GIMA M32918EN Smart Automatic Wrist Blood Pressure Monitor Installation Guide

GIMA M32918EN Smart Automatic Wrist Blood Pressure Monitor

IMPORTANT INFORMATION

Normal blood pressure fuctuation
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

INTENDED USE

Fully Automatic Electronic Blood Pressure Monitor 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 wrist. The cuff circumference is limited to 14cm-19.5cm (approx. 5 1/2”-7 11/16”).

PACKAGE CONTENTS

• 1 Blood Pressure Monitor With Attached Wrist Cuff
• 1 Operation Guide
• 1 Plastic Bag

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 60 measurements can be stored in the memory with date and time stamp. The Electronic Sphygmomanometers corresponds to the below standards: IEC 60601-1Edition 3.1 2012-08/EN 60601-1:2006/A1:2013 (Medical electrical equipment —

• Part 1: General requirements for basic safety and essential performance), IEC60601-1-2:2014/EN 60601-1-2:2015 (Medical electrical equipment
• Part 1-2: General requirements for basic safety and essential performance
• Collateral standard: Electromagnetic compatibility – Requirements and tests), IEC80601-2-30:2009+AMD1:2013/EN 80601-2-30:2010/A1:2015 (Medical electrical equipment –Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers) EN 1060-1: 1995 + A2: 2009 (Non-invasive sphygmomanometers
• Part 1: General requirements), EN 1060-3: 1997 + A2: 2009 (Non-invasive sphygmomanometers
• Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems);ISO81060-2 : 2013(Non-Invasive Sphygmomanometers –
• Part 2: Clinical Validation Of Automated Measurement Type).

SPECIFICATIONS

1. Product name: Blood Pressure Monitor
2. Model: KD-735
3. Classification: Internally powered, Type BF applied part, IP22, No AP or APG, Continuous operation.
4. Machine size: Approx. 85mm x 64.5mm x28mm (3 11/32” x 2 17/32” x 1 3/32”)
5. Cuff circumference:14cm – 19.5cm (5 1/2” – 7 11/16”)
6. Weight: Approx. 110g (3 7/8 oz.) (exclude batteries)
7. Measuring method: Oscillometric method, automatic ination and measurement
8. Memory volume: 2x 60 times with time and date stamp
9. Power source: batteries: 2 ×1.5V SIZE AAA
10. Measurement range:
    • Cuff pressure: 0-300 mmHg
    • Systolic: 60-260 mmHg
    • Diastolic: 40-199 mmHg
    • Pulse rate: 40-180 beats/minute
11. Accuracy:
    • Pressure: ±3mmHg
    • Pulse rate: Less than 60: ±3bpm
    • More than 60 (incl.): ±5%
12. Environmental temperature for operation: 5°C~40°C (41°F~104°F)
13. Environmental humidity for operation: 90%RH
14. Environmental temperature for storage and transport: -20°C~55°C (-4°F~131°F)
15. Environmental humidity for storage and transport: 90% RH
16. Environmental pressure: 80kPa-105kPa
17. Battery life: Approx 270 times
18. All components belonging to the pressure measuring system, including accessories: 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 wrist 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-ination (cuff pressure exceed 300 mmHg or maintained above 15 mmHg for longer than 3 minutes) of the bladder may cause ecchymoma of your wrist.

7. Consult your physician if you have any doubt about below cases:

8. The application of the cuff over a wound or inammation 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;

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 period0.14s, 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:

    • 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

24. 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.

25. Measurements are not possible in patients with a high frequency of arrhythmias.

26. 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.)

27. Motion, trembling, shivering may affect the measurement reading.

28. 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).

29. The device would not apply to the patients who use an articial heart and lung (there will be no pulse)

30. 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.

31. The patient is an intended operator.

32. Attention that changes or modification not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.

33. 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.

34. If you are allergic to plastic/rubber, please don’t use this device.

SETUP AND OPERATING PROCEDURES

1. Battery loading
2. Open battery cover at the back of the monitor.
3. Load two “AAA” size batteries. Please pay attention to polarity.
4. Close the battery cover.

