Smiths Medical 1850 User manual

Oximeter
Clinician’s Operation Manual
Catalog Number 1850
Version 15, March 2005
© 2005 Smiths Medical family of companies.
All rights reserved.

Revision History
Version Release
Date Change(s)
15 March,
2005
Removed the statement that
claims that pressing the I.D./Clear
key will cause printing to stop
(page 7-6)
Added 1310 DOT reusable finger
sinsor and 1311 sensor tape.
Updated Smiths family copyright
statement.
Updated registered trademark
statements.
Changed font to Myriad Pro.
Added this Revision History page.
Updated the Smiths logo to
include a ® symbol.
Smiths and BCI and Comfort Clip are trademarks of the
Smiths Medical family of companies.
Microfoam is a trademark of the 3M Company.
The symbol ® indicates the trademark is registered in the U.S.
Patent and Trademark Office and certain other countries.

Table of Contents
Oximeter Clinician’s Operation Manual i
Table of Contents
Chapter 1: Introduction............................................................................ 1-1
Proprietary Notice .......................................................................................... 1-1
Warranty ............................................................................................................ 1-1
Limited Warranty .................................................................................... 1-1
Disclaimer of Warranties ...................................................................... 1-1
Conditions of Warranty ........................................................................ 1-2
Limitation of Remedies......................................................................... 1-2
Warranty Procedure............................................................................... 1-3
CE Notice ........................................................................................................... 1-3
Definition of Symbols.................................................................................... 1-4
Warnings, Cautions, and Notes ................................................................. 1-5
Chapter 2: Monitor Features................................................................... 2-1
About the Manuals......................................................................................... 2-1
Theory of Operation ...................................................................................... 2-1
Intended Use.................................................................................................... 2-2
Monitor Features ............................................................................................ 2-2
Chapter 3: Controls.................................................................................... 3-1
Chapter 4: Operating Instructions........................................................ 4-1
Unpacking the Monitor ................................................................................ 4-1
AC Power ........................................................................................................... 4-1
Attaching the Sensor to the Patient ........................................................ 4-2
Choosing the Sensor ............................................................................. 4-3
Care and Handling of the Sensor...................................................... 4-4
Checking the Sensor and Oximetry Cable..................................... 4-6
Cleaning or Disinfecting the Sensors ....................................................4-10
Turning On the Monitor.............................................................................4-11
Alarms...............................................................................................................4-13
Alerts .................................................................................................................4-14
BATT Attention ..............................................................................................4-15
Turning Off the Monitor.............................................................................4-16
Checking the Monitor’s Performance ...................................................4-16

Table of Contents
ii Oximeter Clinician’s Operation Manual
Chapter 5: Changing the Monitor’s Settings .................................... 5-1
Silencing Alarm and Alert Tones............................................................... 5-1
Changing the Alarm and Alert Tone Volume....................................... 5-1
Changing the Brightness of the Display ................................................ 5-1
Changing the Pulse Beep Volume............................................................ 5-2
Changing the Alarm Limits ......................................................................... 5-2
Chapter 6: Patient Numbers and Trend Data ................................... 6-1
Description........................................................................................................ 6-1
Manually Incrementing the Patient Number ....................................... 6-1
Viewing Trend Data ....................................................................................... 6-1
Clearing Trend Data....................................................................................... 6-2
Chapter 7: Printer........................................................................................ 7-1
Description........................................................................................................ 7-1
Selecting Print Mode For Trend Data...................................................... 7-2
Compatible Printers....................................................................................... 7-3
What You’ll Need for Printing .................................................................... 7-3
Setting Up the Monitor and the Printer ................................................. 7-4
Trend Printouts................................................................................................ 7-5
Collecting Trend Data ........................................................................... 7-5
Manually Incrementing the Patient Number ............................... 7-5
Clearing Trend Data............................................................................... 7-5
Printing Trend Data ............................................................................... 7-6
Chapter 8: Operating Modes .................................................................. 8-1
About the Monitor’s Operating Modes .................................................. 8-1
Home Use Mode ............................................................................................. 8-1
Setting Up the Monitor for Home-Use.................................................... 8-2
Equipment and Supplies Checklist for Home-Use ............................. 8-3
Training the Home-Use Caregiver............................................................ 8-4
Turning Off Home-Use Mode..................................................................... 8-6
Sleep Study Mode .......................................................................................... 8-7
Setting Up the Monitor for Sleep Study Mode .................................... 8-8
Turning Off Sleep Study Mode .................................................................. 8-9
PC Communication Setup.........................................................................8-10
Transferring Sleep Study Data to a PC..................................................8-11
Chapter 9: Charging the Monitor.......................................................... 9-1

