Brainlab Buzz 2.0 System And Technical User Manual Download Page 78

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6.1.2

Annual Inspection

Arrangement

Service Contract Available

Annual Inspection

Yes

Automatically performed by Brainlab

Contact Brainlab support for arrangement

Scope

This inspection covers all components and functions as well as the items specified on the safety
inspection form.

Annual Inspection

System and Technical User Guide Rev. 1.2 Buzz Ver. 2.0

Summary of Contents for Buzz 2.0

Page 2: ......

Page 3: ...Proper System Handling 30 2 4 Using the System 32 2 4 1 Turning Buzz On and Off 32 2 4 2 System Messages 34 2 4 3 Touch Display Interaction 36 2 5 System Connections 37 2 5 1 Overview 37 2 5 2 Third...

Page 4: ...1 Introduction 65 5 1 1 Buzz System 65 5 2 Test Requirements 66 5 2 1 Overview 66 5 2 2 Testing Overview 67 5 2 3 Recurrent Tests 68 5 3 Performing Tests 71 5 3 1 Protective Earth Resistance 71 5 3 2...

Page 5: ...900 649 115 France and French speaking regions Tel 33 800 676 030 Africa Asia Australia Europe Tel 49 89 991568 1044 Fax 49 89 991568 5811 Japan Tel 81 3 3769 6900 Fax 81 3 3769 6901 Service Life Brai...

Page 6: ...017 745 the Medical Device Regulation MDR Buzz is a Class I product according to the rules established by the MDR NOTE The validity of the CE label can only be confirmed for products manufac tured by...

Page 7: ...ent This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications Operat...

Page 8: ...damage to device or damage to property Notes NOTE Notes are formatted in italic type and indicate additional useful hints Symbols on Hardware Components The below symbols may be found on the system S...

Page 9: ...device Risk of electrical shock Class I Laser Risk of injury due to laser radiation Power button Consult the operating instructions Follow the instructions for use U S federal law restricts this devi...

Page 10: ...Symbol Explanation Handle with care This side up Do not stack more than n Contains renewable materials Symbols 10 System and Technical User Guide Rev 1 2 Buzz Ver 2 0...

Page 11: ...on and set up prior to use Non sterile usage of videos images and data Shut down and tidying of equipment after surgery A more detailed user profile for the clinical team may depend on the application...

Page 12: ...atient treatment review the plausibility of all information input to and output from the device Diagnostic Imaging Warning The system has not been tested for diagnostic image quality and may not provi...

Page 13: ...Intel Management Engine 11 6 0 1042 Nvidia Driver 22 21 13 8541 Realtek audio 6 0 1 8192 Barco Drivers FrGrabber 7 51 32 633 Barco Drivers NIC 7 51 40 664 FTDI driver 2 12 16 0 ESD CAN 6 1 2609 0 IT...

Page 14: ...ust be verified by a Brainlab service engineer after the first antivirus software installation Be aware that some malware protection software e g virus scanner settings can negatively affect system pe...

Page 15: ...anged otherwise To create an additional user account for emergency access to the system Step 1 Switch on the system and login as Administrator 2 Open Computer Management by typing the name in Search u...

Page 16: ...me does not have to match the screenshot below and ensure all the checkboxes are unchecked Enter a password and confirm the password 5 Click Create Software Environment 16 System and Technical User Gu...

Page 17: ...ure a Standard User Account To install Windows security updates a user must be a member of the group Administrators Add user to the group as described above An Administrator must have a password Autom...

Page 18: ...ation services and applications Network access controls such as segmentation to limit medical device communication General patch management practices that ensure timely security patch updates on adjac...

Page 19: ...prolongation is acceptable for the respective patient and treatment Intended Audience This user guide is intended for doctors and hospital staff Reading User Guides This guide describes complex medic...

Page 20: ...Training and Documentation 20 System and Technical User Guide Rev 1 2 Buzz Ver 2 0...

Page 21: ...quently Used Functions The following are defined as the most frequently used Buzz hardware functions Switching the device on off Interacting with Brainlab software via the touch display Transferring p...

Page 22: ...trol room rack for example Figure 1 No Component User panel behind cover Computer including cover Touch display Feature panel NOTE The cables connecting the computer to the touch display are visible w...

