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Drystar 5500
User manual Software 2.x
This product is registered in China under the registration number:
For more information on Agfa products and Agfa HealthCare products, 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, with respect to the accuracy, completeness or usefulness of the information contained in this document and specifically disclaims warranties of suitability for any particular purpose. Agfa-Gevaert N.V. shall under no circumstances be liable for any damage arising from the use or inability to use any information, apparatus, method or 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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Table of contents |
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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 operation (key-operator mode)................................... |
47 |
Overview of key-operator functions ................................................................ |
48 |
Preventive maintenance schedule .................................................................. |
49 |
Cleaning the exterior ...................................................................................... |
50 |
Cleaning the printhead resistor line ................................................................ |
51 |
Troubleshooting checklist ............................................................................... |
54 |
Appendix A: Equipment information sheet.................................................... |
55 |
Specifications................................................................................................. |
56 |
Options and accessories ................................................................................ |
59 |
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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 Drystar 5500
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 Drystar 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 with 2 input trays. Both input trays can use multiple format (8x10” up to 14x17”) films.
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#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 diagnostic imaging systems, including the ADC Compact and ADC Quality 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).
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Introducing the Drystar 5500 |
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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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 warning, indicating that the Drystar 5500 manuals should be consulted before making any connections to other equipment. The use of accessory equipment not complying with the equivalent safety requirements of this printer may lead to a reduced 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,
• Evidence that the safety certification of the accessory equipment has been performed in accordance with the appropriate IEC 601-1 and IEC 601-1-2 harmonized national standard.
In addition all configurations must comply with the medical electrical 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 Drystar 5500 complies with the limits for type B equipment.
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Supplementary protective earth connector:
Provides a connection between the Drystar 5500 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 earth (ground):
Provides a connection between the printer and the protective earth of the mains. Do not remove this connection, because this will have 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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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.
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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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Safety compliance
EMC issues
•USA: 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 Reference 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 its own expense.
If required, contact your local service organization.
•Canada: This class A digital apparatus meets all requirements of the Canadian Interference-Causing Equipment Regulations.
•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-M90 of the Canadian Standards Association
•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 60601-1-2:2001
•GB4943-2001
•GB9254-1998
•GB17625.1-2003
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Introducing the Drystar 5500 |
Label
The Drystar 5500 carries the CE, TÜV and the CUL label.
To find the label location
1 Open the front door.
2 The label is visible inside the printer:
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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 Drystar 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).
•Product User Authentication: 'User Authentication' 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).
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Node authentication, certificates and Certification Authority
Each device - connected to a network - will receive a unique identifier: the X.509 certificate, a digital passport. Any device on the network is only allowed 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 certificates of all peer devices with which communication is authorized, i.e. creates the list of ‘communication allowed’ device certificates.
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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 hardcopies;
•Loading consumables;
•Ensuring normal operation 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-operator mode
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 (keyoperator mode)’.
Service mode
The service mode functions are reserved for trained service personnel. The service mode is password protected.
Specialist 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.
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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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