service dxm

Document Status: Approved Livelink ID: 18065961 Version: 16

HEALTHCAREImaging Services

Service Plan

DOCUMENT CONTROL NOTE:The controlled version of this document resides on MedNet. Any printed copy of this document is uncontrolled.

Agfa HealthCare CompanyConfidential

Document Node ID: 18065961 serviceplan_e_template_v05

Copyright 2011 Agfa HealthCare N.V.

DX-G / DX-M (DICOM: NIM_2000 or higher)

Version 2.3January 2012


Service Plan DX-G / DX-M (DICOM: NIM_2000 or higher)


Page 2 of 51 Agfa HealthCare Company ConfidentialVersion 2.3 Document Node ID: 18065961

TABLE OF CONTENTS

1 Introduction .......................................................................................... 3

2 Summary of Service Plan.................................................................... 4

3 Product Description............................................................................. 5

4 Product Marketing Strategy.............................................................. 14

5 Service Strategy................................................................................. 15

6 Training ............................................................................................... 30

7 Documentation & Software............................................................... 32

8 Service Agreements .......................................................................... 34

9 APPENDIX A Technical Specifications......................................... 35

10 APPENDIX B Spare Parts Listings................................................ 37

11 APPENDIX C Statements of Work................................................. 38

12 Abbreviations ..................................................................................... 49


DX-G / DX-M (DICOM: NIM_2000 or higher) Service Plan


Agfa HealthCare Company Confidential Page 3 of 51Document Node ID: 18065961 Version 2.3

1 Introduction

The purpose of the Service Plan is to inform the Service organization about the service strategy for a new globally released standard solution or product. The Service Plan is a central repository for all service relevant information related to a product or solution. This means that this document provides global information about serviceability at a solution level that can be used by a Region / Country as part of the Regional / Country Launch Project Plan to plan services launch activities for globally released standard solutions or products.

1.1 Changes (Revision History)

Version Changes Date Author Approver

Version 1.0 Initial version 09-2009 C. Steiner See RACI table*

Version 1.1 Training strategy updated 12-2009 C. Steiner See RACI table*

Version 2.0Update to include DX-M

Training strategy with / without WBT digitizer implemented

04-2010 C. Steiner See RACI table*

Version 2.1 Only DICOM version considered 07-2010 C. Steiner See RACI table*

Version 2.2 DX-M mobile includedTraining path updated 03-2011 C. SteinerSee RACI

table*

Version 2.3DX-M technical data corrected

Not working links correctedChapter 5.8.2 Spare Parts updated

01-2012 C. Steiner See RACI table*

Additional front page with RACI table is available on Livelink only.

1.2 References

Title Reference

Service Plan NX HealthCare Library / CR Workstation Software

Service Plan CR Mammo Solution based on DX-M

HealthCare Library (Extranet Link / Intranet Link)

The Field Service ABCs HealthCare Library (Extranet Link / Intranet Link)





2 Summary of Service Plan

Edition 2 of this Serviceplan covers the DX-G / DX-M digitizers in the DICOM version, e.g. software version NIM_2000 or higher.

Edition 1 of the Serviceplan covers DX-G digitizer in the TWAIN version, e.g. software version is below NIM_2000

The DX-G / DX-M digitizer is part of a CR system, comprising:o DX-G / DX-M digitizer o Cassettes with image plates (NIP/PIP).o NX Workstation(s)o ID Tablet

The key features of the DX-G / DX-M are:o Highest image quality in General Radiography / CR Mammographyo Dose reduction potential in General Radiography / CR Mammographyo Drop & Go buffer functionality to optimize cassette / detector based workflowo Multifunctionality: DX-M supports all CR Genrad applications (General

Radiography, FLFS) as well as Mammo applicationo DX-G supports GenRad only, there is no upgrade possibility to DX-M.

The DX-G / DX-M digitizer will be serviced by Agfa FSEs as well as dealer FSEs. It requires a skill level similar to the DX-S. It is strongly recommended not to let perform service by dealer FSEs until the DICOM digitizer software concept is deployed.

FSEs trained on DX-G can upgrade their knowledge to also service DX-M via self education of service documentation on HealthCare Library

FSE / CAS trained on CR Mammography can upgrade their knowledge to also service the CR Mammo solution based on DX-M via self education of service documentation on HealthCare Library

For FSE / CAS not trained on CR Mammography yet the attendance of the instructor based training for CR Mammography is mandatory.

For Mammography related topics refer to the Service Plan CR Mammo Solution based on DX-M (see 1.2 References)





3 Product Description

3.1 System Overview

The DX-G / DX-M* digitizer is part of a CR system, comprising: DX-G / DX-M digitizer

o Uses flying spot technology for scanning.o Accepts a maximum of 5 cassettes at a time, to be scanned sequentially.o DX-M supports Genrad and Mammography application. o DX-G supports Genrad only, there is no upgrade possibility to DX-M.

CR MD4.0R Plates and Cassettes CR MM3.0R Plates and Cassettes CR HD5.0 Detectors (Plates with Cassettes) (from batch number 9V10 on) CR HM5.0 Detectors (Plates with Cassettes) CR HD5.0 AEC DETECTOR (Plates with Cassettes) The NX Workstation: One or more CR workstations with ID Tablet. ID Tablet (from serial number 15539 on): For identification of the cassette.

Figure 1: Overview of CR System

DX stands for Directrix, the needle-based detector technology offering superb image quality at lower dose.

ID Tablet

NX workstation Digitizer

Hospital Network

Cassettes withImage Plates





For more information on the system overview refer to following document:

# Document Name Reference

1 Service Manual Chapter 11 Installation Planning Extranet Link / Intranet Link2 Service Manual Chapter 2 Software / Hardware

Compatibility ChartExtranet Link / Intranet Link

3.2 Functional Description of the Digitizer

Abbreviated Scan Cycle Description:1. The user inserts the cassette with

exposed image plate (IP) into the digitizer.

2. The cassette unit opens the cassette and the traverse with snap hooks puts the image plate on the IP carrier.

3. The vacuum pump fixes the IP on the IP carrier.

4. The image plate is scanned, while the slow scan unit drives the image plate.

5. The image plate is driven back.

Erasure Unit

Buffer Unit

Connector

Traverse with snaphooks (IP Feeder)

PMT

Light Guide

Optic Module

Laser Beam

Slow Scan DriveVacuum Pump

Vacuum Valve

Gear Box

Spindle

Swivel Unit

IP Carrier

Figure 2

Laser DiodePolygon Mirror

Mirror

Lens System

Description of the Optic Module:

The laser beam is generated by a laser diode.

A 6-facet polygon mirror driven by the polygon motor deflects the laser beam(flying spot technology).

A lens system guarantees a sharp, constant beam in the scan area.

Figure 3





Speed Class free System:

Previous digitizers were using the Speed Class Setting to set the sensitivity of the PMT. The speed class setting can be compared with the ISO speed setting of analog film, and is a configurable parameter on the NX workstation for each examination.

