Instructions for Use
90 Pages
Preview
Page 1
ZEISS
Stereo Video System TRENION 3D HD
Instructions for Use G-30-1906-en Version 2.2 06/05/2015
TRENION 3D HD
About this manual
Orientation aids
Scope
The Instructions for Use is part of the delivery package. •
Please read it carefully before using the device.
•
Keep it at the place where the system is used.
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Keep it for the entire service life of the system.
•
Pass it on to any subsequent owner or user of the device.
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Observe all safety precautions and warning symbols shown in this manual.
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There is a section summary at the beginning of the Instructions for Use which provides an overview of all the topics.
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You will also find a detailed Table of Contents at the beginning of each chapter.
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The index at the end of the manual will facilitate the search for specific terms.
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These Instructions for Use are applicable to the TRENION Stereo Video System 3D HD with reference number 303160-9500-000.
Information on the manufacturer: Carl Zeiss Meditec AG Goeschwitzer Strasse 51-52 07745 Jena Germany
Tel: + 49 (0) 7364 - 20-0 Fax: + 49 (0) 7364 - 20 4823 Email: [email protected] Internet: www.meditec.zeiss.com
Subject to change in design and scope of delivery and as a result of ongoing technical development. Printed in Germany. Copyright
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© Carl Zeiss Meditec AG 2015 All rights reserved. Reprints and reproductions, including excerpts, are not permissible. However, these Instructions for Use may be digitized and archived for internal use. Access to this data by third parties is not permissible and must be prevented.
Version 2.2 G-30-1906-en
Contents
G-30-1906-en
Safety Measures
7
Key to symbols
8
– Hazard symbols
8
– Information symbols
8
Target group
9
Field of use
9
– Intended use
9
– Normal use
9
Notes for the operator
11
– Duties of the operator
11
Requirements for operation
14
– Prior to the very first use
14
– Before every use
14
– During use
15
– After every use
15
Symbols and labels on the device
16
System Overview
19
System overview
20
– Combination options
21
– System cables - overview
22
Operating, display and function elements
24
– 3D monitor (front)
24
– 3D monitor (reverse side)
25
– Device trolley (front)
26
– Device trolley (reverse side)
27
– Stereo camera head
28
– CR camera repeater
29
Preparations for use
31
Attach camera head (minimum configuration)
32
TRENION 3D HD
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Attaching the camera head (face to face or co-observer)
34
Connecting the stereo camera head to the camera repeater
36
Connect the camera repeater to the TRENION 3D HD
38
Connecting the monitor connection cable
40
Connecting the TRENION 3D HD
42
Operation
45
Powering the system up and down
46
– Performing a white balance procedure (white bal)
47
– Double iris diaphragm
48
System Start
49
Procedure
50
Changing the location of the TRENION 3D HD
51
Procedure in case of trouble
53
Troubleshooting
54
– For your safety
54
– Malfunctions of the system
54
– Replace the fuses
58
Care and Maintenance
61
Care of the device
62
– Cleaning
63
Disinfection
64
System maintenance
65
– Checking the device and electrical safety
65
Environmental protection measures
66
– Note on disposal
66
System Data
67
Technical data
68
Approval data
71
Environmental conditions
72
– Scope of delivery
73
EMC (electromagnetic compatibility)
78
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– Electromagnetic interference
79
– Electromagnetic immunity for ME equipment and ME systems
80
– Electromagnetic immunity for non-life-supporting ME equipment and ME systems
81
– Recommended safety distances between portable and mobile RF communication equipment and the TRENION 3D HD
83
Keyword index
85
TRENION 3D HD
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TRENION 3D HD
Issue 2.2 Printed on 12. 05. 2015
TRENION 3D HD
Safety Measures
Safety Measures
Key to symbols ... 8 Hazard symbols ...8 Information symbols...8 Target group ...9 Field of use ... 9 Intended use ...9 Normal use...9 Notes for the operator... 11 Duties of the operator ...11 Requirements for operation... 14 Prior to the very first use...14 Before every use ...14 During use...15 After every use ...15 Symbols and labels on the device ...16
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Safety Measures
TRENION 3D HD
Key to symbols We would like to inform you about safety aspects which must be observed when handling this device. This chapter contains a summary of the most important information concerning matters relevant to instrument safety.
