andon KD-5920BT Wireless Blood Pressure Monitor User Guide

andon KD-5920BT Wireless Blood Pressure Monitor

Product Information

Specifications

• Product Name: Wireless Blood Pressure Monitor
• Model: KD-5920BT
• Classification: Internally powered, Type BF applied part, IP21, No AP or APG, Continuous
• Cuff Size: 22cm-30cm (8 21/32 – 11 13/16), 30cm-42cm (11 13/16 – 16 17/32)
• Weight: Approx. 233g (8 7/32oz.) (excluding batteries)
• Cuff Pressure: 0-300mmHg
• Systolic Pressure: 60-260mmHg
• Diastolic Pressure: 40-199mmHg
• Pulse Rate: 40-180 beats/minute
• Accuracy:
  • Environmental Pressure: 80kPa-105kPa
  • Battery Life: Approx. 100 times
  • Wireless Communication: Bluetooth V5.2 Class 2
  • Frequency Band: 2.402-2.480GHz

Product Description
The Wireless Blood Pressure Monitor (Model KD-5920BT) is a fully automatic electronic sphygmomanometer designed for use by medical professionals or at home. It is a non-invasive blood pressure measurement system that measures the diastolic and systolic blood pressures and pulse rate of an adult individual using a non-invasive technique. The monitor comes with an inflatable cuff that is wrapped around the upper arm. The cuff circumference is limited to 17cm- 42cm (approx. 6 11/16-16 17/32). The package includes the blood pressure monitor, an operation guide, an arm cuff, and a soft storage case.

Product Usage Instructions

Important Information
It is important to note that blood pressure fluctuates throughout the day and is influenced by various factors such as physical activity, stress, eating, drinking, smoking, and body posture. Therefore, it is recommended to measure your blood pressure at approximately the same time each day to obtain consistent results. It is also advised to relax for a minimum of 1 to 1.5 minutes between measurements to allow the blood circulation in your arm to recover. It is rare to obtain identical blood pressure readings each time.

Contents and Display Indicators
Note : The pictures in the manual are for reference only.

Intended Use
The Wireless Blood Pressure Monitor is intended for use by medical professionals or at home. It is a non-invasive blood pressure measurement system that measures the diastolic and
systolic blood pressures and pulse rate of an adult individual using a non- invasive technique. The monitor features a fully automatic operation and comes with an arm cuff that should be
wrapped around the upper arm. The cuff circumference is limited to 17cm-42cm (approx. 6 11/16-16 17/32).

Contraindication
It is not suitable for individuals with serious arrhythmia to use this Electronic Sphygmomanometer.

Package Contents

• 1 Blood Pressure Monitor
• 1 Operation Guide
• 1 Arm Cuff
• 1 Soft Storage Case

FAQ

• Q: Can I use the Wireless Blood Pressure Monitor if I have a serious arrhythmia?
  A: No, it is not appropriate for individuals with serious arrhythmia to use this Electronic Sphygmomanometer.

• Q: Can I use the monitor frequently?
  A: It is recommended to measure your blood pressure at approximately the same time each day. Too frequent measurements may cause injury due to blood flow interference. It is advised to relax for a minimum of 1 to 1.5 minutes between measurements to allow the blood circulation in your arm to recover.

Operation Guide (V1.0)

• Product/project name: Blood Pressure Monitor
• Model name： KD-5920BT
• Drafted by: _Date___
• Reviewed by: ___Date_
• Approved by: ___Date_

MODEL KD-5920BT
Wireless Blood Pressure Monitor (ELECTRONIC SPHYGMOMANOMETER)

OPERATION GUIDE
IMPORTANT INFORMATION

NORMAL BLOOD PRESSURE FLUCTUATION

• All physical activity, excitement, stress, eating, drinking, smoking, body posture and many other activities or factors (including taking a blood pressure measurement) will influence blood pressure value. Because of this, it is mostly unusual to obtain identical multiple blood pressure readings.
• Blood pressure fluctuates continually —– day and night. The highest value usually appears in the daytime and lowest one usually at midnight. Typically, the value begins to increase at around 3:00AM, and reaches to highest level in the daytime while most people are awake and active.
• Considering the above information, it is recommended that you measure your blood pressure at approximately the same time each day.
• Too frequent measurements may cause injury due to blood flow interference, please always relax a minimum of 1 to 1.5 minutes between measurements to allow the blood circulation in your arm to recover. It is rare that you obtain identical blood pressure readings each time.

