VMC-1 DOCUMENTATION SYSTEM Instructions for Use Oct 2012

Contents 1 General Information...5 1.1 User Instructions...5 1.2 Conventions...5 1.3 Manufacturer/Distributor...5 1.4 Trademarks...6 2 Safety Information...7 3 Upon Delivery...10 4 Product Description...11 4.1 VMC‑1...11 4.2 Switching On/Off the VMC-1...12 4.3 Interfaces for attachable Devices...12 4.4 Symbols...13 4.5 Warranty...13 5 Repair and Disposal...14 5.1 Repair...14 5.2 Disposal...14 6 Cleaning and Disinfecting...15 7 Technical Data...16 7.1 Electrical specifications...17 7.2 Ambient Conditions...17 8 Electromagnetic Compatibility...18 9 Maintenance...22 9.1 Inspection...22 9.2 Replacing the Fuse...22

1 General Information 1.1 User Instructions •• Before use, thoroughly read this instructions for use and the instructions for use of all other products that will be used during the procedure. •• If the required instructions for use are missing, immediately contact an Olympus representative. •• Keep the instructions for use in a safe, accessible location.

1.2 Conventions This is the safety alert symbol. It is used to alert the user to potential physical injury hazards. •• Observe all safety messages that follow this symbol to avoid possible injury. This is a safety alert symbol. It is used to alert the user of the presence of hazardous voltage. •• Observe all safety messages that follow this symbol to avoid possible injury. Indicates additional helpful information. 1. A numeration indicates a sequence of actions. 2. •• Bullet points indicate individual actions or different options for action -- Dashes indicate the listing of data, options or objects. 1) Numbers with right parenthesis name elements in illustrations. <example> Bracketed terms refer to elements in the graphical user interface. Such elements can be: -- buttons -- menu items -- dialog elements

1.3 Manufacturer/Distributor Manufacturer PENTA GmbH Zeppelinstrasse 2 82178 Puchheim Germany Initial distributor Olympus Winter & Ibe GmbH Kuehnstr. 61 22045 Hamburg Germany

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1.4 Trademarks -- Intel® -- Intel® Core™ are trademarks of their respective owner.

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2 Safety Information The following safety messages apply to the general handling of the product. This information is to be supplemented by the safety messages given in each chapter in this document or in the instructions for use of any product being used with this product. Computer components are highly sensitive devices. ESD and wrong treatment can damage the VMC‑1. Do not open the VMC‑1. No user‑serviceable parts inside. For service, contact an authorized service center. Only use an original power-supply. If you need to use another power-supply, Contact an Olympus representative or an authorized service center for authorisation. Non observance can result in property damage, severe personal injury and the loss of the warranty. Before connecting the power cable all peripheral devices (e.g. keyboard or mouse) must be connected to the VMC‑1. Non observance can result in property damage. Never use the product if the power cable is damaged. By taking appropriate safety measures and carefully laying the power cable, ensure that the cable cannot be damaged and that no one can be hurt, by e.g. tripping over the cable or suffering an electric shock. Do not insert the plug into sockets that are dusty and dirty. Insert the plug firmly and all the way into the socket. Otherwise this can result in sparks, fire and/or injuries. Do not overload any sockets, extension cords or connector strips. Doing so can case fire or electric shocks. Operating is permitted only on sockets with earthing contact and protective earth connection. Intentionally breaking the protective earth connection either in the feed line or in the product itself is not permitted. Doing so can result in the danger of an electric shock from the product. If extension cords or connector strips are implemented, the must be checked on a regular basis to ensure that they are safe to use. Use suitable overvoltage protection to ensure that no overvoltage (e.g. such as that caused by a thunderstorm) can reach the product. Otherwise the operating personnel will be endangered by electric shocks. If the product has no power switch for disconnection from the AC supply, the plug of the connecting cable is regarded as the disconnecting device. In such cases, it must be ensured that the power plug is easily reachable and accessible at all times. If the VMC‑1 is integrated in racks or systems, a disconnecting device must be provided at the system level. Before connecting peripheral devices, switch off the power supply of the VMC‑1. The system has to be grounded as well. Otherwise the VMC‑1 and/or connected devices may be damaged. Electrical installation only should be done by qualified personal. Make certain that persons who install or operate the VMC‑1 are physically, mentally and emotionally fit enough. Non observance of the safety instructions can result in personal injury, death or property damage. It is the responsibility of the employer to select suitable personnel for installing and operating the VMC‑1.

