SBM 37 - Blood pressure monitor SANITAS - Free user manual and instructions

USER MANUAL SBM 37 SANITAS

1. Getting to know your device

Check that the packaging of the Sanitas SBM 37 blood pres- sure monitor has not been tampered with and make sure that the required contents are present. Before use, ensure that there is no visible damage to the device or accessories and that all packaging material has been removed. If you have any doubts, do not use the device and contact your retailer or the specified Customer Services address. The upper arm blood pressure monitor is used to carry out non-invasive measurement and monitoring of the arterial blood pressure values in adults. This allows you to quickly and easily measure your blood pres- sure, save the measured values and display the development and average values of the measured values taken. You are also warned of possible existing cardiac arrhythmia. The recorded values are classified and evaluated graphically. Store these instructions for use for future reference and make them accessible to other users.

Signs and symbols The following symbols are used in these instructions for use, on the packaging and on the type plate for the device and the accessories: Attention Note Note on important information Observe the instructions for use Application part, type BF Direct current Disposal in accordance with the Waste Elec- trical and Electronic Equipment EC Directive – WEEE Manufacturer18 Storage RH ≤93% -25°C 70°C Permissible storage temperature and humi- dity Operating 5°C 40°C RH 15-93% Permissible operating temperature and humidity Protect from moisture SN Serial number The CE labelling certifies that the product complies with the essential requirements of Directive 93/42/EEC on medical products. Notes on use

In order to ensure comparable values, always measure your blood pressure at the same time of day.

Before every measurement, relax for about five minutes.

If you want to perform several measurements on the same person, wait five minutes between each measurement.

Do not take a measurement within 30 minutes of eating, drin- king, smoking or exercising.

Repeat the measurement if you are unsure of the measured value.

The measured values taken by you are for your information only – they are no substitute for a medical examination. Dis- cuss the measured values with your doctor and never base any medical decisions on them (e.g. medicines and their administration).

Do not use the blood pressure monitor on newborns or pati- ents with preeclampsia. We recommend consulting a doctor before using the blood pressure monitor during pregnancy.

Cardiovascular diseases may lead to incorrect measure- ments or have a detrimental effect on measurement accura- cy. The same also applies to very low blood pressure, diabe- tes, circulatory disorders and arrhythmias as well as chills or shaking.

The blood pressure monitor must not be used in connection with a high-frequency surgical unit.

Only use the device on people who have the specified upper arm measurement for the device.

Please note that when inflating, the functions of the limb in question may be impaired.

During the blood pressure measurement, the blood circulati- on must not be stopped for an unnecessarily long time. If the device malfunctions remove the cuff from the arm.

Avoid any mechanical restriction, compression or bending of the cuff line.

Do not allow sustained pressure in the cuff or frequent measurements. The resulting restriction of the blood flow may cause injury.

Make sure that the cuff is not placed on an arm in which the ar- teries or veins are undergoing medical treatment, e.g. intravas- cular access or intravascular therapy, or an arteriovenous (AV) shunt.

Do not use the cuff on people who have undergone a mas- tectomy.19

Do not place the cuff over wounds as this may cause further injury.

Please note that data transfer and data storage is only pos- sible when your blood pressure monitor is supplied with po- wer. As soon as the batteries are empty, the blood pressure monitor loses the date and time.

To conserve the batteries, the blood pressure monitor swit- ches off automatically if no buttons are pressed for 30se- conds.

The device is only intended for the purpose described in these instructions for use. The manufacturer is not liable for damage resulting from improper or careless use. Instructions for storage and maintenance

The blood pressure monitor is made from precision and elec- tronic components. The accuracy of the measured values and service life of the device depend on its careful handling:

– Protect the device from impacts, humidity, dirt, marked temperature fluctuations and direct sunlight. – Do not drop the device. – Do not use the device in the vicinity of strong electroma- gnetic fields and keep it away from radio systems or mobile telephones.

Only use the cuff included with the delivery or original re- placement parts. Otherwise incorrect measured values will be recorded.

Do not press the buttons before the cuff is placed on the arm. Notes on handling batteries

• If your skin or eyes come into contact with battery fluid, rinse the affected areas with water and seek medical assistance.

• Choking hazard! Small children may swallow and choke on batteries. Store the batteries out of the reach of small child- ren.

• Observe the plus (+) and minus (-) polarity signs.

• If a battery has leaked, put on protective gloves and clean the battery compartment with a dry cloth.

• Protect batteries from excessive heat.

