G-Lab MD2520 Instruction Manual Download Page 2

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INTRODUCTION

Thank you for purchasing the G.LAB MD2520/MD2540/MD2580

Blood Pressure Monitor.

The device is easy-to-use and good for home users and healthcare

professionals. It applies non-invasive oscillometric method which

can measure your blood pressure and pulse rate quickly and easily,

and it saves the data automatically to let you review the average and

measured data at any time.

Indication for use

This device is for use by medical professional or home users. It is

intended to measure the systolic and diastolic blood pressure of an

adult individual by using a non-invasive technique, in which an

inflatable cuff is wrapped around the upper arm.

COMPLIANCE

This device conforms to European Medical Device Directive

93/42/EEC.

This device complies with:

• EN ISO 81060 standard relating to non-invasive sphygmomanom-

eters

Part 1: Requirements and test methods for non-automated

measurement types and EN 1060 standard relating to non-invasive

sphygmomanometers.

Part 3: Supplementary requirements for electro-mechanical blood

pressure measuring systems.

• EN 60601 standard relating to medical electrical equipment

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

performance and essential performance – Collateral standard:

Electromagnetic compatibility – Requirements and tests.

• EN 1060-4:2004 standard relating to non-invasive sphygmoma-

nometers

Part 4: Test procedures to determine the overall system accuracy

of automated non-invasive sphygmomanometers.

• ISO 81060-2:2013 standard relating to non-Invasive sphygmoma-

nometers

Part 2: Clinical validation of automated measurement type.

• IEC 80601-2-30:2009+A1:2013 standard relating to medical

electrical equipment

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

essential performance of automated type non-invasive

sphygmomanometers.

Summary of Contents for MD2520

Page 1: ...ONAL AC ADAPTER 8 SETTING DATE AND TIME 9 BEFORE TAKING A MEASUREMENT 10 APPLYING ARM CUFF 10 PERFORMING BLOOD PRESSURE MEASUREMENT 11 RECALL AVERAGE AND PREVIOUS MEASUREMENT DATA 12 DELETE MEASUREMENT DATA 12 PRESSURE BAR INDICATOR 13 WHO CLASSIFICATION INDICATOR 13 ABOUT IRREGULAR HEARTBEAT 14 ABOUT BLOOD PRESSURE 14 TROUBLESHOOTING 15 TECHNICAL SPECIFICATION 16 APPENDIX I 17 18 APPENDIX II 19 2...

Page 2: ...invasive sphygmomanom eters Part 1 Requirements and test methods for non automated measurement types and EN 1060 standard relating to non invasive sphygmomanometers Part 3 Supplementary requirements for electro mechanical blood pressure measuring systems EN 60601 standard relating to medical electrical equipment Part 1 2 General requirements for basic safety and essential performance and essential...

Page 3: ...place cardiac examination The WHO Blood Pressure Classification chart is a guide for reference and is not intended to replace medical diagnosis Use the device only as intended Do not use the device for any other purpose Do not apply the device on an arm with an unhealed wound or under medical treatment Do not take measurements more than necessary High measurement repetition rates may cause pain nu...

Page 4: ...may shorten the life of the part Dispose used equipment parts batteries and optional accessories according to applicable local regulations Unlawful disposal may cause environmental pollution IMPORTANT NOTES If you have any of the following medical conditions you may get an inaccurate reading with the device Please consult your physician before using the device Patients in shock Cardiac arrhythmias...

Page 5: ...into any openings or hoses This may damage the unit Do not press the buttons with excessive force or with pointed objects IMPORTANT NOTES IMPORTANT NOTES Do not wrap the cuff around body parts other than your upper left arm Misuse represents a risk to your health Packaging materials are a deadly hazard for children and can cause suffocation Remove all packaging materials immediately and keep them ...

Page 6: ...Air Jack Battery Cover DC Jack Clock Key User 2 Key User 1 Key Display Main Unit Arm Cuff 5 DEVICE DESCRIPTION Air Plug Air Tube ...

Page 7: ...zing Releasing Air Average Data Pressure Bar Memory Record Number and Data Battery Indicator Pulse Rate Diastolic Pressure Systolic Pressure Irregular Heartbeat Indicator Heart Mark Severe Hypertension Moderate Hypertension Mild Hypertension High Normal Normal Optimal ...

Page 8: ...ause a choking hazard to children Store the batteries out of the reach of children In case battery fluid leaks do not touch the battery fluid Avoid skin contact e g put on protective gloves and clean the battery compartment with dry cloth Remove the batteries from the battery compartment if the device will not be used for a long period Use only 1 5V alkaline batteries Do not use other types of bat...

