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Omron HEM-7530T-E3, Information Sheet

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Omron HEM-7530T-E3 Information Sheet Download Page 22

 

22 

 

  PM-2020-01-07/2020 

LEGAL MANUFACTURER 

OMRON HEALTHCARE Co., Ltd 

53, Kunotsubo, Terado-cho, Muko, KYOTO, 

617-0002 Japan 

 

OMRON HEALTHCARE Co., Ltd. 

Matsusaka Factory 

1855-370, Kubo-cho, Matsusaka-shi, 

Mie, 515-8503 Japan 

 

EU-REPRESENTATIVE 

OMRON HEALTHCARE EUROPE B.V. 

Scorpius 33, 2132 LR Hoofddorp, 

THE NETHERLANDS 

 

Summary of Contents for HEM-7530T-E3

Page 1: ...ew Product Information Sheet Specifications subject to change OMRON HEALTHCARE EUROPE B V Model code Complete HEM 7530T E3 Versions Remark Date 1 Without DoC content key visual 30 09 2020 2 All information added 17 02 2021 ...

Page 2: ...2 PM 2020 01 07 2020 ...

Page 3: ...uff HEM RML31 E Afib indicator function 4 AA alkaline batteries Record measurements Storage Case Intellisense technology Instruction Manual Cuff Wrap Guide Setup Instructions Clinically validated Blood Pressure Diary Omron connect Package Amount Approximate weight Approximate dimensions wxdxh Main Unit 1 550g w o batteries 232 mm x 123 mm x 98 mm Single Package 1 1630 g 140 mm x 160 mm x 246 mm Ma...

Page 4: ...life Monitor 5 years Cuff 5 years Operating conditions 10 C to 40 C 15 to 90 RH non condensing 800 to 1060 hPa Storage Transport conditions 20 C to 60 C 10 to 90 RH non condensing Weight Monitor Approximately 550 g not including batteries Arm cuff Approximately 170 g Dimensions Monitor Approximately 232 mm w 98 mm h 123 mm l Arm cuff Approximately 145 mm 594 mm air tube 750 mm Applied part Type BF...

Page 5: ...400 2483 5 MHz Modulation GFSK Effective radiated power 20 dBm Cuff circumference applicable to the monitor 17 to 42 cm included arm cuff 22 to 42 cm Internal memory Stores up to 90 blood pressure readings ECG recording Performance characteristics ECG channel Single channel Input dynamic range 10 mV Peak to Peak Circuitry Frequency response 0 67 Hz to 40 Hz CMRR 60 dB Input Impedance 10 MΩ Output ...

Page 6: ...application of its intended purpose 1 Monitor 2 Arm cuff HEM RML31 3 4 AA batteries 4 Storage case 5 Instruction Manual 6 Setup instructions 7 Blood pressure diary The complete set of the medical device is specified in the Instruction Manual Specifications section Purpose The device is intended to measure blood pressure only electrocardiogram ECG only or blood pressure and ECG simultaneously The d...

Page 7: ...nd pulse rate in adult population The device is intended to record store and transfer single channel electrocardiogram ECG rhythms Features Particularities The Complete Automatic Upper Arm Blood Pressure Monitor and Single Lead Electrocardiogram is a clinically validated device Key features Description of operating principle The device operates on the oscillometric principle It detects blood movem...

Page 8: ...er 3 3 3 of the IM Attach the arm cuff to the monitor 7 Sit correctly and place your arm at your heart s level Remain still and don t talk 8 Open the OMRON connect app on your smartphone 9 Follow the instructions to start an ECG recording on your smartphone and place the phone on the smartphone stand of your monitor 10 Press the BP START STOP button to take a blood pressure measurement 11 Put your...

Page 9: ...Model Upper Arm Blood Pressure Monitor Cuff HEM RML31 Upper Arm Blood Pressure Monitor Cuff HEM CS24 Materials used in main device Item Parts Material Package Package Coated board E F Soft case PU polyurethane Instruction manual Wood free paper Setup instructions Wood free paper BP Diary Wood free paper Main unit Front housing ABS acrylonitrile butadiene styrene Ground housing ABS Power switch ABS...

