MS/MSX/uSpO2 PreV&V Protocol Checklist/Data Tables

1.1 Implemented Parameters and Features

Base Parameters:
SpO2........................................... ✘
Pulse Rate................................... ✘
Perfusion Index........................... ✘
PVI (optional).............................☐

Base Settings:
Averaging Modes
2-4 seconds.................................
4-6 seconds.................................
8 seconds.................................... ✘
10 seconds..................................
12 seconds..................................
14 seconds..................................
16 seconds..................................

Sensitivity Modes
Normal........................................ ✘
APOD......................................... ✘
Maximum................................... ✘

FastSat Mode
On............................................... ✘
Off.............................................. ✘

SmartTone Mode
On............................................... ✘
Off.............................................. ✘

Alarm Delay Settings – Host feature, not related to Masimo protocol

Yes..............................................
No............................................... ✘
Settings (specify)

Waveforms:
Pleth............................................ ✘
Signal IQ....................................
Resp. filter..................................
 MS/MSX/uSpO2 PreV&V Protocol Checklist/Data Tables

For all section topics below, please indicate with an “OK”, or “Verified” when returning the document to
Masimo. Use Masimo simulator MSCPT.exe to confirm the applicable details of the protocol integration
tables in this document, See R-CSD1133 for simulator interface details and instructions details.
1.2 Activate Host Configurable Features command

1.2.1 Ensure the Activate Host Features Command Sent (this is a Masimo requirement for new integrations)
(Expiration Message Support)?
Yes

Note: This feature is only available on DSP versions V5.1.0.3 and later of MS-2003/2011/2013 boards and DSP versions
V2.1.0.0 and later of MS-2040, MSX-2040, boards and uSpO2 cables. It is required for all new integrations.
1.2.1.1 Is the AHCF (activate host configurable features) command resent whenever a board reset occurs (ref CSD-1186)?
Yes
1.3 Displayed Settings vs. MX Board Settings, state match
1.3.1 Ensure all user interface settings match the actual board state during run-time and power cycles/board resets.
1.3.2 Ensure the host software reads the board settings state to confirm the user interface setting matches.

1.4 Loss of Communication

1.4.1 Ensure a loss of communication with the board protocol produces the following:
1.4.1.1 Dashed or removed screen numeric.
1.4.1.2 Removed waveforms.
1.4.1.3 Audible/visual alert indicating an SpO2 communication error to the end-user.

1.5 Parameter Numerics:

1.5.1 Ensure the display precision of numerics are in accordance with Masimo guidance document R-CSD1132.
1.5.2 Ensure numeric are rounded in accordance with the display precision. Received values must never be
truncated on the display.
1.5.3 Ensure all received numerics are displayed in <=2 seconds.
1.5.4 Ensure the user interface displays the full range of the associated numeric.
1.5.5 Ensure a numeric value of zero is not displayed in the user interface (a numeric zero is an invalid data
indicator and should be represented in the user interface with dashes or an empty field for the parameter numeric).

1.6 Feature Settings:

1.6.1 Ensure Maximum sensitivity is not allowed as a default. The device must use Normal or APOD instead upon
power cycle or reset.
1.6.2 Ensure Averaging time settings are independent of the FastSAT ON/OFF state.
1.6.3 Ensure FastSAT ON/OFF state is independent of the Averaging time setting.

1.7 Sensor Type, Sensor Family, and Sensor Algorithm Modes

1.7.1 Ensure these messages are not used in host logic. These fields are for information only. Optionally, these
messages may be ignored.
MS/MSX/uSpO2 PreV&V Protocol Checklist/Data Tables
 MS/MSX/uSpO2 PreV&V Protocol Checklist/Data Tables

1.8 Pulse-Ox System Exceptions (all exceptions must be handled by the host and displayed to the end-user).
1.8.1 Ensure all display messages are in accordance with Masimo guidance document R-CSD1257.
1.8.2 Ensure the host does not remove parameter values from the screen during any exception event.
1.8.3 Ensure the host does not implement additional logic using Masimo exception events .
1.8.3.1 The only time a parameter value should be removed or dashed from the user interface is when the associated
parameter invalid exception is active (i.e. numeric “0”), or whenever a board/diagnostic failure is active.

