TriStar User Manual

TriStar User Manual
MODEL: STAR COLPOSCOPE
USER’S MANUAL
ZOOMSTAR™ with TRULIGHT™ COLPOSCOPE
TRISTAR™ with TRULIGHT™ COLPOSCOPE
REF: 906057T, 906057-40TU, 906140T
WALLACH® SURGICAL DEVICES
95 Corporate Drive
Trumbull, CT 06611 USA
Phone: (203) 799-2000
Fax: (203) 799-2002
www,wallachsurgical.com
EC REP
EMERGO EUROPE
Molenstraat 15
2513 BH, The Hague
The Netherlands
IMSC036-DFU • Rev. B • 10/14
Made in the USA
Table of Contents
Cautions .......................................................................................................... 3
ZoomStar™
Assembly Instructions........................................................................... 4
Operating Instructions .......................................................................... 4
Illumination ........................................................................................... 5
Focusing Instructions ........................................................................... 5
Magnification ........................................................................................ 5
ZoomStar with Trulight, USB Video ...................................................... 6
TriStar™
Assembly Instructions .......................................................................... 7
Operating Instructions ......................................................................... 7
Illumination ........................................................................................... 7
Focusing the TriStar™.......................................................................... 8
Accessories ......................................................................................... 8
Digital Camera Attachment .................................................. 8
Digital Photography ............................................................. 8
Teaching Tube .................................................................... 8
USB Video Attachment ....................................................... 9
Electrical ......................................................................................................... 11
Replacing the Fuses .................................................................................... 11
Maintenance .................................................................................................. 11
Warranty Information................................................................................... 11
Service and Repair ...................................................................................... 12
Explanation of Symbols .............................................................................. 13
Specifications
ZoomStar ™ Specifications ................................................................ 14
TriStar™ Specifications ............................................................. 14
For All Star Colposcope Models ............................................................... 15
Classification ....................................................................................... 15
Environment Conditions ...................................................................... 15
LED Light Specification ....................................................................... 15
Wallach Colposcopes EMC Compliance Information ......................... 16
Guidance and Manufacturer’s Declaration ............................................ 16
Electromagnetic Emissions ................................................................. 16
Electromagnetic Immunity ................................................................... 17
Recommended Separation Distance ....................................................... 19
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Read all safety information and instructions before using this product!
CAUTIONS:






DO NOT USE IN THE PRESENCE OF FLAMMABLE ANESTHETICS.
OBSERVE PRECAUTIONS FOR ELECTROSTATIC DISCHARGE (ESD) AND
ELECTROMAGNETIC INTERFERENCE (EMI) TO AND FROM OTHER EQUIPMENT.
LED RADIATION; DO NOT STARE DIRECTLY INTO BEAM.
DO NOT OPERATE PRODUCT IF IT APPEARS TO HAVE BEEN DROPPED OR
DAMAGED.
REMOVE AC POWER FROM ZOOMSTAR BEFORE CHECKING FOR A BLOWN FUSE.
FOR TRANSPORTATION OF THE COLPOSCOPES, PLACE COLPOSCOPE HEAD IN
LOWEST POSITION TO ASSURE STABILITY DURING TRANSPORTATION.
The Wallach family of Star colposcopes feature zoom and multi-step magnification models
mounted on a center post with an easily maneuverable 5-legged base. The upright rolling
unit is sturdy and stable.
ZoomStar™
The Wallach® ZoomStar™ colposcope features Nikon continuous zoom optics for a sharp, 3D
image for a correct magnification and field of view at all times. High power white light emitting
diodes allow the user to view images in pure white light. A green LED is used to pick up blood
vessels. The ZoomStar is mounted on a 5 point base for stability and maneuverability.
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ASSEMBLY INSTRUCTIONS
The ZoomStar™ with Trulight™ colposcope has three parts.



The Optics with eyepieces
Center Pole with the power control box
The Floor stand
1. Place the floor stand on the floor.
2. Insert the tapered end of the shaft on the bottom of the center pole into the center hole of the
floor stand. Attach the center pole to the floor stand using the tools and hardware supplied
with the floor stand.
3. Place the microscope head into the retaining ring with ocular tubes pointed upwards. Handtighten the thumbscrew. Remove protective caps from the diopter rings. Gently push the
eyepieces into the binocular tubes.
