4. 
Saranas Early Bird Bleed Monitoring System Label ............................................ 19 
Figure 5. 
User Interface Display Label ................................................................................ 20 
Figure 6. 
Study Flowchart .................................................................................................... 23 

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SARANAS, INC. REPRESENTATIVES 
The Clinical Trial is sponsored by Saranas, Inc.  Overall responsibility for the trial will be held 
by: 
Zaffer Syed, CEO 
Saranas, Inc. 
2450 Holcombe Blvd. 
Suite X 
Houston, TX  77021 
Office telephone: 
(713) 357-1049  
Responsibility for coordination of the clinical trial will be held by: 
Jennifer L. Wike, Senior Director of Project Management and Regulatory Affairs 
Proxima Clinical Research, Inc. 
2450 Holcombe Blvd. 
Houston, TX  77021 
Office telephone 
(281) 356-2759 
Cell:   
 
(832) 457-9561 
Email address: Jenny@ProximaCRO.com 
Questions regarding clinical and scientific conduction of the study should be addressed to the 
Principal Investigator: 
Philippe Genereux, M.D. 
Saranas, Inc 
Office telephone: 
(862) 309-3583 
Email address: philippe.genereux@atlantichealth.org 
Medical issues should be addressed to the Safety Officer: 
Joachim F. Wernicke, Ph.D., M.D. 
Office telephone: (317) 815-0120 
Email address: Joe@ProximaCRO.com 
Clinical monitoring of the study will be performed by representatives from the following 
organization: 
Proxima Clinical Research, Inc. 
2450 Holcombe Blvd., Suite J 
Houston, TX 77021 
Office telephone: 
(346) 772-0300, Ext 2363 
Office fax: 
 
(713) 842-6135 
Contact person: 
Jennifer L. Wike, Sr. Director of Project Management and 
Regulatory Affairs 

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LIST OF ABBREVIATIONS 
ADE  
Adverse device effect 
AE 
 
Adverse event 
ALT 
 
Alanine aminotransferase 
AST 
 
Aspartate aminotransferase 
CBC  
Complete blood count 
CFA  
Common femoral artery 
CRA  
Clinical Research Associate 
CRF 
 
Case Report Form 
CT 
 
Computed Tomography 
DC 
 
Device complication 
EBBMS 
Early Bird Bleed Monitoring System 
ECMO  
Extra corporeal membrane oxygenation 
EVAR  
Endovascular aortic repair 
FDA  
Food and Drug Administration 
GCP  
Good Clinical Practices 
GRACE 
Global Registry of Acute Coronary Events 
IBC 
 
Internal bleeding complications 
IDE 
 
investigational device exemption 
IFU 
 
Instructions for use 
INR 
 
International Normalized Ratio 
IRB 
 
Institutional Review Board 
ITT 
 
Intent-to-treat 
MI 
 
Myocardial infarct 
NHLBI 
National Heart and Lung Association 
PCBA  
Printed circuit board assembly 
PP 
 
Per protocol 
PT 
 
Prothrombin time 
PTT 
 
Partial thromboplastin time 
SAE 
 
Serious adverse event 
SGOT   
Serum Glutamic Oxaloacetic Transaminase 
SGPT  
Serum glutamic pyruvic transaminase 
TAVR  
Trans-femoral aortic valve replacement 
TIMI  
Thrombolysis in myocardial infarction 
UADE  
Unanticipated adverse device effect 
UID 
 
User interface display 
VARC  
Valve Academic Research Consortium  

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1.0 
INTRODUCTION 
1.1 
Background 
Vascular access is necessary for any medical procedure that requires stable communication 
with a blood vessel. In 2010, more than 17 million procedures requiring vascular access were 
performed in the United States1,2. One percent of these procedures were associated with a 
bleeding complication at the access site severe enough to warrant blood transfusion. These 
complications are difficult to detect; in most cases, extensive bleeding has occurred by the 
time signs or symptoms become evident. 
Vascular access is most commonly achieved by using a hollow-bore needle to puncture the 
vessel, then introducing a hollow sheath into the vessel via the Seldinger technique3. The 
sheath provides the operator with a stable means of introducing and removing devices such as 
balloons and stents (in cardiac, vascular, or interventional radiology procedures), infusing 
medications (in chronic chemotherapy or antibiotic therapy), filtering blood (in hemodialysis), 
or removing blood for analysis (in the assessment of hospitalized patients, especially those 
who are critically ill).  
The single most frequent complication associated with any procedure involving vascular 
access is an internal bleeding complication (IBC) at the site where the needle initially enters 
the blood vessel4,5. Often, during initial vessel puncture, the physician may accidentally 
penetrate the wall of the vessel, initiating an IBC. Bleeding is further aggravated by the fact 
that patients undergoing these procedures are often receiving high-dose of anticoagulant 
therapy. 
In a recent review, Vavalle and Rao summarized key studies and registry data involving IBC’s 
in patients undergoing percutaneous coronary interventions and showed that any degree of 
procedural bleeding is associated with significantly increased risk of ischemic injury and 
mortality6. In a three-hospital registry (n=10,974) described by Kinnaird et al, 5.4% of the 
patients had major bleeding (Thrombolysis in Myocardial Infarction [TIMI] classification) 
and received transfusions. In the National Heart Lung and Blood Association (NHLBI) 
registry (n=6,656), 1.8% of the patients had access site hematomas that necessitated 
transfusion7. In the Global Registry of Acute Coronary Events (GRACE) (n=24,045), there 
was a 3.9% incidence of major bleeding; almost a fourth of these hemorrhages (23.8%) 
occurred at the vascular access site8,9.  
Many IBC’s are noted only after sheath removal. However, their trigger is thought to occur at 
the time of needle puncture, and small leaks are believed to occur before and during sheath 
placement. Early awareness of internal bleeding will allow physicians to directly and 
immediately address this complication and increase post-procedural vigilance in these 
vascular interventions10,11.  
In most cases, extensive bleeding has invariably occurred when signs or symptoms become 
evident12,13. This often necessitates surgical intervention and/or blood transfusions to manage 
these complications. Bleeding at the vascular access site is associated with increased 
mortality, length of hospitalization and cost8,14,15. 
Presently, no marketed technology exists that can alert clinicians to an ongoing IBC 
immediately at its onset during a vascular access procedure. Although existing imaging 

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modalities such as ultrasound and computed tomography (CT) scans can identify these 
bleeding complications, it would be impractical and expensive to prophylactically incorporate 
their use as part of the clinical workflow for every procedure involving vascular access. To 
address this unmet need, Saranas has developed the Early Bird Bleed Monitoring System, 
hereinafter referred to as Saranas EBBMS (Figure 1), to detect an IBC in real-time without 
interrupting normal procedures. This technology may enable physicians to mitigate 
downstream consequences by addressing these complications immediately, thereby lowering 
long-term risks to the patient and the associated healthcare expenditures. 
Figure 1 Saranas Early Bird Bleed Monitoring System 
 
 
1.2 
Report of Prior Investigations 
1.2.1 Animal Investigations 
In addition to the prospective, self-controlled acute animal investigation described below, at least 
three earlier prototype iterations of the Saranas EBBMS (>30 devices) were tested in swine and 
ovine animal models.  The results from earlier studies provided evidence that a functionalized 
vascular access sheath using bioimpedance spectroscopy can detect an intraprocedural vascular 
access IBC through measuring significant changes in normalized bioimpedance response curves.  
These results concluded that the Early Bird device design was final and ready for validation.  
Also, completion of these earlier studies enabled refinement of the validation protocol and study 
design.  
Prospective Animal Investigation Summary 
A prospective, self-controlled acute animal investigation was conducted to evaluate the safety 
and efficacy of the Saranas EBBMS in detecting extravascular fluid accumulation via simulated 
IBC.  The primary endpoint was sensitivity of level 1 bleed detection, and the secondary 

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endpoint was bleed progression performance.  Additional endpoints were histology, local tissue 
and systemic response, overall animal health and device handling characteristics. 
Test Animals 
Test animals were 20 female Yorkshire Cross swine > 70kg.  Swine were selected as the 
vasculature is similar to humans with respect to blood pressure and blood flow in the femoral 
arteries and veins, and clinical bleeding simulations can be reasonably well carried out with 
injection volumes that are deemed critical in human interventions. 
Procedure 
Two legs were used on each animal, with the sequence of testing of the left and right legs and 
use of an artery or vein being randomized.  The study flow chart is shown in Figure 2. 

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Figure 2 Animal Study Flow Chart 
20 Animals
(2 devices/animal)
EarlyBird Insertion
And PowerUp
Randomization: 20 
Arterial + 20 Venous; 
20 Left Leg + 20 
Right Leg
Non-Bleed
Period
(10 minutes)
IBC is 
Indicated
Yes
No
Superficial Hematoma
Simulation 
Gross Necropsy
Vessel Harvest/
Histopathology
40 samples total
End of Study
 
 
After anesthesia and preparation of the insertion site, the Saranas EBBMS was introduced into 
the artery or vein, and a clinical intervention was simulated (non-bleed phase).   For the bleed 
simulation phase, blood solution injection was initiated with a peristaltic pump to infuse 500 mL 
of blood solution at a rate of 10mL/min, into the treatment site with clinical interventions 
simulated.  Once Saranas EBBMS blood level indicators (1, 2 and 3) were triggered, infused 
volumes and fluoroscopic images were collected.  Animals were then euthanized. 
Each animal was observed during the test period, and any abnormal findings were recorded 
including local, systemic and behavioral abnormalities and their potential influence on the results 

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obtained in the study outcomes. All observed instances of animal illness and death were recorded 
during the study. 
Results and Conclusions 
The outcome of the study resulted in 100% sensitivity and 100% specificity in 40 bioimpedance 
datasets which included 10 detections of true positive bleeding events (i.e. access site bleeds that 
occur during the Non-Bleed Phase). 
Table 2. Sensitivity and Specificity at Level 1 Detection 
Early Bird Level 1 
Bleed Detection 
Bleed Status 
Bleed Simulations or 
Access Site Bleeds 
No Bleed Simulations or    
No Access Site Bleeds 
Detection 
40 = True Positive* 
0 = False Positive 
Non-Detection 
0 = False Negative 
30 = True Negative 
Sensitivity/Specificity 
Sensitivity = 100% 
Specificity = 100% 
* 10 bleeds that occurred during the Non-Bleed Phase and 30 bleeds that were detected 
during the Bleed Simulation Phase (40 total) 
Histopathology analysis determined that there was no specific damage to the vessel walls that 
was associated with the Saranas EEBMS use.  Any endothelial loss was attributed to a common 
outcome of using intravascular devices, and the pathologist noted that the endothelium will 
reendothelialize within a few weeks with no further damage.  All animals survived to the 
conclusion of their acute implant procedures with no major adverse events noted. 
From the 30 simulated IBCs, bioimpedance data were analyzed for volumetric distribution 
relative to the triggered bleed indicator levels (Levels 1, 2, and 3).  Both central tendency 
statistics (mean, median) and variability statistics (standard deviation, range) increased as the 
bleed indicator levels increased.  There was definitive separation between the distributions at the 
three bleed indicator levels. 

