colposcope model 935 led - Booth Medical Equipment

colposcope model 935 led - Booth Medical Equipment
COLPOSCOPE
MODEL 935 LED
OWNER’S MANUAL
PRECISION MICROSCOPES
Register your product warranty online:
http://www.seilermicro.com/warranty-registration/
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TABLE OF CONTENTS
INDICATIONS FOR USE
PRESENTATION AND USE
COLPOSCOPE FLOOR STAND
THE COLPOSCOPE HEAD
CLEANING
HOW TO FOCUS THE COLPOSCOPE
OPTICAL AND FIELD MAGNIFICATION TABLE
TECHNICAL DATA
LED LIGHTSOURCE
OWNER’S RECORD
NOTES
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4
4
5
5
6
7
7
8
14
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INDICATIONS FOR USE
The Seiler Colposcope is intended to provide magnified visualization of the tissues of the vulva, vagina, cervix, and anogenital area. It is used to evaluate these tissues, select areas for biopsy, as necessary, and to facilitate related procedures, e.g., LEEP, conization, etc.
Caution: Federal law restricts this device to sale by or on the order of a physician or practitioner trained in its use.
PRESENTATION AND USE
The sections contained in this Manual were especially grouped to serve the owners of the COLPOSCOPE MODEL 935
from Seiler Precision Microscopes.
Read this Manual before setting up the equipment, in order to avoid damage from improper usage.
For safe use of the colposcope, it is necessary to be familiar with the details of its operation prior to use.
Therefore, it is advisable that personnel operating the colposcope read this manual prior to using the equipment.
COLPOSCOPE FLOOR STAND
NOMENCLATURE OF THE NUMBERED PARTS
1
2
3
4
1) Colposcope Head
2) Head securing knob (Caution: Optics will drop when knob is loosened.)
3) Column height adjusting knob
4) LED Illuminator
5) Base with casters
A knob located at the stand tube (item 3) fixes the vertical movement of
the ­column.
By turning the knob (item 3) counterclockwise or clockwise, the system
can be released or fixed, and the height of the column be adjusted to
achieve the correct height for the patient examination.
5
4
THE COLPOSCOPE HEAD
OPTIC POD COMPONENTS
Eyepieces
Binocular Head
Thumb Screw
Magnification Turret
Tension Adjustment Knob
Objective Lens
Handle
Fine Focus Knob
Green Filter (Push/Pull Knob)
CLEANING
The Objective, at the bottom of the Colposcope body, may be exposed to blood and other bodily fluids. Spots on the objective
dim the passage of light.
Alcohol or warm water in a mild detergent, applied with a clean cotton swab can be used to remove all smudges. Apply with
soft and CIRCULAR movements. Follow your laboratory’s procedures to remove bloodstains or other ­contaminants from your
equipment.
If the objective is too blotched, change to another cotton swab for each circular movement to avoid spreading the impurities
again.
The Objective lens can be protected by use of the Sterilizable Protector Cap. It is fitted on the external diameter of the objective lens and protects it against mechanical damage and against contamination. (catalog #6132000)
Clean the metallic parts (chrome-plated or painted) with cotton, alcohol or mild detergent.
Lubrication
It is recommended to lubricate the Colposcope head after 5 years of use.
5
HOW TO FOCUS THE COLPOSCOPE
Preliminarily:
Displace the Articulated Arm of the stand set where the colposcope is fixed, and point its objective to the direction of the field
to be observed. Note that the objective, at front of the Colposcope, be positioned at a distance equal the focus engraved in
millimeters on the ­external face of the objective. Example: With a 300mm objective, keep a distance of about 300mm between
the objective and the specimen.
Focus the observation field
Interpupillary distance adjustment:: Look through the two eyepieces with both eyes open and adjust the interpupillary distance
as explained below in the items “inclined ­binoculars” and “straight ­binoculars”, until they are juxtaposed to the two pupils and
the vision of the field appears as only one image.
With the inclined binoculars grasp each tube of the of the binoculars and move the tubes in or out, so that, as it was already
said, the eyepieces are j­uxtaposed to the observer’s pupils.
With the straight binoculars the action of separation or approach is made in a soft and semi-rotation movement, in both of the
prism boxes.
You should now, using both eyes, see one clear stereoscopic image.
Parfocalizing Procedure:
1) Set both eyepieces at zero (0).
2) Turn the magnification drum to the highest setting and focus sharply on a target, such as a piece of paper with an “X”
drawn on it, by using the focusing knobs.