Newer hardware, as it used in the DX-G / DX-M digitizer, does not require this parameter anymore: The dynamic range of the recording system is wide enough, to avoid the necessity to pre-select the speed class.

LogSignal

LogSignal

DX-G Predecessors DX-G

Figure 4: Simplified illustration of dynamic range of the DX-G / DX-M and its predecessors

This means, that the DX-G / DX-M digitizer in combination with the NX workstation is a speed class free system, what makes configuration of the different examinations at the NX workstation more simple.A configuration of the erasure dose is not needed either, since it is set automatically based on the image data.

New Parameter Exposure Index:

In combination with the speed class free operation, a new parameter called Exposure Index (EI) was introduced, which supersedes the Logarithmic median value (LgM Value).The EI is based on IEC 6294-1/CDV (year 2008), whereas the LgM value is an Agfa proprietary measure. It is available since NX version NX 2008.

The LgM is the median value of the measured pixel values in a logarithmic scale, the EI uses a linear scale.Both values are a relative measure for the detector-dose, and can be used by the customer for dose consistency measurement.





Figure 5: Display of the relative dose (LgM or EI) at the NX workstation

For more information on speed class free operation and the Exposure Index refer to following documents:


1 FAQ Exposure Index Extranet Link / Intranet Link2 Simplified Configuration of the Exam-Tree for

AGFA DX-G DigitizersExtranet Link / Intranet Link

For more information on the functional description refer to following document:


1 Service Manual Chapter 02 Functional Description Extranet Link / Intranet Link





3.3 Cassettes and Image Plates

The following table gives a high level overview of available image plates and cassettes:

Name Image Plate Type

Formats (in cm) Compatible with

CR MD4.0R Plate & Cassette

Powder IP (PIP), GenRad

35 x 43 HR, 35 x 35 HR, 35 x 43 SR, 35 x 35 SR, 24 x 30, 18 x 24, 15 x 30, 35 x 43 FLFS

DX-G, DX-M

CR HD5.0 Detector* Needle IP (NIP), GenRad

35 x 43, 24 x 30, 18 x 24, 15 x 30, 35 x 43 FLFS

DX-G, DX-M, DX-S

CR HD5.0 AEC DETECTOR

Needle IP (NIP 35 x 43, 24 x 30, 18 x 24 DX-G, DX-M, DX-S

CR MM3.0R Plate & Cassette

Powder IP (PIP), Mammo

24 x 30, 18 x 24 DX-M only

CR HM5.0 Detector Needle IP (NIP), Mammo

24 x 30, 18 x 24 DX-M only

HR = High Resolution (10 pixel / mm)SR = Standard Resolution (6,6 pixel / mm)FLFS = Full Leg / Full Spine

*From batch number 9V10 onwards, the HD5.0 Detectors are accepted in DX-S and DX-G / DX-M devices.

Figure 6: NIP Figure 7: PIP





For more information on cassettes and image plates refer to following documents:


1 Service Manual Chapter 02 Functional Description

Extranet Link / Intranet Link

2 Datasheet CR MD4.0R Plate & Cassette Extranet Link / Intranet Link3 Datasheet CR MM3.0R Plate & Cassette Extranet Link / Intranet Link4 Datasheet CR HD5.0 Detector Extranet Link / Intranet Link5 Datasheet CR HM5.0 Detector Extranet Link / Intranet Link





3.4 Software Concept

Edition 2 of this Serviceplan is about the DX-G / DX-M digitizers in the DICOM version, e.g. software version NIM_2000 or higher.

DX-M is only available in DICOM version from release on.

NOTES for DX-G:

For information on DX-G digitizer in the TWAIN version , e.g. software version is below NIM_2000 please consult edition 1 of the Service Plan.

DX-G: From NIM_2000 on the complete service functionality is integrated on the digitizer. Communication protocol is DICOM.

Figure 8: Software concept





3.5 Accessories

The following accessories are available for DX-G / DX-M:

Accessory ABC Code DescriptionCR EasyLift EJ8V8 The CR Easylift brings

increased accuracy and ease of operation to Full Leg Full Spine exposures. It enables precise positioning of the CR Full Body Cassette Holder with respect to the X-ray tube, regardless of patient height.

CR Full Body Cassette Holder(Accessory for CR Easylift)

EAUGV Unique, low-wear cassette holder for increased productivity in full body CR Imaging.

CR Anti-scatter grid version 2(Accessory for CR Full Body Cassette Holder)

EMUXJ X-ray grids improve the sharpness of X-ray images by trapping the major part of scatter radiation, resulting in a cleaner, clearer and more detailed image.

CR ID TABLET EPKAP The Identification Station is used to write the cassette, patient, examination and routing data to the cassette chip.

Earthquake kit 5NS2V Fixes the digitizer at the wall and floor for earthquake damage prevention.

Cassettes with image plates / detectors

See corresponding sales information

The number and size of detectors (NIP) or cassettes with image plates (PIP) depends on the individual order.





NOTE for UPS (Uninterruptible power supply):For previous digitizers a UPS was in the accessories assortment. Due to several reasons a dedicated UPS is not offered anymore via ABC code. A UPS can however be offered to the customer and organized locally.Recommendation for the UPS if it is part of the customer order:Select a UPS which is capable to supply 1.200 W (effective power) for a minimum of 5 minutes. Refer to the UPS manufacturer specifications.Note, that the digitizer has no interface (i.e. no RS232/USB) to the UPS. In case of a power failure the customer will not be informed at the digitizer display.

Selecting a UPS with 1.200 W effective power allows connecting digitizer and one Control PC.

NOTE for DX-M digitizer for mobile installations:For ordering a DX-M digitizer for mobile installations, following ABC codes have to be combined:

E4YW2 DX-M digitizer 5RHD8 Mobile kit for DX-M 5NS2V Earthquake Kit for DX-G/DX-M 5PXYS DX-M INSTALL + INITIAL APPLICATION 5RHFD Mobile Kit DX-M Install

DX-M will be delivered prepared for mobile installations. No modification in the field needed.IMPORTANT:It is not possible to order 5RHD8 Mobile kit for DX-M and to modify a DX-M in the field.





4 Product Marketing Strategy

4.1 Target Market Segments and Key Customers

Customers that want to renew their CR equipment (Agfa & competitors) with the advantages in image quality, dose reduction and workflow & functionalityenhancements.

Customers in the analog to digital transition for General Radiography and Mammography that have:o Image quality requirements that cannot be met with the current generation of

powder phosphor plate based CR digitizers.o Workflow requirements to allow a fluent operation of multiple X-ray rooms.

4.2 Key Features of the DX-G / DX-M Digitizer

1. Image quality: Highest image quality in CR General Radiography and CR Mammography.

2. Dose reduction potential for General Radiography and Mammography3. Drop & Go buffer functionality to optimize cassette / detector based workflow4. Multifunctionality: DX-M supports all CR Genrad applications (General Radiography,

FLFS) and Mammography.5. DX-G supports Genrad applications only.





