Blood Pressure Monitor - Smartwatch ARCHOS - Free user manual and instructions

USER MANUAL Blood Pressure Monitor ARCHOS

• Thank you very much for selecting ARCHOS Blood Pressure Monitor.

General Description Thank you for selecting ARCHOS Blood Pressure Monitor. The monitor features blood pressure measurement, pulse rate measurement and the result storage. The design provides you with two years of reliable service. Reading taken by the Blood Pressure Monitor are equivalent to those obtained by a trained observer using the cuff and stethoscope auscultation method. This manual contains important safety and care information, and provides step by step instructions for using the product. Read the manual thoroughly before using the product. FEATURES:

• Memory: Up to 60 pieces of records Safety Information The below signs might be in the user manual, labeling or other components. They are the requirement of standard and using. INTRODUCTION Manuel_BPM_book.indd 3 06/06/2014 10:21:204 Symbol for “THE OPERATION GUIDE

Symbol for “MANUFACTURER” Symbol for “COMPLIES WITH

MDD93/42/ECC REQUIREMENTS”

Symbol for “Authorized Representative in the European Community” Symbol for “TYPE BF APPLIED PARTS” The Bluetooth Combination Mark Symbol for “SERIAL NUMBER” Symbol for “ENVIRONMENT PROTECTION – Waste electrical 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 “DIRECT CURRENT” Symbol for “MANUFACTURE DATE” Manuel_BPM_book.indd 4 06/06/2014 10:21:205

CAUTION Please do read this user manual carefully and thoroughly before use. This device is intended for adult use only. This device is intended for non-invasive measuring and monitoring of arterial blood pressure. It is not intended for use on extremities other than the wrist 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. Please start or end medical treatment basing solely on physician’s treatment advice. If you are taking medication, consult your physician to determine the most appropriate time for your measurement. Never change a prescribed medication without your physician’s consent. This unit is not suitable for continuous monitoring during medical emergencies or operations. If the pressure of the cu exceeds 40 kPa (300 mmHg), the unit will automatically deate. Should the cu not deate when its pressure exceeds 40 kPa (300 mmHg), detach the cu from the wrist and press the START/STOP button to stop ination. Do not use the monitor under the conditions of strong electromagnetic eld (e.g. medical RF equipment) that radiates interference signal or electrical fast transient / burst signal. The maximum temperature that the applied part can be achieved is 42.5℃ while the environmental temperature is 40℃. The device is not AP/APG equipment. It is not suitable for use in the presence of a ammable anesthetic mixture with air (or oxygen, nitrous oxide). Please keep the unit out of reach of infants or children, since inhalation or swallowing of small parts is dangerous or even fata. Please use ACCESSORIES and detachable parts specied / authorized by Manuel_BPM_book.indd 5 06/06/2014 10:21:206 MANUFACTURER. Otherwise, it may cause damage to the unit or danger to the user / patient. Manufacturer will make available on request circuit diagrams, component parts listed. Sensitive people, including pregnant women and those who implanted medical electronic Instrument, should avoid using the unit whenever possible. This unit is not suitable for continuous monitoring during medical emergencies or operations. After the cu inated long time, the patient’s wrist and ngers will is insucient, anesthesia, distending pain and ecchymosis. Please use the device under the environment which was provided in the user manual. Otherwise, the performance and lifetime of the device will been impacted and reduced. During using, the patient will contact with the cu. The materials of the cu 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 allergic reaction or contact injury. The device has been evaluated clinically used manual cu/ stethoscope auscultation as the reference. The device doesn’t need to be calibrated in two years of reliable service. When the device was used to measure patients who have common arrhythmias such as atrial or ventricular premature beats or atrial brillation, the test result may occur deviation. Please consult your physician about the result. This device is contraindicated for any female subject who may be suspected of, or is pregnant. Besides provided inaccurate readings, the eects of this device on the fetus are unknown. Manuel_BPM_book.indd 6 06/06/2014 10:21:207

Installing and Replacing the Batteries

• .Open the battery door.

• .Insert the batteries according to the polarity indications. (Always select the authorized / specied battery: Two LR03 AAA-size batteries).

