BCI WW1020 User manual

WW1020/WW1000
Operation Manual
-English
Catalog Number WW1922en
Version 0, April 2009
©2009 Smiths Medical family of companies. All rights reserved.

Table of Contents
Clinician’s Operation Manual i
Table of Contents
Warranty and Service Information......................................................................v
Proprietary Notice...................................................................................................................................................... v
Warranty ........................................................................................................................................................................ v
Limited Warranty................................................................................................................................................ v
Disclaimer of Warranties.................................................................................................................................. v
Conditions of Warranty.................................................................................................................................... v
Limitation of Remedies.................................................................................................................................... v
Warranty Procedure.................................................................................................................................................. vi
CE Notice ...................................................................................................................................................................... vi
Chapter 1: Introduction................................................................................... 1-1
About the Manual .................................................................................................................................................. 1-1
Denition of Symbols ...........................................................................................................................................1-1
Warnings.................................................................................................................................................................... 1-3
Cautions..................................................................................................................................................................... 1-7
Notes........................................................................................................................................................................... 1-8
Chapter 2: Intended Use and Monitor Features............................................. 2-1
Intended Use for the WW1020 Oximeter....................................................................................................... 2-1
Intended Use for the WW1000 Oximeter....................................................................................................... 2-1
Monitor Features .................................................................................................................................................... 2-1
Theory of Operation.............................................................................................................................................. 2-2
Pulse Amplitude Index ......................................................................................................................................... 2-3
Patented Technology (WW1020 only) ............................................................................................................ 2-3
Chapter 3: Controls and Features.................................................................... 3-1
Front Display ............................................................................................................................................................ 3-1
Monitor Operating Key......................................................................................................................................... 3-2
Monitor Back and Bottom Panels ..................................................................................................................... 3-3
Chapter 4: Operating Instructions .................................................................. 4-1
Unpacking the Monitor........................................................................................................................................ 4-1
Powering the Oximeter........................................................................................................................................ 4-1
Installing the Batteries.......................................................................................................................................... 4-3
External Power ........................................................................................................................................................ 4-4
AC Power ................................................................................................................................................................... 4-5
USB Power (Universal Serial Bus) ...................................................................................................................... 4-6
Turning On the Monitor....................................................................................................................................... 4-7
Checking the Monitor’s Conguration ........................................................................................................... 4-8
Checking the Monitor’s Performance ............................................................................................................. 4-8
Attaching the Sensor to the Patient ................................................................................................................ 4-9
Choosing the Sensor...........................................................................................................................................4-10
BCI® Sensors...................................................................................................................................................4-10

Table of Contents
ii Clinician’s Operation Manual
Nellcor® Sensor (WW1020 Only) ............................................................................................................4-11
Cleaning or Disinfecting the Sensors............................................................................................................4-11
Checking the Sensor and Oximetry Cable...................................................................................................4-11
Pulse Amplitude Index .......................................................................................................................................4-12
Storing the Sensor................................................................................................................................................4-14
Home Use................................................................................................................................................................4-15
Equipment and Supplies Checklist for Home Use ...........................................................................4-15
Training the Home Use Caregiver..........................................................................................................4-16
Chapter 5: Patient Record Number and Trend Data....................................... 5-1
Description ............................................................................................................................................................... 5-1
Incrementing the Patient Record Number ................................................................................................... 5-1
Memory Capacity ................................................................................................................................................... 5-1
Clearing Trend Data............................................................................................................................................... 5-1
Trend Data Output................................................................................................................................................. 5-1
Chapter 6: Optional Docking Station and Printer.......................................... 6-1
Description ............................................................................................................................................................... 6-1
Docking Station ...................................................................................................................................................... 6-2
Powering the Docking Station.................................................................................................................. 6-2
WW1090 Lithium-Ion (Li+) Rechargeable Battery Pack................................................................... 6-3
Installing the Oximeter to the Dock........................................................................................................ 6-3
Downloading Data to PC ............................................................................................................................ 6-3
Printer ......................................................................................................................................................................... 6-4
Attaching the Printer.................................................................................................................................... 6-5
Loading Paper................................................................................................................................................. 6-6
Choosing the Print Mode ........................................................................................................................... 6-7
Trend Data Condition Flags ................................................................................................................................6-8
Chapter 7: PC Communication Setup.............................................................. 7-1
Description ............................................................................................................................................................... 7-1
Power Input and Data Connector Port ......................................................................................................... 7-2
How to Set Up Equipment.......................................................................................................................... 7-3
Sensor / RS232 Port................................................................................................................................................ 7-4
How to Set Up Equipment.......................................................................................................................... 7-4
Output Format................................................................................................................................................ 7-5
Chapter 8: Maintenance................................................................................... 8-1
Routine Maintenance............................................................................................................................................ 8-1
Cleaning and Disinfecting................................................................................................................................... 8-2
Storage....................................................................................................................................................................... 8-2
Chapter 9: Troubleshooting............................................................................. 9-1
Power .......................................................................................................................................................................... 9-1
Sensor......................................................................................................................................................................... 9-2
Other ........................................................................................................................................................................... 9-3

