Fax: +81 3 3769 6901 Expected Service Life Brainlab provides eight years of service for Curve Dual Navigation Station. Brainlab provides a minimum of five years of service for EM Tracking Device. During these periods of time, spare parts as well as field support are offered.
The CE label shows that the Brainlab product complies with the essential re- quirements of Council Directive 93/42/EEC (the "MDD"). According to the principles set out in the MDD, Curve and the EM Tracking Unit are Class IIb products. Disposal Instructions Only dispose of electrical and electronic equipment in accordance with statutory regu- lations.
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. 1.1 Curve Dual Navigation Station Ver. 1.2...
Do not use if packaging is damaged Keep away from sunlight/UV light Keep dry Quantity of products in packaging Batch code Serial Number Use by month YYYY Date of manufacture Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
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Markers on joints that identify the parking position. Marker indicates correct transport position for the height of telescopic post. Only move Camera Cart in transport position. Only move Monitor Cart in transport position. Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
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Symbols Symbol Explanation Visual hint: how to dock/undock system Danger of tilting: Do not move system when brakes are locked or if device is blocked by obstacles. Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
1.3.1 Using the System System Use The Curve system is a navigation platform used for Image Guided Surgery (IGS) incorporating: • An tracking system (optical or electromagnetic) • A computer unit that runs the software • Display units to display the navigation, including touch functionality for the user to interact with the software.
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Intended Use NOTE: Unless otherwise specified, the use of multiple socket outlet(s) is not permitted. Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
Brainlab representative. Supervised Support Before using the system for surgical procedures where computer-aided navigation is considered critical, perform a sufficient number of complete procedures with a Brainlab representative present to provide guidance where necessary. Responsibility This system solely provides assistance to the surgeon and does not substitute or replace the surgeon’s experience and/or responsibility during its use.
The information provided in this guide will help you to determine whether your navigation system is functioning properly. Use this guide, in combination with assistance from Brainlab support, to identify and troubleshoot possible problems. Do not attempt to service your system. Contact Brainlab support for questions regarding repair and service.
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GENERAL INFORMATION NOTE: Not all of the above-mentioned user guides are available or relevant for all Brainlab products. If you have questions regarding the user guides you received, contact Brainlab support. Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
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Training and Documentation Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
SYSTEM OVERVIEW SYSTEM OVERVIEW Component Overview Terminology The Curve Dual Navigation Station is referred to as “Curve system” in this user guide. It consists of the following parts: • Curve Dual Monitor Cart • Curve Dual Camera Cart • EM Tracking Unit Abbreviation UPS is used to abbreviate “uninterruptible power supply”...
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③ ④ ① ⑤ Figure 1 Component ① Camera Cart with telescopic post and motorized controls ② Camera ③ Monitors ④ Touchscreen ⑤ Monitor Cart, including medical computer unit Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
2.1.1 Optical Tracking General Information Curve is a wireless, touchscreen-operated planning and navigation system designed for pre- and intraoperative use. Optical tracking is achieved by a camera unit that emits and detects flashes of infrared light. • Reflective elements, affixed to reference arrays on the patient and to instrumentation, reflect the infrared signals back to the camera unit.
Monitor Cart Monitor Cart Display Figure 2 Cart Arm Components ② ③ ④ ① Figure 3 Component ① Upper arm ② Monitor joint ③ Articulated arm ④ Lower arm Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
The WLAN transmitter uses a frequency band for sending and receiving at 2400 - 2483.5 MHz or 5725 - 5850 MHz. The effective isotropic radiated power (EIRP) for the 2,4 GHz Band is 18,86 dBm, and for the 5 GHz Band is 21,87 dBm. Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
(LAN) interface with a rating of minimum 1 MOOP and a dielectric strength of minimum 1.5 kV. Connecting Curve to a hospital network may create an ME system according to IEC 60601-1:2005. Ensure that hospital network components are compliant to the relevant IEC standard.
Camera handle ③ Height adjustment handle ④ Telescopic post ⑤ Camera control unit ⑥ Camera Cart base ⑦ Transportation handle with cable hooks ⑧ Motor control unit ⑨ Camera Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
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• ANSI Z136.1 (2000) • IEC 60825-1 (2001) Conforms to standards • FDA/CDRH 21 CFR 1040.10 and 1040.11 (except for de- viations pursuant to Laser Notice No. 50 dated July 26, 2001) Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
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 64). Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
Powered Components If mains power is lost while using the Curve system, the complete Monitor and Camera Carts are powered for a maximum of five minutes (when battery is fully charged). In case of power failure while charging, battery may not run for the full five minutes.
Battery is completely empty. Switch off system 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. 1.1 Curve Dual Navigation Station Ver. 1.2...
