1. Introduction



PS-420320/440

User Manual

PS-420 and PS-440320 Patient Simulators

[pic]

P/N 17225

Copyright ( 19992000 by METRON. All rights reserved.

METRON:

USA FRANCE ________________ NORWAY________________

1345 Monroe NW, Suite 255A 30, rue Paul Claudel Travbaneveien 1

Grand Rapids, MI 49505 91000 Evry, France N-7044 Trondheim, Norway

Phone: (+1) 888 863-8766 Phone: (+33) 1 6078 8899 Phone: (+47) 7382 8500

Fax: (+1) 616 454-3350 Fax: (+33) 1 6078 6839 Fax: (+47) 7391 7009

E-mail: support.us@metron- E-mail: info@metron.fr E-mail: support@metron.no

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; therefore, this statement may not apply to you.

Limited Warranty

METRON warrants that the PS-4320/PS-440 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-3420/PS-440 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-3420/PS-440 Patient Simulator. Neither METRON nor its local representatives will accept, nor be bound by any other form of guarantee concerning the PS-3420/PS-440 Patient Simulator other than this guarantee. Some jurisdictions do not allow disclaimers of expressed or implied warranties in certain transactions; therefore; therefore, this statement may not apply to you.

Trademarks

Duracell is a registered trademark of Duracellof Duracell, Inc.

