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INCU
Operators Manual
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: 775.883.9541
Sales E-Mail: sales@flukebiomedical.com
Service: 888.993.5853
Service Fax: 775.886.6320
Service E-mail: techservices@flukebiomedical.com
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.
ii
Incubator Analyzer
Notices, Warranty and Contents
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
I P 30
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
Class of protection see Appendix A
iii
INCU
Operators Manual
Hazard Warnings
☛ Warning! Power Rating. The INCU mains power input must be connected using an
☛ Warning! Internal Voltage. Always turn off the power switch and unplug the power
☛ Warning! Liquids. Avoid spilling liquids on the analyzer; fluid seepage into internal
☛ Warning! “Do not use in the presence of oxygen”. The Air Flow sensor is hot wire
☛ Warning! “Use only approved battery charger." The INCU contains a lead-acid
Precautions
The following precautions are provided to help you avoid damaging the system:
☛ Caution: Service. Authorized service personnel should service the INCU. Only
☛ Caution: Environmental Conditions. Do not expose the system to temperature
☛ Caution: Do NOT Immerse. Clean only with a mild detergent, and gently wipe down
☛ Caution: Electromagnetic radiation may affect the noise measurement.
external power supply that provides voltage and current within the specified rating for
the system.
cord before cleaning the outer surface of the INCU.
components creates a potential shock hazard. Do not operate the instrument if
internal components are exposed to fluid.
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.
rechargeable battery. Use only the approved charger with proper voltage and current
ratings; otherwise, damage to the unit may result.
qualified technical personnel should perform troubleshooting and service procedures
on internal components.
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.
with a clean, lint-free cloth.
iv
Incubator Analyzer
Notices, Warranty and Contents
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.
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
Based on the testing standards below,
this device bears the
mark.
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).
vi
Incubator Analyzer
Notices, Warranty and Contents
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.
vii
INCU
Operators Manual
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
viii
Incubator Analyzer
Notices, Warranty and Contents
Contents
Notices ................................................................................................................... ii
Restrictions and Liabilities ........................................................................ ii
All Rights Reserved................................................................................... ii
Figure B-2. Sample History Graph Sheet .......................................................... B-4
Figure B-3. Sample Parameter Numerical List .................................................. B-5
View of Left Side of INCU.................................................................1-5
xi
INCU
Operators Manual
xii
Chapter 1: Overview
1
Inside This Chapter
• Introducing INCUTM
TM
• INCU
• Getting to Know INCU
• AAMI/IEC Standards
• Accessories
Measurements
TM
1-1
INCU
Operators Manual
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.
Two Modes of Operation: Operates stand-alone or fully
•
functioning, requiring a computer.
1-2
Incubator Analyzer Getting to Know the INCU
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.
Figure 1-1. Closed incubator with forced convection
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
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 1-2. Infant warmer
provides, in a single unit, the
1-3
INCU
Fig
Operators Manual
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.
ure 1-3. INCU sensors
• 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.
1-4
Incubator Analyzer
Fig
Fig
AAMI/IEC Standards
ure 1-4. View of right side of INCU
• Sound Sensor: Internal Microphone used for sound measurements.
Temperature Sensor T4: Used for Mattress Temperature
•
Measurements, made by conduction.
INCU
INCUBATOR ANALYZER
RS 232
Port
RS 232
DO NOT USE WITH OXYGEN
NE PAS UTILISER EN PRESENCE
D'OXYGENE
Power
DC in Jack
On/Off Switch
ure 1-5. View of left side of INCU
• 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.
•
1-5
INCU
Operators Manual
AAMI/IEC Standards
The AAMI and IEC standards specify sound levels, CO2 concentration, 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
Note:
Note:
For up-to-date standards, please visit AAMI.org or IEC.org.
The following are examples of standards for description
proposed. Please reference the current application to determine
your testing protocol.
INCU Applications
The following section provides information describing how INCU
can be
used to perform testing in consideration of the standards.
Temperature – Standard: During steady state condition, the
1.
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.
Temperature - Standard: The AVERAGE TEMPERATURE in each
2.
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).
1-6
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.
Incubator Analyzer AAMI/IEC Standards
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.
Temperature - Standard: Working as an air-controlled INCUBATOR,
5.
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.
Temperature - Standard: The warm-up time of the equipment shall not
6.
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.
Temperature - Standard: After adjusting the temperature from 30°C to
7.
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.
Standard: Any indicated value of relative humidity shall have an
8.
accuracy of ±10% (±15% transportable) of the actual measured value.
INCU: Read the value and compare it with the set value.
Sound Pressure - Standard: In normal use, the sound level within the
9.
baby compartment shall not exceed 60 dB except as specified in 102.2.
INCU: Read the value and compare it with the threshold.
Sound Pressure - Standard: When any incubator alarm is sounding,
10.
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.
Sound Pressure - Standard: Audible alarms shall have a sound level of
11.
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.
1-7
INCU
Operators Manual
Accessories
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.
The following accessories are available for your INCUIncubator Analyzer.
Description Part No.
DB9 Serial Cable 2238834
Transport Bag 2248900
Radiant Baby Assembly 2239002
Outside Temperature Probe Holder 2213928
Service Manual 2206983
1-8
Chapter 2: Installation
2
Inside This Chapter
• Unpacking and Inspection
TM
• Connecting INCU
• PC Software System Requirements
• Installing the PC Software
2-1
INCU
Operators Manual
Unpacking and Inspection
Before unpacking the INCU, visually inspect the shipping box for damage.
If no damage is evident, unpack the INCU and use the checklist below to
ensure that you have received the instrument accessories. Save the foam
inserts and shipping box. You must use the original packing materials when
shipping the INCU for service or re-calibration. If the original shipping
carton and packing materials are not available, call a Fluke service
representative for assistance.
If the shipping box is damaged, unpack the analyzer and inspect it for visible
defects.
If the instrument is damaged, notify the carrier and your local dealer or
service center. Keep the shipping cartons and packing materials for the
carrier's inspection. Call a Fluke service representative to arrange for repair
or replacement of your instrument without waiting for the claim against the
carrier to be settled.
After unpacking the INCU, use the following checklist to ensure that you
have received everything. In addition to the analyzer and this manual
(P/N 3901000), you should have the following:
• A Transport Bag, P/N 2248900
• An Air Flow Sensor, P/N 2239025
• PC Software CD ROM, P/N 2213919
• AC Battery Charger with Country Adapters for the USA, Europe,
Australia, or the UK, P/N 2213937
• 9-Pin to 9-Pin Serial Cable, P/N 2238834
• Temperature Probe Holder, P/N 2213928
• Radiant Baby Assembly, P/N 2239002
• Certificate of Calibration
• Declaration of Conformity
• Fluke Biomedical Warranty Card Information
2-2
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