DataSim Operators Manual. Patient Simulator

Transcription

1 DataSim 6100 Patient Simulator Operators Manual PN February Fluke Corporation, All rights reserved. Printed in USA. Specifications subject to change without notice. All product names are trademarks of their respective companies.

2 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, IN- DIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES OR LOSSES, INCLUDING LOSS OF DATA, ARISING FROM ANY CAUSE OR THE- ORY. 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. 07/07

3 Notices All Rights Reserved Copyright 2008, 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. 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 physical damage such as bent or broken parts, dents, or scratches. Technical Support For application support or answers to technical questions, either techservices@flukebiomedical.com or call or 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.) and in as new and resalable 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 customer. 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 restocking 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.

4 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 recommend the following guide for repackaging: Use a double-walled carton of sufficient strength for the weight being shipped. Use heavy paper or cardboard to protect all instrument surfaces. Use nonabrasive 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 Authorization (RMA) number, obtained from our Order Entry Group at or Repair and calibration: To find the nearest service center, go to or In the U.S.A.: Cleveland Calibration Lab Tel: globalcal@flukebiomedical.com Everett Calibration Lab Tel: service.status@fluke.com In Europe, Middle East, and Africa: Eindhoven Calibration Lab Tel: ServiceDesk@fluke.com In Asia: Everett Calibration Lab Tel: 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 using accepted test procedures. WARNING Unauthorized user modifications or application beyond the published specifications may result in electrical shock hazards or improper operation. Fluke Biomedical will not be responsible for any injuries sustained due to unauthorized equipment modifications.

5 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 by its affiliated dealers. Manufacturing Location The DataSim 6100 Patient Simulator is manufactured in Everett, Washington by Fluke Biomedical, 6920 Seaway Blvd., Everett, WA, U.S.A.

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7 Table of Contents Chapter Title Page 1 Introduction and Specifications Introduction Features General Safety Considerations Symbols Warnings and Cautions Instrument Familiarity Front Panel Pendant Keypad Controller Direct Functions Special Functions PAC and PVC Insertion Modifier/Cal Mode Specifications Accessories Operation Introduction Size Adjustments Calibration Heart Rate Adjustment Artifact Simulation Respiration Defibrillation Training Blood Pressure Simulation Personality Modules (Optional Special Functions) Interactive IABP Personality Modules Cardiac Output Personality Modules Blood Pressure Cables Connector Interface Pin Definitions Maintenance, Service, and Calibration Maintenance Avoiding Damage Cleaning i

8 DataSim 6100 Operators Manual Battery Charging and Replacement Service and Calibration ii

9 List of Tables Table Title Page 1-1. Symbols Simulator Front Panel Controls and Indicators Lead ECG Amplitude Pendant Keypad Controls and Indicators Pendant Keypad Codes and Functions Functions Used in the Modifier/Cal Mode Standard Accessories Optional Accessories (Series 90) Blood Pressure Cables Waveform Amplitudes Effects of Size Adjustments on Parameters Calibration Functions Heart Rates Obtained via Rate Adjust Special Function Artifact Modifier Effects Personality Modules Appropriate Pressure Simulator Interface Cables ECG Connectors Pressure Connectors iii

10 DataSim 6100 Operators Manual iv

11 List of Figures Figure Title Page 1-1. Simulator Front Panel Controls and Indicators Pendant Keypad Controls and Indicators Pressure Cable Wiring for Monitor with 5 µv/v mmhg Sensitivity Pressure Cable Wiring for Monitor with 40 µv/v mmhg Sensitivity Connector Pin Assignments v

12 DataSim 6100 Operators Manual vi

13 Chapter 1 Introduction and Specifications Contents Page Introduction Features General Safety Considerations Symbols Warnings and Cautions Instrument Familiarity Front Panel Pendant Keypad Controller Direct Functions Special Functions PAC and PVC Insertion Modifier/Cal Mode Specifications Accessories

14 DataSim 6100 Operators Manual 1-2

15 Introduction and Specifications Introduction 1 Introduction The DataSim 6100 Patient Simulator, hereafter referred to as the Simulator, is a battery-operated, six-channel patient simulator and defibrillation trainer. Critical care nurses, ACLS program instructors, and other clinical educators can generate an extensive range of simulations, from a simple normal sinus rhythm to a complex Swan-Ganz catheter insertion, as well as a wide range of real world ECG, pressure, and respiration artifacts. In the standard defibrillation training mode, the instructor can interface the Simulator with patient manikins and teach students the correct way to defibrillate a patient, plus the desired effect on ECG and BP activity. All control keys and display prompts are on a hand-held pendant keypad connected to the unit with a flexible, 20-foot, coiled telephone-style cord that gives a wide range of motion. Standard waveforms and sequences, selected via the keypad, are stored in microcomputer memory within the Simulator. A variety of optional Personality Modules expands the number of available waveform selections and sequences and includes functions for special purpose ECG, Cardiac Output Dilution Curves, Capnography, and IABP. Each personality module plugs into the Simulator front panel. A video adapter allows display of generated ECG and BP waveforms on any standard TV set. The enlarged format increases visibility and comfort level for a class of students. Features The Simulator has the following features: Training capabilities Six channels for generating ECG, arrhythmias, blood pressure, and respiration Synchronization of hemodynamic waveforms Manual PAC and PVC insertions Swan-Ganz procedure Interface with Resusci-Anne, Arrhythmia Anne, and Chris Clean manikins Optional Personality Modules Video adapter interface 1-3

