PCBMG 3019 - Heart rate monitor ProfiCare - Free user manual and instructions

USER MANUAL PCBMG 3019 ProfiCare

5 kHz, sinus 1 kHz, 28 V/m

5 kHz, sinusoidale 1 kHz, 28 V/m

Maintenance..............................................................................................................116 Explanation of Symbols on Appliance ......................................................................116 Electromagnetic Compatibility Information ............................................................... 118 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 inuence blood pressure value. Because of this, it is mostly unusual to obtain identi- cal multiple blood pressure readings.PC-BMG3019_IM_new4 09.07.19

Blood pressure uctuates continually --- day and night. The highest value usually appears in the daytime and the lowest one usually at midnight. Typically, the value begins to increase at around 3:00 AM, 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 ow 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 1 LCD display 2 Button MEM 3 Button START 4 Cuff 5 Cuff tubing connector socket 6 Low battery indicator 7 Systolic pressure 8 Diastolic pressure / pulse rate display (alternating) 9 Date / Time display (alternating) 10 Memory indicator 11 Irregular heartbeat symbol 12 Blood pressure level classication Indicator 13 “Ready to inate” indicator Intended Use The fully automatic electronic sphygmomanometer is for use by medical profession- als or at home. It is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individ- ual by using a non-invasive technique in which an inatable cuff is wrapped around the upper arm. The cuff circumference is limited to 30 cm - 42 cm.PC-BMG3019_IM_new4 09.07.19

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 2 × 60 measure- ments can be stored in the memory with date and time stamp. The monitor can also show the average reading of the last three measurements. The electronic sphygmomanometers corresponds to the below standards: IEC 60601-1 Edition 3.1 2012-08 / EN 60601-1: 2006 / A1: 2013 (Medical electrical equipment - Part 1: General requirements for basic safety and essential perfor- mance), IEC60601-1-2: 2014 / EN 60601-1-2: 2015 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collat- eral standard: Electromagnetic compatibility - Requirements and tests), IEC 80601-2-30: 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 sphygmomanom- eters - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems), ISO 81060-2: 2013 (Non-invasive sphygmomanometers -

Part 2: Clinical validation of automated measurement type).

1. Product name: Blood pressure monitor

2. Model: PC-BMG 3019 (KD-558BR)

3. Classication: Internally powered, Type BF applied part, IP20 (Level of protection

against touching and foreign objects), No AP or APG, Continuous operation

6. Weight: Approx. 300 g (batteries and cuff excluded)

7. Measuring method: Oscillometric method, automatic ination and measurement

Pressure: ± 3 mmHg Pulse rate: ± 5 %

12. Environmental temperature for operation: +10 °C to +40 °C (50 °F to 104 °F)

13. Environmental humidity for operation: ≤ 85 % RH

14. Environmental temperature for storage and transport: -20 °C to +50 °C

15. Environmental humidity for storage and transport: ≤ 85 % RH

16. Environmental pressure: 80 kPa to 105 kPa

17. Battery life: Approx. 270 measurements

18. Scope of Delivery: Pump, valve, LCD, cuff, sensor

19. Package contents: 1 blood pressure monitor with attached wrist cuff;

1 operation guide; 1 plastic bag Notices

1. Read all of the information in the operation guide and any other literature in

the box before operating the appliance.

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 each time.

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 arm.

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

1) The application of the cuff over a wound or inammation diseases;

2) The application of the cuff on any limb where intravascular access or therapy,

or an arterio-venous (A-V) shunt, is present;

3) The application of the cuff on the arm on the side of a mastectomy;PC-BMG3019_IM_new4 09.07.19

4) Simultaneously used with other monitoring medical equipments on the same

This electronic sphygmomanometer is designed for adults and should never be used for infants or young children. Consult your physician or other health care professionals before use on older children. Pregnant women including pre-eclampsia patients should always ask their physician whether they can use this blood pressure monitor.

9. Do not use this appliance in a moving vehicle, This may result in erroneous

10. 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.

11. Use of the appliance adjacent to or stacked with other equipment should be

avoided because it could result in improper operation. Information regarding potential electromagnetic or other interference between the blood pressure monitor and other appliances together with advice regarding avoidance of such interference please see part “Electromagnetic Compatibility Information”. It is suggested that the blood pressure monitor be kept 10 meters away from other wireless appliances, such as WLAN unit, microwave oven, etc.

