Service Manual
376 Pages
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SECTION 1: INTRODUCTION This service manual is intended for the person who will be servicing the COBE Spectra™ Apheresis System. It is extremely important that the service technician thoroughly read and understand the contents of this manual before attempting to repair or maintain the machine. Refer to the COBE Spectra™ Apheresis System Operator’s Manual for information on installation and operation of the Spectra system.
System Description The Spectra Apheresis System is intended to separate and collect blood components from both donors and patients. From donors, blood components are collected for transfusion to patients. For patients undergoing a therapeutic procedure, blood components are either depleted (e.g., platelet depletion) or exchanged (e.g., therapeutic plasma exchange). Currently, Spectra performs the following procedures: platelet collections and depletions, white blood cell removals, therapeutic plasma exchanges, and red blood cell exchanges. The Spectra system consists of disposables (preconnected channel and blood tubing) and a machine (apheresis system). The system components include the following: •
The Spectra Apheresis System – is an automated blood cell separator that provides the functions necessary to control and monitor the extracorporeal circuit during apheresis procedures.
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The Spectra Blood Tubing Set – consists of a channel that spins in the centrifuge to separate blood components and blood tubing that routes blood and replacement fluids through the system.
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The Spectra Apheresis System uses a continuous-flow centrifugal method (except in single needle) to separate whole blood into its major components: erythrocytes (red cells), leukocytes (white cells), platelets, and plasma. Whole blood is drawn from a donor or patient, anticoagulated, pumped into the centrifuge, and separated into components. The component removed is collected and the other components are returned to the donor/patient. For therapeutic plasma exchange procedures, replacement fluid is combined with the returned components.
The apheresis system is capable of operating under manual or automatic control. Under manual control, all flow rates and speeds (including anticoagulant and centrifuge) are adjustable. Under automatic control, operations are controlled by machine software calculations (algorithms) based on donor/patient data entered at the beginning of the procedure. This data – height, weight, and sex – is used to calculate the total blood volume (TBV) of the individual. Once Spectra accumulates this data, it can set pump flow rates and centrifuge speed to optimize blood separation by automatically controlling the RBC/plasma interface. The actual separation of blood components is effected inside the channel portion of the disposable blood tubing set. Another major feature of the Spectra is its ability to predict the platelet yield at the end of the procedure. The collect concentration monitor (CCM), an optical sensor used to count platelets, keeps the operator updated with current yield information. This allows the operator to make changes during the procedure, if necessary, to obtain the desired results.
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Spectra is also capable of performing a single needle procedure if it has been enabled and the operator has purchased a single needle flow controller. A unique aspect of the single needle software is the ability to convert from dual needle to single needle during the run.
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Disposable Blood Tubing Sets The Spectra blood tubing set is composed of the separation channel and the blood tubing that are preconnected for easy installation. Each blood tubing set separates whole blood into its major components. However, each blood tubing set has a different purpose for separation – three sets (configured as in Figure 1-1) are for collections and depletions; one set (configured as in Figure 1-2) is for therapeutic plasma exchanges and one set is for RBC exchange. The five sets are described as follows: 1. Extended Life Platelet Set, Catalog Number 777003-000 (ELP™ Set) – is a functionally closed set used either to collect donor platelets for storage up to 5 days or for therapeutic platelet depletions. This set consists of a dual stage platelet channel and extended life platelet blood tubing. •
Dual Stage Platelet Channel – collects platelets with low cross-cellular contamination. This is done in two stages: first, separate platelets from red and white cells; second, concentrate platelets by reducing plasma volume.
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Extended Life Platelet Tubing – collects platelets for extended storage through a functionally closed circuit consisting of tubing, access needle, platelet collect bag, plasma collect bag, and filters (sterile barriers used on incoming fluid lines).
2. White Blood Cell Set, Catalog Number 777006-000 (WBC Set) – is used to remove selected populations of white cells from individuals. This set consists of a single stage WBC channel and WBC blood tubing. •
Single Stage WBC Channel – separates white cell populations from red cells, platelets, and plasma.
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WBC Tubing – transports blood to remove white cells.
3. Therapeutic Plasma Exchange Set, Catalog Number 777005-000 (TPE Set) – is used to remove plasma from patients requiring therapeutic plasma exchange. This set consists of a single stage TPE channel and TPE blood tubing. •
Single Stage TPE Channel – separates plasma from the cellular components.
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TPE Tubing – transports blood for therapeutic plasma exchange procedures.
4. Red Blood Cell Exchange Set, Catalog Number 777007-000 – is used to remove RBC’s from patients requiring an RBC exchange. This set consists of a single stage RBCX channel and an RBC tubing set. •
Single Stage RBCX Channel – separates RBC’s from other cellular components.