OPERATING INSTRUCTIONS
To operate the ZoomStar with Trulight colposcope:
1. Set it to the height that best suits your position via the two height adjusting controls. The
control that sets the coarse height adjustment is the large knurled hand screw on the Stand
System.
2. Raise the Optics to the desired height and then tighten the hand screw on the stand. The fine
height adjustment is the handle that protrudes at a right angle from the column. Turning this
handle will raise or lower the Optical head, but since this is a fine height adjustment, the
degree of adjustment is limited.
3. Plug the power cord into a standard 115/240 volt receptacle.
4. The master power switch (lighted green rocker switch) is located on the side panel of the
electronics box located on the pole. This switch turns the main power source ON (“I”)
or OFF (“O”).
5. The black switch on the side panel turns on the white light or the green light. The black
Illumination knob on the front panel adjusts the viewing light intensity.
6. Adjust the tilt position of the head using the tilt handle which protrudes from the side of the fine
focus rack.
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7. To lock the head tilt angle, tighten the head pitch knob snugly, but do not over tighten. Loosen
the knob to release angle position.
8. For transportation of the colposcope, place the colposcope head in the lowest position to
assure stability during transportation.
ILLUMINATION
a. LED Light Frequency
b. Dominant Wave Length for Green Light Emitting Diode
Minimum value 530 nm (nanometers)
Maximum value 535 nm (nanometers)
FOCUSING INSTRUCTIONS
1. Place microscope optics into the mounting ring on scope; hand tighten the set screws.
2. Remove protective “Nikon” caps from diopter rings.
3. Slide in eyepieces.
4. Turn on the white light.
5. Turn both diopter rings on the binocular tubes until the end surface of each
ring coincides with the black engraved lines.
6. Looking into the eyepieces, adjust the interpupillary distance by moving the binocular tubes so
that both circular view fields are brought into coincidence.
7. Set the zoom knob to 3x. (If power zoom is available, the footswitch should be used.)
8. Position microscope head at a starting point approximately 12” from the target. Rotate the fine
focus knobs to bring the target into focus. The fine focus knobs can be tightened or loosened
to adjust travel ease by rotating them in opposite directions. Do not re-adjust fine focus after a
clear image is viewed at the 3x zoom magnification.
9. Rotate the zoom knob to 0.7x.
10. Close your right eye; adjust the left diopter ring to bring the target into fine focus. Close your
left eye; adjust the right diopter to bring the target into fine focus.
11. At this point, focusing has been completed. Steps 6 - 9 can be repeated to check for exact
focusing if desired. As long as the scope is not moved out of position, or the fine adjustment is
not moved, the target will keep its sharpness all the time regardless of the zoom magnification
level.
MAGNIFICATION
Final magnification is determined by multiplying the eyepiece power times the microscope body
power times the objective lens power. The Wallach ZoomStar with Trulight is normally shipped
with 20x eyepieces and a 1/3 objective lens. Therefore, at the lowest setting of the magnification
power knob on the microscope body (0.7), the final magnification would be:
20 x 0.7 x 1/3 = 4.6x power
At the highest setting of the magnification power knob (3.0) the final magnification would be:
20 x 3.0 x 1/3 = 20.0x power
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ZOOMSTAR WITH TRULIGHT, USB VIDEO
Sentech USB Camera Setup
1. Install Sentech Image Viewing Software (StCamSWare) onto laptop desktop. (see Quick Start
Guide IMSC031)
2. Attach Video ZoomStar microscope head to laptop via USB cable provided.
3. Turn on Colposcope.
4. Double click on the “STCamSWare” icon on the desktop.
5. Using the cursor, choose “Options,” then “Settings”. A window will open at the bottom right of
screen.
6. Check the “Auto” boxes next to the Gain and Shutter features.
7. Click on the “Save” button, and then choose “Yes”.
8. Focus to get the desired image on the screen.
9. To capture the image on the screen, choose “Capture” and then “Snap Shot”.
10. A window will open to the right of the main image.
11. To save the image, click to “select” the image with your left mouse button. This will
cause a “blue” border to appear around the image of interest.
12. With the mouse over the image, click using the right mouse button and a menu will appear.
Select “Save”.