16 DataSim 6100 Operators Manual General Safety Considerations Read the Users Manual before operating the Analyzer. Note If calibration or other service of the Simulator is required, only qualified service personnel should be permitted to remove the front panel of the Simulator. Symbols Table 1-1 describes the symbols associated with the Analyzer. Table 1-1. Symbols Symbol X W P ~ Hazardous voltage Description Important information; refer to manual. Conforms to European Union directives Do not dispose of this product as unsorted municipal waste. Go to Fluke s website for recycling information. Warnings and Cautions A Warning identifies hazardous conditions and actions that could cause bodily harm or death. A Caution identifies conditions and actions that could damage the Analyzer, the equipment under test, or cause permanent loss of data. Levels of signals available via the output connectors and the Personality Module connector do not exceed 12 volts, and as such, do not constitute a potential danger to the operator. However, observe the following: 1-4

17 Introduction and Specifications Instrument Familiarity 1 XW Warning To avoid possible electrical shock or personal injury, follow these guidelines: Use this Simulator only in the manner specified by the manufacturer or the protection provided may be impaired. Read the Users Manual before operating the Simulator. Do not connect the Simulator to a patient or equipment connected to a patient. The Simulator is intended for equipment evaluation only and should never be used in diagnostics, treatment or in any other capacity where the Simulator would come in contact with a patient Instrument Familiarity The functions of the Simulator are controlled from the front panel and the pendant keypad. Front Panel Figure 1-1 shows the front panel controls and indicators of the Simulator. Table 1-2 lists these components with accompanying descriptions. 1-5

18 DataSim 6100 Operators Manual 1 2 DataSim 6100 Patient Simulator LL (+) 3 LA (-) On NSR TACH BRAD ASYS Off POWER RA (-) 0 A-FLTR 1 A-FIB 2 2AVB1 3 2AVB2 ECG RL 4 3AVB 8 5 PAC 9 6 PVC1 7 PVC2 ART V1 10 CPLT V-TAC V-FIB SPEC STD FUNC PA V2 KEYPAD RA V3 V PERSONALITY MODULE AUX MANKIN V5 V6 SIMULATE DEFIB Figure 1-1. Simulator Front Panel Controls and Indicators fdg001.eps 1-6

19 Introduction and Specifications Instrument Familiarity 1 Table 1-2. Simulator Front Panel Controls and Indicators Label Component Description A Power Indicator Illuminates when power is ON B Power Switch Switches power on and off C D ECG Snap Connectors Pressure Output Connectors This battery operated unit is rechargeable with the supplied charger. Outputs low level 12 lead ECG Attach standard patient ECG cable lead wires to these snap connectors to display the simulated ECG waveforms on the monitor screen. To minimize 60-cycle artifact, use a reference electrode connection. For example, most five-lead ECG diagnostic recorders require that a Simulator REF signal is connected to the RL input of the patient cable. The Simulator can also output the ECG in a modified chest lead configuration (MCL2) used for bedside monitoring. Simply attach the LL (+) red, RA (-) white, and LA (ref) patient cable snaps to the patient Simulator. Refer to the operators manual of the ECG monitor for hook-up instructions. Output for arterial, PA, and RA pressures This output simulates the electrical output of the BP transducer that would be used with the patient monitor. The Simulator generates signals that are compatible with either 5 or 40-microvolt transducers. 1-7

20 DataSim 6100 Operators Manual Table 1-2. Simulator Front Panel Controls and Indicators (cont.) Label Component Description E Aux Input/Output Connector Cable interconnects for optional waveform, such as capnography and IABP F Manual Defib Switch Manually simulates defibrillation G Defib Connector Input for Arrhythmia Anne or Chris Clean manikins equipped with defibrillation option H Personality Module Connector Input for optional modules Used to add numerous functions and waveforms to the standard set I Keypad Connector Input for hand-help keypad J Keypad Rest Storage area for the keypad Inner Well Back Battery Charger Input Connector Jack used to recharge battery The unit can be operated while recharging. Table 1-3. Lead ECG Amplitude Lead # ECG Amplitude I +.25 mv (+/- 5%) II +1.0 III +.75 AVR.60 AVL -.25 AVF +.90 V1.40 V2.90 V V V V

21 Pendant Keypad Controller Introduction and Specifications Instrument Familiarity 1 The pendant keypad controller has two general classes of functions, direct and special, that are accessed by pressing individual keys or combinations of keys. The following pages describe functions and codes available in the standard Simulator unit. Figure 1-2 shows the keypad controls and indicators, and Table 1-4 lists and describes these components. DataSim 6100 Patient Simulator 1 2 NSR TACH BRAD ASYS A-FLTR 4 A-FIB 5 2AVB1 6 2AVB AVB PAC 8 9 PVC1 PVC2 3 CPLT V-TAC V-FIB SPEC STD FUNC 5 Figure 1-2. Pendant Keypad Controls and Indicators fdg002.eps 1-9

