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 SPO2. 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.

⚠️The MESI mTABLET SPO2 users must be adequately trained to use the device. Before the first use of the device, users must carefully read the entire instructions for use and follow the instructions for use of the connected equipment.

Product description

MESI SPO2 MODULE is a wireless pulse oximeter module designed for MESI mTABLET SPO2 system. The peripheral oxygen saturation and pulse rate measured on MESI PULSE OXIMETER UNIT are simultaneously displayed on the MESI mTABLET.

2.1 WHAT IS IN THE PACKAGE

The MESI SPO2 MODULE package includes the following equipment:

• MESI PULSE OXIMETER UNIT (SPO2MD)

• FingerClip Sensor (CS10299)

• Instructions for use

• MESI LARGE CHARGING PLATE – (CS4SYS; separate packaging)

• MESI mTABLET (MTABMD; separate packaging)

2.1.1 ACCESSORIES

Detailed information regarding specific sensor use (patient population, body/tissue, and application) can be found in the respective sensor Instructions for Use.

NOTE: Contact your local distributor for more information about different sensors and other accessories. Use only ChipOx® compatible sensors.

⚠️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 SPO2 is a wireless pulse oximeter system for screening, diagnosing or monitoring acute respiratory or heart illness. System is intended for acquiring, viewing and storing measurements from adult and paediatric patients. It is a wireless system which is comprised of wireless medical tablet system, pulse oximeter diagnostic module and a 4-port charging station module.

MESI mTABLET SPO2 is intended to be used solely in a professional clinical environment by trained healthcare personnel which understand the principle of oximetry and able to place the sensor on the patient body.

MESI mTABLET SPO2 is intended to measure functional oxygen saturation of haemoglobin in arterial blood by measuring differential absorption of infrared and red light by oxygenated and deoxygenated haemoglobin. This is captured and displayed as a numerical and graphical representation on MESI mTABLET UNIT.

With the standard software, the MESI mTABLET SPO2 displays simultaneously oxygen saturation and heart rate. PRODUCT DESCRIPTION 9 The device is recharged through AC/DC power supply; however, the device is not intended to be used while connected to mains electricity.

Technical specifications

Following are the technical information regarding the MESI SPO2 MODULE, its measurement and FingerClip Sensor (CS10299) provided within the package.

3.1 MESI PULSE OXIMETER UNIT

3.1.1 DIMENSIONS

Width: 40 mm (1.57 inches)

Depth: 48 mm (1.89 inches)

Height: 135 mm (5.31 inches)

Weight: 210 g

3.1.2 POWER & BATTERY

3.1.3 CLASSIFICATION

3.1.4 OPERATING CONDITIONS

NOTE: The device is protected against the ingress of a solid object greater than 1 mm in size as well as against the harmful effects of spraying water from all sides.

⚠️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. 

3.1.5 MEASUREMENT SPECIFICATIONS

NOTE: SPO2MD is calibrated to display functional oxygen saturation.

NOTE: For compliance with ISO 80601-2-61 the temperature has been measured on each SpO2 sensor with thermocouples (Type K ≤ 0,25 mm wire) procedure. During the measurement, a functional tester FLUKE ProSim 8 with artificial finger setting was used.

Alerts are implemented in MESI mTABLET UNIT and are being used for monitoring oxygen saturation and pulse rate value. It is not intended to be used for monitoring vital signs of the patient.

3.1.6 CONNECTIVITY

Data connectivity with MTABMD (Bluetooth 2.1 + EDR)

3.2 SpO₂ SENSORS

The SPO2MD is compatible with the following SpO₂ sensors:

• FingerClip 1.2 m (CS10299)

• FingerClip 2.5 m (CS10299-02)

• EarClip sensor (CS10109)

• SoftTip® Medium (CS10318)

• SoftTip® Large (CS10319)

• Wrap-Sensor (CS10329)

• Y-Sensor (CS10532)

The SPO2MD package includes adult FingerClip Sensor (CS10299) for SpO₂ measurement.

