Model 511 Users Manual

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ii Model 511 User’s Manual

Rev. 01

Manual Revision History

Section i

Rev. 01

Manual Revision History 21-July-93

Release at revision 00.

01-Mayr-96

Revision 01 (R-N389). Includes Addendums A through D from revision 00. Single patient use sensor information included.

MOdel 511 User’s Manual

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Section ii

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. Contact the Novametrix Technical Service Department, at the numbers listed below, to arrange for warranty repair and to receive a Repair Order Number prior to returning any equipment to Novametrix. 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 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  1993, 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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Section ii Guarantee

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Model 511 User’s Manual

Section ii

Contents

Manual Revision History ... iii Guarantee ... iv Contents ... vi Introduction ... 1 Principles of Operation ... 1 Indications and Usage ... 2

Patient Safety ... 3 Warnings ... 3 Cautions ... 4

Illustrations ... 5 Front Panel Illustration ... 5 Display Illustrations ... 6

Monitor Operation ... 7 Battery Installation ... 7 External DC Supply ... 7 Power On/Off ... 8 Display Illumination and Pulse Beep Options ... 8 Audible Alarms... 9 Saturation Auto Alert Limits ... 9 Battery Life ... 10 Select and Apply a Sensor to the Patient ... 10 Monitoring Saturation and Pulse Rate ... 10 Alerts... 11 Status Messages and Numbers... 11

SpO2 Sensors ... 13 Finger Sensor ... 13 Finger Sensor Quick Check ... 14 Y-Sensor... 15 Y-Sensor Application using Y-Strip Tapes... 15 Y-Sensor Application using Ear Clip ... 17 Y-Sensor Quick Check ... 18 Single Patient Use SpO2 Sensors... 19 Instructions for Use:... 19

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Section ii Contents

Connecting the sensor: ... 19 Sensor Application ... 21 Single Patient Use SpO2 Sensor Quick Check... 22

Serial Communication Option ... 23 Connecting a sensor to the Model 511... 23 Connecting the Model 511 for serial communication ... 24 NOVACOMM1 Interface ... 25 Trend Dump ... 25 Date and Time ... 26 Setting Date and Time... 27 Clear Trends ... 27 Exit Command ... 27

Cleaning & Sterilization ... 29 Model 511 Monitor ... 29 Finger Sensor ... 29 Y-Sensor ... 29 Y-Strip Tapes... 30 Ear Clip ... 30

Specifications ... 31 General... 31 Oxygen Saturation (SpO2)... 31 Pulse Rate ... 31 General Specifications ... 31

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Section 1

Introduction This manual describes the use and operation of the Model 511 Pulse Oximeter, from Novametrix Medical Systems Inc. The Model 511 is a lightweight, easy to use, pulse oximeter that provides reliable measurement and displays for functional pulsatile oxygen saturation (SpO2) and pulse rate. The monitor is powered from four standard AA size alkaline batteries, or may be connected to an optional external power source for continuous mains operation. Numerical SpO2 and Pulse Rate information is presented on a liquid crystal display (LCD). A pulsatile signal activity bar, battery strength indicator, and general alarm indicators are also displayed on the LCD. The Model 511 controls include a power on/off switch that also controls display illumination, and an alarm key that enables/disables audible alarms, and sets alert limits. Model 511 monitors (Cat. No. 6416-00) are available with a serial communications option which allows patient trend information to be downloaded into the Novametrix NovaCARD Data Archive System or other communicating devices. Interfacing between the communicating device and the monitor is via a simple cable connection. See “Serial Communication Option” on page 23 for more information.

Principles of Operation The Model 511 measures oxygen saturation and pulse rate with sensors that contain red and infrared light sources, called LEDs. Since oxygen saturated blood absorbs different amounts of light at each wavelength (red and infrared) as compared to unsaturated blood, the amount of light absorbed by the blood in each pulse can be used to calculate oxygen saturation. The light energy from red (660 nm) and infrared (940 nm) LEDs 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, called a photodiode, on the opposing side of the sensor. The data received at the photodiode is sent back to the monitor where it is split into its red and infrared components, digitized, processed by a microprocessor chip, and finally displayed as a numerical value for oxygen saturation and a plethysmogram. The Model 511 is calibrated to display “functional” saturation. This differs from the “fractional” saturation value displayed by most co-oximeters. Functional saturation represents the amount of oxyhemoglobin as a percentage of the hemoglobin that can be

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Section 1 Introduction

oxygenated. Dysfunctional hemoglobins (COHb and METHb) are not included in the measurement of functional saturation. Calculating Functional Oxygen Saturation

Functional Saturation =

HbO2 = Fractional Hemoglobin HbO2 COHb = Carboxyhemoglobin 100 - (COHb + METHb) METHb = Methemoglobin

Pulse Rate is calculated by measuring the time interval between the peaks of the infrared light waveform. The inverse of this measurement is displayed as pulse rate. The Model 511 must be used in conjunction with OxySnap SuperBright™ saturation sensors.

