Model 2000 Pulse Oximeter Operators and Service Manual Rev 05

The following are trademarks of Masimo Corporation: Masimo® Masimo SET®, and LNOP®. Covered by one or more of the following U.S. Patents and foreign Equivalents: 5,337,744, 5,452,717, 5,482,036, 5,490,505. Possession or purchase of this device does not convey any express or implied license to use the device with replacement parts which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device.

Copyright © 1998 by Ivy Biomedical Systems, Inc., Branford, Connecticut. All rights reserved. No part of this manual may be reproduced without the permission of Ivy Biomedical Systems, Inc.

20001199 2411-00-20 REV 05

TABLE OF CONTENTS

TABLE OF CONTENTS

WARRANTY ...iii Description of Warning Labels ...iv INTRODUCTION ...1 SAFETY ...2 Electrical...2 Explosion ...2 Patient Connections...2 Measurements ...3 EMC ...3 MONITOR DESCRIPTION ...4 Specifications...4 Classification ...5 Controls and Indicators ...6 Fixed Keys ...6 On/Standby...6 Programmable Keys ...6 Display ...7 Waveform Display ...7 Alphanumeric Data ...7 Alarm Limits Display...7 Alarm Displays...7 Trend Displays ...7 Alarms ...8 Rear Panel ...8 Menu Structure...9 MONITOR SETUP ...10 Set Time and Date ...10 Audio Setup...10 Alarm Tone ...11 Trend Display ...11

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TABLE OF CONTENTS PULSE OXIMETRY MONITORING ...12 Principles of Operation ...12 Warnings/Cautions...14 Pulse Oximetry Sensors ...14 Monitoring Procedure...14 Alarm Limits...15 Response Settings...15 Default Values...15 Reset to Default Values ...15 ALARM MESSAGES ...16 Status Messages ...16 MONITOR TESTING ...17 BATTERY OPERATION...18 Battery Replacement ...18 CLEANING AND DISINFECTION...19 The Monitor ...19 Cleaning and Reuse of Sensors...19 Patient Cables ...20 ACCESSORIES...21 Reorder Numbers ...21 Instructions for use...22 Disposal...22 TESTING & TROUBLESHOOTING...27 Required Equipment ...27 Power Supply/Charges Tests ...27 Audio Tests...28 Safety Tests ...28 Rear Panel Connectors...29 ERROR MESSAGES...31 REPLACEMENT PARTS ...32 DISASSEMBLY & ASSEMBLY ...33 SCHEMATICS ... A BOARD LAYOUTS ... B

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Model 2000 Service Manual

WARRANTY

WARRANTY

All products manufactured by Ivy Biomedical Systems, Inc. are warranted to be free from defects in material and workmanship and to operate within published specifications, under normal use, for a period of one year from date of original shipment. LNOP® sensors purchased from Ivy Biomedical are warranted for 6 months. If an examination, by Ivy Biomedical Systems, Inc., discloses such products or component parts to have been defective, then our obligation is limited to repair or replacement (at our option). Fuses and batteries are not covered under this warranty.

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DESCRIPTION OF LABELS

Description of Labels Used Attention, consult ACCOMPANYING DOCUMENTS before attempting to change power supply selection or carry out interconnections. Equipment connected should comply with IEC-601-1 or IEC-950 with configuration to IEC-601-1-1. Protective earth (ground) adjacent to this symbol. Internal connection on mains connector/filter.

Equipotential earth connector adjacent to this symbol.

⎯⏐ ♥ ⏐⎯

_______

Type CF equipment, Defibrillator proof.

Fuse type/rating.

{ ⏐

{ = Power OFF, ⏐= Power ON.

