AOJ MEDICAL AOJ-33B Arm Blood Pressure Monitor Instruction Manual

AOJ MEDICAL AOJ-33B Arm Blood Pressure Monitor

Thank you for purchasing the Arm Blood Pressure Monitor. The device uses the oscillometric method of blood pressure measurement. It is intended for professional and domestic use in monitoring diastolic and systolic blood pressure and pulse rate.
The device is suitable for use at home, at work, and on vacation. It is also suitable for daily blood pressure checks.

Unpacking Inspection

Before use, please open the package carefully and check whether all the parts are available according to the following packing list and whether the parts are damaged during transporta- tion, and then install and operate in strict accordance with the manual.

Packing List

Safety Precautions

The warnings and illustrations shown in the manual are intended to enable you to use the device safely and correctly, thus preventing harm to you and others, specific meanings of which are shown as follows:

Product Composition
This device is composed of the main body and cuff.

Intended Use / Instructions for Use
The Arm Blood Pressure Monitor is intended to measure the systolic pressure and diastolic pressure, as well as the pulse rate of adult person via non- invasive oscillometric technique at medical facilities or at home.

Contraindication
No known contraindication existing.

Product Parts

Main Body

Preparation

Type-C Charging
Please check the device’s power before using it. When the battery runs out, please use the manufacturer-provided Type-C Charging Cable to charge the device till the indicator stops flashing.

Function Setting

Voice On/Off Setting (for voice version only, optional function) In standby mode, press and hold the “POWER” button,
and then simultaneously press the “NOTE ” button for about 3 seconds to enter the voice setting mode. Then press “POWER” button to confirm the selection (as shown in the figure below); “VOICE ON ” means turn on the sound, “VOICE OFF” means turn off the sound.

How to Take Proper Measurements

1.  Preparation before measurement

   • Always measure in the same arm (generally the left arm).
   • Remain still and keep quiet during measurement. –Relax as much as possible and do not talk during measurement.
   • Measure your blood pressure at about the same time every day.
   • Do not measure right after physical exercise or a bath. Rest for 20 to 30 minutes before taking the measurement.
   • Readings under the conditions listed below may affect results:
     Within an hour after dinner, after having wine, coffee, tea, sports; talking, being nervous, being in unsteady mood, bending forward, moving, room temperature dramatically changing during measuring; inside a moving vehicle, repeated and contin- uous measuring.

2. Wearing the Cuff Correctly

3. Unroll cuff. Place your arm inside it. (We strong- ly recommend to use your left arm.)

4. Make sure that the device’s screen is positioned on your inner arm as illustrated in the diagram. The bottom edge of the cuff should be 0.79-1.18 inches (2 to 3 cm) above the inside elbow.

5. Tighten the cuff around your arm, so it can not move around your arm.
   Note: Repeated measurement may result in blood congestion in the arm, which will affect the measurement result. To avoid this situation, we advise that you can raise the left hand and hold the fist several times, or take off the cuff and rest for at least 2-3 minutes before taking the measurement.

6.  Measurement Tips

   • To take a measurement, you need to be relaxed and comfortably seated in a room with a comfortable temperature.
   • Sit in a comfortable chair with your back and arm support.
   • Keep your feet flat and your legs uncrossed.
   • The device should be placed on your inner arm at the same level as your heart, with the arm resting comfortably on a table.
     Note: Please use only the manufacturer-provided cuff, as it has passed all required clinical trials.
     Any replacement of the original components with materials not specified or provided by the manufacturer may result in measurement errors.

7. Taking a measurement
   Press the “power” button and the monitor will begin to inflate. Please do not move or talk during the measurement.
   Note: If you feel uncomfortable during the measurement, press the ” ” button immediately to stop measure. When the air pressure is filled to a certain value, the value on the display screen will slowly drop at a certain speed, and the heartbeat symbol will flash. After the measurement is completed, the systolic pressure, diastolic pressure, and pulse measurements will be displayed on the screen.
   Note: Consult your doctor if unexpected readings are obtained.

8. Memory function

9. The device can be used for 1 user. This device can store up to 240 sets of measurements. Once the memory log is full, old values are refreshed with new ones.

10. In standby mode, press the “note” button once and the device will display the average value of the blood pressure measured for the first three times. Press the ” note” button again, the first memory will be displayed. Press the “note” button again and the rest memories will be displayed one by one. Group number, SYS and DIA, and pulse rate are displayed on the screen alternately.

Delete memory
In standby mode, press the “NOTE” button once and the historical measured value is displayed on the screen. Then keep pressing the “NOTE” button for 3 seconds to delete measurements stored on the device and the “NOTE” icon will appear on the screen.

Precautions, Warnings and Prompt Instructions

• No maintenance or servicing when using.

