Cnoga TensorTip MTX User Manual
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Cnoga TensorTip MTX User Manual

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  • Page 1 T E N S O R T I P MATRIX User Manual...
  • Page 2 TensorTip™ MTX Vital Signs Monitor User Manual Page 1 of 75...
  • Page 3 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...

  • Page 4: Table Of Contents

    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 ..........
  • Page 5 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 ............
  • Page 6 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 ................
  • Page 7 Appendixes ................ 65 Interpreting your Graphs ............65 The Valsalva maneuver ............70 Accuracy ................72 Contact Information ............75 Page 6 of 75...

  • Page 8: 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 optimum use of the device.
  • Page 9 The TensorTip-MTX is able to measure and display the following parameters: Numeric Display Graph Display Hemodynamics: Peripheral Pulse Rate (PPR)  BP (Trending - Optical cardio gram Systolic and Diastolic)  BP Waveform and Cardiac Output  SV MAP Variation Hematology: Hemoglobin ...
  • Page 10 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. Page 9 of 75...

  • Page 11: Safety Notes

    • 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.
  • Page 12 • 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. •...

  • Page 13: Indications For Use

    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), SpO spot check and graphs. Measurements are performed on capillary fingertip tissue (other than the thumb). The left ring finger is the recommended site.

  • Page 14: 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. Caution Limit a measurement to up to 10 minutes at a time When temperature reaches 40°C in the finger...
  • Page 15 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.

  • Page 16: Inside The Box

    Inside the Box TensorTip is supplied with the following components: • device • Battery charger – Input 100v~-240v~, 50Hz – 60Hz. DC Output 5v / 1300mA • Stand/Finger Chamber cover • Protective pouch • Self-Test Arc • User Manual Page 15 of 75...

  • Page 17: Tensortip Components

    TensorTip Components The Option Buttons change functionality depending on the status device 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. Page 16 of 75...

  • Page 18: Device Care

    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. •...

  • Page 19: Using The Mtx

    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.

  • Page 20: Icons

    Icons The MTX 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: Oxygen Back...
  • Page 21 Switch Measured Inadequate graphs display tissue is Signal display mode cold mode Measured Large Arm Medium battery tissue is hot Cuff Arm cuff indicator Paired to Small Arm Cnoga Optical High Cuff host Cardiogram temperature device Page 20 of 75...

  • Page 22: Charging And Recharging Tensortip

    TensorTip (Figure 1). Leave the TensorTip plugged in until the battery icon indicates that it is full and the “Battery charging complete” message appears on the screen. In case of recharging the battery from a PC use only the CNOGA Isolated USB cable. Figure 1: USB Port Page 21 of 75...
  • Page 23 Note If the display is blank and the button does not turn the device on, the battery is discharged and recharging is necessary. Once the battery is charged, press the button to turn the device on Caution Even if the device is not in use, the battery must be charged every three months.
  • Page 24 Note The user cannot remove the battery. The battery is not user-replaceable and can be replaced only by CNOGA - authorized technicians only. Caution DO NOT dispose of batteries in fire as this can cause them to explode. Page 23 of 75...

  • Page 25: First-Time Operation

    First-time Operation Before first use, fully charge the battery. The first time TensorTip is activated, the language must be selected, 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.

  • Page 26: Language Selection

    Language selection The TensorTip is a multilingual device that allows the user to select the desired language of operation. The language will be set up as an initial setting and can be modified by the user any time during the device lifecycle. To change operating language, choose Language from the Main Menu, Options, User Settings menu, then press the buttons to select desired...

  • Page 27: 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 26 of 75...
  • Page 28 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 27 of 75...

  • Page 29: Device Self-Test

    Device 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, and is initiated in the following conditions: • During the first-time operation of TensorTip. • Periodically- requested by the device. •...
  • Page 30 Extract your finger from the chamber. Insert the black plastic self-test arc into the chamber so that the small pin on the arc enters the small hole in the chamber center. Note Please keep the ARC for future use. Page 29 of 75...
  • Page 31 Close the Lid and then close the chamber entrance using the "finger chamber cover". Press the button near the icon. The screen will turn red, green and blue accompanied by tones (in some models). The progress indicator appears. A successful self-test or failure message appears. If the self-test failed, see page 56.