∼

Alternate Current (AC)

~

ON – only for a part of equipment

z

{

STBY – off, only for a part of equipment

{

Contrast

iv

Model 2000 Service Manual

INTRODUCTION

INTRODUCTION

This manual is to provide information on the correct use of the Model 2000 Pulse Oximeter. It is up to the user to ensure that any applicable regulations respecting the installation and operation of the monitor are observed. The Model 2000 Pulse Oximeter is to be operated by qualified personal only. Using This Manual We recommend that you read this entire manual before operating the equipment. Use the Monitor Description section for general descriptions of controls and displays. For details on pulse oximetry, refer to the section of the manual dealing with that parameter. NOTE: If the monitor beeps when you press a key, it indicates an invalid selection for the current mode or function. Boldface type is used in text to refer to the labeling on user controls. Special brackets [ selections used with the programmable keys.

] surround menu

Manufacturer’s Responsibility The manufacturer of this equipment is responsible for the effects on safety, reliability, and performance of the equipment only if: •

assembly operations, extensions, re-adjustments, or repairs are carried out by persons authorized by the manufacturer

•

the electrical installation complies with all applicable regulations

•

the equipment is used in accordance with the instructions in this manual

Incorrect operation or failure of the user to maintain the monitor in accordance with proper maintenance procedures relieves the manufacturer or his agent from all responsibility for consequent non-compliance, damage, or injury. For technical and service information, please refer to the Ivy Model 2000 Operator's/Service Manual or contact: Ivy Biomedical Systems, Inc. 11 Business Park Drive Branford, Connecticut 06405 (203) 481-4183 or (800) 247-4614 e-mail:[email protected] This manual explains how to set up and use the Model 2000 Pulse Oximeter. Important safety information relating to general use of the pulse oximeter appears in this manual. Other important safety information is located throughout the manual where appropriate. READ THE ENTIRE SAFETY INFORMATION SECTION BEFORE YOU OPERATE THE PULSE OXIMETER.

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SAFETY

SAFETY

Electrical Medical Electrical Equipment. Classified by Underwriters Laboratories Inc. ® with respect to electric shock, fire, mechanical and other specified hazards only in accordance with UL2601-1 CAN/CSA C22.2 No. 601.1.

This product is intended to be operated from a mains power source of nominally 100 V ~ to 230 V ~, 47-63 Hz, or from its internal battery. WARNING: For continued protection against fire hazard, replace only with same type and rating of fuse. Fuse value is T 1A 250V 5 mm x 20 mm.

WARNING: To prevent electrical hazards to all personnel, this monitor must be properly grounded. The power cable supplied with this equipment provides for this protection. Do not attempt to defeat this protection by modifying the cable or by using ungrounded adapters. Do not connect to an electrical outlet controlled by a wall switch or dimmer.

WARNING: Electric shock hazard! Do not remove covers or panels. Refer service to qualified service personnel.

WARNING: To avoid electrical shock, disconnect the monitor from its power source before changing fuses.

WARNING: Do not clean monitor while it is on and/or plugged in. WARNING: When attached to other devices, insure that the total chassis leakage currents of all units do not exceed 300µA.

Explosion DANGER: Explosion hazard! Do not use this equipment in the presence of flammable anesthetics.

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Model 2000 Service Manual

SAFETY

Patient Connections Leakage current is limited internally by this monitor to less than 10 µA. However, always consider additional leakage current that can be caused by other equipment used on the patient at the same time as this monitor. Carefully route patient cables to reduce the possibility of patient entanglement or strangulation.

Measurements If the accuracy of any measurement does not seem reasonable, first check the patient’s vital signs by alternate means and then check the Model 2000 Pulse Oximeter for proper functioning. Inaccurate measurements may be caused by: •

Incorrect sensor application or use

•

Significant levels of dysfunctional hemoglobins (e.g., carboxyhemoglobin or methemoglobin) – see note.

•

Intravascular dyes such as indocyanine green or methylene blue – see note.

