Eddy Full HD Digital Documentation System SOP-AIC

Aesculap®
Effective
Aesculap Endoscopic Technology
Instructions for use/Technical description
Gebrauchsanweisung/Technische Beschreibung
Eddy Full HD Digital Documentation System
Eddy Full HD Digitales Dokumentationssystem
Effective
Document No.: TA022350 - Version: 1.0 - Document ID: SOP-AIC-5001120 Date/Time Printed/Viewed: 09/19/2012 18:10 (CET)
Effective
Effective
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
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
On/Standby switch
On/Standby LED
Video recording START/STOP button
Video recording START/STOP LED
DVD/CD drive
Read/Write LED on DVD/CD drive
EJECT button for ejecting the DVD/CD
Microphone socket (3.5-mm jack)
USB socket for external USB devices
TOUCH connector (RS232) for touch-screen monitor
REMOTE connector for remote control on the camera head
Video output HD-SDI OUT (live image only)
Video input HD-SDI IN
Potential equalization terminal
IEC 320 mains power connector
Fuse holder
ON/OFF switch
Video output DVI-D OUT
NETWORK connector (RJ45, Ethernet) for network cable
USB socket for external USB devices
VGA interface (For service only)
DVI interface (For service only)
Eddy Full HD Digital Documentation
Aesculap
System®
Symbols on product and packages
Caution, general warning symbol
Caution, see documentation supplied with the
product
Follow the instructions for use
Potential equalization terminal
Fuse
On/Standby switch
Microphone socket
Marking of electric and electronic devices according to directive 2002/96/EC (WEEE). see Disposal
Date of manufacture
Effective
2
Document No.: TA022350 - Version: 1.0 - Document ID: SOP-AIC-5001120 Date/Time Printed/Viewed: 09/19/2012 18:10 (CET)
Effective
Contents
1.
2.
2.1
2.2
2.3
2.4
3.
3.1
3.2
3.3
3.4
3.5
3.6
3.7
4.
4.1
4.2
4.3
4.4
4.5
4.6
4.7
4.8
4.9
4.10
4.11
Safe handling
Product description
Scope of supply
Components required for operation
Intended use
Operating principle
Preparation and setup
First use
Installing the device
Connecting the accessories
Connecting the power supply
Software configuration in menu “Settings”
Setting up a network connection
Switching on Eddy Full HD and configuring the software
Working with the Eddy Full HD PV840
System set-up
Safe operation
Explanation of the control elements on the screen
Inserting a DVD/CD
Creating a new patient
Creating a new surgeon or new operation
Menu Surgeon or Operation
Menu Find patient
Recording still images, video sequences and sound
Menu Live image
Menu Data overview
4
4
4
4
4
5
5
5
7
8
8
8
8
8
18
18
18
18
19
20
21
21
22
22
23
24
4.12
4.13
4.14
4.15
4.16
4.17
4.18
4.19
4.20
4.21
5.
5.1
5.2
6.
7.
7.1
7.2
7.3
8.
9.
10.
11.
11.1
12.
13.
Menu Change patient data
Menu Data overview/View image
Menu Data overview/Comment
Menu Data overview/Video replay
Writing data to DVD/CD or USB storage device
Data folder structure and file formats
Printing a report
Operating the printer
Turning off Eddy Full HD
Eddy Full HD image viewing software
Validated reprocessing procedure
Cleaning/disinfection
Inspection, maintenance and checks
Maintenance
Troubleshooting list
Notifications from Eddy Full HD
Network messages
Other prompts
Fuse replacement
Technical Service
Accessories/Spare parts
Technical data
Ambient conditions
Disposal
Distributor in the US/Contact in Canada for product
information and complaints
25
25
26
26
27
28
28
29
29
29
31
31
32
32
32
32
35
35
37
37
38
38
39
39
39
Effective
3
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
1.
Safe handling
CAUTION
Federal law restricts this device to sale by, or on order of a physician!
Risk of fatal injury from electric shock!
► Do not open the product.
► Connect the product only to a grounded power
supply.
2.
Product description
2.1
Scope of supply
Designation
Art. no.
Eddy Full HD
PV840
Instructions for use Eddy Full HD
PV840
TA022350
Brief instructions for use
TA022351
Notes on Electromagnetic Compatibility
TA022130
DVI cable, 3 m
PV820201
Optical mouse
-
Note
To operate the monitor and the camera system which will be connected to
Eddy Full HD, refer to the instructions for use of the respective products.
These instructions for use only describe the handling of the product "Eddy
Full HD PV840”.
Serial cable for touch monitor, 3 m
-
Remote control cable, 1 m
-
HD-SDI Cable, 1 m
-
HD-SDI Cable, 3 m
-
► Only transport the product in its original packaging.
CD containing instructions for use
and MPEG2 codec
-
DANGER
WARNING
Risk of injury caused by incorrect operation of the
product!
► Attend appropriate product training before
using the product.
► For information about product training, please
contact your national B. Braun/ Aesculap
agency.
► Thoroughly clean the new product after removing its transport pack-
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
►
►
►
►
►
TA022130.
To prevent damage caused by improper setup or operation, and in order
preserve warranty and manufacturer liability:
– Ensure that the device does not come in direct contact with the
patient or in the sterile area.
– Follow the safety and maintenance instructions.
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.
Always adhere to applicable standards.
Ensure that the device does not come in direct contact with the patient
or in the sterile area respectively.
2.2
Components required for operation
In addition to the documentation system, the following components are
required for documenting and visualizing a medical intervention:
■ Country-specific power cord
■ HD monitor with DVI video input
■ Video camera system with HD SDI output
Details regarding supported resolutions, see Technical data.
2.3
Intended use
Eddy Full HD is a digital documentation system for displaying, recording,
documenting, archiving and sending medical still images and video
sequences on stationary or mobile data media.
Note
Eddy Full HD may only be used for documentation purposes. The documented images are not licensed for use in diagnosis and/or therapy.
Effective
4
Document No.: TA022350 - Version: 1.0 - Document ID: SOP-AIC-5001120 Date/Time Printed/Viewed: 09/19/2012 18:10 (CET)
Effective
2.4
Operating principle
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
as MPEG2-format video sequences.
The data can be directly recorded on the local hard drive, DVD-RAM, USB
storage media or network storage.
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
on a network server via NetBEUI, FTP or DICOM protocol (only with
Aesculap DICOM Upgrade Set PV942).
The data saved locally on the hard disk should be deleted, as Eddy Full HD
is not designed for permanent data storage.
With integrated patient data management, it allows safe allocation of
stills and video sequences to individual patients.
The system is operated with the assistance of Eddy Full HD documentation
software (Eddy = Endoscopic Digital Documentation sYstem), which was
specially developed for the requirements and procedures in the operating
room.
3.
3.1
First use
WARNING
Risk of injury and/or product malfunction due to
incorrect operation of the electromedical system!
► Adhere to the instructions for use of any medical device.
Eddy Full HD installation
► Place Eddy Full HD on a level surface.
► At least 5 cm on all sides from other devices (especially from high fre-
quency-surgical devices, e. g. monopolar or bipolar diathermy).
► Position Eddy Full HD as close as possible between the video camera
system and the monitor.
The operating concept of Eddy Full HD is optimised for the operation of
the system via a 24" touch screen monitor (PV956). Since Eddy Full HD is
capable of displaying live images and documentation elements at the
same time without loss of quality Eddy Full HD may also be operated with
the use of two monitors. As an alternative to the touch screen functionality, Eddy Full HD can also be controlled by using a USB keyboard and
mouse.
Preparation and setup
Non-compliance with the following instructions will preclude all responsibility 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 immediately.
► 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).
Effective
5
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
Operating with a monitor
WARNING
Operating with two monitors
In the event of the live image being absent due to
failure/turn off the Eddy Full HD.
► Ensure that both monitor video outputs of Eddy
Full HD (HD-SDI OUT and DVI-D OUT) are connected.
