Brainlab CURVE DUAL DISPLAY Technical User Manual

Brainlab CURVE DUAL DISPLAY Technical User Manual

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CURVE DUAL
DISPLAY
CURVE SINGLE
DISPLAY
Version 1.0
Technical User Guide
Revision 1.2
Copyright 2016, Brainlab AG Germany. All rights reserved.

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Summary of Contents for Brainlab CURVE DUAL DISPLAY

  • Page 1 CURVE DUAL DISPLAY CURVE SINGLE DISPLAY Version 1.0 Technical User Guide Revision 1.2 Copyright 2016, Brainlab AG Germany. All rights reserved.
  • Page 3: Table Of Contents

    ................................28 Overview..............................28 UPS Signals...............................29 UPS Battery ...............................30 TROUBLESHOOTING ......................31 Introduction ...............................31 Overview..............................31 Troubleshooting: Monitor Cart ......................32 Possible Occurrences ..........................32 Troubleshooting: Monitor ........................33 Touchscreen Display ..........................33 Touchscreen ..............................34 Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 4 General Electromagnetic Immunity ......................60 Electromagnetic Immunity, Curve System ....................61 RF Communications Equipment.........................63 Tested Cables ............................64 Hospital Network............................65 Power Plugs ..............................66 Overview..............................66 Regional Power Plugs..........................67 USB Flash Drives .............................68 Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 5 TABLE OF CONTENTS Overview..............................68 MAINTENANCE ..........................69 Inspections ..............................69 Guidelines..............................69 Annual Inspection by Brainlab........................70 Further Inspections ............................71 Damaged Equipment ..........................73 Procedure ..............................73 INDEX ..............................75 Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 6 TABLE OF CONTENTS Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 7: General Information

    Tel: +81 3 3769 6900 Japan Fax: +81 3 3769 6901 Feedback Despite careful review, this guide may contain errors. Please contact us at igs.manuals@brainlab.com if you have suggestions as to how we can improve this guide. Manufacturer Brainlab AG Olof-Palme-Str. 9...
  • Page 8: Legal Information

    Intel Corporation in the US and other countries. CE Label • The CE label indicates that the Brainlab product complies with the essential re- quirements of European Council Directive 93/42/EEC, the Medical Device Di- rective (MDD).
  • Page 9: Symbols

    Such problems include device malfunctions, device failure, damage to device or damage to property. Notes NOTE: Notes are formatted in italic type and indicate additional useful hints. Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 10: Intended Use

    Symbols on Hardware Components The following symbols may be found on the system: Symbol Explanation Potential equalization point IP20 IP Classification Do not reuse Do not resterilize Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 11 1mW wavelength 635 nm Radio device Consult accompanying documentation When the D and line below it are lined up, the camera is perpendicular to the base of the Camera Cart. Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 12 In doubt, consult your local representative or the technical service department. NOTE: Unless otherwise specified, the use of multiple socket outlet(s) is not permitted. Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 13: Training And Documentation

    Training Brainlab Training When using the navigation system for the first time, a Brainlab representative should be present for guidance. Start with procedures of low complexity, where you can easily verify how a navigation system will assist you and where the limitations are. Simulate procedures on cadavers and/or phantoms before using the system with a patient.
  • Page 14: Documentation

    Detailed technical information on the system, including specifica- Technical User Guide tions and compliances NOTE: Not all of the above-mentioned user guides are available or relevant for all Brainlab products. Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 15 They provide condensed information on using the software or hardware, and are intended as a supplement to the user guides. NOTE: Quick Reference Guides do not replace the user guides. Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 16 Training and Documentation Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 17: System Overview

