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LIFECARE® 5000 PLUM™ INFUSION SYSTEM WITH CONCURRENT DELIVERY FEATURE #2507-54 TECHNICAL SERVICE MANUAL Abbott Laboratories North Chicago, IL 60064 430-03426-002 Version 1.50 Series Copyright © 1990 Abbott Laboratories All Rights Reserved ‘This document and the subject matter disclosed herein are proprietary information. Abbott Laboratories retains all the exclusive rights of dissemination, reproduction, manufacture and sale. Any party using this document accepts it in confidence, and agrees not to duplicate it in whole oF in part nor disclose it to others without the written consent of Abbott Laboratories TABLE OF CONTENTS 1.0 INTRODUCTION .. 1.1 ABOUT THIS MANUAL 1.2 USER QUALIFICATION 1.3 WARNINGS, CAUTIONS, AND NOTES 2.0 SPECIFICATIONS .. 3.0 SYSTEM OPERATING MANUAL (Not Included) . . 4.0 THEORY OF OPERATION . 4.1 OPERATIONAL OVERVIEW ... 4.2 INFUSER STATUS CONDITIONS . 4.21 OFF... 4.2.2 SELF-TEST ... 4.2.3 SET-UP/OPERATING ‘Set-Up/Operating Activity States . 4.2.4 BATTERY OPERATION Infuser Battery Operating Sequence Battery Operation Comments 4.2.5 SYSTEM MALFUNCTION CORE FAILURE State .. PERIPHERAL FAILURE State 4.3 DATA RETENTION ..... 4.3.1. Critical Data Retention . . 4.3.2 Alarm History Data .. 4.4 ELECTRONCS: AN OVERVIEW ... 4.4.1 Main PWA: A Functional Description . Microprocessor Unit (MPU) and Clock . .. Second Clock Source EPROM, RAM, and Memory Protection Custom Discrete Logic IC ... ‘Analog-to-Digital Conversion Supply Voltage Conversion 4.4.2. VO PWA: A Functional Description Logic and Control on @ Custom IC......... Circuitry tor Motor Drives. Nurse-Call Relay Control Delivery Mode Selection iit 430-03426-002 4.4.3 4.4.4 4.4.5 4.4.6 4,5 MECHANICS: AN OVERVIEW Power Supply PWA: A Functional Description Unreguiated DC Power Supply ...+ AC-line and Battery Power Indicators Power Control Logic and Motor Power Supply Regulation Audible Alarm Seif Battery Charging Battery Detector ‘Sensor PWA: A Functional Description . Optical interrupters ‘Transducer Driver . 4-30 Pressure Amplifier 4-31 Cassette Switch . 4-31 Bubble Sensor PW A Functional Description Preamplifier .....- AM Detector - ‘Threshold Detector .. Reference Network Display PWA: A Functional Description - Character LEDs and Drivers tcp... Current Sense Amplifier . ‘Analog Multiplexer 4.5.1 The Cassette: A Functional Description . 4.5.2. The Mechanism Assembly: A Functional Description 4-40 Motors and Valves ... 4-41 4.6 MONTORS AND DETECTORS: An Overview . 4.6.1 Pressure Measuring System: A Functional Description 4-43 4.6.2 Air-in-Line Detection . 4.6.3 Malfunction Detection: A Functional Description 4.7 MODES OF DELIVERY (DIP SWITCH OPTIONS) 4.7.1 Changing Modes of Delivery 5.0 MAINTENANCE AND FUNCTIONAL DEMONSTRATION ....... 5-3 5.1 MAINTENANCE ...... : 5-3 5.1.1 Cleaning the Exterior . 5-3 5.1.2. Sanitizing the infuser . 5-5 5.1.3. Inspecting the Infuser . 5-5 5.1.4 Battery Maintenance .... Overviow . 6. ++ Depth of Discharge Recharging 5.2 FUNCTIONAL DEMONSTRATION . Power System Performance . Software Revision Level Chock Screen Display Integrity . LCD Verification . . Touchswitch Operation . Delivery Accuracy Nurse-Call Alarm Test . Bubble Sensor Alarm: Air-in-Line Detection Pressure Sensor Operation Battery Charger Circuit Battery Life (Optional) . Leakage Current to Metal Enclosure 5.2.13 Grounding Continuity Verification ... 6.0 TROUBLESHOOTING 6.1 TROUBLESHOOTING GUIDE 6.2 PART REPLACEMENT INSTRUCTIONS . 6.2.1 Battery Cover and Battery Pack Removal 6.2.2 AC-Line Power Cord and Fuses Removal . 6.2.3 Minipole Removal 5-10 5-10 5-11 5-11 5-11 5-12 6-3 6-4 6 6-12 6-13 6-14 7.0 WARRANTY aerate 7-3 8.0 SCHEMATICS AND PARTS LISTS. 8.1 ABBREVIATIONS AND SYMBOLS 8-3 8.1.1 Letter Symbols ..... i 8-3 8.1.2. Parts Lists Abbreviations . 83 8.2 RECOMMENDED SPARE PARTS . 84 8.3 DRAWING LIST . a4 INDEX ........ bs v 430-03426-002 (BLANK PAGE) 1.0 INTRODUCTION 430-03426-002 rat ABBOTT LIFECARE 5000 INFUSION SYSTEM Introduction (BLANK PAGE) ara 430-02426-002 1.0_ INTRODUCTION ‘The LifeCare 5000 Infusion System is an advanced, general purpose Infuser designed for the accurate volumetric infusion of parenteral and enteral fuids, blood products, and drugs. Clinical applications for the product exist in a wide range of areas, including’ * Icurccu © Emergency © Mobile Intensive Care © Pediatrics © OB/GYN © Neonatology © Cardiac Cath Lab © Post Op/Recovery © OR/Anesthesia © Oncology © Burn Unit © Home Care '* General Floor For detailed information on Infuser features and uses, refer to the System Operating Manual 1.1_ ABOUT THIS MANUAL. 430-03426-002 This Technical Service Manual contains information needed to perform testing, servicing, and troubleshooting. ‘The manual is organized into eight sections: Section 1.0 ~ Introduction Section 2.0 ~ Specifications Section 3.0 - System Operating Manual Section 4.0 - Theory Of Operation Section 5.0 - Maintenance and Functional Demonstration Section 6.0 - Troubleshooting Section 7.0 - Warranty Section 8.0 - Schematics and Pants Lists WARNING: SERVICE INSTRUCTIONS ARE FOR USE ONLY BY QUALIFIED ABBOTT-TRAINED BIOMEDICAL ENGINEERS (BMEs), BIOMED-ELECTRONICS TECHNICIANS (BMETs), OR ABBOTT FIELD SERVICE PERSONNEL. TO AVOID PERSONAL INJURY OR INSTRUMENT DAMAGE, DO NOT PERFORM ANY REPAIR OR CORRECTIVE ACTION UNLESS YOU ARE FULLY TRAINED AND AUTHORIZED TO DO SO. USER-SERVICEABLE PARTS ARE LIMITED TO THE BATTERY, FUSES, AND LINE CORD. THERE ARE NO USER-SERVICEABLE COMPONENTS INTERNAL TO THIS DEVICE. ABBOTT LIFECARE 5000 INFUSION SYSTEM Introduction 1,2_USER QUALIFICATION. ‘The LifeCare 5000 Infusion System is for use at the direction or under the supervision of licensed physicians, or by licensed or certified health care professionals who are trained in the use of the Infuser and the administration of parenteral or enteral fluids or drugs. 1.3_WARNINGS, CAUTIONS, AND NOTES ‘Throughout this Technical Service Manual, three types of alert messages are used, as described below. WARNING: A WARNING CONTAINS SPECIAL SAFETY EMPHASIS AND MUST BE OBSERVED AT ALL TIMES. FAILURE TO OBSERVE A WARNING IS POTENTIALLY LIFE-THREATENING. CAUTION is readily visible in bold print and front of a procedure or statement. It contains information that could prevent irreversible damage or hardware failure. Neglecting to pay attention to a CAUTION may cause serious injury. Note: A Note highlights information that helps explain a concept or procedure. Please pay attention to all warnings, cautions, and notes 2.0 SPECIFICATIONS 430-03426-002, a ABBOTT LIFECARE $000 INFUSION SYSTEM Specifications (BLANK PAGE) aa 430-03426-002, 2.0 SPECIFICATIONS PHYSICAL: Weight: Casing: ELECTRICAL: Power: Power Cord: Fuses: Battery: Recharge: Self-discharge: Electrical Leakage: ENVIRONMENT: DELIVERY RATE RANGE: ‘Micro Mode: Macro Mode: 430-03426-002 Approximately 18 x 23 x 23 cm (7x9 x9 in), excluding pole clamp Protrusion and power cord storage. Approximately 6.0 kg (13 Ib). with battery. High-impact plastic. US: 110-120 VAC, 50-60 Hz, 30 W Japan: 100 VAC, 50-60 Hz, 30 W International: 220-240 VAC, 50-60 Hz, 25 VA US and Japan: Hospital-grade AC cord. 8 ft long, with transparent plug and retainer plate. International: International Electrotechnical Commission, IEC, 601-1 approved cordset. 25£0.5 m. US: 110-120 VAC, 0.4 A, 250 V, Slow-Blowing, Japan: 100 V, $00 mA, 250 V, Time-Lag. International: 220-240 V, 0.16 A, 250 V, Time-Lag. One sealed, lead-acid, rechargeable 8 V battery, internal to device. Accessible for ease of field replacement, with color-coded leads and polarized connector. Battery life (new batteries, full charge, at 20° C): Approximately 6 hours at 125 mL/hr. Battery on recharge anytime unit is plugged in. Recharge rate: to 80% of prior charge in 24 hours while operating at a delivery rate of 125 mL/hr or lower. (Refer to Section $.1.4, Battery Maintenance.) 30% of charge retained for at least 1 month when unit is neither plugged in nor operating. Risk current limits meet AAMI/ANSI SCL. (ungrounded) 12/78 standard. 10-40° C, 10%-90% humidity. 0.1 to 99.9 mL/hr (in 0.1-mL increments) 1 to 999 mL/hr (in 1-mL increments) 23 ABBOTT LIFECARE $000 INFUSION SYSTEM Specifications DOSE LIMIT RANGE: Micro Mode: Macro Mode: OPERATING PRESSURE: SECONDARY DOSES: OCCLUSION ALARM: Distal: Proximal: AIR-IN-LINE ALARM: Distal: Proximal: NURSE-CALL SYSTEM Note: While using the concurrent delivery feature, neither the primary rate nor the secondary rate can be less than 1 mL/hr. The total of the primary rate plus the secondary rate cannot exceed 800 mL/hr in Macro mode or 100 mL/hr in Micro mode. 0.1 wo 999 mL (in 0.1-mL increments) 1 to 9999 mL (je 1-mL increments) -2 to 8 psig (-14 to 56 kPa) For dual channel delivery. a single dose of a secondary fluid may be administered. For multidose delivery, 1 10 24 doses of a secondary fluid may be administered at intervals from 15 minutes to 24 hours. ‘The maximum pressure is user-selectable from 1 to 8 psig (7 to 56 kPa), via the front panel touchswitches. ‘The DISTAL OCCLUSION alarm sounds within ‘two pumping cycles after the distal set tubing OF set outlet fitting becomes occluded. ‘The PROXIMAL OCCLUSION alarm sounds within five pumping cycles if the tubing proximal to the cassette becomes occluded. ‘The distal (“bubble”) AIR-IN-LINE alarm will sound if a bubble 100 wL or larger passes the distal air-in-line sensors. (The alarm may acwually sound at detection of a bubble as small a5 50 BL.) ‘The proximal (“empty”) AIR-IN-LINE alarm will sound if a bubble approximately 600 uL or larger passes through the proximal air-in-line sensors. NURSE-CALL alarm is factory set for normally ‘open (NO). Note: Contact the Technical Services Center to make an internal adjustment to change the Infuser from a normally-open (NO) to normally-closed (NC) system. 430-03426-002 3.0 SYSTEM OPERATING MANUAL 430-03426-002, Bt ABBOTT LIFECARE 5000 INFUSION SYSTEM ‘System Operating Manual (BLANK PAGE) 3.0 SYSTEM OPERATING MANUAL ‘A copy of the LifeCare 5000 Infusion System Operating Manual is included with every device. Please insert a copy here for ‘convenient reference. If an operating manual is not available, contact the Technical Services Center at 1-800-ABBOTT-3, 430-03426-002 33 ABBOTT LIFECARE S000 INFUSION SYSTEM System Operating Manual (BLANK PAGE) 4.0 THEORY OF OPERATION 430-03426-002 4-1 ABBOTT LIFECARE 5000 INFUSION SYSTEM ‘Theory of Operation (BLANK PAGE) 4.0 THEORY OF OPERATION ‘This section describes the theory of operation of the LifeCare 5000 Infusion System. Included are descriptions of the five status conditions of the Infuser, and details on how major assemblies and electronic circuits work. ‘The organization of this section conforms with the subsystems of the Infuser. Related drawings in Section 8.0, Schematics and Parts Lists, are referenced. 4.1_OPERATIONAL OVERVIEW. 430-03426-002 ‘The LifeCare 5000 Infusion System is a microprocessor-based, electro-mechanical fluid delivery system. ‘The Infuser is internally configured by a dip switch, which sets the Infuser for either a “micro” (0.1 to 99.9 mL/hr) or “macro” (1 to 999 mL/hr) delivery rate. It also has 24-hour programmable delivery for primary or secondary delivery. This same dip switch is used to set the unit to accept only single dose or multiple dose instructions. The user programs and controls Infuser operation through touchswitches on the front panel. Integral to the system is a cassette that provides a precise flow rate. The cassette also has air-in-line detection and ressure-sensing capabilities. See Figure 4-1 for an overall block diagram. 43 ABBOTT LIFECARE 5000 INFUSION SYSTEM Theory of Operation ‘MOTORS. PLUNGER 0. VALVE ‘SENSORS “OPTICAL MECHANISM SOSITION. ULTRASONIC "AIRSIN-LINE NURSE-CALL Figure 4-1, Block Diagram of the LifeCare 5000 Infusion System 4.2_INFUSER STATUS CONDITIONS. 4.2.1 OFF ‘The Infuser has five status conditions: © OFF BATTERY OPERATION © SELF-TEST © SYSTEM MALFUNCTION © SET-UP/OPERATING ‘These are entered or exited automatically as part of the normal ion of the pump. Following is a complete description of these 4.2.2 SELF-TEST 430-03426-002 ‘The OFF status is entered whenever the cassette door is opened or the door is closed with no cassette in place. In the OFF status: © Infuser does not operate. © LCD and LED screen displays, are extinguished. The power source indicator (green symbol ing AC power, red symbol indicating battery power) will remain illuminated. © Valve and plunger motors of the pumping mechanism are returned to home position. “Home” means: ~ Plunger fully retracted. = Inlet valve open and outlet valve closed. = Primary fluid inlet valve open and secondary fluid inlet valve closed, © Nurse-call alarm circuit is disabled. © Under normal conditions, critical and set-up data are retained in memory for 4 hours. The user-selected Occlusion Pressure Limit and the Alarm History are retained unless the battery discharges or is replaced. SELF-TEST is invoked whenever the cassette is installed property in the cassette receptacle and the cassette door is closed. In the SELF-TEST status, the Infuser: © Initializes all data except alarm history data (and the user-selected Occlusion Pressure Limit setting if the data retention interval of 4 hours has been exceeded). Tess RAM and ROM © Checks failure monitor circuit status. 4-5 ABBOTT LIFECARE 5000 INFUSION SYSTEM ‘Theory of Operation ‘© Tests LED and LCD screen displays. © Tests the audible alarm. © Checks critical data integrity. © Performs a cassette pressure check. If any of the self-tests fail, the LifeCare $000 Infusion System enters the SYSTEM MALFUNCTION status. When all tests prove successful, the LCD screen indicates “SELF TEST: OK". 4.2.3 SET-UP/OPERATING. With a successful self-test, the Infuser enters the ‘SET-UP/OPERATING status While in the SET-UP/OPERATING status, the touchswitches become active and the main program software Services the 10 ms and other timers. © Services the watchdog monitor. ‘© Updates the 1/0 fag information, © Services the audio processor. ‘© Monitors the cassette sensor. ‘© Determines if dose limit is exceeded. © Monitors the system for existing alarm conditions and generates the audible alarm. © Activates the three motors for pumping operation. © Services the keyboard. © Services the message and numeric displays. ‘© Checks monitor rate versus selected rate. © Services the nurse-call relay. © Services the routine rolling data. ‘© Checks proper microprocessor operation. © Performs RAM memory test, ‘© Performs the ROM checksum test © Monitors accumulated volume data. Exit from the SET-UP/OPERATING status occurs automatically by ‘opening the cassette door, which switches the Infuser into the OFF ‘Set-Up/Operating Activity States 430-03426-002 status. It is also exited automatically after a system failure, or upon detection of a discharged battery. When the Infuser is in the SET-UP/OPERATING status, it will be in one of the three activity states described below. 