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Table of Contents
Summary of Contents for Cnoga TensorTip VSM
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Page 1: User Manual
TensorTip™ VSM Vital Signs Monitor User Manual Page 1 of 72... - Page 2 COPYRIGHT 2010 CNOGA MEDICAL LTD. ALL RIGHTS RESERVED WORLDWIDE THIS MANUAL IS PROPRIETARY TO CNOGA Medical LTD. UNAUTHORIZED USE, DISCLOSURE OR REPRODUCTION IS PROHIBITED CNOGA Medical LTD RESERVES THE RIGHT TO MAKE CHANGES WITHOUT NOTICE TO THIS MANUAL AND THE PRODUCTS DESCRIBED HEREIN. Contact Cnoga Medical Ltd at: E-mail: info@cnoga.com...
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Page 3: Table Of Contents
Table of Contents Introduction ............... 7 What is the TensorTip ..............7 Warnings, Cautions and Notes ............ 9 Safety Notes ..................10 Indications for Use ................12 Important Notice ................12 Inside the Box ................14 TensorTip Components ..............15 Device Care ..................16 Page 3 of 72... - Page 4 Using the VSM ..............17 Turning the Device On and Off ............17 Icons .....................18 USB power supply& battery replacement ........21 First-time Operation..............24 Language selection ...............25 Performing a Measurement ............26 Measurement procedure ..............29 Interpreting your Graphs ...............36 The Valsalva maneuver ..............41 Switching Between Display Modes ..........43 Saving Measurement Results in History ........44 Page 4 of 72...
- Page 5 Viewing History ................44 Viewing Last Results ..............45 Viewing Results over PC ..............46 Adjusting Display Brightness ............47 Adjusting Blood Pressure Sensitivity ...........48 Adjusting TensorTip Perfusion .............49 Setting Date and Time ..............50 Product Self-Test ................52 Viewing Product Information ............56 Restoring Factory Defaults ............57 SW Reset ..................58 Page 5 of 72...
- Page 6 Accuracy ................59 Technical Information ..........61 Technical Specifications ............. 61 Device Labels ................63 Troubleshooting ................64 Cleaning the Finger Chamber Lens ..........70 Menus ................71 Contact Information ............72 Page 6 of 72...
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Page 7: Introduction
Introduction What is the TensorTip Congratulations on purchasing our TensorTip medical device. We at Cnoga Medical put all our efforts into quality and accuracy when designing and manufacturing our devices. Please read this manual thoroughly in order to achieve maximum usage of the device. - Page 8 The TensorTip-VSM is able to measure and display the following parameters: Measure and Display Graph Display Peripheral Pulse Wave (PPW) (Systolic and Diastolic) SpO2 BP Waveform and BP Variation spot-check* TensorTip ECG is one side partial Peripheral Pulse Rate (PPR) ECG information Optional –...
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Page 9: Warnings, Cautions And Notes
Warnings, Cautions and Notes Cautions and Notes that used throughout this manual: Caution A caution indicates instructions, or cautionary notes which, if not followed, may result in damage to the equipment or to the quality of measurements Note Notes contain helpful information and tips Page 9 of 72... -
Page 10: Safety Notes
The device contains no user-serviceable parts. In case of a technical problem, only an authorized technician may repair the device. Do not drop the device. If the device dropped or physically damaged, discontinue use unless certified by CNOGA. Page 10 of 72... - Page 11 The TensorTip should not be stored with common household waste products. Limit a measurement to up to 5 minutes at a time. The device not intended for use in the presence of water or flammable substances. The TensorTip device can be operated by external batteries module or by external USB power supply and is classified as Class II.
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Page 12: Indications For Use
Indications for Use The CNOGA Medical's Non-invasive TensorTip VSM is a small, lightweight, portable, device intended for measuring and display of BP (Systolic and Diastolic), Peripheral Pulse Rate (PPR), SpO spot check and graphs . Measurement performed on capillary fingertip tissue (other than the thumb). The left ring finger is the recommended site. -
Page 13: Important Notice
Important Notice Caution To avoid damaging the device, do not ever attempt to push your finger in or pull your finger out of the Finger Chamber with the lid closed. Always open the lid to insert or extract your finger Page 13 of 72... -
Page 14: Inside The Box
Inside the Box TensorTip supplied with the following components: device Stand/Finger Chamber cover Protective pouch Finger Chamber internal closure User Manual Plastic cover External Batteries module Page 14 of 72... -
Page 15: Tensortip Components
TensorTip Components Finger Chamber Lid Opener Display External batteries module Option USB/Batteries Power Buttons Supply Page 15 of 72... -
Page 16: Device Care
The Option Buttons change functionality depending on the status of the device as displayed on the screen. An icon on the screen indicates the function of each button. Push the adjacent option button to select the desired function. Device Care The TensorTip contains sensitive electrical and electronic components and therefore: ... -
Page 17: Using The Vsm
Using the VSM Turning the Device On and Off Connect power supply or external batteries module. TensorTip turns on automatically when you initiate a measurement by closing the lid with your finger inserted, and turns off automatically 30 seconds after the last time any button was pressed. - Page 18 Time displayed by holding the On/Off button for one second. Note TensorTip will not automatically turn off during measurement, even if no button was pressed for 30 seconds. Page 18 of 72...
