Fluke Biomedical INCU Operator's Manual

Fluke Biomedical INCU Operator's Manual

Incubator analyzer
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TM
INCU
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.

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Summary of Contents for Fluke Biomedical INCU

  • Page 1 INCU 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.
  • Page 2: Restrictions And Liabilities

    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.
  • Page 3: Safety Considerations

    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...
  • Page 4: Hazard Warnings

    INCU Operators Manual 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.
  • Page 5: Applicable Testing Standards

    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 IEC 1010-1, Safety requirement for electrical equipment for measurement, control and laboratory use, Part 1: General 73/23/EEC Requirements.
  • Page 6: Ec Directive 89/336/Eec Electromagnetic Compatibility

    INCU Operators Manual 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.
  • Page 7: Warranty

    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.
  • Page 8: About This Manual

    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: • An introduction to the INCU and optional accessories Chapter 1, Overview: • How to connect the INCU and install the PC software Chapter 2, Installation: •...
  • Page 9: Table Of Contents

    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...
  • Page 10 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 ......................
  • Page 11 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.
  • Page 12 INCU Operators Manual...
  • Page 13: Chapter 1: Overview

    Chapter 1: Overview Inside This Chapter • Introducing INCU • INCU Measurements • Getting to Know INCU • AAMI/IEC Standards • Accessories...
  • Page 14 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.
  • Page 15: Incu Measurements

    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.
  • Page 16 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.
  • Page 17: Aami/Iec Standards

    Incubator Analyzer AAMI/IEC Standards Figure 1-4. View of right side of INCU • Internal Microphone used for sound measurements. Sound Sensor: • Used for Mattress Temperature Temperature Sensor T4: Measurements, made by conduction. RS 232 DO NOT USE WITH OXYGEN...
  • Page 18: Incu Applications

    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 ± °...
  • Page 19 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. Working as an air-controlled INCUBATOR,...
  • Page 20: Accessories

    Operators Manual In normal use, air velocity over the mattress shall Air Flow – Standard: 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.
  • Page 21: Chapter 2: Installation

    Chapter 2: Installation Inside This Chapter • Unpacking and Inspection • Connecting INCU • PC Software System Requirements • Installing the PC Software...
  • Page 22 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.
  • Page 23: Connecting Incu

    The INCU can operate either on its internal battery or with AC power. Connect the specified adapter to the INCU DC jack on the side of the unit. Plug the opposite end into the AC power source. The universal charger can be plugged into AC power sources ranging from 90 VAC to 240 VAC, 50/60 Hz.
  • Page 24: Air Flow Sensor

    Operators Manual Air Flow Sensor Plug the Air Flow Sensor into the jack on top of the INCU where it is labeled "Air Flow." Ensure that the Air Flow Sensor is installed before attempting to use the INCU. Otherwise, a “Sensor Fault” condition will result, indicating the absence of this sensor.
  • Page 25: Pc Software System Requirements

    Incubator Analyzer Installing the PC Software PC Software System Requirements To utilize the full capabilities of your INCU program, the following minimum environment is required: A PC or portable computer equipped with: • Pentium 133 MHz microprocessor • 16 MB free hard disk space •...
  • Page 26: Installing The Pc Software

    If desired, the language for the PC Software may be selected after installation. 1. Insert the INCU PC Software for Windows CD ROM into the CD ROM drive on your PC. Under Microsoft Windows 95/98/NT, select from the menu.
  • Page 27: Chapter 3: General Operation

    Chapter 3: General Operation Inside This Chapter • INCU Keypad Functions • INCU Setup • INCU Operation...
  • Page 28: Incu Keypad Functions

    INCU Operators Manual INCU Keypad Functions Figure 3-1 illustrates the INCU keypad. The keys and their functions are described on the following pages. RADIANT/ RELATIVE CONVECTION AIR FLOW HUMIDITY DO NOT USE WITH OXYGEN NE PAS UTILISER EN PRESENCE D'OXYGENE...
  • Page 29: Key Details

    1. Press this key for approximately 1 second to begin recording. This function is only active once the INCU has been connected to a PC and a measurement cycle has been initialized. 2. A second display line appears (see Figure 3-2) with the following information: •...
  • Page 30 List (see Appendix B, Report Examples). For an explanation of the significance of each marker, see "Transfer Data to the PC Software" in Chapter 4, INCU PC Software Operation. It is possible to store 5 events. The stored Note: events cannot be deleted.
  • Page 31: Incu Setup

    Figure 3-3 shows the INCU inside a closed incubator. Closed Incubators...
  • Page 32 INCU Operators Manual Figure 3-4 shows the recommended T1, T2, and T3 Convection Sensors: placement for temperature sensors T1-T3 for closed incubators utilizing forced convection. With the sensors mounted to the provided clips, temperature accuracy, response, and uniformity can be monitored throughout the area occupied by the infant at the height of approximately 10 cm above the mattress as specified by standards.
  • Page 33: Figure 3-5. Placement Of Air Flow Sensor