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Figure 3. Bleed Detection Volumes 
 
Box and Whisker Plot Depicting Bleed Detection Volumes (mL) at each Bleed Detection 
Level. The bottom of each box represents the lower quartile (Q1, the 25th percentile); the top of 
each box represents the upper quartile (Q3, 75 percentile), the thick line in each box represents 
the median (M, the 50th percentile); the "whiskers" represent the farthest points that are not 
outliers, i.e., that are within 1.5 times the interquartile range of Q1 and Q3.  The blue dot 
represents the mean bleed detection volume. 
 
Table 3. Paired Differences Between Bleed Indication Levels  
Descriptive Statistics 
Level 2 vs. 
Level 1 
Level 3 vs. 
Level 2 
Level 3 vs. 
Level 1 
Mean (SD) 
46.3 (46.5) 
67.7 (77.2) 
114.0 (96.1) 
Range 
12.0 – 262.0 
15.0 – 412.0 
38.0 – 461.0 
Median 
33.5 
44.0 
81.0 
Wilcoxon Signed Rank 
Test (P-Value) 
<0.001 
<0.001 
<0.001 
1.2.2 Human Investigations 
To date there have been no investigations in humans. 

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2.0 
STUDY DEVICE 
2.1 
Intended Use 
The Saranas EBBMS is intended:  
• to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices 
while minimizing blood loss associated with such insertions.  
• to provide physicians with an early indication of extravascular fluid accumulation, which 
may be due to a potential internal bleeding complication.  
• to detect and monitor changes in bioimpedance due to extravascular fluid accumulation, and 
to provide physicians with indications that a potential internal bleeding complication is 
progressing. 
2.2 
Device Description 
The Saranas EBBMS is a standard introducer sheath with a real-time IBC detection system and 
is designed to integrate smoothly into normal vascular access procedures and/or surgical 
protocols by continuously sensing and measuring potential changes in regional bioimpedance, 
which indicate a potential IBC. Referring to Figure 1, the system consists of the following: a 
vascular access sheath with 4 embedded electrodes, positioned along the length of the cannula, 
that form a bioimpedance measurement circuit; a User Interface Display (UID) which houses a 
printed circuit board assembly (PCBA) running an algorithm that analyzes bioimpedance and can 
trigger visible and audible indicators to communicate the state of change in bioimpedance, as 
depicted by the larger blood drop symbols, to the attending physician.  
After Saranas EBBMS insertion, baseline bioimpedance readings are collected. As the procedure 
progresses, the bioimpedance changes in response to an IBC, which is detected by the device. 
The UID features a three-level bleed indicator system that sequentially illuminates LED 
indicators to show an increase in IBC progression at the following levels: 
• Level 1 indicator (1st LED) is triggered by the early onset of a bleed.  An audible alert is 
momentarily activated once this level is triggered. 
• Level 2 indicator (2nd LED) is triggered as the bleed progresses when a bioimpedance 
threshold is reached.  An audible alert, longer in duration than the 1st LED, is 
momentarily activated once this level is triggered.   
• Level 3 indicator (3rd LED) is triggered as the bleed continues to progress further when a 
higher bioimpedance threshold is reached.  An audible alert is activated once this level is 
triggered and requires the attending physician to silence the device by pressing the 
silence button. 
2.3 
Instructions for Use 
The Instructions for Use are provided in Appendix B. 

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2.4 
How Supplied 
The Saranas EBBMS is supplied sterile and non-pyrogenic, packaged for single use.  The 
package includes a dilator. 
2.5 
Labeling 
The labelling of the product is shown in Figure 1 below. 
Figure 4. Saranas Early Bird Bleed Monitoring System Label 
 
 

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Figure 5. User Interface Display Label 
 
 
The label shown in Figure 5 will also have a (handwritten) 3-digit number to identify each 
individual device. 
2.6 
Device Storage 
Store in a cool, dry place. 
 

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3.0 
DESIGN OF THE STUDY 
3.1 
Objectives 
The objectives of this study are to assess the preliminary safety and efficacy of the Saranas 
EBBMS for the detection of access site related internal bleeding events during endovascular 
procedures. 
In addition, device usability, access site bleed rates and vascular complication rates will be 
assessed. 
3.2 
Endpoints 
3.2.1 Primary Endpoint 
The primary endpoint is the level of agreement in bleeding detection between the Saranas 
EBBMS and post-procedural computerized tomography. 
3.2.2 Secondary Endpoints 
The following secondary endpoints will be assessed: 
• Level of agreement in bleeding detection between the Saranas EBBMS and clinical 
assessment or post-procedural computerized tomography.  
• Device sensitivity in bleeding detection of the Saranas EBBMS as compared to post-
procedural computerized tomography. 
• Device specificity in bleeding detection of the Saranas EBBMS as compared to post-
procedural computerized tomography. 
• Device sensitivity in bleeding detection between Saranas EBBMS and clinical assessment 
or post-procedural computerized tomography. 
• Device specificity in bleeding detection between Saranas EBBMS and clinical assessment 
or post-procedural computerized tomography. 
• Relationship between level (severity) of bleed detected by the Saranas EBBMS and the 
severity of bleeding as assessed by computerized tomography. 
• Relationship between level (severity) of bleed detected by the Saranas EBBMS and the 
severity of bleeding as assessed by the absolute drop in hemoglobin. 
• Relationship between level (severity) of bleed detected by the Saranas EBBMS and the 
number of transfusions. 
• Relationship between level (severity) of bleed detected by the Saranas EBBMS and the 
severity of bleeding as assessed by VARC-2 criteria. 
• Relationship between level (severity) of bleed detected by the Saranas EBBMS and the 
occurrence of post-procedural acute kidney injury. 

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3.2.2 Safety Endpoints 
From enrollment until end of study, all: 
• Device and procedure-related adverse events 
• Serious adverse events 
• Serious adverse device effects 
3.3 
Patient Eligibility 
3.3.1 Inclusion Criteria 
Patients must meet the following inclusion criteria to be eligible for the study: 
• ≥18 years of age 
• Willing and capable to sign an Informed Consent form 
• Planned large-bore endovascular procedure via the common femoral artery using a large bore 
catheter (≥10 Fr) such as trans-femoral transcatheter aortic valve replacement (TAVR), 
balloon aortic valvuloplasty, complex or high-risk percutaneous coronary intervention 
requiring hemodynamic support device (Impella 2.5, Impella CP, and ECMO), and 
endovascular aortic repair (EVAR). 
3.3.2 Exclusion Criteria 
Patients meeting any of the following criteria will be excluded from the study: 
• Subject is participating, or planning to participate in a clinical trial or study of an 
investigational product that may influence the data collected for this investigation 
• Inability to access common femoral artery or vein with large bore catheters 
• Unstable conditions such as cardiogenic shock, or ST-elevated MI 
• Current active bleeding  
• Pre-procedural conditions precluding the realization of a post-procedural CT scan 
• Pregnancy 
• Mental disability or any other lack of fitness, in the Investigator's opinion, to preclude 
subject's participation in or ability to complete the study as planned. 
3.4 
Subject Withdrawal Criteria 
There are no foreseeable situations where subject withdrawal should be required.  Withdrawal of 
a subject from the study will be at the Investigator’s discretion with consideration of the safety 
and well-being of the subject. 
3.5 
Study Design 
This is a multi-center, open-label study to evaluate use of the Saranas EBBMS for detection of 
access site-related internal bleeding events during large-bore endovascular procedures. 

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After signing consent subjects will undergo screening procedures and be scheduled for their 
endovascular procedure.  The endovascular procedure will be performed per the institution’s 
standard practices, with inclusion of monitoring using the Saranas EBBMS.  Following 
completion of the procedure subjects will continue to be monitored using the Saranas EBBMS 
for internal bleeds for up to 8 hours.  The EBBMS will then be removed.  A flowchart is 
provided in Figure 6.  Adverse events and device effects will be recorded from enrollment of 
subjects and throughout the procedure, until discharge of subjects.  
Figure 6. Study Flowchart 
 
Planned endovascular procedure involving 
large-bore catheter 
Informed Consent 
Eligibility/Screening procedures 
Enroll subject and assign number 
Pre-procedure CT  
(contrast or non-contrast CT; optional) 
Endovascular Procedure 
Introduce and activate Saranas EBBMS first 
Perform endovascular procedure 
Post-procedure monitoring with Saranas 
EBBMS for up to 8 hours 
Prior to EBBMS removal:  
CT scan non-contrast and blood sample 
Remove Saranas EBBMS 
Clinical follow-up, pre-discharge blood 
sample, discharge  

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3.6 
Study Procedures and Assessments 
The following procedures and assessments will be performed during the study.  For the Schedule 
of Events see Table 1. 
3.6.1 Laboratory Assessments 
• Blood Chemistry: creatinine,  
• Hematology:  CBC, PT, PTT, INR 
3.6.2 Subject Monitoring and Care 
The institutions standard of care monitoring procedures and post-procedural care practices will 
be followed. 
3.6.3 Endovascular Access Procedure 
The type of endovascular procedure and the indication for treatment will be recorded. The 
procedure will be performed according to the institution’s standard practices.   
3.6.4 Vital Signs 
Blood pressure, heart rate, respiration, temperature. 
3.6.5 CT Scans 
CT scans (with or without contrast) will be optimally (not mandatory) performed prior to the 
endovascular access procedure to assess for the presence of prior recent bleeding events or 
vascular complications (i.e. pseudonaeurysm, fistula).  Following the procedure, a CT scan 
(without contrast, unless otherwise indicated) will be performed to confirm or identify any 
bleeding events. Reference the Imaging Acquisition Protocol in the Study Procedures Manual. 
3.6.6 Bleeding, Vascular Complications, and Acute Kidney Injury Assessment 
The VARC-2 definitions will be used for bleeding severity and vascular complications, refer to 
Table 4 and Table 5.  For classification of acute kidney injury refer to the AKIN Classification in 
Table 6. 
 

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Table 4. VARC-2 Definitions Bleeding Severity 
Life-threatening or disabling bleeding  
• Fatal bleeding OR 
• Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial 
necessitating pericardiocentesis, or intramuscular with compartment syndrome OR 
• Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or 
surgery OR 
• Overt source of bleeding with drop in hemoglobin >5 g/dL or whole blood or packed 
red blood cells (RBCs) transfusion >4 units)* 
Major bleeding  
• Overt bleeding either associated with a drop in the hemoglobin level of at least 3.0 g/dl 
or requiring transfusion of two or three units of whole blood/RBC, or causing 
hospitalization or permanent injury, or requiring surgery AND 
• Does not meet criteria of life-threatening or disabling bleeding 
Minor bleeding  
• Any bleeding worthy of clinical mention (e.g. access site hematoma) that does not 
qualify as life-threatening, disabling, or major 
*Given that one unit of packed RBC typically will raise the hemoglobin concentration by 1 
g/dl, an estimated decrease in hemoglobin will be calculated. 
 
