Important Safety Instructions - Interacoustics AT235 Instructions For Use Manual

2.3 Important safety instructions

Read this instruction manual carefully and completely before using the product.
1. External equipment intended for connection to signal input, signal output or other connectors shall
comply with relevant IEC standard (e.g., IEC 60950 for IT equipment). In these situations, an optical
isolator is recommended to fulfill the requirements. Equipment not complying with IEC 60601-1 shall
be kept outside the patient environment, as defined in the standard (usually 1.5 meter). If in doubt,
contact qualified medical technician or your local representative.
2. This instrument does not incorporate any separation devices at connections for PC's, printers, active
speakers etc. (Medical Electrical System). A galvanic l isolator is recommended to fulfill the
requirements. For safe setup please refer to section 2.3.
3. When the instrument is connected to a PC and other items of equipment of a medical electrical system
assure that the total leakage current cannot exceed the safety limits and that separations have the
dielectric strength, creepage clearances and air clearances required fulfilling the requirements of
IEC/ES 60601-1. When the instrument is connected to a PC and other similar items be aware of not
touching the PC and patient simultaneously.
4. To avoid the risk of electric shock, this equipment must only be connected to supply mains with
protective earth.
5. Do not use any additional multiple socket-outlet or extension cord. For safe setup please refer to
section 2.3
6. This instrument contains a coin-type lithium battery. The cell can only be changed by service
personnel. Batteries may explode or cause burns, if disassembled, crushed, or exposed to fire or high
temperatures. Do not short-circuit.
7. 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 audiometer that are designated by the Interacoustics as repairable by service personnel.
8. For maximum electrical safety, turn off the power from a mains powered instrument when it is left
unused.
9. The instrument is not protected against harmful ingress of water or other liquids. If any spillage occurs
check the instrument carefully before use or return for service.
10. No part of the equipment can be services or maintained while in use with the patient.
1. Never insert or in any way use the insert headset without a new clean non defect test tip. Always
make sure that foam or ear-tip is mounted correctly. Ear tips and foam are single use.
2. The instrument is not intended to be used in environments exposed to fluid spills.
3. The instrument is not intended to be used in oxygen rich environments or use in conjunction with
flammable agents.
4. Check calibration if any parts of the equipment is exposed to shock or rough handling.
D-0133834-A – 2022/09
AT235 - Instructions for Use - EN Page 6