000_L-IE-5152E_CF-1.book Page 1 Monday, July 29, 2013 10:30 AM
Digital Retinal Camera
CF-1
Operation Manual
Make sure you read this manual before using the instrument.
Keep this manual in a safe place so that you can use it in the future.
000_L-IE-5152E_CF-1.book Page 2 Monday, July 29, 2013 10:30 AM
PLEASE NOTE
1. Please contact your sales representative or local Canon dealer to have the instruments installed.
2. The computer and monitor used in the CF-1 fundus imaging system must conform to IEC60601-1/
UL60601-1 or IEC60950/UL60950.
Furthermore, all configurations shall comply with the system standard IEC 60601-1-1. If in doubt, consult
your sales representative or local Canon dealer.
Be sure to also use an isolation transformer conforming to IEC60601-1/UL60601-1 when a computer or
monitor conforming to IEC60950/UL60950 is used.
3. The user is responsible for the use and maintenance of the product.
We suggest that a dedicated individual is assigned responsibility for maintenance to ensure that the product
is kept in good condition and can be used safely.
Medical products must be used only by a doctor or a legally qualified person.
4. This product may malfunction due to electromagnetic waves caused by cellular phones, transceivers, radio-
controlled toys, etc. Be sure to avoid having objects such as these, which affect this product, brought near
the product.
5. In no event will Canon be liable for direct or indirect consequential damage arising out of the use of this
product. Canon will not be liable for loss of image data for any reason.
6. Reading of images and storage of data must be performed in accordance with the law of the country where
the product is being used. Also, the user is responsible for maintaining the privacy of image data.
7. The power cable supplied is designed to be used solely with this camera. Do not use it for any other product.
8. Canon reserves the right to change the specifications, configuration and appearance of the product without
prior notice.
European Union (and EEA*) only.
This symbol indicates that this product is not to be disposed of with your household
waste, according to the WEEE Directive (2002/96/EC) and your national law. This
product should be handed over to a designated collection point, e.g., on an
authorized one-for-one basis when you buy a new similar product or to an
authorized collection site for recycling waste electrical and electronic equipment
(EEE). Improper handling of this type of waste could have a possible negative
impact on the environment and human health due to potentially hazardous
substances that are generally associated with EEE. At the same time, your
cooperation in the correct disposal of this product will contribute to the effective
usage of natural resources. For more information about where you can drop off
your waste equipment for recycling, please contact your local city office, waste
authority, approved WEEE scheme or your household waste disposal service.
For more information regarding return and recycling of WEEE products, please
visit www.canon-europe.com/weee
* EEA : Norway, Iceland and Liechtenstein
All rights reserved.
Under copyright laws, this manual may not be copied, in whole or in part, without the written consent
of Canon.
.
000_L-IE-5152E_CF-1.book Page 3 Monday, July 29, 2013 10:30 AM
Safety Information
This instrument conforms to IEC 60601-1-2:2001/A1:2004 and IEC 60601-1-2:2007.
For USA and Canada
•When the CF-1 is going to be operated at a voltage of 240V in USA or Canada, be sure to
connect the instrument to a center tapped voltage source.
•This instrument is CLASS I EQUIPMENT according to UL60601-1.
Regulations
WITH RESPECT TO ELETRIC SHOCK, FIRE MECHANICAL
AND OTHER SPECIFIED HAZARDS ONLY IN
ACCORDANCE WITH CAN/CSA C22.2 NO. 601.1,
MEDICAL EQUIPMENT CERTIFIED FOR CANADA
MEDICAL EQUIPMENT WITH RESPECT
TO ELETRICAL SHOCK, FIRE AND
MECHANICAL HAZARDS ONLY IN
ACCORDANCE WITH UL60601-1
<CONTROL NUMBER 41C4>
•Grounding reliability can only be achieved when the equipment is connected to an equivalent receptacle marked “Hospital Only” or “Hospital Grade”.
•The following mark indicates that the instrument is Type B Applied Parts (forehead rest and
chin rest).
•The degree of protection against ingress of water is IPX0.
•This equipment is not suitable for use in the presence of a flammable anaesthetic mixture
with air, oxygen or nitrous oxide.
•The mode of operation is Continuous Operation.
For EU Countries
•The following mark shows compliance of the instrument with Directive 93/42/EEC.
•This instrument is CLASS I EQUIPMENT according to EN 60601-1:2006 and IEC 606011:2005.
•The following mark indicates that the instrument is Type B Applied Parts (forehead rest and
chin rest) according to EN 60601-1.
