Model 2001 Users Manual August 2005

Respironics Hospital Division Customer Service: 1-800-345-6443 or 724-387-4000 Respironics Novametrix, LLC 5 Technology Drive Wallingford, CT U.S.A. 06492

Respironics California, Inc. 2271 Cosmos Court Carlsbad, CA USA 92011

Declaration of Conformity with European Union Directive The Authorized Representative for this equipment is: Respironics Deutschland Gewerbestrasse 17 82211 Herrsching Germany Tel: +49 8152 93060

Guarantee Equipment manufactured or distributed by Respironics, 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. Respironics reserves the right to perform guarantee service(s) at its factory, at an authorized repair station, or at the customer’s installation. Respironics’ obligations under this guarantee are limited to repairs, or at Respironics’ 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 Respironics from any further guarantee obligations. Customer Service & Product Support: USA and Canada Phone 1-800-345-6443 Customer Service Fax 1-800-886-0245 Product Support Fax 1-724-387-5236 International Phone 724-387-4000 Fax 724-387-5012 service@respironics.com clinical@respironics.com www.respironics.com

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 Copyright © 2005, Respironics, Inc. This document contains information which is proprietary and the property of Respironics 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 Respironics.

Service Policy The Respironics Hospital Services Group provides depot service for monitors and 24-hour a day access to technical support through its Technical Support Department in Murrysville, PA. (Outside the U.S., primary technical support is handled through our qualified international sales and service distributors.) Contact the Technical Support Department by telephone toll free at 800-345-6443 ext 5; by facsimile at 724-387-5236; or by e-mail at service@respironics.com for technical inquiries or clinical@respironics.com for clinical inquiries After hours telephone 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. After hours facsimile and e-mail requests will be answered the next business day. It is suggested that any person calling in for technical support have the equipment available for product identification and preliminary troubleshooting. Respironics 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. Exchanged materials are expected to be returned to Respironics within 10 days for full credit. Return materials should be cleaned as necessary and sent directly to Respironics referencing the RA number provided. (Transferring return materials to a local sales or dealer representatives does not absolve you of your return responsibility.). 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. Please contact Technical Support for information on these additional programs and services: •Technical & Clinical Training •Test Equipment and Test Kits •Service Contract / Parts Insurance Plans •On-Site Service Support

Trademarks and Patents Novametrix is a registered trademark and MARS, SuperBright, Y-Sensor, Y-Strip, NovaCARD and OxySnap are trademarks (™) of Respironics, Inc. and its affiliates. The Model 2001 monitor and its sensors and accessories are covered by the following US patents: 5,190,038 5,398,680 5,448,991 5,820,550 5,999,834 5,891,026 6,073,038 6,149,481. Other patents pending.

Revision History 25-Feb-00 11-May-00 15-Aug-00 4-Apr-01 8-Aug-01 18-Jan-02 11-Apr-03 30-Jan-04 06-Apr-04 23-Jul-04 02-Aug-05

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Release, revision 00 Revision 01 R-N755 Revision 02 R-N790 Revision 03 R-N886 Revision 04 R-N929 Revision 05 R-N1000 Revision 06 CO_N0242 Revision A, CO_N0883 Revision B, CO_N1038 Revision C, CO_N1278 Revision D, CO_N2381

Rev. D

Contents Introduction ...1 Indications and Usage ...1 SpO2 Principles of Operation ...1 Patient Safety ...3 Warnings ...3 Cautions ...4 Notes ...4 Symbols ...5 Monitor Basics ...7 AC Operation ...7 Battery Operation ...7 Powering up the monitor ...8 Audio ...8 Alert Reset ...8 Marking Events ...8 Setting the Contrast ...9 Menu Softkeys ...9 Alert Audio Volume ...9 Pulse “Beep” Volume ...10 Default Operating Parameters ...10 Returning to Factory Default Settings ...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 ...15 Audio Off/Mute ...16 Faults, Alerts & Errors ...16 Pulse Oximetry Sensors ...19 Finger Sensor ...19 Y-Sensor™ ...20 Single Patient Use Sensors ...23 SpO2 and Pulse Rate ...27 Display Averaging ...27 Signal Bar ...27

