Medfusion Model 4000 Series Technical Service Manual Jan 2012

Table of Contents Technical Assistance The issue date of this manual is included on the back cover. If your manual is a year or more old, contact Smiths Medical to see if a newer manual is available. If you have comments or questions concerning the operation of the Medfusion® Syringe Infusion Pump Model 4000 (Medfusion® Model 4000 pump), please call the appropriate number given below. When calling, please specify your pump’s software version. This information is located on the start-up screen. Smiths Medical ASD, Inc. 1265 Grey Fox Road St. Paul, MN 55112 USA 1 800.258.5361 (USA) +1 214.618.0218 www.smiths-medical.com A printed copy of this manual is available upon request. IMPORTANT: When a pump is returned to the Smiths Medical Service Center for repair, the pump is defaulted to wired network communication, and the Medfusion™ Standard Configuration is installed on the pump. This enables the Service Center to access all of the pump’s internal service/biomed functions during the repair process. Once the pump is returned, the pump will need to be set up for the facility’s network and custom Configuration will need to be re-installed on the pump prior to it’s return to use.

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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 Network Communication

15

PharmGuard® Toolbox 2 Communication

15

Teach Configuration... 15 Create Package... 16 Update Pumps ... 16

Updates via DL4000

16

III Telnet Commands

17

Accessing Telnet

17

1. Enable the pump for External Commands... 17 2. Start Telnet... 17 3. Connect to the pump... 17 Terminology... 18

Telnet commands

19

ifconfig... 20 Usage... 20 Constraints... 20 Notes... 20 iwconfig... 20 Usage... 20 Constraints... 21 Notes... 21 mds... 21 Usage... 21 Constraints... 22 Notes... 22 telnet_cfg... 22 Usage... 22 Constraints... 22

Notes... 22 ping... 22 Usage... 22 hostname... 22 Usage... 22 Constraints... 22 Notes... 22 asset... 23 Usage... 23 Constraints... 23 Notes... 23 factory... 23 Usage... 23 network_stats... 23 Usage... 23 ls... 23 Usage... 23 cat... 23 Usage... 23 flash_coldfire... 23 Usage... 23 battery... 24 Usage... 24 Constraints... 24 clear_history... 24 Usage... 24 time_cfg... 24 Usage... 24 Constraints... 25 Notes... 25 flash_head_app... 26 Usage... 26 head_config... 26 Usage... 26

IV Scheduled Maintenance

27

Preventive Maintenance Planning

27

Biomed maintenance tools

27

Using a torque screwdriver... 27 Electrostatic-controlled workstation... 27 Service warnings... 28

Periodic maintenance

29

Installation/quick check-out... 29 Quick check-out test... 29 Cleaning and care... 30 Standard cleaning of Medfusion® Model 4000 pumps... 30 Cleaning cautions... 30

Mandatory annual maintenance testing

31

General inspection... 31 Power-up test... 31 Calibration verification... 32 Force sensor check... 32 iii

Table of Contents Small syringe size sensor check... 32 Large syringe size sensor check... 33 Plunger travel test... 33 Drive train test... 33 Motor drive & occlusion operational test... 34 Flow delivery accuracy test... 34 AC line leakage test... 35 Battery maintenance... 35 Checking status of battery pack... 36 Requirements for battery pack replacement... 36 Collect Separately... 36 Check LAN/Wireless Settings... 37 Wired LAN settings:... 37 Wireless Settings... 37

