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Novametrix Medical Systems OXYPLETH 520A User Manual

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OXYPLETH
User's Manual
Pulse Oximeter
Model 520A
January 18, 2002
Catalog No. 5693-23-04
Copyright  2001, 2002. Novametrix Medical Systems Inc.
5 Technology Drive, Wallingford, Connecticut, U.S.A. 06492. All rights reserved.

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Summary of Contents for Novametrix Medical Systems OXYPLETH 520A

  • Page 1 ® OXYPLETH User’s Manual Pulse Oximeter Model 520A January 18, 2002 Catalog No. 5693-23-04 Copyright  2001, 2002. Novametrix Medical Systems Inc. 5 Technology Drive, Wallingford, Connecticut, U.S.A. 06492. All rights reserved.
  • Page 2 Copyright 2002 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.
  • Page 3 Revision History 02-May-92 Release Version. 23-Apr-93 Revision 01, based on version 2.4 software. 01-Apr-98 Revision 02, version 2.7 software and addenda added. 11-Jun-99 Revision 03, R-N676 18-Jan-02 Revision 04, R-N1000 ® OXYPLETH User’s Manual Rev. 04...

  • Page 4: Table Of Contents

    Contents Introduction .............1 Indications and Usage .
  • Page 5 Timers ............29 IABP Mode .

  • Page 6: Introduction

    Section 1 Introduction ® The OXYPLETH Pulse Oximeter Monitor, Model 520A is a lightweight, easy to use pulse oximeter, designed to be used in a variety of clinical settings. It provides reliable measurement, display, and alerts, for functional pulsatile oxygen saturation (SpO ) and pulse rate.
  • Page 7 Section 1 SpO2 Principles of Operation [This page intentionally blank.] ® OXYPLETH User’s Manual Rev. 04...

  • Page 8: Patient Safety

    Section 2 Patient Safety ® input for the OXYPLETH Pulse Oximeter , Model 520A, is electrically isolated. Patient leakage current flowing from the instrument to ground is limited to less than 10 µA at 120 VAC, 60 Hz. Patient isolation is greater than 10 MΩ, 2500 VAC rms at 60 Hz. For patient and operator safety, observe the following warnings, cautions and notes.

  • Page 9: Cautions

    Section 2 Cautions Cautions CAUTION Indicates a condition that may lead to equipment damage or malfunction. ® • Do not operate OXYPLETH when it is wet due to spills or condensation. ® • Do not operate OXYPLETH if it appears to have been dropped or damaged. •...

  • Page 10: Symbols

    Patient Safety Symbols Symbols Symbol Description Patient Isolation Identifies patient isolation connection as type BF. Attention Consult manual for detailed information. Separate collection Ensure that spent batteries are collected separately when disposed of. Found on the internal battery. Refer to qualified service personnel when battery replacement is required.
  • Page 11 Section 2 Symbols [This page intentionally blank.] ® OXYPLETH User’s Manual Rev. 04...

  • Page 12: Monitor Basics

    Section 3 Monitor Basics AC Operation The rear panel power input module must be set to the proper voltage setting and the proper fuses must be installed for safe AC Mains (line cord) operation. The module should indicate the proper voltage setting (115 VAC for use in the U.S.A.) Refer to the ®...

  • Page 13: Powering Up The Monitor

    Section 3 Powering up the monitor Powering up the monitor To turn the monitor on or off, press POWER Ensure the monitor operates as stated below before applying a sensor to the patient. • All displays and indicators illuminate briefly •...

  • Page 14: Setting The Contrast

    Monitor Basics Setting the Contrast store the waveform to the NovaCARD™. Pressing will bring up the patient ID menu. The softkey ERASE will erase the card. Pressing will return to real time display. Setting the Contrast Press the (contrast) key to adjust the display for optimum viewing. To adjust the display colors and brightness, Set Display Brightness on page 38.

  • Page 15: Pulse "Beep" Volume

    Section 3 Pulse “Beep” Volume Pulse “Beep” Volume An audible “beep” occurs with each detected pulse beat. The time between beeps indicates the pulse rate; the pitch of the beep varies with the SpO value. The beep pitch decreases with each one-digit drop in SpO .