Indications and Usage The Model 511 Pulse Oximeter is intended to be used for monitoring of oxygen saturation and pulse rate. The Model 511 is designed to monitor all patient areas including adult, pediatric and neonatal.

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Section 2

Patient Safety For maximum patient and operator safety, the following are recommended; • Failure of Operation: If the monitor fails to respond as described, do not use it until the situation has been corrected by qualified personnel. • Keep the Model 511 and its accessories clean. • Do not operate the Model 511 when it is wet due to spills or condensation. • Do not operate the Model 511 if it appears to have been dropped or damaged. • Care should be exercised to assure continued peripheral perfusion distal to the SpO2 sensor site after application. Do NOT attach an SpO2 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.

Warnings Warning Indicates a potentially harmful condition that can lead to personal injury.

!

• Explosion Hazard: Do NOT use the Model 511 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 Model 511 off before cleaning it. Do NOT use a damaged sensor or one with exposed electrical contacts. Do not use with a damaged external power source or one with a damaged cord. Refer servicing to qualified service personnel. • Failure of Operation: If the monitor fails to respond as described, do not use it until the situation has been corrected by qualified personnel. • Patient Safety: Care should be exercised to assure continued peripheral perfusion distal to the SpO2 sensor site after application. • Data Validity: As with all pulse oximeters, inaccurate SpO2 and Pulse Rate values may be caused by; • Incorrect application or use of a sensor • Significant levels of dysfunctional hemoglobin; carboxyhemoglobin or methemoglobin • Significant levels of indocyanine green, methylene blue, or other intravascular dyes (continued next page)

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Section 2 Patient Safety

• 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

Cautions Caution Indicates a condition that may lead to equipment damage or malfunction. • Do not operate the Model 511 when it is wet due to spills or condensation. • Do not operate the Model 511 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. • No tension should be applied to any 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 32° F (0° C) or greater than 130° F (54.4° C). • Caution: Federal (U.S.A.) law restricts this device to sale, distribution, or use by or on the order of a licensed medical practitioner.

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Section 3

Illustrations Front Panel Illustration

Front Panel Illustration

SpO2

beats/min

SATURATION

PULSE RATE

%

Saturation and Pulse Rate display identifiers

Display, see next section

511

Pulse Oximeter

Audible Alert Enable/disable Key Power On/Off control

DC Input Jack

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Section 3 Illustrations

Display Illustrations Typical display

%

Saturation display (0-100) Pulse Rate display (30-250) Pulse Activity Bar (16 bars) Audible Alert Disabled Icon Battery Indicator (3 levels) Full Half Low

Typical alert condition display

% Displays “blanked” (dashes) Message displayed as needed

SENSOR OFF PATIENT

All displays illuminated

Status number displayed as needed

%

UNIT/SENSOR ERROR REPOSITION SENSOR SENSOR OFF PATIENT SENSOR DISCONNECT

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Section 4

Monitor Operation Battery Installation The Model 511 operates on four (4) 1.5 volt “AA” alkaline batteries. Other battery types should not be used with the Model 511. WARNING: Use of improper batteries may present a risk of fire or explosion.

Top of monitor

To install batteries into the monitor: 1. Locate the battery compartment cover on the back side of the monitor. 2. Press the “OPEN” area of the compartment cover, slide the cover in the direction indicated by the arrow, and remove the cover. 3. Install new batteries according to the “+” and “-” symbols on the bottom of the battery compartment and on each battery. WARNING: Alkaline batteries may explode or leak if recharged, inserted improperly or disposed of in a fire. Do not open batteries. 4. Slide the battery cover back into place. The cover latches into place when properly seated.

Bottom of monitor

External DC Supply The Model 511 can be powered by an external DC supply. The supply plugs into the small DC power jack located on the lower right side of the monitor. The external supply draws its power from the mains. Both 105-130 VAC and 230 VAC (50/60Hz) versions are available. When the external power supply is used, the batteries are disconnected from the monitor internally, however the battery icon displays a fully charged condition. While powered from the external supply the battery icon does not reflect the condition of the batteries. When changing operation from the external supply to battery (external supply disconnected) allow the monitor to run for one minute, after which the icon will reflect the true battery charge. WARNING: Use only Novametrix supplied external power supplies. The use of other external power sources may jeopardize patient safety, or may damage the Model 511.

