Model 2001 Users Manual May 2000

Guarantee

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 Facsimile (203) 284-0753 World Wide Web: http://www.novametrix.com Internet: [email protected] Copyright© 2000, 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.

Acknowledgments Model 2001, SuperBright, Y-Sensor, and Y-Strip are trademarks (™) of Novametrix Medical Systems Inc. Other trademarks and registered trademarks are owned by their respective companies. The Model 2001 is Year 2000 compliant.

Revision History 25-Feb-00 11-May-00

Release, revision 00 Revision 01 R-N755

Declaration of Conformity with European Union Directive The authorized representative for Novametrix Equipment is: D.R.M. Green European Compliance Services Limited, Oakdene House, Oak Road, Watchfield Swindon, Wilts SN 6 8TD United Kingdom

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Declaration of Conformity with European Union Directive

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Contents Introduction ...1 SpO2 Principles of Operation ...1 Indications and Usage ...2 Symbols ...2 Patient Safety ...3 Warnings ...3 Cautions ...4 Illustrations ...5 Front Panel ...5 Rear and Top Panel ...6 Monitor Basics ...7 AC Mains (Line Cord) and Battery Power ...7 Power Key ...7 Audio Key ...8 ALERT RESET Key ...8 EVENT Key ...9 Contrast Key ...9 The Menu SOFTKEYS ...9 Default Menu Selectable Parameters ...10 Alerts ...11 Overview ...11 Limit Alerts ...11 Auto Alert Limits ...12 Setting Alert Limits Manually ...13 Limit Alerts-Latched/Unlatched ...13 Alert Limit Settings-Retained/Defaults ...14 Alerts-Delayed/Instant ...14 Alert Bar-Latched/Unlatched/Off ...15 Alert Volume ...16 Audio Mute ...16 Faults, Alerts and Errors ...17 SpO2 Sensors ...19 OxySnap™ Connectors ...20 Finger Sensor ...20 Y-Sensor ...21 Single Patient Use SpO2 Sensors ...27 SpO2 and Pulse Rate ...31 SpO2 Display Averaging ...31

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Pulse Rate Display Averaging ... 31 Pulse “Beep” Volume ... 31 Signal Bar ... 32 Plethysmogram Display ... 32 Operating Mode Selection ... 33 SpO2 Timer ... 33 Trend Memory ... 35 Trend Data Compression ... 36 SpO2 and Dual Trend Displays ... 36 Histogram Trend Display ... 37 Erase Trend Memory ... 38 Trend Print ... 38 Trend and NovaCARD Memory Module ... 38 Advanced Monitor Features ... 39 Keyclick Volume ... 39 Display Brightness ... 39 Display Colors ... 39 Menu System Lockout ... 40 Serial Output Interface ... 40 Setting the Clock/Calendar ... 45 Display Monitor Software Revision Level ... 46 Using a Printer ... 47 Selecting the Printer Interface ... 47 Print Formats ... 50 Interpreting Printer Output ... 52 Analog Output Module ... 55 Connecting the Analog Output Module ... 55 Rear Panel RS232C Pinout ... 56 Analog Output Setup ... 56 Maintenance ... 57 Cleaning and Sterilization ... 57 Mains Voltage Configuration ... 58 Specifications ... 61 General ... 61 Oxygen Saturation (SpO2) Section ... 61 Pulse Rate Section ... 61 General Specifications ... 62 Additional Features ... 62 Accessories ... 63 Model 2001 Pulse Oximeter ... 63 Menu Trees ... 67

