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 mTABLET BP. 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 the 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 authorised 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. If stipulated by regulations local safety requirements must 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.
⚠️Local safety requirements are to be complied with, if so, required by regulations. If stipulated by regulations local safety requirements must 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.
Product description
The MESI mTABLET BP (MTABSYSBP) is a Wireless Blood Pressure System for dual-cuff blood pressure monitoring. It uses left or right cuff for measuring blood pressure, which is displayed on the MESI mTABLET (MTABSYSW).
2.1 WHAT IS IN THE PACKAGE
The MESI mTABLET BP diagnostic system package includes the following equipment:
Tubeless Blood Pressure Cuff Module (including size M cuffs for: Left arm, Right arm),
Wireless Medical Tablet System (separate packaging), and
4-port Charging Station Module (separate packaging).
2.1.1 ACCESSORIES
⚠️Use only accessories and other parts recommended or supplied by MESI. Use of other than recommended or supplied parts 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 BP is an automatic electronic sphygmomanometers system which noninvasively measures patient’s arterial blood pressure on the upper arm. The system is intended to perform, view and store blood pressures of adult patients. It is a wireless system which is comprised of a wireless medical tablet system, tubeless blood pressure cuff module and a 4-port charging station module.
MESI mTABLET BP is intended to be used solely in a professional clinical environment by trained healthcare personnel which can correctly place blood pressure cuff on the upper arm, as well as able to verify that this cuff is inflating or deflating normally and to start the measurement process.
MESI mTABLET BP is intended to measure arterial blood pressure on the upper arm by using plethysmography method. The blood pressure result, heartrate, pulse wave and oscillation graph are captured and displayed as a numerical and graphical representation on MESI mTABLET UNIT.
The device is recharged through the AC/DC power supply, however, the MESI mTABLET BP is not intended to be used while connected to mains electricity.
Technical specifications
Following are the technical information regarding the MESI BP MODULE, its measurement and tubeless cuff provided within the package.
3.1 MESI TUBELESS CUFF UNIT (CUFFMD)
3.1.1 DIMENSIONS
Width: 40 mm (1.57 inches)
Depth: 40 mm (1.57 inches)
Height: 150 mm (5.91 inches)
Weight: 286 g
3.1.2 POWER & BATTERY
| Column A | Column B |
|---|---|
| Battery type | Rechargeable Lithium-Polymer battery |
| Capacity | 1240 mAh |
| Examinations per battery charge | > 200 |
3.1.3 CUFF SIZES
| Column A | Column B |
|---|---|
| Medium size cuffs | Tubeless cuff - Medium - RA Tubeless cuff - Medium - LA |
| Circumference | 22-32 cm |
| Large size cuffs | Tubeless cuff - Large - RA Tubeless cuff - Large - LA |
| Circumference | 32-42 cm |
3.1.4 CLASSIFICATION
| Column A | Column B |
|---|---|
| Protection against electric shock | Class II equipment |
| Medical device classification | Class IIa |
| Applied parts | Type BF Applied part |
| Software classification | Class B |
| RF emissions (CIPSR 11) | Group 1. Class B |
3.1.5 OPERATING CONDITIONS
| Column A | Column B |
|---|---|
| Temperature, operating | 10° to 40°C |
| Relative humidity | 25 to 85% (no condensation) |
| Pressure during operation | 700 to 1060 hPa |
| IP42 Rating |
⚠️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.
3.1.6 MEASUREMENT SPECIFICATIONS
Measurements using oscillometry and volume plethysmography:
Systolic blood pressure
Diastolic blood pressure
Heart rate
Measurement range:
Pressure: 0 to 299mmHg
Heart rate: 30 to 199 beats per minute
Max deviation:
Pressure: ± 3 mmHg
Heart rate: ± 5% of value
3.1.7 CONNECTIVITY
Data connectivity with MTABMD (Bluetooth 2.1 + EDR)
| Receiving section | Column B |
|---|---|
| Frequency range | 2401.3 MHz – 2480.7 MHz |
| Bandwidth | 0.930 MHz |
| Transmitter | Column B |
|---|---|
| Output power | 0.5 – 4.5 dBm |
| Frequency range | 2401.3 MHz – 2480.7 MHz |
| Modulation | GFSK |
3.2 TUBELESS CUFFS
The MESI mTABLET BP package includes one Tubeless Blood Pressure Cuff Module, with two medium size tubeless cuffs (left and right arm) for measuring blood pressure, mean arterial pressure (MAP) and heart rate.
