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ARC-I-MARCI-2 MedRx AVANT ARC Installation Manual
Effective Date: 10-21-2016
Safety
•
Regarding electrical safety, this device is designed to be used only by professionals in the hearing healthcare
industry.
•
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 an un-grounded mains power cable to a medical grade power supply and also supplied by the
USB cable connected to a computer. The USB computer power must be able to supply at least 500mA at the
standard USB voltage.
•
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.
•
The device warm-up time is less than 5 minutes.
•
Use only the 15 VDC, 2A medical power supply supplied with your Avant REM+: ETMA150200UD-P5P-IC.
•
The power supply cable should always be accessible in order to disconnect it from the supply mains.
•
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.
•
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 probe tubes and new foam
inserts are needed for each patient where applicable. 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.
•
The colored lights are as designated by ANSI S 3.6 and IEC 60645-1, conforming to the standard color designations
for audiology. 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.
•
The Instructions for Use (the Installation and Software Training manuals) are supplied as an electronic copy on a CD.
Paper copies of the manuals may be also requested from the company, and will be sent within one business day of
the request.
•
Refer to the Training manual and Help files for test options and descriptions.
