Medfusion Model 3000 Series Technical Service Manual Rev B March 2008

Table of Contents

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Table of Contents

Table of Contents I Introduction

1

Important Information

1

Warnings... 1 Cautions... 2

Contents of this manual

3

Authorized use of this manual... 3

About the pump

4

Features and Controls... 4 Keypad closeup... 5

Understanding “Biomed” mode

7

What is biomed?... 7 Authorized biomed access... 7 Biomed software program – major options... 7 Symbols... 8 Glossary of Technical Terms... 9

II Scheduled Maintenance

15

Preventive Maintenance Planning

15

Biomed maintenance tools

15

Using a torque screwdriver... 15 Electrostatic-controlled workstation... 15 Service warnings... 16

Periodic maintenance

17

Installation/quick check-out... 17 Quick check-out test... 17 Cleaning and care... 18 Standard cleaning of Medfusion™ 3000 series pumps.. 18 Cleaning cautions... 18

Mandatory annual maintenance testing

19

General inspection... 19 Power-up test... 19 Calibration verification... 20 Force sensor check... 20 Syringe size sensor check... 20 Plunger position sensor check... 21 Motor drive & occlusion operational test... 21 Flow delivery accuracy test... 22 AC line leakage test... 22 AC line leakage test - Medfusion™ 3500BC... 23 Battery maintenance... 24 Shallow discharge (CPI) record... 24 Battery calibration procedure ... 24 Requirements for battery pack replacement... 25 Collect Separately... 25

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III Theory of Operation

27

Overview of operation

27

Controlling motor functions... 27 Infusion control & safety functions... 27

Pump design description

28

Logic core of Medfusion™ 3000 Series pumps... 28 Main circuit board... 28 Main microprocessor... 28 Watchdog circuit... 29 DC power converter... 29 Real time clock... 29 Graphical display circuit board (LCD)... 29 Keypad... 29 Plunger (driver) travel sensor... 29 Motor rotation sensor... 29 Stepper motor... 29 Syringe flange loaded sensor... 29 Syringe size sensor... 29 Interconnect printed circuit board... 29 AC power input & power supply board... 30 DC power input jack... 30 Speaker... 30 Rechargeable battery pack & battery gauge... 30 Plunger printed circuit board... 30 Plunger force sensor... 30 Plunger Loaded Sensors... 30 Main Board – Schematic Level... 31 Logic Kernel Description... 31 68HC11K4 Main Microprocessor Interface, U19 . . 31 Flash memory, U22... 34 Software upgrade method for programming flash memory... 34 Static random access memory, U17... 34 Serial EEPROM, U2 and U4... 34 Time of day, U8... 34 Infrared transceiver... 34 Analog to digital converter, U13... 35 Digital to analog converter, U20... 35 I/O port expansion, U3, U33... 36 Expansion port # 1 (port1_cs)... 36 Expansion port # 2 (port2_cs)... 37 Power control description... 38 Always on supply, U7 ... 38 Backup super capacitor, C11... 38 Backup audio buzzer, XD1... 38 System reset, U43... 39 Power management, U39... 39 Power OFF state... 39 Power ON state... 39 Watchdog... 39 DC to DC converter... 40 Logic supply, U12... 40 Motor supply, U34... 40 Analog supply, U21... 40 Positive & negative supply, U36... 41 LCD backlight supply, U1... 41 iii

Table of Contents Front panel interface description... 42 LED drive circuit, Q26, Q27, Q40, Q33 - Q37... 42 Keypad matrix interface... 42 Power switch interface... 42 Graphic display interface description... 43 Data output to LCD, U32 / data input from LCD, U6... 43 LCD contrast... 43 LCD backlight... 43 Motor drive description... 44 Coil A & B PWM current references... 44 Motor current regulators, U26, U35... 44 Motor current detector, U40... 44 Sensors interface description... 45 Motor speed detection... 45 Syringe sensing description... 45 Syringe size sensing... 45 Syringe flange (ear) sensing... 45 Plunger position sensing description... 46 Speaker drive description... 46 Speaker control... 46 Speaker test... 47 Plunger board – schematic level... 47 Force preamplifier function... 47 Force sensing interface description... 47 Plunger flipper sensor function... 48 Interconnect board – schematic level... 49 AC power detection description... 49 External DC power conditioning / detection description... 50 Infrared serial data port description... 50 Battery management description... 51 Battery gauge interface... 51 Battery charger... 51 Charge detector... 52 Battery switchover... 52 Battery board – schematic level... 52 Battery gauge function... 52 Severely depleted battery monitor... 52

