Medilog Darwin Installation and Administration Guide Edition 16 2006

Installation and Administration Guide

~€~~Io~DARw HOLTER ANALYSIS

Instructions for Use

Installation and Administration Guide

The Medilog AR4, Medilog ART2 and Medilog BX recwdm have not been a p p v e d for sale in the USA by the FDA and therefore the use of these recorders with Medilog Darwin in the USA is not approved w supported.

The greatest care has been taken in compiling the text and diagrams for this manual. However, the possibility of errors cannot be ruled out. The publisher, authors and translator accept no legal responsibility or any other kind of liability for incorrect data and their consequences. All rights reserved, including photomechanical reproduction and storage via electronic media. The commercial use of the models and work shown in this manual is not permitted. @

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2004-2006 TOM Medical Entwicklungs GmbH 2005, 2006 Huntleigh Healthcare

Edition: Editor:

1 6 (refers t o Medilog Darwin version 1.6) TOM Medical Entwicklungs GmbH

Year of publication: 2006

cc 0088

The Medilog Darwin software meets the essential requirements of the Medical Device Directive 93/42 EEC (and the Austrian medical device law).

Manufactured by Huntleigh Healthcare 35 Portmanmoor Road, Cardiff CF24 5HN. United Kingdom www.medilogholter.com Medilog" is a registered trade mark of Huntleigh Healthcare. Windows 2000" and Windows X P are registered trademarks of Microsoft Corporation. Other brand names and product names are trademarks or registered trademarks of their respective holders. End-of-life disposal Definition: this symbol indicates that this product comes under the provisions of EU Directive 2002/96/EC on waste electrical and electronic equipment (WEEE)'and that this unit was placed on the market after 1 2 August 2005. This directive covers EOL (end-of-life) disposal. Rules for the User: within the EU, at end-of-life, this product may be disposed of only through a government approved collection scheme or treatment facility. If in doubt contact your local Medilog representative.

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Installation and Administration Guide

Content Packing List ... -6 Content of the CD ...6 Warnings ...7 Regulatory. Safety and Electromagnetic Compatibility Requirements...8 System Configuration ...ll Cleaning and Maintenance ...1 5 Planning the Software Installation ... 1 7 Software Installation Procedure ...19 Setting up the Software ...23 Backup and Restore...28 References. ...- 3 2 Contacts ... 3 3

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The Medilog AR4 Medilog AR12 and Medilog BX recorders have not been approved for sale in the USA by the FDA and therefwe the use of

these recorders with Medikg DMnh in the USA is not approved M suppated.

Packing List The Medilog Darwin software package contains the following items: Medilog Darwin lnstallation CD software protection key lnstallation and Administration Guide (this document) User Manual (Instructions for use) You can find any other document referred to in one of the documents listed above in electronic format (Adobe PDF) on the Medilog Darwin Installation CD. In order to read these documents you will need to have the Adobe Acrobat Reader installed on your computer. You can find a copy of this software on the CD in the folder: "SupplementAdobe"

Note

Warning

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The Medilog Darwin lnstallation CD and this guide should be kept separately from the installed software t o ensure that the administration password remains secure.

Content of the CD Folder Setup Docs Admin

Supplement Samples

Purpose Contains the complete set of installer applications for Medilog Darwin and its required associated programs. Contains further readings regarding the Medilog Darwin software and its components in electronic format (PDF) Contains documents needed for the system administrator. These documents should not be accessible to nonadministrative personnel. Additional, mainly third party software which complements the functionality of Medilog Damin This folder contains sample recordings which can be used with Medilog Darwin. Files "Autorun.exe", "Autorun.inP', and "Darwin.ico" are required for the installation software. To start the installation software manually, double-click the "Autorun.exe" file.