CONTENTS AND DISPLAY INDICATORS

Note: The pictures in the manual are for reference only.

INTENDED USE
Fully Automatic Electronic Sphygmomanometer is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 17cm-42cm(approx. 6 11/16″-16 17/32″).

PACKAGE CONTENTS

• 1 Blood Pressure Monitor
• 1 Operation Guide
• 1 Arm Cuff
• 1 Soft Storage Case

CONTRAINDICATION
It is inappropriate for people with serious arrhythmia to use this Electronic Sphygmomanometer.

PRODUCT DESCRIPTION

Based on Oscillometric methodology and silicon integrated pressure sensor, blood pressure and pulse rate can be measured automatically and non- invasively. The LCD display will show blood pressure and pulse rate. The most recent 4X30 measurements can be stored in the memory with date and time stamp. The Electronic Sphygmomanometers corresponds to the below standards: IEC 60601-1: 2005+AMD1: 2012+AMD2:2020/EN 60601-1:2006+AC:2010+A1:2013+A12:2014+AC:2016+A2:2021(Medical electrical equipment — Part 1: General requirements for basic safety and essential performance), IEC 60601-1-2:2014/AMD1:2020/EN 60601-1-2:2015+A1:2021(Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests), IEC80601-2-30:2018/EN IEC 80601-2-30:2019(Medical electrical equipment –Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers);EN 1060-3: 1997 + A2: 2009 (Non-invasive sphygmomanometers -Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems);ISO81060-2 ：2018(Non-Invasive Sphygmomanometers – Part 2: Clinical investigation of intermittent automated measurement type).

SPECIFICATIONS

1. Product name: Wireless Blood Pressure Monitor
2. Model: KD-5920BT
3. Classification: Internally powered, Type BF applied part,IP21,No AP or APG, Continuous operation
4. Machine size: Approx.150mm×95mm×41mm( 5 29/32″x 3 3/4″x 1 5/8″)
5. Cuff circumference:22cm-42cm(8 21/32 ″- 16 17/32 ″), 17cm-22cm （6 11/16 ″~8 21/32 ″） (Optional), 22cm-30cm(8 21/32 ″ – 11 13/16 ″ )(Optional), 30cm-42cm(11 13/16″-16 17/32″)(Optional)
6. Weight: Approx.233g (8 7/32oz.) (exclude batteries)
7. Measuring method: Oscillometric method, automatic inflation and measurement
8. Memory volume: 2×120 times with time and date stamp
9. Power source: batteries: 4 ×1.5V SIZE AAA
10. Measurement range:
11. Cuff pressure: 0-300mmHg
12. Systolic: 60-260mmHg
13. Diastolic: 40-199mmHg
14. Pulse rate: 40-180 beats/minute
15. Accuracy:
16. Pressure: ±3mmHg
17. Pulse rate: Less than 60: ±3bpm
18. More than 60 (incl.) : ±5%
19. precision of the displayed values：1mmHg
20. Environmental temperature for operation: 5℃～40℃(41℉～104℉)
21. Environmental humidity for operation: ≤85%RH
22. Environmental temperature for storage and transport: -20℃～55℃(-4℉～131℉)
23. Environmental humidity for storage and transport: ≤90%RH
24. Environmental pressure: 80kPa-105kPa
25. Battery life: Approx 100 times.
26. Wireless communication:
27. Bluetooth V5.2 Class 2
28. Frequency Band: 2.402-2.480GHz
29. All components belonging to the pressure measuring system, including:Pump,Valve, LCD, Cuff, Sensor

Note: These specifications are subject to change without notice.

