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P/N 85213-30, Manual revision: B

Chapter 6

Ensuring Safety and Quality for an
MCS+ Procedure

HANDLING THE MCS+ EQUIPMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

Storing the device and material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Inspecting the material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Transporting the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

PREVENTING PROBLEMS DURING AN MCS+ PROCEDURE . . . . . . . . . . . 6-3

Understanding the risk of hemolysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Avoiding the consequences of flow restriction  . . . . . . . . . . . . . . . . . . . . 6-3
Avoiding bowl misalignment  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Avoiding overheating due to mechanical situations  . . . . . . . . . . . . . . . . 6-4
Controlling for red cell overrun  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4

WARNINGS FOR THE OPERATOR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5

Electrical shock hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Leakage current control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Mechanical hazards/rotating parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Power outlet connection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Communicable disease precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6

Содержание MCS+

Страница 1: ...Drive Bothwell Scotland G71 8BS Great Britain EC REP Working with the Haemonetics MCS Operation Manual Printed in France Haemonetics Corporation 400 Wood Road P N 85213 30 Manual revision B Braintree...

Страница 3: ...tly used by a properly trained operator Any failure to respect the procedures as described could result in impaired function of the equipment as well as in injury to the operator and or patient donor...

Страница 4: ...Pta nsk ho C 8 60200 Brno Czech Republic Tel 42 05 4121 2400 Fax 42 05 4121 2399 Haemonetics France S A R L 46 bis rue Pierre Curie Z I Les Gatines 78370 Plaisir France Tel 33 1 30 81 41 41 Fax 33 1...

Страница 5: ...escribing the MCS Centrifuge System PRESENTING THE MCS CENTRIFUGE SYSTEM 1 2 CENTRIFUGE BASE 1 3 Using a mechanical centrifuge chuck 1 3 Using a vacuum centrifuge chuck 1 4 Applications for a centrifu...

Страница 6: ...zard waste bag 2 18 Chapter 3 Describing the MCS Control Panel PRESENTING THE MCS CONTROL PANEL 3 2 UPPER CONTROL PANEL 3 3 Donor flow indicator lights 3 3 Display screen 3 3 Explaining the screen lay...

Страница 7: ...rol panel 5 2 Pressure monitors 5 3 Air detectors 5 3 Optical sensors 5 3 Fluid detector s 5 4 Centrifuge components 5 4 Pumps 5 5 Filter screens 5 6 Bar code reader 5 6 Pressure cuff 5 6 CUSTOMER SER...

Страница 8: ...7 4 Power failure procedure 7 4 Manual gravity infusion procedure 7 4 Repeat venipuncture procedure 7 6 AC depletion procedure 7 7 Chapter 8 Consulting Reference Information EXPLAINING COMMONLY USED...

Страница 9: ...his manual xiii What is apheresis technology xiii What is the Haemonetics Mobile Collection System xiv What are the characteristics and special features of the MCS xv Symbols found in this document xv...

Страница 10: ...x Preface P N 85213 30 Manual revision B The Haemonetics MCS LN09000 220E ED...

Страница 11: ...er maintenance and correct handling to ensure optimal quality apheresis results This manual covers MCS device information for list numbers LN9000 220 E LN9000 220 ED LN9000 220 EW and LN9000 110 EWC I...

Страница 12: ...a protocol Once the operator has initiated an MCS procedure component collection will proceed automatically The appropriate amount of anticoagulant solution will be mixed in the disposable tubing with...

Страница 13: ...feedback and on line assistance The Haemo Calculator an integral facet of the MCS function which cal culates processed procedure volumes based on individual donor patient characteristics and targeted...

Страница 14: ...r the operator Symbolsfoundon the device The descriptions of the following symbols are based on information provided in the following documents IEC 60601 1 Standard Medical Electrical Equipment Part 1...

Страница 15: ...ection to the mains IPX1 Protection against ingress of liquid Indicates that the enclosure of the device is designed to provide a specified degree of protection against harmful ingress of water or liq...

Страница 16: ...Bar code reader connection RS232 connection RS232 connection with power to one pin Pressure cuff connection Engraved centrifuge locking knob Flow indicator lights Symbolsfoundon disposable packaging...

Страница 17: ...o Ethylene Oxide Sterilized by exposure to Gamma irradiation Fluid path STERILE by exposure to Gamma irradiation DO NOT REUSE Caution consult operator manual for instructions Storage conditions humidi...