Installation and Administration Guide

Warnings US Federal Law restricts this device to sale by or on the order of a physician. Use the Medilog Darwin system under the direction o f a physician. Read and thoroughly understand the manual before use, particularly the sections on Intended Use and Indications for Use. The intended location for use is the cardiology department o f a hospital. It is required that all equipment attached to the patient be electrically isolated. The system must be powered from a suitable medically approved mains isolation transformer. A suitable isolation transformer can be purchased from Huntleigh Healthcare. This software must be installed on a Medilog Darwin computer system supplied by Huntleigh Healthcare, or on a computer system with an equivalent specification, including regulatory, safety and electromagnetic compatibility requirements as stated on page 11 of this manual. The operator must not touch parts of non-medical equipment in the patient environment, that, after removal of covers, connectors etc, without use of a tool, maybe contacted by the operator during maintenance, calibration etc. It is important for the user to archive all data, and for the hospital IT department t o back up all system files, on a regular basis. There should be established procedures for archiving and backup, and the hospital should make sure these procedures are followed. Use the Medilog Darwin software as stand-alone software. Do not run multiple software applications simultaneously under Windows 2000 or Windows XP Professional while running the Medilog Darwin software. Do not use the Medilog Darwin system in areas where flammable, explosive, or anesthetic agents are used. The system is not intended for use during anesthesia. Due to the shock hazard that can exist within the PC when the cover is removed, only qualified service personnel should perform service. Never use extension AC power cords with the PC computer; chassis leakage current may increase. Routinely inspect cableslleads assemblies for cracks, holes, tears, cuts, etc. that could present problems t o the system. This system may contain a lithium battery. There is a danger of explosion if it is incorrectly replaced. Batteries must be replaced by a Huntleigh Healthcare approved service person. Replace with the same type of battery or an equivalent recommended by the manufacturer. The Medilog AR4, Medilog AR12 and Medilog BX recorders have not been approved for sale in the USA by the FDA and therefore the use of these recorders in the USA is not approved or supported. The following functionality in Medilog Darwin is currently unavailable for use in the USA: o Atrial Analysis o Respiration o ECGD 12-lead Derived

The Medilag AR4. Medilog AR12 and Medilog EX record-

have not been approved for sale in the USA by the FDA and therefore the use of

these recorders with Medilog Darwin in the USA is not appmved M supported.

Warning

A

Caution

A

Regulatory, Safety and Electromagnetic Compatibility Requirements Regulatory Requirements For Europe, the computer system on which the Medilog Darwin software is installed must comply with Directive 73123lEEC (the "Low Voltage Directive") and Directive 891336lEEC or 20041108lEC (the "EMC Directive") and must carry the CE Marking to demonstrate this compliance. It must also comply with the appropriate standards listed below under "Safety Requirements" and "Electromagnetic Compatibility Requirements". For the USA, the computer system on which the Medilog Darwin software is installed must comply with the appropriate safety requirements o f the Occupational Safety & Health Act (OSHA) and be listed by a Nationally Recognised Test Laboratory (NRTL). It must also comply with the electromagnetic compatibility requirements of the Federal Communications Commission (FCC) in Title 47 of the Code of Federal Regulations (CFR). Additionally, medical systems incorporating PCs must comply with the following safety requirements: For Europe, the requirements of Directive 93142lEEC (the "Medical Device Directive") with CE Marking where applicable. For the USA, the Food and Drug Administration (FDA) requirements in Title 21 of the CFR. Overall, medical systems may thus require additional safety equipment and precautions as detailed in "Safety Requirements" and Electromagnetic Compatibility Requirements" below, and in "System Configuration" on Page 9 of this manual. For installation in other areas o f the world please seek further guidance from Huntleigh Healthcare about your local requirements.

Safety Requirements The computer system on which the Medilog Darwin software is installed must comply with the following safety standard: IEC 60950 Safety of Information Technology and Business Equipment (or a regional implementation of this standard, such as EN 60950 for Europe, or UL 60950 and its associated standards for the USA). Additionally, medical systems incorporating 'PCS must comply with the following safety standards: For Europe, the appropriate elements of the following: EN 60601-1 Medical electrical equipment. General requirements for safety.

