NPB-70 Handheld Capnograph Service Manual Rev A Oct 2003

Mallinckrodt Inc. 675 McDonnell Boulevard PO. Box 5840 St. Louis, MO 63134 Tel 314.654.2000 Toll Free 1.800.635.5267 Nellcor Puritan Bennett 4280 Hacienda Drive Pleasanton, CA 94588 Mallinckrodt Europe BV Hambakenwetering 1 5231 DD ‘s-Hertogenbosch The Netherlands Tel. +31.73.6485200

To obtain information about a warranty, if any, for this product, contact Mallinckrodt Technical Services or your local Mallinckrodt representative. Purchase of this instrument confers no express or implied license under any Mallinckrodt patent to use the instrument with any sensor that is not manufactured or licensed by Mallinckrodt.

Capnography covered by one or more of the following U.S. Patents and foreign equivalents: 4,755,675; 5,063,275; 5,300,859; and 5,657,750

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TABLE OF CONTENTS List of Figures List of Tables

Section 1: Introduction... 1-1 1.1 Manual Overview ... 1-1 1.2 Warnings, Cautions, and Notes ... 1-1 1.2.1 Warning... 1-1 1.2.2 Caution... 1-1 1.2.3 Note... 1-1 1.3 Product Description ... 1-2 Section 2: Required Equipment ... 2-1 2.1 Required Equipment ... 2-1 Section 3: Cleaning ... 3-1 3.1 Cleaning ... 3-1 3.1.1 Procedure... 3-1 Section 4: Service Mode ... 4-1 4.1 Introduction ... 4-1 4.2 Service Level 1 ... 4-1 4.2.1 Information Screen... 4-1 4.2.2 Event Messages Screen ... 4-1 4.2.3 Interface Test Screen... 4-2 4.2.4 Accessing Service Mode and Service Level 1 ... 4-3 4.3 Service Level 2 ... 4-5 4.3.1 Default Alarm Limits ... 4-7 4.3.2 Default Settings... 4-8 4.3.3 Flow Calibration ... 4-9 Section 5: Troubleshooting ... 5-1 5.1 Introduction ... 5-1 5.2 Who Should Perform Repairs ... 5-1 5.3 Repair Level Supported ... 5-1 5.4 How to Use This Section ... 5-1 5.5 Obtaining Replacement Parts... 5-1 5.6 Troubleshooting Guide ... 5-2 Section 6: Flow Calibration Check ... 6-1 6.1 Introduction ... 6-1 6.2 Flow Rate Check ... 6-1 6.3 Flow Calibration Process ... 6-2 Section 7: Disassembly Guide ... 7-1 7.1 Introduction ... 7-1 7.2. Opening the Handheld Capnograph Case... 7-2 7.3 Replacing the CO2 Board ... 7-4 7.4 Replacing the Pump Assembly... 7-5 7.5 Replacing the Flow System ... 7-6 7.5.1 Replacing the lines to the pump... 7-7 7.5.2 Replacing the lines to the solenoid ... 7-8 7.6 Replacing LCD and 7-Segment Display ... 7-10 7.6.1 Replacing the LCD ... 7-10 7.6.2 Replacing the 7-Segment Display... 7-10

