Operating Instructions

Operating Instructions
Intraoral Camera
EJ-CA02EPA
≥ Please read these instructions carefully before using this product, and save these instructions for
future use.
≥ The information contained in the Safety Precautions (P. 4 – P. 8) is important for the safe and
reliable operations of the product. Read and understand the information thoroughly before
attempting to set up and operate the product.
≥ Compliant with medical safety standards
This design complies with EN 60601-1, ANSI/AAMI ES 60601-1 and CAN/CSA-C22.2 NO.
60601-1-08 safety standards, meeting the requirements for use in the medical field.
Customer’s Record
The serial number of this product can be found on the Logo sheet of Camera handpiece. You
should note this serial number in the space provided below and retain this book, plus your
purchase receipt, as a permanent record of your purchase to aid identification in the event of
theft or loss, and for Warranty Service purposes.
Model Number
Serial Number
Other
Using with a PC
Preparation
Model No.
Safety Precautions
Operating Instructions
Introduction
This Intraoral Camera can capture and display the inside of a patient’s mouth, when it is connected
to the USB 2.0 terminal of the PC and supplied the power from it.
This product achieves accurate color reproducibility inside the mouth, and it helps you to capture
clear images the first time around with its auto focus and stabilization correction features.
The product is intended to be used to assist in providing explanations to your patients. Captured
pictures are not intended to be used for an image diagnosis.
Note . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2
To the customer:
This product is a medical device, and the user must be completely
familiar with its operation. Read thoroughly each of the items in the
Operating Instructions.
To the dealer:
After attaching the product, be sure to adequately explain each of the
items in these Operating Instructions to the customer to ensure safety.
Table of Contents
Read “Safety Precautions” (P.4 – P.8) thoroughly before use.
Safety Precautions
Safety Precautions
(These must be observed) . . . . . . . . . . . . 4
Information for your safety . . . . . . . . . . . 8
Preparation
Before using . . . . . . . . . . . . . . . . . . . . . . . 9
Safety Precautions
Introduction . . . . . . . . . . . . . . . . . . . . . . . 2
Accessories . . . . . . . . . . . . . . . . . . . . . . . . 10
Recommended Disposable cover. . . . . . . 10
Product display symbols . . . . . . . . . . . . . . 13
Fitting / Removing the
Disposable cover . . . . . . . . . . . . . . . . . . . . 15
Using with a PC
Operating environment for EJ-CA02EPA. . . 18
Preparation
Part names and functions . . . . . . . . . . . . 11
Connecting to a PC . . . . . . . . . . . . . . . . . . 19
Disconnecting from a PC . . . . . . . . . . . . . 20
Maintenance . . . . . . . . . . . . . . . . . . . . . . . 21
Troubleshooting . . . . . . . . . . . . . . . . . . . . 22
Specifications . . . . . . . . . . . . . . . . . . . . . . 23
EMC Relevant Information . . . . . . . . . . . 24
Other
Other
Using with a PC
Capturing images and Playing back
images on a PC . . . . . . . . . . . . . . . . . . . . . 20
3
Safety Precautions
(These must be observed)
The following symbols describe the need to observe certain content in order to prevent
human injury or damage to property.
? These describe and classify the degree of injury or damage that
occurs with incorrect use.
WARNING
This indicates “content that involves a risk of
serious injury or death”.
CAUTION
This indicates “content that involves a risk of
injury or damage to property”.
? The following symbols describe content to be observed. (The
following symbols are examples.)
This indicates “content that must NOT be performed”.
This indicates “content that MUST be performed”.
WARNING
Use the Intraoral Camera after fitting the specified
Disposable cover (#290VP07).
Using the Intraoral Camera without fitting the specified Disposable cover
could cause infection, device breakage and accidental ingestion of broken
parts.
Use a new Disposable cover for each patient.
Reusing the Disposable cover could cause infection.
Before and after using the product, wipe it with gauze
or a similar material containing ethanol for disinfection.
Using the product in an unsanitary condition could cause infection.
4
Do not use a torn Disposable cover.