Страница 18: ...thetic mixture with air or with oxygen or nitrous oxide The shipping storage temp are 20C to 50C at 8 to 80 humidity The artwork for the carton is only in the old film style Characteristics Values Ca...

Страница 19: ...tion about Haemonetics approved devices such as a printer or an exter nal network that can be connected to the MCS device Note The MCS device contains no user serviceable repairable parts Caution The...

Страница 20: ......

Страница 21: ...ENTRIFUGE SYSTEM 1 2 CENTRIFUGE BASE 1 3 Using a mechanical centrifuge chuck 1 3 Using a vacuum centrifuge chuck 1 4 Applications for a centrifuge chuck adapter 1 5 CENTRIFUGE WELL 1 6 SYSTEM SEALING...

Страница 22: ...secure the disposable bowl in place during operation the other uses a vacuum effect for the same purpose The MCS centrifuge components consist of The centrifuge base The centrifuge well The system se...

Страница 23: ...origin Using a mechanical centrifuge chuck If the MCS device contains a mechanical chuck the clips on the centrifuge base will hold the bowl in place When installing a bowl the operator should exert...

Страница 24: ...e centrifuge lid To remove a bowl at the end of a procedure the operator should simply pull upward on the bowl until the vacuum force is disrupted The bowl can then be lifted out of the centrifuge wel...

Страница 25: ...f centrifuge chuck Once the adapter has been securely positioned the BMB can be installed in the adapter using a downward pressure to fully seat the bowl A suction force will be created between the ba...

Страница 26: ...h respective MCS protocol manual Figure 1 7 MCS optical bowl sensor and fluid detectors Caution The optical bowl sensor must be kept clean and should be cleared after any spills A dirty or clouded len...

Страница 27: ...d provide a seal around the stationary head of the disposable bowl The split halves of the lid are made from a durable transparent material allowing the operator to observe changes in the bowl content...

Страница 28: ...symbol on the base to place it in the locked or unlocked position Figure 1 9 Locking knob PUSH TO OPEN symbol version Figure 1 10 Locking knob PUSH TO OPEN text version Warning The MCS device is equip...

Страница 29: ...huck adapter Vacuum force secures the bowl or chuck adapter Mechanical clips secure the bowl or chuck adapter Fluid detector s One long or two round One round One round Optical bowl sensor One One One...

Страница 30: ......

Страница 31: ...Air detectors front panel 2 10 Disposable set element holders 2 11 SIDE PANELS COMPONENTS 2 12 Solution bag poles 2 2 12 Donor flow indicator lights 2 12 Anticoagulant AC drip monitor 2 13 Power entry...

Страница 32: ...tinctions The disposable elements will be explained in greater detail in Chapter 4 and in each respective MCS protocol manual As an explanation for the operator concerning any references made to dispo...

Страница 33: ...ed valve N 3 is consistently used as the donor valve During the different modes of the selected MCS protocol the valves will operate automatically opening and closing depending on the passage of fluid...

Страница 34: ...line tubing The AC pump housing is designed to secure the corresponding single pump manifold of the disposable set Dual pump assembly Blood pump and Transfer pump The Blood pump designated by the col...

Страница 35: ...filter of the disposable set and into the centrifuge bowl The Transfer pump will be active during certain protocols The Transfer pump speed will vary in relation to the Blood pump speed and the donor...

Страница 36: ...n grams the contents of the collection container s placed on the weigher arm When the Draw key is pressed to begin a procedure the weigher will automati cally tare or set the weigher to zero Thus the...

Страница 37: ...n using a bar graph The bar graph is visible on the screen when donor pressure is adequate to maintain the programmed pump speed The bar graph will not be visible if donor line pressure is below what...

Страница 38: ...so consult Chapter 6 for information about avoiding flow restrictions System Pressure Monitor SPM The SPM located on the right side of the MCS top deck measures pressure in the effluent tubing This me...

Страница 39: ...D This air detector will serve a dual purpose to the operator It is located on the top deck of the MCS cabinet to the right of the Blood pump The BLAD will remain active throughout the entire procedur...

Страница 40: ...e blood and alert the operator if any air has been introduced into the system During RETURN the DLAD will monitor the donor line as it carries blood components to be infused to the donor The DLAD moni...

