General Electric CARDIOSOFT SERVICE MNL-VER6.6_SM_2040396-086_C Thermacare REF TC3003 Convective Warming System

Download

Page 1

GE Healthcare

CardioSoft

Version 6.6

Service Manual

2040396-086 Revision C

Page 2

NOTE: The information in this manual only applies to the CardioSoft Version 6.6. Due to continuing product innovation, specifications in this manual are subject to change without notice.

GE Medical Systems Information Technologies, Inc. 8200 West Tower Avenue Milwaukee, WI 53223 USA Tel: +1 414 355 5000

1 800 558 7044 (USA only) 1 800 668 0732 (Canada only)

GE Medical Systems Information Technologies GmbH Munzinger Straße 5 79111 Freiburg GERMANY Tel: +49 761 45 43-0 Fax: +49 761 45 43-233

Fax: +1 414 355 3790

CASE, MAC, MARS, and MUSE are trademarks owned by GE Medical Systems Information Technologies GmbH, a General Electric Company going to market as GE Healthcare.

T-2 CardioSoft FSM Revision C

2040396-086 2011-12-12

Page 3

Contents

1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

1.1 Manual Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1

1.1.1 Revision History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

1.1.2 Manual Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

1.1.3 Intended Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

1.2 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

1.2.1 Responsibility of the Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

1.2.2 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2

1.3 Warnings, Cautions, and Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3

1.4 Equipment Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

1.5 Service Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5

1.5.1 Service Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5

2 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

2.1 Installation of the Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

2.1.1 Installation of CardioSoft . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

2.1.1.1 Installation in the network . . . . . . . . . . . . . . . . . . . . . . . . . .2-1

2.1.1.1.1Network environment: Domain 1

2.1.1.1.2Network environment: Workgroup 4

2.1.1.2 Installation/Configuration of CardioSoft Web . . . . . . . . . . . 2-9

2.1.2 Installation of Communication Server . . . . . . . . . . . . . . . . . . . . . . . .2-13

2.1.3 General Entries in INI Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14

2.1.4 Entries in LOC_WIN.INI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14

2.1.5 Entries in CARDIO.INI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-19

2.1.6 Entries in SETUP_CM.INI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-20

2.1.7 Entries in CardioSoft.INI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-20

2.1.8 Entries in HL7.INI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21

2.1.9 Directory structure and notes on CardioSoft files . . . . . . . . . . . . . . . 2-22

2.1.10 System Configuration/Service screen . . . . . . . . . . . . . . . . . . . . . . . . 2-26

2.1.11 Data transfer to/from MUSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-27

2.1.12 Metabolic Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-30

2.1.12.1 Communication Commands . . . . . . . . . . . . . . . . . . . . . . . 2-30

2.1.12.2 Serial Port Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-30

2.1.12.3 Data String Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-31

2.1.12.4 Shared File Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-32

2.1.12.5 Data File Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-33

2.1.12.6 General Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-34

2.1.13 Configuration of "Complete Patient Information" . . . . . . . . . . . . . . . . 2-36

Revision C CardioSoft FSM 1

2040396-086

Page 4

2.2 Installation of the hardlock modules

(Parallel/serial & USB type) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-38

2.3 MARS PC Application Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-39

2.4 Configuring a CASE/CardioSoft System with the EMR Application . . . . 2-40

2.4.1 Before You Begin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-40

2.4.2 Configuring a CASE/CardioSoft System with the EMR Application . 2-42

2.4.3 Install the Centricity EMR Application . . . . . . . . . . . . . . . . . . . . . . . . 2-42

2.4.3.1 CASE/CardioSoft Interface Kit . . . . . . . . . . . . . . . . . . . . . 2-42

2.4.3.2 Import Clinical Kits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-42

2.4.3.3 Configure CASE/CardioSoft EMR Settings . . . . . . . . . . . . 2-42

2.4.4 Migrate Historical CardioSoft Data . . . . . . . . . . . . . . . . . . . . . . . . . . 2-43

2.4.4.1 Migrate Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-44

2.5 DICOM Interface Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-44

2.5.1 Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-44

2.5.2 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-44

2.5.3 Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-45

2.5.4 Special DICOM setup items without UI . . . . . . . . . . . . . . . . . . . . . . . 2-46

2.5.5 Protocol Code Mapping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-47

2.5.5.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-47

2.5.5.2 Method of Protocol Code mapping . . . . . . . . . . . . . . . . . .2-48

2.5.5.3 Syntax of the Protocol Code mapping per schema: . . . . . 2-48

2.5.5.4 Adding a new Protocol Schema . . . . . . . . . . . . . . . . . . . . 2-49

2.5.5.5 Default protocol schema and codes used in DICOM.INI .2-50

2.5.6 Description of dialogs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-54

2.5.6.1 DICOM tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-54

2.5.6.2 Network configuration - DSS/Order Filler, PPS Manager . 2-58

2.5.6.3 Network Configuration - Image Manager, Image Archive . 2-59

2.5.6.4 Worklist customization . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-60

3 Acquisition Modules for CardioSoft . . . . . . . . . . . . . . . . . 3-1

3.1 CAM-USB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

3.2 CAM-USB A/T & CAM-USB A/T KISS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5

3.3 CORINA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10

3.3.1 Context . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10

3.3.2 Supported Operating Systems and System performance . . . . . . . . . 3-10

3.3.3 Model 1 CORINA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10

3.3.4 Model 2 CORINA with Suction Pump . . . . . . . . . . . . . . . . . . . . . . . . 3-10

3.3.5 Model 3 CORINA with Analog Output . . . . . . . . . . . . . . . . . . . . . . . . 3-10

3.3.6 Model 4 CORINA with suction pump and Analog Output . . . . . . . . . 3-11

3.3.7 Replacement of CORINA Model 1...4 through newer CORINA Variants

(101 118 31...34) with enhanced communication interface to PC . . . . . . . . . 3-11

2 CardioSoft FSM Revision C

2040396-086

Page 5

3.4 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12

3.4.1 Repair Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12

3.5 Hardware Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13

3.5.1 Mechanical Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-13

3.5.1.1 Casing: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13

3.5.1.2 Floating screening: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14

3.5.1.3 PCB CORINA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16

3.5.1.4 Cable to PC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17

3.5.1.5 Pump Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17

3.5.1.6 PCB CORINA TRIGGER . . . . . . . . . . . . . . . . . . . . . . . . . 3-18

3.5.1.7 Insulation Foil for PCB CORINA TRIGGER . . . . . . . . . . . 3-18

3.5.1.8 Internal Wiring of the Analog Output . . . . . . . . . . . . . . . . . 3-19

3.5.2 Electrical and electronic structure . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19

3.5.2.1 ECG Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-19

3.5.2.2 CONTROLLER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-19

3.5.2.3 PC PORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21

3.5.2.4 Optional Analog Out Electronics . . . . . . . . . . . . . . . . . . . . 3-21

3.5.3 Internal Interfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-23

3.5.3.1 Mechanical Interfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23

3.5.3.2 Electrical Interfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23

3.5.4 Interfaces to Peripherals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-24

3.5.4.1 Mechanical Interfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-24

3.5.4.2 Electrical Interfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-24

3.6 Troubleshooting Help Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-27

4 Troubleshooting Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

4.1 Frequently Asked Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

4.2 Printer Debugging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9

4.3 General Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10

4.4 System Diagnosis with Windows XP / Vista . . . . . . . . . . . . . . . . . . . . . . . 4-14

4.5 Reprogramming Serial Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-14

4.6 Database Repair for CASE / CardioSoft / Card_Rep V6.x . . . . . . . . . . . . 4-16

4.6.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-16

4.6.2 Directory / File Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-16

4.6.2.1 CASE/CardioSoft directory structure . . . . . . . . . . . . . . . .4-16

4.6.2.2 Repair directory structure . . . . . . . . . . . . . . . . . . . . . . . . . 4-19

4.6.3 User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19

4.6.4 Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20

4.6.5 After Repair... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22

4.6.6 Specialities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23

Revision C CardioSoft FSM 3

2040396-086

Page 6

4.6.6.1 Merging data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23

4.6.6.2 Examinations stored on external media . . . . . . . . . . . . . . 4-23

4.6.6.3 Examinations with full disclosure ECG . . . . . . . . . . . . . . .4-23

4.6.6.4 Repair message codes . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24

4.6.6.5 Hidden functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25

4.7 Wireless LAN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-27

4.8 Remote Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-27

5 Supported Operating Systems . . . . . . . . . . . . . . . . . . . . . 5-1

6 Care and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

6.1 General introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

6.1.1 Recommended Test Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

6.1.2 Leakage Current Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-1

6.1.2.1 Enclosure Leakage Current Test . . . . . . . . . . . . . . . . . . . . 6-2

6.1.2.2 Patient Leakage Current Test . . . . . . . . . . . . . . . . . . . . . . . 6-3

6.1.2.3 Enclosure Leakage Current Test (System) . . . . . . . . . . . . . 6-3

6.1.2.4 Protective Earth Resistance Test . . . . . . . . . . . . . . . . . . . . 6-4

7 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

7.1 Technical Specifications for CAM-USB, CAM-USB A/T, CAM-USB A/T KISS

and CAM-14 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

7.2 Electromagnetic Compatibility of CAM-USB, CAM-USB A/T and CAM-USB A/

T KISS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3

7.3 Technical Specifications CORINA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-7

7.3.1 ECG Signal Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7

7.3.2 Analog Output Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7

7.3.3 Signal Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-8

7.3.4 Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8

7.3.5 Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8

7.3.6 Grounding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-9

7.4 Electromagnetic Compatibility of CORINA . . . . . . . . . . . . . . . . . . . . . . . . . 7-9

8 Spare Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

8.1 CAM-USB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

4 CardioSoft FSM Revision C

2040396-086

Page 7

8.2 CAM-USB A/T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2

8.3 CAM-USB A/T KISS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2

8.4 CORINA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-3

8.5 KISS Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4

8.6 Dongle CardioSoft Client and Web Server . . . . . . . . . . . . . . . . . . . . . . . . . 8-5

8.7 CardioSoft CDs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5

8.8 TONOPORT V/EasyOne-CS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5

8.9 Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5

Revision C CardioSoft FSM 5

2040396-086

Page 8

6 CardioSoft FSM Revision C

2040396-086

Page 9

1 Introduction

1.1 Manual Information

1.1.1 Revision History

Each page of the document has the document part number and revision letter at the bottom of the page. The revision letter identifies the document’s update level.

The revision history of this document is summarized in the table below.

Table 1. Revision History PN 2040396-086

Revision Date Comment

A 2009-09-15 Initial release of CardioSoft Service Manual V6.6.

B 2010-02-17 Changes on pages 1-5 and 8-1.

C 2011-12-12 Changes on page 1-5.

1.1.2 Manual Purpose

This manual supplies technical information for service representative and technical personnel so they can maintain the equipment to the assembly level. Use it as a guide for maintenance and electrical repairs considered field repairable. Where necessary the manual identifies additional sources of relevant information and or technical assistance.

See the operator manual for the instructions necessary to operate the equipment safely in accordance with its function and intended use.

1.1.3 Intended Audience

This manual is intended for the person who uses, maintains, or troubleshoots this equipment.

Revision C CardioSoft FSM 1-1

2040396-086

Page 10

Introduction: Safety Information

1.2 Safety Information

1.2.1 Responsibility of the Manufacturer

GE Healthcare is responsible for the effects of safety, reliability, and performance only if:

 Assembly operations, extensions, readjustments, modifications, or repairs are

carried out by persons authorized by GE Healthcare.

 The electrical installation of the relevant room complies with the requirements

of the appropriate regulations.

 The equipment is used in accordance with the instructions for use.

 The country of manufacture appears on the device label.

1.2.2 General

This device is not intended for home use.

Contact GE Healthcare for information before connecting any devices to the equipment that are not recommended in this manual.

Parts and accessories used must meet the requirements of the applicable IEC 60601 series safety standards, and/or the system configuration must meet the requirements of the IEC 60601-1-1 medical electrical systems standard.

Periodically, and whenever the integrity of the device is in doubt, test all functions.

The use of accessories not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include:

 use of the accessory in the patient vicinity and

 evidence that the safety certification of the accessory has been performed in

accordance to the appropriate IEC 60601-1 and/or IEC 60601-1-1 harmonized national standard.

If the installation of the equipment, in the USA, will use 240V rather than 120V, the source must be a center-tapped, 240V, single-phase circuit.

NOTE

The CORINA acquisition module is not for use in the U.S. and Canada.

1-2 CardioSoft FSM Revision C

2040396-086

Page 11

Introduction: Warnings, Cautions, and Notes

1.3 Warnings, Cautions, and Notes

The terms danger, warning, and caution are used throughout this manual to point out hazards and to designate a degree or level or seriousness. Familiarize yourself with their definitions and significance.

Hazard is defined as a source of potential injury to a person.

Term Definition

DANGER Indicates an imminent hazard which, if not avoided, will result in death or

serious injury.

WARNING Indicates a potential hazard or unsafe practice which, if not avoided, could

result in death or serious injury.

CAUTION Indicates a potential hazard or unsafe practice which, if not avoided, could

result in minor personal injury or product/property damage.

NOTE Provides application tips or other useful information to assure that you get

the most from your equipment.

Revision C CardioSoft FSM 1-3

2040396-086

Page 12

Introduction: Equipment Symbols

12V

1.4 Equipment Symbols

Caution, consult accompanying documents

Consult instructions for use

Type CF signal input, defibrillation-proof

Type BF signal input, defibrillation-proof

Mains power switch (ON - OFF)

On/Standby

Potential equalization pin

Protective earth terminal

Caution! High Voltage!

Signal input

Signal output

Fuse

12 V DC

The number found under this symbol is the date of manufacture in the YYYYMM format.

Medical Equipment — Classified with respect to electric shock, fire and mechanical hazards only in accordance with UL 60601-1/CAN/CSA C22.2 No. 601.1, CAN/CSA C22.2 No. 601-2-25, IEC 60601-2-25, IEC 60601-1-1.

Authorized representative in the European Community.

CE marked per the Medical Device Directive 93/42/EEC of the European Union.

Manufacturer’s identification

Order number

Serial number

1-4 CardioSoft FSM Revision C

2040396-086

Page 13

Introduction: Service Information

China RoHS pollution control label

Revision

This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.

China RoHS Mobius loop symbol

This symbol indicates that the device was tested and certified according to the Russian safety standards specified by GOST.

For use by or on the order of a physician, or persons licensed by U.S. law.

1.5 Service Information

1.5.1 Service Requirements

Follow the service requirements listed below.

 Refer equipment servicing to GE Healthcare’authorized service personnel only.

 Any unauthorized attempt to repair equipment under warranty voids that

warranty.

 It is the user’s responsibility to report the need for service to GE Healthcare or

to one of their authorized agents.

 Failure on the part of the responsible individual, hospital, or institution using

this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards.

 Regular maintenance, irrespective of usage, is essential to ensure that the

equipment will always be functional when required.

Revision C CardioSoft FSM 1-5

2040396-086

Page 14

For your notes

Introduction: Service Information

1-6 CardioSoft FSM Revision C

2040396-086

Page 15

2 Installation

2.1 Installation of the Software

After Software installation please reboot the system!

2.1.1 Installation of CardioSoft

For CardioSoft start the Setup Program without parameter. Versions earlier than V 4.2 first have to be upgraded to V 4.2 before installing V 6.x To run CardioSoft properly the screen resolution must be set to 1024 by 768 pixels or 1280 by 1024 pixels with 65536 (64 k) colors.

Note: Only CORINA Models 101 118 31...34 and 37/38 (OEM) are supported by CardioSoft 6.x.

2.1.1.1 Installation in the network

Network Configuration

To communicate with a MUSE server or Remote View Function you have to configure the TCP/IP protocol.

Network Installation of CardioSoft

CAUTION: Before installation close all programs (Case/Cardio) on all stations. If local CASEs/CardioSoft with existing examinations will be networked, perform a data backup before merging the databases as described below. The CardioSoft server itself must not be used as a CardioSoft station.

CAUTION: To guarantee trouble-free access to the database, be sure to install the latest CardioSoft sotware version on all CardioSoft clients/workstations in the network.

2.1.1.1.1 Network environment: Domain

A Setup Domain User

One of the following criteria must be met:

1. A new the Win2000/2003 domain where the CardioSoft server resides or a Win2000/ 2003 domain that has a trust relationship with the Win2000/2003 domain where the CardioSoft server resides. NOTE: Typically, the Domain Administrator must do this step

2. An existing CardioSoft server resides or an existing domain user from a Win2000/2003

domain user account must be created (designated as Network User) on

domain user account from the Win2000/2003 domain where the

Revision C CardioSoft FSM 2-1

2040396-086

Page 16

Installation: Installation of the Software

domain that has a trust relationship with the Win2000/2003 domain where the CardioSoft server resides is designated as the Network User configured to run the application on the CardioSoft system.

