Instruction Manual
235 Pages
Preview
Page 1
KARL STORZ OR1 FUSION® System WO100
INSTRUCTIONS
KARL STORZ OR1 FUSION® System WO100
Instruction Manual KARL STORZ OR1 FUSION CONTROL™ WO100
Welcome Thank you for your expression of confidence in the KARL STORZ brand name. Like all of our other products, this product is the result of years of experience and great care in manufacture. You and your organization have decided in favor of a modern, high-quality product from KARL STORZ.
Copyright © KARL STORZ, 01. 2016 It is not permitted to forward or reproduce this document nor to use or disclose the contents thereof unless express consent is given. Any violations will result in an obligation to compensate for damages. All rights reserved in the event of patent issuance or utility model registration (DIN 34-1). Distributor KARL STORZ GmbH & Co. KG Mittelstrasse 8 PO Box 230 78503 Tuttlingen Germany Telephone: Fax: E-mail: Internet:
+49 7461 7080 +49 7461 708 105 [email protected] www.karlstorz.com
Contents
Contents 1
Important information for safe use...1-1
1. 1 Details for the identification of the device... 1-1 1. 2 Details for the identification of the instruction manual... 1-1 1. 3 Description of the groups of people... 1-1 1. 3. 1 Operators... 1-1 1. 3. 2 Users... 1-1 1. 3. 3 Specialist personnel... 1-1
1. 4 Information for operators... 1-2 1. 4. 1 Initial commissioning... 1-2 1. 4. 2 Availability of the instruction manual... 1-2 1. 4. 3 Warranty... 1-2
1. 5 Information for users... 1-3 1. 5. 1 Training in the operation of the device... 1-3 1. 5. 2 Obligation of the user to check and inform... 1-3
1. 6 Intended use of the device... 1-3 1. 6. 1 Marking... 1-3 1. 6. 2 Standards and directives... 1-3 1. 6. 3 Intended use... 1-6 1. 6. 4 Contraindications... 1-6 1. 6. 5 Warnings and cautions... 1-6
1. 7 Ambient conditions for operation and storage... 1-6 1. 7. 1 Ambient conditions for storage... 1-6 1. 7. 2 Ambient conditions for operation... 1-6
1. 8 Disposal... 1-7 1. 8. 1 Conventions in this instruction manual... 1-7
2
Safety instructions...2-1
2. 1 2. 2 2. 3 2. 4
Explanation of warnings and cautions... 2-1 General safety information... 2-1 Safety precautions at the site of installation... 2-2 Safety precautions during operation... 2-2
3
Product description...3-1
3. 1 Technical description... 3-1 3. 2 Symbols and labels... 3-1 3. 2. 1 Front of device... 3-1 3. 2. 2 Back of device... 3-2 3. 2. 3 Type plate... 3-2
KARL STORZ OR1 FUSION™
I
Contents
3. 3 Technical data... 3-3 3. 4 Connections... 3-4 3. 4. 1 Front... 3-4 3. 4. 2 Back ... 3-4
4
Installation...4-1
4. 1 Safety instructions... 4-1 4. 2 Unpacking... 4-1 4. 3 Installation and commissioning... 4-1
5
Maintenance...5-1
5. 1 Safety instructions... 5-1 5. 2 Reprocessing... 5-1 5. 2. 1 Legal specifications... 5-1 5. 2. 2 Safety instructions... 5-1 5. 2. 3 Required cleaning agents... 5-1 5. 2. 4 Required cleaning materials ... 5-2 5. 2. 5 Manual wipe-down disinfection... 5-2
5. 3 Maintenance and repair... 5-2 5. 3. 1 Maintenance plan... 5-2 5. 3. 2 Changing the BIOS battery... 5-2 5. 3. 3 Servicing... 5-2
5. 4 Repair program... 5-3 5. 4. 1 Return of defective devices to KARL STORZ... 5-3
5. 5 Limitation of liability... 5-3 5. 6 Warranty... 5-3
6
Accessories...6-1
7
Appendix...7-1
7. 1 Information on electromagnetic compatibility (EMC)... 7-1
II
96206579EN / BA
Important information for safe use
1
Important information for safe use
1. 1 Details for the identification of the device This instruction manual is intended solely for the device. The information on the identification plate clearly identifies the device. • Device designation:
KARL STORZ OR1 FUSION™
• Type designation:
WO100
1. 2 Details for the identification of the instruction manual The material number and version number of this instruction manual are specified on all pages.