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Section 1

Introduction

This manual describes the use and operation of the Model 2001 Pulse Oximeter Monitor from Novametrix Medical Systems Inc. Model 2001 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 (SpO2) and pulse rate. The monitor can be powered from the AC Mains (line voltage) or from its rechargeable internal battery. Numerical and waveform information is presented on a bright Cold Cathode Display (CCD) with user adjustable contrast to optimize viewing angles. A simple menu system allows user selection of measurement and display options. Alerts are menu programmable or automatic. Numerical and plethysmogram displays are continually updated. Presence of a pulse is indicated audibly by a user selectable “beep”. Separate 24 hour trends for SpO2 and pulse rate are updated every 8 seconds. In addition, trend “events” and audible alarm status (Audio Off) are stored in trend memory. The monitor is equipped with an RS232 serial output port for easy interfacing to external equipment. An optional Analog Output module provides analog outputs. Per requirements of IEC 601-1, the Model 2001 is classified as class II equipment, with type BF applied part, and an enclosure protection rating of IPX0. The Model 2001 is Year 2000 compliant.

SpO2 Principles of Operation Model 2001 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, such as 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. Model 2001 is calibrated to display “functional” saturation. This differs from the “fractional” saturation value displayed by most co-oximeters. Equation 1. Functional Saturation Calculation

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

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Section 1

Indications and Usage

Functional saturation represents 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 the peaks of the infrared light waveform. The inverse of this measurement is displayed as pulse rate. Model 2001 must be used in conjunction with SuperBright™ saturation sensors. (An INSUFFICIENT LIGHT display message indicates a non-SuperBright™ Sensor may be in use.)

Indications and Usage The Model 2001 Pulse Oximeter Monitor is intended to be used for monitoring oxygen saturation and pulse rate in all critical monitoring environments including ventilatory support and anesthesia. Model 2001 is designed to monitor all patient areas including adult, pediatric and neonatal.

Symbols Symbol

Description Patient Isolation Identifies patient isolation connection as type BF.

!

Attention Consult manual for detailed information. Indicates heavy metal content, specifically lead. Found on the internal battery and monitor enclosure. Refer to qualified service personnel when battery replacement is required. Recyclable item Found on the internal battery. Refer to qualified service personnel when battery replacement is required.

Pb

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Model 2001 User’s Manual

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.

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Section 2

Patient Safety

The SpO2 input for the Model 2001 Pulse Oximeter is electrically isolated. Patient leakage current flowing from the instrument to ground is limited to less than 25 PA at 120 VAC, 60 Hz. Patient isolation is greater than 10 M:, 4000 VAC rms at 60 Hz. The Model 2001 is Year 2000 compliant. 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 Model 2001 and its accessories clean. Do not operate Model 2001 when it is wet due to spills or condensation. Do not operate Model 2001 if it appears to have been dropped or damaged. Connect the line cord only to a grounded hospital-grade outlet. Model 2001 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. Care should be exercised to assure continued peripheral perfusion distal to the SpO2 sensor site after application. Components of this product and its associated accessories which may have patient contact are free of latex. The Model 2001 contains no user serviceable parts. Refer servicing to qualified service personnel. A technical Service Manual (Catalog No. 9400-90) is available for use by technical personnel.

Warnings WARNING

!

Indicates a potentially harmful condition that can lead to personal injury • •

• • • • • •

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Explosion Hazard: Do NOT use Model 2001 in the presence of flammable anesthetics. Use of this instrument in such an environment may present an explosion hazard. Electrical Shock Hazard: Always turn Model 2001 off and remove line cord before cleaning it. Do NOT use a damaged sensor or one with exposed electrical contacts. Refer servicing to qualified service personnel. Do not operate Model 2001 when it is wet due to spills or condensation. Do not operate Model 2001 if it appears to have been dropped or damaged. 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 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:

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Section 2

Cautions

• Incorrect application or use of a sensor • Significant levels of dysfunctional hemoglobin 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 •

•

•

• •

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.” 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. Do NOT apply Y-Sensor tapes or wraps so tightly that the circulation is restricted. Inspect site often for adequate circulation - at least once every four hours. When applying sensors take note of the 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. Do not position the sensor cable in any manner that may cause entanglement or strangulation. The Model 2001 has no protection against the ingress of water.

