Update Instructions
Contents
1. 4 i hea r Pais eh A Maquet Critical Care AB Mm 0438_04 DoclID MX 6242 version 01 status Approved 2015 03 31 11 00 by Hedman Karin Document type Page of M AQ U T UPDATE INSTRUCTIONS 8 10 GETINGE GROUP Document title Doc ID Hardware Update patient cassette locking device MX 6242 Force the absorber press inwards to dock C As a result of this the patient cassette will be forced upwards eae A l Lag fey al ot tah ened 2 T FEAD be o 5 daal z a i 1 Pull out the CO2 absorber The test passed if No click was heard during the test The patient cassette is still seated in its locked position Go to 3 4 The test failed if A distinct click was heard The patient cassette is loose from the locking device Go to 3 3 3 3 REPLACEMENT OF THE LOCKING DEVICE Replace the Patient cassette locking device by following the instruction below Open the rear cover of FLOW i instruction available in the service manual chapter disassembling and assembling Remove the CO gt absorber and the Patient cassette Remove the hook according to 3 1 Replacement of the hook Maquet Critical Care AB Mm 0438_04 DoclID MX 6242 version 01 status Approved 2015 03 31 11 00 by Hedman Karin Document type Page of M AQ U T UPDATE INSTRUCTIONS 9 10 GETINGE GROUP Document title Doc ID Hardware Update patient cassett2. Service Unit SSU and the Sales amp Service Partner SSP are responsible for planning of performance of the update and ordering necessary material in order to fulfill the implementation according to Immediate Update Promptly within the specified completion time frame Installed volume list for the SSU SSP 1 2 IMPLEMENTATION The SSU SSP is responsible for coordinating the customer completion date and placing material orders in a timely manner The SSU SSP is responsible for regulating the issuance of update orders to Field Service Engineer FSE along with all necessary information If a system cannot be updated because it is not affected jt cannot be located the customer refuses the update this information must be reported by authorized personnel from SSU SSP to MAQUET Critical Care MCC 1 3 REPORTING AND MONITORING Reporting and monitoring of this update is required and it contains of two parts to be addressed by the SSU SSP 1 Device correction letter intended for the US market and Field safety Notice intended for the rest of the world The distribution of the Device corrections letter Field Safety Notice to all concerned customers shall be confirmed to our Quality Department using the Confirmation of Distribution Refer to below document number for letter device correction letter and Field safety notice EVU 149158 Device correction letter EVU 149159 Field safety notice 2 Update Action as described in
3. gansaguence is stop of ventilation andthe notification for the user isthe leakage alann an pie Id_safety_ notice for FLOW1 _ Patient cassette latch NON US9081401505200202810 do CX DoclD EVU 149159 version 01 status Approved 2015 03 31 13 25 by Berken Lars MAQUET GETINGE GROUP apnea alarm and an expiratory minute volume low alarm There is also an indication showing absorber bypassed on the screen In manual mode the filling of the bag will be slower and the pressure cannot be kept Potential hazards The leakage can lead to improper ventilation which is a potentially dangerous situation for the patient if not corrected by the user Precautions Always make sure that you set an appropriate minute volume alarm and pay attention to a large difference between inspired and expired tidal volume Try to avoid excessive forces when switching patient tubings and CO absorber If you press the patient cassette back into position the leakage will stop This can be done quickly and the anesthesia does not have to be switched off Corrective action A field action is initiated to implement an improved patient cassette latch on affected installed base This Field Safety Notice is only applicable until the unit has been updated with the improved patient cassette latch We apologize for any inconvenience this may cause you and we will do our outmost to carry through this action as swiftly as possible Should you have questions o
4. DoclD EVU 149159 version 01 status Approved 2015 03 31 13 25 by Berken Lars MAQUET GETINGE GROUP URGENT FIELD SAFETY NOTICE 2015 03 31 Please forward this information to all relevant users biomedical staff in and risk management department concerned in your facility Subject Risk of leakage due to accidental displacement of patient cassette Products affected 6677200 FLOW i C20 All serial numbers up to 2753 6677300 FLOW i C30 6677400 FLOW i C40 Dear Valued Customer The purpose of this letter is to inform about a potential leakage situation due to an accidental displacement e g when switching patient tubings or replacing the CO absorber of the patient cassette There are no reported injuries It is only a low likelihood that this situation will lead to a clinical dangerous situation Our records indicate you have received one or more of these devices Please inform us of the quantity of units you have and the disposition of units that you no longer have Description MAQUET has discovered that the patient cassette in rare cases accidentally can be displaced e g when switching patient tubings or replacing the CO absorber Indications If you do a system checkout and the patient cassette is displaced the system checkout will not pass If the patient cassette is displaced when the machine is ventilating the leakage can be identified by a large discrepancy between inspired and expired tidal volume The clinical
