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ReliOn 6021RELN2, Инструкция по эксплуатации

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26

GUIDANCE AND MANUFACTURER’S DECLARATION

ReliOn

TM

 Wrist Blood Pressure Monitor

Model: 6021RELN2

Information for accompanying documents in the scope of IEC60601-1-2:2007

Important information regarding Electro Magnetic Compatibility (EMC)

With the increased number of electronic devices such as PC’s and mobile (cellular)  
telephones, medical devices in use may be susceptible to electromagnetic   
interference from other devices. Electromagnetic interference may result in incorrect    
operation of the medical device and create a potentially unsafe situation. Medical  
devices should also not interfere with other devices.

In order to regulate the requirements for EMC (Electro Magnetic Compatibility) 
with the aim to prevent unsafe product situations, the IEC60601-1-2 standard has  

 

been implemented. This standard defines the levels of immunity to electromagnetic  
interferences as well as maximum levels of electromagnetic emissions for medical devices.  
Medical devices manufactured by OMRON Healthcare conform to this 
IEC60601-1-2:2007 standard for both immunity and emissions.
Nevertheless, special precautions need to be observed:
• The use of accessories and cables other than those specified by ReliOn, with the

exception of cables sold by ReliOn as replacement parts for internal components,
may result in increased emission or decreased immunity of the device.

•  The medical devices should not be used adjacent to or stacked with other equipment.

 

In case adjacent or stacked use is necessary, the medical device should be observed  
to verify normal operation in the configuration in which it will be used.

• Refer to further guidance below regarding the EMC environment in which

the device should be used.

• The MEDICAL ELECTRICAL EQUIPMENT 6021RELN2 needs special

precautions regarding EMC and needs to be installed and put into service
according to the EMC information provided in this documentations.

• The Essential Performance of the 6021RELN2 is to measure a blood

pressure and a pulse rate and using the memory function. 

The 6021RELN2 may be interfered with by other equipment, even if that other 
equipment complies with CISPR EMISSION requirements. 

 

Содержание 6021RELN2

Страница 1: ...BP300W Wrist Blood Pressure Monitor INSTRUCTION MANUAL TM Model 6021RELN2 ESPAÑOL ENGLISH ...

Страница 2: ...el indicator 10 Battery installation 12 Setting the date and time 13 Setting the positioning indicator 14 Setting the positioning indicator 14 Applying the wrist cuff 15 Applying the cuff on the left wrist 15 Applying the cuff on the right wrist 15 Taking a measurement 16 Using the memory function 18 To view the measurement values stored in memory 18 To view the average reading 19 To delete all va...

Страница 3: ...hip between blood pressure in the wrist and blood pressure in the arm Changes in wrist blood pressure reflect changes in arm blood pressure because the arteries in the wrist and the arm are close to each other Frequently measuring the blood pressure in your wrist will provide your physician with an accurate indication of changes in your blood pressure The 6021RELN2 comes with the following compone...

Страница 4: ...e in measuring blood pressure and pulse rate in adult patient population The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with the readings To assure the correct use of the product basic safety measures should always be followed including the warnings and cautions listed in this instruction manual DO NOT adjust medication based on measurement ...

Страница 5: ...phone near the device It may result in an operational failure BATTERY USAGE GENERAL USAGE Do not insert the batteries with their polarities incorrectly aligned Use only 2 AAA Alkaline batteries with this device Do not use other types of batteries Do not use new and used batteries together Do not use the device for any purpose other than measuring blood pressure Remove the batteries if the device w...

Страница 6: ...clean safe location GENERAL PRECAUTIONS Do not submerge the device or any of the components in water Do not use the device outside the specified environment It may cause an inaccurate reading Do not drop the monitor or subject device to strong shocks or vibrations ...

Страница 7: ... to your left or right wrist 4 Measurements should be taken in a quiet place 5 Position the unit at heart level throughout the measurement 6 Remain still and do not talk during the measurement 7 Keep a record of your blood pressure and pulse readings for your physician A single measurement does not provide an accurate indication of your true blood pressure You need to take and record several readi...