5 Service Strategy

5.1 General

The DX-G / DX-M digitizer is specified to be serviced by Agfa FSEs as well as dealer FSEs.It requires a skill level similar to the DX-S.

5.2 Service Protection Mechanism

The DX-G / DX-M digitizer features a Service Protection Mechanism.By default it is deactivated.If it is activated Service menus can only be accessed via the access code.

This tool can help you to protect your business against unauthorized service providers.In addition it may give you an opportunity to sell licenses.

For more details to the Service Protection Mechanism see following references:

Title Reference

DX-G / DX-M Service documentation, chapter 3.7 Extranet Link / Intranet Link

Service Newsletter No.6 Protecting CR Equipment against unauthorized Service Access.

(An education presentation is included in the Service Newsletter)

Intranet Link

The Profile Knowledge Matrix is intended to outline a high-level overview of the types of resources and knowledge that will be required.It shall help to ensure that the Services resources and the knowledge required to deploy and support the product/solution are available.The proposed Services Training Plan (see section 6 of this document) outlines the training that is proposed for resources responsible for the deployment and support of the product/solution.For Mammography related topics refer to the Service Plan CR Mammo Solution based on DX-M (see 1.2 References)





Role Responsibilities / Activities General Knowledge / Skills Product Specific Knowledge

Project Manager

Project definition and creation of project plan

Building of the project team Coordination of resources and

timing based on input of the specialist

Continuous review and documentation of project status and costs

Coordination and synchronization of all AGFA and 3rd party activities towards the customer (except civil works)

Management of customer, FSE, CAS, Sales, Service, 3rdparty and Country institutions

Closure of the project after implementation phase

Project Management

Local Language and English

Detailed system implementation steps and milestones

Basics on system components

Basics system Workflow

Basics about local regulatory for X-Ray environment

X-Ray workflow

Basics about CR technology





Role Responsibilities / Activities General Knowledge / Skills Product Specific Knowledge

Regional Service Desk Level 1 Support -FSE

Consultant for project manager at site planning concerning technical details

On-site visits (Installation, CM, PM)

Telephone and E-Mail support

Escalation of problems

On site support if required

Local language and English Good PC knowledge Basic X-Ray knowledge Local certificates to do X-Ray

exposures Local admission to work on X-Ray

devices Basic network and connectivity

knowledge Basic knowledge about CR

imaging (workflow, differences "analog" to "digitial" imaging).

Radiation protection rules according to local legal and regulatory requirements

General safety and electrical safety rules according to local legal regulations

System corrective maintenance (CM) and preventive maintenance (PM) procedures

Technical Installation steps Configuration possibilities Troubleshooting Replacements, Adjustments,

Calibrations Performing of service ATP

Regional Service Desk Level 1 Support -CAS

Consultant for project manager at site planning concerning application workflow

Customization of the systemalong the lines of the customers wishes and the statement of work

Acceptance testing

Customer Training

Local language and English Basic experience in operating a

PC Didactical skills Local certificates to do X-Ray

exposures

Experience in Genrad image quality evaluation

System customization possibilities System workflow and application

possibilities and limitations Image quality potential of CR-

devices together with AGFA MUSICA processing

Level 2 Support




Conducting Service trainings for FSE and CAS

Analytical skills

Good PC knowledge

Advanced network and connectivity knowledge

General X-Ray and CR knowledge


Technical Installation steps Replacements, Adjustments,

Calibrations Troubleshooting Configuration possibilities

Level 3 Support




Strong analytical skills Good PC knowledge

Advanced network and connectivity knowledge

General X-Ray and CR knowledge


Technical Installation steps Replacements, Adjustments,

Calibrations Troubleshooting in depth Configuration possibilities

Table 1: Profile - Knowledge Matrix





5.3 Project Management & Site Planning

The table enclosed lists references to further information concerning project management and site planning:

# Reference Location

1 Project management in general imap (Intranet Link)2 Project management training See ALP http://healthcare.agfa.net/irj3 Project Management NX

WorkstationsHealthCare Library / CR Workstation Software

4 CR Mammography Solution DX-M Project Management Guide (Extranet Link / Intranet Link)

5 Installation Planning Document DX-G / DX-M

(Extranet Link / Intranet Link)

Table 2

For Mammography related topics refer to the Service Plan CR Mammo Solution based on DX-M (Extranet Link / Intranet Link).

5.3.1 Interoperability / Compatibility Matrix

For the Interoperability matrix refer to section 2, Functional Description - Software Hardware Compatibility Chart (Extranet Link / Intranet Link).





5.4 Professional Services

DX-G / DX-M offers the potential for professional services like the other digitizers. For details refer to:

Title Reference

ASPAC Services contacts ASPAC services

EMEA Professional Services home page EMEA Professional Services

NAFTA Professional Services homepage NAFTA Professional Services

5.5 Staging & Logistics

The digitizer is pre-configured in production to run out of the box as an offline installation as soon as the NX workstation is prepared. Hospital network integration has to come subsequently.For the NX staging process refer to the corresponding NX Service Plan.





5.6 Installation

NOTE:

This section considers the digitizer installation only. See the corresponding NX service plan for further information concerning NX workstation installation.

It is recommended to perform the installation in two steps, as described in the Technical Documentation chapter 1 (Extranet Link / Intranet Link):o First step: Direct connection between DX-G / DX-M and NX workstationo Second step: Integration of the system in the hospital network

For details to the digitizer installation steps refer to the

Statement of Work Installation, section 11.2.

Function Description Performed By Duration

Unpacking Unpacking Forwarder 10 min.

Installation Preparation

Removing transport locks, moving digitizer at final location

FSE 5 min.

Basic Configuration Digitizer configuration at NX workstation; Filling in of site specific data, maintenance indicator configuration

FSE 25 min.

Image quality check Flatfield creation and evaluation FSE 20 min.MTTI (Mean Time To Install) 1 h





5.7 End-User Training

End-users defined by the customer (consider max. number of trainees) have to be trained in :

The basic tasks as described in the user manual DX-G / DX-M.

Usage of the ID tablet as described in the user manual Getting started with the ID Tablet.

The usage of image plates and cassettes as described in the user manual AGFA CR Detectors, Plates and Cassettes (CR HD5.x, CR MD4.xR, CR MM3.xR, CR HM5.x).

For details refer to the





Statement of Work Customer Training, section 11.3.

5.8 Field Service & Escalation

5.8.1 Field Troubleshooting & Repair

The troubleshooting strategy is similar to the other Agfa HealthCare digitizers:

Error codes lead to the defective part.

Functions in the service software, like info counter, endurance run and diagnose cycle support troubleshooting.





5.8.2 Spare Parts

Spare parts are mainly defined on mechanical module and printed circuit board level.

NOTE:Cables that not are defined as spare part, but needed for repair should be noted to RSN / GSN. Please find the reference for the numbers in the circuit diagrams (see example below).

