Fluke Biomedical IDA-4 Plus Operator's Manual
Fluke Biomedical IDA-4 Plus Operator's Manual

Fluke Biomedical IDA-4 Plus Operator's Manual

Infusion pump analyzer
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Operators
Manual
IDA-4 Plus
Infusion Pump
Analyzer

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Summary of Contents for Fluke Biomedical IDA-4 Plus

  • Page 1 Operators Manual IDA-4 Plus Infusion Pump Analyzer...
  • Page 3 IDA-4 Plus Infusion Pump Analyzer Operators Manual April 2005  2005 Fluke Corporation. All rights reserved. Printed in USA All product names are trademarks of their respective companies.
  • Page 4 IDA-4 Plus Operators Manual...
  • Page 5: Table Of Contents

    Infusion Pump Analyzer Contents Contents Contents................................iii Notices................................. vii Customer Service and Sales ..........................vii All Rights Reserved............................. vii Restrictions and Liabilities ..........................vii Claims.................................. vii Warnings ................................viii Patient Circuit..............................viii Contamination of the Measuring System ......................viii Explosion Risk ..............................viii Switching the Instrument ON or OFF ........................
  • Page 6 IDA-4 Plus Operators Manual 3 Operating Instructions Connecting Infusion Pumps under Test......................3-1 See Inlet Hose Connections and Outlet Hose Connections drawings..............3-1 Inlet Hose Connections Drawing........................3-2 Outlet Hose Connections Drawing ........................3-3 General Operating Notes ............................ 3-4 First Time Use ..............................
  • Page 7 Infusion Pump Analyzer Contents Suggested Apparatus for Back Pressure Testing Drawing ................3-36 4 Maintenance, Service and Calibration User Care and Maintenance..........................4-1 Storage................................4-1 Handling ................................4-1 Use..................................4-1 Care of the Instrument Case ..........................4-1 Cleaning the Inside of the Instrument......................... 4-1 User Performance Check............................
  • Page 8 IDA-4 Plus Operators Manual...
  • Page 9: Notices

    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.
  • Page 10: Warnings

    2. Pack the instrument carefully, using the original packing materials if available. Failure to pack the instrument properly could void your warranty and result in you paying for the instrument’s repair. 3. Insure the unit for full retail value and ship to the address specified by Fluke Warnings Patient Circuit This instrument has been designed for testing infusion devices but must NEVER be used while connected to a patient.
  • Page 11: Storage And Shipping

    Disconnecting the keyboard and reconnecting usually restores normal keyboard function. It is recommended a CE marked keyboard is used. Trademarks All trademarks mentioned in this document are acknowledged. Manufacturing for: Fluke Biomedical 6920 Seaway Blvd Everett, WA 98203 USA 775-883-3400 800-648-7952...
  • Page 12: Warranty

    Fluke Biomedical. This warranty does not apply if the product has been damaged by accident or misuse or as the result of service or modification by other than Fluke Biomedical. IN NO EVENT SHALL FLUKE BIOMEDICAL BE LIABLE FOR CONSEQUENTIAL DAMAGES.
  • Page 13: Introduction

    Chapter 1 Introduction This chapter introduces the instrument and describes its features. Thank you Thank you for purchasing this instrument. It will allow you to verify the operation of your infusion devices providing measurements of volume delivered, flow rate and occlusion and backpressure.
  • Page 14: Features

    IDA-4 Plus Operators Manual Features Tests up to four Infusion Devices simultaneously (when four measuring Transducers fitted) Five button keypad operation Measurement of Volume Delivered Measurement of Flow Rate Measurement of Occlusion Pressure Measurement of Back Pressure Menu driven Utilities settings LCD (liquid crystal display) super twist Graphics with back light Package Contents The contents of this package as shipped include:...
  • Page 15: Specifications

