User's Manual

Page 10 of 38
conditions defined in this standard. Other external factors, such as varying back pressure, temperature,
head height, set usage, fluid restrictions, solution viscosity, or combinations of these factors may result
in deviations from the performance data presented
 IEC 60601-1-8 - Medical electrical equipment -- Part 1-8: General requirements for basic safety and
essential performance - Collateral standard: General requirements, tests and guidance for alarm systems
in medical electrical equipment and medical electrical systems
 IEC 60601-1-11 - Medical electrical equipment -- Part 1-11: General requirements for basic safety and
essential performance – Collateral Standard: Requirements for medical electrical equipment and
medical electrical systems used in the home healthcare environment
 ISO 11608-1 - Needle-based injection systems for medical use — Requirements and test methods — Part
1: Needle-based injection systems
 FCC: The Federal Communications Commission (FCC) regulates interstate and international
communications by radio, television, wire, satellite and cable. The Wearable Infusion Pump complies
with Part 15 of the FCC Rules.
 Classification according to IEC 60601-1:
o Internally powered
o Type CF
o Continuous operation
o Not suitable for use in the presence of flammable aesthetic mixture with air or with oxygen or
nitrous oxide
 Classification according to IEC 60601-2-24:
o Type 1 Ambulatory pump
1.4.3 FCC and IC Information for EMC and Radio Frequency
FCC ID: 2AR6L-SORRELWIP
IC: 24632-SORRELWIP
CAN ICES-3 (B) /NMB-3 (B) HVIN 04 FVIN 1.2.0
Sorrel Medical Ltd. has not approved any changes or modifications to this device by the user. Any
changes or modifications not expressly approved by Sorrel Medical Ltd. could void the user’s authority to
operate the equipment.