Andon Health 721 Blood Pressure Monitor User Manual

Andon Health Co., Ltd Blood Pressure Monitor

User Manual

DN:ZRY721-SMSY01 V1.0 Operation Guide Template version:1 History Revision NO Revision date Revision Description Version Drafter Approver 01 2015/08/13 Originated V1.0 李甲一 张飞
DN:ZRY721-SMSY01 V1.0 Operation Guide Template version:1 Operation Guide (V1.0) Product/project name：Blood Pressure Monitor BC 57 (KD-721) Project number： Drafted by: Date Reviewed by: Date Approved by: Date Model name：
DN:ZRY721-SMSY01 V1.0 Operation Guide Template version:1 1/18 MODEL BC 57 (KD-721) Fully Automatic Wrist Cuff Blood Pressure Monitor (ELECTRONIC SPHYGMOMANOMETER) OPERATION GUIDE __________________________________________________________________________ INDEX IMPORTANT INFORMATION ......................................................................... 2 CONTENTS AND DISPLAY INDICATORS ..................................................... 2 INTENDED USE .............................................................................................. 3 CONTRAINDICATION ..................................................................................... 3 PRODUCT DESCRIPTION .............................................................................. 3 SPECIFICATIONS ........................................................................................... 4 NOTICE ........................................................................................................... 4 SETUP AND OPERATING PROCEDURES .................................................... 7 1. BATTERY LOADING .................................................................................. 7 2. CLOCK AND DATE ADJUSTMENT ........................................................... 7 3. CONNECTING THE CUFF TO THE MONITOR .......................................... 9 4. APPLYING THE CUFF ................................................................................ 9 5. BODY POSTURE DURING MEASUREMENT .......................................... 10 6. TAKING YOUR BLOOD PRESSURE READING ...................................... 10 7. DISPLAYING STORED RESULTS ........................................................... 11 8. DELETING MEASUREMENTS FROM THE MEMORY ............................. 12 9. ASSESSING HIGH BLOOD PRESSURE FOR ADULTS ......................... 12 10. TECHNICAL ALARM DESCRIPTION ..................................................... 12 11. TROUBLESHOOTING (1) ....................................................................... 13 12. TROUBLESHOOTING (2) ....................................................................... 13 MAINTENANCE ............................................................................................ 14 EXPLANATION OF SYMBOLS ON UNIT ..................................................... 14 WARRANTY INFORMATION ........................................................................ 15 SERVICE CENTER ....................................................................................... 15 ELECTROMAGNETIC COMPATIBILITY INFORMATION ............................ 15
DN:ZRY721-SMSY01 V1.0 Operation Guide Template version:1 2/18 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
DN:ZRY721-SMSY01 V1.0 Operation Guide Template version:1 3/18 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. 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 measurements can be stored in the memory with date and time stamp. The voice function will ease the operation. The Electronic Sphygmomanometers corresponds to the below standards: IEC 60601-1:2005 corr.1(2006)+corr.2(2007)/EN 60601-1：2006/A11: 2011 (Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance), IEC60601-1-2:2007/EN 60601-1-2:2007 /AC:2010 (Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests), IEC 80601-2-30：2009+Cor.2010(Medical electrical equipment –Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers)EN 1060-1: 1995 + A1: 2002 + A2: 2009 (Non-invasive sphygmomanometers - Part 1: General requirements), EN 1060-3: 1997 + A1: 2005 + A2: 2009 (Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems).
DN:ZRY721-SMSY01 V1.0 Operation Guide Template version:1 4/18 SPECIFICATIONS 1. Product name: Blood Pressure Monitor 2. Model: BC 57 (KD-721) 3. Classification: Internally powered, Type BF applied part,IPX0,No AP or APG,Continuous operation 4. Machine size: Approx. 78mm×60mm×28mm 5. Cuff circumference: 14cm ~ 19.5cm(5 1/2″~ 7 11/16″) 6. Weight: Approx. 67g (2 3/8oz.) (exclude batteries) 7. Measuring method: Oscillometric method, automatic inflation and measurement 8. Memory volume: 2×60 times with time and date stamp 9. Power source: batteries: 2 ×1.5V SIZE AAA 10. Measurement range: Cuff pressure: 0-300mmHg Systolic: 60-260mmHg Diastolic: 40-199mmHg Pulse rate: 40-180 beats/minute 11. Accuracy: Pressure: ±3mmHg Pulse rate: ±5% 12. Environmental temperature for operation: 10℃～40℃(50℉～104℉) 13. Environmental humidity for operation: ≤85%RH 14. Environmental temperature for storage and transport: -20℃～50℃(-4℉～122℉) 15. Environmental humidity for storage and transport: ≤85%RH 16. Environmental pressure: 80kPa-105kPa 17. Battery life: Approx 170 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 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 wrist. 7. Consult your physician if you have any doubt about below cases:
DN:ZRY721-SMSY01 V1.0 Operation Guide Template version:1 5/18 1) The application of the cuff over a wound or inflammation 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 wrist on the side of a mastectomy; 4) Simultaneously used with other monitoring medical equipments on the same limb; 5) Need to check the blood circulation of the user. 8. 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. 9. Do not use this unit 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 prescribed by the American National Standard Institute, Electronic or automated sphygmomanometers. 11. 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. 12. 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: 1) The coefficient of variation (CV) of pulse period >25%. 2) 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. 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. 14. Please do not share the cuff with other infective person to avoid cross-infection. 15. 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.
