Labomed PRIMA GN User Manual
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Labomed PRIMA GN User Manual

Colposcope
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PRIMA GN
User Manual
COLPOSCOPE
Caution:
U.S. Federal Law restricts this device to sale by or on the order of a licensed Physician. Rx only
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.
Part No.: 6165000-795
Issue 1.9
Printed on May,2023

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  • Page 1 PRIMA GN User Manual COLPOSCOPE Caution: U.S. Federal Law restricts this device to sale by or on the order of a licensed Physician. Rx only Part No.: 6165000-795 To ensure proper use of this instrument as well as to avoid injury while operating instrument, Issue 1.9...
  • 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 GN LIST OF CONTENTS Introduction and Intended use Product Description Warning & Cautions 3 - 5 Explanation of Symbols Standard and Directives applicable Condition of instrument at time of unpacking/supply Installation Instructions Installation 9 - 10 Electrical Connection Replacing the illumination source...

  • 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 LABOMED Colposcope Prima Gn is a device designed to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. it is used to diagnose abnormalities and select areas for biopsy.

  • Page 5: Product Description

    16. Illumination Control Knob 5. Suspension arm 17. Magnichanger tiltation control knob 6. Swivel Arm Locking Knob 18. Inlet for LABOMED camera 7. Suspension arm movement locking knob 8. Coupling movement locking knob 9. Suspension arm hydraulic movement lock 10. Suspension arm spring tension adjustment 11.

  • Page 6: Warning & Cautions

    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 7 PRIMA GN WARNINGS AND CAUTIONS WARNING: LED RADIATION - DO NOT STARE DIRECTLY INTO THE BEAM WHEN THE MICROSCOPE IS IN THE ON POSITION. WARNING: THE USE OF ACCESSORIES OR CABLES OTHER THAN THOSE SPECIFIED, WITH THE EXCEPTION OF THOSE SOLD BY THE MANUFACTURER AS REPLACEMENT PARTS FOR THE INTERNAL COMPONENTS, MAY RESULT IN INCREASED EMISSIONS OR DECREASED IMMUNITY OF THE EQUIPMENT OR SYSTEM.
  • Page 8 PRIMA GN WARNINGS 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 9: Explanation Of Symbols

    PRIMA GN 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 10: Standard And Directives Applicable

    PRIMA GN 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 11: Condition Of Instrument At Time Of Unpacking/Supply

    PRIMA GN 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 12 PRIMA GN 7A. 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, shown as B in fig.-13. 7.1 a Tighten three allen screws from the sides, as shown as C in Fig.-14.

  • Page 13: Installation

    PRIMA GN INSTALLATION 7.4 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 (2).

  • Page 14: Electrical Connection

    On/off Switch 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 GN MICRO- SCOPE UL Mark Fig. 9 Safety Certification Accompanying Document...

  • Page 15: Prima Wiring Coding Diagram

    PRIMA GN ELECTRICAL CONNECTIONS 8.4. PRIMA WIRING CODING DIAGRAM 6165000-795 Prima GN Issue 1.9 Printed on May,2023...

  • Page 16: Control Elements

    PRIMA GN 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 17: Instruction For Using The Colposcope

    PRIMA GN 10. INSTRUCTIONS FOR USING THE COLPOSCOPE WARNING: INSTRUMENT IS UNSAFE FOR MRI ENVIRONMENT. SETTING UP OF COLPOSCOPE: 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 as per the ordered configuration.
  • Page 18 PRIMA GN MAIN COLPOSCOPE The objective lenses with fine focusing knob and focal lengths of 300mm is available for different working distances. The straight binocular tube is provided for the main surgery. The standard equipment includes eyepieces with a magnification factor of 10X (option: 12.5X)

  • Page 19: Changing The Objectives & Eyepieces

    PRIMA GN 11. CHANGING THE OBJECTIVES & EYEPIECES 1. The objectives can be taken out by rotating it in anti-clock wise direction. It can be threaded in by rotating in clockwise direction. To install the eyepieces, insert in the eye of observation head.

  • Page 20: 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, 18.5 Amp 14.

