BC Biomedical IPA-2000S, IPA-2000 User Manual
IPA-2000S
Infusion Pump Analyzer
with Safety Analyzer
IPA-2000
Infusion Pump Analyzer
User Manual
Manual 2000S01
Copyright © 2002
Revision 8
October 2003
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INTRINTR
INTR
INTRINTR
NOTICES
LIMITED WARRANTY
WARRANTY: BC Biomedical warrants its new products to be free from defects in
materials and workmanship under the service for which they are intended. This warranty
is effective for twelve months from the date of shipment.
EXCLUSIONS: This warranty is in lieu of any other warranty, expressed or implied;
including, but not limited to, any implied warranty of merchantability or fitness for a
particular purpose.
BC Biomedical is not liable for any incidental or consequential damages.
No person other than an officer is authorized to give any other warranty or assume any
liability.
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REMEDIES: The purchaser’s sole and exclusive remedy shall be:
(1) The repair or replacement of defective parts or products.
(2) At the discretion of BC Biomedical, the refund of the purchase price.
Specifications and information contained in this document are for informational use
only and are subject to change without notice. This material should in no way be
construed as a commitment by BC Biomedical. It has been checked carefully and is
believed to be correct. However, no responsibility or liability for any errors or
inaccuracies is assumed by BC Biomedical.
The unit covered by this manual is for routine maintenance only. It is not to be used for
calibration.
ii
NOTICES
INTRODUCTIONINTRODUCTION
INTRODUCTION
INTRODUCTIONINTRODUCTION
PRODUCTS COVERED BY MANUAL
This manual gives a comprehensive overview of all the available features for the IPA2000 Series of products. Some of the sections and information are not applicable to
every product.
IPA-2000S: This product includes the Infusion Pump Analyzer and the Safety Analyzer.
All portions of this manual are applicable.
IPA-2000: This product includes only the Infusion Pump Analyzer. The portions of this
manual referring to the Safety Analyzer are not applicable.
DOCUMENT REVISION RECORD:
REVISION DATE PROGRAM VERSION CHANGES
1 7/02 DT7310CB 1.2 Beta Version Release
2 10/02 DT7310CD (2000S) 1.4 (2000S) Specifications Updated
DT7315CA (2000) 1.1 (2000) 2000 References
3 1/03 DT7310CF (2000S) 1.6 (2000S) Specifications Updated
DT7315CC(2000) 1.3 (2000) Editing Updates
4 4/03 DT7310CG(2000S) 1.7(2000S) Priming, Purging and
DT7315CD(2000) 1.4(2000) Editing Updates
5 5/03 DT7310CH(2000S) 1.8(2000S) Editing
DT7315CE(2000) 1.5(2000) Updates
6 6/03 DT7310CI(2000S) 1.9(2000S) Alarm List Adjusted
DT7315CF(2000) 1.6(2000)
7 7/03 DT7310CJ(2000S) 1.10(2000S) Specifications Updated
DT7310CF(2000) 1.6(2000)
8 10/03 DT7310CK(2000S) 1.11(2000S) Line Voltage, Baud
DT7310CF(2000) 1.6(2000) Rate and Alarm Scan
P:\Manuals\BCGroup\---\7310_rev08_---.pmd
iii
NOTICES
TABLE OF CONTENTS
INTRINTR
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Part 1 About the IPA-2000 Series A general overview of the System....................
Infusion Pump Analyzer Overview.....................
Safety Analyzer Overview.....................................
Instrument Overview
Instrument Physical Overview..............................
Unit Front
Unit Front
Unit Back
Module
Module Back
Commercial and Main Screen
Connections
Connections Overview
-
Panel...................................................
-
Panel Controls....................................
-
Panel...................................................
Front-Panel.............................................
-
Panel..............................................
.
............................
.
........................................
1-1
1-3
1-4
1-5
1-6
1-7
1-9
1-10
1-11
1-12
1-13
iv
Module Connection
Printer Connection
Keyboard Connection
Computer Connection..........................................
Infusion Pump Analyzer
Safety Analyzer
Specifications
.
.............................................
.
..............................................
.
..........................................
/
DUT Connection.........
/
DUT Connection......................
.
...........................................................
TABLE OF CONTENTS
1-14
1-15
1-16
1-17
1-18
1-20
1-21
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Part 2 General Operations A step by step walk through of the operations...........
that support the running and processing of
the tests.
