BCI 1884 User manual

Pulse Oximeter
Operation Manual
Catalog Number 1884
Version 7, March 2003
Copyright BCI, Inc. - 2003

Table of Contents
Oximeter Operation Manual i
Clinician’s Operation Manual
Warranty & Service Information ................................................................................................... iii
Proprietary Notice ....................................................................................................................... iii
WARRANTY ................................................................................................................................ iii
Limited Warranty ........................................................................................................................ iii
Disclaimer of Warranties ............................................................................................................ iii
Conditions of Warranty............................................................................................................... iii
Limitation of Remedies ............................................................................................................... iii
Warranty Procedure .................................................................................................................... iv
CE Notice....................................................................................................................................... iv
Warnings, Cautions, & Notes ..........................................................................................................v
Symbol Definitions ..........................................................................................................................v
Warnings ..........................................................................................................................................v
Cautions ......................................................................................................................................... vi
Notes .............................................................................................................................................. vi
Chapter 1: Introduction 1-1
About the Manual......................................................................................................................... 1-1
Theory of Operation..................................................................................................................... 1-1
Chapter 2: Intended Use and Monitor Features 2-1
Intended Use ................................................................................................................................ 2-1
Monitor Features .......................................................................................................................... 2-1
Chapter 3: Controls & Features 3-1
Monitor Front Panel ..................................................................................................................... 3-1
Sensor/Printer Connector .......................................................................................................... 3-1
SpO2 Numeric Display .............................................................................................................. 3-1
Pulse Rate Numeric Display......................................................................................................3-1
Pulse Strength Bar Graph.......................................................................................................... 3-1
Low Battery Indicator ............................................................................................................... 3-1
xON OFF Key......................................................................................................................... 3-2
FPRINT Key ........................................................................................................................... 3-2
8Speaker Silence Key............................................................................................................. 3-2
Chapter 4: Operating Instructions 4-1
Unpacking the Monitor ................................................................................................................ 4-1
Install the Batteries....................................................................................................................... 4-1
Attaching the Sensor to the Patient .............................................................................................. 4-2
Choosing the Sensor.................................................................................................................. 4-2
Care and Handling of the Sensor............................................................................................... 4-3
Checking the Sensor and Oximetry Cable ................................................................................ 4-4
Cleaning or Disinfecting the Sensors ........................................................................................ 4-4
Turning On the Monitor............................................................................................................... 4-5
Enable/Disable Pulse Beep........................................................................................................ 4-5
Low Battery Indicator .................................................................................................................. 4-6
Turning Off the Monitor .............................................................................................................. 4-6
Automatic Power Down............................................................................................................4-6
Checking the Monitor’s Performance .......................................................................................... 4-6
Chapter 5: Patient Numbers & Trend Data 5-1
Description................................................................................................................................... 5-1
Manually Incrementing the Patient Number ................................................................................ 5-1
Clearing Trend Data..................................................................................................................... 5-1

Table of Contents
ii Oximeter Operation Manual
Chapter 6: Printer 6-1
Description................................................................................................................................... 6-1
What You’ll Need for Printing .................................................................................................... 6-1
Trend Printouts ............................................................................................................................ 6-2
Collecting Trend Data............................................................................................................... 6-2
Data log........................................................................................................................................ 6-2
Paper Feed................................................................................................................................. 6-3
Chapter 7: PC Communication Setup 7-1
Description................................................................................................................................... 7-1
PC Communication Setup............................................................................................................ 7-1
Chapter 8: Maintenance 8-1
Schedule of Maintenance............................................................................................................. 8-1
Storage ......................................................................................................................................... 8-1
Chapter 9: Troubleshooting 9-1
EMI Interference.......................................................................................................................... 9-2
Chapter 10: Optional Supplies & Accessories 10-1
Ordering Information:................................................................................................................ 10-1
Chapter 11: Specifications 11-1
Equipment Classification ........................................................................................................... 11-1
Displays, Indicators, & Keys ..................................................................................................... 11-1
SpO2........................................................................................................................................... 11-1
Pulse Rate .................................................................................................................................. 11-2
Optional Printer ......................................................................................................................... 11-2
Power Requirements .................................................................................................................. 11-2
Battery Life................................................................................................................................ 11-2
Dimensions ................................................................................................................................ 11-2
Environmental Specifications ................................................................................................... 11-2