iii

Table of Contents

7.7

Replacing Housing Components ... 7-11 7.7.1 ON/OFF Button and Gas outlet... 7-11 7.7.2 Keypads ... 7-11 7.7.3 Front Cover ... 7-11 7.74 Rear Cover... 7-11 7.8 Updating Software Version ... 7-12 Section 8: Electrical Safety Tests ... 8-1 8.1 Electrical Safety Tests ... 8-1 Section 9: Periodic Maintenance ... 9-1 9.1 Periodic Maintenance ... 9-1 Section 10: Performance Verification... 10-1 10.1 Flow System Leak Check ... 10-1 10.1.1 Flow System Leak Check Procedure ... 10-1 10.2 Performance Verification Procedure... 10-2 Section 11: Packing For Shipment ... 11-1 11.1 General Instructions... 11-1 11.2 Packing Handheld Capnograph in Original Carton... 11-1 11.3 Packing in a Different Carton... 11-1 Section 12: Specifications... 12-1 12.1 Physical ... 12-1 12.1.1 Size ... 12-1 12.1.2 Weight ... 12-1 12.1.3 Noise Emission ... 12-1 12.2 Environmental... 12-1 12.2.1 Temperature... 12-1 12.2.2 Relative Humidity ... 12-1 12.2.3 Pressure and Altitude... 12-1 12.3 Safety Standards ... 12-1 12.4 Performance ... 12-2 12.5 Power Specifications ... 12-3 12.5.1 External Power Source ... 12-3 12.5.2 Internal Power Source... 12-3 12.6 Components and User interface ... 12-3 12.6.1 Displays... 12-3 12.6.2 Controls and Indicators ... 12-3 12.6.3 Connections ... 12-3 Section 13: Spare Parts ... 13-1 13.1 Spare Parts List ... 13-1 Glossary of Terms

iv

Table of Contents

LIST OF FIGURES 1-1 1-2 7-1 7-2 7-3 7-4 7-5 7-6 7-7 7-8 7-9 7-10 7-11 7-12 10-1 10-2 10-3 10-4 10-5 11-1

Handheld Capnograph... 1-2 LCD Screen and 7-Segment Digital Display... 1-2 Removing the Battery Pack ... 7-2 Removing Mounting Screws ... 7-3 Separating Rear and Front Covers... 7-3 Replacing CO2 Board and Housing Components... 7-4 Replacing the Pump ... 7-5 Flow System ... 7-6 Main Line ... 7-7 Exhaust Line ... 7-7 Lines to Solenoid (Zeo line, Input line 1, Input line 2 ... 7-8 Zero line... 7-9 Replacing LCD and 7-Segment Display ... 7-10 Replacing EPROM... 7-12 Leak Test Jig Connection ... 101 Initialization Screen... 10-2 Measuring Mode ... 10-2 Quick Guide ... 10-3 Connecting the monitor to Printer/PC with Communication Adapter Kit ... 10-7 Packing the NPB-75 in Original Packing ... 11-2

LIST OF TABLES 4-1 4-2 4-3 4-4 4-5 5-1 5-2 5-3 6-1 10-1 10-2 10-3 10-4 13-1

Accessing Service Mode and Changing Parameter Settings... 4-3 Accessing Service Level 2... 4-5 Changing Default Alarm Limits ... 4-7 Changing Default Settings ... 4-8 Accessing Flow Calibration... 4-9 Troubleshooting Guide ... 5-2 Advisory Message ... 5-4 Event Messages ... 5-5 Flow Calibration ... 6-2 CO2 Calibration Check... 10-3 Calibration Process... 10-5 Calibration Process -Troubleshooting... 10-6 Accessing Handheld Capnograph Print Functions ... 10-8 Spare Parts List ... 13-1

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SECTION 1: INTRODUCTION 1.1 1.2 1.3 1.1

Manual Overview Warnings, Cautions, and Notes Product Description

MANUAL OVERVIEW

This manual contains information for servicing the Handheld Capnograph (the monitor). Only qualified service personnel should service this product. The Handheld Capnograph Operator’s Manual is an integral part of the service procedures. Before servicing the monitor, read the Operator’s Manual carefully for a thorough understanding of how to operate the unit. Only use the tools and test equipment as specified in this manual. Only use original spare parts available from your local distributor.

Warning: Incorrect procedures may harm the patient, or damage the monitor. 1.2

WARNINGS, CAUTIONS, AND NOTES

1.2.1

Warning

A warning precedes an action that may result in injury or death to the patient or user. Warnings are boxed and highlighted in boldface type. 1.2.2

Caution

A caution precedes an action that may result in damage to, or malfunction of, the monitor. Cautions are highlighted in boldface type. 1.2.3

Note

A note gives information that requires special attention.

