Technical Description SpO2

Smiths Medical PM, Inc.
BCI® OEM Technologies
Technical Description
for
WW3711 Digital Micro Power
Oximeter Board
- English
Document Number 31402TEC2
Version 2, June 2008
©2007 Smiths Medical Family of Companies. All rights reserved.
Technical Description Smiths Medical PM, Inc. Digital Micro Power Oximeter Board 31402B2
Table of Contents Page

Warnings, Cautions, & Notes......................................................................4
1. Product Description...............................................................................7
2. Theory of Operation...............................................................................7
3. Product Specifications...........................................................................8
4. Serial Communications Specifications................................................11
4.1 Extended Micro Power Mode Communication Protocol...........12
4.2 Extended Micro Power Mode Host Control Signals.................13
4.3 Digital Micro Power Mode Communication Protocol..............13
4.4 Digital Micro Power Mode Host Control Protocol...................15
5. Dimensions/Pin Description................................................................16
6. Sample Host Software Subroutine.......................................................18
6.1 Extended Micro Power Mode....................................................18
6.2 Digital Micro Power Mode.......................................................21
7. Sensors..................................................................................................24
8. Checking Pulse Oximeter Performance................................................25
9. Response Time.....................................................................................25
10. Demonstration Software......................................................................26
11. Ordering Information...........................................................................26
Appendix A (Clinical Desaturation Testing).............................................27
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Proprietary Notice
Information contained in this document is copyrighted by Smiths Medical PM, Inc. and may not be duplicated
in full or part by any person without prior written approval of Smiths Medical PM, Inc. Its purpose is to
provide the user with adequately detailed documentation to efficiently install, operate, maintain, and order
spare parts for the device supplied. All information contained in this document is believed to be current and
accurate as of the date of publication or revision, but does not constitute a warranty.
Warnings, Cautions, & Notes

KEYWORD DEFINITION
WARNING Tells you about something that could hurt the patient or hurt the operator
CAUTION Tells you something that could damage the monitor
NOTE Tells you other important information
Warnings
WARNING: The Digital Micro Power Oximeter board is a NOT a stand alone device and it does NOT provide
any patient isolation. The Host system is responsible for providing proper patient isolation. Failure to
properly isolate the patient may result in injury or death.
WARNING: Do not use this device in the presence of flammable anesthetics; a spark hazard may exist which
may result in explosion.
WARNING: Do not use this device in the presence of magnetic resonance imaging (MR or MRI) equipment.
MRI equipment may cause induced current to the SpO2 sensor resulting in patient injury.
WARNING: Do not use this device in the presence of high EMI/RFI radiation. High EMI/RFI radiation may
cause induced current to the SpO2 sensor resulting in patient injury.
WARNING: This device may give inaccurate readings in the presence of strong electromagnetic sources,
such as electrosurgery equipment.
WARNING: This device may give inaccurate readings in the presence of computed tomography (CT)
equipment.
WARNING: This device must be used in conjunction with clinical signs and symptoms. This device is only
intended to be an adjunct in patient assessment.
WARNING: Prolonged use or the patient’s condition may require changing the sensor site periodically.
Change sensor site and check skin integrity, circulatory status, and correct alignment at least every 4 hours.
Prolonged use may cause blisters, skin deterioration, and discomfort.
WARNING: When attaching sensors with Microfoam® tape, do not stretch the tape or attach the tape too
tightly. Tape applied too tightly may cause inaccurate readings and blisters on the patient’s skin (lack of skin
respiration, not heat, causes the blisters).
WARNING: When connecting this monitor to any instrument, verify proper operation before clinical use.
Refer to the instrument’s user manual for full instructions. Accessory equipment connected to the monitor’s
data interface must be certified according to the respective IEC standards, i.e., IEC 950 for data processing
equipment or IEC 601-1 for electromedical equipment. All combinations of equipment must be in
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compliance with IEC 601-1-1 systems requirements. Anyone connecting additional equipment to the signal
input port or the signal output port configures a medical system, and, therefore, is responsible that the
system complies with the requirements of the system standard IEC 601-1-1.
WARNING: Incorrectly applied sensors may give inaccurate readings. Refer to the sensor insert for proper
application instructions.
WARNING: Using a damaged sensor may cause inaccurate readings, possibly resulting in patient injury or
death. Inspect each sensor. If a sensor appears damaged, do not use it. Use another sensor or contact
your authorized repair center for help.
WARNING: Using a damaged patient cable may cause inaccurate readings, possibly resulting in injury or
death. Inspect the patient cable. If the patient cable appears damaged, do not use it. Contact your
authorized repair center for help.
WARNING: Use only SpO2 sensors supplied with, or specifically intended for use with, this BCI oximeter.
Use of sensors not intended for use with this device may cause inaccurate readings. See section 7 for list of
approved sensors.
WARNING: SpO2 measurements may be inaccurate in the presence of high ambient light. Shield the sensor
area (with a surgical towel, for example) if necessary.
WARNING: Dyes introduced into the bloodstream, such as methylene blue, indocyanine green, indigo
carmine, patent blue V (PBV), and fluorescein may adversely affect the accuracy of the SpO2 reading.
WARNING: Any condition that restricts blood flow, such as use of a blood pressure cuff or extremes in
systemic vascular resistance, may cause an inability to determine accurate pulse rate and SpO2 readings.
WARNING: Remove fingernail polish or false fingernails before applying SpO2 sensors. Fingernail polish or
false fingernails may cause inaccurate SpO2 readings.
WARNING: Significant levels of dysfunctional hemoglogins, such as carboxyhemoglogin or