Fig. 2
Fig. 1
Legend
A DICOM-Dongle PV842 (optional)
B Potential equalization (domestic installation)
C Power supply (domestic installation)
D Ethernet (domestic installation) (optional)
E USB devices (optional)
Legend
A DICOM-Dongle PV842 (optional)
B Potential equalization (domestic installation)
C Power supply (domestic installation)
D Ethernet (domestic installation) (optional)
E USB devices (optional)
Connecting the camera control unit
Note
Only use insulated cables, see chapter accessories/spare components.
► Connect HD-SDI video output of the camera control unit with video
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
connector 11 of Eddy Full HD.
Effective
6
Document No.: TA022350 - Version: 1.0 - Document ID: SOP-AIC-5001120 Date/Time Printed/Viewed: 09/19/2012 18:10 (CET)
Effective
Connecting the monitor or touch-screen monitor to operate the software
Note
The documentation software of Eddy Full HD is shown on the monitor connected via DVI.
Note
When turning on Eddy Full HD, the monitor must be plugged in and turned
on.
► Connect video output DVI-D OUT 18 of Eddy Full HD to the DVI-D cable
on the DVI input of the monitor.
► Connect TOUCH terminal 10 of Eddy Full HD with the SERIAL CONTROL
interface of the monitor PV956 with the appropriate cable, see Accessories/Spare parts.
Connecting a second monitor for live image display (optional)
► Connect video output HD-SDI OUT 19 of Eddy Full HD with the video
HD-SDI input of the monitor with the appropriate cable, see Accessories/Spare parts.
Connecting the mouse
All functions of the Eddy Full HD can be comfortably controlled through a
touch-screen monitor. In setups without a touch-screen monitor, all functions can be selected with the mouse.
In any case, Aesculap recommends connecting the mouse as an additional
input device.
► Connect the USB mouse to a USB socket 20 of Eddy Full HD.
Connecting a printer (optional)
Eddy Full HD has the option of connecting to a USB printer to print reports.
► Connect the USB printer cable to the USB socket of the printer.
► Connect the USB printer cable to the USB socket 20 of Eddy Full HD.
► Connect the mains power cord to the external power supply and plug
in to a mains power socket.
► Setting the printer as default printer, see Install printer.
The following printers have been pre-installed and can be used without
installation:
■ SONY UP-DR80MD (PV986)
■ HP Deskjet 1000
■ HP Officejet 6000
In principal, it is possible to connect to additional USB printers and install
appropriate drivers. The installation of additional printers is described
below, see Install printer.
Connecting the mains power cord and equipotentialization cable
Note
The mains voltage must correspond to the voltage indicated on the type
plate at the back of the unit.
► Plug in the power cord at power connector 15 of Eddy Full HD. To con-
nect the cable, see Accessories/Spare parts.
► Connect the mains plug of the power cord to the building mains.
► Plug in the equipotential bonding cable to the power connector 14 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
touch-screen monitor. In setups without a touch-screen monitor, an
external keyboard can be used as an alternative input device.
► Connect the USB keyboard to a USB socket 20 of Eddy Full HD.
3.2
Installing the device
► Ensure sufficient stability of the carrier.
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.
Effective
7
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
3.3
Connecting the accessories
DANGER
Risk of injury due to unapproved configuration
using additional components!
► For all applied components, ensure that their
classification matches that of the application
component (e.g. Type BF or Type CF) of the
respective device.
Combinations of accessories that are not mentioned in the present
instructions for use may only be employed if they are specifically intended
for the respective application, and if they do not compromise the performance and safety characteristics of the products.
Also note that any equipment connected at the interfaces must demonstrably meet the respective IEC standards (e.g. IEC 60950 for data processing equipment, IEC/DIN EN 60601-1 for electromedical devices).
All configurations must comply with basic standard IEC/DIN EN 60601-1.
Any individual connecting devices with one another is responsible for such
configuration and must ensure compliance with basic standard IEC/DIN
EN 60601-1 or applicable national standards.
► Please address your B. Braun/Aesculap partner or Aesculap Technical
Service with any inquiries in this respect; for a contact address, see
Technical Service.
3.4
Setting up a network connection
WARNING
Risk of injury from unpredictable currents after
establishing the network connection! NETWORK
connector 17 does not have galvanic isolation.
► To produce galvanic isolation, connect with the
network first (via network isolator).
If data are to be saved through the network in a shared folder on a specified computer, the system administrator can link Eddy Full HD to a network.
► Connect the network cable between NETWORK connector 18 and network wall socket.
► Create a shared folder for saving the Eddy Full HD data on the selected
computer in the network.
3.7
Switching on Eddy Full HD and configuring the
software
► Switch the monitor on.
► Switch on Eddy Full HD at On/Standby switch 1.
As soon as Eddy Full HD is ready, the start page is displayed, see Fig. 3:
Connecting the power supply
DANGER
3.5
3.6
Risk of fatal injury from electric shock!
► Connect the product only to a grounded power
supply.
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.
► Network and system settings should be configured by the system
administrator.
Fig. 3
► Select “Settings button.
Menu “Settings/General” is displayed.
Note
The following is a detailed description of the individual menus and possible
settings.
Effective
8
Document No.: TA022350 - Version: 1.0 - Document ID: SOP-AIC-5001120 Date/Time Printed/Viewed: 09/19/2012 18:10 (CET)
Effective
Menu “Settings/General”
Menu “Settings/Video”
Fig. 4
Fig. 5
Hospital
Enter hospital name. Automatically displayed
pre-selection; automatically allocated to all
patient data.
Logo
Inserts individual logo to be printed in the top
right corner of every report.
The logo must exist as a bitmap file or JPEG file
with the file name “Logo.bmp” or "logo.jpg" in
the root directory of a USB device or a CD. Convert the logo to a suitable format (width:
height should be a approx. a factor of 3) load
the Eddy Full HD logo with a USB device or
DVD/CD. Press button “Import logo”. The message "importing finished" appears".
Format of date
Select format of date:
- DD.MM.YYYY = European format
- MM/DD/YYYY = US format
DD=Day in two-digit numerical representation
MM=Month in two-digit numerical representation
YYYY=Year in four-digit numerical representation
Date/Time
Enter present date and time.
Language
Select language: German, English, French, Italian, Spanish, Czech
Save/Start page
Save settings and switch to start page.
Reject/Start page
Switch to start page without saving.
Image format
Select image format.
BMP
Save the images in BMP format only.
JPEG
to save images in JPEG format only.
JPEG = high quality, compressed
BMP = highest quality, not compressed
Video quality
Select video quality/Compression rate:
- High
= approx. 1 h video per DVD DL
- Medium
= approx. 1.5 h video per DVD DL
- Low
= approx. 2 h video per DVD DL
Save/Start page
Save settings and switch to start page.
Reject/Start page
Switch to start page without saving.
Effective
9
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
Menu “Settings/Camera”
Menu Settings/Printer
Note
For the function "image and video", the camera system must support the
remote time function.
Fig. 7
Auto print
Fig. 6
Remote button function
Select image or video function:
- Image (still)
- Video (Start/Stop video recording)
- Sound on (acoustic signal)
with a remote control cable connected, via the
remote control button on the camera head.
Image and video:
- Press camera remote control button briefly
(<2 s):
Still image is saved
- Press camera remote control button (>2 s)
long:
Video recording is started or stopped.
Individual images can still be captured during
video recording (by briefly (<2 s) pressing the
camera remote control button).
If the auto print function is activated, still "live
images" are automatically generated and
printed once the appropriate number of still
images of the selected layout is achieved.
■
Off: The auto print function is deactivated.
– Note - When activating the auto print
function, the patients data is located on
the first page.
■
■
■
3 images per page: When the auto print
function is activated, 3 images per page are
printed.
4 images per page: When the auto print
function is activated, 4 images per page are
printed.
8 images per page: When the auto print
function is activated, 8 images per page are
printed.
Save/Start page
Save settings and switch to start page.