NOTICE

1. Read all of the information in the operation guide and any other literature in the box before operating the unit.
2. Stay still, calm and rest for 5 minutes before blood pressure measurement.
3. The cuff should be placed at the same level as your heart.
4. During measurement, neither speak nor move your body and arm.
5. Measuring on same arm for each measurement.
6. Please always relax at least 1 or 1.5 minutes between measurements to allow the blood circulation in your arm to recover. Prolonged over-inflation (cuff pressure exceed 300 mmHg or maintained above15 mmHg for longer than 3 minutes) of the bladder may cause ecchymoma of your arm.
7. Consult your physician if you have any doubt about below cases:
8. The application of the cuff over a wound or inflammation diseases;
9. The application of the cuff on any limb where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present;
10. The application of the cuff on the arm on the side of a mastectomy or lymph node clearance;
11. Simultaneously used with other monitoring medical equipments on the same limb;
12. Need to check the blood circulation of the user.
13. This Electronic Sphygmomanometers is designed for adults and should never be used on infants or young children. Consult your physician or other health care professionals before use on older children.
14. Do not use this unit in a moving vehicle, This may result in erroneous measurement.
15. Blood pressure measurements determined by this monitor are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultation method, within the limits prescribed by the American National Standard Institute, Electronic or automated sphygmomanometers.
16. Information regarding potential electromagnetic or other interference between the blood pressure monitor and other devices together with advice regarding avoidance of such interference please see part ELECTROMAGNETIC COMPATIBILITY INFORMATION. It is suggested that the blood pressure monitor be kept at least 30 cm away from other wireless devices, such as WLAN unit, microwave oven, etc. It can’t be used near active HF SURGICAL EQUIPMENT and the RF shielded room of an ME SYSTEM for magneticresonance imaging, where the intensity of EM DISTURBANCES is high.
17. If Irregular Heartbeat (IHB) brought by common arrhythmias is detected in the procedure of blood pressure measurement, a signal of will be displayed. Under this condition, the Electronic Sphygmomanometers can keep function, but the results may not be accurate, it’s suggested that you consult with your physician for accurate assessment. There are 2 conditions under which the signal of IHB will be displayed:
18. The coefficient of variation (CV) of pulse period >25%.
19. The difference of adjacent pulse period≥0.14s, and the number of such pulse takes more than 53 percentage of the total number of pulse.
20. Please do not use the cuff other than supplied by the manufacturer, otherwise it may bring biocompatible hazard and might result in measurement error.
21. The monitor might not meet its performance specifications or cause safety hazard if stored or used outside the specified temperature and humidity ranges in specifications.
22. Please do not share the cuff with other infective person to avoid cross-infection.
23. 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:
24. Reorient or relocate the receiving antenna.
25. Increase the separation between the equipment and receiver.
26. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
27. Consult the dealer or an experienced radio/TV technician for help.
28. The device is not intended for use on neonates, children or pregnant women. (Clinical testing has not been conducted on neonates, children or pregnant women.)
29. Motion, trembling, shivering during measurement may affect the measurement reading.
30. The device would not apply to the patients with poor peripheral circulation, noticeably low blood pressure, or low body temperature (there will be low blood flow to the measurement position).
31. The device would not apply to the patients who use an artificial heart and lung (there will be no pulse).
32. Consult your physician before using the device for any of the following conditions: common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, arterial sclerosis, poor perfusion, diabetes, pre-eclampsia, renal diseases.
33. The patient is an intended operator.
34. Attention that changes or modification not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
35. Swallowing batteries and/or battery fluid can be extremely dangerous. Keep the batteries and the unit out of the reach of children and disabled persons.
36. If you are allergic to plastic/rubber, please don’t use this device.
37. The blood pressure monitor is not intended to exposed to the Electromagnetic Interference (EMI)environment, please do not use the blood pressure monitor within the environment of the following device: Magnetic Resonance Imaging (MRI), computerized axial tomography (CT), diathermy, Radio Frequency Identification (RFID), and electromagnetic security systems such as metal detectors.
38. Keep the cuff tube away from children to prevent the risk of strangulation or asphyxiation.

