Eddy Full HD Digital Documentation System SOP-AIC-5001120

42 Pages·2012·1.76 MB·English

Aesculap Effective
®
Aesculap Endoscopic Technology
Instructions for use/Technical description Gebrauchsanweisung/Technische Beschreibung
Eddy Full HD Digital Documentation System Eddy Full HD Digitales Dokumentationssystem
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Document No.: TA022350 - Version: 1.0 - Document ID: SOP-AIC-5001120 Date/Time Printed/Viewed: 09/19/2012 18:10 (CET)
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Document No.: TA022350 - Version: 1.0 - Document ID: SOP-AIC-5001120 Date/Time Printed/Viewed: 09/19/2012 18:10 (CET)
Effective
Aesculap®
Eddy Full HD Digital Documentation System
Legend Eddy Full HD Digital DocumentatioAne sScyusltaepm® Symbols on product and packages
1 On/Standby switch
Caution, general warning symbol
2 On/Standby LED
Caution, see documentation supplied with the
3 Video recording START/STOP button product
4 Video recording START/STOP LED
Follow the instructions for use
5 DVD/CD drive
6 Read/Write LED on DVD/CD drive
7 EJECT button for ejecting the DVD/CD
Potential equalization terminal
8 Microphone socket (3.5-mm jack)
9 USB socket for external USB devices
10 TOUCH connector (RS232) for touch-screen monitor
Fuse
11 REMOTE connector for remote control on the camera head
12 Video output HD-SDI OUT (live image only)
On/Standby switch
13 Video input HD-SDI IN
14 Potential equalization terminal
15 IEC 320 mains power connector
Microphone socket
16 Fuse holder
17 ON/OFF switch
18 Video output DVI-D OUT
Marking of electric and electronic devices accord-
19 NETWORK connector (RJ45, Ethernet) for network cable
ing to directive 2002/96/EC (WEEE). see Disposal
20 USB socket for external USB devices
21 VGA interface (For service only)
22 DVI interface (For service only)
Date of manufacture
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Document No.: TA022350 - Version: 1.0 - Document ID: SOP-AIC-5001120 Date/Time Printed/Viewed: 09/19/2012 18:10 (CET)
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Contents
1. Safe handling 4 4.12 Menu Change patient data 25
2. Product description 4 4.13 Menu Data overview/View image 25
2.1 Scope of supply 4 4.14 Menu Data overview/Comment 26
2.2 Components required for operation 4 4.15 Menu Data overview/Video replay 26
2.3 Intended use 4 4.16 Writing data to DVD/CD or USB storage device 27
2.4 Operating principle 5 4.17 Data folder structure and file formats 28
3. Preparation and setup 5 4.18 Printing a report 28
3.1 First use 5 4.19 Operating the printer 29
3.2 Installing the device 7 4.20 Turning off Eddy Full HD 29
3.3 Connecting the accessories 8 4.21 Eddy Full HD image viewing software 29
3.4 Connecting the power supply 8 5. Validated reprocessing procedure 31
3.5 Software configuration in menu “Settings” 8 5.1 Cleaning/disinfection 31
3.6 Setting up a network connection 8 5.2 Inspection, maintenance and checks 32
3.7 Switching on Eddy Full HD and configuring the software 8 6. Maintenance 32
4. Working with the Eddy Full HD PV840 18 7. Troubleshooting list 32
4.1 System set-up 18 7.1 Notifications from Eddy Full HD 32
4.2 Safe operation 18 7.2 Network messages 35
4.3 Explanation of the control elements on the screen 18 7.3 Other prompts 35
4.4 Inserting a DVD/CD 19 8. Fuse replacement 37
4.5 Creating a new patient 20 9. Technical Service 37
4.6 Creating a new surgeon or new operation 21 10. Accessories/Spare parts 38
4.7 Menu Surgeon or Operation 21 11. Technical data 38
4.8 Menu Find patient 22 11.1 Ambient conditions 39
4.9 Recording still images, video sequences and sound 22 12. Disposal 39
4.10 Menu Live image 23 13. Distributor in the US/Contact in Canada for product
4.11 Menu Data overview 24 information and complaints 39
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Document No.: TA022350 - Version: 1.0 - Document ID: SOP-AIC-5001120 Date/Time Printed/Viewed: 09/19/2012 18:10 (CET)
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Aesculap®
Eddy Full HD Digital Documentation System
1. Safe handling 2. Product description
CAUTION
Federal law restricts this device to sale by, or on order of a physician! 2.1 Scope of supply
Risk of fatal injury from electric shock!