Open
System printer
Settings
Open the Windows printer control panel to
install an additional printer or to set the default
printer.
Reject/Start page
Switch to start page without saving.
Save system state
Saves the current state of the system and
reboots the system.
Save/Start page
Save settings and switch to start page.
Reject/Start page
Switch to start page without saving.
Effective
10
Document No.: TA022350 - Version: 1.0 - Document ID: SOP-AIC-5001120 Date/Time Printed/Viewed: 09/19/2012 18:10 (CET)
Effective
► Select OK to confirm the message.
Install printer
► The window Printers and Faxes appears, see Fig. 9.
CAUTION
There is risk of possible damage/failure of the
devices by installing an additional printer or driver!
► Use the pre-installed printer or printer driver.
► System printer settings should be only changed
by specialist IT personnel.
Note
Installation of additional printer or printer driver is the responsibility of the
operator!
Note
Changes to the operating system are retained only when save system state
is chosen, see Save system status.
► Press button Open system printer settings.
A message appears, see Fig. 8.
Fig. 9
► Connect the printer via USB cable to the USB socket 20.
► Power on the printer.
The window Found New Hardware Wizard appears.
► Click No, not this time, see Fig. 10.
► Select Next button.
Fig. 8
Fig. 10
Effective
11
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
The next step in the Found New Hardware Wizard appears.
► Insert the CD with printer drivers into your DVD/CD drive 5.
► Select Install from a list or specific location (Advanced).
The last step of the Found New Hardware Wizard appears after all the
data has been copied, see Fig. 13.
► Select finish button.
► Select Next button, see Fig. 11.
Fig. 13
Fig. 11
► Select Search removable media (floppy, CD-ROM…), see Fig. 12.
► If a list appears with several printer drivers, select the correct printer.
The installation is successfully completed.
► Ensure that the printer is set as the default printer (as indicated by the
gray hooks, see Fig. 14).
► Select Next button.
Fig. 14
Fig. 12
Effective
12
Document No.: TA022350 - Version: 1.0 - Document ID: SOP-AIC-5001120 Date/Time Printed/Viewed: 09/19/2012 18:10 (CET)
Effective
Setting as default printer
Save system status
Note
Changes to the operating system are retained only when save system state
is chosen, see Save system status.
System settings need to be saved after touch screen calibration, changes
to the network settings, installation of a new printer or changing the
default printer.
► Select Save system status, see Fig. 16.
► Open the window Printers and Faxes, see Install printer.
► Select the desired printer
► Select menu File -> Set as Default Printer, see Fig. 15.
► Close the window Printers and Faxes.
Fig. 16
► Select OK to confirm the message, see Fig. 17.
Fig. 15
Fig. 17
► Wait until Eddy Full HD reboots the system and the start screen
appears.
Effective
13
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
Touchscreen menu
Calibrate touch screen
Note
If its not possible to use the monitor with touch screen functionality, the
USB mouse must be connected in order to enter the calibration routine.
Note
If the operation monitor's over scan level changes, a new calibration of the
touch screen is required.
The calibration is carried out when the screen is in a misaligned condition.
► Select Calibrate touch screen.
A message appears, see Fig. 19.
Fig. 18
Mouse cursor on live
image
■
■
■
Always invisible: The mouse pointer is never
visible in the live images.
Visible for 10 seconds and then invisible. The
mouse pointer is visible in the live image for
10 seconds after the last use.
Always visible: The mouse pointer is always
visible in the live images.
Calibrate touch
screen
Starting the touch screen calibration see Calibrate touch screen.
Save system state
Saves the current state of the system and
reboots the system.
Save/Start page
Save settings and switch to start page.
Reject/Start page
Switch to start page without saving.
Fig. 19
► Select OK to start the calibration.
► Touch the target on the touch-screen monitor with a finger or a selec-
tion pen.
► Touch the touchscreen. The mouse pointer should jump to the point
touched on the screen.
if the calibration was successful.
► Select
if the calibration failed and needs to be run again.
► Save system status, see Save system status.
► Select
Effective
14
Document No.: TA022350 - Version: 1.0 - Document ID: SOP-AIC-5001120 Date/Time Printed/Viewed: 09/19/2012 18:10 (CET)
Effective
Menu Settings/System and Settings/Network
Menu Settings/Network/General
The menus Settings/Network and Settings/System are accessible only
for authorized password holders.
The system is supplied with the password preset to “OOOO”.
The system administrator must change the password in the Settings/System menu.
Password
Fig. 21
Fig. 20
Password
Enter password for access to menu Settings/Systems or Settings/Network.
OK
Confirm password.
Incorrect password
When an incorrect password is given Incorrect
Password appears in the message window.
Save/Start page
Save settings and switch to start page.
Reject/Start page
Switch to start page without saving.
IP address
Get IP address automatically (DHCP)
- or Without DHCP: Enter IP address for Eddy Full HD.
Subnet mask
Enter subnet mask (if necessary).
Gateway
Enter network gateway (if necessary).
Primary DNS
Enter primary Domain Name Server (DNS), if necessary.
Secondary DNS
Enter secondary Domain Name Server (DNS), if
necessary.
Save/Start page
Save settings and switch to start page.
Reject/Start page
Switch to start page without saving.
Effective
15
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
Menu Settings/Network/NetBEUI
Menu Settings/Network/DICOM
Note
For the DICOM-settings and functions, see TA022370 "Instructions for
DICOM 3.0 USB set for EDDY Full HD".
Menu Settings/Network/FTP
Fig. 22
Network drive
Enter shared folder on a computer in the network
in which Eddy Full HD will save its data (e.g.
\\server\share).
Network username
Enter the user authorized to access the network
drive (if necessary).
Network password
Enter password for the user who is authorized to
access the network drive.
Change network
domain
Change the network domain to which Eddy Full
HD belongs (if necessary).
Save system state
Saves the current state of the system and reboots
the system, see Save system status.
Save/Start page
Save settings and switch to start page.
Reject/Start page
Switch to start page without saving.
Note
As changes occur in relation to the network domain on the operating system level, the on-screen keyboard is not available, a USB keyboard is
needed for input.
Fig. 23
FTP Server and Port
Enter the name or IP-address and the port of the
FTP server.
Remote directory
Enter the directory on the FTP server.
FTP user name
Enter FTP user name.
FTP password
Enter FTP password.
Use passive mode
(PASV)
Select whether passive mode (PASV) is to be used.
Save/Start page
Save settings and switch to start page.
Reject/Start page
Switch to start page without saving.
Note
Changes to the operating system are only retained when the system status
is saved, see Save system status.
Effective
16
Document No.: TA022350 - Version: 1.0 - Document ID: SOP-AIC-5001120 Date/Time Printed/Viewed: 09/19/2012 18:10 (CET)
Effective
Menu Settings/Network/Test
Menu Settings/System
Fig. 24
Fig. 25
Test
NetBEUI connection
Eddy Full HD attempts to establish a connection
to the configured network drive.
Test
DICOM connection
(Echo Request)
Eddy DVD attempts to connect to the configured
PACS server to send a message (Verification SOP
Class).
Tests
FTP connection
Eddy DVD attempts establishing an FTP connection.
Save/Start page
Save settings and switch to start page.
Reject/Start page
Switch to start page without saving.
Change password
Enter a new password.
Repeat password
Repeat (confirm) entry of the new password.
Write log files to
DVD/USB
All log files are written to a DVD/CD or to an
external USB device to the folder EddyHD/logs to
be analyzed for troubleshooting in case of problems.
Version
Software and hardware version of the device
Serial number
Device's serial number
Save/Start page
Save settings and switch to start page.
Reject/Start page
Switch to start page without saving.
Effective
17
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
4.
Working with the Eddy Full HD PV840
4.1
System set-up
► Switch the camera system on.
4.2
Safe operation
CAUTION
► Switch the monitor on.
► Verify that the DVI video input selected on the monitor is the same as
the one connected to Eddy Full HD.
