2005 Fluke Corporation. All rights reserved. Printed in USA
All product names are trademarks of their respective companies.
IDA-4 Plus
Operators Manual
ii
Infusion Pump Analyzer Contents
Contents
Contents................................................................................................................................................................ iii
Notices................................................................................................................................................................. vii
Customer Service and Sales ................................................................................................................................ vii
All Rights Reserved............................................................................................................................................. vii
Restrictions and Liabilities .................................................................................................................................. vii
Claims.................................................................................................................................................................. vii
Warnings ............................................................................................................................................................ viii
Patient Circuit..................................................................................................................................................... viii
Contamination of the Measuring System ........................................................................................................... viii
Explosion Risk ................................................................................................................................................... viii
Switching the Instrument ON or OFF ................................................................................................................ viii
Connections........................................................................................................................................................ viii
Storage and Shipping............................................................................................................................................ ix
Removing Internal Water before Shipping or Storage ......................................................................................... ix
Storage and Packing ............................................................................................................................................. ix
Trademarks........................................................................................................................................................... ix
Manufacturing Location ....................................................................................................................................... ix
Warranty................................................................................................................................................................ x
Warranty and Product Support ...............................................................................................................................x
About This Manual............................................................................................................................................. 1-1
Features .............................................................................................................................................................. 1-2
An Overview .......................................................................................................................................... 2-1
Description of the Device and Intended Use ...................................................................................................... 2-1
General ............................................................................................................................................................... 2-1
Model Variations................................................................................................................................................ 2-1
Occlusion & Back Pressure Measurement ......................................................................................................... 2-1
Front Panel Description...................................................................................................................................... 2-2
Front Panel Layout Drawing .............................................................................................................................. 2-3
General Operating Notes .................................................................................................................................... 3-4
First Time Use.................................................................................................................................................... 3-4
Set Clock ............................................................................................................................................................ 3-4
Test Parameters ..................................................................................................................................................3-4
Test Fluid............................................................................................................................................................ 3-4
Warning of Contamination ................................................................................................................................. 3-5
Status All Channels Screen ................................................................................................................................ 3-6
Set Clock ............................................................................................................................................................ 3-7
RS232 Port ......................................................................................................................................................... 3-9
Test Parameters ................................................................................................................................................ 3-10
Sub Menu1 ....................................................................................................................................................... 3-13
Sub Menu2 ....................................................................................................................................................... 3-14
Flow Test Screen (Prime Mode)....................................................................................................................... 3-15
Flow Test Screen (Start Mode)......................................................................................................................... 3-15
Flow Test Screen (Measuring Mode) ............................................................................................................... 3-16
Flow Test Screen (End of Test Mode).............................................................................................................. 3-17
Occlusion Test Screen ...................................................................................................................................... 3-19
Occlusion Test Screen (Wait Mode)................................................................................................................. 3-19
Occlusion Test Screen (Start Mode)................................................................................................................. 3-20
Occlusion Test Screen (Measuring Mode......................................................................................................... 3-20
Occlusion Test Screen (End of Test Mode)...................................................................................................... 3-21
PCA Test Information Screen........................................................................................................................... 3-23
