Carestream DENTAL RVG 142 User manual

Safety, Regulatory and Technical Specications User Guide
RVG 142, RVG 5200 & RVG 6200

2 RVG 142, RVG 5200 and RVG 6200 Safety, Regulatory User Guide (SM847) Ed06
N ot ic e
The Regulatory Information & Technical Specification User Guide for RVG 142, RVG 5200 and
RVG 6200 includes information on the safety instructions, regulatory information and the technical
specifications of the device. We recommend that you thoroughly familiarize yourself with this
Guide to make the most effective use of your system.
The information 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 permission of Carestream Dental
LLC.
U.S. Federal law restricts this device to sale by or on the order of a dentist or physician.
This document is originally written in English.
Manual Name: RVG 142, RVG 5200 and RVG 6200 Safety, Regulatory and Technical
Specification User Guide
Part Number: SM847
Revision Number: 06
Print Date: 2020-10
RVG 142, RVG 5200 and RVG 6200 comply with Directive 93/42/EEC relating to medical
equipment.

RVG 142, RVG 5200 and RVG 6200 Safety, Regulatory User Guide (SM847) Ed06 3
Contents
1Safety Information ................................................................... - 4 -
Indications for Use ....................................................................................................... - 4 -
Conventions in this Guide ........................................................................................... - 4 -
Warning and Safety Instructions ................................................................................ - 5 -
Hygiene and Disinfection ............................................................................................. - 6 -
Cleaning the Sensor Head .............................................................................. - 6 -
Cleaning the Sensor Cable ............................................................................. - 6 -
Cleaning and Disinfecting Positioning Accessories ................................... - 6 -
Cleaning the RVG Connect Unit ..................................................................... - 7 -
Marking and Labeling Symbols .................................................................................. - 8 -
Label Locations ............................................................................................................ - 9 -
2Regulatory Information ......................................................... - 10 -
General Regulatory Information ............................................................................... - 10 -
Compliance With International Regulations ............................................................ - 14 -
3Technical Specification ......................................................... - 15 -
Factory ......................................................................................................................... - 15 -
Manufacturer ............................................................................................................... - 15 -
Model ........................................................................................................................... - 15 -
RVG 142, RVG 5200 and RVG 6200 Technical Specifications ............................... - 16 -
RVG Connect Technical Specification ..................................................................... - 17 -
Minimum Computer System Requirements ............................................................. - 18 -
Imaging Performance Information ............................................................................ - 18 -
Controlling the Image Quality ................................................................................... - 18 -
Environmental Requirements ................................................................................... - 19 -
4 Contact Information .............................................................. - 20 -
Manufacturer’s Address ............................................................................................ - 20 -
Factory ......................................................................................................................... - 20 -
Authorized Representatives ...................................................................................... - 20 -

4 RVG 142, RVG 5200 and RVG 6200 Safety, Regulatory User Guide (SM847) Ed06
1 Safety Information
Indications for Use
The RVG 142, RVG 5200 and RVG 6200 digital intra-oral X-ray sensors are intended to produce
an image of the dental area at the direction of dentists, oral surgeons and orthodontists for X-ray
imaging of the dento-maxillofacial area.
RVG 142, RVG 5200 and RVG 6200 transmit an acquired image to a computer 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 connected to the LAN (Local Area
Network).
Conventions in this Guide
The following special messages emphasize information or indicate potential risk to personnel or
equipment:
WARNING: Warns you to avoid injury to yourself or others by following
the safety instructions precisely.
Important: Alerts you to a condition that might cause problems.
Note: Emphasizes important information.
Tip: Provides extra information and hints.

RVG 142, RVG 5200 and RVG 6200 Safety, Regulatory User Guide (SM847) Ed06 5
Warning and Safety Instructions
WARNINGS:
Device
• Read and understand this safety information before using RVG 142, RVG 5200
and RVG 6200.
• You are responsible for the operation and maintenance of this device. Only
legally qualified persons can operate this device. They MUST have training to
use the device. When necessary, have a trained authorized service technician
carry out inspection and maintenance operations.
• Install this device in an X-ray room that complies with current installation
standards. From this location, you must be able to maintain visual or audio
communication with the patient and be able to access the Acquisition Interface
module during exposure.
• Do NOT operate the device if there is the threat of an earthquake. Following an
earthquake, ensure that the device is operating satisfactorily before using it
again. Failure to observe this precaution may expose patients to hazards.
• X-ray equipment is hazardous to patients and the operator if you do not observe
the exposure safety factors and operating instructions.
• To dispose of the device or its components, contact a service technician.
• No modification of this device is allowed.
• Do NOT use this device in conjunction with oxygen-rich environments. This
device is not intended for use with flammable 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 must cover the RVG sensor
before placing it in the patient’s mouth.
• To prevent cross-contamination, use a new hygienic barrier for each new
patient and disinfect the RVG sensor.
• To ensure the best quality images, you must connect the RVG sensor to a USB
port on the BACK of the workstation.
• RVG Connect: the management and the allocation of the static IP address
must be done by a network administrator.
• RVG Connect: For the smooth functioning of the image recovery mechanism,
do NOT switch off the RVG Connect unit and do NOT disconnect the ethernet
cable from the RVG Connect unit.
• Place the sensor in the patient mouth ONLY if the RVG icon is green on the
imaging software.
• If you find that the RVG sensor is too hot, disconnect the RVG sensor and
contact an authorized service technician.
Computer
• RVG 5200 or RVG 6200 or RVG 142 shall be supplied by Low Voltage-Low Power
(<15W) source separated from the mains by DI/RI Isolation (Double isolation /
Reinforced isolation). The USB port of a computer or the hub is separated from
the mains by DI/RI Isolation.
• See your computer installation guide for details of the data processing system
and screen. Leave a sufficient amount of clear space around the CPU to ensure
that it is properly ventilated.
• Always use Microsoft Windows Update to make sure that the latest security
patches are correctly installed.