  • Page 16: Alerts

    Section 4 Alerts Overview The Model 520A monitor provides audible and visible limit alerts for oxygen saturation, and pulse rate. and Pulse Rate each have separate alert limits and limit alerts. Audible and visible alerts may be generated for reasons including violated alert limits, improper sensor placement, interference from electrosurgical units or excessive motion, ambient light interference or low signal strength.

  • Page 17: Auto Alert Limits

    Section 4 Auto Alert Limits If the parameter returns within its limits before 10 seconds elapse: Assuming the 10 SECOND ALERT LIMIT DELAY is ON (the default setting): • indicator, the violated limit display and the alert message stop flashing If the limit alert lasts for more than 10 seconds: (Or the 10 SECOND ALERT LIMIT DELAY is OFF.) •...

  • Page 18: Setting Alert Limits Manually

    Alerts Setting Alert Limits Manually Pulse Rate Auto Alert Limits The pulse rate high auto alert limit is set at 25% more than, and the low auto alert limit is 25% less than, the pulse rate value that was displayed before was selected (maximum = 249 and minimum AUTO = 30).

  • Page 19: Alert Limit Settings-Retained/Defaults

    Section 4 Alert Limit Settings—Retained/Defaults Press ALERTS OPTIONS Press until Press Press MENU NEXT LATCH 1 reappears (3 sec) ALERT OPTIONS 1 appears ALERTS LATCHED ALERTS OPTIONS SETUP appears 1 reappears Press OPTIONS appears NOTE The Latched or Unlatched alert setting remains in effect until changed, even if the monitor is turned off and on.

  • Page 20: Alert Bar-Latched/Unlatched/Off

    Alerts Alert Bar—Latched/Unlatched/Off Press MENU Press NEXT until Press DELAY Press YES or NO Press RUN to (3 sec) ALERT OPTIONS return to the 2 appears 10 SEC LIMIT ALERTS OPTIONS Main Menu SPO2 SETUP ALERT DELAY 2 reappears OPTIONS appears appears NOTE...

  • Page 21: Audio Off/Mute

    Section 4 Audio Off/Mute Press ↑ ↓ to Press MENU Press ALERT Press RUN to Press AUDIO increase or return to the SYSTEM SET ALERT VOL- decrease the Main Menu SET AUDIO FEA- OPTIONS alert volume set- TURES appears appears appears ting (01-07) Audio Off/Mute...
  • Page 22 Alerts Faults, Alerts & Errors Alert Limit Messages PULSE-HIGH High alert limit for pulse rate has been violated. PULSE-LOW Low alert limit for pulse rate has been violated. PULSE OUT OF RANGE Pulse rate is less than 30 bpm or is greater than 250 bpm. SpO2-HIGH High alert limit for saturation has been violated.
  • Page 23 Section 4 Faults, Alerts & Errors 1. Monitor is running on battery power and the battery power has been depleted. Connect line cord to AC Mains power source and set the rear BATTERY VERY LOW panel switch to “|” PLUG IN AC POWER 2.

  • Page 24: Pulse Oximetry Sensors

    Section 5 Pulse Oximetry Sensors ® The OXYPLETH monitor supports Novametrix SuperBright™ SpO Finger and Y-Sensors™, and Single Patient Use sensors. Finger sensor Remove: Y-Sensor™ Press latch release Insert: and pull sensor out. Push in. Do not twist. Do not twist. Sensors may be connected and removed with the monitor off or on.

  • Page 25: Y-Sensor

    Section 5 Y-Sensor™ Y-Sensor™ The reusable Y-Sensor™ is designed for use on all patients from adults to neonates. Inspect site often for adequate circulation - at least once every four hours. NOTE Ensure the sensor heads are opposite each other through the tissue. This prevents the sensor from being placed on a site that is too thick for proper operation.
  • Page 26 Pulse Oximetry Sensors Y-Sensor™ Using Foam Wraps To use the foam wraps; Insert sensor: Press each “button” through the blue side of the foam wrap. Remove liner: If using an adhesive foam wrap, pull tabs as indicated to remove liner. Peel off liner Apply: Wrap around the site with the blue side facing the skin.
  • Page 27 Section 5 Y-Sensor™ Using Y-Strip™ and Butterfly Tapes Head Insert sensor: With instructions facing up, press blue sensor buttons Button through holes in liner. Liner (Adhesive) The spacing of the holes on the Neonatal/Pediatric Y-Strip™ allows customization to different sized sites; first and second for pediatric toes or fingers, first and third for neonatal feet, hands and pediatric feet.

