SL 100 Connect - Blood pressure monitor MEDISANA - Free user manual and instructions

USER MANUAL SL 100 Connect MEDISANA

1 Safety Information 2 Useful Information 3 Getting started 4 Operating 5 Memory 6 Miscellaneous 7 Warranty

Device and controlsDE

7 Garantie 15This instruction manual belongs to this device. It contains important information about starting up and operation. Read the instruction manual thoroughly. Non-observance of these instruc- tions can result in serious injury or damage to the device. WARNING These warning notes must be observed to prevent any injury to the user. CAUTION These notes must be observed to prevent any damage to the device. NOTE These notes give you useful additional information on the installation or operation. Explanation of symbols Lot number Manufacturer IMPORTANT INFORMATION! RETAIN FOR FUTURE USE! Read the instruction manual carefully before using this device, especially the safety instructions, and keep the instruction manual for future use. Should you give this device to another person, it is vital that you also pass on these instructions for use. Classification: Type BF applied part Date of manufacture

1 Safety Information 16INTENDED USE: This fully automatic electronic blood pressure monitor is intended for measuring the blood pressure at home. It is a non-invasive blood pressure measurement system to measure the diastolic and systolic blood pressure and pulse of an adult using a non-invasive technique by means of a cuff, which needs to be fitted on the wrist. The useable cuff circumference is 13,5 to 21,5 cm (about 5 to 8.5 inches). CONTRAINDICATIONS: The device is not suitable for measuring the blood pressure of children. Ask your doctor before using it on older children. The device is not suitable for use on: - pregnant women, - patients with implanted, electrocical devices, - patients with pre-elcampsia, premature ventricu- lar beats, atrial fibrillation, peripheral, arterial disease, - patients undergoing intravascular therapy or arterio-venous shunt or people who received a mastectomy. Please consult your doctor prior to using the unit if you suffer from illnesses

Safety Information WARNING! Do not take any therapeutic measures on the basis of a self measurement. Never alter the dose of a medicine prescribed by a doctor.

1 Safety Information 17The unit is intended only for use in private homes. i Consult your doctor prior to using the blood pressure moni- tor if you are concerned about health matters. i Only use the unit for its intended purpose in accordance with the instruction manual. i Warranty claims become void if the unit is misused. i The unit may not be used to check the heart rate of a pace- maker. i Do not use the unit in case of existing polyester resp. syn- thetic allergies. i Never apply the cuff over hurt skin. i Do not take measurements, if any other equipment is applied to the same limb for monitoring. This could lead to disturbances or failures. i If you experience discomfort during a measurement, such as pain in the wrist or other complaints, press the START / STOP button to release the air immediately from the cuff. Loosen the cuff and remove it from your wrist. i On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, open the cuff immediate- ly. Prolonged high pressure (cuff pressure >300 mmHg or constant pressure >15 mmHg for more than 3 minutes) ap- plied to the arm may lead to an ecchymosis. i Too frequent and consecutive measurements could cause disturbances in blood circulation and injuries. i Pay attention during use and storage, that cables will not cause strangulation. i This device is not suitable for continous monitoring during medical emergencies or operations. i This device is not intended for patient transports outside a healthcare facility. i This device cannot be used with surgical equipment at the same time. i The unit may not be operated in the vicinity of appliances that emit strong electric radiation such as radio transmitters or mobile phones. This may affect the proper functioning (see "electromagnetic compatibility").

1 Safety Information 18Do not use the equipment where flammable gas (such as anaesthetic gas, oxygen or hydrogen) are present. i This device is not designed to be used by persons with limi- ted physical, sensory or mental abilities, or by persons with insufficient experience and/or knowledge, unless under ob- servation by a person responsible for their safety, or unless they have been instructed in the use of the device. i This device is intended to be used by adults. The unit is un- suitable for children or babies. Contact your doctor, if you want to use this device on young persons. i Please ensure that the unit is kept away from the reach of children and pets. The swallowing of small part like pack- aging bag, battery and so on may cause suffocation. i Before use, make sure the device functions safely and is in proper working condition. Do not service or maintain while the device is in use. i Please do not attempt to repair the unit yourself in the event of malfunctions. Only have repairs carried out by authorised service centres. i Protect the unit from moisture. Should moisture enter the unit, stop using it immediately. In this case, please contact either your dealer or us directly. You can find details of how to contact us on the address page. i Only use original additional or spare parts from the manu- facturer. Other parts could damage the device or could lead to personal injury.

