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SmartLab easy nG User Manual

Wrist blood pressure monitor for self-control
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Download this manual See also: User Manual
Wrist Blood Pressure Monitor for Self-Control
User Manual
Please read this manual thoroughly before
first using this device
HMM Diagnostics GmbH
Friedrichstraße 89
D-69221 Dossenheim, Germany
www.hmm.info
53

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Summary of Contents for SmartLab easy nG

  • Page 1 Wrist Blood Pressure Monitor for Self-Control User Manual Please read this manual thoroughly before first using this device HMM Diagnostics GmbH Friedrichstraße 89 D-69221 Dossenheim, Germany www.hmm.info...

  • Page 3: Table Of Contents

    Content I. Introduction Normal blood pressure fluctuation Caution Safety Information Set Content II. Your smartLAB easy ® Display & functions Specifications Note III. Setup & Operating procedures Installing and Replacing the batteries Setting Date, Time and Measuring Unit Applying the cuff...
  • Page 4 Body posture during measurement Measuring process Recall records Delete records Maintenance IV. Miscellaneous Knowledge on Blood Pressure Troubleshooting Complied European Standard List EMC Guidance Safety Notice Warranty...

  • Page 5: Introduction

    I. Introduction Thank you for using the smartLAB easy nG wrist-cuff blood pressure monitor. ® With this device you can easily control your blood-pressure values and pulse rate and store the measured data. Please read this manual thoroughly, before first using your smartLAB easy nG wrist-cuff blood pressure monitor.
  • Page 6 Considering the above information, it is recommended that you measure your blood pressure at approximately the same time each day. Please always relax a minimum of 3 to 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.

  • Page 7: Caution

    Caution • This device is intended for adult use only • This device is intended for non-invasive measuring and monitoring of arterial blood pressure. It is not intended for use on extremities other than the wrist or for functions other than obtaining a blood pressure measurement •...
  • Page 8 (300mmHg), detach the cuff from the wrist and press the START/STOP button to stop inflation • To avoid measurement errors, carefully read this manual before using the product • The equipment is not AP/APG equipment and not suitable for the use in the presence of flammable anesthetic mixture with air or oxygen or nitrous oxide •...
  • Page 9 • Please use the device under the environment which is provided in the user manual. Otherwise, the performance and lifetime of the device will be impacted and reduced • During the use, the patient will be in contact with the cuff. The materials of the cuff have been tested and found to comply with requirements of ISO 10993-5:2009 and ISO 10993-10:2010.

  • Page 10: Safety Information

    Safety information The below signs might be in the user manual, labeling or other component. They are the required for standard and using Caution: Consult accompanying Type BF applied part documents Symbol for „COMPLIES WITH MDD DISPOSAL: Do not dispose this 93/42/EEC REQUIREMENTS“...

  • Page 11: Set Content

    Set Contents 1 smartLAB easy nG Blood Pressure Monitor ® 1 User Manual 1 smartLAB Blood Pressure Passport ® 2 „AAA“ batteries...

  • Page 12: Your Smartlab ® Easy

    II. Your smartLAB easy ® Display & functions SYMBOL DESCRIPTION EXPLANATION Systolic High pressure result blood pressure Diastolic Low pressure result blood pressure Memory Hype. Pulse/minute; heartbeats/minute Memory For instructions, refer to Page Norm. Opt. Movement error Shocking will result in inaccurate values...
  • Page 13 SYMBOL DESCRIPTION EXPLANATION Deflating CUFF air is exhausting or deflating Current time Year/Month/Day, Hour/Minute Grade The grade of the blood pressure Arrhyhmia Irregular heartbeat Heartbeat Heartbeat detection during the measu- erement MEM BUTTON MEMORY SYSTOLIC LCD Display SET BUTTON DIASTOLIC GRADE START/STOP BUTTON PULSE RATE TIME...

  • Page 14: Specifications

    (Type BF applied part) BATTERY COMPARTEMENT Specifications 10. Measuring accuracy: ± 3 mmHg 1. Device: smartLAB easy nG ® 11. Heart / Pulse range: 40-199 times/min 2. Size: 68 mm x 75 mm x 31 mm 12. Pulse accuracy: within ± 5% 3.

  • Page 15: Note

    Note: Stay quite, calm and rest for 5 minutes before blood pressure measure- ment. The cuff should be placed at the same level as your heart. During measurement, neither speak nor move your body and arm. Please measure on same wrist for each measurement. For a meaningful comparison, try to measure under similar conditions.
  • Page 16 11. Patients with arrhytmia are not supposed to use this device. 12. Up to half an hour before every measurement you should not smoke, eat or do intensive physical exercise. 13. Please stay seated during measurement. 14. Please wear your smartLAB easy nG on the left wrist. ®...

