Prima C/ Prima CS
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:6128000-795
Issue on 2.0 Printed
on Oct, 2016
List of Contents
1. Introduction
User’s Manual Prima C/ Prima CS COLPOSCOPE
2
2. Warning & Caution/Warning labels/Intended use
3. Condition of material at time of supply
4. Installation Instructions Prima C
4.1
4.2
Mounting of Roller Stand and Column
Mounting of Appliance
5. Installation Instructions Prima CS
5.1 Special Instructions
5.2 Additional Load
6. Demensions & Weight Prima C
7. Demensions & Weight Prima CS
8. Electrical connections Prima C
9. Operating Instructions Prima C
9.1 On / Off Switch
9.2 Brightness control
6-9
10
11 - 12
11
12
13 - 14
13
14
15
15
16
17
17
17
10. Control elements Prima C / CS
11. Instructions for using Microscope
a. Adjustment of Interpupillary Distance
b. Changing the magnification
c. How to focus the object
d. Red free image observation
e. Eyepieces with dioptre
12. Changing the Objective / Eyepieces
13. Care and Maintenance
14. Schedule of autoclavable caps Prima C
15. Schedule of autoclavable caps Prima CS
16. Ambient requirement
17. Disposal
18-19
20 - 24
20
21
22
23
24
25
26-27
28
39
30
30
18. Technical Specifications Prima C / CS
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1. INTRODUCTION
Congratulation on the purchase of your new Prima C/ Prima CS COLPOSCOPE.
This instruction manual is designed as a training and reference manual for the operation and
maintenance of the instrument. We recommend that you read it carefully prior to use and follow the
instruction to ensure optimum performance of your new instrument.
Please retain this manual for future reference and to share with other users. Additional copies can be
obtained from our authorized LABOMED dealer or from the LABOMED service department. Contact
information is provided at the end of this guide.
LABOMED Prima C / Prima CS COLPOSCOPE is an optical instrument used in a medical diagnostic
procedure to examine Cervix, Vaginal and Vulva tissue with the aid of illumination techniques and optical
stereo microscope.
A Colposcope provides an enlarged view of area of interest and allows visual distinguishing of normal and
abnormal appearing tissues and also as an aid of taking direct biopsies for further pathological
examination.
It is also used for visual examination of Cytological abnormality as well as assessment of Diethylstilbestrol
exposure in-utero, Immuno suppression such as HIV, abnormal appearance of the Cervix and forensic
examination of a sexual assault.
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Important general references
Preliminary notes
LABOMED is renowned for providing innovative technologies and products in women’s healthcare. PRIMA
C / Prima CS colposcopes were developed in cooperation with practicing gynecologists. Experience,
precision, and continuous manufacturing optimization has enabled LABOMED to became the leading
manufacturer of colposcopic precision instruments, with the largest product range of colposcopes in the
world.
Determination-Appropriate Use
Only LABOMED accessories, bases, and source of light may be utilized with LABOMED colposcopes.
Restrictions, which are stipulated in the directions for use, are to be considered.
The device is designed for application in medical practices and/or clinics.
According to the stipulation of the MPG (German Medical Device Law), colposcopes may be operated
only by those persons who have been instructed in the expert handling of the device.
The proper installation and maintenance of the device are vital prerequisites before using the colposcope.
The user should check the functional stability and proper condition of the device before every procedure.
Indications for use
A colposcope may be helpful in the following situation:
1. Major abnormality on pap smear
2. Persistent minimal abnormality on pap smear
3. Abnormalities of squamous or columnar cells
4. Persistence of an inflammatory appearance of the smear despite adequate treatment
5. Presence of keratinized cells suggestive of leukoplasia
6. Symptoms of metrorrhagia, in particular contact bleeding
7. Abnormalities appearance of cervix or vagina by naked eye examination
8. Evaluation after exposure to diethylstilbestrol(DES) or related drugs during embryogenesis
9. Monitoring after treatment of dysplasia, regardless of treatment method
10. Evaluation of anogenital condylomatosis
11. Evaluation of vulvo-perineal bowenoid papulosis
12. Preoperative evaluation before genital-tract surgery: hysterectomy, treatment of genital prolapse,
cervicovaginal plastic surgery, etc.
