B. Braun Aesculap Endoscopic Technology Manual

Aesculap®
Aesculap Endoscopic Technology
Instructions for use/Technical description
Full HD 3CCD Camera system PV460/PV462/PV463
Gebrauchsanweisung/Technische Beschreibung
Full HD 3CCD Kamerasystem PV460/PV462/PV463
Mode d’emploi/Description technique
Système de caméra HD 3CCD PV460/PV462/PV463
Instrucciones de manejo/Descripción técnica
Sistema de cámara 3CCD Full HD PV460/PV462/PV463
Istruzioni per l’uso/Descrizione tecnica
Sistema di videocamera Full HD 3CCD PV460/PV462/PV463
Instruções de utilização/Descrição técnica
Sistema de câmara Full HD 3CCD PV460/PV462/PV463
Gebruiksaanwijzing/Technische beschrijving
Full HD 3CCD camerasysteem PV460/PV462/PV463
Bruksanvisning/Teknisk beskrivning
Komplett HD 3CCD Kamerasystem PV460/PV462/PV463
Инструкция по примению/Техническое описание
3-х чиповая видеосистема с разрешением Full HD PV460/PV462/
PV463
Návod k použití/Technický popis
Full HD 3CCD kamerový systém PV460/PV462/PV463
Instrukcja użytkowania/Opis techniczny
System kamer Full HD 3CCD PV460/PV462/PV463
Návod na použivanie/Technický opis
Kamerový systém Full HD 3CCD PV460/PV462/PV463
Kullanım Kılavuzu/Teknik açiklama
Full HD 3CCD Kamera sistemi PV460/PV462/PV463

2
Aesculap®
Full HD 3CCD Camera system PV460/PV462/PV463
Aesculap® Full HD 3CCD Camera syste m PV460/PV462/PV463
Legend
1Locking device (for the endoscope eyepiece)
2Focusing ring
3Gray pushbutton
4Blue pushbutton
5Camera cable
6Camera head
7Zoom ring (only for PV462)
8Anti-rotation lock
9Camera plug
10 Camera control unit
11 ON/OFF LED
12 Backlit LCD (2 line x 20 column)
13 Pushbutton (for access to menus)
14 Pushbutton (for navigating menus)
15 Pushbutton (for selection from menus)
16 Pushbutton (for automatic white balance)
17 Camera socket
18 Pushbutton (for navigating menus)
19 Pushbutton (ON/STANDBY)
20 RS485 connector output
21 S-VIDEO output (standard definition)
22 HD-SDI video output 1 (High Definition)
23 DVI-D video output 1 (High Definition)
24 ON/OFF switch
25 Mains connection
26 Equipotentialization connector
27 DVI-.D video output 2 (High Definition)
28 HD-SDI video output 2 (High Definition)
29 LED Light Source connector output
30 Mono jack for remote control (3.5 mm)
Symbols on product and packages
Caution, general warning symbol
Caution, see documentation supplied with the product
Follow the instructions for use
Equipotentialization connector
Fuse
Type CF applied part
Power ON/STANDBY
Pushbutton for automatic white balance
Pushbutton for “up” in camera menus
Pushbutton for “down” in camera menus
Menu
Select item in camera menu
Marking of electric and electronic devices according to
directive 2002/96/EC (WEEE), see Disposal
Catalogue number
Serial number
Manufaturer
Date of manufacture
Identification in conformity with medical devices directive
93/42/EEC only valid if the product and/or packaging is
marked with this symbol.
Trademark of Intertek Testing Services NA, Inc., a nation-
ally Recognized Testing Laboratory, listing compliance as
Medical Electrical Equipment to standard UL 60601 and
CAN/CSA C 22.2 No. 601.1
Atmospheric pressure limitation
Humidity limitation
Temperature limitation
Fragile
Keep dry

3
Contents
1. Applicable to 3
2. Safe handling 3
2.1 Power Connection 4
3. Product description 4
3.1 System components 4
3.2 Components necessary for use 4
3.3 Intended use 4
3.4 Contraindications 4
3.5 Operating principle 4
4. Preparation and setup 4
4.1 Connecting the accessories 5
4.2 Setting the correct voltage 5
4.3 Connecting the power supply 5
4.4 Connecting the video cable 5
5. Working with the Full HD camera 5
5.1 System set-up 5
5.2 Function checks 5
5.3 Safe operation 6
6. Validated reprocessing procedure 9
6.1 General safety instructions 9
6.2 General information 10
6.3 Preparations at the place of use 10
6.4 Preparing the device 10
6.5 Preparation before cleaning 10
6.6 Cleaning/disinfection 10
6.7 Wipe disinfection for electrical devices without sterilization 11
6.8 Manual cleaning/disinfecting 12
6.9 Inspection, maintenance and checks 13
6.10 Packaging 13
6.11 Sterilization method and parameters 13
6.12 Storage 13
7. Functional test, maintenance and safety checks 13
7.1 Functional test at installation 13
7.2 Maintenance 14
7.3 Safety checks 14
8. Troubleshooting list 15
8.1 Fuse replacement 16
8.2 Changing power cord 16
9. Technical Service 16
10. Accessories/Spare parts 16
11. Technical data 17
11.1 Ambient conditions 17
12. Disposal 17
13. Distributor in the US/Contact in Canada for product
information and complaints 17
1. Applicable to
►For item-specific instructions for use and information on material
compatibility, see also the Aesculap Extranet at
www.extranet.bbraun.com
2. Safe handling
CAUTION
Federal law restricts this device to sale by, or on order of a physician!
►Remove the transport packaging and clean the new product, either
manually or mechanically, prior to its initial sterilization.
►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
not to compromise warranty and manufacturer liability:
– Use the product only according to these instructions for use.
– Follow the safety and maintenance instructions.
– Only combine Aesculap products with each other.
– Follow the application advisories acc. to standard, see Extracts from
relevant standards.
►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.
DANGER
Risk of fatal injury from electric shock!
►Do not open the product.
►Connect the product only to a grounded power
supply.
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.
WARNING
Risk of injury caused by explosion!
►Do not operate the product in the vicinity of
flammable anesthetics.
►Check the power cord for leakage currents and
correct grounding at regular intervals.