Figure 9: Example for cable number in circuit diagram

There is no general recommendation for local stock of spare parts as DX-G / DX-M is on the market for some years already.Spare part usage is monitored at Spare Part Management team.For information on current status of most frequently used spare parts contact the Spare Parts Management team via [email protected] .





Returnable parts contain valuable components and are fed into the value creation process for spare parts again. They are indicated with a red label or with a special sticker fro parts shipped from parts center in the USA. See Figure 10.

Inspection parts are sent back to an inspector at AGFA to support quality improvement activities. They are indicated with a yellow label. See Figure 10.

Figure 10

For more details on spare parts see following references:

Title Reference

DX-G / DX-M Spare Parts List Extranet Link / Intranet Link

Statement of Work Corrective Maintenance Section 11.4

HealthCare Global Procedure Return of Healthcare Spare Parts

See IMS (Integrated Management System)

Please return the defective,exchanged part back to

for inspection

Central Return WarehouseAGFA HealthCare

at Matrium GmbHUnterschleiheim

Sticker on return able parts: Sticker on inspection parts:

Sticker for parts shipped from Parts Center in the U.S.

Sticker for parts shipped from the rest of the world





5.8.3 Preventive Maintenance

DX-G:Frequency: Every 37.500 cycles or every 18 months, whatever happens first.

DX-M:Frequency: Every 25.000 cycles or every 12 months, whatever happens first.

Via software switch (DX-G / DX-M Service Software Preventive Maintenance Maintenance Indicator) it is possible to display following user message at the NX workstation to inform the customer about a preventive maintenance visit:

"Maintenance interval will expire within a short time. Please contact service."

The appearance of that message is configurable (operation hours or cycles). Default values are:

o This message appears approximately 6 weeks before the fixed defined maintenance counter (1 year / 25.000 cycles) is reached.

o "Maintenance interval expired. Please contact service." appears, when the fixed maintenance counter is reached.

The table enclosed gives a high level overview of the preventive maintenance task:

Task Description Performed By Duration

Maintenance Check condition; cleaning; check image quality; final test

FSE Average < 2 h

For details refer to the Statement of Work Preventive Maintenance, section 11.5.





5.8.4 Escalation

Support for DX-G / DX-M is provided according to the standard support processes. The product IDs in PowerHelp are:

DX-G: ADC DX-GDX-M: ADC DX-M

5.8.4.1 Escalation before Customer Solution Hand-over

Level 2Level 1 Level 3

Customer

Local FSE

Local CAS

PQRT / R&D

Regional SupportNetwork Technician

Regional SupportNetwork ClinicalApplication

GSN

FSE = Field Service EngineerCAS = Clinical Application Specialist = FAS = Field Application SpecialistGSN = Global Support NetworkPQRT = Product Quality Review TeamR&D = Research and Development

Escalation path for technical problems:Customer local FSE Regional Support Network GSN PQRT / R&D

Escalation path for application problems:Customer local FAS Regional Clinical Appl. GSN PQRT / R&D





5.8.4.2 Escalation after Customer Solution Hand-over

Level 2Level 1if remote fixable

Level 3

Customer CCC

Local FSE

Local CAS

PQRT / R&D

Regional SupportNetwork Technician

Regional SupportNetwork ClinicalApplication

GSN

CCC = Customer Care CenterFSE = Field Service EngineerCAS = Clinical Application Specialist = FAS = Field Application SpecialistGSN = Global Support NetworkPQRT = Product Quality Review TeamR&D = Research and Development

Escalation path for technical problems:Customer CCC (=Customer Care Center) local FSE Regional Support Network GSN PQRT / R&D

Escalation path for application problems:Customer CCC local FAS Regional Clinical Appl. GSN PQRT / R&D

Level 2 Support phone numbers:

Level 2 ASPAC EMEA Americas

Follow the sun

+ 61 3 98 94 30 46 +49 89 6207 3427 PACS+49 89 6207 3361 CR/DR

+ 1 201 373 08741-877-777-AGFA (US only)

Above are AGFA HEALTHCARE internal numbers (Except US). Customers usually call their local/regional CCC. Calls will be routed then internal to above numbers.





5.8.5 Remote Service

Remote service access to the DX-G / DX-M is possible via web interface.

For more info on remote service see:Title Reference

SRSS homepage Intranet Link

5.8.5.1 Remote Service by Agfa HealthCare

Agfa HealthCare utilizes SRSS (Secure Remote Service Solution) for the remote service of its HealthCare customers. A SRSS connection is vital for all our IT solutions in order to provide efficient and professional support.This link provides the user with an introduction to the SRSS.For more information about SRSS, please access the following link on the HealthCare Library. HealthCare Library Technical Services Service Delivery SRSS ServiceManual





5.9 MIGRATIONS/UPGRADES

Since second half of 2010 an upgrade is available for the DX-G installed base with software version below NIM_2000, i.e. TWAIN concept.After that upgrade, DX-G and DX-M will share one software version. The intended use of the devices (DX-G for GenRad, DX-M for GenRad and Mammo) will not change thereto.It is not possible to change the intended use in the field.

5.10 COMMUNITY OF PRACTICE (CoP)

A Community of Practice (CoP) is a group of people who collaborate on an ongoing basis to share knowledge or solve problems in a given domain. Agfa HealthCare utilizes the CoP functionality in Livelink for groups to collaborate on best practices or problem solving and as a knowledge sharing forum.

NOTE:For the DX-G / DX-M no community of practice has been set-up.





6 Training

6.1 Training Path

Following prerequisites are required to apply for the instructor based training DX-G / DX-M (see Figure 11): WBT "Basics of Digital Radiography"

WBT Basics of DX-G / DX-M Digitizer

NX training

The WBT Basics of DX-G / DX-M Digitizer is followed by a mandatory test.Booking of the IBT is only possible after successful completion of the test.

Figure 11: DX-G / DX-M qualification path

2 days DX-G / DX-M IBT- System knowledge

- Hands-on - All replacements - Adjustments - Calibrations - Troubleshooting: Tools, circuit diagrams -

- Installation

Preventive MaintenancePREREQUISITES

Basic Skills- Good English language skills- Knowledge on computer systems (operating system, hardware, network basics)

WBT "Basics of Digital Radiography"

NX TrainingWBT "Basics of DX-G /DX-M Digitizer





For more info on training see:Title Reference

ALP (Academy Learning Platform): Service Training information Registration for Classroom Training Web Based Training Training Calendar Exams and certification processes Intended audiences

http://healthcare.agfa.net/irj

Field Service ABCs Extranet Link / Intranet Link

6.1.1 Strategy for DX-G trained Field Service Engineers (DX-G with TWAIN concept: software version below NIM_2000)

A high number of FSEs are trained already on DX-G.The strategy for knowledge upgrade to also service DX-M has been set up to be most cost efficient.

6.1.1.1 Genrad

FSEs trained on DX-G can upgrade their knowledge to also service DX-M via self education of service documentation on HealthCare Library.