    Air Flow Sensor: The inserted to perform measurements. An error "fault sensor" will be displaced if not inserted or if the Hot Wire is broken in the sensor. The INCU will not perform airflow measurements in this condition. The Air Flow Sensor (Figure 3-5) rotates 360 degrees. For best results, position the Air Flow Sensor perpendicular to the airflow within the incubator.
  • Page 34: Figure 3-6. Placement Of Temperature Sensor T4

    As shown in Figure 3-6, the T4 conduction sensor T4 Conduction Sensor: is fixed and is located on the bottom of the INCU. T4 provides the temperature of the mattress. sound sensor is fixed and is located on the right Sound Sensor (Fixed): The side of the INCU.
  • Page 35: Infant Radiant Warmers

    This adapter must be placed on top of the INCU when testing. Align the adapter with the heater in the warmer. Other temperature sensors (T1, T3) may be used to monitor ambient temperature conditions.
  • Page 36: Incu Operation

    If acquiring data for periods longer than 24 hours, use the AC Charger. Open both covers to expose the INCU panel and display. Push the On/Off switch located on the left-hand-side panel of INCU to turn on the INCU. Note: The INCU is equipped with a secondary On/Off switch on the top panel.
  • Page 37: Figure 3-9. Data Acquisition Mode Screen

    No data is stored within the INCU in Select this mode. The INCU must be configured for using the PC software prior to starting any automated data acquisition. 6. Data Acquisition Mode Using the PC Software After being configured for data acquisition, the INCU will display .
  • Page 38 INCU Operators Manual 3-12...
  • Page 39: Chapter 4: Incu Pc Software Operation

    Chapter 4: INCU PC Software Operation Inside This Chapter • Introduction • Configuring the INCU for Data Acquisition • INCU Data Acquisition • Transferring Data to the PC Software • Graphs • Software Options...
  • Page 40: Introduction

    INCU Operators Manual Introduction The full capability of the INCU is realized when used in conjunction with the provided PC application. The provided PC software for INCU is used to: • Select the measurement interval (1-10) minutes • Select the total recording period (35 hours max) •...
  • Page 41: Data Acquisition

    The measurement interval specifies how often the sensors are sampled for data. That is, if the measurement interval is one minute, all seven INCU sensors are then polled every minute and the results are recorded. 8. To select the recording period, click on the scrolling arrows located...
  • Page 42: Figure 4-3. Incu Keypad Display

    After the INCU is configured for data acquisition, will be displayed. Ready Disconnect the INCU from the PC and place it into an incubator or infant radiant warmer under test as described in Chapter 3. When properly configured and positioned, the INCU is ready for data acquisition.
  • Page 43: Transferring Data To The Pc Software

    Numerical data can be entered into Microsoft® Excel or some other spreadsheet program to customize your own graphs. To initiate a data transfer from the INCU, connect the INCU to a PC running the INCU PC software via the RS-232 port utilizing the supplied RS-232 cable.
  • Page 44: Figure 4-5. Incu Comments Entry Window

    This window allows you to enter comments for or update the monitoring sheet. Figure 4-5. INCU comments entry window At download the user can enter either the start or end of time of the acquisition by clicking on the checkbox. Use the two scrollbars to specify the hour and the minutes.
  • Page 45: Graphs

    This menu is accessible after the recorded data has been loaded. When the graph menu option is selected, four parameters are displayed. Figure 4-6. INCU parameter options menu When a parameter is selected, a window is displayed presenting data in graphical form (see Appendix B for examples of graphs).
  • Page 46: Software Options

    Operators Manual Software Options INCU PC menu features shown in Figure 4-8 are described below. File Figure 4-8. INCU File menu screen Open Files To open a document: 1. In the name field, click on the drive containing the document.
  • Page 47: Cascade

    Vertical tile position windows from top to bottom without any overlap, click on the menu, and then click on Window Horizontal Tile Figures 4-10 through 4-14 show the INCU PC menu features, Parameters described below. Figure 4-10. INCU Parameters menu screen...
  • Page 48: Heading

    INCU Operators Manual Heading Figure 4-11. INCU Heading screen This menu is used to customize the . All fields shown in monitoring sheet red must be completed when you enter this menu. • Site name • Address • Department name •...
  • Page 49: Graph Colors

    Figure 4-12. INCU Graph colors screen Use this menu to apply the color of each graph from 15 available colors. The key allows you to set the background color of the INCU window. Desk When you exit the INCU program, your choices are automatically saved in the file setup.cfg...
  • Page 50: Com Port

    This menu allows you to select the serial communications port (Com). Com2 port is the default. Select the Com1, 3,or 4 port as shown in Figure 4-13. When you exit the INCU program, your setup.cfg. choices are saved in the file Language Figure 4-14.
  • Page 51: Zoom