  • Page 32: Virtual Arm Cuff

    Virtual Arm Cuff Before initiating a measurement, please adjust the Virtual Arm Cuff, choosing this option out of the Main Menu (Figure 3). Press the buttons to adjust. • - use for male with cold finger temperature, male/female with high body Large BMI or male/female suspected with high blood pressure •...

  • Page 33: Adjusting Hemoglobin Sensitivity

    Adjusting Hemoglobin Sensitivity For home users the default option is Normal range [5…25] You should adjust the Hemoglobin Sensitivity in any of the following cases, choosing this option out of the Main Menu. Press the buttons to adjust. • Lower Range [4…17] - use in case of suspected blood loss, intensive care, blood transfusion, or any case which requires high resolution of the lower hemoglobin range.

  • Page 34: Performing A Measurement

    Performing a Measurement Performing a measurement is simple: while in a sitting position, open the finger chamber lid, insert your finger, close the lid and turn the screen towards you (see Figure 5). Results will appear automatically. To start a new measurement, adjust the virtual arm cuff as described on page 30 and follow the instructions in Step 6 on page 37.
  • Page 35 • 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. see Figure 5. • Make sure that your fingernail is clipped. •...

  • Page 36: Measurement Procedure

    Measurement procedure 1. Before performing a measurement, make sure your fingernail is clipped and then clean your fingertip and dry your finger. Performing measurement on a dirty or greasy fingertip may affect the results. 2. Open the lid of the Finger Chamber by Finger Chamber pushing the button.
  • Page 37 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. The fingertip should not be pushing the front of the chamber and should completely cover the Chamber Lens.
  • Page 38 6. TensorTip will automatically turn on and results are displayed within seconds. Open the lid and withdraw your finger to end the measurement. The 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 39 7. To switch between the parameters pages, press To switch between the graphical displays modes, press 8. Remove and reinsert your finger to perform a new measurement. Page 38 of 75...
  • Page 40 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 that your finger is properly placed in the device. If your finger is too small and does not fill the Finger Chamber, the device might fail to operate correctly.
  • Page 41 Important: If the graphical display shows noisy signal (Figure 6A) or the parameters symbols are switched to question marks (Figure 6B), the measurement should be repeated following the instructions under Technical Information  Troubleshooting section on page 59. Figure 6C represents stable signal and measurement.

  • Page 42: 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 and between parameters pages. TensorTip can display graphs of either the FingerTip OCG Waveform, the Blood Pressure Waveform (BPW), the Peripheral Pulse Waveform (PPW) or the Blood Pressure Measurement Variation (BP - Variation).

  • Page 43: Viewing History

    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. Once the Result History screen is displayed (Figure 7), press to scroll up and down, and to switch between the parameters being displayed in the result list.

  • Page 44: Viewing Last Results

    Viewing Last Results On the Main Menu, choose Last Results. The previous last result is displayed (Figure 8). Figure 8: The last results screen Page 43 of 75...

  • Page 45: Bluetooth (Ble) Module

    Bluetooth (BLE) Module The BLE connection function of the TensorTip device is automatically in the device. You can turn ON/OFF BLE manually by choosing this option out of the user settings (Figure 9A). Figure 9A: BLE screen Page 44 of 75...

  • Page 46: Bluetooth (Ble) Info

    Figure 9B – Bluetooth info • Pairing code- during connection a pairing code Figure 9B). indicated in BLE info section will be requested by the APP ( For CNOGA_APP information please contact your CNOGA distributor. Page 45 of 75...
  • Page 47 Caution The content available through the TensorTip MTX and its accessory Apps, is for informational and educational purposes only and is not a substitute for the professional judgment of a health care professional in diagnosing and treating patients. Cnoga does not, through TensorTip MTX, provide medical advice, nor does it provide medical prescriptions, treatments, or diagnostic services.

