Technical Service Manual
140 Pages
Preview
Page 1
Medfusion® Syringe Infusion Pump Model 4000 Series
Technical Service Manual
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 Tel: 1 800 258 5361 (US/CA) Tel: +1 614 210 7300 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 reinstalled on the pump prior to it’s return to use.
ii
Table of Contents
Table of Contents I Introduction
1
Important Information
1
Warnings ... 1 Cautions... 3
Contents of this manual
4
Authorized use of this manual ... 4
About the pump
5
Features and Controls... 5 Keypad closeup ... 6
Understanding “Biomed” mode
8
What is Biomed? ... 8 Authorized Biomed access ... 8 Biomed software program – major options... 8 Symbols... 9 Glossary of Technical Terms ... 10
II Network Communication
15
PharmGuard® Toolbox 2 Communication
15
Teach Configuration ... 15 Create Package... ... 16 Update Pumps ... 16
Updates via DL4000
16
Updates via SureLink™ Remote Support Software 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 ... 23 asset... ... 23 Usage ... 23 Constraints ... 23 Notes ... 23 factory ... 23 Usage ... 23 network_stats ... 23 Usage ... 23 ls (l is a lower case L)... 23 Usage ... 23 cat... ... 23 Usage ... 23 flash_coldfire ... 24 Usage ... 24 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 Storage/Transport and Operating Condition Requirements ... 28 Service warnings ... 28
Periodic maintenance
29 iii
Table of Contents Installation/quick check-out ... 29 Quick check-out test ... 29 Cleaning and care ... 30 Standard cleaning of Medfusion® Model 4000 pumps ... 30
Mandatory annual maintenance testing
31
General inspection ... 31 Power-up test ... 31 Calibration verification... 32 Force sensor check ... 32 Small syringe size and position sensor check ... 32 Large syringe size and position sensor check ... 33 Plunger travel test ... 33 Motor drive & occlusion operational test ... 34 Flow delivery accuracy test... 34 AC line leakage test ... 35 Battery maintenance ... 36 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 Overview of operation
39 39
Controlling motor functions ... 39 Infusion control & safety functions ... 39
Pump design description
40
Logic core ... 40 Main printed circuit board (PCB) ... 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 iv
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 printed circuit board (PCB) ... 43 Force preamplifier function ... 43 Force sensing interface description... 43 Plunger flipper sensor function ... 43 Interconnect printed circuit board (PCB) ... 43 AC power detection description... 43 Ethernet data ports description ... 43 Battery pack / charger description ... 44 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 ... 51 System Failure Alarms ... 52 General troubleshooting ... 57
Smiths Medical service and support
60
Using Smiths Medical service assistance ... 60 Returning a pump for repair... 60
Using Biomed for troubleshooting
61
Accessing Biomed ... 61 Biomed > Calibration ... 61 Biomed > Diagnostics (screen 1 of 2) ... 62 Audio Test... 62 Display Test ... 62 Indicator Test ... 62 Keypad Test ... 62 Monitor Analog Sensors ... 62 Monitor Digital Sensors ... 62 Monitor Battery Status ... 63 Drive Train Test ... 63 Biomed > Diagnostics (screen 2 of 2) ... 63 Motor Drive Test ... 63 Monitor a2d Selftest ... 63 Monitor 6811 a2d Group1 ... 63 Monitor 6811 A2D Group2 ... 64 Biomed > Utilities... 64 Set/View Next PM Date ... 64 View Time/Date (Current) ... 64 View Alarm History ... 64 View Infusion History ... 64
Table of Contents View Software CRCs & View Software Versions ... 64 View Service Data ... 65 View EEPROM Size ... 65 Biomed > Set Language ... 65 Biomed > System Update Status ... 65 Biomed > Network Settings ... 65 LAN Settings... 65 Wireless Settings ... 65 MAC Address ... 66 Network Reset ... 66 Enable External Com... 66
AC power supply
72
Tools needed ... 72 Removing AC power supply ... 72 Installing an AC power supply ... 72 Verify AC power supply function ... 73
Bottom housing
73
Tools Needed ... 73 Removing the bottom housing ... 73 Installing a bottom housing ... 73
Main PCB
73
Service warnings ... 67 Service cautions ... 67
