Fluke 6100 User Manual

DataSim 6100

Patient Simulator

Operators Manual

PN 2242959
February 2008

© 2008 Fluke Corporation, All rights reserved. Printed in USA. Specifications subject to change without notice.
All product names are trademarks of their respective companies.

Warranty and Product Support

Fluke Biomedical warrants this instrument against defects in materials and
workmanship for one 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

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 email

[e-mail]

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: [phone]
Email: [e-mail]

Everett Calibration Lab
Tel: [phone]
Email: [e-mail]

In Europe, Middle East, and Africa:
Eindhoven Calibration Lab
Tel: [phone]
Email: [e-mail]

In Asia:
Everett Calibration Lab
Tel: [phone]
Email: [e-mail]

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.

Table of Contents

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

i

DataSim 6100

Operators Manual

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

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

ii

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

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DataSim 6100

Operators Manual

iv

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

v

DataSim 6100

Operators Manual

vi

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

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

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

1

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

10

DataSim 6100

Patient Simulator

NSR1TACH2BRAD3ASYS

0

A-FLTR5A-FIB62AVB172AVB2

4

3AVB9PAC

V-TAC

PVC1 PVC2

SPEC

V-FIB

STD

FUNC

8

CPLT

KEYPAD

POWER

ECG

ART

PA

RA

On
Off

LL (+)

LA (-)

RA

RL

V1

V2

V3

V4

V5

(-)

3

4

9

AUX

V6

PERSONALITY

8

MODULE

MANKIN

SIMULATE

DEFIB

5

6

1-6

7

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

1

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.

1-7

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

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