methhemoglobin, will affect the accuracy of the SpO2 measurement.
WARNING: Tissue damage may result from overexposure to sensor light during photodynamic therapy with
agents such as verteporphin, porfimer sodium and metatetrahydroxyphenylchlorin (mTHPC). Change the
sensor site at least every hour and observe for signs of tissue damage. More frequent sensor site changes
or inspections may be indicated depending upon the photodynamic agent used, agent dose, skin condition,
total exposure time or other factors. Use multiple sensor sites.
WARNING: Ethylene oxide sterilizing the sensor may lead to tissue damage when the sterilized sensor is
placed on a patient.
WARNING: Optical cross-talk can occur when two or more sensors are placed in close proximity. It can be
eliminated by covering each site with opaque material. Optical cross-talk may adversely affect the accuracy
of the SpO2 readings.
WARNING: Obstructions or dirt on the sensor’s red light or detector may cause a sensor failure or
inaccurate readings. Make sure there are no obstructions and the sensor is clean.
WARNING: When the board is placed in the High Sensitivity mode inaccurate readings may occur when no
finger is placed in the sensor.
WARNING: Specifications of accuracy are not valid when the board is in High Sensitivity Mode.
WARNING: Under certain clinical conditions, pulse oximeters may display dashes if unable to display SpO2
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and/or pulse rate values. Under these conditions, pulse oximeters may also display erroneous values.
These conditions include, but are not limited to: patient motion, low perfusion, cardiac arrhythmias, high or
small pulse rates or a combination of the above conditions. Failure of the clinician to recognize the effects
of these conditions on pulse oximeter readings may result in patient injury.
Cautions
CAUTION: Autoclaving, ethylene oxide sterilizing, or immersing the sensors in liquid may cause sensor
damage which may result in inaccurate readings.
CAUTION: This device is intended for use by persons trained in professional health care. The operator must
be thoroughly familiar with the information in this manual before using the device.
CAUTION: Unplug the sensor from the monitor before cleaning or disinfecting to prevent damaging sensor
or monitor, and to prevent user safety hazards.
Notes
NOTE: SpO2 averaging is the number of pulse beats over which the SpO2 value is averaged; pulse
averaging is the number of seconds over which the pulse value is averaged.
NOTE: Hazards arising from software errors have been minimized. Hazard analysis was performed to meet
EN60601-1-4 and EN14971.
NOTE: DESAT (human clinical desaturation) trails were performed in the normal sensitivity mode.
NOTE: Follow local, state, or national governing ordinances and recycling instructions regarding disposal
or recycling of the device and device components.
NOTE: Functional testers can not be used to assess the accuracy of a pulse oximeter probe or a pulse
oximeter monitor.
NOTE: Pulse oximeter equipment measurements are statistically distributed, only about two-thirds of pulse
oximeter equipment measurements can be expected to fall within ±Arms of the value measured by a CO-
oximeter.
The serial autocorrelation technology in this device is covered by U.S. Patent No. 5,558,096.
The Smiths design mark, BCI, and Comfort Clip are trade marks of the Smiths Medical Family of Companies. The symbol  indicates
the trademark is registered in the U.S. Patent and Trademark Office and certain other countries. All other names and marks mentioned
are the trade names, trademarks, or service marks of their respective owners.
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1. Product Description
The WW3712 Digital Micro Power OEM board is a satellite or daughter board capable of spot
checking or monitoring a patient's SpO2 level, pulse rate and plethysmogram waveform. It
operates with a low power draw, which makes it an attractive choice for use in battery powered
and spot check devices. It can be used for critical care continuous monitoring applications as it
uses BCI® SAC technology (U.S. patent No. 5,558,096). BCI® SAC technology provides low
perfusion and motion tolerance performance.
In addition to averaged SpO2 values, the Digital Micro Power OEM board transfers instantaneous
SpO2 values which may be particularly useful in Sleep Study/Pre-Screening applications. The
Digital Micro Power OEM board is compatible with an assortment of Smiths Medical PM, Inc.
oximeter sensors and patient attachments as well as the Nellcor DS-100A oximeter sensor. The
Smiths Medical PM, Inc. sensors and attachments are available through Smiths Medical PM, Inc.
(See Section 8). The board can be used to monitor neonatal, pediatric, and adult patients. It is
compatible with the existing Micro Power Board (31392B1) allowing existing Micro Power
customers an upwards migration path to increased oximetry performance.
These instructions contain important information for safe use of the product. Read the
entire contents of these Instructions For Use, including Warnings and Cautions, before
using the Digital Micro Power Board. Failure to properly follow warnings, cautions and
instructions could result in death or serious injury to the patient.
2. Theory of Operation
The Oximeter determines %SpO2 and pulse rate by passing two wavelengths of light, one red
(660nm, 2.0mW) and one infrared (905nm, 2.0-2.4mW), through body tissue to a photodetector.
During measurement, the signal strength resulting from each light source depends on the color
and thickness of the body tissue, the sensor placement, the intensity of the light sources, and the
absorption of the arterial and venous blood (including the time varying effects of the pulse) in the
body tissues. The Oximeter processes these signals, separating the time invariant parameters
(tissue thickness, skin color, light intensity, and venous blood) from the time variant parameters
(arterial volume and %SpO2) to identify the pulse rate and calculate oxygen saturation. Oxygen
saturation calculations can be performed because oxygen saturated blood predictably absorbs less
red light than oxygen depleted blood.
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3. Product Specifications1
Data Provided to the Host System
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%SpO2 Range: 0 – 99% with Extended Micro Power Mode

0 – 100% with Digital Micro Power Mode
Resolution: 1%
Standard Adult / Peds: ±2 Arms @ 70-100% SpO2
Accura less than 70% is undefined
cy: Neonate: ±3 Arms @ 70-100% SpO2
less than 70% is undefined
Motion2
Adult / Peds: ±3 Arms @ 70-100% SpO2
Accura
cy:
Low
Adult / Peds: ±3 Arms @ 70-100% SpO2
Perfusi
on3
Neonate: ±3 Arms @ 70-100% SpO2
Accura
cy:
Averaging: 2 (Sleep Mode4), 4, 8, or 16 pulses (default = 8)
The lower the number the more responsive the
display.
Pulse Rate Range: Extended Micro Power Mode:
30 - 254 BPM
Digital Micro Power Mode:
25 - 300 BPM (WW3710, WW3711, V5.11 and Earlier)
20 – 300 BPM (WW3711 V5.12 and Later)
Resolution: 1 BPM
Standard
Accura Arms = ±1
cy:
Motion
Accura No claims made.
cy:
Low
Perfusi
on3 Arms = ±1.5
Accura
cy:
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Averaging: 8 or 16 seconds (default = 8)

The lower the number the more responsive the
display.
Perfusion Index Range: 0.03% to 20.00% 5
Signal Strength Range: 0-8
Bargraph Range: 0 - 14
1
Motion specification valid with BCI® 1300 sensor, all other specifications are valid with
BCI® 3044 sensor. Specifications for additional sensors available upon request.
2
Rubbing and tapping motion – Subject initiated variation maximum amplitude lateral or
vertical of approximately 2.5cm and a maximum frequency of 5Hz. Tested using BCI
1300 sensor.
3
Pulse Amplitude <1% (high sensitivity mode not enabled). Tested using industry
standard simulator.
4
Mode is used for Sleep Studies/Pre-Screening where faster averaging is required.
5
As tested with Industry Standard Simulator.
Plethysmogram Range 0-100

Gain
Automatic (default) or Fixed
Options
Auto Gain Plethysmogram gain normalized automatically.
Gain range: 0 – 99 (Host sets gain, default 0)
Fixed Gain
Plethysmogram gain supplied by Host
Calibration Factory calibrated over range 70% to 100% using
human blood samples to functional
saturation. Test methods are available upon
request. No in-service calibration is required.
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Flags Pulse Beep: Flag set when a valid pulse is

detected.
No Finger in Sensor: Flag set when the board

does not detect a finger in the sensor.
Sensor Unplugged: Flag set when the board does

not detect a sensor connected to it.
Searching for Pulse: Flag set when the board is in

the process of locating a valid pulse.
Searching too long: Flag set after no valid pulse

and now greater than 20 seconds of searching for
a valid pulse.
Lost Pulse: Flag set after at least one valid pulse

and now greater than 20 seconds of searching for
a valid pulse. The flag is also set while in normal
sensitivity mode the perfusion index drops below
0.03% and the 20 second timeout occurs. The
second condition occurs when invalidating heart
rate and SpO2 data due to low levels of perfusion
index.
Additional Flags: Only Small Pulse: This flag is set if the difference
available when the between the max and min of the IR pulsatile
board is in signal is below a threshold level.
“Digital Micro
Power Mode” Artifact: This flag is an indication that pulse rate
data has changed and now is invalid.
Software Revision X.XX format transmitted upon reset/power up or
when requested
Serial Communication
3.3V CMOS voltage levels
Logic Levels
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Environment
Temperature Operating: 0 to 55°C
Storage: -40 to 75°C
Relative Humidity Operating: 15 to 95% (non-condensing)
Storage: 10 to 90% (non-condensing)
Power Requirements
Power Supply Input Voltage +3.3V, electrically isolated
Typical Current Draw 14mA @ 3.3V (average)
Power Supply Load Regulation To be determined.
Power Supply Ripple Voltage When using a switching power supply, operation
may be affected due to high frequency ripple
voltage at the switching frequency. Ripple
and noise levels should be checked to verify
proper operation of the oximeter board.
Recommended Power Supply Bulk
1500uF Low ESR Tantalum or equivalent.
Filtering Capacitance
Dimensions
Width 1.53 inches (39 mm)
Depth 0.8 inches (20 mm)
Height 0.24 inches (6.1 mm)
4. Serial Communications Specifications

