Nellcor N85 User manual
Portable Bedside Capnograph/Pulse Oximeter
Service Manual
CI05225E
Notice: Purchase of this instrument confers no express or implied license under any Oridion
Medical patent or Nellcor Puritan Bennett patent to use the instrument with any accessory that is
not manufactured or licensed by Oridion Medical 1987 Ltd.
Capnography is covered by one or more of the following United States patents: 6,491,643;
6,656,127; 6,168,958; 5,300,859 and 4,755,675 and their foreign equivalents
この製品は、次の日本における特許、1980816と海外での同等のものによって保護されて
居ります。
Microstream
Smart BiteBloc™ and NIV Line™ are trademarks of Oridion Medical 1987 Ltd.
Nellcor Puritan Bennett Incorporated is an affiliate of Tyco Healthcare.
The following are trademarks of Nellcor Puritan Bennett Incorporated: Oxiband
OxiCliq
Pulse Oximetry is covered by one or more of the following US patents and foreign equivalents:
4,802,486; 4,869,254; 4,928,692; 4,934,372; 5,078,136; 5,485,847; 5,743,263; 5,865,736;
6,035,223; 6,298,252; 6,463,310; 6,591,123; 6,675,031; 6,708,049; 6,801,797; Re 35,122.
®
and FilterLine® are registered trademarks and Smart CapnoLine™, CapnoLine™,
®
; Dura-Y®; and OXIMAX®.
.
®
; Durasensor®;
TABLE OF CONTENTS
List of Figures
List of Tables
Section 1: Introduction........................................................................ 1-1
Section 2: Required Equipment.......................................................... 2-1
Section 3: Cleaning ........................................................................... 3-1
Section 4: Service Mode...................................................................... 4-1
Section 5: Troubleshooting................................................................. 5-1
Section 6: Flow Calibration Check ..................................................... 6-1
Section 7: Disassembly Guide............................................................ 7-1
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
2.1 Required Equipment .......................................................... 2-1
3.1 Cleaning ........................................................................... 3-1
3.1.1 Procedure........................................................... 3-1
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.................................................. 4-9
4.3.3 Flow Calibration ............................................... 4-10
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
6.1 Introduction ........................................................................ 6-1
6.2 Flow Rate Check ...............................................................6-1
6.3 Flow Calibration Process ................................................... 6-2
7.1 Introduction ........................................................................ 7-1
7.2. Opening the Monitor Case.................................................7-2
7.3 Replacing the CO
7.4 Replacing the SpO
2 Board .................................................. 7-4
2 Board................................................. 7-5
7.5 Replacing the Pump ..........................................................7-6
7.6 Replacing the Flow System ...............................................7-7
7.6.1 Replacing the lines to the pump.........................7-8
7.6.2 Replacing the lines to the solenoid ....................7-9
7.7 Replacing LCD and LED Display..................................... 7-11
7.7.1 Replacing the LCD ........................................... 7-11
7.7.2 Replacing the LED Display .............................. 7-11
iii
Table of Contents
7.8 Replacing Housing Components ..................................... 7-12
7.8.1 ON-OFF Button and Gas Outlet....................... 7-12
7.8.2 Keypads ...........................................................7-12
7.8.3 Front Cover ......................................................7-13
7.8.4 SpO
Connector Latch, Rear Cover and
2
SpO
Insulation Plate .......................................7-13
2
7.9 Updating Software Version .............................................. 7-14
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 Monitor 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
12.4.1 Capnograph ..................................................... 12-2
12.4.2 Pulse Oximeter................................................. 12-3
12.5 Power Specifications ....................................................... 12-4
12.5.1 External Power Source .................................... 12-4
12.5.2 Internal Power Source...................................... 12-4
12.6 Components and User interface ...................................... 12-4
12.6.1 Displays............................................................ 12-4
12.6.2 Controls and Indicators .................................... 12-4
12.6.3 Connections ..................................................... 12-4
Section 13: Spare Parts..................................................................... 13-1
13.1 Spare Parts List ............................................................... 13-1
Glossary of Terms
iv
Table of Contents
LIST OF FIGURES
LIST OF TABLES
1-1 Handheld Capnograph/Pulse Oximeter............................. 1-2
1-2 LCD Graphic Display and 7 Segment Digital Displays ......1-2
7-1 Removing the Battery Pack ............................................... 7-2
7-2 Removing Mounting Screws.............................................. 7-3
7-3 Separating Rear and Front Covers.................................... 7-3
7-4 Replacing CO
7-5 Replacing SpO
2 Board and Housing Components.............. 7-4
2 Board....................................................... 7-5
