Wolf HD Endocam 5509 User manual
Manual
EN
DE
This manual contains information that is subject to copyright. All
EN
registered trademarks but are not identified as such. It should therefore not be
assumed that the absence of the trademark indicates that any given designation is not subject to trademark protection.
Users of RICHARD WOLF GmbH-products should not hesitate to point out to us
any errors or unclarities in this manual.
Copyright © RICHARD WOLF GmbH
rights reserved. This manual should not be photocopied, duplicated on microfilm or otherwise copied or distributed, completely or
in part, without the approval of RICHARD WOLF GmbH.
Some of the parts and equipment referred to in this manual bear
Manufacturer
RICHARD WOLF GmbH
Pforzheimer Straße 32
75438 Knittlingen, Germany
www.richard-wolf.com
CE marking according to Directive 93/42/EEC
GA-A 250 / Index: 03-10-3.0
Model
HDC905/10000005566 02/0310/ama
EN
Symbols
Warning Latex free
Follow the instruction
for use
Symbol for type CF
equipment
Symbol for potential
equalization
Degrees of protection
provided by enclosures
(IP-Code)
Alternating current Waste management
Service
Symbols
Number of autoclaving
cycles
Do not get wet
Top-Bottom
Fragile
ON
(part of equipment)
Order number
Single use only
Sterile with ETO White balance
Lot no.
Serial number Output
Date of manufacture
Expiration day
Pieces, quantity
OFF
(part of equipment)
Power connected
Input
Table of Contents
1 Important User Notes ......................................................................................................................................................... 3
2 Safety Information.............................................................................................................................................................. 4
2.1 Hazards........................................................................................................................................................................................ 4
3 Device Purpose.................................................................................................................................................................... 8
3.1 Intended Use.............................................................................................................................................................................. 8
3.2 Device-inherent Dangers and Information....................................................................................................................... 8
4 Initial Device Startup .......................................................................................................................................................... 10
4.1 Scope of Delivery...................................................................................................................................................................... 10
4.2 Preparing the Device ............................................................................................................................................................... 10
4.2.1 Connecting the Camera Heads to the C-Mount Lens System ..................................................................................... 11
4.3 Camera Control Unit (CCU), Front........................................................................................................................................ 11
4.4 Camera Control Unit (CCU), Rear......................................................................................................................................... 12
4.5 Camera Head (User Part)........................................................................................................................................................ 14
4.6 Connecting the Equipment ................................................................................................................................................... 14
4.6.1 Connecting Camera Head with Camera Control Unit (CCU)........................................................................................ 14
4.6.2 Connecting Monitor and Endoscope.................................................................................................................................. 15
4.6.3 Connecting Potential Equalization...................................................................................................................................... 17
4.6.4 Connecting the Mains Connection Cable.......................................................................................................................... 17
4.6.5 Connecting an Endoscope to the Camera Head.............................................................................................................. 18
4.6.6 Performing White Balance .................................................................................................................................................... 18
4.6.7 Assigning Functions to Head Keys ...................................................................................................................................... 19
5 Operating the Device .......................................................................................................................................................... 20
5.1 Using the Quick Coupling...................................................................................................................................................... 20
5.2 Using a Sterile Cover/Sleeve ................................................................................................................................................. 21
5.3 Using Camera Head without C-Mount Lens System, e.g. on Microscope................................................................ 22
5.4 Camera Menus.......................................................................................................................................................................... 22
5.4.1 Start Menu ................................................................................................................................................................................. 22
5.4.2 User Menu.................................................................................................................................................................................. 22
5.4.3 Procedure Profiles .................................................................................................................................................................... 26
5.4.4 User Profiles............................................................................................................................................................................... 27
5.4.5 Assigning Functions to Head Keys ...................................................................................................................................... 27
5.4.6 Image Functions ....................................................................................................................................................................... 28
5.4.7 Additional Settings .................................................................................................................................................................. 29
