Belter Health Measurement and Analysis Technology JK1V VENDYS II User Manual

Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. VENDYS II

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VENDYS II
Operation Manual- VENDYS Portable
Table of Contents
VENDYS® Support.......................................................................................................................................4
Technical Information..............................................................................................................................5
Operating the Device ................................................................................................................................5
Cleaning .........................................................................................................................................................6
Cleaning the Cuffs ................................................................................................................................................. 6
Indication of Use.........................................................................................................................................6
Preparation and Optimal Conditions for VENDYS Test ................................................................7
Factors affecting vascular reactivity:............................................................................................................. 7
Subjects preparation: .......................................................................................................................................... 7
Environmental Conditions: ............................................................................................................................... 7
VENDYS Assembly Instruction...............................................................................................................7
Introduction to theJK001V device .................................................................................................................. 7
Preparation ........................................................................................................................................................... 12
Assembly:............................................................................................................................................................... 14
Probes connection .......................................................................................................................................................... 14
Cuff Connection ................................................................................................................................................................ 14
Power Connection ........................................................................................................................................................... 14
System Check .................................................................................................................................................................... 14
Cold Finger Kit ..................................................................................................................................................... 15
Non‐Invasive Infrared Temperature Gun ............................................................................................................. 15
Electric Heating Blanket ............................................................................................................................................... 15
How is This Kit Used? .................................................................................................................................................... 15
VENDYS II Test Procedures ................................................................................................................. 16
Set up an Operator.............................................................................................................................................. 16
Turn on VENDYS Machine ........................................................................................................................................... 16
Admin Login ...................................................................................................................................................................... 19
Set up the Name of the Clinic .......................................................................................................................... 22
Start a VENDY Test (Login as Operator) ..................................................................................................... 23
Test Preparation‐‐‐Optimal Conditions ................................................................................................................. 23
Finger Size Selection ...................................................................................................................................................... 26
Cuff Placement .................................................................................................................................................................. 27
SubjectTemperature Sensor Setup .......................................................................................................................... 28
Fingertip Temperature Sensor Attachment ......................................................................................................... 29
Lap Pad Setup ................................................................................................................................................................... 30
Patient Demographic and Health Information .................................................................................................... 31
Blood Pressure Measurement .................................................................................................................................... 33
VENDYS Vascular Function Test ............................................................................................................................... 35
VENDYS II Graphic User Interface ..................................................................................................... 51
Login Page ............................................................................................................................................................. 51
Login ..................................................................................................................................................................................... 51
Video Gallery ..................................................................................................................................................................... 53
Tutorial ................................................................................................................................................................................ 54
Contact Us........................................................................................................................................................................... 56
VENDYS II Main Page ......................................................................................................................................... 57
Add Operators .................................................................................................................................................................. 57
Settings ................................................................................................................................................................................ 61
Tutorial ................................................................................................................................................................................ 68
Contact Us........................................................................................................................................................................... 68
Video Gallery ..................................................................................................................................................................... 68
Patient Records: ............................................................................................................................................................... 68
Troubleshooting ...................................................................................................................................... 75
Cannot get info from Probes ........................................................................................................................... 75
Low Battery ........................................................................................................................................................... 75
Battery problem .................................................................................................................................................. 75
Failed to get information from SD card ...................................................................................................... 75
Cannot turn on the machine ........................................................................................................................... 75
The monitor cannot display very well after turning on the machine .............................................. 75
The screen is stuck on the booting video page......................................................................................... 75
Keypad is not coming out while typing ....................................................................................................... 75
VENDYS keeps rebooting after turning on................................................................................................. 75
Touch screen is not working........................................................................................................................... 76
Blood pressure cuff cannot be inflated ....................................................................................................... 76
Cuff leakage problem......................................................................................................................................... 76
Inappropriate placement of BP Cuff (other cuff problems) ................................................................ 76
Technical Information: ......................................................................................................................... 77
Temperature Probes (RTD) Specification ................................................................................................. 77
VENDYS II Machine Specification .................................................................................................................. 77
Product Labels ..................................................................................................................................................... 78
Packing List for VENDYS System ........................................................................................................ 79
Appendix A: License Agreement and Limited Warranty ........................................................... 80
VENDYS® Support
If you have any questions regarding the setup and/or operation of the VENDYS®
device, pleasecontact:
Endothelix Customer Support
713-529-2599
http://support.endothelix.com
support@endothelix.com
Technical Information
This manual describes the function of the VENDYS-II JK-001Vvascular function
testing device (hereafter referred to as VENDYS-II): performance, operation method
and other safety information content.
Operating the Device
 VENDYS-II can be powered by a built-in battery or an AC power supply. The
device is easy to carrywith a built-inhandle.
 The device is not a therapeutic device,it is intended for measurement purposes
only.
 This equipment is suitable for adults and children over the age of 12 and not
for use onyounger children and infants.
 To prevent personal injury or equipment damage, make sure the device is
properly placed on a sturdy surface. Improper placement may result in
equipment damageand/or personal injury.
 Do not place or operate the VENDYS-II device in the vicinity ofmagnetic
resonance imaging (MRI) equipment, as the induced currents can result in
severe injuries orburns to thetesting personnel.
 Do not place or operate the device in the presence of flammable substances,
flammable anesthetic gases or other open-gas appliances.
 Do not place or operate the device in the presence of strong electromagnetic
radiation devices.
 To prevent injury, device operation and maintenance is strictly reserved for
qualified technical personnel.
 The device may only be used with the original supplied power adapter and
power cord. Do not attempt to operate the device using other power cords or
adapters.
 Pay attention to the placement of the power cords, catheters and all other
cables. Keep liquids and other potentially dangerous objects away from the
device in order to prevent personal injury. In the case of liquid spilling and
contacting the device, disconnect the power immediately and contact service
personnel.
 To prevent the device from overheating, keep away from all objects that may
obstruct the back ventilation area of the device.
 Do not open the instrument shellin order to avoid the possible risk of electric
shock. All instrument maintenance and upgradesare reserved for trained and
authorized service personnel.
 Prior to device operation, thoroughly inspect the equipment and its accessories.
 Thedevicetest results are for reference only. The results cannot be used as a
diagnosis.
 Be sure to properly connect all cables to the device.
 Keep device packaging away from children and properly dispose of unwanted
packaging in accordance with current waste control regulations.
Cleaning
Blood pressure cuffs are listed as low-risk and non-critical items for disinfection.
That being said, recent research has found them to be key in the spread of MRSA (an
antibiotic-resistant bacteria) in hospitals. The proper cleaning of these cuffs ensures
that dangerous bacteria does not spread between patients. Endothelix does not
assume responsibility for the effectiveness of these chemicals as a means of control
of infectious diseases. Follow Guideline for Disinfection and Sterilization in
Healthcare Facilities published by United States Center for Disease Control.
Cleaning the Cuffs
1. Prepare amild detergentand distilled water solutionand a 10% bleach
solutioninseparate spray bottles.
2. Spray detergent solution on cuff, tubing and hose.
3. Wipe smooth surfaces with a soft cloth. Use a soft bristle brush on visibly
soiled areas and irregular surfaces;
Note: Do not allow fluid to enter the cuff tubing or cuff.
4. Rinse with distilled water.
5. To disinfect, spray 10% bleach solution on cuff and allow to sit for 5 minutes
6. Wipe excess solution and rinse with distilled water.
7. Let dry thoroughly for 2 hours.
Indication of Use
VENDYS® is a non-invasive, digital, electronic thermometer and non-invasive blood
pressure measurement device.This device is used to continuously and simultaneously
measure surface temperature at multiple sites (e.g. fingertips on the test and control
hands) and also measure blood pressure at the brachial artery.
It is intended to be used for measurement of vascular reactivity by monitoring
temperaturechanges before, during, and after a reactive hyperemia test, using a 2-5
minute cuff occlusion procedure, and calculates multiple indices based on
temperature changes.
The VENDYS® device is intended for use by competent healthcare professionals in
a clinical or research setting. It is intended to supplement, not substitute for, the
physician’sdecision making process, and it should be used inconjunction with the
patient’s history and other clinical findings.
Preparation and Optimal Conditions for VENDYS Test
Factors affecting vascular reactivity:




Ambient temperature
Time from food intake
Drugs
Sympatheticstimuli
Subjects preparation:






Rest for at least 6 hours before the TEST
Do not exercise for 6 hours before test
Do not exercise during the test
Betestedina quiet, temperature-controlled room
Withhold all vasoactive medications forat leastfourhalf-lives
Do not ingest substances that might affect vascular reactivity such as caffeine,
high-fat foods and vitamin C or use tobacco for at least 4 to 6 hours before the
test
Theoperatorshould be cognizantof thephase of the subject'smenstrual cyclewhich
mayaffect the response. These confoundingfactorsmust be considered inpreparinga
subjectforstudiesthat seek to determine the impactof asingle intervention.
Forobservationalcohortstudies, datamust be collected onthose factorsknown to
affectthemeasurementof response, and analysisshould addresstheirimpact.
Environmental Conditions:
Ambient roomtemperature should be keptconstant at/around 24°C.Bright lights,
movementofother people, fans, direct sunlight,or beingseated near an ACventmay
cause mental stressand affectthetestresults, sotheyshould beavoided. It may be
helpful todimthelightsor have the patient wearingheadphones.