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Page 19: Icons
Icons The VSM contains four buttons. These buttons change functionality depending on the status of the device and is displayed on the screen by an icon that indicates the function of each button. The following icons will be displayed when appropriate: Back History Heart rate... - Page 20 Accept Reject Progress Scroll Down indicator Increase Decrease Inadequate Connection Signal Switch Switch Measured Measured display mode graph tissue is cold tissue is hot display mode Page 20 of 72...
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Page 21: Usb Power Supply& Battery Replacement
USB Power supply and Battery replacement. If external batteries used: 1. Three AAA batteries are required for the device function, using CNOGA batteries module only (Figure 1)- supplied with the device. Low-batteries icon will appear on the screen indicating that external batteries have exhausted their power and must be replaced. - Page 22 If USB power supply used: Use “medical” USB power supply only- USB A/M to Micro USB B/M 5 Pins Cable 1.5m Maximum Length. Figure 2: USB Power Supply Page 22 of 72...
- Page 23 Note If the display is blank and the button does not turn the device on,the power source is not connected properly or the external batteries need to be replaced. Once the power source is reconnected and/or external batteries replaced, press the button to turn the device on Page 23 of 72...
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Page 24: First-Time Operation
First-time Operation The first time TensorTip is activated, the date and time must be set and the devices self-test must be run. If the self-test has not completed successfully or if the date and time are not set, TensorTip will not allow normal operation. For instructions regarding running the devices self-test, see page 52. -
Page 25: Language Selection
Language selection The TensorTip is a multilingual device whereas the user can select the desired language of operation. In order to change operating language, choose Language from the Main Menu, Options, User Settings menu. Press the buttons to select desired language. Page 25 of 72... -
Page 26: Performing A Measurement
Performing a Measurement Performing a measurement is simple: while in a sitting position, open the Finger Chamber Lid, insert your finger (see section 3 in measurement procedure- page 30), close the lid, and turn the screen towards you. The results will appear automatically. In order to start a new measurement follow the instructions set in paragraph 6 in the measurement procedure section and start from beginning. - Page 27 You should be in a sitting position with your elbow resting on a firm surface. Your wrist should be relaxed and the arm extended. The device should hang on the finger downwards below the heart level and slightly above the supporting surface.
- Page 28 Check that a pulse waveform displayed. If not, try cleaning and reinserting your finger. Figure 3: Measuring Position Page 28 of 72...
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Page 29: Measurement Procedure
Measurement procedure 1. Before performing a measurement, make sure your fingernail clipped and then clean your fingertip using the finger wipe provided with your TensorTip. Dry your finger. Performing a measurement on a dirty or greasy fingertip may affect the results. 2. - Page 30 3. While holding the TensorTip with your right hand, insert the index, middle or ring finger (depending on which fits best) of your left hand with the bottom side of your finger in contact with the Chamber floor and touching the front of the Chamber.
- Page 31 6. TensorTip will automatically turn on and results will be shown within seconds. Open the lid and withdraw your finger to end the measurement. device will then automatically turn off after 30 seconds if no buttons are pressed. The measurement can be stopped at any time by pressing the button.
- Page 32 7. Switching Between Display Modes During measurement, well after measurement has stopped, you can switch between graphical displays modes. TensorTip can display graphs of either the FingerTip ECG Waveform, the Blood Pressure Waveform (BPW), Peripheral Pulse Waveform (PPW) or the Blood Pressure Measurement Variation (BP - Variation), to switch between the display modes, press ...
- Page 33 8. Remove and reinsert your finger to perform a new measurement. Caution Do not try to force your finger into or out of the Finger Chamber as this will damage the seal and may affect the function of the device. Make sure the device attached to your finger properly.
- Page 34 Important: Low blood perfusion in the fingertip may generate a weak signal, usually accompanied by the question mark as shown in the graph on the left picture (a), while picture (b) on the right represents a stable signal. The phenomena of low perfusion may occur when the fingertip is too cold.
- Page 35 Note: low blood pressure or low Spo2 might be a result of low perfusion in the fingertip. Warming the fingertip in order to stimulate the blood circulation can be achieved by casting your hand towards the ground, in this way larger amount of blood will flow to the fingers.