Warranty & Service Information
Oximeter Operation Manual iii
Warranty & Service Information
Proprietary Notice
Information contained in this document is copyrighted by BCI, Inc. and may not be duplicated
in full or part by any person without prior written approval of BCI, Inc. Its purpose is to
provide the user with adequately detailed documentation to efficiently install, operate,
maintain and order spare parts for the device supplied. Every effort has been made to keep the
information contained in this document current and accurate as of the date of publication or
revision. However, no guarantee is given or implied that the document is error free or that it is
accurate regarding any specification.
WARRANTY
Limited Warranty
Seller warrants to the original purchaser that the Product, not including accessories, shall be
free from defects in materials 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 ).
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 for 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 in
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 profits.

Warnings, Cautions, & Notes
iv Oximeter Operation Manual
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: BCI, Inc., N7 W22025 Johnson Road, Waukesha, WI
53186-1856. Telephone: [phone]. Facsimile: 262-542-3325. 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 outside the USA, contact your local distributor.
CE Notice
Marking by the symbol C0473 indicates compliance of this device to the Medical Device
Directive 93/42/EEC.
Authorized Representative (as defined by the Medical Device Directive):
Graseby Medical Ltd.
Colonial Way, Watford, Herts,
UK WD2 4LG
Phone: [phone]
Fax: [phone]

Warnings, Cautions, & Notes
Oximeter Operation Manual v
Warnings, Cautions, & Notes
KEYWORD DEFINITION
WARNING Tells you about something that could hurt the patient or hurt the operator
CAUTION Tells you something that could damage the monitor
NOTE Tells you other important information
Symbol Definitions
SYMBOL DEFINITION
r Type BF equipment
2Attention, consult accompanying documents
7 Refer servicing to qualified service personnel
D Output voltage
E Input voltage
F Printer On/Off
G Direct current
B Alarm Silence
x On/Off
1 Non AP device
8 Speaker On/Off
C Use By
Warnings
WARNING! Federal law (USA) restricts the use or sale of this device by, or on the order
of, a physician.
WARNING! Do not use this device in the presence of flammable anesthetics.
WARNING! Do not use this device in the presence of magnetic resonance imaging (MR
or MRI) equipment.
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! 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®1tape, 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).
1Microfoam® is a registered trademark of the 3M Company

Warnings, Cautions, & Notes
vi Oximeter Operation 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 certified
according to the respective IEC standards, i.e., IEC 950 for data processing equipment or
IEC 601-1 for electromedical equipment. All combinations of equipment must be in
compliance with IEC 601-1-1 systems requirements. Anyone connecting additional
equipment to the signal input port or the signal output port configures a medical system,
and, therefore, is responsible that the system complies with the requirements of the
system standard IEC 601-1-1.
Warning: Patient safety can be compromised by the use of a power supply not supplied
by BCI, Inc. Use only the power supply included with your monitor, or approved by BCI,
Inc.
WARNING! IEC 950 approved equipment must be placed outside the “patient
environment.” The patient environment is defined as an area 1.5 m (4.92 feet) from the
patient.
PATIENT ENVIRONMENT
R 1.5m (4.9 ft)
Cautions
CAUTION! Do not autoclave, ethylene oxide sterilize, or immerse the sensors in liquid.
CAUTION! 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.
CAUTION! Connect only the printer cable specifically intended for use with this device
(see Optional Supplies and Accessories).
CAUTION: Do not allow water or any other liquid to spill onto the monitor. Unplug the
external power supply from the monitor before cleaning or disinfecting the monitor.
Evidence that liquid has been allowed to enter the monitor voids the warranty.
Notes
NOTE! Operation of this device may be adversely affected in the presence of strong
electromagnetic sources, such as electrosurgery equipment.
NOTE! Operation of this device may be adversely affected in the presence of computed
tomograph (CT) equipment.
NOTE! Use only SpO2sensors supplied with, or specifically intended for use with, this
device.
NOTE! SpO2measurements may be adversely affected in the presence of high ambient
light. Shield the sensor area (with a surgical towel, for example) if necessary.

