Smiths Medical BCI 3304 User manual

BCI® 3304 Oximeter
Service Manual
-English
Catalog Number 1858
Version 7, April 2008
© 2008 Smiths Medical family of companies. All rights reserved.
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Table of Contents
3304 Service Manual i
Revision History ................................................................v
Warranty & Service Information.....................................vii
Proprietary Notice ............................................................................................... vii
Warranty ................................................................................................................. vii
Limited Warranty......................................................................................... vii
Disclaimer of Warranties.......................................................................... viii
Conditions of Warranty............................................................................ viii
Limitation of Remedies............................................................................ viii
Warranty Procedure .....................................................................................ix
CE Notice ..................................................................................................................ix
Chapter 1: Introduction ................................................ 1-1
About this Manual..............................................................................................1-1
Symbol Denitions.............................................................................................1-1
Warnings................................................................................................................1-3
Cautions.................................................................................................................1-8
Notes.......................................................................................................................1-8
Chapter 2: Oximeter Circuit Description ..................... 2-1
Functional Structure..........................................................................................2-1
Battery Charger ...................................................................................................2-1
General Description..................................................................................2-1
Oximeter On/O Control.................................................................................2-2
System Power Supply........................................................................................2-2
Microprocessor Circuit......................................................................................2-2
Reset Circuit.................................................................................................2-3
Memory and I/O Decoding ....................................................................2-3
Dual microprocessor operation............................................................2-3
Interface Circuit...................................................................................................2-4
Addressable Latch and Speaker Output............................................2-4
Table of Contents

Table of Contents
ii 3304 Service Manual
Input buer..................................................................................................2-4
Synchronous Serial Port ..........................................................................2-4
Asynchronous Serial Port........................................................................2-4
RS-232 Isolation Interface.......................................................................2-4
A/D Converter......................................................................................................2-5
LED Drive ...............................................................................................................2-5
Signal Processing................................................................................................2-6
Display Board .......................................................................................................2-6
Signal Dictionary ................................................................................................2-7
Oximeter Board ..........................................................................................2-7
Display Board .................................................................................................... 2-10
Test Equipment and Tools Required......................................................... 2-10
Voltage Test Points .......................................................................................... 2-11
Waveform Test Points.....................................................................................2-11
Appendix .................................................................. App-1
Parts Lists.........................................................................................................App-1

Table of Contents
3304 Service Manual iii
The product described is covered by one or more of the following: U.S.
Patent No. 5,615,091 and 5,558,096.
BCI and the Smiths design mark are trademarks of the Smiths Medical
family of companies. The symbol ®indicates the trademark is
registered in the U.S. Patent and Trademark Oce and certain other
countries. All other names and marks mentioned are the trade names,
trademarks or service marks of their respective owners.

Table of Contents
iv 3304 Service Manual
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Revision History
3304 Service Manual v
REVISION DATE
Rev.7 April, 2008
CHANGES
Added design frame, BCI lozenge and Smiths Medical logo to•
front cover. Deleted Smiths Medical logo from back cover.
Added the Smiths design mark to trademark statement.•
Updated Warranty section.•
Added the Australian Representative to Warranty section and•
back cover.
Updated symbol chart.•
Updated warnings, cautions and notes. Changed some•
cautions and notes to warnings.
Updated Appendix for Assembly drawings and Schematics.•
REVISION DATE
Rev.6 June, 2006
CHANGES
Updated line art.•
Updated copyright statement on front cover.•
Added trademark and patent information to table of contents.•
Updated company name.•
Updated warranty section.•
Moved information from Chapter 3 to Chapter 1.•
Added symbol chart to Chapter 1.•
Added photodynamic therapy warning.•
Added this Revision History page.•
Dierent page numbering scheme for Appendix drawings.•
Revision History

Revision History
vi 3304 Service Manual
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Warranty & Service Information
3304 Service Manual vii
Proprietary Notice
Information contained in this document is copyrighted by Smiths
Medical PM, Inc. and may not be duplicated in full or part by any person
without prior written approval of Smiths Medical PM, Inc. Its purpose
is to provide the user with adequately detailed documentation to
eciently install, operate, maintain and order spare parts for the device
supplied. All information contained in this document is believed to be
current and accurate as of the date of publication or revision, but does
not constitute a warranty.
Warranty
Limited Warranty
Smiths Medical PM, Inc. (“Seller”) warrants to the original purchaser
that the Product, not including accessories, shall be free from defects
in material and workmanship under normal use, if used in accordance
with its labeling, for two years from the date of shipment to the original
purchaser.
Seller warrants to the original purchaser that the reusable oximeter
sensors supplied as accessories, shall be free from defects in materials
and workmanship under normal use, if used in accordance with
its labeling, for one year from the date of shipment to the original
purchaser (USA only).
Warranty & Service Information