PCA Test Screen .............................................................................................................................................. 3-24
PCA Test Screen (Prime Mode)....................................................................................................................... 3-24
PCA Test Screen (Start Mode)......................................................................................................................... 3-25
PCA Test Screen (Measuring Mode)................................................................................................................ 3-25
PCA Test Screen (End of Test Mode).............................................................................................................. 3-26
Dual Rate Test Information Screen .................................................................................................................. 3-30
Dual Rate Test Screen ...................................................................................................................................... 3-31
Dual Rate Test Screen (Prime Mode)............................................................................................................... 3-31
Dual Rate Test Screen (Start Mode)................................................................................................................. 3-31
Dual Rate Test Screen (Measuring Mode) ....................................................................................................... 3-32
Dual Rate Test Screen (End of Test Mode)...................................................................................................... 3-33
Measuring Flow-rate against Back-pressure .................................................................................................... 3-35
iv
Infusion Pump Analyzer Contents
Suggested Apparatus for Back Pressure Testing Drawing ............................................................................... 3-36
4 Maintenance, Service and Calibration
User Care and Maintenance................................................................................................................................ 4-1
Care of the Instrument Case ............................................................................................................................... 4-1
Cleaning the Inside of the Instrument................................................................................................................. 4-1
User Performance Check.................................................................................................................................... 4-2
A Infusion Devices Delivery Methods
Infusion Devices: An Overview ........................................................................................................................ A-1
Pumps for Ambulatory Use............................................................................................................................... A-2
Other Devices.................................................................................................................................................... A-2
General .............................................................................................................................................................. A-2
General .............................................................................................................................................................. A-4
Pumps for Ambulatory Use............................................................................................................................... A-6
Perform a Flow Test [CnF,a,b,c] ........................................................................................................................B-2
Perform a Volume Test [CnV,a,b,c]...................................................................................................................B-3
Perform an Occlusion Pressure Test [CnO, a,b,c] ..............................................................................................B-3
Perform a PCA Test [CnPCA,a,b,c]...................................................................................................................B-3
Perform a Dual Flow Rate Test [CnD,a,b,c,d,e,f] ..............................................................................................B-4
Fetch the Current Flow Measured on a Channel [FLOWn] ...............................................................................B-4
Fetch the Current Volume Accumulated on a Channel [VOLn] ........................................................................B-4
Fetch the Current Pressure on a Channel [PRESn].............................................................................................B-5
Fetch the Peak Pressure on a Channel [PKPRESn]............................................................................................B-5
v
IDA-4 Plus
Operators Manual
vi
Infusion Pump Analyzer Notices
Notices
Fluke Biomedical
6920 Seaway Blvd.
Everett, WA 98203
USA
Customer Support and Sales
USA and Canada: 800.648.7952
Outside the USA: 775.883.3400
Sales E-Mail: sales@flukebiomedical.com
Internet: www.flukebiomedical.com
Service:
USA and Canada: 888.993.5853
Outside the USA: 425.446.5560
For additional sales or service information, contact your local Fluke Biomedical
Distributor or Fluke Electronics office
All Rights Reserved
Copyright 2005, 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.
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 its affiliated dealers.
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.
Obtaining Assistance
If you have trouble operating the IDA-4 Plus, or just need some clarification on its
operation, contact Fluke Biomedical’s Technical Assistance Center at 800-648-7952.
Returning the Instrument to Fluke
If it becomes necessary to return your instrument to Fluke, proceed as follows:
1. Every product returned to Fluke must have a Return Material Authorization
(RMA) number. To obtain an RMA, contact Fluke through one of the
following methods:
Phone: 888-99FLUKE (888-993-5853) or 425-446-5560
Email: service@fluke.com
vii
IDA-4 Plus
Operators Manual
Warnings
2. Pack the instrument carefully, using the original packing materials if available.
Failure to pack the instrument properly could void your warranty and result in
you paying for the instrument’s repair.
3. Insure the unit for full retail value and ship to the address specified by Fluke
Patient Circuit
This instrument has been designed for testing infusion devices but must NEVER be
used while connected to a patient.
Tubing sets utilized to test infusion devices must never be used to administer fluids to
patients.
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 care
must be taken to avoid possible contamination of reusable components due to
backflow conditions.
Contamination of the Measuring System
For best results use degassed water made up with detergent, as described under ‘Test
Fluid’ on page 3-4.
High viscosity fluids cannot be used. Liquid containing oils (solvents, or strong
chemicals) may also damage or contaminate the transducer. Do not use "Bleach" type
of sterilizing agents, or alcohol’s.
To extend the life of the transducer and to maintain accuracy it is recommended that
periodically 20 ml of detergent solution be introduced into the fluid inlet port, left for
30 minutes, and then flushed out with 500 ml of clean water.
Care should be taken to prevent dirt, dust, metal swarf, or other debris from entering
the measuring system since these are likely to damage the transducers.
Explosion Risk
This instrument is not to be used in the presence of flammable anesthetic gases or
vapors.
Switching the Instrument ON
As is common with most other computing equipment, this instrument may be
damaged by repeated interruption of the power supply, either by rapid switching ON
or OFF, or by removing the line cord when the instrument is energized. After
switching OFF allow at least 3 seconds before switching the unit ON. Never
disconnect the line cord without first switching the unit OFF.
or OFF
The ON / OFF switch is located on the rear panel of the unit.
