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3-8

Disposables

P/N 39551-00, Rev. F

ARNESS

OMPONENTS

Elements of the
Harness

The elements of the harness used depend upon the component to be collected.
Some of the typical elements of a set are described below.

Pre-attached Needle

This needle prevents contamination from external sources that could occur be-
fore the needle and the needle adapter are connected.

Warning!

If the needle is disconnected from the harness at

any time during collection, the storage life of the platelet prod-
uct is reduced to 24 hours.

Figure 3-6, A Typical Disposable Set (LN 994 shown)

Needle

SPM Luer

Presample

Injection

Connector

DPM Luer

Connector

Port

Platelet Bags

Pouch

Bacterial

Barrier Filter

Plasma Bag

Air Bag

Bowl

Spike

Pump Cartridge

Blood Filter

Saline

Spike

Summary of Contents for MCS+

Page 1: ...s MCS Device LN 9000 Operator and Maintenance Manual Printed in U S A 1995 Haemonetics Corporation 400 Wood Road Braintree Massachusetts 02184 781 848 7100 All Rights Reserved June 2001 Part No 39551...

Page 2: ...P N 39551 00 Rev F...

Page 3: ...otocols and therapeutic procedures Refer to Chapter 2 System Description for the machine symbol chart Caution Federal USA law restricts this device to sale by or on the order of a physician WARNING Th...

Page 4: ...n Customer Service or contact your local sales representative The uses to which the Haemonetics products may be applied and the results obtained therefrom shall be the sole responsibility of the Buyer...

Page 5: ...Belgium 1930 ZAVENTEM Telephone 32 2 7207484 Fax 32 2 7207155 France Haemonetics France SARL 46 bis rue Pierre Curie Z 1 Les Gatines France 78370 PLAISIR Telephone 33 1 30 81 41 41 Fax 33 1 30 54 29...

Page 6: ...2 20 Netherlands Haemonetics Nederland S A Zuidergracht 12 Netherlands 3763 LV SOEST Telephone 31 35 602 3425 Fax 31 35 602 4198 Scandinavia Haemonetics Scandinavia AB Ekholmsvagen 36 P O Box 183 Swed...

Page 7: ...NTROL PANEL 2 11 KEYS 2 12 Mode Keys 2 12 Pump Keys 2 13 Cuff Key 2 14 Programming Keys 2 14 PROTOCOL CARD 2 15 Protocol Card Pouch 2 17 VALVES 2 17 PRESSURE MONITORS 2 17 Donor Pressure Monitor DPM 2...

Page 8: ...3 3 Latham Bowl 3 3 The Latham Bowl Surge Process 3 5 The Role of the White Pump 3 7 HARNESS COMPONENTS 3 8 Elements of the Harness 3 8 Other Disposable Set Elements 3 11 CHAPTER FOUR SAFETY AND DONO...

Page 9: ...Cleaning the DPM and SPM 6 11 Leakage Current 6 12 FIELD SERVICE 6 12 CLINICAL SERVICES 6 12 Installation and Training 6 12 Hot Line 6 12 RETURNED GOODS AUTHORIZATION RGA SYSTEM 6 13 RGA Procedure 6 1...

Page 10: ......

Page 11: ...P N 39551 00 Rev F Chapter One INTRODUCTION OVERVIEW OF THE MCS DEVICE 1 2...

Page 12: ...1 collects blood components including platelets and plasma The MCS Device combines advanced technology with portability and ease of use The system is lightweight and compact A removable program card c...

Page 13: ...which is an integral part of the com puter control The HaemoCalculator allows the operator to input donor or patient information to optimize the blood component collection pro cess The HaemoUpdate fun...

Page 14: ......

Page 15: ...LVES 2 17 PRESSURE MONITORS 2 17 Donor Pressure Monitor DPM 2 17 System Pressure Monitor SPM 2 19 WEIGHER 2 19 AIR DETECTORS 2 19 Anticoagulant Line Air Detector ACAD 2 19 Blood Line Air Detector BLAD...