Page 9: ...en the AC adapter is in use the main unit does not draw power from batteries 8 USE THE OPTIONAL AC ADAPTER The AC Adapter 6VDC 600mA is an optional accessory and is sold separately A Connecting the AC adapter to the device 1 Insert the AC adapter output plug into the DC jack on the right side of the main unit 2 Plug the AC adapter into an AC outlet 3 The device will turn on and enter date and time...

Page 10: ...key to confirm and then HOUR will start to blink 8 Press or key to set the current Hour 9 Press key to confirm and then MINUTE will start to blink 10 Press or key to set the current Minute 11 Press key to confirm Date and time setting is completed 12 The device returns to Clock mode Date and time appear on the display B When device is in OFF status 1 Press key to turn on the device in Clock displa...

Page 11: ...ally tired or exhausted Remain still and do not talk during the measurement Position the cuff at heart level throughout the measurement Relax and sit comfortably on a chair Lay your feet flat on the floor Do not cross your feet Keep your back straight APPLYING ARM CUFF 1 Bare your left upper arm Make sure that the blood circulation in your arm in not constricted by any clothing that is too tight 2...

Page 12: ...will deflate 5 The monitor automatically determines your ideal inflation level and will stop inflation automatically When inflation completes deflation will start automatically The device is measuring the blood pressure and the pulse rate while the cuff is deflating Releasing air indicator the corresponding pressure bar indicators and the current cuff pressure appear on the display As soon as a pu...

Page 13: ...e same user key to view previous measurement data Corresponding memory record number and time of measurement appear on the display 3 Press the same user key again to display the measurement data from most recent data to older data in order 4 Press and hold the same user key for about 3 seconds to turn off the device DELETE MEASUREMENT DATA 1 While you are viewing the average or previous measuremen...

Page 14: ... a snapshot of your blood pressure classification based on your measurements This will help you to understand what your blood pressure values mean Each segment of the bar indicator corresponds to the WHO blood pressure classification Pressurizing Releasing Air Inflation in progress Inflation complete Measurement in progress mmHg 110 105 100 95 90 85 80 Diastolic blood pressure 120 130 140 150 160 ...

Page 15: ...inst the walls of the arteries Systolic pressure occurs when the heart contracts Diastolic pressure occurs when the heart expands Blood pressure is measured in millimeters of mercury mmHg One s natural blood pressure is represented by the fundamental pressure which is measured first thing in the morning while one is still at rest and before eating What Is Hypertension And How Is It Controlled Hype...

Page 16: ...t ERROR code 3 E3 appears No pressure is detected The cuff may not fasten properly or too loose Reapply the cuff and fasten the cuff correctly ERROR code 5 E5 appears The cuff is over inflated Blood pressure over 300 mmHg It is recommended to consult your physician immediately ERROR code 6 E6 appears Low battery level Replace all used batteries with new batteries The monitor keeps re inflating Sys...

Page 17: ... 3 x 1 8 99 x 160 x 45mm Cuff Size Arm Circumference Range Standard 9 14 22cm 36cm Large 14 17 35cm 44cm Full Range 9 17 22cm 44cm Operating Temperature 41 F to 104 F 5 C to 40 C Operating Humidity 15 to 93 RH Storage Temperature 13 F to 158 F 25 C to 70 C Storage Humidity up to 93 RH Operation storage and transport atmospheric pressure 700hPa to 1060hPa Power Source 4 x 1 5V AA alkaline batteries...

Page 18: ...t The Sphygmomanometer MD2520 MD2540 MD2580 uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The Sphygmomanometer MD2520 MD2540 MD2580 is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network ...

Page 19: ... intended for use in the electromagnetic environment specified below The customer of the user of Sphygmomanometer MD2520 MD2540 MD2580 should assure that it is used in such an environment Power frequency 50Hz 60Hz magnetic field IEC 61000 4 8 18 ...

Page 20: ...ter MD2520 MD2540 MD2580 should assure that it is used in such an environment Portable and mobile RF communications equipment should be used no closer to any part of the Sphygmomanometer MD2520 MD2540 MD2580 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter 19 APPENDIX II ...

Page 21: ...tic site survey should be considered If the measured field strength in the location in which the Sphygmomanometer MD2520 MD2540 MD2580 is used exceeds the applicable RF compliance level above the Sphygmomanometer MD2520 MD2540 MD2580 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Sphygmoma...

Page 22: ...nment in which radiated RF disturbances are controlled The customer or the user of the Sphygmomanometer MD2520 MD2540 MD2580 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Sphygmomanometer MD2520 MD2540 MD2580 as recommended below according to the maximum output power of the communications...

Page 23: ... 22 ...

Page 24: ...rning 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 technician for help WARNIN...

Page 25: ...tability to five 5 years from the original date of purchase at retail This warranty extends only to the original retail purchaser and is not transferable G LAB s sole liability from this warranty is limited to replacement of defective product Under no circumstances shall G LAB be held liable for death or injuries to persons damage to property loss of use or any other special incidental contingent ...

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