Xpod®
Model 3011LP & 3012LP
Specification and Technical Information
®
NONIN Medical, Inc.
13700 1st Avenue North
Plymouth, Minnesota 55441-5443
USA
763-553-9968
800-356-8874 (USA and Canada)
Fax 763-553-7807
E-mail: info@nonin.com
www.nonin.com
®
© 2011 NONIN Medical, Inc.
7602-000-03
Table of Contents
Specifications ................................................................................................................ 1
Inputs/Outputs: Host Cable Conductors ..................................................................... 4
Inputs.................................................................................................................... 4
Outputs ................................................................................................................. 4
Data Format Selection .............................................................................................. 4
Select Data Format by Hardware Resistor ........................................................... 4
Select Data Format by Software Select ................................................................ 5
Patient Algorithm - SmartPointTM .......................................................................... 5
Serial Data Format #1 .......................................................................................... 6
Serial Data Format #2 .......................................................................................... 7
Serial Data Format #7 ........................................................................................ 11
Serial Data Format #8 ........................................................................................ 15
Indications for Use ...................................................................................................... 17
Contraindications ........................................................................................................ 17
Warnings ...................................................................................................................... 17
Cautions ....................................................................................................................... 17
Accessories ................................................................................................................. 19
Equipment Response Time ........................................................................................ 20
Testing Summary ........................................................................................................ 21
SpO2 Accuracy Testing ........................................................................................... 21
Pulse Rate Motion Testing ...................................................................................... 21
Low Perfusion Testing ............................................................................................ 21
Manufacturer’s Declaration ........................................................................................ 22
i
Specifications
Displayed Oxygen Saturation Range (SpO2)
0 to 100%
Displayed Pulse Rate Range
18 to 321 beats per minute (BPM)
Measurement Wavelengths and Output Power*
Red: 660 nanometers @ 0.8 mW max. avg.
Infrared: 910 nanometers @ 1.2 mW max. avg.
®
(using Nonin PureLight sensor)
SpO2 Accuracy (Arms**)
70 to 100%
No Motion
Adults/Pediatrics***
Neonates
± 2 digits
± 3 digits
± 2 digits
± 3 digits
± 3 digits
N/A
N/A
N/A
N/A
N/A
± 2 digits
± 2 digits
± 2 digits
± 3 digits
± 3 digits
N/A
Low Perfusion****
± 2 digits
± 3 digits
± 3 digits
± 2 digits
N/A
N/A
N/A
± 3 digits
Pulse Rate Accuracy
Adults/Pediatrics***
Neonates
± 3 digits
± 3 digits
± 3 digits
± 3 digits
± 3 digits
N/A
N/A
N/A
N/A
N/A
± 3 digits
± 3 digits
± 2 digits
± 3 digits
± 3 digits
N/A
± 5 digits
± 5 digits
± 5 digits
± 3 digits
N/A
N/A
N/A
± 3 digits
REUSABLE:
8000AX Series:
800XJ Series:
8000SX Series:
8000R:
8000Q2:
DISPOSABLE:
6000 Series:
7000 Series:
6500 Series:
Motion
REUSABLE:
8000AX Series:
800XJ Series:
8000SX Series:
No Motion (18 – 300 BPM)
REUSABLE:
8000AX Series:
800XJ Series:
8000SX Series:
8000R:
8000Q2:
DISPOSABLE:
6000 Series:
7000 Series:
6500 Series:
Motion (40 – 240 BPM)
REUSABLE:
8000AX Series:
800XJ Series:
8000SX Series:
Low Perfusion (40 – 240 BPM) ****
1
* This information is especially useful for clinicians performing photodynamic therapy.
** ±1 Arms represents approximately 68% of measurements.
*** Includes infant patients.
**** Does not apply to those sensors listed as N/A under the neonate column, 8000R and 8000Q2.
Notes:
Reusable Group:
8000AX Finger Clip Sensors: 8000AA-1, 8000AA-3, 8000AP-1, 8000AP-3
800XJ Flex Sensors: 8000J-1, 8000J-3, 8008J, 8001J
8000SX Soft Sensors: 8000SS, 8000SM, 8000SL
Disposable Group:
®
Flexi-Form III (7000 Series) Sensors: 7000A, 7000P, 7000I, 7000N
6000C Series Sensors: 6000CA, 6000CP, 6000CI, 6000CN
Durafoam Disposable Sensors: 6500MA, 6500SA
_______________________________________________________________________________________
Temperature
Operating:
Storage/Transportation:
-05 to +50 °C for Xpod, 0 to +40 °C for sensor
-40 to +70 °C
Humidity
Operating:
Storage/Transportation:
10% to 90% non-condensing
10% to 95% non-condensing
Patient Isolation
Type BF
Leakage Current
Not Applicable
Dimensions
Cable Length:
1 meter ±10% or per customer request (2 meter
maximum)
No larger than 1.1 cubic inches in volume +10%
Housing:
Weight
No more than 75 grams
Power Draw (typical)
Typical
35mW or less with 3.3V input
Power Draw by Voltage Input:
Input Voltage
Power mW
Input Voltage
Power mW
1.0
1.2
1.4
1.6
1.8
2.0
2.2
2.4
2.6
2.8
3.0
3.2
3.3
50
46
41
39
37
36
36
35
34
34
33
33
34
3.4
3.6
3.8
4.0
4.2
4.4
4.6
4.8
5.0
5.2
5.4
5.5
34
35
36
37
39
40
41
43
45
46
47
47
Inrush Power
Shall not exceed an average of 275 mW within a
sliding 5 mS window for any voltage input from 1.0
to 5.5 VDC.
