Gima LS808-BS Manual Download Page 26

54

COMPLIED STANDARDS LIST

Risk management

EN ISO 14971:2012 / ISO 14971:2007 Medical devices - Applica-

tion of risk management to medical devices

Labeling

EN ISO 15223-1:2016 / ISO 15223-1:2016  Medical devices. 

Symbols to be used with medical device labels, labelling and 

information to be supplied. Part 1 : General requirements

User manual

EN 1041:2008 +A1:2013 Information supplied by the manufactur-

er of medical devices

General Requirements 

for Safety

EN 60601-1:2006+A1:2013/ IEC 60601-1:2005+A1:2012 Medical 

electrical equipment - Part 1: General requirements for basic 

safety and essential performance

EN 60601-1-11:2015/ IEC 60601-1-11:2015 Medical electrical 

equipment - Part 1-11: General requirements for basic safety and 

essential performance - Collateral standard: Requirements for 

medical electrical equipment and medical electrical systems used 

in the home healthcare environment

Electromagnetic

compatibility

EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical 

equipment - Part 1-2: General requirements for basic safety and 

essential performance - Collateral standard: Electromagnetic 

disturbances - Requirements and tests

Performance

requirements

EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 

1: Requirements and test methods for non-automated measure-

ment type

EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers - 

Part 3: Supplementary requirements for electro-mechanical blood 

pressure measuring systems

IEC 80601-2-30:2009+A1:2013 Medical electrical equipment- 

Part 2-30: Particular requirements for the basic safety and 

essential performance of automated non-invasive sphygmoma-

nometers

Clinical investigation

EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: 

Test procedures to determine the overall system accuracy of 

automated non-invasive sphygmomanometers

ISO 81060-2:2013  Non-invasive sphygmomanometers - Part 2: 

Clinical validation of automated measurement type

Usability

EN 60601-1-6:2010+A1:2015/IEC 60601-1-6:2010+A1:2013 

Medical electrical equipment - Part 1-6: General requirements 

for basic safety and essential performance - Collateral standard: 

Usability

IEC 62366-1:2015 Medical devices - Part 1: Application of usabil-

ity engineering to medical devices

Software life-cycle 

processes

EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015

Medical device software - Software life-cycle processes

ENGLISH

Summary of Contents for LS808-BS

Page 1: ...MEDICAL PRODUCTS Guangdong Transtek Medical Electronics Co Ltd Zone A No 105 Dongli Road Torch Development District Zhongshan 528437 Guangdong China Made in China 32916 LS808 BS MDSS Medical Device S...

Page 2: ...DATA MANAGEMENT 44 Recall the Records 44 Delete the Records 46 INFORMATION FOR USER 47 Tips for Measurement 47 Maintenance 48 ABOUT BLOOD PRESSURE 49 What are systolic pressure and diastolic pressure...

Page 3: ...ntended for adult indoor use only Contraindications 1 The device should not be used by any person who may be suspected of or is pregnant 2 The device is not suitable for use on patients with implanted...

Page 4: ...r blood pressure When the device is used to measure patients who have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation the best result may occur with deviation P...

Page 5: ...use in the presence of a flamma ble anesthetic mixture with air of with oxygen or nitrous oxide Warning No servicing maintenance while the ME equipment is in use The patient is an intended operator Th...

Page 6: ...ort to Gima if any unexpected operation or events occur Keep the unit out of reach of infants young children or pets to avoid inhalation or swallowing of small parts It is dangerous or even fatal Be c...

Page 7: ...inks when the blue tooth is working Average value The average value of the latest three groups bood pressure value Memory Query Indicate it is in the memory mode and which group of memory it is User 1...

Page 8: ...sure Monitor 2 AC Adaptor LS808 BS Model BLJ06L060100P V 3 User Manual 4 Cuff 22cm 42cm Type BF Applied Part Please use Gima authorized cuff The size of the actual cuff please refer to the label on th...

Page 9: ...d for about 20 days Storge and use the blood pressure monitor at the cool dry and ventilated environment Avoid to approach to the fire and the heat source or it will cause the battery explode Only can...