If you use a torn Disposable cover, it may cause infection or the Camera
handpiece malfunction.
Do not use a damaged Camera handpiece.
This could cause accidental ingestion of damaged parts or electric shock.
The PC connected to this product must conform to IEC
60950-1 or IEC 60601-1.
Safety Precautions
WARNING
When connecting this product to other devices, there is a risk that the
leakage current may increase.
The combination and installation shall conform to IEC 60601-1:2005.
Any person who connects this product is responsible for ensuring that the
system conforms to IEC 60601-1:2005.
If there is anything that you do not understand, please contact the dealer
where this product was purchased.
If there is lightning or thunder, do not touch the
product or the devices to which it is connected (PC, USB
plug).
This could cause electric shock.
Do not damage the Camera cable.
(Do not scratch, modify, put near hot devices, forcibly
turn, twist, tug, place heavy items upon, or knot).
Using these when damaged could cause fire, electric shock or
short-circuiting.
≥ For repairs of the cable, please contact your dealer.
Only the supplied Camera cable (LSYC2149) should be
used.
Using a cable other than the one supplied with this product could cause
electric shock or short-circuiting.
When the LED light of the product is illuminated, do not
look directly into the LED light from close-up, and do not
shine it in a person's eyes.
This product uses IEC 60825-1 class I LED. Intense light could hurt the
eyes.
5
Safety Precautions (These must be observed)–Continued
WARNING
Do not directly touch the product for a long period of
time with the power turned on.
The temperature of the LED light exceeds 41 °C (it reaches to maximum
46 °C after 10 minutes of use). In order to prevent burns caused by heat,
be careful not to let the LED light part continuously touch the inside of the
patient's mouth.
Direct, prolonged contact with the hot parts of the product could cause
low-temperature burns*.
* Persons that have poor blood flow (vascular disorders, blood
circulation impairment, diabetes, high blood pressure) or persons that
have weak skin sensation, etc. tend to get low-temperature burns.
Do not use this product near persons that use
pacemakers and other similar devices.
The radio waves from this product could affect the operation of
pacemakers, etc.
Do not use the Camera handpiece when it is wet.
This could cause electric shock or product malfunction.
Do not pour water on or wet the product.
This product does not have water proof structure. Water getting inside the
product could cause fire, electric shock, or product malfunction.
If water gets inside the product, contact your dealer.
Do not disassemble or modify the product.
≥ Order repairs and inspections of the inside of the product from your
dealer.
Operator must not touch the patient and the PC
connected to this product simultaneously.
This could cause electric shock.
Prevent a patient from touching the PC connected to
this product.
Camera handpiece and Camera cable are suitable for use within the
patient environment.
6
Operator must not touch the patient and the metal part
of Camera cable connected to the PC simultaneously.
This could cause electric shock.
Do not connect additional multiple socket-outlets or
extension cord for power supply to the Intraoral
Camera system.
Safety Precautions
WARNING
This could cause electric shock.
CAUTION
To avoid an infection risk, when disposing of this Intraoral
Camera, you must obey the laws applicable in your area and
country and comply with the regulations of your hospital.
When performing maintenance or when the product is
not to be used for a long period of time, disconnect the
USB plug to ensure safety.
Leaving or storing while plugged in could cause insulation degradation,
short-circuiting, etc., which could cause a fire.
In the following situations, stop using it and disconnect
the USB plug;
— smoke rise from the product,
— the product is abnormally hot,
— the product smells burnt,
— abnormal noise is heard from the product,
— if water or foreign bodies get inside the product,
— the external case of the product is damaged.
Continuing to use the product could cause fire or electric shock.
Do not place the product in an unstable location (On an
uneven table or an incline, etc.).
If the product falls, this could cause injury or product malfunction.
7
Information for your safety
General
≥ Please read these safety instructions carefully.
≥ Please keep this Operating Instructions for later reference.
To prevent the damage
≥ Do not drop or knock this product or put a lot of pressure on it. This may damage this product.
