Fluke ProSim 2 User Manual

ProSim™ 2/3

Vital Signs Simulator

Users Manual

FBC 0038

January 2013, Rev. 1

© 2013 Fluke Corporation. All rights reserved. Specifications are 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 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 2012, 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 instrument.

Returns for partial refund/credit:

Every product returned for refund/credit must be accompanied by a Return Material Authorization (RMA) number, obtained from our Order Entry Group at 1- 440-498-2560.

Repair and calibration:

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

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]

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.

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 ProSim™ 2/3 Vital Signs Simulator is manufactured at Fluke Biomedical, 6920 Seaway Blvd., Everett, WA, U.S.A.

Table of Contents

Title	Page
Introduction....................................................................................................................	1
Safety Information..........................................................................................................	1
Accessories ...................................................................................................................	4
Product Familiarization ..................................................................................................	5
Battery Eliminator ..........................................................................................................	8
How to Turn On the Product ..........................................................................................	8
Operation.......................................................................................................................	9
Cardiac Functions..........................................................................................................	10
ECG Functions..........................................................................................................	10
Pacemaker Signals ...................................................................................................	13
Arrhythmia Function..................................................................................................	13
ECG Tests ................................................................................................................	14
How to Set a Performance Wave Output .............................................................	14
R-Wave Detection Test ........................................................................................	14
Blood Pressure Function...........................................................................................	15
How to Set the BP Sensitivity...............................................................................	15
How to Set Up a BP Channel...............................................................................	15
Dynamic BP Waveforms ......................................................................................	15
How to Add a Respiration Artifact to the BP Waveform .......................................	17
Cardiac Output..........................................................................................................	17

i

ProSim™ 2/3

Users Manual

Cardiac-Output Test Set Up .................................................................................	17
How to Simulate Injectate Failure and Left-to-Right Shunt Fault..........................	19
How to Simulate Output from a Calibrated Pulse Signal ......................................	19
Fetal/Maternal Function ............................................................................................	21
Simulate Fixed Fetal Heart Rate (FHR)................................................................	21
How to Simulate a Periodic FHR with Intrauterine Pressure (IUP).......................	21
Other Functions .............................................................................................................	24
Respiration Functions ...............................................................................................	24
Temperature .............................................................................................................	24
Remote Operation .........................................................................................................	26
Remote Commands ..................................................................................................	27
General Commands ..................................................................................................	28
Function Commands .................................................................................................	28
ECG Functions.....................................................................................................	28
Arrhythmia Functions ...........................................................................................	31
ECG Test Functions .............................................................................................	32
Respiration Function Commands .........................................................................	35
Blood Pressure Function Commands...................................................................	36
Other Function Commands ..................................................................................	40
Maintenance ..................................................................................................................	41
General Maintenance................................................................................................	41
Battery Replacement.................................................................................................	42
General Specifications...................................................................................................	43
Detailed Specifications...................................................................................................	43
ECG Waveform.........................................................................................................	43
Pacemaker Waveform...............................................................................................	44
Arrhythmia.................................................................................................................	44
ECG-Performance-Tests...........................................................................................	45
Respiration................................................................................................................	45
Blood Pressure .........................................................................................................	45
Temperature .............................................................................................................	47
Cardiac Output (ProSim 3 Only) ...............................................................................	47
Fetal / Maternal-ECG (ProSim 3 Only)......................................................................	47
Computer Setup........................................................................................................	48

ii

List of Tables

Table	Title	Page
1.	Symbols ................................................................................................................................	3
2.	Standard Accessories...........................................................................................................	4
3.	Optional Accessories ............................................................................................................	4
4.	Front-Panel Controls and Connectors ..................................................................................	6
5.	Top-Panel Connectors..........................................................................................................	7
6.	Product Functions.................................................................................................................	9
7.	Dynamic BP Waveforms by BP Channel ..............................................................................	16
8.	Error Codes ..........................................................................................................................	27
9.	Product Control States and Modes .......................................................................................	28
10.	General Commands..............................................................................................................	28
11.	ECG Function Commands ....................................................................................................	28
12.	Pacemaker Waveform Commands .......................................................................................	30
13.	Arrhythmia Function Commands ..........................................................................................	31
14.	ECG Test Commands...........................................................................................................	33
15.	Respiration Function Commands..........................................................................................	35
16.	Blood Pressure Function Commands ...................................................................................	37
17.	Other Function Commands...................................................................................................	40

