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Prima C/ Prima CS
COLPOSCOPE
User Manual
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 2.2
Printed on November,2020
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Table of Contents
Related Manuals for Labomed Prima C
Summary of Contents for Labomed Prima C
- Page 1 Prima C/ Prima CS COLPOSCOPE User Manual Caution: Part No.: 6128000-795 U.S. Federal Law restricts this device to sale by or on the order of a licensed Issue 2.2 Physician. Rx only Printed on November,2020 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.
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Page 2: Table Of Contents
Eyepieces with diopter Changing the Objective/ Eyepieces Use of Accessories Care and Maintenance 29 - 30 Cleaning and Disinfection Schedule of autoclavable caps Prima C Schedule of autoclavable caps Prima CS Ambient requirement Disposal Technical Specifications Prima C/ CS 6128000-795 Prima C/ Prima CS Issue 2.2... - Page 3 LABOMED dealer or from the LABOMED service department. Contact information is provided at the end of this guide. LABOMED Prima C/ 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.
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Page 4: Introduction
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. - Page 5 Prima C/ Prima CS COLPOSCOPE INTRODUCTION (continued) 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.
- Page 6 Prima C/ Prima CS COLPOSCOPE INTRODUCTION (continued) Prima C: Ergonomic stand for easy and accurate position. It has a vertical travel of 100mm. 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.
- Page 7 Prima C/ Prima CS COLPOSCOPE INTRODUCTION (continued) 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 &...
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Page 8: Warning & Caution/Warning Labels/Intended Use
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 PERSONAL OR DEALERS WHO ARE TRAINED BY LABOMED OR SERIOUS INJURY TO THE OPERATOR OR PATIENT MAY OCCUR. - Page 9 EQUIPMENT. CAUTION: THIS INSTRUMENT IS NOT INTENDED TO BE CONNECTED TO EQUIPMENT OUTSIDE THE CONTROL OF LABOMED OR MUST BE TESTED TO AN 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.
- Page 10 Prima C/ Prima CS COLPOSCOPE WARNING LABELS AND NOTES Caution Warning Brightness control Accompanying documents must be consulted Catalog number Compliance to medical device directive MDR 2017/745 Protective earth This way up- indicates correct upright position of the transport package.
- Page 11 • Please observe all applicable accident prevention regulations. INTENDED USE LABOMED Colposcope 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 abnormalities and select areas for biopsy.
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Page 12: Condition Of Material At Time Of Supply
Prima C/ Prima CS COLPOSCOPE 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) •... -
Page 13: Installation Instructions Prima C
Prima C/ Prima CS COLPOSCOPE INSTALLATION INSTRUCTIONS OF PRIMA C 4.1 MOUNTING OF ROLLER STAND AND COLUMN (Fig. 1) • Insert column (1) into the mobile base (2). • Fasten screw (3) with enclosed hexagon socket wrench to column (1). -
Page 14: 4.2 Mounting Of Appliance
Prima C/ Prima CS COLPOSCOPE INSTALLATION INSTRUCTIONS OF PRIMA C (continued) 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). -
Page 15: Installation Instructions Prima Cs
Prima C/ Prima CS COLPOSCOPE 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 •... -
Page 16: Special Instructions
Prima C/ Prima CS COLPOSCOPE INSTALLATION INSTRUCTIONS OF PRIMA CS (continued) • 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 suspension •... -
Page 17: Dimensions & Weight Prima C
Prima C/ Prima CS COLPOSCOPE DIMENSIONS & WEIGHT PRIMA C DIMENSIONS & WEIGHT (Fig. 2.6) Prima C Colposcope with roller star base stand Total weight: Approx. 45 kg. (Fig. 2.6) Prima C Prima C/ Prima CS COLPOSCOPE DIMENSIONS & WEIGHT PRIMA CS DIMENSIONS &... -
Page 18: Electrical Connections Prima Cs
Prima C/ Prima CS COLPOSCOPE ELECTRICAL CONNECTIONS PRIMA CS Connect the power cable to the AC inlet socket (2) provided on the back of the swivel arm as shown in the fig.-(i). Switch on the power from on/off switch (1). - Page 19 Prima C/ Prima CS COLPOSCOPE 8.3. WIRING CODING DIAGRAM 6128000-795 Prima C/ Prima CS Issue 2.2 Printed on November,2020...