≥ Do not expose this product to excessive heat or direct sunlight as to avoid the risk of fire.
≥ Handle this product with care. Rough handling will damage its internal components.
Use this product in the appropriate position
≥ To avoid risk of electrical damage, keep this product away from fluids and chemicals.
≥ Do not use this product near inadequately shielded medical devices.
≥ Do not use this product near electromagnetic equipment, radio transmitters or high voltage lines.
Do not use this product in the following locations
≥ In environments with a high oxygen content in the atmosphere.
≥ In proximity to anesthetic gas (i.e. in a flammable atmosphere).
≥ In an atmosphere containing oxidized materials.
For cleaning or storage
≥ Please disconnect this product from USB 2.0 terminal before cleaning. Do not use liquid or sprayed
detergent for cleaning. Use moisture sheet or cloth for cleaning.
≥ Please keep this product away from humidity.
Contact to the dealer
≥ Do not remove any parts of this product. Contact an authorized dealer in your area.
≥ If one of the following situations arises, get this product checked by service personnel:
- The Camera cable or USB plug is damaged.
- Liquid has penetrated into this product.
- This product has been exposed to moisture.
- This product has not worked well or you can not get it work according to Operating
Instructions.
- This product has dropped and damaged.
- If this product has obvious sign of breakage.
8
Before using
Handling this product
≥ Do not touch the lens or terminal with hands. Also, be careful to prevent liquid and foreign
materials from getting into the product from the lens or button gaps.
≥ Do not bend, tug and twist the joint of the Camera handpiece and the Camera cable to avoid
damaging the Camera cable.
≥ Do not use devices that emit electromagnetic radiation near this product. The electromagnetic
radiation emitted by communication devices such as mobile phones, transceivers, etc. can affect
this device and lead to glitches that cause the product to malfunction.
In a clinical setting, instruct that these communication devices be turned off.
≥ Do not use lights that emit electromagnetic radiation near this product. The electromagnetic
radiation emitted from an inverter operation light (film viewer, fluorescent light, etc.) could affect
the image.
Indemnity about recorded content
≥ Panasonic does not accept any responsibility for damages directly or indirectly due to any type of
problems that result in loss of recorded content, and does not guarantee any content if recording
does not work properly.
Preparation
≥ When operating or transporting this product, hold the main part of the Camera handpiece. If the
product is held dangling by grabbing the Camera cable, the Camera handpiece could hit the floor
or other medical devices, causing it to become damaged or to malfunction.
Safety Precautions
≥ Do not exert strong shocks or vibrations on the product by dropping it, hitting it, etc. Also, do not
apply strong pressure to the product. This could cause the product to malfunction, impossible
recording, or damage to occur to device parts such as the lens.
9
Accessories
Check the accessories.
Camera cable ···1
LSYC2149
Cable bush for silicon tube ···1
LSMG0238
* 2.3 m/Shielded
* Detachable parts
* Detachable parts
Operating Instructions ···1
LSQT1719
Recommended Disposable cover
The following Disposable cover shall be used with this product.
Optiview Camera Sheaths
Model No.: 290PV07
500 sheets/Box
For Purchasing Disposable covers
Contact Sinclair for information related to purchasing Disposable covers.
10
Part names and functions
Camera handpiece
In this document, the main unit part of the product (figure below) is called the Camera handpiece.
(Excluding the cable)


   


≥ Camera handpiece (excluding the Camera cable) is the BF type applied part.
1 POWER indicator
POWER indicator shows status of this product as table below.
Operating State
POWER indicator
Status
Operating
Glows Green
Normal
Standby
No power supply
Glows Orange
Normal
Flashes Orange
Malfunction
Goes out
Disconnected
Preparation
Note:
The following case, please see the troubleshooting. (P.22)
≥ Status shows malfunction.
≥ POWER indicator goes out when the Camera handpiece and the Camera cable are connected.
2 POWER button
Switch the state Operating and Standby.
3 ZOOM button
This switches the modes of the product as shown below.
Normal # Zoom # Normal (return)
≥ In Zoom mode, the image is displayed 1.5 times larger than the Normal.
