Fluke Biomedical INCU User manual

INCUTM
Incubator Analyzer
Operators Manual
PN 2206965
April 2005
© 2005 Fluke Corporation All rights reserved. Printed in USA
All product names are trademarks of their respective companies.

INCU
Operators Manual
ii
Notices
Fluke Biomedical
6920 Seaway Blvd.
Everett, WA 98203
USA
Customer Service and Sales
USA and Canada:800.648.7952
Outside the USA: 775.883.3400
Sales Fax: [phone]
Sales E-Mail: [email protected]
Service: 888.993.5853
Service Fax: [phone]
Service E-mail: [e-mail]
Internet: www.flukebiomedical.com
For additional sales or service information, contact your local Fluke Biomedical Distributor or Fluke
Electronics office.
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.
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.

Incubator Analyzer
Notices, Warranty and Contents
iii
Safety Considerations
Warnings and Cautions
Use of this instrument is restricted to qualified personnel who recognize shock hazards and are
familiar with safety precautions used when operating electrical equipment. Read the manual carefully
before operating the INCU.
☛The following warning and informational symbols may be found on the INCU.
Symbol Description
Alternating Current
Caution: Refer to accompanying
documentation
Master ON/OFF,switch. Push for OFF or ON
Direct / Alternating Current
Direct Current
Enclosure with double insulation or reinforced
insolution
Fuse
I P 30 Class of protection see Appendix A

INCU
Operators Manual
iv
Hazard Warnings
☛Warning! Power Rating. The INCU mains power input must be connected using an
external power supply that provides voltage and current within the specified rating for
the system.
☛Warning! Internal Voltage. Always turn off the power switch and unplug the power
cord before cleaning the outer surface of the INCU.
☛Warning! Liquids. Avoid spilling liquids on the analyzer; fluid seepage into internal
components creates a potential shock hazard. Do not operate the instrument if
internal components are exposed to fluid.
☛Warning! “Do not use in the presence of oxygen”. The Air Flow sensor is hot wire
technology and is a source of combustion if used in the presence of oxygen within
the incubator. Use the INCU only in ambient oxygen conditions.
☛Warning! “Use only approved battery charger." The INCU contains a lead-acid
rechargeable battery. Use only the approved charger with proper voltage and current
ratings; otherwise, damage to the unit may result.
Precautions
The following precautions are provided to help you avoid damaging the system:
☛Caution: Service. Authorized service personnel should service the INCU. Only
qualified technical personnel should perform troubleshooting and service procedures
on internal components.
☛Caution: Environmental Conditions. Do not expose the system to temperature
extremes. Ambient temperatures should remain between 18°C to 40°C. System
performance may be adversely affected if temperatures fluctuate above or below this
range.
☛Caution: Do NOT Immerse. Clean only with a mild detergent, and gently wipe down
with a clean, lint-free cloth.
☛Caution: Electromagnetic radiation may affect the noise measurement.

Incubator Analyzer
Notices, Warranty and Contents
v
Applicable Testing Standards
The INCU has been tested by an independent laboratory and meets the requirements listed here.
Safety Requirements
EC Directive
73/23/EEC
IEC 1010-1, Safety requirement for electrical equipment for
measurement, control and laboratory use, Part 1: General
Requirements.
North America Battery Charger is UL marked.
Electromagnetic Interference and Susceptibility
The system meets the requirements of EC Directive 89/336/EEC Electromagnetic Compatibility (see
page viii).
☛USA FCC Class A
Warning: Changes or modifications to this unit not expressly approved by the manufacturer could
void the user's authority to operate the equipment.
This equipment has been tested and found to comply with the limits for a Class A digital device,
pursuant to Part 15 of the FCC Rules.
These limits are designed to provide reasonable protection against harmful interference when the
equipment is operated in a commercial environment. Like all similar equipment, this equipment
generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance
with the instruction manual, may cause harmful interference to radio communications. Operation of
this equipment in a residential area is likely to cause interference, in which case the user will be
required to correct the interference at his/her own expense.
☛Canadian Department of Communications Class A
This digital apparatus does not exceed Class A limits for radio emissions from digital apparatus set
out in the Radio Interference Regulations of the Canadian Department of Communications.
Le present appareil numerique n'met pas du bruits radioelectriques depassant les limites applicables
aux appareils numerique de la Class A prescrites dans le Reglement sur le brouillage radioelectrique
edicte par le ministere des Communications du Canada.

