Welch Allyn LC101 User Manual

LC101 CO2 Module

OEM Implementation Manual

LC101 CO

Module OEM Implementation Man ual

is a registered tr ademark, and Pryon™ is a trademark of Welch Allyn, Inc. Welch Allyn, Inc. is protected under various patents and patents pending. Welch Allyn OEM Technologies is a division of Welch Allyn, Inc.

Disc laimers: Welch Allyn OEM Technologies cautions the reader of this manual:

• This manual may be wholly or partially subject to change without notice.

• All rights are reserved. No one is permitted to reproduce or duplicate, in any form, the whole or part of this manual without permission from Welch Allyn OEM Technologies.

For inf ormation concerning this document, contact:

elch Allyn OEM Technologies 8500 SW Creekside Place Beaverton, OR 97008-7107 U.S.A (503) 530-7900 • Fax: (503) 526-4901

PN 000.91161 Rev. 1, September, 2002

age 2

Conﬁ dential

elch Allyn OEM T echnologies

LC101 CO

Module OEM Implementation Man ual

able of Contents

Section 1

Functional Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Terminology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Mainstream vs. Sidestream . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Measuring Principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Measurement Calculation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Measurement Compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Hardware Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

LC101 Main Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Sidestream Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Section 2

LC101 Module Interface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

LC101 Main Board. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

LC101 Module Interface Connector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Watertrap Switch Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Watertrap Receiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Watertrap Receiver Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Exhaust Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Section 3

LC101 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Zero Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Zero Calibration Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Two-Point User Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Two-Point User Calibration Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

elch Allyn OEM T echnologies

onﬁ dential

age 3

LC101 CO

Module OEM Implementation Man ual

Section 4

Host/Module Communications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Communication Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

System EEPROM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Packet Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Host Commands . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Mode Commands . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Simple Commands . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Configuration Commands. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Calibration Commands . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Module Responses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Status Responses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Mode Command Responses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Simple Command Responses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Configuration Command Responses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Calibration Command Responses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Software Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Packets. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Faults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Module Resets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

System Behaviors - Dynamic Communications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Section 5

Pneumatic Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Normal Flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Pneumatic Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

Total Inlet Occlusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

Partial Inlet Occlusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

Total Exhaust Occlusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Partial Exhaust Occlusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Barometric Out Of Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Unexpected Reverse Flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Unexpected Forward Flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Internal Disconnects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Watertrap Receptacle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Sensor Inlet/Outlet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Flow Control Circuitry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Pump Inlet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Pump Exhaust . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Pump Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Low Flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

High Flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

No Flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Section 6

Regulatory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

IEC 601-1-2 (EN 60601-1-2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

Welch Allyn OEM Technologies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

OEM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

age 4

Conﬁ dential

elch Allyn OEM T echnologies

LC101 CO

Electromagnetic Interference. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Electromagnetic Susceptibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Compliance Testing Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

ISO 9918 and EN 864 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Module OEM Implementation Man ual

Appendix A

Software Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

O2/N2O/Desflurane Compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

Correction For O2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

Correction For N2O & O2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

Correction For Desflurane . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Summary of O2, N2O, and Desflurane Compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Percent CO2 Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Zero Calibration Sequence Example. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Two-Point User Calibration Sequence Example . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Example of Verification Using Dry Gas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

CRC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

CCITT/CRC Code Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

Software Upgrade . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

Appendix B

EEPROM Memory Map . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

System EEPROM Map Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Appendix C

Error Messages & Recovery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

Advisories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

LC101 Advisories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

Pneumatic System Advisories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

Calibration Advisories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Soft Faults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Calibration Faults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Sensor Faults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

System Faults. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

Appendix D Welch Allyn OEM Technologies

Part Numbers and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

Module Configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

Accessories Available From Welch Allyn OEM Technologies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

Appendix E

Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

LC101 Main Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Assembly Drawings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

CO2 Absorber Material Safety Data Sheet (MSDS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

elch Allyn OEM T echnologies

onﬁ dential

age 5

LC101 CO

Module OEM Implementation Man ual

Appendix F

CO2 Developer’s Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83

Disclaimer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83

Software Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84

Initial Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85

Menu Options Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86

CO2 Evaluation Platform . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89

Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

age 6

Conﬁ dential

elch Allyn OEM T echnologies

LC101 CO

Module OEM Implementation Man ual

Section 1

Functional Description

Intr oduction

The LC101 Module is designed to control and acquire data from an inter nal Welch Allyn OEM Technologies CO

concentr ation in the patient’s expired respiratory gas can be obtained. The sidestream

system includes an internal sidestream CO

The LC101 Module calculates CO CO

aveform to the host system via a serial communications interface.

bench. Utilizing a pump to aspirate the patient sample to the CO

bench, electronics and pneumatic components .

measurements and respir atory rate and outputs this data with

bench, the

Intended Use

The LC101 Module is intended f or use as a subsystem within a medical instrument or device. The Module measures levels of CO

Module has been designed to be used on both intubated and non-intubated patients. The Module and its accessories should always be used as described in the host system’s operator’s manual and only for the purpose(s) intended. Areas of intended use include:

• Hospital Intensive Care Units (ICU)

• Hospital Emergency Department/EMS (ED/EMS)

• Surgical Operating Rooms (Anesthesia)

• Hospital Post Anesthesia Care Units (PACU)

• Outpatient Surgical Units

contin uously or intermittently in the sidestream mode. The

• Skilled Nursing Facilities / Subacute Care

•Transport (Air, Ground and Sea)

• Home Care / Traditional Health Care

The most common user will be a nurse or skilled healthcare professional (such as an EMT, paramedic, respiratory therapist, clinical engineer, etc.).

elch Allyn OEM T echnologies

onﬁ dential

age 7

LC101 CO

Module OEM Implementation Manual

Terminology

Capnography is the noninvasive measurement and graphic display of airway CO2 concentration as a function of time. The resulting waveform is called a capnogram. The evaluation of the capnogram is useful in the assessment of the adequacy of carbon dioxide exchange in the lungs, integrity of the patient’s airway, cardiopulmonary function and ventilator function.

(mmHg)

Capnogram Components

Time

Monitoring of CO2 concentration at the end of expiration (point D) is referred to as End-Tidal CO2 (ETCO2) monitoring.

Mainstream vs. Sidestream

The patient’s expired gas may be sampled either directly off the patient airway external to the LC101 Module or aspirated from the patient through a cannula into the Module. The method used is dependent on the patient’s airway status.

Mainstream capnography is typically used on intubated or tracheostomy patients and requires the use of an external mainstream sensor. Intubation is the process of inserting a tube into the patient’s trachea to deliver gases to the lungs.

Sidestream capnography is used on patients who are intubated or non-intubated. The patient’s expired gas is aspirated from the airway and transported to the LC101 Module through a sample line. The sidestream sample chamber and sensor are embedded within the LC101 Module. Signal acquisition and measurement calculation are performed by the LC101 Module.

Measuring Principle

CO2 measurement is based on the Infra-Red (IR) absorption characteristics of CO2 molecules. The CO present in the sample gas. CO2 gas has a unique absorption band which is related to a CO2 molecule’s composition and mass. CO2 gas concentration is measured by detecting absorption in this band. Due to the nature of the measurement technique employed, user calibration is necessary with this system.

sensor uses non-dispersive IR spectroscopy to measure the number of CO2 molecules

Page 8 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Section 1 - Functional Description

The basic components of the CO2 sensor (C-Cap bench) include

• IR source

• Dual element IR detector

• optical ﬁlter

• non-volatile memory

The IR source emits energy that is directed toward a dual element thermopile IR detector. The dual element design uses two opposing thermopiles connected in series. As the ambient temperature changes, the two elements change in similar fashion resulting in an output near zero. Only one element is exposed to energy from the IR source, resulting in a voltage change due to only that energy. The detector generates a voltage based on the amount of energy it receives. In the IR path between the IR source and the detector is an

optical ﬁlter which allows

only a speciﬁc IR wavelength to pass and the gas sample within the sensor chamber.

Dual Element Thermopile

detector output

element 1

element 2

narrowband IR pass filter

energy from IR source

foil cover

CO2 Measurement Method

A temperature sensor is attached to the detector housing for temperature compensation beyond the thermopile’s designed compensation, including temperature changes in the system sensitivity. The detector generates a voltage in the mV range and an Op-amp on the circuit board ampliﬁes the signal.

The non-volatile memory is an EEPROM containing calibration and manufacturing data speciﬁc to the CO

sensor.

Measurement Calculation

Measurements provided to the host system by the LC101 Module include ETCO2, Inspiratory

(InsCO2) and respiratory rate (RR). These three measurements are collectively referred to

as breath data. A proprietary breath algorithm is used to calculate the breath data.

Breath Algorithm

Welch Allyn OEM Technologies’s breath algorithm incorporates an initial learning period which, based on certain assumptions of CO

for threshold determinations. A sliding window is used to detect a stable maximum, or ETCO

waveform morphology, establishes CO2 reference points

value, and a baseline, or InsCO2 value. Thresholds are updated in real time with each breath. A signal averaging technique is used to calculate the RR based on this set of measurements.

By incorporating these adaptive and signal averaging techniques, the breath algorithm effectively reports accurate CO

measurements while maintaining a high level of noise immunity.

Welch Allyn OEM Technologies Conﬁdential Page 9

LC101 CO2 Module OEM Implementation Manual

Measurement Compensation

IR absorption in the CO2 wavelength band may be affected by a number of factors that alter the

measurement. The LC101 Module automatically compensates for some of these factors

while others may be disabled by the host system.

These factors include

•water vapor

• pressure broadening

• gas mixing

•oxygen, nitrous oxide and desﬂurane or O2/N2O/desﬂurane

• Body Temperature, ambient Pressure and Saturated with water vapor or BTPS

Water Vapor

Water vapor compensation accounts for the effect that water vapor has on the IR absorption characteristics of CO adjusted mathematically to compensate for this effect.

molecules. During normal sidestream operation, CO2 measurements are

The host may choose to disable this compensation when performing dry gas measurements in which the gas does not contain water vapor. Dry gas procedures may include steady state measurements and calibration procedures. Steady state measurements are performed only when background CO of a steady state measurement is measuring the CO

, or CO2 present in the immediate environment, is measured. An example

content inside an incubator. Calibration

procedures use calibrated gas which is free of water vapor, or dry, as well.

The water vapor compensation is ON by default and may be enabled or disabled via a host system command.

Pressure Broadening

Pressure broadening compensation accounts for the effect that barometric pressure has on CO2 molecule distribution and is used in both measurement and autorun modes.

The pressure broadening compensation is ON by default and cannot be disabled by the host system.

Gas Mixing

A small amount of gas “mixing” occurs as the CO2 sample travels through the tubing to the sample chamber. Gas mixing compensation accounts for the effect that low level gas mixing has

on the baseline, or InsCO2 measurement in both measurement and autorun modes. The gas mixing, or baseline, compensation is ON by default and can be disabled by the host system.

Page 10 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

O2/N2O/desﬂurane

O2/N2O/desﬂurane compensations account for the effects that these gases have on the IR absorption characteristics of CO description of this effect and a recommendation for enabling these compensations.

The O2/N2O/desﬂurane compensations are OFF by default and may be enabled or disabled via a host system command.

BTPS

Often the clinician’s intent is to determine the CO2 levels within the patient’s lungs where gas exchange is taking place. BTPS compensation corrects for the environmental differences between the measurement site (i.e. the bench) and “deep lung” CO2.

The BTPS compensation is ON by default and may be enabled or disabled via a host system command.

molecules. Refer to Appendix A Software Procedures for a

Section 1 - Functional Description

Hardware Components

LC101 Main Board

The LC101 Main Board provides the interface to the host system, manages power requirements, calculates measurements, and regulates pump ﬂow.

The functional components of the Main Board include

• 68HC11 microprocessor with external memory

• reset circuit

•primary power supplies

• analog to digital (A/D) converter

• digital to analog (D/A) converter

• source hybrid

• pressure transducers

68HC11 Microprocessor

The microprocessor controls feedback to the pump and to the temperature and pressure transducer. The microprocessor also provides the communication interface to the host system and interfaces to the external A/D and D/A converters and sensor EEPROM memory. An internal multiplexed A/D converter is used for digital conversion and for monitoring some of the power supplies for fault determinations.

All address decoding is performed by a microprocessor. The software code is stored in FLASH memory and is supplemented by an external static RAM chip. The boot mode of the microprocessor is used to install new software into the FLASH device.

Welch Allyn OEM Technologies Conﬁdential Page 11

LC101 CO2 Module OEM Implementation Manual

Reset Circuit

The ﬁrst section of a 556 timer is connected to a serial receive data line such that the microprocessor is forced into reset if the data line is held in a break condition for greater than 10 msec. A second timer section is used to determine if the break condition is maintained for more than 500 msec.

Holding the receive data line in a break condition for a period of time greater than 10 msec and less than 500 msec is referred to as a reset.

A hard reset occurs when the break condition is held longer than 500 msec. This condition forces the microprocessor to enter the boot mode after the break is released.

Power ON, reset and low voltage lockouts are performed by a reset controller. Undervoltage lockout is set to approximately 4.5 V. On power up, the microprocessor is held in reset for about 100 msec after the supply rises above 4.5 V.

Primary Power Supplies

All primary power supplies run off a single voltage power source and are converted on the Main Board to various levels. The power source is derived from the (+5 V or +5.75 to +14.5 Vdc) Vin power supplied by the host system.

A/D Converter

The 8 channel 12 bit serial A/D converter converts the following analog signals into a binary data stream for the microprocessor: analog waveform from the optical bench, temperature of optical bench, barometric pressure and pneumatic ﬂow rate.

D/A Converter

The 12 bit serial interface D/A converter provides bench source current selection and bench detector bias circuit control.

Source Hybrid

The optical bench requires that the IR source be current-regulated. The current-sensing circuitry is located on a ceramic hybrid module, or source hybrid. A regulator is used that adjusts the output voltage to maintain a constant current.

Pressure Transducers

The pressure circuitry monitors pressure via transducers in order to compensate for the effect of pressure variation on the CO

measurement. The transducers include

• an absolute pressure transducer which initially provides an ambient pressure measurement and then continuously monitors internal bench pressures during pump operation.

•a differential pressure transducer which is used for pump ﬂow regulation.

Due to the use of a single absolute pressure transducer, the ambient pressure measurement is only updated at power on and watertrap replacement.

Page 12 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Section 1 - Functional Description

Sidestream Components

The functional components necessary for sidestream operation include

• pump

•watertrap and watertrap receiver assembly

• inlet and exhaust tubing

•CO2 sample line

• cannula

The ﬂow control circuitry regulates ﬂow by using a ﬁxed oriﬁce ﬂow sensor that provides feedback to a circuit that controls power to the pump. A differential pressure transducer measures the pressure drop across a restrictor and this is used as feedback to adjust the pump speed. The pump power supply steps down the raw voltage applied to the board to a level appropriate for maintaining the desired pump ﬂow rate.

The pump connector provides the electrical connection for the pump to the Main Board.

The watertrap receiver assembly connector provides the electrical connection for the watertrap switch to the Main Board.

Pump

The electrically driven miniature oil-free diaphragm pump is mounted on the Main Board. The pump draws the sample through the sample line to the sample chamber by creating a vacuum. Fault states such as exhaust and watertrap occlusions are recognized by the ﬂow control circuitry. Refer to Section 5, Pneumatic Operation, for additional information on pump function.