• Do not operate when charging.

• Dispose of the monitor when its service life is reached. Follow local regulations regarding the disposal of such products.

•  Maintenance should be done by the operator as suggested.

• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30cm (12 inches) to any part of the this device,
  including cable specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

• When ambient temperature is less than 5℃ or higher than 40℃, the time from minimum storage temperature to use is at least 1 hour; The time from maximum storage temperature is at least 2
  hour.

• DO NOT use this monitor on infants, toddlers, children or persons who cannot express themselves.

• DO NOT take medicine based on readings from the device. Contact your physician for specific information about your blood pressure. The user should not self-diagnose or self-medicate per
  measured results. Kindly adhere to the instructions of your physician or health provider.

• DO NOT use this monitor on an injured arm or an arm under medical treatment.

• DO NOT use the device while you are on an intravenous drip or blood transfusion.

•  DO NOT use this monitor in areas containing high frequency (HF) surgical equipment, magnetic resonance imaging (MRI) equipment, computerized tomography (CT) scanners. This may result in
  incorrect operation of the monitor and/or cause an inaccurate reading.

• Consult with your physician before using this monitor if you have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, arterial sclerosis, poor Perfusion, diabetes,
  pregnancy, pre-eclampsia or renal disease. NOTE that any of these conditions in addition to patient motion, trembling, or shivering may affect the measurement reading.

• NEVER diagnose or treat yourself based on your readings. ALWAYS consult with your physician.

• To avoid strangulation, keep the type C cable away from infants, toddlers and children.

• Stop using this monitor and consult with your
  physician if you experience skin irritation or discomfort.

• Consult with your physician before using this monitor on an arm where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present because of temporary interference to blood
  flow which could result in injury.

• Consult with your physician before using this monitor if you have had a mastectomy.

• Consult with your physician before using this monitor if you have severe blood flow problems or blood disorders as cuff inflation can cause bruising.

• DO NOT use this monitor for any purpose other than measuring blood pressure and pulse rate.

• DO NOT disassemble or attempt to repair this monitor or other components. This may cause an inaccurate reading.

• DO NOT use in a location where there is moisture or a risk of water splashing this monitor. This may damage this monitor.

• DO NOT use this monitor in a moving vehicle such as in a car.

•  DO NOT drop or place this monitor to strong shocks or vibrations.

• DO NOT use this monitor in places with high/low humidity and temperatures.

• Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment
  should be observed to verify that they are operating normally.

• Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

• If continuous measurement, monitor generated heat transits to cuff, it may lead cuff temperature reach about 42℃, lower than 43℃.When you feel uncomfortable or overheating on cuff touched part, please stop measurement immediately,and take cooling on the arm part.

Common Q & A on Blood Pressure

Q1: Why is the blood pressure value obtained at home lower than that obtained at the hospital?

• The blood pressure difference between home and hospital measurements is about 20 mmHg 30 mmHg (2.7 kPa – 4.0 kPa). This is because individuals tend to be more relaxed at home than at the hospital.
• Also, when the device is placed at a position over the heart, the blood pressure value tends to be much lower than it actually is. Ensure the device is positioned right at the heart level.

Q2: Why is the blood pressure value obtained at home higher than that obtained at the hospital?

• The anti-hypertensive drug the patient might be using has lost its efficacy. Kindly adhere to your doctor’s instructions.
• The cuff might not be in the correct position. If the cuff is not placed right, no arterial pressure value will be obtained, and the blood pressure value might be much higher than it is. Therefore, properly position the cuff.
• The cuff is not tight enough. If the cuff is loose, the compression force might fail to transmit to the artery, causing the blood pressure value to be much higher than it is. Therefore, re-adjust and tighten the cuff further.
• The patient is not sitting correctly during measurement. Slouching, tilting, bending, and sitting ross-legged are not encouraged while taking blood pressure measurements due to increased abdominal pressure or the arm position being below the heart. Kindly take readings in the correct posture.

Q3: When can I obtain better measurements?
Measurements are best taken in the mornings right after you urinate or when your mind and body are stable. We recommend taking readings at the same time of the day, every time.

Abnormal Phenomena and Handling

If the measurement is abnormal, any of the following symbols may appear. Kindly use the recommended method for measurement.

seconds.
Er 1| The pulse rate is not detected correctly.
Er 2| Motion or disturbance during measurement.
Er 3| Abnormal test result.
Er 23| SYS value reads lower than 57mmHg.
Er 24| SYS value reads higher than 255mmHg.
Er 25| DIA value reads lower than 25mmHg.
Er 26| DIA value reads higher than 195mmHg.

