Braun Aesculap PV442 Manual

Aesculap®
Aesculap Endoscopic Technology
Instructions for use/Technical description
Full HD 3CCD Camera system PV440
Gebrauchsanweisung/Technische Beschreibung
Full HD 3CCD Kamerasystem PV440
Mode d’emploi/Description technique
Full HD 3CCD Système de caméra PV440
Instrucciones de manejo/Descripción técnica
Full HD 3CCD Sistema de cámara PV440
Istruzioni per l’uso/Descrizione tecnica
Full HD 3CCD Sistema videocamera PV440
Instruções de utilização/Descrição técnica
Full HD 3CCD Sistema da câmara PV440
Gebruiksaanwijzing/Technische beschrijving
Full HD 3CCD Camerasysteem PV440
Bruksanvisning/Teknisk beskrivning
Full HD 3CCD Kamerasystem PV440
Инструкция по примению/Техническое описание
Full HD 3CCD Камера PV440
Návod k použití/Technický popis
Full HD 3CCD Kamerový systém PV440
Instrukcja użytkowania/Opis techniczny
Full HD 3CCD Układ kamery PV440
Návod na použivanie/Technický opis
Full HD 3CCD Kamerový systém PV440
Kullanım Kılavuzu/Teknik açiklama
Full HD 3CCD Kamera sistemi PV440
사용 설명서 /기술 설명
의료용카메라헤드 ( 형명개별기재 )

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Aesculap®
Full HD 3CCD Camera system PV440
Aesculap® Full HD 3CCD Camera system PV440
Legend
1Endo-lens (example image)
2Gray Push button
3Blue Push button
4Camera cable
5Camera head
6Camera plug
7Camera control unit
8ON/OFF LED
9Camera display
10 Push button (for mode setting)
11 Push button (for increasing brightness)
12 Push button (for automatic white balance)
13 Camera socket
14 Push button (for decreasing brightness)
15 Push button (ON/STANDBY)
16 Mono jack for remote control (3.5 mm)
17 DVI-D video output (High Definition)
18 50/60 Hz switch (serial number 2000 or higher)
19 RGB video output (High Definition)
20 S-VIDEO output (Standard Definition)
21 VIDEO output (Standard Definition)
22 HD-SDI video output 1 (High Definition)
23 HD-SDI video output 2 (High Definition)
24 ON/OFF switch
25 Mains power
26 Equipotentialization connection
Symbols on product and packages
Caution, general warning symbol
Caution, see documentation supplied with the prod-
uct
Follow the instructions for use
Marking of electric and electronic devices according
to directive 2002/96/EC (WEEE). see Disposal
Equipotentialization connection
Fuse
Type CF applied part
Power on/standby
Camera socket
Push button for automatic white balance or to set in
the camera menu
Brightness
Push button for mode selection or to close the cam-
era menu
Push button for increasing brightness or to move
"up" in the camera menu
Push button for decreasing brightness or to move
"down" in the camera menu
Low temperature and plasma sterilization

3
Contents
1. Applicable to 3
2. Safe handling 3
3. Product description 4
3.1 Scope of supply 4
3.2 Components required for operation 4
3.3 Intended use 4
3.4 Operating principle 4
4. Preparation and setup 4
4.1 First use 4
Connecting the accessories 5
Presetting the correct voltage 5
Mains power 5
Connecting the video cable 5
Screwing on the endo-lens 6
4.2 Settings 6
Access to main menu 6
Changing video formats 6
Changing the display language 6
Exit main menu 6
5. Working with the Full HD Camera 7
5.1 System set-up 7
5.2 Function checks 7
5.3 Safe operation 7
Connecting the endoscope and sterile cover 7
Performing white balance 7
Selecting the mode 7
Adjusting light, focus and optical zoom 8
Adjusting the digital zoom 8
Adjusting the brightness 8
Adjusting the user mode settings 8
Available parameters for user modes 9
Remote control of an external documentation system 9
6. Validated reprocessing procedure 9
6.1 General safety instructions 9
6.2 General information 9
6.3 Preparations at the place of use 10
6.4 Preparation before cleaning 10
6.5 Cleaning/disinfection 10
Product-specific safety instructions for the reprocessing
procedure 10
Validated cleaning and disinfection procedure 10
6.6 Wipe disinfection for electrical devices without sterilization 11
6.7 Manual cleaning/disinfecting 11
Manual cleaning with immersion disinfection 11
6.8 Inspection, maintenance and checks 12
6.9 Packaging 12
6.10 Sterilization 12
6.11 Storage 12
7. Maintenance 13
8. Troubleshooting list 13
8.1 Fuse replacement 14
9. Technical Service 14
10. Accessories/Spare parts 14
11. Technical data 15
11.1 Ambient conditions 15
12. Disposal 15
13. Distributor in the US/Contact in Canada for product
information and complaints 15
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.
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.
CAUTION
No camera image produced, due to combination of
incompatible components!
►Use the camera head PV442 with serial number
≥ SN3000 only with the camera control unit
PV440 with serial number ≥ SN2000.

