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Summary of Contents for Brainlab Buzz 2.0
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BUZZ Version 2.0 System and Technical User Guide Revision 1.2 Date of issue: 2020-05-18 (ISO 8601) Copyright 2020, Brainlab AG Germany. All rights reserved.
TABLE OF CONTENTS TABLE OF CONTENTS 1 GENERAL INFORMATION .....................5 1.1 Contact Data ............................5 1.2 Legal Information ..........................6 1.3 Symbols ..............................8 1.3.1 Symbols Used in This Guide .......................8 1.4 Using the System ..........................11 1.5 Software Environment ........................13 1.6 Training and Documentation ......................19 2 SYSTEM OVERVIEW ......................21...
Japan Fax: +81 3 3769 6901 Service Life Brainlab provides eight years of service for platforms. During this period of time, spare parts as well as field support are offered. Feedback Despite careful review, this user guide may contain errors. Please contact us at user.guides@brainlab.com if you have improvement suggestions.
This product may be covered by one or more patents or pending patent applications. For details, see: www.brainlab.com/patent. CE Label The CE label indicates that the Brainlab product complies with the General Safety and Performance Requirements of European Regulation 2017/745, the Medical Device Regulation (“MDR”).
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US federal law restricts this device to sale by or on the order of a physician. Report Incidents Related to This Product You are required to report any serious incident that may have occurred related to this product to Brainlab, and if within Europe, to your corresponding national competent authority for medical devices. FCC Compliance Buzz has been tested and found to comply with the limits for a Class A digital device, according to Part 15 of the FCC rules.
Symbols Symbols 1.3.1 Symbols Used in This Guide Warnings Warning Warnings are indicated by triangular warning symbols. They contain safety-critical information regarding possible injury, death or other serious consequences associated with equipment misuse. Cautions Cautions are indicated by circular caution symbols. They contain safety-critical information regarding possible problems with the device.
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GENERAL INFORMATION Symbol Explanation Quantity of products in packaging Batch number Serial number Article number Date of manufacture Manufacturer ETL/Intertek approval Radio 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.
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Symbols Symbol Explanation Handle with care This side up Do not stack more than n Contains renewable materials System and Technical User Guide Rev. 1.2 Buzz Ver. 2.0...
Using the System Intended Use and Indications for Use/Intended Purpose Buzz 2.0 is intended for use as a stationary computing platform hosting one or more software applications. Buzz 2.0 facilitates the display and exchange of, as well as the interaction with data.
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Using the System Known Contraindications Buzz does not have a direct therapeutic impact and hence no side effects or contraindications are aligned with its use. Careful Hardware Handling Only trained users are allowed to use Buzz. Plausibility Review Warning Before patient treatment, review the plausibility of all information input to and output from the device.
GENERAL INFORMATION Software Environment Bill of Materials of Integrated Third-Party Software Buzz 2.0 Computer (Article Number 15835A): • Windows 10 IoT Enterprise 2016 LTSB • Chipset driver - SPSR 10.1.2.10 • FUJ02E3 driver - 1.30.3.0 • Rapid Storage driver - RST SATA sSATA 4.3.0.1198 •...
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If you want the data to be removed from the device, please contact Brainlab support. If the device needs to be shipped to Brainlab for repairs, delete patient data or the mass storage media will be removed by Brainlab support and returned.
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GENERAL INFORMATION Address: www.brainlab.com/updates Password: WindowsUpdates!89 Emergency Access to the Platform NOTE: Perform this configuration action only if requested by the customer. It should be left unchanged otherwise. To create an additional user account for emergency access to the system: Step Switch on the system and login as Administrator.
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Software Environment Step Enter the user name (does not have to match the screenshot below) and ensure all the checkboxes are unchecked. Enter a password and confirm the password. Click Create. System and Technical User Guide Rev. 1.2 Buzz Ver. 2.0...
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Add user to the group (as described above). An Administrator must have a password. Automatic Driver Update Do not update drivers on Brainlab platforms either manually or by using Windows update functionality. System and Technical User Guide Rev. 1.2 Buzz Ver. 2.0...