Battery Life: Approx. 57 days (Battery capacity: 600 mAH. If measured 3 times per day, each measurement takes 30s, and memory checked once per day, each checking takes 60s. The current for measurement is 350 mA, and that for records display is 50 mA while the current when shutdown is 25 uA.) Setting Date and Time Please proceed to time setting before your initial use so as to ensure each piece of record is labeled with a time stamp. (Year Range: 2012-2052; Time Format: 12 Hours)

1. When the monitor is OFF, press and hold “SET” button for 3 seconds to enter Time

Setting Mode. Manuel_BPM_book.indd 9 06/06/2014 10:21:2110

2. As pictured in the right, the blinking numeral “6” representing [HOUR]. Press “MEM”

button to change the numeral. Each press will increase the numeral by one in a cycling manner.

3. Press “SET” button again to conrm [HOUR]. Then the numeral representing

4. Repeat step 2 and 3 to conrm [MINUTE].

5. Repeat step 2 and 3 to conrm [MONTH], [DAY] and [YEAR].

6. After conrming [YEAR], the LCD will display “DONE” and the monitor will shut o.

1. Remove all accessories (watch, bracelet, etc.) from your wrist. If your physician has

diagnosed you with poor circulation in your wrist, use the other wrist.

2. Roll or push up your sleeve to expose the skin.

3. Apply the cu to your wrist with your palm facing up.

4. Position the edge of the cu about 1-1.5 cm.

5. Fasten the wrist cu around your wrist, leaving no extra room

between the cu and your skin. If the cu is too loose, the measurement will not be accurate. Resting for 5 minutes before measuring. Wait at least 3 minutes between measurements. This allows your blood circulation to recover. For a meaningful comparison, try to measure under similar conditions. For example, take daily measurements at approximately the same time, on the same wrist, or as directed by a physician. Pair-up the Blood Pressure Monitor with Your Device

1. Turn on Bluetooth and the app. Make sure both are ON

when pair-up is proceeding.

2. When the monitor is OFF, press and hold the START button

for 2 seconds to start pair-up. The symbol and the symbol will be shown on the LCD alternatively, indicating pair-up is proceeding. If SUCCEED, symbol will be shown on the LCD. Manuel_BPM_book.indd 11 06/06/2014 10:21:2112 If FAIL, symbol will be shown on the LCD.

3. The monitor will shut o automatically after Pair-up process is complete.

monitor, and it will complete the measurement process automatically. Adjust to zero. Inating and measuring. Manuel_BPM_book.indd 12 06/06/2014 10:21:2113

Display and save the measuring result.

2. This device will proceed to data transmission automatically after measurement.

The Bluetooth symbol blinks.

3. If the data is successfully transmitted, the LCD will display as pictured to the right.

1. Press “MEM” button to access the memory.

2. Press “MEM/UP” button or “SET/DOWN” button to rotate the history records. “MEM/

UP” to go forward; “SET/DOWN” to go backward. Deleting the Records When you did not obtain the accurate measurement, you can clear all the measuring results by following below steps.

1. Under Memory Recalling Mode, press and hold both the “MEM”

button and the “SET” button for 3 seconds. Manuel_BPM_book.indd 14 06/06/2014 10:21:2115

2. The LCD will display “dEL dONE”, indicating that memory clearing is

3. If you wish to give up clearing, press “START/STOP” to turn o the

4. When there is no memory in the monitor, if you press the “MEM”

button to look up History, the LCD will display as pictured to the right.

INFORMATION FOR USER

Tips for Measurement It can cause inaccuracy if the measurement is taken in the following circumstances. Manuel_BPM_book.indd 15 06/06/2014 10:21:2116 Maintenance To obtain the best performance, please follow below instructions. Cleaning: Dust environment may aect the performance of the unit. Please use the soft cloth to remove the dirt before use. Please make sure the unit functions safely and it is in proper working conditions before use. Please follow the instructions for correct replacement of interchangeable or detachable parts specied by SERVICE PERSONNEL of MANUFACTURER as “Replaceable”. Disposal: Degraded sensors or loosened electrodes may degrade the unit’s performance or even cause other problems. Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local guidelines.

