BPM32B - Moniteur de pression artérielle AViTA - Free user manual and instructions

USER MANUAL BPM32B AViTA

AVITA Corporation SF, No. 78, Sec. 1, Kwang Fu Rd,

INSTRUCTION MANUAL Please read this instruction manual carefully before operating this unit

Contents Intended Use. Important Information Before Use . Blood Pressure Monitor Features … Description of LCD Display. Battery Installation . Setting the Date and Time Appiying Your Cuff… Measurement of Pulse Rate and Blood Pressure Hypertension Indicator.… Irregular Heartbeat Detector Memory Function ……. Data Transferring Error Codes...

Troubleshooting Cleaning and Disinfecting . Technical Specification: EMC Tables . Explanation of Symbols

The product automatically measures human beings Systolic, Diastolic blood pressure and pulse rate by oscillometric method. The measurement results are displayed on the LCD. Measurement position is at human being's wrist. The intended use of this over-the-counter device is for adults with wrist circumference ranging from 125 mm to 210 mm (Approx4.9 - 8.3 inches) and for home use. When the device detects the appearance of irregular heartbeats during measurement, an indicated symbol will appear with measuring readings.

This device is designed only for adults

Contra-indications Do not use in this case. (e.g. common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, arterial sclerosis, poor perfusion, diabetes, age, pregnancy, pre-eclampsia, renal diseases, patient motion, trembling, shivering, handicapped)

+ Beware of blood flow interference and resulting harmful injury to the patient caused by continuous cuff pressure.

Pressurization of the cuff can temporarily cause loss of function of monitoring ME equipment simultaneousl being used on the same im

Reading can be affected by the measurement site, the position of the patient, exercise, or patient's physiologic condition.

Automated sphygmomanometer can be affected by extremes of temperature, humidity and altitude.

Frequent measurements can cause injury to the patient due to blood flow interference.

+ Check that operation of the automated sphygmomanometer does not result in prolonged impairment of patient blood circulation. Retake tre measurement f unexpected readings are obtained Ensure that the cuff is not placed on an arm in which the arteries or

veins are undergoing medical treatment, e.g. intravascular access or therapy, or an arteriovenous (AV) shunt

This product is suitable for use in the home healthcare environment Keep this device out of the reach of children. Strangulation may result from baby or child entanglement in cables.

Please keep this device away from pets, pests, and children: Preventing potential allergic reaction, please avoid the device in direct contact to patient's wound.

Do not use with pregnant or pre-eclamptic patients

Do not use the cuff on people who have undergone a mastectomy. Do not apply the cuff over a wound, as this can cause further injury. Do not apply the cuff other than the original manufacturer provided Do not use this device other than the intended purposes.

Do not use in these cases (e.g. Device for use in an ambulance, helicopter or professional environment)

Cuff pressure 0 - 300 mmHg

Reduction rate: <30S Refer to IEC 80601-2-30

+ No modification of this equipment is allowed + High BMI health condition users may result varied

Important Information Before Use

1. Blood pressure measurements should only be interpreted by a physician or a trained health care professional who is familiar with your medical history. Through regular use of this device and recording of your measurements, you can keep your physician informed of the changes in your blood pressure.

2. Perform your measurement in a quiet place. You should be seated in a relaxed position

3. Avoid smoking, eating, taking medication, alcohol consumption or physical activity 30 minutes prior to taking a reading. If you are exhibiting signs of stress, avoid taking your measurement until the feeling subsides

4. Rest 15 minutes prior to taking a reading.

5. Remove any constrictive clothing or jewelry that may interfere with the cuff placement.

6. Keep the monitor stable during measurement to achieve an accurate reading. Remain still, do not talk during the measurement.

7. Record your daily blood pressure and pulse readings on a chart.

8. Take your readings at the same time, each day or as recommended by your physician to get an accurate indication of change in your true blood pressure

9. Wait a minimum of 15 minutes between readings to allow for the blood vessels to return to normal. The wait time may vary depending on your individual physiological characteristics.