1 Safety Information 19Thank you for your confidence in us and congratulations on your pur-chase! You have acquired a quality product with your purchase of the MEDISANA Wrist blood pressure monitor SL 100 connect. To ensure the best results and long-term satisfaction with your MEDISANA Wrist blood pressure monitor SL 100 connect, we recommend that you read the following operating and maintenance instructions carefully. Thank you very much The packaging can be reused or recycled. Please dispose properly of any packaging material no longer required. If you notice any transport damage during unpacking, please contact your supplier without delay. WARNING Please ensure that the polythene packing is kept away from the reach of children! Risk of suffocation!Please check first of all that the device is complete and is not damaged in any way. In case of doubt, do not use it and contact your supplier or your service centre. The following parts are included:

2.1 Items supplied and packaging

1 MEDISANA Wrist blood pressure monitor SL 100 connect1 Mini-USB charging cable1 Storage bag1 Instruction manual and EMC-leaflet

Blood pressure is the pressure created in the blood vessels by each heart beat. When the heart contracts (= systole) and pumps blood into the arteries, it brings about a rise in pressure. The highest value is known as the systolic pressure and is the first value to be measured. When the cardiac muscle relaxes to take in fresh blood, the pressure in the arteries also falls. Once the arteries are relaxed, a second reading is taken – the diastolic pressure.

2.2 What is blood pressure?

The MEDISANA Wrist blood pressure monitor SL 100 connect is a blood pressure device, which is used to measure blood pressure at the wrist. The measurement is carried out by a microprocessor - already during the inflating process of the cuff. The device detects the systole and themeasurement is completed earlier than using conventional measurement methods. As a result, an unnecessarily excessive inflation pressure in the cuff is prevented. Additionally, your device is able to recognize unregular heartbeat (so-called arrhythmia), which may affect the measurements. In case an arrhythmia has been deteced, the respective symbol will appear in the display of the unit (see chapter 4.2 Taking a blood pressure measure-ment).

2.3 How is blood pressure measured?

2 Useful Information 20MEDISANA has had many years of experience in the field of blood pressure measurement. The high precision of MEDISANA devices has been confirmed by extensive clinical tests, carried out according to strict international standards. One strong argument in favour of taking blood pressure at home is the fact that the readings are taken in familiar sur- roundings under relaxed conditions. The most important reading is the so-called „baseline value“, the one taken before breakfast, directly after getting up in the morning. As far as it is possible, you should always try to take your blood pressure at the same time and under the same con- ditions each day. This ensures comparable results and helps in detect- ing the first signs of high blood pressure. If high blood pressure remains undetected, it increases the risk of further cardiovascular diseases.

2.4 Why should you take your blood pressure at home?

THEREFORE WE RECOMMEND: Take a blood pressure reading daily and on a regular basis, even if you are experiencing no apparent complaints. The following table shows the classification of high and low blood pressure, without taking age into consideration. This blood pressure assessment scale corresponds to the guidelines of the World Health Organisation (WHO).

2.5 Blood pressure classification

Blood pressure classification according to WHO guideline ≥ 180 ≥ 110

< 120 < 80 < 100 < 60 serious hypertension medium hypertension mild hypertension high-normal blood pressure normal blood pressure optimal blood pressure low blood pressure WARNING Blood pressure that is too low represents just as great a health risk as blood pressure that is too high! Fits of dizziness may lead to dangerous situations arising (e.g. on stairs or in traffic)!

2 Useful Information 21There are many factors that can influence blood pressure. Readings can be affected seriously by stress, fear, heavy physical exertion or the time of day at which the measurements are taken. Your personal bloodpressure values are subject to considerable fluctuation during the course of the day and the year. These fluctuations are particularly pronounced in the case of patients suffering from hypertension. Blood pressure is usually at its highest during physical exertion and at its lowest at night when you are asleep.

2.6 Fluctuations in blood pressure

Measure your blood pressure several times, then record and compare the results. Do not draw any conclusions from a single reading. iYour blood pressure readings should always be evaluated by a doctor who is also familiar with your personal medical history. When using theunit regularly and recording the values for your doctor, you should visit the doctor from time to time to keep him updated. iWhen taking readings, remember that the daily values are influenced by several factors. Smoking, consumption of alcohol, drugs and phy-sical exertion influence the measured values in various ways. iMeasure your blood pressure before meals. iBefore taking readings, allow yourself at least five minutes rest. iIf the systolic and diastolic readings seem unusual (too high or too low) on several occasions, despite correct use of the unit, please inform your doctor. This also applies to the rare occasions when an irregular or very weak pulse prevents you from taking readings.