► If data is to be read in from the network: Make certain that the network cable is connected to NETWORK connector 19 and that the network connection is operational.
► Make certain that the mouse (and the external keyboard, if applicable)
is connected correctly.
► Press On/Standby switch 1 of Eddy Full HD.
The On/Standby LED 2 lights up.
Eddy Full HD starts. The start procedure will take approx. 40 s.
Eddy Full HD is ready as soon as the following start page is displayed
see Fig. 26.
Damage to the touch-screen monitor may occur by
touching it with a sharp object (e.g. a pencil or a
ballpoint)!
► Touch the touch screen with a finger or a selection pen only.
Eddy Full HD offers the following control functions:
■ Creating a new patient
■ Finding patient data
■ Recording still images, video sequences and sound
■ Managing data recorded on DVD/CD or USB storage devices, or through
the network
■ Printing a report
■ To change default settings, see the software chapter in the menu Settings
Note
To select a function, left click, touch the touchscreen or use the selector pen
on the touch screen monitor.
Note
All control functions are accessible through clicking with the left mouse
button or through touching the touch-screen monitor, if such a monitor is
part of the setup. The system can also be operated through a combination
of the input devices mouse, touch-screen monitor and keyboard.
4.3
Explanation of the control elements on the screen
The control elements on the screen are explained through the following
examples.
Fig. 26
► Select the respective menus via the buttons “New patient” or “Find
patient” on the navigation bar at the lower edge of the screen, to enter
the respective menus, see Safe operation.
Keys and buttons
Navigation bar
The navigation bar includes buttons for selecting the main functions.
Function checks
► Check that the Eddy Full HDstart page is displayed.
► Check that Eddy Full HD responds to the input devices (touch-screen
monitor or mouse and keyboard, if connected).
► After entering the first patient’s data, check that Live Image is dis-
played in the camera menu. Alternatively, a “test patient” can be
called.
Fig. 27
“Tab” key, “Return” key
The Tab or Return move the cursor to the next input field, the Return key
also produces a new line in the Comments field.
Fig. 28
Effective
18
Document No.: TA022350 - Version: 1.0 - Document ID: SOP-AIC-5001120 Date/Time Printed/Viewed: 09/19/2012 18:10 (CET)
Effective
“Alt” key
Light blue input field
The Alt key switches the keyboard display on the screen to special characters display.
After selecting a special character, the keyboard switches back to standard
characters.
The current active field, where the cursor appears, is displayed in light blue
see Fig. 34.
Fig. 34
Gray info field
Fig. 29
This field just shows information (e.g. DD.MM.YYYY), but cannot be edited.
“Up” and “Down” keys
The "Up" and "Down" keys open and close multi-line fields or scroll up or
down.
Fig. 35
4.4
Inserting a DVD/CD
Fig. 30
Light gray button
The light gray button is inactive in this operating situation and has no
function.
Fig. 31
Fields
CAUTION
Loss of data saved on DVD/CD!
► Only use clean and dry DVDs/CDs.
► Do not touch, stain or scratch the recording
side.
► Do not stick labels on DVD/CD. Only inscribe
with a soft fiber pen.
► If necessary, clean the recording side with a soft
dry tissue.
► Store CDs and DVDs in a CD-pouch or protective
sleeve.
Blue input field
► Press EJECT button 7.
This input field is mandatory, and must be completed, otherwise a message will be displayed (compulsory input).
► Insert the DVD/CD, with the print side up, into DVD/CD drive 5 until the
The DVD/CD inserted in DVD/CD drive 5 is ejected.
DVD/CD is automatically pulled into the drive.
Fig. 32
White input field
This input field may be filled if required by the user, but is optional (e.g.
comments).
Note
After the DVD/CD is fully inserted, it will still take a few moments for Eddy
Full HD to read and process the disk. During this period, the Read/WriteLED 6 will keep flashing. Only after this, the DVD/CD is ready for data reading or writing.
Fig. 33
Effective
19
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
4.5
Creating a new patient
Possible messages
► Select button New patient
on the start page.
The menu New patient is displayed.
► Enter the patient data as described below, see Menu New patient.
Menu New patient
Fig. 37
Please fill in ID
number
The data will only be saved if the field ID-Number
was filled out correctly.
Fig. 36
ID number
(mandatory input)
Enter the patient’s ID number.
Name (mandatory
input)
Enter the patient’s surname.
First name
Enter the patient’s first name.
Date of birth
Enter the patient’s date of birth.
Surgeon
Enter the surgeon’s name.
- or Open the drop down list.
A selection list of the last 100 surgeons that were
entered is displayed.
Operation
Enter the kind of operation.
- or Open the drop down list.
A selection list of the last 100 operations entered
is displayed.
Notes
Enter notes if desired. More lines for notes can be
created by pressing the Return key.
Start page
Save the input data and switch to the start page.
Save/New patient
Save entered data and switch to new, empty
menu “New patient”.
Save/Live image
Save the entered data and then display the live
image for this patient.
Fig. 38
Please fill in name The data will only be saved if the field Name was
filled out correctly.
Fig. 39
ID number already
exists
Data cannot be saved if the entered ID number has
already been allocated to another patient. Enter
unique ID number and confirm with OK.
Effective
20
Document No.: TA022350 - Version: 1.0 - Document ID: SOP-AIC-5001120 Date/Time Printed/Viewed: 09/19/2012 18:10 (CET)
Effective
4.6
Creating a new surgeon or new operation
► Select the appropriate button
Finding patient data
in the menu “New patient” or menu
"Change patient".
The menu "surgeon" or "operation" is displayed.
► Creating a new surgeon or new operation see Menu Surgeon or Operation.
4.7
Menu Surgeon or Operation
Patient data from a previous session with Eddy Full HD, stored either from
the system hard drive, a DVD, CD, USB storage device, or from the network, can be accessed and read via the Find patient menu.
Note
To access data from the network, the network connection must have been
established before Eddy Full HD was started.
When data is to be read from a DVD/CD, it can take a few moments after
inserting the DVD/CD until Eddy Full HD has read and processed the data.
During this period, the Read/Write-LED 6 will keep flashing.
► Ensure that the correct DVD/CD was inserted or the required USB stor-
age device is connected and/or the network connection is up.
on the start page.
The menu Find patient is displayed.
► Finding patient data, see Menu Find patient.
► Select button Find patient
Fig. 40
Name
Enter new surgeon or operation and press the button
Up/Down
.
Select "surgeon" or "operation" and move it to the
intended position by pressing button
Deleting
or
.
Select “surgeon” or “operation” and delete the
selected entry by pressing button
.
Effective
21
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
4.8
Menu Find patient
No patient selected
If no patient was selected, the menus “Live image” and “Data overview”
cannot be called up.
4.9
Recording still images, video sequences and sound
► Create or select a patient via the button New patient
or Find
patient
on the start page.
The patient data of the selected patient is displayed.
Other buttons are displayed in the navigation bar.
► Select Live image button
.
The menu Live image is displayed.
► Use the menu Live image for recording single still images, video
sequences and sound as described below, see Menu Live image.
Fig. 41
Select the data medium to be searched, on which the patient data is
stored:
■ HD = Hard Drive
■ DVD = DVD or CD (DVD/CD must be in the DVD/CD drive)
■ USB = USB external storage device (USB storage device must be connected)
The following registers are available only if they have been configured
accordingly in the Settings/Network menu:
■ LAN = Network NetBEUI protocol
■ PACS = Network DICOM protocol (DICOM Upgrade Kit with Aesculap
PV842)
■ WL = Work list
Search for
Position the cursor in the selected input field.
Name
ID
Enter complete name or ID.
- or Start entering letters or numbers. Patients found
matching the entered data are displayed in the
selection list.
Date
Enter time interval from – to and press button
Start page
Switch to the start page.
Get worklist
Retrieve a DICOM work list through the network.
