Instructions for Use
448 Pages
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Page 1
ZEISS
OPMI® PENTERO® 900 Software Release 1.2
Instructions for Use G-30-1822-en Version 1.8 2013-11-13
OPMI® PENTERO® 900
About this manual
Orientation aids
Scope
Trademarks
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.
•
Keep it for the entire service life of the system.
•
Pass it on to any subsequent owner or user of the device.
–
The chapter overview at the beginning of these Instructions for Use provides a summary of all subjects.
–
The contents of each chapter are specified in detail at the beginning of each chapter.
–
A list of abbreviations, key words and technical terms in the annex facilitates the search for specific terms.
The present instructions for use apply to the OPMI® Pentero® 900 with the following identification: –
Reference number: 302582-9902-000
–
Software-Release 1.2.0
OPMI®, PENTERO® are registered trade marks of ZEISS. AutoDrape™, SuperLux™, FlexiTrak™, MultiVision are trade marks of ZEISS.
Manufacturer
Carl Zeiss Meditec AG Goeschwitzer Strasse 51-52 07745 Jena Germany
Fax: + 49 (0) 7364 - 20 4823 E-Mail: [email protected] Internet: www.meditec.zeiss.com
Subject to changes 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 2013 All rights reserved. Reprints and reproductions, including excerpts, are not permissible. However, this 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 1.8 G-30-1822-en
Contents
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Safety Measures
9
Key to symbols
10
– Hazard symbols
10
– Information symbols
10
Target group
11
Range of application
11
– Intended use
11
– Normal use
12
Notes for the operator
13
Requirements for operation
16
– Prior to the very first use
16
– Before every use
16
– During use
17
– After every use
18
– Warranty and liability
18
– Risk of burn injuries caused by high illumination intensity
19
– Safety devices of the suspension system
22
Symbols and labels on the device
26
System Overview
43
– Procedure in case of trouble
46
– Special properties
48
– Surgical microscope and laser micromanipulator
50
– Video image injection in the surgical microscope (option *)
51
– Injecting navigation information in the surgical microscope *)
52
– Overall system structure
53
– Configuration options
56
Central user interface (touchscreen)
58
– Main menu
62
Controls and connections
64
OPMI® PENTERO® 900
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G-30-1822-en
– Binocular tubes and eyepieces
72
– Handgrips
76
– Superlux 330 illumination system
78
– Additional lighting
80
– Autofocus (focusing aid) (optional)
81
– Drape vacuum system (option)
82
– Stand base/FlexiTrak System
84
– Connector panel
88
Connecting navigation systems
96
Preparations for use
101
– Relocating the system
102
Assembling the system
104
– Configuration
104
– Mounting the tube and eyepieces
106
– Attaching documentation / coobservation equipment
108
– Mounting the mouth switch (accessory)
110
– Adjusting the position of the handgrips
114
– Attaching sterile drapes
115
– Positioning the system at the operating table
118
– Connecting an external monitor (option)
120
– System start
122
– Configuring the handgrips
124
Balancing the system
128
– Adjusting the surgical microscope
132
– USER menu / Login
134
– Enable IT system rights and data protection
138
– Configuration menu (CONFIG)
142
Operation
195
Checklist
196
Procedure
199
– Working with the surgical microscope
199
– Comfortable control via the mouth switch (pivoting)
200
– Working with the data injection system (option *)
202
OPMI® PENTERO® 900
Issue 1.8 Printed on 07. 02. 2014
Patient Files menu (PAT-FILES)
206
– Manage patient files
206
– View patient data
218
– View patient images
220
– Edit images
224
– Save
227
– Saving patientdata to USB
230
Procedure in the event of faults
237
– Illumination failure - changing the xenon lamp
238
– Failure of the zoom function
240
– Failure of the focusing function
241
– Failure or blocking of the magnetic brakes
242
– Failure of the touchscreen
242
– Computer failure (power supply intact)
243
– Error messages in data projection
243
– failure of the line voltage
244
– Failure of all control functions (LIGHT ONLY mode)
245
– Blocking individual magnetic brakes (The microscope cannot be moved at all or only to a limited extent) 246
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Troubleshooting
247
– For your safety
247
– Malfunctions of the system
248
– Malfunctions of the wireless foot control panel
250
– Malfunctions of the cable-based foot control panel
251
Care and Maintenance
253
– Care of the system
254
– Sterilization
256