Watertrap and Watertrap Receiver Assembly

NOTE The watertrap, watertrap receiver and receiver switch are not included with the LC101

Module and each may be ordered separately from Welch Allyn OEM Technologies or supplied by the OEM.

The watertrap is a user-supplied cartridge that removes excess moisture in the sample line before the sample is delivered to the sample chamber. The watertrap includes a built-in shutoff pellet which is designed to fully occlude once the ﬁlter is saturated.

The functional components of the watertrap assembly include the watertrap receiver and receiver switch.

The watertrap receiver is a receptacle for the watertrap and can be molded by the OEM into the main housing of the host monitor (or purchased from Welch Allyn OEM Technologies as an accessory). The external end of the watertrap is connected to the sample line.

The watertrap receiver switch provides a signal that is used for detection of a properly inserted watertrap into the watertrap receiver before the pump begins operation. This eliminates the possibility of the user bypassing the watertrap.

Welch Allyn OEM Technologies Conﬁdential Page 13

LC101 CO2 Module OEM Implementation Manual

Inlet and Exhaust Tubing

The internal inlet tubing provides the means to transport the gas sample from the watertrap receiver to the sidestream bench. The inlet tubing includes the tubing, connectors and a secondary shutoff pellet. Attachment of the inlet tubing to the watertrap receiver is via a Luer® connector. A secondary shutoff pellet is attached in line with the inlet tubing to provide additional backup.

The exhaust tubing provides the means to expel the exhaust gas. A 5 µm screen, or ﬁlter, is positioned in line with the exhaust tubing to mufﬂe, or reduce the pump noise.

CO2 Sample Line and Cannula

The CO2 sample line, or sample line, is used to transport the gas sample from the patient to the watertrap assembly.

NOTE The sample line is not included with the LC101 Module and may be ordered separately

from Welch Allyn OEM Technologies or other suppliers.

For a non-intubated patient, the sample line connects to a cannula that is positioned on the patient. A variety of cannulas are available to accommodate patient requirements. Nasal, oral/ nasal and divided cannulas which deliver oxygen and sample CO

simultaneously may be used.

NOTE Cannulas are not included with the LC101 Modules and may be ordered separately

from Welch Allyn OEM Technologies or other suppliers.

For an intubated patient, the sample line connects to the patient’s breathing circuit.

Sample connections for both intubated and non-intubated patients are shown below.

Watertrap

Sample line

Watertrap

Sample line

To cannula

Elbow connector to breathing apparatus

Typical Connection to Non-Intubated Patient

Typical Connection to Intubated Patient

Page 14 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Section 2

LC101 Module Interface

Power Requirements

Description Typical

Input voltage range 5 V regulated, or +5.75 to +14.50 Vdc

Ripple 100 mV peak-to-peak

Typical non-measurement mode power 570 mW at 8 Vdc

Typical operating power 1.3 W at 8 Vdc

Typical occluded power 1.5 W at 8 Vdc

LC101 Main Board

Description Speciﬁcation

Dimensions 3.15 in. L x 3.90 in. W x 1.00 in. H

(80.3 mm × 99.3 mm × 25mm)

Orientation No limitations

Weight < 1 lb (454 gm)

Welch Allyn OEM Technologies Conﬁdential Page 15

LC101 CO2 Module OEM Implementation Manual

LC101 Module Interface Connector

The LC101 Module interface connector is a 4-pin connector (Molex P/N 22-11-2042). The host may use a 4-pin polarized housing (Molex P/N 22-01-3047 with Molex 2759 series terminals) or equivalent.

Pin Signal Signal Description

Vin

input power

2 gnd ground

3 TXD data from Main Board to host system

4 RXD data from host system to Main Board

a. The “square” plated through-hole designates pin 1 on the Main Board.

Watertrap Switch Connection

Watertrap switch connection is via a 2-pin Molex connector on the Main Board.

Pump

The pump is mounted on the Main Board. The pump wiring harness is connected to the Main Board via a 2-pin connector (Molex P/N 22-01-3027).

The pump wiring meets typical insulation standards but does not meet patient isolation requirements. If the pump must be moved to a different location, patient isolation requirements must not be compromised. Refer to Section 6, Regulatory, for additional regulatory and safety information.

Watertrap Receiver

The internal space available in the host monitor must be considered when incorporating the watertrap receiver into the host system design. To accommodate various OEM dimensions, two watertrap receivers are offered: long and short. The long watertrap receiver requires more intrusion into the host monitor but the watertrap does not protrude as far externally from the host chassis than with the short watertrap receiver.

Page 16 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Section 2 - LC101 Module Interface

Watertrap Receiver Switch

The watertrap receiver switch is wired in the “normally open” conﬁguration.

The watertrap receiver switch connects directly to the Main Board via a wiring harness and connector. The watertrap receiver switch assembly is equipped with a 2 pin connector (Molex P/N 22-01-3027) which electrically connects directly to the Main Board at J102.

The watertrap receiver switch wiring meets typical insulation standards but does not meet patient isolation requirements. When applicable, harness routing must not violate patient isolation requirements. Refer to Section 6, Regulatory, for additional regulatory and safety information.

Exhaust Tubing

In the event of an exhaust tubing malfunction, gas buildup can occur within the host system.

WARNING To protect against potentially ﬂammable gas buildup, the tubing must be

single-fault protected. Refer to Section 6, Regulatory, for additional regulatory and safety information.

Welch Allyn OEM Technologies Conﬁdential Page 17

LC101 CO2 Module OEM Implementation Manual

Page 18 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Section 3

LC101 Calibration

The LC101 Module requires periodic user calibration to adjust offset voltages and calibration constants used by the internal C-Cap bench. There are two types of calibration, each supported in the LC101 software protocol:

• Zero Calibration

•Two-Point User Calibration

Zero Calibration

The Zero Calibration adjusts the offset voltage used by the C-Cap to generate the CO2 values and the IR source current. The required frequency of Zero Calibration depends on the amount

and type of usage, and may be typically required every two weeks. The LC101 does not monitor the elapsed time between calibrations, nor does it alert the host when calibration is needed. It is up to the host system and the end-user to determine when calibration is required.

The procedure requires the use of clean, dry air (0% CO2) at room/ambient temperature. In order to provide the 0% CO used to absorb CO eliminates CO Allyn OEM Technologies.

The scrubber is designed to be attached directly to the Welch Allyn OEM Technologies watertrap by the user before a Zero Calibration. The scrubber is removed after successful calibration. The scrubber has a shelf life of approximately one year. Although the scrubber is considered reusable, its effective life depends on application and exposure to CO

concentration in the zero reference gas and will alert the host system, when polled for

status, if a problem exists with the sample zero gas.

from room air. The scrubber contains a chemical which reacts with and

as it is drawn through the scrubber. The CO2 scrubber is available from Welch

, an external device, called a “CO2 scrubber” (or CO2 absorber), is

. The LC101 monitors the

Welch Allyn OEM Technologies Conﬁdential Page 19

LC101 CO2 Module OEM Implementation Manual

To get an accurate calibration, the LC101 needs to be operating for at least 5 minutes in measurement or autorun mode with the scrubber installed. The LC101 internally monitors the run time and will not allow a Zero Calibration if the run time requirement has not been met.

The LC101 monitors the calibration progress and provides a “Calibration OK” (or “not OK”) message to the host system when polled for status. See the LC101 Software Protocol and the Zero Calibration Commands and Responses for more detail. After a successful Zero Calibration, the LC101 updates the zero residual offset constants located in the LC101 C-Cap EEPROM Memory and the IR source current.

Zero Calibration Procedure

Equipment needed:

• watertrap

•CO2 scrubber (or 0% CO2 medical-grade gas source; see the Two-Point User Calibration procedure for pressurized gas setup)

To Perform a Zero Calibration:

The user is required to apply a 0% CO2 gas, or “zero” gas, during the steps of a Zero Calibration.

To perform Zero Calibration, the user must follow the Original Equipment Manufacturer’s procedure typically provided in the Operator’s Guide or User Service Manual.

1. Select a well ventilated room to perform the calibration.

2. Make sure the LC101 has been operating for at least 5 minutes prior to the Zero Calibration.

3. Attach the CO2 scrubber to the watertrap inlet according to the CO2 scrubber “Directions for Use” (or attach a 0% medical-grade gas source). Now let the LC101 operate for one

minute.

4. After approximately one minute, observe the CO2 reading. The CO2 reading should be between 0.0% - 0.3% with well-ventilated room air.

5. Proceed with the zero gas phase of the calibration as deﬁned by the host system.

6. Disconnect the CO2 scrubber (or gas source) from the watertrap after the zero gas calibration.

Page 20 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Section 3 - LC101 Calibration

Two-Point User Calibration

NOTE Before performing a Two-Point User Calibration, a separate Zero Calibration must be

performed ﬁrst. It is also recommended that both calibrations be performed at 75ºF in order to maintain accuracy over the Module’s operating temperature range.

The Tw o-Point User Calibration, or User Calibration, updates two of the gas calculation constants used to generate the CO

amount and type of usage. Typically it may be required every six months. The LC101 does not monitor time between calibrations, nor does it alert the host when calibration is needed. It is up to the host system and the end-user to determine when calibration is required.

To get an accurate User Calibration, the LC101 needs to be operating for at least 5 minutes in measurement or autorun mode. The LC101 internally monitors the run time and will not allow a User Calibration if the run time requirement has not been met.

To perform the User Calibration, the host is required to supply a calibration date, a span gas concentration, and indicate the gas concentration being applied to the LC101 Module (0% or the span gas).

values. The required frequency of User Calibration depends on the

The OEM typically provides a User Calibration Kit to the end user containing a CO2 reference gas with regulator, scrubber, directions for use, adapter, and tubing.

The LC101 monitors the User Calibration progress and provides a “Calibration OK” (or “not OK”) message to the host system after successful calibration when polled for status. See the LC101 Software Protocol and the User Calibration Commands and Responses for more detail. After a successful User Calibration, the LC101 updates the User Calibration History Queues located in the LC101 C-Cap EEPROM Memory.

Zero and User Calibration dates should be user accessible via a host service screen or other means.

Welch Allyn OEM Technologies Conﬁdential Page 21

LC101 CO2 Module OEM Implementation Manual

Two-Point User Calibration Procedure

Illustration of gas canister, regulator and pneumatic circuit

Equipment needed:

• calibration gas canister (8 – 12% CO2, ±0.02%, balance air or nitrogen)

Regulator

Te e

On/Off

10%

CO2

Bal. N2

Free Flow Away From Monitor Input

Water Trap

To Monitor

Two-Point User Calibration Equipment Setup

• gas valve and non-silicon tubing

• sample elbow or tee

•ﬂow meter

• sample line

•watertrap

•CO2 scrubber (or 0% CO2 medical-grade gas source)

CAUTION Make sure that the tubing used to connect the gas supply to the LC101 does

NOT contain silicon. Silicon tubing absorbs CO

and affects the stability of

the gas concentration, thereby reducing the accuracy of the procedure.

Page 22 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Section 3 - LC101 Calibration

To Perform a Two-Point User Calibration:

The user is required to apply a 0% CO2, or “zero” gas, and also apply a gas of known CO2 concentration (referred to as “span” gas) during the various steps of a Two-Point User

Calibration. The user is required to manually enter the value of the Span Gas applied into the Monitor.

To perform the Two-Point User Calibration, the user must follow the Original Equipment Manufacturer’s procedure typically provided in the Operator’s Guide or User Service Manual. (Refer to illustration on

page 22.)

1. Select a well-ventilated room to perform the calibration.

2. Let the LC101 run for at least 5 minutes prior to calibration.

3. For the “Sample Zero Reference Gas” step, attach the CO2 scrubber to the watertrap inlet according to the CO

scrubber “Directions for Use” (or use a 0% medical-grade gas source).

4. Proceed with the zero gas phase of the calibration as deﬁned by the host system. Disconnect CO2 scrubber (or 0% gas source) from the watertrap after the zero gas phase and prior

to the next calibration step.

5. For the “Sample Span Reference Gas” phase of the calibration, provide a medical-grade gas source with a known CO

concentration between 8% and 12%, regulated to a pressure

between 5 and 7 psi.

NOTE Do not apply any pressure directly to the Module inlet or outlet.

6. Introduce a steady stream of CO2 gas. Set and monitor the ﬂow rate to approximately

liter/minute (±10%). To verify ﬂow, place the bleed line of the calibration sample line in a

1 glass of water. If bubbles emerge, gas supply is sufﬁcient. If no bubbles emerge, there is an insufﬁcient supply of gas.

7. Connect a sample line from the sample elbow, or Tee, as shown above, to the Monitor’s watertrap inlet. Make sure the bleed line is directed away from the monitor. Allow the refer ence gas to ﬂow for at least one minute.

8. Sample the Span Reference Gas.

9. After the Two-Point User Calibration steps have been followed, disconnect the LC101 from the gas supply and test setup.

10. A veriﬁcation may be performed using the same gas delivery set up. Verify the observed CO

gas reading is within 3 mmHg or 10%, whichever is greater, of the CO2 value of the test

gas supplied. (If not, refer the user to the appropriate troubleshooting information.)

Welch Allyn OEM Technologies Conﬁdential Page 23

Troubleshooting

• Make sure that the room is well ventilated. CO2 readings may be elevated in a closed room.

• Conﬁrm that the calibration gas is of known concentration. If the CO2 readings are consistently elevated or depressed, the calibration gas may be suspect. Try another

gas source.

• Make sure that the CO2 module was properly set up and operating for the required minimum period before testing.

• Check for air leaks in the pneumatic tubing and connections. Repair or replace as needed.

• Conﬁrm that the sample gas ﬂow rate is greater than the CO2 module’s pump ﬂow rate.

• Conﬁrm that silicon tubing is not used in the procedure (silicon absorbs CO2 which affects the gas concentration stability and accuracy of the procedure).

LC101 CO2 Module OEM Implementation Manual

Page 24 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Section 4

Host/Module Communications

The LC101 Module is a command driven slave device capable of communicating with a host system over an asynchronous serial communication line. After the host system commands the LC101 Module to begin transmission of CO sends periodic packets without additional intervention by the host system. The host system must initiate all other communication with the LC101 Module.

waveform and breath data packets, the Module

The LC101 Module and the host system are referred to as the “Module” and “host” in the remainder of this section.

Communication Interface

• 9600 baud rate

• full duplex

• asynchronous using standard non return to zero (NRZ) format.

{1 start bit 7 or 8 data bits even parity 1 stop bit}

• Receive data input (RxD) is the buffered input of a 74HC14. A pull up is provided on the Module so it can be driven by an open collector source.

•Transmit data output (TxD) is the collector of a 2N4401 transistor driven with a 10 K base resistor from the output of a 74HC14. A weak pull up is provided to source a CMOS load.

• Module power and communications are provided at J101.

Welch Allyn OEM Technologies Conﬁdential Page 25

LC101 CO2 Module OEM Implementation Manual

System EEPROM

The system EEPROM contains manufacturing and operational data that is necessary for the LC101 Module to function. A limited number of these system parameters may be speciﬁed by the OEM. These include

• data format

• start up mode

• initial pump ﬂow rate

The data format options are 7 and 8 data bits (default is 7E1).

The start up mode options are auto run, measurement, standby and fault (default is standby).

The initial pump ﬂow rate option allows the host to specify the default pump ﬂow rate in milliliters per minute (default is 150 ml/min).