Voltage Input
1.0 to 5.5 VDC, w/100 mV max. ripple
2
Data I/O Signals
0 to +3.7 VDC +/-5%
When connecting serial data directly to an MCU operating from
3.3V or when 3.3V is required, simply down convert 3.7V to 3.3V
per suggested diagram:
Patient Isolation
Meets IEC 60601-1 Dielectric withstand
Degree of protection: Type BF-Applied Part
Leakage Current
Not applicable
Dimensions (approximate)
53 mm (2.1 in.) x 20 mm (0.8 in.) x 15 mm (0.6 in.)
Weight
No greater than 75 g (2.7 oz.) including cable and
Hirose connector
Fluid Spill Resistance
IP33
Ruggedness
Shock
Ruggedness (Vibration)
IEC 60068-2-27
Sinusoidal – IEC 60068-2-6
Random – IEC 60068-2-64
®
Sensors
Designed to use Nonin-branded PureLight
sensors only (see Accessories)
Shielding
An RF shield is included (placed over the analog
components)
Regulatory Status/Information
Contact Nonin regulatory@nonin.com
ROHS
2002/95/EC
3
Inputs/Outputs: Host Cable Conductors
Inputs
Red Wire =
Black Wire =
Yellow Wire =
Power Input (1.0 to 5.5 VDC)
Circuit Ground/Cable Shield
Option 1 – Select data format using resistor in host device per the Data Format Selection.
Option 2 – Select data format using software command per the Data Format Selection.
Outputs
Green Wire =
Blue Wire =
Orange Wire =
Serial Output:
9600 Baud, 8 data bits, One Start bit (Start bit =0), One Stop bit (Stop bit = 1), No Parity.
Output Level: TTL (0 to 3.8 VDC)
Host Input Impedence must greater or equal to 4kΩ.
PPG Output: Digital Pulse Indicator
See Technical Note T-0604 for more information.
NC (reserved for future use)
Note: Xpod is not isolated from input voltage.
Data Format Selection
The default data format for model 3011 is data format 1.
If you ordered the model 3011 and can not use the default DF1, the data format can be changed by using the
hardware select resistor or software select data format options.
The default data format for model 3012 is data format 2.
If you ordered the model 3012 and can not use the default DF2, the data format can be changed by using
the hardware select resistor or software select data format options.
For data formats 7 and 8, the host product must select the data format using the hardware or software data
format select.
Select Data Format by Hardware Resistor
Placing a resistor between Serial Input (yellow wire) and ground at the host connector end of cable can be
used to select the data format. The table below lists the resistor values used per Data Format.
Output Format
Data Format 1*
Data Format 2
Data Format 7
Data Format 8
Data Rate
3 Bytes/once per
second
5 Bytes/75 times per
second
5 Bytes/75 times per
second
4 Bytes/once per
second
Resistor Value (Ohms)
Less than or equal to
626
8.2K +/- 5%
4.3K +/- 5%
22K +/- 5%
*Data format 1 is retained for legacy purposes. If once per second data is desired, please use Data Format 8.
If the resistance is equal or greater to 297K and the software select option is not used, the default data
format will be selected.
4
Select Data Format by Software Select
If the host system does not use a resistor to select the data format, the host can select the Xpod data format
by transmitting a 3-byte serial command within 1 second from power on of the Xpod. To select the data
format, the host must send the Xpod the command as described below:
Byte #1: $53 (ASCII value for letter capital “S”…for “Soft Select”)
Byte #2: The Data Format (Hex value 01 for DF1, 02 for DF2, 07 for DF7, 08 for DF8)
Byte #3: Checksum (Hex value) = Byte#1 + Byte#2
The Xpod must receive the user command within 1 second after power is applied to the Xpod. Commands
after the first second from power on will not be processed.
Data format select by serial configuration from host to XPOD:
9600 Baud, 8 data bits, One Start bit (Start bit =0), One Stop bit (Stop bit = 1), No Parity.
Key Points when using the software select feature:
1. The data format selected by the software command will be lost when power to the Xpod is removed.
2. When using the software select feature, make sure the host device sends the command within one
second after applying power to the Xpod.
3. If the host receives the wrong data format, remove power from the Xpod. Then apply power and send the
desired software command within one second.
Patient Algorithm - SmartPointTM
Data formats 2, 7, and 8 provide a SmartPoint indicator. The SmartPoint Algorithm qualifies the data for
recording purposes and eliminates the guesswork of determining when the patient measurement is qualified
for recording purposes. When the SmartPoint Algorithm indicates the reading is high quality, the SPA bit will
be set in data formats 2, 7, and 8.