INCU
Operators Manual
vi
Based on the testing standards below,
this device bears the
mark.
EC Directive 89/336/EEC Electromagnetic Compatibility
☛Emissions - Class B
NFEN 55022 Class B (12/94) Radio disturbance
☛Immunity
The system has been type tested by an independent, accredited testing laboratory and found to meet
the requirements for Immunity. Verification of compliance was conducted to the limits and methods of
the following:
EN 61000-4-2 (1995) Electrostatic Discharge
EN 61000-4-3 (1984) Radiated EM Fields (electromagnetic radiation may affect the noise
measurement)
EN 61000-4-4 (1995) Electrical Fast Transient/Burst
EN 61000-4-5 (1995) Surge Immunity
EN 61000-4-6 (1996) Conducted Disturbances
EN 61000-4-11 (1994) Voltage Dips, Short Interruptions and Variations (N/A; Battery buffers
transients)
EC Directive 73/23/EEC Low Voltage (User Safety)
The system has been type tested by an independent testing laboratory and found to meet the
requirements of EC Directive 73/23/EEC for Low Voltage. Verification of compliance was conducted
to the limits and methods of the following:
IEC 1010-1 1990 and Amendments 1 1992 and Amendments 2 1995
“Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use,
Part 1: General requirements” (including amendments 1 and 2).

Incubator Analyzer
Notices, Warranty and Contents
vii
Warranty
This Warranty is limited and applies only to new products, except for computer-based software, which
is covered under a separate Warranty Policy, manufactured by Fluke Biomedical. Fluke Biomedical
makes no warranty whatsoever regarding the condition of used products.
Fluke Biomedical warrants the instrument (hereinafter collectively referred to as “Products” or
“Product”) for a period of one (1) year from the original purchase date against defective materials or
workmanship. This Warranty is limited to the original purchaser (the “Purchaser”) and cannot be
assigned or transferred. All claims under this Limited Warranty must be made in writing to Fluke
Biomedical, Attention: Service Department. Purchaser must ship the Product to Fluke Biomedical,
postage pre-paid. Fluke Biomedical shall either repair or replace with new or like new, at its option
and without cost to the Purchaser, any Product which in Fluke Biomedical’s sole judgment is
defective by reason of defects in the materials or workmanship.
This Warranty is VOID if the Product has been damaged by accident or misuse, or has been
damaged by abuse or negligence in the operation or maintenance of the Product, including without
limitation unsafe operation, operation by untrained personnel, and failure to perform routine
maintenance. This Warranty is VOID if the Product has been repaired or altered by persons not
authorized by Fluke Biomedical, or if the Product has had the serial number altered, effaced, or
removed. This Warranty is VOID if any of the Products has not been connected, installed or adjusted
strictly in accordance with written directions furnished by Fluke Biomedical. Batteries, fuses, light
bulbs, and other “consumable” items used in any of the Products are not covered by this Warranty.
Software utilized in conjunction with any of the Products is not covered by the terms of this Warranty
but may be covered under a separate Fluke Biomedical software warranty.
We will continue to stock parts for a maximum period of five (5) years after the manufacture of any
equipment has been discontinued. Parts shall include all materials, charts, instructions, diagrams,
and accessories that were furnished with the standard models.
THIS WARRANTY CONTAINS THE ENTIRE OBLIGATION OF FLUKE BIOMEDICAL, AND NO
OTHER WARRANTIES, EXPRESSED, IMPLIED, OR STATUTORY ARE GIVEN. PURCHASER
AGREES TO ASSUME ALL LIABILITY FOR ANY DAMAGES AND/OR BODILY INJURY OR DEATH
THAT MAY RESULT FROM THE USE OR MISUSE OF ANY EQUIPMENT OR INSTRUMENT BY
THE PURCHASER, HIS EMPLOYEES, AGENTS, OR CUSTOMERS, OTHER THAN THE EXPRESS
WARRANTY CONTAINED HEREIN. WE SHALL NOT BE RESPONSIBLE FOR ANY DIRECT OR
CONSEQUENTIAL DAMAGES OF ANY KIND. THIS WARRANTY SHALL NOT BE CHANGED OR
MODIFIED IN ANY WAY WITHOUT THE EXPRESS WRITTEN PERMISSION OF AN OFFICER OF
FLUKE BIOMEDICAL.
THIS WARRANTY IS VOID UNLESS THE PURCHASE REGISTRATION CARD HAS BEEN
COMPLETED AND MAILED TO US WITHIN TEN (10) DAYS OF PURCHASE.