Provided tubeless cuffs:
Right arm – red
Left arm - yellow
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 BP. For detailed description of individual functions of the device, see chapter 5 DETAILED INSTRUCTIONS
NOTE: When using the device for taking the blood pressure measurement the patient is sitting comfortably, has the back, elbow and forearm supported.
NOTE: The MESI mTABLET BP is intended for use in professional environment, where measurements must be carried out by adequately trained medical personnel. The MESI mTABLET BP is not intended for home use.
NOTE: This device is not intended for use on neonates, infants, or children under the age of 12 years.
NOTE: The effectiveness of this device has not been established in pregnant, including pre-eclamptic patients.
NOTE: In case of the presence of intravenous cannulas or arteriovenous (AV) fistulas, the cuffs and measurement can cause injury to the limb.
NOTE: This monitor complies with the requirements of ISO 81060-2:2013. In the clinical validation study, K5 was used on 86 subjects for the determination of diastolic blood pressure.
NOTE: This monitor has not been validated for use on pregnant patients.
4.1 PREPARATION FOR MEASUREMENT
⚠️MESI TUBELESS CUFF MODULE is a part of the MESI mTABLET BP system. Before starting a measurement be sure that you are familiar with all devices and their instructions which are part of the system.
4.1.1 PAIRING WITH A MESI mTABLET UNIT
Before any measurements can be performed the MESI TUBELESS CUFF UNIT (CUFFMD) needs to be paired to the MESI mTABLET UNIT. For detailed instructions please follow instructions in chapter 5.1.5 Pairing.
4.1.2 ASSEMBLY OF THE MESI TUBELESS CUFF UNIT
During shipping and transportation, the conical cuff is disconnected from MESI TUBELESS CUFF UNIT. Before first use connect the cuff to the port on the MESI TUBELESS CUFF UNIT as shown on the image below. Ensure that cuff is securely attached.
4.1.3 PATIENT PREPARATION
Patient needs to sit on a chair with feet flat on the floor and place arm on a table, so the cuff is level with heart. During the measurement process patient should not be talking and be relaxed as much as possible. It is advisable to wait 5 min before first reading is taken.
NOTE: Blood pressure reading can be affected by measurement site, the position of patient (standing, sitting, lying down) exercise, or patient’s physiologic condition.
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:
| POSITION | DESCRIPTION on the cuff | COLOR on the cuff |
|---|---|---|
| Right arm | RIGHT ARM | RED |
| Left arm | LEFT ARM | LEFT ARM |
Step 2 Place the cuffs to the appropriate arm
Position the cuff 1–2 cm above the elbow joint. Align the label Artery 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.
NOTE: Observe instructions for use that are provided with the cuff.
4.1.4 PERFORMING BLOOD PRESSURE MEASUREMENT
Step 1
On MESI mTABLET UNIT select existing patient (1) or add a new one (2) and press the ‘‘APPLICATIONS’’ button on the bottom of the screen (3).
Step 2
After selecting the patient, select the BP measurement in the application menu
NOTE: For additional information see MESI mTABLET instruction manual – chapter Patient management.
Step 3
Depending on the left or right arm choose and place the correct cuff (red or yellow). To begin the blood pressure measurement press START button.
4.2 RESULTS
Once the measurement has been taken the system will automatically switch to the results page where additional parameters of BP measurement can be viewed by scrolling up and down.
On the top the navigation menu provides the following actions:
NOTE: For more information about the result screen see chapter 5.4 REVIEWING A BLOOD PRESSURE MEASUREMENT.
Detailed instructions
This chapter contains all the information required by users of the device for 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 the operation of the device.
5.1 FIRST TIME USE
5.1.1 BASIC FUNCTIONALITIES
MESI mTABLET BP package consists out of a MESI TUBELESS CUFF UNIT diagnostic device and 2 tubeless cuffs. Before first use, the MESI TUBELESS CUFF UNIT needs to be paired with MESI mTABLET UNIT. Follow the instructions carefully.
5.1.2 AC/DC POWER SUPPLY AND BATTERY
The MESI TUBELESS CUFF UNIT uses two power sources. The mains electricity, using an AC/DC power supply for charging and battery power while performing measurement.
