Technical Service Manual
Alaris® SpO2 Modules
8210 Series (Nellcor
8220 Series (Masimo
ONI
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R
S
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L
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%SpO
2
PULSE (BPM)
®
Technology)
®
Technology)
Supports: Guardrails® Suite (v7)
T
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®
Guardrails
Suite MX (v8)
December 2010
CHANNEL
SELECT
MONITOR
CHANNEL
OFF
Alaris® Products
CareFusion
San Diego, California
http://www.carefusion.com/alaris
Customer Advocacy - North America
E-Mail: CustomerFeedback@carefusion.com
Maintenance and service information support; troubleshooting.
General Contact Information
Clinical and technical feedback.
Phone: 888.876.4287
Technical Support - North America
United States:
Phone:
888.876.4287
Instrument return, service assistance, and order placement.
United States:
Phone: 888.876.4287
Canada:
Phone:
800.387.8309
Customer Care - North America
Canada:
Phone: 800.387.8309
Alaris® SpO2 Modules
Technical Service Manual
TABLE OF CONTENTS
Chapter 1 - General Information
1.1 Introduction ....................................................................................................................................................................................... 1-1
1.2 Features .............................................................................................................................................................................................. 1-1
1.3 Alarms, Errors, Messages ....................................................................................................................................................... 1-2
Chapter 2 - Checkout and Configuration
2.1 Introduction ....................................................................................................................................................................................... 2-1
2.2 New Instrument Checkout ....................................................................................................................................................... 2-1
2.3 Configuration Options and Setup - General
2.3.1 Configuration Notes .................................................................................................................................................................... 2-1
2.3.2 Factory Default Setting .............................................................................................................................................................. 2-2
2.3.3 Configuration Setup Notes
...................................................................................................................................................... 2-2
2.4 Configuration Setup .................................................................................................................................................................... 2-2
2.4.1 Access System Configuration Options ............................................................................................................................ 2-2
2.4.2 Alarm Limits ...................................................................................................................................................................................... 2-3
2.4.3 Limit Mode ......................................................................................................................................................................................... 2-4
2.4.4 Pulse Beep Volume
..................................................................................................................................................................... 2-4
2.4.5 SatSeconds Limits (8210 Series) ....................................................................................................................................... 2-5
2.4.6 Saturation Averaging Time (8220 Series) ..................................................................................................................... 2-5
................................................................................................................ 2-1
Chapter 3 - Preventive Maintenance
3.1 Introduction ....................................................................................................................................................................................... 3-1
3.2 Cleaning .............................................................................................................................................................................................. 3-1
Chapter 4 - Principles of Operation
4.1 Introduction ....................................................................................................................................................................................... 4-1
4.2 General Information .................................................................................................................................................................... 4-1
4.3 8210 Series (Nellcor
®
Technology) .................................................................................................................................... 4-1
4.4 8220 Series (Masimo® Technology) .................................................................................................................................. 4-2
Chapter 5 - Corrective Maintenance
5.1 Introduction ....................................................................................................................................................................................... 5-1
5.2 Disassembly / Reassembly .................................................................................................................................................... 5-2
5.2.1 Removing Latch Assembly and Feet ................................................................................................................................ 5-3
5.2.2 Removing IUI Connector Assemblies and Rear Case .......................................................................................... 5-4
5.2.3 Removing Frame Assembly
5.2.4 Removing Patient Connector Board Assembly .......................................................................................................... 5-6
5.2.5 Removing Logic Board Assembly
5.2.6 Removing Speaker ...................................................................................................................................................................... 5-8
5.2.7 Removing Nellcor® SpO2 Board and Power Supply Board Assemblies..................................................... 5-9
................................................................................................................................................... 5-5
...................................................................................................................................... 5-7
Alaris® SpO2 Modules
Technical Service Manual
i
TABLE OF CONTENTS
Chapter 5 - Corrective Maintenance (Continued)
5.2.8 Removing Masimo® SpO2 Board and Power Supply Board Assemblies................................................... 5-10
5.2.9 Removing IUI Bracket Strap and Bracket ..................................................................................................................... 5-11