•

Exposure to excessive illumination, such as surgical lamps (especially ones with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, or direct sunlight (exposure to excessive illumination can be corrected by covering the sensor with a dark or opaque material)

•

Excessive patient movement

•

Venous pulsations

•

Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line

The Model 2000 can be used during defibrillation, but the readings may be inaccurate for a short time. Loss of pulse signal can occur in any of the following situations: •

The sensor is too tight

•

There is excessive illumination from light sources such as a surgical lamp, a bilirubin lamp or sunlight

•

A blood pressure cuff is inflated on the same extremity as the one with a SpO2 sensor attached

•

The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia

•

There is arterial occlusion proximal to the sensor

•

The patient is in cardiac arrest or is in shock

NOTE: A pulse oximeter measures functional hemoglobin saturation. This is different to an arterial blood gas that measures fractional hemoglobin saturation. Differencies can occur when significant levels of HbCO (carboxyhemoglobin), HbMET (methomoglobin) indocynanine green or methylene blue exist.

EMC This equipment has been certified to be protected to emissions and immunity according to IEC-601-1-2.

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MONITOR DESCRIPTION

MONITOR DESCRIPTION The Model 2000 Pulse Oximeter is intended for continuous noninvasive monitoring of functional oxygen saturation or arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients in a hospital and mobile environment within the hospital.

Specifications Performance Range: Saturation (%SpO2) Pulse Rate (bpm)

1% - 100% 25 - 240

Accuracy: Saturation (%SpO2) – During no motion conditions Adults 70% - 100% ± 2 digits 0% - 69% unspecified Neonates 70% - 100% ± 3 digits Saturation (%SpO2) – During motion conditions Adults 70% - 100% ± 3 digits 0% - 69% unspecified Pulse (bpm) – During no motion conditions 25 to 240 ± 3 digits Pulse (bpm) – During motion conditions 25 to 240 ± 5 digits Resolution Saturation(%SpO2) Pulse Rate (bpm)

1% 1

Type:

Backlit LCD

Pixels:

240 x 64 dots

Dot Pitch:

0.53 mm

Data Displayed:

Pulse rate, SpO2 %, Pleth wave, Alarms, Trends, Status messages

Display

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Model 2000 Service Manual

MONITOR DESCRIPTION Power Requirements Voltage Input Range:

100-230 V~, 47-63 Hz

Maximum AC Power Consumption:

55 VA

Communications Serial Port RS232, 9600 baud Mechanical Size:

4.26in (10.65cm)H x 9.75in (24.4cm) W x 9.75in (24.4cm) D

Weight:

6.5 lbs (2.95 kg)

Type:

Sealed gel cell, DOT and IATA approved

Operating Time:

2 hours

Charge Time:

<8 hours

Battery

Classification (in accordance with IEC601-1) Protection against electric shock:

Class 1 equipment

Degree of protection against electric shock:

Type CF equipment

Degree of protection against harmful ingress of water:

Drip-proof equipment

Methods of sterilization or disinfection:

See page 19

Degree of safety of application in the presence of a famable anaesthetic mixture with air or with oxygen or nitrous oxide:

Mode of operation:

Model 2000 Service Manual

Equipment not suitable for use in the presence of a fammable anaesthetic mixture Continuous

5

MONITOR DESCRIPTION

Controls and Indicators Fixed Keys Displays menus for all pulse oximeter settings. See the Menu Structure section of this manual for a description of the menus.

Turns the alarm audio on and off. Press once to silence the alarms for 120 seconds (two minutes). Press and hold for five seconds to silence the alarms until this button is pressed again. On/Standby: Controls power to the monitor’s electronic circuits. The rear panel mains switch must be on for this key to be effective.

Programmable keys Each of the keys below the display has a normal function, printed on the key, and several menu functions displayed on the screen in the setup mode. The normal functions are described below. Menu functions are described in the menu descriptions later in this manual.

Resets the audible and visual indicators for an alarm that has been activated.

Displays Trend data. To define the trend display, see the trend display setup instructions.