Connections
All external leads connecting to the IDA-4 Plus e.g. RS232 and Printer leads, must be
no longer than 2.5 meters in length.
viii
Infusion Pump Analyzer Storage and Shipping
Storage and Shipping
Removing Internal Water before Shipping or Storage
Before long-term storage or shipping it is recommended that all-internal water be
removed from the instrument. After manufacture and testing, internal water is
removed by connecting the FLUID OUT ports to a (medical) suction pump for 2
minutes in the unit “OFF” condition. Users may wish to employ this method, which
will not harm the unit.
Do not use compressed air to clear out internal water since pressures greater than 310
kPa (45 psi) may damage the pressure transducer.
Storage and Packing
Remove as much internal water as possible (as described above).
Store away from sunlight.
Protect from frost (internal water may freeze and expand)
Protect from vibration and shock
The unit is a delicate electronic measuring instrument and as such should be cared for
in the appropriate manner.
The unit should not be opened unless there is a facility to confirm the function and
calibration of the unit afterwards.
There are certain types of keyboard that under ESD conditions can cease to function.
Disconnecting the keyboard and reconnecting usually restores normal keyboard
function. It is recommended a CE marked keyboard is used.
Trademarks
All trademarks mentioned in this document are acknowledged.
Manufacturing for:
Fluke Biomedical
6920 Seaway Blvd
Everett, WA 98203 USA
775-883-3400
800-648-7952
ix
IDA-4 Plus
Operators Manual
Warranty
Warranty and Product Support
Fluke Biomedical warrants this instrument against defects in materials and
workmanship for one full year from the date of original purchase. 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 does not apply if the product has been damaged by accident or misuse
or as the result of service or modification by other than Fluke Biomedical. IN NO
EVENT SHALL FLUKE BIOMEDICAL BE LIABLE FOR CONSEQUENTIAL
DAMAGES.
Only serialized products and their accessory items (those products and items bearing
a distinct serial number tag) are covered under this one–year warranty. PHYSICAL
DAMAGE CAUSED BY MISUSE OR PHYSICAL ABUSE IS NOT COVERED
UNDER THE WARRANTY. Items such as cables and nonserialized modules are
not covered under this warranty.
Recalibration of instruments is not covered under the warranty.
This warranty gives you specific legal rights, and you may also have other rights
which vary from state to state, province to province, or country to country. This
warranty is limited to repairing the instrument to Fluke Biomedical’s specifications.
Warranty Disclaimer
Should you elect to have your instrument serviced and/or calibrated by someone other
than Fluke Biomedical, please be advised that the original warranty covering your
product becomes void when the tamper-resistant Quality Seal is removed or broken
without proper factory authorization. We strongly recommend, therefore, that you
send your instrument to Fluke Biomedical for factory service and calibration,
especially during the original warranty period.
In all cases, breaking the tamper-resistant Quality Seal should be avoided at all cost,
as this seal is the key to your original instrument warranty. In the event that the seal
must be broken to gain internal access to the instrument, you must first contact Fluke
Biomedical’s Technical Assistance Department at 775-883-3400. You will be
required to provide the serial number for your instrument as well as a valid reason for
breaking the Quality Seal. You should break this seal only after you have received
factory authorization. Do not break the Quality Seal before you have contacted us.
Following these steps will help ensure that you will retain the original warranty on
your instrument without interruption.
x
Chapter 1
Introduction
This chapter introduces the
instrument and describes its features.
Thank you
Thank you for purchasing this instrument. It will allow you to verify the operation of your
infusion devices providing measurements of volume delivered, flow rate and occlusion and
backpressure.
Introduction
There is now a reliable way to verify the condition and performance of infusion devices
with various methods of delivery. This instrument has been provided to the medical and
health industry so that the performance of most infusion devices currently on the market
can be determined.
Device Compatibility
The purpose of this unit is to quickly establish the state of any given infusion device and to
determine the performance qualities of the device. This instrument can test and evaluate
virtually any infusion device on the market today.
