MediaStroboscope Operating Instructions June 2004

English

1.0 Introduction 1.1

Notes on operating instructions

z These operating instructions contain important notes on how to operate the MediaStroboscope safely, correctly and effectively. Therefore, they are intended not only for new operating personnel to be instructed in its use, but also for use as a reference manual. They help to avoid risks, and also to reduce repair costs and down-time. Furthermore, reliability and service-life of the equipment will be increased. For these reasons these operating instructions must always be kept available near the appliance. Prior to first use please peruse the chapter “For your safety”, in order to be prepared for any possible dangerous situations. The basic principles are: Judicious and careful work provides best protection against accidents! Operational safety and readiness for use depend not only on your capabilities, but also on care and maintenance given to the MediaStroboscope. For this reason regular cleaning and service work are a must. Major maintenance and repair work may be carried out only by expert personnel authorised by ATMOS. In case of repairs you should insist that original spare parts only are used. You will then have the warranty that operational safety, readiness for work and the value of your appliance will be preserved.

z The product MediaStroboscope bears CE Marking CE0124 according to the EEC guideline of the council for medical products 93/42/EEC and meets the basic requirements of this guideline.

z The quality management system applied at ATMOS has been certified according to international standards EN ISO 9001 and EN 46001.

z Reprints, also in extracts, only with written permission by ATMOS. Abbreviations / symbols in these operating instructions:

z Indicating a list • Subdivision of a list/activity. The recommended sequence must be followed in each case!

 Indicating particularly important advice!

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English 1.2

Function

z The basic system configuration features the following options: • clearly structured intuitive operating guide; • database reduced to essential information; • integrated high-resolution CCD colour camera incl. microphone connection; • video and audio output; • recording, archiving and playback of video, audio and additional data; • export of video and audio information to specific evaluation programmes; • export of pictures to standard programmes e.g. word processing; • control of all system components.

1.3

Scope of delivery

z Medical PC (corresponds to Directive 93/42/EEC for medical products), consisting of: • housing with power unit and motherboard; • system hard disk and video hard disk; • AV master board and graphics board; • Strobo interface; • 3,5” floppy drive, CDR drive; • archiving drive for removable storage media; • camera module, built-in; • operating system; • application software MediaStrobo; • application software WinSAL (demo version); including also: • keyboard and mouse; • monitor with audio reproduction system; • ½” CCD pin camera with 3 m connecting cable and C-mount adapter; • microphone with 3 m connecting cable; • MS box foot-operated regulator and connecting cable ; • all other necessary connecting cables; • removable storage medium (JAZ); • manuals for system components; • software on various data carriers.

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English 1.4

Explanation of symbols

Pay attention to operating instructions!

Data input

Shutter on Shutter off (=automatic intensity control)

Data input / output (dialog)

White balance, freewheeling

Protective earth (ground)

White balance, fixed

Foot control

Overall picture as evaluation window for white balance

Monitor connection

Display detail as evaluation window for white balance

Mouse connection

Overall picture as evaluation window for automatic intensity control Display detail as evaluation window for automatic intensity control

Keyboard connection

Printer connection

Serial interface 1

2

Serial interface 2

USB connection

Connection for microphone

Connection for camera head 9

English

2.0 For your safety z The MediaStroboscope is designed in accordance with

IEC 601 / EN 60601. The unit conforms to VDE protection class I and class IIa of the Medical Products Regulation (MPG). PC and monitor must each be connected to a separate properly installed socket outlet with earthing contact.

z Prior to putting the unit into service, make sure that the

voltage rating of the unit (see type label) corresponds to the voltage of your local mains supply. The power cords supplied with the unit (or equivalent power cords with country-specific plug) must be used exclusively for connection to the mains supply.

z The unit may only be operated under constant supervision

(IEC 601-1/EN 60601-1). The operator must be familiar with the operation of the unit.

z All connections must be checked for damages prior to putting the unit into service. Damaged cables must be replaced immediately.

z For the purpose of separating the unit from the mains,

the mains plug must always be pulled out of the socket first before unplugging the power cord from the unit. Never touch the power cord or plug with wet hands.

z The environmental conditions described in the technical specifications (section 11.0) must be observed.

z The unit must be protected from exposure to direct sunlight and must be kept away from heat sources.

z Always set up the unit in such a way that the operating panel is in clear view and within easy reach of the operator.

z The MediaStroboscope is not intended for operation in

areas of medical rooms subject to danger of explosion. Areas subject to explosion hazards may be created by the use of flammable anesthetics, skin cleansers and disinfectants.

z Ventilation of the unit must not be impeded by its position location. Take care that no liquid can get into the ventilation openings of the unit.

z In addition to these operating instructions, pay attention

to all further operating instructions for components which are part of the system.

z ATMOS may not be held liable for damages to persons or

property, if: - original ATMOS parts have not been used, or - the instructions for use contained in this manual are not observed.

z Data security: Please assure security of patient data when connecting the MediaStroboscope with any networks!

z The validity for the certificate of conformity expires if the customer himself or a third party manipulates the appliance, e.g. with modifications of any kind, by installing non-authorized accessories, removing danger and information signs as well as in case of inappropriate applications.