4
Aesculap®
Full HD 3CCD Camera system PV460/PV462/PV463
2.1 Power Connection
►Position equipment so that it is easy to remove power cord.
►Use a proper power cord for your local mains supply.
►Use the approved Power Cord (3-core mains lead)/Appliance Connec-
tor/Plug with earthing-contacts that conform to the safety regulations
of each country if applicable.
►Use the Power Cord (3-core mains lead)/Appliance Connector/Plug
conforming to the proper rating (Voltage, Ampere).
If you have questions on the use of the above Power Cord/Appliance
Connector/Plug, please contact qualified service personnel.
3. Product description
3.1 System components
Full HD 3CCD camera system PV460, consisting of:
■Full HD camera control unit
■Full HD 3CCD camera head, two versions available:
– Zoom camera head PV462 (to be ordered separately)
– Fixed focus camera head PV463 (to be ordered separately)
■DVI-D cable
■Instructions for use
3.2 Components necessary for use
In addition to the camera system, the following components are required
for an endoscopic intervention:
■Power cord
■Endoscope
■Light source
■Light cable
■Monitor
3.3 Intended use
The Aesculap Full HD camera (HD = High Definition) is an endoscopic
video camera for the transmission of real-time video images from a rigid
or flexible endoscope to a video monitor or other documentation equip-
ment.
The Aesculap Full HD camera can be used for any endoscopic application.
For their present applications, the camera includes a lens (zoom of fixed
focus) fitted with an endocoupler. An endoscope with standard eyepiece
is then connected to the endocoupler and held in place by the holding
mechanism of the endocoupler.
With its superior image quality of 1920 x 1080 pixels and progressive scan
mode, the Full HD camera is the preferred camera for endoscopic proce-
dures.
3.4 Contraindications
Operating surgeons who are not trained and qualified to perform endo-
scopic or laparoscopic surgery should not use this device.
3.5 Operating principle
The endoscope visualizes the operation area and the lens focuses this
image onto the three CCD sensors, where it is converted into digital sig-
nals. The image brightness is automatically adjusted according to the light
intensity (autoshutter).
Through camera cable 5, the digital image signals are transferred to cam-
era control unit 10, where the digital data are processed for display on the
monitor.
The video signal processed in this way can be picked up at the video output
monitor and by digital documentation devices.
The camera system features automatic, electronic brightening for areas
that are particularly difficult to illuminate. It offers six programmed
modes and three user modes for various surgical situations.
The video camera system is also equipped with an automatic white adjust-
ment system for optimal color representation.
The lens zoom function (PV462 camera head only) allows displaying the
image on the monitor with optimal enlargement.
4. Preparation and setup
Non-compliance with the following instructions will result in complete
exclusion of any responsibility and liability on the part of Aesculap.
►When setting up and operating the product, always observe the follow-
ing:
– national regulations for installation and operation
– national regulations on fire and explosion protection
DANGER
Risk of fatal injury from electric shock!
►Routinely examine the power cord and plug. Do
not use if inspection reveals damage.
►Replace only with approved hospital grade
power cord and plug with appropriate electrical
rating.

5
4.1 Connecting the accessories
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 perfor-
mance and safety characteristics of the products.
All devices 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 meet the system standard IEC/DIN EN 60601-1-1.
The person connecting the units is responsible for the configuration and
must ensure compliance with system standard IEC/DIN EN 60601-1-1 or
equivalent national standards.
►If you have any questions about that, contact your Aesculap partner or
Aesculap customer service.
4.2 Setting the correct voltage
The mains voltage must correspond to the voltage indicated on the unit
back panel.
4.3 Connecting the power supply
►Plug in the power cord at the mains connection 25 of the camera con-
trol unit 10.
►Connect the mains plug of the power cord to the building mains.
►Plug in the equipotentialization cable at the equipotentialization
connector 26 of the camera control unit.
►Connect the plug of the equipotentialization cable to the building
mains equipotentialization connector.
►To disconnect the camera from the mains, pull out the power cord from
the mains connection 25.
4.4 Connecting the video cable
►Connect the video cable at the camera back panel and the monitor or
the documentation system etc. Depending on the choice of the monitor
and documentation system, use the following camera outputs:
HD Monitor (High Definition):
■DVI-D for digital HD 1080p quality (recommended)
–or-
■HD-SDI for digital HD 1080i quality
–or-
■S-Video for analog SD quality
5. Working with the Full HD camera
5.1 System set-up
►Position the camera as close as possible to the patient so that the cam-
era cable length of 4 m can be fully utilized.
►Connect camera plug 9to camera socket 17 at the front panel of cam-
era control unit 10.
5.2 Function checks
►Check camera control unit 10 and camera head 6for external damage
and signs of knocks or other violent dents.
►Check that camera cable 5is not broken, kinked or twisted.
►To switch on the camera system, press pushbutton 19.
The current camera settings are displayed on the monitor:
AESCULAP Full HD 3 Chip Camera
MODE (current mode)
PERFORM WHITE BALANCE
►Make certain the front window of the camera head 6is absolutely
clean. If necessary, clean the window with isopropyl alcohol (70 %).
►If applicable, check that the zoom adjusting ring turns without resis-
tance.
►Make certain that focusing ring turns freely without sticking.
►Align camera head 6to an object in the room, focus the image and
check for good image quality.
►To finish using the Full HD camera system, press pushbutton 19.
WARNING
Risk of injury and/or product malfunctions due to
incorrect operation of the medical electric system!
►Adhere to the instructions for use of any medi-
cal device.
WARNING
Risk of electric shock!
►Only connect the equipment to a mains supply
with protective earth.
WARNING
Risk of injury and/or malfunctions!
►Carry out function checks before every use.