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Software Environment Cybersecurity Use Environment Cybersecurity considerations were made in accordance with the nature of the device, including the device type and the following use environments of the platform(s) during its lifetime. The following common best practice security controls (“security hygiene”) in the use environment are expected to be followed.
Detailed instructions for the effective and correct implementation of Site Planning Manual Buzz. NOTE: Available user guides vary depending on the Brainlab product. If you have questions regarding the user guides you received, contact Brainlab support. System and Technical User Guide Rev. 1.2 Buzz Ver. 2.0...
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Training and Documentation System and Technical User Guide Rev. 1.2 Buzz Ver. 2.0...
Buzz is a platform for the integration of devices and for the distribution of video signals and multimedia content. It is intended to be used for communication between compatible Brainlab devices. It provides centralized access for managing video data, medical images and patient data.
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System Components Buzz On-Wall Buzz On-Wall can be mounted with all components attached to each other in a central location. The computer can be mounted up to 2.5 m away from the touch display when connected using copper cables. When optical transfer lines are used to connect computer and touch display, the distance can be up to 100 m.
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SYSTEM OVERVIEW ④ Figure 3 When using the Buzz In-Wall setup (only), you can use the Digital OR Computer For Barco Integration ④. It must always be placed in a non-medical, technical room outside the OR/patient environment. All connections between the computer and Buzz 2 components in the operating room are galvanically separated.
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System Components System Connections on page 37 System and Technical User Guide Rev. 1.2 Buzz Ver. 2.0...
SYSTEM OVERVIEW 2.1.2 Ventilation Ensuring Ventilation Do not cover or block ventilation openings. Otherwise the system could overheat and be seriously damaged. Buzz On-Wall Ventilation Openings Ventilation openings are located on the top, bottom and sides of the system as marked below. Figure 5 NOTE: If the computer is wall mounted the "wave"...
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Ventilation Buzz In-Wall Ventilation Openings Ventilation openings are located as marked below. ① ② Figure 7 Component ① Computer connection panel ② 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 openings.
Space for Servicing the System The Buzz touch display can be flipped down 90° when Brainlab services the system. Ensure that there is sufficient space in front of and below the system and no permanent objects are installed there.
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OR Setup HF Surgery Warning Buzz has not been tested in HF Surgery environment. Environmental Restrictions Warning Buzz is not suitable 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. ③...
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SYSTEM OVERVIEW Example Buzz In-Wall This example shows an installed Buzz In-Wall with additional touch display. ① ② ④ ③ Figure 10 Component ① Touch display ② Computer (compatible with 19” rack) ③ Patient environment (inside line) ④ Additional touch displays System and Technical User Guide Rev.
Proper System Handling Proper System Handling Proper Handling Warning Prior to surgery, test the device to ensure that it is functioning properly. Visually inspect the device and all cables for damage. Start the system, ensure that the system boots up correctly and patient data has been loaded correctly.
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SYSTEM OVERVIEW Laser Safety The equipment contains a DVD recorder: This unit meets Class I laser criteria of FDA Laser Notice No. 50 and IEC 60825-1. Do not try to open enclosures of devices equipped with a laser (e.g., optical disk drives). There are no user-serviceable components inside.
• If the power plug is accessible unplug the power plug from the socket. • If an external mains switch is installed, turn off the mains switch. • If the power plug is not accessible and no mains switch is installed, please contact Brainlab support to disconnect the power plug.
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• If the power plug is accessible unplug the power plug from the socket. • If an external mains switch is installed, turn off the mains switch. • If the power plug is not accessible and no mains switch is installed, please contact Brainlab support to disconnect the power plug.
Figure 13 This message indicates that the Buzz touch display is not receiving a video signal. Check that the computer is switched on and booted. If this does not solve the problem, contact Brainlab support. Booting Screen Figure 14 Status LED: Feature Panel...