– Disinfecting surfaces and control keys
256
– Maintenance intervals
257
– Changing the lamp module
262
Ordering data
264
– Ordering data of the OPMI PENTERO 900
264
–
269
Spare parts
OPMI® PENTERO® 900
Issue 1.8 Printed on 07. 02. 2014
– Monitor the device and electrical safety
270
– Disposal
271
System Data
273
– OPMI PENTERO 900
274
– Interface, OPMI PENTERO 900
279
– Video camera 3 CHIP PAL standard definition
283
– Video camera 3 CHIP NTSC standard definition
283
– Video camera 3 CHIP HD PAL
284
– Video camera 3 CHIP HD NTSC
285
– Ambient requirements
286
– Changes to the system
286
Approval data
287
EMC (electromagnetic compatibility)
289
– Electromagnetic interference
290
– Electromagnetic immunity for ME equipment and ME systems
291
– Electromagnetic immunity for non-life-supporting ME equipment and ME systems 293
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– Recommended safety distances between portable and mobile RF communication equipment and the OPMI® PENTERO® 900
295
System combinations
296
Annex (options)
297
Digital video recording (option)
299
Digital video recording (option)
300
– Description
300
– Video clips
305
– Edit video clips
307
INFRARED 800 with FLOW 800 (option)
313
Normal use
314
Description
318
– General configuration
318
– Description
320
– Configuring INFRARED 800
322
OPMI® PENTERO® 900
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– FLOW 800 description (option)
330
Preparations for use
342
– Connecting an external monitor (recommended option)
342
– Monitor display with standard definition video system
344
– Video outputs in the connection panel/display (standard definition) 345
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– Monitor display with high definition video system
346
– Video outputs in the connection panel/display (high definition)
347
– INFRARED 800 settings before every surgical procedure
348
– Checklist-function test INFRARED 800
349
Procedure
350
– IR 800 - SETUP Phase
350
– IR 800 - RECORD Phase
352
– IR 800 - PLAYBACK Phase
354
– FLOW 800 - analysis (option)
356
Fluorescence module BLUE 400 (option)
367
Integrated BLUE 400 (BL 400) fluorescence module
368
– Intended use
368
– Normal use
368
– Description
372
BL 400 checklist
376
Fluorescence module YELLOW 560 (option)
379
Integrated fluorescence module YELLOW 560
380
– Intended use
380
– Normal use
380
– Description
384
Checklist YE 560
388
DICOM (option)
391
DICOM
392
– Normal use
392
– Conformance Statement ("Konformitätserklärung")
392
– Configure network connection
394
OPMI® PENTERO® 900
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G-30-1822-en
– Further information on the Ethernet connection
400
– Connectivity test
402
– Configuring the DICOM connection
404
– Adding, editing and deleting a DICOM server
404
– Configuring the DICOM function
406
– Defining the maximum video export size to network servers
410
– Error messages during system configuration
414
– Importing patient data sets (from RIS systems)
416
– Importing patient data sets (from PACS system)
418
– Loading patient data
420
– Exporting DICOM data to a PACS
428
Indexes
431
List of technical terms
432
List of abbreviations
432
Keyword index
435
OPMI® PENTERO® 900
Issue 1.8 Printed on 07. 02. 2014
OPMI® PENTERO® 900
Safety Measures
Safety Measures
Key to symbols ... 10 Hazard symbols ...10 Information symbols...10 Target group ...11 Range of application...11 Intended use ...11 Normal use...12 Notes for the operator... 13 Requirements for operation... 16 Prior to the very first use...16 Before every use ...16 During use...17 After every use ...18 Warranty and liability...18 Risk of burn injuries caused by high illumination intensity ...19 Safety devices of the suspension system ...22 Symbols and labels on the device ...26
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Safety Measures
OPMI® PENTERO® 900
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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OPMI® PENTERO® 900
Safety Measures
Target group
CAUTION
Only to be operated by trained personnel! This user manual is intended for physicians, nurses and other medical staff who prepare, operate or maintain the system after appropriate training. It is the duty of the customer or institution operating the system to train and instruct all staff using the system. The first training after installation regarding preparation, operation, warning notices/risks, emergency operation and transport of the device is performed according to training protocol G-30-1714 in connection with the present user manual. Further trainings of the staff operating the system is performed by the operator according to this user manual.
