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

AOJ MEDICAL AOJ-33A 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 transportation, 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:

Symbols, marks and their meaning

| Warning information,refer to the attached document
| BF-type anti-shock degree for the application part
|

Comply with local regulations

---|---
| Consult the instructions for use
| Keep dry
| Low voltage prompt
| Keep out of the sun
| Vertical upward
IP22| The device is protected against splashing water. Water splashed against the enclosure from any direction shall have no harmful effects.
RoHS| RoHS mark
| CE mark
| Manufacturer
| Date of manufacture
| Serial number
| Lot number
| EU authorized representative

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

1. Main Bod
2. (2)Display Outline

1. Systolic Blood Pressure Icon
2. Diastolic Blood Pressure Icon
3. Pulse Rate Icon
4. Pulse Rate Value
5. “Irregular Heartbeat” Indicator
6. Blood Pressure Unit
7. Mute/Unmute Indicator
8. Battery Indicator
9. “User 1” Icon
10. “User 2” Icon
11. “User (guest)” Icon
12. “Motion” Indicator
13. Memory Group
14. “Cuff Worn” Indicator
15. Memory Icon
16. “Average/Triple Measurement” Indicator
17. Time
18. WHO Blood Pressure Indicator
19. Systolic Blood Pressure Value
20. Diastolic Blood Pressure Value

3-color Backlit Indicator

• Green Indicator Light for Normal
• Yellow Indicator Light for Mild High Blood Pressure or Hypertension
• Red Indicator Light for High Blood Pressure or Hypertension

Systolic Blood Pressure(mmHg)| Diastolic Blood Pressure(mmHg)| Color of Reading| Hierarchical Relationship
---|---|---|---
≥160| ≥100| Red| and (or)
140-159| 90-99| Yellow| and (or)
90-139| 60- 89| Green| and (or)
<90| <60| Yellow| and

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

1. To Select User
   In standby mode, press the “ ” button to enter the user group selection interface. Then press the “ ” button again to switch and select user groups.

2. Year/Month/Date Setting
   In standby mode, press “ ” for about 3 seconds to enter the date setting, and “year” will flash. Press “ ” to adjust to the desired year, and then press “ ” to confirm the selection. When the “year” is set, it will automatically enter the month setting. At this time, the “month” icon will flash. You can switch to the desired value by pressing the ” ” button. Follow the same step to set “date”, “hour”, and “minute”.

3. Voice On/Off Setting (for voice version only,optional function)
   After the time setting is finished, it will automatically enter the voice setting (the screen will display “SP”). Press “ ” button to turn on or turn off the sound. “ON” means turn on the sound, “OFF” means turn off the sound, and press ” ” button to confirm the selection.

4. Unit Display Setting
   In standby mode, keep pressing “ ” button for about 3 seconds to enter the unit selection. Press “ ” to switch between mmHg and kPa, and then press “ ” to confirm the selection. The default unit is mmHg.

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 continuous measuring.

2. Wearing the Cuff Correctly

3. Unroll cuff. Place your arm inside it. (We strongly 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 for 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 supported.
   • 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.
   • 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 ” ” 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. Each measured value is stored automatically under the appropriate “User” group. This device can store up to 120 sets of measurements for each user. (Note: There is no memory for “Guest”.) Once the memory log is full, old values are refreshed with new ones.

10. In standby mode, press the “ ” button once and the device will display the average value of the blood pressure measured for the first three times. Press the “ ” button again, the first memory will be displayed. Press the “ ”  button again and the rest memories will be displayed one by one.

11. Delete memory
    Keep pressing the ” ” button for 3 seconds to delete measurements stored on the device and the ” ” icon will appear on the screen.

12. Self check for cuff strap
    The “ ” icon is always displayed on the screen when the cuff is wore correctly. When the cuff is wore too loosely, the “ ” icon will always flash to remind you. If the” ” icon is flashing all the time, please press the “  ” button to stop the measurement.

13. “Keep Still” indication
    The “ ” icon flashes when the body moves during the measurement, which may cause incorrect measurement results. Please re-measure it.

Contraindications, 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, computer 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.

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 cross-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.

in 12 seconds.