•The degree of protection against ingress of water is IPX0.
•This equipment is not suitable for use in the presence of a flammable anaesthetic mixture
with air, oxygen or nitrous oxide.
•The mode of operation is Continuous Operation.
Für Deutschland
•Während des Betriebs liegt der Schalldruckpegel dieses Instruments bei 70 dB(A) oder
weniger gemäß ISO 7779.
-3-
Wavelength [nm]
irradiance (Relative)
000_L-IE-5152E_CF-1.book Page 4 Monday, July 29, 2013 10:30 AM
Safety Information
This report provides information about the hazard to the examinee’s eyes in compliance with
ISO15004 (1997).
1. The spectral characteristics of radiant flux exiting from this instrument are as follows:
1.0
0.8
ISO15004
Observation light at COLOR
Observation light at RED FREE
Observation light at FLUO
0.6
0.4
0.2
0.0
30040050060070080090010001100
2. Photochemical radiance
The photochemical radiances at each photography modes irradiated from this instrument to
the examinee’s eyes are indicated below. All the values in the following table were measured
when the instrument was operating at maximum light intensity and maximum aperture.
La [mW/cm²/sr]Lb [mW/cm²/sr]
(1) Color0.3520.347
(2) Red Free0.0090.009
(3) Fluo0.2520.252
3. The above values are spectrally weighted radiance on the pupil of examinee’s eyes in each
wavelength.
La gives the measure for eyes in which the crystalline lens has been removed (aphakes) or for
eyes of infants. Lb gives this measure for eyes in which the crystalline lens is in place except
for infants’.
Spectrally weighted photochemical radiances La and Lb give a measure of the potential that
exists for a beam of light to cause photochemical hazard to the retina.
-4-
000_L-IE-5152E_CF-1.book Page 5 Monday, July 29, 2013 10:30 AM
According to the American Conference of Governmental Industrial Hygienist (ACGIH) Threshold Limit Values for Chemical Substances and Physical Agents (1995 - 1996 edition),
at photochemical radiances La and Lb of 80 [mW/cm²/sr], 3 minutes irradiation would cause
the retinal exposure dose level to attain the recommended exposure limit.
If the value of radiance was 40 [mW/cm²/sr], 6 minutes would be needed to reach the recommended limit.
That is, the retinal exposure dose for a photochemical hazard is a product of the radiance and
the exposure time.
Since La and Lb of this instrument are extremely low, the risk of the photochemical hazard is
also very low. While no acute optical radiation hazards have been identified for this instrument, it is recommended that the intensity of light directed into the examinee’s eye be limited
to the minimum level which is necessary for diagnosis. Infants, aphakes and persons with diseased eyes will be at greater risk. The risk may also be increased if the person being examined has had any exposure to the same instrument or any other ophthalmic instrument using a
visible light source during the previous 24 hours. This will apply particularly if the eye has been
exposed to retinal photography.
Safety Information
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Safety Information
EMC (Electromagnetic Compatibility)
The CF-1 is designed and tested to comply with IEC 60601-1-2 (EN 60601-1-2), the
applicable regulations regarding EMC for medical devices and must be installed and put into
service according to the EMC information stated as follows.
If this equipment causes harmful interference to other devices, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct the interference by
one or more of the following measures:
•Reorient or relocate the receiving device.
•Increase the separation between the equipment.
•Connect this device into an outlet on a circuit different from that to which the other devices
are connected.
If the problem cannot be solved with the above measures, stop using this equipment and
consult your sales representative or local Canon dealer.
Precautions on EMC
1. 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 manual.
2. Portable and mobile RF communications equipment can affect medical electrical
equipment.
3. Information regarding the cable affecting EMC is as follows.
To maintain the optimum EMC performance, use only the designated cables.
NameTypeLengthRemarks
AC Power cableBH4-62173.0 m fixed-lengthSupplied.
USB cableKU20-3H (Shielded)Max 3.0 mNot Supplied.
USB cableKU20-3H (Shielded)Max 3.0 mNot Supplied.
4. The use of accessories, transducers and cables other than those specified, with the
exception of transducers and cables sold by your sales representative or local Canon
dealer as replacement parts for internal components, may result in increased emissions or
decreased immunity of the CF-1.
5. The CF-1 should not be used adjacent to or stacked with other equipment; if adjacent or
stacked use is necessary, the CF-1 should be observed to verify normal operation in the
configuration in which it will be used.