6
Aesculap®
Full HD 3CCD Camera system PV460/PV462/PV463
5.3 Safe operation
Connecting an endoscope with a sterile drape
►Verify that locking slide on the endocoupler is opened (unlock posi-
tion).
►Press and hold pushplate.
►Insert the sterile endoscope with the sterile camera drape and release
pushplate.
►To secure the endoscope against rotation, close locking slide (lock posi-
tion).
►Cover the camera head and the camera cable with the sterile camera
drape fastened to the sterile endoscope.
Note
Endocoupler can be positioned as required. To do this, swivel endocoupler
clockwise to the required position!
Performing automatic white balance
Upon insertion of the camera plug 9into the camera socket 17, the fol-
lowing message will appear on the monitor as a reminder to perform white
balance:
AESCULAP Full HD 3 Chip Camera
MODE (current mode)
PERFORM WHITE BALANCE
This message only disappears on the monitor if a white balance is per-
formed.
Perform the white balance as follows:
►Attach endoscope connected to the light source via light cable to the
camera head.
►Switch on light source and put light level indicators in appropriate
position.
►Point the endoscope to a white object (e.g., a sterile swab) at a distance
of about 2 cm.
►Press pushbutton 16 at the control unit while keeping the endo-
scope pointing to the white object.
- or -
►Press gray push button 2on the camera head for longer than 2.5 s and
keep the endoscope pointed at the white object.
The following message appears on the camera display and on the mon-
itor:
WHITE BALANCE IN PROCESS
MODE (current mode)
►If the automatic white balance is performed properly, the following
message appears on the camera display and on the monitor:
WHITE BALANCE OK
MODE (current mode)
The white object will be displayed in pure white. This procedure ensures
the authentic representation of all colors.
►If the automatic white balance did not work properly, the following
message appears on the camera display and on the monitor:
WHITE BALANCE FAILED
MODE (current mode)
►In this case repeat the automatic white balance procedure.
Menu navigation
The User Interface functions are provided via Controller Front Panel But-
tons, camera head buttons, camera display and the monitor On-Screen-
Display (OSD). Navigation through the menu structure and selections are
performed with Up, Down and Select buttons.
►Press Up 14 or Down 18 to navigate to a menu item.
►Press Select button 15 to select a menu item.
Each time a list of selections is displayed, the current active item (e.g., pro-
cedure mode or language) is shown in blinking text.
Each time the OSD is in a state of showing a lower hierarchy menu, press-
ing the Menu button returns the system to the next higher hierarchy menu
screen.
Unless selection is explicitly made by pressing Select button 15 the OSD
will time out after 3.5 seconds and automatically select the blinking item.
Short System Menu (Camera Head unplugged)
With the camera head unplugged and the unit powered On, all video out-
puts display the color bar test pattern. In this state the short system menu
is available for setting parameters that do not require live video during
selection. An abbreviated version of this menu is also repeated on the LCD
display 12 for medical staff and service personnel to perform changes
when a monitor is not available. Menu button press activates the follow-
ing OSD menu:
MODE (blinking)
LANGUAGE
50/60 HZ
SHOW SOFTWARE VERSION
RESET FACTORY DEFAULTS
DANGER
Risk of injury due to improper configuration!
►Ensure that applied parts from other suppliers
of electromedical devices, or any accessories
used for endoscopic application in this configu-
ration, are of type BF or type CF.

7
Mode Setting
Upon selection of procedure mode from the short system menu the list of
available mode settings is displayed
LAPAROSCOPY
NEUROENDOSCOPY
ARTHROSCOPY
UROLOGY
HYSTEROSCOPY
FIBERSCOPE
USER 1
USER 2
USER 3
The current active mode type is shown in blinking text. Navigation to and
selection of procedural mode type is performed as described above, see
Menu navigation.
User 1, User 2 or User 3 custom mode types may be selected from the
Short System Menu. However, no adjustment to the custom mode settings
may be made at this point as the camera head is unplugged. For re-setting
User 1, User 2 and User 3 custom mode types, see Main Menu.
The selected mode is saved in non-volatile memory and restored on the
next power-on event.
Language Setting
Upon selection of Language from the short system menu the list of avail-
able languages is displayed
ENGLISH
DEUTSCH
FRANCAIS
ITALIANO
ESPANOL
The current active language is shown in blinking text. Navigation to and
selection of the language is performed as described above, see Menu nav-
igation.
The selected Language is saved in non-volatile memory and restored on
the next power-on event.
Show Software Version
Upon selection of Show Software Version from the Short System Menu the
current software version is displayed on the OSD screen.
Resetting Factory Defaults
Upon selection of Reset Factory Defaults from the Short System Menu the
factory default values for all parameters except Language, 50/60 Hz and
USER 1, 2, 3 settings get restored.
The OSD confirmation:
RESET FACTORY DEFAULTS OK
appears for approximately 5 seconds followd by the prompt:
AESCULAP Full HD 3 Chip Camera MODE LARPAROSCOPY
Main Menu
With the camera head plugged in and the unit powered On, all video out-
puts display the live video. The OSD displays the current procedure mode
and prompts to perform the White Balance. Upon successful completion
of the White Balance the system is ready to use. Pressing button Menu 13
at any time during live video activates the Main Menu:
MODE (Blinking)
BRIGHTNESS
ENHANCEMENT
IMAGE SIZE SMALL/LARGE
COLOR
PEAK/AVERAGE
SYSTEM CONFIGURATION
Mode Setting
The mode setting is described above, see Short System Menu (Camera
Head unplugged).
Custom Mode Setting
If any of the “User N” where N = 1, 2, or 3 entries is selected the OSD
appears as follows (positions of the asterisks display the current active
settings, and are shown below in arbitrary positions):
SETTINGS USER N
BRIGHTNESS -....*....+
ENHANCEMENT -....*....+
PEAK/AVERAGE -....*....+
COLOR -....*....+
IMAGE SIZE SMALL MEDIUM LARGE
FIBERSCOPE OFF ON
EXIT
Adjusting Custom Mode Setting
►The selected setting to be adjusted is shown in blinking text. Press the
UP button 14 or DOWN button 18 to select the item to be adjusted.
►Press the Select button 15 when the desired item to be adjusted is
active (blinking).
Brightness Setting
►Press the UP button 14 to move the cursor on the Brightness slider to
the right (increase) and DOWN button 18 to move the cursor to the
left (decrease).
►Observe the change of brightness in the live video. Press the Select
button 15 when the desired brightness level is attained. Pressing of the
Select button 15 will automatically activate the next line Enhance-
ment (blinks).
Enhancement Setting
►Press UP button 14 to move the cursor on the Enhancement slider to
the right (increase) and DOWN button 18 to move the cursor to the
left (decrease).