B Configure directory on CardioSoft-Server (see also diagram, page 2-8)

Select one of the following criteria and perform the according steps:

CardioSoft-Server: Network Share

1. On the computer designated as the CardioSoft server, create a directory on a local drive volume that meets the minimum space requirements for a CardioSoft database.

2. Network Share

a. For new installations, share this directory as “GE-cardio”.

b. For existing installations, use the existing share. Rename the existing

CardioSoft directory “cardio” to “card_old”. Create a new directory on a local drive volume that meets the minimum space requirements for a CardioSoft database

3. Configure the share permissions such that the designated Network User has “full control” permission.

4. If at least one local CASE/CardioSoft with existing examinations will be networked, additionally create a directory on the CardioSoft server for merging the databases later and share the directory as “DB_Merge” with “full control” permission.

2.1.2 Installation of Communication Server

The Communication Server is a separate PC with up to 4 Modems connected. Resting ECG procedures can be sent from ECG carts supporting A5 or CSI protocol to this Communication Server over a Modem. The Communication Server stores the Resting ECG's in a local network server and this data can be sent to the MUSE. Procedures can be sent from ECG Systems to this Communication Server over Modem.

Note: This PC can only used as Communication Server and cannot used for other purpose.

Prerequisites: PC with minimum requirement see CardioSoft User Manual, Up to 4 serial ports. Up to 4 Modems (CAUTION: all Modems must be from the same type), PC must be integrated in a local network to store the data or send the data to MUSE.

Installation Steps:

1. Install CardioSoft on the PC

2. Start the CardioSoft Application and view the System Configuration. In the Tab

Modem select the Baud Rate and the Modem Type (The Port Setting is not used for the Communication Server). In the Tab MUSE you can configure to send the Resting ECG's to MUSE (The setting “Start Modem connection before transfer” cannot be used). In the Tab General please deactivate the “Enable Password Function”.

3. For every Modem create a Shortcut to the CardioSoft Application. In the

Properties Dialog of the Shortcut view Tab Shortcut. For Modem 1 at COM1 change the content of the field “Target” to “...\cardio.exe cartmodem com1” (for Resting ECG from ECG recorder) or “...\cardio.exe sysmodem com1” (for Resting ECG from ECG System) and rename the shortcut to “CardioSoft Modem 1”. Change the other Shortcuts in the same way.

4. Connect all Modems and switch on all Modems. Start the first Shortcut. It

should be displayed a window with the title “COM1: Data received form ECG System/ECG recorder”. If an error message is displayed check the Modem Settings. Press the “End” Button in the window and close the CardioSoft Application. Test every shortcut in the same way.

5. Copy all Shortcuts to the Menu Group “Start up” with the Windows Explorer.

6. Close all applications and reboot the system.

With every start, up to 4 CardioSoft Applications are started and store the received Resting ECG's. If errors messages are displayed, then check the error like described in Step 4

Revision C CardioSoft FSM 2-13

2040396-086

Page 28

Installation: Installation of the Software

NOTE

Up to V5.02 the communication server assigned all received examinations, regardless of different patient demographic data. From V5.1 the default behaviour is diffent: examinations that have the same patient ID as stored on the local network server but different demographic data (last name, first name, date of bith), are copied to a list, to allow the customer later a manual assignment of this examinations. The comparison of patient demographic data is done case insentive, possible empty fields don’t care. The number of not assigned examinations is displayed. If the „End“-Button of any of the 4 windows is pressed, a dialog to assign manually all received examinations (that have not yet been assigned) comes up automatically.

If it is desired to assign all examinations automatically (as in versions <5.1), even if patient data are different, the entry „PAT_CommSrvTempList=0“ in LOC_WIN.INI section [CARDIO] must be inserted. Please note that patient demographic data in the examination is always updated with the patient data of the database (Resting ECGs).

2.1.3 General Entries in INI Files

All INI Files are in the Program Dirctory D:\CASE, C:\Cardio. Procedure Setups will be stored in CARDIO.INI. General settings will be stored in CA_SYS.INI and could be exported to any folder or floppy disc. Special service settings are stored in LOC_WIN.INI. When CardioSoft is started the first time and there is no CA_SYS.INI or no entry in this INI file the default values from the LOC_WIN.INI will be used and copied to the CA_SYS.INI file. After that the values from the CA_SYS.INI file are used.

2.1.4 Entries in LOC_WIN.INI

Entries from the file LOC_WIN.INI described here are mainly those which cannot be changed directly by changing settings in CardioSoft.

Describtion of the CARDIO section in the LOC_WIN.INI File

Font entries, screen settings, HF output ...

[CARDIO]

GRA_ScreenFont1 = “...” // Default = “MS Sans Serif” GRA_ScreenFont2 = “...” // Default = “Arial” GRA_ScreenFont3 = “...” // Default = “Courier New” GRA_ScreenFont4 = “...” // Default = “Small Fonts” GRA_ScreenFont5 = “...” // Default = “MS Sans Serif”

GRA_PrinterFont1 = “...” // Default = “Times New Roman” GRA_PrinterFont2 = “...” // Default = “Arial” GRA_PrinterFont3 = “...” // Default = “Courier New” GRA_PrinterFont4 = “...” // Default = “Small Fonts” GRA_PrinterFont5 = “...” // Default = “Times New Roman”

2-14 CardioSoft FSM Revision C

2040396-086

Page 29

Installation: Installation of the Software

CFG_ProdName = GE CardioSoft // Product name for CardioSoft

GE MicroLab // Product name for MicroLab GE CASE Client // Product name for CASE Client

CFG_CorinaTime = 5

CFG_Abcux = 2977 // 2978 or entry not available: USA version

// 2977: international version

CFG_ProgDir = C:\CARDIO // Program Directory CFG_DataDir = C:\CARDIO // Data Directory

CFG_SavedDataDir // Path to server database CFG_DispSwitchDBMsg // 0: disable message when database mode is

// changed // Default: 1

CFG_OfflineBackup // 1: save tests after sync. with online database in

// directory LOCAL_BACKUP // Default: 0

CFG_WorkOffline // Setting from user interface CFG_AutoWorkOffline // Setting from user interface

CFG_RemoveSpo2Device // 0: make legacy SpO2 devices visible in

// configuration // Default: 2

CFG_SerialNumber = CFG_UNCNameFor DataDrive=// UNC Name for Data Drive

CAUTION: If the file loc_win.ini is inadvertently deleted, only the USA version of CardioSoft can be started. It is thus advisable to make a backup of the INI files from time to time.

INST_DevType=0 // Device Type is set from the Installation Program

// 0: CardioSoft (is default if value not present) // 1: CardioSoft // 2: MicroLab // 3: CASE // 4: CASE Client // 5: CS

RES_ShowQTDispTable=? // Range of values: 0..1 Default: 1

// Meaning: Output of the QT data for all leads

in the measurement table

GRA_PrinterFontFactor=? // Range of values: 50..500 Default: 100

// Meaning: Font size factor for print fonts

GRA_ScreenFactor=? // Range of values: 50..500 Default: 100

// Meaning: Multiplication factor for screen

display fonts

Revision C CardioSoft FSM 2-15

2040396-086

Page 30

Installation: Installation of the Software

GRA_GridWeight=? // Range of values: 1..9 Default: 5

// Meaning: Grid points in printouts

GRA_CharSet=? // Range of values: 0..17 Default: 0

// Meaning: Determines the character set

for the CardioSoft fonts.

0: ANSI_CHARSET 1: DEFAULT_CHARSET 2: SYMBOL_CHARSET 3: SHIFTJIS_CHARSET

(Recommendation for Japanese) 4: OEM_CHARSET 5: BALTIC_CHARSET 6: CHINESEBIG5_CHARSET 7: EASTEUROPE_CHARSET 8: GB2312_CHARSET 9: GREEK_CHARSET

10: HANGUL_CHARSET 11: MAC_CHARSET 12: RUSSIAN_CHARSET 13: SYMBOL_CHARSET 14: TURKISH_CHARSET 15: JOHAB_CHARSET 16: HEBREW_CHARSET 17: THAI_CHARSET

GRA_PropSheetX = 100 // Default: 100

// Meaning: Scaling factor for the width of

“Property Sheets” like the Setup-Dialog

GRA_PropSheetY = 100 // Default: 100

// Meaning: Scaling factor for the hight of

“Property Sheets” like the Setup-Dialog

GRA_ScreenFont Factor=? // Range of values: 50..500 Default:100

// Meaning: Multiplication factor for screen

display fonts

GRA_Dlg SizeX = 100 // Default: 100

// Meaning: Scaling factor for the width of dialogs

GRA_Dlg SizeY = 100 // Default: 100

// Meaning: Scaling factor for the height of dialogs

PRI_CancelExe = ? // Range of values 0..1 Default = 1 for P2000 Printer

others = 0

PRI_GridColorR=? // Range 0..255, default=0 / red value of grid color

on printouts

PRI_GridColorG=? // Range 0..255, default=0 / green value of grid color

on printouts

PRI_GridColorB=? // Range 0..255, default=0 / blue value of grid color

on printouts

2-16 CardioSoft FSM Revision C

2040396-086

Page 31

Installation: Installation of the Software

MUS_SendComment=0 // Controls the comment + history objects to be sent

// to MUSE within the supplements object // Range 0..1, default=1 // 0: no objects // 1: comment + history

Some printer drivers have problems with aborting the print job. A seperate program CancelPr.Exe can be used to improve this behaviour.

GRA_DontRemoveGrid = 0 // Range of values 0..1 Default = 1

When CardioSoft is closed before all print layouts are finished, there may be problems with the grid. Setting this value to 1 causes the grid-font not to be removed when CardioSoft is closed.

CAMUSB_ImpedanceSlape = 115 // Meaning: for Impedance Measurement

CAMUSB_ImpedanceInterccpt = 2152 // Meanig: for Impedance Measurement

CAMUSB_LeadFailBias = 1 // Range of values 0..1 Default: 1

// Meaning: Enable lead Fail Detection

Some printer drivers have problems managing the printout area, so that the last line may be missing, for example. Where printing should start can be set as follows: PRI_FrameLeft=? // left-hand margin in 1/10 mm PRI_FrameTop=? // top margin in 1/10 mm

Mai_MoveMainWindow=? // Range of values 0..1 Default: 0

// Meaning: 1. The main window can be moved by clicking on the title bar in the initial screen // Meaning 0: The main window can not be moved

Mai_ResizeMainWindow=? //Range of values 0...1 Default: 0

Specifies if the main window can be resized to minimum 800x600 pixels

Mai_MainWindowPosition=left,top,width,height

// Position and size of the CardioSoft main window (in pixels) Example: Mai_MainWindowPosition:1024,0,1024,768 moves the main window to the 2nd screen of a dual screen system Note: Be sure to enter valid values. Otherwise you may not see the CardioSoft screen.

MUS_LosslessCompression=? // Range of values 0...1 Default: 1

Specifies that the 10 second ECG is sent to MUSE with our wihtout compression

FDA_InfoText=? // Range of values 0...1 Default = 1 for CardioSoft in

English and Spanish Specifies if the following text is shown on the Initial Screen or not:

CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician

Revision C CardioSoft FSM 2-17

2040396-086

Page 32

Installation: Installation of the Software

RES_GlobalValuesReadOnly=?//Range of values 0...1 Default: 0

Specifies if Measurement Results in Resting ECG / Post Text Review / Test Summary can be modified or not.

DSP_ClipCurves=? //Range of values 0...1 Default: 1

Specifies if the ECG curves are printed within the designated frame.

EMR_ErrDir=<error folder> The folder for error logging for the EMR Interface can be set individually for each client (System Configuration, EMR tab). If no value is specified, the default value is used: <Program folder>/emr_errors, i.e. D:\CASE\emr_errors or C:\CARDIO\emr_errors

EMR_MOde=1 If this entry does not yet exist, EMR mode is automatically enabled (=1) when starting CardioSoft, if the file emr.ini in c:\winnt\ with entry “LogicianInstallPathTo” in section “[Installation]” is available (which is automatically done with the Installation of the EMR system). Note that additionally the option XEMR is needed to run the EMR interface.

CFG_EnableEMR=0 The EMR mode can be switched off temporarily on the service screen. This is to have access to all functions for service purposes without the need to change EMR_MODE in LOC_WIN.INI manually. (So the entry EMR_Mode is not changed in this case).

PAT_CheckDemogr=? // Range of values 0...2 Default:1

//Meaning: If CardioSoft is launched by an external information system via HL7, BDT, or GDT, this entry defines the reaction, if the incoming patient ID is identical with the local database, but the patient demographic data (one of first name, last name or date of birth) are different.

0: No user interaction; If the incoming data field is not blank, the data is taken from the information system, else from the local database.

1: A side-by-side dialog comes up to select the patient demographic data to be used for the local database.

2: An error message comes up which must be confirmed. A new test cannot be performed.

PAT_RequirePatID=0 // Range of values: 0…1: Default: 1

Meaning: When CardioSoft is launched by an EMR (HL7, BDT, GDT), an existing Patient ID is mandatory and an error message comes up if no Patient ID was provided by the EMR. If set to zero, no error message occurs if no Patient ID is provided by the EMR. The patient record as well as the test is stored without Patient ID.

2-18 CardioSoft FSM Revision C

2040396-086

Page 33

Installation: Installation of the Software

CFG_TEMP_PATH_PDF=d:\temp// Default: ""

[CARDIO]

CFG_EXT_LOCATION_SOURCE=0// Range of values: 0…2; Default: 1

2.1.5 Entries in CARDIO.INI

CARDIO.INI stores the user dependent settings. In this chapter only those settings are described which cannot be changed directly by the CardioSoft application.

Meaning: Folder used when creating a synchronous temporary PDF output (for DICOM encapsulated PDF). The default value uses the "TMP"- or "TEMP"path variable as folder.

CardioSoft Source for Ergospirometry location used by LF8 (field "Ward"): 0: Not used 1: Room field 2: Location name configured in MUSE tab

[REST_ECG] PostTestPage=0

Controls the default tab appearing in Post Test Review of the resting ECG examination: default: 0 0 = Test Summary 1 = ECG Traces 2 = Medians 3 = Arrhythmia Review 4 = Vector Loops 5 = Full Disclosure

Color customization for Ambulatory Blood Pressure printouts [LBD_RECORD]

Remark: Header and footer are configured in the Printer Setup.

Format of the following items: R value (Red), G value (Green), B value (Blue)

Range: 0…255

Color of BP lines "Day" phase (affects Standard Page report format #1):

LBD_PriColLineDay=100,200,300 (Default: 0,255,0)

Color of BP lines "Night" phase (affects Standard Page report format #1):

LBD_PriColLineNight=100,200,300 (Default: 0, 0,128)

Color of Pulse Pressure lines "Day" phase (affects Standard Page report format #2):

LBD_PriColLinePPDay=100,200,300 (Default:0,0,0)

Color of Pulse Pressure lines "Night" phase (affects Standard Page report format #2):

LBD_PriColLinePPNight=100,200,300 (Default:0,0,0)

Color of area "Day" phase (affects Standard Page report format #2, Tabular Summary report, Histogram in Phases report)

LBD_PriColFlatDay=100,200,300 (Default: 255,245, 0)

Revision C CardioSoft FSM 2-19

2040396-086

Page 34

Installation: Installation of the Software

Color of area "Night" phase (affects Standard Page report format #2, Tabular Summary report, Histogram in Phases report):

LBD_PriColFlatNight=100,200,300 (Default: 166,202,240)

Color of Histogram (affects Statistic Summary report)

LBD_PriColFlatSum=100,200,300 (Default: 255,128, 0)

Color of upper limit area (affects Standard Page report format #3):

LBD_PriColFlatUpperLim=100,200,300 (Default: 255, 0, 0)

Color of lower limit area (affects Standard Page report format #3):

LBD_PriColFlatLowerLim=100,200,300 (Default: 0, 255, 0)

2.1.6 Entries in SETUP_CM.INI

This file is located in the program directory.

Option to set the sorting sequence of the alphanumerical key as required. Example: sort patients in reverse order; max. 255 characters permitted

[DATABASE] SortTable = “ZzYyXxWwVvUuTtSsRrQqPpOoNnMmLlKkJjIiHhGgFfEeDdCcBbAa”

This entry only comes into effect when made before calling up CardioSoft for the first time. The sorting sequence is stored in the database during its creation. If a change in the sorting sequence is to be made at some later time, the entire database has to be deleted.

