AVITA BPM835-LJB Arm Type Blood Pressure Monitor Instruction Manual

Arm Type Blood Pressure Monitor
Model:
BPM835-LJB
INSTRUCTION MANUAL

BPM835-LJB Arm Type Blood Pressure Monitor

PLEASE READ THIS INSTRUCTION MANUAL COMPLETELY BEFORE OPERATING THIS UNIT

| MDSS GmbH
Schiffgraben 41
30175 Hannover Germany
---|---
| AViTA Corporation
9F., No. 78, Sec. 1, Kwang Fu Rd.,
San Chung Dist., New Taipei City 24158, Taiwan, China
| China, AViTA(WUJIANG)
| Importer
| Distributor

Intended Use

The product automatically measures human being’s 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 upper arm. The intended use of this over-the-counter device is for adults with upper arm circumference ranging from 220 mm to 420 mm (Approx.8.7 ~ 16.5 inches) and for home use. When the device detects the appearance of irregular heartbeats such as atrial or ventricular premature beats during measurement, an indicated symbol will appear with measuring readings.

This device is designed only for adults.
Type of Use/ Reuse
Multiple patient multiple use
Intended User
The Arm type blood pressure monitor is intended or both professional and consumer, and the patient is the intended operator.
Patient selection criteria: Handicapped persons and children are the exception, as of handicapped persons and children need assistance by another person to use the device.
Contra-indications
Do not use in these cases: common arrhythmias such as atrial or ventricular premature beats, atrial fibrillation, arterial sclerosis, poor perfusion, diabetes, age, renal diseases, patient motion, trembling, shivering

CAUTION:

• Beware of blood flow interference and resulting harmful injury to the patient caused by continuous cuff pressure.
• While using monitoring ME equipment and blood pressure monitor simultaneously being used on the same limb, pressurization of the cuff may cause monitoring ME equipment temporarily dysfunction.
• 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.
• Improper operation of automated sphygmomanometer may result in prolonged impairment of patient blood circulation, please read manual for proper use, if still not clear, contact professional health care personnel or local  distributor for assistant.
• Retake the measurement if 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 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 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.
• Users shall notify serious adverse event to the central competent authority or its commissioned agency, legal entity, or manufacture.

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. If 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.
13. Do not expose the device to extreme temperatures, humidity dust or direct sunlight as this may cause it to malfunction.
14. Please comply with the storage and operating conditions defined in ‘Technical Specification’. Storing or using the device outside of the specified temperature and humidity range can affect measurement accuracy or the function of  the device.
15. If the device was not stored within the minimum/maximum permissible storage conditions, a waiting period of at least 2 hours must be observed before using it under the specified operating conditions (‘Technical Specification’) or  an ambient temperature of approx. 20 °C.

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. If in 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.

Product Identification

Description of LCD Display

| Low battery indicator
---|---
| WHO indicator
| Date & Time
| Irregular Heartbeat Symbol
| AF Symbol
| Memory Symbol
| Memory Set
| Heartbeat Symbol
| Pulse rate
| Release air
| Systolic Pressure
| Diastolic Pressure

Battery Installation

Low battery warning:
It is 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 key is pressed.

Replacing the Battery::

1. Press down on latch and lift the cover on the bottom of the monitor.

2. Insert or replace 4x 1.5 V AAA batteries into the battery compartment, ensuring to match the indicated polarity symbols.
   Always use new batteries.

3. Replace the battery cover.

CAUTION:
Risk of explosion if battery is replaced by an incorrect type. Dispose of used batteries according to the instructions.
NOTE: Battery-operated

1. Please properly dispose of the batteries away from small children and heat. Avoid the children accidentally swallow the battery.
2. It is recommended to remove the batteries if the unit will not be used for more than 1 month.
3. Batteries must be disposed of in accordance with local environmental and institutional policies.
4. It is recommended not to use rechargeable, unqualified or different spec battery may damage the device or cause circuit shortcut.

Setting the Date and Time

It is necessary to set the date and time for the unit every time batteries are initially installed or replaced.

To set the date and time, proceed as follows:

• While in power off mode, press and hold the “SET” key for at least 3 seconds to enter Date and Time setting procedure and the Year value will begin to flash.
• Press the “SET” key to advance the display to the desired year, press the “M” key to confirm the year.
• Next, the month will blink. Repeat step 2 to set the month and date, then hours, then minutes.
• After setting the minutes, the unit will automatically exit out of the date/time setting mode and shut off.

