Novametrix Medical Systems 515B User manual

Novametrix Medical Systems Inc. Wallingford, Connecticut, U.S.A. 06492.
Copyright 1995, 1996. All rights reserved. No part of this manual may be reproduced
without the written permission of Novametrix Medical Systems Inc. Printed in U.S.A.
Model 515B and 515C
Pulse Oximeter
User’s Manual
This manual covers Model 515B (Cat. No. 6500-00) and Model 515C (Cat. No. 6550-00)
April 17, 1996
Catalog No. 6500-23-02/6550-23-02

Rev. 02 Model 515B/C User’s Manual ii
R
Revision History
29-Mar-95 Release at revision 00
11-Apr-95 Updated to revision 01; corresponds to software version 02
17-Apr-96 Updated to revision 02 (R-N389). Addendums A and B incorporated, also Single
Patient Use SpO2sensor information added, use with software version 04.

iii Model 515B/C User’s Manual Rev. 02
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Rev. 02 Model 515B/C User’s Manual iv
G
Guarantee
Equipment manufactured or distributed by Novametrix Medical Systems Inc., is fully
guaranteed, covering materials and workmanship, for a period of one year from the date of
shipment, except for certain disposable products and products with stated guarantees other than
one year. Novametrix reserves the right to perform guarantee service(s) at its factory, at an
authorized repair station, or at the customer’s installation.
Novametrix’ obligations under this guarantee are limited to repairs, or at Novametrix’ option,
replacement of any defective parts of our equipment, except fuses, batteries, and calibration
gasses, without charge, if said defects occur during normal service.
Claims for damages during shipment must be filed promptly with the transportation company.
All correspondence concerning the equipment must specify both the model name and number,
and the serial number as it appears on the equipment.
Improper use, mishandling, tampering with, or operation of the equipment without following
specific operating instructions will void this guarantee and release Novametrix from any further
guarantee obligations.
Caution: Federal (U.S.A.) law restricts this device to sale, distribution,or use by or on the order
of a licensed medical practitioner.
Copyright 1995, 1996, Novametrix Medical Systems Inc. This document contains
information which is proprietary and the property of Novametrix Medical Systems Inc., and
may not be reproduced, stored in a retrieval system, translated, transcribed, or transmitted, in
any form, or by any means, without prior explicit written permission from Novametrix Medical
Systems Inc.
Service Department
For factory repair service, call toll free
1-800-243-3444
In Connecticut, call Collect [phone]
Telex 956-054
Facsimile [phone]

v Model 515B/C User’s Manual Rev. 02
Service Policy
Novametrix Medical Systems Inc. will provide Warranty Service Support to its customers
within 48 hours of receiving a telephone request for technical support. This 48 hour period
begins once a service request is placed through the Factory Technical Support Department in
Wallingford, Connecticut.Novametrix provides factory direct technical support to its customers
through a technical support group located in Wallingford, Connecticut and company service
representatives located throughout the United States. All Technical Support for Novametrix
products is provided “Factory Direct.”
Novametrix provides 24 hour a day technical support accessibility via telephone numbers (800)
243-3444 or [phone]. After hours technical support requests (before 8:00 AM and after
5:00 PM Eastern Time) will be responded to promptly by the Technical Support On-Call staff.
It is suggested that any person calling in for technical support have the inoperative equipment
available for preliminary troubleshooting as well as product identification. Novametrix reserves
the right to repair or replace any product found to be defective during the warranty period.
Repair may be provided in the form of replacement exchange parts or accessories, on-site
technical repair assistance or complete system exchanges. Repairs provided due to product
abuse or misuse will be considered “non-warranty” and invoiced at the prevailing service rate.
Any replaced defective material is expected to be returned to Novametrix within 10 days of
being provided in order to avoid additional charges. Exchanged material should be returned
promptly and directly to Novametrix using the return paperwork and shipping label(s) provided.
Transferring return materials to local sales or dealer representatives does not absolve return
responsibility.
Novametrix manufactures equipment that is generally “user serviceable” and can usually be
repaired with the replacement of a plug-in electro-mechanical assembly by the clinical end user.
When repair parts are provided, the recipient can call into Novametrix for on-line replacement
assistance and repair assurance. In the event a replacement part requires increased technical
capability, Technical Support may request Biomedical assistance, provide on-site technical
support or complete replacement equipment. If the customer requires the return of their original
product, the exchange material will be considered “loaner material” and exchanged again after
the customer equipment is repaired.
Novametrix promotes customer participation in warranty repairs should they become necessary.
This program allows for customer training and a smooth transition into self-maintenance after
warranty, which can provide substantial cost savings on repairs throughout the product’s life.
The Novametrix Technical Support Department can provide technical product support at a level
appropriate to most customers protocol and budget requirements. Please contact the Technical
Support Group at Novametrix for additional information.
Additional Novametrix Technical Support Programs:
• Focus Series Technical Training Seminars
• Test Equipment and Test Kits
• Service Contract / Part Insurance Plans
• On-Site Technical Support
• 24 hr. telephone support
• “Demand Services”
Flat rate parts-exchange,
Flat rate return for repair
Time and Material,
Full warranty, discounted replacement sensors.

