Agfa Drystar 5500 User Manual
Drystar 5500
User manual
Software 2.x
This product i s registered in China under the registrat ion number:
For more information on Agfa products and Agfa HealthCare produ cts, please visit www.agfa.com, your
Point of Knowledge.
© Agfa-Gevaert N.V. 2004.
No parts of this document may be reproduced, copied, adapted or transmitted in any form or by any means
without the written permission of Agfa-Gevaert N.V.
Agfa-Gevaert N.V. makes no warranties or representation, expressed or implied, wi th respect to the accu-
racy, completeness or usefulne ss of the informa tion contained i n this docu ment and spec ifically di sclaims
warranties of suitability for any particular purpose. Agfa-Gevaert N.V. shall under no circumstances be liable
for any damage arising f rom the u se or inab ility to u se any info rmation , apparatus , me thod o r process disclosed in this document.
Agfa-Gevaert N.V. reserves the right to make changes to this document without prior notice.
Agfa-Gevaert N.V., Septestraat 27, B-2640 Mortsel, Belgium.
Drystar 5500 is a trademark of Agfa-Gevaert N.V., Belgium.
Agfa and Agfa-Rhombus are trademarks of Agfa-Gevaert AG, Germany.
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2901B EN 20040413
Table of contents
Chapter 1: Introducing the Drystar 5500.......................................................... 5
Drystar 5500 features.......................................................................................6
Safety precautions ...........................................................................................8
Security precautions....................................................................................... 12
Safety compliance..........................................................................................13
Privacy and security.......................................................................................15
Operating modes ...........................................................................................17
Control modes (local and remote)................................................................... 19
The user interface..........................................................................................20
Switching on the Drystar 5500........................................................................26
Switching off the Drystar 5500........................................................................28
Chapter 2: Basic operation (operator mode).................................................29
Overview of operator functions....................................................................... 30
Managing the print queue...............................................................................31
Assigning emergency priority..........................................................................33
Deleting print jobs ..........................................................................................34
About Drystar 5500 consumables...................................................................36
Loading films.................................................................................................. 38
Chapter 3: Advanced operati on (key-operator mode)...................................47
Overview of key-operator functions ................................................................48
Prevent ive ma inte nan ce sche du le..................................................................49
Cleaning the exterior......................................................................................50
Cleaning the printhead resistor line ................................................................ 51
Troubleshooting checklist...............................................................................54
Appendix A: Equipment informati on sheet....................................................55
Specifications.................................................................................................56
Options and accessories ................................................................................59
2901B EN 20040413
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2901B EN 20040413
Chapter
1
Introducing the Drystar 5500
This chapter introduces the Drystar 5500 to the user and
draws attention to important safety precautions.
! Drystar 5500 features
! Safety precautions
! Security precautions
! Safety compliance
! Privacy and security
! Operating modes
! Control modes (local and remote)
! The user interface
! Switching on the Drystar 5500
! Switching off the Drystar5500
Drystar 5500 features
The Drystar 5500 is a dry digital printer for producing diagnostic images. It
can print multiple format (8x10” up to 14x17”) blue-based and clear-based
film and offers crisp, dense grayscale images. The Drystar 5500 is designed
for high-throughput and as a central printer.
" The Drystar 5500 is a Dicom-only network printer.
The Drysta r 5500 offers the following features:
# Dry technology for printing diagnostic quality hard copies in full daylight offers
important advantages: no chemistry, no wet processing, simple cleaning
procedures, no time-consuming adjustments, no darkroom and no chemical
disposal costs. The consumables can be loaded in full daylight.
# With its compact design, the Drystar 5500 needs little work space and allows
easy customer access. Maintenance and service activities are reduced to the
minimum.
# The direct thermal printing system provides grayscale images with laser-like
quality: 508 dots per inch resolution, each pixel with 12 bit contrast resolution
and an optical density ranging from 0.2 up to 3.1 (if an X-Rite 310
densitometer is used).
# The built-in image spooling on hard disk assures a high throughput. Printing
time is kept to a minimum.
# Multiple film formats (8x10”, 10x12”, 11x14”, 14x14”, and 14x17”) can be
used. Any combination of two film formats can be used “online”. Both input
trays can be adjusted for all film formats.
# The input trays of the Drystar 5500 are equipped with an RF-tag reader,
which automatically traces the films used in the printer and protects the
printer when detecting non-identified media.
# Number of input trays.
The Drystar 5500 is delivered w ith 2 input tray s. Both input tr ays can use m ultiple
format (8x10” up to 14x1 7”) film s.
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Introducing the Drystar 5500
2901B EN 20040413
# Number of output trays
The Drystar 5500 is delivered with 4 output trays, which can be assigned to
modalities in any combination.
Network features
# The modular design offers optimal application to your specific networking
requirements.
In a network configuration, the Drystar 5500 is fully compatible with Agfa’s
diagnost ic imagin g systems , includin g the ADC Co mpact and ADC Quali ty System
software, the Paxport and the entire line of Impax Review Systems, Storage
Stations and Transmitting Stations.