Table of Contents

1. Introduction 1-1

1.1 Features 1-1

1.2 Specifications 1-1

1.3 General Information 1-3

2. Installation 2-1

2.1 Receipt, Inspection and Return 2-1

3. Operating PS-320 3-1

3.1 Controls and Terminals 3-1

3.2 Power 3-2

3.3 Operating PS-320 3-2

4. Simulating Functions 4-1

4.1 Simulation Function Descriptions Coming Soon 4-1

Appendix A - Cable Connection Matrices A-1

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

A-2 PS-320 Agilent 50 Series – Ultrasound Cable A-2

A-3 PS-320 Agilent 50 Series Toco – External Cable A-3

A-4 PS-320 Agilent 50 Series Toco – IUP Cable A-4

A-5 PS-320 Agilent 8040 Toco – IUP Cable A-5

A-6 PS-320 Corometrics – Ultrasound Cable A-6

A-7 PS-320 Corometrics Toco – External Cable A-7

A-8 PS-320 Corometrics Toco – IUP Cable A-8

1. Introduction 1-11-11-1

1.1 Features 1-11-11-1

1.2 Specifications 1-11-11-1

1.3 General Information 1-31-31-3

2. Installation 2-12-12-1

2.1 Receipt, Inspection and Return 2-12-12-1

3. Operating PS-420/PS-440 3-13-13-1

3.1 Controls and Terminals 3-13-13-1

3.2 Power 3-23-23-3

3.3 Operating PS-420/440 3-23-33-3

4. Simulating Functions 4-14-14-1

4.1 Temperature 4-14-14-1

4.2 Respiration 4-14-14-1

4.3 Blood Pressure 4-14-34-3

4.4 ECG/Arrhythmia 4-44-54-5

4.5 Cardiac Output 4-84-94-9

4.6 ECG Performance Testing 4-94-104-10

Appendix A - Codes and Descriptions A-111

A-1 Keypad Control A-111

A-2 Two-Function Keys A-111

A-3 Preset Codes A-111

Appendix B - Temperature Cable Connection Matrices B-111

B-1 PS-420/440 Temperature Cable – YSI 400 Series B-111

B-2 PS-420/440 Temperature Cable – YSI 700 Series B-222

B-3 PS-420/440 Temperature Cable – HP-YSI 400 Series B-333

B-4 PS-420/440 Universal Temperature Cable - Unterminated B-444

Appendix C - Cardiac Output Cable Connection Matrices C-111

C-1 COA-G Cardiac Output Adapter C-111

C-2 COA-HP Cardiac Output Cable – Monitor Type: HP C-222

C-3 COA-1 Cardiac Output Cable – YSI 400 Series C-333

C-4 COA-2 Cardiac Output Cable – YSI 700 Series C-444

Appendix D - Blood Pressure Cable Connection Matrices D-111

D-1 PS-420/440 BP Cable – Monitor Type: GE-2 D-111

D-2 PS-420/440 BP Cable – Monitor Type: GE-3 D-222

D-3 PS-420/440 BP Cable – Monitor Type: HP-1 D-333

D-3 PS-420/440 BP Cable – Monitor Type: HP-2 D-444

D-4 PS-420/440 BP Cable – Monitor Type: HP-3 D-555

D-5 PS-420/440 BP Cable – Monitor Type: HP-4 D-666

D-6 PS-420/440 BP Cable – Monitor Type: HP-8 D-777

D-7 PS-420/440 BP Cable – Monitor Type: HP-9 D-888

D-8 PS-420/440 BP Cable – Monitor Type: KT-1 D-999

D-9 PS-420/440 BP Cable – Monitor Type: LT-1 D-101010

D-10 PS-420/440 BP Cable – Monitor Type: MM-1 D-111111

D-11 PS-420/440 BP Cable – Monitor Type: MQ-2 D-121212

D-12 PS-420/440 BP Cable – Monitor Type: MQ-3 D-131313

D-13 PS-420/440 BP Cable – Monitor Type: NK-1 D-141414

D-14 PS-420/440 BP Cable – Monitor Type: PB-2 D-151515

D-15 PS-420/440 BP Cable – Monitor Type: PC-1 D-161616

D-16 PS-420/440 BP Cable – Monitor Type: SL-1 D-171717

D-17 PS-420/440 BP Cable – Monitor Type: SM-1 D-181818

D-18 PS-420/440 BP Cable – Monitor Type: SM-3 D-191919

D-19 PS-420/440 BP Cable – Monitor Type: TK-1 D-202020

D-20 PS-420/440 Universal Pressure Cable – Unterminated D-212121

Appendix E - PS-420/440 RS-232 Cable Connection Matrix E-111

Appendix FB - ERROR REPORT form BF-1

Appendix CG - IMPROVEMENT suggestion form CG-1

Manual Revision Record

This record page is for recording revisions to your PS-420/PS-440320 User 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:

• 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 |Reason |Signature of Person Entering Change |

|0 |1999-01-0812-6-20|Initial Release |METRON |

| |00 | | |

|1 |1999-06-18 |Addition of appendixes. |METRON |

|2 |2000-04-24 |Addition of COA-G instructions. |METRON |

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Introduction

This chapter describes the METRON PS-420 and PS-440 320 Patient Simulator’s’ features and specifications.

1 Features

PS-420 320 and PS-440 areis a compact, lightweight high performance simulators designed to be used by trained service technicians for patient 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 user 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 PS-320.Through settings manipulated by the operator they simulate various electrocardiogram, respiration, blood pressure, temperature and cardiac output conditions. The difference between them is in blood pressure simulation: PS-420 offers two-channel simulation, while PS-440 offers four-channel simulation.

2 Specifications

1. Fetal ECG

|12 5 Leads with independent outputs referenced to RL |

|Fetal ECG Static Rates: |30, 60, 90, 120, 150, 180, 210, 240 BPM500, 1000, 1500 |

|Baseline Impedances |or 2000 Ohms for Leads I, II and III |

|ECG sensitivityRates: |50μ30, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, |

