ActiGraph LEAP - Page 30

Regulatory Information
| Continued
Manufacturer
ActiGraph is the medical device manufacturer and is located at 70 North Baylen Street,
Suite 400. Pensacola, Florida 32502.
Operating Temperature Range
Indicates the operating temperature range to which the medical device can be safely
exposed.
40° C
0
° C
Storage Temperature Range
Indicates the operating temperature range to which the medical device can be safely
stored.
55° C
-20
° C
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
Indicates the operating humidity range to which the medical device can be safely exposed.
15
1060 hPa
Atmospheric Pressure
Indicates the operating atmospheric pressure to which the medical device can be safely
exposed.
700 hPa
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.
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ACTIGRAPH LEAP™ | E.200.6025 | RELEASED: 10/09/2023 | REV: 0
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