Recharge time Two hours (full recovery) Run time Max. five minutes Arrange for Brainlab support to replace the UPS battery every three years Battery life (if inspected regularly). The UPS is composed of two 12 V, 12 Ah valve-regulated, spill-proof, main- Battery type tenance-free, lead-acid batteries.
It is recommended to keep the EM Tracking Unit running for about 10 minutes before using the system. In order to maintain system accuracy over the defined system lifetime, Brainlab authorized personnel must verify the accuracy of the EM Tracking Unit every three years.
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EM Field Generator ⑩ EM Field Generator fixation piece Check the EM Field Generator Fixation Plate and Positioning Arm for visible damage before use and do not used if damaged. Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
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⑤ Component ① Power connection ② EM instrument LEDs ③ Power LED ④ EM instrument ports ⑤ Tool extension port ⑥ Navigation system port ⑦ EM Field Generator port Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
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100 and 350 mm from the EM Field Generator front. ③ ② ④ ① ⑤ Component ① ② Side ③ Back ④ Available navigation volume ⑤ Ideal navigation volume Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
TROUBLESHOOTING TROUBLESHOOTING Introduction Chapter Information This chapter contains troubleshooting information for the major components of the Curve system: • Monitor Cart • Monitor • UPS • Camera Cart • EM Tracking Unit The purpose of this chapter is to provide you with specific information in order to recognize possible problems and communicate them to Brainlab support.
Troubleshooting: Monitor Cart Troubleshooting: Monitor Cart 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. 1.1 Curve Dual Navigation Station Ver. 1.2...
The backlight evenly illuminates the background of the active display so that pixels are visible. Occurrence Comment The backlight may need to be replaced (backlights The display is black. typically have a specified lifetime of five years). Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
• The driver that controls the mouse cursor not func- tioning. Cursor position on the screen does not Calibration of the cursor has been lost. Contact Brain- correspond to the part of the screen lab support. touched. Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
System is checking available signals. Information disappears after a few seconds and either the image is displayed or dis- No Signal! play signal has an error. In case of an error contact Brainlab Support. Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
UPS emits a long beep followed by The UPS battery is completely empty. Fully charge the short beeps, then the system shuts UPS before using the system again. down. Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
Status Indicates 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. 1.1 Curve Dual Navigation Station Ver. 1.2...
• 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. 1.1 Curve Dual Navigation Station Ver. 1.2...
A tracked instrument with a motorized element is held steady. (e.g., shaver) interferes with tracking while the motor is in use. Do not rely on tracking informa- tion while the motorized element is in use. Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
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Troubleshooting: EM Tracking Unit Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
Introduction 4.1.1 Curve Dual Navigation Station Curve Dual Navigation Station Classification The Curve Dual Navigation Station 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 Class I shock.
• 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.
Connect Monitor Cart and EM Tracking Unit using the provided connec- Applied Part Leak- tion cables. Plug Monitor Cart into the Tester using the original Brainlab age Current (type mains power cable. Test the equipment leakage current according to IEC 62353:2007 Chapter (EM Tracking only) 5.3.4.3.2 using the so-called “alternative measurement”, see Image 9 in...
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Report and evaluate Generate a report and determine whether the device is safe and effective. results After testing, check that the Curve system is restored to the conditions Check and prepare necessary for normal use before being returned into service.
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.
Point Tested Measured Value Test Passed? Display fixation screw Second display fixation screw Left screw on inner articulat- ed joint Left screw on inner articulat- ed joint of second arm Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
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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. 1.1 Curve Dual Navigation Station Ver. 1.2...
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EM instrument port at EM Base Station (type BF ap- plied part SIP/SOP) (for optional EM Tracking Unit) Housing screw on EM Base Station cover (for optional EM Tracking Unit) Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
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Performing Tests Point Tested Measured Value Test Passed? Tracking system connection on Monitor Cart (for optional EM Tracking Unit) Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
For example: Figure 11 Measurement Point Point Tested Measured Value Test Passed? Adapter plug on EM con- necting unit (one socket is sufficient for the measure- ment) Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
• 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.
(EM Tracking) • Start a software application. • Accurately track a Brainlab EM instrument. Report and evaluate Generate a report and determine whether the device is safe and effective. results Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
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ELECTRICAL SAFETY Test Step Instructions and Conditions After testing, check that the Curve system is restored to the conditions Check and prepare necessary for normal use before being returned into service. for normal use Remove all devices that have been connected, e.g., measurement lines.
Screw on camera rotation hinge 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. 1.1 Curve Dual Navigation Station Ver. 1.2...