Tools needed ... 73 Removing the Main PCB... 73 Installing a Main PCB... 74 Load Main PCB software ... 74 Verify pump function ... 75
Battery pack
Drive train assembly
VII Parts Replacement
67
Maintenance warnings/cautions
67
68
Tools needed ... 68 Removing the battery pack ... 68 Installing a battery pack ... 68 Verifying battery function after new battery replacement ... 68
Opening & closing the pump housing 68 Tools needed ... 68 Opening the pump housing ... 68 Closing the pump housing ... 69 Verify pump function ... 69
Interconnect PCB with radio module
69
Tools needed ... 69 Removing the Interconnect PCB ... 69 Re-Installing the Interconnect PCB... 70 Verify Interconnect PCB ... 70
Radio PCB and Thermal Pad
70
Tools needed ... 70 Removing the Radio PCB from the Interconnect PCB ... 70 Installing a Radio PCB ... 71 Verify Radio PCB function ... 71
Antenna
71
Tools Needed ... 71 Removing the antenna ... 71 Installing an antenna ... 71 Verify antenna function ... 71
Speaker
71
Tools Needed ... 71 Speaker removal ... 72 Speaker Installation... 72 Verifying speaker function ... 72
75
Tools Needed ... 75 Motor unit (motor, worm, worm gear)... 75 Removal ... 75 Installation ... 75 Reassemble motor unit... 75 Position potentiometer ... 76 Removal ... 76 Installation ... 76
Clutch assembly
76
Tools needed ... 76 Leadscrew ... 77 Removal ... 77 Installation ... 77 Clutch or clutch cam... 78 Tools needed ... 78 Removal ... 78 Installation ... 78 Plunger cable ... 78 Removal ... 78 Installation ... 78
LCD and backlight
78
Tools Needed ... 78 Removing old-style LCD and/or backlight assembly ... 79 Removing new-style LCD display (70-0311 or 70-0513) ... 79 Re-Installing an old-style LCD and/or backlight assembly ... 79 Installing new-style LCD display (70-0311 or 70-0513) .. 80 Verify LCD/backlight function... 80
v
Table of Contents Keypad
80
Tools needed ... 80 Removing the keypad ... 80 Replacing the keypad ... 81
Syringe barrel clamp assembly
81
Tools Needed ... 81 Barrel clamp head... 81 Removal ... 81 Installation ... 81 Verify Function ... 82 Barrel clamp body assembly ... 82 Removal ... 82 Installation ... 82
Ear clip, handle & guide
82
Tools Needed ... 82 Ear clip ... 82 Removal ... 82 Installation ... 82 Ear clip optical sensor ... 83 Removal ... 83 Installation ... 83 Handle... 83 Removal ... 83 Installation ... 83 Tubing guide ... 84 Removal ... 84 Installation ... 84
Plunger case assembly
84
Tools needed ... 84 Plunger lever ... 84 Removal ... 84 Installation ... 84 Plunger case disassembly ... 84 Disassembly ... 85 Reassembly ... 85 Cam gear and timing plate ... 85 Removal ... 85 Installation ... 85 Verify timing plate placement and flipper gears are in sync ... 85 Flipper and flipper gear ... 86 Removal ... 86 Installation ... 86 Plunger PCB ... 86 Additional tools needed... 86 Removal ... 86 Installation ... 86 Force sensor ... 87 Additional tools needed... 87 Removal ... 87 vi
Installation ... 87 Left plunger case ... 87 Additional tools needed... 87 Removal ... 87 Installation ... 88
VIII Calibration and Adjustment
89
Using Biomed > Calibration
89
Biomed > Calibration ... 89 Calibrate (Syringe) size and position... 91 Performing both size & position calibration ... 91 Calibrate force sensor ... 93 Calibrate plunger position ... 94 Calibrate syringe size sensor ... 95 Adjust contrast (voltage) setting ... 96 View calibration data ... 97 Save changes and exit... 98 Exit calibration without saving changes ... 98
Retest guidelines
99
IX System Layout
101
System layout
101
Circuit Diagrams and PCB Schematics ... 102
X Assembly Drawings & Parts Lists
103
Assembly drawings
103
Medfusion® Model 4000 pump main pump assembly ... 104 Medfusion® Model 4000 pump main pump assembly – parts list ... 105 Case bottom assembly ... 106 Case bottom assembly – parts list ... 107 Case top assembly w/plunger ... 108 Case top assembly w/plunger – parts list ... 109 Case top assembly without plunger ... 110 Case top assembly without plunger – parts list ... 111 Barrel clamp assembly ... 112 Barrel clamp assembly – parts list ... 113 Drive train assembly ... 114 Drive train assembly – parts list ... 115 Clutch assembly ... 116 Clutch assembly – parts list... 116