| |240, 260, 280, and 300 BPMV, 100 μV, 200 μV, 500 μV, |

| |1mV, 2 mV |

|US-1Default Rate: |Tracks the fetal ECG Rates80 BPM. |

2. PacemakerFetal 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:

|NORMALPacer Spike Amplitude: |N2, 4, 6, 8 and 10 mV in Lead IIormal pattern |

|TACHYCARDIA |Tachycardia pattern |

|BRADYCARDIA |Bradycardia pattern |

|ARRHYTHMIAS |Arrhythmia pattern |

|LATE DECELERATION |Late deceleration |

|EARLY DECELERATION |Early deceleration |

|MODERATE DECELER. |Moderate variable deceleration |

|ACCELERATION #1 |Acceleration wave #1 |

|ACCELERATION #2 |Acceleration wave #2 |

|SINUSOIDAL (HIGH) |Sinusoidal pattern, large change |

|SINUSOIDAL (LOW) |Sinusoidal pattern, small change |

|SEVERE VAR. DEC. #1 |Severe deceleration wave #1 |

|SEVERE VAR. DEC. #2 |Severe deceleration wave #2 |

|PROLONGED DECELER. |Prolonged deceleration |

|BIPHASIC DECELERAT. |Biphasic deceleration |

|EXAGGERATED DECELE. |Exaggerated deceleration |

|NON_UNIFORM DECELE. |Non-uniform deceleration (2 different shapes) |

|VAR. DECELERATION (U) |Variable deceleration “U” shaped |

|VAR. DECELER. TACH |Variable deceleration with high rate BPM |

|VAR. DECELER (V) |Variable deceleration “V” shaped |

|VAR. DECEL. (POST) |Variable deceleration post exaggerated |

|VAR. DECELERATION |Variable deceleration |

|DECELER. (POSITION) |Variable deceleration with position changes |

|LONG DECELERATION |Long deceleration |

|COMPENSATORY ACCEL. |Compensatory acceleration |

3. Arrhythmia SelectionsMaternal ECG

|Maternal ECG Static Rates: Sinus |60, 80, 100, 120, 140, 160 BPMPVCs 24 / |

|Arrhythmia |minute |

|ECG sensitivityAtrial (PAC) * | 0.5 mV, 1 mV and 2 mVFrequent Multifocal |

| |PVCs |

|Missed Beat *Pattern is selected during Trend #1 selection |

|Bigeminy |

4. 4. Blood PressureUterine Activity

Note: Toco waveform selection not available during TREND #1

|EXECUTE WAVEFORM |Start toco waveform |

|UTERINE WAVE OFF |Stop toco waveform |

|ANALOG 0 TO +1 VOLT |Analog range 0 to +1 V (1 V=100 mmHg) |

|ANALOG 0 TO -1 VOLT |Analog range 0 to -1 V (-1 V=100 mmHg) |

|UTERINE WAVE 0-25 |Range of toco waveform |

|UTERINE WAVE 0-50 |Range of toco waveform |

|UTERINE WAVE 0-100 |Range of toco waveform |

|SHORT DURATION |Toco waveform of short duration |

|NORMAL DURATION |Normal duration of toco waveform |

|INCREASED DURATION |Long duration of toco waveform |

|UTERINE LEVEL =ZERO |Zero toco channel (automatic on power up) |

|UTERINE STATIC +20 |Increase toco static level by 20 mmHg (0-100 mmHg)|

|INCR. RESTING TONE |Resting tone increases |

|COUPLING |2 close toco waves |

|TRIPLING |3 close toco waves |

|UTERINE PRESSURE SENSIVITY |5 or 40 μV on power up |

5. Cardiac Output Option

|Catheter Type: |Baxter-Edwards, 10cc |

|Blood Temperature: |37(C / 98.6(F and 36 °C / 95.9 °F |

|CO for 2 Degrees: |3, 5, and 7 L/Min |

|CO for 20 Degrees: |3, 5, and 7 L/Min |

|Cal Pulse: |Of 1 degree for 1 second |

| |Of delta 402 Ohms for 4 seconds |

|Computational Constant | |

| 2 Degrees: |0.561 |

| 20 Degrees: |0.608 |

|Left to Right Shunt |2 and 20 Degrees |

|Faulty Injectate |2 and 20 Degrees |

|Calibrated or uncalibrated cardiac output waves for 4 different CO values |

6. Respiration

|Baseline Impedances: |500, 1000, 1500, 2000 Ohms (Leads I - III) |

|Lead Selection: |LL or LA |

|Impedance Variations: |0.2, 0.5, 1.0, and 3.0 Ohms |

|Rates: |0 (apnea), 15, 20, 30, 40, 60, 80, 100, 120 BPM |

|Apnea: |12 sec, 22 sec, 32 sec, and continuous |

7. Temperature

|30(C/86(F, 35(C/95(F, 37(C/98.6(F, 40(C/ 104(F, 42(C/107.6(F |

|Compatible with YSI 400/700 series. |

1.3 General Information

|Display/Control: |16-digit alphanumeric numeric display keys |

| |2 switches for Respiratory Leads LL/LA and Power ON/OFF |

|RS232 Interface: |Bi-directional interface. Baud rate: 9600 |

|ECG & US Output Connectors |10 5 AHA/IEC color-coded connectors accepting ECG snaps and |

| |pins. |

|Power: |9 V alkaline battery or battery eliminator |

|Case: |High impact plastic |

|Weight (w/o batt.): |0.343 kg / 12.1 oz. |

|Dimensions: |Height: 3.4 cm / 1.4 in. |

| |Width: 10.7 cm / 4.2 in. |

| |Length: 16.0 cm / 6.3 in. |

|Part No: |PS-3420 Patient Simulator (P.N. 17150200) |

| |PS-440 Patient Simulator (P.N. 17250) |

|Standard Accessories: |PS-420/PS-440320 User Manual (P.N. 172256) |

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

|Optional Accessories: |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)Cardiac Output |

| |Adapter Box, |

| |PS-420/440 (P.N. 17290) |

| |Temperature Cable * |

| |Blood Pressure Cable * |

| |Cardiac Output Cable * |

| |* Contact your local METRON Sales Agent for further details |

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Installation

This chapter explains unpacking, receipt inspection and claims, and the general procedures for PS-420/440320 setup.

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:

1. PS-3420 Patient Simulator (P.N. 1720017150); or PS-440 Patient Simulator (P.N. 17250)

2. PS-320420/440 User Manual (P.N. 172265)

3. 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 Ccompany’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:

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

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

6. 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.

[pic][pic]

Operating PS-4320/PS-440

This chapter describes the controls and terminals of the PS-3420 and PS-440 PatientFetal Simulators. It also provides basic instructions on operating the simulators.