Designation Art. no.
► Do not open the product.
DANGER ► Connect the product only to a grounded power Eddy Full HD PV840
supply.
Instructions for use Eddy Full HD TA022350
PV840
Risk of injury caused by incorrect operation of the
product! Brief instructions for use TA022351
WARNING ► Attend appropriate product training before Notes on Electromagnetic Com- TA022130
using the product.
patibility
► For information about product training, please
DVI cable, 3 m PV820201
contact your national B.Braun/ Aesculap
agency. Optical mouse -
Note Serial cable for touch monitor, 3 m -
To operate the monitor and the camera system which will be connected to Remote control cable, 1m -
Eddy Full HD, refer to the instructions for use of the respective products.
HD-SDI Cable, 1 m -
These instructions for use only describe the handling of the product "Eddy
Full HD PV840”. HD-SDI Cable, 3 m -
► Only transport the product in its original packaging. CD containing instructions for use -
► Thoroughly clean the new product after removing its transport pack- and MPEG2 codec
aging and prior to first use.
► Prior to use, check that the product is in good working order.
► Observe “Notes on Electromagnetic Compatibility (EMC)“, see 2.2 Components required for operation
TA022130.
In addition to the documentation system, the following components are
► To prevent damage caused by improper setup or operation, and in order required for documenting and visualizing a medical intervention:
preserve warranty and manufacturer liability: ■ Country-specific power cord
– Ensure that the device does not come in direct contact with the ■ HD monitor with DVI video input
patient or in the sterile area.
■ Video camera system with HD SDI output
– Follow the safety and maintenance instructions.
Details regarding supported resolutions, see Technical data.
► Ensure that the product and its accessories are operated and used only
by persons with the requisite training, knowledge, or experience.
► Keep the instructions for use accessible for the user. 2.3 Intended use
► Always adhere to applicable standards. Eddy Full HD is a digital documentation system for displaying, recording,
► Ensure that the device does not come in direct contact with the patient documenting, archiving and sending medical still images and video
or in the sterile area respectively. sequences on stationary or mobile data media.
Note
Eddy Full HD may only be used for documentation purposes. The docu-
mented images are not licensed for use in diagnosis and/or therapy.
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Document No.: TA022350 - Version: 1.0 - Document ID: SOP-AIC-5001120 Date/Time Printed/Viewed: 09/19/2012 18:10 (CET)
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2.4 Operating principle 3.1 First use
The video signal is read in through the video input (parallel to real-time
display through the video output) and saved as BMP- and JPG-format or Risk of injury and/or product malfunction due to
as MPEG2-format video sequences. incorrect operation of the electromedical system!
The data can be directly recorded on the local hard drive, DVD-RAM, USB WARNING ► Adhere to the instructions for use of any medi-
storage media or network storage. cal device.
After the operation, the data can be written either to a DVD (DVD±R,
DVD±RW, DVD±R DL, DVD-RAM), CD or to a USB storage medium, or saved Eddy Full HD installation
on a network server via NetBEUI, FTP or DICOM protocol (only with ► Place Eddy Full HD on a level surface.
Aesculap DICOM Upgrade Set PV942).
► At least 5 cm on all sides from other devices (especially from high fre-
The data saved locally on the hard disk should be deleted, as Eddy Full HD quency-surgical devices, e.g. monopolar or bipolar diathermy).
is not designed for permanent data storage.
► Position Eddy Full HD as close as possible between the video camera
With integrated patient data management, it allows safe allocation of system and the monitor.
stills and video sequences to individual patients.
The operating concept of Eddy Full HD is optimised for the operation of
The system is operated with the assistance of Eddy Full HD documentation the system via a 24" touch screen monitor (PV956). Since Eddy Full HD is
software (Eddy = Endoscopic Digital Documentation sYstem), which was capable of displaying live images and documentation elements at the
specially developed for the requirements and procedures in the operating same time without loss of quality Eddy Full HD may also be operated with
room. the use of two monitors. As an alternative to the touch screen function-
ality, Eddy Full HD can also be controlled by using a USB keyboard and
mouse.
3. Preparation and setup
Non-compliance with the following instructions will preclude all respon-
sibility and liability in this respect on the part of Aesculap.
► When setting up and operating the product, adhere to
– national regulations for installation and operation,
– national regulations on fire and explosion protection.
