User Manual
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A New Vision of Precision
for MRI
User Manual a
A New Vision of Precision
for MRI
User Manual NOTICE OF CONFIDENTIALITY: The information contained in this document is confidential to assigned recipient and is intended for use of the addressee only. Unauthorized use, disclosure or copying is strictly prohibited and may be unlawful. If you have received this document in error, please immediately notify Galil Medical ltd.
November 2012
DOC000074 Rev. C
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SeedNet™ Gold MRI User’s Manual
SeedNet™ for MRI Users: Please read this document carefully before using the SeedNet™ System.
For additional information, contact:
Galil Medical Ltd. Sha’ar Yokneam, Tabor 1 P.O.B. 224 Yokneam 20692 Israel Tel: 972-4-9093200 Fax: 972-4-9591077
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SeedNet™ Gold MRI User’s Manual
Table of Contents
Table of Contents LIST OF WARNINGS AND CAUTIONS…………………..………….…...…...IX Chapter 1: SAFTY 1-1 1.1 General…………….. ... 1-1 1.2 Definitions of Warnings and Cautions ... 1-2 Warnings…………….. ... 1-2 Cautions…… ... 1-2 1.3 Proper Use…. ... 1-2 1.4 Explosion and Fire Hazard ... 1-3 1.5 Gas Cylinder Safety ... 1-3 1.6 Burn Hazard.. ... 1-4 1.7 Grounding…. ... 1-4 1.8 Compliance with International Standards ... 1-4 1.9 Equipment Classifications ... 1-4 1.10 Accompanying Labels ... 1-5 Chapter 2: INDICATIONS FOR USE ... 2-1 2.1 Indications for Use ... 2-1 2.2 Who is a Qualified User? ... 2-1 2.3 Clinical Decisions ... 2-1 Chapter 3: SYSTEM DESCRIPTION ... 3-1 3.1 Concept of Operation ... 3-1 General…….. ... 3-1 3.2 System Operating Modes ... 3-2 3.3 SeedNet™ Structure ... 3-2 General…….. ... 3-2 The SeedNet™ Machine ... 3-2 Machine Back Panel…. ... 3-5 The SeedNet™ Connectors Panel ... 3-6 Accessories…. ... 3-6 Chapter 4: INSTALLATION AND SETUP... 4-1 4.1 Space and Positioning Requirements ... 4-1 4.2 Electrical Requirements ... 4-1 4.3 Shipment Components ... 4-1 4.4 Installation…. ... 4-2 Chapter 5: OPERATING INSTRUCTIONS ... 5-1 5.1 Training……. ... 5-1 5.2 Turning On the SeedNet™ System ... 5-1 5.3 Connectors Panel ... 5-3 5.4 Connecting the Cable & Probe to the Machine………………….………..5-3 Connecting the cable to the machine………………...……………………5-3 Connecting the disposable probe to the cable……………………………..5-4 5.5 Functionality Test of the Needles or Probes ... 5-5 5.6 Temperature Sensor Installation... 5-6 5.7 Operating Procedures ... 5-6 Temperature Sensor ... 5-6 Control of the Probes... 5-6 Freezing Procedure ... 5-7 Thawing Procedure ... 5-7 5.8 Shutdown of SeedNet™ System ... 5-8
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Table of Contents
Chapter 6: COMPUTER INTERFACE ... 6-1 6.1 Using the Trackpad ... 6-1 6.2 Boot Up Procedure ... 6-1 Error #1……. ... 6-1 Error #2……. ... 6-1 Freezing Gas Pressure Warning ... 6-2 Thawing Gas Pressure Warning ... 6-3 ILLIGAL Barcode Message………………………………………………6-3 6.3 PROSTATE PROCEDURE……………….……………...………………6-5 6.3.1 The clinical data Screen……………………………………………….…..6-6 6.3.2 The Operation Screen……………………………………………………..6-7 Mutual Fields... 6-8 Template Layout Display ... 