1 Controls and Terminals

PS-3420/440 Top Panel

|1. Battery Eliminator |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. |

|2. Power Switch |Turns the power on and off. |

PS-420/440320 Front Panel

|34. LCD Display |15 mm x 60 mm (.58 in. x 2.37 in.) window displaying up |

| |to two lines of 20 point font. |

|45. Keypad Control Keys | |

| enter |Enters the selected code line value into memory. |

| menu scroll main |Causes the code line number to increase or decrease. The|

| |display arrows indicate which menu scroll to use. The |

| |right menu scroll [pic] increases the code lines by 1, |

| |while the left menu scroll [pic] decreases the code |

| |lines by 1.Selects the main headings or groupings. |

| sub |Selects the functions within the main menu. |

| scroll |Scrolls selections back whether within the main menu or |

| |sub menu. |

| view |Pressing “view” scrolls through the currently active |

| |functions. |

| LCD[pic] / LCD[pic] change |Changes the contrast of the display.These keys are |

| |functional when the top line in the LCD window displays |

| |the up/down arrows [pic] [pic]. They allow the user to |

| |increment or decrement the current setting. The up |

| |change arrow [pic] increases the preset codes by 1, |

| |while the down change arrow [pic] decreases the preset |

| |codes by 1. |

|56. Keypad Soft Keys |These keys have two functions: numeric and one-step |

| |selection of simulator functions. |

| fetal[pic] / fetal[pic] 0 /|Scrolls selections through available fetal heart rate |

|status |parameters.Enters a numeric 0 to code line. |

| |Displays current parameter settings. |

| ampl[pic] 1 / temp |Scrolls selections through available amplitude |

| |parameters.Enters a numeric 1 to code line. |

| |Changes temperature. |

| mat.[pic] / mat.[pic] 2 / |Scrolls selections through available maternal heart rate|

|resp rate |parameters.Enters a numeric 2 to code line. |

| |Changes respiration rate. |

| ampl[pic] 3 / base-line |Scrolls selections through available amplitude |

| |parameters.Enters a numeric 3 to code line. |

| |Changes baseline resistance. |

| toco[pic] 4 / bp static |Scrolls selections through available TOCO |

| |parameters.Enters a numeric 4 to code line. |

| |Sets BP channels static levels. |

| 5 μV |Selects sensitivity of 5 μV. |

| 40 μV 5 / bp wavef. |Selects sensitivity of 40 μV.Enters a numeric 5 to code |

| |line. |

| |Sets BP channels to BP waveforms. |

|67. ECG Connectors |Ten Five snap and multi-banana connectors for ECG |

| |output, allowing for connection to any twelve-lead ECG. |

| |These terminals are labeled and on the top left side |

| |panel. The labels are AHA/IEC color-coded to aid in |

| |matching them to corresponding patient leads. Labels |

| |and their definitions are as follows: |

| |Label |Definition |

| |RA / RFetal |Right ArmFetal ECG signal |

| |LA / |Left ArmFetal and Maternal ECG signal. |

| |LFet/Mat |Fetal signal is approximately ½ of the |

| | |Fetal amplitude selected |

| |RL / |Right Leg (Reference or grounded)Maternal |

| |NMaternal |ECG signal |

| | |Left Leg |

| |LL / |V leads (US and Canada). Also referred to |

| |FReference |as pericardial, precordial or unipolar |

| |V1 / C1 to |chest leads, and chest leads (IEC)Ground |

| |V6 / C6 |reference lead |

[pic]

[pic]

| 7 8. CO / Temp 1& 2RS-232 |86-pin mini-DIN plug connector for the Cardiac Output|

| |and Temperature cablesserial connection. Use METRON’s|

| |Cardiac Output Adapter Box, PS-420/440 (P.N. 17290), |

| |available separately from your METRON Sales Agent. |

| |The cable connection matrixces for the Cardiac Output|

| |and Temperatureserial cables areis shown in |

| |Appendixes AB and C, respectively.: |

| 8 9. BP 1 (PS-420) |68-pin mini-DIN connectors for BP cable plugthe TOCO|

|BP 2&3 (PS-440)Toco |signal cables. The connection matrix for the blood |

| |pressure cable is shown in Appendix AD. |

|9. US1 & US2BP 2 / RS-232 |8-pin mini-DIN plug connector for BP ultrasound |

|(PS-420 |cable plugs, as above, and for connecting an RS-232.|

|BP 4 / RS-232 (PS-440) |. The cable connection matrix is shown in Appendix |

| |AD. |

2 Power

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:

[pic]

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 Operating PS-4320/440

Operating the simulator is simple. Connect the simulator to the device under test. By using the simulator’s 16-digit alphanumeric keypad you can enter select the code presets. The simulator then transmits these values to the device.

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.

[pic]

The window then displays the default code entry display.