2.7 Influencing and evaluating readings

3 Getting started Your MEDISANA Wrist blood pressure monitor SL 100 connect features an integrated rechargeable battery, which enables a cordless operation of your device. Before you can use your unit, the battery should be charged fully. Therefore connect the included mini-USB-cable to the USB interface on the device and to an USB-port of an active electric utility (e.g. PC, laptop computer or mains plug with USB port etc.). i Alternatively, you can charge the device with a special mains adaptor (MEDISANA Art.-No. 51014) via the mini-USB-cable. During the charging process, the display shows e.g. " " with some segments flashing. When charging process is finished (" " is displayed constantly in full without any segments flashing), disconnect the mini-USB-cable from the device. If the "battery low"-symbol appears on the display (together

3.2 Charging the battery

The device has been set to a sleep mode for transportation. This sleep mode has to be unlocked once before first use. Therefore press M - , Start - / Stop - and S - buttons simultaneously. The sleep modefor transportation can only be activated by the factory.

2 Useful Information / 3 Getting started 22GB 3 Getting started

with "Lo") or if nothing appears on the display after the unit has been switched on, you have to recharge the battery in order to ensure further operability. When the battery is fully charged and 3 blood pressure measurements are carried out per day, the energy is sufficient for around 20 days of service.

• Do not disassemble batteries!

• Increased risk of leakage, avoid contact with skin, eyes and mucous membranes! If battery acid comes in contact with any of these parts, rinse the affected area with copious amounts of fresh water and seek medical attention imme- diately!

• If a battery has been swallowed seek medical attention immediately!

• Keep batteries out of children's reach!

• Do not short circuit! There is a danger of explosion!

• Do not throw into a fire! There is a danger of explosion!

• Do not throw used batteries into the household refuse; put them in a hazardous waste container or take them to a battery collection point, at the shop where they were purchased!

• The battery of this device must only be exchanged by specialized personnel. Never try to disassemble the battery on your own, but contact the service centre!

3.3 Setting the date and time

Before using the unit, you need to put the LOCK-switch to position "ON" (green). In "OFF" (red) - position the Bluetooth function is de- activated and all buttons are locked. i Press and hold the S-button for at least 3 seconds. i Firstly, the date figure starts to flash. Press M-button to adjust the actual month. i Press the S-button to confirm the setting. i Now the day figure starts flashing. Proceed accordingly for the input of day, year, hour and minute (as described under point 3 and 4). i On completion of the date and time setting, "Ok" appears on the dis- play. The unit switches off automatically after about 60 seconds, if no buttons are pressed in order to save power.

3.4 Setting up the user memory

The MEDISANA Wrist blood pressure monitor SL 100 connect gives you the opportunity to assign readings to one of two user memories, each of which provides 500 memory slots. Press and hold the M-button for at least 3 seconds, until the symbol for User 1 appears in the display. By pressing M-button you can switch User 1 and User 2 or Guest . If you choose "Guest", the values of the reading will not be saved. i Press the S-button to confirm your selection.

4.1 Fitting the cuff

Attach the clean cuff to the left wrist which is free from clothing with the palm of the hand facing upwards (fig.1). There should be a gap of approx. 1 cm between the cuff and the palm of the hand (fig.2). Press the Velcro tape firmly around the wrist ensuring that it is not so tight that it could falsify the measured result (fig.3).Correct position for taking readings:Carry out the measurement whilst seated.Relax your arm and place it comfortably, on a table for instance. Raise the wrist so that the cuff of the monitor is at heart level (fig. 4, position a = too high, b = correct, c = too low).

Relax during the measuring process: do not move or talk, as this can affect the results.With repeated measurements, blood accumulates in the arm which can lead to false reading. Consecutive blood pressure measurements shouldbe repeated after 3 minutes pause or after the arm has been held up in order to allow the accumulated blood to flow away.