Placement of the Pressure Sleeve

It is 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 arm, please modify the instructions  for cuff application to your right arm. Your physician can help you identify which arm is best for you to take measurements from.

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

2. Be seated at a table or desk with your feet flat on the floor.

3. The cuff should not be plugged into the monitor until after the cuff is applied to your arm.
   Note:
   Blood pressure naturally varies from one arm to the other; therefore, measure your blood pressure on the same arm to ensure comparability of the two readings.

4. Position the cuff on a solid surface with the tubing facing up and away from you. The metal ring/bar on the cuff should be to the left of the tubing.

5. Open the cuff by pulling or rolling the bottom of the cuff to the right.
   This should open the cuff without fully unrolling it, creating a cylinder. Do not fully unwrap or unroll the cuff.

6. Insert your left arm into the created cuff cylinder.

7. The bottom edge of the cuff should be positioned approximately one inch above the elbow joint.

8. Reaching underneath your left arm with your right hand, pull the end of the cuff towards your body to tighten the cuff. Wrap and secure the cuff, making sure in place as shown.

9. The cuff should fit comfortably, yet snugly around your arm. You should be able to insert one finger easily between your arm and the cuff.

Note:
If you are not comfortable with applying your cuff, please seek the assistance of another member of your household or work with your physician to practice the cuff application. Incorrectly applied cuffs may result in inaccurate readings.

Measurement of Pulse Rate and Blood Pressure

To set the user and memory zone, proceed as follows:
While in power off mode, press the “SET” key to select user. Confirm your selection with the Power key to turn the power on and start to measure your blood pressure. Or wait for 3 seconds, your selection is then stored and shut off  automatically.

1. Press the Power key to turn the power on. After full display is shown, the values for the last reading will appear on the display. If there is no measurement, the unit displays the value “0”.

2. After the self-test, the blood pressure monitor starts to measure. The cuff will automatically begin to inflate, with the display showing the increasing pressure in the cuff.

3. As the pressure increases, the indicator will increase upwards according to the pressure value on the display.

4. As the cuff inflates, the monitor automatically determines your ideal inflation level. This monitor detects your blood pressure and pulse rate during inflation.
   

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

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

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

8. Press the Power key to turn the unit off and conserve energy and battery life.

The unit will automatically shut-off approximately 2 minutes.
Note:

1. Users are recommended to use BPM835-LJB daily at a fixed time, frequency of usage from 1 to 3 times can be suggested from physician or doctor’s advice.
2. Base on individual body condition the typical operation time takes approximately 30 seconds to 1 minute.

Hypertension Indicator

This unit features our unique Hypertension Indicator. The World Health Organization has established globally accepted standards for the assessment of high or low blood pressure readings. The below chart should be considered only as a  guideline, always consult with your physician or health care professional to interpret your individual results.

Irregular Heartbeat Detector
Your digital blood pressure monitor features an Irregular Heartbeat Detector. This feature allows users to accurately monitor blood pressure even if an irregular heartbeat should occur. When an irregular heartbeat “ ”is detected, the icon  will appear on the display.

Note:
Please consult with your physician or trained healthcare professional for further information regarding an irregular heartbeat and if this symbol appears frequently.

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.

Atrial Fibrillation (AFIB)
This device is a blood pressure monitor that also analyses heart rate variability during measurement.
While in power off mode, switch the “AF” key to select AF mode “ON” or “OFF”. After measurement mode setting, press the “SET” key to select user. Confirm your selection with the Power key to turn the power on and start to measure your blood pressure. Or wait for 3 seconds, your selection is then stored and shut off automatically.

This feature allows users to accurately monitor blood pressure even if atrial fibrillation should occur. When atrial fibrillation is detected, the “ ”icon will appear on the display.

Note:

1. Please consult with your physician or trained healthcare professional for further information regarding an atrial fibrillation if this symbol appears frequently.
2. Even if the AF symbol does not appear, there is still a possibility of Afib.