13. Lesion noted on routine gynecologic examination
Contraindications for use
The colposcope is a device for viewing the body from a distance and is not intended for patient
contact. Because of this there are no contraindications for use of a colposcope.
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How to read these operating instructions
These instructions are structured around the operation of the colposcope, from assembly to the
finished system. Basic troubleshooting information is also provided. Our goal is to make these
instructions easily understandable and technically feasible.
The instruments contents follow the structure of a colposcope: head, base, accessories, electrics,
maintenance and safety.
The inside edge of each page is exclusively reserved for important key words, symbols and
provides sufficient space for your personal notes.
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Prima C: Ergonomic stand for easy and accurate positioning. It has a vertical travel of 100 mm.
Control knob helps user in achieving the desired height by slightly loosening the swivel
arm locking knob and then re-clamping after getting the required height.
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Prima CS:
Colposcope can be positioned easily with the help of a suspension arm within
a vertical travel range of 500mm. It can be maneuvered easily with the help
of a 980mm long pentographic arm as per user & patient comfort. When not in
use, colposcope can be folded easily over the main body to store compactly.
Binocular Head
Binocular Head Locking Screw
Fine Focusing Knob
Eyepieces
Suspension arm hydraulic movement knob
Joystick
Potentiometer Knob
Microscope ArmLocking knob
CMO
Magnification Knob
Tilt Locking Knob
Suspension arm apring
Tension Adjustment
Swivel Arm Cover
Suspension arm
Column
Base
5
Wheels
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2. 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: 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 OTHERWISE 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 OTHERWISE SERIOUS INJURY TO THE
OPERATOR OR PATIENT MAY OCCUR.
WARNING: IF THIS INSTRUMENT IS MODIFIED, APPROPRIATE INSPECTION AND TESTING MUST
BE CONDUCTED TO ENSURE 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 OTHERWISE 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
INDICATED ON THE DATA PLATE OTHERWISE DAMAGE TO THE UNIT MAY OCCUR. TO USE IN
FLUCTUATION VOLTAGE ENVIRONMENT CONSTANT VOLTAGE STABILIZER IS RECOMMENDED
FOR SAFE & EFFICIENT USE OF DEVICE.
WARNING: THIS INSTRUMENT MUST BE PLUGGED IN TO AN OUTLET WITH AN EARTH
GROUND. DO NOT REMOVE, DAMAGE OR DEFEAT THE EARTH GROUND CONNECTION NEITHER
ON POWER INPUT CONNECTOR NOR ON THE POWER CORD SUPPLIED WITH THIS INSTRUMENT
OTHERWISE INJURY TO THE OPERATOR OR PATIENT MAY OCCUR.
6
WARNING: THE EQUIPMENT OR SYSTEM SHOULD NOT BE USED ADJACENT TO OR
STACKED WITH OTHER EQUIPMENT AND IF ADJACENT OR STACKED USE IS NECESSARY, THE
EQUIPMENT OR SYSTEM SHOULD BE OBSERVED TO VERIFY NORMAL OPERATION AND DESIRED
OUTPUT.
WARNING: THIS INSTRUMENT IS NOT SUITABLE FOR USE IN THE PRESENCE OF
FLAMMABLE ANESTHETIC MIXTURES, SUCH AS OXYGEN OR NITROUS OXIDE.
WARNING: BECAUSE PROLONGED INTENSE LIGHT EXPOSURE CAN BE HARMFUL TO
THE SENSITIVE TISSUES. THE USE OF THE DEVICE FOR EXAMINATION SHOULD
NOT BE UNNECESSARILY PROLONGED, AND THE BRIGHTNESS SETTING SHOULD NOT
EXCEED WHAT IS NEEDED TO PROVIDE CLEAR VISUALIZATION OF THE TARGET.
