THIS OPERATION MANUAL IS IMPORTANT
TO YOU.
PLEASE READ IT BEFORE USING YOUR
DIGITAL MONOCHROME PRINTER.
DIGITAL MONOCHROME
PRINTER
This digital monochrome printer complies with the requirements of the EC Directive
93/42/EEC.
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 harmful interference when the equipment is operated in a commercial environment. 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 interference 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. Classifi cation 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 fl ammable anesthetic
mixture with air or with oxygen or nitrous oxide: Equipment not suitable for use in the
presence of a fl ammable 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.
CAUTION:
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.
The lightning fl ash 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 suffi cient 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 identifi es 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.
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 Identifi cation (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 fi re 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 mm
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.
2
or
WARNING:
The socket outlet shall be installed near the equipment and shall be easily accessible.
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.
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!
INSTRUCTIONS FOR MEDICAL USE
<according to the Medical Safety/EMC standard IEC/EN 60601-1-2>
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.
Technical description
List of all cables and maximum length of the cable and other ACCECCORIES
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
AC power cord
USB cable
Thermal paper
Maximum length
2.5 m
2 m
WARNING:
The use of ACCESSORIES and cables other than those specifi ed, 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 observed to verify normal operation in the confi guration 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
Compliance
Group 1
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
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
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
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
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.
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
< 5% U
T
(> 95% dip in UT)
for 0.5 cycle
40% U
T
(60% dip in UT)
for 5 cycles
70% U
T
(30% dip in UT)
for 25 cycles
< 5% U
T
(> 95% dip in UT)
for 5 sec.
3 A/m
< 5% U
T
(> 95% dip in UT)
for 0.5 cycle
40% U
T
(60% dip in UT)
for 5 cycles
70% U
T
(30% dip in UT)
for 25 cycles
< 5% U
T
(> 95% dip in UT)
for 5 sec.
3 A/m
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.
NOTE: UT is 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
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 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,
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:
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.
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 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.
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 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
W
0.01
0.1
1
10
100
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
150 kHz to 80 MHz
d=1.2√P
0.12
0.38
1.2
3.8
12
m
80 MHz to 800 MHz
d=1.2√P
0.12
0.38
1.2
3.8
12
800 MHz to 2.5 GHz
d=2.3√P
0.23
0.73
2.3
7.3
23
Safety Notices for use in combination with other devices
1. All the equipments connected to this unit shall be certifi ed according to Standard
IEC60601-1, IEC60950-1, IEC60065 or other IEC/ISO Standards applicable to the equipments.
2. When this unit is used together with other equipment in the patient area*, the equipment shall be either powered by an isolation transformer or connected via an additional
protective earth terminal to system ground unless it is certifi ed according to Standard
IEC60601-1.
* Patient Area
R1.5m
3. The leakage current could increase when connected to other equipment.
1
Front Panel .......................................................................................... 7