Installation and Administration Guide

EN 60601-1-1:2000 Medical electrical equipment. General requirements for safety. Collateral standard. Safety requirements for medical electrical systems. EN 60601-1-4: 1996 + A1 :l 999 Medical electrical equipment. General requirements for safety. Collateral standard. General requirements for . programmable electrical medical systems. For the USA, the appropriate elements of the following: Article 517 of ANSl CIINFPA 70 National Electrical Code, NFPA 99: Standard for Health Care Facilities, and associated standards such as: ANSIIUL 544 Standard for Medical and Dental Equipment. ANSIIUL 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety. Compliance with these standards may require additional safety precautions, such as a medical-grade isolating transformer. When installing a medical system you further must observe the following: If non-medical equipment (eg the PC or printer) with enclosure leakage currents greater than those allowed by IEC601-1lEN60601-1 is to be used in the patient environment (within 1.5m of the patient), you must bring the enclosure leakage currents within the limits laid down by IEC6011lEN60601-1. This may be done by using a isolating transformer such as the one supplied by Huntleigh Healthcare. Anybody who connects additional equipment to signal input or signal output parts of the system is configuring a medical system, and is therefore responsible for ensuring that the system complies with IEC601-11lEN60601-1-1. If you are in any doubt whether your system does comply, consult the technical service department of your local Huntleigh Healthcare representative. The connection of extra equipment to the patient could lead t o an increase in leakage currents. The user must ensure that safe leakage currents are not exceeded.

Electromagnetic Compatibility Requirements The computer system on which the Medilog Darwin software is installed must comply with the following electromagnetic compatibility (EMC) standards: For EMC emissions: ClSPR 22 lnformation technology equipment. Radio disturbance characteristics. Limits and methods of measurement (or a regional implementation of this standard, such as EN 55022 for Europe, or 47 CFR Part 15 Sub-Chapter J for the USA). For EMC immunity: ClSPR 24 lnformation technology equipment. Immunity characteristics. Limits and methods of measurement (or a regional implementation of this standard, such as EN 55024 for Europe). Additionally, medical systems incorporating PCs must comply with the following EMC standard: IEC 60601 -1-2 Medical electrical equipment. General requirements for safety. Collateral standard. Electromagnetic compatibility. Requirements and

The Medilog AR4. Medilog AR12 and Medilog BX recorders have not been appmved far sale in the USA by the FDA and therefore the use of

these recorderswith Medilq h w i n in the USA is not appmved or supponed.

tests (or a regional implementation of this standard, such as EN 60601-1-2 for Europe). Make sure the environment in which the Medilog Darwin system is installed is not subject to strong sources of electromagnetic interference (e.g. radio transmitters, mobile phones). This equipment generates and uses radio frequency energy. If not installed and used properly, in strict accordance with the manufacturer's instructions, it may cause or be subject to interference. Whether the equipment causes interference may be determined by turning the equipment off and on. If it does cause or is affected by interference, one or more of the following measures may correct the interference: Reorienting the equipment Relocating the equipment with respect to the source of interference Moving the equipment away from the device with which it is interfering Plugging the equipment into a different outlet so that the devices are on different branch circuits Adding accessories or components to a system, or modifying a medical device or system, may degrade the immunity performance. Consult qualified personnel ' before making changes to the system configuration.

Symbols used on Medilog Darwin Systems

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This symbol means: Refer to warnings in this manual This symbol means: Date of manufacture These symbols indicate conformity with the Medical Device Directive (93142lEEC)

0088

Use of the software Medilog Darwin analysis software is designed for use under clinical supervision. It should be operated, and the results interpreted, by persons trained in professional healthcare. It is not designed for use in critical-care applications. Institutions using Medilog Darwin should ensure that the equipment is used: only in the testing of suitable patients only by suitably qualified individuals

Installation and Administration Guide

System Configuration Protective earthing or an isolating transformer must be used in order t o meet the safety requirements of IEC 601-1-IIEN 60601-1-1 if the computer system is located within the environment of patients (1.5 metres).

