GE Healthcare 3900P, 3900 User Manual

GE Healthcare

3900/3900P Pulse Oximeter

TruTrak®+

User’s Manual

♥

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

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

Table of Contents

2/Setup and Operations

Powering the oximeter...............................................................................................................................2-1

Setup....................................................................................................................................................................2-2

Factory settings..................................................................................................................................2-2

Mode switch settings......................................................................................................................2-3

Checkout procedure...................................................................................................................................2-5

Signal and data validity............................................................................................................................2-8

Plethysmographic waveform.....................................................................................................2-8

Numeric display............................................................................................................................2-10

Waveform screen button.......................................................................................................................2-11

Menu button.................................................................................................................................................2-11

Main menu function key buttons.........................................................................................2-11

LABELS............................................................................................................................................................2-12

Locking label lines........................................................................................................................ 2-14

SETTINGS.....................................................................................................................................................2-15

Date and time...............................................................................................................................................2-17

Trend options...............................................................................................................................................2-18

Trend function keys.....................................................................................................................2-19

Trend data ......................................................................................................................................... 2-20

Patient function key lockout...............................................................................................................2-22

Before powering on the oximeter ..............................................................................2-2

After powering on the oximeter .................................................................................2-2

Language selection.............................................................................................................2-3

Averaging mode...................................................................................................................2-4

PIr pulsatile value display.............................................................................................2-4

EMI line frequency ............................................................................................................2-4

Low perfusion.......................................................................................................................2-8

Signal noise............................................................................................................................2-9

SpO2........................................................................................................................................2-10

Pulse rate .............................................................................................................................. 2-10

PIr pulsatile value............................................................................................................2-10

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

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..........................................................................................................................................2-17

Time.........................................................................................................................................2-17

Scroll buttons.........................................................................................................2-19

Shift buttons...................................................................................................2-19

CLEAR....................................................................................................................................2-19

Viewing time scale for display................................................................................. 2-20

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

Safety checks for software...........................................................................................................7-2

Specifications..................................................................................................................................................7-3

Circuitry.................................................................................................................................................7-3

Audio indicators................................................................................................................................7-3

Audible alarms..................................................................................................................................7-3

Displays..................................................................................................................................................7-4

Mode switch........................................................................................................................................7-4

SpO2.........................................................................................................................................................7-4

Pulse rate...............................................................................................................................................7-5

PIr pulsatile value............................................................................................................................7-5

Sensor emitter wavelength ranges.........................................................................................7-5

Environmental....................................................................................................................................7-5

Electrical................................................................................................................................................7-5

RS-232 serial/analog connector................................................................................................7-6

Dimensions and weight ................................................................................................................7-6

Electromagnetic effects....................................................................................................7-2

Alarm limits ...........................................................................................................................7-3

Interfering substances......................................................................................................7-4

Battery........................................................................................................................................7-5

Power.........................................................................................................................................7-6

Current leakage....................................................................................................................7-6

Fuses...........................................................................................................................................7-6

Serial output ..........................................................................................................................7-6

Analog output........................................................................................................................7-6

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

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

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),

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.

messages, the Relative Perfusion Index (PI and low alarm limit settings for SpO2 and pulse rate.

Important: Only OxyTip

+ sensors can be used with this monitor.

) pulsatile value, and the high

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

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

1-1

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 PI 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

• PerfTrak® waveform display, an automatic scale of the plethysmographic

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

• Backlit display and contrast control for excellent visibility in subdued lighting

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

• An audible pulse indicator with an adjustable volume; the automatic pitch

• 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

• Automatic tiered alarm messages.

• Language options that display the monitor’s screen text and, in most cases,

• Short, medium, or long SpO2 response averaging modes.

• Automatic storage of alarm conditions and up to 24 hours of SpO2, pulse rate,

waveform to provide a relative indication of the sensor site perfusion level.

conditions; adjustable viewing angle, using the pull-down feet under the monitor.

rate.

modulation reflects changing SpO2 level.

to mute all alarms can be disabled.

printed or transmitted data in the selected language.

and PIr pulsatile value data.

1-2

• 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

1/Overview

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

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.