12. If an irregular heartbeat (IHB) from common arrhythmias is detected in the pro-

cedure of blood pressure measurement, this sign 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: (IHB = IRREGULAR HEARTBEAT)

1) The coefcient of variation (CV) of the pulses is > 25 %.

2) The deviation of the following pulse period is ≥ 0.14 s, and the number of such

pulses amounts to more than 53 % of the total number of measured pulses.

13. Please do not use the cuff other than supplied by the manufacturer, otherwise it

may bring biocompatible hazard and might result in measurement error.

The monitor might not meet its performance specications or cause a safety hazard if stored or used outside the temperature and humidity ranges specied in the specications.PC-BMG3019_IM_new4 09.07.19

15. Please do not share the cuff with other contagious persons to avoid cross-in-

16. This equipment has been tested and found to comply with the limits for a Class B

digital appliance, 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 guar- antee 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 distance between the equipment and the receiver. - Connect the appliance to 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.

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

18. The appliance is not intended for use on neonates, children or pregnant women.

(Clinical testing has not been conducted on neonates, children or pregnant women.)

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

20. The appliance would not apply to the patients with poor peripheral circulation,

noticeably low blood pressure, or low body temperature (there will be low blood ow to the measurement position).

21. The appliance would not apply to the patients who use an articial heart and lung

(there will be no pulse).

22. Consult your physician before using the appliance for any of the following

conditions: common arrhythmias such as atrial or ventricular premature beats or atrial brillation, arterial sclerosis, poor perfusion, diabetes, pre-eclampsia, renal diseases.

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

24. The patient can be an intended operator.

25. Swallowing batteries and / or battery uid can be extremely dangerous. Keep

the batteries and the appliance out of the reach of children and disabled persons.PC-BMG3019_IM_new4 09.07.19

Setup and Operating Procedures

a. Open battery cover at the back of the monitor. b. Load four batteries of the type “AA”. Please pay attention to polarity. c. Close the battery cover. When the LCD shows the 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. Do not let battery uid get into your eyes. If it should get in your eyes, immedi- ately rinse with plenty of clean water and contact a physician. 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

a. 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 Fig. 2-1 & 2-2. Fig. 2-1 Fig. 2-2 Fig. 2-3 b. While the monitor is in Clock Mode, pressing the “START” button and the “MEM” button simultaneously; a beep is heard and the month will ash rst. See Fig. 2-3. Press the button “START” repeatedly; the day, the hour and the minute will ash in turn. While a number is ashing, press the button “MEM” to increase the number. Keep on pressing the button “MEM”, the number will increase fast. c. You can turn off the monitor by pressing the “START” button when the min- utes are ashing, then the time and the date are conrmed. d. The monitor will turn off automatically after 1 minute of no operation; with the time and date unchanged. e. After replacing the batteries, you should set the time and the date again.PC-BMG3019_IM_new4 09.07.19

3. 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 measure- ments. Avoid compression or restriction of the connection tubing during measure- ment, as this may cause an ination error or harmful injury due to continuous cuff pressure.

4. Applying the Cuff

a. If required, pull the cuff end through the medal loop (the cuff is packaged like this already). b. Place the cuff around a bare arm 1 to 2 cm above the elbow joint. c. While sitting, place your hand with the palm facing up onto a at surface like a table or similar. Position the air tube in the middle of your arm in line with your middle nger. d. Tighten the cuff and close the Velcro fastener. The cuff should t comfortably, yet snugly around your arm. You should be able to insert one nger between your arm and the cuff. Note:

1. Please refer to the cuff circumference range in “Specications” 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

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.

5. Body Posture during Measurement

Sitting Comfortably Measurement a. Be seated with your feet at on the oor, and don’t cross your legs. Support the back with the backrest of the chair.PC-BMG3019_IM_new4 09.07.19

b. Place palm upside in front of you on a at surface such as table. c. The middle of the cuff should be at the level of the right atrium of the heart. Lying Down Measurement a. Lie on your back. b. Place your arm straight along your side with your palm upside. c. The cuff should be placed at the same level as your heart.