[GENERAL] CFG_TEST_ATTACHMENTS=1 (Default: 0)

This item is automatically set to 1, when at least one workstation provides test attachments (e.g. Ergospirometry with LF8 reports). This is needed to control test attachment specific configuration items (e.g. for the Export dialog).

2.1.7 Entries in CardioSoft.INI

[Installation]

CardioSoft.ini is created by the EMR system and used by both, EMR and CardioSoft. It is stored in the folder <EMR install path>/CardioSoft. The following entries are used:

CARDIOPATH=<filepath> Specifies the full pathname of the CardioSoft executable (is filled and used by EMR):

READDIR=<dir path> CardioSoft output directory for car-files (Folder is automatically set by the EMR system and used by EMR and CardioSoft; It can be changed in CardioSoft, System Configuration, EMR tab, "Write to" folder):

WRITEDIR=<dir path> CardioSoft input directory for emr-files (Folder is automatically set by the EMR system and used by EMR and CardioSoft; It can be changed in CardioSoft, System Configuration, EMR tab, "Read from" folder):

2-20 CardioSoft FSM Revision C

2040396-086

Page 35

Installation: Installation of the Software

TESTMODE=<value> If value is TRUE then the CPO EMR will run in test mode. Test mode causes the HL7 files to be written with MSH-11 set to D (Debug) rather than the normal P (Production). Patient demographic data of simulated patient is used for all tests. Test mode should only be enabled for testing and should not be used in a production environment.

FILEHANDLING=<value> Specifies what should be done with files read or written (only used by EMR ). The value must be one of the following: 1. DELETE (default: car-files are deleted, emr-files are always deleted by CardioSoft). 2. MOVE (car-files and emr-files are saved to <readdir>/save and <writedir>/save)

2.1.8 Entries in HL7.INI

[GENERAL]

HL7.INI is used by Cardiosoft to setup the interface to the EMR system. The file is stored on the Cardiosoft server, so the items are valid for all clients. The following items are set by using the EMR tab in CardioSoft (System Configuration) by the user:

GEN_OutboundDir=c:\temp\inbound This is for the upload of existing patient and test records to the EMR database

GEN_TCPIP=0 Enable/Disable TCP/IP for the upload of existing patient and test records to the EMR database

GEN_HostName=DTSServer Hostname of DTS server (or IP address)

GEN_PortNrOut=34000 TCP/IP OUT port

GEN_Header=\011 Header for HL7 Low Level protocol

GEN_Trailer=\028\013 Trailer for HL7 Low Level protocol

The following settings can be entered manually in section [GENERAL] in HL7.INI (they are used with their default values)

GEN_ReqAckFromResponder=1 HL7 is used in Acknowledge mode (only with TCP/IP; default value is 0):

GEN_AckTimeout=1000 Timeout after an expected Acknowledge Message (only in Acknowledge mode) from the Responder in ms (default value is 2000ms, value is valid from 500 to 5000ms)

GEN_MaxSentMess=1 Total number of messages sent (default value is 2: original message and 1 repetition after error; value is valid from 1 to 5)

GEN_EndOfSegmWithCRLF=0 HL7 segments end with CR/LF (default is 1, that means all segments end with CR and LF; 0 means only CR)

Revision C CardioSoft FSM 2-21

2040396-086

Page 36

Installation: Installation of the Software

2.1.9 Directory structure and notes on CardioSoft files

Upon installation, CardioSoft creates a subdirectory (default: \CARDIO) where all files required for execution of the program are copied.

After the CardioSoft application has been started once, the following directories have been created. Database Directories (CardioSoft Default: C:\CARIO):

AVER Late Potential Examinations

CAS CASE8000 Examinations

DATABASE Btrieve File (e.g. database engine)

EMECG Emergency Examinations

EMRLINK HL7 files (links for EMR)

ERGOECG Stress tests

EXTPROG Reports from external programs

HOLTERRBP Ambulatory blood pressure files

NARRATIV Configured reports

ONL500 Full disclosure files for research (500Hz)

ONL2000 Full disclosure files for research (2000Hz)

ONLINE Full disclosure files for procedure types

RESTECG Resting ECG files

RHK Not in use

SETUP User settings

SOUND Test attachments

SPIR Spirometry Examinations

TAPE Not in use

After the CardioSoft application has been started once, following directories have been created. Program Directories (CardioSoft Default: C:\CARIO):

ATTACH Temp directory for test attachments (e.g. ergospirometry)

ConnSrv (Connectivity Server data directory, if installed)

DIAGS Thermal writer diagnostic software

DICOMLOG DICOM log and cache files

DOC User manuals and help files

emr_errors EMR log files

LOCAL_DB Database directory for offline mode

LOG CASE / CardioSoft event log files

PatientEducation Patient education files

RESTORE Restore folder due no network problems

WRITER Thermal writer Windows driver

The data base files containing the patient data and the references (file names) from the examinations are located in the directory \DATABASE. BTRIEVE is used as a data base. The examination data from operating modes resting ECG, spirometry, emergency and ergometry are stored in the directories \RESTECG, \SPIR,

2-22 CardioSoft FSM Revision C

2040396-086

Page 37

Installation: Installation of the Software

\EMECG, \ERGOECG, respectively. In all examinations online ECGs are stored In \ONLINE. Configurations are stored in the \SETUP directory.

Windows:

CASEsplashscreen.bmp

CaseStartup.bmp

CaseStartup_1152x864.bpm

CaseStartup_1280x1024.bpm

Windows\<Fonts Folder>:

GEInspBd.TTF

GEInspBI.TTF

Windows\inf:

Camusb.inf

MmsAcq_pci.inf

MmsUsbWriter.inf

Windows\System:

cor_vxd.vxd

hel_grid.ttf

Windows\System32:

CASE8000.cpl

Hel_grid.ttf

Mfc42.dll

MSFLXGRD.OCX

msvcp60.dll

Msvcrt.dll

Windows\System32\ drivers:

camusb.sys

COR_SYS.sys

Windows\System32\drivers\Case:

AcqKeypad.sys

btn_blk.sys

CardioMsg.dll

mmsacq_isa.sys

mmsacq_pci.sys

mmscom_isa.sys

mmscom_pci.sys

Revision C CardioSoft FSM 2-23

2040396-086

Page 38

Installation: Installation of the Software

mmsusb.sys

mtpd.sys

pgsusbsw.bix

PgsUsbWriter.sys

PgsUsbWriterLoader.sys

thermal_printer_fpga.bin

UsbWriter.sys

Windows\System32\drivers\Case\AcqFiles:

801284a.bin

acq_boot.bin

acq_brd.abf

acq_prog.abf

am114.m

bootldr.abf

ee_mgr.abf

eeboot.abf

main.abf

modldr.abf

Windows\System32\drivers\Case\inf:

Bimini_NT.inf

Case.inf

MmsAcq_isa.inf

MmsAcq_pci.inf

MmsAcqKeypad.inf

MmsBtn_isa.inf

MmsCom_isa.inf

MmsCom_pci.inf

MmsUsb.inf

MmsUsbWriter.inf

Mtpd.inf

P2000_NT.inf

P2000_XP.inf

PgsUsbWriter.inf

PgsUsbWriterLoader.inf

Radisys_NT.inf

Radisys_XP.inf

Windows\System32\drivers\Case\WriterFiles:

Chinese_GB2312.itf

Cyprwrtr.dld

EastEurope.itf

2-24 CardioSoft FSM Revision C

2040396-086

Page 39

Installation: Installation of the Software

Japanese.itf

Korean.itf

Latin1.itf

Russian.itf

Turkish.itf

Usbwrtr.dld

Windows\System32\drivers\spool\drivers\w32x86:

camusb.sys

COR_SYS.sys

File name nomenclature of the examination procedure

The file name comprises the ID letter for the examination procedure (C: Ergometry, R: Resting ECG, S: spirometry, N: STAT (emergency) ECG, A: late potential analysis, B: ambulatory blood pressure measurement, H: Holter ECG, U: ultrasound, T: stress echocardiography, Y: X-ray, K: cardiac catheterization, X: external programs, Z: Right-Heart-Catheterization), the identification letter for the compression (C: compressed, U: uncompressed), the internal patient ID (6-digit with leading zeros) and the internal examination ID (3-digit with leading zeros), giving additional file data.

File in windows inf directory: camusb.inf

INI files

An initialization file CARDIO.INI is created in the program directory, where the program settings are stored. These settings can be allocated with an identifier and stored in the help functions under Settings in the \SETUP directory, thus making them available to all users of a network (load help functions under Settings). Up to 10 settings can be stored. The file names are SETUP0.INI to SETUP9.INI. Stress test driver settings are stored in file PA5V0.DAT to PA5V9.DAT. Entries in the initialization files SYSTEM.INI and LOC_WIN.INI are described in the corresponding sections of this Service Maunual.

An initialization file CA_SYS.INI is created in the program directory, where the system settings are stored.

Stress test driver (ergometer, treadmill) settings are stored in the file ERG_PROT_V5AN.DAT in the program directory. If the profiles are modified or recreated, this file should be saved. It has been known for this file to have been deleted during new installations. It can also prove useful to assign the file with the attribute READONLY. This prevents overwriting or deletion. However, this attribute must be removed again before making any new changes in the profile. It is more advisable, however, to make a backup of the file as it cannot then be lost, even in the event of a hard disk error.

The initialization file HL7.INI is used for the EMR Interface created in the database directory. It is valid for all clients. For entries, see the corresponding section of this manual.

This initialization file CardioSoft.INI is created by the EMR system and is also used by CardioSoft.

Revision C CardioSoft FSM 2-25

2040396-086

Page 40

Installation: Installation of the Software

2.1.10 System Configuration/Service screen

The service screen is accessed in the General Settings via the “For Service” key. The password is helserv or case8k. This contains the logbook listing the errors arising during the run period since the last program start. One can delete the logbook or save it for future reference under a different file name.

Figure 2-1:

Service Screen Description

 Logbook: Displays internal logbook entries with time stamp

 Active: Activates the entries in the internal logbook. Can only be deactivated

until next program start

 Delete…: Deletes all entries in internal logbook.

 Save as…: Saves all entries of the internal logbook to a text file.

 OK or Cancel: Close the Service Screen

 Archive Path: Select on a CASE System the path to the archive A: (floppy

drive) or E: (CDROM drive). This Archive Path is only displayed if the password case8k was entered.

 CORINA time constant (HP filter): Time Constant for CORINA ECG

Acquisition Module. Should be not changed, if not requested from Customer.

 CAM14 High Pass Filter: High Pass Filter for CAM14 ECG Acquisition

Module. Should be not changed, if not requested from Customer.

 Research Full Disclosure ECG (in directory \ONL500, \ONL2000): Please

always select “non”. If you select other than “none” the hard disk will be filled up very fast, because for every Full Disclosure ECG a Full Disclosure ECG with 500 Samples per second or 2000 Samples per second will be stored.

2-26 CardioSoft FSM Revision C

2040396-086

Page 41

Installation: Installation of the Software

 CAM14 Disable Lead-Fail Bias: Disable Lead-Fail Bias for CAM14 ECG

Acquisition Module.

 ACQ TEST: Test of the CASE ECG Acquisition Module

 WRTR TEST: Test of the Thermal Writer

 KEYPAD TEST: Test of the CASE function keyboard

 BURN-IN TEST: Burn-In Test for CASE

 LOOPBACK TEST: Loop back test for CASE Serial ports

 Test dictionary…: Compares the Text Strings of the selected language with the

actual selected language of the system configuration.

 Service notice…: Service Person can write notice to a file.

 Set CAM-USB/CORINA Serial Number…: Set the CAM-USB or the CORINA

Serial number of a CAM-USB or CORINA from Service with Serial Number 0.

 Delete Network Locks…: All other stations of the network using this server

must be stopped before this Network Locks should be deleted.

 Save Log Files: Save the Log Files what have been activated from Engineering

and send this Log Files please to Engineering.

 Format Floppy: Formats a Floppy Disk.

2.1.11 Data transfer to/from MUSE

Store Examinations for MUSE

Prerequisites: Network with correct installed TCP/IP specifications,

or Modem and RAS with installed TCP/IP, assuming FTP or a shared directory will be used.

Each CardioSoft has to use the correct location number for generating an unique filename!

Tests on CardioSoft can be transferred to MUSE database for general accessibility Three possibilities are implemented in CardioSoft:

a) Save Examinations on Floppy and carry it to MUSE b) Send Examinations to MUSE using FTP via LAN or RAS c) Store Examinations on a shared directory located on MUSE via

LAN or RAS

The usual way for MUSE 5.x is FTP:

1. Specify the FTP account informations on CardioSoft -> System Configuration -> MUSE by enabling “Data transfer via FTP”

2. Type in the FTP Server (normally the same as the Web Server) Use Username and Password if this information is required for the FTP Server.

its unique Cart number as well as

For MUSE 4.x the prefered method will be the shared directory:

1. Specify the account informations on CardioSoft ->

System Configuration -> MUSE by enabling “Data transfer via shared directory”.

2. Type in the correct shared directory.

Use Username and Password if these informations is required for accessing this shared directory.

Revision C CardioSoft FSM 2-27

2040396-086

Page 42

Installation: Installation of the Software

Example: Use an existing mapped network drive (f.e. “F:\” as a synonym

for \\SvrName\SharePointName) already established from file manage reconnected at logon time (not available if using a modem!), or use the UNC Format in a valid form like “\\SvrName\SharePointName”. If no DNS/WINS is installed on the domain server (f.e. you're using RAS) write “\\123.456.789.255\SharePointName” (all samples without quotes!), where 123.456.789.255 is the physical

Transfering examinations to MUSE using FTP or shared directory, the connection to the server can be established via local modem. Enable “Start modem connection before transfering data” to use these RAS functionality. Note: You have to configure the modem, RAS, phonebook, etc. in a separate step.

IP address of the Server.

Modem/RAS Installation

Prerequisites: RAS access on MUSE-Server for required account.

Transfering Data from/to MUSE can be done via LAN or modem.

1. Select taskbar ->Start ->Settings ->Control Panel.

2. Doubleclick on “Modem” and follow the questions on the displayed dialogs.

Take attention in “Properties” ->“Call preferences” and disable “Wait for dial tone before dialing” if modem is linked in an Inhouse telephon compount.

3. Select taskbar ->Start ->Settings ->Control Panel.

4. Doubleclick on “Network”

5. Select Tab “Services”, add “Remote Access Service” and confirm by “OK”

6. Choose “TCP/IP” protocol in Properites ->Network

7. Select taskbar ->Start ->Programs ->Accessories ->Dial-Up Networking

Describe your connectivity to the MUSE server modem.

8. Behind Advanced... ->change properties ->Tab “Server” select the correct type

of server, protocol TCP/IP and the properties for this protocol

So far it's possible to establish a RAS connection for receiving patient and order information from MUSE, or for transfering examinations to MUSE.

(In advance you should confirm the configuration of RAS/Modem before you start a transfer in CardioSoft. Use explorer.exe or winfile.exe after establishing a connection to a PC via RAS, and try to down-/upload some files)

Example: The most problems occur with Dial-Up Networking ->Advanced... -

>change properties ->Tab “Entries” ->Configuration... ->Modem compression and in combination with ->Tab “Server” ->Software compression, as well as with “LCP-Extensions for PPP” and in Tab “Security” with the correct encryption/certification by using Service Packs before Version 3. The switches are dependent strongly on modem characteristics (on both sides) and on configuration of the integrated network with which you linked on it.

9. Connecting Internet Browser to MUSE via modem:

1. Select taskbar -> Start -> Settings -> Control Panel.

2. doubleclick on “Internet”.

3. Open tab “Connection”.

2-28 CardioSoft FSM Revision C

2040396-086

Page 43

Installation: Installation of the Software

4. Activate “Connect via modem”.

5. Confirm by “OK”

Patient database reading from MUSE

Prerequisites: Network with correct installed TCP/IP specifications

If you are using the MUSE database for selecting patients instead of the local database, you need an account on the MUSE server.

1. Specify the Web account informations on CardioSoft ->

System Configuration -> MUSE by enabling “Request MUSE data”.

2. Type in Web Server, the Username and the Password

3. Select the correct MUSE site number.

Example: For the MUSE servername specification you can use either the Internet

name convention “http:\\www.myMuseSvr....”, or the Intranet name

convention “myMuseSvr”, as well as a valid TCP/IP address in form of “123.456.789.255” (all samples without quotes!).