The WW3711 Digital Pulse Oximeter board communicates with the Host device through a single
asynchronous serial channel at CMOS voltage levels. Data provided to the Host includes %SpO2,
Pulse Rate, Signal Strength, Bargraph, Plethysmogram, and Status Bits data. Communications
with the board is accomplished with one of two protocols. The first protocol is identical to the
protocol used with the Micro Power Oximeter Board (31392B1). This protocol will be referenced
in this document as the Extended Micro Power Mode. The second protocol is the Digital Micro
Power Mode.
In the Extended Micro Power Mode only two CMOS signals (RESET and SYNC) are used to
transfer requests from the Host device to the board. In the Extended Micro Power Mode data is
sent from the WW3711 board to the Host at a baud rate of 4800 baud, 8 bits, one stop bit, and no
parity.
In the Digital Micro Power Mode the Host can send commands to control the averaging rates,
enable/disable the auto synchronization of the Plethysmogram Waveform, and request the
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Oximeter software revision level. In the Digital Micro Power Mode data is sent from the
WW3711 board to the Host at a baud rate of 19200 baud, 8 bits, one stop bit, and even parity.
4.1 Extended Micro Power Mode Communication Protocol: WW3711 board to the
Host.
Data is sent from the WW3711 board to the Host at a rate of 60 packets per second. Each packet
consists of four data bytes. The first byte in the packet has bit 7 set to logic 1, all other bytes have
bits 7 set to logic 0. This feature is used by the Host to find the first bytes in the data stream.
The structure of the data packet is shown in the following table:
Byte Bit(s) Description

0 0 Pulse beep signal
1…3 Slow data address, bits 0…2
4 Always 0
5 Always 0
6 1 – if bytes 1, 2, 3 are used for the software revision number,
0 – if bytes 1, 2, 3 are used for Oximetry data
7 Always 1 – sync bit, indicating the first byte in the packet (all other bytes in
the packet have bit seven set to zero).
1 0…6 Real time plethysmogram waveform in the range 0 ...100
7 Always 0
2 0…3 Real time Bar Graph, in the range of 0 …14. Zero value of the Bar Graph
indicates no finger in sensor.
4 Always 0
5 Always 0
6 Pulse Rate most significant bit (bit 7).
7 Always 0
3 0…6 Value of these bits depends on the address field in byte 0, see table below
7 Always 0
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The following table indicates the value of bits 0…6 of byte 3 of the data packet depending on the
address field in byte 0: The address field is sequenced with each data packet. Therefore, the data
in this table is sent to the Host at 7.5Hz.
Address Description of bits 0…6 of byte 3

Field
0 SpO2 in the range of 0…99, 127 – invalid SpO2.
1 Bits 0…6 of Pulse Rate (note: bit 7 is located in byte 2). Pulse Rate range
is 30…254 bpm, 255 – invalid Pulse Rate.
2 Signal Strength in the range 0…8
3 Flags:
0 – no flags;
1 – sensor is unplugged;
2 – no finger in sensor or sensor problem;
3 – searching for pulse;
4 – searching too long;
5 – lost pulse
4 Instantaneous SpO2; it is sent with each pulse detected; it equals zero in
between the pulses. Host system can use instantaneous SpO2 to build its
application-specific averaging algorithm.
5 Red system gain index, defined by the servo portion of the software.
6 Infrared system gain index, defined by the servo portion of the software.
Can be used to define “no finger in sensor” condition.
7 Used for production tests only.
If bit 6 of the first byte is logic 1, then the packet is used for the software revision number in the
format x.xx, where x – is an ASCII character.
4.2 Extended Micro Power Mode Host Control Signals to WW3711 Board
• RESET signal. Active – logic 0. This signal is used to reset the WW3711 board and to request
software revision number, because the first twenty communication packets after reset contain
software revision number. RESET signal needs to be kept in logic 0 state for at least 2mS to
be accepted by the WW3711 board.
• SYNC signal. Transition from logic1 to logic 0 requests plethysmogram scale and offset
adjustment. If the board does not receive SYNC signal for 20 seconds, plethysmogram scale
and offset will be adjusted automatically. The duration of SYNC pulse should not be less than
1µS.
4.3 Digital Micro Power Mode Communication Protocol: WW3711 board to the
Host.
Data is sent from the WW3711 board to the Host at a rate of 60 packets per second. Each packet
consists of 11 data bytes. The first byte in the packet has bit 7 set to logic 1, all other bytes have
bits 7 set to logic 0. This feature is used by the Host to find the first bytes in the data stream. In
The structure of the data packet is shown in the following table:
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Byte Bit(s) Description

0 0-3 Signal Strength, range = 0-8
4 1 = Searching too long
5 1 = Sensor unplugged
6 1 = Pulse beep
7 1 (sync. Bit)
1 0-6 Plethysmogram waveform, range = 0-100
7 0 (sync. Bit)
2 0-3 Bar Graph, range = 0-14, 0 = no finger in sensor
4 1 = No finger in sensor or sensor unplugged
5 1 = Searching for pulse
6 1 = Sleep Mode5,6 enabled
7 0 (sync. Bit)
3 0-6 Pulse rate, bits 0-65, range = 25-300, 1024 = invalid
7 0 (sync. Bit)
4 0-6 %SpO2, range = 0-100, 127 = invalid
7 0 (sync. Bit)
5 0-1 00 = 4 beat average %SPO2, 8 beat average Pulse Rate
01 = 8 beat average %SPO2, 8 beat average Pulse Rate
10 = 16 beat average %SPO2, 16 beat average Pulse Rate,
2 beat average %SpO2, 8 beat average Pulse Rate in Sleep Mode6,7
11 = 16 beat average %SPO2, 8 beat average Pulse Rate
2 1 = Artifact
3 1 = Small pulse
4 Spare, not used
5 1 = Lost pulse
6 1 = Auto plethysmograph scaling disabled
7 0 (sync. Bit)
6 0-6 Perfusion index8, bits 0-6, range = 0000-2000
7 0 (sync. Bit)
7 0-4 Perfusion index8, bits 7-11, range = 0000-2000
5 1 = High sensitivity mode enabled
6 Spare, not used
7 0 (sync. Bit)
8 0-2 Pulse rate5, bits 7-9, range = 25-300, 1024 = invalid
3-6 Spare, not used
7 0 (sync. Bit)
9 0-6 Spare, not used
7 0 (sync. Bit)
10 0-6 Checksum9 bits 0-6
7 0 (sync. Bit)
11 0-6 Checksum9 bits 7-13
7 0 (sync. Bit)
5
Pulse rate is a 10 bit value. To calculate pulse rate use the following equation:
(Byte 8 bits 2-0)*128 + (Byte 3 bits 6-0)
6
Sleep Mode is used for Sleep Studies/Pre-Screening where faster averaging is required.
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7
Sleep Mode must be enabled prior to entering the 2 beat %SpO2 average, 8 second Pulse Rate
average.
8
Perfusion index is a 12 bit value. To calculate the perfusion index value use the following
equation: (Byte 7 bits 4-0)*128 + (Byte 6 bits 6-0)
9
The checksum is 14 bits. The checksum is calculated using the following method:
Sum = byte[0] + byte[1]… byte[9]
Checksum = Sum * -1
4.4 Digital Micro Power Mode Host Control Signals to WW3711 Board
When the system is set to run in the Digital Micro Power Mode the Host system can send ASCII
characters to the Digital Micro Power Board to place it into different operating modes. The Host
should wait at least one second after power up before sending any request to the oximeter board.
At start up the Host should place the oximeter into the modes they desire. Failure to perform this
task may lead to the oximeter reporting erroneous operating modes. After entering or exiting
Sleep Mode, the Host shall set the %SpO2 and Pulse Rate averaging mode.
ASCII Character Description