Cautions CAUTION Indicates a condition that may lead to equipment damage or malfunction. • • • • • •

• • •

•

4

Do not operate Model 2001 when it is wet due to spills or condensation. Do not operate Model 2001 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. 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 the bed rail. Do not store the monitor or sensors at temperatures less than 14q F (-10q C) or greater than 131q F (55q C), 10-95% R.H. non-condensing. Do not operate the monitor or sensors at temperatures less than 50q F (10q C) or greater than 104q F (40q C), 0-90% R.H. non-condensing. Where electromagnetic devices (i.e. electrocautery) are used, patient monitoring may be interrupted due to electromagnetic interference. Electromagnetic fields up to 3V/m will not adversely affect system performance. 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 1

2 3

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4 5 6

16

7

15

8

POWER key. Press to turn on monitor. Low Battery Indicator. Illuminates (red) if monitor powered from battery. Flashes to warn of low battery voltage condition. 3. AC Power Indicator. Illuminates (green) if monitor is connected to AC (Mains) and the rear panel power switch is set to “|”. 4. Two Minute Silence Indicator. AUDIO Illuminates (yellow) when the key is pressed. Alarms silenced for two minutes. AUDIO key. Press and release to turn 5. on/off the two minute silence function. Press and hold to enable the Audio Off feature (unless disabled via Options Menu). Press and release to disable Audio Off. 6. Audio Off Indicator. Flashes (yellow) as a warning that the audible alarms are disabled. ALERT RESET key. Press to disable 7. active alert indicators. Alerts will reactivate if alert condition still exists. 8. Alert Indicator. Flashes (red) when an alert/alarm occurs. Continues to flash until ALERT RESET condition corrected and is pressed.

1. 2.

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9

10

11

13

12

SOFTKEYS. Press software keys 1-5 (left to right) to initiate action listed above each key. 10. Kickstand and bedrail hanger. EVENT key. Press to place an “event 11. marker” into the trend. 12. Red Alert Bar. Flashes (red) when an alert/ alarm occurs. Continues to flash until ALERT RESET condition corrected and is pressed. 13. SpO2 Sensor Input Connector. 14. Contrast key. Press to adjust display for optimum viewing. 15. Waveform or trend data displayed here. 16. Menu Display. Softkey functions and menu messages displayed here. 17. Parameter Numerical Displays. Numerical displays and alert limit settings for measured parameters displayed here. Also display units and special display options noted here.

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Section 3

Rear and Top Panel

Rear and Top Panel

1

2

3

4

5

6

7

10 8 11

12

9

1. 2.

3. 4.

5.

6.

6

Ground symbol: Equipotentiality. Connection to monitor’s chassis. Line Cord Clip: This clip can be set around the line cord strain relief so that the cord cannot be pulled out of the connector. Line Cord Connector: The AC (Mains) line cord attaches to the monitor here. AC Mains Power Switch: With switch in “O” position, AC Mains voltage does not enter monitor. With switch in “|” position, AC Mains voltage allowed into monitor to power unit and/or charge internal battery. Fuse Compartment: The AC (Mains) line fuse(s) are inside this compartment. Pry open with small screwdriver. AC Mains Voltage: The currently selected AC Mains input voltage is identified here.

Model 2001 User’s Manual

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Serial Output Connector: Serial (RS232) data output here for use with RS232 interfaces. A female 25-pin “D” connector serves as the interface connector. 8. Attention: Consult manual for detailed information. 9. Top Cover 10. Carrying Handle: Monitor carrying handle molded into case. 11. Warning Label: Explosion and electrical shock warnings. 12. Patient Isolation Label: The Model 2001 is Type BF equipment.

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Section 4

Monitor Basics

AC Mains (Line Cord) and Battery Power AC Operation The Model 2001 Pulse Oximeter can operate from AC Mains (line cord) power or from its internal battery. 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 "Mains Voltage Configuration" on page 58 if this setting needs to be changed. To operate from AC Mains (line cord) power, plug the line cord into the rear panel power input connector and set the rear panel POWER switch to “|”. Connect the other end of the line cord to a properly grounded three-wire outlet.

