Fluke BP Pump 2 User Manual

BP Pump 2

NIBP Simulator and Tester

Operators Manual

PN 2196592

June 2007

© 2007 Fluke Corporation, All rights reserved. Printed in USA

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 de- cision-maker of competent jurisdiction, such holding will not affect the validity or enforceability of any other provision.

07/07

Notices

All Rights Reserved

♥ Copyright 2007, 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- 648-7952 or 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.

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 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 1-800-648-7952 or 1-425-446- 6945.

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]

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]

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 BP Pump 2 Non-invasive Blood Pressure Simulator and Tester 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
	Key Features .........................................................................................		1-3
	General Safety Considerations..............................................................		1-4
	Symbols ............................................................................................		1-4
	Warnings and Cautions.....................................................................		1-5
	Instrument Familiarity ..........................................................................		1-7
	Powering Up the Tester ........................................................................		1-10
	Specifications........................................................................................		1-10
	Accessories ...........................................................................................		1-12
2	Setup, Maintenance, and Support...........................................		2-1
	Setting up the Tester .............................................................................		2-3
	Printer Output ...................................................................................		2-4
	User-Defined Simulations.................................................................		2-5
	Language ..........................................................................................		2-6
	Units of Measure...............................................................................		2-6
	Self Test............................................................................................		2-8
	Zero Pressure ....................................................................................		2-8
	Enable ECG Signal ...........................................................................		2-9
	Maintenance and Support .....................................................................		2-10
	Avoiding Damage .............................................................................		2-10
	Cleaning............................................................................................		2-10
	Service and Calibration.....................................................................		2-11
	Packing Instructions..........................................................................		2-11
3	Operation ..................................................................................		3-1
	Introduction ..........................................................................................		3-3
	Configurations for Devices Under Test (DUT).................................		3-4
	Conversion Factors ...........................................................................		3-7
	Initializing Tests and Simulations.....................................................		3-7
	Error Messages .................................................................................		3-7

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Pressure Tests.......................................................................................		3-8
	Pressure Leak Test............................................................................	3-8
	Pressure Relief Test..........................................................................	3-10
	Pressure Source Test ........................................................................	3-11
	Pressure Gauge Test .........................................................................	3-12
Simulations...........................................................................................		3-13
	Standard BP......................................................................................	3-14
	Patient Conditions ............................................................................	3-15
	Arrhythmias......................................................................................	3-16
	Respiratory Artifacts ........................................................................	3-18
	Neonate ............................................................................................	3-19
	Wrist.................................................................................................	3-20
	User-Defined ....................................................................................	3-21
Auto Sequences....................................................................................		3-21
	Editing Auto Sequences ...................................................................	3-22
	Printing Auto Sequences ..................................................................	3-23
	Running Auto Sequences .................................................................	3-24
	Pressure Gauge.............................................................................	3-25
	Leak Test......................................................................................	3-25
	Relief Valve Test..........................................................................	3-26
	Pressure Source ............................................................................	3-26
	Data Sheet Printout.......................................................................	3-27
	BP Simulations.............................................................................	3-27
Remote Operation ................................................................................		3-29
	RS-232 Settings................................................................................	3-29
	Ansur Software Control....................................................................	3-29
Appendices
A	ECG Interface...............................................................................	A-1
B	Questions and Answers ................................................................	B-1
C	Abbreviations ...............................................................................	C-1
D	Computer Control Commands......................................................	D-1

ii

List of Tables

Table	Title	Page
1-1.	Symbols ................................................................................................	1-4
1-2. Top and Side Panel Components ..........................................................		1-8
1-3.	Number Key Functions.........................................................................	1-9
1-4.	Standard Accessories ............................................................................	1-12
1-5.	Optional Accessories ............................................................................	1-12
3-1.	Conversion Factors ...............................................................................	3-7
3-2. Standard Blood Pressure Simulations ...................................................		3-15
3-3.	Patient Condition Simulations ..............................................................	3-16
3-4.	Arrhythmia Simulations........................................................................	3-17
3-5.	Respiratory Artifact Simulations ..........................................................	3-18
3-6.	Neonate Simulations .............................................................................	3-19
3-7.	Wrist Simulations .................................................................................	3-20
D-1. Computer Control Commands ..............................................................		D-1