1.9 Averaging Modes

2-4 Default Value on Power Up: Verified

4-6 Selectable through User Interface: -
✘8 Correctly configured: -
10 Returns to Default State on Power
12 Up: -
14
16

1.10 Sensitivity Modes

Default Value on Power Up: Masimo Note: MAX Is not allowed as a
✘ Normal default. The host must ensure the default
✘ Maximum state is always set to either Normal or APOD.
✘ APOD
Verified
Selectable through User Interface: Verified
Correctly configured: Verified
Returns to Default State on Power
Up: Verified

1.11 FastSat
Default Value on Power Up: Verified
✘ On
✘ Off
Selectable through User Interface: Verified
Correctly configured: Verified
Returns to Default State on Power
Up: -
1.12 SmartTone Must be independent of averaging
time: Verified
Default Value on Power Up: Verified
✘ On Selectable through User Interface: Verified
✘ Off Correctly configured: Verified
Returns to Default State on Power
Up: -
 MS/MSX/uSpO2 PreV&V Protocol Checklist/Data Tables

1.13 Saturation 1.14 Pulse Rate 1.15 Perfusion Index

Time
Simulate Displayed Simulated Displayed
Simulated Displayed to Time to Time to
d Pulse Pulse Perfusion Perfusion
SpO2% SpO2% Displa Display Display
Rate Rate Index Index
y
0 -- 1 Sec 0 -- 1 Sec 0.000 -- 1 Sec
35.3 35 1 Sec 25 25 1 Sec 0.020 0.02 1 Sec
50.5 50 1 Sec 60 60 1 Sec 0.040 0.04 1 Sec
70.7 70 1 Sec 100 100 1 Sec 0.080 0.08 1 Sec
90 90 1 Sec 150 150 1 Sec 0.160 0.16 1 Sec
100 100 1 Sec 240 240 1 Sec 0.320 0.32 1 Sec
0.640 0.64 1 Sec
NOTE: The device must dash the displayed value
1.280 1.28
whenever a zero is received.
2.560 2.56 1 Sec
5.120 5.12 1 Sec
10.024 10.02 1 Sec
20.000 20.00 1 Sec
1.16 PVI Values –

Simulated Displayed Time to

PVI PVI Display
0
4
12
35
75
100

1.17 Pulse Beeps

Which Masimo protocol feature is used to generate pulse beeps, Signal IQ or Pulse Beep? - Pulse Beep

1.18 Saw Tooth Waveform

Are waveforms accurately drawn on screen, if utilized? - Yes

1.19 Signal IQ Waveform

Is a vertical Signal IQ bar implemented (show images of the screen)? - No

 MS/MSX/uSpO2 PreV&V Protocol Checklist/Data Tables

1.20 Exceptions
 Ensure exceptions never force a parameter numeric to dash or be removed from the screen. The only
time a numeric should be dashed is when the parameter value received from the MS board protocol module is
“0”. “0” is the indicator for an invalid numeric reading and must be the only indicator used by a host to
remove or dash values from the screen.
 Reference R- CSD-1132 for Masimo guidance on device display exception/message mapping.
 Exceptions 3 messages must be implemented in all new integrations. The Exceptions 2 message “Low
Signal IQ” must be handled as well.
 Exceptions 1 and 2 messages are only shown below for legacy integrations.
 Exception handling can be tested using Masimo protocol simulator tool MSCPT.exe provided in the
development kit documentation and tools zip file.