Note
For the safety of patients and users it is essential that the mains power cord
and, especially, the protective earth connection are intact. In many cases
defective or missing protective earth connections are not registered imme-
diately.
► Connect the device via the potential equalization terminal at the rear
panel of the device to the potential equalization system of the room
used for medical purposes.
Note
The potential equalization lead can be ordered from the manufacturer as
art. no. GK535 (4 m length) or TA008205 (0.8 m length).
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Document No.: TA022350 - Version: 1.0 - Document ID: SOP-AIC-5001120 Date/Time Printed/Viewed: 09/19/2012 18:10 (CET)
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Aesculap®
Eddy Full HD Digital Documentation System
Operating with a monitor Operating with two monitors
In the event of the live image being absent due to
failure/turn off the Eddy Full HD.
WARNING ► Ensure that both monitor video outputs of Eddy
Full HD (HD-SDI OUT and DVI-D OUT) are con-
nected.
Fig. 2
Legend
A DICOM-Dongle PV842 (optional)
B Potential equalization (domestic installation)
C Power supply (domestic installation)
D Ethernet (domestic installation) (optional)
Fig. 1
E USB devices (optional)
Legend
A DICOM-Dongle PV842 (optional) Connecting the camera control unit
B Potential equalization (domestic installation) Note
C Power supply (domestic installation) Only use insulated cables, see chapter accessories/spare components.
D Ethernet (domestic installation) (optional)
► Connect HD-SDI video output of the camera control unit with video
E USB devices (optional)
input HD-SDI IN 13 of Eddy Full HD.
► Connect the remote control cable, see Accessories/Spare parts, to the
remote connector of the camera control unit and REMOTE
connector11 of Eddy Full HD.
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Document No.: TA022350 - Version: 1.0 - Document ID: SOP-AIC-5001120 Date/Time Printed/Viewed: 09/19/2012 18:10 (CET)
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Connecting the monitor or touch-screen monitor to operate the soft- Connecting a printer (optional)
ware
Eddy Full HD has the option of connecting to a USB printer to print reports.
Note ► Connect the USB printer cable to the USB socket of the printer.
The documentation software of Eddy Full HD is shown on the monitor con- ► Connect the USB printer cable to the USB socket 20 of Eddy Full HD.
nected via DVI.
► Connect the mains power cord to the external power supply and plug
in to a mains power socket.
Note
When turning on Eddy Full HD, the monitor must be plugged in and turned ► Setting the printer as default printer, see Install printer.
on. The following printers have been pre-installed and can be used without
installation:
► Connect video output DVI-D OUT18 of Eddy Full HD to the DVI-D cable ■ SONY UP-DR80MD (PV986)
on the DVI input of the monitor. ■ HP Deskjet 1000
► Connect TOUCH terminal 10 of Eddy Full HD with the SERIAL CONTROL ■ HP Officejet 6000
interface of the monitor PV956 with the appropriate cable, see Acces-
In principal, it is possible to connect to additional USB printers and install
sories/Spare parts.
appropriate drivers. The installation of additional printers is described
below, see Install printer.
Connecting a second monitor for live image display (optional)
► Connect video output HD-SDI OUT19 of Eddy Full HD with the video Connecting the mains power cord and equipotentialization cable
HD-SDI input of the monitor with the appropriate cable, see Accesso-
Note
ries/Spare parts.
The mains voltage must correspond to the voltage indicated on the type
plate at the back of the unit.
Connecting the mouse
All functions of the Eddy Full HD can be comfortably controlled through a ► Plug in the power cord at power connector15 of Eddy Full HD. To con-
touch-screen monitor. In setups without a touch-screen monitor, all func- nect the cable, see Accessories/Spare parts.
tions can be selected with the mouse. ► Connect the mains plug of the power cord to the building mains.
In any case, Aesculap recommends connecting the mouse as an additional ► Plug in the equipotential bonding cable to the power connector 14 of
input device. Eddy Full HD.
► Connect the USB mouse to a USB socket 20 of Eddy Full HD. ► Connect the plug of the equipotential bonding cable to the domestic
installation.
Connecting an external keyboard (optional)
All functions of the Eddy Full HD can be comfortably controlled through a
3.2 Installing the device
touch-screen monitor. In setups without a touch-screen monitor, an
external keyboard can be used as an alternative input device. ► Ensure sufficient stability of the carrier.
► Connect the USB keyboard to a USB socket 20 of Eddy Full HD.