Warranty & Service Information
viii 3304 Service Manual
Disclaimer of Warranties
THE FOREGOING EXPRESS WARRANTY, AS CONDITIONED AND
LIMITED, IS IN LIEU OF AND EXCLUDES ALL OTHER WARRANTIES
WHETHER EXPRESS OR IMPLIED, BY OPERATION OF LAW OR
OTHERWISE, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE.
Seller disclaims responsibility of the suitability of the Product for any
particular medical treatment or for any medical complications resulting
from the use of the Product. This disclaimer is dictated by the many
elements which are beyond Seller’s control, such as diagnosis of patient,
conditions under which the Product may be used, handling of the
Product after it leaves Seller’s possession, execution of recommended
instructions for use and others.
Conditions of Warranty
This warranty is void if the Product has been altered, misused, damaged
by neglect or accident, not properly maintained or recharged, or
repaired by persons not authorized by Seller. Misuse includes, but is
not limited to, use not in compliance with the labeling or use with
accessories not manufactured by Seller. This warranty does not cover
normal wear and tear and maintenance items.
Limitation of Remedies
The original purchaser’s exclusive remedy shall be, at Seller’s sole
option, the repair or replacement of the Product. THIS IS THE
EXCLUSIVE REMEDY. In no event will Seller’s liability arising out of
any cause whatsoever (whether such cause is based on contract,
negligence, strict liability, tort or otherwise) exceed the price
of the Product and in no event shall Seller be responsible for
consequential, incidental, or special damages of any kind or nature
whatsoever, including but not limited to, lost business, revenues,
and prots.

Warranty & Service Information
3304 Service Manual ix
Warranty Procedure
To obtain warranty service in the USA, you must request a Customer
Service Report (CSR) number from Technical Service. Reference the CSR
number when returning your Product, freight and insurance prepaid, to:
Smiths Medical PM, Inc.
N7W22025 Johnson Drive
Waukesha, WI 53186-1856
Phone: [phone]
Fax: [phone]
Toll Free: [phone] (USA Only)
Seller will not be responsible for unauthorized returns or for loss or
damage to the Product during the return shipment. The repaired or
replaced Product will be shipped, freight prepaid, to Purchaser.
To obtain warranty information outside of the USA, contact your local
distributor.
Keep all original packing material, including foam inserts. If you need
to ship the device, use only the original packaging material, including
inserts. Box and inserts should be in original condition. If original
shipping material in good condition is not available, it should be
purchased from Smiths Medical PM, Inc.
Damages occurred in transit in other than original shipping containers
are the responsibility of the shipper. All costs incurred returning devices
for repair are the responsibility of the shipper.
CE Notice
Marking by the symbol 2indicates compliance of this device to
the Medical Device Directive 93/42/EEC.
Authorized Representative (as dened by the Medical Device Directive):
Smiths Medical International Ltd.
Colonial Way, Watford, Herts,
WD24 4LG, UK
Phone: [phone]
Fax: [phone]
Australian Representative:
Smiths Medical Australasia Pty. Ltd.
61 Brandl Street, Eight Mile Plains,
QLD 4113, Australia
Tel: [phone]

Warranty & Service Information
x 3304 Service Manual
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Chapter 1: Introduction
3304 Service Manual 1-1
About this Manual
This manual contains circuit descriptions, voltage and waveform test
points, detailed parts lists, and circuit diagrams for the oximeter. It is
intended for persons trained in service, maintenance, and repair of
modern medical equipment. Thorough knowledge of this equipment’s
operation is required before attempting to repair this equipment.
The remainder of the manual is divided into these sections:
• Oximeter Circuit Description. Contains circuit descriptions,
voltage test points, and waveform test points for the oximeter
and display board.
• Parts Lists & Circuit Diagrams. Contains detailed parts lists
and circuit diagrams for the oximeter.
Symbol Denitions
SYMBOL DEFINITION
6Caution: Federal (U.S.A.) law restricts this device to sale by or on
the order of a physician.
pType CF equipment
SType B Equipment
gAttention, see instructions for use.
7Refer servicing to qualied service personnel.
7Do not reuse. One use on one patient.
%SpO2 Percent Oxygen Saturation
pPulse Rate LED (beats per minute)
LOn/O
KPulse Volume
IAlarm Volume
Chapter 1: Introduction