6.1.1.2 Mammography

FSE / CAS trained on CR Mammography can upgrade their knowledge to also service the CR Mammo solution based on DX-M via self education of service documentation on HealthCare Library.For FSE / CAS not trained on CR Mammography yet the attendance of the instructor based training for CR Mammography is mandatory.For Mammography related topics refer to the Service Plan CR Mammo Solution based on DX-M (see 1.2 References).





7 Documentation & Software

NOTE:Documents and software listed here shows the status at release for delivery of the digitizer.To stay up-to-date create an appropriate user profile in the HealthCare Library. For instructions refer to "The Field Service ABCs" (Extranet Link / Intranet Link).To get information on the possibilities to administrate HealthCare Library accesses for external partners refer to the Imaging Services Newsletter 2011-003 - Agfa HealthCare Library replaces MedNet HealthCare and MedNet GSO Libraries (Intranet Link).

7.1 Documentation

Title/Description of Document Location

Service Documents

DX-G / DX-M - Chapter 00 - About this Manual Extranet Link / Intranet Link

DX-G / DX-M - Chapter 00 Orderlist, Checklist for Completeness Extranet Link / Intranet Link

DX-G / DX-M - Chapter 00 - Generic Safety Directions Extranet Link / Intranet Link

DX-G / DX-M - Chapter 01 - Controls, Connections and Setup Procedures


DX-G / DX-M - Chapter 02 - Functional Description Extranet Link / Intranet Link

DX-G / DX-M - Chapter 02 - Functional Description - Interoperability Matrix


DX-G / DX-M - Chapter 03.1 - Safety Guidelines General Repair Instructions


DX-G / DX-M - Chapter 03.2 - Tools and auxiliary Means Extranet Link / Intranet Link

DX-G / DX-M - Chapter 03.3 - Troubleshooting Works in progress

Consult Service bulletins

DX-G / DX-M - Chapter 03.4 - Codings, Fuses, LEDs Extranet Link / Intranet Link

DX-G / DX-M - Chapter 03.5 Replacements Repair Procedures Extranet Link / Intranet Link

DX-G / DX-M - Chapter 03.6 - Adjustments and Calibration Extranet Link / Intranet Link

DX-G / DX-M - Chapter 03.7 - Software Menus, Settings Extranet Link / Intranet Link

DX-G / DX-M - Chapter 03.8 - Software Releases and Patches Extranet Link / Intranet Link

DX-G / DX-M - Chapter 04 - Reference and Circuit Diagrams Extranet Link / Intranet Link

DX-G / DX-M - Chapter 05 - Spare Parts List Extranet Link / Intranet Link

DX-G / DX-M - Chapter 06 - Accessories Extranet Link / Intranet Link





DX-G / DX-M - Chapter 09 - Maintenance Extranet Link / Intranet Link

DX-G / DX-M - Chapter 11 - Installation Planning Extranet Link / Intranet Link

ID Tablet Spare Parts List Extranet Link / Intranet Link

Service Manual NX X.0.8500 / X.0 8500 Extranet Link / Intranet Link

IEC 62353 Test Protocol (> Edition.Revision 1.0) Extranet Link / Intranet Link

Service Manual CR Mammo Solution DX-M Extranet Link / Intranet Link

User Documents

Datasheet DX-G Extranet Link / Intranet Link

Datasheet DX-M Extranet Link / Intranet Link

Datasheet CR MD4.0R Plate & Cassette Extranet Link / Intranet Link

Datasheet CR MM3.0R Plates & Cassette Extranet Link / Intranet Link

Datasheet CR HD5.0 Detector Extranet Link / Intranet Link

Datasheet CR HM5.0 Detectors Extranet Link / Intranet Link

DX-G / DX-M User Manual Extranet Link / Intranet Link

Getting started with DX-G / DX-M Extranet Link / Intranet Link

Getting started with the ID Tablet Extranet Link / Intranet Link

AGFA ID Tablet Plug & Play Installation Manual Extranet Link / Intranet Link

CR Detectors, Plates and Cassettes Extranet Link / Intranet Link

7.2 Software Packages Titles & Download Locations

Software Package Title Location

Digitizer Software NIM_2311 Extranet Link / Intranet Link

Limit Patterns Extranet Link / Intranet Link





8 Service AgreementsService Agreements are confidential contractual information. For further questions concerning this subject please contact your local service manager.

For the Service agreements (only accessible for HealthCare Library Users with tactical or strategic level) click here





9 APPENDIX A Technical Specifications

Scan technology Flying spot digitizer

Resolution Mammo Resolution: 20 pixel / mmHigh Resolution: 10 pixel / mmStandard Resolution: 6,66 pixel / mm

Throughput Between 40 and 117 plates/h, depending on IP size, resolution and applicationFor details refer to datasheet DX-G and datasheet DX-M in 7.1 Documentation

Interface Ethernet RJ45

Network protocols(TCP/IP services)

DICOM, HTTP

Image formats DICOM

Input buffer size 5 cassettes

Cassette formats 35 x 43 cm, 35 x 35 cm, 24 x 30 cm, 18 x 24 cm,15 x 30 cm

Operating temperature +15 C +30 C (59 F 86 F)

For use with CR HM5.0 Detector

20 C - 30 C (68 F 86 F)

Operating RH 15% 75% RH - non condensing

Customer installable No

Dimensions Approx. W: 115,0 cm, D : 51,0, H : 123,0 cm

Weight Approx. 180 kg

Power requirements 100 V to 240 VAC (autosensing) 50/60 Hz

220 V - 240 V / 50-60 Hz

configuration (typical values)

Standby power approx. 87 WAverage (continuous operation): 237 WMax. power consumption 590 W

100 V - 120 V / 50-60 Hz

configuration (typical values)

Standby power approx. 92 WAverage (continuous operation): 245 WMax. power consumption 621 W

Mobile compliance DX-M: yes DX-G: no

Earthquake kit Option

Table 3





For more information on technical specifications refer to following documents:


1 Datasheet DX-G digitizer Extranet Link / Intranet Link

2 Datasheet DX-M digitizer Extranet Link / Intranet Link

3 Service Manual - Chapter 11 - Installation Planning Extranet Link / Intranet Link

9.1 Typical Load

Typical # of Cycles Time frame

100 Day

2000 Month

25000 Year

Table 4

9.2 Service Metrics and KPIs (Specified Target Values)

The figures presented here are strictly related to the digitizer only. For NX workstation data refer to the respective Service Plan (see 1.2 References)

MTTI (Mean Time To Install) 1 h / one person

MTTM (Mean Time To Maintain) 2 hours incl. Quality check

MTBM (Mean Time Between Maintenance) 12 months

MCBM (Mean Cycles Between Maintenance) 25.000 cycles

MTTR (Mean Time To Repair, includes MFTD) 0,8 h

Average maintenance parts costs per year 20,76 (EUR4)

Service support time, parts availability End of production + 7 years

Table 5





NOTE for DX-M digitizer for mobile installations:MTTI, MTTM and MTTR are higher. For details see 11 APPENDIX C Statements of Work

9.3 Reliability (specified target values)

MTBF (Mean Time Between Failure) See section 8, Service Agreements.

