OrthoPAT Operation Manual Rev B March 2004

Page 1

Working with

the Haemonetics® OrthoPAT®

Orthopedic Perioperative Autotransfusion System

Operation Manual

0123

HAEMONETICS®

Printed in France

Haemonetics Corporation

400 Wood Road

Braintree, MA 02184, USA

©2004, Haemonetics International. All rights reserved.

P/N 85252-30, Manual revision B

March 2004

Page 2

ii

Consumer information

Proprietary rights

The contents of this manual are property of

the Haemonetics Corporation. Haemonetics®, OrthoPAT® and Dynamic Disk™ are

registered trademarks 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.

Please direct any written inquiries to the

appropriate address.

International Headquarters

Haemonetics SA

Signy Centre, rue des Fléchères

P.O. Box 262

1274 Signy 2, Switzerland

Tel. [+41 22] 363 90 11

Fax [+41 22] 363 90 54

Corporate Headquarters

Haemonetics Corporation

400 Wood Road

Braintree, MA 02184, USA

Tel. [1-781] 848 7100

Fax [1-781] 848 5106

Legal disclaimer

This manual is intended for use as a guide,

uniquely for material as supplied by the

Haemonetics Corporation. It provides the

operator with necessary information to

safely carry out specific procedures and

satisfactorily maintain Haemonetics

produced equipment. The manual is to be

used in conjunction with instruction and

training as supplied by qualified Haemonetics personnel, or its authorized distributor.

P/N 85252-30, Manual revision B

OrthoPAT - Preface

Haemonetics 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 injury

to the operator and/or patient. When properly assembled, maintained and operated

properly, the OrthoPAT perioperative

autotransfusion system can safely and

adequately perform various cell salvaging

procedures.

Haemonetics accepts no responsibility for

problems resulting from failure to comply

with prescriptions as outlined by the

company.

Any modifications estimated as necessary

by the customer should be evaluated by a

Haemonetics clinical specialist.

Safe utilization of Haemonetics material

and equipment requires the operator to

correctly handle and dispose of bloodcontaminated material. The operator of any

Haemonetics equipment must understand

and implement the local policies and standard operating procedures concerning the

handling of blood-contaminated material,

as well as blood products.

It remains solely the responsibility of the

customer to fully assess and ensure the

safety of any products obtained from

Haemonetics prescribed procedures, prior to

further application or use. Haemonetics

declines any responsibility for choices made

by the consumer concerning the utilization

of these products and by-products.

USA Federal Law restricts this device to sale

by or on the order of a physician.

Page 3

OrthoPAT - Preface

iii

Symbols found in this document

Haemonetics worldwide

The terms Note, Caution and Warning are

used in this manual with the following

symbols to emphasize certain details for

the operator.

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

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 by-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 either the patient or the operator.

!

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.

Haemonetics GesmbH

Handelsges.m.b.H.

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P/N 85252-30, Manual revision B

Page 4

iv

Haemonetics France S.A.R.L.

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P/N 85252-30, Manual revision B

OrthoPAT - Preface

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 SA

Signy Centre, rue des Fléchères

P.O. Box 262

1274 Signy 2, Switzerland

Tel. [+41 22] 363 90 11

Fax [+41 22] 363 90 54

Page 6

vi

OrthoPAT - Table of contents

Section 4

System Operation

Mounting the system on an IV pole...................................4-2

Loading the disposable set ..............................................4-3

System initialization.......................................................4-6

Intraoperative operation mode .........................................4-7

Starting Intra-op RUN mode ........................................4-7

Intra-op volume accounting (EBL) ................................4-8

Intra-op processing cycle ............................................4-9

Transitions out of Intra-op RUN mode......................... 4-10

Postoperative operation mode ........................................ 4-11

Starting Post-op RUN mode ....................................... 4-11

Post-op volume accounting (EBL)............................... 4-12

Post-op processing cycle ........................................... 4-13

Transitions out of Post-op RUN mode.......................... 4-14

STANDBY mode ............................................................ 4-14

Transitions out of STANDBY mode............................... 4-14

Process function .......................................................... 4-15

Process Until Empty function ......................................... 4-15

Suction function .......................................................... 4-16

Alarm mute ................................................................. 4-16

Battery power operation................................................ 4-16

Removing the disposable set.......................................... 4-17

Estimated Blood Loss volume accounting sheet................. 4-18

In INTRA-OP mode ................................................... 4-18

In POST-OP mode ..................................................... 4-18

Section 5

Clinical Operation

Transition from INTRA-OP to POST-OP ................................5-2

Transfusing recovered RBCs..............................................5-2

Replacing RBC bags ........................................................5-3

Replacing the waste bag .................................................5-3

Replacing the saline bag .................................................5-4

Spare suction lines .........................................................5-4

Patients returning to surgery ...........................................5-4

Section 6

Troubleshooting

Introduction..................................................................6-2

