IDA-5
Infusion Device Analyzer
PN FBC-0039
April 2013, Rev. 2, 10/14
© 2013-2014 Fluke Corporation. All rights reserved. Specifications are subject to change without notice.
All product names are trademarks of their respective companies.
Users Manual
Warranty and Product Support
Fluke Biomedical warrants this instrument against defects in materials and workmanship for one year from
the date of original purchase OR two years if at the end of your first year you send the instrument to a
Fluke Biomedical service center for calibration. You will be charged our customary fee for such calibration.
During the warranty period, we will repair or at our option replace, at no charge, a product that proves to be
defective, provided you return the product, shipping prepaid, to Fluke Biomedical. This warranty covers the
original purchaser only and is not transferable. The warranty does not apply if the product has been
damaged by accident or misuse or has been serviced or modified by anyone other than an authorized
Fluke Biomedical service facility. NO OTHER WARRANTIES, SUCH AS FITNESS FOR A PARTICULAR
PURPOSE, ARE EXPRESSED OR IMPLIED. FLUKE SHALL NOT BE LIABLE FOR ANY SPECIAL,
INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES OR LOSSES, INCLUDING LOSS OF DATA,
ARISING FROM ANY CAUSE OR THEORY.
This warranty covers only serialized products and their accessory items that bear a distinct serial number
tag. Recalibration of instruments is not covered under the warranty.
This warranty gives you specific legal rights and you may also have other rights that vary in different
jurisdictions. Since some jurisdictions do not allow the exclusion or limitation of an implied warranty or of
incidental or consequential damages, this limitation of liability may not apply to you. If any provision of this
warranty is held invalid or unenforceable by a court or other decision-maker of competent jurisdiction, such
holding will not affect the validity or enforceability of any other provision.
7/07
Notices
All Rights Reserved
Copyright 2014, Fluke Biomedical. No part of this publication may be reproduced, transmitted, transcribed, stored in a
retrieval system, or translated into any language without the written permission of Fluke Biomedical.
Copyright Release
Fluke Biomedical agrees to a limited copyright release that allows you to reproduce manuals and other printed materials
for use in service training programs and other technical publications. If you would like other reproductions or distributions,
submit a written request to Fluke Biomedical.
Unpacking and Inspection
Follow standard receiving practices upon receipt of the instrument. Check the shipping carton for damage. If damage is
found, stop unpacking the instrument. Notify the carrier and ask for an agent to be present while the instrument is
unpacked. There are no special unpacking instructions, but be careful not to damage the instrument when unpacking it.
Inspect the instrument for physical damage such as bent or broken parts, dents, or scratches.
Technical Support
For application support or answers to technical questions, either email techservices@flukebiomedical.com or call
1-800-850-4608 or 1-440-248-9300. In Europe, email techsupport.emea@flukebiomedical.com or call +31-40-2965314.
Claims
Our routine method of shipment is via common carrier, FOB origin. Upon delivery, if physical damage is found, retain all
packing materials in their original condition and contact the carrier immediately to file a claim. If the instrument is delivered
in good physical condition but does not operate within specifications, or if there are any other problems not caused by
shipping damage, please contact Fluke Biomedical or your local sales representative.
Returns and Repairs
Return Procedure
All items being returned (including all warranty-claim shipments) must be sent freight-prepaid to our factory location. When
you return an instrument to Fluke Biomedical, we recommend using United Parcel Service, Federal Express, or Air Parcel
Post. We also recommend that you insure your shipment for its actual replacement cost. Fluke Biomedical will not be
responsible for lost shipments or instruments that are received in damaged condition due to improper packaging or
handling.
Use the original carton and packaging material for shipment. If they are not available, we recommend the following guide
for repackaging:
Use a double–walled carton of sufficient strength for the weight being shipped.
Use heavy paper or cardboard to protect all instrument surfaces. Use nonabrasive material around all
projecting parts.
Use at least four inches of tightly packed, industry-approved, shock-absorbent material around the
Returns for partial refund/credit:
Every product returned for refund/credit must be accompanied by a Return Material Authorization (RMA) number,
obtained from our Order Entry Group at 1-440-498-2560.
Repair and calibration:
To find the nearest service center, go to www.flukebiomedical.com/service or
In the U.S.A.:
Cleveland Calibration Lab
Tel: 1-800-850-4608 x2564
Email: globalcal@flukebiomedical.com
instrument.
In Europe, Middle East, and Africa:
Eindhoven Calibration Lab
Tel: +31-40-2675300
Email: ServiceDesk@fluke.com
Everett Calibration Lab
Tel: 1-888-99 FLUKE (1-888-993-5853)
Email: service.status@fluke.com
To ensure the accuracy of the Product is maintained at a high level, Fluke Biomedical recommends the product
be calibrated at least once every 12 months. Calibration must be done by qualified personnel. Contact your local
Fluke Biomedical representative for calibration.
In Asia:
Everett Calibration Lab
Tel: +425-446-6945
Email: service.international@fluke.com
Certification
This instrument was thoroughly tested and inspected. It was found to meet Fluke Biomedical’s manufacturing
specifications when it was shipped from the factory. Calibration measurements are traceable to the National Institute of
Standards and Technology (NIST). Devices for which there are no NIST calibration standards are measured against inhouse performance standards using accepted test procedures.
WARNING
Unauthorized user modifications or application beyond the published specifications may result in electrical shock hazards
or improper operation. Fluke Biomedical will not be responsible for any injuries sustained due to unauthorized equipment
modifications.
Restrictions and Liabilities
Information in this document is subject to change and does not represent a commitment by Fluke Biomedical.
Changes made to the information in this document will be incorporated in new editions of the publication. No
responsibility is assumed by Fluke Biomedical for the use or reliability of software or equipment that is not
supplied by Fluke Biomedical, or by its affiliated dealers.
Manufacturing Location
The IDA-5 Infusion Device Analyzer is manufactured at Fluke Biomedical, 6920 Seaway Blvd., Everett, WA,
U.S.A.
