Trident RiX-70 DC - User Manual

User Manual
RiX 70 DC
i
User Manual
RiX-70 DC
X-Ray Intraoral System
Date: 19/01/2017
Language: English
Rev: 2
Code: UM04-EN
0051

Summary

Introduction to the RiX-70 DC System

User Recommendations and Safety

Carefully read and follow the warnings and safety instructions contained in the User's Manual.

Device Classification and Unit Description

Details about the RiX-70 DC unit and its classification as an active medical device per IEC standards.

Technical Specifications of RiX-70 DC

System Supply and Power Requirements

Technical specifications for the system's power supply, including voltage, frequency, current, and fuse.

X-Ray Head and Tube Technical Data

Specifications for the X-ray head, tube voltage, anode current, and output radiation characteristics.

Component Weights

Lists the weights of various components of the RiX-70 DC system and its package.

Operating Instructions for RiX-70 DC

Control Panel Overview

Overview of the RiX-70 DC control panel, its buttons, and indicator lights.

Additional Keypad and Beam Limiting Device

Description of the additional keypad and beam limiting device for system adjustments and positioning.

System Operation and Exposure

Step-by-step guide for operating the RiX-70 DC, including parameter selection and exposure process.

Pre-set Exposure Time Tables

Tables detailing pre-set exposure times for various tooth types, patient sizes, and receptors.

Care and Maintenance Procedures

Cleaning and Disinfection Guidelines

Instructions for cleaning and disinfecting the unit, emphasizing safety and proper materials.

Scheduled Maintenance and Servicing

Information on regular maintenance by service technicians and operator checks.

Disposal of Obsolete Equipment

Electromagnetic Compatibility (EMC)

Electromagnetic Emissions

Information on EMC compliance and guidance for electromagnetic emissions from the device.

Electromagnetic Immunity

Details on immunity tests and EMC environment guidance for the device.

RF Communication Separation Distances

Guidelines for maintaining minimum distances between RF transmitters and the device to prevent interference.

System Configurations

Wall Mounted Version Components

Lists and illustrates the components of the wall-mounted version of the RiX-70 DC system.

Mobile Stand Version Components

Lists and illustrates the components of the mobile stand version of the RiX-70 DC system.

Appendix B: System Icons

Icon Descriptions

Table explaining various symbols used in the user manual and their meanings.

Appendix C: Heating and Cooling Curves

Graphical Performance Data

Graphical representations of heating and cooling curves for the X-ray tube and monoblock.

Appendix D: Troubleshooting Alarms

Error Codes and Solutions

Lists error codes, their descriptions, and potential causes/solutions for the RiX-70 DC system.

Appendix E: Component Labels

Label Identification Guide

Explains the various labels on the RiX-70 DC unit, including unit identification, X-ray tube, and arm.

Overview

1. Function Description
2. Important Technical Specifications
3. System Supply
4. X-Ray Head
5. X-Ray Tube
6. Weights
7. Usage Features
8. Control Panel Functions
9. Operation Steps
10. Beam Limiting Device
11. Pre-set Exposure Times
12. Maintenance Features
13. Care and Cleaning
14. Disinfecting
15. Maintenance Schedule
16. Electromagnetic Compatibility (EMC)
17. Disposing of Obsolete Equipment

The RiX-70 DC is an intraoral X-ray system designed for taking images of the oral cavity. It utilizes ionizing radiation (X-rays) and is developed with high technology to produce high-quality images, compatible with both traditional films and digital image receptors (intraoral sensors and phosphor plates). This system is available in two versions: wall-mounted and mobile.

Function Description:

The RiX-70 DC is an electro-medical device intended for diagnostic imaging of the oral cavity. It emits X-rays to capture detailed images, aiding in dental examinations and diagnoses. The system is built for continuous operation with intermittent load, requiring users to observe usage cycles to allow for heat dissipation from the radiation source. It is classified as a Class I device, Type B, conforming to IEC 60601-2-65:2012. According to EC Directive 93/42 and its amendments, it is an active medical device that releases ionizing radiation and poses a potential hazard to the human body, thus requiring use under the supervision of a doctor or a person with extensive experience in radiology.

Important Technical Specifications:

System Supply:

• Voltage: AC100-240 V
• Frequency: 50/60 Hz
• Electric current: 2-1 A (@240V), 5.5 A (@110V)
• Max power consumption: 640 VA
• Fuse: 6.3 AT
• Connection: 7 wires cable with double insulation

X-Ray Head:

• Tube Voltage: 60 kVp ± 8%, 65 kVp ± 8%, 70 kVp ± 8%
• Anode current: 7 mA ± 10%
• Output radiation linearity: < 0.2 seconds IEC 60601-2-63
• Duty cycle: 1:30
• Nominal power: 490 W (70 kVp - 7 mA)
• Total filtration: 1.5 mm Al eq. @ 70 kVp
• Current transformer insulation: Oil bath
• Cooling: As per convention
• Focal spot: 0.4 mm (IEC 60336)
• Leakage radiation at 1 m: < 1 mGy/h
• Max thermal capacity of monoblock: 130 kJ
• Distance focus to skin: 20 cm
• Beam diameter X-Ray at 200 mm focus: 60 mm
• Beam limiting device (additional): Rectangular 36 x 45 mm
• Dose intensity accuracy: < 50%

X-Ray Tube:

• Manufacturer: Toshiba (Japan) / CEI (Italy)
• Model: D-045 / OX70-4
• Inherent filtration: < 1 mm Al eq. / 0.5 mm Al eq.
• Target angle: 12.5° / 16°
• Filament current: Max. 3 A / 1.5 - 2.1 A
• Max filament current: 3 V / 1.7 - 3.1 V
• Anodic thermal capacity: 4.3 kJ / 7 kJ
• Max anodic dissipation: 100 W / 110 W
• X-RAY beam covering at 200 mm from the focus: ≥ 70 mm
• Focal spot: 0.4 IEC 60336:2005
• Target material: Tungsten
• Max nominal voltage: 70 kV

Weights:

• Timer: 4.00 kg
• Support arm 60 cm: 1.7 kg
• Support arm 80 cm: 4.5 kg
• Support arm 100 cm: 5.5 kg
• Scissor arm: 11.4 kg
• Tube head: 4.3 kg
• Mobile stand base: 24 kg
• Mobile stand column: 4.00 kg
• Wall mounted version with 80 cm arm support: 25 kg
• Mobile version: 45 kg
• Package: 112 x 36 x h32.5 cm, Weight: 27 kg

Usage Features:

The RiX-70 DC features a user-friendly control panel and an additional keypad near the tube head for adjusting exposure time, tooth type, and patient size.

Control Panel Functions:

• System ready: Green light indicates the system is ready.
• Emission in progress: Yellow light indicates X-ray emission.
• Alarm: Red light indicates a system problem, potentially interrupting emission.
• +/- Buttons: Manually increase/decrease preset values.
• Tooth Type selection: Allows selection of specific teeth (lower incisors, canines, bicuspids, molars; upper molars, bicuspids, canines, teeth, bitewing) for examination.
• Patient size selection: Choose between adult or child based on patient morphology.
• Image receptor selection: Select the receptor type from film, intraoral sensor, and phosphor plate.
• kV selection: Allows selection of voltage (60, 65, and 70 kVp).
• X-RAY button Activation: Initiates a countdown on the display, allowing for exposures by pressing the X-Ray button.
• Menu: Pressing for at least 2 seconds accesses the User's Menu for less frequently adjusted parameters.

Operation Steps:

1. Turn on the device using the switch below the timer. An automatic auto-diagnosis will run, displaying the software version and then the last exposure parameters.
2. Select the desired kVp (60, 65, or 70 kVp) using the kVp button.
3. Choose the image receptor (film, intraoral sensor, or phosphor plate) by touching the "Image Receptor Selection" symbol. The display will show the selected symbol and, for analog receptors, the film sensitivity.
4. Select patient size (large/small) and tooth type by touching the corresponding symbols.
5. The system automatically selects the output time based on the chosen parameters. This exposure time is displayed and can be adjusted manually using the "+" or "-" buttons.
6. Position the patient, ensuring they wear a protective lead apron (not supplied by Trident Dental).
7. Orient the tube-head and image receptor as needed, with the collimator's rim in contact with the film holder or patient's face to minimize blur.
8. Move to a safe position at least 2 meters from the patient with the exposure hand-switch.
9. Press and hold the exposure pushbutton. A yellow light indicates X-ray emission. Keep it pressed until the yellow light turns off, signaling the end of exposure. Releasing the button prematurely will terminate radiation and trigger an alarm.
10. Hook back the hand-switch and process the image receptor.

Beam Limiting Device:

This device is suitable for both bisecting and paralleling radiographic techniques. It should be angled appropriately, and its rim kept in touch with the film holder or patient's face to reduce blur from movement during irradiation. To use the rectangular collimator, the correct setting must be selected from the User's Menu.

Pre-set Exposure Times:

The RiX-70 DC calculates default exposure times based on image quality evaluation. These values depend on user preference (contrast, brightness, etc.) and patient mouth anatomy. Manual adjustment of exposure times is possible in 47 steps from 0.010 to 2 seconds.

Maintenance Features:

Care and Cleaning:

• Always disconnect the unit from the power supply before cleaning.
• Clean painted surfaces, accessories, and connection cables by hand with a damp cloth and mild detergent. Ensure no liquids enter the equipment.
• Do not use solvents (alcohol, benzene, trichlorethylene), corrosive, or abrasive cleaners.

Disinfecting:

• Parts that come into contact with the patient must be disinfected with a detergent (e.g., 2% ammonia solution).
• Avoid using solvents or corrosive disinfectants, as they can cause cracks in plastic covers.

Maintenance Schedule:

• Maintenance by a service technician should be performed regularly, at least once every 24 months.
• Operators should perform regular checks annually.
• The RiX-70 DC system does not contain user-repairable parts. It must only be opened and maintained by qualified personnel.

Electromagnetic Compatibility (EMC):

The RiX-70 DC complies with IEC 60601-1-2 for electromagnetic emissions and is suitable for use in environments meeting specified conditions. It is designed to minimize radio interference, but mitigation measures like re-orienting or relocating the equipment may be necessary in some cases. Using only manufacturer-supplied cables is crucial to maintain electromagnetic performance.

Disposing of Obsolete Equipment:

The product contains various materials, including metals, plastics, and electronic components. At the end of its useful life, it must not be disposed of as unsorted municipal waste. It should be collected separately and delivered to specialized operators for recycling or disposal of Waste Electrical and Electronic Equipment (WEEE) in compliance with existing laws.

Trident RiX-70 DC Specifications

General

Brand	Trident
Model	RiX-70 DC
Category	Dental equipment
Language	English