Event notifications and error messages .........................6-2

Component failures ....................................................6-2

General operation ......................................................6-2

Disposable loading ................................................... 6-10

Intraoperative operation ........................................... 6-12

Postoperative operation............................................ 6-13

P/N 85252-30, Manual revision B

Page 7

OrthoPAT - Table of contents

vii

Battery power.......................................................... 6-14

Power interrupt recovery ............................................... 6-15

Opening cover after power interrupt ........................... 6-15

Capacity overflow......................................................... 6-15

Blood transfer after a blood spill .................................... 6-15

Postoperative blood transfer...................................... 6-16

Intraoperative blood transfer ..................................... 6-19

Replacing the spill collection bag............................... 6-22

Section 7

Facilities, Maintenance and Storage

Facilities ......................................................................7-2

Storage ........................................................................7-2

Quality assurance ...........................................................7-2

Operator care ................................................................7-2

Servicing ..................................................................7-2

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

Preventative maintenance ...........................................7-3

Cleaning the device after a blood spill...............................7-4

Cleaning the centrifuge ..............................................7-4

Cleaning the RBC detector...........................................7-5

Cleaning the optics window.........................................7-5

Customer Service............................................................7-5

Clinical training.........................................................7-5

Field service..............................................................7-5

Returned goods authorization system (RGA)...................7-5

Appendix A

System Specifications

Specifications................................................................A-2

Dimensions and weight ............................................. A-2

Power supply ........................................................... A-2

Other characteristics ................................................ A-2

Symbols found on the device ...........................................A-3

Symbols found on disposable packaging ............................A-3

Appendix B

The Dynamic Disk

Disk components........................................................... B-2

How the separation chamber works .................................. B-2

How the disk works ....................................................... B-3

P/N 85252-30, Manual revision B

Page 9

Section 1

Introduction

Background...................................................................1-2

System description .........................................................1-2

Principles of operation....................................................1-3

Benefits .......................................................................1-4

Patient benefits.........................................................1-4

Operator benefits .......................................................1-4

Cost effectiveness ......................................................1-4

P/N 85252-30, Manual revision B

Page 10

1-2

Background

Autotransfusion is a technique of salvaging

and reinfusing red blood cells (RBCs) from

blood shed by a patient due to surgery or

trauma. Reinfusing the salvaged RBCs

reduces the patient’s need for allogeneic

blood transfusion. The technique was first

developed for use in cardiovascular surgery

but is used increasingly in orthopedic

procedures as well.

Autotransfusion devices separate the intact

RBCs from the undesirable components in

the fluid portion of the shed blood and the

surgical irrigating solutions. The separated

RBCs are then available for reinfusion to

the patient. Autotransfusion devices use

either centrifugation or filtration to separate the RBCs.

Many autotransfusion devices salvage RBCs

from blood shed in the surgical field. Intraoperative autotransfusion has become standard medical practice in many

cardiovascular, trauma and transplant

procedures. During intraoperative autotransfusion, blood is suctioned from the

surgical site, anticoagulated and collected

into a reservoir. When there is a sufficient

quantity of shed blood in the reservoir, it is

processed through a separation chamber to

concentrate the RBCs and remove the

supernatant fluid. Some systems will then

further purify the RBCs by washing them

with saline.

Systems have also been developed to

salvage RBCs from blood shed from the

surgical wound site after surgery. In most

surgical procedures the surgeon places

wound drain tubing into the wound to allow

fluid to drain out of the body. Wound drains

are designed to prevent postoperative fluid

build-up which may delay healing, increase

P/N 85252-30, Manual revision B

OrthoPAT - Introduction

pain and increase the chance of infection.

Postoperative autotransfusion is the collection and reinfusion of the blood lost

through the wound drain. Most postoperative autotransfusion systems do not separate and wash the RBCs, but merely filter

the wound drainage to remove any large

blood clots.

The OrthoPAT perioperative autotransfusion

system represents a new approach to

autotransfusion. It is designed specifically

for use in orthopedic procedures of significant blood loss such as joint replacement

and spinal fusion. The same disposable set

is used intraoperatively and postoperatively

to provide perioperative autotransfusion,

salvaging RBCs whenever and wherever

blood is lost, both during and after surgery.

RBCs are separated from waste products by

centrifugation during both intraoperative

and postoperative processing. They are

then washed and reconcentrated for greater

purity.

The OrthoPAT system represents the first

comprehensive approach to orthopedic

autotransfusion.

System description

The OrthoPAT system is designed to provide

perioperative autotransfusion for patients

undergoing orthopedic surgery.

The system consists of single-patient use

disposable sets and an electromechanical

device which together collect and process

the RBCs lost during and after surgery.

The small and highly portable system

mounts onto an IV pole and is designed to

be used both in the operating room to

recycle blood lost during surgery, and in the

recovery room, to recycle blood lost after

surgery.

Page 11

OrthoPAT - Introduction

It can then be transported with the patient

to the floor to continue postoperative

salvage.