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English

3.0 Intended use z The MediaStroboscope is a computer-based video endoscopy worksite featuring specific enhancements for endoscopic laryngoscopy.

z The MediaStroboscope is used by properly trained medical personnel in hospitals and practices.

z In combination with the Endo-Stroboscope L and an optical system contained in the list of accessories, the Media-Stroboscope serves to record picture and sound signals which are received during laryngoscopy. The charac-teristics of the sound signal are being determined and recorded during this process and are available for ongoing evaluation, together with the picture data. Administration of data records is effected in a database which contains patient data, session data and data.

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English

4.0 Installation and start-up 4.1

Figure

Please note: PC work table, Endo-Stroboscope with accessories and printer are not included in the standard delivery of the MediaStroboscope!

x x

Fig. 1. Example of a MediaStroboscope work station 1.1 MediaStroboscope 1.2 Endo-Stroboscope L 1.3 Foot controller for Endo-Stroboscope L 1.4 Foot switch für MediaStroboscope

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English 4.2 

Installation Prior to first putting the system into operation, check whether the single components (plug-in cards, data cable,...) are correctly fixed.

z Because of the high weight of the single components, select a sufficiently stable location for the MediaStroboscope.

z The system components should be placed on the optional PC work-table. It provides for optimal positioning, secure stand and flexibility in operation.

z When selecting the position location, be sure to consider lighting conditions to avoid reflections in the monitor. Avoid direct solar radiation or positioning near heat sources.

2.1

2.2

2.3

4.3

Connecting the system components

z Connect the MediaStroboscope in compliance with the following descriptions.

z For the power supply of PC and monitor a separate earthing contact socket is to be used for each. The use of mobile multiway socket outlets is not permissible in this case! Connect the green/yellow line to the monotor and to the screws on the rear of the PC marked with the symbol

Fig. 2. 2.1 On/Off switch 2.2 Voltage adjustment 2.3 Power input

.

z Please pay attention that the voltage set at the power input of the PC is the same as the mains supply voltage. If necessary, the setting must be changed, using a screw driver [2.2]!

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English 4.3 3.2 3.3 3.1

Connecting the system components (contin.)

z Fix the short connecting cables as shown in fig. 3.

3.4

Fig. 3. 3.1 Connecting cable, green 3.2 Loudspeaker (audio out) 3.3 Connecting cable, red 3.4 Connecting cable, blue



To fulfill the safety requirements acc. to EN 60 6011-1/IEC 601-1-1, the following points must be taken into account:

z Telephone, Internet and network connections must be separated galvanically.

4.4

z Further components which are not separated galvanically, must be connected to the PC via an additional grounding conductor (in respect of the printer, the printer connection line is sufficient).

4.1

z The monitor is connected to the 15-pole socket of the graphics board [4.1], marked with the open symbol

4.2

.

The combination plug [4.3] is connected to V-in [4.2] and the COM interface [4.4].

4.3 Fig. 4. 4.1 Monitor connection 4.2 V-in 4.3 Combination plug 4.4 Com (serial interface) 19

English 4.3 5.1

5.5

5.2

5.2

5.3

Connecting the system components (contin.)

z Mouse to socket [5.5]

z Keyboard to socket [5.1]

5.6 z Optional printer to sockets [5.6] or [5.4]

 5.4

Installing additional peripheral devices and other system components may lead to a function failure of the MediaStroboscope. Prior to such an installation, contact an ATMOS service technician.

Fig. 5. 5.1 Connection for keyboard 5.2 USB connection for Strobo interface 5.3 Serial interface COM 5.4 Further USB connections (e. g. for printer) 5.5 Connection for mouse 5.6 Connection for printer (parallel interface)

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English 4.3.1

Connecting the MS-Box

z Make following connections: • Fixed cable [7.1] to multifunction connection on the

Fig. 6a.

EndoStroboscope L.

• Loose USB connecting cable [7.3] to input symbol (fig. 6a). • Foot switch (fig. 6b) for Start/Stop Video is fixed.

Fig. 6b.

• Connection [6.5] GG remains open.

7.3 7.1 7.2

7.5

76.4

Fig. 7.

