Safety and legal recommendations

1.1 LEGAL INFORMATION

All rights reserved. This publication may not be reproduced, copied or stored on a memory device. Furthermore, this publication may not be used for any purpose other than as the instructions for the use of the MESI TOE BLOOD PRESSURE UNIT and MESI TUBELESS CUFF UNITS (part of the MESI mTABLET TBI). This publication may not be translated into other languages or converted into other formats in any way without the prior written permission of MESI Ltd.

The contents of these Instructions for Use may be altered without notice. The latest version of the Instructions for Use is available at www.mesimedical.com/support/mtablet/instructions-for-use.

1.2 SAFETY INFORMATION

To avoid personal injury and/or damaging the device or accessories, follow the safety recommendations given below.

1.2.1 SETUP AND TECHNICAL PERSONNEL

The device must be set up by authorized personnel with adequate professional training and experience who are aware of all the dangers in relation to the setup of the device and its use and who will take adequate risk prevention measures for themselves, users, other personnel and devices.

1.2.2 ACCESS TO THE DEVICE

Only authorized persons may be given access.

1.2.3 SAFETY MEASURES

Local safety requirements are to be complied with, if so required by regulations. In addition to local safety regulations, the safety instructions in this document are also to be complied with. Should there be any conflict between the safety recommendations in this document and the recommendations stipulated by local regulations, the local regulations take precedence.

⚠️The MESI mTABLET TBI users must be adequately trained in use of the device. Users must carefully read the entire Instructions for Use prior to initial use of the device and follow the Instructions for Use for the connected equipment.

Product description

The MESI TBI MODULE is a wireless Toe-Brachial Index module designed for the MESI mTABLET TBI System. Toe-Brachial Index measurements and other parameters are displayed on the MESI mTABLET.

2.1 WHAT IS IN THE PACKAGE

The MESI TBI MODULE package includes the following equipment:

• Toe Blood Pressure Unit (TBPMD),

• 1x Toe Blood Pressure cable,

• Digit cuffs pair - Medium (ML, MR),

• Digit cuffs pair - Large (LL, LR),

• 2x Tubeless Cuff Unit (CUFFMD),

• 2x Tubeless Cuff - Medium (RA, LA),

• 120x pre-cut medical tape,

• 2x fastener strap,

• A wireless medical tablet system (separate packaging),

• A 4-port charging station module (separate packaging),

• Instructions for Use,

• Calibration Report, and

• Declaration of Conformity.

2.1.1 ACCESSORIES

NOTE: Contact your local distributor for more information about different cuff sizes and other accessories.

⚠️MESI mTABLET TBI users must be adequately trained in use of the device. Users must carefully read and follow the entire Instructions for Use prior to initial use of the device.

⚠️Only use accessories and other parts recommended or supplied by MESI. Use of parts not recommended or supplied by MESI may result in injury, inaccurate information and/or damage to the unit. Follow the instructions that are provided with the specific accessory.

2.2 INTENDED USE

The MESI mTABLET TBI is an automated wireless Toe-Brachial Index measuring system for screening patients for Peripheral Arterial Disease (PAD/LEAD). The system is intended to perform, view and store Toe-Brachial Index (TBI) measurements of adult patients - patients in the PAD risk group - especially diabetic, renal, and elder patients who may suffer from calcified vessels. It is a wireless system which is comprised of a wireless medical tablet system, toe blood pressure module, two tubeless blood pressure cuff modules and a 4-port charging station module.

The MESI mTABLET TBI is intended to be used in a professional clinical environment by trained healthcare personnels who understand the principle of Toe-Brachial Index (TBI) measurement and are able to place arm cuffs, digit cuffs and PPG probes on the patient body, as well as being able to verify that these accessories are working as intended, and to start the measurement process.

The MESI mTABLET TBI is intended to measure Toe-Brachial Index by performing non-invasive, plethysmography-oscillometric measurements of systolic brachial blood pressures and photoplethysmographic (PPG) measurements of systolic toe blood pressures. The Toe-Brachial Index result (along with used blood pressure values used in calculating the TBI), PPG waveforms, pulse wave and oscillation graph are captured and displayed as a numerical and graphical representation on the MESI mTABLET UNIT.

The MESI mTABLET TBI supports automatic, one-step measurements of systolic and diastolic brachial pressures and systolic blood pressures in big toes using standard software.

The device is recharged through an AC/DC power supply, however, the MESI mTABLET TBI is not intended to be used while connected to mains electricity..

