The contents of this manual are the property of the Haemonetics Corporation.
Any information or descriptions contained in this manual may not be
reproduced and released to any of the general public, or used in conjunction
with any professional instruction without written consent of Haemonetics
Corporation, USA.
Use of any portion(s) of this document to copy, translate, disassemble or
decompile, or create or attempt to create by reverse engineering (or otherwise)
the source code from the object code of Haemonetics products is expressly
prohibited.
DisclaimerThis manual is intended as a guide to provide the user with necessary
instructions on the proper use and maintenance of certain Haemonetics
Corporation products. This manual should be used in conjunction with
instruction and training supplied by qualified Haemonetics personnel.
Any failure to follow the instructions as described could result in impaired
product function, injury to the user or others, or void applicable product
warranties. Haemonetics accepts no responsibility for liability resulting from
improper use or maintenance of its products.
Utilization of Haemonetics products may require the user to handle and
dispose of blood-contaminated material. Users must fully understand and
implement all regulations governing the safe handling of blood products and
waste, including the policies and procedures of their facility.
Handling and use of any blood products collected or stored using Haemonetics
equipment are subject to the decisions of the attending physician or other
qualified medical personnel. Haemonetics makes no warranty with respect to
such blood products.
Patient diagnosis is the sole responsibility of the attending physician or other
qualified medical personnel.
The screenshots appearing in this manual are provided for illustrative purposes
only and may differ from the actual software screens. All organization, donor/
patient, and user names in this manual are fictitious. Any similarity to the name
of an organization or person is unintentional.
P/N SM-CS5-01-EN, Manual revision: ABHaemonetics® Cell Saver® 5/5+ Service Manual
3
Document
Updates
Trademarks and
Patents
The document is furnished for information use only, is subject to change
without notice and should not be construed as a commitment by Haemonetics
Corporation. Haemonetics Corporation assumes no responsibility or liability for
any errors or inaccuracies that may appear in the informational content
contained in this material. For the purpose of clarity, Haemonetics Corporation
considers only the most recent version of this document to be valid.
Haemonetics®, THE Blood Management Company®, and Cell Saver® are
trademarks or registered trademarks of the Haemonetics Corporation in the
United States and/or other countries.
Other product names in this document may be trademarks of their respective
proprietors and are used for identification purposes only.
Reader comments
Any comments or suggestions regarding this publication are welcomed and
should be forwarded to the attention of:
Haemonetics® Cell Saver® 5/5+ Service ManualP/N SM-CS5-01-EN, Manual revision: AB
14Introduction
Overview
What is the
purpose of this
manual?
This service manual provides detailed information for the installation and
maintenance of the Haemonetics® Cell Saver® 5 Autologous Blood Recovery
System.
The manual includes the following:
Detailed descriptions of the device and all components
How to troubleshoot and repair any difficulties
How to properly maintain the device
Use this manual in conjunction with training supplied by qualified Haemonetics
personnel.
This manual covers device list numbers
02005-110
02005-110-EP
02005-110-EPJ
02005-220-E
02005-220-EP
P/N SM-CS5-01-EN, Manual revision: ABHaemonetics® Cell Saver® 5/5+ Service Manual
Introduction15
Symbols
Symbols found
in this
document
Symbols found
on the device
The terms Note, Caution, and Warning are used in this manual, with the
following symbols, to emphasize certain details for the operator:
Note: Provides useful information regarding a procedure or operating
technique when using Haemonetics material.
Caution: Advises the operator against initiating an action or creating a situation which could result in damage to equipment, or impair the quality of the
blood products; personal injury is unlikely.
Warning: Advises the operator against initiating an action or creating a
situation which could result in serious personal injury to the donor, the
operator, or the blood product recipient.
The following symbols may be found on the device or device packaging:
Attention
Consult accompanying documents.
Type CF
Type CF applied part provides a particular degree of protection
against electric shock; particularly regarding allowable-leak-
age current and reliability-of-the-protective-earth connection.
Electrical and electronic equipment waste (applies to EU
only)
Dispose of the device using a separate collection method (according to EU and local regulation for waste electrical and
electronic equipment).
IPX1
Haemonetics® Cell Saver® 5/5+ Service ManualP/N SM-CS5-01-EN, Manual revision: AB
Protection against ingress vertically dripping water
Indicates that the enclosure of the device is designed to be
drip-proof, providing a higher-than-ordinary protection level
from drips, leaks, and spills.
Manufacturer
Alternating Current
16Introduction
Fuse
Equipotentiality
Identifies the terminals, which, when connected together,
brings various parts of a system to the same potential.
Authorized representative in the European Community
Rx only (applies to USA only)
Federal (USA) law restricts the sale of the device to be included by or on the order of a physician, only.
