Novametrix 515B, 515C User manual
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
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. Printe d in U.S.A.
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 SpO
sensor information added, use with software version 04.
2
Rev. 02
Model 515B/C
User’s Manual
ii
[This page intentional ly bl ank.]
iii Model 515B/C
User’s Manual Rev. 02
G
Guarantee
Equipment manufactured or distributed by Novametrix Medical Systems Inc., is fully
guaranteed, covering materials and work manship, for a period of one yea r from the date of
shipment, except for certain disposable products and produ cts 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 shipme nt must be filed promp tly with the transp ortation 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 equip ment without following
specific operating instructions will void this guarantee and release Novametrix from any further
guarantee obligations.
Service Department
For factory repair service, call toll free
1-800-243-3444
In Connecticut, call Collect (203) 265-7701
Telex 956-054
Facsimile (203) 284-0753
Caution: Federal (U.S.A.) law restrict s this de vice to sal e, distrib ution, or u se by or on th e order
of a licensed medical practitioner.
Copyright 1995, 1996, Novametrix Medical Systems In c. 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.
Rev. 02
Model 515B/C
User’s Manual
iv
Service Policy
Novametrix Medical Systems Inc. will provide Warranty Service Support to its customers
within 48 hours of receiving a telephone re quest for technical support. Th is 48 hour period
begins once a service request is placed through the Factory Technical Support Department in
W allingford, Connecticut. No vametrix pro vides factory direct technical supp ort 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 (203) 26 5-7 701 . Aft er hours technical support reques ts (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 a ny product found to be defective during the warran ty 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” an d 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 w arranty repairs should the y 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 Suppor t Department can provide techn ical product support at a le v el
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.
v Model 515B/C
User’s Manual Rev. 02
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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
SpO2 and 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
6SpO2 Sensors ...........................................................................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
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Y-Sensor Quick Check ..................................................................... 29
Single Patient Use SpO
Single Patient Use SpO
Single Patient Use SpO
Sensors ... .. ................ ............................ ...29
2
Sensor Application ................................... 30
2
Sensor Quick Check ................................. 32
2
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 SpO
Ear Clip ....................................................................................... 36
Battery Maintenance ................................ .........................................36
Mains Voltage Configuration ........ .................. .................. .. ...............37
Fuse Replace me n t ........ ............... ............................. .................. 37
Changing the Mains Voltage Setting .................................... ......38
Sensors ................36
2
9 Specifications ...........................................................................41
Pulse Oximeter ................................................................................. 41
Principle of Operation ................................................................. 41
SpO
(Oxygen Saturation) ..........................................................41
2
Pulse Rate ..................................................................................41
Sensors ..... ......... ...... ......... ......... ......... ...... ......... ......... ......... ...... . 41
Plethysmogram (Model 515C only) ......... .. ....................... ..........41
General Specifications ......................................................................41
Alerts ....... ........ ....... ......... ......... ........ ....... ......... ......... ......... ...... ... 41
Display ........................................................................................ 42
Physical ...................................................................................... 42
Electrical ..................................................................................... 42
vii Model 515B/C
10 Accessories .............................................................................. 43
User’s Manual Rev. 02
1
Functional Saturation =
HbO
2
100 - (COHb + METHb)
HbO
2
= Fractional Hemoglobin
COHb = Carboxyhemoglobin
METHb = Methemoglobin
Description
This manual is written for users of the Novametrix Model 515B o r 515C Pulse Oximeter. The
Model 515B/C
saturation (SpO
battery or from the AC Mains.
Principles of Operation
The Model 515B/C measures oxygen saturati on using sensors th at 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 M odel 515B/C
“fractional” saturation value displayed by m ost co-oximeters . Functional s aturation is defined
as:
provides reliable continuous m easurement, display, and alerts for oxygen
) and pulse rate. The monitor can be powered from its rechargeable internal
2
is calibrated to display “functional” saturation. This differs from the
This can be considered to re present the amount of oxyhem oglobin 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 val ues are updated once each second. Presence of a pulse
is indicated visibly by a bar graph di splay , a plethy smogram graphic dis play (Model 515C onl y),
and audibly by a “beep.”
The Model 515B/C
“Accessories” on page 43 for a list of available sensors and accessories.