Provided sensor:

SpO₂ FingerClip Sensor (CS10299)

Accuracy:

The accuracy for the approved sensor according to this standard is given as the root-mean-square difference (Arms) between the measured SpO₂ values and reference SaO₂ values. SpO₂ FingerClip (CS10299): 2,3 % (Arms)

Length of the sensor:

SpO₂ FingerClip Sensor (CS10299): 120 cm

Wavelength and Output Power:

RED: 660 nm at 3,5 – 4,5 mW

IR: 905 nm at 3,5 – 4,5 mW

This information is especially useful for clinicians performing photodynamic therapy.

NOTE: For more information regarding approved sensors and other accessories see instruction manual of the sensor available in the MESI package or contact your local distributor.

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 SPO2. For detailed description of individual functions of the device, see chapter 5.3.1 STEP-BY-STEP SPO₂ MEASUREMENT.

⚠️The MESI mTABLET SPO2 is not intended for continuous monitoring.

4.1 PREPARATION FOR MEASUREMENT

⚠️MESI SPO2 MODULE is part of the MESI mTABLET SPO2 system. Before starting a measurement be sure that you are familiar with all devices and their instructions which are part of the system. MESI mTABLET SPO2 is comprised out of MESI mTABLET (MTABSYSW), MESI SPO2 MODULE (SPO2SYS) and MESI LARGE CHARGING PLATE (CS4SYS).

4.1.1 PAIRING WITH A MESI mTABLET UNIT

Before any measurements can be performed the MESI PULSE OXIMETER UNIT module needs to be paired to the MESI mTABLET UNIT. For detailed instructions please follow instructions in chapter 5.1.5 PAIRING.

4.1.2 CONNECTING THE SENSOR

FingerClip Sensor (CS10299) is disconnected during storage and transportation. Before first use connect the sensor to the port on the MESI PULSE OXIMETER UNIT. Ensure that the sensor is securely connected.

NOTE: MESI SPO2 MODULE comes with a FingerClip Sensor (CS10299), used for measuring SpO₂ on the finger. For instructions on other types of sensors please observe the manual supplied with the sensor package.

4.1.3 PATIENT PREPARATION

Step 1 Select the appropriate SpO₂ sensor

Select the required SpO₂ sensor depending on the patient’s category, weight and application site.

Step 2 Applying the SpO₂ sensor to the patient

Clean the application site, remove barriers (coloured nail polish, dried blood etc.) and apply the senor to the patient.

NOTE: Observe instructions for use that are provided with the pulse oximeter sensor

4.1.4 PERFORMING SpO₂ 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

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

Step 3

Apply the SpO₂ sensor to the correct application site.

NOTE: For additional information see MESI mTABLET instruction manual – chapter PATIENT MANAGEMENT.

Step 4

The measuring screen displays oxygen saturation level (%), heart rate (bpm) and other settings. After selecting the patient, select the SpO₂ measurement in the application menu. After about 30s press DONE button on the bottom of the screen. MESI SPO2 MODULE provides a fast and accurate snapshot of the patient’s SpO₂ and heart rate.

4.2 RESULTS

After the measurement is complete the system will automatically switch to the result page where additional parameters of signal can be viewed by scrolling up and down. Top menu navigation provides basic actions such as:

NOTE: For more information about the result screen see chapter 5.4 REVIEWING SpO₂ 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 SPO2 MODULE package contains wireless MESI PULSE OXIMETER UNIT and FingerClip Sensor (CS10299). Before first use, the device needs to be paired with MESI mTABLET UNIT. Follow the instructions carefully.

5.1.2 ACTIVATION

When setting up the MESI SPO2 MODULE 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, 5.1.2 ACTIVATION before initial use, the MESI SPO2 MODULE is fully charged.

5.1.3 TURNING ON THE MESI PULSE OXIMETER UNIT

MESI PULSE OXIMETER UNIT comes with an internal battery. Press the button on top of the MESI PULSE OXIMETER UNIT. If the green light f lashes, the module is ready for the next step. For more information on battery charging see the chapter 6.1 CHARGING THE BATTERY.