Table of Contents
Oximeter Clinician’s Operation Manual iii
Chapter 10: Maintenance ......................................................................10-1
Schedule of Maintenance..........................................................................10-1
Correcting the SENSOR Alert....................................................................10-2
Chapter 11: Troubleshooting...............................................................11-1
Chapter 12: Optional Supplies and Accessories............................12-1
Ordering Information..................................................................................12-2
Chapter 13: Specifications.....................................................................13-1
Oximeter ..........................................................................................................13-1

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Chapter 1: Introduction
Oximeter Clinician’s Operation Manual 1-1
Chapter 1: Introduction
Proprietary Notice
Information contained in this document is copyrighted by Smiths Medi-
cal PM, Inc. and may not be duplicated in full or part by any person with-
out prior written approval of Smiths Medical PM, 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 material and workmanship
under normal use, if used in accordance with its labeling for two years
from the date of shipment to the original purchaser.
Seller warrants to the original purchaser that the reusable oximeter sen-
sors 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 LIM-
ITED, IS IN LIEU OF AND EXCLUDES ALL OTHER WARRANTIES
WHETHER EXPRESS OR IMPLIED, BY OPERATION OF LAW OR OTHER-
WISE, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES
OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

Chapter 1: Introduction
1-2 Oximeter Clinician’s Operation Manual
Seller disclaims responsibility of the suitability of the Product for any par-
ticular medical treatment or for any medical complications resulting
from the use of the Product. This disclaimer is dictated by the many ele-
ments which are beyond Seller’s control, such as diagnosis of patient,
conditions under which the Product may be used, handling of the Prod-
uct 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 accesso-
ries 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 REM-
EDY. In no event will Seller’s liability arising out of any cause what-
soever (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 profits.

Chapter 1: Introduction
Oximeter Clinician’s Operation Manual 1-3
Warranty Procedure
To obtain warranty service in the USA, you must request a Customer Ser-
vice Report (CSR) number from Technical Service. Reference the CSR
number when returning your Product, freight and insurance prepaid, to:
Smiths Medical PM, Inc.
N7 W22025 Johnson Drive
Waukesha, WI 53186-1856
Phone: [phone]
Fax: [phone]
Seller will not be responsible for unauthorized returns or for loss or dam-
age to the Product during the return shipment. The repaired or replaced
Product will be shipped, freight prepaid, to Purchaser.
To obtain warranty information outside of the USA, contact your local
distributor.
Keep all original packing material, including foam inserts. If you need to
ship the device, use only the original packaging material, including
inserts. Box and inserts should be in original condition. If original ship-
ping material in good condition is not available, it should be purchased
from Smiths Medical PM, Inc.
Damages occurred in transit in other than original shipping containers
are the responsibility of the shipper. All costs incurred returning devices
for repair are the responsibility of the shipper.
CE Notice
Marking by the symbol m indicates compliance of this device to
the Medical Device Directive
93/42/EEC.
Authorized Representative (as defined by the Medical Device Directive):
Smiths Medical International Ltd.
Colonial Way, Watford, Herts,
UK, WD24 4LG
Phone: [phone]
Fax: [phone]