Er H| The inflation reaches 295mmHg, and

it deflates automatically after 20 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

There is no

|  |
display after the power

switch is

| The battery is depleted.| Recharge the device till the ”     ” indicator stops flashing.
pressed|  |

Unable to measure due to

| ****

Whether the arm is moved when pressurization

| ****

Keep your arm and body still

display error|  |
Whether you talk during measurement| Keep quiet while measuring the blood pressure

Air leakage

| ****

The airbag of the

| Please contact the dealer to replace with
of cuff| cuff is ripped.| 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 monitor clean and tidy, helpful to prolong the service life of Blood Pressure Monitor.

– If the host 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 using the device.

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

Specifications

Model

| ****

AOJ-33A

---|---
Display| LED Screen
Measuring Method| Oscillometric
Measuring Part| Upper arm
Pneumatic Pressure Measuring Range| 0~295 mmHg (0~39.3 kPa)
---|---
Maximum Pressure Protection| 295 mmHg (39.3 kPa)

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

| It can be used for 3 users (user 1, user 2 and guest mode).

2 users, 120 sets each and guest mode without memory.

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

| 123 mm (L) x 59 mm (W) x 28mm (H) (4.84 inches x 2.32 inches x1.10 inches)
Screen Size| 75mm (L) x 35 mm (W) (3.2 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 Degree

| Type BF
Protection Against 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 designated temperature and humidity range, it will not be used properly.
Humidity Condition| 15%-90% RH
Atmospheric Condition| 70kPa- 106kPa

Transportation and Storage Environment

| Avoid strong impact, direct impact, exposure or rain during transportation. The device shall be stored indoors at the temperature of -20℃~55℃ and the relative humidity of 10%~93%,atmospheric condition:

70kPa-106kPa without corrosive gas and with good ventilation.

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 rm 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/flick er

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 kV contact

±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( MHz)

| ****

Band (MHz)

| Service| 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| 380

– 390

| TETRA

400

| Pulse

modula tion

18 Hz

| 1,8| 0.3| 27| 27|
450| 430

– 470

| GMRS

460, FRS 460

| FM

± 5 kHz deviation 1 kHz sine

| 2| 0.3| 28| 28|
 | 710| 704| LTE

Band 13,17

| Pulse modula tion 217 Hz| 0,2| 0.3| 9| 9|
–|  |  |  |  |
745|
787|  |  |  |  |
780|  |  |  |  |  |
810| 800| GSM 800/900, TETRA

800, iDEN 820, CDMA 850, LTE

Band 5

| Pulse modula

tion 18 Hz

| 2| 0.3| 28| 28|
–|  |  |  |  |
870|
960|  |  |  |  |
930|  |  |  |  |  |
1720|  | GSM 1800;

CDMA 1900; GSM 1900; DECT; LTE

Band 1, 3,

4, 25; UMTS

| Pulse

modula

| 2| 0.3| 28| 28|
 | 1700

–

| tion

217 Hz

|  |  |  |  |
1845|
 | 1990|  |  |  |  |  |
1970|  |  |  |  |  |  |
2450|  | Blueto

oth,

| Pulse

modula

| 2| 0.3| 28| 28|
 |  | WLAN,| tion|  |  |  |  |
 | 2400

–

| 802.11

b/g/n,

| 217 Hz|  |  |  |  |
 | 2570| RFID

2450,

|  |  |  |  |  |
 |  | LTE|  |  |  |  |  |
 |  | Band 7|  |  |  |  |  |
5240|  | WLAN

802.11

a/n

| Pulse

modula tion 217 Hz

| 0,2| 0.3| 9| 9|
 | 5100|  |  |  |  |
 | –|  |  |  |  |
5500|
5800|  |  |  |  |
5785|  |  |  |  |  |

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.
3. The device has been evaluated to meet general RF exposure requirement. The device can be used in portable exposure condition without restriction.

Note: This equipment hasbeen testedand found tocomply withthelimits 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, thereis no guarantee that interference will not occurin 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.

Shenzhen AOJ Medical Technology Co., Ltd. Room 301&4F, Block A, Building A, Jingfa Intelligent Manufacturing Park, Xiaweiyuan, Gushu Community, 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
Address: Heerdter Lohweg 83, 40549 Düsseldorf, GERMANY Tel: 0049 179 5666 508
E-mail: EU-Rep@share-info.com

References

• Info.com – The Smarter Way to Search The Web
• Shenzhen AOJ Medical Technology Co., Ltd - A Product-focused Provider of Medical Device Supply Chain Services

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