Fluke 6100 User Manual

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DataSim 6100

Patient Simulator

Operators Manual

PN 2242959 February 2008

Warranty and Product Support

Fluke Biomedical warrants this instrument against defects in materials and workmanship for one year from the date of original purchase. During the warranty period, we will repair or at our option replace, at no charge, a product that proves to be defective, provided you return the product, shipping prepaid, to Fluke Biomedical. This warranty covers the original purchaser only and is not transferable. The warranty does not apply if the product has been damaged by accident or misuse or has been serviced or modified by anyone other than an authorized Fluke Biomedical service facility. NO OTHER WARRANTIES, SUCH AS FITNESS FOR A PARTICULAR PURPOSE, ARE EXPRESSED OR IMPLIED. FLUKE SHALL NOT BE LIABLE FOR ANY SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES OR LOSSES, INCLUDING LOSS OF DATA, ARISING FROM ANY CAUSE OR THEORY.

This warranty covers only serialized products and their accessory items that bear a distinct serial number tag. Recalibration of instruments is not covered under the warranty

This warranty gives you specific legal rights and you may also have other rights that vary in different jurisdictions. Since some jurisdictions do not allow the exclusion or limitation of an implied warranty or of incidental or consequential damages, this limitation of liability may not apply to you. If any provision of this warranty is held invalid or unenforceable by a court or other decision-maker of competent jurisdiction, such holding will not affect the validity or enforceability of any other provision.

07/07

Notices

© 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.

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 email

techservices@flukebiomedical.com

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.

or call 1-800- 648-7952 or

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.

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

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 1-800-648-7952 or 1-425-446-

6945.

Repair and calibration:

To find the nearest service center, go to www.flukebiomedical.com/service

In the U.S.A.: Cleveland Calibration Lab Tel: 1-800-850-4606 Email: globalcal@flukebiomedical.com

Everett Calibration Lab Tel: 1-888-993-5853 Email: service.status@fluke.com

In Europe, Middle East, and Africa: Eindhoven Calibration Lab Tel: +31-402-675300 Email: ServiceDesk@fluke.com

In Asia: Everett Calibration Lab Tel: +425-446-6945 Email: service.international@fluke.com

material around the instrument.

, or

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.

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.

Chapter Title Page

1 Introduction and Specifications.............................................. 1-1

Introduction .......................................................................................... 1-3

Features................................................................................................. 1-3

General Safety Considerations.............................................................. 1-4

Symbols ............................................................................................ 1-4

Warnings and Cautions..................................................................... 1-4

Instrument Familiarity .......................................................................... 1-5

Front Panel........................................................................................ 1-5

Pendant Keypad Controller............................................................... 1-9

Direct Functions............................................................................ 1-10

Special Functions.......................................................................... 1-10

PAC and PVC Insertion ................................................................ 1-17

Modifier/Cal Mode ....................................................................... 1-18

Specifications........................................................................................ 1-19

Accessories ........................................................................................... 1-21

2 Operation .................................................................................. 2-1

Introduction .......................................................................................... 2-3

Size Adjustments .................................................................................. 2-3

Calibration ............................................................................................ 2-5

Heart Rate Adjustment.......................................................................... 2-6

Artifact Simulation ............................................................................... 2-7

Respiration............................................................................................ 2-8

Defibrillation Training.......................................................................... 2-9

Blood Pressure Simulation.................................................................... 2-11

Personality Modules (Optional Special Functions)............................... 2-12

Interactive IABP Personality Modules.............................................. 2-16

Cardiac Output Personality Modules ................................................ 2-18

Blood Pressure Cables .......................................................................... 2-19

Connector Interface Pin Definitions...................................................... 2-21

3 Maintenance, Service, and Calibration................................... 3-1

Maintenance.......................................................................................... 3-3

Avoiding Damage............................................................................. 3-3

Cleaning............................................................................................ 3-3

DataSim 6100

Operators Manual

Battery Charging and Replacement...................................................... 3-4

Service and Calibration ........................................................................ 3-5

List of Tables

Table Title Page

1-1. Symbols.............................................................................................. 1-4

1-2. Simulator Front Panel Controls and Indicators .................................. 1-7

1-3. Lead ECG Amplitude......................................................................... 1-8

1-4. Pendant Keypad Controls and Indicators ........................................... 1-10

1-5. Pendant Keypad Codes and Functions ............................................... 1-11

1-6. Functions Used in the Modifier/Cal Mode......................................... 1-18

1-7. Standard Accessories ......................................................................... 1-21

1-8. Optional Accessories (Series 90) Blood Pressure Cables................... 1-22

2-1. Waveform Amplitudes ....................................................................... 2-3

2-2. Effects of Size Adjustments on Parameters........................................ 2-4

2-3. Calibration Functions ......................................................................... 2-6