V Theory of Operation

39

Overview of operation

39

Controlling motor functions... 39 Infusion control & safety functions... 39

Pump design description

40

Logic core of Medfusion® Model 4000 pump... 40 Main circuit board... 40 Main microprocessor... 40 Watchdog circuit... 41 DC power converter... 41 Real time clock... 41 Graphical display circuit board (LCD)... 41 Keypad... 41 Plunger (driver) travel sensor... 41 Motor rotation sensor... 41 Stepper motor... 41 Syringe flange loaded sensor... 41 Syringe size sensor... 41 Interconnect printed circuit board (PCB)... 41 AC power module... 42 Speaker... 42 Rechargeable battery pack & battery gauge... 42 Plunger printed circuit board (PCB)... 42 Plunger force sensor... 42 Plunger Loaded Sensors... 42 Sensors interface description... 42 Motor speed detection... 42 Syringe sensing description... 42 Syringe size sensing... 42 Syringe flange (ear) sensing... 42 Plunger position sensing description... 43 Speaker drive description... 43 Speaker test... 43 Plunger board (PCB)... 43 Force preamplifier function... 43 Force sensing interface description... 43 Plunger flipper sensor function... 43 Interconnect board (PCB)... 43 AC power detection description... 43 Ethernet data ports description... 43 Battery pack / charger description... 43 iv

Severely depleted battery monitor... 44

VI Troubleshooting

45

Problem solving alarms / alerts

45

Types of alarms / alerts... 45 Alarm messages & priorities... 47 System Advisory Alarms... 50 System Failure Alarms... 52 General troubleshooting... 57

Smiths Medical service and support

60

Using Smiths Medical service assistance... 60 Returning a pump for repair... 61

Using Biomed for troubleshooting

62

Accessing Biomed... 62 Biomed > Calibration ... 62 Biomed > Diagnostics (screen 1 of 2)... 63 Audio Test... 63 Display Test... 63 Indicator Test... 63 Keypad Test... 63 Monitor Analog Sensors... 63 Monitor Digital Sensors... 63 Monitor Battery Status... 64 Drive Train Test... 64 Biomed > Diagnostics (screen 2 of 2)... 64 Motor Drive Test... 64 Monitor a2d Selftest... 64 Monitor 6811 a2d Group1... 64 Monitor 6811 A2D Group2... 65 Biomed > Utilities... 65 Set/View Next PM Date... 65 View Time/Date (Current)... 65 View Alarm History... 65 View Infusion History... 65 View Software CRCs & View Software Versions... 66 View Service Data... 66 View EEPROM Size... 66 Biomed > Set Language... 66 Biomed > System Update Status ... 66 Biomed > Network Settings... 66 LAN Settings... 66 Wireless Settings... 67 MAC Address... 67 Network Reset... 67 Enable External Com... 67

VII Parts Replacement

69

Maintenance warnings/cautions

69

Service warnings ... 69 Service cautions ... 69

Battery pack

70

Tools needed... 70 Removing the battery pack... 70

Table of Contents Installing a battery pack... 70 Verifying battery function after new battery replacement... 70

Opening & closing the pump housing 70 Tools needed... 70 Opening the pump housing... 70 Closing the pump housing... 71 Verify pump function... 71

Interconnect PCB with radio module

71

Tools needed... 71 Removing the Interconnect PCB... 71 Installing an Interconnect PCB... 72 Load software... 72 Verify Interconnect PCB function... 72

Radio PCB and Thermal Pad

72

Tools needed... 72 Removing the Radio PCB from the Interconnect PCB... 72 Installing a Radio PCB... 73 Verify Radio PCB function... 73

Antenna

73

Tools Needed... 73 Removing the antenna... 73 Installing an antenna... 73 Verify antenna function... 73

Speaker

74

Tools Needed... 74 Speaker removal... 74 Speaker Installation... 74 Verifying speaker function ... 74

AC power supply

74

Tools needed... 74 Removing AC power supply... 74 Installing an AC power supply... 74 Verify AC power supply function... 75

Bottom housing

75

Tools Needed... 75 Removing the bottom housing... 75 Installing a bottom housing... 75

Main PCB

75

Tools needed... 75 Removing the Main PCB... 75 Installing a Main PCB... 76 Load Main PCB software... 76 Verify pump function... 76

