Operators Manual
Contents
1. Biomedical PS400 Patient Simulator Operators Manual PN 2572345 March 2006 2006 Fluke Corporation All rights reserved Printed in USA All product names are trademarks of their respective companies Warranty and Product Support Fluke Biomedical warrants this instrument against defects in materials and workmanship for one full 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 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 INNO EVENT SHALL FLUKE BIOMEDICAL BE LIABLE FOR CONSEQUENTIAL DAMAGES Only serialized products and their accessory items those products and items bearing a distinct serial number tag are covered under this one year warranty PHYSICAL DAMAGE CAUSED BY MISUSE OR PHYSICAL ABUSE IS NOT COVERED UNDER THE WARRANTY Items such as cables and non serialized modules are not covered under this warranty Recalibration of instruments is not covered under the warranty This warranty gives you specific legal rights and you may also have other rights which vary from state to state province to province or country to coun try This warranty is limited to repairing the instrument to Fluke Biomedical s specifications2. eae H Ln i aan ie if i 4 E E a Ce Se a Wp ae a EN ae RR RO RS J ehd18 bmp 19 PS400 Operators Manual RUN 5 PVC Waveform Selection Switch Position 9 Description Run of 5 PVCs and 36 normal beats repeated Pie SWE is Se Ses ae i uf an 4 V TACH Waveform Selection Switch Position 10 Description Ventricular tachycardia AV v ehd20 bmp 20 Patient Simulator Operating the Simulator V FIB Waveform Selection Switch Position 11 Description Ventricular fibrillation ehd21 bmp PACED Waveform Selection Switch Position 12 Description Paced WaT ehd22 bmp 21 PS400 Operators Manual 22 Note The simulated pacer spike preceding the ventricular response may be filtered out by the instrument under test and replaced by an internally generated marker Different instruments generate a wide range of markers to indicate that a spike has been sensed Refer to the operation service manual of the ECG equipment under test for specific information regarding the type of marker and pacer spike sensing level
3. Warranty Disclaimer Should you elect to have your instrument serviced and or calibrated by some one other than Fluke Biomedical please be advised that the original warranty covering your product becomes void when the tamper resistant Quality Seal is removed or broken without proper factory authorization We strongly recom mend therefore that you send your instrument to Fluke Biomedical for factory service and calibration especially during the original warranty period Notices All Rights Reserved Copyright 2006 Fluke Biomedical No part of this publication may be reproduced transmit ted transcribed stored in a retrieval system or translated into any language without the written permission of Fluke Biomedical Copyright Release Fluke Biomedical agrees to a limited copyright release that allows you to reproduce manuals and other printed materials for use in service training programs and other technical publications If you would like other reproductions or distributions submit a written request to Fluke Biomedical Unpacking and Inspection Follow standard receiving practices upon receipt of the instrument Check the shipping carton for damage If damage is found stop unpacking the instrument Notify the carrier and ask for an agent to be present while the instrument is unpacked There are no special unpacking instructions but be careful not to damage the instrument when unpacking it Inspect the instrument for physi cal
4. Waveform Selection Switch when the Menu Selection switch is in the Menu 2 position 15 PS400 Operators Manual AFIB Waveform Selection Switch Position 1 Description Atrial fibrillation Purpose Test the ECG monitor s ability to display a particular arrhythmia and as a training aid for health care personnel l Soe ont eae E veut Bt ehd11 bmp 2 BLK 1 Waveform Selection Switch Position 2 Description Second degree A V block type 1 Wenckebach ehd12 bmp 16 Patient Simulator Operating the Simulator RBBB Waveform Selection Switch Position 3 Description Right bundle branch block ehd13 bm PAC Waveform Selection Switch Position 4 Description Premature