(Only with DICOM Upgrade Kit with Aesculap
PV842)
Live image
Select the "live Image" from the menu for the
selected patient (This function is only active if one
individual patient was selected in the patient list to
the right.
Data overview
Call up the menu “Data overview” for one patient or
several patients selected.
The menu "Data overview for one patient" or "Data
overview for several patients" is displayed.
Note
Still images and video sequences can also be recorded using the remote
control button on the camera head, see Connecting the camera control
unit, with a remote control cable connected and configured appropriately.
Video sequences can also be recorded using START/STOP button 3 on the
Eddy Full HD.
The video recording is automatically stopped when the capacity of the
HDD/DVD/LAN is reached. Before the end of the recording time a message
appears "Rest time 15 min/10 min/5 min/3 min/ 2 min/ 1min". When the
recording time is over, the message “Stopped recording“ is displayed.
The video recording will start automatically once the maximum file size of
a DVD is reached.
Effective
22
Document No.: TA022350 - Version: 1.0 - Document ID: SOP-AIC-5001120 Date/Time Printed/Viewed: 09/19/2012 18:10 (CET)
Effective
4.10 Menu Live image
Displaying and hiding elements
Fig. 42
Fig. 43
Note
Direct (live) storage is only possible on DVD-RAM media. This data cannot
be changed during recording. Changing different types of storage media is
not possible during the recording of a video sequence.
Note
Recordings on the DVD-RAM should be conducted in low or medium quality, as higher quality leads to data loss.
Storage location
Start video
Selection of the medium on which the data is to be
saved:
HDD = local hard disk
DVD = DVD-RAM, DVD±R, DVD±RW, DVD±R DL
USB = USB-storage device
LAN = remote memory (NetBEUI)
The storage capacity of the storage device used is
indicated by a bar on the right side of the display.
Start recording of a video sequence.
The button color changes to red.
The button text changes to “Stop video”.
The Video START/STOP-LED 4 at the Eddy Full HD is
on.
Stop video
Stop recording of a video sequence.
The button color changes back to white.
The button text changes to “Start video”.
The Video START/STOP-LED 4 at the Eddy Full HD is
on.
Image
Save image. The live image stream is interrupted and
the recorded still image is displayed for approx. 3 s.
Data overview
Switch to the start page.
► Click the center of the image to hide the operation elements
► Click the center of the image to redisplay the operation elements.
Managing image data and changing patient data
Managing recorded image data
Recorded images are cached by Eddy Full HD and can be viewed, selected
or deleted in menu “Data overview” prior to saving on DVD/CD or USB
storage device or through the network.
Note
Still images and video sequences cannot be edited on the Eddy Full HD.
Note
Saving to the network is only possible if the network connection is up and
the system administrator has released a network drive for sharing, see
Switching on Eddy Full HD and configuring the software.
Write DVD/USB is only possible if a writable DVD or CD has been inserted
or a USB storage device connected and if there is sufficient free storage
space on the respective media/device.
Changing patient data
The data which was entered via the “New patient” menu can be changed
in the menu “Data overview/Change patient data”.
Effective
23
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
4.11 Menu Data overview
Menu data overview (for one patient)
► Call up the patient data via the menu Find patient and switch to menu
Data overview
in the navigation bar by activating the button Data
overview.
- or ► Switch directly from menu Live image to menu Data overview, using
button Data overview
.
An overview of the data of the selected patient and the available preview images are displayed.
Other buttons are displayed in the navigation bar.
► View data, save or delete, see Menu Data overview (for several
patients).
CAUTION
Unrecoverable deleted patient data, still images
and/or video sequences!
► Before clicking on the appropriate “Delete”
icon, save data that are still required to a DVD/
CD, a USB storage device or to the network.
Menu Data overview (for several patients)
Fig. 45
Changing
patient data
Switch to sub menu Change patient data by clicking on the patient data and change data as required.
(The ID number can not be changed or deleted.)
Click the Save button after changing.
Images (Z)/
Videos (Z)
(tabs)
Overview of all still images/video sequences that
have been recorded for the selected patient. The figure in brackets (Z) represents the number of recordings.
Select Images in
the Images (Z)
tab
Select one or several images by clicking on them in
the overview. The selected images will be displayed
in blue frames. To deselect, click again on the framed
image.
Select Videos in
the Videos (Z)
tab
Click on a video in the overview. (if two videos are
selected at the same time, playback is not possible,
the symbol "playback" is gray.
Comments
Adding a comment to the selected image.
If two images are selected at the same time, no comment can be added the Comment is gray.
All/none
Select or deselect still images/video sequences.
Fig. 44
Data overview
In Data overview, individual patients can be
selected.
The active storage medium is displayed in the
header:
■
■
■
■
Navigation bar
Hard disk
DVD/CD
USB
Network
The buttons in the navigation bar allow copying of
patient data to DVD/CD, USB or network, as well as
printing or deleting of the data.
Note
The patient data fields above are left empty in this overview display.
Effective
24
Document No.: TA022350 - Version: 1.0 - Document ID: SOP-AIC-5001120 Date/Time Printed/Viewed: 09/19/2012 18:10 (CET)
Effective
4.12 Menu Change patient data
4.13 Menu Data overview/View image
Fig. 46
Fig. 47
Look at the
Images (Z) tab
The selected image is displayed in a larger scale.
Playback in the
Images (Z) tab
The selected video is played.
Delete image(s) in
the Image(s) (Z)
tab
Delete the
video(s) in the
Videos (Z) tab
All images/videos in blue frames selected in the
overview will be deleted.
Save on network
All data or the selected images and videos of the
present patient are saved to the network.
Printing a report
Print selected images as a report.
Write DVD/USB
All data or the selected images and videos of the
present patient are saved to DVD/CD or an external
USB storage device.
Delete patient(s)
The entire data set of the selected patient, including all associated still images and video sequences,
is deleted.
Start page
Switch to the start page.
Full image
To display Full-screen image (“Full image”): Click
on image.
Back to overview display: Click on the image again.
Previous picture
Jump to next image if several images have been
selected.
Next picture
Jump to next image if several images have been
selected.
Comment
Add comment to image.
Delete image
Delete image irrevocably.
Close
Close individual image display and switch to “Data
overview” menu.
View single image (after clicking on View on tab Images (Z)):
Effective
25
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
4.14 Menu Data overview/Comment
4.15 Menu Data overview/Video replay
Fig. 48
Fig. 49
Comment
Select an image from the overview by clicking on
it. Up to two line comments (recommended for
printing) are available for each image. Date and
time of recording are displayed under the image.
Full image
To display Full-screen video (“Full image”): Click on
video. Back to overview display: Click on video
again.
Progress bar
To forward or rewind the video to any position:
Move cursor. Date and start time of the video
recording are displayed in the lower left corner of
the screen. The actual position on, and the total
running time of the video are displayed in the
lower right corner.
Rewind
Rewind the video sequence to start of video.
Play
Start the video sequence.
Stop
Stop video sequence.
Image
Still image from present video is transferred to
“Data overview/Images” menu.
Delete video
Delete video sequence irrevocably.
Closing
Close video display and switch to “Data overview”
menu.
Play video sequence (after clicking on Replay on tab Videos (Z)):
Effective
26
Document No.: TA022350 - Version: 1.0 - Document ID: SOP-AIC-5001120 Date/Time Printed/Viewed: 09/19/2012 18:10 (CET)
Effective
4.16 Writing data to DVD/CD or USB storage device
CAUTION
The following choice is prompted when saving data to a USB storage
device:
Risk of data loss on the USB storage device!
► Deactivate the USB storage device before
removing the USB storage device.
Note
The USB storage device is deactivated automatically when shutting down
the Eddy Full HD.
All data or the selected images and videos of the present patient are saved
to DVD/CD or an external USB storage device.
► Click on Write DVD/USB in the Data overview screen.
A pop-up menu is displayed, see Fig. 50.
Fig. 51
Yes
The USB device will be disabled after data storage
and can then be removed.
No
The USB device will remain active for saving other
data.