Страница 8: ...ry compartment Start Stop button Wrist cuff User selection switch Memory button 6021RELN2 3200784 2A Thank you for purchasing the ReliOnTM BP300W Wrist Blood Pressure Monitor Model 6021RELN2 Date Time setting button TM TM BP300W Wrist Up button Blood Pressure Monitor Quick Start Guide KNOW YOUR UNIT ...

Страница 9: ...artbeat symbol Flashes during measurement Irregular heartbeat symbol User symbol A or B Date Time display Deflationsymbol Batterysymbol low depleted Averagereadingsymbol Diastolic blood pressure Systolic blood pressure Blood pressure level indicator High Normal Memory symbol UNIT DISPLAY ...

Страница 10: ...ement Please remove the wrist cuff and wait 2 3 minutes Re apply the wrist cuff and take another measurement AVERAGE READING SYMBOL The Average Reading Symbol is displayed when you press and hold the Memory button for more than 3 seconds The most recent average reading appears on the display screen Normal Heartbeat Irregular Heartbeat Short Long Blood pressure Pulse Pulse Blood pressure HEARTBEAT ...

Страница 11: ...terial hypertension Definitions of hypertension by office and home blood pressure levels These are from statistical values for blood pressure Systolic Blood Pressure Office Home 135 mmHg Diastolic Blood Pressure 85 mmHg 140 mmHg 90 mmHg DISPLAY SYMBOLS ...

Страница 12: ...ay turn the monitor off then replace all batteries at the same time Long life alkaline batteries are recommended Turn the unit off before replacing the batteries If the batteries are removed while the unit is still on the date and time will be reset to that of the previous use The measurement values are not deleted When the batteries are replaced you may need to reset the date and time If appears ...

Страница 13: ...rect minute press the button to confirm the date and time setting and start to set the positioning indicator NOTE Refer to the Setting the Positioning Indicator to set the positioning indicator 1 Press and hold the button until the year flashes on the display 3 Press the button to confirm the year and then the month flashes 2 Press the button to advance by one year NOTE Press and hold the button t...

Страница 14: ...mbol is displayed with the measurement values The monitor was not in the proper position symbol is displayed with the measurement values oFF Measurement starts without the positioning indicator 3 Press the Start Stop to store the setting The monitor has a built in positioning indicator that is used as an aid in determining if the monitor is at the correct height When using this positioning indicat...

Страница 15: ...essure monitor should be facing straight up 3 Position the cuff leaving a clearance of approximately 1 2 inch 1 2 cm between the cuff and the bottom of your palm 4 Wrap the wrist cuff around your wrist Do not apply over clothing NOTE Make sure the wrist cuff does not cover the protruding part of the wrist bone on the outside of the wrist APPLYING THE CUFF ON THE RIGHT WRIST When taking a measureme...

Страница 16: ...e helpful in all cases and you may wish to turn off this feature If you feel the position of the wrist according to positioning indicator s guidance does NOT match your heart height please turn off this feature NOTE Even if the device is not positioned properly after 5 seconds the monitor will still start the measurement and the wrist cuff will start to inflate The monitor is designed to store the...

Страница 17: ...pending on your individual physiological characteristics INFLATE DEFLATE COMPLETE START The monitor is in proper position The monitor is higher than the heart and needs to be lowered The monitor is lower than the heart and needs to be raised TM As the cuff inflates the monitor automatically determines your ideal inflation level This monitor detects your blood pressure and pulse rate during inflati...

Страница 18: ...itioning indicator symbol displayed with the measurement values If the memory is full the monitor will delete its oldest value The date and time are alternately displayed with the measurement values When viewing the measurement value taken without setting the date and time is displayed instead of the date and time 4 Press the Start Stop button to turn the monitor off The monitor automatically stor...

Страница 19: ... values in the memory 4 Press the Start Stop button to turn the monitor off NOTE The monitor will automatically turn off after 2 minutes TO VIEW THE AVERAGE READING 1 Select the user ID A or B 2 While display off or just completing a measurement press and hold the Memory button for more than 3 seconds NOTES If the previous measurement was taken without setting the date and time the average reading...