Packet Structure

Transmission of host commands and Module responses is via packets. The following byte structure represents a packet.

Packet format:

< start of text (STX) 02h

X identiﬁer 1*(ASCII)

yy CCITT/CRC code 2*(ASCII)

> end of text (ETX) 03h

ASCII characters have values in the range of 00h to 7Fh. The identiﬁer is case sensitive. Characters between 00h and 20h are reserved as control characters.

Tr ansmission of all packets starts with a “<” STX control character and ends with a CCITT/CRC code and “>” ETX control character. Between STX and ETX is an identiﬁer and n bytes of ASCII data. The length of the packet is deﬁned by the identiﬁer character. Packet length cannot exceed 25 bytes with a maximum of 20 bytes of data allowed. Packets without the STX control character are ignored. The CCITT/CRC code is calculated on values between STX and CCITT/CRC code.

data n(hex char)

Example:

02h X xxn yy 03h

Page 26 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Section 4 - Host/Module Communications

Host Commands

The host communicates to the Module via commands. These include:

• mode commands to request a change in the operating mode.

• simple commands to request data or a status change. Data is not sent with these commands.

• conﬁguration commands to specify custom system settings. Data is sent with these commands.

• calibration commands to request a Zero or User Calibration sequence. Data is sent with these commands.

Mode Commands

Mode commands allow the host to put the Module into one of the three operating modes.

Host Command Description

<M24> Enter auto run mode

To start automatic sampling and data packet transmission at default intervals of realtime CO2 waveform and breath data. A watertrap removal causes the Module to wait for a watertrap insertion. This is

the preferred operating mode since temporary watertrap removal and replacement is typical in normal operation.

<M23> Enter measurement mode

Same as auto run mode except for sidestream watertrap removals. Instead of waiting for watertrap insertion, the sensor’s activity is halted and the Module reverts to the standby mode and requires a new <M23> host command to restart measurement.

<M21> Enter standby mode

Used when a low power standby state for the Module is desirable. This prolongs the life expectancy of the IR source, since this component is disabled in this mode.

No more than two mode commands should be issued in any ﬁve-second period.

The Module automatically reverts to fault mode if a Module or sensor fault occurs. A fault message is sent via the status response by the Module to the host when polled for status.

Welch Allyn OEM Technologies Conﬁdential Page 27

LC101 CO2 Module OEM Implementation Manual

Simple Commands

Simple commands instruct the Module to send Module data or EEPROM data and to reset the Module software or reset sensor error.

Host Command Description

<C00> Request and conﬁrm operating mode and Module status

<C20> Request software version

<C21> Request hardware version

<C22> Request ambient barometric pressure

<C23> Request sensor temperature

<C26> Request single CO2 measurement

<C27> Request single breath data packet

<C2E> Request current set ﬂow rate

<C31> Request sensor EEPROM revision #

<C32> Request sensor manufacturer code

<C33> Request sensor serial #

<C3A> Request last calibration date

Page 28 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Section 4 - Host/Module Communications

Conﬁguration Commands

Conﬁguration commands instruct the Module to temporarily modify speciﬁc default settings for measurement criteria. A new pump ﬂow rate may also be speciﬁed. The host does not have to command the Module into the unprotected mode prior to issuing a new ﬂow rate command.

A description of these commands is included in the following table.

Host Command Description

<Nxx> Change CO2 waveform update rate

Allows the host to specify how often the Module sends a CO2 waveform data packet. The Module generates a CO2 measurement every 31msec. The maximum update rate is 31 msec. The host may program the rate to xx increments, where xx is the number of 31msec increments per packet.

<Nxx> where xx (ASCII) deﬁnes the CO2 waveform update rate

based on the number of 31msec increments. xx range 00h to FFh xx default 01h, 31 msec interval

Examples:

<N01> send a CO2 waveform data packet every 31 msec (1 × 31

msec) <N05> send a CO2 waveform data packet every 155 msec (5 ×

31 msec) <NFF> send a CO2 waveform data packet every 7.9 seconds

(255 × 31 msec) <N00> stop sending waveform data

<Axx> Change breath data clear rate

Allows the host to specify how long the Module waits for a new breath data packet before clearing the breath data (ETCO2 = 00h / RR = 00h / InsCO2 = 00h).

<Axx> where xx (ASCII) deﬁnes the “no breath” timeout in sec-

onds xx range 10 to 60 s (0Ah to 3Ch) xx default 0Fh, clear breath data after 15 s of “no breath”

Example:

<A0A> clear the breath data after 10 seconds of “no breath”

Welch Allyn OEM Technologies Conﬁdential Page 29

LC101 CO2 Module OEM Implementation Manual

<Oxx> Change breath data update rate

Allows the host to specify how often the Module sends a breath data packet.

<Oxx> where xx (ASCII) is converted to a 8 bit binary number (yyzz

zzzz) with yy deﬁning how often the breath data is

updated. If yy = 00 binary, Breath data packet update rate is deﬁned by

zzzzzz, where zzzzzz is in tenths of seconds. The 6

lower bits = (seconds × 10).

to even values.

If yy = 01 binary, Breath data packet update rate is every breath

where zzzzzz = doesn’t matter.

Exception: If the “no breath” condition occurs, data is sent at 1 second increments.

If yy = 10 binary, Breath data update rate is when the data changes,

where zzzzzz = doesn’t matter.

Exception: If after 15 seconds the breath data has not changed, data is sent after the next breath. This does not guarantee a 15 second update; however, if the “no breath” condition has occurred, the “no breath” timeout takes precedence.

Exception: If the “no breath” condition occurs, data is sent at 1 second increments.

If yy = 11 binary, Not deﬁned.

Examples

<O05> send a breath data packet at .6 s interval (Odd values

<O40> send a breath data packet every breath <O80> send a breath data packet every time the data changes

Special case:

<O00> no breath data sent (Note: Continuous CO2 mode would

rounded up)

use this command.)

Odd values are rounded up

Page 30 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

<Qxxy> Function enable

Allows the host to enable or disable functions listed below. <Qxxy> where xx (ASCII) is the compensation and y (ASCII) is

ON/OFF status. xx =

00h O2 compensation

01h N2O compensation

02h desﬂurane compensation 08h water vapor compensation 09h BTPS compensation 0Ah baseline compensation 7Fh protect mode

y =

00 binary ON 01 binary OFF 3Fh current ON/OFF status

Example

<Q011> compensate the CO2 waveform data for N2O

<Q7F0> turn off protect mode (to allow certain commands)

Section 4 - Host/Module Communications

<F20yy> Change pump ﬂow rate

Allows the host to specify the pump ﬂow rate in milliliters per minute.

<F20yy> where yy (8 bit) is the current pump ﬂow rate.

yy range 90 – 200 ml/min (5Ah – C8h) yy default 175 ml/min (AFh)

Example

<F205A> set the pump ﬂow rate to 90 ml/minute Note: Using this command to set a desired ﬂow rate, the pump ﬂow

rate will revert back to default settings upon power up. The ﬂow rate can be ﬁxed in the EEPROM to a speciﬁc default setting. See EEPROM Map for location details.

<C80> Request software reset

Allows the host to reset the Module. This command is only accepted if the Module is in the unprotected mode. See Function enable <Qxxy>.

Welch Allyn OEM Technologies Conﬁdential Page 31

LC101 CO2 Module OEM Implementation Manual

Calibration Commands

Calibration commands instruct the Module to update the gas calculation or the zero offset constants used to generate the CO

are stored in EEPROM memory. Data is required with these commands. There are two types of calibration: Two-Point User Calibration and Zero Calibration.

Two-Point User Calibration

TheTw o-Point User Calibration updates two of the gas calculation constants used to generate the CO

values. To perform a User Calibration, the host is required to supply a calibration date and a

span gas concentration.

When performing a User Calibration, the LC101 Module must ﬁrst be in either Unprotected 'Measurement' or 'Autorun' mode. During the calibration, CO

be sent to the host.

To get an accurate calibration, the LC101 Module needs to be operating for at least 5 minutes in measurement or autorun modes. The LC101 will not allow a calibration if this requirement has not been met. In addition, the calibration should be performed at room/ambient temperature.

values. At the end of a successful calibration, new constants

waveform and Breath data will still

Host Command Description

<Lmmddyyyy> Update calibration date.

Allows the host to enter a new calibration date from user input into EEPROM memory.

<Lmmddyyyy> mm = month, dd= day, yyyy= year Note: The mmddyyyy ﬁelds are decimal values.

Example

<L01012000> calibration date = January 1, 2000

<Gxx> Update span gas concentration.

Allows the host to enter a gas concentration value from user input. <Gxx> xx = percent CO2 x 16.

Example

<GA8> span gas concentration = 10.5%

<C10> Sample zero reference gas.

<C11> Sample span reference gas.

<C13> Abort calibration

After a successful calibration, the Module updates the User Calibration History Queues located in the

C-Cap EEPROM Memory Map

Page 32 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Zero Calibration

The Zero Calibration adjusts the IR source current to compensate for detector output changes. The host is required to inform the LC101 Module when to start sampling 0% CO

When performing a Zero Calibration, the LC101 Module must ﬁrst be in either Unprotected 'Measurement' or 'Autorun' mode. During the calibration, CO

be sent to the host.

Host Command Description

<C12> Perform Zero Calibration

<C13> Abort Calibration

Section 4 - Host/Module Communications

gas.

waveform and Breath data will still

After a successful Zero Calibration, the Module updates the zero residual offset constants located in the

C-Cap EEPROM Memory Map

Module Responses

The host must initiate all communication with the Module with the exception of periodic CO2 waveform and breath data packets. The type of response sent is determined by the type of host command. Responses include:

• status responses

• mode command responses

• simple command responses

• conﬁguration command responses

• calibration command responses

Welch Allyn OEM Technologies Conﬁdential Page 33

LC101 CO2 Module OEM Implementation Manual

Status Responses

Status responses are data packets that communicate Module, sensor and system status. The status response also serves as an acknowledgement for mode commands.

Status response packet format:

< STX 02h

X identiﬁer 1*(ASCII)

xx mode 2*(ASCII)

yy message 2*(ASCII)

zz CCITT/CRC code 2*(ASCII)

> ETX 03h

NOTE: To simplify the Module status response examples that follow, the CRC data (zz) is

assumed to be included with the ETX character (>).

Status Response Mode Byte

The format of the Mode byte is as follows:

<Sxxyy> where S = Identiﬁer

xx = Mode

yy = Status message

(1 byte = 1 ASCII character)

(2 Hex digits = 2 ASCII characters)

Status Response Mode Byte - Format Summary

bit 7* bit 6* bit 5* bit 4** bit 3** bit 2 bit 1 bit 0

Status Response xx

<S61yy> Standby 0 1 1 0 0 0 0 1

<S63yy> Measurement 0 1 1 0 0 0 1 1

<S64yy> Autorun 0 1 1 0 0 1 0 0

<S65yy> Fault 0 1 1 0 0 1 0 1

Mode

8 4 2 1 8 4 2 1

*Bits 5 and 6 will always be set to 1; Bit 7 will always be set to 0.

**Bits 3 and 4 are always zero as there are only 4 modes (values 0, 2, and 6 to 31 are undeﬁned).

Page 34 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Section 4 - Host/Module Communications

Status Response Message Byte <Sxxyy> where yy =

Status message (2 Hex digits = 2 ASCII characters)

Status Response message byte (yy) contains:

• generic status messages (00h – 06h)

•fault status messages (10h – 85h)

Refer to the Status Message Table at the end of this section for message descriptions. More detailed information about fault messages is also available in Appendix C, Error Messages & Recovery.

Mode Command Responses

Host Command Module Response Module Response Format

<M21> Enter standby mode

<M23> Enter measurement mode

<M24> Enter auto run mode

<S6106> xx = mode

yy = message

Example:

<S6106> 61= Standby mode 06= Acknowledge mode command

<S6306> xx = mode

yy = message

Example:

<S6306> 63= Measurement mode 06= Acknowledge mode command

<S6406> xx = mode

yy = message

Example:

<S6406> 64= Autorun mode 06= Acknowledge mode command

Welch Allyn OEM Technologies Conﬁdential Page 35

LC101 CO2 Module OEM Implementation Manual

Simple Command Responses

Host Command Module Response Module Response Format

<C00> Request Module status

<C20> Request software version

<C21> Request hardware version

<C22> Request stored ambient baro-

metric pressure reading from absolute pressure transducer

<Sxxyy> xx = mode

yy = message

Example:

<S6400> 64= Autorun mode 00= OK status

<Vxxxmmddyyyy> xxx = version #

mm = version month dd = version day yyyy = version year

Example:

<V13010231998> version = 1.30 date = 10-23-1998

<Hxx> xx = hardware version

Example:

<H25> hardware version = 2.5

<Lxxxx> xxxx = amb baro pressure mmHg

Examples:

<L02E9> amb baro pressure = 745 mmHg <L02F8> amb baro pressure = 760 mmHg

<C23> Request sensor temperature

<Txx>

xx = (temperature x 4) oC

Example:

<T2A>

temperature = (42/4) = 10.5oC

<C26> Request single CO2 packet

<wxxyy> xxyy = ppCO2 x 256

CO2 = 16 bit binary integer

Example:

<w1C5B> waveform = 28.35

Page 36 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Section 4 - Host/Module Communications

<C27> Request single breath packet

<C2E> Request current pump ﬂow rate

<C31> Request sensor EEPROM revi-

sion #

<zxxyyww> xx = ETCO2 mmHg

yy = RR bpm ww = InsCO2 mmHg

Example:

ETCO2= 32

RR= 21 InsCO2= 0

<Bxxxx> xxxx = pump ﬂow rate ml/min

Example:

<B0096> ﬂow rate = 150 ml/min

<Rxx> xx = revision #

Example:

<R02> revision # = 2

<C32> Request sensor customer code

<C33> Request sensor serial #

<C3A> Request last calibration date

<Ixx> xx = customer code

Example:

<I00> customer code = 00

<Nxxxx> xxxx = serial #

Example:

<N34C2> serial # = 13506

<Dmmddyyyy> mm = month

dd = day yyyy = year

Example:

<D06041998> last cal date= 6/4/1998

Welch Allyn OEM Technologies Conﬁdential Page 37

LC101 CO2 Module OEM Implementation Manual

Conﬁguration Command Responses

Conﬁguration responses are data packets sent by the Module to the host at programmed intervals. A single host measurement or auto run mode command initiates unsolicited transmission of CO packets is either deﬁned by the host via a conﬁguration command or the host may use the default setting.

Module Response Module Response Format

waveform and breath data packets. The programmed interval between

<Wxxyy> Unsolicited CO2 waveform packet at programmed interval

<Zxxyyzz> Unsolicited breath data packet at programmed interval

see below

<Wxxyy>, CO2 Waveform Data

Includes 4 bytes of CO2 waveform data that are sent at the programmed interval during measurement and auto run modes.

<Wxxyy> where xxyy:

xxyy CO2 waveform data mmHg × 256 4*(ASCII)

range: 0 – 99.996 mmHg (0000h – 63FFh)

Example:

CO2 = 37.50 mmHg

{STX} “W” xx yy CCITT/CRC {ETX} waveform byte string

0x25 0x80 0x79 {STX}W258079{ETX}

02h 57h 32h35h 38h30h 37h39h 03h

Page 38 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Section 4 - Host/Module Communications

<Zxxyyzz>, Breath Data

Includes 6 bytes of breath data that are sent at the programmed interval during measurement and auto run modes.