    Infusion Pump Analyzer Introduction Specifications Electrical Specification: Supply Voltage 90 - 260 VAC. Supply Frequency 50 - 60 Hz. Supply Power < 30 VA. Fuse 20 mm 250 V, 1 A (T) (slow blow). Earth Leakage Current < 1.0 mA in single fault condition. Flow Rate Measurement Technique: Flow is calculated by measuring a volume over time.
  • Page 16: Physical

    IDA-4 Plus Operators Manual Physical Dimensions: ~19.05 cm x 18.11 cm x 30.18 (L x W x H) (for rear panel handle add 3.81cm) Weight: 5.0 Kg (with 4 transducer fitted) Case: Molded plastic front panel, metal rear housing. Color: RAL 9002 Environmental Operational: 15-30 C up to 50% Relative Humidity...
  • Page 17: An Overview

    PC via an RS232 port. The unit may also be linked to, controlled by and display results via a PC using an external program, such as HydroGraph™ available from Fluke Biomedical. Volume & Flow Measurement Volume and flow measurements are achieved by using a calibrated burette and opto- sensors within each measurement transducer to accurately monitor the volume and time of the meniscus passing up the burette.
  • Page 18: Front Panel Description

    IDA-4 Plus Operators Manual Front Panel Description Liquid Crystal Display-240 dot (W) x 128 (H). Graphic and Alphanumeric. With backlight. Up, Down, Right and Left key-pad switches Enter keypad. Power ‘ON’ Indicator Channel 1 Fluid ‘IN’ connector. Channel 2 Fluid ‘IN’ connector. Channel 3 Fluid ‘IN’...
  • Page 19: Front Panel Layout Drawing

    Infusion Pump Analyzer An Overview Front Panel Layout Drawing inlets channel 1 channel 2 channel 3 channel 4...
  • Page 20: Rear Panel Description

    IDA-4 Plus Operators Manual Rear Panel Description Mains ON / OFF switch. Three pin IEC mains inlet connection. Twin fuses integral with mains connector. Alarm Control port. 15 way. (for optional trigger interface). Parallel Printer Port. 25 way Female. Configured in the same way as a PC Printer Port. Bar Code Wand Port.
  • Page 21: Rear Panel Layout Drawing

    Infusion Pump Analyzer An Overview Rear Panel Layout Drawing...
  • Page 22: Ida-4 Plus Operators Manual

    IDA-4 Plus Operators Manual...
  • Page 23: Operating Instructions

    Chapter 3 Operating Instructions This chapter discusses and illustrates the method of connecting units under test and the various operational modes. Connecting Infusion Pumps under Test See Inlet Hose Connections and Outlet Hose Connections drawings. The Inlet Hose Connection drawing on the next page shows a method of connecting the inlets from units under test together with a priming syringe, both connected via a 3-way tap.
  • Page 24: Inlet Hose Connections Drawing

    IDA-4 Plus Operators Manual Inlet Hose Connections Drawing...
  • Page 25: Outlet Hose Connections Drawing

    Infusion Pump Analyzer Operating Instructions Outlet Hose Connections Drawing USE ONLY 250V FUSES DRAINAGE TUBES TO FLUID COLLECTION VESSEL...
  • Page 26: General Operating Notes

    IDA-4 Plus Operators Manual General Operating Notes The IDA-4 Plus is operated by four directional arrow buttons and an ENTER button on the front panel. These are used to operate a sequence of menus. An optional external keyboard can also be used to control the instrument and enter data. Any time data is prompted for, the bar code port is activated.
  • Page 27: Warning Of Contamination

    Infusion Pump Analyzer Operating Instructions MICRO-90 is available from: International Product Corp. 201 Connecticut Dr. P.O. Box 70 Burlington, NJ 08016-0070 USA Tel 609 386 8770 also International Product Corp. 1 Church Row Chistlehurst, Kent BR7 5PG United Kingdom Tel. 0208 467 8944 Warning of Contamination Care should also be taken to prevent dirt, dust, metal swarf, or other debris from entering the measuring system since these are likely damage the transducers.
  • Page 28: Start-Up Screen