Page 10: ...oth Nylon PVC Tube PVC polyvinyl chloride Bias Polyester Cotton Hook Fastener Polyester Nipple PVC Ring Steel Cuff HEM CS24 Air plug ABS Inner cloth Polyester PVC Outer cloth Nylon PVC Tube PVC Bias Polyester Cotton Hook Fastner Polyester Nipple PVC Ring Steel Cuff provided with the main device Title page of the Instruction Manual ...

Page 11: ...11 PM 2020 01 07 2020 Unfolded package design of main device and accessories Main device ...

Page 12: ...12 PM 2020 01 07 2020 Accessories Arm Cuff HEM RML31 Accessories Arm Cuff HEM CS24 ...

Page 13: ...N ISO 13485 2016 EN ISO 14971 2012 EN ISO 15223 1 2016 EN ISO 81060 2 2019 A1 2020 EN 300 328 V2 2 2 EN 301 489 1 V2 2 3 EN 301 489 17 V3 1 1 EN 62479 2010 EN 62368 1 2014 A11 2017 EN 50581 2012 Cleaning of the device Do not use any abrasive or volatile cleaners Use a soft dry cloth or a soft cloth moistened with mild neutral detergent to clean your monitor and the arm cuff and then wipe them with...

Page 14: ...ssively 3 Place your monitor and other components into the storage case Do not store your monitor and other components If the monitor and other components are wet In locations exposed to extreme temperatures humidity direct sunlight dust or corrosive vapors such as bleach In locations exposed to vibrations or shocks Warnings Warning indicate a potentially hazardous situation which if not avoided c...

Page 15: ...betes pregnancy pre eclampsia or renal disease NOTE that any of these conditions in addition to patient motion trembling or shivering may affect the blood pressure readings and or ECG recordings NEVER diagnose or treat yourself based on your blood pressure readings and or ECG recordings ALWAYS consult with your physician Keep components out of the reach of infants toddlers and children This produc...

Page 16: ...e may occur ONLY inflate the arm cuff when it is applied on your upper arm Remove the arm cuff if it does not start deflating during a blood pressure measurement When the monitor malfunctions it may get hot DO NOT touch the monitor if it occurs DO NOT use this monitor for any purpose other than measuring blood pressure and or recording an ECG During a blood pressure measurement and or an ECG recor...

Page 17: ...ht fitting and thick clothing from your arm while taking a blood pressure measurement Remain still and DO NOT talk while taking a blood pressure measurement Remain still while recording an ECG ONLY use the arm cuff on persons whose arm circumference is within the specified range of the cuff Ensure that this monitor has acclimated to room temperature before taking a blood pressure measurement and o...

Page 18: ...ring a blood pressure measurement and or an ECG recording the use of the monitor adjacent to or stacked with another device other than the smartphone to be used with the monitor should be avoided because it could result in improper operation In case such use is necessary the monitor and the other device should be observed to verify that they are operating normally OMRON makes no warranty for any d...

Page 19: ... an ECG It does NOT continuously monitor your heart and therefore cannot alert you if atrial fibrillation happens at any other time Result of Bradycardia or Tachycardia are designations of heart rate not a clinical diagnosis of an actual arrhythmia Consult with your physician When your fingertips are dry your ECG recording may not be successful If dry moisten your fingers with a wet towel a water ...

Page 20: ... is not in place recording an ECG may not be successful If you have lost the battery cover contact your OMRON retail outlet or distributor Disposal This product should not be disposed of with other household wastes at the end of its working life To prevent possible harm to the environment or human health from uncontrolled waste disposal please separate this product from other types of wastes and r...

Page 21: ...any extension or renewal of the warranty period Calibration and Service The accuracy of this blood pressure monitor has been carefully tested and is designed for a long service life It is generally recommended to have the unit inspected every two years to ensure correct functioning and accuracy Please consult your authorised OMRON dealer or the OMRON Customer Service at the address given on the pa...

Page 22: ...ALTHCARE Co Ltd 53 Kunotsubo Terado cho Muko KYOTO 617 0002 Japan OMRON HEALTHCARE Co Ltd Matsusaka Factory 1855 370 Kubo cho Matsusaka shi Mie 515 8503 Japan EU REPRESENTATIVE OMRON HEALTHCARE EUROPE B V Scorpius 33 2132 LR Hoofddorp THE NETHERLANDS ...

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