5
Serial Data Format #1
This data format provides continuous data transmission of a 3 byte data packet sent once per second. The
data packet includes real-time data including: SpO2 and Pulse Rate formatted for display, and status of the
measurement.
Packet Description
Three bytes of data are transmitted 1 once per second.
Byte 1 - Status
BIT7
BIT6
BIT5
BIT4
BIT3
BIT2
BIT1
BIT0
1
SNSD
OOT
LPRF
MPRF
ARTF
HR8
HR7
*Note: Bit 7 is always set
Byte 2 - Heart Rate
BIT7
BIT6
BIT5
BIT4
BIT3
BIT2
BIT1
BIT0
0
HR6
HR5
HR4
HR3
HR2
HR1
HR0
*Note: Bit 7 is always clear
Byte 3 - SpO2
BIT7
BIT6
BIT5
BIT4
BIT3
BIT2
BIT1
BIT0
0
SP6
SP5
SP4
SP3
SP2
SP1
SP0
*Note: Bit 7 is always clear
The following are all active high:
SNSD:
Sensor Disconnect
Sensor is not connected to oximeter or sensor is inoperable.
OOT:
Out Of Track
An absence of consecutive good pulse signals.
LPRF:
Low Perfusion
Amplitude representation of low/no signal quality.
MPRF:
Marginal Perfusion
Amplitude representation of low/marginal signal quality.
ARTF:
Artifact
Indicated artifact condition on each pulse.
HR8 – HR0:
Heart Rate
Standard 4-beat average values without display holds.
SP6 – SP0:
SpO2
Standard 4-beat average values without display holds.
These SpO2 and HR values are formatted for recording purposes and are updated every 1/3 of second.
When the sensor is removed from the site, these values will be formatted with the missing data value. The
following output options are available in standard mode:
HR:
4-beat Pulse Rate Average
SpO2:
4-beat SpO2 Average
When SpO2 and HR values cannot be computed, the system will send a missing data indicator. For missing
data, the HR equals 511 and the SpO2 equals 127. The missing data could be result of these conditions:
1. Sensor is positioned improperly.
2. Sensor was removed prior to a reading.
3. Signal at the sensor site is not discernable. Warm the site or choose a different site.
6
Serial Data Format #2
This data format provides continuous data transmission of a 5 byte data packet sent 75 times per second.
The data packet includes real-time data including: 8-bit waveform value, six different output options for the
SpO2 value, four different averaging options for the Pulse Rate values, and options formatted for both
recording and display purposes, as well as status information for the measurement.
Packet Description
A frame consists of 5 bytes; a packet consists of 25 frames. Three packets (75 frames) are transmitted each
second.
Packet
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
Frame
Byte 1
Byte 2
Byte 3
Byte 4
Byte 5
01
01
01
01
01
01
01
01
01
01
01
01
01
01
01
01
01
01
01
01
01
01
01
01
01
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
PLETH
PLETH
PLETH
PLETH
PLETH
PLETH
PLETH
PLETH
PLETH
PLETH
PLETH
PLETH
PLETH
PLETH
PLETH
PLETH
PLETH
PLETH
PLETH
PLETH
PLETH
PLETH
PLETH
PLETH
PLETH
HR MSB
HR LSB
SpO2
SREV
reserved
reserved
reserved
STAT2
SpO2-D
SpO2 Fast
SpO2 B-B
reserved
reserved
E-HR MSB
E-HR LSB
E-SpO2
E-SpO2-D
reserved
reserved
HR-D MSB
HR-D LSB
E-HR-D MSB
E-HR-D LSB
reserved
reserved
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
Notes:
Byte number 1 in each frame is set to a value of 1.
Reserved bytes are undefined (range of 0 to 255).
7
Byte 1 – START BYTE:
Always set to a 01 value.
Byte 2 – STATUS BYTE
This byte provides status information at a rate of 1/75 of a second.
Range: 128 to 255
Byte 2 - Status
BIT7
1
BIT6
BIT5
SNSD
ARTF
BIT4
OOT
BIT3
BIT2
BIT1
BIT0
SNSF
YPRF
RPRF
GPRF
SYNC
*Note: Bit 7 is always set.
The following are all active high:
SNSD:
Sensor
Disconnect
Sensor is not connected to oximeter or sensor is inoperable.
ARTF:
Artifact – short
term
Indicates artifact condition of each pulse (occurs only during pulse).
OOT:
Out Of Track
An absence of consecutive good pulse signals.
SNSA:
Sensor Alarm
Device is providing unusable data for analysis ( set when the finger is
removed or sensor is disconnected).
RPRF:
*Red Perfusion
Amplitude representation of low/poor signal quality (occurs only
during pulse).
YPRF:
*Yellow Perfusion
Amplitude representation of low/marginal signal quality (occurs only
during pulse).
GPRF:
*Green Perfusion
Amplitude representation of high signal quality (occurs only during
pulse).
SYNC:
Frame Sync
1 on Frame 1 (0 on frames 2 through 25).
* The oximeter reports each pulse by setting/clearing the RPRF and GPRF bits for a period of 12 frames (160 ms). The
table below describes the condition and state of the pulse perfusion bits.