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Page 36: Interpreting Your Graphs
Interpreting your Graphs Please note that the below graphs are for indication and description purposes only. The outline and scales of the graph will be as shown in below graphs. The following graphs represent the average value of the changes in the blood pressure over time. - Page 37 Min_Diastolic_Amplitude > 0 (real value) since the blood volume in the blood vessels must be greater than zero otherwise the blood vessels would collapse. This basic volume of blood in the blood vessels generates the temporal average diastolic pressure. ...
- Page 38 Low perfusion of the blood in fingertip may have a disorder or low resolution waveform as in the following graphs (pictures (d), (e) and (f)) bellow. It is suggested to warm the fingertip by rubbing the fingertip. Picture (d) Picture (e) Picture (f) Page 38 of 72...
- Page 39 In cases of relatively high systolic blood pressure and relatively high diastolic blood pressure, the graph may be seen as in the following picture (g). Relatively high systolic amplitude Relatively high diastolic amplitude Picture (g) Page 39 of 72...
- Page 40 The following blood pressure waveform graphs (pictures (h) and (i)) may indicate that the stroke volume (or Cardiac Output) is relatively below normal. Furthermore, picture (h) indicates that the diastolic pressure is relatively low while picture (i) indicates that the diastolic pressure is relatively normal. For more information, we suggest consulting your health physician.
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Page 41: The Valsalva Maneuver
The Valsalva maneuver The Valsalva maneuver performed by moderately forceful attempted exhalation against a closed airway, usually done by closing the mouth, pinching the nose shut while pressing out as if blowing up a balloon. The normal physiological response consists of four phases. Initial blood pressure rise with peripheral pulse descends. - Page 42 The pressure on the chest released, allowing the pulmonary vessels and the aorta to re-expand. Venous blood can once more enter the chest and the heart, cardiac output begins to increase. Return of cardiac output Blood return to the heart enhanced by the effect of entry of blood, which had been dammed back, causing a rapid increase in cardiac output (24 seconds on).
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Page 43: Switching Between Display Modes
Switching Between Display Modes During measurement, as well as after the measurement has stopped, you can switch between the graphical display modes. TensorTip can display graphs of either the FingerTip ECG Waveform, the Blood Pressure Waveform (BPW), the Peripheral Pulse Waveform (PPW) or the Blood Pressure Measurement Variation (BP - Variation). -
Page 44: Saving Measurement Results In History
Saving Measurement Results in History TensorTip can keep the results of up to 100 measurements, saved in chronological order. To save the results of a measurement once it has been stopped, press Viewing History Viewing the measurement result history can be initiated either when a measurement has been stopped by pressing , or by selecting History on the Main Menu. -
Page 45: Viewing Last Results
Figure 4: Result History Viewing Last Results On the Main Menu, choose Last Results. The previous last result will be displayed. Page 45 of 72... -
Page 46: Viewing Results Over Pc
Figure 5: The Last Results Screen Viewing Results over PC The user may connect the TensorTip to a PC using Cnoga isolated USB cable. Special driver from Cnoga is required to view and save results on a PC. Optional . -
Page 47: Adjusting Display Brightness
Adjusting Display Brightness Choose Display Brightness from the Main Menu, Options, User Settings. Press the buttons to adjust. Figure 6: Brightness Screen Page 47 of 72... -
Page 48: Adjusting Blood Pressure Sensitivity
Adjusting Blood Pressure Sensitivity Choose BP Sensitivity from the Main Menu, Options, User Settings. Press the buttons to adjust. Low sensitivity - continuously displayed results represent up to 30 seconds reading average. Normal sensitivity - continuously displayed results represent conditional change-... -
Page 49: Adjusting Tensortip Perfusion
Adjusting TensorTip Perfusion You can adjust the blood perfusion by choosing TensorTip Perfusion from the Main Menu, Options, User Settings. Press the buttons to adjust. Low - the results will be adjusted to low perfusion situation. Normal - the results will be adjusted automatically by the device. ... -
Page 50: Setting Date And Time
Setting Date and Time Access Set Date and Time from Main Menu, Options, User Settings Select This Appears To Adjust Date Use the buttons to adjust each parameter. Use the button to move between parameters. When finished, press . To discard changes and go back to the options menu, press Page 50 of 72... - Page 51 Time Use the buttons to adjust each parameter. Use the button to move between parameters. When finished, press . To discard changes and go back to the options menu, press Page 51 of 72...
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Page 52: Product Self-Test
Product Self-Test TensorTip includes a self-test procedure to ensure that measurements provide accurate results. The self-test requires minimal user intervention, as described below. It is initiated in the following conditions: During the first-time operation of TensorTip. Periodically requested by the device ... - Page 53 Note The device will not allow measurement and any other operation until the self-test is successfully completed. Make sure you follow the TensorTip maintenance instructions to avoid self-test failures. Extract your finger from the chamber. Page 53 of 72...