6-9 6.3.3 Functionality Test………………………………………………………..6-10 6.3.4 Choosing of Control Mode………………………………………………6-10 6.3.5 Intensity Control Mode ... 6-11 6.3.6 Temperature Control Mode ... 6-12 6.3.7 Template Layout Display Operation…………………………………….6-12 "Insertion of Needles" ... 6-12 "Insertion of Temperature Sensors" ... 6-12 6.3.8 Saving Patient Log Files ... 6-13 6.4 KIDNEY PROCEDURE……………….……………...…………...……6-14 6.4.1 The clinical data Screen………………………………………………...6-15 6.4.2 The Operation Screen…………………………………………………...6-16 6.4.2.1 Operation Screen when using NEEDLES (Low Press. - L.P.)………….6-16 6.4.2.2 Operation Screen when using PROBES (High Press. - H.P.)……….….6-18 6.4.3 Functionality Test………………………………………………………..6-19 6.4.4 Choosing of Control Mode………………………………………………6-19 6.4.5 Intensity Control Mode ... 6-19 6.4.6 Temperature Control Mode ... 6-20 6.4.7 Saving Patient Log Files…………………………………………………6-22 6.5 OTHER PROCEDURE……………….……………...…………...……..6-23 6.5.1 The clinical data Screen………………………………………………...6-24 6.5.2 The Operation Screen…………………………………………………...6-25 6.5.2.1 Operation Screen when using NEEDLES (Low Press. - L.P.)………….6-25 6.5.2.2 Operation Screen when using PROBES (High Press. - H.P.)…………. 6-27 6.5.3 Functionality Test………………………………………………………..6-28 6.5.4 Choosing of Control Mode………………………………………………6-28 6.5.5 Intensity Control Mode ... 6-28 6.5.6 Temperature Control Mode ... 6-29 6.5.7 Saving Patient Log Files………………………………………...……….6-31 Chapter 7: SYSTEM MAINTENANCE ... 7-1 7.1 General Cleaning ... 7-1 7.2 Sterilization… ... 7-2 7.3 Replacing the Gas Cylinders ... 7-2 7.4 The Supply and Refilling of Gas Cylinders ... 7-2 7.5 Spare Parts…. ... 7-3 7.6 Periodic Maintenance ... 7-3
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Table of Contents
Chapter 8: SEEDNET MRI Kit ... 8-1 8.1 General…….. ... 8-1 8.2 Layout... ... 8-2 8.3 Operation...…...…………...………...8-3 8.4 Connecting Needles to the Mobile Panel...8-4 8.5 Connecting Cable & Probe to the Mobile Panel...8-4 Chapter 9: ACCESSORIES ... 9-1 9.1 Galil Medical Needles & Probes ... 9-1 CryoNeedles procedure kit……………………………………………...9-2 CryoNeedles 90 Degrees US kit…………..………………………..…...9-2 Prostate Procedure Disposable kit…………..……………….…………...9-2 9.2 Temperatures Sensors ... 9-3 9.3 External Flexible Gas Hoses ... 9-3 9.4 SeedNet Template……………….………………………………….…..…9-4 9.5 Flexible Cables for Disposable Probes……………………………………9-4 9.6 Barcode Scanner……………………………………………...……...…...9-5 9.7 SmartWarmer – Urethral Warming System……………………………...9-5 9.8 Mobile Distribution Panel…………………………………………………9-6 9.9 Remote Control Unit………………………………………………………9-6 9.10 Guidance on the Use of the Probes………………………….…….……...9-7 Chapter 10: TROUBLESHOOTING ... .10-1 10.1 General……… ... …..10-1 10.2 Troubleshooting Guide ... 10-1 Chapter 11: SYSTEM SPECIFICATIONS ... 11-1 11.1 Technical Data... 11-1 11.2 Gas Specifications ... 11-2 11.3 Schematic Diagram of the System ... 11-3
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SeedNet™ Gold MRI User’s Manual
Table of Figures
