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Summary of Contents for Labomed PRIMA ENT
- Page 1 PRIMA ENT/DNT User Manual Operating Surgical Microscopy To ensure proper use of this instrument and to avoid injury during operation, reading this manual before use is highly recommended. 6137000-795 PRIMA ENT/DNT Issue 1.4 Printed March, 2016...
- Page 2 The information contained in this document was accurate at the time of publication. Specifications are subject to change without notice. LABOMED reserves the right to make changes to the product described in this user manual without notice and without incorporating those changes in any products already sold.
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Page 3: Table Of Contents
Prima ENT/DNT List Of Contents Introduction and Intended Use Product Description Warnings and Cautions Explanation of Symbols Standards and Directives Unpacking Installation Instructions - 7A Installation of Base (Mobile Stand) 12-13 - 7B Microscope Installation 14-15 Electrical Connections - Replacing the Illumination Source... -
Page 4: Introduction And Intended Use
Intended Use The Prima ENT/DNT microscope is an AC powered device intended for use during diagnosis and surgery to provide a magnified view of the region of interest. NOTE: Use Prima ENT/DNT microscopes as specified in the intended use. -
Page 5: Product Description
Prima ENT/DNT PRODUCT DESCRIPTION Prima DNT Wheel with brake Ergo Head 0-210° adjustable H shape metal base Magnification changer (magnichanger) Column Handles Swivel arm Common main objective (CMO) Suspension arm Magnichanger inclination Swivel arm locking knob movement lock Suspension arm movement locking knob... - Page 6 Prima ENT/DNT Prima ENT Wheel with brake Binocular head H shape base Magnification changer Column Handles Swivel arm Common main objective (CMO) Suspension arm Magnichanger inclination movement lock Swivel arm locking knob Illumination control knob Suspension arm movement locking knob...
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Page 7: Warnings And Cautions
INJURY TO THE OPERATOR OR PATIENT MAY OCCUR. WARNING: MODIFICATIONS TO THIS INSTRUMENT ARE NOT ALLOWED. ANY MODIFICATION TO THIS UNIT MUST BE AUTHORIZED BY LABOMED, OR SERIOUS INJURY TO THE OPERATOR OR PATIENT MAY OCCUR. WARNING: IF THIS INSTRUMENT IS MODIFIED, APPROPRIATE INSPECTION AND TESTING MUST BE CONDUCTED TO ENSURE CONTINUED SAFE USE OF THIS INSTRUMENT. - Page 8 Prima ENT/DNT WARNING: THIS INSTRUMENT IS NOT SUITABLE FOR USE IN THE PRESENCE OF FLAMMABLE ANESTHETIC MIXTURES SUCH AS OXYGEN OR NITROUS OXIDE. WARNING: LED RADIATION - DO NOT STARE DIRECTLY INTO THE BEAM WHEN THE MICROSCOPE IS IN THE ON POSITION.
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Page 9: Explanation Of Symbols
Prima ENT/DNT EXPLANATION OF SYMBOLS Caution: Observe all warning labels and notes! If any label is missing on your instrument or has become illegible, please contact the manufacturer to obtain new labels. Brightness control: After the illumination has been switched on, the user can continuously adjust brightness by turning the appropriate knob. -
Page 10: Standards And Directives
Prima ENT/DNT STANDARDS AND DIRECTIVES The instrument described in this user manual has been designed in compliance with the following standards: · ISO 8600-3 First edition 1997-07-01 AMENDMENT 1 Optics and Optical instruments- Medical endoscopes and endoscopic accessories Part 3: Determination of field of view and direction of view of endoscopes with optics. -
Page 11: Unpacking
Prima ENT/DNT UNPACKING The appliance is delivered in sub-assembled groups along with one Installation Kit and one user manual. Please check for the following when unpacking the device: Mobile supporting base with brakes on caster wheels or other type of mounting... -
Page 12: Installation Of Base (Mobile Stand)
Prima ENT/DNT INSTALLATION OF BASE (MOBILE STAND) Open the Center Support assembly box as shown in Fig. 1. Fig 1 Remove the tool kit and foam sheets as shown in Fig. 2. Fig 2 Lift up the Center Support assembly as shown in Fig. - Page 13 Prima ENT/DNT Lift the Wheel Support assembly and cover as shown in Fig. 7. Place it (wheels down) under one end of the Center Support as shown in Fig 8. Repeat procedure for the other Wheel Support assembly. Fig 7...