Hazard symbols The following safety information has been incorporated into the Instructions for Use. Please note this information and be particularly careful in these cases. WARNING
Warning label, which may refer to fatal injuries or severe injuries if precautions are not followed.
CAUTION
Indicating a hazard, which may lead to moderately severe injuries if risks are not avoided.
NOTE
Warning label, which may refer to minor injuries and property damages if precautions are not followed.
Information symbols The following information symbols are used in these Instructions for Use: –
Listing
Requirements for an action •
Prompt for action
Result of an action Additional information and hints
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TRENION 3D HD
Safety Measures
Target group
CAUTION
Only to be operated by trained personnel! These Instructions for Use are geared towards doctors/nurses/nursing staff and medical/technical experts, who prepare the system for use, operate or service the systemin accordance with the training they have received. It is the duty of the customer or institution operating the system to train and brief all the staff. The initial briefing after installation on preparing, using, warning information/dangers, emergency operation and transporting the device will take place in accordance with Briefing Protocol GA-1714 in connection with these Instructions for Use. Other training and briefing of the envisaged operating staff will be done by the customer or institution operating the device based on these Instructions for Use.
Field of use Intended use The TRENION 3D HD is a system for capturing, displaying and photographing live images during surgery.
Normal use The TRENION 3D HD is a system that is equipped with visualization, video recording and playback equipment. The system makes it possible to make high resolution stereo video signals as well as display the video signals available on a 3D monitor and to photograph the image data using an HD recorder during an operation. It can be used by interns/assistant doctors, trainees or third parties for educa-
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Safety Measures
TRENION 3D HD
tional and training purposes. The stereoscopic image data is used only for additional visualization and not as a decision-making basis for medical procedures. If the viewer's stereoscopic vision is impaired or malfunctioning, use of the 3D glasses is not recommended! The TRENION 3D HD is not intended for the permanent storage of data!
WARNING
Not for diagnostic purposes! It is not permitted to use the displayed video sequences and single images for the actual surgical procedure or to make medical decisions pertaining to the surgery. Do not use the video sequences, video clips (cut sequences) and single images for diagnostic purposes, as the TRENION 3D HD is not calibrated. The visualized images may therefore include deviations in scale, color and shape. This applies in particular, if the sequences, clips or images are viewed on a second monitor (outside the OR), as the transmission to a different monitor may lead to changes in the reproduction. The TRENION 3D HD system is used in the hospital operating room. The device may only be used or operated by:
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Assistants for visualization
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THE OR staff for visualization and archiving
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Students and visitors for visualization and viewing purposes
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Surgeons for additional visualization and information.
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TRENION 3D HD
Safety Measures
Notes for the operator Before using the system please make sure there is a permit in accordance with the local rules and laws for the place where the system will be used. You can obtain information on this from the dealer or manufacturer. The correct operation of the system is absolutely vital for its safe operation. Therefore, please thoroughly familiarize yourself with the content of these Instructions for Use before starting up the system. Please also observe the instructions of Use for the TRENION 3D HD's individual components (see Page 20) and the other system equipment. You can obtain additional information from ZEISS Service.
Duties of the operator •
Only use the device in accordance with the intended use (Page 9 ).
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Please observe all symbols and labels attached to the device (see Page 16)!
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Observe the legal regulations for accident prevention and occupational health and safety applicable in the country concerned.
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This equipment must not be modified without the manufacturer's approval. If the equipment is modified after consulting the manufacturer, appropriate examinations and tests must be performed to guarantee the further secure use of the device. The manufacturer is not liable for any damage caused by unauthorized use of the equipment. Furthermore, this will forfeit any rights to claim under warranty.
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If required by the regulations and directives applicable in the country of use, connect the system to a special emergency backup power supply.
Data protection
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The operator is responsible for data protection and to prevent the unauthorized access of data!
Ambient requirements
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Do not operate the system contained in the delivery package
Legal regulations
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in explosion-risk areas,
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if inflammable anesthetics or volatile solvents such as alcohol, benzine or similar chemicals are present at a distance of less than 25 cm.
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Safety Measures
TRENION 3D HD
Electrical Safety
Transport & Service
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Do not station or use the instrument in damp rooms. Do not expose the instrument to water splashes, dripping water or sprayed water.
