Care, Maintenance And Storage; Reference To Standards; Product Specifications - Medel Elite Manual Del Usuario

EN
MEDEL ELITE.

7. CARE, MAINTENANCE AND STORAGE

1. For cleaning only use a soft, lightly moistened cloth.
2. Do not use petroleum spirits, thinners or similar solvents.
3. Do not wash the cuff.
4. Take care to ensure the cuff is not damaged by sharp or pointed objects such as
scissors, knives, etc.
5. Take the batteries out if the device is not used for a long period.
6. In case the device becomes malfunction due to the influence of strong electroma-
gnetic fields, power off the device and repeat the procedure again.
7. Disposal of the device (and used batteries) should be carried out according to the
national regulations for the disposal of electronic products.
8. Cleaning: Dust environment may affect the performance of the unit. Please use the
soft cloth to remove the dirt of the device and cuff before and after use. To obtain
the best performance, please follow below instructions:
• Put in a dry place and avoid the sunshine;
• Avoid immersing it in the water. Clean it with a dry cloth in case.
• Avoid shaking and collision.
• Avoid dusty environment and unstable temperature surrounding.
• Protect if from:
- water and moisture
- extremes temperature, humidity and altitude
- impact and dropping
- contamination and dust
- direct sunlight

8. REFERENCE TO STANDARDS

Device standard: Device corresponds to the requirements of the European standard for
non-invasive blood-pressure monitor.
• EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1: Requirements
and test methods for non-automated measurement type
• EN 1060-3:1997+A2:2009 Non-invasive blood pressure Part 3: Supplementary
requirements for electromechanical blood pressure measuring system
• EN 1060-4: Non invasive shygmomanometers - Test procedures to determine the
overall system accuracy of automated non-invasive sphygmomanometrs.
• IEC 60601-1:2005+A1:2012 Medical electrical equipment - Part 1: General requi-
rements for basic safety and essential performance.
• NIBP - Requirements
• IEC 80601-2-30:2009+A1:2013 Medical electrical equipment - Part 2-30: Par-
ticular requirements for the basic safety and essential performance of automated
non-invasive sphygmomanometers
• IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General require-
ments for basic safety and essential performance - Collateral standard: Requiremen-
ts for medical electrical equipment and medical electrical systems used in the home
healthcare environment
• IEC 60601-1-8:2006+A1:2012 Medical electrical equipment - Part 1-8: General
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requirements for basic safety and essential performance - Collateral Standard:
General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical system.
• IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requiremen-
ts for basic safety and essential performance - Collateral standard : Electromagnetic
compatibility - Requirements and tests
In conformity with the European Medical Device Directive 93/42/EEC
Separate collection for waste electrical and electronic equipment.
Applicable to European Union countries and countries with separate collection
systems) This symbol on the product or its literature indicates that the product
complies with the Electrical and electronic equipment and should not be disposed of
as household waste. The user is responsible for the transfer of the equipment at end of
life with the appropriate collection facilities, subject to the penalties provided for by
current legislation on waste. For more detailed information collection systems avail-
able contact your local waste disposal service.

9. PRODUCT SPECIFICATIONS

Display : LCD large digital backlight display
Technology: Oscillometric method
Classification : Internally powered equipment, with type BF applied part
Rated cuff Pressure : 0 to 300 mmHg
Measurement Pressure:
Measurement
SYS: 60 mmHg to 230 mmHg
range:
DIA: 40 mmHg to 130 mmHg
Heart rate : 40 to 199 times/minute
Pressure : +/- 3 mmHg
Accuracy :
Heart rate : +/- 5%
Memory : Storing 60 memories (Systolic / Diastolic pressure, Heart beat)
Power supply: 4 AA 1.5V (batteries)
Battery life: For approx. 540 measurements, depending on levels of blood pres-
sure and pump pressure
Accessories: Universal cuff circum. 22 - 42 cm
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