Canon CXDI-50G Bedienungsanleitung

DIGITAL RADIOGRAPHY

Before using the instrument, be sure to read this manual thoroughly.

Also, read the manuals of other instruments in the system.

Keep the manual where it is easily accessible.

User’s Manual

PLEASE NOTE

1. The user is responsible for the use and maintenance of the product.

We suggest that a member of the user’s staff be designated as being in charge of mainte-

nance so as to ensure that the product is kept in a safe and good condition.

Also, medical products must be used only by a qualified person.

2. Roentgenography, image processing, reading of image, and storage of data must be per-

formed 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.

3. 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 due to any reason.

4. This product may malfunction due to electromagnetic waves caused byportable personal

telephones, transceivers, radio-controlled toys, etc. Be sure to avoid having objects such

as these, which affect this product, brought near the product.

5. Canon reserves the right to change the specifications, configuration and appearance of

the product without prior notice.

System and product names in this manual are the trademarks of each manufacturer that

developed them.

Under copyright laws, this manual may not be copied, in whole or in part, without the written

consent of Canon.

(1)

Safety Information

Regulations

For U.S.A.

Do not make any changes or modifications to the equipment unless otherwise specified in the

manual. If such changes or modifications should be made, you could be required to stop oper-

ation of the equipment.

NOTE: This equipment has been tested and found to comply with the limits for a Class A dig-

ital device, pursuant to Part 15 of the FCC rules.

These limits are designed to provide reasonable protection against harmful interfer-

ence when the equipment is operated in a commercial environment.

This equipment generates, uses, and can radiate radio frequency energy and, if not

installed ad used in accordance with the instruction manual, may cause harmful inter-

ference to radio communications.

Operation of this equipment in a residential area is likely to cause harmful interfer-

ence in which case the user will be required to correct the interference at his own

expense.

Use of shielded cable is required to comply with class A limits in Subpart B of Part 15 of FCC

rules.

This instrument is a CLASS IEQUIPMENT according to UL2601-1.

MEDICAL ELECTRICAL EQUIPMENT

WITH RESPECT TO ELECTRIC SHOCK,

FIRE AND MECHANICAL HAZARDS

ONLY IN ACCORDANCE WITH UL2601-1.

41C4

WITH RESPECT TO ELECTRIC SHOCK,

FIRE , MECHANICAL AND OTHER SPECIFIED HAZARDS ONLY

IN ACCORDANCE WITH CAN/CSA C22.2 NO. 601.1,

MEDICAL EQUIPMENT CERTIFIED FOR CANADA

For EU Countries

The following mark shows compliance of the instrument with Directive 93/42/EEC.

This instrument complies with the standards EN60601-1, EN60601-1-1, EN601-1-2, EN601-1-

3 and EN60601-2-32.

This instrument conforms to IEC 60601-1-2:2001.

This instrument is a CLASS IEQUIPMENT according to EN 60601-1.

(2)

Safety Information

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

The CXDI-50G is intended for use in the electromagnetic environment specified below.

The user of the CXDI-50G should assure that it is used in such an environment.

Emission Test Compliance Electromagnetic Environment – Guidance

RF emissions

CISPR 11 GROUP 1 The CXDI-50G uses RF energy only for its internal func-

tion. Therefore, its RF emissions are very low and are not

likely to cause any interference in nearby electromagnetic

equipment.

RF emissions

CISPR 11 Class A The CXDI-50G 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.

Harmonic emissions

IEC 61000-3-2 Not Applica-

ble

Voltage fluctuations/

flicker emissions

IEC 61000-3-3

Complies

Immunity Test IEC 60601

Test Level Compliance

Level Electromagnetic Environment – Guidance

Electrostatic dis-

charge (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 syn-

thetic material, the relative humidity

should be at least 30%.

Electrical fast tran-

sient/burst

IEC 61000-4-5

±2 kV for

powersupply

lines

±1 kV for

input/output

lines

±2 kV for

powersupply

lines

±1 kV for

input/output

lines

Mains power quality should be that of a

typical commercial or hospital environ-

ment.

Surge

IEC 61000-4-5 ±1 kV differ-

ential mode

±2 kV com-

mon mode

±1 kV differ-

ential mode

±2 kV com-

mon mode

Mains power quality should be that of a

typical commercial or hospital environ-

ment.

Safety Information

(3)

Voltage dips, short

interruptions and volt-

age variations on

power supply input

lines

IEC 61000-4-11

<5% UT

(>95% dip in

UT) for 0.5

cycle.

40% UT

(60% dip in

UT) for 5

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 0.5

cycle.

40% UT

(60% dip in

UT) for 5

cycles

70% UT

(30% dip in

UT) for 25

cycles

<5% UT

(>95% dip in

UT) for 5 sec.

Mains power quality should be that of a

typical commercial or hospital environ-

ment. If the user of the CXDI-50G requires

continued operation during power mains

interruptions, it is recommended that the

CXDI-50G be powered from an uninter-

ruptible power supply.

Power frequency

(50/60Hz) magnetic

field

IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should

be at levels characteristic of a typical loca-

tion in a typical commercial or hospital

environment.

NOTE: UTis the a.c. mains voltage prior to application of the test level.

Immunity Test IEC 60601

Test Level Compliance

Level Electromagnetic Environment – Guidance

(4)

Safety Information

Immunity Test IEC 60601 Test

Level Compliance

Level Electromagnetic Environment – Guidance

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms

150 kHz to 80

MHz

3 V/m

80 MHz to 2.5

GHz

3 V/m

Portable and mobile RF communications

equipment should be used no closer to

any part of the CXDI-50G, including

cables, than the recommended separation

distance calculated from the equation

applicable to the frequency of the trans-

mitter.