RPRF Bit 2 of
Status Byte
GPRF Bit 1 of
Status Byte
Green – high pulse signal
0
1
Yellow – low/marginal pulse signal
1
1
Red – low/no pulse signal
1
0
Condition
8
Byte 3 – PLETH BYTE
This byte consists of an 8 bit plethysmographic waveform (pulse waveform). The pulse oximeter infra-red
signal is filtered and then compressed into an 8 bit value. The compression provides good detail for low to
medium pulse signals. For an uncompressed waveform with better resolution, refer to Data Format 7.
Range: 0 to 255
Byte 4 – FLAT BYTE
This byte is used for SpO2, Pulse Rate, and information that can be processed at a rate of 1/3 of a second.
Range: 00 to 127
SREV:
Oximeter Firmware Revision Level
STAT2:
Status Byte 2 (occurs 1 of 25) - description given below
Byte 4 – STAT 2
BIT7
BIT6
BIT5
BIT4
BIT3
BIT2
BIT1
BIT0
0
R
SPA
R
R
R
R
R
*Note: Bit 7 is always set.
The following are all active high:
SPA:
R:
High Quality SmartPoint Measurement
Reserved (range - 0 or 1), for future use
Standard Mode - Formatted for Recording Purposes:
These values are formatted for recording purposes and are updated every 1/3 of second. When the finger is
removed from the device these values will be formatted with the missing data value. The following output
options are available in standard mode:
HR:
E-HR:
SpO2:
E-SpO2:
SpO2 Fast:
SpO2 B-B:
4-beat Pulse Rate Average
8-beat Pulse Rate Extended Average
4-beat SpO2 Average
8-beat SpO2 Extended Average
4-beat Average optimized for fast responding
Beat to Beat value – No Average
When SpO2 and HR cannot be computed, the system will send a missing data indicator. For missing data,
the HR equals 511 and the SpO2 equals 127.
9
Display Mode - Formatted for Display Purposes:
These values are formatted for display purposes and are updated every 1.5 seconds. When the sensor is
removed from the site, the last SpO2 and Pulse Rate reading will be reported for 10 seconds before changing
to the missing data value. During this 10 second period the sensor alarm bit (SNSA) is set, indicating that the
sensor has been removed. This feature is useful for spot-check measurements. The following output options
are available in Display Mode:
HR-D:
E-HR-D:
SpO2-D:
E-SpO2-D:
4-beat Pulse Rate Average
8-beat Pulse Rate Extended Average
4-beat SpO2 Average
8-beat SpO2 Extended Average
When SpO2 and HR cannot be computed, the system will send a missing data indicator. For missing data,
the HR equals 511 and the SpO2 equals 127. The missing data could be result of these conditions:
1. Sensor is positioned improperly.
2. Sensor was removed prior to a reading.
Signal at the sensor site is not discernable. Warm the site or choose a different site.
HR Format:
HR MSB
HR LSB
7
6
5
4
3
2
1
0
0
R
R
R
R
R
HR8
HR7
7
6
5
4
3
2
1
0
0
HR6
HR5
HR4
HR3
HR2
HR1
HR0
7
6
5
4
3
2
1
0
0
SP6
SP5
SP4
SP3
SP2
SP1
SP0
SpO2 Format:
SpO2
R = Reserved (range 0 or 1)
Byte 5 – CHK
This byte is used for the checksum of bytes 1 through 4.
Range: 00 to 255
CHK: Checksum = (Byte 1) + (Byte 2) + (Byte 3) + (Byte 4) modulo 256
10
Serial Data Format #7
This data format provides the same information as Data Format 2, except that the waveform value provides
the full resolution of 16 bits instead of 8 bits. This data format must be selected by hardware resistor select or
software select.
Packet Description
A frame consists of 5 bytes; a packet consists of 25 frames. Three packets (75 frames) are transmitted each
second.
Packet
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
Frame
Byte 1
Byte 2
Byte 3
Byte 4
Byte 5
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
STATUS
PLETH MSB
PLETH MSB
PLETH MSB
PLETH MSB
PLETH MSB
PLETH MSB
PLETH MSB
PLETH MSB
PLETH MSB
PLETH MSB
PLETH MSB
PLETH MSB
PLETH MSB
PLETH MSB
PLETH MSB
PLETH MSB
PLETH MSB
PLETH MSB
PLETH MSB
PLETH MSB
PLETH MSB
PLETH MSB
PLETH MSB
PLETH MSB
PLETH MSB
PLETH LSB
PLETH LSB
PLETH LSB
PLETH LSB
PLETH LSB
PLETH LSB
PLETH LSB
PLETH LSB
PLETH LSB
PLETH LSB
PLETH LSB
PLETH LSB
PLETH LSB
PLETH LSB
PLETH LSB
PLETH LSB
PLETH LSB
PLETH LSB
PLETH LSB
PLETH LSB
PLETH LSB
PLETH LSB
PLETH LSB
PLETH LSB
PLETH LSB
HR MSB
HR LSB
SpO2
SREV
reserved
reserved
reserved
STAT2
SpO2-D
SpO2 Fast
SpO2 B-B
reserved
reserved
E-HR MSB
E-HR LSB
E-SpO2
E-SpO2-D
reserved
reserved
HR-D MSB
HR-D LSB
E-HR-D MSB
E-HR-D LSB
reserved
reserved
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
CHK
Notes:
Byte number 1 in each frame is greater than 127.