Page 16: ...2 2 System Description P N 39551 00 Rev F SPECIFICATIONS 2 28 Dimensions approximate 2 28 Weight 2 28 Power Requirements 2 28 Machine Symbol Chart 2 28...

Page 17: ...two pressure monitors that check the pressure in the disposable set On the left side of the cabinet is an anticoagulant drip monitor which monitors the flow of anticoagulant On the right side of the...

Page 18: ...onent s are collected POWER ENTRY MODULE The Power Entry Module located on the left side of the machine performs three functions a ON OFF The first function is to power the machine on and off In case...

Page 19: ...hts the Display Screen and the Control Panel DONOR PATIENT FLOW INDICATORS Donor Flow Lights During Draw the Donor Flow Lights Figure 2 4 located on both sides of the deck and on the cover indicate th...

Page 20: ...sure is measured and com municated to the MCS device computer by the Donor Pressure Monitor DPM LOW FLOW The yellow Donor Flow Lights are illuminated to indicate that the donor patient flow rate is be...

Page 21: ...de of the Single Donor Platelets protocol All data on the display is continually updated The level of the dark area on the DPM image rises and falls with the pressure sensed at the Donor Pressure Mon...

Page 22: ...or HELP to return to the Main Display SDPS HAEMOCALCULATOR Cycle 0 0 Platelet Volume 0 Volume Processed MODIFY selects to change SAVE to save values Height Weight Blood Volume HCT 5 ft 5 4182 40 Sex F...

Page 23: ...or the current procedure ends at which time the system reverts to the default parameters Repeat this process each time you wish to mod ify the parameters Note Pressing the mode control key DRAW RETURN...

Page 24: ...l Software Version E or later have re vised notice messages and associated message numbers Refer to Appendix C of the Platelet Protocol Manual Part Number 51052 00 for details Help Each notice message...

Page 25: ...NO to Mute the Alarm ANTICOAGULANT AIR DETECTOR Press HELP for the HaemoUpdate display Protocol Hints Current Action 1 Check tubing installation in ACAD 2 If air is present turn AC pump CLOCKWISE to...

Page 26: ...returns the remaining components to the donor patient To initiate an earlier Return press the RETURN key Warning Press RETURN if the donor patient exhibits signs of discomfort such as light headedness...

Page 27: ...Blood and Anticoagulant Pumps if they are turning and then restarts the pumps after they have been stopped This key temporarily stops the machine processing In the platelet protocols the White Pump ma...

Page 28: ...tient flow indicator lights Wait until the pump speed is at a constant rate before readjusting pump speed to donor patient flow Cuff Key Figure 2 8 Cuff Key During all procedures a Tourniquet Cuff pla...

Page 29: ...HAEMOCALCULATOR key is used to obtain additional information In normal operation pressing HELP HAEMOCALCULATOR once results in the display of the full procedure statistics of the HaemoUpdate screen Pr...

Page 30: ...in Protocol Port To install the Protocol Card ensure that the MCS device is powered off Open the Protocol Card door and insert the Protocol Card with the label facing toward the front of the MCS devi...

Page 31: ...ation of any of the valves unless the pumps are stopped or the machine is in the Ready mode This occurs if the pumps are temporarily stopped or if the red STOP key on the control panel has been presse...

Page 32: ...ry Procedure in Chapter 5 Return Mode During Return the DPM monitors the pressure within the donor patient line The bar graph on the display screen indicates a range of pressure from 0 at the bottom t...

Page 33: ...s using 1 026 grams milliliter as the conversion factor The Weigher automatically compensates for the weight of the bag when DRAW is first pressed in the collection protocols Note For optimal accuracy...

Page 34: ...ed the DLAD 1 stops the pumps sounds an audible alarm and displays a mes sage The DLAD 1 is monitored by the MCS device safety system This provides an extra level of safety in the unlikely event of a...

Page 35: ...des for each procedure are defined within each protocol section White Pump The White Pump pulls plasma from the plasma bag of the disposable set and pumps it into the bowl helping to maintain critical...