Warnings, Cautions, & Notes
Oximeter Operation Manual vii
NOTE! Dyes introduced into the bloodstream, such as methylene blue, indocyanine
green, indigo carmine, patent blue V (PBV), and fluorescein may adversely affect the
accuracy of the SpO2reading.
NOTE! Any condition that restricts blood flow, such as use of a blood pressure cuff or
extremes in systemic vascular resistance, may cause an inability to determine accurate
pulse rate and SpO2readings.
NOTE! Remove fingernail polish or false fingernails before applying SpO2sensors.
Fingernail polish or false fingernails may cause inaccurate SpO2readings.
NOTE! Batteries are user replaceable. Follow local governing ordinances and recycling
instructions regarding disposal or recycling of device components, including batteries.
NOTE! SpO2averaging is the number of pulse beats over which the SpO2value is
averaged; pulse averaging is the number of seconds over which the pulse value is
averaged.
NOTE! Hazards arising from software errors have been minimized. Hazard analysis was
performed to meet prEN1441: 1994.
NOTE! When printing, or advancing the paper, place the oximeter on it’s side so as to
assure no paper jams occur.
NOTE! 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.

Chapter 1: Introduction
Oximeter Operation Manual 1-1
Chapter 1: Introduction
About the Manual
The Operation Manual provides installation, operation, and maintenance instructions for
health-care professionals and other users, trained in monitoring respiratory and cardiovascular
activity.
Theory of Operation
The oximeter determines SpO2and pulse rate by passing two wavelengths of low intensity
light, one red and one infrared, through body tissue to a photodetector. During measurement,
the signal strength resulting from each light source depends on the color and thickness of the
body tissue, the sensor placement, the intensity of the light sources, and the absorption of the
arterial and venous blood (including the time varying effects of the pulse) in the body tissues.
Figure 1.0: Theory of Operation
1. Red and infrared LED light sources
2. Detector
The oximeter processes these signals, separating the time invariant parameters (tissue
thickness, skin color, light intensity, and venous blood) from the time variant parameters
(arterial volume and SpO2) to identify the pulse rate and calculate oxygen saturation. Oxygen
saturation calculations can be performed because oxygen saturated blood predictably absorbs
less red light than oxygen depleted blood.
Since measurement of SpO2depends on a pulsating vascular bed, any condition that restricts
blood flow, such as use of a blood pressure cuff or extremes in systemic vascular resistance,
may cause an inability to determine accurate pulse and SpO2readings.

Chapter 2: Intended Use & Monitor Features
Oximeter Operation Manual 2-1
Chapter 2: Intended Use and Monitor Features
Intended Use
The BCI 3401 Pulse Oximeter is a handheld, low cost monitor for spot checking or attended
monitoring of SpO2, pulse rate and pulse strength. The 3401 is a battery powered pulse
oximeter with an optional built-in printer. It may be used in the hospital or clinical
environment and during emergency land transport. The oximeter will operate accurately over
an ambient temperature range of 32 to 131°F (0 to 55°C). The oximeter works with all BCI
oximetry sensors providing SpO2and pulse rate on all patients from neonate to adult.
This device is not intended for continuous patient monitoring. There are no audible or visible
patient alarms.
Monitor Features
• Provides fast, reliable SpO2, pulse rate, and pulse strength measurements on any patient,
from neonates to adults.
• Ideally suited for use in intensive care units, outpatient clinics, emergency rooms, during
emergency air or land transport.
• Portable and lightweight. Weighs only 13 ounces, with batteries (369 grams).
• Ergonomically designed to fit comfortably in the palm of your hand.
• Uses four (4) standard “AA” (type IEC LR6) alkaline batteries.
• Battery life is approximately fourteen (14) hours when printing four (4) lines every five
(5) minutes. 24 hours without printing.
• Bright, easy-to-read LED displays indicate SpO2and pulse rate measurements.
• An eight-segment LED bar graph indicates pulse strength.
• Audible “beep” sounds with each pulse beat. Pitch of pulse “beep” corresponds to SpO2
value.
• Low battery indicator lights when about 30 minutes of battery use remains. A high pitch
beep also notifies the user of low battery life.
• The automatic power down turns the unit off when not in use.
• Data log prints SpO2and pulse rate readings in real time, once every five (5) seconds on
the optional printer located at the back of the unit.

