Users Manual
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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. Printed in U.S.A.
R
Rev. 02
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 SpO2 sensor information added, use with software version 04.
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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. 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 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.
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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 (203) 265-7701. 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.
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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
6 SpO2 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 SpO2 Sensors ... 29 Single Patient Use SpO2 Sensor Application ... 30 Single Patient Use SpO2 Sensor 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 SpO2 Sensors ... 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
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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/C measures 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: HbO2
Functional Saturation =
100 - (COHb + METHb) HbO2 = Fractional Hemoglobin COHb = Carboxyhemoglobin METHb = Methemoglobin 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 by a bar graph display, 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.
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1 Description
Trademark Acknowledgments
Trademark Acknowledgments SuperBright, Y-STRIP and Y-SENSOR are trademarks of Novametrix Medical Systems Inc.
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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.
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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 remove 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 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 SpO2 and/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 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.
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Patient Safety
Cautions
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Cautions
Caution Indicates a condition that may lead to equipment damage or malfunction. • 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 finger sensor open 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 objects such as a bedrail.
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2 Patient Safety
Cautions
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Front and Rear Panel Illustrations
WAVEFORM DISPLAY ON MODEL 515C ONLY 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. SpO2 key - Sets saturation alert limits when used with the keys. Press and hold to set auto alert limits. Increase/decrease keys - Press to set pulse and alert audio level. Sets alert limits when used in conjunction with SpO2 and Pulse keys. Press and hold to control graphics display contrast on Models 515C (Model 515B does not have graphics display option). Saturation and pulse rate displays - Saturation and pulse rate values will appear. Status messages will appear if necessary, see “Troubleshooting” on page 33. Arrows indicate alert status or that alerts are being set.
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ALERT BAR
SENSOR INPUT
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. Battery icon - Green when operating on battery 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 monitoring. Hand icon - Yellow when monitor is searching for valid signal and data is being held. 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 monitored pulse rate. Amplitude corresponds to signal strength.
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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 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. 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 power off. 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.
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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.
SuperBright™ SERIES CONNECTOR 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. PRESS DOWN ON LATCH RELEASE THEN PULL OUT
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
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4 Preparing For Use
Monitor Power Down
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.
REAR PANEL POWER SWITCH AC POWER CORD
3. Press the front panel power key sequence:
. The monitor will power up in the following
• 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 SpO2 and 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 AC indicator 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.
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Battery Operation
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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.
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Monitor Operation Once an SpO2 sensor is connected to the monitor and properly applied to the patient, the Model 515B/C displays SpO2, pulse rate, and a signal bar that gives qualitative indication of the strength of the pulsatile signal which the monitor is receiving. In the case of the Model 515C, a plethysmogram (pulsatile waveform) will be displayed on the LCD screen. The SpO2 and pulse rate display also indicate status messages and audio levels. These functions are described in detail in this section.
SpO2 and Pulse Rate Displays The measured SpO2 will appear in the display at the upper left of the front panel, the pulse rate in the display at the lower left. The Model 515B/C ensures that only valid pulsatile signals are processed. Bad or invalid data causes alerts to occur and may also cause the displays to show “- - -” and “- - -” in the SpO 2 and pulse rate displays respectively.
SpO2 DISPLAY
PULSE BAR
PULSE RATE DISPLAY
The displays are updated once per second as the monitor is acquiring data. If the monitor cannot detect a regular and rhythmic pulsatile signal for periods longer than 45 seconds, the display will blank out (“- - -” will be displayed in the SpO2 and “- - -” in the Pulse rate displays). If the signal should return (regular and rhythmic pulsatile data detected), then the display will update with the new values.
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