7-6 Replacing the Pump .......................................................... 7-6
7-7 Flow System ......................................................................7-7
7-8 Main Line ........................................................................... 7-8
7-9 Exhaust Line...................................................................... 7-8
7-10 Lines to Solenoid (Zero line, Input line 1, Input line 2........ 7-9
7-11 Zero line........................................................................... 7-10
7-12 Replacing LCD and LED Display.....................................7-11
7-13 Replacing SpO
2 Connector Latch.................................... 7-13
7-14 Replacing EPROM........................................................... 7-14
10-1 Leak Test Jig Connection ................................................10-1
10-2 Initialization Screen.......................................................... 10-2
10-3 Self-Test Screen .............................................................. 10-2
10-4 Measuring Mode .............................................................. 10-2
10-5 Quick Guide ..................................................................... 10-3
10-6 Connecting the monitor to Printer/PC with
Communication Adapter Kit ............................................. 10-9
11-1 Packing the Monitor in Original Packing .......................... 11-2
4-1 Accessing Service Mode and Changing Parameter
Settings................................................................... 4-3
4-2 Accessing Service Level 2................................................. 4-5
4-3 Changing Default Alarm Limits .......................................... 4-7
4-4 Changing Default Settings................................................. 4-9
4-5 Accessing Flow Calibration.............................................. 4-10
5-1 Troubleshooting Guide ...................................................... 5-2
5-2 Advisory Messages Guide.................................................5-4
5-3 Event Messages ................................................................ 5-5
6-1 Flow Calibration................................................................. 6-2
10-1 CO
2 Calibration Check..................................................... 10-4
10-2 Calibration Process.......................................................... 10-6
10-3 Calibration Process -Troubleshooting.............................. 10-7
10-4 Plethysmograph Waveform ............................................. 10-8
10-5 Accessing Monitor’s Print Functions.............................. 10-10
13-1 Spare Parts List ............................................................... 13-1
v
Table of Contents
SECTION 1: INTRODUCTION
1.1 Manual Overview
1.2 Warnings, Cautions, and Notes
1.3 Product Description
1.1 MANUAL OVERVIEW
This manual contains information for servicing the handheld capnograph/
pulse oximeter (the monitor). Only authorized service personnel should
service this product. The Handheld Capnograph/Pulse Oximeter
Operator’s Manual (the 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
1.2.2 Caution
1.2.3 Note
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.
A caution precedes an action that may result in damage to, or malfunction
of, the monitor. Cautions are highlighted in boldface type.
A note gives information that requires special attention.
1-1
Section 1: Introduction
1.3 PRODUCT DESCRIPTION
The handheld capnograph/pulse oximeter is used to continuously monitor
end-tidal carbon dioxide (EtCO
2), and pulse rate. The monitor is for attended monitoring only and
(SpO
must be used in the continuous presence of a qualified healthcare
provider. The monitor can be used on adult, pediatric, and infant/neonatal
patients. It is intended for use 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
operates on AC power or a rechargeable Nickel Metal Hydride battery
pack.
2), respiratory rate, oxygen saturation
1-2
Figure 1-1: Handheld Capnograph/Pulse Oximeter
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 LCD graphic display (LCD) as shown in Figure 1-2. Refer to the
operator’s manual for complete operating instructions.
Figure 1-2: LCD Graphic Display and 7-Segment Digital Displays
SECTION 2: REQUIRED EQUIPMENT
2.1 Required Equipment
2.1 REQUIRED EQUIPMENT
You will need the following equipment to disassemble, replace parts,
check, adjust, or calibrate the monitor.
For disassembly and replacement:
• Phillips-head screwdriver (medium)
• Flat-head screwdriver (small)
• IC Extractor for PLCC socket
• Threadlocker glue e.g. Loctite
For checks, adjustments and calibration:
®
222 super screw lock
• Calibration Gas (5% CO
2 in air)
• FilterLine or FilterLine H and a connecting means
• DS-100A - O
XIMAX Durasensor
®
, Nellcor
• Leak Test Jig
• Vacuum manometer with a range of 0-500 mBar
e.g. MPL-3200-DM, Digital Manometer MicroPneumatic Logic, Inc.
• Communication Adapter Kit (only necessary to verify print functions)
• Seiko DPU-414 printer (only necessary to verify print functions)
• External power supply
• Handheld Capnograph/Pulse Oximeter Operator’s Manual
• Flow Meter (range 0-50 ml/min) 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’s internal components.
2-1
SECTION 3: CLEANING
3.1 Cleaning
3.1 CLEANING
Always clean the outer surface of the monitor before servicing.
Warning: Always wear latex or surgical gloves when cleaning
or servicing the monitor after hospital use.
Warning: Do not allow liquids to drip inside the housing.
Warning: Do not clean internal components.
Warning: Do not use preparations based on: phenols, halogen
producing compounds, strong organic acids, or oxygen
producing compounds.
