Waters Medical Systems Oxicom 2100 User manual
Oxicom 2100
INSTRUCTION MANUAL
WATERS MEDICAL SYSTEMS
P.O. BOX 6117
IVD
Telephone: (800)-426-9877
EC REP
Caution: Federal law restricts this device to sale by or on the order of a physician.
REV 042006
WPN 0000707.000
ROCHESTER, MN 55901-6117
(507) 252-3784
Fax: (507) 252-3700
CEpartner4U BV
Esdoornlaan 13
3951DB; Maarn NL.
+31 (0) 6-516.536.26
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WATERS MEDICAL SYSTEMS
Customer Service
Waters Instruments provides toll-free telephone support to assist you with questions both
technical and non-technical. Most problems can be diagnosed over the phone; however, if
a representative needs to be called we can assist you. The toll-free number is also used to
order instruments, parts, disposables and product information. Orders are also placed with
a purchase order sent in on the Fax number shown below. When calling with a technicalrelated question, ask for technical support and your call will be directed quickly. All other
questions can be directed to customer service.
Customer Service:
800-426-9877 (United States & Canada)
507-252-3784 (International calls)
507-252-3700 (Fax)
Returning Equipment
If we cannot resolve equipment problems over the phone, you may need to return your
instrument to Waters. All items to be returned must be issued a RMA (Return Material
Authorization) number in advance. This will prevent delays and possible refusal upon
delivery. All parcels should be shipped to our street address. Correspondence can be
sent to our post office box or use the Fax number above.
Parcels: Waters Medical Systems
Attn: Medical Systems RMA#
2112 15th Street NW
ROCHESTER MN 55901
Correspondence: Waters Medical Systems
Attn: Medical Systems
P.O. Box 6117
ROCHESTER MN 55903-6117
1
WATERS MEDICAL SYSTEMS
QUALITY POLICY
Provide products and services that meet our
customer's expectations, are defect free, and are
delivered on time.
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TABLE OF CONTENTS
SECTION TITLE PAGE
Customer Support......................................................................................1
1 General Information..................................................................................5
1.1 Introduction............................................................................................7
1.2 Benefits..................................................................................................7
1.3 Theory of Operation...............................................................................8
1.4 Accuracy Limitations.............................................................................8
2 Operating Controls..................................................................................11
2.0 Operating Controls...............................................................................13
2.1 Front Panel Controls............................................................................13
2.2 Back Panel Controls.............................................................................14
2.3 DC-80 Disposable Cuvette ..................................................................14
3 Operating Instructions............................................................................15
3.1 Sample Preparation & Blood Handling ...............................................17
3.2 Power On & Warm-up.........................................................................19
3.3 Quality Control ....................................................................................20
3.4 O2 Saturation Mode..............................................................................28
3.6 Heparinize Cuvette...............................................................................30
4 Calibration................................................................................................31
4.1 Calibration Theory...............................................................................33
4.2 Blood Sample Preparation ...................................................................34
4.3 Determine Functional Oxygen Saturation ...........................................37
4.4 Calibration............................................................................................38
5 Maintenance .............................................................................................43
5.1 Maintenance Schedule.........................................................................45
5.2 Quality Control Filters - Cleaning .......................................................45
5.3 Sample Chamber Cleaning ..................................................................45
5.4 Factory Default Settings ......................................................................46
5.5 Error Codes..........................................................................................48
5.6 Erroneous Readings.............................................................................51
6 Appendix...................................................................................................54
Oxicom-2100 Specifications......................................................................56
Abbreviations.............................................................................................58
Equations....................................................................................................59
Worksheets.................................................................................................60
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4
SECTION 1
GENERAL INFORMATION
5
SECTION 1 GENERAL INFORMATION
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SECTION 1 GENERAL INFORMATION
INTRODUCTION
The Waters Medical Oxicom 2100
Whole Blood Oximeter is designed for today's
busy cardiac catheterization laboratory
requirements and standards. The Oxicom 2100
will provide accurate, repeatable saturation
measurements in less than ten seconds.
