Ps 320 Manual 1 5d1i1e

PS-320 Manual

PS-320 Patient Simulators

P/N 17225

Copyright  2000 by METRON. All rights reserved. METRON: USA__ 1345 Monroe NW, Suite 255A Grand Rapids, MI 49505 Phone: (+1) 888 863-8766 Fax: (+1) 616 454-3350 E-mail: [email protected]

________________ 30, rue Paul Claudel 91000 Evry, Phone: (+33) 1 6078 8899 Fax: (+33) 1 6078 6839 E-mail: [email protected]

NORWAY________________ Travbaneveien 1 N-7044 Trondheim, Norway Phone: (+47) 7382 8500 Fax: (+47) 7391 7009 E-mail: [email protected]

Disclaimer METRON provides this publication as is without warranty of any kind, either express or implied, including but not limited to the implied warranties of merchantability or fitness for any particular purpose. Further, METRON reserves the right to revise this publication and to make changes from time to time to the content hereof, without obligation to METRON or its local representatives to notify any person of such revision or changes. Some jurisdictions do not allow disclaimers of expressed or implied warranties in certain transactions; therefore, this statement may not apply to you. Limited Warranty METRON warrants that the PS-320 Patient Simulator will substantially conform to published specifications and to the documentation, provided that it is used for the purpose for which it was designed. METRON will, for a period of twelve (12) months from date of purchase, replace or repair any defective simulator, if the fault is due to a manufacturing defect. In no event will METRON or its local representatives be liable for direct, indirect, special, incidental, or consequential damages arising out of the use of or inability to use the PS-320 Patient Simulator, even if advised of the possibility of such damages. METRON or its local representatives are not responsible for any costs, loss of profits, loss of data, or claims by third parties due to use of, or inability to use the PS-320 Patient Simulator. Neither METRON nor its local representatives will accept, nor be bound by any other form of guarantee concerning the PS-320 Patient Simulator other than this guarantee. Some jurisdictions do not allow disclaimers of expressed or implied warranties in certain transactions; therefore, this statement may not apply to you. Trademarks Duracell is a ed trademark of Duracell, Inc.

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Table of Contents 1.

INTRODUCTION........................................................................................................................... 1.1 1.2 1.3

2.

INSTALLATION............................................................................................................................. 2.1

3.

Receipt, Inspection and Return............................................................................................2-1

OPERATING PS-320.................................................................................................................... 3.1 3.2 3.3

4.

Features................................................................................................................................. 1-1 Specifications......................................................................................................................... 1-1 General Information...............................................................................................................1-3

Controls and Terminals..........................................................................................................3-1 Power..................................................................................................................................... 3-2 Operating PS-320..................................................................................................................3-2

SIMULATING FUNCTIONS.......................................................................................................... 4.1

Simulation Function Descriptions Coming Soon...................................................................4-1

APPENDIX A - CABLE CONNECTION MATRICES.................................................... A-1 A-2 A-3 A-4 A-5 A-6 A-7 A-8

PS-320/420/440 RS-232 Cable.........................................................................................A-1 PS-320 Agilent 50 Series – Ultrasound Cable...................................................................A-2 PS-320 Agilent 50 Series Toco – External Cable..............................................................A-3 PS-320 Agilent 50 Series Toco – IUP Cable......................................................................A-4 PS-320 Agilent 8040 Toco – IUP Cable.............................................................................A-5 PS-320 Corometrics – Ultrasound Cable..........................................................................A-6 PS-320 Corometrics Toco – External Cable......................................................................A-7 PS-320 Corometrics Toco – IUP Cable.............................................................................A-8

APPENDIX B - ERROR REPORT FORM ............................................................................................. APPENDIX C - IMPROVEMENT SUGGESTION FORM ......................................................................

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Manual Revision Record This page is for recording revisions to your PS-320 Manual that have been published by METRON AS or its authorized representatives. We recommend that only the management or facility representative authorized to process changes and revisions to publications do so:

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

make the pen changes or insert the revised pages;



ensure that obsolete pages are withdrawn and either disposed of immediately, or marked as superseded and placed in a superseded document file, and;



enter the information below reflecting that the revisions have been entered.

Rev No

Date Entered

0

12-6-2000

Reason Initial Release

Signature of Person Entering Change

METRON

1. Introduction This chapter describes the METRON PS-320 Patient Simulator’s features and specifications. 1.1 F e a t u r e s PS-320 is a compact, lightweight high performance simulator designed to be used by trained service technicians for fetal monitor testing. Cardiotocographs or Electronic Fetal Monitoring (“EFM”) is a diagnostic tool used to identify a fetus at risk for neurological injury or death, so that timely and appropriate intervention can be carried out before the underlying condition causes irreversible damage. The goal of EFM is to detect fetal hypoxia at its earliest stage, and to attempt to prevent asphyxia resulting from prolonged and severe hypoxia. The PS-320 provides comprehensive simulation of fetal and maternal ECG as well as uterine activity. It can simulate several fetal parameters, including twins, via monitor modes as DECG and ultrasound. PS-320 offers an easy interface providing a 2 x 16 character LCD display with adjustable contrast. The unit runs on a 9V battery and it provides an indication when the battery is low and shuts down. It also supplies RS232 two-way data communication that is used to control the selections of the unit. The RS232 can also provide information regarding the status of the PS320.

