Related Manuals for Bien Air BORA 2 LK
Summarization of Contents
1 Symbols
1.1 Description of Symbols
Explains the meaning of various symbols used in the manual.
2 Identification & Intended Use
2.1 Identification
Identifies the medical device manufacturer and its type.
2.2 Classification
States the device classification according to European directives.
2.3 Intended Use
Specifies the intended professional use and limitations of the device.
2.4 Intended Patient Population and Medical Conditions
Defines the eligible patient population and their medical conditions.
2.5 Intended User
Specifies that only dentists and dental professionals should use the device.
2.6 Intended Medical Condition
Details the medical conditions for which the device is intended.
2.7 Patient Contra-indications
States that there are no specific contra-indications when used as intended.
2.8 In Case of Accidents
Outlines procedures in case of accidents, including reporting and repair.
3 Warnings and Precautions for Use
3.1 General Information
Provides general guidelines for using the device safely and correctly.
3.2 Specific Warnings
Lists essential warnings regarding misuse, modification, and handling.
4 Description
4.1 Device Overview
Provides an overview of the device and its main parts with a diagram.
Electric Power Supply
Specifies requirements for the device's electric power supply systems.
TU Bora 2 LED Classification
Classifies the TU Bora 2 LED according to medical equipment standards.
4.2 Technical Data
Compatible Shanks
Lists compatible shanks according to ISO standards.
Spray Water Consumption Caution
Warns about the minimum spray water consumption requirement.
4.3 Performances
Bur Chuck Specifications (FIG. 2)
Details bur chuck specifications and compatibility.
4.4 Bur Chuck Warning
Bur Compliance Warning
Warns about using non-compliant burs and potential risks.
5 Operation
Operation Pictograms
Explains the meaning of pictograms used in the operation section.
5.1 Changing the Bur
Provides step-by-step instructions for changing the bur.
Bur Insertion Warning
Warns against partial bur insertion and overheating.
Spray Outlet Caution
Advises to ensure spray outlets are not obstructed.
5.2 Installing the Turbine
Turbine Disconnection (FIG. 4)
Illustrates the process of disconnecting the turbine.
6 Operating Conditions
TU Bora 2 LED Operating Parameters
Lists the operating temperature, humidity, and air pressure for TU Bora 2 LED.
TU Bora 2 LK Operating Conditions
States that no particular operating conditions are required for TU Bora 2 LK.
7 Cleaning and Servicing
7.1 Maintenance - General Information
Provides general information and precautions for instrument maintenance.
Non-Sterile Instrument Warning
States the instrument is non-sterile and requires cleaning before first use.
7.1.1 Precautions for Maintenance
Lists precautions to be taken during maintenance procedures.
Cleaning Process Caution
Advises on cleaning processes and avoiding specific methods.
7.1.2 Suitable Maintenance Products
Lists recommended products for cleaning and disinfection.
7.2 Cleaning Procedures
Cleaning Preparation
Details the initial preparation steps before cleaning the device.
Removing Dirt and Deposits
Explains how to clean the exterior and interior of the device.
7.3 Disinfection
7.3.1 Manual Cleaning/Disinfection
Provides detailed steps for manual cleaning and disinfection.
7.3.2 Automatic Disinfection (Optional)
Explains the process for automatic cleaning and disinfection.
Thermo-disinfection Cycle Specifications
Disinfection Cooling Warning
Warns against cooling devices by rinsing them after disinfection.
7.4 Lubrication
7.4.1 Verifying Cleanliness
Advises to visually inspect the device for cleanliness before lubrication.
7.4.2 Lubrication with Lubrimed
Details the steps for lubricating the device with Lubrimed.
7.4.3 Lubrication with Lubrifluid
Lubrication Process Illustrations (FIG. 7 & 8)
Illustrates lubrication processes with Lubrifluid and lubricant collection.
7.5 Sterilization
Sterilization Cleanliness Warning
Emphasizes the importance of cleanliness for effective sterilization.
Coupling Sterilization Caution
States that couplings cannot be sterilized.
7.5.1 Sterilization Procedure
Provides the recommended procedure for steam sterilization.
Sterilization Cycle Parameters
Dynamic Air Removal Cycles Caution
Advises on using dynamic air removal cycles for sterilization.
7.6 Packing and Storage
TU Bora 2 LED Storage Conditions
Lists storage conditions for the TU Bora 2 LED.
Refrigerated Device Warming Caution
Advises warming up refrigerated devices before use.
Sterilization Pouch Expiration Caution
Reminds to comply with the expiration date of sterilization pouches.
8 Transport & Disposal
8.1 Transport Conditions
Specifies transport conditions for the TU Bora 2 LED.
TU Bora 2 LK Transport Conditions
States no particular transport conditions are required for TU Bora 2 LK.
8.2 Disposal Procedures
Outlines procedures for proper disposal and recycling of the device.
9 General Information
9.1 Terms of Guarantee
Details the warranty period and conditions for the medical device.
Warranty Voiding Caution
Warns that damage from incorrect servicing voids the warranty.
9.2 References
9.2.1 Medical Devices Reference
Lists medical devices with their respective REF and Legend.
9.2.2 Optional Accessories Reference
Lists optional accessories with their REF and Legend.
10 EMC (Electromagnetic Compatibility)
Radio Interference Warning
Warns about potential interference from radio transmitting equipment.
Accessory Compatibility Caution
Advises on the use of specified accessories to avoid increased emissions.
Adjacent Equipment Use Caution
Recommends avoiding adjacent or stacked equipment use.
Emissions Test Compliance
RF Emissions Guidance
Provides guidance on the electromagnetic environment for RF emissions.
Immunity Test Levels
IEC 60601 Test Levels
Lists IEC 60601 test levels for various immunity tests.
Immunity Compliance Levels
Specifies compliance levels for immunity tests.
Immunity Environment Guidance
Provides guidance on the electromagnetic environment for immunity tests.
Immunity Test Levels (Continued)
Voltage Dips & Magnetic Field Test Levels
Lists IEC 60601 test levels for voltage dips and magnetic fields.
Voltage Dips & Magnetic Field Compliance
Specifies compliance levels for voltage dips and magnetic fields.
Mains Magnetic Field Environment Guidance
Provides guidance on the electromagnetic environment for mains frequency magnetic fields.
RF Field Immunity Tests
Conducted RF Disturbances Test
Details test levels for conducted disturbances induced by RF fields.
Radiated RF EM Fields Test
Details test levels for radiated RF EM fields.
RF Field Environment Guidance
Provides guidance on electromagnetic environment for RF fields.
Proximity RF Wireless Equipment Immunity
Proximity Field Test Levels (IEC 61000-4-3)
Lists immunity test levels for proximity fields from RF wireless equipment.
Proximity Field Separation Guidance
Provides guidance on separation distances for RF transmitters.
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