R
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
Issue1.4
Printed on March: 2016
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. Labotech Microscopes India Pvt. Ltd. reserves the right to make changes in
the product described in this manual without notice and without incorporating those changes in any
products already sold.
ISO 9001/13485 Certified – Labomed products are designed and manufactured under quality
processes meeting ISO 9001/13485 requirements.
No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or
by any means, electronic, mechanical, recording, or otherwise, without the prior written permission of
Labotech Microscopes India Pvt. Ltd.
Caution: Federal law restricts this device to sale by or on the order of a licensed physician. Rx
only.
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6165000-795 PRIMA GN
Issue 1.4
Printed on March, 2016
LIST OF CONTENTS
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7
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1. Introduction and Intended use
2. Product Description
Prima GN
3. Warning & Cautions
4. Explanation of Symbols
5. Standard and Directives applicable
6. Condition of instrument at the time of unpacking/supply
7. Installation Instruction
Installation
8. Electrical Connection
Replacing the illumination source
Fuse Replacement
Data Plate Details
Prima Wiring Coding Diagram
9. Control Elements
10. Instruction for using the colposcope
11. Changing the Objectives & Eyepieces
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8-10
11-12
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14
15
16-17
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12. Use of Accessories
13. Thermal Cut-off
14. Tension Adjustment while using accessories
15. Moving Position
16. Care and Maintenance
17. Ambient Requirement
18. Disposals
19. Troubleshooting Table
20. Technical Specification
21. Guidance Tables
22. Measures & weight
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19
19
20
21 - 22
23
24
25-26
27
28-31
32
23. Glossary
24. Warranty
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Prima GN
INTRODUCTION
The LABOMED Prima GN is a surgical and diagnostic instrument used for colposcopy in Gynecology,
which is adaptable for different surgical needs without compromise to performance.
Salient features of this Colposcope are:
1. The observation head can easily be positioned with the help of suspension arm .
2. An advanced 5-step magnification changer allows an optimal magnification for a particular
surgery from five different magnifications.
3. Cold light illumination with a high intensity 50W LED lamp is provided using a fiber optic guide
for proper illumination. The illumination is further adjustable up to its most suitable brightness
using intensity control knob suitably located at the suspension arm, and is easily approachable
to the surgeon.
4. When the colposcope is not in use, the suspension arm can be folded over the main body to
store it compactly.
5. Dual Iris Diaphgram allows greater depth of field particularly valuable for photography.
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.
NOTE: The use of Prima GN Colposcope is purely for intended Operative and Diagnostic medical use.
Configuration:
Colposcope Catalogue no.
Prima GN 6165000-000
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PRODUCT DESCRIPTION
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Fig. 1
1. Wheel with brake 2. Metal base with plastic cover
3. Column 4. Swivel arm
5. Suspension arm 6. Swivel arm locking knob
7. Suspension arm movement locking knob 8. Coupling movement locking knob
9. Suspension arm hydraulic movement lock 10. Suspension arm spring tension
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
6165000-795 PRIMA GN
adjustment
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Prima GN
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.
WARNING: AN INSTRUCTION THAT DRAWS ATTENTION TO RISK OF INJURY OR DEATH.
WARNING: USERS OF THIS EQUIPMENT SHOULD BE THOROUGHLY TRAINED IN THE
APPROPRIATE MEDICAL PROCEDURES. FURTHERMORE, THEY SHOULD TAKE THE TIME TO
READ AND UNDERSTAND THESE INSTRUCTIONS BEFORE PERFORMING ANY PROCEDURE.
THEY SHOULD ALSO READ AND UNDERSTAND THE INSTRUCTIONS FOR ANY OTHER
EQUIPMENT USED IN CONJUNCTION WITH THIS COLPOSCOPE (i.e. ELECTOSURGICAL
GENERATORS). FAILURE TO DO SO MAY RESULT IN INJURY TO THE PATIENT AND/OR
DAMAGE TO COLPOSCOPE.
WARNING: UNITED STATES FEDERAL LAW AND EUROPEAN REGULATIONS REQUIRE THAT
THIS DEVICE BE PURCHASED ONLY BY A PHYSICIAN OR A PERSON ACTING ON BEHALF OF
A PHYSICIAN.
WARNING: THIS INSTRUMENT SHOULD BE USED IN STRICT ACCORDANCE WITH THE
INSTRUCTIONS OUT LINED 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. ANY REPAIR OR SERVICE TO THIS INSTRUMENT MUST BE
PERFORMED BY EXPERIENCED PERSONNEL OR DEALERS WHO ARE TRAINED BY LABOMED
OR SERIOUS 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.
WARNING: TO AVOID RISK OF ELECTRIC SHOCK, THIS EQUIPMENT MUST ONLY BE
CONNECTED TO A SUPPLY MAIN WITH PROTECTIVE EARTH OR DAMAGE TO THIS
INSTRUMENT AND/OR INJURY TO THE OPERATOR OR PATIENT MAY OCCUR.
WARNING: ENSURE THAT THE VOLTAGE APPLIED TO THE UNIT IS THE SAME AS THE
VOLTAGE IS INDICATED ON THE DATA PLATE OR DAMAGE TO THE UNIT MAY OCCUR.