1) RESET RESET i the first state entered in the SET-UP/OPERATING status, following a successful self-test. The Infuser can also be switched to the RESET state by pressing the RESET touchswitch In the RESET state: © The Infusion pumping mechanism is inactive and the plunger retracts from the cassette into home position. © The LCD message panel prompts the user to enter therapy settings by responding to @ sequence of menus. When the Infuser set-up (see System Operating Manual) is complete, the following message will appear: SETTING COMPLETE PRESS START ‘OR REVIEW © The audible alarm beeps once per minute if there is no touchswitch activity © The cassette door can be opened without producing an audible alarm. © If the RESET state exceeds 5 minutes, the Infuser enters into the alarm state and sounds the audible alarm. © All alarms are prevented, except the S-minute RESET state, CHECK SET and MALFUNCTION alarms. ‘© The user can change previous settings or review current settings and delivery mode. 2) OPERATING ‘The OPERATING state is the normal pumping state during which the Infuser operates according to user-selected parameters. The OPERATING state can only be entered from the RESET state or the SET-UP state. In the OPERATING state: © The Infusion pumping mechanism drives the cassette at the delivery rate set by the end-user. © The user-set delivery rate and total volume are continuously displayed. 47 ABBOTT LIFECARE $000 INFUSION SYSTEM © All front panel touchswitch controls are inhibited, except the REVIEW/CHANGE, RESET and SILENCE keys and the titration function. © All alarm circuits are active. Cassette Leak Tests (See Figure 4-10, page 4-40) After the START touchswitch is pressed, the Infuser performs two ‘major cassette leak tests, the I/O valve check and the piggyback valves check. The Infuser performs the 1/0 test first, and if that is successful it performs the piggyback test. When the I/O check is begun, both the inlet and outlet valves are closed. The plunger is then used to pressurize the pumping chamber. ‘A pressurized hold time follows, which varies in length depending on the delivery rate. After the hold time, the outlet valve opens, the inlet valve remains closed and a pressure spike occurs. If the spike is of insufficient amplitude, the test is repeated. If again the spike is of sufficient amplitude, a CHECK SET alarm is sounded. If the pump passes the test, the remainder of the stroke is delivered and then the piggyback test is performed. Piggyback valves are checked after the first intake cycle. Both Piggyback valves are closed, the inlet valve is opened, and the outlet valve is closed. If no air is detected, a pressurized test is performed. If air is detected, an air test is performed. Both tests determine if there is a leak in the Piggyback valves. ‘The pressure test is similar to the 1/O test. Both piggyback valves are closed, the outlet valve is closed and the inlet valve is opened. The plunger is used to pressurize the pumping chamber and the pressure sensor is used to perform the leak test. After the pressurized hold time, the outlet valve opens, the inlet valve closes, and a pressure spike occurs. If the spike is of insufficient amplitude, the test is repeated. If again the spike is of insufficient amplitude, a CHECK SET alarm is sounded. If the pump passes the test, the pump begins normal cycle operation, ‘The pump uses the proximal air detector to perform the piggyback valve leak test. For the pump to perform the test. fluid must be detected by an air sensor. If it does not detect fluid, the unit will perform four more cycles, looking for fluid on each cycle. On the fifth cycle, a CHECK SET alarm will sound if it doesn’t detect fluid. If it does detect fluid, the piggyback valves close, the iniet valve opens, and the outlet valve closes. The plunger pressurizes the pumping chamber. A pressurized hold time follows. Pump software monitors signals indicating a transition in the proximal air sensor reading. If a transition is detected, the pump waits for the next intake and repeats the test. If it fails a second time, the pump sounds a CHECK SET alarm, If the test is successful, the pump begins normal cycle operation. 430-03626-002 3) ALARM ‘The ALARM state is entered when the Infuser detects an alarm condition. Exit from this state can be accomplished only by pressing the RESET touchswitch or opening the cassette door. In the ALARM state: ‘© The Infusion pumping mechanism either drives the cassette at the KVO ("Keep Vein Open”) rate or it stops, depending on the alarm type (see Table 4-1). © The LCD screen flashes either an alarm message or a delivery rate message by indicating either the number representing the KVO rate or all zeros, depending on the alarm type (see Table 4-1). © The nurse-call ci active) also signals that an alarm condition exists for all alarms except for the POWER, FAILURE alarm. © The audible alarm sounds. © The SILENCE touchswitch is activated, if the audible alarm can be silenced. 49 ABBOTT LIFECARE 5000 INFUSION SYSTEM ‘Theory of Operation ALARM MESSAGE OCCLUSION, PROXIMAL ‘DELIVERY RATE AFTER ALARM Table 4-1, Infuser Responses to Alarms Stopped Message “AAT OCCLUSION, DISTAL Stopped Message “AAT PROXIMAL = ae AIR-IN-LINE rea Messags DISTAL 7 Tees rae AIR-IN-LINE ee Be CHECK SET Stopped Message “AAT LOW BATTERY Unchanged Message “AAT WHILE PUMPING! DEAD BATTERY Stopped Message oAAT DOSE END vo Message “AAT POWER FAILURE Stopped None Continuous MALFUNCTION ‘Stopped ‘Message “AAT pooner Stopped Message “AAT ‘=A A” is a combination of short-long tones in Morse Code “A A” format, repeated ‘every 5 seconds. 4.2.4 BATTERY OPERATION Intuser Battery Operating Sequence When the Infuser operates on battery power, the battery voltage is continuously monitored by the processor to alert the operator of the battery condition and to protect the battery from damaging over-discharge. ‘The following sequence occurs when the Infuser is operating at a Tate_of 125 mL/hr with a new, fully charged battery, a) The Infuser is operating on battery power as indicated by the red LED backlit battery symbol on the front panel. b) Approximately 6 hours after battery operation began at 125 mL/hr the message “LOW BATTERY™ appears on the LCD sereen alternating with the normal messages. An 4-10 4630-03426-002 Battery Operation Comments 430-03426-002 intermittent audible tone is also sounded. The Infuser continues pumping. The LOW BATTERY alarm stops when the Infuser is connected to line power, although the battery is still in a discharged state. ©) Approximately 30 minutes after the “LOW BATTERY” message appears the message “STOPPED - DEAD BATTERY” will appear continuously on the LCD screen and an audible tone will sound. In addition, the following will occur: © The Infuser will stop pumping. © The plunger will retract. © The piggyback valve will be placed in primary. © The outlet valve will be closed. © The inlet valve will be opened. © The LCD backlight will be turned off. ‘The STOPPED - DEAD BATTERY alarm stops when the Infuser is connected to line power, but the battery is still in a discharged state. 4) Approximately 10 minutes after the “STOPPED ~ DEAD BATTERY” message appears, the LCD screen will go blank and 4 continuous tone will sound. Infuser eritical data in memory will be lost. This state is called “Hardware Shutdown”. The tone will stop if one of the following happens: ‘© The Infuser door is opened. ‘© The battery completely discharges (this may take days).. © The Infuser is connected to line power. ‘The Infuser was not designed to run on battery as @ normal operating mode. Minimize the time the pump is run on battery power and recharge immediately. In battery operation, the following comments apply: © The Infuser was designed to run on batteries on an exception basis such as: power failure, inadvertent pull out of line cord plug, short periods of patient movement. The Infuser battery system was designed under the assumption that the Infuser is usually plugged into AC power so that batteries are always fully charged, @ The sealed lead-acid batteries used in the Infuser can be damaged by misuse. The main cause of damage is leaving the battery in a less than fully-charged state for a period of time. Battery damage can occur in a matter of hours. This damage will appear as a permanent loss of battery capacity. The amount of lost capacity depends on the degree of discharge, the storage temperature, and the length of storage time in a discharged state If the Infuser is operated with battery power until the “LOW BATTERY” message appears there is a danger of permanently att ABBOTT LIFECARE 5000 INFUSION SYSTEM Theory of Operation damaging the battery. Plug in immediately to minimize the risk of battery damage. (© The battery has a certain cycle life. The battery will degrade quickly if i is repeatedly cycled from charged to a deep discharged state. It will last a long time if itis only lightly discharged and quickly charged to full capacity. © Charging for 24 hours restores the battery to 80% of its previous capacity. To fully charge the battery, 72 hours of charge time is required. 4.2.5 SYSTEM MALFUNCTION. CORE FAILURE State PERIPHERAL FAILURE State ‘The SYSTEM MALFUNCTION status is entered whenever the Infusion pumping mechanism detects a malfunction. There are two failure states that occur in the SYSTEM MALFUNCTION status, as described below. A CORE FAILURE state occurs when: (© The failure monitor detects a permanent or long-duration failure in the core circuitry. During a CORE FAILURE state: ‘© The Infusion pumping mechanism stops. © An alarm sounds a continuous tone. © The nurse-call circuit alarm is activated. © The syster-prompting function is inhibited. A PERIPHERAL FAILURE state occurs when the following is detected: ¢ A malfunction of the failure monitor circuit. ‘¢A mechanical malfunction. A malfunction in the noneritical electric circuitry. © A short-duration, nonpermanent failure of the memory. ‘© Any control override by the failure monitor circuit During # PERIPHERAL FAILURE state: ‘© The Infusion pumping mechanism stops. ‘© The LCD screen flashes “MALFUNCTION” and one of the number codes shown in Table 4-2. © An audible alarm sounds. ao 430-01426-002 (© The nurse-call circuit alarm is activated. Exit from either FAILURE state is accomplished in only two ways: 1. By opening the cassette door. 2. By discharge of the battery. Note: If the alarm is not silenced by opening the cassette door, remove the battery. 4.3 DATA RETENTION 4.3.1 Critical Data Retention 430-03426-002 Critical data is automatically held in memory by the pump for 4 hours after it has entered the OFF status. “Critical data” includes data required to define the status condition, activity state, state of dose function, volume delivered, delivery rate, dose limit, dose delivered. The memory hold time is restored by returning the pump to the SET-UP/OPERATING status. Critical data is lost when: ‘© Four hours elapse after the pump is shut off. ‘© The battery is completely discharged or disconnected. © The SYSTEM MALFUNCTION status is entered. ‘A user-selected Occlusion Pressure Limit setting is retained in memory unless the battery discharges or is disconnected, ‘Once critical data has been lost, the Infuser reverts to default values when it returns to the SET-UP/OPERATING status. 4-13 ABBOTT LIFECARE 5000 INFUSION SYSTEM Theory of Oper 4.3.2_Alarm History Data Alarm history data is a rolling history of alarms and malfunctions. It appears on the LCD screen by twice pressing the REVIEW/CHANGE touchswitch during the first 3 to 5-second time interval after the SELF-TEST:OK screen is displayed shortly after closing the door. The Alarm History Data screen shows 15 alarms and/or malfunction codes, with the most recent appearing at the lower right-hand position. Alarm history data is retained in memory until the battery runs out of charge or the battery is replaced. ‘Table 4-2 lists all the alarm and malfunction codes. See Table 6-1 to find the appropriate user response to an alarm. Table 4-2._Alarm and Malfunction Cod ‘Alarms or Distal line occluded. 03 Primary proximal line occluded. 04 Secondary proximal line occluded. 05 Pressure out of range. 06 Air-in-line (detected by proximal sensor). 07 ‘Air-in-line (detected by distal sensor). 08 Backpriming required. Pump stopped. iL RESET longer than 5 minutes. 2 Primary dose end/KVO. B Casseite leak (1/0 check). 14 Piggyback valve leak (spike amplitude). 15 Piggyback valve leak (detected by air sensor) 16 Piggyback valve leak (unable to perform test even after five tries) 7 Low battery; system still pumping." 18 Discharged battery; system no longer pumping. 19 Door opened while Infuser is pumping. Core Failures 20 STACK runaway error. 24 Critical data corrupted. 2 Watchdog frequency too low. 23 ‘Watchdog frequency too high. 24 Watchdog finds processor failure. 25 Watchdog does not reset processor. 26 Processor internal malfunction. 27 Mlegal instruction trap. 28 RAM check error. 29 Low ROM checksum error. 30 High ROM checksum error. 1 ROM revision number does not match. Display Failures 41 LCD display read/write failure. 42 LCD display RAM failure. 43 LED display failure (numeric digit driver failed). 4a Audible alarm failure. 45 Keyboard switch closed longer than two minutes and 40 seconds. + This code will not appear in the Alarm History. aaa 4x9-11426-002 Table 4-2. Alarm and Malfunction Codes - continued Infusion Pumping Mechanism Failures Plunger motor does not synchronize. VO valve motor does not synchronize. Piggyback motor does not synchronize. Plunger motor sticks or slips. VO valve motor sticks or slips. Piggyback motor sticks or sips. Verity motor failed. Internal timers unsynchronized Motor not running; software motor watchdog confused. Miscellaneous Software not executed in 10 ms period. Pressure sensor amplifiers saturated. AID converter failure (0 V, 2.5 V and $ V tests). Urasound transmitter (or receiver) failure. Overvoltage protection failure. Distal air sensor failed ongoing check. Proximal air sensor failed ongoing check. Proximal air sensor is OFF when it should be ON. Piggyback safety spring is broken (also I/O chip may be bad). 4.4 ELECTRONICS: An Overview The following pages contain discussions on the Printed Wire Assembly (PWA) electronic circuits in the LifeCare 5000 Infusion System. Each PWA circuit is described individually and follows a logical course from input to output. Each description also includes: © An overall description of the circuit board design function. © A block diagram showing each of the functional operations and/or subsystems as well as associated electronic circuits, where applicable. © A component level discussion, with reference designations, of every electrical circuit function on the PWA. © An explanation of terms and definitions, where needed. 