5.2.10 Removing Display Board Assembly .............................................................................................................................. .... 5-12
5.2.11 Removing Status Indicator Lens ......................................................................................................................................... 5-13
Chapter 6 - Troubleshooting
6.1 Introduction ....................................................................................................................................................................................... 6-1
6.2 Subsystem Codes and Error Code Matrix .................................................................................................................... 6-1
Chapter 7 - Illustrated Part Breakdown
7.1 Introduction ....................................................................................................................................................................................... 7-1
7.2 Illustrations ........................................................................................................................................................................................ 7-1
7.3 Parts List
............................................................................................................................................................................................. 7-1
7.4 Ordering Parts ................................................................................................................................................................................ 7-2
List of Figures
7-1 Front Case Assembly ................................................................................................................................................................. 7-5
7-2 IUI Bracket - Frame .............................................................................................................................. ....................................... 7-6
7-3 Masimo® SpO2 Board - Power Supply Board Assembly ...................................................................................... 7-7
7-4 Nellcor® SpO2 Board - Power Supply Board Assembly ........................................................................................ 7-8
7-5 Frame Assembly - Logic Board View
7-6 Frame - Front Case Assembly .............................................................................................................................................. 7-10
7-7 IUI Assembly .................................................................................................................................................................................... 7-11
7-8 Rear Case Assembly
.................................................................................................................................................................. 7-12
7-9 Rear Label Locations .............................................................................................................................. ................................... 7-13
7-10 Display Board Assembly .............................................................................................................................. ............................ 7-14
7-11 Logic Board Assembly
............................................................................................................................................................... 7-15
7-12 Power Supply Board Assembly (8210 Series)
7-13 Power Supply Board Assembly (8220 Series)
............................................................................................................................... 7-9
........................................................................................................... 7-16
........................................................................................................... 7-17
List of Tables
1-1 Defined Terms ................................................................................................................................................................................. 1-2
5-1 Required Materials, Supplies and Tools ......................................................................................................................... 5-2
5-2 Torque Values
5-3 Level of Testing Guidelines ..................................................................................................................................................... 5-15
6-1 Technical Troubleshooting Guide ....................................................................................................................................... 6-2
6-2 Error Codes ...................................................................................................................................................................................... 6-3
7-1 Parts List............................................................................................................................................................................................. 7-3
ii
Alaris® SpO2 Modules
Technical Service Manual
................................................................................................................................................................................. 5-14
Chapter 1 – GENERAL INFORMATION
CAUTION
To avoid damaging the keypad, do not use
sharp objects (such as, pens, pencils) to activate
switches.
1.1 INTRODUCTION
This manual describes how to service the
SpO
Modules (8210 and 8220 Series). It is
2
used in conjunction with the following Alaris
System documents and software:
• PC Unit / Pump Module (
8000/8100
Series) Technical Service Manual
®
• Alaris
System Directions for Use (DFU)
• Maintenance Software and User Manual
8.1 or later)
(v
This manual is intended for personnel
experienced in analysis, troubleshooting
and repair of analog/digital microprocessorbased electronic equipment.
®
Reference the Alaris
System DFU for a
product introduction, detailed setup and
operation procedures, defi nitions (including
precaution defi nitions), specifi cations, and
other information related to the use of the
®
Alaris
System.
®
CAUTION
Any attempt to service this product by anyone
other than an authorized CareFusion Service
Representative, while the product is under
warranty, may invalidate the warranty.
If the
SpO
Module requires service while
2
under warranty, it must be serviced only by
CareFusion authorized service personnel.
Reference the "Warranty" and "Service
Information" sections in the Alaris
DFU.
1.2 FEATURES
• Functional blood oxygen saturation
percentage, pulse rate, pulse bar,
channel identification and scrolling
messages display (such as, alerts and
alarms).
• Alarm limit settings, trend data and
plethysmographic waveforms display.
• 8210 Series: SatSeconds alarm
Management Technology, to allow
monitoring of
%SpO
below selected low
2
alarm limit for a period of time before an
audible alarm sounds.
®
System
Alaris® SpO2 Modules
Technical Service Manual
1-1
GENERAL INFORMATION
1.2 FEATURES (Continued)
• 8220 Series: Signal Extraction
Technology
®
(SET®) for accurate readings
under extreme conditions (such as, low
perfusion and motion).