The disposable set is the only part of the

system that comes in contact with the

patient’s blood. It has a sterile fluid

pathway for use by a single patient both

during and after a single surgical procedure.

The heart of the system is a centrifuge disk

in which the red cells are separated from

supernatant and washed. The OrthoPAT disk

is distinctive in that it dynamically changes

size while it is spinning and provides a

consistent hematocrit product regardless of

the volume or hematocrit of blood

processed.

The disposable set also includes a reservoir

to hold the blood and fluid aspirated from

the surgical field or suctioned from the

wound drain prior to processing. It also

includes a bag for holding the processed

RBCs and a waste bag.

Tubing and valve systems interface with the

electromechanical device to control the

flow of fluid between the reservoir, disk and

bags.

The electromechanical device consists of a

centrifuge, pneumatic system, valve

controllers, sensors and computer which

control the processing and monitor the

operation of the system.

A display unit shows the operator the

volume of fluid that has been collected and

allows the operator to switch the system

between intraoperative and postoperative

operation. It also informs the operator

should an error occur during operation.

The system operates automatically with

little operator intervention beyond loading

the disposable set.

1-3

Principles of operation

Blood shed from either the surgical site or

the wound drain is suctioned into the reservoir of the system. The reservoir contains a

large mesh filter that retains any bone fragments, blood clots, or other large debris

that may be found in shed blood.

The shed blood and aspirated fluid are

stored in the reservoir until there is sufficient volume, after which the OrthoPAT

system initiates processing.

The OrthoPAT system continues automatically to process blood as long as there is

sufficient fluid in the reservoir. During

automatic processing, blood is pulled into

the disk in 100 ml batches.

The system can be manually overridden to

process less than 100 ml when necessary.

In the disk, centrifugal force is used to

separate intact red blood cells from the cell

fragments, irrigation fluid, plasma, and

other undesirable components that are

found in the fluid portion of the shed

blood.

The RBCs travel to the outside edge of the

spinning disk.

The disk is then compressed to push the

undesirable supernatant out and into the

waste bag.

After the waste supernatant has been

removed, the red blood cells are then

washed with saline to further purify the

RBCs and remove undesirable components.

The dynamic disk’s ability to obtain a very

high concentration of the RBCs prior to the

rinse step results in an extremely efficient

washout of undesirable components.

P/N 85252-30, Manual revision B

Page 12

1-4

OrthoPAT - Introduction

Benefits

Cost effectiveness

The OrthoPAT system offers benefits to the

patient, the operator and the medical institution.

A single disposable processing set for RBC

salvage used both during and after surgery

is less costly than using separate disposable processing sets for intraoperative and

postoperative salvage.

Patient benefits

By salvaging intact RBCs from perioperative

blood, the OrthoPAT system potentially

reduces the patient’s need for allogeneic

blood transfusion, thereby reducing the risk

of allogeneic transfusion reaction and

transmission of infectious disease.

The OrthoPAT system may potentially reduce

the number of predonated autologous units

required to completely support a patient’s

surgical need.

The OrthoPAT system provides a consistently high hematocrit RBC product. The

amount of excess fluid and contaminants

that the patient might receive from other

autotransfusion techniques is reduced.

Internal vacuum control and battery backup assure consistent, uninterrupted suction

on the wound drain site, even during

patient transport.

Operator benefits

The disposable set loads easily into the

OrthoPAT system.

The OrthoPAT system is fully automated and

requires little operator interaction with the

system beyond loading the disposable.

Continuous display of the volume of fluid

collected from either the surgical site or

the wound drain simplifies charting of the

patient’s fluid balance.

The small portable system is easy to transport, clean and store.

P/N 85252-30, Manual revision B

Salvaging RBCs whenever the blood is lost

makes autotransfusion cost effective for

patients for whom the volume of intraoperative or postoperative blood loss alone

could not justify the cost of autotransfusion.

Since the fully automated OrthoPAT system

does not require a dedicated operator to

monitor its operation, there is no additional labor cost for providing perioperative

autotransfusion to the patient.

Page 13

Section 2

Clinical Use

Indications for use .........................................................2-2

Contraindications ...........................................................2-2

Patient safety warnings...................................................2-3

Operator safety warnings.................................................2-3

Potential adverse effects .................................................2-3

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

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

P/N 85252-30, Manual revision B

Page 14

2-2

OrthoPAT - Clinical Use

The decision to use autotransfusion and

reinfuse salvaged RBCs is entirely within

the domain of the responsible medical

team. The following recommendations are

based upon generally accepted medical

practice regarding autotransfusion.

Contraindications

Autotransfusion is generally contraindicated in the following circumstances:

!

In the presence of systemic infection.

!

Blood salvaged from the surgical field

contaminated by bacteria from an active

infection at wound or drain site.

!

Malignant cells mixed with the blood

salvaged from the surgical field.

!

Salvaged red blood cells contain sickle

cell hemoglobin.

!

Prostatic fluid or amniotic fluid mixed

with the blood salvaged from the

surgical field.