Analog

Processing

A/D

Converter

Digital

Processing

Input/

Output

1-3

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 SpO

Absorption

Variable absorption (due to arterial pulse)

Arterial blood absorption

Venous blood 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

Extinction (10x)

(Infrared)

940 nm

1-4

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/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 =

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

Functional SpO2 =

The calculation of SpO 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.

( )

TOTAL

( )

TOTAL

assumes 1.6% carboxyhemoglobin (COHb), 0.4%

x 100 =

O2Hb

– COHb – MetHb

( )

O2Hb + HHb + COHb + MetHb

O2Hb

x 100 =

x 100

O2Hb

( )

O2Hb + HHb

x 100

1-5

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 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)

1-6

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 SpO

Pulse rate numeric area—calculated pulse rate

1-7

3900/3900P User’s Manual

3 Graphic display

1 Plethysmographic waveform (also the display area for trend data, screen

2 Message area.

3 SpO2 and pulse rate alarm limits

1.25

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.

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.

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.

130

1-8

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.

SpO

♥

1/Overview

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.

1-9

3900/3900P User’s Manual

130

8 Carrying handle

9 Sensor connector

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:

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

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.

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).

SpO

10 Screen option buttons

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.

SpO

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

information.

1-10

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.

1-11

3900/3900P User’s Manual

Rear panel

Figure 1-5. 3900/3900P Pulse Oximeter rear panel

WARNING: Electrical shock hazard. Because the unit is not grounded when it is operating on battery power, do not connect any equipment to the RS-232 connector on the rear panel unless the unit is connected to the AC power supply.

1 Power entry module

12 3 45

This module contains

• Fuses

• Power connector for the power cord that connects the oximeter to the

AC power supply for continuous operation and/or battery recharging.

Mode Switch

RS 232

2 Equipotential ground connector

In locations where this type of ground is required, connect your grounding system here.

3 Product information label

Refer to Compliance with standards in chapter 7 for definitions of symbols tha indicate compliance with standards set by regulatory agencies.

4 Mode Switch

This symbol identifies the two-position switches that set the display language, the averaging mode, the display of the PIr pulsatile value, and the EMI line frequency. See chapter 2 for instructions.

5 RS-232 serial/analog connector

This 9-pin connector provides:

• Serial information on SpO2, pulse rate, PIr pulsatile value, alarm limit

violations, and alarm messages with a time stamp and custom patient label. The connector is compatible with most serial communication devices; see Appendix B for instructions.

• Analog information on SpO2 and pulse rate waveform. Using the Datex-

Ohmeda modem/analog cable, the monitor can output data to a chart recorder or polysomnography machine; see Appendix B for instructions.

• Serial information through a modem, using the Datex-Ohmeda

modem/analog cable. Data can be output to a fax machine or computer. For details, see chapter 5.

1-12

Precautions

Warnings

1/Overview

Two types of precautions appear in this manual: warnings and cautions.

• A WARNING indicates the possibility of injury to the patient or operator.

• A CAUTION indicates a condition that may lead to equipment damage or

malfunction.

NOTE: If you connect a modem, refer to the precautions contained in the instructions you received with your modem.

Failure of operation

If the oximeter fails any part of the checkout procedures or current leakage test, remove it from operation until qualified service personnel have corrected the situation.

It is possible for any device to malfunction; therefore, always verify unusual data by performing a formal patient assessment.

Data validity

Conditions that may cause inaccurate readings and impact alarms include interfering substances, excessive ambient light, electrical interference, excessive motion, low perfusion, low signal strength, incorrect sensor placement, poor sensor fit, and movement of the sensor on the patient.

To prevent erroneous readings, do not use an inflated blood pressure cuff or arterial blood pressure measurement device on the same limb as the oximeter sensor.

Explosion hazard

Do not use the monitor in the presence of any flammable anesthetic mixture.

Electrical shock hazard

Do not remove the monitor cover. An operator may only perform maintenance procedures specifically described in this manual. Refer servicing to qualified service personnel trained in the repair of this equipment.

Measure the oximeter’s leakage current whenever an external device is connected to the RS-232 port. Forward and reverse polarity = 100 microamperes maximum.

This equipment must be properly grounded.

• Electrical safety specifications (e.g., current leakage and ground resistance) can be assured only when the monitor is connected to a three-wire, grounded receptacle without the use of extension cords or adapters.