Chapter 3: Controls & Features
Oximeter Operation Manual 3-1
Chapter 3: Controls & Features
Monitor Front Panel
Figure 3.1: Monitor Front Panel
%SpO
2
BPM
1. Sensor/Printer Connector
The sensor connects here, or an oximetry cable can be connected between the monitor and the
sensor. The serial printer or pc communication cable is also connected here.
2. SpO2 Numeric Display
A number shows the patient’s SpO2value in percent. Dashes (---) mean the monitor is not
able to calculate the SpO2value.
3. Pulse Rate Numeric Display
A number shows the patient’s pulse rate value in beats per minute. Dashes (---) mean the
monitor is not able to calculate the pulse rate value.
4. Pulse Strength Bar Graph
The pulse strength bar graph “sweeps” with the patient’s pulse beat. The height of the bar
graph shows the patient’s pulse strength.
5. Low Battery Indicator
During a Low Battery Attention, the highest bar graph LED quickly flashes about once every
second.

Chapter 3: Controls & Features
3-2 Oximeter Operation Manual
Figure 3.2: Monitor Operating Keys
%SpO2
BPM
6. xON OFF Key
Pressing this key turns the monitor ON and OFF.
7. FPRINT Key
Pressing this key turns on the optional printer located at the back of the monitor.
8. 8Speaker Silence Key
Momentarily pressing this key silences the speaker. Pressing it again enables speaker
operation.

Chapter 4: Operating Instructions
Oximeter Operation Manual 4-1
Chapter 4: Operating Instructions
2
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.
Unpacking the Monitor
1. Carefully remove the monitor and its accessories from the shipping carton. Save the
packing materials in case the monitor must be shipped or stored.
2. Compare the packing list with the supplies and equipment you received to make sure you
have everything you’ll need.
Install the Batteries
The oximeter uses 4 (four) standard “AA” alkaline cells, IEC Type LR6.
To install/replace the batteries:
1. Depress the battery door tab and lift up.
2. Install the negative end of each battery first, compressing the battery terminal spring until
the positive terminal clears the positive tab. Press the battery down into place.
3. Place battery door tabs into the slots of the monitor back panel, depress the door tab and
press the door into place.
NOTE: If you install disposable batteries, be sure to dispose of them in compliance with
your institution’s guidelines and local ordinances.
NOTE: The unit will hold data for about one and a half minutes with no battery power.
This will insure the safety of trend data during battery replacement.
Figure 4.0: Installing the Batteries.