!

The collected blood contains certain

topical hemostatic agents, anti-bacterial agents or wound irrigants not

intended for parenteral use, that may

damage RBCs or are inappropriate for

infusion.

!

During cement application: Methylmethacrylate or other cements may

cause hemolyses of RBCs.

Indications for use

The OrthoPAT orthopedic perioperative

autotransfusion system is indicated for use

to salvage RBCs from blood lost intraoperatively and postoperatively during surgical

procedures where the expected rate of

processing of salvaged blood and fluid aspirated from the surgical site is less than or

equal to 2 liters per hour. Autotransfusion

is indicated for patients who meet at least

one of the following criteria:

!

!

The patient is expected to lose sufficient

blood in the perioperative period so as

to require RBC transfusion, and

autotransfusion will likely reduce or

eliminate the need for allogeneic blood

transfusion.

Religious beliefs cause the patient to

refuse allogeneic transfusion, but accept

autologous transfusion.

!

Compatible allogeneic blood is not available.

!

The patient is unable to donate sufficient quantities of autologous blood

prior to surgery to adequately cover the

anticipated transfusion requirement.

!

The patient or physician prefers perioperative autotransfusion rather than

preoperative autologous donation or

transfusion of allogeneic blood.

P/N 85252-30, Manual revision B

The OrthoPAT system is designed for blood

loss rates commonly seen in elective orthopedic surgery. The OrthoPAT processes up to

2 liters of fluid per hour.

It is not appropriate for procedures

involving high, rapid blood loss such as

liver transplants or certain cardiovascular

procedures.

Some trauma procedures may also be

contraindicated, particularly where blood

loss is high and it is necessary to return

processed RBCs rapidly, or where there is a

possibility of contamination from an open

wound.

Page 15

OrthoPAT - Clinical Use

Patient safety warnings

2-3

Potential adverse effects

"

Do not suspend the OrthoPAT system

above the patient on an orthopedic cage

or bed-mounted IV pole. A falling instrument could cause serious injury.

Although autotransfusion is a well accepted

medical practice there are some potential

adverse effects associated with the procedure. These include:

"

Clearly label the RBC bag for AUTOLOGOUS USE ONLY and with the patient

name, ID and collection start time.

Match the patient name and ID to the

label on the unit prior to reinfusing.

!

Pressurized reinfusion of salvaged RBCs

may cause air embolism by forcing any

air in the RBC bag into the patient's

circulation.

!

Infusion of the RBCs without a filter

could introduce micro-emboli into the

patient’s circulation.

!

The materials in the disposable set or

the anticoagulants or rinse solutions

used in autotransfusion may, in rare

cases, cause an allergic reaction in the

patient.

!

Large quantities (several units of blood)

of salvaged RBC transfusion have been

reported to cause coagulation abnormalities.

"

Disconnect the RBC bag from the system

prior to reinfusing the RBCs.

Any recovered blood product may contain

microemboli. Always reinfuse salvaged RBCs

through a standard transfusion filter.

Warning: The RBC bag contains a

small amount of air. DO NOT PRESSURE REINFUSE.

The disposable set is for singlepatient use only.

Operator safety warnings

"

Follow local standard operating procedure blood precautions when using the

OrthoPAT system, particularly when

changing the RBC bag, changing the

waste bag or cleaning a blood spill.

"

Do not use the OrthoPAT system in the

presence of flammable anesthetics.

"

Do not touch rotating parts or open the

instrument to expose the electronics.

"

Attach the OrthoPAT system only to

appropriately grounded electrical

outlets.

Recommendations

The following recommendations may

improve the performance of the OrthoPAT

system:

"

Maintain suction levels as low as

possible to reduce RBC damage as the

shed blood travels through the suction

tip to the reservoir.

Note: The recommended intraoperative suction setting is –150 mm Hg

(–20 kPa; –200 mbar) or less.

Higher suction levels increase the

amount of RBC hemolysis.

The OrthoPAT system is designed for use

only with compatible OrthoPAT disposable

sets.

P/N 85252-30, Manual revision B

Page 16

2-4

"

"

"

"

OrthoPAT - Clinical Use

Avoid suctioning bone chips and bone

cement into the reservoir, as they may

lyse cells, occlude the suction lines or

clog the filter.

Avoid suctioning water and non-isotonic

solutions into the reservoir as this will

lyse the collected RBCs.

Avoid suctioning calcium-containing

solutions into the reservoir as this may

activate platelets.

Suction large volumes of irrigation solutions into a separate waste reservoir.

Note: Concentrating large volumes of

low hematocrit fluid from the

surgical site increases the procedure

time with a very low yield of RBCs.

"

Assure adequate anticoagulation.

Note: Excess anticoagulant is washed

out by the system.

"

Do not suction blood into the OrthoPAT

system during cement application.

Resume salvage once the wound site has

been irrigated.

