Caution: Federal law (U.S.) restricts this device to sale by or on the order of a physician.
To contact Mallinckrodt, Inc. representative: In the United States, call 1-800-635-5267: outside the United States,
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
13-1Spare Parts List...............................................................13-1
v
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SECTION 1: INTRODUCTION
1.1Manual Overview
1.2Warnings, Cautions, and Not es
1.3Product Description
1.1 MANUAL OVERVIEW
This manual contains information for servicing the Handheld
Capnograph (the monito r). Only qualified service personnel sh ould
service this product. The H andheld Capnograph Oper ator’s Man ual is an
integral part of the service procedures. Before servic ing 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
1.2.1Warning
1.2.2Caution
1.2.3Note
A warning precedes an action that may result in injury or death to the
patient or user. Warning s are boxed and highlighted in boldface type.
A caution precedes an acti on that may result in damage to, or malf unction
of, the monitor. Cautions are highlighted in boldface type.
A note gives information that requires special attention.
1-1
Section 1: Introduction
1.3PRODUCT DESCRIPTION
The device is a Handheld Capnograph that continuously monitors end
tidal carbon dioxide (EtCO
attended moni toring onl y and must be us ed in the contin uous pres ence o f
a qualified healthcare provider . It is intended for us e in any en vironment
where continuous, noninvasive monitoring of these parameters is desired,
including hospital and mob ile use (when protected from excessive
moisture such as direct rainfall).
The monitor is intended for use on adult, pediatric, and infant/neonatal
patients.
2) and respiratory rate. The monitor is for
Figure 1-1: Handheld Capnograph
The monitor is operated using a four-key keypad. Measurements are
displayed on the front panel on the 7-segmen t 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
2.1Required Equip ment
2.1REQUIRED EQUIPMENT
You will need the followin g 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 Adju stments:
• Calibration Gas (5% CO
• FilterLine or FilterLine H
• Leak Test Jig
• Vacuum manometer wit h 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 in air)
2-1
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SECTION 3: CLEANING
3.1Cleaning
3.1CLEANING
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.
3.1.1Procedure
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 o r quaternary a mmonium
producing c ompounds.
3-1
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SECTION 4: SERVICE MODE
4.1Introduction
4.2Service Level 1
4.3Service Level 2
4.1INTRODUCTION
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.
4.2SERVICE LEVEL 1
The Service Level 1 provides information and tools on three service
screens to test and calibra te spec ific f unc tion s withou t disa ssemb li ng the
monitor.
• Information Screen
• Event Messages Screen
• Interface Test Screen
From these display screens the service techni cian can check the operating
hours counter and event messages, test the Human Interface functions
(HMI), set the light detection threshold, adju st the LCD contrast middle
point and do a calibration chec k and a calibration process, if necessary.
Refer to Table 4-1.
4.2.1Information Screen
The information screen displays the monitor’s serial
CO
2 board number, the number of operating hours, and the
CO
2 board’s software version.
4.2.2Event 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 an d each has
a specific response as follows:
Event Message:Action:
CO
2 boardReplace CO2 board
FlowReplace 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
4.2.3Interface Test Screen
The interface test screen shows four parameters (listed below) that
provide tools for the user to test, adjust, an d ca librate 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 Te s t 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”.
4.2.3.2Light Detector
The Light Detector parameter allows the service technician to set the
threshold value of the phototransistor. Th e default value is 1 and the
range is from 1 to 5 with 1 as the most sensitiv e (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.
4-2
Note: When the monitor’s power management is set to Low, the backlight
is off.
Section 4: Service Mode
4.2.3.3Contrast 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.
4.2.3.4CO
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 and
calibration process procedure.
4.2.4Accessing 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
ObjectiveActionResponse
To access Service Mode During self-test,
press and hold
simultaneously
Changing Parameter Settings
Self-test occurs and the
Information Screen
appears:
and
To access Event
Messages
To access Interface
Test Screen
To change the
parameter setting or
value
long press
long press
short press
4-3
Section 4: Service Mode
Table 4-1: Accessing Service Mode and
Changing Parameter Settings (Continued)
To move to the next
short press
parameter (moving to
the next parameter
accepts and save s
changed values)
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 settingshort press
4-4
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
Turn off the
monitor
4.3SERVICE 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.
Note: The password should not be disclosed to avoid unauthorized setting
of parameters.
Table 4-2: Accessing Service Level 2
ObjectiveActionResponse
To access Service
Level 2
Enter Password: 1627
Enter the 1st digitshort press (right)
Move to the next digitshort 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 digitshort 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)
ObjectiveActionResponse
To access the Alarm
Limits Menu after
entering last password
digit
In case you entered a
wrong digit
To restart password
validation process
To reset and return to
measuring mode
(automatically erasing
event messages)
short press
long press
long press
To exit service mode
and save event
messages
Turn off the
monitor.
4-6
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