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Do not place any fluid-filled containers on top of the instrument. Make sure that no fluids can seep into the instrument.
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Ensure that the installation requirements and the operation of the device concur with the surgical conditions: –
Minimum vibration
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Clean environment
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Do not use the device under extreme mechanical stresses
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The system can be operated in the patient environment.
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Always switch off the system before disconnecting it from / connecting it to electrical power supply, if it is not going to be used for a prolonged period of time or if you want to clean its surfaces.
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Switch off the unit at the power switch if you notice any smoke, sparks or unusual noise. Do not use the system until it has been repaired by our service team.
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The device is equipped with an equipotential connection. This connection can be used for connecting other active devices to the same ground potential or for redundant grounding with protective earth.
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Never open the device! The device contains freely accessible live components. If you remove the housing, you run the risk of electric shock.
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Plug never electrical components or other electrical accessories or out while the machine is in operation.
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Do not touch the system if your body is electrostatically charged and the system is not grounded.
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Please note the information on EMC (electromagnetic compatibility) in the chapter "System Data" on Page 78.
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The device may only be moved over long distances (e.g. relocation, return for repair etc.) in its original packaging or in special return packaging. Please contact your dealer or ZEISS Service.
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This system is a high-grade technological product. To ensure optimum performance and safe working order, we recommend having it checked by our service representative as part of regular scheduled maintenance.
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In order to prevent any impairment of the device's safety due to age, wear, etc., the user must ensure that the device is subjected to the necessary safety checks (see section "Care and Maintenance").
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TRENION 3D HD
Handling of the 3D glasses
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Safety Measures
•
Modifications and repairs of this device or any equipment operated together with this device may only be performed by ZEISS SERVICE or other specialists authorized by Carl Zeiss.
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The use of the 3D glasses included in the delivery scope makes it possible to see stereoscopically. Please observe the manufacturer`s handling and care instructions for the 3D glasses:
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Do not touch the lens surface of the 3D glasses.
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Do not store the 3D glasses in surroundings with high temperatures, such as near a heater or in an automobile.
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Do not expose the 3D glasses to excessive pressure so that they are not misshapen.
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Please ensure that the lens surface of the 3D glasses are not damaged while they are being worn, taken off or during transit.
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Do not wear the 3D glasses if they are worn, broken or damaged as a result of aging. Tiny scratches on the lens surface can affect the use of the glasses. If you look away from the monitor, the 3D effect is reduced or the colors in the image will switch.
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Immediately discontinue using the 3D glasses if you experience nausea as a result of not being able to tolerate the 3D view!
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Safety Measures
TRENION 3D HD
Requirements for operation
WARNING
Device must not be modified without manufacturer's approval. This system must not be modified without the manufacturer's approval. If the system is modified, suitable inspections and testing must be completed to ensure that it can still be used safely. The manufacturer is not liable for damage caused by unauthorized persons tampering with the device. Furthermore, this will forfeit any rights to claim under warranty.
Prior to the very first use A ZEISS Service representative or an expert authorized by ZEISS will install the system. Please make sure that the following requirements continue to be met for further operation: The connecting components have been properly connected. The screw connections have been firmly tightened. All cables and plugs are in perfect condition. The voltage set on the system corresponds to the rated line voltage on the site of installation. The main plug must only be connected to a socket with a faultless protective ground conductor.
Before every use
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The TRENION 3D HD trolley must be set up in such a way that there is no difficulty unplugging the electrical plug-in connector from the power supply network.
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Install the stereo camera head and connect it with the two camera cables. Check the function of the stereo camera before laying out the sterile drape.
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TRENION 3D HD
Safety Measures
•
Before attaching the stereo camera head onto the surgical microscope, please keep in mind the permitted maximum load capacity for the surgical microscope. The maximum load capacity of 6 kg (accessories) on the microscope body must not be exceeded.
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Always run cables in a manner that will not impede the user's movements.
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Do not exert any force when plugging in electrical plug-in connections (connectors, jacks). If connection is not readily possible, check whether the plug fits the socket. If you detect any damage to the plug-in connection, arrange for the damage to be repaired by ZEISS Service.
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Defective or unidentified accessories may lead to increased leakage current on the system and injure the patient. Never connect any defective or unidentified accessories and never touch the power outlet or video interfaces while in contact with the patient.
