RaySafe i2 User Manual Oct 2014

© 2014.10 Unfors RaySafe 5001047-4.1 All rights are reserved. Reproduction or transmission in whole or in part, in any form or by any means, electronic, mechanical or otherwise, is prohibited without the prior written consent of the copyright owner.

RaySafe i2 System User Manual – Contents

CONTENTS INTRODUCTION... 5 About the RaySafe i2 System... 5 How the system works... 6 About this user manual... 6 USING THE DOSIMETER... 7 Introduction... 7 Getting started... 7 USING THE CRADLE... 8 Introduction... 8 Getting started... 8 USING DOSE VIEWER AND DOSE MANAGER... 9 USING THE REAL TIME DISPLAY... 10 GETTING STARTED... 10 Real time display features... 11 Shutting down the real time display ... 23 MAINTENANCE... 24 Calibrating the real time display screen... 24 Synchronize dose history to a USB memory... 24 Cleaning and disinfection... 24 TROUBLESHOOTING... 26 Real time display... 26 Dose viewer, dose manager and cradle... 26 Other user manuals... 27 IMPORTANT INFORMATION ABOUT THE SYSTEM... 28 Intended use of the RaySafe i2 System... 28 Compatibility... 29 Technical documentation... 29 Compliance... 29 Training ... 29

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RaySafe i2 System User Manual – Contents System requirements... 30 TECHNICAL DATA... 31 Dosimeter radiology ... 31 Dosimeter memory ... 31 Real time display memory ... 32 Dose data transfer from dosimeter to real time display ... 32 Dosimeter and real time display/dose viewer memories ... 32 Time management... 33 Technical Specifications ... 33 Climatic conditions... 36 Security and privacy requirements ... 37 SAFETY... 38 Important safety directions... 38 Electrical safety... 39 Mechanical safety... 39 Explosion safety... 39 Fire safety ... 40 Electrostatic discharge (ESD)... 40 Electromagnetic Compatibility (EMC)... 41 Modality specific safety... 42 Network safety, security and privacy... 43 Toxic or hazardous substances and elements ... 43 Equipment label overview ... 43 PRODUCT DISPOSAL... 48 Introduction... 48 Passing the system on to another user... 48 Final disposal of the system... 48

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RaySafe i2 System User Manual – Introduction

INTRODUCTION ABOUT THE RAYSAFE i2 SYSTEM

Figure 1.

RaySafe i2 System overview

The RaySafe i2 System can contain the following components: •

dosimeter

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real time display

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dose viewer (computer software)

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dose manager (computer software)

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cradle (dock station used to connect dosimeters and computer)

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dosimeter rack (dosimeter storage)

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RaySafe i2 System User Manual – Introduction

HOW THE SYSTEM WORKS The dosimeter measures and records X-ray exposure every second and transfers the data wirelessly, via radio, to the real time display. The real time display shows real time dose exposure from up to eight dosimeters in range at a time. Color indication bars (green, yellow, red) represents the intensity of the currently received exposure. The accumulated dose per individual is displayed next to the color indication bars. By tapping a dosimeter name the user can look at historical data in separate views. When the dosimeter is not in use, it should be stored in the dosimeter rack, away from the real time display. More detailed historical dose information can be transferred from dosimeters via the cradle connected to a computer and viewed using the computer software (dose viewer and dose manager). The dose viewer software is also used for administrating dosimeters, change dosimeter names, colors and reset dose history. The dose manager software is an advanced software for analyzing, reporting and archiving dose information. It handles multiple dosimeters and can retrieve the dose information from multiple real time displays through the hospital network or via USB storage.

ABOUT THIS USER MANUAL This user manual are intended to assist users in the safe and effective operation of the product described. Before attempting to operate the product, you must read these instructions for use, noting and strictly observing all WARNINGS and CAUTION notices. WARNING A WARNING alerts you to a potential serious outcome, adverse event or safety hazard. Failure to observe a warning may result in death or serious injury to the operator or patient. CAUTION

A CAUTION alerts you to where special care is necessary for the safe and effective use of the product. Failure to observe a caution may result in minor or moderate personal injury or damage to the product or other property, and possibly in a remote risk of more serious injury, and/or cause environmental pollution.