Table of Figures FIGURE 1-1: MACHINE LABELS (FOR REFERENCE ONLY) ... 1-6 FIGURE 1-2: LABLES LOCATION ON MACHINE BACK PANEL... 1-7 FIGURE 3-1: THE SEEDNET™ MRI SYSTEM- GENERAL VIEW. ... 3-1 FIGURE 3-2: THE POWER CONTROL PANEL ... 3-2 FIGURE 3-3: THE SEEDNET™ GOLD MACHINE - BACK PANEL. ... 3-4 FIGURE 3-4: CONNECTORS PANEL ... 3-5 FIGURE 5-1: SAFETY CABLE LOCKING ... 5-1 FIGURE 5-2: CONNECTORS PANEL ... 5-3 FIGURE 5-3: PROBE CABLE ... 5-4 FIGURE 5-4: CONNECTING THE PROBE CABLE ... 5-4 FIGURE 5-5: DISPOSABLE PROBE ... 5-4 FIGURE 5-6: FUNCTIONALITY TEST (SINGLE NEEDLE) ... 5-5 FIGURE 6-1: ERROR MESSAGE # 1 ... 6-1 FIGURE 6-2: ERROR MESSAGE # 2 ... 6-2 FIGURE 6-3: FREEZING GAS PRESSURE WARNING ... 6-2 FIGURE 6-4: FREEZING GAS PRESSURE ABOVE 4500PSI ... 6-2 FIGURE 6-5: THAWING GAS PRESSURE WARNING ... 6-3 FIGURE 6-6: THAWING GAS PRESSURE ABOVE 4500PSI ... 6-3 FIGURE 6-7: ILLIGAL BARCODE MESSAGE ... 6-3 FIGURE 6-8: MACHINE MAIN SCREEN ... 6-4 FIGURE 6-9: MACHINE MAIN SCREEN WITH PRESSURE MESSAGES ... 6-4 FIGURE 6-10: PROSTATE PROCEDURE MAIN SCREEN ... 6-5 FIGURE 6-11: PROSTATE PROCEDURE MAIN SCREEN WITH BLISTER S/N. ... 6-6 FIGURE 6-12: CLINICAL DATA SCREEN (BEFORE ENTERING OPERATION SCREEN). ... 6-6 FIGURE 6-13: CLINICAL DATA SCREEN (ACCESSED FROM THE OPERATION SCREEN). . 6-7 FIGURE 6-14: NEW DISPOSABLE KIT MESSAGE. ... 6-8 FIGURE 6-15: OPERATION SCREEN ... 6-9 FIGURE 6-16: TEMPLATE LAYOUT DISPLAY ... 6-9 FIGURE 6-17: OPERATION SCREEN DURING FUNCTIONALITY TEST ... 6-10 FIGURE 6-18: CHOOSING CM FOR A GROUP OF NEEDLES ... 6-11 FIGURE 6-19: CHANGE TO INTENSITY ... 6-12 FIGURE 6-20: AFTER PRESSING EXIT OR START NEW PROCEDURE ... 6-13 FIGURE 6-21: END PROCEDURE ... 6-13 FIGURE 6-22: FINAL EXIT ... 6-13 FIGURE 6-23: CAN NOT MIX PROBES / NEEDLES MESSAGE ... 6-14 FIGURE 6-24: KIDNEY PROCEDURE MAIN SCREEN ... 6-15 FIGURE 6-25: KIDNEY CLINICAL SCREEN (BEFORE ENTERING OPERATION SCREEN). 6-15 FIGURE 6-26: NEW DISPOSABLE PRODUCT MESSAGE. ... 6-16 FIGURE 6-27: KIDNEY PROCEDURE OPERATION SCREEN FOR NEEDLES ... 6-17 FIGURE 6-28: KIDNEY PROCEDURE OPERATION SCREEN FOR PROBES ... 6-19 FIGURE 6-29: CHOOSING CONTROL MODE FOR ... 6-20 FIGURE 6-30: CHANGE TO INTENSITY ... 6-21 FIGURE 6-31: NO TEMPERATURE SIGNAL ... 6-21 FIGURE 6-32: AFTER PRESSING EXIT OR START NEW PROCEDURE ... 6-22 FIGURE 6-33: END PROCEDURE ... 6-22 FIGURE 6-34: FINAL EXIT ... 6-22 FIGURE 6-35: CAN NOT MIX PROBES / NEEDLES MESSAGE ... 6-23
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SeedNet™ Gold MRI User’s Manual
Table of Figures
FIGURE 6-36: OTHER PROCEDURE MAIN SCREEN ... 6-24 FIGURE 6-37: OTHER CLINICAL SCREEN (BEFORE ENTERING OPERATION SCREEN). . 6-24 FIGURE 6-38: NEW DISPOSABLE PRODUCT MESSAGE. ... 6-25 FIGURE 6-39: OTHER PROCEDURE OPERATION SCREEN FOR NEEDLES ... 6-26 FIGURE 6-40: OTHER PROCEDURE OPERATION SCREEN FOR PROBES ... 6-28 FIGURE 6-41: CHOOSING CONTROL MODE FOR ... 6-29 FIGURE 6-42: CHANGE TO INTENSITY ... 6-30 FIGURE 6-43: NO TEMPERATURE SIGNAL ... 6-30 FIGURE 6-44: AFTER PRESSING EXIT OR START NEW PROCEDURE ... 6-31 FIGURE 6-45: END PROCEDURE ... 6-31 FIGURE 6-46: FINAL EXIT ... 6-31 FIGURE 8-1: TYPICAL LAYOUT OF THE SEEDNET MRI KIT INSTALLATION ... 8-2 FIGURE 8-2: SEEDNET MOBILE DISTRIBUTION PANEL ... 8-2 FIGURE 8-3: CONNECTING THE MOBILE DISTRIBUTION PANEL CABLES ... 8-3 FIGURE 8-4: CONNECTING NEDDLES TO THE MOBILE PANEL... 8-4 FIGURE 8-5: PROBE CABLE ... 8-5 FIGURE 8-6: CONNECTING PROBE FLEXIBLE HOSE TO THE MOBILE PANEL ... 8-5 FIGURE 9-1: FIVE SEEDNET™ NEEDLES PACK ... 9-1 FIGURE 9-2: GALIL MEDICAL STANDARD PROBES ... 9-1 FIGURE 9-3: SPECIALLY DESIGINED TEMPLATE ... 9-2 FIGURE 9-4: EXTERNAL TEMPERATURE SENSOR ... 9-3 FIGURE 9-5: EXTERNAL GAS SUPPLY HOSE (WITH REGULATOR) ... 9-3 FIGURE 9-6: SEEDNET TEMPLATE... 9-4 FIGURE 9-7: PROBE CABLE ... 9-4 FIGURE 9-8: BARCODE READER ... 9-5 FIGURE 9-9: SMARTWARMER ... 9-5 FIGURE 9-10: SEEDNET MOBILE DISTRIBUTION PANEL ... 9-6 FIGURE 9-11: RCU……. ... 9-6 FIGURE 11-1: SCHEMATIC DIAGRAM OF THE SEEDNET™ SYSTEM. ... 11-3
