User Manual
Contents
1. M bag on the bottom Figure 7 16 Unlock the temporary clamp Redcells flow into the filter and leukocytes are filtered and they are collected in the SAG_M bag Caution Beware not to lose air and a flat tube for increasing filtration and lock the clamp at one time 17 Filtration time is 25 mins in average at a room temperature 18 Invert bag several times to mix thoroughly then allow tubing to refill with anticoagulated blood from the bag Repeat this procedure twice Figure 4 19 If quadruple bag is used lock main bag with BC with PLT clamp rinse the bag and rest it for an hour 20 Centrifuge main bag and ST transfer bag at 500 g for 6 mins at 20 C Caution Centrifuge settings may vary according to the centrifuge brand used 21 Separator transfer PLTs to the transfer bag Caution PLTs are separated after centrifuge 22 PLTs can be stored ina TOTM transfer bag up to 5 days in incubator under agitation 9 TRANSFUSION 1 Inspect the container and blood for any defects 2 Before transfusing the blood make sure that serological test results are acceptable cross match test results match with the recipient If appropriate apply cross match again at bed side 3 Use transfusion set compatible with ISO EN 1135 4 4 Hold the top part of the T port with one hand and bag from the bottom part of T port with other hand and twist of the upper part by 270 Figure 8 5 Keep holding the bag from T port remove the cap of the transfusion spike with o2. prevent leakages of plasma into filter Separate the plasma in accordance with the extractor operation manual Break the break off part at the opening of the bag by turning left and right Figure 5 and transfer the plasma into the the transfer bag labelled 5 7 The transfer bag labelled 5 contains plasma and the transfer bag connected to it are removed from the bag system Check number 19 for continue with product gaining Figure 5 8 Hook the SAG M bag to filter hanger from a height of 150 cm Figure 6 9 Break the breakaway part at the output of SAG M bag by turning left and right Figure 5 10 SAG M solution flows through the filter 11 After SAG M process is finished the tube is clamped under leukocyte filter with temporary clamp CAUTION Beware to put the clamp to the closest point of redcells bag 12 Rinse the redcells bag before hang up Caution Rinsing the bag decreases filtration time 13 Reverse the whole kit hook redcell bag to the top and the SAG M bag will be on the bottom Figure 7 14 Unlock the temporary clamp Redcells flow into the filter and leukocytes are filtered and they are collected in the SAG _ M bag Figure 3 ir je e a ar Hie benoe Pn kt kk 5 58720 Rev 1 Issue Date 27 08 2014 Page 1 2 CAPA NO 125 14 15 Caution Be sure that the tube is flat to avoid remaining of air in the filter and to increase the filtrati
3. xansux BLOOD BAGS USER INSTRUCTIONS BLOOD BAG SYSTEMS WITH RBC FILTER C 1008 DESCRIPTION For Leukodepleted Red cells Plasma and Platelet collection separation and storage of human blood components INDICATIONS See Guide to the preparation use and quality assurance of Blood Components GENERAL PREPARATIONS BEFORE USAGE 1 Open the outer wrap at the tear notches and remove one blood bag system 2 Apply blood pressure cuff or tourniquet on donor s arm identify venipuncture site and release the cuff or tourniquet 3 Disinfect the venipuncture site Cover the area with sterilized gauze strip and do not touch until the time of venipuncture CAUTION Beware of iodine 4 sensitive donors 4 Before venipuncture inspect the blood bag system tubing and needle for visual defects and discoloration 5 Signs on the needle protector and hub should be the in the same line Apply some pressure to determine any leakages 6 Place the collection bag below the level of donor s arm 7 The anticoagulant and additive solutions should be checked for containing appropriate volume color or particule contaminants 2 CAUTION While opening the blood bag system blood taking tube should be held from needle protector not from the needle safety cover Pay attention not to lock the needle safety cover before collection of blood by mistake USER INSTRUCTIONS 3 1 BLOOD COLLECTION IF SAMPLING BAG SYSTEM IS USED FOLLOW NUMBER 1 4 IF NOT CONTINUE WI
4. TH NUMBER 5 1 Before the needle protector is uncapped close the clamp on the line connected to collection bag If the bag system has a breakaway part there is no need to close the clamp 2 Break the break away part on the tube to the sampling bag holder Figure 1 No 2 Figure 2 No 3 Figure 2 3 Follow the following steps according to the sampling bag system a Tubing System i Blood samples sampling tubes are inserted into the tube holder and necessary blood is taken Figure 1 No 3 ii CAUTION Take the samples to bigger tubes first iii The clamp on the tubing to the bag is opened and blood taking starts Figure 1 No 1 b Sampling Bag System i Take blood to the sampling bag Figure 2 No 5 ii The clamp on the tubing to the sampling bag is closed Figure 2 No 2 iii The clamp on the tubing to the bag is opened and blood taking starts Figure 2 No 1 iv Sampling bag is placed in palm in a position of sampling bag tube holder is to be stayed below Sample tubes are inserted in tube holder connected to the sampling bag and sufficient blood sample is taken Figure 2 No 4 CAUTION Sample blood in the sampling bag should immediately transferred to the tubes otherwise they get coagulated NOTE After sampling break the breakaway part on the tubing to collection bag for the systems with donor line breakaway 4 The tube with the tube holder is hanged on to donor s wrist in a way not to compress the needle continue with