≥ Once the Power goes to Standby, Zoom mode returns to Normal.
<Normal>
<Zoom>
x 1.5
11
Part names and functions – Continued
4 LIGHT button
Turns the LED light on or off. When goes to Operating, the LED light automatically turns on.
Note:
≥ When capturing extraoral images, turn off the LED light. Failure to do so could
result in images becoming unclear.
5 Shutter button
This captures still pictures. The button is in 2 places, top and bottom.
The button that is easiest to press can be used according to the direction of the lens.
When the lens is turned upward
When the lens is turned downward
6 LED light
The light illuminates objects.
7 Lens
This is the Lens which captures still and moving pictures. The front surface of the lens is
protected by cover glass.
8 Camera cable
This connects to the Camera handpiece and the USB 2.0 terminal on the PC.
12
Product display symbols
These describe the symbols displayed on the product and the meaning of those symbols.
The device complies with the Medical Device Directive 93/42/EEC.
Type BF Applied Part
This symbol indicates this product complies with requirements for the BF type
applied part according to IEC 60601-1.
European Commission Directive 2002/96/EC related to the disposal of electric
and electronic devices applies to this product.
USB plug
Preparation
LED light
POWER ON
STANDBY
Serial number
Manufacturer and/or Manufacturing date
Authorised representative in the European community
Consult operating instruction for use.
Temperature limits
13
Product display symbols – Continued
Keep away from rain
Fragile
Stacking limit by number
This way up
Recycling symbol for corrugated cardboard used for packaging
Weight
14
Fitting / Removing the Disposable cover
To prevent infection, damage to the product, and accidental ingestion of
parts, the specified Disposable cover (290PV07) must be used.
≥ Use a new Disposable cover for each patient. The Disposable cover must not be reused.
≥ Check that the Disposable cover is not torn before use.
≥ Do not use the Camera handpiece when it is wet. This could cause infection or product
malfunction. Before fitting the Disposable cover, wipe the Camera handpiece with a clean, soft
cloth, such as gauze.
≥ Condensation on the Disposable cover could cause images to be unclear. If the image is unclear,
remove the product from the patient's mouth, and wipe the part of the Disposable cover that
covers the lens with a clean, soft cloth, such as gauze, then use.
≥ For reasons of hygiene, wear gloves when fitting and removing the Disposable cover, and dispose
of used covers in an appropriate manner.
≥ When handling a Disposable cover with powdered gloves, it may be difficult to fit and remove the
cover because the gloves slip. Use non-slip gloves and powder-free gloves.
≥ Store Disposable covers in a cool location away from sunlight.
≥ To avoid an infection risk, when disposing of the Disposable cover, you must obey the laws
applicable in your area and country and comply with the regulations of your hospital.
Fitting
1
Turn the Camera handpiece Lens downward. Hold the Disposable
cover and insert the camera between the white tab and the paper
with the optical side facing the paper.
2
Gently slide the camera until the camera head reaches the tip of the
Disposable cover.
Preparation
Observe the following when fitting or removing the Disposable cover.
≥ Insert the camera to the cover so that the Camera handpiece is almost covered.
15
Fitting / Removing the Disposable cover – Continued
3
Peel back the protective top cover.
4
Peel away the paper backing.
5
Apply gentle pressure downward so sleeve is tight.
Note:
≥ When fitting the Disposable
cover, do not bend, tug and twist
the joint of the Camera
handpiece and the Camera cable
to avoid damaging the Camera
cable.
16
Removing
1
Pinch the hem of the Disposable cover.
2
Turn the Disposable cover toward the
front end of the Camera handpiece.
Note:
≥ When removing the Disposable cover, do not bend, tug and twist the joint of the Camera
handpiece and the Camera cable to avoid damaging the Camera cable.
Preparation
≥ Turn the Disposable cover over.
Purchasing Disposable covers
Contact Sinclair for information related to purchasing Disposable covers.