  • Page 28: Single Patient Use Sensors

    Pulse Oximetry Sensors Single Patient Use Sensors Using the Ear Clip To use the ear clip: Slide each Y-Sensor™ head into an Ear Clip receptacle with the blue button facing outwards. Open the clip by squeezing its ends and Sensor Blue apply it to the ear.
  • Page 29 Section 5 Single Patient Use Sensors Position the sensor so that the tape does not extend over the space between the fingers or toes. This insures there will be no light transmission through this space. The tab on the Neonatal/Pediatric sensor is removable, allowing shortening for a better fit. Reapply the tab to secure the sensor in place.
  • Page 30 Pulse Oximetry Sensors Single Patient Use Sensors Sensor Quick Check A quick functional check of basic sensor operation. Y-Sensor™: With the sensor connected to the monitor but not applied to the patient, position the sensor heads so they face each other and the red light shines on the detector. Is PROBE OFF PATIENT displayed? Finger Sensor: Is PROBE OFF PATIENT displayed when the sensor is connected to the monitor but not applied to the patient? Apply the sensor to your finger.
  • Page 31 Section 5 Single Patient Use Sensors [This page intentionally blank.] ® OXYPLETH User’s Manual Rev. 04...

  • Page 32: Spo 2 And Pulse Rate

    Section 6 and Pulse Rate Display Averaging The oxygen saturation value is determined in part by the selected SpO display averaging. Averaging affects only the numerical display and not the plethysmogram. A short averaging time provides faster response to changing patient conditions while a longer averaging time helps eliminate the interference from motion or other artifact.

  • Page 33: Waveform Autosize

    Section 6 Waveform Autosize Waveform Autosize allows continual automatic adjustment of the magnitude of the plethysmogram. : locks the plethysmogram vertical scaling—making the waveform magnitude reflect relative signal strength. Press MENU Press SIZE Press ON or OFF Press RUN to return (3 sec) to the Main Menu WAVEFORM AUTO-...

  • Page 34: Spo Timers

    and Pulse Rate Timers Special alert delay Display held timer Bad signal alert Permanent mute status Disabled Enabled Enabled Enabled Waveform autoscale Alert bar latched Alerts latched Allow audio off 10 second alert delay Serial interface NovaCard NovaCard NovaCOM1 NovaCOM1 Keyclick volume Select Mode To select a mode of operation:...
  • Page 35 Section 6 Timers To verify or change the current setting of the Display Held Timer: allows the timer to display in the Message Center. prevents the timer from displaying. Press MENU Press NEXT Press HELD Press ON or OFF Press (3 sec) return to the SPO2 TIMERS...

  • Page 36: Iabp Mode

    and Pulse Rate IABP Mode Typically, conditions such as continuous, excessive motion, cardiac arrhythmia, or other physiologic conditions providing extremely poor plethysmogram signals, will cause the BAD SIGNAL TIMEOUT message and alerts to activate. How the Timer and Delay functions interact: The Bad Signal Timer feature works in conjunction with the Display Held Timer and Special Alert Delay.
  • Page 37 Section 6 IABP Mode Making IABP Mode Available IABP Mode must be made available from the Main Menu. The setting is retained even if the monitor is turned on and off. To allow IABP Mode to be selected from the Main Menu: .

  • Page 38: Trend Memory

    Section 7 Trend Memory NOTE: Uninterrupted patient monitoring continues while trends are displayed. Any latched alert that occurs while viewing trend data causes the Main Menu to reappear. If no keys are pressed for 5 minutes, the Main Menu replaces the trend display. Trend information for SpO and Pulse Rate are maintained.

  • Page 39: Histogram Trend Display

    Section 7 and Dual Trend Displays 1 data point per 128 seconds (approx. 2 minutes) in an 8 hour trend 1 data point per 192 seconds (approx. 3 minutes) in an 12 hour trend Because of the data compression, data at any horizontal pixel may look like a vertical bar. The upper extent of the bar represents the maximum value;...

  • Page 40: Erase Trend Memory

    Trend Memory Erase Trend Memory data is tabulated on the left side of the display and Pulse Rate data is displayed on the right half. For each of six categories, a bar graph is drawn showing the percentage of the total time the parameter was within the category.
  • Page 41 Section 7 Trend Print [This page intentionally blank.] ® OXYPLETH User’s Manual Rev. 04...