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Page 14: Microscope Installation
Prima ENT/DNT MICROSCOPE INSTALLATION Open the microscope box. Remove pillar (column) from the box. Engage this column to the base through indexing pin, shown as B in Fig 2. Align the tapped holes of the column with the base and tighten two allen screws from the bottom, shown as A in Fig 2. - Page 15 Prima ENT/DNT Remove the inclined coupling assembly from its packaging and follow the instructions below (see Fig. 4.) A. Install the coupling by sliding the shaft (1) Safety Screw into the suspension arm. B. Lock the inclined coupling with the threaded knob (3).
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Page 16: Electrical Connections
Prima ENT/DNT ELECTRICAL CONNECTIONS Connect the power cable to the AC inlet socket (1) located at the back of the swivel arm (see Fig. 7). Switch on the power using the on/off switch (2). Note: The power supply is designed with universal input 100V-240V AC, 50/60Hz. -
Page 17: Prima Wiring Coding Diagram
Prima ENT/DNT PRIMA WIRING CODING DIAGRAM... -
Page 18: Control Elements
Prima ENT/DNT CONTROL ELEMENTS ON/OFF Switch (see 2 in Fig. 7) The ON/OFF switch is located at the back of the swivel arm. In the ON position, a green LED glows, and the cooling fan starts running. Set the intensity control knob at the minimum intensity level before switching the system on. -
Page 19: Using The Microscope
Prima ENT/DNT USING THE MICROSCOPE WARNING: INSTRUMENT IS UNSAFE FOR MRI ENVIRONMENTS. Setting Up the Microscope For stability, lock both brakes on the caster wheels. IPD Knob Tension in the up and down motion of the microscope is preset at the factory. However, the... - Page 20 Objective lenses with focal lengths of 250 mm, 300 mm, 400 mm, or variable working distance are avail- able, depending on the user’s desired working distance. A straight binocular head (Prima ENT) or ergo/tilting binocular head (Prima DNT) is provided. Standard configurations include eyepieces with a magnification factor of 10x (12.5x eyepieces are...
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Page 21: Changing The Objectives And Eyepieces
Prima ENT/DNT CHANGING THE OBJECTIVES AND EYEPIECES The Common Main Objective (CMO) can be removed by rotating it in a counterclockwise direction. It can be attached by rotating it in a clockwise direction. To install the eyepieces, insert them in the eye tubes of the binocular head. -
Page 22: Use Of Accessories
Prima ENT/DNT USE OF ACCESSORIES Part No.: 6138000-000 Model: Prima DNT EXTENDER ROTO PLATE TILTING BINOCULAR HEAD DBSi CMO 400 CMO 250 CMO 350 CMO NuVar CCD CAMERA ASSISTOSCOPE DOUBLE IRIS SONY HANDYCAM DSLR CAMERA ADAPTER ADAPTER ADAPTER Floor Mount Fig 17 °... - Page 23 Prima ENT/DNT Part No.: 6137000-000 Model: Prima ENT STRAIGHT BINOCULAR TUBE CMO 250 CMO 350 CMO 400 CCD CAMERA SONY HANDYCAM DSLR CAMERA DOUBLE IRIS ADAPTER ASSISTOSCOPE ADAPTER ADAPTER FOOT CONTROL Z AXIS FLOOR MOUNT Fig 18 1. The following accessories are provided...
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Page 24: Thermal Cut-Off
Prima ENT/DNT THERMAL CUT-OFF The instrument is designed with safety provisions. Fans in the electrical box provide free- and forced-air circulation to cool the electronic components. The instrument also includes a built-in safety mechanism called “auto thermal cut-off.” This mechanism is activated when the LED temperature rises above 70°C, at which time power to the LED will be cut off. -
Page 25: Moving The Instrument
Prima ENT/DNT MOVING THE INSTRUMENT Fold the system as shown before moving Moving the Stand Turn off the unit at the power switch. Disconnect the power cable. Remove the video cable from the video modules (e.g., video monitor, USB monitor) and the camera control unit. -
Page 26: Care And Maintenance
CARE AND MAINTENANCE To ensure optimal performance of your instrument, we recommend annual preventative maintenance by an authorized LABOMED dealer. If a failure occurs which cannot be corrected using the troubleshooting table, attach a sign to the instrument stating that it is “out of order”... - Page 27 · Use 99% isopropyl alcohol to clean the optical components. · Dry the optical components using a microfiber cloth; dry the rest of the product using a paper towel. · Contact LABOMED or authorized service personnel for any service needs.