Table of Contents
Title Page
Introduction ............................................................................................ 1
Intended Use ......................................................................................... 1
Unpack the Product ............................................................................... 1
Safety Information ................................................................................. 2
Symbols ................................................................................................. 4
Instrument Familiarization ..................................................................... 5
Product Connections ............................................................................. 7
Connect Infusion Devices .................................................................. 7
Connect Drains to the Product .......................................................... 8
Connect Accessories ............................................................................. 8
Keyboard ........................................................................................... 9
Bar Code Reader ............................................................................... 9
Printer ................................................................................................ 9
Product Operation ................................................................................. 9
Preferences ....................................................................................... 10
How to Test Infusion Devices ............................................................ 11
Flow Tests ............................................................................................. 14
Occlusion Tests ..................................................................................... 18
How to Test PCA Pumps ....................................................................... 21
Dual Flow Pump Test ............................................................................ 23
Templates .............................................................................................. 23
Define a Template ............................................................................. 24
Template Operation ........................................................................... 25
Utilities ................................................................................................... 26
Recall Tests ....................................................................................... 26
Set Clock ....................................................................................... 27
User Preferences ........................................................................... 27
Printer Setup/Test .......................................................................... 27
Cancel Print ................................................................................... 27
Instructions ........................................................................................ 27
Report Header ............................................................................... 27
Default Test Preferences ............................................................... 27
Calibration ......................................................................................... 28
Edit Templates ................................................................................... 28
Troubleshooting ..................................................................................... 29
Product Maintenance ............................................................................ 30
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Clean the Product .............................................................................. 30
Outside .......................................................................................... 30
Inside ............................................................................................. 30
Replaceable Parts ............................................................................. 31
Test Fluid ........................................................................................... 32
Storage .............................................................................................. 32
Shipping ............................................................................................. 32
General Specifications .......................................................................... 33
Performance Specifications ................................................................... 33
ii
List of Tables
Table Title Page
1. Symbols ..................................................................................................... 4
2. Front-Panel Controls and Connections ..................................................... 5
3. Rear-Panel Controls and Connections ...................................................... 6
4. Channel Setup Screen Controls ................................................................ 11
5. Device Information Fields .......................................................................... 12
6. Device Information Controls ...................................................................... 13
7. Device Detail Information Fields ................................................................ 13
8. Flow Screen Menu Controls ...................................................................... 15
9. Channel Flow Measurement Parameters .................................................. 15
10. Flow Graph Screen Controls ..................................................................... 16
11. Flow Screen in End Mode ......................................................................... 17
12. Occlusion Screen in Start Mode ................................................................ 18
13. Occlusion Screen in Active Mode .............................................................. 19
14. Occlusion Screen in End Mode ................................................................. 20
15. PCA/Dual Information Screen ................................................................... 21
16. PCA Screen in Active Mode ...................................................................... 22
17. Template Detail Screen ............................................................................. 24
18. Recall Tests Screen .................................................................................. 26
19. Bubble Errors ............................................................................................ 29
20. Air Lock Errors ........................................................................................... 29
21. Replaceable Parts ..................................................................................... 31
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List of Figures
Figure Title Page
1. Infusion Device Connections to the Product ............................................. 7
2. Drain Connections to the Product ............................................................. 8
3. Status All Channels ................................................................................... 9
4. Utilities Screen .......................................................................................... 10
5. Channel Flow Screen ................................................................................ 14
6. Channel Flow Graph ................................................................................. 16
7. Occlusion Graph Screen ........................................................................... 19
8. PCA Screen - Prime Mode ........................................................................ 22
9. PCA Graph Screen .................................................................................... 23
10. Utilities Menu Screen ................................................................................ 26
11. Default Test Preferences Screen .............................................................. 27
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Introduction
The Fluke Biomedical IDA-5 Infusion Device Analyzer (the Product) is a precision
instrument that examines the performance of medical infusion devices. The
Product measures the flow rate and volume supplied, and the pressure
generated in occlusion or blockages of the fluid line. A maximum of 4 infusion
devices can be independently examined with the four-channel version of the
Product.
Intended Use
The Product is to be used by infusion device manufacturers, hospital biomedical
engineering departments, and third-party service organizations. Use the Product
to verify accurate performance of infusion devices through measurement of flow,
volume, and pressure. The performance of a wide range of infusion devices can
be analyzed including syringe, drop counting, peristaltic, and volumetric types.
Non-steady flow rate pumps can also be analyzed. The Product uses distilled or
deionized water with an optional wetting agent only.
Unpack the Product
Carefully unpack all items from the box and check that these items are included:
• The Product
• Power Cord
• Accessory Set (syringe, stopcocks, drain tubing, and Micro 90
• CD (contains Users Manual and HydroGraph software)
• USB Cable
)
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Safety Information
A Warning identifies hazardous conditions and actions that could cause bodily
harm or death. A Caution identifies conditions and actions that could harm the
Product, the equipment under test, or cause permanent loss of data.
Warning
To prevent possible electrical shock, fire, or personal injury:
• Read all safety information before you use the Product.
• Carefully read all instructions.
• Use the product only as specified, or the protection supplied
by the product can be compromised.
• Do not use the Product if it operates incorrectly.
• Do not use the Product if it is damaged.
• Disable the Product if it is damaged.
• Use this Product indoors only.
• Connect an approved three-conductor mains power cord to
a grounded power outlet.
• Never use a two-prong plug adapter to connect primary
power to the Product.
• Use only the mains power cord and connector approved for
the voltage and plug configuration in your country and rated
for the Product.
• Turn the Product off and remove the mains power cord
before cleaning the outer surface of the Product.
• Make sure the ground conductor in the mains power cord is
connected to a protective earth ground. Disruption of the
protective earth could put voltage on the chassis that could
cause death.
• Replace the mains power cord if the insulation is damaged
or if the insulation shows signs of wear.
• Do not open the Product unless you are qualified.
• Do not use the Product around explosive gas, vapor, or in
damp or wet environments.
• Do not use the Product on infusion devices that are
attached to patients.
2
• Do not reuse test tubing or syringes for patient infusion.
Infusion Device Analyzer
Safety Information
• Avoid possible contamination of reusable components due
to backflow conditions. Some older style infusion devices
may have reusable components that could come in direct
contact with the fluids being pumped. When testing these
types of devices take care to avoid possible contamination
of reusable components.
