Home
Untitled - Swissmedic
Contents
1. I rr d i arcomed ag Medical Systems Field Safety Notice FSCA identifier Flat ribbon cable check 04 2012 May 2012 Target audience Medical Engineers Biomedical Engineers Volumed pVP7000 Premium Volumed uVP7000 Classic Plus i Vol VP7 i Affected device olumed pVP7000 Lite Syramed uSP6000 Premium Syramed pSP6000 Classic Plus Description of the problem The ribbon cable which connects the display PCB with the main PCB of the above mentioned pumps may show aging effects after a certain time This aging effect reveals mainly in stiffening of the isolation of the ribbon cable where the ribbon cable is in contact with the hinge Detailed tests at arcomed ag have shown the following things e Intensive used pumps opening and closing the door more than 10 000 times may lead to small cracks of the isolation to the stiffened parts of the ribbon cable These cracks can lead to fluctuation of the contrast of the LCD and later failure of control elements e Normal used pumps 100 200 infusion sets per year the above mentioned stiffening has no impact on the functioning of the pump No cracks could be found at the stiffened parts of the isolation of the ribbon cable The stiffening of the isolation of the ribbon cable can be prevented by insertion of two special plastic foils between the hinge and the ribbon cable as shown in picture 1 In the case of Volumed pVP7000 it was also necessary to
2. Concern Flat ribbon cable check 04 2012 Company Address Name PC City Country Herewith confirm that have received read and understood this field safety notice and that will follow the recommendation of Arcomed AG as soon as possible Company stamp and Place Date Signature estes ents eee sstentesesttechiebeeeseesiesceNseee Page 4 of 4 IILL ot l arcomed ag Annex A Medical Systems FSCA identifier Flat ribbon cable check 04 2012 This instruction refers to the document Field Safety Notice FSCA identifier Flat ribbon cable check 04 2012 and must be applied to Volumed pVP7000 infusion pumps Intensive used devices and devices more than 4 years old with the following characteristics Safety check reveals No visible damage of ribbon cable could be found No cracks in the stiffened parts of the ribbon cable arcomed ag recommends to change the hinge and to add two special plastic foils above and under the ribbon cable The following steps should be carried out 1 Dismantle the door as described in the service manual chapter 6 2 2 2 Slit the black hinge and remove it from the ribbon cable 3 Turn down the ribbon cable slightly as shown in picture 1 and put over the grey hint as shown in picture 2 Picture 1 Preparing of ribbon cable for Picture 2 Pulling the hinge over the insertion of hinge ribbon cable 4 Insert plastic foil between hinge and ribb
3. Numbers after 76521106 all Serial Numbers before 76521106 Ribbon cable between two special plastic foils and grey hinge was used Normal used pump with a use of up to 200 set per year and less than 4 years old No action taken No action taken Intensive used pump or more than 4 years old Controll of the ribbon cable a no visible damage of the isolation Action according to annex A b Cracks in the isolation of the ribbon cable and strong stiffened part of the cable Action according to annex B Page 2 of 4 11 L L doles L d ag Field Safety Notice Medical Systems FSCA identifier Flat ribbon cable check 04 2012 2 Volumed uVP7000 LITE The following situations must be distinguished Serial Number all Serial Numbers after 38751104 Frequency of pump use Status of ribbon cable Ribbon cable between two special plastic foils and grey hinge was used No action taken Normal used pump with a use of up to 200 set per year and less than 4 years old No action taken Controll of the ribbon cable a no visible damage of the isolation Action according to annex A all Serial Numbers before 38751104 Intensive used pump or more than 4 years old b Cracks in the isolation of the ribbon cable and strong stiffened part of the cable Action according to annex B 3
4. Syramed pSP6000 Premium Classic Plus Frequency of pump use Status of ribbon cable Action Serial number all Serial Numbers after Ribbon cable is between noe i k 61031104 two special plastic foils No action taken Normal used pump with a use of up to 200 set per year and less than 4 years old No action taken all Serial Numbers before 61031104 arcomed ag recommend to change the ribbon cable on the occasion of the safety check and where appropriate to change the ribbon cable according to Annex C Intensive used pump or more than 4 years old Page 3 of 4 arcomed ag Field Safety Notice Medical Systems FSCA identifier Flat ribbon cable check 04 2012 Transmission of this Field Safety Notice This notice needs to be passed on all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action Contact reference person Dr Richard Meier Head Quality Management Arcomed AG Althardstrasse 150 CH 8105 Regensdorf e mail richard meier arcomed com The undersigned confirms that this notice has been notified to the appropriate Regulatory Agency ce f Dr Richard Meier Head Quality Management Important Information