Technical specifications

The technical information regarding the MESI TOE BLOOD PRESSURE UNIT and the MESI TUBELESS CUFF UNIT provided within the package is as follows:

3.1 MESI TOE BLOOD PRESSURE UNIT (TBPMD)

3.1.1 DIMENSIONS

Width: 40 mm (1.57 inches)

Depth: 40 mm (1.57 inches)

Height: 150 mm (5.91 inches)

Weight: 244 g

3.1.2 POWER & BATTERY

3.1.3 CUFF SIZES – TOE

3.2. MESI TUBELESS CUFF UNIT (CUFFMD)

3.2.1 DIMENSIONS

3.2.2 POWER & BATTERY

3.2.3 CUFF SIZES – ARM

3.3 DEVICE SPECIFICATIONS

3.3.1 CLASSIFICATION

3.3.2 OPERATING CONDITIONS

⚠️ If the device is used or stored outside the specified environmental parameters, the accuracy specified within the technical specifications of the device is not guaranteed.

3.3.3 MEASUREMENT SPECIFICATIONS

Measurements Using Oscillometry, Volume Plethysmography and Photoplethysmography:

• Toe-Brachial Pressure Index

• Systolic blood pressure (arms and toes)

• Diastolic blood pressure (arms)

• Heart rate

Measurement Range:

• Arm pressure: 0 to 299 mmHg

• Toe pressure: 20 to 250 mmHg

• Heart rate: 30 to 199 beats per minute

Max Deviation:

• Pressure: ± 3 mmHg

• Heart rate: ± 5% of value T

• oe-Brachial Pressure Index: ± 0.1

Temperature sensors for measuring skin temperature are integrated into both PPG probes. Skin temperature can vary significantly from core body temperature and is shown as additional information.

3.3.4 CONNECTIVITY

Data connectivity with MTABMD (Bluetooth 2.1 + EDR)

Receiving Section

Transmitter

Quick measuring guide

NOTE: 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 TBI. See Chapter 5 DETAILED INSTRUCTIONS for a detailed description of the device's individual functions.

NOTE: When performing TBI measurements patients must be in a supine position and remain still.

NOTE: The MESI mTABLET TBI may be used on pregnant women.

NOTE: The MESI mTABLET TBI is not intended for use on new-borns or children under 10 years of age.

NOTE: If intravenous cannulas or arteriovenous (AV) fistulas are present, cuffs and measurements can cause injury to the limb.

4.1 PREPARATION FOR MEASUREMENT

⚠️MESI mTABLET TBI users must be adequately trained in use of the device. Users must carefully read and follow the entire Instructions for Use prior to initial use of the device.

4.1.1 PAIRING WITH A MESI mTABLET UNIT

Before any measurements can be performed MESI TOE BLOOD PRESSURE UNIT and MESI TUBELESS CUFF UNIT devices need to be paired to the MESI mTABLET UNIT. For detailed instructions please follow the instructions in Chapter 5.1.5 Pairing.

4.1.2 ASSEMBLY OF THE MESI TOE BLOOD PRESSURE UNIT

The MESI Toe Blood Pressure cable should be disconnected during storage and transportation. Prior to initial use connect the toe blood pressure cable to the port on the MESI TOE BLOOD PRESSURE UNIT, as shown on the image below.

After ensuring that the cable is securely connected, attach the digit cuffs into corresponding cuff connector as shown on the image below. Please ensure that the cuff colours match the pressure hose colours.

4.1.3 ASSEMBLY OF THE MESI TUBELESS CUFF UNIT

During shipping and transportation, the conical cuffs should be disconnected from the MESI TUBELESS CUFF UNITS. Prior to initial use connect the cuffs to the port on the MESI TUBELESS CUFF UNIT as shown on the image below. Ensure that all cuffs are securely attached.

⚠️Only use accessories and other parts recommended or supplied by MESI. Use of accessories and other parts not recommended or supplied by MESI may result in injury, inaccurate information and/or damage to the unit. This product is not designed for sterile use.

4.1.4 PATIENT PREPARATION

The patient must be in supine position and remain still and quiet. One thin layer of clothing is allowed.

Step 1 Choosing the right colour of the cuff

Select the appropriate cuff, depending on the description and the colour of the cuff:

Step 2 Place the cuffs to the appropriate arm/leg

ARM:

• Place the appropriate cuff on left/right arm and position the cuff 1-2 cm above the elbow joint.

• Make sure that the arrow-shaped artery marking is in line with the brachial artery.

Step 3 Place the digit cuffs and photoplethysmographic probes to the appropriate big toe

Step 4 Place the cuffs on big toes

TOE:

• Place the appropriate digit cuff on the selected toe and wrap it around the base of it. Make sure the cuffs are wrapped around the toes tightly but comfortably.

• Place the PPG probe against the skin on the fleshy part of the appropriate big toe and secure it with the enclosed fastener strap or medical tape.

• Make sure that the vertical indicator line falls within area marked with the OK sign. If not, select an appropriately sized cuff.

NOTE: The arm cuffs can be connected to either of the MESI TUBELESS CUFF UNITS. The colour, size and positioning will be automatically detected by the MESI TUBELESS CUFF UNIT.