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Plethysmogram Display ... 27 Operating Mode Selection ... 27 Trend Memory ... 29 Display Trend Memory ... 29 Trend Data Compression ... 29 SpO2 and Dual Trend Displays ... 30 Histogram Trend Display ... 30 Erase Trend Memory ... 31 Trend and NovaCARD™ Data Archive System ... 31 Trend Print ... 31 Advanced Monitor Features ... 33 Advanced Feature Settings ... 33 Menu System Lockout ... 35 External Devices ... 37 Serial Output Interface ... 37 Chart Recorder Mode ... 38 NOVACOM1 Interface Mode ... 38 NovaCARD™ Interface Mode ... 38 Flexport ... 39 Analog Output Module ... 39 Nurse Call Option ... 40 Rear Panel RS232C Pinout ... 41 Printing ... 43 Selecting the Printer Interface ... 43 Create a Printout ... 44 Interpreting Printer Output ... 47 Maintenance ... 49 Cleaning & Disinfection ... 49 WEEE/RoHS Recycling Directives ... 50 Specifications ... 51 Oxygen Saturation (SpO2) ... 51 Pulse Rate ... 51 General Specifications ... 51 Accessories ... 53 Menu Trees ... 57

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Section 1

Introduction

The 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.

Indications and Usage The Model 2001 is intended to be used for monitoring oxygen saturation and pulse rate in all critical monitoring environments including ventilatory support and anesthesia. It is designed to monitor all patient areas including adult, pediatric and neonatal. 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 indicated for use by technically skilled clinical personnel.

SpO2 Principles of Operation The Model 2001 measures oxygen saturation and pulse rate with sensors that contain red and infrared light sources, called Light Emitting Diodes (LEDs). Because 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 2001 is calibrated to display “functional” saturation. This differs from the “fractional” saturation value displayed by most co-oximeters.

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

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. The Model 2001 must be used in conjunction with SuperBright™ saturation sensors. A CHECK SENSOR SITE display message indicates a non-SuperBright™ Sensor is in use.

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Section 1

SpO2 Principles of Operation

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Section 2

Patient Safety

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 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.

Warnings

!

WARNING Indicates a potentially harmful condition that can lead to personal injury • 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. • 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. • Patient Safety: Extreme care should be exercised with all patients, especially 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 is 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. • 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.

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Section 2

Cautions

Cautions CAUTION Indicates a condition that may lead to equipment damage or malfunction. • 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. • Keep Model 2001 and its accessories clean. • Tension should not be applied to the 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 14° F (-10° C) or greater than 131° F (55° C), 10-95% relative humidity, non-condensing. • Do not operate the monitor or sensors at temperatures less than 50° F (10° C) or greater than 104° F (40° C), 0-90% relative humidity, 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. • Caution: Federal (U.S.A.) law restricts this device to sale, distribution, or use by or on the order of a licensed medical practitioner.

Notes NOTES A point of particular interest or emphasis intended to provide more efficient or convenient operation. • 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 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 • Use of an IABP. • This product and its associated accessories which have patient contact are free of latex. • After the life cycle of the equipment and accessories has been met, disposal should be accomplished following national and local requirements. • 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.

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Patient Safety

Symbols

Symbols Symbol

Description Patient Isolation Identifies patient isolation connection as type BF.

!

Attention Consult manual for detailed information. Compliant with the WEEE/RoHS recycling directives. Separate collection. Ensure that spent batteries are collected separately when disposed of. 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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Indicates heavy metal content, specifically lead. Found on the internal battery and monitor enclosure. Refer to qualified service personnel when battery replacement is required.