Serial number
Catalog number
0123
ETL
Laser radiation
Shock hazard
CE Mark
General symbol for recovery/recyclable
To indicate that a material is part of a recovery/recycling process.
Note: Applicable only to those products or materials for which,
at the end of life, there is a well-defined collection route and re-
P/N SM-CS5-01-EN, Manual revision: ABHaemonetics® Cell Saver® 5/5+ Service Manual
Introduction17
cycling process, and which does not significantly impair the effectiveness of other recycling schemes.
250 mmHg
Maximum vacuum
Pollution control mark
Pollution control mark for products containing any of the six referenced substances (Lead, Mercury, Cadmium, and so on) according to new Chinese regulations.
Storage conditions, humidity level
Storage conditions, temperature level
Storage conditions, keep dry
Fragile, handle with care
This end up
Read the instruction manual
Haemonetics® Cell Saver® 5/5+ Service ManualP/N SM-CS5-01-EN, Manual revision: AB
18Introduction
System overview
All Haemonetics Cell Saver® Autologous Blood Recovery Systems process
whole blood salvaged from the surgical field so that it may be reinfused to the
patient. Inside a spinning processing chamber (bowl) red blood cells (RBCs)
are separated from other blood components, such as platelets and plasma,
and from debris suctioned from the surgical site. The separated RBC are then
washed with saline solution. The washed, packed RBC may then be reinfused
to the patient. The Cell Saver 5/5+ can also collect platelet rich plasma (PRP)
before surgery.
The Cell Saver 5/5+ represents the fifth generation of Cell Saver 5/5+
Autologous Blood Collection Systems from Haemonetics. The CS5/CS5+
provides the highest level of automation available in a blood salvage system.
The design goal of the CS5/CS5+ was to produce a system that would rapidly
process a large volume of salvaged blood while keeping operation simple.
Great attention was given to keeping the control panel simple while providing
the operator with constant feedback on the operation of the device.
The control-panel displays only the keys that are available to the operator.
Manual operation keys are not visible in the automatic mode.
The tubing harness uses a manifold, so that the disposable setup is faster and
easier, while the possibility of improperly installing the tubing into the valves is
eliminated. The processing chamber, a Latham bowl, is held in place with a
mechanical chuck, making installation faster and easier. The top portion of the
bowl is visible, so that the operator can monitor blood separation.
The Cell Saver 5/5+ system consists of two parts: a device and a single-use
disposable set.
P/N SM-CS5-01-EN, Manual revision: ABHaemonetics® Cell Saver® 5/5+ Service Manual
Introduction19
The major device components are identified in Figure 1.
Reservoir holder
with level sensor
Pigtails for saline,
anticoagulant and
Control panel
Fluid deck (with
valves, air detectors,
and pump)
reinfusion bags
Centrifuge
(with bowl optics
and fluid sensors)
Cover lock
Effluent-line sensor
Waste-bag
weigher hooks
Figure 1, Haemonetics® Cell Saver® 5+ Autologous Blood Recovery System
The centrifuge holds the disposable bowl in place and spins it at high
speed. Inside the bowl, red blood cells (RBCs) are separated from other
blood components, debris, and saline.
Bowl optics monitor the spinning bowl to determine the appropriate
moment to initiate certain actions such as cell washing.
Valves control the fluid pathway of the disposable tubing set.
A pump moves fluids through the tubing set. Salvaged whole blood is
brought from the reservoir into the bowl for processing. Saline wash
solution is brought from the saline bags on the IV pole to the bowl to wash
RBCs. The final product, washed packed RBCs, is pumped to a reinfusion
bag.
Haemonetics® Cell Saver® 5/5+ Service ManualP/N SM-CS5-01-EN, Manual revision: AB
20Introduction
An effluent linesensor monitors the line from the bowl to the waste bag
to ensure that a minimum of RBC are lost and that the Wash mode is
complete.
A waste bag weigher alerts the operator when the waste bag is full.
Figure 2 identifies major disposable set components:
HAEMONETICS
IOOO
9OO
8OO
7OO
6OO
5OO
4OO
Reinfusion bag
3OO
Saline (yellow) line
2OO
IOO
MILLILITERS
(APPROXIMATE)
DO NOT USE WITH PRESSURE CUFF
To reservoir
To saline bags
Reinfusion (blue) line
Reservoir (red) line
Centrifuge bowl
Tubing manifold
10
9
8
7
6
5
4
3
2
1
Waste bag
Figure 2, Cell Saver 5/5+ disposable set
The bowl is the main disposable component. Inside the spinning bowl,
RBCs are separated from other blood components and from debris that
may have been collected along with the whole blood. The 70 ml bowl is
the blow-molded-bowl design (not shown).