SETUP AND OPERATING PROCEDURES

BATTERY LOADING

1. Open battery cover at the back of the monitor.
2.  Load four “AAA” size batteries. Please pay attention to polarity.
3. Close the battery cover.
4. When LCD shows battery symbol , replace all batteries with new ones. Rechargeable batteries are not suitable for this monitor.
5. Remove the batteries if the monitor will not be used for a month or more to avoid relevant damage of battery leakage.
6. Avoid the battery fluid to get in your eyes. If it should get in your eyes, immediately rinse with plenty of clean water and contact a physician.
7. The negative terminal of the battery needs to be compressed into the battery compartment properly after horizontal compression of the negative electrode. The battery is in contact with the spring.
8. Make sure the battery cover is intact and not damaged before installing the battery.
9. The monitor, the batteries and the cuff, must be disposed of according to local regulations at the end of their usage.

CLOCK AND DATE ADJUSTMENT AND BLUETOOTH SET

1. Once you insert the battery, the Blood Pressure Monitor will enter Clock and Date Adjustment Mode.
2. If the time of the device is already set and need to be changed, adjustment can be reached by pressing both the “START” and “MEM” button for 2 seconds in Standby Mode.
3. In Clock and Date Adjustment Mode , the time format will blink at first， Press the button “MEM” can change time format. Press the button “START” repeatedly, the year, month, day, hour and minute will blink in turn. While the number is blinking, press the button “MEM” to increase the number. Keep on pressing the button “MEM”, the number will increase fast.
4. The monitor will turn off automatically after 1 minute of no operation with the time and date unchanged.
5. You can set the bluetooth by pressing “START”button when the minute is blinking, then the time and date is confirmed. press the button “MEM”to change the state of bluetooth. If bluetooth is on, bluetooth symbol twinkles. See picture 2- 7. If bluetooth is off, bluetooth symbol don’t show.
6. Once you change the batteries, you should readjust the time and date.

CONNECTING THE CUFF TO THE MONITOR

• Insert the cuff tubing connector into the socket in the left side of the monitor. Make certain that the connector is completely inserted to avoid air leakage during blood pressure measurements.
• Avoid compression or restriction of the connection tubing during measurement， which may cause inflation error, or harmful injury due to continuous cuff pressure.

APPLYING THE CUFF

1. Pulling the cuff end through the medal loop (the cuff is packaged like this already), turn it outward (away from your body) and tighten it and close the Velcro fastener. See Picture 4-1.

2. Place the cuff around a bare arm 1-2cm above the elbow joint.

3. If you place the cuff around left arm, position the air tube in the middle of your arm in line with your middle finger. See Picture 4-2.
   If you place the cuff around right arm, apply the cuff so that the air tube is at the side of your elbow.See Picture 4-3.

4. While seated, place palm upside in front of you on a flat surface such as a desk or table. Position the air tube in the middle of your arm in line with your middle finger.

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

Note:

1. Please refer to the cuff circumference range in “SPECIFICATIONS” to make sure that the appropriate cuff is used.
2. Measuring on same arm each time.
3. Do not move your arm, body, or the monitor and do not move the rubber tube during measurement.
4. Stay quiet, calm for 5 minutes before blood pressure measurement.
5. Please keep the cuff clean. If the cuff becomes dirty, remove it from the monitor and clear it by hand in a mild detergent, then rinse it thoroughly in cold water. Never dry the cuff in clothes dryer or iron it. Clean the cuff after the usage of every 200 times is recommended.
6. Do not place the cuff around your arm if the arm has any inflammation, acute diseases, infections skin wounds.

BODY POSTURE DURING MEASUREMENT

Sitting Comfortably Measurement

1. Be seated with your feet flat on the floor, and don’t cross your legs.
2. Place palm upside in front of you on a flat surface such as a desk or table.
3. The middle of the cuff should be at the level of the right atrium of the heart.

Lying Down Measurement

1. Lie on your back.
2. Place your arm straight along your side with your palm upside.
3. The cuff should be placed at the same level as your heart.