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Aesculap®
Full HD 3CCD Camera system PV440
►To prevent damage caused by improper setup or operation, and in order
not to compromise warranty and manufacturer liability:
– Only use the product according to these instructions for use.
– Follow the safety and maintenance instructions.
– Only combine Aesculap products with each other.
►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.
►Do not operate the product in the vicinity of flammable anesthetics.
►Check the power cord for leakage currents and correct grounding at
regular intervals.
3. Product description
3.1 Scope of supply
Full HD 3CCD Camera system PV440, consisting of:
■Full HD camera control unit
■Full HD 3CCD Camera head
■DVI-D cable
■Instructions for use
3.2 Components required for operation
In addition to the camera system, the following components are required
for an endoscopic intervention:
■Endo-lens
■Power cord
■insert the endoscope
■Light source
■Light cable
■Monitor
3.3 Intended use
The Aesculap Full HD (=High Definition) camera is an endoscopic video
camera to transmit real-time video images of a rigid or flexible endoscope,
via the use of a lens with endocoupler, to a video monitor or other related
documentation devices.
The Aesculap Full HD camera is suitable for all endoscopic applications.
The current use of the camera involves connecting a lens with endocou-
pler to the camera. An endoscope with standard eyepiece is then con-
nected to the endocoupler and held in place by the grasping mechanism
of the endocoupler.
The Full HD camera is the preferred camera for endoscopic procedures due
to its superior image quality of 1920 x 1080 pixel and progressive scan
mode.
3.4 Operating principle
An endoscope visualizes the operation site and an objective lens focuses
this image onto the three CCD sensors, where it is converted into digital
signals. The image brightness is automatically adjusted according to the
light intensity (autoshutter).
Through camera cable 4, the digital image signals are transferred to cam-
era control unit 7, where the digital data are processed to be displayed on
the monitor.
The video signal processed in this way is then picked up at the video out-
put monitor, and digital documentation devices.
The camera system offers automatic, electronic brightness enhancement
for areas that are particularly difficult to illuminate, as well as five differ-
ent fixed mode settings and three user adjustable mode settings for vari-
ous situations during operation.
The video camera system is also equipped with a white adjustment system
for optimal color representation.
The lens and an additional electronic zoom feature ensures that the image
on the monitor is displayed at the optimum size.
4. Preparation and setup
Non-compliance with the following instructions will preclude all respon-
sibility and liability in this respect on the part of Aesculap.
►When setting up and operating the product, adhere to
– national regulations for installation and operation,
– national regulations on fire and explosion protection.
Note
For the safety of patients and users it is essential that the mains power cord
and, especially, the protective earth connection are intact. In many cases
defective or missing protective earth connections are not registered imme-
diately.
►Connect the device via the potential equalization terminal at the rear
panel of the device to the potential equalization system of the room
used for medical purposes.
Note
The potential equalization lead can be ordered from the manufacturer as
art. no. GK535 (4 m length) or TA008205 (0.8 m length).
4.1 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 medi-
cal device.

5
4.1.1 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.
Also note that any equipment connected at the interfaces must demon-
strably meet the respective IEC standards (e.g. IEC 60950 for data process-
ing 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.
4.1.2 Presetting the correct voltage
The mains voltage must correspond to the voltage indicated on the type
plate at the back of the unit.
4.1.3 Mains power
►Plug in the power cord at mains connection 25 of camera control
unit 7.
►Connect the mains plug of the power cord to the building mains.
►Plug in the equipotentialization cable at equipotentialization connec-
tor 26 of 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.
4.1.4 Connecting the video cable
►Connect the video cable to the camera rear panel and to the monitor,
documentation systems etc. Depending on the monitor and documen-
tation system use the following connections:
HD Monitor (High Definition):
■DVI-D for digital HD 1080p quality
- or -
■HD-SDI for digital HD 1080i/720p quality
- or -
■RGB-Sync for analog HD 1080i/720p quality
Fig. 1
Legend
1HD Monitor
2SD Monitor
3Full HD camera system
4Mains
5Equipotentialization
SD Monitor/SD documentation system (Standard Definition):
■S-Video for analog SD quality
- or -
■Video for analog SD quality
Fig. 2
Legend
1HD Monitor
2SD Monitor
3Full HD camera system
4Mains
5Equipotentialization
6e.g. Aesculap Eddy DVD
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.
WARNING
Risk of electric shock!
►Only connect the equipment to a supply mains
with protective earth.
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12
3
4
5
6