NOTE

Notes highlight unusual points as an aid to an operator.

These Instructions for Use describe the most extensive configuration of the product, with the maximum number of options and accessories. Not every function described may be available on your product.

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RaySafe i2 System User Manual – Using the Dosimeter

USING THE DOSIMETER

Figure 2. The dosimeter

INTRODUCTION The dosimeter is an active dose meter designed for maintenance-free usage throughout its lifetime. You can personalize the dosimeter’s appearance by attaching one of the 8 inlays of different color, which are delivered together with the dosimeter. (Select which color to show on the real time display, using the dosimeter options dialog in dose viewer or dose manager.) The dosimeter measures staff dose. The optimal usage for the dosimeter to measure dose is to use it unshielded from any X-ray protection garment.

GETTING STARTED Follow the instructions below to start using your dosimeter: 1. Make sure that the dosimeter’s power mode is set to on. (Use dose viewer or dose manager to set dosimeter power mode.) 2. Attach the dosimeter on your clothes, front forward, using the clip, which is located on the back of the dosimeter, or the lanyard holder that is provided with the dosimeter. The dosimeter now records dose values and transmits them to real time displays within range. You can also read out the recorded dose values by using dose viewer via the cradle (see dose viewer user manual). See the chapter “Technical Specifications” on page 33 to learn more about dosimeter memory and data transfer between dosimeter and real time displays.

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RaySafe i2 System User Manual – Using the cradle

USING THE CRADLE

Figure 3. The cradle

INTRODUCTION The cradle is a dock station that lets you connect a dosimeter to a computer for data read out as well as dosimeter Options writing into the dosimeter. Use the cradle in combination with the dose viewer and/or dose manager applications.

GETTING STARTED NOTE

Do not connect the cradle to the computer unless dose viewer and the cradle driver are installed on the computer.

1. Start the dose viewer/dose manager application. 2. Connect a cradle to your computer’s USB port. 3. Put a dosimeter in the cradle. Within a few seconds, dose viewer/dose manager will detect the dosimeter. This is indicated at the top of the main window by a note “Connected to dosimeter 100001158”, where dosimeter 100001158 is an example of a dosimeter ID. Dose viewer/dose manager will start loading the dosimeter dose history. This may take up to a few minutes. You can follow the progress on the progress bar at the bottom of the main window.

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RaySafe i2 System User Manual – Using dose viewer and dose manager

USING DOSE VIEWER AND DOSE MANAGER See dose viewer and dose manager user manuals, found in the help menu in the dose viewer and dose manager software.

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RaySafe i2 System User Manual – Using the real time display

USING THE REAL TIME DISPLAY INTRODUCTION The real time display is the display unit in the RaySafe i2 system. It communicates wireless with dosimeters within radio range in order to collect, present and store dosimeter dose data.

Figure 4. The real time display. WARNING The distance from which the real time display detects a dosimeter depends on the settings that the service engineer made during the installation.

GETTING STARTED STARTING THE REAL TIME DISPLAY 1. Connect the output connector of the power adapter to the back of the real time display,. 2. Connect the input connector to a grounded electrical outlet socket. This will switch on the real time display. WARNING To avoid the risk of electric shock, the real time display must only be connected to a supply mains with protective earth. First a start up screen will be displayed for a few seconds and after 30 seconds the system is ready to use. The online view will display a maximum of 8 dosimeters at a time. Only dosimeters that are in range of the real time display will be displayed.

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RaySafe i2 System User Manual – Using the real time display The real time display screen is a touch screen. Operate the real time display by tapping buttons and graphs on the screen. NOTE

Dosimeters are shown on a first come first serve principle (see “Reserved slots menu” in section “Admin Settings menu” on page 20). dosimeters that are not shown in the Online View still measure and store dose data.

WARNING Do not cover the real time display to prevent excessive temperatures. WARNING Be careful when moving other equipment in the vicinity of the real time display.