Other prompts
Fig. 50
The following options can be selected:
Target drive:
■ DVD or CD
■ USB storage device
(Options are only active if a DVD/CD is in the drive or a USB storage device
is connected.)
Images and videos:
■ Selected data (selected images and videos)
■ All
Data saving is started by pressing the Write DVD/USB button.
The USB device can be deactivated without data saving by pressing the
Deactivate USB device button.
Fig. 52
Copy complete. Delete data?
Query displayed when data have been saved successfully on the network
drive or on a DVD/CD or USB storage device. Aesculap recommends deleting data on the (local) hard disk as soon as it is activated.
Fig. 53
Effective
27
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
Not enough free disk space
Information will be shown if there is not enough free disk space available
on the network drive or on the DVD/CD or USB storage device.
4.17 Data folder structure and file formats
Data are saved to DVD/CD, USB or network, in the following structure:
■ The folder name corresponds to the unique Patient ID.
■ The file "Root folder/EddyHD/Viewer" includes an image viewer software for patient data. The image analysis software consists of an executable file (AesCapHD_Viewer.exe), which allows easy viewing of the
contents of the folders on the PC with Windows XP and higher operating systems, see Eddy Full HD image viewing software.
■ The patient data is saved in an SQLite3 database in the file
"patient.SQLite3”.
■ The file names of the still images and video sequences are composed
as follows: "Record date/record time/record format"
■ Still images are stored in 2 formats:
– uncompressed Bitmap format (*.BMP)
– compressed JPG format (*.JPG)
■ Video sequences are stored in MPEG2 format (*.MPG).
Note
The file with the extension *.bmp.jpg or *jpg.jpg is used only as a preview
screen in the "Data overview".
The file with the extension *.mpg.jpg is only used for the preview display in
menu “Data overview”.
The following options can be selected:
Numbered reports:
■ 1, 2 or 3
Images:
■ Selected
■ All
► Select the required options.
► Click on Print preview.
The window with the print preview appears, see Fig. 55.
Fig. 55 A report with 3 images per page
► Select 3 images per page to generate a report with 3 images per page.
►
4.18 Printing a report
A report of the complete set of data and images for the selected patients
will be printed.
► Click on Print report in the Data overview screen.
A pop-up menu is displayed see Fig. 54.
►
►
►
►
Fig. 54
(Note: on the first page the patient information contains only
2 images)
Select 4 images per page to generate a report with 4 images per page.
(Note: on the first page the patient information contains only
3 images)
Select 8 images per page to generate a report with 8 images per page.
(Note: on the first page the patient information contains only
6 images)
Click on Back or Forward to scroll back or forward by one page in the
report.
Click on Print report.
The print job is sent to the printer.
Effective
28
Document No.: TA022350 - Version: 1.0 - Document ID: SOP-AIC-5001120 Date/Time Printed/Viewed: 09/19/2012 18:10 (CET)
Effective
4.19 Operating the printer
4.21 Eddy Full HD image viewing software
► Follow the manufacturer’s instructions for use.
Note
The Image Viewer software may only be used for documentation purposes.
The documented images are not approved for use in diagnosis and/or therapy!
Eddy Full HD writes on any DVD, CD, or any USB storage medium, Eddy
HD\viewer file, this includes picture viewer software for patient information. The image analysis software consists of an executable file
(AesCapHD_Viewer.exe), which allows easy viewing of the contents of the
folders on the PC with Windows XP and higher operating systems.
► Open the file AesCapHD_Viewer.exe by double-clicking on the respective DVD, CD or USB storage medium.
The home page appears, see Fig. 56.
4.20 Turning off Eddy Full HD
CAUTION
Data loss and software instability!
► Prior to switching off the Eddy Full HD, shut
down the software correctly, using the Exit button on the start page.
► Alternatively, press the Standby switch in the
front panel.
► Select “Exit” button on the start page.
- or ► Press the On/Standby switch in the front panel.
The software is shut down and the Eddy Full HD switches off automatically (Standby mode).
► Once the On/Standby LED 2 has gone dark, press ON/OFF switch 17 at
the Eddy Full HD or switch off at the master switch of the equipment
cart.
Fig. 56
ID number
Enter the ID number into the patient search.
Name
Enter the patient's last name into the patient
search.
First name
Enter the patient's first name into the patient
search.
Settings
Menu for setting the date format and language.
Data overview
Call up the “Data overview” menu for a selected
patient.
The menu Data overview for one patient or Data
overview for several patients is displayed.
Note
When you select a patient, the corresponding patient data appears in the
displayed Patient Data.
Effective
29
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
Menu Settings
Menu Data overview
Fig. 57
Fig. 58
Format of date
Select format of date:
- DD.MM.YYYY = European format
- MM/DD/YYYY = US format
DD=Day in two-digit numerical representation
MM=Month in two-digit numerical representation
YYYY=Year in four-digit numerical representation
Language
Select language:
German, English, French, Italian, Spanish, Czech
Version
Display the currently used software version of the
image analysis software.
Reject/
Patient search
Switch to patient search without saving.
Save/
Patient search
Save settings and switch to patient search.
Find patient
Switch to patient search.
The analysis functions of the image analysis software offers the same
functionality as the operating software of the Eddy Full HD (see Menu
data overview (for one patient)).
Any functions that allows data editing of the operating software of Eddy
Full HD are not supported by the image analysis software, i.e. saved data
may only be viewed.
Effective
30
Document No.: TA022350 - Version: 1.0 - Document ID: SOP-AIC-5001120 Date/Time Printed/Viewed: 09/19/2012 18:10 (CET)
Effective
5.
Validated reprocessing procedure
Note
Note the separate brochure for validated treatment preparation processes
(AVA-V6), see Validated cleaning and disinfection procedure.
5.1
Cleaning/disinfection
Product-specific safety instructions for the reprocessing procedure
DANGER
CAUTION
CAUTION
CAUTION
Risk of electric shock and fire hazard!
► Unplug the device before cleaning.
► Do not use flammable or explosive cleaning or
disinfecting solutions.
► Ensure that no fluids will penetrate the product.
Damage to, or destruction of the product caused by
mechanical cleaning/disinfection!
► Only clean and disinfect the product manually.
► Do not spray surface cleaning/disinfecting
agents into open sockets (e.g. USB sockets,
Video input and output sockets, mains power
socket) or into the DVD slot.
► Do not immerse or rinse the product in fluids
under any circumstances.
► Do not sterilize the product under any circumstances.
Damage to the product due to inappropriate cleaning/disinfecting agents!
► Only use cleaning/disinfecting agents approved
for surface cleaning. Follow the manufacturer’s
instructions for the respective cleaning/disinfecting agent.
Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures!
► Use cleaning agents and disinfectants according
to the manufacturer's instructions.
► Observe specifications regarding concentration,
temperature and exposure time.
Effective
31
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
Validated cleaning and disinfection procedure
Note
Reprocessing may only take place in accordance with the following listed
procedures in version V6. These are documented in the Validated Reprocessing Procedures brochure (AVA-V6). You can also find this brochure in
the Aesculap extranet at www.extranet.bbraun.com
Validated procedure
Special features
Wipe disinfection for
electrical devices without sterilization
5.2
Reference
Chapter Wipe
disinfection for
electrical devices
without sterilization
Inspection, maintenance and checks
► Inspect the product after each cleaning and disinfecting cycle to be
sure it is: clean, functional, and undamaged.
► Set aside the product if it is damaged.
6.
Maintenance
To ensure reliable operation, the product must be maintained at least once
a year.
For technical service, please contact your national B. Braun/Aesculap
agency, see Technical Service.
7.