The Oxicom 2100 optically measures the
light absorption of the blood to measure
functional oxygen saturation. Blood is infused
into a safe, convenient, single-use, disposable
cuvette. No special cleaning solution, calibrator,
or tubing is required.
1.2 BENEFITS
The Oxicom 2100 uses the latest
fiberoptic technology and a solid state detector
to provide accurate and repeatable oxygen
saturations. In the oxygen saturation mode, the
Oxicom 2100 will provide results in less than 10
seconds.
Contact with blood and contaminated
waste products is virtually eliminated with the
Oxicom 2100. Blood samples are injected into a
sealed, single-use disposable cuvette which is
easily inserted into the sample chamber located
on the front panel. After the sample is measured,
the cuvette and syringe are disposed with other
hospital wastes.
CAUTION:
Be sure that the cuvette and syringe are
disposed of in a manner consistent with good
hospital practices for infectious materials.
The introduction of fiberoptic
technology has eliminated the need for
maintaining tubing or pumps with the Oxicom
2100. No zeroing or calibration solutions are
required.
The Quality Control (QC) filters
supplied with your Oxicom 2100 allows the user
to check the calibration of the Oxicom 2100.
The set of filters consist of one translucent
plastic filter (QCl), and two precision glass
filters (QC2 and QC3).
The optical densities of these filters are
stored in the unit's microprocessor. When
inserted into the sample chamber the Oxicom
2100 measures the optical density and compares
it to the value stored. If the optical densities
match the display will read a %Sat value. After
affirming that the Oxicom 2100 is calibrated,
the unit is ready to use.
Liquid control samples are also available
but can not be used to calibrate in place of
whole blood.
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SECTION 1 GENERAL INFORMATION
1.3 THEORY OF OPERATION
The Waters Oxicom 2100 is a Whole
Blood Oximeter with the capability to measure
functional oxygen saturation. The Oxicom 2100
measures functional oxygen saturation of a 0.5
ml sample of whole blood.
The Oxicom 2100 uses a silicon
photodetector and light emitting diodes (LED)
mounted in a sealed housing within the
instrument. The blood sample is contained in an
optically clear, disposable cuvette. The bloodfilled cuvette is inserted through the front of the
instrument into the sample chamber housing.
BLOOD IS NOT INFUSED INTO THE UNIT.
The optical density of the sample is
measured using two pulsed LEDs and one
photodiode. The Oxicom 2100 system is
designed to pulse on the infrared (IR) LED, and
measure the optical density at 805 nm
(nanometers). Alternately, the red LED is turned
on and measures the optical density at 660 nm.
The photodiode converts the light transmitted
through the blood filled cuvette into a current
proportional to the amount of incident light. The
current is processed by the microprocessor and
the functional %O2SAT is calculated by the
Oxicom 2100.
The amount of IR light absorbed by the
blood is relatively independent of the blood's
oxygenation. However, RED light absorption or
optical density , is strongly dependent on the
oxygen saturation. The ratio of the optical
densities at the two wavelengths is used to
calculate the functional oxygen saturation.
1.4 ACCURACY LIMITATIONS
LIPID SAMPLES:
Lipid (fat) particles in a blood sample
may distort the normal light scattering
and cause erratic readings.
HEPARIN AND SALINE:
Excess heparin and saline dilutes and
lowers the hemoglobin of the sample.
This artificially raises the percent
saturation reading of the sample and can
cause separation which further raise the
percent saturation reading. Experience
indicates samples with 10% or more
liquid heparin or saline will affect the
reading. Prior to withdrawing a sample
of blood from any arterial line, the
operator should aspirate 3-5 cc of blood
from the line to remove any residual
heparin or saline.
AIR BUBBLES:
Care should be taken to prevent
oxygenation of the sample, always point
the syringe and cuvette up. If micro
bubbles are present, the oxygen
saturation of the sample tends to rise 12%.
INTERFERING DYES:
Indocyanine (Cardio) Green, Evans Blue
and Methylene Blue dyes absorb light at
the same frequencies as blood. The
presence of these dyes will effect oxygen
saturation readings of the Oxicom 2100.
