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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Issue 1.4
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LIST OF CONTENTS
1
2
6
7
3
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
3-5
8-10
11-12
13
3 1
1
14
15
16-17
18
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
18
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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15
6
7
3
10
5
17
9
8
16
12
14
18
2
1
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
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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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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.
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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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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. 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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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.
Prima GN
B
7.2 Make sure that during assembly of the column, ring
D) is fixed in place, as shown in Fig. 15
7.3 Retrieve the swivel arm and suspension arm
assembly from the packing box and follow
instruction as below (refer Fig. 3)
Ensure loosening of swivel arm lock knob( A).
Install the swivel arm assembly on the upright
Fig 13
C
Fig 14
D
Fig 15
3
2
A
holding shaft (1) figure 3.
Lock the swivel arm with threaded plug (2) from
the top.
Put protective cap (3) in place and loosen
suspension arm locking B knobs so that it can be
rotated.
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B
Fig. 3
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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
(2).
7.5 Mounting the light guide
Switch off the illumination system
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1
2
The light guide comes pre-routed through swivel
arm (that houses the LED illumination system)
and the 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 the binocular head and eyepieces on the
magni-changer. Secure the binocular head with
head locking screw shown as (A) in figure 6
Fig. 4
A
Fig. 5
A
6165000-795 PRIMA GN
Fig. 6
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ELECTRICAL CONNECTIONS
Connect the power cable to the AC inlet socket
(2) provided on the back of the swivel arm as
shown in the fig 7.
Switch on the power from on/off switch (1).
Note: Power supply is designed with universal
input 100V-240V AC, 50/60Hz. To plug in follow
instruction on electrical label provided at
bottom of the arm as shown (3) here in Fig. 7.
8.1 Replacing the illumination source
Open the swivel arm cover’s. Detach the fibre
optic cable and replace the illumination assembly
A with new assembly. Secure back the arm
cover’s.
Prima GN
1
2
3
Fig. 7
8.2 Fuse Replacement
The fuse is located with the AC inlet, provided
near the on/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
8.3 Data Plate for Prima GN Colposcope
UL Mark
Safety Certification
Device Name
Model Number
Serial Number
Input Voltage
Frequency
Max. Load
Separate Disposal
waste electric device
RX Only
Manufacturer
A
Fig. 8
On/off Switch
AC Inlet
Fig. 9
Accompanying Document
must be consulted
IEC60601-1:2005
Labeling for USA & Europe
IEC60601-1:2005
Labeling for Canada
Fuse Rating
Label Control
Number
Company
Trademark
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8.4 Prima Wiring Coding Diagram
Prima GN
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CONTROL ELEMENTS
9.1 ON/OFF switch (Shown as 1 in fig. 7
above)
Prima GN
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.
To save burning life of LED, switch OFF the
appliance if the microscope is not in use for
longer time.
9.2 Intensity control knob
It is located 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
B
A
Fig. 10
Locks the stand from unwanted movement by
pressing down the two brakes provided on caster
wheels. To unlock press upper portion of brake.
See Figure 11.
Fig. 11
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INSTRUCTIONS FOR USING THE COLPOSCOPE
WARNING: INSTRUMENT IS UNSAFE FOR MRI ENVIRONMENTS
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
preset as per the ordered configuration. Still
user can adjust up and down force by
tuning the allen screw clockwise or
anticlockwise with the help of a 8.0 mm
allen wrench.
Refer Fig. 12 to see the exact location of
tension adjusting screw.
A
Fig. 12
Prima GN
B
Tension
adjustment screw
3 Lock the Up & Down movement of
suspension arm using locking knob(B) in
fig. 12 after coarse focusing of the
attendance area.
4 Adjust the eye distance as per IPD scale
according to your convenience.
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. 13
3 Absolute centering of observation area in
field of view can be done by manual
handle(11c).
11d
11a
11c
Fig. 13
4 Make sure that the magnification changer is
engaged in the index point at the click stop
position.
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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).
Prima GN
Fig. 14
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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.
3. A range of objectives/eyepieces can be
selected by choice.
Prima GN
Fig. 15
USE OF ACCESSORIES
Fig. 16
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 right ) of the beam splitter
4. Reinstall binocular tube (straight or 45 degree inclined) on double beam splitter.
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Prima GN
THERMAL CUTT-OFF
Although instrument is designed for safe working condition thru sufficient cooling facility provided
with proper free and forced air circulation by the fans provided in electrical box. Further instrument
is designed with a inbuilt safety mechanism with “auto thermal cut-off” if the temperature 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
TENSION ADJUSTMENT
After Supplementary accessories are mounted,
the additional load of suspension arm must be
compensated by adjusting tension on tension
control screw provided on suspension arm by
moving it clock wise or anticlockwise.