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WARNING: THE USE OF ACCESSORIES OR CABLES OTHER THAN THOSE SPECIFIED, AND USE OF
REPLACEMENT PARTS OTHER THAN SUGGESTED BY THE LABOMED, MAY RESULT IN INCREASED
EMISSIONS OR DECREASED IMMUNITY OF THE EQUIPMENT OR SYSTEM.
CAUTION: AN INSTRUCTION THAT DRAWS ATTENTION TO THE RISK OF DAMAGE TO 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 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 THIS DOCUMENT.
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: THIS INSTRUMENT IS NOT INTENDED TO BE CONNECTED TO EQUIPMENT OUTSIDE
THE CONTROL OF LABOMED OR OTHERWISE MUST BE TESTED TO APPLICABLE IEC OR
ISO STANDARDS.
CAUTION: HEIGHT ADJUSTMENT KNOB HAS A SPRING LOADED MECHANISM TO ADJUST
COLPOSCOPE HEIGHT. CARE MUST BE TAKEN TO AVOID INJURY TO PATIENT AND USER WHO IS
OPERATING THIS KNOB.
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Warning Labels and Notes
Year of manufacture used on PRODUCT DATA
PLATE
Fragile
- contents of the transport package are fragile and therefore shall be
Rx O
nly
Caution
Warning
Brightness control
Accompanying documents must be consulted
Catalog number
Compliance to medical device directive 93/42/EEC
Protective earth
This way up- indicates correct upright position of the transport package.
Keep dry- transport package shall be kept away from rain.
I O
S/N
EC REP
Connection ON / OFF
Alternating Current Power
handled with care
Caution: U.S. Federal law restricts this device to sale by or on the order of a
physician.
Serial Number
Authorized European Representative
Waste of Electrical and Electronic Equipment
Accompanying Documents must be consulted.
Temperature Range
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Directives and standards
CE Certification
The device is tested according to the specifications of the European Medical Device Directive [MDD]
93/42/EEC, and fulfills the necessary standards concerning the German Medical Product Law. This
product belong to Class I of non-invasive products, according to Appendix IX of EU Guideline
93/42/EEC and checked for compliance with the basic requirements according to Appendix I of
Guideline 93/42/EEC. All the colposcopes provided with the CE mark which indicates agreement with
the legal stipulations.
Quality Management
LABOMED has an established quality management system according to ISO 9001:2008 /
13485:2004 and USFDA 21 CFR 820 cGMP requirements. Regular internal auditing is the key for
continuous improvements. Monitoring by authorized external auditors guarantees the agreement with
the respective international standards.
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 60601-1-3rd 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.
• Please observe all applicable accidental prevention regulations.
• Intended Use
LABOMED colposcopes Prima C / CS 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
abnormilities and select areas for biopsy. It helps the user an excellent level of comfort and
improves visual acuity during use.
• Note: The use of Prima C / CS Colposcope is purely for intended Operative and Diagnostic
medical use. No contact is to be made between the patient and the device.
• Configuration:
Microscope Catalogue No.
PRIMA C 6128000
PRIMA CS 6128600
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3. CONDITION OF MATERIAL AT TIME OF SUPPLY
Prima C
The appliance is delivered in 6 assembled groups:
• Mobile supporting Base ( Assembled) as shown in Fig. 1. Page 12
• Column (as shown in Part 1. Page 12)
• Illumination box with integrated electrical power supply (Refer Fig. 2.1 Page 13)
• Microscope Arm (Refer Fig. 2.2 Page 13)
• Microscope Head with Eyepieces (Inclined or Straight) Refer Fig. 2.13 Page 21
Fasteners are enclosed in the packing box.
Prima CS
The appliance is delivered in 5 C Boxes:
Three Boxes containing
• Wheel Support Base (Left)
• Wheel Support Base (Right)
• Centre Support Base
One Box containing
• Column
• Microscope Arm with integrated illumination box
One Box containing
• Carrier Assembly
• Microscope Head (Inclined or Straight)
• Eyepieces
Fasteners are enclosed in the packing box.
