Haemonetics Cell Saver 5+ Operation Manual Download | Manualshive

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P/N 53063-30, Manual revision: B

iv

Preface

Contacting Haemonetics worldwide

The operator should consult the following alphabetical list containing all
international branch addresses when contacting the appropriate Haemon-
etics representative for each locality.

Haemonetics Asia Inc.

Taiwan Branch
26F-1, No. 102 Roosevelt Road Sec. 2
Taipei, Taiwan
Tel. [+886 2] 2369 0722
Fax [+886 2] 2364 3698

Haemonetics

Handelsges.m.b.H.
Berlagasse 45/B2-02
1210 Wien, Austria
Tel. [+43 1] 294 29 00
Fax [+43 1] 294 29 05

Haemonetics Belgium NV

Leuvensesteenweg 542-BP. 14
Planet II Complex
1930 Zaventem, Belgium
Tel. [+32 2] 720 7484
Fax [+32 2] 720 7155

Haemonetics BV

Tinstraat 107
4823 AA Breda
The Netherlands
Tel. [+31 76] 544 9477
Fax [+31 76] 544 9357

Haemonetics Medical Devices
(Shanghai) International
Trading Co. Ltd.

Room 28032, Shanghai HSBC Tower
101 Yin Cheng East Road
Shangai 200120, PRC
Tel. [+86 21] 5066 3366
Fax [+86 21] 6841 3688

Haemonetics CZ, spol. s r.o.

Pta

š

ínského 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] 30 81 41 30

Haemonetics GmbH

Rohrauerstrasse 72
81477 München, Germany
Tel. [+49 89] 785 8070
Fax [+49 89] 780 9779

Haemonetics Hong Kong Ltd.

Suite 1314, Two Pacific Place
88 Queensway, Hong Kong
Tel. [+852] 2868 9218
Fax [+852] 2801 4380

Haemonetics Italia S.R.L.

Via Donizetti 30
20020 Lainate (MI), Italy
Tel. [+39 2] 9357 0113
Fax [+39 2] 9357 2132

Haemonetics Japan K.K.

Kyodo Building 3F
16, Ichiban-cho, Chiyoda-ku
Tokyo, Japan, 102-0082
Tel. [+81 3] 3237 7260
Fax [+81 3] 3237 7330

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Summary of Contents for Cell Saver 5+

Page 1: ...Cell Saver 5 Autologous Blood Recovery System Operation Manual Printed in France Haemonetics Corporation 400 Wood Road Braintree MA 02184 USA P N 53063 30 Manual revision B 1993 2005 Haemonetics Corp...

Page 2: ......

Page 3: ...onetics guarantees its products when correctly 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 i...

Page 4: ...544 9477 Fax 31 76 544 9357 Haemonetics Medical Devices Shanghai International Trading Co Ltd Room 28032 Shanghai HSBC Tower 101 Yin Cheng East Road Shangai 200120 PRC Tel 86 21 5066 3366 Fax 86 21 68...

Page 5: ...d Sweden Tel 46 46 286 2320 Fax 46 46 286 2321 Haemonetics UK Ltd Beechwood House Beechwood Estate Elmete Lane Roundhay Leeds LS8 2LQ United Kingdom Tel 44 113 273 7711 Fax 44 113 273 4055 Haemonetics...

Page 6: ...r Text preceded by this bullet indicates an item on a list of information for the operator Text preceded by this bullet indicates an action for the operator Symbols found on the device IEC 60601 1 Sta...

Page 7: ...on to the mains 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 liquid into...

Page 8: ...r Contents sterile by exposure to ethylene oxide Fluid path sterile by exposure to ethylene oxide Contents sterile by exposure to gamma irradiation Fluid path sterile by exposure to gamma irradiation...

Page 9: ...on B ix Preface Fragile handle with care Bowl symbol chart During a procedure the bowl icon on screen reflects the bowl size currently in use See below for bowl sizes and corresponding icons 70 mL bow...