IV Troubleshooting

53

Problem solving alarms / alerts

53

Types of alarms / alerts... 53 Alarm messages & priorities... 54 System Advisory Alarms... 60 System Failure Alarms... 61 General troubleshooting... 65

Smiths Medical service and support

67

Using Smiths Medical service assistance... 67 Returning a pump for repair... 67

Using Biomed for troubleshooting

68

Accessing Biomed... 68 Biomed > Calibration . ... 69 Biomed > Diagnostics (screen 1 of 2)... 69 Audio Test... 69 iv

Display Test... 69 Indicator Test... 69 Keypad Test... 70 Monitor Analog Sensors... 70 Monitor Digital Sensors... 70 Monitor Battery Status... 70 Drive Train Test... 70 Biomed > Diagnostics (screen 2 of 2)... 70 Motor Drive Test... 71 Monitor a2d Selftest... 71 Monitor 6811 a2d Group1... 71 Monitor 6811 A2D Group2... 71 Biomed > Utilities... 71 Set/View Last [Next] PM Date... 71 Set Time/Date (Current)... 72 View Alarm History... 72 View Infusion History... 72 View Software CRCs & View Software Versions... 72 View Service Data... 72 View EEPROM Size [available only on Medfusion™ 3500 pumps version 4 and higher)... 72 Biomed > Update Firmware [not available on Medfusion™ 3500 pumps, version 4 and higher] ... 73 Set Language [Not available on Medfusion™ 3010 and 3010a]... 73

V Parts Replacement

75

Maintenance warnings/cautions

75

Service warnings . ... 75 Service cautions ... 75

Opening & closing the pump housing 76 Tools needed... 76 Opening the pump housing... 76 Closing the pump housing... 76

Battery pack

77

Tools needed... 77 Removing the battery pack... 77 Replacing the battery pack... 77 Verifying battery function after new battery replacement... 77

Interconnect board

78

Tools needed... 78 Removing the interconnect board... 78 Replacing the interconnect board... 78 Verify interconnect board function... 78

Speaker

78

Tools Needed... 78 Speaker removal... 78 Speaker replacement... 78 Verifying speaker function ... 78

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Table of Contents AC power supply

79

Tools needed... 79 Removing AC power supply... 79 Replacing the AC power supply... 79 Verify AC power supply function... 79

AC input assembly

79

Tools Needed... 79 Removing AC input module assembly... 79 Replacing AC input module assembly... 79 Verifying AC input assembly module function... 80

Bottom housing plastic

80

Tools Needed... 80 Removing the bottom housing... 80 Replacing the bottom housing... 80

Main board

81

Tools needed... 81 Removing the main board... 81 Replacing the main board... 81

Drive train assembly

82

Tools Needed... 82 Motor unit (motor, worm, worm gear)... 82 Removal... 82 Replacement... 82 Reassemble motor unit... 82 Position potentiometer... 83 Removal... 83 Replacement... 83

Clutch assembly

84

Tools needed... 84 Leadscrew... 84 Removal... 84 Replacement... 84 Clutch or clutch cam... 84 Tools needed... 84 Removal... 85 Replacement... 85 Plunger cable... 85 Removal... 85 Replacement... 85

LCD and backlight

86

Tools Needed... 86 Removing LCD and/or backlight assembly... 86 Replacing the LCD and/or backlight assembly... 86 Verify LCD & backlight assembly function... 87

Keypad

87

Tools needed... 87 Removing the keypad... 87 Replacing the keypad... 88

Syringe barrel clamp assembly

88

Tools Needed... 88 40-5648-51B

Barrel clamp head... 88 Removal... 88 Replacement... 88 Verify Function... 88 Barrel clamp body assembly ... 88 Removal... 88 Replacement... 89

Ear clip, handle & guide

89

Tools Needed... 89 Ear clip ... 89 Removal... 89 Replacement... 89 Ear clip optical sensor . ... 89 Removal... 89 Replacement... 90 Handle... 90 Removal... 90 Replacement... 90 Tubing guide... 90 Removal... 90 Replacement... 91

Plunger case assembly

91

Tools needed... 91 Plunger lever... 91 Removal... 91 Replacement... 91 Plunger case disassembly... 91 Disassembly... 91 Reassembly... 91 Cam gear and timing plate... 92 Removal... 92 Replacement... 92 Flipper and flipper gear... 92 Removal... 92 Replacement... 92 Plunger board... 92 Additional tools needed... 92 Removal... 92 Replacement... 93 Force sensor... 93 Additional tools needed... 93 Removal... 93 Replacement... 93 Left plunger case... 94 Additional tools needed... 94 Removal... 94 Replacement... 94

