Mitsubishi Electric P-95DW Manuel utilisateur

This digital monochrome printer complies with the requirements of the EC Directive

93/42/EEC.

DIGITAL MONOCHROME PRINTER

MODEL

P95DW

P95DE

OPERATION MANUAL

THIS OPERATION MANUAL IS IMPORTANT

TO YOU.

PLEASE READ IT BEFORE USING YOUR

DIGITAL MONOCHROME PRINTER.

DIGITAL MONOCHROME

PRINTER

FOR THE MODEL P91DW(UB) ONLY

WARNING:

In the USA or Canada, use the AC power cord according to the recommendations as

below, in order to comply with UL60601-1 and CAN/CSA C22.2 No. 601.1.

Case 1. Connect to the 120V receptacle of the room or the host equipment.

The AC power cord should be UL or CSA approved and consist of type SJT,

size 16 or 18AWG, length 2.5m or shorter cord with IEC60320-1/C13 type, 125V

10A or higher rating connector and NEMA 5-15 type, 125V 10A or higher rating,

Hospital Grade plug.

Case 2. Connect to the 230V receptacle of the room or the host equipment.

The AC power cord should be UL or CSA approved and consist of type SJT,

size 16 or 18AWG, length 2.5m or shorter cord with IEC60320-1/C13 type, 250V

10A or higher rating connector and NEMA 6-15 type, 250V 10A or higher rating,

Hospital Grade plug.

CAUTION:

Changes or modifications not expressly approved by the party

responsible for compliance could void the user’s authority to operate the

equipment.

NOTE:

This equipment has been tested and found to comply with the limits for a

Class A digital device, pursuant to Part 15 of the FCC Rules.

These limits are designed to provide reasonable protection against harm-

ful interference when the equipment is operated in a commercial environ-

ment. This equipment generates, uses, and can radiate radio frequency

energy and, if not installed and used in accordance with the instruction

manual, may cause harmful interference to radio communications.

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

interference in which case the user will be required to correct the interfer-

ence at his or her own expense.

Information:

This class A digital apparatus complies with Canadian ICES-003.

"CLASSIFIED BY UNDERWRITERS LABORATORIES INC.®

WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN

ACCORDANCE WITH UL60601-1 AND CAN/CSA C22.2 No. 601.1"

Indications according to IEC60601-1

1. Functions and intended usage of this product

This product receives signals from diagnostic imaging equipment or a personal computer,

and automatically prints and ejects the received image data on the thermal paper.

2. Classiﬁcation of this product

• According to the type of protection against electric shock: Equipment energized from an

external electrical power source, Class I equipment

• According to the degree of protection of the applied part against electric shock: - (No

applied part)

• According to the degree of protection against harmful ingress of water: Ordinary

equipment (Enclosed equipment without protection against ingress of water)

• According to the degree of safety of application in the presence of a ﬂammable anesthetic

mixture with air or with oxygen or nitrous oxide: Equipment not suitable for use in the

presence of a ﬂammable anesthetic mixture with air or with oxygen or nitrous oxide

• According to the mode of operation: Continuous operation with intermittent loading

3. Follow the applicable laws and regulations in your country or region or the hospital rules

when disposing of this product or the accessories or consumables thereof.

DANGER:

EXPLOSION HAZARD.

DO NOT USE IN THE PRESENCE OF FLAMMABLE ANESTHETICS.

The lightning ﬂash with arrowhead symbol, within an equilateral triangle, is

intended to alert the user to the presence of uninsulated "dangerous voltage"

within the product's enclosure that may be of sufﬁcient magnitude to constitute a

risk of electric shock.

The exclamation point within an equilateral triangle is intended to alert the user

to the presence of important operating and maintenance (servicing) instructions

in the literature accompanying the appliance.

The “Caution, hot surface” symbol indicates that the marked item may be hot

and should not be touched.

The “Nonionizing radiation” symbol

The “OFF/ON” symbol indicates connection to or disconnection from the mains,

at least for mains switches.

The “Equipotentiality” symbol identiﬁes the terminals connected each other. The

potential of various parts of equipment or of a system is equalized.