Table 5. VARC-2 Definitions Vascular Complications 
Major Vascular Complications 
1. Any aortic dissection, rupture, left ventricular perforation, or new apical 
aneurysm/pseudoaneurysm 
2. Access site or access-site related vascular injury (dissection, perforation, stenosis, hematoma, 
etc.) leading to death, life-threatening or major bleeding, visceral ischemia, or neurological 
impairment 
3. Distal embolization requiring vascular surgery, amputation, or irreversible end organ damage 
4. Unplanned endovascular or surgical intervention associated with death, major bleeding, 
visceral ischemia, or neurological impairment 
5. Any new ipsilateral lower extremity ischemia 
6. Surgery for access site-related nerve injury 
7. Permanent access site-related nerve injury 

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Minor Vascular Complications 
1. Access site or access-site related vascular injury (dissection, perforation, stenosis, hematoma, 
etc.) NOT leading to death, life-threatening or major bleeding, visceral ischemia, or 
neurological impairment 
2. Distal embolization treated with embolectomy and/or thrombectomy and NOT resulting in 
amputation or end organ damage 
3. Unplanned endovascular stenting or unplanned surgical intervention not meeting the criteria 
for a major vascular complication 
4. Vascular repair or the need for vascular repair (via surgery, ultrasound-guided compression, 
transcatheter embolization, or stent-graft 
5. Percutaneous closure device failure 
6. Failure of a closure device to achieve hemostasis at the arteriotomy site leading to alternative 
treatment (other than manual compression or adjunctive endovascular ballooning) 
 
Table 6. Acute Kidney Injury (AKIN Classification) 
Stage 1 
• Increase in serum creatinine to 150–199% (1.5–1.99 x increase compared with baseline) 
OR increase of >0.3 mg/dl (>26.4 mmol/l) 
Stage 2 
• Increase in serum creatinine to 200–299% (2.0–2.99 × increase compared with baseline) 
Stage 3 
• Increase in serum creatinine to >300% (>3 × increase compared with baseline) OR serum 
creatinine of >4.0 mg/dl (>354 mmol/l) with an acute increase of at least 0.5 mg/dl 
(44 mmol/l). 
The increase in creatinine must occur within 48 h. †Patients receiving renal replacement therapy 
are considered to meet Stage 3 criteria irrespective of other criteria. 

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4.0 
STUDY CONDUCT 
For the Schedule of Events refer to Table 1. 
4.1 
Screening 
Within 14 days prior to the procedure, the following baseline/screening assessments will be 
performed: 
• Informed consent 
• Assessment of eligibility 
• Demographics  
• Medical history 
• Indication for endovascular procedure 
• Physical exam 
• Vital signs 
• Hematology (refer to Section 3.6.1) 
• Blood chemistry (refer to Section 3.6.1) 
4.2 
Patient Enrollment 
After signing Informed Consent, and after study eligibility has been confirmed, patients will be 
enrolled in the study. A Subject Number will be assigned.   
4.3 
Endovascular Procedure 
4.3.1 Pre-Endovascular Procedures 
The following assessments and procedures will be performed prior to the endovascular 
procedure: 
• The endovascular procedure will be planned. 
• CT scans (with or without contrast) will be optimally (not mandatory) performed prior to 
the endovascular access procedure to assess for the presence of prior recent bleeding 
events or vascular complications (i.e. pseudonaeurysm, fistula).  CT scan may be 
performed up to 90 days prior to the procedure. 
• Assessment of baseline signs and symptoms 
4.3.2 Endovascular Procedure 
The endovascular procedure will be performed in accordance with the institution’s standard 
practices.  The appropriate Saranas EBBMS sheath size will be selected, at the Investigator’s 
discretion, and introduced per the Instructions for Use (refer to Appendix B).  The data to be 
collected are as follows: 
• Type of endovascular procedure 

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• Type of vessel cannulated with Saranas EBBMS (e.g. femoral artery, femoral vein) 
• Access technique (e.g. ultrasound-guided, micro-puncture, anterior vs. posterior 
puncture) 
• Large bore sheath size  
• Type of large bore sheath 
• Investigator’s actions in response to any bleed detection, e.g. anti-thrombotic reversal, 
termination of the procedure, additional imaging or interventions. 
• Recording of adverse events and/or device complications. 
The Saranas EBBMS should be inserted in the femoral vein first. Blood sample (CBC, PT, PTT, 
INR, and creatinine) should be collected from the Saranas EBBMS after its insertion and prior to 
its activation. Afterwards, ipsilateral large bore access could be achieved.  
 
During the endovascular procedure, the following assessments should be collected: 
• Activated clotting time 
4.3.3 Post-Endovascular Procedure 
After completion of the endovascular procedure the following assessments and procedures will 
be performed: 
• Saranas EBBMS monitoring for up to 8 hours post-procedure 
• A non-contrast CT scan (or contrast CT if clinically indicated or preferred) to identify or 
confirm any bleeds  
• CBC, PT, PTT, INR, creatinine and activated clotting time should be collected 
immediately before removal of the Saranas EBBMS 
• Removal of Saranas EBBMS 
• Recording of adverse events and/or device complications 
• Recording of the number of units of blood transfused 
• Prior to discharge, serum CBC, PT, PTT, INR and creatinine   
• Subject will be discharged 
• Return of device to sponsor for assessment of impedance response. 
 

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5.0 
ADVERSE DEVICE EFFECTS 
An Adverse Device Effect (ADE) is an adverse event related to the use of a medical device. This 
includes: 
• Any adverse event resulting from insufficiencies or inadequacies in the Instructions for Use, 
the deployment, the implantation, the installation, the operation, or any malfunction of the 
medical device 
• Any event that is a result of a use error or intentional misuse. 
Adverse Device Effects will be recorded as Adverse Events (AEs) and/or Device Complications 
(DCs). 
5.1 
Recording and Reporting Adverse Events 
An Adverse Event (AE) is defined as any untoward medical occurrence in a subject of a clinical 
investigation associated with use of an investigational product and that does not necessarily have 
a causal relationship with this product.  An AE can therefore be any unfavorable and unintended 
sign (including an abnormal laboratory finding), symptom, or disease temporally associated with 
the use of an investigational product, whether or not related to use of the product. 
5.1.1 Recording Adverse Events 
Adverse events with an onset date following enrollment of the subject until the subject completes 
the study (is discharged) will be collected.  Each adverse event will be followed until the adverse 
event has resolved or stabilized.  Subjects should be encouraged to report adverse events 
spontaneously or in response to general, non-directed questioning.  For each AE volunteered by 
the subject, the Investigator should obtain all the information required to complete the Adverse 
Event page of the CRF: 
• Standard medical terminology for the AE  
• Date and time of onset 
• Severity of the event  
• Relationship between the adverse event and the investigational product or related 
procedure 
• Description of any subject therapy administered and actions required 
• Outcome of the AE 
• Whether or not the effect was serious and/or unanticipated 
All AEs, regardless of seriousness, severity, or presumed relationship to study intervention must 
be recorded using medical terminology in the source document and on the adverse experience 
case report form.   
Whenever possible, a diagnosis should be given when signs and symptoms are due to common 
etiology (e.g., cough, runny nose, sneezing, sore throat, and head congestion should be reported 
as "upper respiratory infection").   

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Each adverse event should be reported separately.  For example, “nausea and vomiting” should 
be split into two separate events. 
All AEs must be followed until resolution or until a stable clinical endpoint is reached.  All 
measures required for AE management and the ultimate outcome of the AE must be recorded in 
the source document and reported to the Sponsor.  
5.1.2 Laboratory Abnormalities 
An abnormal laboratory result not explained by a recorded clinical diagnosis or condition will be 
considered an adverse event if it is: 
• Grade 3 or 4, 
• Clinically significant (requires further diagnostic testing or treatment), or  
• Considered to be an Adverse Event by the Investigator. 
5.1.3 Grading Severity of Adverse Events 
The severity of AEs will be graded as follows:  
Mild 
Awareness of a sign or symptom that does not interfere with the 
patient’s usual activity or is transient, resolved without treatment and 
with no sequelae. 
Moderate 
Interferes with the patient’s usual activity and/or requires symptomatic 
treatment. 
Severe 
Symptom(s) causing severe discomfort and significant impact of the 
patient’s usual activity and requires treatment. 
5.1.4 Assigning Relationship of Adverse Events to Study Product 
A relationship must be assigned by the Investigator to each reported adverse event, and will be 
documented as follows: 
Not related 
The cause of the AE is known and the event is not related to any 
aspect of study participation. 
Unlikely to be 
related 
There is little or no temporal relationship to the study device and/or a 
more likely alternative etiology exists. 
Possibly related 
There is a reasonable possibility that the event may have been caused 
by study participation. 
The AE has a timely relationship to the study procedure(s); however, 
follows no known pattern of response, and an alternative cause 
seems more likely or there is significant uncertainty about the cause of 
the event.  
Probably related It is likely that the event was caused by study participation. 
The AE has a timely relationship to the study procedure(s) and 
follows a known pattern of response; a potential alternative cause, 
however, may explain the event. 

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Related 
A related event has a strong temporal relationship and an 
alternative cause is unlikely. 
5.2 
Serious Adverse Events 
5.2.1 Definition of a Serious Adverse Event 
A Serious Adverse Event (SAE) is defined as any event meeting any of the following criteria: 
•
Is life-threatening (immediate risk of death) or fatal
•
Requires, or significantly prolongs, inpatient hospitalization
•
Results in persistent or significant disability and/or incapacity
•
Is a congenital anomaly or birth defect
•
Requires medical or surgical intervention to prevent one of the outcomes listed above
5.2.2 Reporting SAEs 
Serious Adverse Events (SAE) will be reported to the Sponsor’s Safety Officer within 24 hours 
of the Investigator becoming aware of the event, and a written report provided within 3 business 
days to: 
Joachim F. Wernicke, Ph.D., M.D. 
Tel: (317) 815-0120  
Cell: (317) 440-2353 
A Serious Adverse Event report will be prepared and will contain as much available information 
concerning the event as possible so that a written reported may be filed with the FDA. 
In accordance with Federal regulations, Investigators will be notified of the occurrence of serious 
and unexpected adverse events.  The Investigator must promptly inform the relevant Institution 
Review Board in accordance with the IRB’s policies. 
Documentation of submission of SAEs to the IRB must be forwarded to Proxima and the 
Sponsor and retained in the Investigator’s Study File. 
5.3 
Unanticipated Adverse Device Effects 
Any SAE that has been determined to be device or procedure-related should be further classified 
as anticipated or unanticipated.  An unanticipated adverse device effect (UADE) is any serious 
adverse effect on health or safety, any life-threatening problem or death caused by, or associated 
with a device, if that effect, problem, or death was not previously identified in nature, severity, or 
degree of incidence in the application; or any other unanticipated serious problem associated 
with a device that relates to the rights, safety, or welfare of subjects. 
Investigators must report any (potential) unanticipated adverse device effects to the sponsor and 
their IRB as soon as possible but no later than within 10 working days after the investigator first 
learns of the event [21 CFR 812.150]. UADEs should be reported immediately via telephone or 
email to the Sponsor Safety Officer as well as on the eCRF.  