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SeedNet™ Gold MRI User’s Manual
List of Warnings and Cautions
List of Warnings and Cautions Chapter 1: Safety
Caution The SeedNet™ is a sophisticated cryo-ablation system for intra-body operations. Any procedures performed using this system must be done by validly licensed and board-certified surgeons who are trained and experienced in the use of this system. Do not use this system if you have not been adequately trained in its use. Also, do not use this system until you have read the User’s Manual in its entirety and fully understand its contents. While every effort has been made to make this User’s Manual comprehensible, certain sections may be unclear or difficult to understand, depending on the user's background and experience. Do not use this system if there is any instruction, direction, precaution or note which you do not understand or which is unclear. Contact an authorized Galil Medical representative for further information and clarification before proceeding to use the system. The supplier and manufacturer of this system do not claim that it will be useful for assisting with the treatment of any particular condition or set of circumstances. The surgeon using the system is responsible in full for assessing each situation, based on his own experience and on the patient’s condition. While experience has shown that the system is useful for certain applications in cryotherapy, no representation or warranty has been or will be made that the system is useful for any specific person or condition. US federal law restricts this device to sale by or on order of a physician.
! Warning Do not use the workstation or the gas cylinders for any purpose other than running the SeedNet™ System.
! Warning Always turn off the SeedNet™ System and remove the key when not in use. Never allow untrained personnel to operate the SeedNet™ System.
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SeedNet™ Gold MRI User’s Manual
List of Warnings and Cautions
! Warning Before starting any cryosurgical procedure, sufficient freezing and thawing gas, in the external cylinders, must be available to the system. See page 3-5, Gas Supply System, for further details.
! Warning High-pressure gas is dangerous if handled improperly. The energy stored under pneumatic pressure may cause serious injury or death. Local laws and safety rules regarding pressurized gas systems, reservoirs and components should always be observed. Maintenance of high-pressure gas systems should be performed by authorized personnel only.
! Warning Use the Freeze and Thaw operating modes ONLY when the needle is placed in the target tissue. Never touch the tip of the needle or probe while the needle is being activated.
