BC Biomedical FingerSim User Manual

INSTRUCTION AND SERVICE MANUAL
BC BIOMEDICAL FINGERSIM PULSE OXIMETER TEST SYSTEM
BC Biomedical
BC Group International, Inc.
St. Louis, MO 63125
PROBLEMS?
Check Section XII
“Trouble Shooting Chart”
then, if still troubled call:
BC Biomedical Customer Support
800-242-8428 314-638-3800
FAX 314-638-3200
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CONTENTS
I. GENERAL WARNINGS AND CAUTIONS………..……..3
II. PURPOSE..............................................................................3
III. DESCRIPTION .....................................................................4
IV. THEORY OF OPERATION .................................................5
V. CONDITIONS THAT AFFECT USE ...................................7
A. Ambient Temperature ....................................................7
B. Movement Artifact.........................................................8
C. Sensor Alignment and Position ......................................8
VI. CHECK OUT.........................................................................8
VII. OPERATING INSTRUCTIONS..........................................9
A. Insert the FingerSim into the Holder ..........................9
B. Attach the Sensor ...........................................................9
C. Quiescent Test................................................................9
D. Oxygen Saturation Test..................................................9
E. Pulse Rate Test...............................................................9
F. Pulse Amplitude Test ...................................................15
VIII. SPECIFICATIONS ..........................................................11
A. FingerSim ................................................................11
B. Holder ..........................................................................11
IX. SERVICE AND MAINTENANCE .....................................12
X. WARRANTY ......................................................................12
XI. ACCESSORIES...................................................................12
XII. TROUBLE SHOOTING CHART......................................13
FIGURES
Figure 1. FingerSim ......................................................................... 4
Figure 2. Replacement Holder............................................................. 4
Figure 3. 80% SpO2 Absorption Spectrum......................................... 6
Figure 4. 90% SpO2 Absorption Spectrum......................................... 6
Figure 5. 97% SpO2 Absorption Spectrum......................................... 6
Figure 6. 80% SpO2 Temperature Dependence .................................. 7
Figure 7. 90% SpO2 Temperature Dependence.................................. 7
Figure 8. 97% SpO2 Temperature Dependence.................................. 8
Figure 9. Sensor Cable Routing Through Holder................................ 8
Figure 10. Positioning the FingerSim in the Holder.......................... 9
Figure 11. Sensor Cable Routing Through Holder.............................. 10
Figure 12. Generating a Simulated Pulse ............................................ 10
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I. GENERAL WARNINGS AND CAUTIONS
CONTRAINDICATION: Do not use with reflectance or ear clip sensors. Use only with transmittance type, finger or toe sensors.
WARNING: FingerSims are fragile and must be handled with care, they contain glass.
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
CAUTION: The movement of the FingerSim relative to the oximeter sensor may cause erroneous pulse rate
and/or oxygen saturation readings. Use the FingerSim Holder to facilitate pulse generation
without introducing FingerSim™ movement relative to the oximeter sensor.
CAUTION: Do not use a FingerSim that is cracked or leaking fluid.
CAUTION: Avoid extended exposure to sunlight.
CAUTION: The SpO2 simulation by the FingerSim is temperature dependent. See Charts 6, 7 and 8 for the
appropriate adjustment. Allow at least one-hour stabilization at room temperature before using.
CAUTION: Do not store the FingerSim outside the recommended Long Term Storage Temperature range
(32°F-104°F). NOTE: Temperatures outside this range for short duration are acceptable (for
example during shipping).
CAUTION: When testing flexible sensors, ensure the emitter and detector are vertically aligned on opposite
sides of the FingerSim.
CAUTION: Do not use beyond the calibration date.
CAUTION: No test system can simulate all possible operating conditions a pulse oximeter may encounter. Use
the FingerSim as an adjunct to other indications to determine proper pulse oximeter operation.
CAUTION: Improper insertion of the FingerSim into the Holder can cause breakage. Insert the Phantom as
shown in Figure 7.
II. PURPOSE
The FingerSim Pulse Oximeter Test System enables the healthcare professional to evaluate pulse oximeter and sensor function at three simulated light absorption conditions. These absorption conditions are set to simulate a typical finger at nominally 97%, 90%, and 80% SpO
pulse amplitudes and rates can be simulated.
Before the availability of the BC Biomedical FingerSim, pulse oximetry systems (oximeter plus sensor) were not easily tested. The oximeter’s measurement of the small pulsatile blood component and the interrelationship of the oximeter calibration curve with the light emitting characteristics of the sensor made a true oximeter system tester difficult to conceive. The BC Biomedical FingerSim System, when used as an adjunct to other indicators, aids the healthcare professional in assessing performance of both oximeter and sensor.
CONTRAINDICATION: Do not use with reflectance or ear clip sensors. Use only with transmittance type,
finger or toe sensors.
CAUTION: No test system can simulate all possible operating conditions a pulse oximeter may encounter. Use
the FingerSim as an adjunct to other indicators to determine proper pulse oximeter operation.
levels. In addition, a pulse oximeter’s response to various
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III. DESCRIPTION
The BC Biomedical FingerSim system provides a rapid, inexpensive and convenient means of assessing the function of the entire pulse oximeter system including the oximeter sensor. A set of three FingerSims are included in each kit. Each of the three FingerSims contain a fluid with precisely controlled light absorption characteristics sandwiched between two glass slides. The concentration of the substances in the three mixtures allow the FingerSim™ to mimic the light absorbing qualities of arterial blood as measured by an oximeter at different oxygen saturation values (nominally 97%, 90%, and 80%). The 97%, 90%, and 80% FingerSims are easily identified by the color coded end caps (Red - 97%, Blue - 90%, and Black - 80%).
Squeezing the colored coded flat end will produce a pulsatile movement of the solution. This pulsation is detected as a pulse by the oximeter system being tested, and thus allows the oximeter to calculate and display an SpO
value
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which corresponds to the fixed light absorbing characteristics of the particular FingerSim being used.
Figure 1. BC Biomedical FingerSim™
A holder is provided to stabilize the FingerSim™ while the pulsatile movement of the internal solution is generated.
Figure 2. BC Biomedical Replacement Holder
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