Microtek, ScanMaker, ArtixScan, ScanWizard and ColoRescue are trademarks or
registered trademarks of Microtek International, Inc. All other trademarks or
registered trademarks are the property of their respective holders. Specifications,
software and hardware bundles are subject to change without notice. Not
responsible for typographical errors.
Disclaimer
The contents of this manual have been checked carefully for accuracy, and every
effort has been made to ensure that there are no errors. However, Microtek makes
no guarantee as to the accuracy of the contents of this document and reserves the
right to make changes to the contents without prior warning.
I49-004741 B1
September 2013
Microtek International, Inc.
6, Industry East Road 3, Science Based Industrial Park, Hsinchu, Taiwan
Tel: 886-3-5772155, Fax: 886-3-5772598, http://www.microtek.com
2 Medi-2200 Plus User's Manual
Microtek International, Inc.
No. 6, Industry East Road 3,
Science-Based Industrial Park,
Hsinchu, Taiwan
This equipment (Model: MMS-9600TFU2L) has been tested and found to comply
with the limits for a Class B digital device, pursuant to Part 15 of the FCC rules.
These limits are designed to provide reasonable protection against harmful
interference in a residential installation. This equipment generates, uses and can
radiate radio frequency energy and, if not installed and used in accordance with
the instructions, may cause harmful interference to radio communications.
However, there is no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference to radio or
television reception, 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 antenna.
•Increase the separation between the equipment and receiver.
•Connect the equipment into an outlet on a circuit different from that to which
the receiver is connected.
•Consult the dealer or an experienced radio/TV technician for help.
Note: A shielded Hi-Speed USB interface cable with ferrite core installed on the
film digitizer connector end must be used with this equipment.
Caution: Changes or modifications not expressly approved by the manufacturer
responsible for compliance could void the user's authority to operate the
equipment.
This device complies with Part 15 of the FCC Rules. Operation is subject to the
following two conditions: (1) This device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that
may cause undesired operation.
Medi-2200 Plus User's Manual 3
CE 0120 Compliant Device
CE Compliance Statement
This device complies with CE Certification pursuant to
EN 55011:2007+A2:2007
EN 60601-1-2:2007
WEEE Compliance Statement
Microtek International, Inc. operates under full compliance with the WEEE
Directive. Among the requirements of the Directive are the marking of any
applicable equipment placed in the EU market with the WEEE symbol, a crossed
out wheeled bin as shown at left; demonstration of the implementation of a takeback program; and meeting recycling targets.
ISO Compliance Statement
Comply with the requirements of the international standard ISO 9001:2000 and
ISO 13485:2003
4 Medi-2200 Plus User's Manual
Guidance and Manufacturer's Declaration
for EMC Directive
Medi-2200 Plus User's Manual 5
CE Declaration of Conformity (CE DoC)
6 Medi-2200 Plus User's Manual
Safety Precautions
Before using your digitizer, read the following safety guides carefully, which detail
the proper operation of the digitizer and its accessories to prevent injuries or
damage to users or equipment.
Meanings of Symbol Signs
CAUTION
This indicates hazardous situation which, if not payed
attention, could result injury or damage to users or
equipment.
WARNING
Follow operating instructions or Consult instructions for use
STAND-BY
DIRECT CURRENT
This indicates hazardous situation which, if not payed
attention, could result serious injury or death to users.
Power Supply:
•Only use with adapter MAGIC POWER TECHNOLOGY CO., LTD MPM-X60-
15.
•Grounding reliability can only be achieved when the equipment is connected
to an equivalent receptacle marked "Hospital Only" or "Hospital Grade".
•Do not modify this equipment without authorization of the manufacturer.
•To avoid risk of electric shock, this equipment must only be connected to a
supply mains with protective earth.
•This adapter MAGIC POWER TECHNOLOGY CO., LTD MPM-X60-15 is a
forming part of the medical device.
Medi-2200 Plus User's Manual 7
•Accessory equipment connected to the analog and digital interfaces must be
in compliance with the respective nationally harmonized IEC standards (i.e.
IEC 60950 for data processing equipment, IEC 60065 for video equipment,
IEC 61010-1 for laboratory equipment, and IEC 60601-1 for medical
equipment.) Furthermore all configurations shall comply with the system
standard IEC 60601-1-1. Anyone who connects additional equipment to the
signal input part or signal output part is configuring a medical system, and is
therefore, responsible that the system complies with the requirements of the
system standard IEC 60601-1-1. The unit is for exclusive interconnection
with IEC 60601-1 certified equipment in the patient environment and IEC
60XXX certified equipment out-side of the patient environment. If in doubt,
consult the technical services department or your local representative.
•Users must not allow SIP/SOPs and the patient to come into contact at the
same time.
•Ensure to turn off the power of each device before connecting or
disconnecting the cables.
•Insert the plug completely into the outlet, as a loose connection may cause
arcing and result in fire.
•Ensure to hold the plug or connector to disconnect the cable; otherwise, if
you pull the cable only, it may damage the core wire and result in fire or
electric shock.
•Place and route the power supply cord such that it is not likely to be walked
on or pinched by items placed upon or against them, paying particular
attention to the cord near the power plugs, convenience receptacles, and at
the point where it exits from the outlet.
•When the digitizer is left unattended and unused for long periods of time,
unplug it from the wall outlet.
Moving and Storing the Film Digitizer:
•Always ensure that the digitizer is stored properly before shipping or moving
it. Quick stops, excessive force, and uneven surfaces may cause the product
to overturn when moving.
•Do not hit or drop the digitizer. The digitizer may be damaged if it receives a
strong jolt, which may result in fire or electric shock if the digitizer is used
without being repaired.
•Do not place the digitizer on any slippery, slanted, or unstable surface. The
product may slide or fall, causing serious injury to people as well as serious
damage to the product.
•Do not use the digitizer near water. Never spill liquid of any kinds on the
product, or it may result in electric shock or other hazards.
8 Medi-2200 Plus User's Manual
•This digitizer should be situated away from heat sources such as radiators,
heat registers, stoves, or other products (including amplifiers) that produce
heat.
•Do not store the digitizer in which it may be exposed to direct sunlight.
Using the Digitizer
•Before using the digitizer, make sure the area of the glass surface is clear from
obstacles.
•The digitizer is only designed and used for digitizing mammography films or
reflective materials. Do not attend to use it for other purposes.
Maintenance and Service:
•When the digitizer is going to be cleaned, ensure to turn off the power of each
device and unplug the power cable from the AC outlet.
•When you need a repair service, unplug the digitizer from the power outlet
and consult qualified service personnel.
•When replacement parts are required, use replacement parts that are specified
by the manufacturer or have the same characteristics as the original parts.
•For safety reasons, ensure to inspect the device before using it. In addition,
carrying out a regular inspection at least once a year.
Medi-2200 Plus User's Manual 9
Labels and Markings
On The Device
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Microtek International, Inc.
No. 6, Industry East Road 3,
Science-Based Industrial Park,
Hsinchu Taiwan,
I47-0
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D-47877 Willich, Germany
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I47-011084, A
TFDA label
(for Taiwan shipping only)
CE 0120 label
10 Medi-2200 Plus User's Manual
Microtek International, Inc.
No. 6, Industry East Road 3,
Science-Based Industrial Park,
Hsinchu, Taiwan