• If there is any doubt about the integrity of the AC power supply protective earth conductor, operate the monitor on internal battery power.

• Because the unit is not grounded when it is operating on battery power, do not connect any equipment to the RS-232 connector on the rear panel unless the unit is connected to the AC power supply.

1-13

3900/3900P User’s Manual

Electrical shock and flammability hazard

Before cleaning or servicing the oximeter, always turn it off and disconnect the power cord from the AC power supply.

Patient safety

The correct use of the oximeter is to measure only arterial oxygen saturation (SpO2), pulse rate, and Relative Perfusion Index pulsatile value.

• A pulse oximeter does not measure respiration and should never be used as a

• A pulse oximeter may be used during sleep studies of adults only to gather

This device is not intended for use in a magnetic resonance imaging (MRI) environment.

Patient safety (sensors)

Patient conditions (such as reddening, blistering, skin discoloration, ischemic skin necrosis, and skin erosion) may warrant changing the sensor site frequently or using a different style of sensor.

substitute for an apnea monitor or as the primary monitor for infants being monitored for apnea.

information regarding SpO2, pulse rate, and PIr pulsatile value.

To prevent patient injury or equipment damage, use only OxyTip+ oximeter sensors approved for use with this oximeter. For complete information about the safe and appropriate use of a sensor, consult the instructions for that sensor.

Discard a damaged sensor immediately. Do not repair a damaged sensor or use a sensor repaired by others.

Patient safety (modem)

Do not use the modem within the patient environment defined below:

)

f 2

. 8

( m

. 2

1.5 m (5 ft)1.5 m (5 ft)

)

(

Do not connect the modem to the oximeter when the oximeter is operating on battery power.

RS-232 system interconnection

Accessory equipment connected to the RS-232 serial/analog connector must be certified according to the current version of the respective IEC/EN standards (e.g., IEC 60950 for data processing equipment and IEC/EN 60601-1 for medical equipment). All configurations shall also comply with IEC/EN 60601-1-1. Anyone who connects additional equipment to the RS-232 serial/analog connector configures a medical system, and is therefore responsible that the system complies with the requirements of IEC/EN 60601-1-1. If in doubt, call your local authorized

1-14

Cautions

1/Overview

service office. The 3900/3900P is referred to as an IEC/EN 60601/F device in the summary of situations table contained in IEC/EN 60601-1-1.

Handle the monitor with care

Improper handling can cause damage or inaccurate results.

Cleaning

Do not autoclave, pressure sterilize, or gas sterilize this oximeter.

Use cleaning solution sparingly. Do not soak or immerse the monitor in liquid. Excessive solution can flow into the monitor and damage internal components.

When cleaning the display area, do not use abrasive cleaning compounds or other materials that could damage the screen.

Do not use petroleum-based solutions, acetone solutions, or other harsh solvents to clean the oximeter. These substances may damage the oximeter and cause a malfunction.

To prevent damage to the 3900P printer, do not allow any cleaning solution to get into the printer mechanism.

Sensors

Do not apply tension to the sensor cable; sensor damage may result.

Battery

The 3900/3900P internal battery, containing lead and acid, is a hazardous waste. Dispose of the battery through an approved hazardous materials disposal facility or return it to Datex-Ohmeda for disposal.

To prevent damage to the lead-acid battery, do not turn the monitor on after the LOW BATTERY message appears without first plugging it in to the AC power supply.

Printer

To avoid damage to the print head, do not operate the printer without paper. Paper purchased from Datex-Ohmeda has red edges when the paper roll is nearing depletion.

To avoid damage to the printer, never pull the paper backward through the printer mechanism.

To avoid damaging the printhead mechanism, discharge any possible static electricity from your person before removing the paper feed cover on the printer.

Disposal

Dispose of this medical device and its packing materials according to local requirements.

1-15

3900/3900P User’s Manual

1-16

2/Setup and Operations

This chapter provides the following information and instructions:

• Powering the oximeter.

• Selecting the language, averaging mode, PIr pulsatile value display, and EMI

(electromagnetic interference) line frequency.

• Checkout procedure—to determine that all functions of the 3900/3900P oximeter are working properly.

• Signal and data validity guidelines.

• Menu options.

• Trend data options; SpO2 and PIr pulsatile value.