  • Page 48: Adjusting Display Brightness

    Adjusting Display Brightness Choose Display Brightness from the Main Menu, Options, User Settings. Press the buttons to adjust (Figure 10). Figure 10: Brightness screen Page 47 of 75...

  • Page 49: Viewing Product Information

    Viewing Product Information From the Main Menu in Options choose Product Info. The model and serial numbers are displayed (Figure 11). Figure 11: Product information screen Page 48 of 75...

  • Page 50: Restoring Factory Defaults

    Restoring Factory Defaults Choose Restore defaults (Figure 12) from the Main Menu, Options, Factory Settings. All user settings will be restored to the factory default values. Measurement results history, Last measurement results and Clock setting will be cleared. Caution Restoring the device to factory default will delete...

  • Page 51: Software Reset

    Software Reset Choose Reset product (Figure 13) from the Main Menu, Options. The device will be reset. Figure 13: Reset product screen Note Performing Software Reset will NOT delete measurements stored on the device. Page 50 of 75...

  • Page 52: Technical Information

    Technical Information Technical Specifications Operating humidity 10-80% C – 40 Device Operating temperature Storage condition C-18 C with no direct sunlight, <60% humidity, stored in closed boxes without access to dust and dirt. finger chamber should be covered by designated rubber cover and the device is "standing"...
  • Page 53 Luminous Power Emission 625nm Up to 10000mcd (Millicandelas) Other wavelengths Up to 35mW/SR (Milliwatts per Steradian) Altitude 2000m Dimensions 43.2mm x 47.65mm x 74mm (H x W x L). Weight 99.9gr Battery Li-Polymer: PL802045-670mAH- Newsun, LCTV802045- LOWC Technology Co. Battery service life Six months Page 52 of 75...
  • Page 54 FW7333SM/05- Input: 100V to 240V; 50-60Hz Power supply Output: 5VDC, 1300mA FW8002MUSB/05- Input:100Vto240V;50-60Hz Output: 5VDC, 1400mA Service life of the device One year Service life of parts and One year accessories USB Cable Micro USB Disposal Contact local authorities for the location of a waste collection center near you.

  • Page 55: Device Labels

    Device Labels The following symbols used throughout the TensorTip device labeling: Page 54 of 75...
  • Page 56 At the end of its useful life, the product should be disposed of in accordance with local regulations covering disposal of electronic products. Caution The device must be powered from mains only by dedicated power supplies, which are provided with the device and/or certified by CNOGA distributers. Page 55 of 75...

  • Page 57: 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 Device will Battery is discharged Recharge the battery not turn on "Critical One or more of the product's Contact our service...
  • Page 58 Problem Possible Cause Solution Finger Chamber Lens is dirty Clean the Finger Chamber "Measurement Lens. (See Cleaning the failed" message Finger Chamber Lens, page appears during measurement Fingertip properly Reinsert your finger as inserted shown on page 37 Fingertip is dirty oily or wet Clean and dry your finger Fingernail is too long Clip fingernail prior to use...
  • Page 59 Problem Possible Cause Solution Device was moved during Do not move during measurement measurement Device is not positioned Position the device according to “Performing a properly Measurement” page 33 Fingertip temperature is too Warm your measured finger prior to use Page 58 of 75...
  • Page 60 Problem Possible Cause Solution Finger is not inserted properly Remove your finger and or is not suitable. insert again. Use different finger. Try ring or index finger. Check that arm cuff is correctly defined. Finger is too cold. Warm Inadequate Signal Low perfusion of blood.
  • Page 61 Problem Possible Cause Solution "Self-test error T001: The Finger Make sure that the chamber #Tnnn" during self- Chamber was not sealed is closed properly with the test for light cover and run self-test again. If the error persists, contact service T002-T020: optical unit department.