Page 10: ...Setting the Time Date and Unit To ensure the stored measurement result has correct time record please set time and unit before device is used Before use switch the button to the ON side to turn on th...

Page 11: ...39 3 Press User 1 button again to confirm YEAR Then the numeral representing MONTH blinks 4 Repeat step 2 and 3 to confirm MONTH and DAY 5 Repeat step 2 and 3 to confirm HOUR and MINUTE ENGLISH...

Page 12: ...ure Monitor with Your Device 1 Turn on Bluetooth and the app Make sure both are ON when pair up is proceeding 2 In the search device interface please select the device to pair up 3 When the monitor is...

Page 13: ...will shut off after Pair up process is complete Bluetooth Module No LS51802 RF Frequency Range 2402 MHz to 2480 MHz Output Power Range 0 dBm Supply Voltage 1 8 3 6 V Transmitting Distance 10 meters Li...

Page 14: ...n in your arm use the other one 2 Roll or push up your sleeve to expose the skin 3 Apply the cuff to your arm with your palm facing up 4 Position the edge of the cuff about 2cm 3cm from elbow 5 Fasten...

Page 15: ...sure data Take User 1 for example Note Select the same user on your app and BPM to take the measurement or the measurement data won t be transmitted to the app 1 When the monitor is off press the User...

Page 16: ...DATA MANAGEMENT Recall the Records 1 When the monitor is off please press the Query button to show the average value of the latest three records If the records are less than three groups it will displ...

Page 17: ...is January 2nd is 8 00 CAUTION The most recent record 1 is shown first Each new measurement is assigned to the first 1 record All other records are pushed back one digit e g 2 becomes 3 and so on and...

Page 18: ...60 is dropped from the list Delete the Records 1 Hold pressing Query button for 3 seconds when the monitor is in the memory recall mode the dEL ALL User ID will flash on the display 2 Press Query to...

Page 19: ...taken in the following circumstances Within 1 hour after dinner or drinking Immediate measurement after tea coffee smoking Within 20 minutes after taking a bath When talking or moving your fingers In...

Page 20: ...t in a dry place and avoid the sunshine Avoid immersing it in the water Clean it with a dry cloth in case Avoid intense shaking and collisions Avoid dusty environment and unstable temperature surround...

Page 21: ...ysician can tell whether your blood pressure value has reached a dangerous point Irregular Heartbeat Detector An irregular heartbeat is detected when a heartbeat rhythm varies while the device is meas...

Page 22: ...the pressure will vary more 3 Wait at least 3 minutes for another measurement Why do I get a different blood pressure at home compared to the hospital The blood pressure is different even throughout...

Page 23: ...ust the cuff and relax for a moment and then measure again E 10 or E 11 shows The monitor detected motion talking or the pulse is too poor while measuring Relax for a moment and then measure again E 2...

Page 24: ...ange of 700 hPa to 1060 hPa Storage transportation condition Temperature 20 C to 60 C A relative humidity range of 93 non condensing at a water vapour pressure up to 50hPa Measurement perimeter of the...

Page 25: ...V Output 100 240V 50 60Hz 0 2Amax Input 6V 1000mA Contact Information Manufactured by Guangdong Transtek Medical Electronics Co Ltd Company Guangdong Transtek Medical Electronics Co Ltd Address Zone...

Page 26: ...al standard Electromagnetic disturbances Requirements and tests Performance requirements EN ISO 81060 1 2012 Non invasive sphygmomanometers Part 1 Requirements and test methods for non automated measu...

Page 27: ...l antennas should be used no closer than 30 cm 12 inches to any part of the equip ment LS808 BS including cables specified by the manufacturer Otherwise degradation of the performance of this equipmen...

Page 28: ...rrup tions and voltage variations on power supply input lines IEC 61000 4 11 0 UT 0 5 cycle At 0 45 90 135 180 225 270 and 315 0 UT 1 cycle and 70 UT 25 30 cycles Single phase at 0 0 UT 250 300 cycle...

Page 29: ...0 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse modulation b 18Hz 2 0 3 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation b 217Hz 2...

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