Page 23: ...y and up to three additional touch displays Figure 4 No Component Additional touch display NOTE The Buzz In Wall variant is shown in this example NOTE Depending on your configuration additional touch...

Page 24: ...System Connections on page 37 System Components 24 System and Technical User Guide Rev 1 2 Buzz Ver 2 0...

Page 25: ...the top bottom and sides of the system as marked below Figure 5 NOTE If the computer is wall mounted the wave cover must always be mounted Ventilation Openings on Additional Touch Display On Wall Vent...

Page 26: ...on panel Computer user panel NOTE There are no exposed ventilation openings on the In Wall touch display NOTE The computer must be installed on the bottom base plate to not block the ventilation openi...

Page 27: ...display be aware that colors may be displayed incorrectly if viewed from an inadequate angle Space for Servicing the System The Buzz touch display can be flipped down 90 when Brainlab services the sys...

Page 28: ...uitable for use in the presence of flammable anesthetic mixtures containing air oxygen or nitrous oxide Example Buzz On Wall This example shows an installed Buzz On Wall system Figure 9 No Component T...

Page 29: ...lled Buzz In Wall with additional touch display Figure 10 No Component Touch display Computer compatible with 19 rack Patient environment inside line Additional touch displays SYSTEM OVERVIEW System a...

Page 30: ...ocks and Impact Protect the device from severe shocks Warning Do not use the system after an abnormal impact e g an earthquake or explosion due to the possibility of fundamental structural damage It i...

Page 31: ...not try to open enclosures of devices equipped with a laser e g optical disk drives There are no user serviceable components inside Do not operate controls make adjustments or perform procedures to t...

Page 32: ...in the software preferred or Press the Power button on the Feature Panel 2 Select Shut down in the software When the system has finished shutting down the power LED switches off NOTE After the system...

Page 33: ...ouch display Step After the computer is completely shut down all additional touch displays will be switched off au tomatically using relay control NOTE The mains power disconnection of Buzz depends on...

Page 34: ...ing Screen Figure 14 Status LED Feature Panel Figure 15 Color Status Explanation Off Off System is turned off standby Green Flashing System is booting Wait until LED is solid before use Solid System i...

Page 35: ...ins Power LED Blue Solid Mains power on system standby Power Switch LED Off Off Mains Power LED Blue Solid System switched on Power Switch LED NOTE For a description of LEDs used by the Digital OR Com...

Page 36: ...as this may disturb the touch functionality Non Sterile Touch Display Use Buzz can be used non sterilely by using fingers to interact with the software Figure 17 No Stroke Type Common Functions Single...

Page 37: ...dently of Buzz e g bypassing Buzz and connecting the signal directly to a monitor Warning Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO stan...

Page 38: ...to CD R CD RW DVD R DVD R DL DVD RW DVD RAM 4 7GB DVD R DVD R DL DVD RW Only insert standard CD DVDs of 120 mm diameter Do not insert irregularly shaped CD DVDs Related Links Introduction on page 65 S...

Page 39: ...onnect IEC compliant devices to the LAN ports Wireless LAN Connections Buzz is compliant with the following CE FCC IC The WLAN module included in this product cannot be accessed by the end users The F...

Page 40: ...100 104 108 112 116 132 136 140 149 153 157 161 165 802 11b g 1 11 Europe 802 11a 36 40 44 48 52 56 60 64 100 104 108 112 116 120 124 128 132 136 140 802 11b g 1 13 Japan 802 11a 36 40 44 48 Known as...

Page 41: ...el The areas encircled on the connection panel contain connection ports of a similar function Multiple third party video connections are possible at the same time NOTE For a description of the front a...

Page 42: ...is inter face might damage the devices or the MCU 2 x DVI Video Inputs Power connections for transfer line components 6 x 5V DC 2A NOTE Only connect equipment specified by Brainlab to the DC output Ne...

Page 43: ...Feature Panel Brainlab support Hospital Network 1 GbE Brainlab support Hospital Network 10 GbE Not in use Brainlab support Audio In Out Microphone In Audio In Audio Out Brainlab support Video Output...