• Risk of explosion! Never throw batteries into a fire.

• Do not charge or short-circuit batteries.

• If the device is not to be used for a relatively long period, take the batteries out of the battery compartment.

• Use identical or equivalent battery types only.

• Always replace all batteries at the same time.

• Do not use rechargeable batteries.

• Do not disassemble, open or crush the batteries. Battery disposal

The empty, completely discharged batteries must be disposed of through specially designated collection boxes, recycling points or electronics retailers. You are legally required to dis- pose of the batteries.

• The codes below are printed on batteries containing harmful substances: Pb = Battery contains lead, Cd = Battery contains cadmium, Hg = Battery contains mercury20 Instructions for repairs and disposal

• Batteries do not belong in household waste. Please dispose of empty batteries at the collection points intended for this purpose.

Do not repair or adjust the device yourself. Proper operation can no longer be guaranteed in this case.

Repairs must only be carried out by Customer Services or authorised suppliers.

Do not open the device. Failure to comply will invalidate the warranty.

For environmental reasons, do not dispose of the device in the household waste at the end of its useful life. Dispose of the device at a suitable local collection or recycling point. Dispose of the device in accordance with EC Directive – WEEE (Waste Electrical and Electronic Equip- ment). If you have any questions, please contact the local authorities responsible for waste disposal.

7. Scale for classifying the measurements

8. Connection for cuff connector (left-hand side)21

3. Diastolic pressure

8. Classification of measurements

12. Symbol for Bluetooth

transfer System requirements for the HealthCoach app Bluetooth

devices from Version 4.3 with Bluetooth

Smart Ready List of compatible devices:

4. Preparing the measurement

Remove the battery compartment lid on the rear of the device.

Insert four 1.5V AAA (alkaline type LR03) batteries. Make sure that the batteries are inserted the correct way round. Do not use rechargeable batteries.

Close the battery compartment lid again carefully. All display elements are briefly displayed, or flashes in the display. Now set the date and time as described below. If the battery replacement symbol is permanently displayed, you can no longer perform any measurements and must replace all batteries. Once the batteries have been remo- ved from the device, the date and time must be set again. Any saved measured values are retained. 4 x 1,5 V AAA22 Set the hour format, date, time and Bluetooth ® settings The following section describes the functions and settings available on the blood pressure monitor. Hour format

It is essential to set the correct date and time. Otherwise, you will not be able to save your measured values correctly with a date and time and access them again later. If you press and hold the M1 or M2 memory button, you can set the values more quickly. Press and hold the START/STOP button for 5 seconds. Hour format The hour format now flashes on the display.

Select the desired hour format using the M1/M2 memory buttons and confirm with the START/STOP button . Date The year flashes on the display.

Select the current day using the M1/M2 memory buttons and confirm with the START/STOP button . If you have set the 12h hour format, the month is displayed before the day. Time The hours flash on the display.

Select the current hours using the M1/ M2 memory buttons and confirm with the START/STOP button . The minutes flash on the display.

Select the current minutes using the M1/ M2 memory buttons and confirm with the START/STOP button .23 Bluetooth

symbol flashes on the display.

data transfer is activated (Blue- tooth

symbol flashes) or deactivated (Bluetooth

symbol is not shown) and confirm with the START/ STOP button . Bluetooth

transfers will reduce the battery life.

5. Measuring blood pressure

Ensure the device is at room temperature before measuring. The measurement can be performed on the left or right arm. Attaching the cuff Place the cuff on to the bare left upper arm. The circulation of the arm must not be hindered by tight clothing or similar. The cuff must be placed on the upper arm so that the bottom edge is positioned 2 – 3 cm above the elbow and over the artery. The line should point to the centre of the palm. Now tighten the free end of the cuff, but make sure that it is not too tight around the arm and close the hook- and-loop fastener. The cuff should be fastened so that two fingers fit under the cuff. Now insert the cuff line into the connection for the cuff connector. If the measurement is performed on the right upper arm, the line should be located on the inside of your elbow. En- sure that your arm is not pressing on the line. Blood pressure may vary between the right and left arm, which may mean that the measured blood pressure values are diffe- rent. Always perform the measurement on the same arm. If the values between the two arms are significantly different, please consult your doctor to determine which arm should be used for the measurement. Important: The unit may only be operated with the original cuff. The cuff is suitable for an arm circumference of 22 to 36cm. A larger cuff for upper-arm circumferences of 35 to 44 cm can be obtained from specialist retailers or from the service address using order number 163.387.