Adjusts the contrast of the display. Press for small adjustments. Press and hold for larger adjustments

Initiates a printout from the optional printer.

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Model 2000 Service Manual

MONITOR DESCRIPTION

Display Waveform Display The plethysmographic waveform is displayed from left to right. Alphanumeric Data The following data appears on the display: Pulse Rate- Lower left-hand corner of the display – values updated once per second. Oxygen Saturation (SpO2) - To the left of the waveform – values updated once per second. Alarm Limits Display SpO2 Alarm limit settings are displayed to the right of the SpO2 reading. Pulse rate alarm limit settings are displayed to the right of the pulse rate reading. Alarm Displays When an alarm setting has been exceeded, a flashing alarm tag appears on the screen, indicating which alarm has been triggered. Trend Displays Graphic display of up to 24 hours of averaged saturation. The pleth waveform is not displayed while the trend is displayed.

Upper/Lower SpO2 Limits

SpO2 % BPM

98

99 90

70

150 50

LIMITS

VOLUME

DATE/TIME

Red LED alert window

RESPONSE

Upper/Lower Pulse Rate Limits

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MONITOR DESCRIPTION

Alarms The following is a list of alarms and ranges for which they can be set. When the alarm triggers. Audio alarm tone sounds if the ALARM PAUSE button has not been activated. Pressing ALARM RESET turns off any alarms that have triggered. If the measurement returns to within the limits, the alarm turns off. The ALARM PAUSE key disables the alarms for two minutes or until ALARM PAUSE is pressed again. High Pulse Rate: 50 to 235 bpm in 5 bpm increments Low Pulse Rate: 30 to 150 bpm in 5 bpm increments High SpO2: 70 to 99%in 1% increments Low SpO2: 50 to 95% in 1% increments Sensor Off: The sensor is not properly attached to the patient.

Rear Panel The following are located on the rear panel. COM 1: A digital interface for network communication (see note). PRINTER: A connection for the optional printer (see note). MAINS (A.C.) POWER SWITCH: A switch to control mains power input to the monitor. PEQ GROUND: Potential Equalization- A ground connection that can be used to ensure that no potential differences can develop between this equipment and the other electrical equipment.

Note: When using COM1 or PRINTER rear panel connectors, the Ferrite Filter Adaptor Connector must be used. Ivy Biomedical accessory part number 150027 Note: Parts and accessories used must meet the requirements of the applicable IEC 601 series safety standards and essential performance standards, and/or the system configuration must meet the requirements of the IEC 601-1-1 medical electrical systems standard. ACCESSORIES (EQUIPMENT) – The use of ACCESSORY equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include: • use of the accessory in the PATIENT VICINITY; and • evidence that the safety certification of the ACCESSORY has been performed in accordance to the appropriate IEC 601-1 and/or IEC 601-1-1 harmonized national standard.

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Model 2000 Service Manual

MONITOR DESCRIPTION

Menu Structure Settings for all options for the Model 2000 are made through a series of menus that appear at the bottom of the display. You access the menus by pressing the MENU key. When menus are displayed, press MENU again to return to normal display. NOTE: If the monitor beeps when you press a key, it indicates an invalid selection for the current mode or function. Press MENU to display the main menu, which allows you to select alarm limits, volume, date/time, and response menus. When the main menu is displayed, press MENU again to return to normal display.

SpO2% BPM

98

99 90

70

150 50

LIMITS

Main Menu

Model 2000 Service Manual

VOLUME

DATE/TIME

RESPONSE

Soft Keys

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MONITOR SETUP

MONITOR SETUP To setup the instrument for operation: 1.

Plug the ac line cord into a power source providing the proper voltage and make sure the rear panel power switch is in the ON position.

2.

Press the ON/STBY push button at the left of the front panel. If the internal battery is completely dead wait one minute before pressing the ON/STBY push button.

3.

Connect the sensor and the pulse oximetry cable to the SpO2 connector on the front panel.

Set Time and Date 1.