4.1.5 PERFORMING A TBI MEASUREMENT

Step 1

On the MESI mTABLET UNIT select an existing patient (1) or add a new one (2).

Step 2

After selecting the patient, please select the TBI measurement in the application menu.

NOTE: For additional information see the MESI mTABLET Instruction Manual – Chapter 8.1 PATIENT SELECTION.

Step 3

When starting the TBI application for the first time the default settings can be set by selecting between a 3-cuff or 4-cuff (1) TBI measurement (when selecting a 3-cuff measurement, please select right or left arm) and confirm (2).

Step 4

Observe the position indication on the cuffs and place them on the appropriate arm.

Step 5

Wrap the digit cuffs around the base of the appropriate big toe. Make sure that the cuffs are not too tight to prevent any residual pressure. Place the PPG probe against the skin on the fleshy part of the appropriate big toe and secure it with the enclosed fastener strap or medical tape. Afterwards press CONTINUE (1). Wait for PPG waveforms to stabilise. Once the waveforms are stabilised, press START (2) and wait until measurement is completed.

Step 6

If required use the calliper tool (1) by sliding the graph sideways to adjust the pressure reading. Afterwards press CONFIRM (2). By pressing the SKIP button (3), the result will be calculated with automatically detected pressures.

4.2 RESULTS

Once the measurement has been taken the system will automatically switch to the results screen. By scrolling on the results page additional TBI measurement parameters can be viewed. The following actions are listed on the top the navigation menu:

NOTE: For more information about the result screen see Chapter 5.4 REVIEWING TBI MEASUREMENTS

Detailed instructions

This Chapter contains all the information required by users of the device for a safe, correct and accurate measurement. It includes a detailed and complete description of all the functions of the device, safety instructions and all the information required to understand operation of the device.

5.1 FIRST TIME USE

5.1.1 BASIC FUNCTIONALITIES

MTABSYSTBI is a wireless system intended for measuring Toe-Brachial Index (TBI). System is comprised of MESI mTABLET UNIT, MESI TOE BLOOD PRESSURE UNIT, 2x MESI TUBELESS CUFF UNIT and MESI LARGE CHARGING PLATE (CS4SYS).

5.1.2 AC/DC POWER SUPPLY AND BATTERY

The MESI TOE BLOOD PRESSURE UNIT and MESI TUBELESS CUFF UNIT use two power sources: the mains electricity, using an AC/ DC power supply for charging, and battery power while performing measurements.

Connect the AC/DC power supply to a wall socket with a mains voltage of 100-240V at 50-60Hz and to the connector at the back of the device.

5.1.3 ACTIVATION

When setting up the MESI TOE BLOOD PRESSURE UNIT and the MESI TUBELESS CUFF UNIT for the first time it needs to be activated out of the shipping mode. The device will not respond until it is placed on the MESI LARGE CHARGING PLATE and a multifunctional button illuminates. It is recommended that, prior to initial use, the MESI TOE BLOOD PRESSURE UNIT and MESI TUBELESS CUFF UNITS are fully charged.

NOTE: The battery inside a completely new device is most likely to not be completely empty and can provide enough power to start the device up. Nevertheless, please recharge the batteries prior to initial use.

NOTE: When the battery needs to be replaced, the MESI mTABLET UNIT will display a battery warning. For more information see Chapter 8 ERRORS.

5.1.4 BATTERY STATUS

The MESI TOE BLOOD PRESSURE UNIT and MESI TUBELESS CUFF UNIT each come with internal batteries. To check a battery's status, press the multifunctional button on top of each UNIT. The button will respond and light up in green or red depending on the battery state. If the green light flashes, the module is ready for the next step. Otherwise, see the Chapter 6.1 CHARGING THE BATTERY for more information on battery charging.

5.1.5 PAIRING

Before any measurements can be performed the MESI TOE BLOOD PRESSURE UNIT and MESI TUBELESS CUFF UNIT devices need to be paired with the MESI mTABLET UNIT. Take the MESI mTABLET UNIT and open Doctor’s profile (for more information about user accounts see the USER PROFILE Chapter of the MESI mTABLET Instruction Manual).

Step 1

Go to User profile > Settings > Modules > +Add module

Step 2

Press the button on the top of MESI TOE BLOOD PRESSURE UNIT/MESI TUBELESS CUFF UNIT devices until the multifunctional button light changes to blue.

Step 3

When the MESI mTABLET UNIT establishes a connection with the MESI TOE BLOOD PRESSURE UNIT/MESI TUBELESS CUFF UNIT devices, the light on top of the module will change to green. Confirm the pairing process by pressing the button on top of the module again.

Step 4

The final screen indicates successful connection between the MESI mTABLET UNIT and the MESI TOE BLOOD PRESSURE UNIT and MESI TUBELESS CUFF UNIT devices. It is possible to access all technical information about the connected modules in User profile >Settings > Modules > Connected modules

NOTE: When operating with only one MESI mTABLET UNIT this operation is required only once. In instances where more MESI mTABLET UNITS are being used this process will have to be repeated on each MESI mTABLET UNIT.