22 DataSim 6100 Operators Manual Table 1-4. Pendant Keypad Controls and Indicators Label Element Description A LCD Display Screen B Direct Function Keys C Special Function Key D Palpitation Keys Eight-character display shows prompts, messages, confirmations, results Fifteen of the 16 keys; excluding the SPEC FUNC key Key at the lower right corner (fourth row) of the keypad; labeled SPEC FUNC The second, third, and fourth keys in the third row of the keypad; labeled PAC, PVC1, and PVC2 Allow user to add a palpitation to any other selected rhythm E Mode/Cal Keys Dual function; the first, second, and third keys in the fourth row of the keypad; labeled CPLT/], V-TAC/[, and V-FIB/STD Allow user to select a mode or, when used with Special Functions, to adjust the value of the selected parameter Direct Functions To perform Direct Functions, the user selects the desired rhythm by pressing one of the 15 direct function keys (0-9, PVC1, PVC2, CPLT, V-TAC, and V- FIB). For example, to initiate a bradycardia rhythm, the user presses and releases the 2 key that is labeled BRAD. The Simulator automatically determines the proper time in the cardiac cycle to begin a new rhythm. Special Functions To perform Special Functions, the user presses and releases the SPEC FUNC key, followed by the appropriate two-digit code, found in the printed menus attached to either side of the keypad. The Simulator displays the * symbol in response to the SPEC FUNC key selection. The two-digit function code must be entered when the * prompt is displayed. For example, to select a bigeminy rhythm, the user presses the SPEC FUNC key followed by the code 1-10

23 Introduction and Specifications Instrument Familiarity Functions can be selected in any order to simulate virtually any patient condition sequence. After the code is input, the following prompt displays: ], [ or STD At this prompt, the user can adjust the value of the parameter as desired: ] - Increases parameter value; momentarily displays at max when maximum value is reached [ - Decreases parameter value; momentarily displays at min when minimum value is reached STD - Resets parameter value to the standard value Some of the Special Functions are actually programmed sequences of rhythms or events. Table 1-5 describes the codes and functions. Table 1-5. Pendant Keypad Codes and Functions Code Function Description 00 NORMAL SINUS Provides a convenient way to return to normal sinus rhythm at a rate of 70 BPM 01 SINUS TACHYCARDIA 02 SINUS BRADYCARDIA Rapid regular rhythm with normal P wave and heart rate of 140 BPM Slow regular rhythm with normal P wave and heart rate of 35 BPM 03 ASYSTOLE No beats but very small irregular signal remains 04 ATRIAL FLUTTER 05 ATRIAL FIBRILLATION 06 2nd DEGREE AV BLOCK I Regular ventricular rhythm; atrial flutter with 4:1 conduction Rapid irregular atrial signal with no real P waves; irregular ventricular rate Wenckebach; irregular rhythm with normal P waves; PR interval lengthens progressively until a dropped beat occurs and cycle repeats. 1-11

24 DataSim 6100 Operators Manual Table 1-5. Pendant Keypad Codes and Functions (cont.) Code Function Description 07 2nd DEGREE AV BLOCK II 08 3rd DEGREE AV BLOCK Slow regular rhythm with normal P wave; PR interval in conduced beats is normal; 3:1 block Slow regular ventricular rhythm; regular atrial rhythm; independent atrial and ventricular rhythms 09 PAC INSERT Premature atrial contraction; a single PAC is inserted into the current rhythm. 10 PVC1 INSERT Premature ventricular contraction; a Single PVC1 is inserted into the current. 11 PVC2 INSERT Premature ventricular contraction; a single PVC2 is inserted into the current. 12 COUPLET Irregular rhythms with frequent couplets and 1 pair of ventricular beats; PVCs are premature; compensatory pause follows couplet. 13 VENTRICULAR TACHYCARDIA 14 VENTRICULAR FIBRILLATION 15 ATRIAL TACHYCARDIA 16 ATRIAL TACHYCARDIA/ ABERRANCY 17 FREQUENT PACs 18 PEDIATRIC TACHYCARDIA 19 1st DEGREE AV BLOCK Irregular, rapid rhythm with irregular, successive PVCs; no P waves Irregular, rapid, chaotic waveforms with no QRS ATRIAL Rapid, regular rhythm with biphasic P Rapid, regular rhythms with biphasic P wave and notched wide QRS. Irregular rhythm with frequent premature PACs and a biphasic P wave Rapid regular rhythm with tall R wave and narrow QRS BLOCKS Normal beats except with long PR interval of.25 sec 1-12

25 Introduction and Specifications Instrument Familiarity 1 Table 1-5. Pendant Keypad Codes and Functions (cont.) Code Function Description 20 BUNDLE BRANCH BLOCK 22 ACCELERATED JUNCTIONAL Wide QRS complexes; regular rhythm with a PR interval of.16 sec JUNCTIONAL Regular rhythm with inverted P wave and short PR interval 23 JUNCTIONAL Slow regular rhythm with inverted P wave and short PR interval 24 FREQUENT PJCs Irregular rhythm with frequent, premature PJCs, followed by a pause; inverted P wave and short PR interval VENTRICULAR 26 IDIOVENTRICULAR Slow regular rhythm, no P waves, wide QRS 27 BIGEMINY Irregular rhythm alternates between PVC and normal beat. 28 UNIFOCAL PVCs Frequent, premature unifocal PVCs followed by pause; PVC has wide QRS. 29 MULTIFOCAL PVCs Regular rhythms with frequent PVCs that alternate between type 1 and type 2; pause follows PVCs 30 TRIPLET Frequent runs of 3 consecutive PVCs PACEMAKER 31 VENTRICULAR Pacer artifact precedes QRS. Regular rhythm, no P waves, wide QRS 32 ATRIAL Normal rhythm, pacer artifact precedes P wave. 33 AV SEQUENTIAL Prolonged PR interval; pacemaker artifact precedes P and QRS waves. Wide QRS. 1-13