®
Reference the Alaris
System DFU for a list
of features and definitions.
Table 1-1. Defined Terms
The following table identifies the defined terms used throughout this document for certain trademarked
products and product features.
Product / Feature Defined Term
Alaris® PC point-of-care unit PC Unit
Alaris® PC unit PC Unit
®
Alaris
Pump module Pump Module
Alaris® SpO2 module SpO2 Module
Guardrails® data set Data Set
1.3 ALARMS AND MESSAGES
Alarm messages are displayed on the
scrolling Message Display bar. Reference
®
the Alaris
System DFU for detailed
information.
An audio alarm and the Alarm Status
Indicator flash red when an alarm limit is met
or exceeded. All alarms can be temporarily
silenced by pressing the
SILENCE key on
the PC Unit.
1-2
Alaris® SpO2 Modules
Technical Service Manual
Chapter 2 – CHECKOUT AND CONFIGURATION
CAUTION
Should an instrument be dropped or severely
jarred, remove it from use immediately. It should
be thoroughly tested and inspected by qualified
service personnel to ensure proper function prior
to reuse.
2.1 INTRODUCTION
SpO
This chapter describes initial
Module
2
setup and configuration. Due to product
changes over time, configurations described
in this chapter may differ from the instrument
being serviced.
2.2 NEW INSTRUMENT CHECKOUT
Prior to placing a new instrument in use,
perform a check-in procedure using the
Maintenance Software.
When powering up the instrument, verify
the instrument beeps and all display
segments flash. This confirms that the
instrument has performed its self test and
is operating correctly. During operation, the
instrument continually performs a self test,
and alarms and displays a message if it
detects an internal malfunction.
Contact CareFusion authorized service
personnel if the instrument has physical
damage, fails to satisfactorily pass the
startup sequence, fails a self test, or
continues to alarm.
LED
2.3 CONFIGURATION OPTIONS AND
SETUP - GENERAL
®
Reference the Alaris
System DFU for the
following information:
• System Settings
SpO
•
Module Settings
2
2.3.1 Configuration Notes
• Changes to factory default values are
retained after a power cycle.
• If Factory Default is Yes, then all
configuration settings are set to their
factory default.
Alaris® SpO2 Modules
Technical Service Manual
2-1
CHECKOUT AND CONFIGURATION
2.3 CONFIGURATION OPTIONS AND
SETUP - GENERAL (Continued)
2.3.1 Configuration Notes (Continued)
• If Factory Default is No, then one or
more of the configuration settings has
been changed. If desired, Factory
Default can be selected and set to Yes,
which will set all configuration settings to
their factory default.
2.3.2 Factory Default Setting
To allow changes to be made to System
Configuration parameters:
1. Hold
OPTIONS key at power up.
System Configuration - Module
Factory default:
Shared Infusion Settings
PC Unit
Pump Module
SPO2 Module
Yes
2.3.3 Configuration Setup Notes
• Pressing
EXIT soft key while in a
System Configuration - Module screen
immediately powers system down, with
no "Powering Down" display.
• Pressing
Config -
EXIT soft key while in a System
SPO2 screen returns display to
main System Configuration - Module
screen.
• Pressing
CONFIRM soft key while in a
System Configuration option screen:
- accepts existing setting or setting
change
- displays next option setting screen (if
applicable) or returns display to System
Config - SPO2 screen
• Pressing PC Unit’s CANCEL key while in
a System Configuration option screen:
- leaves setting unchanged
- returns display to System Config - SPO2
screen
>Select an Option
or EXIT
EXIT
PAGE
DOWN
2. Press Factory default soft key.
3. Press No soft key.
System Configuration
Factory Default
Settings?
Selection of Yes sets all
System Configuration
parameters to the factory
default setting.
EXIT
4. To accept change, press
Yes
No
EXIT soft key.
2.4 CONFIGURATION SETUP
To change an option setting, ensure the
Factory default setting is No.
2.4.1 Access System Configuration Options
1. Hold
OPTIONS key at power up.