Configuration of Internet-Browser (IExplorer)

Reading stored examinations from MUSE database, CardioSoft requires an Internet Browser. Install IExplorer V6.0. Older versions as V4.01 (SP 2) of IE have some difficulties in working with MUSE.

Prerequisites: IExplorer V4.01 SP 2 or above

MUSE version 5.x or above Acrobat Reader V4.0 or above

1. Select taskbar -> Start -> Settings -> Control Panel.

2. doubleclick on “Internet”.

3. Open tab “Connection”.

4. Deactivate “Access via proxy server”, but this depents on the configuration of

the proxy server in your LAN. (if you have to use a proxy server, look furthermore in “Advanced Settings”).

5. Activate “Connect to Internet via LAN” if connection is caused by LAN,

otherwise activate “Connect via modem”.

6. Confirm by “OK”

Example: Some changes of MS IExplorer are working not before next restart of

the Operating System!

Revision C CardioSoft FSM 2-29

2040396-086

Page 44

Installation: Installation of the Software

2.1.12 Metabolic Interface

The system can communicate with the data acquisition device over the workstation’s serial port or it can record test data to a shared file on the network.

This section describes:

 the available communication commands

 the serial port settings

 the structure of the serial data string

 the structure of the test data file

 general settings

2.1.12.1 Communication Commands

To enable the serial port communication, select the “Metabolic Cart” checkbox in System Configuration -> Devices and select the appropriate COM port.

The stress test module can process the following commands from the serial port:

'E' echo on 'T' start treadmill 'O' stop treadmill 'H' stage hold 'R' request measurements 'W' start pretest 'S' start exercise 'M' start recovery

2.1.12.2 Serial Port Settings

The default settings for serial port are

parity no data bits 8 stop bits 1 baud rate 1200 handshake no

You can modify the settings for the serial port by modifying the following values in the [CAS_RECORD] section of the file <installation program folder>\CARDIO.INI.

Field Values

SpiroParity 0 = no parity

1 = even parity 2 = odd parity

SpiroDataBits 0 = 7 data bits

1 = 8 data bits

2-30 CardioSoft FSM Revision C

2040396-086

Page 45

Installation: Installation of the Software

Field Values

SpiroStopBits 0 = 1 stop bit

1 = 2 stop bits

SpiroBaudrate 0 = 300 baud

1 = 600 baud 2 = 1200 baud 3 = 2400 baud 4 = 4800 baud 5 = 9600 baud 6 = 19200 baud 7 = 38400 baud 8 = 56000 baud 9 = 128000 baud

SpiroHandShake 0 = no handshake

1 = XonXoff 2 = hardware handshake 3 = hardware handshake and interpretation of CR and NULL

For example, to configure the serial port for even parity, 7 data bits, 2 stop bits, 9600 baud, and XonXoff, cardio.ini would look like this:

[CAS_RECORD] SpiroParity = 1 SpiroDataBits = 0 SpiroStopBits = 1 SpiroBaudrate = 5 SpiroHandShake = 1

2.1.12.3 Data String Structure

If the system receives the "R" command (request measurements), the following data string is sent:

[AAAA_BBBB_C_DDDD_E_FFFF_GGGG_HHHH_IIII_JJJJ_KKKK_LLLL_M MMM_]NNPP where a space is shown as an '_'.

AAAA - Combined Phase and Stage name

BBBB - Value for load parameter 1 (value 0 if unavailable)

"base" - Pretest phase, stage 1 "warm"- Pretest phase, stage 2 or higher "ramp" - Exercise phase, all stages "reco" - Recovery phase, all stages

C - Designator for load parameter 1

M - Treadmill Speed in [0.1 mph] K - Treadmill Speed in [0.1 km/h] W - Ergometer Load in [W]

DDDD - Value for load parameter 2 (value 0 if unavailable)

Revision C CardioSoft FSM 2-31

2040396-086

Page 46

Installation: Installation of the Software

E - Designator for load parameter 2

% - Treadmill Grade in [0.1 percent] U - Ergometer revolutions in [/min] = [rpm]

FFFF - Heart rate in [/min] = [bpm] (value 0 if unavailable)

GGGG - Ventricular Ectopic beats per minute (VE/min)

HHHH - BP Measurement NBR (always -999 since not used)

IIII - Systolic BP in [mmHg] (-999 if unavailable)

JJJJ - Diastolic BP in [mmHg] (-999 if unavailable)

KKKK - ST Level for most significant ECG lead in [0.01 mV] = [0.1 mm] (-999 if unavailable)

LLLL - ST Slope for most significant ECG lead in [0.1 mV/s] (-999 if unavailable)

Remarks concerning the "most significant ECG lead":

 The most significant ECG lead is the lead with the largest ST-depression.

 The leads aVR, aVL and V1 are excluded.

 If no ST segment depression is found, lead V5 is defined as the most

significant lead.

MMMM - ST Integral for most significant ECG lead in [µVs] (-999 if anavailable)

NN - Rightmost 2 ASCII characters of checksum expressed hexadecimal in upper case

PP - Fixed string "CR" for Carriage return

2.1.12.4 Shared File Settings

The shared file otuput is enabled by the field “SpiroOptionWriteToFile”. If enabled, the system will write the stress test data to a shared file named ergospir.dat. By default, the file is stored in c:\temp. You can change that setting by modifying the following fields in the [CAS_RECORD] section of the file

<installation program folder>\LOC_WIN.INI.

SpiroOptionWriteToFile 0 = Do not write to file

SpiroDirectory Valid directory path

The checksum is the sum of the numeric values of all characters from "[" to "]" inclusive. (Example: Numeric value of character 'A' is 65).

Field Values

1 = Write to file

For example, if you want the shared file ergospir.dat to be written to a directory called spirapp\data located on the c:\ drive, the entry in LOC_WIN.INI would look like this:

2-32 CardioSoft FSM Revision C

2040396-086

Page 47

[CAS_RECORD] SpiroOptionWriteToFile = 1 SpiroDirectory = C:\SPIROAPP\DATA

2.1.12.5 Data File Structure

If the shared file output is enabled, the system will write the following data string to the shared file every five seconds or immediately after phase or stage has changed.

AAAA - Combined Phase and Stage name

BBBB - Value for load parameter 1 (value 0 if unavailable)

C - Designator for load parameter 1

Installation: Installation of the Software

"Chck" - Lead check phase, before start of Pretest "Base" - Pretest phase, stage 1 "Warm"- Pretest phase, stage 2 or higher "Exer" - Exercise phase, all stages "Reco" - Recovery phase, all stages "Stop" - Stress test was finished

M - Treadmill Speed in [0.1 mph] K - Treadmill Speed in [0.1 km/h] W - Ergometer Load in [W]

DDDD - Value for load parameter 2 (value 0 if unavailable)

E - Designator for load parameter 2

% - Treadmill Grade in [0.1 percent] U - Ergometer revolutions in [/min] = [rpm]

FFFF - Heart rate in [/min] = [bpm] (value 0 if unavailable)

GGGG - Ventricular Ectopic beats per minute (VE/min)

HHHH - BP Measurement NBR (always -999 since not used)

IIII - Systolic BP in [mmHg] (-999 if unavailable)

JJJJ - Diastolic BP in [mmHg] (-999 if unavailable)

KKKK - ST Level for most significant ECG lead in [0.01 mV] = [0.1 mm] (-999 if unavailable)

LLLL - ST Slope for most significant ECG lead in [0.1 mV/s] (-999 if unavailable)

Remarks concerning the "most significant ECG lead":

 The most significant ECG lead is the lead with the largest ST-depression.

 The leads aVR, aVL and V1 are excluded.

 If no ST segment depression is found, lead V5 is defined as the most

significant lead.

MMMM - ST Integral for most significant ECG lead in [µVs] (always -999 since not used)

Revision C CardioSoft FSM 2-33

2040396-086

Page 48

Installation: Installation of the Software

Meaning

NN - Rightmost 2 ASCII characters of checksum expressed hexadecimal in upper case

The checksum is the sum of the numeric values of all characters from "[" to "]" inclusive. (Example: Numeric value of character 'A' is 65).

PP - Fix string "CR" for Carriage return

Example

2.1.12.6 General Settings

For serial output and for shared file output:

The availability of the blood pressure values can be controlled by the following entries in the file <installation program folder>\LOC_WIN.INI:

ExerciseBpGreyoutTime:?

Range: 5..360, default = 60, unit = seconds The BP values will be greyed out after this period of time

2-34 CardioSoft FSM Revision C

SpiroNegateGreyedBp=?

Range: 0..2, default 1 BP values older than defined with entry ’ExerciseBpGreyoutTime’ will be converted as follows: 0: old BP value will be positive 1: old BP value will be invalid (-999)

2. old BP value will be negative

2040396-086

Page 49

Installation: Installation of the Software

2.1.13 Configuration of "Complete Patient Information"

When patient demographic data are provided externally, the "Complete Patient Information-Dialog" allows the user to complete missing patient demographic data, depending on the procedure type and the selected configuration.

The "Complete Patient Information-Dialog" can be used in the following scenarios:

(1) CardioSoft is launched by an EMR (HL7, BDT, GDT) to perform a new test.

(2) CardioSoft performs a new test via an order list (MUSE, DICOM)

(3) CardioSoft performs a new test via the MUSE patient list.

The following items can individually be enabled or disabled per procedure type Last name, first name, date of birth, weight, weight, gender, ethnic, pacemaker.

Sequence must be separated by a comma:

Last name, first name, date of birth, height, weight, gender, ethnic, pacemaker

Example

Configuration for External tests:

Configuration for Exercise test:

Configuration for Spirometry:

Configuration for Ambulatory Blood Pressure:

Configuration for HOLTER ECG:

: PAT_ComplDemogrSPI=1,0,1,1,0,1,0,0

PAT_ComplDemogrUNKNOWN=

Default for scenario (1): All items disabled Default for scenario (2) and (3): Enable Last name, date of birth

PAT_ComplDemogrCAS=

Default for scenario (1): All items disabled Default for scenario (2) and (3): Enable Last name, date of birth, gender

PAT_ComplDemogrSPI=

Default for scenario (1): All items disabled Default for scenario (2) and (3): Enable Last name, date of birth, height, gender

PAT_ComplDemogrABP=

Default for scenario (1): All items disabled Default for scenario (2) and (3): Enable Last name, date of birth

PAT_ComplDemogrLEG=

Revision C CardioSoft FSM 2-35

2040396-086

Page 50

Installation: Installation of the Software

Default for scenario (1): All items disabled Default for scenario (2) and (3): Enable Last name, date of birth enabled

Configuration for Resting ECG:

PAT_ComplDemogrRES=

Default for scenario (1):All items disabled Default for scenario (2) and (3): Enable Last name, date of birth, gender

Configuration for Ergospirometry:

PAT_ComplDemogrESP=

Default for scenario (1): All items disabled Default for scenario (2) and (3): Enable Last name, first name, date of birth, height, weight, gender

There are different 3 modes using this dialog:

(1) Mode 1

Activation of the dialog:

The dialog comes up if at least one item is enabled.

Display of the dialog:

Enabled items are displayed always. Disabled items are greyed out.

PAT_ComplDemogrIfEmptyFields=0 (default value for scenario (1))

(2) Mode 2

Activation of the dialog:

The dialog comes up if at least one item is enabled that is empty.

Display of the dialog:

Enabled items are displayed always, whether or not they are empty. Display a hint to indicate which of all enabled items that he has to complete because they are empty. Disabled items are greyed out.

PAT_ComplDemogrIfEmptyFields=1

(3) Mode 3

Activation of the dialog:

The dialog comes up if at least one item is enabled that is empty.

Display of the dialog:

All empty items are displayed, whether or not they were enabled. Display a hint to indicate which of the empty items he has to complete because they were enabled. All items that already have values are greyed out.

PAT_ComplDemogrIfEmptyFields=2 (default value for scenario (2) and (3))

2-36 CardioSoft FSM Revision C

2040396-086

Page 51

Installation: Installation of the hardlock modules (Parallel/serial & USB type)

2.2 Installation of the hardlock modules (Parallel/serial & USB type)

If CardioSoft is running without PATIENT MODULE, some of the options are locked with a hardlock. There are three hardlock modules available: One is the hardlock with ’DB 25 connectors. This hardlock can be connected to the parallel or the serial interface. Another USB hardlock can be connected to the USB port. When using this USB hardlock the hardlock has to be plugged into one free USB port of the PC. If a USB server hardlock module is connected to a USB port of a server, up to 250 CardioSoft without patient modules are enabled. An FLXX option activation key is required for this functionality. When using the parallel/serial hardlock, then using an environment variable the program can be informed where to look for the hardlock. In the default setting a search for the hardlock is made at the interfaces LPT1 and LPT2 only. In addition, using these environment variables, certain PC configurations, which could lead to problems, can be indicated.

Port Identification Meaning:

p = parallel normal parallel port

s = serial normal serial port

e = ECP parallel port in ECP mode

n = NEC (Japan) As the Japanese NEC models have a different port con-

figuration, a special operation can be activated with this parameter. A separate NEC API is thus no longer necessary.

C = Compaq Contura Dockingbase

I = IBM PS/2 The specification for IBM PS/2 rectifies an error in

Example:

in the file autoexec.bat

The hardlock is searched for at the parallel interface at address 0x378 and the serial interface at address 0x2f8.

The dockingbase multiplexer (to toggle between the parallel port and Ethernet adapter) is reset on the parallel port to scan for the hardlock.

reprogramming the ports for certain video drivers under Windows (hardlock is no longer found after Windows has been started). This effect can now only be activated via the specification of the environment variables.

SET HL_SEARCH=378p, 2f8s

If PATIENT MODULE is connected to LPT1, the hardlock at LPT2 may not be identified. In this case use

SET HL_SEARCH=278p

to inform hardlock API that the search for LPT2 should commence. The ports are generally located at the following addresses:

COM1 3F8

COM2 2F8

Revision C CardioSoft FSM 2-37

2040396-086

Page 52

Installation: MARS PC Application Configuration

COM3 3E8

COM4 2E8

LPT 1 378

LPT 2 278

Define the protocol used for accessing the HL Server.

Set HL_SERACH = IXP

IPX HL server searched for via IPX or SPX

OP HL server searched for via TCP/IP

NetBios HL server searched for via NetBios

IP is searched first by default.

(Optimize search via TCP/IP protocol.)

Set HLS_IPADRR = <server name>

For detailed information about installation of the server dongle, please refer to the Installation Guide.

For more hardlock details and how to use Alladin DiagnostiX, please refer to the Hardlock’s User Manual (see on CD, folder Hardlock Server).

2.3 MARS PC Application Configuration

If using MARS PC as the Holter ECG program, go to System Configuartion >Devices > Path to Holter ECG Program. Browse to the following path, where „drive:\“ is the driver letter whre MARS is installed: Drive:\gemsit\op\MarsNT\bin\superapp.exe

2-38 CardioSoft FSM Revision C

2040396-086

Page 53

Installation: Configuring a CASE/CardioSoft System with the EMR Application

2.4 Configuring a CASE/CardioSoft System with the EMR Application

NOTE

The term “CASE/CardioSoft” is used generically to denote whichever system is being configured, CASE or CardioSoft.

The CASE/CardioSoft system can be configured with the EMR application in the following configurations:

New CASE/CardioSoft System to EMR Existing CASE/CardioSoft System to EMR

1. Go through “Before You Begin” checklist.

2. Install Logician 5.6.3 or higher on each CASE / CardioSoft client. See “Configuring a CASE/CardioSoft System with the

EMR Application” on page 2-41.

3. Install the CASE/CardioSoft interface kit. See “CASE/CardioSoft

Interface Kit” on page 2-41.

4. Import the CardioSoft clinical kit to the EMR application. Follow the instructions in the CASE/CardioSoft - EMR Integration Release Notes.

5. Configure the CASE/CardioSoft EMR settings. See “Configure

CASE/CardioSoft EMR Settings” on page 2-41.

1. Go through “Before You Begin” checklist.

2. Install Logician 5.6.3 or higher on each CASE / CardioSoft client. See “Configuring a CASE/CardioSoft System with the

EMR Application” on page 2-41.

3. Install the CASE/CardioSoft interface kit. See “CASE/CardioSoft

Interface Kit” on page 2-41.

4. Import the CardioSoft clinical kit to the EMR application. Follow the instructions in the CASE/CardioSoft - EMR Integration Release Notes.