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RBCX Tubing – transports blood for red blood cell exchange procedures.
5. Single Needle Extended Life Platelet Set, Catalog Number 777003-100 – is used to collect 5-day platelets the same as the ELP set, but also has a single needle expansion bag on the return side of the needle site so that a single needle procedure may be performed. 6. Single Needle Set, Catalog Number 777000-100 – consists of a single needle expansion bag with connecting tubing and a “Y” connector for the access and return lines. The single needle set is used to convert dual needle Therapeutic Plasma Exchange and Platelet sets to single needle operation. 7. Bone Marrow Processing Set, Catalog Number 777006-300 – is used to process and concentrate a container of harvested bone marrow (see Figure 1-5). This set is used in conjunction with a WBC set.
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Figure 1-1. Flow Diagram for Collection and Depletion Procedures
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Figure 1-2. Flow Diagram for Therapeutic Plasma Exchange (TPE)
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Figure 1-3. Flow Diagram for RBC Exchange (RBCX)
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Dual Stage Platelet Channel The dual stage platelet channel is used for platelet collections and depletions. Whole blood enters the first stage of the channel through the inlet tube. In the first stage, the red blood cells (RBC) and white blood cells (WBC) are separated from the platelet-rich plasma. The red cells and white cells exit the channel through the RBC tube (connected upstream to the control tube). Platelet-rich plasma flows over the dam into the second stage. The platelets are concentrated in the plasma by increased centrifugal force in the second stage and exit through the collect tube. The remaining plasma flows around the channel to the plasma tube where the larger volume exits. A small volume of plasma and red cells flows to the control tube to provide the interface control mechanism. The control is maintained by the balance of the pressure drops between the RBC and control tubes in conjunction with the density and viscosity of packed red cells and plasma.
Figure 1-4. Dual Stage Platelet Channel 1. Inlet Tube (Red) – where whole blood enters the channel. 2. First Stage – red cells and white cells are separated from platelet-rich plasma in this area of the channel between the control chamber (3) and the second stage (6). 3. Control Chamber – maintains the interface between the first and second stages. 4. Dam – separation point between the first (2) and second (6) stages. 5. Two Exit Tubes – are joined into one tube near the centrifuge collar: a. Red blood cell tube – with the larger diameter – where red cells and white cells exit the channel.
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b.
Control tube – with the smaller diameter – controls the position of the interface.
6. Second Stage – increased centrifugal forces in this area of the channel cause platelets to separate from plasma. 7. Platelet Collection Chamber – where platelets are concentrated before exiting the channel. 8. Collect Tube – where platelet concentrate exits the channel. 9. Plasma Tube – where plasma exits the channel.
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Bone Marrow Processing Set The Bone Marrow Processing Set (BMP set) is used in conjunction with the WBC set to remove selected populations (mononuclear cells) of white blood cells from harvested bone marrow product. The set consists of two bags from which to draw and return the bone marrow during each processing cycle. There is an access and return line on the set to attach to the access and return line of the WBC set.
PROCESSING BAG 1
PROCESSING BAG 2
ACCESSORY CONNECTOR
200 MICRON FILTER
RETURN LINE
ACCESS LINE
BONE MARROW BAG SPIKES
Figure 1-5. Bone Marrow Processing Set (used in conjunction with the WBC set)
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Single Stage WBC Channel The single stage WBC channel is used for white blood cell (WBC) removals. Whole blood enters the inlet chamber through the inlet tube. As it flows through the channel, it is separated into three layers: the red cells are on the outside, the buffy coat containing the selected white cells is in the center, and the plateletrich plasma is on the inside. The red cell/plasma interface is held in a constant position by the balance of the pressure drops in conjunction with the density and viscosity of the red cells and plasma flowing through the RBC and control tubes. The white cells are drawn from the channel through the WBC collect tube while the plasma and platelets exit through the plasma tube.
Figure 1-6. Single Stage WBC Channel
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1. Inlet Tube (Red) – where whole blood enters the inlet chamber (2). 2. Inlet Chamber – where whole blood enters the channel (3). 3. Channel – where centrifugal force and specific gravity cause whole blood to separate into selected components. 4. Collection Chamber – contains the exit tubes (5, 6, 7, and 8). 5. WBC Collect Tube – where white cells exit the channel. 6. RBC Tube – with the larger diameter – where red cells exit the channel. 7. Control Tube – with the smaller diameter – maintains the interface in the channel. The RBC and control tubes are joined into one tube near the centrifuge collar. 8. Plasma Tube – where plasma and platelets exit the channel.