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Aesculap®
Full HD 3CCD Camera system PV440
4.1.5 Screwing on the endo-lens
Note
Different endo-lenses are available for the camera system.
►Follow instructions for use of the endo-lens.
►Screw endo-lens 1onto camera head 5.
4.2 Settings
4.2.1 Access to main menu
►Unplug the camera plug 6from the camera socket 13.
►Switch on camera control unit 7.
The following test chart appears on the monitor:
►Press and hold Push button 10 for 3 seconds.
The following message appears on the camera display:
4.2.2 Changing video formats
Note
If the aspect ratio is set to 4:3, the image is cut off on the left and right mar-
gins with SD video signals.
►Select the camera frequency 50 Hz or 60 Hz (serial number 2000 and
higher): Put 50/60 Hz switch 18 in the corresponding position, accord-
ing to your requirements.
►Press Push button 11 in the main menu to change the video format.
The following formats can be set:
* There is always a progressive scan signal on the DVI-D output.
4.2.3 Changing the display language
►Press Push button 14 to change the display language.
– English
–Deutsch
–Français
–Español
–Italiano
4.2.4 Exit main menu
►Press Push button 10 or plug in camera plug 6.
Camera setting Video outputs
Main menu 50/60 Hz
switch Aspect ratio 16:9 S-Video/Video
DVI-D* HD-SDI/
RGB
HD 1080i–
SD 16:9
50 Hz 1080p 50 1080i 50 576i PAL 16:9
HD 1080i–
SD 4:3
576i PAL 4:3
HD 720p–
SD 16:9
50 Hz 720p 50 720p 50 576i PAL 16:9
HD 720p–
SD 4:3
576i PAL 4:3
HD 1080i–
SD 16:9
60 Hz 1080p 60 1080i 60 480i NTSC 16:9
HD 1080i–
SD 4:3
480i NTSC 4:3
HD 720p–
SD 16:9
60 Hz 720p 60 720p 60 480i NTSC 16:9
HD 720p–
SD 4:3
480i NTSC 4:3

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5. Working with the Full HD Camera
5.1 System set-up
►Position the camera tower as close as possible to the patient so that
the camera cable length of 3 m can be fully utilized.
►Connect the camera plug 6to camera socket 13 at the front panel of
camera control unit 7. Take care that the marking UP on the camera
plug 6is pointing upwards.
5.2 Function checks
►Check camera control unit 7and the camera head 5for external dam-
age and signs of knocks or other violent impacts.
►Check that the camera cable 4is not broken, kinked or twisted.
►Press Push button 15 to power on the camera system.
The current settings of the camera appear on the monitor:
►Check to make certain that the front window of endo-lens 1is com-
pletely clean. If necessary, clean the window with isopropyl alcohol
(70 %).
►If necessary, ensure that the zoom adjustment ring turns freely without
resistance.
►Make certain that the focusing ring turns freely without resistance.
►Align camera head 5to an object in the room, focus the image and
check for good image quality.
►To terminate the operation of the Full HD camera system press the
Push button 15.
5.3 Safe operation
5.3.1 Connecting the endoscope and sterile cover
►Make certain that the locking slide is opened ("Unlock" position).
►Press and hold down lock.
►Insert sterile endoscope with sterile cover and release lock.
►To lock the endoscope against rotation, close the locking slide ("lock"
position).
►Cover the camera head and cable with the sterile cover fixed to the
sterile endoscope.
Note
The endocoupler can be positioned as required. To do this, swivel endocou-
pler to the required position!
5.3.2 Performing white balance
►Point endoscope to a white object (for example a sterile swab) at a dis-
tance of 2 cm.
►Press Push button 12 on the control unit and keep endoscope
pointed at the white object.
- or -
►Press gray Push button 2on the camera head for longer than 2.5 sec-
onds and keep endoscope pointed at the white object.
The following message appears on the camera display and on the mon-
itor:
►If the white balance is performed properly, the following message
appears on the camera display and on the monitor:
The image will be displayed in pure white. This procedure ensures the
accurate representation of all colors.
►If the white balance did not perform properly, the following message
appears on the camera display and on the monitor:
►In this case please repeat the white balance procedure.
5.3.3 Selecting the mode
To achieve the optimum image quality with endoscopes for different sur-
gical applications, the following modes can be selected:
■Laparoscopy Standard
■Laparoscopy Advanced
■Arthroscopy
■Hysteroscopy
■Neuroendoscopy
■User 1
■User 2
■User 3
WARNING
Risk of injury and/or malfunction!
►Always carry out a function check prior to using
the product.
DANGER
Risk of injury due to unapproved configuration!
►Make certain that application parts of other
electrical medical devices or accessories used in
this configuration for the endoscopic applica-
tion are of type BF or CF.