Minimum Recommended System Requirements lntel Pentium 4 with 2 GHz or similar 20 GB hard disk (60GB recommended) 256 MB RAM (512 MB recommended) Microsoft Windows 2000 Professional (Service Pack 3) or MS Windows XP Professional Screen resolution o 1024 X 768 (minimum) o 1600 X 1200 (recommended) 2 X USB for the software protection key and the Medilog FD5 Compact Flash reader for Medilog AR4 and Medilog ARI 2 Serial interface for the Medilog BX PCMCIA reader for MedilogFD4 DVD + RW drive for backup TCPIIP compliant networking hardware Make sure that all components are installed properly before you start installing the Medilog Darwin software. The windows device manager must not show any exclamation or question mark in the list of installed hardware. When installing a required component, please refer to the installation guide that comes with this component. Make sure the component is listed in the section "Supported Devices" later on in this document.

The Medilag AR4. Medilog AR12 and Medilog EX recMdm have not been sppmved for sale in the USA by the FDA and therefwe the use of these RCWdWs with Medilog Darwin in the USA is not appmved or supponed.

Warning

Supported Recorders A t the date of printing the following recorders are supported by Medilog Darwin: Figure 1: List of supported recorders High resolution, 3-channel Holter ECG recorder for clinical applications. Infrared port for real time signal obsewation. Stores raw ECG data on a removable CompactFlash memory card.

MedilogAR4

MedilogARl 2

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MedilogFD5

m T =a3 MedilogFDl2

High resolution. 3-channel ECG recorder for scientific applications. Like the Medilog AR4 provides an infrared port and removable CornpactFlash memory card. Real time analysis and signal conditioning for EDR respiration detection, P wave detection and ECGD 1 2 lead derived ECG 3-channel Holter ECG recorder for clinical applications Display for signal observation Raw ECG data is downloaded to a replay system over a USB connection.

12-channel Holter ECG recorder for clinical applications Display for signal observation Raw ECG data is stored onto a removable CompactFlash card

Ambulatory Blood Pressure Recorder Configuration and data download over a serial connection.

MedilogBX Medilog Darwin is compatible with the Medilog FD4- Holter recorder. ECG is stored on a PCMClA card.

Warning

Please note that not every recorder listed here is available in all regions of the world. Hence, not all functions described in the Medilog Darwin User Manual will be accessible.

Installation and Administration Guide

Hardware Installation: Tower To install the Medilog Darwin tower: Make sure the PC tower and the printer are switched off, and disconnected from the isolation transformer and the main power supply. Position the isolation transformer, the PC tower and the printer on a table or trolley, as shown in the diagram. Connect the PC tower and the printer t o the isolation transformer. Use the printer cable to connect the printer to the appropriate connector on the PC (this could be either USB or LPTI depending on printer). Use the monitor cable to connect the monitor to the display connector on the PC. m Connect the isolation transformer to the main power supply.

O PC monitor C4 PC keyboard O Tower PC C9 Keyboard tray O Isolation transformer C 3 Printer Trolley not included!

Power requirements 100-120V or 220-240V (& 10%), 50-60Hz Check voltage settings on your system before powering on the first time

The Medilcg AR4, Medilog ART2 and Medilog EX recurden have not been approved for sale in the USA by the FDA and therefore the use of these recwders with Medlkg Dab in the USA is not appmved w supported.

Tower PC connections To connect the monitor, keyboard and mouse t o the tower PC, see the instructions supplied with the tower PC. To connect the printer t o the tower, see the instructions supplied with the tower PC and the instructions supplied with the printer.

Supported Devices For the latest list of supported devices visit "www.medilogholter.com".