Rx only
OPMI Pentero 900 with INFRARED 800 and the option FLOW 800 may only be used by physicians or and qualified medical staff authorized by said physicians.
Range of application Intended use OPMI PENTERO 900 is a surgical microscope intended for the illumination and magnification of the surgical area and for the support of visualization in surgical procedures.
CAUTION
Injury to the patient's eye! OPMI PENTERO 900 may not be used for ophtalmological procedures. •
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Make sure that no xenon light pr laser radiation enters the patient's eyes.
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Safety Measures
OPMI® PENTERO® 900
Normal use The complete system consists of a surgical microscope and a floor stand holding the electronic parts as well as a graphic touchscreen with video output. The OPMI PENTERO 900 is intended for cranial and spinal procedures in neurosurgery as well as for ENT treatments of auditory nerves and the base of the skull. It is furthermore used for reconstructing and plastic emergency surgery, plastic and reconstructive surgery and MCG surgery. The OPMI PENTERO 900 may be used for multidisciplinary use in microsurgery. It is designed for surgical operations that use endoscope and surgical microscope simultaneously. The system is equipped with a plug for a navigation system and data exchange with external network systems and intended for use in hospitals, medical centers and other institutions for human medicine. The functions of the surgical microscope and the floor stand are controlled via the central control unit in the panel. All settings are configured via an interactive graphic touchscreen display. It is possible to open the functions using the keys in the handle or via a foot panel. Installation conditions and device operation must conform to microsurgical requirements:
WARNING
–
Low vibration
–
Dust-free environment
–
Level, horizontal position
–
Avoidance of extreme mechanical loading
Function deterioration! We recommend you take adequate precautions, depending on the application, to enable the surgical procedure or treatment to be finished without using this microscope (for example in case of a system error).
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OPMI® PENTERO® 900
Safety Measures
Notes for the operator The correct use of the device is absolutely vital for safe operation. Therefore, please thoroughly familiarize yourself with the content of these Instructions for Use before starting up the device. Please also observe the Instructions for Use of additional instrument equipment. Further information is available from our service department or from authorized representatives.
Legal regulations
NOTE
•
Only operate the device within the scope of its intended use.
•
Only personnel who have undergone training and instruction are allowed to use this instrument. It is the responsibility of the customer or institution operating the equipment to train and instruct all staff using the equipment.
•
Please keep these Instructions for Use where they are easily accessible at all times for the persons operating the system.
•
Please observe all symbols and labels attached to the device (see Page 26)!
•
Please only use approved original accessories or consumables.
•
Observe the legal regulations for accident prevention and occupational health and safety applicable in the country concerned.
•
This system must not be modified without the manufacturer's approval. If the system is modified, suitable inspections and tests must be performed 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.
•
Modifications and repairs on these instruments or instruments used with them may only be performed by our service representative or by other authorized persons.
Secure network! The user (IT specialist) is responsible for suitable security measures (e.g. firewall) against unauthorized access from outside to the network the system is linked to.
NOTE
Virus free! The user is responsible for keeping the USB medium used for data exchange virus free.
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Safety Measures
OPMI® PENTERO® 900
Ambient requirements
Electrical safety
Transport & service
Page 14
•
If required by the regulations and directives applicable in the country of use, connect the system to a special emergency backup power supply.
•
Do not operate the system contained in the delivery package –
in explosion-risk areas,
–
if inflammable anesthetics or volatile solvents such as alcohol, benzine or similar chemicals are present at a distance of less than 25 cm.