A Sync plethysmogram, forces re-sync (scaling adjustment), loads sync
timer
B 4 beat %SpO2 average, 8 second Pulse Rate average
C 8 beat %SpO2 average, 8 second Pulse Rate average (default)
D 16 beat %SpO2 average, 16 second Pulse Rate average, or
2 beat %SpO2 average, 8 second Pulse Rate average if in Sleep Mode10
E Send revision (Normal mode = ALX.XX, Sleep Mode = ASX.XX )
F 16 beat %SpO2 average, 8 second Pulse Rate average
G Stops auto sync timer functionality
H Starts auto sync timer functionality (auto sync is default)
I Sleep Mode11 on
J Sleep Mode11 off
KNN Fixed plethysmogram gain, NN are ASCII numbers for 0-99
L Clear plethysmogram fixed gain, and setup the automated gain calc
M Toggle between High Sensitivity Mode and Normal Sensitivity Mode12
Notes:
10
Sleep Mode must be turned on prior to entering the 2 beat %SpO2 average, 8 second Pulse Rate
average.
11
Sleep Mode is used for Sleep Studies/Pre-Screening where faster averaging is required.
12
High Sensitivity Mode allows the oximeter to report values under 0.03% pulse amplitude.
Listed claims of accuracy are not valid when the oximeter is in High Sensitivity Mode.
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5. Dimensions/Pin Descriptions
5.1 Dimensions
Mechanical dimensions are shown below. Connectors are shown with pins marked.
WW3711 board can be positioned on the Host board and secured utilizing the three mounting
holes provided on the Digital Micro Power Board. The mounting holes are 66th in diameter. The
mounting holes are designed to be used with 0-80 screws. Example of the board placement is
shown below:
Preferred Host connectors (header type) are TMMH-104-01-L-DV-A for both J1 and J2. Headers
are manufactured by SAMTEC USA (www.samtec.com).
Note: Care should be taken to insure that the 31402B2 board is connected to the Host
Board correctly. If the boards are not connected correctly then the 31402B2 board will not
function properly.
Note: Connector needs to be gold plated to assure low resistance and reliability of contacts.
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Connector J1 can be routed to the board-mounted DB-9 connector. DB-9 connector is used to
connect to SpO2 sensor. Suggested Host board layout fragment is shown below:
5.2 Pin Descriptions

J1 - Oximeter Sensor Connector
J1 Pin BCI Cable Color Code DB9 Pin
1 White 5
2 Black 9
3 Yellow 6
4 Shield 7
5 No connect -
6 Green 1
7 Orange 3
8 Red 2
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J2 - Power and Communication Connector

Pin Pin Name Description
1 No Connect Not used
2 Protocol Select 1 = Extended Micro Power Protocol
0 = Digital Micro Power Protocol
3 GND Ground connection
4 +3.3V Input power pin
5 SYNC/RXD
In the Extended Micro Power Mode a transition
from logic 1 to logic 0 requests
plethysmogram scale and offset adjustment.
Note: if SYNC signal is not received by the
board for 20 seconds, plethysmogram scale
and offset will be adjusted automatically.
In the Digital Micro Power Mode the pin will
act as an asynchronous data pin.
6 /RESET Input Resets the board and if in Extended Micro
Power Mode requests twenty sequential
Software Revision communication packs.
7 GND Ground connection
8 TX Output Data from the Digital Micro Power Board to the
Host System
6. Sample Host Software Subroutine

6.1 Extended Micro Power Mode
Following is an example communication interface routine run by the Host. It receives a byte from
the communication controller and decodes it. This code should not be used in a Host system
without proper testing and validation.
Typedef unsigned char byte;
#define MINGAIN 5 // IR gain less or equal to this number would indicate

// “no finger” condition
byte beep; // non-zero requests audio “beep” signal

byte pleth; // plethysmogram waveform
byte bargrph; // bar graph
byte o2; // averaged SpO2 value
byte o2r; // instantaneous (non-averaged) SpO2 value
byte hr; // rate value
byte slev; // signal level
byte flags; // system flags
char rev[5]; // software revision number
char rgain, igain; // red and infrared system gain indexes
// This routine receives a data byte from asynchronous communication

// controller and decodes it
void decode (byte a)
{
static byte i = 100; // index for the state machine, set
// to “invalid” for now
static byte address; // address field
static byte msrate; // contains most significant rate bit
static byte nftimer = 0; // time out since igain fell out of range
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// catch syncro bit

if ( a & 0x80 ) i = 0;
// byte-by-byte state machine

switch(i)
{
case 0: // revision or normal data ?
if ( a & 0x40 ) i=4; // in case of revision
else
{
// request “beep”
if ( a & 1 && !nftimer ) beep = TRUE;
else beep = FALSE;
// save address field

address = a & 0xe;
// next state – second data byte

i = 1;
}
break;
case 1: // second data byte

if ( !nftimer )
pleth = a;
else
pleth = 0;
// next state – second data byte

i = 2;
break;
case 2: // third data byte

if ( !nftimer )
bargraph = a & 0xf;
else
bargraph = 0;
// save the most significant rate bit

msrate = a & 0x40;
// next state – fourth data byte

i = 3;
break;
case 3: // fourth data byte

// branch on address field
switch ( address )
{
case 0: // SpO2
if ( !nftimer )
o2 = a;
else
o2 = 127;
break;
case 2: // Rate
if ( !nftimer )
{
if ( msrate ) hr = a | 0x80;
else hr = a;
}
else hr = 255;
break;
case 4: // Signal level

if ( !nftimer )
signal = a;
else
signal = 0;
break;
case 6: // Flags
if ( !nftimer )
flags = a;
Rev. 2 2nd, June 2008 31402tec2

Page 20 of 38
else
flags = 2; // no finger in sensor
break;
case 8: // Instantaneous SpO2

if ( !nftimer )
o2r = a;
else
o2r = 0;
break;
case 10: // Red gain

rgain = a;
break;
case 12: // Infrared gain

igain = a;
if ( igain <= MINGAIN )
nftimer = 60; // one second of no finger
// if igain is out of range
break;
default: break;
}
// update no finger timer with 60Hz

if ( nftimer ) nftimer--;
// set index to invalid

i = 100;
break;
case 4: // first byte of software revision number

rev[0] = a; rev[1] = ‘.’;
// next state – second byte of the software revision

i = 5;
break;
case 5: // second byte of revision number

rev[2] + a;
// next state – third byte of the software revision

i = 6;
break;
case 6: // third byte of revision number

rev[3] = a; rev[4] = 0;
// set index to invalid

i = 100;
break;
default: break;
}
}
Rev. 2 2nd, June 2008 31402tec2

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6.2 Digital Micro Power Mode

Following is an example communication interface routine run by the Host. It
receives a byte from the communication controller and decodes it. This code
should not be used in a Host system without proper testing and validation.
// Maximum constants
unsigned char PLETHMAX = 99;
unsigned char SPO2MAX = 100;
unsigned char SPO2MIN = 50;
unsigned char SIGNALSTRENGTHMAX = 0x0f;
unsigned int SPO2PRMAX = 750;
unsigned int SPO2PRMIN = 30;
unsigned int PERFUSIONINDEXMAX = 4000;
// Invalid constants
unsigned char PLETHINVALID = 0x7F;
unsigned char SPO2INVALID = 0x7f;
unsigned char SIGNALSTRINVALID = 0x0f;
unsigned int SPO2PRINVALID = 0x3FF;
unsigned int PERFUSIONINDEXINVALID = 0XFFF;
// local values
unsigned char ParserIndex;
unsigned char PlethValue;
unsigned char SignalStrength;
unsigned char OxBar;
unsigned char OxAveragingSetting;
char RevisionString[10];
unsigned int SpO2Value;
unsigned int PulseRate;
unsigned int PerfusionIndex;
unsigned int CalculatedChecksum;
unsigned int ReceivedChecksum;
unsigned char Artifact;

unsigned char Searching;
unsigned char SearchTooLong;
unsigned char ProbebUnpluged;
unsigned char LostPulse;
unsigned char CheckSensor;
unsigned char SmallPulse;
unsigned char PulseBeep;
unsigned char AutoSynchOff;
unsigned char SleepMode;
unsigned char RevisionReady;
unsigned char PISensitivity;
unsigned char BadChecksum;
void Parser(unsigned char ParseMe);
void Parser(unsigned char ParseMe)

{
// if the synch bit is set, it is the start of a new packet, reset all values
if (ParseMe & 0x80)
{
ParserIndex = 0;
}
switch(ParserIndex)
{
case 0: //bits 0 - 3: Signal Strength (0xF = invalid)
//bit 4: searching too long, bit
//bit 5: Probe Unplugged
//bit 6: pulse beep
//bit 7: 1 (synch bit)
if (ParseMe & 0x80)
{
if (ParseMe == 0x80)
{
RevisionReady = 0x80;
}
Rev. 2 2nd, June 2008 31402tec2

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SignalStrength = (ParseMe & 0x0F);