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SYSTEM OVERVIEW Status LED: Computer ① ② Figure 16 Color Status Explanation Mains Power LED ① Mains power and system is turned off. Power Switch LED ② Mains Power LED Blue Solid Mains power on (system standby). Power Switch LED Mains Power LED Blue Solid...
Touch Display Interaction 2.4.3 Touch Display Interaction Appropriate Use Do not use sharp tools on the touch display. Do not attach labels or sticky notes to the touch display or its surrounding black frame, 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.
Read all user guide documentation carefully before connecting any equipment to Buzz. Mains Power Cables The mains power cables may only be exchanged by Brainlab or authorized service personnel. Do not tug or pull at cables when establishing or opening a connection, but always pull at the connector.
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System Connections • DVD+R • DVD+R DL • DVD+RW • DVD-RAM The following CD/DVD types can be written 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.
The WLAN module included in this product cannot be accessed by the end users. The FCC ID and IC ID of the WLAN module can be found on the label. Please contact Brainlab support in case of any related questions.
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SYSTEM OVERVIEW Scan USB flash drives with an antivirus software before connecting them to the system. Feature Panel ① ② ⑤ ④ ③ Figure 18 Component ① USB 2.0 ports ② Speaker (Mono) ③ Video camera ④ Power Button with status LED ⑤...
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④ Warning The USB Type B connector at the MCU User Panel is explicitly for connect- ing the Brainlab Microscope Cable. Connecting other devices to this inter- face might damage the devices or the MCU. ⑤ 2 x DVI Video Inputs Power connections for transfer line components ⑥...
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Brainlab support Power connections for transfer line components 4 x 5 V DC / 0.5 A each ⑩ Brainlab support NOTE: Only connect equipment specified by Brainlab to the DC output. System and Technical User Guide Rev. 1.2 Buzz Ver. 2.0...
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NOTE: The Mains Switch, Mains Power Inlet and Potential Equalization 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 used for internal system communication.
SYSTEM OVERVIEW 2.5.3 Potential Equalization Connection General Information The function of the potential equalization conductor is: • To equalize potentials between different metal parts that can be touched simultaneously. • To reduce differences of potential that can occur between medical electrical devices and conductive parts of other objects during operation.
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Potential Equalization Connection System and Technical User Guide Rev. 1.2 Buzz Ver. 2.0...
CLEANING AND DISINFECTION CLEANING AND DISINFECTION Cleaning Instructions 3.1.1 Overview Before You Begin Ensure that the system is fully shut down before beginning cleaning. No Automatic Disinfection Do not use automatic cleaning and disinfection procedures for Buzz components. No Sterilization Do not sterilize Buzz components.
Cleaning Intervals Clean the device after each use. The frequency of cleaning depends on how frequently the system is used. Brainlab cannot give general recommendations on cleaning intervals. This is within the user’s responsibility. Post-Cleaning After cleaning, ensure that the all Buzz components are completely dry before using the system.
Do not use in wet areas or locations where liquids could enter the system. If liquids have entered the system, do not operate the device. Disconnect it from the mains power supply and contact Brainlab support. System and Technical User Guide Rev. 1.2 Buzz Ver. 2.0...
Environmental Requirements Environmental Requirements 4.2.1 Environmental Conditions Local Restrictions • Store and operate system in locations that are protected against moisture, wind, sunlight, dust, salinity and sulfur. • Do not store system in the close vicinity of chemical products or gas. •...
COMPLIANCES AND SPECIFICATIONS System Specifications 4.3.1 Physical Characteristics Buzz On-Wall Buzz On-Wall Computer and Touch Additional Touch Display Display side by side On-Wall Height 667 mm 667 mm Width 1866 mm 1054 mm Depth 184 mm 103 mm Weight 64 kg 30 kg Buzz On-Wall Computer flexible set- Buzz On-Wall Touch Display...
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System Specifications Computer Weight 18 kg (~40 lbs) (plus weight of rack mount) NOTE: The above dimensions are based on horizontal placement of the computer. Digital OR Computer For Barco Integration without Rack Mount Computer Height 186 mm (7.3 inch) Width 430 mm (16.9 inch) Depth...