8
Aesculap®
Full HD 3CCD Camera system PV440
To change the mode on the camera control unit:
►Press Push button 10 on camera control unit once.
The current mode appears on the camera display and on the monitor:
►Press Push button 10 on camera control unit until the desired mode
is displayed.
After 3 seconds the setting displayed will disappear and the selected
mode is saved.
To change the mode on the camera head:
►Press both Push buttons on the camera head for longer than 3 seconds.
The current mode appears on the camera display and on the monitor:
►Press the blue Push button on the camera head to switch to previous
mode or press the gray Push button on the camera head to switch to
next mode.
After 3 seconds the setting displayed will disappear and the selected
mode is saved.
5.3.4 Adjusting light, focus and optical zoom
►Adjust the brightness of the light source until sufficient illumination is
achieved.
►To adjust the focus for a sharp image, turn focusing ring.
►To adjust the size of the image (zoom factor), turn the zoom adjust-
ment ring.
5.3.5 Adjusting the digital zoom
►Press both Push buttons on the camera head and release both after a
short time (2.5 seconds).
The following message appears on the camera display and on the mon-
itor:
The following digital zoom settings can be selected:
■Zoom switched off = ZOOM 1.0
■Zoom activated = ZOOM 1.1x /1.2x /1.3x /1.4x /1.5x/1.6x /1.7x /1.8x/
1.9x/2.0x
►To change the digital zoom setting, press one of the Push buttons on
the camera head as follows:
– press the blue Push button to decrease the digital zoom.
– press the gray Push button to increase the digital zoom. After 3 sec-
onds the setting displayed will disappear and the selected zoom
setting is saved.
5.3.6 Adjusting the brightness
To adjust the brightness on the camera control unit:
►Press Push button 11 on the camera control unit to increase the
brightness.
►Press Push button 14 on the camera control unit to decrease the
brightness.
The following message appears on the camera display and on the mon-
itor:
After 3 seconds the setting displayed will disappear and the selected
brightness setting is saved.
To adjust the brightness on camera head:
►Press gray Push button 2on the camera head and release after a short
time (2.5 seconds).
The following message appears on the camera display and on the mon-
itor:
►To change the brightness, press one of the Push buttons on the camera
head as follows:
– press the blue Push button 3to decrease the brightness.
– press the gray Push button 2to increase the brightness. After 3 sec-
onds the setting displayed will disappear and the selected bright-
ness setting is saved.
5.3.7 Adjusting the user mode settings
►Press Push button 10 on camera control unit 7and select USER 1,
USER 2 or USER 3 mode.
►Press and hold Push button 10 for 3 seconds.
The following message appears on the monitor:
►Press Push button 11 or 14 to select the desired parameter.
►Press Push button 12 to change the setting of the respective param-
eter.
►Press Push button 10 to save and exit user settings.
- or -
After 40 seconds the setting options displayed will disappear and the
selected settings are saved.

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5.3.8 Available parameters for user modes
■Sensitivity: This parameter changes the brightness control. A low value
(-) causes the camera to reduce the brightness if there is a small bright
object. A high value (+) causes the camera to reduce the brightness if
the average of the complete image is too bright
■Focus: This parameter decreases (-) or increases (+) the digital detail
enhancement.
■Color: This parameter decreases (-) or increases (+) the color satura-
tion.
■Gain: This parameter decreases (-) or increases (+) the maximum value
of the dynamic gain. The camera reduces the dynamic gain automati-
cally if there is enough light in the image.
■Background: This parameter decreases (-) or increases (+) the bright-
ness of dark backgrounds.
■Red detail: This parameter decreases (OFF) or increases (LOW, HIGH)
the digital enhancement especially for fine red details.
■Image size: This parameter defines the image size for the brightness
measurement area. Settings are AUTO, LARGE, MEDIUM, SMALL.
■Fiberscope: The setting ON will deactivate the digital detail enhance-
ment to minimize the moiré effect for fiberoptical endoscopes.
5.3.9 Remote control of an external documentation system
To connect an external documentation system (e.g. Aesculap Eddy DVD or
any other suitable documentation system) to the mono jack for remote
control 16 labeled REMOTE:
►Connect remote control cable PV968 between the camera and the doc-
umentation system.
►For remote-controlling the external documentation system, press blue
Push button 3on camera head 5.
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.
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.

