PatSim200 Instruction Manual Version 1.1 Dec 2016

Rigel Medical 5 year Warranty Statement To activate your 5 year warranty register your product at the below link. Terms and conditions apply. www.rigelmedical.com/5years Calibration Statement The PatSim200 Patient Simulator is fully calibrated and found to be within the specified performance and accuracy at the time of production. The Seaward Group provides its products through a variety of channels; therefore it may be possible that the calibration date on the provided certificate may not represent the actual date of first use. Experience has indicated that the calibration of this instrument in not effected by storage prior to receipt by the user. We therefore recommend that the recalibration period be based on a 12 month interval from the first date the unit is placed in to service. For information on service or calibration please go to the below link. www.rigelmedical.com/calibration

Date received into service;

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© Copyright 2016 All rights reserved. Nothing from this edition may be multiplied, or made public in any form or manner, either electronically, mechanically, by photocopying, recording, or in any manner, without prior written consent from the SEAWARD GROUP. This also applies to accompanying drawings and diagrams. Due to a policy of continuous development the SEAWARD GROUP reserves the right to alter the equipment specification and description outlined in this publication without prior notice and no part of this publication shall be deemed to be part of any contract for the equipment unless specifically referred to as an inclusion within such contract.

Disposal of old product

The PatSim200 Patient Simulator has been designed and manufactured with high quality materials and components, which can be recycled and reused. Please familiarise yourself with the appropriate local separate collection system for electrical and electronic products or contact your local supplier for further information. Please dispose of this product according to local regulations. Do not dispose of this product along with normal waste material. By offering your old products for recycling, you will help prevent potential negative consequences for the environment and human health.

User Notes These operating instructions are intended for the use of adequately trained personnel. Important, follow the documentation! This symbol indicates that the operating instructions must be adhered to in order to avoid danger. If the PatSim200 is used in a manner not specified by the manufacturer, the protection provided by the equipment may be impaired. This product contains a lithium ion battery: Do not disassemble, crush, or puncture a battery Do not short the external contacts on a battery Do not dispose of a battery in fire or water Do not expose a battery to temperatures above 60 °C (140 °F) Keep the battery away from children Avoid exposing the battery to excessive shock or vibration Do not use a damaged battery If a battery pack has leaking fluids, do not touch any fluids. Dispose of a leaking battery pack

Index 1

2

3

4

5

Introduction ... 4 1.1

Getting to know your PatSim200 ... 4

1.2

In the box... 5

1.3

Additional & Optional Accessories ... 5

1.4

Charging... 5

1.5

Battery Status ... 6

1.6

Powering On/Off... 6

1.7

Screen Brightness... 7

Getting Started ... 8 2.1

Setup ... 8

2.2

About... 9

2.3

Favourite Simulations ... 10

Simulation Settings ... 13 3.1

ECG Settings ... 14

3.2

Respiration Settings ... 22

3.3

Temperature Settings ... 23

3.4

Invasive blood pressure settings ... 24

Maintaining the PatSim200 ... 26 4.1

Cleaning the PatSim200 ... 26

4.2

User Maintenance ... 26

Technical Specifications ... 28

Appendix A - IBP cable wiring diagram ... 32 Appendix B - Temperature cable wiring diagram ... 33

1 Introduction The PatSim200 from Rigel was designed to make every patient simulation quicker. Unlike other Patient Simulators, the PatSim200 uses a home and recall function to easily move between tests and store your most used sequences, no more clicking and scrolling through 'tree style' hierarchy to perform each test. The handheld PatSim200 is capable of the below simulations: •

• • •

ECG o ECG wave forms o Arrhythmia’s o Performance Waveform o Pacer Waveforms o Fetal Maternal Respiration Temperature Invasive blood pressure (2 channel)

The PatSim200 forms part of a comprehensive range of high performance specialist biomedical test equipment supplied by Rigel Medical, part of the Seaward Group. For further information go to www.rigelmedical.com