System Configuration - Module
Factory default:
Shared Infusion Settings
PC Unit
Pump Module
SPO2 Module
>Select an Option
or EXIT
EXIT
No
PAGE
DOWN
2-2
Alaris® SpO2 Modules
Technical Service Manual
CHECKOUT AND CONFIGURATION
2.4 CONFIGURATION SETUP (Continued)
2.4.1 Access System Configuration Options
(Continued)
2. Press SPO2 Module soft key. To view
additional options, press
PAGE DOWN
soft key.
System Config - SPO2 1 of 2
Adult alarm limits
Limits Mode:
Neonatal alarm limits
Pulse beep volume:
SatSeconds limits:
>Select an Option
or EXIT
EXIT
System Config - SPO2 2 of 2
Sat Averaging time: 8
Adult
No
Off
10
PAGE
DOWN
No
System Configuration - SPO2
Adult alarm limits
%SPO2
HIGH
%SPO2
LOW
PULSE
HIGH
PULSE
LOW
>Select Parameter Limit
Off
90
150
50
CONFIRM
2. To change an alarm limit, press soft key
next to parameter to be changed.
System Configuration - SPO2
Adult alarm limits
%SPO2
HIGH
%SPO2
LOW
PULSE
HIGH
PULSE
LOW
>Enter High %SPO2 Limit
Off
90
150
50
CONFIRM
>Select an Option
or EXIT
PAG E
EXIT
UP
2.4.2 Alarm Limits
The following displays represent the Adult
alarm limits but the same procedure is
used for configuring the Neonatal alarm
limits.
1. After accessing System Config -
options display, press Adult alarm
limits or Neonatal alarm limits soft
key.
SPO2
3. Enter a numeric value for selected
alarm limit. Adult
%SPO2 HIGH limit
can be Off or a numeric value. Numeric
values can be entered using keypad
and keys. Prompt changes
or
to >Press
ENTER to CONFIRM after
a valid value has been highlighted for
3 seconds.
System Configuration - SPO2
Adult alarm limits
%SPO2
HIGH
%SPO2
LOW
PULSE
HIGH
PULSE
LOW
>Press CONFIRM to Apply
Changes
_98
90
150
50
Off
CONFIRM
Alaris® SpO2 Modules
Technical Service Manual
2-3
CHECKOUT AND CONFIGURATION
2.4 CONFIGURATION SETUP (Continued)
2.4.2 Alarm Limits (Continued)
4. To accept change, press ENTER key.
• Display highlights next limit and
prompts for an entry.
5. To change another alarm limit, press
soft key for that parameter and make
necessary change.
System Configuration - SPO2
Adult alarm limits
%SPO2
HIGH
%SPO2
LOW
PULSE
HIGH
PULSE
LOW
>Enter High Pulse Limit
6. To accept change(s), press
98
90
150
50
CONFIRM
CONFIRM
soft key.
2. Select Adult or Neonatal by pressing
applicable soft key.
• Following display represents
Neonatal alarm limits but same
procedure is used for confi guring
Adult alarm limits.
System Configuration - SPO2
Neonatal alarm limits
%SPO2
HIGH
%SPO2
LOW
PULSE
HIGH
PULSE
LOW
>Select Parameter Limit
88
70
120
40
CONFIRM
3. To change an alarm limit, see "Alarm
Limits" section.
OR
To accept settings, press CONFIRM soft
key.
2.4.3 Limit Mode
1. After accessing System Config -
options display, press Limits Mode soft
key.
• Limit Mode cannot be changed
if a Profi le is being used for
programming.
System Configuration - SPO2
Limit Mode Setup
Adult
Allows selection
between the
adult and neonatal
modes
of operation.
Neonatal
SPO2
2.4.4 Pulse Beep Volume
1. After accessing System Config -
options display, press Pulse beep
volume soft key
• Following display refl ects that Pulse
Beep Volume is Off. To display
volume options, press Louder soft
key.
System Configuration - SPO2
Pulse Beep
Volume
Softer
>Press CONFIRM
Off
Louder
CONFIRM
SPO2
2-4
Alaris® SpO2 Modules
Technical Service Manual
CHECKOUT AND CONFIGURATION
2.4 CONFIGURATION SETUP (Continued)
2.4.4 Pulse Beep Volume (Continued)
2. To increase volume, press Louder
soft key until desired volume level is
attained. To turn off pulse beep entirely,
press Off soft key.