Page 36: ...lasma bag and the red cells from the bowl mix at the manifold between the bowl and the pumps and then are pumped to the donor patient through the Blood Pump Anticoagulant Pump The Anticoagulant Pump t...

Page 37: ...l centrifuge cover latch mechanism only requires a one quarter turn and a downward push to unlock the cover halves The mechanical centri fuge also features six mechanical clips on the centrifuge chuck...

Page 38: ...bowl damage will occur and the procedure must be discontinued Do not attempt to reseat the bowl or continue the procedure Do not return the contents of the bowl to the donor Contact Haemonetics Techni...

Page 39: ...e firmly installed and evenly seat ed in the centrifuge chuck If the centrifuge chuck spins with the bowl base not evenly seated as indicated by bowl wobbling or noise bowl damage will occur and the p...

Page 40: ...sor in the Centrifuge Well is aimed at the core of the bowl As var ious components pass between the sensor and the core the sensor measures the optical reflection from the blood in the bowl The bowl O...

Page 41: ...SORIES Each item described below is available for purchase please consult a published price list or your Haemonetics Sales Representative for additional information For protection and convenience a tr...

Page 42: ...t at the factory for the destination country Outlet must be properly grounded Operating frequency 47 63 Hz Input fusing rating 5 0 amperes domestic F2 5 amperes international Main power cable detachab...

Page 43: ...ditions should be within the following range 8 80 rh 20 C 50 C Warning Requirements for working environment Ambient temperature 10 C to 27 C Relative humidity rate maximum 95 noncondensing There is an...

Page 44: ......

Page 45: ...3 2 DISPOSABLE SET STORAGE AND HANDLING 3 2 INSPECTION 3 2 INSTALLATION 3 2 BOWLS 3 3 Latham Bowl 3 3 The Latham Bowl Surge Process 3 5 The Role of the White Pump 3 7 HARNESS COMPONENTS 3 8 Elements o...

Page 46: ...ocedures dictated by your medical facility s Exposure Control Plan as le gally required by the OSHA Bloodborne Pathogen Standard The expiration date of the disposable set is noted on the package cover...

Page 47: ...ntor of the original Haemonetics centrifugal processing chamber Allen Latham Jr the founder of Haemonetics Corporation Latham Bowl How the Latham Bowl Works The bowl consists of two parts 1 a stationa...

Page 48: ...his point because of the presence of centrifugal forces generated by the spinning bowl the fluid mi grates to the outer periphery of the bowl During this process sterile air in the bowl is displaced i...

Page 49: ...e bowl and is collected into a collection bag The Latham Bowl Surge Process The Surge process is used in platelet collection protocols Each cycle of the platelet protocols consists of a Draw and Retur...

Page 50: ...vier cells remain in the bowl Once collection is completed the bowl stops spinning Due to the loss of cen trifugal force the blood remixes When the bowl is spinning it appears to be full However all H...

Page 51: ...gure 3 5 The Role of the White Pump In the platelet collection protocols the White Pump pulls plasma from the plas ma bag of the disposable set and pumps it into the bowl located within the Cen trifug...

Page 52: ...ernal sources that could occur be fore the needle and the needle adapter are connected Warning If the needle is disconnected from the harness at any time during collection the storage life of the plat...

Page 53: ...of the fluid to the disposable from passing from the fluid container into the MCS device disposable set The flow of the fluid is not re stricted Note This filter allows the attachment of the AC or sal...

Page 54: ...ncentration of 2600 x 106 platelets per ml Plate let disposable sets without the designation CPP contain CLX platelet storage bags A platelet bag made of CLX material can store up to 3 5 x 1011 platel...

Page 55: ...ets for protocols that do not require extended dating may include other elements and may not include the previously listed elements Additional details about the disposable sets are included in the pro...

Page 56: ......

Page 57: ...R PATIENT CARE PRECAUTIONS SAFETY PRECAUTIONS 4 2 Storage and Handling of Disposables 4 2 Flammable Locations 4 2 Electrical Shock Hazards 4 2 Rotating Machinery 4 3 Communicable Disease 4 3 Restricti...