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5.4 
Device Complications 
Investigators are instructed to report all possible device deficiencies, malfunctions, misuse or use 
error observed during the course of the trial. These incidents will be documented in the case 
report form provided as follows: 
Device deficiency: Inadequacy of a medical device related to its identity, quality, durability, 
reliability, safety or performance.  Device deficiencies include malfunction, use error, and 
inadequate labeling. They may or may not affect device performance or lead to an adverse event. 
Device malfunction: Failure of an investigational medical device to perform in accordance with 
its intended purpose when used in accordance with the Instructions for Use (IFU) or protocol.  
device malfunction occurs when the device is used in compliance with the IFU but does not 
perform as described in the IFU. 
Use error: Act or omission of an act that results in a different medical device response than 
intended by the manufacturer or expected by the user.  Use error includes slips, lapses and 
mistakes. An unexpected physiological response of the patient does not itself constitute a use 
error. 
Device misuse: Any use of the investigational device by an investigator that is contradictory to 
the application described in the Instructions for Use will be categorized as device misuse. This is 
a form of Use Error. 
5.5 
Risk/Benefit Analysis 
5.5.1 Potential Risks and Discomforts 
Enrollment in the trial involves exposure to some risks. Most risks of trial participation are not 
materially different than those encountered by an individual undergoing a large bore 
endovascular procedure outside the context of the trial as introducer sheaths are normally used to 
access the targeted vessels with the Early Bird.  However, the use of the Early Bird device may 
involve exposure to additional risks as well as other potential risks of an unknown nature.  
•
Blood loss, bleeding or hematoma
•
Embolization (micro or macro) with transient or permanent ischemia
•
Infection or scarring
•
Vascular trauma (dissection, rupture, perforation, tear etc.)
•
There is a risk that the procedure may not detect an internal bleed.
•
There is a risk of improper use of the device due to inadequate specifications or
training.
5.5.2 Methods to Minimize Risks 
•
Before releasing the patient, confirmation of internal bleeding status with non-contrast CT
scan.
•
Adequate IFU to ensure proper technique.

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• Only doctors who have been trained in the use of the Early Bird device will participate in 
the study 
• Only doctors with the necessary experience in large bore endovascular procedures will 
participate in this study  
5.5.3 Potential Benefits 
• Early detection of internal bleeds during the endovascular procedure 
• Less or no need for blood transfusions 
• Reduction in, or no drop in post-procedural hemoglobin levels. 
 

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6.0 
STATISTICAL CONSIDERATIONS 
6.1 
Patient Sample Size Requirements 
This study is intended to describe the accuracy and safety of the Saranas EBBMS.  A sample of 
approximately 100 subjects should provide adequate evaluation of the planned endpoints.  If 5%, 
n = 5, of subjects experience a bleed as detected by either the Saranas EBBMS or computerized 
tomography then the Kappa score remains above 0.7 when there are two or fewer discordant 
pairs.  The 95% confidence interval with two discordant pairs and Kappa of 0.74 ranges from 
0.39 to 1.0.   
6.2 
Primary Efficacy Endpoint 
The primary endpoint is the level of agreement in bleeding detection between the Saranas 
EBBMS and post-procedural computerized tomography. 
6.3 
Secondary Endpoints 
The following secondary endpoints will be assessed: 
• Level of agreement in bleeding detection between the Saranas EBBMS and clinical 
assessment or post-procedural computerized tomography  
• Device sensitivity in bleeding detection of the Saranas EBBMS as compared to post-
procedural computerized tomography 
• Device specificity in bleeding detection of the Saranas EBBMS as compared to post-
procedural computerized tomography 
• Device sensitivity in bleeding detection between Saranas EBBMS and clinical assessment or 
post-procedural computerized tomography 
• Device specificity in bleeding detection between Saranas EBBMS and clinical assessment or 
post-procedural computerized tomography 
• Relationship between level (severity) of bleed detected by the Saranas EBBMS and the 
severity of bleeding as assessed by computerized tomography 
• Relationship between level (severity) of bleed detected by the Saranas EBBMS and the 
severity of bleeding as assessed by the absolute drop in hemoglobin 
• Relationship between level (severity) of bleed detected by the Saranas EBBMS and the 
number of transfusions 
• Relationship between level (severity) of bleed detected by the Saranas EBBMS and the 
severity of bleeding as assessed by VARC-2 criteria. 
• Relationship between level (severity) of bleed detected by the Saranas EBBMS and the 
occurrence of post-procedural acute kidney injury 

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6.4 
Safety Endpoints 
From enrollment until end of study, all: 
• Device and procedure-related adverse events 
• Serious adverse events 
• Serious adverse device effects 
6.5 
Study Populations 
Intent to Treat Population:  The Intent to Treat (ITT) population is defined as all subjects who 
were enrolled in the study. 
Per Protocol Population:  The Per Protocol (PP) population is defined as all subjects who had a 
post-procedure computerized tomography.   
Safety Population:  The Safety Population is defined as all subjects who are enrolled, who 
receive study intervention, and who have some post-baseline assessment of safety data. 
6.6 
Statistical Analytical Plan 
6.6.1 Demographics and Subject Characteristics 
For all subjects included in this study, baseline demographic and medical history data will be 
summarized for each treatment group.  Summaries for quantitative variables include the sample 
size, mean, median, standard deviation, minimum, and maximum.  Summaries for categorical 
variables include the number and percent of patients for each outcome.  No statistical testing will 
be performed to compare these factors.  These summaries will be conducted in the all three 
populations, ITT, PP and Safety. 
6.6.2 Assessment of Endpoints 
Primary Endpoint 
The primary endpoint is the level of agreement in bleeding detection between the Saranas 
EBBMS and post-procedural computerized tomography.  Each case will be defined 
dichotomously as bleed or no bleed by both techniques.  This analysis will be conducted in the 
PP population of subjects who has a post-procedure computerized tomography. 
Level of agreement will be assessed using Cohen Kappa statistic.  A 95% confidence interval 
will be applied.  A good Kappa score is considered to be at 0.6 or greater.  for dichotomous 
endpoints.  Each case will be defined as a bleed or no bleeding.  

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Table 7.  Interpretation of Kappa Values 
kappa 
Level of Agreement 
0 
Equal to chance 
0<k≤0.20 
Poor 
0.21<k≤0.40 
Fair 
0.41<k≤0.60 
Moderate 
0.61<k≤0.80 
Good 
0.81<k≤0.99 
Excellent 
1 
Perfect 
 
 
Secondary Endpoints 
Device specificity and sensitivity will be defined as follows: 
Sensitivity will be assessed as: 
Sensitivity =  
                 Number of subjects with Confirmed Bleeds______________ 
 
 
Number of subjects with Confirmed Bleeds + number of False Negatives 
A Confirmed Bleed is a bleed detected by the Saranas EBBMS that is also confirmed by CT 
scan and/or clinical assessment. 
A False Negative is a bleed that is not detected by the Saranas EBBMS that is detected by 
CT scan and/or clinical assessment. 
Device specificity, assessed as: 
Specificity =                Number of subjects Confirmed with No Bleeds_______________ 
 
 
   Number of subjects Confirmed with No Bleeds + number of False Positives 
Confirmed with no bleeds is no bleed detected by the Saranas EBBMS that is confirmed by 
CT scan and/or clinical assessment. 
A False Positive is a bleed detected by the Saranas EBBMS that is not confirmed by CT scan 
and/or clinical assessment. 
 
The following secondary endpoints will be investigated: 

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Protocol Number:  PVP004 
Original Protocol Issue Date:  May 4, 2018 
• Level of agreement in bleeding detection between the Saranas EBBMS and clinical 
assessment or post-procedural computerized tomography will be calculated in a manner 
similar to specified for the primary endpoint.  This analysis will be conducted in both the PP 
and ITT population with the clinical determination of a bleed overruling any computerized 
tomography or missing assessment. 
• Device sensitivity in bleeding detection of the Saranas EBBMS as compared to post-
procedural computerized tomography will be calculated in the PP population. 
• Device specificity in bleeding detection of the Saranas EBBMS as compared to post-
procedural computerized tomography will be calculated in the PP population. 
• Device sensitivity in bleeding detection between Saranas EBBMS and clinical assessment or 
post-procedural computerized tomography will be calculated.  This analysis will be 
conducted in both the PP and ITT population with the clinical determination of bleed 
overruling any computerized tomography or missing assessment. 
• Device specificity in bleeding detection between Saranas EBBMS and clinical assessment or 
post-procedural computerized tomography will be calculated. This analysis will be conducted 
in both the PP and ITT population with the clinical determination of bleed overruling any 
computerized tomography or missing assessment. 
• Relationship between level (severity) of bleed detected by the Saranas EBBMS and the 
severity of bleeding as assessed by computerized tomography will be investigated.  Summary 
statistics and interclass correlations will be calculated to assess the relationship between the 
two variables.   
• Relationship between level (severity) of bleed detected by the Saranas EBBMS and the 
severity of bleeding as assessed by the absolute drop in hemoglobin from baseline will be 
investigated.  Summary statistics and interclass correlations will be calculated to assess the 
relationship between the two variables.   
• Relationship between level (severity) of bleed detected by the Saranas EBBMS and the 
number of transfusions will be investigated.  Tabulations, summary statistics and interclass 
correlations will be used to describe the relationship between these two variables.  
• Relationship between level (severity) of bleed detected by the Saranas EBBMS and the 
severity of bleeding as assessed by VARC-2 criteria will be investigated.  Tabulations, 
summary statistics and interclass correlations will be used to describe the relationship 
between these two variables.  
• Relationship between level (severity) of bleed detected by the Saranas EBBMS and the 
occurrence of post-procedural acute kidney injury will be investigated.  Summary statistics 
and interclass correlations will be calculated to assess the relationship between the two 
variables. 

CONFIDENTIAL AND PRIVATE INFORMATION OF SARANAS, INC. 
Page 38 of 63 
Protocol Number:  PVP004 
Original Protocol Issue Date:  May 4, 2018 
6.6.3 Assessment of Safety 
Safety will be assessed from device and procedure-related adverse events, serious adverse events 
and serious adverse device effects. 
Safety and tolerability will be assessed by evaluating reported AEs as well as any changes in 
values from baseline of clinical laboratory assessments.   
The incidence of treatment-emergent AEs will be reported overall and by severity and 
relatedness to study intervention.  AEs causing study discontinuation and serious adverse events 
will be listed and tabulated. 
6.6.4 General Statistical Issues 
Descriptive statistics to be reported for each analyzed variable will include the number of 
observations, mean, median, standard deviation and range for quantitative variables, frequency 
and relative percent for ordinal and categorical variables. 
Summary statistics will be displayed in tabular and/or graphical format. Missing data will not be 
interpolated, other than when a clinical assessment can replace a missing computerized 
tomography assessment. Any hypothesis tests will be performed using a two-sided significance 
level of 0.05. All computations will be performed using SAS®, version 9.1 or higher. 
 