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Aesculap®
Full HD 3CCD Camera system PV460/PV462/PV463
►Observe the change of contour enhancement (contrast) in the live
video. Press Select button 15 when the desired enhancement level is
attained. Note that excessive enhancement may increase the noise or
graininess of the image. Pressing of Select button 15 will automati-
cally make the next line Scene Peak/Average active (blinking).
Peak/Average Setting
►Use the Peak/Average setting to minimize blooming or “hot spots” arti-
facts. Note that excessive decrease of Peak/Average may darken the
image. Use the setting cautiously decreasing it for applications having
highly reflective bright scenes (e.g. knee arthroscopy).
►Press UP button 14 to move the cursor on the Peak/Average slider to
the right (increase) and Down button 18 to move the cursor to the left
(decrease).
►Observe the change in the scene blooming and “hot spots”. Press Select
button 15 when the desired Peak/Average level is attained. Pressing
Select button 15 will automatically make the next line Color active
(blinking).
Color Setting
Increasing the Color setting enhances the color content of Red details.
►Press UP button 14 to move the cursor on the Color slider to the right
(increase) and Down button 18 to move the cursor to the left
(decrease).
►Observe the color change in live video. Press Select button 15 when
the desired color balance is attained. Pressing of Select button 15 will
automatically make the next line Image Size active (blinking).
Image Size Setting
The currently active Image Size setting is shown highlighted on the OSD.
►Use UP button 14 and DOWN button 18 to change the selection
according to the active image area that is created by the attached
endoscope.
►Press Select to activate the selection. Pressing of Select button 15 will
automatically make the next line Fiberscope active (blinking).
Fiberscope Setting
►Fiberscope setting is used for suppression of unwanted stripes (alias-
ing) and “chicken wire” patterns appearing in the image when fiber-
scopes are utilized.
►Use Up button 14 and Down button 18 to change the selection to ON
when using a Fiberscope as an input device for the camera.
►Press Select button 15 to automatically advance the active line to Exit.
Note
Changing the Fiberscope setting to ON automatically disables Enhance-
ment setting. Never enable Fiberscope setting when other types of endo-
scopes are used, otherwise resolution and contrast of the image will be
adversely affected.
Upon selection of EXIT in the User Settings menu the following OSD
prompt appears:
PRESS SELECT TO SAVE SETTINGS
OR MENU TO RETURN TO EDITING
After the editing is completed the OSD prompt appears as follows for
approximately 5 seconds:
USER N (N= 1, 2; 3 )
SETTINGS SAVED
The user menu settings are saved in non-volatile memory and restored on
the next power-ON event.
Setting of Brightness, Enhancement, Image Size and Color from Main
Menu
Brightness, Enhancement and Color sliders as well as Image Size options
may be accessed from the Main Menu, see Main Menu.
►Select the menu entry using Up 14, Down 18 and Select buttons 15 as
described above in Menu Navigation section.
►Adjust the parameter to the desired value using Up 14 and Down 18
buttons.
►Observe the change in the live video and press Select button 15 when
the desired adjustment level is attained.
Note
The selected values are saved in volatile memory and WILL NOT get restored
on the next power-ON event. The next power-ON will reset all of the above
parameters to their pre-set values for each procedural Mode.
System Configuration Settings
System Configuration sub-menu may be accessed from the Main Menu by
selecting System Configuration entry. The following OSD appears on the
screen:
SYSTEM CONFIGURATION
LANGUAGE (blinking)
50/60 HZ
SHOW SOFTWARE VERSION
RESET FACTORY DEFAULTS
BLACK BALANCE
Language Setting
The setting of the “Language” from the System Configuration Menu is per-
formed in the same manner as described above, see Short System Menu
(Camera Head unplugged).
The selected Language is saved in non-volatile memory and restored on
the next power-on event.