  • Page 17: Setup & Operating Procedures

    III. Setup & Operating procedures Installing and Replacing the batteries • Slide off the battery cover • Install the batteries by matching the correct polarity, as shown below. Always use the correct battery type (2x AAA alkaline batteries) • Replace the cover Replace the batteries when: - The shows...
  • Page 18 Remove batteries if the device is not likely to be used for some time Do not dispose the batteries in fire. Batteries may explode or leak. The monitor, the batteries and the cuff, must be disposed according to local regulations at the end of their usage.

  • Page 19: Setting Date, Time And Measuring Unit

    Setting Date, time and measurement unit It is important to set the clock before using your wrist blood pressure monitor, so that a time stamp can be assigned to each record that is stored in the me- mory. You need to reset the device after a battery exchange. 1.When the monitor is OFF, press the SET button to enter the clock mode, then press and hold the...
  • Page 20 3.When you get the right year, press “SET” to confirm and turn to next step 4.Repeat the 2 and 3 to set the [MONTH] and [DAY]...
  • Page 21 5.Select the 24 hours time form or the 12 hours time form. Repeat step 2 and 3 to confirm [HOUR] and [MINUTE]...
  • Page 22 6.Repeat the 2 and 3 to set the [UNIT]. 7.After confirming the meausrement unit, the LCD will display all the settings you have done one by one and the monitor will shut off.

  • Page 23: Applying The Cuff

    Applying the cuff Remove all accessories (watch, bracelet, etc.) from your wrist. If your physician has diagnosed you with poor circulation in your wrist, use the other one. Roll or push up your sleeve to expose the skin. Apply the cuff to your wrist with your palm facing up. Position the edge of the cuff about 1-1.5cm.

  • Page 24: Body Posture During Measurement

    Note: • Measure on the same wrist each time. • Do not move your arm, body, or the monitor and do not move the cuff during measurement. • Stay quiet, calm for 5 minutes before blood pressure measurement. Body posture during measurement Sitting Measurement –...

  • Page 25: Measuring Process

    Measuring process 1. When the monitor is off, press the START/STOP to turn on the monitor, and it will finish the whole measurement. LCD display lights up and all symbols show Adjust the zero. While inflating and measuring following will show on display...
  • Page 26 Results are displayed after measurement and then saved 2.Press the START/STOP to turn off the power, otherwise it will turn off within 1 minute. Note: You should wait 3-5 minutes after each measurement to let the blood circulation in your arm recover. It is unusual to obtain the same values with each measurment.

  • Page 27: Recall Records

    Recall records 1. When the monitor is off, press the “MEM” to show the first record 2.Press the “MEM” or “SET” to get the DOWN record you want Date and time The corresponding The corresponding will display alternately date is 5th January time is 10:38...

  • Page 28: Delete Records

    Note: The most recent record (1) is shown first. Each new measurement is assi- gned to the first (1) record. All other records are pushed back one digit (e.g. 2 becomes 3, and so on), and the last record (60) is dropped from the list. Delete Records If you want to delet all recorded measurements please follow these steps: 1. When you are in the memory mode, hold pressing “MEM” for 3 seconds, the flash display will show „DEL ALL“...
  • Page 29 3.If you don’t want to delete the records, press START/STOP to escape 4.If there is no record the right display will show Tips for measurement Incorrect values while measurement can be caused by following circumstances: • Immediate measurement after eating or drinking • Immediate measurement after tea, coffee, smoking •...

  • Page 30: Maintenance

    Please also pay attention to following steps when measuring your blood pres- sure at home: • The cuff is tied properly • The cuff should not be to tight or loose • The cuff is tied on the wrist Maintenance •...

  • Page 31: Miscellaneous

    IV. Miscellaneous Knowledge on Blood Pressure Your heart is just like a pump which causes the blood to circulate through all vessels. As a result, the blood pressure is the pressure on the wall of the blood vessel pressed by blood. The output of blood from the heart when it is a systole is called systolic pressure.
  • Page 32 compare to normal BP Reason systolic pressure diastolic pressure high high • • Drinking, smoking • • Excitement or sporting • • seeing a doctor, desire to urinate • • change of tem- high perature • • • • After bathing, deep breathing or yawning •...
  • Page 33 The blood pressure is influenced by a variety of different factors, such as bodily circumstances or a wrong operation of the monitor. Some people even get ner- vous when seeing a doctor and that will make their blood pressure rise. Single measurements can not indicate the whole blood level, so you need not to be anxious for isolated higher or lower blood pressure results.
  • Page 34 Male Female Gender systolic diastolic systolic diastolic 11-15 16-20 21-25 26-30 31-35 36-40 41-45 46-50 51-55 56-60 61-65...

