3900 and 3900P TruTrak+ Users Manual March 2005

GE Healthcare

3900/3900P Pulse Oximeter TruTrak®+

User’s Manual

♥

6050-0006-406 March 2005

Important Rx Only (USA) Attention! Consult the accompanying instructions before using this device. The safety, reliability, and performance of this device can be assured only under the following conditions: •

If it is used according to the accompanying operating instructions.

•

If fittings, extensions, readjustments, changes, or repairs are carried out by agents authorized by Datex-Ohmeda.

•

If it is used in buildings having ground equalization wiring that complies with relevant local standards and regulations.

This device must be cleaned and checked periodically. Do not use a defective device. Parts that are broken, missing, plainly worn, distorted, or contaminated should be replaced immediately. If repair or replacement becomes necessary, request service advice from Datex-Ohmeda. Do not repair this device or any of its parts other than in accordance with written instructions provided by DatexOhmeda. The user of this device shall have the sole responsibility for any malfunction that results from improper use, faulty maintenance, improper repair, unauthorized service, damage, or alteration by anyone other than Datex-Ohmeda.

Trademarks Datex®, Ohmeda®, OxyTip®, PerfTrak®, TeleOximetry®, TruTrak®, and PIr ® are the property of GE Healthcare Finland Oy. All other product and company names are the property of their respective owners.

0537

GE Healthcare Finland Oy Helsinki, Finland +358 10 394 11 www.gehealthcare.com © 2005 General Electric Company. All rights reserved.

Table of Contents 1/Overview Product description...1-1 Intended use...1-1 TruTrak+ technology...1-1 PIr pulsatile value...1-2 Other features...1-2 Functional components...1-3 Principles of operation...1-4 Calibration ...1-5 Front panel...1-6 Alarm silence button...1-7 Alarm silence ...1-7 All mute...1-7 Numeric display ...1-7 Graphic display...1-8 SpO2 alarm limits, high and low ...1-9 Pulse rate alarm limits, high and low ...1-9 Display contrast adjuster...1-9 Power/Standby button/AC power light ...1-9 Battery operation...1-9 Carrying handle ...1-10 Sensor connector ...1-10 Screen option buttons...1-10 Pulse beep volume button...1-11 Alarm volume button...1-11 Printer ...1-11 Rear panel...1-12 Power entry module...1-12 Equipotential ground connector...1-12 Product information label ...1-12 Mode Switch ...1-12 RS-232 serial/analog connector ...1-12 Precautions...1-13 Warnings ...1-13 Failure of operation...1-13 Data validity...1-13 Explosion hazard...1-13 Electrical shock hazard...1-13 Electrical shock and flammability hazard...1-14 Patient safety...1-14 Patient safety (sensors)...1-14 Patient safety (modem) ...1-14 RS-232 system interconnection ...1-15 Cautions...1-15 Handle the monitor with care...1-15 Cleaning ...1-15 Sensors...1-15 Battery...1-15 Printer...1-15 Disposal...1-15

i

Table of Contents 2/Setup and Operations Powering the oximeter...2-1 Setup...2-2 Factory settings ...2-2 Before powering on the oximeter...2-2 After powering on the oximeter ...2-2 Mode switch settings ...2-3 Language selection...2-3 Averaging mode...2-4 PIr pulsatile value display ...2-4 EMI line frequency...2-4 Checkout procedure...2-5 Signal and data validity...2-8 Plethysmographic waveform...2-8 Low perfusion...2-8 Signal noise ...2-9 Numeric display ...2-10 SpO2...2-10 Pulse rate ...2-10 PIr pulsatile value...2-10 Waveform screen button...2-11 Menu button...2-11 Main menu function key buttons...2-11 LABELS...2-12 Summary: custom patient labels...2-12 Select field function keys...2-13 – / + Select character function keys...2-13 Function key...2-13 CLEAR...2-14 Locking label lines...2-14 SETTINGS...2-15 SAVE LIMITS...2-15 ALL MUTE...2-16 BAUD RATE...2-16 ANALOG...2-16 MODE...2-16 OUTPUT...2-16 CONTRAST (3900P printer only) ...2-16 Date and time...2-17 Date...2-17 Time...2-17 Trend options ...2-18 Trend function keys ...2-19 Scroll buttons...2-19 Shift buttons ...2-19 CLEAR...2-19 Viewing time scale for display...2-20 Trend data ...2-20 Patient function key lockout...2-22 ii

