List of Harmonized EN Standards Directives General applicable directives: Medical Device Directive (MDD) 93/42/EEC Standards: EN 980: 2008 EN 1041: 2008 EN 1060-1:1995+A2:2009 EN 1060-3:1997+A2:2009 EN ISO 10993-1: 2009 EN ISO 10993-5: 2009 EN ISO 10993-10: 2009 EN ISO 14971: 2009 EN 60601-1:1990+A1:1993+A2:1995 EN 60601-1-2: 2007 EN 60601-1-4:1996+A1:1999...
Intended Use Medical Purpose This product is intended for use to measure and/or monitor patients to record their blood pressure levels. Intended User • Legally certified medical experts, such as doctor, nurse and therapist, or healthcare personnel or patient under the guidance of qualified medical experts.
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Particularities M6W (HEM-7213-E(V)) is an automatic blood pressure monitor that has the unique selling points as noted: Two users with memory 100 memories with date and time for each user (A and B) Optimal speed and pressure for gentle inflation/deflation ...
Package Design Packaging Information: Carton Approx. Weight Approx. Dimensions (W) x (D) x (H) Single unit 340 g 123 x 141 x 85 Master carton 9.5 Kg 587 x 292 x 216 GP-HEM-7200-E2(V)-03-10/2011 Part 5...
Part 1: General Requirements and Part 3: Supplementary requirements for electromechanical blood pressure measuring systems. • This OMRON product is produced under the strict quality system of OMRON HEALTHCARE Co. Ltd., Japan. The Core component for OMRON blood pressure monitors, which is the Pressure Sensor, is produced in Japan.
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Comparison Table New model Predecessor Model M3W (HEM 7213-E(V)) M6 (HEM 7211-E / E8) Measurement Oscillometric Same as new model Method Measurement Pressure: 0mmHg to 299mmHg Same as new model range Pulse: 40 to 180/min. 100 measurements 90 measurements Memory with date and time for each user (A and B) with date and time for one user Pressure: ±3mmHg...
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List of Materials (Main unit) Item Material Grade Acrylonitrile butadiene UMG EX-120 or Front Housing styrene Techno polymer 130 Acrylonitrile butadiene UMG EX-120 or Ground Housing styrene Techno polymer 130 Acrylonitrile butadiene UMG EX-120 or Battery Cover styrene Techno polymer 130 Acrylonitrile butadiene UMG EX-120 or Start Button...
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List of Materials (Medium Cuff) Item Material Grade Bias Tape Polyester #EX3001 Cloth covering Polyester #P165T Air Tube DIC G-261 Hook and Loop Hook: PVC Hook: 1991# fastener Loop: Nylon Loop: Pantone Cool Gray 7C Metal Ring SWRM Air plugs to device Air plug to cuff DIC G-263 GP-HEM-7213-E(V)-01-11/2011...
• Do not use petrol, thinners or similar solvents to clean the arm cuff. • Do not carry out repairs of any kind yourself. If a defect occurs, consult your OMRON retail outlet or distributor as mentioned on the packaging.
Optional Accessories Cuffs Wide Range Arm Cuff Medium Arm Cuff Large Arm Cuff Arm Circumference Arm Circumference Arm Circumference 22-42 cm 22-32 cm 32-42cm Small Arm Cuff Arm Circumference 17-22 cm AC Adapter S Adapter S – 9515336-9 GP-HEM-7213-E(V)-01-11/2011 Part 11...
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