• Do not use delivery set or components that have been used
for testing for patient infusion.
• Do not connect the Product to a patient or equipment
connected to a patient. The Product is intended for
equipment evaluation only and should never be used in
diagnostics, treatment or in any other capacity where the
Product would come in contact with a patient.
• The Product must be properly earthed. Only use a supply
socket that has a protective earth contact. If there is any
doubt as to the effectiveness of the supply socket earth, do
not connect the Product. Do not use a two-conductor
adapter or extension cord. This will break the protective
ground connection.
• Many components on the printed circuit board are static
sensitive. ESD precautions should be observed when
handling the printed circuit board assembly.
• To avoid shock hazard and for proper Product operation,
connect the factory supplied three-conductor line power
cord to a properly grounded power outlet. Do not use a twoconductor adapter or extension cord; this will break the
protective ground connection.
• The Product is intended for use by trained service
technicians to perform periodic inspections on a wide range
of medical equipment. The testing procedures are menudriven and simple to operate.
• The Product is intended for use with single-phase, grounded
power. It is not intended for dual, split-phase or three-phase
power configurations. But it can be used with any power
system that supplies the correct voltages for single-phase
and is grounded.
• This Product is intended to be used in the laboratory
environment, outside of the patient care area, and is not
intended for use on patients, or to test devices while
connected to patients. This Product is not intended to be
used to calibrate medical equipment and not intended for
over the counter use.
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Caution
To prevent possible damage to the product or to equipment
under test:
• Only qualified service personnel should service the Product.
• Only qualified technical personnel should perform
troubleshooting and service procedures on internal
components.
• Only use degassed de-ionized water with the Product.
Wetting agent may be added.
• Do not use high-viscosity fluids. Oils (solvents, or strong
chemicals) may also damage or contaminate the Product.
• Do not use "Bleach" sterilizing agents or alcohols.
• Do not rapidly switch the Product On or Off, nor remove the
line cord while energized.
• Remove internal water before shipping or storing. Do not
use compressed air to clean out the Product.
• Do not expose the Product to temperature extremes. For
proper operation, ambient temperatures should be from
15 °C to 30 °C (59 °F to 86 °F). Performance may be
adversely affected if temperatures fluctuate above or below
this range. For Storage Temperature limits, see the
Specifications section.
• Do not use the Product in close proximity to sources of
strong electromagnetic radiation (e.g., unshielded
intentional RF sources). These sources may interfere with
proper operation.
Symbols
Table 1 is a list of symbols used on the Product and in this document.
Table 1. Symbols
Symbol Description Symbol Description
Risk of Danger. Important
information. See Manual.
Conforms to European Union
directives.
CAT II
Hazardous voltage. Risk of electric shock.
Measurement category II is applicable to
test and measuring circuits connected
directly to utilization points of low voltage
mains installation.
4
This product complies with the WEEE Directive (2002/96/EC) marking requirements. The
affixed label indicates that you must not discard this electrical/electronic product in domestic
household waste. Product Category: With reference to the equipment types in the WEEE
Directive Annex I, this product is classed as category 9 "Monitoring and Control
Instrumentation” product. Do not dispose of this product as unsorted municipal waste. Go to
Fluke’s website for recycling information.
Infusion Device Analyzer
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Instrument Familiarization
Instrument Familiarization
Tables 2 and 3 tell you about the controls and connections on the front and rear
panels of the Product.
Table 2. Front-Panel Controls and Connections
1
2
3
4
5
6
ir01.eps
Item Description
Display (LCD)
Power on indicator
ESC (escape) button – Moves back one step or does the operation given on the display.
ENTER button – Operates the highlighted function or moves to the subsequent data-entry field.
Arrow buttons – Moves the highlight on menus in the direction of the arrow or operates the
function shown on the display.
Flow inlet ports – One port for each measurement channel.
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Table 3. Rear-Panel Controls and Connections
1
2
3
4
5
6
7
ir02.eps
Item Description
Handle
Power switch
Power inlet
Equipotential post
USB “B” connector – Computer connection.
USB “A” connectors – Connect a maximum of four accessories such as:
Keyboard
Printer
Bar-Code reader
Fluid outlets – One per measurement channel. Channel 1 at right and channel 4 at left.
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Infusion Device Analyzer
Product Connections
Product Connections
The Product connects to infusion devices through the front-panel inlet ports. Fluid
drain hoses and accessories connections are made through the rear-panel
connections.
Connect Infusion Devices
As shown in Figure 1, it is recommended that all infusion device connections be
made to the Product front-panel inlet connectors through 3-way stopcocks.
20 ml Syringe
to aid priming
3-way Stopcock
From Infusion
Pumps
gir03.eps
Figure 1. Infusion Device Connections to the Product
The channel 4 inlet shown in Figure 1, shows a 20 ml syringe attached to one
3-way stopcock inlet. The syringe can be used to help priming. It can be used as
shown or can be connected further away from the inlet to help for flow tests. The
syringe can be shared among the channels and removed after the channel is
primed.
Follow these recommendations when you connect to the inlet tubing circuits:
• Use adequate prime volumes (for example, 10 ml) to push through any
bubbles.
• Use the stopcocks at the inlet to prevent fluid backflow out of inlets between
tests.
• When you connect to the inlet circuits (for example, when you attach the
priming syringes to the stopcocks) make sure no new bubbles are
introduced.
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Caution
Do not use delivery set or components that have been used for
prior testing for patient infusion.
Note
Before you use the delivery set (tubing, syringe, etc.), make sure it is
within the specified use period of the manufacturer. Many sets are
made to be used only once.
Connect Drains to the Product
Figure 2 shows tubing connected to the rear-panel outlets of the Product.
Figure 2. Drain Connections to the Product
When you connect drain tubing to the Product outlets:
• Connect different drain tubes to each channel.
• Do not connect the drain tubes together.
• The drain tubes should not be allowed to rise more than 10 cm (4 in) at any
point above the height of the inlet ports of the Product.
• The discharge end of the drain tubes must not be more than 10 cm (4 in)
below the bottom of the Product.
Connect Accessories
Accessories connect to any of the four USB “A” ports on the rear-panel of the
Product. Use a USB cable that is less than 3 meters long.