SearchTooLong = ParseMe & 0x10;
ProbebUnpluged = ParseMe & 0x20;
PulseBeep = ParseMe & 0x40;
CalculatedChecksum = (unsigned int) ParseMe;
ParserIndex++;
}
break;
case 1: //bits 0 - 6: Plethysmogram
if (!((RevisionReady) && ParseMe == 0x00))
{
RevisionReady = 0;
PlethValue = ParseMe;
if (PlethValue > PLETHMAX && PlethValue != PLETHINVALID)
{
PlethValue = PLETHMAX;
}
}
CalculatedChecksum += (unsigned int) ParseMe;
ParserIndex++;
break;
case 2: //bits 0 - 3: Bargraph
//bit 4: no finger in probe
//bit 5: searching for pulse
//bit 6: sleep mode indicator bit
if (RevisionReady)
RevisionString[0] = ParseMe;
else
{
OxBar = ParseMe & 0xF;
CheckSensor = ParseMe & 0x10;
Searching = ParseMe & 0x20;
SleepMode = ParseMe & 0x40;
}
ParserIndex++;
break;
case 3: //bits 0 - 6: Rate bits 0 - 6
//bit 7: 0(synch bit)
if (RevisionReady)
else
PulseRate = (unsigned int)ParseMe & 0x7F;
ParserIndex++;
break;
case 4: //bits 0 - 6: SpO2 bits 0 - 6
//bit 7: 0(synch bit)
if (RevisionReady)
else
{
SpO2Value = ParseMe;
if (SpO2Value >= SPO2INVALID)
SpO2Value = SPO2INVALID;
}
ParserIndex++;
break;
case 5: //bits 0 - 1:
// 00 = 4 beat SpO2 8 sec PR Averaging
//bit 2: artifact
//bit 3: small Pulse
//bit 4: Revision Level Reply
//bit 5: Lost Pulse
//bit 6: disable auto pleth scaling
if (RevisionReady)
{
RevisionString[3] = '.';
Rev. 2 2nd, June 2008 31402tec2

Page 23 of 38
}
else
{
OxAveragingSetting = ParseMe & 0x03;
Artifact = ParseMe & 0x04;
SmallPulse = ParseMe & 0x08;
LostPulse = ParseMe & 0x20;
AutoSynchOff = ParseMe & 0x40;
}
ParserIndex++;
break;
case 6:
//bits 0 - 6: Perfusion Index bits 0 - 6
if (RevisionReady )
{
}
else
PerfusionIndex = (unsigned int)ParseMe;
ParserIndex++;
break;
case 7:
//bits 0 - 4: Perfusion Index bits 7 - 11
//bit 5 1 = PI Sensitivity is ON
if (!(RevisionReady))
{
PISensitivity = ParseMe & 0x20;
PerfusionIndex += (unsigned int)(ParseMe & 0x1F) * 128;
}
ParserIndex++;
break;
case 8:
//bits 0-2: Rate bits 7-9
//bits 3-6: Unused
if (RevisionReady == 0)
{
PulseRate += (unsigned int)(ParseMe & 0x07) * 128;
if (PulseRate >= SPO2PRINVALID)
PulseRate = SPO2PRINVALID;
}
ParserIndex++;
break;
case 9:
//bits 0-6: Spare
ParserIndex++;
break;
case 10:
//bits 0-6 Checksum Bits 0-6
ReceivedChecksum = ParseMe;
ParserIndex++;
break;
case 11:
//bits 0-6 Checksum Bits 7-13
ReceivedChecksum += (unsigned int)ParseMe * 128;
if (CalculatedChecksum + ReceivedChecksum == 16384)
{
BadChecksum = 0;
}
else
{
BadChecksum = 1;
}
ParserIndex = 0;
break;
default: //something went wrong, don't depend on the data
Rev. 2 2nd, June 2008 31402tec2

Page 24 of 38
ParserIndex = 0;
break;
}
}
7. Sensors
Choose the appropriate sensor from the following charts.
Smiths Medical PM, Inc. Sensors
Patient Site Description
Adult Finger 3044: Sensor, Adult (reusable)
> 45 Kg
3444: Sensor, Comfort-Clip (reusable)
Finger or Toe 3043: Sensor, Universal ‘Y’ (reusable)
1300: Sensor, Adult (disposable) 2
Ear 3078: Sensor, Ear (reusable)
Pediatric Finger 3044: Sensor, Adult (reusable) (> 20 kg)
15-45 Kg
3444: Sensor, Comfort-Clip (reusable)
3178: Sensor, Pediatric (5-45 kg)
Finger or Toe 3043: Sensor, Universal ‘Y’ (reusable)
1301: Sensor, Pediatric (disposable) 2
Ear 3078: Sensor, Ear (reusable)
Infant Hand or Foot 3043: Sensor, Universal ‘Y’ (reusable)
3-15 Kg
Toe 3025: Sensor, Wrap, Infant (reusable)
Finger or Toe 1303: Sensor, Infant (disposable) 2
Neonate Hand or Foot 1302: Sensor, Neonate, (disposable) 2
< 3 Kg
Foot 3026: Sensor, Wrap, Neonate (reusable)
All 3311: Extension cable
Nellcor Sensors
Patient Site Description
Adult Finger DS-100A: Sensor, Adult (reusable)
> 40 Kg
All DEC8: Extension cable
8. Checking Pulse Oximeter Performance
Rev. 2 2nd, June 2008 31402tec2

Page 25 of 38
Pulse Oximeters do not require user calibration. To check the function of the device, an optional
Oximeter/ECG Patient Simulator is available as an accessory (Smiths Medical PM, Inc. Cat#
1606). The simulator attaches to the Oximeter in place of the sensor or patient cable. It provides a
known %SpO2 and pulse rate signal to the Oximeter, allowing the Oximeters performance to be
checked. Follow the instructions included with the Oximeter/ECG Patient Simulator.
9. Response Time
9.1 %SpO2 Averaging
The following graph shows the responsiveness of %SpO2 when different averaging options are
used. The %SpO2 decreases at 0.66% per second until 70% is reached then increases at 4% per
sec until 96% is reached. The pulse rate was set to 75bpm.
Response Time as a Function of SpO2 Averaging
100
95
90
85
Simulator
% SpO2
2-8 Averaging
80 4-8 Averaging
8-8 Averaging
16-8 Averaging
75
70
65
60
0 20 40 60 80 100 120 140
Time (seconds)
Rev. 2 2nd, June 2008 31402tec2

Page 26 of 38
9.2 Pulse Rate Averaging

The following graph shows the response of the pulse rate when different averaging options are
used. The pulse rate decreases at 0.66 beats per second. The %SpO2 was set to 96%.
Heart Rate Averaging Responses
90
80
70
Heart Rate (Beats/Sec)
60
Simulator
16-8 Averaging
16-16 Averaging
50
40
30
20
0 50 100 150 200 250
Time (seconds)
10. Demonstration Software

Smiths Medical PM, Inc. provides PC software for demonstration purposes only. The intent is to
allow the OEM customer to quickly become familiar with the operation of the Oximeter board.
This software is NOT to be used in any product for sale. This software is for evaluation
only. Do not connect directly to a patient without proper patient isolation.
11. Ordering Information

For ordering information, please contact Smiths Medical PM, Inc. customer service:
Smiths Medical PM, Inc. Phone ((262) 542-3100

N7W22025 Johnson Drive Toll Free (in USA only):
Waukesha, WI 53186 USA 1-800-558-2345
Fax: (262) 542-0718
E-mail address: info.pm@smiths-medical.com
Rev. 2 2nd, June 2008 31402tec2