10. Although such cases are rare, for those with an extremely weak pulse or irregular pulse, errors may result which prevent proper

measurement. If abnormal variations are noticed, consult with your physician or trained healthcare professional

11. This device is intended for adult use. While taking a measurement, you can stop the inflation or deflation process of the cuff at any time by pressing the POWER button

12. any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user is established.

For Customer Service, the blood pressure monitor is calibrated when manufactured, it is recommended that the accuracy should be maintained and calibrated by manufacture triennially (every 3 years). To obtain the service please contact AVITA Corp. for the address of the repair location. Enclose with the Proof of Purchase. Include $10.00 USD

for the return shipping and handling. Accompany with a letter with your name, address, phone number, and description of the specific problem or routine check-up. Pack the device carefully with bubble wraps (if there is) to prevent damages cause during transit. Due to possible losses in transit, it is recommended insuring the device with return receipt requested. fin any way of assistance of setting up, using, maintaining or to report unexpected operation/adverse events please contact manufacturer or local representative for further assistance.

FEDERAL COMMUNICATIONS COMMISSION INTERFERENCE STATEMENT This equipment has been tested and found to comply with the limits for à Class B digital device, pursuant to part 15 ofthe FCC Rules. These

limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

-Reorient or relocate the receiving antenna

Increase the separation between the equipment and receiver.

-Connect the equipment into an outlet on a circuit different from that to

which the receiveris connected -Consult the dealer or an experienced radio/ TV technician for help.

CAUTION: Any changes or modifications not expressly approved by the grantee of this device could void the user's authority to operate the equipment.

This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation:

The equipment complies with FCC RF exposure limits set forth for an uncontrolled environment.

The equipment must not be co-located or operating in conjunction with any other antenna or transmitter.

Canada, Industry Canada (IC) Notices

This device contains licence-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development

Canada’ s licence-exempt RSS(s). Operation is subject to the following two conditions:

() This device may not cause interference

(2) This device must accept any interference, including interference that may cause undesired operation of the device.

Description of LCD Display

Average Measurement Symbol

OK Positioning Indicator “OK”

Battery Installation

Low battery warning; Itis necessary to replace the batteries when the Low Battery symbol appears on the display, or when the display does not turn on after the POWER button is pressed.

Replacing the Battery:

- Slide the battery cover on the bottom of the monitor.

-_ Insert or replace 2 x 1.5 V AAA batteries into the battery compartment, ensuring to match the indicated polarity symbols. Always use new batteries.

- Replace the battery cover.

Battery-operated = Always use NEW batteries; never mix old and new batteries + Please properly dispose ofthe batteries away from small children

Itis recommended to remove the batteries if the unit will not be

used for an extended period of time

- Batteries must be disposed of in accordance with local environmental and institutional policies.

- Remove the battery during extended storage.

= Itis recommended not to use rechargeable, unqualified or different spec battery may damage the device or cause circuit shorteut.

Setting the Date and Time

Itis necessary to set the date and time for the unit every time batteries are initially installed or replaced ( After replacing batteries, the “Year” will begin to flash on the display. @) Pressthe "+" button to advance or “-"_ button to retrogress the display to the desired “Year” press "M" buttonto

(3) Next,the “Month” will blink. Repeat steps 2 to setthe “Month” and “Day then ‘hour’ ,then “Minute”

(4) After setting the minute, the unit will automatically exit out or

press power button the date/time setting mode and briefy show the word OFF before shutting down.

Itis important to avoid smoking, eating, taking medication, alcohol consumption or physical activity 30 minutes prior to taking a reading. If for any reason you are unable to or should not use your left wrist, glesse modif ne instructions for cuff application £o your right rise Your physician can help you identify which wrist is best for you to take measurements from.

- Remove any constrictive clothing or jewelry that may interfere with cuff placement

: Be eated at table or deskth your feet la on the

Hold your wrist in front of you at heart level with

your palm facing upward

- Apply the preformed cuffto your wrist so thatthe digital display face is positioned on the inside area

of your wrist facing you

= Adjust the cuff approx. 1 cm from the edge of the head of the ulna bone.