9
50/60 Hz Setting
►Select “50/60 Hz” entry from System Configuration menu.
50Hz and 60Hz selection options will appear on the screen. The active
selection is shown in blinking text.
The 50/60 Hz setting configures the output vertical refresh rate of the SDI
and DVI outputs.
The 50/60 Hz options are also applicable to the Standard Definition S-
VIDEO output port. When set to 50Hz, the output format will be PAL.
When set to 60Hz, the output video format will be NTSC.
►Select 50Hz or 60Hz according to your peripheral device’s specifica-
tions.
The selection is saved in non-volatile memory and restored on the next
power-ON event.
Software Version
Selection of Show Software Version from the System Configuration menu
will display the software version of the camera system. This information
may be necessary for servicing the product.
Resetting Factory Defaults
Selection of Reset Factory Default entry from System Configuration menu
will restore the factory default settings for all parameters except Lan-
guage, 50/60 HZ, and USER 1, 2, 3.
Black Balance
Black Balance function may only be performed by Aesculap service
department or authorized representative. This operation is protected by
Pass Code as its incorrect execution may permanently damage the Camera
Head.
Operating camera head pushbutton controls
For the convenience of the operator such functions as white balance,
brightness, remote activation of peripheral devices and Aesculap LED light
source may be accessed via camera head pushbutton controls.
►Prepare the automatic white balance as described above, see Perform-
ing automatic white balance.
►Press gray pushbutton 3on the camera head for longer than 2.5 s and
keep the endoscope pointed at the white object.
►Follow the OSD prompts, see Performing automatic white balance
Performing brightness adjustment by camera head pushbutton con-
trols
►Apply a short press of less than 2.0 s to gray pushbutton 2on the cam-
era head.
Camera brightness slider will display.
BRIGHTNESS ....*....+
►Press the gray pushbutton 3to move the cursor on the Brightness
slider to the right (increase) and blue pushbutton 4to move the cursor
to the left (decrease).
►Stop when the desired brightness has been achieved. The slider OSD
will time out in about 10 seconds.
Performing remote activation of peripheral devices by camera head
pushbutton controls
►For Remote 1 output apply a short press of less than 2.0 s to blue
pushbutton 4on the camera head. The remote output beeper will beep
once.
►For Remote 2 output apply a long press of greater than 2.0 s to blue
pushbutton 4on the camera head. The remote output beeper will beep
twice.
Activation of LED light source by camera head pushbutton controls
►Connect Aesculap LED light source to the camera control unit 10 via
Light Source connector output 29.
►Press both gray pushbutton 3and blue pushbutton 4at the same time
for less than 2.0 s.
The Aesculap LED light source will activate (turn ON) if initially OFF or
deactivate (turn OFF) if initially ON.
Adjusting light, focus and optical zoom
►Adjust the intensity of the light source until sufficient illumination is
achieved.
►To adjust the focus for a sharp image, turn focusing ring.
►To adjust the image enlargement (zoom factor), turn zoom adjusting
ring (PV462 camera head only).
Remote control of an external documentation system
To connect an external documentation system (e.g. Aesculap Eddy Full HD
or any other suitable documentation system) at the mono jack for remote
control 30 of a peripheral (REMOTE):
►Connect remote control cable PV968 between the camera and the doc-
umentation system.
►For remote control of the external documentation system, see Operat-
ing camera head pushbutton controls.
6. Validated reprocessing procedure
6.1 General safety instructions
Note
Adhere to national statutory regulations, national and international stan-
dards and directives, and local, clinical hygiene instructions for sterile pro-
cessing.
Note
For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possi-
ble variants of CJD, observe the relevant national regulations concerning
the reprocessing of products.
Note
Mechanical reprocessing should be favored over manual cleaning as it
gives better and more reliable results.

10
Aesculap®
Full HD 3CCD Camera system PV460/PV462/PV463
Note
Successful processing of this medical device can only be ensured if the pro-
cessing method is first validated. The operator/sterile processing techni-
cian is responsible for this.
The recommended chemistry was used for validation.
Note
If there is no final sterilization, then a virucidal disinfectant must be used.
Note
For the latest information on reprocessing and material compatibility see
also the Aesculap extranet at www.extranet.bbraun.com
The validated steam sterilization procedure was carried out in the Aesculap
sterile container system.
6.2 General information
Dried or affixed surgical residues can make cleaning more difficult or inef-
fective and lead to corrosion. Therefore the time interval between appli-
cation and processing should not exceed 6 h; also, neither fixating pre-
cleaning temperatures >45 °C nor fixating disinfecting agents (active
ingredient: aldehydes/alcohols) should be used.
Excessive measures of neutralizing agents or basic cleaners may result in
a chemical attack and/or to fading and the laser marking becoming
unreadable visually or by machine for stainless steel.
Residues containing chlorine or chlorides e.g. in surgical residues, medi-
cines, saline solutions and in the service water used for cleaning, disinfec-
tion and sterilization will cause corrosion damage (pitting, stress corro-
sion) and result in the destruction of stainless steel products. These must
be removed by rinsing thoroughly with demineralized water and then dry-
ing.
Additional drying, if necessary.
Only process chemicals that have been tested and approved (e.g. VAH or
FDA approval or CE mark) and which are compatible with the product’s
materials according to the chemical manufacturers’ recommendations
may be used for processing the product. All the chemical manufacturer's
application specifications must be strictly observed. Failure to do so can
result in the following problems:
■Optical changes of materials, e.g. fading or discoloration of titanium or
aluminum. For aluminum, the application/process solution only needs
to be of pH >8 to cause visible surface changes.
■Material damage such as corrosion, cracks, fracturing, premature aging
or swelling.
►Do not use metal cleaning brushes or other abrasives that would dam-
age the product surfaces and could cause corrosion.
►Further detailed advice on hygienically safe and material-/value-pre-
serving reprocessing can be found at www.a-k-i.org, link to Publica-
tions, Red Brochure – Proper maintenance of instruments.
6.3 Preparations at the place of use
►Remove any visible surgical residues to the extent possible with a
damp, lint-free cloth.
►Transport the dry product in a sealed waste container for cleaning and
disinfection within 6 hours.
6.4 Preparing the device
Camera head
►Reprocess the product immediately after use.
►Use suitable cleaning/disinfecting agents if the product is put away in
wet condition.
6.5 Preparation before cleaning
6.6 Cleaning/disinfection
Product-specific safety instructions for the reprocessing procedure
CAUTION
Damage to the product due to incorrect handling
during processing!
►Prior to processing, separate the camera head
from the camera control unit.
►Separately process the camera head and the
camera control unit.
DANGER
Risk of electric shock and fire hazard!
►Prior to cleaning, unplug the power plug.
►Do not use flammable or explosive cleaning or
disinfecting solutions.
►Make certain that no fluids will penetrate the
product.
CAUTION
Damage to, or destruction of the product caused by
mechanical cleaning/disinfecting!
►Only clean and disinfect the product manually.
CAUTION
Damage to the product due to inappropriate clean-
ing/disinfecting agents!
►Only use a cleaning/disinfecting agents
approved for surface cleaning. Follow the man-
ufacturer’s instructions for the respective
cleaning/disinfecting agent.

