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Omron M6 Comfort Information Sheet
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Omron M6 Comfort Information Sheet

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New Product Information Sheet
Specifications subject to change
© OMRON HEALTHCARE EUROPE B.V.
Model (code):
M6 Comfort (HEM-7360-E)
X6 Comfort (HEM-7360-EO)
Versions
Remark
Date
1
Logistics and Harmonized
31.07.2019
Standards info not
complete;
2
Full NPIS
Expected date – end
of August
OMRON HEALTHCARE EUROPE B.V.
Scorpius 33 2132 LR Hoofddorp The Netherlands
P.O. Box 2050 2130 GL Hoofddorp The Netherlands
Phone: +31 (0)23 55 44 700 fax +31 (0)23 55 44 701
www.omron.healthcare.com
BANKERS BANK OF TOKYO-MITUSBISHI (HOLLAND) N.V.
ACC. NR. 063.56.15.320 IBAN NL95BOTK0635615320
PM-1826-01-07/2019
SWIFT BOTKNL2X
CHAMBER OF COMMERCE NR. 342.10306
BTW/VAT NR. NL8132.86.281.B01

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Summary of Contents for Omron M6 Comfort

  • Page 1 New Product Information Sheet Specifications subject to change © OMRON HEALTHCARE EUROPE B.V. Model (code): M6 Comfort (HEM-7360-E) X6 Comfort (HEM-7360-EO) Versions Remark Date Logistics and Harmonized 31.07.2019 Standards info not complete; Full NPIS Expected date – end of August OMRON HEALTHCARE EUROPE B.V.
  • Page 2 PM-1826-01-07/2019...
  • Page 3 Xxxg 223 mm 633 mm x 340 mm x Master Carton Xxxkg 263 mm EAN code M6 Comfort : 401567211174 5 , X6 Comfort : 401567211215 5 Storage & transport Temperature: - 20 to +60°C Humidity: 10% to 90% PM-1826-01-07/2019...
  • Page 4 Technical data Product description Automatic Upper Arm Blood Pressure Monitor Product Category Electronic Sphygmomanometers Model (code) M6 Comfort (HEM-7360-E) X6 Comfort (HEM-7360-EO) Measurement method Oscillometric method Display LCD digital display Cuff Pressure range 0 to 299 mmHg Pulse measurement 40 - 180 beats/min...
  • Page 5 Operating conditions +10 to +40 °C / 15 to 90% RH (non- condensing)/ 800 to 1060 hPA Storage / Transport -20 to +60 °C / 10 to 90% RH (non- conditions condensing) Protection against Internally powered ME equipment (when using electric shock only batteries) Class II ME equipment (optional AC adapter)

  • Page 6: Application Field

    Afib can only be confirmed by an Electrocardiogram (ECG). If the Afib symbol appears, consult with your physician Packaging content The manufacturer produces M6 Comfort / X6 Comfort with the applicable accessories included, necessary for the application of its intended purpose.
  • Page 7 This device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. Features (Particularities) The M6 Comfort Automatic Upper Arm Blood Pressure Monitor is a clinically validated device. Key features: • Afib indicator function •...
  • Page 8 9. After selecting your used ID, you can use the memory functions (readings stored, average of the latest 2-3 readings, clear memory). Please, review Instruction Manual 1 and 2 for the full details on the application of this product. Materials used in main device Parts Name Material Housing...
  • Page 9 Title page of Instruction Manuals IM1: IM2: PM-1826-01-07/2019...
  • Page 10 Unfolded package design of main device and accessories Main device: PM-1826-01-07/2019...
  • Page 11 Accessories: Arm Cuff (HEM-FL31) AC Adapter (HHP-CM01) PM-1826-01-07/2019...
  • Page 12 AC Adapter (HHP-BFH01) Other optional parts: Protective LCD Cover (HEM-CACO-734) List of Harmonized EN Standards Applicable Directives: Medical Device Directive (MDD) 93/42/EEC Full list of Harmonized standards will be included in the next revision of the document. Cleaning of the device •...

  • Page 13: Maintenance

    • Use a soft dry cloth or a soft cloth moistened with mild (neutral) detergent to clean your monitor and arm cuff, and then wipe them with a dry cloth. • Do not wash or immerse your monitor and arm cuff or other components in water.
  • Page 14 • DO NOT adjust medication based on readings from this blood pressure monitor. Take medication as prescribed by your physician. ONLY a physician is qualified to diagnose and treat high blood pressure. • DO NOT use this monitor on an injured arm or an arm under medical treatment.
  • Page 15 Battery Handling and Usage • Keep batteries out of the reach of infants, toddlers and children. Cautions (Cautions indicate a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or damage to the equipment or other property.) •...
  • Page 16 • Ensure that this monitor has acclimated to room temperature before taking a measurement. Taking a measurement after an extreme temperature change could lead to an inaccurate reading. OMRON recommends waiting for approximately 2 hours for the monitor to warm...
  • Page 17 • ONLY use the approved arm cuff for this monitor. Use of other arm cuffs may result in incorrect readings. • Inflating to a higher pressure than necessary may result in bruising of the arm here the cuff is applied. NOTE: refer to “If your systolic pressure is more than 210 mmHg”...
  • Page 18 Please use the Blood Pressure Diary to keep records of several readings over a certain period of time. To download PDF files of the diary, visit www.omron-healthcare.com. Disposal Household users should contact either the retailer where they purchased this product, or their local government office, for details of where and how they can return this item for environmentally safe recycling.
  • Page 19 5 years Repair During the period of warranty OMRON will, without charge for labour or parts, repair or replace the defect product or any defective parts. Repair or replacement under the warranty does not give rise to any extension or renewal of the warranty period.
  • Page 20 EU-REPRESENTATIVE OMRON HEALTHCARE EUROPE B.V. Scorpius 33, 2132 LR Hoofddorp, THE NETHERLANDS PM-1826-01-07/2019...

This manual is also suitable for:

X6 comfortHem-7360-eHem-7360-eo