Table of Contents
Clinician’s Operation Manual iii
Chapter 10: Optional Supplies and Accessories........................................... 10-1
Ordering Information..........................................................................................................................................10-2
Chapter 11: Specications ............................................................................. 11-1
Displays....................................................................................................................................................................11-1
Indicators.................................................................................................................................................................11-1
Keys/User Controls...............................................................................................................................................11-1
SpO2 for the WW1020 Oximeter ......................................................................................................................11-2
Pulse Rate for the WW1020 Oximeter...........................................................................................................11-3
SpO2for the WW1000 Oximeter......................................................................................................................11-4
Pulse Rate for the WW1000 Oximeter...........................................................................................................11-5
Pulse Amplitude Index for the WW1020 Oximeter ..................................................................................11-6
Pulse Amplitude Index for the WW1000 Oximeter ..................................................................................11-6
Printer .......................................................................................................................................................................11-6
Serial Data Output................................................................................................................................................11-7
Power Input and Data Connector .........................................................................................................11-7
Sensor Connector........................................................................................................................................11-7
Power Requirements...........................................................................................................................................11-7
Battery..............................................................................................................................................................11-7
AC Charger .....................................................................................................................................................11-7
USB....................................................................................................................................................................11-7
Monitor Dimensions............................................................................................................................................11-7
Dock Dimensions..................................................................................................................................................11-8
Auxiliary Inputs/Outputs ...................................................................................................................................11-8
Environmental .......................................................................................................................................................11-8
Equipment Classication...................................................................................................................................11-9
Design Standards .................................................................................................................................................11-9
Appendix A: Guidance and Manufacturer’s Declaration...............................A-1
Guidance and Manufacturer’s Declaration ...................................................................................................A-1
Electromagnetic Emissions - Emissions Test ........................................................................................A-1
Electromagnetic Immunity - Immunity Test.................................................................................................A-2
Recommended Separation Distances.............................................................................................................A-4
The serial autocorrelation technology (SAC) in the WW1020 oximeter is covered by U.S. Patent No.
5,558,096.
BCI, Comfort Clip 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 Clinician’s Operation Manual
This page is intentionally left blank.

Warranty and Service Information
Clinician’s Operation Manual v
Warranty and Service Information
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 three 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).
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 and Service Information
vi Clinician’s Operation Manual
Warranty Procedure
To obtain warranty service in the USA, you must request a Return Authorization (RA) number from
Technical Service. Reference the RA 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]
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 any 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 occurring 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, Hertfordshire,
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]

Chapter 1: Introduction
Clinician’s Operation Manual 1-1
About the Manual
The Clinician’s Operation Manual provides installation, operation, and maintenance instructions
for the health-care professional trained in monitoring respiratory and cardiovascular activity.
These instructions contain important information for safe use of the product. Read the
entire contents of these Instructions For Use, including Warnings and Cautions, before using
the monitor. Failure to properly follow warnings, cautions and instructions could result in
death or serious injury to the patient.
Denition of Symbols
SYMBOL DEFINITION
6Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a
physician.
RType BF Equipment
fAttention, see instructions for use.
7Refer servicing to qualied service personnel.
This device has no alarms.
%SpO2Percent Oxygen Saturation
pPulse Rate (beats per minute)
PI Pulse Amplitude Index
Battery Charge Indicator
External Power Indicator
xOn/O Key
1Printer LED - Real Time Printout
2Printer LED - Numeric Trend Tables
3Printer LED - Graphic Trend
Printer LED - Error
Printer Key - Select Print
Printer Key - Start / Stop Print
Docking Station LED - AC Power
Docking Station LED - USB Power
Docking Station LED - Charging Spare Battery
Printer icon: Small Pulse (WW1020 only)
Printer icon: Check Sensor
Printer icon: Searching too Long
Printer icon: Lost Pulse
Chapter 1: Introduction

