TENSiOSMART - Tensiomètre TERRAILLON - Free user manual and instructions

USER MANUAL TENSiOSMART TERRAILLON

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General Description * Thank you for selecting TERRAILLON Blood pressure Monitor (LS808-B). The monitor features blood pressure measurement, pulse rate measurement and the result storage. The design provides you with two years of lifetime. * This manual contains important safety information and caution, and provides step by step instructions for using the product. * Please do read this user manual carefully and thoroughly before use. FEATURES: 86.1mm×24mm Blue LCD Display with White Backlight Measure-during-inflating Technology Up to 60 pieces of record stored

Indications for Use The TERRAILLON Blood Pressure Monitor is digital monitors intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22 cm to 32 cm ( about 8¾˝-12½˝ ). It is intended for adult indoor use only.

Measurement Principle This product uses the Oscillometric Measuring Method to detect blood pressure. Before every measurement, the unit establishes a “zero point” equivalent to the atmospheric pressure. Then it starts inflating the cuff. Meanwhile, the unit detects pressure oscillation generated by beat-to-beat pulsatile, which is used to deter-mine the systolic pressure and diastolic pressure as well as pulse rate. The device also compares the longest and the shortest intervals of detected pulse wave to with the average value, and then calculates the standard deviation.

Safety Information The below signs might be in the user manual, labeling or other components. They are the requirement of standard and using. Symbol for “THE OPERATION GUIDE MUST BE READ”

Symbol for “TYPE BF APPLIED PARTS”

Symbol for “COMPLIES WITH MDD93/42/EEC REQUIREMENTS”

Symbol for “ENVIRONMENT PROTECTION - Electrical waste products should not be disposed of with household waste. Please recycle where facilities exist. Check with your local authority or retailer for recycling advice”

Symbol for “MANUFACTURER”

Symbol for “DIRECT CURRENT” Symbol for “SERIAL NUMBER”

EC REP Symbol for “Authorised Representative in the European Community”

The Bluetooth Combination Mark

T1A/250V 3.6*10CCC Symbol for “MANUFACTURE DATE For indoor use only

Symbol for “Class II Equipment”

Caution: These notes must be observed to prevent any damage to the device.

Symbol for “Including RF transmitter”

CAUTION This device is intended for adult use only. This device is intended for no-invasive measuring and monitoring of arterial blood pressure. It is not intended for use on extremities other than the arm or for functions other than obtaining a blood pressure measurement. Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood pressure. Do not begin or end medical treatment without asking a physician for treatment advice. If you are taking medication,consult your physician to determine the most appropriate time to measure your blood pressure. Never change a prescribed medication without consulting your Physician. When the device was used to measure patients who have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, the best result may occur with deviation. Please consult your physician about the result. If the cuff pressure exceeds 40 kPa (300 mmHg), the unit will automatically deflate. Should the cuff not deflate when pressures exceeds 40 kPa (300 mmHg), detach the cuff from the arm and press the corresponding user button to stop inflation. The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable anesthetic mixture with air of with oxygen or nitrous oxide. The operator shall not touch output of adapter and the patient simultaneously. To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated interference signal or electrical fast transient/burst signal. The user must check that the equipment functions safely and see that it is in proper working condition before being used. This device is contraindicated for any female who may be suspected of, or is pregnant. Besides providing inaccurate readings, the effects of this device on the fetus are unknown. Manufacturer will make available on request circuit diagrams, component parts list etc. This unit is not suitable for continuous monitoring during medical emergencies or operations. Otherwise, the patient’s arm and fingers will become anaesthetic, swollen and even purple due to a lack of blood. Please use the device under the environment which was provided in the user manual. Otherwise, the performance and lifetime of the device will be impacted and reduced. During use, the patient will be in contact with the cuff. The materials of the cuff have been tested and found to comply with requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not cause any potential sensization or irritation reaction. Please use ACCESSORIES and detachable partes specified/ authorised by MANUFACTURE. Otherwise, it may cause damage to the unit or danger to the user/patients. The device doesn’t need to be calibrated within the two years of reliable service. Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local guidelines. If you have any problems with this device, such as setting up, maintaining or using, please contact the SERVICE PERSONNEL of TERRAILLON. Don’t open or repair the device by yourself. Please report to TERRAILLON if any unexpected operation or events occur. Please use the soft cloth to clean the whole unit. Don’t use any abrasive or volatile cleaners.

Tips for Measurement Measurements may be inaccurate if taken in the following circumstances.

Within 1 hour after dinner or drinking

Immediate measurement after tea, coffe, smoking

Within 20 minutes after taking a bath

When talking or moving your fingers

In a very cold environment

When you want to discharge urine

Maintenance To obtain the best performance, please follow below instructions.