6. Taking Your Blood Pressure Reading

a. After applying the cuff and with your body in a comfortable position, press the “START” button. A beep is heard and all display characters are shown for self- test. See Fig. 6-1. Please contact the service centre if a segment is missing. b. Then the current memory bank (U1 or U2) is ashing. See Fig. 6-2. Press the “MEM” button to change to the other bank. See Fig. 6-3. Conrm your selec- tion by pressing the “START” button. The current bank will also be conrmed automatically after 5 seconds with no operation. Fig. 6-1 Fig. 6-2 Fig. 6-3 c. After selecting the memory bank, the monitor starts to seek zero pressure. See Fig. 6-4. d. The monitor inates the cuff until sufcient pressure has built up for a meas- urement. 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 Fig. 6-5 & 6-6. The result will be automatically stored in the current memory bank. Fig. 6-4 Fig. 6-5 Fig. 6-6PC-BMG3019_IM_new4 09.07.19

e. After measurement, the monitor will turn off automatically after 1 minute of no operation. You can also press the “START” button to turn off the monitor manually. f. 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.

7. Displaying Stored Results

a. After the measuring, you can review the measurements in the current mem- ory bank by pressing the button “MEM”. Now the LCD displays the amount of the results in the current bank. See Fig. 7-1. Fig. 7-1 Fig. 7-2 Fig. 7-3 b. You can also press the “MEM” button in Clock Mode to display the stored results. The current memory bank will ash and the amount of results in this bank will be displayed. See Fig. 7-2 Press the “START” button to change to the other bank. See Fig. 7-3. Conrm your selection by pressing the “MEM” button. The current bank will also be conrmed automatically after 5 seconds with no operation. c. After selecting the memory bank, the LCD will display the average value of the last three results in this bank. See Fig. 7-4 & 7-5. If no results are stored, the LCD will show dashes as shown in Fig. 7-6. Fig. 7-4 Fig. 7-5 Fig. 7-6PC-BMG3019_IM_new4 09.07.19

d. When the average is displayed and you press the “MEM” button, the most recent result will be displayed. See Fig. 7-7. Then the blood pressure and the pulse rate will be shown individually. Possibly the irregular heartbeat symbol may ash. See Fig. 7-8 & 7-9. Press the “MEM” button again to display the next result. See Fig. 7-10. In this way, repeatedly pressing the “MEM” button displays the respective results measured previously. Fig. 7-7 Fig. 7-8 Fig. 7-9 Fig. 7-10 e. When displaying the stored results, the monitor will turn off automatically after 1 minute of no operation. You can also press the “START” button to turn off the monitor manually.

8. Deleting Measurements from the Memory

When any result (except average reading of the last three results) is displayed and you keeping pressing the “MEM” button for three seconds, all results in the current memory bank will be deleted after three “beeps”. The LCD will show Fig. 8; pressing the “MEM” or the “START” button will turn off the monitor.

9. 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.) also must be taken into consideration. Consult with your physician for accurate assessment, and never change your treatment by yourself. Fig. 8PC-BMG3019_IM_new4 09.07.19

Slightly increased blood pressure 120 Normal

The appliance 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 specied in part “Specications”. 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.

11. Troubleshooting (1)

Problem Possible cause Solution LCD Display shows abnormal result The cuff position was not correct or it was not properly tightened. Apply the cuff correctly and try again. Body posture was not correct during testing. Review the section “Body posture during measurement” of the instructions and try again. 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 elec- tronic sphygmomanometer.PC-BMG3019_IM_new4 09.07.19

Problem Possible cause Solution LCD shows the symbol for a low battery Low battery Change the batteries LCD shows “Er 0” Pressure system is unsta- ble 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 ination. Apply the cuff cor- rectly and try again. LCD shows “Er 4” Pneumatic system leakage or cuff is too loose during ination. LCD shows “Er 5” Cuff pressure above 300 mm Hg Measure again after ve minutes. If the monitor is still abnor- mal, 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” Appliance parameter checking error LCD shows “Er A” Pressure sensor parameter error No response when you press a button or load batteries. Incorrect operation or strong electromagnetic interference. Take out batteries for ve minutes, and then reinstall all batteries.PC-BMG3019_IM_new4 09.07.19

1. Do not drop this monitor nor subject it to strong impacts.

2. Avoid high temperatures and direct sunlight. Do not immerse the monitor in

water as this will result in damage to the monitor.