Reserved bytes are undefined (range of 0 to 255).
11
Byte 1 – STATUS BYTE
This byte provides status information at a rate of 1/75 of a second.
Range: 128 to 255
Byte 1 - Status
BIT7
BIT6
BIT5
BIT4
BIT3
BIT2
BIT1
BIT0
1
SNSD
ARTF
OOT
SNSF
YPRF
RPRF
GPRF
SYNC
*Note: Bit 7 is always set.
The following are all active high:
SNSD:
Sensor
Disconnect
Sensor is not connected to oximeter or sensor is inoperable.
ARTF:
Artifact
Indicates artifact condition of each pulse (occurs only during pulse).
OOT:
Out Of Track
An absence of consecutive good pulse signals.
SNSA:
Sensor Alarm
Device is providing unusable data for analysis (set when the finger is
removed or sensor is disconnected).
RPRF:
*Red Perfusion
Amplitude representation of low/no pulse signal (occurs only during
pulse).
YPRF:
*Yellow Perfusion
Amplitude representation of low/marginal signal quality (occurs only
during pulse).
GPRF:
*Green Perfusion
Amplitude representation of high signal quality (occurs only during
pulse).
SYNC:
Frame Sync
= 1 to Frame 1 (=0 on frames 2 through 25).
* The oximeter reports each pulse by setting/clearing the RPRF and GPRF bits for a period of 12 frames (160 ms). The
table below describes the condition and state of the pulse perfusion bits.
RPRF Bit 2 of
Status Byte
GPRF Bit 1 of
Status Byte
Green – high pulse signal
0
1
Yellow – low/marginal pulse signal
1
1
Red – low/no pulse signal
1
0
Condition
12
Byte 2 & 3 – PLETH BYTE
These two bytes consist of a 16 bit plethysmographic waveform (pulse waveform).
Range: 0 to 65535 (MSB:LSB )
Byte 2 = MSB Pulse Waveform
Byte 3 = LSB Pulse Waveform
Pulse waveform value = (Byte 2 decimal value * 256) + Byte 3 decimal value
Byte 4 – FLOAT BYTE
This byte is used for SpO2, Pulse Rate, and information that can be processed at a rate of 1/3 of a second.
Range: 00 to 127
SREV:
STAT2:
Oximeter Firmware Revision Level
Status Byte 2 (occurs 1 of 25) - description given below
Byte 4 – STAT 2
BIT7
BIT6
BIT5
BIT4
BIT3
BIT2
BIT1
BIT0
0
R
SPA
R
R
R
R
R
The following are all active high:
SPA:
R:
High quality SmartPoint Measurement
Reserved (range - 0 or 1), for future use
Standard Mode - Formatted for Recording Purposes:
These values are formatted for recording purposes and are updated every 1/3 of second. When the sensor is
removed from the site, these values will be formatted with the missing data value. The following output
options are available in standard mode:
HR:
E-HR:
SpO2:
E- SpO2:
SpO2 Fast:
SpO2 B-B:
4-beat Pulse Rate Average
8-beat Pulse Rate Extended Average
4-beat SpO2 Average
8-beat SpO2 Extended Average
4-beat Average optimized for fast responding
Beat to Beat value – No Average
When SpO2 and HR cannot be computed, the system will send a missing data indicator. For missing data,
the HR equals 511 and the SpO2 equals 127. The missing data could be result of these conditions:
1. Sensor is positioned improperly.
2. Sensor was removed prior to a reading.
3. Signal at the sensor site is not discernable. Warm the site or choose a different site.
13
Display Mode - Formatted for Display Purposes:
These values are formatted for display purposes and are updated every 1.5 seconds. When the sensor is
removed from the site, the last SpO2 and Pulse Rate reading will be reported for 10 seconds before changing
to the missing data value. During this 10 second period the sensor alarm bit (SNSA) is set, indicating that the
sensor has been removed. This feature is useful for spot-check measurements. The following output options
are available in Display Mode:
HR-D:
E-HR-D:
SpO2-D:
E- SpO2-D:
4-beat Pulse Rate Average
8-beat Pulse Rate Extended Average
4-beat SpO2 Average
8-beat SpO2 Extended Average
When SpO2 and HR cannot be computed, the system will send a missing data indicator. For missing data,
the HR equals 511 and the SpO2 equals 127.
HR Format:
HR MSB
HR LSB
7
6
5
4
3
2
1
0
0
R
R
R
R
R
HR8
HR7
7
6
5
4
3
2
1
0
0
HR6
HR5
HR4
HR3
HR2
HR1
HR0
7
6
5
4
3
2
1
0
0
SP6
SP5
SP4
SP3
SP2
SP1
SP0
SpO2 Format:
SpO2
R:
Reserved (range- 0 or 1)
Byte 5 – CHK
This byte is used for the checksum of bytes 1 through 4.
