Cnoga TensorTip MTX User manual

MTX
MTX
TENSORTIP
MATRIX
User Manual
MTX

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TensorTip™MTX
Vital Signs Monitor
User Manual

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CNOGA Medical Ltd.
TensorTip™
MTX™
User’s Guide
Revised: January 2018
Document #: MTX 1017
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: [e-mail]
For the latest User's Guide version, please enter our website (www.cnoga.com), support section,
downloads subsection.
PA020310
Europe
MedNet GmbH
Borkstrasse 10
48163 Muenster • Germany
Israel
5 Tarshish St. North Industrial Park,
Caesarea, 3088900, POB 3188
Tel: [phone], Fax: [phone]

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Table of Contents
Introduction ...................................................................... 7
What is the TensorTip.............................................................7
Safety Notes ..........................................................................10
Indications for Use .................................................................12
Important Notice ....................................................................13
Inside the Box........................................................................15
TensorTip Components...........................................................16
Device Care...........................................................................17
Using the MTX .................................................................. 18
Turning the Device On and Off ...............................................18

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Icons .....................................................................................19
Charging and Recharging TensorTip........................................21
First-time Operation ...............................................................24
Language selection.................................................................25
Setting Date and Time ............................................................26
Device Self-Test.....................................................................28
Virtual Arm Cuff....................................................................31
Adjusting Hemoglobin Sensitivity ...........................................32
Performing a Measurement .....................................................33
Measurement procedure..........................................................35
Switching Between Display Modes..........................................41
Saving Measurement Results in History ...................................41
Viewing History.....................................................................42

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Viewing Last Results..............................................................43
Bluetooth (BLE) Module ........................................................44
Bluetooth (BLE) Info..............................................................45
Adjusting Display Brightness ..................................................47
Viewing Product Information ..................................................48
Restoring Factory Defaults......................................................49
Software Reset.......................................................................50
Technical Information........................................................ 51
Technical Specifications .........................................................51
Device Labels ........................................................................53
Troubleshooting .....................................................................56
Cleaning the Finger Chamber Lens ..........................................61

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Appendixes........................................................................ 65
Interpreting your Graphs .........................................................65
The Valsalva maneuver...........................................................70
Accuracy...............................................................................72
Contact Information .......................................................... 75

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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 optimum use of the device.
TensorTip is a family of non-invasive devices that enable quick and painless
measurement of physiological parameters. The MTXTM is a member of the
TensorTip family designed to measure heart rate, blood pressure and blood
oxygen saturation by simply inserting your finger into one compact and
simple device.
Introduction

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The TensorTip-MTX is able to measure and display the following parameters:
*Optional
Numeric Display
Graph Display
Hemodynamics:
Peripheral Pulse Rate (PPR)
BP (Trending - Systolic and Diastolic)
Cardiac Output SV MAP
Optical cardio gram
BP Waveform and
Variation
Peripheral Pulse wave (PPW)
Hematology: Hemoglobin Hematocrit
RBC BV
Blood gases: SpO2spot-check partial CO2
pressure partial O2pressure pH O2CO2
Biochemistry: Hemoglobin A1C*
Note
The parameters vary according to the regulatory approval and the ordered device as
indicated on the device packaging. This user manual describes all the parameters.
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Warnings, Cautions and Notes
Cautions and Notes that are 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.
Introduction

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Safety Notes
•Read this user manual before using your TensorTip.
•Do not use the TensorTip on an injured finger or a finger with an open wound.
•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. Please consult your doctor
in case of any numerical or graphical results deviating from your normal
results.
•The device contains no user-serviceable parts. In case of a technical problem,
only an authorized technician is authorized to repair the device.
•Do not drop the device. If the device dropped or physically damaged,
discontinue use unless certified by CNOGA.
•The TensorTip should not be stored with common household and cleaning
products.
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•The device not intended for use in the presence of water or flammable
substances.
•The TensorTip device is classified as an internally powered device when
battery operated and Class II when mains powered. It also classified for
continuous operation, with a Type BF Applied Part.
•The use of RF (Radio frequency) in this product is licensed for use by the FCC,
CE, Japan, SRRC, Anatel. For further information on any potential restriction,
refer to documentation on BLE usage by the relevant authority.
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Indications for Use
The CNOGA Medical's non-invasive TensorTip MTX is a small, lightweight,
portable, device intended for measuring and display of BP (Systolic and Diastolic),
Peripheral Pulse Rate (PPR), SpO2spot check and graphs. Measurements are
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.
Caution
Please note, that the CNOGA Medical's Non-invasive
TensorTip MTX does not and cannot replace professional
medical advice.
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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.
Caution
Limit a measurement to up to 10 minutes at a time.
When temperature reaches 40°C in the finger
chamber, the measurement will be stopped
automatically, and the following message will
appear.
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Do not look directly into the TensorTip Measurement Chamber.
Do not operate the unit in the presence of electromagnetic
interference. Interference may be caused by electrosurgery,
diathermy, magnetic resonance imaging or other equipment.
Portable and mobile RF (Radio Frequency) communications
equipment may affect operation of this device. In case of
interference, move the device to a location away from the source
of interference.
Do not use the device in an oxygen rich environment.
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Inside the Box
TensorTip is supplied with the following components:
•MTXTM device
•Battery charger –Input 100v~-240v~, 50Hz –60Hz.
DC Output 5v / 1300mA
•Stand/Finger Chamber cover
•Protective pouch
•Self-Test Arc
•User Manual
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TensorTip Components
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.
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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 self-test ARC inside the chamber after self-test was
performed.
•Between measurements cover with the finger chamber with the finger
chamber cover.
Introduction

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Using the MTX
Turning the Device On and Off
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 is pressed. During a reading, the device will not turn
off. You can also manually turn the device on by pressing the On/Off button
( ) for 3 seconds.
Press the On/Off button for one second to display the time and battery status.
Note
TensorTip will not automatically turn off during measurement,
even if no button was pressed for 30 seconds.
Using the MTX

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Icons
The MTXTM 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 are content dependent and displayed according to the status of
the device:
Back
History
Heart rate
Oxygen
saturation
Blood
Pressure
CO2
Partial
Pressure
O2 Partial
Pressure
Mean
Arterial
Pressure
Capillary pH
Cardiac
Output
Blood
Viscosity
Hematocrit
Hemoglobin
Switch
Page
Stop
Retry
Using the MTX