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English 4.4

Software-Installation

z In delivery condition, your system is completely installed, i.e. the operating system of the computer, as well as the application software

MediaStroboscope

MS are ready for operation. In case of updates or additional software, please pay attention to the instructions for installation received with the delivery. Never try to install any programmes or updates on the video hard disk designated D: as, otherwise, destruction of the patient data base.

z Only install software which is supplied or expressly recommended by ATMOS. Installations are only to be effected on hard disk designated C:, otherwise the guarantee will become void.

z Only consider a new installation of the Media-Stroboscope software when you are absolutely certain that the application software does not function properly any longer. With a new installation, all the user information will become lost. In case of a new installation, proceed as follows: • Save complete contents of target drive C:, but predominantly the patient and result data bases MWSDB and MWSPIC, on a suitable data medium. • New installation of MediaStroboscope software by inserting the CD into your CD drive. • The installation programme starts automatically; please press the ?-key, read the advice and select the desired language version. • Then, follow the instructions of the installation programme.

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English

5.0 Operation 5.1

User guide and help

z The programme will guide you through the individual levels with the help of a clearly structured user surface.

z For navigation and activation of individual operating

elements, refer to the general WindowsTM guidelines. Please note that all operations with the mouse are completed only when the key is released.

z In each programme level you will be given detailed explanations by activating button (F 1) or key "Help" ( n , fig. 8).

z By means of key "End" (o, fig. 8) you can attain from any programme level the previous level. Use this key until you reach the desired level.

5.2

Starting work

z Switch on all components of the system, one after the other, the PC being the last one in the sequence.

z When the operating system has been booted, start the programme by clicking on the symbol

MediaStroboscope

MS If this symbol does not appear, there is the possibility to select and start the programme in the "Start menu" in "Programmes".

z Follow the work steps described in chapter 6: • in order to record a video, chapters 6.1 to 6.3; • in order to play a stored video, chapters 6.1, 6.2 and 6.4; • in order to view or change parameters and user data, •

chapter 6.5; in order to alter camera settings, chapter 6.6.

z If the system is to be operated by several users with different access rights, it is advisable to register them in the system as described in chapter 6.5.2.

5.3

Terminating work

z Leave the programme by (multiple) clicking of the key

"End" (o, fig. 8) and final confirmation of this command.

z Terminate Windows, i.e. activate the "Start" key in the Windows starting bar and select key "End".

z Switch off the individual components of the system in sequence after having received the success message that the PC can now be turned off.

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English

6.0 The functions The texts of the individual menus in the MS software as well as the online help are available in several language versions. The captions of the illustrations in this chapter are in English language. All icons and selection fields are therefore referenced with numbers, enabling you to find the position of the icons in each language. The headlines of the chapters always refer to the lettering in the right top button of the individual menu. The data base corresponds to a tree structure in which the sessions are allocated to the individual patients resp. the individual videos to the sessions (see fig. 9).

6.1

Login

z After starting the programme, the LOGIN menu appears. Here, the version number of your MS Software is faded-in briefly.

z Enter your user name in field n and your password in

field o. When starting the programme for the first time, enter the user name SUPERVISOR. For passwords and user names, see chapter 6.5.

6.2

Start

z Confirm with icon p to either enter a new patient or to create a new session for a patient already existing (continue with chapter 6.3).

z Use icon q to attain the archive. In this archive, you can

play and process stored video clips of different patients and sessions or enter results and comments (chapter 6.4).

z Use icon r to attain the adjustment of system parameters (chapter 6.5).

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English 6.3

New Patient

z To create a new patient, press icon t , enter the necessary patient data and confirm by using icon "Accept". Please note that the patient ID must be absolutely entered and that this entry must be unique.

z Use icon u to alternatively import patient data from the optional chip card terminal.

z Use icon s to select the relevant patient from the list; you will then attain the menu “Recorder” (continue with chapter 6.3.1).

z For navigating in the name list, use the function symbols and sort helps in the lower menu bar w.

z Use icon v to change the data of the patient selected.

6.3.1 Recorder mode z The bar on the right side 11 supplies information on the current values of frequency and sound pressure level as well as the mean value for frequency, pitch and sound pressure level in dB and volume classes.

z Recorder control is effected by the navigation keys 12 in the symbol bar at the lower image edge. Use icon to attain the menu for selecting one of the three available user profiles or the white balance for the camera. Prior to recording, effect a white balance (chapter 6.6.1).

z Use icon

to start recording (may alternatively also be done with "Enter" on the keyboard or by the foot switch); using icon will stop the recording process.

z Use icon

to freeze a single picture. In the subsequently offered menu, this picture can either be processed or copied in the Windows buffer for further processing in other Windows programmes.

z Use icon

to play the record again before it is saved with icon (alternatively as mentioned above). The recorder is then again ready for further recordings.

z The use of icon

refuses the recording without saving and enables a new one.

z Use icon

to enter or change results and diagnoses. Additionally, there is the possibility to shorten the video clip (chapter 6.3.2).

z To start recordings for another patient, quit the recorder mode using the icon "End". You will then attain the start level (chapter 6.2).