Страница 41: ...ycle only after any air bubbles have been re moved Warning If after attempting this procedure to remove any air the DLAD1 and or DLAD2 detect air again the operator should terminate the procedure dis...

Страница 42: ...each of the MCS side panels A third set is located on the MCS control panel on interior of the MCS cabinet cover A fourth set is found on the exterior of the MCS cabinet cover DRAW mode The GREEN LIGH...

Страница 43: ...sses from the AC drip chamber into the AC tubing If the AC drip monitor detects a problem with the AC flow the MCS pumps will stop The operator will receive an explanatory screen message as well as an...

Страница 44: ...th an external power source via the power input receptacle located on the power entry module on the left side panel Bar code reader The bar code reader is mounted on the left panel of the MCS device a...

Страница 45: ...ed using the operating instructions provided on the MCS protocol card Prior to powering on the device the protocol card should be inserted into the card port located on the lower right side of the MCS...

Страница 46: ...xternal transfers data via a serial connection from the MCS device to an external device such as a printer or to HaemoNet the Haemonetics communication network A Haemonetics trained technician must co...

Страница 47: ...tic cover allows the transmission of procedure data to a wireless access point connected to a handheld device internal PC or network the eLynx communication system or to an external computer network o...

Страница 48: ...iologically contaminated material from the centrifuge well in the rare case of a spill or leak Two biohazard waste bags are supplied with the delivery of each MCS device A bag must be attached at all...

Страница 49: ...3 2 UPPER CONTROL PANEL 3 3 Donor flow indicator lights 3 3 Display screen 3 3 Explaining the screen layout 3 4 Understanding an operating mode 3 5 Defining the screen icons 3 5 LOWER CONTROL PANEL KE...

Страница 50: ...on line assistance and troubleshoot with HELP messages Figure 3 1 MCS control panel The control panel is located on the inside of the hinged MCS cabinet cover and contains A set of flow indicator lig...

Страница 51: ...t version Note The design of the fourth set of flow indicator lights located on the exterior of the MCS cabinet cover is identical to those located on the control panel All of the lights provide the s...

Страница 52: ...he fluctuations registered in the donor line pressure read ings The lower screen area communicates data to the operator concerning the cycle in progress as well as the volume of blood processed during...

Страница 53: ...states which are part of the DRAW mode referred to as SURGE and DWELL Defining the screen icons These symbols located on the left side of the center screen area provide a picto rial representation of...

Страница 54: ...ticoagulant solution from the anticoagulant line tubing into the donor line tubing Draw key This key is used to initiate the first DRAW cycle or resume the DRAW mode of operation The DRAW mode will mo...

Страница 55: ...These keys can be used by the operator to manually change the programmed pump speed during a collection procedure Figure 3 6 MCS pump control keys Pump arrow keys These keys can be used to temporarily...

Страница 56: ...re when performing the venipuncture or during READY or DRAW mode to modify cuff pressure The cuff cannot be inflated during RETURN Figure 3 7 MCS cuff control key Programming keys Certain system opera...

Страница 57: ...d on the screen along with the currently selected value for that parameter Note This key can be used to access the Modify Parameter screen and adjust the program parameters or to scroll through the pa...

Страница 58: ...rror detection by the MCS safety system the operator can press this key to receive the HELP screen display The HELP screen will contain the most likely source of error and a list of the appropriate op...

Страница 59: ...ine section 4 6 AC line section 4 7 CENTRIFUGE BOWL 4 8 Explaining the general design of the bowl 4 8 Understanding bowl operation 4 10 Managing the bowl air inventory 4 11 HARNESS OUT TUBING AND ELEM...

Страница 60: ...escribing the MCS Disposable Collection Material P N 85213 30 Manual revision B Figure 4 1 Example of an MCS disposable set tub Figure 4 2 The MCS disposable set tub is tailored for practical installa...

Страница 61: ...l depends on The final blood components to be collected The selected MCS protocol The following general categories exist among the types of disposable set material which can be used for an MCS collect...

Страница 62: ...o sections of tubing One section leads to the DPM filter The other section contains the blood drawn into the centrifuge bowl by the Blood pump Figure 4 3 MCS needle tubing sample pouch section Pre att...

Страница 63: ...hamber The 170 m blood filter is contained in a chamber located between the needle adapter and the disposable bowl The filter will eliminate aggregates the chamber will serve as a reservoir for blood...

