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2001
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Novametrix 2001 User Manual

Model 2001
Pulse Oximeter
User’s Manual
May11, 2000
Novametrix Medical Systems Inc.
5 Technology Drive, Wallingford, Connecticut, U.S.A. 06492.
Copyright 2000. All rights reserved. No part of this manual may be reproduced
without the written permission of Novametrix Medical Systems Inc.

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: techline@novametrix.com
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 Release, revision 00 11-May-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
Rev. 00
Model 2001
User’s Manual
i
Section
Declaration of Conformity with European Union Directive
[This page intentionally blank.]
ii
Model 2001
User’s Manual Rev. 00
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 SpO
and Pulse Rate ........................................................................................................ 31
SpO
2
Display Averaging ...............................................................................................31
SpO
2
Sensors ................................................................................ 27
2
Rev. 01 Model 2001 User’s Manual
iii
Pulse Rate Display Averaging ...................................................................................... 31
Pulse “Beep” Volume ................................................................................................... 31
Signal Bar .....................................................................................................................32
Plethysmogram Display ............................................................................................... 32
Operating Mode Selection ............................................................................................ 33
SpO
Timer .................................................................................................................. 33
2
Trend Memory ...................................................................................................................35
Trend Data Compression ............................................................................................. 36
and Dual Trend Displays .................................................................................... 36
SpO
2
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
Model 2001 User’s Manual Rev. 01
iv
Section 1
Introduction
This manual describes the use and operation of the Novametrix Medical Systems Inc.
Model 2001
settings. It provides reliable measurement, display and alerts for functional pulsatile oxygen saturation (SpO 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 SpO 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.
is a lightweight, easy to use, pulse oximeter designed to be used in a variety of clinical
) and pulse rate. The monitor can be powered from the AC Mains (line voltage) or from its
2
and pulse rate are updated every 8 seconds. In addition, trend “events”
2
Model 2001
Pulse Oximeter Monitor from

SpO2 Principles of Operation

Model 2001
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
value displayed by most co-oximeters.
measures oxygen saturation and pulse rate with sensors that contain red and infrared light
is calibrated to display “functional” saturation. This differs from the “fractional” saturation
Equation 1. Functional Saturation Calculation
Rev. 01 Model 2001 User ’s Manual
Functional Saturation =
HbO
= Fractional Hemoglobin
2
COHb = Carboxyhemoglobin METHb = Methemoglobin
100 - (COHb + METHb)
HbO
2
1
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
LIGHT display message indicates a non-SuperBright™ Sensor may be in use.)
must be used in conjunction with SuperBright™ saturation sensors. (An INSUFFICIENT

Indications and Usage

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

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.
Model
Separate collection
Ensure that spent batteries are collected separately when dis-
Pb
Model 2001 User’s Manual Rev. 01
2
posed of. Found on the internal battery. Refer to qualified ser­vice personnel when battery replacement is required.
Section 2
Patient Safety
The SpO2 input for the 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
• Do not operate
• Do not operate
• Connect the line cord only to a grounded hospital-grade outlet.
• Care should be exercised to assure continued peripheral perfusion distal to the SpO
• Components of this product and its associated accessories which may have patient contact are free
• The
Model 2001
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.
after application.
of latex.
Model 2001
A technical Service Manual (Catalog No. 9400-90) is available for use by technical personnel.
Model 2001
and its accessories clean.
Model 2001 Model 2001
contains no user serviceable parts. Refer servicing to qualified service personnel.
Pulse Oximeter is electrically isolated. Patient leakage current
when it is wet due to spills or condensation. if it appears to have been dropped or damaged.
Model 2001
should be connected
sensor site
2

Warnings

WARNING
!
• Explosion Hazard: Do NOT use
• Electrical Shock Hazard: Always turn
• Do not operate
• Do not operate
• Patient Safety: Extreme care should be exercised with neonates to assure continued circulation
• Failure of Operation: If the monitor fails to respond as described, do not use it until the situation
• Patient Safety: Care should be exercised to assure continued peripheral perfusion distal to the
• Data Validity: As with all pulse oximeters, inaccurate SpO
Rev. 01 Model 2001 User ’s Manual
Indicates a potentially harmful condition that can lead to personal injury
Model 2001
this instrument in such an environment may present an explosion hazard.
Do NOT use a damaged sensor or one with exposed electrical contacts. Refer servicing to qualified service personnel.
Model 2001 Model 2001
distal to the sensor site after application.
has been corrected by qualified personnel.
SpO
sensor site after application.
2
when it is wet due to spills or condensation. if it appears to have been dropped or damaged.
in the presence of flammable anesthetics. Use of
Model 2001
off and remove line cord before cleaning it.
and Pulse Rate values may be caused by:
2
3
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 SpO
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.
sensor distal to a blood pressure cuff. Valid data
2
CANNOT
be processed