Battery Operation Model 2001 can operate for up to three hours while powered from its internal battery (excessive alerting reduces battery life). The monitor is powered from its internal battery whenever the line cord is disconnected or the rear panel POWER switch is set to the “O” (off) position. While on battery power, Model 2001 displays a battery icon to the left of the Signal Bar. indicates a fully charged battery, a half charge, and indicates less than 30 minutes of battery life remain. Note: The battery icon appears fully charged for the first minute after switching to battery power; after that it will reflect the true battery charge. When approximately 15 minutes of battery life remain, the front panel LOW BAT indicator illuminates. Reconnect the monitor to the AC Mains to recharge the battery. The monitor can be operated from the AC Mains while the battery is being recharged. The battery will be fully recharged in 12-15 hours. If the monitor continues operating on battery power while in the low battery state ( illuminated), the battery becomes exhausted and the monitor stops operating. The message BATTERY VERY LOW PLUG IN AC POWER is displayed and a continuous audible tone will sound. The audible tone cannot be silenced, the monitor must be connected to AC Mains for continued operation and to recharge the battery. If the monitor is allowed to continue operation while in the battery exhausted state, the monitor will automatically shut itself off to avoid excessive discharge and damage to the battery.

Power Key •

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If the AC ON icon is illuminated, Model 2001 is connected to AC Mains (line cord) power, the internal battery is being charged, and the monitor uses line power if turned on.

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Section 4

Audio Key

To operate from AC Mains (line cord) power, plug the line cord into the rear panel AC input connector and set the rear panel power switch to “|”. Plug the other end of the line cord to a properly grounded three-wire outlet. •

1.

illuminates when 15 Model 2001 can operate for up to 3 hours on battery power. LOW BAT minutes of battery power remain. If AC ON is not illuminated, the monitor will operate from battery power.

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 briefly1 A “beep” indicates the audio is functional MONITOR PERFORMING SELF TEST message is replaced by the Main Menu Perform “Sensor Quick Check”, refer to "Finger Sensor Quick Check" on page 21, "Y-Sensor Quick Check" on page 27 or "Single Patient Use SpO2 Sensor Quick Check" on page 30 for the appropriate sensor.

2.

Press the

(contrast) key to adjust the display for optimum viewing.

3.

Press YES to erase or press NO to retain stored trend information. “ERASE STORED TRENDS?” is briefly displayed after power on. To keep the trend data from previous monitoring episodes intact, let the menu time out (trend not erased) or press the softkey below the NO menu choice. Press YES to erase the stored trend data.

Audio Key Audible alarms can be silenced in two ways: temporarily or permanently. •

•

AUDIO key. The Two Minute Alarm Silence: Press the (two minute silence) indicator to AUDIO illuminates and audible alarms are silenced for two minutes. After two the left of the minutes, the indicator turns off and audible alarms are again allowed to sound. To cancel the two AUDIO key again and the minute silence before the two minutes have elapsed, press the silence condition will be cancelled. AUDIO key until the Permanent Audio Off: Press and hold the (audio off) indicator to the AUDIO key starts flashing.2No audible alarms will be generated. To cancel the right of the AUDIO key again: it will stop flashing and audible alarms are audio off condition, press the again allowed to sound.

ALERT RESET Key An alert occurs if SpO2 or pulse rate exceeds the displayed alert limits. Alerts are also generated by conditions such as SENSOR OFF PATIENT. When an alert occurs, the (alert) indicator flashes, and violated limit displays, menu center messages and the red alert bar may flash and an alarm may sound. Once the alert condition is fixed, and other flashing displays may continue even though the audible alarms stop.

1 AC ON will not illuminate unless AC line power is connected and the rear panel POWER switch is set to “|”. 2 If AUDIO OFF DISABLED appears when the user activates AUDIO OFF, refer to “Audio Mute” on page 16.

