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IFU_MAL_US_V1.13_January 2021
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If the device is dropped or receives an impact, its water and dust resistance may be
impaired.
11. TECHNICAL SPECIFICATIONS
11.1 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
According to EN 55011 /
CISPR 11 the device is
classified as a group 1 device
with class B emission limits.
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 for the base
Table 9 - Compliance with standards / regulations and classifications
11.2 MALLYA BASE LABELLING
MALLYA SENSOR TYPE
LABELING
Mallya base for insulin pen:
FLEXPEN
®
NOVO NORDISK
Mallya base for insulin pen:
KWIKPEN
®
ELI LILLY
Mallya base for insulin pen:
SOLOSTAR
®
SANOFI
Table 10 - Base labelling