Oklar Fully Automatic Upper Arm Blood Pressure Monitor
Model Number: C02
USER'S MANUAL
Manufacturer: Shenzhen Jamr Technology Co., Ltd.
Address: A101-301, D101-201, Jamr Science & Technology Park, No. 2 Guiyuan Road, Guixiang Community, Guanlan Street, Longhua District, 518100 Shenzhen, PEOPLE'S REPUBLIC OF CHINA
Product Dimensions: Finished size 90x130mm, Broken size 630x130mm. Material: 80G writing paper, double-sided folding.
LEGAL DISCLAIMER
This blood pressure monitor is an Over-the-Counter (OTC) device. The measurements are for informational purposes only and are not intended to diagnose, treat, cure, or prevent any disease or health condition. The model number of this device is C02. It has been approved by FDA with 510K number: K200437. For more accurate measurement results, please follow the correct measurement requirements.
INTRODUCTION
The device is a fully automatic blood pressure monitoring device. It is intended to measure systolic and diastolic blood pressure, as well as pulse rate, using the oscillometric method. The device is suitable for adults aged 12 years and older and is intended for over-the-counter use in both medical facilities and at home.
SAFETY INFORMATION AND PRECAUTIONS FOR USE
- Read all instructions.
- This device is intended for use on the upper arm.
- To ensure accurate readings, sit properly, do not talk, and avoid using the device while your arm is resting on a hard surface.
- This device is intended for home use to measure systolic and diastolic blood pressure. It can only be used by one person at a time.
- Do not use this device for any conditions other than those for which it is intended. Consult your physician if you have any health conditions, such as hypertension, diabetes, vascular disease, or conditions affecting circulation.
- Do not change the operation or application of this measurement device.
- Directly applying the cuff and inflating it without proper measurement may cause injury.
- Do not use this device if the cuff is damaged or if the air plug is not properly inserted.
- If you feel discomfort or pain during measurement, stop the measurement immediately.
- If you experience any adverse reactions, consult your physician.
- Clean the device with a soft cloth and mild detergent. Do not use abrasive cleaners.
- Remove the batteries if the device is not used for an extended period.
- Ensure that the batteries are disposed of properly according to local regulations.
DEVICE
Cuff: The cuff is designed for upper arm measurement. It has a cuff self-checking function.
Display: Features a large LED display with LED background light.
Diagram Description: The image shows the blood pressure monitor device with the cuff attached to the upper arm. The display shows numerical values for systolic, diastolic, and pulse rate. Buttons for Power, Start/Stop, Memory, and Set are visible.
Ports: Includes an AC adapter port for optional external power.
Diagram Description: The image shows the cuff with a connection port for the air tube. Another image shows the main unit with ports for the cuff and AC adapter.
External AC Adapter: Not included.
The symbols on the LED Display
- User A ?
- User B ?
- Movement error symbol ⚠
- Mute symbol ?
- Cuff self-detecting function ✔️
- AM symbol ☀️
- Low battery symbol ?
- Heartbeat symbol (Flashes during measurement) ❤️
- WHO function symbol ?
- NO. symbol #️⃣
- Average value symbol ?
- Date symbol ?
- Pulse symbol ❤️?
- Hour symbol ⏰
- Minute symbol ⏱️
- Systolic blood pressure ⬆️
- Diastolic blood pressure ⬇️
- Month symbol ?️
Features of Model C02
- Cuff self-checking function ✔️
- Double users: 2 x 120 sets memory ?
- Average value function ?
- Low battery display ?
- WHO function ?
- Auto power-off ?
- External power adapter support ?
- Time stamp in memory ?
SYSTEM SETUP
- Setting the User: Press the SET button to select User A or User B. Press the MEM button to view history.
- Setting the Year/Month&Date/Time: Long press the SET button for more than 6 seconds to enter setting mode.
- Setting the Year: The initial year is 2022. When the year display flashes, press the MEM button to increase the year. Press SET to confirm.
- Setting Month/Date: Initial Month/Date is 01/01. When the Month display flashes, press the MEM button to increase the month. Press SET to confirm. Repeat for the date.
- Setting Time: When the hour display flashes, press the MEM button to increase the hour. Press SET to confirm. Repeat for the minute.
- Record Delete: To delete all memory, press and hold the MEM button for three seconds while the device is off. Alternatively, remove the batteries for a period to reset memory.
MEASUREMENT
Prepare for Measurement
- Sit comfortably in a chair with your feet flat on the floor. Rest your arm on a table or cushion so that the cuff is at heart level.