Studies using interfering dyes must be
run after blood samples have been taken
to avoid erroneous readings.
OLD BLOOD SAMPLES:
Inserting the cuvette into the sample
chamber within 10 minutes is
recommended. If a delay is anticipated
and clotting may begin, the syringe
should be pre-coated with heparin.
CUVETTE HANDLING:
Care must be taken not to contaminate
the optical path of the cuvette. Do not
reuse cuvettes or the white plugs. Do not
lay the cuvette on edge; this will
increase the chance of blood separation.
The clear sampling area should be laid
face down.
CARBOXYHEMOGLOBIN and
METHEMOGLOBIN:
The Oxicom 2100 is an oximeter which
uses two wavelengths to determine the
Functional Oxygen Saturation. Two
wavelength oximeters such as the
Oxicom 2100 cannot determine the
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SECTION 1 GENERAL INFORMATION
amount of carboxyhemoglobin or
methemoglobin. They can only
determine the percentage of
oxyhemoglobin as it relates to the total
hemoglobin available for oxygenation.
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SECTION 2
OPERATING CONTROLS
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SECTION 2 OPERATING CONTROLS
Oxicom 2100 Front Panel
Operating Controls
Figure 2.1
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SECTION 2 OPERATING CONTROLS
2.0 OPERATING CONTROLS
This section describes the controls, displays and
markings on the Oxicom 2100.
2.1 FRONT PANEL CONTROLS
DISPLAY: The measurement display consists
of a three character display with two
decimal points. Whenever the decimal
points alternate positions the Oxicom
2100 is processing information. The
display provides the user with the
following information.
WRM - WaRM-up indicates that the Oxicom
2100 is in the timed 15 minute warm-up
period.
RDY - ReaDY indicates the Oxicom 2100 is
ready to accept blood samples. If the unit
has been turned off and on again, you
may bypass the warm-up by waiting 10
seconds and pressing START.
INS - INSert instructs the operator to insert the
cuvette.
RMV - ReMoVe, instructs the user to remove
the cuvette or Quality Control Filters
from the sample chamber.
ER1 - ER9 & ERa - ERe - ERror Codes l - 9
and a - e indicate the Oxicom 2100 was
unable to measure the blood samples.
Refer to Section 5.4 for more
information.
* - The * symbol followed by any number
indicates that the %SAT value to be
displayed exceeds 99.9%. Example: If
the display reads *2.4 the actual value is
102.4.
Decimal Point - The two decimal points on the
display indicate the magnitude of the
reading and will alternately flash at one
second intervals during balancing and
calibration.
%Sat - % Saturation. The %SAT will light only
when the mode switch is in the O2SAT
position. The display shows the
functional oxygen saturation value of the
blood sample.
CAL - The CALibration indicator will be lit
when the operator has entered the
calibration menu. Refer to the calibration
instructions Section 4.
START - The START button is used to initiate
blood sample measurements in
saturation mode. START also places the
Oxicom 2100 in the calibration mode
when depressed and the POWER switch
is turned on.
Arrow Switches - The Up/Down Arrow
switches are functional only in the
calibration mode. In the calibration
mode, the operator will use the Arrows
to adjust the displayed value to the
correct functional saturation.
Sample Chamber - The disposable cuvette is
inserted into the sample chamber. The
display directs the user to INSert the
cuvette. DO NOT INJECT BLOOD
INTO THE SAMPLE CHAMBER.
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SECTION 2 OPERATING CONTROLS
Oxicom 2100 Back Panel
Operating Controls
Figure 2.2
2.2 BACK PANEL CONTROLS
POWER - Switch applies AC power to the
Oxicom 2100. When the Oxicom 2100 is
turned On all the indicators on the front
panel will do a self test. "WRM" will be
displayed when completed.
POWER INPUT: Detachable AC power cord
connection.