Page 10: ......

Page 11: ...up 1 8 Final blood product quality 1 9 Performance readouts 1 9 Data acquisition tools 1 9 Emergency mode 1 9 LISTING THE CELL SAVER 5 SPECIFICATIONS 1 10 Fluid management systems 1 11 Processing spee...

Page 12: ...bout communicable diseases 3 3 PREVENTING PROBLEMS DURING A CELL SAVER 5 PROCEDURE 3 4 Avoiding the consequences of flow restriction 3 4 Understanding the risk of hemolysis 3 4 Inspecting for twists a...

Page 13: ...THE AUTOMATIC MODE 5 2 Explaining the STANDBY state 5 2 Filling the bowl 5 3 Washing the cells 5 5 Emptying the bowl 5 6 Monitoring the waste bag 5 6 Reinfusing processed blood 5 7 Explaining the air...

Page 14: ...SAVER 5 SEQUESTERING PROTOCOL 7 2 Describing method of sequestering 7 2 INITIATING A SEQUESTERING PROCEDURE 7 3 Selecting the sequestering protocol 7 3 Setting the processing parameters 7 5 PROCESSIN...

Page 15: ...9 3 Cleaning the centrifuge well 9 3 Cleaning the fluid detectors 9 3 Cleaning the blood pump 9 3 Cleaning after a spill 9 4 Washing the air filter 9 4 PROVIDING CUSTOMER SERVICE 9 5 Field service 9...

Page 16: ......

Page 17: ...logous transfusion 1 5 Historical overview 1 6 Haemonetics Cell Saver systems 1 7 PRESENTING SPECIAL CELL SAVER 5 FEATURES 1 8 Automated operation 1 8 Computer guided setup 1 8 Final blood product qua...

Page 18: ...P N 53063 30 Manual revision B 1 2 Presenting the Cell Saver 5 System Figure 1 1 The Haemonetics Cell Saver 5...

Page 19: ...ells RBCs then washed to remove cell stroma platelets acti vated clotting factors extracellular potassium free hemoglobin anticoagu lant and cardioplegia The washed packed RBCs may then be pumped to a...

Page 20: ...earlier for reinfu sion to the patient The Haemonetics Cell Saver 5 system may also be used for pre operative plasma sequestration Contraindications for use The risk benefit ratio of blood salvage mu...

Page 21: ...atient who is receiving the transfusion Autologous versus homologous transfusion The advantages of autologous transfusion are well documented The major advantages are as follows No risk of disease tra...

Page 22: ...e donation of a small quantity of blood produced no harmful effects on the donor 4 First recorded uses of autologous transfusion In the late 1800 s an English surgeon named James Highmore proposed the...

Page 23: ...urgery 8 Klebanoff s device was introduced commercially in the 1970 s by Bentley Laboratories The device was effective though unsophisticated as blood was simply anticoagulated filtered and reinfused...

Page 24: ...ifuge well an ultrasonic air detector on the tubing line and an optical effluent line sensor provide information to the CS5 microprocessor which then regulates the cycles of the device based on this i...

Page 25: ...nsists of red blood cells suspended in saline with a hematocrit of at least 50 Performance readouts The right side of the display panel provides information relative to CS5 operation which is constant...

Page 26: ...cations for operating the CS5 device are as follows Characteristics Depth cm Height cm Width cm Device alone Pole extended 37 189 41 Pole retracted 37 86 41 Device with cart Pole extended 58 5 230 48...

Page 27: ...p of other equipment unless specifically approved by Haemonetics Fluid management systems The device is equipped with a pole for hanging the saline solution reservoir reinfusion bag anticoagulant solu...

Page 28: ...device from the cart depress the release button located to the right of the latch as illustrated in Figure 1 3 A handle will pivot outward from the left side of the latch Pull on the handle to ensure...