VI Calibration and Adjustment

95

Using Biomed > Calibration

95

Biomed > Calibration . ... 95 Calibrate (Syringe) size and position... 97 Performing both size & position calibration... 97 Calibrate force sensor... 100 Calibrate pressure sensor (future option)... 102 v

Table of Contents Calibrate plunger position... 102 Calibrate syringe size sensor... 104 Adjust contrast (voltage) setting... 105 View calibration data... 106 Save changes and exit... 107 Exit calibration without saving changes... 107

Retest guidelines

108

VII Schematics & PCB Assemblies 111 System layout

111

Main board schematics

112

Main board / logic kernel... 112 Main Board / Power Control Logic Core... 116 Main Board / DC-DC Converter... 118 Main Board / Keypad Interface... 120 Main Board / Graphic Display Interface... 123 Main Board / Motor Drive... 124 Main Board / Syringe Sensing... 125 Main Board / Position Sensing... 126 Main Board / Force Sensing... 127 Main Board / Pressure Sensing... 128 Main Board / Speaker Drive... 129 Main Board / ACU-ICE Socket... 130 Main Board Assembly Drawing – Top Side... 131 Main Board Assembly Drawing – Bottom Side... 132 Main Board Assembly – Parts list ... 133

Plunger Board Schematic

Barrel clamp assembly... 161 Barrel clamp assembly – parts list... 162 Drive train assembly... 163 Drive train assembly – parts list... 164 Clutch assembly... 165

Accessories – parts list

166

Poleclamp assembly... 166 Poleclamp parts... 167 Rotating poleclamp parts ... 167 Miscellaneous parts... 167 Calibration & repair – parts list... 168 Medfusion™ 3000 series calibration kit... 168 Other tools & equipment required to service Medfusion™ 3000 series pumps... 168

Notes

169

139

Plunger Board / Force Preamplifier... 139 Plunger Board / Flipper Sensor... 140 Plunger Board Assembly Drawing ... 141 Plunger Board Assembly – Parts list . ... 142

Battery Gauge Schematic

143

Interconnect Board Schematic

144

Interconnect Board / Power Control... 144 Interconnect Board / Battery Management... 145 Interconnect Board / Infrared Serial Communications.. 146 Interconnect Board Assembly Drawing ... 147 Interconnect board assembly – parts list . ... 148

VIII Assembly Drawings & Parts Lists 151 Assembly drawings

151

Medfusion™ 3000 series main pump assembly... 152 Medfusion™ 3000 series main pump assembly – parts list... 153 Case bottom assembly... 154 Case bottom assembly – parts list... 155 Case top assembly w/plunger... 156 Case top assembly w/plunger – parts list... 157 Case top assembly without plunger... 158 Case top assembly without plunger – parts list... 159 vi

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Introduction

Important Information WARNING: Read this entire manual before attempting and service or repair on a Medfusion™ 3000 Series Syringe Infusion Pump. Failure to follow the instructions and important information contained in this manual, or improper/inadequate testing, service, repair or troubleshooting can lead to death or serious injury. Warnings, cautions and other important safety information can be found in this section, and throughout the manual (they are contained within lines at top and bottom). The term WARNING is used to indicate a hazard that has the potential to cause injury or death to a technician, patient or user. The term CAUTION is used to indicate a hazard that has the potential to cause damage to the product or other property.

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Note: This manual supersedes all previous revisions.

Warnings •

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Attempts to repair or maintain a pump by personnel without proper qualifications or training may create a major hazard which could result in serious injury or death to the patient or the user. Use only approved parts and procedures for repair and maintenance of this pump. Failure to follow this manual may create a major hazard which could result in serious injury or death to the patient or the user. Repair Pump in ESD Controlled Work Area: The pump case should only be opened at a workstation with Electrostatic controls, including a grounded mat and wrist-strap. Pump Maintenance: Only trained biomedical service personnel may service this pump. Service personnel should disconnect the AC power cord before servicing the pump. AC Power: The only means of removing AC power is to disconnect the AC power cord. While the AC power cord is attached to the pump and plugged into an AC outlet, live mains voltage is present within the pump. Manufacturer Recommended Maintenance: Always maintain this pump following manufacturer recommended instructions in this Service Manual. An improperly maintained pump may cause serious injury to a patient or user. Safety Class II, Type CF Medical Equipment: The

