MESI mTABLET ABI Instructions For Use Manual
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MESI mTABLET ABI Instructions For Use Manual

Ankle-brachial index
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Instructions
for Use
MESI mTABLET ABI
Ankle-Brachial Index
MTABSYSABI
ISO 9001
Q-1664
ISO 13485
M-049

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Summary of Contents for MESI mTABLET ABI

  • Page 1 Instructions for Use MESI mTABLET ABI Ankle-Brachial Index MTABSYSABI ISO 9001 Q-1664 ISO 13485 M-049...
  • Page 2 DISTRIBUTOR INFORMATION CONTACT INFORMATION Address MESI, development of medical devices, Ltd Leskoškova cesta 11a SI-1000 Ljubljana Slovenia, European Union Telephone +386 (0)1 620 34 87 E-mail info@mesimedical.com Website www.mesimedical.com...
  • Page 3 Instructions for Use MESI mTABLET ABI Ankle-Brachial Index ISO 9001 Q-1664 ISO 13485 M-049...

  • Page 4: Table Of Contents

    3.2 TUBELESS BLOOD PRESSURE CUFF MODULES 4 QUICK MEASURING GUIDE 4.1 PREPARATION FOR MEASUREMENT 4.1.1 Pairing with MESI mTABLET UNIT 4.1.2 Assembly of the MESI TUBELESS CUFF UNIT 4.1.3 Patient preparation 4.1.4 Performing ABI measurement 4.2 RESULTS 5 DETAILED INSTRUCTIONS 5.1 FIRST TIME USE...
  • Page 5 5.3 PERFORMING ABI MEASUREMENT 5.3.1 Cuff placement 5.3.2 Performing the ABI measurement 5.4 REVIEWING ABI MEASUREMENT 5.4.1 MESI mTABLET result screen 5.5 INTERPRETATION OF ABI RESULT 5.5.1 Detection of severe PAD and incompressible arteries 5.5.2 Pulse waveform 5.5.3 Oscilation graph 5.6 MULTIFUNCTIONAL BUTTON...

  • Page 6: Safety And Legal Recommendations

    SAFETY AND LEGAL RECOMMENDATIONS The MESI mTABLET ABI users must be adequately trained to use the device. Before the first use of the device, users must carefully read the entire instructions for use and follow the instructions for use of the connected equipment.

  • Page 7: Product Description

    PRODUCT DESCRIPTION 2.1 WHAT IS IN THE PACKAGE The MESI mTABLET ABI diagnostic system package includes the following equipment: PRODUCT • DESCRIPTION 4x Tubeless Blood Pressure Cuff Module (including size M cuffs for the left arm, right arm, left ankle and right ankle), •...

  • Page 8: Accessories

    4-port charging station module. MESI mTABLET ABI is intended to be used solely in a professional healthcare environment by trained healthcare personnel which can correctly place blood pressure cuffs on a patient’s body, verify that these cuffs are inflating or deflating normally and start the...
  • Page 9 PRODUCT DESCRIPTION The device is recharged through the AC/DC power supply, however, the MESI mTABLET ABI is not intended to be used while connected to mains electricity.

  • Page 10: Technical Specifications

    TECHNICAL SPECIFICATIONS Listed below is technical information regarding the MESI TUBELESS CUFF MODULE and its on-delivery specifications. TECHNICAL SPECIFICATI- 3.1 MESI TUBELESS CUFF UNIT (CUFFMD) 3.1.1 40 mm (1.57 inches) Width DIMENSIONS Depth 40 mm (1.57 inches) Height 150 mm (5.91 inches)

  • Page 11: Measurement Specifications

    TECHNICAL SPECIFICATIONS The MESI mTABLET ABI users must be adequately trained to use the device. Before the first use of the device, users must carefully read the entire the Instructions for Use and follow the Instructions for Use for connected equipment.

  • Page 12: Tubeless Blood Pressure Cuff Modules

    • Left arm - yellow • Right ankle – black • Left ankle – green NOTE For more information regarding approved cuffs and other accessories see instruction manual of the cuff available in the MESI package or contact your local distributor.

  • Page 13: Quick Measuring Guide

    Before using the device for the first time, read the Instructions for Use carefully and follow the recommendations and suggestions. This Chapter only includes short instructions for the use of the MESI mTABLET ABI. For detailed description of short instructions on the device, see Chapter 5 DETAILED INSTRUCTIONS.