Range: 00 to 255
CHK:
14
Checksum = (Byte 1) + (Byte 2) + (Byte 3) + (Byte 4) modulo 256
Serial Data Format #8
This data format provides continuous data transmission of a 4 byte data packet sent once per second. The
data packet includes real-time data including: SpO2 and Pulse Rate formatted for display and status of the
measurement. This data format must be selected by the hardware resistor select or software select feature.
Packet Description
Three bytes of data are transmitted once per second.
Byte 1 - Status
BIT7
BIT6
BIT5
BIT4
BIT3
BIT2
BIT1
BIT0
1
SNSD
OOT
LPRF
MPRF
ARTF
HR8
HR7
*Note: Bit 7 is always set
Byte 2 - Heart Rate (HR-D)
BIT7
BIT6
BIT5
BIT4
BIT3
BIT2
BIT1
BIT0
0
HR6
HR5
HR4
HR3
HR2
HR1
HR0
*Note: Bit 7 is always clear
Byte 3 - SpO2-D
BIT7
BIT6
BIT5
BIT4
BIT3
BIT2
BIT1
BIT0
0
SP6
SP5
SP4
SP3
SP2
SP1
SP0
*Note: Bit 7 is always clear
Byte 4 – Status2
BIT7
BIT6
BIT5
BIT4
BIT3
BIT2
BIT1
BIT0
0
R
SPA
R
SNSA
R
R
R
*Note: Bit 7 is always clear
The following are all active high:
SNSD:
Sensor Disconnect
Sensor is not connected to oximeter or sensor is inoperable.
ARTF:
Artifact
Indicated artifact condition on each pulse.
OOT:
Out Of Track
An absence of consecutive good pulse signals.
LPRF:
Low Perfusion
Amplitude representation of low/no signal quality.
MPRF:
Marginal Perfusion
Amplitude representation of low/marginal signal quality.
SNSA:
Sensor Alarm
Device is providing unusable data for analysis or sensor is
disconnected.
SPA:
SmartPoint
Algorithm
High quality SmartPoint measurement.
HR8 – HR0:
Heart Rate (HR-D)
4-beat Pulse Rate average formatted for display.
SP6 – SP0:
SpO2 (SpO2-D)
4-beat SpO2 average formatted for display.
R
Reserved
(range – 0 or 1)
Reserved for future use.
15
The SpO2 and Pulse Rate values are formatted for display purposes and are updated every 1.5 seconds.
When the sensor is removed from the site, the last SpO2 and Pulse Rate reading will be reported for 10
seconds before changing to the missing data value. During this 10 second period the sensor alarm bit
(SNSA) is set, indicating that the sensor has been removed. This feature is useful for spot-check
measurements. The following output options are available in Display Mode:
HR-D:
4-beat Pulse Rate Average
SpO2-D:
4-beat SpO2 Average
When SpO2 and HR cannot be computed, the system will send a missing data indicator. For missing data,
the HR equals 511 and the SpO2 equals 127. The missing data could be result of these conditions:
1. Sensor is positioned improperly.
2. Sensor was removed prior to a reading.
3. Signal at the sensor site is not discernable. Warm the site or choose a different site.
16
Indications for Use
The Xpod is intended to provide medical device manufacturers with a small, low-power oximeter that can be
easily attached to a host device externally. The Xpod measures functional oxygen saturation of arterial
hemoglobin (%SpO2) and pulse rate (BPM) for adult, pediatric, infant and neonatal patients. When integrated
with a medical device manufacturer’s host system, the Xpod may be used in any environment where pulse
oximetry measurements are made.
Contraindications
•
Do not use this device in an MR environment.
•
Explosive Hazard: Do not use this device in an explosive atmosphere or in the presence of flammable
anesthetics or gases
•
This module does not meet defibrillation-proof requirement per IEC 60601-1: 1988/A1:1995, clause 17.h.
Warnings
•
Use only with Nonin-branded PureLight® pulse oximeter sensors. These sensors are manufactured to meet the
accuracy specifications for Nonin pulse oximeters. Using other manufacturers’ sensors can result in inaccurate
pulse oximeter performance.
•
Loss of monitoring can result if any objects hinder the pulse measurement. Ensure that no blood flow restrictors
(e.g., blood pressure cuff) hinder pulse measurements.
•
As with all medical equipment, carefully route cables and connections to reduce the possibility of entanglement
or strangulation.
•
Operation of this module below the minimum amplitude of 0.3% modulation may cause inaccurate results.
•
The use of accessories, sensors, and cables other than those specified by Nonin may result in increased
emission and/or decreased immunity of this device.
•
Do not use a damaged sensor.
Cautions
•
The accuracy of the SpO2 measurement may be affected if the total sensor cable length (including extension
cables) is greater than 3 meters (9.8 feet).
•
Follow local, state, or national governing ordinances and recycling instructions regarding disposal or recycling of
the device and device components.
•
In compliance with the European Directive on Waste Electrical and Electronic Equipment (WEEE) 2002/96/EC,
do not dispose of this product as unsorted municipal waste. This device contains WEEE materials; please
contact your distributor regarding take-back or recycling of the device.
•
This pulse oximeter module is designed to determine the percentage of arterial oxygen saturation of functional
hemoglobin. Factors that may degrade pulse oximeter performance or affect the accuracy of the measurement
include the following:
•
excessive ambient light
•
excessive motion
•
electrosurgical interference
•
blood flow restrictors (arterial catheters, blood pressure cuffs, infusion lines, etc.)