13. The image may be saved in one of four formats: Bitmap, TIFF, JPEG or PNG.
14. Complete the information as you would for any software program and save to a location of
your choice.
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TriStar™
The TriStar™ with Trulight™ Colposcope is a highly versatile triple magnification stereoscopic
colposcope. A magnification of 8x, 13x and 21x is obtained with the 3-step magnification changer.
The field of view diameters are 24mm, 15mm and 9mm. A vessel delineation filter is incorporated
to provide clear visualization of vascular patterns. The optical beamsplitter permits the attachment
of a co-observation teaching tube and photographic accessories for documentation purposes,
thereby extending the capability of this instrument from routine gynecologic examination to
gynecologic research. The image obtained through the accessory ports is identical to that viewed
through the binocular tubes via the optical beamsplitter. Photographic documentation capabilities
include video and digital photography.
High power white light emitting diodes allow the user to view images in pure white light. A green
LED is used to pick up blood vessels. The TriStar mounts on a 5 point base for stability and
maneuverability.
ASSEMBLY INSTRUCTIONS
The TriStar has two parts. The following are easy assembly instructions for the new colposcope:
1. Identify the two parts
a. The optical head with eyepieces on the center pole with control box
b. The Floorstand
2. Place the Floorstand on the floor.
3. Insert the tapered end of the shaft on the bottom of the center pole into the
center hole of the Floorstand. Attach the center pole to the Floorstand by
inserting the large screw into the bottom of the stand. Tools and hardware
are supplied with the Floorstand.
OPERATING INSTRUCTIONS
1. Set the colposcope to the height that best suits your situation via the two height adjusting
controls. The control that sets the coarse height adjustment is the large knurled hand ring on
the Stand System. Raise the Optical System to the desired height and then tighten the hand
screw on the Stand. The fine height adjustment is the handle that protrudes at a right angle
from the column. Turning this handle will raise and lower the Optical System, but since this is
the fine height adjustment, it will only raise the height a limited distance.
2. Plug the cord into a standard wall outlet.
3. The master power switch is located on the side panel of the control box assembly. This switch
turns the main power source “ON” or “OFF”.
4. The light switch on the side panel turns the light to “white” or “green”. The light intensity is
adjusted by the knob on the front of the control box.
ILLUMINATION
c.
LED Light Frequency
d. Dominant Wave Length for Green Light Emitting Diode
Minimum value 530 nm (nanometers)
Maximum value 535 nm (nanometers)
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FOCUSING THE TRISTAR
1. Set the binocular eyepieces to “0” and adjust them to the proper interpupillary distance.
2. Peering through the eyepieces, move the entire TriStar backwards or forwards to get a “rough”
focus on the target. (12” or 300mm from objective lens to target.)
3. Set the fine focus by rotating the fine focus adjust lever (the same lever as the tilt adjust) until
the rack is at the midpoint.
4. Focus at the highest magnification. Focusing at this magnification is extremely critical and
leads to perfect focusing for all other magnification levels. Thereafter, the physician only has
to switch to another magnification without the need to refocus the instrument. If the instrument
is repositioned, however, the procedure must be repeated.
5. To set the image of the target in each eye, turn the eyepieces themselves. (Notice that the
eyepieces are calibrated to help refocus the eyepiece setting next time.)
6. Focusing is complete.
ACCESSORIES
Your TriStar split beam colposcope is designed to provide the ultimate ease in colposcopic digital
photography. The complete system of photographic equipment for digital pictures has been
created to allow even the novice photographer to clearly document visual observations for patient
files.
No special techniques are required and there is no need to remove the camera when photography
is not intended. Camera focusing is achieved through the TriStar oculars.
Digital Camera Attachment
1. Remove camera lens cover. Attach the adaptor mounting ring to the camera by aligning the
red mark on the ring with the red dot on the camera lens mount. Then turn the ring until a click
is heard when the attachment is secured.
2. Remove the black cap on the digital camera photo adaptor by loosening the stainless steel set screw.
Place the end of the adaptor mounting ring into the photo adaptor and retighten the set screw.
3. Attach the digital camera photo adaptor to the colposcope accessory port. The camera may be
mounted on either the right or the left accessory port.