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 AC/DC POWER SUPPLY AND BATTERY

The MESI PULSE OXIMETER 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 orange. Only when the device is completely charged it will start flashing green. For more information see chapter 5.5 MULTIFUNCTIONAL LED BUTTON.

5.1.5 PAIRING

Before any measurements can be performed the MESI PULSE OXIMETER UNIT needs to be paired to 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 the MESI PULSE OXIMETER UNIT.

Step 3

When the MESI mTABLET UNIT establishes a connection with MESI PULSE OXIMETER UNIT, the light on top of the module will change. Confirm the pairing process by pressing the button on top of the module again.

Step 4

Final screen indicates successful connection between the MESI mTABLET UNIT and the MESI PULSE OXIMETER UNIT. It is possible to access additional information about the connected modules in User profile >Settings > Modules > Connected modules

NOTE: While operating only with one MESI mTABLET UNIT, then 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.

5.1.6 CONNECTING PATIENT CABLE

Before first use, during transportation and when storing for longer periods, the sensor should be disconnected from the MESI PULSE OXIMETER UNIT. To connect the FingerClip Sensor (CS10299), follow the next steps:

Step 1

Hold resting MESI PULSE OXIMETER UNIT and the FingerClip Sensor cable (CS10299) in your hands firmly.

Step 2

Connect the FingerClip Sensor (CS10299) to the MESI PULSE OXIMETER UNIT as shown below.

5.2 PATIENT SELECTION

Before performing a measurement, patient needs to be selected or added to your working groups 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 SpO₂ MEASUREMENT

Standard accessories include FingerClip Sensor (CS10299).

1. Before first measurement it is advised for the patient to wash hands. This will reduce transmission of microorganisms and body secretions.

2. Remove anything on the site of application that absorbs light (such as dried blood or nail polish).

3. Warm the area where the FingerClip Sensor (CS10299) will be attached.

4. Clear out any sources of environmental interference (high levels of light).

5. Attach the FingerClip Sensor (CS10299) to the finger (usually middle or index finger) and try to minimize movement.

NOTE: For other sensors observe Instructions for use of the sensor available in the MESI package or contact your local distributor for more information.

5.3.1 STEP-BYSTEP SpO₂ MEASUREMENT

Step 1

On the MESI mTABLET UNIT select existing patient or add a new one. For additional information see chapter 5.2 PATIENT SELECTION.

Step 2

After selecting the patient, select the SpO₂ application in application menu.

Step 3

Apply the SpO₂ sensor on appropriate location and press START button.

NOTE: If MESI PULSE OXIMETER UNIT has low battery or connectivity issues notifications will be displayed on instructions screen. In case of errors advise the chapters 8 ERRORS and 9 TROUBLESHOOTING.

Step 4

The measuring screen displays oxygen saturation level (%) and pulse rate (SpO₂).

Step 5

After about 30 s or when the SpO₂ values stabilize press DONE button on the bottom of the screen to record the current SpO₂ and heart rate values.

NOTE: The measurement of oxygen saturation can be affected by the following factors: ambient light, nail polish, skin pigment, damaged sensor, improper placement of sensor and muscle tremor.

NOTE: Poor peripheral perfusion or cold fingers can cause low perfusion, or blood f low, which can lead the oximeter to make an inaccurate reading. The application site can be warmed before measurement or the sensor should be repositioned.

5.3.2 ADITIONAL SETTINGS

During the SpO₂ measurement there are Additional settings and alerts, which can be changed:

• The area of minimum and maximum saturation alert. After change this can be saved as a default values.

• Alert volume – set the volume alert by sliding or tapping left/ right on the slide bar.

• Pulse bar volume – set the pulse bar volume by sliding or tapping left/right on the slide bar.

• Device volume – set the device volume by sliding or tapping left/right on the slide bar.

5.4 REVIEWING SpO₂ MEASUREMENT

5.4.1 MESI MTABLET RESULTS SCREEN

When the measurement process is completed, result will be displayed on the screen. It consists of five different areas: navigation area, numeric result of SpO₂ and HR, patient’s measurements history, comments on the result, and another navigation area.