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4. INSTALLATION INSTRUCTIONS OF PRIMA C
4.1 MOUNTING OF ROLLER STAND AND COLUMN (Fig. 1)
• Insert column① into the mobile base②.
• Fasten screw ③ with enclosed hexagon socket wrench to column ①.
• The mobile bases have 5 rollers④ out of two have locking breaks(red)
11
(Fig. 1)
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4.2 MOUNTING OF APPLIANCE
Mount the illumination box ③ to the column against the vertical guide ②.
Screws ① to be tighten to hold the box as shown (Fig. 2.1).
(Fig 2.1)
Insert the arm ④ of the microscope head on the top of the column ⑤.
Screws ⑥ to be tightened from both sides of the head arm④.
12
(Fig. 2.2)
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5. INSTALLATION INSTRUCTIONS OF PRIMA CS
• Install the Left wheel support (A) and Right wheel support (B) on the centre support base (C) by
tighten the allen screws (1) provided from the bottom of metal plate. Refer Fig. 2.3
• Install the column (D) on the base. Engage the column to the indexing screw (E). Align the
tapped hole of the Column in the screw seat, hold the column firmly and tighten the allen screw
(2) from the bottom of the base. Refer Fig. 2.3
D
B
A
C
1
1
2
(Fig. 2.3)
• Ensure loosening of Swivel arm lock knob (E) and Install the Swivel arm & Suspension arm
assembly on the upright holding shaft (3). Refer Fig. 2.4
• Lock the Swivel arm with threaded screw (4) from the top. Refer Fig. 2.4
4
E
3
13
(Fig. 2.4)
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• Retrieve the carrier assembly from the packing and follow as below. refer Fig. 2.5
• Install the coupling to the suspension arm by sliding the guiding shaft (5) in to the suspension
arm.
• Lock the inclined coupling with the threaded plug (6).
• Secure the Flat Head Safety Screw (M5) using a flat head screw driver in the socket situated in
Suspension arm front coupling as shown as (7) in fig. 2.5. The same is hanged with a tie to
potentiometer knob
5
6
7
Fig. 2.5
5.1
The joint which connects swivel arm and the column is fitted with a stop to prevent the inner
The total rotation of the swivel arm is not more than 180° to the column.
On reaching the stop, do not rotate further, to prevent any tear off or damage to the mechanism.
5.2
• The load capacity and tilting stability is balanced with a Max. 9.0 Kg load with standard
• Please do not attach additional load.
Special Instruction:
assembled cables.
ADDITIONAL LOAD
supplied parts and accessories.
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6. DIMENSIONS & WEIGHT (Fig. 2.6) Prima C
Colposcope with roller star base stand
Total weight: Approx. 45 kg.
7. DIMENSIONS & WEIGHT (Fig. 2.6)
(Fig. 2.6) Prima C
Prima CS Colposcope with H Base Stand
Total weight: Approx. 86.5 kg.
Three Boxes containing:
Base left wheel support: 20 Kg
Base right wheel support:20 Kg
Base centre Support: 20 Kg
One Box Containing:
Column: 8 Kg
Microscope Arm: 15 Kg
One Box Containing:
Carrier Assembly: 2.5 Kg
Microscope Head: 600 Gms
Eyepieces and Accessories: 400Gms
(Fig. 2.7) Prima CS
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8. Electrical Connections Prima C
Connect the power cable to the AC Inlet socket as 1 in figure number 2.8 below.
Switch on the power from on/off switch shown as 1 in figure number 2.9 on page no. 18.