Page 29: ...ng stubs Sterile disposable single use only LN245 Reinfusion bag 1 liter capacity Sterile disposable single use only LN246 Waste bag 10 liter capacity Sterile disposable single use only LN261 261E Cel...

Page 30: ...td 1949 p 22 4 Blundell James Experiments on the Transfusion of Blood by the Syringe Medico chirurgical Trans 9 56 92 Feb 3 1818 5 Highmore William Overlooked Source of Blood Supply for Transfusion in...

Page 31: ...d 2 5 DESCRIBING THE CELL SAVER 5 HARDWARE ELEMENTS 2 10 Valves 2 10 Pump 2 10 Air detector 2 11 Clamped line sensor blue line sensor 2 11 Centrifuge well 2 12 Fluid detectors 2 12 Optical bowl sensor...

Page 32: ...cribing the Cell Saver 5 System Components Figure 2 1 The Cell Saver 5 components 1 Centrifuge cover 2 Centrifuge 3 Effluent line sensor 4 Power switch 5 Waste bag weigher 6 Valve and pump section 7 K...

Page 33: ...et The device components include the control panel elements and the hardware elements A cart is provided with the system for added maneuvrability and for adjusting the system to a proper working heigh...

Page 34: ...dated For example if the pump speed decreases from 600 ml min to 500 ml min the readout on the display screen will change from 600 to 500 During normal operation the display screen is segmented into t...

Page 35: ...control keys When the CS5 device is operating in the automatic mode other keys will be backlit at the appropriate times during each cycle to allow the operator to advance through the cycle or modify p...

Page 36: ...Used to resume operation from STANDBY at the point in which the process was stopped Stop Used to interrupt the process by stopping the pump and centrifuge and closing all clamp valves Mode Used to ch...

Page 37: ...protocol selection protocol setup and other various points during both automatic and manual operation Key Purpose Modify Used to activate or deactivate the other modify action keys When active the ope...

Page 38: ...ce into a spinning bowl Conc Cell Saver Sequester Used to pump fluid from the product bag into a spinning bowl Supplements Fill and is usually selected when the bowl is partially full and the reservoi...

Page 39: ...Cell Saver Used to increase the pump speed by incre ments of 25 ml min up to a maximum of 1000 ml min Sequester Used to increase the pump speed Fill increments of 10 ml min up to a maximum of 250 Emp...

Page 40: ...de the CS5 device controls the opening and closing of the valves The function of each valve is as follows Red line valve opens the pathway to the blood source usually a res ervoir or extracorporeal ci...

Page 41: ...air bubbles caused by emptying the wash solution container will advance the device to the next state usually EMPTY If the air detector senses air in the line prior to at least 90 completion of the pro...

Page 42: ...with an electronic fluid detection system designed to detect the presence of liquid The CS5 safety system will auto matically stop the centrifuge and pump if there is contact between liquid of any so...

Page 43: ...it is full In the AUTOMATIC mode the message Please empty waste bag is displayed when approximately 8 liters of fluid are in the bag for the Latham bowl sets and approximately 4 5 liters for the 70mL...

Page 44: ...blue coded tubing connected to the reinfusion bag All three color coded lines pass through the pinch valves on the device and are joined at a tubing manifold A clamped line sensor is located under th...

Page 45: ...quired The A A assembly contains a double lumen tubing which can be attached to a suction tip for aspiration from the field Blood and AC solution are drawn into the tubing by wall suction mixed and th...

Page 46: ...tion chamber where the blood is processed The stationary inner assembly contains the inlet and outlet ports Figure 2 13 The Latham bowl and subassemblies Warning It is important to verify that the out...

Page 47: ...ion of the bowl When blood is pumped into the spinning bowl through the inlet port the red blood cells are centrifuged outward toward the perimeter of the bowl The lighter lower density supernatant is...