26 DataSim 6100 Operators Manual Table 1-5. Pendant Keypad Codes and Functions (cont.) Code Function Description 34 SENSE and CAPTURE FAIL 35 FAILURE TO CAPTURE 38 CARDIAC FAILURE Frequent loss of capture, low amplitude escape beat, sensing failure of escape beat No capture; pacer artifact amplitude is 8 mv with 1 msec duration. MISC ECG Intermittent PVCs and couplet followed by ventricular tachycardia, followed by ventricular fibrillation, followed by asystole 39 ST ELEVATION Regular rhythm with ST Elevation at 2 mm 80 msec after J point 40 ST DEPRESSION Regular rhythm with ST Depression at 3 mm 80 msec after J point 41 AGONAL No P waves; wide complexes with periods of asystole 42 VENTRICULAR ASYSTOLE No QRS, regular atrial rhythm 43 CONVERSION Vfib with CPR followed by Vfib without CPR for 2 seconds prior to defib: Defib artifact, Brady rhythm with CPR, Brady rhythm without CPR, followed by NSR ECG ARTIFACT 46 DEFIBRILLATION Positive and negative baseline saturation; artifact is automatically followed by pre-selected rhythm (see #59 below) CYCLE ARTIFACT 48 ECG/RESP ARTIFACT Artifact amplitudes 0.1, 0.4, and 0.7 mv p-p; use ] and [ keys or eliminate with STD key. Artifact amplitudes 0.4, 0.6 and 1.0 mv peak to peak; use ] and [ keys or eliminate with STD key. 1-14

27 Introduction and Specifications Instrument Familiarity 1 Table 1-5. Pendant Keypad Codes and Functions (cont.) Code Function Description 49 MUSCLE ARTIFACT Artifact amplitudes 0.4, 0.6 and 1.0 mv peak to peak; use ] and [ keys or eliminate with STD key. 50 CPR CPR artifact a 70/min 53 ECG RATE ADJUST ADJUST Increases or decreases rate in 10% increments; STD returns to standard rate. 54 SIZE ADJUST Increases and decreases ECG, BP, and respiration waveforms or returns them to standard size; use after selecting desired channel. 55 AUTO TREND Automatically varies NSR heart and respiration rates and blood pressures; Vtach episode 4 every 1 hour; trend repeats every 2 hours. 59 RHYTHM SELECT DEFIB CONVERSATION Permits selection of post defib rhythm, which is then automatically inserted after defib artifact. 60 DEFIB DISABLE Disables auto defib sequence RESPIRATION 71 APNEA Thoracic impedance is simulated via ECG output snaps. 72 RESP AT 10 BPM Respiration waveform at 10 BPM 73 RESP AT 20 BPM Respiration waveform at 20 BPM 74 RESP AT 40 BPM Respiration waveform at 40 BPM 75 RESP AT 80 BPM Respiration waveform at 80 BPM 76 CVA COINCIDENCE ECG and respiration are synchronized and timed appropriately for cardiovascular artifact. Impedance drops immediately after each R wave. 1-15

28 DataSim 6100 Operators Manual Table 1-5. Pendant Keypad Codes and Functions (cont.) Code Function Description 77 PEDIATRIC APNEA/BRADY 78 HEART RATE CALIBRATION Intermittent apnea periods; heart rate drops from 140 BPM to 70 BPM each apnea period. CALIBRATION Calibrated heart rates from 30 to 300 BPM 81 LINEARITY/SPEED 2.5 Hz triangular ECG waveform 82 ECG SIZE CALIBRATION 83 ARRHYTHMIA SEQUENCE 84 RESPIRATION SIZE CAL 62 ZERO PRESSURE Cal pulse amplitudes from.25 mv to 2.5 mv Automatic sequence of arrhythmias over 3 minute period of time: NSR, Dropped Beat, AV Pace, V Pace, Atrial Tach, Couplet, RBBB, Triplet, Bigeminy (3 Foci), Vtach Respiratory depth ranging from 0.25 to 2.5 ohm; calibrated for RA-LA lead BLOOD PRESSURE Zeros all three-pressure channels as well as auxiliary CO2 channel 63 PATENT LINE Outputs a 50 mmhg flush waveform on PA channel PA waveform follows flush. Trailing edge of flush and PA pressure waveforms demonstrate ideal frequency characteristics of pressure line. 64 RESONANT LINE Outputs a 50 mmhg flush waveform on PA channel PA waveform follows flush. Trailing edge of flush and PA pressure waveforms demonstrate resonant frequency characteristics of pressure line. 1-16

29 Introduction and Specifications Instrument Familiarity 1 Table 1-5. Pendant Keypad Codes and Functions (cont.) Code Function Description 65 DAMPED LINE Outputs a 50 mmhg flush waveform on PA channel. PA waveform follows flush. Trailing edge of flush and PA pressure waveforms demonstrate damped frequency characteristics of pressure line. 66 CATHETER WHIP 67 PRES/RESP ARTIFACT Pressure artifact caused by motion of catheter; on PA channel Varies level of respiration artifact on pressures PROCEDURES 68 IABP Arterial pressure with cardiac assists pressure pulse, 2:1 augmentation. Simulation only; not interactive with the IABP; output on arterial channel 69 PA WEDGE Outputs a PAW waveform 70 SWAN-GANZ INSERTION PAC and PVC Insertion Output on PA channel: right atrium to right ventricle; right ventricle to pulmonary artery; pulmonary artery to wedged pulmonary artery; wedged pulmonary artery to pulmonary artery The third row of the keypad has three palpitation simulation keys: 9/PAC PVC1 PVC2 A single PAC or PVC can be inserted into any rhythm by pressing one of these keys. The respective PAC or PVC is inserted into the next cardiac cycle. Only one PAC, PVC1, or PVC2 can be inserted at any one time. The eight-character LCD display responds to key entries by displaying the abbreviated function name. 1-17