Page 44: ...Pin are not accessible if the Computer is wall mounted The connections 4 11 in the connection panel are only for use by Brainlab support Do not change or add any connections to this panel as they are...

Page 45: ...e system is optional When connecting POAG an ME System is created NOTE Not applicable to the Digital OR Computer For Barco Integration which is placed outside the OR in a non medical room How to Conne...

Page 46: ...Potential Equalization Connection 46 System and Technical User Guide Rev 1 2 Buzz Ver 2 0...

Page 47: ...ilization Do not sterilize Buzz components No Liquids Do not spray cleaning solvents or other liquids directly into electrical interfaces or openings e g the air vents Ensure that liquid does not ente...

Page 48: ...nfection wipes or cleaning procedures others than those specified may damage equipment It is suggested to only use disinfectants verified by Brainlab to avoid damaging the system Cleaning Intervals Cl...

Page 49: ...Buzz In Wall with silicone joint IP44 Computer All variants IP20 NOTE The Ingress Protection depends on the Buzz Display installation For more details please refer to the Buzz 2 Site Planning Manual I...

Page 50: ...f the device Altitude Considerations Unless stated otherwise the system is rated for use at an altitude less than 3000 meters Transport or store the system at an altitude less than 6000 meters Adaptio...

Page 51: ...zz In Wall Buzz In Wall Touch Display Additional Touch Display In Wall Height 667 mm 667 mm Width 1189 mm Buzz 42 Touch Display only 1054 mm Depth 103 mm Depth in wall 98 mm 103 mm Depth in wall 98 mm...

Page 52: ...computer Digital OR Computer For Barco Integration without Rack Mount Computer Height 186 mm 7 3 inch Width 430 mm 16 9 inch Depth 481 mm 18 9 inch Weight 18 kg 40 lbs NOTE The above dimensions are ba...

Page 53: ...ements Computer Touch Display Digital OR Computer For Barco Integration Operating Voltage 100 240 V 100 240 V 100 240 V Current 8 4 A 3 5 1 5 A 9 5 4 0 A Frequency 50 60 Hz 50 60 Hz 50 60 Hz Power Con...

Page 54: ...k may introduce new risks and require additional analysis Changes to the hospital network include Changes to the hospital network configuration Connecting additional items to the hospital network Disc...

Page 55: ...listed in this section Patient treated incorrectly due to Network failure during patient data transfer Malware e g viruses causing PC to miscalculate data Unwanted exposure of the patient to anesthet...

Page 56: ...ch CISPR 11 class B is normally required this equipment might not offer adequate protection to radio frequency communication services The user might need to take mitigation measures such as relocating...

Page 57: ...st transi ent burst input a c power port IEC 61000 4 4 2 kV 100 kHz repetition fre quency 2 kV 100 kHz repetition fre quency Electrical fast transi ent burst signal in put output ports 1 kV 100 kHz re...

Page 58: ...Pulse modula tion 18 Hz 1 8 0 3 27 450 430 470 GMRS 460 FRS 460 FM 5 deviation 1 kHz sine 2 0 3 28 710 704 787 LTE Band 13 17 Pulse modula tion 217 Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 900 TETRA...

Page 59: ...800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 d 0 12 d 0 12 d 0 23 0 1 d 0 38 d 0 38 d 0 73 1 d 1 20 d 1 20 d 2 30 10 d 3 79 d 3 79 d 7 27 100 d 12 00 d 12 00 d 23 00 For transmitters rated at a ma...

Page 60: ...ia DVI Copper cables and DVI EO converter may be used for signal in and out Always fix the screws to lock the cable connector NOTE Use high quality DVI copper cable max 5 m to connect DVI Sources or a...

Page 61: ...Port 1 2 ca ble max 5m for 1920 x 1080 60 Hz and max 3 6 m for 3840 x 2160 30 Hz 60 Hz Digital OR Computer For Barco Integration Compatible Cables and Connectors Port Example Handling USB USB ports fo...

Page 62: ...0i 29 97 HD SDI 720p 50 720p 60 1080i 30 1080i 60 1080p 25 1080p 30 3G SDI 1080p 50 1080p 59 94 1080p 60 DVI In 8 Bit RBG DVI I Single Link DVI D 640x480 60Hz 800x600 60Hz 1024x768 60Hz 1280x720 60Hz...