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Third Party Software We advise users of this equipment t o be careful about installing supplementary applications programs on this system. Avoid programs which require changes to the system configuration, or which terminate and stay resident in memory. We do not warrant that its software is compatible with software from other suppliers, and accepts no liability for the consequences of any such incompatibility. In the Windows environment it is possible t o have more than one application running at a time. If you run your Holter system with other applications, the response of some features will deteriorate. To enjoy best performance from your Medilog system, make sure it is the only application open.

Viruses: Prevention and Treatment The best form of protection against software viruses is prevention. If other software packages must be installed, make sure they are new licensed copies from a reputable software house. Avoid the use of disks of unknown origin. We make every effort to ensure that this software and any subsequent software upgrade is free from viruses, and accept no liability for the consequences of a virus introduced into the system by a third party. If a system suddenly starts behaving in an inexplicable manner, it should be quarantined immediately, along with any other machines with which it normally shares data. The system(s) should be checked by a qualified service person to determine if a virus is present, or whether the strange behaviour was caused by something else, such as hardware failure.

Installation and Administration Guide

Cleaning and Maintenance Always switch off Medilog Darwin, and disconnect the AC supply cable, before attempting to carry out any cleaning or maintenance.

Warning

Cleaning Wipe the outside of the tower, with a cloth dampened in soap or detergent solution. Wipe dry with a clean cloth. Do not use isopropyl alcohol to clean the Medilog Darwin tower or notebook. Do not expose metal components (e.g. snap connectors) t o chemicals.

User maintenance These checks can be performed by any user of the equipment. Every three months: Inspect the AC supply cable, and all other cables and connectors, for loose or broken parts, or any other damage. Pay particular attention to the AC supply socket. Replace any broken or damaged transducers or cables.

Calibration The Medilog Darwin software does not require calibration.

Technical maintenance The checks below should be performed in the hospital by a qualified maintenance engineer. Every six months: Remove the fuse module using a small screwdriver. Raise the small latch and remove the fuse board for access to the fuses. Check the AC supply fuses are of the correct value: o 1A for > 200V systems o 2A for < 200V systems

Corrective maintenance All corrective maintenance must be performed by qualified engineers approved by Huntleigh Healthcare.

Servicing Servicing should be performed only by Huntleigh Healthcare or their appointed service agent. If you have difficulty obtaining service for Medilog Darwin, contact Huntleigh Healthcare (E-mail: [email protected]).

The Medilog AR4, Medilog A812 and Medilog BX recwden have not been appmved for sale in the USA by the FDA and therefwe the use of these recorderswith Medllog Damin in the USA is not appmved M supported.

Caution

Environmental conditions Recommended operating, storage and transport conditions +lO°C to +35"C Operating temperature Storageltransport temperature -20°C to +50°C Operating pressure 68 to 106 kPa (680 to 1060 mB) Storageltransport pressure 68 t o 106 kPa (680 to 1060 mB) Operating humidity 10% to 75% RH, non-condensing Storageltransport humidity 10% to 90% RH, non-condensing

Batteries The computer running the Medilog Darwin software may contain a lithium battery. There is a danger of explosion if it is incorrectly replaced. Batteries must be replaced by a Huntleigh Healthcare approved service person. Replace with the same type of battery or an equivalent recommended by the manufacturer.

Disposal of batteries Batteries must be disposed o f in accordance with local regulations. Follow the battery manufacturer's instructions. Do not attempt to recharge, open, heat, or dispose of in fire. Keep all batteries away from children. Disposal of equipment when it comes to the end of operating life, it should be disposed of in accordance with local waste regulations. Advice on this can usually be obtained from the local waste authority which is typically within local government offices.

Cleaning the CD and the software protection key Remove dust using a dry, soft and fluffless cloth. Do not clean the CD and the dongle using a solvent or cleanser. For cleaning the Palmn Handheld please refer to the handbook from the manufacturer. Storing the CD and the software protection key Avoid exposure t o temperatures beyond specified limits. Further avoid storage in humid or dusty environments and vibrations. Do not expose CD or dongle direct sunlight or other UVAlUVB radiation. min max unit "C Environmental temperature 5 65 Humidity (non-condensing) 0 95 %RH

Disposal of CD and software protection key Please follow the local guidelines and regulations regarding the disposal of the CD and the software protection key.