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Single Stage TPE Channel The single stage TPE and RBCX channels are identical. The only difference in the tubing sets is that plasma and RBC exit tubes are reversed at the four-lumen manifold on an RBCX tubing set. The single stage TPE channel is used for therapeutic plasma exchange procedures. Whole blood enters the inlet chamber through the inlet tube. As it flows through the channel, all the cellular components settle to the outside with the plasma to the inside. Most of the plasma is withdrawn through the plasma out tube, and all the cellular components exit through the RBC return tube. The red cell/plasma interface is maintained in this channel by separating slightly more plasma from the cellular components than is withdrawn through the plasma out tube. The extra plasma then holds the red cell interface out at the RBC return port.
Figure 1-7. Single Stage TPE Channel
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1. Inlet Tube (Red) – where whole blood enters the inlet chamber (2). 2. Inlet Chamber – where whole blood enters the channel (3). 3. Channel – where centrifugal force and specific gravity cause plasma to separate from whole blood. 4. Collection Chamber – contains the exit tubes (5 and 6). 5. Plasma Out Tube – where plasma exits the channel. 6. RBC Return Tube – where cellular components (red cells, white cells, and platelets) exit the channel.
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Single Stage RBCX Channel The single stage TPE and RBCX channels are identical. The only difference in the tubing sets is that plasma and RBC exit tubes are reversed at the four-lumen manifold on an RBCX tubing set. The single stage TPE channel is used for therapeutic red blood cell exchange procedures. Whole blood enters the inlet chamber through the inlet tube. As it flows through the channel, all the cellular components settle to the outside with the plasma to the inside. The red blood cells are withdrawn through the red blood cell out tube, and the plasma exits through the plasma return tube. The red cell/plasma interface is maintained in this channel by separating slightly more plasma from the cellular components than is withdrawn through the plasma return tube. The extra plasma then holds the red cell interface out at the red blood cell out port.
Figure 1-8. Single Stage RBCX Channel
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1. Inlet Tube (Red) – where whole blood enters the inlet chamber (2). 2. Inlet Chamber – where whole blood enters the channel (3). 3. Channel – where centrifugal force and specific gravity cause plasma to separate from whole blood. 4. Collection Chamber – contains the exit tubes (5 and 6). 5. Plasma Return Tube – where plasma exits the channel. 6. RBC Out Tube – where red blood cells exit the channel for the red blood cell waste bag.
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SECTION 2: FUNCTIONAL DESCRIPTION The COBE Spectra™ Apheresis System, shown in Figure 2-1, can be divided into four sections: control panel, front panel, centrifuge chamber, and electronics compartment. A swivel arm on top of the machine holds the control panel that includes the keyboard and display screen. Below the swivel arm is the sloping front panel containing the pumps, valves, and sensors used by the system. The front of the machine opens to provide access to the centrifuge chamber. The rear of the machine opens to provide access to the electronics compartment.
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CONTROL PANEL AC LEVEL DETECTOR RETURN PRESSURE SENSOR PLASMA/COLLECT VALVES
AC PUMP
PLASMA/RBC PUMP
INLET PUMP
COLLECT/REPLACE PUMP
ACCESS PRESSURE SENSOR
WASTE/DIVERT VALVE
CENTRIFUGE PRESSURE SENSOR
RBC VALVE
COLLECT CONCENTRATION MONITOR (CCM)
RETURN LINE VALVE INLET AIR DETECTOR
RETURN AIR DETECTOR
CENTRIFUGE CHAMBER
Figure 2-1. COBE Spectra Apheresis System
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Control Panel Following is a description of the major components of the control panel: the LEDs, the keyboard, and the display.
Figure 2-2. Control Panel
LEDs Status Lights (Located Directly Above MUTE Key): •
SAFE LED – is a steady green LED that lights to indicate no alarm or warning conditions are present and all alarms are enabled (all safety systems are activated).
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WARNING LED – is a yellow LED that flashes to indicate warning conditions. It is a steady light if the warning condition is temporarily overridden or the machine is not in Run mode (some alarms are disabled in the Prime and Rinseback modes).
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ALARM LED – is a red LED that flashes to indicate alarm conditions. It is a steady light if the alarm condition is temporarily overridden.
ACCESS PRESSURE Bar Graph – is a LED bar graph that displays access pressure. There are 18 bars, at 25 mmHg per bar, ranging from 25 mmHg (at the top) to –400 mmHg. The first yellow bar corresponds to the warning limit (–200 mmHg). MANUAL LED – is a red LED located directly above the MANUAL key. It lights when the machine is performing a procedure in “Manual” overriding the automatic flow rates. MENU LED – a green LED located over the MENU ON/OFF key. It lights when the menu system is being used. PAUSE LED – is a green LED located over the PAUSE/CONTINUE key. It lights to indicate that the machine is in a Pause condition (the pumps are stopped). A flashing LED indicates that the pumps can be restarted by pressing the PAUSE/CONTINUE key. A steady LED indicates that an alarm condition must be removed before the pumps can be restarted.
