PN 4426198
February 2014, Rev. 2, 10/14
© 2014 Fluke Corporation. All rights reserved. Specifications are subject to change without notice.
All product names are trademarks of their respective companies.
IDA-1S
Infusion Device Analyzer
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 1-440248-9300. 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 instrument.
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
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 Europe, Middle East, and Africa:
Eindhoven Calibration Lab
Tel: +31-40-2675300
Email: ServiceDesk@fluke.com
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 in-house 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-1S Infusion Device Analyzer is manufactured for 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 .......................................................................................................... 8
Product Maintenance ..................................................................................................... 8
Clean the Product (Outside) ...................................................................................... 9
Clean the Product (Inside) ......................................................................................... 9
Test Fluid ................................................................................................................... 10
Storage ...................................................................................................................... 10
Shipping .................................................................................................................... 10
i
IDA-1S
Getting Started Manual
General Specifications ................................................................................................... 11
Performance Specifications ........................................................................................... 12
ii
Introduction
The IDA-1S Infusion Device Analyzer (the Product) is a
portable, battery-operated instrument that verifies the
performance of medical infusion devices. The Product
measures the flow rate and volume delivered and the
pressure generated in occlusions or blockages of the fluid
line.
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
• Battery charger / power supply
• Accessory Set:
o plastic syringe (20 ml)
o 3-way Luer plastic stop-cock
o extension tube, short (20 cm)
o drain tube (1 m)
o Micro-90
• CD (contains Users Manual and HydroGraph
Software)
• USB Cable
(100 ml)
1
IDA-1S
Getting Started Manual
Safety Information
A Warning identifies conditions and procedures that are
dangerous to the user. A Caution identifies conditions and
procedures that can cause damage to the Product or the
equipment under test.
Warning
To prevent possible electrical shock, fire, or
personal injury:
• Read all safety information before you
use the Product.
• Use the Product only as specified, or the
protection supplied by the Product can
be compromised.
• Remove the batteries if the Product is
not used for an extended period of time,
or if stored in temperatures above 50 °C.
If the batteries are not removed, battery
leakage can damage the Product.
• The battery door must be closed and
locked before you operate the Product.
• Replace the batteries when the low
battery indicator shows to prevent
incorrect measurements.
• Carefully read all instructions.
• Do not touch voltages >30 V ac rms,
42 V ac peak, or 60 V dc.
• Do not use the Product around explosive
gas, vapor, or in damp or wet
environments.
• Examine the case before you use the
Product. Look for cracks or missing
plastic. Carefully look at the insulation
around the terminals.
• Use this Product indoors only.
• Use only the mains power cord and
connector approved for the voltage and
plug configuration in your country and
rated for the Product.
• Replace the mains power cord if the
insulation is damaged or if the insulation
shows signs of wear.
• Use only the external mains power
supply included with the Product.
• Remove all probes, test leads, and
accessories before the battery door is
opened.
2
Infusion Device Analyzer
Safety Information
• Disable the Product if it is damaged.
Remove the batteries to disable the
Product.
• Do not use the Product if it is damaged.
• Do not use the Product on infusion
devices that are attached to patients.
• Do not reuse test tubing or syringes for
patient infusion.
• 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.
Caution
To prevent possible damage to the product
or to equipment under test:
• Only use degassed de-ionized water with
the Product. Wetting agent may be
added.
• 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 (for example,
unshielded intentional RF sources).
These sources may interfere with proper
operation.
3
IDA-1S
Getting Started Manual
Symbols
Table 1 is a list of symbols used on the Product and in
this document.
Table 1. Symbols
Symbol Description
Risk of Danger. Important information. See
Manual.
Hazardous voltage. Risk of electric shock.
Power input
USB
Conforms to European Union directives
Conforms to relevant North American
Safety Standards.
Table 1 Symbols (cont.)
Symbol Description
Conforms to relevant Australian EMC
standards
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.
4
Infusion Device Analyzer
Instrument Familiarization
Instrument Familiarization
Figure 1 and Table 2 show the controls and indicators on
the front panel of the Product.
1
2
3
6
4
5
hqf01.eps
Figure 1. Front-Panel Controls and Indicators
Table 2. Front-Panel Controls and Indicators
Item Description
Integrated Carrying Handle
Touch Display (LCD)
Charging Indicator – Illuminates when the
battery is charging
Power On Indicator:
• Green – Operating on ac power using the
charger
• Orange – Operating on battery
• Red – Battery low
WAKE UP Button – Turns on the Product. If
the startup screen appears without errors, the
product is ready to use.
Test Active Indicator – Flashes green when a
test is active
Before you turn on the Product, make sure the Product
calibration is up-to-date, check for signs of wear, and
ensure the battery door is closed.
5
IDA-1S
Getting Started Manual
Figure 2 and Table 3 show the connections on the side
panel of the Product.
1
2
4
3
5
hqf02.eps
Figure 2. Side-Panel Connections
Table 3. Side-Panel Connections
Item Description
Power Input for Battery Charger /
Power Supply 9 V dc
USB Port – Computer connection
Fluid Outlet (drain)
Pressure Inlet – For occlusion tests
Fluid Inlet – For flow tests
6
Infusion Device Analyzer
Product Connections
Product Connections
Warning
To prevent possible electrical shock, fire, or
personal injury:
• Only assemble and operate highpressure systems if you know the
correct safety procedures. High-pressure
liquids and gases are hazardous and the
energy from them can be released
without warning.
• Do not put metal objects into
connectors.
Caution
To avoid inaccurate readings, always repeat
a test when “Bubble” or “Air Lock” is shown
on the display while a test is running.