17
Operating environment for EJ-CA02EPA
Supported
PCs
IBM PC/AT compatible personal computer
Mac
(IEC 60950-1 applicable products)
Application
software
UVC (USB Video Class) 1.0 compliant software
Interface
USB terminal (high-speed USB (USB2.0))
Other
Keyboard
Mouse or mouse-like pointing device
Limitations
≥ Operation cannot be guaranteed for all PCs in the recommended environment.
≥ Operation on Tablet PC cannot be guaranteed.
≥ Operation cannot be supported on the NEC PC-98 series and compatible machines thereof.
≥ Operation is not guaranteed when 2 or more of Intraoral Camera have been connected to 1 PC or
when Intraoral Camera is connected with a USB hub or USB extension cable.
Notes
≥ Frame dropping, noise, or a slowdown of software operation could occur when capturing moving
pictures if the CPU or memory is not fulfilling the requirements of the operating environment.
≥ Always use the most current driver for the video card.
≥ Always make sure there is enough capacity on the HDD in the PC. It may become inoperable or the
operation may stop suddenly if the capacity gets low.
Trademarks / Licenses
≥ IBM and PC/AT are registered trademarks of International Business Machines Corporation of the
U.S.
≥ Mac is a trademark of Apple Inc., registered in the U.S. and other countries.
≥ In addition, listed names, company names and product names are a trademark or a registered
trademark of each company.
18
Connecting to a PC
This Intraoral Camera system is composed as following figure.
Camera handpiece
Camera cable
PC (IEC 60950-1 applicable product)
Camera handpiece
ヒ
Camera cable
ビ
PC
Connect the attachment plug of Camera cable to the Camera handpiece.
1 Align all Marks of the
Camera handpiece and
the Plug and the Projected
part.
Insert the Plug into the
deep inside of the Camera
handpiece.
Camera handpiece
Mark
Plug
Mark
Camera cable
Projected part
2 Rotate the Plug 45
degrees clockwise and
lock the connection.
Confirm that positions of
the Dot and the Mark are
aligned.
Using with a PC
1
rotate 45 degrees
Dot
Mark
19
Connecting to a PC – Continued
Note:
≥ Do not insert or rotate the Plug forcibly.
≥ When disconnecting the Camera cable from the Camera handpiece, perform the reverse
procedure of connecting the Camera cable.
2
Connect a USB terminal of the PC.
Disconnecting from a PC
1
Press the POWER button on the Camera handpiece to be Standby
mode.
2
Disconnect the USB plug from a USB terminal of the PC.
Capturing images and Playing back
images on a PC
You can capture and playback images on your PC using application software for image management
or viewer UVC 1.0 compliant.
For details of capturing images and playing back images, refer to operating instructions of your
software.
20
Maintenance
Daily maintenance
When performing maintenance, disconnect the USB plug.
Main unit: Camera handpiece
≥ Use clean gauze containing ethanol for disinfection to wipe away the dirt. If the amount of
ethanol for disinfection is too great when doing this, it might seep into the main unit from the
connection parts, causing the product to malfunction. Also, do not disinfect by soaking or
spraying.
≥ When the lens surface is dirty, a clear image cannot be captured. The lens must be cleaned.
Gently wipe the lens surface.
≥ Because the quality or shape of the Camera handpiece could be altered, do not use the
following disinfectants, solvents, detergents, etc.
- Chemicals containing acetone, iodine, or phenols
- Organic solvents such as benzine and thinner
- Detergents such as kitchen detergent
≥ Also, if chemicals besides those used for daily maintenance get on the product, immediately
wipe them away with ethanol for disinfection.
≥ Do not perform sterilization treatment using an autoclave or similar device. This could cause the
product to malfunction.
Camera cable
≥ Wipe with a soft cloth that contains a neutral detergent.
≥ When performing the maintenance of the Camera cable, do not bend, tug and twist it to avoid
damaging the Camera cable.
Setting / storage location
Use care in selecting the setting / storage location. Not doing so could cause the product to
malfunction.
≥ The acceptable ranges for ambient temperature, relative humidity, and atmospheric pressure are
shown below.