5. Configure the CASE/CardioSoft EMR settings. See “Configure

CASE/CardioSoft EMR Settings” on page 2-41.

6. Migrate Historical CASE/CardioSoft Data. This is a four-part process.

Refer to the instructions in the CASE/CardioSoft - EMR Integration Release Notes to: — Configure the Cross Reference File — CreateLinkLogic Relationships, and — Configure the LinkLogic Document Relationship.

Refer to “Migrate Data” on page 2-43 of this document to Migrate CASE/CardioSoft Data.

Before You Begin

Before using these instructions to configure the CASE/CardioSoft to EMR interface, go through this checklist.

CASE/CardioSoft System Installed

The CASE/CardioSoft system must be installed and operational prior to beginning to configure the CASE/CardioSoft to EMR interface.

 Use the procedures described in the CASE Service Manual for

configuring the CASE system.

Revision C CardioSoft FSM 2-39

2040396-086

Page 54

Installation: Configuring a CASE/CardioSoft System with the EMR Application

 Use the installation procedures described in the CardioSoft

Installation Guide for configuring the CardioSoft system.

 The CASE/CardioSoft database must reside in a shared location,

accessible to all users.

NOTE

GE recommends installing the CASE/CardioSoft database on a separate server from the EMR application. If you install it on the same server, GE recommends that it is on a separate, dedicated hard drive to ensure that file sizes do not hinder performance.

EMR Option Enabled on CASE/CardioSoft

The following requirements must be met for the EMR Option to be enabled on the CASE/CardioSoft system:

 The CASE/CardioSoft option code for the EMR application must be

entered in the System Configuration >> Option Codes tab PRIOR to configuring the EMR application on the CASE/CardioSoft system.

 The EMR option must be enabled in the System Configuration >>

General. Click For Service Only (service password: helserv) to display the Service Screen. Click Enable EMR-Mode.

Permissions for the EMR Application Web Site

You will need a User ID and password to access the EMR application’s support web site. Ask your EMR application manager for this information.

Instructions — CASE/CardioSoft – EMR Integration Release Notes

You will need the CASE/CardioSoft EMR Integration Release Notes for EMR-specific instructions for configuring the EMR application. The release notes can be found on the EMR support web site (http://support.medicalogic.com/).

EMR Application Installed

The EMR application must be installed and operational prior to beginning to configure the CASE/CardioSoft to EMR interface. For information on installing the EMR application, go to

http://support.medicalogic.com/, select your version of the product, and

then look under Installation Checklists.

Administrator Privileges

You will need administrator privileges to both the CASE/CardioSoft system and to the EMR application to complete this configuration. If you do not have administrator privileges, contact your system administrator.

Default Provider Name

The customer site administrator must designate the default provider for use before migrating historical data from the CASE/CardioSoft system to the EMR application.

2-40 CardioSoft FSM Revision C

2040396-086

Page 55

Installation: Configuring a CASE/CardioSoft System with the EMR Application

2.4.1 Configuring a CASE/CardioSoft System with the EMR Application

1. Set up the CASE/CardioSoft V6 in a networked environment.

Make sure that the XEMR option code for interfacing to the EMR application is available (in the CASE/CardioSoft system, click System Configuration, then the Option Code tab).

2. Install Logician 5.6.3 or higher on each CASE/CardioSoft client.

2.4.2 Install the Centricity EMR Application

2.4.2.1 CASE/CardioSoft Interface Kit

Install the CASE/CardioSoft Interface Kit. This is available for download/installation on the EMR application support website (http://support.medicalogic.com/).

2.4.2.2 Import Clinical Kits

Follow the instructions in the CASE/CardioSoft - EMR Integration Release Notes to import the CardioSoft clinical kit.

2.4.2.3 Configure CASE/CardioSoft EMR Settings

After importing the CASE/CardioSoft clinicial kit into the EMR application, verify on the CASE/CardioSoft system that the EMR settings are configured correctly.

1. Launch the CASE/CardioSoft application.

2. Click System Configuration. The System Configuration window displays.

Revision C CardioSoft FSM 2-41

2040396-086

Page 56

Installation: Configuring a CASE/CardioSoft System with the EMR Application

EMR tab

Communication folders

Error logging folder location

3. Verify that the EMR tab now is available onscreen.

CASE/CardioSoft System Configuration Setup Tab

NOTE

The Communication Folder locations were determined automatically after the EMR application was installed, using information from the file <EMR ApplicationInstallFolder>/ CardioSoft/CardioSoft.ini.

4. The folder for error logging is automatically generated. Verify that the folder location is accurate (i.e., for CardioSoft c:\ cardio\emr_errors, or for CASE: d:\case\emr_errors).

2.4.3 Migrate Historical CardioSoft Data

If you have been using CASE/CardioSoft prior to integrating with the EMR application, you’ll want to migrate your existing CASE/CardioSoft data. This migration transfers all of the data. You cannot selectively migrate only certain records. There are four steps to this migration:

1. Configure the Cross Reference File.

2. Create LinkLogic Relationships.

3. Configure the LinkLogic Document Relationship.

2-42 CardioSoft FSM Revision C

2040396-086

Page 57

2.4.3.1 Migrate Data

Installation: DICOM Interface Configuration

4. Migrate Data.

Follow the detailed instructions in the CASE/CardioSoft - EMR Integration Release Notes to configure the cross reference file, create LinkLogic relationships, and to configure the LinkLogic document relationship (steps 1 – 3 above). Refer to “Migrate Data” below to migrate historical data from the CASE/CardioSoft system to the EMR application.

To migrate the CASE/CardioSoft data, complete the following steps:

1. In the CASE/CardioSoft application, click System Configuration.

2. Select the EMR tab.

3. In the Data Transfer Via Shared Directory field, click the ellipsis and select the network LinkLogic installation of the ...Data\In folder.

4. Click OK.

5. Click Start.

A demographics file (.hd) and its related ImageLink files (.ht) are created for every patient in the CASE/CardioSoft database. These files are picked up by LinkLogic and included in the patent’s chart.

2.5 DICOM Interface Configuration

2.5.1 Terminology

IHE: Integrating the Healthcare Enterprise

DICOM: Digital Imaging and Communication in Medicine

SCP: DICOM Service Class Provider

SCU: DICOM Service Class User

PPS: Performed Procedure Step

DSS: Department System Scheduler

MWL: Modality Work List

AE title: Application entity title

2.5.2 General

The DICOM Interface is enabled with the option key DICM.

A valid DICM option key provides the DICOM tab in the System Configuration which allows you to configure the DICOM Interface.

The service password is needed to access the screen (see “System Configuration/

Service screen” on page 2-26).

Revision C CardioSoft FSM 2-43

2040396-086

Page 58

2.5.3 Setup

Installation: DICOM Interface Configuration

There are some items that affect the workflow/ User Interface of the system (e.g. work list configuration, archiving).

Those items should be reviewed with the clinical staff before using the systems.

The default setup is the setup recommended by the IHE Stress test profile.

To complete a standard IHE configuration the following steps are needed:

DICOM tab access

 Go to the System Configuration, select the DICOM tab and enter the service

password.

Perform local setup

On the DICOM tab, perform the following local setup (mandatory for each workstation):

NOTE

All data entered in this section is automatically stored in the local file CA_SYS.INI (section [DICOM]), located where the CARDIO application is installed.

 Enter the AE title for this workstation in the SCU AE title field.

Perform server-based setup

On the DICOM tab, perform the following server-based DICOM setup (done once, possible at any workstation if you have a CASE/CardioSoft network).

NOTE

All data entered in this section is automatically stored in the server-based file DICOM.INI, located where the database is installed.

 Enter the network configuration for DSS/Order Filler and PPS Manager (may

be identical to the Order Filler) using the button "Network Configuration" in the section "Worklist".

AE title, host name and port number of the remote host are required to complete this configuration.

Click both "Verify remote host" buttons to check the configuration (verification service, using ECHO Messages).

 Enter the network configuration for the Image Archive and Image Manager

(may be identical to the Image Archive) using the button "Network Configuration" in the section "Image Archiving".

AE title, host name and port number of the remote host are required to complete this configuration.

Click both "Verify remote host" buttons to check the configuration (verification service, using ECHO Messages).

The SCU port is used to receive storage commitment responses. Click the

2-44 CardioSoft FSM Revision C

2040396-086

Page 59

Installation: DICOM Interface Configuration

button "Verify SCU port" to check the configuration (verification service, using ECHO messages).

 Configure the extended character set for the DICOM Interface depending on the

language used: add the item CHARACTER_SET to “Special DICOM setup items without UI”).

Check the DICOM setup

 Click the "Check connection" button and verify that no error occurs.

 In case of errors, click "View error log..." and check the listed error message.

 Confirm the dialog.

Verify Order List button

 Click "New test" and verify that the "Order List" button is enabled in the patient

list dialog.

Verify the protocol code mapping

The CARDIO application receives protocol schema and codes from the DSS/ Order Filler and maps them to the internally used procedure types Exercise test, Resting ECG, Spirometry, Ambulatory Blood Pressure or Ergospirometry.

The protocol code mapping is responsible for starting the correct procedures out of the DICOM work list.

Therefore it is is crucial that the received and the used protocol schema and codes match.

To verify this, create at least one order per desired procedure type in the DSS/ Order Filler system.

Then bring up the Order List via patient list dialog.

Select each of the orders and verify that the "Start procedure" button is always active.

If this button is disabled for one of the orders, the corresponding protocol code mapping has to be modified.

The CARDIO application has implemented several sets of predefined protocol schema/codes (see chapter "Default protocol schema/codes").

Either the DSS/ Order Filler adapts it's used protocol schema/codes to this predefined schema/codes or the protocol code mapping has to be modified within this system (see chapter "Protocol Code Mapping").

2.5.4 Special DICOM setup items without UI

File DICOM.INI in database folder, section [DICOM]:

 Character set for the DICOM Interface:

The following extended character sets are supported:

CHARACTER_SET=0 (Default 0; range: 0 to 4)

Revision C CardioSoft FSM 2-45

2040396-086

Page 60

Installation: DICOM Interface Configuration

0: ISO_IR 6 (ASCII) 1: ISO_IR 100 (ISO 8859-1: Latin 1: Western European languages) 2: ISO_IR 101 (ISO 8859-2: Latin 2: Central/Eastern European languages) 3: ISO_IR 144 (ISO 8859-5: Cyrillic: Russian) 4: ISO_IR 148 (ISO 8859-9: Latin 5: Turkish)

 Use the selected ECG Report formats of the Exercise test setup for ECG

Waveform Images (only valid if the "General ECG Waveform SOP Class" is disabled and 12-leads are selected in the Exercise test setup):

IA_USE_SELECTED_ECG_REPORT_FORMATS=1 (Default: 0, use always 1x10s format)

 Timeout value for reading DICOM messages.

READ_MESSAGE_TIMEOUT=10 (Default: 5 seconds; Range: 1 to 100s)

 Transfer syntax for DICOM File Export.

FILE_TRANSFER_SYNTAX=1 (Default: 0; range 0 to 3)

0: Explicit Little Endian 1: Implicit Little Endian 2: Explicit Big Endian 3: Implicit Big Endian

 ECHO_INTERVAL for sending ECHO-RQ during “Verify remote host” action.

ECHO_INTERVAL_MS=1000 (Default: 2000; Range: 500 to 10000 ms)

 ECHO Retry Number for sending ECHO_RQ during “Verify remote host”

action.

ECHO_RETRY=5 (Default: 3; Range 1 to 20000)

2.5.5 Protocol Code Mapping

2.5.5.1 General

DICOM Protocol Codes are grouped in so called schemas.

There is a predefined DICOM protocol schema ("SRT") for Exercise test that CASE/CardioSoft uses as default data.

However, the DSS/Order filler may use other schemas and protocol codes.

In this case you can add or adjust schemas and protocol codes.

CASE/CardioSoft has also implemented it's own schema per procedure type that could be used by the DSS/Order filler.

The DICOM interface provides the Protocol Code Mapping in both directions:

Scheduled test (Incoming Protocol Codes)

Using the DICOM worklist, the received (scheduled) DICOM Protocol Schema/ Code is mapped to the

 CASE/CardioSoft Procedure Type (e.g. Exercise test, Resting ECG...) and to the

 CASE/CardioSoft Protocol Code I and II for detailed information

2-46 CardioSoft FSM Revision C

2040396-086

Page 61

Installation: DICOM Interface Configuration

(e.g. for Exercise test: Use of treadmill or ergometer. Use of protocol, e.g. BRUCE, WHO...).

If CASE/CardioSoft cannot find a corresponding procedure type, the "Start examination" button in the DICOM worklist is disabled.

Performed test (Outgoing Protocol Codes)

The DICOM Protocol Schema/Code sent out (Performed Protocol Schema/ Code) is built by using the performed

 CASE/CardioSoft Procedure Type (Exercise test, Resting ECG...) and the

 CASE/CardioSoft protocol code I and II for detailed information (e.g. for

Exercise test: Treadmill or Ergometer. Exercise test protocol, e.g. BRUCE, WHO...).

The DICOM Performed Protocol Code may be different than the DICOM Scheduled Protocol Code (but identical schema), because the user could have changed it.

Example:

The user startes a scheduled order, that initiates an Exercise test with a Treadmill and the BRUCE protocol.

Before going to the pre-test phase, the user switches to the NAUGHTON protocol.

So the DICOM Performed Protocol Code reflects what was executed in reality.

It is essential to have the correct Protocol Code Mapping in both directions.

2.5.5.2 Method of Protocol Code mapping

The DICOM Protocol Code Mapping is achieved by sections and entries in the file <Installation database folder>\DICOM.INI.

Changing or appending additional schemas for the mapping can only be done by manually changing the data in this file using an editor (e.g. Notepad).

Changes always affect all workstations and clients in the CASE/CardioSoft network.

The DICOM Protocol Schema/ Code applies to the DICOM tag 0040, 0008 (Scheduled Protocol Code Sequence) and 0040, 0260 (Performed Protocol Code Sequence).

2.5.5.3 Syntax of the Protocol Code mapping per schema:

Example: SRT_NO_0=STRESS,P2-7131C,1,BALKE

Four parameters are used per protocol code in a schema section.

The used delimiter is ",".

Revision C CardioSoft FSM 2-47

2040396-086

Page 62

Installation: DICOM Interface Configuration

1. CASE/CardioSoft Procedure Types: "STRESS" (Exercise test); "ABP" (Ambulatory Blood Pressure); "SPI" (Spirometry); "ECG" (Resting ECG); "ESPIRO" (Ergospirometry)

2. DICOM Performed Protocol Code: Depends on the used scheme. If a predefined DICOM schema is used, the protocol codes are well defined. If a user defined scheme used, it depends on the system’s requirements.

3. CASE/CardioSoft Protocol Code I (Value): Depends on CASE/CardioSoft Procedure Type For Exercise test/ Ergospirometry: 0 is Bicycle Ergometer, 1 is Treadmill For all other procedure types this is not yet used (= zero).

4. CASE/CardioSoft Protocol Code II (String): Depends on CASE/CardioSoft Procedure Type For Exercise test/ Ergospirometry: Protocol name that must match the Exercise test protocol names listed in the Exercise test configuration (e.g. "BRUCE"). For all other procedure types this is not yet used.

2.5.5.4 Adding a new Protocol Schema

Example for adding a new Protocol Schema including new Protocol Codes required by the DSS/Order Filler:

1. Determine the procedure type for which you want to add a new schema and use the corresponding test type identifier, e.g. Procedure type is Exercise test --- corresponding procedure type identifier is "STRESS".

2. Append the new schema for unscheduled tests in section [PROTOCOL_SCHEMES], using the item with the corresponding procedure type identifier, e.g. New schema is "ABCD": STRESS_PROT_SCHEME_UNSCHED=SRT,99IHE,CSO_STRESS,ABCD

3. Use the new schema as default protocol schema for the determined procedure type in section [PROTOCOL_SCHEMES], if the performed protocol code could not be mapped to a DICOM protocol code, e.g.

STRESS_PROT_SCHEME_USED_IF_UNKNOWN=ABCD

4. Determine DICOM default protocol codes for this schema, if the performed protocol code could not be mapped to a DICOM protocol code, e.g.

"ABCD_ERG_UNKNOWN", if CASE/CardioSoft Protocol Code I is 0 (Ergometer)

"ABCD_TRM_UNKOWN", if CASE/CardioSoft Protocol Code I is 1 (Treadmill)

5. Use the new DICOM Protocol Codes as required by the DSS/Order Filler for this procedure type, e.g.

"ABCD_WHO" for Ergometer with WHO-Protocol. "ABCD_BRUCE" for Treadmill with BRCUE-Protocol. Number of new DICOM Protocol Codes is 2.