    IDA-4 Plus Operators Manual Start-up Screen When the unit starts, an introductory screen containing FLUKE the name of the instrument, time, date and firmware version is displayed. After performing initialization BIOMEDICAL procedures and self tests the instrument advances to the STATUS ALL CHANNELS screen.
  • Page 29: Utilities

    Infusion Pump Analyzer Operating Instructions Utilities This screen is displayed whenever UTIL is selected. U T I L I T I E S Using the arrow keys to move the cursor to the required utility, in this case RECALL TESTS is selected, press ENTER and the set-up screen for the chosen utility is RECALL TESTS REPORT HEADER...
  • Page 30: Lcd Set-Up

    IDA-4 Plus Operators Manual LCD Set-up Cursor defaults to MODE when this screen is selected, L C D S E T U P pressing ENTER changes the screen mode to black on M O D E white or white on black. Choosing ESC and pressing ENTER accepts the mode and contrast as displayed and returns the screen to STATUS ALL CHANN...
  • Page 31: Report Header

    Infusion Pump Analyzer Operating Instructions Report Header The REPORT HEADER of three lines and up to 28 U t i l i t y R e p o r t H e a d e r characters on each line is entered via this screen. The ………………………………………………………………..
  • Page 32: Engineering Tests

    IDA-4 Plus Operators Manual Engineering Tests Using the arrow keys, move the cursor to the required E N G I N E E R I N G T E S T S selection and press ENTER. T e s t P r i n t e r Test Printer Checks the link to the printer by sending the serial P r i n t S e t t i n g s...
  • Page 33: Channel Set-Up Menu

    Infusion Pump Analyzer Operating Instructions Channel Set-up Menu This screen allows the operator to select the type of test C H A N N E L S E T U P to be performed as a rapid test or elect to enter further details before selecting the type of test.
  • Page 34: Device Information

    IDA-4 Plus Operators Manual Device Information This screen prompts the operator for device and test D e v i c e I n f o r m a t i o n C h a n information for the specific device under test. Data may Control No be entered into the fields on this screen from the Operator...
  • Page 35: Sub Menu1

    Infusion Pump Analyzer Operating Instructions Sub Menu1 This menu is reached when all the mandatory fields D e v i c e I n f o r m a t i o n C h a n have been entered. From this point is possible to go Control No 12345 directly to a test or request further information.
  • Page 36: Sub Menu2

    IDA-4 Plus Operators Manual Location This is an optional field of sixteen characters in length. It is used to store the normal location of the device under test. Pressing ENTER from this field advances to the SUB MENU 2. ESC goes back to the Serial Number field Sub Menu2 This menu allows you to select the type of test to D e v i c e...
  • Page 37: Flow Test Screen (Prime Mode)

    Infusion Pump Analyzer Operating Instructions Flow Test Screen (Prime Mode) This is the screen that allows the operator to control the CHANNEL 1 FLOW flow test. It has a menu across the bottom of the screen FLOW 0.00 that changes to reflect the progress of the active test. ml /h VOLUME 0.00...
  • Page 38: Flow Test Screen (Measuring Mode)

    IDA-4 Plus Operators Manual Flow Test Screen (Measuring Mode) When the flow test is started the screen is advanced to CHANNEL 1 FLOW the measuring mode as shown. This enables more menu FLOW 0.00 options. ml /h VOLUME 0.00 Status ELAPSED TIME 00: 00: 00 This invokes the STATUS ALL CHANNELS screen.
  • Page 39: Flow Test Screen (End Of Test Mode)

    Infusion Pump Analyzer Operating Instructions Flow Test Screen (End of Test Mode) This view of the FLOW TEST screen allows the CHANNEL 1 operator to save, print or delete the results of the test. Save FLOW 0.00 ml /h This saves the results of the flow test, or series of tests, to non-volatile memory for later printing or transfer to a VOLUME 0.00...
  • Page 40: Flow Graph Screen