REAL TIME DISPLAY FEATURES The real time display offers: •

An online view (see section “Online view – view current dose rates” on page 12) where you can: •

view current personal dose rate information for up to eight dosimeters at a time.

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access the personal dose overview by tapping the displayed name tag button of that dosimeter in the online view.

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A personal dose overview (see section “Personal dose overview – view detailed dose data” on page 14) where you can view historical dose data for a dosimeter chosen from the online view.

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A real time display settings view (see section “Real time display settings view” on page 18) for administrator settings.

See the “Technical data” on page 31 for technical details about how the real time display displays dose data. In addition, the real time display: •

Serves as an interim storage for the dosimeters’ dose data to be further analyzed in the optional dose manager application.

•

Is provided with a USB port for dose data download to USB memory (see “Synchronize dose history to a USB memory” on page 24). NOTE

When the real time display memory is full, the oldest data will be overwritten with newer data. For storage capacity examples, see section “Real time display memory” on page 32.

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RaySafe i2 System User Manual – Using the real time display

ONLINE VIEW – VIEW CURRENT DOSE RATES

Figure 5. The online view NOTE

Dosimeters are shown on a first come first serve principle (see “reserved slots menu” in section “Admin Settings menu” on page 20). Dosimeters that are not shown in the online view still measure and store dose data (see “Dosimeter memory” on page 31).

The icon in the upper left corner gives you access to the real time display settings view (see section “Real time display settings view” on page 18). The accumulated dose per examination column shows the accumulated dose since last tap on the reset button in the lower right corner. The accumulated dose per examination will also be reset when restarting the real time display. NOTE

The accumulated dose per examination is only recorded in the real time display memory. The values recorded in the dosimeter is not affected.

NOTE

When resetting the accumulated dose per examination, values of all dosimeters with connection to that display will be affected, not only the ones currently visible.

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RaySafe i2 System User Manual – Using the real time display

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Figure 6. The online view elements LEGEND 1

Personal dose overview (see page 14) access (tap anywhere on the white bar)

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Scale, green zone

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Scale, yellow zone

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Scale, red zone

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Accumulated procedure dose

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Peak dose rate indication

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Displayed name

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Displayed symbol (color of the dosimeter)

The displayed name identifies the dosimeters. It may be truncated due to lack of space. By tapping the white bar of a dosimeter, you will enter the personal dose overview of that dosimeter. The dose rate scale is divided in three zones: •

Green zone indicates < 0.2 mSv/h (< 0.02 rem/h).

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Yellow zone indicates 0.2 – 2 mSv/h (0.02 – 0.2 rem/h). If you are exposed to radiation in the yellow zone frequently, you should take actions to minimize the dose exposure.

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Red zone dose indications 2 – 20 mSv/h (0.2 – 2 rem/h) and should not occur often during normal procedures. If you are exposed to radiation in the red zone frequently, you should take actions to minimize the dose exposure.

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RaySafe i2 System User Manual – Using the real time display When a dosimeter moves out of range of the real time display, its button will remain visible in the online view for three minutes. This feature allows people to temporarily leave the room without loosing their position in the list. If no dosimeter has been within range of the real time display for 30 minutes, the online view will enter screen saver mode. In screen saver mode the real time display displays a black screen. The real time display screen starts up when a dosimeter connects to the real time display or when the user taps the screen.

PERSONAL DOSE OVERVIEW – VIEW DETAILED DOSE DATA

Figure 7.

Dose overview

Enter the personal dose overview of a dosimeter by tapping the displayed name button of that dosimeter in the online view. On the left hand side of the dose overview a dosimeter info panel is displayed (see figure above). It displays: •

Full Name

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Displayed Name – the name that is displayed in the real time display Online View

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Clinical Role – Doctor, Nurse, Technician or Other

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Dosimeter Position – Head, Torso, Hand, Belly, Leg or Other

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RaySafe i2 System User Manual – Using the real time display •

Dosimeter – a unique ID per dosimeter

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Battery status

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2-4 blocks indicate normal state.

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1 block indicates that the dosimeter needs to be replaced.