•
Do not station or use the instrument in damp rooms. Do not expose the instrument to water splashes, dripping water or sprayed water.
•
Do not place any fluid-filled containers on top of the instrument. Make sure that no fluids can seep into the instrument.
•
Ensure that the installation requirements and the operation of the device concur with the surgical conditions: –
minimum vibration
–
clean environment
–
do not use the device under extreme mechanical stresses
•
Always switch off the system before disconnecting it from / connecting it to line power, for cleaning its surface or if it will not be used for a prolonged period of time.
•
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.
•
A potential equalization connector is provided on the connector panel. This connector can be used for placing other active devices at the same ground potential or for redundant grounding to protective earth.
•
Never open the device! The device contains freely accessible live components. If you remove the housing, you run the risk of electric shock.
•
Do not touch the system if your body is electrostatically charged and the system is not grounded.
•
Please note the information on EMC (electromagnetic compatibility) in the chapter "System Data" on Page 289.
•
Over longer distances (e.g. removal, return for repair, etc.) the system must always be transported in the original packaging or in special return packaging. For details, please contact your dealer or the Carl Zeiss service team.
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OPMI® PENTERO® 900
Optics and light
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Safety Measures
•
Risk of crushing - mind your fingers! Fingers may be crushed in areas marked with the label "Crushing Hazard". Do not touch these areas whilst the machine is being moved.
•
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.
•
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").
•
Modifications and repairs of this device or any equipment operated together with this device may only be performed by Carl Zeiss service staff or other persons authorized by Carl Zeiss.
•
Never directly look into the sun with binocular tube, object lens or an eyepiece.
•
Avoid looking directly into the light source, e.g. into the microscope objective lens or into the light guide, in order to prevent damage to the eye!
•
Start with the lowest brightness setting and gradually increase brightness up to the necessary and still admissible level.
•
With increasing age of the light source, the actual illumination intensity delivered at the respective setting decreases (this is a normal property of the system).
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Safety Measures
OPMI® PENTERO® 900
Requirements for operation Prior to the very first use Our service representative or an expert authorized by us 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 power cord has been plugged into a power outlet which has a properly connected protective ground contact. The power cord being used is the one designed for use with this system. When connecting the device to any network, please ensure the network is free of dangerous voltages.
Before every use
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•
Check the system balance before every use. If the system has been correctly balanced, the surgical microscope can be moved in all positions within the working area almost effortlessly.
•
To prevent accessories from falling down, check before every use that accessories are securely locked in position and securing screws are firmly tightened.
•
In order to prevent an unexpected response by the device, check the user settings of the software before every use.
•
Only use the device with suitable accessories.
•
Never cover any ventilation openings. This may cause the light source of the device to overheat and fail.
•
Check the surgical microscope for sufficient freedom of movement. The device itself or accessories may be damaged if conflicting with each other.
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OPMI® PENTERO® 900
Safety Measures
•
Never attempt to forcefully attach any electrical connections (plugs, bushings). If a plug cannot be connected easily, check again whether the plug and socket are made to fit. If the plug connection is damaged, please call our service department. They will be happy to assist you.
•
In order to avoid the device from rolling off inadvertently, use the locking mechanism on the base of the suspension system and secure the device.
•
Before using the wireless, foot control panel FCP WL ensure its batteries are fully charged. Inadequate power supply of the wireless foot control panel may lead to malfunctions of the device.
•
Go through the checklist in the chapter "Operation".
•
Avoid direct eye contact with the source of the light, e.g. at the lens of the microscope in order to avoid phototoxic damage to the eye.
•
Never leave a device unattended with the light source still switched on.
•
Defective or unidentified accessories may lead to increased leakage current. Never connect defective or unidentifiable accessories. Never touch power outlets or video interfaces while contacting the patient.
•
If the xenon lamp is used beyond its maximum service life of 500 hours, sudden failure may occur. Please replace the xenon lamp in due time. The display of the remaining service hours on the touchscreen will be reset automatically.