ABOUT BLOOD PRESSURE

What are systolic pressure and diastolic pressure? Manuel_BPM_book.indd 16 06/06/2014 10:21:2217

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. What is the standard blood pressure classication? The blood pressure classication published by World Health Organization (WHO) and International Society of Hypertension (ISH) in 1999 is as follows: Manuel_BPM_book.indd 17 06/06/2014 10:21:2218 Level BP (mm Hg) Optimal Normal Hypertension G1 G2 G3

Irregular Heartbeat Detector This Wrist Blood Pressure Monitor is equipped with an intelligent function of Irregular Heartbeat (IHB) Detector. During each measurement, this equipment records the heartbeat intervals and works out the standard deviation. If the heartbeat intervals compare with the average intervals, the deviation more than 3 is over 25% or more than 5 is over 15%, this equipment will light up the IHB symbol on the screen when displaying the measuring result. Why does my blood pressure uctuate throughout the day?

1. Individual blood pressure varies every in one day, it also aected by the way you t

i.e. your cu and your measurement position, so please take the measurement at the same condition. Manuel_BPM_book.indd 18 06/06/2014 10:21:2219

2. The varies of the pressure is greater if the person take medicine.

3. Waiting at least 3 minutes for another measurement.

Why the blood pressure I get from the hospital is dierent from home? The blood pressure is dierent even during 24 hour because of the weather, emotion, exercise etc., especially the “white coat” in hospital which makes the results are higher than the ones at home. If the result is the same if measuring on the right wrist? It is ok for both wrists, but there will be some dierent results for dierent person, so suggest you measure the same wrist every time. The attention need to pay when you measure you blood pressure at home: If the cu is tied properly. If the cu is too tight or too loose. If the cu is tied on the wrist. If you feel anxious pressured. You had better take deep breath 2-3 times before beginning. Manuel_BPM_book.indd 19 06/06/2014 10:21:2220 Advice: adjust yourself for 4-5 minutes until you calm down. TROUBLESHOOTING This section includes a list of error messages and frequently asked questions for problems you may encounter with your wrist blood pressure monitor. If the products not operating as you think it should, check here before arranging for servicing.

PROBLEM SYMPTOM CHECK THIS REMEDY

No power Display will not light up. Batteries are exhausted. Replace with new batteries Batteries are inserted incorrectly. Insert the batteries correctly Low batteries Display is dim or Display Batteries are low. Replace with new batteries Error massage shows Data communication has failed Check if the APP is on or not, try data transmission again. Error 1 shows Ination is slow or the cu is not secure. Refasten the cu and then measure again. Error 2 shows The cu is very tight Readjust the cu, not too loose or too tight and then measure again. Error 3 shows The pressure of the cu is excess. Refasten the cu and then measure again. Manuel_BPM_book.indd 20 06/06/2014 10:21:2221

Error massage Error 5 or Error 6 shows System error occurred. Retake the measurement. If the problem persists, contact the retailer or our customer service department for further assistance. Refer to the warranty for contact information and return instructions. Error 10 or Error 11 shows The monitor detected motion, talking or the pulse is too poor while measuring. Relax for a moment and then measure again. Error massage Error 20 shows The measurement process does not detect the pulse signal. Loosen the clothing on the wrist and then measure again. Error 21shows on the display. The treatment of the measurement failed. Relax for a moment and then measure again. SPECIFICATIONS Power supply 2*AAA batteries Display mode Digital LCD V.A.36x41mm Manuel_BPM_book.indd 21 06/06/2014 10:21:2222 Measurement mode Oscillographic testing mode Measurement range Pressure:0kpa-40kpa℃0mmHg-300mmHg℃ pulse value:(40-199)beat/minute Accuracy Pressure: 5℃-40℃within±0.4kpa(3mmHg) 0℃-45℃(out of 5℃-40℃) within±0.7kpa(5mmHg) pulse value:±5% Normal working condition Temperature:5℃-40℃ Relative humidity ≤80% Atmospheric pressure: 86kPa to 106kPa Storage & transportation condition Temperature:-20℃ to 60℃ Relative Humidity: 10% to 93% RH Measurement perimeter of the wrist About 13.5cm-21.5cm Net Weight Approx.120g(Excluding the dry cells) External dimensions Approx.80×65×22mm Attachment 2*AAA batteries, user manual Mode of operation Continuous operation Manuel_BPM_book.indd 22 06/06/2014 10:21:2223

Degree of protection Type BF applied part Protection against ingress of water IP22 Software version V01 Device classication Internally Powered ME Equipment

WARNING: No modication of this equipment is allowed.