atrial contraction ehd14 bmp 17 PS400 Operators Manual PVC Waveform Selection Switch Position 5 Description Premature ventricular contraction early LS SS Se eS all ln I l i a naa l ehd15 bmp PVCRONT Waveform Selection Switch Position 6 Description Premature ventricular contraction R on T 65 premature 260 ms after previous normal R wave peak ehd16 bmp 18 Patient Simulator Operating the Simulator MF PVC Waveform Selection Switch Position 7 Description Multi focal premature ventricular contractions N ee PE ee E E J ehd17 bmp BIGEMINY Waveform Selection Switch Position 8 Description Normal beat followed by a PVC repeated a e m l m l
5. and in as new and re salable condition Products not returned within 90 days of purchase or products which are not in as new and resalable condition are not eligible for credit return and will be returned to the cus tomer The Return Procedure see below must be followed to assure prompt refund credit Restocking Charges Products returned within 30 days of original purchase are subject to a minimum restock ing fee of 15 Products returned in excess of 30 days after purchase but prior to 90 days are subject to a minimum restocking fee of 20 Additional charges for damage and or missing parts and accessories will be applied to all returns Return Procedure All items being returned including all warranty claim shipments must be sent freight prepaid to our factory location When you return an instrument to Fluke Biomedical we recommend using United Parcel Service Federal Express or Air Parcel Post We also recommend that you insure your shipment for its actual replacement cost Fluke Biomedical will not be responsible for lost shipments or instruments that are received in damaged condition due to improper packaging or handling Use the original carton and packaging material for shipment If they are not available we rec ommend the following guide for repackaging Use a double walled carton of sufficient strength for the weight being shipped z Use heavy paper or cardboard to protect all instrument surfaces Use no
6. damage such as bent or broken parts dents or scratches Technical Support For application support or answers to technical questions either email techservices flukebiomedical com or call 1 800 648 7952 or 1 425 446 6945 Claims Our routine method of shipment is via common carrier FOB origin Upon delivery if physical damage is found retain all packing materials in their original condition and contact the carrier immediately to file a claim If the instrument is delivered in good physical condition but does not operate within specifications or if there are any other problems not caused by shipping damage please contact Fluke Biomedical or your local sales representative Standard Terms and Conditions Refunds and Credits Please note that only serialized products and their accessory items i e products and items bearing a distinct serial number tag are eligible for partial refund and or credit Nonserialized parts and accessory items e g cables carrying cases auxiliary modules etc are not eligible for return or refund Only products returned within 90 days from the date of original purchase are eligible for refund credit In order to receive a partial refund credit of a product purchase price on a serialized product the product must not have been damaged by the customer or by the carrier chosen by the customer to return the goods and the product must be returned complete meaning with all manuals cables accessories etc
7. rejection notch filter Note Waveform example not shown because of wide range of responses possible Sine 100 Hz Waveform Selection Switch Position 6 Purpose Test high end frequency roll off diagnostic 3 dB point Note Waveform example not shown because of wide range of responses possible 12 Patient Simulator Operating the Simulator 30 BPM Waveform Selection Switch Position 7 Purpose Test ECG rate accuracy ehd6 bmp 60 BPM Waveform Selection Switch Position 8 Purpose Test ECG rate accuracy ehd7 bmp 13 PS400 Operators Manual 120 BPM Waveform Selection Switch Position 9 Purpose Test ECG rate accuracy 180 BPM Waveform Selection Switch Position 10 Purpose Test ECG rate accuracy a z z 14 ehd8 bmp ehd9 bmp Patient Simulator Operating the Simulator 240 BPM Waveform Selection Switch Position 11 Purpose Test ECG rate accuracy ehd10 bmp AUTO Waveform Selection Switch Position 12 Purpose Test monitor performance gain damping linearity and frequency response This selection is an automated sequence of six segments that run for 4 seconds each in this order a 4 second pulse sine waveforms 10 40 60 and 100 Hz and a 2 Hz triangle waveform and then the sequence repeats Note Waveform example not shown because of wide range of responses possible Menu 2 Waveforms The following waveform selections are selectable through the