6. Add the new schema as a new section, using the syntax as described, e.g.

2-48 CardioSoft FSM Revision C

2040396-086

Page 63

Installation: DICOM Interface Configuration

[ABCD] ABCD_UNKNOWN_0_PROT_CODE=ABCD_ERG_UNKNOWN ABCD_UNKNOWN_1_PROT_CODE=ABCD_TRM_UNKNOWN ABCD_NO=2 ABCD_NO_0=STRESS,ABCD_WHO,0,WHO ABCD_NO_1=STRESS,ABCD_BRUCE,1,BRUCE

2.5.5.5 Default protocol schema and codes used in DICOM.INI

[PROTOCOL_SCHEMES]

; List of protocol schemas per procedure type for the unscheduled case, max. 10 schemas allowed,

; delimiter is ","

STRESS_PROT_SCHEME_UNSCHED=SRT,99IHE,CSO_STRESS

ESPIRO_PROT_SCHEME_UNSCHED=SRT,99IHE,CSO_ESPIRO

ECG_PROT_SCHEME_UNSCHED=CSO_ECG

ABP_PROT_SCHEME_UNSCHED=CSO_ABP

SPI_PROT_SCHEME_UNSCHED=CSO_SPI

; Default performed protocol schema used, if the performed protocol code could not be

; mapped to a DICOM protocol code

STRESS_PROT_SCHEME_USED_IF_UNKNOWN=CSO_STRESS

ESPIRO_PROT_SCHEME_USED_IF_UNKNOWN=CSO_ESPIRO

ECG_PROT_SCHEME_USED_IF_UNKNOWN=CSO_ECG

ABP_PROT_SCHEME_USED_IF_UNKNOWN=CSO_ABP

SPI_PROT_SCHEME_USED_IF_UNKNOWN=CSO_SPI

[SRT]

; DICOM protocol scheme SRT for procedure type Exercise test

; list of defined protocol codes; first item must specify the number of protocol codes in this schema.

SRT_NO=9

SRT_NO_0=STRESS,P2-7131C,1,BALKE

SRT_NO_1=STRESS,P2-7131A,1,BRUCE

SRT_NO_2=STRESS,P2-7131D,1,ELLESTAD

SRT_NO_3=STRESS,P2-7131B,1,MODBRUCE

SRT_NO_4=STRESS,P2-713A1,1,MODNAUGHTON

SRT_NO_5=STRESS,P2-713A0,1,NAUGHTON

SRT_NO_6=STRESS,P2-7131F,1,PEPPER

SRT_NO_7=STRESS,P2-7131E,1,RAMP

SRT_NO_8=STRESS,P2-31102,0,WHO

[99IHE]

; DICOM protocol scheme 99IHE for procedure type Exercise test

Revision C CardioSoft FSM 2-49

2040396-086

Page 64

Installation: DICOM Interface Configuration

; list of defined protocol codes; first item must specify the number of protocol codes in this schema.

99IHE_NO=4

99IHE_NO_0=STRESS,PHARMSTRESS,1,MODBRUCE

99IHE_NO_1=STRESS,PERSANTINE,1,PERSANTINE

99IHE_NO_2=STRESS,ADENOSINE,1,ADENOSINE

99IHE_NO_3=STRESS,DOBUTAMINE,1,DOBUTAMINE

[CSO_STRESS]

; User defined protocol scheme for procedure type Exercise test

; outgoing default protocol codes for this scheme

CSO_STRESS_UNKNOWN_0_PROT_CODE=CSO_ERG_UNKNOWN

CSO_STRESS_UNKNOWN_1_PROT_CODE=CSO_TRM_UNKNOWN

; list of defined protocol codes; first item must specify the number of protocol codes in this schema.

CSO_STRESS_NO=21

CSO_STRESS_NO_0=STRESS,CSO_WHO,0,WHO

CSO_STRESS_NO_1=STRESS,CSO_WHO50,0,WHO50

CSO_STRESS_NO_2=STRESS,CSO_WHO75,0,WHO75

CSO_STRESS_NO_3=STRESS,CSO_HOLLMANN,0,HOLLMANN

CSO_STRESS_NO_4=STRESS,CSO_BAL,0,BAL

CSO_STRESS_NO_5=STRESS,CSO_STD.FRANCE,0,STD.FRANCE

CSO_STRESS_NO_6=STRESS,CSO_MODWHO,0,MODWHO

CSO_STRESS_NO_7=STRESS,CSO_CONCONI,0,CONCONI

CSO_STRESS_NO_8=STRESS,CSO_BRUCE,1,BRUCE

CSO_STRESS_NO_9=STRESS,CSO_MODBRUCE,1,MODBRUCE

CSO_STRESS_NO_10=STRESS,CSO_NAUGHTON,1,NAUGHTON

CSO_STRESS_NO_11=STRESS,CSO_ELLESTAD,1,ELLESTAD

CSO_STRESS_NO_12=STRESS,CSO_MODBALKE,1,MODBALKE

CSO_STRESS_NO_13=STRESS,CSO_USAFSAM,1,USAFSAM

CSO_STRESS_NO_14=STRESS,CSO_SLOWUSAFSAM,1,SLOWUSAFSAM

CSO_STRESS_NO_15=STRESS,CSO_CORNELL,1,CORNELL

CSO_STRESS_NO_16=STRESS,CSO_BALKE,1,BALKE

CSO_STRESS_NO_17=STRESS,CSO_MODBALKEWARE,1,MODBALKEWARE

CSO_STRESS_NO_18=STRESS,CSO_ADENOSINE,1,ADENOSINE

CSO_STRESS_NO_19=STRESS,CSO_DOBUTAMINE,1,DOBUTAMINE

CSO_STRESS_NO_20=STRESS,CSO_PERSANTINE,1,PERSANTINE

[CSO_ESPIRO]

; User defined protocol scheme for procedure type Ergospirometry test

; outgoing default protocol codes for this scheme

CSO_ESPIRO_UNKNOWN_0_PROT_CODE=CSO_ERG_UNKNOWN

2-50 CardioSoft FSM Revision C

2040396-086

Page 65

Installation: DICOM Interface Configuration

CSO_ESPIRO_UNKNOWN_1_PROT_CODE=CSO_TRM_UNKNOWN

; list of defined protocol codes; first item must specify the number of protocol codes in this schema.

CSO_ESPIRO_NO=21

CSO_ESPIRO_NO_0=ESPIRO,CSO_E_WHO,0,WHO

CSO_ESPIRO_NO_1=ESPIRO,CSO_E_WHO50,0,WHO50

CSO_ESPIRO_NO_2=ESPIRO,CSO_E_WHO75,0,WHO75

CSO_ESPIRO_NO_3=ESPIRO,CSO_E_HOLLMANN,0,HOLLMANN

CSO_ESPIRO_NO_4=ESPIRO,CSO_E_BAL,0,BAL

CSO_ESPIRO_NO_5=ESPIRO,CSO_E_STD.FRANCE,0,STD.FRANCE

CSO_ESPIRO_NO_6=ESPIRO,CSO_E_MODWHO,0,MODWHO

CSO_ESPIRO_NO_7=ESPIRO,CSO_E_CONCONI,0,CONCONI

CSO_ESPIRO_NO_8=ESPIRO,CSO_E_BRUCE,1,BRUCE

CSO_ESPIRO_NO_9=ESPIRO,CSO_E_MODBRUCE,1,MODBRUCE

CSO_ESPIRO_NO_10=ESPIRO,CSO_E_NAUGHTON,1,NAUGHTON

CSO_ESPIRO_NO_11=ESPIRO,CSO_E_ELLESTAD,1,ELLESTAD

CSO_ESPIRO_NO_12=ESPIRO,CSO_E_MODBALKE,1,MODBALKE

CSO_ESPIRO_NO_13=ESPIRO,CSO_E_USAFSAM,1,USAFSAM

CSO_ESPIRO_NO_14=ESPIRO,CSO_E_SLOWUSAFSAM,1,SLOWUSAFSAM

CSO_ESPIRO_NO_15=ESPIRO,CSO_E_CORNELL,1,CORNELL

CSO_ESPIRO_NO_16=ESPIRO,CSO_E_BALKE,1,BALKE

CSO_ESPIRO_NO_17=ESPIRO,CSO_E_MODBALKEWARE,1,MODBALKEWARE

CSO_ESPIRO_NO_18=ESPIRO,CSO_E_ADENOSINE,1,ADENOSINE

CSO_ESPIRO_NO_19=ESPIRO,CSO_E_DOBUTAMINE,1,DOBUTAMINE

CSO_ESPIRO_NO_20=ESPIRO,CSO_E_PERSANTINE,1,PERSANTINE

[CSO_ECG]

; User defined protocol scheme for procedure type Resting ECG

; outgoing default protocol codes for this schema

CSO_ECG_UNKNOWN_0_PROT_CODE=CSO_ECG_UNKNOWN

; list of defined protocol codes; first item must specify the number of protocol codes in this schema.

CSO_ECG_NO=1

CSO_ECG_NO_0=ECG,CSO_ECG,0,Resting ECG

[CSO_ABP]

; User defined protocol scheme procedure procedure type Ambulatory Blood Pressure

; outgoing default protocol codes for this schema

CSO_ABP_UNKNOWN_0_PROT_CODE=CSO_ABP_UNKNOWN

Revision C CardioSoft FSM 2-51

2040396-086

Page 66

Installation: DICOM Interface Configuration

; list of defined protocol codes; first item must specify the number of protocol codes in this schema.

CSO_ABP_NO=1

CSO_ABP_NO_0=ABP,CSO_ABP,0,ABP-Test

[CSO_SPI]

; User defined protocol scheme for procedure type Spirometry

; outgoing default protocol codes for this schema

CSO_SPI_UNKNOWN_0_PROT_CODE=CSO_SPI_UNKNOWN

; list of defined protocol codes; first item must specify the number of protocol codes in this schema.

CSO_SPI_NO=1

CSO_SPI_NO_0=SPI,CSO_SPI,0,Spirometry-Test

;The user can add other protocol schemas or change existing protocol schemas as needed, but the required syntax must be followed.

2-52 CardioSoft FSM Revision C

2040396-086

Page 67

Installation: DICOM Interface Configuration

2.5.6 Description of dialogs

2.5.6.1 DICOM tab

Figure 1

1. Acquisition modality (configuration affects this workstation)

a. SCU AE-title (Unique ID for this workstation, mandatory)

b. Modality for the worklist query (Default: Orders for modality "ECG")

c. Own Modality (Default: "ECG")

2. Workli st (configuration affects all workstations in the CASE/CardioSoft network)

a. DICOM Work list function (Default: Enabled)

If the Work list function is disabled, the system does not connect to the DSS/Order Filler and the PPS Manager at all. Only the Image Archiving is done, if it is enabled.

b. Network Configuration

See description Figure 2

c. Worklist Customization

See description Figure 4

d. DICOM Source for the Order number (part of the test information):

Revision C CardioSoft FSM 2-53

2040396-086

Page 68

Installation: DICOM Interface Configuration

• Accession number (0008,0050)

• Requested Procedure ID (0040,1001)

• Scheduled Procedure Step ID (0040,0009)

• Not used (blank)

e. Default procedure type for starting the test if the scheduled protocol code

did not match:

• Exercise test

• Resting ECG

• Spirometry

•ABP

• Ergospirometry

• Not used

3. Service support

a. Check the DICOM-Interface according to the DICOM configuration setup:

The following checks are implemented:

•DICOM library (Merge3-COM) initialization

• "Open Association" and "Close Association" action to the DSS/Order filler is performed, if the work list is enabled; the Service List [DMWL_Service_List] in file MERGECOM.APP is used for association negotiation.

• "Open Association" and "Close Association" action to the PPS Manager is performed, if the work list is enabled; the Service List [MPPS_Service_List] in file MERGECOM.APP is used for association negotiation.

• "Open Association" and "Close Association" action to the Image Archive is performed, if one of the TCP/IP functions for image archiving is enabled and the ECG Waveform object is enabled and the "General ECG Waveform Object SOP Class" is disabled; the Service List [IA_Service_List_12LECG] in file MERGECOM.APP is used for association negotiation.

• "Open Association" and "Close Association" action to the Image Archive is performed, if one of the TCP/IP functions for image archiving is enabled and the ECG Waveform object is enabled and the "General ECG Waveform Object SOP Class" is enabled; the Service List [IA_Service_List_GenECG] in file MERGECOM.APP is used for association negotiation.

• "Open Association" and "Close Association" action to the Image Archive is performed, if one of the TCP/IP functions for image archiving is enabled and the PDF Report object is enabled; the Service List [IA_Service_List_EncPDF] in file MERGECOM.APP is used for association negotiation.

• "Open Association" and "Close Association" action to the Image Manager is performed, if one of the TCP/IP functions for image archiving is enabled and the "Storage Commitment Request" is enabled; the Service List [IM_Service_List] in file MERGECOM.APP is used for association negotiation.

The results are logged in the file "<Installation_ProgramFolder>\DICOMLOG\DicomLog.txt".

b. View error log

The DICOM-Interface logs its events using 3 files:

2-54 CardioSoft FSM Revision C

2040396-086

Page 69

Installation: DICOM Interface Configuration

• <Installation Program folder>\DICOMLOG\DicomLog.txt (viewed automatically by using this button; includes the most DICOM-Interface events)

• <Installation Program folder>\DICOMLOG\DicomLogThread.txt (can only be manually displayed; includes events logged by the DICOM Listener Thread)

• <Installation Program folder>\Merge.log (this comes from the DICOM MergeCOM-3 library (is not considered here).

The DICOM-Interface uses 2 levels of event logging.

The default event logging level is level 0, which is used for errors.

Changing the level to level 1 has the following effect:

• Adds more informations (that are not necessarily errors) to the log files

• Lists the DICOM messages of one transaction as files in the DICOM LOG folder

To change the event logging level, use the Notepad to edit the file CA_SYS.INI in program folder, section [DICOM], entry DICOM_LOG_LEVEL=1.

c. Local usage of the DICOM setup:

• Use the server-based DICOM setup (default). In a CASE/CardioSoft network all workstations use one server-based DICOM setup.

• Use local DICOM setup. In a CASE/CardioSoft network you can switch the server-based DICOM setup of this workstation to a local setup that affects only this workstation.

4. Image Archiving (configuration affects all workstations in the CASE/ CardioSoft network)

a. Set the test to "Read only" in the database after a successful image

archiving (when the test was set to "Archived (DCM)" in the test list).

NOTE

Archiving occurs at different times, see 4i

b. File export folder configuration for automatic or manual image archiving

via file export (UNC is supported)

c. Image archiving includes the PDF report of the test (report format is as

configured for the print report in the modality)

d. Image archiving includes the following raw ECG Waveforms of the

Exercise test:

• The first 12SL ECG strip in pretest phase (as "Resting ECG"), if available.

• The last ECG strip in pretest phase (as "Baseline ECG"), if available.

• The last ECG strip per stage in exercise phase (as "Exercise ECG"), if available.

• The last ECG strip in recovery phase (as "Post Exercise ECG"), if available.

e. Use the "General ECG Waveform SOP Class" for archiving ECG

Waveforms (instead of "12-Lead ECG Waveform SOP Class"): There may be two scenarios to enable this item:

Revision C CardioSoft FSM 2-55

2040396-086

Page 70

Installation: DICOM Interface Configuration

• The Image Archive cannot process/view the DICOM 12-lead ECG Waveform object.

• The Exercise test is perfomed with 3-, 6- or 15 leads.

f. Enable "Storage Commitment transaction"

Some Image Managers may not have the ability to process the "Storage Commitment transaction". In this case uncheck this item.

g. Network configuration (see section “Network Configuration - Image

Manager, Image Archive” on page 2-58)

h. Function of automatic image archiving

The following functions are available for the automatic image archiving:

• Perform the automatic archiving via TCP/IP (default; uses the Image Archive SCP configuration and the Image Manager SCP configuration, see 4g)

• Perform the automatic archiving via File Export. The destination folder of 4b is used. The file name is used as configured in the Export setup dialog (see User Manual, System Configuration)

• Disable the automatic archiving

i. Start automatic image archiving

• Initiate the archiving of a test automatically after Test Execution

• Initiate the archiving of a test automatically after Test Confirmation

j. Repeat automatic image archiving after a test modification.