Connect all USB accessories after the Product is turned on. When
an accessory is connected to a Product that is ON, some seconds
are necessary before the accessory is recognized.
Note
gir04.eps
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Infusion Device Analyzer
Product Operation
Keyboard
It is recommended that a small footprint USB keyboard be used with the Product.
The keyboard is necessary to record data about the infusion device under test.
Note
The keyboard must not have an internal USB hub (for example, no
extra USB ports).
Bar Code Reader
A bar code reader can also be used to scan infusion device data into the
Product.
Printer
A printer that supports PCL-5 (or higher) printer-command language can be used
with the Product to print test results and reports.
Product Operation
Before you turn on the Product, make sure the Product calibration is up-to-date
and check for signs of wear.
The Product power switch is on the rear panel.
To turn on the product and display the Status All Channels screen:
1. Push the power switch. If the Status All Channels screen in Figure 3 shows
without errors, the Product is ready to use.
Status All Channels
Channel 1 Channel 2 Channel 3 Channel 4
00: 00:00 00: 00:00 00: 00:00 00: 00:00
SETUP SETUP SETUP SETUP
FLOW FLOW FLOW FLOW
OCCL OCCL OCCL OCCL
Press ESC for Utilities
Figure 3. Status All Channels
gir05.eps
2. Control the Product with the four arrow buttons and the ENTER and ESC
(Escape) buttons on the front panel:
• Four Arrows move the highlight between menu options.
• ENTER operates the highlighted option.
• ESC functionality is described on the bottom of each screen.
Note
The Arrow, Enter, and Esc buttons of a connected keyboard
replicate the front-panel buttons.
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Preferences
To set your personal preferences, use the Utilities menu. To access this menu,
select ESC while the Status All Channels screen is shown. The Utilities menu in
Figure 4 lets you set user preferences such as LCD brightness, beeper volume,
time and date, test preferences, and lets you record text to use as a header of all
reports. To read more about these preferences and the other features that are
controlled through the Utilities menu, go to the “Utilities” section later in this
manual.
Utilities
Recall Tests Instructions
Set Clock Report Header
User Preferences Test Preferences
Printer Setup/Test Calibration
Cancel Print Edit Templates
Press ESC for Status Screen
Figure 4. Utilities Screen
gir22.eps
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Infusion Device Analyzer
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Product Operation
How to Test Infusion Devices
When you test an infusion device, it is recommended that you record the details
of the device you are testing and the test parameters. From the Status All
Channels screen, select SETUP for the relevant channel. These examples use
channel 1.
The Channel 1 Setup screen described in Table 4 is shown.
Table 4. Channel Setup Screen Controls
Channel 1 Setup
Device Information
Template
Occlusion
Flow
PCA/Dual Flow
Press ESC for Status Screen
Control Description
ir06.eps
Device Information Shows a screen that lets you record infusion device data and test details.
Template Shows a screen that lets you set a template to control a sequence of tests.
Occlusion Occlusion test without details.
Flow Flow test without details.
PCA/Dual Flow
PCA or dual flow test without details – asks for necessary PCA/dual flow
parameters.
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Select Device Information to record data for the test. The Device Information
screen discussed in Table 5 is shown. Initially, only the fields in the top-half of the
screen can be seen. Record the applicable data in the fields and push ENTER to
accept the value and move to the subsequent field.
Table 5. Device Information Fields
Device Information Channel 1
Control No
Operator
Flow Rate Tolerance %
Volume Duration
When Volume reached Notify Operator
Manufacturer
Device Type
Serial Num.
Location
Comments
Press ENTER for next field
Press ESC for previous field
Field Description
ir07.eps
Control Number
Operator
An alpha-numeric code to identify the instrument you will test. This field cannot be
empty.
The name, initials, or identification code of the person who will do the test. This field
cannot be empty.
Flow Rate The set flow rate of the infusion device.
Sets error bars on the flow graph. The error bars can be the permitted flow
Tolerance
performance tolerance of the infusion device that you test. This will default to the
value set on the Default Test Preferences screen (see “Utilities”), but can be
overridden.
Volume
Duration
The amount intended to be supplied. This volume will be used by the test-stop feature
(if enabled).
The intended length of the test. This time will be used by the test-stop feature (if
enabled).
Sets the condition the Product will use to tell you that the test is complete. This will
When
default to the value set on the Default Test Preferences screen (see Utilities), but can
be overridden.
Sets what occurs when the recorded test-stop condition is met. It will default to the
Reached
value set on the Default Test Preferences screen (see Utilities), but can be
overridden.
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Infusion Device Analyzer
Product Operation
When the data fields are filled in, the menu in Table 6 lets you choose what to do
next.
Table 6. Device Information Controls
More Flow Occl PCA Save
Control Description
More Shows the data fields that let you record infusion device data.
Flow Shows the Flow Test screen.
Occl Shows the Occlusion Test start screen.
PCA Shows the PCA Information screen.
Save Disabled during setup.
Menu_bar_1.eps
Select More and then push ENTER to record the infusion device data. Table 7
tells you about these data fields.
Table 7. Device Detail Information Fields
Field Description
Manufacturer The manufacturer of the infusion device under test.
Device Type The model or name of the infusion device.
Serial num The serial number of the infusion device.
Location The usual location of the infusion device.
Comments Other data that could be necessary to record.
After the fields are filled in, the menu in Table 6 shows again but the first menu
selection has changed to Status. Select Status to open the Status All Channels
screen to let other channels to be set up.
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Flow Tests
To do a flow test, select Flow on the menu and then ENTER to open the
Channel Flow screen shown in Figure 5. The screen shown is in Prime mode.
Channel 1 Flow
Average Flow 0.00
Volume 0.00
Elapsed Time 00: 00: 00
Inst. Flow ml/h
Back Pressure mmHg
Prime End
Press ESC for Status Screen
Figure 5. Channel Flow Screen
ml/h
ml
gir08.eps
The vertical bar along the left side of the screen is the Prime indicator of the
liquid in the channel. If there is air in the channel, the indicator will be red. If there
is liquid in the channel, the indicator will be blue. As liquid flows into the channel,
the column changes from red to blue. Red spaces between blue show when the
Product senses bubbles in the measuring system.