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Page 20: Electrical Connections Prima C
Prima C/ Prima CS COLPOSCOPE 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. -
Page 21: Operating Instructions Prima C
Prima C/ Prima CS COLPOSCOPE OPERATING INSTRUCTIONS PRIMA C 9.1 ON/OFF SWITCH shown as (1) in fig-2.9 is located on the upper side of the illumination box. After the appliance is swtiched on, the green illumination switch diode indicates that the microscope is ready for operation. The LED starts burning and the cooling fan starts working. -
Page 22: Control Elements Prima C/ Cs
Prima C/ Prima CS COLPOSCOPE CONTROL ELEMENTS PRIMA C 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). - Page 23 Prima C/ Prima CS COLPOSCOPE CONTROL ELEMENTS PRIMA C (continued) • Power Supply Box (9). • Knob for brightness control (10). (Fig. 2.11) Prima C/ Prima CS COLPOSCOPE CONTROL ELEMENTS PRIMA CS • Suspension arm hydraulic movement knob (11). • Magnification Knob (19).
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Page 24: Instructions For Using Microscope
Prima C/ Prima CS COLPOSCOPE 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 (2) to the required IPD by turning the lateral knob (3). -
Page 25: Changing The Magnification
Prima C/ Prima CS COLPOSCOPE INSTRUCTIONS FOR USING THE MICROSCOPE (continued) 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. -
Page 26: How To Focus The Object
Prima C/ Prima CS COLPOSCOPE INSTRUCTIONS FOR USING THE MICROSCOPE (continued) 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. -
Page 27: Red Free Image Observation
Prima C/ Prima CS COLPOSCOPE INSTRUCTIONS FOR USING THE MICROSCOPE (continued) 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. -
Page 28: Eyepieces With Diopter
Prima C/ Prima CS COLPOSCOPE INSTRUCTIONS FOR USING THE MICROSCOPE(continued) e. EYEPIECES WITH DIOPTER (Fig. 2.17) You can adjust the diopter settings as per your vision correction. • • Diopter adjustment is +/- 5D. (Fig.2.17) Prima C/ Prima CS 6128000-795 Issue 2.2... -
Page 29: Changing The Objective/ Eyepieces
Prima C/ Prima CS COLPOSCOPE CHANGING THE OBJECTIVE / EYE PIECES 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 insert able. Pull out for changing. -
Page 30: Use Of Accessories
Prima C/ Prima CS COLPOSCOPE USE OF ACCESSORIES (Fig. 2.19) 1. Install double beam splitter by replacing the binocular tube (straight or 45° 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. -
Page 31: Care And Maintenance
Prima C/ Prima CS COLPOSCOPE 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 Instrument, its safe functioning must be checked once every 12 months as per table below. We Recommended having this check performance by our service representative as part of regular Maintenance work. - Page 32 Do not use ethanol and spirit. • Do not clean products and optical components in a cleaning/disinfecting device or ultra sound bath. • LABOMED Maxi Lite coatings are fungal resistant. If you clean as described above, the coatings will not be damaged.
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Page 33: Cleaning And Disinfection
3. Alcohol is flammable,its use as a surface disinfectant should be in well-ventilated spaces only. Prima C/ Prima CS COLPOSCOPE AUTOCLAVING The rubber caps, sleeves and grips supplied by labomed are recommend for the following program for autoclaving: • Temperature: 134˚C... -
Page 34: Schedule Of Autoclavable Caps Prima C
Prima C/ Prima CS COLPOSCOPE SCHEDULE OF AUTOCLAVABLE CAPS PRIMA C Schedule of Autoclavable caps Prima C Autoclavable caps: (C1) Part no. 6122015-209 (C2) Part no. 6168000-219 (C3), (C4) Part no. 6168000-213 6128000-795 Prima C/ Prima CS Issue 2.2 Printed on November,2020... -
Page 35: Schedule Of Autoclavable Caps Prima Cs
Prima C/ Prima CS COLPOSCOPE SCHEDULE OF AUTOCLAVABLE CAPS PRIMA CS 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 6128000-795 Prima C/ Prima CS Issue 2.2... -
Page 36: Ambient Requirement
Prima C/ Prima CS COLPOSCOPE AMBIENT REQUIREMENT For Operation +10°C..+40°C Temperature Rel. humidity 30%..90% (without condensation) Air Pressure 700hPa..1,060hPa For transportation and -40°C..+70°C Temperature storage 10%..100% Rel. humidity (without condensation) Air Pressure 500hPa..1,060hPa Prima C/ Prima CS COLPOSCOPE DISPOSAL Disposal must comply with locally applicable laws & regulations... -
Page 37: Technical Specifications Prima C/ Cs
Prima C/ Prima CS COLPOSCOPE 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. - Page 38 920 Auburn Court Fremont, CA 94538 U.S.A. Phone: 510-445-1257 Fax: 510-991-9862 Email: sales@laboamerica.com www.laboamerica.com EU REP. Labomed Europe Essebaan 50 NL-2908 LK Capelle a/d IJssel The Netherlands Tel: +31 (0)10 4584222 Fax: +31 (0)10 4508251 E-mail: info@labomedeurope.com A16372 ISO 13485...