VENDYS II Operation Manual- VENDYS Portable 1
Table of Contents VENDYS® Support.......................................................................................................................................4 Technical Information..............................................................................................................................5 Operating the Device ................................................................................................................................5 Cleaning .................................
Video Gallery ..................................................................................................................................................................... 68 Patient Records: ............................................................................................................................................................... 68 Troubleshooting ....................................................................................................................................
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.
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.
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 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.
Figure 1-1 Front view Number Function 1 Power switch button 2 Volume increase button 3 Volume decrease button 4 Statusindicator (Blue indicates the device is on. No light indicates the device is turned off).
7 Device label 8 Return button 9 Servicebutton (no effect in normal operation) 10 Emergency shut-off button 11 Microphone 12 Camera 13 LCDscreen 9
Figure 1-1 Right-side view Number Function 1 USB port 2 HDMI port 3 Micro-USBport 4 SD card slot 5 Null 6 Ethernet cable port 7 DC power input port 10
Figure 1-3 Rear-view Number Function 1 Handle 2 Built-in storage latch 3 Back coverplate 4 Nameplate 11
Figure 1-4 Left-side view Number Function 1 Probe HDMI connection 2 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.
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.
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.
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.
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.
4.
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”.
3. Click on “Add Operator” orange button on the left top of the screen, the following page will show up.
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.
Set up the Name of the Clinic 3.
2 3 4 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.
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.
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.
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.
“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.
“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.
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.
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”.
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.
4. Notes: Include other medical or basic information which is not included in the list above.
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.
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.
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
2. No: Click here to notswapthe data 2. Print After clicking on the “Print” button, the following page will show up 3.
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.
5. Notes After clicking on the “Notes” button, the following page will show up 1.
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.
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.
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.
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.
Video Gallery After clicking on the pink videogallerybutton shown on the screenshot picture above, the following picture appears. 1. The title for this session.
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.
1. Title 2. Tutorial PDFdocuments.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Packing List for VENDYS System NO.
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.
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.
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.
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.
4.5. LIMITATION OF WARRANTIES. The warranties contained in Sections 4.2, 4.3, and 4.
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.
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.