Troubleshooting list
7.1
Notifications from Eddy Full HD
Message
Cause
Remedy
Failed to automatically print
Unexpected error occurred while caching
Repeat the process
Restart the system
Call Technical Service
Automatic printing failed
Unexpected error occurred while printing
Repeat the process
Restart the system
Call Technical Service
Burn process failed
General error during DVD/CD burning
Replace DVD/CD and restart disc burning procedure
If error persists: Call Technical Service
Calibration failed
Unexpected error during the calibration process
of the touch screen monitor
Repeat the process
Restart the system
Call Technical Service
Effective
32
Document No.: TA022350 - Version: 1.0 - Document ID: SOP-AIC-5001120 Date/Time Printed/Viewed: 09/19/2012 18:10 (CET)
Effective
Message
Cause
Remedy
Cannot be exported on the same medium
Attempting to export patient data to the same
storage medium
Select a different storage medium for export
Imaging failed
An unexpected error occurred during image
acquisition
Repeat the process
Restart the system
Call Technical Service
Copying process failed
Data could not be stored on DVD/USB/LAN.
Pull out and reinsert USB storage device
Check USB write protection
Test USB device function with a PC
Repeat process with a new DVD/CD
USB device could not be deactivated. Try again? USB device could not be deactivated
Repeat deactivating
DVD/CD read only
DVD/CD write operation failed
Replace DVD/CD
DVD/CD type is not supported
Disc not recognized as a DVD/CD
Check supported DVD/CD type
Check DVD/CD (for dirt, scratches, etc.)
Insert new disc in the DVD/CD drive
Patient profile system failed
An unexpected error occurred; patient profile
could not be created
Repeat the process
Restart the system
Call Technical Service
Failed to generate
Unexpected error occurred while generating
print preview
Repeat the process
Restart the system
Call Technical Service
ID number already exists
The ID number is already in use on the hard disk For the new patient a new ID number must be
entered
Importing failed. File "logo.jpg" or "logo.bmp"
not available in the root directory of your USB
device or DVD/CD
No storage device (USB/DVD/CD) or logo data
exist on USB/DVD/CD
Importing failed. Unsupported image format
Logo is too big or the wrong width/height ratio Convert logo in the appropriate format (width:
height should be 3)
Invalid date
An invalid date has been entered
Check and correct the date if necessary
Invalid date of birth
An invalid date of birth has been entered
Check and correct the birth date if necessary
Invalid time
An invalid time has been entered
Check and correct the time if necessary
Maximum number of images has been reached
Maximum number of captured images for this
patient has been reached, further acquisition of
images for this patient is not possible
Archive images on DVD/CD and delete data from
Eddy Full HD
Maximum number of videos has been reached
Maximum number of captured videos for this
patient has been reached, further acquisition of
videos for this patient is not possible
Archive videos on DVD/CD and delete data from
Eddy Full HD
Medium is read only
Write operation failed
Read check of the storage medium
Exchange storage medium
No DVD/CD in the drive, try again?
Insert/link storage device (USB/DVD/CD) with
the logo file "logo.jpg“ or „logo.bmp“
If a DVD/CD is inserted, wait until the DVD/CD is
detected
Try again
Insert new DVD/CD in the DVD/CD drive
Effective
No DVD/CD inserted
There is no disc in the DVD/CD-drive
Insert disc in the DVD/CD-drive
33
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
Message
Cause
Remedy
No video signal
Camera system is not connected or is turned off Check camera system
Call Technical Service
Not enough free disk space
The storage capacity of the target medium
(USB/DVD/LAN is insufficient for selected files
Passwords not identical
The repeat entry of the password was not iden- Repeat procedure: The second (confirming)
tical with the initial entry when the password
entry for the password must be the same as the
was changed
first entry
Please enter ID number
Blue input fields must be completely filled
(mandatory)
Fill out all mandatory fields
Please enter name
Blue input fields must be completely filled
(mandatory)
Fill out all mandatory fields
Recording failed
An unexpected error occurred during video
acquisition
Repeat the process
Restart the system
Call Technical Service
System authentication failed due to incorrect
serial number of the frame buffer
Improper frame grabber card detected
Call Technical Service
Initialization of the system core failed
An unexpected error occurred during system
start
Call Technical Service
USB device is not connected
Log data could not be copied to the USB device Reconnect the USB device (again)
Check USB write protection
Test USB device function with a PC
Video replay failure
Video was damaged (e.g. due to file system
error)
Write operation failed
Log data could not be copied to the USB device Repeat the process
Restart the system
Call Technical Service
Incorrect password
Incorrect password given
Use a storage medium with higher free capacity
Insert new disc in the DVD/CD-drive
Deselect video sequences or images if necessary
Call Technical Service
Repeat password entry
Call Technical Service
Effective
34
Document No.: TA022350 - Version: 1.0 - Document ID: SOP-AIC-5001120 Date/Time Printed/Viewed: 09/19/2012 18:10 (CET)
Effective
7.2
Network messages
Malfunction
Cause
Remedy
Backup failed
The data could not be backed up on the FTP
server
Check FTP server settings
Call the system administrator of the FTP server
Establishing general network settings failed
Wrong general IP settings for the network
adapter
Check entered IP addresses
Repeat the process
Restart the system
Call Technical Service
Invalid general network settings
Incorrect general IP settings
Check entered IP addresses
Call Technical Service
Login failed: Unknown user name or incorrect
password
Incorrect network name or wrong password in
the NetBEUI settings
Check NetBUI network settings
If error persists: Call network administrator
No connection
The appropriate network connection is not
available
Check general network settings
Check NetBUI network settings
Check FTP network settings
If error persists: Call network administrator
The network path was not found
The network drive in the NetBEUI settings was
not found
Check NetBEUI network settings
If error persists: Call network administrator
Malfunction
Cause
Remedy
No menu displayed
Monitor switched off
Switch on monitor; restart Eddy Full HD, if necessary, making certain that the monitor is
switched on during system start-up
Wrong channel setting for the video input signal
Make certain that the video input signal is set to
DVI.
Mains not connected correctly
Make certain that all cables are connected correctly
Driver problem
Call Technical Service
Camera switched off
Switch on camera; restart Eddy Full HD, if necessary, making certain that the monitor is
switched on during system run-up
Camera not connected correctly
Make certain that all cables are connected correctly
7.3
Other prompts
No live image
Test camera function through direct video connection between camera and monitor
Eddy Full HD not starting.
Mains cord not connected correctly
Check whether ON/Standby LED 2 is on
Make certain that the power cord is connected
correctly
Effective
35
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
Malfunction
Cause
Remedy
Touch-screen monitor does not work
Touch-screen cable not connected correctly
Make certain that the touch-screen cable is
connected correctly
Restart Eddy Full HD, if necessary, making certain that the touch-screen monitor is on during
system run-up
USB mouse does not work/
USB keyboard does not work
No obvious cause
Call Technical Service
Mouse/keyboard not connected correctly
Driver problem
Make certain that the mouse/keyboard is correctly connected at the USB socket
Restart Eddy Full HD with the mouse/keyboard
connected
Call Technical Service
Mouse/keyboard defective
Replace mouse/keyboard
Eddy Full HD not responding/does not respond
anymore
Hardware fault/driver problem/software error
Shut down and restart Eddy Full HD
Eddy Full HD has crashed/Eddy Full HD does not
recognize external devices
Overheating (especially in high ambient temperatures)
Switch off Eddy Full HD and let cool
Hardware fault/driver problem/software error
Shut down and restart Eddy Full HD
Call Technical Service if necessary
Make certain that there is enough space
between Eddy Full HD and other objects, especially at the rear of the unit
Call Technical Service and specify the error message, if applicable
Eddy Full HD does not save data to the network Network cable not connected correctly
Make certain that the network cable is connected correctly
Incorrect network settings
Have network settings checked by the system
administrator
No/insufficient privilege for access to network
Have network drive released for sharing by the
system administrator
IP address conflict
If possible, obtain IP address automatically
(DHCP, see software chapter in "settings"
menu")
Have network settings checked by the system
administrator
Eddy Full HD does not save data to DVD/CD
Eddy Full HD does not save settings
Storage space on DVD/CD used up
Replace DVD/CD
Wrong DVD/CD
Check DVD/CD (for supported DVDs/CDs see
Technical data)
Defective DVD/CD
Replace medium
Hardware fault
Call Technical Service
Hardware or software error
Call Technical Service
Effective
36
Document No.: TA022350 - Version: 1.0 - Document ID: SOP-AIC-5001120 Date/Time Printed/Viewed: 09/19/2012 18:10 (CET)
Effective
8.