Exception 1 Exception 2 Displayed Message/Numeric State

Check Sensor No Sensor Connected No Sensor Connected
Check Sensor Defective Sensor Defective Sensor
Low Perfusion, Values OFF Low Perfusion, Values OFF Low Perfusion
Low Perfusion, Values ON Low Perfusion, Values ON Low Perfusion
Pulse Search Pulse Search Pulse Search
Check Sensor Interference Detected Interference Detected
Check Sensor Sensor Off Patient Sensor Off Patient
Check Sensor Too Much Ambient Light Too Much Ambient Light
Check Sensor Unrecognized Sensor Unrecognized Sensor
Check Sensor Reserved 0x0100 Reserved
N/A Reserved 0x0200 Reserved
N/A Low Signal IQ, Values OFF Low Signal IQ
N/A Low Signal IQ, Values ON Low Signal IQ
MasimoSET Processing MasimoSET Processing
MasimoSET Processing Active
Active Active
Check Cable
No Cable Connected No Cable Connected
Check Sensor
Check Adhesive Sensor No Adhesive Sensor
No Adhesive Sensor Connected
Check Sensor Connected
Demo Mode Demo Mode Demo Mode
Reserved 0x8000 Reserved
Check Sensor, Sensor Off Patient
Sensor Off Patient
Masimo SET Processing Masimo SET Processing
Masimo SET Processing Active
Active Active
Check Sensor, Pulse Search,
Pulse Search,
Pulse Search, Sensor Off Patient,
Sensor Off Patient,
Masimo SET Processing Masimo SET Processing
Masimo SET Processing Active
Active Active
Pulse Search, Pulse Search,
Pulse Search,
Masimo SET Processing Masimo SET Processing
Masimo SET Processing Active
Active Active
Check Sensor, Low Perfusion,
Low Perfusion,
Low Perfusion, Interference Detected,
Interference Detected,
Masimo SET Processing Masimo SET Processing
Masimo SET Processing Active
Active Active
Check Sensor, Low Perfusion,
Low Perfusion,
Low Perfusion, Too Much Ambient Light
Too Much Ambient Light
Masimo SET Processing Masimo SET Processing
Masimo SET Processing Active
Active Active
MS/MSX/uSpO2 PreV&V Protocol Checklist/Data Tables

Exceptions 3 Displayed Message/Numeric State

No Cable No Cable Connected
Cable Life Expired (Values ON) Cable Expired
Defective Cable/Cable Life Expired (Values OFF) 0x00000012 Defective Cable & Cable Expired
Incompatible Cable Incompatible Cable
Unrecognized Cable Unrecognized Cable
Defective Cable Defective Cable
Cable Life Near Expiration (Values ON) Cable Near Expiration
Reserved (0x0000 0040) Reserved
No Sensor Connected No Sensor Connected
Sensor Life Expired (Values ON) Sensor Expired
Defective Sensor/Sensor Life Expired (Values OFF) 0x 00000900 Defective Sensor & Sensor Expired
Incompatible Sensor Incompatible Sensor
Unrecognized Sensor Unrecognized Sensor
Defective Sensor Defective Sensor
Check Cable and Sensor Fault Check Cable/Sensor Fault
Reserved (0x0000 2000) Reserved
Sensor Life Near Expiration (Values ON) Sensor Near Expiration
No Adhesive Sensor No Adhesive Sensor Connected
Adhesive Sensor Life Expired (Values ON) Adhesive Sensor Expired
Defective Adhesive Sensor/Adhesive Sensor Life Expired (Values OFF) Defective Adhesive Sensor & Adhesive Sensor
0x0009 0000 Expired
Incompatible Adhesive Sensor Incompatible Adhesive Sensor
Unrecognized Adhesive Sensor Unrecognized Adhesive Sensor
Defective Adhesive Sensor Defective Adhesive Sensor
Sensor Initializing Sensor Initializing
Sensor Off Patient Sensor Off Patient
Pulse Search Pulse Search
Interference Detected (Values ON) Interference Detected
Low Perfusion Index (Values ON) Interference Detected
Demo Mode Demo Mode
Adhesive Life Near Expiration (Values ON) Adhesive Sensor Near Expiration
Reserved (0x0800 0000) Reserved
Check Sensor Connection Check Sensor Connection
SpO2 Only Mode (Values ON) SpO2 Only Mode
Reserved (0x4000 0000) Reserved
Reserved (0x8000 0000) Reserved
Initializing & Off Patient Sensor Initializing & Sensor Off Patient
Pulse Search & Off Patient Pulse Search & Sensor Off Patient
Low Perfusion & Interference (Values ON) Low Perfusion Index & Interference Detected
 MS/MSX/uSpO2 PreV&V Protocol Checklist/Data Tables