5. ert bag several times to mix thoroughly then allow tubing to refill with anticoagulated blood from the bag Repeat this procedure twice Figure 4 22 For cross match purposes seal the tubing attached to the collection bag into segments leaving a segment number clearly and completely readable The closest segment number to the collection bag should always remain attached to the bag for identification 23 Check the blood bag again for any faults 24 Make sure all the donor information required is filled out on the label of the blood bag 25 Immediately after collection whole blood should be placed at 1 6 C in a blood bank refrigerator which is designed for this purpose If platelets will be separated do not cool the blood but wait under 20 24 C for a min of 1 hour with 45 angle For gaining fresh freezed plasma and platelets finish all the steps within 8 hours after collection COMPONENT SEPARATION CLASSICAL Triple Bag Sets Intended for PLT separation with PRP Load the full blood filled bag system in the centrifuge buckets Caution Proper positioning of the bags will prevent burst of the bags during centrifugation Centrifuge at 2500 g for 15 minutes under 22 C Caution Centrifuge settings may vary according to the centrifuge brand used Place the centrifuged bag to the blood component extractor Clamp all tubing except for the tubing of transfer bag used in plasma separation Meanwhile put a clamp on the tube connected with filter to
6. et or deflate the pressure cuff 16 When blood taking is done to remove the needle hold the hub with one hand between the thumb and index finger while the other hand holding the sterile gauze and pull the hub without exerting pressure completely Let the donor keep sterile gauze on the point of entry of the needle into vein 17 Hold the needle with one hand as the tip stay at the upper position wait for flowing off the blood to bag in the blood taking tube 18 The clamp on the tube to the bag is closed after that step Put a knot on the systems without sampling bag CAUTION When the needle is locked if the clamp is not closed there is a risk of blood flushing from the needle safety cover 19 For the blood bag systems with needle safety cover while holding the needle with one hand hold the needle safety cover with the other one than leave the needle pull the needle to the safety cover by pulling the tube under the safety cover and be sure that it is locked Figure 3 No 6 CAUTION To prevent accidental injuries or contamination of the personnel insert the needle into the locked system or throw it to the medical waste 20 The blood taking tube is closed from under the Y port with tube sealing device and the needle is removed from the system Caution Throw locked needle kit to the medical waste Figure 4 21 Strip donor tubing as completely as possible into bag starting at seal Work quickly to prevent the blood from clotting in the tubing Inv
7. number 9 5 Ifthe blod bag system does not have a sampling bag samling port put a temporary clamp or knot to blood taking tube 6 6 Reapply tourniquet or inflate blood pressure cuff until previously selected vein is prominent again 7 Hold the needle from marked side To remove the needle cap twist to break the seal between the needle and its cap and remove it by sliding it down the axis of the needle CAUTION Bu sure not to touch the cannula 8 Apply the venipuncture immediately Venipuncture is very important for a non coagulated blood 9 Strap the needle to the donor s arm 10 Mix blood and anticoagulant gently and periodically approximately in every 45 seconds during collection If a mixer or a collection system is used please refer to their operator s manual 11 Make sure there is continuous blood flow If there is continuous adequate blood flow and constant agitation blood collection is expected to be completed under 12 minutes CAUTION If it s above 12 minutes collected blood may not be suitable for Platelets Fresh Frozen Plasma or Cryoprecipitate AHF 12 Collect the quantity of blood within the limits indicated on the bag label Monitor the blood being drawn 2 13 After blood collection is finished blood collection mixer collects the desired blood and stops the collection by clamping the blood collection tube 14 Stop the blood taking and agitating device and after opening the clamp of the device 15 Loosen the tourniqu
