Clinical Dynamics: SmartSat SpO2 Simulator / Tester

Oxygen Saturation (SpO2)

Range: 0-100 SpO2%

Resolution: 1 SpO2%
±0.5 SpO2%, 70-100 SpO2%
Accuracy:
±1 SpO2%, 50-69 SpO2%

Pulse Rate

Range: 20-300 BPM

Resolution: 1 BPM
±1 BPM, 20-199 BPM
Accuracy:
±2 BPM, 200-300 BPM

R-Curves (Red/IR Ratio)

R-Curves specify the relationship between the Red/IR ratio measured by pulse oximeters and
the SpO2 value displayed . R-curves are obtained by each pulse oximeter manufacturer during
clinical trials.

Preset Manufacturer's R-Curves (14): BCI, Criticare, CSI-Spot, Datascope, Datex, Hewlett-
Packard, Masimo, Nellcor, Nellcor OxiMax, Nihon Kohden, Nonin, Novametrix, Ohmeda &
Sensormedics

Comprehensive Parameters

Pulse Modulation Amplitude - Simulates the effect of tissue perfusion

Ambient Light - Simulates the ambient light level "seen" by the oximeter probe
Motion Artifact – Simulates motion artifact
Arrhythmias - Simulates arrhythmias by altering the pleth pulse amplitude and pulse rate.
Auto Sequences - Preset Auto Sequences automate pulse oximeter testing.
Standard Presets – 18 Presets
 Clinical Dynamics: SmartSat Probe Test Theory

Understanding Pulse Oximeter Probes

A pulse oximeter probe contains 2 LED’s (light emitting diodes) and
one photo-diode. One LED emits red light and the other LED emits
infrared light. The LED’s shine light on one side of the patient’s finger.
The photo-diode (a light detector) is held against the other side of the
patient’s finger to measure the amount of light that is transmitted
through the patient’s finger. In operation the pulse oximeter alternately
sends current to the red LED, then to the infrared LED. They are not on at the same time. When
light from the red LED in the probe transmits through the patient’s finger, it strikes the photo-
diode on the other side of the probe. This light produces an electrical current through the photo-
diode. This is the red photo-diode current. When light from the infrared LED transmits through
the patient’s finger and strikes the photo-diode it produces the infrared photo-diode current. The
pulse oximeter measures both the red photo-diode current and the infrared photo-diode current.
The ratio of these currents indicates the oxygen saturation of the patient. There are two basic
variations of probe configuration. In one the RED and IR LEDs are wired in parallel with
opposite polarity. We call this a two circuit probe, the two LED’s share one circuit and the photo-
diode is in the second circuit. In the other variation, the RED and IR LEDs are wired in series
with opposite polarity. We call this a three circuit probe, the red LED circuit, the infrared LED
circuit, and the photo-diode circuit can all be considered separate from each other.

Common Problems with Probes:

One of the most common problems is that the electrical cable connecting the probe to the pulse
oximeter instrument can develop open or short circuits, or, intermittent open or short circuits.
This is caused by mechanical stress on the cable as it is used. Another problem that can
develop with probes is changes in the sensitivity. This is the amount of photo-diode current
produced by a given current through the LED. Sensitivity can degrade due to dirt on the lenses
or other damage to the probe.

SmartSat Probe Continuity Testing (Probe-C)

Probe continuity testing checks a pulse oximeter probe for opens or shorts in the cable or
connectors. A probe which shows as short or open after pressing center, or when the cable is
flexed, can be considered a problem. During the continuity test, SmartSat conducts the
appropriate current through the probe circuits and measures the voltage drop across the circuit.
Very low voltages are short circuits. Higher voltages indicate open circuits. The “good” range of
voltage is around 1 volt. To see the value press “Center”. The exact voltage level may vary a fair
amount between manufacturers and lots due to normal variations in individual diode
characteristic curves. We are looking for a reasonable forward bias drop.
 SmartSat’s Continuity Display
SmartSat displays the results of these voltage measurements on a
graphic display that looks like an oscilloscope or ECG display. There
is a separate display window for each probe circuit. SmartSat
automatically displays either two windows (LED and PHOTO) or three
windows (RED, IR, and PHOTO) based on which design the oximeter
manufacture uses in their probes. The vertical axis of the display
window is labeled “Open” at the top, “Good” in the middle, and “Short” at the bottom. As with an
oscilloscope, the horizontal axis of the display represents time. The trace moves across the
screen about once every 2 seconds. When a good probe is attached to SmartSat, the traces run
along the center of the display window, at a level corresponding to “Good”. When the trace
reaches the right side of the screen, it erases and restarts from the left side of the screen. This
repeats as long as the probe is attached to SmartSat. The sweep mode (SwpMode) can be
changed from repeat sweep (RptSwp) to single sweep (SglSwp). In single sweep mode the
trace will stop after detecting any short or open so the operator will see it. This will call attention
to an intermittent if the operator didn't notice it right away. The screen will remain frozen until the
operator presses the “Reset” control button. In general good probes of the same manufacturer /
lot will match within the center sets of dotted lines. This is approximately +/- 70 mV deviation.
Deviations of approximately twice that can be interpreted by SmartSat as short or open. Due to
the normal variations in diodes no absolute normal range values can be easily set for all cases.
In order to fully test a probe, the user should bend and flex the cable during the test.