It remains the responsibility of the surgeon

to determine how frequently to reinfuse

recovered processed blood or, if during a

prolonged surgery, the risk of sepsis

warrants discontinuation of intraoperative

recovery or changing the intraoperative

salvage devices’ disposable.

For more detailed recommendations please

consult local standard operating procedure.

P/N 85252-30, Manual revision B

References

Lake CL, Moore RA, eds. Blood hemostasis,

transfusion, and alternatives in the perioperative period. New York: Raven Press, 1995.

Petz LD, Swisher SN, Kleinman S, Spence

RK, Strauss RG, eds. Clinical practice of

transfusion medicine. Third Edition. New

York: Churchill Livingstone, 1996.

Salem MR. Blood conservation in the surgical

patient. Baltimore, MD: Williams & Wilkins,

1996.

Guidelines for blood salvage and reinfusion

in surgery and trauma. Bethesda, MD:

American Association of Blood Banks, 1997.

Perioperative autologous transfusion.

Arlington, VA, Transcribed Proceedings of a

National Conference, American Association

of Blood Banks, 1991.

Page 17

Section 3

System Description

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

Base unit..................................................................3-2

Base internal components ...........................................3-7

Display unit ..............................................................3-7

Disposable set ............................................................. 3-10

Intra-op suction set ................................................. 3-10

Post-op suction set .................................................. 3-11

Processing set ......................................................... 3-12

Replacement RBC bags.............................................. 3-15

Replacement waste bags ........................................... 3-15

Additional intraoperative suction sets......................... 3-15

Additional postoperative suction sets ......................... 3-15

P/N 85252-30, Manual revision B

Page 18

3-2

OrthoPAT - System Description

Equipment

Base unit

The OrthoPAT equipment is designed to be

mounted onto the IV pole. It consists of

two units, which are connected by a permanently attached cord:

!

The base unit.

!

The display unit.

Figure 3-1 shows the base unit including

the deck, front and left side of the equipment. The components are described below.

Centrifuge

The OrthoPAT centrifuge performs two functions.

Both units are designed to prevent fluid

from reaching the internal electrical components. Electrical and dimensional specifications are detailed in Appendix A.

1.

2.

3.

4.

5.

14.

13.

6.

7.

8.

12.

11.

10.

9.

Figure 3-1: Base unit (front view)

1. Cover handle

2. Cover

3. Header arm

4. RBC sensor

5. Centrifuge

6. Centrifuge spill container ring

7. Effluent valve housing (outlet valve)

8. Cover lock

9. RBC bag pins

10. Reservoir brackets

11. Reservoir sensor

12. Reservoir level detector window

13. Reservoir vacuum port

14. Inlet valve housing

P/N 85252-30, Manual revision B

!

It spins the dynamic disk to separate the

RBCs from the waste product.

!

It also controls the volume of the separation chamber by applying either vacuum or air pressure to the outside of the

disk diaphragm.

See Appendix B for details on the operation

of the dynamic disk.

Air enters or leaves the centrifuge chuck

through a port below the centrally located

air diffuser. The air diffuser forces the air to

enter or leave from the bottom center of

the centrifuge chuck and protects the internal pneumatic system in case of a blood

spill. A series of internal pneumatic valves

and sensors control the air flow in the centrifuge. When the disk is properly seated,

the centrifuge pneumatic system can maintain a vacuum indefinitely and can generate

up to 3 psi (approximately 21 kPa;

207 mbar) of pressure in the centrifuge

chuck.

When the disk is seated in the centrifuge,

the D-ring seals it to the centrifuge chuck.

The disk is further held in place by the

retainer ring.

Air pressure or vacuum generated by the

pneumatic system deflects the diaphragm

to change the disk volume and to control

the size of the separation chamber.

Page 19

OrthoPAT - System Description

3-3

The centrifuge chuck allows the disk to

expand to a maximum capacity of approximately 100 ml. Figure 3-2 shows a detail of

the centrifuge, and disk/centrifuge interface.

A.

B.

C.

1.

2.

3. 4.

Figure 3-2: Centrifuge and disk interface

A. Centrifuge chuck

B. Rotating disk components

C. Stationary disk components

1.

2.

3.

4.

Diaphragm

Hollow centrifuge motor shaft

D-ring

Retainer ring

The centrifuge speed range is from 0 to

5500 rpm. The centrifuge speed is controlled and monitored by the system controller, and varies during the processing

cycle.

The centrifuge motor and drive interface are

sized such that there is not sufficient power

in the system to spin the centrifuge at a

dangerously high speed.

Diffuser cap

(not shown in Figure 3-1)

The diffuser cap forms the airflow pathway

used to move the diaphragm of the dynamic

disk during the fill or empty phases of the

processing cycle. It is a white cap that

makes up the center portion of the centrifuge chuck.

The diffuser cap captures a hydrophobic filter and gasket that prevent fluid from

reaching the internal pneumatics in the

event of a blood spill. The cap is screwed

down into place and should be finger tight

at all times. For removal and/or replacement of these parts refer to Section 7 of

this manual.

