BC Biomedical IPA-2000 User manual

i
User Manual
Manual 2000S01
Copyright © 2002
Revision 8
October 2003
IPA-2000S
Infusion Pump Analyzer
with Safety Analyzer
IPA-2000
Infusion Pump Analyzer

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LIMITED WARRANTY
NOTICES
INTRINTR
INTRINTR
INTRODUCTIONODUCTION
ODUCTIONODUCTION
ODUCTION
NOTICES
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.
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.

iii
PRODUCTS COVERED BY MANUAL
INTRODUCTIONINTRODUCTION
INTRODUCTIONINTRODUCTION
INTRODUCTION
NOTICES
This manual gives a comprehensive overview of all the available features for the IPA-
2000 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

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TABLE OF CONTENTS
INTRINTR
INTRINTR
INTRODUCTIONODUCTION
ODUCTIONODUCTION
ODUCTION
TABLE OF CONTENTS
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
- Panel...................................................
Unit Front
- Panel Controls....................................
Unit Back
- Panel...................................................
Module
Front - Panel.............................................
Module Back
- Panel . .............................................
Commercial and Main Screen
. ............................
Connections
Connections Overview
. ........................................
Module Connection
. .............................................
Printer Connection
. ..............................................
Keyboard Connection
. ..........................................
Computer Connection..........................................
Infusion Pump Analyzer
/ DUT Connection . ........
Safety Analyzer
/ DUT Connection . .....................
Specifications
. ...........................................................
1-1
1-3
1-4
1-5
1-6
1-7
1-9
1-10
1-11
1-12
1-13
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 ................................................
Priming ...............
................................................
Purging
Purging Overview
................................................
Purging
................................................................
Datalog
Datalog Overview
................................................
Printing Reports
Printing Reports Overview
..................................
Automatically Printing Reports............................
Manually Printing Reports Overview....................
Manually Printing Reports....................................
INTRINTR
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INTRODUCTIONODUCTION
ODUCTIONODUCTION
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2-1
2-2
2-3
2-9
2-10
2-16
2-18
2-23
2-25
2-28
2-29
2-31
2-33
2-34
2-35
2-36
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vi
System Memory Overview ...................................
Alarm Overview
.......................................................
Flash
Flash Overview
. ..................................................
Flashing Files
. .....................................................
2-38
2-39
2-42
2-44
INTRINTR
INTRINTR
INTRODUCTIONODUCTION
ODUCTIONODUCTION
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TABLE OF CONTENTS

vii
INTRODUCTIONINTRODUCTION
INTRODUCTIONINTRODUCTION
INTRODUCTION
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
Flow Test Datalog Overview................................
Flow Test Datalog................................................
3-1
3-2
3-4
3-6
3-8
3-9
3-11
3-13
3-16
3-17
3-18
TABLE OF CONTENTS

viii
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 .......................
Occlusion Test Datalog.......................................
Part 4 Infusion Analyzer--Occlusion Mode A step by step walk through..........
of running a Distal or Proximal
Occlusion test.
INTRODUCTIONINTRODUCTION
INTRODUCTIONINTRODUCTION
INTRODUCTION
4-1
4-2
4-4
4-6
4-8
4-9
4-10
4-11
4-12
4-13
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ix
Safety Analyzer--Manual Mode
Manual Test Overview
.........................................
Getting Ready for a Manual Test
.........................
Running a Manual Test........................................
Part 5 Safety Analyzer--Manual Mode A step by step walk through of . ..............
running a Manual Safety
Analyzer 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.......
Running an Automatic Test .....................
Datalog Sample for an Automatic Test....
Datalog--Safety Analyzer
Safety Analyzer Datalog Overview ......................
Safety Analyzer Datalog......................................
INTRINTR
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INTRODUCTIONODUCTION
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5-1
5-2
5-3
5-4
6-1
6-2
6-3
6-4
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TABLE OF CONTENTS

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This Page Intentionally Left Blank.

1-1
PART 1 : ABOUT THE IPA-2000 Series
ABOUTABOUT
ABOUTABOUT
ABOUT THE IPTHE IP
THE IPTHE IP
THE IPA-2000 SERIESA-2000 SERIES
A-2000 SERIESA-2000 SERIES
A-2000 SERIES
PART 1 : ABOUT THE IPA-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
keyboard data entry, printing of reports, downloading of data
and uploading of programs.