Connect the AC/DC power supply to a wall socket with a mains voltage of 100-240 V at 50-60 Hz and to the connector at the back of the device. The device is now recharging its battery. During this 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 5.5 MULTIFUNCTIONAL LED BUTTON.
5.1.3 ACTIVATION
When setting up 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 CHARING PLATE and a multifunctional button illuminates. It is recommended that, before initial use, the MESI TUBELESS CUFF UNIT is fully charged.
NOTE: The battery inside a completely new device is most likely not completely empty and can provide enough power to start the device up. Nonetheless, connect the device to the mains electricity using the AC/DC power supply before first 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 FIRST USE BATTERY STATUS
The MESI TUBELESS CUFF UNIT comes with an internal battery. To check the battery status, press multifunctional button on top of MESI TUBELESS CUFF UNIT. The button will respond by lighting up green or red depending on the battery state. 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 TUBELESS CUFF UNIT has to be paired with the MESI mTABLET UNIT. Take the MESI mTABLET UNIT and open user profile (for more information about user accounts see the USER PROFILE Chapter of the MESI mTABLET Instruction Manual) and observe the following instructions.
Step 1
Go to User profile > Settings > Modules > +Add module
Step 2
Press and hold the button on the top of the MESI TUBELESS CUFF UNIT until the multifunctional button light changes to blue.
Step 3
When the MESI mTABLET UNIT establishes a connection with MESI TUBELESS CUFF UNIT, the light on top of the module will change green. Confirm the pairing process by pressing the button on top of the module again.
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. It is possible to access all technical information about the connected modules in User profile >Settings > Modules > Connected modules
5.1.6 ATTACHING THE CUFFS
Before first use, cuffs should be disconnected from the MESI TUBELESS CUFF UNIT. The conical cuff can be orientated any way to the MESI TUBELESS CUFF UNIT. To connect the cuff, follow the next steps:
Step 1
Hold MESI TUBELESS CUFF UNIT firmly in your hands.
Step 2
Attach cuff to the MESI TUBELESS CUFF UNIT. You will hear a click sound when the tubeless cuff is securely attached.
5.1.7 DETACHING THE CUFFS
During transportation, each conical cuff should be disconnected from the MESI TUBELESS CUFF UNIT. To detach the cuff, follow the next steps:
Step 1
Hold MESI TUBELESS CUFF UNIT firmly in your hands.
Step 2
Push the sliding lock in the direction indicated on it 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
Select the patient tab button.
Step 2
Use the search bar (1) or scroll (2) to the patient who is having their blood pressure 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 BLOOD PRESSURE MEASUREMENT
During the test it is important that the patient is sitting comfortably, legs uncrossed, feet flat on the floor, has the back, elbow and forearm supported, palm-side up. Patient must relax as much as possible and not talk during the measurement procedure. Blood pressure reading can be affected by measurement site, the position of the patient (standing, sitting, lying down), exercise, or the patient´s physiologic condition.
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.
NOTE: Factors which can affect the performance of the automated sphygmomanometer and affect blood pressure reading are: common arrhythmias such as arterial or ventricular premature beats or atrial fibrillation, arterial sclerosis, poor perfusion, diabetes, age, pregnancy, pre-eclapsia, renal diseases, patient motion, trembling, shivering.
5.3.1 CUFF PLACEMENT
MESI mTABLET BP includes two cuffs to perform a measurement on either arm. The blood pressure measurement can be done with left arm cuff or right arm cuff. Choose the arm on which you want to measure blood pressure and select the appropriate cuff colour. Use red color cuff for measurement on the right arm and yellow cuff when performing measurement on the left arm.
BP MEASUREMENT – LEFT ARM PLACEMENT
The images below are presenting left arm placement (yellow cuff). The similar procedure follows for right arm (red cuff).
Position the cuff 1-2 cm above the elbow joint. Align the label Artery 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.
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: Be careful when wrapping the cuffs. Do not wrap them too tightly.
5.3.2 PERFORMING THE BP MEASUREMENT
Step 1
On the MESI mTABLET UNIT select existing patient (1) or add a new one (2). Then press the ‘‘APPLICATIONS’’ button (3). For additional information see chapter 5.2 Patient selection.
Step 2
After selecting a patient, select the BP application in application menu.