Administration Setup
Administration Setup Overview
Administration Setup
User Setup
User Setup Overview
User Setup
Model Selection
Model Selection Overview
Model Selection...................................................
Priming
Priming Overview ................................................
...........................................
..........................................
..........................................................
...........................
...................................
2-1
2-2
2-3
2-9
2-10
2-16
2-18
2-23
Priming ...............
Purging
Purging Overview
Purging
Datalog
Datalog Overview
Printing Reports
Printing Reports Overview
Automatically Printing Reports............................
Manually Printing Reports Overview....................
Manually Printing Reports....................................
................................................................
................................................
................................................
................................................
..................................
2-25
2-28
2-29
2-31
2-33
2-34
2-35
2-36
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TABLE OF CONTENTS
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System Memory Overview ...................................
Alarm Overview
Flash
Flash Overview
Flashing Files
.......................................................
.
..................................................
.
.....................................................
2-38
2-39
2-42
2-44
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TABLE OF CONTENTS
INTRODUCTIONINTRODUCTION
INTRODUCTION
INTRODUCTIONINTRODUCTION
Part 3 Infusion Analyzer--Flow Mode A step by step walk through of ................
running an Infusion Analyzer
Flow or Flow--PCA test.
Infusion Analyzer--Flow
Flow Test Overview
Getting Ready for a Flow Test.............................
Running a Flow Test............................................
Datalog Sample for Flow Test.............................
Infusion Analyzer--Flow--PCA
Flow--PCA Test Overview
Getting Ready for a Flow--PCA Test
Running a Flow--PCA Test..................................
Datalog Sample for Flow--PCA Test
Datalog--Flow Test
.............................................
...................................
...................
..................
3-1
3-2
3-4
3-6
3-8
3-9
3-11
3-13
3-16
Flow Test Datalog Overview................................
Flow Test Datalog................................................
3-17
3-18
vii
TABLE OF CONTENTS
INTRODUCTIONINTRODUCTION
INTRODUCTION
INTRODUCTIONINTRODUCTION
Part 4 Infusion Analyzer--Occlusion Mode A step by step walk through..........
of running a Distal or Proximal
Occlusion test.
Infusion Analyzer--Distal Occlusion
Distal Occlusion Test Overview
Getting Ready for a Distal Occlusion Test
Running a Distal Occlusion Test.........................
Datalog Sample for a Distal Occlusion Test
Infusion Analyzer--Proximal Occlusion
Proximal Occlusion Test Overview
Getting Ready for a Proximal Occlusion Test
Running a Proximal Occlusion Test....................
Datalog--Occlusion
Occlusion Test Datalog Overview .......................
..........................
..........
.......
.....................
.....
4-1
4-2
4-4
4-6
4-8
4-9
4-10
4-11
4-12
Occlusion Test Datalog.......................................
4-13
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TABLE OF CONTENTS
INTRINTR
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Part 5 Safety Analyzer--Manual Mode A step by step walk through of ...............
running a Manual Safety
Analyzer test.
Safety Analyzer--Manual Mode
Manual Test Overview
Getting Ready for a Manual Test
Running a Manual Test........................................
.........................................
.........................
Part 6 Safety Analyzer--Automatic Mode A step by step walk through ............
of running an Automatic Safety
Analyzer test.
Safety Analyzer--Automatic Mode
Automatic Test Overview.........................
Getting Ready for an Automatic Test.......
5-1
5-2
5-3
5-4
6-1
6-2
6-3
Running an Automatic Test .....................
Datalog Sample for an Automatic Test....
Datalog--Safety Analyzer
Safety Analyzer Datalog Overview ......................
Safety Analyzer Datalog......................................
6-4
6-15
6-16
6-17
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TABLE OF CONTENTS
This Page Intentionally Left Blank.
x
ABOUT ABOUT
ABOUT
ABOUT ABOUT
PART 1 : ABOUT THE IPA-2000 Series
THE IPTHE IP
THE IP
THE IPTHE IP
A-2000 SERIESA-2000 SERIES
A-2000 SERIES
A-2000 SERIESA-2000 SERIES
The IPA-2000S is an Infusion Pump Analyzer that can perform
Flow, Flow--PCA, Distal Occlusion and Proximal Occlusion
tests. Also included is a built-in Safety Analyzer that can be
run manually or automatically, greatly simplifying the testing
process.
There can be up to two Infusion Pump test modules connected
to the main unit. These Interface Modules are totally
interchangeable and may plug into either of the two inputs. The
unit automatically senses the interface modules and their
locations. It will then configure the system accordingly.