Because each infusion device manufacturer uses slightly different technology and delivery
methods vary, provisions have been made to measure all currently used methods of
delivery.
About This Manual
The intent of this user's guide is to quickly instruct the new user on how to set up and
operate this instrument. To this end, we've employed certain conventions to help you read
and understand this manual.
The operation of this instrument is shown with LCD screen detail and text instructions and
description, including which particular button to press, alongside the screen.
1-1
IDA-4 Plus
Operators Manual
Features
9 Tests up to four Infusion Devices simultaneously (when four measuring Transducers fitted)
9 Five button keypad operation
9 Measurement of Volume Delivered
9 Measurement of Flow Rate
9 Measurement of Occlusion Pressure
9 Measurement of Back Pressure
9 Menu driven Utilities settings
9 LCD (liquid crystal display) super twist Graphics with back light
Package Contents
The contents of this package as shipped include:
9 The main unit
9 Line Cord
9 4 x 3 way Luer stopcock.
9 1 x 20 ml syringe
9 4 x Drain tubing
9 2 x Fuse
9 Operator’s Manual
9 Calibration Certificate
9 Certificate of Conformity
9 Registration card
1-2
Infusion Pump Analyzer
Introduction
Specifications
Electrical Specification:
Supply Voltage 90 - 260 VAC.
Supply Frequency 50 - 60 Hz.
Supply Power < 30 VA.
Fuse 20 mm 250 V, 1 A (T) (slow blow).
Earth Leakage Current < 1.0 mA in single fault condition.
Flow Rate Measurement
Technique: Flow is calculated by measuring a volume over time.
Range: 0.5 - 1000 ml/hr.
Accuracy: 1% of reading ± 1 LSD for flows of 16 - 200 ml/hr for volumes over 20 ml.
Otherwise, 2% of reading ± 1LSD after delivery of 10 ml under laboratory
conditions.
Volume Measurement
Technique: Volume is measured directly by the transducer in minimum sample sizes of
60 micro-liters.
Range: 0.06 - 9999 ml.
1
Accuracy: 1% of reading ± 1 LSD for flows of 16 - 200 ml/hr for volumes over 20 ml.
Otherwise, 2% of reading ± 1LSD after delivery of 10 ml under laboratory
conditions.
PCA Bolus Measurement
Technique: Volume is measured directly by the transducer in minimum bolus volumes
of 0.5 ml. The measurement is made with a continuous rate between 0.0 and
30 ml/hr. The bolus flow rate should be at least four times the basal flow
rate for reliable detection of boluses.
Min Bolus: 0.5 ml.
Accuracy: See volume measurement.
Pressure Measurement
Technique: Direct occlusion of the infusion line and measurement of pressure prior to
the glass transducer.
Range: 0 to 45 PSI and equivalents in mmHg and kPa.
Accuracy: 1% of Full Scale ± 1 LSD under laboratory conditions.
1-3
IDA-4 Plus
Operators Manual
Physical
Dimensions: ~19.05 cm x 18.11 cm x 30.18 (L x W x H)
(for rear panel handle add 3.81cm)
Weight: 5.0 Kg (with 4 transducer fitted)
Case: Molded plastic front panel, metal rear housing.
Color: RAL 9002
Environmental
Operational: 15-30 C up to 50% Relative Humidity
Storage: 0-40 C at 85% RH or less
Do not leave for more than 48 hours at -20 C
Transportability
If possible use the packaging supplied by the manufacturer. If this is not possible then enclose the
instrument in a clear plastic bag, and place it in a cardboard box with plastic packing materials,
with at least 5 cm (2 inches) between the instrument and the exterior of the box to protect against
shock. Remove all water before packing.
1-4
Chapter 2
An Overview
This chapter gives an overview of the
instrument to help you understand the system.
Description of the Device and Intended Use
General
This is an instrument providing an automated system for measuring the Flow Rate, Volume
Delivered and Occlusion (Stall) Pressure of Infusion Devices with various methods of
delivery.
It is used to verify the performance of Infusion Devices and provides facilities for
displaying results on the instrument’s LCD, saving test results for subsequent printing and /
or downloading to a PC.