A test modification after archiving it is only possible, if the test was not yet set to "Read Only" (see 4a).

k. Function of manual image archiving

Manual image archiving is not intended for the normal workflow. It is accessible through a button in the test list, if it was enabled here. One or more tests can be selected and be archived manually. The following functions are available for the manual image archiving:

• Perform the manual archiving via TCP/IP (uses the Image Archive SCP configuration and the Image Manager SCP configuration, see 4g)

• Perform the manual archiving via File Export (uses the destination folder of 4b and the filename as configured in the Export setup dialog, see User Manual, System Configuration)

• Disable the manual archiving (default)

l. Use not yet archived tests for manual image archiving

Archive all tests or only tests, that were not yet archived.

m. Use reviewed (confirmed) tests for manual image archiving

Archive all tests or only tests, that were reviewed before.

2-56 CardioSoft FSM Revision C

2040396-086

Page 71

Installation: DICOM Interface Configuration

2.5.6.2 Network configuration - DSS/Order Filler, PPS Manager

Figure 2

The following data are stored server-based (unless local storage was explicitly set in the configuration) accessible for all CASE/CardioSoft Workstations and Clients (file DICOM.INI in Database folder):

a DSS/Order filler SCP AE Title

b DSS/Order filler SCP IP/Host name

c DSS/Order filler SCP Port number

d DSS/Order filler verify remote host

e PPS Manager SCP AE Title

f PPS Manager SCP IP/Host name

g PPS Manager SCP Port number

h PPS Manager verify remote host

Revision C CardioSoft FSM 2-57

2040396-086

Page 72

Installation: DICOM Interface Configuration

g j

2.5.6.3 Network Configuration - Image Manager, Image Archive

Figure 3

a Image Manager SCP AE Title

b Image Manager SCP IP/Host name

c Image Manager SCP Port number

d Image Manager SCU Port number (for Storage commitment responses)

e Image Manager verify remote host

f Image Manager verify reception on SCU port

g Image Archive SCP AE Title

h Image Archive SCP IP/Host name

i Image Archive SCP Port number

j Image Archive verify remote host

2-58 CardioSoft FSM Revision C

2040396-086

Page 73

Installation: DICOM Interface Configuration

2.5.6.4 Worklist customization

Figure 4

The worklist customization dialog allows to customize the following fields in the DICOM worklist:

1. Worklist fields (correspond to the last column in the DICOM worklist)

2...7.Six detailed information fields (correspond to the fields in the detailed information section of the DICOM worklist)

They are made up of identical elements

a. Check box: allows you to enable or disable the corresponding field in the

DICOM worklist.

b. Drop-down list: available DICOM data object to select

c. Text box for entry of the DICOM data object prompt

d. Use default text button to restore the default text prompt for the selected

DICOM data object

8. Worklist Default button to reset all fields of the DICOM worklist to their default values.

Revision C CardioSoft FSM 2-59

2040396-086

Page 74

Installation: DICOM Interface Configuration

2-60 CardioSoft FSM Revision C

2040396-086

Page 75

3 Acquisition Modules for

3.1 CAM-USB

CardioSoft

CAM-USB is a 15-lead ecg acquisition device with USB interface. It consists of two main parts, the CAM-14 acquisition module and the CAM-USB Interface box. Only additionally lead wires and electrode grabbers are needed to complete the system hardware for the CAM-USB (see Figure 3-1).

Figure 3-1:

Supported PC and Operating Restrictions

The CAM-USB system is allowed to be connected to the USB port of any PC certified according IEC950.

 The PC must not be within the patient care area in accordance with IEC 60601-1.

 The CAM-USB system may only be connected directly to a PC USB PORT. It is

not allowed to use any USB-HUB or cable extension between PC and the CAMUSB system

 Because the CAM-USB device is powered directly from the USB bus, care must

be taken with the connection of other bus-powered USB devices to assure full USB single port operating power (+ 5V DC, 500 mA) for the CAM-USB system.

Revision C CardioSoft FSM 3-1

2040396-086

Page 76

Acquisition Modules for CardioSoft: CAM-USB

Supported Operating Systems and System Performance

CAM-USB and CardioSoft V6.x are working with

a) Windows XP Professional 32-bit (SP2 or SP3)

Recommended PC (P4 class): 1.6 GHz min., 512 MB SDRAM min., 20 GB HDD min.

b) Windows Vista Home Premium 32-bit (SP1 or SP2)

Windows Vista Business 32-bit (SP1 or SP2))

Recommended PC (P4 class): 2GHz min., 1 GB SDRAM, 20 GB HDD min.

CAM-14 Acquisition Module

(P/N: 901142 - 005, 901142 - 008)

Functions

15-lead acquisition module , already used with CASE8000, CASE and MAC5000

Interface

Serial digital communication interface with 1 MHz clock

CAM-USB Interface

(P/N: 2009000 - 001)

Functions

The CAM-USB INTERFACE implements the function of the protocol converter between the PC-USB communication port and the patient data acquisition module CAM-14. It is used to isolate the PC-System from the Patient environment with a 4kV medical floating isolation. It also generates the operating voltage for the CAM-14 module. (see Figure 3-2)

Interfaces USB Interface: PC Communications Bus (12 MHz full-speed device,

bus powered)

CAM-14 Interface: Serial two wire protocol with 1 MHz serial clock.

Figure 3-2:

3-2 CardioSoft FSM Revision C

2040396-086

Page 77

Acquisition Modules for CardioSoft: CAM-USB

Indicators

The CAM-USB Interface has two LED's (LED A, yellow and LED B, green) to display the actual CAM-USB interface status. Additional there is a buzzer to allow any acoustically signalling and the QRS beep (if enabled within the CardioSoft software).

Meaning of the system status LEDs

green LED yellow LED system status

ON OFF ECG signal transmission in pro-

gress

ON ON ready to send ECG signals

(e.g., no communication with

CAM-14)

OFF OFF no power

ON blinking communication with CAM-14 in-

terrupted

(e.g., CAM-14 not connected)

When a communication problem between the CAM-USB Interface Box and the PC occurs, the box will emit a continuous tone and both LEDs will be illuminated.

CAM-USB Interface defects handling

According to the actual service strategy, there will be no repair of the CAM-USB Interface. In the case of defect, the complete box (with mounted cables) will be exchanged. Only the two cables could be exchanged (see Spare Parts, chaper 8).

Reprogram the serial number after box exchange, see herefore chapter 4.5 Reprogramming Serial Number.

Revision C CardioSoft FSM 3-3

2040396-086

Page 78

Acquisition Modules for CardioSoft: CAM-USB

158

30±2

8±2

2013023-001

USB

Gehaeuse ohne Bedruckung dargestellt

Casing shown without printing

2009590-001

2:1

2007913-001

801 777 25

scr f. plastic-3x6 panhead

700657-002

2008614-001

2010210-001

916 096 00

Ansicht ohne casing cover dargestellt

View shown without casing cover

923 081 00

Beschriftung inscription

927 229 00

927 229 02

3-4 CardioSoft FSM Revision C

2040396-086

Page 79

Acquisition Modules for CardioSoft: CAM-USB A/T & CAM-USB A/T KISS

3.2 CAM-USB A/T & CAM-USB A/T KISS

CAM-USB A/T is a 15-lead ecg acquisition device with USB interface and Analog-/Digital Trigger Outputs (A/T) . It consists of three main parts, the CAM-14 acquisition module, the CAM-USB A/T Interface box and an external medical power supply.

CAM-USB A/T KISS is a 15-lead ecg acquisition device with USB interface, Analog-/Digital Trigger Outputs (A/T) and an integrated suction pump. It consists of three main parts, the CAM-14 acquisition module, the CAM-USB A/T KISS Interface box and an external power supply.

Only additional lead wires and electrode grabbers are needed to complete the system

Hardware for the CAM-USB A/T or CAM-USB A/T KISS (see Figure 3-3).

Figure 3-3:

Supported PC and Operating Restrictions

The CAM-USB A/T or CAM-USB A/T KISS system are allowed to be connected to the USB port of any PC certified according IEC950.

The PC must not be within the patient care area in accordance with IEC 60601-1-1.

The CAM-USB system may only be connected directly to a PC's USB PORT. It is not allowed to use any USB-HUB or cable extension between PC and the CAMUSB A/T or CAM-USB A/T KISS system.

Due to electrical safety of patient, only the included wall-pluggable medical power supply is allowed to be used with the devices.

Supported Operating Systems and System performance

CAM-USB A/T (P/N: 2009500-001), CAM-USB A/T KISS (P/N:2009500-009) are working with CardioSoft V6.5 software or higher and with:

a) Windows XP Professional 32-bit (SP2 or SP3)

Recommended PC: 1.6 GHz min., 512 MB SDRAM min., 20 GB HDD min.

Revision C CardioSoft FSM 3-5

2040396-086

Page 80

Acquisition Modules for CardioSoft: CAM-USB A/T & CAM-USB A/T KISS

b) Windows Vista Home Premium 32-bit (SP1)

Windows Vista Business 32-bit (SP1)

Recommended PC (P4 class): 2 GHz min., 1 GB SDRAM, 20 GB HDD min.

CAM-14 Acquisition Module

(P/N: 901142 - 005, 901142 - 008)

Functions

15-lead acquisition module

Interface

Serial digital communication interface with 1 MHz clock

CAM-USB A/T Interface and CAM-USB A/T KISS Interface

(P/N: 2009500 - 001 and 2009500-009)

Functions

The CAM-USB A/T or CAM-USB A/T KISS Interface serves as protocol converter to connect the CAM-14 acquisition module to the USB port of an standard IEC60950 PC. The externally powered (by an IEC60601-1 power supply) device contains the USB cable as well as the CAM14 cable. Additionally four analog outputs and one digital output are supported by the device. The CAM-USB A/T KISS variant also includes a suction pump to supply the external KISS MULTILEAD electrode suction system. For the product safety there is a 1.5kV insulation between CPU core and CAM-14 acq. Module and an 1.5 kV insulation between CPU core and the Analog/Trigger outputs.

Interfaces

1. USB Interface: PC Communications Bus (12 MHz, full-speed device)

2. Power Input: 12VDC, max. 2A

3. CAM-14 Interface: Serial two wire protocol with 1 MHz serial clock.

4. Analog-/Trigger Outputs:

9-Pin Sub-D connector , Output pin-no. are identical to CASE. All output signals are short circuit protected.

1. +15VDC@50mAmax

2. CH1OUT, Analog Output; Range: -5V…+10V @RL>= 2kOhm

3. Digital Trigger Output with TTL-Level @ RL>=2kOhm

4. CH2OUT, Analog Output; Range: -5V…+10V @RL>= 2kOhm

5. GND

6. CH3OUT, Analog Output; Range: -5V…+10V @RL>= 2kOhm

7. NC

8. CH4OUT, Analog Output; Range: -5V…+10V @RL>= 2kOhm

9. NC

CH GND

(CH = connector housing)

3-6 CardioSoft FSM Revision C

2040396-086

Page 81

Acquisition Modules for CardioSoft: CAM-USB A/T & CAM-USB A/T KISS

5. Suction System Air Inlet (only in CAM-USB A/T KISS, P/N: 2009500-009)

Indicators

The CAM-USB A/T Interface and the CAM-USB A/T KISS Interface have two LED's (LED A, green and LED B, yellow) to display the actual interface status. Additional there is a buzzer to allow any acoustically signaling and the QRS beep (if enabled within the CardioSoft software).

Meaning of the system status LEDs

green LED yellow LED system status

ON OFF ECG signal transmission in pro-

gress

ON ON ready to send ECG signals

(e.g., no communication with

CAM-14)

OFF OFF no power

ON blinking communication with CAM-14 in-

terrupted

(e.g., CAM-14 not connected)

When a communication problem between the CAM-USB Interface Box and the PC occurs, the box will emit a continuous tone and both LEDs will be illuminated.

CAM-USB A/T Interface and CAM-USB A/T KISS Interface defects handling

According to the actual service strategy, there will be a possible exchange of the

1. Complete Box

2. PWA

3. Housing

4. USB-Cable

5. Cable to CAM-14

6. Power Supply

7. Suction Pump (2009500-009 only)

(see Spare Parts, chaper 8)

Reprogram the serial number after PWA or box exchange, see herefore chapter 4.5 Reprogramming of Serial Number.

Revision C CardioSoft FSM 3-7

2040396-086

Page 82

Acquisition Modules for CardioSoft: CAM-USB A/T & CAM-USB A/T KISS

3-8 CardioSoft FSM Revision C

2040396-086

Page 83

Acquisition Modules for CardioSoft: CAM-USB A/T & CAM-USB A/T KISS

Revision C CardioSoft FSM 3-9

2040396-086

Page 84

Acquisition Modules for CardioSoft: CORINA

3.3 CORINA

NOTE

The CORINA acquisition module is not for use in the U.S. and Canada.

3.3.1 Context

CORINA is an ECG recorder for CardioSoft. CORINA stands for CORD INTEGRATED AMPLIFIER and is an interface between patient and personal computer. There are four CORINA models.

3.3.2 Supported Operating Systems and System performance

CORINA and CardioSoft V6.x are working with

Windows XP Professional 32-bit (SP2 or SP3)

Recommended PC: min. 1.6 GHz, min. 512MB SDRAM, min. 20 GB HDD

3.3.3 Model 1 CORINA

Comprises the following components: Compact plastic casing with interfaces for patient cable and connection cable to PC. All the electronics are integrated inside the casing. This includes ECG preprocessor, controller to buffer data, data converter and transfer to PC. The electronics has its own power supply.

3.3.4 Model 2 CORINA with Suction Pump

Is designed for use with the Electrode Application System. The casing also houses the suction pump with the additional electronics required.

Casing design CORINA models 1 + 2:

Figure 3-4:

3-10 CardioSoft FSM Revision C

2040396-086

Page 85

Acquisition Modules for CardioSoft: CORINA

E C G

P r

c e s s i

n g

PC-PORT

CONTROLLER

Pump Module (optional)

o P

Lpl. CORINA

P a

e n t

a b l

3.3.5 Model 3 CORINA with Analog Output

As Model 1 plus additional analog ECG output. This output enables CORINA & CardioSoft models prior to release 3.0 output of lead II. The output signal of the analog output in the stress test mode is configurable.

3.3.6 Model 4 CORINA with suction pump and Analog Output

Like Model 3 with additional suction pump.

3.3.7 Replacement of CORINA Model 1...4 through newer CORINA Variants (101 118 31...34) with enhanced communication interface to PC

Note: Only CORINA Models 101 118 31...34 and 37/38 (OEM) are supported by CardioSoft V5.x or V6.x.

Note: Redesign of PCBs and PWAs due to EMC 2nd Edition:

- 101 118 31 ... 34: Starting with rev. G. New PWA and PC cable.

- 101 118 37, 38: Starting with rev. H. New PWA and PC cable.

CORINA Block Circuit Diagram

Block circuit diagram of CORINA models 1 + 2, in models 3 + 4 there is an additional functional block (= PCB CORINA TRIGGER) to generate the analog signal)

Figure 3-5:

Revision C CardioSoft FSM 3-11

2040396-086

Page 86

Acquisition Modules for CardioSoft: Introduction

3.4 Introduction

The “Hardware Design Description” describes the structure of the hardware implemented, internal interfaces and those for connection of peripherals.

3.4.1 Repair Procedure

A number is stored in the CORINA which allows the accurate assignment of user and software options.

Repairs conducted by:

– Availability of AT PCBs CORINA (6 types, 3 with and 3 without the possibility

This tool enables the authorized service technician to program the replaced CORINA PCB with the customer-specific serial number. The AT PCB is programmed. This number only allows the PCB to be modified by overwriting. Replacement works with the AT PCB only. The AT PCB can be programmed once only.

of plugging in the PCB CORINA TRIGGER). To reprogram the serial number please see chapter 4.5 Reprogramming Serial Number.

3-12 CardioSoft FSM Revision C

2040396-086

Page 87

Acquisition Modules for CardioSoft: Hardware Structure

3.5 Hardware Structure

3.5.1 Mechanical Structure

CORINA comprises 4 (optionally 8) mechanical functional units.

These are:

– casing

– floating screening

– PCB CORINA (5 types: a) 2x standard, b) 2x for Analog Out, c) standalone)

– cable to PC

– pump module for Electrode Application System (optional)

– PCB CORINA TRIGGER (optional)

– insulating foil for PCB Analog Out (optional)

– internal wiring Analog Out (optional)

3.5.1.1 Casing:

The casing comprises the following components.