2-4. Heart Rates Obtained via Rate Adjust Special Function .................... 2-7

2-5. Artifact Modifier Effects.................................................................... 2-8

2-6. Personality Modules........................................................................... 2-13

2-7. Appropriate Pressure Simulator Interface Cables............................... 2-19

2-8. ECG Connectors ................................................................................ 2-21

2-9. Pressure Connectors ........................................................................... 2-22

iii

DataSim 6100

Operators Manual

List of Figures

Figure Title Page

1-1. Simulator Front Panel Controls and Indicators .................................. 1-6

1-2. Pendant Keypad Controls and Indicators ........................................... 1-9

2-1. Pressure Cable Wiring for Monitor with 5 µV/V mmHg Sensitivity . 2-20 2-2. Pressure Cable Wiring for Monitor with 40 µV/V mmHg Sensitivity 2-21

2-3. Connector Pin Assignments ............................................................... 2-22

DataSim 6100

Operators Manual

Chapter 1

Introduction and Specifications

Contents Page

Introduction ................................................................................. 1-3

Features........................................................................................ 1-3

General Safety Considerations..................................................... 1-4

Symbols.................................................................................... 1-4

Warnings and Cautions ............................................................ 1-4

Instrument Familiarity ................................................................. 1-5

Front Panel ............................................................................... 1-5

Pendant Keypad Controller ...................................................... 1-9

Direct Functions ................................................................... 1-10

Special Functions.................................................................. 1-10

PAC and PVC Insertion........................................................ 1-17

Modifier/Cal Mode............................................................... 1-18

Specifications............................................................................... 1-19

Accessories .................................................................................. 1-21

1-1

DataSim 6100

Operators Manual

1-2

Introduction and Specifications Introduction

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

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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 Description

X Hazardous voltage W Important information; refer to manual. P 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

Introduction and Specifications Instrument Familiarity

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

DataSim 6100

Operators Manual

1 2

DataSim 6100

Patient Simulator

NSR1TACH2BRAD3ASYS

A-FLTR5A-FIB62AVB172AVB2

3AVB9PAC

V-TAC

PVC1 PVC2

SPEC

V-FIB

STD

FUNC

CPLT

KEYPAD

POWER

ECG

ART

On Off

LL (+)

LA (-)

(-)

AUX

PERSONALITY

MODULE

MANKIN

SIMULATE

DEFIB

1-6

Figure 1-1. Simulator Front Panel Controls and Indicators

fdg001.eps

Introduction and Specifications Instrument Familiarity

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

This battery operated unit is rechargeable with the supplied charger.

C ECG Snap

Connectors

D Pressure Output

Connectors

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.

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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

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 V3 +.60 V4 +1.0 V5 +1.5 V6 + 1.0

Jack used to recharge battery

The unit can be operated while recharging.

1-8

Introduction and Specifications Instrument Familiarity

Pendant Keypad Controller

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

NSR1TACH2BRAD3ASYS

A-FLTR5A-FIB62AVB172AVB2

3AVB9PAC

V-TAC

PVC1 PVC2

SPEC

V-FIB

STD

FUNC

CPLT

Figure 1-2. Pendant Keypad Controls and Indicators

fdg002.eps

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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

E Mode/Cal

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

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

Introduction and Specifications Instrument Familiarity

27. 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

03 ASYSTOLE No beats but very small irregular signal

04 ATRIAL

FLUTTER

05 ATRIAL

FIBRILLATION

06 2nd DEGREE AV

BLOCK I

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

remains 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.

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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

09 PAC INSERT Premature atrial contraction; a single

10 PVC1 INSERT Premature ventricular contraction; a

11 PVC2 INSERT Premature ventricular contraction; a

13 VENTRICULAR

14 VENTRICULAR

15 ATRIAL

16 ATRIAL

17 FREQUENT

18 PEDIATRIC

19 1st DEGREE AV

COUPLET Irregular rhythms with frequent couplets

TACHYCARDIA

FIBRILLATION

TACHYCARDIA

TACHYCARDIA/ ABERRANCY

PACs

TACHYCARDIA

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

PAC is inserted into the current rhythm.

Single PVC1 is inserted into the current.

single PVC2 is inserted into the current.

and 1 pair of ventricular beats; PVCs are premature; compensatory pause follows couplet.

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

Introduction and Specifications Instrument Familiarity

Table 1-5. Pendant Keypad Codes and Functions (cont.)

