Use Instructions

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4.4 COMPLIANCE WITH STANDARDS / REGULATION AND CLASSIFICATIONS
COMPLIANT
STANDARDS
DESCRIPTION CLASSIFICATION
IEC 60601-1
 Protection type against electric shock
Class II (double isolation)
 Degree of protection against electric
shock
Type BF
 Mode of operation
Continuous operation
IEC 60601-1-2

Electromagnetic compatibility
* Refer to EMC section 11
IEC 60529

Type of protection against the access to
hazardous parts and the infiltration of
water as detailed in the current edition of
IEC
IP22
Table 9 - Mains standards & classification
4.5 EMBODY BASE AND BUTTON LABELING
EMBODY
TYPE
US / CA BASE LABELING
BUTTON
MARKINGS
(INSIDE)
EMBODY
designed for
SOLOSTAR
®
SANOFI
insulin pen
US
CA
Table 10 - EMBODY base and button labeling
NOTE:
The part number and serial number of the device can also be found on the packaging
accompanying the device.