4.4.1_MAIN PWA: A FUNCTIONAL DESCRIPTION (SEE FIGURE 8-2) ‘The Main PWA contains the central controlling system for the Infuser. It performs several functions, including: © Controlling the microprocessor unit (MPU) and clock. © Providing the second clock source. © Providing Erasable Programmable Read-Only Memory (EPROM) protection 430-03426-002 4-15 ABBOTT LIFECARE $000 INFUSION SYSTEM ‘Theory of Ope: ‘© Providing Random Access Memory (RAM) protection, © Providing logic (for the selection of various ‘memory functions). © Analog-to-digital conversion. © Supply voltage conversion. For each of these functions, a discussion follows. See Figure 4-2 for a functional block diagram of the Main PWA. eager enacts nos ‘COUNTER: DIVIDER, Jad Figure 4-2. Functional Block Diagram of the Main PWA 430-03426-002 417 ABBOTT LIFECARE $000 INFUSION SYSTEM Theory of Oper ‘Microprocessor Unit (MPU) and Clock Second Clock Source EPROM, RAM, and Memory Protection Custom Discrete Logie Ic ‘The 40-pin Hitachi HD63B03R CMOS microprocessor, U8, on the Main PWA provides the central processing unit (CPU). This CPU contains 128 bytes of RAM, the serial communication interface (SCI), the parallel 1/0 ports, and a multifunction timer. It is address and data bus-compatible with the Motorola MC6800 family of microprocessors. In addition, it can be expanded to 64K bytes. ‘The microprocessor clock consists of the 8 MHz crystal Y2 and capacitors C10 and C11. This clock is divided internally by four to give a 2 MHz system cycle frequency. The second clock source contains the 455 kHz resonator Y1, the inverter U2, and the capacitors C8 and C9. This clock performs: © Watchdog pulse source. © LED refresh interrupt timer. © Baud rate generator. ‘The EPROMs are 28-pin 27C256 integrated circuits (ICs) that seat into sockets U3 and U4. They contain 48K bytes of usable pro- ‘gram capacity. It is protected and mapped into the address space from hexidecimal 4000 to hexidecimal FFFF. “The RAM is a 24-pin IC with 2K bytes of program capacity. This IC seats into the IC socket US. To operate, it obtains power from its own +5 V nominal power supply, VMEM. VMEM remains Active at approximately 2.3 V providing an appropriate AC receptacle or battery is available. In this way, all critical data is protected in a nonvolatile retention manner for use by service personnel. Memory is protected by the U6 NAND gate (74HC00) during the transition to VMEM standby power supply. The RAMSEL signal generated by the U9 custom IC is ANDed with REGON and the inverted output is used to select the US RAM (HM6116) only when +5 V is available. REGON is provided by the power supply and immediately goes inactive when the Infuser is turned off. RAMSEL is forced low by a system RESET and during power-up when the door is closed with a cassette properly installed. Thus the RAM is deselected at times when incorrect data might otherwise be written to it. ‘The custom IC, U9, is a HCMOS 84-pin gate array that provides: Address decoding. Bus interfacing. Timing control. LED/LCD interfacing. Power-up/system reset control. 41k 430-03426-002, ‘Analog-to-Dightal Analog-to-digital (A/D) conversion is provided by IC ADCO834, Conversion U7. Itis an 8-bit A/D converter with a serial 1/0 and a selection of 4-channel multiplexed inputs. The A/D signal from U7 then provides the microprocessor with the means to generate all the interfacing signals required for operation of the Infuser. The microprocessor also transforms the A/D signal from U7 into, for example, pressure measurements, LED segment test current and battery voltages. ‘Supply Voltage ‘The voltage converter ICL7660, U1, performs the conversion from Conversion Positive (+5 V) to negative (-5 V). This conversion is required for adjusting the LCD viewing angle via potentiometer R1. 4.4.2 VO PWA: A FUNCTIONAL DESCRIPTION (SEE FIGURE 8-3) The 1/0 PWA contains the electronics that control the input and the ‘output of the Infuser System. It performs several functions, including: © Logie and control on a custom IC. © Circuitry for motor drives © Nurse-call relay control © Operation mode selection. For each of these functions, a discussion follows. See Figure 4-3 for a functional block diagram of the 1/0 PWA. ——— 7 RESET/INIT) rowen conto} —t WAKEUP, TO POWER SUPPLY PWA pace! 1 ALARM? PIEZO ALARM nonsecttt tee RURGE-CALL RECT MOTOR DRIVER PLUNGER, ‘MOTOR MOTOR DRIVER VALVE J MOTOR PIGGYBACK MOTOR Figure 4-3. Functional Block Diagram of the VO PWA 1430-03426-002 4-19 ABBOTT LIFECARE 5000 INFUSION SYSTEM ‘Theory of Operation Logic and Controt ona Custom IC Clreuttry tor Motor Drives ‘Nurse-Call Relay Control Delivery Mode Selection ‘The 84-pin HCMOS custom IC, U3, includes all transmit and receive buffers, various input buffers and output latches, timers/counters, and sequential logic circuitry. It contains: © Bus interface. © Watchdog monitor. © Timing control. © Sensor interface. © Key interface. ‘© Motor contro! latches. ‘© Communication port interface. N-channel MOSFET transistors Q1 through Q12 comprise the driver circuits for plunger motor, valve motor, and piggyback motor operation. ‘These transistors sink current from the appropriate step motor winding when turned on in the proper sequence. Gate drive for Q1 through 2 is provided by resistor networks RN2 and RN3 connected to the open drain outputs of the U9 custom IC (pins 2 through 7, pins 8 through 11, pin 82 and pin 83). Transistor Q15 controls the ON/OFF state of the nurse-call relay Ki. Socket JP3 is a jumper for the selection of normally-open versus normally-closed connection to the NURSE-CALL alarm. Nurse-call relay contacts are made available via J23 at pins 1 and 3, Switch SW2 assigns the delivery mode of the Infuser. Refer to Figure 4-11 for the preset dip switch options. 4.4.3, POWER SUPPLY PWA: A FUNCTIONAL DESCRIPTION (SEE FIGURE 8-4) ‘The LifeCare $000 Infusion System obtains power from the hospital-grade AC receptacle or from the internal & V battery pack should AC-line power fail or become unavailable. It is the Power ‘Supply PWA that forms the power circuitry for AC-line or battery ‘operation of the Infuser. In addition, this PWA performs several other functions, including ‘© AC-line and battery power indicator. ‘© Power control logic and motor power supply regulation. © Audible alarm self-test. Unreguteted DC Power Supply 430-03426-002 © Battery charging. © Discharged battery detection. For each of these functions, a discussion follows. See Figure 4-4 for a functional block diagram of the Power Supply PWA. ‘As shown in Figure 4-4, the unregulated supply is composed of the power transformer T1 in conjunction with the rectifier and fier. ‘The AC-line voltage is applied to T1 via the power cord and fuses F1 and F2 located on the back panel (see Figure 8-1, System Interconnect Schematic). The secondary is center-tapped for full-wave rectification by diodes CR7 and CR8. Under no-load conditions the secondary can deliver 22 V RMS. Capacitor C11 filters ripple voltage that appears between +RDC and -RDC (Genoting positive and negative raw direct current, respectively) 4-21 ABBOTT LIFECARE 5000 INFUSION SYSTEM ‘Theory of Operation os SOWER RECEPTACLE] TRANSFORMER OVERVOLTAGE, VERVOLTAGE | ovpvMorF SENAN ALMFLG, an 430-03426-002 AC-Hine and Battery Power Indicators Power Control Logic and Motor Power Supply Regulation 430-03426-002 Operating the Infuser on battery power causes the green LED (AC-line power indicator on the Display PWA) to extinguish and the red LED (battery power indicator) to light up. ‘The line/battery indicator circuit is composed of transistor Q17, diode CRI1, and resistors R10, R21, R23. BPLEDA signal at P4 pin 37 sources current—via the parallel combination of R10 and R21—to the anode of the battery power LED indicator on the Display PWA. This action occurs when Q17 1s OFF because diode CRi0 is reverse-biased, thus removing the =RDC signal supply to the source of Q17. When operating on AC-line power, 017 is turned ON and shunts current around the red LED via diode CRi1 to tum off the battery power LED indicator. The +RDC supply sources current through resistor R23 and LPLEDA at P4 pin 38 to the anode of the AC-power green LED. The cathode of this LED returns to -RDC via P4 pin 40, ‘The power control and power motor supply regulation on the Power Supply PWA consist of: The 5 V regulator. ‘The 2.3 V memory backup power supply (VMEM regulator). ‘The motor power supply (motor power regulator). ‘The overvoltage protector, ‘The beeper backup capacitor. ‘The audibie alarm control. eeccee ‘The Power Control By installing a cassette and closing the door, the cassette switch on the Sensor PWA is actuated. Whereupon, SWRDC at pin 1 goes high. Hence a positive pulse is placed on the base of the NPN’ transistor Q9 via C19, RNT (1,2) and RN10 (4,5) to tum on Q9. The base of PNP transistor Q18 is then pulled low by Q9 so that the collector of Q18 brings the REGON line (P4 pin 32) high: REGON enables both the +5 V and motor regulators. This line also reports to the I/O PWA and Main PWA that drive the motor regulators. The custom I/O chip latches this condition by activating the WAKEUP input (P4 pin 6) to source the base current of Q9 via RN10 (3,4) and keeping REGON high Diode CR12 allows C19 to discharge when the cassette switch is deactivated by removal of the cassette from the door. ‘The SV Regulator For the 5.0 V power supply, the volage reference diode U2 adjusts Precisely to +2.5 V by means of R2 and connects to the Roninverting input at U3A via R10 and the resistor network R7 4-23 ABBOTT LIFECARE $000 INFUSION SYSTEM Theory of Operation (9,10). U2 also adjusts the same 2.5 V reference for the 6.5 V power supply and the A/D converter. The REGON line through the resistor network RN7 (7,8) provides power for U2. The voltage divider, composed of resistor network RN4 (6,7) and resistor network RN4 (5,6), feeds back one half of the +5/VAN output at P4 pin 27 to the inverting input of op-amp U3. This input is then amplified to drive the base of Qt0. If the +5/VAN output is too low, Q10 will pass sufficient lead ‘current from the base of Q13 (PNP series-pass regulator transistor) to raise the output voltage. This controlling action reverses when the output is too high. In other words, Q10 will draw less load current from the base of Q13 to lower the output voltage and drive the +5/VAN level to acceptable operating voltage limits of the 5 V Power supply. Current limiting is provided by U3B operating as a voltage comparator. The divider networks, composed of resistor networks RN4 (8,9) with RNA (9,10) and resistor networks RN4 (9,11) with RN4 (9,10), provide a 135 mV reference to the inverting input of U3B. Should the load-return current through R6 from P4 pin 25 exceed 1.35 A, the output of U3B will go high to tum on transistor 7 via resistor R11. The collector of Q7 then clamps the noninverting input of U3B to ground, removes the 2.5 V reference, and disables the +5/VAN supply. ‘The YMEM Regulator MEM (P4 pin 19) is the +2.3 V memory-backup supply for RAM US on the Main PWA. When the Infuser is pumping, the REGON line is high and turns on transistor Q14 via the resistor network RN8 (1,8). Q14 then supplies the VMEM line with +5 V through its collector-emitter junction. The Schottky diode CR17 blocks this +5 V from the 2.5 V reference produced by the voltage comparator U6. When the Infuser is not pumping, the REGON line goes low to tum off Q14. This controlling action causes CR17 to be forward-biased by U6. In this manner, U6 via CR17 supplies MEM. ‘The Motor Power Regulator ‘The 46.5 V motor supply is regulated in a similar manner as the +5 V supply. The voltage comparator U2 supplies +2.5 V to the noninverting input of U3C. The divider networks, composed of resistor networks RN3 (3,4), RN3 (4,5), and R9, apply a fraction (0.385) of the MOTPWR output voltage at P4 pin 24 to the inverting input of U3C. 4-24 430-03426-002 430-03426-002 When the MOTPWR line is +6.5 V, U3C will then provide the necessary reference voltage as follows: (0.385)(6.5 V) =2.5.V Any variance from the 2.5 V reference is continuously corrected as UC3 varies the load current through transistor Q6 via Q4. ‘Current limiting is provided by U3D operating as a voltage ‘comparator. The divider networks, comprising resistor networks RN3 (8,9) with RN3 (9,10) and resistor networks RN3 (9,11) with RN3 (9.10), source a 293 mV reference to the inverting input of USD. Should the motor-return current through R4 exceed 2.93 A, the output of U3D will go high to tur on transistor Q12 The collector of Q12 then clamps the noninverting input of U3D to gound, removes the 2.5 V reference, and disables the +6.5 V motor supply. ‘The VMOFF line at P4 pin 4 is a control signal from the 1/0 PWA. Operating under software control, a logical high at P4 pin 4 will turn on Q12 and disable the +6.5 V motor supply the same way as the current limit does it. Note: The OVPVMOFF signal from the over-voltage protector can also disable the motor supply via Q12. ‘The Overvoltage Protector A fauly +5 V power supply could damage the processor on the Main PWA, Therefore, when malfunction of the +5 V supply ‘occurs, the motors of the Infusion pumping mechanism automatically stop. Such stoppage occurs in the following manner: The op-amp USB senses the +5/VAN supply line via the divider network, comprising resistor networks RNS (8,9) and RN9 (7,9) These networks divide the +5V/VAN level by a factor of 0.452 for comparison with the +2.5 V reference from U6. Should the 45/VAN level exceed 5.5 V, eg (2.5 V) + (0.452), the output of USB will go high to activate the OVPVMOFF line (or pull-down signal) via CRIG and RN9 (3,4). This controlling action shuts off the 46.5 V motor supply. Subsequently, the OVPALM signal from the output of USB then triggers the audio alarm indicating an overvoltage situation. Signals OVPREF (P4 pin 16) and OVPTST (P4 pin 13) are available for monitoring and testing by the 1/0 PWA ‘The Beeper Backup Capacitor (“Super-Capacitor”) Should the supply voltage drop to zero due to a complete battery discharge or should a catastrophic failure of the logic circuitry occur while the cassette is installed and the door is closed. the capacitor C3 automatically provides backup energy for several minutes to allow the audible alarm to sound, C3 is charged from the 5 V supply via CRS. Diodes CR3 and CR¢ isolate the charged capacitor unless the cassette switch SW1 or beeper is activated. 