The
environmentshould be calmandstable.
VENDYS Assembly Instruction
Introduction to theJK001V device
Figure 1-1 Front view
Number
Function
Power switch button
Volume increase button
Volume decrease button
Statusindicator (Blue indicates the device is on. No light
indicates the device is turned off).
Charging status Indicator(Blue indicates the device is
charging; Green indicates charging is complete)
Speakers
7
Device label
Return button
Servicebutton (no effect in normal operation)
10
Emergency shut-off button
11
Microphone
12
Camera
13
LCDscreen
Figure 1-1 Right-side view
Number
Function
USB port
HDMI port
Micro-USBport
SD card slot
Null
Ethernet cable port
DC power input port
10
Figure 1-3 Rear-view
Number
Function
Handle
Built-in storage latch
Back coverplate
Nameplate
11
Figure 1-4 Left-side view
Number
Function
Probe HDMI connection
Cuff NIBP hose connection
Preparation
Carefullyremove all components from the packagingto obtain the VENDYS II
machine and corresponding VENDYS probes and cable. Please check necessary items
according to the packing list (provided in the package) and make sure all the items
included in this package are received. At the same time, please check if any
mechanical damages happened to the VENDYS machine.If any, please contact
Endothelix support to receive a replacement.
12
All words should be written in English
13
Assembly:
Probes connection
Connect the Probes to the HDMI port on the left side of the VENDYS II machine.
Cuff Connection
Connect the cuff to the NIBP port on the left side of the VENDYS II machine.
Simply insert the air tube into the port until you feela click.
Power Connection
Connect the power and adaptor cable to the port marked ‘DC 24V’ on the right side
of VENDYS II machine. Plug the power cable into a wall outlet.
System Check
After plugging the power cable into a wall outlet, the bottom left light on the front of
the device should turn blue.
If the blue light does not appear, make sure all components are properly connected. If
you still require assistance refer to the Support section at the end of the QuickStart
guide.
14
Cold Finger Kit
Non-Invasive Infrared Temperature Gun
Non‐invasive infrared temperature gun can be used to detect the fingertip temperature
quickly before the VENDYS test. Once the cold finger is detected (The temperature of
fingertip is below 27 Centigrade), heating blanket should be applied to warm up the patient.
Cold finger might cause the vessel constriction during the VENDYS test, thus affecting the test
results.
Electric Heating Blanket
Electric heating blanket is applied to the patient shoulder and neck to warm up the patient
when they suffer from cold finer (The fingertip temperature of the patient is below 27
Centigrade) and prepare the patient with the following VENDYS test. Please apply the electric
heating blanket to the patient as the following instruction.
How is This Kit Used?
Cold Finger Kit is used before the VENDYS test. First, measure the fingertip temperature of
patient before the VENDYS test.
15
1. If the patient fingertip temperature is above 27 centigrade, which suggests
he/she is ready for the VENDYS test.
2. If the patient fingertip temperature is below 27 centigrade, the heating
blanket should be applied to warm up the patient for few minutes. Once the
patient’s fingertip temperature is above 27 Centigrade, they are ready for the
VENDYS test.
VENDYS II Test Procedures
Set up an Operator
Turn on VENDYS Machine
1. Press and hold the “
” button on the right side of the device for a few
seconds until the following page shows up.
2. This page will last for 3 seconds. Then the following page will show up, this
page will also last for 3 seconds.
16
3. A short video will show up after the second introduction page, this short video
will last 60 seconds, which will give you a brief introduction to the VENDYS
test.
17
4. After that, the login page will show up as follows:
18
Admin Login
1. After touchingthe green “Login” button in the middle of the login page, it will lead
you to the following login page.
There are three options for the customer to choose:
1. Superadmin: this is for the Endothelix technical support.
2. Admin: this is for the administrator of local clinic.Additional operators can
be added via this account
3. Operator(s) (This option will show up after adding operators on the
following main page)
2. Please choose the “admin” as the “User Name”. The default password for “Admin”
is “888888”.
User Name
admin
Password
888888
After that, click on “OK” to enter the VENDYS II system and the following main
page will show up:
19
3. Click on “Add Operator” orange button on the left top of the screen, the following
page will show up.
20
4. Click on the Blue “Plus” button on the left top of the screen, the following page
will show up.
5. Input the required items on the pop-up windows, including operator name, email,
email password, operator password, and confirm password. Then Click the “Save”
Button.
6. Click on the “Return” button to go back to the Main Page as follows:
21
Set up the Name of the Clinic
3. Click on the purple tools icon on the left side of the screen, the following page
will show up
22
2
Make units selections and input the Clinic information, including name, address,
telephone, email, website. And then click on the “Save” button on the top right
side of the screen. The name of the clinic will show up at the VENDYS test
report.
Click on the “Return” on the bottom of the screen and go back to the main page.
Click Back button at lower right side to return to login page. Logout then login as
operator.
Start a VENDY Test (Login as Operator)
Test Preparation---Optimal Conditions
1. After login as the operator, the following page will show up
23
2. After clicking on the green button in the middle, the following page will show
up. Choose existing patient/new patient based on your current condition.

If an existing patient is chosen, the following page will show up.Scroll up and
down to select an existing patient in the system. After clicking on the existing
patient, the following page will show up, at the same time, the instructional
audio willbe played. The instruction audio is “Please sit comfortably with your
24
hands on the insulated pad either on your lap or to your sides. A reclining
chair with arm rests is an optimal position but you may also lie down on a bed.
Optimal room temperature is between 22-24 centigrade or 71-75 Fahrenheit. If
you feel cold or slightly cold it is strongly recommended to warm up by
covering the shoulders and back of the neck with blankets. The room should
be quiet and ideally with dim lighting. You should feel relaxed and
comfortable. Please pay attention to the next few steps.”
 If this is your first time running thetest, please click on “New Patient”. After
clicking on this page, the instruction audio will be played. The audio is the
same with existing patient.
25
1.
2.
3.
4.
5.
6.
Last step: Click here to go back to the previouspage of the system
Next Step: Click here to go to the next instruction page
Optimal condition: Click here to get the text of the audio file.
Probe SN: This is the serial number for the attached probe
Tests available: This is the number of tests available for current probe
Blood pressure information: These valueswill show up after doing the BP
measurement.
7. Temperature:
 RF-Temp: Right fingertip temperature
 LF-Temp: Left fingertip temperature
 RM-Temp: Room Temperature
Finger Size Selection
After clicking on “Next Step”, the following page “Select Finger size” will show up
and instructional audio will be played automatically.
26
“Please place your right index finger on the screen and choose the closest size by
tapping the image that most closely matchesyour finger. Then tap on “Next step””
1. Last step: Click here to go back to the previous instruction page
2. Next Step: Click here to go to the next instruction page
3. Finger size picture: Place your right index finger on the screen and choose the
closest size by tapping the image matches your finger
Cuff Placement
After clicking on “Next Step”, the following page “Cuff Placement” will show up
and the instructional audio will be played automatically.
27
“Please make sure the cuff is placed properly on the right upper arm and then tap on
“Next step”.”
1. Last step: Click here to go back to the previous instruction page
2. Next Step: Click here to go to the next instruction page
SubjectTemperature Sensor Setup
Attach a disposable adhesive clipto theprobe body asfollows. Make sure thatthe
raisedside of theclipistowardtheprobe cable
Removetheadhesive covers.
28
Placing thetemperature probes
1. Positionthe probeonthesubject’sindexfinger asfollows: Make sure that the
center of the probe is located on the pulp of the finger
2. Place temperature probe (red tag) on the subject’s right index finger
a. Probe 1 should always be placed on the occluded arm
b. Ensure that the sensor portion of the probe is located on the pulp of the
finger.
3. Place temperature probe (blue tag) on the subject’s left index finger. Ensure
that the sensor portion of the probe is located on the pulp of the finger.
Fingertip Temperature Sensor Attachment
After clicking on “Next Step”, the following page “attachment of the probes” will
show up and the instructional audio will be played automatically.
29
The instruction audio is “Please attach the temperature probe with red sticker on the
right index finger, blue for the left finger. Then tap on “Next step”.”
1. Last step: Click here to go back to the previous instruction page
2. Next Step: Click here to go to the next instruction page
Lap Pad Setup
After clicking on “Next Step”, the following pagewill show up and instruction audio
will be played automatically “put the hands on the insolation pad”.
30
The instruction audio is “Please put both hands on the smooth side of the insulation
pad. This will keep heat from your body and legs not to interfere with the fingertip
temperature measurements. Tap on “Next step”.”
1. Last step: Click here to go back to the previous instruction page
2. Next Step: Click here to go to the next instruction page
Patient Demographic and Health Information
After clicking on the “Next step”, the following page will appear to ask you to fill
out the patient information and instruction audio for this part will be played
automatically.
The instruction audio is “Please select which of these medical conditions are
applicable. Check all choices that apply.”
1. Last step: Click here to go back to the previous instruction page
2. Next Step: Click here to go to the next instruction page
3. Main Page: Click on this button to go back to the main page of the system.
31
4. Notes: Include other medical or basic information which is not included in the
list above.