    IDA-4 Plus Operators Manual Flow Graph Screen The FLOW GRAPH screen shown displays the C H A N N E L 1 F L O W G R A P H average flow rate as a continuous line and instantaneous A v g flow rate as a dashed line.
  • Page 41: Occlusion Test Screen

    Infusion Pump Analyzer Operating Instructions Occlusion Test Screen This is the screen that allows the operator to control the occlusion test. It has a menu across the bottom of the screen that changes to reflect the progress of the test. It is not necessary to prime the transducer to perform an occlusion test.
  • Page 42: Occlusion Test Screen (Start Mode)

    IDA-4 Plus Operators Manual Occlusion Test Screen (Start Mode) When the transducer has completed its tare operation C H A N N E L 1 O C C L U S I O N the screen changes as shown. PRESSURE 0.00 Start When the transducer has completed its tare...
  • Page 43: Occlusion Test Screen (End Of Test Mode)

    Infusion Pump Analyzer Operating Instructions Occlusion Test Screen (End of Test Mode) This view of the OCCLUSION TEST screen allows C H A N N E L 1 O C C L U S I O N the operator to save, print or delete the results of the occlusion test.
  • Page 44: Occlusion Graph Screen

    IDA-4 Plus Operators Manual Occlusion Graph Screen This graph displays the pressure value over time. It C H A N N E L 1 O C C L U S I O N automatically adjusts its scale so that its maximum pressure and time are always within the axes.
  • Page 45: Pca Test Information Screen

    Infusion Pump Analyzer Operating Instructions PCA Test Information Screen This screen is displayed whenever the operator elects to C h a n P C A T e s t I n f o r m a t i o n perform a PCA TEST.
  • Page 46: Pca Test Screen

    IDA-4 Plus Operators Manual bolus will be reported as a loading dose, otherwise a loading dose will not be reported. On completion of this field, the PCA TEST screen is invoked. Note: When testing PCA pump performance it is essential that new syringes be used. It has been observed that syringe performance degrades rapidly after about 10 uses.
  • Page 47: Pca Test Screen (Start Mode)

    Infusion Pump Analyzer Operating Instructions PCA Test Screen (Start Mode) When the measuring circuit is primed successfully the C h a n n e l 1 P C A screen changes as shown. L a s t B o l u s A v e r a g e Auto-Start 0 .
  • Page 48: Pca Test Screen (End Of Test Mode)

    IDA-4 Plus Operators Manual PCA Test Screen (End of Test Mode) This view of the FLOW TEST screen allows the C h a n n e l 1 P C A operator to save, print or discard the results. L a s t B o l u s A v e r a g e Save 0 .
  • Page 49: Pca Graph Screen

    Infusion Pump Analyzer Operating Instructions PCA Graph Screen The PCA GRAPH screen displays the available data in C h a n n e l 1 P C A G R A P H a bar graph format. The amplitude of each spike represents the flow rate at which each bolus is V o l 3 .
  • Page 50: Optional Pca Trigger / Remote Call Interface

    IDA-4 Plus Operators Manual PCA Activity with Basal Flow This will follow the PCA Activity Only scenario described above, but with a basal flow rate set. The basal flow rate should also be entered on the IDA-4 Plus. Basal Flow Only When a PCA pump is operated with the basal flow rate only, it should be tested using the normal single flow rate method.
  • Page 51 Infusion Pump Analyzer Operating Instructions Remote Call Input Any change in the Remote Call Input jacks (one for remote call input configuration each channel) will be detected by the IDA-4 Plus. For voltage output remote call, connect the higher potential to interface box 1/4”...
  • Page 52: Dual Rate Test Information Screen

    IDA-4 Plus Operators Manual Dual Rate Test Information Screen This screen prompts the operator for information D U A L R A T E T E S T I N F O R M A T I O N required to perform a dual rate flow test. As a minimum requirement the primary flow rate will be needed.
  • Page 53: Dual Rate Test Screen