Code Function Description

20 BUNDLE

BRANCH BLOCK

22 ACCELERATED

JUNCTIONAL

23 JUNCTIONAL Slow regular rhythm with inverted P

24 FREQUENT PJCs Irregular rhythm with frequent,

26 IDIOVENTRICULAR Slow regular rhythm, no P waves,

27 BIGEMINY Irregular rhythm alternates between

28 UNIFOCAL PVCs Frequent, premature unifocal PVCs

29 MULTIFOCAL

PVCs

30 TRIPLET Frequent runs of 3 consecutive PVCs

31 VENTRICULAR Pacer artifact precedes QRS. Regular

32 ATRIAL Normal rhythm, pacer artifact precedes

33 AV SEQUENTIAL Prolonged PR interval; pacemaker

Wide QRS complexes; regular rhythm with a PR interval of .16 sec

JUNCTIONAL

Regular rhythm with inverted P wave and short PR interval

wave and short PR interval

premature PJCs, followed by a pause; inverted P wave and short PR interval

VENTRICULAR

wide QRS

PVC and normal beat.

followed by pause; PVC has wide QRS.

Regular rhythms with frequent PVCs that alternate between type 1 and type 2; pause follows PVCs

PACEMAKER

rhythm, no P waves, wide QRS

P wave.

artifact precedes P and QRS waves. Wide QRS.

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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

39 ST ELEVATION Regular rhythm with ST Elevation at 2

40 ST DEPRESSION Regular rhythm with ST Depression at 3

41 AGONAL No P waves; wide complexes with

42 VENTRICULAR

ASYSTOLE

43 CONVERSION Vfib with CPR followed by Vfib without

46 DEFIBRILLATION Positive and negative baseline

47 60 CYCLE

ARTIFACT

48 ECG/RESP

ARTIFACT

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

mm 80 msec after J point

periods of asystole No QRS, regular atrial rhythm

CPR for 2 seconds prior to defib: Defib artifact, Brady rhythm with CPR, Brady rhythm without CPR, followed by NSR

ECG ARTIFACT

saturation; artifact is automatically followed by pre-selected rhythm (see #59 below).

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.

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Introduction and Specifications Instrument Familiarity

Table 1-5. Pendant Keypad Codes and Functions (cont.)

Code Function Description

49 MUSCLE

ARTIFACT

50 CPR CPR artifact a 70/min

53 ECG RATE

ADJUST

54 SIZE ADJUST Increases and decreases ECG, BP, and

55 AUTO TREND Automatically varies NSR heart and

DEFIB CONVERSATION

59 RHYTHM

SELECT

60 DEFIB DISABLE Disables auto defib sequence

71 APNEA Thoracic impedance is simulated via

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

Artifact amplitudes 0.4, 0.6 and 1.0 mV peak to peak; use ] and [ keys or eliminate with STD key.

ADJUST

Increases or decreases rate in 10% increments; STD returns to standard rate.

respiration waveforms or returns them to standard size; use after selecting desired channel.

respiration rates and blood pressures; Vtach episode 4 every 1 hour; trend repeats every 2 hours.

Permits selection of post defib rhythm, which is then automatically inserted after defib artifact.

RESPIRATION

ECG output snaps.

ECG and respiration are synchronized and timed appropriately for cardiovascular artifact. Impedance drops immediately after each R wave.

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DataSim 6100

Operators Manual

Table 1-5. Pendant Keypad Codes and Functions (cont.)

Code Function Description

77 PEDIATRIC

APNEA/BRADY

78 HEART RATE

CALIBRATION 81 LINEARITY/SPEED 2.5 Hz triangular ECG waveform 82 ECG SIZE

CALIBRATION 83 ARRHYTHMIA

SEQUENCE

84 RESPIRATION

SIZE CAL

BLOOD PRESSURE

62 ZERO

PRESSURE 63 PATENT LINE Outputs a 50 mmHg flush waveform on

64 RESONANT LINE Outputs a 50 mmHg flush waveform on

Intermittent apnea periods; heart rate drops from 140 BPM to 70 BPM each apnea period.

CALIBRATION

Calibrated heart rates from 30 to 300 BPM

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

Zeros all three-pressure channels as well as auxiliary CO2 channel

PA channel PA waveform follows flush. Trailing edge

of flush and PA pressure waveforms demonstrate ideal frequency characteristics of pressure line.

PA channel PA waveform follows flush. Trailing edge

of flush and PA pressure waveforms demonstrate resonant frequency characteristics of pressure line.