  • Page 42: Advanced Monitor Features

    Section 8 Advanced Monitor Features NOTE always displays the Main Menu. (previous) move through the menus one level at NEXT PREV a time. The Main Menu will reappear if no key is pressed for one minute (except when trends are displayed, then the time-out is extended to five minutes).

  • Page 43: Menu System Lockout

    Section 8 Menu System Lockout Set Display Color Display colors can be changed, coupled with brightness and contrast settings, to provide a very vis- ible display over a wide range of lighting conditions. Press MENU (3 sec.) Press NEXT until Press DISP and the Select display color MONITOR OPTIONS 1...

  • Page 44: External Devices

    Section 9 External Devices Serial Output Interface ® OXYPLETH can communicate with other devices using the built-in RS232 compatible serial port. Several serial communications modes are available. They include: • Full Format Mode: Default mode used for general purpose data collection. •...

  • Page 45: Novacom1 Interface Mode

    Section 9 NOVACOM1 Interface Mode In Full Format Mode, the monitor can communicate with a personal computer or data logging system equipped with an RS232 interface. Full Format Mode is the factory default serial interface. To view or alter the current Full Format Mode settings: Press MENU Press NEXT Press PREV...

  • Page 46: Analog Output Module

    External Devices Analog Output Module Analog Output Module The optional Analog Output Module, Catalog No. 9622-01, provides the necessary analog output voltages for use with ® analog instruments such as strip chart recorders. OXYPLETH does not directly support analog devices. The Analog Output Module provides analog output voltages, via a 9-pin connector, and RS232C pass through, via a 25-pin connector, so that both analog and serial devices can be used...

  • Page 47: Rear Panel Rs232C Pinout

    Section 9 Rear Panel RS232C Pinout Rear Panel RS232C Pinout The 25-pin RS232C output connector is described below. Pin 2 RX (Receive In) Pin 3 TX (Transmit Out) Pin 5 RS232 (High Reference) Pin 6 CTS (Clear To Send (input)) Pin 7 GNDI (Interface ground) Pin 14...

  • Page 48: Printing

    Section 10 Printing Selecting a Specific Printer The monitor must be set to the appropriate printer interface. When Printer Interface Mode is selected, (print) softkey is added to the Main Menu and to the Trend Options menu. Press to return PRNT to the Main Menu.

  • Page 49: Create A Printout

    Section 10 Create a Printout Setting the DIP switches: [ DIP SW settings mode ] The printout of the current settings is followed Dip SW-1 by the prompt: 1 (OFF) : Input = Serial 2 (ON ) : Printing Speed = High “Continue? : Push On-line SW”...
  • Page 50 Printing Create a Printout Displayed Trend Printout To create a Displayed Trend Printout from the graphical or histogram trend display: Press TRND to display Press EXPAND to Press NEXT Press PRINT trend data select 12, 8 or 2 hours, or 30 minutes TREND OPTIONS PRINTOUT STARTED is appears...
  • Page 51 Section 10 Create a Printout Compressed Trend Printout To create a Compressed Trend Printout: Press PRINT Press TRND Press ALL Select NONE, 1/2, 1/4 or PAGE SELECT PRINT PRINT TREND appears SELECT PRINT OPTIONS is displayed. COMPRESSION appears : up to 12 sheets of standard paper NONE : up to 6 sheets of paper : up to 3 sheets of paper...

  • Page 52: Interpreting Printer Output

    Printing Interpreting Printer Output Interpreting Printer Output Header Each printout starts with a header that identifies the oximeter (Model 520A) and printer type (SEIKO, ThinkJet or Model 315). The date and time of the printout is furnished by the monitor’s calendar/clock. Space is then provided to enter patient information.
  • Page 53 Section 10 Interpreting Printer Output Histogram Data A histogram based on the printed portion of trend memory is printed after the graphical data for all trend printouts. Total Elapsed Time: Time trending was active; the total time covered by the printout. Non-Monitoring Time: Time spent in a Probe Off Patient, Connect SpO Probe or other non-monitoring condition.

  • Page 54: Cleaning & Sterilization

    Section 11 Cleaning & Sterilization The monitor and sensors can be cleaned by wiping down with solutions such as 70% isopropyl alcohol, 2% glutaraldehyde, or 10% bleach solution. Wipe down with a water dampened clean cloth to rinse. Let dry before use. Perform a “Quick Check”...
  • Page 55 Section 11 [This page intentionally blank.] ® OXYPLETH User’s Manual Rev. 04...