Before every measurement, relax for about five minutes. Otherwise deviations can occur.

You can take the measurement while sitting or lying down. Always make sure that the cuff is at heart level.

To carry out a blood pressure measurement, make sure you are sitting comfortably with your arms and back leaning on something. Do not cross your legs. Place your feet flat on the ground.

To avoid falsifying the measurement, it is important to remain still during the measurement and not to speak. Performing the blood pressure measurement Measurement As described above, attach the cuff and adopt the po- sture in which you want to perform the measurement.

Press the START/STOP button to start the blood pressure monitor. All display elements are briefly displayed. The blood pressure monitor will begin the measurement automatically after 3 se- conds. You can cancel the measurement at any time by pressing the START/STOP button . As soon as a pulse is found, the pulse symbol will be displayed.

The systolic pressure, diastolic pressure and pulse rate measurements are displa- yed.

appears if the measurement could not be performed properly (see chapter 9 "Er- ror messages/troubleshooting"). Repeat the measurement.25 Measurement

Now select the desired user memory by pressing the M1 or M2 memory buttons. If you do not select a user memory, the measurement is stored in the most re- cently used user memory. The relevant or symbol appears on the display.

Press the START/STOP button to switch off the blood pressure monitor. The measurement is then sto- red in the selected user memory.

If the device is not switched off manually, it will switch off automatically after 3 minutes. If Bluetooth® data transfer has been activated, data is by transferred after having confirmed the user memory by pressing the pressing the START/STOP button

symbol on the display flashes and the blue LED lights up. The blood pressure monitor now attempts to connect to the app for approx. 30 seconds.

symbol stops flashing as soon as a connection is established. All measurement data is automatically transferred to the app. Once the data has been successfully transferred, the device switches off. If the data transfer was unsuccessful, the blue LED goes out and " " appears on the display.

• If a connection to the app cannot be established after 30 seconds, the Bluetooth

symbol goes out and the blood pressure monitor switches off automatically after 3 minutes. Measurement Please note that you must add the blood pressure monitor in "My devices" in the "HealthCoach" app to enable data transfers. The "HealthCoach" app must be active to allow data transfer. If the latest data is not displayed on your smart- phone, repeat the data transfer as described in

If you forget to turn off the blood pressure monitor, it will switch off automatically after approximately 3 minutes. In this case too, the value is stored in the selected or most recent user memory and the data is transferred if Blue- tooth

data transfer has been activated.

Wait at least 5 minutes before taking ano- ther measurement.

6. Evaluating results

Cardiac arrhythmia: This device can identify potential disruptions of the heart rhythm when measuring and if necessary, indicates this after the measurement with the symbol

This can be an indicator for arrhythmia. Arrhythmia is a condi- tion in which the heart rhythm is abnormal because of flaws in the bioelectrical system that regulates the heartbeat. The sym- ptoms (skipped or premature heart beats, pulse being slow or too fast) can be caused by factors such as heart disease, age, physical make-up, excess stimulants, stress or lack of sleep.26 Arrhythmia can only be determined through an examination by your doctor. If the symbol is shown on the display after the measure- ment has been taken, repeat the measurement. Please ensure that you rest for 5 minutes beforehand and do not speak or move during the measurement. If the symbol appears frequently, please consult your doctor. Self-diagnosis and treatment based on the measurements can be dangerous. Always follow your GP’s instructions. Classification of measurements: The measurements can be classified and evaluated in accor- dance with the following table. However, these standard values serve only as a general guideline, as the individual blood pressure varies in different people and different age groups etc. It is important to consult your doctor regularly for advice. Your doctor will tell you your individual values for normal blood pressure as well as the value above which your blood pressure is classified as dangerous. The classification on the display and the scale on the unit show which category the recorded blood pressure values fall into. If the values of systole and diastole fall into two different cate- gories (e.g. systole in the ‚High normal‘ category and diastole in the ‚Normal‘ category), the graphical classification on the de- vice always shows the higher category; for the example given this would be ‚High normal‘. Blood pressure value category Systole (in mmHg) Diastole (in mmHg) Action Setting 3: severe hyper- tension ≥ 180 ≥ 110 seek medical at- tention Setting 2: moderate hyper- tension 160 – 179 100 – 109 seek medical at- tention Setting 1: mild hyperten- sion 140 – 159 90 – 99 regular monitoring by doctor High normal 130 – 139 85 – 89 regular monitoring by doctor Normal 120 – 129 80 – 84 self-monitoring Optimal < 120 < 80 self-monitoring Source: WHO, 1999 (World Health Organization)27

7. Display and delete measured values

User memory The results of every successful measurement are stored together with the date and time. The oldest measurement is overwritten in the event of more than 60 measure- ments.