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Introduction and Specifications Instrument Familiarity

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

68 IABP Arterial pressure with cardiac assists

69 PA WEDGE Outputs a PAW waveform 70 SWAN-GANZ

INSERTION

Pressure artifact caused by motion of catheter; on PA channel

Varies level of respiration artifact on pressures

PROCEDURES

pressure pulse, 2:1 augmentation. Simulation only; not interactive with the

IABP; output on arterial channel

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

PAC and PVC Insertion

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

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 47 60 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

Introduction and Specifications Specifications

Specifications

Dimensions ........................................................... 13 in H x 10 in W x 4.7 in D

Weight.................................................................... .05 lb (3.2 kg)

Power

AC power ............................................................ 100 V/240 V, 1.6 A max, 50-60 Hz;

Battery Type ....................................................... 12 V, 1.9 AH sealed lead acid

Battery Capacity ................................................. 20 hr

Battery Charge Time........................................... 5 to 95 % of complete charge in 14 hr

Temperature .......................................................... 10 ºC to 40 ºC

Humidity ................................................................ 80% maximum

ECG

Output signals..................................................... High Level: 1 V/1 mV

Heart Rate

Range ................................................................. 30 to 300 BPM

Accuracy ............................................................. ±1 %

Output Connectors

Low Level............................................................ 12-Lead electrode snaps

High Level........................................................... Switchcraft 15GM7F

Pacemaker Artifact ............................................. -8 mV, 1 ms

Sample Rate (Maximum) .................................... 250 sample/s

Performance Testing

Linearity .............................................................. 2.5 Hz triangular wave

HR Cal Check ..................................................... 30 to 300 BPM

Chart Speed........................................................ 2.5 Hz square wave

Amplitude............................................................ 0.25, 0.50, 1.00, 1.50, 2.00, and

Blood Pressure

Output signals

High Level........................................................... 1 V/100 mmHg

Transducer.......................................................... 5 and 40 µV/V mmHg

Exciter Voltage.................................................... 10 V ac or dc max

Static Range ....................................................... 0 to 250 mmHg, adjustable in 5 %

Accuracy ............................................................. ±5 % or 1 mmHg, whichever is greater

(33 cm H x 25.4 cm W x 11.94 cm D)

output: +20V, 2.5 A; output power: 50 W max

rechargeable

2.50 mV

increments

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Operators Manual

Waveforms ..........................................................Static, square wave, and physiological

Output connector.................................................Switchcraft 15GM7F

Performance Testing

Static ...................................................................0 to 250 adjustable in 5 % increments

Square Wave ......................................................0 to 250 mmHg adjustable in 5 %

Respiration

Output signals

Delta Impedance .................................................0.25 to 2.50 Ω Lead I

Base Impedance .................................................250 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 .................................................0.25, 0.50, 1.00, 1.50, 2.00, and

Coincidence check

General Information

Channels .............................................................ECG/arrhythmia, respiration, arterial

Fundamental Rhythms and Sequences ..............Normal sinus rhythm

dynamic

increments

2.50 Ω

pressure, RA pressure, and auxiliary channel for optional parameters.

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

Introduction and Specifications Accessories

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 2242959

LCD Pendant (Keyboard) Controller 2392337

120 VAC Battery Charger (Wall Mount) 2184111

220 VAC Battery Charger 2184127

6070-18B Cardiac Output Injectate 2244588

6070-19B Marquette CO module 2244595

6070-20B Cardiac Output Injectate 2244602

6070-29B Interactive IABP Datascope Personality Module

6070-37B Normal/Diseased Heart Personality Module

2244678

2244706

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Operators Manual

Table 1-8. Optional Accessories (Series 90) Blood Pressure Cables

Description Part Number

BCI International 4100-09 (6 M) 2392213

Criticare Systems (1100) 4100-09 (6 M) 2392213

Critikon (Dinamap Plus) 4100-09 (6 M) 2392213

Datascope (800 series) 4100-08 (6 F) 2392208

Fakuda Denshi (DS 3300) 4100-61 (12 M) 2199456

GE Marquette Medical (7000/Early Tram AR series only) 4100-23 (8 M)

GE Marquette Medical (Dash, Eagle, Solar, Tram, and MacLab) 4100-60 (rectangular 11 M)

GE Marquette Medical (PDS 3100) 4100-08 (6 F)

GE Marquette Medical (PPG/E for M: DR, IR, IM4, VR series) 4100-11 (6 F)

Hewlett Packard 40 µV (78300, - 500, 800, and Merlin/Viridia/Omnicare) 4100-05 (12 M)

Hewlett Packard 5 µV (78300, - 500, - 800) 2199400

Invivo Research (Omni-Trak) 4100-09 (6 M)

Ivy Biomedical 4100-09 (6 M) 2392213

Kontron (Mini-, Super-, Color-Mon) 4100-20 (6 M)

MDE (Escort series) 4100-09 (6 M) 2392213

2199508

2199549

2392208

2199474

2199417

2392213

2199495

Mennen Medical (All) 4100-09 (6 M) 2392213

North American Drager (Vitalert 2000) 4100-09 (6 M)

2392213

1-22

Introduction and Specifications Accessories

Table 1-8. Optional Accessories (Series 90) Blood Pressure Cables (cont.)

