21. Use only the specified power supply.
See Technical Specifications in the MADSEN Astera²Reference 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.
19
Manufacturer
Natus Medical Denmark ApS
Hoerskaetten 9, 2630 Taastrup
Denmark
+45 45 75 55 55
www.natus.com
19.1
Responsibility of the manufacturer
The manufacturer is to be considered responsible for effects on safety, reliability, and performance of the equipment only
if:
•
All assembly operations, extensions, re-adjustments, modifications or repairs are carried out by the equipment man-
ufacturer or personnel authorized by the manufacturer.
•
The electrical installation to which the equipment is connected complies with EN/IEC requirements.
•
The equipment is used in accordance with the instructions for use.
42
MADSEN Astera²
19 Manufacturer