Page 63: ...20x1080 60Hz Microscope 8 Bit RGB DVI I Single Link DVI D 1920x1080 60Hz RGB YCbCr DVI I RGB YCbCr 1024x768 60Hz 1280x1024 60Hz Graphic Card 3D Output The graphic card delivers a progressive single st...

Page 64: ...Impedance n a fiber Supported Video Output Connectors Displays Connectors Signal Type Impedance Ohm Display 1 Display Port DisplayPort 1 2 TheDisplayPort 100 Display 2 Display 3 Display 4 Display 5 DV...

Page 65: ...against electric shock Refers to electrical equipment in which protection against electric shock does not rely on basic insulation only but which includes an additional safety pre caution in that mean...

Page 66: ...ut the use of a tool must be tested individually Additionally the ME SYSTEM must be tested as a whole to avoid that an aging component causes unacceptable values If items of ME EQUIPMENT that are comb...

Page 67: ...void the validity of previous reference values Test Guidelines When performing recurrent tests Perform required test steps in the order defined below All tests must be passed before the device can be...

Page 68: ...he interior are not ac ceptable Verify the condition of all cables shipped used with the device such as Mains power cable Ethernet cable Video cables USB cables Microscope connection cable if applicab...

Page 69: ...l use Power on the device Check if indicator lights are working Start a software application If applicable verify the desired function of the ME SYSTEM Check that Data is displayed on the screen Touch...

Page 70: ...rent Device under test Buzz 2 Serial number Serial number of measuring device Calibration valid through date Test performed date by Related Links System Messages on page 34 Performing Tests on page 71...

Page 71: ...f the display is not accessible from the outside contact Brainlab support Protective Earth Resistance Test Point Tested Measured Val ue Test Passed Buzz Computer only Housing screw close to Mains Powe...

Page 72: ...r your Buzz variant Equipment Leakage Point Tested Measured Val ue Test Passed Computer measurement point on power button Screw of DVI I Out on computer user panel On wall Frame only Right bot tom hol...

Page 73: ...uch Display In Wall Frame overview of potential measurement points In wall Frame measurement de tail On Wall Frame only Additional Touch Display at the paint free hole on the frame ELECTRICAL SAFETY S...

Page 74: ...the measurement points as defined for equipment leakage current Point Tested Measured Val ue Test Passed Screw of DVI I Out on computer user panel Computer measurement point on power button On wall F...

Page 75: ...Test Passed In wall Frame measurement de tail On Wall Frame only Additional Touch Display at the paint free hole on the frame USB Port on the Feature Panel ELECTRICAL SAFETY System and Technical User...

Page 76: ...Touch Current 76 System and Technical User Guide Rev 1 2 Buzz Ver 2 0...

Page 77: ...are allowed to repair the system and equipment Risk of electrical shock There are no user serviceable parts Do not remove any covers All installation servicing and maintenance is to be carried out by...

Page 78: ...n Yes Automatically performed by Brainlab No Contact Brainlab support for arrangement Scope This inspection covers all components and functions as well as the items specified on the safety inspection...

Page 79: ...with product safety information and product instructions and has read and understood the user guides Is up to date with current local regulations regarding industrial and non industrial accident preve...

Page 80: ...d in the electrical safety form In addition to the electrical safety form the safety inspection also comprises the further inspections described under Maintenance Related Links Test Requirements on pa...

Page 81: ...em emits smoke If an LCD panel is damaged e g broken glass do not allow any escaping liquid to come into contact with skin mucous membranes eyes mouth or foodstuffs Do not inhale vapors If contact occ...

Page 82: ...irchheim Heimstetten Germany Brainlab Inc RMA Dept 5 Westbrook Corporate Center Suite 1000 Westchester IL 60154 USA Brainlab KK RMA Dept Tamachi East Bldg 2F 3 2 16 Shibaura Minato ku Tokyo 108 0023 J...

Page 83: ...54 F FCC compliance 7 functional earth resistance 71 G guides 19 I inspections 77 annual 78 safety 79 M manuals 19 O operating conditions 50 P panels connection panel 41 protective earth resistance 7...

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Page 86: ...brainlab com Art No 60920 19EN 60920 19EN...

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