Drive train assembly

77

Tools Needed... 77 Motor unit (motor, worm, worm gear)... 77 Removal... 77 Installation... 77

Reassemble motor unit... 77 Position potentiometer... 77 Removal... 77 Installation... 78

Clutch assembly

78

Tools needed... 78 Leadscrew... 78 Removal... 78 Installation... 79 Clutch or clutch cam... 79 Tools needed... 79 Removal... 79 Installation... 79 Plunger cable... 80 Removal... 80 Installation... 80

LCD and backlight

80

Tools Needed... 80 Removing LCD and/or backlight assembly... 80 Installing an LCD and/or backlight assembly... 80 Verify LCD & backlight assembly function... 81

Keypad

81

Tools needed... 81 Removing the keypad... 81 Replacing the keypad... 82

Syringe barrel clamp assembly

82

Tools Needed... 82 Barrel clamp head... 82 Removal... 82 Installation... 82 Verify Function... 82 Barrel clamp body assembly ... 83 Removal... 83 Installation... 83

Ear clip, handle & guide

83

Tools Needed... 83 Ear clip ... 83 Removal... 83 Installation... 83 Ear clip optical sensor ... 83 Removal... 83 Installation... 84 Handle... 84 Removal... 84 Installation... 84 Tubing guide... 85 Removal... 85 Installation... 85

Plunger case assembly

85

Tools needed... 85 Plunger lever... 85 Removal... 85 v

Table of Contents Installation... 85 Plunger case disassembly... 85 Disassembly... 85 Reassembly... 86 Cam gear and timing plate... 86 Removal... 86 Installation... 86 Verify timing plate placement and flipper gears are in sync... 86 Flipper and flipper gear... 86 Removal... 86 Replacement... 87 Plunger board... 87 Additional tools needed... 87 Removal... 87 Replacement... 87 Force sensor... 87 Additional tools needed... 87 Removal... 87 Replacement... 88 Left plunger case... 88 Additional tools needed... 88 Removal... 88 Replacement... 88

VIII Calibration and Adjustment

91

Using Biomed > Calibration

91

Biomed > Calibration ... 91 Calibrate (Syringe) size and position... 93 Performing both size & position calibration... 93 Calibrate force sensor... 95 Calibrate plunger position... 96 Calibrate syringe size sensor... 97 Adjust contrast (voltage) setting... 98 View calibration data... 99 Save changes and exit... 100 Exit calibration without saving changes... 100

Retest guidelines

101

IX System Layout

103

System layout

103

Circuit Diagrams and PCB Schematics... 104

vi

X Assembly Drawings & Parts Lists

105

Assembly drawings

105

Medfusion® Model 4000 pump series main pump assembly... 106 Medfusion® Model 4000 pump series main pump assembly – parts list... 107 Case bottom assembly... 108 Case bottom assembly – parts list... 109 Case top assembly w/plunger... 110 Case top assembly w/plunger – parts list... 111 Case top assembly without plunger... 112 Case top assembly without plunger – parts list... 113 Barrel clamp assembly... 114 Barrel clamp assembly – parts list... 115 Drive train assembly... 116 Drive train assembly – parts list... 117 Clutch assembly... 118

Accessories – parts list

119

Poleclamp assembly... 119 Rotating poleclamp parts ... 120 Miscellaneous parts... 120 Calibration & repair – parts list... 121 Medfusion® Model 4000 pump calibration kit... 121 Other tools & equipment required to service Medfusion® Model 4000 pumps... 121

Notes

122

Index

125

Introduction

Important Information WARNING: Read this entire manual before attempting and service or repair on a Medfusion® Model 4000 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).

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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.

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Warnings •

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This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. This equipment/system is intended for use by healthcare professionals only. The equipment/ system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the Medfusion® Model 4000 pump or shield the location. The unauthorized modification of this product may constitute a safety hazard, which could lead to patient injury or death, as well as the potential for property damage. Unauthorized modification will also void the Limited Warranty. This device contains an RF transmitter which may interfere with aircraft systems.