[pic]

The display arrows indicate which menu scroll to use. The right menu scroll [pic] increases the preset codes by 1, while the left menu scroll [pic] decreases the preset codes by 1. For example, pressing the right menu scroll once will display the first preset, “0=VIEW”.

Key

3. Use the keypad to indicate the desired parameter then press

“enter”. This will activate the new parameter.[pic]

To adjust some settings you can use the keypad’s two-function alphanumeric keys. For temperature, as an example, press 1, then enter. The LCD displays the current preset.

[pic]

Note the two additional up and down arrows. These indicate which way to increase or decrease the preset. Use the menu change arrows for scrolling through the presets. The up change arrow [pic] increases the preset codes by 1, while the down change arrow [pic] decreases the preset codes by 1. You can then advance through all the temperature settings:

|[pic] |[pic] |189 |= |42 °C /| 107.6 °F |

|[pic] |[pic] |188 |= |40 °C /| 104 °F |

|[pic] |[pic] |187 |= |37 °C /| 98.6 °F |

|[pic] |[pic] |186 |= |35 °C /| 95 °F |

|[pic] |[pic] |185 |= |30 °C /| 86 °F |

After reaching the desired preset, press enter. This now becomes the active temperature. Press clear to return to the default code entry display.

4. AAt any point you can view the simulator’s current parameter settings simply by pressing status (0). “0=VIEW” is then displayed:“view”. Repeated pressing of “view” will scroll through all of the settings.

[pic]

Press enter. The first parameter setting (“TOCO=00 5μVECG=NSR”) is then displayed. Thereafter, each time you press enterview, current settings are displayed in the following sequence:

|ECG NSR TOCO=00 5μV |Normal sinus rhythm in BPM. |

|NSR QRSMAT SENS. @ 1mV |Adult or pediatric waveform. |

|FET SENS. @ 1mVECG AMPL |ECG amplitude in mV. |

|RESP RATEUS1=150 US2=NORM |Respiration rate in RPM. |

|R DELTA FETHR=150 STATIC |Impedance variation in ohms. |

|BASELINE MATERNAL HR=100 |Baseline impedance in ohms. |

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Simulating Functions

This chapter describes PS-4320 and PS-440 simulation procedures by function. For a numerical listing of code line presets, see Appendix A. If you are unfamiliar with the simulators’ basic operation, refer to paragraph 31.3, Operating PS-4320/440.

1 Temperature Simulation Function Descriptions Coming Soon

Coming soon

Both PS-420 and 440 simulate normal, hypothermic and hyperthermic conditions with five temperature presets. All temperature outputs are compatible with YSI 400/700 series probes. Temperature can be set through direct code entry, as below, by keying the preset code and pressing enter. You can also use the menu scroll keys [pic] [pic] to cycle through the other presets before pressing enter.

In addition, you can select and adjust settings by first keying 1 = TEMPERAT. or 190. If you key 1 press enter and use the change keys [pic] [pic] to cycle through the presets. Then press enter to set the temperature. If you key 190 press enter and use the menu scroll keys [pic] [pic] to cycle through the other presets. Then press enter to set the temperature.

|Code = Display |Selects temperature of: |

| | |

|185 = TEMP 30C |30 °C / 86 °F. |

|186 = TEMP 35C |35 °C / 95 °F |

|187 = TEMP 37C |37 °C / 98.6 °F |

|188 = TEMP 40C |40 °C / 104 °F |

|189 = TEMP 42C |42 °C / 107.6 °F |

2 Respiration

Respiration Rate. Both PS-420 and 440 simulate nine rate settings. These can be set through direct code entry, as below, by Blood Pressure

PS-420 and 440 dynamic blood pressure waveforms are synchronized with all NSR rates , and track all arrythmia selections. All blood pressure channels (BP-1 and 2 with PS-420, and BP-1 through 4 with PS-440) can be controlled. Each channel can act independently or can be set together for universal settings.

The simulators will set the blood pressure channels to a zero level on power up. This is to allow the user to set up the monitoring equipment being tested.

Transducer Sensitivity (All Channels). Before simulation can begin, blood pressure transducer sensitivity must be set to correlate with the monitor manufacturer’s specifications: 40 or 5 µV/V/mmHG. PS-420 and 440 accuracy is ± 1%, ± 1 mmHG.

The sensitivity is set through direct code entry by keying the preset code and pressing enter.

Waveform (All Channels). PS-420 and 440 can set a single waveform for all blood pressure channels. This is set by first selecting 5 = BP DYNAMIC. After selecting 5 press enter. The LCD will display BP CHANNELS SET. The waveforms will appear only during ECG waveforms where blood pressure waveforms occur (e.g., during the asystole selection, all pressure channels drop to 0 level).

Blood Pressure Artifact (All Channels). A respiratory artifact can be inserted, as required, into any waveform over all channels. Artifacts are inserted by keying 84, then pressing enter. Insertion is stopped by keying 85, then enter.