Страница 20: ... direct sunlight CAUTION Store the device and the components in a clean safe location CAUTION Do not subject the monitor to strong shocks such as dropping the unit on the floor Remove the batteries if the unit will not be used for three months or longer Always replace all the batteries with new ones at the same time Use the unit in a manner consistent with the instructions provided in this manual ...

Страница 21: ...o not talk during the measurement Carefully read and repeat the steps in Taking a Measurement Wrist cuff not applied correctly or movement during measurement Device error Movement during measurement Arm position changed during measurement Do not hold the wrist cuff Remain still and do not talk during measurement Refer to Taking a Measurement Remain still until the measurement is complete Refer to ...

Страница 22: ...ONS Replace both batteries with new ones at the same time Check the battery installation for proper placement of the battery polarities Blood pressure varies constantly Many factors including stress time of day how you wrap the cuff may affect your blood pressure Review the sections Before Taking a Measurement and Taking a Measurement ...

Страница 23: ...ons may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If the product does cause harmful interference to radio or television reception which can be determined by turning the product on and off the user is encouraged to try to correct the interference by one or more of the following measures Reorient or ...

Страница 24: ...use of possible loss in transit we recommend insuring the product with return receipt requested THE FOREGOING IS THE SOLE WARRANTY PROVIDED BY RELION IN CONNECTION WITH THIS PRODUCT AND RELION HEREBY DISCLAIMS ANY OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE IMPLIED WARRANTIES AND OTHER TERMS THAT MAY BE IMPOSED BY LAW IF ...

Страница 25: ...eading Automatic by electric pump Automatic rapid deflation Oscillometric method 2 AAA alkaline batteries 1 5V Approximately 300 uses with 2 new alkaline batteries 50ºF to 104ºF 10ºC to 40ºC 15 RH to 90 RH 4ºF to 140ºF 20ºC to 60ºC 10 RH to 95 RH 700 hPa to 1060 hPa Approximately 4 1 4 oz 120g not including batteries Approximately 3 2 5 l 3 4 5 w 19 20 h without the wrist cuff 87 mm 72 mm 24 mm Ap...

Страница 26: ...tured by OMRON Healthcare conform to this IEC60601 1 2 2007 standard for both immunity and emissions Nevertheless special precautions need to be observed The use of accessories and cables other than those specified by ReliOn with the exception of cables sold by ReliOn as replacement parts for internal components may result in increased emission or decreased immunity of the device The medical devic...

Страница 27: ...it is used in such environment Electromagnetic environment guidance Group 1 Class B RF emissions CISPR 11 RF emissions CISPR 11 The ReliOnTM 6021RELN2 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 ReliOnTM 6021RELN2 is suitable for use in all establishments including domestic est...

Страница 28: ...of this ReliOnTM 6021RELN2 should assure that it is used in such environment Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Floor should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 NotApplicable 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines Not App...

Страница 29: ...hould be at levels characteristic of a typical location in a typical commercial or hospital environment NotApplicable 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles Not Applicable 5 UT 95 dip in UT for 5 sec 3 A m 3 A m Note UT is the A C mains voltage prior to application of the test level Immunity test IEC 60601 Test level Compliance level Electr...

Страница 30: ...TM 6021RELN2 should assure that it is used in such environment Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 Portable and mobile RF communications equipment should be used no closer to any part of the ReliOnTM 6021RELN2 including cables than the recommended separation distance calculated from the equation appropriate to the frequency of the transmitter 3 V rms 150 kHz to 80 MHz 3 V m 80 MHz...

Страница 31: ...wing symbol cordless telephones and land mobile 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 ReliOnTM 6021RELN2 is used exceeds the applicable RF compliance level ab...

Страница 32: ...mum distance between portable and mobile RF communications equipment transmitters and the ReliOnTM 6021RELN2 as recommended below according to the maximum output power of the communications equipment 150 kHz to 80 MHz Not Applicable 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5GHz d 2 3 P For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m...

Страница 33: ...Distributed by Wal Mart Stores Inc Bentonville AR 72716 2015 Wal Mart Stores Inc Manufactured for OMRON HEALTHCARE Co Ltd 53 Kunotsubo Terado cho Muko Kyoto 617 0002 JAPAN Made in Vietnam 3200784 2A ...

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