    Infusion Pump Analyzer Operating Instructions Dual Rate Test Screen This is the screen that allows the operator to control the dual rate flow test. It has a menu across the bottom of the screen that changes to reflect the progress of the test.
  • Page 54: Dual Rate Test Screen (Measuring Mode)

    IDA-4 Plus Operators Manual Dual Rate Test Screen (Measuring Mode) When the test is started, the screen enters measuring C H A N N E L 1 D U A L F L O W mode for the primary flow rate (Flow 1) as shown. This FLOW 1 0.00 enables further menu options.
  • Page 55: Dual Rate Test Screen (End Of Test Mode)

    Infusion Pump Analyzer Operating Instructions Dual Rate Test Screen (End of Test Mode) This view of the DUAL FLOW TEST screen allows C H A N N E L 1 D U A L F L O W the operator to save, print or discard the results. FLOW 1 0.
  • Page 56: Dual Rate Graph Screen

    IDA-4 Plus Operators Manual Dual Rate Graph Screen The DUAL FLOW RATE screen displays the average flow rate for the primary and for the secondary flows. C H A N N E L 1 D U A L F L O W Deviation marks as described in the single flow rate Primary graph are shown for the primary flow rate only.
  • Page 57: Measuring Flow-Rate Against Back-Pressure

    Infusion Pump Analyzer Operating Instructions Measuring Flow-rate against Back-pressure Safety and performance standards for infusion devices expect manufacturers to state the flow characteristics under specified backpressure conditions. For instance, the flow rate might be quoted at zero output pressure, then subjected to backpressure of +300mmHg, and then -100mmHg.
  • Page 58: Suggested Apparatus For Back Pressure Testing Drawing

    IDA-4 Plus Operators Manual Suggested Apparatus for Back Pressure Testing Drawing 3 - WAY TAP inlets FROM OUTLET CONNECTOR channel 1 channel 2 channel 3 channel 4 BULB TO PRESSURIZE BOTTLE PRESSURE METER (GAUGE) FLUID IN FROM INFUSION DEVICE 1 OR 2 LITER BOTTLE (e.g.
  • Page 59: Maintenance, Service And Calibration

    Chapter 4 Maintenance, Service and Calibration This chapter discusses routine maintenance and calibration procedures for the user. User Care and Maintenance Storage Do not leave water inside the unit when storing or shipping. At the factory units are ‘dried’ before shipping by connecting a suction pump to each of connectors in turn for 2 minutes.
  • Page 60: User Performance Check

    IDA-4 Plus Operators Manual User Performance Check The Calibration is set at the factory. For accurate Re-Calibration or resetting of Calibration the unit must be returned via the dealer. Users may wish to check for faults after a period of use or after shock to the unit.
  • Page 61: A Infusion Devices Delivery Methods

    Appendix A Infusion Devices Delivery Methods This Appendix gives an overview of and discusses different types of Infusion Devices and Delivery Methods Infusion Devices: An Overview Infusion devices may be grouped into two types, gravity controllers and infusion pumps. Gravity Controllers are powered devices which control the flow of the infusion to the desired rate by constricting the infusion line.
  • Page 62: Patient Controlled Analgesia (Pca) Pumps

    IDA-4 Plus Operators Manual Patient Controlled Analgesia (PCA) Pumps These are devices in which the patient is able to initiate a dose of the infusion solution for the relief of pain. Access by the patient to the pump itself is prevented, pre-programmed restraints are placed on the parameters of the boluses and, in addition, a basal rate delivery of solution outside the control of the patient may be provided.
  • Page 63: Drip-Rate Controllers

    Infusion Pump Analyzer Infusion Devices Delivery Methods Control against over-infusion is effective, but increased resistance to flow may result in under-infusion. The better controllers incorporate a flow status system in which users are provided with a visual indication of increased resistance to flow, which could mean that there is a ‘positional IV’...
  • Page 64: Infusion Pumps