8. Preparation for Use Use the 9 volt battery supplied by Fluke Biomedical or use the optional Battery Eliminator To install or replace the battery locate the Battery Compartment at the bottom of the instrument case See the illustration on the next page Press down on the arrow and slide the Battery Compartment Cover off Connect the 9 volt alkaline battery Duracell MN1604 or equivalent as illustrated in Figure 2 Make sure not to pinch the Battery Connector wires Replace the cover Note Use only alkaline batteries To check the battery set the Power Switch to BAT If the Battery LED lights the battery is good If not the battery is dead Note Refer to the Instrument Familiarity section for the location of controls and indicators Note No special cables are required for using the ECG Posts Note The High Level Output uses a 3 5 mm 2 conductor phone plug Refer to Accessories Optional in the Accessories section PS400 Operators Manual Battery Connector Case Bottom Battery Connector 4 ba Battery Battery Compartment Compartment Cover ehd2 eps Figure 2 Installing the Battery Operating the Simulator The following sections cover powering Up the Simulator and how to select the various waveforms used in testing Power Up Confirm that the battery is installed see the Preparation for Use section or that the Battery Eliminator is firmly connected to the Battery Eliminator Jack whic
9. ced between instruments intended for either monitoring or diagnostic applications For example the high end frequency response 3 dB can range from 30 Hz for a bedside monitor to over 100 Hz for a 12 lead diagnostic recorder Additionally to attenuate noise on the ECG signal during recording narrow band reject filters common to many instruments eliminate any response at the power system line frequencies of either 50 or 60 Hz Not all waveform selections are illustrated because of the wide range of responses possible Menu 1 Waveforms The following waveform selections are selectable through the Waveform Selection Switch when the Menu Selection switch is in the Menu 1 position 10 Patient Simulator Operating the Simulator SQU 2 Hz Waveform Selection Switch Position 1 Purpose Test amplitude accuracy gain damping ehd4 bmp Sine 10 Hz Waveform Selection Switch Position 2 Purpose Test bandpass response nv ehd5 bmp Sine 40 Hz Waveform Selection Switch Position 3 Purpose Test low frequency response monitor 3 dB point Note Waveform example not shown because of wide range of responses possible 11 PS400 Operators Manual Sine 50 Hz Waveform Selection Switch Position 4 Purpose Test 50 Hz rejection notch filter Note Waveform example not shown because of wide range of responses possible Sine 60 Hz Waveform Selection Switch Position 5 Purpose Test 60 Hz
10. e WaVE 00 ccccceeceeeeeteeeeeeeeeeeteeeeteee 2 Hz Rate ACCUraCy ieee eee tee eeeeeeeeeeeeeeaes 0 5 Amplitudes Lead E E E E T 0 5 1 0 1 5 2 0 mV High level output eee 0 25 0 50 0 75 amp 1 00 V Accuracy 42 2Hz square wave at 2 mV all leads Patient Simulator Accessories Accessories Standard Fluke Part Operators Manual 2572345 Battery 9 V Alkaline 614487 Battery Eliminator 90 264 Vac 9V IEC 320 C6 2183983 inlet Power Cord IEC 320 C5 connector See Note Carrying Case Vinyl 2248424 Optional Cable High Level ECG 3 5 mm phone to BNC 2200116 Calibration Manual 2577801 Note Refer to the current Fluke Biomedical Price List for availability part number and price PS400 Operators Manual Instrument Familiarity Figure identifies the controls and connectors of the Simulator High Level Menu 1 Battery Output Amplitude Power Eliminator Switch Switch Jack y i ra S HIGH LEVEL AMNEITUDE POWER BATTERY OUTPUT mv i oN Battery LED 0 5V MV LEAD OFF LEAD 1 b BAT FLUKE PS400 PATIE 2Hz 10Hz 40Hz 9 50Hz 10 60Hz 11 240 BPM 100Hz 12 AUTO ECG Posts ECG Posts AFIB 2BLK1 RBBB PAC 10 VTA PVC EARLY 11 PVCRONT 12 Menu Waveform Selector Selection Switch Switch ehd1 eps Figure 1 PS400 Controls and Indicators Patient Simulator Preparation for Use