The “Alternating current” symbol indicates that the equipment is suitable for

alternating current only.

RISK OF ELECTRIC SHOCK DO NOT OPEN.

TO REDUCE THE RISK OF ELECTRIC SHOCK, DO NOT REMOVE COVER (OR

BACK).

NO USER-SERVICEABLE PARTS INSIDE. REFER SERVICING TO QUALIFIED

SERVICE PERSONNEL.

CAUTION:

When you dispose of the unit or accessories, you must obey the law in the relative area

or country and/or regulation in the relative hospital.

: Manufactured on : to be combined with date code YYYY-MM

: Manufacturers Identiﬁcation (name address)

: Serial number

: Authorised representative in the European Community

WARNING:

Install and use this appliance in accordance with the operation manual for safety and

EMC (Electromagnetic Compatibility). If it is not installed and used in accordance with

the operation manual, it may cause interference to other equipment and/or other risk.

To prevent ﬁre or shock hazard, do not expose this appliance to rain or moisture.

This appliance must be earthed.

In Europe, use the AC power cord according to the recommendations as below.

Connect to the 230 V receptacle of the room or the host equipment.

The AC power cord should be VDE approved and consist of core size 0.75 mm2or

bigger, length 2.5 m or shorter cord with IEC60320-1/C13 type, 250 V 10 A or higher

rating connector and CEE(7)VII type, 250 V 10 A or higher rating plug.

Use the USB cable according to the recommendations as below, in order to comply with

EN60601-1-2.

The USB cable with appropriate plug should be 2 m long or shorter, comply with USB 2.0

standard High speed requirements and USB IF (USB Implementers Forum) approved.

This product is to be employed with medical equipment, just for reference purpose, not

for medical diagnostic purpose.

Your MITSUBISHI ELECTRIC product is designed and manufactured with high quality

materials and components which can be recycled and reused.

This symbol means that electrical and electronic equipment, at their end-of-life, should

be disposed of separately from your household waste.

Please, dispose of this equipment at your local community waste collection/recycling

centre.

In the European Union there are separate collection systems for used electrical and

electronic product.

Please, help us to conserve the environment we live in!

Note: This symbol mark is for EU countries only.

This symbol mark is according to the directive 2002/96/EC Article

10 Information for users and Annex IV.

WARNING:

The socket outlet shall be installed near the equipment and shall be easily ac-

cessible.

INSTRUCTIONS FOR MEDICAL USE

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 AC-

COMPANYING DOCUMENTS.

Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL

EQUIPMENT.

Technical description

List of all cables and maximum length of the cable and other ACCECCORIES

AC power cord

USB cable

Thermal paper

Maximum length

2.5 m

2 m

Reference page in this operation manual

This page, the previous pages for safety and page 25

for accessories

This page and the previous pages for safety

Page 3 for thermal paper, Page 25 for accessories

WARNING:

The use of ACCESSORIES and cables other than those speciﬁed, with the exception of ca-

bles sold by the manufacturer of the Model P95DW/P95DE as replacement parts for internal

components, may result in increased EMISSIONS or decreased IMMUNITY of the Model

P95DW/P95DE.

WARNING:

The Model P95DW/P95DE should not be used adjacent to or stacked with other equipment

and that if adjacent or stacked use is necessary, the Model P95DW/P95DE should be ob-

served to verify normal operation in the conﬁguration in which it will be used.

Guidance and manufacturer's declaration - electromagnetic emissions

The Model P95DW/P95DE is intended for use in the electromagnetic environment specified below.

The customer or user of the Model P95DW/P95DE should assure that it is used in such an

environment.

Emissions test

RF emissions

CISPR 11/EN 55011

RF emissions

CISPR 11/EN 55011

Harmonic emissions

IEC/EN 61000-3-2

Voltage fluctuations/

flicker emissions

IEC/EN 61000-3-3

Compliance

Group 1

Class B

Class A

Complies

Electromagnetic environment - guidance

The Model P95DW/P95DE uses RF energy only for its

internal function. Therefore, its RF emissions are very

low and are not likely to cause interference in nearby

electronic equipment.

