Archos Blood Pressure Monitor ce0123 User Manual

* Thank you very much for selecting ARCHOS Blood Pressure Monitor. * Please do read the user manual carefully and thoroughly so as to ensure the safe usage of this product, and keep the manual well for your further reference in case you have problems.

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Version:1.0

User Manual

ARCHOS Blood Pressure Monitor

CATALOGUE

INTRODUCTION ......................................................................................................................................................................... 2

Safety Information LCD Display Signal Monitor Components

BEFORE YOU START ..................................................................................................................................................................6

Installing and Replacing the Batteries Setting Date and Time

MEASUREMENT........................................................................................................................................................................ 11

Tie the Cuff Start Measurement

DATA MANAGEMENT............................................................................................................................................................ 13

Recalling the Records Deleting the Records

INFORMATION FOR USER..................................................................................................................................................... 15

Tips for Measurement Maintenance

ABOUT BLOOD PRESSURE.................................................................................................................................................... 17

What are systolic pressure and diastolic pressure? What is the standard blood pressure classification? Why does my blood pressure fluctuate throughout the day? Why the blood pressure I get from the hospital is different from home? If the result is the same if measuring on the right wrist?

TROUBLESHOOTING.............................................................................................................................................................. 19

SPECIFICATIONS ..................................................................................................................................................................... 20

CONTACT INFORMATION..................................................................................................................................................... 21

COMPLIED EUROPEAN STANDARD LIST .........................................................................................................................21

EMC GUIDANCE .......................................................................................................................................................................22

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Table of Contents

INTRODUCTION

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: * Systolic Blood Pressure * Diastolic Blood Pressure * Pulse Rate * 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.

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Symbol for “THE OPERATION GUIDE MUST BE READ”

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

Symbol for “TYPE BF APPLIED PARTS”

Symbol for “SERIAL NUMBER” Symbol for “ENVIRONMENT

Symbol for “DIRECT CURRENT”

Symbol for “MANUFACTURE DATE”

Symbol for “MANUFACTURER”

Symbol for “Authorized Representative in the European Community”

The Bluetooth Combination Mark

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”

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 deate. Should the cu not deate when its pressure exceeds 40 kPa (300 mmHg), detach the cu from the wrist and press the START/STOP button to stop ination. 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 specied / authorized by

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CAUTION

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 inated long time, the patient’s wrist and ngers will is insucient, 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 eects of this device on the fetus are unknown.

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LCD Display Signal

SYMBOL DESCRIPTION EXPLANATION

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Systolic Blood Pressure High blood pressure

Diastolic Blood Pressure Low blood pressure

Pulse beat/minute

Low Battery Low battery and please replace the batteries.

Unit Measurement unit of blood pressure

Time Hour: Minute (Month/Day/Year)

IHB Detector Irregular Heartbeat Detector

Bluetooth Successful Bluetooth Connection

Error Error

Memory Recalling the history records

Monitor Components Component List:

1. PCBA; 2. Air Pipe; 3. Pump; 4. Valve; 5. Cu.

List

1. Wrist Blood Pressure Monitor 2. Two AAA-size batteries 3. User Manual BEFORE YOU START Installing and Replacing the Batteries

•.Open the battery door.

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

•.Close the battery door.

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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.

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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 conrm [HOUR]. Then the numeral representing [MINUTE] blinks.

4. Repeat step 2 and 3 to conrm [MINUTE].

5. Repeat step 2 and 3 to conrm [MONTH], [DAY] and [YEAR].

6. After conrming [YEAR], the LCD will display “DONE” and the monitor will shut o.

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Tie the Cu

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. M ake 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.

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If FAIL, symbol will be shown on the LCD.

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

MEASUREMENT Start Measurement

1. After correctly positioning the cu, press START button to turn on the monitor, and it will complete the measurement process automatically.

Adjust to zero.

Inating and measuring.

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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.

If the data transmission fails, the LCD will display “ERROR” instead.

4. Press STOP button to turn o the monitor. O therwise it will power o automatically.

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DATA MANAGEMENT Recalling the Records

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.

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

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

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.

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

Cleaning: Dust environment may aect 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 specied 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?