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1.2 S p e c i f i c a t i o n s 1.

Fetal ECG 5 Leads with independent outputs Fetal ECG Static Rates: 30, 60, 90, 120, 150, 180, 210, 240 BPM ECG sensitivity 50μV, 100 μV, 200 μV, 500 μV, 1mV, 2 mV US-1 Tracks the fetal ECG Rates

2.

Fetal Patterns

NOTE: US-1 and Fetal ECG track these selections. US-2 is in normal pattern, except during TREND#1 Selection. TREND#1 – TWIN FETAL PATTERNS:

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NORMAL TACHYCARDIA BRADYCARDIA ARRHYTHMIAS LATE DECELERATION EARLY DECELERATION MODERATE DECELER. ACCELERATION #1 ACCELERATION #2 SINUSOIDAL (HIGH)

Normal pattern Tachycardia pattern Bradycardia pattern Arrhythmia pattern Late deceleration Early deceleration Moderate variable deceleration Acceleration wave #1 Acceleration wave #2 Sinusoidal pattern, large change

SINUSOIDAL (LOW) SEVERE VAR. DEC. #1 SEVERE VAR. DEC. #2 PROLONGED DECELER. BIPHASIC DECELERAT. EXAGGERATED DECELE. NON_UNIFORM DECELE. VAR. DECELERATION (U) VAR. DECELER. TACH VAR. DECELER (V) VAR. DECEL. (POST) VAR. DECELERATION

Sinusoidal pattern, small change Severe deceleration wave #1 Severe deceleration wave #2 Prolonged deceleration Biphasic deceleration Exaggerated deceleration Non-uniform deceleration (2 different shapes) Variable deceleration “U” shaped Variable deceleration with high rate BPM Variable deceleration “V” shaped Variable deceleration post exaggerated Variable deceleration

DECELER. (POSITION) Variable deceleration with position changes LONG DECELERATION Long deceleration COMPENSATORY ACCEL. Compensatory acceleration

3.

Maternal ECG Maternal ECG Static Rates: 60, 80, 100, 120, 140, 160 BPM ECG sensitivity 0.5 mV, 1 mV and 2 mV Pattern is selected during Trend #1 selection

4.

Uterine Activity Note: Toco waveform selection not available during TREND #1 EXECUTE WAVEFORM UTERINE WAVE OFF ANALOG 0 TO +1 VOLT ANALOG 0 TO -1 VOLT UTERINE WAVE 0-25 UTERINE WAVE 0-50 UTERINE WAVE 0-100 SHORT DURATION NORMAL DURATION INCREASED DURATION UTERINE LEVEL =ZERO UTERINE STATIC +20 INCR. RESTING TONE COUPLING TRIPLING UTERINE PRESSURE SENSIVITY

Start toco waveform Stop toco waveform Analog range 0 to +1 V (1 V=100 mmHg) Analog range 0 to -1 V (-1 V=100 mmHg) Range of toco waveform Range of toco waveform Range of toco waveform Toco waveform of short duration Normal duration of toco waveform Long duration of toco waveform Zero toco channel (automatic on power up) Increase toco static level by 20 mmHg (0-100 mmHg) Resting tone increases 2 close toco waves 3 close toco waves 5 or 40 μV on power up

5.

6.

Respiration

3

7.

Temperature

1.3 General Information Display/Control: RS232 Interface: ECG & US Output Connectors Power: Case: Weight (w/o batt.): Dimensions:

Part No: Standard Accessories: Optional Accessories:

16-digit alphanumeric display keys 2 and Power ON/OFF Bi-directional interface. Baud rate: 9600 5 AHA/IEC connectors accepting ECG snaps and pins. 9 V alkaline battery or battery eliminator High impact plastic 0.343 kg / 12.1 oz. Height: 3.4 cm / 1.4 in. Width: 10.7 cm / 4.2 in. Length: 16.0 cm / 6.3 in. PS-320 Patient Simulator (P.N. 17150) PS-320 Manual (P.N. 17226) High Impact Plastic Carrying Case (P.N. 17260) 110 V or 220 V AC Adapter/ Battery Eliminator (P.N. 17021) Mechanical Infant Heart (P.N. 17155) Agilent 50 Series - Ultrasound Cable (P.N. 17482) Agilent 50 Series TOCO - External Cable (P.N. 17484) Agilent 50 Series TOCO - IUP Cable (P.N. 17487) Agilent 8040 Series TOCO - IUP Cable(P.N. 17488) Corometrics - Ultrasound Cable (P.N. 17483) Corometrics TOCO - External Cable (P.N. 17481) Corometrics TOCO - IUP Cable (P.N. 17486) RS-232 Cable PS-320/420/440 (P.N. 17291) * your local METRON Sales Agent for further details

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2. Installation This chapter explains unpacking, receipt inspection and claims, and the general procedures for PS-320 setup. 2.1 Receipt, Inspection and Return 1.

