General Warnings And Precautions - Interacoustics AD629 Instructions For Use Manual

2.3 General warnings and precautions

Read these instructions carefully and completely before using the product
Before connecting or while working with this AD629, the user should consider the following
warnings and act appropriately.
When connecting the AD629 to the computer, the following warnings must be observed:
This equipment is intended to be connected to other equipment thus forming a Medical Electrical
•
• System. External equipment intended for connection to signal input, signal output or other
connectors shall comply with the relevant product standard e.g., IEC 60950-1 for IT equipment and
the IEC 60601-series for medical electrical equipment. In addition, all such combinations – Medical
Electrical Systems – shall comply with the safety requirements stated the general standard IEC
60601-1, edition 3, clause 16.
• Any equipment not complying with the leakage current requirements in IEC 60601-1 shall be kept
outside the patient environment i.e., at least 1.5 m from the patient support or shall be supplied via a
separation transformer to reduce the leakage currents.
Any person who connects external equipment to signal input, signal output or other connectors has
•
formed a Medical Electrical System and is therefore responsible for the system to comply with the
requirements. If in doubt, contact qualified medical technician or your local representative. If the
AD629 is connected to a PC (IT equipment forming a system) ensure not to touch the patient while
operating the PC.
A Separation Device (isolation device) is needed to isolate the equipment located outside the patient
environment from the equipment located inside the patient environment. In particular such a Separation
Device is required when a network connection is made. The requirement for the Separation Device is
defined in IEC 60601-1 clause 16
To avoid the risk of electric shock, this equipment must only be connected to supply mains with protective
earth. Do not use any additional multiple socket-outlet or extension cord.
This AD629 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.
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
Following general cautions to be considered while working with this AD629
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 meant for single use to avoid cross
contamination.
The AD629 is not intended to be used in environments exposed to fluid spills.
D-0133833-A – 2022/09
AD629 - Instructions for Use - EN Page 5