1. 3 Description of the groups of people The following three groups of people are named in this instruction manual.
1. 3. 1 Operators The term operator applies to all individuals or legal entities: • Who use the device themselves or allow a third party to use it in a doctor’s practice, hospital, etc. and exercise actual physical authority over the device during operation. • It is incumbent upon the operator to provide a safe device and properly instruct the user in the operation and intended use of the device.
1. 3. 2 Users The term user applies to persons: • Who, due to their education and the appropriate training provided by the persons delegated by the operator, are qualified to operate the device and work with it. • Users are fully responsible for using the device safely and in accordance with its intended use.
1. 3. 3 Specialist personnel The term specialist personnel applies to persons: • Who have acquired their knowledge through professional training in the medical or medical-technical fields. • Who are able to assess their work on the basis of professional experience and instruction in the safety-related regulations and recognize potential dangers whilst carrying out their work. • In countries in which the performance of an activity in the medical or medical-technical fields is certified, the classification of individuals as specialist personnel assumes a corresponding accreditation.
KARL STORZ OR1 FUSION™
1-1
Important information for safe use
1. 4 Information for operators • This device is produced in accordance with state-of-the-art technology and is safe to operate. Nonetheless, the device may still be a source of risk, especially if it is operated by personnel who are not adequately trained or if it is used incorrectly and for a purpose other than its intended use. • The device must be operated, cleaned, and disinfected by specialist personnel only. • All of the assembly work, disassembly work and setting adjustments described in this instruction manual must only be carried out by trained specialist personnel who have been delegated to do so by the operator. • For safety reasons, actions or interventions which extend beyond those described in this manual must only be carried out by KARL STORZ or a company authorized by KARL STORZ. Before a company can receive this authorization, the service personnel of the company in question must successfully participate in a technical training course conducted by KARL STORZ. Authorization is then granted for a fixed period of time.
1. 4. 1 Initial commissioning • This instruction manual is valid following an initial commissioning procedure which has been properly carried out. • The device must be thoroughly cleaned and disinfected before initial use.
1. 4. 2 Availability of the instruction manual • The instruction manual is a component of the device and must therefore be kept at a location in the immediate vicinity of the device to enable reference to safety instructions and important information regarding its use at any time. • Do not pass the device on to a third party without a valid instruction manual. With the aid of the identity number and version number, ensure that an up-to-date, valid instruction manual is passed on with the device.
1. 4. 3 Warranty KARL STORZ guarantees the safe and proper functioning of the device only subject to the following conditions: • The device is used only as designated and operated in accordance with the information provided in this manual. • Only original replacement parts or accessories which are defined and approved by KARL STORZ GmbH & Co. KG are used. The use of other parts poses unknown risks and must be avoided at all times. • No structural modifications are made to the device. Unauthorized modifications or alterations to the device or the software are not permitted for safety reasons and void the guarantee. • Inspections and maintenance work are carried out in accordance with the prescribed time intervals. • Initial commissioning has been performed.
1-2
96206579EN / BA
Important information for safe use
1. 5 Information for users • All of the actions described in this instruction manual must only be carried out by trained specialist personnel who have been delegated to do so by the operator.
1. 5. 1 Training in the operation of the device • Training must be conducted by KARL STORZ, a company authorized by KARL STORZ, or a person delegated by the operator, and must provide direct, practical experience of operating the device. • When the training has been completed, the user’s understanding of the special actions required to operate the device in accordance with its intended use must be documented.
1. 5. 2 Obligation of the user to check and inform • Read this instruction manual carefully before using the device for the first time. This is the best way to get the most out of the device and avoid potential injuries and material damage. • The user must inspect the device to ensure that it is in proper condition and functioning correctly before every use or before handing it over for use by a third party. • If particular problems arise which are not addressed in sufficient detail for you in this instruction manual, please consult your supplier for your own safety.
