Warning Attention Achtung
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1. Warning Carefully read the enclosed instructions prior to use Attenzione Leggereattentamente leistruzioni allegate prina dell uso Attention Lire attentivement les instructions jointes avant l utilisation Achtung Vor der Benutzung die beiliegenden Hinweise aufimerksamlesen Advertencia Antes dewo lea cuidadosanente las instrucciones que se incluyen SORIN AT THE HEART OF MEDICAL TECHNOLOGY CUSTOMER LETTER OUTSIDE USA ONLY URGENT MEDICAL DEVICE FIELD CORRECTION Dideco Electa and Compact Family of Autotransfusion Wash Sets August 07 2006 Dear Sorin Group Customer We have received reports of difficulty in inserting the disposable wash set bowl used with the Dideco Electa and Compact family of autotransfusion machines The difficulty is due to a manufacturing process issue which has been corrected We wish to alert you to the issue and to remind you that proper bowl insertion is essential to the safe and effective use of the machine We would remind you that as noted in the Instructions for Use IFUs if a bowl cannot be inserted properly do not use it Please return it to us immediately for a non cost replacement If a bowl cannot be inserted in accordance with the IFUs there is a risk that the bowl s rotating seal could deteriorate during centrifuging releasing particulate into the processed blood These wash set bowls are shipped as sterile stand alone wash sets or as part of autotransfusion kits2. Following are the affected lot number s Starting from lot 0601230037 the items listed below may show difficulties to be inserted code Product KIT Product KIT 4125 _ 740C 125 Compact Wash Set Electa Wash Set 4126 740C 175 Compact Wash Set 4163M 740E 125 Electa Wash Set 4127 740C 225 Compact Wash Set 4164M 740E 175 Electa Wash Set 4149 740C 55 Compact Wash Set 4165M 740E 225 Electa Wash Set 4145 740C 125 Compact ATS Kit Electa ATS Kit 4146 740C 175 Compact ATS Kit 745E 125 Electa ATS Kit 4147 740C 225 Compact ATS Kit 745E 175 Electa ATS Kit 4148 740C 55 Compact ATS Kit 745E 225 _ Electa ATS Kit Please follow the attached instructions for all wash set bowls in order to avoid the risk of patient injury We remind you that the use of a 40 micron micro aggregate filter when re infusing collected blood is strongly recommended Any units failing the attached instructions should not be used and should be returned to your local Sorin Group representative for no charge replacement product If you have any questions please contact your local Sorin Group Customer Service We apologize for the inconvenience this may cause you and appreciate your understanding and cooperation on this issue Sincerely Marco Mantovani Director RA QA Sorin Group Italia S r l if k nne ame A ee 1 li zgi J i Moa gN MA AAD uA SORIN AT THE HEART OF MEDICAL TECHNOLOGY URGENT MEDICAL DEVICE FIELD CORRECTION Did
3. E FIELD CORRECTION Dideco Electa and Compact Family of Autotransfusion Wash Sets Dideco Autotransfusion Wash Set Bowl Instructions PURPOSE This verifies proper insertion of the Dideco wash set bowl in conjunction with the Field Correction letter dated August 07th 2006 PRINCIPLE A wash set is setup according to standard Instructions for Use IFU procedures The empty bowl is first soun manually and then spun automatically The bowl is carefully observed for abnormal noise abnormal vibration or wobbling abnormal rotation or spinning You will recognize abnormal vibration or wobbling if the bowl has not been inserted correctly and the bottom of the bowl does not fit flush with the centrifuge plate You will recognize when the bowl is inserted and positioned properly through a snap or click noise detected as the bowl fits flush with the centrifuge plate The rotation path of the bowl should be observed by viewing the shoulder of the rotating bowl from directly above The figure below shows the correct manner in which to observe the rotation of the bowl Bowl Collar S le XK l _ Ba ea es n SS p A ee ams re ee an ae LHA ai 5 Ds m ial tp Eee ees Ja m a et aid fh 2r a Aiii erat Pe stag Sts sere ee a if rasan eee ar ik Tirana A OW SNOUICE H i pa J fll ki i i i F a a i Vi af 1 7 al i i t 2 J if 1 r z 1 1 Internal white bell Loo