Chapter 1: Introduction
1-4 Oximeter Clinician’s Operation Manual
Definition of Symbols
Symbol Definition
6Type B equipment
2Attention, consult accompanying documents
7Refer servicing to qualified service personnel
BAlarm Silence
1Non AP Device
OOn
POff
JID Clear
Up and Down Keys
IAlarm Volume
KPulse Volume
CUse By
REF Catalog Number
yDate of Manufacture
SN Serial Number
KMoisture Sensitive

Chapter 1: Introduction
Oximeter Clinician’s Operation Manual 1-5
Warnings, Cautions, and Notes
Keyword Definition
2WARNING! Tells you about something that could hurt the
patient or hurt the operator
CAUTION! Tells you about something that could damage the
monitor
NOTE! Tells you other important information
2WARNING! 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 Oximeter. Failure to properly follow warnings, cau-
tions and instructions could result in death or serious injury to
the patient.
2WARNING! Federal law (USA) restricts the use or sale of this
device by, or on the order of, a physician.
2WARNING! Do not use this device in the presence of flammable
anesthetics.
2WARNING! Do not use this device in the presence of magnetic
resonance imaging (MR or MRI) equipment.
2WARNING! This device must be used in conjunction with clini-
cal signs and symptoms. This device is only intended to be an
adjunct in patient assessment.
2WARNING! Prolonged use or the patient’s condition may
require changing the sensor site periodically. Change the sen-
sor site and check skin integrity, circulatory status, and correct
alignment at least every 4 hours.
2WARNING! When attaching sensors with Microfoam
1. Microfoam®is a registered trademark of the 3M Company.
®1 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).

Chapter 1: Introduction
1-6 Oximeter Clinician’s Operation Manual
2WARNING! Connect the AC power cord to a grounded, three-
wire outlet. Failure to comply may compromise patient isola-
tion.
2WARNING! In the event that earth ground integrity is lost, the
performance of this device and/or other devices nearby may
be affected due to excessive RF emissions.
2WARNING! Patient safety can be compromised by the use of a
power supply not supplied by Smiths Medical PM, Inc. Use only
the power supply included with your monitor, or one
approved by Smiths Medical PM, Inc.
2WARNING! When connecting this monitor to any instrument,
verify proper operation before clinical use. Refer to the instru-
ment’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 equip-
ment. 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 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.

Chapter 1: Introduction
Oximeter Clinician’s Operation Manual 1-7
2WARNING! IEC 950 approved equipment must be placed out-
side of the patient environment. The patient environment is
defined as an area 1.5 m (4.92 feet) from the patient.
Example of the patient environment. The dimensions are not
prescriptive.
Figure 1-1: Patient Environment (side)
Figure 1-2: Patient Environment (top)

CAUTION! The monitor is equipped with an internal recharge-
able battery. Do not attempt to remove or replace the internal
rechargeable battery.
7Refer servicing to qualified personnel.
CAUTION! Ensure the monitor’s AC rating is correct for the AC
voltage at your installation site before using the 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 local dis-
tributor for help.
CAUTION! Do not autoclave, ethylene oxide sterilize, or
immerse the sensors in liquid. Evidence that liquid has been
allowed to enter the monitor voids the warranty.
CAUTION! This device is intended for use by trained healthcare
professionals. The operator must be thoroughly familiar with
the information in this manual before using the device.
CAUTION! Monitors not in use must be fully charged at least
every five months, otherwise the battery will no longer be able
to accept a charge.
CAUTION! Connect only the printer cable specifically intended
for use with this device (see Optional Supplies and Accessories).
CAUTION! Failure to charge the monitor while it is not being
used may shorten the battery life. Charge the monitor while it
is not being used to ensure the longest battery life.
CAUTION! Do not attempt to stand the oximeter upright when
not using the protective rubber boot. Position the oximeter on
its back.
Chapter 1: Introduction
1-8 Oximeter Clinician’s Operation Manual