6 RVG 142, RVG 5200 and RVG 6200 Safety, Regulatory User Guide (SM847) Ed06
Hygiene and Disinfection
Cleaning the Sensor Head
WARNINGS:
•Disinfect the sensor head after each patient.
•Never place the sensor in an autoclave as this could result in serious damage to
the sensor.
•Do not use UV disinfection nor ultrasound cleaning as this could result in
serious damage to the sensor.
•Do not move the sensor using its cable when you remove the protective
hygienic sleeves.
•You must first clean the RVG sensor before disinfecting it.
•You must use the disinfectant according to the manufacturer instructions.
You must first clean the RVG sensor before disinfecting it. To do so, follow these steps:
1. Remove the protective hygienic sleeves.
2. Remove debris or organic matter from the sensor surfaces with a disposable wipe or surface
brush.
3. Inspect the sensor for debris. Repeat cleaning if there is any debris left.
4. Disinfect the sensor head with disinfecting 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 compound with alcohol, a
phenolics, an iodophors, an EPA-registered chlorine-base product). You must follow the
manufacturer instructions for use.
Cleaning the Sensor Cable
The cable must be cleaned with disposable disinfecting wipes with intermediate-level hospital
disinfectant with label claims of tuberculocidal activity.
Cleaning and Disinfecting Positioning Accessories
Positioning Accessories Daily Maintenance Tasks
Accessory
Maintenance Tasks
RVG Holder
Cleaning the RVG Holder
You must clean the RVG sensor holder before you disinfect it.
To clean the sensor holder, follow these steps:
1. Remove all debris and organic matter with a disposable wipe.
2. Rinse under running water.
3. Using a soft brush, scrub with warm taps water and soap or
detergent.
4. Rinse under running water.
5. Dry with compressed air or hygienic disposable cloth.
6. Visually inspect the RVG sensor holder for residual debris.
Repeat steps 1 to 5 if you see residual debris.

RVG 142, RVG 5200 and RVG 6200 Safety, Regulatory User Guide (SM847) Ed06 7
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.

8 RVG 142, RVG 5200 and RVG 6200 Safety, Regulatory User Guide (SM847) Ed06
Marking and Labeling Symbols
Type BF device symbol complying with the IEC 60601-1 standard.
In 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 information on the collection and
recovery programs available for this product.
Warning
Refer to instruction manual/booklet
Date of Manufacture.
Manufacturer’s address.

RVG 142, RVG 5200 and RVG 6200 Safety, Regulatory User Guide (SM847) Ed06 9
Label Locations
The following figures illustrate the label locations 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 Connect unit label
N° EBJL0003
EBJL0003
Type: CIC33
Date: 2019/02/16
DDJI0020
RVG Connect
Carestream Dental, LLC
Input: 48-56V 0.25A
DDJI0020

10 RVG 142, RVG 5200 and RVG 6200 Safety, Regulatory User Guide (SM847)
Ed06
2 Regulatory Information
General Regulatory Information
Compliance with European and International Standards
EN 60601-1/IEC 60601-1
Medical Electrical Equipment, Part 1: General requirements
for basic safety and essential performance
EN 60601-1-2/IEC 60601-1-2
Medical Electrical Equipment, Part 1-2: General
requirements for basic safety and essential performance -
Collateral Standard: Electromagnetic Disturbances –
Requirements and tests.
EN 60601-1-6/IEC 60601-1-6
Medical Electrical Equipment, Part 1-6: General
requirements for basic safety and essential performance –
Collateral 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 15223-1
Medical devices - Symbols to be used with medical device
labels, labeling and information to be supplied - Part 1:
General requirements
EN 1041
Information supplied by the manufacturer of medical devices
EN 62304/IEC 62304
Medical device software - Software life cycle processes
EN ISO 10993-1
Biological evaluation of medical devices - Part 1: Evaluation
and testing within a risk management process
CAN/CSA C22.2 N°60601-1
Medical Electrical Equipment – Part 1: General
Requirements for basic safety and essential performance
ANSI/AAMI ES60601-1
Medical Electrical Equipment – Part 1: General
Requirements for basic safety and essential performance