Instructions For Use (En); Intended Use - RaySafe i3 Mode D'emploi

INSTRUCTIONS FOR USE (EN)

Intended use

RaySafe i3 is designed for personal use on hospital staff. It measures scattered
radiation in examination rooms using a dosimeter, and shows a graphical visualization
of dose rate in real time on a display.
Usage
The RaySafe i3 system needs to be installed and initiated before use. This can be
done by a service technician, using the instructions in the printed Installation and
Service Manual, delivered with the system.
Use the dosimeter on the outside of your X-ray protection garment. Front forward, clip
towards your body.
The Real-time Dosimeter (A in Figure "1." on page 2) measures scattered radiation
and stores measurements. When a dosimeter is exposed to radiation while connected
to a Real-time Hub (B in Figure "1." on page 2), measurements are transferred
from dosimeter to hub via radio. A display shows dose rate bars in real time in green,
yellow or red, from low to high dose rate (C in Figure "1." on page 2).
To view dose history stored in the dosimeter, connect the dosimeter to a computer
running Dose Viewer (D in Figure "1." on page 2). See the Dose Viewer manual,
found in the help menu in Dose Viewer. Optional analysis software: Dose Manager (E
in Figure "1." on page 2).
CAUTION! The Real-time Dosimeter measures scattered radiation and should
neither be positioned in the primary X-ray field nor be used for
diagnostic measurements.
WARNING! RaySafe i3 does not replace any X-ray protection equipment.
WARNING! RaySafe i3 is not sterile.
WARNING! RaySafe i3 is not a replacement for legal dosimeters.
Maintenance
The Real-time Dosimeter has a replaceable battery. When a red light is flashing on the
side of the dosimeter, the battery needs to be replaced. A service technician can do
this, using the instructions in the Installation and Service Manual.
For cleaning of the dosimeter, use a damp cloth and mild detergent.
Specifications
Physical
Real-time Dosimeter
Weight 34 g (1.2 oz)
Dimensions 40 × 58 × 17 mm
(1.6 × 2.3 × 0.7 in)
Power Replaceable battery:
CR2450 Li/MnO
2
Video
output
Radiology
Operational quantity
Energy dependence
Temperature dependence
Response time
Integration interval
Detection limit
Dose rate uncertainty (continuous
radiation)
The measured dose rate is monotonically increasing up to 1 Sv/h.
Dose reproducibility
Maximum lifetime dose
Typical angular response
(relative to 0°)
Typical energy response
Real-time Hub dose unit
Real-time Hub Video Unit
180 g (6.3 oz) 282 g (9.9 oz)
184 × 134 × 35 mm 108 × 83 × 24 mm
(11.8 × 9.8 × 2.4 in) (4.3 × 3.3 × 0.9 in)
Power over Ethernet: External supply:
GT-963003648-T3-PP EA1024PR
DVI Digital output:
2x HDMI 1.4a up to
1920×1200 @60Hz
H (10)
p
< 25 % (N-series, 40 – 150 kV)
< 5 % (18 – 26 °C)
< 25 % (15 – 18 °C, 26 – 35 °C)
< 1 s (> 100 μSv/h), < 5 s (< 100 μSv/h)
1 s
< 30 μSv/h
10 % or 10 μSv/h (40 μSv/h – 150 mSv/h),
20 % (150 – 300 mSv/h),
40 % (300 – 500 mSv/h)
10 % or 1 μSv
10 Sv
Vertical: Figure "2." on page 2
Horizontal: Figure "3." on page 2
Figure "4." on page 2
Sv or rem
Radio
Real-time Dosimeter
Frequency 868.3 MHz, 918.3 MHz or 927.9 MHz, depending on
purchased configuration (see label on product)
Transmitter power output 3.2 mW
Communication range Typically 5 – 15 m, depending on the local environment
Climatic conditions
Temperature
Temperature rate of change
Relative humidity
IP code
For safe usage
Always power off the dosimeter before air transport, to make sure that the radio
communication is completely turned off.
Security and privacy
Dosimeter serial number as well as name and settings entered via Dose Viewer are
sent unencrypted via radio to the Real-time Hub.
Symbols on labels
Symbol Meaning
Manufacturer
Manufacturer
Manufacturer
Manufacturer
Manufacturer
Manufacturer
Date of manufacture
Date of manufacture
Date of manufacture
Date of manufacture
Date of manufacture
Date of manufacture
Article number
Catalogue number
Catalogue number
Catalogue number
Catalogue number
Catalogue number
Serial number Serial number
Serial number
Serial number
Serial number
Serial number
Consult the instructions for
Consult the instructions for
Consult the instructions for use.
Consult the instructions for
Consult the instructions for
Consult the instructions for
Caution
Caution
Caution
Caution
Conforms to European Union directives.
Caution
CCC Mark
Electrical safety compliance marking, together with listing number
CCC Mark
CCC Mark
CCC Mark
CCC Mark
("Appendix" on page 14)
LOT Mark / Batch
LOT Mark / Batch
LOT Mark / Batch
Radio certification number for US market
LOT Mark / Batch
LOT Mark / Batch
/FCC
("Appendix" on page 14)
IC Radio certification number for Canadian market
("Appendix" on page 14)
Radio certification symbol and number for Brazilian market
("Appendix" on page 14)
Conforms to relevant Australian Safety and EMC standards.
Radio certification symbol and number for Japanese market
R
In the European Union the WEEE directive and label indicates that
when discarding this product, it must be sent to separate collection
facilities for recovery and recycling. For advice and information,
contact RaySafe.
None of the China RoHS restricted substances are present above
permitted levels.
Learn more
• Real-time Dosimeter quick guide under the lid of the dosimeter packaging
• Dose Viewer manual via the Help button in Dose Viewer
• Installation and Service manual delivered with the system
Service and support contacts
For information about service and support, visit www.raysafe.com.
3
RaySafe i3 – Instructions for Use (EN)
Real-time Hub
1 mW
+15 – +35 °C (for operation)
–25 – +70 °C (for storage)
< 0.5 °C/minute
20 – 80 % (for operation)
5 – 95 % (for storage)
Real-time Dosimeter: IP20
Real-time Hub: IP20