# The functionality of the Drystar 5500 is completely controlled via the network.
# You can control the working of the Drystar 5500 via the local keypad or via a
remote PC featuring a browser functionality.
Customizable features
# Number of output trays.
The Drystar 5500 is delivered with 4 output trays and a sorter.
# Consumables.
The Drystar 5500 can handle Drystar DT2 B and Drystar DT2 C consumables, both
in multiple formats (8x10” up to 14x17”).
Software license information
# The Drystar 5500 printer uses software developed by the Apache Software
Foundation (http://www.apache.org/licenses/LICENSE).
2901B EN 20040413 Introducing the Drystar5500
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Safety precautions
" The Drystar 5500 must only be operated according to its specifications
and its intended use. Any operation not corresponding to the
specifications or intended use may result in hazards, which in turn may
lead to serious injuries or fatal accidents (for example electric shocks).
AGFA positively will not assume any liability in these cases.
" All images created using any image technology can show artifacts which
could be mixed up with diagnostic relevant information. If there is any
doubt that the diagnostic information could not be absolutely true,
additional investigations must be performed to get a clear diagnostic.
When operating or maintaining the Drystar 5500, always observe the
following safety guidelines:
• Have electrical or mechanical defects repaired by skilled personnel only!
• Do not override or disconnect the integrated safety features.
• Ventilation openings may not be covered.
• Always switch off the Drystar 5500 and disconnect the power cord from the
outlet before carrying out any maintenance work.
" Film jam removal or Cleaning the printer thermal head can be done
without switching the power off. Nevertheless, care should be taken and
the following instructions should be respected:
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Introducing the Drystar 5500
2901B EN 20040413
Always take into account the markings provided on the inside and outside of
the printer. A brief overview of these markings and their meaning is given
below.
Safety w arning, indica ting th at the Drystar 550 0 man uals sh ould b e
consulted before making any connectio ns to other equ ipment. The
use of accessory equipment not complying with the equivalent
safety requirements of this printer may lead to a reduc ed level of
safety of the resulting system. Consideration relating to the choice of
accessory equipment shall include:
• Use of the accessory equipment in the patient vicinity,
• Evidenc e that the safe ty cert ifica tion of the access ory equipm en t
has been performed in accordance with the appropriate IEC 601-1
and IEC 601-1-2 harmonized national standard.
In addition all c onf igur atio ns m ust com ply with the med ica l elec tric al
systems standard IEC 601-1-2. The party that makes the
connections acts as system configurator and is responsible for
complying with the systems standard.
If required contact your local service organization.
Caution hot:
Keep hands clear from the thermal printhead.
In order to reduce the risk of electric shock, do not remove any
covers.
Type B equipment:
Indicates that the Dry star 5500 c omplies with th e limits for typ e B
equipment.
2901B EN 20040413 Introducing the Drystar5500
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Supplementary protective earth connector:
Provides a conn ection between the Drystar 550 0 and the potential
equalization busbar of the electrical system as found in medical
environments. This plug should never be unplugged before the
power is turned off and the power plug has been removed.
Intergrounding connector:
Provides a connection between the printer and other equipment
which might exhibit minor ground potential differences. These
differences may degrade the quality of communication between
different equipment. Never remove connections to this terminal.
Protective eart h (grou nd) :
Provides a c onnection b etween the printer and the protectiv e earth
of the ma ins. Do no t r emo ve thi s co nn ecti on, be cau se this wi ll h ave
a negative influence on the leakage current.
Power Button:
Note that the power cord has to be disconnected from the wall outlet
in order to disconnect the unit entirely from the mains.
Precautions for use in USA only:
Make sure that the circuit is single-phase center-tapped, if the printer
is connected to a 240 V/60 Hz source instead of a 120 V/60 Hz
source.
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Introducing the Drystar 5500
2901B EN 20040413
Transport after installation
Before moving the printer, always switch off the machine. The user has to be
very cautious concerning stability, when moving the printer. When doing this,
he has to take into account the condition and the structure of the subsoil,
obstructions and slopes. Also the user has to make sure that the brakes are
loose. The appliance can only be transported with all covers closed. The
appliance may not be transported continuously from one location to the other.
To prevent injuries, lock the brakes when the Drystar 5500 is in place at
the right location.
Waste disposal and environmental regulations
In most countries Drystar film is considered industrial waste and
consequently it is not allowed to dispose of it as household waste. Please
consult your local waste disposal regulations. Agfa recommends to have
waste Drystar film hauled away by a licensed company.
After its life span, do not dispose of the Drystar 5500 without consideration of
local waste disposal regulations. Please consult your local service
organization.
2901B EN 20040413 Introducing the Drystar5500
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Security precautions
CAUTION: U.S. Law restricts this device to sale to or on the order of a
licensed physician.
Printed images should be treated as patient records and should only be
viewed by authorized personnel.
It is good practice not to delete images from the modality, until they are
correctly printed.