There are provisions for a keyboard, a printer and a serial
communications cable on the back of the unit. These allow for
1-1
keyboard data entry, printing of reports, downloading of data
and uploading of programs.
PART 1 : ABOUT THE IPA-2000 SERIES
ABOUT ABOUT
ABOUT
ABOUT ABOUT
THE IPTHE IP
THE IP
THE IPTHE IP
A-2000 SERIESA-2000 SERIES
A-2000 SERIES
A-2000 SERIESA-2000 SERIES
The IPA-2000 is an Infusion Pump Analyzer that can perform
Flow, Flow--PCA, Distal Occlusion and Proximal Occlusion
tests. Portions of this manual dealing with the Safety Analyzer
are not applicable to this unit.
There can be up to two Infusion Pump test modules connected
to the main unit. These Interface Modules are totally
interchangeable and may plug into either of the two inputs. The
unit automatically senses the interface modules and their
locations. It will then configure the system accordingly.
There are provisions for a keyboard, a printer and a serial
communications cable on the back of the unit. These allow for
keyboard data entry, printing of reports, downloading of data
and uploading of programs.
1-2
PART 1 : ABOUT THE IPA-2000 SERIES
INFUSION PUMP INFUSION PUMP
INFUSION PUMP
INFUSION PUMP INFUSION PUMP
INFUSION PUMP ANALYZER OVERVIEW
ANAN
AN
ANAN
ALAL
YZER OYZER O
AL
YZER O
ALAL
YZER OYZER O
VERVER
VER
VERVER
The Infusion Pump Analyzer is used to monitor the flow and
pressure of the fluid moving through a pump. There are four
tests within the Infusion Pump Analyzer: Flow, Flow--PCA, Distal
Occlusion and Proximal Occlusion. Fully configured with two
interface modules, the system can run two independent
channels, with any combination of tests active.
The Flow test records elapsed time, average flow, instantaneous
flow, volume and pressure at data points and reports the average
VIEWVIEW
VIEW
VIEWVIEW
flow, total volume, elapsed time and back pressure at the
conclusion of the test. The Flow--PCA test adds a connection
for the module to simulate patient request when there is no flow.
The Flow--PCA test records all the aforementioned information
as well as additional Bolus data and lockout times, average Bolus
flow, average Bolus volume, average lockout time and number
of deliveries.
The Distal Occlusion test records time and pressure and gives
the maximum pressure and its time. The Proximal Occlusion
test is a convenient timer to use when performing the Proximal
test manually on the DUT.
1-3
INFUSION PUMP ANALYZER OVERVIEW
SAFETY SAFETY
SAFETY
SAFETY SAFETY
SAFETY ANALYZER OVERVIEW
ANAN
AN
ANAN
ALAL
YZER OYZER O
AL
YZER O
ALAL
YZER OYZER O
VERVER
VER
VERVER
The Safety Analyzer is used to check the electrical current going
through and leaking from the Device Under Test (DUT).
The Safety Analyzer can be run manually or automatically. In the
manual mode, the settings for leakage type, polarity and the hot
and neutral leads are manipulated using the Manual Safety
Analyzer keypad on the unit.
In the automatic mode, the system will perform all of the required
VIEWVIEW
VIEW
VIEWVIEW
test combinations with the DUT both on and off and record all of
the data. It will then report the maximum normal and fault leakage
currents for both Chassis and Ground leakage, as well as the
method that produced the maximum current measurement.
The limits for the Ground Resistance and Leakage Current
measurements can be selected as AAMI, Custom or IEC.
1-4
SAFETY ANALYZER OVERVIEW
INSTRINSTR
INSTR
INSTRINSTR
INSTRUMENT PHYSICAL OVERVIEW
UMENT OUMENT O
UMENT O
UMENT OUMENT O
This section gives a pictorial overview of the system.
Included are:
CMain Unit Front Panel pictorial with details
CMain Unit Specific Keypad details
CMain Unit Rear Panel pictorial with details
CModule Front Panel pictorial with details
CModule Rear Panel pictorial with details
VERVER
VER
VERVER
VIEWVIEW
VIEW
VIEWVIEW
CCommercial and Main Screens
1-5
INSTRUMENT PHYSICAL OVERVIEW
INSTRINSTR
INSTR
INSTRINSTR
UNIT FRONT-PANEL
UMENT OUMENT O
UMENT O
UMENT OUMENT O
VERVER
VER
VERVER
VIEWVIEW
VIEW
VIEWVIEW
Display window that
shows needed
information concerning
tests and data.
