Description; Precaution - Resonance R16M Mode D'emploi

2.Description

2.1 Precaution

WARNING indicates a hazardous situation which, if not avoided, could result in death or
serious injury.
NOTICE is used to address practices not related to personal injury.
This instrument has been built and tested in compliance with product standards and left the
production factory in perfect technical safety conditions.
Prior to testing, the performance of the unit should be checked by the operator on their

own ear. This is to ensure that the unit produces results expected results.
Ensure that the correct tip size is selected to give a good seal in the ear canal. Use only the

single use ear tips provided with the unit. Replacement tips are available from RESONANCE
or one of their agents.
The device transducers and parts in contact with the patient should be cleaned following

every use. Appropriate antiseptic solution should be used in compliance to the
maintenance and cleaning section of this manual.
The device must be used only with the transducers provided by the manufacturer. Use of

alternative transducers, or their replacement, will require re-calibration.
The device is intended to be powered from Li-ion internal rechargeable battery or from a

medical CE power supply. Use of power supplies other than those provided by the
manufacturer is not permitted. When used, position so that the power plug can be easily
disconnected.
Although the instrument fulfils the relevant EMC requirements, precautions should be

taken to avoid unnecessary exposure to strong electro-magnetic fields, e.g. from mobile
phones, microwaves, radiotherapy devices, etc.; these may induce malfunctions in their
performance. If the device is used adjacent to other equipment it must be observed that
no mutual disturbance appears.
R16M does not have specific ingress protection. Care should be taken to avoid liquid

ingress. Immersion of the device may result in serious damage.
Any possible modification and/or alteration to this device is prohibited, without prior authorization
thereto by the Manufacturer.
If the R16M is connected to other devices with their own power source, the system
conforms to IEC 60601-1 must be checked under the responsibility of the installer; in the
event that isolation devices are used to achieve such conformity, these must comply with
IEC 60601-1.Any person who connects external equipment to the device connectors has
formed a system and is therefore responsible for the system to comply with the
requirements of IEC 60601-1.
If in doubt, contact your RESONANCE technician or local distributor for help.
Device not to be used in areas in which flammable anaesthetics or flammable agents for
disinfection or skin cleaning are applied.
Electric and electronic waste may contain hazardous substances and therefore must be
disposed of separately. Such products will be marked with the crossed-out wheeled bin
shown. The cooperation of the user is important in order to ensure a high level of reuse
and recycling of electric and electronic waste.Failure to recycle such waste products in an
appropriate way may endanger the environment and consequently the health of human
beings.
R16M User's Manual – Page 78