Chapter 1: Introduction
1-2 3304 Service Manual
SYMBOL DEFINITION
no Up and Down Arrows
HAlarm Select
JID/CLEAR
KMoisture Sensitive
1Non AP Device
DOutput Voltage
EInput Voltage
FPrinter output
GDirect Current
0Speaker
<Catalog Number
JDate of Manufacture
Z
Collect
Separately
Disposal (EU Countries)
Under the Waste Electrical and Electronic Equipment (WEEE)
Directive 2006/96/EC and implementing regulations, all devices
and service items within the scope of the Directive purchased
new after August 13, 2005 must be sent for recycling when
ultimately becoming waste. Devices and items must not be
disposed of with general waste.
If purchased before that date, they may also be sent for
recycling if being replaced on a one-for-one, like-for-like basis
(this varies depending on the country). Recycling instructions
to customers using Smiths Medical products are published on
the internet at:
http://www.smiths-medical.com/recycle

Chapter 1: Introduction
3304 Service Manual 1-3
SYMBOL DEFINITION
Y
Disposal (other countries)
When disposing of this device, its batteries or any of
its accessories, ensure that any negative impact on the
environment is minimized. Contact your local waste disposal
service and use local recycling or disposal schemes. Separate
any other parts of the equipment where arrangements can be
made for their recovery; either by recycling or energy recovery.
The main batteries are potentially harmful and will require
separate disposal according to manufacturer’s instructions or
local regulations.
Note: If applicable, EU, national or local regulations
concerning waste disposal must take precedence over the
above advice.
KEYWORD DEFINITION
WARNING! Tells you about something that could hurt the patient
CAUTION! Tells you about something that could damage the monitor
NOTE! Tells you other important information
Warnings
WARNING! Do not use this device in the presence of ammable
anesthetics.
WARNING! Do not use this device in the presence of magnetic
resonance imaging (MR or MRI) equipment.
WARNING! Operation of this device may be adversely aected
in the presence of conducted transients or strong
electromagnetic (EM) or radiofrequency (RF) sources,
such as electrosurgery and electrocautery equipment,
x-rays, and high intensity infrared radiation.
WARNING! Operation of this device may be adversely aected in
the presence of computed tomograph (CT) equipment.
WARNING! Any monitor that has been dropped or damaged
should be inspected by qualied service personnel,
prior to use, to insure proper operation.

Chapter 1: Introduction
1-4 3304 Service Manual
WARNING! If the accuracy of any measurement is in question,
verify the patient’s vital sign (s) by an alternative
method and then check the monitor for proper
functioning.
WARNING! This device must be used in conjunction with clinical
signs and symptoms. This device is only intended to be
an adjunct in patient assessment.
WARNING! This device is intended for use by persons trained
in professional health care. The operator must be
thoroughly familiar with the information in this
manual before using the device.
WARNING! It is the operator’s responsibility to set alarm limits
appropriately for each individual patient.
WARNING! Prolonged use or the patient’s condition may require
changing the sensor site periodically. Change sensor
site and check skin integrity, circulatory status, and
correct alignment at least every 4 hours.
WARNING! When attaching sensors with Microfoam®tape, do
not stretch the tape or attach the tape too tightly. Tape
applied too tightly may cause inaccurate readings and
blisters on the patient’s skin (lack of skin respiration,
not heat, causes the blisters).
WARNING! Connect the Wall Mount Charger to grounded, three-
wire outlet. Failure to comply may compromise patient
isolation.
WARNING! Patient safety can be compromised by the use of a
power supply not supplied by Smiths Medical PM, Inc.
Use only the power supply included with your monitor,
or approved by Smiths Medical PM, Inc.
WARNING! Verify the functionality of any remote alarm system
connected to this monitor before leaving the patient
unattended.
WARNING! Use only SpO2sensors supplied with, or specically
intended for use with, this device.

Chapter 1: Introduction
3304 Service Manual 1-5
WARNING! SpO2measurements may be adversely aected in the
presence of high ambient light. Shield the sensor area
(with a surgical towel, for example) if necessary.
WARNING! Dyes introduced into the bloodstream, such as
methylene blue, indocyanine green, indigo carmine,
uorescein, and patent blue V (PBV) may adversely
aect the accuracy of the SpO2reading.
WARNING! Any condition that restricts blood ow, such as use of
a blood pressure cu or extremes in systemic vascular
resistance, may cause an inability to determine
accurate pulse rate and SpO2readings.
WARNING! Optical cross-talk can occur when two or more sensors
are placed in close proximity. It can be eliminated by
covering each site with an opaque material.
WARNING! Remove ngernail polish or false ngernails before
applying SpO2sensors. Fingernail polish or false
ngernails may cause inaccurate SpO2readings.
WARNING! Signicant levels of dysfunctional hemoglobins,
such as carboxyhemoglobin (with CO-poisoning) or
methemoglobin (with sulfonamide therapy), will aect
the accuracy of the SpO2measurement.
WARNING! Tissue damage may result from overexposure to
sensor light during photodynamic therapy with
agents such as verteporphin, pormer sodium, and
metatetrahydroxyphenylchlorin (mTHPC). Change the
sensor site at least every hour and observe for signs
of tissue damage. More frequent sensor site changes/
inspections may de indicated depending upon the
photodynamic agent used, agent dose, skin condition,
total exposure time or other factors. Use multiple
sensor sites.