8. on speed pull the clamp at once 16 Filtration time is around 25 minutes at controlled room temperature Caution Do not use the product if the filtration time is less than 5 minutes 17 After the procedure seal the tube under filter 18 Samples for cross match can be taken from tube of the bag Invert bag several times to mix thoroughly then allow tubing to refill with anticoagulated blood from the bag Boot this proosan twice Figure 3 Closest segment to collection bag always remains with the bag for identifying 19 Red cells should be placed into blood bank refrigerators under 1 6 C 20 IfPLTs will be separated plasma is re centrifuged at 3000 g for 10 mins 21 After centrifuge PLTs remain at the bottom and plasma on the top of the bag 22 Place the plasma bag to the blood component extractor and unlock the clamp 23 Transfer plasma to the empty transfer bag 24 PLTs can be stored up to 5 days in incubator under agitation if they are transferred into the transfer bag from PVC TOTM 25 Store the plasma in the freeze If the separation takes place within 6 hours after collection it can be stored at 18 C 25 C for 3 months 30 C 40 C for 6 months and at lower temperatures for 12 months WV r TOP amp BOTTOM Triple and Quadruple Bag Sets Intended for PLT separation by BC L p 1 Place the bags into centrifuge bucket as the breakaway part stands on above Caution Place the filter into the housing Proper positioning of the bags
9. rotector is opened Bars on the needle should be in the same line Figure 9 Do not recap the opened needles Do not use if fluid path closures are loose and not intact Do not vent Store blood between 1 6 C Do not add medication to blood Cross match the contents of the bag with recipient before transfusion Use transfusion sets in compliance with ISO EN 1135 4 Figure9 Mix thorougly before use and if necessary store under controlled conditions to achieve the appropriate temperature When frozen plastic is more fragile After usage Single use only Throw to medical waster after use Caution In case of reuse there is infection risk CAUTION This medical device contains di 2 etilhekzil ftalat DEHP Considering the animal data s precautions should be taken to restrict to be a subject of DEHP especially for certain patients affected on their reproduction and development processes These patients are newborn boys infants and children prepubertal boys and pregnant and nursing mothers Please check out the updated literature to give a conscious decision ansur KANSUK LABORATUARI SANAY VE T CARET A KANSUK Eski Londra asfalt Be yol Mah No 4 34295 Sefak y STANBUL T RK YE Tel 90 212 592 15 76 Faks 90 212 580 37 72 www kansuk com e mail kansuk kansuk com kt kk 5 58720 Rev 1 Issue Date 27 08 2014 Page 2 2 CAPA NO 125 14
10. ther hand 6 Insert the spike by of its length into outlet port Do not touch the spike of the transfusion set and open outlet port to prevent contamination 7 After inserting the spike squeeze the bag to the level that transfusion set filter is filled with blood 8 Hook the bag from its holder GENERAL CAUTIONS During storage and transportation l loaded in a way to prevent fall over 2 Before opening overwrap 3 4 gt After opening overwrap 6 7 Before usage Se Se O 10 11 12 13 14 15 During shipment up to two blood bags shippers shall be carried at the same time manually or on a trolley Parcels should not be dropped and or crushed and should be In the warehouse up to seven parcels can be stored on top of each other and in a way to prevent fall over Store the overwrapped bags at clean dry and cool places Do not use if there is visible sign of deterioration on the overwraps Blood bags are packed with sterilized Store the bags in their outer wraps at clean dry and cool places Bags should be used within 10 days after removal of the transparent overwrap Store the closed overwraps at clean dry and cool places Intended for human blood and blood components Sterile and non pyrogenic Steam sterilization Do not use unless solutions are clear Do not use if there is visible sign of deterioration on the bags Protect the bag and tubing from sharp objects Do not use if needle p
11. will prevent burst of the bags during centrifugation T 2 Ifthe blood will be used as a whole blood break the breakaway part on the main bag and transfer whole blood into 500 ml capacity transfer bag Age ake 3 Centrifuge at 3500 g for 15 mins at 22 C Caution Centrifuge settings may vary according to the centrifuge brand used P 4 a i bl 4 Place the centrifuged bag to the blood component extractor If quadruple bag is used seal the PLT bag s tube 5 Use the blood component separator according to it separator using manual SAG M 6 Firstly break the main bag s breakaway part then the transfer bags Figure 5 7 Separator transfers plasma to the plasma bag redcells to the transfer bag while keep Buffy Coats remaining in the main bag _ ae 8 When the procedure is done seal transfer bags with plasma and redcells than remove them from the kit 9 Store plasma as identified in number 24 Figure 6 Figure 7 10 Hook the SAG M bag to filter hanger from 150 cm high Figure 6 11 Break the breakaway part at the output of SAG M bag by turning left and right Figure 5 12 SAG M solution flows through the filter 13 After SAG M process is finished lock the tube under leukocyte filter with clamp CAUTION Beware to put the clamp to the closest point of redcells bag 14 Rinse the redcells bag before hook up Caution Rinsing the bag decreases filtration time 15 Reverse the whole kit hook redcells to the top and leave the SAG
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