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Monitor Basics

EVENT Key

ALERT RESET key to stop an alert condition that is not currently active. Any alert Press the messages, flashing indicators or audible alarms will be disabled. Currently active alert/alarm conditions will be reset and again become active once the appropriate time-out period has elapsed.

In certain non-monitoring conditions such as CONNECT SPO2 SENSOR or SENSOR OFF PATIENT, ALERT RESET will reset (silence) the audible alarms until monitoring is resumed and the pressing monitor again receives valid signals from the sensor.

EVENT Key EVENT key to place an “event” marker into the monitor’s trend memory. Pressing the Press the EVENT key while in the Main Menu will freeze the waveform for sixty seconds; the message WAVEFORM FROZEN appears on the display. To return to the real time display before the sixty second EVENT softkey in menus other than the Main Menu time out, press the RUN softkey. Pressing the will not freeze the waveform, but the event will be recorded in trend memory. Events are stored in trend memory for use in printouts and trend data examination. The message EVENT MARKED is displayed each time an event is marked from the Main Menu. EVENT key is pressed, the When the Model 2001 is configured for operation with a printer and the message PRINT WAVEFORM? will be displayed for 60 seconds. Pressing the PRNT key during this time will cause a printout of the waveform; this printout will be the 5 seconds proceeding the freezing of the display.

When the Model 2001 is configured for operation with the NovaCARD memory module and the EVENT key is pressed, the message STORE WAVEFORM? will be displayed for 60 seconds. Pressing STORE will store the waveform to the NovaCARD. Pressing ID will bring up the patient identification menu. The ERASE softkey will erase the card. Pressing RUN will return to real time display.

Contrast Key Press the

(contrast) key to adjust the display for optimum viewing.

The Menu SOFTKEYS The Menu Center display area is located just above the five unmarked software keys or “softkeys”. Softkeys perform the action displayed above each key. For example; above the rightmost softkey in the Main (or Base) Menu is a MENU key. Press MENU and new menu and softkey functions are displayed. Press RUN to return to the Main Menu. NOTE: RUN always displays the Main Menu. NEXT and PREV (previous) move through the menus one level at a time. The Main Menu will reappear if no key is pressed for one minute (except if trends are displayed, when the time-out is extended to five minutes).

The Main Menu The Main (or Base) Menu is comprised of the following keys: •

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ALRT - used to set alert limits, either manually or with Auto Alerts.

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Section 4

Default Menu Selectable Parameters

• •

TRND - brings up the trend page menus and displays. MENU - brings up the SYSTEM OPTIONS. Audio volumes, display brightness and SpO2 averaging times can be set here.

The following keys may also appear in the Main Menu: • • •

SIZE - displayed only if WAVEFORM AUTOSIZE set to OFF. Refer to “Waveform Autosize” on page 32. PRNT - displayed only if PRINTER INTERFACE is selected. Refer to “Printer Interface Mode” on page 41. CARD - displayed only if NOVACARD INTERFACE is selected. Refer to “NovaCARD Interface Mode” on page 45.

Default Menu Selectable Parameters Model 2001 retains measurement parameters and system setup information in its memory even while it is turned off. When the monitor is turned back on, the retained settings are restored and will be in effect until they are changed by the user. Model 2001 is shipped from the factory with its operating parameters set to these default values: • • • • • • • • • • • • • • • • •

Alerts: Latched Alert Bar Latched: No Alert Limits: SpO2 100-85, Pulse 150-40 Alert Limits: Retained on start-up Alert Volume: Maximum (07) Allow Audio Off: Yes Averaging: SpO2 - 8 seconds, Pulse Rate - 8 seconds (fixed) Display Brightness: High Display Contrast: Center of range Display Mode: Blue wave on white background; White text on blue background Keyclick Volume: Off (00) Limit Alert Delay: Yes (10 seconds) Menu Lockout: Off Pulse Alert Limits: On Pulse Volume: Off (00) Serial Interface: Full Format Mode Waveform Autosize: On

Returning to Factory Default Settings The user can reset the monitor back to the factory default settings at any time. To return the monitor to its factory default settings; ALERT RESET key.