Rev. 02 Model 515B/C User’s Manual vi
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Contents
Section Title Page
1 Description ................................................................................. 1
Principles of Operation .......................................................................1
Trademark Acknowledgments ............................................................2
2 Patient Safety ............................................................................. 3
Indications and Usage ........................................................................3
Warnings .............................................................................................4
Cautions ..............................................................................................5
3 Front and Rear Panel Illustrations ........................................... 7
4 Preparing For Use ......................................................................9
Monitor Power Up ...............................................................................9
Monitor Power Down .........................................................................10
Battery Operation ..............................................................................11
Long Term Storage .....................................................................11
5 Monitor Operation .................................................................... 13
SpO2and Pulse Rate Displays .........................................................13
Pulse Activity Bar ..............................................................................14
Plethysmogram Display ....................................................................14
Alert Limit Violations .........................................................................15
Alert Limits ........................................................................................16
Manually Setting Alert Limits .......................................................16
Auto Alert Limits ..........................................................................17
Audible Alert Muting ..........................................................................18
Alert Volume Control .........................................................................18
Pulse Beep Volume Control ..............................................................19
Contrast Control ................................................................................19
Resetting to Factory Defaults ............................................................20
6SpO
2Sensors ........................................................................... 21
OxySnap™ Connectors ....................................................................22
Finger Sensor ...................................................................................22
Finger Sensor Quick Check ..............................................................23
Y-Sensor ...........................................................................................24
Y-Sensor Application using Y-Strip Tapes, or Foam Wrap ...............25
Y-Sensor Application using Ear Clip .................................................27

vii Model 515B/C
User’s Manual Rev. 02
Y-Sensor Quick Check .....................................................................29
Single Patient Use SpO2Sensors ....................................................29
Single Patient Use SpO2Sensor Application ...................................30
Single Patient Use SpO2Sensor Quick Check ................................. 32
7 Troubleshooting .......................................................................33
8 Maintenance .............................................................................35
Cleaning and Sterilization .................................................................35
Monitor ........................................................................................ 35
Finger Sensor .............................................................................35
Y-Sensor .....................................................................................35
Y-Strip Tapes and Single Patient Use SpO2Sensors ................ 36
Ear Clip ....................................................................................... 36
Battery Maintenance .........................................................................36
Mains Voltage Configuration .............................................................37
Fuse Replacement ......................................................................37
Changing the Mains Voltage Setting ..........................................38
9 Specifications ...........................................................................41
Pulse Oximeter .................................................................................41
Principle of Operation ................................................................. 41
SpO2(Oxygen Saturation) ..........................................................41
Pulse Rate .................................................................................. 41
Sensors ....................................................................................... 41
Plethysmogram (Model 515C only) ............................................41
General Specifications ......................................................................41
Alerts ........................................................................................... 41
Display ........................................................................................42
Physical ...................................................................................... 42
Electrical .....................................................................................42
10 Accessories ..............................................................................43