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iv

List of Figures

Figure	Title	Page
1-1. Tester Top and Side Panel Components ...............................................		1-7
3-1.	Tester Pneumatic Block Diagram .........................................................	3-3
3-2.	Connecting Tester to Single-hose NIBP Monitor (Int Cuff) .................	3-4
3-3.	Connecting Tester to Double-hose NIBP Monitor (Int Cuff)................	3-5
3-4.	Connecting Tester to Single-hose NIBP Monitor (Ext Cuff) ................	3-5
3-5. Connecting Tester to Double-hose NIBP Monitor (Ext Cuff)...............		3-6
3-6.	Connecting Tester to Single-hose NIBP Wrist Monitor (Ext Cuff) ......	3-6
3-7.	Sample Auto Sequence Test Printout....................................................	3-24
3-8.	Sample Data Sheet Printout ..................................................................	3-28
A-1.	Optional ECG Interface Adapter...........................................................	A-1

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vi

Chapter 1

Introduction and Specifications

Contents	Page
Introduction ..................................................................................	1-3
Key Features.................................................................................	1-3
General Safety Considerations .....................................................	1-4
Symbols ....................................................................................	1-4
Warnings and Cautions.............................................................	1-5
Instrument Familiarity..................................................................	1-7
Powering Up the Tester................................................................	1-10
Specifications ...............................................................................	1-10
Accessories...................................................................................	1-12

1-1

BP Pump 2

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1-2

Introduction and Specifications 1

Introduction

Introduction

The Fluke Biomedical BP Pump 2 Non-Invasive Blood Pressure Simulator and Tester, hereafter known as the “Tester”, is a multi-purpose test instrument for use with oscillometric Non-Invasive Blood Pressure Monitors (NIBPMs). The Tester provides dynamic blood pressure simulations, static calibration, automated leak testing, and pressure relief valve testing. The following models are available:

•BP Pump 2L (Basic Model)

•BP Pump 2M (High-Accuracy Model)

The Tester allows you to verify the performance claims of different blood pressure monitors. You can quickly recall the fixed onboard simulations or define your own. With its internal pump, the Tester can generate pressures up to 400 mmHg (53.3 kPa) for leak testing, pressure sourcing, and relief valve testing.

In addition, you can define auto sequences that automate the sequencing of tests and NIBP simulations and provide an optional printed report.

Key Features

Key features of the Tester include:

•Pressure leak testing on cuff, tubing, and connections

•Relief valve testing on the patient monitor

•Pressure gauge measurements

•Pressure source capability

•NIBP simulations including adult, neonate, arrhythmias, and respiratory artifacts

•Auto sequences with optional reports

•Internal Adult and Neonatal Cuff simulation

Tester capabilities can be extended with optional accessories that allow:

•ECG synchronization with non-invasive output

•External wrist cuff simulations

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Tester pressure accuracy can be improved by upgrading to a high-accuracy pressure transducer. This is a factory service upgrade and is provided to customers wanting to meet the DIN EN 1060 requirements for pressure measurement accuracy. For more information, refer to “Setup, Maintenance, and Support: Maintenance and Support.”

General Safety Considerations

This Tester complies with safety and technical requirements described in the following directives:

•UL 3101-1, Electrical Equipment for Laboratory Use; Part 1: General Requirements.

•CAN/CSA C22.2 No. 1010.1 (1992), Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use, Part 1: General Requirements.

•EC 73/23/EEC (Amended 93/68/EEC) EN61010-1:2001, Safety requirement for electrical equipment for measurement, control and laboratory use, Part 1: General Requirements.

Symbols

Table 1-1 describes symbols used in association with the Tester.

Table 1-1. Symbols

	Symbol	Description	Symbol	Description
	W	Risk of danger. Important	X	Hazardous voltage. Risk
		information. See manual.		of electrical shock.
		Intertek Electrical Test
	Œ	Laboratory listed.	P	Conforms to European
		Conforms to relevant
				Union directives
		Canadian and U.S.
		standards.
		Do not dispose of this
	~	product as unsorted
		municipal waste. Contact
		Fluke or a qualified
		recycler for disposal.

1-4

Introduction and Specifications 1

General Safety Considerations

Warnings and Cautions

Users are advised to read the manual carefully, observing all warnings and cautions, before attempting to set up and operate the Tester.

A Warning identifies hazardous conditions and actions that could cause bodily harm or death.

A Caution identifies conditions and actions that could damage the Tester or the equipment under test, or cause permanent loss of data.

W X Warning

To avoid possible electric shock or personal injury, follow these guidelines:

•Read the Users Manual before operating the Tester.

•Use this Tester only in the manner specified by the manufacturer or the protection provided may be impaired.