Audio Transducer that
provides key clicks,
warning and alarm tones
(behind faceplate)
Keypad for use during
Manual Safety
Analyzer test.
Keypad for setup,
running of tests, data
processing and printing.
Light Emitting Diodes
(LEDs) that indicate
the status of the line
powering the unit.
1-6
Stud used when
zeroing the test
lead during a
Safety Analyzer
test.
Test Receptacle Outlet
used to plug in the
Device Under Test (DUT)
power cord during a Safety
Analyzer test.
Banana jack used to
plug in the test lead
during a Safety
Analyzer test.
UNIT FRONT-PANEL
INSTRINSTR
INSTR
INSTRINSTR
UMENT OUMENT O
UMENT O
UMENT OUMENT O
UNIT FRONT-PANEL CONTROLS
VERVER
VER
VERVER
VIEWVIEW
VIEW
VIEWVIEW
Used to scroll up
and down while
viewing data or
selecting various
options.
Used from main screen
to enter setup and edit
modes. Used from test
screens to enter model
selection and edit modes.
Used to browse
and print Datalogs.
Used to toggle
through channels.
1-7
Used to enter edited
choices and return to
view screens.
Used to silence alarms.
Used to start and
stop tests.
UNIT FRONT-PANEL CONTROLS
Toggles the
leakage being
tested between
chassis and
ground.
Momentarily
opens and closes
the ground lead
of the Test
Receptacle outlet.
INSTRINSTR
INSTR
INSTRINSTR
UMENT OUMENT O
UMENT O
UMENT OUMENT O
Opens and closes
the hot lead of the
Test Receptacle
outlet.
VERVER
VER
VERVER
VIEWVIEW
VIEW
VIEWVIEW
Used to zero the
test lead that will
be used to measure
chassis leakage.
Changes the
polarity of the
Test Receptacle
outlet.
Opens and closes
the neutral lead
of the Test
Receptacle outlet.
1-8
UNIT FRONT-PANEL CONTROLS
INSTRINSTR
INSTR
INSTRINSTR
UNIT BACK-PANEL
UMENT OUMENT O
UMENT O
UMENT OUMENT O
VERVER
VER
VERVER
VIEWVIEW
VIEW
VIEWVIEW
1-9
Model / Serial
Number and
barcode for
the unit.
UNIT BACK-PANEL
Status Light Emitting
Diodes (LEDs) that
show power and
normal status.
INSTRINSTR
INSTR
INSTRINSTR
MODULE FRONT-PANEL
UMENT OUMENT O
UMENT O
UMENT OUMENT O
Nurse Call connector
for optional use
during Distal
Occlusion Test.
PCA connector
for use during
Flow-PCATest.
VERVER
VER
VERVER
VIEWVIEW
VIEW
VIEWVIEW
Luer Lock connector
for Fluid Out drain
tube with 1/4 “ ID and
air vent that goes to
drainage container.
1-10
Luer Lock connector
for Inlet Valve for
Fluid In tube that
comes from
DUT out.
MODULE FRONT-PANEL
INSTRINSTR
INSTR
INSTRINSTR
UMENT OUMENT O
UMENT O
UMENT OUMENT O
VERVER
VER
VERVER
VIEWVIEW
VIEW
VIEWVIEW
MODULE BACK-PANEL
Threaded holes
for optional pole
mounting
bracket.
Model / Serial
Number and
barcode for
the unit.
Connection for
DB15 cable to
unit.
1-11
Threaded hole
on bottom for
optional stand.
MODULE BACK-PANEL
COMMERCIAL AND MAIN SCREENS
NOTES:
CThe Commercial screen displays
while the system is initiating.
CThe unit model and program version
appear on this screen.
NOTES:
CThe Main screen displays after
approximately 3 seconds.
CFrom this screen, central access
to the Datalogger can be obtained
with or without modules attached,
current active alarms may be
viewed, the Setup mode can be
accessed and test screens can be
toggled to.
CThe Display key is used to cycle
back to the Main screen from other
locations.
CThe time of day clock and date
appear on this screen, the format
and value of which can be selected
in User Setup.