Accessories – parts list
117
3000RPC Poleclamp assembly... 117 3000RPC Rotating poleclamp parts ... 118 90-Degree poleclamp assembly ... 119 90-Degree rotating poleclamp parts ... 120 100-Degree poleclamp assembly ... 121
Table of Contents 100-Degree rotating poleclamp parts ... 122 Miscellaneous parts ... 122 Calibration & repair – parts list... 123 Medfusion® Model 4000 pump calibration kit ... 123
Notes
124
Index
127
vii
Table of Contents
This page intentionally left blank.
viii
Introduction
Important Information WARNING: Read this entire manual before attempting 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). 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.
•
• •
•
Note: This manual supersedes all previous revisions. IMPORTANT: Pumps displaying the CE mark built after 22-July-2014 are RoHS (Restriction of Hazardous Substances) compliant and contain RoHS compliant parts.
•
Warnings
•
•
•
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 (including the risk of fire). Use only Smiths Medical supplied service/ replacement parts, including the battery pack. Unauthorized modification and/or the use of unauthorized service/replacement parts will also void the Limited Warranty. This device contains an RF transmitter which may interfere with aircraft systems. 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. Once the package is deployed via the PharmGuard® Server there is no way to recall it. Always verify and validate a configuration on single pumps prior to deploying it via 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. 1
Introduction •
•
•
•
•
•
•
•
2
Power Source: To avoid electric shock, before cleaning, always switch electrically operated equipment off and disconnect from AC power source. 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. 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. Disconnect AC Power & Turn Pump Off: 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 inside the pump. Make sure the pump is turned off before performing any disassembly. Battery Replacement: For continued protection against fire hazard, always replace battery pack with the same type and model of battery specified in the labeling on the pump. 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. Pump Maintenance: Only trained biomedical service personnel may repair, calibrate, and maintain this pump. 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.
Introduction
Cautions •
•
•
•
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. 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. Wrapping the power cord tightly around the pump body for storage/transport can cause separation/damage to the power cord insulation. DO NOT USE cleaning solutions containing: acetone, ammonia, ammonium chloride (including Hyamine 1622), aromatic solvents (such as paint thinner, toluene, methylbenzene), chlorinated solvents (such as methyl ethyl ketone (MEK), trichloroethane), ether (such as ethylene glycol monobutyl ether, diethylene glycol butyl ether) or oxidizing acids (such as phosphoric acid, sulfuric acid or accelerated hydrogen peroxide). Use of the solutions or solvents listed as DO NOT USE could damage plastic parts and cause premature failure or device malfunction.
•
Use only the recommended cleaning/disinfecting agents and method. Use of cleaning/disinfecting agents and method other than those listed may cause damage to the pump and will void the warranty.
•
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.
•
Not Waterproof: The pump is not certified “water proof”. Never immerse the pump in water or other fluids.
•
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.
•
•
•
• •
•
Never Autoclave: NEVER sterilize the pump in a steam autoclave or using gas. Using autoclave or 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. 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. 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, torque all screws to 60 in.-oz. (0.42 Nm). The Keypad is NOT Flexible: Whenever handling the keypad, always ensure it remains flat. Bending the keypad can damage keys or break LED contacts.