•
moisture in the sensor
•
improperly applied sensor
•
incorrect sensor type
•
poor pulse quality
•
venous pulsations
•
anemia or low hemoglobin concentrations
•
cardiogreen or other intravascular dyes
•
carboxyhemoglobin
•
methemoglobin
17
Cautions
•
•
•
dysfunctional hemoglobin
artificial nails or fingernail polish
a sensor not at heart level
•
This device has motion tolerant software that minimizes the likelihood of motion artifact being misinterpreted as
good pulse quality. In some circumstances, however, this device may still interpret motion as good pulse quality.
This covers all available outputs (i.e. SpO2, HR, PLETH, PPG).
•
Inspect the sensor application site at least every 6 to 8 hours to ensure correct sensor alignment and skin
integrity. Patient sensitivity may vary due to medical status or skin condition. Discontinue use of adhesive tape
strips if the patient exhibits an allergic reaction to the adhesive material.
•
This equipment complies with IEC 60601-1-2:2004 for electromagnetic compatibility for medical electrical
equipment and/or systems. This standard is designed to provide reasonable protection against harmful
interference in a typical medical installation. However, because of the proliferation of radio-frequency
transmitting equipment and other sources of electrical noise in healthcare and other environments, it is possible
that high levels of such interference due to close proximity or strength of a source might disrupt the performance
of this device. Medical electrical equipment needs special precautions regarding EMC, and all equipment must
be installed and put into service according to the EMC information specified in this manual.
•
Portable and mobile RF communications equipment may affect medical electrical equipment.
•
Oximeter readings may be affected by the use of an electrosurgical unit (ESU)
•
The oximeter sensor may not work on cold extremities due to reduced circulation. Warm or rub the finger to
increase circulation, or reposition the sensor.
•
A functional tester cannot be used to assess the accuracy of a pulse oximeter or sensor.
For more information about required safety and regulatory requirements for pulse oximeters, refer to
ISO 9919: 2005 and IEC 60601-1: 1988/A1:1995. Additional safety information can be found in the labeling
provided with each Nonin sensor.
18
Accessories
The following Nonin accessories may be used with the Xpod module. See the respective sensor instructions
for detailed information regarding specified sensor use (patient population, body/tissue, and application).
Model Number
8000AA-1
8000AA-3
8000AP-1
8000AP-3
8000J-1
8000J-3
8001J
8008J
8000Q2
8000R
8000SS
8000SM
8000SL
7000A
7000P
7000I
7000N
6000CA
6000CP
6000CI
6000CN
6500SA
6500MA
UNI-RA-0
UNI EXT-X
Description
Adult Articulated Internal Spring Finger Clip, 1 m (3 ft) cable
Adult Articulated Internal Spring Finger Clip, 3 m (9.8 ft) cable
Pediatric External Spring Finger Clip, 1 m (3 ft) cable
Pediatric External Spring Finger Clip, 3 m (9.8 ft) cable
Adult Flex, 1 m (3 ft) cable
Adult Flex, 3 m (9.8 ft) cable
Neonatal Flex, 1 m (3 ft) cable
Infant Flex, 1 m (3 ft) cable
Ear Clip, 1 m (3 ft) cable
Reflectance, 1 m (3 ft) cable
Sensor, Reusable, Soft, Small, 1 m (3 ft) cable
Sensor, Reusable, Soft, Medium, 1 m (3 ft) cable
Sensor, Reusable, Soft, Large, 1 m (3 ft) cable
Flexi-Form® II Adult, 1 m (3 ft) cable, 10-pack
Flexi-Form® II Pediatric, 1 m (3 ft) cable, 10-pack
Flexi-Form® II Infant, 1 m (3 ft) cable, 10-pack
Flexi-Form® II Adult, 1 m (3 ft) cable, 10-pack
Sensor, Disposable, Adult, 45 cm (17.5 in) cable
Sensor, Disposable, Pediatric, 45 cm (17.5 in) cable
Sensor, Disposable, Infant, 90 cm (35.5 in) cable
Sensor, Disposable, Neonate, 90 cm (35.5 in) cable
Sensor, Durafoam Disposable, Standard, 1 m (3 ft) cable
Sensor, Durafoam Disposable, Small, 1 m (3 ft) cable
7.5” 90-degree Patient Cable
Patient Extension Cable (select 1, 3, 6, or 9 meters)
19
Equipment Response Time
SpO2 Values
Standard/Fast Averaged SpO2
Extended Averaged SpO2
Average
Latency
4 beat average
2 beats
8 beat average
2 beats
Average
Latency
4 beat average
2 beats
8 beat average
2 beats
Pulse Rate Values
Standard/Fast Averaged Pulse
Rate
Extended Averaged Pulse Rate
Example – SpO2 Exponential Averaging
SpO2 decreases 0.75% per second (7.5% over 10 seconds)
Pulse Rate – 75 BPM
Specific to this example:
•
The response of the 4-beat average is 1.5 seconds.
•
The response of the 8-beat average is 3 seconds.