NOTE: The customer must take ISO / IEC 11801 requirements into account. Connecting the device to a hospital network is creating a ME system according to IEC 60601-1. Brainlab recommends that the hospital network components are compliant with an adequate IEC standard (IEC 60601-1 Clause 7.9.2.9).
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COMPLIANCES AND SPECIFICATIONS Potential Hazards of Network Failure The following hazardous situations could result if the hospital network or data coupling does not meet the requirements listed in this section: • Patient treated incorrectly due to: - Network failure during patient data transfer - Malware (e.g., viruses) causing PC to miscalculate data •...
Compliances Compliances 4.4.1 Electromagnetic Emissions Electromagnetic Environment Buzz systems are intended for use in the electromagnetic environment specified in the table below. The user is responsible for ensuring that the systems are used in such an environment. Electromagnetic Emissions Declaration Buzz is intended for use in professional healthcare facility environment only.
COMPLIANCES AND SPECIFICATIONS 4.4.2 General Electromagnetic Immunity Electromagnetic Environment Buzz systems are intended for use in the electromagnetic environment specified in the following sections. The user is responsible for ensuring that the systems are used in such an environment. Electromagnetic Immunity Declaration The tables in the following sections provide guidance according to the manufacturer’s electromagnetic immunity declaration.
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General Electromagnetic Immunity Immunity test Standard IEC 60601-1-2 test Compliance level level ; 250/300 cy- Voltage interruptions 0% U ; 250/300 cycle a) E.g. 10/12 means 10 periods at 50 Hz or 12 periods at 60 Hz. An exemption has been used and the equipment has not been tested for radiated RF immunity over the entire frequency range 80 MHz to 6000 MHz.
COMPLIANCES AND SPECIFICATIONS 4.4.3 RF Communication Equipment Electromagetic Environment Portable and mobile RF communications equipment can affect the systems. Buzz is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. Buzz users can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and Buzz as recommended below, according to the maximum output power of the communications equipment.
Buzz cables that have been tested for emission and immunity conformity: Cables Specification Power cable Provided by Brainlab Potential Equaliza- Provided by Brainlab (optional) tion Cable S-Video 2 x BNC coax cable, shielded, terminated, 75 Ohm CVBS / SDI 1 x BNC coax cable, shielded, terminated, 75 Ohm 1 x DVI-D 24 AWG, shielded, terminated, 100 Ohm 1 x DisplayPort 1.2 cable 30 AWG, shielded, terminated, 100 Ohm...
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When removing the connector, press Feature Panel the latch, then pull plug out. Only connect microscopes via a Brainlab microscope cable. Plug in the cable by connecting all connectors (DVI-I, USB, CVBS) to the corresponding port.
Buzz Computer: Supported Input Resolutions The table below specifies the supported input resolutions for each input available on Buzz. Signals outside of the specified resolutions may not be supported. For more information on input resolution contact Brainlab support. Imaging Input Color Coding...
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Graphic Card 3D Output The graphic card delivers a progressive single stream signal. The 3D content is created by Brainlab software (additional software may be required). An external display must support 3D line- by-line technology to display the 3D content correctly.
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Supported Resolutions Imaging Input Connectors Signal Type Impedance (Ohm) RGB/YCbCr Digital OR Computer For Barco Integration Input Connectors Digital OR Computer For Barco Integration has no direct video inputs. It offers connectivity to the Barco Nexxis video routing network: • Imaging Input: Barco Nexxis •...
ELECTRICAL SAFETY ELECTRICAL SAFETY Introduction 5.1.1 Buzz System Buzz Classification Buzz is classified as Class I equipment according to IEC 60601-1 and must be tested accordingly. Buzz On-Wall and Buzz In-Wall are medical electrical systems (ME SYSTEM). Classification Definition Classification regarding protection against electric shock. Refers to electrical equipment in which protection against electric shock does Class I not rely on basic insulation only, but which includes an additional safety pre-...