 

CONFIDENTIAL AND PRIVATE INFORMATION OF SARANAS, INC. 
Page 39 of 63 
Protocol Number:  PVP004 
Original Protocol Issue Date:  May 4, 2018 
7.0 
REGULATORY AND ADMINISTRATIVE REQUIREMENTS 
7.1 
Accountability of Investigational Product 
The Investigator is required to maintain adequate records of the disposition of the investigational 
product, including dates, quantity, and use by subjects throughout the study.  Records will be 
kept on product accountability and inventory forms.  If the investigation is terminated, 
suspended, discontinued, or completed, or upon instruction from the Sponsor. the Investigator 
shall return the unused supplies to the Sponsor, in the original containers, to: 
C.G. Laboratories, Inc. 
1410 Southtown Drive 
Granbury, TX 76048 
The Investigator will not supply investigational study product to other investigators, nor allow 
use of investigational study product other than to patients registered on, and as directed by, this 
protocol.  The Investigator will dispense investigational product only from the designated 
investigational site. 
Accountability of study product will be verified by the Sponsor’s Study Monitor during on-site 
monitoring visits.  
7.2 
IRB Requirements 
United States Federal regulations require that all investigational product studies be conducted 
under the auspices of an Institutional Review Board (IRB), as defined in the Code of Federal 
Regulations, Title 21, Part 56.  This committee, the makeup of which must conform to the 
Federal, State and local guidelines regarding such, will approve all aspects of the Study, 
including said Protocol and Informed Consents to be used, prior to initiation.  The formal written 
approval notice must be signed by the chairman or authorized designee and must identify the 
specific protocol.  In cases where an IRB member has a conflicting interest, abstention of that 
individual from voting should be documented.  The investigator will provide the Sponsor with a 
copy of the communication from the Committee to Investigator indicating approval of the 
protocol and consent form.  All changes to the protocol and consent form must be reviewed and 
approved prior to implementation, except where necessary to eliminate apparent immediate 
hazards to human subjects. 
The Investigator must also report to the IRB, at least annually, on the progress of the 
investigation.  Continuing IRB review should be documented by a letter from the IRB.  
Notification to the IRB by the Investigator within three months after completion, termination, or 
discontinuation of the study at the specific site must be documented. 
7.3 
Protocol Amendments 
Amendments will originate from the Sponsor and will be provided to the Investigator for 
submission to his/her IRB for their review and approval prior to implementation.  It should be 
noted that when an amendment to a protocol substantially alters the study design or increases 
potential risk to the study patient, the informed consent should be revised and if applicable, 
patient’s consent to continue participation should again be obtained. 
No deviations from the protocol should be made except in emergency situations where 

CONFIDENTIAL AND PRIVATE INFORMATION OF SARANAS, INC. 
Page 40 of 63 
Protocol Number:  PVP004 
Original Protocol Issue Date:  May 4, 2018 
alternative treatment is necessary for the protection, proper care and wellbeing of patients.  In 
situations requiring a departure from the protocol, the Investigator or other physician in 
attendance will contact the Sponsor’s Clinical Representative by fax or telephone.  If possible, 
this contact will be made before implementing any departure from the protocol.  In all cases, 
contact with the Sponsor’s Clinical Representative must be made as soon as possible in order to 
discuss the situation and agree on an appropriate course of action.  The case report form and 
source document will describe any departure from the protocol and the circumstances requiring 
it. 
7.4 
Informed Consent 
The Investigator will be responsible for obtaining from every patient prior to his/her participation 
in the Study an Informed Consent signed by the patient or legally authorized representative, in 
accordance with the code of Federal Regulations, Title 21, Part 50.20.  The consent form that is 
used must be the current version and must be approved by both the reviewing IRB and by the 
Sponsor.  Informed consent will be obtained from the patient after a full explanation of the 
purpose of the study, risks and discomforts involved, potential benefits, etc. have been provided 
by the Investigator both verbally and in writing.  The original signed copy of the informed 
consent must be maintained in the institution’s records, and is subject to inspection by a Sponsor 
representative. 
7.5 
Confidentiality 
The sponsor is concerned for the individual patient’s privacy; therefore, all collected patient data 
will be treated confidentially, identified only by a patient identification number and patient 
initials.   
In compliance with federal guidelines regarding the monitoring of clinical studies and in 
fulfillment of the Investigator’s obligation to the Sponsor, it is required that he/she permit the 
Sponsor Study Monitor or Food and Drug Administration (FDA) representative to review that 
portion of the patient’s medical record that is directly related to the study.  This shall include all 
study relevant documentation (including medical histories to verify eligibility, laboratory tests 
results to verify transcription accuracy, treatment and diagnostic reports, admission/discharge 
summaries for hospital admissions occurring while the patient is on study, and autopsy reports 
for deaths occurring during or in temporal proximity to the study). 
As part of the required content of informed consent, the patient must be informed that his/her 
records will be reviewed by the Sponsor, the Study Monitor or a representative of the Food and 
Drug Administration.  Should access to the medical record require a separate waiver or 
authorization, it is the Investigator’s responsibility to obtain such permission from the patient in 
writing before the patient is entered into the study. 
All information provided to the Investigator by the Sponsor, including nonclinical data, 
protocols, CRFs, and verbal and written information, will be kept strictly confidential and 
confined to the clinical personnel involved in conducting this study, and no disclosure shall be 
made except in accordance with any right of publication granted to the Investigator.  

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Page 41 of 63 
Protocol Number:  PVP004 
Original Protocol Issue Date:  May 4, 2018 
7.6 
Required Regulatory Documents 
It is the responsibility of the Investigator and study staff to maintain a comprehensive and 
centralized filing system of all study-related documentation, which is suitable for inspection at 
any time by the Study Monitor and the FDA.  Elements should include: 
• Patient files containing the completed Case Report Forms, supporting source documentation 
and the Informed Consent. 
• Pharmacy or Investigator files, containing the Investigational Product Accountability 
Records or dispensation logs and all study product related correspondence.  
• Study files, containing the following required documentation: 
o Protocol with all amendments 
o Copies of all pre-study documentation and all correspondence to and from the IRB and 
the Sponsor or Sponsor representatives 
o An up-to-date curriculum vitae for the Principal Investigator. 
o Signed and dated Investigator Agreement. 
o Assurance that the reviewing IRB complies with the requirements set forth in Title 21 
Part 56 of the Code of U.S. Federal Regulations.  The required documentation will 
consist of the name and address of the IRB/EC and a list of its members, including their 
titles, occupations, and any institutional affiliations, or a Department of Health and 
Human Services Assurance number.  
o A copy of the formal written notification to the Investigator regarding approval of the 
protocol by the IRB. 
o A copy of the IRB approved informed consent form and other adjunctive materials (e.g., 
advertising) to be used in the study, including written documentation of IRB approval of 
these items. 
o A copy of the reference ranges for clinical laboratory evaluations and a copy of the 
certification of the laboratory facility. 
• In addition to the documents required prior to the study, other documentation may be 
required during the course of the study. 
7.7 
Record Retention 
The FDA requires that an Investigator retain study records for a period of two (2) years 
following the date that a marketing application is approved for the indication in which the study 
product is being investigated; or if no application or license is to be filed or if the application or 
license is not approved for such an indication, until two (2) years after the FDA is notified that 
the indication is discontinued. 
Study records include: all case report forms and all source documents (e.g., informed consent 
forms, laboratory reports, progress notes, medical histories, physical and diagnostic findings, 
diagnoses and dates of therapy prior to and during this study, device dispensing/disposition 
records) that support data entered on case report forms. 
If the Investigator for any reason desires to dispose of the records, they may be transferred to 
another institution, another investigator, or to the Sponsor upon written agreement between the 
Investigator and the Sponsor. 

CONFIDENTIAL AND PRIVATE INFORMATION OF SARANAS, INC. 
Page 42 of 63 
Protocol Number:  PVP004 
Original Protocol Issue Date:  May 4, 2018 
7.8 
On-Site Audits 
The FDA, in the person of a trained and properly authorized employee of the department, may 
request access to all study records, including source documents, for inspection and copying, in 
keeping with FDA regulations.  The Investigator should immediately notify the Sponsor of an 
upcoming inspection.  An auditing inspection may also be conducted by a representative of the 
Sponsor’s Clinical Quality Assurance Department. 
7.9 
Case Report Form Completion 
Case report forms are provided for each patient.  All forms must be legibly filled out in black ink 
or typed.  Data will be entered into the CRF as information becomes available on a visit-by-visit 
or course-by-course basis.  The Study Completion Information page of the case report form must 
be signed and dated by the Principal Investigator. 
All case report form corrections are to be made by an Investigator or other study site personnel.  
The Principal Investigator or sub-investigator must authorize changes to the recorded safety and 
efficacy data. 
The Principal Investigator or a Sub-investigator will sign and date the indicated places of the 
Case Report Form.  This signature will indicate that thorough inspection of the data therein has 
been made and will thereby certify the contents of the form. 
7.10 
Study Completion/Termination 
The Investigator will complete the study and submit the case report forms in satisfactory 
compliance with the protocol within an agreed upon time frame for each center after receipt of 
clinical supplies.  Continuation of this study beyond this time must be agreed upon by both the 
Investigator and the Sponsor and may be implemented without amendment to the protocol.  It is 
agreed that for reasonable cause, either the Investigator or the Sponsor may terminate this study 
before the above time, provided notice is provided at a reasonable time in advance of the 
intended termination. 
7.11 
Monitoring Procedures 
Clinical research staff (CRAs) designated by the Sponsor will visit the study center periodically 
to monitor adherence to the protocol and to applicable FDA regulations, and the maintenance of 
adequate and accurate clinical records.  Monitoring functions will be performed in compliance 
with recognized Good Clinical Practices.  The Investigator agrees to allow these CRAs, and 
other authorized Sponsor personnel, access to the clinical supplies, the investigational product 
dispensing and storage area, patient medical records, laboratory data, and other source 
documentation of the study patients.   
Case Report Forms will be reviewed in detail by the Study Monitor who will make a decision as 
to their acceptability.  If errors or omissions are found in the course of a data audit, or if 
clarification of data is required, the Case Report Form(s) in question will be corrected by the 
Investigator or designee.  Data Clarification or Query Forms may be generated for omissions or 
clarifications, to be completed and returned to the Study Monitor. 
The dates of monitoring visits will be recorded by the Study Monitor in a sign-in log to be kept 
at the site.  The Sponsor expects that, during monitoring visits, the study coordinator and 

