9. Do not store or operate the device at temperatures and humidity exceeding those stated in the Technical Spe-
cifications, Transport and storage.
10. 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.
11. Do not use the instrument in the presence of flammable agents (gases) or in an oxygen-rich environment.
12. 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.
13. Choking hazard! Do not leave eartips unsupervised within the reach of children.
14. The device and any device to be connected which has its own power supply should be turned off before any con-
nections are established.
To disconnect the device from the mains supply, pull the mains plug out of the wall mains
outlet. Do not position the unit so that it is difficult to pull the mains plug out of the wall mains.
15. 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.
16. 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,
contraphones, probes 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.
17. Disposable accessories, such as eartips, should not be reused and must be replaced between patients to prevent cross-
infection.
18. Unwanted noise may occur if the instrument is exposed to a strong radio field. Such noise may interfere with the pro-
cess of recording correct measurements. 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 this instrument be restricted as much as possible.
Likewise, we recommend that the instrument is not used in the vicinity of devices sensitive to electromagnetic fields.
19. Changes or modifications not expressly approved by the manufacturer could void the user's authority to operate the
equipment.
20. The device and power supply can be disposed of as normal electronic waste, according to local regulations.
21. Use only the specified power supply.
See Technical Specifications, Power supply.
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 and EMC requirements as this
product (e.g., cables, PC and/or printer) may lead to a reduction in the overall safety level or EMC com-
pliance level of the system. The equipment must comply with IEC 60950.
When selecting accessories connected to 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 IEC 60601-1 (3rd), AAMI ES60601-1
and CAN/CSA-C22.2 NO. 60601-1-08-CAN/CSA.
Do not touch the output DC plug of the power supply or connectors of the device or connected devices and
the patient at the same time.
22. To comply with IEC 60601-1(3rd) computer and printer must be placed out of reach of the client, i.e. not closer than
approx. 1.5 meters/5 ft.
Inmedico A/S - T830/T840
User Guide
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