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•

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pump is listed as Safety Class II, Type CF equipment. Protection against electrical shock does not rely only upon basic insulation, but instead relies on double or reinforced insulation. As such, this equipment does not utilize a third wire ground (earth ground). Therefore, when doing line leakage test it is not necessary to measure leakage in both the open ground and closed ground setting. Nor is it necessary to perform a ground resistance test. Safety Class II with functional earth, Type CF Medical Equipment: The pump is listed as Safety Class II with functional earth, Type CF equipment. Protection against electrical shock does not rely only upon basic insulation, but instead relies on double or reinforced insulation. As such, this equipment utilizes a third wire ground (earth ground) lead of the power cord as earth return for electromagnetic energy and does not serve as a safety function. Therefore it is neither possible nor necessary to perform a ground resistance test. Battery Replacement: Observe ESD handling precautions when replacing the battery. Replace battery only with same Smiths Medical part/model number. Recycle batteries in compliance with applicable local regulations. Collect Separately. There are potential health hazards associated with improper disposal of batteries, electronics, and contaminated (used) infusion sets and syringes. Dispose of used batteries, infusion sets, syringes, and other used accessories, or a pump that has reached the end of its useful life, in an environmentally safe manner, and according to any regulations that may apply. Clean the Pump: Always clean the pump thoroughly before performing maintenance on it. This is recommended by the United States Occupational Safety & Health Administration (OSHA) as a protection from potential biohazard. External DC Power: Any power source connected to the external DC jack must be IEC 60601-1 certified for medical equipment: Type CF, Safety Class II. Connecting external power to the pump creates a medical system; therefore, the user is responsible for compliance with IEC 60601-1 standards. Refer all questions to Smiths Medical Technical Service department. 1

Introduction •

While servicing the Medfusion™ 3000 Series infusion pump you should wear safety glasses as it contains springs and other small parts which may be a hazard.

Cautions •

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•

•

2

Avoid Organic Solvents: Never use organic solvents (e.g., acetone), quarternary ammonia compounds, strong acids or strong bases to clean any portion of the pump. Not Waterproof: The Medfusion™ 3000 Series is “spray resistant” but not “water proof ”. Never spray cleaning or other fluids directly into openings on the bottom of the pump. Never immerse the pump in water or other fluids. Avoid Spray Oils: Never use light spray oils (e.g., WD40™) to clean or lubricate pump. These chemicals can damage the plastic of the pump. Never Autoclave or Gas Sterilize: Never sterilize the pump in a steam autoclave or gas. Using an autoclave or gas sterilization can seriously damage the Medfusion™ 3000 Series pump and void the warranty. Disconnect AC Mains & External DC Power: Always disconnect the pump from AC Mains and from External DC power before disassembling the pump for maintenance. Handle Batteries with Care: Always handle the pump’s battery pack with care. Don’t Over-tighten Screws: Never over-tighten any screws in the pump. Unless otherwise specified, you should torque all screws to 60 in- oz (0.42 Nm). Battery Disposal: Always dispose of exhausted NiMH batteries in compliance with all pertinent local, state, national, and international regulations. If unsure of correct methods for compliance, you may return battery packs to Smiths Medical for recycling. Keypad is NOT Flexible: Whenever handling the keypad, always ensure it remains flat. Bending the keypad can damage keys or break LED contacts.

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Introduction

Contents of this manual This is the technical service manual for Medfusion™ 3000 Series Syringe Infusion Pumps manufactured by Smiths Medical MD, Inc. Its purpose is to provide the technical information necessary for maintenance, troubleshooting and repair of these pumps. This manual does not contain information on operating or configuring various models within the Medfusion™ 3000 Series. Such information is found in manuals specific to each individual model, (e.g., Medfusion™ 3500 Operations Manual and Medfusion 3500 Configuration Manual). The sections of this manual are: Introduction •

•

Overview of contents and purpose of this manual.

Authorized use of this manual This manual is only intended for use by trained biomedical technicians who are authorized by their institution to perform maintenance and repair of critical medical devices. WARNINGS: • Attempts to repair or maintain a pump by personnel without proper qualifications or training may create a major hazard which could result in serious injury or death to the patient or the user. • Use only approved parts and procedures for repair and maintenance of this pump. Failure to follow this manual may create a major hazard which could result in serious injury or death to the patient or the user.

Scheduled Maintenance •

List of tests for required annual maintenance, and the procedure for completing each test. Theory of Operations •

Descriptions of the systems which control the operation of Medfusion™ 3000 Series pump. Troubleshooting •

Tables of failure messages together with problem descriptions and possible solutions. Also includes an overview of Biomed Diagnostics & Utilities. Parts Replacement •

Detailed procedures for removal and replacement of parts of Medfusion™ 3000 Series pump. Calibration •

Detailed procedures for calibration of Medfusion™ 3000 Series pump. Schematics and PCB Assemblies •

Contains board level schematics & PCB assembly drawings. Assembly Drawings and Parts Lists •

Contains mechanical assembly parts lists and replacement parts lists for repairs. Appendices •

Contains technical information relevant to Medfusion™ 3000 Series pumps.