When you set up the Product for a flow test, fill the measurement channel with
liquid until the Prime indicator is blue and stays blue. At that time, the Prime
button in the menu at the bottom of the screen changes to AutoStart and a Start
button also appears as shown in Table 8.
Note
The first time a channel is primed after power on, a maximum of
10 ml of liquid can be necessary to fill the measurement channel.
1 ml to 2 ml of liquid can be necessary for subsequent tests on the
same channel. If a 3-way stopcock is used, as discussed in the “How
to Connect Infusion Devices” section, close the inlet of the Product
before you disconnect the infusion device to prevent leaks from the
channel.
14
Table 8 gives the function of each button in the Flow screen menu.
Infusion Device Analyzer
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Flow Tests
Table 8. Flow Screen Menu Controls
Channel 1 Flow
Average Flow 0.00
ml/h
Volume 0.00
Ml
Elapsed Time 00: 00: 00
Inst. Flow ml/h
Back Pressure mmHg
AutoStart Start End
Press ESC for Status Screen
Menu Control Description
AutoStart
Start
End Cancels the test.
Starts the test when liquid movement is sensed. This is the preferred procedure of
operation.
Starts the measurement immediately. This can find the start up qualities of an infusion
device.
After you select AutoStart or Start and then push ENTER, the channel flow
screen changes to its active mode as shown in Table 9.
Table 9. Channel Flow Measurement Parameters
Channel 1 Flow
ir09.eps
Average Flow 59.70
Volume 19.60
ml/h
ml
Elapsed Time 00: 20: 00
Inst. Flow 60.20 ml/h
Back Pressure 7 mmHg
Graph End
Press ESC for Status Screen
Measurement Description
Average Flow Calculated flow from the volume delivered since the test started and the current time.
Volume Volume delivered since the test started.
Elapsed Time The time since the test started.
Inst. Flow
Back Pressure
Calculated flow rate for the last measurement interval, or at slower flow rates the last
60 μl.
Pressure at the inlet of the Product which is the pressure the infusion device pushes
against.
ir10.eps
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Select Graph on the menu and then push ENTER to show a graph of the test
progress as shown in Figure 6 prime mode. Push End and then ENTER to
complete the test and go to the Flow screen (End Mode).
Channel 1 Flow Graph (Ave)
80
Ml/h
0
0 Min 30
Press ESC for Status Screen
Figure 6. Channel Flow Graph
Average
59.70
Deviation
-0.50%
Inst
60.20
Total Volume
19.60
Elapsed Time
00:20:00
+ -
View Detail
Ave/Inst
gir11.eps
In addition to the graph, the same parameters in the flow screen are shown along
the right side of the graph screen. An additional parameter shows the deviation
percentage from the set flow rate.
Table 10 shows the controls in the lower-left corner of the Channel Flow Graph
screen and describes their purpose.
Table 10. Flow Graph Screen Controls
Control Description
Shows the default zoom level.
Shows the default zoom view. This icon replaces the magnifying glass when the graph is
zoomed.
Zoom in (expand) the Y-axis.
Zoom out (contract) the Y-axis.
View Detail Go to the Channel Flow screen (see Table 11).
Ave/Inst
Changes the graph that is shown. Each push cycles through the views of Average,
Instantaneous, and Average and Instantaneous.
When the test is completed, the menu at the bottom of the screen changes to the
menu shown in Table 11.
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Infusion Device Analyzer
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Flow Tests
Table 11. Flow Screen in End Mode
Channel 1 Flow
Average Flow 59.70
Volume 20.00
ml/h
ml
Elapsed Time 00:20:00
Inst. Flow 0.00 ml/h
Back Pressure 0 mmHg
Save Save & Print Print
Graph Delete
Press ESC for Status Screen
Menu Control Description
Save Keeps the results of the test after prompt for test data and comments.
Save & Print Keeps the results and prints the results.
Print Prints the test results. Does not save the results.
Graph Shows a graph of the test.
Delete Erases the results after confirmation.
Caution
To avoid inaccurate readings, always repeat a test when
“Bubble” or “Air Lock” is shown on the display while a test is
running. See the “Troubleshooting” section of this manual.
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Occlusion Tests
When Occl is selected from the Device Information screen, the Occlusion Start
Mode screen in Table 12 is shown. Table 13 tells you about each field.
When the Occlusion Start Mode screen is first shown, Start briefly shows Wait
as the pressure circuit is zeroed.
Table 12. Occlusion Screen in Start Mode
Channel 1 Occlusion
Pressure 0.00
Elapsed Time 00:00:00
Peak Pressure 0.00 psi
Time of Peak 00:00:00
Start End
Press ESC for Status Screen
Menu Control Description
psi
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Start Starts the measurement.
End Stops the measurement.
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Infusion Device Analyzer
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Occlusion Tests
When you select Start, the Channel Occlusion screen in Table 13 shows
measurement data as the test continues. Select Graph to show the test data as
a graph.
Table 13. Occlusion Screen in Active Mode
Channel 1 Occlusion
psi
Pressure 7.50
Elapsed Time 00:09:10
Peak Pressure 8.04 psi
Time of Peak 00:08:23
Graph End
Press ESC for Status Screen
Measurement Description
ir14.eps
Pressure Shows the amount of pressure and is set by the Operator or the User Defaults.
Elapsed Time Time since the test was started.
Peak Pressure Highest pressure sensed since the test started.
Time of Peak The time that highest pressure was sensed.
The Occlusion Graph screen for the same test is shown in Figure 7. The same
numerical data is shown.
Channel 1 Occlusion Graph
10
psi
0
0 Min 30
Press ESC for Status Screen
Figure 7. Occlusion Graph Screen
Inst psi
7.50
Peak psi
8.04
Elapsed Time
00:09:10
Peak
00:07:23
View Detail
gir15.eps
Select View Detail to see the Occlusion Detail screen shown in Table 14.
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Table 14. Occlusion Screen in End Mode
Channel 1 Occlusion
Peak Pressure 8.04
Time of Peak 00: 07: 23
Total Test Time 00: 09: 10
Set Flow Rate 5.00
Save Save & Print Print
Graph Delete
Press ESC for Status Screen
psi
ml/h
Menu Control Description
Save Keeps the results of the test after prompt for test data and comments.