• Selectable volume levels are
3. Audio sounds for 1 cycle.
and
System Configuration - SPO2
Pulse Beep
Volume
Softer
> Press CONFIRM
Off
Louder
CONFIRM
1, 2
3. To accept setting, press CONFIRM soft
key.
2.4.5 SatSeconds Limits (
1. After accessing System Config -
8210 Series)
SPO2
options display, press SatSeconds
limits soft key.
• Selectable options are Off, or
50 and 100 seconds.
3. To accept settings, press
CONFIRM soft
key.
2.4.6 Saturation Averaging Time (
8220 Series)
1. After accessing System Config -
options display, page
2, press Sat.
Averaging time soft key.
System Configuration - SPO2
Masimo Saturation Averaging
Time
8 Seconds
Determines the averaging time
for the displayed data.
>Press CONFIRM
Increase
Decrease
CONFIRM
2. To change Saturation Averaging Time,
press either Increase or Decrease soft
key.
• Selectable options are
12, 14 and 16 seconds. Fast sat
is enabled when
2, 4, 8, 10,
2 or 4 seconds is
selected.
10, 25,
SPO2
System Configuration - SPO2
Nellcor SatSeconds Limits
SPO2
25
Seconds
>Press Increase, Decrease
or Off
Increase
Decrease
Off
CONFIRM
2. To change SatSeconds Limits, press
either Increase or Decrease soft key.
To turn off SatSeconds Limits, press
Off soft key.
3. To accept settings, press
key.
Alaris® SpO2 Modules
Technical Service Manual
CONFIRM soft
2-5
CHECKOUT AND CONFIGURATION
THIS PAGE
INTENTIONALLY
LEFT BLANK
2-6
Alaris® SpO2 Modules
Technical Service Manual
Chapter 3 – PREVENTIVE MAINTENANCE
WARNING
Failure to perform regular and preventive
maintenance inspections may result in improper
instrument operation.
3.1 INTRODUCTION
Perform regular and preventive maintenance
inspections to ensure that the
SpO
remains in good operating condition:
• Perform regular inspections before each
use.
• Perform preventive maintenance
inspections once a year.
Use the Maintenance Software to perform
calibration and preventive maintenance.
These requirements and guidelines are
intended to complement the intent of
the Joint Commission on Accreditation
of Healthcare Organizations (
JCAHO)
requirements.
3.2 CLEANING
®
Reference the Alaris
System DFU.
Module
2
Alaris® SpO2 Modules
Technical Service Manual
3-1
PREVENTIVE MAINTENANCE
THIS PAGE
INTENTIONALLY
LEFT BLANK
3-2
Alaris® SpO2 Modules
Technical Service Manual
Chapter 4 – PRINCIPLES OF OPERATION
4.1 INTRODUCTION
This chapter describes the
SpO
Module
2
principles of operation.
Reference the PC Unit / Pump Module
8000/8100 Series) Technical Service Manual
(
for Alaris
®
System principles of operation.
4.2 GENERAL INFORMATION
SpO
Module operation is based
2
on the principles of pulse oximetry.
Oxyhemoglobin and deoxyhemoglobin differ
in their absorption of red and infrared light
(spectrophotometry). The volume of arterial
blood in tissue and the light absorbed
by the blood changes during the pulse
(plethysmography).
Because oxyhemoglobin and
deoxyhemoglobin differ in light absorption,
the amount of red and infrared light
absorbed by blood is related to hemoglobin
oxygen saturation.
4.3 8210 Series (Nellcor Technology)
SpO
A pulse oximeter determines
by
2
passing red and infrared light into an
arteriolar bed and measuring changes in
light absorption during the pulsatile cycle.
Red and infrared low-voltage light-emitting
diodes (
LED) in the oximetry sensor serve as
light sources; a photo diode serves as the
photo detector.
To identify the oxygen saturation of arterial
hemoglobin, the monitor uses the pulsatile
nature of arterial flow. During systole,
a new pulse of arterial blood enters the
vascular bed, and blood volume and light
absorption increase. During diastole, blood
volume and light absorption reach their
SpO
lowest point. The
SpO
measurements on the difference
2
Module bases its
2
between maximum and minimum absorption
(measurements at systole and diastole).