Table of Contents 3/Messages and Troubleshooting Messages...3-1 Alarm categories...3-5 High priority...3-5 Medium priority...3-5 Low priority ...3-6 System failure...3-6 Troubleshooting ...3-7

4/Printer Printer buttons...4-2 Print real-time data...4-2 Summary statistics only...4-2 Trend print...4-2 Stop print/advance paper...4-3 Printed data samples...4-3 Printer maintenance...4-5 Replacing the paper roll...4-5 Removing a paper jam...4-6

5/TeleOximetry Using a modem: summary ...5-1 Modem connection...5-2 Modem status ...5-3 Select data...5-4 Send...5-5 FAX ...5-6 Fax transmission messages ...5-7 Canceling a transmission (FAX CANCELED)...5-7 Sending data to a remote computer ...5-8 Remote computer requirements...5-8 Preparing for transmission ...5-8 Dialing and answering calls at the remote computer ...5-8 Receiving the data file at the remote computer...5-8 Remote computer...5-9 Wait for call...5-9 Canceling a transmission (TRANSMISSION CANCELED) ...5-10 Transmission failure messages ...5-10 Modem setup...5-11 Guard tone...5-11 Custom initialization string...5-11 Default initialization string...5-12 Sample reports ...5-13 Remote computer report format...5-13 InstaReport fax-SpO2 mode...5-14 InstaReport fax-PIr mode ...5-16 iii

Table of Contents 6/Maintenance and Service Cleaning ...6-1 Oximeter (with or without the printer) ...6-1 Recharging the battery...6-2 Replacing the battery ...6-2 Replacing the fuses ...6-3 Repair policy and procedure...6-4 Packaging and return procedure ...6-4 Parts list...6-5

7/Compliance and Specifications Compliance with standards...7-1 General safety requirements...7-1 Electromagnetic compatibility (EMC) ...7-2 Electromagnetic effects...7-2 Safety checks for software ...7-2 Specifications...7-3 Circuitry...7-3 Audio indicators...7-3 Audible alarms ...7-3 Alarm limits ...7-3 Displays...7-4 Mode switch ...7-4 SpO2...7-4 Interfering substances...7-4 Pulse rate...7-5 PIr pulsatile value ...7-5 Sensor emitter wavelength ranges ...7-5 Environmental...7-5 Electrical...7-5 Battery...7-5 Power ...7-6 Current leakage...7-6 Fuses...7-6 RS-232 serial/analog connector ...7-6 Serial output...7-6 Analog output...7-6 Dimensions and weight...7-6

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Table of Contents A/Screen Maps Screen maps ...A-1

B/Communications Serial device communications...B-1 Requirements ...B-1 RS-232 interface cable-serial pinout ...B-2 Connection ...B-2 Serial communication output ...B-3 Auto-output mode...B-4 Trend-output mode...B-4 Analog device communications ...B-4 RS-232 serial/analog interface cable-analog pinout ...B-5

Index Warranty

v

List of Figures Name

Page

Figure 1-1. Signal processing block diagram...1-3 Figure 1-2. Comparative light absorption...1-4 Figure 1-3. Extinction versus wavelength graph ...1-4 Figure 1-4. 3900P Pulse Oximeter front panel...1-6 Figure 1-5. 3900/3900P Pulse Oximeter rear panel ...1-12 Figure 2-1. Typical adult plethysmographic waveform ...2-8 Figure 2-2. Typical neonate plethysmographic waveform ...2-8 Figure 2-3. Low perfusion waveform ...2-9 Figure 2-4. Noisy plethysmographic waveform ...2-9 Figure 2-5. Main menu...2-11 Figure 2-6. LABELS screen ...2-13 Figure 2-7. Settings screen options...2-15 Figure 2-8. DATE/TIME screen...2-17 Figure 2-9. Trend screens...2-18 Figure 4-1. 3900P printer...4-2 Figure 4-2. SELECT HOURS screen ...4-2 Figure 4-3. Printed data samples...4-4 Figure 4-4. Replacing the paper roll ...4-5 Figure 4-5. Removing the paper-feed cover ...4-6 Figure 5-1. MODEM STATUS screen ...5-3 Figure 5-2. SELECT HOURS screen ...5-4 Figure 5-3. SEND screen ...5-5 Figure 5-4. PHONE NUMBER screen...5-6 Figure 5-5. SENDING FAX screen...5-7 Figure 5-6. SENDING DATA screen...5-9 Figure 5-7. MODEM SETUP screen...5-11 Figure 5-8. INITIALIZATION STRING screen...5-12

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1/Overview This chapter •

Introduces the product, including the principles of its operation.