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SIP/SOP) (for optional EM Tracking Unit) Housing screw on EM Base Station cover (for optional EM Tracking Unit) Tracking system connection on Monitor Cart (for optional EM Tracking Unit) Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
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Electrical Safety Test - Medical Electrical System Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
IP21: EM Base Station 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. 1.1 Curve Dual Navigation Station Ver. 1.2...
-10°C (14°F) to 45°C (113°F) (for a period of time not exceeding 15 Temperature weeks) Humidity 10% to 90% non-condensing Pressure 500 hPa to 1060 hPa NOTE: Transport/storage values are valid for the system when contained in the transport cases. Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
120 kg Footprint 757 x 757 mm Height 1499 mm EM Base Station Figure 12 Specification Value Height 350 mm Width 200 mm Length 100 mm Weight 2.5 kg Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
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200 mm Length 71 mm Weight 2.8 kg EM Field Generator Fixation Plate Figure 14 Specification Value Height 121 mm Width 300 mm Length 428 mm Weight 2 kg Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
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COMPLIANCES AND SPECIFICATIONS EM Field Generator Arm Figure 15 Specification Value Height 748 mm Width 110 mm Length 88 mm Weight 4 kg Instrument Adapter Figure 16 Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
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System Specifications Specification Value Diameter 19 mm Length 65 mm Weight 0.026 kg Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
24 Vdc Power Consumption 15 W Tracking Accuracy 0.3 mm RMS (Root Mean Square) DVI Converter Please refer to the Brainlab Instruction Leaflet, Converter Kit DVI to S-Video. Wireless LAN Specifications Specification Value Frequency bands 2.4 GHz and 5 GHz Data Modulation DSSS, OFDM for 2.4 MHz and OFDM for 5 GHz...
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Maximum Conducted Output Power For 5 GHz band: 21.87 dBm EM Tracking Unit Specification Value Input Voltage 26 VDC Power Consumption 40 W Tracking Accuracy 0.5 mm RMS (Root Mean Square) Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
Compliances 5.4.1 Electromagnetic Emissions Electromagnetic Environment Curve systems are intended for use in the electromagnetic environment specified in the table below. The user is responsible ensuring that the systems are used in such an environment. Declaration Guidance and manufacturer’s declaration regarding electromagnetic emissions:...
Compliances 5.4.2 General Electromagnetic Immunity Electromagnetic Environment Curve systems are intended for use in the electromagnetic environment specified in the following sections. 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.
RF IEC 150 kHz to Recommended separation distance: 61000-4-6- 80 MHz d = 1.17√P d = 1.17√P 80 MHz to 800 MHz d = 2.3√P 800 MHz to 2.5 GHz Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
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RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Curve system is used exceeds the applicable RF com- pliance level above, the Curve system should be observed to verify normal operation. If abnor- mal performance is observed, additional measures may be necessary, such as re-orienting or re- locating the Curve system.
Electromagnetic Environment Portable and mobile RF communications equipment can affect the systems. The Curve system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The Curve system user can help prevent electromagnetic interference by maintaining a minimum...
EM Tracking Unit Power Ca- EM Tracking Unit Data Cable 5 m Supported Output Resolutions The table below specifies the supported output resolutions for display output available on Curve. For more information on output resolution, contact Brainlab support. Displays Color Coding...
When integrating the Curve 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.
Power Plugs Power Plugs General Information The Curve system comes equipped with a specific power plug suitable for the region of use. Use of Specified Power Cords Only use power cords as specified by Brainlab. Do not extend power cords.
COMPLIANCES AND SPECIFICATIONS 5.5.1 Regional Power Plugs Power Plugs (Examples) Power Plug Region Switzerland Australia South Africa Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
USB Flash Drives USB Flash Drives General Information You can use a USB flash drive to transfer patient data between Brainlab planning and navigation stations. Handling USB Flash Drives When using a USB flash drive, do not directly touch the USB connector (metal part of the USB flash drive.
Inspections Expected Service Life The Curve system lifetime is dependent on factors such as method and duration of each use, and handling between uses. Careful functional testing and inspection of the Curve system before use is the best method for determining the end of lifetime.
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.
• 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. 1.1 Curve Dual Navigation Station Ver. 1.2...
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• Check of mechanical support system (arm, wheels and locks) • Accuracy verification by Brainlab support EM Tracking Unit • Functional test of device System • Electrical safety test (see page 46) Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
Using damaged equipment may cause patient injury. Required Information When you contact Brainlab support regarding a defect, you are asked for: • System serial number on the Monitor Cart type plate • Component serial number inscribed on the component (Monitor or Camera Cart or EM Base Station or EM Field Generator) •...
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Damaged Equipment Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2...
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