Inspect the outer box for damage.

2.

Carefully unpack all items from the box and check to see that you have the following items: 

PS-320 Patient Simulator (P.N. 17150)



PS-320 Manual (P.N. 17226)



High Impact Plastic Carrying Case (P.N. 17260)

3.

If you note physical damage, or if the unit fails to function according to specification, inform the supplier immediately. When METRON or the Company’s Sales Agent, is informed, measures will be taken to either repair the unit or dispatch a replacement. The customer will not have to wait for a claim to be investigated by the Sales Agent. The customer should place a new purchase order to ensure delivery.

4.

When returning an instrument to METRON, or the Sales Agent, fill out the address label, describe what is wrong with the instrument, and provide the model and serial numbers. If possible, use the original packaging material for return shipping. Otherwise, repack the unit using: 

a reinforced cardboard box, strong enough to carry the weight of the unit.



at least 5 cm of shock-absorbing material around the unit.



nonabrasive dust-free material for the other parts.

Repack the unit in a manner to ensure that it cannot shift in the box during shipment. METRON’s product warranty is on page ii of this manual. The warranty does not cover freight charges. C.O.D. will not be accepted without authorization from METRON or its Sales Agent.

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fe ta l fe ta l

fe ta l

am pl

m a te r n a l m a t.

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5 uV

40 uV

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2

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3. Operating PS-320 This chapter describes the controls and terminals of the PS-320 and Fetal Simulator. It also provides basic instructions on operating the simulator. 3.1 Controls and Terminals PS-320 Top 1. Battery Eliminator

2. Power Switch

2.1 mm micro jack for connecting a 9 V plug-in power supply transformer for use in operating the unit from any standard electrical outlet. The jack polarity is center negative. We recommend you use METRON’s AC Adapter (P.N. 17021), available separately from your METRON Sales Agent. Turns the power on and off.

PS-320 Front 3. LCD Display 4. Keypad Control Keys enter main sub scroll view LCD / LCD 5. Keypad Soft Keys fetal

/ fetal

ampl mat.

/ mat.

ampl toco 5 μV 40 μV 6. ECG Connectors

15 mm x 60 mm (.58 in. x 2.37 in.) window displaying up to two lines of 20 point font. Enters the selected code line value into memory. Selects the main headings or groupings. Selects the functions within the main menu. Scrolls selections back whether within the main menu or sub menu. Pressing “view” scrolls through the currently active functions. Changes the contrast of the display. These keys have one-step selection of simulator functions. Scrolls selections through available fetal heart rate parameters. Scrolls selections through available amplitude parameters. Scrolls selections through available maternal heart rate parameters. Scrolls selections through available amplitude parameters. Scrolls selections through available TOCO parameters. Selects sensitivity of 5 μV. Selects sensitivity of 40 μV. Five snap and multi-banana connectors for ECG output, allowing for connection to any ECG. These terminals are labeled and on the left side . Labels and their definitions are as follows: Label Definition Fetal Fet/Mat Maternal Reference

Fetal ECG signal Fetal and Maternal ECG signal. Fetal signal is approximately ½ of the Fetal amplitude selected Maternal ECG signal Ground reference lead

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7. RS-232

8. Toco

9. US1 & US2

6-pin mini-DIN plug connector for the serial connection. The cable connection matrix for the serial cable is shown in Appendix A. 6-pin mini-DIN connector for the TOCO signal cable. The connection matrix for the cable is shown in Appendix A. 8-pin mini-DIN plug connector for ultrasound cable plugs. The cable connection matrix is shown in Appendix A.

3.2 P o w e r 1. The simulator uses a 9 V alkaline battery (Duracell  MN1604 or equivalent). It is designed to use as much of the battery as possible. When it detects less than about 5.6 volts, it goes into a shutdown mode, sounds a continuous tone alarm and displays the following message: NOTE Remove the batteries and disconnect the AC Adapter / Battery Eliminator if you do not intend to use the PS-320 for an extended period of time.

The battery is situated in the base of the instrument. Use a 9 volt alkaline battery (Duracell  MN1604 or equivalent). Do not use mercury, air or carbon-zinc batteries. 2.