• Lock-buttons procedure—to prevent changes to the monitor’s settings.

To operate the 3900/3900P oximeter effectively, you must

• Know how the oximeter derives its readings (see Principles of operation in chapter 1).

• Be familiar with its controls and components (see chapter 1).

• Understand its messages (see chapter 3).

Powering the oximeter

The 3900/3900P pulse oximeter is designed to operate on battery power and on all commonly available voltage supplies. Your oximeter was shipped with the correct power cord for your local AC power supply. Any hospital-grade power cord, however, with the female connector end that fits into the power module (IEC-320 type) on the 3900/3900P can be used; the male connector that plugs into the grounded “wall” outlet may be whatever is needed locally. The oximeter accepts a range of AC mains power; see chapter 7 for details.

To protect data validity in cases of possible electromagnetic interference, make sure the EMI line frequency mode switch is set to the same frequency as your local AC power supply before using the unit for patient monitoring; see EMI line frequency under Mode switch settings later in this chapter.

A battery does not need to be installed for the oximeter to operate on the AC power supply.

2-1

3900/3900P User’s Manual

Setup

Factory settings

When you turn on the oximeter, the following settings are in effect and remain in operation until you change them.

Before powering on the oximeter

Use the mode switches in the oximeter’s rear panel to set the language, averaging mode, PIr pulsatile value display, and EMI line frequency.

Parameter Factory Setting Range

Language English Danish, Dutch, English, Finnish, French,

German, Italian, Japanese, Norwegian, Polish, Portuguese, Spanish, or Swedish

Averaging mode

PIr pulsatile value display Yes Yes (display PIr value) or No

EMI line frequency 60 Hz 50 Hz or 60 Hz

Long / TruTrak+

(12 seconds)

Long / TruTrak+ (12 seconds), Medium (6 seconds), or Short (3 seconds)

After powering on the oximeter

Changes you make to the parameters shown below take effect immediately.

Parameter Factory Setting Range

High SpO2 limit OFF

(appears as: – – –)

Low SpO2 limit 85% 50% to 100% or OFF

High pulse rate 130 bpm* 30 to 235 bpm or OFF

Low pulse rate 40 bpm 30 to 235 bpm or OFF

Alarm volume 3 1 to 5

Pulse volume 2 1 to 5 or OFF

Save limits NO YES or NO

All mute YES YES (enabled) or NO (disabled)

50% to 100% or OFF

2-2

Serial transmission baud rate 9600 9600, 19.2K, 38.4K, or 57.6K

Data output mode

(printer and modem)

Data output resolution 6-second interval 6- or 30-second intervals

Print contrast 5 1 through 10

Date format DD/MM/YY MM/DD/YY, DD/MM/YY, YY/MM/DD

* bpm= beats-per-minute

SpO

SpO2 or PI

Mode switch settings

A bank of eight numbered, two-position switches is accessed through the rear panel. The up position is ON and the down position is OFF.

2/Setup and Operations

Important: If you change the switch settings while the oximeter is on, the new settings do not take effect until you power off, then on again.

Language selection

Switches 1, 2, 3, and 4 set the language used for the display, 3900P printer output, and data transmitted through the RS-232 port. (For Japanese, printer output and data transmissions are in English only.)

Switches Language

1234

Danish

1234

Dutch

1234

English

1234

Finnish

1234

French

1234

German

Italian

Japanese

Norwegian

Polish

Portuguese

Spanish

Swedish

2-3

3900/3900P User’s Manual

Averaging mode

Switches 5 and 6 set the averaging mode. The averaging mode selects the time period of data used to calculate a weighted average SpO2 value to be displayed by the oximeter.

Switches SpO2 and Pulse Rate Averaging

Long (12 seconds) Yes (enabled)

Medium (6 seconds) No

Short (3 seconds) No

PIr pulsatile value display

Switch 7 sets the display of the PIr pulsatile value.

Switch Display PIr value

Yes

TruTrak+

EMI line frequency

Switch 8 sets the EMI line frequency. To optimize EMI (electromagnetic interference) immunity, make sure switch 8 is in the correct position for the AC power line frequency in use.

Switch EMI Line Frequency

60 Hz

50 Hz

2-4

+ 77 hidden pages