Page 48: ...level shown Under automatic control the interface is controlled by the optical bowl sensor to produce consistently good results In general filling the bowl to a lower hematocrit will necessitate a hi...

Page 49: ...ne wash to waste bag Packed RBCs to reinfusion bag Air from waste bag Air Packed RBCs suspended in saline Supernatant Waste RBCs 1 Blood is pumped in separation begins as the bowl spins 2 The supernat...

Page 50: ......

Page 51: ...3 PREVENTING PROBLEMS DURING A CELL SAVER 5 PROCEDURE 3 4 Avoiding the consequences of flow restriction 3 4 Understanding the risk of hemolysis 3 4 Inspecting for twists and kinks in the tubing 3 5 A...

Page 52: ...chemical vapors Many plastic materials are sensitive to chemicals such as solvents refrigerants and detergents The mechanical properties of plastic material may be seriously degraded when exposed adv...

Page 53: ...m spinning if the cover is opened Warning Operators or personnel working in proximity of this equipment should respect the standard precautions applicable to all rotating machin ery Power outlet conne...

Page 54: ...t the flow of sterile air to and from the air waste bag is not prevented by either a flow restriction or an air leak Understanding the risk of hemolysis Hemolysis involves the destruction of red blood...

Page 55: ...Warning The operator must not use any bowl which cannot be properly seated in the centrifuge chuck Overheating can occur subsequently lead to hemolysis and make any blood being processed unsafe for r...

Page 56: ...Pressing the pump Pause key again will cause the pump to resume at the previous rate Caution A wash flow rate which is too low will provide a poor wash of the cell since there will be insufficient agi...

Page 57: ...ry to remove air from the reinfusion bag Clamp the tubing between the reinfusion bag and the patient and invert the reinfusion bag Unclamp one of the red clamps on the tubing to the reinfusion bag and...

Page 58: ...during each procedure without compromising the final product Any changes made to the preset processing parameters should be carefully considered prior to being executed Sequestering Typical processin...

Page 59: ...4 3 INITIATING A CELL SAVER 5 PROCEDURE 4 4 Explaining the power on procedure 4 5 Explaining the bowl type confirmation message 4 7 INSTALLING A CELL SAVER DISPOSABLE SET 4 8 Preparing the collection...

Page 60: ...lection Reservoir even if there is some doubt that the amount collected will be sufficient to warrant processing by the Cell Saver system Once the blood is collected in the reservoir it may be process...

Page 61: ...he red coded fill line where it will be returned to the bowl and eventually sent to the waste bag during the next fill cycle If this saline was left in the line it would be sent to the reinfusion bag...

Page 62: ...ion is simple Physical setup involves Installing the bowl in the centrifuge well Installing the tubing harness for the passage of fluids in and out of the system Hanging the appropriate solutions for...

Page 63: ...y message Press the Yes key to retain data collected prior to powering off the device Press the No key to initiate a new procedure At this point or if the device has been powered off for more than six...

Page 64: ...mple of a Self Test Notice message Once the CS5 system self test has been successfully completed the following information will be displayed Figure 4 4 Load Disposable screen message At this point the...

Page 65: ...stalled the following message will be displayed Figure 4 5 Bowl type confirmation message If this message should appear the operator should Press the Select key to select and highlight the correct bow...

Page 66: ...ll a collection reservoir on the IV pole and clamp the reservoir drain Open the Aspiration and Anticoagulation set using aseptic technique Pass the sterile inner wrapped line onto the sterile field an...

Page 67: ...to blood volume should range between 1 5 to 1 10 or approximately 70 ml of citrate per 500 ml of recov ered blood Reopen the roller clamp on the AC drip line to allow full flow of AC solution allowin...

Page 68: ...with the 70mL Bowl For all sets Lift the bowl out of the tub and place it in the centrifuge well Ensure that the red indicator lines inside the chuck adapter are visi ble Ensure that the lower port of...

