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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