Press the MENU key to display the main menu. Then select [DATE/TIME].

2.

The first setting is for MONTH. Use the

3.

Select [SET MONTH] to move to the DAY setting. Use the setting.

4.

Select [SET DAY] to move to the YEAR setting. Use the setting.

and

keys to increase or decrease the year

5.

Select [SET YEAR] to move to the HOUR setting. Use the setting.

and

keys to increase or decrease the hour

6.

Select [SET HOUR] to move to the MINUTE setting. Use the minute setting.

7.

When all date and clock settings are correct, select [ENTER] to enter the settings into the monitor’s memory.

8.

Press MENU to return to normal display.

and

keys to increase or decrease the month setting. and

keys to increase or decrease the day

and

keys to increase or decrease the

Audio Setup 1.

Press the MENU key to display the main menu.

2.

Select [VOLUME] to display the menu for setting pulse and alarm volume.

3.

Adjust the pulse volume using [PULSE

10

and

] keys – OFF, 20%, 40%, 60%, 80% or 100%.

Model 2000 Service Manual

MONITOR SETUP 4.

Adjust the alarm volume using [ALARM

5.

Press MENU to return to the normal display.

and

] keys – 20%, 40%, 60%, 80% or 100%.

Alarm Tone To change the alarm tone: 1.

Press the ON/STBY push button to put the monitor in Stand-by.

2.

Press and hold the TREND key while simultaneously pressing ON/STBY push button.

3.

Adjust the alarm tone using [ALM TONE

4.

Press the MENU key to return to normal display.

and

] keys - LOW, MEDIUM or HIGH.

Trend Displays The Model 2000 has a trend display showing SpO2. Time selections for this trend display are 30min, 2, 8, 12 and 24 hours. Trend Setup 1.

Press the TREND key to select 30min., 2, 8, 12 or 24 hour trend.

2.

Press TREND to return to the normal display.

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PULSE OXIMETRY MONITORING

PULSE OXIMETRY MONITORING Overview Pulse oximetry allows you to continuously and noninvasively monitor a patient’s hemoglobin oxygen saturation.The oximetry sensor contains two light emitting diodes (LEDs) that transmit specific wavelengths of light which are received by a photodetector. Oxygen saturated blood absorbs light differently as compared to unsaturated blood. Thus the amount of light absorbed by blood can be used to calculate the ratio of oxygenated hemoglobin to total hemoglobin in arterial blood. The monitor displays this ratio as percent SpO2. Normal values typically range from 95 to 100% at sea level.

Principles of Operation The Model 2000 Pulse Oximeter is based on three principles: 1.

Oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light (spectrophotometry).

2.

The volume of arterial blood in tissue and the light absorbed by the blood changes during the pulse (plethysmography).

3. Arterio-venous shunting is highly variable and that fluctuating absorbance by venous blood is a major component of noise during the pulse. The Model 2000 Pulse Oximeter as well as traditional pulse oximetry determines SpO2 by passing red and infrared light into a capillary bed and measuring changes in light absorption during the pulsatile cycle. Red and infrared light-emitting diodes (LEDs) in oximetry sensors serve as the light sources, a photodiode serves as the photodetector. Traditional pulse oximetry assumes that all pulsations in the light absorbance signal are caused by oscillations in the arterial blood volume. This assumes that the blood flow in the region of the sensor passes entirely through the capillary bed rather than through any arterio-venous shunts. The traditional pulse oximeter calculates the ratio of pulsatile absorbance (AC) to the mean absorbance (DC) at each of two wavelengths, 660 nm and 940 nm. S(660) = AC(660)/DC(660) S(940) = AC(940)/DC(940) The oximeter then calculates the ratio of these two arterial pulse-added absorbance signals: R = S(660)/S(940) The value of R is used to find the saturation SpO2 in a look-up table built into the oximeter’s software. The values in the look-up table are based upon human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hypoxia studies.