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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 classication? The blood pressure classication published by World

Health Organization (WHO) and International Society of Hypertension (ISH) in 1999 is as follows:

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Level BP (mm

Hg)

SYS <120 121-130 131-140 141-160 161-180 ≥180

DIA <80 81-85 86-90 91-100 101-110 ≥110

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 aected by the way you t i.e. your cu and your measurement position, so please take the measurement at the same condition.

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Optimal Normal Hypertension

G1 G2 G3

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 dierent from home? The blood pressure is dierent 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 dierent results for dierent 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.

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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

Low batteries

Error massage

not light up.

Display is dim or Display

shows

Batteries are exhausted. Replace with new batteries

Batteries are inserted incorrectly.

Batteries are low. Replace with new batteries

Data communication has failed

Insert the batteries correctly

Check if the APP is on or not, try data transmission again.

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Error 1 shows Ination is slow or the

Error 2 shows The cu is very tight Readjust the cu, not too loose or

Error 3 shows The pressure of the cu

cu is not secure.

is excess.

Refasten the cu and then measure again.

too tight and then measure again.

Refasten the cu and then measure again.

Error massage

SPECIFICATIONS

Power supply 2*AAA batteries

Display mode Digital LCD V.A.36x41mm

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Error 5 or Error 6 shows System error

Error 10 or Error 11 shows

Error 20 shows The measurement

Error 21shows on the display.

occurred.

The monitor detected motion, talking or the pulse is too poor while measuring.

process does not detect the pulse signal.

The treatment of the measurement failed.

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.

Relax for a moment and then measure again.

Loosen the clothing on the wrist and then measure again.

Relax for a moment and then measure again.

Measurement mode Oscillographic testing mode

Measurement range Pressure:0kpa-40kpa℃0mmHg-300mmHg℃

Accuracy Pressure:

Normal working condition Temperature:5℃-40℃

Relative humidity ≤80% Atmospheric pressure: 86kPa to 106kPa

Storage & transportation condition Temperature:-20℃ to 60℃

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

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pulse value:(40-199)beat/minute

5℃-40℃within±0.4kpa(3mmHg) 0℃-45℃(out of 5℃-40℃) within±0.7kpa(5mmHg) pulse value:±5%

Relative Humidity: 10% to 93% RH

Degree of protection Type BF applied part

Protection against ingress of water IP22

Software version V01

Device classication Internally Powered ME Equipment

WARNING: No modication 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: Schigraben 41, 30175 Hannover, Germany

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Complied European Standards List

Risk Management EN/ISO 14971:2007

Labeling EN 15223:2012

User Manual EN 1041:2008

General Requirements for Safety

Non-invasive Sphygmomanometers General Requirements

Electromagnetic Compatibility

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

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EN 60601-1:2006/AC2010

EN 60601-1-11:2010

EN 1060-1:1995+A2:2009 EN 1060-3:1997+A2:2009 EN 1060-4:2004

EN 60601-1-2:2007/AC:2010

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

RF emissions CISPR 11 Group 2 The device must emit

RF emissions CISPR 11 Class B

Harmonic emissions IEC 61000-3-2

Voltage fluctuations / flicker emissions IEC 61000-3-3

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Not applicable

– guidance

electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.

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

Electrostatic discharge (ESD) IEC 61000-4-2

Electrical fast transient / burst IEC 61000-4-4

Surge IEC 61000-4-5

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±6 kV contact ±8 kV air

±2 kV for power supply lines ±1 kV for input / output lines

±1 kV line(s) to line(s) ±2 kV line(s) to earth

environment – guidance

±6 kV contact ±8 kV air

Not applicable Mains power quality

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

should be that of a typical commercial or hospital environment.

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

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

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

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℃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

3 A/m 3 A/m Power frequency

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.

magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment

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

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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.

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

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.

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2.333

3 Vrms 150 kHz to 80 MHz

3 V/m 80 MHz to 2.5 GHz

Not applicable

3V/m

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:

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)

0.01 Not applicable 0.117 0.233

0.1 Not applicable 0.369 0.738

1 Not applicable 1.167 2.333

10 Not applicable 3.690 7.378

100 Not applicable 11.67 23.33

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Separation distance according to frequency of transmitter (m)

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

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