Put in a dry place and avoid the sunshine

Avoid immersing it in the water. Celan it with a dry cloth in case

Avoid intense shaking and collisions

Avoid dusty environment and unstable temperature surrounding

Use the slightly damp cloth to remove the dirt

Avoid washing the cuff

What are systolic pressure and diastolic pressure? When ventricles contract and pump blood out of the heart, the blood pressure reaches its maximum value in the cycle, which is called systolic pressure. When the ventricles relax, the blood pressure reaches its minimum value in the cycle, which is called diastolic pressure.

The blood pressure classification published by World Health Organization (WHO) and International Society of Hypertension (ISH) in 1999 is as follows:

CAUTION Only a physician can tell your normal BP range. Please contact a physician if your measuring result falls out of the range. Please note that only a physician can tell whether your blood pressure value has reached a dangerous point.

Level Blood Pressure (mm Hg)

Diastolic blood pressure (mmHg)

What is the standard blood pressure classification?

Grade 3 hypertension (severe) Grade 2 hypertension (moderate) Grade 1 hypertension (mild) Subgroup: borderline High-normal Blood Pressure Normal Blood Pressure Optimal Blood Pressure

Irregular Heartbeat Detector An irregular heartbeat is detected when a heartbeat rhythm varies while the unit is measuring the systolic and diastolic blood pressure.During each measurement, this equipment records the heartbeat intervals and works out the standard deviation. If the calculated value is larger than or equal to 15,the irregular heartbeat symbol appears on the symbol when the measurement results are displayed.

CAUTION The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heartbeat was detected during measurement. Usually this is NOT a cause for concern. However, if the symbol appears often, we recommend you seek medical advice. Please note that the device does not replace a cardiac examination, but serves to detect pulse irregularities at an early stage.

Why does my blood pressure fluctuate throughout the day? 1. Individual blood pressure varies multiple times everyday. It is also affected by the way you tie your cuff and your measurement position, so please take the measurement under the same conditions. 2. If the person takes medicine, the pressure will vary more. 3. Wait at least 3 minutes for another measurement.

Why do I get a different blood pressure at home compared to the hospital? The blood pressure is different even throughout the day due to weather, emotion, exercise etc, Also, there is the “white coat” effect, which means blood pressure usually increases in clinical settings.

Is the result the same if measuring on the right arm?

What you need to pay attention to when you measure your blood pressure at home: If the cuff is tied properly. If the cuff is too tight or too loose. If the cuff is tied on the upper arm. If you feel anxious. Taking 2-3 deep breaths before beginning will be better for measuring. Advice: Relax yourself for 4-5 minutes until you calm down.

It is ok for both arms, but there will be some different results for different people. We suggest you measure the same arm every time.

SPECIFICATIONS Power supply

3.7V 1000mAH Built-in rechargeable li-polymer 1A AC Adaptor

battery, 6V Display mode

Blue LCD with White Backlight V.A.= 86.1mm(L) x24mm(W)

Normal working condition

Temperature:5°C to 40°C Relative humidity: ≤85%RH Atmospheric pressure: 86kPa to 106kPa

Storage & transportation condition

Temperature:-20°C to 60°C Relative humidity: 10%RH to 93%RH Atmospheric pressure: 50kPa to 106kPa

Measurement perimeter of the upper arm

Continuous operation

Degree of protection

Type BF applied part

Protection against ingress of water

IP22, It means the device could protected against solid foreign objects of 12.5 mm and greater, and against vertically falling water drops when ENCLOSURE tilted up to 15°

Device classification

Battery Powered Mode: Internally Powered ME Equipment AC Adaptor charged Mode: Class II ME Equipment

WARNING: No modification of this equipment is allowed.

Complied European Standards List Risk management

ISO/EN 14971:2012 Medical devices — Application of risk management to medical devices

ISO/EN 15223-1:2012 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements

EN 1041: 2008 Medical equipment manufacturers to provide information

General Requirements for Safety

EN 60601-1: 2006+A1:2013 Medical electrical equipment - Part 1: G eneral requirements for basic safety and essential performance IEC/EN 60601-1-11: 2010 Medical electrical equipment -Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment IEC/EN 80601-2-30:2009 Medical electrical equipment Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers

Electromagnetic compatibility

IEC/EN 60601-1-2:2007 Medical electrical equipment Part 1-2: G eneral requirements for basic safety and essential performance - Collateral standard:Electromagnetic compatibility Requirements and tests