Recommended separations distance

where P is the maximum output power rat-

ing of the transmitter in watts (W) accord-

ing to the transmitter manufacturer and d

is the recommended separation distance

in metres (m).

Field strengths from fixed RF transmitters,

as determined by an electromagnetic site

surveya, should be less than the compli-

ance level in each frequency rangeb.

Interference may occur in the vicinity of

equipment marked with the following sym-

bol:

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, object and people.

aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) tele-

phones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast can-

not 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 CXDI-50G is used exceeds the applicable RF compliance level above,

the CXDI-50G should be observed to verify normal operation. If abnormal performance is observed,

additional measures may be necessary, such as reorienting or relocating the CXDI-50G.

bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

d1.2 P=

d1.2 P80 MHz to 800 MHz=

d2.3 P800MHz to 2.5 GHz=

Safety Information

(5)

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 this product.

Keep this manual for future reference.

Meaning of Caution Signs

WARNING This indicates a potentially hazardous situation which, if not heeded, could

result in death or serious injury to you or others.

CAUTION This indicates hazardous situation which, if not heeded, may result in minor or

moderate injury to you or others, or may result in machine damage.

NOTE This is used to emphasize essential information.

Be sure to read this information to avoid incorrect operation.

Environment of Use and Storage

WARNING

Do not use or store the instrument near any flammable chemicals such as

alcohol, thinner, benzine, etc. Also, this instrument is not a category AP or

APG equipment. If chemicals are spilled or evaporate, it may result in fire or

electric shock through contact with electric parts inside the instruments. Also,

some disinfectants are flammable.

Be sure to take care when using them.

CAUTION

Do not install 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.

- Prone to vibration.

- Insecure place.

- Dusty environment.

- Saline or sulfurous environment.

- High temperature or humidity.

- Freezing or condensation.

Installation Operation

WARNING Do not connect the instrument with anything other than specified.

Otherwise, it may result in fire or electric shock.

(6)

Safety Information

Power Supply

WARNING

Be sure to turn OFF the power of each instrument before connecting or dis-

connecting the cables.

Also, do not handle them with wet hands. Otherwise, you may get an electric

shock that may result in death or serious injury.

WARNING Be sure to hold the plug or connector to disconnect the cable.

If you pull the cable, the core wire may be damaged, resulting in fire or electric

shock.

WARNING

Do not cut or process the cables. Also, do not place anything heavy, including

the instrument on it, step on it, pull it, bend it, or bundle it.

Otherwise, the cable may be damaged, which may result in fire or electric

shock.

WARNING Do not turn ON the system power when condensation is formed on the instru-

ment. Otherwise, it may result in fire or electric shock.

CAUTION Because the instrument’s cable is long, take care so cables do not get tangled

during use. Also, be careful not to get your feet caught in the cable.

Handling

WARNING

Always be sure to keep checking the condition of the system and the patient

to ensure they are normal during the use of the instrument.

If any problem is found, take appropriate measures, such as stopping the

operation of the instrument, as required.

WARNING

Never disassemble or modify the product as it may result in fire or electric

shock. Also, since the instrument incorporates parts that may cause electric

shocks and other hazardous parts, touching them may cause death or serious

injury.

WARNING 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 instru-

ment is used without it being repaired.

WARNING

Wipe the CFRP plate of the sensor unit with ethanol or glutaraldehyde solu-

tion to disinfect it each time a different patient uses the instrument, in order to

prevent infection.

If the optional grid unit is being used, disinfect its surface.

Please consult a specialist for the procedure for disinfection.

CAUTION

Do not spill liquid or chemicals onto the instrument or, in cases where the

patient is injured, allow it to become wet with blood or other body fluids, as

doing so may result in fire or electric shock.

In such situation, protect the instrument with disposable covering as neces-

sary.

CAUTION Turn off the power of each instrument for safety when they are not going to be

used.

Safety Information

(7)

When Problem Occurs

WARNING

Should any of the following occur, immediately turn OFF the power of each

instrument, unplug the power cable from the AC outlet, and contact Canon

representative or distributor.

- When there is smoke, odd smell or abnormal sound.

- When liquid has been spilled into the instrument or a metal object has

entered through an opening.

- When the instrument has been dropped and it is damaged.

Maintenance and Inspection

WARNING For safety reasons, be sure to turn OFF the power of each instrument when

the inspections indicated in this manual are going to be performed.

Otherwise, it may result in electric shock.

WARNING

When the instrument is going to be cleaned, be sure to turn OFF the power of

each instrument, and unplug the power cable from the AC outlet.

Never use benzine, thinner or any other flammable cleaning agents.

Otherwise, fire or electric shock may result.

WARNING

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.

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.

CAUTION For safety reasons, be sure to inspect the instrument before using it.

(8)

Safety Information

Labels and Markings on the Instrument

The CXDI-50G has a few labels and markings on it.

Contents of those and positions where they are attached are indicated below.

Sensor Unit

Front

Rear

100kg

This mark indicates that this is a Type B

Applied Part according to UL2601-1 and

EN60601-1.

This unit can be installed in the patient

environment.

These marks indicate that the instrument

must be handled with care.

Do not jolt or apply excessive load to the

instrument.

Name Label

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