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3

Introduction

About the pump Features and Controls Following are several illustrations showing the various controls, connectors and features of the Medfusion™ 3000 Series pump.

C

D

E

F

H

I

G*

B G*

1) 1 LCD Display: All pump operating and status information appears on the LCD display. The upper portion of the display provides instructions and alarm information. The middle portion of the display shows the current status of the operation in progress or the state of the data entry for pump programming. The lower portion of the display corresponds with the 4 ‘softkeys’ (their function changes depending on where you are in a pump program) on the keypad. 2 Tubing Holders: Thread infusion set tubing between holders to prevent kinking at syringe tip. 3 Carrying Handle 4 Syringe Barrel Clamp: The clamp holds the syringe barrel securely in place. 5 Syringe Barrel Flange Clip: When loading a syringe, slide the syringe flange into the clip.

4

J 6 Syringe Plunger Holders: Holds the syringe plunger securely in place. 7 Syringe Plunger Driver: Once loaded and delivery is started, the driver pushes the syringe plunger forward at a controlled, precise rate to deliver fluid. 8 Syringe Plunger Release Lever: Squeeze the release lever down to allow placement of the syringe plunger onto the holder during loading, or to remove it during unloading. 9 AC Power Connection Port: Plug the AC power cord into connection socket to allow pump to operate on AC (mains) power. 10 Keypad: See Keypad closeup for identification of the individual keypad buttons and what they are used for.

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Introduction

1@ 1#

1!

11 Optional Poleclamp Mount: If desired, attach the optional poleclamp here. 12 External DC Power Input Jack: Plug approved external DC power supply into jack. 13 RS232 Connection Port: Plug RS232 connector into the port to allow upload of data from and download of data to a pump from a PC. This port is also used to load the pump software.

Keypad closeup

BOLUS

7

POWER

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START

3

STOP

1

2

3

4

5

6

7

8

9

0

.

BACK

5

Introduction Button Alarm Silence (í) Power (ë) Menu buttons Back (â) Numbers & Decimal Stop (á) Start (É) Bolus (è) Indicator

ò - Alarm ô - AC Line õ - Battery ö - Lock

úù Infusing

When pump is paused Silences audible alarm. Allows operator to switch the display backlight from bright to dim or dim to bright. Push and hold to turn pump Off.

Set number values or select options. N/A

When pump is delivering Silences audible alarm. Allows operator to switch the display backlight from bright to dim or dim to bright. Push and release, then push and hold to turn pump Off. Function is defined on the display. Reverts to a previous step or level if adjusting settings. Set number values or select options. Stops delivery (pump remains On).

Starts delivery.

N/A

Begins priming after confirmation.

Begins delivery of programmed bolus after confirmation.

Function is defined on the display. Reverts to a previous step or level.

What it means The Alarm indicators (yellow or red) are on whenever the pump is in an alarm condition. The specific details of each alarm are covered in the Troubleshooting section later in this manual. The AC Line indicator (green) is On whenever the pump is connected to “mains” line power. It is Off when the pump is not connected to an active AC line. The Battery indicator (green) blinks On & Off whenever the pump is operating on internal battery power, and remains On when the battery is charging. The Lock indicator tells you the pump has been locked into its current operational mode. While this indicator is lighted, the keypad is locked and no changes can be made to settings. Attempting to stop or change an infusion while locked will result in an alarm and an advisory message. The Infusing indicators are 3 green lights, which illuminate in sequence right to left when the pump is delivering fluid (the 4th LED indicator on the far left - on the tubing - is not used at this time). During intermittent delivery mode, a single Infusing indicator lights during the time between infusions. When the pump is Off or stopped, the Infusing indicator is not lit.

6

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Introduction

Understanding “Biomed” mode Periodic maintenance and troubleshooting on Medfusion™ 3000 Series infusion pumps are aided by use of the “Biomed” software interface.

What is biomed? The Biomed feature is the special utility intended for use only by trained biomedical service technicians. • • • • • • • •

Biomed has its own security access code. Biomed is for calibration of the pump’s sensors. Biomed is for diagnosis of digital and analog sensors contained in the pump. Biomed allows access to infusion history log and alarm history log stored in the pump. Biomed is for testing of the pump’s drive systems. Biomed is for monitoring the status of the pump battery. Biomed is for setting the pump’s last (V3) or next (V4) preventive maintenance date. Biomed is for setting the time and date.