30 DataSim 6100 Operators Manual Modifier/Cal Mode The bottom row of the keypad has three dual function keys: CPLT/up arrow V-TAC/down arrow V-FIB/STD Pressing one of these keys without first pressing the SPEC FUNC key puts the Simulator into the Modifier/Cal mode. This mode can also be used in conjunction with the functions listed in Table 1-6. Table 1-6. Functions Used in the Modifier/Cal Mode Code Function 53 Rate Adjust 54 Size 78 Heart Rate Cal 70 BPM 82 ECG Size Cal 84 Resp Size Cal Cycle Artifact 48 ECG/Resp Artifact 49 ECG/Muscle Artifact After the Modifier/Cal mode is invoked and one of the functions is selected, the user can press one of these dual function keys to increase, decrease, or reset the standard value for the selected parameter. Pressing any of the remaining keys exits the Modifier/Cal function, retains the parameter level, and simulates the rhythm selected (NSR, Bradycardia, etc.) 1-18

31 Introduction and Specifications Specifications 1 Specifications Dimensions in H x 10 in W x 4.7 in D (33 cm H x 25.4 cm W x cm D) Weight lb (3.2 kg) Power AC power V/240 V, 1.6 A max, Hz; output: +20V, 2.5 A; output power: 50 W max Battery Type V, 1.9 AH sealed lead acid rechargeable Battery Capacity hr Battery Charge Time... 5 to 95 % of complete charge in 14 hr Temperature ºC to 40 ºC Humidity... 80% maximum ECG Output signals... High Level: 1 V/1 mv Heart Rate Range to 300 BPM Accuracy... ±1 % Output Connectors Low Level Lead electrode snaps High Level... Switchcraft 15GM7F Pacemaker Artifact mv, 1 ms Sample Rate (Maximum) sample/s Performance Testing Linearity Hz triangular wave HR Cal Check to 300 BPM Chart Speed Hz square wave Amplitude , 0.50, 1.00, 1.50, 2.00, and 2.50 mv Blood Pressure Output signals High Level... 1 V/100 mmhg Transducer... 5 and 40 µv/v mmhg Exciter Voltage V ac or dc max Static Range... 0 to 250 mmhg, adjustable in 5 % increments Accuracy... ±5 % or 1 mmhg, whichever is greater 1-19

32 DataSim 6100 Operators Manual Waveforms...Static, square wave, and physiological dynamic Output connector...switchcraft 15GM7F Performance Testing Static...0 to 250 adjustable in 5 % increments Square Wave...0 to 250 mmhg adjustable in 5 % increments Respiration Output signals Delta Impedance to 2.50 Ω Lead I Base Impedance Ω Lead I, 750 Ω Lead II Rate Range...0 to 80 BPM Lead...All leads Performance Testing Rate...0, 10, 20, 40, and 80 BPM Delta Impedance , 0.50, 1.00, 1.50, 2.00, and 2.50 Ω Coincidence check General Information Channels...ECG/arrhythmia, respiration, arterial pressure, RA pressure, and auxiliary channel for optional parameters. Fundamental Rhythms and Sequences...Normal sinus rhythm Sinus tachycardia and bradycardia Ventricular and sinus asystole Atrial tachycardia Atrial flutter Fibrillation AV blocks (1st degree, 2nd degree Mobitz I and II, and 3rd degree) Unifocal and multifocal PVCs Ventricular tachycardia Ventricular fibrillation PVCs at 1 to 35/min for any rhythm Couplet Triplet Bigeminy Junctional Accelerated junctional PACs and PJCs Atrial tachycardia with aberrant conduction Idioventricular Agonal ST-segment elevation and depression Pacemaker (atrial, ventricular, and AV sequential) Failure to capture and sense 1-20

33 Introduction and Specifications Accessories 1 Bundle-branch block Cardiac-failure sequence Conversion sequence Accessories The following are accessories for the Simulator. Table 1-7 lists standard accessories shipped with the tester. Table 1-8 lists optional accessories that must be ordered separately. To order, contact your Fluke Biomedical equipment dealer and use the Fluke Biomedical part numbers provided Table 1-7. Standard Accessories Description Part Number Operators Manual LCD Pendant (Keyboard) Controller VAC Battery Charger (Wall Mount) VAC Battery Charger B Cardiac Output Injectate B Marquette CO module B Cardiac Output Injectate B Interactive IABP Datascope Personality Module B Normal/Diseased Heart Personality Module

34 DataSim 6100 Operators Manual Table 1-8. Optional Accessories (Series 90) Blood Pressure Cables Description Part Number BCI International (6 M) Criticare Systems (1100) (6 M) Critikon (Dinamap Plus) (6 M) Datascope (800 series) (6 F) Fakuda Denshi (DS 3300) (12 M) GE Marquette Medical (7000/Early Tram - AR series only) (8 M) GE Marquette Medical (Dash, Eagle, Solar, Tram, and MacLab) (rectangular - 11 M) GE Marquette Medical (PDS 3100) (6 F) GE Marquette Medical (PPG/E for M: DR, IR, IM4, VR series) (6 F) Hewlett Packard 40 µv (78300, - 500, - 800, and Merlin/Viridia/Omnicare) (12 M) Hewlett Packard 5 µv (78300, - 500, - 800) Invivo Research (Omni-Trak) (6 M) Ivy Biomedical (6 M) Kontron (Mini-, Super-, Color-Mon) (6 M) MDE (Escort series) (6 M) Mennen Medical (All) (6 M) North American Drager (Vitalert 2000) (6 M)