3) Then turn the magnification drum to the lowest setting (1) and focus by turning the eyepieces clockwise or counter clockwise until you reach sharp focus.
4) Once the image is clear in both eyes, the Parfocalizing Process is complete.
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OPTICAL AND FIELD MAGNIFICATION TABLE
The optical magnifications achieved with the Colposcope are determined by 3 variables: the objective focal distance,
the position of the Magnification Selector, and by the eyepiece used.
The table shows the optical magnification and the observed field diameters, in millimeters, depending on those variables. At the bottom line of the table the illuminated field is shown, corresponding to the light disk incident on the
field, with a diameter that depends only on the focus of the work objective.
The magnification selector has 3 positions: 1, 2, and 3. The 2nd position is repeated in the selector. The working position is the one aligned to the black dot mark.
MAGNIFICATION TABLE FOR 935.
BINOCULAR HEAD FOCAL LENGTH =
170
OBJECTIVE LENSES
EYEPIECE
10x/18
12.5x/16
16x/16
20x/12
175
POSITION OF
MGNIFICATION
BUTTON
200
FIELD
MGNIFICATION
250
FIELD
MGNIFICATION
300
FIELD
MGNIFICATION
400
FIELD
MGNIFICATION
FIELD
1(0.6)
5.83
30.88
5.10
35.29
4.08
44.12
3.40
52.94
2.55
70.59
2(1.0)
9.71
18.53
8.50
21.18
6.80
26.47
5.67
31.76
4.25
42.35
3(1.6)
15.54
11.58
13.60
13.24
10.88
16.54
9.07
19.85
6.80
26.47
1(0.6)
7.29
27.45
6.38
31.37
5.10
39.22
4.25
47.06
3.19
62.75
2(1.0)
12.14
16.47
10.63
18.82
8.50
23.53
7.08
28.24
5.31
37.65
3(1.6)
19.43
10.29
17.00
11.76
13.60
14.71
11.33
17.65
8.50
23.53
1(0.6)
9.33
27.45
8.16
31.37
6.53
39.22
5.44
47.06
4.08
62.75
2(1.0)
15.54
16.47
13.60
18.82
10.88
23.53
9.07
28.24
6.80
37.65
3(1.6)
24.87
10.29
21.76
11.76
17.41
14.71
14.51
17.65
10.88
23.53
2(0.6)
11.66
20.59
10.20
23.53
8.16
29.41
6.80
35.29
5.10
47.06
3(1.0)
19.43
12.35
17.00
14.12
13.60
17.65
11.33
21.18
8.50
28.24
4(1.6)
31.09
7.72
27.20
8.82
21.76
11.03
18.13
13.24
13.60
17.65
illuminated field
65
72
90
108
144
TECHNICAL DATA
A - Colposcope Head
MicroscopeGalilean System
Binoculars
Straight, F=170mm (optional: Inclined, F=135)
Objective300mm (optional: 200-400mm)
Eyepieces
WF 12.5x (optional: 10x/18x)
MagnificationRefer to Table
Interpupillary Distance
Adjustable between 42mm & 75mm
Illumination LED Illumination Sytem
(Optional: Halogen 15V/150W or Metal Halide)
Light Conductor
Liquid Light Guide
FilterGreen
FocusingFine Focus: 11mm
B - Colposcope Stand
Angular Rotation
360 Degrees
Distance between the 1016mm-1193mm
floor and the objective
Base
Five casters, two with brakes
Total Weight18.14 kg
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LED LIGHTSOURCE
1. INTRODUCTION
Congratulations on the purchase of your new SSL-2000 Light Source! This user-friendly LED light source is a high
efficiency light source utilizing state of-the-art superior illumination technology. It offers a variety of features such as:
• 6500º K daylight brightness for good color definition
• Quiet operation
• Long life, 50,000 hrs.
• Compact and light weight
• Pulse-width Modulation (PWM) Electrical Dimming
This section of the manual will help you to install the device and optimally integrate it with other components of
your system. It will also instruct you how to operate the LED Light Source and how to keep it clean. It will give you
maintenance and service guidelines as well as recommendations for best performance results.
1.1 INDICATIONS FOR USE: The LED Light Source is used to illuminate the site of surgery during minimally invasive
surgical procedures. The light is transmitted from the light source through a fiber optic cable and a scope.
2. WARNINGS
To prevent fire or electric shock, do not open or expose the LED light source unit to rain or moisture. Refer all servicing to
qualified personnel only.