- Relax for 5-10 minutes before taking a measurement.
- Avoid eating, drinking alcohol, smoking, or exercising for at least 30 minutes before measurement.
- Ensure the cuff is applied correctly and the air plug is inserted securely.
Diagram Description: An illustration shows a person sitting correctly for a blood pressure measurement, with their arm supported at heart level and the cuff applied properly.
Taking the Measurement
- Press the START/STOP button to begin the measurement.
- The cuff will automatically inflate. Remain still and do not talk during the measurement.
- The cuff will deflate automatically once the measurement is complete.
- The systolic pressure, diastolic pressure, and pulse rate will be displayed on the screen.
Position Yourself
Sit comfortably with your back supported and feet flat on the floor. Ensure your arm is relaxed and at heart level. Avoid crossing your legs.
Diagram Description: An illustration shows the correct posture for taking a blood pressure reading, emphasizing relaxation and proper arm positioning.
Start the Measurement
- Select User 1 or User 2 by pressing the SET button.
- Press the START/STOP button to begin the measurement.
- The device will automatically inflate the cuff and display the measurement results.
- After measurement, the device will automatically turn off after a period of inactivity, or you can press the START/STOP button to turn it off.
Error Codes and Troubleshooting
| Error Code / Symbol | Description | Solution |
|---|---|---|
| Weak battery or improper placement ? | The battery power is low or the batteries are not inserted correctly. | Replace both batteries with new ones. Check the battery installation for proper polarity. |
| Sensor abnormal ⚠ | The cuff pressure is not drained, or the sensor has an issue. | Ensure the cuff is fully deflated and measure again. If the error persists, contact customer support. |
| Monitor could not detect pulse wave or cannot calculate blood pressure data | The cuff is not applied correctly, or there's an issue with pulse detection. | Apply the cuff correctly and measure again. If the error persists, contact customer support. |
| Measurement result is abnormal | Occasional abnormal readings or consistently abnormal readings. | Measure again. If the error persists, consult your physician. |
| Too loose cuff or air leakage | The cuff is too loose, or there is an air leak in the cuff or tubing. | Tie the cuff correctly and ensure the air plug is properly inserted. Check for cuff damage. |
| The air tube is crimped or the cuff is tied too tight. | The air tube is obstructed, or the cuff is too tight. | Correct the air tube or cuff tightness and measure again. |
| The sensor is sensing great fluctuation in pressure | Movement or talking during measurement. | Remain still and quiet during measurement. |
| The pressure that the sensor sensing is over the limit | The cuff pressure exceeds the device's limit. | Contact local distributor for assistance. |
| The demarcation is incorrect or the device has not been demarcated | Incorrect calibration or device issue. | Contact local distributor for assistance. |
| HI (Pulse rate exceeds upper limit) | Pulse rate is too high (over 170 bpm). | Beyond the measurement range; normal reminder. Consult physician if concerned. |
| LO (Pulse rate is less than lower limit) | Pulse rate is too low (under 40 bpm). | Beyond the measurement range; normal reminder. Consult physician if concerned. |
| MR unsafe | Indicates a potential issue with the measurement or device. | Refer to specific error code or consult manual/support. |
Blood Pressure Category Guide (WHO Standards)
| Category | Systolic (mmHg) | Diastolic (mmHg) |
|---|---|---|
| Normal | < 120 | < 80 |
| Elevated | 120-129 | < 80 |
| High Blood Pressure (Hypertension) Stage 1 | 130-139 | 80-89 |
| High Blood Pressure (Hypertension) Stage 2 | ≥ 140 | ≥ 90 |
| Hypertension Crisis | > 180 | > 120 |
Note: This table provides general guidelines. Consult your physician for personalized advice.
Electromagnetic Compatibility (EMC) Information
This ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments.
Warnings:
- Do not use near active HF surgical equipment or in RF shielded rooms of ME systems for magnetic resonance imaging due to high EM disturbances.
- Avoid using adjacent to or stacked with other equipment to prevent improper operation. Observe normal operation if such use is necessary.
- Use only manufacturer-specified accessories to maintain compliance with emissions and immunity requirements.
- Keep portable RF communication equipment at least 30 cm (12 inches) away from the Blood Pressure Monitor to avoid performance degradation.
