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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.
R
Part No: 6165000-795
Issue1.4
Printed on March: 2016
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Related Manuals for Labomed PRIMA GN
Summary of Contents for Labomed PRIMA GN
- Page 1 PRIMA GN User Manual Colposcope Caution: Part No: 6165000-795 U.S. Federal law restricts this device to sale by or on the order of a licensed Issue1.4 physician. Rx only Printed on March: 2016 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.
- Page 2 Prima GN Prima GN is a tradename of Labotech Microscopes India Pvt. Ltd. Labomed is a registered trademark of Labo America, Inc. All other trademarks are property of their respective owners. The information contained in this document was accurate at time of publication. Specifications subject to change without notice.
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Page 3: Table Of Contents
Prima GN LIST OF CONTENTS Introduction and Intended use Product Description Warning & Cautions Explanation of Symbols Standard and Directives applicable Condition of instrument at the time of unpacking/supply 8-10 Installation Instruction Installation 11-12 Electrical Connection Replacing the illumination source... - Page 4 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.
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Page 5: Product Description
11. Swivel arm cover 12. Binocular head with eyepieces 13. Magnichanger 14. Handle 15. Common Main Objective 16. Illumination Control Knob 17. Magnichanger tiltation control knob 18. Inlet for LABOMED camera Issue 1.4 Printed on March, 2016 6165000-795 PRIMA GN... -
Page 6: Warning & Cautions
WARNING & CAUTIONS Warnings & Cautions LABOMED is not responsible for the safety and reliability of this instrument when: - Assembly, disassembly, repair, or modification is made by unauthorized dealers or persons. - Instrument is not used in accordance with this User's Guide. - Page 7 Prima GN WARNING: THIS INSTRUMENT IS NOT SUITABLE FOR USE IN THE PRESENCE OF FLAMMABLE AN ESTHETIC MIXTURES, SUCH AS OXYGEN OR NITROUS OXIDE. WARNING: LED RADIATION DO NOT STARE DIRECTLY INTO BEAM WHEN COLPOSCOPE IS IN ON POSITION. WARNING: THE USE OF ACCESSORIES OR CABLES OTHER THAN THOSE SPECIFIED, WITH...
- Page 8 Prima GN CAUTION: AN INSTRUCTION THAT DRAWS ATTENTION TO THE RISK OF DAMAGE THE PRODUCT. CAUTION: THE INTERNAL CIRCUITRY OF THE INSTRUMENT CONTAINS ELECTROSTATIC DISCHARGE SENSITIVE DEVICES (ESDS) THAT MAY BE SENSITIVE TO STATIC CHARGES PRODUCED BY THE HUMAN BODY. DO NOT REMOVE THE COVERS WITHOUT TAKING PROPER ESDS PRECAUTIONS.
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Page 9: Explanation Of Symbols
Prima GN EXPLANATION OF SYMBOLS Caution: Observe all warning labels and notes! If any label is missing on your instrument or has become illegal, please contact us or one of our authorized representatives. We will supply the missing labels. Brightness control: After the illumination has been switched on, you can continuously adjust the brightness of the fiber illumination by turning the appropriate knob. - Page 10 Prima GN STANDARDS AND DIRECTIVES The instrument described in this 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.
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Page 11: Condition Of Instrument At The Time Of Unpacking/Supply
Prima GN CONDITION OF INSTRUMENT AT THE TIME OF UNPACKING/SUPPLY The appliance is delivered in sub-assembled groups along with one set of Installation Kit and one instruction / service manual. Please check following at the time of unpacking: 1. Mobile supporting base with brakes on castor wheels, or the type of mounting system 2. -
Page 12: Installation
Prima GN INSTALLATION 7.1 Open the microscope box. Remove (column) from the box. Engage this column onto the shaft by aligning 3 guide holes on column and shaft, shown as B in Fig 13. 7.1a Tighten three Allen screws from the sides, shown as C in Fig 14. - Page 13 Prima GN 7.4 Retrieve the carrier assembly from the packing and follow as below refer Fig. 4. Install the coupling to the suspension arm by sliding the guiding shaft (1) to the suspension arm. Lock the inclined coupling with the threaded plug ...