4. eco Electa and Compact Family of Autotransfusion Wash Sets Dideco Autotransfusion Wash Set Bowl Executive Summary Ensuring Proper Insertion of the Dideco Wash Set Bowl Viewing the bowl from directly above insert the bowl using two hands Press firmly until you hear a distinct snap or click sound as the bowl connects flush with the centrifuge plate If this sound is not obtained remove and reattempt insertion rotating bowl 120 If still not inserted correctly do not use the bowl replace wash set and return to your local Sorin Group representative Rotate the bowl manually to ensure bowl rotates properly on its axis ensure proper alignment by viewing from directly above shoulder of bowl as per figure below If not rotating correctly do not use the bowl replace wash set and return to your local Sorin Group representative Rotate using machine centrifuge If abnormal noise or vibration occurs do not use the bowl replace wash set and return to your local Sorin Group representative Bowl Collar View here CSD Dh x Do not view here p ee ai E ii r at a r i Saree a ie cee eral j 2r T a i i 5 me z tty te aoe n Teris eal Pe eee eee Pre e oe h if eran ere i it OW SNOUICGE ji i H th ar i rl a4 ij 1 i A 4 4 1 i a i Vt i Li 1 H a H ri 7 ky TE Mat i Internal white bell WSSGRNNeC Oar WETHE ARAB OE IMERICACTRRUNRHOGY URGENT MEDICAL DEVIC
5. en press STOP If the bowl shows abnormal vibration wobbling and or abnormal noise do not use the bowl replace wash set and return to your local Sorin Group representative IF DURING MANUAL ROTATION ABNORMAL SPINNING IS OBSERVED DO NOT USE THE BOWL REPLACE WASH SET AND RETURN TO YOUR LOCAL SORIN GROUP REPRESENTATIVE IF DURING CENTRIFUGAL ROTATION ABNORMAL NOISE VIBRATION OR WOBBLING IS DETECTED DO NOT USE THE BOWL REPLACE WASH SET AND RETURN TO YOUR LOCAL SORIN GROUP REPRESENTATIVE 4 If the wash set bowl passes these instructions continue with normal operation 5 If the wash set fails these instructions DO NOT USE THE BOWL REPLACE WASH SET AND RETURN TO your local Sorin Group representative
6. fuge rotary plate Fig 4 9 The bowl must be fitted keeping its axis perpendicular to the rotary plate After the fitting has been carried out rotate manually to ensure that rotation is non eccentric I eccentricity is detected remove the bowl and repeat the fitting procedure Note a The wash set bowl will fit correctly only when adequate pressure is used thereby ensuring the bottom of the bowl fits flush with the bottom of the machine centrifuge plate b Use two hands to press down on the body of the bowl until a snap or click is heard indicating that the bottom of the bowl touches the centrifuge plate evenly c If this sound is not obtained remove and reattempt insertion rotating bowl 120 If still not inserted correctly do not use the bowl replace wash set and return to your local Sorin Group representative 2 Manually spin the bowl and observe rotation per above figure Complete set up of roller pump and clamps Note a For Electa press the new procedure key to complete loading the disposable If the bowl size is not properly read this may also indicate improper bowl insertion Remove the bowl and re attempt insertion If still not inserted correctly do not use the bowl replace wash set and return to your local Sorin Group representative 3 Press the STAND BY and the PRIME key in sequence the centrifuge starts rotating while the pump is stopped Observe the bowl rotation for around 20 seconds th
7. k Here Do Not Look Here IF DURING MANUAL TURNING ABNORMAL ROTATION IS OBSERVED DO NOT USE THE BOWL REPLACE WASH SET AND RETURN TO YOUR LOCAL SORIN GROUP REPRESENTATIVE IF DURING CENTRIFUGAL ROTATION ABNORMAL NOISE VIBRATION OR WOBBLING IS DETECTED DO NOT USE THE BOWL REPLACE WASH SET AND RETURN TO YOUR LOCAL SORIN GROUP REPRESENTATIVE PROCEDURE 1 Follow Instructions for Use for correct wash set bowl insertion The main extracts from the IFU are listed below Electa Instructions for Use Chapter 5 Operating Instructions sets out the specific instructions regarding Fitting the Washing Set 5 Keep the three indentations fig 5 19 no 1 on the bowl base ring aligned with the corresponding metal disks on the centrifuge rotating plate and press the bowl fully downwards ensuring that the axis is perpendicular to the rotating plate Remove the protective spacer from the upper part of the bowl fig 5 19 no 2 Manually rotate the bowl to check for eccentricity If necessary remove the bowl and repeat the installation Compact User Manual Chapter 4 Operating Instructions sets out the specific instructions regarding Fitting the Disposable Sets 3 Remove the bowl from the container and remove the protective collar from the top ot the bowl Locate the three reference pins on the base of the bowl and fit it into the centrifuge well aligning these reference pins with those on the centri
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