10
Aesculap®
Full HD 3CCD Camera system PV440
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 Preparation before cleaning
Camera head
►Reprocess the product immediately after use.
►Use suitable cleaning/disinfecting agents if the product is put away in
a wet condition.
6.5 Cleaning/disinfection
6.5.1 Product-specific safety instructions for the reprocessing pro-
cedure
6.5.2 Validated cleaning and disinfection procedure
CAUTION
Damage to the product due to improper handling
when reprocessing!
►Separate the camera head from the camera
control unit prior to reprocessing.
►Reprocess the camera head and the camera con-
trol unit separately.
DANGER
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.
CAUTION
Damage to, or destruction of the product caused by
mechanical cleaning/disinfection!
►Only clean and disinfect the product manually.
CAUTION
Damage to the product due to inappropriate clean-
ing/disinfecting agents!
►Only use cleaning/disinfecting agents approved
for surface cleaning. Follow the manufacturer’s
instructions for the respective cleaning/disin-
fecting agent.
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 which
–Ensure that cleaning and disinfecting agents
are approved for use on anodized aluminum,
plastics (PPSU) and stainless steel.
–do not attack softeners (e.g. in silicone).
►Observe specifications regarding concentration,
temperature and exposure time.
►Do not exceed the maximum allowable temper-
ature of 60 °C.
Validated procedure Special features Reference
Wipe disinfection for
electrical devices with-
out sterilization
■Camera control unit
– Chapter Wipe disinfection for electrical devices
without sterilization
Manual cleaning with
immersion disinfection
■Camera head
■Suitable cleaning brush
■20 ml disposable syringe
■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 medical compressed air
(pmax=5 bar)
Chapter Manual cleaning/disinfecting and sub-
section:
■Chapter Manual cleaning with immersion
disinfection

11
6.6 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).
6.7 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.
6.7.1 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 Step T
[°C/°F] t [min] Conc. [%] Water quality Chemical
IWipedisinfectionRT ≥1 - - Meliseptol HBV wipes 50 % Propan-1-ol
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 - - - -

12
Aesculap®
Full HD 3CCD Camera system PV440
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.
6.8 Inspection, maintenance and checks
►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.
►Check the product for any damage, abnormal running noise, overheat-
ing or excessive vibration.
►Set aside the product if it is damaged.
►Remove the moisture from the camera plug and check that the con-
tacts are dry.
6.9 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.
6.10 Sterilization
Working with disposable sterile covers
►Use suitable Aesculap disposable sterile covers. Follow the instructions
for use of the sterile covers.
Sterilization with Sterrad® 50, 100, 100S, 200 sterilization process
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 by the Sterrad® sterilization process 50, 100,100S or 200,
observing the following rules: Follow the manufacturer’s instructions
for use of the Sterrad® system. Use of a biological indicator is recom-
mended to confirm effective sterilization.
6.11 Storage
►Store sterile products in germ-proof packaging, protected from dust, in
a dry, dark, temperature-controlled area.
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.

13
7. 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.
8. Troubleshooting list
Malfunction Cause Remedy
No image on the monitor Device not powered Verify that all units are connected to mains con-
nector and switched on
Fuse blown Replace camera fuse T0.5 A L/250 V~
(TA020394)
Wrong video input activated If the monitor supports several channels: Make
certain 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 a new light cable/Have repaired by
manufacturer
Light source dimmed down Turn up the light source intensity
Endoscope optical system defective If the image is too dark even without the cam-
era: Use a different endoscope and have the
defective endoscope repaired by the manufac-
turer
Image fuzzy or poorly defined Object out of focus Turn the focus adjustment setting ring of the
zoom coupler until there is a sharp image
Debris on the endoscope tip Clean tip with a sterile cloth and isopropyl alco-
hol (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 if the front and rear windows of the
endoscope and the front window of the zoom
coupler are clean; if necessary, clean with iso-
propyl alcohol (70 %)
Use Aesculap Anti Fog Solution JG910 on the
window on the distal end 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 Push button 10 for the mode selection and
select the optimum light metering mode