5. cal Care AB Mm 0438_04 DoclID MX 6242 version 01 status Approved 2015 03 31 11 00 by Hedman Karin Document type Page of M AQ U T UPDATE INSTRUCTIONS 5 10 GETINGE GROUP Document title Doc ID Hardware Update patient cassette locking device MX 6242 2 7 RETURNS If the description in section 3 2 fails and the complete locking device is replaced the replaced locking device must be returned to MCC after completed update RMA is requested through the MSupport application https mreturn maquet com Home aspx 1 In MSupport request for an RMA 2 Open Helpdesk chose create RMA request 3 Chose category Other 4 Under Product Category chose Flow i 5 Fill in one of the 4 choices of references under reference no 6 Click on Search 7 Fill in your own reference ID 8 In the comment field refer to MCC 15 003 IU 9 Add part info as failure description refer to MCC 15 003 IU 10 Check the box replacement parts ordered insert replacement order references for correct refund amount 11 Save request press get RMA 12 Upon receipt of exchanged patient cassette locking device in Solna a credit will be issued 2 8 SPARE PARTS HANDLING N A Maquet Critical Care AB Mm 0438 04 DoclID MX 6242 version 01 status Approved 2015 03 31 11 00 by Hedman Karin Document type Page of M AQ U T UPDATE INSTRUCTIONS 6 10 GETINGE GROUP Document title Doc ID Hardwar
6. e Update patient cassette locking device MX 6242 3 UPDATE IMPLEMENTATION 3 1 REPLACEMENT OF THE HOOK Check that the system is affected See 2 1 Systems Products Affected Remove the CO absorber and the patient cassette Check that the system has the old version of the hook Refer to section 2 3 perquisite Open the latch 1 to remove tension on the spring Remove the two screws holding the hook 2 Replace the spring Mount the new hook using the new screws Maquet Critical Care AB Mm 0438_04 DoclID MX 6242 version 01 status Approved 2015 03 31 11 00 by Hedman Karin Document type Page of M AQ U T UPDATE INSTRUCTIONS 7 10 GETINGE GROUP Document title Doc ID Hardware Update patient cassette locking device MX 6242 3 2 FUNCTION TEST OF THE NEW HOOK After the replacement it is necessary to check the function of the new hook This is done by performing the following steps Mount the patient cassette and lock it with the latch a The absorber switch shall be in the unlock position at all time during the test Insert the CO absorber deliberately wrong A i e let the absorber inlet outlets push against the silicone seals B on the patient cassette inca a Ee i Fs oy S ee BNT oe a m p yen 4 iaie SOTE Pa E r nt TE s aj ae 4 Pee rie Ns j la a Pa i P oe ik we ol ca p eai Ba T a Pe F Fd C
7. e eee eee ener one eee 3 2 4 Special Tools DOCUMENES ccccccccceececseseeceseeceeeeeceuceseseeseaeeseaeeeseaeeseneessaas 4 209 Ord nng IMOMMAUOIN osisssa enaa aia daanin 4 2 6 Contents of the Update Kit ec ceccccseeceeeeeeeeeeeeeeeeesaeeeeseeeeseeeeeeeeseeeessees 4 RIN aE a ae cadets E EE AA EE A AE EEE ee 5 2 8 Spare Parts Handling cccccsccccssececceeseeeceeeeccesseecsseeeseaueecsegeeessegeesssaseesssaeees 5 3 UPDATE IMPLEMEINIEA TON wes esicduccavendiatnsnontivarataradiaweonenegconeateianees 6 3 1 Replacement of the NOOK ccccccccccceseseeceeeeeceeeeceeceseeeesseeeetseesseeesaeeseueessaas 6 3 2 Function test of the new NOOK ccccccceeccccececeeseeceeeesaeeeeseaeessaeeeseuseseeesseneeseas 7 3 3 Replacement of the locking CEVICE ccccceecceceeseecceeseeceeseeeceeseesseeeesseneesseaes 8 3 4 End test of FLOW I ccc cccceceeeeceeeeseeeeceaeesseueeseeeesseeeesaeeeseaeeesaeeesegeeesas 9 3 5 Customer INfOrMatiON cccccccccseccceeeeeceeeeeeeeeseeceseecesseeeeseecessueeesaeeeseeeeeseeeess 10 Maquet Critical Care AB Mm 0438_04 DoclD MX 6242 version 01 status Approved 2015 03 31 11 00 by Hedman Karin Document type Page of M AQ U T UPDATE INSTRUCTIONS 2 10 GETINGE GROUP Document title Doc ID Hardware Update patient cassette locking device MX 6242 1 RESPONSIBILITY OF SSU SSP 1 1 PLANNING This update is mandatory The MAQUET Sales amp