<Zxxyyzz> where xxyyzz:

xx ETCO2 mmHg 2*(ASCII)

yy RR bpm 2*(ASCII)

zz InsCO2 mmHg 2*(ASCII)

Range:

ETCO

0 – 99 mmHg (00h – 63h)

RR 0 – 250 bpm (00h – FAh)

InsCO

Example:

0 – 99 mmHg (00h – 63h)

ETCO2 = 39 mmHg / RR = 12 bpm / InsCO2 = 0 mmHg

{STX} “Z” xx yy zz CCITT/CRC {ETX} breath byte string

0x27 0x0C 0x00 0x1A {STX}Z270C001A{ETX}

02h 5Ah 32h37h 30h43h 30h30h 31h41h 03h

Additional Conﬁguration Command Responses

Host Command Module Response Description

<Axx> Change breath data clear rate

<Nxx> Change waveform update rate

<axx> response = echo data ﬁeld

<nxx> response = echo data ﬁeld

<Oxx> Change breath data update rate

<Qxxy> Function enable

<F20yy> Change pump ﬂow rate

<C80> Request software reset

<oxx> response = echo data ﬁeld

<qxxy> response = echo new/current status

<F20yy> response = echo data ﬁeld

no response

Welch Allyn OEM Technologies Conﬁdential Page 39

LC101 CO2 Module OEM Implementation Manual

Calibration Command Responses

Host Command Module Response Module Response Format

<Lmmddyyyy> Update calibration date

<Gxx> Update span gas concen-

tration

<C10> Sample zero reference gas

<Sxxyy> xx = mode

yy = message

Example:

<S6424> 64= Autorun mode 24= Cal. ready for next step

Example:

<S6421> 64= Autorun mode 21= Cal. already in progress

<Sxxyy> xx = mode

yy = message

Example:

<S6424> 64= Autorun mode 24= Cal. ready for next step

Example:

<S6422> 64= Autorun mode 22= Cal. not in progress

<Sxxyy> xx = mode

yy = message

Example:

<S6425> 64= Autorun mode 25= Cal. in progress

<C11> Sample span gas

<Sxxyy> xx = mode

yy = message

Example:

<S6425> 64= Autorun mode 25= Cal. in progress

<C13> Abort calibration

<Sxxyy> xx = mode

yy = message

Example:

<S6400> 64= Autorun mode 00= OK (operation aborted)

Refer to the Status Message Code Table and the Host Command/Module Response Overview Ta ble at the end of this section for message descriptions.

Page 40 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Software Protocol

Packets

• Module must respond within 1 second after receiving a host command (50 msec typical response time).

• There is no minimum time interval between packets.

• Host must request Module status periodically to conﬁrm the fault/OK status of the Module and sensor.

• Host must either receive a Module response or have exceeded the Module response timeout of 1 second before issuing a new command.

• There are no restrictions when switching from mode to mode.

•A packet that interrupts another packet causes the interrupted packet to be ignored.

• An incomplete or incorrectly formatted packet is ignored.

• Status messages have identical meanings in all operating modes.

Section 4 - Host/Module Communications

Faults

WARNING The host should not assume that the Module is faultless if CO2 waveform and

breath data is being sent. Data response packets may be communicated when the Module is in a non-fatal fault, or soft fault state.

• If a fault occurs and the host issues a new mode command that is different from the current mode, the Module responds with either a hard fault status and ignores the mode command, or retries by attempting to clear the fault.

• If the Module is in a soft fault state, the host should issue a new measurement mode command to attempt to clear the fault.

•A fault condition may leave the Module in the fault mode indicated by a <Sz5yy> status response. For <Sz5yy>, yy is the status message and z is the other status.

Module Resets

External Resets (Initiated by the Host System)

• Software Reset - The host may command a software reset using the <C80> command while the Module is unprotected. After the reset, the Module returns to its EEPROM default settings.

• Reset - If the host holds the receive data line in a break condition for greater than 10 msec, but less than 500 msec, the microprocessor is forced into reset. After the reset, the Module returns to its EEPROM default settings and starts up in the standby mode. The Module can respond to host communication 2 seconds after a reset.

Welch Allyn OEM Technologies Conﬁdential Page 41

LC101 CO2 Module OEM Implementation Manual

• Hard Reset - If the host holds the receive data line in a break condition for more than 500 msec, the microprocessor is forced to enter the boot mode when the break condition is released. The microprocessor boot mode is used to install new software into the FLASH device.

Internal Resets (Initiated within the LC101 Module)

• Watchdog Reset - Watchdog reset is caused by a watchdog timeout. After a watchdog reset, the Module responds to a <C00> Request Status command with the status response <S6540> (fault mode, watchdog timeout). The host must issue a reset to recover from a watchdog reset.

• Self Reset - Caused by a condition other than watchdog timeout. After self reset, the Module responds to a <C00> Request Status command with status response <S6500> (fault mode, status OK). The host must issue a reset to recover from self reset.

System Behaviors - Dynamic Communications

Status Requests

The host must poll the LC101 Module periodically to determine status.

requests, the host can report any problems seen by the LC101 Module.

By sending status

WARNING The host should NOT assume that if waveform data is being sent by the LC101

Module, the LC101 Module is not reporting any errors. It is possible to report a non-fatal error condition even when waveform data is being sent.

When the LC101 Module is in 'Fault' mode, it will report the error that caused the fault.

CO2 Waveform Data

During 'Measurement' and 'Autorun' modes, the LC101 Module sends a CO2 waveform packet every 31 msec (or every xx number of 31 msec increments if the Nxx command was used). Also,

the LC101 Module will be responding to the host's periodic requests for status data. The host may experience a delay in the waveform packet timing, but the delay will be made up by the increased delivery speed of the next few packets.

If waveform data ever stops being sent, the status response will inform the host of a fault condition. The fault condition could leave the LC101 Module in 'Fault' mode (i.e., <S65yy>) or the LC101 Module could remain in 'Measurement' or 'Autorun' mode (e.g., if a "No Watertrap" status message is returned).

"No Watertrap" Status Messages

During 'Measurement' and 'Autorun' modes, the LC101 Module will continually verify that a watertrap is present. If the watertrap is NOT detected and a status request is received, the status message "No Watertrap" will be returned. No waveform data will be sent at this time. Regardless of the operating mode, this status message will be returned until a watertrap is inserted, the host sends a mode change command, or a fault event is detected.

Page 42 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Section 4 - Host/Module Communications

If the LC101 Module was in 'Measurement' mode and the watertrap was not detected for 30 seconds, the Module will switch to 'Standby' mode. As before, the LC101 will return the "No Watertrap" status message (i.e., <S6116>) in response to any status request. Even in 'Standby' mode, this status message can only be eliminated if a watertrap is inserted, the host sends a mode change command, or a fault event is detected.

In 'Autorun' mode, removing the watertrap does not change the mode to 'Standby'. Instead, the LC101 Module will stay in 'Autorun' mode. 'Autorun' mode should be used when it is desirable that the host not be required to reinitiate CO

activity when a watertrap is replaced.

If the LC101 Module enters the 'Standby' mode via a mode change command or initialization, it will NOT examine if the watertrap is present. Consequently, the "No Watertrap" status message will NOT be returned during this time.

Welch Allyn OEM Technologies Conﬁdential Page 43

LC101 CO2 Module OEM Implementation Manual

Status Message Code Table

Code (hex) Suggested Message

00 Status OK 01 Invalid Command 02 Invalid Data 03 Unprotected or Unprotected Operation 06 Acknowledge Mode Command 11 CO2 Sensor Start Up In Progress

15 Vacuum Offset too Large 16 No Watertrap 17 Watertrap Or Cannula Occlusion 18 Exhaust Occlusion Or Pneumatic Leak 21 Calibration Already in Progress 22 Calibration Not in Progress 23 Low Run Time 24 Calibration Ready For Next Step 25 Calibration in Progress 26 Calibration OK 27 Calculation Error 28 Unable to Perform Calibration, Parameters missing 29 Unable to Perform Calibration, Data Error 2A Bad Calibration CRC 40 Watchdog Error 44 System EEPROM CCITT/CRC Error 46 System FLASH ROM CCITT/CRC Error 47 System Communication Error (LC101 internal) 4B System External RAM Error 4C System RAM Error 4D System FLASH ROM Error/Checksum 4E Stack Overﬂow Error 4F System SW Error/Main Program 51 Manufacturer ID Mismatch 57 Sensor Not Found 60 CO2 Sensor EEPROM Error/Revision #

65 CO2 Sensor EEPROM Error/Read/Write

66 CO2 Sensor EEPROM Error/CCITT/CRC Code

70 CO2 Sensor Temperature Too High

71 CO2 Sensor Temperature Too Low

80 Pump Failure 81 Unexpected Reverse Flow 82 Unexpected Forward Flow 84 Barometric Pressure Too High 85 Barometric Pressure Too Low

Page 44 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Section 4 - Host/Module Communications

Host Command/Module Response Overview Table

Command Command Description Response Response Description

<M21> Enter standby mode <Sxx06> Acknowledge with Module status

<M23> Enter measurement mode <Sxx06> Acknowledge with Module status

<M24> Enter auto run mode <Sxx06> Acknowledge with Module status

(Invoked with enter measurement or auto run mode command)

<C00> Request Module status <Sxxyy> Acknowledge with Module status

<C10> Sample Zero Reference Gas <Sxx25> Status 25 = Cal in Progress

<C11> Sample Span Reference Gas <Sxx25> Status 25 = Cal in Progress

<C12> Perform Zero Calibration <Sxx25> Status 25 = Cal in Progress

<C13> Abort Calibration <Sxx00>

<C20> Request software version <Vxxxmmd-

<C21> Request hardware version <Hxx> Hardware version # sent

<C22> Request ambient barometric

pressure

<C23> Request sensor temperature <Txx> Sensor temperature sent

<C26> Request single CO2 packet <wxxyy> CO2 measurement sent

<Wxxyy> CO2 waveform data packets sent at

programmed interval

<Zxxyyww> Breath data packets sent at pro-

grammed interval

Status 00, ok (operation aborted)

<Sxx22>

dyyyy>

<Lxxxx> Ambient barometric pressure sent

Calibration not in Progress

Version # with month, day, year sent

<C27> Request single breath data

packet

<C2E> Request current pump ﬂow rate <Bxxxx> Current pump ﬂow rate sent

<C31> Request sensor EEPROM revi-

sion #

<C32> Request customer code <Ixx> Sensor customer code sent

<C33> Request sensor serial # <Nxxxx> Sensor serial # sent

<C3A> Request last calibration date <Dmmd-

<C80> Software reset No response

<Axx> Specify breath data timeout <axx> Data ﬁeld echoed

<F20yy> Specify pump ﬂow rate <f20yy> Command echoed

<Gxx> Update Span Gas <Sxx24> Status 24 = Cal Ready for Next Step

<Nxx> Specify CO2 waveform data

<Oxx> Specify breath data packet inter-

<Qxxy> Specify measurement compen-

Update Calibration Date. <Sxx24> Status 24 = Cal Ready for Next Step

packet interval

val

sation ON or OFF, SW reset

<zxxyyww> Breath data packet sent

<Rxx> Revision # sent

Last calibration date sent

dyyyy>

<nxx> Data ﬁeld echoed

<oxx> Data ﬁeld echoed

<qxxy> New and previous measurement

compensation settings echoed

Welch Allyn OEM Technologies Conﬁdential Page 45

LC101 CO2 Module OEM Implementation Manual

System Component Status

The following table lists the state of the system components based on the LC101 Module’s mode.

Mode IR Source Pump CO2 Waveform and Breath Data

Fault OFF OFF NO

Standby OFF OFF NO

Measurement ON ON YES

Autorun ON ON YES

Page 46 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Section 5

Pneumatic Operation

The LC101 Module Pneumatic System is responsible for controlling the ﬂow to the sidestream bench in order to measure the patient’s CO commanded by the host and keep it within ﬂow speciﬁcations. Conditions such as inlet/exhaust irregularities, internal pneumatic disconnects and pump failures are detected by the Pneumatic System.

level. The Pneumatic System must set the ﬂow as

NOTE All user message handling and recovery procedures for pneumatic events, disconnects

of internal pneumatics and pump failures are the responsibility of the host system.

The LC101 Module and the host system are referred to as the “Module” and “host” in the remainder of this section.

Normal Flow

Normal ﬂow is controlled by the Pneumatic System to remain within +15/-20% of the set ﬂow rate. The host can set a ﬂow rate between 90 ml/min and 200 ml/min using the <F20yy> Change Pump Flow Rate command. The Module responds to a requested ﬂow rate that either exceeds or is less than the ﬂow limits with a <Sxx02> Invalid Data response.

The host can expect stable pump operation during normal ﬂow conditions without additional intervention; however, the host must poll the Module periodically to determine the status.

WARNING The host should not assume that the Module is faultless if CO2 waveform and

breath data is being sent.

Welch Allyn OEM Technologies Conﬁdential Page 47

LC101 CO2 Module OEM Implementation Manual

Pneumatic Events

Pneumatic events which may occur include

• total inlet occlusion

• partial inlet occlusion

• total exhaust occlusion

• partial exhaust occlusion

• barometric pressure out of range

• unexpected reverse ﬂow

• unexpected forward ﬂow

Total Inlet Occlusion

A total blockage in some region of the inlet tubing, or a total inlet occlusion, is typically caused by a kinked or occluded sample line, a fully saturated watertrap or an occluded secondary shutoff pellet. In the event that this condition occurs, the Pneumatic System ramps up the pump speed to achieve a high clearing vacuum (HCV) for 5 seconds. If the occlusion is cleared by this action, the pump returns to normal operation.

If the occlusion is not cleared after 5 seconds, the Module automatically reverts to a hold, or low clearing vacuum (LCV) state, for up to 15 minutes. During this condition, the Module responds to status requests with a <Sxx17> Watertrap or Cannula Occlusion response. If the occlusion is not removed after 15 minutes of LCV, the Module reverts to the standby mode and a new measurement of auto run mode command must be issued to start CO packet transmission.

NOTE Inducing a total inlet occlusion can be useful to check for internal pneumatic leaks.

When the Module goes into the LCV state, typical pump operation remains relatively stable in holding the vacuum.

NOTE However, if there are leaks within the overall system, the pump ramps up and cycles

often to maintain LCV. The Module may possibly toggle between the normal and inlet occluded state depending on the magnitude of the leak. A speciﬁc connection may also be tested by blocking speciﬁc locations in the pneumatics.

waveform and breath data

Partial Inlet Occlusion

A partial blockage of the inlet tubing, or partial inlet occlusion, is typically caused by a partially occluded sample line. In the event that this condition occurs, the Pneumatic System ramps up the pump speed sufﬁciently to sustain the set ﬂow rate. The Module responds to status requests with a <Sxx00> Status OK response.

Page 48 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

A condition of unstable operation may be evident when a partial blockage approaches the occlusion threshold limits, causing the Module to toggle between normal and occlusion states. If the blockage increases enough to completely occlude the inlet tubing, the Module reverts to the total inlet occlusion state.