3
Introduction
Contents of this manual
Authorized use of this manual
This is the technical service manual for Medfusion® Model 4000 pumps manufactured by Smiths Medical. Its purpose is to provide the technical information necessary for maintenance, troubleshooting and repair of these pumps.
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.
•
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 Communication •
Description of the process of configuring pumps for the network. Telnet Commands •
Discussion of connecting to Telnet and various commands and settings. Scheduled Maintenance •
List of tests for required annual maintenance, and the procedure for completing each test. Theory of Operation •
Descriptions of the systems which control the operation of the 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 pump parts. Calibration and Adjustment • Detailed procedures for calibration of the pump. System Layout • Contains a diagram of the system layout. Assembly Drawings and Parts Lists •
4
Contains mechanical assembly parts lists and replacement parts lists for repairs.
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.
Introduction
About the pump Features and Controls Following are several illustrations showing the various controls, connectors and features of the Medfusion® Model 4000 pump.
%
&
$
'
) (*
*
#
(*
+ 1 LCD Display: Pump operating and status information appears on the LCD display. 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. 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 (page 6) for identification of the individual keypad keys and what they are used for.
5
Introduction
,
/ .
10 AC Power Connection Port: Plug the AC power cord into connection port to allow pump to operate on AC (mains) power. Note installed AC receptacle seal. 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
6
-
Introduction Key Alarm Silence (
Power (
)
)
Menu keys (softkeys) Back ()
Numbers & Decimal
) Start ()
Stop (
Prime / Bolus (
)
Indicator ò - Alarm
- AC Line õ - Battery ö - Lock
- 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 before 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 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 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
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. 7
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. The Biomed menu: • •
•
•
• •
has its own security access code; contains a Calibration menu for use in calibrations of the pump’s sensors and allows some error codes to be reset; contains a Diagnostics menu for use in diagnosis of digital and analog sensors contained in the pump, as well as testing the pump’s drive systems and monitoring the status of the pump’s battery; allows access to infusion history log and alarm history log stored in the pump, is used for setting/ viewing the pump’s next preventive maintenance date and viewing the time and date; is used for installing updates; 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. A passcode (2580) is required to access the Biomed menu.
Biomed software program – major options The Biomed menu has six major modes on its selection screen: 1. Calibration to check calibration values, recalibrate 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 8
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 system update status and begin installation) Network Settings
• LAN settings • view time/date • Wireless settings • view alarm history • MAC address • view infusion history • Network reset • view software crcs • Enable External Com (commands) • view software versions • view service data • view EEPROM size
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.
f < > D H
Caution
@
Z
Date of manufacture Manufacturer Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician. Authorized representative in the European Community Temperature limitation
Type CF equipment (protection from electric shock) Collect Separately MR (Magnetic Resonance) Conditional
A K
ó
V~ IPX3
Serial number
P _ Humidity limitation i Atmospheric pressure limitation
WD
Catalog number
Not made with natural rubber latex
6
ED
î
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 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. Electrostatic sensitive devices
Ü (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.)
For a complete description of the symbols used on the pump’s keypad, see “Keypad Closeup” starting on page 6.
Indicates the product was designed and manufactured in accordance with applicable standards/guidelines and may be sold in the EU (European Union). 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. UL Mark for Canada and the United States. Indicates the product was manufactured in accordance with the requirements of UL (Underwriter’s Laboratory). 9
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” (page 14). 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 its 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.
10
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. 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. 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.
11
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 its associated memory (FLASH and EEPROM). 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 do unlock.
EN 475 Alarms Ethernet Port
External Power Detector Flash Memory Gateway
GUID
Head High Priority Alarms
Interconnect Printed Circuit Board (PCB) IPv4 Address IPX3 Keypad Test LCD LCD Backlight
12
High Priority alarms are signaled by a flashing red indicator and an audible signal. to pause the audible alarm for the preset alarm silence period. Press The Interconnect PCB 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. Equipment which 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.