INSTRINSTR
INSTR
INSTRINSTR
INFUSION ANALYZER
MODEL IPA-2000S
Month Day, Year
UMENT OUMENT O
UMENT O
UMENT OUMENT O
BC GROUP
VER X.X
IPA-2000S
00:00:00
VERVER
VER
VERVER
VIEWVIEW
VIEW
VIEWVIEW
1-12
COMMERCIAL AND MAIN SCREENS
CONNECTIONSCONNECTIONS
CONNECTIONS
CONNECTIONSCONNECTIONS
CONNECTIONS OVERVIEW
This section gives a pictorial overview and explanation of
connections for the unit and modules.
Included are:
CMain Unit to Module connection
CMain Unit to Printer connection
CMain Unit to Keyboard connection
CMain Unit Computer connection
CSystem to DUT for Infusion Pump Analysis
CSystem to DUT for Safety Analysis
1-13
CONNECTIONS OVERVIEW
MODULE CONNECTION
CONNECTIONSCONNECTIONS
CONNECTIONS
CONNECTIONSCONNECTIONS
1-14
CModules are connected during use of the Infusion Analyzer.
CA module is connected using a DB15 cable from the port on the back of the
module to one of the Channel ports on the back of the unit.
CModules are interchangeable and can be connected to either Channel 1 or 2.
MODULE CONNECTION
PRINTER CONNECTION
CONNECTIONSCONNECTIONS
CONNECTIONS
CONNECTIONSCONNECTIONS
1-15
CAny standard printer can be connected to the unit using a Centronics
parallel cable (IEEE-1284).
CThe printer is connected from the parallel port of the printer to the parallel
port of the unit.
C A serial printer can also be connected to the unit using an RS232 cable
(DB9) .
CThe printer is connected from the serial port of the printer to the serial port
of the unit.
C(See PRINTING REPORTS for details on how to print.)
PRINTER CONNECTION
KEYBOARD CONNECTION
CONNECTIONSCONNECTIONS
CONNECTIONS
CONNECTIONSCONNECTIONS
1-16
CAny PS/2 style keyboard can be connected to the unit.
CThe keyboard cable is connected to the PS/2 port of the unit.
C(Optional) Labels for the keyboard illustrate how the Function and Arrow
keys correspond to the controls on the unit.
CFull remote control of the unit can be obtained through use of the keyboard.
CThe standard keys can then be used to type in Manufacturer, Model, S/N,
Department and Location to help identify tests in the Datalogger and printouts.
(See MODEL SELECTION for details.)
KEYBOARD CONNECTION
COMPUTER CONNECTION
CONNECTIONSCONNECTIONS
CONNECTIONS
CONNECTIONSCONNECTIONS
1-17
CAn RS232 cable (DB9) can be used to interface the unit with a computer.
CThe RS232 cable is connected from a communication port on the computer
to the Serial Port on the unit.
CThe RS232 connection can be utilized to download reports from the unit.
CThe RS232 connection can be utilized to load updated programs to the
unit. (See FLASH for details.)
COMPUTER CONNECTION
CONNECTIONSCONNECTIONS
CONNECTIONS
CONNECTIONSCONNECTIONS
INFUSION PUMP ANALYZER / DUT CONNECTION
1-18
CFor Infusion Analyzer Tests, the following connections must be made:
CInterface module to unit
CFluid source to device under test (DUT)
CInlet Valve to module Fluid In
CDUT Fluid Out to Inlet Valve
CModule Fluid Out 1/4” ID Drain Tube with air vent
to drainage container
CDUT power cord to Unit receptacle
CUnit power cord to wall receptacle
INFUSION PUMP ANALYZER / DUT CONNECTION
CONNECTIONSCONNECTIONS
CONNECTIONS
CONNECTIONSCONNECTIONS
1-19
CFor Infusion Analyzer Tests, the following module connections must be made:
CInlet Valve to module Fluid In
CDUT Fluid Out to Inlet Valve
CModule Fluid Out 1/4” ID Drain Tube with air vent
to drainage container
INFUSION PUMP ANALYZER / DUT CONNECTION
SAFETY ANALYZER / DUT CONNECTION
CONNECTIONSCONNECTIONS
CONNECTIONS
CONNECTIONSCONNECTIONS
1-20
CFor Safety Analyzer Tests, the following connections must be made:
CTest lead into banana jack on unit.
CTest lead hooked to chassis of device under test (DUT)
(See Pump Manufacturer Manual for requirements or special
instructions for placement.)
CDUT power cord to Unit receptacle
CUnit power cord to wall receptacle
SAFETY ANALYZER / DUT CONNECTION
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