•

Describes the oximeter’s controls and features.

•

Lists the precautions you must take when using the oximeter.

Product description The Datex-Ohmeda Model 3900 and Model 3900P pulse oximeters with TruTrak®+ technology feature two easy-to-read displays that present patient data and status information. •

The numeric display shows the SpO2 and pulse rate values.

•

The graphic display shows the plethysmographic waveform (or trend data), messages, the Relative Perfusion Index (PIr ®) pulsatile value, and the high and low alarm limit settings for SpO2 and pulse rate.

You can send current or trend data (SpO2 or PIr pulsatile value) to the built-in printer (3900P only) and to a computer. You can connect a modem to the monitor and use the TeleOximetry® feature to transmit data to a fax machine or computer. You can also set the date and time and create labels for individual data records.

Intended use The 3900/3900P pulse oximeter with TruTrak+ technology is indicated for spotchecking and continuous monitoring of functional oxygen saturation and pulse rate, including monitoring during conditions of clinical patient motion.1 This device is intended for use with adult, pediatric, and neonatal patients in both hospital and non-hospital environments. Important: Only OxyTip®+ sensors can be used with this monitor.

TruTrak + technology TruTrak+ technology improves pulse oximetry performance during conditions of clinical patient motion. In the clinical environment, oximetry readings are affected by several types of patient motion. The types of motion include clenching, pressing, and rubbing as well as extending, flexing, and kicking. Unlike motion technologies that use only a single method to correct for motion, TruTrak+ selects 1

Anesthesia & Analgesia. 2002;94,1S, S54-S60

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3900/3900P User’s Manual

one of many proprietary motion-correction algorithms, depending on the type and intensity of the motion. TruTrak+ technology employs a patented five-step process that consists of 1) high-speed data sampling; 2) motion identification, quantification, and correction; 3) calculation of the SpO2 value; 4) weighting and averaging of the SpO2 value; and 5) the display of an improved SpO2 value. The result of this process is a more accurate and stable displayed SpO2 value, with fewer false alarms or dashed displays. Important: For TruTrak+ performance, the averaging mode must be set to Long. See Setup in chapter 2.

PIr pulsatile value The PIr pulsatile value indicates the strength of the pulse signal at the sensor site: the higher the PIr value, the stronger the pulse signal. A strong pulse signal increases the validity of SpO2 and pulse rate data. PIr is a relative value that varies from patient to patient. Clinicians can use the PIr value to compare the strength of the pulse signal at different sites on a patient in order to locate the best site for the sensor (the site with the strongest pulse signal). You can choose to display or not display the PIr value (see Setup in chapter 2).

Other features

1-2

•

PerfTrak® waveform display, an automatic scale of the plethysmographic waveform to provide a relative indication of the sensor site perfusion level.

•

Large SpO2 digital display for clear differentiation from the pulse rate value.

•

Backlit display and contrast control for excellent visibility in subdued lighting conditions; adjustable viewing angle, using the pull-down feet under the monitor.

•

Direct access to user-selectable high and low alarm limits for SpO2 and pulse rate.

•

An audible pulse indicator with an adjustable volume; the automatic pitch modulation reflects changing SpO2 level.

•

Visual and audible (adjustable volume) alarms.

•

Ability to save volume and alarm limit settings.

•

An alarm-silence feature that silences audible alarms for 120 seconds.

•

An all-mute feature that silences audible alarms until deactivated. This ability to mute all alarms can be disabled.

•

Automatic tiered alarm messages.

•

Language options that display the monitor’s screen text and, in most cases, printed or transmitted data in the selected language.

•

Short, medium, or long SpO2 response averaging modes.

•

Automatic storage of alarm conditions and up to 24 hours of SpO2, pulse rate, and PIr pulsatile value data.

1/Overview

•

Ability to print or transmit the data in trend memory, along with custom patient labels, alarm limit violations, and time stamps.