Chapter 2: Indications for Use
! Warning If you do not meet the criteria for a qualified user, you should not use the SeedNet™ System.
Chapter 3: System Description
Caution Depress the emergency stop button only in cases of emergency. It is recommended to exit the SeedNet™ System and software by the procedure given in section 5.7. Excessive use of the emergency stop button may cause damage to the computer workstation.
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SeedNet™ Gold MRI User’s Manual
List of Warnings and Cautions
Chapter 4: Installation and Setup
Caution After positioning the unit, lock the front wheel brakes.
! Warning The SeedNet™ System must be unpacked, installed and tested by a Galil Medical authorized technician only.
Chapter 5: Operating Instructions
! Warning • Only practitioners who have taken the SeedNet™ training course are authorized to use the SeedNet™ System. • Do not use the SeedNet™ System until you have read the User’s Manual in its entirety and fully understand its contents. • Do not start procedure before verifying that the system is fully operational
! Warning Do not turn the handles of the gas cylinder valves to the fully opened position. Ensure that all gas cylinder valves are opened before starting any cryosurgical procedure. Check that the reading on the pressure gauges is more than the minimum recommended values: 4300psi (297bar, 29.7MPa) for freezing and thawing gas.
! Warning Perform the functionality test on each group of needles or to any probe before use. A defective needle must never be used.
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SeedNet™ Gold MRI User’s Manual
List of Warnings and Cautions
! Warning A defective needle or probe with a gas leak can cause a gas embolism in the patient and must never be used. Ice formation (at this stage) means that Argon gas is connected to the Helium lines.
! Warning A defective needle or probe, which does not respond to operating mode commands or that has been damaged in any way, must not be used.
! Warning Use the Freeze and Thaw operating modes ONLY when the needle is placed in the target tissue.
! Warning Turn the freezing gas shutoff valve to the “OFF” position if the freezing operation continues after switching to the OFF operating mode. Allow for natural thawing of the needle or probe before removing it from the patient.
! Warning The release of the needle or probe from the target tissue should ALWAYS be based on clinical judgment.
! Warning Before starting any cryosurgical procedure, sufficient freezing and thawing gas, in the external cylinders, must be available to the system. See page 3-5, Gas Supply System, for further details.
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SeedNet™ Gold MRI User’s Manual
List of Warnings and Cautions
Chapter 7: System Maintenance
! Warning Maintenance by the user should be performed only when the unit is shut down and disconnected from electrical power and gas sources. Performing maintenance procedures with the system ON and/or under gas pressure may be hazardous to the user and/or destructive to the system.
! Warning Do not allow any liquid to enter the Galil Medical SeedNet™ system connectors or the accessory connectors.
!
Warning Do not mix full and empty cylinders. Always install a fully charged Argon gas cylinder and/or fully charged Helium gas cylinder.
! Warning The SeedNet™ System is not user-serviceable.
! Warning Periodic service for the gas cylinders must be performed ONLY by a Galil Medical certified gas supplier. Chapter 8: SeedNet™ MRI Kit
! Warning The initial setup of the SeedNet™ system to be used with a MRI device shall be performed ONLY by authorized Galil Medical personnel.
! Warning The SeedNet™ rack is neither MR safe nor MR compatible. The rack must never be inserted into a magnet room.
Caution Only connect to the video output in conformance with the specification IEC950/EN60950.
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SeedNet™ Gold MRI User’s Manual
List of Warnings and Cautions
! Warning Qualified MRI personnel must be present when making all connections prior to a cryosurgical procedure.
Caution The SeedNet™ monitor display may be distorted due to the MR environment. It is highly recommended to use the video output to display the SeedNet™ screens on the main console and in-bore monitors. While every effort has been made to reduce imaging artifacts while using the Probes within the magnet bore, some artifacts may still be present (Depending on the imaging resolution and procedure).
Chapter 9: Accessories
Caution Handle needle or probe with care. Do not bend the needle unnecessarily. Make sure that the connector of the needle or probe does not come in contact with any liquid. Keep connector covered.
! Warning Temperature sensors must be used as the control device while using SeedNet™ Chapter 10: Troubleshooting
! Warning Do not attempt to perform any troubleshooting or corrective action beyond those specified in the following guide. Any malfunction not listed in the guide, or persisting after the recommended action has been taken, must be referred to Galil Medical.