NOTE: The pairing process needs to be done with all modules being used.

5.1.6 ATTACHING THE TOE BLOOD PRESSURE CABLE TO THE UNIT

Prior to initial use, during transportation and when storing for longer periods, the toe blood pressure cable should be disconnected from the MESI TOE BLOOD PRESSURE UNIT. To connect the toe blood pressure cable, follow the steps listed below:

Step 1

Firmly hold the toe blood pressure cable in your hands. Connect the toe blood pressure cable to the port on the MESI TOE BLOOD PRESSURE UNIT.

Step 2

After ensuring that the cable is securely connected, attach the digit cuffs into corresponding cuff connector. Please ensure that the cuff colours match the pressure hose colours.

NOTE: During transportation, the toe blood pressure cable should be disconnected from the MESI TOE BLOOD PRESSURE UNIT. To detach the toe blood pressure cable, push the side buttons on the connector and pull it out from the MESI TOE BLOOD PRESSURE UNIT.

NOTE: When detaching digit cuffs from the MESI Toe Blood Pressure cable, slightly rotate the cuffs.

5.1.7 ATTACHING THE ARM CUFFS TO THE UNIT

Prior to initial use, during transportation and when storing for longer periods, each cuff should be disconnected from the MESI TUBELESS CUFF UNIT. The conical cuff can be oriented any way to the MESI TUBELESS CUFF UNIT. To connect the cuff, follow the next steps:

Step 1:

Firmly hold the MESI TUBELESS CUFF UNIT in your hands.

Step 2

Attach the cuff to the MESI TUBELESS CUFF UNIT

5.1.8 DETACHING THE ARM CUFFS TO THE UNIT

During transportation, each conical cuff should be disconnected from the MESI TUBELESS CUFF UNIT. To detach the cuff, follow the steps listed below:

Step 1

Firmly hold the MESI TUBELESS CUFF UNIT your hands.

Step 2

Push the sliding lock in the indicated direction and detach the conical cuff.

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

Press the patient tab button on the home screen.

Step 2

Use the search bar (1) or scroll (2) to the patient who is having their TBI measured.

Step 3

Select the patient.

5.2.2 ADDING A PATIENT

Step 1

On your home screen, press the + button in the Patient tab.

Step 2

Fill out required fields (Name, Surname, Date of Birth and Gender) and any additional information regarding the patient.

Step 3

Save the patient by pressing the ✔️ button.

5.3 PERFORMING A TBI MEASUREMENT

During the test it is important that the patient is lying comfortably in supine position, legs uncrossed, elbow and forearm supported, palm side-up. Patient must relax as much as possible and not talk during the measurement procedure. You may keep the toes and feet warm by covering them with a blanket.

NOTE: It is recommended that the patient lies still for at least 5 minutes before starting the measurement process.

NOTE: The person carrying out the measurement should always remain by the patient’s side and closely monitor the measurement process.

5.3.1 CUFF PLACEMENT

The MESI automated wireless TBI system includes 2 digit cuffs and 2 arm cuffs. The TBI measurement can be made using 4 or 3 cuffs. When using 4 cuffs the MESI mTABLET TBI System uses the SmartArmTM algorithm to identify the arm with the higher systolic blood pressure, which can be used in the TBI calculation.

When using only 3 cuffs the user needs to identify the arm with the higher systolic blood pressure first and use it for the 3 cuff measurement.

NOTE: The measurement of the Toe Brachial Index can be affected by a limb's temperature, the position of the photoplethysmographic probe, placement of the cuffs, the position of the patient and their physical condition. The functioning of the device can also be affected by high temperature, humidity and altitudes.

TBI Measurement with 4 Cuffs

Option 1: TBI Measurement with 3 Cuffs (Right Arm)

Option 2: TBI Measurement with 3 Cuffs (Left Arm)

ARM PLACEMENT – PLACING THE CUFF ON THE ARM

Position the cuff 1-2 cm above the elbow joint. Align the artery label with the artery on inner side of an arm.

Place the cuff so that there is two fingers’ width of room between the limb and the cuff. Check that you have chosen the correct size using the SIZE marking and the OK area of the cuff.

TOE PLACEMENT – PLACING THE CUFF ON THE TOE

Position the module between the patient’s legs. Wrap the digit cuffs around the base of the appropriate big toe according to the colour coding. Make sure the cuffs are wrapped around the toes tightly but comfortably. The cuffs should not be placed too loosely. However, avoid fastening them too tightly, as this would prevent adequate blood flow and potentially cause discomfort.

Place the photoplethysmographic probe (PPG probe) against the skin on the pulp of the appropriate big toe and secure it with enclosed fastener strap or a medical tape. Probe should not create any additional pressure on the pulp of the toe.