32
Blood Pressure Measurement
A non-invasive blood pressure test will be performed in this screen. The systolic
blood pressureobtained after this screen will be used to determine the inflation
pressure of the pneumatic cuff onthe right arm during the VENDYS test. The
software will add 35mmHg to the systolic blood pressureand the result would be
used as the set pressure in the right arm cuff for the VENDYS test. Thistechnique is
a safeguard to make sure that the proper occlusion has been reached.
Before doing the blood pressure measurement, please make sure the cuff is placed on
the patient arm.
After clicking on the “Next step”, the following page will appear to do the Blood
Pressure measurement. The instruction audio will be played automatically, which is
“We are about to measure your blood pressure. This step is a standard automated
blood pressure measurement. There are 3 different cuff sizes: extra-large, large and
small. Please verify that the cuff size is appropriate to your arm size. Please make
sure that the cuff is correctly wrapped around the arm: not too tight and not too
loose. Please sit or lie comfortably and relax while your blood pressure is measured.”
1. Last step: Click here to go back to the previous instruction page
2. Next Step: Click here will allow you to continue on to theVENDYS test once
the blood pressure has been calculated ormanually entered.This button will not
be enabled until the blood pressure iscalculated by the blood pressure test or
entered manually.
3. Blood Pressure Graph: Displays the graph of the pressure in the cuff over time
33
4. Start: Click on this button to start the automated blood pressure measurement
5. Manual Entry:If the Manual Entry button is pressed, the blood
pressuremeasurements will have to be taken manually and the resultsshould be
input into the program manually in the screen shownlater on the page
6. Main Page: Click here to go back to the main page of the system.
7. Blood Pressure Results: When test is complete, this chart will display the
systolicpressure, diastolic pressure, calculated mean blood pressure, andpulse
rate on the right middle of the screen.
If the manual entry button is clicked,the following screen will appear. The manual
Entry button will turn into yellow, which suggests that this feature is enabled. Enter
the systolic, diastolic, and then enter the pulse rate. The mean blood pressure will be
computed and displayed. Click “Done” on the keyboard to use these results for the
VENDYS test. If you change your mind and want to measure your blood pressure
using the automatic blood pressure measurement, just click on “Start” to start the
measurement.
Start the Blood Pressure Measurement
After clicking on the “Start” buttonat the end of the screen, the blood pressure
measurement will be done automatically. And then the following page will show up.
The data received from the measurement will show up at the right side of the screen
automatically.
34
1.
2.
3.
4.
Systolic pressure: the systolic pressure of the client
Diastolic pressure: the diastolic pressure of the client
Mean pressure: the mean pressure of the client
Pulse rate: the pulse rate of the client
VENDYS Vascular Function Test
After blood pressure measurement, clicking on “Next Step” button.
When the “Next Step” button is clicked, the following screen is displayed:
35
1.
2.
3.
4.
5.
6.
7.
8.
9.
Main Page: Click on this button to go back to the main page
Start: Click “Start” to allow the VENDYS test to begin
Probe SN: Displays the serial number of the temperature probes
Test available: Displays the available tests for the current probes
Cancel: Stop Test button will show up after clicking on the “Start” Button. If
for any reason you wish to stop the test, click Stop Test.
Time: This section will display the amount of time remaining within the
current phase of the VENDYS test and the time remaining for the whole test to
be completed.
Temperature Graph: Displays the temperature versustime through the three
phases ofthe VENDYS test.The red trace indicates the right (occluded arm)
finger temperature,while the blue trace indicates the left (non-occluded arm)
fingertemperature.During the three phases of the test, the first five minutes is
thestabilization period. The lines for both hands should indicate astable (nearly
flat)baseline and similar temperatures in both hands.During the inflation
period, the red line should show a nearly lineartemperature drop (after about
30 sec) while the blue light remains nearly constant,indicating a temperature
drop in the occluded hand. During thefinal deflation period, the red lineshould
display a returnto baseline temperature after the occlusion is released.
Blood pressure measurement results: The systolic, diastolic pressure, mean
pressure, pulse rate will be displayed here.
Temperature Sensors: Shows the temperature readings as numerical values
from thefinger probes in real time. The red reading indicates thetemperature in
36
the right, occluded hand. The bluereading indicates the temperature in the left,
non-occluded hand. The white reading indicates the room temperature.
10. Flags: Displays any warning flags that may have been activated duringthe test.
(Please refer to Description of Warning Flags section.)
11. Cuff Pressure: Cuff pressure button will show up on the “mean pressure”
locationafter clicking on the “Start” Button, which stands for the cuff pressure
on the right arm.
Start a VENDYS Test
When“Start”isselected,theVENDYS test will begin.
Thetemperature probeswill begin to measure thefingertiptemperature and the
applicationwill determine the temperature stability based onthe input value fromthe
TestSetup form. Once the fingertiptemperaturestabilizes, theocclusion cuffwill
inflate totheselectedsupra-systolic increment.The cuff inflatesinabout 4seconds,
andthepatient’sfinger temperatureshould begin to decline in about 30 seconds.
Thenumericvaluesfor these readingsand room temperature are displayed to the
right bottom of the graph.Thedata isplotted inreal time on the autorangingchart
andstoredinalocal programarrayfor the final display, storage andanalysis.
There are three phasesofthe test. During thefirststabilizationsection, the linesfor
both hands should displayastable,flat baseline. Inthe followingocclusionsection, the
red line for theright hand should displayalinear temperature drop, while the blue
(left hand)line should remainstable. Inthe third section, the red line should showa
quickreturn to the baseline temperature after occlusion.
37
If any time during the test, the patient complains about the excessive pain or the test
needs to be stopped for any reason, both arm cuffs and finger probes should be
removed immediately. Pressing the “Cancel” button will deflate the cuffs and abort
the test. If the touch screen is not working, please click on the red panic button on
top right of the machine to force shut down the machine.
Thetimersatthebottomof the page will showthe time remainingfor the phase and the
whole test. The software is coming along with the tutorial audio. After clicking on
the “Start” button on the screen, the following audio will come out saying “Please
close your eyes and try to relax, the test is about to start. You are now in the
stabilization phase. This phase will last for 5 minutes. If you are feeling cold please
let the operator know.” After thestabilizationphase iscomplete, the program will emit
a soft sound to alert the patient that the occlusion phase is about to begin, which is
“The occlusion phase is about to start. The cuff is about to be inflated. You are now
in the occlusion phase. This phase will last for 5 Minutes. You may feel numbness
and tickling in your right hand due to occlusion. These are normal symptoms one
experiences during these 5 minutes. Please do not worry and try to relax”. In the
middle of the occlusion phase, another audio message will come up and saying
“You're half way through the 5 minutes. Please be patient and try to think about
your happy moments! Enjoy the music and rest assured the feelings you're having
in your right arm and hand will be gone soon after releasing the cuff. ” to assure the
patient. 30s away from the end of the second phase, the audio guidance will show
up and saying “You are now 30 seconds away from the end of this phase. Please
continue to relax”, the same reminder will come up 10s before the end of the
occlusion “The cuff will deflate in 10 seconds; please do not move your hands
during the deflation phase.”
38
The guidance sound will be heard after the occlusion phase is complete to alert the
patient that the deflation phase is about to begin. “The deflation phase is about to
start. The cuff is about to be deflated. ”, After that, “Congratulations! You are now in
the deflation phase. This phase will also last for 5 minutes. You will notice your right
lower arm and hand may become turning red due to the restoration flow of the warm
blood. In fact, there will be more blood rushing to your forearm and hand than the
usual. The more blood the more the temperature rebound. After 1-2 min, the redness
will disappear and your hand and arm will return to normal. Please relax until the test
is completed. It is very important that you feel relaxed in this period which the
VENDYS test measures your response.”Whenthe occlusiontimehaselapsed, thecuff
automatically deflates.Theprogramcontinuesto acquire thetemperature dataand plot
itto
thestripchartandstoreitin
thelocal
array.
Thiswill
continue
until
thePostDeflationTimeisreached.
Theprogramtracksthesechangesasspecified by thetestsettings. Once the test
iscomplete, the programexecutesseveralfunctions:
Re-plotall the dataontoonescreenwidth
Calculatethevarioustemperature and time values
Displayany warningflagsfor the test
Sendall informationto thedatabase
Sendtheentire arrayof testdata to thetextdata file
Once the testhasbeen completed, the following messagewill be displayed:
This message indicates that the test is complete and the final report will be created if
the test is saved. After clicking on the “View the report” button, the final report will
be displayed.
39
Note: Clicking the Main Page before the VENDYS test is complete will result in
the test being canceled and not saved.
Description of WarningFlags
WarningFlags
Description
Cold Finger
Thisflagis triggered if the right
fingertemperature drops below27°C
during
the
temperature
stabilizationperiod.
Published
literature and our internal testinghave
indicated that a subject may be ina
vasoconstrictive state if the finger
temperature declines below27°C
priorto theonset of cuffocclusion. A
vasoconstrictive
state
may
adverselyaffectthe
assessmentof
vascular reactivityindex.
Recommendation: We do NOT
recommend savinga test in which
thisflaghas beentriggered because the
skinsurface temperature may not be a
40
correct indicator of normalblood flow.
SympatheticResponse
Redflagindicatesa constant decrease
in theleft finger temperatureduringand
after cuff occlusion.