4-25 ABBOTT LIFECARE $000 INFUSION SYSTEM ‘Theory of Operation ‘The Audible Alarm Contra} ‘The audible alarm controt consists of a self-contained piezoelectric transducer and built-in oscillator circuit. It emits a sound via the audible alarm beeper when triggered by: © The AUDALM signal (a current path to ground from the beeper) Refer to P4 at pin 3. This signal comes from the 1/0 PWA and {g0es low to turn off transistor Q3 via resistor networks RN1 (5.6) and RN1 (4,5). With the base of Q3 no longer clamped to ground, Q2 will tur on by the SWRDC current through NI (7,8) and then sinks beeper current to sound the alarm. © The OVPALM signal (a current path that energizes Q1). ‘This signal is supplied by the output from USB. It goes high when an overvoltage condition occurs. Q1 will turn on by the current through resistor networks RN1 (1,2) and RNI (2,3) which then sinks beeper current to sound the alarm. ‘© The WDTRAP signal (a current path wired with the OVPALM signal) Refer to P4 at pin 29. This signal comes from the 1/0 PWA When the watchdog circuitry detects a microprocessor malfunction, Q1 then turns on via the resistor network RN1 (2.3) to sink beeper current and sound the alarm. © The -5 V supply from the Main PWA. ‘The audible alarm beeper can also emit a sound with the loss of 5 V line signal via P4 at pin 29. This signal must come from a voltage converter powered from the +5 V supply on the Main PWA. When present (normal condition), the -5 V keeps the depletion-mode transistor JFET Q19 turned off. If the ~5 V is lost due to converter failure, SWRDC current through low resistance via the resistor network RN10 (6,7) will increase the beeper loudness ‘When the -5 V is present, the beeper current from SWRDC is attenuated by the series combination comprised of resistor networks RN10 (6,7) and RN10 (7,8) with resistor R30. Alarm volume is controlled by switch SW1 on the /O PWA in conjunction with transistors QS, Q19, Q21 and associated passive components, In the “high volume” setting, SWDC (P4-1) furnishes beeper current via RN1O (6,7). In the “medium volume” setting, the current is attenuated by RN10 (7,8) and R30 in series with RN1O (6.7). The “low volume” setting is similar to the “medium-volume”, except that a portion of beeper current is shunted by QS, R31 and RN10 (9,10) to lower the volume. ane axn-0426-002 Audible Alarm Self-Test Battery Charging 430-03426-002 Audible alarm operation is tested by comparator US, transistor Q11, and associated passive components. A low ALMFLO signal (P4-7) informs the microprocessor of proper alarm operation. Audible alarm self-test is performed by bringing OVPTST (P4-13) high, turning on Q21 and thereby turning off QS. This controlling action removes the shunt across the beeper during a “low-volume” setting of SW1. With sufficient beeper output thus assured, the AC voltage produced by the beeper transducer is verified. The AC frequencies above 1.5 kHz are extracted by the high-pass filter composed of C2, R7 and Ci, RNi (9,10). Such signals are applied to the noninverting input of USC with CR1 clamping the negative excursion to ~5 V. A reference of +0.1 V is provided by RNS (5,6) and RNS (6,7) at the inverting input of USC. If the output is greater than the reference, the ourput of USC will go high to turn ‘on QI1. The ALMFLG (P4~7) line is then clamped low by Qi1 to indicate normal beeper operation. ‘The battery charger circuit consists of the following: Transistors Q8, Q15, Q16, and Q20. Diodes CR6, CR9, CR26, and CR27. Reference U1, Operational amplifiers U4A and U4B. Associated passive components. ‘Since battery terminal voltage is a function both of its state of charge and temperature, the end-of-charge reference voltage is temperature compensated. Also, a trickle charge current is provided to maintain the battery between normal charge/discharge cycles. ‘The positive battery terminal J17-1 is the common line for the charger, battery, and raw-DC supply. The inverting input of comparator U4A is provided with -2.32 V reference relative to +RDC. This reference derives from U1 via resistors R26 and R29, potentiometer R28 with CR26 and CR27 to lower the charging voltage ~4 mV per degree Centigrade. ‘The battery terminal voltage is sensed via diode CR6 and divider RN2 (1,2) and RN2 (2,3). Thus, the noninverting input of U4A sees |-VBATT - 0.5(CR6 V)/4.2 = 2.32 V relative to +RDC ‘when the battery is fully charged. CR6 disables the charger during battery operation. Current sources Q15, Q16, and RNG (1.2) keep the forward drop of CR6 constant. The output of U4A is high for VBATT less than 9.2 V (2.3 V per cell), turning on FET Q20 via RN2 (8,9). Charging current then flows through CRi0 and 0.1.9 sensing resistor R18 to -RDC ‘The current loop uses U4B to compare the voltage drop across sensing resistor R18 to approximately 0.1 V from the divider RNS (1,2), RN6 (2,3), RN6 (3,4), and R8. Should the load current exceed (0.1V/0.1 9) = 1.0 A, U47 goes high, turning on O8 via 4-27 ABBOTT LIFECARE $000 INFUSION SYSTEM. ‘Theory of Operation Battery Detector RN6 (6,7). Q8 then clamps the noninverting input of U4A to =RDC to send U4-1 low and turn-off Q20. The charger is thus protected against excessive load current. When supplying power, the battery return current path is through the source-to-drain of Q20, RN2 (7,8) and RN2 (8,9) forward bias the gate of Q20 with respect to its drain-causing FET to ‘operate in the inverted mode. Thus, the source and drain of the FET exchange current of about $ mA is supplied through CR9 and R15 when the battery voltage is not low enough to trigger the charger into operation. ‘The sealed lead-acid battery may be damaged if drained to less than about 1.6 V per cell (four cell battery = 6.50 V). This state of discharge is detected by the battery detector on page 2 of the Power Supply schematic (Figure 8-4), This circuit will then terminate battery operation and notify the user of the need for recharging. US-A, diodes CR13-15 and the associated passive components constitute the detector. ‘The REGON line equals the battery voltage minus the approximately 0.06 V drop across Q20's source-drain and the collector-emitter junction of Q18. This voltage is divided by RNB (1,2), RNS (2,3), RNS (3,4) and RNB (4,5) to yield (0.388)(REGON) = (0.388)(6.50-0.06) = 2.5 V at the inverting input of US-A when the battery is discharged. US-A compares this to the 42.5 V reference at its non-inverting input so that its output ‘oes high, signaling a discharged battery. This makes BADBAT (P4=19) active, setting a latch on the custom I/O chip which return a low WAKEUP signal to the Power Control circuit, disabling both the +5 V (logic) and +6.5 V (motor) supplies. CRIB clamps the inverting input of US-A to 5.5 V with a fully charged battery. CR15 clamps the BADBAT line to 5.5 V to be compatible with logic levels on the 1/0 PWA. R22 supplies a positive input bias for U3-A’s inverting input. INITBAT (P4~30) is set high for approximately 50 ms during pump tum-on by R14, C14 and the custom 1/0 chip on the 1/0 PWA. ‘This signal charges C20 through CR14 to avoid false bad battery indication before REGON is able to charge C20 through RNS (1,2). Thereafter, INITBAT goes low and remains that way during ‘operation of the Infuser. 4.4.4 SENSOR PWA: A FUNCTIONAL DESCRIPTION (SEE FIGURE 8-5) ‘The Sensor PWA contains the following: © Optical interrupters to sense the state of the pumping mechanism. © A pressure amplifier for the strain gauge pressure transducer. © An ultrasonic transducer driver for the air-in-line detector and the cassette switch. See Figure 4-5 for a functional block diagram of the Sensor PWA. OPTICAL INTERRUPTERS #2 PIGGYBACK.. VALVE #1 PIGGYBACK VALVE t ' Apt WO VALVE ~ PLUNGER FLAG ON ——————_» ‘TRANSDUCER DRIVER eens t ow | XBUBBLE | |_ paver wer 4 PRESSURE AMPLIFIER, igure 4S. Functional Block Diagram of the Sensor PWA 430-03426-002 429 ABBOTT LIFECARE $000 INFUSION SYSTEM ‘Theory of Operation Optical interrupters Optical interrupters Q3, Q7, Q9, and QB sense the position of the three stepper motors that actuate the valves and plunger. ‘Auached to each motor shaft is an opaque flag. The flag breaks the light path of the interrupter at specific motor positions. ‘Transistor Q4 sinks the lead current of the interrupters when the FLAGON (J6-2) enabling signal is applied to its gate (by means of the microprocessor through the 1/0 PWA), Transducer Driver Airis detected in the cassette at the following locations: © Where fiuid enters the cassette (proximal). © Where fiuid exits the cassette (distal). Operation of the two channels is similar. Ultrasonic piezoelectric transducer pairs (driven by circuitry on the Sensor PWA) will have their signal paths interrupted when air is present in the sensing areas of the cassette. ‘The voltage-controlled oscillator section of the 74HCT4046 (U1-A) phase-locked loop integrated circuit and a single FET (Q1) drive both transmitting transducers via the XEMPTY (J20~5) line. A 5 kHz triangular wave oscillator formed by Op-amp U3-B and an XOR gate inside U1 sweep the VCO output at U1-4 between 4.5 mHz and 6.5 mHz to assure passing through the resonant frequency of the transducers. CT and R2 set the VCO center frequency, and U1-5 is pulled low by the XMIT (J6-13) line from the I/O PWA when the microprocessor enables the bubble detection system. A high on this line shuts off the VCO and holds U1~4 high. The output is coupled via CS and RS to the gate of driver FET QI. R4 and CRI prevent false turn-on of Q1 by discharging C6 when U-4 is held high or when the L1, C4 tank circuits ring. Ringing of the Li, C4 tank allows peak voltages more than twice the +5 V supply to be developed at the XEMPTY (J20-1) output. ‘Sweeping of the VCO is accomplished by XOR U1-B working as an inverting buffer that charges C14 through R16 until the (-) input of U3-B reaches the (+) level established by the divider R17, RIB. R2 together with the divider provides 0.9 V of switching hysteresis for U3-B. When its (-) input reaches the (+) level, U3-7 and U1-2 (the XOR buffer output) go low to discharge C14 through R16 and start another charging cycle. The resulting input to the VCO (U1-9) is a triangular waveform of amplitude 0.9 V ‘centered at 2.5 V. 4-30 430-03426-002 Pressure Amplifier Cassette Switch 430-03426-002, Pressure sensing is accomplished with a four-element strain gauge bridge bonded to a steel leaf spring. Element resistance is 350 0 and the bridge is excited by the +5 V supply When the spring is deflected by force due to pressure within the cassette, the voltage across the bridge output arms will vary by a Rominal 735 microvolts per psi (105 microvolts per kPa). ‘The bridge output goes to the chopper-stabilized amplifier U4 (which has extremely low and temperature independent offset vokage). R19 sets the gain at U4-10 to be 350, and in combination with C10 rolls this off at frequencies above 10 Hz for noise suppression. This yields a sensitivity of 260 mV/psi (37 mV/kPa) at U4-10, which is attenuated by a nominal factor of 0.6 through Rid and RN3 (7,8). U3-A further amplifies and filters this output with a DC gain of 1.5 set by RN1 (7,8) and RN (8,9). The resulting sensitivity at TPI is 195 mV/psi. ‘The system gain adjustment by R14 allows correction for gauge-to-gauge sensitivity variation. RIS is adjusted to balance the bridge offset with R13 seting the range of adjustment. The bridge is balanced for an output of 1.400 V at TPI using a cassette with zero pressure. The PRESSURE (J6-4) output signal is read by the AID converter on the Main PWA. Switch $1 is actuated when the mechanism door is closed with a cassette installed. This controlling action raises the voltage on SWDC (J6-18) line to the level of RAWDC (J6-20). RAWDC varies from minimum of 6.4 V (when operating from a low battery) to about 15 V (when operating from AC-line voltage). ‘SWRDC performs the following two functions: © Enables the main power regulator to start the Infuser from the OFF status. © Is an input to the custom IC on the Main PWA (thereby signaling the processor that a cassette is installed in the receptacle of the door). Transistors QS and Q6 with associated passive components allow the processor to bypass switch $1. Bypass happens under the two. following conditions: © When the door is opened without first pressing the RESET touchswitch. (S1 is shunted in order to allow the audible sound.) © When the processor is performing power-up self-testing. (The shunted switch prevents loss of 45 V power during the watchdog test.) 4-31 ABBOTT LIFECARE 5000 INFUSION SYSTEM Theory of Operation 4.4.5 BUBBLE SENSOR PWA: A FUNCTIONAL DESCRIPTION (SEE FIGURE 8-6) The Bubble Sensor PWA contains: © Piezoelectric transducer transmit/receive pairs (for detecting air in the cassette at the proximal “empty” and distal “bubble” locations, X1 and X2). '® Drive level adjustment potentiometers (R24 and R25) for each channel, © Preamplifiers (Q4 and Q3). ‘© Amplitude modulated (AM) detectors (Q2 and Q1). ‘© Threshold detectors (UI-A and U1-B) and reference network. See Figure 4-6 for a functional block diagram of the Bubble Sensor PWA. 0 430-03426-002, X2: BUBBLE ty BUBBLE 430-03426-002 4-33 ABBOTT LIFECARE 5000 INFUSION SYSTEM ‘Theory of Operation AM Detector ‘Threshold Detector Reference Network With a cassette installed and the door closed, the two sensor bulbs in the cassette fluid path (see Figures 4-9 and 4-10) are straddled by the transducer pairs. When fluid is present, an ultrasonic (approximately 5 mHz) sound wave will pass through it from the transmit crystal to the receive crystal. Air in the path prevents ultrasonic coupling, thus the lack of a cassette or one containing air is detected by means of signal loss at the receive crystal. Because bubble sensing is identical (other than reference level for threshold detection) for proximal and distal lines, only one channel will be described in the following subsections. R24 sets the power Jevel driving the “empty (X1) crystal, allowing ‘correction for variations in transducer pair sensitivity. A swept RF signal (121-1) from the Sensor PWA ensures that the crystal ‘excites at ts resonant frequency for maximum ultrasonic output The receive crystal is AC-coupled via C10 to the common emitter amplifier Q4 to avoid impressing DC voltage across the crystal Such voltage could degrade crystal sensitivity. Resistors Ri8, R22, and R23 bias the collector of Q4 at about 2.6 V for maximum linear swing. R14, R19, and the emitter resistance of Qé set the gain to approximately ~22. ‘The RF output of the preamplifier is amplitude modulated (AM) by the material (fluid or air) in the ultrasonic path. This signal ‘must be converted to a DC level for threshold detection. R13 and R15 bias Q2 on the edge of conduction to rectify the output of Q4 with only a small voltage drop. The 4.7 ms time constant of R9 and C4 holds the peak DC level between RF sweeps for the threshold detector input. R24 and R25 are adjusted with a water- filled cassette installed in the door to give 1.5 VDC at this point in both channels. These values are established during self-test. U1-A compares the DC level from Q2 to a 0.5 V reference to signal the presence of air by sending EMPTY (121-5) high. If water is present, the input of Ui-A will be higher than the reference and the output will be low. R1 and R2 provide about 20 mv of switching hysteresis for noise immunity. The EMPTY (321-5) and BUBBLE (J21-6) lines are routed via the Sensor PWA to the 1/0 PWA. R3, R6, and R7 provide the threshold reference for both channels The “empty” reference is 0.5 V and the “bubble” level reference is 0.3 V. 4.4.6 DISPLAY PWA: A FUNCTIONAL DESCRIPTION (SEE FIGURE 8-7) The Display PWA consists of: ‘© Segment control (seven-segment common-cathode LED characters), © Display drivers. © LCD backlight control © Analog signal multiplexer. ‘See Figure 4-7 for a functional block diagram of the Display PWA. SEOMENT CONTROL, CHARACTER ‘CONTROL BACKLIGHT POWER Figure 4-7, Functional Block Diagram of the Display PWA 430-03426-002 4-35 ABBOTT LIFECARE $000 INFUSION SYSTEM ‘Theory of Operation Character LEDs and Drivers tcp ‘Current Sense Ampiitier Analog Muttiplexer ‘The LED characters U1 through US are driven by transistor arrays U7, U8, and U9. Digit drives are multiplexed via U9 with the microprocessor refreshing a new digit every 3 ms. A custom IC on the Main PWA provides the segment (SEGDA-SEGDP, P1-1 through P1-8) and character (CHARI-CHARS, P1-12 through Pi-16) drive signals. When SEGDA-SEGDP goes low, U7 and UB source current through the resistor networks RN1 and RN2 en route to the segments of the character LED that is active. The active character is selected by the CHARI-CHARS line that is low, sinking the segment currents through one of the transistors in U9. LEDI and LED2 are driven by the Power Supply PWA via LPLEDA (P1-23) and BPLEDA (P1-24) to indicate AC-line or battery power. ‘The liquid crystal display is a module composed of the 4x16 character dot matrix display, an electroluminescent backlight and board containing SMD integrated circuitry performing display interfacing and drive functions. Support circuits on the MAIN PWA and DISPLAY PWA provide contrast control and backlight power, respectively. Characters are written to and read back from the LCD via lines DSPDO through DSPD7 with LCDRS and LCDWR providing read/write control. The read capability allows the system to confirm that the data latches in the LCD module are functioning correctly Total display current flows to ground via the 1 0 current sensing resistor R3. The op-amp U6~A is configured as an amplifier with 2 noninverting gain of 11, by means of RN3 (7,8), RN3 (8,9) with input divider RN3 (4,5) and RN3 (5,6), reducing this to 10 times the voltage drop across R3. Thus the output of U6-A is a 10 mV/mA representation of the current flowing through the active LED character. The collector voltages of U9 and the current sense amplifier output comprise six out of the eight inputs to multiplexer U10. The remaining inputs are: © Flow monitor circuit (not used) ‘© OVPREF (P1-22) line from the Power Supply PWA. ‘The multiplex signals MUXO-MUX2 (P1-9 through P1-11) are ‘outputs for the custom IC on the Main PWA. Output MUXAD (P1-20) is delivered to the A/D converter on the Main PWA. In this way, a self-test of the display devices is performed at turn-on of the Infuser. 