Blatchford Orion3 Guide De L'utilisateur page 12

This device complies with part 15 of the FCC Rules.
Operation is subject to the following three conditions:-
1. This device may not cause harmful interference.
2. This device must accept any interference received, Including interference that may cause undesired
operation.
Contains pre-approved Bluetooth® module:
3.
FCC ID: PVH0946 IC: 5325A-0946
Liability
The manufacturer recommends using the device only under the specified conditions and for
the intended purposes. The device must be maintained according to the instructions for use
supplied with the device. The manufacturer is not liable for any adverse outcome caused by any
component combinations that were not authorized by them.
CE Conformity
This product meets the requirements of the European Regulation EU 2017/745 for medical
devices. This product has been classified as a class I device according to the classification rules
outlined in Annex VIII of the regulation. The EU declaration of conformity certificate is available at
the following internet address: www.blatchford.co.uk
Medical Device
Warranty
This device is warranted for 36 months.
Extended warranties of an additional 12, 24, or 36 months are available.
A service between 30 and 36 months is required for all extended warranties.
For the maximum 36-month extended warranty, a second service must be carried out between
54 and 60 months.
We reserve the right to void extended warranties if the device is not serviced at the required
intervals.
The user should be aware that changes or modifications not expressly approved could void the
warranty, operating licenses and exemptions.
The above may vary by market; consult your local representative for details.
See the Blatchford website for the current full warranty statement.
Reporting of Serious Incidents
In the unlikely event of a serious incident occurring in relation to this device it should be
reported to the manufacturer and your national competent authority.
Single Patient – multiple use
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938375/6-0520