ASP-I-MASPI-9 MedRx AVANT REMsp Installation Manual
Effective Date: 10-21-2016
14
Safety
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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
IP20.
•
Power is supplied by the USB cable connected to a computer. The USB computer power must be able to supply at least
400mA at the standard USB voltage.
•
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.
•
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 2 minutes.
•
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 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can be immediately withdrawn from the patient at any time.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.
•
The colored light on the device only signifies that the device is operational and the software is running (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 use of this equipment.