Thisflagevaluates
the
leftfinger
temperature curve. If the left finger
temperature steadily declines after the
rightarmcuff is deflated, this may
indicate that the subject isexhibiting
signs of excessive sympathetic
nervous activity, which will result in
vasoconstriction. When thisflagis
triggered,
werecommend
that
youevaluate
the
RIGHT
fingertemperature curve; if the right
temperature curvereturns to baseline
post-cuff deflation, thenthistestcan be
saved. However, if the right
temperature curve neverreturns to
baseline, the test should not be
savedand the entire test should be
repeated at alatertime.
Right vs. Left Delta
Whentriggered, thisflag indicates that
the temperature difference between
right and left fingers is greater than
3°Cduring
the
temperature
stabilizationphase of thetest. This may
meanthat a probe has moved orlost
firmcontactwith the skinsurface.
Recommendation:Evaluate
the
positionof thetemperature probesand
make sure the probesare adhering well
to the skin surface. If either probe
needed to be adjusted, the entire
testshould be repeated.
Baseline Stabilization
Redflagindicates
that
thefinger
temperature neverreached a stable
valueinthe time allotted for stability.
41
A relativelyflat temperature curve
during the two– minute time period
before
cuff
occlusion
usually
indicatesstability.
Cold Room
Red flag indicates that the room
temperature was below 22 °C for
some time during the test. A cold
room may cause the subject to enter a
vasoconstrictive state, and this may
adversely affect the test results. Or
The room temperature sensor shows
above 32 centigrade or 89.6
Fahrenheit which is not optimal for
this test. This flag is raised when the
difference betweenthe right finger
temperature and roomtemperature is
not sufficient. It indicates thatthe
finger
temperature
and
the
roomtemperature had a difference of
less than 3°C.This implies that the
right finger temperaturedoes not have
enough room to fall duringocclusion.
This situation could occur in the
casesof either a very high room
temperature or a low start finger
temperature.
In this condition, there is not enough
temperature
difference
between
fingertip and room. Not enough
temperature drop will be created to
make sure the test result is accurate.
Recommendation: maintain a stable
room temperature above 24°C or 75°F
and less than 32 °C or 89.6 °F at all
times.
Fluctuating RoomTemperature
Redflagindicates that the room
temperature varied more than1 °C
during the test. This ismostoften
caused
byair42
conditioningturningon.Whentriggered,
thisflag indicates that the ambient
(room)temperature
varied
byalargeextentduring thetest. Possible
reasons for
Fluctuatingroom temperature include:
cold or warm airfromanair vent began
circulatingover the testarea; the door
to the testroom was opened or closed
during
thetest,
etc.
Significantchangesinroom
temperature may sometimes cause a
subjectto enter a vasoconstrictive
state, causing both right andleftfinger
temperatures to steadily decline.
Vasomotor Instability
This will flag cases where the left
finger temperature rises too high due
to the vessel open during the whole
test.
43
Elaboration of VENDYS Report
1. Flip Data: Click here to flip the data of both hands. This button is pressed
normally when the probes are put on the wrong hands. After pressing this
button, the data collected by temperature probes will be swapped. In this case,
the patient doesn’t have to repeat the test.
2. PrintButton: To produce a hardcopyofthetestresultsonce the test is complete,
clickonthePrintable Versionbuttonand printtheformto a local printer.
Anycommentswill be printed asa secondpage.
3. Email: To emailtestresultsonce the test is complete, clickontheEmail button.
4. Warning Log: Click here to get the history of the warning pop-up windows
during the test.
5. Notes: Click buttonto opena newwindowto addcommentsaboutthe test if any.
Thecommentswillbe savedasa metadatain theimage once the home
buttonispressed. The commentscan be viewed at the CompletedTest
Viewerscreen.
44
6 . VENDYSReport: CompletedVENDYSreportdisplaysthefinal temperature
graph, the vascular reactivityindexanditsrepresentation, the blood pressure
and pulse details, theroomtemperature during thecourse of the test, the zero
reactivitycurve, the graph of the adjusted reactivity curve, anyflagsand
otherdetailsaboutthecompletedVENDYStest.
(See
the
VENDYSReportsection.)
7. Return: Click on this button to go back to the main page of the VENDYS
software.
1. Flip Data
After clicking on the “Flip Data”, the following pop-up window “Do you confirm
to flip data” will show up.
1. Yes: Click here to confirm to flipthe data
45
2. No: Click here to notswapthe data
2. Print
After clicking on the “Print” button, the following page will show up
3. Email:
After clicking on the “Email” button, the following page will show up
46
Please see the instruction XX part to learn more details about how to send
VENDYS testReport
4. Warning Log
After clicking on the “Warning Log” button, the following page will show up.The
warning pop-ups are saved in this page todescribe what happened during the test.
47
5. Notes
After clicking on the “Notes” button, the following page will show up
1. OK: Press this button to save the notes made here
48
2. Return: Click on this button to return to the test report without saving the
notes made here.
6.VENDYS®Report
Temperature Graph:
Displays temperature graph of VENDYS
test. Thelegend above indicates that the
right bold line isthe right hand, and the
blue bolded line is the left.The green line
indicates
the
zero
reactivity
curve,theexpected temperature increase if
there was novasodilation. The red
vertical lines separate thedifferent phases
of the test. The red horizontallines mark
the minimum temperature reached andthe
start temperature at the time of inflation.
Directly above the graph is the filename
that willappear in the list of studies in the
completed test viewer
Warning Flags:
Displays any warning flags that may
have beenraised in red. (Please refer
tothe“Descriptions
ofWarning
Flags”section.)
Adjusted Reactivity Curve:
This temperature graph displays the
adjustedcurve of the difference between
the zero reactivitycurve and the observed
temperature rebound inthe occluded arm.
The final report aTR is themaximum
value in this graph.
Vascular Reactivity Index:
Displays a
general
reading of
cardiovascular healthbased on the level
of the final aTR value: an aTRbelow 1 is
considered
to
show
poor
cardiovascularreactivity, whereas an aTR
of between 1 and 2 isconsidered
intermediate, and an aTR of more than2
is considered healthy.
49
Room Temperature Graph:
This graph displays the fluctuations in
roomtemperature during the testing
period. A flag maybe raised if the room
is cold or the roomtemperature
fluctuates.
(Please
refer
to
the“Descriptions
of
Warning
Flags”section.)Inaddition, if sympathetic
behavior is present, it maybe due to
fluctuating room temperatures. If
thisoccurs, it can be confirmed by
looking for similarbehavior in the room
temperature
graph.
Forinstance,
temperature decreases in the nonoccludedhand may be due to air
conditioningcycles and this would be
represented as atemperature decrease in
the room.
Blood Pressure and Pulse:
This graph displays the measurements
takenduring the blood pressure section. It
shows thesystolic, diastolic, and mean
pressure as well as themeasured pulse.
aTR Value:
The gauge indicator displays the final
aTR(adjusted temperature rebound)
value. The aTRvalue magnitude directly
correlates
with
the
extentofthesubject’svascularreactivity
NVRI Value
XXXXX
Name, Date and Time
Displays the name of the patient, date
and time that the test was takenat.
7. Return:
Whenfinishedwiththisscreen,clicking“Return”willreturntheusertotheMain
VENDYS test.
Page
of
50
VENDYS II Graphic User Interface
Login Page
1. Login: press the “green icon” in the middle of the screen, toinput
username and password, you will then enter into the system
successfully. If the icon indicates “Logout”, someone is already
logged in. Simply press the icon to log them out, then press again to
proceed.
2. Video Gallery: Several tutorial videos are included behind this button,
which will give a better understanding about thetest.
3. Tutorial: User guide and VENDYS II Web Page information will be
provided in this section
4. Contact Us: Click here to find the customer support contact and
company information.
5. Next Step: Use “Next Step”, only if you are already logged into the
system (green button indicates “Logout”).
Login
1. After clicking on the green “Login” button in the middle of the login page, it
will lead you to the following login page. There are three options for the
customer to choose.
a. Superadmin: this is for the Endothelix technical support
b. Admin: this is for the administrator of local clinic, the operators can be
added via this account
51
c. Operator (This option will show up after adding operators on the
following main page and is the normal choice after setup)
2. Choose the “admin” as the “User Name”. The default password for “Admin”
is “888888”.
 OK: After entering the password for “Admin”, click on “OK” button to go to
the operation “Main Page”.
 Change password: You can change your password by clicking on the “Change
Password” button right under the password column.
 Exit: After clicking on “Exit” button, the device will lead you back to the
previous login page.
52
Video Gallery
After clicking on the pink videogallerybutton shown on the screenshot picture above,
the following picture appears.
1. The title for this session.
53
2. Tutorial video list: These videos will give a detailed introduction to VENDYS
vascular function test and the principle behind it.
Tutorial
1. User Guide: 5 useful documents are included behind this link, which will give
a detailed introduction to the VENDYS test and:
 VENDYS Quick Guide
 Instruction Manual
 VENDYS Brochure for Physician
 VENDYS Flier for Patient
 Test Report Explained
2. VENDYS II Web Page: Most recent/updated information can be gained under
this button. You still can find more information via this link
www.endothelix.com/vendys-II
1. User Guide
54
1. Title
2. Tutorial PDFdocuments. These documents will give a detailed introduction to
VENDYS vascular function test method
 VENDYS Quick Guide
 Instruction Manual
 VENDYS Brochure for Physician
 VENDYS Flier for Patient
 Test Report Explained
VENDYS II Web Page
55
VENDYS II Web Page: Most recent/updated information can be gained under
this button. You still can find more information via this link
www.endothelix.com/vendys-II
Contact Us
56
Contact Us (The blue telephone icon): Click here to find out the customer support
contact and company information.