14
Aesculap®
Full HD 3CCD Camera system PV440
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.
Fig. 3 Fuse replacement
Note
If the fuses burn out frequently, the device is faulty and should be
repaired, see Technical Service.
9. Technical Service
►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
Repairs handling camera systems:
Aesculap FLEXIMED GmbH
Repair Service
Robert-Bosch-Str. 1
79211 Denzlingen/Germany
Phone: [phone]
Fax: [phone]
E-mail: [email protected]
Telephone hotline for technical assistance with electrical devices and
device combinations:
Phone: [phone]
Other service addresses can be obtained from the address indicated above.
10. Accessories/Spare parts
Color bar displayed on the monitor Camera cable not connected to the camera con-
trol unit
Connect camera cable at the camera control
unit
Inaccurate color representation on the monitor White balance failed Initiate white-adjustment
Inappropriate monitor color settings Reset to factory setting
Video cable defective Replace video cable
Malfunction Cause Remedy
DANGER
Risk of fatal injury from electric shock!
►Unplug the device before changing the fuses!
WARNING
Risk of injury and/or malfunction!
►Do not modify the product.
Art. no. Designation
PV442 Camera head and camera cable
PV441 Camera cable
PV126S Endo-lens with zoom
PV127S Fixed focal length endo-lens
TA020394 Fuse set T 0.5 A L/250 V~

15
11. Technical data
Classification acc. to Directive 93/42/EEC
* Video format configurable in the main menu, see
Changing video formats
** 50 Hz/60 Hz or PAL/NTSC are switchable on the rear
panel of the device from series number 2000 and higher
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
PV442 Camera head and camera cable I
PV440 Camera control unit
Art. no. Designation
Mains power 100-240 V AC, 50 Hz to 60 Hz
Power consumption 45 VA
Image sensors 3 CCD sensor 1/3 Inch
Resolution 1920 x 1080 Pixel
Electronic Zoom 1.0x to 2.0x
Video outputs:
DVI-D
HD-SDI
RGB
S-Video
Video
1080p or 720p*; 50 Hz or 60 Hz**
Aspect ratio 16:9
1080i or 720p*; 50 Hz or 60 Hz**
Aspect ratio 16:9
1080i or 720p*; 50 Hz or 60 Hz**
Aspect ratio 16:9
PAL or NTSC**
Aspect ratio 16:9 or 4:3*
PAL or NTSC**
Aspect ratio 16:9 or 4:3*
Protection class
(acc. to IEC/DIN
EN 60601-1)
Camera head IPX7
Control unit IP20
Dimensions of control
unit (L x W x H)
305 mm x 75 mm x 305 mm
Dimensions of camera
head (without zoom
lens) (L x W x H)
40 mm x 53 mm x 72 mm
Applied part Type CF
EMC IEC/DIN EN 60601-1-2
Conforming to stan-
dard
IEC/DIN EN 60601-1
Operation Storage and transport
Temperature +10 °C to +40 °C -20 °C to +60 °C
Relative
humidity
0 % to 90 % (at +20 °C)
or
0 % to 50 % (at +40 °C),
non-condensing
0 % to 90 % (at +20 °C)
or
0 % to 50 % (at +40 °C),
non-condensing
Adhere to national regulations when disposing of or recy-
cling 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 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.

16
Aesculap®
Full HD 3CCD Kamerasystem PV440
Aesculap® Full HD 3CCD Kamerasystem PV44 0
Legende
1Endo-Objektiv (Bild beispielhaft)
2Grauer Knopf
3Blauer Knopf
4Kamerakabel
5Kamerakopf
6Kamerastecker
7Kamerakontrolleinheit
8EIN/AUS-LED
9Kameradisplay
10 Taste (zur Moduseinstellung)
11 Taste (zur Erhöhung der Helligkeit)
12 Taste (für den automatischen Weißabgleich)
13 Kamerabuchse
14 Taste (zur Verringerung der Helligkeit)
15 Taste (EIN/STANDBY)
16 Monobuchse für Fernbedienung (3,5 mm)
17 DVI-D-Videoausgang (High Definition)
18 50/60-Hz-Umschalter (ab Seriennummer 2000)
19 RGB-Videoausgang (High Definition)
20 S-VIDEO-Ausgang (Standard Definition)
21 VIDEO-Ausgang (Standard Definition)
22 HD-SDI-Videoausgang 1 (High Definition)
23 HD-SDI-Videoausgang 2 (High Definition)
24 EIN/AUS-Schalter
25 Netzanschluss
26 Anschluss für Potenzialausgleich
Symbole an Produkt und Verpackung
Achtung, allgemeines Warnzeichen
Achtung, Begleitdokumente beachten
Gebrauchsanweisung befolgen
Kennzeichnung von Elektro- und Elektronikgeräten
entsprechend Richtlinie 2002/96/EG (WEEE), siehe
Entsorgung
Anschluss für Potenzialausgleich
Sicherung
Anwendungsteil des Typs CF
Netzstrom EIN/STANDBY
Kamerabuchse
Taste für automatischen Weißabgleich oder zur Aus-
wahl im Kameramenü
Helligkeit
Taste zur Modus-Auswahl oder zum Schließen des
Kameramenüs
Taste zur Erhöhung der Helligkeit oder "Nach oben"
im Kameramenü
Taste zur Verringerung der Helligkeit oder "Nach
unten" im Kameramenü
Niedertemperatur- und Plasmasterilisation