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000_L-IE-5152E_CF-1.book Page 7 Monday, July 29, 2013 10:30 AM
Guidance and Manufacturer’s Declaration for EMC Directive
Electromagnetic Emissions
The CF-1 is intended for use in the electromagnetic environment specified below.
The user of the CF-1 should assure that it is used in such an environment.
* Not applicable to regions where the rated voltage is less than 220 V.
GROUP 1
Class A
Class A
Complies
The CF-1 uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electromagnetic
equipment.
The CF-1 is suitable for use in all establishments other
than domestic and those directly connected to the public
low-voltage power supply network that supplies buildings
used for domestic purposes.
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000_L-IE-5152E_CF-1.book Page 8 Monday, July 29, 2013 10:30 AM
Safety Information
Electromagnetic Immunity
The CF-1 is intended for use in the electromagnetic environment specified below.
The user of the CF-1 should assure that it is used in such an environment.
Immunity Test
Electrostatic discharge (ESD)
EN IEC 61000-4-2
Electrical fast transient/burst
EN IEC 61000-4-4
Surge
EN IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
EN IEC 61000-4-11
IEC 60601 Test
Level
±(2, 4, 6) kV
contact
±(2, 4, 8) kV air
±2 kV for power
supply lines
±1 kV for input/
output lines
±1 kV differential mode
±2 kV common
mode
<5% U
T
(>95% dip in
U
) for 0.5 cycle
T
40% U
T
(60% dip in UT)
for 5 cycles
70% U
T
(30% dip in UT)
for 25 cycles
Compliance
Level
±(2, 4, 6) kV
contact
±(2, 4, 8) kV air
±2 kV for power
supply lines
±1 kV for input/
output lines
±1 kV differential mode
±2 kV common
mode
<5% U
T
(>95% dip in
U
) for 0.5 cycle
T
40% U
T
(60% dip in UT)
for 5 cycles
70% U
T
(30% dip in UT)
for 25 cycles
Electromagnetic Environment –
Guidance
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
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.
Mains power quality should be that of a
typical commercial or hospital environment. If the user of the CF-1 requires
continued operation during power
mains interruptions, it is recommended
that the CF-1 be powered from an
uninterruptible power supply or a battery.
Power frequency
(50/60 Hz)
magnetic field
EN IEC 61000-4-8
NOTE: U
is the AC mains voltage prior to application of the test level.
T
<5% U
T
(>95% dip in
U
) for 5 sec
T
<5% U
(>95% dip in
U
) for 5 sec
T
3 A/m3 A/m
T
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.
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Safety Information
Immunity Test
Conducted RF
EN IEC 61000-4-6
Radiated RF
EN IEC 61000-4-3
IEC 60601 Test
Level
3 Vrms
150 kHz to 80
MHz
3 V/m
80 MHz to 2.5
GHz
Compliance
Level
3 Vrms
3 V/m
Electromagnetic Environment – Guidance
Portable and mobile RF communications
equipment should be used no closer to
any part of the CF-1, including cables,
than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separations distance
d1.2P=
d1.2 P 80 MHz to 800 MHz=
d2.3 P 800 MHz to 2.5 GHz=
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
a
survey
ance level in each frequency range
, should be less than the compli-
b
.
Interference may occur in the vicinity of
equipment marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflections from structures, objects and people.
a
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 where the CF-1 is used exceeds the applicable RF compliance level above,
the CF-1 should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the CF-1.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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000_L-IE-5152E_CF-1.book Page 10 Monday, July 29, 2013 10:30 AM
Safety Information
Recommended Separation Distances
The CF-1 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the CF-1 can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the CF-1 as recommended below, according to the maximum output power
of the communications equipment.
Rated maximum
output power of
transmitter
W
0.010.120.120.23
0.10.380.380.73
11.21.22.3
103.83.87.3
100121223
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 power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
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.
Separation distance according to frequency of transmitter
m
150 kHz ~ 80 MHz80 MHz ~ 800 MHz800 MHz ~ 2.5 GHz
d1.2 P =d1.2 P =d2.3 P =
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000_L-IE-5152E_CF-1.book Page 11 Monday, July 29, 2013 10:30 AM
General Safety Information
Follow the safety instructions in this manual and all warnings and cautions printed on the warning
labels. Ignoring such cautions or warnings while handling the product may result in injury or accident.
Be sure to read and fully understand the manual before using this product. Keep this manual for future
reference.
To protect the safety of users and others and to prevent accidents, this operation manual utilizes the
symbols and text shown below in warnings and cautions. Read the meanings of these caution signs and
the
Safety Precautions (see page 12), and follow the safety instructions.