Select the desired user memory ( ) with the M1 or M2 memory buttons if the device is switched off.

To view the measurement data for user memory , press the M1 memory button.

To view the measurement data for user memory , press the M2 memory button. The average of all measurements appears on the display. If Bluetooth

is activated (the symbol flashes on the display), the blood pressure monitor attempts to connect to the app. If you press the M1 button in the meantime, the transfer is cancelled and the average values are displayed. If you press the M2 button, the transfer is cancelled and the measurement data of user memory is displayed. The symbol is no longer shown. The buttons are deactivated as soon as a connection is established and the data is transferred. Average values Press the M1 button if you have selected user memory 1. Press the M2 memory button if you have selected user memory2.

flashes on the display. The average value of all saved measured values in this user memory is displayed.

flashes on the display. The average value of the morning measure- ments for the last 7 days is displayed (mor- ning: 5.00 a.m. – 9.00 a.m.).

flashes on the display. The average value of the evening measure- ments for the last 7 days is displayed (eve- ning: 6.00 p.m. – 8.00 p.m.).28 Individual measured values

hen the relevant memory button (M1 or M2) is pressed again, the last individual measurement is displayed (in this example, measurement 03).

hen the relevant memory button (M1 or M2) is pressed again, you can view your individual measurements.

To switch the device off again, press the START/STOP button . You can exit the menu at any time by pressing the START/STOP button . Delete the measured values

To clear the memory of the relevant user memory, you must first select a user memory.

Start the retrieval of the average measured values. A flashes on the display and the average value of all saved measured values in this user memory is dis- played.

Press and hold the memory button M1 or M2 for 5 seconds depending on the user memory you are in. All the values in the current user memory are deleted. Deleting individual measurements

o clear individual measurements from the relevant user memory, you must first select a user memory.

Start the retrieval of the individual measured values.

Press and hold the memory button M1 or M2 for 5 seconds (depending on the user memory you are in).

The selected value is deleted. The device briefly dis- plays CL 00.

If you would like to delete other values, repeat the pro- cess described above. You can switch off the device at any time by pressing the START/STOP button. Transfer via Bluetooth

Smart It is also possible to transfer the measured values saved on the device to your smartphone using Bluetooth

Smart. You will need the HealthCoach app for this. The app is availa- ble from the App Store. Proceed as follows to transfer values: If Bluetooth

is activated in the settings menu, the data is transferred automatically after the measurement. The symbol appears in the top left of the display (see chapter 4 „Preparing the measurement“).29 Step 1: SBM 37 Activate Bluetooth

on your device (see chap- ter 4 "Preparing the measurement“, Bluetooth

Step 2: "HealthCoach" app In the HealthCoach app, add the SBM 37 under "Settings/My devices". Step 3: SBM 37 take a measurement. Step 4: SBM 37 data transfer immediately following measurements.

If Bluetooth® data trans- fer has been activated, data is by transferred after having confirmed the user memory by pressing the pressing the START/STOP button . Step 4: SBM 37 Data transfer at a later point:

Go to memory mode (chapter 7). Select the desired user memory. The Bluetooth

transfer starts automatically. The HealthCoach app must be active to allow data transfer. If your smartphone has a protective cover, remove this to ensu- re that there is no interference during the transfer. Begin the data transfer in the HealthCoach app.

8. Cleaning and storing the unit

Clean the device and cuff carefully using a slightly damp cloth only.

Do not use any cleaning agents or solvents.

Under no circumstances should you hold the unit under wa- ter, as this can cause liquid to enter and damage the unit.

If you store the device, no heavy objects should be placed on top of it. The cuff line should not be bent sharply. In such cases, repeat the measurement and/or data transfer. Ensure that the cuff line is correctly attached and that you do not move or speak during the measurement.

appears on the display. Error messages may appear if:

• it was not possible to record the pulse:

• you move or speak during the measurement:

• the cuff is fastened too tightly or loosely:

• errors occur during the measurement:

• the pump pressure is higher than 300 mmHg:

• the batteries are almost empty :

• the data could not be sent via Bluetooth

and accompanying logo are regi- stered trademarks of Bluetooth

SIG, Inc. Any and all use of these marks by Hans Dinslage GmbH is done so under licence. Other trademarks and trade names are the property of the relevant holder.