    “ Curve system” in this user guide. Similarly, unless otherwise specified, the carts for both the Curve Dual Display and Curve Single Display shall be referred to as “Monitor Cart ” and “Camera Cart” in this user guide.
  • Page 18 Figure 1 Component ① Camera Cart - Curve Single Display ② Camera ③ Monitor ④ Touchscreen ⑤ Monitor Cart - Curve Single Display, including medical computer unit Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 19 Camera Cart - Curve Dual Display (with telescopic post and motorized controls) ② Camera ③ Monitors ④ Touchscreen ⑤ Monitor Cart - Curve Dual Display, including medical computer unit Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 20: Optical Tracking

    • The software uses the camera input to calculate the relative three-dimensional positions of the instruments and the patient reference arrays. Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 21: Monitor Cart

    NOTE: These controls also appear on the Curve Single Display, however they do not function. Cart Arm Components ② ③ ① ④ Figure 4 Component ① Upper arm (Curve Dual Display only) ② Monitor joint Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 22 Monitor Cart Component ③ Articulated arm ④ Lower arm Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 23: 3Rd-Party Connections

    • The device is configured to use channel 1 to 11 (each with a channel space of 22 MHz). This setting matches the regulatory requirements for USA, Canada, Japan, Europe, Australia, Hong Kong and New Zealand. Contact Brainlab support or an authorized partner in case of questions.
  • Page 24 • The device is configured to use all 79 available channels with a channel space of 1 MHz each. • The characteristic of modulation is frequency hopping spread spectrum (FHSS). Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 25: Camera Cart

    Height adjustment handle (② only) ⑥ Telescopic post (② only) ⑦ Camera control unit (② only) ⑧ Camera Cart base ⑨ Transportation handle with cable hooks ⑩ Camera handle ⑪ Camera Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 26 • IEC 60825-1 (2001) Conforms to standards • FDA/CDRH 21 CFR 1040.10 and 1040.11 (except for devia- tions pursuant to Laser Notice No. 50 dated July 26, 2001) Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 27: Camera Volume

    NOTE: You can also check the camera field of view in the software as described in the Software User Guides. Camera Accuracy To ensure the specified accuracy of the camera, adhere to the storage and operating conditions (see page 56). Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 28: Ups

    The Monitor Cart is equipped with an uninterruptible power supply (UPS) which provides power to the system during a power failure. NOTE: It is not possible to turn off the UPS. Contact Brainlab support if UPS deactivation is required. Powered Components...
  • Page 29: Ups Signals

    Long beep followed by until mains power is restored. Turn on system Battery empty short beeps again and allow UPS to charge for at least two hours. Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 30: Ups Battery

    Arrange for Brainlab support to replace the UPS battery every three years Battery life (if inspected regularly). The UPS is composed of two 12V, 12 Ah valve-regulated, spill-proof, main- Battery type tenance-free, lead-acid batteries. Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 31: Troubleshooting

    Brainlab support. Repair and Service Do not attempt to service your system. Contact Brainlab support for questions regarding repair and service. Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 32: Troubleshooting: Monitor Cart

    Possible Occurrences Power to the Monitor Cart Occurrence Possible Cause Check that the mains power cabling is correctly connected to No power to Monitor Cart power supply. Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 33: Troubleshooting: Monitor

    The power supply to the monitor may be too low. NOTE: In general, the backlight inverter in the display Backlight not working properly. is very robust and should not cause any problems. Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 34: Touchscreen

    • The driver that controls the mouse cursor not functioning. Cursor position on the screen Calibration of the cursor has been lost. Contact Brainlab sup- does not correspond to the part port. of the screen touched. Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 35: Failure Indication Screens

    If an external source has been attached to Display 1 In (or Dis- play 2 In with the Curve Dual Display), the type of signal is Error: Wrong or No Signal! not recognized and cannot be displayed. Please remove the Change source on Display In or source from the port.
  • Page 36: Troubleshooting: Ups

    UPS emits a long beep followed The UPS battery is completely empty. Fully charge the UPS by short beeps, then the system before using the system again. shuts down. Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 37: Ups Led Indicator And System Status