Description Part Number

Ohmeda (Modulus CD-CV) 4100-90 (6 M) 2392213

Physio Control (All) 4100-09 (6 M) 2392213

Protocol Systems (Propaq Series 100) 4100-09 (6 M)

Quinton (Q-Cath) 4100-62 (6 M) 2199463

Siemens Mingo (Cath System) 4100-42 b (7 F)

SpaceLabs (1050, 1700, PCMS series) (for use with SpaceLabs adapters 7000028-00 and 0120-0551-00 when testing the multiparameter Ultraview Command Module) 4100-09 (6 M)

SpaceLabs (Alpha 9, Alpha 14, 703R) 4100-06 (5 M)

Unterminated BP cable 4100-01 (7-pin DIN, one end only)

Witt Biomedical 4100-11 (6 F) 2199474

BCI International 4100-09 (6 M) 2392213

2392213

2199513

2392213

2199421

2199393

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Operators Manual

1-24 2-1

Chapter 2

Operation

Contents Page

Introduction ................................................................................. 2-3

Size Adjustments ......................................................................... 2-3

Calibration ................................................................................... 2-5

Heart Rate Adjustment ................................................................ 2-6

Artifact Simulation ...................................................................... 2-7

Respiration................................................................................... 2-8

Defibrillation Training................................................................. 2-9

Blood Pressure Simulation........................................................... 2-11

Personality Modules (Optional Special Functions)...................... 2-12

Interactive IABP Personality Modules..................................... 2-16

Cardiac Output Personality Modules ....................................... 2-18

Blood Pressure Cables ................................................................. 2-19

Connector Interface Pin Definitions ............................................ 2-21

DataSim 6100

Operators Manual

2-2

Operation Introduction

Introduction

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

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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)

(2) ART SYS/DIAS Mean (mmHg)

(3) PA SYS/DIAS Mean (mmHg)

(4) RA Mean (mmHg)

(5) AUX (CO)

(6) RESP (RA-LA) (Ω)

-3 -2 -1 STD +1 +2 +3 +4

.25 .50 .75 1 mV 1.25 1.50 1.75 2.0

116/62

123/66

14/6 9 21/9

2 4 6 8 10 12 14 16

.25 .50 .75 1.0 1.25 1.50 1.75 2.0

130/70

27/12

137/73

33/15

Not Adjustable

143/76

100

41/19

27/\

150/80

105

48/22

157/84

110

55/25

164/88

115

61/28

2-4

Operation Calibration

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

-4 30

-3 40 0.25 0.25

-2 50 0.50 0.50

-1 60 0.75 0.75

STD 70 1 1

+1 80 1.25 1.25

+2 90 1.5 1.5

+3 100 1.75 1.75

+4 121 2.0 2.0

+5 142 2.5 2.5

+6 163

+7 183

(78) HR CAL

(BPM)

(82) ECG/SIZE/CAL

Function

(mV)

(84) RESP SIZE

CAL (Ω)

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Operators Manual

Table 2-3. Calibration Functions (cont.)

Adjusment

Levels

+8 203

+9 227

+10 250

+11 268

+12 300

(78) HR CAL

(BPM)

To adjust calibration levels:

(82) ECG/SIZE/CAL

Function

(mV)

(84) RESP SIZE

CAL (Ω)

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:

ECG RATE

followed by the prompt:

], [ 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

Operation Artifact Simulation

Table 2-4. Heart Rates Obtained via Rate Adjust Special Function

RHYTHM -40% -30% -20% -10% STD +10% +20% +30%

Bradycardia 21 24 28 31 35 38 42 45

Ventricular 21 24 28 31 35 38 42 45

Junctional 24 28 32 36 40 44 48 52

Normal Sinus

Sinus Tach 84 98 112 126 140 154 168 182

Atrial Tach 90 105 120 135 150 165 180 195

Atrial Fib 60 70 80 90 100 110 120 130

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:

42 49 56 63 70 77 84 91

Note

RATE

followed by the prompt:

], [ 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 49.

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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:

60 CYCLE

followed by the prompt:

], [ 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 +1 +2 +3

47 ECG 60 Hz 0 .1 .4 .7 mV

48 ECG RESP 0 .4 .6 1.0 mV

49 ECG MUSCLE 0 .4 .6 1.0 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

Operation Defibrillation Training

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

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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

Operation Blood Pressure Simulation

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.

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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 2-6.

2-12

Operation Personality Modules (Optional Special Functions)

Table 2-6. Personality Modules

MDE Ref # Part # Description Additional Detail

6070-01B

6070-03B 2244432 Pediatric ECG Sinus Arrhythmia

6070-05B 2244444 Intra-Cranial

6070-06B 2244459 Advanced Pacer Undersensing

2244426

Intra-Aortic Balloon Assist (manual IABP waveform selection)

Pressures (ICP)

Early Inflation Late Inflation Early Deflation Late Deflation Proper Timing

Junctional Junctional Escape Wandering Pacer Hyperkalemia Enlarged Atrium CPR Artifact Sinus Tachycardia

Normal ICP Normal with Resp Artifact Damped with Resp Artifact Cough Artifact Hypercapnia B Wave and A Wave Jugular Comp

Oversensing Muscle Artifact Oversensing tall T Waves Fusion Pseudo Fusion Runaway Pacer PAC with DVI Pacer Retrograde VA Conduction

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DataSim 6100

Operators Manual

Table 2-6. Personality Modules (cont.)