35 Introduction and Specifications Accessories 1 Table 1-8. Optional Accessories (Series 90) Blood Pressure Cables (cont.) Description Part Number Ohmeda (Modulus CD-CV) (6 M) Physio Control (All) (6 M) Protocol Systems (Propaq Series 100) (6 M) Quinton (Q-Cath) (6 M) Siemens Mingo (Cath System) b (7 F) SpaceLabs (1050, 1700, PCMS series) (for use with SpaceLabs adapters and when testing the multiparameter Ultraview Command Module) (6 M) SpaceLabs (Alpha 9, Alpha 14, 703R) (5 M) Unterminated BP cable (7-pin DIN, one end only) Witt Biomedical (6 F) BCI International (6 M)

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37 Chapter 2 Operation Contents Page Introduction Size Adjustments Calibration Heart Rate Adjustment Artifact Simulation Respiration Defibrillation Training Blood Pressure Simulation Personality Modules (Optional Special Functions) Interactive IABP Personality Modules Cardiac Output Personality Modules Blood Pressure Cables Connector Interface Pin Definitions

38 DataSim 6100 Operators Manual 2-2

39 Introduction Operation Introduction 2 The following describes procedures for using the Simulator to demonstrate and train in situations that healthcare professionals experience on a daily basis. Such situations include normal and abnormal blood pressures, arrhythmias, and defibrillation. Size Adjustments The Size Adjust function, Special Function 54, lets the user adjust the waveform size up or down from the STD level. This function is intended for in-service and demonstration applications when size adjustments may be helpful in demonstrating a clinical situation, such as increasing the PA wedge pressure to simulate LV heart failure. Table 2-1 lists waveform amplitudes for each channel. Table 2-1. Waveform Amplitudes Channel Parameter 1 ECG 2 ART 3 PA 4 RA 5 AUX 6 RESP To adjust the size of a waveform channel: 1. Using the keypad, press SPEC FUNC, followed by the numbers 54. The keypad briefly displays: SIZE 2-3

40 DataSim 6100 Operators Manual followed by the prompt: CHAN? 2. Enter the desired channel number by pressing the numbers 1-6. The following prompt displays: ], [ or STD 3. Press ] to increase or [ to decrease the value, or press STD to reset to the standard level. Table 2-2 shows the effect of incremental waveform amplitude size adjustments on the parameters. Table 2-2. Effects of Size Adjustments on Parameters Channel/ Parameter (1) ECG R Wave Amplitude (mv) STD mv (2) ART SYS/DIAS Mean (mmhg) 116/ / / / / / / / (3) PA SYS/DIAS Mean (mmhg) 14/6 9 21/ / / /19 27/\ 48/ / /28 42 (4) RA Mean (mmhg) (5) AUX (CO) (6) RESP (RA-LA) (Ω) Not Adjustable

41 Operation Calibration 2 Note Pressure and R wave values are defined for normal sinus beats only. To obtain non-varying pressure valves, select SPEC FUNC 67 and decrease minimum level. For calibration of performance check applications, use SPEC FUNC 78 (Heart Rate Cal), SPEC FUNC 81 (Linearity/Speed), SPEC FUNC 82 (ECG Size Cal), and SPEC FUNC 84 (Resp Size Cal). Calibration The Calibration functions, Special Functions 78, 82, and 84, let the user adjust calibration levels for heart rate, linearity/speed, ECG size, and respiration size, as illustrated in Table 2-3. Table 2-3. Calibration Functions Adjusment Levels (78) HR CAL (BPM) Function (82) ECG/SIZE/CAL (mv) (84) RESP SIZE CAL (Ω) STD

42 DataSim 6100 Operators Manual Table 2-3. Calibration Functions (cont.) Adjusment Levels (78) HR CAL (BPM) Function (82) ECG/SIZE/CAL (mv) (84) RESP SIZE CAL (Ω) To adjust calibration levels: 1. Using the keypad, press SPEC FUNC, followed by the numbers 78, 82, or 84. For example, using the number 78, the keypad briefly displays: followed by the prompt: ECG RATE ], [ or STD 2. Press ] to increase or [ to decrease the value, or press STD to reset to the standard level. Heart Rate Adjustment The Rate Adjust function, Special Function 53, offers the user the option of adjusting rates up or down in 10% increments. Table 2-4. lists the heart rates available for the various rhythms. On power-up, each rhythm defaults to the standard heart rate (STD). 2-6

43 Operation Artifact Simulation 2 Table 2-4. Heart Rates Obtained via Rate Adjust Special Function RHYTHM -40% -30% -20% -10% STD +10% +20% +30% Bradycardia Ventricular Junctional Normal Sinus Sinus Tach Atrial Tach Atrial Fib Note For performance check applications, the Heart Rate Calibration, Special Function 78 (ECG RATE), provides calibrated heart rates from 30 to 300 BPM, See Table 2-3. To adjust the heart rate: 1. Using the keypad, press SPEC FUNC, followed by the number 53. The keypad briefly displays: followed by the prompt: RATE ], [ or STD 2. Press ] to increase or [ to decrease the value, or press STD to reset to the standard level. Artifact Simulation Various types of artifact can be superimposed on the ECG. The type and level of artifact is selected via the Special Functions 47, 48, and