Refer fig. 18
1. Remove plate by unscrewing two holes.
2. Loosen two allen bolts by using allen wrench of
4 mm as shown in fig 19
e hexagonal wrench of 8mm in bolt (A)
3. Us
shown in fig. 20 rotate it clockwise to increase
desired tension on Gas spring
4. Re tighten the two screws
5. Put back the plate
Fig. 18
Fig. 19
A
Fig. 20
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MOVING POSITION OF THE SYSTEM
Position of the system for
safe transportation.
Fold the system
as shown before
moving
Prima GN
Fig. 21
Relocating the stand
Turn off the unit at the power switch
Disconnect the power cable from line power.
Remove the video cable from the video modules (e.g. video monitor,
USB monitor, etc) and the camera 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.
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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. If a failure occurs which you cannot correct using the trouble-shooting table,
attach a sign to the instrument stating out of order and contact our service representative for servicing
part or circuit diagram etc.
Prima GN
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 and pure alcohol for cleaning lenses and eyepieces.
o Protect your colposcope from moisture, fumes, acids and cosmetic materials. Do not store chemicals
close to the instrument.
o Protect it from improper handling. Never install other devices sockets or unscrew optical system and
mechanical parts unless explicitly instructed to do so in this manual.
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o Protect the microscope from oil and grease. Never oil or grease the guide surfaces or mechanical parts.
o Remove coarse contamination using a damp disposable cloth.
o Use disinfectants based on the following ingredients: aldehydes, alcohols, quaternary ammonium
compounds.
o Camera: Clean optical components using a lint-free cloth. Soak the cloth using a little methanol or glass
cleaner. Do not use ethanol and spirit.
o Do
o LABOMED MaxLite coatings are fungal resistant. If you clean as described above, the coatings will
Tropical environment/fungus:
o Keep optical part clean.
o Use and store them in a clean environment only.
o Store under UV light when not in use.
o Use in continuously climate-controlled rooms only.
o Keep
not clean products
not be damaged.
LABOMED employs certain safety precaution in its manufacturing techniques and materials. Other
preventive measures include:
moisture away using silica gel and cover with a plastic cover.
and optical components in a cleaning/disinfecting device or ultra sound bath.
Occupational safety and health protection:
Observe work safety and health protection of persons responsible for processing contaminated
products.
Current regulations of hospital hygiene and prevention of infection must be observed in the
preparation, cleaning and disinfection of the products.
Instructions
• Workplace:
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 C
o Dry optical components using a microfiber cloth; dry
o For servicing as and when required, inform LABOMED after – sales service department.
• Autoclaving:
lean all optical components with spirits or alcohol.
the rest of the product using a paper towel.
The rubber caps, sleeves and grips supplied by labomed are recommend for the following program
for autoclaving:
Temperature:
Time:
Instrument:
134° C
10 minute
Standard, Autoclave
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AMBIENT REQUIREMENT
Prima GN
For operation Temperature
Rel.humidity
(without condensation)
Air pressure
For transportation
and storage
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
to . ANSI / AAMI EC 60601-1:2005
Temperature
Rel. humidity
(without condensation)
Air pressure
+10°C....+40° C
30%......90%
700hPa......1,060hPa
-40°C......+70°C
10%.......100%
500hPa.......1,060hPa
CE
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DISPOSAL
Disposal must comply with locally applicable laws & regulations.
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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 Contact in-house Technician
Failure of suspension Contact service dept.
s y s t e m e l e c t r o n i c s
Light guide not properly Insert light guide properly to get
inserted in arm or maximum illumination.
m i c r o s c o p e .
Prima GN
Insufficient Brightness 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
m i c r o s c o p e .
Defective light guide Change light guide.
(illumination not uniform)
Insert light guide as far as it will
go
Illumination surgical field using
alternate illuminator and contact
service dept.
Move suspension arm of
suspension system into working
position
Inoperative surgical
field illumination
Light guide not properly
inserted in microscope arm
Failure of electronics
Switch off via microswitch on
suspension system
6165000-795 PRIMA GN
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Issue 1.4
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P r o b l e m P o s s i b l e C a u s e R e m e d y
Thermal cut-off in lamp Clean thermal cut-off with a
housing is contaminated. dry brush; blow it clean, if
necessary
Prima GN
Defective fan. Failure of
system electronics.