Connecting a microphone (optional)
As another option, to record sound accompanying video recording, a
microphone with a 3.5-mm jack connector can be connected to Eddy full
HD.
► Plug in the microphone to microphone socket 8 in the front panel.
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Document No.: TA022350 - Version: 1.0 - Document ID: SOP-AIC-5001120 Date/Time Printed/Viewed: 09/19/2012 18:10 (CET)
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Aesculap®
Eddy Full HD Digital Documentation System
3.3 Connecting the accessories 3.6 Setting up a network connection
Risk of injury due to unapproved configuration Risk of injury from unpredictable currents after
using additional components! establishing the network connection! NETWORK
DANGER ► For all applied components, ensure that their WARNING connector 17 does not have galvanic isolation.
classification matches that of the application ► To produce galvanic isolation, connect with the
component (e.g. Type BF or Type CF) of the network first (via network isolator).
respective device.
If data are to be saved through the network in a shared folder on a spec-
Combinations of accessories that are not mentioned in the present ified computer, the system administrator can link Eddy Full HD to a net-
instructions for use may only be employed if they are specifically intended work.
for the respective application, and if they do not compromise the perfor- ► Connect the network cable between NETWORK connector18 and net-
mance and safety characteristics of the products. work wall socket.
Also note that any equipment connected at the interfaces must demon- ► Create a shared folder for saving the Eddy Full HD data on the selected
strably meet the respective IEC standards (e.g. IEC 60950 for data process- computer in the network.
ing equipment, IEC/DIN EN 60601-1 for electromedical devices).
All configurations must comply with basic standard IEC/DIN EN60601-1.
Any individual connecting devices with one another is responsible for such 3.7 Switching on Eddy Full HD and configuring the
configuration and must ensure compliance with basic standard IEC/DIN software
EN60601-1 or applicable national standards.
► Switch the monitor on.
► Please address your B. Braun/Aesculap partner or Aesculap Technical
► Switch on Eddy Full HD at On/Standby switch 1.
Service with any inquiries in this respect; for a contact address,see
As soon as Eddy Full HD is ready, the start page is displayed, see Fig. 3:
Technical Service.
3.4 Connecting the power supply
Risk of fatal injury from electric shock!
► Connect the product only to a grounded power
DANGER supply.
3.5 Software configuration in menu “Settings”
Once the Eddy Full HD has been installed and connected, the software
must to be configured through the “Settings” menu.
► General settings should be configured by trained personnel.
Fig. 3
► Network and system settings should be configured by the system
administrator. ► Select “Settings button.
Menu “Settings/General” is displayed.
Note
The following is a detailed description of the individual menus and possible
settings.
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Document No.: TA022350 - Version: 1.0 - Document ID: SOP-AIC-5001120 Date/Time Printed/Viewed: 09/19/2012 18:10 (CET)
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Menu “Settings/General” Menu “Settings/Video”
Fig. 4 Fig. 5
Hospital Enter hospital name. Automatically displayed Image format Select image format.
pre-selection; automatically allocated to all BMP
patient data. Save the images in BMP format only.
JPEG
Logo Inserts individual logo to be printed in the top
to save images in JPEG format only.
right corner of every report.
JPEG = high quality, compressed
The logo must exist as a bitmap file or JPEG file
BMP = highest quality, not compressed
with the file name “Logo.bmp” or "logo.jpg" in
the root directory of a USB device or a CD. Con- Video quality Select video quality/Compression rate:
vert the logo to a suitable format (width: - High = approx. 1 h video per DVD DL
height should be a approx. a factor of 3) load - Medium = approx. 1.5 h video per DVD DL
the Eddy Full HD logo with a USB device or - Low = approx. 2 h video per DVD DL
DVD/CD. Press button “Import logo”. The mes-
sage "importing finished" appears".
Save/Start page Save settings and switch to start page.
Format of date Select format of date:
Reject/Start page Switch to start page without saving.
- DD.MM.YYYY = European format
- MM/DD/YYYY = US format
DD=Day in two-digit numerical representation
MM=Month in two-digit numerical represen-
tation
YYYY=Year in four-digit numerical representa-
tion
Date/Time Enter present date and time.
Language Select language: German, English, French, Ital-
ian, Spanish, Czech
Save/Start page Save settings and switch to start page.
Reject/Start page Switch to start page without saving.
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Document No.: TA022350 - Version: 1.0 - Document ID: SOP-AIC-5001120 Date/Time Printed/Viewed: 09/19/2012 18:10 (CET)