When LCD shows battery symbol , replace all batteries with new ones. Rechargeable batteries are not suitable for this monitor. Remove the batteries if the monitor will not be used for a month or more to avoid relevant damage of battery leakage. 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. 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. Make sure the battery cover is intact and not damaged before installing the battery The monitor, the batteries and the cuff, must be disposed of according to local regulations at the end of their usage.

2. Clock and date adjustment

3. Once you install the battery or turn off the monitor, it will enter Clock Mode, and LCD will display time and date by turns. See picture 2&2-1.

4. While the monitor is in Clock Mode, pressing both the “START” and “MEM” button simultaneously, a beep is heard and the month will blink at rst. See picture 2-2. Press the button “START” repeatedly, the 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.

5. You can turn off the monitor by pressing “START” button when the minute is blinking, then the time and date is conrmed.

6. The monitor will turn off automatically after 1 minute of no operation, with the time and date unchanged.

7. Once you change the batteries, you should readjust the time and date.

8. Connecting the cuff to the monitor
   The cuff is attached to the monitor when it is packaged. Should the cuff become unattached, align the two plugs and four brackets of the cuff with the plug sockets and bracket sockets of the monitor and press the cuff to the monitor until the plugs and brackets are securely attached.

9. Applying the cuff

10. Place the cuff around a bare wrist 1-2cm above the wrist joint on the palm side of the wrist.

11. While seated, place the arm with the cuffed wrist in front of your body on a desk or table with the palm up. If the cuff is correctly placed, you can read the LCD display.

12. The cuff must be neither too tight nor too loose.

13. You can also take a measurement on your right wrist as the picture.
    Note :

14. Please refer to the cuff circumference range in “SPECIFICATIONS” to make sure that the appropriate cuff is used.

15. Measuring on same wrist each time.

16. Do not move your arm, body, or the monitor during measurement.

17. Stay quiet, calm for 5 minutes before blood pressure measurement.

18. Please keep the cuff clean. Clean the cuff by wet soft cloth and mild detergent if the cuff becomes dirty. Do not remove the cuff from the monitor. Clean the cuff after the usage of every 200 times is recommended.

19. Do not place the cuff around your wrist if the wrist has any inflammation, acute diseases, infections skin wounds.

20. Body posture during measurement
    Sitting Comfortably Measurement

21. Be seated with your feet flat on the floor, and don’t cross your legs.

22. Place palm upside in front of you on a flat surface such as a desk or table.

23. The middle of the cuff should be at the level of the right atrium of the heart.

24. Taking your blood pressure reading

25. 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 selftest. See picture 6. Please contact the service center if segment is missing.

26. Then the monitor starts to seek zero pressure. See picture 6-1.

27. The monitor inflates the cuff until sufficient pressure has built up for a measurement. 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 separately. Irregular heartbeat symbol (if any) will blink. See picture 6-2&6-3. The result will be automatically stored in the memory bank.

28. After measurement, the monitor will turn off automatically after 1 minute of no operation. Alternatively, you can press the “START” button to turn off the monitor manually.

29. 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.

30. Displaying stored results

31. After measurement, you can review the results in the memory bank by pressing the “MEM” button. Alternatively, you can press “MEM” button in Clock Mode to display the stored results. If it no result stored, LCD will show dashes as picture 7, while press the button “MEM” or “START”, machine will turn off. If there are results in the memory bank, the LCD will display the amount of the results in the memory bank. See picture 7-1.

32. And then, the most recent result will be displayed with date and time stamp. See picture7-2. Followed by, the blood pressure and pulse rate will be shown separately. Irregular heartbeat symbol (if any) will blink. See picture7-3&7-4. Press “MEM” button again to review the next result. See picture7-5. In this way, repeatedly pressing the MEM button displays the respective results measured previously.

33. 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.

34. Deleting measurements from the memory
    When any result is displaying, keeping on pressing button “MEM” for three seconds, all results in the current memory bank will be deleted after three “beep”. LCD will show picture 8, Press the button “MEM” or “START”, the monitor will turn off.

35. 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.