5. ase proceed as follows o Dismantle the ribbon cable for the main PCB as well as from the display PCB See service manual 6 2 1 and 6 2 2 o Check the new ribbon cable if plastic foils are between the hinge and the ribbon cable Connect the new ribbon cable to the display PCB and be aware that the upper plastic foil sticks out of about 4 5mm from the hinge Picture 5 o Reassemble the door as described in the service manual chapter 6 2 2 Picture 5 Ideal placing of plastic foil compare to hinge and connector END Doc ID Annex B Page 1 of 1 ll d1 0 E l E arcomed ag Annex C Medical Systems FSCA identifier Flat ribbon cable check 04 2012 This instruction refers to the document Field Safety Notice FSCA identifier Flat ribbon cable check 04 2012 and must be applied to Syramed pSP6000 infusion pumps with the following characteristics Intensive used device or device more than 4 years old arcomed ag recommends to change the ribbon cable Mount a new ribbon cable complete with polyester foil and new grey hinge 1 Disconnect the ribbon cable form main PCB as well as from display PCB as described in i service manual chapter 6 2 2 2 Control if the new ribbon cable is delivered with two polyester foil 3 Connect the ribbon cable to the display PCB and pay attention that the upper polyester foil sticks out of the hinge of about 5 7 mm Glue the new hinge to the
6. display PCB see photo below 4 As glue arcomed ag recommends HENKEL SICOMET 8400 5 Reassemble the door and connect it to the pump END Doc ID Annex_C_E Page 1 of 1
7. on cable picture 3 Picture 3 Insertion of plastic foil Picture 4 ideal placing of the foil compare to the hinge 5 Reassemble the door and pay attention to the seal of the door and its correct insertion in the channel END Doc ID Annex A Page 1 of 1 ll Tt dob ot arcomed ag Annex B Medical Systems FSCA identifier Flat ribbon cable check 04 2012 This instruction refers to the document Field Safety Notice FSCA identifier Flat ribbon cable check 04 2012 and must be applied to Volumed pVP7000 infusion pumps Intensive used devices and devices more than 4 years old with the following characteristics Safety check reveals Visible damage of ribbon cable could be found Cracks in the stiffened parts of the ribbon cable arcomed ag recommends to change the ribbon cable Mount a new ribbon cable complete with plastic foil and new grey hinge Prior to start the change process please check if the ribbon cable is connected to the display print with aid of a fix connector picture 3 or via a separable connector picture 4 Picture 3 Fix connector Picture 4 Separable connector e A If the ribbon cable has a connector as shown in picture 3 than please send the ribbon cable with the display print to the following address arcomed ag Tech Support Althardstrasse 150 CH 8105 Regensdorf e B If the ribbon cable has a connector as shown in picture 4 than ple
8. optimize the hinge Therefore arcomed ag has developed a new hinge for the special plastic foil picture 2 and it is recommended to use this new optimized hinge together with special plastic foils Picture 2 left black old hinge right grey new hinge optimized for the special plastic foils Picture 1 Special plastic foils to prevent the stiffening of the insulation of the ribbon cable Flat ribbon cable complete with hinge and plastic foil can be ordered at arcomed ag item number 70242 for Syramed uSP6000 and item number 76269 for Volumed uVP7000 Please send us the serial numbers of the pumps repaired corresponds to 13 times opening and closing of the door per day Page 1 of 4 IILL ot E F arcomed ag Medical Systems Field Safety Notice FSCA identifier Flat ribbon cable check 04 2012 Advise on action to be taken by the Medical Engineers Bio Engineers arcomed ag recommends during the periodical maintenance of the pump to check the ribbon cable according to list below and if necessary to change the ribbon cable Note Between Volumed pVP7000 infusion pump and Syramed uSP6000 syringe pump two approach were applied due to different High Flex ribbon cables and fixing situations 1 Volumed pVP7000 Premium Classic Plus The following situations must be distinguished Serial Number i Frequency of pump use Status of ribbon cable Action all Serial
Download Pdf Manuals
Related Search
Related Contents
Ultraschallsensoren – RU Standard / Ultrasonic sensors Enlace - SciELO Colombia Training Manual and Users` Guide Using the Pennsylvania Patient Télécharger ce fichier User Manual Pyle PSTMH10 steam cleaner EOS 20D - BlaisePhoto 取扱説明書 KNRM Helps app abridged user's manual Copyright © All rights reserved.
Failed to retrieve file