Not suitable for use in presence of flammable anesthetic mixture with air or with oxygen or nitrate oxide.
To prevent any potential electro-magnetic interference, do not use any kind of cellular phone near the
light source.
This product should be used only with type BF endoscopic instruments which have been certified
according to IEC 601-1 for medical equipment and IEC 601-2-18 for endoscopic equipment.
Caution: This product is not provided as sterile.
Caution: All devices connecting to the LED Light Source must be classified as medical equipment. When
additional information processing equipment is connected to the LED Light Source, the operator must
determine that all equipment complies with the appropriate end-product standards (such as IEC 60950
or IEC 60065 and the Standard for Medical System, IEC 60601-1-1).
Caution: The LED Light source can cause permanent eye damage if viewed directly with unprotected eye.
To reduce the chance of eye damage, set the intensity control always to the minimum level and plug the
fiber optic cable into the unit before turning on the power.
EQUIPMENT CONNECTION
Caution: The fiber optic cable must be a NON-CONDUCTIVE CABLE. It should not have conductive
shielding or any other conductive connection between the patient and equipment. Such connection will
impair safety of the equipment. It must be rinsed free of soaking/disinfectant solution and dried before
plugging into the LED light source receptacle. Ensure the optical surface is clean before engaging into the
light source.
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3. SPECIFICATIONS
Item
Light Source Type
Power
Color Temperature
Specification
LED (Light Emitting Diode)
50 Watt
Led life
Light guide adapter
50,000 hours (typical)
Brightness control
Input voltage
Rated Power
Regulatory Approvals
PWM (Pulse-width Modulation) – 0-100% Dimming
100-240V AC, 50/60 Hz
52 watt
UL60601-1,CAN/CSA C22.2 No.601.1 (SUP1+AM2),EN 60601-1-2 and CE
marked
Class I, BF-type
Continuous operation
Not Protected Equipment, IPX0
6500º K
Equipment Class
Mode of Operation
Water Resistant
Operating Environment
Temperature
Relative Humidity
Air Pressure
Storage Environment
Temperature
Relative Humidity
Air Pressure
Dimensions
Weight
+0° to +40° C (32° to 104° F)
0 to 85%rh, non condensing
700 to 1060 hPa
-20° to +60° C (-4° to 140° F)
30 to 95%rh, non condensing
700 to 1060 hPa
4.65” W x 3.32” H x 7.25” D
2.5 lbs./1.14 kg
4. OPERATING ELEMENTS, SYMBOLS AND FUNCTIONS
4.1 FRONT PANEL
2
1
3
No.
1
2
3
Name
Power switch
Light Guide Adapter
Intensity Control
Function
Turns the light source on and off. Fan will operate
Electronically controls the light output
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4.2 REAR PANEL
2
3
4
1
Figure 2. LED Light Source Rear Panel
No.
1
2
3
4
Name
AC main inlet
Fuse
Grounding Connector
Venting grids
Function
Accepts AC power cord
2A, 250V (1/4” x 1 ¼”) time delay
For potential equalization
Allows adequate ventilation and cooling of the light source
4.3 Bottom Panel
Figure 3. LED Light Source Product Label
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5. INSTALLATION
5.1 SETTING UP THE LED LIGHT SOURCE
Place the LED light source on a stable surface (cart, counter, stand, etc.).
NOTE: Avoid places where the light source may be splashed with liquid.
Absolutely DO NOT use in any environment with explosive or flammable gases.
DO NOT block the venting grids of the LED light source.
Make sure the power switch is in OFF position.
Connect AC power cord to the power inlet located on the rear panel of the light source.
CAUTION: Use only cords provided with the light source.
Plug the AC power cord into a wall outlet using the three-prong plug supplied with the unit.
CAUTION: To prevent electric shock, connect power cords of peripheral equipment through medical isolation
transformers.
NOTE: When using medical isolation transformer, be sure to check the transformer power ratings.
Make sure that the power cord is connected to the main power with three-prong plug (USA use UL2601-1 rated
isolation transformers and/or power strips only).
CAUTION: When used in clinical or residential areas near radio or TV units, this equipment may be subjected to radio
interference. To avoid adverse electromagnetic effects, DO NOT operate this equipment near RF energy equipment.
5.2 CONNECTING THE FIBER OPTIC CABLE
Turn intensity control to the minimum setting. Connect the light cable to the instrument and then plug the light cable
endfitting into the port on the front panel.
6. OPERATION
6.1 POWERING UP THE LED LIGHT SOURCE
To operate the LED light source: Turn on the power switch. The indicator on power switch will light.