Installation and Administration Guide

Planning the Software Installation Models Medilog Darwin is available as three different models. The functionality is summarized in Figure 2. Figure 2: Models overview

Medilog Darwin

Viewing and database access J

Medilog Darwin Lite

J

Medilog Darwin ScanLab

J

Medilog Darwin HRV

J

Medilog Darwin Atrial

J

Medilog Darwin Apnea

J

Editing and automated beat analysis J

Recorder support: set-up and upload J

The models Medilog Darwin ScanLab, HRV, Atrial, and Apnea have a limited functionality compared to Medilog Darwin. You can find further information in the "Instruction for Use" The software is protected by a software protection key. In order to use the software a key must be connected to the computer's USB port. Medilog Darwin consists of two separate applications: the Medilog Darwin main application, and the Firebird" database server Medilog Darwin may be installed on one standalone computer. The main application accesses the local database directly. Figure 3: Standard Installation

The Medilog AR4, Medilag All12 and Medilog BX recorders have not been appmved for sak in the USA by the FDA and therefore the use of

these recwders with Medilog Damin in the USA is not appmved or supported.

Note

Further Preparations Unless you plan to install Medilog Darwin on a closed system only you have to plan the locations where data is stored in a network. For personal data protection reasons Medilog Darwin stores the raw ECG and annotations, and the related patient demographic data at two different locations: Anonymous raw data and its annotations are simply stored in a folder. This folder must be shared folder and accessible on every computer in 'the network where a Medilog Darwin client is going to be installed. The patient demographic information is stored scrambled in a database file maintained by the Firebird' database server. A Firebird' database consists of a single file with the extension ".GDBW. This file needs t o be directly accessible by the Firebird' database server and must therefore be located on the same computer on which the database server is running.

Note

Later on during the installation process you are asked to specify the location of the database and the raw data folder. Especially when assigning the raw data path, make sure you choose a location which provides enough space for the large amount of ECG data. Figure 4: Distribution of data

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Fz-3Recording 1 j I

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ti23Recording 2

Installation and Administration Guide

Software Installation Proced~~re Installing from the Medilog Darwin Installation CD Install any components used with this software first and make sure the system is stable and all hardware conflicts are resolved before you commence installing the Medilog Darwin software. 1.) Remove all software protection keys from the computer.

2.) Power up the computer you want to install the software. 3.) Log in as "Administrator". You must possess administrative rights on the computer in order t o install Medilog Darwin properly.

4.) Insert the Medilog Darwin Installation CD into the CD drive of the computer. After a few seconds an animated set-up window should appear automatically. If this set-up window does not appear and your CD drive does not access the disk at all, please make sure that the "AutoPlay" property o f your CD drive is enabled. Figure 5: Installations screen: Language selection

Choose your preferred language for the installation process, here.

The Medilog AR4. Medlhy AR12 and Medilog BX recorders have not been approved for sab in the USA by the FDA and therefare the use of

Uwse recorders with Medihy Darwin in the USA is not approved or supponed.

Note Fa

Note

Medilog Darwin always installs all language packages that are supported. You can change the user interface using the AdminTool after installation.

5.) Start Installation

On this screen you have the following choices: Install Starts the installation of the Medilog Darwin software package with the selected +Options. Options This button leads to a separate screen, where you can add several software packages to the installation. View Documentation A list o f related documents available on the CD will be displayed, when you click this item.

Hint

To start the installation, click "Install" and thoroughly follow the instructions of the installation windows. After the installation is finished the "AdminTool" is started automatically to adjust the software to your hardware. Please refer t o chapter "System Administration" later in this manual for more details. Make sure the USB Software Protection Key is not connected to your computer system before installation. Plug in the USB Software Protection Key after the installation is complete or during installation, when you are requested to by the installing software.

Installation and Administration Guide