NOTE! Operation of this device may be adversely affected in
the presence of strong electromagnetic sources, such as elec-
trosurgery equipment.
NOTE! Operation of this device may be adversely affected in
the presence of computed tomography (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.
NOTE! Dyes introduced into the bloodstream, such as methyl-
ene 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 resis-
tance, may cause an inability to determine accurate SpO2and
pulse rate readings.
NOTE! Remove fingernail polish or false fingernails before
applying SpO2sensors. Fingernail polish or false fingernails
may cause inaccurate SpO2readings.
NOTE! Batteries are not user replaceable.
Service Personnel: Follow local governing ordinances and
recycling instructions regarding disposal or recycling of device
components, including batteries.
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 Clinician’s Operation Manual 1-9

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Chapter 2: Monitor Features
Oximeter Clinician’s Operation Manual 2-1
Chapter 2: Monitor Features
About the Manuals
The Clinician’s Operation Manual provides installation, operation, and
maintenance instructions for the health-care professional trained in
monitoring respiratory and cardiovascular activity.
The Home-Use Instruction Book provides operation and maintenance
instructions for the home-use caregiver. The home-use caregiver is
assumed to be trained in oximeter use by a doctor or other health-care
professional. The Home-Use Instruction Book supplements, and does
not replace, training provided by a health-care professional in oximeter
use.
Theory of Operation
The oximeter determines SpO2and pulse rate by passing two wave-
lengths of light, one red and one infrared, through body tissue to a pho-
todetector. 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 absorp-
tion of the arterial and venous blood (including the time varying effects
of the pulse) in the body tissues.
Figure 2-1: Theory of Operation
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 satura-
tion calculations can be performed because oxygen saturated blood
predictably absorbs less red light than oxygen depleted blood.

Chapter 2: Monitor Features
2-2 Oximeter Clinician’s Operation Manual
Intended Use
The Oximeter provides fast, reliable SpO2, pulse rate, and pulse strength
measurements. It may be used in the hospital or clinical environment,
during emergency air or land transport, or for in-home use. The oximeter
will operate accurately over an ambient temperature range of 32 to 104°
F (0 to 40°C). The oximeter works with all BCI® oximetry sensors provid-
ing SpO2and pulse rate on all patients from neonate to adult (see sec-
tion Choosing the Sensor under Attaching the Sensor to the Patient).
The oximeter permits patient monitoring with adjustable alarm limits as
well as visible and audible alarm signals. The oximeter has three modes
of operation: Clinician Mode, Home-Use Mode, and Sleep Study Mode.
Clinician Mode aids the health care professional in monitoring patient
activity. The Home Use Mode permits the home-use caregiver to moni-
tor a patient within the home environment. Finally, Sleep Study Mode
allows the health care professional to record sleep study data which may
later be transferred to a PC and analyzed.
Monitor Features
• Provides fast, reliable SpO2, pulse rate, and pulse strength measure-
ments on any patient, from neonates to adults.
• Ideally suited for use in intensive care units, outpatient clinics, emer-
gency rooms, during emergency air or land transport, or for in-home
use.
• Portable and lightweight. Weighs only 19 ounces (539 grams).
• Ergonomically designed to fit comfortably in the palm of your hand.
• Uses an internal, rechargeable battery.
• Battery life is approximately 24 hours in continuous use. Battery fully
charges in about 6 hours.
• Bright, easy-to-read LED displays indicate SpO2and pulse rate mea-
surements. Brightness is user-adjustable.
• An eight-segment LED bar graph indicates pulse strength.
• Positive identification of SpO2or pulse rate alarm. Adjustable high
and low alarm limits for SpO2and pulse rate measurements.
• Adjustable volume (including off) alarm and alert tones.
• Adjustable volume (including off) “beep” sounds with each pulse
beat. Pitch of pulse “beep” corresponds to SpO2value.