11. e the Simulator or the equipment under test Do not proceed beyond a warning or caution until the indicated conditions are fully understood and met To ensure safe operation of the Simulator observe all instructions and warnings contained in this manual PS400 Operators Manual General Specifications Power Requirements Battery 2 00 el ea E EEEE NA 9 V Alkaline Battery Life 200 hours Line Power Battery Eliminator 115 or 230 V to 7 7 Vdc 100 mA unregulated Connector 2 5 mm center Temperature Performance Op ratihg esiisa niniin eiei 15 C to 35 C 59 F to 95 F Storage aias nara a aE e SENE 0 C to 55 C 32 F to 131 F Welght ci easpa 0 41 kg 0 9 Ib A e scsi E A concede ncuaidevinge 3 56 cm H x 13 21 cm L x 9 91 cm W 1 4 H x 5 2 L x 3 9 W Instrument Specifications Waveforms ECG waveforms 0 cccceceeseeeeeeeeteeeeeees 30 60 120 180 and 240 BPM Square wave 2 Hz SINCWAVE eniinn i dd 10 40 50 60 and 100 Hz Arrhythmias Atrial fibrillation Second degree A V block type 1 Right bundle branch block Premature atrial contraction Premature ventricular contraction early Premature ventricular contraction RonT Multifocal PVCs Bigeminy Run of 5 PVCs Ventricular tachycardia Ventricular fibrillation Paced Automated sequence Pulseira aanika eia 4 seconds Sine WAVE 000 cece cece cece ec eeeeeeeeaeeeteeeeteeaeeeeenee 10 40 60 and 100 Hz Triangl
12. es 8 List of Figures Figure Title Page 1 PS400 Controls and Indicators ccccccccccececeeeeees 2 Installing the Battery soi csivesssssssivsiersnesevessnoviveononevssinonessves 6 PS400 Patient Simulator Introduction The PS400 Patient Simulator herafter the Simulator is a high performance ECG arrhythmia simulator that generates all the waveforms necessary to check the frequency response linearity amplitude accuracy and beats per minute measurement accuracy of an electrocardiograph In addition the Simulator generates arrhythmias The Simulator has a complete 12 lead output and a single high level output The Simulator is for biomedical equipment technicians or service representatives to test the basic operation of physiological monitoring and diagnostic equipment These tests are typically conducted during routine or scheduled preventive maintenance inspections This instrument can also verify calibration to the precision stated in Simulator Instrument Specifications For the recommended inspection protocol and the required level of precision refer to the calibration manual for the actual equipment under test The Simulator is not intended to be used as the primary signal source for the initial validation of patient related equipment Safety Information In this manual a A A Warning identifies conditions and actions that pose hazards to the user A A Caution identifues conditions and actions that may damag
13. h is located on the top of the instrument Note For locations of PS400 controls and indicators see the Instrument Familiarity section The Power Switch has three positions ON OFF and BAT To power up the Simulator push the Power Switch to the ON position Note The Simulator does not have a continuous power on indicator extending battery life Turn the instrument off when not using it To check the battery s status hold the Power Switch in the BAT position The Battery LED illuminates if the battery is good If the Battery LED does not light replace the battery Patient Simulator Operating the Simulator If the battery is low but not dead the Simulator output waveform is a sawtooth such as illustrated below regardless of the waveform selected Amplitude of the sawtooth waveform varies depending on how low the battery is A hace Sek RT gt Tar OO RR Ta alt Te E 1 AEA HY SS ee a r i a all ehd3 bmp Selection Waveforms The Simulator is able to produce 24 different waveforms To select a waveform select one of the two menus using the Menu Selector Switch and turn the 12 position rotary Waveform Selector Switch to the number that corresponds to the desired waveform The waveforms are available on both the ECG Posts and the High Level Output PS400 Operators Manual Menu 1 Selections Setting the Menu Selector Switch to the upper position enables the following selecti
