2-Description; Precautions - Resonance R07A Benutzerhandbuch

2.1Precautions

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.
• To maintain the safety and full functionality of the R07A, it is important that instructions
set forth in this manual are strictly followed.
• Ensure compliance with environmental conditions (during transport, storage and
operating). If the device is moved from a cold location to a warmer one or vice versa, there
will be a risk of condensation build up. If condensation occurs the device must be allowed
to achieve normal temperature before it is turned on.
• To avoid damage to the device and leakage from the batteries, batteries should be
removed whilst the device is being stored.
• R07A does not have specific ingress protection. Care should be taken to avoid liquid
ingress. Immersion of the device may result in serious damage.
• 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.; this may induce malfunctions in their
performance. If the device is used adjacent to other equipment it must be observed that
no mutual disturbance appears.
• The R07A is intended to be powered from batteries or from a medical CE power supply
offered as an option. Using other supplies is not allowed. When used, position it so that
the power plug can be easily disconnected.
• The device should be placed at least 20 cm from a heat source.
• Be sure to use only stimulation levels, which will be acceptable for the patient.
• The transducers supplied with the R07A are calibrated to this device (see DHR documents
supplied with the device); exchange of transducers will require a recalibration.
• Sudden impacts or drops may cause damage to the device, which may affect its
performance and safety. Repairs should only be undertaken by a qualified technician.
If the R07A is connected to other devices with their own power source, the system conforms
to EN 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 EN 60601-1.
Any person who connects external equipment to the device connectors has formed a sys-
tem 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.
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2. Description