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.

NOTE: Positioning the PPG sensor can influence the measurement result so it is important that the user tries several positions before finding the optimal signal strength.

5.3.2 PERFORMING THE TBI MEASUREMENT

Step 1

On your MESI mTABLET UNIT, select an existing patient or add a new one.

Step 2

After selecting the patient, please select the TBI measurement in the application menu.

Step 3

Select 3 cuff or 4 cuff measurement (when choosing 3 cuff measurement select right or left arm) and press OK.

Step 4

Amputation option – if a patient has amputated limb or is not compliant for TBI measurement due to severe and/or painful wounds, the user can deselect from the measurement.

Before a measurement is made the user can disable a selected cuff by pressing on the button and selecting the limb that is not compliant for measurement.

NOTE: If the MESI TUBELESS CUFF UNIT or MESI TOE BLOOD PRESSURE UNIT have low batteries or connectivity issues, a notification will be displayed on the instructions screen. In case of errors please consult Chapters 8 ERRORS and 9 TROUBLESHOOTING.

Step 5

Observe the position indication on the cuffs and place them on the appropriate arm.

Step 6

Wrap the digit cuffs around the base of the appropriate big toe. Place the PPG probe against the skin on the fleshy part of the appropriate big toe and secure it with the enclosed fastener strap or medical tape. Afterwards press CONTINUE.

Step 7

Check the signal and wait for the PPG waveforms of each toe to stabilise. You can amplify the signal strength by pressing the - (1) and + (2) buttons or wait a few moments for the device to adjust the signal strength automatically. Once the waveforms are stabilised, press START and wait until the measurement has been completed. The temperature next to the PPG waveforms displays the current skin temperature of each toe.

Step 8

During the measurement the arm pressure waveforms show pressure oscillation for each arm while the pressure next to the oscillation displays the current pressure in the corresponding cuff. The PPG waveforms for each toe show oscillation of the blood flow in each toe while the pressure next to the PPG waveforms displays the current pressure in the corresponding toe cuff. The progress bar shows the TBI measurement timeline. When the bar comes to an end the measurement of blood pressure is f inished and all the cuffs have deflated.

Step 9

If required use the calliper tool (3) by sliding the graph sideways to adjust the pressure reading. Afterwards press CONFIRM. The SKIP button will use automatic values and take you directly to the result screen. For more information regarding the result interpretation, oscillation or pulse waveform graph see Chapter 5.5.2 PPG PULSE WAVEFORMS INTERPRETATION AND TOE BLOOD PRESSURE.

5.4 REVIEWING A TBI MEASUREMENT

5.4.1 MESI MTABLET RESULTS SCREEN

When the measurement process is completed the result will be displayed on the screen. It consists of five different areas: Navigation Area, Measurement Parameters (Right/Left Toe Brachial Index, Systolic/Diastolic Pressure, Heart Rate), PPG Pulse Waveform Recordings, Oscillation Graphs and Pulse wave Forms, patient’s measurement history, comments on the result and another navigation area.

5.4.1.1 Navigation area

All the buttons and information placed in the navigation area are there to help you navigate the application. You can toggle between this patient's previous results. If you are not satisfied with the recording for any reason, you can quickly discard it. In case of uncertainty you can consult the measurement with a specialist by clicking on share button and entering their email address. You can either repeat the measurement or delete it. Or you can press the printer icon which will provide you with a printout of a selected measurement. The navigation menu also contains the names of both the doctor performing the recording and the patient.

5.4.1.2 Measurement information

This section shows the left and right toe-brachial index results along with the systolic and diastolic blood pressures of the arm that was used for the calculation.

Pressing the 'Show more' button will display more detailed information regarding systolic and diastolic blood pressure measurement (mmHg) on the arm/s and toe/s, the pulse rate (depending on which measurement option the user selected, i.e. the 3 cuff or 4 cuff measurement) and the skin temperature of each toe during the measurement.

5.4.1.3 PPG Pulse Waveform Recordings

In this field the entire PPG pulse waveform recordings in toes can be examined. For more information please see Chapter 5.5 INTERPRETATION OF A TBI RESULT.

5.4.1.4 Oscillation Graphs and Pulse Waveform Recordings

The entire TBI measurement pulse waveform (oscillation graph) or a detailed view (pulse waveform) can be examined in this section. For more information regarding the reading, oscillation or pulse waveform graph see Chapter 5.5 INTERPRETATION OF A TBI RESULT.

5.4.1.5 Patient measurement history

History holds an overview of measurements taken by the same doctor on the same patient. It shows the trend of the patient’s results for left and right TBI on a specific date.

5.4.1.6 Comments Area

A comment can be added to every measurement. It will be stored and always available together with a recoding report.

