Fluke INCU II User manual
PN 4754298 January 2016, Rev. 1
©2016 Fluke Corporation. All rights reserved.
Specifications are subject to change without notification.
All product names are trademarks of their respective companies.
Fluke Corporation
P.O. Box 9090
Everett, WA 98206-9090
U.S.A.
Fluke Europe B.V.
P.O. Box 1186
5602 BD Eindhoven
The Netherlands
ООО «Флюк СИАЙЭС»
125167, г. Москва,
Ленинградский проспект дом 37,
корпус 9, подъезд 4, 1 этаж
INCU™ II Skin Temperature
Heater Assembly
Instructions
Introduction
The INCU™II Skin Temperature Heater Assembly (the Product or Accessory)
uses a controlled temperature environment to test the skin temperature sensors
of incubators or radiant warmers. The Accessory connects to the INCU™II
Incubator Analyzer (the Analyzer). To use the Accessory, see Skin Temperature
Sensor Accuracy.
Intended Use
The intended use for the Analyzer and skin temperature heater is to test in
compliance with standards, perform preventative maintenance, repair
verification, and routine verification of baby incubators and radiant warmers. The
intended user is a trained biomedical equipment technician who performs
periodic preventative maintenance checks on baby incubators and radiant
warmers in service. Users can be associated with hospitals, clinics, original
equipment manufacturers and independent service companies that repair and
service medical equipment. The end user is an individual, trained in medical
instrumentation technology.
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. It is intended for over the counter use. Designed around
AAMI and IEC standards that specify incubator and radiant warmer sound levels,
airflow, and thermal characteristics, the INCU II simultaneously measures airflow,
relative humidity, sound, and five independent temperatures. The skin
temperature heater measures the temperature of the incubator and radiant
warmer skin temperature sensor.
Safety
A Warning identifies hazardous conditions and actions that could cause bodily
harm or death. A Caution identifies conditions and actions that could damage
the Product, the equipment under test, or cause permanent loss of data.
XWWarning
To prevent possible electrical shock, fire or personal injury, follow
these guidelines:
• 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 around explosive gas, vapor, or in damp
or wet environments.
• Do not use the Product if it operates incorrectly.
• Use this Product indoors only.
• Use only the external mains power supply included with the
Product.
• Disable the Product if it is damaged.
• Do not use the Product if it is damaged.
• Do not use a two-conductor mains power cord unless you
install a protective ground wire to the Product ground terminal
before you operate the Product.
• Do not put metal objects into connectors.
• Do not use an extension cord or adapter plug.
Table 1 shows the symbols used on the Product and in this document.
Table 1. Symbols
Symbol Description
WWARNING. RISK OF DANGER.
XWARNING. HAZARDOUS VOLTAGE. Risk of electric shock.
WARNING. HOT SURFACE. Risk of burns.
Consult user documentation.
"Battery polarity
~
This product complies with the WEEE Directive 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.
Skin Temperature Sensor Accuracy
201.12.1.103 (Baby Incubator)
201.12.1.103 (Transport Incubator)
201.12.1.101 (Radiant Warmer)
Use the Accessory to compare the skin temperature sensor indication to a
calibrated temperature sensor.
Pass Criteria
Skin temperature sensor indication = Analyzer measurement ±0.3 °C
Prepare for the Test
To get accurate results:
• Make sure there is a good contact between the skin sensor and the
heater. Use a thermal compound to get the highest accuracy.
• Set the DUT to measure from the skin temperature sensor.
• Put the Accessory on a flat surface next to the Analyzer.
• Put the Accessory in an environment where the temperature is
<30 °C. An environment ≥30°C can decrease the accuracy of the test
due to ambient interference and can decrease predictability of the
rise time.
Procedure
1. Connect the Accessory to the Analyzer.
2. Connect the Accessory to ac power.
Note
Do not push the power button on the Accessory until the Analyzer
prompts you to turn on the Accessory.
3. Attach the skin temperature sensor from the DUT to the heater
assembly.
a. Open the Accessory and put the skin temperature sensor on the
center of the base.
b. Close the Accessory.
4. On the Analyzer:
a. Select the test environment.
b. Select Skin Temperature Sensor Accuracy.
c. Push .
The Analyzer detects the temperature of the Accessory.
If the temperature is <30 °C the Analyzer prompts you to turn on
the Accessory.
If the temperature is ≥30 °C the Analyzer continues to monitor the
temperature. When the temperature is <30 °C the Analyzer
prompts you to turn on the Accessory.
d. On the Accessory, push the power button to turn on the heater.
The Analyzer waits until the temperature is stable and then takes a
measurement.
Note
The test will not start if the temperature is ≥30 °C.
5. On the Analyzer, use and to enter the temperature shown on the
DUT and then push .
Maintenance
The Accessory needs little maintenance or special care. Treat the Analyzer as a
calibrated measurement instrument. Do not drop or cause other mechanical
abuse.
To clean the Accessory, wipe with a damp cloth.
Specifications
Temperature
Operating ........................................... 10 °C to 30 °C
Accuracy ......................................... ±0.05 °C
Display Resolution .......................... 0.01 °C
Storage............................................... -20 °C to 60 °C (-4 °F to 140 °F)
Humidity ............................................. 10 % to 90 % non-condensing
Altitude ................................................... 2000 m
Ingress Protection Rating....................... IP-20
Weight .................................................... 0.2 kg (0.5 lb)
Size ........................................................ 75 mm x 70 cm x 38 cm (2.9 in x
2.7 in x 1.5 in)
Power Adapter – Universal voltage........ Input: 100 V to 240 V with adapters
50/60 Hz.
Output ................................................ 15 V dc, 1.3 A max
Safety
IEC 61010-1....................................... Overvoltage Category none,
Pollution Degree 2
Electromagnetic Compatibility (EMC)
IEC 61326-1: Basic
Emissions Classification..................... IEC CISPR11: 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 low voltage power supply network.
USA (FCC)......................................... Intentional Radiators
This device complies with part 15 of the FCC Rules. Operation is
subject to the following two conditions: (1) This device may not cause
harmful interference, and (2) this device must accept any interference
received, including interference that may cause undesired
operation.(15.19)
Warranty and Product Support
Fluke Biomedical warrants this instrument against defects in materials and
workmanship for one year from the date of original purchase. During the
warranty period, we will repair or at our option replace, at no charge, a
product that proves to be defective, provided you return the product, shipping
prepaid, to Fluke Biomedical. This warranty 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
Fluke Biomedical
6920 Seaway Blvd.
Everett, WA, 98203
U.S.A.
To find the nearest service center, go to www.flukebiomedical.com/service
or:
In the U.S.A. and Asia: In Europe, Middle East, and Africa:
Cleveland Calibration Lab
Tel: 1-800-850-4608 x2564
Email:
Eindhoven Calibration Lab
Tel: +31-40-2675300
Email:
Table of contents