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

The SpO₂ and pulse rate measurement can be viewed immediately on the MESI mTABLET UNIT for further analysis. With standard software the MESI PULSE OXIMETER UNIT is used for spot-checking of patients during no-motion conditions.

5.4.1.3 Patient measurement history

History holds an overview of measurements done by the same doctor on the same patient. It shows the trend of the patient’s results.

5.4.1.4 Comments area

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

5.5 MULTIFUNCTIONAL LED BUTTON

Even though most of the MESI PULSE OXIMETER UNIT control is done 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 PULSE OXIMETER UNIT.

5.5.1 LED INDICATORS

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

5.5.2.2 Measurement mode

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 sufficient for approximately 8000 measurements or 56 hours of continuous use.

To charge the battery, place the MESI PULSE OXIMETER UNIT on the MESI LARGE CHARGING PLATE UNIT. During the charging process the light on the module will be flashing orange. 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.

Reusable pulse oximetry sensors

The pulse oximeter sensor must be carefully cleaned and disinfected after every use and before use with a different patient. The sensor can be reused on the same patient, for the patient’s entire stay. If the sensor is covered with dust and dirt, it can affect the performance of the device. Observe the cleaning instructions in the Instructions for Use that came with the sensor.

⚠️Do not use aggressive cleaning agents, volatile liquids or excessive force when cleaning the device. Don’t dip the sensor in liquids or cleaning agents.

MESI PULSE OXIMETER UNIT

• Before cleaning remove the MESI PULSE OXIMETER UNIT from the charging station and disconnect the sensor from the MESI PULSE OXIMETER UNIT.

• Use a soft lint-free cloth dampened with a proper cleaning agent to clean and disinfect the exterior and interior of the unit/sensor.

• 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)

Not approved cleaning agents:

• Organic solvents

• Ammonia-based detergent

• Abrasive cleaning agents

• 100% alcohol, acetone, chlorine etc.

6.3 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 device and accessories,

• performance of device in accordance to instructions for use,

• legibility of labels,

• battery cycle count.

General warnings

7.1 MEASUREMENT PROCEDURE

⚠️This product is not designed for sterile use.

⚠️Do not use this unit in areas where there in the presence of flammable gases such as anaesthetic agents or in an oxygen-rich environment.

⚠️Do not place the sensor on wounds, as this may cause additional injury.

7.2 MAINTENANCE

⚠️Before cleaning disconnect from the mains. Due to constant standby mode of the device do not clean terminals. 

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

⚠️Do not use high-temperature sterilization processes (such as autoclaving). Do not use e-beam or gamma radiation sterilization.

⚠️Do not dispose of 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). 

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

7.3 FUNCTIONING OF THE DEVICE

⚠️Regularly inspect sensor and cable for any signs of damage. Do not use damaged sensor as the accuracy cannot be assured.

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

⚠️To prevent electric shock or damage to the device do not disassemble the unit. The device does not contain any parts which can be replaced or serviced by a user. If a defect occurs, consult your dealer or distributor.

⚠️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. 

⚠️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 MESI mTABLET SPO2 including cables specified by the manufacturer. Otherwise the degradation of the performance of this equipment could result.

⚠️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.

⚠️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.

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 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.

11.1. MANUFACTURER DECLARATION ON EMC

MESI mTABLET SPO2 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 SPO2 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 SPO2 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

MESI mTABLET SPO2 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

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 SPO2 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.

Guidance and manufacturer’s declaration - electromagnetic immunity

MESI mTABLET SPO2 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.

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 SPO2 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

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.

11.2 ESSENTIAL PERFORMANCE

Essential performance of MESI mTABLET SPO2 is measuring oxygen saturation of haemoglobin in arterial blood and pulse rate in beats per minute.

Due to the devices high sensitivity, intended use and operating modes the device is susceptible to EM interferences and should be used only in operating conditions specified in this instructions for use.

In case of errors in SpO₂ or HR measurement higher than defined in instructions for use due to EM interferences, the device presents an unacceptable risk and will warn the user of its inoperability.

Important labels

09-2021 / V. 1.4