7 Amico Accessories Inc.
Conditions of Acceptability
CAUTION: When installed in an end-product, consideration must be given to the following:
• Appropriate airflow is required for this unit to operate correctly under normal and fault conditions. Suitable
spacing should be provided for the fans and vented ends to allow air flow in and out of the Power System.
When installing the Power System, the cubic area needed for air flow should be taken in consideration and
thermal testing must be performed as part of the end-product acceptance. There should be no barriers to the
fans and the vents of the Power System.
• Suitable fire enclosure must be provided as part of the end-use system investigation. The component shall be
installed in compliance with enclosure, mounting, packing, casualty and segregation requirements of end-use
system requirements.
• Leakage testing must be performed on end-use system.
• IEC 60601-1-4 not performed and must be considered for end-use system.
• Clause 15b limitation of Voltage and/or Energy must be performed on end-use system.
• The AC Line input cable and IEC connector are supplied by the user. Although not strictly required, it is strongly
recommended for additional protection that a fused IEC Input Module (or other external fuse arrangement) is
used with the Power System. The recommended fuse type is 10 A 250 VAC. Both Line and Neutral conductors
should be fused. The AC voltage input earth ground complies with bonding impedance requirements when it is
attached to a standard AC wall outlet. There is no required or provided earth ground bonding when the end-
use system is mobile.
• DC output short circuit and reverse polarity testing shall be considered on end use equipment.
• The DC voltage output cables are supplied by the user. The DC outputs from the Power System do not need to
be fused due to internal current limiting. If the user wishes to install fuse(s) for additional protection, fuse type
and sizing should be based on end-use requirements.
• The Battery Cable is supplied by the user. There is no requirement for fusing the Battery Cable since the Power
System includes a replaceable internal fuse. If external fusing is desired, careful consideration should be given
to fuse specifications for end-use requirements.
• Equipment has not been evaluated as AP/APG equipment. Must be considered as part of the end system
equipment.
• Component shall be properly bonded to the main protective earth termination in the end-use system and
comply with end-system bonding impedance requirements when it is attached to a standard AC wall outlet.
There is no required or provided earth ground bonding when the end-use system is mobile.
• Complies with requirements for US for outside the patient environment. For use within the patient
environment, evaluation must be performed as part of end system equipment.
This product contains electrical components. Observe local, state and federal guidelines for proper
disposal. The end product manufacturer should be contacted for procedures. For further information on
disposal, contact Amico Accessories Inc. at 1.877.264.2697.
Section 1: Safety Precautions