  • Page 56: Specifications

    Section 12 Specifications ® Specifications for the Novametrix OXYPLETH Pulse Oximeter, Model 520A, are listed for informational purposes only, and are subject to change without notice. Oxygen Saturation (SpO • Range: 0-100% • Accuracy: 80-100% ± 2%, 0-79% unspecified (Approximately 68% of the observations are within the accuracy claim.) •...
  • Page 57 Section 12 General Specifications [This page intentionally blank.] ® OXYPLETH User’s Manual Rev. 04...

  • Page 58: Accessories

    Section 13 Accessories Catalog No. Description ® 5693-00 OXYPLETH Pulse Oximeter, Model 520A, with choice of sensor SE NS OR S and CA BL ES 8776-00 SuperBright™ Finger Sensor (10 ft. sensor cable) 8791-00 SuperBright™ Y-Sensor™ (10 ft. sensor cable) 9169-00 Y-Sensor™...
  • Page 59 Section 13 Catalog No. Description SEN SO R M A NAG EM E NT PLA N S Select a Finger or Y-Sensor™ Plan for each Pulse Oximeter. The plan you select determines the length of coverage—36 or 60 months. How the Plans Work: Included in each Plan are TWO sensors—one for immediate use, the other one for back-up.
  • Page 60 Accessories Catalog No. Description AC CE SS OR IE S 6064-00 NovaCARD™ Startup Kit (includes 1 each, Writer module, Reader module, SRAM Memory ® Card (128k), and NovaCARD™ for MS-DOS software). NovaCARD™—Computer Archive, Recall and Display—is a hardware/software combination that allows users to transfer patient trend data, user-stored waveforms, and monitored parameter values, from supported Novametrix monitors to a personal computer.
  • Page 61 Section 13 Catalog No. Description BIO M E DIC A L E NG IN EE RI NG S ERV ICE T EST K IT Service Test Kits include items and materials qualified service personnel may require to determine the functional integrity and/or accuracy of the system. ®...

  • Page 62: Menu Trees

    Section 14 Menu Trees ® The OXYPLETH menus are described on the following pages. ® Rev. 04 OXYPLETH User’s Manual...
  • Page 63 OXYPLETH ® Menu Tree Revision 2.8 Software Nov-99 ERASE STORED TRENDS ? POWER ON TREND RETAINED ERASING TREND PLEASE WAIT MAIN MENU TREND ERASED message center ALRT TRND MENU DRAWING TREND PLEASE WAIT SET ALERT LIMITS ↑ ↓ AUTO TREND MMMDD HH:MM:SS S EXPAN <-...
  • Page 64 OXYPLETH ® Menu Tree Revision 2.8 Software Nov-99 MAIN MENU message center ALRT TRND MENU IABPwill appear only if selected in SpO2 SETUP OPTIONS menu. SYSTEM OPTIONS AUDIO LITE IABP MAIN Toggles Back- MENU light On/Off. SELECT IABP MODE SET AUDIO FEATURES PULSE ALERT PREV...
  • Page 65 message center message center message center ALRT TRND SIZE MENU ALRT TRND PRNT MENU ALRT TRND CARD MENU WAVEFORM AUTO SIZE A serial printer interface must The NOVACARD option must must be turned ON in the be selected in MONITOR be programmed in MONITOR SPO2 SETUP...
  • Page 66 OXYPLETH ® Menu Tree Revision 2.8 Software Nov-99 message center ALRT TRND MENU Press and hold MENU key for 5 seconds SPO2 SETUP OPTIONS SPO2 TIMERS MONITOR OPTIONS 1 MODE IABP SIZE NEXT HELD SPEC NEXT DISP KLCK NEXT Continued next page MAIN MAIN...
  • Page 67 From previous page MONITOR OPTIONS 2 ALERT OPTIONS 1 ALERT OPTIONS 2 CLOCK NEXT LATCH DFLT MUTE NEXT DELAY PREV NEXT Displays SPO2 SETUP OPTIONS menu MAIN MAIN MAIN Previous Menu MENU MENU MENU CALIBRATE RECORDER ALLOW AUDIO OFF ZERO HALF FULL PREV...

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