- Page 54 Insert the arc black plastic into the chamber when the small pin of the arc goes into the small hole in the chamber center. Close the lid. Close the chamber entrance by the "finger chamber cover". Press the button near the icon.
- Page 55 A successful self-test or failure message appears. If the self-test failed see Troubleshooting, page 46 Page 55 of 72...
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Page 56: Viewing Product Information
Viewing Product Information From the Main Menu in Options choose Product Info. The model and serial numbers are displayed. Figure 8: The Product Information Screen Page 56 of 72... -
Page 57: Restoring Factory Defaults
Restoring Factory Defaults Choose Restore defaults from the Main Menu, Options, Factory Settings. All user settings will be restored to factory default values. Measurement results history, Last measurement results and Clock setting will be cleared. Figure 9: Restore Defaults Screen Page 57 of 72... -
Page 58: Sw Reset
SW Reset Choose Reset product from the Main Menu, Options. The device will be reset. Figure 10: Reset Product Screen Page 58 of 72... -
Page 59: Accuracy
Accuracy The Non Invasive TensorTip VSM is the first device in the world that is capable of measuring Hemodynamic blood pressure without the use of air pumping. While performing the measurement you should be relaxed and avoid any movement. If the measurement fails, you may try inserting a different finger that best fits the chamber without excessive pressure on the fingertip. - Page 60 Marker Ranges %MSER Data Display Refreshment (Mean Square Error) Blood Pressure Systolic Device Range: 90-240 Every second (mmHg) < 10% Tested Range: 90- 180(mmHg) Blood Pressure Diastolic Device Range: 30-130 Every second (mmHg) < 10% Tested Range: 46-97(mmHg) Oxygen Saturation Device Range: 25 -100 <...
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Page 61: Technical Information
Technical Information Technical Specifications Operating humidity 10-80% C – 45 Device Operating temperature LED Wavelength 600 nm < Wavelengths < 1100 nm Luminous Power Emission 625nm Up to 10000mcd (Millicandelas) Other wavelengths Up to 35mW/SR (Milliwatts per Steradian) Page 61 of 72... - Page 62 Altitude 2000m Dimensions 43.2mm x 47.65mm x 74mm (H x W x L). Weight 109 gr Battery 3 AAA batteries USB Cable Micro USB Disposal Contact local authorities for the location of a waste collection center near you. Page 62 of 72...
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Page 63: Device Labels
Device Labels The following symbols used throughout the TensorTip device labeling: Page 63 of 72... -
Page 64: Troubleshooting
Troubleshooting If you experience trouble with your device, check the following table. If the problem persists, have the device checked by an authorized technician only. Problem Possible Cause Solution There are two possible reasons: 1. Insure connection of 1. Power source (power power source. - Page 65 Problem Possible Cause Solution Clean the Finger Chamber Finger Chamber Lens is Lens. (See Cleaning the dirty Finger Chamber Lens page "Measurement failed" message Fingertip is not properly Reinsert your finger as appears during inserted shown on page 28 measurement Fingertip is dirty oily or Clean and dry your finger Fingernail is too long...
- Page 66 Problem Possible Cause Solution Finger is injured or not intact Use a different finger Finger is too big or too thin or too small Device moves during Do not move during measurement measurement Device is not positioned Position the device properly according to Figure...
- Page 67 Problem Possible Cause Solution One or more of the Contact our service "Critical failure product's hardware department nnn" (nnn stands components have failed, for the error id) and the device is not usable. Page 67 of 72...
- Page 68 Problem Possible Cause Solution Make sure that the chamber is T001: The Finger closed properly with the cover Chamber was not sealed and run self-test again. If the for light error persists, contact our service department. "Self-test error Make sure the Finger Chamber Lens is clean (See Cleaning #Tnnn"...
- Page 69 Problem Possible Cause Solution Use appropriate finger. Try ring or index finger. Finger is not inserted Finger is too cold. Warm your properly or is not suitable. finger. Inadequate Signal If your finger is warm and the Low perfusion of blood sing is continues being showed, please visit your...
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Page 70: Cleaning The Finger Chamber Lens
Cleaning the Finger Chamber Lens If the Finger Chamber Lens becomes dirty, it may not provide accurate results. Occasionally gently clean the chamber lens with a cotton swab moistened in alcohol (70%). Figure 11: Finger Chamber Lens Location Caution Finger Chamber Lens Do not clean the with damp or abrasive cleaners or solvents... -
Page 71: Menus
Menus Page 71 of 72... -
Page 72: Contact Information
Contact Information Europe CNOGA Medical Ltd. MedNet GmbH North Industrial Park Borkstrasse 10 Or Akiva, Israel 48163 Muenster • Germany Tel: +972 4 6361080 Fax: +972 4 6361321 www.cnoga.com E mail: info@cnoga.com NS-VSM-UM-02-00-01-0000, 14/01/2014, ver 10 Page 72 of 72...
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