Section 5 - Pneumatic Operation

Total Exhaust Occlusion

A total blockage of the exhaust tubing, or total exhaust occlusion, is typically caused by an obstructed external exhaust port or clogged internal mufﬂer. In the event that this condition occurs, the Pneumatic System ramps up the pump speed and remains in a high speed/no ﬂow state indeﬁnitely. During this condition, the Module responds to status requests with a <Sxx18> Exhaust Occlusion Or Pneumatic Leak response.

WARNING The Module remains indeﬁnitely in the total exhaust occlusion state if not

commanded by the host.

Partial Exhaust Occlusion

In the event of a partial blockage of the exhaust tubing, the Pneumatic System ramps up the pump speed enough to maintain set ﬂow rates. During this condition, the Module responds to status requests with a <Sxx00> Status OK response.

A condition of unstable operation may be evident when a partial blockage approaches the occlusion threshold limits, causing the Module to toggle between the normal and occlusion states. If the blockage increases enough to completely occlude the exhaust tubing, the Module reverts to the total exhaust occlusion state.

Barometric Out Of Range

If the Module is operated outside the allowable barometric range, the pump is turned OFF and the Module reverts to the fault mode. During this condition, the Module responds to status requests with either a <Sxx84> Barometric Too High response or <Sxx85> Barometric Too Low response.

Unexpected Reverse Flow

This condition occurs when the pneumatic input is connected to a negative pressure source, or vacuum. The ﬂow control circuitry checks the Pneumatic System for this condition prior to turning ON the pump. If a vacuum exists on the inlet prior to the pump starting, the Module reverts to the fault mode. During this condition, the pump is not operational and the Module responds to status requests with <Sxx81> Unexpected Reverse Flow response.

Welch Allyn OEM Technologies Conﬁdential Page 49

LC101 CO2 Module OEM Implementation Manual

Unexpected Forward Flow

This condition occurs when the pneumatic input is connected to a positive pressure source, or ﬂow source. The ﬂow control circuitry checks the Pneumatic System for this condition prior to turning ON the pump. If a positive pressure exists on the exhaust prior to the pump starting, the Module reverts to the fault mode. During this condition, the pump is not operational and the Module responds to status requests with <Sxx82> Unexpected Forward Flow.

Internal Disconnects

Internal disconnects which may occur include

•watertrap receptacle

• sensor inlet/outlet

•ﬂow control circuitry

• pump inlet

• pump exhaust

Watertrap Receptacle

If a pneumatic connection at the watertrap receptacle is loose or has failed, the transmission of CO

waveform and breath data packets is halted. The Module does not report this fault to the

host but clears the breath data based on the default speciﬁed in the <Axx> No Breath Timeout command.

Sensor Inlet/Outlet

If a pneumatic connection at the sensor inlet or outlet is loose or has failed, the transmission of CO

waveform and breath data packets is halted. The Module does not report this fault to the

host but clears the breath data based on the default speciﬁed in the <Axx> No Breath Timeout command.

Flow Control Circuitry

If a pneumatic connection in the ﬂow control circuitry is loose or has failed, transmission of CO2 waveform and breath data packets is halted. Pump operation may be unstable due to the lack of ﬂow control feedback. The Module reverts to fault mode and may respond to status requests by issuing a number of different fault codes.

Pump Inlet

If the pneumatic connection at the pump inlet is loose or has failed, transmission of CO2 waveform and breath data packets is halted. The set ﬂow rate cannot be achieved since the pump is disconnected. The Module reverts to the fault mode and responds to status requests with an <Sxx18> Exhaust Occlusion response.

Page 50 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Section 5 - Pneumatic Operation

Pump Exhaust

If a pneumatic connection at the pump exhaust is loose at either the pump exhaust or internal monitor exhaust port, gas build up within the host monitor can occur. The Module does not report this fault to the host.

WARNING When using oxygen or ﬂammable anesthetics, a pump exhaust leak can

present a ﬁre hazard. It is the responsibility of the OEM to meet regulatory requirements with regard to single fault protection and exhaust tubing.

Refer to Section 6, Regulatory, for additional regulatory and safety information.

Pump Failure

Events resulting from pump failure include:

•low ﬂow

• high ﬂow

• no ﬂow

Low Flow

The pump may fail to meet the set ﬂow rate due to low ﬂow caused by a nonfunctional pump. The Module responds to status requests with a <Sxx18> Exhaust Occlusion Or Pneumatic Leak response.

NOTE The Module remains indeﬁnitely in the total exhaust occlusion state if not commanded

by the host.

High Flow

The pump may fail to meet the set ﬂow rate due to high uncontrollable ﬂow caused by a runaway pump. The Module reverts to the fault mode, turns OFF the pump and responds to status requests with an <Sxx80> Pump Failure response.

No Flow

The pump may fail to meet the set ﬂow rate due to no ﬂow caused by a nonfunctional or electrically disconnected pump. The Module responds to status requests with a <Sxx18> Exhaust Occlusion Or Pneumatic Leak response.

WARNING The Module remains indeﬁnitely in the total exhaust occlusion state if not

commanded by the host.

Welch Allyn OEM Technologies Conﬁdential Page 51

LC101 CO2 Module OEM Implementation Manual

Page 52 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Section 6

Regulatory

IEC 601-1-2 (EN 60601-1-2)

Welch Allyn OEM Technologies

The LC101 Module meets the requirements of IEC 601-1-2 (EN 60601-1-2).

Although sidestream devices do not require patient isolation, the host system must not bridge the isolation barrier with any subcomponents of the LC101 Module. All components with electrical connections to the Main Board must be properly insulated from non-isolated power.

OEM

The responsibilities of the OEM include (but are not limited to) the following:

• The end-use product (the host system) must comply with all appropriate safety requirements of IEC 60601-1 (EN 60601-1) and applicable standards.

• It is recommended that the power supplied to the LC101 Module be fused or provided similar protection in the event of a short circuit.

• Creepage and clearance distances from primary to ground and secondary circuits, as deﬁned in IEC 60601-1 (EN 60601-1), must be maintained after installation to preserve the intended safety.

• Minimum isolation/insulation clearances speciﬁed in IEC 60601-1 (EN 60601-1) when mounting the LC101 Module and all off-board components must be maintained after installation to preserve the intended safety.

• The exhaust tubing must be single fault protected to protect against oxygen buildup in the event of an exhaust tube malfunction.

• The end-user Operator Manual must include instructions for decontaminating, cleaning, and/or safe disposal of sidestream accessories.

Welch Allyn OEM Technologies Conﬁdential Page 53

LC101 CO2 Module OEM Implementation Manual

Electromagnetic Interference

The LC101 Module meets the following EMC requirements without enclosure.

• Radiated Emissions - tested per CISPR 11, 1990

• Magnetic Field Emissions - tested per RE101

Electromagnetic Susceptibility

The LC101 Module meets the following EMC requirements without enclosure.

• Electrostatic Discharge - tested per IEC 1000-4-2, 1995

•Fast Transient Bursts - tested per IEC 1000-4-4 (EN61000-4-4,1995)

• Radiated Electromagnetic Fields - tested per IEC 1000-4-3 with dwell time adjusted to 3 seconds (80 MHz - 1000 MHz)

• Radiated Electromagnetic Fields - tested per IEC 1000-4-3 with dwell time adjusted to 3 seconds (26 MHz - 80 MHz)

• Conducted Electromagnetic Energy - tested per CS114 (MIL-STD-462D)

• Magnetic Fields - RS101 (MIL-STD-462D)

Compliance Testing Summary

The LC101 Module meets the speciﬁcations put forth in the FDA Reviewer Guidance for premarket notiﬁcation submissions of Anesthesiology and Respiratory Devices Branch, November 1993 and IEC 601-1-2, Second Edition, Draft 1, 1996 (EN60601-1-2). The test sample was evaluated in accordance with speciﬁcations put forth in the following.

• CISPR 11, 1990 (EN 55011, 1991)

• IEC 1000-4-2, 1992 (EN 61000-4-2, 1995)

• IEC 1000-4-3, 1995 (ENV 50204)

• IEC 1000-4-4, 1995 (EN 61000-4-4, 1995)

• MIL-STD-461D, 11 January 1993

• RE101, RS101, CS114

ISO 9918 and EN 864

The LC101 Module, when implemented according to this manual, meets or exceeds the requirements outlined in Section 8, Clauses 50.3 through 50.9 and Section 11, Clauses 60 and 61 of the ISO 9918 Standard and equivalent sections of EN 864.

Page 54 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Appendix A

Software Procedures

O2/N2O/Desﬂurane Compensation

The presence of oxygen, nitrous oxide and desﬂurane in the gas sample affects the measurement of the CO method for applying the compensation when these gases are present.

Correction For O

As the N2 in the sample gas is replaced by O2, the effect is a decrease in IR absorption. This results in a lower than actual measured CO present, the raw measurement from the LC101 Module must be increased by a slight factor to

correct for the O via a menu selection or other means.

O2 correction is recommended when the O2 concentration is greater than 50%. At O2 levels equal to or less than 50%, the correction should not be used.

effect. It is recommended that O2 compensation be made available to the user

Correction For N2O & O

To correct for N2O in the sample gas, an assumption is made: if N2O is administered to the patient, then the remaining balance of the administered mixture is O2. The combined effect of these gases is two-fold: O absorption. Though N2O does not directly absorb the ﬁltered IR energy, it causes the CO2 molecule to absorb and pass along some of its energy to the N2O molecule of similar molecular weight. By passing off some of this energy, the CO2 molecule is free to absorb even more energy which leads to an increase in absorption.

concentration. This section describes this effect and recommends a

value (CO2 measured). With the additional O2

presence decreases IR absorption, and N2O presence increases

Since the increased absorption effect due to N2O presence is greater than the decrease due to

presence, an optimal administered mixture of 25% N2O and 75% O2 effectively cancels the

combined effect.

Welch Allyn OEM Technologies Conﬁdential Page 55

LC101 CO2 Module OEM Implementation Manual

Correction For Desﬂurane

The effect of desﬂurane on the CO2 measurement is similar to the effect of N2O. For desﬂurane concentrations above 12%, the N

O correction may be used.

Summary of O2, N2O, and Desﬂurane Compensation

The LC101 Module compensations for O2, N2O and desﬂurane are OFF by default and must be enabled by the host via menu selection or other means. The variables and correction equations

are summarized in this table.

O2 Correction N2O/Desﬂurane Correction Operating Conditions

OFF OFF O2 ≤ 50%, no N2O

ON OFF O2 > 50%, no N2O

OFF ON O2 ≤ 50% and N2O or desﬂurane ≥ 12%

ON ON O2 > 50% and N2O or desﬂurane ≥ 12%

The O2/N2O/desﬂurane compensations are enabled/disabled by the following Function Enable/ Disable commands.

Compensation Function Enable Command

O2 compensation OFF <Q000>

O2 compensation ON <Q001>

N2O compensation OFF <Q010>

N2O compensation ON <Q011>

Desﬂurane compensation OFF <Q020>

Desﬂurane compensation ON <Q021>

Percent CO2 Calculation

It is necessary to convert the CO2 display from mmHg to percent CO2 in order to compare the measurement to a calibrated gas, usually marked in percent CO2. (There are other user environments where the preferred units of measurement is % CO responsible to convert partial pressure (mmHg) CO

to the corresponding percentage. Typically,

calibrated gas measurement is a steady state measurement, so updated breath data is not necessary. Also, calibrated gases are dry gases; therefore the water vapor and BTPS compensations should be disabled by the host in those instances where dry gas readings are made.

.) The host system is

Page 56 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Appendix A - Software Prodedures

1. Initialize breath data update rate <O00>.

2. Request ambient barometric pressure <C22>.

3. Divide ETCO2 (in mmHg) value by ambient barometric pressure (in mmHg). The result is the ETCO

value as a percentage of the barometric pressure.

Zero Calibration Sequence Example

Seq. Host Module Description

1 <Q7F0> Host sends Unprotect command.

<q7F0> Module responds to command from host.

2 <C12> Host sends

<S6325>

<S6X03>

<S6321>

<S6323>

3 <C00> Host polls for completion of sampling.

<S6325>

<S6326>

<S6329>

4 <Q7F1> Host sends Protect command.

<q7F1> Module responds to command from host.

Module responds with status -

if not in unprotected measurement or autorun mode, response is

Operation

if the previous calibration is active, response is or

if the LC101 had been operating for < 5 min., response is

Time

Module responds with status –

step until a response other than <S6325> is returned.

Module responds with status –

if acquiring data does not meet speciﬁcations, response is

Perform Cal., Data Error.

Perform Zero Calibration

Calibration in Progress

(use <Q7F0>), or

Calibration in Progress

Calibration OK

command.

, or

Invalid

Cal. Already in Progress

Cal. Low Run

. Repeat this

Unable to

Welch Allyn OEM Technologies Conﬁdential Page 57

LC101 CO2 Module OEM Implementation Manual

Two-Point User Calibration Sequence Example

NOTE Before performing a Two-Point User Calibration, a separate Zero Calibration must be

performed ﬁrst. It is also recommended that both calibrations be performed at 75ºF in order to maintain accuracy over the Module’s operating temperature range.

Seq Host Module Description

1 <Q7F0> Host sends Unprotect command.

<q7F0> Module responds to command from host

2 <Lmmd-

dyyyy>

3 <Gxx> Host sends span gas value (in percent).

Host sends calibration date.

Module responds with status if date is invalid, response is if not in unprotected measurement or autorun mode, response is

Operation

if previous calibration is active, response is if the LC101 had been operating for < 5 min., response is

Time

Module responds with status if span gas value is invalid, response is if not in unprotected measurement or autorun mode, response is

Operation

if a calibration had not been started, response is if the calibration has exceeded its maximum time allowed, response is

(use <Q7F0>), or

Calibration ready for next step

Invalid Data

Calibration ready for next step

Unable to Perform Cal., Missing Parameters

4 <C10> Host sends

Module responds with status if not in unprotected measurement or autorun mode, response is

Operation

if a calibration had not been started, response is if the calibration has exceeded its maximum time allowed, response is

Sample CO2 Zero Gas

(use <Q7F0>), or

command.

Calibration in Progress

Unable to Perform Cal., Missing Parameters

, or

Cal. Already in Progress

Cal. Low Run

Invalid Data

, or

Cal. Not in Progress

, or

Cal. Not in Progress

, or

Invalid

, or

Invalid

, or

Invalid

, or

5 <C00> Host polls for completion of sampling.

<S6325>

<S6329>

Module responds with status -

step until a response other than <S6325> is returned.

Module responds with status if the calibration has exceeded its maximum time allowed, response is

Unable to Perform Cal., Missing Parameters

if acquiring data does not meet speciﬁcations, response is

Calibration in Progress

. Repeat this

Calibration ready for next step

, or

Unable to

, or

Perform Cal., Data Error.

Page 58 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Appendix A - Software Prodedures

6 <C11> Host sends

7 <C00> Host polls for completion of sampling.

<S6325>

<S6329>

8 <Q7F1> Host sends Protect command.

<q7F1> Module responds to command from host

Module responds with status if not in unprotected measurement or autorun mode, response is

Operation

if a calibration had not been started, response is if the calibration has exceeded its maximum time allowed, response is

Unable to Perform Cal., Missing Parameters

Module responds with status -

step until a response other than <S6325> is returned.

Module responds with status if the calibration has exceeded its maximum time allowed, response is

Unable to Perform Cal., Missing Parameters

if acquiring data does not meet speciﬁcations, response is

Perform Cal., Data Error.