Rev. 02 Model 515B/C User’s Manual 1
1
Description
This manual is written for users of the Novametrix Model 515B or 515C Pulse Oximeter. The
Model 515B/C provides reliable continuous measurement, display, and alerts for oxygen
saturation (SpO2) and pulse rate. The monitor can be powered from its rechargeable internal
battery or from the AC Mains.
Principles of Operation
The Model 515B/Cmeasures oxygen saturation using sensors that contain red and infrared (660
and 940 nanometer) light sources, called LEDs. The light energy from each LED is beamed
through a sample cell—a pulsating vascular bed, the patient’s finger or toe for example. The
remaining light energy not absorbed by the sample cell reaches a light receptor in the sensor,
called a photodiode. Oxygen saturated blood absorbs different amounts of light at each
wavelength as compared to unsaturated blood. Therefore, the amount of light absorbed by the
blood in each pulse can be used to calculate oxygen saturation.
The Model 515B/C is calibrated to display “functional” saturation. This differs from the
“fractional” saturation value displayed by most co-oximeters. Functional saturation is defined
as:
This can be considered to represent the amount of oxyhemoglobin as a percentage of the
hemoglobin that can be oxygenated. Dysfunctional hemoglobins (COHb and METHb) are not
included in the measurement of functional saturation.
Pulse Rate is calculated by measuring the time interval between peaks of the infrared light
waveform. The inverse of this measurement is displayed as pulse rate.
The oxygen saturation and pulse rate values are updated once each second. Presence of a pulse
is indicated visibly bya bar graphdisplay, a plethysmogram graphic display (Model 515C only),
and audibly by a “beep.”
The Model 515B/C must be used in conjunction with SuperBright™ Sensors. See
“Accessories” on page 43 for a list of available sensors and accessories.
Functional Saturation = HbO2
100 - (COHb + METHb)
HbO2 = Fractional Hemoglobin
COHb = Carboxyhemoglobin
METHb = Methemoglobin

1 Description
Trademark Acknowledgments
2 Model 515B/C
User’s Manual Rev. 02
Trademark Acknowledgments
SuperBright, Y-STRIP and Y-SENSOR are trademarks of Novametrix Medical Systems Inc.

Rev. 02 Model 515B/C User’s Manual 3
2
Patient Safety
Pulse oximetry is a non-invasive method of monitoring the oxygen saturation of arterial blood.
Pulse oximeters display oxygen saturation of functional hemoglobin and therefore the accuracy
may be interfered with by carboxyhemoglobin or other dyshemoglobins present in significant
concentrations. Oxygen saturation monitoring is intended to be used in a variety of clinical
situations, including, but not limited to respiratory therapy, anesthesia, intensive care, and
emergency.
The Model 515B/C Pulse Oximeter has electrically isolated inputs. Patient leakage current
flowing from the instrument to ground is limited to less than 10 µA at 120 V, 60 Hz. Patient
isolation is greater than 10 MΩ, 2500 V rms at 60 Hz. For maximum patient and operator safety,
the following procedures are recommended;
• Failure of Operation: If the monitor fails to respond as described, do not use until the
situation has been corrected by qualified personnel.
• Keep the monitor and its accessories clean.
• Do not operate the monitor when it is wet due to spills or condensation.
• Do not operate the monitor if it appears to have been dropped or damaged.
• Connect the line cord only to a grounded hospital grade outlet. The Model 515B/C
should be connected to the same electrical circuit as other equipment in use on the
patient. Outlets on the same circuit can be identified by the hospital’s engineering
department.
Indications and Usage
The Model 515B/C is intended to be used for monitoring functional oxygen saturation and
pulse rate in circumstances where it is desirable to monitor patient oxygenation. The monitor is
designed to monitor all patients including adult, pediatric, and neonatal. The Model 515B/C is
not intended for any other purpose.
NOTE: Components of this product and its associated accessories which may have patient
contact are free of latex.

2 Patient Safety
Warnings
4 Model 515B/C
User’s Manual Rev. 02
Warnings
•Explosion Hazard: Do NOT use the Model 515B/C in the presence of flammable
anesthetics. Use of this instrument in such an environment may present an explosion
hazard.
•Electrical Shock Hazard: Always turnthe oximeter off, and removethe AC powercord
before cleaningit. Do NOT use a damaged sensor or onewith exposed electrical contacts.
Refer servicing to qualified service personnel.
•Patient Safety: Extreme care should be exercised with neonates to assure continued
circulation distal to the sensor site after application.
•Failure of Operation: If the oximeter fails to respond as described, do not use it until
the situation has been corrected by qualified personnel.
•Data Validity: The Pulse Oximeter should NOT be used as a substitute for an ECG
monitor. The oximeter’s Pulse Rate display reflects the pulsatile flowfoundat the patient
extremity connected to the sensor. This rate can be affected by many factors and may
occasionally be “frozen.”
•Care should be exercised to assure continued peripheral perfusion distal to the SpO2
sensor site after application.
•Data Validity: Do NOT attach a sensor distal to a blood pressure cuff. Valid data
CANNOT be processed when the cuff is inflated. Attach the sensor to the limb opposite
to the site used for the blood pressure cuff.
•Data Validity: Inaccurate SpO2and/or Pulse Rate measurements can be caused by any
of the following:
• Incorrect application or use of a sensor
• Significant levels of dysfunctional hemoglobins such as
carboxyhemoglobin or methemoglobin
• Significant levels of indocyanine green, methylene blue, or other
intravascular dyes
• Exposure to excessive illumination such as surgical lamps -especially ones with
a xenon light source, or direct sunlight
• Excessive patient movement, venous pulsations, electrosurgical
interference
•Do Not apply Y-Sensor tapes or wraps so tightlythat circulation is restricted. Inspect site
often for adequate circulation - at least once every four hours. When applying sensors
take note of patient’s physiological condition. For example, burn patients may exhibit
more sensitivity to heat and pressure and therefore additional consideration such as more
frequent site checks may be appropriate.
Warning
Indicates a potentially harmful condition
that can lead to personal injury.
!

