Labomed PRIMA GN User Manual Download Page 1

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o ensure proper use of this instrument as well as to avoid injury while

operating instrument, understanding this manual completely before use is
highly recommended.

User Manual

PRIMA GN

Colposcope

Part No: 6165000-795

Issue1.

Printed on

March:

201

U.S. Federal law restricts this device to sale by or on the order of a licensed
physician. Rx only

Caution:

Summary of Contents for PRIMA GN

Page 1: ...rating instrument understanding this manual completely before use is highly recommended User Manual PRIMA GN Colposcope R Part No 6165000 795 Issue1 4 Printed on March 2016 U S Federal law restricts this device to sale by or on the order of a licensed physician Rx only Caution ...

Page 2: ...ght 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 electr...

Page 3: ...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 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...

Page 4: ...nob 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 us...

Page 5: ... knob 9 Suspension arm hydraulic movement lock 10 Suspension arm spring tension adjustment 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 Fig 1 Prima GN 11 4 5 6 8 9 17 15 13 12 14 18 16 7 2 1 3 10 2 6165000 795 PRIMA GN Issue 1 4 Printed onMarch ...

Page 6: ...AIR 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 INSPECT...

Page 7: ...T 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 4 6165000 795 PRIMA GN Issue 1 4 Printed onMarch 2016 ...

Page 8: ... 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 CON...

Page 9: ...hall 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 RX Only 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 transpo...

Page 10: ...ew 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...

Page 11: ...ounting 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...

Page 12: ...he top Put protective cap 3 in place and loosen suspension arm locking B knobs so that it can be rotated 1 A 2 3 B 11 6165000 795 PRIMA GN Issue 1 4 Printed onMarch 2016 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 7 2 Ma...

Page 13: ...suspension arm Insert the light guide into the receptacle in the microscope till it clicks into position as shown as A in Fig 5 Make sure that the light guide has been routed in such a way that the carrier system and the surgical microscope are not obstructed and that they can be moved in their entire range of movement without stretching extreme kinking or twisting of the light guide 7 5 Install t...

Page 14: ...n off switch Use a flat head screw driver to open the fuse compartment Two fuses are provided in this i e one is live fuse and second as spare fuse Replace the blown fuse with live fuse and secure back the fuse compartment For fuse replacement refer label shown in fig 9 Fig 9 AC Inlet On off Switch 8 1 Replacing the illumination source 8 2 Fuse Replacement Device Name Model Number Serial Number In...

Page 15: ...Prima GN 8 4 Prima Wiring Coding Diagram 6165000 795 PRIMA GN Issue 1 4 Printed onMarch 2016 ...

Page 16: ...in front of the suspension arm shown as A in Fig 10 Brightness of field of view can be adjusted as per user comfort using intensity control knob 9 3 Swivel arm locking knob This knob helps you to lock the movement of swivel arm at the desired position after initial focusing of the attendance area by turning it clockwise knob is shown as B in Fig 10 9 4 Brakes Locks the stand from unwanted movement...

Page 17: ...onvenience 5 The illumination is controlled through the control knob A fig 12 Rotate it clockwise or anti clock wise to achieve desired illumination level Functional setup keep it as minimum Setting up of magnification Ref Fig 13 1 Adjust to highest magnification with one of the rotating knobs 11a provided at magnification changer 2 Fine focusing is done by knob provided on CMO shown as 11d in fig...

Page 18: ...s of 300 mm is available for different working distances Prima GN Fig 14 The straight binocular tube is provided for the main surgery The standard equipment includes eyepieces with a magnification factorof 10 x option 12 5 x 17 6165000 795 PRIMA GN Issue 1 4 Printed onMarch 2016 ...

Page 19: ...OF ACCESSORIES As shown to use accessories 1 Install double beam splitter by replacing the binocular tube straight or 45 degree inclined 2 Total four accessories are provided as follows 2 1 DSLR camera adapter for Nikon Canon and Sony 2 2 CCD camera adapter for Mintron 2 3 Adapter for Sony Handy Cam 2 4 Assistoscope for assistant viewing 3 Install any one or two accessories on any side Left or rig...

Page 20: ...e of LED is above 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 THERMAL CUTT OFF TENSION ADJUSTMENT 19 6165000 795 PRIMA GN Refer fig 18 1 Remove plate by...

Page 21: ...amera control unit Release locks by pressing the upper parts of the locks downward Bring the unit into its moving position Be careful of heights when passing through doorways Avoid collision of any kind Do not go over steps and edges the stand might topple Be extremely careful when moving over slopes Do not park the stand on slopes Press lock downward Check whether the stand is locked in position ...

Page 22: ...uble shooting table attach a sign to the instrument stating out of order and contact our service representative for servicing part or circuit diagram etc Surgical Microscope Maintenance Servicing Check Care instructions o Keep accessories away from dust when not in use e g protect them from dust cover o Remove dust with a pneumatic rubber bulb and soft brush o Use special optics cleaning cloths an...

