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RaySafe i3 – 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

Real-time Hub

Video Unit

Weight

34 g (1.2 oz)

180 g (6.3 oz)

282 g (9.9 oz)

Dimensions 40 × 58 × 17 mm  

(1.6 × 2.3 × 0.7 in)

184 × 134 × 35 mm 
(11.8 × 9.8 × 2.4 in)

108 × 83 × 24 mm 
(4.3 × 3.3 × 0.9 in)

Power

Replaceable battery: 
CR2450 Li/MnO

2

Power over Ethernet: 
GT-963003648-T3-PP

External supply: 
EA1024PR

Video 
output

DVI Digital output: 
2x HDMI 1.4a up to 
1920×1200 @60Hz

Radiology

Operational quantity

H

p

(10)

Energy dependence

< 25 % (N-series, 40 – 150 kV)

Temperature dependence

< 5 % (18 – 26 °C) 
< 25 % (15 – 18 °C, 26 – 35 °C)

Response time

< 1 s (> 100 μSv/h), < 5 s (< 100 μSv/h)

Integration interval

1 s

Detection limit

< 30 μSv/h

Dose rate uncertainty (continuous 
radiation)

10 % or 10 μSv/h (40 μSv/h – 150 mSv/h), 
20 % (150 – 300 mSv/h), 
40 % (300 – 500 mSv/h)

The measured dose rate is monotonically increasing up to 1 Sv/h.
Dose reproducibility

10 % or 1 μSv

Maximum lifetime dose

10 Sv

Typical angular response 
(relative to 0°)

Vertical:

 

Figure “2.” on page 2 

 

Horizontal:

 

Figure “3.” on page 2

Typical energy response

Figure “4.” on page 2

Real-time Hub dose unit

Sv or rem

Radio

Real-time Dosimeter

Real-time Hub

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

1 mW

Communication range

Typically 5 – 15 m, depending on the local environment

Climatic conditions

Temperature

+15 – +35 °C (for operation) 
–25 – +70 °C (for storage)

Temperature rate of change

< 0.5 °C/minute

Relative humidity

20 – 80 % (for operation) 
5 – 95 % (for storage)

IP code

Real-time Dosimeter: IP20 
Real-time Hub: IP20

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

Date of manufacture

Catalogue number

Serial number

Consult the instructions for 

Caution

CCC Mark

LOT Mark / Batch

Manufacturer

Manufacturer

Date of manufacture

Catalogue number

Serial number

Consult the instructions for 

Caution

CCC Mark

LOT Mark / Batch

Date of manufacture

Manufacturer

Date of manufacture

Catalogue number

Serial number

Consult the instructions for 

Caution

CCC Mark

LOT Mark / Batch

Article number

Manufacturer

Date of manufacture

Catalogue number

Serial number

Consult the instructions for 

Caution

CCC Mark

LOT Mark / Batch

Serial number

Manufacturer

Date of manufacture

Catalogue number

Serial number

Consult the instructions for 

Caution

CCC Mark

LOT Mark / Batch

Consult the instructions for use.

Conforms to European Union directives.

Electrical safety compliance marking, together with listing number 
(“Appendix” on page 14)

/FCC

Radio certification number for US market 
(“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.

R

Radio certification symbol and number for Japanese market

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.

INSTRUCTIONS FOR USE (EN)

Summary of Contents for i3

Page 1: ...E 4 INSTRUCCIONES DE USO ES 5 MODE D EMPLOI FR 6 ISTRUZIONI PER L USO IT 7 使用説明書 日本語 8 BRUKSANVISNING NO 9 GEBRUIKSAANWIJZING NL 10 INSTRUÇÕES DE USO BRPT 11 BRUKSANVISNING SV 12 使用说明 简体中文 13 APPENDIX 14 EU DECLARATION OF CONFORMITY 15 RaySafe i3 with on screen display ...