4-36 430-03426-002 4.5 MECHANICS: AN OVERVIEW. 430-03426-002 ‘The principal mechanical elements of the LifeCare 5000 Infuser System include the cassette, the ON/OFF cassette sensor switch, the infusion pumping mechanism (three motors), the ultrasonic location sensors ({luid sensors), a regulator, and interconnect/interface electronics. Whenever the cassette is locked into the operating position, the Infuser goes through a 15-second self-test to verily the integrity of internal systems. The properly installed cassette and closed door Activate the cassette sensor switch and applies power to the infusion Pumping mechanism. The operation of the source (plunger) motor moves the plunger, causing pumping action that increases pressure to the fluid pumping chamber. A piggyback motor activates a primary or secondary valve depending on the command input. A third valve-motor then opens ‘or closes an inlet valve or outlet valve to control fluid into the chamber. 437 ABBOTT LIFECARE $000 INFUSION SYSTEM. ‘Theory of Operation 4,5.1_THE CASSETTE: A FUNCTIONAL DESCRIPTION ‘The Infuser cassette operates on a fluid displacement principle, in conjunction with the mechanism, to deliver fluid volumetrically (see Figures 4-8 through 4-10). Refer to the System Operating Manual for a thorough description of the major functions of the cassette See Figure 4-10 for a diagram of the fluid path in the cassette. REGULATOR PRIMARY ACTUATOR INLET VALVE AIR-IN-LINE SECONDARY INLET VALVE DETECTOR | (DISTAL) (PIGGYBACK) pressure —_| | SENSOR 1 AIR-IN-LINE, (DISTAL) DETECTOR |_-2 (PROXIMAL) Locator | ©)| casserre sensor OUTLET CASSETTE VALVE SPRING LOADER PLUNGER [NLET VALVE Figure 4-8. Mechanical Elements On the Mechanism Assembly — ‘A View Behind the Cassette Door 7 Apne ine sevestea bpessune MET VALVE Figure 4-9. Major Elements of the Cassette (Dual-Channel Cassette shown) 4-38 430-03426-002, SECONDARY INLET | ~<— sECoNDARY VALVE <— 2.2 ML FLUID VOLUME INLET VALVE — ~<— PUMPING CHAMBER —<— OUTLET VALVE ~+—— PRESSURE SENSOR AIR-IN-LINE DETECTOR ——>> (DISTAL) GRAVITY FLOW 430-03426-002 4-39 ABBOTT LIFECARE 5000 INFUSION SYSTEM ‘Theory of Operation ‘The cassette contains two chambers separated by the inlet valve. ‘The upper. or air trap, chamber receives fluid from the IV container through either the primary or secondary valve. The purpose of the air trap chamber is to collect air bubbles coming from the IV lines and container and to prevent air from entering the pumping chamber below. The volume of the air trap chamber allows a substantial amount of air to be collected before the cassette needs repriming. However, the software keeps track of the air collected and calls for a backprime should the limit be reached. ‘The lower chamber is called the pumping chamber and receives fluid from the air trap chamber through the inlet valve and expels fluid through the outlet valve when the diaphragm covering the pumping chamber is deflected by the plunger. ‘The pumping cycle begins when the outlet valve is opened and the diaphragm is deflected by the plunger expelling the fluid. At the end of the pumping stroke (approximately 0.08" or 2.0 mm) the outlet valve is closed, the inlet opens and the plunger retracts, allowing fluid to refill the pumping chamber. At this time the inlet and outlet valves are reversed and the cycle repeats. ‘A bubbie detector located between the primary valves and the air trap will detect air entering the air trap. A proximal air-in-line alarm will sound when a predetermined amount of air is detected Similarly, a second bubble detector located distal to the pumping ‘chamber will sound if air is detected and prevent it from reaching the patient. ‘A pressure sensor located distal to the pumping chamber will monitor pressure on the distal side of the cassette ‘A flow regulator is incorporated in the cassette distal end. This can be used to manually control the flow when the cassette is not inserted in the pump. ‘When the cassette is inserted in the door and the door is closed a ‘mechanism in the pump opens the regulator to allow flow to be controlled by the pump. Upon opening the door, the same mechanism closes the regulator, insuring no flow to the patient 4.5.2 THE MECHANISM ASSEMBLY: A FUNCTIONAL DESCRIPTION ‘The mechanism assembly: ‘© Tums the cassette ON/OFF switch to ON when the cassette is properly installed and the door is closed. ‘© Moves the plunger to cycle with stroke length for delivery of 0.33 mL of fluid. © Contains a stepper motor that controls the delivery chamber inlet and ouuet valves of the cassette. ‘Motors and Valves 430-03426-002, ‘© Contains a piggyback stepper motor that controls the primary ‘versus the secondary valves of the cassette, © Is 2 fully self-contained unit. The motors are phased and matched for proper operation. ‘The major assemblies included in the mechanism are: ‘The primary/secondary valve assembly. ‘The input/output valve assembly. ‘The plunger drive assembly. ‘The cassette door. ‘The bubble sensor. ‘The pressure sensor. During infusion, the plunger motor drives a nut that is coupled to a lead screw. The motor action and screw move the plunger forward, causing the delivery of 0.33 mL of fluid per cycle. In this manner, plunger motion synchronizes with the action of the valve motor, providing controlled fluid delivery. ‘The pumping action of the mechanism derives from an assembly comprising two stepper motors with attached valve assemblies, while another stepper motor moves the plunger. One motor and the associated valve assembly controls the delivery chamber inlet and outlet of the cassette. The second motor, commonly known as the piggyback motor, and the associated valve assembly controls the primary versus the secondary inlet. The motor in the plunger drive assembly controls plunger movement, ‘The Primarw/Secondary Valve Assembly Note: The input/output valve assembly is very similar to the primary/secondary valve assembly. Both perform similar but ‘opposite functions and coniain like parts. Because the assemblies are s0 much alike only the primary/secondary valve assembly is discussed here. The primary/secondary valve assembly contains a motor designed to rotate an eccentrically-mounted ball bearing. When positioned at the top dead center, this bearing can rotate 12 steps (90 degrees) left or right. Rotation causes one valve to open and the other to close. Rotation clockwise from home position opens the primary valve and closes the secondary valve. Valve closing is accomplished with a force from a spring. This assembly consists of: © A piggyback stepper motor with attached ball bearing and flag. © Two levers and associated valve pins. ‘The flag passes through an interrupter module as it rotates with the shaft of the piggyback motor. ABBOTT LIFECARE $000 INFUSION SYSTEM ‘Theory of Operation ‘The lever is the connecting link between the eccentrically-mounted ball bearing and the valve pin. The lever also serves as an actuator device in the event of a broken main valve loading spring. When this occurs, a small diameter spring mounted to the bottom of each lever then automatically acts as a safety spring. The safety spring positions the primary lever in the interrupter module to cause the alarm code 79 and Infuser shutdown. To determine home position every time the Infuser turns on, a pin ‘on the motor eccentric (combination of shaft, bearing, and cam) ‘comes in contact with a finger attached to the motor plate. ‘The Plunger Drive Assembly “The plunger drive assembly contains a stepper motor designed to rotate one and two-third revolutions per cycle. Every one and ‘wo-third rotation of the motor results in displacement of 0.33 mL of fluid. The motor then reverses, the plunger returns to home position, and the cycle repeats for the duration of fluid administration. This assembly consists of: © A stepper motor. © A thrust ball bearing © A coupling assembly: = Not - Wave Washer = Coupling Housing ~ Flag A plunger home collar A screw. A plunger. ‘A plunger guide leaf spring. ‘The thrust ball bearing rests against the motor mounting base. As the cassette displaces fluid, the resulting load (due to pumping action and backpressure) is absorbed axially onto this bearing. ‘The coupling assembly provides the mechanical means for a fixed dead-center location of the plunger. It accomplishes this by holding the plunger in true position using a special plastic nut which moves freely on its axis regardless of misalignment between the motor and plunger. A wave washer applies a constant spring load against the rut ensuring the fixed location while allowing the nut to still move freely as needed in any angular direction. This assembly also contains a flag that determines home position of the plunger as well 4s the number of pumping steps. Each time the Infuser turns on, the “warm-start or cold-start”™ logic causes the motor to rotate until the plastic nut comes in contact with a mechanical stop. The motor automatically reverses aa 40-02426-002 ‘until home position is determined. From home position the infusion ‘cycle will start. As the motor rotates. the flag will pass twice through the interrupter module and then the motor will stop momentarily, return to home position, and repeat the pumping cycle. ‘The screw converts motor rotation into linear pumping motion. It is ‘confined on one end by a nut and on the other end by a plunger guide leat. ‘The plunger guide leaf and the plunger comprise one unit that ‘cannot be separated. Yet it works in conjunction with the coupling assembly s0 that the plunger moves freely in any angular direction. 4.6 MONITORS AND DETECTORS: An Overview ‘The system consists of fluid sensors in the mechanism assembly and two bubble sensor parts in the cassette, microprocessor-controlied flow alarm algorithms, and associated electronics. Operation of ultrasonic bubble sensors detect the presence of air at the inlet and outlet of the cassette pumping chamber. 4.6.1_PRESSURE MEASURING SYSTEM: A FUNCTIONAL DESCRIPTION 430-03426-002 Distal Occlusion Distal occlusion represents detection of an occluded administration set distal to the cassette. ‘The pressure within the cassette is measured by sensing the strain in a four-element strain gauge bridge bonded to a steel leaf spring. ‘The microprocessor monitors the absolute pressure. Exceeding the absolute or pressure limit will result in a DISTAL OCCLUSION alarm and pumping will stop. ‘The distal occlusion alarm is triggered under the following conditions: © The measured pressure exceeds 10 psi (70 kPa) for 1.2 seconds. © The measured pressure exceeds the user-selected pressure limit for 12 seconds. © The instantaneous pressure is greater than 10 psi (70 kPa) and the plunger motor slipped. © The measured pressure exceeds user-selected pressure limit at the time the START touchswitch is depressed. ABBOTT LIFECARE 5000 INFUSION SYSTEM Theory of Operation Proximal Occlusion Proximal occlusion is the detection of an occluded primary or secondary administration set proximal to the cassette. Detection happens by means of monitoring the output of the pressure sensor and immediately following opening of the outlet valve. If the Proximal line is occluded, a vacuum forms in the pumping chamber during the fill cycle and a negative spike should occur upon opening the outlet valve. 4.6.2_AIR-IN-LINE DETECTION ‘Proximal Air-in-Line A proximal air-in-line alarm is triggered if either of the following occurs: © Air is detected by the proximal air sensor for a continuing bolus of air equivalent to about 600 uL. © Air is detected for intermittent cumulative boluses of air equivalent to about 1.2 mL. When cumulative air boluses equivalent to about 1.2 mL are registered and the Infuser is programmed for secondary delivery, an autobackpriming function is triggered in order to backprime excess accumulated air into the secondary container (see operating manual for further details) ‘Distal Air-in-Line A distal air-in-line alarm is triggered if either of the following occurs: © Air is detected by the distal air sensor for a continuing bolus of air equivalent to about 100 wL. © Air is detected for intermittent cumulative boluses of air equivalent to about 240 ul out of 2 mL total volume. When the cassette door is opened, the detector is reset. Before the alarm is sounded the pump will push the air bubble about 20 motor steps forward in the tubing to a position where it can be visually inspected. 4.6.3 MALFUNCTION DETECTION: A FUNCTIONAL DESCRIPTION ‘The Infuser can diagnose two types of hardware malfunctions: those that are detected during self-testing, and those that occur during normal operation. Refer to Table 4-2 for a list of all alarm and malfunction codes. Refer to Table 6-1 for problem diagnosis, probable causes, and recommended corrective actions, where applicable. Codes can be reviewed by pressing the REVIEW/CHANGE touchswitch twice during the first 3- to $-second time interval after closing the door. A screen on the LCD will then show the last 15 alarm and/or malfunction codes, with the most recent appearing at the lower right-hand corner. 7 MODES OF DELIVERY (DIP SWITCH OPTIONS) ‘The Infuser has six delivery modes, as shown in Figure 4-11. See Table 4-3 for a summary of flow parameters for the Infuser. (Single Channel) MACRO SECONDARY (Dual Channel, ‘Single Dose) MACRO MULTIDOSE (Dual Channel, Multidose) MICRO (Single Channel) MICRO SECONDARY (Dual Channel, ‘Single Dose) MICRO MULTIDOSE (Dual Channel, Multidose) 430-03426-002 LIFECARE 5000 DUAL CHANNEL LIFECARE MULTIDOSE 5000 LIFECARE 5000 MICRO MODE LUFECARE 5000 MICRO MODE DUAL CHANNEL LIFECARE 5000 MICRO MODE MULTIDOSE 4-45 ABBOTT LIFECARE 5000 INFUSION SYSTEM ‘Theory of Operation 4.7.1_Changing Modes of Delivery To change dip switch options, perform the following steps: 1. Open the cassette door and remove the cassette. 