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Introducing the Drystar 5500
2901B EN 20040413
Safety compliance
EMC issues
USA: T his equ ipmen t has b een te sted an d foun d to c omply with th e limits f or 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
equipm ent is oper ate d in a co mm erci al env iron me nt. Th is eq uip men t gen era tes ,
uses, an d can radiate ra dio frequency e nergy and, if no t installed and us ed in
accordance with the Reference manual, may cause harmful interference to radio
communications. Operation of this equipment in a residential area is likely to
cause h arm ful inte rfer enc e in wh ich cas e th e u ser will be requ ired to cor rect the
interference at its own expense.
If required, contact your local service organization.
• Can ada: This c lass A digi tal appara tus m eets a ll requ iremen ts of t he Ca nadian
Interfere nc e-C aus ing Equ ipm ent Regula tio ns.
• EC: This is a class A product. In a domestic environment this product may cause
radio interference in which case the user may be required to take adequate
measures.
Compliances
This equipment complies with:
• the Medical Devices Directive 93/42/EEC
• the standards UL2601-1 of Underwriters Laboratories
• CSA 22.2 No. 601 .1-M 90 of the Canad ian Standards Asso cia tion
• FDA 510k
• FDA Part 820 Good manufacturing Practice for Medical devices
• IEC 601-1 and IEC 601-1-2
• EN 60601-1:1990 + A1:1993 + A2:1995
• EN 606 01- 1-2: 200 1
• GB4943-2001
• GB9254-1998
• GB17625.1-2003
2901B EN 20040413 Introducing the Drystar5500
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Label
The Drystar 5500 carries the CE, TÜV and the CUL label.
To find the label location
Open the front door.
1
2 The label is visible inside the printer:
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Introducing the Drystar 5500
2901B EN 20040413
Privacy and security
Within the healthcare industry, several standardization efforts are ongoing as
a response to Privacy and Security legislation and regulations. The purpose
of this standardization for hospitals and vendors is to enable information
sharing, interoperability and to support the workflow of hospitals in a multiple
vendor environment.
In order to allow hospitals to comply with HIPAA regulations (Health
Insurance Portability and Accountability Act) and to meet the IHE standards
(Integrated Healthcare Enterprise) some security features are included in the
user interface of the Drystar 5500 (available via the web pages only: under
‘Security tools’. Refer to ‘Controlling the Drystar 5500 via a remote PC (with
browser)’ on page 141 of the D rystar 5500 Reference manual):
• Product Authentication: HIPAA supported products that communicate with
DICOM use the Transport Layer Security (TLS) protocol. The TLS protocol uses
public key certificates for client and server authentication (X.509).
• Product Accountability: HIPAA supported products require some level of user
and system activity to be recorded. As a consequence of these actions, audit
records are be sent to and observed at an Audit Record Repository (ARR).
• Prod uct User Authentic ation: 'User Authentica tion' of HIPAA products involves
password protection for access to User, Key operator, Service Security/
Administrator and other user interfaces that allow access to protected health
information (PHI). These interfaces include all user keypads, front panels
displays and network connections.
The last two functions are available when access to the Administrator is
granted (i.e. when the Administrator password has been correctly entered).
2901B EN 20040413 Introducing the Drystar5500
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Node authen ticat ion, cert ificat es and Cer tifica tio n Auth ority
Each device - connected to a network - will receive a unique identifier: the
X.509 certificate, a digital pass port. Any devi ce on the network is only allow ed
to communicate with another node of which it is holding the certificate in a
‘communication allowed’ table.
A Certification Authority (CA) is responsible for creating a certificate. The CA
can be the hospital, Agfa or a third party.
This CA distributes the certificate to the hospital security responsible or
service technician, who for his part:
• Imports the device certificate, created by the CA.
Imports the c erti fica tes o f al l pe er de vic es w ith whic h c omm un icat ion is au tho rize d,
i.e. creates the list of ‘communication allowed’ device certificates.
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Introducing the Drystar 5500
2901B EN 20040413
Operating modes
The Drystar 5500 can be operated in five modes: operator mode, keyoperator mode, service mode, specialist mode, and administrator mode.
Operator mode
The operator mode groups all basic functions which are aimed at
radiographers without special technical skills:
• Producing diagnostic usable hardcop ies;
• Loading con suma bl es;
• Ensuring norm al operat ion of the printer.
All functions of the operator mode are described in both User and Reference
manuals. Refer to Chapter 2, ‘Basic operation (operator mode)’.
Key-oper ator mod e
The key-operator mode groups advanced functions which are aimed at
technically skilled operators such as X-ray operators, network managers and
service and hospital technicians.
The key-operator mode can be accessed via the Key-operator key on the
keypad and is menu-driven. The key-operator functions are described in the
Reference manual only. Refer to Chapter 3, ‘Advanced operation (key-
operator mode)’.
Service mode
The service mode functions are reserved for trained service personnel. The
service mode is password protected.
Speciali st mode
The specialist mode functions are reserved for trained service personnel of
the Agfa Customer Support Center. The specialist mode is password
protected and is only accessible by browser via a remote PC.
2901B EN 20040413 Introducing the Drystar5500
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Administrator mode
The Administrator mode functions are reserved for the System Administrator.
The Administrator mode is password protected and is only accessible by
browser via a remote PC. Refer to ‘Privacy and security’ on page 15.
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Introducing the Drystar 5500
2901B EN 20040413
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