Labomed PRIMA ENT User Manual

Labomed PRIMA ENT User Manual

Operating surgical microscopy
Hide thumbs Also See for PRIMA ENT:

Advertisement

PRIMA ENT/DNT
Operating Surgical Microscopy
User Manual
To ensure proper use of this instrument as well as to avoid injury while operating instrument, understanding this manual
Completely before use is highly recommended.
6137000-795
Prima ENT/DNT
Issue 1.5
Printed on Feb.26,2019

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the PRIMA ENT and is the answer not in the manual?

Questions and answers

Subscribe to Our Youtube Channel

Summary of Contents for Labomed PRIMA ENT

  • Page 1 PRIMA ENT/DNT Operating Surgical Microscopy User Manual To ensure proper use of this instrument as well as to avoid injury while operating instrument, understanding this manual Completely before use is highly recommended. 6137000-795 Prima ENT/DNT Issue 1.5 Printed on Feb.26,2019...
  • Page 2 The information contained in this document was accurate at the time of publication. Specifications are subject to change without prior notice. LABOMED reserve 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.
  • Page 3: Table Of Contents

    Prima ENT/DNT TABLE OF CONTENTS Introduction and Intended use Product Description 2 - 3 Warning & Cautions 4 - 6 Explanation of Symbols Standard and Directives applicable Condition of instrument at the time of unpacking/supply 7A Installation of Base (Mobile Stand)
  • Page 4: Introduction And Intended Use

    6. Rigid H-form base with castor wheels provides greater stability as well as mobility to the instrument. INTENDED USE Prima ENT/DNT Surgical Microscope is an AC powered device intended for use during diagnosis and Surgery to provide a magnified view of surgical field. .
  • Page 5: Product Description

    Prima ENT/DNT PRODUCT DESCRIPTION Catalog no. 6138000-000 Model : Prima DNT Fig. 1 1. Wheel with Brakes 15. Magnification changer 2. H shape metal Base 16. Handle 3. Column 17. Common Main Objective 4. Swivel arm 18. Magnichanger inclination movement lock 5.
  • Page 6: Product Description

    Prima ENT/DNT PRODUCT DESCRIPTION Catalog no. 6137000-000 Model : Prima ENT LABOMED Part # ....LABO AMERICA, I 9 N 2C 0 , . Auburn Court Fremont CA 94538 IP X6 www.laboamerica.com Fig. 1.1 1. Wheel with Brakes 15. Magnification changer 2.
  • Page 7 WARNING: THIS INSTRUMENT SHOULD BE USED IN STRICT ACCORDANCE WITH THE INSTRUCTIONS OUTLINES IN THIS USER’S GUIDE. THE SAFETY OF THE OPERATOR AND THE PERFORMANCE OF THE INSTRUMENT CANNOT BE GUARANTEED IF USED IN A MANNER NOT SPECIFIED BY LABOMED. WARNING: DO NOT REPAIR OR SERVICE THIS INSTRUMENT WITHOUT AUTHORIZATION FROM THE MANUFACTURER.
  • Page 8: Warning & Cautions

    Prima ENT/DNT WARNING AND CAUTIONS 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.
  • Page 9 Prima ENT/DNT WARNING AND CAUTIONS A CAUTION is an instruction that draws attention to the risk of damage to the product. CAUTION: THE INTERNAL CIRCUITRY OF THE INSTRUMENT CONTAIN ELECTROSTATIC SENSITIVE DEVICES (ESD) THAT MAY BE SENSITIVE TO STATIC CHARGES PRODUCED BY THE HUMAN BODY.
  • Page 10: Explanation Of Symbols

    Prima ENT/DNT 4. EXPLANATION OF SYMBOLS Caution: Observe all warning labels and notes! If any label in missing on your instrument or has become illegible, please contact us or one of our Authorized representatives. We will supply the missing labels.
  • Page 11: Standard And Directives Applicable

    Prima ENT/DNT 5. 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 endo- scopes and endoscopic accessories Part 3: Determination of field of view and direction of view of endoscopes with optics.
  • Page 12: Condition Of Instrument At The Time Of Unpacking/Supply

    Prima ENT/DNT 6. CONDITION OF INSTRUMENT AT TIME OF UNPACKING/SUPPLY The appliance is delivered in sub-assembled modular groups along with one Installation Kit and one user manual. Please check for the following when unpacking the device: 1. Mobile supporting base with brakes on Castor wheels, or the type of mounting system.
  • Page 13: A Installation Of Base (Mobile Stand)