2. Find the dip switch cover located at the top left comer on the back of the Infuser. Remove one screw and the cover to expose the dip switch selectors. 3, Set the appropriate setting for the desired infusion delivery mode (see Figure 4~11). 4. Verify the new delivery mode by closing the cassette door (with a cassetie properly installed in the door) or by manually activating the cassette sensor pin. Either procedure ‘automatically reveals the screen display of the current delivery mode. 5. Secure the dip switch cover properly in place with its mounting screw. Note: Changing the configuration of the dip switch erases previous settings from memory. CAUTION: Hospital personnel should verify the Infuser's flow configuration, ie, micro vs macro and single vs multidose, to ensure proper use of the Infuser. of Infuser Flow Parameters 1 = 9999 mL. 15 minutes 1-999 mL/hr | 1 - 9999 mL fe kee 0.1 - 99.9 mL/hr] 0.1 - 999 mL 0.1 - 99.9 mL/hr} 0.1 - 999 mL 15 minutes 0.1 ~ 99.9 mL/hr to 24 hours User selectable from approximately 0.1 - 8 psi (0 - 55 kPa) 5.0 MAINTENANCE AND FUNCTIONAL DEMONSTRATION 430-03426-002 SH ABBOTT LIFECARE 5000 INFUSION SYSTEM Maintenance and Functional Demonstration (BLANK PAGE) 42 430-03426-002 5.0 MAINTENANCE AND FUNCTIONAL DEMONSTRATION ‘This section contains maintenance instructions for the LifeCare 5000 Infusion System. Maintenance includes both cleaning and inspection for damage. Procedures provided in this section are for the demonstration of the functional operation only and do not constitute an evalu: the Infuser as to its calibration or specification compliance. Keeping the Infuser clean promotes system longevity and trouble-free operation. Accumulation of dust or spilled fuids on the cassette door and housing of the system can affect proper operation. Follow hospital protocol for setting up a cleaning schedule. 430-03426-002 © Clean the exposed surfaces of the Infuser with a soft lint-free cloth dampened with one of the cleaning solutions listed in [rssreon | Full strength 1 part Edisonite in 2 parts water (A registered trademark Full strength of Linbro Scientific, Ine.) ‘A mild solution of soapy water may also be used, Remove soap residues with clear water. Do nor use solvents that ate harmful to plastic, such as ethy! alcohol or acetone. Do not use abrasive cleaners. (A registered trademark of Arbrook Laboratories) pHisoHext (A registered trademark of Winthrop Laboratories) ‘Super Edisonite® (A registered trademark of S.M. Edison Chemical Co.) 1x8 5-3 ABBOTT LIFECARE 5000 INFUSION SYSTEM Maintenance and Functional Demonstration © Clean the cassette door with a soft lint-free cloth dampened with one of the cleaning agents described in Table 5-1 or a mild solution of soapy water. A small, non-abrasive brush may be useful for dislodging dirt from the instrument's housing and subsystem chassis components. For thorough cleaning of the ‘cassette receptacle, disconnect the cassette door from the doorlatch by pressing the door release tab (see Figure 5-1). Use cotton swabs to clean the pins. No other routine maintenance is necessary, except as required by hospital policy. CAUTION: Do not immerse the Infuser in liquids. This could result in electric shock and will damage the instrument. Do not allow liquids to enter the electronics compartment. CAUTION: Fluids spilled on the infusion pumping mechanism or sensors could affect system performance. Remove any spilled fluids with a soft lint-free cloth or swab. Dampen the ‘mechanism or sensors with water only if needed. DOOR RELEASE TAB DOOR LATCH IN OPEN POSITION PUSH OUT DOOR RELEASE TAB TO RELEASE CASSETTE DOOR DO NOT INSERT HARD OBJECTS IN Figure 5-1. Cleaning the Mechanical Elements Behind Cassette Door 4 ar9-0426-002, $1.2 Sanitizing The Infuser 0 If the LifeCare 5000 Infusion System has been in an isolation area, sanitize only the external surfaces of the system, using any of the solutions listed in Table $-1 CAUTION: DO NOT sterilize by heat, steam, ETO, or radiation, as these methods will cause the instrument to malfunction. 5.1.3 Inspecting The Infuser Periodically, the Infuser should be visually inspected for signs of defects such as worn accessories, broken instrument connections, damaged cables, and marred surface areas. This is particularly true after repairing or cleaning. Replace any defective external parts. ‘The Infuser should be inspected at least annually or more frequently as required by local regulations. S14 Battery Maintenance 0 Proper battery use and maintenance are essential for optimum ‘operation of the Infusion System. Overview ‘The batteries are intended to be used for emergency backup and temporary portable operation. If the Infuser is used frequently for portable operation, the battery life may be significantly reduced. As a general rule, the more often the battery is discharged and recharged, the sooner it will need replacement. To prolong battery life, always keep the unit plugged in when AC power is available. ‘Three factors that most commonly impact Infuser battery life are the depth and frequency of discharge, and the length of the recharge period. Factors such as storage time and room temperature may also affect battery life. Depth of Discharge When the battery is discharged below 7.4 VDC while the Infuser is operating, the LOW BATTERY alarm sounds. CAUTION: As soon as the LOW BATTERY alarm sounds, plug the Infuser into AC power, Although it is not recommended to continue running the Infuser on battery power at this point, the battery will continue providing power until it is discharged to 6.4 VDC (approximately 1/2 hour for a new, fully charged battery operating at 125 mL/hr). At this point, the DEAD BATTERY alarm is activated and Infuser operation ceases. 430-03426-002 5-5 ABBOTT LIFECARE $000 INFUSION SYSTEM ‘Maintenance and Functional Demonstration. If the batery is frequently discharged to the DEAD BATTERY threshold, the battery life will be compromised due to three conditions: ‘© Sulfation will occur when the battery is left in a discharged state. A layer of insulating lead sulfate crystal forms on the plate surfaces. The more extensive this layer, the more difficult it is to recharge the battery. When sulfation is ‘complete, the battery cannot be recharged and must be replaced. ‘© The sulfuric acid in the electrolyte solution will lose its sulfate ion concentration and become less conductive. This reduction in charge carrying ability causes the cell to have a higher internal impedance, thus requiring a longer recharge time. The battery never quite recovers from this dead battery condition and degrades somewhat each time it reaches this condition. © The lead sulfate present at the plate surfaces goes into solution. During recharge, the lead sulfate and the water Present in the electrolyte solution convert to sulfuric acid, A by-product of this chemical reaction is a lead precipitate. When this builds up to a point where it shorts between a plate pair, the cell fails Recharging ‘The battery can be recharged to 80% of previous capacity after a 24-hour recharge period. To bring the battery to full capacity, recharge for 72 hours. 5.2 FUNCTIONAL DEMONSTRATION. Several procedures are performed to check the function of the Infuser. These procedures should be performed in accordance with hospital protocol. If the Infuser fails during any procedure, contact the local Abbott Field Service Representative or the Abbott Technical Services Cenual Otfice. WARNING: SERVICE INSTRUCTIONS ARE FOR USE. ONLY BY QUALIFIED ABBOTT-TRAINED BIOMEDICAL ENGINEERS (BMEs), BIOMED-ELECTRONICS TECHNICIANS (BMETs), OR ABBOTT SERVICE PERSONNEL. TO AVOID PERSONAL INJURY OR INSTRUMENT DAMAGE, DO NOT PERFORM ANY REPAIR OR CORRECTIVE ACTION UNLESS YOU ARE FULLY TRAINED AND AUTHORIZED TO DO SO. USER-SERVICEABLE PARTS ARE LIMITED TO THE BATTERY, FUSES, AND LINE CORD. THERE ARE NO USER-SERVICEABLE COMPONENTS INTERNAL TO THIS DEVICE. WARNING: POSSIBLE EXPLOSION HAZARD IF SERVICED OR REPAIRED IN THE PRESENCE OF FLAMMABLE ANESTHETICS. CAUTION: Observe appropriate “electro-static discharge” Practices when servicing the LifeCare $000 Infusion System. From outside the Continental U.S.A., contact the nearest Abbott Representative 5.2.1 Power System Performance AC-line Operation Verify AC-line operation in the following manner: 4. Connect the Infuser to an appropriate hospital-grade receptacle. Leave the cassette door open. 2. The green indicator AC-plug symbol should light up. The illuminated symbol verifies that the Infuser is operating under AC power. Battery Oneration Verify battery operation in the following manner: 1. Temporarily disconnect the Infuser from the receptacle. Install 2 cassette and close the door. 430-03426-002 $7 ABBOTT LIFECARE $000 INFUSION SYSTEM ‘intenance and Functional Demonstration 2. The red indicator battery symbol should light up. The illuminated symbol verifies that the Infuser is operating under battery power. 3. Reconnect the Infuser to an appropriate hospital-grade receptacle. §.2.2_ Software Revision Level Check Software Revision Level Check can be invoked when the cassette is installed properly in the cassette receptacle and the door is closed. ‘The Infuser then enters the SELF-TEST status. When tests prove successful, the LCD screen will display “Self Test: OK." At this time, simply press the REVIEW touchswitch once and the software revision will be shown on the lower right-hand comer of the screen display. §.2.3 Screen Display Integrity ‘The light emitting diode (LED) screen display integrity is tested automatically by the microprocessor on the Main PWA each time the door closes. Verify that the microprocessor executes LED functions in the following manner: 1, Install a cassette and close the door. 2. Observe that the decimal points on the five LEDs illuminate immediately after closing the door. Also check display integrity bby looking for complete character segments and backlighting, 5.2.4 LCD Verification ‘The liquid crystal display (LCD) is tested for overall operation automatically by the microprocessor on the Main PWA each time the door closes with an installed cassette. Full LCD operation should also be verified visually, using the following steps: Install a cassette and close the door. 2. Wait a few minutes for the completion of the self-test. Then verify that the LCD exhibits adequate contrast and viewing angle. Check that the backlight illuminates and character Segments are not missing as the message appears. 2.5 Touchswitch Operation 9. To verify proper touchswitch operation: Install a cassette and close the door. 2. Wait approximately 15 seconds for the completion of the self-test. Then press each of the touchswitches in sequence. 8 40-0144-07 Each touchswitch should emit a short beep the moment a touchswitch is pressed. Failure to emit a beep indicates a failed touchswitch. Note: If a touchswitch is stuck or pressed out of sequence during set up, the LifeCare 5000 Infuser emits an audible alarm or “flutter” tone. Also, the malfunction code 45 should appear within two minutes and 40 seconds if a touchswitch is stuck closed. BCE Diether Aiceamacy see See cece teee cere 1, Insert a primed cassette with a 21~gauge butterfly needle attached into the pump and close the door. Configure unit for elivery from primary and secondary fluid containers. Place the needle above a graduated cylinder (>10 mL capacity with 0.1 mL resolution). 2. Connect a 19-gauge or larger needle from a primed secondary set to the secondary inlet of the loaded cassette, or attach male adapter of primed secondary set to secondary port on loaded cassette. 3. Set primary for rate for 400 mL/hr and dose for 5 mL. Set secondary for rate for 400 mL/hr and dose for $ mL. 4. Press START and verify that pumping occurs. The unit should deliver $ mL from the secondary container then switch to the primary container. After the “DOSE END" and “KVO" messages are displayed and the audible alarm sounds, press RESET. 5. The total volume delivered into the graduated cylinder should be between 9.5 and 10.5 mL. The display should read 10 mL. Continue the test until three consecutive readings fall within the range. If the initial delivery falls below 9.5 mL, check the set for air. If attempts to get three consecutive readings fail, reprime or change the pump set and repeat the test. 7_Nurse-Call Alarm T: ti 1. Connect the nurse-call simulator (Ohmmeter) to the murse-call Jack. 2. Set primary the delivery rate for 400 mL/hr and the dose limit for 2 mL. 3. Press START and verify that pumping occurs. After the “DOSE. END" and “KVO” messages are displayed and the audible alarm activates, verify the nurse-call light activates or ‘Ohmmeter shows zero. 430-03426-002, 9 ABBOTT LIFECARE 5000 INFUSION SYSTEM Maintenance and Functional Demonstration 5.2.8 Bubble Sensor Alarm: Alr-In-Line Detection ‘The Infuser contains both a proximal and a distal air-in-line sensor. To check the proximal (upstream) air-in-line sensor: 1, Install @ properly primed cassette and close the door. 2. Set the Infuser for a delivery rate of 250 mL/hr and a dose limit of 50 mL. Start the infusion. 3. After 1 minute, invert the drip chamber from the bag or bottle so that air enters the proximal line. 4. Observe that as air moves down the proximal tubing and enters the cassette, a PROXIMAL AIR-IN-LINE alarm occurs. The proximal air sensor is operating properly if the AIR-IN-LINE alarm sounds. If no alarm sounds, it is an indication of a failed air-in-line sensor. To check the distal air sensor: Note: Before checking the distal air sensor, repeat the proximal air-sensor challenge several times until the air-trap chamber of the ‘cassette fills with air. 1, Open and close the door to clear any alarm conditions. Press the START touchswitch. Observe air bubbles passing from the cassette pumping chamber to the distal tubing, 3. Check the display for the message “AIR-IN-LINE" and look for air in the distal tubing. Listen for an audible alarm. No alarm indicates failure of the distal air sensor. If the CHECK CASSETTE alarm occurs, reprime the cassette and repeat the distal air sensor check. Note: The distal AIR-IN-LINE alarm will only sound if a bubble approximately 100 iL or larger is detected. 5.2.9 Pressure Sensor Operation ‘The pressure sensor operation requires a set-up with a constant cassette distal pressure and an accuracy better than 0.5 psi (3.5 kPa). To verify accurate pressure sensor operation: 1, Install a primed cassette and close the door. Set the pressure limit to 8.0 psi (56 kPa). Set the Infuser for a delivery rate of 150 mL/hr and a dose limit of $0 mL. Set the cassette backpressure to zero. 2. Press the START touchswitch. Wait at least 1 minute and then press the REVIEW/CHANGE touchswitch twice to show st0 430-03426-002 the current operating pressure. This pressure must be 0+ 1.0 psi (0 7.0 kPa). Increase the cassette backpressure to 6.0 psi. Observe this new operating pressure. This pressure must measure 6.0 + 1.0 psi (42.0 + 7.0 kPa). Note any deviations. Troubleshoot and isolate the cause as needed. Increase the cassette backpressure until OCCLUSION alarm and the gauge pressure measure 8.0 +t 1.5 psi (55.0 & 10.5 kPa). Note any deviations. Troubleshoot and isolate the cause as needed. 5.2.10 Battery Charger Circuit 430-03426-002 To exercise the battery charger circuit: rent 1. Disconnect the battery from the pump (see Section 6.2.1) and set aside. 