Cautions

CAUTION
Indicates a condition that may lead to equipment damage or malfunction.
• Do not operate
• Do not operate
• 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
• 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.
Model 2001 Model 2001
when it is wet due to spills or condensation. if it appears to have been dropped or damaged.
force the sensor onto large objects such as the bed rail.
NOT
Model 2001 User’s Manual Rev. 01
4
Section 3
1 17
911
13
8765432
14
1516
1210

Front Panel

Illustrations
1.
2. Low Battery Indicator. Illuminates (red)
3. AC Power Indicator. Illuminates
4. Two Minute Silence Indicator.
5.
6. Audio Off Indicator. Flashes (yellow)
7.
8. Alert Indicator. Flashes (red) when an
POWER
if monitor powered from battery. Flashes to warn of low battery voltage condition.
(green) if monitor is connected to AC (Mains) and the rear panel power switch is set to “|”.
Illuminates (yellow) when the key is pressed. Alarms silenced for two minutes.
AUDIO
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.
as a warning that the audible alarms are disabled.
ALERT RESET
active alert indicators. Alerts will reactivate if alert condition still exists.
alert/alarm occurs. Continues to flash until condition corrected and is pressed.
key. Press to turn on monitor.
AUDIO
key. Press and release to turn
key. Press to disable
ALERT RESET
9.
10. Kickstand and bedrail hanger.
11.
12. Red Alert Bar. Flashes (red) when an alert/
13. SpO
14. Contrast key. Press to adjust display for
15. Waveform or trend data displayed here.
16. Menu Display. Softkey functions and menu
17. Parameter Numerical Displays. Numerical
SOFTKEYS
(left to right) to initiate action listed above each key.
EVENT
marker” into the trend.
alarm occurs. Continues to flash until condition corrected and is pressed.
Sensor Input Connector.
2
optimum viewing.
messages displayed here.
displays and alert limit settings for measured parameters displayed here. Also display units and special display options noted here.
. Press software keys 1-5
key. Press to place an “event
ALERT RESET
Rev. 01 Model 2001 User ’s Manual
5
Section 3 Rear and Top Panel

Rear and Top Panel

123456 7
10
8
9
1. Ground symbol: Equipotentiality. Connection to monitor’s chassis.
2. 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.
3. Line Cord Connector: The AC (Mains) line cord attaches to the monitor here.
4. 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.
5. Fuse Compartment: The AC (Mains) line fuse(s) are inside this compartment. Pry open with small screwdriver.
6. AC Mains Voltage: The currently selected AC Mains input voltage is identified here.
11
12
7. 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 Type BF equipment.
Model 2001
is
Model 2001 User’s Manual Rev. 01
6
Section 4

AC Mains (Line Cord) and Battery Power

AC Operation

Monitor Basics
The
Model 2001
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.
Pulse Oximeter can operate from AC Mains (line cord) power or from its internal

Battery Operation

Model 2001
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, fully charged battery, a half charge, and indicates less than 30 minutes of battery life remain. Note 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.
can operate for up to three hours while powered from its internal battery (excessive alerting
Model 2001
: The battery icon appears fully charged for the first minute after switching to battery power; after
displays a battery icon to the left of the Signal Bar. indicates a

Power Key

• If the AC ON icon is illuminated, the internal battery is being charged, and the monitor uses line power if turned on.
Rev. 01 Model 2001 User ’s Manual
Model 2001
is connected to AC Mains (line cord) power,
7
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.
•
Model 2001
minutes of battery power remain. If AC ON is not illuminated, the monitor will operate from battery power.
can operate for up to 3 hours on battery power. LOW BAT illuminates when 15
1. To turn the monitor on or off, press
POWER
.
Ensure the monitor operates as stated below before applying a sensor to the patient.
• All displays and indicators illuminate briefly
1
• 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 menu choice. Press
YES
to erase the stored trend data.