The dosimeter’s date and time

The Personal dose overview has two sub views: •

the annual dose view (see section “Annual dose” on page 16)

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the personal dose history view (see section “Dose history” on page 17)

1

2

2

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Figure 8. The personal dose overview – access to sub views When you enter the personal dose overview you will see the following information to the right: •

The annual dose since January 1st of the current year, or since last reset. This value is also shown as a percentage of the yearly max dose.

•

Access to the annual dose sub view (1), see section “Annual dose” on page 16.

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RaySafe i2 System User Manual – Using the real time display •

Dose session 1 and 2 values, date and time. Use the dose sessions to measure dose for specific time spans, for example a specific procedure or a working day. The value shows the accumulated dose for a session since last dose session reset. Use the reset buttons (2) to reset a dose session to zero. Information about dose session reset will appear as an event in the dose manager software.

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Total personal dose since the last dose history reset.

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The current day’s personal dose history graph. You can also access the personal dose history sub view (3), see section “Dose history” on page 17.

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A notification area with editable contact information (see section “Real time display name and location menu” on page 20), if applicable. ANNUAL DOSE

Figure 9. The annual dose view In this screen you can find the following information: •

Today’s date (vertical line).

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Annual dose limit (red line). Set this value in dose viewer or dose manager.

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RaySafe i2 System User Manual – Using the real time display •

The annual dose limit distributed over the full year (dashed line). As long as the accumulated dose stays below this value, the annual dose limit will not be exceeded for the full year.

•

Accumulated dose in relation to the annual dose limit for the current year (green/orange line). When the accumulated dose exceeds the distributed annual dose limit, the color will change from green to orange in order to alert the user to take actions. NOTE

The annual dose limit for the dosimeter is dependent of the shielding factor of the lead apron, as well as other radiation protection used. The more protection the higher the limit can be for the same effective dose to the user. The annual dose limit may or may not be chosen to reflect the legal dose limit where it is used. It could reflect the legal limit or for example a lower target for the clinical user case.

DOSE HISTORY

Figure 10. The dose history view, with day selected In this view, you can view hour, day and week overviews by tapping the respective buttons on top of the screen. In the hour time span you can view a dose rate graph spanning ½ hours. Each data point in the graph represents the maximum dose rate during the surrounding 15 seconds.

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RaySafe i2 System User Manual – Using the real time display In the day/week time spans you can view accumulated dose value bars. Each bar represents the accumulated dose during one/four hours, respectively. Within the day and week time spans, tapping a dose bar in the diagram will zoom into the larger underlying time scale (that is week -> day and day -> hour). Within each time span (hour/day/week) you can step forward and backward in time with the arrow buttons on the bottom of the screen. By pressing and holding the arrow buttons you will scroll along the time axis within the chosen zoom level. NOTE

Switching between hour, day and week will set the view to the current date and time.

In the upper left corner of the chart, the value of the accumulated dose during the chosen time span is visible.

REAL TIME DISPLAY SETTINGS VIEW The real time display settings view is where administrators configure the real time display. Follow the instructions below to enter the real time display settings view: 1. Tap the settings menu symbol in the upper left corner of the online view. 2. Enter configuration values by tapping the buttons in the respective menus In the lower part of real time display settings, the real time display ID/serial number and the software version is displayed. This information can be used as assistance for support issues.

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RaySafe i2 System User Manual – Using the real time display USER SETTINGS MENU

Figure 11. The user settings menu The user settings menu consists of one screen. Adjust the backlight level of the screen by moving the arrow horizontally. This change will take effect immediately.

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RaySafe i2 System User Manual – Using the real time display ADMIN SETTINGS MENU The Admin Settings menu consists of four screens. Access these screens by tapping the arrow buttons in the lower right corner of each screen. Real time display name and location menu

Figure 12. The real time display name and location menu Enter name and location of the real time display. This information is used to identify the real time display so that it can be detected in dose manager. Enter service contact name and number to your local RaySafe i2 system manager. The service contact information will appear in the notification area, on the left side in the personal dose overview.

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