MDE Ref # Part # Description Additional Detail

6070-07B 2244467 MCL1 Atrials Normal Sinus Rhythm

Bradycardia Sinus Arrest Atrial Tach Atrial Flutter Atrial Fib PAC PAT

6070-08B 2244471 MCL1 Blocks Normal Sinus Rhythm

degree AV block

degree AV block Type I

2nd degree AV block Type II

degree AV block RBBB LBBB

6070-09B 2244480 MCL1 Ectopy/

Aberrancy

Normal Sinus Rhythm Right PVC Left PVC Multifocal PVC’s R on T Bigeminy Atrial Fib with Aberrancy Cardiac Failure Sequence

6070-11B 224448 Left Heart

Pressures

Pressure Zero Normal AO, LV, LA AO to LV Insertion LV to AO Pullback AO, LV, and LA with PVCs

6070-12B 2244500 Valve Disease Mitral Stenosis

Mitral Regurgitation Aortic Stenosis Aortic Regurgitation LV/AO Pullback with AS LV/AO Pullback with AR

6070-13B 2244517 12-Lead Set Includes three previous

modules

6070-14B 2244521 12-Lead Normal

ECG

2-14

Operation Personality Modules (Optional Special Functions)

Table 2-6. Personality Modules (cont.)

MDE Ref # Part # Description Additional Detail

6070-15B 2244539 12-Lead Anterior

infarct

6070-16B 2244542 12-Lead Inferior

infarct

6070-17B 2244556 ST Segments 2.5 mm Horizontal ST

6070-10B 2244563 MCL1 Set (07,

08, 09)

6070-18B 2244588 Cardiac Output

(CO)(Injectate Temp = 0 °C)

6070-19B 2244595 Marquette CO

Module

6070-20B 2244602 Cardiac Output

(Injectate Temp = 25 °C)

Leads I, II, III, AVR, AVL, AVF, V1

Depression

2.5 mm Horizontal ST Elevation ST Downslope Depression ST Upslope Elevation ST Upslope Depression 45° ST Upslope Depression 30° ST Upslope Depression 20°

Includes 6070-07, 6070-08 and 6070-09

Injectate temp for use with 6070-23

Injectate temp for use with 6070-22

6070-24B 2244640 Defib Training

Module

6070-25B 2244657 Interactive

IABP/Kontron (K2000 and KAAT)

6070-26B 2244669 Interactive

IABP/Datasco pe

(7, 10, K2000, KAAT )

System 80

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DataSim 6100

Operators Manual

Table 2-6. Personality Modules (cont.)

MDE Ref # Part # Description Additional Detail

6070-29B 2244678 Interactive

IABP/Datascope

6070-30B 2244684 Interactive

IABP/Aries

6070-37B 2244706 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

Operation Personality Modules (Optional Special Functions)

• Datascope 90: connect cable (Fluke part #2199439, GE

3100/Datascope 6F cable) from the Datascope Pressure Transducer input connector to the Simulator ART connector.

• Datascope 80: cable (Fluke part #2199439, GE 3100/Datascope 6F

cable) from the Datascope ART PRES input connector to the Simulator ART connector.

• Kontron 7, 10, 2000, KAAT: connect cable (Fluke part #2199611,

Kontron High Level cable) from the KONTRON AUX input connector to the Simulator ART connector (Kontron 2000 ART input)

• Aries: cable (Fluke part #2199442, 4100-9 Space Labs 6M cable)

from the ARIES ART PRES input connector to the Simulator ART connector.

6. Zero the arterial pressure channel on the pump. To simulate atmospheric

pressure, select SPEC FUNC 62 (0mmHg). Use the module suggested procedure to obtain a 0 mmHg pressure reading.

7. When zeroed, select any cardiac rhythm to bring the arterial waveform on

the screen.

8. Connect the following IABP cable assemblies to the Simulator AUX

connector:

• Datascope 90: #2199597 from the DATA COM output connector

• Datascope 80: #2199585 from the System INTERFACE output

connector

• Kontron: #2199609 from the ASSIST INTERVAL output connector

• Aries: #2199609 from the ASSIST INTERVAL output connector.

9. Power on the balloon pump and follow normal procedures for initializing

the pump. Select a 2 to 1 assist ratio.

The Simulator responds to the balloon pump’s inflation/deflation signal with the appropriate augmented arterial pressure waveform.