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Warning for medical appliances: Do not touch unused interfaces like USB or COM ports and a patient at the same time. Secure unused interfaces with supplied covers. Although the VMC‑1 is resistant against a lot of aggressive chemicals, some of them like acids and others can damage the housing, the seals, display or touch screen. Contact an Olympus representative or an authorized service center for further information. Olympus products are not protected against penetration of water, unless otherwise specified. If this is not taken into account, there exists the danger of electric shock or damage to the product, which can also lead to personal injury. Operate the touch screen only with your fingers, gloves or a special input pen. Hard, sharp, pointed, wooden, metal or plastic devices, pencils, pens, knives or other objects will damage the touch screen. Never shock, hit, overheat, burn, scratch or smash the VMC‑1. This will destroy the VMC‑1 or parts of VMC‑1. Do not insert any objects into the openings in the housing that are not designed for this purpose. Never pour any liquids into the housing. This can cause short circuits inside the products and/or electric shocks, fire or injuries. The administrator password for the used operating system and/or BIOS is very important. The loss of the password can cause data loss or will heavily influence the software installation of your system. Because the administrator password is the main key for your system (access to all data, possibility to change all options … ) it is very important, that only authorized persons will have access to this password. Invalid changes of BIOS settings can make your system useless or will cause data loss and/ or hardware damage. Any damages and/or problems caused through invalid BIOS changes will not be covered by warranty. Warning for medical appliances: Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards (e.g. IEC 950 for data processing equipment and IEC 60601‑1 for medical equipment). Furthermore all configurations shall comply with the valid version of the system standard IEC 60601‑1‑1. Everybody who connects additional equipment to the signal input part or signal output part configures a medical system, and is therefore responsible that the system complies with the requirements of the valid version of the system standard IEC 60601‑1‑1. If in doubt, consult the technical service department or your local representative. The product may be operated only under the operating conditions specified by Olympus. Do not place the VMC‑1 on heat-generating devices such as radiators or fan heaters. The temperature of the environment must not exceed the maximum temperature specified in this manual. Do not place the VMC‑1 inside a closed housing unless this is well ventilated. Be aware that in the event of a fire, toxic substances (gases, liquids, etc.) that may be hazardous to your health may escape from VMC‑1.

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As with all industrially manufactured goods, the use of substances that induce an allergic reaction (e.g. nickel, aluminium) cannot be generally excluded. If you develop an allergic reaction (such as a skin rash, frequent sneezing, red eyes or respiratory difficulties), consult a physician immediately to determine the cause. Never use the product under conditions in which condensation has formed or can form in or on the product, e.g. if the product was moved from a cold to a warm environment. The user is responsible for securely fastening the VMC‑1 to or on the means of transport and for observing the safety regulations of the means of transport. Noncompliance can result in personal injury or material damage. Do not place and/or mount the VMC‑1 on cards, trolleys, surfaces, vehicles, cabinets or tables that for reasons of weight or stability are unsuitable for this purpose. Adequately secure the VMC‑1 to prevent injuries or other damage in the event of unexpected movement and impacts. Contact an Olympus representative or an authorized service for more information about suitable mountings and fastenings. Be aware of the weight of the product. Be careful when moving it, otherwise you may injure your back or other parts of your body.

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3 Upon Delivery Make sure that the shipping case contains all of the items listed below. Contact an Olympus representative or an authorized service center if any items are missing or damaged and do not proceed with the installation. Contents WD11010A -- VMC‑1 -- Connector cable -- Galvanic isolator for the network interface -- Instructions for use -- ENDOBASE license

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4 Product Description 4.1 VMC‑1 The documentation system VMC‑1 is equipped with a projected capacitive touch screen with capacitive system keys in the front glass.