5.5 INTERPRETATION OF A TBI RESULT

5.5.1 DETECTION OF SYSTOLIC BLOOD PRESSURE IN TOES

When starting the measurement process, the device will start inflating cuffs on all selected extremities at once. At some point the digit cuffs will stop the blood flow in toes and continue with inflation to the point determined by the arm cuffs. The waveforms in the toes will level out. Right after reaching the maximum pressure, all four cuffs will start deflating simultaneously at a controlled rate.

At some point in the deflation phase the blood flow in toes will return and waveforms will re-establish. The very first returning waveform represents the point of systolic blood pressure in the toe. FirstWave™ algorithm will automatically detect it and position the cursor at the beginning of it.

NOTE: The external factors such as temperature, light conditions and patient movement can influence the blood flow in digital arteries which can influence the measurement result. If the results of the Toe-Brachial Pressure Index measurement are very unusual, repeat the measurement three times.

5.5.2 PPG PULSE WAVEFORMS INTERPRETATION AND TOE BLOOD PRESSURE

The MESI mTABLET TBI uses the unique FirstWave™ algorithm to automatically detect the first returning pulse waveform which indicates systolic blood pressure in the toes. However, the user has the option to reposition the cursor manually and select a different returning point for blood flow.

Understanding the PPG waveforms shape can help you make better decisions when manually selecting the returning point for blood flow.

In the first phase of the measurement, the device will start inflating cuffs on all selected extremities at once. At some point in the inflation phase, the digit cuffs will stop the blood flow in toes. The waveforms in toes will level out. The device will contintue with inflation until reaching the maximum pressure which will be defined automatically by the device itself.

Right after reaching the maximum pressure, all four (selected) cuffs will start deflating simultaneously at a controlled rate. At some point in the deflation phase the blood flow in toes will return and waveforms will re-establish. The very first returning waveform represents the point of systolic blood pressure in the toe. FirstWave™ algorithm will automatically detect it and position the caliper at the beginning of it.

Before confirming the selected waveform, the user has the option to re-position the caliper manually and select a different return point of the blood flow, by moving the caliper left or right.

Correct positioning of the caliper: caliper is positioned at the beginning of the first clearly visible waveform.

Wrong positioning of the caliper: caliper is not positioned on the f irst clearly visible waveform. The graph should be slid to the left.

Wrong positioning of the caliper: caliper is not positioned on the first clearly visible waveform. The graph should be slid to the right.

5.6 MULTIFUNCTIONAL BUTTON

5.6.1 LED INDICATORS

Even though control of most of the MESI TOE BLOOD PRESSURE UNIT and MESI TUBELESS CUFF UNIT functions is performed through the MESI mTABLET UNIT interface, there is still a multifunctional button on top of the devices. Next to the basic colour light notification functionalities of this button there is also a possibility to perform some additional operations. These operations are based on the current status of the MESI TOE BLOOD PRESSURE UNIT and MESI TUBELESS CUFF UNIT.

5.6.1.1 Standby

Green: Battery capacity is more than 25%.

Red: Unit battery is less than 25%, please recharge the unit as soon as possible.

5.6.1.2 Charging

Green: Battery is fully charged.

Orange: Unit is charging.

5.6.1.3 Pairing

Blue: Unit is waiting for confirmation from the mTABLET.

5.6.2 BUTTON FUNCTIONS

5.6.2.1 Standby

5.6.2.2 Measurement mode

Maintenance

6.1 CHARGING THE BATTERY

The TBI system modules can only be used on battery power, therefore you must ensure that the battery is charged regularly. One battery charge is enough for approximately >200 measurements or 3.5 hours of continuous use.

To charge the battery, place the modules 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. For more information see Chapter 5.6 Multifunctional Button.

If the capacity of the battery is significantly decreased after a certain period of intensive use, the battery is most likely spent and should be replaced. As the device does not contain any parts which can be replaced by a user, contact your local distributor or the manufacturer about replacing the battery.

6.2 CLEANING INSTRUCTIONS

⚠️Read and follow cleaning instructions carefully.

Cleaning the Device

The MESI TOE BLOOD PRESSURE UNIT, MESI TUBELESS CUFF UNIT devices, digit cuffs, probes and cuffs must be carefully cleaned and disinfected after every use and before use with a different patient. The digit cuffs/cuffs and probes can be reused on the same patient. If the digit cuff/cuff or probe is covered with dust and dirt, it can affect the performance of the device. Do not use aggressive cleaning agents, volatile liquids or excessive force when cleaning the device. Don’t dip the digit cuff/cuff and probe in liquids or cleaning agents.

Cleaning – MESI TOE BLOOD PRESSURE UNIT/MESI TUBELESS CUFF UNIT:

• Before cleaning remove the MESI TOE BLOOD PRESSURE UNIT/ MESI TUBELESS CUFF UNIT from the charging station and discon nect the cuffs and the toe blood pressure cable from the units.