10. Technical specifications

Model No. SBM 37 Measurement me- thod Oscillometric, non-invasive blood pres- sure measurement on the upper arm Measurement range Cuff pressure 0 – 250mmHg, Systolic 50 – 250mmHg, Diastolic 30 – 200mmHg, Pulse 40 – 180 beats/minute Display accuracy Systolic ± 3 mmHg, Diastolic ± 3 mmHg, Pulse ± 5 % of the value shown Measurement inac- curacy Max. permissible standard deviation according to clinical testing: Systolic 8 mmHg / Diastolic 8 mmHg Memory 2 x 60 memory spaces Dimensions L 139 mm x W 94 mm x H 48 mm Weight 236 (without cuff) Cuff size 22 to 36 cm Permissible operating conditions + 5°C to + 40°C, 15-93% relative humi- dity (non-condensing) Permissible storage conditions -25°C to + 70°C, ≤ 93% relative humidity, 800 – 1050 hPa ambient pressure Power supply 4x 1.5V AAA batteries Battery life Lasts for approx. 200 measurements depending on the blood pressure and pump pressure as well as the number of Bluetooth

connections. Accessories Cuff, instructions for use, storage pouch Classification Internal supply, IPX0, no AP or APG, continuous operation, application part type BF Data transfer via Bluetooth® wireless technology The blood pressure monitor uses Blu- etooth® Smart (low energy), 2.4GHz frequency band, compatible with Blue- tooth 4.0 smartphones/tablets List of supported smartphones/tablets Technical information is subject to change without notification to allow for updates.

This device complies with European Standard EN60601- 1-2 and is subject to particular precautions with regard to electromagnetic compatibility. Please note that portable and31 mobile HF communication systems may interfere with this unit. More details can be requested from the stated Custom- er Services address or found at the end of the instructions for use.

The device complies with the EU Medical Devices Directive 93/42/EC, the German Medical Devices Act (Medizinproduk- tgesetz) and the standards EN1060-1 (non-invasive sphyg- momanometers – Part1: General requirements), EN1060-3 (non-invasive sphygmomanometers – Part 3: Supplementary requirements for electro-mechanical blood pressure measur- ing systems) and IEC80601-2-30 (Medical electrical equip- ment – Part 2 – 30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers).

The accuracy of this blood pressure monitor has been care- fully checked and developed with regard to a long useful life. If using the device for commercial medical purposes, it must be regularly tested for accuracy by appropriate means. Precise instructions for checking accuracy may be requested from the service address.

±6 kV contact ±8 kV air ±6 kV contact ±8 kV air Floors should be wood, concrete or ceramic tile. If floor are covered with synthetic material, the relative humidity should be at least 30%.80 Power frequency (50Hz) magnetic field

3A/m 3A/m Power frequency magnetic fields should be at levels characte- ristic of a typical location in a typical commercial or hospital environment. Guidance and manufacturer’s declaration – electromagnetic immunity for EQUIPMENT and SYSTEMS that are not LIFE- SUPPORTING The Blood pressure monitor (SBM 37) is intended for use in the electromagnetic environment specified below. The customer or the user of Blood pressure monitor (SBM 37) should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance Portable and mobile RF communications equipment should be used no closer to any part of the Blood pressure monitor (SBM 37), inclu- ding cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance. Conducted RF

3 V rms 150 kHz to 80 MHz 3 V rms Radiated RF

3 V/m 80 MHz to 800 MHz 800 MHz to 2.5 GHz81 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 metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb. 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 re- flection from structures, objects and people.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and 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 con- sidered. If the measured field strength in the location in which the Blood pressure monitor (SBM 37) is used exceeds the applicable RF compliance level above, the Blood pressure monitor (SBM 37) should be observed to verify normal opera- tion. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Blood pressure monitor (SBM 37).

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.82 Recommended separation distances Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM – for EQUIPMENT or SYSTEM that are not LIFESUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the Blood pressure moni- tor (SBM 37). The Blood pressure monitor (SBM 37) is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Blood pressure monitor (SBM 37) can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Blood pres- sure monitor (SBM 37) as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter (W) Separation distance according to frequency of transmitter (m) 80 MHz to 800 MHz 800 MHz to 2.5 GHz 0,01 0.1167 0.2334 0,1 0.3689 0.7378

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated 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 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.8384 757.807-0815 Irrtum und Änderungen vorbehalten