11
Validated cleaning and disinfection procedure
6.7 Wipe disinfection for electrical devices without sterilization
RT: Room temperature
Phase I
►Remove any visible residues with a disposable disinfectant wipe.
►Wipe all surfaces of the optically clean product with a fresh, disposable
disinfectant wipe.
►Observe the specified application time (1 min minimum).
CAUTION
Damage to the product due to inappropriate clean-
ing/disinfecting agents and/or excessive tempera-
tures!
►Use cleaning and disinfecting agents according
to the manufacturer’s instructions. The cleaning
and disinfecting agents must
–be approved for anodized aluminum, plastic,
and high-grade steel,
–not attack softeners (e.g. silicone).
►Observe specifications regarding concentration,
temperature and exposure time.
►Do not exceed the maximum allowable cleaning
temperature of 60 °C.
CAUTION
Damage to the camera control unit due to inappro-
priate cleaning/disinfecting processes!
►For cleaning and disinfecting the camera con-
trol unit, only apply wipe disinfection followed
by drying with a lint-free cloth.
Validated procedure Special features Reference
Wipe disinfection for
electrical devices with-
out sterilization
■Camera control unit
■When cleaning products with movable hinges, ensure that these are
in an open position and, if applicable, move the joint while cleaning.
Chapter Wipe disinfection for electrical devices
without sterilization
Manual cleaning with
immersion disinfection
■Camera head
■Suitable cleaning brush
■Disposable syringe 20 ml
■When cleaning products with movable hinges, ensure that these are
in an open position and, if applicable, move the joint while cleaning.
■Drying phase: Use a lint-free cloth or compressed air for medical pur-
poses
Chapter Manual cleaning/disinfecting and sub-
section:
■Chapter Manual cleaning with immersion
disinfection
Phase Step T
[°C/°F] t [min] Conc. [%] Water quality Chemical
IWipedisinfectionRT ≥1 - - Meliseptol HBV wipes 50 % Propan-1-ol

12
Aesculap®
Full HD 3CCD Camera system PV460/PV462/PV463
6.8 Manual cleaning/disinfecting
►Prior to manual disinfecting, allow water to drip off for a sufficient
length of time to prevent dilution of the disinfecting solution.
►After manual cleaning/disinfection, check visible surfaces visually for
residues.
►Repeat the cleaning/disinfection process if necessary.
Manual cleaning with immersion disinfection
D–W: Drinking water
FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least)
RT: Room temperature
*Recommended: BBraun Stabimed
►Note the information on appropriate cleaning brushes and disposable
syringes, see Validated cleaning and disinfection procedure.
Phase I
►Fully immerse the product in the cleaning/disinfectant for at least 15
min. Ensure that all accessible surfaces are moistened.
►Clean the product with a suitable cleaning brush in the solution until
all discernible residues have been removed from the surface.
►If applicable, brush through non-visible surfaces with an appropriate
cleaning brush for at least 1 min.
►Mobilize non-rigid components, such as set screws, links, etc. during
cleaning.
►Thoroughly rinse through these components with the cleaning disin-
fectant solution (at least five times), using a disposable syringe.
Phase II
►Rinse/flush the product thoroughly (all accessible surfaces) under run-
ning water.
►Mobilize non-rigid components, such as set screws, joints, etc. during
rinsing.
►Drain any remaining water fully.
Phase III
►Fully immerse the product in the disinfectant solution.
►Mobilize non-rigid components, such as set screws, joints, etc. during
rinsing.
►Rinse lumens at least 5 times at the beginning of the exposure time
using an appropriate disposable syringe. Ensure that all accessible sur-
faces are moistened.
Phase IV
►Rinse/flush the product thoroughly (all accessible surfaces).
►Mobilize non-rigid components, such as set screws, joints, etc. during
final rinse.
►Rinse lumens with an appropriate disposable syringe at least five times.
►Drain any remaining water fully.
Phase V
►Dry the product in the drying phase with suitable equipment (e.g. cloth,
compressed air), see Validated cleaning and disinfection procedure.
Phase Step T
[°C/°F] t [min] Conc. [%] Water quality Chemical
I Disinfecting cleaning RT (cold) >15 2 D–W Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
II Intermediate rinse RT (cold) 1 - D–W -
III Disinfection RT (cold) 15 2 D–W Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
IV Final rinse RT (cold) 1 - FD-W -
VDrying RT - - - -

13
6.9 Inspection, maintenance and checks
►Remove the moisture from the camera plug and check that the con-
tacts are dry.
►Allow the product to cool down to room temperature.
►Inspect the product after each cleaning and disinfecting cycle to be
sure it is: clean, functional, and undamaged.
6.10 Packaging
►Follow the instructions for use for the applied packaging and storage
systems (e.g. instructions for use TA009721 for Aesculap Eccos storage
system).
►Insert the product in its proper position in the Eccos holder, or put it
on a tray in such a way that the product is protected against damage.
Ensure that all cutting edges are protected.
►Pack trays appropriately for the sterilization process (e.g. in Aesculap
sterile containers).
►Ensure that the packaging will prevent a recontamination of the prod-
uct.
6.11 Sterilization method and parameters
Working with single-use sterile drapes
►Use appropriate Aesculap single-use sterile drapes. Follow the instruc-
tions for use of the sterile drapes.
Sterilization through the Sterrad® sterilization process 50, 100S, 200
Note
The Sterrad® sterilization process can cause cosmetic changes to the cam-
era head and cable. These changes however do not affect its functionality.
►Sterilize through the Sterrad® sterilization processes 50, 100S, 200 and
adhere to the following rule:
– Place the coupler Anti-Lock slider in the middle position to allow
steriliant penetration on both sides off cavity.
– Arrange the camera head cable in loose coils to allow good flow of
sterilant. Avoid tightly packed coils that may obstruct sterilant pen-
etration to the surface of the cable.
Follow the manufacturer’s advisories for use of the Sterrad® system.
Use of a biological indicator is recommended to confirm effective ster-
ilization.
6.12 Storage
►Store sterile products in germ-proof packaging, protected from dust, in
a dry, dark, temperature-controlled area.
7. Functional test, maintenance and
safety checks
7.1 Functional test at installation
Prior to putting the camera into service for the first time, the device and
its accessories should be visually inspected and tested for operability by a
camera technician or bio-technician. Visual inspection requires examining
the control unit and camera head case for cracks, verifying that all con-
nectors are properly fastened, checking for insulation damage to the
power cord and other accessory cables, and inspecting for wall plug and
equipment damage.
►Verify operation by turning on the camera and checking functionality
as outlined in the setup and before procedure begins section of this
manual.
CAUTION
Damage to the camera control unit by sterilization!
►Do not sterilize the camera control unit under
any circumstances.
►Clean the camera control unit by surface disin-
fection only.
CAUTION
Damage to the camera head or the optical zoom
coupler caused by inappropriate sterilization pro-
cesses!
►Never sterilize the camera head or the optical
zoom coupler with steam or in an autoclave.
►Do not carry out chemical sterilization.