1.1 Getting to know your PatSim200

1.2 In the box

• • • • • •

Quick start guide Universal USB Power Supply 10 x Applied Part Adaptors Calibration Certificate PatSim 200 Simulator PatSim 200 carry case

1.3 Additional & Optional Accessories Replacement Battery Temperature Cable (unterminated) IBP Cable (unterminated) Replacement Carry Case Applied Part Adaptors Universal USB Power Supply

404A954 404A955 404A956 404A950 404A951 404A952

1.4 Charging

The PatSim200 is supplied with a universal USB charger. You should only use the supplied charger with your PatSim200. Whilst the charger is connected to the unit and energised, the LED light on the top right of the top fascia will be illuminated. Note: The LED does not indicate the charging status.

Whilst the PatSim200 is powered on you will also see the below symbols on the display.

Bulk Charging

Trickle charging The PatSim200 may be used whilst charging however displayed signal quality may be reduced on some monitor types.

1.5 Battery Status During normal use, the PatSim200 automatically checks the battery status and shows the closest representation using the symbols below.

Fully charged

Battery empty When the battery is completely empty the unit will warn the user that it is about to turn off before shutting down.

1.6 Powering On/Off Turn your PatSim200 on or off by pressing and holding the ’Rigel’ button for 3 seconds.

1.7 Screen Brightness You can change the screen brightness on the PatSim200 to make it suitable for different environments. To change the screen brightness press the left or right arrow keys in the home screen.

2 Getting Started 2.1 Setup In the PatSim200 you have the option to change the language, temperature units and auto off time of the unit. Pressing the Rigel key in any menu will take you to the Settings screen.

Here you can use the up & down arrow keys to highlight Local Settings and press the select (tick) button.

You can then use the up & down arrow keys to highlight the parameter you wish to change and then use the left & right arrow keys to select your preferred setting. There is a fast key on F5 to switch between °C & °F. Pressing Home or Back will automatically save these settings. The settings will remain even when the unit is powered down and back on.

Available Settings Language

Temperature Auto Off

English German French Spanish Polish Simplified Chinese °C °F Off 2 min 5 min 10 min 30 min 60 min

2.2 About From the Settings screen you can view information about the tester. Highlight About using the up and down arrow keys and press the select (tick) button. This will show you information on when the unit was last calibrated, the serial number, hardware and firmware versions.

To leave this screen you can press the back button to go back to the settings menu or the Home button to go back to the Home screen.

2.3 Favourite Simulations You can save up to 5 of your most used simulation settings for recall at any time. 2.3.1

Default settings

The unit will be delivered with 5 default settings as detailed below.

2.3.2

Adding a new favourite setting

Pressing the Rigel key in any menu will take you to the Settings screen.

Here you can hold down one of the function keys for 3 seconds to save the current settings to that memory location. You will see a messaging asking if you are sure.

Press the cross on F1 to go back to the settings screen. Press the tick on F5 for yes and the tester will display a message of Saving Settings and then Settings Saved before returning to the home screen.

2.3.3

Recalling a favourite setting

Pressing the Rigel key in any menu will take you to the Settings screen.

Here you can press one of the 5 function keys to access the corresponding settings. You will see a messaging asking if you are sure.

Press the cross on F1 to go back to the settings screen. Press the tick on F5 for yes and the tester will go to the home screen with the relevant settings selected.

3 Simulation Settings The PatSim200 is capable of the below simulations: •

• • •

ECG o ECG wave forms o Arrhythmia’s o Performance Waveform o Pacer Waveforms o Fetal Maternal Respiration Temperature Invasive blood pressure (2 channel)

A list of the full settings available for each simulation is available at the end of each section. Upon power-up, the user is presented with the Home screen which shows the Simulation Menu on F keys 1-4 and a summary of the settings saved on memory location 1.

3.1 ECG Settings Pressing F1 from the home screen takes you to the ECG menu. The screen shows the current settings.

Note: All ECG waveform images are representations specifically for Lead II 3.1.1

Normal Sinus Rhythm

Pressing F1 in the ECG menu takes you to the Normal Sinus Rhythm screen. The screen will show the current settings. You can then use the up & down arrow keys to highlight the parameter you wish to change and then use the left & right arrow keys to select your required setting.