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Section 2

Symbols

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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 Model 2001 Service Manual if this setting needs to be changed. If AC ON indicator is illuminated, Model 2001 is connected to AC Mains (line cord) power, the internal battery is charging, and the monitor uses line power if turned on. 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.

ground power input connector

voltage AC Mains power switch

Battery Operation The monitor can operate for up to three hours 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. If the monitor is allowed to continue operation while in the battery exhausted state, it will automatically shut off to avoid excessive discharge. 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. Battery Life - Indicators and messages: Battery icons:

- fully charged - half charge - less than 30 minutes

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LOW BAT

15 minutes of battery power remains. Reconnect the monitor to AC Mains to recharge the battery.

BATTERY VERY LOW PLUG IN AC POWER

Displays with a continuous audible tone. Connect to AC Mains for continued operation and to recharge the battery (12-15 hours).

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Section 3

Powering up the monitor

Powering up the monitor 1.

To turn the monitor on or off, press POWER. Ensure the monitor operates as stated below before applying a sensor to the patient. • • •

2.

All displays and indicators illuminate briefly1 A “beep” indicates the audio is functional MONITOR PERFORMING SELF TEST message is replaced by the Main Menu

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 or press the key below the NO menu choice. Press YES to erase the stored trend data.

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

•

(two minute silence) indicator to the left Two Minute Alarm Silence: Press the AUDIO key. The of the AUDIO illuminates and audible alarms are silenced for two minutes. To cancel the silence condition before two minutes have elapsed, press the AUDIO key again. Permanent Audio Off: Press and hold the AUDIO key until the (audio off) indicator to the right of the AUDIO key starts flashing2. No audible alarms will be generated. To cancel the audio off condition, press the AUDIO key again.

Alert Reset Press the ALERT RESET key to cancel an alert condition that is not currently active. Any alert messages, flashing indicators or audible alarms will be disabled. Currently active alert/alarm conditions will be reset and again become active when the appropriate time-out period has elapsed. In certain non-monitoring conditions such as CONNECT SPO2 SENSOR or SENSOR OFF PATIENT, pressing ALERT RESET will reset (silence) the audible alarms until monitoring is resumed and the monitor again receives valid signals from the sensor.

Marking Events Press the EVENT key to place an “event” marker into the monitor’s trend memory. Pressing 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 seconds has elapsed, press the RUN softkey. The message EVENT MARKED is displayed each time an event is marked from the Main Menu. NOTE: Pressing the EVENT softkey in menus other than the Main Menu will not freeze the waveform, but the event will be recorded in trend memory. When the Model 2001 is configured for operation with a printer and the EVENT key is pressed, the message PRINT WAVEFORM? will be displayed for 60 seconds. Press PRINT for a printout of the waveform in the 5 seconds preceding the frozen display. When the Model 2001 is configured for operation with the NovaCARD™ Data Archive System and the

EVENT key is pressed, the message STORE WAVEFORM? will be displayed for 60 seconds. Pressing STORE

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 AUDIO OFF is activated, refer to “Audio Off/Mute” on page 16.

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Monitor Basics

Setting the Contrast

will store the waveform to the NovaCARD™. Pressing ID will bring up the patient ID menu. The ERASE softkey will erase the card. Pressing RUN 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, See Set Display Brightness on page 34.

Menu Softkeys The Menu Center display area is located just above the five unmarked “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 when trends are displayed, then the time-out is extended to five minutes).

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

ALRT - used to set alert limits, either manually or with Auto Alerts. TRND - brings up the trend page menus and displays. MENU - brings up the SYSTEM OPTIONS. Audio volumes, display brightness, Infant Mode and averaging times can be set here.

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

PRNT - displayed only if PRINTER INTERFACE is selected. See Selecting the Printer Interface on page 43. CARD - displayed only if NOVACARD INTERFACE is selected. See NovaCARD™ Interface Mode on page 38.

Alert Audio Volume To adjust the audible alert volume: NOTE: to silence Alert audio, See Audio on page 8.