2.3 DC-80 DISPOSABLE CUVETTE
The DC-80 cuvette is used to hold the
blood sample. It is a disposable single use
device. Do not reuse the cuvettes or filters. The
cuvette has a top and a bottom, a small panel
indicates bottom and should always be inserted
into the Oxicom downward. The porous filters
come with the cuvettes and are to be mounted
on the short neck of the cuvette. The filters
allow air to pass through when the cuvette are
being filled with blood, and prevent blood from
spilling from the tip of the cuvette. The filters
are also called cuvette caps, caps, or plugs.
Position panel facing down.
Disposable Cuvette and Porous Filters
Figure 2-3
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SECTION 3
OPERATING INSTRUCTIONS
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SECTION 3 OPERATING INSTRUCTIONS
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SECTION 3 OPERATING INSTRUCTIONS
3.1 SAMPLE PREPARATION AND
BLOOD HANDLING
The Oxicom 2100 requires less than 0.5 cc
of blood to measure blood oxygen saturation.
The blood sample is withdrawn into a syringe.
A disposable cuvette with filter is placed on the
syringe. Blood is then infused into the cuvette
and the cuvette is inserted into the Oxicom 2100
sampling chamber. Syringes and cuvettes are
discarded after the sample has been measured.
The disposable Oxicom 2100 cuvettes are
not heparinized. Therefore, the user must take
the necessary precautions to prevent the blood
sample from clotting. If the oxygen saturation of
the blood sample is going to be determined
within ten minutes of withdrawing, no heparin is
required. If the sample is to be used for
calibration of the Oxicom 2100, heparin is
recommended, refer to Section 3.7.
For proper measurements, calibration and
personal safety, it is essential that you follow
these steps consistently.
HELPFUL HINTS:
All samples should be measured within
ten minutes of withdrawal. The sooner the
samples are measured the less likely the blood
cells will separate.
Evacuate any air bubbles that remain in
the syringe before mounting the cuvette. Air
bubbles within the cuvette may alter the reading,
especially during calibration.
Inspect the cuvette for cleanliness prior
to use. Do not touch the sampling area (the clear
surface) of the disposable cuvette. Handle the
cuvette by their edges or tips.
Do not allow the cuvette to lie on the
edge. Position the cuvette on the syringe so that
when laid down, one of the cuvette side's face
down. This will minimize any cell separation
that may occur if the sample is not measured
after withdrawal.
Place the porous filter (white plug) onto
the disposable cuvette before infusing the blood
from the syringe, except when calibrating the
Oxicom 2100.
Do not force the blood sample into the
cuvette. If a resistance is felt, discard and try
another cuvette and filter.
Do not allow the filters to come in
contact with any fluid prior to mounting on
cuvette.
Do not reuse cuvettes or white plugs.
The sample must be mixed prior to
inserting into the Oxicom 2100.
Samples diluted with saline or heparin
will cause erroneous readings. All residual
saline or heparin must be removed from the line
before aspirating into the sample syringe.
Cardiogreen dye and other dyes will
affect the oxygen saturation reading. All
saturation measurements must be made before
dye injections are made.
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SECTION 3 OPERATING INSTRUCTIONS
SUPPLIES:
Disposable cuvette, one for each sample.
Porous filter, one for each cuvette.
Syringe, one for each sample.
Tissues or 4x4 gauze.
PROCEDURE
1. Prepare the cuvette and filters by mounting
the filters onto the short end of the cuvette.
Bottom panel
(Always position down)
2. Flush or withdraw enough blood from the
patient line in order to remove any saline. If the
line is not properly flushed the sample will be
contaminated and poor readings will result.
4. Mount and secure the long end of the
cuvette onto the syringe.
5. Holding the cuvette and syringe vertically,
slowly infuse the blood into the cuvette. Do not
allow any air bubbles to adhere to the internal
surface of the cuvette. Gently tap the cuvette if
bubbles begin to develop.
6. The sample should be mixed by rolling the
syringe between your hands in a horizontal
position.
7. Proceed to Section 3.2 for instructions on
measuring a blood sample.
3. Withdraw 1 to 2 cc of blood from the line
into the syringe. Evacuate any air bubbles that
may be in the sample . If necessary, gently tap
the syringe to knock any air bubbles loose.
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