Ordering Information - Blatchford Blade XT Instrucciones De Uso

9 Ordering Information

Part Number
189527
M8x16 flat point socket set screw
Bolt - flat align
Alignment Washer
Alignment Nut
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
Compatibility
Combination with Blatchford BladeXT device products is approved based on testing in
accordance with relevant standards and the MDR including structural test, dimensional
compatibility and monitored field performance.
Combination with alternative CE marked products must be carried out in view of a documented
local risk assessment carried out by a Practitioner.
Warranty
This device is warranted for 24 months.
The user should be aware that changes or modifications not expressly approved could void the
warranty, operating licenses and exemptions.
See the Blatchford website for the current full warranty statement.
Spare Parts
910457
180004
180003
180001
Single Patient – multiple use
9
938343PK1/1-0421