Page 7 / 41 IFU_MAL_EN_V6
4.4 COMPLIANCE WITH STANDARDS / REGULATION AND CLASSIFICATIONS
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
• Electromagnetic compatibility
* Refer to EMC section 12
IEC 60529
Type of protection against the access to
hazardous parts and the infiltration of
water as detailed in the current edition of
IP22
Table 9 - Mains standards & classification
4.5 MALLYA BASE LABELING
MALLYA type BASE LABELING
MARKINGS
Mallya designed
for FLEXPEN
®
NOVO
NORDISK insulin
pen
Mallya designed
for KWIKPEN
®
ELI LILLY insulin
pen
Mallya designed
for SOLOSTAR
®
SANOFI insulin
pen
Table 10 - Mallya base and button labeling
NOTE:
The part number and serial number of the device can also be found on the packaging
accompanying the device.
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