MCBF(Mean Cycles Between Failure) See section 8, Service Agreements.

Table 6

10 APPENDIX B Spare Parts Listings

A spare parts list with status "release for delivery" is available as part of the Statement of Work Corrective Maintenance, section 11.4.

NOTE:This statement of work represents the status of release for delivery.For an up-to-date version of spare part list refer to HealthCare Library (Extranet Link / Intranet Link.





11 APPENDIX C Statements of Work

11.1 Statement of Work Pre-Installation

The listed pre-installation activities have to be performed prior to installation to accomplish the given timeframe.

Required time: 4 hours

# Activity Task code

1 Ask the Agfa sales representative for a contact person in the hospital. PRI

2 Make yourself familiar with the System Overview. PRI

3 Make yourself familiar with the scope of delivery. PRI

4 Make yourself familiar with the digitizer specifications. PRI

5 Have a look at the digitizer safety standards and regulations. PRI

6 Have a look at the machine dimensions. PRI

7 Ensure the required free space around the digitizer. PRI

8 Make an appointment with the network administrator and check the network access. Initiate to establish necessary amount of IP addresses at installation time.

PRI

9 Make an appointment with the radiologist for operator training. PRI

10 Make an appointment with the hospital technician to prepare mounting of the optional earthquake kit. PRI

11 Make an appointment with the hospital technician to define delivery and transport path. PRI

12 Compare the required ambient and climatic conditions with the condition at the installation place. PRI

13 Make an appointment with the house electrician or the authorized electrician and check the required electrical connection. PRI

14 Check the installation readiness during follow up visit. PRI

Table 7





NOTE:This statement of work represents the status of release for delivery.For an up-to-date list of activities refer to the Installation Planning document (Extranet Link / Intranet Link).NOTE for DX-M digitizer for mobile installations:The Earthquake kit is also used as mobile kit for mobile installations of DX-M.Wall fixation and base plate of the mobile kit have to be mounted by a technician of the trailer / van with adequate fixation means. This step may influence the installation time significantly.

11.2 Statement of Work Installation

The listed installation activities prerequisite a successfully performed pre-installation in order not to exceed the given timeframe.

Required time: 1 hour including image quality check, without steps # 17 to # 22.


1 Check installation site prerequisites. PRI

2 Unpack digitizer*. INS

3 Check shipment completeness. INS

4 Move digitizer at final position. INS

5 Mount optional earthquake kit. INS

6 Remove transportation locks, connect cables and lower digitizer at final position. INS

7 Install digitizer software on Control PC. INS

8 Switch digitizer on. INS

9 Install and configure NX Workstation. INS

10 Configure the digitizer. INS

11 Fill in Site specific data. INS

12 Configure Maintenance Indicator. INS

13 Check technical image quality of the digitizer system. INS

14 Save HOT (hand-over test) file. INS

15 Perform a backup. INS

16 Hand-over the system to the Clinical Application Specialist. INS






17 Integrate NX workstation into the hospital network. ASC

18 Integrate DX-G into the hospital network. ASC

19 Setup connectivity to additional system components (RIS, PACS, Hardcopy, ).ASC

20 Customize system components according to customer preferences. ASC

21 Train the customer. ATR

22 Check for further activities depending on local regulations. ABA* preferably to be done by the forwarder

Table 8

NOTE:This statement of work represents the status of release for delivery.For an up-to-date list of activities refer to chapter 1 of the service manual (Extranet Link / Intranet Link).NOTE for DX-M digitizer for mobile installations:DX-M will be delivered prepared for mobile installations. No modification in the field needed.Nevertheless additional effort has to be calculated depending on layout and accessibility of mobile installation location.





11.3 Statement of Work Customer Training

Required time: approx. 2 hoursCustomer training of NX Workstation is not included.Please refer to respective customer training for NX Workstations.

11.3.1 Handover of User ManualsHand-over the user manuals (which are also available on the HealthCare Library):

# User Manual Reference to digital Version on HealthCare Library

1 DX-G / DX-M User Manual Extranet Link / Intranet Link2 Getting started with DX-G / DX-M Extranet Link / Intranet Link3 Getting started with the ID Tablet Extranet Link / Intranet Link4 CR Detectors, Plates and Cassettes Extranet Link / Intranet Link

11.3.2 Customer Training

Train the customer in following activities:

Operating the digitizer. See section 11.3.2.1.

Operating the ID tablet. See section 11.3.2.2. Usage of detectors, plates and cassettes. See section 11.3.2.3.

11.3.2.1 Training for Operating the Digitizer

Required time: approx. 1,5 hours

Following items have to be part of the training for digitizer operation.

Cleaning the exterior of the DX-G / DX-M

Cleaning the touch panel Cleaning the optical unit with the integrated brush

Replacing the air filter element

The user interface (Status indicator / touch panel / status messages at NX Workstation)

Switching on/off/reset the digitizer

Power and network connector

Boot-up procedure

Basic workflow

Erasing image plates





Turning the volume of the digitizer signals and beeps on or off

Changing the brightness of the touch panel Retrieving Information about the digitizer

Moving the digitizer

Troubleshooting and errors during operation

Mobile installations:o operating the transport lockso locking the device for moving the trailer / vano protecting the device from pollution

See DX-G / DX-M User Manual and user manual Getting started with DX-G / DX-M for more details and an explanation of the single items.

For NX Workstation specific training refer to the NX Workstation user documentation.

11.3.2.2 Training for Operating the ID Tablet


Following items have to be part of the training for ID tablet operation.

Switching on/off the ID tablet

Identifying cassettes of different formats with the ID tablet

Steps at the NX Workstation for identifying a cassette

See user manual Getting started with the ID Tablet for more details and for an explanation of the single items.

11.3.2.3 Training for Usage of Detectors, Plates and Cassettes


Following items have to be part of the training for usage of detectors, plates and cassettes:

Difference NIP/PIP plates and cassettes

Labels and functional elements of the cassettes

How to detect Full Leg / Full Spine Cassettes (if available on site) First use and normal operation





Storage and transport

Operating conditions Cleaning

See user manual CR Detectors, Plates and Cassettes for more details and for an explanation of the single items.

11.3.2.4 Performing further Activities depending on local Regulations

Enclosed a list of possible activities depending on local regulations:This list is just an example.The activities which are required have to match and fulfill local regulations.

# Activity Reference 1 Electrical check IEC 62353:2007 Test Documentation on the

HealthCare Library (Extranet Link / Intranet Link)

2 Acceptance Test Example for Germany: DIN6868





11.4 Statement of Work Corrective Maintenance

The table enclosed lists the spare parts that were defined at release for delivery DX-G, as well as the replacement time per spare part. It is valid for DX-M as well.