A tubing manifold is installed into a keyed slot on the CS5/CS5+ deck.
The keyed slot ensures that the tubing lines are installed in the
appropriate valves. There are three lines and three corresponding valves.
(The red line leads to the reservoir, the yellow line leads to the saline
bags, and the blue line leads to the reinfusion bag.)
A waste bag holds the supernatant and waste fluids, which flow out of the
spinning bowl as the red blood cells (RBCs) are washed.
A reservoir (not shown) stores whole blood and saline, which are
collected from the surgical field. The reservoir has a gross filter, which
removes large debris. The red line of the CS5/CS5+ disposable set
attaches to the reservoir.
Two saline bags (not shown) are connected to the bag spikes on the
yellow saline line.
A reinfusion bag is connected to the blue reinfusion line. After they are
processed, washed red blood cells suspended in saline are sent to this
bag.
P/N SM-CS5-01-EN, Manual revision: ABHaemonetics® Cell Saver® 5/5+ Service Manual
Introduction21
Additional support
Many factors affect the performance of blood processing instruments, including
the functional integrity of the device, the consistency of the disposable set, and
the quality of blood salvaged.
This manual attempts to anticipate any service needs of the Cell Saver 5/5+. If
this manual does not answer your questions, call the Haemonetics Customer
Care Center at (800) 537-2802. For locations outside the U.S., contact the
Haemonetics local office.
See “Haemonetics Worldwide” on page 3 for a list of local offices.
Haemonetics® Cell Saver® 5/5+ Service ManualP/N SM-CS5-01-EN, Manual revision: AB
P/N SM-CS5-01-EN, Manual revision: ABHaemonetics® Cell Saver® 5/5+ Service Manual
Principles of operation25
Introduction
CS5/CS5+ devices manufactured after approximately October 2000 no longer
utilize the backplane PCB (P/N 36728-00) with the personality PCB (P/N
37253-00). These PCBs are combined in the new backplane PCB (P/N 49488-
00). The CS5/CS5+Service Manual chapters (Chapter 2, "Principles of
operation", Chapter 5, "Troubleshooting"; and Chapter 6, "Disassembly")
assume this newer configuration of the backplane PCB (P/N 49488-00). For
guidance on operation, troubleshooting, or disassembly of the older versions
of PCBs, refer to prior revisions of the CS5 Service Manual or contact the
Haemonetics Customer Care Center.
Haemonetics® Cell Saver® 5/5+ Service ManualP/N SM-CS5-01-EN, Manual revision: AB
26Principles of operation
Safety card
Safety featuresThe following safety features are designed into the Cell Saver® 5:
Electrical safety
IEC 601-1:1988 medical equipment requirements for safety
EN 601-1-2:1993 EMC compliance
Logic supply over/under voltage
Overspeed limit for centrifuge
Mechanical safety
Centrifuge/pump construction
Interlocks
Cabinet design
Protection from over/under pressure
Pump agreement (direction/speed) with device state
Function and
safety structure
Motor driver-fault detection
Continual checking of CPU status and motor/valve feedback in order
to confirm device state
The safety card addresses all aspects of pump agreement with device state
and several aspects of electrical and mechanical safety.
The following is an outline of the function and safety structure employed by the
CS5/CS5+:
A single microprocessor (μP) has control tasks for the function of the
system.
The safety system consists of an independent, hardware safety board —
CS5/CS5+ safety card.
The μP performs a self-test during T1-test (RAM, ROM, registers and
safety I/O) to verify its functionality.
The safety system is tested by the μP, before every procedure, to see
whether it can fulfill its tasks in the correct manner.
The μP and safety card read the same input signals.
The μP sends test codes to the safety card; if any disagreement occurs,
the safety card sends an error message to the μP.
Both the μP and the safety card are able to stop the function of the system
by independent shutdown paths (de-energizing motor and valves) and
initiate acoustical alarms (unsafe equipment state).
When the μP T1 and safety card tests are completed the CS5/CS5+ is
considered a one-channel system (single fault analysis).
P/N SM-CS5-01-EN, Manual revision: ABHaemonetics® Cell Saver® 5/5+ Service Manual
Principles of operation27
Sensor
T
Theory of
operation
The safety card is a system that accepts direct CPU information as to the
device state; it independently verifies this state via a pump encoder and valve
feedback; it tests all appropriate sensor-safety limits, as defined for this state;
and if a fault condition is detected, it removes power from both pumps and
valves. Further, whenever a fault condition exists, an audible alarm is sounded
and information, as to its cause, is latched and made available to the CPU for
diagnostic purposes.
For a better understanding of how the safety card is integrated and used within
the CS5/CS5+, refer to the block diagram in Figure 3.