Rev. 02
must be used in c onjunction with SuperBright™ Sensors. Se e
Model 515B/C
User’s Manual
1
1
Description
Trademark Acknowledgments
Trademark Acknowledgments
SuperBright, Y-STRIP and Y-SENSOR are trademarks of Novametrix Medical Systems Inc.
2 Model 515B/C
User’s Manual Rev. 02
2
Patient Safety
Pulse oximetry is a non-invasive method of monitoring the oxygen saturation of arterial blood.
Pulse oximeters display oxygen saturation of fu nctional hemo globin and ther efor e the accurac y
may be interfered with by carboxyhemoglobin or other dyshemoglobins present in significant
concentrations. Oxygen satura tion 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 1 0 µA at 120 V, 60 Hz. Patient
isolation is greater than 10 M Ω, 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 ho spital’s engineering
department.
Indications and Usage
The M odel 515B/C is intended to be used for monitoring functional oxy gen 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
not intended for any other purpose.
NOTE: Components of this product and its associated accessories which may have patient
contact are free of latex.
is
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Model 515B/C
User’s Manual
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2
Patient Safety
Warnings
!
Warnings
Warning
Indicates a potentially harmful condition
that can lead to personal injury.
• 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 turn the oximeter off, and re move the AC power cord
before cleaning it. Do NOT use a damaged sensor or one with 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 flow found at 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 SpO
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 SpO
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 tightly that 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.
and/or Pulse Rate measurements can be caused by any
2
2
4 Model 515B/C
User’s Manual Rev. 02
Cautions
Caution
Indicates a condition that may lead to
equipment damage or malfunction.
Cautions
Patient Safety
• Do not operate the Model 515B/C when it is wet due to spills or condensation.
• Do not operate the Model 515B/C
• 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 f inger sensor op en beyond the limit for
which it was designed. Overstretching can be prevented: avoid opening the sensor by any
means other than squeezing the grips; DO NOT force the sensor onto large ob jects such
as a bedrail.
if it appears to have been dropped or damaged.
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Patient Safety
Cautions
[This page intentional ly bl ank.]
6 Model 515B/C
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3
Front and Rear Panel Illustrations
ALERT BAR SENSOR INPUTWAVEFORM DISPLAY ON MODEL 515C ONLY
AC indicator - Green when the monitor is
POWER button - Press to turn the monitor
on or off.
Audio key - Press to toggle two minute
silence, and reset alert conditions (when
active). Press and hold for audio disable.
Pulse Key - Sets pulse rate alert limits when
used with the keys. Press and hold
to set auto alert limits.
SpO
key - Sets saturation alert limits when
2
used with the keys. Press and hold
to set auto alert limits.
connected to AC power and rear panel
power entry module switch is set to “|”
. Also indicates the battery is charging.
(ON)
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.
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 monitor ing.
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 SpO
keys. Press and hold to control graphics display contrast on Models 515C (Model 5 15B
does not have graphi cs disp l a y opti on) .
Saturation and pulse rate disp lays - Saturation and pulse rate values will appear. Status
messages will appear if necessary, see
“Troublesh ooting ” on p age 33 . Arro ws ind icate alert status or that alerts are being set.
Rev. 02
and Pulse
2
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.
Signal bar - Pulses with respect to moni-
tored pulse rate. Amplitude corresponds to
signal strength.
Model 515B/C
User’s Manual
7
3
Front and Rear Panel Illustrations
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 po wer 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.
Voltage select/fuse compartment - Sets mains operating
voltage and houses mains fuses.
Rear panel power switch - Set to “|” allows AC mains
to power monitor, set to “O” switches AC mains po wer
off.
AC Po we r co rd: Th e AC power line cord shipped with m o nito rs f or North Am er ica is a Hosp ital 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.
8 Model 515B/C
Power cord entry - Plug po wer cord into this receptacle.
Use only hospital grade three wire plugs for connection
via supplied power cord.
User’s Manual Rev. 02
4
SuperBright™
SERIES CONNECTOR
PRESS DOWN ON LATCH RELEASE
THEN PULL OUT
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.
Rev. 02
NOTE: To disconnect the saturation sensor from the monitor , press the latc h release lever
on the sensor connector and pull the connec tor 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
Model 515B/C
User’s Manual
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