Troubleshooting

The battery is depleted.

| Recharge the device till the ”  ” indic- ator stops flashing.
Unable to Measure Due

To Display Error

| Whether the arm is moved when pressur- ization| Keep your arm and body still.
Whether you talk during measurement| Keep quiet while measuring the blood pressure.

Air Leaka- ge of Cuff

| ****

The airbag of the cuff is ripped.

| Please contact the dealer to replace with a new cuff. Don’t change the cuff by yourself.
---|---|---
If the blood pressure still cannot be measured after trying the above-stated solutions, please contact the dealer. Do NOT attempt to disassemble the device by yourself.

Cleaning and Disinfection

Cleaning
The device can be cleaned with a soft, clean cloth dampened with a small amount of neutral detergent or water.
Do not use corrosive cleaning agents, and take care not to immerse any part of the monitor in any fluid.
It is suggested to clean once every week.
Complete the cleaning in 3min each time. The number of repeated cleaning each time shall not exceed 3 times.

Disinfection
Recommended Disinfecting Agent 70% Isopropanol solution Steps:

1. Carefully wipe the device with a soft, clean cloth dampened with a small amount of the above disinfectant, and dry immediately with a soft,  clean, dry cloth.
2. The body of the device can also be cleaned with a soft, clean cloth dampened with a small amount of 75% medical-grade alcohol for disinfection. Do not disinfect through methods like high-temperature steam or ultraviolet radiation. These might damage the device and reduce its service life.
   It is suggested to disinfect the monitor before and after use each time. Each time of disinfection shall be completed within 1min. The number of repeated disinfection each time shall not exceed 2 times.

Disposal
Dispose of your monitor, other components and optional accessories according to applicable local regulations.
Unlawful disposal may cause environmental pollution.

Notes

• Do not bend or crease the air tube excessively.
• Do not store the monitor or its components:
• If the monitor or its parts is wet in locations with extreme temperatures, humidity, direct sunlight, dust, or corrosive gases.
• in areas with a high risk of vibrations or shocks.

Upkeep and Maintenance

– Always keep the surface of the device clean and tidy, helpful  to prolong its service life.

– If the device is dirty, please wipe with a dry soft cloth. If the dirt cannot be eliminated easily, wipe with a soft cloth stained with water or neutral detergent, and then dry with a dry cloth.

– No maintenance or maintenance required when operating the device.

Do not allow water or other liquids to flow into the device.

Specifications

Measurement Range

| ****

Blood Pressure Value

| SYS: 57-255 mmHg

(7.6-33.4 kPa);

DIA: 25-195 mmHg

(3.33-26 kPa);

Pulse Rate| 40-199 bpm

Accuracy

| Blood Pressure Value| ****

±3 mmHg (±0.4 kPa)

Pulse Rate| about ±5%
Memory| 1 user with 240 memory sets
---|---
Power Source| 3.7V Rechargeable Lithium Battery
Charging Method| Type-C Charging Port; Charging Voltage: DC 5V

Charging Time: 2 hours for full charge

Low Battery| When the power is lower than 3.4V, the device will be turned off.
Dimension| 125 mm (Length) x 48 mm (Width) x 28 mm (Height) (49.21 inches x 18.9 inches x 11.02 inches)
Screen Size| 46.5 mm (Length) x 16 mm (Width) (1.8 inches)
Cuff Size| 22-42 cm (8.66-16.53 inches)
Weight| About 225g
Anti Electronic Shock Type| Internal Power Supply
Auto Power-off| 1 Minute Without Operation
Anti Electronic Shock Shock Degree| Type BF
Protection Ag- ainst Harmful Ingress of Water or Particular Matter| IP22
Service Life| 5 years
Protection Against Electric Shock| Internally powered supply
Operating Environment| Temperature Condition| 5℃-40℃| If stored or used beyond the desi- gnated tempera- ture and humidity range, it will not be used properly.
Humidity Condition| 15%-90% RH
Atmospheric Condition| 70kPa- 106kPa

Appendix 1 EMC Information

Guidance and manufacturer’s declaration – Electromagnetic emission

Arm Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the Arm Blood Pressure Monitor should assure that it is used in such an environment.
Emissions| Complian ce| Electromagnetic environment