Страница 64: ...so that it can be secured on the dual pump housing during autoloading and operation of the MCS Blood pump It also contains specific identification information Figure 4 5 Examples of MCS pump manifold...

Страница 65: ...he closed MCS disposable sets It is also available on certain bundled and unbundled harness in sections Bacterial filter This element can be found on a closed set The 0 22 m filter can eliminate bacte...

Страница 66: ...ifuge and the outlet port should be positioned facing the right side of the centrifuge The inlet port is used for attaching the donor line disposable tubing The inlet port leads to the feed tube which...

Страница 67: ...9 P N 85213 30 Manual revision B Figure 4 6 Latham centrifuge bowl Figure 4 7 Blow molded centrifuge bowl 1 8 2 3 4 5 6 7 1 Inlet port 2 Outlet port 3 Header shield 4 Bowl seal 5 Processing chamber 6...

Страница 68: ...let port pass through the ef fluent tubing and be collected The red blood cells being the densest of the cellular components will exit the bowl last Applications for the Latham bowl During the DRAW cy...

Страница 69: ...e returned to the donor during a RETURN cycle It is important that this air return to the bowl from the collection container in order to avoid negative pressure in the bowl Figure 4 8 Latham bowl oper...

Страница 70: ...85213 30 Manual revision B Figure 4 9 Blow molded bowl operation A Filling the bowl 1 Anticoagulated whole blood 2 Air B Collecting plasma 1 Anticoagulated whole blood 2 Plasma C Returning components...

Страница 71: ...blood components can be collected in a variety of sizes and forms of bags depending on the MCS protocol requirements Plasma collection container s Plasma can be collected in either a bag or a bottle...

Страница 72: ...tain a bacteriological filter separating the spike or solution bag connector from the rest of the disposable set This filter will eliminate bacteria from entering the collection system as the operator...

Страница 73: ...ual pump manifold 6 Solution line with filter 7 Single pump manifold 8 AC line with filter 9 Pre connected needle 10 Sample pouch 11 Recirculation chamber 12 Leukocyte reduction filter 13 SPM line 5 1...

Страница 74: ...line 8 Needle connector 9 NaCl spike 1 2 4 8 7 6 5 9 3 Commonly used set elements 1 Centrifuge bowl Latham LN5810 BMB LN625B Harness in 2 Plasma collection set LN799 3 Plasma collection set LN620 4 Pl...

Страница 75: ...control panel 5 2 Pressure monitors 5 3 Air detectors 5 3 Optical sensors 5 3 Fluid detector s 5 4 Centrifuge components 5 4 Pumps 5 5 Filter screens 5 6 Bar code reader 5 6 Pressure cuff 5 6 CUSTOME...

Страница 76: ...ily Clean the exterior surfaces as well as the pressure monitors Weekly Clean the air detectors the optical sensors line sensor and optical bowl sensor the fluid detector and the inside of the centrif...

Страница 77: ...roove should be kept free of any particles such as powder residue from disposable gloves since this could lead to an erroneous detection of air Note If a procedure is interrupted due to an air detecto...

Страница 78: ...omponents Except for the optical sensor and fluid detector s the other centrifuge compo nents can be wiped routinely using the cleaning solution and a lint free cloth This includes the centrifuge well...

Страница 79: ...ge cur rent control after any major fluid spill involving the MCS device Leakage cur rent represents a primary indication of electrical shock hazard and should be checked according to guidelines as de...

Страница 80: ...anel ensuring that all openings are com pletely covered by the filter Replace the retainer plates and tighten the screws Warning To avoid electrical shock the filter screen should be completely dry be...

Страница 81: ...Maintaining the MCS Equipment 5 7 P N 85213 30 Manual revision B...

Страница 82: ...ch respects the highest established standards of quality in design and manufacturing If for any reason merchandise must be returned to the company the customer should refer to the Haemonetics Returned...

Страница 83: ...s pertaining to the disposal of biologically contaminated material Warning Haemonetics products must be properly cleaned and packed prior to their return It remains an important responsibility of the...

Страница 84: ...med Reviewed by Date and supervisor initials Action Jan Feb March April May June July Aug Sept Oct Nov Dec Clean cabinet and control panel Clean air detectors Clean optical line sensor Clean DPM and S...

Страница 85: ......

Страница 86: ...5 12 Maintaining the MCS Equipment P N 85213 30 Manual revision B...

