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18.156_En_Safety Notification_No.5_2011

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1. Safety Notification No 05 2011 NRGUS GODAN Consignee Hospitals clinics medical practices end users and technical services Product Syringe pump A600S Subject Configuration settings address 43 Syringe clamp diameter outside control Date October 2011 Sender CODAN ARGUS AG Enclosure CH 6340 Baar App to 18 156 Safety instructions Dear valued customer Please forward the following information to all responsible staff within your organisation Description of the problem Thanks to a report from a Swiss hospital it was possible to detect an unwanted and adverse alignment between the device and configuration a The configuration address 43 is switched off No 43 OFF Syringe clamp diameter outside control b The driving head of the syringe pump is damaged c The syringe piston was incorrectly fixed or not fixed at all to the grey clamps on the driving head unit Outcome When all three events a c occur at the same time the device can be started without the medication being pumped and without triggering an alarm Solution In order to prevent this problem from occurring and to ensure that the corresponding alarm is triggered the address 43 must be activated No 43 ON Action As part of our measures for continuous optimisation we request that you implement the following instructions in the market a The setting of address 43 Syringe clamp diameter outside control must be checked on all devices
2. from the A600 S generation and should if necessary be activated as intended by the default setting No 43 ON b The alteration to the pump should be carried out by the technical service via the configuration menu c This does not affect syringe pumps from the new A606 S generation The users of these syringe pumps should be informed of the risks and precautions described above and should receive additional training if necessary For further information please contact us at 41 0 41 785 09 44 or info codanargus com We thank you for your support Yours faithfully CODAN ARGUS AG lt a a hy ie itt Christine Kipfer Michael LUscher Head of Product Management Quality Assurance 18 156 CODAN ARGUS AG 31 10 2011 Mil 1 1 ARGUS Safety instructions for correctly starting up the syringe pump A600 S As a basic principle chapter 3 3 Pump Set up points d and e of the A600 S user manual applies lt is particularly important to note that the driving head unit must be moved as far as the syringe piston and that the grey clamps lock into place by releasing the lever Check The end of the syringe piston must be positioned flush with the driving head unit see red arrows App to 18 156 _En_ Safety Notification No 05 2011 October 2011

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