Page 2: ...0 6 0 4 0 2 0 0 0 2 0 4 0 6 0 8 1 0 1 2 1 4 20 30 40 50 60 70 80 90 100 110 120 130 keV 1 2 3 4 2019 10 Unfors RaySafe 5001122 1 00 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 C A B D E ...

Page 3: ...1 Sv h Dose reproducibility 10 or 1 μSv Maximum lifetime dose 10 Sv Typical angular response relative to 0 Vertical Figure 2 on page 2 Horizontal Figure 3 on page 2 Typical energy response Figure 4 on page 2 Real time Hub dose unit Sv or rem Radio Real time Dosimeter Real time Hub Frequency 868 3 MHz 918 3 MHz or 927 9 MHz depending on purchased configuration see label on product Transmitter power...

Page 4: ...reproduzierbarkeit 10 oder 1 μSv Maximale Lebensdauerdosis 10 Sv Typische Winkelabhängigkeit relativ zu 0 Vertikal Abbildung 2 auf Seite 2 Horizontal Abbildung 3 auf Seite 2 Typische Energieabhängigkeit des Ansprechvermögens Abbildung 4 auf Seite 2 Echtzeit Hub Dosiseinheit Sv oder rem Funkkommunikation Echtzeit Dosimeter Echtzeit Hub Frequenzen 868 3 MHz 918 3 MHz oder 927 9 MHz je nach gekaufter...

Page 5: ...áxima de por vida 10 Sv Respuesta angular típica en relación con 0 Vertical Figura 2 en la página 2 Horizontal Figura 3 en la página 2 Respuesta de energía normal Figura 4 en la página 2 Unidad de dosis del concentrador en tiempo real Sv o rem Radio Dosímetro en tiempo real Concentrador en tiempo real Frecuencia 868 3 MHz 918 3 MHz o 927 9 MHz según la configuración adquirida véase la etiqueta en ...

Page 6: ...eproductibilité des doses 10 ou 1 μSv Dose biochronique maximale 10 Sv Réponse angulaire typique par rapport à 0 Verticale Figure 2 on page 2 Horizontale Figure 3 on page 2 Réponse énergétique typique Figure 4 on page 2 Unité de dose du Hub en temps réel Sv ou rem Radio Dosimètre en temps réel Hub en temps réel Fréquence 868 3 MHz 918 3 MHz ou 927 9 MHz selon la configuration achetée voir étiquett...

Page 7: ...monotonamente fino a 1 Sv h Riproducibilità della dose 10 o 1 μSv Dose massima a vita 10 Sv Risposta angolare tipica relativa a 0 Verticale Figura 2 a pagina 2 Orizzontale Figura 3 a pagina 2 Risposta energetica tipica Figura 4 a pagina 2 Unità di dose dell hub in tempo reale Sv o rem Radio Dosimetro in tempo reale Hub in tempo reale Frequenza 868 3 MHz 918 3 MHz o 927 9 MHz a seconda della config...

Page 8: ...v 最大寿命線量 10 Sv 標準的な角度応答 0 に対して 垂直 図ページ2の 2 水平 図ページ2の 3 標準的なエネルギー 応答 図ページ2の 4 リアルタイムハブ線 量単位 Svまたはレム ラジオ リアルタイム線量計 リアルタイムハブ 周波数 購入した構成に応じて868 3 MHz 918 3 MHz 927 9 MHz 製品のラベルを参照 トランスミ ッタの電源出力 3 2 mW 1 mW 通信範囲 通常 ローカル環境に応じて5 15 m 気候条件 温度 15 35 C 作業 25 70 C 保管 変化の温度速度 0 5 C 分 相対湿度 20 80 作業 5 95 保管 IPコード リアルタイム線量計 IP20 リアルタイムハブ IP20 安全な使用方法 無線通信が完全にオフになっていることを確認するために 航空輸送の前 は常に線量計の電源をオフにして ください セキュリティと...

