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Defines WARNING, CAUTION, and NOTE symbols and their meanings.
Provides general safety guidelines for operating the camera head.
Lists known contraindications related to the medical device.
Specifies the required qualifications for operating personnel.
Details the camera head's suitability for 50 Hz or 60 Hz operation.
General guidance on operating the camera head.
Step-by-step instructions for connecting the endoscope and cable.
Instructions on how to adjust the camera's focus.
Lists technical data for the camera head.
Specifies environmental conditions for storage and operation.
Details compliance with relevant IEC standards.
Outlines compliance with the Medical Device Directive (MDD).
Guidelines for proper handling and care of the camera head.
Important warnings regarding reprocessing and infection risk.
Lists accessories required for reprocessing.
Procedure for manual wipe-down disinfection.
Steps for preparing the device for cleaning and disinfection.
Detailed instructions for manual cleaning.
Detailed instructions for manual disinfection.
Steps for assembling, inspecting, and caring for the device.
Guidelines on approved packaging materials for reprocessing.
Details sterilization methods approved by KARL STORZ.
Specific procedures for STERIS® V-PRO® sterilization.
Information on the product's service life and reprocessing limits.
Guidelines for proper handling and care of the camera head for US customers.
Important warnings for US customers regarding reprocessing.
Lists accessories required for reprocessing for US customers.
Instructions for pre-cleaning the device at the patient's bedside.
Detailed instructions for manual cleaning for US customers.
Steps for assembly, inspection, and care for US customers.
Guidelines on packaging systems for US customers.
Details sterilization methods for US customers.
Procedures for Ethylene Oxide sterilization.
Procedures for STERIS® System 1E® sterilization.
Procedures for high-level disinfection.
Information on the product's service life and reprocessing limits.
Information on preventive and regular maintenance.
Guidelines for servicing and repairing defective equipment.
Instructions for proper disposal of the unit according to WEEE directive.
Details on who is authorized to repair devices.
Precautions to prevent infections during handling.
Manufacturer's conditions for liability and warranty.
Information regarding the warranty period and conditions.
Details the device's compliance with EMC standards.
General| Category | Medical Equipment |
|---|---|
| Manufacturer | Karl Storz |
| Model | IMAGE1 S 4U Rubina |
| Resolution | 4K UHD |
| 3D | Yes |
| NIR/ICG | Yes |
| Fluorescence Imaging | Yes |
| Light Source | LED |
| Compatibility | KARL STORZ endoscopes |
| Display | External monitor required |
| Dimensions | Varies by configuration |
| Weight | Varies by configuration |
| Special Feature | Rubina technology for enhanced visualization |
| Ports | Multiple video output ports |
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