The Product connects to an infusion device through the
inlet ports on the side panel. The side panel also has the
connections for drain hoses and accessories.
Connect Infusion Devices
Figure 3 shows the Product connected for a flow test with
a 20 ml syringe attached to one 3-way stopcock inlet. Use
a syringe to prime the line before a test. Fluke Biomedical
recommends that you make all infusion device
connections to the Product through 3-way stopcocks.
Figure 3. Infusion Device Connections to the Product
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 the inlet between tests.
hqf03.eps
7
IDA-1S
Getting Started Manual
• 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.
Caution
To prevent possible damage to the product
or to equipment under test , do not use
delivery set or components that have been
used for prior testing for patient infusion.
Note
Before you use the delivery set (the tubing, the
syringe, and stopcocks), make sure it is within
the specified use period of the manufacturer.
Many sets are made to be used only once.
Connect Drains
Follow these recommendations when you connect the
drain tubes to the Product outlets:
• Do not allow the drain tubes 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.
Product Maintenance
Warning
To prevent possible electrical shock, fire, or
personal injury:
• Batteries contain hazardous chemicals
that can cause burns or explode. If
exposure to chemicals occurs, clean
with water and get medical aid.
• Do not disassemble the battery.
• Do not disassemble or crush battery
cells and battery packs.
• Do not put battery cells and battery
packs near heat or fire. Do not put in
sunlight.
• Do not short the battery terminals
together.
• Do not keep cells or batteries in a
container where the terminals can be
shorted.
8
Infusion Device Analyzer
Product Maintenance
• Remove the input signals before you
clean the Product.
• Use only specified replacement parts.
• Have an approved technician repair the
Product.
For safe operation and maintenance of the
product:
• Repair the Product before use if the
battery leaks.
• Be sure that the battery polarity is
correct to prevent battery leakage.
• Use only Fluke approved power adapters
to charge the battery.
After troubleshooting or maintenance, restart the Product
and ensure it starts without errors.
Clean the Product (Outside)
To clean the outside of the Product, disconnect from the
power supply and use only a damp cloth with mild
detergent.
Clean the Product (Inside)
It is possible that microbial growth can become present in
the measuring module of the Product. It is recommended
that you clean the fluid paths 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.
9
IDA-1S
Getting Started Manual
Test Fluid
The Product operates with distilled or de-ionized water
with added detergent. Fluids intended for use on patients,
high viscosity fluids, oily, or corrosive substances will
cause damage to the measurement system. Tap water
can contain contaminates that can cause damage to the
fluid paths.
You can make test fluid with de-ionized water and a
wetting agent such as MICRO-90. Fluke recommends
that you prepare a 0.1 % solution of MICRO-90 in deionized water (preferably degassed) in volume for daily
use. Keep the solution in a sealed container. If the
solution makes too much foam, then you can use a
0.05 % dilution.
MICRO-90 is available from International Product Corp.
For ordering information, see the IDA-1S Users Manual.
Storage
Remove all water from the Product before storage,
especially 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.
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, 40 cm x 30 cm
x 20 cm).
10
Infusion Device Analyzer
General Specifications
General Specifications
Battery Power ........... 4 x Panasonic HHR210AB NiMh
2000 mAh batteries
Charger
Operating Voltage
Range ..................... 100 V ac to 240 V ac
Supply Frequency ... 50 Hz / 60 Hz
Supply Power ......... <20 VA
Size (HxWxD) ............ 30 cm x 17 cm x 10 cm (12 in x
8 in x 4 in)
Weight ....................... ~1.2 kg (2.7 lb)
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
Altitude ...................... 0 meters to 2000 meters
(6500 feet)
Safety ........................ IEC 61010-1: Overvoltage
category II, Pollution Degree 2
Electromagnetic
Environment .............IEC 61326-1: Basic
Emissions
Classification ............IEC CISPR 11: Group 1, Class A.
(Group 1 have intentionally generated 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 nondomestic locations and/or directly connected to a lowvoltage power supply network.)
FCC ............................CFR47: Class A Part 15 subpart B
Storage of Results ....Test results stored for later
viewing, printing or transfer to PC.
Typical practical capacity:
100 tests
Power Down ..............The results of tests in progress will
be saved in the case of accidental
power down
Computer Control .....The Product can be fully controlled
from a PC using HydroGraph
software
11
IDA-1S
Getting Started Manual
Performance Specifications
Average Flow Rate Measurement
Technique .............. Flow is calculated by measuring
volume over time
Range .................... 0.5 ml/h to 1000 ml/h
Accuracy ................ 1 % of reading ±1 LSD for flows of
16 ml/h to 200 ml/h for volumes
over 20 ml; otherwise 2 % of
reading ±1 LSD for volumes over
10 ml under laboratory conditions
Max test duration .... 10 hours on battery
Volume Measurement
Technique .............. Volume is measured directly by the
measuring module in minimum
sample sizes of 60 µl
Range .................... 0.06 ml to 999 ml
Accuracy ................ 1 % of reading ±1 LSD for flow
rates of 16 ml/h to 200 ml/h for
volumes over 20 ml. Otherwise
2 % of reading ±1 LSD for volumes
over 10 ml under laboratory
conditions
Max test duration .... 10 hours on battery
Pressure Measurement
Technique
(Occlusion test) ...... Direct measurement of pressure at
the inlet port
Range ..................... 0 psi to 45 psi and equivalent in
mmHg, Bar and kPa
Accuracy ................ 1 % of Full Scale ±1 LSD under
laboratory conditions
Max test duration .... 30 minutes
For a complete list of specifications see the IDA-1S Users
Manual.
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