NOTE:This statement of work represents the status of release for delivery.For an up-to-date version of spare part list refer toHealthCare Library (Extranet Link / Intranet Link.NOTE for DX-M digitizer for mobile installations:For mobile installations the DX-M is always fixed to the wall and floor. An additional effort of approx. 30 minutes has to be considered in average.

The replacement time is split-up in following single times:

Abbreviation Explanation

TP Average Preparation time, Pre-analysis of the problem, preparation of the right spare part

TFI Average fault isolation time

TD Average disassembly time, Time to disassemble a module

TI Average interchange time. This is set to "0" for all spare parts. TI is already part of TD and TR.

TR Average reassembly time, Time to reassemble a module

TA Average alignment time, Time to do adjustments, calibrations, reload software

TC Time for checkout, verification of function, Warm-up, scan test image, evaluate images

TST Time for set-up, hand-over to customer





Spare Part No. Description TP TFI TD TI TR TA TC TSTTotal[min]

CM+9 5160 4517 0 Stepper Motor Opener (M201) 15 10 10 0 10 10 10 10 75CM+9 5160 4750 0 Buffer Adapter Board (B220) 15 15 10 0 10 0 10 10 70CM+9 5160 5006 0 Antistatic Brush 15 15 20 0 20 0 10 10 90CM+9 5170 0860 0 Software 15 15 10 0 10 0 10 10 70CM+9 5170 1410 2* Buffer Rear Cover 15 0 5 0 5 0 10 10 45CM+9 5170 1421 0* Upper right cover 15 0 5 0 5 0 10 10 45CM+9 5170 1430 0* Buffer Right Cover 15 0 5 0 5 0 10 10 45CM+9 5170 1440 1* Right cover 15 0 5 0 5 0 10 10 45CM+9 5170 1445 1 Display Board with Touch Panel 15 10 10 0 10 0 10 10 65CM+9 5170 1450 1* Left Cover 15 0 5 0 5 0 10 10 45CM+9 5170 1455 1* Upper left cover 15 0 5 0 5 0 10 10 45CM+9 5170 1460 0 LED-Status-Indicator 15 10 10 0 10 0 10 10 65CM+9 5170 1475 2* Front Cover 15 0 5 0 5 0 10 10 45CM+9 5170 1479 2* Upper Cover 15 0 5 0 5 0 10 10 45CM+9 5170 1827 0 Cover Plate 15 0 5 0 5 0 10 10 45CM+9 5170 2120 0 Swivel Drive 15 30 15 0 15 10 10 10 105CM+9 5170 2150 0 IP Handling Board 15 30 10 0 10 10 10 10 95CM+9 5170 2185 0 Locking motor (M626) 15 20 15 0 15 10 10 10 95CM+9 5170 2190 0 Connector Bolt 15 20 20 0 20 0 10 10 95CM+9 5170 2360 0 Vacuum Valve 15 30 10 0 10 0 10 10 85CM+9 5170 2380 0 Vacuum Plate 15 30 10 0 10 0 10 10 85CM+9 5170 2470 1 Traverse on IP carrier sensor 15 30 10 0 10 0 10 10 85CM+9 5170 2475 0 Traverse locked on carriage sensor 15 30 10 0 10 0 10 10 85CM+9 5170 2490 0 Distribution Board IP-Carrier 15 10 10 0 10 0 10 10 65CM+9 5170 2585 0 Slow Scan Reference Sensor 15 15 15 0 15 0 10 10 80CM+9 5170 2630 0 Traverse with snap hooks 15 15 15 0 15 30 10 10 110CM+9 5170 2690 3 Snaphook Drive 15 30 15 0 15 10 10 10 105CM+9 5170 2715 1 Rope Tensioner Center 15 15 10 0 30 0 10 10 90CM+9 5170 2725 1 Rope Tensioner Right 15 15 10 0 30 0 10 10 90CM+9 5170 2730 1 Rope Tensioner Left 15 15 10 0 30 0 10 10 90CM+9 5170 2750 0 Optic Module 15 60 10 0 10 60 50 10 215CM+9 5170 2990 1 Calibration Board 15 20 10 0 10 0 10 10 75CM+9 5170 3001 0 PMT with Light Collector 15 45 10 0 10 60 50 10 200CM+9 5170 3035 0* Cleaning Brush Assembly 15 30 20 0 20 0 10 10 105CM+9 5170 3070 1 PMI52 Board 15 30 10 0 10 0 10 10 85CM+9 5170 3500 1 Erasure Unit 15 30 10 0 10 0 10 10 85CM+9 5170 4010 0 Cable IP board to SM carrier 15 30 10 0 10 0 10 10 85CM+9 5170 4011 1 CAN Bus cable 15 30 20 0 20 10 10 10 115CM+9 5170 4014 2 Cable PMI52 to calibration 15 30 20 0 20 0 10 10 105CM+9 5170 4030 1 SM Linear Transport (M514) 15 15 20 0 20 20 10 10 110CM+9 5170 4120 1 PMI52 Power Distribution Board 15 30 10 0 10 0 10 10 85CM+9 5170 4210 2 Dsitribution board cable 15 30 10 0 10 0 10 10 85CM+9 5170 4250 0 Display Control Board Cable 15 30 20 0 20 0 10 10 105CM+9 5170 4270 0 Cable PMT - PMI 15 30 5 0 5 0 10 10 75CM+9 5170 4290 2 Vacuum Pump 15 30 20 0 20 0 10 10 105





Spare Part No. Description TP TFI TD TI TR TA TC TSTTotal[min]