  • Page 35: Assessing High Blood Pressure For Adults

    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.
  • Page 36 Hypertension: Various cardiovascular or kidney diseases can cause hypertension. Long- term hypertension can also cause pathological changes in heart, brain and kidney. These changes can lead to hypertension complications which are often diagnosed or treated too late. Low Blood Pressure: There are two kinds of minimum pressure: •...

  • Page 37: Troubleshooting

    Troubleshooting PROBLEM SYMPTOM CAUSE REMEDY No power Display is dim or Batteries are low Replace with new will not light up batteries Batteries are inser- Insert batteries ted incorrectly correctly Show on Batteries are low Replace with new Low batteries display batteries E 1 shows...
  • Page 38 PROBLEM SYMPTOM CAUSE REMEDY E 3 shows The pressure of the Relax for a moment cuff is to high and then measure again E 10 or E 11 shows The monitor detec- Movement can ted motion while effect the measu- measuring rement.
  • Page 39 PROBLEM SYMPTOM CAUSE REMEDY EExx, shows on the A calibration error Repeat the mea- display occurred surement. If the problem persists, contact your Error message retailer for further assistance. Refer to warranty for con- tact information.

  • Page 40: Complied European Standards List

    Complied European Standards List Risk Management EN/ISO 14971:2007 Labeling EN 15223-1:2012 User Manual EN 1041:2008 Generel Requirements for Safety EN 60601-1:2006/AC2010 EN 60601-1-11:2010 Non-invasive Sphygmomanometers EN 1060-1:1995+A2:2009 General Requirements EN 1060-3:1997+A2:2009 EN 1060-4:2004 Electromagnetic Compatibility EN 60601-1-2:2007/AC:2010 Software Lifetime EN 62304:2006/AC:2008 Usability EN 60601-1-6:2010 EN 62366:2008...

  • Page 41: Emc Guidance

    EMC Guidance Table 1 Guidance and manufacturer‘s declaration - Electromagnetic Emissions - for all ME Equipment and ME Systems Guidance and manufacturer‘s declaration - electromagnetic emissions The device is intended for use in the electromagnetic enviroment specified below. The customer or the user of the device should assure that it is used in such an environ- ment.
  • Page 42 Harmonic emissions IEC applicable 61000-3-2 Voltage fluctu- ations/ flicker applicable emissions IEC 61000-3-3...
  • Page 43 Table 2 Guidance and Manufacturer declaration - electromagnetic immunity - for all ME Equipment and ME System Guidance and manufacturer’s declaration – electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment IMMUNITY test IEC 60601 test level Compliance Electromagnetic level...
  • Page 44 Electrical fast ±2 kV for Not applicable Mains power quality transient/burst power supply lines should be that of a typical IEC 61000-4-4 ±1 kV for commercial or hospital input/output lines environment. Surge IEC ±1 kV line(s) Not applicable Mains power quality 61000-4-5 to line(s) should be that of a typical...
  • Page 45 Power frequency 3A/m 3A/m Power frequency magnetic (50/60Hz) fields should be at levels magnetic field characteristic of a typical IEC 61000-4-8 location in a typical commercial or hospital environment. NOTE UT is the a.c. mains voltage prior to application of the test level.
  • Page 46 Table 4 Guidance and Manufacturer‘s declaration - electromagnetic Immunity - for ME Equipment and ME Systems that are not Life-Supporting Guidance and manufacturer’s declaration – electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. IMMUNITY IEC 60601 TEST Compliance...
  • Page 47 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 metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range.
  • Page 48 Table 6 Recommended separation distance between portable and mobile RF communnications equipment and the ME Equipment or ME System - for ME Equipment and ME Systems that are not Life-Supporting Recommended separation distances between portable and mobile RF communications equipment and the device. The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.

  • Page 49: Safety Notice

    Not applicable 3.690 7.378 Not applicable 11.67 23.33 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated 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.
  • Page 50 while encouraging for reuse, recycling and other forms of reprocessing to reduce waste. The WEEE logo on the product and the packaging indicates that it is not allowed to dis- pose of the product in the ordinary household waste. It is your responsibility to deliver all the disused electrical and electronic equipment to the respective collection points.

  • Page 51: Warranty

    Warranty HMM Diagnostics GmbH products need to fulfill high quality requirements. Because of this reason, HMM Diagnostics GmbH gives a 2-year warranty by purchasing this smartLAB product. You can even extend the warranty from 3 ® to 5 years without extra pay when you register your product. Please register online under following website: www.hmm.info/en/registration.
  • Page 52 Hersteller/Manufacturer: HMM Diagnostics GmbH Friedrichstr. 89 D-69221 Dossenheim, Germany E-mail: info@hmm.info www.hmm.info Weitere Informationen zu den smartLAB Produkten / ® More information on our smartLAB products: ® www.smartlab.org...

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