8. e locking device MX 6242 Open the latch and unscrew the screw behind the latch Remove the screw on top of the locking device Remove the locking device by pulling it out from the inside of FLOW i Mount the new locking device in the reverse order Mount the new hook including the spring using the new SCrews Close the rear cover 3 4 END TEST OF FLOW I Perform a System Checkout to make sure that the system works properly after the update Refer to the System Checkout as described in the User s Manual f applicable note in the Service report tool integrated in the Field Service System alt Service amp Settings that the update is performed Service key is required Maquet Critical Care AB Mm 0438_04 DoclID MX 6242 version 01 status Approved 2015 03 31 11 00 by Hedman Karin Document type Page of M AQ U E T UPDATE INSTRUCTIONS 10 10 GETINGE GROUP Document title Doc ID Hardware Update patient cassette locking device MX 6242 3 5 CUSTOMER INFORMATION Inform the customer of the purpose of this update refer to 2 2 Reason for the Update Also inform the customer that the issue described in the Device correction letter Field safety Notice has now been remedied Maquet Critical Care AB Mm 0438_04
9. nted to keep the cassette in locked position to prevent potential leakage when the cassettes are subjected to upward forces The new design was introduced in production of FLOW i as from S N 2754 2 3 PREREQUISITES Replacement of the hook part in the locking device and the following test is only required if the FLOW i system is equipped with an old type of hook It is therefore necessary to verify which existing version of hook is mounted by performing a visual inspection The new hook has an 45 gradation compared to 90 on the old hook Old Affected New Not Affected Maquet Critical Care AB Mm 0438_04 DoclID MX 6242 version 01 status Approved 2015 03 31 11 00 by Hedman Karin Document type Page of M AQ U T UPDATE INSTRUCTIONS 4 10 GETINGE GROUP Document title Doc ID Hardware Update patient cassette locking device MX 6242 2 4 SPECIAL TOOLS DOCUMENTS Standard service tools Update instruction this document FLOW i Service manual FLOW i User s manual 2 5 ORDERING INFORMATION Place an order as follows for each system to be updated Patient cassette hook kit P N 68 83 732 If the test described in section 3 2 fails the complete locking device must be replaced Locking device P N 66 85 380 List the system Serial Number on FLOW i on the order 2 6 CONTENTS OF THE UPDATE KIT Patient cassette hook kit P N 68 83 732 contains the following parts 2 2 Screws Maquet Criti
10. r require additional information please contact your local MAQUET representative Sincerely Peter Wedar Lars Berken Global Product Manager Anesthesia Vice President Quality Management MAQUET Critical Care AB SE 171 54 Solna Sweden www imaquet com Mm 0191 04p Page 2 of 2 EVU 149159 00 14 Fie Id_safety_ notice for FLOWIi Patient cassette latch NON US9081401505200202810 do CX DoclD MX 6242 version 01 status Approved 2015 03 31 11 00 by Hedman Karin Document type Page of M AQ J T UPDATE INSTRUCTIONS 1 10 GETINGE GROUP Document title Doc ID Hardware Update patient cassette locking device MX 6242 UPDATE INSTRUCTIONS MCC 15 003 1U PRODUCT FLOW TITLE HARDWARE UPDATE PATIENT CASSETTE LOCKING DEVICE ISSUE DATE 2015 03 31 UPDATE TYPE IMMEDIATE COMPLETION DATE 2016 03 31 Contents Page 1 RESPONSIBILITY OF SSUSSP suenatiscnsseatcsiesbacinmnsnsecnesiminnteinciet 2 Net ROON ee a a e E A EE 2 1 2 dImplementatiON sisissnrininineii naai a ai ia 2 1 3 Reporting and Monitoring cccccseeeeeeeeeeeeeeeceeeeseeeeeseeeeseeeesseseeseueesaeeeeseeeeseees 2 2 UPDATE INFORMAT ION s onnonnonnsnnsnnsnnnnnnnnnnnnnonnonronrenrenrerrerrernerrernens 3 2 1 Systems Products Affected ccccccccssccccseeeeeceeseecceeseccsseeeceeaeesseuseeessaeeessageees 3 2 2 Reason for the Update cc cccccesceceeseceeeeeseeeeseseeseaeeesaeeeseaeeeseeeeseeseeseneeseas 3 2 3 a 610 16 3 oe eee eee er
11. this Update Instructions is the actual update to be performed by the FSE The SSU SSP is responsible for monitoring the completion date and the number of updates completed Completion of the update must be reported to MCC via the web application MBase If reporting in MBase is not possible the reporting must be done to Update Reporting MCC madquet com There is no need to wait with the reporting until the very last unit has been updated we appreciate a continuous reporting from you Maquet Critical Care AB Mm 0438 04 DoclD MX 6242 version 01 status Approved 2015 03 31 11 00 by Hedman Karin Document type Page of M AQ U T UPDATE INSTRUCTIONS 3 10 GETINGE GROUP Document title Doc ID Hardware Update patient cassette locking device MX 6242 2 UPDATE INFORMATION 2 1 SYSTEMS PRODUCTS AFFECTED Affected units FLOW i All FLOW i with a serial number up to 2753 2 2 REASON FOR THE UPDATE Due to tolerance issues the patient cassette can get partly disconnected when exposed to external forces e g when the CO2 Absorber is replaced This is indicated to the user by a leakage alarm The normal action in a leakage situation is to switch to manual ventilation but neither manual ventilation nor emergency ventilation works as the leakage is in the breathing circuit In order to ventilate the patient the leakage must be found and corrected or an external manual bag must be used A change of the locking device has been impleme
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