1. 6 Intended use of the device 1. 6. 1 Marking CE conformity marking: With this marking, the manufacturer declares the compliance of the products with the applicable standards and directives. CSA certification mark for the USA and Canada: With this marking, the manufacturer declares compliance with the energy efficiency and certification requirements. The manufacturer declares the conformity of this device with the essential requirements outlined in Annex I of the MDD and documents this by means of the CE mark.
1. 6. 2 Standards and directives The device complies with the safety requirements of the following standards and directives:
List of applied standards Identification
Designation
Publication date
Comments
Medical devices – Quality management systems – Requirements for regulatory purposes / Correction 1
2003-07 / 2009-08
Harmonized standard
Medical devices – Application of risk management to medical devices
2007-03
Comments ISO 13485 / Cor 1 ISO 14971
EN ISO 13485:2012 Harmonized standard EN ISO 14971:2012
IEC 62304
Medical device software – Software life cycle 2006-05 First processes Edition
IEC 62366
Medical devices – Application of usability engineering to medical devices
Harmonized standard EN 62304:2006
2007-10
Harmonized standard EN 62366:2008
KARL STORZ OR1 FUSION™
1-3
Important information for safe use
Identification
Designation
Publication date
IEC 60601-1-2 3rd Edition
General requirements for basic safety and essential performance
2007/(R) 2012 Harmonized standard
– Collateral standard: Electromagnetic compatibility –
Comments
EN 60601-1-2:2007
Requirements and tests IEC 60601-1 2nd Edition
Part 1: General requirements for basic safety 1988 and essential performance
Harmonized standard EN 60601-1:1990 + A1:1993 + A2:1995 + A13:1996
IEC 60601-1-1 2nd Edition IEC 60601-1-4 2nd Edition
Medical electrical equipment
2000
Part 1-1 – Collateral Standard: Safety Requirements for Medical Electrical Systems Part 1:
EN 60601-1-1:2001 1996
General requirements for safety
Harmonized standard EN 60601-1-4:1996 + A1:1999
4. Collateral Standard: Programmable electrical medical systems IEC 60601-1 3rd Edition
Harmonized standard
Part 1: General requirements for basic safety 2012 and essential performance
Harmonized standard EN 60601-1:2006
EN 1041
Information supplied by the manufacturer of medical devices
2008
Harmonized standard EN 1041:2008
UL 60601-1
Medical device safety
CAN/ CSA C22.2 No.601.1-M90
Medical Electrical Equipment – Part 1: General Requirements for Safety
R2005
EN 15223-1
Symbol standard for devices
2012
ISO 14155
Clinical investigation of medical devices for human subjects -- Good clinical practice
2011
Harmonized standard EN ISO 14155:2011
Biocompatibility/Cleaning/Disinfection/Sterilization IEC 60601-1 3rd Edition
1-4
Part 1: General requirements for basic safety 2012 and essential performance
Clause 11.6.6 Cleaning and Disinfection
96206579EN / BA
Important information for safe use
Directives & laws Identification
Designation
Publication date
93/42 EEC amended 2007/47 EC
MDD Essential Requirements
1993-07 amended 2007-09
2011/65/EU (RoHS)
Restriction of the use of certain hazardous substances in electrical and electronic equipment
2011
2012/19/EU (WEEE)
waste electrical and electronic equipment
2012
ISTA 3A
Packaged-Products for Parcel Delivery System Shipments
2008
MPG
Medical Devices Act
1994-08
CFR Part 820
Code of Federal Regulation Part 820: (Quality System Regulation Medical Devices), United States
2012-04
GHTF Essential Principles
Global Harmonized Task Force
2012
Code of Federal Regulation Labeling Requirements
1976
Comments
Directives
Laws
(GHTF/SG1/ N68:2012) 221 CFR 801
KARL STORZ OR1 FUSION™
1-5
Important information for safe use
1. 6. 3 Intended use The KARL STORZ OR1 FUSION™ is designed for use in practices and operating theaters by qualified personnel. The KARL STORZ OR1 FUSION™ is an appliance (comprising hardware and software) for the documentation of audiovisual data and patient data during diagnostic and therapeutic interventions. It allows the operation to be recorded and described for documentation purposes. The audiovisual data which is recorded and forwarded using the KARL STORZ OR1 FUSION™ is for examination and information purposes, and not primarily for making diagnoses. The recorded audiovisual data is not intended to be shown intraoperatively on the operation monitor.