Page 69: ...edure Figure 4 8 Securing the centrifuge bowl steps A and B Installing the tubing harness Place the valve tubing manifold in the tubing slots and thread the pump tubing around the pump Insert the tubi...

Page 70: ...pump lever Figure 4 10 Securing the tubing harness Close the fluid deck cover Installing the line sensor tubing For the Latham bowl sets Thread the effluent tubing through the effluent line sensor gr...

Page 71: ...he tubing is deeply inserted as depicted Figure 4 12 Installing the line sensor tubing 70mL Bowl set For all sets Close the centrifuge cover Hanging the bags Hang the reinfusion bag on the IV pole as...

Page 72: ...e as depicted Figure 4 14 Hanging the waste bag Verify that the waste bag is securely connected to the effluent line Ensure that the drain port is completely closed Connecting the reservoir Asepticall...

Page 73: ...e the saline bags and unclamp the lines Note Each wash cycle requires a volume of saline solution which will depend on the size of the bowl in use Latham bowl 225 ml 1000 ml saline solution Latham bow...

Page 74: ...state screen display initial The CS5 system will be ready to proceed with collection The operator should refer to the appropriate chapter for specific instructions about protocol function Chapter Fiv...

Page 75: ...n delay 5 8 DESCRIBING ADDITIONAL AUTO MODE FUNCTIONS 5 10 Using the EMERGENCY mode 5 10 Explaining the CONCENTRATE state option 5 11 Modifying certain processing parameters 5 12 Automatic saving of m...

Page 76: ...explained in Chapter Four Because of the controls and intelligence built into the CS5 device automatic processing will produce consistently good results when the solutions have been properly prepared...

Page 77: ...ed into the spinning centrifuge bowl During the first cycle only the saline line will automatically be primed before the unprocessed blood is pumped into the spinning bowl The following information wi...

Page 78: ...The CS5 system will resume filling the bowl once the preset level Resume at Level parameter has been detected in the reservoir Besides initiating the FILL state at anytime from the STANDBY state the...

Page 79: ...perator as described in the section Describing additional auto mode functions During the automatic WASH state the CS5 system will optimize the pro cess by operating at pump rates within the following...

Page 80: ...e and remove the disposable set Monitoring the waste bag During the procedure the CS5 system will monitor the amount of fluid collected in the waste bag and alert the operator to change or drain the c...

Page 81: ...MUST NOT become empty in between trans fusions to the patient If air does enter the reinfusion line it must be removed before starting reinfusion The slide clamp between the reinfusion bag and the pat...

Page 82: ...eep will be heard The following message will be displayed The operator should replace the saline bag and then press the Start key to re sume processing If 90 or more of the wash solution volume has be...

Page 83: ...perator can Press the Pause key and stop the pump The word Pause will flash on the screen display Press the Pump slew keys to gradually adjust the pump speed The operator can adjust the pump to the de...

Page 84: ...display These options will be presented in further detail in the following sections Using the EMERGENCY mode In the EMERGENCY mode the CS5 device will process blood at high speeds while in automatic o...

Page 85: ...turn whatever cells are present This is sometimes the case at the end of a procedure when the bowl is not completely full and yet no more blood loss is expected During the CONCENTRATE state the blue l...

Page 86: ...the CS5 system will automatically enter the WASH state Modifying certain processing parameters During automatic operation the operator can access certain processing pa rameters at different points in...

Page 87: ...described in this section are automatically stored from proce dure to procedure by the CS5 device This allows customized operation based on the working environment At the beginning of every procedure...

Page 88: ...the volume removed from the extracorporeal circuit The RETURN option sends the washed red blood cells through the red line the FILL line into the cardiotomy reservoir rather than through the blue line...

Page 89: ...ecre ments the reinfusion volume remains unchanged When the Pump RBCs to option is set at Red Line the bowl will automati cally be emptied through the red line towards the bypass circuit In this case...