5.4.8 Language .................................................................................................................................................................................... 29
5.5 Using the Head Key Functions.............................................................................................................................................. 30
6 Care and Maintenance........................................................................................................................................................ 33
6.1 User Part ..................................................................................................................................................................................... 33
6.1.1 Cleaning the User Part............................................................................................................................................................ 33
6.1.2 Disinfecting the User Part...................................................................................................................................................... 34
6.1.3 Sterilization of the User Part................................................................................................................................................. 35
6.2 Cleaning the Camera Control Unit (CCU) .......................................................................................................................... 36
7 Troubleshooting.................................................................................................................................................................. 37
8 Technical Data..................................................................................................................................................................... 38
9 Guidelines and Manufacturer's Statement - Electromagnetic Compatibility ................................................................... 41
9.1 Impact of Mobile and Portable HF Communication Devices....................................................................................... 41
9.2 Guidelines and Manufacturer’s Statement – Electromagnetic Emissions .............................................................. 41
9.3 Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity....................................... 42
9.4 Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity - for the Camera ...... 43
9.5 Recommended Safety Distances between Portable and Mobile HF Telecommunications Devices and the
Camera ........................................................................................................................................................................................ 44
10 Accessory List ...................................................................................................................................................................... 45
11 Glossary............................................................................................................................................................................... 47
12 Appendix............................................................................................................................................................................. 48
12.1 Return Form............................................................................................................................................................................... 48
Index.................................................................................................................................................................................... 49
EN
1 Important User Notes
Read the manual carefully and become familiar with the operation and function
of the device and the accessories before use during surgical procedures. Non-observance of the instructions listed in this manual can lead
• to life-threatening injuries of the patient,
• to severe injuries of the surgical team, nursing staff or service personnel, or
• to damage or malfunction of device and/or accessories.
technical data of the supplied product through continued product development.
marked with these words must be read especially attentively.
DANGER!
The safety and/or health of the patient, user, or a third party are at risk. Comply
with this warning to avoid injury to the patient, user, or third parties.
WARNING!
These paragraphs include information provided to the operator concerning the
intended and proper use of the device or accessories.
Important User Notes
EN
Subject to technical changesThe manufacturer reserves the right to modify the appearance, graphics, and
Please noteThe words DANGER, WARNING, and NOTE carry special meanings. Sections
NOTE!
Here you will read information about the maintenance of the device or the ac-
cessories.
3
EN
Safety Information
2 Safety Information
Federal Law (only for U.S. market) U.S. federal law restricts use of this device to u se by or on the ord er of a physi cian .
Exclusion of liability The manufacturer is not liable for direct or consequential damage and the war-
ranty is null and void if:
• the device and/or the accessories are improperly used, prepared, or maintained,
• the instructions and rules in the manual are not adhered to,
• non-authorized persons perform repairs, adjustments, or alterations on or to the device or accessories,
• non-authorized persons open the device,
• the prescribed inspection and maintenance schedules are not adhered to.
Receipt of technical documentation from the manufacturer does not authorize individuals to perform repairs, adjustments, or alterations on or to the device or accessories.
Authorized service technician Only an authorized service technician may perform repairs, adjustments, or al-
terations on the device or accessories and use the service menu. Any violation will
void the manufacturer's warranty. Authorized service technicians are only
trained and certified by the manufacturer.
Intended use The device may be used only as intended.
Care and maintenance The service and maintenance of the device and its accessories has to be carried
out as per instructions to ensure the safe operation of the device. For the protection of the patient and the operating team, check that the device is complete and
functional before each use.
Contamination Before shipping, decontaminate device and accessories in order to protect the
service personnel. Follow the instructions listed in this manual. If this is not possible,
• the product must be clearly marked with a contamination warning and
• is to be double-sealed in safety foil.
The manufacturer has the right to reject contaminated products for repair.
Waste management
This symbol indicates that the waste of electrical and electronic equipment must
not be disposed of as unsorted municipal waste and must be collected separately
instead. Please contact the manufacturer or an accordingly authorized disposal
or waste management company for further information.
2.1 Hazards
DANGER!
Technique and procedures
Only the physician can evaluate the clinical factors involved with each patient
and determine if the use of this device is indicated. The physician must determine the specific technique and procedure that will accomplish the desired clinical effect.
DANGER!