Ambient temperature
Relative humidity
Atmospheric pressure
Usage
conditions:
5 eC to 35 eC
10 % to 80 %
700 hPa to 1060 hPa
Storage and
transport
conditions:
—20 eC to 60 eC
5 % to 90 %
700 hPa to 1060 hPa
≥ Do not expose to direct sunlight for a long period of time.
Other
Check that there are no chips, cracks or dirt in the Camera handpiece or Camera cable.
Do not use damaged devices.
Before use, check that each part is operating correctly and safely. Not doing so could cause
unexpected accidents or malfunction.
Using with a PC
Daily check
≥ Do not place in an unstable location.
≥ Do not use with a base of Camera cable bent.
≥ When using a product that has not been used for a long period of time, you must check that it
operates normally and safely before use.
21
Troubleshooting
Even if it appears that something is malfunctioning, it might be quickly fixed with a small operation
or careful attention. Before ordering repairs from a dealer, check the following items.
If the condition does not improve, contact the dealer where the product was purchased.
Question
Moving pictures do not
appear on the PC screen
Images are not clear
POWER indicator goes out
(The power cannot be
turned on)
POWER indicator flashes
22
Answer
≥ Check that the main screen of your viewer application is displayed
on the PC.
≥ Check that the Camera cable is securely inserted into the USB 2.0
terminal on the PC.
≥ Check that the Disposable cover is not dirty.
≥ Check that the lens cover glass is not dirty.
≥ Check that the USB plug is securely inserted all the way to its base
into the USB 2.0 terminal on the PC.
≥ Check that the Camera cable is securely inserted into the Camera
handpiece.
≥ Contact the dealer where the product was purchased.
Specifications
General
Usage conditions:
ambient temperature / relative
humidity / atmospheric pressure
Ambient temperature: 5 °C to 35 °C
Relative humidity: 10 % to 80 %
Atmospheric pressure: 700 hPa to 1060 hPa
Storage and transport conditions:
ambient temperature / relative
humidity / atmospheric pressure
Ambient temperature: —20 °C to 60 °C
Relative humidity: 5 % to 90 %
Atmospheric pressure: 700 hPa to 1060 hPa
Applied part classification
Type BF applied part
Power consumption
DC 5 V 0.38 A
Camera handpiece
Main unit dimensions
237 mm k 29.5 mm k 36 mm (length k width k height)
Mass
Approx. 210 g (with Camera cable)
PC interface
USB2.0 (High speed)
USB Device Class
UVC 1.0
Imaging device
1/4 inches CMOS sensor (1.5 million pixels)
Effective pixels
1 430 000 pixels
Pixels of image
640 k 480 pixels (VGA)
5-group 6-element Auto Iris installed Open F-number 4.0
Lens
Focal length 2.1 mm (35 mm film equivalent: 39.5 mm)
Video image contrast detection
Focus method (auto)
LED light
White LED 4 lights
Stabilization correction
Still picture: High-speed shutter
Moving picture: Digital image stabilization
Camera cable length
2.3 m
IP Code
IPX0
Other
Focus range: 0 mm to ¶
23
EMC Relevant Information
1 .The EJ-CA02EPA needs special precautions regarding EMC and needs to be installed and put into
service according to the following EMC information.
2.The portable and mobile RF communications equipment can affect the EJ-CA02EPA.
3.WARNING: The EJ-CA02EPA should not be used adjacent to or stacked with other equipment.
If adjacent or stacked use is necessary, the EJ-CA02EPA should be observed to verify normal
operation in the configuration in which it will be used.
4.WARNING: The uses of accessories, transducers and cables, with the exception of transducers and
cables sold by the manufacturer as replacement parts, may result in increased emissions or
decreased immunity of the EJ-CA02EPA.
5.The EJ-CA02EPA is tested EMC to use general PC complied with IEC 60950-1.
6.Tests related to the AC power supply are not applicable. The EJ-CA02EPA is not connected to the
public power supply and be supplied the power from USB terminal on a PC.