Table 1: Guidance and manufacturer's declaration - electromagnetic emissions
| Emissions test | Compliance | Guidance |
|---|---|---|
| RF emissions CISPR 11 | Group 1 | The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are unlikely to cause any interference with nearby electronic equipment. |
| RF emissions CISPR 11 | Class B | The device 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 IEC 61000-3-2 | Class A | The device complies with Class A for harmonic emissions. |
| Voltage fluctuations/ flicker emissions IEC 61000-3-3 | Applied | The device complies with voltage fluctuations and flicker emissions. |
Table 2: Guidance and manufacturer's declaration - electromagnetic Immunity
| Immunity Test | IEC 60601-1-2 Test level | Compliance level | Guidance |
|---|---|---|---|
| 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 | Humidity is at least 70% when using ±15 kV air discharge. Maintain integrity of the equipment. |
| Electrical fast transient/burst IEC 61000-4-4 | Power supply lines ±2 kV, input/output lines ±1 kV, 100 kHz repetition frequency | Power supply lines ±2 kV, input/output lines ±1 kV | Maintain integrity of the equipment. |
| Surge IEC 61000-4-5 | Line(s) to line(s) ±0.5 kV, Line(s) to earth ±1 kV | Line(s) to line(s) ±0.5 kV, Line(s) to earth ±1 kV | Humidity is at least 70%. Maintain integrity of the equipment. |
| Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 | 0% UT 0.5 cycle, 70% UT 25/30 cycles, 0% UT 300 cycles (Single phase: at 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°) | 0% UT 0.5 cycle, 70% UT 25/30 cycles, 0% UT 300 cycles | The mains power quality should be that of a typical domestic, business or hospital environment. If the user requires continued operation during power mains interruptions, it is recommended that the ME EQUIPMENT or ME SYSTEM is powered from a uninterruptible power supply. |
| Power frequency magnetic field IEC 61000-4-8 | 30 A/m 50Hz/60Hz | 30 A/m 50Hz/60Hz | The magnetic field is the value at the intended site of use. |
| Conducted RF IEC61000-4-6 | 150 KHz to 80 MHz: 3 Vrms (ISM and amateur radio bands: 6 Vrms) 80% AM at 1 kHz | 150 KHz to 80 MHz: 3 Vrms (ISM and amateur radio bands: 6 Vrms) | Portable and mobile RF communications equipment should be used no closer to any part of the ME EQUIPMENT or ME SYSTEM than the recommended distance calculated from the equation applicable to the frequency of the transmitter. |
| 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 | Portable and mobile RF communications equipment should be used no closer to any part of the ME EQUIPMENT or ME SYSTEM than the recommended distance calculated from the equation applicable to the frequency of the transmitter. |
| Proximity magnetic fields IEC 61000-4-39 | 30 kHz: 8 A/m, 134.2 kHz: 65 A/m, 13.56 MHz: 7.5 A/m | 30 kHz: 8 A/m, 134.2 kHz: 65 A/m, 13.56 MHz: 7.5 A/m | The magnetic field is the value at the intended site of use. |
Table 3: Guidance and manufacturer's declaration - electromagnetic Immunity for RF wireless communication equipment
| Test Frequency (MHz) | Band (MHz) | Service | Modulation | IMMUNITY TEST LEVEL (V/m) | Recommended Separation Distance (m) |
|---|---|---|---|---|---|
| 385 | 380-390 | TETRA 400 | Pulse modulation 18 Hz | 27 | 0.7 |
| 450 | 430-470 | GMRS 460, FRS 460 | FM ±5 kHz deviation 1 kHz sine | 28 | 0.7 |
| 710, 745, 780 | 704-787 | LTE Band 13, 17 | Pulse Modulation 217 Hz | 9 | 0.3 |
| 810, 870, 930 | 800-960 | GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 | Pulse Modulation 18 Hz | 28 | 0.7 |
| 1720, 1845, 1970 | 1700-1990 | GSM 1800; GSM 1900; CDMA 1900; DECT; LTE Band 1, 3, 4, 25; UMTS | Pulse Modulation 217 Hz | 28 | 0.7 |
| 2450 | 2400-2570 | Bluetooth, WLAN 802.11 b/g/n, RFID 2450, LTE Band 7 | Pulse Modulation 217 Hz | 28 | 0.7 |
| 5240, 5500, 5785 | 5100-5800 | WLAN 802.11 a/n | Pulse Modulation 217 Hz | 9 | 0.3 |
Note:
- The carrier shall be modulated using a 50% duty cycle square wave signal.
- For some services, only the uplink frequencies are included.
- If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.