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Model 2000 Service Manual

PULSE OXIMETRY MONITORING The Model 2000 Pulse Oximeter assumes that arterio-venous shunting is highly variable and that fluctuating absorbance by venous blood is the major component of noise during the pulse. The 2000 decomposes S(660) and S(940) into an arterial signal plus a noise component and calculates the ratio of the arterial signals without the noise: S(660) = S1 + N1 S(940) = S2 + N2 R = S1/S2

Again, R is the ratio of two arterial pulse-added absorbance signals and its value is used to find the saturation SpO2 in an empirically derived equation into the oximeter’s software. The values in the empirically derived equation are based upon human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hypoxia studies. The above equations are combined and a noise reference (N’) is determined: N' = S(660) - S(940) x R If there is no noise N' =0; then S(660) = S(940) x R which is the same relationship for the traditional pulse oximeter. The equation for the noise reference is based on the value of R, the value being seeked to determine the SpO2. The Model 2000 software sweeps through possible values of R that correspond to SpO2 values between 1% and 100% and generates an N' value for each of these R values. The S(660) and S(940) signals are processed with each possible N' noise reference through an adaptive correlation canceler (ACC) which yields an output power for each possible value of R (i.e., each possible SpO2 from 1% to 100%). The result is a Discrete Saturation Transform (DSTTM) plot of Relative output power versus possible SpO2 value as shown in the following figure, where R corresponds to SpO2 = 97%. The red light power range is 1mw to 3 mw. The infrared light power range is 0.7mw to 3mw.

The DST plot has two peaks: the peak corresponding to the higher saturation is selected as the SpO2 value. This entire sequence is repeated once every two seconds on the most recent four seconds of raw data. The Model 2000 Model 2000 Service Manual

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PULSE OXIMETRY MONITORING SpO2 therefore corresponds to a running average of arterial hemoglobin saturation that is updated every two seconds. WARNING: The pulse oximeter should NOT be used as an apnea monitor. WARNING: The pulse oximeter should be considered an early warning device. If a trend towards patient deoxygenation is indicated, blood samples should be analyzed by a laboratory co-oximeter to completely understand the patient’s condition. Caution: Use only sensors specified by Ivy Biomedical Systems, Inc. If you use sensors other than those specified, it might degrade perfomance and could damage the pulse oximeter. Caution: Check the sensor site frequently. Do not allow the sensor to remain on one site for a prolonged period of time, especially when monitoring neonates. Refer to the sensor’s specific instructions. Caution: Never attach a SpO2 sensor on a limb being monitored with a blood pressure cuff or a limb with restricted blood flow. Caution: A poorly applied sensor might give incorrect saturation values. Reapply the sensor. Caution: Choose a site with sufficient perfusion to ensure accurate oximetry values. Caution: Certain nail aberrations, nail polish, fungus, etc. might give inaccurate oximetry values. Remove the nail polish and/or move the sensor to an unaffected digit. Caution: Do not use the Model 2000 Pulse Oximeter or sensors during Magnetic Resonance Imaging (MRI).

Pulse Oximetry Sensors To ensure conformance with all safety and performance specifications, use only the Masimo® LNOP pulse oximetry sensors.

Monitoring Procedure Use the following procedure for monitoring pulse oximetry: 1.

Choose a site that is well perfused and provides proper alignment of the LEDs and receiving photodetector Select a site that has unrestricted blood flow Do not restrict blood flow when securing sensor with tape

Select an appropriate sensor and apply it to the patient, following the directions for use provided with the sensor Do not select a site near potential electrical interference (electrical cords, for example). 2.

Connect the cable to the monitor’s SpO2 input.

3.

Plug the extension cable into the sensor.

4.

Use the procedures described in the following sections for alarm limit settings, response mode settings, and enabling or disabling the SpO2 alarm.

Alarm Limits 1.

14

Press the MENU key to display the main menu.

Model 2000 Service Manual