CONFIDENTIAL AND PRIVATE INFORMATION OF SARANAS, INC. 
Page 43 of 63 
Protocol Number:  PVP004 
Original Protocol Issue Date:  May 4, 2018 
Investigator will be available, the source documentation will be available, and a suitable 
environment will be provided for review of study-related documents.  The Investigator agrees to 
assist Sponsor personnel in their duties, if requested. 
7.12 
Use of Information and Publication Policy 
The information provided in support of or generated as a result of this study is confidential.  Any 
use or reproduction thereof, including but not limited to publications or presentations by the 
Investigator or his associates, must be submitted to the Sponsor for review and approval prior to 
publication or presentation in any form.  All publications must acknowledge the sponsorship. 
All information not previously published concerning information such as patent applications, 
formulas, manufacturing processes, basic scientific data, and formulation information supplied 
by the Sponsor to the Investigator is considered confidential and shall remain the sole property of 
the Sponsor.  The Investigator agrees to use this information only to accomplish this study and 
will not use it for other purposes without the Sponsor’s written consent. 
The Investigator understands that the information developed in the clinical study will be used by 
the Sponsor in connection with the continued development of the study product, and may thus be 
disclosed as required to other clinical Investigators or government regulatory agencies.  To 
permit the information derived from the clinical studies to be used, the Investigator is obligated 
to provide the Sponsor with all data obtained in the study. 
7.13 
Ethical and Legal Considerations 
This study will be conducted in compliance with all applicable laws and regulations of the state 
and institution where the patient is treated, in accordance with the Declaration of Helsinki, and 
according to the guidelines in this protocol, including attached appendices. 
The investigator is responsible for the retention of the patient log and patient records; although 
personal information may be reviewed by authorized persons, that information will be treated as 
strictly confidential and not be publicly available. 

CONFIDENTIAL AND PRIVATE INFORMATION OF SARANAS, INC. 
Page 44 of 63 
Protocol Number:  PVP004 
Original Protocol Issue Date:  May 4, 2018 
8.0 
REFERENCES 
1. 
Nguyen CT, Lee E, Luo H, Siegel RJ. Echocardiographic guidance for diagnostic and 
therapeutic percutaneous procedures. Cardiovasc Diagn Ther. 2011;1(1):11-36. 
2. 
Roger VL, Go AS, Lloyd-Jones DM, Adams RJ, Berry JD, Brown TM, et al. Heart 
disease and stroke statistics--2011 update: a report from the American Heart 
Association. Circulation. 2011;123(4):e18-e209. 
3. 
Seldinger SI. Catheter replacement of the needle in percutaneous arteriography; a new 
technique. Acta radiol. 1953;39(5):368-76. 
4. 
Babu SC, Piccorelli GO, Shah PM, Stein JH, Clauss RH. Incidence and results of 
arterial complications among 16,350 patients undergoing cardiac catheterization. J 
Vasc Surg. 1989;10(2):113-6. 
5. 
Chandrasekar B, Doucet S, Bilodeau L, Crepeau J, deGuise P, Gregoire J, et al. 
Complications of cardiac catheterization in the current era: a single-center experience. 
Catheter Cardiovasc Interv. 2001;52(3):289-95. 
6. 
Vavalle JP, Rao SV. Impact of bleeding complications on outcomes after percutaneous 
coronary intervention. Interventional Cardiology. 2009;1(1):11. 
7. 
Kinnaird TD, Stabile E, Mintz GS, Lee CW, Canos DA, Gevorkian N, et al. Incidence, 
predictors, and prognostic implications of bleeding and blood transfusion following 
percutaneous coronary interventions. Am J Cardiol. 2003;92(8):930-5. 
8. 
Yatskar L, Selzer F, Feit F, Cohen HA, Jacobs AK, Williams DO, et al. Access site 
hematoma requiring blood transfusion predicts mortality in patients undergoing 
percutaneous coronary intervention: data from the National Heart, Lung, and Blood 
Institute Dynamic Registry. Catheter Cardiovasc Interv. 2007;69(7):961-6. 
9. 
Moscucci M, Fox KA, Cannon CP, Klein W, Lopez-Sendon J, Montalescot G, et al. 
Predictors of major bleeding in acute coronary syndromes: the Global Registry of 
Acute Coronary Events (GRACE). Eur Heart J. 2003;24(20):1815-23. 
10. 
Crudu V, Blankenship J, Berger P, Scott T, Skelding K. Complications related to 
access site after percutaneous coronary interventions: are the adverse events 
underreported? Catheter Cardiovasc Interv. 2011;77(5):643-7. 
11. 
Sherev DA, Shaw RE, Brent BN. Angiographic predictors of femoral access site 
complications: implication for planned percutaneous coronary intervention. Catheter 
Cardiovasc Interv. 2005;65(2):196-202. 
12. 
Kent KC, Moscucci M, Mansour KA, DiMattia S, Gallagher S, Kuntz R, et al. 
Retroperitoneal hematoma after cardiac catheterization: prevalence, risk factors, and 
optimal management. J Vasc Surg. 1994;20(6):905-10; discussion 10-3. 
13. 
Fruhwirth J, Pascher O, Hauser H, Amann W. [Local vascular complications after 
iatrogenic femoral artery puncture]. Wien Klin Wochenschr. 1996;108(7):196-200. 
14. 
Berry C, Kelly J, Cobbe SM, Eteiba H. Comparison of femoral bleeding complications 
after coronary angiography versus percutaneous coronary intervention. Am J Cardiol. 
2004;94(3):361-3. 

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Protocol Number:  PVP004 
Original Protocol Issue Date:  May 4, 2018 
15. 
Khoury M, Batra S, Berg R, Rama K, Kozul V. Influence of arterial access sites and 
interventional procedures on vascular complications after cardiac catheterizations. Am 
J Surg. 1992;164(3):205-9. 
 
 

CONFIDENTIAL AND PRIVATE INFORMATION OF SARANAS, INC. 
Page 46 of 63 
Protocol Number:  PVP004 
Original Protocol Issue Date:  May 4, 2018 
APPENDIX A: 
INVESTIGATOR AGREEMENT 
Provision of my signature below indicates my desire to participate in the clinical investigation of 
Saranas, Inc’s Early Bird Bleed Monitoring System and my agreement to all terms of this 
Investigator Agreement. 
I have thoroughly familiarized myself with the Investigation Plan (protocol) for the clinical study 
of the Saranas Early Bird Bleed Monitoring System and I believe that I am an individual who, 
because of my training and experience, is qualified to investigate the performance of the Saranas 
Early Bird Bleed Monitoring System under the purview of an appropriate Institutional Review 
Board (IRB) or Ethics Committee. 
I specifically and further agree that: 
1. I will conduct the clinical investigation in accordance with this Investigator Agreement, the 
Investigation Plan, the FDA IDE regulations, other pertinent FDA regulations, and any 
conditions imposed by my IRB, Ethics Committee or federal/state/local regulatory agencies. 
2. I will submit a copy of the written approval by my IRB/Ethics Committee of the 
Investigational Plan to the Sponsor prior to enrollment of the first patient. 
3. Prior to any study related procedure, I will obtain a signed Informed Consent from every 
patient, or his/her legal representative, who participates in this clinical investigation. 
4. I agree to complete all training required by the Sponsor in the use of Saranas Early Bird 
Bleed Monitoring System prior to treatment of the first patient.  I will review all 
investigational product and study-related documents sent to me by the Sponsor in a thorough 
and timely fashion and will provide the Sponsor with pertinent feedback when requested. 
5. All use of Saranas Early Bird Bleed Monitoring System will be under my direct supervision 
and according to the approved Investigational Plan. I will not allow access to Saranas Early 
Bird Bleed Monitoring System to anyone other than those employees of my institution who, 
under my direct supervision, are participating in this study. 
6. Only patients satisfying the study inclusion/exclusion criteria and willing to provide 
informed consent will be enrolled into this clinical trial. 
7. All information received from the Sponsor about Saranas Early Bird Bleed Monitoring 
System, and all knowledge obtained under or concerning this study including the study 
design, protocol, data, results, and any related written or orally-transmitted information, is 
considered the proprietary property of the Sponsor, and I will retain it in confidence and not 
release it to anyone without written consent from the Sponsor. 
8. I will ensure that investigational data are collected and recorded in a complete and accurate 
manner.  I will sign all case report forms as testimony to my review of investigational data.  I 
understand that it is necessary that investigational data be submitted to the Sponsor within 
seven days of collection so as to ensure a timely review and assimilation of results. 
9. I agree to personally meet with, and implement any corrective actions identified by, the 
Sponsor’s study monitors during periodic audits. 
10. Provide all required data and reports and agree to source document verification of study data 
with patient’s medical records by Sponsor (or designee) and any regulatory authorities. 

CONFIDENTIAL AND PRIVATE INFORMATION OF SARANAS, INC. 
Page 47 of 63 
Protocol Number:  PVP004 
Original Protocol Issue Date:  May 4, 2018 
11. I will submit interim and final reports to my IRB/Ethics Committee, the FDA and my federal, 
state, and local regulatory agencies as required by the conditions of approval from the 
respective agencies. 
12. Allow Sponsor personnel or its designees, as well as regulatory representatives, to inspect 
and copy any documents pertaining to this clinical investigation according to national data 
protection laws 
13. I will obtain written permission in advance from the Sponsor to publish or present any aspect 
of the Investigational Plan and study, including, but not limited to, animal or human study 
design, data, and results. 
14. I agree to fully comply with all of the responsibilities of Investigators outlined in the Code of 
Federal Regulations. 
I have never participated in any research project that has been terminated by an administrative 
body, financial sponsor, or regulatory agency for reasons of protocol noncompliance, 
misrepresentation of data, or any other reason. 
Printed Name of Investigator: 
 
 
 
 
Signature of Investigator: 
 
 
 
 
 
Date:  
 
 
 
 
 
 

CONFIDENTIAL AND PRIVATE INFORMATION OF SARANAS, INC. 
Page 48 of 63 
Protocol Number:  PVP004 
Original Protocol Issue Date:  May 4, 2018 
APPENDIX B. 
INSTRUCTIONS FOR USE 

English 
PPL001 (04/16/18) 
Page 1 of 15 
INSTRUCTIONS FOR USE (IFU) 
Saranas™ Early Bird™ Bleed Monitoring System 
CAUTION: “Investigational Device. Limited by Federal (or United States) law to 
investigational use.” per 21 CFR 812.5.  This product has not been approved for 
marketing in the United States, and is not available for commercial sale in the United 
States.   
Carefully read all instructions prior to use. Observe all warnings and precautions noted 
throughout these instructions. Failure to do so may result in complications. 
1 DESCRIPTION 
FIGURE 1: Early Bird™ Bleed Monitoring System 
The Early Bird consists of the following:  introducer sheath, user interface display (UID), 
for the early detection and monitoring of potential internal bleeding complications, and 
a dilator as shown in Figure 1. The introducer sheath contains four embedded 
electrodes. The distal end of the sheath has a tapered leading edge which transitions 
smoothly to the tapered dilator, forming an atraumatic device. The dilator is radiopaque 
to aid in visibility under fluoroscopy during insertion.  
User Interface 
Display 
Introducer 
Sheath with 
Embedded 
Electrodes 
Flush Line 
Dilator 
Sheath Hub 
Battery Pull Tab 
Page 49 of 63