Alaris® SpO2 Modules
Technical Service Manual
4-1
PRINCIPLES OF OPERATION
4.3 8210 series (Nellcor Technology)
(Continued)
By doing so, it focuses on light absorption
by pulsatile arterial blood, eliminating the
effects of nonpulsatile absorbers (such as,
venous blood, tissue and bone).
Because light absorption by hemoglobin
is wavelength dependent and the mean
wavelength of
LEDs varies, an oximeter
must know the mean wavelength of the
sensor’s red
SpO
. During monitoring, the instrument’s
2
LED to accurately measure
software selects coefficients that are
appropriate for the wavelength of that
individual sensor’s red
LED. Those
coefficients are then used to determine
SpO
.
2
To compensate for differences in tissue
thickness, the light intensity of the sensor’s
LEDs is adjusted automatically.
The
SpO
Module measures functional
2
saturation (oxygenated hemoglobin
expressed as a percentage of the
hemoglobin that can transport oxygen).
It does not detect significant amounts
of dysfunctional hemoglobin (such as,
carboxyhemoglobin or methemoglobin). In
contrast, hemoximeters (such as,
IL482)
report fractional saturation (oxygenated
hemoglobin expressed as a percentage
of all measured hemoglobin, including
measured dysfunctional hemoglobin).
To compare functional saturation
measurements to those from an instrument
that measures fractional saturation,
fractional measurements must be converted
as follows:
functional saturation =
fractional saturation
100 - (%carboxyhemoglobin + %methemoglobin)
When saturation is calculated from a
blood gas partial pressure of oxygen
x 100
PO
), the calculated value may differ
(
2
SpO
from the
measurement of the SpO2
2
Module. This usually occurs because the
calculated saturation was not appropriately
corrected for the effects of variables that
PO
shift the relationship between
and
2
pH, temperature, the partial pressure
PCO
of carbon dioxide (
), 2,3-DPG, and
2
fetal hemoglobin. To compare functional
saturation measurements to those from
an instrument that measures fractional
saturation, fractional measurements must be
converted as follows:
Oxyhemoglobin Dissociation Curve
pH
100
¯
Temperature
¯
PCO
2
¯
2,3-DPG
Fetal Hb
50
Saturation (%)
0
¬
®
pH
¯
Temperature
¯
PCO
2
2,3-DPG
¯
50 100
PO (mmHg)
2
4.4 8220 Series (Masimo Technology)
SpO
The
Signal Extraction Technology
Module uses the Masimo®
2
®
(SET®) to
decompose the red and infrared pulsatile
absorbance signal into an arterial signal plus
a noise component. Its value is used to find
SpO
the
equation in the Masimo
saturation in an empirically derived
2
®
SET® software. The
values in an internal look-up table are based
on human blood studies against a laboratory
co-oximeter on healthy adult volunteers in
induced hypoxia states during motion and
nonmotion conditions.
4-2
Alaris® SpO2 Modules
Technical Service Manual
Chapter 5 – CORRECTIVE MAINTENANCE
WARNING
Disconnect the SpO2 Module from the Alaris®
System prior to performing maintenance.
The instrument case should only be opened
by qualified personnel using proper grounding
techniques.
CAUTION
CMOS devices are sensitive to static electrical
charges and may be damaged during repair if the
repair activity is not performed in an electrostatic
discharge (
approved
ESD) protected environment using
ESD protective procedures, including
personnel grounding.
5.1 INTRODUCTION
This chapter describes how to disassemble
SpO
and reassemble the
The circuit boards used in the
Module.
2
SpO
are fitted with surface mount devices and
are not field repairable. Return circuit
boards to an authorized CareFusion Service
Center for repair. Attempting circuit board
repairs voids all warranties.
For replacement part information, see the
"Illustrated Parts Breakdown" chapter.
Following any level of maintenance, perform
the applicable tests (see "Level of Testing
Guidelines" table).
Due to product changes over time,
components/assemblies illustrated in this
chapter may differ from the instrument being
serviced.
Module
2
Alaris® SpO2 Modules
Technical Service Manual
5-1
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