INCU
Operators Manual
viii
About This Manual
This manual provides a complete description of the INCU Incubator Analyzer and its applications.
The manual is organized as follows:
•Chapter 1, Overview: An introduction to the INCU and optional accessories
•Chapter 2, Installation: How to connect the INCU and install the PC software
•Chapter 3, General Operation: INCU keypad functions, setup, and stand-alone operation
•Chapter 4, PC Software Operation:PC software operation
•Chapter 5, Safety, Displayed Messages, Troubleshooting, and Support
•Appendix A, INCU Specifications
•Appendix B, INCU Report Examples
•Appendix C, DAT File Format

Incubator Analyzer
Notices, Warranty and Contents
ix
Contents
Notices ................................................................................................................... ii
Restrictions and Liabilities ........................................................................ ii
All Rights Reserved................................................................................... ii
Safety Considerations............................................................................................iii
Warnings and Cautions............................................................................ iv
Hazard Warnings............................................................................... iv
Precautions........................................................................................ iv
Applicable Testing Standards ................................................................................ v
Safety Requirements ................................................................................ v
Electromagnetic Interference and Susceptibility....................................... v
EC Directive 89/336/EEC Electromagnetic Compatibility................... vi
Emissions............................................................................................ vi
Immunity ............................................................................................. vi
EC Directive 73/23/EEC Low Voltage (User Safety) ............................... vi
Warranty............................................................................................................. vivii
About This Manual ...............................................................................................viii
Chapter 1: Overview ................................................................................ 1-1
Introducing the INCU™.......................................................................................1-2
INCU Measurements...........................................................................................1-3
Getting to Know the INCU...................................................................................1-4
AAMI/IEC Standards ...........................................................................................1-6
INCU Applications ..................................................................................1-6
Accessories.........................................................................................................1-8
Chapter 2: Installation ............................................................................. 2-1
Unpacking and Inspection...................................................................................2-2
Connecting INCU ................................................................................................2-3
AC-DC Battery Charger Connection ......................................................2-3
Internal Battery.......................................................................................2-3
RS-232 Port ...........................................................................................2-3
Air Flow Sensor......................................................................................2-4
Radiant Baby Assembly.........................................................................2-4
PC Software System Requirements ...................................................................2-5
Installing the PC Software...................................................................................2-6
Installing the Software............................................................................2-6

INCU
Operators Manual
x
Chapter 3: General Operation................................................................. 3-1
INCU Keypad Functions ..................................................................................... 3-2
Key Details............................................................................................. 3-3
INCU Setup......................................................................................................... 3-5
Placement of the INCU in the Incubator................................................ 3-5
Infant Radiant Warmers......................................................................... 3-9
INCU Operation ................................................................................... 3-10
Chapter 4: INCU PC Software Operation ............................................... 4-1
Introduction ......................................................................................................... 4-2
Configuring the INCU for Data Acquisition ......................................................... 4-2
Data Acquisition.................................................................................................. 4-4
Transferring Data to the PC Software ................................................................ 4-5
Graphs ................................................................................................................ 4-7
Software Options ................................................................................................ 4-8
Open Files ............................................................................................. 4-8
Save Files .............................................................................................. 4-8
Printer Configuration.............................................................................. 4-8
Print Folder ............................................................................................ 4-8
Cascade................................................................................................. 4-9
Heading ............................................................................................... 4-10
Graph Colors ....................................................................................... 4-11
Com Port.............................................................................................. 4-12
Language............................................................................................. 4-12
Zoom.................................................................................................... 4-13
Chapter 5: Safety, Displayed Messages, Troubleshooting,
and Support........................................................................... 5-1
Electrical Safety .................................................................................................. 5-2
Cleaning................................................................................................. 5-2
Air Flow Sensor ..................................................................................... 5-2
Displayed Messages .......................................................................................... 5-3
Troubleshooting.................................................................................................. 5-4
Support ............................................................................................................... 5-6
Appendix A: Specifications ....................................................................A-1
Appendix B: Report Examples ...............................................................B-1
Appendix C: DAT File Format.................................................................C-1