Chapter 1: Introduction
1-6 3304 Service Manual
WARNING! When connecting this monitor to any instrument,
verify proper operation before clinical use. Refer to
the instrument’s user manual for full instructions.
Accessory equipment connected to the monitor’s data
interface must be certied according to the respective
IEC standards, i.e., IEC 60950 for data processing
equipment or IEC 601-1 for electromedical equipment.
All combinations of equipment must be in compliance
with IEC 601-1 systems requirements. Anyone
connecting additional equipment to the signal input
port or the signal output port congures a medical
system, and therefore is responsible that the system
complies with the requirements of the system standard
IEC 601-1.
WARNING! IEC 60950 approved equipment must be placed outside
the “patient environment.”The patient environment is
dened as an area 1.5 m (4.92 feet) from the patient.
Figure 1.1: Patient Environment
WARNING! Disconnect the AC power supply from the outlet before
disconnecting it from the monitor. Leaving the AC
power supply connected to an AC power outlet without
being connected to the monitor may result in a safety
hazard.
WARNING! Do not allow any moisture to touch the AC power
supply connectors or a safety hazard may result.
Ensure that hands are thoroughly dry before handling
the AC power supply.
R 1.5 m (4.9 ft.)

Chapter 1: Introduction
3304 Service Manual 1-7
WARNING! Do not place the monitor in the patient’s bed or crib.
Do not place the monitor on the oor.
WARNING! Failure to place the monitor away from the patient
may allow the patient to turn o, reset, or damage the
monitor, possibly resulting in the patient not being
monitored. Make sure the patient cannot reach the
monitor from their bed or crib.
WARNING! Failure to carefully route the cable from the sensor
to the monitor may allow the patient to become
entangled in the cable, possibly resulting in patient
strangulation. Route the cable in a way that will
prevent the patient from becoming entangled in the
cable. If necessary, use tape to secure the cable.
WARNING! If there is a risk of the AC power supply becoming
disconnected from the monitor during use, secure
the cord to the monitor several inches from the
connection.
WARNING! Under certain clinical conditions, pulse oximeters may
display dashes if unable to display SpO2and/or pulse
rate values. Under these conditions, pulse oximeters
may also display erroneous values. These conditions
include, but are not limited to: patient motion, low
perfusion, cardiac arrhythmias, hi or low pulse rates or
a combination of the above conditions. Failure of the
clinician to recognize the eects of these conditions on
pulse oximeter readings may result in patient injury.
WARNING! Verify that all LEDs (light emitting diodes) on the
display light up upon startup of the device.

Chapter 1: Introduction
1-8 3304 Service Manual
Cautions
CAUTION! The monitor is equipped with an internal rechargeable
battery. Do not attempt to remove or replace the
internal rechargeable battery. Refer servicing to an
authorized repair center.
CAUTION! Failure to charge the monitor while the monitor is not
being used may shorten the battery life. Charge the
monitor while the monitor is not being used to ensure
the longest battery life.
CAUTION! Do not autoclave, ethylene oxide sterilize, or immerse
the sensors in liquid.
CAUTION! Do not allow water or any other liquid to spill onto the
monitor. Do not autoclave, ethylene oxide sterilize, or
immerse the monitor in liquid. Evidence that liquid has
been allowed to enter the monitor voids the warranty.
CAUTION! Chemicals used in some cleaning agents may cause
brittleness of plastic parts. Follow cleaning instructions
in this manual.
CAUTION! Pressing front panel keys with sharp or pointed
instruments may permanently damage the keypad.
Press front panel keys only with your nger.
Notes
NOTE! If the digital outputs are enabled and a low battery
condition is present, the digital outputs will be activated.
NOTE! “SpO2averaging” means the number of pulse beats over
which the SpO2value is averaged;“pulse averaging”
means the number of seconds over which the pulse value is
averaged.
NOTE! Increasing or decreasing the averaging setting has no
eect on the data update rate.