Brainlab must be informed immediately in writing if equipment is deemed unsafe. Inspections by Brainlab Support • If a suitably qualified person is not available at the customer site, Brainlab support will perform this inspection for a set fee. • If you require a Brainlab support specialist, contact Brainlab support.
Testing Precautions ME SYSTEM test steps must be performed as described below. • The described test only covers the Brainlab Buzz equipment and not connected equipment. • In addition, follow the directions given by the manufacturer of the connected device.
• Are glass surfaces are broken? • Are all Buzz components available? If any damage is detected, place the device out of operation, mark as such and contact Brainlab support. Definition: Resistance between any accessible conductive part that must, for safety...
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ELECTRICAL SAFETY Step Instructions and Conditions Test the equipment leakage current according to IEC 62353:2014 Chapter 5.3.3.2.3 using the "differential method" with the following additional con- ditions: • Measurements are performed at mains voltage Equipment leakage current • Measurements are performed in both positions of the mains plug, if possible When measuring in the various positions of the mains plug, document the higher value...
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Recurrent Tests Test Step Normal Condition Single Fault Condi- Test Result tion Protective earth resistance Equipment leakage current Touch current Device under test: Buzz 2 Serial number: Serial number of measuring device: Calibration valid through (date): Test performed (date): Related Links System Messages on page 34 Performing Tests on page 71 Equipment Leakage Current on page 72...
Some test points may not be applicable for your Buzz variant. If a test does not pass, device must be repaired by Brainlab support. After repair, repeat the entire electrical safety test from the beginning.
Equipment Leakage Current 5.3.2 Equipment Leakage Current General Information Connect the measurement tip of your measuring device with the conductive parts shown in the table below and measure the equipment leakage current. Some test points may not be applicable for your Buzz variant. Equipment Leakage Point Tested Measured Val-...
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ELECTRICAL SAFETY Point Tested Measured Val- Test Passed? Additional Touch 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 System and Technical User Guide Rev. 1.2 Buzz Ver. 2.0...
Touch Current 5.3.3 Touch Current General Information Connect the measurement tip of your measuring device with the conductive parts shown in the table below and measure the touch current. Some test points may not be applicable for your Buzz variant. Touch Current The touch current test for ME SYSTEM may repeat some of the measurement points as defined for equipment leakage current.
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ELECTRICAL SAFETY Point Tested Measured Val- 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 System and Technical User Guide Rev. 1.2 Buzz Ver. 2.0...
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Touch Current System and Technical User Guide Rev. 1.2 Buzz Ver. 2.0...
Only Brainlab and/or authorized partners 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 Brainlab or trained authorized technicians.
Arrangement Service Contract Available Annual Inspection 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. System and Technical User Guide Rev. 1.2 Buzz Ver. 2.0...
• Informs Brainlab immediately in writing if equipment is deemed unsafe Inspections by Brainlab Personnel If a suitably qualified person is not available at customer site, Brainlab support specialists carry out this inspection for a set fee. If you require a Brainlab support specialist, contact Brainlab support.
Safety Inspection Measurements 6.1.4 Safety Inspection Measurements Tests to be Performed The electrical safety test must comprise all steps listed in the electrical safety form. In addition to the electrical safety form, the safety inspection also comprises the further inspections described under Maintenance.
How to Respond to Damage or Failure Step Turn off system. Contact Brainlab support. Attach a notice such as “DO NOT USE” to equipment to prevent it from being used inad- vertently. If you continue to use equipment that has been found to be defective during an inspection, you risk causing injury to the patient and user.
Return Instructions Reporting Damaged Equipment Any defective components should be immediately reported to Brainlab support. When you contact Brainlab support regarding a defect, you are asked for: • System serial number on type plate • A description of the problem...
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INDEX INDEX annual inspection............... 78 recurrent test guidelines................67 returning equipment addresses................82 RF communications equipment..........59 cables..................60 CD compatibility................. 37 cleaning disinfectants................48 compatibility safe disposal................6 disinfectants................48 safety..................30 connection panel................ 43 safety inspection.................79 storage conditions..............50 support numbers................5 sustainability.................6 disinfectants................
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Questions and answers