English 
PPL001 (04/16/18) 
Page 2 of 15 
TABLE 1: Sizing Table 
Size 
(French) 
Minimum Sheath 
Internal Diameter, 
inches (mm) 
Working Length 
(cm) 
Working Length w/ 
Dilator (cm) 
6 
0.085 (2.16) 
20 
23 
8 
0.110 (2.79) 
20 
23 
14 
0.192 (4.88) 
20 
23 
2 PACKAGE CONTENTS 
•
Early Bird Bleed Monitoring System
•
Dilator
•
Directions for Accessing IFU
3 INTENDED USE 
The Early Bird is intended: 
•
to be inserted in the vasculature to provide a conduit for the insertion of
endovascular devices while minimizing blood loss associated with such
insertions.
•
to provide physicians with an early indication of extravascular fluid
accumulation, which may be due to a potential internal bleeding complication.
•
to detect and monitor changes in bioimpedance due to extravascular fluid
accumulation, and to provide physicians with indications that a potential internal
bleeding complication is progressing.
The Early Bird is intended to provide physicians and other healthcare providers with 
additional information to aid in their clinical assessment of the patient during and 
after endovascular access procedures.  As such, it is not intended to diagnose or 
replace clinical judgment of healthcare professionals. 
Physicians are encouraged to follow accepted clinical practices when treating a 
potential internal bleeding complication, including cessation or reversal of anti-
coagulants and application of pressure near the site of vascular access.   
4 INDICATIONS 
The Early Bird is indicated for use in endovascular procedures such as: 
•
Endovascular Aneurysm Repair (EVAR, including abdominal aortic aneurysms)
•
Transcatheter Aortic Valve Implantation (TAVI) or Replacement (TAVR)
•
Hemodynamic support devices such as intra-aortic balloon pump (IABP),
percutaneous ventricular assist device (PVAD) and enhanced extracorporeal
Page 50 of 63

English 
PPL001 (04/16/18) 
Page 3 of 15 
membrane oxygenation (ECMO) 
•
Percutaneous Coronary Intervention (PCI)
•
Transcatheter structural heart procedures such as balloon valvuloplasty, mitral
valve repair, or mitral valve replacement
•
Other similar procedures which utilize introducer sheaths to gain vascular access.
The device provides physicians with an early indication of a potential internal 
bleeding complication by initial detection and monitoring of extravascular fluid 
accumulation. 
5 CONTRAINDICATIONS 
•
Only one Early Bird may be used during a procedure. If more than one introducer
sheath is required simultaneously to perform a procedure, use a standard
introducer sheath in the secondary position.
6 WARNINGS 
•
Carefully read all instructions prior to use. Observe all warnings and precautions
noted throughout these instructions. Failure to do so may result in
complications.
•
Only physicians who have received appropriate training and are familiar with the
principles, clinical applications, side effects and hazards commonly associated
with vascular interventional procedures should use this device.
•
This device is not MRI compatible.
•
The Early Bird may not detect an Internal Bleeding Complication if internal
bleeding has already occurred prior to insertion of the introducer sheath or prior
to initial bioimpedance measurement.
•
The Early Bird should not be exposed to organic solvents.
•
Do not alter this device, including cutting to alter the length.  Alterations may
impair device function.
•
Do not attempt to place a guidewire with a maximum diameter greater than
0.035” (0.89 mm) through the dilator.
•
Do not attempt to insert a catheter or interventional device having a diameter
larger than the introducer sheath size (Table 1).  Device damage or breakage may
result.
•
Do not attempt to insert multiple catheters or interventional devices when the
combined diameter is larger than the introducer sheath size (Table 1).  Device
damage or breakage may result.
•
Do not attempt sheath advancement or withdrawal without guidewire and
dilator in place. Major bleeding, vessel damage or serious injury to the patient,
including death, may result.
Page 51 of 63