As an alternative to batteries you can power the simulator with a 2.1 mm size plug AC adapter (for example, METRON’s AC Adapter/Battery Eliminator, P.N. 17021). The adapter voltage must not exceed 14.5 volts.

3.

The battery eliminator must be used when using the fetal heart simulator option.

3.3 Operating PS-320 Operating the simulator is simple. Connect the simulator to the device under test. By using the simulator’s keypad you can select the code presets. The simulator then transmits these values to the device.

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1.

First connect your ECG leads. The active lead will go on the Fetal, Fet/Mat, or Maternal points as appropriate. The reference lead will be connected to the reference point.

2.

Switch the simulator ON. The LCD window displays the program version for about two seconds.

The window then displays the default code entry display. 3.

Use the keypad to indicate the desired parameter then press “enter”. This will activate the new parameter.

4. At any point you can view the simulator’s current parameter settings simply by pressing “view”. Repeated pressing of “view” will scroll through all of the settings. NOTE Only use the enter key when scrolling through the current settings. Using a menu scroll or change key interrupts the scrolling operation.

The first parameter setting (“TOCO=00 5μV”) is then displayed. Thereafter, each time you press view, current settings are displayed in the following sequence: TOCO=00 5μV MAT SENS. @ 1mV FET SENS. @ 1mV US1=150 US2=NORM FETHR=150 STATIC MATERNAL HR=100

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4. Simulating Functions This chapter describes PS-320 simulation procedures by function. If you are unfamiliar with the simulators’ basic operation, refer to paragraph 1.3, Operating PS-320. 4.1 S i m u l a t i o n F u n c t i o n D e s c r i p t i o n s C o m i n g S o o n Coming soon

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4.2

7. 9. 10. 11. 1. NOTE The number value on the Injec. temp. dial is a relative setting for obtaining the same value on identical monitors. It does not indicate a numerical temperature value.

2.

3.

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Revision 2 Revision 2

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Appendix A - Cable Connection Matrices

A.1 PS-320/420/440 RS-232 Cable

A-1

A.2

A-2

PS-320 Agilent 50 Series – Ultrasound Cable

A.3

PS-320 Agilent 50 Series Toco – External Cable

A-3

A.4

A-4

PS-320 Agilent 50 Series Toco – IUP Cable

A.5

PS-320 Agilent 8040 Toco – IUP Cable

A-5

A.6

A-6

PS-320 Corometrics – Ultrasound Cable

A.7

PS-320 Corometrics Toco – External Cable

A-7

A.8

A-8

PS-320 Corometrics Toco – IUP Cable

Appendix B A.1 A-2

B.1

A-1

A-2

B.2

A-3

A-4

A-5

A-6

A-7

A-8

A-9

USA 1345 Monroe NW, Suite 255A Grand Rapids, MI 49505 Phone: (+1) 888 863-8766 Fax: (+1) 616 454-3350 E-mail: [email protected]

From: (name) Address:

Product:

30, rue Paul Claudel 91000 Evry, Phone: (+33) 1 6078 8899 Fax: (+33) 1 6078 6839 E-mail: [email protected]

                       

Phone: Fax: E-mail: Date:

Error Report

     

Version:

Description of the situation prior to the error:

     

NORWAY Travbaneveien 1 N-7044 Trondheim, Norway Phone: (+47) 7382 8500 Fax: (+47) 7391 7009 E-mail: [email protected]

                       

Serial no.:

     

     

Description of the error:      

(METRON AS internally) Comments:      

Received date:      

Correction date:      

Ref No.      

Critical

Normal

Minor

F-1

USA 1345 Monroe NW, Suite 255A Grand Rapids, MI 49505 Phone: (+1) 888 863-8766 Fax: (+1) 616 454-3350 E-mail: [email protected]

From: (name) Address:

Product:

30, rue Paul Claudel 91000 Evry, Phone: (+33) 1 6078 8899 Fax: (+33) 1 6078 6839 E-mail: [email protected]

                       

     

Phone: Fax: E-mail: Date:

NORWAY Travbaneveien 1 N-7044 Trondheim, Norway Phone: (+47) 7382 8500 Fax: (+47) 7391 7009 E-mail: [email protected]

                       

Improvement Suggestion Version:

Description of the suggested improvement:

     

     

(METRON AS internally) Comments:      

Received date:      

G-1

Correction date:      

Ref No.      

Critical

Normal

Minor

USA 1345 Monroe NW, Suite 255A Grand Rapids, MI 49505 Phone: (+1) 888 863-8766 Fax: (+1) 616 454-3350 E-mail: [email protected]

30, rue Paul Claudel 91000 Evry, Phone: (+33) 1 6078 8899 Fax: (+33) 1 6078 6839 E-mail: [email protected]

NORWAY Travbaneveien 1 N-7044 Trondheim, Norway Phone: (+47) 7382 8500 Fax: (+47) 7391 7009 E-mail: [email protected]

A-1