Audio Key

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

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.
Model 2001 User’s Manual Rev. 01
8

EVENT Key

Monitor Basics
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, pressing monitor again receives valid signals from the sensor.
ALERT RESET
ALERT RESET
key to stop an alert condition that is not currently active. Any alert
will reset (silence) the audible alarms until monitoring is resumed and the
EVENT Key
Press the
EVENT
WAVEFORM FROZEN appears on the display. To return to the real time display before the sixty second time out, press 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.
When the message PRINT WAVEFORM? will be displayed for 60 seconds. Pressing the time will cause a printout of the waveform; this printout will be the 5 seconds proceeding the freezing of the display.
When the
EVENT STORE
menu. The
EVENT
key while in the Main Menu will freeze the waveform for sixty seconds; the message
Model 2001
Model 2001
key is pressed, the message STORE WAVEFORM? will be displayed for 60 seconds. Pressing
will store the waveform to the NovaCARD. Pressing ID will bring up the patient identification
ERASE
key to place an “event” marker into the monitor’s trend memory. Pressing the
RUN
softkey. Pressing the
is configured for operation with a printer and the
is configured for operation with the NovaCARD memory module and the
softkey will erase the card. Pressing
EVENT
RUN
softkey in menus other than the Main Menu
EVENT
will return to real time display.
key is pressed, the
PRNT
key during this

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
RUN
Press
NOTE:
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).
to return to the Main Menu.
RUN
always displays the Main Menu.
MENU
key. Press

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.
MENU
and new menu and softkey functions are displayed.
NEXT
and
PREV
(previous) move through the
Rev. 01 Model 2001 User ’s Manual
9
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: SpO
100-85, Pulse 150-40
2
• Alert Limits: Retained on start-up
• Alert Volume: Maximum (07)
• Allow Audio Off: Yes
• Averaging: SpO
- 8 seconds, Pulse Rate - 8 seconds (fixed)
2
• 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;
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.
Model 2001 User’s Manual Rev. 01
10
ALERT RESET
key.
Section 5

Overview

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

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 for SpO Rate displays.
Model 2001
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.
and Pulse Rate. Alert Limits are the smaller numbers displayed to the left of the SpO2 and Pulse
2
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 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.
—the maximum and minimum allowable values
ALERT
and
2

Limit Alerts

If SpO2 or Pulse Rate violates an alert limit setting:
Rev. 01 Model 2001 User’s Manual
11
Section 5 Auto Alert Limits
• The violated alert limit display 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 presses the
ALERT RESET
key. (This allows the user to determine which limit was violated.)
• If the limits are unlatched, the indicator and violated limit display stop flashing.
ALERT RESET
key starts to flash.

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 SpO
NOT ENOUGH DATA TO SET AUTO LIMITS is displayed if and Pulse Rate data is acquired. The limits in this case are not changed.
2. Press the
3. Press the
ALRT
softkey and SET ALERT LIMITS appears.
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 (maximum setting =100). The low auto alert limit is set to 5 less than the SpO
AUTO
was pressed. (minimum setting = 50).
and Pulse Rate.
2
AUTO
is pressed before sufficient SpO
AUTO
was pressed
value displayed when
2
2
Model 2001 User’s Manual Rev. 01
12

Setting Alert Limits Manually

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

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
For example, if the pulse rate=72 when (72+25%=72u1.25=90) and the lower alert to 54 (72-25%= 72u0.75=54).
AUTO
was selected (maximum = 249 and minimum = 30).
AUTO
is pushed, the system will set the upper alert limit to 90
Setting Alert Limits Manually
The user can manually adjust the SpO2 and Pulse Rate alert limits.
WARNING:
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:
• SpO
• 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:
Care should be exercised to ensure clinically reasonable alert limit settings are
- High 100-55, Low 95-50
2
1. Press the
2. Press
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:
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
ALRT
softkey and SET ALERT LIMITS appears.
SEL
(select) to move ““ to the limit to be changed.
Model 2001
will not allow a parameter’s high and low alert limits to be set to within
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
Rev. 01 Model 2001 User’s Manual
13
Section 5 Alert Limit Settings—Retained/Defaults
and the indicator continue to flash until the user presses the
ALERT RESET
key. This indicates
which parameter caused the alert.
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 does not have to press the
ALERT RESET
when unlatched alerts are in use.
To select Latched or Unlatched alerts:
1. Press and hold the
2. Repeatedly press the
3. Press
LATCH
MENU
softkey for 3 seconds. SPO2 SETUP OPTIONS is displayed.
NEXT
softkey until ALERT OPTIONS 1 appears.
and ALERTS LATCHED appears.
The current setting flashes.
YES
4. Press
YES NO
NOTE:
or NO as desired.
provides latched alerts that require the user to press
ALERT RESET
to clear them
provides unlatched alerts that reset automatically without user intervention.
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.
RUN
5. ALERT OPTIONS 1 reappears. Press
to return to the Main Menu.

