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.
15. Disposable accessories, such as eartips, should not be reused and must be replaced between patients to prevent cross-
infection.
16. We recommend that the device should not be stacked with other equipment or placed in a poorly ventilated space as
this may affect the performance of the device. If it is stacked or placed adjacent to other equipment, make sure that
the operation of the device is not affected.
17. 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 Astera² be restricted.
Likewise, we recommend that the instrument is not used in the vicinity of devices sensitive to electromagnetic fields.
18. Changes or modifications not expressly approved by the manufacturer could void the user's authority to operate the
equipment.
19. The device can be disposed of as normal electronic waste, according to local regulations.
20. If an electro-medical device is connected to a multiple-socket power outlet, this can result in a reduced level of
safety.
21. Use only the specified power supply.
See Technical Specifications in the MADSEN Astera² Reference Manual.
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.
The following applies only when used with the specified power supply, XP Power, type
PCM80PS24:
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 (2nd) and/or IEC
60601-1-1 and UL 60601-1 and CAN/CSA-C22.2 NO 601.1-90.
The following applies only when used with the specified power supply, External power supply,
Delta Electronics Inc., type MDS-090AAS24:
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 Medical Electrical Systems in IEC 60601-1-1 or 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. Do not touch non-medical parts, such as the laptop/computer or printer and the patient at the same time.
36
Otometrics - MADSEN Astera²
18 Warning notes
