PCBMG 3018 - Blood pressure monitor ProfiCare - Free user manual and instructions

USER MANUAL PCBMG 3018 ProfiCare

5. Body Posture during Measurement ..........................................157

8. Deleting Measurements from the Memory ................................160

• Maintenance p. 165
• Explanation of Symbols on Appliance p. 167
• Electromagnetic Compatibility Information 46 PC-BMG 3018_IM_new 08.07.19 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 identical multiple blood pressure readings. 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 inter- ference, 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 Button MEM 2 Button START 3 Cuff 4 Battery compartment 5 Colour indicator 6 LCD display147 PC-BMG 3018_IM_new 08.07.19 7 Memory Indicator 8 Date / Time Display (Alternating) 9 Systolic Pressure p. 1691

Diastolic Pressure / Pulse Rate Display (Alternating) 11 Ready to inate Indicator 12 Irregular Heartbeat Symbol 13 Blood Pressure Level Classication Indicator 14 Low Battery Indicator Intended Use The fully automatic electronic sphygmomanometer is for use by medical professionals or at home. It is a non-invasive blood pressure measuring system intended to measure the diastolic and systolic blood pressures and the pulse rate of an adult individual by using a non-invasive technique in which an inatable cuff is wrapped around the wrist. 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 automati- cally and non-invasively. The LCD display will show blood pressure and pulse rate. The most recent 2 × 60 measurements can be stored in the memory with date and time stamp. The monitor can also show the average reading of the last three measurements.148 PC-BMG 3018_IM_new 08.07.19 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 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: Electro- magnetic 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-inva- sive 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), ISO 81060-2: 2013 (Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type). Specications

1. Product name: Blood pressure monitor

2. Model: PC-BMG 3018 (KD-738BR)

3. Classication: Internally powered, Type BF applied part, IP22 (1.

Safeguard against touching with a nger and penetration of for- eign objects with Ø ≥ 12.5 mm; 2. Safeguard against falling drip water when the casing is sloped at an angle of up to 15 °), No AP or APG, Continuous operation149 PC-BMG 3018_IM_new 08.07.19

6. Weight: Approx. 111 g (batteries excluded)

8. Memory volume: 2 × 60 measurements with time and date stamp

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 (- 4 ° to 122 °F)

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 bag150 PC-BMG 3018_IM_new 08.07.19 Notes

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

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 each time on the same wrist.

6. Please always relax at least 1 or 1.5 minutes between meas-

urements 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

2) The application of the cuff on any limb where intravascular ac-

cess 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

4) Simultaneously used with other monitoring medical equip-

ments on the same limb;

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 patients151 PC-BMG 3018_IM_new 08.07.19 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 measurement.

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 pre- scribed 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 interfer- ence 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 procedure 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 %.152

PC-BMG 3018_IM_new 08.07.19

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 manufac-

turer, 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.

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

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 communi- cations. 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 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.153 PC-BMG 3018_IM_new 08.07.19 - Consult the dealer or an experienced radio / TV technician for help.

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

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 tempera- ture (there will be low blood ow to the measurement position).

21. The appliance would not apply to the patients who use an arti-

cial 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

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.

26. This appliance complies with part 15 of the FCC Rules. Opera-

tion 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.154 PC-BMG 3018_IM_new 08.07.19 Setup and Operating Procedures

1. Inserting the Batteries

a. Open battery cover at the back of the monitor. b. Insert 2 batteries of the type “AAA”. Please pay attention to polarity. c. Close the battery cover. When the LCD shows the battery symbol , replace all batter- ies 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 uid to get in your eyes. If it should get in your eyes, immediately 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. 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 button155 PC-BMG 3018_IM_new 08.07.19 “MEM” to increase the number. Hold the button “MEM” depressed, the number will increase rapidly. Fig. 2- 1 Fig. 2-2 Fig. 2-3 c. You can turn off the monitor by pressing the “START” button when the minutes 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.

3. 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 brack- ets 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.156 PC-BMG 3018_IM_new 08.07.19

4. Applying the Cuff

a. Place the cuff around a bare wrist 1 - 2 cm above the wrist joint on the palm side of the wrist. b. 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. c. The cuff must be neither too tight nor too loose. Notes:

1. Please refer to the cuff circumference range in

“Specications” to make sure that the appropri- ate cuff is used.