•
Only change the lamp module after it has cooled down (this takes approx. 10 min)! In case of malfunction, the high pressure inside the hot lamp may cause the lamp to burst. The hot surface of the xenon lamp may also cause burns.
•
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 device stating it is out of order and contact our service representative.
•
Do not pull at the light guide, power cord or any other connecting cables.
•
Never operate the system unattended.
•
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 the Carl Zeiss service team.
During use
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Safety Measures
OPMI® PENTERO® 900
After every use •
Always use the master switch to turn off the device if it is not in use.
•
Insufficient, faulty or wrong methods of cleaning or not disinfecting the device according to this instruction manual may severely increase the risk of infecting the patient and/or medical personnel.
Warranty and liability Warranty and liability depend on the applicable contractual stipulations. 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.
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OPMI® PENTERO® 900
Safety Measures
Risk of burn injuries caused by high illumination intensity CAUTION
If the xenon light is not used as intended, excessive illumination intensity may result in third-degree burns! General The OPMI PENTERO 900 features a powerful xenon lamp. If used improperly, excessive illumination intensities may lead to third-degree burns. •
Never leave a device unattended when its light source is switched on!
Various factors contribute to the risk of burn injuries: System-related factors: –
The wavelength range is limited by filters to the visible range between 400 nm and 700 nm (between 400 nm and 780nm only in IR 800 mode). These filters remain stable over a very long period of time and cannot be exchanged by the user.
–
The illumination intensity decreases with increasing number of operating hours of the light source. Once the lamp operating time of 500h is elapsed, the user is prompted (by a message on the touchscreen) to replace the lamp. This note is displayed at start-up of the system and disappears only after the user confirms the message.
–
Reduced light intensity If the magnification value selected is high, both the diameter of the field of view decreases and the light intensity at the surgeon's eye is reduced whereas the light intensity in the surgical field stays the same. This effect is increased by the use of certain accessories, e.g. eyepieces with higher magnification or the folding tube f170/f260 with tube magnification (PROMAG function). When working at maximum magnification, you should therefore pay particular attention to the set light intensity to prevent burns, especially of the surrounding tissue.
Surgery-related factors:
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–
The selected intensity of the light source is a major factor for the risk of injury. It should always be set to the minimum required for the surgical procedure to be performed.
–
The size of the luminous field influences the injury risk in two respects:
Page 19
Safety Measures
OPMI® PENTERO® 900
– For a large luminous field diameter, areas of the skin are illuminated which are not monitored as strictly by the surgeon and which are not moistened sufficiently. These areas represent a particular injury risk. Such injuries can be prevented by adjusting the luminous field diameter to the smallest size required for that particular operation. – If the luminous field is reduced in size, the intensity increases because the light focus becomes stronger. If the luminous field is reduced in size, the intensity should therefore also be reduced, if possible. –
A long surgical procedure increases the risk of injury, in particular if a standard procedure takes considerably longer than usual.
–
Injuries in the peripheral area can be prevented by covering this area with moist, sterile gauze. The gauze must be moistened at regular intervals to avoid that the area dries out or heats up. The risk is increased if dry drapes are used to cover such areas.
–
You should also take into account that some areas of the body may be more sensitive than others.
–
Certain preparations of the surgical field, local vasoconstrictive medications and incision drapes may also result in a higher risk of injury (drapes may heat up to varying degrees depending on their color and moisture content).
Patient-related factors: –
The general condition of a patient's health may contribute to the risk of injury.
–
The skin type may also play a major role in this respect.
–
Certain medications affect the sensitivity to light.
–
The interaction of heat and antimicrobial substances in incision foils may lead to an increased reaction of the patient to these substances.
Recommendations Due to the large number of different factors involved and the lack of scientific publications on this topic, Carl Zeiss cannot provide guidance on acceptable intensities and exposure durations. However, the OPMI PENTERO 900 has several features that can help the user to reduce the risk of burn injuries.
Page 20
–
The initial light intensity can be preset to a low value.
–
If used, drapes should also be re-moistened at regular intervals in order to prevent heat from accumulating underneath the drape.
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