Page 27 of 38
Appendix A
Clinical Desaturation Summary

for the
Digital Micro Power Oximeter Board
Rev. 2 2nd, June 2008 31402tec2

Page 28 of 38

31400
Pulse Oximeter Module
(Board 31402B2)
Desaturation Clinical Investigation
(Desat 37)
Final Report – Materials and Methods
Device Description
The Digital Micro Power OEM Oximeter board (Board 31402B2) is a satellite or daughter board capable of spot checking
or monitoring a patient's SpO2 level, pulse rate and plethysmogram waveform. The Digital Micro Power OEM Oximeter
board (Board 31402B2) is not a standalone device and is intended to be integrated into a (Host) medical monitor. It will be
compatible will all existing BCI® sensors and approved for neonatal, pediatric and adult patients. It will be backwards
compatible with the existing Micro Power Oximeter Board (31392B1) allowing existing Micro Power customers an
upwards migration path to increased oximetry performance.
Clinical Investigation Plan Summary
Objectives: The intent of this validation study was to test the accuracy of the oxygen saturation (SpO2) parameter of the
SMPM 31400 Pulse Oximeter Module (Board 31402B2) with various sensors. There were nine test oximeter modules
using eight sensor types in this study. The sensors included in this study were the SMPM 3043, SMPM 3044 (two), 3078
and 3178. Additionally, three Nellcor sensor types were tested DS-100A, OxiBand A/N and D-YS (pediatric).
Investigation Design: This study was a descriptive, cross-sectional investigation of healthy, human subjects comparing
pulse oximetry determined functional oxygen saturation values (SpO2) – test condition – to CO-oximetry based functional
oxygen saturation (SaO2) – reference condition. The study was conducted at varied oxygen concentration to obtain
functional Sa02 levels evenly distributed generally between 70% and 100%. The pass criterion was a root-mean-square
error (ARMS) value of 4 %-SpO2 or less.
Ethics Considerations: The study was reviewed by the Institutional Review Board of the Zablocki VM Medical Center,
known as the Human Studies Subcommittee. The study title is Validation of Pulse Oximeters (VA Project Number: 1445-
05 and HRRC Number: 73-93).
Data Quality Assurance: Data was obtained electronically using the CRAWDADS program and was analyzed using the
CRAWDADS_EXCEL template. Both analysis vehicles have undergone validation for accuracy. Additionally, written
report forms were kept as a back-up to the electronic copies. The data analysis template is password protected. Original
electronic data collection spreadsheets are read only and retained. CO-oximeter data are recorded manually from two
calibrated CO-oximeters (one serving as a verification of the other for suspect readings).
Subject Population: The paid, volunteer subjects were recruited by the VA Medical Center. Subjects were recruited to
include a range of ages between 18 to 40 years and skin pigmentation and both genders. Subject data could be excluded if
there were conditions that made monitoring impossible or nearly impossible such as poor peripheral circulation or certain
cardiac arrhythmias.
The sample size was based on a recommendation of the US Food and Drug Administration that least 200 data pairs
obtained from 10 subjects be the minimum number sampled for each oximeter-sensor pair.
Rev. 2 2nd, June 2008 31402tec2

Page 29 of 38
Treatment and Treatment Allocation: Not applicable: there was no treatment offered in this study.
Investigation Variables: The pulse-oximetry derived oxygen saturation values (SpO2) were compared to the CO-oximeter
based functional oxygen saturations (SaO2). Measurements targeted to be taken between a SaO2 of 70% and 100%.
Concomitant Medications/Treatments: There were no medications or treatments given in this study. Subject
medications were not controlled for in this investigation.
Duration of Follow-up: No follow-up visits were planned or performed. Subjects were advised to contact the Clinical
Investigator if follow-up was needed.
Statistical Analysis: The statistical analysis was performed using the SMPM CRAWDADS_EXCEL template. The pass
criterion was a root-mean-square error (ARMS) value of less than 4%-SpO2.
Analysis of the oxygen saturation parameter values included: difference (test – reference), average difference, root-mean-
square error (ARMS), slope and intercept of the test versus reference values, regression analysis, and a count of the sample
pairs used in the analysis. Regression, difference and bubble plots of the data are provided in this report.
Final Report – Summary

(BCI Sensors Only)
Title of Investigation: Validation of Pulse Oximeters
Device under Test: Smiths Medical PM, Inc. (SMPM) 31400 (Board 31402B2) Pulse Oximeter Module
Smiths Medical PM, Inc. 31400 Pulse Oximeter Module (Board 31402B2) with various sensors. The sensors under test
with the pulse oximeter module included BCI® (SMPM) Models 3043, 3044, 3078 and 3178.
Subjects: Ten paid, adult, volunteer subjects participated in this trial. The subjects were recruited by the Zablocki VA
Medical Center. They varied in age from 20 to 30 (mean 24.6) years. There were two Black or African American and
eight White subjects enrolled. All subjects described themselves ethnically as non-Hispanic or non-Latino. There were six
female and four male subjects in this trial.
Methods: This study was a descriptive, cross-sectional investigation of healthy, human subjects comparing the SMPM
31400 Pulse Oximeter Module determined oxygen saturation (SpO2) values (test conditions) to CO-oximeter determined
functional oxygen saturation (SaO2) values (reference condition) using various pulse oximeter sensors. The study was
conducted at oxygen concentrations that targeted an even distribution over the SaO2 range of 70% to 100%-SaO2. The data
was electronically gathered by the SMPM proprietary CRAWDADS program and analyzed by the CRAWDADS_EXCEL
template. Manual recording of the data was also made. One data pair was not available for analysis due to oximeter cut
out.
Results: The root-mean-square error (ARMS) value for the test condition was within the pass criterion of less than 4%-SpO2
for all tested oximeter-sensor pairs. The results are summarized in Table 1 below:
Conclusions: The Smiths Medical PM, Inc. Smiths Medical M, Inc. 31400 Pulse Oximeter Module (Board 31402B2)
Pulse Oximeter operated within the pass criterion of less than 4%-SpO2 evenly distributed over the range 70% to 100%-
SaO2 for all tested sensors.
Start Date/Stop Date: 22-May-2007/23/May-2007
Rev. 2 2nd, June 2008 31402tec2

Page 30 of 38
Data Analysis: Table 1 (below) shows the summary information for Desat 37 study.
Data Sets
Average Standard Minimum Maximum