4. Remove the protective accessory port cap. Guide slots on the photo adaptor permit the
positioning of the camera. Align the slots in the photo adaptor with the guides on the adaptor
ring. Slide the adaptor ring over the photo adaptor and tighten gently in a counterclockwise
direction. DO NOT OVER TIGHTEN
5. The camera is now ready for use.
Digital Photography
Refer to instruction manual for digital camera.
Looking through the oculars, adjust the instrument for focus and composition. When the desired
image is obtained, press the shutter release button on the camera to make the exposure.
Teaching Tube
For teaching or co-observation the teaching tube provides a second party viewing head as an
optional accessory.
The teaching tube may be mounted on either the right or the left accessory port provided on the
beamsplitter. Remove the protective accessory port cap. Guide slots on the teaching tube allow
for positioning of the unit. Align the slots on the teaching tube with the guides on the adaptor ring.
Slide the adaptor ring over the teaching tube and tighten gently in a counterclockwise direction.
DO NOT OVER TIGHTEN.
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USB Video Attachment
There is a video camera C-Mount Adaptor available to attach any analog or USB
camera. (Please note that only one side of the C-Mount Adaptor can attach to the TriStar.)
The instructions are as follows:
1. Attach the mounting ring to the camera.
2. Attach the entire camera to the C-mount Adaptor.
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3. Then attach the C-Mount Adaptor to the TriStar.
4. Plug in the S video cable if you have an analog camera. Next, plug in the power supply.
Then plug the power supply into the wall. For a USB camera, plug the USB cable into the
camera and the other end into the US port on the laptop or PC.
5. After the C Mount has been attached to the colposcope, the camera needs to be oriented
so that the image on the monitor is the same as that viewed through the optical head. On
the C mount, loosen the large silver knurled ring. Rotate the camera head until the image
on the monitor is the same as what is viewed through the optical head. Once it is aligned
properly, rotate the knurled ring clockwise until it is locked in a snug position.
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Electrical
The Wallach Colposcope with Trulight requires a 100-240V ~50-60 Hz power source to
operate. It is supplied through a 2.5 meter medical grade detachable cord. For your safety,
assure that your electrical outlets meet code regulations.
Replacing the Fuses
1. Shut OFF (labeled “O”) the master switch and unplug the power cord.
2. The electronics box contains two fuses beneath the power socket.
3. To remove, pull out the drawer beneath the power socket.
4. Remove the blown fuse from the holder and replace with a 2 amp, 5mm x 20mm Fast Blow
Fuse (Part Number 109645).
5. Push the fuse holder back into the electronics box.
Maintenance
PRECAUTION: DO NOT IMMERSE EQUIPMENT COMPONENTS IN LIQUID; UNPLUG
BEFORE CLEANING; DRY BEFORE USE.
Clean the lenses and protective light covers with silicone-treated lens tissue paper ONLY.
The colposcope finish is a high-gloss enamel and may be wiped down with disinfectant. Keep the
instrument clean and dust-free. When the colposcope is not in use, replace protective covers.
Warranty Information
The Wallach Star series of colposcopes is supported by a seven-year warranty from date of
purchase covering any failure of the device due to defective workmanship or components, when
used in compliance with the product’s intended use.
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Service and Repair
Only Wallach Surgical Devices is authorized to service or repair this unit. If repair is attempted
outside the factory, the warranty will be considered void. Wallach Surgical Devices is not
responsible for any injury resulting from repairs made by other individuals or organizations not
certified by Wallach Surgical Devices.
In the event your Colposcope with Trulight becomes inoperative, please make the following checks
before calling the factory.
1. Check that the unit is plugged into a working wall receptacle.
2. Check for a blown fuse (if fuse needs to be replaced see directions)
If your Colposcope with Trulight is still inoperative, remove the unit from use and contact our
qualified factory service personnel at (866) 928-3211.
If a repair is needed, equipment must be sanitized and carefully packaged in a protective carton for
return to the factory. All shipments must be made via pre-paid parcel post or U.S. Mail. COD
packages will not be accepted. It is not necessary to ship the base unless there is a problem with it.
Return carton to:
Attention: Repair Department
95 Corporate Drive
Trumbull, CT 06611 USA
Phone: (203) 799-2000
Fax: (203) 799-2002
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Explanation of Symbols
Reorder number
Serial number
Consult instructions for use
Caution
U.S. Federal law restricts this device
to sale by or on the order of a physician.