TAKING YOUR BLOOD PRESSURE READING

1. After applying the cuff and your body is in a comfortable position, press the “START” button. A beep is heard and all display characters are shown for self-test. See Picture 6-1. Please contact the service center if segment is missing.
2. Then the current memory bank ( ) is shown. See Picture 6-2. Press “MEM” button to change over to other bank. Confirm your selection by pressing “START” button. The current bank can also be confirmed automatically after 5 seconds with no operation.
3. If the monitor has stored results, the LCD will momentarily display the most recent one. If no result has been stored, zero will appear on LCD. See Picture 6-3.
4. Then the monitor starts to seek zero pressure. See Picture 6-4.
5. Then the monitor inflates the cuff until sufficient pressure has built up for a measurement. The cuff wrap symbol( ) flashes at the early stage of inflation, and if the monitor detects that the cuff is tight enough during inflation, the cuff wrap “ok” symbol( ) is displayed on the LCD. Otherwise, the cuff wrap symbol( ) is displayed on the LCD. Then the monitor slowly releases air from the cuff and carries out the measurement. Finally the blood pressure and pulse rate will be calculated and displayed on the LCD screen. The blood pressure classification indicator and Irregular heartbeat symbol (if any) will blink on the screen. If the monitor detects body movement during measurement, the LCD displays the Body Movement symbol. The result will be automatically stored in the monitor. See Picture 6-5.
6. After measurement If bluetooth is on, you can press the “START” button and upload current measurement result by Bluetooth. See Picture 6-6.Then the monitor will turn off automatically after upload.
7. During measurement, you can press the “START” button to turn off the monitor manually.

Note: Please consult a health care professional for interpretation of pressure measurements.
Note: Cuff wrap indicator applies to 22cm-42cm, 22cm-30cm, 30cm-42cm cuffs, the cuff wrap symbol( and ) has no reference meaning when using other cuffs

DISPLAYING STORED RESULTS

1. In Standby Mode, press “MEM” button to display the stored results. The current memory bank will blink and the amount of results in this bank will be displayed. Press “START” button to change over to other bank. Confirm your selection by pressing “MEM” button. The current bank can also be confirmed automatically after 5 seconds with no operation. See Picture 7-1.

2. After selecting the memory bank, the LCD will display the average values in this bank. See Picture 7-2. If bluetooth is on, the Bluetooth symbol flashing and the monitor will upload all memory by Bluetooth. If no result stored, LCD will show zeros. See Picture
   7- 6.

3. Press “MEM” button, the LCD will display the average values of last 3 results in this bank. See Picture 7-3. If no result stored, LCD will show zeros.

4. Press “MEM” button, LCD will display the average value of all the results which is measured from 5 o’clock to 9 o’clock in last 7 days in the current user memory zone. See Picture 7-4. If no result stored from 5 o’clock to 9 o’clock in last 7 days, LCD will display “0” for blood pressure and pulse rate.

5. Press “MEM” button again, LCD will display the average value of all the results which is measured from 18 o’clock to 20 o’clock in last 7 days in the current user memory zone. If no result stored from 18 o’clock to 20 o’clock in last 7 days, LCD will display “0” for blood pressure and pulse rate. See Picture 7-5.

6. Then press the “MEM” button, the most recent result will be displayed. See Picture
   7- 7. Followed by, the blood pressure and pulse rate will be shown separately. Irregular heartbeat symbol (if any) will blink. Press “MEM” button again to review the next result. In this way, repeatedly pressing the “MEM” button displays the respective results measured previously.If no result stored, LCD will show zeros. See Picture 7-6.

7. When displaying the stored results, the monitor will turn off automatically after 1 minute of no operation. You can also press the button “START” to turn off the monitor manually.

DELETING MEASUREMENTS FROM THE MEMORY
When any result is displaying, keeping on pressing button “MEM” for three seconds, all results will be deleted. Press the button “MEM” or “START”, the monitor will turn off.

ASSESSING HIGH BLOOD PRESSURE FOR ADULTS

The following guidelines for assessing high blood pressure (without regard to age or gender) have been established by the World Health Organization (WHO). Please note that other factors (e.g. diabetes, obesity, smoking, etc.) need to be taken into consideration. Consult with your physician for accurate assessment, and never change your treatment by yourself. Note: It is not intended to provide a basis of any type of rush toward emergency conditions/diagnosis based on the color scheme and that the color scheme is meant only to discriminate between the different levels of blood pressure.