•

Viewable SpO2 or PIr pulsatile value trend data.

•

Custom patient labels that appear on printer, fax, modem, and serial communication output.

•

Two analog output channels, SpO2 and pulse rate, for connecting a chart recorder or polysomnography machine.

•

An automatic self-test and calibration check at start-up. After start up, the oximeter continuously performs background self-tests.

•

Rechargeable, sealed, lead-acid battery operation, including battery status reporting.

•

A lock button function that prevents unintended changes to settings while monitoring a patient.

Functional components The 3900/3900P oximeter uses the following key electrical component elements to determine SpO2, pulse rate, and PIr pulsatile values: •

The sensor

•

Sensor-signal processing

•

Microprocessor calculations

The sensor consists of •

The light source-red and infrared light-emitting diodes (LEDs)

•

The photodetector-an electronic device that produces an electrical current proportional to incident light intensity

Timing Control

Sensor

Analog Processing

A/D Converter

Digital Processing

Input/ Output

Figure 1-1. Signal processing block diagram The two light wavelengths generated by the LEDs pass through the tissue at the sensor site. The photodetector collects this light (partially absorbed and modulated) and converts it into an electronic signal that is sent to the oximeter for further processing. The electronic circuitry receives the photodetector’s electronic signal, processes it, and passes it on to the microprocessor for calculation of the SpO2, pulse rate, and the PIr pulsatile value.

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3900/3900P User’s Manual

Principles of operation The 3900/3900P pulse oximeter uses a two-wavelength pulsatile system-red and infrared light-to distinguish between oxygenated (O2Hb) and reduced (HHb) hemoglobin, each of which absorbs different amounts of light emitted from the oximeter sensor. The system then calculates the relative percentage of these two constituents and displays SpO2. Variable absorption (due to arterial pulse) Arterial blood absorption Venous blood absorption Absorption Other tissue absorption

Time Figure 1-2. Comparative light absorption Arterial blood pulsation at the test site modulates transmission of the oximeter sensor’s light. Since other fluids and tissues present generally don’t pulsate, they don’t modulate the light passing through that location. The attenuation of light energy due to arterial blood flow is detected and isolated by using the pulsatile portion of the incoming signal. PIr pulsatile value is a measure of the relative size of this portion of the signal. (Red) 660 nm

(Infrared) 940 nm

Extinction (10x)

Wavelength (nm) Figure 1-3. Extinction versus wavelength graph The sensor’s photodetector converts the light, which is partially absorbed and modulated as it passes through the tissue sample, into an electronic signal. Since O2Hb and HHb allow different amounts of light to reach the photodetector at the selected wavelengths, the electronic signal varies according to the light source that 1-4

1/Overview

is “on” and the oxygenation of the arterial hemoglobin. Analog and digital signal processing then converts the light-intensity information into SpO2, pulse rate, and PIr pulsatile values for display on the monitor.

Calibration A CO-oximeter typically uses four or more wavelengths of light and calculates reduced hemoglobin (HHb), oxyhemoglobin (O2Hb), carboxyhemoglobin (COHb), and methemoglobin (MetHb). Datex-Ohmeda pulse oximeters use two wavelengths ranges, 650 nm - 670 nm and 930 nm - 950 nm, both with an average power of less than 1 mW. These wavelengths are used to calculate the presence of O2Hb and reduced HHb. Because of this, pulse oximetry readings will be different than CO-oximetry readings in situations where a patient’s COHb or MetHb are increased. Two different methods of calibration are currently used by manufacturers of pulse oximeters: fractional and functional. Important: This pulse oximeter uses the functional calibration method. The user cannot change the calibration method to fractional. •

Fractional saturation is represented mathematically as the percentage of the total amount of hemoglobin carrying oxygen. It is determined by dividing the oxyhemoglobin by the total hemoglobin. O2Hb

Fractional SpO2 = •

( HbTOTAL )

O2Hb

x 100 =

( O2Hb + HHb + COHb + MetHb ) x 100

Functional saturation is represented mathematically as the percentage of hemoglobin capable of carrying oxygen that is carrying oxygen. O2Hb

O2Hb

Functional SpO2 =

( HbTOTAL – COHb – MetHb )

x 100 =

( O2Hb + HHb ) x 100

The calculation of SpO2 assumes 1.6% carboxyhemoglobin (COHb), 0.4% methemoglobin (MetHb), and no other pigments. Appreciable variation from these values will influence SpO2 accuracy. These values are based on the Ohmeda Pulse Oximeter Empirical Calibration Study.

