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医療機器 AliveCor KardiaMobile AC-019のPDF 取扱説明書をオンラインで閲覧またはダウンロードできます。AliveCor KardiaMobile AC-019 19 ページ。
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Instructions for Use for KardiaMobile 6L
During this clinical study, no adverse events were observed.
Environmental Specifications
Operational Temperature:
Operational Humidity:
Storage Temperature:
Storage Humidity:
Expected Service Life
The expected service life for KardiaMobile 6L is 2 years.
Maintenance
1. No service or repair should be performed on the KardiaMobile 6L hardware other than the
maintenance listed in this section.
2. Clean the electrodes by wiping with a soft cloth dampened with water or one of the following
approved cleaners:
o Soap and water, or
o Bleach solution as recommended by the CDC (5 tablespoons bleach per gallon of
water OR 4 teaspoons bleach per quart of water)
a. To clean, spray the cleaner on a soft cloth and thoroughly wipe the device.
b. Ensure the device is sufficiently dried.
WARNING:
o DO NOT use alcohol-based or abrasive cleaners and materials as these products
could adversely affect product performance.
o DO NOT immerse device or expose device to excessive liquid.
3. Exterior Visual Inspection:
o Inspect electrodes for warping, surface damage, or corrosion
o Check for any other form of damage
4. For battery replacement, AliveCor recommends that you bring your KardiaMobile 6L
hardware to a watch repair or hearing-aid repair shop.
○ Battery Type: CR2016 Coin Cell that is IEC 60086-4 compliant
○ Ensure proper orientation of the battery with battery information and (+) terminal
facing up
+10°C to +45°C
10% to 95% (non-condensing)
0°C to +40°C
10% to 95% (non-condensing)
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