-_ The cuff should fit comfortably, yet snugly around your wrist.

- Blood pressure naturally varies from one wrist to the other: therefore, measure your blood pressure on the same wrist to ensure comparability of the two readings

Measurement of Pulse Rate and Blood Pressure

Please read the preceding portions of this manual prior to taking your first reading, (1) Rest your elbow on a solid surface with your palm facing upward. Elevate your wrist So that the cuff is at the same level as your heart. Relax your left hand (2) Press the POWER button. This will turn the power on. . (3) While your position is improper, the Pnsitioning symbol and the Positioning indicator ‘Æ" or “ Ÿ ” flash to guide you up or down your wrists, when you are in proper position the Positioning symbol "OK". flash. After the Positioning symbol flash for 3 times, the wrist cuff will start to inflate automatically. (&) The Wrist Positioning Guide can be used as an aid to help an end user determine if the device is at an appropriate position.

The measurement starts automatically once the correct position has been obtained. Do not move or speak while the measurement is in progress.

The cuff will automatically begin to inflate, with the display showing the increasing pressure in the cuff As the pressure increases, an arrow pointing up will appear on the display.

To detect the heartbeat, the heartbeat symbol will appear and continuous flashes on the LCD display.

Your blood pressure measurement and pulse will display simultaneously on the screen

The Hypertension Indicator will indicate your reading range on the display separately.

The reading will automatically be stored in memory{You can press” +" or” - "button in standby mode to select Userl or User2 as the default storage zone)

Select POWER to turn the unit off and conserve energy and battery life. The unit will automatically shut-off approximately 2

minutes. Hypertension Indicator

This monitor comes equipped with a Hypertension Indicator that automatically compares each reading to defined levels established by the World Health Organization and provides a helpful cue if your reading fall into one of the stages that could potentially indicate increased risk. Please note that cues provided by this monitor are only intended to assist you in using this table. The table and cues are only provided for convenience to help you understand to the level information. They are not a substitute for a medical examination by your physician. His important for you to consult with your physician regulary. Your range as well as the point at which you may actually be considered to be at risk.

Irregular Heartbeat Detector

Your digital blood pressure monitor features an Irregular Heartbeat Detector. regular Heartbeats may influence the results of the measurement. lfthe monitor detects the Irregular Heartbeats during measurement, the symbol will appear on the display with the measurement values. You can take another measurement to make sure the values are not influenced by moving during measurement or Irregular Heartbeat.

The appearance of the 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.

INPORTANT INFORMATION:

This blood pressure monitor is not designed for use by people with arrhythmias nor for diagnosing or treating an arrhythmia problem. As a safeguard, we recommend that if you have arrhythmias such as atrial or ventricular premature beats and atrial fibrillation or any other special conditions you should check with your physician before using your blood pressure monitor.

Recalling Measurements in Memor @

Press and release the M button. The unit ill first display the average of the last 3 stored measurements.

Continue to press the “M” button to successively view the next previously stored measurements. Measurements will appear on the display from most current to oldest; the memory number will appear on the lower right comner.

Al results for a given measurement will display, including measurement results, pulse rate, Hypertension Indicator, and date/time stamp.

When the number of readings exceeds 100, the oldest data will be replaced with the new record.

Press the Power button to turn the monitor OFF at any time during review of the stored measurements.

User memory: To select the relevant user memory, press the button ‘+"_or

“when the device is switched off.

A3 showed on the display. The average value of the last 3 stored measurements in this user memory is displayed!

AM showed on the display.

The average value of the morning measurements for the last 7 days

is displayed (morning: 5 a.m.-9 am)

PM showed on the display.

The average value of the evening measurements for the last 7 days

is displayed (evening: 6 p.m.-8 pm).

Clearing Measurements from Memory: From power display off press and ho doun the “M°_ button until the

display shows CLr This indicates that all measurements have been erased.