  • Page 21: Moving Position

    PRIMA GN 15. MOVING POSITION OF THE SYSTEM Position of the system for safe transportation Fold the system as shown before moving Fig. 21 RELOCATING THE STAND 1. Turn off the unit at the power switch. 2. Disconnect the power cable.
  • Page 22 PRIMA GN 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 23: Care And Maintenance

    Do not use ethanol and spirit. • 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.

  • Page 24: Ambient Requirement

    PRIMA GN 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 25: Disposals

    PRIMA GN 18. DISPOSAL Disposal of the instrument must comply with locally applicable laws and regulations. 6165000-795 Prima GN Issue 1.9 Printed on May,2023...
  • Page 26 PRIMA GN 19. TROUBLESHOOTING TABLE Problem Possible Cause Remedy Plug in power cable No illumination Power cable not plugged in Press the power switch to ON Power switch in OFF position position Defective instrument fuse Change the fuse Change the power cable...

  • Page 27: Troubleshooting Table

    PRIMA GN 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 No image is visible in the Index magnichanger properly field of view properly...

  • Page 28: Technical Specification

    PRIMA GN 20. TECHNICAL SPECIFICATIONS Straight viewing tube 90°, 49-78mm Binocular Tubes Optional: 45° inclined head, IPD 55-75mm WF 10x/18mm with retractable eye guards, Eyepieces diopter adjustment ± 7mm and diopter lock Optional: WF 12.5x/18mm; fixed eye guards. 5 step: 0.4x, 0.6X, 1.0X, 1.6X & 2.5x;...

  • Page 29: Guidance Tables

    All Equipment and Systems Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The Prima GN is intended for use in the electromagnetic environment specified below. The customer or user of the Prima GN should ensure that it is used in such an environment.
  • Page 30 All Equipment and Systems Guidance and Manufacturer’s Declaration - Electromagnetic Emissions Prima GN is intended for use in the electromagnetic environment specified below. The customer or user of the Prima GN should ensure that it is used in such an environment.
  • Page 31 Guidance and manufacturer’s Declaration – Electromagnetic Immunity The Prima GN is intended for use in the electromagnetic environment specified below. The customer or user of the Prima GN should ensure that it is used in such an environment. Immunity Test...
  • Page 32 The Prima GN is intended for use in electromagnetic environments in which radiated RF disturbances are controlled. The customer or user of the Prima GN can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Prima GN as recommended below, according to the maximum output power of the Communication equipment.

  • Page 33: Measures & Weight

    PRIMA GN 22. MEASURES AND WEIGHT Prima GN- Colposcope with Mobile Stand Total Weight: Approx. 80 kgs. FLOOR MOUNT Fig. 22 6165000-795 Prima GN Issue 1.9 Printed on May,2023...

  • Page 34: Glossary

    PRIMA GN 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 (300mm). Working Distance Refers to the color characteristic of a light source. Using color...

  • Page 35: Warranty

    Lamps, bulbs, 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 authorized instrument dealer making the original sale ands must be accompanied by a copy of the purchaser’s invoice.
  • Page 36 By signing below, purchaser confirms that the correct and secure installation of mounting plates and hardware for the LABOMED Prima microscope(s) purchased is the sole responsibility of the purchaser and appointed contractor, and will comply with applicable building codes and good practices.
  • Page 37 Oct 10,2018 Information on S Bal DCR/19A/18 weight Formatting April 20,2019 DCR/12/19 S Bal apperance of text Reviewed April 14,2022 DCR/11/22 S Bal Accessories May 13, 2023 DCR/09/23 S Bal Page Updated 6165000-795 Prima GN Issue 1.9 Printed on May,2023...
  • Page 38 920 Auburn Court Fremont, CA 94538 U.S.A. Phone: 510-445-1257 Fax: 510-991-9862 Email: sales@laboamerica.com www.laboamerica.com EU REP. Labomed Europe Essebaan 50 NL-2908 LK Capelle a/d IJssel The Netherlands Tel: +31 (0)10 4584222 Fax: +31 (0)10 4508251 E-mail: info@labomedeurope.com A16372 ISO 13485:2016...

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