Sample CO2 Span Gas

(use <Q7F0>), or

command.

Calibration in Progress

Calibration OK

, or

Cal. Not in Progress

. Repeat this

, or

Invalid

Unable to

, or

Example of Veriﬁcation Using Dry Gas

Because Module veriﬁcation is typically accomplished using “dry” CO2 gas from a canister, the automatic compensations for water vapor and BTPS must be disabled prior to veriﬁcation. The

host system can temporarily disable these module functions by using the sequence below:

Command from Host Description Note

C00 Requests Module status Verify no faults are reported

Q7F0 Unprotects the Module

Q080 Disables Water Vapor Comp

Q090 Disables BTPS Compensation

O00 Disable Breath Data Packet For continuous CO2 mode

NOTE The Module will revert to the default settings (BTPS and Water Vapor compensations

enabled) when the Module is reset or power cycled. Refer to the Host/Module Communications section ( table. Because the CO2 concentration contained in a canister or cylinder is typically

listed in percent values, it is recommended the host also convert the module’s CO to percent for comparison purposes.

page 25) for more details on the commands listed in the

data

Welch Allyn OEM Technologies Conﬁdential Page 59

LC101 CO2 Module OEM Implementation Manual

CRC

The CRC is performed on the byte stream, not on the corresponding values of the ASCII hex characters. The CRC check should be performed at a very low level within the host's software. The host calculates a CRC of the actual transmitted bytes excluding the check byte (which is sent as two ASCII HEX characters).

For the byte string:

{STX} “W” xx yy CCITT/CRC {ETX} waveform byte string

0x25 0x80 0x79 {STX}W258079{ETX}

02h 57h 32h35h 38h30h 37h39h 03h

057h represents a single character, in this case the ASCII letter "W". 0x25 represents the resulting value of the ASCII HEX representation of the parameter value. Thus, 0x25 is actually transmitted as 32h (ASCII letter "2") followed by 35h (ASCII letter "5").”

CCITT/CRC Code Calculation

The 8-bit CCITT/CRC code is based on the CCITT/CCITT/CRC polynomial which uses the conventional right shifting (high to low) method. The polynomial is:

G(x) = x^8 + x^7 + x^2 + 1

The feedback constant is 0xA1 (hex). CCITT/CRC values are initialized to 0xFF (hex).

The CCITT/CRC update value is implemented by a table look up scheme. The following is an implementation example in ‘C’ language. Usage:

#deﬁne updateCCITT/CRC_8(value,CCITT/CRC) (CCITT/CRC_table_8[value^CCITT/CRC]) #deﬁne MAX_SIZE 23 /*choose any size*/

unsigned char CCITT/CRC_table_8[256]; unsigned char data[MAX_SIZE]; /*data to be CCITT/CRC checked*/

unsigned char calc_CCITT/CRC(char data,int n) {

unsigned char CCITT/CRC; /*make_table_8( );*/ /*do this at least once*/ CCITT/CRC=0xFF; for(i=0;i<n;i++){

CCITT/CRC=updateCCITT/CRC_8(data[i],CCITT/CRC); } return(CCITT/CRC);

}

Page 60 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

The table can be created by the following code:

void make_table_8(void) { const unsigned char feedback_8=0xA1; unsigned char CCITT/CRC;

unsigned int i; unsigned char j,tmp; for (i=0; i<256;i++){

tmp=i

CCITT/CRC=0;

for (j=0; j<8;j++){

if ((tmp&1)^(CCITT/CRC&1))

CCITT/CRC=(CCITT/CRC>>1)^feedback_8;

else CCITT/CRC>>1;

tmp>>=1; } CCITT/CRC_table_8[i]=CCITT/CRC;

}

Appendix A - Software Prodedures

Software Upgrade

The LC101 Module's software may be updated in the ﬁeld through the Module's serial link into the processor's FLASH memory. The host system is responsible for providing access to the Module’s serial link either by allowing pass through to the Module from the host main control board, or by allowing external access to the Module serial link within the host system.

Control of the software transfer is handled by the boot block of the Module's processor. If transfer of a new program is disrupted during a download, it may be restarted to overwrite any corrupted data.

Welch Allyn OEM Technologies will provide a software load application when software upgrades are required. To load new executive code into the Module via the serial port of a PC or laptop, you will use the download application provided by Welch Allyn OEM Technologies.

Welch Allyn OEM Technologies Conﬁdential Page 61

LC101 CO2 Module OEM Implementation Manual

Page 62 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Appendix B

EEPROM Memory Map

System EEPROM Map Table

Word (hex) Register Description

00 16 bit CCITT/CRC word/range: 01h to 2Ah

01 LSB

MSB

02 Main Board serial # / range: 0000h to FFFFh

03 LSB

MSB

10 LSB

MSB

11 LSB Desﬂurane compensation

12 LSB

MSB

14 LSB & MSB Sidestream baseline compensation

19 Startup ﬂags-

1A LSB

MSB

25 Baud rate setup

3F 16 bit CRC of words 2Bh to 3Eh

Low nibble- EEPROM minor revision High nibble- EEPROM major revision Customer code.

Hardware version Reserved for future use.

O2 compensation

N2O compensation

Reserved for future use Water compensation

bit 0- set, reserved for future use bit 1- set, selects Auto start up operation bit 2- set, selects FAULT mode on start up (overrides bit 1) bits 3-5- set to 0, reserved for future use bit 6- set to 1, selects serial word length (0=8 bits, 1= 7 bits) bits 7- 15- set to 0, reserved for future use

Breath update rate Reserved for future use

(Welch Allyn OEM Technologies internal use)

Welch Allyn OEM Technologies Conﬁdential Page 63

LC101 CO2 Module OEM Implementation Manual

Page 64 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Appendix C

Error Messages & Recovery

This appendix lists and deﬁnes the LC101 Module status codes. Recovery attempts are suggested if the status indicates a fault condition. The fault conditions are grouped into three categories.

• Advisories - Non-fatal conditions which do not halt Module operation.

• Soft faults - Conditions which interrupt Module operation, including transmission of CO

waveform and breath data packets, until the fault is cleared. The Module can

accept commands while in the soft fault state.

• Hard faults - Halt Module operation and prevent the Module from accepting commands. The software reset command (<C80>), or a host reset, can be used to clear hard faults.

Recovery attempts may include the host initiating one of these external resets:

• Software Reset - The host may command a software reset using the <C80> command while the Module is unprotected. After the reset, the Module returns to its EEPROM default settings.

Welch Allyn OEM Technologies Conﬁdential Page 65

Advisories

LC101 Advisories

LC101 CO2 Module OEM Implementation Manual

Status

Deﬁnition Possible Causes Message Code (hex)

00 status ok

01 communication error • host/Module communication is in error

02 host command with invalid data • identiﬁer is inconsistent with data

03 unprotected operation violation • host attempts to invoke a protected operation

06 acknowledge command

11 CO2 sensor startup in progress • status requested during CO2 sensor startup

phase

27 calculation error • calculated CO2 value is out of range

27, Calculation Error

The Module detected an error when calculating the CO2 measurement. This message is available in all modes. The error is generated when the calculated CO

value is over 99 mmHg.

Pneumatic System Advisories

Status Message Code (hex)

Deﬁnition Possible Causes

15 vacuum offset too

large

16 no watertrap •watertrap not properly installed

17 watertrap or cannula

occlusion

18 exhaust occlusion or

pneumatic leak

• input connected to an external vacuum source

•faulty receptacle/watertrap receiver switch

• misaligned watertrap receiver switch

•faulty receptacle/watertrap receiver switch

• obstructed watertrap/cannula

• sample line kink

• obstructed internal pneumatic component

• obstructed exhaust port

•exhaust tubing kink

•faulty/disconnected pump

Page 66 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Appendix C - Error Messages & Recovery

15, Vacuum Offset Too Large

The Module detects a vacuum condition prior to the pump turning on. Transmission of CO2 waveform and breath data packets will not begin. The pump is disabled during this advisory. This

message could also indicate that one or both transducers are faulty.

•Verify that no external vacuum is applied to the monitor’s CO2 inlet port.

16, No Watertrap

The Module does not detect a watertrap properly inserted into the watertrap receiver. Tr ansmission of CO

waveform and breath data packets is halted unless the watertrap is

temporarily disconnected. If reinsertion occurs within 30 seconds from disconnect, the Module resumes normal operation. If not connected within 30 seconds, the Module reverts to standby mode and halts the transmission of data packets. When the advisory is cleared, a new measurement mode command is required to resume data packet transmission unless the Module was in the auto run mode. In this case, measurement resumes. The sidestream pump is disabled during this advisory.

• Reinsert the watertrap into the watertrap receiver.

• Check for a misaligned or faulty watertrap receiver switch.

17, Watertrap or Cannula Occlusion

Low ﬂow and high vacuum conditions are detected in the pneumatic system. CO2 waveform and breath data packets are available despite the advisory. The Module attempts to clear obstructions

while reporting these conditions by increasing the pump speed. If the obstruction is not cleared after 5 seconds, the Module decreases the pump speed and holds vacuum for an additional 15 minutes. If the obstruction is not cleared after 15 minutes, the Module reverts to standby mode.

• Clear any obstructions in the watertrap and cannula.

• Straighten any kinks in the cannula tubing.

•Brieﬂy disconnect the cannula from the watertrap. If the cannula is the fault source, the fault is corrected.

• Replace the watertrap and/or cannula.

• Refer to Section 5, Pneumatic Operation, for additional information.

18, Exhaust Occlusion or Pneumatic Leak

Low ﬂow and normal vacuum conditions are detected in the pneumatic system. CO2 waveform and measurement data packets are available despite the advisory. Normal measurement resumes after the advisory is cleared.

NOTE When this condition occurs, the Module increases pump speed to a maximum and runs

indeﬁnitely until the condition is cleared.

• Clear any obstructions in the exhaust tubing and screen.

• Straighten any kinks in the exhaust tubing.

Welch Allyn OEM Technologies Conﬁdential Page 67

LC101 CO2 Module OEM Implementation Manual

• Verify that the pump is operating by resetting the mode and listening for audible pump operation noise.

• Refer to Section 5, Pneumatic Operation, for additional information.

Calibration Advisories

Calibration advisories interrupt the calibration operation until the condition is cleared. The calibration sequence continues after the condition is addressed by the host/user. Calibration advisory messages include 21 through 26.

Calibration advisories are listed in the following table.

Status

Deﬁnition Possible Causes Message Code (hex)

21 calibration already in

progress

22 calibration not in progress • Module receiving calibration commands before

23 low run time • Module has not met run time requirement of 5

24 calibration ready for next

step

25 calibration in progress •valid Module calibration procedure initiated by

26 calibration ok • Module calibration successfully completed and

• calibration command received from host while Module calibration sequence already in progress

calibration sequence properly initiated by host

minutes

• Module ready to accept host data to proceed with calibration

host; Module presently sampling.

new constants stored in EEPROM

21, Calibration Already in Progress

The Module has received a command to initiate a new calibration sequence while the Module is already running calibration.

22, Calibration Not in Progress

The Module is receiving calibration data commands from the host before the calibration sequence is properly initiated.

23, Low Run Time

The Module has not been running in measurement mode or autorun mode for 5 minutes prior to receiving the calibration command from the host.

NOTE Removing the watertrap during a calibration sequence causes the calibration procedure

to abort and resets the 5-minute run time clock. Module operation during calibration differs from normal autorun or measurement mode operation.

Page 68 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Appendix C - Error Messages & Recovery

24, Calibration Ready for Next Step

The calibration sequence has been initiated, and the Module requires data commands from the host to proceed to the next calibration step.

25, Calibration in Progress

The Module is carrying out the calibration process.

26, Calibration OK

The Module has successfully performed a calibration, and the new constants have been stored in the EEPROM. After successful User Calibration, the Last Calibration Date is also updated to reﬂect the new information.

Soft Faults

Soft faults are conditions which halt Module operation, including transmission of CO2 waveform and breath data packets, until the condition is cleared. The Module can accept commands while

in the soft fault state.

Calibration Faults

Calibration faults abort calibrations. The Module requires a new calibration command to reinitiate the calibration sequence after the error is cleared. Calibration fault messages include 28 through 2A. To clear a calibration fault, send a new host command. If the Module does not accept the command, a software reset may be required.

Calibration faults are listed in the following table.

Status Message Code (hex)

28 unable to perform

29 unable to perform

2A bad calibration crc • error in system EEPROM

Deﬁnition Possible Causes

• calibration sequence must be completed within 30

calibration, parameters missing

calibration, data error

minutes

• acquired CO2 data is invalid for calibration sequence; error also provided if calibration is

aborted due to another error

28, Unable to Perform Calibration, Parameters Missing

The Module timed out while waiting for a data command from the host during the calibration sequence. The calibration sequence must be completed within 30 minutes of initiation.

Welch Allyn OEM Technologies Conﬁdential Page 69

LC101 CO2 Module OEM Implementation Manual

29, Unable to Perform Calibration, Data Error

The acquired CO2 data is invalid or out of range for the calibration. The Module will abort the calibration. This error also occurs when calibration is aborted due to any other non-fatal error.

2A, Bad Calibration CRC

The system EEPROM CRC is not valid after being updated with the new constants.

Sensor Faults

CO2 sensor faults are conditions that result in shutting down the sensor. A CO2 sensor shutdown turns off the lamp and the pump.

To clear a sensor fault, perform a software reset followed by a new host command.

If the Module

does not accept the command, a hard reset is required.

Sensor faults are listed in the following table.

Status

Deﬁnition Possible Causes Message Code (hex)

51 Customer code mismatch • Incorrect EEPROM data or bad sensor EEPROM

57 CO2 sensor not found • Main Board not acknowledging the sensor

• loose or faulty sensor connection

60 CO2 sensor EEPROM error

in revision #

65 CO2 sensor EEPROM error

in read or write operation

66 CO2 sensor EEPROM error

in CCITT/CRC code

70 CO2 sensor temperature

too high

• incompatible/invalid sensor EEPROM revision #

•faulty sensor EEPROM

•invalid read/write to sensor EEPROM;

•faulty sensor EEPROM

•invalid sensor EEPROM CCITT/CRC code;

•faulty sensor EEPROM

• sensor exposure to excessive heat source;

•faulty sensor

71 CO2 sensor temperature

too low

• sensor exposure to excessive cold source;

•faulty sensor

51, CO2 Sensor Manufacturer Code Mismatch

Sensor manufacturer code stored in sensor EEPROM does not match the host monitor manufacturer code.

•Verify the data in the EEPROM location.

Page 70 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

57, CO2 Sensor Not Found

CO2 Bench, or C-Cap, not present on Main Board.

60, CO2 Sensor EEPROM Error/Revision #

Revision # read from the CO2 sensor EEPROM is not in the 1.xx format.

65, CO2 Sensor EEPROM Error/Read/Write

A read or write error to the CO2 sensor EEPROM has occurred.

66, CO2 Sensor EEPROM Error/CCITT/CRC Code

CCITT/CRC code read from the CO2 sensor EEPROM is invalid.

70, CO2 Sensor Temperature Too High

The CO2 sensor’s temperature is greater than 60oC for more than 30 seconds.

Appendix C - Error Messages & Recovery

• Check for the presence of an external excessive heat source that is in close proximity to the Module. Remove the source or relocate the Module.

71, CO2 Sensor Temperature Too Low

The CO2 sensor’s temperature is less than 5oC for more than 30 seconds.