1-1

Section 1: Introduction

1.3

PRODUCT DESCRIPTION

The device is a Handheld Capnograph that continuously monitors end tidal carbon dioxide (EtCO2) and respiratory rate. The monitor is for attended monitoring only and must be used in the continuous presence of a qualified healthcare provider. It is intended for use in any environment where continuous, noninvasive monitoring of these parameters is desired, including hospital and mobile use (when protected from excessive moisture such as direct rainfall). The monitor is intended for use on adult, pediatric, and infant/neonatal patients.

Figure 1-1: Handheld Capnograph

The monitor is operated using a four-key keypad. Measurements are displayed on the front panel on the 7-segment LED digital displays (LED) and on the Liquid Crystal graphic display (LCD) as shown in Figure 1-2. Refer to the Handheld Capnograph Operator’s Manual for complete operating instructions.

Figure 1-2: LCD Screen and 7-Segment Digital Display

1-2

SECTION 2: REQUIRED EQUIPMENT 2.1

2.1

Required Equipment

REQUIRED EQUIPMENT

You will need the following equipment to disassemble, replace parts, check, adjust, or calibrate the monitor. Note: For ordering spare parts, contact your local distributor. For Disassembly and Reasssembly: • Phillips-head screwdriver (medium) • IC Extractor for PLCC socket • Threadlocker glue e.g. Loctite® 222 super screw lock For Calibration, Checks and Adjustments: • Calibration Gas (5% CO2 in air) • FilterLine or FilterLine H • Leak Test Jig • Vacuum manometer with a range of 0-500 mBar e.g. MPB-3200-DM, Digital Manometer MicroPneumatic Logic, Inc. • Communication Adapter Kit (only necessary to verify print and PC functions) • Seiko DPU-414 printer (only necessary to verify print functions) • External power supply • Handheld Capnograph Operator’s Manual • Flow Meter e.g. Top Track Mass Flow Meter, model: 822-13-OV1-PV1-V1, Sierra Instruments, Inc.

Warning: Observe ESD (electrostatic discharge) precautions when handling, adjusting or performing any procedure with the monitor internal components.

2-1

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SECTION 3: CLEANING 3.1

3.1

Cleaning

CLEANING

Always clean the outer surface of the monitor before servicing. Warning: Always wear latex or surgical gloves when cleaning or servicing the Handheld Capnograph monitor after hospital use.

Warning: Do not allow liquids to drip inside the housing.

Warning: Do not clean internal components.

Warning: Do not use cleaning materials based on: phenols, halogen producing compounds, strong organic acids, or oxygen producing compounds.

3.1.1

Procedure

1.

Unplug the unit from AC mains supply.

2.

With a damp cloth, gently wipe the outer case of the monitor with a disinfectant basd on aldheyde, alcohol or quaternary ammonium producing compounds.

3-1

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SECTION 4: SERVICE MODE 4.1 4.2 4.3 4.1

Introduction Service Level 1 Service Level 2

INTRODUCTION

The monitor supports a service mode built into the instrument’s firmware. The architecture of the monitor’s service mode divides the service mode into two levels as described in the sections below. • Service Level 1 • Service Level 2 To access the service mode (levels 1 and 2), refer to Tables 4-1 and 4-2. 4.2

SERVICE LEVEL 1

The Service Level 1 provides information and tools on three service screens to test and calibrate specific functions without disassembling the monitor. • Information Screen • Event Messages Screen • Interface Test Screen From these display screens the service technician can check the operating hours counter and event messages, test the Human Interface functions (HMI), set the light detection threshold, adjust the LCD contrast middle point and do a calibration check and a calibration process, if necessary. Refer to Table 4-1. 4.2.1

Information Screen

The information screen displays the monitor’s serial CO2 board number, the number of operating hours, and the CO2 board’s software version. 4.2.2

Event Messages Screen

The monitor automatically performs a series of built-in tests (BITs) at start-up and during operation to check sub-systems and modules for errors. The event messages screen lists the last five event messages, the time each occurred relative to the unit’s operating hours, and a recommended service action. There are two event messages and each has a specific response as follows: Event Message:

Action:

CO2 board

Replace CO2 board

Flow

Replace Flow System and/or Pump Refer to Section 5: Troubleshooting

4-1

Section 4: Service Mode

Note: To exit the service mode and save event messages, turn off the monitor. Event messages will be erased when exiting the service mode by a long press of . 4.2.3

Interface Test Screen

The interface test screen shows four parameters (listed below) that provide tools for the user to test, adjust, and calibrate the unit’s interfacing systems. • HMI Test • Light Detector • Contrast Cal. (Calibration) • CO2 Calib. (Calibration) 4.2.3.1 HMI Test When the HMI Test is turned on, the monitor performs a self-test of the following sub-systems: • Buzzer (sounds for one second) • LCD graphic screen shows a checkerboard pattern • 7-segment digital display (8s scroll left to right) • Alarm bar (lights red, yellow, off) • Backlight (turns on and off) • Alarm silence indicator (light turns on and off) When the HMI test is completed the status field returns automatically to “OFF”. 4.2.3.2

Light Detector

The Light Detector parameter allows the service technician to set the threshold value of the phototransistor. The default value is 1 and the range is from 1 to 5 with 1 as the most sensitive (backlight on at all times) and 5 as the least sensitive (backlight off). The threshold value should be set according to the lighting conditions of the working enviroment. A higher threshold value saves on battery power consumption. Note: When the monitor’s power management is set to Low, the backlight is off.

4-2

Section 4: Service Mode

4.2.3.3

Contrast Cal. (calibration)

The Contrast Cal. gives the service technician the option to change the middle point default value of the contrast intensity of the LCD. Table 4-1 describes how to change the contrast cal. settings. 4.2.3.4

CO2 Calib. (calibration)

The CO2 Calib. allows the service technician to perform a calibration check and calibration process to ensure the accuracy of the monitor. Section 10: Performance Verification describes the calibration check and calibration process procedure. 4.2.4

Accessing Service Mode and Service Level 1.

Table 4-1 describes how to access the service mode, change parameter settings and how to change Contrast Cal. settings. Table 4-1: Accessing Service Mode and Changing Parameter Settings Objective

Action

Response

To access Service Mode During self-test, press and hold simultaneously

Self-test occurs and the Information Screen appears:

and

To access Event Messages

long press

To access Interface Test Screen

long press

To change the parameter setting or value

short press

4-3

Section 4: Service Mode

Table 4-1: Accessing Service Mode and Changing Parameter Settings (Continued) To move to the next parameter (moving to the next parameter accepts and saves changed values)

short press

To change Contrast Cal. setting to set

short press

To start Contrast Cal.

short press

To Adjust Contrast Cal. middle point

press Screen lightens or darkens until desired setting is reached. (Pressing on the left lightens the screen, and pressing on the right darkens the screen.)

To accept new setting

short press

To reset and return to measuring mode (automatically erasing the event messages memory)

long press

To exit service mode Turn off the from any service monitor screen without erasing the event messages memory

4-4

“Contrast Cal.” flashes.

Section 4: Service Mode

4.3

SERVICE LEVEL 2

The Service Level 2 gives the service technician tools on three service screens: • Default Alarm Limits • Default Settings • Flow Calibration To access this service level, the service technician must enter a valid password (1627), refer to Table 4-2. Note: The password should not be disclosed to avoid unauthorized setting of parameters. Table 4-2: Accessing Service Level 2 Objective

Action

Response

To access Service Level 2

After entering the service mode

Password Screen appears

long press x3

Enter Password: 1627 Enter the 1st digit

short press (right) x1

Pressing on the right arrow scrolls the numbers up, the left arrow scrolls the numbers down. Move to the next digit

short press

Enter the 2nd digit

short press (right) x6

Repeat the same procedure as above for the next two digits (2, 7).

4-5

Section 4: Service Mode

Table 4-2: Accessing Service Level 2 (Continued) Objective

Action

To access the Alarm short press Limits Menu after entering last password digit

In case you entered a wrong digit

To restart password validation process

long press

To reset and return to long press measuring mode (automatically erasing event messages)

To exit service mode and save event messages

4-6

Turn off the monitor.

Response