This product is a wrist type blood pressure monitor. Design without entering personal information, The device has a transmission function During the transmission process, the measurement data is designed to be encrypted, and will not be tampered with unauthorized access nor retrieve user-related information. The firmware and software of the product have been pre-programmed in the production stage. Both the burned in microcontroller programmer and the software were designed encrypted; there is no concern about the software safety.

Bluetooth function requirement: An Android device with Android version 4.3 or above and hardware support for Bluetooth 4.2 An iOS device with iOS version 5 or above and hardware support for Bluetooth 4.2.

Please refer to the instruction manual of your smart phone for how to activate the Bluetooth function.

). Please determine your mobile phone or computer has BLEA.2 (2) Turn on the BPM328, it means BPM328 is under broadcast condition.

(3) Please check the connecting condition from your mobile phone or computer. The device name should be “BPM32B"

(4). Every measure reading will be transfer to your mobile phone or computer automatically.

You can send results in memory zone as following step (1. Press Memory recall button of blood pressure monitor to enter memory mode. The symbol AVG and M will appear on the display and the number of memory index is _ "A3"

(2) 2. Turn on the Bluetooth function of device to search the blood pressure monitor. Then the blood pressure monitor will be searched and connected the Bluetooth device.

(3) 3. After the connection is completed, you can press memory recall button to display the memory result on LCD. Each result showed on LCD, the result will be transmitted by Bluetooth immediately.

Error Code Cause Corrective Action Err 00 _ [No pulse or detect Fake offheavy clothes and retry again. bpuises not enough ErO1 [Leakage in Cuff Fhe wrist cuffis not fastened properly. Pressure/Inflation too low. overpressure protection

Error Code Cause Corrective Action Err02 [Measuredabnormal [Take arest for 3-5 minutes. Re-apply values he cuff and take a measurement again. Err03 [inflation fault Re-apply the cuff and take a measurement again. Er [Memory error. Fake off batteries to reboot the device, fhen take another measurement. a |rowbatteries Replace all batteries with new ones.

Problem Cause Remed Me reading _ÎMhewrist cuffis not at Measure while inthe correct Îs extremely heart level osture. low (or ÎThe cuff is not wrappedWrap the cuff correctiy high) nugly around the rrist. ÎThe arms and Relax and try taking the houlders are tense. [measurement again Movement or talking Remain still and do not talk fduring measurement. Muring measurement.

ÎMhe blood pressure is different each ime. The reading is extremely low (or

Blood pressure readings onstantly vary with time of

high) lay and how relaxed you are. [Take several deep breaths and ry to remain relaxed before king à measurement.

[Nothing ÎThe batteries have Insert the batteries with the

Ihappens when been inserted orrect (+/-) polarity. Refer

jou pressthe incorrectly 0 5.1.

(Overpressure ÎMhe machine mustbe

(protection ladjusted according to the

instruction manual and with rofessional. equipment

IErrors with rist positional

ÎThe machine must be

ladjusted according to the

instruction manual and with rofessional

Cleaning and Disinfecting

+ Only use a soft, damp cloth to clean the monitor. Please do not use thinner, alcohol, detergents or solvents.

+ The cuff can be cleañed carefully using a slightly damp cloth and mild soap solution. Do not completely immerse the cuff in water.

+ Itis recommended to clean and disinfect the cuff regularly or after each use, especially when used by several users, to prevent infection The cuff should be disinfected, particularly on the inside, by wiping with a disinfectant. Use a disinfectant that is compatible with the cuff materials, e.g. 75 % ethanol or isopropyl alcohol

+ Keep the monitor in the appropriate carriage to protect it from external influences.