Page 58: ...t hands or gloves contacting the plastic surface are clean and dry Flammable Locations The MCS device is intended to be used in locations that are free of flammable gases and vapors Warning The MCS de...

Page 59: ...the application of all available tests to screen for communicable diseas es such as hepatitis HIV or syphilis there is always the risk that the blood being processed is infected Treat all blood as tho...

Page 60: ...harness set on the machine a careful recheck of the loaded disposable set should be completed to make certain that each section is in the correct position on the machine and that all tubing is free of...

Page 61: ...apter Five NOTICE MESSAGES AND TROUBLESHOOTING PROCESS MESSAGES 5 2 INTERLOCK MESSAGES 5 2 NOTICE MESSAGES 5 3 RECOVERY PROCEDURE 5 5 REPEAT VENIPUNCTURE 5 5 GRAVITY REINFUSION PROCEDURE 5 7 TABLE 5 1...

Page 62: ...Note in the above display that the current mode is indicated PRIMING the current state of the machine is shown PUMPS STOPPED the donor pressure is displayed on the bar graph and the next step for the...

Page 63: ...e integrity of both the ma chine and the disposable NOTICE MESSAGES Notice messages may be initiated by one of two systems that are monitoring the MCS device at all times during operation Generally no...

Page 64: ...rst action of the MCS device is to test its own components and ensure that the correct disposable set has been installed properly Failure of the self test halts the test sequence Should this occur rec...

Page 65: ...e installation the procedure may be resumed by pressing the RETURN key The MCS device will now resume the procedure by returning the contents of the bowl and any additional plasma to the donor or pati...

Page 66: ...ble Note This method utilizes an open system and may reduce the storage of col lected products to 24 hours depending on the product collected Method B Using a Sterile Connection Device a Using a steri...

Page 67: ...machine To retrieve the information press HELP at the Install Disposable screen for procedure statistics Note To maintain 5 day storage of platelet products the platelet product must be hermetically s...

Page 68: ...tubing installation in DLAD2 2 If air has traveled past DLAD1 or DLAD2 open the RED valve and turn the BLOOD pump CLOCKWISE to move air into the bowl 3 Resume operation after air is cleared from tubi...

Page 69: ...entrifuge has stopped 2 Check that bowl is installed properly 3 Check Centrifuge for obstructions 4 Resume operation NOTE If problem persists call Haemonetics Technical Hot Line 32 thru 36 SYSTEM PROB...

Page 70: ...operation 46 PUMP PROBLEM WHITE PUMP WAS TURNING TOO FAST A restriction may have occurred 1 Check pump for restrictions 2 Check pump for kinked tubing 3 Resume operation 48 PUMP PROBLEM AC PUMP WAS T...

Page 71: ...ists call Haemonetics Technical Hot Line 62 ECV LIMIT THE DONOR ECV LIMIT IS REACHED The allowed Extracorporeal Volume ECV limit was reached A complete Return cycle must be performed 1 Press RETURN to...

Page 72: ...installation at AC Pump 3 Power off and complete a Procedure Recovery NOTE If problem persists call Haemonetics Technical Hot Line 71 SYSTEM PROBLEM THE SAFETY SYSTEM HAS ENCOUNTERED AN ERROR A pump...

Page 73: ...mps 4 Check Drip Chamber installation 5 Check Drip Chamber fluid level 6 Resume operation 104 NO AC FLOW HIGH AC FLOW DETECTED BY DRIP MONITOR 1 Check tubing at AC Pump 2 Check Drip Chamber installati...

Page 74: ...ical Hot Line 228 VALVE PROBLEM THE WHITE VALVE WAS DETECTED OUT OF POSITION 1 Toggle the valve manually 2 Resume operation NOTE If problem persists call Haemonetics Technical Hot Line 229 VALVE PROBL...

Page 75: ...wet 260 PRESSURE PROBLEM THE SPM PRESSURE WAS TOO LOW The SPM low pressure limit was exceeded 1 Check tubing for occlusions 2 Check tubing for closed clamps 3 Check tubing at valves 4 Check that produ...