Chapter 1: Introduction
1-2 Clinician’s Operation Manual
SYMBOL DEFINITION
Printer icon: Artifact (WW1020 only)
7Do not reuse. One use on one patient.
KMoisture Sensitive
1Not suitable for use in the presence of a ammable anesthetic mixture.
DOutput Voltage Connector
EInput Voltage Connector
GDirect Current
IPX2 Drip proof (monitor and dock only)
<Catalog Number
JDate of Manufacture
@Authorized Representative in the European Community
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
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.

Chapter 1: Introduction
Clinician’s Operation Manual 1-3
KEYWORD DEFINITION
WARNING Something that could hurt the patient or hurt the operator.
CAUTION Something that could damage the monitor.
NOTE Other important information.
Warnings
WARNING! This device is not intended for continuous patient monitoring. This device is
intended to measure the patient’s %SpO2and pulse rate values. There are no
audible or visible alarms.
WARNING! The monitor was not designed or tested to be an apnea monitor.
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 portable and mobile RF communication equipment,
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.
WARNING! If the accuracy of any measurement is in question, verify the patient’s vital signs
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 or
those who have access to the oversight of a professional health care provider.
The operator must be thoroughly familiar with the information in this manual
before using the device.
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! Use only SpO2sensors supplied with, or specically intended for use with, this
device.

Chapter 1: Introduction
1-4 Clinician’s Operation Manual
WARNING! Incorrectly applied sensors may give inaccurate readings. 2Refer to the
sensor insert for proper application instructions.
WARNING! Do not autoclave, ethylene oxide sterilize, or immerse the sensors in liquid. This
may cause damage to the sensor which may cause inaccurate readings.
WARNING! Unplug the sensor from the oximeter before cleaning or disinfecting to prevent
damaging the sensor or monitor, and to prevent user safety hazards.
WARNING! Measurements made at sites with low perfusion are potentially inaccurate.
Always use measurements in conjunction with other clinical signs and
symptoms.
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 be indicated depending upon the photodynamic
agent used, agent dose, skin condition, total exposure time or other factors.
Use multiple sensor sites.
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 60601-1 for electromedical equipment. All
combinations of equipment must be in compliance with IEC 60601-1-1 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 60601-1-1.

Chapter 1: Introduction
Clinician’s Operation Manual 1-5
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! The oximeter will not operate without batteries installed. Properly charged
batteries provide a reserve source of power in case of external power failure.
Never use an oximeter with discharged batteries to monitor a patient.
WARNING! Inspect battery terminals for corrosion or contamination. The monitor may not
operate properly if battery terminals are corroded or contaminated. Do not use
until battery terminals have been properly cleaned and repaired.
WARNING! Check expiration date of batteries. The monitor may not operate properly if
expired batteries are used. Do not use until proper batteries can be obtained.
WARNING! Remove device batteries prior to long term storage.
WARNING! Do not allow the patient to handle the device if the battery door has been
removed, except while installing new batteries.
WARNING! Disconnect the external power supply from the monitor or Docking Station
before disinfecting or cleaning the monitor.
WARNING! Do not plug the monitor or Docking Station into an outlet controlled by a wall
switch.
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 contact the AC power supply connectors, or
a safety hazard may result. Ensure that hands are thoroughly dry before
handling the AC power supply.
WARNING! Do not place the monitor or Docking Station in the patient’s bed or crib. Do not
place the monitor or Docking Station on the oor.
WARNING! Failure to place the monitor or Docking Station 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.
R 1.5 m (4.9 ft.)