Check all factory settings.
Factory settings are not mandatory settings for the physician. The physician is re-
sponsible for all settings affecting the surgical procedure.
4
DANGER!
Original accessories
For your own safety and that of your patient, use only original accessories.
DANGER!
Not explosion-proof
The device is not explosion-proof. Do not use in an area where flammable anes-
thetic gases are present.
DANGER!
Risk of electrical shock
To prevent electrical shock, do not open this device. Never open this device your-
self. Refer servicing to qualified service personnel.
DANGER!
Professional qualification
This manual does not include descriptions or instructions for surgical proce-
dures/techniques. It is also not suitable for training physicians in the use of surgical techniques. Medical peripherals and devices may be used only by
physicians or medical assistants with the appropriate technical/medical qualification working under the direction and supervision of a physician.
Safety Information
EN
DANGER!
Function test
The function test must be performed prior to each surgery.
DANGER!
Sterile mediums and accessories
Always work exclusively with sterile substances and mediums, sterile fluids, and
sterile accessories if so indicated.
DANGER!
Replacement device and accessories
In case the device or any of the accessories fail during surgery, a replacement de-
vice and replacement accessories should be kept within easy reach to be able to
finish the operation with the replacement components.
DANGER!
Cleaning the device
Do not sterilize the device.
DANGER!
Condensation / Water penetration
Protect device from moisture. Do not use if moisture has penetrated the device.
5
EN
Safety Information
DANGER!
Replacing fuse
Replace the fuse only with a fuse of the same type and rating.
DANGER!
Device-inherent dangers
Read the warnings specific to this device in chapter 3.2 "Device-inherent Dan-
gers and Information".
DANGER!
Device defect
If a device defect is suspected or confirmed, do not use it. Make sure the device
can no longer be used until a qualified service technician conducts the appropriate tests and repairs.
DANGER!
Powered accessory
The residual current flowing through the patient could increase when using endoscopes with electrically powered accessories.
DANGER!
Obvious defects
Never use the device if it has obvious defects, especially if these involve the power plugs or the mains power supply connection cables. In this case have the de-
vice repaired by authorized service personnel.
WARNING!
Check to make sure the available mains voltage matches the data listed on the
type label attached to the back of the device. Incorrect voltage can cause errors
and malfunctions and may destroy the device.
WARNING!
Endoscope
The device may only be connected with endoscopes designed for and featuring
the technical specification permitting such a combined use. Any utilized endo-
scopes must comply with the most recent versions of EC 60601-2-18 and
ISO 8600.
WARNING!
Electrical Interference
(See chapter 9 "Guidelines and Manufacturer's Statement - Electromagnetic
Compatibility"). Electrical interference with other devices or instruments was
practically eliminated when developing this devices and none was detected during testing. However, if you still detect or suspect such interference, please follow these suggestions:
• Move this, the other or both devices to a different location
• Increase distance between used devices
• Consult an electro-medical expert
6
WARNING!
Leakage current
If more power consuming devices are connected simultaneously to one socket by
means of distribution boxes the sum of the individual leakage currents may exceed the tolerated limit values.
Safety Information
EN
7
EN
Device Purpose
3 Device Purpose
3.1 Intended Use
The camera is designed to be used in conjunction with endoscopes during minimally invasive surgery. The camera serves to transfer images from an endoscope
to a medical-grade monitor. The camera features a modular design and can be
ordered with different endofocus optical lens systems for different focal lengths.
The camera is designed for positioning on the viewing end of an endoscope but
can also be used in combination with a microscope.
WARNING!
Always use a sterile, disposable cover or sleeve (see chapter 5.2 Using a Sterile
Cover/Sleeve, page 21) when using the endoscopic camera or sterilize the camera as described in chapter 6.1.3 Sterilization of the User Part, page 35). Failure
to do so may lead to contamination of the sterile field and can cause infections.
The camera is an extremely small and light endoscopic device with excellent image quality due to a digital image processing system, perfect color display, and
ease of use. The camera head is connected with the camera control unit (CCU) via
an interchangeable cable. An interchangeable camera cable guarantees the easy
and inexpensive reuse of the whole system in case of a defective cable. Additional
optional modules are used to implement additional functionalities to control
other equipment as well as to control the camera from other devices or with a device control system.
