Fluke IDA-5 User Manual

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 [e-mail] or call
1-800-850-4608 or 1-440-248-9300. In Europe, email [e-mail] or call [phone].

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: [phone] x2564
Email: [e-mail]

instrument.

In Europe, Middle East, and Africa:
Eindhoven Calibration Lab
Tel: [phone]
Email: [e-mail]

Everett Calibration Lab
Tel: 1-888-99 FLUKE (1-888-993-5853)
Email: [e-mail]

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: [phone]
Email: [e-mail]

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

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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.