Chapter 1: Introduction
1-6 Clinician’s Operation Manual
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! Ensure the device’s AC rating is correct for the AC voltage at your installation
site before using this monitor. The monitor’s AC rating is shown on the external
power supply. If the rating is not correct, do not use the monitor. Contact
the Smiths Medical PM, Inc. service department, or your authorized service
representative, for help.
WARNING! Use only the power supply included with your monitor, or approved by Smiths
Medical PM, Inc. Use of an inappropriate power supply may cause a patient
shock hazard or cause the oximeter to stop monitoring. See Chapter 10:
Optional Supplies & Accessories, for additional specic information.
WARNING! The Docking Station must have a Printer or Printer Port Cover installed. Failure
to do so may cause a risk of electrical shock to the patient or operator or risk
damage to the equipment.
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, high 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
Clinician’s Operation Manual 1-7
Cautions
CAUTION! Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
CAUTION! 7 Do not disassemble unit, not user serviceable. Refer to qualied service
personnel.
CAUTION! Failure to charge the monitor while the monitor is in long term storage may
shorten the battery life. Charge the monitor while it is in storage to ensure the
longest battery life.
CAUTION! Due to limitations of the Li-Ion chemistry, the rechargeable battery pack
should not be charged at ambient temperatures above 45 °C (113 °F) or
below 5 °C (41 °F).
CAUTION! The WW1090 rechargeable battery pack is shipped with only 30% of full charge.
The battery pack must be charged completely before use.
CAUTION! The WW1090 rechargeable battery pack utilizes Li-Ion secondary cells. Dispose
of spent batteries in compliance with your institution’s guidelines and local
ordinances.
CAUTION! Observe proper battery polarity (direction) when replacing batteries.
CAUTION! Do not allow water or any other liquid to spill onto the monitor or Docking
Station. Do not autoclave, ethylene oxide sterilize, or immerse the monitor or
Docking Station in liquid. Evidence that liquid has been allowed to enter the
monitor or Docking Station voids the warranty.
CAUTION! Where the equipment has accidentally gotten wet, it should be wiped dry
externally and allowed to dry thoroughly before use.
CAUTION! Before cleaning or disinfecting the printer, unplug the AC adapter, remove the
batteries and remove the paper.
CAUTION! Do not allow printer paper to become wet. If the printer paper gets wet, remove
the paper immediately. Do not use the printer until the paper is replaced.
CAUTION! Chemicals used in some cleaning agents may cause brittleness of plastic parts.
Follow cleaning instructions in this manual.
CAUTION! Cleaning with disinfectants, including alcohol, may shorten the life of the plastic
or electronic parts, but appropriate disinfection must still be performed.
CAUTION! Pressing any key with sharp or pointed instruments may permanently damage
the keypad. Only press keys with your nger.

Chapter 1: Introduction
1-8 Clinician’s Operation Manual
Notes
NOTE: The WW1090 rechargeable battery pack utilizes circuitry that optimizes the
charging of the batteries. New packs will require multiple charge / discharge
learning cycles before optimum performance is obtained.
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.
NOTE: A Patient Simulator does not calibrate the monitor. The monitor does not require
calibration. A Patient Simulator provides a known SpO2and pulse rate to the
monitor that allows the monitor’s performance to be checked.
NOTE: A Patient Simulator cannot be used to assess the accuracy of a pulse oximeter and/
or sensor.