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Section 4 Monitor Operation

Power On/Off 1. To turn the monitor on, press and hold the power control. A tone sounds to verify audio is functional, the monitor performs a system self-test, all display segments are briefly illuminated, the software version is displayed, the number “1” will be displayed in the alert triangle, it will then sequence through to “4”. Release the power control key when the desired number is displayed (illumination/pulse beep options). Reference the next section “Display Illumination and Pulse Beep” for an explanation on the options available. If the power control key is pressed, but not held the monitor will power up as described above and will default to selection of “1” for the illumination/pulse beep options (both OFF). SpO2 and pulse rate information will be displayed within 20 seconds of power up, provided the sensor is properly applied to the patient prior to power up or prior to the completion of any monitor self test. 2. To turn the monitor off, press the power control.

Display Illumination and Pulse Beep Options The Model 511 is supplied with a display illumination option, this is designed for better viewability under low ambient lighting conditions. A pulse beep option is also available, this will emit a tone with each pulse detected by the monitor. These options are selected or deselected at power up by holding the power control key until the desired option combination number is displayed, then releasing the power control key to select that number. There are four possible options in regards to display illumination and pulse beep when powering on the Model 511. The four options will appear in sequence in the status field as numbers one through four, these are identified below: Option Number

Illumination

Pulse Beep

1

Illumination OFF

Pulse Beep OFF

2

Illumination OFF

Pulse Beep ON

3

Illumination ON

Pulse Beep OFF

4

Illumination ON

Pulse Beep ON

1. To select one of the four display illumination/pulse beep options press and hold the power control key when the monitor is off. The monitor will power up as described in “Power On/Off” on page 8. The status number field will display “1” inside the alert triangle, it will then change to “2” and sequence through to “4”. If the power control key is still held after the “4” is displayed the monitor will shut off. 2. To select the desired option release the power control key when the appropriate number is displayed inside the alert triangle. 3. To select another option, press the power control to turn the monitor off. Press and hold the power control to turn the monitor back on and select another option number.

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Audible Alarms

Audible Alarms 1. To toggle between enabled and disabled audible alarms, press and release the alarm key. If pressing and releasing the alarm key causes the alarms to be enabled, the monitor shall display the saturation auto alert limit settings (in the SpO2 and pulse rate displays) for three seconds, beep once, and turn off the alarm icon. The alarm display icon will not be displayed while audible alarms are enabled. All visible alerts continuously active for longer than 10 seconds will cause an unlatched audible alarm to sound. Display showing alert limits when audible alert is enabled

%

Alert limits shown for 3 seconds (default values shown here) NOTE: Disabling and re-enabling the audible alarms will reset the ten second delay clock when an alert condition exists. If pressing and releasing the alarm key causes the alarms to be disabled, the monitor shall beep once, and turn on the alarm icon. The alarm display icon will illuminate as a warning that the audible alarms are disabled. Typical display with audible alert icon displayed

%

Audible alert icon shown when audible alert is disabled NOTE: With the audible alarms disabled, the audible alarm will not sound under any alert condition.

Saturation Auto Alert Limits 1. To set alert limits, press and hold the alert key for more than 2.5 seconds. The monitor will beep twice if new limits are set (based on valid SpO2 values). If no SpO2 is displayed, the monitor will use default limits and will beep three times. The Model 511 will display the high limit in the SpO2 display and the low limit in the pulse rate display for three seconds. The monitor will then return to normal operation. NOTE: Setting alert limits automatically enables the audible alarms.

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Section 4 Monitor Operation

2. To display limits without setting new limits if audio is enabled, press and release the alarm key twice. The first press turns off the alarms and the second turns them back on and causes the high and low limits to be displayed for three seconds. The monitor will then return to normal operation. 3. To display limits without setting new limits if the audio is disabled (audible alert icon visible), press and release the alarm key. The high and low limits will be displayed for three seconds before the monitor returns to normal operation. Press and release the alarm key to disable the audible alarms.

Battery Life The Model 511 displays a battery icon to indicate: •

fully charged batteries, over 4 hours of battery life

•

less than 4 hours of battery life

•

indicates less than 2 hours of battery life

•

(flashing) less than 15 minutes of battery life

When the battery voltage reaches the 2 hour level , the battery is very low. As the battery reaches near depletion, the battery icon will flash at a rate of once per second, and the alert audio will sound, this alert tone cannot be muted (even if alerts are disabled). Continued use of the monitor at this point will result in the monitor shutting itself off. NOTE: The above information is based upon normal monitoring conditions (e.g. sensor on patient, new alkaline batteries). Use of non-alkaline, previously used alkaline, or rechargeable alkaline batteries will affect the battery life times. Prolonged use of the backlight can significantly reduce overall battery life. The battery icon may appear fully charged for the first minute after power up, after which it will reflect the true battery charge. NOTE: When operating from the external power supply the battery icon does not reflect the condition of the batteries. See “External DC Supply”.

