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Performance requirements and Clinical investigation: IEC 80601-2-30:2009 Medical
electrical equipment- Part 2-30: Particular requirements for the basic safety and essential
performance of automated non-invasive sphygmomanometers. ANSI/AAMI SP10:2002/A2:
2008 Manual, electronic, or automated sphygmomanometers
Software life-cycle processes: IEC/EN 62304:2006+AC: 2008 Medical device
software - Software life cycle processes
Usability: IEC 62366 Medical devices - Application of usability engineering to
medical devices (IEC 62366:2007) IEC 60601-1-6 Medical electrical equipment -
Part 1-6 : General requirements for basic safety and essential performance -
collateral standard : Usability

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Содержание Balance 0605

Страница 1: ...WRIST BLOOD PRESSURE MONITOR MANUAL Email info greatergoods com Phone 866 991 8494 VIDEO TUTORIAL greatergoods com 0605 Model 0605 ...

Страница 2: ...MENTS p 9 10 MEMORY MANAGING RECORDS p 11 12 TIPS MAINTENANCE p 13 14 ABOUT BLOOD PRESSURE p 15 16 IRREGULAR HEARTBEAT DETECTOR BATTERY CAUTIONS p 17 18 TROUBLESHOOTING p 19 20 DEVICE SPECIFICATIONS p 21 22 COMPLIED STANDARDS LIST FCC STATEMENT EMC GUIDANCE p 23 26 SAFETY INFORMATION INDICATIONS FOR USE p 27 32 WARRANTY p 33 ...

Страница 3: ...ted to creating 5 star products If we haven t delivered on our promise please contact us For the best possible experience with your product please visit greatergoods com 0605 WARNING No modification of this equipment is allowed ...

Страница 4: ...PULSE RATE NOTE While the monitor only has two buttons each button has two functions Throughout the manual you will see the buttons referred to by the function being described in that step e g Press and hold the POWER button to turn on then press the SET button to select your user and begin measuring ...

Страница 5: ...t of blood pressure Pulse per minute Beats per minute BPM Irregular Heartbeat Detection Irregular heartbeat Blood Pressure Grade Displays grade of blood pressure Low batteries Batteries are low and need to be replaced Current time Month Day Year Hour Minute User ID Start measurement and save the results for USER 1 or USER 2 Shaking alert Shaking will result in inaccurate measurements ...

Страница 6: ...5 MONITOR COMPONENTS cont BATTERY COMPARTMENT CUFF Type BF applied part Package Contents 1 Wrist Blood Pressure Monitor 2 2 AAA batteries 3 User manual ...

Страница 7: ...ttery cover Install the batteries by matching the correct polarity as shown here Always use the correct battery type 2 x AAA batteries Replace the cover Replace the batteries whenever the following happen appears The display dims The display does not light up ...

Страница 8: ... in the memory year 2014 2054 time format 24 H 12 H 1 When the monitor is off press and hold the POWER button for about 3 seconds to enter into setup mode The blinking numeral represents YEAR 2 Press the ARROW button to change the YEAR Each press will increase the numeral by 1 in a cycling manner Then press the SET button to confirm your selection and it will turn to the next step ...

Страница 9: ...IME FORMAT 24 hours or 12 hours HOURS MINUTES and the MEASUREMENT UNIT IMPORTANT Most doctors in the United States use mmHg millimeters of mercury as the measurement unit 4 After confirming the measurement unit the LCD will display all the settings you have done once again and then turn off ...

Страница 10: ...o your wrist with your palm facing up 4 Position the edge of the cuff about 1 5 cm away from your palm 5 Fasten the wrist cuff around your wrist leaving no extra room between the cuff and your skin If the cuff is too loose the measurement will not be accurate Sit upright comfortably and relax as much as possible with your legs uncrossed Make sure your arm is supported and the wrist monitor is leve...

Страница 11: ... first Press the ARROW button to change the user ID between User 1 and User 2 Press the SET button to confirm and it will finish the whole measurement for the selected user 2 Press the POWER button to power off otherwise the device will turn off within 1 minute LCD display Adjust to zero Inflating measuring Display and save the result ...

Страница 12: ...t of result date and time Press the ARROW button again and it will display the next record and so on During the process of displaying the results if there is no operation the blood pressure monitor will turn off after one minute Or you can press the POWER button to turn it off NOTE The record number date and time will display alternately NOTE For a meaningful comparison try to measure under simila...

Страница 13: ...tion screen Use the ARROW button to switch between users Use the SET button to select the user you want to view 2 Press and hold the SET button for 3 seconds the display will show dEL 3 Press ARROW to toggle between YES and NO Press SET to confirm the selection If YES is selected the unit will delete the records and turn off 4 If there is no record this display will show ...

Страница 14: ...uff in water TIPS FOR MEASUREMENT It can cause inaccuracy if the measurement is taken under the following circumstances Measuring within 1 hour of eating or drinking Measuring after tea coffee or smoking Measuring within 20 minutes after taking a bath Measuring when talking or moving your fingers Measuring in a very cold environment Measuring when needing to use the restroom ...

Страница 15: ...14 STANDARD CLASSIFICATION ...

Страница 16: ...he cycle which is called systolic pressure When the ventricles relax the blood pressure reaches its minimum value in the cycle which is called diastolic pressure Q Does it matter which wrist I use when measuring A It is acceptable to use either wrist when measuring However to obtain the most consistent readings possible it is suggested that you use the same wrist each time you measure your blood p...

Страница 17: ...ase make sure you measure your blood pressure under the same conditions each time you take a measurement Variations in pressure can also occur due to certain medicines being taken Waiting at least 3 minutes between measurements is recommended Q Why is the blood pressure I get from the hospital different from home A Your blood pressure can vary throughout the day due to many factors such as weather...