TECHNICAL ALARM DESCRIPTION

• The monitor will show ‘HI’ or ‘Lo’ as technical alarm on LCD with no delay if the determined blood pressure (systolic or diastolic) is outside the rated range specified in part SPECIFICACIONS. In this case, you should consult a physician or check if your operation violated the instructions.
• The technical alarm condition (outside the rated range) is preset in the factory and cannot be adjusted or inactivated. This alarm condition is assigned as low priority according to IEC 60601-1-8.
• The technical alarm is non-latching and need no reset. The signal displayed on LCD will disappear automatically after about 8 seconds.

TROUBLESHOOTING (1)

the cuff correctly and try again
| | Review the “BODY
LCD Display shows abnormal result| Body posture was not correct during testing| POSTURE DURING MEASUREMENT” sections of the instructions and re-test.
Speaking, arm or body| Re-test when calm and
| movement, angry, excited or| without speaking or moving
| nervous during testing| during the test
| | It is inappropriate for people
| Irregular heartbeat (arrhythmia)| with serious arrhythmia to use this Electronic
| | Sphygmomanometer.

TROUBLESHOOTING (2

LCD Display shows battery

symbol

| Low Battery| Change the batteries
LCD shows “Er 0”| Pressure system is unstable before measurement| Don’t move and try again.
LCD shows “Er 1”| Fail to detect systolic pressure
LCD shows “Er 2”| Fail to detect diastolic pressure
LCD shows “Er 3”| Pneumatic system blocked or cuff is too tight during inflation| Connect the cuff correctly and try again. If the monitor is still abnormal, please contact the local distributor or the factory
LCD shows “Er 4”| Pneumatic system leakage or cuff is too loose during inflation
LCD shows “Er 5”| Cuff pressure above 300mmHg| Measure again after five minutes. If the monitor is still abnormal, please contact the local distributor or the factory.
LCD shows “Er 6”| More than 160 seconds with cuff pressure above 15 mmHg
LCD shows| Inner memory error
“Er 7”| |
---|---|---
LCD shows “Er 8”| Device parameter checking error
LCD shows “Er A”| Pressure sensor parameter error
LCD shows “Er b”| Bluetooth connection unsuccessful, monitor is abnormal, or strong electromagnetic interference is present| Reset iOS/Android device. Reset monitor. Make sure the monitor and iOS/Android device are away from other electrical equipment.
No response when you press button or load battery.| Incorrect operation or strong electromagnetic interference.| Take out batteries for five minutes, and then reinstall all batteries.

MAINTENANCE

1. Do not drop this monitor or subject it to strong impact.
2. Avoid high temperature and solarization. Do not immerse the monitor in water as this will result in damage to the monitor.
3. If this monitor is stored near freezing, allow it to acclimate to room temperature before use.
4. Do not attempt to disassemble this monitor.
5. It is recommended the performance should be checked every 2 years or after repair. Please contact the service center.
6. Clean the monitor with a dry, soft cloth or a soft cloth squeezed well after moistened with water, diluted disinfectant alcohol, or diluted detergent.
7. No component can be maintained by user in the monitor. The circuit diagrams, component part lists, descriptions, calibration instructions, or other information which will assist the user’s appropriately qualified technical personnel to repair those parts of equipment which are designated repairable can be supplied.
8. The monitor can maintain the safety and performance characteristics for a minimum of 10,000 measurements or three years, and the cuff integrity is maintained after 1,000 open–close cycles of the closure..
9. It is recommended the cuff should be disinfected 2 times every week if needed (For example, in hospital or in Clinique). Wipe the inner side (the side contacts skin) of the cuff by a soft cloth squeezed after moistened with Ethyl alcohol (75-90%), then dry the cuff by airing.
10. The monitor requires 6 hours to warm from the minimum storage temperature between uses until the monitor is ready for its INTENDED USE when the ambient temperature is 20 °C.
11. The monitor requires 6 hours to cool from the maximum storage temperature between uses until the monitor is ready for its INTENDED USE when the ambient temperature is 20 °C.
12. No servicing/maintenance while the monitor is in use.

