OR 1 FUSION Control WO 100 Instruction Manual June 2016

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, 06 / 2016 It is not permitted to forward or reproduce this document nor to use or disclose the contents thereof unless express consent is given. Violators will be sued for damages. All rights reserved as regards patents or utility models (DIN 34-1). Published by KARL STORZ GmbH & Co. KG Mittelstraße 8 Postfach 230 78503 Tuttlingen Germany Telephone: +49 7461 708-0 +49 7461 708-105 Fax: E-mail: [email protected] Internet: 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

3. 3 Technical data... 3-3 KARL STORZ OR1 FUSION CONTROL™

I

Contents

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... 4-2

5

Maintenance...5-1

5. 1 Safety instructions... 5-1 5. 2 Reprocessing... 5-1 5. 2. 1 Legal requirements... 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 Electromagnetic compatibility (EMC) information... 7-1

8

II

Subsidiaries...8-1

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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 type plate clearly identifies the device. • Device designation:

KARL STORZ OR1 FUSION CONTROL™

• Model 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 CONTROL™

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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.

33

WARNING: 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. • Inspection and maintenance work is carried out in accordance with the prescribed time intervals. • Initial commissioning has been performed.

1-2

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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

Date of publication

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 CONTROL™

1-3

Important information for safe use

Identification

Designation

Date of publication

Comments

IEC 60601-1-2 3rd Edition

General requirements for basic safety and essential performance

2007/(R) 2012

Harmonized standard

- Collateral standard: Electromagnetic compatibility -

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

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Important information for safe use

Directives & laws Identification

Designation

Date of publication

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 2012-04 System Regulation Medical Devices), United States

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 CONTROL™

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Important information for safe use

1. 6. 3 Intended use The KARL STORZ OR1 FUSION CONTROL® is designed for use in practices and operating theaters by qualified personnel. The KARL STORZ OR1 FUSION CONTROL® is an appliance (comprising hard 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 CONTROL® 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

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Important information for safe use

1. 8 Disposal • The device meets the requirements of 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.

33

WARNING: 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 CONTROL® is referred to as the device.

KARL STORZ OR1 FUSION CONTROL™

1-7

Important information for safe use

1-8

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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: Make sure that those persons working with the device have sufficient qualifications and training.

33

WARNING: Read this instruction manual thoroughly before operating the system. Read the section on safety instructions carefully to avoid putting your patients, personnel or yourself at risk.

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 products 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! Danger of an 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.

33

WARNING: Only operate the device at the voltage stated on the device's type plate.

33

WARNING: 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.

KARL STORZ OR1 FUSION CONTROL™

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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 installation of the operating room in which the device is installed and operated must comply with the applicable IEC standards.

33

WARNING: To avoid the risk of an electric shock, the device must only be connected to a power supply with a protective conductor.

33 33 33 33

WARNING: The device must only be operated under the ambient conditions specified.

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. If liquids penetrate the device despite the precautionary measures, sufficient time should be allowed for evaporation.

33

WARNING: The visualization of image signals which do not originate from a KARL STORZ device may only be used for information purposes.

33 33

WARNING: For safety reasons, do not simultaneously touch the device output sockets and the patient.

WARNING: Keep the device out of the reach of patients. WARNING: The device is only voltage-free when the power plug has been disconnected. WARNING: The device must be positioned so as to ensure that the power connection can simply be disconnected at any time.

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.

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Safety instructions

33

WARNING: The device is not suitable for operation in potentially explosive atmospheres. This means, for example, that when using easily combustible and explosive inhalation anesthetics or mixtures thereof, the device must not be operated in 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 CONTROL™

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Safety instructions

2-4

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Product description

3

Product description

3. 1 Technical description KARL STORZ OR1 FUSION CONTROL® is designed for use in the operating theaters of clinics and hospitals. KARL STORZ OR1 FUSION CONTROL® 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 CONTROL® 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 CONTROL™

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

CONNECT UNIT TO ‘HOSPITAL USE‘ OR ‘HOSPITAL GRADE‘ RECEPTANCLE ONLY

1

2

LineIn LineOut

3

3

SUNIX Comp Out

GENERAL I/0 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. Disconnect 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

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Product description

3. 3 Technical data Input voltage:

100 VAC – 240 VAC

Input frequency:

50 Hz – 60 Hz

Power consumption max:

350 W

Dimensions (mm):

305 x 165 x 355 (W x H x D)

Weight max.:

6.5 kg

Degree of protection:

IPX0

Hard drive capacity:

2 TB

DVD drive:

Sony optiarc Inc. BC-5650H

RAM:

8 GB

CPU:

Intel® CoreTM [email protected] GHz

Operating system:

Windows 7 Embedded

KARL STORZ OR1 FUSION CONTROL™

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Product description

3. 4 Connections 3. 4. 1 Front

a

b c

d

e

f

g

a. Power supply ON/OFF switch

e. CD/DVD eject button

b. Orange standby LED

f. CD/DVD slot

c. Green operating LED

g. USB port

d. LED for hard disk access

3. 4. 2 Back w

t

v u

qp o

s r

a Audo Out/ In

SCB Interface

b c

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

LineIn LineOut

3

3

DVI Out/ In

SERIAL SMARTSCREEN

FS

E x t e r n

Y/C Out

Comp In

Y/C In DVI 2

SDI Out

n m l k

DVI SDI In

HDMI

e f

+

+

g

h

i

j

a. Power supply

h. 3x RJ-45 (LAN)

p. Matrox audio input/output

b. Lemo 8-pin (footswitch)

i. 2x HD/SD SDI Input

q. DVI input/output

c. 4x 3.5 mini jack (camera head buttons)

j. 2x DVI (video input)

r. POAG earth connection

k. Y/´C input

s. Lemo 13-pin (GPIO)

l. Comp. input

t. PS/2 (keyboard)

m. Y/´C output

u. DE 9 (serial interface)

n. Comp. output

v. Mini jack (audio OUT)

o. RS232 (serial interface)

w. Mini jack (audio IN)

d. 2x DE 9 (serial interface) e. DVI (monitor) f. HDMI (monitor) g. 6x USB 2.0

3-4

Comp Out

DVI 1

R S 2 3 2

LAN SCB

d

SUNIX

GENERAL I/0

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