Note: Power supply is designed with universal input 100V-240V AC, 50/60Hz. To plug in follow
instruction on electrical label provided at back of illumination box as shown in figure number 2.8 below.
a) CHANGING OF FUSE
• Note: Fuses are in fuse holder:
F 2.8 (2 mains input fuses for lamp supply for mains voltage 100-240 V)
• Changing of Fuse: Draw out the plug. Insert a screw driver into the slit of fuse holder and screw out to
the left. Remove cap and replace the fuse placed in it. Once the fuse is replaced cap it again and screw
in to the right. Refer electronical label for correct fuse replacement
• Attention: Fuses are allowed to change against the specified type only.
(Fig. 2.8)
Fuse Inside
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9.
OPERATING INSTRUCTIONS Prima C
9.1
9.2
On / off switch shown as ① in fig. 2.9 is located on the upper side of the illumination box. After the
appliance is switched on, the green illumination switch diode indicates that the microscope is ready for
operation. The LED starts burning and the cooling fan starts working.
BRIGHTNESS CONTROL shown as ② facilitates variation in light intensity is made by rotating knob.
Note:
To maximize LED life, switch off the microscope when not in use.
17
(Fig. 2.9)
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10. CONTROL ELEMENTS Prima C (Fig. 2.10 & 2.11)
Roller stand:
5 rollers to move the appliance and 2 brakes to lock the Appliance (see Fig. 1)
Rotating knob to change the Magnification ①.
Common Main Objective (CMO) ②.
Fine focusing knob ③.
Joystick to tilt the head arm forward and backward ④.
Head arm locking knob ⑤.
Knob to lock the arm ⑥.
Knob to swing in green filter ⑦.
Column height adjustment knob ⑧.
18
(Fig. 2.10)
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Power Supply Box ⑨.
Knob for brightness control ⑩.
Control Elements Prima CS
(Fig. 2.11)
• Suspension arm hydraulic movement knob ⑪.
• Suspension arm spring Tension Adjustment ⑫.
• Microscope arm locking knob ⑬.
• Suspension arm locking knob ⑭.
• Swivel arm locking knob ⑮.
• Potentiometer Knob
• Joystick Handle
• Magnichanger locking knob
17
18
15
12
• Magnification knob 1 9
• Fine Focusing knob
• Head Locking knob
20
21
21
11
20
19
18
17
16
(Prima CS)
19
14
(Fig. 2.12)
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11. INSTRUCTIONS FOR USING THE MICROSCOPE
a) ADJUSTMENT OF INTERPUPILLARY DISTANCE (Fig. 2.13)
Turn the microscope in working position.
Inclined tube 45°①: Adjust eyepieces ②to the required IPD by turning the lateral knob③.
Straight tube④: Adjust eyepieces ⑤ by moving the binocular tube as per your requirement.
2
4
1
5
3
(Fig. 2.13)
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b) CHANGING THE MAGNIFICATION (Fig. 2.14)
• Adjust to the highest magnification with any of the rotating knobs ① on the magnification changer.
• See to it that the magnification step changer is engaged into its index position, related to the desired
magnification.
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(Fig. 2.14)
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c) HOW TO FOCUS THE OBJECT (Fig. 2.15)
• Bring object into rough focus using arm movements.
• Rotate fine focusing knob 2 clockwise or anticlockwise to bring object into sharp focus.
• If the object is outside the range of the fine focusing knob, bring the complete microscope in the focus
range by any of the following means:
a) Roll the mobile stand forward and backward.
b) Adjust the arm towards left - right and up - down.
c) Adjust the microscope angle left and right. For this loosen the head arm knob and rotate the microscope.
A combination of the above steps will give you the true desired focusing median.
• On focusing the region of interest, change magnification through the magnification changing knob 1.
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(Fig. 2.15)
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d) Red free image observation (Fig. 2.16)
• Swing filter knob (1) to swing in or swing out the red free (Green) filter. This will help in filtering the
red tissue in the image being observed and will highlight the enhance vessel image and the vascular
morphology.
(Fig. 2.16)
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e) EYEPIECES WITH DIOPTER (Fig. 2.17)
• You can adjust the diopter settings as per your vision correction.