English 
PPL001 (04/16/18) 
Page 4 of 15 
•
Adequate vessel access is required to introduce the sheath into the vasculature.
Careful evaluation of vessel size, anatomy, tortuosity, and disease state
(including calcification, plaque, and thrombus) is required to ensure successful
sheath introduction and subsequent withdrawal.  If the vessel is not adequate
for access, major bleeding, vessel damage, or serious injury to the patient,
including death, may result.
•
Do not advance the sheath if the dilator is not snapped in the hemostasis valve
housing.  When the dilator is not snapped into the valve housing, the tip of the
introducer sheath may not be fully supported by the cylindrical section of the
dilator.  Therefore, advancement of the unsupported tip of the introducer sheath
may result in major bleeding, vessel damage, or serious injury to the patient,
including death.
•
Do not attempt to advance or withdraw guidewire, catheter, or other device
through the introducer sheath or dilator if resistance is felt.  Use fluoroscopy to
determine the cause.  Continued advancement or retraction against resistance
may result in major bleeding, vessel damage, serious injury to the patient, or
damage to/breakage of the guidewire, catheter, or other device.
•
Advance dilator and sheath assembly together with a twisting motion to
minimize vessel trauma.
•
Advance and remove sheath only under fluoroscopic guidance.
•
Use an appropriate wire guide to introduce additional guidewires through the
hemostasis valve alongside the previously placed guidewire, catheter, or other
interventional device.  Advancement of guidewires without the appropriate wire
guide through the valve may result in damage to the guidewire or the valve.
Damage to the valve could result in major blood loss.
7 PRECAUTIONS 
•
Do not attempt to advance sharp objects/instruments through the hemostasis
valve.  Sharp objects/instruments could cause damage to the valve and could
result in major blood loss.
•
Do not puncture the valve.  Puncturing the valve could result in major blood loss.
•
Examine packaging and device before use.  Do not use if either the packaging or
device is damaged, or if the sterile barrier has been compromised.
•
Do not use after the use by (expiration) date printed on the label.
•
Do not re-sterilize; for single use only.
•
The Early Bird is designed for single use only; do not re-use this device.  Saranas
does not have data regarding re-use of this device.  Re-use may cause device
failures or procedural complications, including device damage, compromised
device biocompatibility, and device contamination.  Re-use may result in blood
loss, infection, serious injury, or patient death.
•
To prevent or reduce the risk of clot formation, consider using systemic
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anticoagulation and keeping the introducer sheath filled with an appropriate 
heparinized flushing solution when it is in the vessel. 
•
Verify sheath, device, catheter, and accessory components size compatibility
prior to use.
•
Individual patient anatomy and physician techniques may require procedural
variations.
8 POTENTIAL ADVERSE EVENTS 
Adverse events that may occur and require intervention include, but not limited to: 
•
Blood loss, bleeding, hematoma
•
Embolization (micro or macro) with transient or permanent ischemia
•
Infection
•
Vascular trauma (i.e. dissection, rupture, perforation, tear, etc.)
•
Death
9 HOW SUPPLIED 
•
The Early Bird is supplied sterile and non-pyrogenic.
10 STORAGE AND HANDLING 
•
Store in a cool, dry place.
11 REQUIRED ACCESSORIES 
•
0.035” (0.89 mm) Guidewire
•
Heparinized Saline
12 DIRECTIONS FOR USE 
Sheath Preparation 
Verify the proper size introducer sheath is selected for the device to 
be introduced. 
Verify the vessel is of adequate diameter and tortuosity to 
accommodate the introducer sheath. 
Remove the introducer sheath and dilator from its packaging and 
examine contents for possible damage or defects.  
Caution: Do not use if damaged or defective. 
Caution: Do not pull the UID battery pull tab prior to insertion of the sheath 
into the vasculature and prior to suturing the sheath in place.  Once the 
battery pull tab is pulled, the device automatically powers on and allows 
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five (5) minutes for the bleed monitor to detect a bioimpedance signal 
before the device locks into an error state, after which, the device will not 
function as intended.  Refer to Section 13 if the device is in an error state.  
Prior to insertion, wipe down the introducer sheath and dilator with 
heparinized saline.  Do not wipe the surface with dry gauze. 
Flush the sheath through the stopcock with heparinized saline. Close 
the stopcock. 
Flush the dilator through the proximal hub with heparinized saline. 
Carefully insert the dilator tip through the hemostasis valve and into 
the sheath until the dilator hub is adjacent to the hemostasis valve. 
Gently snap the dilator hub into the hemostasis valve housing to 
ensure the tapered portion of the dilator is beyond the distal end of 
the introducer sheath making a smooth, atraumatic transition. 
Sheath Introduction and Use 
Using standard Seldinger technique, access the target vessel with the 
appropriate needle. 
Insert a 0.035” (0.89 mm) guidewire through the needle and into the 
vessel, then remove the needle ensuring the guidewire remains 
positioned within the vessel.   
Advance the distal end of the dilator over the guidewire. 
Advance the assembly (sheath/dilator) as a unit over the guidewire 
under fluoroscopic guidance; do not allow the dilator to back out of 
the sheath while advancing.  Use a slight twisting motion to advance 
the assembly through the tissue and into the target vessel.  Stop 
advancement of the assembly if resistance is felt.  Investigate the 
cause of resistance before proceeding.  Carefully advance the 
assembly until it is fully inserted.  
Caution: Do not attempt advancement of the sheath without the dilator and 
guidewire in place.  Major bleeding, vessel damage, or serious injury to the 
patient, including death, may result. 
Hold the sheath steady and maintain guidewire position while 
withdrawing the dilator from the sheath until it is completely 
removed from the guidewire. 
Aspirate and flush the introducer side-arm. 
Carefully suture the sheath in place to minimize device movement 
during use. 
Pull the battery pull tab to activate the Early Bird.   
Do not press the power button at this time.  The power button is 
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only used to turn off the device within the first five (5) minutes.   
Carefully support all guidewires, catheters, and other devices while 
advancing through the valve and sheath.   
Advance the selected interventional device over a guidewire through 
the valve and sheath.  Follow manufacturer’s recommendations for 
use of the selected interventional device.    
Caution: Do not advance or retract interventional devices into or out of the 
sheath if resistance is felt.  Determine the cause of resistance before 
proceeding. 
Caution: Do not attempt to advance sharp objects/instruments through the 
valve.  Damage to the valve may result in major blood loss.   
Caution: Advancement of guidewires without an appropriate wire guide 
through the valve may result in damage to the guidewire or the valve. 
Damage to the valve could lead to major blood loss.  
Sheath Removal 
Reintroduce a 0.035” guidewire, if not already placed. 
Insert the dilator over the guidewire and into the sheath and snap 
dilator into the sheath hub. 
Gently rotate the sheath to ensure the sheath is free from the 
vasculature. 
While maintaining the guidewire position, pull the sheath proximally 
until the sheath is fully removed.  The yellow Device Error indicator 
will illuminate, and the audible indicator will momentarily beep. 
During removal of the sheath, precautions should be taken to 
prevent excessive blood loss, vessel damage, or other serious injury.  
Follow standard clinical procedure to close the site after device 
removal. 
Follow standard hospital procedure for device disposal.   
13. FUNCTIONALITY
The Early Bird provides early detection of potential internal bleeding complications
and monitors for internal bleeding progression based on baseline bioimpedance
measurements and bioimpedance changes throughout the course of a procedure.
The device correlates the bioimpedance signal to changes in extravascular fluid
accumulation and displays bleeding status to the physician through a series of Light-
Emitting Diodes (LED’s) located on the UID (as shown in Figure 2).
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FIGURE 2: Early Bird™ UID 
TABLE 2: Indicator Descriptions 
LED/Indicator 
Description 
Bleed Monitoring 
(Red) 
The red Bleed Monitoring indicators are a series of three (3) 
LED’s that sequentially illuminate as bioimpedance 
continues to change over the course of a procedure, 
indicating a possible internal bleeding complication.  
•
Level 1 indicator (1st LED) is triggered by the early
onset of a bleed.  An audible alert is momentarily
activated once this level is triggered.
•
Level 2 indicator (2nd LED) is triggered as the bleed
progresses when a bioimpedance threshold is reached.
An audible alert, longer in duration than the 1st LED, is
momentarily activated once this level is triggered.
•
Level 3 indicator (3rd LED) is triggered as the bleed
continues to progress further when a higher
bioimpedance threshold is reached.  An audible alert is
activated once this level is triggered and requires the
attending physician to silence the device by pressing
the silence button.
Low Battery 
(Blue) 
The blue Low Battery indicator will blink when the battery is 
near end of life. The audible indicator will momentarily 
beep.  
Power Button 
Silence Button 
Low Battery LED 
Device Error LED 
Level 2 
Bleed 
Progression  
Level 3 
Bleed 
Progression  
Level 1 
Bleed 
Detection  
Power Indicator 
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If the system shuts down due to a low battery, the device 
has reserved enough power so that the system can be 
powered on to observe the last state of bleed monitoring 
indicators.  
Device Error 
(Yellow) 
The yellow Device Error indicator will illuminate when an 
internal system error has been detected.  The audible 
indicator will momentarily beep. 
If the yellow Device Error is illuminated, press and hold the 
Power button to turn off the device and turn the device back 
on for one additional attempted use of bleed detection and 
monitoring.  If the yellow Device Error illuminates again, the 
device cannot be used.  Once the procedure is completed, 
report the event to Saranas. 
Power 
(Green) 
The green Power indicator will blink after the device is first 
turned on and until it detects a bioimpedance signal which is 
in an acceptable range.  Then, the indicator will stop blinking 
and remain illuminated throughout the procedure. 
Button 
Function 
Silence 
This button is used to silence the audible indicator. 
Power 
After the battery pull tab is pulled, the system will run 
through a series of self-tests which will illuminate all 
indicators.  The audible indicator will momentarily beep. 
If required, press and hold the button to turn off the device.  
Note that the device can be turned off only within the first 
five (5) minutes after powering on the device. 
14. TECHNICAL DESCRIPTION
Battery
Battery Type: 
Alkaline 1.5V AAA 
Battery Life: 
Up to 12 hours 
The Early Bird battery is non-serviceable. 
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Electrical Safety 
ME Equipment Class: 
Internally Powered 
Patient Connection: 
Type BF 
The Early Bird Bleed Monitoring System (User Interface Display module and 
introducer sheath) is considered to be the Applied Part. 
Electromagnetic Compatibility (EMC) 
The Early Bird meets the requirements of IEC 60601-1-2 for a Group 1, Class A 
device.  Specific levels for the Early Bird device appear below. 
TABLE 3: Electromagnetic Emissions 
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions 
The Early Bird is intended for use in the electromagnetic environment specified 
below.  The customer or the user of the Early Bird should assure that it is used in 
such an environment. 
Emissions Test 
Compliance 
Electromagnetic Environment - Guidance 
RF Emissions 
CISPR II 
Group 1 
The Early Bird uses RF energy only for its 
internal function.  Therefore, its RF emissions 
are very low and are not likely to cause any 
interference to nearby electronic equipment. 
RF Emissions 
CISPR II 
Class A 
The Early Bird is suitable for use in all 
establishments other than domestic and those 
directly connected to the public low-voltage 
power supply network that supplies buildings 
used for domestic purposes. 
TABLE 4: Electromagnetic Immunity 
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity 
The Early Bird is intended for use in the electromagnetic environment specified 
below.  The customer or the user of the Early Bird should assure that it is used in 
such an environment. 
Immunity 
Test 
IEC 60601 
Test Level 
Compliance 
Electromagnetic Environment - 
Guidance 
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Electrostatic 
Discharge 
IEC 61000-4-2 
No false 
indications, 
error mode 
allowed: 
8 kV Contact 
15 kV Air 
Complies 
Floors should be wood, concrete or 
ceramic tile. If floors are covered with 
synthetic material, the relative 
humidity should be at least 30 %.  
Power 
frequency 
(50/60 Hz) 
magnetic field 
IEC 61000-4-8 
30 A/m 
50 or 60 Hz 
Complies 
If abnormal operation occurs, it may 
be necessary to position the Early Bird 
further from sources of power 
frequency magnetic fields or to install 
magnetic shielding.  The power 
frequency magnetic field should be 
measured in the intended location of 
use to assure that it is sufficiently low. 
Conducted RF 
IEC 61000-4-6 
3V 
0.15 to 80 
MHz 
6V in ISM 
bands 
between 
0.15 and 80 
MHz 
80% AM at 1 
kHz 
Refer to 
TABLE 5 
Portable and mobile RF 
communications equipment should be 
used no closer to any part of the Early 
Bird, including cables, than the 
recommended separation distance 
calculated from the equation 
applicable to the frequency of the 
transmitter.  
Recommended separation distance 
d = 1.2 √P 150 kHz to 80 MHz  
d = 1.2 √P 80 MHz to 800 MHz  
d = 2.4 √P 800 MHz to 2.5 GHz  
where P is the maximum output power 
rating of the transmitter in watts (W) 
according to the transmitter 
manufacturer and d is the 
recommended separation distance in 
meters (m).  
Field strengths from fixed RF 
transmitters, as determined by an 
electromagnetic site surveya, should 
be less than the compliance level in 
each frequency rangeb.   
Radiated RF 
IEC 61000-4-3 
3 V/m 
80 MHz to 
2.7 GHz 
80% AM at 1 
kHz 
Refer to 
TABLE 5 
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Interference may occur in the vicinity 
of equipment marked with the 
following symbol:  
NOTE 1: These guidelines may not apply in all situations.  Electromagnetic 
propagation is affected by absorption and reflection from structures, objects, and 
people. 
a Field strengths from fixed transmitters, such as base stations for radio 
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM 
radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.  
To assess the electromagnetic environment due to fixed RF transmitters, an 
electromagnetic site survey should be considered.  If the measured field strength in 
the location in which the Early Bird is used exceeds the applicable RF compliance 
level above, the Early Bird should be observed to verify normal operation.  If 
abnormal performance is observed, additional measures may be necessary, such as 
relocating to an alternate site. 
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 
V/m. 
TABLE 5: Recommended Separation Distances 
Recommended separation distances between portable and 
mobile RF communications equipment and the Early Bird 
The Early Bird is intended for use in an electromagnetic environment in which 
radiated RF disturbances are controlled. The customer or the user of the Early Bird 
can help prevent electromagnetic interference by maintaining a minimum distance 
between portable and mobile RF communications equipment (transmitters) and the 
Early Bird as recommended below, according to the maximum output power of the 
communications equipment.  
Rated 
maximum 
output 
power of 
transmitter 
Separation distance according to frequency of transmitter 
m  
150 kHz to 80 MHz 
80 MHz to 800 MHz 
800 MHz to 2.5 
GHz  
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W 
d = 1.2 √P 
d = 1.2 √P 
d = 2.4 √P 
0.01 
0.12 
0.12 
0.24 
0.1 
0.38 
0.38 
0.76 
1 
1.2 
1.2 
2.4 
10 
3.8 
3.8 
7.6 
100 
12 
12 
24 
For transmitters rated at a maximum output power not listed above, the 
recommended separation distance d in meters (m) can be estimated using the 
equation applicable to the frequency of the transmitter, where P is the maximum 
output power rating of the transmitter in watts (W) according to the transmitter 
manufacturer.  
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency 
range applies.  
NOTE 2: These guidelines may not apply in all situations. Electromagnetic 
propagation is affected by absorption and reflection from structures, objects, and 
people.  
Impedance Measurement 
Applied signal waveform:  
10.0 kHz, sinusoidal 
Applied signal amplitude: 
250 μA peak to peak 
Impedance sampling rate: 
0.25 seconds 
Impedance measurement range: 
10 to 95 ohms, -20 to +20 degrees phase 
Permissible Environmental Conditions 
Temperature:  
Transportation and Storage: -29°C to 60°C 
Relative Humidity: 
 
Transportation and Storage: 0% to 85% 
Atmospheric Pressure: 
Transportation and Storage: 50kPa to 106kPa 
Operating Conditions: Typical operating room / catheterization laboratory environment 
WARNING: No modification of this equipment is allowed. 
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15. DEVICE RELATED ADVERSE EVENT REPORTING
Any adverse event involving the Saranas Early Bird Bleed Monitoring System should be 
reported to Saranas, Inc. immediately.  To report an event in the United States, please 
call 713.357.1049, e-mail info@saranas.com, or write to: 
Saranas, Inc. 
2450 Holcombe Boulevard 
Suite X 
Houston, TX 77021-2039 
USA. 
TABLE 6: Symbol Descriptions 
SYMBOL 
DESCRIPTION 
Catalog Number 
Batch Code 
Use by Date 
Quantity 
Manufacturer 
Maximum I.D. (French Size) 
Guidewire Compatibility 
Do Not Re-use 
Do Not Use if Package is Damaged 
Keep Dry 
Do Not Re-sterilize 
Temperature Limit 
Humidity Limitation 
Atmospheric Pressure Limitation 
Consult Electronic Instruction for Use (www.saranas.com/IFU) 
Caution 
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SYMBOL 
DESCRIPTION 
Keep Away from Sunlight 
Caution: U.S. Federal Law restricts the sale, distribution, or use of 
this device to, by, or on the order of a physician. 
Sterilized using Ethylene Oxide 
Type BF Applied Part 
IP41
Ingress Against Water or Particulate Matter (IP) Classification 
Protected against solid foreign objects of 1.0 mm ∅ and greater 
and protection against vertically falling water drops 
RoHS
Restriction of Hazardous Substances 
General Prohibition Sign, i.e. Do Not… 
General Warning Sign, i.e. Caution… 
MR Unsafe 
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