otometrics madsen itera ii, Справочное руководство

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3. 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.
4. The device and any device to be connected which has its own power supply should be turned off before any con-
nections are established.
5. 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.
6. 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.
7. 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 Itera II be restricted.
8. The bone conductor cable and insert phone cable must not be removed or tampered with while
MADSEN Itera II 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.
9. 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 require-
ments as this product may lead to a reduction in the overall safety level of the system.
10. When selecting accessories connected to the RS232 socket and DC output of the device, the fol-
lowing points must be considered:
– Use of connected equipment in a patient environment
– Proof that connected equipment has been tested in accordance with Medical Electrical Sys-
tems 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).
– Do not touch the connectors of the device or connected devices and the patient at the same
time.
11. Grounding continuity should be checked periodically.
12. Avoid using extension cables. The increased length of the cable may increase the resistance of the protective earth
conductor beyond an acceptable level.
13. Operating at the wrong voltage may blow the fuses.For continued protection against fire hazard, replace fuses with the
same type and rating only.
14. To comply with Medical Electrical Systems in IEC 60601-1 3.1 edition:2012, computer and printer must be placed out
of reach of the client, i.e. not closer than approx. 1.5 meters/5 ft.
15. If the patient microphone is located within the patient area, the microphone should be classified as type B.
116 Otometrics - MADSEN Itera II
18 Standards and safety