Страница 87: ...S DURING AN MCS PROCEDURE 6 3 Understanding the risk of hemolysis 6 3 Avoiding the consequences of flow restriction 6 3 Avoiding bowl misalignment 6 4 Avoiding overheating due to mechanical situations...

Страница 88: ...should be within 8 to 80 rh and 20 C to 50 C The recommended temperature for the working environment is between 18 C to 27 C Inspecting the material Prior to installation the operator should complete...

Страница 89: ...larms during MCS operation If there is any suspicion that hemolysis has occurred the operator should not return the contents of the bowl to the donor The local Haemonetics representa tive should be in...

Страница 90: ...Overheating could also result from a mechanical or maintenance related problem such as a defective bearing or seal within the centrifuge well In this case the operator should contact the local Haemon...

Страница 91: ...ut a tool could result in an electrical shock to the operator and or donor patient Equipment in which protection against electric shock relies on basic insulation only should not be used with the MCS...

Страница 92: ...ce Communicable disease precautions Despite testing and screening to detect communicable diseases such as hepatitis syphilis or HIV the risk remains that the blood being processed may be infected The...

Страница 93: ...ocedure UNDERSTANDING A NOTICE AND RELEVANT HELP MESSAGE 7 2 PERFORMING A RECOVERY PROCEDURE 7 3 APPLYING SPECIFIC TROUBLESHOOTING TECHNIQUES 7 4 Power failure procedure 7 4 Manual gravity infusion pr...

Страница 94: ...ative who will provide further instruction For other system alerts the operator will receive a screen message and hear an intermittent alarm The operator can use troubleshooting techniques provided on...

Страница 95: ...Procedure Recovery Screen refer to message 375 If the donor patient has remain connected to the system and the disposable set has remained fully installed the operator can resume the procedure simply...

Страница 96: ...edure If power is restored and the original venipuncture has been maintained open for blood to flow freely the operator can re install the tubing in the valves and attempt to recover the procedure and...

Страница 97: ...der to avoid pinching or tearing the tubing Remove the tubing from the DLAD1 DLAD2 and the tubing guide Removing the bowl beginning re infusion Unlock the centrifuge and open the lid Remove the dispos...

Страница 98: ...e to prevent contamination Caution At this point the operator should remove the pressure cuff from the do nor and appropriately treat the vein if infiltrated Prepare and perform a new venipuncture sec...

Страница 99: ...the target collection product volume has been reached If the AC solution bag is empty the operator will hear an alarm and receive the screen message AIR DETECTED BY THE ACAD Warning Haemonetics recomm...

Страница 100: ......

Страница 101: ...ct 8 2 Calculating the AC volume infused to the donor patient 8 4 Estimating total blood volume 8 4 Estimating the expected extra corporeal volume 8 4 Determining final product volume s 8 5 Calculatin...

Страница 102: ...g administered to the donor line tubing as whole blood is being drawn from the donor The donor hematocrit is determined prior to the collection procedure at the time of donor blood screening The follo...

Страница 103: ...2 13 7 12 5 11 5 8 7 32 17 4 15 5 14 0 12 8 11 8 8 9 34 17 8 15 9 14 4 13 2 12 1 9 2 36 18 2 16 3 14 8 13 5 12 4 9 4 37 18 5 16 6 15 0 13 7 12 6 9 6 38 18 7 16 8 15 2 13 9 12 8 9 7 39 19 0 17 0 15 4...

Страница 104: ...or patient according to the method provided by the AABB Technical Manual 13th edition appendix 5 page 757 The equations used by the MCS device are as follows For males For females Estimating the expec...

Страница 105: ...ide the operator with detailed product volume information To manually determine the collection product volume the operator should Weigh the final product on a calibrated scale Subtract the weight of t...

Страница 106: ...a post count are available the average of the pre and post counts can be used When a post collection platelet count is not available and only a pre collection platelet count is available this value c...

Страница 107: ...requirements Therefore non ap proved accessories and cables must not be used In addition the Haemonetics device and accessories must not be placed directly adjacent to or top of other equipment unles...

Страница 108: ...at of a typi cal commercial or hospital environment Voltage dips short interrup tions voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycles 40 UT 60 dip in UT...

Страница 109: ...in each frequency rangeb Interference may occur in the vicin ity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines...

Страница 110: ...e Non live supporting equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5GHz 0 01 0 12...

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