14
Aesculap®
Full HD 3CCD Camera system PV460/PV462/PV463
7.2 Maintenance
To ensure reliable operation, the product must be maintained in accor-
dance with the maintenance label.
For technical service, please contact your national B. Braun/Aesculap
agency, see Technical Service.
Note
It is recommended that the user should test the camera for operability and
also visually inspect the camera and its accessories (e.g., power cord,
cables) prior to each use as outlined in the section above.
Note
In your inquiries or correspondence please always indicate the model and
serial number printed on the identification plate. Further documentation is
available from the manufacturer on request.
If there is insulation damage to the power cord or accessory cables or if
any of the wall or equipment plugs are damaged, please replace the part
and dispose as outlined in this manual, see Disposal.
7.3 Safety checks
Safety checks require a functional test and electrical safety tests once a
year. It is not necessary that technical and safety inspections are per-
formed by qualified personnel; however, technical and safety inspections
of the camera and its accessories must be performed by persons, who,
based on their training, knowledge, and practical experience, are capable
of adequately performing such inspections and who do not require
instructions with regards to technical and safety inspection.
Required electrical safety according to IEC/DIN EN 60601-1 clause
18 & 19 or IEC 62353
CAUTION
No modification of this equipment is allowed! This
product has no user serviceable parts.
►Do not modify this equipment without authori-
zation of the manufacturer.
►If any part of the control unit and camera head
are damaged, contact your representative.
►Do not remove the cover or attempt to do any
repairs yourself.
WARNING
Risk of injury and/or malfunctions!
►Don’t use the device if technical and safety
inspection reveals a defect which could harm
the patient, clinicians, or third parties.
►Don’t use the device until it has been properly
repaired
►Immediately notify your representative of these
defects.
Tests Requirements
Impedance between earth
connection and housing
≤0.1 Ω
Enclosure leakage current ≤0.1 mA
Earth leakage current ≤0.5 mA
Patient leakage current ≤0.1 mA
Patient auxiliary current D.C. ≤0.01 mA
Patient auxiliary current A.C. ≤0.1 mA

15
8. Troubleshooting list
Malfunction Cause Remedy
No image on the monitor Device not powered Verify that all units are connected to mains power
and switched on
Fuse blown Fuse in camera T 0.5 A L/250 V~ (TA020394)
Wrong video input activated If the monitor supports several channels: Make cer-
tain the monitor is switched to the channel that is
connected to the camera system
Video cable defective Replace video cable
Video cable not connected Connect video cable
Image too dark Camera cable not connected or defective Ensure that the camera head is connected to the
camera control unit and the camera plug is dry
Light cable not connected Verify that the light cable is connected at the light
source and the light cable input of the endoscope
Light cable defective Connect new light cable
Light source dimmed down Turn up the light source intensity
Endoscope optical system defective If the image is too dark even without the camera:
Use a different endoscope and have the defective
endoscope repaired by the manufacturer
Image fuzzy or poorly defined Object out of focus Turn the focus adjustment ring of the endo coupler
until there is a sharp image
Debris on the endoscope tip Clean tip with a sterile cloth and isopropyl alcohol
(70 %)
Moisture on the camera cable plug Dry plug with gauze before plugging it in at the
camera plug
Image fogged Contaminated or fogged endoscope Check that the front and rear windows of the endo-
scope and the front window of the endo coupler are
clean; if necessary, clean windows with isopropyl
alcohol (70 %)
Use Aesculap Anti Fog Solution JG910 on the distal
window of the endoscope
Noise or excessive grain in the picture Brightness enhancement function is active Increase intensity of the light source
Image too bright or glary Light metering not at its optimum setting Press MENU for mode setting and select the opti-
mum light metering mode
Color bar displayed on the monitor Camera cable not connected to the camera con-
trol unit
Connect camera cable at the camera control unit
Unrealistic color representation on the
monitor
Automatic white balance failed Start automatic white-adjustment
Monitor color setting misadjusted Reset to factory setting
Video cable defective Replace video cable