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Press MENU

Press AUDIO

Press ALERT

SYSTEM OPTIONS appears

SET AUDIO FEATURES appears

SET ALERT VOLUME appears

Press to increase/decrease value, 01-07

Press RUN to return to the Main Menu

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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 SpO2 value. The beep pitch decreases with each one-digit drop in SpO2. If the SpO2 value drops more than 35% below the SpO2 high alert limit setting, the beep remains at the lowest pitched level. To vary the pulse beep volume:

Press MENU

Press AUDIO

Press PULSE

SYSTEM OPTIONS appears

SET AUDIO FEATURES appears

SET PULSE VOLUME appears

Press to increase/decrease value, 00-07 (00 is off)

Press RUN to return to the Main Menu

Default Operating Parameters The monitor 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. The monitor is shipped from the factory with operating parameters set to these default values: • • • • • • • • • • • • • • • • •

Alerts: Latched Alert Bar: Unlatched Alert Limits: SpO2 100-85, Pulse 150-40 Alert Limits: Retained on start-up Alert Volume: Level “03” Allow Audio Off: Yes Averaging: 4 seconds (selectable) 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: Novacom1 Infant Mode: Off

Returning to Factory Default Settings To return the monitor to factory default settings:

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1.

Turn the monitor on while depressing the ALERT RESET key.

2.

The message PARAMETERS RESET TO FACTORY DEFAULTS is displayed.

3.

The monitor enters normal operational mode using the factory default values listed in the Specifications chapter.

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Section 4

Alerts

Overview The Model 2001 monitor provides audible and visible limit alerts for oxygen saturation, and pulse rate. SpO2 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. Broken or damaged sensors, extension cables or monitors can also cause alerts to occur.

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. Alert Limits are 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.

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 can be reset by the user, or the monitor can be set to adjust limit alerts automatically. Alert limit settings are retained 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 alerts can be temporarily silenced for two minutes. Audible alerts can be suppressed completely using the Audio Off feature; also the Audio Off feature itself can be disabled for use in situations where suppressing audible alerts is undesired. Red Alert Bar: • stops flashing automatically if the parameter that caused a limit alert returns within its limits • can instead be set to continue flashing until the ALERT RESET key is pressed • can be turned off altogether

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

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

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Section 4

Auto Alert Limits

If the parameter returns within its limits before 10 seconds elapse: Assuming the 10s LIMIT ALERT DELAY is YES (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 10s LIMIT ALERT DELAY is NO.) • •

•

An audible alarm will sound (Two Minute Silence and Audio Off features silence the audio. Refer to “Audio” 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 ALERT RESET key is pressed. (This allows the user to determine which limit was violated.) If the limits are unlatched, the indicator and violated limit display stop flashing.

Auto Alert Limits The sensor must be applied and the monitor displaying SpO2 and Pulse Rate. To set Auto Alert Limits based on recent patient data:

Press ALRT

Press AUTO

SET ALERT LIMITS appears

The monitor sets new limit values and AUTO ALERT LIMITS SET appears

NOT ENOUGH DATA TO SET AUTO LIMITS is displayed if AUTO is pressed and no SpO2 and Pulse Rate values are displayed. The limits are not changed.

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). 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).

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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 AUTO was selected (maximum = 249 and minimum = 30). For example, if the pulse rate is 72 when AUTO is pushed, the system will set the upper alert limit to 90 (72+25% = 72×1.25 = 90) and the lower alert to 54 (72-25% = 72×0.75 = 54).

Setting Alert Limits Manually To manually adjust the SpO2 and Pulse Rate alert limits

Press ALRT SET ALERT LIMITS appears

Press SEL to move “ to the limit to be changed.

“

Press ↑ ↓ to increase or decrease the selected limit.

Press RUN

WARNINGS Care should be exercised to ensure clinically reasonable alert limit settings are selected. Respironics does not recommend the setting of limit values to such a wide span as to effectively render the alert limit feature useless. After the limit values are properly set, periodically confirm patient status by alternate means and do not rely solely on alerts generated when a limit is violated. The Model 2001 monitor 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. 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.