Page 90: ...the cells as in case of an emergency situation or if the cells are being hemoconcentrated for return to the bypass circuit the physician may re quest that the operator omit the WASH state This will re...

Page 91: ...nsor option To disable the reservoir level sensor function in the STANDBY state the op erator can set the Level Sensor option to OFF By doing this only pressing the Start key will initiate the FILL st...

Page 92: ...hen this parameter is set at OFF the pump speed selected by the operator during the FILL WASH and CONC states will be used systematically for all subsequent cycles unless another bowl type is detected...

Page 93: ...er automatic control Two bowls have been processed 2000 ml of saline solution has been used during the wash cycles A total volume of 2525 ml of fluid has been processed from the reser voir 400 ml of p...

Page 94: ...e To ensure the accuracy of the volume accounting function it is important to remember the following guidelines The operating room suction must not be regulated at too high of a pressure setting Vacuu...

Page 95: ...he procedure The operator should remember to subtract this 20 ml volume from the display readout until the blue line is drained at the end of the proce dure and the 20 ml are recovered For example if...

Page 96: ...5 FILL 125 ml min 300 ml min 600 ml min WASH 100 75 ml min 300 ml min 500 ml min EMPTY 100 ml min 100 75 ml min 300 250 ml min Table 5 2 Wash volume per cycle State 70mL Bowl Latham 125 Latham 225 WAS...

Page 97: ...anual control keys 6 3 Selecting manual operation 6 4 Modifying preset processing parameters 6 4 Explaining the recentrifugation delay 6 5 Collecting fluid in the reservoir 6 6 Filling the bowl 6 6 Us...

Page 98: ...or initiates a change Warning In the MANUAL mode of operation the operator must initiate all changes and advance to each operating state using the manual control keys The optical RBC bowl sensor and t...

Page 99: ...functional at different points in the procedure depending on the current process state Figure 6 1 CS5 keypad Manual operation The operator will be able to press the Mode key at any time to return to a...

Page 100: ...isplay will appear Figure 6 4 Example of the STANDBY state screen display manual Modifying preset processing parameters The CS5 system preset processing parameters are programmed with the same default...

Page 101: ...ain or reset to the default values by the oper ator Explaining the recentrifugation delay Once the centrifuge bowl has been stopped red blood cell separation is lost This settling of cells could lead...

Page 102: ...olution Initiation of the FILL state is largely dependent upon the rate of fluid collec tion in the reservoir If the patient is losing blood steadily and rapidly processing may begin as soon as 100 ml...

Page 103: ...llows Press the Wash key to receive the following information Figure 6 7 Example of the WASH state screen display manual The volume of wash solution required will depend upon factors such as the degre...

Page 104: ...ir filling the bowl and reinfusion to the patient can occur simultaneously throughout the procedure once the first cycle of processed blood has been pumped to the reinfusion bag Important Warnings abo...

Page 105: ...l is empty The following information will be displayed Figure 6 9 Example of a STANDBY state screen display manual If the reservoir contains more blood to be processed Press the Start key to initiate...

Page 106: ...g manual operation Table 6 1 Pump rate range State 70mL Bowl Latham 125 Latham 225 FILL 125 ml min 300 ml min 600 ml min WASH 100 ml min 300 ml min 500 ml min EMPTY 100 ml min 100 ml min 300 ml min Ta...

Page 107: ...ATING A SEQUESTERING PROCEDURE 7 3 Selecting the sequestering protocol 7 3 Setting the processing parameters 7 5 PROCESSING FROM BLOOD BAGS 7 6 Filling the bowl 7 6 Emptying the bowl 7 7 Transferring...

Page 108: ...he sequestering set LN244 should be attached to the standard bowl processing set as described in this chapter or in the Directions For Use DFU provided with the set Describing method of sequestering D...

Page 109: ...any precautions and warnings specifically related to sequestering as provided in this chapter Selecting the sequestering protocol Once the disposable material has been properly installed and the CS5 d...