4.2 Taking a blood pressure measurement

After appropriate positioning of the cuff, the measurement can begin.Before using the unit, you need to put the LOCK-switch to position "ON" (green). In "OFF" (red) - position the Bluetooth function is deacti- vated and all buttons are locked. iiSwitch the unit on by pressing the START/STOP button . All display characters are shortly shown in the display. This test can be used to check that the display is indicating properly and in full. The unit is ready for measurement and the number 0 appears. i The device automatically inflates the cuff slowly in order to measure your blood pressure. The rising pressure in the cuff is shown on the display.When the device detects the signal, the heart symbol on the display starts to flash. i If a result is determined, the device slowly will release the air from the cuff. The systolic and diastolic blood pressure and the pulse value with the time value appear on the display.

4 Operating 24The blood pressure indicator flashes next to the relevant coloured bar depending on the WHO blood pressure classification. If the unit has detected an irregular heartbeat, the arrhythmia display appears additionally. i The readings are automatically saved in the selected memory ( or ), except if a guest mode measuement has been finished (see chapter 3.4 Setting up the user memory). Up to 500 measured values with date and time can be stored in each memory. i The measurement results will automatically be transferred via Bluetooth to receiveready devices. During this process, the Bluetooth-symbol i will flash. If the transfer was successful, the Bluetooth-symbol will appear together with "OK" in the display. If the transfer was not success- ful, "Err" will appear. i The unit switches off automatically after approx. 1 minute if no buttons are pressed. The unit may also be switched off using the START/STOP button .

VitaDock app The MEDISANA Wrist blood pressure monitor SL 100 connect offers the possibility to transfer your measured values via Bluetooth to the Vita- Dock online portal resp. to the VitaDock app. These VitaDock appli- cations allow the evaluation, storage and synchronisation of your data between multiple iOS- and Android-devices to have access to it anytime and anywhere. You may share your results with your friends or your doc- tor. Therefore you need a free user account, which you can create on the website www.vitadock.com. For Android or iOS mobile devices, you may download the respective apps. You will find a detailed instruction for how to install and use the software on the mentioned website. After each blood pressure measurement an automatic transfer will be initiated by the device - Bluetooth therefore should be activated and configured on the receiving device(s). If you want to transfer the stored values from your SL 100 connect manually, please follow these steps: Press and hold START/STOP-button for 3 seconds, to enter the manual transfer mode. i The Bluetooth-symbol flashes and the transfer begins. i If the transfer was successful, the Bluetooth-symbol will appear together with "OK" in the display. If the transfer was not successful, "Err" will appear.

5.1 Displaying stored results

You can store up to 500 readings (blood pressure and pulse rate with the time and date) in either one of the two memories in your blood pressure monitor. The measured values are stored automatically. Press the M-but- ton to call up the measured values stored. The average values of the last 3 measurements of the respective user appear on the display. Press 5 Memory

255.2 Deleting memory

Press M-button to enter the memory recall mode. i If you only want to delete the last measured value, press and hold the S- button for approx. 7 seconds. The last measured value will flash two times and will then be deleted. The display shows "dEL". Press START/ STOP , to exit the delete mode. If you want to delete all stored values in memory for a user, press and hold M-button AND S-button simultaneously for approx. 10 seconds. The display shows "dEL ALL". Now press the to confirm the deletion. The display shows S-button "dEL OK" - now all stored values for this user are deleted and the unit will switch off automatically. If you want to abort the deletion process, press START / STOP while the display shows "dEL ALL". The unit then switches itself off without deleting any value.

5 Memory / 6 Miscellaneous

the M-button again to display the values from the previously stored measurement. Repeatedly pressing the M-button displays the respec- tive values measured previously. Press the to browse to the S-button more actual stored results. The unit switches off automatically after approx. one minute if no buttons are pressed. The memory recall mode may be exited at any time by pressing the START/STOP button . The oldest value is deleted if 500 measured values have been stored in the memory and a new value is saved.

6.1 Error messages and error remedying

Error indicators: 6 Miscellaneous Symbol Cause Correction + Lo Low battery Bluetooth transfer of data not possible Cuff not properly fitted Cuff too tight Failure during inflation Movement or speaking during measurement or pulse too weak The built-in battery is too low or empty. Charge the battery. Check the software and if Blue- tooth is properly configured and activated on the receiving units. Wrap the cuff properly. Remeasure in correct way. Wrap the cuff properly. Remeasure in correct way. Wrap the cuff properly. Remeasure in correct way. remeasure Rest 30 minutes and in correct way. Do not speak or move during the measurement. + Err

E10/E11Symbol Cause CorrectionPulse cannot bedetectedMeasurement failedCalibration errorMovement perceivedWrap the cuff properly. Remeasure in correct way.Rest 30 minutes and remeasure in correct way.Wrap the cuff properly. Remeasure in correct way.Do not speak or move during themeasurement. E20 E21 EExx

Please contact the service centre if you can’t solve the problem. Do not disassemble the unit by yourself.