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Page 14: Electrical Connection
AC Inlet For fuse replacement refer label shown in fig. 9 Fig. 9 8.3 Data Plate for Prima GN Colposcope UL Mark Safety Certification Accompanying Document must be consulted Device Name... -
Page 15: 8.4 Prima Wiring Coding Diagram
Prima GN 8.4 Prima Wiring Coding Diagram Issue 1.4 Printed on March, 2016 6165000-795 PRIMA GN... -
Page 16: Control Elements
Prima GN 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 INSTRUCTIONS FOR USING THE COLPOSCOPE WARNING: INSTRUMENT IS UNSAFE FOR MRI ENVIRONMENTS Setting up of Colposcope: Lock all the brakes on base wheels after setting up of microscope on the attendance area for stability. Although tension on microscope is factory preset as per the ordered configuration. - Page 18 Prima GN Main colposcope The objective lenses with fine focusing knob and focal lengths of 300 mm 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 10 x (option: 12.5 x).
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Page 19: Changing The Objectives & Eyepieces
Prima GN 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 clock wise direction. 2. To install the eyepieces, insert in the eye tubes 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 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... -
Page 21: Moving Position
Prima GN MOVING POSITION OF THE SYSTEM Position of the system for safe transportation. Fold the system as shown before moving Fig. 21 Relocating the stand Turn off the unit at the power switch Disconnect the power cable from line power. -
Page 22: Care And Maintenance
Prima GN CARE & MAINTENANCE CARE & 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 instruments, its safe functioning must be checked once every 12months as per table below. We recommended having this check performance by our service representative as part of regular maintenance work. - Page 23 Do not use ethanol and spirit. Do not clean products and optical components in a cleaning/disinfecting device or ultra sound bath. LABOMED MaxLite coatings are fungal resistant. If you clean as described above, the coatings will not be damaged.
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Page 24: Ambient Requirement
Prima GN AMBIENT REQUIREMENT For operation Temperature +10°C..+40° C Rel.humidity 30%..90% (without condensation) Air pressure 700hPa..1,060hPa For transportation Temperature -40°C..+70°C and storage Rel. humidity 10%..100% (without condensation) Air pressure 500hPa..1,060hPa The unit meets the essential requirements stipulated in Annex I to the 93/42/EEC directive governing medical devices. -
Page 25: Disposals
Prima GN DISPOSAL Disposal must comply with locally applicable laws & regulations. Issue 1.4 Printed on March, 2016 6165000-795 PRIMA GN... -
Page 26: Troubleshooting Table
Prima GN TROUBLESHOOTING TABLE Problem Possible Cause Remedy No Illumination at all Power cable not plugged Plug in power cable. Power switch not pressed Press power switch Defective instruments fuse Change instrument fuse Defective power cable Change power cable Line power failure... - Page 27 Prima GN Problem Possible Cause Remedy Thermal cut-off in lamp Clean thermal cut-off with a housing is contaminated. dry brush; blow it clean, if necessary Illuminate surgical field using Defective fan. Failure of alternate illuminator and contact system electronics. service deartment Up &...
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Page 28: Technical Specification
Prima GN TECHNICAL SPECIFICATIONS Technical Data (Specifications) Binocular tubes Straight viewing tube 90°, IPD 50-75mm Optional: 45° inclined head, 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 29: Guidance Tables
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. Electromagnetic Environment... - Page 30 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Prima GN is intended for use in electromagnetic environment specified below. The customer or user of the Prima GN should ensure that it is used in such an environment. Immunity IEC 60601...
- 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. IEC 60601...
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Page 32: Guidance Tables
Recommended Separation Distances for between Portable and Mobile RF Communications Equipment and the Prima GN The Prima GN is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the Prima GN can help prevent... -
Page 33: Measures & Weight
Prima GN MEASURES & WEIGHT Prima GN- Colposcope with Mobile Stand Total Weight: Approx. 80 kgs. Fig. 22 Issue 1.4 Printed on March, 2016 6165000-795 PRIMA GN... -
Page 34: Glossary
Prima GN GLOSSARY Ametropia compensation Compensation of short- or far-sightedness. This can be done for each eye individually by means of the two eye-pieces (range: +5 to -5 diopters). Working distance Distance front lens to object level (= 300 mm). -
Page 35: 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 authorized instrument dealer making the original sale and must be accompanied by a copy of the purchaser's invoice. - Page 36 Our policy is one of continuous development. Labotech Microscopes India Pvt. Ltd. reserves the right to change design and specifications without prior notice. Manufactured for: U.S.A. Labo America Inc. Telephone: 510 445 1257 920 Auburn Court Fax: 510 991 9862 Fremont sales@laboamerica.com...