Step 3
Apply the cuffs to the appropriate arm – left or right arm. Press START.
NOTE: If 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 4
During the measurement there are blood pressure oscillations (Oscillation graph), cuff pressure progress (Progress bar) and cuff pressure (mmHg) presented on the screen.
NOTE: If the results of the measurement are unexpected, repeat the measurement three times.
5.4 REVIEWING A BLOOD PRESSURE MEASUREMENT
5.4.1 MESI MTABLET RESULTS SCREEN
When the measurement process is completed, result will be displayed on the screen. This consists of different areas: navigation area, parameters from the measurement (Systolic pressure, Diastolic pressure, Mean Arterial Pressure – MAP), oscillation graph and pulse wave form, reference, patient’s measurements history and comments on the result.
5.4.1.1 Navigation area
The buttons in the navigation area can toggle between previous and next measurement of the patient. If the user is not satisfied with the measurement for any reason, it can be discarded or repeated. In case of uncertainty, the user can consult with other doctors by simply sending the measurement through the email.
5.4.1.2 Measurement information
This section shows which arm was used during the measurement (left or right). Then the blood pressure measuring results follow with Systolic pressure (mmHg), Diastolic pressure (mmHg), Mean blood pressure (mmHg) and Heart rate (bpm).
By pressing “show more” button a reference scale will be shown which visually presents patient blood pressure according to the blood pressure classification in the ESH/ESC Guidelines for the management of arterial hypertension (2013).
5.4.1.3 Oscillation graphs and Pulse waveforms
History holds an overview of measurements taken by the same doctor on the same patient. It shows the trend of the patient’s results. By clicking on desired measurement, the user can switch between different measurements.
In this section, the entire BP measurement Pulse waveform graph and Oscillation graph are displayed.
5.4.1.4 Comments area
A comment can be added to every measurement. It will be stored and always available together with measurement report.
5.5 MULTIFUNCTIONAL LED BUTTON
5.5.1 LED INDICATORS
Even though most of the MESI TUBELESS CUFF UNIT control is performed through the MESI mTABLET UNIT interface there is still a multifunctional LED 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. These operations are based on the current status of the MESI TUBELESS CUFF UNIT.
5.5.1.1 Standby
Green: Battery capacity is more than 25%.
Red: Unit battery is less than 25%, please recharge the unit as soon as possible.
5.5.1.2 Charging
Green: Battery is fully charged.
Orange: Unit is charging.
5.5.1.3 Pairing
Blue: Unit is waiting for confirmation from the mTABLET.
5.5.2 BUTTON FUNCTIONS
5.5.2.1 Standby
| Column A | Column B |
|---|---|
| Status check | Quick press on button in standby mode will perform a basic status check of MESI TUBELESS CUFF UNIT – green, more than 25% battery charge, while red means less than 25% charge is left, and the module should be charged. |
| Pairing mode | Holding the button for 4 seconds will put the module into pairing mode where it can be connected to MESI mTABLET UNIT (for more information look at chapter 5.1.5 Pairing). |
| Resetting the BP diagnostic module | To perform a reset of the MESI TUBELESS CUFF UNIT press and hold the LED button for 10 seconds until it changes colour to red. Unit will be ready to use in a few seconds. |
5.5.2.2 Measurement mode
| Column A | Column B |
|---|---|
| Stop measuring | Pressing the top button on the MESI TUBELESS CUFF UNIT quickly while performing the BP measurement will stop the measurement. |
Maintenance
6.1 CHARGING THE BATTERY
The device can be only used on battery power therefore it has to be ensured that the battery is charged regularly. One battery charge is enough for approximately >200 measurements or 8 hours of continuous use.
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. For more information see chapter 5.5 MULTIFUNCTIONAL LED BUTTON.
If the capacity of the battery is significantly decreased after a certain period of intensive use, the battery is most likely spent, and it 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 – MESI TUBELESS CUFF UNIT:
Before cleaning remove the MESI TUBELESS CUFF UNIT from the charging station and disconnect the cuff from the MESI TUBELESS CUFF UNIT.
Use a soft lint-free cloth dampened with a proper cleaning agent to clean and disinfect the exterior/interior of the unit/.
With a dry cloth wipe off all residues of the cleaning solution.
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 – cuff:
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.
NOTE: 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.