6.2 Cleaning and maintenance

Never use strong detergents or hard brushes. iClean the unit with a soft cloth, moistened with mild soapy water. Do not let water enter the unit. After cleaning, only use the unit when it is completely dry. i Do not expose the unit to direct sunlight, and protect it from dust and moisture. i Only inflate the cuff when it is in position around the wrist. i Servicing and calibration i The unit has been calibrated by the manufacturer for a period of two years’ use. In the case of commercial use, the unit must be serviced and recalibrated at least once every two years. This calibration will be charged for and can be carried out by an appropriate authority or an authorised service centre - in accordance with the regulations for usersof medical equipment.

This product must not be disposed of together with domestic waste. All users are obliged to hand in all electrical or electronic devices, regardless of whether or not they contain toxic subs-tances, at a municipal or commercial collection point so that they can be disposed of in an environmentally acceptable manner.

Do not dispose of old batteries with your household waste, but at a battery collection station at a recycling site or in a shop. Consult your local authority or your supplier for information about disposal. i

6.4 Guidelines / Standards

This blood pressure monitor meets the requirements of the EU standard for noninvasive blood pressure monitors. It is certified in accordance with EC Guidelines and carries the CE symbol (conformity symbol) “CE 0297”. The blood pressure monitor corresponds to European standards EN 1060-1 and EN 1060-3. The specifications of EU Guideline “93/42/EEC of6.5 Technical specifications Name and model : Display system : Memory slots : Measuring method : Voltage supply : Measuring range blood pressure : Measuring range pulse : Maximum measuring deviation of static pressure : Maximum measuring deviation of pulse values : Pressure generation : Air release : Autom. switch-off : Operating conditions : Storage conditions : Dimensions : Cuff : Weight (approx.) : Item number : EAN number: Accessories : MEDISANA Wrist blood pressure monitor SL 100 connect Digital display 2 x 500 for measurement data Oscillometric 3.7V / 420 mAh via built-in battery, charging power 5V = / 1A with mini- USB-cable; with mains adaptor: 100-240V~, 50-60Hz, 0.18A 40 – 230 mmHg 40 – 199 beats per minute ± 3 mmHg ± 5 % of the value Automatic with pump Automatic After approx. 1 min. +5 °C to +40 °C, rel. humidity ≤ 85 % -20 °C to +60 °C, 10 to 93 % max. relative humidity approx. 80 x 65 x 13,2 mm Circumference 13,5 - 21,5 cm for adults approx. 100 g

In accordance with our policy of continual product improvement, we reserve the right to make technical and optical changes without notice.

the Council Directive dated 14 June 1993 concerning medical devices” are met and likewise those of the R&TTE directive 1999/5/EC. You can re- quest the complete Conformity Declaration from Medisana AG, Jagen- bergstrasse 1, 41468 Neuss, Germany, or you can also download it from the Medisana homepage (www.medisana.de). i Electromagnetic compatibility: (see attached leaflet)MEDISANA AG Jagenbergstraße 19 41468 NEUSS Germany eMail: info@medisana.de Internet: www.medisana.com The service centre address is shown on the attached leaflet. Please contact your dealer or the service centre in case of a claim under the warranty. If you have to return the unit, please enclose a copy of your receipt and state what the defect is. The following warranty terms apply:

1. The warranty period for MEDISANA products is three years from date

of purchase. In case of a warranty claim, the date of purchase has to be proven by means of the sales receipt or invoice.

2. Defects in material or workmanship will be removed free of charge

within the warranty period.

3. Repairs under warranty do not extend the warranty period either for

the unit or for the replacement parts.

4. The following is excluded under the warranty:

a. All damage which has arisen due to improper treatment, e.g. non- observance of the user instructions. b. All damage which is due to repairs or tampering by the customer or unauthorised third parties. c. Damage which has arisen during transport from the manufacturer to the consumer or during transport to the service centre. d. Accessories which are subject to normal wear and tear.

5. Liability for direct or indirect consequential losses caused by the unit

are excluded even if the damage to the unit is accepted as a warranty claim. Warranty and repair terms