Save & Print Keeps and prints the results.
Print Prints the results. Does not save the results.
ir16.eps
Graph Shows a graph of the test.
Delete Erases the results after confirmation. Does not save results.
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Infusion Device Analyzer
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How to Test PCA Pumps
How to Test PCA Pumps
When PCA is selected from the Device Information screen, the PCA/Dual Flow
Information screen in Table 15 is shown. Necessary PCA pump data can be
added from this screen. For test purposes, a dual flow pump can be considered
to be a PCA pump that delivers a single, large bolus.
Table 15. PCA/Dual Information Screen
Chan 1 PCA/Dual Information
Basal/SecondaryFi 5.00 ml/h
Flow(Continuous)
Total Volume 10.00 ml
Bolus/Primary Volume 1.00 ml
Lockout Time 10 min 00 sec
Loading Dose ml
Press ESC for Status Screen
Measurement Description
The low continuous flow rate supplied by the infusion device. When a flow rate is
Basal/Primary
Flow Rate
Total Volume
Bolus/Secondary
Volume
Lockout Time
Loading Dose
recorded on the Device Information screen, it is transferred to the Basal/Primary Flow
Rate field of the PCA Information screen. This must be less than 25 % of the expected
bolus/secondary flow rate for reliable detection.
The total volume expected from the infusion device. When total volume is recorded on
the Device Information screen, it is transferred to Total Volume field of the PCA
Information screen.
The volume of bolus to be delivered when the patient-demand button on the infusion
pump is pushed. When a Dual Flow pump is tested, this is the secondary volume.
Recorded for the report only.
The volume of the initial dose (available on some pumps).
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Users Manual
When ENTER is pushed in the Loading Dose field, the PCA screen changes to
the Prime Mode screen shown in Figure 8. Refer to the Flow Tests section and
prime the channel.
Figure 8. PCA Screen - Prime Mode
gir18.bmp
When the channel is primed, the Prime button is replaced by the AutoStart and
Start buttons. If the basal flow rate is 0.00, select Start to begin the test. Select
Autostart if the basal flow rate is not 0.00.
When the test is in operation, the product monitors basal flow rate, number of
boluses delivered, bolus flow rates, volumes, and durations as shown in
Table 16. Bolus intervals are also monitored. Figure 9 shows a graph of the
supplied boluses and average parameters for all boluses. When a dual flow
pump is tested, it is shown as a single, large bolus followed by the secondary
flow.
Table 16. PCA Screen in Active Mode
Menu Control Description
Graph Shows a graph of the test. See Figure 9.
Trig
End Stops the test.
Adds a marker to the saved data when pushed. Push ENTER at the same time as
patient demand on the pump.
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Infusion Device Analyzer
Dual Flow Pump Test
Channel 1 PCA/Dual Flow Graph
80 Ave
ml/h
3
0
65.00
Total Vol
6.00
15 min
VIEW DETAIL
Press ESC for Status Screen
Figure 9. PCA Graph Screen
Bolus Count
Basal Avg
Bolus Avg
ml:
gir20.eps
Caution
To avoid inaccurate readings, always repeat a test when
“Bubble” or “Air Lock” is shown on the display while a test is
running. See the “Troubleshooting” section of this manual.
Dual Flow Pump Test
During a test, a dual flow pump can be thought of as a PCA pump that supplies a
large, single bolus.
The primary flow rate must be recorded in the basal flow rate field of the PCA
Information screen. Record the secondary volume in the bolus volume field.
Templates
The Product helps automate and standardize the testing of infusion devices.
Templates are used by the Product to control the sequence of tests done on an
applicable type of infusion device.
Before you can do this, a template for the type of infusion device you will test
must be defined. It is necessary to define a template only once for a particular
type of infusion device. Refer to the device’s manufacturer or service
documentation for necessary test parameters.
The subsequent section shows an example of a generic syringe pump that
requires you test at a flow rate of 20 ml/h for a volume of 10 ml over 30 minutes,
and 50 ml/h for 10 ml, both with a tolerance of 5 %. The occlusion must be tested
at 50 ml/h with an alarm pressure of 12 psi.
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Define a Template
To define a template:
1. From the Status All Channels screen, select ESC for Utilities.
2. Select Edit Templates.
3. On the Templates screen, select Add. The Template Detail screen is shown
in Table 17.
4. Record the values shown in Table 17.
Table 17. Template Detail Screen
Template Detail
Name SYRINGE DEMO TEMPLATE
Comment Syringe pump quick check
Step Type
1 FLOW 20 10 ml 00:30 5
2 FLOW 50 10 ml 5
3 OCCL 50 12 psi 00:05 0
4
5
6
Flow
Rate
Vol Pres
Save Delete Step
Press ESC for Templates screen
Field Description
Unit
hh:mm
Delete Template
Time
Tol%
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Name Record a name for your template.
Comment More data can be recorded here.
Use the down arrow to set the Type of test from the list (“FLOW” in this case).
Step 1 Type
Note
The Unit field is ml. ml is the only applicable unit for a flow
step.
Rate Record the flow rate (20 for this example).
Vol/Press Record the volume/pressure which will be used for the test (10 for this example).
Unit Push ENTER to accept ml.
Time Record the maximum time for the test (00:30 for this example).
Initially, this field holds the default value from the Test Preferences screen.
Tol%
Note
The tolerance value is ignored for occlusion tests.
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Infusion Device Analyzer
Templates
5. Repeat for steps 2 and 3. Use the values shown in Table 17.
6. At step 4, keep the Type field empty and push ENTER. Save is highlighted.
7. Push ENTER. The Templates screen is shown with your template added to
the list.
8. Select ESC to access the Utilities menu.
9. Select ESC again to access the Status All Channels screen.
Template Operation
To use a Template:
1. From the Status All Channels screen, push SETUP for the channel to be
used.
2. Select Template.
3. Push the up and down arrow keys to select the correct template.
4. Push ENTER. Start is highlighted.
5. Push ENTER. The Device Information screen in Table 5 shows with values
from Step 1 of the template.
6. Record a control number and operator. The values from the template are
skipped.
7. Select More if it is necessary to record more data about the infusion device or
select the test type defined in the template.