3. If this monitor was stored at a temperature near the freezing point, allow it to

come to room temperature before use.

4. 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. 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.

5. Do not attempt to disassemble this monitor.

6. Not servicing / maintenance while the monitor is in use.

7. If you do not use the monitor for a long time, please remove the batteries.

8. It is recommended the performance should be checked every 2 years or after

repair. Please contact the service centre.

9. Clean the monitor with a dry, soft cloth or a soft cloth squeezed well after mois-

tened with water, diluted disinfectant alcohol, or diluted soapsuds.

10. No component in the monitor can be serviced by the user. 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 repairable can be supplied.

11. The monitor can maintain the safety and performance characteristics for a mini-

mum of 10,000 measurements or three years, and the cuff integrity is maintained after 1,000 open-close cycles of the closure.

12. It is recommended that the cuff should be disinfected 2 times every week if

needed (for example, in a hospital or in a clinic). Wipe the inner side (the side that contacts skin) of the cuff with a soft cloth moistened with ethyl alcohol (75 - 90 %) and squeezed, then dry the cuff by airing. Explanation of Symbols on Appliance Symbol for “THE OPERATION GUIDE MUST BE READ” (Symbol = white with blue background) Symbol for “WARNING”PC-BMG3019_IM_new4 09.07.19

Symbol for “TYPE BF APPLIED PARTS” (the cuff is a type BF applied part) Symbol for “ENVIRONMENT PROTECTION” - Waste electrical products should not be disposed of with household waste. Please recycle where fa- cilities exist. Check with your local Authority or retailer for recycling advice. Symbol for “MANUFACTURER” The CE marking indicates the conformity with the essential require- ments of Medical Device directive 93 / 42 / EEC. Symbol for “DATE OF MANUFACTURE” Symbol for “EUROPEAN REPRESENTATION”

Symbol for “SERIAL NUMBER” / “LOT NUMBER” IP20 Symbol for “Degree of protection according to IP (International Protection)” Symbol for “KEEP DRY” In the event of queries, contact: European Representation: iHealthLabs Europe SAS 36 rue de Ponthieu, 75008 Paris, France Importer: CTC Clatronic International GmbH Industriering Ost 40 47906 Kempen / Germany Manufacturer: Andon Health Co., Ltd. No.3 Jinping Street, YaAn Road, Nankai District, Tianjin 300190, ChinaPC-BMG3019_IM_new4 09.07.19

Electromagnetic Compatibility Information Table 1 - Emission Phenomenon Compliance Electromagnetic environment RF emissions CISPR 11 Group 1, Class B Home healthcare environment Harmonic distortion

Class A Home healthcare environment Voltage uctuations and icker

Compliance Home healthcare environment Table 2 - Enclosure Port Phenomenon Basic EMC standard Immunity test levels Home Healthcare Environment Electrostatic Discharge IEC 61000-4-2

15 kV air Radiated RF / EM eld IEC 61000-4-3 10 V/m 80 MHz - 2.7 GHz 80 % AM at 1 kHz Proximity elds from RF wireless communications equipment IEC 61000-4-3 Refer to table 3 Rated power frequency magnetic elds

Table 3 - Proximity Fields from RF Wireless Communications Equipment Test frequency (MHz) Band (MHz) Immunity test levels Professional healthcare facility environment 385 380 - 390 Pulse modulation 18 Hz, 27 V/m 450 430 - 470 FM,

5 kHz deviation, 1 kHz sine, 28 V/m

5 kHz, sinus 1 kHz, 28 V/m

.Andon Health Co., Ltd ,No.3 Jinping Street, YaAn Road Nankai District, Tianjin 300190, China CTC Clatronic International GmbH Industriering Ost 40 Kempen/Germany

6-7 5-7 4-7 . . "MEM" . 7-7 . "MEM" 9-7 8-7 . . "MEM" 10-7 8-7 7-7 10-7 9-7

.1-7 . .MEM 3-7 2-7 1-7 . . "MEM" .3-7 . "START" 2-7 .

. ."START" . 1-6 . . "MEM" 2-6 .(U2 U1) ."START" 3-6 .