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ENTER LED – is a green LED located over the ENTER/YES key. It flashes when the operator is expected to enter a number, answer a YES/NO question, or make a menu selection (when the ENTER key is a valid choice).
Keyboard The keys can be grouped into three major functional areas. The numeric keypad is located in the upper right-hand corner. The display keys are the 12 that surround the display screen (6 keys above and 6 keys below). The miscellaneous keys are located on the bottom row and left-hand side. Table 2-1. Three Categories of Keys Numeric Keypad Digit Keys (0 through 9) UP Arrow (increase) DOWN Arrow (decrease) Decimal Point CLEAR/NO ENTER/YES
Display Keys
Miscellaneous Keys
AC FLOW INLET FLOW PLASMA FLOW COLLECT/REPLACE FLOW INLET:AC RATIO SPIN RPM AC VOLUME INLET VOLUME PLASMA VOLUME COLLECT/REPLACEVOLUME TIME MIN TARGET VALUES
MUTE UNLOCK COVER STOP SPIN MANUAL VALVE CHANGE MODE MENU ON/OFF PAUSE/CONTINUE
When a key is depressed, a short beep will sound on the keyboard buzzer to tell the operator that it has been accepted. If the key is invalid in that situation, the message “xxxx key is invalid” will be shown on the display and a longer beep will be heard from the alarm buzzer. The message display is only shown for one second. This type of message will be shown if the key selected has no meaning, i.e., selecting a number when none is required. If the key selected has meaning but only in a certain sequence, the display message will say, “xxxx key; use xxxx first”. This means another key must be selected before the first key can be used. Keypad – The keypad is used to enter numeric data, make menu selections using numbers, answer YES/ NO questions, or move the strobe. Number Entry – If the machine requires numeric information, the ENTER LED will flash and the number on the display that needs to be changed will be surrounded by braces, i.e., {50} or, if no number has previously been entered, {0}. The operator can also change numeric information by using the UP and DOWN arrow keys. If these keys are pressed and released quickly, the display numbers will change only a small amount. If the keys are pressed and held down, the change will be larger. Some values that are changed (i.e., pump flow rates) will take immediate effect. Other changes (i.e., patient data or configurations) will only effect changes during certain machine situations. All numeric entries have upper and lower limits. If the upper or lower limit is violated using the UP/DOWN arrows, a triple beep will sound immediately. If the limits are violated using the digit keys, the triple beep will not sound until the ENTER/ YES key has been pressed.
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CLEAR/NO Key – This key has several functions: •
When entering numbers, this key restores the display to the previous values and prompts the operator to make another selection. When pressed during an UP/DOWN arrow number entry, the CLEAR/NO key cancels the entry.
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When making a menu selection, the CLEAR/NO key allows the operator to move backward through the menu and/or patient data screens.
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The CLEAR/NO key answers YES/NO questions as NO.
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If messages are stacked, like multiple alarms, pressing the CLEAR/NO key will reveal the additional messages one at a time and in order of priority. (For more details, see” Warning and Operator Attention Alarms” in Section 6–troubleshooting.)
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Pressing CLEAR/NO will also override yellow alarms (typically, for 60 seconds, 20 minutes, or indefinitely).
ENTER/YES Key – This key also has several functions: •
When making a specific menu selection, the ENTER LED will flash, prompting the operator to make the selection and press the ENTER/YES key.
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The ENTER/YES key answers YES/NO questions as YES.
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When making a menu selection, the ENTER/YES key allows the operator to move forward through the menu screens.
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The ENTER/YES key is used when entering numeric information.
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The ENTER/YES key can be used to restore the original message for an overridden alarm.
Decimal Point Key – This key has two functions: •
This key is used when entering decimal numbers (i.e., 8.5).
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This key is also used to enter the service menus. The service screens can be accessed by pressing the MENU ON/OFF key, the Decimal Point key, and the number of the service menu. To prevent the service menus from being entered by mistake, the service technician must first activate dip switch 1 (SW1-1) on the Master MPU CCA. The service menus can also be entered from the configuration menus by pressing the Decimal Point key. Another service operation, called Super Manual, can be entered by pressing the CHANGE MODE key and the Decimal Point key. (For more details, see Service Menu Screens in Section 5 – Service Menus.)
UP/DOWN Arrow Keys – These keys have two functions: •
To make number entries (as has been previously described).
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The UP/DOWN Arrow keys are also used to move the strobe flash location with respect to the separation channel. This enables the operator to view any part of the 360° circumference of the channel. Pressing the UP Arrow key causes the channel to appear to move to the right, while pressing the DOWN Arrow key makes it appear to move to the left. Each single press of a key moves the strobe image 1°. Pressing and holding an Arrow key allows the image to move 60o per second.
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