16
Aesculap®
Full HD 3CCD Camera system PV460/PV462/PV463
8.1 Fuse replacement
Specified fuses: T 0.5 A L/250 V~; art. no. TA020394
►Use a small screwdriver to release the clip on the fuse holder.
►Pull out the fuse holder.
►Replace both fuses.
►Reinsert the fuse holder in such a way that it audibly snaps into place.
Note
If the fuses burn out frequently, the device is faulty and should be
repaired, see Technical Service.
Fig. 1
8.2 Changing power cord
►Replace only with approved power chord, connector and plug with
appropriate electrical rating.
United States and Canada - if replacement is necessary use the following
specification.
Other - if replacement is necessary use the relevant electrical power for
local mains and indicated power rating on the equipment.
9. Technical Service
►For service and repairs, please contact your national B. Braun/Aesculap
agency.
Modifications carried out on medical technical equipment may result in
loss of guarantee/warranty rights and forfeiture of applicable licenses.
Service addresses
Repairs handling camera systems:
Aesculap FLEXIMED GmbH
Reparaturservice
Robert-Bosch-Str. 1
79211 Denzlingen / Germany
Phone: [phone]
Fax: [phone]
E-mail: [email protected]
Telephone hotline for help with electrical devices and device combina-
tions:
Phone: [phone]
Or in the US:
Aesculap Inc.
Attn. Aesculap Technical Services
615 Lambert Pointe Drive
Hazelwood
MO, 63042 USA
Aesculap Repair Hotline
Phone: [phone]
Fax: [phone]
Other service addresses can be obtained from the address indicated above.
10. Accessories/Spare parts
DANGER
Risk of fatal injury from electric shock!
►Unplug the device before changing the fuses!
Connector type: IEC 60320 C13
Plug type: Hospital Grade
Minimum rating for plug
and connector:
10 A/125 V
Cable type: Minimum SJT
Minimum 18 AWG
Safety: UL Listed and CSA
WARNING
Risk of injury and/or malfunction!
►Do not modify the product.
Art. no. Designation
PV462 Camera head, zoom
PV463 Camera head, fixed focus
TA020394 Fuse set T 0.5 A L/250 V~

17
11. Technical data
Classification acc. to Directive 93/42/EEC
11.1 Ambient conditions
12. Disposal
Note
The user institution is obliged to process the product before its disposal, see
Validated reprocessing procedure.
►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 Can-
ada for product information and com-
plaints
3773 Corporate Parkway
Center Valley, PA, 18034,
USA
Art. no. Designation Class
PV460/
PV462/
PV463
Full HD 3CCD Camera system I
Mains power 100–240 VAC, 50–60 Hz
Power consumption 65 VA
Image sensors 3 CCD sensors 1/3 Inch
Resolution 1920 x 1080 pixels
Video outputs:
DVI-D
HD-SDI
S-Video
1080p; 50 Hz or 60 Hz aspect ratio
16:9
1080i; 50 Hz or 60 Hz aspect ratio
16:9
PAL or NTSC
Water and dust protection Camera head: IPX7
Control unit: IP20
Dimensions, control unit
(W) x (H) x (D)
305 mm x 75 mm x 305 mm
Dimensions camera head
(without endocoupler)
(W) x (H) x (D)
40 mm x 53 mm x 72 mm
Applied part Type CF
EMC IEC/DIN EN 60601-1-2
Conforming to IEC/DIN EN 60601-1
Operation Storage and transport
Temperature
Relative
humidity
Atmospheric
pressure
Adhere to national regulations when disposing of or recy-
cling the product, its components and its packaging!
Products carrying this symbol are subject to separate col-
lection of electrical and electronic devices. Within the
European Union, disposal is taken care of by the manufac-
turer as a free-of-charge service.

18
Aesculap®
Full HD 3CCD Kamerasystem PV460/PV462/PV463
Aesculap® Full HD 3CC D Kamerasystem PV4 60/PV462/PV463
Legende
1Sperrvorrichtung (für das Okular des Endoskops)
2Einstellring für die Brennweite
3Grauer Druckknopf
4Blauer Druckknopf
5Kamerakabel
6Kamerakopf
7Zoomring (nur für PV462)
8Verdrehsicherung
9Kamera-Anschlussstecker
10 Kamerasteuereinheit
11 LED EIN/AUS
12 Hintergrundbeleuchtetes LCD (2 Zeilen x 20 Spalten)
13 Druckknopf (Zugriff auf Menüs)
14 Druckknopf (zur Navigation in Menüs)
15 Druckknopf (zum Auswählen aus Menüs)
16 Druckknopf (für automatischen Weißabgleich)
17 Kamerabuchse
18 Druckknopf (zur Navigation in Menüs)
19 Druckknopf (EIN/STANDBY)
20 RS485-Konnektorausgang
21 S-VIDEO-Ausgang (Standardauflösung)
22 HD-SDI-Videoausgang 1 (High Definition)
23 DVI-D-Videoausgang 1 (High Definition)
24 EIN/AUS-Schalter
25 Netzanschluss
26 Potentialausgleichsanschluss
27 DVI-D-Videoausgang 2 (High Definition)
28 HD-SDI-Videoausgang 2 (High Definition)
29 Anschluss LED-Lichtquelle
30 Monostecker für Fernbedienung (3,5 mm)
Symbole an Produkt und Verpackung
Achtung, allgemeines Warnzeichen
Achtung, Begleitdokumente beachten
Gebrauchsanweisung befolgen
Potentialausgleichsanschluss
Sicherung
Typ CF Anwendungsteil
Strom (EIN/STANDBY)
Druckknopf für automatischen Weißabgleich
Druckknopf „nach oben“ in Kameramenüs
Druckknopf „nach unten“ in Kameramenüs
Menü
Punkt in Kameramenü auswählen
Kennzeichnung elektrischer und elektronischer Geräte
gemäß Richtlinie 2002/96/EG (WEEE), siehe Entsorgung
Katalognummer
Seriennummer
Hersteller
Herstelldatum
Kennzeichnung in Übereinstimmung mit EU-Richtlinie 93/
42/EWG über Medizinprodukte nur gültig, wenn das Pro-
dukt und/oder die Verpackung mit diesem Symbol gekenn-
zeichnet ist.
Warenzeichen von Intertek Testing Services NA, Inc.,
einem national anerkannten Testlabor, das die Konformi-
tät als medizinisches elektrisches Gerät gemäß Standard
UL 60601 und CAN/CSA C 22.2 No. 601.1 anzeigt.
Luftdruckbegrenzung
Luftfeuchtigkeitsbegrenzung
Temperaturbeschränkung
Zerbrechlich
Vor Nässe schützen