1.

Turn the monitor on while depressing the

2.

The message PARAMETERS RESET TO FACTORY DEFAULT is displayed. The monitor enters its normal operational mode using the factory default values.

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Section 5

Alerts

Overview This section explains Model 2001 alerts and their possible causes. Model 2001 provides audible and visible limit alerts for oxygen saturation, and pulse rate. SpO2 and Pulse Rate each have separate alert limits and limit alerts.

Definitions Limit Alerts are audible and visible signals from the monitor which are generated in response to SpO2 or Pulse Rate values outside the range of the Alert Limits-the maximum and minimum allowable values for SpO2 and Pulse Rate. Alert Limits are the smaller numbers displayed to the left of the SpO2 and Pulse Rate displays. Model 2001 is very flexible in handling alerts because it provides several alert options. • • • • • • • • •

Alert limits can be adjusted automatically with the Auto Alerts feature or manually from within the menu system. Pulse Rate limits may be turned off. Limit alerts require user action to be reset, but they can be set to automatically reset. Alert limit settings are retained in memory and restored each time the monitor is turned on; the monitor can be set to power up each time using default settings. Audible alerts are delayed 10 seconds from the occurrence of a limit alert; the delay can be eliminated to allow instant activation. Audible alert volume can be adjusted. Audible alerts can be temporarily silenced for two minutes. Audible alerts can be suppressed altogether via the Audio Off feature; furthermore the Audio Off feature can itself be disabled for use in situations where suppressing audible alerts is undesired. The Alert Bar stops flashing automatically if the parameter that caused a limit alert returns within ALERT its limits; the Alert Bar can instead be set to continue flashing until the user presses RESET; the Alert Bar can be turned off altogether.

Audible and visible alerts may also 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. Broken or damaged sensors, extension cables or monitors can also cause alerts to occur.

Limit Alerts If SpO2 or Pulse Rate violates an alert limit setting:

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Section 5

Auto Alert Limits

• • •

The violated alert limit display starts to flash. ALERT RESET key starts to flash. The red (bell-shaped) indicator beside the A message flashes in the Message Center (for example SpO2-LOW)

If the parameter returns within its limits before 10 seconds elapse: Assuming the 10 SECOND ALERT LIMIT DELAY is ON (the default setting): •

The

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.) • •

•

An audible alarm will sound (Two Minute Silence and Audio Off features silence the audio. Refer to “Audio Key” on page 8.) The Alert Bar to the right of the display starts to flash (unless Bar option in the Alert Options menu has been changed. Refer to “Alert Bar-Latched/ Unlatched/Off” on page 15.) The violated limit becomes latched (unless the Latched option in the Alert Options menu has been changed to No. Refer to “Limit Alerts-Latched/Unlatched” on page 13.)

If the parameter returns within limits after 10 seconds of alerting: • •

• •

The audible alarm will turn off The Alert Bar will stop flashing (unless Bar option in the Alert Options menu has been changed. Refer to “Alert Bar-Latched/ Unlatched/Off” on page 15.) If the limits are latched, the indicator and violated limit display continue to flash until the user ALERT RESET key. (This allows the user to determine which limit was violated.) presses the If the limits are unlatched, the indicator and violated limit display stop flashing.

Auto Alert Limits Auto Alerts allow the user to bracket the alert limits based on recent patient data. To set Auto Alert Limits: 1.

The sensor must be applied and the monitor displaying SpO2 and Pulse Rate. NOT ENOUGH DATA TO SET AUTO LIMITS is displayed if AUTO is pressed before sufficient SpO2 and Pulse Rate data is acquired. The limits in this case are not changed.

2.