Technical Specification

Pulse rate : + 4% of reading

Operating environment :

10°C-40'C (50°F-104%F)

15% to 85% relative humidity (non-condensing) Atmospheric Pressure: 700-1060 hPa

Storage/ Transportation environment -20°C-+50"C (-4°F-+122°F) 1"

15% to 85% relative air humidity (non-condensing) Atmospheric Pressure: 700-1060 hPa

Power Source : 2 x 1.5 V LRO3 (AAA) alkaline

+ Weight : approx. 110g (exclude batteries)

BPM328 fs intended for use in the electromagnetic environment specified below. The customer or the user of BPM32B must make sure hat it is used in such an environment.

Guidance and manufacturer”_s declaration - Electromagnetic emissions CISPR 11

CISPR IL Group 1 Class À (Not BLE |Group 1 Class B (Not Phenomenon |Function) BLE Function) Group 2 Class A (With |Group 2 Class B (With BLE Function) BLE Function) Conducted and Not applicable

radiated RF MISSIONS |(Note: Power by Battery or DC Input) Only the AC input needs to be tested

Harmonie distortion [Not applicable Note: Power by Battery or DC Input) Only the AC input needs to be tested

Vos Auctuations _CISPR II and flickerinq Group 1 Class A (Not BLE Function)

[Group 2 Class À (With BLE Function)

a) The equipment fs suitable for use in Home Health Environments and Professional Health Care Environments limited to patient rooms and respiratory treatment facilities in hospital or clinics. The more restrictive acceptance limits of Group 1 Class B LCSPR 11) have been considered and applied. The equipment is suitable for use in the mentioned lenvironments when directly connected to the Public Mains Network

b) The test is not applicable in this environment unless the ME EQUIPMENT and ME SYSTEM used will be connected to the PUBLIC MAINS NETWORK and the power input is otherwise within the scope of the Basic EMC standard

Guidance and manufacturer” s declaration - Electromagnetic mmuntty L'Enclosure port

Phenomenon [Basic EMC _lImmuniytestievels

standard or Professional [HOME HEALTHCARE test method |healthcare [ENVIRONMENT facility

Radiated RF EM fields

a) 10 V/m b) 80MHz - 2.7 GHz 80% AM at 1kHz

Proximity felds from RF Wireless communications equipment

COMPLIANT NOTE: Further information about distances to be maintained between portable and mobile RF communications equipment. fiansmiters) and the BPM328 can be requested from supplier using the contact information provided in this manual. However it is advisable to keep the electromechaniçal aerosol equipment at an adequate distance of at least, 0.5 m from mobile phones or other RF communications transmitters to minimise possible interference.

Frequency. 50 Hz or 60 Hz magnetic fields,

2) The equipment 5 suitable for use in Home Health Environments and

Professional Health Care Environments limited to patient rooms and

res] Ron treatment facilities in hospital or clinics. The more restrictive

UNITŸ acceptance limits have been considered and applied

b) Before modulation is applied

6) Thie test level gssumes 8 Minimum distance of at least 15 cm betueen E EQUIPMENT or ME SYSTEM and sources of power frequency

Explanation of Symbols

Symbol Definition The CE marking with the Registration Number of the Notified Body. This denotes the compliance of Regulation (EU) 2797 2017/745

Authorized representative in the European Community

Consult the instruction for use

Disposal information: Should you wish to dispose of the article, do so in accordance with current regulations. Details are available from your local authority. WEËE 2012/19/EU Directives

This product fuifiling the requirements of the RoHS Directive 2011/68/EU

This product fulfiling the requirements of the REACH Directive EC 1907/2006 and its amendments, do not contain ReAcH | Substances of Very High Concern in concentration above

the limit of 0.1 %. No substance(s) is/are present in the parts ofthe product above the concentration of 0.1 % weight by weight.

Device classification type BF

This product meets the basic safety and essential performance requirements indicated in the IP22 conditioning IP 22 | test (protection against solid foreign objects of 12.5mm @

and greater and against vertically falling water drops when enclosure tiled up to 15°)

The emply, completely flat batteries must be disposed of

X through specially designated collection boxes, recycling points or electronics retailers. You are legally required to dispose of the batteries.

Country of Manufacturer

Keep away from sunlight