1) USB 2.0 port 2) Capacitive system keys 4.1.1 Capacative System Keys

1) Brightness control 2) Backlight Switches on/off the backlight of the touch screen. 3) Cleaning Disables/enables the touch function. 4) Lock PC Locks the VMC‑1. 5) Help Simulates the function key F1 to open the help. 6) Menu Simulates a mouse right click to open a context menu. 7) Power Switches on/off the VMC‑1.

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After providing power to the system, the capacitive keys need about 7 seconds before recognizing finger taps.

4.2 Switching On/Off the VMC-1 Switching On •• To switch on the VMC‑1, press the power button in the bottom right corner of the VMC‑1 for 3 seconds. Switching Off •• To shut down the VMC‑1, press the power button in the bottom right corner of the VMC‑1 for 3 seconds. •• To switch off the VMC‑1 immediately, press the power button in the bottom right corner of the VMC‑1 for 10 seconds.

4.3 Interfaces for attachable Devices The interfaces for attachable devices are located at the rear panel of the VMC‑1.

1) AC in 2) COM1 (galvanic isolated RS232 interface) 3) Firewire IEEE 1394a 4) MIC IN audio jack 5) 2x USB 2.0 6) 2x USB 3.0 7) HDMI 8) HDMI 9) Potential equalization 10) Serial COM port (standard RS232 interface) 11) VGA 12) GbE LAN 13) GbE LAN 14) LINE OUT audio jack 15) Digital video out (SDI out) 16) Digital video out (SDI out) 17) Digital video in (SDI in) 18) Analog video out 19) COM2 (galvanic isolated RS232 interface)

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Warning for medical appliances: Accessory equipment connected to the analogue and digital interfaces must be certified according to the respective IEC standards (e.g. IEC 60950 for data processing equipment and IEC 60601‑1 for medical equipment). Furthermore all configurations shall comply with the valid version of the system standard IEC 60601‑1‑1. Everybody who connects additional equipment to the signal input part or signal output part configures a medical system, and is therefore responsible that the system complies with the requirements of the valid version of the system standard IEC 60601‑1‑1. If in doubt, consult the technical service department or your local representative.

4.4 Symbols This section gives an explanation for each symbol used on the product and on the packing of the product. Marks a safety alert Consult instructions for use CE mark to confirm, that this device meets all appropriate regulations and directives In accordance with European Directive 2002/96/EC on Waste Electrical and Electronic Equipment, this symbol indicates that the product must not be disposed of as unsorted municipal waste, but should be collected separately.Refer to your local Olympus distributor for return and/or collection systems available in your country. Serial number

4.5 Warranty Any warranty claims towards Olympus are forfeited if the user or unauthorized persons attempt repair or modification of the product. No warranty is provided for any damage due to misuse of the product.

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5 Repair and Disposal 5.1 Repair Authorized service center Repairs may only be performed by qualified servicing personnel that has been authorized by Olympus. Contact an Olympus representative or an authorized service center for repair and warranty information. Warranty claims Any warranty claims towards Olympus are forfeited if the user or unauthorized persons attempt repair or modification of the product. Service centers do not accept warranty claims for damage caused by inadequate packaging. Shipment Use the original cardboard packing for the transport of the product. If this is not possible, wrap each component individually in sufficient paper or sheets of foamed material and place them in a cardboard box. Remove all patient data from the device. As a general safety precaution the VMC‑1 must be cleaned an disinfected before returning for service, repair, inspection or disposal. Contaminated items must not be returned without prior, written agreement.

5.2 Disposal When disposing of the product or any of its components, follow all applicable national and local laws and guidelines.