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 – 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. 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 per month 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,
Performance of device in accordance to instructions for use,
The warning label’s legibility, and
The battery cycle count.
General warnings
⚠️ Before using the device for the first time, read the Instructions for Use carefully and follow the recommendations.
⚠️ The MESI ABI device users must be adequately educated to use the device. The education must be perfoThe MESI mTABLET BP device users must be adequately educated to use the device. The education must be performed by the trained MESI representative. Before the first use of the device, users must read the entire Instructions for Use carefully and follow the instructions for the use of the connected equipment.
7.1 PATIENT INJURY PREVENTION
⚠️Consecutively carrying out too frequent measurements may result in injury to the patient!
⚠️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 case of the presence of intravenous cannulas or arteriovenous (AV) f istulas in the limbs, the cuffs and measurement can cause injury to the 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. Pressurization of the cuff can temporarily cause 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.
⚠️Be careful when folding the cuffs. Do not fold them too tightly. Follow measuring instructions.
7.2 MEASUREMENT PROCEDURE
⚠️The MESI mTABLET BP is intended for blood pressure measurement on upper arm.
⚠️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 BP is not intended for use in conjunction with higher frequency 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).
⚠️When repeating the Blood Pressure measurement for several times a slight pain may appear at the measurement location. Other effects are excluded.
⚠️The cables and accessories may negatively affect the EMC performance. The device while operated should not be stacked closer than 30 cm from another medical device.
⚠️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 fields 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.
⚠️Read and follow cleaning instructions carefully.
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 BP device or protect the room containing the device from electromagnetic radiation.
⚠️Use only accessories and other parts recommended or supplied by MESI. Use of other than recommended or supplied parts may result in injury inaccurate information and/ or damage to the unit. Follow the instructions that are provided with the specific accessory.
Errors
| Error | Description | Solution |
|---|---|---|
| E3: Inflation insufficiency. Check the placement of the cuffs and repeat the measurement. | The cuff was insufficiently inflated. | Check the placement of the cuffs and repeat the measurement. |
| E7: Deflation insufficiency. Check the placement of the cuffs and repeat the measurement. | The cuff was insufficiently deflated. | The cuff is not attached or is not attached correctly. Attach the cuff correctly and repeat the measurement. |
| E8: An error occurred during systolic pressure calculation. | An error occurred during systolic pressure calculation. | Repeat the measurement. if the error is repeated, the measured value is outside the measurement range of the device. |
| E9: An error occurred during diastolic pressure calculation. | An error occurred during diastolic pressure calculation. | Repeat the measurement. if the error is repeated, the measured value is outside the measurement range of the device. |
| E10: An error occurred during mean pressure calculation. | An error occurred during mean pressure calculation. | Repeat the measurement. if the error is repeated, the measured value is outside the measurement range of the device. |
| E11: A large pressure fluctuation was detected. The patient may have moved. | A large pressure fluctuation was detected. The patient may have moved. | The results may be incorrect. Repeat the measurement. |
| N21: MESI TUBLESS CUFF Module not in range. | MESI TUBELESS CUFF UNIT is out of range (timeout). | Bring the MESI TUBELESS CUFF UNIT closer to the tablet and restart the ABI application. |
| N21: MESI TUBLESS CUFF Module not in range. | Connection between MESI TUBELESS CUFF UNIT and MESI mTABLET UNIT is not optimal. | Remove any mobile devices in proximity of MESI TUBELESS CUFF UNIT or bring the MESI mTABLET UNIT closer to the MESI TUBELESS CUFF UNIT. |
| N21: MESI TUBLESS CUFF Module not in range. | Depleted battery. | Place the MESI TUBELESS CUFF UNIT on the charging station. |
| N22: Module not paired with MESI mTABLET UNIT. | MESI TUBELESS CUFF UNIT is not paired to the MESI mTABLET UNIT. | Pair the MESI TUBELESS CUFF UNIT to the MESI mTABLET UNIT. For pairing see Chapter 5.1.5 Pairing. |
| N41: No cuff connected to MESI TUBLESS CUFF UNIT. | The cuff is disconnected from the MESI TUBELESS CUFF UNIT. | Disconnect the cuff from the MESI TUBELESS CUFF UNIT, turn it upside-down and reconnect it to the device. |
| E42: Please check the cuff position and repeat the measurement. If error is repeated, the measured value is outside the measurement range of the device. | The cuff on the patient limb is not correctly positioned. | Follow chapter 5.3.1 Cuff placement and place the cuffs correctly. |
NOTE: For “Abnormally weak pulse detected” message, please see chapter 8 ERRORS.