Illuminate surgical field using
alternate illuminator and contact
service deartment
Up & Down motion Friction adjustment screw 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.
6165000-795 PRIMA GN
Issue 1.4
Printed on March, 2016
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
WF 12.5x/18mm; fixed eye guards .Optional:
Magnichanger 0.4x, 0.6x, 1.0x, 1.6x & 2.5x;5 step:
FOV (Field of View) 15°-2.5° (80-13 mm)
Objective f=300, manual fine focus
Light 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 all optical module 20 Kg. Approx.
H-base with pillar 60 Kg. Approx
Elevation Stroke: 570 mm
Stand Height in Horizontal Position: 775 mm
6165000-795 PRIMA GN
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Issue 1.4
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Guidance Tables
Guidance Tables
Guidance and Manufacturer’s Declaration
Electromagnetic Emissions
Prima GN
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.
Emissions Test Compliance
RF Emissions
CISPR 11
Harmonics
IEC 61000-3-2
Flicker
IEC 61000-3-3
Group 1
Class A
Class A
Complies
Electromagnetic Environment
- Guidance -
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.
The Prima GN is suitable for use in all
establishments,
directly connected to the public low-voltage power
network that supplies buildings used for domestic
purposes.
other than domestic, and those
28
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Issue 1.4
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Prima GN
Guidance Tables
(continued)
Guidance and Manufacturer’s Declaration
Electromagnetic Immunity
All Equipment and Systems
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
Test
ESD
IEC 61000-4-2
EFT
IEC 61000-4-4
Surge
IEC 61000-4-5
IEC 60601
Test Level
±6kv Contact
±8kv Air
±2kv Mains
±1kv I/Os
±1kv Diff erential
±2kv Com mon
Compliance
Level
±6kv Contact
±8kv Air
±2kv Mains
±1kv I/Os
±1kv Diff erential
±2kv Com mon
Electromagnetic
Environment
Floors should be wood, concrete or ceramic
tile. If floors are synthetic, the R/H should be at
least 30%.
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment.
- Guidance
voltage
Dips/Dropout
IEC 61000-4-11
Power Frequency
50/60Hz
Magnetic Field
IEC 61000-4-8
>95% Dip
for 0.5 Cycle
60% Dip
for 5 Cycles
30% Dip
for 25 Cycles
>95% Dip
for 5 Seconds
3A/m 3A/m
>95% Dip
for 0.5 Cycle
60% Dip
for 5 Cycles
30% Dip
for 25 Cycles
>95% Dip
for 5 Seconds
Mains power quality should be that of a typical
commercial or hospital environment. If the user
of the Prima GN requires continued operation
during power mains interruptions, it is recom-
mended that the Prima GN be powered from
an uninterruptible power supply or battery.
Power frequency magnetic fields should be that
of a typical commercial or hospital environment.
6165000-795 PRIMA GN
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Prima GN
Guidance Tables
(continued)
Guidance and Manufacturer’s Declaration
Electromagnetic Immunity
Equipment and Systems that are NOT Life-supporting
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
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
IEC 60601
Test Level
3 vrms
150 kHz to 80
MHz
80 MHz to 2.5
GHz @ 3V/m
Compliance
Level
(v1) = 3 vrms
(E1) = 3
v/m
Portable and mobile RF communications
equipment should be used no closer to any
part of the Prima GN , including cables,
than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter.
Recommended Separation Distance:
Electromagnetic
Environment
d=(3.5/v1)(Sqrt P)
- Guidance
d=(3.5/E1)(Sqrt P)
80 to 800 MHz
d=(7/E1)(Sqrt P)
800 MHz to 2.5 GHz
Where P is the max output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the recommended separation distance in meters (m).
Field strengths 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 .
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures objects and people.
* Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and Tv broadcast cannot be predicted theoretically
i
th accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic
w
site survey should be considered. The measured field strength in the location in which the ME Equipment or
ME System should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the ME Equipment or ME System.
* Over the frequency range 150 kHz to 80 MHz, field strengths should be less then [V1] V/m.
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6165000-795 PRIMA GN
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Prima GN
Guidance Tables
Recommended Separation Distances between
(continued)
Portable and Mobile RF Communications Equipment and the Prima GN for
ME Equipment and ME Systems that are NOT Life-supporting.
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
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
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 communications equipment.
Max Output Power
of Transmitter
(W)
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, the recommended separation distance (d)
in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (w) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects, and people.