Centrifuge spill containment ring

In the event of a fluid spill in the centrifuge, the centrifuge spill containment ring

contains the blood in the centrifuge area.

The ring can be removed easily to clean the

centrifuge. See Section 7 for cleaning

instructions.

Cover

The cover is translucent to allow the operator to observe the blood processing. It prevents debris or spilled fluids from falling

into the spinning disk and protects the

operator from accidental contact with

rotating parts. Its primary function is to

prevent any blood or parts of the disk from

exiting the centrifuge if a disk should fail

during operation. There are notches in the

cover to accommodate the tubing that connects the components underneath to the

bags and reservoir located outside the

cover.

Cover lock

The cover lock ensures operator safety by

keeping the cover closed whenever the centrifuge is spinning. A sensor incorporated

into the cover lock verifies the cover lock

status to the controller. When the system is

powered off while the disk is spinning, the

cover will remain locked until the disk has

come to a complete stop. A manual override

allows the cover lock to be released. See

Section 6 for details.

P/N 85252-30, Manual revision B

Page 20

3-4

OrthoPAT - System Description

Effluent valve (outlet valve)

RBC sensor

The effluent valve controls the three-port

effluent stopcock (outlet stopcock) which

is a component of the disposable set. The

valve turns the stopcock to divert fluid

exiting from the disk into either the waste

bag or the RBC bag. It also has an off position which prevents flow of fluid out of the

disk.

The RBC sensor is an optical sensor which

detects when RBCs are exiting the disk. It

determines when to stop expressing waste

into the waste bag and begin the wash

cycle. It then determines when to stop

expressing wash into the waste bag and

express the washed, concentrated RBCs into

the RBC bag.

Header arm

Reservoir brackets

The header arm holds the header portion of

the disk stationary during operation. The

arm is located on the rear of the deck and

folds forward into place. It contains the

RBC sensor and positions the sensor appropriately on the disk header.

The reservoir brackets hold the reservoir in

place during operation. They mate to tabs

on the disposable reservoir which is loaded

onto the system by sliding it down the side

of the base unit and into the reservoir

brackets. The reservoir brackets assure that

the reservoir is appropriately positioned for

the system to accurately monitor the volume of fluid collected in the reservoir.

The header arm locks into place when it is

lowered onto the header. To remove the

disk, slide the latch on the back of the arm

forward and fold the arm up and back.

Inlet valve

The inlet valve controls the three-port inlet

stopcock which is a component of the disposable set. The valve turns the stopcock to

allow either blood from the reservoir, or

rinse solution from the saline bag, to enter

the disk. It also has an off position which

prevents flow of fluid into the disk.

RBC bag pins

The RBC bag hangs on the pins on the front

of the system.

P/N 85252-30, Manual revision B

Reservoir level detector window

The reservoir level detector determines the

level of fluid in the reservoir. The reservoir

level detector window on the side of the

system allows the internal camera to monitor the level of a float ball located in a

channel of the disposable reservoir. An

internal light source illuminates the channel and may cause a visible glow inside the

reservoir.

Reservoir sensor

A microswitch sensor on the side of the

OrthoPAT system detects that the reservoir

is in place.

Page 21

OrthoPAT - System Description

Reservoir vacuum port

A pneumatic connector on the disposable

reservoir fits into the vacuum port to create

a passage for air flowing in and out of the

reservoir. During intraoperative operation,

the port connects to the external wall suction through the wall suction connector on

the back of the OrthoPAT system. When the

system is used for postoperative autotransfusion, the port connects to the OrthoPAT’s

internal pneumatic system.

3-5

Figure 3-4 shows the rear and right side of

the base unit. The components are

described below.

1.

2.

10.

Retainer ring

The retainer ring illustrated in Figure 3-3 is

used to secure the disk in the centrifuge

chuck. Once the disk is seated in the centrifuge, the retainer ring is fitted between the

top of the disk and the lip of the centrifuge. It is removed by gently pulling toward

the center of the disk and upward.

Figure 3-3: Retainer ring

Note: The retainer ring is NOT disposable. Replace the retainer ring only

if damaged or warped.

3.

9.

4.

8.

5.

11.

7.

6.

Figure 3-4: Base unit (rear view)

1. Reservoir vacuum port

2. Battery charge indicator light

3. IV pole clamp

4. Fan

5. Wall suction connector

6. Power cord connector

7. Cable to display unit

8. Power switch

9. Waste bag pins

10. Display unit support post

11. Spill collection bag tray

Battery charge indicator light

The battery charge indicator light informs

the operator that the system battery is

charging. The green light will remain illuminated whenever the system is connected to

AC power, regardless of power switch position.

P/N 85252-30, Manual revision B

Page 22

3-6

OrthoPAT - System Description

Display unit support post

The display unit support post fits into a

hole in the rear of the display unit to allow

the display unit to be mounted directly

onto the base unit. When not in use, the

display support pole rotates flush with the

back of the unit.