Troubleshooting
| Column A | New Column | Column B |
|---|---|---|
| Unexpected result. | Incorrect cuff placement. | Reread the instructions for use and place the cuffs correctly. |
| Unexpected result. | Patient moving during measurement. | Repeat the measurement process. |
| Unexpected result. | Wrong cuff size used. | Use cuffs of the correct size. |
| Unexpected result. | Possible air leakage. | Check the cuffs, the air tubes and the connectors and replace them if necessary. If you cannot fix the issue yourself, consult your dealer or the manufacturer. |
| Audible stretching of the fastening tape | Incorrect cuff placement. | Reread the instructions for use and place the cuffs correctly. |
| Audible stretching of the fastening tape | Wrong cuff size used. | Use cuffs of the correct size. |
| Continuously flashing purple or red indicator on CUFFMD | Incorrect state of the diagnostic module | Press and hold the button on top of the MESI TUBELESS CUFF UNIT (CUFFMD) for 15 seconds to restart it. |
| No light indication when pressing the CUFFMD multifunctional button. | Battery is empty | Place the MESI TUBELESS CUFF UNIT on the charging station and leave it to charge for at least half an hour before retrying. |
| The cuffs do not inflate. Hissing noises. | Possible air leakage. | Check the cuffs, the air tubes and the connectors and replace them if necessary. |
| Blood pressure measurement will not start even though the MESI TUBELESS CUFF UNIT is paired and next to MESI mTABLET UNIT | Nearby of device which produce electromagnetic interference. | Make sure that there aren´t any devices nearby which produce electromagnetic interference. If the problem continues, contact the manufacturer or local distributor for further assistance. |
| The cuffs do not inflate. Hissing noises. | Possible air leakage. | Check the cuffs, the air tubes and the connectors and replace them if necessary. If you cannot fix the issue yourself, consult your dealer or the manufacturer. |
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 given 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.
| Reference number | Description |
|---|---|
| EN 60601-1:2006/ A1:2013 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| EN 60601-1-2:2015 | Electrical medical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests (IEC 60601-12:2007, modified) |
| EN 60601-1-6:2010/ A1:2015 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| EN 80601-230:2010/A1:2015 | Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers |
| SIST EN 10601:2000+A2:2010 | Non-invasive sphygmomanometers. Part 1: General requirements |
| SIST EN 10603:2000+A2:2010 | Non-invasive sphygmomanometers – Part 3: Supplementary requirements for electromechanical blood pressure measuring systems |
| SIST EN 10604:2005 | Non-invasive sphygmomanometers – Part 4: Test procedures to determine the overall system accuracy of automated non- invasive sphygmomanometers |
| EN ISO 14971:2012 | Medical devices – Application of risk management to medical devices |
| EN ISO 109931:2009/AC:2010 | Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process |
| ISO 15223-1:2016 | Symbols for use in the labelling of medical devices |
| EN ISO 13485:2016 | Medical devices – Quality management systems Requirements for regulatory purposes |
| EN 62304:2006 +A1:2015 | Medical device software - Software life cycle processes |
11.1. MANUFACTURER DECLARATION ON EMC
MESI BP MODULE is a part of MESI mTABLET BP whose essential performance is performing a blood pressure measurement in specified operating conditions. The measurement is defined as measurement process and data storage to MESI mTABLET.
Due to the device’s 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 massages of any issues, while the cuff (if in use during the event) will deflate and cause no harm to the patient.