    Blinking System is running on UPS Steadily illuminated Battery is charging In case of power failure while charging, battery may not run for the full five minutes. Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 38: Troubleshooting: Camera Cart

    • If green camera status LED is off, communi- cation is not possible: Reboot device NOTE: If you are having problems with your camera, contact Brainlab support. Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 39: Electrical Safety

    To avoid the risk of electrical shock, the Monitor Cart must only be connected to a mains power supply with protective earth. The line connector fuse must have a 16A rating. Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 40: Camera Cart - Curve Dual Display

    Introduction 4.1.2 Camera Cart - Curve Dual Display Camera Cart Classification The Camera Cart - Curve Dual Display is classified as Class I Equipment according to IEC 60601-1 and must be tested accordingly. Classification Definition Refers to equipment classification regarding protection against electric shock.
  • Page 41: Recurrent Test Requirements

    • Informs Brainlab immediately in writing if the 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.
  • Page 42: Testing Overview

    If a test does not pass, device must be repaired by Brainlab support. After repair, repeat the entire electrical safety test from the beginning.
  • Page 43: Safety Inspection Form - Recurrent Tests

    Remove all devices that have been connected, e.g., measurement lines. Critical Values Test Step Normal Condition ≤ 0.3 Ω Protective earth resistance ≤ 500 µA Equipment leakage current Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 44 Enter the maximum measured values in the table below: Test Step Normal Condition Passed? Protective earth resistance Equipment leakage current Serial number of measuring device: ________________________ Calibration valid through (date): ________________________ Test performed (date):_________________by: __________________________________ Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 45: Performing Tests

    Connect the measurement tip of your measuring device with the conductive parts shown in the table below and measure the resistance. If a test does not pass, device must be repaired by Brainlab support. After repair, repeat the entire electrical safety test from the beginning.
  • Page 46: Equipment Leakage Current

    ( Curve Dual Display only) Left screw on inner articulat- ed joint Left screw on inner articulat- ed joint of second arm ( Curve Dual Display only) Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 47 Screw on left side of Moni- tor Cart transport handle Composite In plug at con- nection panel On/off button Screw on camera rotation hinge Camera pitch hinge Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 48 Measured Value Test Passed? Screw on left under side of Camera Cart transport han- Screw on left side of the post fixation to the Camera Cart transport handle Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 49: Electrical Safety Test - Medical Electrical System

    • Informs Brainlab immediately in writing if the equipment is deemed unsafe. Inspections by Brainlab Personnel • 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.
  • Page 50: Testing Medical Electrical Systems

    If a test does not pass, device must be repaired by Brainlab support. After repair, repeat the entire electrical safety test from the beginning.
  • Page 51: Safety Inspection Form - Medical Electrical Systems

    Connect Monitor Cart and Camera Cart using the camera cable and plug Monitor Cart into mains power supply using the original Brainlab mains power cable. If you are using a Curve Dual Display system, also connect the Camera Cart - Dual Display to supply mains using the origi- nal Brainlab mains power cable.
  • Page 52 Electrical Safety Test - Medical Electrical System Test Step Normal Condi- Single Fault Passed? tion Condition Touch current Serial number of measuring device: ________________________ Calibration valid through (date): ________________________ Test performed (date):_________________by: __________________________________ Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 53: Touch Current For Medical Electrical Systems

    Camera pitch hinge Screw on left under side of Camera Cart transport han- Screw on left side of the post fixation to the Camera Cart transport handle Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 54 Electrical Safety Test - Medical Electrical System Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 55: Compliances And Specifications

    Power Specifications - North America In North America: if the unit is connected to 240 V, only connect it to a center-tapped outlet labeled 240 V power supply. Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 56: Environmental Requirements

    -10°C (14°F) to 50°C (122°F) 10°C (50°F) to 35°C (95°F) Humidity 10% to 90% non-condensing 30% to 75% non condensing Pressure 500 hPa to 1060 hPa 700 hPa to 1060 hPa Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 57: System Specifications