• Use a soft lint-free cloth dampened with a proper cleaning agent to clean and disinfect the exterior/interior of the MESI TOE BLOOD PRESSURE UNIT/MESI TUBELESS CUFF UNIT.

• With a dry cloth wipe off all cleaning solution residue.

• Dry the equipment before next use.

• Recommended cleaning agents: Hydrogen peroxide (3%), Ethanol (70%), Isopropanol (70%), Mild soap (diluted), Ammonia (diluted), Sodium hypochlorite bleach (diluted)

Cleaning – cuffs/probes:

• Clean the cuff’s surface by wiping a damp cloth with mild soap water.

• Do not wash the cuffs or immerse it in water. Also do not use petrol, thinners or similar solvents to clean the cuffs.

⚠️Do not sterilise cuffs. Do not use bleach.

⚠️Wash and rinse temperatures should not exceed 40°C.

⚠️Do not, under any circumstances, immerse the unit or the cable assemblies in liquid.

⚠️Do not use high-temperature sterilisation processes (such as autoclaving).

⚠️Do not use e-beam or gamma radiation sterilisation.

NOTE: Do not wash the cuffs in a washing machine or iron them.

NOTE: In the event of mechanical stress, the device must be calibrated!

6.3 DISINFECTION

MESI TOE BLOOD PRESSURE UNIT/MESI TUBELESS CUFF UNIT:

For disinfection use commercially available disinfectants intended for a professional healthcare environment. Refer to the producer's Instructions for Use.

Approved disinfectants:

• Isopropyl alcohol 70%

• Propanol (70-80%)

• Ethyl hexanal

• Aldehyde (2-4%)

• Ethanol (70-80%)

Non-approved disinfectants:

• Organic solvents

• Ammonia-based detergent

• Abrasive cleaning agents

• 100% alcohol, acetone, chlorine etc.

Disinfection of the Cuff/Probe:

• 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. It is possible to store the device in suitable conditions for a maximum of 5 years. While in storage the battery needs to be recharged once every three months to avoid accidentally over-discharging the batteries. When using the device after storage, we recommend subjecting the device to a thorough maintenance check.

The device should be inspected by a qualified service engineer at least every 12 months for the following safety checks:

• Any mechanical or functional damage on the device and accessories,

• Device performance in accordance with the Instructions for Use,

• Legibility of warning labels, and

• Battery cycle count.

General warnings

⚠️ Prior to initial use of the device read the Instructions for Use carefully and follow the recommendations.

⚠️ The MESI mTABLET TBI device users must be adequately trained in use of the device. This training must be performed by a trained MESI representative. Prior to initial use of the device users must read the entire Instructions for Use carefully and follow the Instructions for Use of the connected equipment.

7.1 PATIENT INJURY PREVENTION

⚠️Do not place the cuffs on wounds, as this may cause additional injury. Only place the cuffs on the upper arms and lower legs.

⚠️In instances where intravenous cannulas or arteriovenous (AV) f istulas in the limbs are present, the cuffs and measurement can cause injury to the affected limb.

⚠️If the patient has had breast surgery, do not place the arm cuff on the side which has been operated on.

⚠️Do not use the device on a patient while they are connected to a vital sign monitor. Pressurisation of the cuff can temporarily cause the loss of function of simultaneously used monitoring ME equipment on the same limb.

⚠️Check the pressure in the cuff several times during measurement. If the cuff puts pressure on the limb for too long, it can impair the blood flow.

⚠️Consecutively carrying out too many measurements may result in injury to the patient.

⚠️Do not compress, bend or flatten the hose as this may result in the restriction of the connection tubing.

7.2 MEASUREMENT PROCEDURE

⚠️The MESI mTABLET TBI is intended for Toe-Brachial Index measurement with simultaneous measurement on upper arms and toes. The measurement of blood pressures, used for the calculation of the Toe Brachial Index should serve as an additional information only..

⚠️Do not use the device when it is wet. After cleaning the device with a damp cloth, wait for it to dry. Only use the device when it is completely dry.

⚠️The MESI mTABLET TBI is not intended for use in conjunction with highfrequency surgical equipment.

⚠️The AC/DC power supply must be connected to an easily accessible socket (the AC/DC power supply also serves for galvanic isolation).

⚠️Use of accessories and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

⚠️The MESI mTABLET TBI must not be used in an oxygen-rich environment.

⚠️Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment should be observed to verify that they are operating normally.

⚠️Portable RF communications equipment, including peripherals such as antenna cables and external antennas, should be used no closer than 30 cm (12 inches) to any part of the device, including cables specified by the manufacturer. This could result in degradation of the performance of this equipment.

⚠️When repeating the toe-brachial pressure index measurement or blood pressure measurement several times a slight pain may appear at the measurement location. Other effects are excluded.