1. 6. 4 Contraindications No contraindications were known at the time of printing. The use of this device is generally contraindicated if, in the opinion of an experienced physician, such an application presents an unjustifiable risk to the patient's health, e.g., due to the general condition of the patient.
1. 6. 5 Warnings and cautions The video signals and recordings shown may display artifacts as a result of compression and/or scaling. The image preview on the touchscreen is not intended to be used for diagnostic or therapeutic purposes. Signals in 3D are only correctly displayed on suitable display devices. The visualization of image signals which do not originate from a KARL STORZ device may only be used for information purposes. The data recorded with the system may only be used for documentation purposes, in particular • Image information in printed form • Image information which was compressed or recorded in non-native resolution • Image information which originates from or was recorded by a device which was not manufactured by KARL STORZ.
1. 7 Ambient conditions for operation and storage Different ambient conditions apply for the operation and intermediate storage of the device.
1. 7. 1 Ambient conditions for storage • Ambient temperature:
-10°C to 60°C
• Relative humidity:
10% to 90%
• Air pressure:
500 hPa to 1080 hPa
1. 7. 2 Ambient conditions for operation
1-6
• Ambient temperature:
5°C to 35°C
• Relative humidity:
10% to 90%
• Air pressure:
500 hPa to 1080 hPa
96206579EN / BA
Important information for safe use
1. 8 Disposal • The device meets the requirements of the Directive 2011/65/EU RoHS (on the restriction of the use of certain hazardous substances in electrical and electronic equipment) and old electronic devices (waste electrical and electronic equipment – WEEE). • In order to avoid causing harm to the environment and to persons, we ask that you contact KARL STORZ GmbH & Co. KG, a KARL STORZ subsidiary or your specialist dealer for information on your local collection point if you permanently decommission the device with the aim of disposal. • The device must be disposed of in accordance with the applicable national regulations at a suitable collection point for the recycling of electrical and electronic equipment. • Within the scope of application of this Directive, KARL STORZ GmbH & Co. KG is responsible for the proper disposal of this device.
1. 8. 1 Conventions in this instruction manual In this instruction manual the KARL STORZ OR1 FUSION™ is referred to as the device.
KARL STORZ OR1 FUSION™
1-7
Important information for safe use
1-8
96206579EN / BA
Safety instructions
2
Safety instructions
2. 1 Explanation of warnings and cautions The words Warning, Caution and Note convey special meanings. Wherever they are used in this manual, they should be carefully reviewed to ensure the safe and effective operation of this system. To make these words stand out more clearly, they are accompanied by a pictogram.
33
WARNING: A Warning indicates that the personal safety of the patient or user may be endangered. Failure to observe a Warning could result in injury to the patient or user.
22
CAUTION: A Caution indicates that particular service procedures or precautions must be followed to avoid possible damage to the system.
11
NOTE: A Note indicates special information about operating the system, or clarifies important issues.
2. 2 General safety information
33
WARNING: Installation and commissioning of the device must only be performed by authorized, electrotechnically qualified specialists from KARL STORZ GmbH & Co. KG or by an authorized contractual partner.
33
WARNING: Combinations of medical devices are only assured to be safe if they are identified as such in the respective instruction manuals or the intended use and interface specifications of the devices used in combination permit this.
33
WARNING: Grounding reliability can only be achieved when the equipment is connected to ‘a Hospital Only’ or ‘Hospital Grade’ outlet (i.e., approved for use in an operating room environment). Routinely inspect electrical plug and cord. Do not use if inspection reveals damage.
33
WARNING: Do not open the device! Risk of electric shock. Refer servicing to the manufacturer or the manufacturer’s authorized service personnel. Removal of the cover by non-authorized personnel will void the warranty.
33
WARNING: The instruction manuals and interface specifications for medical devices and/or system components used in combination must be observed precisely.
22
CAUTION: Only the software and hardware components which have been tested and approved by KARL STORZ and listed in Chapter 2.1.1 of the system description 96206541xx may be used. The maximum permitted values on the inputs and outputs of the device must be observed. If components are connected which exceed these values this will void the warranty.
22
CAUTION: Only operate the device with the voltage stated on the device's type plate.