Chapter 4: Operating instructions
4-2 Oximeter Operation Manual
Attaching the Sensor to the Patient
What you need to know about attaching the sensor to the patient:
2
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.
2
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).
Attaching the patient to the monitor requires these steps:
1. Choose the sensor.
2. Check the sensor and oximetry cable.
3. Clean or disinfect the sensor if using the reusable type. (Disposable sensors are for single-
patient use and do not require cleaning or disinfecting.)
4. Attach the sensor to the patient.
Choosing the Sensor
Choose the appropriate sensor from the following chart.
PATIENT SITE DESCRIPTION
Adult
> 45 Kg
Finger
Finger or Toe
Ear
3044: Sensor, Adult (reusable)
3444N, Comfort Clip™ Finger Sensor (reusable)
3043: Sensor, Universal “Y” (reusable)
1300: Sensor, Disposable, Adult Finger
3078: Sensor, Ear (reusable)
Pediatric
15-45 Kg
Finger
Finger or Toe
Ear
3044: Sensor, Adult (reusable)
3178: Sensor, Pediatric Finger
3444N, Comfort Clip™ Finger Sensor (reusable)
3043: Sensor, Universal “Y” (reusable)
1301: Sensor, Disposable, Ped. Finger
3078: Sensor, Ear (reusable)
Infant
3-15 Kg
Hand or Foot
Toe
Finger or Toe
3043: Sensor, Universal “Y” (reusable)
3025: Sensor, Wrap, Infant (reusable)
1303: Sensor, Disposable, Infant
Neonate
< 3 Kg
Hand or Foot
Foot
1302: Sensor, Disposable, Neonate
3026: Sensor, Wrap, Neonate (reusable)

Chapter 4: Operating Instructions
Oximeter Operation Manual 4-3
Care and Handling of the Sensor
2
WARNING! Misuse or improper handling of the sensor and cable could result in
damage to the sensor. This may cause inaccurate readings.
Hold the connector rather than the cable when connecting or disconnecting the sensor to the
device as shown in Figure 4.1.
Figure 4.1: Disconnecting or connecting the sensor.
%SpO
2
BPM
1. Connector
2. Cable
Do not use excessive force or unnecessary twisting when connecting, disconnecting, storing,
or when using the sensor.
When placing the sensor on the patient, allow the cable to lay across the palm of the hand and
parallel to the arm of the patient as shown in Figure 4.2.
Figure 4.2: Positioning the cable of the finger sensor.
Upon completion of patient monitoring, detach the sensor as shown in Figure 4.1 and loosely
coil the finger sensor cable.

Chapter 4: Operating instructions
4-4 Oximeter Operation Manual
Checking the Sensor and Oximetry Cable
Follow these instructions each time before you attach the sensor to the patient. This helps
ensure the sensor and oximetry cable are working properly.
2
WARNING! Using a damaged sensor may cause inaccurate readings. Inspect each
sensor. If a sensor appears damaged, do not use it. Use another sensor or contact
your authorized repair center for help.
2
WARNING! Using a damaged oximetry cable may cause inaccurate readings.
Inspect the oximetry cable. If the oximetry cable appears damaged, do not use it.
Contact your authorized repair center for help.
1. Carefully inspect the sensor to make sure it does not appear damaged.
2. If using the oximetry cable, carefully inspect the oximetry cable to make sure it does not
appear damaged.
3. If using the oximetry cable:
a. If the sensor is not already connected to the oximetry cable, connect the sensor to the
oximetry cable. Push the connectors together firmly and close the latch to secure the
connectors.
b. If the oximetry cable is not already connected to the monitor, connect the oximetry
cable to the monitor. Push the connector firmly into the monitor.
4. If not using the oximetry cable, connect the sensor to the monitor. Push the connector
firmly into the monitor.
5. If the monitor is not already on, press the xkey to turn on the monitor.
2
WARNING! If any of the integrity checks fail, do not attempt to monitor the patient.
Use another sensor or oximetry cable, or contact the equipment dealer for help if
necessary.
6. Before the sensor is attached to the patient, check the integrity of the sensor, oximetry
cable, and oximeter as follows:
a. Make sure the red light in the sensor is illuminated.
NOTE! Obstructions or dirt on the sensor’s red light or detector may cause the checks to
fail. Make sure there are no obstructions and the sensor is clean.
7. You are now ready to attach the sensor to the patient.
Cleaning or Disinfecting the Sensors
Clean or disinfect reusable sensors before attaching to a new patient.
2
WARNING! Do not autoclave, ethylene oxide sterilize, or immerse the sensors in
liquid.
2CAUTION! Unplug the sensor from the monitor before cleaning or disinfecting.
Clean the sensor with a soft cloth moistened in water or a mild soap solution. To disinfect the
sensor, wipe the sensor with isopropyl alcohol.