VENDYS II Main Page
1. “Touch here to start” button: After clicking on this button, several tutorial
instruction will be given to show you how to prepare for the test, and a few
basic and health questions will be asked before doing the VENDYS test.
2. “Add Operators” button: Operators information can be added via this link. The
difference between operator and admin is that, admin has the access to “Add
operator”and “Setting”. But operator doesn’t.
3. “Setting” button: The customer can personalize some changes while doing
their VENDYS test
4. Local file: User guide and VENDYS II Web Page information will be
provided in this section
5. Contact Us Button (The blue telephone icon): Click here to find out the
customer support contact and company information.
6. Video galleria: A brunch of tutorial videos are included behind this button,
which will give a better understanding about this test.
7. Patient folder: The tests results will be saved in this folder after tests are done.
Add Operators
After clicking on “Add Operator” button, the following page will show up.
57
1. The title for this page
2. Plus button: the admin can add operator information via clicking on plus
button.
3. Add Email Server: Adding additional email server can help add operator’s
email address under the “Add operator” session.
4. Trashcan button: After checking the box in front of the specific operator, and
then pressing on the “Trashcan” button, all the information concerning this
specific operator will be removed.
5. Return: The user will go back to the Main Page after clicking on the “Return”
button.
6. Plus Button: adding operator
Plus Button
After clicking on the “Plus” button, the following page will show up. The items
followed by the star mark are required for the operators
58
1. Operator Name: Entering the operator name in blank after “Operator Name”.
This is required item.
2. Telephone: This is optional
3. Email: This is required item, which will be used to send test report to the
patient
4. Email password: This is required item, which is necessary for the verification
of the email address entered above.
5. Address: This is optional.
6. Password: This password is used for the previous login page
7. Confirm Password: Please enter the exact same password as the one you enter
above
Add email server
After clicking on the “Add email server” button, the following page will show up. If
your commonly used email doesn’t fell into these categories, please click on the plus
button on the right top of the screen to add your email server.
59
1) Plus Button: the admin can add serverinformation via clicking on plus button.
2) Trashcan button: After checking the box in front of the specific email server,
and then pressing on the “Trashcan” button, the selected email server will be
removed.
3) Return: The user will go back to the “Add Operator” page after clicking on the
“Return” button.
1) Plus Button
After clicking on the “Plus” button on the right top of the screen, the following page
will show up, please enter the server name, for example: “XXXX”. And then click
60
on the “Save” button. The new server will be saved.
Settings
After clicking on the “Setting” on the Main Page, the following page will show up.
1. Patient Number: a unique sequence of numbers will be generated for each
patient. You can use unique numbers generated by the system automatically or
you can create your own unique numbers for the patients in your clinic
manually.
2. BP Unit: The unit for blood pressure, there are two options for that. One is
mmHg, the other is Kpa. Please choose the one you feel comfortable with.
3. Height Unit: The unit for height, there are two options for that. One is cm, the
other is inch. Please choose the one you feel comfortable with.
4. Weight Unit: The unit for weight, there are two options for that. One is kg, the
other is lb. Please choose the one you feel comfortable with.
5. Waist Unit: The unit for waist, there are two options for that. One is cm, the
other is inch. Please choose the one you feel comfortable with.
61
6. Medical information: enter the medical institution’s name, address, telephone,
email, and website. The medical institution’s name will show up at the
patient’s report, which suggests the patient gets tested in this clinic.
7. Volume: The volume of the device can be adjusted down by moving the little
grey bar from the right to left.
8. Audio-Prompts: the audio can be adjusted to the highest if the “On” button is
pressed. While the audio will be totally turned off once “Off” button is pressed.
9. Setting: Other settings like Ethernet, WIFI, Bluetooth, Date&Time, Display
&Volume, and Printer.
10. Database Report: All the patient tests data can be exported via this link.
11. Export Log: All the warnings during the test will be saved in this log for
remote troubleshooting
12. Update: The current program can be updated via clicking on this button
13. Save: Any change is made, this button has to be clicked on to save the changes
user makes.
14. Default: If user wants to set everything in the setting section as the factory
setting, please click on default button.
15. Return: After clicking on this button, the system will lead you back to the
Main Page.
16. Software version: The version number is followed by the software version.
9. Setting
After clicking on the “Setting”, the following page will show up.
62
1)
2)
3)
4)
5)
Ethernet: Ethernet can be set up via clicking on this button.
WiFi: WiFi Setting.
Bluetooth: The device can be connected to the Bluetooth device via this button.
Date &Time: The Date and Time can be set up via this button.
Display & Volume: The brightness of the screen and volume can be changed
here.
6) Printer: The printer setup.
1) Ethernet
After clicking on the “Ethernet”, the following page will show up.
1. Switch the button on the right side of the Ethernet button to turn on/off the
ethernet
2) WIFI
After clicking on the “WIFI”, the following page will show up.
63
1. Switch the button on the right side of the WIFI button to turn on/off the WIFI
3) Bluetooth
After clicking on the “Bluetooth”, the following page will show up.
1. Switch the button on the right side of the Bluetooth button to turn on/off the
Bluetooth
64
4) Date & Time
The Date and Time can be set up via this button. After clicking on this button, the
following page will show up
1. Date Setup. Click on the date on the right side of the date setup, a calendar
will show up automatically, you can choose the date you want to set.
2. Time Setup: The time can be set up here via changing the time
3. Time zone setup: The time zone can be set up by choosing the one matching
yours
5) Display & Volume:
The Display & Volumecan be set up via this button. After clicking on this button, the
following page will show up
6) Printer
After clicking on this button, the following page will show up
65
1. Clicking on “Search equipment” to search the printers within your area, and
click on the one you want to connect. And then printer is set up successfully.
After getting it done successfully, the patient report can be printed out via this
printer.
10. Database Report:
After clicking on this button, the following page will show up
66
1) Generate: After clicking on the “Generate” button, all the patient test results
will be compressed in one zip package. A message will appear after the
compression process is done
2) Email: after clicking on “Email” button, the zip file can be sent out via email
3) Return: After clicking on this button, it will take you to the setting Main page.
2) Email
After clicking on “Email”, the following page will show up.
67
1.
2.
3.
4.
5.
Receiver: this is the one who you want to send report to
CC: You can copy anyone who you want to include in this email
Sender: This is email address for Endothelix company
Subject: The default subject for this email is “VENDYS Test Report”. You
can change this subject based on your need.
The content of the email: The default of the content is “Hello, Please see the
report of your VENDYS vascular function test attached. Thank you”. You can
change this subject based on your need.
Tutorial
Please find the detailed information on instruction for the login page
Contact Us
Please find the detailed information on instruction for the login page
Video Gallery
Please find the detailed information on instruction for the login page
Patient Records:
After clicking on the pale pinkish purple icon on the main page, the following page
will show up.
68
1. Saved Patient’s Information: Click on the patient information to get the
patient history
2. VRI Trend: This feature will show the trend for vascular function test results
for a specific patient
3. Trash button: Click on the square box in front of the plus button and press on
trash button, the corresponding patient record will be removed.
69
4. Data Quality Summary: This feature will show the summary for all the flags a
specific patient suffered during the tests
5. Search: The search button will ensure you get all the information for a specific
patient. You can search by Patient ID/Patient Name
6. Main page: Click here to lead you to the main page of the test.
7. Plus button: Click here to expand to get more information of the patient. Click
on the row next to the square checking box, the patient information and health
information will show up. The existing patient information can be edited here.
Please find the screenshot below.
8. Open report: Click here to get the report for a patient on specific date
Saved Patient’s Information
After clicking on one of the patient history, the following page will show up.
1) Save: Click here to save the changed patient information
2) Cancel: Click here to cancel the changes made here
3) Health Info: Click here to get the health information of the patient
3) Health Info
After clicking on the “Health Info”, the following page will show up.
70
1. Cancel: Click here to cancel the changes made here
2. Save: Click here to save the changes made here
Open Report
After clicking on the “Open Report” button, the following page will show up.
71
1. Flip Data: To flip the data of right and left hands, to reverse the temperature
got from both hands.
2. Email: Click here to email the test report
3. Notes: Click here to add notes on this report
4. Warning log: Click here to get the warning log happened during the test
5. Print: Click here to print the test results
6. Return: Click here to return to the patient record page.
VRI Trend
After tapping on “VRI Trend”, the following page will show up
1)
2)
3)
4)
Start Time: click here to enter the searching start time.
End Time: Click here to enter the searching end time.
OK: Click here to start searching.
Return: Click here to return to the patient record page.
After clicking on “OK”, the following page will show up
72
1. Email: Click here to email the VRI trend report
2. Print: Click here to print the VRI trend report
3. Return: Click here to return to the patient record page
Data Quality Summary
After clicking on the “Data Quality Summary” button, the following page will show
up.
73
1)
2)
3)
4)
Start Time: click here to enter the searching start time.
End Time: Click here to enter the searching end time.
OK: Click here to start searching.
Return: Click here to return to the patient record page.