KARL STORZ OR1 FUSION™
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Safety instructions
2. 3 Safety precautions at the site of installation 11
NOTE: Only those parts of the system which are approved as medical devices are suitable for use within the patient environment.
33
WARNING: The electrical installations in the operating room in which the device is installed and operated must comply with the applicable IEC standards.
33 33 33
WARNING: Risk of fire due to overheating! Observe and control the permissible ambient temperature.
33
WARNING: The device must be installed free-standing so as to ensure sufficient ventilation.
33
WARNING: It is the user's responsibility to make sure all devices connected to the system and the complete system are safe and operate properly before using them. The device should not be used if any damage is evident.
33
WARNING: Avoid allowing liquids to enter the device. Do not store any liquids in the vicinity of the device.
33
WARNING: The display of image signals which do not originate from a KARL STORZ device may only be used for information purposes.
33
WARNING: Switchover of the input signal during an ongoing intervention must only be performed once consent and confirmation is obtained from the surgeon.
33 33
WARNING: For safety reasons, do not simultaneously touch the device output sockets and the patient.
33
WARNING: The cable connections of the Smartscreen and AIDA must not be disconnected during operation.
WARNING: Set up the device out of the reach of patients. WARNING: Always unplug the device from the power supply before carrying out any maintenance work.
2. 4 Safety precautions during operation
2-2
WARNING: If the volume of the loudspeaker or the headphones is too high, an unexpected audio signal could startle the attending physician. Check volume regulation before each procedure.
96206579EN / BA
Safety instructions
33
WARNING: The device is not suitable for operation in potentially explosive atmospheres. This means, among other things: Wherever easily combustible and explosive inhalation anesthetics and their mixtures are used, the device may not be operated in the demarcated hazard zone. This also applies for easily combustible and explosive chemicals, e.g., skin disinfectants and fast-acting surface disinfectants.
60°
KARL STORZ OR1 FUSION™
2-3
Safety instructions
2-4
96206579EN / BA
Product description
3
Product description
3. 1 Technical description The KARL STORZ OR1 FUSION™ is designed for use in the operating theaters of clinics and hospitals. The KARL STORZ OR1 FUSION™ serves to aid the implementation and documentation of medical interventions aimed at examining and treating patients. When performing medical interventions, the KARL STORZ OR1 FUSION™ can be used to do the following from the central touch screen: • Control non-medical devices • Transfer and display video and audio signals from the integrated signal sources to the integrated peripheral devices • Record, save, edit, forward and print medical examinations and interventions in the form of still images and video and audio sequences
3. 2 Symbols and labels 3. 2. 1 Front of device
+
Observe the instruction manual! USB port Standby. The device is in Standby mode. Yellow pilot lamp. ON. Device switched on. Green pilot lamp. Access to hard disk. Orange pilot lamp.
KARL STORZ OR1 FUSION™
3-1
Product description
3. 2. 2 Back of device
Audo Out/ In
SCB Interface LASER KLASSE 1 PRODUKT NACH IEC B25 CLASS 1 LASER PRODUCT TO IEC B25
ACC
1
CONNECT UNIT TO ‘HOSPITAL USE‘ OR ‘HOSPITAL GRADE‘ RECEPTANCLE ONLY
2
3
Comp Out
GENERAL I/0
LineIn LineOut
3
SUNIX
DVI Out/ In
SERIAL SMARTSCREEN
FS LAN SCB
DVI 1 E x t e r n R S 2 3 2
SDI Out
Y/C Out
Comp In
Y/C In DVI 2
DVI SDI In
HDMI
+
+
Dangerous voltage. Risk of electric shock. Pull out the power plug before opening the housing Potential equalization
+
Network connection
LASER KLASSE 1 PRODUKT NACH IEC B25 CLASS 1 LASER PRODUCT TO IEC B25
USB port Laser class I Device in accordance with IEC B25
3. 2. 3 Type plate
CE conformity marking With this marking, the manufacturer declares the compliance of the product with the applicable standards and directives CSA certification mark for the USA and Canada With this marking, the manufacturer declares compliance with the energy efficiency and certification requirements Control of pollution caused by electronic information products (China RoHS) Separate collection of electrical and electronic devices. Do not dispose of as municipal waste 3-2
96206579EN / BA