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Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided. Portable and mobile Radio Frequency (RF) communications equipment can affect medical electrical equipment. 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. Use of cables other than as listed and with equipment other than those specified may result in increased EMC emissions or decreased immunity of the pump. It is recommended that when connecting the pump to a network using an Ethernet cable, the network equipment should conform to EN/IEC 60950. Once the package is placed on the PharmGuard® Server for deployment, there is no way to recall it. Always verify and validate the configuration on single pumps prior to deploying it to the PharmGuard® Server. 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 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 1

Introduction

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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. 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. While servicing the Medfusion® Model 4000 pump you should wear safety glasses as it contains springs and other small parts which may be a hazard.

Cautions •

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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. Avoid Using Solvents: NEVER use organic solvents (e.g., acetone), quarternary ammonia compounds, strong acids, or bases to clean any portion of the pump.

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Spray Resistant: The pump is “spray resistant” from the top and sides but not “water proof ”. NEVER spray cleaning or other fluids directly into openings on the bottom of the pump.

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Not Waterproof: The pump is not certified “water proof ”. Never immerse the pump in water or other fluids.

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Avoid Oil Sprays: NEVER use light oil sprays (e.g., WD40®) to clean or lubricate pump. These oils contain chemicals that can damage the plastic of the pump. No user-added lubrication is necessary.

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Never Autoclave: NEVER sterilize the pump in a steam autoclave or using gas. Using autoclave or

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gas sterilization can seriously damage the infusion pump and void the warranty. Battery Replacement: Observe ESD handling precautions when replacing the battery. Replace battery only with Smiths Medical original parts. Recycle batteries in compliance with applicable local regulations. 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 30 in.-oz. (0.21 Nm). Battery Disposal: Always dispose of exhausted Lithium Ion 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.

Introduction

Contents of this manual This is the technical service manual for Medfusion® Model 4000 pump manufactured by Smiths Medical. 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® Model 4000 pump. Such information is found in manuals specific to each individual model, (e.g., the Operator’s Manual). The sections of this manual are: Introduction •

• Overview of contents and purpose of this manual. Network Configuration

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.

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Description of the process of configuring pumps for the network. 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® Model 4000 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® Model 4000 pump. Calibration Detailed procedures for calibration of Medfusion® Model 4000 pump. Assembly Drawings and Parts Lists •

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

3

Introduction

About the pump Features and Controls Following are several illustrations showing the various controls, connectors and features of the Medfusion® Model 4000 pump.

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





 *



 *

 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

PRIME / BOLUS

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 to allow placement of the syringe plunger onto the holder during loading, or to remove it during unloading. 9 Keypad: See Keypad closeup (next page) for identification of the individual keypad keys and what they are used for.

Introduction

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

 

10 AC Power Connection Port: Plug the AC power cord into connection port to allow pump to operate on AC (mains) power. 11 Ethernet Port: Plug an Ethernet network cable into the port to receive and send Configurations and data. 12 Optional Poleclamp Mount: If desired, attach the optional poleclamp here. 13 Pump Base / Bottom

Keypad closeup PRIME / BOLUS

G6000912 Rev 0

5

Introduction Key

í)

Alarm Silence (

ë)

Power (

Menu keys (softkeys) Back (â)

Numbers & Decimal

á) Start (É) Stop (

è)

Prime / Bolus (

Indicator ò - Alarm

ô - AC Line õ - Battery ö - Lock

ù - Infusing

When pump is paused Silences audible alarm. Allows operator to switch the display backlight from bright to dim or dim to bright. Allows redisplay of the text for the last active alarm. Silence certain active alarms. Push and hold to turn pump off. Function is defined on the display. Reverts to a previous step or level.