1.21 Board Failure Codes

Please ensure all values and waveforms are removed during these events in addition to any display messages.
Failures Device message
DSP: Checksum Failure DSP: Checksum
Failure
DSP: Program Memory Test Failure DSP: Checksum
Failure
DSP: Data Memory Test Failure DSP: Data Memory
Test Failure
DSP: Detector ADC Interrupt Test Failure DSP: Detector ADC
Interrupt Test Failure
DSP: MCU Interrupt Failure
DSP: Diag Queue Overrun DSP: Diag Queue
Overrun
DSP: Hardware Status Failure DSP: Hardware Status
Failure
DSP: Raw Queue Overrun DSP: Raw Queue
Overrun
DSP: MCU Watch Dog Failure DSP: Watch Dog
Failure
DSP: Invalid MC State DSP: Invalid MC State
Diagnostic Failure, 0x0001 LED Ground LED Ground
Diagnostic Failure, 0x0002 Reference Voltage Reference Voltage
Diagnostic Failure, 0x0004 Digital Voltage Digital Voltage
Diagnostic Failure, 0x0008 DSP Voltage DSP Voltage
Diagnostic Failure, 0x0010 Positive LED Voltage Analog Voltage
Diagnostic Failure, 0x0020 Red Current Level Not Defined
Diagnostic Failure, 0x0040 IR Current Level Not Defined
Diagnostic Failure, 0x0080 (Legacy MS2K) Digital Ground, (MS2K SB) DSP Core Not Defined
Voltage
Diagnostic Failure, 0x0100 Positive Preamp Voltage Not Defined
Diagnostic Failure, 0x0200 Preamp Not Defined
Diagnostic Failure, 0x0400 Positive Detector Voltage Not Defined
Diagnostic Failure, 0x0800 Negative Detector Voltage Not Defined
Diagnostic Failure, 0x1000 LED Current LED Current
Diagnostic Failure, 0x2000 Analog Ground Analog Ground
Diagnostic Failure, 0x4000 LED Drive Voltage LED Drive Voltage
Diagnostic Failure, 0x8000 Sensor ID Sensor ID

1.22 Sensor Failures

At the least, the Defective Sensor Exception must be handled.
Exception 2 Seq. 13 Description Displayed Message
Defective Sensor 0 No Failure No Failure
Defective Sensor 1 Open LED's Open LEDs
Defective Sensor 2 Shorted LED's Shorted LED's
Defective Sensor 3 Shorted Detector Shorted Detector
Defective Sensor 4 Bad Sensor ID
Offset Bad Sensor ID Offset
Defective Sensor 5 ProCal Failure ProCal Failure
Defective Sensor 6 Memory Failure Memory Failure
 MS/MSX/uSpO2 PreV&V Protocol Checklist/Data Tables

1.23 Sensor Types

Seq. 4 Description Displayed Message
0 No Sensor Note: No messages are OK. These
1 Masimo LNOP Sensor messages can be ignored.
2,3 Reserved
4 Unknown Sensor These must not be used in any host
5 Hi Fi Sensor (also called Trauma or Newborn) logic software routines.
5 Reserved

1.24 Loss of Communications

Ensure the device dashes values and removes waveforms from the screen. An error message should also be displayed
on screen indicating an issue to the end-user. - Verified