Labomed Prima C User manual

Part No:6128000-795
Issue on 2.0 Printed
on Oct, 2016
Prima C/ Prima CS
To ensure proper useof this instrument as well as to avoid injury while operating
instrument, understanding this manual completely before use is highly
recommended.
U.S. Federal law restricts this device to sale by or on the order of a licensed
physician. Rx only
Caution:

User’s Manual Prima C/ Prima CS COLPOSCOPE
6128000-795 Prima C/ Prima CS
Issue 2.0
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List of Contents 2
6-9
10
1. Introduction
2. Warning & Caution/Warning labels/Intended use
3. Condition of material at time of supply
4. Installation Instructions Prima C 11 - 12
Mounting of Roller Stand and Column 11
4.1
15
16
17
18-19
20 - 24
21
22
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
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. Technical Specifications Prima C / CS
23
24
25
26-27
28
39
30
4.2Mounting of Appliance 12
13 - 14
13
14
15
17
17
20
30
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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 avertical 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:
Binocular Head Locking Screw
CMO
Binocular Head
Eyepieces
Joystick
Microscope ArmLocking knob
Fine Focusing Knob
Magnification Knob
Tilt Locking Knob
Suspension arm hydraulic movement knob
Suspension arm apring
Tension Adjustment
Base
Wheels
Column
Swivel Arm Cover
Suspension arm
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.
Potentiometer Knob
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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 THATTHIS
DEVICE BE PURCHASED ONLYBY APHYSICIAN OR APERSON 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 AMANNER 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.
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) THATMAYBE 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
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 Connection ON / OFF
Year of manufacture used on PRODUCT DATA
PLATE
Alternating Current Power
Fragile
-
contents of the transport package are fragile and therefore shall be
handled with care
R
x
O
n
l
y
Caution: U.S. Federal law restricts this device to sale by or on the order of a
physician.
S/N Serial Number
EC REP
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: FDAclassification Class II
•Please observe all applicable accidental prevention regulations.
•Please observe all applicable accidental prevention regulations.
•Intended Use
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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
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 C
Prima CS
The appliance is delivered in 5C 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 column①into the mobile base②.
•Fasten screw ③with enclosed hexagon socket wrench to column ①.
•The mobile bases have 5 rollers④out of two have locking breaks(red)
(Fig. 1)
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4.2 MOUNTING OF APPLIANCE
Mount the illumination box ③to the column against the vertical guide ②.
Screws ①to be tighten to hold the box as shown (Fig. 2.1).
(Fig 2.1)
Insert the arm ④of the microscope head on the top of the column ⑤.
Screws ⑥ to be tightened from both sides of the head arm④.
(Fig. 2.2)
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•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
(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
(Fig. 2.4)
B
AC
1
1
D
2
3
4
E
5.INSTALLATION INSTRUCTIONS OF PRIMA CS
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5.1 Special Instruction:
The joint which connects swivel arm and the column is fitted with a stop to prevent the inner
assembled cables.
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 ADDITIONAL LOAD
•The load capacity and tilting stability is balanced with a Max. 9.0 Kg load with standard
supplied parts and accessories.
•Please do not attach additional load.
•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
Fig. 2.5
5
67
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6.DIMENSIONS & WEIGHT (Fig. 2.6) Prima C
Colposcope with roller star base stand
Total weight: Approx. 45 kg.
(Fig. 2.6) Prima C
(Fig. 2.7) Prima CS
7.DIMENSIONS & WEIGHT (Fig. 2.6)
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
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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.
9.1
9.2
OPERATING INSTRUCTIONS Prima C
On / off switch shown as ①in fig. 2.9is 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 ②facilitates variation in light intensity is made by rotating knob.
Note: To maximize LED life, switch off the microscope when not in use.
(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.
(Fig. 2.10)
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