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Information regarding proprietary content, copyright, and modification restrictions.
Details on document revisions and company responsibility for specification discrepancies.
Explanation of how part numbers and revision numbers are indicated and updated.
Information on symbols used on the product, packaging, and in the user manual.
Guidelines for intended users, reading instructions, and equipment modification.
List of actions strictly forbidden during the use of the equipment.
Details critical safety warnings related to electrical hazards and system integrity.
Defines the purpose of the REMEX-KA6, target users, and compliance responsibilities.
Details the intended medical indication, patient population, and tissue application.
Technical specifications of the REMEX-KA6, including electrical and physical properties.
Lists relevant international and European safety standards for medical electrical equipment.
Details the front and rear views of the main body, including key components and LEDs.
Provides the physical dimensions and weights of the main unit and its accessories.
Specifies the environmental conditions required for the proper operation of the device.
Defines the environmental conditions for storing and transporting the equipment safely.
Description and location of various symbols used on the product and its packaging.
Details the labels found on the main body of the REMEX-KA6 and their locations.
Lists common operations and functions of the REMEX-KA6 for user reference.
Steps and considerations before operating the REMEX-KA6, including user qualifications.
Detailed steps for performing X-ray operations with the REMEX-KA6.
Instructions for safely storing and cleaning the REMEX-KA6 after use.
Methodology for measuring radiation quantity using a phantom and dosimeter.
Lists and describes potential error codes displayed by the REMEX-KA6.
Summary of electrical classifications, operating modes, and radiation quantities.
Details on tube voltage, current, exposure time, and conditions by mode.
Technical details of the X-ray tube, including voltage, current, focal spot, and filtration.
Specifications for the high voltage tank, including type, voltage, current, and filtration.
Information on the beam limiting device, including type, SSD, and radiation shielding.
Details on the rechargeable battery, including model, manufacturer, type, and capacity.
Specifications for the AC/DC adapter, including model, manufacturer, and input/output ratings.
Information about the built-in software, including name and version.
Mentions the availability of an optional wired remote control switch.
Specifies the requirements for digital X-ray image receptors to be used with the device.
Guidance on operator safety regarding residual radiation and zone of occupancy.
Parameters to be measured annually for maintaining imaging performance.
Describes the rising, falling, and ripple characteristics of the X-ray tube voltage.
Step-by-step instructions for replacing the rechargeable battery.
Recommendation for annual inspection by qualified personnel.
Guidelines for the proper disposal of the device according to country specifications.
Information on obtaining repair documentation like circuit diagrams and part lists.
Details on assessing radiation levels for operators, referencing the significant zone of occupancy.
Guidance and declaration on electromagnetic emissions according to CISPR 11 and IEC 61000 standards.
Guidance on electromagnetic immunity for ESD, surges, and voltage variations (IEC 60601).
Immunity guidelines for RF conducted and radiated emissions, and recommended separation distances.
Provides contact details for REMEDI Co., Ltd. for services, products, and inquiries.
General| Brand | REMEDI |
|---|---|
| Model | REMEX-KA6 |
| Category | Medical Equipment |
| Language | English |
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