6.2 LIGHT BRIGHTNESS DISPLAY AND CONTROL
The light brightness adjustment enables the user to obtain a brighter or darker illumination of the object of observation.
Adjust the light intensity by turning the intensity control knob.
7. CLEANING
NOTE: Always disconnect the power cord before cleaning the system.
The unit can be cleaned with any cleaning agent, which is used for external cleaning of electric equipment, according to
instructions given by the manufacturer of the cleaning solution.
Do not allow excessive moisture or liquids to come in direct contact with the unit.
Do not use cleaning agents that are not permitted for use with plastics, i.e., ammonia, acetone, salty acids (HCl), etc.
Do not allow cleaning agents or liquids to enter the unit outlets.
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8. DISINFECTION
8.1 DISINFECTING THE UNIT
NOTE: Always disconnect the power cord before cleaning the system.
Use any disinfectant agents which are commonly applied while disinfecting surfaces of electric medical equipment. Such
disinfectant agents are usually in the form of sprays or damp cloths.
Follow the instructions given by the manufacturer of the disinfectant solution.
9. SERVICING AND REPAIR
Defective items of equipment are to be serviced and repaired exclusively by persons authorized by the manufacturer. All
repair work shall employ original manufacturer’s parts only.
9.1 FUSE REPLACEMENT
CAUTION: Always disconnect power cord and turn main switch off before fuse replacement.
Turn light source off and unplug power cord. On back of unit remove fuse by turning fuse cover and pulling out fuse.
Replace fuse with 2 AMP (1/4” x 1 ¼”) time delay 250V rated fuse. Insert back into fuse housing.
Re-connect the power cord and turn the LED light source on according to section 6.1.
9.2 LIMITED WARRANTY
Your LED light source carries a 1-year warranty from the date of shipment on workmanship and all defects of material, excluding replaceable sweatbands, headband, fiberoptic cable and lamps. Should your product prove to have such
defects within one year of the shipment. Seiler Instrument will repair or replace the product or component part without
charge. Should your LED Light Source product(s) need servicing under this warranty, please contact, Seiler Instrument
return authorization documentation. You should carefully pack unit in a sturdy carton and ship it to the factory. Please
include a note describing the defects, your name, telephone number and a return address. Warranty does not cover
equipment subject to misuse, accidental damage, normal wear and tear or if transferred to a new owner without authorization from Seiler Instrument. This warranty gives you specific legal rights and you may also have other rights that vary
from state to state.
POST WARRANTY REPAIRS: You may return your product(s) for repair, shipping prepaid to the factory. Your product will
be inspected and an estimate of repair charges will be submitted to you for approval. Payment must be received before
repairs are completed.
• In the US: 800-489-2282 (toll free)
• FAX number: 314-968-3601
• Customer Service: 314-218-6336
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10. END OF PRODUCT LIFE
We encourage our customers to recycle this product whenever possible. Disposal of this unit must be performed in accordance with the applicable local environmental regulations.
In the United States a list of recyclers in your area can be found at: http:/www.eiae.org/.
Please contact customer service to issue a return authorization to return product to manufacturer at the end of product
life.
11. TROUBLESHOOTING
Problem
The power indicator (refer to 4.1)
is not lit.
The power indicator is lit, but the
lamp will not ignite.
Solution
A. Check that the AC power cord is properly connected.
B. Check the unit fuses. If necessary, replace.
Turn intensity control know clockwise to increase light output intensity.
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OWNER’S RECORD
Model Number
Serial Number
Date Purchased
Location Purchased
NOTES
14
PRECISION MICROSCOPES
We are here to serve you!
If you have any questions regarding Seiler’s products or services,
please feel free to contact us.
Toll-Free: 800.489.2282
Local: 314.968.2282
Fax: 314.968.3601
E-mail: [email protected]
www.seilerinst.com
• Microscope Division Manager
Dane Carlson
ext. 365 • [email protected]
• Corporate Marketing/Sales Representative
Nicole Rasch
ext. 345 • [email protected]
• Technical Product Information
Tony Leise
ext. 363 • [email protected]
• Bulb Order Information
Sandra Jeremich
ext. 336 • [email protected]
15
PRECISION MICROSCOPES
3433 Tree Court Industrial Blvd.
St. Louis, Missouri 63122
Toll Free: (800) 489-2282
Local: (314) 968-2282
Email: [email protected]
Web: www.seilerinst.com
Version 09/22/14
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