ARMS Accuracy
Sensor (Oximeter) Difference Deviation Difference Difference
(%-SpO2) (%-SpO2)
(%-SpO2) (%-SpO2) (%-SpO2) (%-SpO2)
Excluded
Analyzed
Unavailable
3044 (3304)
-0.71 1.66 1.81 -6 5 220 0 0 NA
Control
3044 -0.91 1.64 1.87 -7 6 440 0 0 ±2
3078 2.22 3.03 3.75 -4 12 220 0 0 ±4
3043 1.43 2.23 2.65 -3 7 220 0 0 ±3
3178 0.02 1.52 1.51 -8 7 220 0 0 ±2
Table 1 – This table contains the results for the SMPM 31400 (Board 31402B2) Pulse Oximeter Module Clinical Desaturation Investigation (Desat 37) using the
listed sensors.
Page 31 of 38
31400
(Board 31402B2)
Desaturation Clinical Investigation
(Desat 38)
Device Description
The Digital Micro Power OEM Oximeter board (Board 31402B2) is a satellite or daughter board capable of spot checking
or monitoring a patient's SpO2 level, pulse rate and plethysmogram waveform. The Digital Micro Power OEM Oximeter
board (Board 31402B2) is not a standalone device and is intended to be integrated into a (Host) medical monitor. It will be
compatible will all existing BCI® sensors and approved for neonatal, pediatric and adult patients. It will be backwards
compatible with the existing Micro Power Oximeter Board (31392B1) allowing existing Micro Power customers an
upwards migration path to increased oximetry performance.
SMPM 31400 Pulse Oximeter Module (Board 31402B2) with various sensors. There were nine test oximeter modules
using five sensor types in this study. The sensors included in this study were the SMPM 1300 (two), SMPM 1302 (two),
SMPM 3026 (two) and SMPM 3444 (two) and SMPM 3078 (one).
Investigation Design: This study was a descriptive, cross-sectional investigation of healthy, human subjects comparing
pulse oximetry determined functional oxygen saturation values (SpO2) – test condition – to CO-oximetry based functional
oxygen saturation (SaO2) – reference condition. The study was conducted at varied oxygen concentration to obtain
functional Sa02 levels evenly distributed generally between 70% and 100%. The pass criterion was a root-mean-square
error (ARMS) value of 4 %-SpO2 or less.
Ethics Considerations: The study was reviewed by the Institutional Review Board of the Zablocki VM Medical Center,
known as the Human Studies Subcommittee. The study title is Validation of Pulse Oximeters (VA Project Number: 1445-
05 and HRRC Number: 73-93).
Data Quality Assurance: Data was obtained electronically using the CRAWDADS program and was analyzed using the
CRAWDADS_EXCEL template. Both analysis vehicles have undergone validation for accuracy. Additionally, written
report forms were kept as a back-up to the electronic copies. The data analysis template is password protected. Original
electronic data collection spreadsheets are read only and retained. CO-oximeter data are recorded manually from two
calibrated CO-oximeters (one serving as a verification of the other for suspect readings).
Subject Population: The paid, volunteer subjects were recruited by the VA Medical Center. Subjects were recruited to
include a range of ages between 18 to 40 years and skin pigmentation and both genders. Subject data could be excluded if
there were conditions that made monitoring impossible or nearly impossible such as poor peripheral circulation or certain
cardiac arrhythmias.
Page 32 of 38
Investigation Variables: The pulse-oximetry derived oxygen saturation values (SpO2) were compared to the CO-oximeter
based functional oxygen saturations (SaO2). Measurements targeted to be taken between a SaO2 of 70% and 100%.
Duration of Follow-up: No follow-up visits were planned or performed. Subjects were advised to contact the Clinical
Investigator if follow-up was needed.
Statistical Analysis: The statistical analysis was performed using the SMPM CRAWDADS_EXCEL template. The pass
criterion was a root-mean-square error (ARMS) value of less than 4%-SpO2.
Analysis of the oxygen saturation parameter values included: difference (test – reference), average difference, root-mean-
square error (ARMS), slope and intercept of the test versus reference values, regression analysis, and a count of the sample
pairs used in the analysis. Regression, difference and bubble plots of the data are provided in this report.
Title of Investigation: Validation of Pulse Oximeters
Device under Test: Smiths Medical PM, Inc. (SMPM) 31400 (Board 31402B2) Pulse Oximeter Module
Smiths Medical PM, Inc. 31400 Pulse Oximeter Module (Board 31402B2) with various sensors. The sensors under test
with the pulse oximeter module included BCI® (SMPM) Models 1300, 1302, 3026, 3078 and 3444.
Subjects: Ten paid, adult, volunteer subjects participated in this trial. The subjects were recruited by the Zablocki VA
Medical Center. They varied in age from 20 to 39 (mean 25.9) years. Two Black or African American, seven White
subjects and one subject who did not indicate a race were enrolled. Eight subjects described themselves ethnically as non-
Hispanic or non-Latino and two as Hispanic or Latino. There were five female and five male subjects in this trial.
Methods: This study was a descriptive, cross-sectional investigation of healthy, human subjects comparing the SMPM
31400 Pulse Oximeter Module determined oxygen saturation (SpO2) values (test conditions) to CO-oximeter determined
functional oxygen saturation (SaO2) values (reference condition) using various pulse oximeter sensors. The study was
conducted at oxygen concentrations that targeted an even distribution over the SaO2 range of 70% to 100%-SaO2. The data
were electronically gathered by the SMPM proprietary CRAWDADS program and analyzed by the CRAWDADS_EXCEL
template. Manual recording of the data was also made. Twenty-two data pairs were not available for analysis due to a
subject with a dysmorphic nail that made accurate placement of the oximeter sensor impossible on the left middle finger.
Results: The root-mean-square error (ARMS) value for the test condition was within the pass criterion of less than 4%-SpO2
for all tested oximeter-sensor pairs. The results are summarized in Table 1 below:
Conclusions: The Smiths Medical PM, Inc. Smiths Medical M, Inc. 31400 Pulse Oximeter Module (Board 31402B2)
Pulse Oximeter operated within the pass criterion of less than 4%-SpO2 evenly distributed over the range 70% to 100%-
SaO2 for all tested sensors.
Start Date/Stop Date: 19-June-2007/20-June-2007

Data Sets
Average Standard Minimum Maximum

Sensor ARMS Accuracy
Difference Deviation Difference Difference
(Control Oximeter) (%-SpO2) (%-SpO2)
(%-SpO2) (%-SpO2) (%-SpO2) (%-SpO2)
Excluded
Analyzed
Unavailable
3044
(3304) -1.02 1.59 1.89 -5 6 221 0 0 NA
(Control)
3444 0.26 1.93 1.94 -3 8 442 0 0 ±2
1300 0.34 1.49 1.53 -3 7 420 221 0 ±2
1302 -0.32 1.99 2.01 -5 8 442 0 0 ±2
3026 1.07 2.22 2.46 -3 11 442 0 0 ±2.5
3078 2.26 2.45 3.33 -3 9 221 0 0 ±4
Table 1 – This table contains the results for the SMPM 31400 (Board 31402B2) Pulse Oximeter Module Clinical Desaturation Investigation (Desat 38) using the
listed sensors.
1
Subject 7 had a dysmorphic nail on the left middle finger. No sensor was placed at this site on this subject.
Page 34 of 38
31400
(Board 31402B2)
Motion Clinical Investigation
(Desat 39)
Device Description
The Digital Micro Power OEM Oximeter board (31402B2 board) is a satellite or daughter board capable of spot
checking or monitoring a patient's SpO2 level, pulse rate and plethysmogram waveform. The Digital Micro Power
OEM Oximeter board (31402B2 board) is not a standalone device and is intended to be integrated into a (Host)
medical monitor. It will be compatible will all existing BCI® sensors and approved for neonatal, pediatric and adult
patients. It will be backwards compatible with the existing Micro Power Oximeter Board (31392B1) allowing
existing Micro Power customers an upwards migration path to increased oximetry performance.
Objectives: The intent of this validation study was to test the accuracy of the oxygen saturation (SpO2) parameter of
the SMPM 31400 Pulse Oximeter Module (Board 31402B2) under motion conditions. Additionally, the non-motion
testing using Nellcor™ DS-100A Sensors was made. There were eight test oximeter modules used in this study.
Four modules were used for the motion testing using BCI® (SMPM) 1300 Adult Disposable Sensors, there were two
modules using DS-100A Sensors (one old style – gray connector and one new style – blue connector) for accuracy
testing of the Nellcor™ sensors. Two modules using BCI® (SMPM) 1300 sensors were used as controls.
Additionally, a SMPM 3304 Pulse Oximeter using a BCI® (SMPM) 3044 sensor was used as an additional control.
Investigation Design: This study was a descriptive, cross-sectional investigation of healthy, human subjects
comparing pulse oximetry determined functional oxygen saturation values (SpO2) during controlled tapping and
rubbing motions – test condition – to CO-oximetry based functional oxygen saturation (SaO2) – reference condition.
The study was conducted at varied oxygen concentration to obtain functional Sa02 levels evenly distributed generally
between 70% and 100%. The pass criterion was a root-mean-square error (ARMS) value of 4 %-SpO2 or less.
Ethics Considerations: The study was reviewed by the Institutional Review Board of the Zablocki VM Medical
Center, known as the Human Studies Subcommittee. The study title is Validation of Pulse Oximeters (VA Project
Number: 1445-05 and HRRC Number: 73-93).
Data Quality Assurance: Data were obtained electronically using the CRAWDADS program and were analyzed
using the CRAWDADS_EXCEL template. Both analysis vehicles have undergone validation for accuracy.
Additionally, written report forms were kept as a back-up to the electronic copies. The data analysis template is
password protected. Original electronic data collection spreadsheets are read only and retained. CO-oximeter data
are recorded manually from two calibrated CO-oximeters (one serving as a verification of the other for suspect
readings).
Subject Population: The paid, volunteer subjects were recruited by the VA Medical Center. Subjects were
recruited to include a range of ages between 18 to 40 years and skin pigmentation and both genders. Subject data
could be excluded if there were conditions that made monitoring impossible or nearly impossible such as poor
peripheral circulation or certain cardiac arrhythmias.
Investigation Variables: The pulse-oximetry derived oxygen saturation values (SpO2) under controlled motion
were compared to the CO-oximeter based functional oxygen saturations (SaO2). Measurements targeted to be taken
between a SaO2 of 70% and 100%.
Duration of Follow-up: No follow-up visits were planned or performed. Subjects were advised to contact the
Clinical Investigator if follow-up was needed.
Statistical Analysis: The statistical analysis was performed using the SMPM CRAWDADS_EXCEL template. The
pass criterion was a root-mean-square error (ARMS) value of less than 4%-SpO2.
Analysis of the oxygen saturation parameter values included: difference (test – reference), average difference, root-
mean-square error (ARMS), slope and intercept of the test versus reference values, regression analysis, and a count of
the sample pairs used in the analysis. Regression, difference and bubble plots of the data are provided in this report.
Title of Investigation: Validation of Pulse Oximeters – Motion Protocol
Device Under Test: Smiths Medical PM, Inc. Model 31400 Pulse Oximeter Module (Board 31402B2)
Objectives: The intent of this Clinical Investigation was to determine the oxygen saturation accuracy specifications
for the Model 31400 Pulse Oximeter Module (Board 31402B2) during controlled motion.
Subjects: Ten paid, adult, volunteer subjects participated in this trial. The subjects were recruited by the Zablocki
VA Medical Center. They varied in age from 22 to 34 (mean 27.3) years. Two Black or African American, seven
White subjects and one subject who did not indicate a race were enrolled. Seven subjects described themselves
ethnically as non-Hispanic or non-Latino and three as Hispanic or Latino. There were four female and six male
subjects in this trial.
Methods: This study was a descriptive, cross-sectional investigation of healthy, human subjects comparing four
Model 31400 Pulse Oximeter Modules (Board 31402B2) determined oxygen saturation (SpO2) values during motion
(test condition) to CO-oximeter determined functional oxygen saturation (SaO2) values (reference condition). Two
additional Model 31400 Pulse Oximeter Modules (Board 31402B2) which were not subjected to motion were used
as a control and to determine stable plateaus in the oxygen saturation readings. Two Model 31400 Pulse Oximeter
Modules (Board 31402B2) using Nellcor™ DS-100A sensors also not subjected to motion were (one old style –
gray connector and one new style – blue connector) tested. The study was conducted at oxygen concentrations that
targeted an even distribution over the SaO2 range of 70% to 100%-SaO2. The motion protocol used in this study
consisted of tapping and rubbing motions of randomly varied frequency and amplitude. The maximum frequency
was 300 cycles/minute (5 Hz). The maximum height was generally approximately 2.5 cm. The data were
electronically gathered by the Smiths Medical PM, Inc. proprietary CRAWDADS program and analyzed by the
CRAWDADS_EXCEL template. Manual recording of the data was also made. Subject data associated with a
perfusion index of less than 1% determined by the test devices was not used in the analysis.
Results: (Test Condition – Motion) The root-mean-square error (ARMS) value for the test condition was within the
pass criterion of less than or equal to 4%-SpO2 (2.18%-SpO2). There was a very small positive bias (0.04%-SpO2).
The standard deviation was 2.18%-SpO2 (see Table 1 below).
Conclusions: The Smiths Medical PM, Inc. Model 31400 Pulse Oximeter Modules (Board 31402B1) operated at a
level within the pass criterion of less than or equal to 4%-SpO2 evenly distributed over the range 70% to 100%-SaO2
during motion of controlled amplitude and frequency. The data from the test devices associated with perfusion index
values of less than 1 percent determined by the test devices was not included in the analysis.
Data Gathering Start Date/Stop Date: 08-May-2007/09-May-2007