– lower case shell

– upper case shell

– locking device

The pump module (optional) is affixed to the lower section of the casing. The PCB and the floating screening are attached to the upper section. The locking device is screwed to the PCB and serves to secure the Marquette HELLIGE patient cable.

Upper case shell with integrated PCB:

Figure 3-6:

Revision C CardioSoft FSM 3-13

2040396-086

Page 88

Acquisition Modules for CardioSoft: Hardware Structure

3.5.1.2 Floating screening:

Upper case shell with integrated PCB, incl. PCB CORINA TRIGGER:

Figure 3-7:

The floating screening comprises a plastic shell with a floating shield cemented in place. The plastic shell is secured with the locking device and by clipping it in onto the PCB. On the one hand, the floating screening protects the highly sensitive electronics from interference while on the other hand, the plastic shell ensures a defined safe gap to the metal plating of the casing.

Lower case shell with integrated pump module (old tubing system):

Figure 3-8:

3-14 CardioSoft FSM Revision C

2040396-086

Page 89

Acquisition Modules for CardioSoft: Hardware Structure

Lower case shell with integrated pump module (new tubing system):

Figure 3-9:

Figure 3-10:

Revision C CardioSoft FSM 3-15

2040396-086

Page 90

3.5.1.3 PCB CORINA

Acquisition Modules for CardioSoft: Hardware Structure

There are 4 PCB versions:

a) 2x Standard b) 2x for Analog Out

a) 2x Standard PCB:

The entire electronics as well as all interfaces are located on the PCB. The patient input socket is fixed permanently to the PCB. The lead to the PC and the power supply cable to the pump are plugged in. The operational readiness display (LED green) is also located on the PCB. When operative the light is transmitted to the outside of the casing via an optical fiber. The newer PCB version, used in CORINA 101 118 31...32 provides a newer communication protocoll to the PC and will not work inside other (older) CORINA variants.

b) 2x CORINA PCB model for CORINA TRIGGER (Analog Out)

It has longer male multipoint connectors than the standard PCB model. The PCB CORINA TRIGGER is plugged into this and the internal analog lead as well as, optionally, the suction pump connected.

The newer PCB version, used in CORINA 101 118 33, 34 and 101 118 37, 38 provides a newer communication protocoll to the PC and will not work inside other (older) CORINA variants.

Figure 3-11:

3-16 CardioSoft FSM Revision C

2040396-086

Page 91

3.5.1.4 Cable to PC

Acquisition Modules for CardioSoft: Hardware Structure

The connection cable to the PC has a 25-pin plug on the PC side. The plug casing also houses a 3-pin socket. A plug-in power supply, supplying CORINA with power, is then connected to this socket. On the CORINA side“ is a 26-pin or 20-pin (EMC redesign) socket terminal strip. This is then plugged directly onto the PCB.

Figure 3-12:

3.5.1.5 Pump Module

The pump module comprises the following components:

– pump

–PCB

– tubing connection

Pump (old tubing system)

Figure 3-13:

Revision C CardioSoft FSM 3-17

2040396-086

Page 92

Acquisition Modules for CardioSoft: Hardware Structure

Pump:

When using the PCB Analog Out the power line to the suction pump (optional) is not plugged into the PCB CORINA, but the PCB CORINA TRIGGER.

CAUTION: When used together with the PCB CORINA TRIGGER, the braided pumppower supply wires must be covered by a heat-shrinkable tube!

Pump (new tubing system)

Figure 3-14:

PCB:

The PCB is screwed onto the pump casing. The electronics for pressure regulation is located on the PCB. The 12-V power cable is soldered to the PCB.

Tubing connection:

The air tubing is preassembled and only needs connecting to the nozzle (on the casing).

3.5.1.6 PCB CORINA TRIGGER

There is a floating, analog ECG output based on an optional plug-in card. It provides a 1V/1mV signal (unedited signal, without filter and ADS, pacing pulse is blanked out)at the analog output. The PCB CORINA TRIGGER only needs plugging in. It remains firmly attached without requiring any additional fixation. The standard signal to be output is a lead II signal. For CORINA and CardioSoft Version 3.0 and later versions the output signal can be configured in the stress test mode.

Peripherals can be connected via a 3-pin output socket. Pin assignment of this socket: Pin 1 = Analog Out, Pin 2 = ground, Pin 3 = reserved (also refer to Section 3.4.2.3)

3.5.1.7 Insulation Foil for PCB CORINA TRIGGER

The insulation foil serves to effect floating isolation of the analog section of the PCB CORINA TRIGGER with reference to the casing and (optionally) to the pump.

3-18 CardioSoft FSM Revision C

2040396-086

Page 93

Acquisition Modules for CardioSoft: Hardware Structure

P a t

e n t

a b l

S i

g n a l I

p u t P r

o t

e c t

o n

o n t

r o

e r

O p

o c o u p

e r

D C

T r a n s f o r m e r

Clock

ASIC1

ASIC2

ASIC3

P r

e a m

p l

e r

o a t i

n g

p a t h

3.5.1.8 Internal Wiring of the Analog Output

The connection from the analog output of the PCB CORINA TRIGGER to the 3-pin output socket on the casing is effected using a lead covered by a heat-shrinkable tube. For EMV purposes there are two wide-band interference suppression coils inside this tube. Using this tube effects high-voltage-resistant isolation between the analog output signal and ground and patient floating part.

3.5.2 Electrical and electronic structure

The entire CORINA electronics is divided up into three functional units and located on a PCB. These are ECG CONDITIONING, CONTROLLER and PC PORT. (In addition, optionally, Analog Out electronics on the plug-in PCB CORINA TRIGGER).

3.5.2.1 ECG Processing

– acquisition and analog-digital conversion of the ECG signals via up to 11

electrodes

– preprocessing and intermediate storage of the data

– data transfer via a serial interface

– additional functions are: pace identification, checking and testing functions,

configuration of the inputs, N negative-feedback loop, measurement of d.c. voltage and blocking function

Transfer of data between the functional unit ECG Processor and CONTROLLER is via a QSPI interface. The exact specifications are described in the document [ASIC Interface].

Figure 3-15:

3.5.2.2 CONTROLLER

– all CORINA control functions

– initialization of hardware

– data communication from and to the functional unit ECG Processor

– data communication from and to the functional unit PC PORT

Revision C CardioSoft FSM 3-19

– output of ECG data to DA transductor on PCB CORINA TRIGGER (optional)

2040396-086

Page 94

Acquisition Modules for CardioSoft: Hardware Structure

68332

R A M

R O M

Reset

Control-B us

Data-Bus

Address-Bus

QSPI-Bus

Signal Generator

o P

O R T

o E

C G

P r

o c e s s i

n g

Pe riphe ryExpansion

Figure 3-16:

CORINA is controlled by the Controller 68332. This controller already has all the important functions required to control CORINA.

These are:

– CPU ( 68000 family plus 68020 commands plus commands for controller

applications )

– 2 serial interfaces ( SCI, QSPI )

– on-chip memory ( for faster applications )

– maximum of 12 programmable chip selects

– interrupt manager

– intelligent 16-bit timer

– clock generator

Memory:

A 128 kByte FLASH ( 128 K x 8 PEROM ), which can be programmed directly with the 5-V operating voltage supply, is used as a program memory store. This permits the subsequent loading of software updates using the PC. The data memory comprises the ON-The interrupt requests IEKG_and IPCPW_ are both stored by using FLIPFLOPS, since the interrupt inputs IRQ1 to IRQ6 are only level gated. In contrast to the others, IRQ7 is edge gated and can thus be actuated directly. Resets are generated by a MICROPROCESSOR SUPERVISORY CIRCUIT. A floating section is used to connect the functional unit ECG Processor to the QSPI interface of the 68332. This is a full duplex interface with data input MISO ( MasterIn Slave-Out ), data output MOSI ( Master-Out Slave-In ) and serial clock SCK. A maximum of 4 devices can be connected to this interface. To achieve this, the PCB is equipped with a connector onto which this bus can be switched in. Using this connector thus allows the connection of a maximum of 3 further peripherals (e.g., experimental input). One of the peripherals is the PCB CORINA TRIGGER (optional).

2040396-086

A signal transmitter gives an acoustic status message. This signal transmitter enables signalling of errors, for example.

3-20 CardioSoft FSM Revision C

Page 95

3.5.2.3 PC PORT

12V

FIFO

ESD

Control-Bus

Data-Bus

ESD

D r

v e r

5V Supply

o P

o C O N T

R O

L L E R

5V (direct)

N P U T

Acquisition Modules for CardioSoft: Hardware Structure

– CORINA power supply

– ESD protection

– data communication to and from PC

Figure 3-17:

All cables leading to and from the PC are provided with ESD protection. A DC/DC transducer is used to generate the 5 V. This transducer generates the 5-V power voltage from the 12 V received from the plug-in power supply. The DC/DC transducer can be switched on and off by the PC via the control cable. There is a connector on the PC to connect the 12 V. The pump module can then be connected to this connector. Data communication between PC and CORINA is via a FIFO. This enables the PC to pick up ECG data at any time. The FIFO has a memory depth of 8 K / 32K X 9 bits, 7/4 bits being used (of these, 6/3 bits for ECG data and 1 bit for synchronization).

All output leads are led through a driver chip.

3.5.2.4 Optional Analog Out Electronics

The PCB CORINA TRIGGER provides the user with a floating analog ECG output signal for connection to ultrasound units. Pacing pulses are blanked out.

Funtionality:

Using QSPI (serial data transfer) the ECG data are transmitted via a medically floating segment to a D/A transducer (10 bits) located on the PCB CORINA TRIGGER. The analog output signal is subsequently standardized, amplified and made available to the user. The signal is short-circuit-proof, unfiltered and does not have ADS bedside processing.

CAUTION: To enable QRS complex triggering when using PACE, the pacing pulses are removed from the ECG signal.

Revision C CardioSoft FSM 3-21

2040396-086

Page 96

Acquisition Modules for CardioSoft: Hardware Structure

non-

floating

Data via

QSPI

POWER

+12V

-12V

Reg.

DC/DC

Converter

Opto-

Couplers

DA-

Converter

Analog

Amplifiers

1uF

Figure 3-18:

CAUTION: When connecting up an ultrasound unit it is important to ensure that the instrument connected has an input LPF of < 400 Hz. If this is not the case, an external (passive) low pass should connected to the input of the peripheral.

Suitable low-pass configuration: Revision C

Figure 3-19:

3-22 CardioSoft FSM Revision C

2040396-086

Page 97

Acquisition Modules for CardioSoft: Hardware Structure

3.5.3 Internal Interfaces

3.5.3.1 Mechanical Interfaces

Tubing connection of the pump module:

3.5.3.2 Electrical Interfaces

Figure 3-20:

The pump module air tubing is preassembled and only needs connecting to the nozzle (on the casing).

CORINA has three internal interfaces. These are:

– interface to pump module

– debugging interface

– interface for further peripherals (PCB Analog Out):

Interface to pump module:

Description of interface:

Figure 3-21:

Revision C CardioSoft FSM 3-23

2040396-086

Page 98

Acquisition Modules for CardioSoft: Hardware Structure

The pump module interface is in the form of a 3-pin male multipoint connector. The pump module requires only a 12-V power supply.

3.5.4 Interfaces to Peripherals

3.5.4.1 Mechanical Interfaces

CORINA has three mechanical interfaces. These are:

– power cable to PC

– connection socket for patient cable

– nozzle for air tubing

– optional: Analog Out connector

3.5.4.2 Electrical Interfaces

3.5.4.2.1 Interface to PC:

Figure 3-22:

CORINA has two external interfaces. These are:

– interface to PC

–ECG input

– optional: Analog Out

Data interface:

Figure 3-23:

3-24 CardioSoft FSM Revision C

2040396-086

Page 99

Acquisition Modules for CardioSoft: Hardware Structure

Description of interface:

OUT(0-5) data to PC

OUT6/ACK data bit to PC and data acceptance confirmation this interface

lead fulfils two functions

READ MODE -> data line D6 (data from CORINA -> PC)

WRITE MODE -> ACK* (data from PC -> CORINA)

For outputs OUT(0), OUT(1) and OUT(3) it is important to observe that these are output inverted by CORINA since, initially, the PC inverts these inputs. In newer CORINA versions (101 118 31...38) a new cable to PC is used, where only OUT (2, 4, 5) are used to transmit data to the PC.

ERROR* indicates “full or empty FIFO”

IN(0-3) data from PC

ES selection whether ERROR* should indicate “full or empty

FIFO“

ES = LOW -> CORINA indicates “empt“ FIFO

ES = HIGH -> CORINA indicates “full“ FIFO

READ* transmit data to PC

WRITE* read data from PC

ON switch on CORINA

ON = LOW -> CORINA is switched off

ON = HIGH -> CORINA is switched on

3.5.4.2.2 ECG Input:

Power source interface:

Figure 3-24:

As of 05/1997 this interface no longer delivers a 5-V signal.

Figure 3-25:

Revision C CardioSoft FSM 3-25

2040396-086

Page 100

3.5.4.2.3 Analog Out

ECG

Ground

Acquisition Modules for CardioSoft: Hardware Structure

Description of interface:

E_R electrode input right arm E_L electrode input left arm E_F electrode input left foot E_N electrode input right foot E_C1 electrode input chest electrode C1 ( Wilson ) E_C2 electrode input chest electrode C2 ( Wilson ) E_C3 electrode input chest electrode C3 ( Wilson ) E_C4 electrode input chest electrode C4 ( Wilson ) E_C5 electrode input chest electrode C5 ( Wilson ) E_C6 electrode input chest electrode C6 ( Wilson ) E_NAX electrode input chest electrode NAX ( Nehb ) E_NST electrode input chest electrode NST ( Nehb ) E_S shielding

Figure 3-26:

Pin assignment of this socket: Pin 1 = Analog Out, Pin 2 = ground, Pin 3 = reserved.

3-26 CardioSoft FSM Revision C

2040396-086

General Electric CARDIOSOFT SERVICE MNL-VER6.6_SM_2040396-086_C Thermacare REF TC3003 Convective Warming System

Specifications and Main Features

Frequently Asked Questions

User Manual

1 Introduction

1.1 Manual Information

1.1.1 Revision History

1.1.2 Manual Purpose

1.1.3 Intended Audience

1.2 Safety Information

1.2.1 Responsibility of the Manufacturer

1.2.2 General

1.3 Warnings, Cautions, and Notes

1.4 Equipment Symbols

1.5 Service Information

1.5.1 Service Requirements

2 Installation

2.1 Installation of the Software

2.1.1 Installation of CardioSoft

2.1.2 Installation of Communication Server

2.1.3 General Entries in INI Files

2.1.4 Entries in LOC_WIN.INI

2.1.5 Entries in CARDIO.INI

2.1.6 Entries in SETUP_CM.INI

2.1.7 Entries in CardioSoft.INI

2.1.8 Entries in HL7.INI

2.1.9 Directory structure and notes on CardioSoft files

2.1.10 System Configuration/Service screen

2.1.11 Data transfer to/from MUSE

2.1.12 Metabolic Interface

2.1.13 Configuration of "Complete Patient Information"

2.2 Installation of the hardlock modules (Parallel/serial & USB type)

2.3 MARS PC Application Configuration

2.4 Configuring a CASE/CardioSoft System with the EMR Application

Before You Begin

2.4.1 Configuring a CASE/CardioSoft System with the EMR Application

2.4.2 Install the Centricity EMR Application

2.4.3 Migrate Historical CardioSoft Data

2.5 DICOM Interface Configuration

2.5.1 Terminology

2.5.2 General

2.5.3 Setup

2.5.4 Special DICOM setup items without UI

2.5.5 Protocol Code Mapping

2.5.6 Description of dialogs

3.1 CAM-USB

3.2 CAM-USB A/T & CAM-USB A/T KISS

3.3 CORINA

3.3.1 Context

3.3.2 Supported Operating Systems and System performance

3.3.3 Model 1 CORINA

3.3.4 Model 2 CORINA with Suction Pump

3.3.5 Model 3 CORINA with Analog Output

3.3.6 Model 4 CORINA with suction pump and Analog Output

3.3.7 Replacement of CORINA Model 1...4 through newer CORINA Variants (101 118 31...34) with enhanced communication interface to PC

3.4 Introduction

3.4.1 Repair Procedure

3.5 Hardware Structure

3.5.1 Mechanical Structure

3.5.2 Electrical and electronic structure

3.5.3 Internal Interfaces

3.5.4 Interfaces to Peripherals