DN:ZRY721-SMSY01 V1.0 Operation Guide Template version:1 6/18 16. This device complies with Part 15 of the FCC Rules. Its 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. 17.Attention that changes or modification not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. 18.Cet appareil est conforme à la section 15 des réglementations de la FCC. Le fonctionnement de l’appareil est sujetaux deux conditions suivantes : (1) cet appareil ne doit pas provoquer d’interférences néfastes, et (2) cet appareil doit tolérer les interférences reçues, y compris celles qui risquent de provoquer un fonctionnement indésirable. 20.Measurements are not possible in patients with a high frequency of arrhythmias. 21.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.) 22.Motion, trembling, shivering may affect the measurement reading. 23.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). 24.The device would not apply to the patients who use an artificial heart and lung (there will be no pulse) 25.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, enal diseases. 19.Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and maximum (or lesser) gain approved for the transmitter by Industry Canada. To reduce potential radio interference to other users, the antenna type and its gain should be so chosen that the equivalent isotropically radiated power (e.i.r.p.) is not more than that necessary for successful communication.
DN:ZRY721-SMSY01 V1.0 Operation Guide Template version:1 7/18 SETUP AND OPERATING PROCEDURES 1. BATTERY LOADING a. Open battery cover at the back of the monitor. b. Load two “AAA” size batteries. Please pay attention to polarity. c. 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 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. At first the Blood Pressure Monitor is totally off, once you insert the battery, the Blood Pressure Monitor will enter Clock and Date Adjustment Mode. b. If the time of the device is already set and need to be changed, adjustment can be reached by pressing the “START/STOP” button for 5 seconds in Standby Mode. c. In Clock and Date Adjustment Mode , the time format will blink at first , see picture2-1 .If the monitor has no result stored in the current user ,the default time format is 24h(Europe Version) and the default clock and date is 2015-1-1 1:00, else the default time format, clock and date is same as the most recent result’s. d. Press the button “START/STOP” repeatedly, the year (first usage: default is 2015, range is 2015~2099), month, day, hour and minute will blink in turn, see picture 2- 2& 2-3 & 2-4 & 2-5 & 2-6. While the number is blinking, press the button “MEM” to increase the number, keep on pressing the button "MEM", the number will increase faster. Picture 2-1 Picture 2-2 Picture 2-3
DN:ZRY721-SMSY01 V1.0 Operation Guide Template version:1 8/18 Picture 2-4 Picture 2-5 Picture 2-6 e. After adjusted clock and date,the LCD will blink “bt” see picture 2-7.Press M2 will alter START/STOP of bluetooth.If bluetooth is ON,a sign of will flash. Picture 2-7 f. During adjusting clock and date, the monitor will go back to Standby Mode automatically when no button will be pressed within 30 seconds. g. You can turn off the monitor by pressing “START/STOP” button when the minute is blinking, then the time and date is confirmed. Note: 2.1 The clock format could be set by user. 2.2 Position of month and day depends on 12h or 24h time setting: 24h, day/month (See Picture 2-8); 12h, month/day (See Picture 2-9). Picture 2-8 Picture 2-9 2.3 All of the LCD illustrations are 24 hour format in the Operation Guide, except for the picture 2-8. 2.4 Table 1 instructs the conversion relations between 24 hour format and 12 hour format. Table 1 24 hour format 12 hour format 24 hour format 12 hour format
DN:ZRY721-SMSY01 V1.0 Operation Guide Template version:1 9/18 0:00 12:00 AM 12:00 12:00 PM 1:00 1:00 AM 13:00 1:00 PM 2:00 2:00 AM 14:00 2:00 PM 3:00 3:00 AM 15:00 3:00 PM 4:00 4:00 AM 16:00 4:00 PM 5:00 5:00 AM 17:00 5:00 PM 6:00 6:00 AM 18:00 6:00 PM 7:00 7:00 AM 19:00 7:00 PM 8:00 8:00 AM 20:00 8:00 PM 9:00 9:00 AM 21:00 9:00 PM 10:00 10:00 AM 22:00 10:00 PM 11:00 11:00 AM 23:00 11:00 PM 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 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. 4. APPLYING THE CUFF a. Place the cuff around a bare wrist 1-2cm 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. Note: • Please refer to the cuff circumference range in “SPECIFICATIONS”