    Prima ENT/DNT 7A. 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 3. Lift up the Centre Support assembly as shown in fig.-3.
  • Page 14 Prima ENT/DNT INSTALLATION 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 8.
  • Page 15: Microscope Installation

    Prima ENT/DNT 7B. MICROSCOPE INSTALLATION 7.1 Open the Microscope Box. Remove pillar (Column) from the box. Engage this column onto the shaft matching the guide holes on column has shaft, as shown as B in Fig.-11. 7.1a Align the tapped holes of the column with the shaft and tighten three allen screws from the sides, as shown as C in Fig.-12.
  • Page 16 Prima ENT/DNT INSTALLATION Retrieve the inclined coupling assembly from the packing and follow as below refer Fig.-4. • Install the coupling to the suspension arm by sliding the guiding shaft (1) into the suspension arm. • Lock the inclined coupling with the threaded plug (3).
  • Page 17: Electrical Connection

    Replace the blown fuse with live fuse and secure back the fuse compartment. For fuse replacement refer label shown in fig.-9. AC Inlet 8.3 DATA PLATE FOR PRIMA ENT/DNT MICROSCOPE Fig. 9 UL Mark Safety Certification...
  • Page 18: Wiring Coding Diagram

    Prima ENT/DNT ELECTRICAL CONNECTIONS 8.4. PRIMA WIRING CODING DIAGRAM 6137000-795 Prima ENT/DNT Issue 1.5 Printed on Feb.26,2019...
  • Page 19: Control Elements

    Prima ENT/DNT 9. CONTROL ELEMENTS 9.1 ON/OFF SWITCH (SHOWN AS 1 IN FIG. 7 ABOVE) It is located on the back of the swivel arm. At ‘ON’ position, green LED glows and cooling fan starts running. Keep the intensity control knob at Minimum level before switching on the system.
  • Page 20: Instruction For Using The Microscope

    Prima ENT/DNT 10. INSTRUCTIONS FOR USING THE MICROSCOPE WARNING: INSTRUMENT IS UNSAFE FOR MRI ENVIRONMENT. SETTING UP OF MICROSCOPE: 1. Lock all the brakes on base wheels after setting up of microscope on the attendance area for stability. 2. Although tension on microscope is factory present as per the ordered configuration.
  • Page 21 Prima ENT/DNT MAIN MICROSCOPE The objective lenses with focal lengths of 250mm, 300mm and 400mm are available for different working distances. The ergonomic straight or 210 degree binocular tube is provided for the main surgeon. The large tilt range allows work with minimum fatigue.
  • Page 22: Changing The Objective & Eyepieces

    Prima ENT/DNT 11. CHANGING THE OBJECTIVES & EYEPIECES 1. The objectives can be taken out by rotat- ing i in anti-clock wise direction. It can be thread in by rotating in clockwise direction. 2. To install the eyepieces, insert in the eye tubes of observation head.
  • Page 23: Use Of Accessories

    Prima ENT/DNT 12. USE OF ACCESSORIES Part No.: 6138000-000 Model: Prima DNT EXTENDER ROTO PLATE ERGO HEAD CMO 250 CMO 350 CMO 400 CMO Nu-Var CCD CAMERA DSLR CAMERA Double Iris SONY HANDY CAM ADAPTER ASSISTOSCOPE ADAPTER ADAPTER FLOOR MOUNT Fig.
  • Page 24 Prima ENT/DNT USE OF ACCESSORIES Part No.: 6137000-000 Model: Prima ENT STRAIGHT BINOCULAR TUBE CMO 250 CMO 350 CMO 400 CCD CAMERA SONY HANDY CAM DSLR CAMERA DOUBLE IRIS ASSISTOSCOPE ADAPTER ADAPTER ADAPTER FOOT CONTROL Z AXIS FLOOR MOUNT Fig. 18 1.
  • Page 25: Thermal Cut-Off

    70°C. In case if thermal cut-off fails no risk will happen to the instrument only LED may get fuse. Here user needs to replace the LED only and thermal cut-off will start working again. To replace the LED user may call LABOMED service personal or authorized dealer. LED Specifications: 3.7 V, 13.5 Amp 14.
  • Page 26: Moving Position