Fuse replacement
9.
Technical Service
Risk of fatal injury from electric shock!
► Unplug the device before changing the fuses!
DANGER
Risk of injury and/or malfunction!
► Do not modify the product.
WARNING
► For service and repairs, please contact your national B. Braun/
Aesculapagency.
Modifications carried out on medical technical equipment may result in
loss of guarantee/warranty rights and forfeiture of applicable licenses.
Service addresses
►
►
►
►
Specified fuses: IEC 127, D 5 x 20 mm, T 1.0 A, breaking capacity L
(35A), 250V; art. no. TA021410
Use a small screwdriver to release the clip on the fuse holder 16.
Remove fuse holder 16.
Replace both fuses.
Reinsert fuse holder 16 so that it audibly snaps into place.
Note
If the fuses burn out frequently, the device is faulty and should be
repaired, see Technical Service.
Aesculap Technischer Service
Am Aesculap-Platz
78532 Tuttlingen / Germany
Phone:
+49 (7461) 95 -1601
Fax:
+49 (7461) 14 -939
E-Mail:
ats@aesculap.de
Or in the US:
Aesculap Inc.
Attn. Aesculap Technical Services
615 Lambert Pointe Drive
Hazelwood
MO, 63042 USA
Aesculap Repair Hotline
Phone:
+1 (800) 214 -3392
Fax:
+1 (314) 895 -4420
Other service addresses can be obtained from the address indicated above.
Effective
37
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
10. Accessories/Spare parts
Touch monitor
Art. no.
Designation
PV956
24" Full HD Monitor with touch function
Spare parts
Art. no.
Designation
PV920200
Optical mouse with USB connection
PV820201
DVI cable, 3m
TA021410
Lead fuse IEC 127, D 5 x 20 mm, T 1,0 A
DICOM Upgrade Set
Art. no.
Designation
PV842
DICOM 3.0 USB Set for EDDY Full HD
Cable
Art. no.
Designation
PV428
Serial connecting cable 9-pin sub-D, e.g. as touch
screen cable
PV967
Remote control cable, 1.7 m (cinch-jack)
PV968
Remote control cable, 2.0 m (cinch-jack)
11. Technical data
Classification acc. to Directive 93/42/EEC
Art.
no.
Designation
Class
PV840
Eddy Full HD digital documentation system
I
Network cable and special power cables
Art. no.
Designation
TE730
TE780
Germany, Denmark, France, Austria, Belgium,
Spain, Netherlands, Portugal, Luxembourg, Italy,
Sweden, Norway, Finland
Length 5 m
Length 1.5 m
TE734
United Kingdom, Ireland, 5 m
TE735
USA, Canada, Japan, 3.5 m
TE676
Special power cord IEC 320, 1 m
TE736
Special power cord IEC 320, 2,5 m
Note
For a complete overview of Aesculap Endoscopy equipment and accessories, see the Endoscopy Online Catalog at www.endoscopy-catalog.com
Effective
38
Document No.: TA022350 - Version: 1.0 - Document ID: SOP-AIC-5001120 Date/Time Printed/Viewed: 09/19/2012 18:10 (CET)
Effective
Mains voltage ranges
(Power consumption)
100-120 V~ (180 VA)/
220-240 V~ (180 VA)
Frequency
50-60 Hz
Display resolution
1920 x 1080 pixels
1280 x 720 pixels
Camera resolution
1080i 50/59.94/60Hz
720p 50/59.94/60Hz
System
2.5 GHz Intel® processor
2 GB RAM
Windows XP embedded
Installed on SSD hard drive
DVD/CD-drive (compatible media and
speeds)
DVD-RAM (Speed 5x)
DVD-R/+R (Speed 16x)
DVD-RW (Speed 6x)
DVD+RW (Speed 8x)
DVD-R Dual Layer (Speed 4x)
DVD+R Dual Layer (Speed 8x)
CD-R (Speed 16x)
Hard disk
500 GB
Network connection
Ethernet 10/100/1000 Mbit/s RJ45
Video inputs and out- HD SDI IN: BNC socket
puts
HD SDI OUT: BNC socket
DVI-D OUT
Interfaces
1 x Remote: 3.5 mm male plug
6 x USB 2.0
1 x RS232 9-pin sub-D plug
Video qualities (with
running times as
guide values)
High: corresponds to approximately 60 min/
DVD DL
Medium: corresponds to approximately
90 min/DVD DL
Low: corresponds to approximately 120 min/
DVD DL
Dimensions
(W) x (H) x (D)
305 mmx135 mmx305 mm
Weight
6.5 kg
Protection according
to EN60529
IP 20 D
Compliance
93/42/EWG, class Ι
Conforming to standard
EN 60601-1, protection class 1,
EN 60601-1-2
EN 62304
11.1 Ambient conditions
Operation
Storage and transport
Temperature
Relative
humidity
Atmospheric
pressure
12. Disposal
Note
The user institution is obliged to process the product before its disposal, see
Validated reprocessing procedure.
Adhere to national regulations when disposing of or recycling the product, its components and its packaging!
The recycling pass can be downloaded from the Extranet
as a PDF document under the respective article number.
(The recycling pass includes disassembling instructions for
the product, as well as information for proper disposal of
components harmful to the environment.)
Products carrying this symbol are subject to separate collection of electrical and electronic devices. Within the
European Union, disposal is taken care of by the manufacturer as a free-of-charge service.
► Detailed information concerning the disposal of the product is avail-
able through your national B. Braun/Aesculap agency, see Technical
Service.
13. Distributor in the US/Contact in Canada for product information and complaints
3773 Corporate Parkway
Center Valley, PA, 18034,
USA
Effective
39
Document No.: TA022350 - Version: 1.0 - Document ID: SOP-AIC-5001120 Date/Time Printed/Viewed: 09/19/2012 18:10 (CET)
Effective
- DIR 93/42/EEC
Aesculap AG | Am Aesculap-Platz | 78532 Tuttlingen | Germany
Phone +49 (0) 7461 95-0 | Fax +49 (0) 7461 95-26 00 | www.aesculap.com
Aesculap – a B. Braun company
Technical alterations reserved
Effective
TA-Nr. 022350
07/12
V6
Document No.: TA022350 - Version: 1.0 - Document ID: SOP-AIC-5001120 Date/Time Printed/Viewed: 09/19/2012 18:10 (CET)
Document Control
B|BRAUN
&
Effective
Signature Page
Title: EDDY FULL HD DIGITAL DOCUMENTATION SYSTEM PV840 Initiator: Kasey ? Sheeran
This document is signed electronically in compliance with the B. Braun electronic signature policies and
procedures by following persons:
UserName: Kasey Sheeran (sheekaus)
Title: Document Control Admin
Date: Friday, 14 September 2012, 20:25 W. Europe Daylight Time
Meaning: Document signed as Author
================================================
UserName: Kathy Racosky (racokaus)
Title:
Date: Monday, 17 September 2012, 15:43 W. Europe Daylight Time
Meaning: Approve Document
================================================
UserName: Angela Olivier (olivanus)
Title:
Date: Tuesday, 18 September 2012, 22:16 W. Europe Daylight Time
Meaning: Approve Document
================================================
UserName: Kasey Sheeran (sheekaus)
Title: Document Control Admin
Date: Wednesday, 19 September 2012, 17:40 W. Europe Daylight Time
Meaning: Final Release of the Document
================================================
Effective
Document No.: TA022350 - Version: 1.0 - Document ID: SOP-AIC-5001120 Date/Time Printed/Viewed: 09/19/2012 18:10 (CET)