Page 110: ...tion to Sequester Press the Modify key to return to the STANDBY state screen The screen display will now indicate Sequester on the right side as follows Figure 7 3 Example of the STANDBY state screen...

Page 111: ...elect key to scroll the list and highlight the parameter Press the Arrow keys to adjust the value displayed on the screen Press the Modify key to return to the STANDBY state screen display Before star...

Page 112: ...wash line bag spike on the standard CS5 disposable set Clamp the unused wash line spike section Filling the bowl The operator can now begin to draw blood into the bowl from the blood bag Press the St...

Page 113: ...e PRP bag Clamp the clear line to the PPP bag When the effluent line flow from the bowl turns medium red indicating the presence of red blood cells Press the Empty key to stop both the centrifuge and...

Page 114: ...the applicable current guidelines and stan dards it is recommended that a transfusion filter capable of retaining parti cles potentially harmful to the recipient be used when returning processed red c...

Page 115: ...uestered and the volume to be sequestered must be determined by an attending physician The physician must be informed of the amount and type of anticoagulant solution used since the plasma collected w...

Page 116: ...d bank for platelet product storage and handling It is important to remember that any autologous blood product collected has been processed from a patient who might not normally have been accepted for...

Page 117: ...rator should Press the Yes key to select the Cell Saver protocol When the Yes key is pressed form the STANDBY state screen display the following information will appear Figure 7 9 Load disposable scre...

Page 118: ......

Page 119: ...UISITION FEATURES 8 4 Viewing the current procedure data 8 4 Transferring procedure data 8 5 Optionally entering certain data 8 6 EXPLAINING OFF LINE DATA ACQUISITION FEATURES 8 7 Accessing off line d...

Page 120: ...ity to retrieve the recorded information on a choice of exter nal devices printer computer system These data acquisition tools can be separated in two categories On line data acquisition features acce...

Page 121: ...he end of each complete cycle Error codes recorded during the procedure Estimated Blood Loss EBL for the patient Estimated Plasma Loss EPL for the patient These two last parameters will be displayed a...

Page 122: ...isplayed Figure 8 1 Example of the STANDBY state screen display From the STANDBY state screen display the operator can choose to view the current statistics on the View Data screen display or send the...

Page 123: ...nsfer the data to the output device connected to the CS5 device Press the Mode key to display the volume status after each cycle The following information will be displayed when the Mode key is presse...

Page 124: ...ocedure The operator can do this as follows Press the Start key when the LOAD DISPOSABLE screen display appears This action will display the following information Figure 8 4 Example of the Patient ID...

Page 125: ...n can be separated into in four cate gories Transfer data function allows procedure data to be transferred to the output device View data function allows the information recorded for a selected proced...

Page 126: ...ata acquisition menu and select an off line data acquisition function as follows Press the Mode key to receive the following screen display Figure 8 7 Off line data acquisition menu Press the Select k...

Page 127: ...ws the operator to determine which procedure information to send to the output device Device this selection will format the data according to the require ments of the connected output device The opera...

Page 128: ...Stop key returns the screen display to the data acquisition menu Select key toggles between the Procedure and the Device options Arrow keys used to select a procedure s or change settings of the Proce...

Page 129: ...tion will be displayed Figure 8 10 Example of the Procedure Volumes screen display Working with the Set Time function The device has an internal clock responsible for recording the time and date This...

Page 130: ...the Set Time menu has been changed Working with the Clear Data function The Clear Data function is used to erase all data stored in the CS5 memory When it is selected from the off line data acquisiti...

Page 131: ...es for printers not accepting the TAB character suitable for printers with 40 or more characters per line PC9600 Transmission at 9600 bauds in a spreadsheet compatible format PC19200 Transmission at 1...

Page 132: ......