Authorized biomed access Never use Biomed features unless you are trained in maintenance on the Medfusion™ 3000 Series pumps and have been authorized by your facility to use the Biomed program.

Biomed software program – major options The Biomed utility has four major modes on its Select the Mode screen. These are: 1. Calibration to check calibration values, re-calibrate sensors or set display contrast. 2. Diagnostics to examine analog and digital signal readings, or test the speaker, motor or display function. 3. Utilities to review alarm history, to review infusion history, to set time and date, to update periodic maintenance timestamp.

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4. Update Firmware to reprogram the pump’s software version through the serial interface (only available with service upgrade software diskette and instructions on certain models). The following is an outline of the Biomed software: Calibration

Diagnostics

• cal size and position • cal force sensor • cal pressure sensor • cal plunger position • cal syringe size sensor • adjust contrast • view calibration data

• Audio test • Display test • Indicator test • Keypad test • Monitor analog sensors • Monitor digital sensors • save changes and exit • Monitor battery status • Drive Train Test (V4) • Motor drive test • Monitor a2d self test • Monitor 6811 a2d group1 • Monitor 6811 a2d group2 • Force sensor test (V3) • Pressure sensor test (V3) Utilities Update Firmware • set/view last pm date (Special use only for OR set/view next pm software update - Not date available on all pumps) Set Language • set time/date • view alarm history (Medfusion™ 3500 Only) • view infusion history • view software crcs • view software versions • view service data • view EEPROM size (V4)

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Introduction

Symbols The following is a list of symbols which may appear on the pump (or on it’s labeling or accessories), as well as certain technical terms, along with an explanation of what they mean. > g

J K

J 6 <

Z

9 7 8 @

5

ó P _ i

8

Serial number Attention, See instructions for use Type CF equipment (protection from electric shock) Equipment in which protection against electric shock relies on double or reinforced insulation instead of basic insulation. Accessible metal components of pump enclosure use this higher level of insulation instead of safety grounding. Medfusion™ 3500BC pumps: The earth ground of the power cord serves the purpose of providing a “functional earth” return for electromagnetic energy. Date of manufacture CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Catalog number Collect Separately Latex free Do not reuse Use by Authorized representative in the European Community Australian representative Indicates the product was designed and manufactured in accordance with applicable standards/guidelines and may be sold in the EU (European Union). UL Mark for Canada and the United States. Indicates the product was manufactured in accordance with the requirements of UL (Underwriter’s Laboratory). Temperature limitation

of connectors and other areas identiÜ Pins fied with this ESD Warning symbol should

Ö Ñ V~ F2

IPX3

not be touched. Connections should only be made when ESD precautionary measures are used. External DC jack connection. Tip (negative sign) is for power ground and ring (positive sign) is for positive power connection. (See warning that follows.) Symbol for infrared serial communications port on pump. Operating voltage range for alternating current (i.e. AC or mains) power source Medfusion™ 3500BC pumps: The designation “F2” indicated on the label, which is located on the AC input module connector assembly for the pump, is indicating a non-replaceable fuse that is part of the input module assembly. The fuse is located on the neutral side of the AC line. Medfusion™ 3500BC pumps: The “ground” symbol indicated on the label, which is located on the AC input module connector assembly for the pump, is indicating that the earth ground connection is providing a functional ground and not a safety ground. Equipment that is ingress protected from fluid spraying at vertical angle from above, and from angles to 60° on either side of vertical

Infusion Class 4 An infusion pump that combines the functions of continuous infusion flow, intermittent flow, and discrete bolus delivery Infusion Class 5 An infusion pump that functions as a profile pump, providing a programmed sequence of delivery rates

Humidity limitation Atmospheric pressure limitation

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Introduction

Glossary of Technical Terms This is a glossary of technical terms relating to the Medfusion™ 3000 Series pumps.

Term

Definition

AC Line Leakage Test

The pump is listed as Safety Class II, Type CF equipment (Medfusion™ 3500BC pumps are listed as Safety Class II with functional earth, type CF equipment). Protection against electrical shock does not rely only upon basic insulation, but instead relies on double or reinforced insulation. As such, this equipment does not use a third wire ground (earth ground). Therefore, when doing line leakage test it is not necessary to measure leakage in both the open ground and closed ground setting. Nor is it necessary or relevant to perform a ground resistance test. Medfusion™ 3500BC: The third wire ground (earth ground) serves a functional and not a safety purpose. Therefore, it is neither necessary nor relevant to perform a ground resistance test. Protection against leakage current is the concern for any device (be it Class I or Class II) deriving power from AC mains. Leakage current is what flows from mains side to device component(s) that is conductive and accessible by the user or patient. Safety grounding of exposed metal does not protect the user from leakage current. Safety grounding causes a circuit breaker or fuse to open should a short occur between wall AC side and grounded metal.