    2. Zoom Y for the vertical axis (y-coordinate). Zoom X Figure 4-16. INCU Zoom on window screen This command is active when a graph is displayed. It allows for inspection of a small interval of the total acquisition time. Maximum zoom is equal to 30 times the sample interval.
  • Page 52 INCU Operators Manual 4-14...
  • Page 53: Chapter 5: Safety, Displayed Messages, Troubleshooting, And Support

    Chapter 5: Safety, Displayed Messages, Troubleshooting, and Support Inside This Chapter • Electrical Safety and Maintenance • Displayed Messages • Troubleshooting • Support...
  • Page 54: Electrical Safety

    No other solvents are recommended. Air Flow Sensor The Air Flow Sensor has been calibrated for use with each INCU. If an Air Flow Sensor is lost or misplaced, the unit must be returned to the factory or to a certified service center for recalibration.
  • Page 55: Displayed Messages

    Ready Displayed after a new configuration has been sent from the PC software and stored in the INCU unit. Fault Sensor There is an error with the subject sensor. Refer to Chapter 5 to determine corrective action for each...
  • Page 56: Troubleshooting

    Master ON/OFF switch Push switch to turn the on side panel not turned INCU on. INCU does not RS-232 cable not Verify that the INCU is communicate with the plugged in. connected properly. computer Incorrect cable Verify the cable used to connect the RS-232 is a straight-through cable.
  • Page 57: Support

    PC using the PC Software program. The stop key was All data is stored in the pressed prior to INCU up to the point of the completion of the desired low battery message. recording cycle. Transfer the results to the PC using the PC Software program.
  • Page 58 INCU Operators Manual Support Troubleshooting If your new INCU fails to operate successfully, call or e-mail Fluke's Service Department for assistance. Service Before returning the INCU for factory service, contact Fluke's Service Department for further information. Phone: 888.993. 5853 Fax: 425.446.5560...
  • Page 59: Appendix A: Specifications

    Appendix A: Performance Specifications Inside This Appendix • Performance Specifications...
  • Page 60 INCU Operators Manual Performance Specifications This appendix provides the device specifications for the INCU Incubator Analyzer. For more information, please contact your Fluke Biomedical Service representative. Temperature Measurements Conduction: 1 sensor in contact with mattress (bottom of unit) Convection (Inside the incubator):...
  • Page 61 Incubator Analyzer Performance Specifications Noise Measuring Range: 30- 80 dbA Resolution: 0.1 dbA ±5 dbA @ 30-80 dbA Accuracy: Display 2 x 16 Super Twist LCD Measuring Interval Via PC: Adjustable from 1 to 10 minutes Internal Memory Capacity: 1470 measurements (210 records of 7 parameters) Supply Power Requirements:...
  • Page 62 INCU Operators Manual Protection Factor: IP 30 The first index digit -3 means that the unit is protected from object access of solid foreign matter larger than 2.5 mm in diameter. The second index digit - 0 means no protection.
  • Page 63: Appendix B: Report Examples

    Appendix B: Report Examples Inside This Chapter • Monitoring Sheet • History Graph Sheet • Parameter Numerical List...
  • Page 64 Operators Manual Report Examples This appendix provides examples of reports (Figures B-1 through B-3) that can be generated and/or printed from the INCU Incubator Analyzer. Refer to Chapter 4, INCU PC Software Operation for details on how to print these reports.
  • Page 65: Figure B-1. Sample Monitoring Sheet

    Start time of the acquisition : 08:24:00 Department name : Procedure no. : Information : Check : Successful [ ] Failed [ } Operator name : Operator name Signature : Site name Address Ver 2.05 Page 1/9 C:\Program Files\INCU\DEMO205.DAT Figure B-1. Sample monitoring sheet...
  • Page 66: Figure B-2. Sample History Graph Sheet

    INCU Operators Manual Figure B-2. Sample history graph sheet...
  • Page 67: Figure B-3. Sample Parameter Numerical List

    Incubator Analyzer Report Examples Figure B-3. Sample parameter numerical list...
  • Page 68 INCU Operators Manual...
  • Page 69: Appendix C: Dat File Format

    Appendix C: DAT File Format Inside This Chapter • DAT File Format...
  • Page 70 Operators Manual The DAT File is a text file that may be imported into popular spreadsheet programs for further processing and/or analysis. The following is the format of the DAT file stored by the INCU PC Software. File *.DAT ASCII...
  • Page 71 Incubator Analyzer DAT File Format File *.DAT ASCII Incubator serial number fields (14 characters maximum) 1234 Marker 1 comment field (28 characters maximum) Marker 2 comment field (28 characters maximum) Marker 3 comment field (28 characters maximum) Marker 4 comment field (28 characters maximum) Marker 5 comment field (28 characters maximum) Marker 5 comment field (28 characters maximum) Incubator Type fields (8 characters maximum)
  • Page 72 INCU Operators Manual...

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