14. nabrasive material around all projecting parts Use at least four inches of tightly packed industry approved shock absorbent material around the instrument Returns for partial refund credit Every product returned for refund credit must be accompanied by a Return Material Authoriza tion RMA number obtained from our Order Entry Group at 1 800 648 7952 or 1 425 446 6945 Repair and calibration To find the nearest service center goto www flukebiomedical com service or In the U S A Cleveland Calibration Lab Tel 1 800 850 4606 Email globalcal flukebiomedical com Everett Calibration Lab Tel 1 888 99 FLUKE 1 888 993 5853 Email service status fluke com In Europe Middle East and Africa Eindhoven Calibration Lab Tel 3 1 402 675300 Email ServiceDesk fluke com In Asia Everett Calibration Lab Tel 425 446 6945 Email service international fluke com Certification This instrument was thoroughly tested and inspected It was found to meet Fluke Biomedical s manufacturing specifications when it was shipped from the factory Calibration measurements are traceable to the National Institute of Standards and Technology NIST Devices for which there are no NIST calibration standards are measured against in house performance standards us ing accepted test procedures WARNING Unauthorized user modifications or application beyond the published specifications may result in electrical shock hazards or imp
15. ons from Menu 1 as described in Table 1 Table 1 Menu 1 Selections Swen poston Simulation 12 Auto Automated sequence each segment runs for 4 seconds in this order a 4 second pulse sine waves 10 40 60 and 100 Hz and a 2 Hz triangle wavefrom Patient Simulator Operating the Simulator Menu 2 Selections Setting the Menu Selection switch to the lower position enables the following selections from Menu 2 as described in Table 2 Table 2 Menu 2 Selections C swich Poston smuain AFIB Atrial Fibrillation 2 BLK 1 Second degree A V block type 1 Wenckebach Right bundle branch block PVC Premature ventricular contraction early PVCRONT Premature ventricular contraction R on T Amplitude Selection Use the 4 position Amplitude Switch to make the following selections on Lead I 0 5 mV 1 0 mV 1 5 mV 2 0 mV Waveform Examples The Simulator waveform selections and their purposes are listed in this section The waveform examples illustrated were plotted using an ECG strip chart recorder set at 1 mV cm sensitivity and 25 mm s chart speed in the Lead I PS400 Operators Manual configuration The frequency response was set in the monitoring quality mode 3 dB 30 Hz Because of inherent differences in frequency response signal acquisition and filtering techniques the responses of the ECG equipment under test may vary from the waveforms illustrated The major differences are noti
16. roper operation Fluke Biomedical will not be responsible for any injuries sustained due to unauthorized equipment modifications 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 incorpo rated in new editions of the publication No responsibility is assumed by Fluke Biomedi cal for the use or reliability of software or equipment that is not supplied by Fluke Bio medical or by its affiliated dealers Manufacturing Location The PS400 Patient Simulator is manufactured in Everett WA U S A Table of Contents Titrod tton nesies aap sacecesterca ascend ees a agence entities ends Safety Information cic scsscesscescasecssetecoudsseacesnesabieedia is sacgeodecuaiedsaseugnetsibess General Specifications Instrument Specifications ACCESS e E E N S E E S S Instrument Familiarity Preparation for USS sssi isssisiesseseeds cseisscetoczenescae cause siete Operating the Simulator Powet UP ecceeeeeenees Selection Waveforms Menu 1 Selections 04 Menu 2 Selections Amplitude Selection Waveform Examples Menu 1 Waveforms Menu 2 Waveforms List of Tables Table Title Page 1 Menu 1 Selections ccccccccceccceessssecescceceessssseseeseeseeeees 2 Menu 2 Selections cccccceccecsessceccecesessescesceessesceaceaee
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