Page 9: ... forhold til 0 Vertikalt Figur 2 på side 2 Horisontalt Figur 3 på side 2 Typisk energirespons Figur 4 på side 2 Sanntidskoblingspunktets doseenhet Sv eller rem Radio Sanntidsdosimeter Sanntidskoblingspunkt Frekvens 868 3 MHz 918 3 MHz eller 927 9 MHz avhengig av kjøpt konfigurasjon se etikett på produkt Senderens utgangseffekt 3 2 mW 1 mW Kommunikasjonsrekkevidde Typisk 5 15 m avhengig av det loka...

Page 10: ...mSv h De gemeten stralingsbelasting neemt lineair toe tot 1 Sv h Dosisreproduceerbaarheid 10 of 1 μSv Maximale stralingsbelasting in een mensenleven 10 Sv Gangbare hoekreactie ten opzichte van 0 Verticaal afbeelding 2 op pagina 2 Horizontaal afbeelding 3 op pagina 2 Gangbare energiereactie Afbeelding 4 op pagina 2 Dosiseenheid Real time Hub Sv of rem Radio Real time Dosimeter Real time Hub Frequen...

Page 11: ...ular típica em relação a 0 Vertical Figura 2 na página 2 Horizontal Figura 3 na página 2 Resposta energética típica Figura 4 na página 2 Unidade de dose do Real time Hub Sv ou rem Rádio Real time Dosimeter Real time Hub Frequência 868 3 MHz 918 3 MHz ou 927 9 MHz dependendo da configuração comprada ver etiqueta no produto Saída de energia do transmissor 3 2 mW 1 mW Alcance de comunicação Tipicamen...

Page 12: ...1 μSv Maximal livstidsdos 10 Sv Typiskt vinkelsvar relativt 0 Lodrätt figur 2 på sidan 2 Vågrätt figur 3 på sidan 2 Typiskt energisvar Figur 4 på sidan 2 Dosenhet för Real time Hub Sv eller rem Radio Real time Dosimeter Real time Hub Frekvens 868 3 MHz 918 3 MHz eller 927 9 MHz beroende på anförskaffad konfiguration se produktens etikett Sändarens uteffekt 3 2 mW 1 mW Kommunikationsområde Typiskt ...

Page 13: ...0 Sv 典型的角度响应 相对于 0 垂直 图 第 2 页中的 2 水平 图 第 2 页中的 3 典型的能量响应 图 第 2 页中的 4 实时集线器剂量单位 Sv 或 rem 无线电特性 实时剂量计 实时集线器 频率 868 3 MHz 918 3 MHz 或 927 9 MHz 取决于 购买的配置 请参阅产品标签 发射机功率输出 3 2 mW 1 mW 通信范围 通常为 5 15 米 具体取决于当地环境 气候条件 温度 15 35 C 操作温度 25 70 C 存储温度 温度变化率 0 5 C 分钟 相对湿度 20 80 操作湿度 5 95 存储湿度 IP 代码 实时剂量计 IP20 实时集线器 IP20 安全使用说明 在空运之前务必关闭剂量计 以确保无线电通信完全切断 安全和隐私 剂量计序列号以及通过剂量查看器输入的名称和设置会通过无线电以不 加密的方式发送到实时集线器 标签上的符号 ...

Page 14: ...er or an experienced radio TV technician for help This portable device with its antenna is excluded from SAR testing since the output power is below the SAR test exclusion threshold The antenna used for this device must not be co located or operating in conjunction with any other antenna or transmitter Changes or modifications not expressly approved by the party responsible for compliance could vo...

Page 15: ...15 RaySafe i3 Instructions for Use EU DECLARATION OF CONFORMITY ...

Page 16: ...d Standard covering the essential requirement of article 3 1 b of Directive 2014 53 EU and the essential requirements of article 6 of Directive 2014 30 EU EMC ETSI EN 301 489 3 Electromagnetic Compatibility RED and EMC V2 1 1 EMC standard for radio Directive equipment and services Part 3 Specific conditions for Short Range Devices SRD operating on frequencies between 9 kHz and 246 GHz Harmonised S...

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