DN:ZRY721-SMSY01 V1.0 Operation Guide Template version:1 10/18to make sure that the appropriate cuff is used. • Measuring on same wrist each time. • Do not move your arm, body, or the monitor during measurement. • Stay still, calm for 5 minutes before blood pressure measurement. • 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. 5. BODY POSTURE DURING MEASUREMENT Sitting Comfortably Measurement a. Be seated with your feet flat on the floor, and don’t cross your legs. b. Place palm upside in front of you on a flat surface such as a desk or table, with your elbow resting on a chair or 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 your body is in a comfortable position, press the “START/STOP” button. A beep is heard and all display characters are shown for self-test. You can check the LCD display according to the right picture. Please contact the service center if segment is missing. b. 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. c. Then 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. The blood pressure classification indicator and Irregular heartbeat symbol (if any) will blink on the screen. The result will be automatically stored in the monitor. d. After measurement, the monitor will turn off automatically after 1 minute of no operation. e. If the bluetooth function is enabled, you can press “START/STOP” button to enter the Bluetooth Transmittion Mode.Then press “START/STOP” button to shutdown.If the bluetooth function is disabled, pressing “START/STOP” button will turn it off directly. f. During measurement, you can press the “START/STOP” button to turn off the monitor manually. Note: Please consult a health care professional for interpretation of pressure measurements.
DN:ZRY721-SMSY01 V1.0 Operation Guide Template version:1 11/187. DISPLAYING STORED RESULTS a. In StandBy Mode, press “MEM” button, the monitor will blink sign of current group.Press “MEM” button to switch group,press “START/STOP” to confirm current group.Then the amount of results in current user memory zone will be displayed. See picture 8. Then LCD will display the average value of all results in the current user memory zone.If the bluetooth function is on, the device will wait for pairing for 30s. See picture 8-1. If no result stored in the current user memory zone, LCD will display “0” for blood pressure and pulse rate. See picture 8-2. b. 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 8-3. 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. See picture 8-4. Picture 8 Picture 8-1 Picture 8-2 Picture 8-3 Picture 8-4 c. 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. See picture 8-5. 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 8-6. Picture 8-5 Picture 8-6 Picture 8-7 Picture 8-8 Picture 8-9 d. Press “MEM” button again, the most recent result will be displayed with date and time stamp. See picture 8-7. Irregular heartbeat symbol (if any) and blood pressure classification indicator will blink at the same time. If the monitor has no result stored in the current user memory zone, the LCD will display “0” for blood pressure and pulse rate. See picture 8-8. e. Press “MEM” button again to review the next result. See picture 8-9. In this way, repeatedly pressing the “MEM” button displays the respective results measured previously. f. When reviewing the results, the monitor will turn off automatically after 1 minute of no operation. You can also press the “START/STOP” button to turn off the monitor manually.
DN:ZRY721-SMSY01 V1.0 Operation Guide Template version:1 12/18 Note: When the monitor displaying the measurement, the classification color indicator can be shown different color according to the systolic pressure and diastolic pressure. Refer to the “ASSESSING HIGH BLOOD PRESSURE FOR ADULTS” section 8. DELETING MEASUREMENTS FROM THE MEMORY When any average value is displaying, keeping on pressing button “MEM” for three seconds, all results will be deleted after three “beep”. When any result is displaying, keeping on pressing button “MEM” for three seconds, current result will be deleted after three “beep”. Press the button “START/STOP”, the monitor will turn off. 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.) 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. 10. 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.