After clicking on “OK”, the following page will show up
1. Email: Click here to email the Data Quality Summary
2. Print: Click here to print the Test report Summary
3. Return: Click here to return to the patient record page
74
Troubleshooting
Cannot get info from Probes
1. Plug the probes back to the HDMI port on the left side of the device
2. If the problem was not get solved, please contact Endothelix support
to change a new probe
Low Battery
Connect the device to the power outlet on the wall to maintain thedevice
work very well.
Battery problem
1. Battery cannot be charged to full performanceand please contact
Endothelix support forthereplacement.
2. Thebattery cannot store theelectricity and please contact Endothelix
support forthereplacement.
3. The battery doesn’t work after unplug the power outlet, please
disconnect and connect the battery cable one more time.If the problem
didn’t not get solved, please contact Endothelix support for further
information
Failed to get information from SD card
Take the SD card out and re-plug into the card slot.
Cannot turn on the machine
Circuit board problem andpleasecontact Endothelix support for further
information
The monitor cannot display very well after turning on the machine
LCD problem and please contact Endothelix support for further information
The screen is stuck on the booting video page
Circuit board problem and please contact Endothelix support for further
information
Keypad is not coming out while typing
Circuit board problem and please contact Endothelix support for further
information
VENDYS keeps rebooting after turning on
Circuit board problem and please contact Endothelix support for further
information
75
Touch screen is not working
One of cables got loosed andplease contact Endothelix support for
replacement
Blood pressure cuff cannot be inflated
Circuit board problem and please contact Endothelix support for further
information
Cuff leakage problem
Disconnect and reconnect the BP hose. If the problemstill persists, please
contact Endothelix support for replacement
Inappropriate placement of BP Cuff (other cuff problems)
Please make sure the cuff was placed on patient arm appropriately,
neither too tight nor too loose.
76
Technical Information:
Temperature Probes (RTD) Specification
Parameter
Specification
Sensor Type
1000 Ohm RTD Temperature Sensor
Sensor Curve Type
TC=3850 ppm/K
Sensor Self-Heating
0.4K/mW at 0 C
Sensor Accuracy
+/- 0.15 C minimum including cable
and connector
Range
10 to 45 C(50 to 113 F)
Resolution
0.01 C (0.018 F)
Accuracy
+/- 0.1 C (0.18 F)
Host Sampling Rate
1 Hz to 40Hz in integer value
increments
Wire Type
24-28 AWG twisted pairs with
overall shield
Max Sensor Cable Length
6 Feet
VENDYS II Machine Specification
Parameter
Specification
Description
Min Inflated Pressure
10 mmHg
Minimum pressure to
which a cuff can be
inflated and held
Max Inflated Pressure
270 mmHg
Maximum pressure to
which a cuff can be
inflated and held
Pressure Resolution
1 mmHg
Pressure reported to
host will be to nearest 1
77
mmHg
Pressure Accuracy
+/- 5 mmHg
Pulse Rate Range
40 - 240 BPM
Pulse Rate Resolution
1BMP
Cuff Regulation
+/- 10 mmHg
Cuff pressure will be
maintained to specified
pressure
with
this
tolerance
Min Pumping Rate
6 LPM
Minimum
rate
of
pumping air into cuff at
no load
Power Input Voltage
24 V.D.C.+/- 5%
Regulated 24 VDC
power supply voltage
Max
Power
Voltage Ripple
Max
Duration
Input 100mv pk-pk
Occlusion 20 minutes
Battery voltage
Absolute accuracy of
pressure measurement
D.C. 14.8V
The maximum duration
that either of the cuffs
can be inflated
The built-in
lithium battery
battery
Product Labels
78
Packing List for VENDYS System
NO.
Name
Number
VENDYS-II
Machine
1PCS
Temperature 1PCS
Probes
and
Adhesive Clips 1PCS
Cuff Tube
1PCS
ProductchartFunctiondescription
Note
Measures and displays vascular functionImportantaccessories
using digital thermal monitoring of
Fingertip and room temperature sensors
Attaches
to
fingertips
Importantaccessories
foraccurate Importantaccessorie
ConnectsBPcufftoVENDYS-II Machine Importantaccessories
Blood Pressure1PCS
Cuff
Measuresbloodpressure
Importantaccessories
Infrared
Thermomet
Instant
measure
of
fingertip
temperature to detect cold fingers
Importantaccessories
Laptop
pad
Electric Heating1PCS
Blanket
To warm subjects and alleviate coldImportantaccessories
fingers
PowerAdapter 1PCS
Powersupplyfor VENDYS-II machine
Importantaccessories
10
PowerCord
1PCS
Connects powersupplytothemachine
Importantaccessories
11
Instruction
Manual
1PCS
Detailed
instructions
VENDYS-II System
12
Quick Guide
1PCS
Quick illustrative guide
VENDYS-II System
13
Certificate
1PCS
Quality controlcertificates
Importantaccessories
14
WarrantyCard 1PCS
Productwarrantycertificate
Importantaccessories
15
PackingList
Packinglist
Importantaccessories
1PCS
handsPCS
1PCS
Rests hands
temperature
and
isolates
to
to
fingertipImportantaccessories
operateImportantaccessories
operateImportantaccessories
79
Appendix A: License Agreement and Limited Warranty
User Hardware/Software/Product License from Endothelix
IMPORTANT – PLEASE READ THIS LICENSE AGREEMENT CAREFULLY BEFORE
INSTALLING OR OTHERWISE USING THE LICENSED HARDWARE AND
SOFTWARE (AS DEFINED BELOW) OR THE PRODUCT WITH WHICH YOU
RECEIVED THIS LICENSE AGREEMENT. THIS LICENSE AGREEMENT APPLIES
TO:
a) ALL LICENSED HARDWARE AND ITS USE AS PROGRAMMED BY
ENDOTHELIX ONLY AND MEDICAL AND PHYSICAL DATA ACCUMULATED
FROM COMBINED HARDWARE, SOFTWARE AND PRODUCT USE UNDER THE
PRODUCT AS PROVIDED;
b) ALL LICENSED SOFTWARE AND ITS USE AS PROGRAMMED BY ENDOTHELIX
ONLY AND MEDICAL AND PHYSICAL DATA ACCUMULATED FROM COMBINED
HARDWARE, SOFTWARE AND PRODUCT USE UNDER THE PRODUCT AS
PROVIDED:
c) ALL LICENSED PRODUCTS (AS DEFINED BELOW), and
d) ALL THIRD PARTY PRODUCTS (AS DEFINED BELOW).
SHOULD YOU HAVE ANY QUESTIONS CONCERNING THIS LICENSE
AGREEMENT, OR PERMITTED USE OF THE HARDWARE, SOFTWARE, OR
PRODUCT(S) PROVIDED THROUGH THIS AGREEMENT, PLEASE CONTACT THE
VENDOR FROM WHICH YOU PURCHASED THE LICENSED HARDWARE,
LICENSED SOFTWARE, LICENSED PRODUCT OR THIRD PARTY PRODUCT. YOU
MAY ALSO CONTACT ENDOTHLIX AT THE ADDRESS PROVIDED AT THE END
OF THIS LICENSE AGREEMENT.
This License Agreement is a legal instrument between you (as an individual, company,
organization, or other entity) and Endothelix Inc. (“Endothelix”). By installing, copying, or
otherwise using this Licensed Product, Licensed Hardware or Licensed Software or any Third
Party Product, you agree to be bound by the terms of this License Agreement with respect to the
Licensed Hardware, Licensed Software and Licensed Products. If you do not agree to the terms of
this License Agreement, INCLUDING, WITHOUT LIMITATION, THE LIMITATIONS ON
USE AS PROVIDED IN SECTION 2.4 AND THE RESTRICTIONS ON USE AS PROVIDED
IN SECTION 2.5, do not install, use or copy the Licensed Hardware, Licensed Software or
Licensed Product or the Third Party Product.
For avoidance of doubt, in the event that you have entered into an agreement in writing
(“Subsequent Agreement”) with Endothelix covering the subject matter of this License, then to
the extent any such terms or provisions of such Subsequent Agreement are in conflict with,
different than, or in addition to, the terms and provisions of this license, such terms and
provisions of such Subsequent Agreement shall prevail.
The Licensed Software and the Licensed Products are protected by US patent laws, trade secret
laws, copyright laws, and international treaty provisions as well as other intellectual property
laws and treaties. Therefore, you must treat the Licensed Hardware, Licensed Software and
Licensed Products like any other copyrighted and protected material or product. Therefore, you
must treat the Licensed Hardware, Licensed Software and all intellectual property rights in and to
the Licensed Hardware or Licensed Software and the Licensed Products shall remain with
Endothelix.
1. Definitions
1.1 “Licensed Product(s) “ means the VENDYS®, the test probes (whether provided with the
80
product directly by sale, resale, lease, or other placement method, directly or indirectly),
and the corresponding component of Endothelix or any Third Party Product with which
this Licensed Agreement was received. The Licensed Product(s) is (are) a stand-alone
product and some Third Party Products are incorporated for component use in the
Licensed Products, as such may be in each case sold, leased, or otherwise made available by
Endothelix and/or third parties. If you have received this License Agreement with a Third
Party Product, this License Agreement applies only to the Licensed Product incorporated
use as a component within the Licensed Product or a Third Party Product.
1.2 “Licensed Software” means the EndothelixVENDYS® _software, and the associated
media and accompanying materials provided to you with such EndothelixVENDYS®software.