WARNING: THIS INSTRUMENT MUST BE PLUGGED IN TO AN OUTLET WITH AN EARTH
GROUND. DO NOT REMOVE OR DEFEAT THE EARTH GROUND CONNECTION ON POWER INPUT
CONNECTOR OR THE UNIT'S POWER CORD OF THIS INSTRUMENT OR DAMAGE TO IT AND/OR
INJURY TO THE OPERATOR OR PATIENT MAY OCCUR.
WARNING: THE EQUIPMENT OR SYSTEM SHOULD NOT BE USED ADJACENT OR STACKED
WITH OTHER EQUIPMENT LIKE MRI, RFID, SECURITY SYSTEM LIKE METAL DETECTORS OR
SIMILAR DEVICES. IF ADJACENT OR STACKED USE IS NECESSARY, THE EQUIPMENT OR
SYSTEM SHOULD BE OBSERVED TO VERIFY NORMAL OPERATION IN THE CONFIGURATION IN
WHICH IT WILL BE USED.
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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
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.
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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.
CAUTION: DO NOT USE SOLVENTS OR STRONG CLEANING SOLUTIONS ON ANY PART OF
THIS INSTRUMENT AS DAMAGE TO THE UNIT MAY OCCUR. SEE CARE & MAINTENANCE
SECTION FOR DETAILED CLEANING INSTRUCTION.
CAUTION: MEDICAL ELECTRONIC EQUIPMENT NEEDS SPECIAL PRECAUTIONS
REGARDING EMC AND NEEDS TO BE INSTALLED AND PUT IN TO SERVICE ACCORDING
TO THE EMC INFORMATION PROVIDED IN THE ACCOMPANYING DOCUMENTS.
CAUTION: PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT CAN AFFECT
MEDICAL ELECTRICAL EQUIPMENT.
CAUTION: THIS INSTRUMENT IS NOT TO BE USED NEAR HIGH-FREQUENCY EMITTING
SURGICAL EQUIPMENT.
CAUTION: DO NOT CONNECT ANY UNITS TO THE DEVICE OTHER THAN THE
INTENDED.
CAUTION: DO NOT USE A CONVERTER ADAPTER THAT WILL CONVERT THE THREE-
PRONG AC PLUG TO A TWO-PRONG LINE PLUG. THE POWER SUPPLY IN THIS
COLPOSCOPE WILL NOT BE PROPERLY GROUNDED THE ELECTRIC SHOK MIGHT RESULT.
CAUTION: REMOVE THE AC POWER PLUG FROM THE WALL SOCKET WHILE CHECKING
FOR BLOWN FUSE.
CAUTION: DO NOT ROLL THE COLPOSCOPE OVER CABLES OR HOSES ON THE FLOOR.
CAUTION: DO NOT REMOVE FERRITE BEADS IF APPLIED TO CABLES.
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PRIMA GN
Issue 1.
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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.
Accompanying documents must be consulted
Compliance to medical device directive 93/42/EEC
Protective earth
This way up- indicates correct upright position of the transport package.
RX
Only
Keep dry- transport package shall be kept away from rain.
Year of manufacture used on PRODUCT DATA
Fragile- contents of the transport package are fragile and therefore shall be handled
with care
U.S. Federal law restricts this device to sale by or on the order of a physician.
Electromagnetic interference can occur in the vicinity of devices carrying this symbol.
Alternating Current
Permissible humidity range during transport and storage
Permissible pressure range during transport and storage
Recycling of packaging materials
6165000-795
The product complies with US and Canadian safety requirements
Permissible temperature range during transport and storage
Separate disposal of waste electrical equipment
MR (Magnetic Resonance) unsafe symbol.
PRIMA GN
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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.
ISO 8600-3 First edition 1997-07-01 Optics and Optical instruments-Medical endoscopes
and endoscopic accessories Part 3: Determination of field of view and direction of view of
endoscopes with optics.
ISO 8600-5 First edition 2005-03-15 Optics and photonics-Medical endoscopes and
endotherapy devices- Part 5: Determination of optical resolution of rigid endoscopes with
optics.
ISO 9001/13485 quality management systems approved by UL (notified body).
ISO 14971-2007 Risk management to medical devices.
Directives used
Directives 93/42/EEC, Annex II, Article 3.
IEC 60601-1-3 edition (2005).
IEC 60601-1-2
EN 55011:2007
Classification
For Europe, per Directive 93/42/EEC, the unit is a Class I instrument
For USA: FDA classification Class II
Please observe all applicable accidental prevention regulations.
rd
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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. Column, depending on the type of mount ordered
3. Swivel arm and Suspension arm assembly with fibre optic cable.
4. Cover for swivel arm (pre-fitted to the microscope)
5. Inclined coupling with magni-changer assembly and objective (as ordered)
6. Observation Head, (inclined or ergo) as ordered
7. Paired Eye Pieces, as ordered
8. Power Cord
9. Installation Kit
a) Allen Wrench 5.00mm
b) Allen Wrench 8.00mm
10. Instruction cum Operating Manual / Service Manual
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