BP Static Levels (All Channels). The blood pressure static level can be set through direct code entry, as below, or selected and adjusted through first selecting 4 = BP STATIC. After selecting 4 press enter, then use the change keys [pic] [pic] to scroll to the available presets.

7. BP Static Levels, Channels 1 and 2. BP Static Leve setting remains in effect until changed, or the simulator is turned off.

8. ECG Rate. PS-420 and 440 simulate fifteen heart rates, with a ± 1% accuracy of selection. These are set by selecting 7 = ECG RATE. After selecting 7 and pressing enter, use the change keys [pic] [pic] to scroll to the available presets. Then press enter to set the rate.

9. Superimposed Artifacts. PS-420 and 440 simulate five different artifacts. Their purpose is to evaluate the effect of these type artifacts on ECG accuracy. After selecting the artifact press enter to transmit it to the ECG. The artifact is deactivated when another ECG or arrythmia selection is made.

10. Pacemaker. PS-420 and 440 simulate six paced rhythms/signals. After selecting the desired rhythm press enter. Use the change keys [pic] [pic] to scroll through the available rhythms.

11. Pacemaker Pulse Amplitudes, Lead II. When any pacemaker waveform is selected you can adjust and set pulse amplitudes in Lead II. These can be set through direct code entry, as below, or selected and adjusted through first selecting 64 = PACE AMP. After selecting 64 press enter, then use the change keys [pic] [pic] to scroll to the available presets.

12. Pacemaker Pulse Width. When any pacemaker waveform is selected you can adjust and set pulse width. These can be set through direct code entry, as below, or selected and adjusted through first selecting 65 = PACE WIDTH. After selecting 65 press enter, then use the change keys [pic] [pic] to scroll to the available presets.

4 Cardiac Output

The cardiac output option is detected by the software when the user connects the Cardiac Output Adapter Box (P.N. 17290) or direct cardiac output cable. (See Appendix C) To set up the cardiac output procedure you must match the computational constant for the injectate temperature required. You must then adjust the injectate temperature pot to the required value for the model used. Use the following procedure:

Set the computational constant on your monitor under test to 0.561 for 2°C, or 0.608 for 20°C injectate temperature.

Connect the cable from the Cardiac Output Adapter Box to the CO/Temp1&2 port on the right side of the PS-420/440.

Connect the cable for the injectate temperature into the Injec. temp. port on the Cardiac Output Adapter Box.

Connect the cable for the blood temperature into the Blood temp. port on the Cardiac Output Adapter Box.

You may also connect any other temperature probes through the Temp. 1&2 port on the Cardiac Output Adapter Box.

Rotate the Injec. temp. dial on the face of the Cardiac Output Adapter Box until the monitor under test indicates the proper injectate temperature. This will be either 2°C or 20°C.

Once you have the injectate temperature set to either 2°C or 20°C, you are ready to run the appropriate simulation from the PS420/440. To do this:

Select the appropriate test code and then press enter.

|Code = Display |Selects: |

| | |

|107 = 3L/M @ 2C |Cardiac output wave of 3 L/min for 2 degrees. |

| |Computational constant is 0.561. |

|108 = 5L/M @ 2C |Cardiac output wave of 5 L/min for 2 degrees. |

| |Computational constant is 0.561. |

|109 = 7L/M @ 2C |Cardiac output wave of 7 L/min for 2 degrees. |

| |Computational constant is 0.561. |

|110 = 3L/M @ 20C |Cardiac output wave of 3 L/min for 20 degrees. |

| |Computational constant is 0.608. |

|111 = 5L/M @ 20C |Cardiac output wave of 3 L/min for 20 degrees. |

| |Computational constant is 0.608. |

|112 = 7L/M @ 20C |Cardiac output wave of 3 L/min for 20 degrees. |

| |Computational constant is 0.608. |

|113 = FLT INJ 2 |Faulty injection cardiac output wave for 2 degrees.|

| |Computational constant is 0.561. |

|114 = L- T SHT 2 |Left to right shunt cardiac output wave for 2 |

| |degrees. Computational constant is 0.561. |

|115 = FLT INJ 20 |Faulty injection cardiac output wave for 20 |

| |degrees. Computational constant is 0.608. |

|116 = L- R SHT 20 |Left to right shunt cardiac output wave for 20 |

| |degrees. Computational constant is 0.608. |

|117 = CAL WAVES |Calibrated cardiac output waves. |

|118 = NONCAL WVE |Uncalibrated cardiac output waves. Gives 4 |

| |different values per 3, 5, and 7 L/min waves. |

|119 = CAL 1 SEC |Calibration pulse of 1 degree for 1 second. |

|120 = CAL 4 SEC |Calibration pulse of a delta of 402 Ohms for 4 |

| |seconds. |

|121 = SET BT 37C |37 °C / 98.6 °F |

|122 = SET BT 36C |36 °C / 95.9 °F |

When the monitor under test indicates that it is ready to perform a Cardiac Output calculation, press enter on the PS-420/440 to generate a test. The 4 second calibration pulse provides a delta change of 402 Ohms. This provides a standard for testing cardiac output units.

