Instructions for use
|
Atlan A300, A300 XL, A350, A350 XL SW 1.0n
293
Technical data
16.23 Device
combinations
This device can be operated in combination with other Dräger devices or with
devices from other manufacturers. Follow the accompanying documents of the
individual devices.
If a device combination is not approved by Dräger, the safety and the functional
integrity of the individual devices can be compromised. The operating organization
must ensure that the device combination complies with the applicable editions of
the relevant standards for medical devices.
Device combinations approved by Dräger meet the requirements of the following
standards:
– IEC 60601-1, 3rd edition (general requirements for safety, device combinations,
software-controlled functions)
– IEC 60601-1-2: 3rd edition (electromagnetic compatibility) or 4th edition
(electromagnetic interference)
– IEC 60601-1-8 (alarm systems)
Or:
– IEC 60601-1, 2n edition (general requirements for safety)
– IEC 60601-1-1 (device combinations)
– IEC 60601-1-2 (electromagnetic compatibility)
– IEC 60601-1-4 (software-controlled functions)
– IEC 60601-1-8 (alarm systems)
16.24
Emission of high-frequency energy
This medical device is equipped with an RFID module (radio frequency
identification) to enable wireless communication with Infinity ID accessories.
This medical device has been designed and manufactured to comply with emission
limit values for high-frequency energy. These limit values are incorporated in
international safety standards such as IEC 60601-1-2 and standards for radio
equipment such as EN 300330 and have been defined by regulatory authorities.
The RFID system of this medical device complies with Part 15 of the FCC
regulations and the license-free RSS regulations of Industry Canada. Operation is
subject to the following 2 conditions:
1. This medical device does not cause any harmful interference.
2. The medical device is not liable to damage caused by the reception of
interference, including interference causing undesired operating conditions.
Changes and modifications that have not been expressly approved by Dräger may
result in the user no longer being permitted to operate the device.
Dräger hereby declares that this medical device, including its radio equipment, is in
compliance with Directive 2014/53/EU.
The complete EU Declaration of Conformity can be viewed at the following internet
address: http://www.draeger.com/doc-radio