Model Variations
There is one basic design which has provisions for one, two, three or four independent
channels of measuring transducers within a common housing, providing options for testing
up to four Infusion Devices simultaneously with one instrument.
Operational Modes
The unit can be used in a stand alone mode displaying results on the LCD and can
subsequently print saved test results via a printer port and / or download saved test results
to a PC via an RS232 port.
The unit may also be linked to, controlled by and display results via a PC using an external
program, such as HydroGraph™ available from Fluke Biomedical.
Volume & Flow Measurement
Volume and flow measurements are achieved by using a calibrated burette and optosensors within each measurement transducer to accurately monitor the volume and time of
the meniscus passing up the burette. This data is processed to
Bolus and Total Volume Delivered and Timing measurements.
provide Average Flow Rates,
Occlusion & Back Pressure Measurement
A pressure transducer within each transducer performs pressure measurement. The output
of the pressure transducer is fed to a conditioning amplifier then processed and the results
displayed on the LCD and, if connected, on the PC screen. The user has the option to
display Occlusion Pressure in psi, mmHg or kPa whereas Back Pressure measurement is
set to default to mmHg only.
2-1
IDA-4 Plus
Operators Manual
Front Panel Description
1. Liquid Crystal Display-240 dot (W) x 128 (H). Graphic and Alphanumeric. With
backlight.
2. Up, Down, Right and Left key-pad switches
3. Enter keypad.
4. Power ‘ON’ Indicator
5. Channel 1 Fluid ‘IN’ connector.
6. Channel 2 Fluid ‘IN’ connector.
7. Channel 3 Fluid ‘IN’ connector.
8. Channel 4 Fluid ‘IN’ connector.
2-2
Infusion Pump Analyzer
An Overview
Front Panel Layout Drawing
1
2
3
4
inlets
channel 1channel 2
channel 3channel 4
2
5678
2-3
IDA-4 Plus
Operators Manual
Rear Panel Description
9. Mains ON / OFF switch.
10. Three pin IEC mains inlet connection.
11. Twin fuses integral with mains connector.
12. Alarm Control port. 15 way. (for optional trigger interface).
13. Parallel Printer Port. 25 way Female.
Configured in the same way as a PC Printer Port.
14. Bar Code Wand Port. 9 way Female.
Configured for HP Smart Wand (2400 Baud, n, 8, 1).
15. Computer RS232 Port. 9 way Female.
Configured in the same way as PC COM Port.
16. Channel 4 Fluid ‘OUT’ connector.
17. Channel 3 Fluid ‘OUT’ connector.
18. PC AT keyboard Port.
Configured for AT keyboards.
19. Channel 2 Fluid ‘OUT’ connector.
20. Channel 1 Fluid ‘OUT’ connector.
21. Carrying handle.
2-4
Infusion Pump Analyzer
An Overview
Rear Panel Layout Drawing
2
2-5
IDA-4 Plus
Operators Manual
2-6 3-1
Chapter 3
Operating Instructions
This chapter discusses and illustrates the method
of connecting units under test and the
various operational modes.
Connecting Infusion Pumps under Test
See Inlet Hose Connections and Outlet Hose Connections drawings.
The Inlet Hose Connection drawing on the next page shows a method of connecting the
inlets from units under test together with a priming syringe, both connected via a 3-way
tap.
This method is the only method that should be employed with this instrument.
The Outlet Hose Connection drawing on page 3 shows the drain hose connections from the
unit to an open drainage collection vessel. Please note that the drain Fluid Outlets should
each have an independent hose to the drainage vessel and should not be joined in any way.
Note: Infusion device measurement accuracy is also affected by the
compliance of the infusion device and delivery tubes. This is because
there is a momentary blockage of flow when the measurement
transducer is emptied. The back-pressure created by these events
could cause some of the flow to be diverted into the compliance of the
infusion device. For most infusion devices, the effect is trivial (less
than 0.5%), but with very soft connecting tubing and large air pockets
in the device or tubing, it could be significant. The tubing between the
infusion device and the IDA-4 Plus should therefore be fairly rigid
and all air should be removed before starting each flow test. At high
flow rates it may be desirable to increase the compliance of the inlet
tubing (longer or softer tube) if the back pressure interferes with the
occlusion sensing alarms in the infusion device.
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