Data Sets
Oximeter or Module
Average Standard Minimum Maximum Accuracy
ARMS
(Sensor) Difference Deviation Difference Difference (ARMS)
(%-SpO2)
(%-SpO2) (%-SpO2) (%-SpO2) (%-SpO2) (%-SpO2)
Condition
Analyzed
Excluded
Unavailable
31400
(Board 31402B2)
(1300) 0.04 2.18 2.18 -25 10 856 242 0 ±3
Motion
Test
31400
(Board 31402B2)
-0.36 2.02 2.05 -13 6 414 263 0 ±2.5
DS-100A Sensor
Test
31400
(Board 31402B2)
0.36 1.90 1.93 -4 8 414 264 0 NA
(1300)
Non-motion Control
3304
(3044) -1.06 1.44 1.79 -4 3 218 25 0 NA
Control
Table 1 – This table contains the results for the SMPM 31400 (Board 31402B2) Pulse Oximeter Module Motion Clinical Investigation (Desat 39)
2
Sixteen data pairs were unavailable due to monitor cut-outs; eight data pairs were unavailable because a blood sample not drawn due to subject feeling warm (ended early).
3
Twenty-two data pairs unavailable due to inability to place sensor secondary to a dysmorphic nail; four data pairs were unavailable because a blood sample not drawn due to subject
feeling warm (ended early)
4
Twenty-two data pairs unavailable due to D38-1 module not functioning (USB communication failure – no power to board or sensor); four data pairs were unavailable because a
blood sample not drawn due to subject feeling warm (ended early).
5
Two data pairs were unavailable because a blood sample not drawn due to subject feeling warm (ended early)

Technical Description SpO2

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Smiths Medical PM, Inc.

BCI® OEM Technologies

Table of Contents Page

Rev. 2 2nd, June 2008 31402tec2

Warnings, Cautions, & Notes

CAUTION Tells you something that could damage the monitor

NOTE Tells you other important information

Rev. 2 2nd, June 2008 31402tec2

WARNING: Significant levels of dysfunctional hemoglogins, such as carboxyhemoglogin or

Rev. 2 2nd, June 2008 31402tec2

Rev. 2 2nd, June 2008 31402tec2

Rev. 2 2nd, June 2008 31402tec2

Rev. 2 2nd, June 2008 31402tec2

%SpO2 Range: 0 – 99% with Extended Micro Power Mode

Rev. 2 2nd, June 2008 31402tec2

Averaging: 8 or 16 seconds (default = 8)

Plethysmogram Range 0-100

Rev. 2 2nd, June 2008 31402tec2

Flags Pulse Beep: Flag set when a valid pulse is

No Finger in Sensor: Flag set when the board

Sensor Unplugged: Flag set when the board does

Searching for Pulse: Flag set when the board is in

Searching too long: Flag set after no valid pulse

Lost Pulse: Flag set after at least one valid pulse

Rev. 2 2nd, June 2008 31402tec2

4. Serial Communications Specifications

Rev. 2 2nd, June 2008 31402tec2

Byte Bit(s) Description

Rev. 2 2nd, June 2008 31402tec2

Address Description of bits 0…6 of byte 3

Rev. 2 2nd, June 2008 31402tec2

Byte Bit(s) Description

Rev. 2 2nd, June 2008 31402tec2

ASCII Character Description

Rev. 2 2nd, June 2008 31402tec2

Rev. 2 2nd, June 2008 31402tec2

5.2 Pin Descriptions

Rev. 2 2nd, June 2008 31402tec2

J2 - Power and Communication Connector

6. Sample Host Software Subroutine

#define MINGAIN 5 // IR gain less or equal to this number would indicate

byte beep; // non-zero requests audio “beep” signal

// This routine receives a data byte from asynchronous communication

Rev. 2 2nd, June 2008 31402tec2

// catch syncro bit

// byte-by-byte state machine

// save address field

// next state – second data byte

case 1: // second data byte

// next state – second data byte

case 2: // third data byte

// save the most significant rate bit

// next state – fourth data byte

case 3: // fourth data byte

case 4: // Signal level

Rev. 2 2nd, June 2008 31402tec2

case 8: // Instantaneous SpO2

case 10: // Red gain

case 12: // Infrared gain

// update no finger timer with 60Hz

// set index to invalid

case 4: // first byte of software revision number

// next state – second byte of the software revision

case 5: // second byte of revision number