Set number values or selects menu items. N/A

When pump is delivering Silences audible alarm. Allows operator to switch the display backlight from bright to dim or dim to bright. Silence certain active alarms (some alarms must be silenced with í before ë will function). 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. Briefly displays the battery life indicator, network connection type, data server status and PDD/PVD. Set number values or selects menu items. Stops delivery (pump remains on).

Starts delivery.

N/A

Begins priming after confirmation.

Displays the programmed bolus programming or confirmation/Begin Delivery screen.

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 Alarm 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 battery is charging. The Lock indicator indicates the pump has been locked into its current operational mode. While this indicator is lit, 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 informational message. The Infusing indicators are 3 green lights, which illuminate in sequence right to left when the pump is infusing. During intermittent volume over time delivery mode, a single Infusing indicator lights during the time between infusions.

 - Communicating 6

When the pump is off or stopped, the Infusing indicator is not lit. The Communicating indicator (blue) is on whenever the pump is communicating with the PharmGuard® Server using wireless or wired interface. There is no audible tone associated with communications. During normal network operations the light may periodically turn on and off. The Communicating indicator has no affect on clinical operations of the pump.

Introduction

Understanding “Biomed” mode Periodic maintenance and troubleshooting on Medfusion® Model 4000 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 next preventive maintenance date. Biomed is for viewing the time and date. Biomed is used for installing updates. Biomed is used to check network settings and enable external commands.

Authorized Biomed access Never use Biomed features unless you are trained in maintenance of the Medfusion® Model 4000 pumps and have been authorized by your facility to use the Biomed program.

Biomed software program – major options The Biomed menu has six major modes on its selection screen: 1. Calibration to check calibration values, re-calibrate sensors or adjust 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 view time and date, to update periodic maintenance timestamp.

4. Set Language allows changing the pump’s display language. Currently only English is available. 5. System Update Status indicates whether system updates (Configuration and/or Firmware) are available and allows starting installation process. 6. Network Settings to view the network settings, view the pump’s MAC address, perform a network reset, or enable the pump for External Commands. The following is an outline of the Biomed menu: Calibration

Diagnostics

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

• Audio test • Display test • Indicator test • Keypad test • Monitor analog sensors • save changes and exit • Monitor digital sensors • Monitor battery status • Drive train test • Motor drive test • Monitor a2d self test • Monitor 6811 a2d grp1 • Monitor 6811 a2d grp2 Set Language System Update Status

Utilities • set/view next pm date • view time/date • view alarm history • view infusion history • view software crcs • view software versions • view service data • view EEPROM size

(View system update status and begin installation) Network Settings • LAN settings • Wireless settings • MAC address • Network reset • Enable External Com (commands)

7

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.

>

Serial number

J

Type CF equipment (protection from electric shock) Class II 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. Date of manufacture Catalog number 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

f Caution K

J <

ó

P _ Humidity limitation i Atmospheric pressure limitation ED

WD V~ IPX3

î



8

E=Wired Connection, D=Device Server Connection W=Wireless connection, D=Device Server Connection Operating voltage range for alternating current (i.e. AC or mains) power source Equipment that is ingress protected from fluid spraying at a vertical angle from above, and from angles to 60° on either side of vertical Non-ionizing radiation MR (Magnetic Resonance) Conditional

CCK Ü

Australian c-tick mark. Indicates that the product complies with the applicable standard and establishes a traceable link between the equipment and the manufacturer, importer or their agent responsible for compliance and for placing it on the Australian or New Zealand market. Pins of connectors and other areas identified with this ESD Warning symbol should not be touched. Connections should only be made when ESD precautionary measures are used.

Z Collect Separtely

For a complete description of the symbols used on the pump’s keypad, see “Keypad Closeup” starting on page 5.

Introduction

Glossary of Technical Terms

This is a glossary of technical terms relating to the Medfusion® Model 4000 pumps.