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3900/3900P User’s Manual

Front panel NOTE: The 3900 model does not have the built-in printer (item 13).

♥

Figure 1-4. 3900P Pulse Oximeter front panel

1-6

1

Alarm silence button

2

Numeric display (LED)

3

Graphic display (LCD)

4

SpO2 alarm limits, high/low setting buttons

5

Pulse rate alarm limits, high/low setting buttons

6

Display contrast adjust slide

7

Power/Standby button

8

Carrying handle

9

Sensor connector

10

Screen display option buttons

11

Pulse beep volume button

12

Alarm volume button

13

Built-in printer (3900P)

1/Overview

1

Alarm silence button This button has two functions: • 120-second alarm silence-activated by a single press. • Continuous all mute-activated by three quick presses (if the all-mute feature is enabled). Press once to deactivate.

Alarm silence When an active alarm condition exists, press this button to silence the audible portion of the alarm for 120 seconds. The flashing red or yellow alarm light becomes a steady light. If an alarm condition still exists after 120 seconds, the audible tone and flashing light resume. Exceptions: Both NO SENSOR and SENSOR OFF audible alarms will not be activated until after the unit obtains a valid signal. The same conditions apply to an active audible alarm for NO SENSOR, SENSOR OFF, or SENSOR FAILURE that has been silenced; i.e., once the sensor alarm condition is acknowledged by silencing the audible alarm, a new audible alarm will not sound until the condition has been cleared and the unit obtains a valid signal. NOTE: Pressing the alarm silence button produces 120 seconds of silence, regardless of other alarm conditions that may occur during this 120-second interval, except for the SYSTEM FAILURE, CONNECT UNIT TO LINE POWER, and BUTTON STUCK alarms.

All mute To continuously silence any alarm that can be silenced, press the alarm silence button three times within three seconds. After you have activated all mute, the all mute icon flashes between the SpO2 and pulse rate alarm limit settings on the right side of the screen display. (On Japanese menu screens, the icon flashes at the upper right beside the first menu option.) When an alarm condition occurs, the alarm button light flashes and the alarm message appears on the waveform display but no audible alarm sounds. When all mute is active, press the alarm silence button once to deactivate this feature and enable all audible alarms. The ability to mute all alarms continuously can be disabled; see SETTINGS, ALL MUTE in chapter 2.

2 Numeric display SpO2 numeric area-calculated SpO2 Pulse rate numeric area-calculated pulse rate

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3900/3900P User’s Manual

3 Graphic display 1

2

85 3

PIr 4 1

1.25

130 40

Plethysmographic waveform (also the display area for trend data, screen menus, and options) The PerfTrak waveform display appears after the monitor has detected data from the sensor. It represents the blood volume change of the hemodynamic system, assuming no other factors (e.g., motion artifact) are present. This waveform scales automatically to the perfusion level or strength of the signal being received at the patient monitoring site. See Trend options in chapter 2 for detailed descriptions of the SpO2 and PIr pulsatile value trend screens.

2

Message area. Status and alarm messages appear above the waveform area on the waveform display (the height of the waveform is reduced while messages are displayed). Status messages give you information about the oximeter's operating condition. Alarm messages alert you to conditions that need your attention. See chapter 3 for complete alarm and status message information.

3

SpO2 and pulse rate alarm limits The high and low alarm limit settings appear here. If a limit is set to OFF, three dashes appear in the location for that limit. When an SpO2 or pulse rate limit is violated, the LED on the numeric display and the LCD’s limit value flashes for that alarm.

4

PIr pulsatile value Dashes (- - -) appear if the following conditions exist: no sensor is connected to the unit, the sensor is not attached to the patient, the sensor has failed, there is insufficient light penetrating the tissue site, or there is too much ambient light.

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1/Overview

SpO 2

–

+

4 SpO2 alarm limits, high and low While viewing the waveform screen, the top button sets the high alarm limit and the bottom button sets the low alarm limit. For either limit, press the + side of the button to raise the value or the – side to lower it. As you press one of these buttons, the values do not cycle through the available settings; e.g., when you reach 100, the value does not cycle (or wrap) to 50 or OFF and vice versa. When you are using menu options, these two buttons become function keys-the function each performs depends on the options available in the menu on the screen; see Menu button in chapter 2.