CONTACT INFORMATION Contact Information For more information about our products, please visit www.archos.com you can get customer service, usual problems and customer download, ARCHOS will serve you anytime. Manufactured by: GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD Company: GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD Address: Zone A, 5/F., Investment Building, No. 12, Huizhan East Rd., Torch Development District, Zhongshan, Guangdong, 528437, China Authorized European Representative: Company: MDSS - Medical Device Safety Service GmbH Address: Schigraben 41, 30175 Hannover, Germany Manuel_BPM_book.indd 23 06/06/2014 10:21:2224 Complied European Standards List Risk Management EN/ISO 14971:2007 Labeling EN 15223:2012 User Manual EN 1041:2008 General Requirements for Safety EN 60601-1:2006/AC2010 EN 60601-1-11:2010 Non-invasive Sphygmomanometers General Requirements EN 1060-1:1995+A2:2009 EN 1060-3:1997+A2:2009 EN 1060-4:2004 Electromagnetic Compatibility EN 60601-1-2:2007/AC:2010 Software Lifetime EN 62304:2006/AC:2008 Usability EN 60601-1-6:2010 EMC Guidance Table 1 – Guidance and MANUFACTURER’S declaration – ELECTROMAGNETIC EMISSIONS – for all ME EQUIPMENT and ME SYSTEM Manuel_BPM_book.indd 24 06/06/2014 10:21:2225

Guidance and manufacturer’s declaration – electromagnetic emissions The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment – guidance RF emissions CISPR 11 Group 2 The device must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. RF emissions CISPR 11 Class B Harmonic emissions IEC 61000-3-2 Not applicable Voltage fluctuations / flicker emissions IEC 61000-3-3 Not applicable Manuel_BPM_book.indd 25 06/06/2014 10:21:2226 Table 2 – Guidance and MANUFACTURER’S declaration – electromagnetic IMMUNITY – for all ME EQUIPMENT and ME SYSTEMS Guidance and manufacturer’s declaration – electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. IMMUNITY test IEC 60601 test level Compliance level Electromagnetic environment – guidance ±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%. Electrostatic discharge (ESD)

±2 kV for power supply lines ±1 kV for input / output lines Not applicable Mains power quality should be that of a typical commercial or hospital environment. Surge

±1 kV line(s) to line(s) ±2 kV line(s) to earth Not applicable Mains power quality should be that of a typical commercial or hospital environment. Manuel_BPM_book.indd 26 06/06/2014 10:21:2227

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 ℃5% UT (℃95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles ℃5% UT (℃95% dip in UT) for 5 s Not applicable Mains power quality should be that of a typical commercial or hospital environment. If the user of device requires continued operation during power mains interruptions, it is recommended that device be powered from an interruptible power supply or a battery. Power frequency (50/60 Hz) magnetic field

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE UT is the a.c. mains voltage prior to application of the test level. Manuel_BPM_book.indd 27 06/06/2014 10:21:2228 Table 3 – Guidance and MANUFACTURER’S declaration – electromagnetic IMMUNITY – for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacturer’s declaration – electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device 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 device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Manuel_BPM_book.indd 28 06/06/2014 10:21:2229

3 Vrms 150 kHz to 80 MHz Not applicable where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol: Radiated RF

3 V/m 80 MHz to 2.5 GHz 3V/m 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. 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 considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the device. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than[V1] V/m.

Manuel_BPM_book.indd 29 06/06/2014 10:21:2330 Table 4 – Recommended separation distances between portable and mobile RF communications equipment and the ME EQUIPMENT or ME SYSTEM – for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING Recommended separation distances between portable and mobile RF communications equipment at the device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device 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) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (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 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Manuel_BPM_book.indd 31 06/06/2014 10:21:2332 Version:1.0 Manuel de l’utilisateur Tensiomètre ARCHOS