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English 6.3.2 Cut a video z Set mark in ( 13 ) and mark out ( 14 ) during the play mode of the video. This process can be repeated for several cuts. You can then get an overview of the selected sections by using the icon "Preview". The clips may then either be deleted again or stored.

 Always set mark in and mark out.  The last mark out must be prior to the last picture (= at least prior to the penultimate picture).

z The function keys for navigating are described in chapter 6.4.3.

 Upon storage, the original video will be overwritten.

6.3.3 Automatic archiving z If, during recording, the message "Disk full" appears, there is only limited storage space remaining on the video hard disk requesting an archiving of the data immediately or afterwards. Follow the respective instructions if you decide for immediate archiving.

z The bars appearing on the screen indicate the progress of archiving.

 Archiving is no backup (security file). Video is written on DVD/JAZ and deleted from the hard disk.

 Archiving cannot be started manually!

6.4

Archive

z Use icon 15 to select the relevant patient from the list; you will then attain the session menu (continue with chapter 6.4.1). For navigating in the name list use the function symbols and sort helps in the lower menu bar 19 .

z Use icon 16 to copy the patient data in the Windows buffer for further processing with other Windows programmes.

z With icon 17 patient data can be deleted, on condition that there are no more session data for this patient.

z Use icon 18 to change patient data.

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English 6.4.1 Session z Use icon 20 to select the relevant session from the list; you will then attain the data menu (continue with chapter 6.4.2). For navigating in the session list use the function symbols in the lower menu bar 24 .

z With icon 22 session data can be deleted, on condition that there are no more video data in the selected session.

z Use icon 23 to enter or change session data (comments).

z Icon 21 is not available at the moment.

6.4.2 Data z Use icon 25 to select the relevant data record from the list; you will then attain the "Player" menu (continue with chapter 6.4.3). For navigating in the data record list, use the function symbols in the lower menu bar 29 . Data records marked with are archived.

z Use icon 26 to export data in the optional additional programme Win SAL.

z Video data can be deleted with icon 27 . z Use icon 28 to enter or change results and diagnoses. Additionally, there is the possibility to cut video data (chapter 6.3.2).

z Archived video clips marked with

can no longer be

shortened.

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English 6.4.3 Player z Player control is effected by the navigating keys in the symbol bar 30 at the lower screen edge. This bar contains , pause , single picture forward , icons for play single picture reverse , fast forward and fast reverse . or the clip will be By longer pressing of the icons forwarded or rewound in slow motion. When permanently pressing the buttons or the video clip will completely be rewound or forwarded.

z When playing the video clip, the bar 32 on the right side supplies recorded information, current values of frequency and sound pressure level as well as the mean value for frequency, pitch and sound pressure level in dB and volume classes.

6.4.4 Picture ( 31 , fig. 19) z In addition, there is the possibility to print the picture directly with

.

 Prior to printing adjust the printer with

.

 As printer connection, only LPT1 is supported (parallel interface). USB connection is not possible!

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English 6.5

System

z Icon 33 will lead you to the adjustment of the I/O port for the interface card. Address 270 is the standard I/O address; a change will cause malfunction. When pressing key "Test" a firmware number will be displayed confirming that the Strobointerface board responds correctly.

z Icon 34 will lead you to the adjustment for time and class parameters for evaluating audio signals. Only change these adjustments if you are fully aware of the consequences. For further information, select the online help by pressing the ?-key.

z Icon 35 will lead you to the adjustment of the camera parameters (chapter 6.6).

z Icon 36 will lead you to the AV Master adjustments (chapter 6.5.1).

z Use icon 37 to attain the menu for entering users and passwords; access rights may here also be determined (chapter 6.5.2).

6.5.1 AV-Master z Only change the displayed adjustments for the AV-Master bord if you are fully aware of the consequences! Standard adjustments are: Video format: not marked, compression approx. 1:6, i.e. max. 100 MB/min. of data will arise. Video source: standard = PAL, Y/C, not VCR, intensity: 54, contrast: 54, saturation: 50 Display: PCI bus master, live video... not marked

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English 6.5.2 User z Use icon 39 to delete the relevant user from the list. Use the function symbols in the lower menu bar 41 for navigating within the list of defined users.

z Use icon 40 to change the adjustments for the relevant user.

z Use icon 38 to create a new user.

z Enter the login name of the user in field 42 . z Enter the desired password for the user in field 43 . z You may enter the complete name of the user in field 44 . z Mark the optional fields 45 for the access rights of the user by a mouse click acc. to your needs. For getting more details on user access rights, select the online help by pressing the ?-key or entering the search words "user" and "edit".

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