CM+9 5170 4330 0 Cassette Transport Home Pos Cable 15 30 10 0 10 0 10 10 85CM+9 5170 4380 0 Cable PMI52 to PWR Distribution Board 15 30 5 0 5 0 10 10 75CM+9 5170 4390 0 Cable PMI to Optic Module 15 30 5 0 5 0 10 10 75CM+9 5170 4450 0 Fan 15 10 15 0 15 0 10 10 75CM+9 5170 5230 1 Z-Sensor 15 15 15 0 15 0 10 10 80CM+9 5170 5270 0 Cassette Grabber 15 15 15 0 15 10 10 10 90CM+9 5170 5600 1 Locking Unit 15 15 15 0 15 10 10 10 90CM+9 5170 5316 0 Stepper Motor Cassette Transport 15 20 10 0 10 10 10 10 85CM+9 5170 5955 0 Cassette reader cable 15 30 10 0 10 0 10 10 85CM+9 5170 5990 0 Cassette Handling Board 15 15 10 0 10 10 10 10 80CM+9 5170 6000 0 Buffer Unit 15 30 20 0 20 10 10 10 115CM+9 5170 9120 0 Stepper Motor Swivel Drive (M625) 15 30 15 0 15 10 10 10 105CM+9 5170 9160 0 Cleaning Brush 15 30 15 0 15 0 10 10 95CM+9 5170 9805 0 Power Supply 15 20 15 0 15 0 10 10 85CM+9 5170 9810 0 Cassette Transport Belt 15 10 15 0 15 0 10 10 75CM+9 5170 9815 0 Transport Kit 15 15 10 0 10 0 20 10 80CM+9 5170 9820 0 Small Parts Kit Fixing material 15 15 10 0 10 0 10 10 70CM+9 5170 9825 0 Small Parts Kit Functional Parts 15 15 10 0 10 0 10 10 70CM+9 5170 9830 0* Rear Cover 15 0 5 0 5 0 10 10 45CM+9 5170 9835 0* Cassette Input Cover 15 0 5 0 5 0 10 10 45CM+9 5170 9845 0* Lower Buffer Cover 15 0 5 0 5 0 10 10 45CM+9 5170 9850 0 Roller 15 0 15 0 15 0 10 10 65CM+9 5170 9855 0 Air Filter 15 5 10 0 10 0 10 10 60CM+9 5170 9860 0 Interlock Switch 15 10 10 0 10 10 10 10 75CM+9 5170 9865 0 Main Switch 15 10 10 0 10 0 10 10 65CM+9 5170 9870 0 Traverse Carriage Left / Right 15 15 10 0 10 30 10 10 100CM+9 5170 9875 0 IP Feeder Wire Ropes 15 10 30 0 30 0 20 10 115CM+9 5170 9880 0 Linear Transport Belts 15 15 20 0 20 30 10 10 120CM+9 5170 9885 0 Solid State Disk 15 15 10 0 10 20 10 10 90CM+9 5170 9889 0 Housing 15 0 5 0 5 0 10 10 45CM+9 5170 9890 0 Lubricating Chambers 15 30 15 0 15 0 10 10 95CM+9 5170 9892 0* Calibration Board Cover 15 20 10 0 10 0 10 10 75CM+9 5170 9893 0 Movable Vacuum Hose with Wire 15 30 20 0 20 0 10 10 105CM+9 5170 9894 0 Fixed Vacuum Hose 15 20 10 0 10 0 10 10 75CM+9 5170 9895 0 Vacuum Pump Sound Absorber Hose 15 5 10 0 10 0 10 10 60CM+9 5170 9896 0 Rollo cassette clamping 15 20 10 0 10 10 10 10 85CM+9 5170 9898 0 Cassette Edge Sensor 15 15 10 0 10 10 10 10 80CM+9 5170 9899 0 Chip Reader 15 15 15 0 15 0 10 10 80CM+9 5175 8660 1 Stepper Motor Cassette Fixation 15 15 15 0 15 10 10 10 90

* means: Spare part not physically on stock due. Prolonged delivery time.





11.5 Statement of Work Preventive Maintenance

The listed maintenance activities have to be performed every 25.000 cycles or once per year.

Required time: 2 hours including image quality check


1 Questioning of the customer PMV2 Error statistics PMV3 Infocounter analysis PMV4 Reset of the relative counters PMV5 Checking current image quality PMV6 Visual inspection

Check visually power and network cable. Check visually the covers. Check visually the cleaning brush. Check visually the cables inside the digitizer. Check visually the belts. Check visually the flexible vacuum hose. Check visually the spindle. Check visually the parallelism of the Traverse.

PMV

7 Cleaning general PMV8 Cleaning of the erasure unit PMV9 Checking of spindle PMV10 Checking of cassette condition PMV11 Replacing the air filter PMV12 Checking safety switch PMV13 Performing stall calibration PMV14 Performing test cycles PMV15 Technical image quality check of the system PMV16 Reset of maintenance indicator PMV17 Creating a backup of device specific data PMV18 Customer conversation PMV





NOTE:This statement of work represents the status of release for delivery.For an up-to-date list of activities refer to the Preventive Maintenance Instructions (Extranet Link / Intranet Link).NOTE for DX-M digitizer for mobile installations:For mobile installations the DX-M is always fixed to the wall and floor. An additional effort of approx. 30 minutes has to be considered in average.





12 Abbreviations

ASAP Agfa Scanner Access Package

CAS Clinical Application Specialist

CCC Customer Care Center

CM Corrective Maintenance

CR Computed Radiography

DRA Device Readiness Assessment

ELMS Electronic Licensing Management System

FSE Field Service Engineer

GSN Global Support Network

GTC Global Training Center

GUI Graphical User Interface

IBT Instructor Based Training

NIP Needle Image Plate

PIP Powder Image Plate

PM Preventive Maintenance

PMT Photomultiplier

PMV Preventive Maintenance Visit

PQRT Product Quality Review Team

R&D Research & Development

RIS Radiology Information System

UPS Uninterruptible Power Supply

WBT Web Based Training

Service Plan DX-M1 Introduction1.1 Changes (Revision History)1.2 References

2 Summary of Service Plan3 Product Description3.1 System Overview3.2 Functional Description of the Digitizer3.3 Cassettes and Image Plates3.4 Software Concept3.5 Accessories

4 Product Marketing Strategy4.1 Target Market Segments and Key Customers4.2 Key Features of the DX-G / DX-M Digitizer

5 Service Strategy5.1 General5.2 Service Protection Mechanism5.3 Project Management & Site Planning5.3.1 Interoperability / Compatibility Matrix

5.4 Professional Services5.5 Staging & Logistics5.6 Installation5.7 End-User Training5.8 Field Service & Escalation5.8.1 Field Troubleshooting & Repair5.8.2 Spare Parts5.8.3 Preventive Maintenance5.8.4 Escalation5.8.4.1 Escalation before Customer Solution Hand-over5.8.4.2 Escalation after Customer Solution Hand-over

5.8.5 Remote Service5.8.5.1 Remote Service by Agfa HealthCare

5.9 MIGRATIONS/UPGRADES5.10 COMMUNITY OF PRACTICE (CoP)

6 Training6.1 Training Path6.1.1 Strategy for DX-G trained Field Service Engineers (DX-G with TWAIN concept: software version below NIM_2000)6.1.1.1 Genrad6.1.1.2 Mammography

7 Documentation & Software7.1 Documentation7.2 Software Packages Titles & Download Locations

8 Service Agreements9 APPENDIX A Technical Specifications9.1 Typical Load9.2 Service Metrics and KPIs (Specified Target Values)9.3 Reliability (specified target values)

10 APPENDIX B Spare Parts Listings11 APPENDIX C Statements of Work11.1 Statement of Work Pre-Installation11.2 Statement of Work Installation11.3 Statement of Work Customer Training11.3.1 Handover of User Manuals11.3.2 Customer Training11.3.2.1 Training for Operating the Digitizer11.3.2.2 Training for Operating the ID Tablet11.3.2.3 Training for Usage of Detectors, Plates and Cassettes11.3.2.4 Performing further Activities depending on local Regulations

11.4 Statement of Work Corrective Maintenance11.5 Statement of Work Preventive Maintenance

12 Abbreviations

service dxm

Documents

dicom version

controlled version

document status

service strategy

service plan dxg dx

initial version

summary of service plan

service organization