The Licensed Software is a stand-alone software program used only with the Licensed
Hardware and Licensed Product to provide resulting data information from the overall
combined use and operation of the Licensed Software, Licensed Hardware, and Licensed
Product, as in each case sold, leased or otherwise made available, by Endothelix and/or
third parties. If you have received this License Agreement with a Licensed Product, which
incorporates the software as a component within such Licensed Product, this License
Agreement applies to the Licensed Software.
1.3 “Licensed Hardware” means the EndothelixVENDYS®software, and the associated
media
and
accompanying
materials
provided
to
you
with
such
EndothelixVENDYS®_software. The Licensed Software is a stand-alone software program
used only with the Licensed Hardware to provide resulting data information from the
overall combined use and operation of the Licensed Software, Licensed Hardware, and
Licensed Product, as in each case sold, leased or otherwise made available, by Endothelix
and/or third parties. If you have received this License Agreement with a Licensed Product,
which incorporates the software as a component within such Licensed Product, this License
Agreement applies to the Licensed Software.
1.4 “Third Party Product” means any product which a Licensed Product or into which any
of the Licensed Product, Licensed Software, or Licensed Hardware is incorporated.
2. LICENSE TO USE, LIMITATIONS AND RESTRICTIONS ON USE
2.1 LICENSE TO USE LICENSED SOFTWARE. Endothelix hereby grants you a non-exclusive
right to use the Licensed Software (i) solely with the Licensed Product(s), and (ii) solely for its
intended use in testing of endothelial function in accordance with the provisions of this License
Agreement and the instructions provided in the documentation accompanying the Licensed
Hardware, Licensed Software and the Licensed Product, subject to the Limitations on Use as
provided in Section 2.5. You may only download the data provided for download by the hardware
and software program functions as provided by Endothelix for pre-programmed use of the
Licensed Product(s). However, you may not cause any Licensed Software, which is not designed
or specifically authorized by Endothelix for use as part of the Product, to execute or be loaded
into the active memory or media of any other computer apart from the computer programmed
system provided on the Licensed Product only.
2.2 LICENSE TO USE LICENSED HARDWARE. Endothelix hereby grants you a nonexclusive right to use the Licensed Hardware (i) solely with the Licensed Product(s), and (ii)
solely for its intended use in testing of endothelial function in accordance with the provisions of
this License Agreement and the instructions provided in the documentation accompanying the
Licensed Hardware, Licensed Software and the Licensed Product, subject to the Limitations on
Use as provided in Section 2.5. You may not make any copy of the Licensed Hardware for any
purpose, and you may not transfer the Licensed Hardware to any single hard disk for any
purposes.
2.3. LICENSE TO USE LICENSED PRODUCTS. Endothelix hereby grants you an non-
81
exclusive right to use the Licensed product(s) (i) solely with the Licensed Software and Licensed
Hardware provided as component parts of the Licensed Product, and (ii) solely for its intended
use in testing endothelial function in accordance with the provisions of this License Agreement
and the instructions provided in the documentation accompanying the Licensed Software,
Licensed Hardware and Licensed Product, subject to the limitations on Use in Section 2.3 and the
Restrictions on Use as provided in Section 2.5.
2.4. LIMITATIONS ON USE. The licenses granted in Sections 2.1, 2.2 and 2.3 above are for use
in normal medical practice, and you are not licensed or authorized to include, or use in any
manner, or to provide to any third party for such inclusion or use, any test results derived from the
VENDYS® _and/or the Licensed Software and/or Licensed Hardware for the purpose of obtaining
any regulatory approval from any governmental or regulatory agency of any diagnostic or
therapeutic claim, or medical device, pharmaceutical or other therapeutic or diagnostic product.
Without derogating from the generality of the foregoing, the inclusion by you of any third party
of any results of any type, derived through the use of the VENDYS® _and/or the accompanying
Licensed Software and Licensed Hardware, in any regulatory filing for the purpose of supporting,
or obtaining such approval, without the prior written consent of Endothelix is expressly
prohibited. THIS LIMITATION REFERES SOLELY TO THE SEEKING OR OBTAINING OF
DIAGNOSTIC OR THERAPEUTIC CLAIMS AND NOTHING IN THIS AGREEMENT,
INCLUDING THS LIMITATION ON USE, IS INTENDED, IN ANY MANNER, TO
RESTRICT THE REPORTING OF INFORMATION REGARDING THE VENDYS® IN
ACCORDANCE THE REPORTING REGULATIONS OF ANY GOVERNMENTAL OR
REGULATORY AGENCY.
Notwithstanding the foregoing limitations on use, you are granted permission to use the data and
compilations obtained from your use of the Licensed Product for the following limited purposes,
under the further strict limitation in such use, of your compliance with all patient privacy rights as
provided under governmental law or regulation for patient privacy and for use and compilation of
medical information and research group data from individual patient applications and data
collection, including:
a) You are permitted to use data information compiled and provided you under the programmed
use of in the Licensed Product for educational, scientific, or research purposes, including data
compiled and extracted from use of the Licensed Product, for the purpose of illustration,
explanation, example, comment, criticism, teaching, research, or analysis;
b) You are permitted to use data information compiled and provided you under the programmed
use of in the Licensed Product in the preparation of Course Packs or other educational materials;
c) You are permitted to use data information compiled and provided you under the programmed
use of in the Licensed Product for use in connection with specific courses of instruction offered
by you for medical education purposes; and
d) You may transmit to a third party in hard copy or electronically, minimal, insubstantial
amounts of collected data compiled and provided you under the programmed use of in the
Licensed Product for scholarly, educational, or scientific research or professional use, but in no
case for resale or commercial purposes.
2.5. RESTRICTIONS ON USE. Any use of the Licensed Software, Licensed Hardware and/or
Licensed Product other than as set forth in Sections 2.1, 2.2, and 2.3 above, in each case as
limited by Section 2.4 above, is strictly forbidden. Without derogating from the generality of the
above you may not:
a) distribute, reproduce, copy, assign, rent, lease, or otherwise transfer the rights granted to you
under this License Agreement to any third party except as explicitly set forth in this License
Agreement;
b) reverse engineer, decompile, or disassemble, as applicable the Licensed Software, Licensed
82
Hardware, or Licensed Product, except as expressly permitted by applicable law; or
c) modify in any manner the Licensed Software and/or the Licensed Product unless obtaining the
prior written consent of Endothelix.
3. TRADEMARKS
Endothelix, VENDYS® _and all trademarks and logos, which appear on or in connection with the
Licensed Software, Licensed Hardware and/or Licensed Products, as may be amended from time
to time, are, unless stated otherwise, trademarks of Endothelix. No right, license, or interest to
such trademarks are generated or granted hereunder other than the limited right to use provided
herein, and you agree that no such right, license, or interest shall be asserted by you with respect
to such trademarks. You may not remove or destroy any copyright, logo or other proprietary
marking or legend placed on or contained in the Licensed Software, Licensed Hardware or a
Licensed Product.
4. LIMITED WARRANTIES AND DISCLAIMERS
4.1. AGAINST INFRINGEMENT. Endothelix hereby warrants to you that it has the right to
grant you the license to use the Licensed Software, Licensed Hardware and/or Licensed Product
and to enter into this License Agreement and that neither the Licensed Software, the Licensed
Hardware nor the Licensed Product(s) infringes the intellectual property rights of any third party.
4.2. AS TO LICENSED PRODUCT. Endothelix warrants to you that the Licensed Product, with
which this Licensed Agreement was delivered, will be free from defects in design, materials, and
workmanship for a period of one year from the date of delivery of the Licensed Product to you. If
the Licensed product contains a defect in design, materials or workmanship and such Licensed
Product is returned to Endothelix within one (1) year of delivery of the Licensed Product to you,
Endothelix will repair or replace the Licensed product, or issue a credit for the purchase price of
the Licensed product, with the choice to repair, replace, or credit being within the sole discretion
of Endothelix. The foregoing repair, replacement, or credit remedy will be your sole remedy for
breach of the warranty set forth in this Section 4.2.
4.3. AS TO LICENSED SOFTWARE. Endothelix warrants that for a period of ninety (90) days
from the date of delivery of the Licensed Software to you, the Licensed Software will, under
normal use, be free from defects in materials and workmanship, and will perform substantially as
it is intended to perform. If during such ninety (90) days, the Licensed Software has a defect in
materials or workmanship or does not perform substantially as it is intended to perform,
Endothelix will (a) attempt to correct or assist you around errors with efforts which Endothelix
believes suitable to the problem, (b) replace the Licensed Software with a functionally equivalent
software, or (c) issue a credit for the purchase price of the Licensed Software, with the choice to
correct or assist, replacement or credit being within the sole discretion of Endothelix. The
foregoing correct or assist, replacement or credit remedy will be your sole remedy for breach of
the warranty set forth in this Section 4.3.
