16
853591-1_AIR-I-MTINI-1 Avant AIR+ Installation Manual
Effective Date: 12-08-2017
Safety
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Regarding electrical safety, this device is designed to be used only by professionals in the hearing
healthcare industry.
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It is Class II Medical Electrical (ME) equipment that is part of an ME system.
This device
provides Type B protection
(Type B equipment, Type B applied part)
•
This device is not protected from ingress of water. The water protection level is
IP21.
•
Power is supplied by the USB cable connected to a computer.
•
A USB Optical Isolator, with a minimum of 1000 DC volt isolation, should be placed in-line between the
computer’s USB connection and the MedRx device. The Optical Isolator should be powered by a
power supply that conforms to IEC 60601-1. The computer, Optical Isolator’s power supply and the
speaker’s power supply should be connected to the Medical Grade isolation transformer that conforms
to IEC 60601-1. Follow the manufacturer’s instructions for installation and use.
•
The computer used with this device should conform to the requirements of IEC 60950-1 and IEC
60601-1-4.
•
A MULTIPLE PORTABLE SOCKET-OUTLET or extension cord shall not be connected to the system.
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The device warm-up time is less than 2 minutes.
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Do not connect items that are not specified as part of the system.
•
The use environment should be between 10°C and 35°C
, humidity within 30% to 90%
and an atmospheric pressure range from 80 kPa to 104 kPa.
•
Storage temperature range at least from 0°C to 50°C
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All components with patient contact are made of bio-compatible materials.
•
This device does not produce any adverse physiological effects.
•
Install the device as directed by this manual to achieve optimal use. Clean accessories per the
cleaning instructions prior to use. No Sterilization is required for components of this device. However,
new foam inserts are needed for each patient where applicable and cleaning of the device and
accessories should follow the procedure outlined below.
•
The device is not intended to be operated in an environment with anesthetics, oxygen or NO. It is not
an AP or APG device. This ME System is not intended for use with flammable anesthetics.
•
This device uses Type B application parts temporarily placed on the patient during testing. They are
nonconductive and can be immediately withdrawn from the patient at any time.
•
The device is intended for continuous operation.
•
The computer and the MedRx device or accessories may be located in the patient environment if
required.
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The colored lights are as designated by ANSI S 3.6 and IEC 60645-1. They signify that either the left
(blue) channel is active or the right (red) channel is active, or no channel is active (green). The colors
do not signify any dangerous or faulty condition.
•
Contact the local MedRx distributor for safe and proper disposal of this equipment.
Proper
disposal may require that it be sent to collection facilities for recovery and recycling.
•
All repairs should be sent to MedRx for evaluation and / or repair. However, necessary diagrams and
repair instruction will upon request be provided to authorized repair personnel.
•
There are no known contraindications for the use of this equipment.
