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 requirements as this product
(e.g. PC and/or printer) may lead to a reduction in the overall safety level of the system. The equipment
must comply with UL/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.
23. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of
the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential
installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful interference to radio communications. However, there is no guar-
antee that interference will not occur in a particular installation. If this equipment does cause harmful interference to
radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged
to try to correct the interference by one or more of the following measures:
–
Increase the separation between the equipment and receiver.
–
Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
–
Consult the dealer or an experienced radio/TV technician for help.
39
User Guide
Otometrics - MADSEN Zodiac