Incubator Analyzer
Notices, Warranty and Contents
xi
List of Illustrations
Figure 1-1. Closed Incubator With Forced Convection.......................................1-3
Figure 1-2. Infant Warmer...................................................................................1-3
Figure 1-3. Descriptions and Locations of INCU Sensors ..................................1-4
Figure 1-4. View of Right Side of INCU ..............................................................1-5
Figure 1-5. View of Left Side of INCU.................................................................1-5
Figure 2-1. Radiant Baby Assembly ...................................................................2-4
Figure 2-2. INCU Setup Screen ..........................................................................2-6
Figure 3-1. The INCU Front Panel ......................................................................3-2
Figure 3-2. INCU Keypad Display.......................................................................3-3
Figure 3-3. INCU Inside a Closed Incubator.......................................................3-5
Figure 3-4. Placement of Temperature Sensors T1-T3 ......................................3-6
Figure 3-5. Placement of Air Flow Sensor ..........................................................3-7
Figure 3-6. Placement of Temperature Sensor T4 .............................................3-8
Figure 3-7. Placement of an INCU Inside an Infant Warmer ..............................3-9
Figure 3-8. Placement of a Radiant Baby Adapter on Top of the INCU .............3-9
Figure 3-9. Data Acquisition Mode Screen .......................................................3-11
Figure 4-1. PC Interconnected With the INCU....................................................4-2
Figure 4-2. Using the Config Menu .....................................................................4-3
Figure 4-3. INCU Keypad Display.......................................................................4-4
Figure 4-4. INCU File Transfer Menu..................................................................4-5
Figure 4-5. INCU Comments Entry Window .......................................................4-6
Figure 4-6. INCU Parameter Options Menu........................................................4-7
Figure 4-7. INCU Parameter Screen...................................................................4-7
Figure 4-8. INCU File Menu Screen....................................................................4-8
Figure 4-9. INCU Window Menu Screen.............................................................4-9
Figure 4-10. INCU Parameters Menu Screen.....................................................4-9
Figure 4-11. INCU Heading Screen ..................................................................4-10
Figure 4-12. INCU Graph Colors Screen ..........................................................4-11
Figure 4-13. INCU Communication Menu Screen ............................................4-12
Figure 4-14. INCU Language Menu Screen .....................................................4-12
Figure 4-15. INCU Zoom Menu Screen ............................................................4-13
Figure 4-16. INCU Zoom on Window Screen ...................................................4-13
Figure B-1. Sample Monitoring Sheet................................................................ B-3
Figure B-2. Sample History Graph Sheet .......................................................... B-4
Figure B-3. Sample Parameter Numerical List .................................................. B-5

INCU
Operators Manual
xii

1-1
Chapter 1: Overview
Inside This Chapter
•Introducing INCUTM
•INCUTM Measurements
•Getting to Know INCUTM
•AAMI/IEC Standards
•Accessories
1

