Cnoga TensorTip VSM User manual

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TensorTip™VSM
Vital Signs Monitor
User Manual

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CNOGA Medical Ltd.
TensorTip™
VSM™
User’s Guide
Revised: January 2014
Document #: VSM 1010
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
For the latest User's Guide version, please enter our website (www.cnoga.com), support section,
downloads subsection.
Europe
MedNet GmbH
Borkstrasse 10
48163 Muenster • Germany
Israel
North Industrial Park, Or Akiva, P.O.B. 136
Tel: +972 4 6361080 Fax: +972 4 6361321

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Table of Contents
1Introduction .......................................................................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

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2Using 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

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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

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3Accuracy.............................................................................59
4 Technical Information..............................................61
Technical Specifications.............................................................61
Device Labels ...............................................................................63
Troubleshooting............................................................................64
Cleaning the Finger Chamber Lens ..............................................70
5 Menus.............................................................................71
6Contact Information..........................................................72

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1Introduction
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.
TensorTip is a family of non-invasive devices that enable quick and painless
measurement of physiological parameters. The VSMTM is a member of the
TensorTip family calibrated to measure heartbeat, blood pressure and optional
blood oxygen saturation by simply inserting your finger into one compact and
simple device.

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The TensorTip-VSM is able to measure and display the following parameters:
Measure and Display
Graph Display*
BP (Systolic and Diastolic)
Peripheral Pulse Wave (PPW)
SpO2 spot-check*
BP Waveform and BP Variation
Peripheral Pulse Rate (PPR)
TensorTip ECG is one side partial
ECG information
*
Optional –SpO2 and graphs are optional and vary according to the regulatory approval
and the ordered device.

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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

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Safety Notes
Read this user manual before using your TensorTip.
Do not use the TensorTip on an injured or maimed finger.
Do not use the TensorTip on a dirty or wet finger.
The TensorTip should NOT BE used by children under the age of 18.
Do not use the device as a sole diagnostic indicator.
Do not look directly into the TensorTip Measurement Chamber.
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.

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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. It also classified as
applied part Type BF (IEC 60601-1) with continuous operation

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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), SpO2spot check and graphs. Measurement performed
on capillary fingertip tissue (other than the thumb). The left ring finger is the
recommended site. The results of each measurement are stored in the system memory.
The device intended for use in the home environment and as an additional support in
clinics.
It intended for use by any person aged above 18 years old.
Optional –SpO2 and graphs are optional and vary according to the regulatory approval
and the ordered device.

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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

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Inside the Box
TensorTip supplied with the following components:
VSMTM device
Stand/Finger Chamber cover
Protective pouch
Finger Chamber internal closure
User Manual
Plastic cover
External Batteries module

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TensorTip Components
Option
Buttons
Display
Finger Chamber Lid Opener
External
batteries module
USB/Batteries Power
Supply

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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:
Take care not to drop or damage the device.
When not in use store your TensorTip inside its pouch in a dry protected
environment.
Do not leave in direct sunlight or inside a car.
Do not expose the TensorTip to water or heat.
Do not leave the plastic cover inside the chamber after self-test performed.

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2Using 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. During a reading, the device will not turn
off. You can also manually turn the device on by holding the On/Off button ( )
for 3 seconds.

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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.

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Icons
The VSMTM 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
Oxygen
saturation
Blood
Pressure
Stop
Retry
Brightness
External
Battery
Status
Next
Save Results
Scroll Up

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Accept
Reject
Progress
indicator
Scroll Down
Increase
Decrease
USB
Connection
Inadequate
Signal
Switch
display mode
Switch
graph
display
mode
Measured
tissue is cold
Measured
tissue is hot
Table of contents