44 DataSim 6100 Operators Manual To enable an artifact: 1. Using the keypad, press SPEC FUNC, followed by the numbers 47, 48, or 49. For example, using the number 47, the keypad briefly displays: followed by the prompt: 60 CYCLE ], [ or STD 2. Press ] to increase or STD to reset to standard level. The [ capability is not available. Table 2-5 shows the effect of artifact modification on the parameters. Table 2-5. Artifact Modifier Effects FUNC TYPE STD ECG 60 Hz mv 48 ECG RESP mv 49 ECG MUSCLE mv Respiration The Simulator provides a varying thoracic impedance signal via all 10 ECG electrode output snaps. Several respiration rates from apnea to 80 BPM can be selected. After a respiration rate has been selected, the respiration rate remains fixed during subsequent rhythm selections or until a new respiration rate is selected. To vary the amplitude of the thoracic impedance signal (R): 1. Using the keypad, press SPEC FUNC, followed by the numbers 54. The keypad briefly displays: SIZE 2-8

45 Operation Defibrillation Training 2 followed by the prompt: CHAN? 2. Enter number 6. The following prompt displays: ], [ or STD Press ] to increase, [ to decrease, or STD to reset to standard level. Respiration amplitudes differ, depending upon which lead is monitored. Tables 2-2 and 2-3 list amplitudes for the RA-LA lead. Note For calibration applications, use the Respiration Size Cal function, Special Function 84, to display impedance amplitudes. Pressure waveforms are modulated by the respiration waveforms to simulate respiration artifact. The respiration artifact level can be varied using Pressure/Respiration Artifact, Special Function 67. Cardiovascular artifact or ECG/Respiration coincidence can be simulated by selecting the CVA Coincidence, Special Function 76. The impedance signal is synchronized with the ECG. Impedance decreases after each R wave, simulating a decrease in impedance due to an increase in pulmonary blood volume during systole. Defibrillation Training The Defibrillation Training mode lets the user interface the Simulator with the Laerdal Arrhythmia Anne and the Armstrong Chris Clean manikins for realistic defibrillation and ECG paddle monitoring training. To train in defibrillation using a manikin: 1. Follow the guidelines provided by the training manikin for proper cable connection. 2. Plug the torso skin cable into the DEFIB MANIKIN jack. 3. Power on the Simulator. 4. On the keypad, select a life-threatening arrhythmia, such as V-FIB 2-9

46 DataSim 6100 Operators Manual 5. To enable the automatic defib conversion feature and select the post defib rhythm: a. Press and release the SPEC FUNC key b. Enter code number 59 to initiate the DEFIB CONVERSION Rhythm Select function. The keypad displays: SEL RTHM c. Select the desired post-defib rhythm by pressing a Direct Function key, or by pressing the SPEC FUNC key followed by the two-digit code number of the desired rhythm. Note If a post defib rhythm is not programmed, the defib artifact is followed by asystole until another rhythm is manually selected. 6. To initiate the defibrillation sequence: Defibs equipped with apex/sternum paddles: Firmly place the paddles on the electrodes located on the manikin chest skin or torso cover. Defibs equipped with disposable electrodes: Plug in adapters and connect cables from defib to adapter snaps. 7. Charge the defib to 25 joules for Arrhythmia Anne or up to 400 joules for Chris Clean. 8. Press the SIMULATE DEFIB button. W Caution To avoid damage to the Simulator or adverse affects on its performance, refer to the Arrhythmia Anne and Chris Clean instruction manuals for the proper procedures and use of the defibrillator on the manikin. Under no circumstances should a defibrillator be discharged directly into the Simulator. After defibrillation of the manikin, the Simulator simulates defibrillation artifact, followed by the pre-selected rhythm. The programmed post defibrillation rhythm can be changed at any time. 2-10

47 Operation Blood Pressure Simulation 2 9. To repeat a sequence, select another life-threatening rhythm and defibrillate. The Defib Conversion feature can be disabled at any time by selecting SPEC FUNC 60 (DEFIB DISABLE). Manually Initiating Defib Sequence To initiate the defib sequence manually, press the SIMULATE DEFIB switch on the Simulator front panel or select SPEC FUNC 46 (DEFIB). When this function is selected, defib artifact is simulated. If a post defib rhythm has been programmed, the defib artifact is automatically followed by the programmed rhythm. Blood Pressure Simulation The Simulator can assist in checking the calibration of an invasive pressure monitor. It is important to zero each pressure channel of the monitor. To check the calibration of the monitor: 1. Connect BP cables from the Simulator to the monitor. 2. Zero the monitor before powering on the Simulator. When the Simulator is powered on, it automatically outputs an NSR ECG waveform and the normal BP waveforms. Alternatively, power on the Simulator and select SPEC FUNC 62 (0mmHg). Up to three pressure channels can be zeroed simultaneously via channel 2-4. Use the pressure monitor manufacturer suggested procedure to obtain a 0 mmhg pressure baseline of each pressure channel. 3. After successfully adjusting the monitor zero point, select SPEC FUNC 79 to check calibration of the pressure monitor. 4. Select the desired pressure waveform via Special Function or Direct Function keys to output dynamic BP waveforms on all three channels. Pressure cables are available to connect the Simulator to most pressure monitors. Table 2-2 defines systolic, diastolic, and mean values of the dynamic pressure waveforms for normal sinus beats. If the monitor or recorder does not closely agree with these pressure values, any of the following may apply. The monitor or recorder is not calibrated or properly zeroed. 2-11