INCU
Operators Manual
1-2
Introducing INCUTM
The INCU Incubator Analyzer is a portable device designed to verify the
proper operation and environment of infant incubators. This unit records
parameters important to the care of infants over time, such as airflow, sound
level, temperature (four individual measurement probes), and relative
humidity. Event markers can be placed on the recording to identify certain
activities or periods. The rechargeable battery allows the unit to be placed
within the incubator chamber for up to 24 hours without compromising the
integrity of the environment.
The INCU can operate stand-alone or with the use of a personal computer.
With a PC, the user selects the desired record time/interval via the software,
and then initiates the start of the test from the INCU. After completion of the
test, the user uploads the data collected by INCU into the PC software for
display and analysis. The user may store the recorded data in a file or print
the data to a report. In stand-alone mode, the unit displays all measured
parameters repeatedly in cycle fashion, and no data is recorded.
Features on the INCU include:
•Portability: Sits in place of the infant within the incubator.
•Multiple Sensors: Measures and documents multiple key infant
incubator parameters simultaneously.
•Compliance: Measures most parameters according to IEC and
AAMI standards.
•Efficient: Saves time in testing critical infant incubators.
•Data Collection: Uses Microsoft®Windows®software for
evaluation and documentation.
•Reporting: Allows printing of numerical and graphical reports.
•Recording Flexibility: Provides adjustable measurement intervals.
•Two Modes of Operation: Operates stand-alone or fully
functioning, requiring a computer.

Incubator Analyzer
Getting to Know the INCU
1-3
INCU is to be used by service personnel or Biomedical institutions to verify
and test infant incubators. INCU is designed to support testing of two types
of incubators, as shown in Figures 1-1 and 1-2.
INCU Measurements
INCU is an autonomous acquisition system that is used to measure and save
the operational parameters of an empty incubator, and then transmit data via
a serial communications port. INCU provides, in a single unit, the
measurement systems that allow you to record the multiple parameters
simultaneously.
The following measurement parameters are recorded:
Temperature – 4 Sensors T1-T4
Relative Humidity – 1 Sensor
Air Flow – 1 Sensor
Sound – 1 Sensor
See Appendix A, Specifications for performance specifications.
Figure 1-1. Closed incubator with forced convection Figure 1-2. Infant warmer

INCU
Operators Manual
1-4
Getting to Know the INCU
Sensors are integrated and stored within INCU. Open INCU by releasing the
latch on the top cover. Fold the covers open to expose the sensors when
taking measurements. Figure 1-3 shows the location of each sensor.
•Temperature Sensor T1: Used for Convection measurements.
•Temperature Sensor T2: Used for Convection or Radiant
measurements; used with radiant baby adapter supplied with INCU.
•Temperature Sensor T3: Used for Convection measurements.
•Relative Humidity: Located in right top cover (cover must be open
for proper measurements).
•Air Flow: Detachable for storage.
•ON/OFF Switch: Top cover engages this switch to turn power off to
INCU automatically, if the master On/Off switch is left in the ON
position and the top covers are closed (master switch is on the left
side of the exterior).
•Temperature Probe Holder: Used to hold temperature probe T2
when taking convection measurements. This is a mechanical
connection only; there is no electrical connection.
F
i
g
ure 1-3. INCU sensors

Incubator Analyzer
AAMI/IEC Standards
1-5
•Sound Sensor: Internal Microphone used for sound measurements.
•Temperature Sensor T4: Used for Mattress Temperature
Measurements, made by conduction.
INCU
INCUBATOR ANALYZER
DO NOT USE WITH OXYGEN
NE PAS UTILISER EN PRESENCE
D'OXYGENE
RS 232
RS 232
Port
Power
DC in Jack
On/Off Switch
•RS-232 Port: 9 Pin D Sub type Male Connector.
•Power DC IN Jack: Use only the specified charger. AC-DC 6V
600 mA.
•Master On/Off Switch: Push for OFF or ON.
F
i
g
ure 1-4. View o
f
ri
g
ht side o
f
INCU
F
i
g
ure 1-5. View o
f
le
f
t side o
f
INCU