Page 76: ...dry 4 Resume operation 344 SYSTEM PROBLEM NO PRESSURE CHANGE DETECTED AT THE SPM 1 Check the SPM tubing for occlusions 2 Check the SPM tubing for clamps 3 Ensure the SPM filter is dry 4 Resume operati...

Page 77: ...installation in ACAD 2 If air is present turn AC pump CLOCKWISE to move air past ACAD 3 Call Haemonetics Technical Service if problem persists 4 Resume operation after air is cleared from ACAD 376 BLA...

Page 78: ...LEM THE WEIGHT OF THE BAGS ON THE WEIGHER CHANGED An unexpected weight change occurred Do NOT touch the Weigher during operation 1 Check that the bag hangs free 2 Check tubing at valves 3 Resume opera...

Page 79: ...to donor or 2 Press NO to continue to draw from Buffy Bag 399 PROCESS PROBLEM IS THE BUFFY BAG EMPTY Air has been detected at the BLAD but the Buffy Bag should be empty 1 Press YES to confirm and swi...

Page 80: ...ists call Haemonetics Technical Hot Line 413 VALVE PROBLEM PURPLE VALVE SELF TEST FAILED 1 Toggle the valve manually 2 Turn power OFF then ON and try again NOTE If problem persists call Haemonetics Te...

Page 81: ...esume operation 424 SELF TEST PROBLEM PLEASE CLAMP THE SPM LINE AND REMOVE FILTER During self test the DPM and SPM filters can not be installed 1 Clamp tubing to the appropriate filter 2 Remove filter...

Page 82: ...onnection 3 Turn power OFF then ON and try again NOTE If problem persists call Haemonetics Technical Hot Line 433 434 SELF TEST PROBLEM THE SAFETY SYSTEM FAILED THE SELF TEST 1 Turn power OFF then ON...

Page 83: ...and try again NOTE If problem persists call Haemonetics Technical Hot Line 449 452 453 SELF TEST PROBLEM THE SAFETY SYSTEM FAILED THE SELF TEST 1 Turn power OFF then ON and try again NOTE If problem p...

Page 84: ...F FROM REAR PANEL Excessive Cuff pressure was measured 1 Disconnect cuff from rear panel 2 Deflate cuff completely 3 Connect cuff to rear panel 4 Resume operation 468 SELF TEST PROBLEM IS LINE SENSOR...

Page 85: ...and contact Haemonetics Technical Hot Line SOFTWARE WATCHDOG ID TIMEOUT The computer has sensed a Software Watchdog ID timeout Please turn the power off and contact Haemonetics Technical Hot Line SOFT...

Page 86: ......

Page 87: ...lood White and Anticoagulant Pumps 6 9 Cleaning the Control Panel 6 9 Cleaning the Air Detectors 6 10 Cleaning the Air Filter 6 10 Cleaning the Exterior Surfaces and User Panel 6 11 Cleaning the DPM a...

Page 88: ...ntri fuge If grease has been applied to the mechanical chuck con tact Haemonetics Field Service immediately MAINTENANCE AND CLEANING Normal maintenance of the MCS device consists only of seeing that s...

Page 89: ...A Bloodborne Pathogen Standard Centrifuge Maintenance There are two different types of centrifuge used in the MCS Systems The cen trifuge that is installed in your MCS System may utilize a mechanical...

Page 90: ...cs the operator should rinse the lens with clear water and dry it so that the lens is not clouded Mechanical Centrifuge Well and Cover The Centrifuge Well and Cover should be cleaned monthly as well a...

Page 91: ...uge Drain Tube a plastic tube exiting the base of the machine and that it hangs freely at the back of the machine 2 Wipe away as much fluid blood as possible with gauze pads Spray cleaning solution fo...

Page 92: ...e proper cleaning and to eliminate harm to machine components Note Two biohazard waste bags are included with each MCS device The bags are located under the machine on a tray One of the bags is connec...

Page 93: ...ll amount of silicone grease onto the ring with a finger ensuring an even amount around the ring To clean a fluid spill 1 Power off the machine and disconnect the power cord from the outlet En sure th...

