Fluke ProSim 4 User Manual

ProSim™ 4

Vital Signs Simulator

PN FBC-0007
January 2011, Rev. 3, 2/15
© 2011-2015 Fluke Corporation. All rights reserved. Specifications are subject to change without notice.
All product names are trademarks of their respective companies.

Users Manual

Warranty and Product Support

Fluke Biomedical warrants this instrument against defects in materials and workmanship for one year from
the date of original purchase OR two years if at the end of your first year you send the instrument to a
Fluke Biomedical service center for calibration. You will be charged our customary fee for such calibration.
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.

7/07

Notices

All Rights Reserved

 Copyright 2015, 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] or call
1-800-850-4608 or 1-440-248-9300. In Europe, email [e-mail] or call [phone].

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.

Returns and Repairs

Return Procedure

All items being returned (including all warranty-claim shipments) must be sent freight-prepaid to our factory location. When
you return an instrument to Fluke Biomedical, we recommend using United Parcel Service, Federal Express, or Air Parcel
Post. We also recommend that you insure your shipment for its actual replacement cost. Fluke Biomedical will not be
responsible for lost shipments or instruments that are received in damaged condition due to improper packaging or
handling.

Use the original carton and packaging material for shipment. If they are not available, we recommend the following guide
for repackaging:

 Use a double–walled carton of sufficient strength for the weight being shipped.
 Use heavy paper or cardboard to protect all instrument surfaces. Use nonabrasive material around all

projecting parts.

 Use at least four inches of tightly packed, industry-approved, shock-absorbent material around the

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 1-440-498-2560.

Repair and calibration:

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

To ensure the accuracy of the Product is maintained at a high level, Fluke Biomedical recommends the product
be calibrated at least once every 12 months. Calibration must be done by qualified personnel. Contact your local
Fluke Biomedical representative for calibration.

instrument.

In the U.S.A.:
Cleveland Calibration Lab
Tel: [phone] x2564
Email: [e-mail]

Everett Calibration Lab
Tel: 1-888-99 FLUKE (1-888-993-5853)
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]

PN FBC-0007
January 2011, Rev. 3, 2/15
© 2011-2015 Fluke Corporation. All rights reserved. Specifications are subject to change without notice.
All product names are trademarks of their respective companies.

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 in­house 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 ProSim 4 is manufactured at Fluke Biomedical, 6920 Seaway Blvd., Everett, WA, U.S.A.

Table of Contents

Title Page

Introduction ............................................................................................ 1

Intended Use ......................................................................................... 1

Safety Information ................................................................................. 2

Symbols ................................................................................................. 3

Unpack the Product ............................................................................... 3

Accessories ........................................................................................... 4

Instrument Familiarization ..................................................................... 5

How to Turn On the Product .................................................................. 7

ECG Simulation ..................................................................................... 8

Arrhythmia Simulation ........................................................................... 10

How to Set an Arrhythmia ECG Waveform ....................................... 11

How to Output a Performance Wave ................................................. 11

Respiration Simulation .......................................................................... 11

Non-Invasive Blood Pressure Simulation and Tests ............................. 12

How to Set the Non-Invasive Blood Pressure Parameters ................ 12

How to Do an NIBP Monitor Test ...................................................... 14

How to Do a Pressure Relief Test ..................................................... 14

How to Do a Leak Test ...................................................................... 15

How to Check a Manometer .............................................................. 17

Invasive Blood Pressure Simulation ...................................................... 18

Autosequences ...................................................................................... 19

Setup Features ...................................................................................... 22

How to Set the Backlight Intensity Level ........................................... 22

How to Change the Language for the Display ................................... 23

How to Show Instrument Information in the Display .......................... 24

Maintenance .......................................................................................... 24

How to Clean the Product .................................................................. 25

Battery Maintenance .......................................................................... 25

How to Charge the Battery ............................................................ 26

Battery Removal ............................................................................ 27

General Specifications .......................................................................... 27

Detailed Specifications .......................................................................... 28

Normal-Sinus-Rhythm Waveform ...................................................... 28

Arrhythmia ......................................................................................... 28

ECG-Performance-Testing ................................................................ 29

Respiration ........................................................................................ 29

i

ProSim™ 4

Users Manual

Invasive Blood Pressure .................................................................... 29

Non-Invasive Blood Pressure ............................................................ 29

Presets and Autosequences .............................................................. 30

Glossary ............................................................................................................ A-1