EXPLANATION OF SYMBOLS ON UNIT

• Symbol for” THE OPERATION GUIDE MUST BE READ”(The sign background colour: blue.The sign graphical symbol: white)

• Symbol for “WARNING”

• Symbol for “TYPE BF APPLIED PARTS” (The cuff is type BF applied part)

• Symbol for “ENVIRONMENT PROTECTION – Waste electrical products should not be disposed of with household waste. Please recycle where facilities exist. Check with your local Authority or retailer for recycling advice”.

• Symbol for “MANUFACTURER”

• Symbol for “COMPILES WITH MDD93/42/EEC REQUIREMENTS”

• Symbol for “DATE OF MANUFACTURE”

• Symbol for “EUROPEAN REPRESENTATION”

• Symbol for “SERIAL NUMBER”
  IP 21 The first characteristic numeral symbol for “Degrees of protection against access to hazardous parts and against solid foreign objects “.The second characteristic numeral symbol for “Degrees of protection against ingress of water”

• MR Unsafe

• Recyclable identification

WARRANTY INFORMATION

only charge the cost of components and transport.

ANDON HEALTH CO., LTD.

• No. 3 JinPing Street, YaAn Road, Nankai District, Tianjin 300190, China.
• Tel: 86-22-87611660

iHealthLabs Europe SAS
36 rue de Ponthieu, 75008, Paris, France

IMPORTANT INFORMATION REQUIRED BY THE R &TTE

• The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, In c and any use of such marks by ANDON HEALTH CO., LTD. is under license.
• Other trademarks and trade names are those of their respective owners.
• Hereby, ANDON HEALTH CO., LTD. declares that the radio equipment type KD-5920BT is in compliance with Directive 2014/53/EU.
• The full text of the EU declaration of conformity is available at the following internet address: https://cdn.ihealthlabs.com/policy/EU_DECLARATION_OF_CONFORMITY.pdf

ELECTROMAGNETIC COMPATIBILITY INFORMATION

This product is applicable to the equipment and system requirements for the purpose of receiving radio frequency energy for the purpose of the work, Bluetooth receive bandwidth 2M. This product can also be used to include RF transmitter equipment and system requirements and emission frequency of 2.4GHz ISM band, Bluetooth modulation
types: GFSK , effective radiated power: < 20dBm

• The essential performance: 1. Limits of the error of the cuff pressure indication;2.Reproducibility of the blood pressure DETERMINATION; 3. Alarm.When electromagnetic interference affects the above performance, please stop using the device.
• 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 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.”
• Equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of theKD-5920BT, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.”

Table 1 – Emission

Table 2 – Enclosure Port

Home Healthcare Environment
Electrostatic Discharge| IEC 61000-4-2| ±8 kV contact ±2kV, ±4kV, ±8kV, ±15kV air
Radiated RF EM field| IEC 61000-4-3| 10V/m 80MHz-2.7GHz 80% AM at 1kHz
Proximity fields from RF wireless communications equipment| IEC 61000-4-3| Refer to table 3
---|---|---
Rated power frequency

magnetic fields

| IEC 61000-4-8| 30A/m 50Hz or 60Hz

Table 3 – Proximity fields from RF wireless communications equipment

Professional healthcare facility environment
385| 380-390| Pulse modulation 18Hz, 27V/m
450| 430-470| FM, ±5kHz deviation, 1kHz sine, 28V/m
710| 704-787| Pulse modulation 217Hz, 9V/m
745
780
810| 800-960| Pulse modulation 18Hz, 28V/m
870
930
1720| 1700-1990| Pulse modulation 217Hz, 28V/m
1845
1970
2450| 2400-2570| Pulse modulation 217Hz, 28V/m
5240| 5100-5800| Pulse modulation 217Hz, 9V/m
5500
5785

Date of issue: Nov. 13, 2023

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