⚠️Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

⚠️Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

⚠️Important information on electromagnetic compatibility (EMC). As the number of electronic devices such as computers and mobile phones in the room increases, medical devices can become sensitive to the electromagnetic influences of other devices. Electromagnetic interference can cause medical devices to malfunction, which can potentially lead to dangerous situations. Furthermore, medical devices must not interfere with other devices. The IEC/EN 60601-1-2 standard was introduced due to the necessity to establish electromagnetic compatibility (EMC) requirements for the prevention of dangerous situations in the use of medical devices. The standard defines the level of resistance to electromagnetic interference for medical devices. This medical device is compliant with the IEC/EN 60601-1-2 standard in terms of resistance to electromagnetic interference and electromagnetic emissions. Nevertheless, do not use mobile phones and similar devices which create strong electromagnetic f ields in the vicinity of the device. This can cause the device to malfunction, which can potentially cause a dangerous situation.

7.3 MAINTENANCE

⚠️Do not dispose the device as unsorted municipal waste. Prepare it for recycling or separate waste collection in accordance with Directive 2002/96/EC on scrap electrical and electronic equipment (WEEE).

⚠️To prevent electric shock hazard due to leakage current, only use AC/DC power supplies which are compliant with the technical specifications of the device.

⚠️Only use non-aggressive cleaning agents to clean the device. The device may be wiped with a damp cloth.

⚠️Be careful when wrapping the cuffs. Do not wrap them too tightly.

⚠️Make sure that the device does not come into contact with an electrical current while it is being cleaned.

⚠️Do not open the device. The device does not contain any parts which can be replaced by a user. Do not alter or adapt the device.

⚠️Protect the device from moisture and liquids and extremely high/low temperatures. Also protect the device from mechanical stress and do not expose it to direct sunlight, as this can cause the device to not function properly.

7.4 FUNCTIONING OF THE DEVICE

⚠️It is mandatory to have the device calibrated once per year to ensure the correct functioning and accuracy. Contact your dealer or the manufacturer about calibrating the device.

⚠️The device may only be used by professional medical personnel. 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 mTABLET TBI device or protect the room containing the device from electromagnetic radiation.

NOTE: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.

Errors

Troubleshooting

NOTE: If the problem continues, contact the manufacturer or the local distributor for further assistance.

Warranty information

A warranty period applies to the device, starting from the date of purchase (delivery date shown on the invoice). Warranty claims will only be valid if accompanied by the purchase receipt. More details about the warranty can be found in the warranty booklet attached to the applicable Instructions for Use.

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.

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.

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

Comment: *Not applicable, unit, without Signal input/output parts PORT

a) SIP/SOPS whose maximum cable length is less than 3 m in length are excluded.

b) This test applies only to output lines intended to connect directly to outdoor cables.

c) The ISM (industrial, scientific and medical) bands between 0.15 MHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.

The amateur radio bands between 0.15 MHz and 80 MHz are 1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz, 5.3 MHz to 5.4 MHz, 7 MHz to 7.3 MHz, 10.1 MHz to 10.15 MHz, 14 MHz to 14.2 MHz, 18.07 MHz to 18.17 MHz, 21.0 MHz to 21.4 MHz, 24.89 MHz to 24.99 MHz, 28.0 MHz to 29.7 MHz and 50.0 MHz to 54.0 MHz.

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

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Input a.c. power PORT

Comment:

a) Not applicable to CLASS II ME EQUIPMENT and ME SYSTEMS.

b) The ISM (industrial, scientific and medical) bands between 0.15 MHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. The amateur radio bands between 0.15 MHz and 80 MHz are 1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz, 5.3 MHz to 5.4 MHz, 7 MHz to 7.3 MHz, 10.1 MHz to 10.15 MHz, 14 MHz to 14.2 MHz, 18.07 MHz to 18.17 MHz, 21.0 MHz to 21.4 MHz, 24.89 MHz to 24.99 MHz, 28.0 MHz to 29.7 MHz and 50.0 MHz to 54.0 MHz.

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

Comment:

a) Not applicable to CLASS II ME EQUIPMENT and ME SYSTEMS.

b) The ISM (industrial, scientific and medical) bands between 0.15 MHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. The amateur radio bands between 0.15 MHz and 80 MHz are 1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz, 5.3 MHz to 5.4 MHz, 7 MHz to 7.3 MHz, 10.1 MHz to 10.15 MHz, 14 MHz to 14.2 MHz, 18.07 MHz to 18.17 MHz, 21.0 MHz to 21.4 MHz, 24.89 MHz to 24.99 MHz, 28.0 MHz to 29.7 MHz and 50.0 MHz to 54.0 MHz.

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.

Due to the devices high sensitivity, intended use and operating modes the device is susceptible to EM interferences. If the device essential performance is degraded, the device will notify operator with error messages of any issues, while the cuffs (if in use during the event) will deflate and cause no harm to the patient.

Important labels

08-2020 / V. 1.1