Page 94: ...and clear A dirty or clouded lens could in terfere with proper operation of the sensor Always clean the optical lens after a blood spill Cleaning the Line Sensor Line Sensor The line sensor should be...

Page 95: ...ny debris on the Roller Assembly Ensure that all the rollers turn freely on the Roller Assembly 4 Rinse with clear water to rinse away the cleaning solution 5 Dry the assembly with a lint free towel 6...

Page 96: ...e and easy The following steps outline the correct procedure Note There are two types of machine stands requiring two methods of filter access for cleaning Stand A is a black metal stand with one cent...

Page 97: ...onthly 1 Wipe the exterior surfaces and user panel with a lint free cloth moistened with water 2 Dry with a lint free cloth Cleaning the DPM and SPM The DPM and SPM should be cleaned daily 1 Push whit...

Page 98: ...enance and quality control Maintenance contracts are available to ensure that your Hae monetics instrument continues to function well In the continental U S Field Service may be reached by calling 800...

Page 99: ...ation a Product list number b Product lot number and outdate c The quantity to be returned d The defect noted e The number of cartons being returned 3 The coordinator will inform you of the additional...

Page 100: ...owl optics lens Monthly and with a spill Clean disposable ID window Monthly Clean pumps Monthly and with a spill Clean exterior surfaces and user panel Monthly and with a spill Clean air detectors Mon...

Page 101: ...537 2802 to assist in determining the appropriate maintenance schedule Name of person performing preventive maintenance Date of preventive maintenance Reviewed by Date Initial Action Jan Feb Mar Apr M...

Page 102: ......

Page 103: ...duct 7 2 AC Volume Returned to the Donor or Patient 7 3 Total Blood Volume Calculations 7 4 Expected Extracorporeal Volume 7 7 Determining Product Volume 7 8 Calculating Platelet Yields 7 8 Calculatin...

Page 104: ...at ed by multiplying the concentration of anticoagulant in the plasma by the volume of the product Table 7 1 Concentration of anticoagulant in plasma or platelet products AC Ratio 1 8 1 9 1 10 1 11 1...

Page 105: ...of anticoagulant infused equals AC used AC in product 42 19 8 17 7 16 1 14 7 13 6 10 3 43 20 0 18 0 16 3 14 9 13 8 10 5 44 20 3 18 2 16 6 15 2 14 0 10 6 45 20 6 18 5 16 8 15 4 14 2 10 8 46 20 9 18 8...

Page 106: ...he donor or patient on the Y Height axis 3 Select the weight of the donor in pounds on the top X Weight axis 4 Find the point in the chart where the Height and Weight intersect 5 Follow the curved blo...

Page 107: ...dy Weight lb Estimated Blood Volume ml Chart 7 1 Estimated Blood Volume for Males Utilizing N dler Equation 3600 3800 4000 4200 4400 4600 4800 5000 5200 5400 5600 5800 8000 6800 6600 6400 6200 6000 74...

Page 108: ...quation Estimated Blood Volume ml 5000 4800 4600 4400 4200 4000 3800 3600 3400 3200 3000 76777 6600 6600 6800 7000 6400 6200 6000 5800 5600 5400 5200 8 0 6 0 5 8 5 4 5 0 4 8 4 4 4 0 6 4 6 8 7 0 7 4 7...

Page 109: ...ood cells is the total volume of red cells expected to be in the disposable at the start of the return mode The maximum volume of red cells in the LN 994 disposable does not exceed 190 ml Note These v...

Page 110: ...g ml The Procedure Complete Screen and HaemoUpdate Screen give de tailed product volume information To manually determine the collected product volume weigh the total product on a calibrated scale an...

Page 111: ...the aver age of the pre and post counts If only a pre count is available use the pre count 2 Determine the net volume of donor blood processed by subtracting the vol ume of anticoagulant used from th...

Page 112: ...ently used concentration of citrate is 4 citrate at a 1 16 anticoagulant ratio To make a known citrate concentration Citrate mix 46 7 14g citrate 30ml Trisodium Citrate with the Saline ACD A or ACD B...

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