    Prima ENT/DNT 15. MOVING POSITION OF THE SYSTEM Position of the system for safe transportation Fold the system as shown before moving RELOCATING THE STAND 1. Turn off the unit at the power switch. 2. Disconnect the power cable. 3. Remove the video cable from the video modules (e.g., video monitor, USB monitor) and the camera control unit.
  • Page 27: Care And Maintenance

    Prima ENT/DNT 16. CARE AND MAINTENANCE This instrument is a high grade technological product and not required any special periodical Maintenance if handed carefully. To ensure optimum performance and safe working order of the Instrument, its safe functioning must be checked once every 12 months as per table below. We Recommended having this check performance by our service representative as part of regular Maintenance work.
  • Page 28: Care And Maintenance

    • Do not clean products and optical components in a cleaning/disinfecting device or ultra sound bath. • LABOMED MaxiLite coatings are fungal resistant. If you clean as described above, the coatings will not be damaged. TROPICAL ENVIRONMENT/FUNGUS: LABOMED employs certain safety precaution in its manufacturing techniques an and materials. other preventive measures include: •...
  • Page 29: Ambient Requirement

    Prima ENT/DNT 17. AMBIENT REQUIREMENT +10˚C..+40˚C For Operation Temperature Rel. Humidity 30%..90% (without condensation) Air Pressure 700hPa..1,060hPa Temperature -40˚C..+70˚C For Transportation and 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 30: Disposals

    Prima ENT/DNT 18. DISPOSAL Disposal of the instrument must comply with locally applicable laws and regulations. Issue 1.5 6137000-795 Prima ENT/DNT Printed on Feb.26,2019...
  • Page 31 Prima ENT/DNT 19. TROUBLESHOOTING TABLE Problem Possible Cause Remedy No illumination Plug in power cable Power cable not plugged in Press the power switch to ON Power switch in OFF position position Change the fuse Defective instrument fuse Change the power cable...
  • Page 32: Troubleshooting Table

    Prima ENT/DNT TROUBLESHOOTING TABLE Problem Possible Cause Remedy The brakes on the wheels are not Engage the brakes Stand is unstable in use Magnichanger is not indexed Index magnichanger properly No image is visible in the properly field of view 6137000-795 Issue 1.5...
  • Page 33: Technical Specification

    Prima ENT/DNT 20. TECHNICAL SPECIFICATIONS Binocular Tubes Ergo viewing tube 0° - 210° (tiltable), IPD 50-75mm Optional: Straight viewing tube 90°, IPD 55-75mm Eyepieces WF 10x/18mm with retractable eye guards, diopter adjustment ± 5mm and diopter lock Optional: WF 12.5x/18mm; fixed eye guards.
  • Page 34: 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.
  • Page 35 All Equipment and Systems Guidance and Manufacturer’s Deceleration - Electromagnetic Emissions 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 Guidance and manufacturer’s Deceleration – 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. Immunity Test...
  • Page 37 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 communication equipment.
  • Page 38: Measures & Weight

    Prima ENT/DNT 22. MEASURES AND WEIGHT Prima ENT/DNT- Microscope with Mobile Stand Total Weight: Approx. 88 kgs. WALL MOUNT CEILING MOUNT 1124.6mm 525mm 1124.6mm 525mm FLOOR MOUNT 1464.6mm 843mm 525mm 536mm 6137000-795 Issue 1.5 Prima ENT/DNT Printed on Feb.26,2019...
  • Page 39: Glossary

    Prima ENT/DNT 23. GLOSSARY Compensation of short-or-far-sightedness. This can be done for each Ametropia Compensation eye using the two individual eyepieces (range: +5 to -5 diopters). Distance front lens to object level (250mm). Working Distance Refers to the color characteristic of a light source. Using color...
  • Page 40: Warranty

    LABOMED factory or authorized LABOMED Dealer. All claims under this warranty must be in writing and directed to the LABOMED factory or its authorized dealer for this device making the original sale and must be accompanied by a copy of the purchaser’s invoice.
  • Page 41 920 Auburn Court Fremont, CA 94538 U.S.A. Phone: 510-445-1257 Fax: 510-991-9862 Email: sales@laboamerica.com www.laboamerica.com EV REP. Labomed Europe b.v. T.a.v.: Cor Treure Essebaan 52, 2908 LK Capelle a an den Ijssel THE NETHERLANDS Phone: +31-10-458-4222, Fax: +31-10-450-8251 A16372 ISO 13485 LABOMED...

This manual is also suitable for:

Prima dnt

Table of Contents