Term

Definition

AC Line Leakage Test

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, when doing line leakage testing 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. 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 Base Battery Gauge

The Medfusion® Model 4000 pump achieves protection by double-isolating secondary power and exposed metal from AC power. The Medfusion® Model 4000 pump satisfies the UL requirement that 4000 VAC 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 a Watchdog Alarm, and 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 bottom housing of the pump, which contains the Interconnect PCB and it’s associated system memory (SDRAM, FLASH and EEPROM). 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.

9

Introduction Term

Definition

Battery Parameters

Battery parameters can be viewed by selecting Biomed > Diagnostics > Monitor Battery Status. Refer to the Battery Maintenance and Biomed Diagnostics sections of this manual. A set of functions for calibration/adjustment of the sensors within the Medfusion® Model 4000 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 Next PM Date − Used to view and set the Preventive Maintenance (PM) date. • View Time / Date − Used to view 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. • View Service Data − Displays a variety of pump related data, such as how many hours since it was last calibrated, how many motor revolutions, etc. • View EEPROM Size − Displays the size of the pump’s EEPROM. Broadcast Address A special type of networking address that is reserved for sending messages to all machines on a given network segment. Depleted Battery Monitor The circuitry which measures present battery charge status against stored battery capacity data to determine a “depletion” situation. DHCP Dynamic Host Configuration Protocol. Devices connected to IP networks must be “configured”, or attached to the network, before they can communicate with other devices on the network. DHCP allows devices to be attached automatically. DHCP also keeps track of connected devices in order to prevent two devices from accidentally having the same IP address. •

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Introduction Term

Definition

DNS

Domain Name System. A hierarchical naming system for computers, services, or resources connected to the Internet or a private network. It associates various information with assigned domain names, and translates domain names meaningful to humans into the numerical identifiers associated with networking equipment for the purpose of locating and addressing these devices worldwide. The EN 475 alarms use tones designed for use by customers following European standards. These generate High, Medium & Low Priority Alarms. The Ethernet port interfaces directly with the main microprocessor’s asynchronus serial communication pins. Use an Ethernet cable of less than 3 m (9.75 feet). Exceeding this length could result in increased susceptibility to external electromagnetic interference. Circuitry which determines when and if external power has been or is connected to the pump. The pump uses flash memory, which is re-programmable through the Ethernet port or wirelessly over a network using a remote computer. An internetworking system capable of joining together two networks that use different base protocols. A network gateway can be implemented completely in software, completely in hardware, or as a combination of both. A ‘default gateway’ is the device that passes traffic from the local subnet to devices on other subnets. Globally Unique Identifier. A unique 128-bit number produced by Windows® operating systems or applications to identify a particular component, application, file, database entry, and/or user. Both the firmware and PharmGuard® Toolbox 2 Configuration present on the Medfusion® Model 4000 pump have such an identifier. The top housing of the pump, which contains the Main PCB and and it’s associated memory (FLASH and EEPROM). A high-priority alarm is initiated by any condition that halts an ongoing infusion. High priority alarms are signaled with a flashing red indicator, a viewing screen backlight that oscillates between bright and dim, and a repeating audible signal. Press í to return the viewing screen backlight to bright and silence the audible alarm for the programmed alarm silence period. During a high-priority alarm condition, all keys except í are locked. You must silence the alarm by pressing í before any other action can be taken.

EN 475 Alarms Ethernet Port

External Power Detector Flash Memory Gateway

GUID

Head High Priority Alarms

If the front panel controls are locked when a high-priority alarm occurs, the pump controls do unlock.

Interconnect PCB IPv4 Address

A high-priority alarm that stops delivery during a loading dose or bolus will not return to the Begin Delivery screen until the alarm is silenced – this allows you to record the portion of the loading dose/bolus volume delivered prior to the alarm sounding. The interconnect PCB (Printed Circuit Board) interfaces to an intelligent Lithium Ion Battery, the system speaker, the internal DC supply, the ethernet jack, the wireless radio module and the main PCB. An internet protocol address of the form, w.x.y.z, where w, x, y, and z are decimal numbers in the range of 0-255. The address is between 7 and 15 characters long.