Cautions
Patient Safety
2
Rev. 02
Model 515B/C
User’s Manual
5
Cautions
• Do not operate the Model 515B/C when it is wet due to spills or condensation.
• Do not operate the Model 515B/C if it appears to have been dropped or damaged.
• Never sterilize or immerse the monitor in liquids.
• Do not sterilize or immerse sensors except as directed in this manual.
• Excessive tension should not be applied to the sensor cable.
• Do not store the monitor or sensors at temperatures less than 14 °F (-10 °C) or greater
than 131 °F (55 °C).
• Do not operate the monitor or sensors at temperatures less than 50 °F (10 °C) or greater
than 104 °F (40 °C).
• Federal (U.S.A.) law restricts this device to sale, distribution, or use by or on the order
of a licensed medical practitioner.
• Overstretching the pulse oximeter finger sensor can damage the sensor and potentially
affect pulse oximeter readings. Do not stretch the fingersensor open beyond the limit for
which it was designed. Overstretchingcan be prevented: avoid opening the sensorby any
means other than squeezing the grips; DO NOT force the sensor onto large objects such
as a bedrail.
Caution
Indicates a condition that may lead to
equipment damage or malfunction.

2 Patient Safety
Cautions
6 Model 515B/C
User’s Manual Rev. 02
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Rev. 02 Model 515B/C User’s Manual 7
3
Front and Rear Panel Illustrations
POWER button - Press to turn the monitor
on or off.
AC indicator - Green when the monitor is
connected to AC power and rear panel
power entry module switch is set to “|”
(ON). Also indicates the battery is charging.
Audio key - Press to toggle two minute
silence, and reset alert conditions (when
active). Press and hold for audio disable.
Battery icon - Green when operating on bat-
tery with a charged battery, orange when
battery power is diminished, flashes red
when battery power is at a critical low.
Pulse Key - Sets pulse rate alert limits when
used with the keys. Press and hold
to set auto alert limits.
Finger probe icon -Flashes red when no
probe is connected or the probe is off the
patient. Red for any sensor errors which
occur during monitoring.
SpO2key - Sets saturation alert limits when
used with the keys. Press and hold
to set auto alert limits.
Hand icon - Yellow when monitor is search-
ing for valid signal and data is being held.
Increase/decrease keys - Press to set pulse
and alert audio level. Sets alert limits when
used in conjunction with SpO2and Pulse
keys. Press and hold to control graphics dis-
play contrast on Models 515C (Model 515B
does not have graphics display option).
Audio disabled icon - Flashes yellow when
the audio has been disabled.
Two minute silence indictor - Illuminates
yellow when the audio has been muted for
two minutes.
Saturation and pulse rate displays - Satura-
tion and pulse rate values will appear. Status
messages will appear if necessary, see
“Troubleshooting” on page 33. Arrows indi-
cate alert status or that alerts are being set.
Signal bar - Pulses with respect to moni-
tored pulse rate. Amplitude corresponds to
signal strength.
ALERT BAR SENSOR INPUTWAVEFORM DISPLAY ON MODEL 515C ONLY

3 Front and Rear Panel Illustrations
8 Model 515B/C
User’s Manual Rev. 02
Ground stud - Use to connect monitor’s chassis to earth
ground.
Rear panel power switch - Set to “|” allows AC mains
to power monitor, set to “O” switches AC mains power
off.
Voltage select/fuse compartment - Sets mains operating
voltage and houses mains fuses.
Power cord entry - Plug power cord into this receptacle.
Use only hospital grade three wire plugs for connection
via supplied power cord.
Ground stud - Use to connect monitor’s chassis to earth
ground.
Rear panel power switch - Set to “|” allows AC mains
to power monitor, set to “O” switches AC mains power
off.
Voltage select/fuse compartment - Sets mains operating
voltage and houses mains fuses.
Power cord entry - Plug power cord into this receptacle.
Use only hospital grade three wire plugs for connection
via supplied power cord.
AC Power cord: The AC power line cord shipped with monitors for North America is a Hospital Grade, SJT style cord with
a 120 VAC plug. All power line cords shipped with monitors for Europe are the European style with a 220-240 VAC plug.
All other style power line cords, as required by the country of destination, are provided by the distributor of that country.