Safety Information
Meaning of Caution Signs
WARNING
!
CAUTION
!
NOTE
This indicates a potentially hazardous situation which, if not heeded, could
result in death or serious injury to you or others.
This indicates a hazardous situation which, if not heeded, may result in minor
or moderate injury to you or others, or may result in machine damage.
This is used to emphasize essential information.
Be sure to read this information to avoid incorrect operation.
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000_L-IE-5152E_CF-1.book Page 12 Monday, July 29, 2013 10:30 AM
Safety Information
Safety Precautions
Be sure to follow the safety instructions below to ensure correct operation of the instrument.
Installation and Environment of Use
Do not use or store the instrument near any flammable chemicals such as
alcohol, thinner, or benzine. If chemicals are spilled or evaporate, it may result
WARNING
!
CAUTION
!
in fire or electric shock through contact with electric parts inside the
instruments. Also, some disinfectants are flammable.
Be sure to exercise caution when using them.
Do not use or store the instrument in a location with the conditions listed
below. Otherwise, it may result in failure or malfunction, fall or cause fire or
injury.
• Close to facilities where water is used.
• Where it will be exposed to direct sunlight.
• Close to air-conditioner or ventilation equipment.
• Close to heat source such as a heater.
• Surfaces or areas prone to vibration.
• Insecure place.
• Dusty environment.
• Saline or sulfurous environment.
• High temperature or humidity.
• Freezing or condensation.
CAUTION
!
CAUTION
!
Installation Operation
WARNING
!
Power Supply
WARNING
!
Do not cover the vent holes on the cover.
Otherwise, the temperature in the instrument may rise and cause fire.
Place the instrument on a firm table.
Do not place it extremely near the edge of a table or it may fall and cause
damage or injury.
Do not connect the instrument except in the manner specified.
Otherwise, fire or electric shock may result.
Also, when other equipment is going to be connected to the instrument using
the connector for interface, be sure that leakage current is within the tolerable
value. For details, please contact your sales representative or local Canon
dealer.
Only operate with the type of power supply indicated on the rating label.
Otherwise, fire or electric shock may result.
WARNING
!
Be sure to turn OFF the power before plugging or unplugging the cables as
indicated in this manual. Also, do not handle the cables with wet hands.
Otherwise, you may get an electric shock that may result in death or serious
injury.
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000_L-IE-5152E_CF-1.book Page 13 Monday, July 29, 2013 10:30 AM
Power Supply
Securely plug in the power cable into the AC outlet.
WARNING
!
WARNING
!
WARNING
!
If contact failure occurs, or if dust or a metal object comes in contact with the
exposed metal prong of the plug, fire or electric shock may result.
Be sure to hold the plug to disconnect the power cable.
If you pull the cable, the core wire may be damaged, resulting in fire or electric
shock.
Do not cut or process the cables. Also, do not place anything heavy on the
cables (including the instrument). Do not step on, pull bend, or bundle the
cables.
Otherwise, the cable may be damaged, which may result in fire or electric
shock.
Safety Information
WARNING
!
CAUTION
!
CAUTION
!
CAUTION
!
Handling
WARNING
!
WARNING
!
Do not get the power for more than one instrument from the same AC outlet.
Otherwise, it may result in fire or electric shock.
Before connecting or disconnecting the cables, be sure to hold the instrument
firmly in order to ensure safety.
Otherwise, the main unit may fall over, possibly causing injury.
The instrument is shipped with a grounding type (three-core) power cable. To
avoid the risk of electric shock, this equipment must only be connected to a
supply mains with protective earth.
To make it easy to disconnect the plug at any time, avoid putting any
obstacles near the outlet.
Never disassemble or modify the product as it may result in fire or electric
shock. Also, since the instrument incorporates high-voltage parts that may
cause electric shocks and other hazardous parts, touching them may cause
death or serious injury.
Do not place anything on top of the instrument.
Otherwise, the object may fall and cause injury.
Also, if metal objects such as a needle or clip falls into the instrument, or if
liquid is spilled, it may result in fire or electric shock.
WARNING
!
WARNING
!
WARNING
!
When the instrument is going to be moved, be sure to turn OFF the power,
unplug the power cable from the AC outlet, and disconnect other cables.
Otherwise, the cable may be damaged, which may result in fire or electric
shock.
When the instrument is going to be carried, be sure to tighten the stage unit
lock, hold the indentations for lifting at the left and right of the bottom panel
and hold the instrument horizontally.
Do not hold it by the digital camera or the head rest poles or other parts, as
they may come off and result in injury.