MESI mTABLET BP 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.
| Emissions test | Compliance | Electromagnetic environment - guidance |
|---|---|---|
| RF emissions CISPR 11 | Group 1 | The above listed models use RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. |
| RF emissions CISPR 11 | Class B | MESI mTABLET BP is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. |
| Harmonic emissions IEC 61000-3-2 | N/A | MESI mTABLET BP is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. |
| Voltage fluctuations / flicker emissions IEC 61000-3-3 | Complies | MESI mTABLET BP is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. |
MESI mTABLET BP 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
| Immunity Test | Test Condition | IEC 60601 Compliance level | Electromagnetic environment - guidance |
|---|---|---|---|
| Electrostatic discharge (ESD) according to IEC 61000-4-2 | ± 8 kV Contact ± 2, 4, 8, 15 kV Air | ± 8 kV Contact ± 15 kV Air | Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. |
| Conducted RF induced by RF fields IEC 61000-4-6 (a) | 3 Vrms 150 kHz - 80 MHz 6 Vrms in ISM bands between 150 kHz - 80 MHz c) 80% AM 1kHz | Exempt from this requirement - cable length is less than 3 m | - |
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 BP 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
| Immunity Test | Test Condition | IEC 60601 Compliance level | Electromagnetic environment - guidance |
|---|---|---|---|
| Electrostatic discharge (ESD) IEC 61000-4-2 | ±,8 kV Contact ± 2, 4, 8, 15 kV Air | ±8 kV Contact ± 15 kV Air* | Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30% |
| Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3 | 3 V/m 80 MHz – 2.7 GHz 80% AM 1 kHz | 3 V/m 80 MHz – 2.7 GHz | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3 | 385 MHz (18Hz Pulse Modulation) | 27 V/m | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3 | 450 MHz (FM+/-5 KHz deviation 1 kHz sine or 18 Hz Pulse Modulation) | 28 V/m | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3 | 710 MHz (217 Hz PM) | 9 V/m | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3 | 745 MHz (217 Hz PM) | 9 V/m | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3 | 780 MHz (217 Hz PM) | 9 V/m | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3 | 810 MHz (18 Hz PM) | 28 V/m | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3 | 870 MHz (18 Hz PM) | 28 V/m | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3 | 930 MHz (18 Hz PM) | 28 V/m | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3 | 1720 MHz (217 Hz PM) | 28 V/m | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3 | 1845 MHz (217 Hz PM) | 28 V/m | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3 | 1970 MHz (217 Hz PM) | 28 V/m | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3 | 2450 MHz (217 Hz PM) | 28 V/m | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3 | 5240 MHz (217 Hz PM) | 9 V/m | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3 | 5500 MHz (217 Hz PM) | 9 V/m | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3 | 5785 MHz (217 Hz PM) | 9 V/m | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| RATED power frequency magnetic fields IEC 61000-4-8 | 50 Hz or 60 Hz | 30 A/m | Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. |
MESI mTABLET BP 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
| Immunity Test | Test Condition | IEC 60601 Compliance level | Electromagnetic environment - guidance |
|---|---|---|---|
| Electrical fast transient/bursts IEC 610004-4 | ± 2 kV 100 kHz Repetition frequency | ± 2 kV | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Surges IEC 61000-4-5 | ± 0.5 kV, ±1 kV line(s) to line(s) ± 0.5 kV, ±1 kV , ± 2 kV line(s) to ground (a) | ± 1 kV Differential mode | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Conducted RF induced by RF fields IEC 61000-4-6 | 3 Vrms 150 kHz - 80 MHz 6 Vrms in ISM bands between 150 kHz - 80 MHz c) 80% AM 1kHz | 3 Vrms 150 kHz - 80 MHz 6 Vrms in ISM bands between 150 kHz - 80 MHz c) 80% AM 1 kHz | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 | 0% UT; 0°.45°, 90°, 135°, 180°, 225°, 270°, 315° 0% UT; 0° 0% UT; 70% 0% UT; 0% | 0.5 Cycles 1 Cycle 25/30 cycles (50/60 Hz) 250/300 Cycles (50/60 Hz) (5 s) | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. If the user of the above listed models requires continued operation during power mains interruptions, it is recommended that MESI mTABLET BP is powered from an uninterruptible power supply or battery. |
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 BP 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
| Immunity Test | Test Condition | IEC 60601 Compliance level | Electromagnetic environment - guidance |
|---|---|---|---|
| Electrostatic discharge (ESD) IEC 61000-4-2 | ±,8 kV Contact ± 2, 4, 8, 15 kV Air | ±8 kV Contact ± 15 kV Air | Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. |
| Electrical fast transient/bursts IEC 610004-4 (a) | ± 1 kV 100 kHz Repetition frequency | ± 1 kV | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Surges IEC 61000-4-5 (b) | ±2 kV line(s) to ground | Not applicable. | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
| Conducted RF induced by RF fields IEC 61000-4-6 (a) | 3 Vrms 150 kHz - 80 MHz 6 Vrms in ISM bands between 150 kHz - 80 MHz c) 80% AM 1kHz | 3 Vrms 150 kHz - 80 MHz 6 Vrms in ISM bands between 150 kHz - 80 MHz c) 80% AM 1 kHz | Mains power quality should be that of a professional healthcare facility environment and Home healthcare environment. |
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.