• Diopter adjustment is +/- 5 D
(Fig. 2.17)
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12. CHANGING THE OBJECTIVE / EYE PIECES(Fig. 2.18)
• The objective (1) has screw type mounting. Unlock it by turning anti-clock wise and lock by
turning clock wise.
• Eyepieces (2) are insertable. Pull out for changing.
• Other objectives / eyepieces can be selected by choice.
25
(Fig. 2.18)
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13. CARE & MAINTENANCE (Fig. 11)
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.
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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User’s Manual Prima C/ Prima CS COLPOSCOPE
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 not clean products and optical components in a cleaning/disinfecting device or ultra sound bath.
o LABOMED MaxLite 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 and materials. Other
preventive measures include:
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 moisture away using silica gel and cover with a plastic cover.
Occupational safety and health protection:
bserve work safety and health protection of persons responsible for processing contaminated
O
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 Clean all optical components with spirits or alcohol.
o Dry optical components using a microfiber cloth; dry the rest of the product using a paper towel.
o For servicing as and when required, inform LABOMED after – sales service department.
• Autoclaving:
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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COLPOSCOPE
14. Schedule of Autoclavable caps Prima C
Autoclavable caps:
(C1) Part no. 6122015-209
(C2) Part no. 6168000-219
(C3), (C4) Part no. 6168000-213
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6128000-795 Prima C/CS
(Fig. 2.19)
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User’s Manual Prima C/ Prima CS COLPOSCOPE
15. Schedule of Autoclavable caps Prima CS
Autoclavable caps:
(C5), (C6), (C8) Part no. 6122015-209
(C7) Part no. 6168000-219
(C9), (C10), (C11), (C12) Part no. 6168000-213
C5
C6
C7
C9
C12
C8
C10
C11
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16. Ambient Requirement
For Operation
Temperature
+10
˚ C….
+40
˚ C
For transportation and
Temperature
-
40
˚C…….+70˚C
storage
17. DISPOSAL
Disposal must comply with locally applicable laws & regulations
Rel. humidity
(without condensation )
Air Pressure
Rel. humidity
(without condensation )
Air Pressure
30%........90%
700hPa…..1,060hPa
10%.........100%
500hPa……1,060hPa
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18. TECHNICAL SPECIFICATION
Prima C
• Star Base Stand & Column, lockable wheels.
• Straight Observation tube, interpupillary distance 50-75mm. Optional: 45˚ inclined.
• WF 10/18mm FOV, focusable eyepieces with retractable eye guards, diopter adjustment +/- 5mm
Optional: WF 12.5x/18mm.
• 5-step magnification: 0.4x, 0.6x, 1.0x, 1.6x, 2.5x.
• F-300mm objective. Optional: f-400mm.
• Built-in-green filter
• Inbuilt 27W LED (5700K)
• 60W max power consumption.
• 100V-240V; 50/60 hz, voltage input. Fuse F2.5 Amp.
NOTE: For Safety & Warranty Claims Eligibility
Use constant voltage stabilizer to avoid sudden input voltage variation and to enhance LED life.
Prima CS
• H Base Stand & Column, lockable wheels.
• Straight Observation tube, interpupillary distance 50-75mm. Optional: 45˚ inclined.
• WF 10/18mm FOV, focusable eyepieces with retractable eye guards, diopter adjustment +/- 5mm
Optional: WF 12.5x/18mm.
• 5-step magnification: 0.4x, 0.6x, 1.0x, 1.6x, 2.5x.
• F-300mm objective. Optional: f-400mm.
• Built-in-green filter
• Inbuilt 27W LED (5700K)
• 60W max power consumption.
• 100V-240V; 50/60 hz voltage input. Fuse F2.5 Amp.
NOTE: For Safety & Warranty Claims Eligibility
Use constant voltage stabilizer to avoid sudden input voltage variation and to enhance LED life.
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labomed
Our policy is one of continuous development. Labotech Microscopes India Pvt. Ltd., reserves the right to change design and specification 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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