Warnings And Precautions - Interacoustics Callisto AC440 Instructions For Use Manual

1.5 Warnings and precautions

Throughout this manual the following meaning of warnings, cautions and notices are used:
WARNING
CAUTION
NOTICE
D-0101246-M – 2020/05
Callisto™ - Instructions for Use - US
The WARNING label identifies conditions or practices that may present danger
to the patient and/or user.
The CAUTION label identifies conditions or practices that could result in
damage to the equipment.
NOTICE is used to address practices not related to personal injury.
When connecting this device to a computer it is essential to insert a galvanic
separation between the device and the computer, unless the computer is
battery operated or supplied by a medical approved power supply. If connecting
directly to a PC it must be supplied from a medical isolation transformer fulfilling
the requirements of IEC/ES 60601-1.
Please note that if connection is made to standard equipment like an active
speaker, special precautions must be taken in order to maintain medical safety.
If used without galvanic separation, it must be supplied from a medical isolation
transformer fulfilling the requirements of IEC/ES 60601-1.
Do not touch the patient while operating PC, printer etc.
No modification of this equipment is allowed without Interacoustics
authorization.
Interacoustics will make available on request circuit diagrams, component part
lists, descriptions, calibration instructions, or other information that will assist
service personnel to repair those parts of this.
No part of the equipment can be serviced or maintained while in use with the
patient.
Although the instrument fulfils the relevant EMC requirements precautions
should be taken to avoid unnecessary exposure to electromagnetic fields, e.g.
from mobile phones etc. If the device is used adjacent to other equipment it
must be observed that no mutual disturbance appears, e.g. unwanted noise in
headphones. If disturbances are observed, try to separate the Callisto from the
disturbing device. Please refer to the section for Electromagnetic Compatibility
(EMC).
Do not disassemble or modify the product as this may impact the safety and/or
performance of the device.
The internal battery shall be replaced by authorized personnel.
Page 3