otometrics Madsen Xeta, Справочное руководство

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14.2 Warning notes
1. This class of equipment is allowed in domestic establishments when used under the jurisdiction of a health care pro-
fessional.
2. Keep the unit away from liquids. Do not allow moisture inside the unit. Moisture inside the unit can damage the
instrument and it may result in a risk of electrical shock to the user or patient.
3. Do not use the instrument in the presence of flammable agents (gases) or in an oxygen-rich environment.
4. No parts may be eaten, burnt, or in any way used for purposes other than the applications defined in the Intended Use
section of this manual.
5. The device and any device to be connected which has its own power supply should be turned off before any con-
nections are established.
6. For safety reasons and due to effects on EMC, accessories connected to the equipment's outlet fittings must be
identical to the type supplied with the system.
7. It is recommended that an annual calibration be performed on accessories containing transducers. Furthermore, it is
recommended that calibration be performed if the equipment has suffered any potential damage (e.g. headphones
dropped on the floor).
Note that calibration has been performed only on the transducers supplied! If you wish to use any other transducer for
testing with the device, please contact your local distributor first.
8. Unwanted noise may occur if the device is exposed to a strong radio field. Such noise may interfere with the per-
formance of the device. Many types of electrical devices, e.g. mobile telephones, may generate radio fields. We
recommend that the use of such devices in the vicinity of MADSEN Xeta be restricted.
9. There are no user-serviceable parts inside the MADSEN Xeta cabinet.
For the sake of safety and in order not to void the warranty, service and repair of electro-medical equipment should
be carried out only by the equipment manufacturer or by service personnel at authorized workshops. In case of any
defects, make a detailed description of the defect(s) and contact your supplier. Do not use a defective device.
10. Changes or modifications not expressly approved by the manufacturer could void the user's authority to operate the
equipment.
11. The device is susceptible to electrostatic discharge. Avoid touching the power inlet during use of the instrument.
12. The bone conductor cable and insert phone cable must not be removed or tampered with while
MADSEN Xeta is powered on. Either disconnect the bone conductor or insert phone entirely from the
instrument, or make sure that the instrument itself is disconnected from the power source.
13. When assembling an electro-medical system, the person carrying out the assembly must take into account
that other connected equipment which does not comply with the same safety requirements as this
product may lead to a reduction in the overall safety level of the system.
14. When selecting accessories connected to the RS 232 socket of the device, the following points must be
considered:
– Use of connected equipment in a patient environment
– Proof that connected equipment has been tested in accordance with Medical Electrical Systems in
IEC 60601-1 3.1 edition: 2012, ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012) and CAN/CSA-C22.2 No.
60601-1 (2014).
15. Grounding continuity should be checked periodically.
92 Otometrics - MADSEN Xeta
14 Standards and safety