17
Inhaltsverzeichnis
1. Geltungsbereich 17
2. Sichere Handhabung 17
3. Gerätebeschreibung 18
3.1 Lieferumfang 18
3.2 Zum Betrieb erforderliche Komponenten 18
3.3 Verwendungszweck 18
3.4 Funktionsweise 18
4. Vorbereiten und Aufstellen 18
4.1 Erstinbetriebnahme 18
Zubehör anschließen 19
Spannungsvorwahl 19
Netzanschluss 19
Videokabel anschließen 19
Endo-Objektiv anschrauben 20
4.2 Einstellungen 20
Hauptmenü aufrufen 20
Videoformat ändern 20
Displaysprache ändern 20
Hauptmenü verlassen 20
5. Arbeiten mit der Full HD Kamera 21
5.1 Bereitstellen 21
5.2 Funktionsprüfung 21
5.3 Bedienung 21
Endoskop mit Sterilüberzug anschließen 21
Automatischen Weißabgleich durchführen 21
Modus wählen 21
Licht, Schärfe und optisches Zoom einstellen 22
Digitales Zoom einstellen 22
Helligkeit einstellen 22
Einstellungen für benutzerdefinierten Modus einstellen 22
Verfügbare Parameter für benutzerdefinierte Modi 23
Externes Dokumentationssystem fernbedienen 23
6. Validiertes Aufbereitungsverfahren 23
6.1 Allgemeine Sicherheitshinweise 23
6.2 Allgemeine Hinweise 23
6.3 Vorbereitung am Gebrauchsort 24
6.4 Vorbereitung vor der Reinigung 24
6.5 Reinigung/Desinfektion 24
Produktspezifische Sicherheitshinweise zum
Aufbereitungsverfahren 24
Validiertes Reinigungs- und Desinfektionsverfahren 24
6.6 Wischdesinfektion bei elektrischen Geräten ohne
Sterilisation 25
6.7 Manuelle Reinigung/Desinfektion 25
Manuelle Reinigung mit Tauchdesinfektion 25
6.8 Kontrolle, Wartung und Prüfung 26
6.9 Verpackung 26
6.10 Sterilisation 26
6.11 Lagerung 26
7. Instandhaltung 27
8. Fehler erkennen und beheben 27
8.1 Sicherungswechsel 28
9. Technischer Service 28
10. Zubehör/Ersatzteile 28
11. Technische Daten 29
11.1 Umgebungsbedingungen 29
12. Entsorgung 29
1. Geltungsbereich
►Für artikelspezifische Gebrauchsanweisungen und Informationen zur
Materialverträglichkeit siehe auch Aesculap Extranet unter
www.extranet.bbraun.com
2. Sichere Handhabung
►Fabrikneues Produkt nach Entfernung der Transportverpackung und vor
der ersten Sterilisation reinigen (manuell oder maschinell).
►Vor der Anwendung des Produkts Funktionsfähigkeit und ordnungsge-
mäßen Zustand prüfen.
►„Hinweise zur elektromagnetischen Verträglichkeit (EMV)“ beachten,
siehe TA022130.
GEFAHR
Lebensgefahr durch elektrischen Stromschlag!
►Produkt nicht öffnen.
►Produkt nur an ein Versorgungsnetz mit Schutz-
leiter anschließen.
WARNUNG
Verletzungsgefahr durch Fehlbedienung des Pro-
dukts!
►Vor der Verwendung des Produkts an der Pro-
dukt-Schulung teilnehmen.
►Wenden Sie sich an die nationale B. Braun/
Aesculap-Vertretung, um Informationen bezüg-
lich der Schulung zu erhalte
VORSICHT
Kein Kamerabild wegen inkompatibler Komponen-
ten!
►Kamerakopf PV442 mit Seriennummer
≥ SN3000 nur mit Kamerakontrolleinheit
PV440 mit Seriennummer ≥ SN2000 verwen-
den.