2, Substitute a 470 9 (0.5 W) resistor in parallel with a 100 uF capacitor in place of the battery. 3. Plug the pump into AC power. The voltage across the resistor should measure 9.40 + 0.1 VDC. ife ional) To measure the battery life: 1. Plug the LifeCare $000 Infuser into an AC receptacle without a cassette for a minimum of 24 hours to charge the battery. 2. Set the Infuser for a rate of 125 mL/hr and a dose limit of 600 mL. Note: Nominal battery life (with new, fully charged battery pack) is 6 hours of operation at 125 mL/hr. 3. Start the infusion. Wait for the DOSE END alarm. Should the LOW BATTERY alarm occur before the DOSE END alarm, assume that the batteries of the battery pack are below 80% of nominal. Replace the battery pack (see Section 6.2.1) | Encl Refer to UL $44 and IEC-601-1 documentation for requirements for the leakage test. Connect device to an approved electrical safety analyzer, Leakage Current should not exceed 100 4A, but be greater than 2 wA (open ground). S11 ABBOTT LIFECARE 5000 INFUSION SYSTEM Maintenance and Functional Demonstration 5.2.13 Grounding Continuity Verification Refer to UL 544 and TEC-601-1 documentation for requirements for the continuity test. Using a safety analyzer, measure ground lug of AC connector. Resistance should not be greater than 100 mf. Note: If leakage exceeds the limit in any of the above tests, contact the Technical Services Center. 5-12 430-03426-002 6.0 TROUBLESHOOTING 430-03426-002 o ABBOTT LIFECARE $000 INFUSION SYSTEM ‘Troubleshooting (BLANK PAGE) 6 430-02426-002 6.0 TROUBLESHOOTING ‘This section contains basic troubleshooting techniques and a convenient troubleshooting guide for use by Abbott-qualified technical personnel who maintain the LifeCare 5000 Infusion System. Also included are instructions for changing the battery ack, the fuses, and the AC-line cord. WARNING: SERVICE INSTRUCTIONS ARE FOR USE ONLY BY QUALIFIED ABBOTT-TRAINED BIOMEDICAL ENGINEERS (BMEs), BIOMED-ELECTRONICS TECHNICIANS (BMETs), OR ABBOTT FIELD SERVICE PERSONNEL. TO AVOID PERSONAL INJURY OR INSTRUMENT DAMAGE, DO NOT PERFORM ANY REPAIR OR CORRECTIVE ACTION UNLESS YOU ARE FULLY TRAINED AND AUTHORIZED TO DO SO. USER-SERVICEABLE PARTS ARE LIMITED TO THE BATTERY, FUSES, AND LINE CORD. THERE ARE NO USER-SERVICEABLE COMPONENTS INTERNAL TO THIS DEVICE. Ifa failure occurs that cannot be corrected using the Troubleshooting Guide, contact the Technical Services Center. TECHNICAL SERVICES CENTER gy 1-800-ABBOTT-3 (1-800-222-6883) To order parts, accessories, or manuals, contact the Technical Services Center. FR F1o™ outside the Continental U.S., contact the nearest Abbott Representative. 430-03426-002 6-3 ABBOTT LIFECARE 5000 INFUSION SYSTEM Troubleshooting From U.S. sites, please send all returns, prepaid, ABBOTT CRITICAL CARE SYSTEMS TECHNICAL SERVICES CENTER 980 Linda Vista Avenue Mountain View, California 94043 From locations outside the U.S., contact your Abbott Representative. Do not return to Abbott Critical Care Systems without prior approval from the Technical Services Center. ‘Ask your Abbott Professional Hospital Representative or call the Technical Services Center for information about the Abbott Extended Warranty Program for the LifeCare 5000 Infuser. 6.1 TROUBLESHOOTING GUIDE. Before troubleshooting, perform a preliminary inspection of the Infuser. Ascertaining damaged components visually may help target trouble areas. The following is a suggested checklist: © Inspect the front panel of the Infuser for damage. © Check that the doorlatch closes properly. © Using the instruction in Section 6.2.2, remove the AC-tine cover from the power cord and test port. This will allow access to the fuses. © Check both AC power line fuses. Replacing them may correct, any faults. © Mechanically inspect inside the cassette receptacle for broken ‘material or loose objects. This includes debris, metal, or plastic. Also check for build-up of spilled fluids. '® Inspect the dip switches for damage or incorrect setting (see Figure 4-11). © Check for the fault symptoms listed in Table 6-1 and Table 6-2, following the corrective procedure if a fault is isolated, ‘Table 6-1. Troubleshooting Guide ~ External Malfunctions Note: The following fault symptoms are detected by ‘observation only. They occur without the Infuser sounding an audible alarm or storing an alarm code in memory, Audible Alarm Operation No audible alarm Defective piezo alarm. Call Technical Services Center. Defective audio alarm circuit ‘on Power Supply PWA. Call Technical Services Center. Defective audible alarm switch. Unable to change alarm volume Call Technical Services Center. ‘Battery Operation Battery symbol lights up while Infuser under AC-line Power. Blown AC-line fuse. Check power plug and cord. © Verify blown fuse and replace it. If fuse blows again, call Technical Services Center. Defective primary transformer.| @ Call Technical Services Center. Short operating time 10 Battery not being recharged LOW BATTERY alarm. sufficiently (minimum of 24 hours); battery is defective or battery life is exceeded. Recharge battery for 72 hours. If problem persists, replace battery. Eluid Flow Fluid delivery is greater or lesser than programmed rate. Replace and prime administration set. Refer to ‘Operating Manual for instructions. Maladjusted/defective Infuser mechanism. Call Technical Services Center. ‘Nurse=Call Alarm Nurse-call alarm does not Defective nurse-call circuit. activate during alarm condition. Call Technical Services Center. 430-03426-002, 6-5 ABBOTT LIFECARE $000 INFUSION SYSTEM Troubleshooting Note: For the following fault symptoms, the Infuser will sound an audible tone, display an alarm message, and store an alarm code in system memory. STOPPED DISTAL LINE OCCLUSION STOPPED PROXIMAL OCCLUSION Primary Secondary STOPPED PRESSURE OUT OF RANGE STOPPED AIR IN LINE PROXIMAL © Distal line kinked, distal clamp closed; clotted IV site. Pressure limit set 100 low. Infuser positioned correctly. Proximal line obstructed. Secondary container not connected. Single channel cassette used for dual channel delivery. Distal line pressure is below normal range. Defective cassette. Air has been detected in cassette proximal line due to: © Empty container. © Cumulative air-in-line volume exceeded due to outgassing or successive air segments introduced by underfilled secondaries. ‘© Damaged cassette or adapter. © Proximal line occluded. © Examine distal line for kinks} or internal obstructions. © Reset pressure limit. © Reposition Infuser at or above mid-axillary line of patient. Examine line kinks, closed ‘clamps or internal obstructions. Check to be sure 19-gauge or larger needle is used. Replace with dual channel cassette Position Infuser at mid~ axillary line of patient. Replace cassette. If problem persists, return to Abbott for repair. Reprime administration set using the standard technique described in the Operating Manual. If using a dual-channel cassette, follow the special back- priming technique or use standard repriming technique. 40-02426-002 Table 6-1. STOPPED AIR IN LINE DISTAL BACK PRIME TO CLEAR AIR INTO SECONDARY, YES OR NO? STOPPED FOR 5 MINUTES DOSE END/KVO STOPPED CHECK SET REPRIME SET LOW BATTERY STOPPED DEAD BATTERY STOPPED DOOR OPENED WHILE PUMPING 430-03426-002, Troubleshooting Guide - External Malfunctions, continued Air has been detected in cassette distal line due to: © Excessive air in air wrap. © Incomplete priming, © Outgassing. © Damaged cassette Air has been detected in cassette air-trap chamber. © Door has been closed for 5 minutes without further programming. Primary dose has been ‘completed. ‘© Cassette leak (/O check) 1 Piggyback valve leak (Spike amplitude). Piggyback valve leak (detected by air sensor) ‘© Piggyback valve leak (unable to perform test after five tries), Battery has nearly discharged. Battery is fully discharged Door has been opened while unit is pumping, pie ‘© Reprime cassette using standard techniques. If alarm repeats, replace set. © If damaged, replace cassette. © Reprime cassette using standard technique when using a single channel cassette. Press RESET. Complete set-up and/or press START ‘or open door and remove cassette. Discontinue delivery or set another primary dose. © Reprime set. If alarm repeats, replace set. If alarm’ repeats again, return to Abbott for repair. © Clean valves. Connect Infuser to AC power. Connect Infuser to AC power. Close door. Press RESET. ABBOTT LIFECARE $000 INFUSION SYSTEM ‘Troubleshooting Intuser displays any of the following intemal malfunction codes, please call the Technical Services Center. ee aa ee fh ee | eee Stack Runaway Error. » © Faulty Main PWA (possible defective ROM, RAM, Processor or custom IC). Corrupted Critical Data. 21 © Faulty Main PWA (defective RAM). Watchdog Frequency Error. 22, 23 © Incorrect watchdog frequency. © Incorrect processor frequency. © Defective custom IC. ‘Watchdog Finds Processor Error. 4 © Defective processor. © Defective custom IC. Watchdog Does Not Reset Processor. 2s © Defective custom IC. Processor Internal 6 © Defective processor. Malfunction. Megat Instruction Trap. Fa © Defective processor. RAM Check Error. 28 © Defective RAM. Low ROM Checksum Error. 29 © Low ROM chip has failed. High ROM Checksum Error. 30 © High ROM chip has failed. ROM Revision Number Er © The high and low ROM chips are Does Not Match. not pant of the same software revision (version). 6-8 430-03426-002 Table 6-2. Troubleshooting Guide - Internal Malfunctions INTERNAL MALFUNCTIONS intemal maitunctions ait require factory repair (with the exception of codes 62 and 65). I the Intuser displays any of the following intemal maifunction codes, please call the Technical Center. Services © Loose cable, LCD; defective LCD module. LCD Display READ/WRITE Failure. LCD RAM Failure. © Defective LCD module. LED Display Failure. © Defective Display PWA. Audible Alarm Failure, © Defective piezo device. © Defective drive. © Defective test circuit Keyboard Failure. © Touchswitch stays closed more than 2 minutes and 40 seconds. © Defective front panel assembly. Plunger Motor Will Not Home {Glso sips or sticks). (© Plunger motor is stuck. © No power to motor, © Defective motor drivers. © Defective Sensor PWA. VO Valve Motor Will Not Home {also slips or sticks). © 0 valve is stuck. (To correct this condition, remove the obstruction. Do Rot return the Infuser to Abbott unless removing the obstruction does not Festore operation.) © 1/0 valve motor is stuck. © No power to motor. Defective motor drivers, Defective Sensor PWA. 430-03426-002 6-9 ABBOTT LIFECARE 5000 INFUSION SYSTEM Troubleshooting Table 6-2. Troubleshooting Guide - Internal Malfunctions INTERNAL MALFUNCTIONS Internal maitunctions ail require factory repalr (with the exception of codes 62 and 65). # the Infuser displays any of the following intemal malfunction codes, please call the Technical Piggyback valve is stuck. (To correct this condition, remove the obstruc- tion. Do not return the Infuser to Abbott unless removing the obstruction does not restore operation.) Piggyback Valve Motor will not Home (Also Slips Or Sticks). © Piggyback valve motor is stuck. © No power to motor. © Defective motor drivers. © Defective Sensor PWA. AID Converter Failure. © Unacceptable 2.5 V reference. © Defective A/D converter. Ultrasound Bubble Detector Failure. © Defective custom IC. © Defective Sensor PWA. © Defective Bubble Sensor PWA. Overvoltage Protect Failure. © Defective Power Supply PWA. © Defective custom IC. Distal Air Sensor Failed Ongoing Check © Defective Sensor PWA or Bubble Sensor PWA. Proximal Air Sensor Failed ‘Ongoing Check. © Defective custom IC or 1/0 PWA. ‘© Proximal air sensor if OFF when it should be ON. Piggyback Safety Spring Failed. © Defective mechanism. 6-10 430-03426-002 §.2_ PART REPLACEMENT INSTRUCTIONS 430-03426-002 ‘The following instructions are for use as an aid to the hospital technician and field service personnel in replacing the battery pack. fuses, and the AC-line power cord. They should not be executed by untrained personnel. Illustrations are provided as a visual aid for these instructions. The following tools are needed for replacing these pants: © Phillips screwdriver. © Needie-nose plier. © Flathead screwdriver. Note: Mounting hardware like screws, washers, or nuts come in different sizes and shapes. Retain and reuse mounting hardware or Teplace with identical items as needed for reassembly purposes. Do not substitute size or shape of hardware. WARNING: SERVICE INSTRUCTIONS ARE FOR USE ONLY BY QUALIFIED ABBOTT-TRAINED BIOMEDICAL ENGINEERS (BMEs), BIOMED-ELECTRONICS TECHNICIANS (BMETs), OR ABBOTT FIELD SERVICE PERSONNEL. TO AVOID PERSONAL INJURY OR INSTRUMENT DAMAGE, DO NOT PERFORM ANY REPAIR OR CORRECTIVE ACTION UNLESS YOU ARE FULLY TRAINED AND AUTHORIZED TO DO SO. USER-SERVICEABLE PARTS ARE LIMITED TO THE BATTERY. FUSES, AND LINE CORD. THERE ARE NO USER-SERVICEABLE COMPONENTS INTERNAL TO THIS DEVICE. 6-11 ABBOTT LIFECARE 5000 INFUSION SYSTEM ‘Troubleshooting See Figure 6-1 for the physical location of mounting hardware referenced in this procedure. The battery cover and battery pack may be removed in the following manner: 1. Using a soft flat surface and facing the back of the Infuser, (minipole side), lay the Infuser on the side opposite from the clamp knob assembly. 2. Remove two Phillips screws and split-lock washers from the two feet nearest the back cover. Remove one Phillips screw and split-lock washer that secure the battery cover to the main chassis. Slide the cover forward (away from the front cover) and remove it. - Grasp the battery pack and pull it out of the battery compartment 4. Disconnect the battery cable assembly from the Infuser. The battery pack is now detached. Set it aside and away from the Infuser. Figure 6-1. Battery Cover Removal 6.2.2_AC-Line Power Cord and Fuses Removal Remove the AC-line power cord and fuses as follows: 1. Position the Infuser on its rubber feet. 2. See Figure 6-2 for a physical location of mounting hardware. If needed, unbundle the power cord from the pole clamp or Velcro strap. Remove four Phillips screws, four #6 locking washers, and the AC-line cover from the rear housing cover. ‘Stow the AC-line cover and its mounting hardware away from the immediate working area. 3. Grasp the connector of the power cord and gently pull it from the male receptacle. Stow the power cord away from the immediate working area. Note: The fuse holder uses spring-loaded retainers to keep the fuses in position. The retainers may provide only a loose grip ‘on the fuses. Use care when removing the fuse holder so that the fuses do not suddenly fall out of the retainers. 4. Using a flat-blade screwdriver or needle-nose pliers, gently squeeze the tabs on the fuse holder and pull the fuse holder away from the AC-line receptacle assembly. 5. Place the fuse holder and its fuses on a flat surface. Remove and replace fuses as required. Figure 6-2. AC Power Cord and Fuses Removal 430-03426-002 6-13 ABBOTT LIFECARE $000 INFUSION SYSTEM Troubleshooting 8.2.3, Minipole Removal Remove the wire-ring retainer from the bottom of the minipole, if needed, and then slide the minipole straight out of the pole clamp assembly. 