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P/N 53063-30, Manual revision: B

xii

Table of Contents

. . . . . . . . . . . . . . . . . . . . . . 2-14

Harness tubing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  2-14
Receptacles and collection containers . . . . . . . . . . . . . . . . . . . . .  2-15
Centrifuge bowl . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  2-16
Describing the operation of the bowl . . . . . . . . . . . . . . . . . . . . . .  2-17

Chapter Three

Ensuring Safe Operation and Patient Care

. . . . . . . . . . . . . . . . . . . . . 3-2

Correctly storing and handling disposable material  . . . . . . . . . . . .  3-2
Avoiding electrical shock hazards . . . . . . . . . . . . . . . . . . . . . . . . .  3-2
Working with rotating machinery. . . . . . . . . . . . . . . . . . . . . . . . . .  3-3
Power outlet connection  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  3-3
Warning about communicable diseases . . . . . . . . . . . . . . . . . . . . .  3-3

. . . . . . . . . 3-4

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

Reinfusing blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  3-7
Replacing depleted clotting factors  . . . . . . . . . . . . . . . . . . . . . . . .  3-7
Contraindications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  3-7

. . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8

Cell Saving. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Sequestering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8

Chapter Four

Preparing for a Cell Saver 5+ Procedure

. . . . . . . . . . . . . . . . . . . . 4-2

Содержание Cell Saver 5+

Страница 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...

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Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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Haemonetics Cell Saver 5+, Руководство по эксплуатации

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