Select and Apply a Sensor to the Patient Refer to Section 5.

Monitoring Saturation and Pulse Rate Once the Model 511 is powered on and a sensor is connected to the monitor and properly applied to the patient, numerical SpO2 and Pulse Rate values appear on the monitor’s display. A “pulse activity bar”, derived from the pulsatile signal, is also displayed. The monitor automatically adjusts the activity bar’s length to produce an easily visible display. Verify the pulse activity bar reflects the patient’s pulse. The bar should show regular rhythmic movement. Erratic or non-rhythmic pulse bar activity may indicate a poorly positioned or applied sensor, or may be indicative of excess patient movement at the sensor site. Check the sensor site and if necessary, attempt to reduce patient movement. Violation of the upper or lower saturation auto alert limits shall immediately cause a “H” or “L” to flash within the borders of the display alarm icon, even if the icon itself is disabled.

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Model 511 User’s Manual

Alerts

If the Model 511 cannot detect “valid” saturation data with which to update the display, the previous contents of the display shall be “held”. Should the display be held for more than ten seconds, a “-” character will start to flash within the borders of the display alarm icon, even if the alarm icon itself is disabled. If the Model 511 cannot detect valid pulsatile data from the sensor within sixty seconds, the saturation and pulse rate displays will blank out (display “--” and “---” respectively). If the display is held longer than ninety seconds the Model 511 will emit an audible unlatched alarm (if enabled) and REPOSITION SENSOR along with the number 9 will appear in the display. If at any time the monitor processes valid data with which to update the display, the “-” will stop flashing, the display will be updated, the timer reset to zero (seconds), and the audible alarm, if active, will be reset.

Alerts Status Messages and Numbers The Model 511 will display status messages and related status numbers under certain conditions:

%

Typical status message and number display

Message displayed as needed

SENSOR OFF PATIENT

Status number

The following table lists the conditions that cause status messages to be displayed. Summary of status messages and numbers.

Model 511 User’s Manual

Message

Number Condition

Sensor Disconnect Sensor Off Patient Reposition Sensor

1 2 3

Reposition Sensor

4

Reposition Sensor Reposition Sensor

5 6

Unit/Sensor Error

7

Unit/Sensor Error

8

Reposition Sensor

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Sensor not connected to monitor. Sensor not applied to the patient. Low signal strength. Pulse strength as detected by the sensor is too small for proper monitor operation. Insufficient light. Sensor placed on a site too thick (or opaque) for adequate light transmission. Pulse out of range. Pulse must be 30-250 bpm inclusive. Light Interference. Ambient light sources (sunlight, warming lights, etc.) are interfering with sensor operation. Shield sensor from these light sources. Sensor fault. Remove sensor from use and contact qualified service personnel. Monitor fault. Record the error number that appears in the pulse rate display. Remove the monitor from use and contact qualified service personnel. Bad signal, monitor not receiving valid signals from sensor. May be caused by excessive motion, cardiac arrhythmia or other situations leading to poor signal. Check patient status, reposition sensor.

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Section 4 Monitor Operation

All status conditions except for Unit/Sensor Error will reset automatically once the condition is corrected. Unit/Sensor Error conditions are latching conditions-that is you must replace the sensor for a sensor fault, or turn the Model 511 off and fix the problem before the monitor fault is reset.

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Section 5

SpO2 Sensors The Model 511 Pulse Oximeter requires OxySnap SuperBright SpO2 Sensors. WARNING: Connect only Novametrix OxySnap SuperBright saturation sensors to the Model 511. DO NOT use other sensors or accessories with the Model 511. Before connecting to the patient or to the Model 511, ensure sensors are physically intact, with no broken, frayed or damaged components. Ensure the connectors are clean and dry, with no signs of contamination or corrosion. Do not use a broken or damaged sensor or one with wet, contaminated or corroded connectors. To attach an OxySnap SuperBright sensor to the Model 511: 1. Align the arrows on the OxySnap connectors and press the connectors together.

OxySnap Connector

Sensor

Model 511

2. To disconnect, grasp the connectors at the finger grips and pull them apart.

Finger Sensor The Finger Sensor is intended for adult fingers and not designed for neonatal or pediatric applications. OxySnap Finger Sensor

Before applying the sensor to the patient, verify the sensor is physically intact, with no broken/frayed wires or damaged parts. Ensure the connectors are clean and dry, with no signs of contamination or corrosion. Do not use a broken or damaged sensor or one with wet, contaminated or corroded connectors.

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