DN:ZRY721-SMSY01 V1.0 Operation Guide Template version:1 13/18The 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 “BODY POSTURE DURING 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. 12. TROUBLESHOOTING (2) PROBLEM POSSIBLE CAUSE SOLUTION LCD shows low battery symbol Low Battery Change the batteries LCD shows “EE 0” Pressure system is unstable before measurement Don’t move and try again. LCD shows “EE 1” Fail to detect systolic pressure Fail to detect diastolic pressure LCD shows “EE 2” Pneumatic system blocked or cuff is too tight during inflation Apply the cuff correctly and try again Pneumatic system leakage or cuff is too loose during inflation LCD shows “EE 3” More than 3 minutes with cuff pressure above 15 mmHg Measure again after five minutes. If the monitor is still abnormal, please contact the local distributor or the factory. LCD shows “EE 4” EEPROM accessing error LCD shows “EE 5” Device parameter checking error LCD shows “EE 6” Pressure sensor parameter error LCD shows “EE 8” Cuff pressure above 300mmHg LCD shows “EE 7” Bluetooth Error Take out batteries for five minutes, and then reinstall all batteries. No response when you press button or load battery. Incorrect operation or strong electromagnetic interference.
DN:ZRY721-SMSY01 V1.0 Operation Guide Template version:1 14/18MAINTENANCE 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 qualified 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 contacts skin) of the cuff by a soft cloth squeezed after moistened with Ethyl alcohol (75-90%), then dry the cuff by airing. 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”
DN:ZRY721-SMSY01 V1.0 Operation Guide Template version:1 15/18EC REP 47 Spenlow House Bermondsey London SE16 4SJ Symbol for “EUROPEAN REPRESENTATION” Symbol for “SERIAL NUMBER” Symbol for “KEEP DRY” WARRANTY INFORMATION Only charge the cost of components and transport. SERVICE CENTER ANDON HEALTH CO., LTD. No. 3 Jinping Street, YaAn Road, Nankai District, Tianjin 300190, China. Tel: 86-22-60526081 Lotus Global Co., Ltd. 1 Four Seasons Terrace West Drayton, Middlesex, London, UB7 9GG,United Kingdom Tel: +0044-20-75868010 Fax: +0044-20-79006187 IMPORTANT INFORMATION REQUIRED BY THE R&TTE This product is approved in accordance to R&TTE directive transmitter. interference This product complies with Industry Canada. IC: RSS-210 IC NOTICE This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc 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. This product is approved in accordance to R&TTE directive transmitter. Hereby, [ANDON HEALTH CO., LTD.], declares that this [ZRY721 ] is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC. See part Directive 1999/5/EC declaration of conformity ELECTROMAGNETIC COMPATIBILITY INFORMATION Table 1 EC REP 47 Spenlow House Bermondsey London SE16 4SJ
DN:ZRY721-SMSY01 V1.0 Operation Guide Template version:1 16/18For all ME EQUIPMENT and ME SYSTEMS Guidance and manufacture’s declaration - electromagnetic emissions The ZRY721 is intended for use in the electromagnetic environment specified below. The customer or the user of the ZRY721 should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions CISPR 11 Group 2 The ZRY721 must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. RF emissions CISPR 11 Class B The ZRY721 is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Harmonic emissions IEC 61000-3-2 Not applicable Voltage fluctuations/ flicker emissions IEC 61000-3-3 Not applicable Table 2 For all ME EQUIPMENT and ME SYSTEMS Guidance and manufacturer’s declaration - electromagnetic immunity The ZRY721 is intended for use in the electromagnetic environment specified below. The customer or the user of the ZRY721 should assure that it is used in such an environment. IMMUNITY test IEC 60601test level Compliance level Electromagnetic environment - guidance Electrostatic discharge (ESD) IEC 61000-4-2 ± 6 kV contact ± 8 kV air ± 6 kV contact ± 8 kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Table 3 For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacturer’s declaration - electromagnetic immunity The ZRY721 is intended for use in the electromagnetic environment specified below. The customer or the user of the ZRY721 should assure that it is used in such an environment. IMMUNITY test IEC 60601test level Compliance level Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the ZRY721, including cables, than the recommended separation distance calculated from the
DN:ZRY721-SMSY01 V1.0 Operation Guide Template version:1 17/18 Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.5 GHz 3 V/m equation applicable to the frequency of the transmitter. Recommended separation distance：：：： 80 MHz to 800 MHz 800 MHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the ZRY721 is used exceeds the applicable RF compliance level above, the ZRY721 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the ZRY721. Pd 2.1=Pd 3.2=
DN:ZRY721-SMSY01 V1.0 Operation Guide Template version:1 18/18b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Table 4 For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the ZRY721 The ZRY721 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ZRY721 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ZRY721 as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz 0,01 0.12 0.12 0.23 0,1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Pd 2.1=Pd 2.1=Pd 3.2=

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