Classification of blood pressure for adults

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 SPECIFICATIONS. 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 present 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

MEASUREMENT”

sections of the instructions and re-test

Speaking, arm or body movement, angry, excited or nervous during testing| Re- test when calm and without speaking or moving during the test
Irregular heartbeat (arrhythmia)| It is inappropriate for people with serious arrhythmia

to use this Electronic Sphygmomanometer

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 infation| Apply the cuff correctly and try again
LCD shows “Er 4| Pneumatic system leak- age or cuff is too loose during infation
LCD shows “Er 5”| Cuff pressure above 300 mmHg| Measure again after ve minutes. If the monitor is still abnormal, please contact the local distributor or the factory
---|---|---
LCD shows “Er 6”| More than 3 minutes with cuff pressure above 15 mmHg
LCD shows “Er 7”| EEPROM accessing error
LCD shows “Er 8”| Device parameter checking error
LCD shows “Er A”| Pressure sensor parameter error
No response when you press button or load battery| Incorrect operation

or strong electromagnetic interference

| Take out batteries for ve 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.  If you do not use the monitor for a long time, please remove the batteries.
6. It is recommended the performance should be checked every 2 years or after repair. Please contact the service center.
7. Clean the monitor with a dry, soft cloth or a soft cloth squeezed well after moistened with water, diluted disinfectant alcohol, or diluted detergent.
8. 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 qualied technical personnel to repair those parts of equipment which are designated repairably can be supplied.
9. 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.
10. 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 con- tacts skin) of the cuff by a soft cloth squeezed after moistened with Ethyl alcohol (75-90%), then dry the cuff by airing.
11. 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.
12. 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
13. Not servicing/maintenance while the monitor is in use.

ELECTROMAGNETIC COMPATIBILITY INFORMATION

Table 1 Emission

Class B

| Home healthcare environment
Harmonic distortion| IEC 61000-3-2

Class A

| Home healthcare environment
Voltage fuctuations and ficker| IEC 61000-3-3

Compliance

| Home healthcare environment

Table 2  Enclosure Port

Home Healthcare Environment
Electrostatic Discharge| IEC 61000-4-2| ±8 kV contact

±2kV, ±4kV, ±8kV, ±15kV

air

Radiated RF EM eld| IEC 61000-4-3| 10V/m

80MHz-2.7GHz

80% AM at 1kHz

Proximity elds from RF wireless communications equipment| IEC 61000-4-3| Refer to table 3
Rated power frequency magnetic elds| 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

Disposal : The product must not be disposed of along with other domes- tic waste. The users must dispose of this equipment by bringing it to a specific recycling point for electric and electronic equipment. For further information on recycling points contact the local authorities, the local recycling center or the shop where the product was purchased. If the equipment is not disposed of correctly, nes or penalties may be applied  in accordance with the national legislation and regulations.

GIMA WARRANTY CONDITIONS

Congratulations for purchasing a GIMA product. This product meets high qualitative standards both as regards the material and the production. The warranty is valid for 12 months from the date of supply of GIMA. During the period of validity of the warranty, GIMA will repair and/or replace free of charge all the defected parts due to production reasons. Labor costs and personnel traveling expenses and packaging not included. All components subject to wear are not included in the warranty. The repair or replacement performed during the warranty period shall not extend the warranty. The warranty is void in the following cases: repairs performed by unauthorized personnel or with non-original spare parts, defects caused by negligence or incorrect use. GIMA cannot be held responsible for malfunctioning on electronic devices or software due to outside agents such as: voltage changes, electro-magnetic fields, radio interferences, etc. The warranty is void if the above regulations are not observed and if the serial code (if available) has been removed, cancelled or changed. The defected products must be returned only to the dealer the product was purchased from. Products sent to GIMA will be rejected.

ANDON HEALTH CO., LTD.
No. 3 JinPing Street, Ya An Road,
Nankai District,
Tianjin 300190, China
Made in China

Documents / Resources

| GIMA M32918EN Smart Automatic Wrist Blood Pressure Monitor [pdf] Installation Guide
M32918EN Smart Automatic Wrist Blood Pressure Monitor, M32918EN, Smart Automatic Wrist Blood Pressure Monitor, Wrist Blood Pressure Monitor, Blood Pressure Monitor, Pressure Monitor, Monitor
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