Alarm History Alarm Message Backup Audio Buzzer

Backup Super Capacitor Battery Gauge

The Medfusion™ 3000 Series pump achieves protection by double-isolating secondary power and exposed metal from AC power. The Medfusion™ 3000 pump satisfies the UL requirement that 4000 volts can be applied between AC side and exposed metal without causing significant current to flow. See “view alarm history”. The onscreen text which appears to indicate situations or circumstances requiring user attention. The backup audio buzzer provides a means of generating an alarm during: • instrument power loss (while the instrument was on) • malfunction of the main microprocessor • or failure of the primary speaker. The backup audio buzzer activates during Watchdog Alarm, anytime there is a malfunction of the main microprocessor. During power-up self-tests, the buzzer function is verified by briefly allowing the watchdog alarm to activate. A one (1) Farad Super Capacitor is part of the power control design to provide backup power to the audio buzzer in the loss of the primary power source. The gauge circuits monitor direction and magnitude of current flowing through the battery. • The battery current is sensed by the gauge. • The gauge then computes capacity. To control charging the battery, the gauge uses battery temperature and battery voltage. The gauge changes to trickle charge in the event the battery temperature exceeds 50°C or if the battery voltage is lower than 5.7 volts.

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9

Introduction Battery Parameters

There are two battery parameters requiring periodic inspection to maintain good battery performance. They can be accessed by selecting Biomed > Diagnostics > Monitor Battery Status. LMD (Last Measured Discharge) − This the learned capacity of the battery by the gauge following a calibration cycle. Replace the battery when this is < 1600 mA-hours. • CPI (Capacity Inaccurate) − This is the number of shallow discharge cycles since the last calibration. Always recalibrate the battery when CPI is > 80 Hex. Refer to the Battery Calibration section of this manual. A set of functions for calibration/adjustment of the sensors within the Medfusion™ 3000 Series pump. •

Biomed Calibration

Biomed Diagnostics

Biomed Utilities

Steps and processes for using Biomed > Calibration functions are found in the Adjustment & Calibration section. A set of functions which allow the detailed examination of the pump’s systems, sensors, indicators, and controls. Steps for using Biomed > Diagnostics functions are found in the Scheduled Maintenance and Troubleshooting sections. The set of Biomed > Utilities contain a mixture of adjustment and troubleshooting options. These are:

Set / View Last PM Date (or Set / View Next PM Date) − Used to view and set the Preventive Maintenance (PM) date. • Set Time / Date − Used to set date and time for built-in real time system clock. • View Alarm History − Used to view alarm and alert history stored in pump memory. This is a troubleshooting feature. You may page backward and forward through stored alarms in order to identify possible malfunction patterns. • View Infusion History − Used to view programming and infusion information stored in pump memory. This can be a troubleshooting feature. You may page backward and forward through stored record of infusion types in order to identify how the pump has been used. • View Software CRCs − For “factory use” only. Allows view of CRCs for each code bank. • View Software Versions − Used to view both bootbank version and main version of software installed within the pump. Configuration Cloning Two pumps can communicate through their built-in infrared serial communications interface, with one teaching and the other learning, to copy pump configuration settings, and libraries. CPI (Capacity Inaccurate) This is the number of shallow discharge cycles since the last calibration. Always recalibrate the battery when CPI is > 80 Hex. Refer to the Battery Calibration section of this manual. Depleted Battery Monitor The circuitry which measures present battery charge status against stored battery capacity data to determine a “depletion” situation. EN 475 Alarms The EN 475 alarms use tones designed for use by customers following European standards. These generate High, Medium & Low Priority Alarms. •

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Introduction External Power Detector Flash Memory High Priority Alarms

Infrared Serial Data Port Infusion Class 4 Infusion Class 5 Interconnect Board IPX3 Keypad Test LCD LCD Backlight Limit Priority Alarms