2. Measuring on same wrist each time.

3. Do not move your arm, body, or the monitor during meas-

4. Stay quiet, calm for 5 minutes before blood pressure

5. 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.157 PC-BMG 3018_IM_new 08.07.19

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. 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.

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 selection 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. 6-3158 PC-BMG 3018_IM_new 08.07.19 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 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 Fig. 6-5 & 6-6. The result will be automati- cally stored in the current memory bank. Fig. 6- 4 Fig. 6-5 Fig. 6-6 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 memory bank by pressing the button “MEM”. Now the159 PC-BMG 3018_IM_new 08.07.19 LCD displays the amount of the results in the current bank. See Fig. 7-1 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 sec- onds with no operation. Fig. 7-1 Fig. 7-2 Fig. 7-3 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. 7-6160 PC-BMG 3018_IM_new 08.07.19 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. Fig. 8161 PC-BMG 3018_IM_new 08.07.19

9. Assessing High Blood Pressure for Adults

The following guidelines for assessing high blood pressure (with- out 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 consid- eration. Consult with your physician for accurate assessment, and never change your treatment by yourself. Blood Pressure Classication for Adults Blood pressure classication SYS (mmHG) DIA (mmHG) Colour indicator Optimal < 120 < 80 Green Normal 120 - 129 80 - 84 Green High - normal 130 - 139 85 - 89 Green Hypertension level 1 140 - 159 90 - 99 Yellow Hypertension level 2 160 - 179 100 - 109 Orange Hypertension level 3 ≥ 180 ≥ 110 Red Denition and classication of the blood pressure values according to WHO / ISH162 PC-BMG 3018_IM_new 08.07.19 Systolic (mmHG) 180 Severe hypertension (level 3) 160 Hypertension (level 2)

Slightly increased blood pressure 120 Normal

Diastolic (mmHG) Note: It is not intended to provide a basis of any type of rush toward emergency conditions / diagnosis based on the colour scheme and that the colour scheme is meant only to discriminate between the different levels of blood pressure.

10. Technical Alarm Description

The appliance will show “HI” or “Lo” as technical alarm on LCD with no delay if the determined blood pressure (systolic or dias- tolic) 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.163 PC-BMG 3018_IM_new 08.07.19 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 electronic sphygmo- manometer.164 PC-BMG 3018_IM_new 08.07.19

12. Troubleshooting (2)

Problem Possible cause Solution LCD shows the symbol for a low battery Low battery Change the batteries LCD shows “Er 0” Pressure system is unstable before meas- urement. 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 correctly and try again. LCD shows “Er 4” Pneumatic system leak- age or cuff is too loose during ination.165 PC-BMG 3018_IM_new 08.07.19 Problem Possible cause Solution LCD shows “Er 5” Cuff pressure above 300 mm Hg 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” Appliance parameter checking error LCD shows “Er A” Pressure sensor param- eter 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. Maintenance

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

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.166 PC-BMG 3018_IM_new 08.07.19

4. The monitor requires 6 hours to warm from the minimum storage

temperature between uses until the monitor is ready for its in- tended 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.

Do not attempt to disassemble this monitor.

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

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 moistened 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 charac-

teristics 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.

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.167 PC-BMG 3018_IM_new 08.07.19 Explanation of Symbols on Appliance Symbol for “THE OPERATION GUIDE MUST BE READ” (Symbol = white with blue background) Symbol for „WARNING“ 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 house- hold waste. Please recycle where facilities exist. Check with your local Authority or retailer for recycling advice. Symbol for “MANUFACTURER” The CE marking indicates the conformity with the essential requirements of Medical Device directive 93 / 42 / EEC. Symbol for “DATE OF MANUFACTURE” Symbol for “EUROPEAN REPRESENTATION”

Symbol for “SERIAL NUMBER” / “LOT NUMBER”168 PC-BMG 3018_IM_new 08.07.19 IP22 Symbol for “Degree of protection according to IP (International Protection)” 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, China169 PC-BMG 3018_IM_new 08.07.19 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

15 kV air Radiated RF / EM eld

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

30 A/m 50 Hz or 60 Hz171 PC-BMG 3018_IM_new 08.07.19 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

iHealthLabs Europe SAS

Andon Health Co., Ltd. No.3 Jinping Street, YaAn Road, Nankai District, Tianjin 300190, China263 PC-BMG 3018_IM_new 08.07.19

.3-7 . "START" 2-7273

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