INCU
Operators Manual
1-6
AAMI/IEC Standards
The AAMI and IEC standards specify sound levels, CO2concentration, and
thermal characteristics for incubators. The standards are used by
manufacturers when designing and manufacturing incubators. INCU was
designed with consideration of the standards, and can perform testing to
satisfy many testing requirements.
Incubator Standards
Standard# Description
IEC 601-2-19 Infant Incubator Tester Safety Requirements
IEC 601-2-20 Safety Requirements for Transport Incubators
IEC 601-2-21 Infant Radiant Warmer Standard
ANSI/AAMI 1136-1997 Infant Incubators
INCU Applications
The following section provides information describing how INCU can be
used to perform testing in consideration of the standards.
1. Temperature – Standard: During steady state condition, the
INCUBATOR TEMPERATURE shall not differ from the AVERAGE
INCUBATOR TEMPERATURE by more than 0.5°C (1°C transportable)
during at least 1 hour at the control temperatures of 32°C and 36°C.
INCU: The user shall check the oscillation from min to max in steady
state.
2. Temperature - Standard: The AVERAGE TEMPERATURE in each
point A,B,C,D,E, shall not differ from the AVERAGE INCUBATOR
TEMPERATURE (test at a set T of 32°C - 36°C) by more than ±0.8°C
(±1.5°C transportable).
INCU: In any position of the tilted mattress, it shall not differ by more
than
± 1.0 ° C ( ± 2.0 ° C transportable). Calculate manually the difference
between the mean value at the center and the other sensors readings.
3. Temperature - Standard: The TEMPERATURE as measured by the
skin temperature sensor shall not differ from a reference sensor
temperature by more than 0.3°C in steady temperature condition.
INCU: Check the difference between the value given by the T2 sensor
and the value displayed by the skin sensor when placed in close
proximity to the T2 sensor.
Note: For up-to-date standards, please visit AAMI.org or IEC.org.
Note: The following are examples of standards for description
proposed. Please reference the current application to determine
your testing protocol.

Incubator Analyzer
AAMI/IEC Standards
1-7
4. Temperature - Standard: The INCUBATOR shall be provided with an
indicator of the internal temperature. The mean value of the reading of
this device shall not differ from the average incubator temperature
measured by a standard thermometer by more than ±0.8°C (±1°C
transportable), less the standard thermometer error. The standard
thermometer shall be accurate within ±0.05°C.
INCU: Check the difference between the value of the mean value at the
center and the one displayed by the indicator.
5. Temperature - Standard: Working as an air-controlled INCUBATOR,
the average INCUBATOR TEMPERATURE shall not differ from the
control temperature by more than ±1.5°C (±2°C transportable).
INCU: Check the difference between the value of the mean value at the
center and the set value.
6. Temperature - Standard: The warm-up time of the equipment shall not
differ by more than 20% from the warm-up time specified in the
instructions for use.
INCU: Check the difference between the time stated by the manufacturer
and the time to raise the temperature by 11 C, starting at the
environmental conditions with a setting temperature 12°C above the
ambient.
7. Temperature - Standard: After adjusting the temperature from 30°C to
34°C or Transit 32°C to 36°C, the overshoot in the incubator temperature
shall not exceed 2°C.
INCU: Calculate the overshoot manually.
8. Standard: Any indicated value of relative humidity shall have an
accuracy of ±10% (±15% transportable) of the actual measured value.
INCU: Read the value and compare it with the set value.
9. Sound Pressure - Standard: In normal use, the sound level within the
baby compartment shall not exceed 60 dB except as specified in 102.2.
INCU: Read the value and compare it with the threshold.
10. Sound Pressure - Standard: When any incubator alarm is sounding,
the sound level within the baby compartment shall not exceed 80 dB.
INCU: Activate an alarm, read the value, and compare it with the
threshold.
11. Sound Pressure - Standard: Audible alarms shall have a sound level of
at least 80 dB at a distance of 3 m perpendicular to the front of the
control unit.
INCU: Activate an alarm, move the INCU outside, read the value, and
compare it with the threshold.

INCU
Operators Manual
1-8
12. Air Flow – Standard: In normal use, air velocity over the mattress shall
not exceed 0.35 m/s.
INCU: Read the value and compare it with the threshold.
Accessories
The following accessories are available for your INCU Incubator Analyzer.
Description Part No.
DB9 Serial Cable 2238834
Transport Bag 2248900
Radiant Baby Assembly 2239002
Outside Temperature Probe Holder 2213928
Service Manual 2206983