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RVG 142, RVG 5200 and RVG 6200 Safety, Regulatory User Guide (SM847) Ed06 

RVG Holder (continued)  Disinfecting the RVG Holder 

WARNINGS: 

You must use medical autoclaving equipment

cleared by the FDA in the USA or one that is

recognized by your Local Authority.

DO NOT use a chemical autoclave to disinfect the

RGV sensor holder.

You must always follow the operating    parameters

recommended by the manufacturer of the

autoclaving equipment.

Use FDA-cleared or CE-marked standard packaging

material.

To disinfect the RVG sensor holder after cleaning it, follow these 

steps: 

1. Steam autoclave at 134° C (273° F) for 3 minutes using distilled

water.

2. Leave to dry before use.

WARNING: Avoid direct contact with the metallic part 

of the autoclave.

 

Arm and Ring 

Disinfecting the Arm and Ring 

To disinfect the arm and ring, follow these steps: 

1. Disassemble the metal arm and the plastic ring.

2. Remove any residue from components with hot water and

soap.

3. Put components in disinfection pouches, and place in the

middle tray of the autoclave, away from autoclave walls and

heating element. Plastic parts must be in a separate pouch than

metal arms, to avoid melting or warping.

4. Steam autoclave at 132°C (270°F) for 10 minutes before the

next patient.

Do not exceed 134°C (273°F).

Do NOT use phenol-based glutaraldehyde.

Do NOT use special application or ultrasonic cleaners.

Do NOT CHEMICLAVE or DRY-HEAT STERILIZE.

Do NOT cold sterilize

Note: Plastic parts have a limited life and should 

be replaced periodically. Any method of 

sterilization will shorten the life of plastic parts.

 

Cleaning the RVG Connect Unit 

The RVG Connect unit must be cleaned with disposable disinfecting wipes with 

intermediate-level hospital disinfectant with label claims of tuberculocidal activity. 

Summary of Contents for RVG 142

Page 1: ...Safety Regulatory and Technical Specifications User Guide RVG 142 RVG 5200 RVG 6200...

Page 2: ...formation contained in this guide may be subject to modification without notice justification or notification to the persons concerned No part of this guide may be reproduced without the express permi...

Page 3: ...7 Marking and Labeling Symbols 8 Label Locations 9 2 Regulatory Information 10 General Regulatory Information 10 Compliance With International Regulations 14 3 Technical Specification 15 Factory 15 M...

Page 4: ...puter using a USB cable To do so they require additional components such as conventional extra oral X ray source and imaging software In addition RVG 6200 can be used with an RVG Connect unit connecte...

Page 5: ...anesthetics or flammable agents It is not recommended to use accessories other than those specified in this document and sold by Carestream Dental Single use disposable protective hygienic sleeves mus...

Page 6: ...g wipes or soak it in a disinfecting solution with intermediate level hospital disinfectant with label claims of tuberculocidal activity for example a chlorine containing product a quaternary ammonium...

Page 7: ...To disinfect the arm and ring follow these steps 1 Disassemble the metal arm and the plastic ring 2 Remove any residue from components with hot water and soap 3 Put components in disinfection pouches...

Page 8: ...n the European Union this symbol indicates Do NOT discard this product in a trash receptacle use an appropriate recovery and recycling facility Contact your local sales representative for additional i...

Page 9: ...cations of RVG 5200 RVG 6200 and RVG Connect Figure 1 RVG 142 RVG 5200 RVG 6200 sensor box label Figure 2 RVG 142 RVG 5200 and RVG 6200 USB cable label Figure 3 RVG 142 product label Figure 4 RVG Conn...

Page 10: ...ral Standard Usability EN 62366 IEC 62366 Medical devices Application of usability engineering to medical devices EN ISO 14971 Medical devices Application of risk management to medical devices EN ISO...

Page 11: ...ing to the EMC information provided in this document Communication Equipment Portable and mobile Radio Frequency RF communications equipment can affect the Electromagnetic Compatibility of RVG 142 RVG...

Page 12: ...e Electromagnetic Environment Guidance RF emissions CISPR 11 Group 1 RVG 142 RVG 5200 and RVG 6200 use RF energy only for their internal function Therefore their RF emissions are very low and are not...

Page 13: ...IEC 61000 4 2 8 kV contact 15 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient...

Page 14: ...tations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagn...

Page 15: ...and RVG 6200 Safety Regulatory User Guide SM847 Ed06 15 3 Technical Specification Factory TROPHY 4 rue F Pelloutier Croissy Beaubourg 77435 Marne la Vall e Cedex 2 France Manufacturer Model RVG 5200...

Page 16: ...Size 1 1168 x 1562 pixels Size 2 1402 x 1874 pixels Sensor active surface dimensions Size 1 22 2 x 29 6 mm Size 2 26 6 x 35 5 mm Gray scale 4096 grey levels 12 bits Dimension Size 1 27 6 mm W x 37 7 m...

Page 17: ...echnical Specification Components Specification RVG Connect Ethernet interface 100 BaseT USB connector Receptacle Type A USB Interface USB 2 0 high Speed Power supply interface Power Over Ethernet POE...

Page 18: ...based board with 256 MB of RAM Display 1024 x 768 minimum screen resolution 32 bits color mode Operating system Windows 10 64 bits USB 2 0 2 ports available Ethernet 100 BaseT CD DVD drive DVD ROM dr...

Page 19: ...ing Conditions Temperatures 10 40 C Relative humidity 30 85 Atmospheric pressure 700 1060 hpa Altitude Up to 3000 m Storage Conditions Temperatures 10 60 C Relative humidity 10 90 Atmospheric pressure...

Page 20: ...urg 77435 Marne la Vall e Cedex 2 France Authorized Representatives Authorized Representative in the European Community Authorized Representative in Brazil CARESTREAM DENTAL BRASIL EIRELI Rua Romualdo...

Page 21: ...e Guide de s curit de r glementation et de sp cifications techniques destin l utilisateu Manuale per l utente di specifiche tecniche normative e di sicu ezza Gua del usuario de las especificaciones tc...

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