Rev. 02 Model 515B/C User’s Manual 9
4
Preparing For Use
Monitor Power Up
NOTE: Before using the monitor for the first time, attach the line cord to the rear panel power
entry module, then connect to a proper AC mains outlet. Set the rear panel power switch to “|”
(ON), check that the front panel icon is illuminated. Allow the battery to charge for 12
hours. See “Long Term Storage” on page 11.
1. Plug the connector end of a SuperBright™ series sensor or extension cable
into the front panel connector of the monitor. The sensor will “click” into place
when properly seated.
NOTE: To disconnect the saturation sensor from the monitor, press the latch release lever
on the sensor connector and pull the connector straight back and away from the monitor.
DO NOT twist the connector.
2. If the monitor is to be operated from the AC line, plug the power cord into a
properly grounded three wire outlet and set the rear panel power switch to the
SuperBright™
SERIES CONNECTOR
PRESS DOWN ON LATCH RELEASE
THEN PULL OUT

4 Preparing For Use
Monitor Power Down
10 Model 515B/C
User’s Manual Rev. 02
ON (|) position. The green AC indicator on the front panel will illuminate to
show that AC current is reaching the monitor and charging the battery.
3. Press the front panel power key . The monitor will power up in the following
sequence:
• An audible series of beeps will be produced.
• All displays and LEDs will briefly illuminate.
• The monitor will perform a self test, then the revision level will appear in the saturation
display, the model number “515” will appear in the pulse rate display, and a beep will
coincide with a flash of the alert bar..
• The monitor will enter normal operating mode. With the sensor disconnected, or
connected but not applied to a patient, the SpO2and pulse rate windows will
display “- - -.”
4. Ensure that the monitor is operating in accordance with the above listed steps
before applying the sensor to the patient.
Monitor Power Down
1. To turn the Model 515B/C off, press the key.
Pressing the front panel power key will turn the monitor on/off. The green ACindicator will stay
illuminated signifying that although the monitor is off, AC mains is still connected to the
monitor.
2. To disconnect AC mains power, set the rear panel power switch to OFF (O).
Check that the front panel icon is not illuminated.
NOTE: Removing the AC mains power will not charge the battery. See “Battery Operation” on
page 11.
REAR PANEL POWER SWITCH
AC POWER CORD

Battery Operation
Preparing For Use
4
Rev. 02
Model 515B/C
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11
Battery Operation
The Model 515B/C uses battery power if the line cord is disconnected or the rear panel power
switch is OFF (O). The monitor can operate for up to 8 hours while powered from its internal
battery (fully charged battery). The battery is charging only when the monitor is connected to
AC power, the rear panel power switch is ON (|), and the front panel icon is green.
NOTE: Excessive alerting reduces battery life when operating on battery power.
When the monitor is operating on battery power, and the battery is sufficiently charged, the
battery icon will be green. Should the battery power run low the icon will turn orange. If
the AC line is not connected and the monitor continues to run, the battery will become exhausted
and the icon will begin flashing red, the monitor will sound an audible alert then shortly turn
itself off.
NOTE: This alert cannot be silenced by pressing the key. The monitor must be
connected to AC power to silence the alert condition and recharge the battery.
If the monitor is allowed to continue operation while the battery is in the exhausted state, the
displays will blank out and the audible tone will stop. Reconnect the monitor to the AC line to
recharge the battery. The battery will be fully recharged in 12 hours.
Long Term Storage
If the monitor has not been used or powered by AC mains for an extended time1(3 months or
more) allow the battery to charge for 12 hours before use. The monitor may not power up on
battery power if the battery is not sufficiently charged.
To charge the battery, connect the AC mains and set the rear panel power switch ON (|). Check
that the front panel icon is green. Allow the battery to charge for 12 hours to ensure a fully
charged battery in the event that battery power is required.
1. The internal battery may slowly discharge over long periods of non use.

4 Preparing For Use
Battery Operation
12 Model 515B/C
User’s Manual Rev. 02
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