8. The test operates until the set volume or time is reached. It automatically
goes to the Flow Terminated screen with a message “Set Volume Reached”
or “Set Time Reached” as applicable. A new menu button, Next Template
Step, is shown and highlighted.
9. Push ENTER on the Next Template Step button and you are prompted to
set the infusion device for the subsequent step of the template.
10. Do each template step as prompted. After the last step, Save is highlighted
on the Test Terminated screen.
11. Select the Save button.
12. Push ENTER. You are prompted for comments.
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Utilities
To open the Utilities menu screen shown in Figure 10, select ESC from the
Status All Channels screen. The subsequent sections tell you more about the
menu items.
Utilities
Recall Tests Instructions
Set Clock Report Header
User Preferences Test Preferences
Printer Setup/Test Calibration
Cancel Print Edit Templates
Press ESC for Status Screen
Figure 10. Utilities Menu Screen
gir22.eps
Recall Tests
With Recall Tests, you can see, print, or delete the results of saved tests. The
default view, shown in Table 18, has the most recent test at the top of the list. To
re-order test results, highlight a column header and reorganize them into
ascending or descending sequence.
Table 18. Recall Tests Screen
Recall Tests
Control Number Test Type Date
1234567 Flow Ch 2 4-May-2010 12:02 □▲
2345678 Flow Ch 1 4-May-2010 11:58 □ █
□ █
□ █
□ █
□ █
□ █
□ █
□ █
□ █
□ █
□ █
□▼
View Graph Print Summary Print Full Delete Select All
ESC=Utilities; Enter (Un)Select; ▼▲Move; ◄► Options
Menu Control Description
View Graph
Available when a single test is selected. See the graph of a test and scroll through the
data.
ir23.eps
Print Summary Prints a single-page summarized report for each selected test.
Print Full Prints a complete report, with all data points, for each selected test.
Delete Erases all highlighted tests.
Select All Select or de-select all tests.
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Infusion Device Analyzer
Utilities
At the bottom of the screen, there are context-sensitive prompts. Use the up and
down arrows to highlight or un-highlight a test, then use the left or right arrows to
move to the Options menu.
Set Clock
Use Set Clock to set the time for your time zone. The time is recorded for the
start of each test.
User Preferences
With User Preferences, you can adjust the volume of the alert (beep) and the
brightness of the screen.
Printer Setup/Test
Use Printer/Setup to make your report compatible with your printer.
Cancel Print
Cancel Print stops a report that is currently being printed.
Instructions
Instructions shows brief operating instructions. Follow the prompts at the bottom
of this screen. There is also a note application available from this screen.
Report Header
Record a maximum of three lines of text to show at the top of your reports. Each
line can be a maximum of 28 characters. It is suggested that the first line be your
establishment name.
Default Test Preferences
From the Default Test Preferences screen shown in Figure 11, you can specify
the default behavior of the Product when tests are in progress.
Default Test Preferences
Test Stop Preferences
When Volume ▼ Reached then No Action ▼
Pressure Units psi ▼ Flow Tolerance 5 %
Use the left and right arrow keys to select.
Use the up and down arrow keys to change
Press ESC for Utilities and cancel the changes
Figure 11. Default Test Preferences Screen
Preferred Parameters
Press ENTER to Accept
.
gir24.eps
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The Product can automatically do tests in a specific manner when specified
conditions are met. Test-stop preferences specifies the default actions that are to
occur. Default values can be changed at the start of each test.
Set which step to edit from the drop-down list in the When field:
• Volume When the set volume is reached. Zero disables
this.
• Time When the set time is reached. 00:00 disables this.
• First Condition Whichever of volume or time is first reached.
• Both Conditions When both the time and volume are reached.
The action when the condition is met is selected from the drop-down list
presented by the Reached then field:
• No Action The test continues. The user is not told.
• Notify Operator A beep sounds and a message shows.
• Stop Test Only The test stops, a beep sounds, and a message
shows.
• Stop Test & Save The test stops and is saved. A message tells you
the test is saved.
The Preferred Parameters let you choose default pressure units and the
position of tolerance lines on flow graphs. Psi, kPa, and mmHg pressure units
are available. The percentage tolerance can be from 0 % to 50 %.
Calibration
The Calibration menu gives access to calibration history and factory functions.
Some items on this menu are available to authorized-service personnel only.
Each screen has instructions on usage. “View Optics” is a diagnostic utility.
Edit Templates
See the “Templates” section earlier in this manual.
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Infusion Device Analyzer
Troubleshooting
Troubleshooting
Tables 19 and 20 show you Bubble and Air Lock errors and their solutions.
Possible Cause Solution
Make sure to remove all air when you connect the
Table 19. Bubble Errors
Air caught in the delivery tube
infusion device to the analyzer. Use care with the
connections.
Incorrect priming
Degassing of the test fluid
Use the method given in this manual to prime the
product.
For longer flow tests, let the test fluid become
stable to room temperature before use.
Table 20. Air Lock Errors
Possible Cause Solution
Use the method given in this manual. Use a syringe
Incorrect arrangement of drain tubes
of air to gently push all excess water out of the
measuring channel.
Blockage of the drains (such as trapped or
Examine and unblock as necessary.
kinked tubes)
Contamination of the fluid measure circuit
Use the cleaning instructions found in the “Product
Maintenance” section of this manual.
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Product Maintenance
The subsequent sections tell you how to maintain the Product.
Clean the Product
Warning
To prevent possible electrical shock, fire, or personal injury:
• Turn the Product off and remove the mains power cord.
Stop for two minutes to let the power assemblies discharge
before you open the fuse door.
• Do not operate the Product with covers removed or the case
open. Hazardous voltage exposure is possible.
• Disconnect the mains power cord before you remove the
Product covers.
• Remove the input signals before you clean the Product.
• Use only specified replacement parts.
Outside
Inside
• Use only specified replacement fuses.
• Have an approved technician repair the Product.
• Do not pour fluid onto the Product surface; fluid seepage
into the electrical circuitry may cause the Product to fail.
• Do not use spray cleaners on the Product; such action may
force cleaning fluid into the Product and damage electronic
components.