Page 23: ...kplace Remove surface contamination with a paper towel Reprocessing Recommended reprocess a product immediately after use or as when required as per below cleaning instructions Cleaning Servicing Needed water detergent spirits microfiber cloth o Take a Linen or any soft cloth Moist it slightly with running tap water 40 C using a little detergent and clean the metallic and plastic parts o Clean all...

Page 24: ...on and storage Temperature Rel humidity without condensation Air pressure 40 C 70 C 10 100 500hPa 1 060hPa The unit meets the essential requirements stipulated in Annex I to the 93 42 EEC directive governing medical devices The unit is marked with and is compliance CE to ANSI AAMI EC 60601 1 2005 23 6165000 795 PRIMA GN Issue 1 4 Printed onMarch 2016 ...

Page 25: ...DISPOSAL Prima GN Disposal must comply with locally applicable laws regulations 6165000 795 PRIMA GN Issue 1 4 Printed onMarch 2016 ...

Page 26: ...s level set too Adjust brightness using the Illumination low brightness control knob Light guide not properly Insert light guide properly to get inserted in arm or maximum illumination microscope Defective light guide Change light guide illumination not uniform TROUBLESHOOTING TABLE Inoperative surgical field illumination Light guide not properly inserted in microscope arm Insert light guide as fa...

Page 27: ... Loosen friction adjustment of screw on on suspension system screw on suspension system suspension system tightened too firmly as require too stiff Microscope Unstable Brakes on wheels not Use Brakes used No image visible in Magnichanger is not Index magnichanger properly field of view indexed properly Illuminate surgical field using alternate illuminator and contact service deartment 6165000 795 ...

Page 28: ...t source 50W LED Maximum intensity 80 000 LUX Built in filters Green Vertical movement of arm 550 mm Microscope carriers Straight Carrier Accessories Double Beam Splitter and Camera Adapters Power Consumption 130 W max Input Voltage 100V 240V 50 60 hz Stand Stable and sturdy H base stand with 2 lockable wheels Base Dimensions 600 mm width 620mm length Stand Height 984 mm Weight Microscope arm with...

Page 29: ...ns Test Compliance Electromagnetic Environment Guidance RF Emissions CISPR 11 Group 1 Class A The Prima GN uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Harmonics IEC 61000 3 2 Class A The Prima GN is suitable for use in all establishments other than domestic and those directly conne...

Page 30: ...that of a typical commercial or hospital environment Surge IEC 61000 4 5 1kv Differential 2kv Common 1kv Differential 2kv Common Mains power quality should be that of a typical commercial or hospital environment voltage Dips Dropout IEC 61000 4 11 95 Dip for 0 5 Cycle 60 Dip for 5 Cycles 30 Dip for 25 Cycles 95 Dip for 5 Seconds 95 Dip for 0 5 Cycle 60 Dip for 5 Cycles 30 Dip for 25 Cycles 95 Dip ...

Page 31: ...ths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance levels in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Radiated RF IEC 61000 4 3 80 MHz to 2 5 GHz 3V m E1 3 v m Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all sit...

Page 32: ... power of the communications equipment Max Output Power of Transmitter W Separation m 150kHz to 80 MHz d 3 5 v1 Sqrt P Separation m 80 to 800 MHz d 3 5 E1 Sqrt P Separation m 800MHz to 2 5GHz d 7 E1 Sqrt P 0 01 0 1166 0 1166 0 2333 0 1 0 3689 0 3689 0 7378 1 1 1666 1 1666 2 3333 10 3 6893 3 6893 7 3786 100 11 6666 11 6666 23 3333 For transmitters rated at a maximum output power not listed above th...

Page 33: ...Prima GN Colposcope with Mobile Stand Total Weight Approx 80 kgs Prima GN MEASURES WEIGHT 525 600 32 6165000 795 PRIMA GN Fig 22 Issue 1 4 Printed onMarch 2016 ...

Page 34: ...iconductor device that emits light when an electrical current passes through Eyepiece The optical portion facing towards the eyes with which the enlarged image produced by the colposcope can be viewed Beam path convergent The two light beams for the eyes run together in a point that lies at a distance of 300 mm in front of the front lens This distance is in accordance with the working distance Thi...

Page 35: ... special incidental or consequent damages for any negligence breach of warranty strict liability or any other damages resulting from or relating to design manufacture sale use or handling of the product PRODUCT CHANGES Labotech Microscopes India Pvt Ltd reserves the right to make changes in design or to make additions to or improvements in its products without obligation to add such to products pr...

Page 36: ...Microscopes India Pvt Ltd reserves the right to change design and specifications without prior notice Labo America Inc 920 Auburn Court Fremont CA 94538 U S A Telephone 510 445 1257 Fax 510 991 9862 sales laboamerica com Manufactured for A16372 LABOMED ISO 13485 ...

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