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Page 28: Ambient Requirements
Prima ENT/DNT AMBIENT REQUIREMENTS For operation Temperature +10°C..+40° C Rel. humidity 30%..90% (without condensation) Air pressure 700hPa..1,060hPa For transportation and Temperature -40°C..+70°C storage Rel. humidity 10%..100% (without condensation) Air pressure 500hPa..1,060hPa The unit meets the essential requirements stipulated in Annex I of the 93/42/EEC directive governing medical devices. -
Page 29: Disposal
Prima ENT/DNT DISPOSAL Disposal of the instrument must comply with locally applicable laws and regulations. -
Page 30: Troubleshooting Table
Prima ENT/DNT TROUBLESHOOTING TABLE Problem Possible Cause Remedy No illumination Power cable not plugged in Plug in power cable Power switch in OFF position Press the power switch to ON position Defective instrument fuse Change the fuse Defective power cable... - Page 31 Prima ENT/DNT Problem Possible Cause Remedy Insufficient illumination The thermal cut-off in the Clean the thermal cut-off (continued) lamp housing is contaminated with a dry brush or blow it clean, with compressed air Defective fan; failure of Contact the service...
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Page 32: Technical Specifications
Prima ENT/DNT TECHNICAL SPECIFICATIONS Binocular tubes Prima DNT: Tilting viewing tube (0°-210°) Prima ENT: Straight viewing tube (90°) Eyepieces WF 10x/18 mm with eye guards, diopter adjustment +/- 5mm and diopter lock Optional: WF 12.5x/18 mm Magnichanger 5 step: 0.4x, 0.6x, 1.0x, 1.6x and 2.5x... -
Page 33: Guidance Tables
All Equipment and systems Guidance and Manufacturer’s Declaration -Electromagnetic Emissions The Prima ENT/DNT is intended for use in the electromagnetic environment specified below. The customer or user of the Prima ENT/DNT should ensure that it is used in such an environment. Emissions Test... - Page 34 All Equipment and systems Guidance and Manufacturer’s Declaration -Electromagnetic Emissions The Prima ENT/DNT is intended for use in the electromagnetic environment specified below. The customer or user of the Prima ENT/DNT should ensure that it is used in such an environment. Immunity test...
- Page 35 Equipment and Systems that are NOT Life-supporting Guidance and manufacturer’s Declaration - Electromagnetic Immunity The Prima ENT/DNT is intended for use in the Electromagnetic environment specified below. The customer or user of the Prima ENT/DNT should ensure that it is used in such an environment.
- Page 36 Portable and Mobile RF Communications Equipment and the Prima ENT/DNT The Prima ENT/DNT is intended for use in electromagnetic environments in which radiated RF disturbances are controlled. The customer or user of the Prima ENT/DNT can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment (transmitters) and the Prima ENT/DNT as recommended below, according to the maximum output power of the communications equipment.
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Page 37: Dimensions And Weight
Prima ENT/DNT DIMENSIONS AND WEIGHT Wall Mount Ceiling Mount Floor Mount Prima ENT/DNT- Microscope with Mobile Stand Total Weight: Approx. 98 kgs. -
Page 38: Glossary
Prima ENT/DNT GLOSSARY Ametropia Compensation of short- or far-sightedness. This can be done for each eye Compensation using the two individual eyepieces (range: +5 to -5 diopters). Working Distance Distance from the common main objective (CMO) to the object or area of interest. -
Page 39: Warranty
Charts, cards, and other expendable items are not covered by this warranty. All claims under this warranty must be in writing and directed to the LABOMED factory or the authorized instrument dealer making the original sale and must be accompanied by a copy of the purchaser’s invoice. - Page 40 Fremont, CA 94538 sales@laboamerica.com U.S.A. LABOMED and Prima ENT/DNT are registered trademarks of Labo America, Inc. With a policy of continuous development, Labo America, Inc. reserves the right to change design and specifications without prior notice. © 2015 Labo America, Inc.
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