  • Page 14: Assembly Of The Mesi Tubeless Cuff Unit

    MESI TUBELESS CUFF UNITS. Before first use connect the ASSEMBLY OF THE MESI cuffs to the port on the MESI TUBELESS CUFF UNIT as shown on TUBELESS the image below. Ensure that all cuffs are securely attached. CUFF UNIT 4.1.3...
  • Page 15 QUICK MEASURING GUIDE NOTE The cuffs can be connected to either of the MESI TUBELESS CUFF UNIT. The colour, size and positioning will be automatically detected by the MESI TUBELESS CUFF UNIT. Step 2 Place the cuffs to the appropriate arm/leg ARM: •...

  • Page 16: Performing Abi Measurement

    Observe instructions for use that are provided with the cuff. 4.1.4 PERFORMING ABI MEASUREMENT Step 1 Step 2 On the MESI mTABLET UNIT select an existing After selecting the patient, select the ABI patient (1) or add a new one (2). measurement in the application menu.
  • Page 17 QUICK RECORDING GUIDE Step 3 When starting the ABI application for the first time the default settings can be set by selecting between a 3-cuff or 4-cuff ABI measurement (when selecting a 3-cuff measurement, please select right or left arm) and confirming.

  • Page 18: Results

    MESI mTABLET ABI package consists out of four MESI TUBELESS 5.1.1 CUFF UNIT diagnostic devices and 4 tubeless cuffs. Before first BASIC FUNCTIONALITIES use, the MESI TUBELESS CUFF UNITS need to be paired with MESI mTABLET UNIT. Follow the instructions carefully.

  • Page 19: Ac/Dc Power Supply And Battery

    NOTE When the battery needs to be replaced, the MESI mTABLET UNIT will display a battery warning. For more information see Chapter 8 ERRORS. The MESI TUBELESS CUFF UNIT comes with an internal battery. To 5.1.4...

  • Page 20: Pairing

    Before any measurements can be performed the MESI TUBELESS PAIRING CUFF UNIT has to be paired with the MESI mTABLET UNIT. Take the MESI mTABLET UNIT, open user profile (for more information about user accounts see MESI mTABLET instruction manual, chapter MANAGING USERS) and observe the following instructions.
  • Page 21 DETAILED INSTRUCTIONS NOTE While operating only with one MESI mTABLET UNIT, performing this operation is required only once. In case of more MESI mTABLET UNITS this process will have to be repeated on each MESI mTABLET UNIT. Step 4 The final screen indicates successful connection between the MESI mTABLET UNIT and the MESI TUBELESS CUFF UNIT.

  • Page 22: Attaching The Cuffs

    DETAILED INSTRUCTIONS 5.1.6 Before first use, cuffs should be disconnected from the MESI ATTACHING TUBELESS CUFF UNIT. The conical cuff can be orientated any way THE CUFFS to the MESI TUBELESS CUFF UNIT. To connect the cuff, follow the next steps:...

  • Page 23: Detaching The Cuffs

    DETAILED INSTRUCTIONS 5.1.7 During transportation, each conical cuff should be disconnected from the MESI TUBELESS CUFF UNIT. To detach the cuff, follow DETACHING THE CUFFS the next steps: Step 1 Step 2 Hold MESI TUBELESS CUFF UNIT firmly in Push the sliding lock in the direction your hands.

  • Page 24: Patient Selection

    DETAILED INSTRUCTIONS 5.2 PATIENT SELECTION Before performing a measurement, patient needs to be selected or added to your working groups a patient list. 5.2.1 SELECTING A PATIENT Step 1 Step 2 Step 3 Select the patient tab Use the search bar Select the patient.

  • Page 25: Adding The Patient

    DETAILED INSTRUCTIONS 5.2.2 ADDING A PATIENT Step 1 Step 2 Step 3 On your home screen, Fill out required fields (Name, Save the patient by pressing press the button in the Surname, Date of Birth and button. Patient tab. Gender) and any additional information regarding the patient.

  • Page 26: Cuff Placement

    The ABI measurement can be made using with 4 or 3 PLACEMENT cuffs. When using 4 cuffs the MESI mTABLET ABI system uses the SmartArm™ algorithm to identify the arm with the higher systolic blood pressure, which will be used in the calculation of ABI.
  • Page 27 DETAILED INSTRUCTIONS Option 1: ABI measurement with 3 cuffs (right arm) Red cuff on right arm Black cuff on Green cuff on right leg left leg Option 1: ABI measurement with 3 cuffs (left arm) Yellow cuff on left arm Black cuff on Green cuff on right leg...
  • Page 28 DETAILED INSTRUCTIONS Place the appropriate cuff on left/right arm and position the ARM CUFF cuff 1-2 cm above the elbow joint. Make sure that the arrow- shaped artery marking is in line with the brachial artery. Place the cuff so that there is two fingers’ width of room between the limb and the cuff.
  • Page 29 Check that you have chosen the correct size using the SIZE marking and the OK area on the cuff. NOTE For other cuffs observe Instructions for use of the cuff available in the MESI TUBELESS CUFF MODULE package or contact your local distributor for more information.