ii

List of Tables

Table Title Page

1. Simulation Types ....................................................................................... 1

2. Symbols ..................................................................................................... 3

3. Standard Accessories ............................................................................... 4

4. Optional Accessories ................................................................................. 4

5. Product Controls and Connections ............................................................ 5

6. Display Features ....................................................................................... 6

7. Pre-Defined Patient Simulations ............................................................... 8

8. ECG Lead Amplitudes ............................................................................... 10

9. Autosequences .......................................................................................... 21

iii

ProSim™ 4

Users Manual

iv

List of Figures

Figure Title Page

1. Home Screen ............................................................................................ 7

2. ECG Connections ...................................................................................... 9

3. ECG Screen .............................................................................................. 9

4. Arrhythmia Screens ................................................................................... 10

5. Respiration Screen .................................................................................... 11

6. Non-Invasive Blood Pressure Test Connections ....................................... 12

7. Blood Pressure Cuff Mandrel Sizes .......................................................... 13

8. Non-Invasive Blood Pressure Screen ....................................................... 14

9. Pressure Relief Test Screen ..................................................................... 15

10. Leak Test Screen ...................................................................................... 16

11. Leak Test Results Screen ......................................................................... 17

12. Manometer Check Connections ................................................................ 17

13. Invasive Blood Pressure Connections ....................................................... 18

14. Invasive Blood Pressure Screen ............................................................... 18

15. Static Pressure Screen .............................................................................. 19

16. Monitor Testing Autosequence Screen ..................................................... 19

17. Monitor Testing Autosequence Steps Screen ........................................... 20

18. Setup Screen ............................................................................................. 22

19. Backlight Screen ....................................................................................... 22

20. Language Screen ...................................................................................... 23

21. Instrument Information Screen .................................................................. 24

22. External Battery Charging Connections .................................................... 26

23. Battery Removal ........................................................................................ 27

v

ProSim™ 4

Users Manual

vi 1

Introduction

The ProSim 4 Vital Signs Simulator (the Product) is a portable vital signs
monitor functional tester.

The product simulates:

• ECG Functions

• Respiration

• Invasive and non-invasive Blood Pressure

When the term simulation is used in connection with ECG, respiration, IBP, or
NIBP, the simulation type shown in Table 1 is used in this Product.

Table 1. Simulation Types

Parameter Simulation Type

ECG Electrical

Respiration Electrical

IBP Electrical

NIBP Pneumatic

Intended Use

The Product is intended to be used to test and verify the basic operation of
patient monitoring devices or systems used to monitor various physiological
parameters of a patient, including ECG, respiration, invasive blood pressure, and
non-invasive blood pressure.

The intended user is a trained biomedical equipment technician who performs
periodic preventative maintenance checks on patient monitors in service. Users
can be associated with Hospitals, clinics, original equipment manufacturers and
independent service companies that repair and service medical equipment. The
end user is an individual, trained in medical instrumentation technology.

This Product is intended to be used in the laboratory environment and is not
intended for use on patients, or to test devices while connected to patients. This
Product is not intended to be used to calibrate medical equipment. It is intended
for over the counter use.

ProSim™ 4

Users Manual

Safety Information

In this manual, 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.

 Warnings

To prevent personal injury, use the Product only as specified,
or the protection supplied by the Product can be compromised.

To prevent possible electrical shock, fire, or personal injury:

• Do not use and disable the Product if it is damaged.

• The battery door must be closed and locked before you

operate the Product.

• Remove all probes, test leads, and accessories that are not

necessary for the measurement.

• Do not use the Product around explosive gas, vapor, or in

damp or wet environments.

• Do not use the Product if it operates incorrectly.

• Do not connect the Product to a patient or equipment

connected to a patient. The Product is intended for
equipment evaluation only and should never be used in
diagnostics, treatment, or any other capacity where the
Product would come in contact with a patient.

• Read all safety Information before you use the Product.

• Examine the case before you use the Product. Look for

cracks or missing plastic. Carefully look at the insulation
around the terminals.

• Carefully read all instructions.

2

Vital Signs Simulator
Symbols

Symbols

Table 2 is a list of symbols found in this manual or on this Product.

Table 2. Symbols

Symbol Description Symbol Description



Risk of danger. Important information.
See manual.

 Conforms to European Union directives. 







Conforms to relevant Australian EMC
standards

Spent Lithium batteries should be disposed of by a qualified recycler or hazardous materials
handler per local regulations. Contact your authorized Fluke Service Center for recycling
information.

This product complies with the WEEE Directive (2002/96/EC)marking requirements. The affixed
label indicates that you must not discard this electrical/electronic product in domestic household
waste. Product Category: With reference to the equipment types in the WEEE Directive Annex
I, this product is classed as category 9 "Monitoring and Control Instrumentation" product. Do
not dispose of this product as unsorted municipal waste. Go to Fluke’s website for recycling
information.

Unpack the Product

Carefully unpack all items from the box and check that you have these items:

• ProSim 4

• Getting Started Manual

• Users Manual CD

• Carrying Case





Hazardous voltage. Risk of electric
shock.

Input jack for the DC output of the
AC/DC supply connector.

Conforms to relevant North American
Safety Standards.

• Power Cord

• AC/DC Power Supply

• Manual Inflation Bulb

• NIBP Cuff Adapters

3

ProSim™ 4

Users Manual

Accessories

Available Product accessories are shown in Tables 3 and 4.

Table 3. Standard Accessories

Item Fluke Biomedical Part Number

ProSim 4 Getting Started Manual 3931478

ProSim 4 Users Manual CD 3931519

AC/DC Power Supply 3978380

US 284174

Schuko 769422

AC Power Cord

Manual inflation bulb 2461946

Set of NIBP Cuff Adapters 2391882

Carrying Case 4026799

[1] Product shipped to Brazil also includes a US power cord.

Battery pack 4026823

USB Cable, Mini Series B, 1 meter long 4034393

NIBP Mandrel Set 4308086

Modules to convert ECG snap adapter to 4 mm and 3.2 mm
ECG banana adapter as part of optional accessories – For
International use only

UK 769455

Japan 284174

Australia 658641

[1]

Brazil

Item Fluke Biomedical Part Number

3841347

Table 4. Optional Accessories

4026551

4

IBP Cables See your Fluke Biomedical Distributor