  • Page 62: 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 (Figure 14) with a cotton swab moistened in alcohol (70%). Figure 14: Finger chamber lens location Caution Do not clean the Finger Chamber Lens with damp or abrasive cleaners or...
  • Page 63 Hardware Reset Insert a pin gently into the hole in the chamber base to reset the hardware. Page 62 of 75...
  • Page 64 Menus Page 63 of 75...
  • Page 65 • The use of TensorTip MTX, does not establish a physician-patient relationship. • If you have any concerns or questions about your health, you should always consult with a physician or other healthcare professional.

  • Page 66: Appendixes

    Appendixes Interpreting your Graphs Caution 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. Please note that the below graphs are for illustration purposes only. The outline and scales of the graph will be as shown in below graphs.
  • Page 67 • The following graphs represent the average value of the changes in the blood pressure over time. See Figure 15 for additional explanations. • blood pressure waveform normalized between zero Max_Systolic_Amplitude. Therefore, the blood pressure slope decreases to zero (scale value). Min Diastolic Amplitude scaled during each cycle to zero. •...
  • Page 68 • The systolic amplitude decreases from Max_Systolic_Amplitude until reaching a point on the graph slope denoted by Min_Systolic_Amplitude. This point also represents the Max_Diastolic_amplitude. From that point the amplitude continues to decrease until reaching Min_Diastolic_Amplitude. This point is normalized to zero so the whole graph is scaled between zero to Max_Systolic_Amplitude.
  • Page 69 • In cases of relatively high systolic blood pressure and relatively high diastolic blood pressure, the graph appears as in Figure 17. Relatively high systolic amplitude Relatively high diastolic amplitude Figure 17: Relative graph amplitudes Page 68 of 75...
  • Page 70 • The following blood pressure waveform graphs (Figure 18) may indicate that the stroke volume (or Cardiac Output) is relatively below normal. (A) may indicate that the diastolic pressure is relatively low while (B) may indicate that the diastolic pressure is relatively normal. For more information, we suggest consulting your physician.

  • Page 71: The Valsalva Maneuver

    The Valsalva maneuvers The Valsalva maneuver is 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 72 Pressure release. 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 is enhanced by the effect of entry of blood, which had been dammed back, causing a rapid increase in cardiac output (24 seconds on).

  • Page 73: Accuracy

    Accuracy The MTX was assessed in a study conducted with marketed reference devices and handheld oximeters. Following are the accuracy values: Marker Ranges %MSER Data Display Refreshment (Mean Square Error) Device Range: 90-240 (mmHg) Blood Pressure 5.5-7.9 Every second Tested Range: 90-180(mmHg) Systolic mmHg Device Range: 30-130 (mmHg)
  • Page 74 Hemoglobin Device Range: 5 - 25 (g\dl) 0.5- Every second Tested Range: 8 – 18 ((g\dl) 0.98g/dL Hemoglobin A1C Device Range: 4-19 (mmol\L) ±8% Every second Tested Range: 4.16-9.12 (mmol/L) Device Range: 10-300 (mmHg) 5.99mmHg Every second Tested Range: 40-100 (mmHg) Device Range: 20-150 (mmHg) 5.3mmHg Every second...
  • Page 75 Device Range: 5-50 (ml\dL) ±1.15% Every second Tested Range: 10-26 (ml\dL) Device Range: 15-35 (mmol/L) ±4.75% Every second Tested Range: 23-39 (mmol/L) Device Range: 10-300 (ml) 26.9% Every second Tested Range: 30-140 (ml) Page 74 of 75...

  • Page 76: Contact Information

    Contact Information Cnoga Medical LTD. Europe MedNet GmbH 5 Tarshish St. North Industrial Borkstrasse 10 Park, Caesarea , 3088900, 48163 Muenster • Germany P.O.B. 3188. Israel. Tel: +972 4 6361080 Fax: +972 4 6361321 www.cnoga.com E mail: info@cnoga.com PA020310, 07.01.2018 ,V.17...

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