10. Change ECG rhythms using the Simulator keypad.

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Operators Manual

Cardiac Output Personality Modules

The Simulator can be used with either of two Cardiac Output (CO) Personality Modules. 0 °C injectate temperature (model 6070-18) and 25 °C injectate temperature (model 6070-20) both simulate the Edwards style blood temperature catheter in generating several dilution curves.

The dilution curve at 0 °C injectate temperature assumes the following conditions:

• 10 cc Injectate volume

• Edwards 93-131-7F Catheter

• Injectate Bath Probe, 90.22 k Ω (compatible with Switchcraft connector

SL-40-47F)

• Computation Coefficient .542 *

The dilution curve at 25 °C injectate temperature assumes the following conditions:

• 10 cc Injectate volume

• Edwards 93-131-7F Catheter

• Injectate Bath Probe 62.34 k Ω (compatible with Switchcraft connector

SL-40-47F)

• Computation Coefficient .595 *

* Note

The use of other computation LM10 coefficients could result in CO values other than specified.

To use the Cardiac Output Module:

1. Insert the Cardiac Output Module into the Simulator Personality Module connector.

2. Power on the Simulator.

3. Connect the CO computer BT (blood temperature) cable to the CO Module’s 3-pin connector. (The BT cable in the clinical setting is attached to the thermistor on the Swan-Ganz catheter.)

4. Connect the CO computer injectate temperature cable to the black injectate temperature box that simulates 0 °C or 25 °C temperature. *

2-18

Operation Blood Pressure Cables

5. Set up the CO computer in accordance with the manufacturer instructions.

When ready to inject, select SPEC FUNC and the appropriate number for the desired CO curve listed on the module.

* Note

The internal resistor value is selected to meet the input requirements of the American Edwards or SpaceLabs bath probe injectate temperature. Fluke suggests using the actual bath probe and bath to meet the input requirements for other desired cardiac output computer systems or modules. Some patient monitoring systems default to an iced injectate (0 °C) if no bath probe is attached to the system.

Blood Pressure Cables

To ensure proper operation, the interface cables used between Simulator pressure outputs and the equipment must include the proper connectors and wiring. For the appropriate cables, refer to Table 2-7.

Table 2-7. Appropriate Pressure Simulator Interface Cables

Model Item Model Item

4100-01 Unterminated 4100-14 Abbott (7m)

4100-02 HP 5 µV (5F) 4100-15 Gould/Care (5M)

4100-03 HP 40 µV (5F) 4100-18 Litton (4M)

4100-04 HP 5 µV (12M) 4100-19 Siemens (10M)

4100-05 HP 40 µV (12M) 4100-20 Kontron/Rouche (6M)

4100-06 Spacelabs (5M) (700,

Alpha 9, 14)

4100-08 GE 3100/Datascope

(6F)

2-19

4100-23 Marquette (8M)

4100-24 Burdick DataSim

DataSim 6100

Operators Manual

Table 2-7. Appropriate Pressure Simulator Interface Cables (cont.)

Model Item Model Item

4100-09

Spacelabs

4100-25 Nihon/Kohden (5M)

(400,500,600,PC)

Physiocontrol (6M) 4100-37 Honeywell/Meddars (9M)

MDE Escort (6M) 4100-40 Fukuda Denshi (8M)

Mennen (6M) 4100-42 Siemens Mingo 7 (15M)

IVY (6M)

4100-11 EforM/Honeywell (6F) 4100-50 Armstrong High Level Output

4100-12 BD/Datamedix/Ohio

4100-60 Marquette Eagle Series

(9M)

4100-61 Fukuda Denshi (12M)

Figures 2-1 and 2-2 show the proper wiring for cables connecting channels 2 through 4 to most pressure monitors. For assistance in wiring pressure cables, contact the Fluke Biomedical Service Center.

Note

A special interface cable is not necessary for either ECG of respiration, because the Simulator ECG snap outputs are directly compatible with most standard patient cable lead wires.

150 Ω 1%

White

Black

Pair

White

Figure 2-1. Pressure Cable Wiring for Monitor with 5 µV/V mmHg

Sensitivity

2-20

GND Ref

+ SIG

- SIG

+ EXC

fdg003.eps

Operation Connector Interface Pin Definitions

Ref Pin 4

150 Ω 1%

Pin 2

GND Pin 6

C Pin 5

Figure 2-2. Pressure Cable Wiring for Monitor with 40 µV/V mmHg

Sensitivity

White

Black

Pair

White

GND Ref

+ SIG

- SIG

+ EXC

Note

To minimize noise, the +/- SIG wires should be a twisted pair, as should the +/- EXC wires

Connector Interface Pin Definitions

Table 2-8 contains definitions for ECG cable connector interface pins. Table 2-9 contains definitions for pressure cable connector interface pins. Figure 2-3 shows plug connector pin assignments.