Alert Limit Settings—Retained/Defaults

When
Model 2001
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
2. Repeatedly press the
3. Press
DFLT
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
is powered on, it restores the (Retained) alert limit settings that were in effect when
MENU
softkey for 3 seconds. SPO2 SETUP OPTIONS is displayed.
NEXT
softkey until ALERT OPTIONS 1 appears.
(default) and RETAIN ALERT LIMITS appears.
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
Model 2001 User’s Manual Rev. 01
14

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:
Alerts
1. Press and hold the
2. Repeatedly press the
3. Press
DELAY
MENU
softkey for 3 seconds. SPO2 SETUP OPTIONS is displayed.
NEXT
softkey until ALERT OPTIONS 2 appears.
and 10s LIMIT ALERT DELAY (violation) appears.
The current setting flashes.
YES
4. Press
YES NO
NOTE:
or NO as desired.
. Audible and Alert Bar alerts for violated alert limits are delayed 10 seconds.
. Audible and Alert Bar alerts occur as soon as an alert limit is violated.
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.
RUN
5. ALERT OPTIONS 2 reappears. Press
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 parameter returns within its limits, until the user presses the
ALERT RESET
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”.
key.
*
NOTE:
The red (bell shaped) indicator to the left of the
ALERT RESET
key will always
flash whenever a limit alert occurs. Unlike the Alert Bar, the cannot be turned off.
To turn the Alert Bar on (latched or unlatched) or off:
MENU
1. Press and hold the
2. Repeatedly press the
3. Press
BAR
and ALERT BAR LATCHED appears.
softkey for 3 seconds. SPO2 SETUP OPTIONS is displayed.
NEXT
softkey until ALERT OPTIONS 2 appears.
The current setting flashes.
4. Press
Rev. 01 Model 2001 User’s Manual
YES
or NO or
*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.
OFF
as desired.
15
Section 5 Alert Volume
YES
. Alert Bar starts to flash as soon as a limit alert occurs.
NO
. Alert Bar starts flashing 10 seconds after an alert limit violation occurs.
OFF
. Alert Bar will not flash under any condition.
NOTE:
Once the Alert Bar 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 Volume

The volume of the monitor’s audible alert is user adjustable. The alert volume feature cannot be used to eliminate audible alerts because the alert is still audible at its lowest setting. Use the temporarily or permanently silence alerts. Refer to “Audio Key” on page 8.
To vary the audible alert volume;
MENU
1. Press the
2. Press the
3. Press the
softkey and the SYSTEM OPTIONS appears.
AUDIO
softkey and SET AUDIO FEATURES appears.
ALERT
softkey and SET ALERT VOLUME appears.
An audible tone sounds and the current alert volume setting (01-07) is displayed between the up and down arrows.
4. Press n or p to increase or decrease the alert volume setting.
5. Press
RUN
to return to the Main Menu.
AUDIO
key to

Audio Mute

In situations where preventing the occurrence of audible alarms by use of the Audio Off feature is not desired, the monitor can be set to disallow use of Audio Off.
Once the monitor is set to disallow use of Audio Off, AUDIO OFF DISABLED is briefly displayed in the Message Center each time the user tries to enable Audio Off.
NOTE:
audible alarms for two minutes and then reactivates them, is a separate feature and is not affected by the status of Audio Mute feature.
To enable or disable the monitor’s ability to permanently silence the audible alarms:
1. Press and hold the
2. Repeatedly press the
3. Press
The current setting flashes.
4. Press
Unlike Audio Off, the Two Minute Silence feature, which temporarily silences the
MENU
softkey for 3 seconds. SPO2 SETUP OPTIONS is displayed.
NEXT
softkey until ALERT OPTIONS 1 appears.
MUTE
and ALLOW AUDIO OFF appears.
YES
or NO as desired.
Model 2001 User’s Manual Rev. 01
16

