ActiGraph LEAP Instructions For Use Manual page 30

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Regulatory Information
|
Continued
Manufacturer
ActiGraph is the medical device manufacturer and is located at 70 North Baylen Street,
Suite 400. Pensacola, Florida 32502.
40
C
Operating Temperature Range
°
0
C
Indicates the operating temperature range to which the medical device can be safely
°
exposed.
55
C
Storage Temperature Range
°
-20
C
Indicates the operating temperature range to which the medical device can be safely
°
stored.
Recycle: Electronic Equipment
Indicates the medical device should not be disposed of in the trash. Contact ActiGraph
Customer Service regarding the disposal of these products.
Lithium Ion (EU)
Indicates the lithium ion battery within the device should not be disposed of in the trash.
Contact ActiGraph Customer Service regarding the disposal of these batteries.
90%
Humidity Range
15
Indicates the operating humidity range to which the medical device can be safely exposed.
1060 hPa
Atmospheric Pressure
700 hPa
Indicates the operating atmospheric pressure to which the medical device can be safely
exposed.
Type BF Applied Part
The LEAP is compliant with IEC (International Electrotechnical Commission) standards for
"Type BF Applied Part" - meaning it complies with requirements for user protection against
electrical shock. The housing of the device is the only part that is to come into contact with
the end user and is made out of copolymer. If you have any allergic reactions to copolymer
materials, please consult your doctor before using an ActiGraph device.
30
ACTIGRAPH LEAP™ | E.200.6025 | RELEASED: 10/09/2023 | REV: 0
THEACTIGRAPH.COM

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