4.4. AS TO LICENSED HARDWARE. Endothelix warrants that for a period of ninety (90) days
from the date of delivery of the Licensed Hardware to you, the Licensed Hardware will, under
normal use, be free from defects in materials and workmanship, and will perform substantially as
it is intended to perform. If during such ninety (90) days, the Licensed Hardware has a defect in
materials or workmanship or does not perform substantially as it is intended to perform,
Endothelix will (a) attempt to correct or assist you around errors with efforts which Endothelix
believes suitable to the problem, (b) replace the Licensed Hardware with a functionally equivalent
software, or (c) issue a credit for the purchase price of the Licensed Hardware, with the choice to
correct or assist, replacement or credit being within the sole discretion of Endothelix. The
foregoing correct or assist, replacement or credit remedy will be your sole remedy for breach of
the warranty set forth in this Section 4.4.
83
4.5. LIMITATION OF WARRANTIES. The warranties contained in Sections 4.2, 4.3, and 4.4
above do not cover damage to the Licensed Products, Licensed Software or Licensed Hardware
caused by accident, misuse, abuse, negligence, failure to install in accordance with Endothelix’s
installation instructions, failure to operate under conditions of normal use and in accordance with
the terms of the documentation accompanying the Licensed Product, Licensed Software, and/or
Licensed Hardware, failure to maintain in accordance with the applicable documentation
accompanying the Licensed Product, Licensed Software, and/or Licensed Hardware, alteration or
any defects not related to materials or workmanship, or in the case of Third Party Licensed
Products, design, materials or workmanship. This warranty does not cover damage which may
occur in shipment. This warranty does not apply to Licensed Products, Licensed Software, or
Licensed Hardware not purchased new. This warranty does not apply to any Licensed Product or
any individual parts of a Licensed product which have been repaired or altered by anyone other
than Endothelix or a person or entity authorized by Endothelix to repair Licensed products.
While every reasonable effort has been made to ensure that you will receive Licensed Software,
Licensed Hardware, and/or Licensed Product that you can use, Endothelix does not warrant that
the function of the Licensed Product, Licensed Software, and/or Licensed Hardware will meet
your requirements or that the operation of the Licensed Product, Licensed Software, and/or
Licensed Hardware will be uninterrupted or error free. Endothelix is not responsible for problems
caused by your use of the Licensed Software with non-Endothelix software or non-Endothelix
hardware.
ENDOTHELIX HEREBY DISCLAIMS, WITH RESPECT TO THE LICENSED
SOFTWARE, LICENSED HARDWARE AND THE LICENSED PRODUCTS, ALL
OTHER WARRANTIES AND CONDITIONS, WHETHER EXPRESS OR IMPLIED,
INCLUDING, BUT NOT LIMITED TO MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE, ACCURACY OR COMPLETENESS OF INFORMATION,
LACK OF NEGLIGENCE AND CORRESPONDENCE TO DESCRIPTION.
5. LIMITATION OF LIABILITY
(A) TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, EXCEPT
FOR DAMAGES ARISING UNDER SECTION 4.1 ABOVE, IN NO EVENT SHALL
ENDOTHELIX BE LIABLE TO YOU FOR DAMAGES IN EXCESS OF THE
PURCHASE PRICE YOU PAID FOR THE LICENSED PRODUCT, LICENSED
SOFTWARE, AND/OR LICENSED HARDWARE, OR THE APPLICABLE THIRD
PARTY PRODUCT. THE FOREGOING LIMITATION SHALL BE APPLICABLE
REGARDLESS OF WHETHER THE ACTION GIVING RISE TO SUCH DAMAGES IS I
TORT, CONTRACT, STRICT PRODUCTS LIABILITY, OR OTHERWISE.
(B) IN NO EVENT SHALL ENDOTHELIX BE LIABLE FOR ANY SPECIAL,
INCIDENTAL, INDIRECT OR CONSEQUENTIAL DAMAGES WHATSOEVER
ARISING OUT OF OR IN ANY WAY RELATED TO THE USE OF OR INABILITY TO
USE THE LICENSED SOFTWARE, LICENSED HARDWARE, LICENSED PRODUCT,
OR THIRD PARTY PRODCT, OR THE PROVISION OR FAILURE TO PROVIDE
SUPPORT SERVICES BY ENDOTHELIX, EVEN IF ENDOTHELIX HAS BEEN
ADVISED OF THE POSSIBILITY OF SUCH CONSEQUENTIAL DAMAGES. THE
FOREGOING DISCLAIMER OF CONSEQUENTIAL DAMAGES SHALL BE
APPLICABLE REGARDLESS OF WHETHER THE ACTION GIVING RISE TO SUCH
DAMAGES IS IN TORT, CONTRACT, STRICT PRODUCT LIABILITY, OR
OTHERWISE.
(C) IN ORDER TO BE ENTITLED TO INDEMNIFICATION HEREUNDER IN
CONNECTION WITH AN INFRINGEMENT CLAIM, YOU MUST (i) NOTIFY
ENDOTHELIX IN WRITING PROMPTLY UPON BECOMING AWARE OF AN
84
INFRINGEMENT CLAIM OR THE POSSIBILITY THEREOF, (ii) GRANT
ENDOTHELIX SOLE CONTROL OF THE SETTLEMENT, COMPROMISE,
NEGOTIATION AND DEFENSE OF ANY SUCH ACTION, AND (iii) PROVIDE
ENDOTHELIX WITH ALL INFORMATION RELATED TO THE ACTION THAT IS
REASONABLY REQUESTED BY ENDOTHELIX. NOTWITHSTANDING THE
FOREGOING, ENDOTHELIX SHALL HAVE NO INDEMNIFICATION OBLIGATIONS
WITH RESPECT TO ANY INFRINGEMENT CLAIM TO THE EXTENT ARISIG
FROM YOUR USE OF THE LICENSED SOFTWARE, LICENSED HARDWARE,
LICENSED PRODUCT OR LICENSED THRID PARTY PRODUCT WHERE USE WITH
SUCH OTHER HAREDWARE OR SOFTWARE GAVE RISE TO THE
INFRINGEMENT CLAIM.
6. TERMINATION
Without prejudice to any other rights or remedies, Endothelix may terminate this License
Agreement immediately if you fail to comply with any of its terms and conditions. In the event of
such termination, you must, within ten (10) business days of receiving notice of termination from
Endothelix, cease all use of the Licensed Software and Licensed Hardware and destroy all copies
thereof, and cease all use of the Licensed Product (including Licensed Product incorporated
within Third Party Product).
7. TRANSFERABILITY
You may only transfer or assign the rights and obligations hereunder with the Licensed Software,
Licensed Hardware and/or the Licensed Product or Third Party Product as a whole, without
retaining any rights or, subject to Sections 2 and 3 above, any obligations arising after the date of
such transfer or assignment, or retaining any installed or uninstalled copy of the Licensed
hardware, Licensed Software, the Product or the Third Party Product. Any attempt by you to rent,
lease, sublicense, assign or transfer any of the rights, duties or obligations hereunder in any other
way is forbidden and shall be null and void.
8. SEVERABILITY
Should any term or provision of this License Agreement be declared void or unenforceable by
any court of competent jurisdiction in any country or countries, such declaration shall have no
effect on the remainder of this License Agreement in such country or countries, or on this License
Agreement in other countries.
9. NO WAIVER
The failure of either party to enforce any rights granted to it hereunder or to take action against
the other party in the event of any breach hereunder shall not be deemed a waiver by that party as
to subsequent enforcement actions in the event of future breaches.
10. GOVERNING LAW AND JURISDICTION
This License Agreement is governed by the laws of the State of Texas, excluding its conflict of
laws principles. The United Nations Convention on Contracts for the International Sale of Goods
shall not apply to any of the transactions contemplated by this License Agreement.
11. ENTIRE UNDERSTANDING
This License Agreement represents the complete and exclusive understanding between you and
Endothelix concerning the license by Endothelix to you of Licensed Software, Licensed
Hardware, and Licensed Products and supersedes all prior agreements and representations
between the parties with respect to the subject matter hereof, unless specifically stated otherwise
in a writing signed by Endothelix and you. The License Agreement may not be amended other
than by a written agreement specifically intended for this purpose and signed by Endothelix and
you.
85
FCC Statement
This device complies with part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) This device may not cause harmful interference, and (2) this device must accept
any interference received, including interference that may cause undesired operation.
Any Changes or modifications not expressly approved by the party responsible for compliance
could void the user's authority to operate the equipment.
Note: This equipment has been tested and found to comply with the limits for a Class B digital
device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable
protection against harmful interference in a residential installation. This equipment generates uses
and can radiate radio frequency energy and, if not installed and used in accordance with the
instructions, may cause harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation. If this equipment does cause
harmful interference to radio or television reception, which can be determined by turning the
equipment off and on, the user is encouraged to try to correct the interference by one or more of
the following measures:
-Reorient or relocate the receiving antenna.
-Increase the separation between the equipment and receiver.
-Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
-Consult the dealer or an experienced radio/TV technician for help.
FCC RF Exposure Information and Statement
The devices has been tested and meets applicable limits for Radio Frequency (RF)
exposure.
When carrying the product or using it a distance of 20 cm from the body to ensure
compliance with RF exposure requirements. Use of other accessories may not
ensure compliance with FCC RF exposure guidelines.
Contact Address: Should you have any questions concerning this License Agreement, or if you
desire to contact Endothelix for any reason, please write to:
Endothelix Inc.
710 N Post Oak Rd, Ste 204
Houston, Texas 70024
86

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Belter Health Measurement and Analysis Technology JK1V VENDYS II User Manual

Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. VENDYS II

Contents

User manual

FCC ID Filing: 2AAEEJK1V

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