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If a failure occurs which you cannot correct with the aid of the chapter "What to do in the event of malfunctions attach a sign to the system stating it is out of order and inform ZEISS Service.
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Do not pull at the power cord or any other connecting cables.
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Always use the master switch to turn off the device if it is not in use.
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Insufficient, incomplete or defective cleaning or disinfection which does not comply with these Instructions for Use (seePage 64) can result in a considerable risk of infection for the patient or medical staff.
During use
After every use
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Safety Measures
TRENION 3D HD
Symbols and labels on the device
CAUTION
Observe the warning labels and signs! •
If you notice that any label is missing on your device or has become illegible, please contact ZEISS Service or one of our authorized representatives.
1 TRENION 3D HD device identification plate This label contains the following information: – Device name: TRENION 3D HD – Reference number – Serial number – Input voltage: 115 / 230 V~ – Supply frequency: 50/60 Hz – Connected load 650 VA (W) – Protection type: IP20 – CE label – Year of manufacture combined with the manufacturer's address SGS test symbol with applied standards – Disposal information, see chapter "Care and maintenance"
2 Rating plate for Stereo Camera Head" This label contains the following information: – Device name: SV camera - SCH – Reference number – Serial number – Input voltage: 12 V DC – Connected load: 20 VA (W) – Protection type: IP 20 – CE label – Year of manufacture combined with the manufacturer's address SGS test symbol with applied standards
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TRENION 3D HD
Safety Measures
– Disposal information, see chapter "Care and maintenance"
1
Camera repeater rating plate This plate contains the following information: – Device name: SV camera - CR – Reference number – Serial number – Input voltage: 100 / 240 V~ – Supply frequency: 50/60 Hz – Connected load: 20 VA (W) – Protection type: IP20 – CE symbol – Year of manufacture combined with the manufacturer's address SGS test symbol with applied standards – Disposal information, see chapter "Care and maintenance"
Camera Repeater
2 "Symbol - right camera channel"
Camera Repeater
3 "Symbol - left camera channel" "Symbol - output to camera
4 "Follow the Instructions for Use"
No decision based on visualized information.
5 No decisions may be made based on visual information. 6 "Video outputs" (depending on color) left/right 7 "Network connection"
8 "Components liable to damage from electrostatic charges"
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Safety Measures
TRENION 3D HD
9 " Do not climb on the equipment" 10 "Do not sit on the equipment"
11 "Maximum total load capacity of the TRENION 3D HD"
12 "Symbol - pressure point for opening" The drawer and the door are opened manually by pressing on the symbol PRESS
IR
REC
13 "Symbol IR receiver" This infrared receiver is used to control the SONY HD video recorder by means of the remote control which is supplied.
14 "Symbol - Recording status" LED lights up in blue: Recording of video signals activated LED off: Recording of video signals deactivated
15 "Potential equalization" relates to the mains voltage input port of the TRENION 3D HD"To connect the device to the potential equalization system. Fuse 2x T 800mA
16 "Fuse rating" relates to the camera repeater and the TRENION 3D HD Only use fuses with the correct electrical ratings. Here: 2x "inert" fuses with a rated value of 800 mA. 17 "Fuse rating" relates to the isolating transformer Only use fuses with the correct electrical ratings.
HD CCU
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18 "Symbol - CCU (camera control unit (depending on color)) left/right, front of camera repeater
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TRENION 3D HD
System Overview
System Overview
System overview...20 Combination options ...21 System cables - overview ...22 Operating, display and function elements ... 24 3D monitor (front) ...24 3D monitor (reverse side)...25 Device trolley (front) ...26 Device trolley (reverse side)...27 Stereo camera head...28 CR camera repeater ...29
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System Overview
TRENION 3D HD
System overview The TRENION 3D HD system consists of the following components: 1 2 3 4 5 6 7 8
Device trolley with isolating transformer (8) 3D monitor HD video recorder 2x CCU (camera control unit (TRIO 600) Stereo video converter Stereo camera head Camera repeater Isolation transformer (in the system trolley) Cables and accessories (see Page 73)
The "TRENION 3D HD" is fully assembled at time of delivery and is set up on site by ZEISS Service.
2
1 3 4 4 5 8
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