Страница 18: ... or equal to 15 this equipment will light up the IHB symbol on the screen when displaying the results NOTE The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heartbeat was detected during measurement Usually this is NOT a cause for concern However if the symbol appears often we recommend you seek medical advice Please note that the device does not repla...

Страница 19: ...ly to be used for some time The old batteries are harmful to the environment do not dispose with other daily trash Remove the old batteries from the device and follow your local recycling guidelines Do not dispose of batteries in fire Batteries may explode or leak ...

Страница 20: ...m or icon is showing Batteries are low E1 shows on screen The inflation is too low Refasten the cuff and then measure again E2 shows on screen The cuff is not secure Refasten the cuff and then measure again Refasten the cuff and then measure again Can t inflate the air during the process of measurement E3 shows on screen E4 shows on screen The cuff is too tight Refasten the cuff and then measure a...

Страница 21: ...and then measure again The monitor detected motion while measuring E10 or E11 shows on screen E20 shows on screen Pulse not detected Remove clothing covering the wrist or tighten the cuff and then measure again E21 shows on screen Incorrect measurement Relax for a moment and then measure again EExx shows on screen A calibration error occurred Retake the measurement If the problem persists contact ...

Страница 22: ...ement range Rated cuff pressure 0mmHg 300mmHg 0kPa 40kPa Measurement pressure SYS 60mmHg 230mmHg 8 0kPa 30 7kPa DIA 40mmHg 130mmHg 5 3kPa 17 3kPa Pulse value 40 199 beat minute Accuracy Pressure 5 C 40 C within 0 4 kPa 3 mmHg Pulse value 5 Normal working condition Temperature 5 C to 40 C Relative humidity 85 RH Atmospheric pressure 86 kPa to 106 kPa ...

Страница 23: ...imeter of the wrist About 5 3 in 8 4 in Net Weight Approx 105 g Excluding the dry cells External dimensions Approx 3 4in x 2 6in x 0 9in Exclude the cuff Mode of operation Continuous operation Degree of protection Type BF applied part Protection against ingress of water IP22 Software version V01 Device classification Internally Powered ME Equipment ...

Страница 24: ...01 1 2005 A1 2012 Medical electrical equipment Part 1 General requirements for basic safety and essential performance IEC 60601 1 11 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 compatibili...

Страница 25: ... AAMI SP10 2002 A2 2008 Manual electronic or automated sphygmomanometers Software life cycle processes IEC EN 62304 2006 AC 2008 Medical device software Software life cycle processes Usability IEC 62366 Medical devices Application of usability engineering to medical devices IEC 62366 2007 IEC 60601 1 6 Medical electrical equipment Part 1 6 General requirements for basic safety and essential perfor...

Страница 26: ...eds to be installed and put into service in accordance with the information provided in the user manual 2 Wireless communications equipment such as wireless home network devices mobile phones cordless telephones and their base stations and walkie talkies can affect this equipment and should be kept at least a distance d 3 3m away from the equipment Note As indicated in Table 6 of IEC 60601 1 2 200...

Страница 27: ...ol for DIRECT CURRENT Symbol for MANUFACTURE DATE 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 CAUTION These notes must be observed for advice or to prevent any damage to device ...

Страница 28: ...ons other than obtaining a blood pressure measurement Do not confuse self monitoring with self diagnosis This unit allows you to monitor your blood pressure Do not begin or end medical treatment without asking a physician for treatment advice If you are taking medication consult your physician to determine the most appropriate time to measure your blood pressure Never change a prescribed medicatio...

Страница 29: ...able anesthetic mixture with air of with oxygen or nitrous oxide This device cannot be used with HF surgical equipment at the same time This device is not intended for patient transports outside a healthcare facility Please do not attempt to repair the unit yourself in the event of malfunctions Only have repairs carried out by authorized service centers Please report to manufacturer if any unexpec...

Страница 30: ...unctions safely and see that it is in proper working condition before being used Please use ACCESSORIES and detachable parts specified authorized by MANUFACTURER Otherwise it may cause damage to the unit or danger to the user patients Manufacturer will make available on request circuit diagrams component parts lists etc This unit is not suitable for continuous monitoring during medical emergencies...

Страница 31: ...h two years of reliable service Please dispose of ACCESSORIES detachable parts and the ME EQUIPMENT according to the local guidelines When the device was 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 Please consult your physician about the result This device is contraindicated for a...

Страница 32: ...ermined with this device are equivalent to those obtained by a trained observer using the cuff stethoscope auscultatory method within the limits prescribed by the American National Standard manual electronic or automated sphygmomanometers The materials of the cuff have been tested and found to comply with requirements of ISO 10993 5 2009 and ISO 10993 10 2010 ...

Страница 33: ...ntended for use in measuring blood pressure and heartbeat rate with wrist circumference ranging from 13 5 cm to 21 5 cm about 5 8 It is intended for adult indoor use only FEATURES Systolic blood pressure Diastolic blood pressure Pulse rate 60 records for each user ...

Страница 34: ...the date of purchase Proof of purchase is required The warranty is void if the product has been subjected to mechanical damage or mistreatment such as immersion This warranty is in lieu of all other warranties and limits the liability of the manufacturer This warranty gives you certain legal rights and you may have other rights depending on which state the product was purchased ...

Страница 35: ...nufactured by Guangdong Transtek Medical Electronics Co Ltd Company Guangdong Transtek Medical Electronics Co Ltd Address Zone A No 105 Dongli Road Torch Development District Zhongshan 528437 Guangdong China ...

Страница 36: ...Distributed by Greater Goods LLC 125 N Main St Suite 202 St Charles MO 63301 info greatergoods com toll free 866 991 8494 greatergoods com 0605 ...

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