• Check for excessive cold ambient conditions or the presence of an external cold source that is in close proximity to the Module. Remove the source or relocate the Module.

Welch Allyn OEM Technologies Conﬁdential Page 71

LC101 CO2 Module OEM Implementation Manual

System Faults

The majority of system faults are conditions that are internal to the Module and not caused by the host. The exceptions are 81h, 82h, 84h and 85h.

To clear most system faults:

• Do a reset (with the exception of 81, 82, 84 and 85).

System faults are listed in the following table:

Status Message

Deﬁnition Possible Causes

Code (hex)

40 watchdog error •watchdog timeout

44 system EEPROM error

in CCITT/CRC code

46 system FLASH ROM

error in CCITT/CRC code

47 system communication

error

4B system external RAM

error

4C system internal RAM

error

4D system FLASH ROM

error in checksum

4E stack overﬂow error • stack usage error

4F system main program

exited

•invalid system EEPROM CCITT/CRC code

•invalid FLASH ROM CCITT/CRC code

•faulty FLASH ROM chip

• microprocessor failure to complete task

• malfunctioning real-time operating system

•faulty system external RAM

•faulty system internal RAM

•invalid system internal FLASH data

•faulty FLASH ROM chip

• executive failure

80 pump failure •faulty pump;

• pneumatics disconnected

81 unexpected reverse ﬂow •watertrap/cannula/exhaust tubing not properly con-

nected

82 unexpected forward ﬂow •watertrap/cannula/exhaust tubing not properly con-

nected

84 barometric pressure too

high

85 barometric pressure too

low

• host system operating above 824 mmHg (1,150 ft below sea level)

•faulty barometric transducer

• host system operating below 408 mmHg (15,000 ft above sea level)

•faulty barometric transducer

Page 72 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

40, Watchdog Error

Watchdog timeout has occurred.

44, System EEPROM Error/CCITT/CRC Code

CCITT/CRC code read from the system EEPROM is invalid.

46, System FLASH ROM Error/CCITT/CRC Code

CCITT/CRC code read from the system FLASH ROM is invalid.

47, System Communication Error

4B, System External RAM Error

4C, System Internal RAM Error

4D, System FLASH ROM Error/Checksum

Checksum read from the system FLASH ROM is invalid.

Appendix C - Error Messages & Recovery

4E, Stack Overﬂow Error

An error in stack usage occurred.

4F, System SW Error/Main Program

Main SW program is exited.

80, Pump Fault

High ﬂow and high vacuum conditions are detected in the pneumatics.

Refer to Section 5, Pneumatic Operation, for information about this fault.

81, Unexpected Reverse Flow

An unexpected reverse ﬂow condition in the pneumatics, indicated by non-zero initial values, turns the pump off.

• Check the watertrap and cannula for an improper connection to a vacuum source.

• Check the exhaust tubing for an improper connection to a positive pressure source.

• Refer to Section 5, Pneumatic Operation, for additional information.

82, Unexpected Forward Flow

An unexpected forward ﬂow condition in the pneumatics, indicated by non-zero initial values, turns the pump off.

• Check the watertrap and cannula for an improper connection to a positive pressure source.

Welch Allyn OEM Technologies Conﬁdential Page 73

LC101 CO2 Module OEM Implementation Manual

• Check the exhaust tubing for an improper connection to a vacuum source.

• Refer to Section 5, Pneumatic Operation, for additional information.

84, Barometric Pressure Too High

Barometric pressure transducer reading is greater than the upper barometric limit.

• Check that the host monitor is operating at barometric pressures less than 824 mmHg (1,300 ft below sea level).

•Possible transducer error.

85, Barometric Pressure Too Low

Barometric pressure transducer reading is less than the lower barometric limit.

• Check that the host monitor is operating at barometric pressures greater than 408 mmHg (15,500 ft above sea level).

•Possible transducer error.

Page 74 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Appendix D

Welch Allyn OEM Technologies Part Numbers and Accessories

Module Conﬁgurations

Module Conﬁguration Description Welch Allyn OEM Technologies

LC101 Module (generic) 000.10100

Watertrap Receiver, gray, 2.385 in, with Switch Assembly 002.00086

Watertrap Receiver, black, 2.385 in, with Switch Assembly 002.00164

Watertrap Receiver, gray, 1.615 in, with Switch Assembly 002.00091

Pump Assembly (with wire harness) 002.00150

Inlet Tubing (Inside Diameter, Outside Diameter, Type) OEM-speciﬁc

Exhaust Tubing (Inside Diameter, Outside Diameter, Type) OEM-speciﬁc

Mufﬂer, exhaust 411.00012

Fitting, Luer, female, 0.06 411.00010

Shut off pellet, in-line 002.00077

Part Number

Welch Allyn OEM Technologies Conﬁdential Page 75

LC101 CO2 Module OEM Implementation Manual

Accessories Available From Welch Allyn OEM Technologies

NOTE: The following accessories are recommended for use with the LC101 Module and may be

ordered from Welch Allyn OEM Technologies. The end user must be instructed in the end-user documentation such as the Operator’s Manual to follow the accessory manufacturer’s directions for use when using any accessories.

Accessory Description Welch Allyn OEM Technologies

Part Number

Watertrap - box of 24 000.91160

Watertrap - box of 10 000.91150

CO2 Scrubber - box of 5 000.91155

Adult CO2/O2 Nasal Cannula - box of 25 000.91130

Pediatric CO2/O2 Nasal Cannula - box of 25 000.91120

Infant CO2/O2 Nasal Cannula - box of 25 000.91280

Adult CO2 Nasal Cannula - box of 25 000.91131

Pediatric CO2 Nasal Cannula - box of 25 000.91132

Infant CO2 Nasal Cannula - box of 25 000.91133

Adult CO2 Oral/Nasal Cannula -box of 25 000.91134

Pediatric CO2 Oral/Nasal Cannula - box of 25 000.91135

Sample Line/ 7 ft - box of 25 000.91390

LC101 CO2 Module - OEM Implementation Manual 000.91161

Page 76 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Appendix E

Speciﬁcations

LC101 Main Board

PHYSICAL SPECIFICATIONS

Size 3.15 in. x 3.90 in. (80.3 mm x 99.3 mm)

Clearance 0.85 in. (22 mm) above board, 0.12 in (3 mm) below board

Orientation No limitations

Weight Less than 1 pound (454 grams) with full pneumatics.

SYSTEM PERFORMANCE SPECIFICATIONS

Sampling Method Built-in sidestream sensor

Patient Application Neonatal to adult

CO2 Concentration Display Range 0 - 99 mmHg

Respiration Rate Range 1 - 99 breaths per minute

Typical CO2 Accuracy

Start-Up Time Less than 10 seconds to acquire CO2 waveform data

Calibration Zero Calibration and Two-Point User Calibration

C-Cap Rise Time Less than 200 msec (10% - 90%, bench only)

Less than 3 minutes to full operating speciﬁcation.

Flow Rate Range User-selectable, variable from 90 to 200 ml/min (defaults to 175

ml/min)

Flow Rate Accuracy -20/+15% of set value.

Welch Allyn OEM Technologies Conﬁdential Page 77

LC101 CO2 Module OEM Implementation Manual

ENVIRONMENTAL SPECIFICATIONS

Ambient Operating Range

Temperature Humidity Barometric Pressure Pressure Compensation

Ambient Shipping/Storage Range

Temperature Humidity Barometric Pressure

5o to 55oC (50o to 131oF) 15% to 95% RH (non-condensing) 420 to 795 mmHg (15,500 feet to -1300 feet) Automatic at power on and watertrap replacement

-40o to 70oC (-40o to 158oF) 10% to 100% RH (non-condensing) 375 to 795 mmHg (45,000 feet to -1300 feet)

INTERFACE SPECIFICATIONS

Input Power +5 V regulated, or +5.75 to 14.5 V unregulated

Maximum Ripple Voltage 100 mV peak-to-peak

Power Consumption 570 mW (Typical non-measurement power at 8 V)

1.3 W (Typical measurement mode power at 8 V)

1.5 W (Typical occluded power at 8 V)

Communication Asynchronous serial

Data format is either 7E1 or 8E1 (conﬁgurable option) 9600 Baud Full Duplex

Software Upgrades Serial Port (download to FLASH memory)

BTPS Compensation Ye s, user-controlled

N2O, O2, and Desﬂurane Compensation

Ye s, user-controlled

a.Typical CO2 accuracy is based on the following:

Ambient temperature 22oC Standard gas mixture of CO2 in balance air

Barometric pressure at 760 mmHg (sea level) CO2 sample line 7 foot, I.D. 0.055” (1.4 mm)

Welch Allyn OEM Technologies Watertrap (P/N 002.70860) and Watertrap Receiver (P/N 112.00039) Sampling ﬂow rate 175 ml/min Respiratory rate < 30 BPM, stable to ±3 BPM I:E ratio = 1:2

Note: CO2 accuracy is derated between 5o to 15oC and 45o to 55oC: +/- 4 mmHg0-40 mmHg

+/- 10% of reading41-76 mmHg +/- 12% of reading77-99 mmHg

CO2 accuracy is also affected at high breath rates, i.e. >50 BPM, I:E ratio = 1:1.

Page 78 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Assembly Drawings

(Ref. 000.10100.UOO Rev. 0)

LC101 Module - ISO View

Appendix E - Speciﬁcations

Pump exhaust

Inlet

(Ref. 000.10100.UOO Rev. 0)

LC101 Module - Side View

LC101 Module - Top View

Welch Allyn OEM Technologies Conﬁdential Page 79

LC101 CO2 Module OEM Implementation Manual

Receiver switch wires

Watertrap Receiver Assembly

Watertrap

CO2 Absorber

Watertrap and CO2 Absorber

Page 80 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Appendix E - Speciﬁcations

CO2 Absorber Material Safety Data Sheet (MSDS)

Welch Allyn OEM Technologies Conﬁdential Page 81

LC101 CO2 Module OEM Implementation Manual

Page 82 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Appendix F

CO2 Developer’s Kit

Introduction

The CO2 Developer’s Kit provides hardware and software to simulate a monitoring system capable of measuring and displaying real-time carbon dioxide measured in a patient’s exhaled

breath. The system also displays breath parameters such as end-tidal CO2, inspired CO2, and respiration rate. The following items make up the CO2 Developer’s Kit:

•CO2 Module (LC-101)

• CO2 Module Evaluation Platform

•Evaluation Platform Power Supply

• Serial Cable (9pin D-Type)

•CO2 Monitor Windows Software (CD) operating on a PC with these minimum requirements: 200 MHz Pentium, 32MB of RAM, 10MB of hard drive space.

NOTE Several different versions of the CO2 Developer’s Kit are available depending on the

customer requirements. Contact Welch Allyn OEM Technologies for more information.

Disclaimer

The CO2 Evaluation System does not have regulatory approval and is not intended for clinical use. It is only intended as an engineering evaluation tool.

Welch Allyn OEM Technologies Conﬁdential Page 83

LC101 CO2 Module OEM Implementation Manual

Software Installation

To install this software on a Windows 95/98/NT computer, do the following:

1. Insert the CO2 Monitor Windows Software CD into the computer’s CD-ROM drive.

2. Follow the screen instructions to install the software.

If the CO2 Monitor software setup program does not start automatically, follow these steps:

Open My Computer, Windows Explorer, or File Manager.

Double click on the CD drive letter (usually D:,E:, or F:).

Double click Setup.exe.

Follow the screen instructions to install the software.

Initial Setup

To connect the hardware and start the program:

1. Plug the Serial Cable’s male connector into the 9 pin D-Type Serial jack on the back panel of the CO

2. Plug the Serial Cable’s female connector into the Computer’s Serial Port 1 (CommPort 1).

3. With the Power Supply’s AC cord unplugged, connect the Power Supply’s other plug into the power jack on the back of the CO

4. Plug the Power Supply’s AC cord into a 110 VAC wall outlet (or 220 VAC depending on transformer conﬁguration and available AC power).

5. At the computer, locate the CO2Mon Program directory created during the installation process, and click on the CO2Mon icon to start the program.

Module Evaluation Platform.

Page 84 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Overview

Appendix F - CO2 Developer’s Kit

Main Screen Illustration

Located on the Main Screen are the real-time CO2 waveform graph and the Breath Parameters. The CO

data can be reported as partial pressure (mmHg) as shown in the illustration or in

percent units (see Menu Options Description below). The Breath Rate is reported in breaths per minute.

The update rate of the CO2 waveform and the Breath Parameters depends on how the CO2 module is conﬁgured. The CO2 module supplied with the evaluation kit is conﬁgured with the default CO The CO

waveform rate of 30mSec and a default Breath Parameter rate of once per breath.

waveform’s sweep rate can be changed in the Conﬁgure menu. The sweep rate units

listed in the menu selection assume the 30mSec waveform rate.

A standard drop-down style Windows Menu Bar is available across the top of the Main Screen. The function of each item available on the menu bar is described below. Along the bottom of the screen is a “Freeze” button that (when clicked on) freezes the CO

waveform and Breath

Parameters. The “Freeze” button (when clicked on) changes to a “Resume” button, allowing you to resume normal monitoring.

The Main Screen can be resized in both directions by moving the mouse pointer to the edge of the window and dragging (left click and hold while moving the mouse). The CO

module’s status

is displayed at the bottom of the screen along with the PC’s conﬁgured serial port settings.

Welch Allyn OEM Technologies Conﬁdential Page 85

Menu Options Description

The File menu contains the following items:

LC101 CO2 Module OEM Implementation Manual

CalibrationFile

Capture

Simulate

Print Form

Exit

Zero

Tw o Point

Configure

Enable

Setup

File\Calibration (LC-101 Module only) - Calibration is available under the File menu. Two different calibrations are available; Zero and Two Point. The Zero calibration is a single point calibration performed with either room air or reference air with 0% CO

. The Two Point

calibration requires a zero reference gas and a span reference gas. The zero can again be room air or 0% reference gas. The span reference gas must have a CO2 concentration of between 8%

and 12%, with the exact concentration known to within 0.1%. The span gas concentration must be manually entered in the Conﬁgure menu item.

File\Capture - The Capture feature provide a means of logging CO2 data and Breath Parameters to a ﬁle. Select the Capture Setup menu item to specify the ﬁle name, data logging rate and what

data is to be logged. The data is stored as ASCII text in a CSV format in the application directory.

File\Simulate - The Simulate feature disables any communications to the CO2 module and displays a simulated CO2 waveform and Breath Parameters. Clicking on this menu item enables and disables the simulation feature.

File\Print Form - The Print Form selection prints the Main Screen to the default printer.

File\Exit - The Exit selection stops the program.

Page 86 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Appendix F - CO2 Developer’s Kit

The Conﬁguration menu provides a means to setup up how the CO2 Monitor functions. The conﬁguration items are saved and restored at start up of the CO

Monitor application. The

Conﬁguration menu contains the following items:

Configure

Mode

Display

CO2 Module

Mainstream

Sidestream

Units

Sweep Rates

CO2 Scale

Gridlines

Waveform Fill

Flow Rate

mmHg

Percent

6.25 mm/sec

12.5 mm/sec 25 mm/sec

50 mmHg

75 mmHg

100 mmHg

90 ml/min 150 ml/min

175 ml/min

10%

14%

CommPort

Conﬁgure\ Mode\ Mainstream (Duet module only) - Checking this enables mainstream operation and disables sidestream operation.