First, note that the upper relay, known as the safety or K1, controls the power
applied to both the valves and pumps. This relay will be opened whenever a
critical fault condition is indicated by the CPU or safety card.
The output contact of K1 is sensed and the on/off status is readable by the
CPU. At power-up and at the start of each procedure, this relay is tested by the
CPU.
The second relay is known as the pump or K2 relay and it controls the power
applied to the pumps. The safety card has exclusive control over it. The status
of this relay is also sensed and made available to both the CPU and the safety
card.
K1 and K2 will be opened whenever a safety fault is encountered by the safety
card.
est
Signals
Sensors
K2 is opened/closed for each safety card test executed at the beginning of a
procedure or when a standby (Manual/Stop) mode is required.
Fault
Summer
Drv
CPU
Relay Feedback
Drv
+28v
+
–
Safety/
Master Relay
K1
Valve
Power
Safety
+
–
Pump Relay
K2
Pump
Power
Isolated
Outputs
Card
Sensor
Relay Feedback
Figure 3, Safety card functional block diagram
Haemonetics® Cell Saver® 5/5+ Service ManualP/N SM-CS5-01-EN, Manual revision: AB
28Principles of operation
Safetycard
state codes/
interface
requirements
Input register
The sole input port, for the safety card, is an 8-bit register (supporting read
back), which accepts state/test codes from the CPU. These codes are used by
the safety card in order to verify the device state as indicated by independent
sensors.
Whenever a new, device state (determined by valve and pump operation) is
called for, a code, representing this state, must be issued by the CPU.
This code is written to the safety card before the actual change of device state
is executed. This allows the safety card to distinguish between a normal state
advance and a state fault condition.
Data format
The 8-bit data information is partitioned into two fields. The first field consists
of 5 bits (D0 through D4) and is dedicated to command/state information. (Each
code possesses a minimum Hamming Distance of two.) The second field,
formed by the remaining bits (D5 through D7), is used to provide test signals.
A description of each field is given in Table 1.
Note: In order for the safety card to recognize the correct pump activity when
transitioning from one state to another, it will be necessary to transition through
the Pause or Standby state first (i.e., change code, because re-issued codes
are not recognized).
Table 1, Test code field
D7D6D5Test
identifier
000NulNo testing
010State testNormally during the test phase
100Beeper testTo avoid annoying beeps during
110Time base testIntended to be used to simulate a
Test description
generation of a state fault is
inhibited (replaced by a motormovement fault). This code is
used as an override to ensure
that a state fault can open the
pump relay.
test, the beeper is disabled. This
code allows a test beep and is
required in order to enter the
application phase.
safety card clock failure, it also
aids (reduces the time required)
to synchronize the watchdog
signal.
P/N SM-CS5-01-EN, Manual revision: ABHaemonetics® Cell Saver® 5/5+ Service Manual
Principles of operation29
Table 1, Test code field (Continued)
Safety
operational
sequence
D7D6D5Test
identifier
001Spare testReserved for interlock application
011Not used
111Not used
101Not used
111Not used
Test description
Input register guidelines
After a code is issued by the CPU, proper pump and valve commands should
be issued (executing the code action).
Refer to the flow chart in Figure 4 as an aid in understanding the system
interactions with the safety card.
Haemonetics® Cell Saver® 5/5+ Service ManualP/N SM-CS5-01-EN, Manual revision: AB
30Principles of operation
There are two basic phases of operation to consider for the safety card: the test
phase and application phase.
Test Phase
Application Phase
Power On Reset
Test Entry Code
Timing Verification
Relay Testing
Beeper Check
State Fault Test
Recovery Path
Application Entry Code
Watchdog, 5V Supply Pumps and
Clamps Continuously Monitored
Pause
Standby
Conc
Pump Relay
Deenergized
During Pause Interlocks May Be Tested.
**
Figure 4, Safety card test-flow diagram
**
Clear Test Checklist
*
Normal
Operation
Standby Code
Check Interlocks
*
Test Checklist
*
Sequence Tests
Allowed
WashFill
Return
“Load
*
Disposable”
Test phase
The sequence starting point is defined by entry into the test phase. This phase
is entered whenever the safety card receives a start code.
There are two ways that can happen:
At power-up, the start code is obtained by default via the bus reset signal.
During operation by direct CPU input of this code — used before initiating
a new procedure.
During this phase, the complete end-to-end testing of the safety card is
accomplished by the CPU outputting state codes and exercising sensor testlines, then verifying the pump relay response and the safety card’s output
register data.
The key differences in functionality between test and application phases are:
P/N SM-CS5-01-EN, Manual revision: ABHaemonetics® Cell Saver® 5/5+ Service Manual
Loading...
+ 294 hidden pages
You need points to download manuals.
1 point = 1 manual.
You can buy points or you can get point for every manual you upload.