•Do not connect the Tester to a patient or equipment connected to a patient. The Tester is intended for equipment evaluation only and should never be used in diagnostics, treatment or in any other capacity where the Tester would come in contact with a patient.

•Do not use the product in wet locations, around explosive gases or dust.

•Never open the Tester case, because dangerous voltages are present. There are no user replaceable parts in the Tester.

•The Tester must be properly earthed. Only use a supply socket that has a protective earth contact. If there is any doubt as to the effectiveness of the supply socket earth, do not connect the Tester.

•Do not use a two-conductor adapter or extension cord; this will break the protective ground connection.

•Ensure that the external power source is properly rated for the system.

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•Always connect the system power cord directly to a three-prong receptacle with a functional ground. Never use a two-prong plug adapter to connect primary power to the Tester, thereby disconnecting the utility ground.

•Disconnect the Tester from the power source before changing the supply voltage. The Tester operates at a range of 100 to 240 volts.

W Caution

To avoid damage to the Tester or adverse affects on its performance, follow these guidelines:

•Allow only qualified technical personnel to service the Tester.

•Do not expose the system to temperature extremes. Ambient temperatures should remain between 15° C and 40° C. System performance may be adversely affected if temperatures fluctuate above or below this range.

•Clean the Tester only by gently wiping down with a clean, lint-free cloth dampened with a mild detergent solution. Do not immerse the unit.

•Do not apply pressures greater than 400 mmHg (53 kPa) to the pressure port.

1-6

Introduction and Specifications 1

Instrument Familiarity

Instrument Familiarity

Figure 1-1 shows the Tester. The top and side panel components are described in Table 1-2 and the number key functions are described in Table 1-3.

1

2

3

BP

4

5

NO

N-I

NVPump

2

ASI

VE

BLOOD

PRESSURE

MON

ITOR

AN

AL

YZER

PRESSURELEAK

TESTS

AND

STANDARD

1

SIMULA

BP

4

RELIEFPRESSURE

TIONS

RESPIRI

PA

2

ARTIF

7

ACTORY

TIENT

TA

T

CONDITIONS5

TIC

PRESSURE

NEONA

ARRHYTHMIAS6

3

8

TE

ENT

USER

0 DEFINED

WRIST

9

PRESSURE

PO

RT

6

7

8

9

fas10.eps

Figure 1-1. Tester Top and Side Panel Components

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Table 1-2. Top and Side Panel Components

	Label	Name	Function
	A	Home Key	Returns the operator to the Main Menu.
	B	Soft Keys 1 - 4	Makes dynamic assignments based on
			the current screen.
		Number (Test and	Allows the operator to perform auto
	C		sequences and simulations using
		Simulations) Keys
			numeric keys.
	D	Enter Key	Advances to the next menu or
			saves/selects options.
			LED blinks in synchronization with
	E	Pulse Indicator	beeper, indicating that the pump is
			generating a simulated blood pressure
			pulse.
	F	ECG Interface Port	Allows connection of optional ECG
			accessory (refer to Appendix, ECG
			Option).
	G	Printer Port	Provides D-25 female connector for
			external parallel printer.
	H	RS-232 Serial Port	Provides serial D-9 female connector for
			bi-directional computer control.
			Connects to the Non-Invasive Blood
	I	Pressure Port	Pressure Monitor for all pressure
			simulations and tests.

1-8

		Introduction and Specifications	1
		Instrument Familiarity
	Table 1-3. Number Key Functions
Number	Name	Function
		Pressurizes a pneumatic system to an
	PRESSURE	operator-defined target pressure up to
1		400 mmHg (53.3 kPa) and then
	LEAK
		measures the loss of pressure over
		time.
		Increases the pressure in the
	PRESSURE	pneumatic system until the relief valve
2		on the NIBP monitor opens or until the
	RELIEF
		Setpoint is reached, whichever occurs
		first.
		Accessed via the Pressure Gauge
	STATIC	Test, which enables the Tester to
3		measure static pressure generated by
	PRESSURE
		an external source in the range of 50
		to 400 mmHg 6.7 to 53.3 kPa).
		Provides seven variations of NIBP
4	STANDARD BP	simulations for both arm and wrist
		cuffs.
	PATIENT	Includes simulations for healthy,
5		geriatric, and obese patients, a well as
	CONDITIONS
		various levels of exercise.
		Measures erratic heart rhythms,
6	ARRHYTHMIAS	including atrial fibrillation and
		premature ventricular contraction.
	RESPIRATORY	Exhibits a beat-to-beat variation in the
7		blood pressure caused by intrathoracic
	ARTIFACT
		pressure.
		Tests the ability of the NIBP monitors
8	NEONATE	to detect blood pressure on neonatal
		patients.
9	WRIST	Tests wrist cuff NIBP monitors.
0	USER DEFINED	Allows the operator to define blood
		pressure simulations.