  • Page 30: Performing The Abi Measurement

    PERFORMING AN ABI MEASUREMENT Step 1 Step 2 Step 3 On the MESI mTABLET After selecting a patient, Select the type of UNIT select an existing select the ABI application in measurement – 4 cuffs or patient or add a new one.
  • Page 31 DETAILED INSTRUCTIONS NOTE If the MESI TUBELESS CUFF UNIT has low battery or connectivity issues, a warning will be displayed on the instructions screen. In case of errors please consult Chapters 8 ERRORS and 9 TROUBLESHOOTING. Step 5 Apply the cuffs to the appropriate locations (arm/legs) according to Chapter 5.3.1...

  • Page 32: Reviewing Abi Measurement

    DETAILED INSTRUCTIONS 5.4 REVIEWING AN ABI MEASUREMENT Share for second opinion Discard result Navigation area Go to: Application screen Right and Left Ankle-Brachial Index SmartArm™ automatic higher blood pressure result Measurement parameters Oscillation graphs and Pulse waveforms Patient’s ABI history Comment Navigation area...

  • Page 33: Mesi Mtablet Result Screen

    DETAILED INSTRUCTIONS 5.4.1 When the measurement process is completed, results will be MESI MTABLET displayed on the screen. This consists of seven different areas: RESULTS SCREEN navigation area, ABI values, SYS/MAP/DIA blood pressure values and SmartArm™ selection, Oscilation graphs and Pulse waveforms, patient’s measurements history, comments on the result and another...

  • Page 34: Interpretation Of Abi Result

    The measurement of blood pressure with cuffs is not possible, and therefore the ABPI cannot be reliable. The patient should be referred for a Toe Brachial Index measurement. 5.5.2 The MESI mTABLET ABI uses the PADsense™ pattern recognitional PULSE algorithm to automatically interpret the acquired pulse waveform and WAVEFORM calculate the ABI with the result.
  • Page 35 Normal pulse waveform will display: a rapid rise in the upstroke during systole, a very sharp peak, a gradual downstroke, a presence of dicrotic notch. An absence of the dicrotic notch, a smaller amplitude, decreased slope and rounding of the systolic peak are the initial signs of a possible abnormality - the measured ABI value is lower than the one with normal pulse waveform.

  • Page 36: Oscilation Graph

    DETAILED INSTRUCTIONS As with the pulse waveform the MESI mTABLET ABI displays on 5.5.3 result page also oscillation graphs which provide the operator with OSCILATION GRAPH a pulse waveform analysis through the whole ABI measurement. Below are a couple of examples of different oscillation graphs:...

  • Page 37: Multifunctional Button

    DETAILED INSTRUCTIONS 5.6 MULTIFUNCTIONAL BUTTON Even though most of the MESI TUBELESS CUFF UNIT control is 5.6.1 performed through the MESI mTABLET UNIT interface there is still a LED INDICATORS multifunctional button on top of the device. Next to basic colour light notification functionalities of this button there is also a possibility to perform some additional operations.

  • Page 38: Button Functions

    MESI mTABLET UNIT (for more information look at Chapter 5.1.5 Pairing). Resetting the To perform a reset of the MESI TUBELESS ABI unit CUFF UNIT press and hold the LED button for 10 seconds until it changes colour to red.

  • Page 39: Maintenance

    One battery charge is enough for approximately 200 measurements. To charge the battery, place the MESI TUBELESS CUFF UNIT on the MESI LARGE CHARGING PLATE UNIT. During the charging process the light on the module will be flashing yellow. Only when the device is completely charged it will start flashing green.

  • Page 40: Disinfection

    Do not wash the cuffs in a washing machine or iron them. NOTE The device must be calibrated in the event of mechanical stress! 6.3 DISINFECTION Disinfection – MESI TUBELESS CUFF UNIT: Use commercially available disinfectants intended for the professional healthcare environment. Refer to the instruction for use of the producer.