Pressing F3 changes between adult and neonatal settings.

You can see which is currently selected by which figure is in green on the right hand of the screen.

Pressing F5 shows a visual representation of the waveform you should expect to see on the monitor with the current settings.

To leave any of these screens you can press the back button to go back to the previous menu or the Home button to go back to the Home screen. Available Normal Sinus Rhythm Simulations Rates Amplitude (lead II) ST Segments

30, 40, 50, 60, 70, 80, 90, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 BPM 0.05 mV to 0.45 mV (0.05 mV steps) 0.5 mV to 5.5 mV (0.5 mV steps) -0.8 mV to +0.8 mV in 0.1 mV steps and +0.05mV and -0.05mV on Lead II

3.1.2

Arrhythmias

Pressing F2 in the ECG menu takes you to the Arrhythmias screen. You can then use the up & down arrow keys to highlight the type of arrythmia you wish to simulate and the select (tick) key to select. Alternatively you can use the function keys as fast keys to select the corrosponding arrythmia type.

You can then use the left and right arrow keys to highlight the specific arrythmia you wish to simulate. Press down to hilight the amplitude and the left and right arrows to select the setting you wish to use.

Pressing F5 shows a visual representation of the waveform you should expect to see on the monitor with the current settings.

To leave any of these screens you can press the back button to go back to the previous menu or the Home button to go back to the Home screen. Available Arrhythmia Settings VENTRICULAR

SUPRAVENTRICULAR

ATRIAL CONDUCTION

PREMATURE

Asystole Bigeminy Trigeminy Ventricular Fibrillation (coarse) Ventricular Fibrillation (fine) Ventricular Tachycardia Atrial Fibrillation coarse Atrial Fibrillation fine Atrial Flutter Atrial Tachycardia Missing beat Nodal rhythm Paroxysmal Atrial Tachycardia Sinus Arrhythmia Supraventricular Tachycardia First Degree AV Block Left Bundle Branch Block Right Bundle Branch Block Second Degree AV Block - Mobitz I Second Degree AV Block - Mobitz II Third Degree AV Block Premature Atrial Contraction Premature Nodal Contraction Premature Left Ventricle Contraction Premature Left Ventricle Contraction - early Premature Left Ventricle Contraction - R on T Premature Right Ventricle Contraction Premature Right Ventricle Contraction - early

Amplitude (lead II)

3.1.3

Premature Right Ventricle Contraction - R on T Premature Ventricular Contraction - 6 / min Premature Ventricular Contraction – 12 / min Premature Ventricular Contraction - 24 / min Premature Ventricular Contraction – frequent multifocal 0.05 mV to 0.45 mV (0.05 mV steps) 0.5 mV to 5.5 mV (0.5 mV steps)

Performance Waveform

Pressing F3 in the ECG menu takes you to the Performance Waveform screen. The screen will show the current settings. You can then use the up & down arrow keys to highlight the parameter you wish to change and then use the left & right arrow keys to select your required setting.

Pressing F5 shows a visual representation of the waveform you should expect to see on the monitor with the current settings.

To leave any of these screens you can press the back button to go back to the previous menu or the Home button to go back to the Home screen.

Available Performance Waveforms Sine Waves Square Waves Pulse Triangle Wave Performance amplitude

3.1.4

0.05, 0.5, 1, 10, 25, 30, 40, 50, 60, and 100 Hz 0.125, 2 Hz 60bpm or 240bpm 2 Hz 0.5 to 5.0 mV in 0.5 mV steps

Pacer Waveforms

Pressing F4 in the ECG menu takes you to the Pacer Waveforms screen. The screen will show the current settings. You can then use the up & down arrow keys to highlight the parameter you wish to change and then use the left & right arrow keys to select your required setting.

Pressing F3 takes you to the R-Wave Detection menu. You can then use the up & down arrow keys to highlight the parameter you wish to change and then use the left & right arrow keys to select your required setting.