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)
6165000-795 PRIMA GN
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MEASURES & WEIGHT
Prima GN- Colposcope with Mobile Stand
Total Weight: Approx. 80 kgs.
Prima GN
525
600
Fig. 22
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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).
Colour temperature T F Specifies the colour impression of a light source. Using colour temperature,
one can set the colour of a light source in relation ('hot' or 'cold' light) with
the colour of natural light (sunlight). The unit of measurement for colour
temperature is Kelvin (K).
Light field diameter The size of the field, which is illuminated at a distance of 300 mm.
Field of view diameter The visible area of an object that can be seen through the colposcope. The
greater the magnification level, the smaller the field of view and vice versa.
Green filter A colour filter that darkens red and blue light and brightens green light.
Thus, the contrast of the image is increased, blood vessels are shown more
clearly.
Intensity of Illumination
LED Light Emitting Diode. Electronic semiconductor device that emits light when
Eyepiece The optical portion facing towards the eyes, with which the enlarged image
Beam path, convergent
White Balance White balance is used to calibrate the camera to the colour temperature of the
DSLR Camera (Digital single-lens reflex camera) with a digital imaging sensor.
CCD Camera (Charge-coupled device) a camera with a technology to store electro charge
Specifies the luminous flux from a light source onto a certain area. The unit
of measurement for illumination intensity is lux (Abbrev.: lx).
an electrical current passes through.
produced by the colposcope can be viewed.
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. This way, the eye does not has to focus on this point on its
own, as it is the case with a parallel beam path.
light at the location.
and move this charge out of photo sensor in organized way.
CMOS Camera (Complementary Metal Oxide Semiconductor) cameras in which image sensors
are silicon chips that capture and read light.
DBS (Double beam splitter) Splits each light beam into two directions (eye and to
side port) for simultaneous user view & photography, videography or co-
observations.
Ratio of light distribution is 70% for eyes & 30% to side ports for photography,
videography or co-observations, installed between observation head and main
microscope.
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Issue 1.4
Prima GN
WARRANTY
This product is warranted by Labotech Microscopes India Pvt. Ltd. against defective material and
workmanship under normal use for a period of one year from the date of invoice to the original
purchaser. (An authorized dealer shall not be considered an original purchaser). Under this warranty,
Labotech Microscopes India Pvt. Ltd. sole obligation is to repair or replace the defective part or product
at Labotech/Labomed discretion.
This warranty applies to new products and does not apply to a product that has been tampered with,
altered in any way, misused, damaged by accident or negligence, or which has had the serial number
removed, altered or effaced. Nor shall this warranty be extended to a product installed or operated in a
manner not in accordance with the applicable LABOMED instruction manual, nor to a product which
has been sold, serviced, installed or repaired other than by a Labotech Microscopes India Pvt. Ltd.
factory or authorized LABOMED Dealer.
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.
This warranty is in lieu of all other warranties implied or expressed. All implied warranties of
merchantability or fitness for a particular use are hereby disclaimed. No representative or other person
is authorized to make any other obligations for a LABOMED product. Labotech/Labomed shall not be
liable for any 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 previously
manufactured.
CLAIMS FOR SHORTAGES
We use extreme care in selection, checking, rechecking and packing to eliminate the possibility of
error. If any shipping errors are discovered:
1. Carefully go through the packing materials to be sure nothing was inadvertently overlooked when
the unit was unpacked.
2. Call the dealer you purchased the product from and report the shortage. The materials are packed
at the factory and none should be missing if the box has never been opened.
3. Claims must be filed within 30 days of purchase.
CLAIMS FOR DAMAGES IN TRANSIT
Our shipping responsibility ceases with the safe delivery in good condition to the transportation
company. Claims for loss or damage in transit should be made promptly and directly to the
transportation company.
If, upon delivery, the outside of the packing case shows evidence of rough handling or damage, the
transportation company's agent should be requested to make a “Received in Bad Order” notation on
the delivery receipt. If within 48 hours of delivery, concealed damage is noted upon unpacking the
shipment and no exterior evidence of rough handling is apparent, the transportation company should
be requested to make out a “Bad Order” report. This procedure is necessary in order for the dealer to
maintain the right of recovery from the carrier.
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Issue 1.4
6165000-795 PRIMA GN
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labomed
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:
Labo America Inc.
920 Auburn Court
Fremont
CA 94538
U.S.A.
Telephone: 510 445 1257
Fax: 510 991 9862
sales@laboamerica.com
A16372
ISO 13485
LABOMED
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