Page 133: ...SPECIFIC CLEANING PROCEDURES 9 3 Cleaning the optical lenses 9 3 Cleaning the centrifuge well 9 3 Cleaning the fluid detectors 9 3 Cleaning the blood pump 9 3 Cleaning after a spill 9 4 Washing the a...

Page 134: ...or details of a Preven tive Maintenance Plan PMP for the CS5 equipment Warning To eliminate the potential danger of electrical shock the CS5 device must be disconnected from any power supply prior to...

Page 135: ...operator should never use full strength bleach directly on the device a bleach water solution or some other disinfectant may be indicated The centrifuge base contains mechanical chuck clips which must...

Page 136: ...d waste bag according to the local established pol icies for biohazard waste Washing the air filter The CS5 rear panel is equipped with an air filter for cooling incoming air to the device The filter...

Page 137: ...onetics seeks to provide the customer with equipment and material which respects the highest established standards of quality in design and manufacturing If for any reason the merchandise must be retu...

Page 138: ...should be done according to the locally established guidelines pertaining to the disposal of biologically contaminated material Warning Haemonetics products must be properly cleaned and packed prior...

Page 139: ...E BLOOD RECOVERY A 2 DESCRIBING CELL SAVER 5 ERROR CODES A 7 PRESENTING THE CS5 COMPATIBLE PRINTER A 11 Non thermal printer overview A 11 Changing the paper roll during a printing procedure A 11 Ribbo...

Page 140: ...Instat Hemopad Super Stat HemoFoam Activates clotting sequence by acting as a contact agent May clot off system Avoid aspiration in area where product is being used Resumption is an option after copio...

Page 141: ...Solution Examples 3 NaCl 7 NaCl Dextrose solutions Causes red cell crenation Avoid aspiration in area where product is being used Resumption is an option after copious irrigation with 0 9 sodium chlo...

Page 142: ...al of the amniotic fluid and copious irrigation with 0 9 sodium chloride solution to an alternate suction source B Bone Chips Bone Grafting Materials May cause clogging of the system Flush suction lin...

Page 143: ...d benefits should be discussed between the surgeon and the medical director of the surgical ser vices program Malignancy A Primary at Operative Site Cell salvage is widely used in surgical excision of...

Page 144: ...ntibody Agglutination of red cells may occur at temperatures lower than 37 C Cold agglutinins are in plasma and will be washed off If cold agglutinins show sig nificant activity at room tem perature r...

Page 145: ...t blue line Remove tubing and inspect area around clamp BLUE clamp position error Occurs whenever the clamp should be open closed but is not detected as open closed 5 System error Pump driver error Pu...

Page 146: ...ean bowl optics sensor and disposable Optics algorithm error Software was unable to initialize the optics algorithm task properly 23 Air sensor error Air sensor error 24 Air detected early Check tubin...

Page 147: ...sensor reading Precisionsensor input test Restart machine If failure continues call Haemonetics hot line Analog to digital converter error 37 System error Air detector Air detector error 38 Waste bag...

Page 148: ...t locked 46 Sensor is not calibrated Reservoir level Level sensor calibration error Level sensor calibration is out of the oper ating range 47 Sensor is not calibrated Waste bag weigher Waste bag weig...

Page 149: ...ew Figure A 1 Printer open with ribbon removed Changing the paper roll during a printing procedure To change the paper during a printing procedure the operator should Open the printer lid Remove the o...

Page 150: ...pen the printer lid Turn the wheel marked with an arrow until only the unused section of the ribbon is exposed To install a new ribbon Figure A 2 Removal of the ribbon by pressing on the PUSH EJECT te...

Page 151: ...y Emissions test Compliance Electromagnetic environment guidance RF emissions CSIPR 11 Group 1 The CS5 system uses RF energy only for its in ternal functions Therefore its RF emissions are very low an...

Page 152: ...de Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions volt age variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT...

Page 153: ...h frequency rangeb Interference may occur in the vi cinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not...

Page 154: ...ximum 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 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17...

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