♥ –

5 Pulse rate alarm limits, high and low

+

While viewing the waveform screen, the top button sets the high alarm limit, the bottom button sets the low alarm limit. For either limit, press the + side to raise the value or the – side to lower it. As you press one of these buttons, the values do not cycle through the available settings; e.g., when you reach 235, the value does not cycle (or wrap) to 30 or OFF and vice versa. When you are using menu options, these two buttons become function keys-the function each performs depends on the options available in the menu on the screen; see Menu button in chapter 2.

6 Display contrast adjuster Use this sliding lever to adjust the vertical viewing angle of the graphic display Slide the lever to the left to reduce the contrast and to the right to increase it.

7 Power/Standby button/AC power light This button toggles between On (operational mode) and Off (standby mode). The battery recharges as long as the unit is plugged into the AC power supply. No displays are visible in the Off/Standby mode. The green light to the right of the button is lit when the unit is connected to an AC power supply.

Battery operation The oximeter runs for at least five and one-half hours on a new, fully charged battery (somewhat less if the 3900P is printing) at normal operating temperatures. LOW BATTERY appears when between 5 and 15 minutes of battery operation time remain. Plug the monitor into AC power to continue monitoring and recharge the battery. The unit will operate with a dead or defective battery when it is connected to the AC power supply. When the CONNECT UNIT TO LINE POWER message appears, you must immediately plug the oximeter into the AC power supply or the unit turns itself off after 10 seconds.

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3900/3900P User’s Manual

When operating on battery power, an icon appears between the two pairs of alarm limit values on the right side of the LCD. (On Japanese menu screens, the icon appears at the upper right beside the first menu option.) This icon indicates the battery condition as follows:

85 130 40

Charged/not low Low If the all mute condition exists, the display of this icon alternates with the display of the all mute icon. This icon appears on the status screen: Depleted, not installed, or defective

8 Carrying handle The lower front portion of the oximeter’s case is designed to be a carrying handle for ease of moving the unit from one place to another.

9 Sensor connector The sensors for this oximeter plug into this nine-contact connector. Use only OxyTip+ sensors compatible with this oximeter (see Parts list in chapter 6).

10 Screen option buttons SpO2

PIr

These buttons access the following features: Press this button to return to the plethysmographic waveform when you are at any other screen. Press this button to view the main MENU. This menu provides options for entering custom patient labels for individual data records, for defining certain parameters, and for setting the current date and time. This menu also provides access to the modem features if a modem is installed. See Menu button in chapter 2 for detailed information. SpO2

1-10

PIr

Press the desired button to display SpO2 or PIr pulsatile value trend on the screen. See Trend options in chapter 2 for detailed information.

1/Overview

–♥+

11 Pulse beep volume button This button adjusts the volume level for the pulse indicator in incremental steps from OFF to level 5. The power-on default is 2 if SAVE LIMITS is set to NO (see SETTINGS in chapter 2). Press the + side of the button to increase the volume or the – side to decrease it; you will hear the volume level as you press the button. As you press one of these buttons, the values do not cycle through the available settings; e.g., when you reach 5, the value does not cycle (or wrap) to OFF and vice versa. As you adjust the volume, the volume setting is shown in the message area above the waveform. NOTE: The pitch of the pulse tone changes as the SpO2 value increases or decreases-the higher the SpO2 value, the higher the pitch of the pulse tone.

–

+

12 Alarm volume button This button adjusts the audible alarm volume level in incremental steps from 1 to 5. You cannot set the alarm volume to OFF. The power-on default is 3 if SAVE LIMITS is set to NO (see SETTINGS in chapter 2). Press the + side of the button to increase the alarm volume or the – side to decrease it; you will hear the volume level as you press the button. As you press one of these buttons, the values do not cycle through the available settings; e.g., when you reach 5, the value does not cycle (or wrap) to 1 and vice versa. As you adjust the volume, the volume setting is shown in the message area above the waveform.

13 Printer Monitoring data, current or trend, SpO2 or PIr pulsatile value, can be printed on the 3900P printer. See chapter 4 for specific operating instructions.

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