Do not use the device if endoscopic surgery is contraindicated. This device may be used only in rooms equipped and outfitted as specified by VDE Rules 0107.
3.2 Device-inherent Dangers and Information
DANGER!
Explosion hazard
The camera is not intended for use in explosive ar-
eas. If explosive narcotic gases are used, the camera
control unit must not be operated in the danger
zone depicted below.
DANGER!
ON/OFF switch
The device is only completely disconnected from the mains power supply if the
power plug is unplugged from the shockproof safety socket. Using the ON/OFF
switch at the front of the device switches only the voltage of the camera head
off.
DANGER!
Installation
The electrical connections of the operating room where the equipment is used
must comply with the corresponding national requirements.
DANGER!
Danger of burns
Contact with the open end of an endoscope or a light cable connected to the light
source can result in burns due to the high energy of the emitted light. Avoid
long-lasting, motionless contact between the end of the endoscope and the patient’s tissue during endoscopic surgery. To avoid danger of burns, do not leave
8
an active light-light cable, with or without a connected endoscope, on or near
the patient.
DANGER!
Danger of ignition
Always comply with national regulations concerning avoiding the danger of ig-
nition caused by electrostatic charges.
DANGER!
Device type CF
Degree of protection against electric shock. The endoscope must not have an
electrical conductive connection to the casing of the camera control unit.
WARNING!
Ambient temperature
If the camera control unit is operated within an enclosed device tower or rack
system, the operating temperature within this tower may be higher than the
ambient room temperature. Therefore, always install the equipment in an environment compatible with the manufacturer's rated ambient temperature (see 8
Technical Data, page 38).
Device Purpose
EN
WARNING!
Peripheral devices
Additional peripheral equipment connected to interfaces of the medical monitor
has to meet the requirements of the following specifications: EN 60601-2-18 for
endoscopic devices and EN 60601-1 for electrical medical devices. All configurations have to comply with EN 60601-1-1 specifications. Whoever connects additional equipment to signal output or signal input is obliged to meet
requirements of the standard EN 60601-1-1.
WARNING!
Device interfaces
The device operator may never touch the interfaces of the device and the patient
at the same time.
WARNING!
Mobile telephones
The interference caused by electromagnetic waves (e.g. mobile telephones) affecting electronic devices is well known. These should be avoided.
WARNING!
Endoscopes and accessories
The outer surface of the endoscope and each endoscopically usable piece of additional equipment has to be checked to ensure that the area is free of rough
spots and/or sharp edges that could harm the patient.
9
EN
(1)
Initial Device Startup
4 Initial Device Startup
Delivery inspection Always check all parts and accessories of the device immediately after receiving
the shipment. The manufacturer considers only replacement claims that have
been immediately submitted or reported to a sales representative or an authorized service company.
4.1 Scope of Delivery
Check the delivered equipment for completeness. Compare delivered parts with the enclosed packing list.
Returning the device If it becomes necessary to return the device, use of the original packaging is re-
quired. The manufacturer does not take responsibility for damage that has occurred during transportation if the damage was caused by inadequate transport
packaging.
Please make sure that all required information has been supplied:
•Name of owner
•Address of owner
• Device type
• Serial number of the equipment (see identification plate)
• Detailed description of defect
4.2 Preparing the Device
It is the responsibility of the operator to ensure the device is safe and functions as intended when being used.
Setting up the device Place the device on a level surface and install in a dry environment. The ambient
temperature and humidity must meet the requirements mentioned in chapter8
Technical Data, page 38.
WARNING!
Check to make sure the available mains voltage matches the data listed on the
type label attached to the back of the device. Incorrect voltage can cause errors
and malfunctions and may destroy the device.
While using the device the patient must be treated and kept under observation with the usual medical care.
Establish sterile conditions, provided they are required.
WARNING!
Do not use in an area where heating sources or an opening or vent for air condi-
tioning and ventilation are present. Do not expose the unit to direct sunlight, excessive dust, vibrations, or mechanical shocks.