Limit Alerts-Latched/Unlatched Alerts caused by violation of an alert limit setting are normally “Latched”. If a latched alert is active for 10 seconds, even if the parameter then returns within its limits, the violated alert limit display and the indicator continue to flash until the ALERT RESET key is pressed. Model 2001 also supports “Unlatched” alerts. The flashing of the violated alert limit and the will stop automatically when the parameter returns within its limits.

indicator

To select Latched or Unlatched alerts:

YES provides latched alerts; NO provides unlatched alerts.

Press MENU (3 sec) SPO2 SETUP OPTIONS appears

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Press NEXT until ALERT OPTIONS 1 appears

Press LATCH

Press YES or NO

ALERTS LATCHED appears

ALERTS OPTIONS 1 reappears

ALERTS OPTIONS 1 reappears Press RUN

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Section 4

Alert Limit Settings-Retained/Defaults

NOTE The Latched or Unlatched alert setting remains in effect until changed, even if the monitor is turned off and on.

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 Default start-up values at each power up instead. To use Retained or Default alert limit settings at power up:

YES. The monitor uses the alert limit settings from the previous use. NO. The monitor uses default alert limits: SpO2 100-85, Pulse Rate 150-40

Press MENU (3 sec) SPO2 SETUP OPTIONS appears

Press NEXT until ALERT OPTIONS 1 appears

Press DFLT

Press YES or NO

RETAIN ALERT LIMITS appears

ALERTS OPTIONS 1 reappears

Press RUN to return to the Main Menu

Alerts-Delayed/Instant When SpO2 or the Pulse Rate violates an alert limit, the violated limit display and the indicator flash immediately, but the audible alarm and Alert Bar (if enabled) are delayed for 10 seconds. This delay helps avoid “nuisance” alarms. If the parameter returns within its limits during that 10 seconds, the alert is cancelled. NOTE: Eliminating the delay also “Latches” the alert as soon as it occurs. Refer to “Limit Alerts-Latched/ Unlatched” on page 13. To select or eliminate the delay:

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

Press MENU (3 sec) SPO2 SETUP OPTIONS appears

Press NEXT until ALERT OPTIONS 2 appears

Press DELAY

Press YES or NO

10s LIMIT ALERT DELAY appears

ALERTS OPTIONS 2 reappears

Press RUN to return to the Main Menu

NOTE The Alert Delay setting remains in effect until changed, even if the monitor is turned off and on.

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Alerts

Alert Bar-Latched/Unlatched/Off

Alert Bar-Latched/Unlatched/Off The red Alert Bar to the right of the monitor display can be set to operate in three different modes. •

• •

Latched: 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 parameter returns within its limits, until the ALERT RESET key is pressed.* Unlatched: 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. Off: the Alert Bar will not flash under any condition if it is turned off.

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

YES: Latched. NO: Unlatched.

Press MENU (3 sec) SPO2 SETUP OPTIONS appears

Press NEXT until ALERT OPTIONS 2 appears

Press BAR ALERT BAR LATCHED appears

Press YES, NO or

OFF

Press RUN to return to the Main Menu

ALERTS OPTIONS 2 reappears

NOTE The Alert Bar setting remains in effect until changed, even if the monitor is turned off and on.

Alert Volume To adjust the audible alert volume: NOTE: Alerts are still audible at the lowest setting. Use the Two Minute Silence or Audio features to silence audible alerts. Refer to “Audio” on page 8.

Press MENU

Press AUDIO

Press ALERT

SYSTEM OPTIONS appears

SET AUDIO FEATURES appears

SET ALERT VOLUME appears

Press ↑ ↓ to increase or decrease the alert volume setting (01-07)

Press RUN to return to the Main Menu

*However, if Unlatched Alerts are selected (See “Limit Alerts-Latched/Unlatched” on page 13), the Alert Bar will turn off when the alerting parameter returns within its limits.

Rev. D

2001 User’s Manual

15