Press the ALRT softkey and SET ALERT LIMITS appears.

3.

Press the AUTO softkey. The monitor sets the new limit values and displays AUTO ALERT LIMITS SET.

4.

The Main Menu returns automatically.

SpO2 Auto Alert Limits The SpO2 high auto alert limit is set to 5 more than the SpO2 value displayed when the AUTO was pressed (maximum setting =100). The low auto alert limit is set to 5 less than the SpO2 value displayed when AUTO was pressed. (minimum setting = 50).

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Alerts

Setting Alert Limits Manually

For example, if the SpO2=98% when AUTO is pushed, the system will set the upper alert limit to 100 (98+5=103 with max of 100) and the lower alert limit to 93 (98-5=93).

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 AUTO was selected (maximum = 249 and minimum = 30). For example, if the pulse rate=72 when AUTO is pushed, the system will set the upper alert limit to 90 (72+25%=72u1.25=90) and the lower alert to 54 (72-25%= 72u0.75=54).

Setting Alert Limits Manually The user can manually adjust the SpO2 and Pulse Rate alert limits. WARNING: Care should be exercised to ensure clinically reasonable alert limit settings are selected. Novametrix does not recommend the setting of limit values to such a wide span as to effectively render the alert limit feature useless. Once the limit values are properly set, the user should periodically confirm patient status by alternate means and not rely solely on alerts generated when a limit is violated. Alert limit adjustment ranges are: • • •

SpO2 - High 100-55, Low 95-50 Pulse Rate - High 249-35, Low 244-30 Pulse Rate alerts can be turned off if the High limit is raised above 249 or the Low limit is dropped below 30. If the Pulse Rate limits are off, the limits display OFF and no Pulse Rate limit alerts are generated.

To manually set the alert limits: 1.

Press the ALRT softkey and SET ALERT LIMITS appears.

2.

Press SEL (select) to move “ “ to the limit to be changed.

3.

Press n or p to increase or decrease the selected limit. Press and release the arrow keys to change the limit value one digit at a time. Press and hold the arrow keys to make the value change more rapidly. WARNING: Model 2001 will not allow a parameter’s high and low alert limits to be set to within 5 digits of each other. For example, using default values, if the upper Pulse Rate limit is lowered to 44, the Pulse Rate low limit will change from 40 to 39 in order to maintain the 5 digit difference between limits.

4.

Once all limits are set as desired press RUN.

Limit Alerts-Latched/Unlatched Alerts caused by a parameter violating an alert limit setting are normally “Latched”. Once a latched alert is active for 10 seconds, even if the parameter then returns within its limits, the violated alert limit display

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Section 5

Alert Limit Settings-Retained/Defaults

and the indicator continue to flash until the user presses the which parameter caused the alert.

ALERT RESET key. This indicates

Model 2001 also supports “Unlatched” alerts that automatically stop the flashing of the violated alert limit display and the indicator as soon as the alerting parameter returns within its limits. The user ALERT RESET when unlatched alerts are in use. does not have to press the To select Latched or Unlatched alerts: 1.

Press and hold the MENU softkey for 3 seconds. SPO2 SETUP OPTIONS is displayed.

2.

Repeatedly press the NEXT softkey until ALERT OPTIONS 1 appears.

3.

Press LATCH and ALERTS LATCHED appears. The current setting flashes.

4.

Press YES or NO as desired. YES provides latched alerts that require the user to press ALERT RESET to clear them NO provides unlatched alerts that reset automatically without user intervention.

NOTE: Once the choice of Latched or Unlatched alerts is made, that choice will remain in effect, even if the monitor is turned off and on, until changed by the user. 5.

ALERT OPTIONS 1 reappears. Press RUN to return to the Main Menu.

Alert Limit Settings-Retained/Defaults When Model 2001 is powered on, it restores the (Retained) alert limit settings that were in effect when the monitor was last turned off. However, the monitor can be configured to use its (Default) start-up values at each power up instead. To use Retained or Default alert limit settings at power up: 1.