Probe Sensitivity Testing (Probe-S)

SmartSat’s probe sensitivity test is a measure of a probe’s electro-optical performance. As
described earlier, current in the either LED produces a current in the photo-diode. The ratio of
these currents can be considered to be a current transfer ratio. This ratio is dependent on three
factors: the efficiency of the LED, the sensitivity of the photo-diode, and the optical path
between the LED and the photo-diode. After probes have been used for some time the current
transfer ratio can degrade due to degradation of the LED’s or the photo-detector, or, due to dirt
or damage on the lens surfaces. During the probe sensitivity test SmartSat sends a specific
level of current through each LED and measures the resulting current through the photo-diode.
The probe sensitivity display on the SmartSat shows the current transfer ratio for the RED LED
to the photo-detector, the current transfer ratio for the IR LED to the photo-detector, and the
RATIO of the RED ratio to the IR ratio. There are no absolute value ranges for good or bad but
testing several probes for a given manufacturer or lot should provide insight as to what a normal
sensor may read on this test and any that deviate significantly may not perform in use as
expected. Overall ratio changes of RED to IR (RATIO) may shift the SpO2 reading, while an
overall gain decrease ( both RED and IR low but RATIO good ) may be caused by dirt blocking
the light. Please note that ambient light sources can affect the results. Therefore it is
recommended to perform the sensitivity testing under somewhat repeatable lighting conditions,
such as testing a given batch all at the same work bench.
 Clinical Dynamics: Optical vs. Electrical Testing

Foreword:
Pulse oximeter manufacturers do not suggest the use of optical
simulators because of probe placement issues and the fact these are
not true optical simulators; they’re actually an electrically driven optical
light source. Let’s review what leading pulse oximeter manufacturers
use for testing:

Nellcor: The World’s Leading Pulse Oximetry Manufacturer

Nellcor suggests SmartSat™ to its OEM partners and provides its own Quick Check electrical
simulators. “Electrical simulation is the most accurate and controlled method of testing a pulse
oximeter. SmartSat is the only commercially available electrical SpO2 Simulator that tests
Nellcor Oximax technology. We suggest it to our OEM partners as our quick check electrical
simulators are designed for spot checks and are not designed for the needs of our OEM
partners.” OEM Support Manager, Nellcor

Masimo: The Leading Motion Tolerant Pulse Oximetry Manufacturer

Masimo includes SmartSat in its OEM Support Manual and also provides a quick check
electrical simulator. “We recommend electrical simulators to our OEM partners and SmartSat is
the electrical simulator specified in our OEM Product Support manual. Many of our OEM
partners use it for testing our Masimo MS-11 OEM SpO2 modules. Electrical simulation is the
most accurate method to test a pulse oximeter, we supply our own simple, quick check electrical
simulators.” OEM Engineering Support Manager, Masimo Corporation

Philips Medical Systems: The Leading Patient Monitoring Manufacturer

Philips uses SmartSat in product development, technical support and quality control /
production testing. "Clinical Dynamics' SmartSat SpO2 Simulator generates the cleanest,
lowest noise signals, and therefore provides the most accurate, reliable test results. With
SmartSat's electrical simulation method, you never have to worry about probe placement
introducing errors." Project Manager, SpO2 R&D, Philips Medical Systems

Datascope: OEM partner of Nellcor & Masimo

Datascope uses SmartSats for testing both Nellcor and Masimo’s OEM modules in
engineering, technical support and quality control for production testing. “Since 1996,
Datascope has been utilizing SmartSat for testing Nellcor and our own Datascope pulse
oximetry technologies used in a variety of our patient monitors. SmartSat was again suggested
to us by Masimo, when we became a Masimo OEM partner and we implemented additional
SmartSats for testing our monitors with Masimo pulse oximetry.”
Production Department Manager, Datascope Corporation.