For professional use only
Product conforms to the Medical Device
Directive 93/42/EEC
Authorized Representative in the
European Community.
Manufacturer
AC Main Power OFF
AC Main Power ON
Shock Hazard
Pinch Point
In order to preserve, protect and improve the quality of the
environment, protect human health and utilize natural
resources prudently and rationally—do not dispose of waste
electrical or electronic equipment (WEEE) as unsorted
municipal waste. Contact local WEEE disposal sites.
®
Wallach is a registered trademark of CooperSurgical, Inc.
Zoomstar™,Tristar™ and TrueLight™ are trademarks of CooperSurgical, Inc.
®
Nikon is a registered trademark of Nikon Corporation in the United States and certain other countries.
STCamSWare is a product of Sentech America, Inc.
© 2014 CooperSurgical, Inc.
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Specifications
ZOOMSTAR™ SPECIFICATIONS








Nikon Continuous Zoom Optics 4.5x to 20x
Maximum height 51”; minimum height 40”
Overall weight 23 ½ lbs.
Center of column to end of leg 12”
Height of microscope to floor 36” to 46”
8 ½ foot grounded power cord
Fused power input lamp 2.0 amp, two fuses, 2 amp 5mm x 20mm Fast Blow Fuses
100-120V/200-240V AC, 50/60 Hz, 100VA
TRISTAR™ SPECIFICATIONS
Type
Warranty
Power Requirements
Mounting System
3-Step Magnification with beamsplitter
7 Years
100-120V/200-240V AC, 50/60Hz, 100VA
5-Leg Rolling Base
Standard Optical Configurations
Objective Lens (working Distance)
Total Magnification
Field of View
Depth of Field
Ocular (Eyepieces)
Diopter Adjustment
Interpupillary Range
Tilt of Viewing Head
Binocular Tube Design
Binocular Tube Length
Magnification Changer Factor
Vessel Delineation Filter
300mm
8x, 13x, & 21x
8.5x=23.4mm, 13.6x=14.6mm, 21.3x=9.4mm
8x=3.1mm, 13.6x=1.2mm, 21.3x=0.9mm
16x Highpoint, with locking diopters
Independent adjustment with position locking –6/+4
54mm to 80mm
59 degrees
Straight
160mm
1.0x, 1.6x, 2.5x
Yes
Illumination System
Light Emitting Diodes (LED) (5000/7000 degrees Kelvin)
Green LED for blood vessel delineation.
Illumination
Photographic Capabilities
Digital, Video
Yes
Options
Teaching Tube
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For All Star Colposcope Models
CLASSIFICATION
Model
Star with Trulight Colposcopes
Safety Class
I
ALL models of Colposcopes have no Applied Parts.
Do not get fluid into the Colposcope. Should any liquid or solid object fall into the unit,
unplug the unit and call Technical Support (866) 928-3211.
 The LED Model Colposcopes are suitable for continuous operation.
 The LED Model Colposcopes are classified as normal equipment (IPX0) according to
protection against ingress of water.


ENVIRONMENT CONDITIONS
Use
Environmental Temperature:
Relative Humidity:
Air Pressure:
between +10 °C and +40 °C
between 10% and 90%
between 700 hPa and 1060 hPa
Shipping and Storage:
Environmental Temperature:
Relative Humidity:
Air Pressure:
between +10 °C and +40 °C
between 10% and 90%
between 700 hPa and 1060 hPa
LED LIGHT SPECIFICATION
White LED:
Correlated Color Temperature
Rendering Index
Radiometric Power
Total Irradiance
Lifetime [max. drive I=1000mA]
Green LED:
Average Wavelength
Radiometric Power
Total Irradiance
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3000-3200K
90 min
80 mW
Less than 1 W/m2 at max intensity
Min. 25,000 hours
520-535 nM
80 mW
Less than 1 W/m2 at max intensity
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Wallach Colposcopes EMC Compliance Information

MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and
needs to be installed and put into service according to the EMC information provided in
the ACCOMPANYING DOCUMENTS.

Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL
EQUIPMENT.
Guidance and Manufacturer’s Declaration – Electromagnetic
Emissions
The Wallach Colposcope is intended for use in the electromagnet environment specified below.