48 DataSim 6100 Operators Manual The inter-connect cable is not supplying an excitation reference voltage required by the Simulator. The inter-connect cable is wired to the wrong signal output pin. Respiration artifact on the pressures modulates the pressure values in sync with the respiration cycle. This artifact significantly alters the systolic/diastolic values. 5. To remove respiration artifact, select SPEC FUNC 67 (PRES RESP) and decrease to the minimum level. Personality Modules (Optional Special Functions) Optional Personality Modules increase the number of Special Functions available in the Simulator. These can be plugged into the front panel connector and provide the following scenarios: Interactive IABP helps students practice setting inflation/deflation timings. The Simulator can be interfaced with all Kontron, Datascope, and Aries balloon pumps. The Simulator responds to the inflation/deflation timing of the balloon pump by changing the timing and shape of augmented arterial pressures. Cardiac Output simulates normal and abnormal thermal dilution curves by connecting the Simulator to any cardiac output computer that accepts the Edwards 3-pin catheters. PALS Training an optional Pediatric ECG Personality Module used with the DEFIB training feature during Pediatric (PALS) training workshops. Note Power off the Simulator before inserting or removing a Personality Module. Each module has a function menu listing the functions and code numbers within the module s memory. These functions are assigned code numbers between 89 and 99. Available Personality Modules are listed in Table

49 Operation Personality Modules (Optional Special Functions) 2 Table 2-6. Personality Modules MDE Ref # Part # Description Additional Detail B Intra-Aortic Balloon Assist (manual IABP waveform selection) Early Inflation Late Inflation Early Deflation Late Deflation Proper Timing B Pediatric ECG Sinus Arrhythmia Junctional Junctional Escape Wandering Pacer Hyperkalemia Enlarged Atrium CPR Artifact Sinus Tachycardia B Intra-Cranial Pressures (ICP) Normal ICP Normal with Resp Artifact Damped with Resp Artifact Cough Artifact Hypercapnia B Wave and A Wave Jugular Comp B Advanced Pacer Undersensing Oversensing Muscle Artifact Oversensing tall T Waves Fusion Pseudo Fusion Runaway Pacer PAC with DVI Pacer Retrograde VA Conduction 2-13

50 DataSim 6100 Operators Manual Table 2-6. Personality Modules (cont.) MDE Ref # Part # Description Additional Detail B MCL1 Atrials Normal Sinus Rhythm Bradycardia Sinus Arrest Atrial Tach Atrial Flutter Atrial Fib PAC PAT B MCL1 Blocks Normal Sinus Rhythm 1 st degree AV block 2 nd degree AV block Type I 2 nd degree AV block Type II 3 rd degree AV block RBBB LBBB B MCL1 Ectopy/ Aberrancy B Left Heart Pressures Normal Sinus Rhythm Right PVC Left PVC Multifocal PVC s R on T Bigeminy Atrial Fib with Aberrancy Cardiac Failure Sequence Pressure Zero Normal AO, LV, LA AO to LV Insertion LV to AO Pullback AO, LV, and LA with PVCs B Valve Disease Mitral Stenosis Mitral Regurgitation Aortic Stenosis Aortic Regurgitation LV/AO Pullback with AS LV/AO Pullback with AR B Lead Set Includes three previous modules B Lead Normal ECG 2-14

51 Operation Personality Modules (Optional Special Functions) 2 Table 2-6. Personality Modules (cont.) MDE Ref # Part # Description Additional Detail B Lead Anterior infarct B Lead Inferior infarct Leads I, II, III, AVR, AVL, AVF, V B ST Segments 2.5 mm Horizontal ST Depression 2.5 mm Horizontal ST Elevation ST Downslope Depression ST Upslope Elevation ST Upslope Depression 45 ST Upslope Depression 30 ST Upslope Depression B MCL1 Set (07, 08, 09) B Cardiac Output (CO)(Injectate Temp = 0 C) B Marquette CO Module B Cardiac Output (Injectate Temp = 25 C) B Defib Training Module B Interactive IABP/Kontron (K2000 and KAAT) B Interactive IABP/Datasco pe Includes , and Injectate temp for use with Injectate temp for use with (7, 10, K2000, KAAT ) System

52 DataSim 6100 Operators Manual Table 2-6. Personality Modules (cont.) MDE Ref # Part # Description Additional Detail B Interactive IABP/Datascope B Interactive IABP/Aries B Normal/Disease Heart System 90 Early Inflation Late Inflation Early Deflation Late Deflation Proper Timing Interactive IABP Personality Modules The Interactive Intra-Aortic Balloon Pump Personality Modules are used with the Simulator and Kontron, Datascope System 80, Datascope System 90, and Aries monitors. Invasive arterial BP and sync timing cables are included with each module. To generate the special waveforms: 1. Determine the need for a balloon according to the monitor used. Datascope 90: It is essential that a balloon (or suitable replacement) be connected to the Balloon Output connector for proper operation of the Datascope 90 pump. Datascope 80, Kontron Aries: It may be necessary to defeat the alarm by connecting a balloon or suitable replacement to the Balloon Output connector. 2. Connect Datascope/Kontron/Aries ECG cable to the Simulator ECG snap connectors. 3. Insert the Interactive IABP module into the Simulator Personality Module connector. 4. Power on the Simulator. 5. Connect the following cables to their respective monitors: 2-16