20
Testing Summary
SpO2 accuracy, motion and low perfusion testing was conducted by Nonin Medical, Incorporated as
described below.
SpO2 Accuracy Testing
SpO2 accuracy testing is conducted during induced hypoxia studies on healthy, non-smoking, light-to-darkskinned subjects during motion and no-motion conditions in an independent research laboratory. The
measured arterial hemoglobin saturation value (SpO2) of the sensors is compared to arterial hemoglobin
oxygen (SaO2) value, determined from blood samples with a laboratory co-oximeter. The accuracy of the
sensors in comparison to the co-oximeter samples measured over the SpO2 range of 70 – 100%. Accuracy
data is calculated using the root-mean-squared (Arms value) for all subjects, per ISO 9919:2005, Standard
Specification for Pulse Oximeters for Accuracy.
Pulse Rate Motion Testing
This test measures pulse rate accuracy with motion artifact simulation introduced by a pulse oximeter tester.
This test determines whether the oximeter meets the criteria of ISO 9919:2005 for pulse rate during
simulated movement, tremor, and spike motions.
Low Perfusion Testing
This test uses an SpO2 Simulator to provide a simulated pulse rate, with adjustable amplitude settings at
various SpO2 levels. The module must maintain accuracy in accordance with ISO 9919:2005 for pulse rate
and SpO2 at the lowest obtainable pulse amplitude (0.3% modulation).
21
Manufacturer’s Declaration
See the following tables for specific information regarding this module’s compliance to IEC 60601-1-2:2007.
Table 1: Electromagnetic Emissions
Emissions Test
Compliance
Electromagnetic Environment—Guidance
This module is intended for use in the electromagnetic environment specified below.
The customer and/or user of this device should ensure that it is used in such an environment.
RF Emissions
CISPR 11
RF Emissions
CISPR 11
Harmonic
Emissions
IEC 61000-3-2
Voltage
Fluctuations/
Flicker Emissions
IEC 61000-3-3
Group 1
This module uses RF energy only for its internal
function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby
electronic equipment.
Class B
N/A
This module is suitable for use in all establishments,
including domestic and those directly connected to the
public low-voltage power supply network that supplies
buildings used for domestic purposes.
N/A
Table 2: Electromagnetic Immunity
Immunity Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic
Environment—Guidance
This module is intended for use in the electromagnetic environment specified below.
The customer and/or user of this device should ensure that it is used in such an environment.
Electrostatic
±6 kV
Floors should be wood, concrete, or ceramic
Discharge
±6 kV contact
contact
tile. If floors are covered with synthetic material,
(ESD)
±8 kV air
the relative humidity should be at least 30%.
±8 kV air
IEC 61000-4-2
Electrical Fast
Mains power quality should be that of a typical
Transient/Burst
N/A
N/A
commercial or hospital environment.
IEC 61000-4-4
Surge
Mains power quality should be that of a typical
N/A
N/A
commercial or hospital environment.
IEC 61000-4-5
Voltage dips,
short
Mains power quality should be that of a typical
interruptions,
commercial or hospital environment. If the user
and voltage
of the module requires continued operation
N/A
N/A
variations on
during power mains interruptions, it is
power supply
recommended that the device be powered from
input lines
an uninterruptible power supply or battery pack.
IEC 61000-4-11
Power
Frequency
Power frequency magnetic fields should be at
(50/60 Hz)
3 A/m
3 A/m
levels characteristic of a typical location in a
Magnetic Field
typical commercial or hospital environment.
IEC 61000-4-8
Note: UT is the AC mains voltage before application of the test level.
22
Table 3: Guidance and Manufacturer’s Declaration—Electromagnetic Immunity
Immunity Test
IEC 60601 Test
Level
Compliance
Level
Electromagnetic
Environment—Guidance
This module is intended for use in the electromagnetic environment specified below.
The customer and/or user of this module should ensure that it is used in such an environment.
Portable and mobile RF communications equipment should be used no closer to any part of the module, including
cables, than the recommended separation distance calculated from the equation applicable to the frequency of the
transmitter.
Recommended Separation Distance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3V
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m
d = 1.17 P
d = 1.17 P
80 MHz to 800 MHz
d = 2.33 P
800 MHz to 2.5 GHz
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as
a,
determined by an electromagnetic site survey
should be less than the compliance level in each
b
frequency range.
Interference may occur in the vicinity of equipment
marked with the following symbol:
Notes:
•
At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
•
These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects, and people.
a)
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio,
AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the module.
b)
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m.
23
Table 4: Recommended Separation Distances
The following table describes the recommended separation distances between portable and mobile RF
communications equipment and this module.
This module is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. Customers or users of this module can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communication equipment (transmitters) and the module
as recommended below, according to maximum output power of the communications equipment.
Separation Distance According to Frequency of Transmitter
Rated Maximum
Output Power of
Transmitter
W
0.01
0.1
1
10
100
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
d = 1.17 P
d = 1.17 P
d = 2.33 P
0.12
0.37
1.2
3.7
12
0.12
0.37
1.2
3.7
12
0.23
0.74
2.3
7.4
23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
Notes:
•
At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
•
These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects, and people.
24
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