Memory Function

Recalling Measurements in Memory:
You can recall up to 100 measurements for each user, plus those average values stored measurements in memory to share with your physician or trained healthcare professional.
If you press the M key, the unit will first display the average of last 3 currently stored measurements. Continue to press the M key to successively view the average value of the morning measurements and evening measurements for the  last 7 days will be displayed.
The duration of morning is AM5:00 – AM9:00,
The duration of evening is PM6:00 – PM8:00

If you press the M key again, the measurements will appear on the display from most current to oldest. And the memory number will appear on the display.
All results for a given measurement will display, including measurement results, pulse rate, Hypertension Indicator, Irregular Heartbeat alert, and date/time stamp.

When the number of readings exceeds 100, the oldest data will be replaced with the new record.
Press the Power key to turn the unit off at any time when you check the stored measurements
Clearing Measurements from Memory:
From the memory mode, press and hold down the M key until the display shows CLr. This indicates that all measurements have been erased.

Data Transferring

This product is a Arm 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.
Note:
Please refer to the instruction manual of your smart phone for how to activate the Bluetooth function.
Set Up Process

1. Please determine your mobile phone or computer has BLE4.2.
2. Turn on the BPM19B, when the Bluetooth icon shows on the device, it means BPM19B is under broadcast condition.
3. Please check the connecting condition from your mobile phone or computer. The device name should be “BPM19B”.
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. 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. 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.

FEDERAL COMMUNICATIONS COMMISSION INTERFERENCE STATEMENT
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the 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 receiver is 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.
RF exposure warning
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.

Error Codes

retry again.
Err 01| The cuff is not
fastened correctly,
cuff pressure leakage or inflation too low or Overpressure protection.| The Arm cuff is not fastened properly. Re- apply the cuff, and take a measurement again.
Err 02| Inaccurate reading| Rest a while, relax and retry again.
Err 03| Inflation or deflation fail during the measurement| The Arm cuff is not fastened properly. Re- apply the cuff, and take a measurement again.
Err| Memory error.| Take off batteries to reboot the device, then take another measurement.
| Low batteries| Replace all batteries with new ones.

Troubleshooting

correct position.
Low Battery Symbol appears.| Batteries are drained.| Replace all batteries with new ones.
In colder temperatures batteries have weaker electrical charges.| Warm up the batteries, or use the device in a warmer setting.
Device operation time is
inconsistent.| Different battery brands
have different lite spans.| Use Alkaline batteries and replace all batteries at the same time with same brand batteries.
No reading after measurement.| Batteries are drained.| Replace all batteries with new ones.
Suspicious blood pressure results.| Perhaps the cuff was improperly positioned.| Adjust patient and Arm cuff to measure.
Blood pressure naturally varies throughout the day.| Rest a while, relax and measure again.
Suspicious pulse rate results.| Bodily movement during device use.| Retrain from moving during measurement.
Measurement shortly after exercise or exposure to the outdoors.| Do not take measurements after exercise or coming back from the outdoors.
Power switches off automatically.| System design.| Push the power button again, and then begin measure again.
During measuring, air re- inflates.| It could be a normal action if the user’s blood pressure is higher than the initial pressure value, the device automatically pumps to a higher pressure by 40mmHg each time.| Relax, and try to take a measure again.
I he Arm cuff is not fastened properly.| Check that the Arm cuff is fastened properly and retake the measurement.

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 cleaned carefully using a slightly damp cloth and mild soap solution. Do not completely immerse the cuff in water.

• It is 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.
  And store it at appropriate condition.

Technical Specification

• Measuring range :
  Blood Pressure : 40~255 mmHg
  Pulse Rate : 40~199 beats/min

• Calibration Accuracy:
  Blood Pressure : ± 3 mmHg
  Pulse rate : ± 4% of reading

• Operating environment : 10°C~40°C
  15% to 85% relative humidity (non-condensing)
  700-1060 hPa ambient pressure

• Storage/ Transportation environment : -20 to 50 °C
  15% to 85% relative humidity (non-condensing) 700-1060 hPa ambient pressure

• Power Source : 4 x 1.5V LR03 (AAA) alkaline

• Weight : approx. 222g (exclude batteries) +/- 5%

• Dimensions : approx. 138 mm x 103 mm x 54 mm (L x W x H)

• Cuff circumference (M/L Size) : approx. 22 ~ 42 cm (9” ~ 17”)

• Lifetime : 3 years

• Expected service life : 10,000 measurements

Note: After 3 years life time or 10,000 measurements, device material may experience degradation, measurement accuracy may vary.