3.1.1 Procedure
1. Unplug the unit from AC power.
2. With a damp cloth, gently wipe the outer case of the monitor with a
disinfectant based on aldehyde, alcohol or quaternary ammonium
producing compounds.
3-1
SECTION 4: SERVICE MODE
4.1 Introduction
4.2 Service Level 1
4.3 Service Level 2
4.1 INTRODUCTION
The monitor supports a service mode built into the instrument’s firmware.
To access the service mode, refer to Table 4-1: "Accessing Service Mode
and Changing Parameter Settings".
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
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: "Accessing Service Mode and Changing Parameter
Settings".
4.2.1 Information Screen
The information screen displays the monitor’s main board serial number,
the number of operating hours, and the SpO
versions.
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 three event messages and each
has a specific response as follows:
2 and CO2 boards’ software
Event Message: Action:
2 board Replace CO2 board
CO
2
board Replace SpO2 board
SpO
Flow Replace CO
2 board
4-1
Section 4: Service Mode
Note: To exit the service mode and save event messages, turn off the
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)
monitor. Event messages will be erased when exiting the service
mode by a long press of .
•CO
2 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 display (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 environment. A
higher threshold value saves on battery power consumption.
4-2
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. Refer to
Table 4-1: "Accessing Service Mode and Changing Parameter Settings".
4.2.3.4 CO
The CO
2 Calib. (calibration)
2 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
procedure.
4.2.4 Accessing Service Mode and Service Level 1.
Table 4-1: "Accessing Service Mode and Changing Parameter Settings"
describes the process 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
Section 4: Service Mode
To access Service Mode During self-test,
long press
simultaneously
and
To access Event
Messages screen
To access Interface
Test screen
long press
long press
Self-test occurs and the
Information Screen
appears:
To change the
parameter setting or
value
To move to the next
parameter
short press
short press
4-3
Section 4: Service Mode
Table 4-1: Accessing Service Mode and
Changing Parameter Settings (Continued)
Objective Action Response
To change Contrast
short press
Cal. setting to set
To start Contrast Cal. short press “Contrast Cal.” flashes.
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)
To exit service mode
from any service
screen without erasing
the event messages
memory
long press
Note: Reset time is
approximately one
minute.
Turn off the
monitor.
4-4
4.3 SERVICE LEVEL 2
Section 4: Service Mode
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: "Accessing Service Level 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
Enter Password: 1627
Enter the 1st digit short press (right)
Move to the next digit short press
After entering the service mode
long press (x3)
(x1)
Pressing on the right arrow scrolls the numbers up, the left arrow scrolls the numbers down.
Password Screen
appears
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 Response
To accept the last digit
and access the Default
Alarm Limits menu
In case you entered a
wrong digit:
To restart password
validation process
To return to the
Interface Test Screen
short press
long press
long press
To exit service mode
and save event
messages
Turn off the
monitor.
4-6
4.3.1 Default Alarm Limits
The service technician can change the default alarm limits for either
patient mode (Adult or Neonatal) as described in Table 4-3: "Changing
Default Alarm Limits".
The monitor has the following alarms with adjustable level settings:
Section 4: Service Mode
•EtCO
•FiCO
•SpO
2 high and low levels (mmHg)
2 high level (mmHg)
2 high and low levels (%)
• Pulse rate high and low levels (bpm)
Warning: Changing default settings will permanently change the
user’s start-up value and should be verified with the responsible
clinical personnel.
Table 4-3: Changing Default Alarm Limits
Objective Action Response
To access the Default
short press Alarm Limits menu after entering last password digit
To change the patient
short press
mode
To access a new
short press
parameter
To change the value short press
4-7
Section 4: Service Mode
Table 4-3: Changing Default Alarm Limits (Continued)
Objective
To reset to measuring
mode (automatically
erasing event
messages)
To exit service mode
and save event
messages
Action
long press
then long press
Turn off the
monitor.
Response
4-8
4.3.2 Default Settings
Section 4: Service Mode
The service technician can change two default settings (refer to Table 4-4:
"Changing Default Settings"):
•3 Min Alert
When the 3 Min Alert is ON, the unit will beep every three minutes
to remind the user that an alarm (or all alarms) are set to OFF.
• BTPS (body temperature, pressure, saturation)
When BTPS is ON, the CO
2 value is corrected for this factor
• Pulse Tone
Pulse Tone default is ON. When changed to OFF, the Pulse Tone
default is silent (as indicated on screen).
.
Table 4-4: Changing Default Settings
Objective Action Response
To access the Default
Settings menu (after
accessing the Default
Alarm Limits menu)
To change the setting short press
To access BTPS
parameter (and save
the changed setting for
3 Min Alert)
To reset and return to
measuring mode
(automatically erasing
event messages
memory)
long press
short press
long press
To exit service mode
and save event
message
Turn off the
monitor.
4-9
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