Conﬁgure\ Mode\ Sidestream (Duet module only) - Checking this enables sidestream operation and disables mainstream operation.

Conﬁgure\ Display\Units - The CO2 Monitor will display CO2 values in either partial pressure (mmHg) or percent. These units apply to the waveform and the EtCO

and InsCO2 values.

Conﬁgure\ Display\Sweep Rate - The sweep rate setting determines the sweep rate of the CO2 waveform. This actual sweep rate may vary depending on the PC’s conﬁgured display resolution.

Welch Allyn OEM Technologies Conﬁdential Page 87

LC101 CO2 Module OEM Implementation Manual

Conﬁgure\ Display\CO2 Scale - The CO2 waveform scale can be changed in the Conﬁgure\Display\CO2 Scale menu item. The selections are listed below.

50 mmHg 6%

75 mmHg 10%

100 mmHg 14%

Conﬁgure\ Display\Gridlines - Horizontal gridlines on the waveform graph can be enabled by checking the Gridlines menu item.

Conﬁgure\ Display\Waveform Fill - The Waveform Fill feature can be enabled by checking the Waveform Fill menu item.

Conﬁgure\CO2 Module\Flow Rate - The CO2 Module’s aspiration rate can be conﬁgured with the Flow Rate menu item. The units are in milliliters per minute.

Conﬁgure\CO2 Module\CommPort - This menu item opens the following communications port conﬁguration screen.

NOTE The CO2 Module supplied with the Evaluation System will be pre conﬁgured to match the PC

software’s default settings (Data Bits and Baud Rate), which are shown above. The CommPort Assignment must be set to match the PC’s CommPort connected to the CO2 Module during

initial setup.

The Help\About menu item displays the software title and version, copyright and a disclaimer.

The Help\Content menu item displays help information.

Page 88 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

CO2 Evaluation Platform

Appendix F - CO2 Developer’s Kit

NOTE Backside (not shown) provides connectors for DC power input and RS-232 interface.

CO2 Evaluation Platform

Welch Allyn OEM Technologies Conﬁdential Page 89

LC101 CO2 Module OEM Implementation Manual

Page 90 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Glossary

Absolute Pressure Transducer - A device that converts a nonelectrical parameter, pressure,

into an electrical signal. The ambient pressure transducer on the Module is used to measure either ambient barometric pressure or the internal bench pressure during pump operation.

Advisory - Least serious type of fault message. Usually indicates casual user intervention

required.

ASCII - American Standard Code for Information Interchange

ATPD - Ambient Temperature and Pressure, Dry Gas. Describes the gas conditions when the

measurement was taken.

Auto Run Mode - One of three Module operating modes. Autorun allows the Module to operate

with minimal user or host intervention. In autorun mode, the Module does not revert to standby mode during a watertrap removal.

Background CO2 - Level of carbon dioxide present in the environment in which a CO2

measurement is taken.

Balance Air - The remainder in a speciﬁc concentration of mixed gases.

Barometric Pressure - The pressure caused by atmospheric conditions.

Baseline Compensation - A mathematical correction used to account for the effect of low level

gas mixing during inspiration.

Bench - See Capnography Bench.

bpm - breaths per minute

Breath Data - The breath rate results, derived from the breath algorithm, supplied by the Module

to the host system in packet form.

Welch Allyn OEM Technologies Conﬁdential Page 91

LC101 CO2 Module OEM Implementation Manual

BTPS - Body Temperature, ambient Pressure, gas Saturated with water vapor. Describes the

conditions in which a gas measurement was taken.

BTPS Compensation - Mathematical correction for the environmental differences between the

measurement site (i.e. the measurement bench) and “deep lung” CO

Cannula - A device, or tubing, used to deliver oxygen to a patient orally or nasally. Some types

are divided to deliver oxygen through one tube, and aspirate CO

through another

tube.

Capnogram - a graphical display of carbon dioxide concentration over time.

Capnography Bench - Another name for the CO2 sensor, the device that detects and measures

the level of carbon dioxide in a gas sample.

CCap - Welch Allyn OEM Technologies’s Capnography Bench for the LC101 Module.

CCITT/CRC Code - The program code used to derive a cyclical redundancy checksum table

used to verify error-free data transmission.

CISPR 11 - Limits and Methods of Measurement of Electromagnetic Disturbance Characteristics

of Industrial, Scientiﬁc and Medical (ISM) Radio Frequency Equipment (Class B).

CO2 - Carbon dioxide, a byproduct of cellular metabolism; the majority of which is eliminated by

the lungs.

CO2 Sensor - The device used to detect and measure the level of carbon dioxide concentration

in a gas sample.

CO2 Waveform - The graphical representation of carbon dioxide concentration over time.

Conﬁguration Command - Communication protocol command used by the host system to

temporarily modify speciﬁc Module settings for measurement criteria. The commands usually include speciﬁc data within the command structure.

Conﬁguration Response - The Module’s reply to a conﬁguration command from the host

system. It also represents the Module’s receipt of the command.

CRC - Cyclic Redundancy Check- An error-detecting code generated from a polynomial that can

be added to a data record or message.

CS114 - Conductive Electromagnetic Energy Test Standard (MIL-STD-461D).

DCOM - Welch Allyn OEM Technologies’ DOS-based communication software for the LC101

Module.

Desﬂurane - Anesthetic gas that affects infrared light absorption.

Page 92 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Glossary

Desﬂurane Compensation - Mathematical correction applied to the CO2 measurement to

account for the effects of Desﬂurane on the CO2 concentration.

Differential Pressure Transducer - An electronic device that converts a nonelectrical parameter

into an electrical signal. A differential transducer has two inputs and produces an output signal that is a function of the difference between the inputs. It is used together with a ﬁxed resistance across the inputs to measure gas ﬂow.

EEPROM - Electrically Eraseable Programable Read Only Memory.

EN864 - Standard for Capnometers for use with humans.

ETCO2 - End-Tidal CO2; the measured carbon dioxide value at the end of an exhaled breath.

ETCO2 Monitor - A device that provides a numeric and/or graphical display of the end-tidal CO2

value. Monitors typically include alarm parameters.

ETCO2 Waveform - A graphical display of end-tidal CO2.

Exhaust Occlusion - Obstruction of the exhaust port or tubing downstream from the pump.

Fault State - A state in which the Module detects an internal operating error.

Flash - A type of EEPROM that can be reprogrammed in-circuit.

Forward Flow - A condition that causes a positive pressure on the Module’s input pneumatics or

inlet port before the Module’s pump is activated.

Gas Canister - Typically a pressurized cylinder containing a known concentration of a speciﬁc

gas.

Hard Fault - Condition that halts Module operation and prevents the Module from accepting

commands. The software reset command (<C80>), or a host reset, can be used to clear a hard fault.

Hard Reset - Reset caused when the host holds the receive data line in a break condition for

more than 500 msec. The microprocessor is forced to enter the boot mode when the break condition is released. The microprocessor boot mode is used to install new software into the FLASH device.

HCV - High Clearing Vacuum.

Host System - The main system that controls the LC101 Module within a device.

IEC - International Electrotechnical Commission.

IEC 601-1 - Medical electrical equipment part 1: General Requirements for Safety.

Welch Allyn OEM Technologies Conﬁdential Page 93

LC101 CO2 Module OEM Implementation Manual

IEC 801-1 - The electromagnetic compatibility for Industrial Process and Measurement and

Control Equipment.

IEC 1000 - Electromagnetic Compatibility Testing and Measurement Techniques.

Infrared Radiation (IR) - The portion of the electromagnetic spectrum of radiation extending

from about 730 nanometers to about one millimeter in wavelength.

Inlet Occlusion - Obstruction of the inlet port or pneumatics upstream from the sample

chamber.

InsCO2 - Inspiratory CO2; the level of CO2 present during the inspiratory cycle of a breath.

Intubation - The insertion of a tube into the trachea.

IR Detector - A device used to detect the presence of infrared radiation.

IR Source - A device used to radiate frequencies in the IR region of the electromagnetic

spectrum.

ISO - The International Organization for Standardization.

ISO 9918 - The speciﬁc ISO standard for Capnometers for use with Humans.

LCV - Low Clearing Vacuum.

Long Watertrap Receiver - A Welch Allyn OEM Technologies accessory that mechanically

interfaces the Welch Allyn OEM Technologies watertrap with the host system. The long receiver positions into the host system leaving a small part of the watertrap exposed externally. See Short Watertrap Receiver.

Mainstream Sampling - CO2 analysis whereby the sample chamber is in-line between the

patient airway and the ventilator circuit.

Measurement Mode - One of three Module operating modes. Measurement mode requires

some host intervention for the Module to operate under certain conditions. While the watertrap is removed, the sensor’s activity is halted and the Module reverts to the standby mode.

MIL-STD-461D - Environmental Test Methods Standards.

mmHg - millimeters of mercury.

Mode Command - A command sent by the host to put the Module into one of three operating

modes.

N2O - Nitrous Oxide. Anesthetic gas that affects infrared light absorption

Page 94 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Glossary

N2O Compensation - Mathematical correction applied to the CO2 measurement to account for

the effects of Nitrous Oxide on the CO

concentration.

O2 - Oxygen.

O2 Compensation - Mathematical correction applied to the CO2 measurement to account for the

effects of oxygen on the CO

concentration.

Pressure Broadening Compensation - Mathematical correction applied during CO2 calculation

to account for the effect that barometric pressure has on CO2 molecule distribution.

Pump - The device used by the Module to aspirate the CO2 sample from the patient.

RE101 - Magnetic Field Emisions Test Standard (MIL-STD-462D).

Reset - A Module event caused when the receive data line is held in a break condition for

between 10 and 500 msec. After the reset, the Module returns to its EEPROM default settings and starts up in the standby mode. The Module can respond to host communication 2 seconds after a reset.

Reverse Flow - A condition that causes a positive pressure on the Module’s exhaust pneumatics

or CO

outlet port, where the ﬂow direction is opposite of expected.

RR - Respiration rate, typically given in breaths per minute.

RS101 - Magnetic Fields Susceptibility Test Standard (MIL-STD-462D).

RS232 - Physical interface standard for use between data communications equipment and data

terminal equipment.

Sample Chamber - The area within a measurement device where the (CO2) analysis takes

place.

Sample Line - A tube, or tubing, used to transport a patient’s expired gas to the monitor or CO2

inlet port.

Secondary Shutoff Pellet - A small device used in the internal pneumatics designed to inhibit

ﬂow when exposed to water.

Self Reset - The Module returns to its original state due to a condition other than a watchdog

timeout.

Sensor Fault - An error associated speciﬁcally with the CO2 sensor.

Sensor Signal - The output of the CO2 bench or CCap.

Welch Allyn OEM Technologies Conﬁdential Page 95

LC101 CO2 Module OEM Implementation Manual

Set Flow Rate - The rate of ﬂow commanded by the host system. The actual ﬂow rate must be

within +15, -20% of this setting.

Short Watertrap Receiver - A Welch Allyn OEM Technologies accessory that mechanically

interfaces the Welch Allyn OEM Technologies watertrap with the host system. The short receiver positions into the host system leaving a large part of the watertrap exposed externally. (See Long Watertrap Receiver.)

Sidestream Sampling - CO2 analysis which is accomplished within a device. The patient’s

expired gas is aspirated from the airway and drawn to the device through a sample line.

Simple Command - A host communication to the Module to request data or a status change.

Data is not sent with these commands.

Simple Response - The Module communication to the host in reply to a command.

Soft Fault - Condition that interrupts Module operation, including transmission of CO2 waveform

and breath data packets, until the fault is cleared.

Software Reset - A speciﬁc command that clears the Module and returns it to its original mode

and EEPROM default conﬁguration settings.

SS - Sidestream.

SS Components - Parts that comprise an entire sidestream system such as the pump, tubing,

ﬁttings and watertrap.

SS System - An end-to-end method to measure the patients expired gas by aspirating a gas

sample from the airway and drawing it through a sample line to a measurement device.

Standby Mode - Module mode that disables the source, pump and data packets. It is typically

used when a low power, standby state, is desired.

Status Response - Data packets from the Module that communicate sensor or Module status.

The status response also serves as an acknowledgemnet for mode commands.

Steady State Measurement - A continuous measurement of CO2 taken without regard to patient

respiratory rate. It is normally used during calibration, or when monitoring the presence of background CO

. Usually the breath data update is disabled during

steady state measurements.

System Fault - An error associated speciﬁcally with the Main Board.

Thermistor - A resistor that has a large nonlinear temperature coefﬁcient of resistance. Typically

used for temperature measurement feedback.

Page 96 Conﬁdential Welch Allyn OEM Technologies

LC101 CO2 Module OEM Implementation Manual

Trachea - A passageway (the “wind pipe”) that conducts air from the larynx to the main stem

bronchi.

Tracheostomy - The cutting of an opening into the trachea.

User - The end-user or operator of the device.

Ventilator - A machine or device that provides a constant supply of oxygen and/or air to the

lungs by the movement of gas into and out of the pulmonary system.

Ventilator’s Wye Piece - The section of a ventilator circuit that separates inspiratory and

expiratory limbs.

Watchdog - A failure detection mechanism internal to the microprocessor.

Watchdog Reset - A reset caused by a watchdog timeout.

Watchdog Timeout - A condition where the microprocessor internal failure mechanism has not

detected a response to an internal inquiry within a given timeframe.

Glossary

Welch Allyn OEM Technologies Conﬁdential Page 97

LC101 CO2 Module OEM Implementation Manual

Page 98 Conﬁdential Welch Allyn OEM Technologies

Welch Allyn LC101 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Intr oduction

Intended Use

Terminology

Mainstream vs. Sidestream

Measuring Principle

Measurement Calculation

Measurement Compensation

Hardware Components

LC101 Main Board

Sidestream Components

Power Requirements

LC101 Main Board

LC101 Module Interface Connector

Watertrap Switch Connection

Pump

Watertrap Receiver

Watertrap Receiver Switch

Exhaust Tubing

Zero Calibration

Zero Calibration Procedure

Two-Point User Calibration

Two-Point User Calibration Procedure

Troubleshooting

Communication Interface

System EEPROM

Packet Structure

Host Commands

Mode Commands

Simple Commands

Calibration Commands

Module Responses

Status Responses

Mode Command Responses

Simple Command Responses

Calibration Command Responses

Software Protocol

Packets

Faults

Module Resets

System Behaviors - Dynamic Communications

Normal Flow

Pneumatic Events

Total Inlet Occlusion

Partial Inlet Occlusion

Total Exhaust Occlusion

Partial Exhaust Occlusion

Barometric Out Of Range

Unexpected Reverse Flow

Unexpected Forward Flow

Internal Disconnects

Watertrap Receptacle

Sensor Inlet/Outlet

Flow Control Circuitry

Pump Inlet

Pump Exhaust

Pump Failure

Low Flow

High Flow

No Flow

IEC 601-1-2 (EN 60601-1-2)

Welch Allyn OEM Technologies

Electromagnetic Interference

Electromagnetic Susceptibility

Compliance Testing Summary

ISO 9918 and EN 864

Percent CO2 Calculation

Zero Calibration Sequence Example

Two-Point User Calibration Sequence Example

CCITT/CRC Code Calculation

Software Upgrade

System EEPROM Map Table

Advisories

LC101 Advisories

Pneumatic System Advisories

Calibration Advisories

Soft Faults