Performance requirements

EN 1060-1:1995+A2:2009 Non-invasive blood pressure Part 1: G eneral requirements EN 1060-3:1997+A2:2009 Non-invasive blood pressure Part 3: Supplementary requirements for electromechanical blood pressure measuring system

Clinical investigation

EN 1060-4: 2004 Automatic Blood Pressure Monitor overall system Interventional accuracy of the testing process

IEC/EN 60601-1-6: 2010 Medical electrical equipment -Part 1-6: G eneral requirements for basic safety and essential performance - Collateral Standard: Usability IEC/EN 62366: 2007 Medical devices - Application of usability engineering to medical devices

Software life-cycle processes

IEC/EN 62304:2006+AC: 2008 Medical device software - Software life cycle processes

EMC Guidance 1) This equipment needs to be installed and put into service in accordance with the information provided in the user manual; 2) Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies can affect this equipment and should be kept at least a distance d=3,3m away from the equipment. (Note: As indicated in Table 6 of IEC 60601-1-2:2007 for ME EQUIPMENT, a typical cell phone with a maximum output power of 2 W yields d=3, 3m at an IMMUNITY LEVEL of 3V/m)

Athorized Component 1. Please use the TERRAILLON authorized adaptor

Adaptor Input: 100-240V~50/60Hz 0.3A Max Output: 6V

1A CAUTION 1. The battery of LS808-B is built-in rechargeable li-polymer battery, please do not disassemble it by the unauthorized maintenance personel. 2. Under the normal using, it can charge power about 300 times, if the battery cannot charge the power normally or the blood pressure monitor cannot use normally, please connect with the authorized maintenance personel. If measured three times per day, and the battery is fully charged, it can be used for about 20 days. 3. Storge and use the blood pressure monitor at the cool, dry and ventilated environment. Avoid to approach to the fire and the heat source, or it will cause the battery explode. 4. Only can use the TERRAILLON’s authorized AC Adaptor(6V 1A) to charge the power. You cannot use the blood pressure monitor during the process of charging. 5. During the process of charging, the blood pressure monitor display When the charging is finished, please pull the plug in time. 6. When charging, shall not touch charging connector and the patient simultaneously.

Table 2 Guidance and manufacturer’s declaration – electromagnetic immunity – for all ME EQUIPMENT and ME SYSTEMS Guidance and manufacture’s declaration – electromagnetic immunity The LS802-B is intended for use in the electromagnetic environment specified below. The customer of the user of the LS802-B should assure that it is used in such an environment Immunity test

Electrostatic discharge (ESD) IEC 61000-4-2

±6 kV contact ±8 kV air

±6 kV contact ±8 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/burst IEC 61000-4-4

±2 kV for power supply lines

±2kV for power supply lines

Mains power quality should be that of a typical commercial or hospital environment.

±1 kV line(s) to line(s)

±1 kV differential mode

Mains power quality should be that of a typical commercial or hospital environment.

<5% UT (>95% dip in UT ) for 0.5 cycle

<5% UT (>95% dip in UT ) for 0.5 cycle

40% UT (60% dip in UT ) for 5 cycles

40% UT (60% dip in UT ) for 5 cycles

70% UT (30% dip in UT ) for 25 cycles

70% UT (30% dip in UT ) for 25 cycles

<5% UT (>95% dip in UT ) for 5 sec

<5% UT (>95% dip in UT ) for 5 sec

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Power frequency (50Hz) magnetic field IEC 61000-4-8 NOTE

Mains power quality should be that of a typical commercial or hospital environment. If the user of LS802-B requires continued operation during power mains interruptions, it is recommended that LS-802-B be powered from an interruptible power supply or a battery. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

UT is the a.c. mains voltage prior to application of the test level.

Table 4 Guidance and manufacturer’s declaration – electromagnetic immunity – for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacture’s declaration – electromagnetic immunity The LS802-B is intended for use in the electromagnetic environment specified below. The customer of the user of the LS802-B should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the LS802-B, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.167

Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3

3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacture and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, ashould be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection 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 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 the LS802-B is used exceeds the applicable RF compliance level above, the LS802-B should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the LS802-B. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

Table 6 Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM – for ME EQUIPMENT or ME SYSTEM that are not LIFE-SUPPORTING Recommended separation distances between portable and mobile RF communications equipment at the LS802-B. The LS802-B is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the LS802-B can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmittters) and the LS802-B 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)

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 NOTE 4

At 80MHz and 800MHz, the separation distance for the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO.,LTD Zone A, 5/F., Investment Building, No. 12, Huizhan East Rd., Torch Development District, Zhongshan, Guangdong, 528437, China

EC REP MDSS - Medical Device Safety Service GmbH Schiffgraben 41, 30175 Hannover, Germany

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