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Powering Up the Tester

The Tester is very simple to power up. Follow these steps:

1.Plug in a three-pronged power cord to the back of the unit.

2.Plug the cord into an appropriate socket, ensuring that the external power source is properly rated for the system.

3.Move the power switch above the plug to the on position. After two momentary screens, the Tester displays the Main menu, from which all Tester functions are selected.

Fluke Biomedical BP Bump 2
PERFORM	PRESSURE	AUTO
SIMULATION	TESTS	SEQUENCE	SETUP

fas31.eps

Specifications

The following are specifications for the Tester. Please contact your Fluke Biomedical service representative for more information regarding the device specifications.

Mains Voltage

Range......................................................................100 - 240 V ac 50/60 Hz, 60 VA

Environmental Conditions

Operating Temperature	...........................................15 °C to 40 °C
Storage Temperature ..............................................	-20 °C to +65 °C
Relative Humidity ....................................................	90 % max

Pressure Measurement

Units	........................................................................kPa
	mmHg
	cmH2O
	inH2O
	psi

1-10

Introduction and Specifications
	Specifications	1
Range .....................................................................	0 mmHg to +400 mmHg
Resolution...............................................................	0.1 kPa
	1 mmHg
	1 cmH2O
	1 inH2O
	0.1 psi
Resolution (High Accuracy Version) .......................	0.01 kPa
	0.1 mmHg
	0.1 cmH2O
	0.1 inH2O
	0.01 psi
Accuracy (Standard Version)
0 to 300 mmHg ...................................................	±0.5 % of reading ±1 mmHg
301 to 400 mmHg ..............................................	±2 % of reading
High-Accuracy Version ...........................................	<0.8 mmHg (0.1 kPa)
Pressure Generation
Pressure Generator, Static Pressure Range ..........	50 mmHg to +400 mmHg
Difference between target pressure
and actual pressure ................................................	±10 mmHg from 100-400 mmHg with
	a minimum volume of 300 cc
Internal Leak Rate ..................................................	<2 mmHg per minute, with a minimum
	volume of 300 cc
Electrical ECG
Signals ....................................................................	RA, LA, RL, LL, V
Waveform ...............................................................	Lead II
Amplitude................................................................	1 mV peak (±10%)
Connections............................................................	Signals available via the optional ECG
	adapter
Heart Rate for NIBP Simulations
Heart Rate Accuracy
With ECG disabled ............................................	±1 BPM
With ECG enabled..............................................	±1 BPM
Except for the following Patient Conditions:
Weak Pulse, Tachycardia, Obese, Geriatric.......	±1% ±1 BPM
Patient Condition Mild Exercise..........................	±1.5% ±1 BPM
Patient Condition Strenuous Exercise ................	±3% ±1 BPM

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Accessories

The following are accessories for the Tester. To order, contact your Fluke Biomedical equipment dealer and use the Fluke Biomedical part numbers provided. Table 1-4 lists standard accessories shipped with the tester. Table 1-5 lists optional accessories that must be ordered separately.

Table 1-4. Standard Accessories

Description	Quantity Shipped		Part Number
Operator's Manual	1		2196592
Warranty Card	1		2241856
Tubing and Fittings	1		2196394
Country-specific Power Cord
USA	1		284174
Schuko	1		769422
UK	1		769455
AU	1		658641
Table 1-5. Optional Accessories
Description			Part Number
Wrist Cuff Mandrel			2391875
ECG adapter			2391894
Carrying Case			2222822
RS-232 Serial Cable (9M-9F)			2238659
BP Pump 2 Ansur Plug-In			2755836

1-12

Chapter 2

Setup, Maintenance, and Support

Contents	Page
Setting up the Tester.....................................................................	2-3
Printer Output ...........................................................................	2-4
User-Defined Simulations ........................................................	2-5
Language ..................................................................................	2-6
Units of Measure ......................................................................	2-6
Self Test....................................................................................	2-8
Zero Pressure ............................................................................	2-8
Enable ECG Signal...................................................................	2-9
Maintenance and Support.............................................................	2-10
Avoiding Damage.....................................................................	2-10
Cleaning....................................................................................	2-10
Service and Calibration ............................................................	2-11
Packing Instructions .................................................................	2-11

2-1