    Monitor Cart - Curve Single Monitor Cart - Curve Dual Display Display Weight 76 kg 92 kg Footprint 757 x 757 mm 757 x 757 mm Height 1499 mm 1499 mm Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 58: Technical Specifications

    0.3 mm RMS (Root Mean Square) Camera Cart - Curve Single Display Input Voltage 24 Vdc Power Consump- 15 W tion Tracking Accuracy 0.3 mm RMS (Root Mean Square) Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 59: Compliances

    The system should not be used adjacent to, or in direct contact with other equipment. If this cannot be avoided, normal operation must be verified in the configuration in which it will be used. Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 60: General Electromagnetic Immunity

    The user is responsible 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. Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 61: Electromagnetic Immunity, Curve System

    Recommended separation distance: RF IEC kHz to 80 61000-4-6- 1 2 P 80 MHz to 800 MHz 1 2 P 2 3 P 800 MHz to 2.5 GHz Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 62 Curve system. (b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 63: Rf Communications Equipment

    NOTE: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 64: Tested Cables

    Category 2 HDMI, Type A plug connector; max. 5 m long Coax cable (min. 0.5/3.7 diameter), shielded, terminated, 75 SDI In Ohm; max. 5 m long Microscope Provided by Brainlab; 10 m long Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 65: Hospital Network

    • Secured wireless network Network Precautions When integrating the Curve Dual Display system into a wireless hospital network, select an adequate encryption (e.g., WPA2) to protect patient data from unauthorized access. Streaming the display content of the Curve system or using session sharing may create high traffic load on the hospital network.
  • Page 66: Power Plugs

    “Hospital Only” (“Hospital Grade” in North America). Only insert the main plug into a socket outlet that is protectively earthed. Do not negate the protective action by the use of an extension cable. Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 67: Regional Power Plugs

    COMPLIANCES AND SPECIFICATIONS 5.5.2 Regional Power Plugs Power Plugs (Examples) Power Plug Region Switzerland Australia South Africa Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 68: Usb Flash Drives

    USB Flash Drives USB Flash Drives 5.6.1 Overview General Information You can use a USB flash drive to transfer patient data between Brainlab planning and navigation stations. Specifications The specifications of the USB flash drives provided by Brainlab are shown below: Interface USB 2.0...
  • Page 69: Maintenance

    Brainlab. Before Using the System If the system has not been used for an extended period of time, verify that everything operates normally before beginning patient treatment. Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 70: Annual Inspection By Brainlab

    Arrangement • If you have a service contract, Brainlab automatically performs the annual inspection. • If you do not have a service contract, contact Brainlab support to arrange the inspection. Scope This inspection covers all components and functions as well as the items specified on the safety inspection form.
  • Page 71: Further Inspections

    • The system should continue to work. The UPS emits regular beeps, and the LED indicates that the battery is activated. NOTE: UPS details are provided from page 28. Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 72 • Check of mechanical support system (arm, wheels and locks) • Functional test of device Monitor Cart • Check of mechanical support system (arm, wheels and locks) System • Electrical safety test (see page 41) Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 73: Damaged Equipment

    • Provides you with a cost estimate for repair or replacement • Informs you when your system is expected to be operational again (usually within 48 hours) Return Instructions Refer to the System User Guide. Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 74 Damaged Equipment Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 75: Index

    RF communications equipment..........63 guides..................14 signals UPS..................29 size measurements..............57 storage conditions..............56 hospital network support..................7 hazards...................65 symbols requirements................65 hardware.................10 user guide.................9 system revision numbers............10 system size.................57 Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 76 34 UPS..................36 UPS.................... 28 battery disposal..............30 charging battery..............30 LED indicators..............29,37 signals................29,37 USB flash drives.................68 user guides.................14 WEEE...................8 weekly inspection............... 71 WLAN..................23 Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0...
  • Page 78 Art-No. 60915-47EN *60915-47EN*...

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