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Introduction Term

Definition

IPX3

Equipment that is ingress protected from fluid spraying at 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 provides user feedback related to interaction with the pump.

Keypad Test LCD LCD Backlight Limit Priority Alarms

Note: The audio part of Limit priority alert is tied to “Key Click loudness”, which is set in PharmGuard® Toolbox 2. If key click loudness is set to Off, there will be no audible tone accompanying Limit priority alerts (visual alerts will still appear in the display). The volume will otherwise sound at the loudness level selected for keyclicks - Level 2 (quietest), Level 3, Level 4, or Level 5 (loudest). A limit-priority alarm sounds a three tone, non-repeating audible signal and displays an advisory message on screen for 3 seconds.

Low Priority Alarms

If the front panel controls are locked when a low-priority alarm occurs, the pump controls do not unlock. A low-priority alarm indicates any condition not requiring immediate operator intervention. Low-priority alarms are announced with a continuous yellow indicator, a viewing screen backlight that oscillates between bright and dim and a non-repeating audible signal. During a low-priority alarm condition, all keys except í are locked. You must silence the alarm by pressing í before any other action can be taken.

Medium Priority Alarms

Motor Rotation Sensor Net Mask NTP

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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 intervention but does not halt infusion. Medium-priority alarms are signaled with a flashing yellow indicator, a viewing screen backlight that oscillates between bright and dim, and a repeating audible signal. Pressing í will return the viewing screen backlight to bright and silence the audible alarm for the programmed alarm silence period. During a medium-priority alarm condition, all keys except í are locked. You must silence the alarm by pressing í before any other action can be taken. If the front panel controls are locked when a medium-priority alarm occurs, the pump controls do not unlock. An optical sensor on the main PCB senses the movement of the motor worm shaft. A netmask is a code of numbers used to transfer messages correctly among machines in the same subnet on a network. It works together with a network’s router to determine where the data goes when it is received. Network Time Protocol. A protocol for synchronizing the clocks of devices connected to data networks.

Introduction Term

Definition

User Call Back

The user call back alarm is a medium priority alarm which simply reminds you to finish what you started. Once programming of an infusion is begun, the pump expects programming to continue until it is complete.

Occlusion Plunger PCB Safety Class II, Type CF Equipment Serial EEPROM SSID Set / View Next PM Date Static Address Stepper Motor System Failure Primary Speaker System Update Status

View Alarm History View Infusion History View Software CRCs View Software Versions Watchdog Circuit

If the pump is paused too long (30 seconds) on any data entry screen, then the pump begins sounding a medium priority alarm. 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 (printed circuit board) provides pre-amplification of the force sensor output to the Main PCB, 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 PCB to store calibration, configuration, and infusion history. Service Set Identification. A 32-character alphanumeric key uniquely identifying a wireless LAN (Local Area Network). Its purpose is stop other wireless equipment accessing your LAN - whether accidentally or intentionally. This allows viewing the Next scheduled preventive maintenance date. This is where you also set the date when completing annual preventive maintenance. Hard-coded IP address assigned to a specific device connected to a network. A sequentially stepping motor used to drive the plunger head of the pump. An alarm indicating that the pump has detected a hardware and/or software failure. The main speaker located in the bottom housing of the pump. All normal alarm/ alert tones are generated through this speaker. “Packages”, consisting of new configuration or software update(s), may be stored on the network and deployed to pumps via wireless (a notification alarm and “Update(s) Available” alert is sent to the pump), or occurs when the pump is connected to Ethernet. These updates can be accessed and installed via System Update Status in the Biomed menu. 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. For “factory use” only. View both the bootbank version, main version and build number of the operational software installed in the Medfusion® Model 4000 pump. While in the power on state, the auxiliary controller prevents the watchdog Alarm State from occurring.

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Introduction

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