If any cardiac output waveform key is selected a second time while a waveform is proceeding, the selected waveform will stop. The blood temperature will return to 37 °C / 98.6 °F.

5 ECG Performance Testing

Square Wave.

|Code = Display |Sets: |

| | |

|128 = 2 Hz SQR |2.0 Hz square waveform. |

|129 = .125 Hz SQ |0.125 Hz square waveform. |

Triangle Wave.

|Code = Display |Sets: |

| | |

|130 = 2 Hz TRIAN |2.0 Hz triangle waveform. |

|131 = 2.5 Hz TRI |2.5 Hz triangle waveform |

Pulse Wave.

|Code = Display |Sets: |

| | |

|132 = PULSE 30 |Pulse of 30 BPM, width of 60 mS. |

|133 = PULSE 60 |Pulse of 60 BPM, width of 60 mS. |

Sine Wave.

|Code = Display |Selects: |

| | |

|135 = SINE .5 Hz | 0.5 Hz sine wave. |

|136 = SINE 5 Hz | 5.0 Hz sine wave. |

|137 = SINE 10 Hz | 10.0 Hz sine wave. |

|138 = SINE 40 Hz | 40.0 Hz sine wave. |

|139 = SINE 50 Hz | 50.0 Hz sine wave. |

|140 = SINE 60 Hz | 60.0 Hz sine wave. |

|141 = SINE 100Hz | 100.0 Hz sine wave. |

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Cable Connection Matrices

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

[pic]

2 PS-320 Agilent 50 Series – Ultrasound Cable

[pic]

3 PS-320 Agilent 50 Series Toco – External Cable

[pic]

4 PS-320 Agilent 50 Series Toco – IUP Cable

[pic]

5 PS-320 Agilent 8040 Toco – IUP Cable

[pic]

6 PS-320 Corometrics – Ultrasound Cable

[pic]

7 PS-320 Corometrics Toco – External Cable

[pic]

8 PS-320 Corometrics Toco – IUP Cable

[pic]

Codes and Descriptions

1 Keypad Control

2 Two-Function Keys

The following keys have two functions. They are numeric keys for keying in preset codes. They are also one-step selection keys for scrolling through certain preset codes.

Preset Codes

Temperature Cable Connection Matrices

1 PS-420/440 Temperature Cable – YSI 400 Series

2 PS-420/440 Temperature Cable – YSI 700 Series

3 PS-420/440 Temperature Cable – HP-YSI 400 Series

4 PS-420/440 Universal Temperature Cable - Unterminated

Cardiac Output Cable Connection Matrices

1 COA-G Cardiac Output Adapter

Simulator: PS-420, PS 440

2 COA-HP Cardiac Output Cable – Monitor Type: HP

Simulator: PS-420, PS 440

3 COA-1 Cardiac Output Cable – YSI 400 Series

Simulator: PS-420, PS 440

4 COA-2 Cardiac Output Cable – YSI 700 Series

Simulator: PS-420, PS 440

Blood Pressure Cable Connection Matrices

1 PS-420/440 BP Cable – Monitor Type: GE-2

Marquette Medical (GE) – PDS-3100

2 PS-420/440 BP Cable – Monitor Type: GE-3

Marquette Medical (GE) – PDS-3000

3 PS-420/440 BP Cable – Monitor Type: HP-1

Hewlett Packard – 78200 (Twinax)

4 PS-420/440 BP Cable – Monitor Type: HP-2

Hewlett Packard – 7809 (5 pin)

5 PS-420/440 BP Cable – Monitor Type: HP-3

Hewlett Packard – 78-300, -500, -800 Merlin (12 pin 5 µV)

6 PS-420/440 BP Cable – Monitor Type: HP-4

Hewlett Packard – 78-300, -500, -800, Merlin (12 pin 40 µV)

7 PS-420/440 BP Cable – Monitor Type: HP-8

Hewlett Packard – 8040A, M1350A (12 pin 40 µV) (IUP)

8 PS-420/440 BP Cable – Monitor Type: HP-9

Hewlett Packard – 8040A, M1350A (12 pin 5 µV) (IUP)

9 PS-420/440 BP Cable – Monitor Type: KT-1

Kontron Medical – Mini-, Super-, Color-Mon Series

10 PS-420/440 BP Cable – Monitor Type: LT-1

Advanced Medical Systems – FM 660, FM 670 (IUP)