EMC Tables

BPM835-LJB is intended specified below. The customer sure that it is used in such| for use in the electromagnetic environment or the user of BPM835-LJB must make an environment.
---|---
Guidance and manufacturer’ s declaration| – Electromagnetic emissions
Phenomenon| CISPR 11
Group 1 Class A (Not BLE Function)
Group 2 Class A (With BLE Function)| CISPR 11
Group 1 Class B (Not BLE Function)
Group 2 Class B (With BLE Function)
Conducted and radiated RF MISSIONS| Not applicable (Note: Power or DC Input) Only the to be tested| by Battery AC input needs|
Harmonic distortion| Not applicable (Note: Power Only the| by Battery or DC Input) AC input needs to be tested
Voltage fluctuations and flickering| CISPR 11
Group 1 Class A (Not BLE Function) Group 2 Class A (With BLE Function)
a)The equipment is suitable for use in Home Health Professional Health Care Environments limited to respiratory treatment facilities in hospital or clinics. acceptance limits of Group 1 Class B (CISPR 11) have and applied. The equipment is suitable for use in the environments when directly connected to the Public
b)The test is not applicable in this environment unless EQUIPMENT and ME SYSTEM used will be connected MAINS NETWORK and the power input is otherwise the Basic EMC standard.| Environments and patient rooms and
The more restrictive
been considered
mentioned
Mains Network. the ME
to the PUBLIC within the scope of
Guidance and manufacturer’ s declaration – Enclosure port| – Electromagnetic immunity
Phenomenon| Basic EMC standard or test method| Immunity test| levels
Professional healthcare facility environment| HOME HEALTHCARE ENVIRONMENT
ELECTROSTATIC| IEC 61000-4-2| ± 8kV contact
DISCHARGE| | ± 2 kV, ±4kV ±, ±8 kV, ±15 kV air
---|---|---
Radiated RF EM fields| IEC 61000-4-3| a)| 10 V/m b) 80MHz – 2.7 GHz 80% AM at 1kHz
Proximity fields| IEC 61000-4-3| COMPLIANT
from RF wireless| | NOTE: Further information about
communications| | distances to be maintained between
equipment| | portable and mobile RF communications equipment
| | (transmitters) and the BPM835-LJB can be requested from supplier using the contact information provided in this manual. However, it is advisable to keep the equipment at an
adequate distance of, at least, 0.5 m from mobile phones or other RF communications transmitters to minimise possible interference.
RATED power| IEC 61000-4-8| 30 A/m c)
frequency magnetic fields.| | 50 Hz or 60 Hz
a)The equipment is suitable for use in Horne Health Environments and
Professional Health Care Environments limited to patient rooms and
respiratory treatment facilities in hospital or clinics. The more restrictive
IMMUNITY acceptance limits have been considered and applied.
b)Before modulation is applied.
c)This test level assumes a minimum distance of at least 15 cm between
the ME EQUIPMENT or ME SYSTEM and sources of power frequency magnetic fields.

Explanation of Symbols

denotes the compliance of Regulation (EU) 2017/745
| Medical Device
| Manufacturer
| Authorized representative in the European Community
| Date of manufacture (YYYY-MM-DD or YYYY-MM)
| Batch code (YYMMWWWW)
SN| Serial number (YYMWWWXXXXX)
**| Keep dry
| Temperature limit
| Humidity limitation
| Atmospheric pressure limitation
| Caution
| 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. WEEE 2012/19/EU
Directives
RoHS| This product fulfilling the requirements of the RoHS Directive
2011/65/EU.
REACH| This product fulfilling the requirements of the REACH
Directive EC 1907/2006 and its amendments, do not contain
Substances of Very High Concern in concentration above
the limit of 0.1 %. No substance(s) is/are present in the parts
of the product above the concentration of 0.1 % weight by
weight.
| Stand-by
| Device classification type BF
IP 22| This product meets the basic safety and essential performance requirements indicated in  the IP22 conditioning test (protection against solid foreign objects of 12.5mm ∅ and  greater and against vertically falling water drops when enclosure tiled up to 15°)
| The empty, completely flat batteries must be disposed of through specially designated  collection boxes, recycling points or electronics retailers. You are legally required to dispose of the batteries.
| Importer
| Distributor
#**| Model Number
| Country of Manufacturer
| Unique Device Identifier
| Keep away from sunlight

BPM835-LJBP-22628AV
2022-12-22

References

• Infrared Thermometer Supplier - AViTA Corporation

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