18
Aesculap®
Full HD 3CCD Kamerasystem PV440
►Um Schäden durch unsachgemäßen Aufbau oder Betrieb zu vermeiden
und die Gewährleistung und Haftung nicht zu gefährden:
– Produkt nur gemäß dieser Gebrauchsanweisung verwenden.
– Sicherheitsinformationen und Instandhaltungshinweise einhalten.
– Nur Aesculap-Produkte miteinander kombinieren.
►Produkt und Zubehör nur von Personen betreiben und anwenden las-
sen, die die erforderliche Ausbildung, Kenntnis oder Erfahrung haben.
►Gebrauchsanweisung für den Anwender zugänglich aufbewahren.
►Gültige Normen einhalten.
►Produkt nicht in der Nähe entflammbarer Anästhetika betreiben.
►Netzkabel in regelmäßigen Abständen auf Leckstrom und korrekte
Erdung prüfen.
3. Gerätebeschreibung
3.1 Lieferumfang
Full HD 3CCD Kamerasystem PV440, bestehend aus:
■Full HD Kamerakontrolleinheit
■Full HD 3CCD Kamerakopf
■DVI-D-Kabel
■Gebrauchsanweisung
3.2 Zum Betrieb erforderliche Komponenten
Für einen endoskopischen Eingriff werden zusätzlich zum Kamerasystem
folgende Komponenten zur Visualisierung benötigt:
■Endo-Objektiv
■Netzkabel
■Endoskop
■Lichtquelle
■Lichtleitkabel
■Monitor
3.3 Verwendungszweck
Die Aesculap Full HD Kamera (HD = High Definition) ist eine endoskopi-
sche Videokamera zur Übertragung von Echtzeit-Videobildern eines star-
ren oder flexiblen Endoskops mittels eines Objektivs mit Endoskopadapter
an einen Videomonitor oder ein anderes Dokumentationsgerät.
Die Aesculap Full HD Kamera ist für alle endoskopischen Anwendungen
geeignet.
Derzeit wird die Kamera benutzt, indem sie mit einem Objektiv mit Endo-
skopadapter verbunden wird. Anschließend wird ein Endoskop mit Stan-
dardokular mit dem Endoskopadapter verbunden und durch den Greifme-
chanismus des Endoskopadapters an Ort und Stelle gehalten.
Aufgrund der überlegenen Bildqualität von 1920 x 1080 Bildpunkten und
des Vollbildverfahrens der Full HD Kamera ist sie die bevorzugte Kamera
für endoskopische Verfahren.
3.4 Funktionsweise
Ein Endoskop visualisiert das Operationsfeld, und ein Objektiv lenkt dieses
Bild auf die drei CCD-Sensoren, wo es in digitale Signale gewandelt wird.
Die Bildhelligkeit wird in Abhängigkeit von der Lichtintensität automa-
tisch angepasst (Autoshutter).
Über das Kamerakabel 4werden die digitalen Bildsignale an die
Kamerakontrolleinheit 7übertragen, wo die digitalen Daten zur Anzeige
auf dem Monitor verarbeitet werden.
PotenzialDas auf diese Weise verarbeitete Videosignal kann dann am
Videoausgabemonitor und von digitalen Dokumentationsgeräten abge-
griffen werden.
Das Kamerasystem bietet automatische elektronische Bildaufhellung für
Bereiche, die besonders schwer auszuleuchten sind, sowie fünf unter-
schiedliche vorgegebene und drei durch den Benutzer veränderbare
Modus-Einstellungen für verschiedene Operationssituationen.
Zur optimalen Farbwiedergabe ist das Videokamerasystem darüber hinaus
mit einem automatischen Weißabgleich ausgestattet.
Das Objektiv und eine zusätzliche elektronische Zoomfunktion gewähr-
leisten, dass das Bild auf dem Monitor optimal vergrößert angezeigt wird.
4. Vorbereiten und Aufstellen
Wenn die folgenden Vorschriften nicht beachtet werden, übernimmt
Aesculap insoweit keinerlei Verantwortung.
►Beim Aufstellen und Betrieb des Produkts einhalten:
– die nationalen Installations- und Betreiber-Vorschriften,
– die nationalen Vorschriften über Brand- und Explosionsschutz.
Hinweis
Die Sicherheit des Anwenders und des Patienten hängt u. a. von einer intak-
ten Netzzuleitung, insbesondere von einer intakten Schutzleiterverbindung
ab. Defekte oder nicht vorhandene Schutzleiterverbindungen werden häu-
fig nicht sofort erkannt.
►Gerät über den an der Geräterückwand montierten Anschluss für
Potenzialausgleichsleiter mit dem Potenzialausgleich des medizinisch
genutzten Raums verbinden.
Hinweis
Die Potenzialausgleichsleitung ist unter der Art-Nr. GK535 (4 m lang) bzw.
TA008205 (0,8 m lang) beim Hersteller erhältlich.
4.1 Erstinbetriebnahme
WARNUNG
Verletzungsgefahr und/oder Fehlfunktion des Pro-
dukts durch Fehlbedienung des medizinisch-elekt-
rischen Systems!
►Gebrauchsanweisungen aller medizinischen
Geräte einhalten.