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SeedNet™ Gold MRI User’s Manual
Safety
Chapter 1: Safety This manual is designed to serve as an accompanying document to the SeedNet™ System. It is not intended to take the place of the user’s training course, which must be completed before use of the SeedNet™ System.
1.1 GENERAL The SeedNet™ System must be unpacked, installed and tested by qualified Galil Medical personnel (See Chapter 4 – Installation and setup, for further information). Do not use the SeedNet™ System on patients until you have completed the SeedNet™ training course (See Chapter 5 – Operating Instructions, for further information).
Caution The SeedNet™ is a sophisticated cryo-ablation system for intra-body operations. Any procedures performed using this system must be done by validly licensed and board-certified surgeons who are trained and experienced in the use of this system. Do not use this system if you have not been adequately trained in its use. Also, do not use this system until you have read the User’s Manual in its entirety and fully understand its contents. While every effort has been made to make this User’s Manual comprehensible, certain sections may be unclear or difficult to understand, depending on the user's background and experience. Do not use this system if there is any instruction, direction, precaution or note, which you do not understand or which is unclear. Contact an authorized Galil Medical representative for further information and clarification before proceeding to use the system. The supplier and manufacturer of this system do not claim that it will be useful for assisting with the treatment of any particular condition or set of circumstances. The surgeon using the system is responsible in full for assessing each situation, based on his own experience and on the patient’s condition. While experience has shown that the system is useful for certain applications in cryotherapy, no representation or warranty has been or will be made that the system is useful for any specific person or condition. US federal law restricts this device to sale by or on order of a physician.
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SeedNet™ Gold MRI User’s Manual
Safety
1.2 DEFINITIONS OF WARNINGS AND CAUTIONS Warnings Warning messages indicate procedures or practices which, if not observed, could result in personal injury. Do not proceed beyond a WARNING message until the conditions are fully understood and met.
Cautions Caution messages indicate procedures, which if not observed, could result in loss of data or damage to equipment. Do not proceed beyond a CAUTION message until the indicated conditions are fully understood and met. List of warnings and cautions is detailed on pages vii - xii.
1.3 PROPER USE
!
Warning Do not use the workstation or the gas cylinders for any purpose other than running the SeedNet™ System. The workstation supplied with the SeedNet™ System is intended to serve as a dedicated workstation for the SeedNet™ System and should not be used for any other purpose. The gas cylinders supplied with the SeedNet™ System are intended to serve as dedicated gas cylinders for the SeedNet™ System and should not be used for any other purpose.
!
Warning Always turn off the SeedNet™ System and remove the key when not in use. Never allow untrained personnel to operate the SeedNet™ System.
! Warning Before starting any cryosurgical procedure, sufficient freezing and thawing gas, in the external cylinders, must be available to the system. See page 3-5, Gas Supply System, for further details.
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Safety
1.4 EXPLOSION AND FIRE HAZARD The SeedNet™ System includes electronic devices that may emit sparks and should therefore not be operated in the presence of flammable fumes, e.g., flammable anesthetics or volatile substances. An easily accessible fire extinguisher in the vicinity of the unit is recommended. Verify that the SeedNet™ System has been ordered according to the appropriate line voltage of your country (100-120 VAC or 230 VAC). Only replacement fuses that are rated at T 6.3A, 250V Slow Blow for 230V line voltage or for 100-120V line voltage, should be used. Fuses should only be replaced by trained Galil Medical technicians or under direction of Galil Medical personnel. The SeedNet™ System is designed to function at an operating pressure of up to 4500psi (310bar, 31MPa). Pressure regulators set to the machine working pressure (see chapter 3 for details) must be used. The freezing and thawing gas should only be ordered from a Galil Medical certified gas supplier.
1.5 GAS CYLINDER SAFETY
!
Warning High-pressure gas is dangerous if handled improperly. The energy stored under pneumatic pressure may cause serious injury or death. Local laws and safety rules regarding pressurized gas systems, reservoirs and components should always be observed. Maintenance of high-pressure gas systems should be performed by authorized personnel only.