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6 Cleaning and Disinfecting Electric shock hazard. Before cleaning the VMC‑1, disconnect the power cord to the device. Electric shock hazard. Do not autoclave the VMC‑1. The device and accessories are not autoclaveable. Never wet the VMC‑1 or immerse it in fluid of any kind. Never allow liquid to enter the device. Olympus recommends product cleaning and disinfecting according to the guidelines and specifications of the German Robert Koch-Institute (RKI). These guidelines apply to the VMC‑1 only. For cables, sensors and other peripheral items, follow the cleaning instructions in the instructions for use that accompany these accessories. The following germicidal products are approved disinfectants to disinfect the VMC‑1, especially for the glass front: -- Incidin plus -- Skinmansoft -- Cutasept G. & F. -- Sterilium -- Aseptoman Use a spray applicator to apply any of the approved liquids from the list and use a soft lint free cloth to clean the screen. Follow the guidelines of the manufacturer of the cleaning agent. If you use a product or method other than those recommended above, you have to document the use of other disinfectants accordingly in the cleaning protocol. Contact Olympus for the approval of further germicides and detergents. Disinfect according to the procedures of your facility and local regulations.

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7 Technical Data VMC‑1 System

Processor

Intel® Core™ i5‑2510E

Chipset

Intel® QM67

Memory

204-pin 1333/1066 MHz dual-channel DDR3 SO-DIMMs (4GB)

BIOS

UEFI BIOS

Video

Intel® HD Graphics

Supported API

DirectX 10.1, OpenGL 3.0

Display resolution

max. 2560 x 1600

Graphic memory

max. 1.7 GB

Audio

Realtek ALC888 HD 7.1 channel audio codec

Network controller

1x Intel® 82579 PHY GbE LAN controller with iAMT 7.0 supported 1x Intel® 82583V GbE LAN

Super I/O

Fintek F81865

Watchdog

1~255 sec. system reset

Operating System

Windows 7

Power supply

Power supply

Integrated fanless 150 W power supply

Display

Integrated TFT-LCD

21.5": 1920 x 1080 pixel resolution, 16.7 mio. colors, brightness 250Cd, contrast ration 1000:1, typical response time 5ms, viewing angle H/V: 178°/170°

Touch screen

Multi-touch

Projected capacitive touch screen with multi touch function (2 points)

Mass storage

Hard disk

2.5" S-ATA hard disk with 500 GB

Interfaces

COM ports

1x RS232 2x RS232 (electrically isolated)

USB ports

3x USB 2.0, 2x USB 3.0

Keyboard/mouse

Via USB interface

Monitor

1x VGA 2x HDMI

Network

RJ45

1x GbE LAN with iAMT 7.0 1x GbE LAN

Media interface

Mic in

Mic in for microphone connection (e.g. headset)

Line out

Line out for speaker connection

System keys

Power on/off (green illuminated)

Capacitive keys

Backlight brighter Backlight darker Backlight on/off enable / disable keys

Cleaning: Disables/enables the touch function (when disabled, illumination lights brighter). Lock PC: Locks the VMC‑1. Help: Simulates the function key F1 to open the help. Menu: Simulates a mouse right click to open a context menu.

Housing

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Device

Complete smooth, hygienic anti-reflection glass with touch and back part of steady stainless steel without cooling ribs.

Mounting

VESA 100/200 standard

Weight

approx. 13.2 kg

VMC‑1 Certificates

CE certificate of conformity Proofed on:

EN60601-1:2006

Medical Directive 93/42/EEC + 2007/47/EC

EN60601-1-2:2007

7.1 Electrical specifications Input range:... 100 to 240 V~ Max. input current:...1.0 to 0.5 A Frequency:...50 to 60 Hz Main Fuse:... T 1.25 A H/250 V~

7.2 Ambient Conditions 7.2.1 Operating Conditions Ambient temperature... 0 to 35 °C (32 to 95 °F) Relative humidity...10 to 90 % 7.2.2 Storage Conditions Temperature... -10 to 60 °C (14 to 140 °F) Relative humidity...5 to 95% (non condensing) 7.2.3 Transport Conditions Temperature... -10 to 60 °C (14 to 140 °F) Relative humidity...5 to 95% (non condensing)