Press and hold the MENU softkey for 3 seconds. SPO2 SETUP OPTIONS is displayed.

2.

Repeatedly press the NEXT softkey until ALERT OPTIONS 1 appears.

3.

Press DFLT (default) and RETAIN ALERT LIMITS appears. The current setting flashes.

4.

Press YES or NO as desired. YES. The monitor powers up using the alert limit settings from the previous use. NO. The monitor powers up using default alert limits: SpO2 100-85, Pulse Rate 150-40.

NOTE: Once the choice of Retained or Default alert limit settings is made, that choice will remain in effect, even if the monitor is turned off and on, until changed by the user. 5.

ALERT OPTIONS 1 reappears. Press RUN to return to the Main Menu.

Alerts-Delayed/Instant When SpO2 or Pulse Rate violates an alert limit, the violated limit display and the indicator start to flash immediately, but the audible alarm and Alert Bar (if enabled) are delayed 10 seconds. This delay

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Model 2001 User’s Manual

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Alerts

Alert Bar-Latched/Unlatched/Off

helps avoid “nuisance” alarms, because the alert will be cancelled if the parameter returns within its limits during that first ten seconds. The 10 second audible and Alert Bar delay can be eliminated if the user desires, and the monitor will activate audible and Alert Bar alerts as soon as an alert limit is violated. Eliminating the delay also has the effect of latching the alert as soon as it occurs. Refer to “Limit Alerts-Latched/Unlatched” on page 13. To select or eliminate the 10 second audible and Alert Bar delay for limit alerts: 1.

Press and hold the MENU softkey for 3 seconds. SPO2 SETUP OPTIONS is displayed.

2.

Repeatedly press the NEXT softkey until ALERT OPTIONS 2 appears.

3.

Press DELAY and 10s LIMIT ALERT DELAY (violation) appears. The current setting flashes.

4.

Press YES or NO as desired. YES. Audible and Alert Bar alerts for violated alert limits are delayed 10 seconds. NO. Audible and Alert Bar alerts occur as soon as an alert limit is violated.

NOTE: Once the Alert Delay setting is decided, that choice remains in effect, even if the monitor is turned off and on, until changed by the user. 5.

ALERT OPTIONS 2 reappears. Press RUN to return to the Main Menu.

Alert Bar-Latched/Unlatched/Off The Alert Bar to the right of the monitor display can be set to operate in three different modes. The Alert Bar can be Latched, Unlatched, or turned off altogether. A “Latched” Alert Bar starts to flash as soon as a limit alert occurs. If the alerting parameter returns within its limits before 10 seconds elapse, the Alert Bar turns off. If the alert condition lasts for more than 10 seconds, the flashing Alert Bar becomes “latched” and will continue to flash, even if the alerting ALERT RESET key.* parameter returns within its limits, until the user presses the An “Unlatched” Alert Bar starts flashing 10 seconds after an alert limit violation occurs and turns off as soon as the alerting parameter returns within its limits, regardless of the duration of the alert. The Alert Bar will not flash under any condition if it has been turned “Off”. (bell shaped) indicator to the left of the NOTE: The red flash whenever a limit alert occurs. Unlike the Alert Bar, the

ALERT RESET key will always

cannot be turned off.

To turn the Alert Bar on (latched or unlatched) or off: 1.

Press and hold the MENU softkey for 3 seconds. SPO2 SETUP OPTIONS is displayed.

2.

Repeatedly press the NEXT softkey until ALERT OPTIONS 2 appears.

3.

Press BAR and ALERT BAR LATCHED appears. The current setting flashes.

4.

Press YES or NO or OFF as desired. *However, if Unlatched Alerts are selected (See “Limit Alerts-Latched/Unlatched” on page 13), the Alert Bar will turn off once the alerting parameter returns within its limits.

Rev. 01

Model 2001 User’s Manual

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