Chapter 2: Intended Use and Monitor Features
Clinician’s Operation Manual 2-1
Intended Use for the WW1020 Oximeter
The BCI®WW1020 pulse oximeter is intended for spot-checking applications (non continuous
use). It monitors and displays patient’s functional oxygen saturation (%SpO2), pulse rate
( p), pulse signal strength, and pulse amplitude index (PI) readings. It may be used by
physicians, respiratory therapists, nurses, certied nurse assistants, emergency medical
technicians, sleep technicians, and home users. The intended patient population ranges from
neonatal to adult. It may be used on patients with low perfusion or during patient motion. The
WW1020 may be used in the hospital or clinical environment, during emergency land transport,
and in the home.
WARNING! The monitor was not designed or tested to be an apnea monitor.
Intended Use for the WW1000 Oximeter
The BCI®WW1000 pulse oximeter is intended to be used for spot-checking (non-continuous use).
It monitors and displays a patient’s functional oxygen saturation (%SpO2), pulse rate (p), pulse
signal strength, and pulse amplitude index (PI) readings. It may be used by physicians, respiratory
therapists, nurses, certied nurse assistants, emergency medical technicians, sleep technicians,
clinicians, and home users. The intended patient population ranges from infant to adult. It can
be used on patients with low perfusion. The WW1000 may be used in the hospital or clinical
environment, during emergency land transport, and in the home.
WARNING! The monitor was not designed or tested to be an apnea monitor.
Monitor Features
Provides fast, reliable SpO• 2, pulse rate, and pulse signal strength measurements on
any patient, from neonate to adult for the WW1020 or from small infant to adult for the
WW1000.
Maintains accurate readings during periods of patient motion (WW1020 only) and when•
monitoring patients with low perfusion.
Ideally suited for use in hospitals, outpatient clinics, emergency rooms, during emergency•
land transport, in sleep labs, or in-home use.
Portable and lightweight. Weighs only 330 grams (12 ounces), with 4“AA”batteries.•
On-board sensor storage cradle holds the nger sensor when not in use.•
Power options include four (4) standard“AA”(type IEC LR6) alkaline batteries, a•
rechargeable Lithium Ion battery pack, USB power, or an AC power adapter.
Rechargeable battery life for a new battery is approximately thirty-one• (31) hours for the
WW1020, fty-four (54) hours for the WW1000.
An easy to read battery gauge indicates the charge level and provides a low battery alert.•
Large, bright, easy-to-read LED display indicates SpO• 2and pulse rate measurements.
2 Nine-segment LED bar graphs indicate pulse signal strength and pulse amplitude index.•
Optional docking station transforms the device into a table top pulse oximeter, and can•
also be used to recharge the monitor’s lithium Ion battery pack, and a spare battery pack.
Optional printer allows for printing of trend information or real time data logs.•
Chapter 2: Intended Use and Monitor Features

Chapter 2: Intended Use and Monitor Features
2-2 Clinician’s Operation Manual
Theory of Operation
The pulse oximeter determines %SpO2and pulse rate by passing two wavelengths of low
intensity light, one red and one infrared, through body tissue to a photodetector. Information
about wavelength range can be especially useful to clinicians. Wavelength information for this
device can be found in the SpO2Specications section of this manual.
Pulse identication is accomplished by using plethysmographic techniques, and oxygen
saturation measurements are determined using spectrophotometric oximetry principles. 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 eects of the pulse) in the
body tissues.
Figure 2-1: Theory of Operation
Low intensity Red and Infrared LED light sources
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 pulses and calculate functional oxygen saturation. Oxygen saturation
calculations can be performed because blood saturated with oxygen predictably absorbs less red
light than oxygen-depleted blood.
WARNING! Since measurement of SpO2depends on a pulsating vascular bed, any
condition that restricts blood ow, such as the use of a blood pressure cu or
extremes in systemic vascular resistance, may cause an inability to determine
accurate SpO2and pulse rate readings.
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, high 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.
1
2
1
2

Chapter 2: Intended Use and Monitor Features
Clinician’s Operation Manual 2-3
Pulse Amplitude Index
The PI value is a relative measure of pulse-signal strength over time at a pulse oximeter
monitoring site, and is non-pulsatile in nature. Pulse Amplitude Index is dened as
PI = (100 * AC)/DC where AC is the alternating current (pulsatile component of the signal)
and DC is direct current (non-pulsatile component of the signal). For more information, see
Pulse Amplitude Index in Chapter 4: Operating Instructions.
NOTE! The PI value is a relative value that varies from patient to patient.
Patented Technology (WW1020 only)
This oximeter incorporates patented technology and noise reducing hardware to enhance the
oximeter’s ability to detect pulse amplitude in patients with poor peripheral perfusion. Blood
Pulse Detection Method Using Serial Autocorrelation (SAC), patent number 5,558,096, analyzes
a digitized signal, in real time, and compares it with previous pulse data. If similar characteristics
to previous data are recognized, the device conrms a valid pulse. In essence, an individual’s
pulse data is retained and used as a template to accept or reject future pulse signals. Patented
technology, digital signal processing, and a greatly improved signal to noise ratio, provide for
improved performance.

Chapter 2: Intended Use and Monitor Features
2-4 Clinician’s Operation Manual
This page is intentionally left blank.