The Model P95DW/P95DE is 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.

Guidance and manufacturer's declaration - electromagnetic immunity

The Model P95DW/P95DE is intended for use in the electromagnetic environment specified below.

The customer or user of the Model P95DW/P95DE should assure that it is used in such an

environment.

Immunity test

Electrostatic

discharge (ESD)

IEC/EN 61000-4-2

Electrical fast

transient/burst

IEC/EN 61000-4-4

Surge

IEC/EN 61000-4-5

Voltage dips, short

interruptions and

voltage variations

on power supply

input lines

IEC/EN 61000-4-11

Power frequency

(50/60 Hz)

magnetic field

IEC/EN 61000-4-8

IEC/EN 60601

test level

±6 kV contact

±8 kV air

±2 kV for power

supply lines

±1 kV for input

/output lines

±1 kV line(s) to

line(s)

±2 kV line(s) to

earth

< 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.

3 A/m

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 Model

P95DW/P95DE requires continued

operation during power mains

interruptions, it is recommended that the

Model P95DW/P95DE 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.

Compliance

level

±6 kV contact

±8 kV air

±2 kV for power

supply lines

±1 kV for input

/output lines

±1 kV line(s) to

line(s)

±2 kV line(s) to

earth

< 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.

3 A/m

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

Guidance and manufacturer's declaration - electromagnetic immunity

The Model P95DW/P95DE is intended for use in the electromagnetic environment specified below.

The customer or user of the Model P95DW/P95DE should assure that it is used in such an

environment.

Immunity test

Conducted RF

IEC/EN 61000-4-6

Radiated RF

IEC/EN 61000-4-3

IEC/EN 60601

test level

3 Vrms

150 kHz to 80

MHz

3 V/m

80 MHz to 2.5

GHz

Electromagnetic environment - guidance

Portable and mobile RF communications

equipment should be used no closer to

any part of the Model P95DW/P95DE,

including cables, than the recommended

separation distance calculated from the

equation applicable to the frequency of

the transmitter.

Recommended separation distance

d=1.2√P

d=1.2√P 80 MHz to 800 MHz

d=2.3√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 survey,ashould be

less than the compliance level in each

frequency range.b

Interference may occur in the vicinity of

equipment marked with the following

symbol:

Compliance

level

3 Vrms

3 V/m

NOTE1. At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE2. These guidelines may not apply in all situations. Electromagnetic propagation is

affected by absorption and reflection from structures, objects and people.

aField 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 Model P95DW/P95DE

is used exceeds the applicable RF compliance level above, the Model P95DW/P95DE

should be observed to verify normal operation. If abnormal performance is observed,

additional measures may be necessary, such as reorienting or relocating the Model

P95DW/P95DE.

bOver 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 Model P95DW/P95DE

The Model P95DW/P95DE is intended for use in an electromagnetic environment in which radiated

RF disturbances are controlled. The customer or the user of the Model P95DW/P95DE can help

prevent electromagnetic interference by maintaining a minimum distance between portable and

mobile RF communications equipment (transmitters) and the Model P95DW/P95DE as

recommended below, according to the maximum output power of the communications equipment.

Rated maximum output

power of transmitter

0.01

0.1

100

150 kHz to 80 MHz

d=1.2√P

0.12

0.38

1.2

3.8

80 MHz to 800 MHz

d=1.2√P

0.12

0.38

1.2

3.8

800 MHz to 2.5 GHz

d=2.3√P

0.23

0.73

2.3

7.3

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.

NOTE1. At 80 MHz and 800 MHz, the separation distance for higher frequency range applies.

NOTE2. 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

Safety Notices for use in combination with other devices

1. All the equipments connected to this unit shall be certiﬁed according to Standard

IEC60601-1, IEC60950-1, IEC60065 or other IEC/ISO Standards applicable to the equip-

ments.

2. When this unit is used together with other equipment in the patient area*, the equip-

ment shall be either powered by an isolation transformer or connected via an additional

protective earth terminal to system ground unless it is certiﬁed according to Standard

IEC60601-1.

* Patient Area

R1.5m

3. The leakage current could increase when connected to other equipment.

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