– guidance

RF emissions CISPR 11| Group 1| The Arm Blood Pressure Monitor uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11| Class B| The Arm Blood Pressure Monitor is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic

emissions IEC61000-3-2

| N.A.|
Voltage fluctuations/ flicker

emissions IEC61000-3-3

| N.A.
Guidance and manufacturer’s declaration

– Electromagnetic immunity

The Arm Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of Arm Blood Pressure Monitor should assure that it is used in such an environment.
Immunity test| IEC 60601

test level

| Compliance level
Electrostatic discharge (ESD) IEC 61000-4-2| ±8kV contact

±2 kV, ±4kV, ±8 kV,

±15kV air

| ±8 kVcontact

±2 kV, ±4 kV,

±8 kV, ±15 kV air

Electrostatic discharge (ESD) IEC 61000-4-2| ±8 kV contact

±2 kV, ±4 kV, ±8 kV,

±15 kV air

| ±8 kV contact

±2 kV, ±4 kV, ±8 kV,

±15 kV air

Electrical fast transient/burst IEC 61000-4-4| Not applicable| Not applicable
Surge

IEC 61000-4-5

| Not applicable| Not applicable
Voltage dips, short interruptions and voltage variations on power supply

input lines IEC 61000-4-11

| Not applicable| Not applicable
Power frequency Magnetic field IEC 61000-4-8| 30A/m, 50/60Hz| 30A/m, 50/60Hz
Conducted RF IEC61000-4-6| Not applicable| Not applicable
Radiated RF IEC61000-4-3| 10 V/m

80 MHz – 2,7 GHz

80 % AM at 1 kHz

| 10 V/m

80 MHz – 2,7 GHz

80 % AM at 1 kHz

NOTE: UT is the a.c. mains voltage prior to application of the test level
Guidance and manufacturer’s declaration – electromagnetic Immunity

The Arm Blood Pressure Monitor is intended for use in the electromagnetic

environment specified below. The customer or the user of the Arm Blood Pressure Monitor should assure that it is used in such an environment.

Radiate d RF IEC6100 0-4-3

(Test specifica tions for ENCLO SURE PORT IMMUNI

TY to RF

wireless commun ications equipme nt)

| Test Frequ ency( M Hz)| Ba nd (M

Hz

)

| Servic e| Modula tion| Max

.

Pow er (W)

| Di st an ce (m

)

| IEC 60601-1-2

Test Level (V/m)

| Comp liance level (V/m)
385| 38

0-3

90

| TETRA 400| Pulse modula tion

18 Hz

| 1,8| 0.3| 27| 27
450| 43

0-4

70

| GMRS 460, FRS 460| FM

± 5 kHz deviatio n

1 kHz sine

| 2| 0.3| 28| 28
| 710| 70

4-7

87

| LTE

Band 13,

17

| Pulse modula tion 217 Hz| 0,2| 0.3| 9| 9
745
780
810| 80

0-9

60

| GSM 800/90

0, TETRA 800, iDEN 820, CDMA 850,

LTE

Band 5

| Pulse modula tion

18 Hz

| 2| 0.3| 28| 28
870
930
1720| 1

70

0 –

1

99

0

| GSM 1800; CDMA 1900; GSM 1900; DECT; LTE

Band 1, 3,

4, 25; UMTS

| Pulse modula tion 217 Hz| 2| 0.3| 28| 28
1845
1970
2450| 2

40

0 –

2

57

0

| Blueto oth, WLAN, 802.11

b/g/n, RFID 2450, LTE

Band 7

| Pulse modula tion 217 Hz| 2| 0.3| 28| 28
5240| 5

10

0 –

5

80

0

| WLAN 802.11

a/n

| Pulse modula tion 217 Hz| 0,2| 0.3| 9| 9
5500
5785

NOTE：

• Optional AC adaptor should comply with the requirement of IEC 60601-1 standard.

• Use only the exclusive AC adapter specified by authorized dealers.
  Other AC adapter may vary in output voltage and polarities and may represent a risk on your life and damage the device.

• When the AC adapter is in use, the device does ot draw power from batteries.

FCC Caution

Any changes or modifications not expressly approved by the party responsible for compliance 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.

FCC RF Radiation Exposure Statement:

1. This Transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.
2. This equipment complies with RF radiation exposure limits set forth for an uncontrolled environment.
   The device has been evaluated to meet general RF exposure requirements. The device can be used in portable exposure conditions without restriction.

Manufacturing Park, Xiaweiyuan, Gushu Communit y,
Xixiang Street, Bao’an District, 518126 Shenzhen, CHINA
Email: info@aojmedical.com
Website: https://www.aojmedical.com
Tel : 86-755-2778 6026
Made in China
Share Info GmbH
Heerdter Lohweg 83, 40549 Düsseldorf, Germany
Tel:0049 179 5666 508
E-mail: EU-Rep@share-info.com
Manual Version: A0
Software version: V1.0
Revision date:2021-12
AOJ-Wl-33B-007

References

• Info.com – The Smarter Way to Search The Web
• A Leading Supplier of Infrared Thermometer and Blood Pressure Monitor
• Shenzhen AOJ Medical Technology Co., Ltd - A Product-focused Provider of Medical Device Supply Chain Services

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