1-2
ABOUTABOUT
ABOUTABOUT
ABOUT THE IPTHE IP
THE IPTHE IP
THE IPA-2000 SERIESA-2000 SERIES
A-2000 SERIESA-2000 SERIES
A-2000 SERIES
PART 1 : ABOUT THE IPA-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.

1-3
INFUSION PUMP ANALYZER OVERVIEW
INFUSION PUMPINFUSION PUMP
INFUSION PUMPINFUSION PUMP
INFUSION PUMP ANAN
ANAN
ANALAL
ALAL
ALYZER OYZER O
YZER OYZER O
YZER OVERVER
VERVER
VERVIEWVIEW
VIEWVIEW
VIEW
INFUSION PUMP ANALYZER OVERVIEW
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
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.

1-4
SAFETY ANALYZER OVERVIEW
SAFETYSAFETY
SAFETYSAFETY
SAFETY ANAN
ANAN
ANALAL
ALAL
ALYZER OYZER O
YZER OYZER O
YZER OVERVER
VERVER
VERVIEWVIEW
VIEWVIEW
VIEW
SAFETY ANALYZER OVERVIEW
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
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.

1-5
INSTRUMENT PHYSICAL OVERVIEW
INSTRINSTR
INSTRINSTR
INSTRUMENT OUMENT O
UMENT OUMENT O
UMENT OVERVER
VERVER
VERVIEWVIEW
VIEWVIEW
VIEW
INSTRUMENT PHYSICAL OVERVIEW
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
CCommercial and Main Screens

1-6
UNIT FRONT-PANEL
Light Emitting Diodes
(LEDs) that indicate
the status of the line
powering the unit.
Banana jack used to
plug in 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.
INSTRINSTR
INSTRINSTR
INSTRUMENT OUMENT O
UMENT OUMENT O
UMENT OVERVER
VERVER
VERVIEWVIEW
VIEWVIEW
VIEW
UNIT FRONT-PANEL
Display window that
shows needed
information concerning
tests and data.
Keypad for setup,
running of tests, data
processing and printing.
Stud used when
zeroing the test
lead during a
Safety Analyzer
test.
Keypad for use during
Manual Safety
Analyzer test.
Audio Transducer that
provides key clicks,
warning and alarm tones
(behind faceplate)

1-7
UNIT FRONT-PANEL CONTROLS
UNIT FRONT-PANEL CONTROLS
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.
Used to scroll up
and down while
viewing data or
selecting various
options.
Used to enter edited
choices and return to
view screens.
Used to silence alarms.
Used to start and
stop tests.
INSTRINSTR
INSTRINSTR
INSTRUMENT OUMENT O
UMENT OUMENT O
UMENT OVERVER
VERVER
VERVIEWVIEW
VIEWVIEW
VIEW

1-8 UNIT FRONT-PANEL CONTROLS
Momentarily
opens and closes
the ground lead
of the Test
Receptacle outlet.
Toggles the
leakage being
tested between
chassis and
ground.
Opens and closes
the hot lead of the
Test Receptacle
outlet.
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.
INSTRINSTR
INSTRINSTR
INSTRUMENT OUMENT O
UMENT OUMENT O
UMENT OVERVER
VERVER
VERVIEWVIEW
VIEWVIEW
VIEW

1-9
UNIT BACK-PANEL
UNIT BACK-PANEL
INSTRINSTR
INSTRINSTR
INSTRUMENT OUMENT O
UMENT OUMENT O
UMENT OVERVER
VERVER
VERVIEWVIEW
VIEWVIEW
VIEW
Model / Serial
Number and
barcode for
the unit.

1-10
MODULE FRONT-PANEL
MODULE FRONT-PANEL
Nurse Call connector
for optional use
during Distal
Occlusion Test.
PCA connector
for use during
Flow-PCATest.
Status Light Emitting
Diodes (LEDs) that
show power and
normal status.
Luer Lock connector
for Fluid Out drain
tube with 1/4 “ ID and
air vent that goes to
drainage container.
Luer Lock connector
for Inlet Valve for
Fluid In tube that
comes from
DUT out.
INSTRINSTR
INSTRINSTR
INSTRUMENT OUMENT O
UMENT OUMENT O
UMENT OVERVER
VERVER
VERVIEWVIEW
VIEWVIEW
VIEW