Circuitry which determines when and if external power (whether AC or DC) has been or is connected to the pump. The pump uses flash memory, which is re-programmable through the infrared (IR) port and a remote computer. A high priority alarm results from either any condition which halts an ongoing infusion, or any pump system fault which affects infusion. If the front panel controls are locked when a high priority alarm occurs, the pump controls unlock. High Priority alarms are signaled by a flashing red indicator and an audible signal. Press í to pause the audible alarm for the preset alarm silence period. The infrared serial port interfaces directly with the main microprocessor’s asynchronous serial communication pins. The infrared port supports short transmission distances of 2” or less and a maximum baud rate of 9600. An infusion pump which combines the functions of continuous infusion flow, intermittent flow, and discrete bolus delivery. An infusion pump which functions as a profile pump, providing a programmed sequence of delivery rates. The interconnect printed circuit board interfaces to an intelligent NiMH Battery (or NiCad on older model pumps), the system speaker, the internal DC supply and supply conditioning for an external DC supply and the main PCB. Equipment which is ingress protected from fluid spraying at a vertical angle from above, and from angles to 60° on either side of vertical. Verifies individual function of each key on the keypad. Nonfunctioning keys indicate need for keypad replacement. Liquid Crystal Display. The LED fiber optic light source which illuminates the LCD display. A limit priority alarm is generated whenever a preset minimum or maximum limit has been violated. For example: when programming an infusion there are minimum and maximum limits preset rates assigned to syringes by size & manufacturer. •

LMD (Last Measured Discharge) Low Priority Alarms

The limit priority alarms sound a tone and display an advisory message onscreen for 3 seconds. To re-display the message press í. This the learned capacity of the battery by the gauge following a calibration cycle. Replace the battery when this is < 1600 mA-hours. A low priority alarm indicates any condition not requiring immediate operator intervention. Low Priority alarms are announced with a continuous yellow indicator and an intermittent audible signal.

Medium Priority Alarms

Pressing í permanently silences this alarm. If the front panel controls are locked when a low priority alarm occurs, the pump controls do not unlock. A medium priority alarm indicates any condition requiring operator intervention but does not halt infusion. Medium Priority alarms are signaled with a flashing yellow indicator and an audible signal. Pressing í will silence the audible alarm for the programmed alarm silence period. • •

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If the front panel controls are locked when a medium priority alarm occurs, the pump controls do not unlock. 11

Introduction Motor Rotation Sensor A optical sensor on the main board senses the movement of the motor worm shaft. “Neglected Pump” or User The “Neglected Pump” or user call back alarm is a low priority alert which simply Call Back reminds you to finish what you started. Once you begin programming any infusion, the pump expects you to continue until programming is complete.

Occlusion Plunger Printed Circuit Board Safety Class II, Type CF Equipment Serial EEPROM

If you leave the pump paused too long (30 seconds) on any data entry screen, then the pump begins sounding a low priority alert. The blockage of the infusion line during delivery. Here, the pump detects an occlusion by sensing excessive force on the syringe plunger driver. The plunger PCB provides pre-amplification of the force sensor output to the Main board, and contains two photo-interrupters with supporting circuitry for sensing each plunger flipper. See “AC Line Leakage Test”.

A non-volatile storage device (electrically-erasable programmable read-only memory) which is used on the main board to store calibration, configuration, and infusion history. Set / View Last (Next) PM This allows viewing the last (or Next on V4 pumps) recorded preventive mainteDate nance date. This is where you also set the date when completing annual preventive maintenance. Stepper Motor A sequentially stepping motor used to drive the plunger head of the pump. System Failure A high priority alarm indicating that the pump self-tests have detected a failure in pump operation. Primary Speaker The main speaker located in the bottom housing of the pump. All normal alarm/ alert tones are generated through this speaker. Update Firmware The firmware is the software installed in Medfusion™ 3000 Series pumps v3 or lower, and which is used to operate the pumps. The software may only be updated with a software kit provided by Smiths Medical. The Biomed > Update Firmware option is the utility provided for reinstalling software used to operate pumps. This can be used to upgrade to a newer version of system software. (Only available on pumps with the V3 software combined with the V1.6 boot loader provides this option.)

View Alarm History View Infusion History View Software CRCs View Software Versions

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Note: Instructions for updating pump operational software are not included in this technical service manual. Instead, they are part of individual software upgrade kit. This is a troubleshooting feature. In Biomed > Utilities, you may page backward and forward through the stored alarms in order to identify possible malfunctions. This is a troubleshooting feature. In Biomed > Utilities, you may page backward and forward through the stored record of infusions in order to identify how the pump has been used. The history will contain roughly 50 events. For “factory use” only. This is where you identify both the bootbank version and the main version of the operational software installed in the Medfusion™ 3000 Series pump. (Pumps with V4.1.5 software also shows the build number.)

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Introduction Watchdog Circuit

While in the power on state, the auxiliary controller prevents the watchdog Alarm State from occurring by maintaining the AC signal, WATCHDOG_STRB. •

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The main microprocessor periodically issues the AC signal, PET_WATCHDOG.

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Introduction

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