Faults, Alerts and Errors

YES NO
Alerts
. The user can use Audio Off to permanently silence audible alerts.
. The user cannot use Audio Off. AUDIO OFF DISABLED is displayed instead.
NOTE:
remains in effect, even if the monitor is turned off and on, until changed by the user.
5. ALERT OPTIONS 1 reappears. Press
Once the decision to allow or disallow the user to use Audio Off is made, that choice
RUN
to return to the Main Menu.
Faults, Alerts and Errors
Listed below are the fault, alert and error conditions displayed by

Alert Limit Messages

PULSE-HIGH PULSE-LOW PULSE OUT OF RANGE SpO2-HIGH SpO2-LOW
Selected pulse rate high alert limit has been violated.
Selected pulse rate low alert limit has been violated.
Pulse rate is less than 30 bpm or is greater than 250 bpm.
Selected saturation high alert limit has been violated.
Selected saturation low alert limit has been violated.

Fault and Error Condition Messages

Model 2001
.
SENSOR OFF PATIENT
BAD SIGNAL TIMEOUT
CONNECT SpO2 SENSOR
ERROR - FAULTY SEN­SOR
INSUFFICIENT LIGHT
LIGHT INTERFERENCE
Sensor disconnected from patient, improperly applied, or placed on an area too translucent for proper sensor operation. Reposition sensor.
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. Changes to PULSE SEARCH after 30 seconds.
1. Sensor is disconnected from the monitor.
2. Sensor is faulty. Remove sensor from use and contact qualified service personnel.
3. Sensor is placed on a site too thick. Reposition the sensor on a thinner (less opaque) section of tissue.
Sensor faulty. Remove sensor from use and contact qualified service personnel.
Sensor placed on a site too thick (or opaque) for adequate light transmission. Changes to REPOSITION SENSOR after 30 seconds.
1. A non-SuperBright™ sensor is connected, use only 87xx series sensors.
2. Sensor is faulty. Remove sensor from use and contact qualified service personnel.
Ambient light sources (sunlight, warming lights, etc.) are interfering with sensor light sources. Shield the sensor from ambient light sources. Changes to REPOSITION SENSOR after 30 seconds.
Rev. 01 Model 2001 User’s Manual
17
Section 5 Faults, Alerts and Errors
LOW SIGNAL STRENGTH
MONITOR ERROR *

Miscellaneous Messages

AUDIO OFF DISABLED
BATTERY VERY LOW PLUG IN AC POWER
EVENT MARKED MONITOR PERFORMING
SELF TEST. Parameters Reset
To Factory Default
DSP SERIAL TIMEOUT
or
DSP NOT RESPONDING
DSP ERROR
Pulse strength as detected by sensor is too weak for proper monitor operation. Reposition sensor. Changes to REPOSITION SENSOR after 30 seconds.
Monitor faulty, where * is a message or error code. Record error message (appearing on bottom line of display) and contact qualified service personnel.
Displayed if user tries to enable Audio Off mode (by pressing and holding the AUDIO key) while the “Allow Audio Off” portion of the Options Menu is set to “No”.
1. Monitor is running on battery power and the battery power has been depleted. Connect line cord to AC Mains power source and set the rear panel switch to “|”
2. Monitor’s rear panel fuse has blown, monitor switched over to battery power and has depleted battery life. Contact qualified service personnel.
An event was successfully entered into trend memory.
Monitor is performing its power up system diagnostic tests.
Displayed when monitor is turned on while pressing the
ALERT RESET
power on. Monitor now using factory default settings.
The main microprocessor has lost communication with the Digital Signal Processor. This message will be displayed for 10 seconds then the monitor will reset. The error should be recorded and reported to service if the message is persistant.
System error has been detected on the Main Board. This message will be displayed for 10 seconds then the monitor will reset. The error should be recorded and reported to service if the message is persistant.
key, or if an error found in battery-backed RAM during
Model 2001 User’s Manual Rev. 01
18
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