Gas cylinders should be kept away from heat sources. Gas cylinders should be handled with care to avoid any mechanical damage. Particular attention should be paid to avoiding damage to the valve. If substantial mechanical damage is suspected, the gas cylinder in question should be sent for inspection to an authorized dealer. Do not use the gas cylinder if the date for inspection has expired. Return them to an authorized distributor for inspection.
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SeedNet™ Gold MRI User’s Manual
Safety
1.6 BURN HAZARD The distal portion of the needle can reach very low (-110C) and very high (+70C) temperatures.
!
Warning Use the Freeze and Thaw operating modes ONLY when the needle is placed in the target tissue. Never touch the tip of the needle while the needle is being activated.
1.7 GROUNDING The unit is grounded through the grounding conductor in the power cord. A protective ground, by way of the grounding conductor in the power cord, is essential for safe operation. Always plug the unit into a properly grounded “Hospital Grade” outlet. An extra external grounding port is located on the rear of the machine under the cable’s reel.
1.8 COMPLIANCE WITH INTERNATIONAL STANDARDS The SeedNet™ System is designed and built according to the guidelines given in the international standards of ASTM Designation F882-96A standard performance and safety specification for cryosurgical medical instruments.
1.9 EQUIPMENT CLASSIFICATION Electric shock protection: Class I, Type BF. Protection against ingress of liquids: Ordinary equipment. Not suitable for use in presence of flammable anesthetic mixture with air or nitrous oxide. Mode of operation: Continuous.
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SeedNet™ Gold MRI User’s Manual
1.10
Safety
ACCOMPANYING LABELS
Figure 1-1 (on Page 1-6) show the labels affixed to the SeedNet™ System. Figure 1-2 (on page 1-7) illustrates their locations on the unit. Labels description: Label 1 - Specifies the maximum inlet pressure from an external gas supply source. Label 2 - Argon IN port. Label 3 - Helium IN port. Label 4 - Argon pressure discharge valve. Label 5 - Helium pressure discharge valve. Label 6 - CSA, Label. Label 7 - Main Freezing shutoff valve label (located above the SeedNet manifold). Label 8 - Identification label. It states the manufacturer’s name and address, date of manufacturing, model and serial number of the unit and the electrical specifications of the unit. Label 9 - Warnings of gas cylinders handling. Label 10 - US federal law restricts this device to sale by or on order of a physician, label. Label 11 - Label of the fuse type and rating of the unit (located on the power supply). Label 12 - “Hospital Grade” Label Label 13 - Video Output label. Label 14 - Printer label. Label 15 - Remote Control label. Label 16 - USB port label. Label 17 - LAN port label. Label 18 - RS232 port label.
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SeedNet™ Gold MRI User’s Manual
Safety
MAXIMUM INLET PRESSURE 4500 psi / 310 bar / 31 MPa
ARGON IN
HELIUM IN
Use only Galil Medical certified gas supplier
OFF
P.O. Box 224, Yokneam 20692, ISRAEL
ARGON DISCHARGE VALVE
WARNING READ MANUAL BEFORE ANY OPERATION WITH GAS CYLINDERS
SeedNet
ON NO. 1172463
HELIUM DISCHARGE VALVE
DISCONNECT THE SYSTEM FROM ELECTRICAL SUPPLY BEFORE ANY GAS CYLINDER HANDLING
CAUTION US FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A FHYSICIAN
ALWAYS RELIEVE SYSTEM PRESSURE BEFORE DISCONNECTIG ANY GAS CYLINDER
MAIN FREEZING GAS SHUTOFF VALVE
NEVER LEAVE ANY GAS CYLINDER CONNECTOR UNSECURED
GALIL MEDICAL Ltd.
FUSE T 6.3A SB
FUSE T 6.3A SB
100-120v
CAUTION GROUNDING RELIABILITY CAN ONLY BE ACHIEVED WHEN THE EQUIPMENT IS CONNECTED TO AN EQUIVALENT RECEPTACLE MARKED "HOSPITAL ONLY" OR "HOSPITAL GRADE"
VIDEO OUTPUT
PRINTER
REMOTE CONTROL
USB
LAN
RS232
INPUT VOLTAGE POWER SUPPLY - ELC000003 GALIL MEDICAL Ltd.
FUSE T 6.3A SB
FUSE T 6.3A SB
230 v INPUT VOLTAGE POWER SUPPLY - ELC000003
Figure 1-1: Machine Labels (for reference only)
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