Caution
To prevent possible damage to the Product or to equipment
under test, remove the input signals before you clean the
Product.
After troubleshooting or maintenance, restart the Product and ensure it starts
without errors. (See Product Operation.)
To clean the outside of the Product, disconnect from the power supply and use
only a damp cloth with mild detergent.
It is possible that microbial growth can become present in the transducers of the
Product. It is recommended that you clean the transducers at 3 month intervals.
To clean the inside of the Product, inject 20 ml of a warm water and detergent
solution into the Fluid Inlet Port. After 5 minutes, flush with clean water. Always
pass water from the fluid inlets to the outlets.
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Infusion Device Analyzer
Product Maintenance
Replaceable Parts
Table 21 lists the replaceable parts for the Product.
Table 21. Replaceable Parts
Item Fluke Biomedical Part Number
Plastic syringe (20 ml) 4354014
3-way Luerlock 4354038
Miniature keyboard 4354490
Ansur test software, IDA-5 Plug-In License 4354503
One channel upgrade option 4354532
HydroGraph software and IDA-5 Users Manual on CD 3976006
Drain tube 1.5 m (5 ft) 4354429
USB A-B Cable 4354452
Micro-90 (225 ml) 4541948
IDA-5 Getting Started 3975990
Australia 658641
North America 284174
Denmark 2200218
Europe 769422
Power cord
Italy 2198785
India, South Africa 782771
Swiss 769448
United Kingdom 769455
Brazil 3841347
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Test Fluid
The Product is intended to operate with de-ionized water with added detergent.
Fluids intended for use on patients, such as high viscosity, oily, or corrosive
substances will damage the measurement system. Tap water can contain
contaminates which can also damage the transducer.
Test fluid can be made with de-ionized water and a wetting agent such as
MICRO-90. It is recommended that a 0.1 % solution of MICRO-90 in de-ionized
water (preferably degassed) be prepared in volume for daily use and kept in a
sealed vessel. If the water makes too much foam, then a 0.05 % dilution is
recommended.
MICRO-90 is available from:
International Product Corp.
201 Connecticut Dr.
P.O. Box 70
Burlington, NJ 08016-0070 USA
Tel 609 386 8770
International Product Corp.
1 Church Row
Chistlehurst, Kent BR7 5PG United Kingdom
Tel. 0208 467 8944
Storage
Remove all water from the Product before storage, particularly if temperatures
can fall below 5 °C (41 °F). Do not pressurize the inlet ports. It is safest to use a
medical suction pump to drain the measuring channels and use the Cycle Valves
from the Calibration menu (follow on-screen instructions).
Shipping
Remove all liquid from the Product before shipping. To prevent liquid from
entering the ports, put the Product in a large plastic bag. Put the bagged Product
into its shipping carton. If this is not available, make sure there is shock
protection with a minimum of 5 cm compressible cushioning inside the carton (for
example, 60 cm x 60 cm x 60 cm).
32
Infusion Device Analyzer
General Specifications
General Specifications
Operating Voltage Range ..................................... 100 V ac to 240 V ac
Supply Frequency ................................................. 50/60 Hz
Supply Power ........................................................ <50 VA
Fuses ...................................................................... 20 mm T1.6 A H 250 V x 2
Size (H x W x D) ..................................................... 30 cm x 20 cm x 20 cm (12 in x 8 in x 8 in)
Weight .................................................................... ~5 kg (11 lb)
Altitude ................................................................... 0 m to 3000 m (10000 ft)
Temperature
Operating ............................................................ 15 °C to 30 °C (59 °F to 86 °F)
Storage ............................................................... -20 °C to +40 °C (-4 °F to +104 °F) when drained of all liquid
Humidity ................................................................. 10 % to 90 % non-condensing
Templates .............................................................. Predetermined Test Sequences. Typical capacity 200
Safety ..................................................................... IEC 61010-1: Overvoltage category II, Pollution Degree 2
Electromagnetic Environment ............................. IEC 61326-1: Portable
Emissions Classification...................................... IEC CISPR 1: Group 1, Class A. (Group 1 have intentionally generated
FCC ......................................................................... CFR47 Part 15.107 and 15.109 Class A
Storage of Results ................................................ Test results stored for later viewing, printing or transfer to PC. Typical
Power down ........................................................... The results of tests in progress will be saved in accidental power down
Computer Control ................................................. The Product can be fully controlled using PC HydroGraph and Ansur
and/or use conductively coupled radio-frequency energy which is
necessary for the internal functioning of the equipment itself. Class A
equipment is suitable for use in non-domestic locations and/or directly
connected to a low-voltage power supply network.)
capacity: 250 tests.
software for the Product
Performance Specifications
Flow Rate Measurement
Method ................................................................ Flow is calculated by measuring volume over time
Range ................................................................. 0.1 ml/h to 1500 ml/h (2500 ml/h is shown)
Accuracy ............................................................. 1 % of reading ±1 LSD for flows of 16 ml/h to 200 ml/h for volumes
Max Test Duration .............................................. 100 hours
Volume Measurement
Method ................................................................ Volume is measured directly by the measuring module in minimum
Range ................................................................. 0.06 ml to 9999 ml
Accuracy ............................................................. 1 % of reading ±1 LSD for flow rates of 16 to 200 ml/h for volumes over
Max Test Duration .............................................. 100 hours
PCA Bolus/Dual Flow Measurement
Method ................................................................ See Volume measurement above
Min Bolus Volume ............................................... 0.5 ml
Resolution ........................................................... 60 μl increments
Max Test Duration .............................................. 100 hours
Pressure Measurement
Method (back Pressure and Flow test) ............... Direct measurement of pressure at the inlet port.
Range ................................................................. 0 psi to 45 psi or equivalent in mmHg and kPa
Accuracy ............................................................. 1 % of Full Scale ±1 LSD under laboratory conditions
Max Test Duration .............................................. 1 hour
over 20 ml, otherwise 2 % of reading ±1 LSD for volumes over 10 ml
under laboratory conditions. Degassed water at 15 °C to 30 °C (59 °F
to 86 °F) is recommended for long tests.
sample sizes of 60 μl
20 ml. otherwise 2 % of reading ±1 LSD for volumes over 10 ml under
laboratory conditions.
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