Do not hit or drop the instrument. The instrument may be damaged if it
receives a strong jolt, which may result in fire or electric shock if the
instrument is used without first being repaired.
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000_L-IE-5152E_CF-1.book Page 14 Monday, July 29, 2013 10:30 AM
Safety Information
Handling
To prevent the risk of infection, wipe the forehead rest with disinfectant
CAUTION
!
ethanol for each patient. For details on how to disinfect, consult a specialist.
The forehead rest may be corroded if a disinfectant other than those above is
used.
CAUTION
!
CAUTION
!
CAUTION
!
CAUTION
!
CAUTION
!
To ensure cleanliness, replace the chin rest paper for each patient.
When adjusting the forward position of the main unit, be sure to move the
main unit slowly toward the patient while looking from the side of the patient,
to prevent accidental contact of the objective lens with the patient.
Do not place your hands or fingers or allow the patient to place his/her hands
or fingers between the stage and base. Otherwise, injury may occur.
When the instrument is not going to be used, turn OFF the power.
Also, unplug the power cable from the AC outlet when it is not going to be
used for long periods of time.
The instrument weighs approximately 26 kg (57 Ibs). Be sure that at least two
people lift the instrument to transport it and that it is lifted by gripping the
indentations for lifting. Otherwise, injury may occur.
When Problem Occurs
Should any of the following occur, immediately turn OFF the power of each
instrument, unplug the power cable from the AC outlet, and contact your sales
representative or local Canon dealer.
WARNING
!
•When there is smoke, an odd smell or abnormal sound.
•When liquid has been spilled into the instrument or a metal object has
•When the instrument has been dropped and it is damaged.
entered through an opening.
Maintenance and Inspection
For safety reasons, be sure to turn OFF the power when the inspections
WARNING
!
WARNING
!
WARNING
!
indicated in this manual are going to be performed. Otherwise, electric shock
may result.
When the instrument is going to be cleaned, be sure to turn OFF the power,
and unplug the power cable from the AC outlet.
Never use alcohol, benzine, thinner or any other flammable cleaning agents.
Otherwise, fire or electric shock may result.
Clean the plug of the power cable periodically by unplugging it from the AC
outlet and removing dust or dirt from the plug, its periphery and AC outlet with
a dry cloth. If the cable is kept plugged in for a long time in a dusty, humid or
sooty place, dust around the plug will attract moisture, and this could cause
insulation failure which could result in a fire.
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Maintenance and Inspection
Safety Information
WARNING
!
CAUTION
!
CAUTION
!
System Use
WARNING
!
WARNING
!
WARNING
!
WARNING
!
WARNING
!
The instrument must be repaired by a qualified engineer only.
If it is not repaired properly, it may cause fire, electric shock, or accident.
For safety reasons, be sure to inspect the instrument before using it.
Always take a test image to check that there is no foreign matter present that
can affect image readings before using the instrument (see page 44).
Do not place multiple portable socket-outlets on the floor. Otherwise, fire or
electric shock may result.
Do not connect an additional multiple portable socket-outlet or extension cord
to the system. Otherwise, fire or electric shock may result.
Do not connect instruments that are not specified as part of the system.
Otherwise, fire or electric shock may result.
For the system, use a power transformer of 1000 VA of the maximum
permitted load. Otherwise, fire or electric shock may result.
Use multiple portable socket-outlets only for supplying power to equipment
that is intended to form part of the system. Otherwise, fire or electric shock
may result.
WARNING
!
WARNING
!
WARNING
!
CAUTION
!
CAUTION
!
Do not connect non-medical electrical equipment that has been supplied as a
part of the system to any power socket other than the multiple socket-outlets
for the system. Otherwise, electric shock may result.
Do not connect any electrical equipment that has not been supplied as a part
of the system to the multiple portable socket-outlets for the system.
Otherwise, fire or electric shock may result.
Do not simultaneously touch a patient and non-medical electrical equipment.
Otherwise, electric shock may result.
For cleaning equipment forming part of the system, follow the instruction
manual for the equipment. Otherwise, it may cause failure, an accident, or
fire.
Install the system in a way that enables the user to achieve optimal use.
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000_L-IE-5152E_CF-1.book Page 16 Monday, July 29, 2013 10:30 AM
Safety Information
Labels and Markings on the Instrument
The CF-1 has a label on it.
The label contents and its position are indicated below.
-16-
For 110-120V Countries
For 230-240V Countries
000_L-IE-5152E_CF-1.book Page 17 Monday, July 29, 2013 10:30 AM