    IDA-4 Plus Operators Manual Infusion Pumps General Common to all pumps is the ability to overcome resistance to flow by increased deliver pressure. Pumps do not rely on gravity and can therefore be placed in almost any reasonable position relative to the infusion site (but not too high). The delivery pressure may rise to high values in some devices in the event of a catheter becoming occluded or displaced, with the danger of extra-vascular infusion.
  • Page 65: Syringe Pumps

    Infusion Pump Analyzer Infusion Devices Delivery Methods automatic alarm and shut down if air enters the system; pre-set control of total volume to be infused with digital readout of volume infused; automatic switching to keep vein open (KVO) rate at the end of the infusion; comprehensive alarm systems; automatic switch over to internal battery operation on failure of mains supply, with the facility to use the device on internal battery power only, if no mains power is available (for example during transportation);...
  • Page 66: Pumps For Ambulatory Use

    IDA-4 Plus Operators Manual A feature of most PCA pumps is a memory log, which can be accessed either through the display, or downloaded via a printer or computer. This enables the clinician to determine when and how often, a demand has been made by the patient and what total volume of drug has been infused over a given time.
  • Page 67 Infusion Pump Analyzer Infusion Devices Delivery Methods being infused; built-in drug libraries; interface for computer control and monitoring. If these facilities are software enabled, by programming or smart card for example, in a pump that is otherwise suitable for other applications, they must be disabled before these pumps are used in any other application.
  • Page 68 IDA-4 Plus Operators Manual...
  • Page 69: B Computer Control Commands

    Power off the IDA-4. Connect the provided serial communications null modem cable or Fluke Biomedical’s serial cable (PN 2392046) between the IDA-4 Plus serial port and the computer. Make a note as to which PC communications port the cable is connected to.
  • Page 70: Controlling The Ida-4 Plus Using Serial Protocol

    IDA-4 Plus Operators Manual Controlling the IDA-4 Plus Using Serial Protocol The IDA-4 Plus allows the operator full flexibility with regard to the RS232 port. Capabilities include receiving and sending data at baud rates of 300, 600, 1200, 2400, 4800, 9600, 19200 and 38400. The baud rate used for transmission is held in the IDA-4 Plus non-volatile memory and can be changed at any time by the operator.
  • Page 71: Perform A Volume Test [Cnv,A,B,C]

    Infusion Pump Analyzer Computer Control Commands Perform a Volume Test [CnV,a,b,c] This command starts a flow / volume test on the specified channel. The IDA-4 Plus status all channels screen will prompt the operator to prime the channel. Once primed, the operator will have to press the Start key on the IDA-4 Plus front panel or send the [CnV] command again.
  • Page 72: Perform A Dual Flow Rate Test [Cnd,A,B,C,D,E,F]

    IDA-4 Plus Operators Manual Perform a Dual Flow Rate Test [CnD,a,b,c,d,e,f] This command starts a Dual Flow rate test on the specified channel. The IDA-4 Plus status all channels screen will prompt the operator to prime the channel and start the test. Once primed, the operator can press the start key on the front panel or send the [CnD] command again.
  • Page 73: Fetch The Current Pressure On A Channel [Presn]

    Infusion Pump Analyzer Computer Control Commands Fetch the Current Pressure on a Channel [PRESn] Returned to host: [PRES, pppp,hh:mm:ss:mmm] <CR><LF> Where: pppp is the pressure in the selected units hh:mm:ss:mmm is the time since the start of the test, formatted as: Hours mmMinutes Seconds...
  • Page 74 IDA-4 Plus Operators Manual ASCII Code Function Number of IDA-4 Plus Parameters < - - > Terminates - - > Computer Control POLL Returns # of < - - > channels installed PRESUn Sets the pressure n = Channel number - - >...

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