  • Page 41: Product Life And Storage

    MAINTENANCE Non-approved disinfectants: • Organic solvents • Ammonia-based detergent • Abrasive cleaning agents • 100% alcohol, acetone, chlorine etc. Disinfection – cuff: • Can be disinfected with medical-grade alcohol 70%. • After disinfection, the cuff cover should be left air dry. 6.4 PRODUCT LIFE AND STORAGE If correctly used and maintained the device will have a minimum service life of 5 years.

  • Page 42: General Warnings

    Only use the device when it is completely dry. The MESI ABI is not intended for use in conjunction with high frequency surgical equipment. The AC/DC power supply must be connected to an easily accessible...
  • Page 43 The AC/DC power supply must be connected to an easily accessible socket (the AC/DC power supply also serves for galvanic isolation). The MESI ABI must not be used in an oxygen-rich environment. When repeating the Ankle-Brachial Pressure Index measurement or blood pressure measurement for several times a slight pain may appear at the measurement location.

  • Page 44: Maintenance

    The device is class A equipment and can cause radio interference or even cause nearby devices to cease to function. It may be necessary to reposition the MESI ABI device or protect the room containing the device from electromagnetic radiation.

  • Page 45: Errors

    ERRORS ERRORS Description Solution Error There were no If the error is repeated, No oscillations detected. oscillations detected. there is a possibility of ERRORS critical ischemia. Check the placement of the cuffs and repeat the measurement. An anomaly has been Remind the patient to remain An anomaly has been detected.
  • Page 46 Pair the MESI TUBELESS N22: MESI TUBELESS CUFF UNIT CUFF UNIT to the MESI Module not paired with is not paired to the MESI mTABLET UNIT. For pairing MESI mTABLET UNIT. mTABLET UNIT. see Chapter 5.1.5 Pairing. N23: High battery cycle Battery will need to be Replace battery.

  • Page 47: Troubleshooting

    Use cuffs of the correct size. Continuously Incorrect state of the Press and hold the button on flashing purple or diagnostic module top of the MESI TUBELESS red indicator on CUFF UNIT (CUFFMD) for 15 CUFFMD seconds to restart it. No light indication...

  • Page 48: Standard Compliance

    STANDARD COMPLIANCE The provisions of the Council Directive 93/42/EEC concerning medical devices were complied with. The standards in the table below were complied with. STANDARD Reference number Description COMPLIANCE EN 60601-1:2006/ Medical electrical equipment - Part 1: A1:2013 General requirements for basic safety and essential performance EN 60601-1-2:2015 Medical electrical equipment - Part 1-2:...

  • Page 49: Manufacturer Declaration On Emc

    – Requirements for regulatory purposes 11.1 MANUFACTURER DECLARATION ON EMC MESI mTABLET ABI is intended for use in the electromagnetic environment specified below. The customer or the user of the above listed models should assure that they are used in such an environment.
  • Page 50 STANDARD COMPLIANCE MESI mTABLET ABI is intended for use in the electromagnetic environment specified below. The customer or the user of the above listed models should assure that they are used in such an environment. Patient coupling PORT Electromagnetic Immunity Test...
  • Page 51 STANDARD COMPLIANCE MESI mTABLET ABI is intended for use in the electromagnetic environment specified below. The customer or the user of the above listed models should assure that they are used in such an environment. Enclosure Port Electromagnetic Immunity Test...
  • Page 52 STANDARD COMPLIANCE MESI mTABLET ABI is intended for use in the electromagnetic environment specified below. The customer or the user of the above listed models should assure that they are used in such an environment. Input a.c. power PORT Electromagnetic...
  • Page 53 STANDARD COMPLIANCE MESI mTABLET ABI is intended for use in the electromagnetic environment specified below. The customer or the user of the above listed models should assure that they are used in such an environment. Signal input/output parts PORT Electromagnetic...
  • Page 54 RF transmitters an electromagnetic site survey should be considered. If the measured field strength in the location in which MESI mTABLET ABI is used, exceeds the applicable RF compliance level above, the above listed models should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the above listed models.
  • Page 55 STANDARD COMPLIANCE MESI mTABLET ABI is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the above listed models can help prevent electromagnetic interference by maintaining a minimum distance...

  • Page 56: Essential Performance

    STANDARD COMPLIANCE/IMPORATNT LABELS 11.2 ESSENTIAL PERFORMANCE MESI ABI MODULE is a part of MESI mTABLET ABI whose essential performance is performing an ABI measurement in specified operating conditions. The measurement is defined as measurement process and data storage to MESI mTABLET.
  • Page 58 09-2019 / V. 1.0...

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