iii

ProSim™ 2/3

Users Manual

iv

List of Figures

Figure	Title	Page
1.	Front-Panel Controls and Connectors ..................................................................................	5
2.	Top-Panel Connectors..........................................................................................................	7
3.	Battery Eliminator Connections.............................................................................................	8
4.	Power-Up Screen .................................................................................................................	8
5.	Home Screen........................................................................................................................	9
6.	Home Screen – Cardiac Function.........................................................................................	9
7.	Cardiac Output Screen .........................................................................................................	10
8.	ECG Screen..........................................................................................................................	11
9.	ECG Test Connections .........................................................................................................	12
10.	Arrhythmia Screen ................................................................................................................	13
11.	Cardiac Output Injectate CI-3 Adapter..................................................................................	18
12.	Cardiac Output Connections.................................................................................................	20
13.	Fetal/Maternal Connections ..................................................................................................	23
14.	Temperature Simulation Connections...................................................................................	25
15.	Remote Operation Connections............................................................................................	26
16.	Battery Replacement ............................................................................................................	42

v

ProSim™ 2/3

Users Manual

vi

Introduction

Warning

To prevent possible electrical shock, fire, or personal injury, read all safety information before you use the Product.

The ProSim™ 2 and ProSim™ 3 Vital Signs Simulators (the Product) are electronic signal sources used to measure the performance of patient monitors. The Product simulates:

•ECG (with and without arrhythmias)

•Respiration

•Blood pressure

•Temperature

•Cardiac output (ProSim 3 only)

•Fetal/Maternal ECG and IUP (ProSim 3 only)

The ProSim™ 3 is shown in all illustrations.

Safety Information

A Warning identifies conditions and procedures that are dangerous to the user. A Caution identifies conditions and procedures that can cause damage to the Product or the equipment under test.

Table 1 is a list of symbols used on the Product and in this manual.

Warning

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

•Use the Product only as specified, or the protection supplied by the Product can be compromised.

•Do not connect the Product to a patient or equipment connected to a patient. The Product is intended for equipment analysis only. Do not use the Product for diagnostics, treatment, or other capacity where the Product touches a patient.

•Remove the batteries if the Product is not used for an extended period of time, or if stored in temperatures above 50 °C. If the batteries are not removed, battery leakage can damage the Product.

•Replace the batteries when the low battery indicator shows to prevent incorrect measurements.

1

ProSim™ 2/3

Users Manual

•Carefully read all instructions.

•Do not use the Product around explosive gas, vapor, or in damp or wet environments.

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

•Do not use the Product if it operates incorrectly.

•Examine the case before you use the Product. Look for cracks or missing plastic. Carefully look at the insulation around the terminals.

•Read all safety information before you use the Product.

•Remove all probes, test leads, and accessories before the battery door is opened.

•Remove all probes, test leads, and accessories that are not necessary for the measurement.

•Batteries contain hazardous chemicals that can cause burns or explode. If exposure to chemicals occurs, clean with water and get medical aid.

2

				Vital Signs Simulator
				Safety Information
		Table 1. Symbols
	Symbol	Description	Symbol	Description
		Important information. Refer to manual.		Hazardous Voltage
		Conforms to European Union directives		Conforms to relevant North American Safety
				Standards.
		Conforms to relevant Australian EMC		Battery
		requirements
				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
		Conforms to relevant South Korean EMC		domestic household waste. Product Category:
				With reference to the equipment types in the
		Standards
				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.

3

ProSim™ 2/3

Users Manual

Accessories

Available Product Accessories are shown in Tables 2 and 3.

		Table 2. Standard Accessories
		Item		Fluke Biomedical Part Number
	ProSim 2/3 Safety Information		4308669
	ProSim 2/3 Users Manual CD		4253822
	IBP Cable, Unterminated		2392173
	ProSim 2/3 Carrying Case		2248623
	CI-3 Cable Assembly (Cardiac Output Box), 3010-0289FG		2392199
	USB Mini-B Cable		1671807
		Table 3. Optional Accessories
		Item		Fluke Biomedical Part Number
	Temperature Cable	YSI 400 Series (UT-4)	2523334
		YSI 700 (UT-2)	2199019
	Cardiac Output Marq Eagle (Cardiac output switch for GE)		4022300
	AC/DC Power Supply Set		4318692

4

Vital Signs Simulator

Product Familiarization

Product Familiarization

Table 4 is a list of controls and connectors on the Product shown in Figure 1.

1

8

7

6

2

3

4

5

hal001.eps

Figure 1. Front-Panel Controls and Connectors

5

ProSim™ 2/3

Users Manual

		Table 4. Front-Panel Controls and Connectors
Item	Name	Description
	Display	LCD Display
	Navigation buttons	Cursor control buttons for navigating menus and lists.
	Enter button	Sets the highlighted function.
	Power button	Turns on and off the Product.
	DC Power Connector	Connector for the AC/DC power supply.
	Cardiac Output Connector	Connector to the Cardiac input of the patient monitor.
	Invasive Blood Pressure	Four connectors to the Invasive Blood Pressure (IBP) input of the patient monitor.
	Connectors
	Temperature Connector	Connector to the Temperature input of the patient monitor.

6