Fan

The fan maintains an appropriate operating

temperature in the unit by pulling air in

from a vent in the front of the cabinet

through the base unit and pushing it out

through the fan. The front vent is filtered

to prevent dust and debris from being

pulled into the instrument.

IV pole clamp

The IV pole clamp allows the base unit to

be mounted on a round IV pole of 22

to 32 mm (7/8 to 1 1/4 inches) diameter,

or square poles of 20 to 25 mm.

The system should be stored with the power

cord plugged in, to charge the battery. The

power switch does not have to be turned on

for the battery to charge.

Wall suction connector

The wall suction connector allows a vacuum

line to be attached to the operating room

wall suction. Air moves through the system

to create suction in the reservoir and at the

suction tip during intraoperative operation.

The wall suction connector accommodates

vacuum tubing with an internal diameter

range from 6.25 to 10 mm (0.250 to

0.375 inches).

The OrthoPAT system has an internal valve

that closes off wall suction whenever intraoperative suction is not in use.

Waste bag pins

The waste bag hangs on the right side of

the system on the waste bag pins.

Power cord

Spill collection bag tray

The power cord is a hospital-grade, 3-wire

with ground connection cable that connects to the system base with a universal

connector. A strain relief cover holds the

cord in place to prevent inadvertent separation from the base unit.

The spill collection bag tray is part of the

centrifuge drain system. The spill collection

bag tray contains the drain tube attached

to the base unit and the spill collection

bag.

Power switch

The power switch turns the system on and

off. When the switch is turned off, all procedure data is erased, and the system performs a power down procedure to assure

that the system shuts down safely and

appropriately.

Note: Do not turn off the power

switch to change between battery

and AC power operation; simply

unplug the power cord.

P/N 85252-30, Manual revision B

Note: Not all OrthoPAT systems

include a spill collection bag.

Page 23

OrthoPAT - System Description

3-7

Base internal components

Power supply

There are several key internal components

in the base unit which are not visible from

the outside. They are described below.

The power supply accommodates worldwide

voltage and frequencies from 100 to 240 V

and 50 to 60 Hz, and meets all relevant regulatory requirements for medical devices.

Fuses protect the electrical system and can

only be changed by an authorized service

representative.

Battery

Whenever the system is disconnected from

AC power, battery power allows the system

to continue operation. The display dims and

indicates that the system is operating on

battery power. An audible signal indicates

that the system has changed between AC

and battery power.

The system must charge for approximately

4 hours in order to maintain a battery life

of approximately 30 minutes.

The system warns the operator when the

battery is low, before the battery runs out

of power. While operating on battery power,

the system maintains suction, volume

accounting, and all other normal operation;

however, the battery will not run the centrifuge or process blood.

Display unit

The display unit is attached to the base

unit through a permanently attached coiled

cable. The display unit contains all of the

operator interface components. Figure 3-5

shows the front and back of the display unit

and identifies the major components. The

components are described below.

A.

When the system is connected to AC power,

whether it is turned on or off, the battery

automatically recharges. The nickel metal

hydride battery pack can be replaced only

by an authorized service representative.

INTRA-OP

RUN

B.

Suction

Alarm Mute

Process

POST-OP

STOP

Controller

All operation of the system is controlled by

an integral microprocessor based controller.

An independent “watchdog” timing circuit

assures safe shut down of the system

should the controller malfunction.

Pneumatic system

The internal pneumatic system consists of a

vacuum tank, compressor and a variety of

valves and sensors.

1.

2.

3.

4.

5.

Figure 3-5: Display unit

A.

1.

2.

3.

Front view

Display

Keyboard

Cable to base unit

B. Back view

4. IV pole clamp

5. Hole for mounting on base unit

P/N 85252-30, Manual revision B

Page 24

3-8

OrthoPAT - System Description

Display

!

Volume graph: This portion of the display shows a bar graph of the cumulative

filtered volume collected into the reservoir in either INTRA-OP or POST-OP

mode.

The bar graph in the INTRA-OP mode is

different from the bar graph used in the

POST-OP mode. The Intra-op graph shows

total filtered volume, while the Post-op

graph shows the filtered volume collected vs. time where each bar is a halfhour period.

!

Message area: Any messages to the

operator to call attention to an event or

error are displayed in this portion of the

display. Up to three lines of text can

appear in this area.

!

Icons: Icons at the bottom of the screen

indicate power and alarm status.

The display provides the operator with clinical and operational information about the

OrthoPAT system operating status. The

organization of the display is illustrated in

Figure 3-6.

INTRA-OP Run

1.

Time: 4 Hrs 43 Mins

Process Until Empty

Volume: 355 ml

2.

3000

2500

2000

ml

1500

1000

500

3.

Close cover.

4.

Cover not locked.

Press Alarm Mute to continue.

POST-OP Volume: 345 ml

5.

6.

Operating on battery power

Figure 3-6: Display organization

1.

2.

3.

4.

5.

6.