Guidance and manufacturer’s declaration - electromagnetic immunity
MESI mTABLET BP 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.
| Immunity test | IEC 60601 Test level | Compliance level | Electromagnetic environment - guidance |
|---|---|---|---|
| Conducted RF induced by RF fields IEC 61000-4-6 Radiated RF EM fields and Proximity fields from RF wireless communications equipment IEC 61000-4-3 | 3 Vrms 150 kHz - 80 MHz 6 Vrms in ISM bands between 150 kHz - 80 MHz c) 3 V/m 80 MHz – 2.7 GHz | 3 Vrms 150 kHz - 80 MHz 6 Vrms in ISM bands between 150 kHz - 80 MHz c) 3 V/m | Portable and mobile RF communications equipment should not be used no closer to any part of the above listed models, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.2√P d = 1.2√P 80 MHz - 800 MHz d = 2.3√P 800 MHz – 2.7 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range. (b) Interference may occur in the vicinity of equipment marked with the following symbol: |
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a) Field strengths from fixed transmitters such as base stations for radio (cellular/cordless) telephones, land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast, cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed 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.
b) Over the frequency range 150 kHz to 80 MHz, field strength should be less than 3 V/m.
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.
Recommended separation distances between portable and mobile RF communications equipment and the above listed models
MESI mTABLET BP 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 between portable and mobile RF communications equipment (transmitters) and the above listed models as recommended below, according to the maximum output power of the communication equipment.
Separation distance according to frequency of transmitter m
| Rated maximum output power of transmitter W | 150 kHz to 80 MHz d = 1.2√P | 80 MHz to 800 MHz d = 1.2√P | 800 MHz to 2.5 GHz d = 2.3 √P |
|---|---|---|---|
| 0.01 | 0.12 | 0.12 | 0.23 |
| 0.1 | 0.38 | 0.38 | 0.73 |
| 1 | 1.2 | 1.2 | 2.3 |
| 10 | 3.8 | 3.8 | 7.3 |
| 100 | 12 | 12 | 23 |
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: The ISM (industrial, scientific and medical) bands between 150 kHz 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.
NOTE 3: An additional factor of 10/3 has been incorporated into the formulae used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2,5 GHz to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. NOTE 4: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
Important labels
05-2021 / V. 1.2
General warnings
⚠️ Before using the device for the first time, read the Instructions for Use carefully and follow the recommendations.
⚠️ The MESI ABI device users must be adequately educated to use the device. The education must be perfoThe MESI mTABLET BP device users must be adequately educated to use the device. The education must be performed by the trained MESI representative. Before the first use of the device, users must read the entire Instructions for Use carefully and follow the instructions for the use of the connected equipment.
7.1 PATIENT INJURY PREVENTION
⚠️Consecutively carrying out too frequent measurements may result in injury to the patient!
⚠️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 case of the presence of intravenous cannulas or arteriovenous (AV) f istulas in the limbs, the cuffs and measurement can cause injury to the 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. Pressurization of the cuff can temporarily cause 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.
⚠️Be careful when folding the cuffs. Do not fold them too tightly. Follow measuring instructions.
7.2 MEASUREMENT PROCEDURE
⚠️The MESI mTABLET BP is intended for blood pressure measurement on upper arm.
⚠️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 BP is not intended for use in conjunction with higher frequency 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).
⚠️When repeating the Blood Pressure measurement for several times a slight pain may appear at the measurement location. Other effects are excluded.
⚠️The cables and accessories may negatively affect the EMC performance. The device while operated should not be stacked closer than 30 cm from another medical device.
⚠️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 fields 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.
⚠️Read and follow cleaning instructions carefully.
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 BP device or protect the room containing the device from electromagnetic radiation.
⚠️Use only accessories and other parts recommended or supplied by MESI. Use of other than recommended or supplied parts may result in injury inaccurate information and/ or damage to the unit. Follow the instructions that are provided with the specific accessory.