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8 Electromagnetic Compatibility Precautionary Measures Electromedical devices are subject to special precautionary measures concerning electromagnetic compatibility (EMC). This device is to be used only for the purposes described in the instruction manual and has to be installed, set up, and operated in compliance with the EMC guidelines. Impact of Mobile and Portable RF Communication Devices The emission of high frequency energy by mobile communication devices may impact the function of the electromedical device. Operating such mobile communication devices (e.g. cell phones, GSM phones) in the proximity of the electromedical device is prohibited. Electrical Connections Electrical connections bearing this warning symbol may not be touched. Connections between such plugs and sockets may not be established without first implementing ESD precautionary measures. ESD Precautionary Measures The following are ESD precautionary measures: •• Connect all electrical equipment to be connected to the device to a potential equalisation system (via PE). •• Use only the equipment and accessories mentioned in the instruction manual. The staff have to be informed about and trained in ESD precautionary measures. Guidance and manufacturer´s declaration – electromagnetic emission The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Emissions test

Compliance

Electromagnetic environment – guidance

RF emissions CISPR 11

Group 1

This device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Class A

This device is suitable for use in all facilities including those in residential areas and those directly connected to a public supply network that also supplies buildings used for residential purposes.

Voltage fluctuations/flicker emissions IEC 61000-3-3

In compliance

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Guidelines and manufacturer’s Declaration – electromagnetic immunity This device is intended for use in the electromagnetic environment specified below. The customer or the user of this device should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment – guidance

Electrostatic discharge (ESD) IEC 61000-4-2

± 6 kV contact ± 8 kV air

± 6 kV contact ± 8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/burst IEC 61000-4-4

± 2 kV for power supply lines ± 1 kV for input/output lines

± 2 kV for power supply lines ± 1 kV for input/output lines

Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC 61000‑4‑5

± 1 kV line(s) to line(s) ± 2 kV line(s) to earth

± 1 kV line(s) to line(s) ± 2 kV line(s) to earth

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000‑4‑11

< 5% UT* (> 95% dip in UT) for 0.5 cycle

< 5% UT* (> 95% dip in UT) for 0.5 cycle

40% UT (60% dip in UT) for 5 cycles

40% UT (60% dip in UT) for 5 cycles

70% UT (30% dip in UT) for 25 cycles

70% UT (30% dip in UT) for 25 cycles

Mains power quality should be that of a typical commercial or hospital environment. If the user of this device requires continuous operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply or a battery.

< 5% UT (> 95% dip in UT) for 5 s

< 5% UT (> 95% dip in UT) for 5 s

3 A/m

3 A/m

Power frequency (50/60 Hz) magnetic field IEC 61000‑4‑8

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

*Note: UT is the a.c. mains voltage prior to application of the test level.

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Guidance and manufacturer’s declaration – electromagnetic immunity This device is intended for use in the electromagnetic environment specified below. The customer or user of this device should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment – guidance

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 Vrms

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of this device, including cables), than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.17 √ P d = 1.17 √ P 80 MHz to 800 MHz d = 2.33 √ P 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts [W] according to the transmitter manufacturer and d is the recommended separation distance in meters [m]. Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which this device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the device.

a

b

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Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and this device This device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of this device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and this device as recommended below, according to the maximum output power of the communications equipment. Rated output of the transmitter [W]

Separation distance according to frequency of the transmitter m 150 kHz to 80 MHz d = 1.17 √ P

80 MHz to 800 MHz d = 1.17 √ P

800 MHz to 2.5 GHz d = 2.33 √ P

0.01

0.02

0.02

0.04

0.1

0.06

0.06

0.11

1

0.18

0.18

0.35

10

0.55

0.55

1.11

100

1.75

1.75

3.50

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres [m] can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts [W] according to the transmitter manufacturer.

Note 1: For 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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9 Maintenance 9.1 Inspection •• Check the connection to the power supply. •• Regularly check the function of the VMC‑1.

9.2 Replacing the Fuse Remove fuse holder •• Remove the power cable from the VMC‑1. •• Remove the fuse holders next to the power connector at the rear panel of the VMC‑1. •• Replace the fuses (T 1.25 A H/250 V~). Reinsert fuse holder •• Reinsert the fuse holder. •• Reconnect the power cable. •• Switch on the VMC‑1.

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