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
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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.