Mode of operation

Total box

Volume graph

Message area

Icons

Previous volume

Battery power running low

Alarm mute active

Operating on AC power

!

!

Mode of operation: The current mode of

operation appears at the top of the display.

Total box: The total box shows the total

elapsed time and total filtered volume

collected in the current mode of operation. It also alerts the operator about

any active suction or processing overrides.

P/N 85252-30, Manual revision B

!

Previous volume: The display always

shows the filtered volume collected in

the non-active mode of operation. For

example, when the system is in the

POST-OP mode, the previous volume

shows the total Intra-op filtered volume

collected.

Page 25

OrthoPAT - System Description

3-9

Keyboard

The light on the key is displayed when

Alarm Mute is active and the system displays the alarm muted status on the display panel. Some alarms sound a single

time to alert the operator that a message is on the display. Alarms which continue to sound require operator

intervention.

The keyboard is a sealed membrane panel

with easy-to-press keys. All keys have integral lights to indicate when they are operating, and a tone sounds to indicate when a

key has been pressed. The keyboard is integrated into the display panel and includes

the following keys:

!

POST-OP: Places the system in the postoperative SALVAGE mode of operation

with suction for the reservoir coming

from the internal vacuum system and the

volume accounting set for postoperative

operation. The system is either in Intraop or Post-op operation, in a STANDBY or

RUN mode.

!

INTRA-OP: Places the system in the

intraoperative autotransfusion mode of

operation with suction for the reservoir

coming from the wall, and the volume

accounting set for intraoperative operation. The system is either in Intra-op or

Post-op operation, in a STANDBY or RUN

mode. The default mode on power-up is

INTRA-OP.

!

!

!

RUN: Starts operation of the automatic

cycle operation as either Intra-op or

Post-op according to the current mode of

operation. It activates both the suction

and process functions, and turns on the

key lights accordingly.

Suction: Pressing the Suction key once

toggles the suction on or off, whichever

is the opposite of the current operation.

The key light is on whenever suction is

on, and off when suction is off.

Alarm Mute: When pressed, the Alarm

Mute key mutes the sound of an active

alarm. The key resets automatically when

a new alarm condition occurs.

!

Process: Pressing the Process key once

toggles the Process function on or off,

whichever is the opposite of the current

state of operation.

Double-clicking the Process key causes

the system to process the volume in the

filtered side of the reservoir until that

side of the reservoir is empty. The Process key light blinks whenever the system is in the Process Until Empty

function. Once the filtered side is

empty, the system returns to the previous run state.

!

STOP: Places the system in Intra-op or

Post-op STANDBY mode according to the

current mode of operation. It stops both

the suction and process functions.

IV pole clamp

The IV Pole clamp allows the display unit to

be mounted on a round IV pole of 22 to

25 mm (7/8 to 1 inch) diameter. The clamp

hinges around the pole and is tightened

with the large knob.

Base mount

If conditions prevent the display from

being mounted on the IV pole above the

base unit, it can be mounted by fitting it

onto the extended display support post on

the base unit.

P/N 85252-30, Manual revision B

Page 26

3-10

OrthoPAT - System Description

Disposable set

The OrthoPAT disposable autotransfusion

set is designed for single-patient use. The

autotransfusion set includes three components:

!

The processing set.

!

The Intra-op suction set.

!

8.

1.

2.

7.

6.

3.

The Post-op suction set.

5.

The suction sets are provided in a sterile

double bag, and the processing set is provided with a sterile fluid pathway.

All disposables are sterilized with either

gamma irradiation or ETO (specified on disposable label).

All disposable sets, RBC and replacement

bags are non-pyrogenic.

In addition to the autotransfusion set,

replacement RBC bags, waste bags, and

additional Intra-op and Post-op suction

sets are available. All disposable parts are

latex free.

Note: The configuration of the

tubing and/or packaging may differ

depending on geographic location.

4.

Figure 3-7: Example of an Intra-op suction

set

1.

2.

3.

4.

5.

6.

7.

8.

Suction tip connector

Anticoagulant Y

Aspiration line

Aseptic cap

Anticoagulant roller clamp

Anticoagulant line

Drip chamber

Anticoagulant spike

Intra-op suction set

Anticoagulant line

Figure 3-7 shows the Intra-op suction set

with each identified component described

below. This set is used to collect blood

intraoperatively from the surgical field. The

Intra-op suction set is packaged to allow it

to be delivered to the sterile field. The

Intra-op suction set is provided sterile and

non-pyrogenic for single-patient use.

The anticoagulant line is standard IV tubing

that runs between the anticoagulant bag

and the aspiration line to deliver anticoagulant to the shed blood. Anticoagulation of

intraoperative shed blood is necessary to

prevent blood from clotting prior to processing. Anticoagulant is not required in

postoperative operation.

Anticoagulant roller clamp

A roller clamp on the anticoagulant line

allows the operator to adjust the flow rate

of the anticoagulant.

P/N 85252-30, Manual revision B