7.0 WARRANTY 430-03426-002 oat ABBOTT LIFECARE 5000 INFUSION SYSTEM Warranty (BLANK PAGE) LO_WARRANTY 430-03426-002 ‘The LifeCare 5000 Infusion System has been carefully ‘manufactured from high quality components. It is warranted to be free from defects in material and workmanship under normal use and service for a period of one year from the date of purchase. On Teturn to Abbott, the Infuser will be repaired or replaced within the terms of this warranty. ‘The warranty on the replaceable battery is limited to 90 days under normal use and service. Material returned to Abbott must be properly packaged and sent freight prepaid. ‘This warranty shall not apply in the event the LifeCare 5000 Infuser has been repaired by anyone other than Abbott-qualified service personnel, or altered in any way which, in Abbott's judgment, affects its stability or reliability, or if the serial number has been altered, effaced, or removed. THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED. 13 ABBOTT LIFECARE $000 SFUSION SYSTEM Warranty (BLANK PAGE) om 430-03426-002, 8.0 SCHEMATICS AND PARTS LISTS 430-03426-002 Ba ABBOTT LIFECARE 5000 INFUSION SYSTEM Schematics and Parts Lists (BLANK PAGE) a 430-03426-002 8.0 SCHEMATICS AND PARTS LISTS This section provides a convenient cross-reference for use with Section 4.0, Theory of Operation, and Section 6.0, ‘Troubleshooting. In it are prints of schematics for the LifeCare 3000 Infuser and component pants lists with reference designators. Also included is a list of spare parts 8.1 ABBREVIATIONS AND SYMBOLS 00 ‘The following abbreviations and letter symbols appear in the schematics and parts lists. 8.1.1 Letter Symbols ‘The letter symbols used in the schematics and as reference designators in the parts list include: U_ = integrated circuit Q = transistor CR = diode J connector (male) P= connector (female) Ro = resistor RN = resistor network F = fuses C= capacitor K = rey Y = crystal 8.1.2 Parts Lists Abbreviations Abbreviations used in the parts lists include: ASM = assembly PNL = panel cA cable PWA = printed wiring assembly CAP capacitor PWB = printed wiring board CER ceramic PWR power ckT circuit RBN ribbon CONN = connector R = resistor DIO diode RCPT = receptacle DRVR = driver RTANG = right angle DSPL = display SNSR = sensor GND = ground SKT = socket Ic integrated circuit. © SPLY = supply LKG locking SW = switch MECH = mechanism TA = tantalum MOT = motor XSTR = transistor MPU = main processor unit XTAL = crystal Por potentiometer PLGR = plunger 430-03426-002 83 ABBOTT LIFECARE 5000 INFUSION SYSTEM Schematics and Parts Lists 8.2 RECOMMENDED SPARE PARTS 0 DESCRIPTION =» QUANTITY = ORDER NUMBER ‘AG-line Power Cord 1 826-85559-002 Battery Pack 2 642-76002-002 AC Fuse 2 670-72543-001 Minipote 1 9295-01 Syringe Adaptor 1 9292-48 ‘Vial Adaptor 1 9293-48 ‘The spare pants listed above are for domestic models. To order spare parts for international models, contact your Abbott Representative. 8.3 DRAWING LIST Listed in Table 8-1 are schematics and pans lists for the LifeCare ‘5000 Infuser. Table 8-1. System Interconnect Schematic Figure 8-1 Not Applicable 249-03100-001 Main PWA Schematic Figure 8-2 Table 8-2 249-03304-002 1/0 PWA Schem: 249-03305-007 Figure 8-3 Table 8-3 Power Supply PWA Schematic Figure 8-4 Table 8-4 249-03308-003 (2 pages) Sensor PWA Schematic Figure 8-5 Table 8-5 249-03110-006 Bubble Sensor PWA Schematic Figure 8-6 Table 8-6 249-03322-006 Display PWA Schem: Figure 8-7 Tabie 8-7 249-03313-002 Note: Drawings are subject 10 change without notice. 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NeSENT ‘O1 93S-£ ‘G34 ‘AV IASI TANNYHO-N ‘134SON ‘HO-SISNVEL 206% AYHEY HO_SISNVEL *¢1S-8 MHOMISN ‘HOUSIEaE ‘%S WYO 001 ‘ALVUVCaS ‘dS-8 HYOMLBN “HOISTS ASL "MK 009 'BPIPNI “TWO ‘3G0/0 NOLLAOSaGaAVN ‘ThECO-Grt “ON Bumeg sneusyos ‘Oy 430-03426-002 ABBOTT LIFECARE 5000 INFUSION SYSTEM (BLANK PAGE) 12 430-03426-002, A AC-Line indicator, 4-22, 4-23 Power cord ordering, 6-3 removal, 6-13, Activity States ALARM, 4-9 OPERATING, 4-7 RESET, 4-7 ‘Address Decoder, 4-17, 4-18 ‘Address/Data Transceiver, 4-17 Air Trap Chamber, 4-39 Air-In-Cassette Detection distal, 4~30, 4-33 Proximal, 4-30, 4-33 Air-In-Line Sensors, 4-29, 4-30, 4-39, 4-43 testing, $-10 Air-in-Line Detection, 4-44 Alarm circuits, 4-8 codes, 4=14 reviewing, 4-45 conditions, 4-14, 6-5—6-8 history data, 4-14 transducer, 4~22 Amplitude Modulated Detectors, 4-32, 4-33, 4-34 Analog Multiplexer, 4-36 Analog Signal Muliplexer, 4-35 Analog-to-Digital Conversion, 4-16, 4-19 Audible Alarm, 4-7 control, 4-22, 4-23, 4-26 self-test, 4-27 testing, 4-6 volume settings, 4-26 Audio Processor, 4 Backup Capacitor, 4-23, 4-25 Ball Bearing, valve assembly, 4-41 Battery charger circuitry, 4-21, 4-27 life, test, $=11 430-03426-002, 1-3 ‘ABMUIT LIFECARE 5000 INFUSION SYSTEM index ack ordering, 6-3 removal, 6-12 warranty, 7-3 Power, indicator, 4-22, 4-23 Battery Maintenance, 5-5 Baud Rate Generator, 4-18 Bubble Sensor alarm test, $10 PWA block diagram, 4-33 description, 4-32 Bus Interfacing, 4-18 c Case, cleaning, 5-3 Cassette air-in-line detection, 4-3 description, 4-38 fluid path, 4-39 mechanical elements, 4-38 ressure-sensing capabilities, 4—3 Cassette Door, 4-7 cleaning, 5-4 Cassette Sensor Switch, 4-6, 4-29, 4-31, 4-37 Cautions, 4-46, 5-4, 5-5, 5-7 Checkout Tests. See Functional Demonstration Cleaning chassis components, 5-4 housing, 5-4 solutions, 5-3 Clock, 4-15, 4-18 CORE FAILURE state, 4-12 Codes, reviewing, 4-45 Cold-Stan, 4-42 Core Circuitry, 4-12 Counters, 4-17, 4-20 Coupling Assembly, 442 CPU, 4-18 Critical Data erasure, 4-13 integrity, 4-6 retention, 4-13, 4-18 Crystal receive, 4-34 sensitivity, 4-34 ABBOTT LIFECARE 5000 INFUSION SYSTEM index Current Sense Amplifier, 4-36 Custom Discrete Logic IC, 4-18 D Daa integrity, 4-6 monitoring, 4-6 retention, 4-13, 4-18 DC/DC Convener, 4-17 Delivery Accuracy Test, 5-9 Delivery Modes, 4-3, 4-20, 4-45 Detectors, description, 4-43 Dip Switches, setting delivery mode, 4-45, 4-46 Disassembly. See Part Replacement Instructions Discharged Battery, 4-7 Display Drivers, 4-35, 4-36 Display Integrity, 5-8 Display PWA, description, 4-35 Distal, air-in-line sensor, testing, 5-10 Distal Occlusion, 4-43 Driver Circuits, 4-20 Electrical Leakage, 2-3 Electronics, overview, 4-15 EPROM, 4-15, 4-18 Erasure, critical data, 4-13 Extended Warranty, 6-4 Exterior, cleaning, 5-3 F Failure Monitor, 4-5 circuit, 4-12 Flow Parameters, 4-46 Fluid Pressure, 4-37 sensors, 4-37 Four-Channel Multiplexed Inputs, 4-19 1-4 Functional Demonstration, 5-7 LCD Verification, 5-8 Power System Performance, 5-7 power system performance ‘AC-line operation, 5-7 battery operation, 5-7 Software Revision Level Check, 5-8 Fuses ordering, 6-3 removing, 6-13 G Grounding Continuity Verification, 5-12 H Hardware Malfunctions, 4-44 Hitachi CMOS Microprocessor, 4-18 Housing, cleaning, 5-3 vo flag information, 4-6 PWA block diagram, 4-19 description, 4-19 schematic, 8-9 Infuser Status Conditions, 4-5 Inlet Valve, 4-5, 4-29, 4-37, 4-39 Input Buffers, 4-20 Inspecting the Infuser, 5-5 Interfacing Signals, 4-19 K KVO (Keep Vein Open) Rate, 4-9 L LCD, 4-36 backlight control, 4-35 character control, 4-17 function, 4-7, 4-9 interface, 4-17 segment control, 4-17 430-03426-002 testing, 4-6 tion, $-8 LED display integrity, 5-8 latches, 4-17 refresh interrupt timer, 4-18 segment test current, 419 testing, 4-6 LED/LCD Interfacing, 4-18 Leakage Current to Metal Enclosure, $11 LOCAL CONTROL Mode, exiting, 4-6 Logic Circuitry, 4-20 M MALFUNCTION Alarm, 4-12 Macro Delivery Modes, 4-45, 4-46 Main Power Regulator, 4-31 Main PWA block diagram, 4-17 ‘components pars list, 8-8 description, 4-15 schematic, 8-7 Maintenance, 5-3 Malfunction Codes, 4-14 alarms, 4-14 core failures, 4-14 display failures, 4-14 miscellaneous, 4-15 pumping mechanism failures, 4-15 reviewing, 4-45 Malfunction Detection, description, 4~44 Malfunctions, hardware, 4-44 Manuals, ordering, 6-3 ‘Mechanics, overview, 4-37 ‘Mechanism Assembly, 4-41 description, 4-40 Memory Backup Power Supply, 4-23, 4-24 Memory Protection, 4-18 Micro Delivery Modes, 4-45, 4-46 Microprocessor, 4-17, 4-18 Minipole Removal, 6-14 Modes of Delivery, 4-3, 4-20, 4-45 Monitoring Data, 4-6 430-03426-002 1-5 ABBOTT LIFECARE 5000 INFUSION SYSTEM Index ‘Monitors, deseription, 4-43 ‘Motor Drivers, circuitry, 4-20 ‘Motor Power Supply, 4~20, 4-23, 4-24 Motor Supply Regulation, 4-23 Motorola Microprocessors, compatibility with, 4-18 MPU, 4-15, 4-17, 4-18 Mulidose Delivery, 4-46 macro, 4=45 micro, 4-45 Multifunction Timer, 4-18 Multiple Dose, 4-3 N Nominal Power Supply, 4-18 Nurse-Call Alarm circuit, 4-5, 4-9, 4-13 test, 5-9 ‘Nurse-Call Relay normally-closed, 4-20 normally-open, 4-20 ° Occlusion Pressure Limit Setting, retention in memory, 4-13 OFF Status, 4-5 Operating Modes LOCAL CONTROL mode, exiting, 4-6 SELF-TEST mode, 4-5 Operational Overview, 4-3 Optical Interrupters, 4-30 Optical Interruptors, 4-29 Outlet Valve, 4-5, 4-29, 4-37, 4-39 ‘Output Latches, 4-20 Overvoltage Protector, 4-22, 4-23 P Parallel 1/0 Ports, 4-18 Part Replacement Instructions, 6-11 Pans Lists Abbreviations, 8-3 PERIPHERAL FAILURE state, 4-12 ABBOTT LIFECARE 5000 INFUSION SYSTEM index Piezoelectric Transducer Pairs, 4-30 Piggyback stepper motor, 4-37, 4-41 valves, 4-29 Phunger, 4-5, 4-7, 4-30, 4-41, 4-42, 4-43 Phunger Drive, assembly, 4-41, 4-42 Plunger Guide Leaf, 4=43 Plunger Motor, 4-41 Power Circuitry ‘AC-line, 4-20 battery operation, 4-20 Power Control Logic, 4-22, 4-23 Power Cord, ordering, 6-3 Power Supply PWA. block diagram, 4-22 description, 4-20 Power Transformer, 4-21, 4-22 Power-Up/System Reset Control, 4-18 -34 Pressure Amplifier, 4-29, 4-31 Preamplifiers, 4-32, 4-33, Pressure Measurements, 4-19 Pressure Measuring System, description, 4-43 Pressure Selection, 4-46 Pressure Sensor, 4-39 testing, 5-10 Primary Delivery, 4-3 Primary Fluid Inlet Valve, 4-5, 4-37, 4-39 Proximal Air-In-Line Sensor, testing, $-10 Proximal Occlusion, 4-44 Pumping Chamber, 4-39 plunger, 4-29, 4-37, 4-40 pumping mechanism, 4-7, 4-12, 4-37 failures, 4-15 Q Qualification technical personnel, 1-3, 6-3, 6-11 user, 1-4 RAM, 4-5, 4-16, 4-17, 4-18 RAM Protection, 4-16 RESET Touchswitch, 4-7, 4-8, 4-31 REVIEW/CHANGE Touchswitch, 4-8 Receive Butlers, 4-20 Recommended Spare Parts, 8-4 Rectifier, 4-22 Reference Network, 4-32, 4-33, 4-34 Replacement Parts, ordering, 6-3 Resonator Y1, 4-18 ROM, 4-5, 4-17 s Sanitizing the Infuser, 5-5 ‘Screen Display Integrity, 5-8 SELF-TEST status, 4-5, 5-8 Second Clock Source, 4-15, 4-18 Secondary Delivery, 4-3 ‘macro, 4-45 micro, 4-45 Secondary Fluid Inlet Valve, 4-5, 4-37, 4-39 ‘Segment Control, 4-35, 4-36 Self-Test, 4-7, 5-8 Sensor PWA lock diagram, 4-29 description, 4-29 Serial Communication Interface (SCI), 4-18 Set-Up, 4-7 Shipping Instructions, returns, 7-3 SILENCE Touchswitch, 4-8, 4-9 Single Dose, 4-3 Sofware Revision Level Check, 5-8 Source Motor, 4-37 Specifications, 2-3 battery, 2-3 recharge, 2-3 self-discharge, 2-3 casing, 2-3 delivery rate range, 2-3 macro mode, 2-3 1-6 430-03426-002 micro mode, 2-3 dimensions, 2-3 distal air-in-line alarm, 2-4 dose limit range, 2-4 macro mode, 2-4 micro mode, 2-4 environment, 2-3 fuses, 2-3 urse-call alarm, 2-4 occlusion alarm distal, 2-4 proximal, 2-4 operating pressure, 2-4 power, 2-3 weight, 2-3 Springs, 4-41, 4-42 ‘steel leaf, 4-31 ‘Stepper Motors, 4-30, 4-40, 4-41 Strain Gauge, 4-29, 4-31 Stuck Touchswitch, 5-9 Supply Voltage Conversion, 4-16, 4-19 SYSTEM MALFUNCTION Status, 4-12 ‘System Failure, 4-7 ‘System Interconnect Schematic, 8-5 Technical Pertonnel, qualification, 1-3, 6-3, 11 Technical Service Center address, 6-4 telephone number, 6-3 430-03426-002 ABBULL LIFECARE 9000 INFUSION SYS1EM_ Index ‘Threshhold Detectors, 4-32, 4-33, 4-34 Timers, 4-6, 4-20 Timing Control, 4-18 Tools, for part replacement, 6-11 Touchswitch Operation, testing, $-8 ‘Transducer Driver, 4-29, 4-30 ‘Transistors, 4-20 ‘Transmit Buffers, 4-20 ‘Troubleshooting Guide, 6-4 U Unwasonic Transducer Driver, 4-29 Unregulated DC Power Supply, 4-21 User Qualification, 1-4 v Valve Motors, 4-5 ‘Voltage Converter, 4-19 ‘Volume Settings, 4-26 WwW Warm-Star, 4-42 Warnings, 1-3, 5-7, 6-3, 6-11 Warranty, 7-3 ‘Watchdog logic, 4-17 monitor, 4-6, 4-26 pulse source, 4-18 7 ABBOTT LIFECARE S000 INFUSION SYSTEM index (BLANK PAGE) 18 430-03426-002 Technical Service Manual READER COMMENT FORM Please take a moment to comment on this publication. Your comments will help us to produce better manuals. Title of Publication ‘Manual Number Dato How do you use this publication? ‘What is your occupation? © Susy 7 Maintenance What is your overall rating of this © Reference [1] Troubleshooting dao G Instattation [] Operations © Sales Training 1D very good O reir O Goos CO Poor {is the material presented effectively? C0 very poor Cl Weil organized J) Well illustrated How would you compare this manual Gi Clear Gi Technically accurate | with other technical manuals? © Content compiete O Favorably 1D Unfavorably Please answer the following questions in the space below. Be specific. Whenever possible, give page, paragraph and line number references. © Does this manual fulfil your needs? ‘© What did you like about this manual? © Is it easy to use? © What didn't you like about this manual? © What improvements would you suggest? ‘Your name and return address (Please include zip code) © Reply desired?) Yes [No ‘We appreciate your comments about this publication and your suggestions for Improving Ht, Detach or photocopy this sheet and mail to ACCCS, Technical Writing Dept., 1255 Terra Bella Avenue, Mountain View, California, 94043. Do not use this form as an order blank. Contact your Customer Service Representative to order additional copies of this and other publications. -430-09426-002 ABBOTT CRITICAL CARE AND CONTROL SYSTEMS Technical Writing Dept. 1255 Terra Bella Ave. Mountain View, CA 94043 Please fold and staple Technical Service Manual For technical assistance in the U.S, contact: Abbott Laboratories Technical Services Center ‘980 Linda Vista Avenue Mountain View, California 94043, Technical Services Hotline: 1-B00-ABBOTT-3 (1-800-222-6883) followed by [1] [4] [333] For technical assistance in other locations, contact: The LifeCare 5000 infusion System is an electrical instrument. Do not operat: (covers removed). Refer servicing to Abbott-qualified technical personnel. it with the case opened The LifeCare 5000 Infusion System is not suitable for use in @ hyperbaric chamber. Connect only to properly grounded, hospital-grade ac receptacle or appropriate al IMP FROM AC-LINE POWER BEFORE REPLACING FUSES. Do not immerse the Infuser or mechanism in fluids of any kind. Do not sterilize by heat, steam, ETO, or radiation. DANGER: POSSIBLE EXPLOSION HAZARD IF USED IN THE PRESENCE OF FLAMMABLE ANESTHETICS. CAUTION: Federal (USA) law restricts this device to sale by or on the order of » physician or other licensed practitioner. Covered by one or more of the following U.S. Patents: 4,336,800; 4,453,932; 4,552,336. The LifeCare 5000 Infusion System is listed by Underwriter’s Laboretories, inc. UL Listing does not cover administration sets. MEDICAL EQUIPMENT GR e LISTED 873K LR 36804 CSA STANDARD C 22.2 No, 125 Printed in USA RISK CLASS 3 430-03426-002 ABBUIT LIFECAKE 90UU INFUSIUN 9T91Em Technical Service Manual (BLANK PAGE) 430-03426-002

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