The customer or the end user of the Wallach Colposcope should assure that it is used in such an
environment.
Emissions Test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
Flicker emissions
Compliance
Group 1
Class A
Electromagnetic Enviroment- Guidance
Wallach Colposcopes use RF energy only for it internal function.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
Wallach Colposcopes are suitable for use in all establishments,
including domestic establishments and those directly connected
to the public low-voltage power supply network that supplies
buildings used for domestic purposes.
Class A
Complies
IEC 61000-3-3
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Guidance and Manufacturer’s Declaration – Electromagnetic
Immunity
The Wallach Colposcopes are intended for use in the electromagnet environment specified below.
The customer or the end user of the Wallach Colposcopes should assure that it is used in such an
environment.
Immunity Test
Electromagnetic
discharge (ESD)
IEC 60601
Test Level
Compliance
Level
Electromagnetic Environmental –
Guidance
+6 kV contact
+6 kV contact
+8 kV air
+8 kV air
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30%.
Electrical fast
transient/burst
+2 kV for power
supply lines
+2 kV for power
supply lines
Mains power quality should be that of a
typical commercial or hospital environment.
IEC 61000-4-4
+1 kV for
input/output lines
+1 kV for
input/output lines
Surge
+1 kV differential
mode
+1 kV differential
mode
+2 kV common
mode
+2 kV common
mode
<5 % UT
(>95 % dip in UT)
for 0.5 cycle
<5 % UT
(>95 % dip in UT)
for 0.5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
<5 % UT
(>95 % dip in UT)
for 5 sec
3 A/m
3 A/m
IEC 61000-4-2
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
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.
If the user of the Wallach Colposcope
requires continued operation during power
mains interruptions, it is recommended that
the Wallach Colposcope be powered from
an uninterruptible power supply or a battery.
Power frequency magnetic fields should be
at levels characteristic of a typical location in
a typical commercial or hospital
environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level. In this case 230 V.
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Guidance and Manufacturer’s Declaration – Electromagnetic Immunity (continued)
Immunity Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic Environmental Guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the Wallach Colposcope, including
cables , than the recommended separation
distance calculated from the equation
applicable to the frequency of the transmitter.
Conducted RF
3 Vrms
IEC 61000-4-6
150 kHz to 80 MHz
Radiated RF
3 V/m
IEC 61000-4-3
80 MHz to 2.5 GHz
Recommended separation distance
 3.5 
d   P
 V1 
3V
 3.5 
d    P 80 MHz to 800 MHz
 E1 
3 V/m
7
d    P 800 MHz to 2.5 GHz
 E1 
where P is the maximum 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,a should be less than the compliance
level in each frequency range.b
Interference may occur in the vicinity of
equipment marked with the following symbol:
a
b
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 with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the Wallach Colposcopes
are used exceeds the applicable RF compliance level above, the Wallach Colposcope should
be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the Wallach Colposcope.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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Recommended Separation Distance
This section discusses the Recommended Separation Distance between portable and mobile RF
communications equipment and the Wallach Colposcopes.
The Wallach Colposcopes are intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the Wallach Colposcopes
can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the Wallach Colposcopes
as recommended below, according to the maximum output power of the communications
equipment.
Separation distance according to frequency of transmitter
Rated maximum output
power of transmitter
Watts
0.01
0.1
1
10
100
Meters
150 kHz to 80 MHz
80 MHz to 800 MHz
 3.5 
d   P
 v1 
 3.5 
d   P
 E1 
0.1167
0.3689
1.1667
3.6894
11.667
0.1167
0.3689
1.1667
3.6894
11.667
800 MHz to 2.5
GHz
7
d  P
 E1 
0.2333
0.7379
2.3333
7.3789
23.333
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 rating of the transmitter in watts (W) according to the transmitter manufacturer.
For the Wallach Colposcopes
v1 = 3 Vrms
E1 = 3 V/m
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.
IMSC036-DFU • Rev. B • 10/14
19
Made in the USA
SURGICAL DEVICES
95 Corporate Drive
Trumbull, CT 06611 USA
Phone: (203) 799-2000
Fax: (203) 799-2002
www.wallachsurgical.com
IMSC036-DFU • Rev. B • 10/14
Wallach Surgical Devices
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