If the camera head is not in use, the protective cap or the lens protector (in case of adapted lens) must be attached.
10
(2)
• Remove protective cap (1) from camera head (2).
• The screw lens system onto camera head.
DANGER!
Never pull on the camera cable.
Never squeeze, compress, bend, or otherwise twist or spindle the camera cable.
This can damage the wires inside of the cable and cause image loss or cable failure.
4.2.1 Connecting the Camera Heads to the C-Mount Lens System
WARNING!
Before mounting the lens system, check whether the glass surface of the lens
and the camera head is dry and free of dust. Use a cotton pad (plastic or wood
holders or swabs, never any metal) soaked with alcohol to remove any dirt.
Initial Device Startup
EN
4.3 Camera Control Unit (CCU), Front
(3)
(1)
Please familiarize yourself with the individual elements on the front of the camera control unit (CCU).
(2)
(4)
(5)
(6)
(7)
(8)
(9)
(10)(11)
Fig. 4-1 Elements of the camera control
unit (CCU), front
(1) Camera cable jack
(2) Cursor key LEFT (ESC)
(3) Cursor key DOWN
(4) Menu key (OK)
(5) Cursor key UP
(6) Cursor key RIGHT
(7) White balance key
(8) ON key
(9) Camera head ON/OFF LED
(10) OFF key
(11) Power supply LED
11
EN
Initial Device Startup
Fig. 4-2 Elements of the camera control
unit (CCU), rear
(12) Mains socket
(13) Potential equalization
(14) HD/RGB output
(15) HD/DVI output
(16A) S-VIDEO output 1
(16B) S-VIDEO output 2
(17A) VIDEO output 1
(17B) VIDEO output 2
(18) Service interface RS232
(19) REMOTE connector
(20) SDI output*
(21) Digital outputs DV
*optional (only Model 5509201)
4.4 Camera Control Unit (CCU), Rear
(12)
(13)
(15)
RGBOUT
(16A)
OUT OUT OUT OUT
(16B)
1
S-VIDEO
21
VIDEO
2
(17A)
(14)
Please familiarize yourself with the individual elements in the rear of the camera control unit (CCU).
(17B)
SC-REMOTE SERVICE
(18)
(19) (20) (21)
SDI
Table 1: Elements of the rear side
(12) Mains power connection Power input
Mains socket: Mains power supply cable connection (comply with rated volt-
Mains socket
age!)
(13) Connection for potential equalization Potential equalization
(14) HD/RGB output: Output of the RGB video signal (15-pin SUB-HD connector plug,
HD/RGB output
resolution 1280x1024)
(15) HD-DVI output (connector socket DVI 24+5) corresponding with ITU-RBT.709
HD/DVI output
digital RGB 24 bit, resolution 1280x1024
(16A) S-Video output 1: Output socket for S-VHS systems (Y/C), separate output for
S-VIDEO output 1
luminance and chrominance
Y: 1 Vpp on 75 ohm
C: 0.3 Vpp burst on 75 ohm
(16B) S-Video output 2: Output socket for S-VHS systems (Y/C), separate output for
S-VIDEO output 2
luminance and chrominance
Y: 1 Vpp on 75 ohm
C: 0.3 Vpp burst on 75 ohm
(17A) VIDEO output 1: BNC output socket for composite video signal, 1 Vpp on 75 ohm VIDEO output 1
12
*optional
Initial Device Startup
Table 1: Elements of the rear side
(17B) VIDEO output 2: BNC output socket for composite video signal, 1 Vpp on 75 ohm VIDEO output 2
EN
(18) DATA connector: Serial interface RS 232 C (special cable required): For service
(null modem cable, 9-pin)
(19) REMOTE connector: For remote control functions (relay contacts), e.g. start/stop
of video recorder or video printer.
(20) VIDEO output: BNC output socket for SDI signal.
Digital video signal for the lossless transfer of video up to 300 m.
(21) Firewire/DV output (DV connection 4/6 pin, data rate 400 Mbit/s) Digital outputs
DATA
REMOTE
SDI output*
*optional
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