Table 2-8. ECG Connectors

fdg004.eps

Pin #* Function

1 N/C

2 N/C

3 High Level Out

4 +9 V

5 Defib In

6 GND

7 Pacer Flag (5V, 10 msec)

2-21

DataSim 6100

Operators Manual

Table 2-9. Pressure Connectors

Pin #* Function

1 +Signal Out (5 µV/V mmHg)

2 + Signal Out (40 µV/V mmHg)

3 + High Level Out

4 EXC REF

5 + Excitation in

6 - Signal

7 +Signal Out (5 µV/V mmHg)

* Cable connectors #2710-0278 or Switchcraft #15 GM/7M

2-22

Figure 2-3. Connector Pin Assignments

fdg005.eps

Chapter 3

Maintenance, Service, and

Calibration

Contents Page

Maintenance................................................................................. 3-3

Avoiding Damage .................................................................... 3-3

Cleaning ................................................................................... 3-3

Battery Charging and Replacement ............................................. 3-4

Service and Calibration................................................................ 3-5

3-1

DataSim 6100

Operators Manual

3-2

Maintenance, Service, and Calibration Maintenance

Maintenance

The Simulator requires little maintenance or special care; however, it is a calibrated measuring instrument and should be treated as such. The optional carry case is recommended for storage. It is further recommended that the storage environment be free from vibration.

Avoiding Damage

Do not drop the instrument or subject it to any mechanical abuse that could cause a shift in the calibrated settings.

W Caution

To avoid damage to the Simulator or adverse affects on its performance, do not expose the system to temperature extremes. Ambient operating temperatures should remain between 0 °C and 40 °C, with a relative humidity less than 80 %.

Cleaning

Clean the exterior of the Simulator occasionally with a cloth dampened with a mild detergent solution.

W Caution

To avoid damage to the Simulator or adverse affects on its performance, do not spray liquid directly on or immerse the unit.

Carefully wipe down the cables and inspect them for damage and deterioration of the insulation. Check the cable connections for integrity.

3-3

DataSim 6100

Operators Manual

Battery Charging and Replacement

The Simulator is powered by a 1.9 AH sealed lead acid rechargeable battery, which powers the unit for up to 20 hours. The integrated charger requires up to 14 hours to charge the battery if its charge is significantly depleted. A Low Bat message is displayed when the battery needs to be recharged.

To charge the battery, plug the Simulator’s battery charger into the unit and into an ac line power source.

W Caution

To avoid damage to the Simulator or adverse affects on its performance, the battery should never be discharged completely. Repeated complete discharging can result in damage to the battery. To avoid this situation:

• Recharge the battery every six months if the unit has

not been used.

• Immediately begin charging when the battery level is

low. A fully charged battery retains at least 95% of its charge for 7 days with the unit turned OFF. The maximum charge time to reach 95% battery capacity is approximately 10 hours.

• Allow only qualified service personnel to replace the

battery.

To replace the battery:

1. Power off and disconnect the unit from the ac line power

2. Remove the six front panel screws

3. Remove the front panel assembly exposing the battery

4. Detach the battery wires and remove the battery bracket

5. Replace with 1.9 AH 12 V sealed lead acid battery, Fluke part #2183521 or equivalent.

3-4

Maintenance, Service, and Calibration Service and Calibration

Service and Calibration

If the new Simulator fails to operate successfully or if it needs a recommended yearly calibration, contact the Fluke Biomedical Service Center immediately, as indicated under Warranty and Product Support.

W Caution

To avoid damage to the Simulator or adverse affects on its performance, allow only qualified technical personnel to service the Simulator.

Packing

If repairs or calibration are required, return the Simulator to the factory or the nearest service center.

1. Before returning the Simulator for factory service, contact Fluke

Biomedical Service Center for a required Return Authorization Number.

2. Provide the following information:

• The Simulator serial number

• The specific steps that reproduce your problem

• A daytime phone number

• Your name / company

• A fax number (if available)

3. Pack the instrument carefully, using the original shipping container and

packing materials supplied by Fluke Biomedical. If the original packing materials are not available, refer to Return Procedures for a list of preferred materials or contact Fluke Biomedical for replacement packing.

Note

Failure to pack the instrument properly could void the warranty.

3-5

DataSim 6100

Operators Manual

Shipping

1. Place the Return Authorization Number in a prominent place on the

outside of the packing box, and refer to the number in any correspondence with Fluke Biomedical Service.

2. Enclose your return address and Return Authorization Number.

3. Insure the unit for full retail value and ship to the nearest Fluke

Biomedical Service Center.

3-6

Fluke 6100 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Warranty and Product Support

Table of Contents

List of Tables

List of Figures

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

Avoiding Damage

Cleaning

Battery Charging and Replacement

Service and Calibration