Airshields – Fetascan 1400 (IUP)

11 PS-420/440 BP Cable – Monitor Type: MM-1

Mennen Medical – All

12 PS-420/440 BP Cable – Monitor Type: MQ-2

Marquette Medical – 7000/TRAM (round)

13 PS-420/440 BP Cable – Monitor Type: MQ-3

Marquette Medical – Eagle series (rectangular) TRAM Scope

14 PS-420/440 BP Cable – Monitor Type: NK-1

Nihon Kohden – All

15 PS-420/440 BP Cable – Monitor Type: PB-2

Datex – Cardiocap

Puritan Bennett – PB-240

16 PS-420/440 BP Cable – Monitor Type: PC-1

Medical Data Electronics – Escort Series

17 PS-420/440 BP Cable – Monitor Type: SL-1

Spacelabs – ALPHA 9/703R

18 PS-420/440 BP Cable – Monitor Type: SM-1

Siemens – Sirecust Series

19 PS-420/440 BP Cable – Monitor Type: SM-3

Siemens – Micor/Mingo (15 pin)

20 PS-420/440 BP Cable – Monitor Type: TK-1

Criticare Systems, Inc. – 1100 / Criticon – 8700 / Invivo Researsch – Omni-Trak / Ivy Biomedical – All North American Drager – Vitalert 2000 / Protocol Series – Propaq Series 100 / Spacelabs – 400/5008600PCMS/90-300, -600, -700, PC-Express

21 PS-420/440 Universal Pressure Cable – Unterminated

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PS-420/440 RS-232 Cable Connection Matrix

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|USA |FRANCE |NORWAY |

|1345 Monroe NW, Suite 255A |30, rue Paul Claudel |Travbaneveien 1 |

|Grand Rapids, MI 49505 |91000 Evry, France |N-7044 Trondheim, Norway |

|Phone: (+1) 888 863-8766 |Phone: (+33) 1 6078 8899 |Phone: (+47) 7382 8500 |

|Fax: (+1) 616 454-3350 |Fax: (+33) 1 6078 6839 |Fax: (+47) 7391 7009 |

|E-mail: support.us@metron- |E-mail: info@metron.fr |E-mail: support@metron.no |

|[pic] |

|From: (name) |      |Phone: |      | |

|Address: |      |Fax: |      | |

| |      |E-mail: |      | |

| |      |Date: |      | |

| | | | | |

|Error Report |

|Product: |      |Version: |      |Serial no.: |      |

| | | |

|Description of the situation prior to the error:       |

|Description of the error:       |

|(METRON AS internally) |

|Comments: |

|      |

|Received date:       |Correction date:       |Ref No.       | Critical | Normal | Minor |

|USA |FRANCE |NORWAY |

|1345 Monroe NW, Suite 255A |30, rue Paul Claudel |Travbaneveien 1 |

|Grand Rapids, MI 49505 |91000 Evry, France |N-7044 Trondheim, Norway |

|Phone: (+1) 888 863-8766 |Phone: (+33) 1 6078 8899 |Phone: (+47) 7382 8500 |

|Fax: (+1) 616 454-3350 |Fax: (+33) 1 6078 6839 |Fax: (+47) 7391 7009 |

|E-mail: support.us@metron- |E-mail: info@metron.fr |E-mail: support@metron.no |

|[pic] |

|From: (name) |      |Phone: |      | |

|Address: |      |Fax: |      | |

| |      |E-mail: |      | |

| |      |Date: |      | |

| | | | |

|Improvement Suggestion |

|Product: |      |Version: |      |

| | | |

|Description of the suggested improvement:       |

|(METRON AS internally) |

|Comments: |

|      |

|Received date:       |Correction date:       |Ref No.       | Critical | Normal | Minor |

|USA |FRANCE |NORWAY |

|1345 Monroe NW, Suite 255A |30, rue Paul Claudel |Travbaneveien 1 |

|Grand Rapids, MI 49505 |91000 Evry, France |N-7044 Trondheim, Norway |

|Phone: (+1) 888 863-8766 |Phone: (+33) 1 6078 8899 |Phone: (+47) 7382 8500 |

|Fax: (+1) 616 454-3350 |Fax: (+33) 1 6078 6839 |Fax: (+47) 7391 7009 |

|E-mail: support.us@metron- |E-mail: info@metron.fr |E-mail: support@metron.no |

[pic]

-----------------------

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.

Revision 2

NOTE

Only use the enter key when scrolling through the current settings. Using a menu scroll or change key interrupts the scrolling operation.

NOTE

Remove the batteries and disconnect the AC Adapter / Battery Eliminator if you do not intend to use the PS-420/440320 for an extended period of time.

Revision 2

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