Guidance and manufacturer’s declaration - electromagnetic emissions
The EJ-CA02EPA is intended for use in the electromagnetic environment specified below. The
customer or the user of the EJ-CA02EPA should assure that it is used in such an environment.
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
24
Compliance
Group 1
Class A
Harmonic emissions
IEC 61000-3-2
Not applicable
Voltage
fluctuations/flicker
emissions
IEC 61000-3-3
Not applicable
Electromagnetic environment - guidance
The EJ-CA02EPA 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 electronic
equipment.
The EJ-CA02EPA 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.
Guidance and manufacturer’s declaration - electromagnetic immunity
The EJ-CA02EPA is intended for use in the electromagnetic environment specified below. The
customer or the user of the EJ-CA02EPA should assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance level
Electromagnetic environment guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± (2, 4, 6) kV
contact
± (2, 4, 8) kV air
± (2, 4, 6) kV
contact
± (2, 4, 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
IEC 61000-4-4
± 1 kV for
interconnecting
cable
± 1 kV for
interconnecting
cable
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
Not applicable
Not applicable
Voltage dips,
short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5 %
(>95 % dip in
for 0.5 cycle
Not applicable
Not applicable
3 A/m
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
40 %
(60 % dip in
for 5 cycles
)
70 %
(30 % dip in
for 25 cycles
)
<5 %
(>95 % dip in
for 5 sec
Power frequency
(50 Hz/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
)
is the a.c. mains voltage prior to application of the test level.
Other
NOTE
)
25
EMC Relevant Information – Continued
Guidance and manufacturer's declaration - electromagnetic immunity
The EJ-CA02EPA is intended for use in the electromagnetic environment specified below. The
customer or the user of the EJ-CA02EPA should assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic environment - guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the EJ-CA02EPA, including cables,
than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to
80 MHz
3 Vrms
d =1.2
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to
2.5 GHz
3 V/m
d =1.2
80 MHz to 800 MHz
d =2.3
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
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:
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 reflection from structures, objects and people.
26
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 in which the EJ-CA02EPA is used exceeds the
applicable RF compliance level above, the EJ-CA02EPA should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as
re-orienting or relocating the EJ-CA02EPA.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between
portable and mobile RF communications equipment and the EJ-CA02EPA
The EJ-CA02EPA is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the EJ-CA02EPA can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the EJ-CA02EPA as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
d =1.2
80 MHz to 800 MHz
d =1.2
800 MHz to 2.5 GHz
d =2.3
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
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.
Other
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.
27
Information on Disposal for Users of Waste Electrical & Electronic Equipment
(private households)
This symbol on the products and/or accompanying documents means that
used electrical and electronic products should not be mixed with general
household waste.
For proper treatment, recovery and recycling, please take these products to
designated collection points, where they will be accepted on a free of charge
basis. Alternatively, in some countries you may be able to return your products to
your local retailer upon the purchase of an equivalent new product.
Disposing of this product correctly will help to save valuable resources and prevent
any potential negative effects on human health and the environment which could
otherwise arise from inappropriate waste handling. Please contact your local
authority for further details of your nearest designated collection point.
Penalties may be applicable for incorrect disposal of this waste, in accordance with
national legislation.
For business users in the European Union
If you wish to discard electrical and electronic equipment, please contact your dealer
or supplier for further information.
Information on Disposal in other Countries outside the European Union
This symbol is only valid in the European Union.
If you wish to discard this product, please contact your local authorities or dealer and
ask for the correct method of disposal.
D
Panasonic Marketing Europe GmbH
Hagenauer Str. 43 65203 Wiesbaden, Germany
+49-611-235-0
Panasonic Testing Centre
a Division of Panasonic Marketing Europe GmbH
Winsbergring 15, 22525 Hamburg, Germany
Panasonic Healthcare Co., Ltd.
247 Fukutake-ko, Saijo, Ehime 793-8510, Japan
Printed in Japan
F0612-1062
LSQT1719-1
2012-06-21
C Panasonic Healthcare Co., Ltd. 2012
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