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Rez?m G2200 Operator'S Manual Download Page 17

3033-001 Revision D  January 2018 

©NxThera 2018 

Page 17 of 90   

 

1.5.4

 

 Symbols 

The following symbols may appear in this manual, on the generator labeling and/or packaging.  
Some of the symbols represent standards and compliances associated with the generator and its 
use. 

1.5.4.1

 

Generator Symbols 

Symbol 

Description of the Symbol 

Standard 

Title of symbol and 
(reference number) 

 

 
Indicates on the rating plate that the 
equipment is suitable for alternating 
current only; to identify relevant 
terminals 

IEC 60417 

Alternating current 
(5032) 

 

Manufacturer’s catalog number, so that 
the medical device can be identified 

 

ISO 15223-1:2016 

 

Catalog number 
(5.1.6) 

 

 

Electrostatic sensitive device 

Caution: Contains parts and assemblies 
susceptible to damage by electrostatic 
discharge (ESD) 

 

Contact with generator package should 
be avoided at low levels of relative 
humidity, especially if insulating 
footwear is being worn or the 
ground/floor is nonconductive. Low 
levels of relative humidity must in 
particular be expected on hot, dry 
summer days and very cold winter 
days. 

IEC 60417 

Electrostatic sensitive 
devices (5134) 

 

CE Marked per the Medical Device 
Directive 93/42/EEC of the European 
Union.  The Notified Body is SEMKO 
(ID#0413) 

MDD 93/42/EEC 

 

Compliance with 
MDD 93/42/EEC 

 

 

Consult accompanying documents   

(Printed in blue on generator label) 

ISO 7010:2011 

 

Refer to instruction 
manual/booklet 
(M002) 

 

 

Indicates the date when the medical 
device was manufactured 

ISO 15223-1:2016 

Date of Manufacture 
(5.1.3) 

Summary of Contents for G2200

Page 1: ... Generator Model G2200 WARNING Carefully read and understand all instructions indications warnings and cautions in this operator s manual prior to using the Rezūm Generator Failure to do so could result in compromised patient safety patient complications and or insufficient treatment ...

Page 2: ...3033 001 Revision D January 2018 NxThera 2018 Page 2 of 90 This page intentionally left blank ...

Page 3: ... 2 Potential Adverse Events 16 1 5 3 Reported Adverse Events 16 1 5 4 Symbols 17 1 5 4 1 Generator Symbols 17 1 5 4 2 User Interface Symbols 20 1 6 Operator Training Requirements 21 Chapter 2 Getting Started 22 2 1 Unpacking and Inspecting 23 2 1 1 Generator Controls and Connections 24 2 1 2 Display Screen Map 27 2 1 3 Audible Tones 28 2 1 4 Volume Control 29 2 1 5 Detachable Parts and Accessories...

Page 4: ... View Patient Info 53 3 1 6 5 1 Delete Record 54 3 1 6 5 2 View Record 55 3 1 6 5 3 Export Record 56 3 1 6 6 More Options 59 3 1 6 6 1 System Status 59 3 1 6 6 2 Export Logs 64 3 1 6 6 3 Treatment Monitor 66 3 1 6 6 4 Treatment Config 66 3 1 6 6 5 Servicing 66 Chapter 4 Maintenance and Service 67 4 1 Recommended Maintenance and Care 68 4 1 1 Visual Inspection 69 4 1 2 Cleaning the Rezūm Generator ...

Page 5: ... 75 5 2 Operating Storage and Transportation Specifications 76 5 3 Electromagnetic Compatibility Requirements 77 5 4 EN 60601 1 2 Compliance 84 Chapter 6 Troubleshooting 85 6 1 Troubleshooting Steps 86 6 2 Error Messages 87 6 3 Error Message Table 88 6 4 Obtaining technical assistance 90 ...

Page 6: ...Thera 2018 Page 6 of 90 Chapter 1 About the Rezūm Generator Overview This chapter contains information about the Rezūm Generator including safety Please make sure you read this entire instruction manual prior to using the Rezūm Generator ...

Page 7: ...rademark of the NxThera Corporation NxThera Corporation 2018 All rights reserved 1 2 Contact Information NxThera Inc 7351 Kirkwood Lane North Suite 138 Maple Grove MN 55369 USA www nxthera com Phone 1 763 515 0404 Toll Free 1 888 319 9691 Fax 1 763 515 2085 Emergo Europe Prinsessegracht 20 2514 AP The Hague The Netherlands ...

Page 8: ...for Use Intended Use and Contraindications The Rezūm generator is intended to be used with the NxThera Rezūm Delivery Device Kit Model D2201 only Refer to the Instructions for Use for the Rezūm Delivery Device Kit for the Indications for Use Intended Use and Contraindications ...

Page 9: ...is released gently denaturing the cell membranes and causing instantaneous cell death The denatured tissue is absorbed by the body over time The vapor condensation process also causes a rapid collapse of blood vessels in the ablation treatment zone resulting in a bloodless procedure The generator rapidly heats and converts sterile water into nearly pure or dry vapor at slightly above 100 C The gen...

Page 10: ...erator 1 5 1 Dangers Warnings and Cautions The symbol and signal words shown below identify potential hazard categories The definition of each category is as follows DANGER This alert identifies hazards that will cause serious personal injury or death WARNING This alert identifies hazards that may cause serious personal injury or death CAUTION This alert identifies hazards that may cause minor per...

Page 11: ...nplug the power cord from the outlet to prevent electric shock WARNING Do not modify this equipment without authorization of NxThera WARNING Carefully read and understand all instructions indications warnings and cautions in this operator s manual prior to using the Rezūm Generator Failure to do so could result in compromised patient safety patient complications and or insufficient treatment WARNI...

Page 12: ...ot attempt to service or maintain the generator while in use with a patient WARNING RF Interference Known RF sources such as cell phones radio or TV stations and two way radios may cause unexpected or adverse operation of this generator Consult qualified personnel regarding system configuration WARNING Shock Hazard Do not open disassemble or alter the Rezūm Generator Failure to observe this warnin...

Page 13: ...display facing away from the body 1 5 1 3 CAUTIONS CAUTION After cleaning allow complete drying before plugging into an outlet CAUTION Before conducting maintenance work turn the power OFF and unplug the power cord from the outlet to prevent electric shock CAUTION Before moving this generator turn the power OFF remove all accessories from the patient and unplug the power cord from the outlet CAUTI...

Page 14: ...he generator dry it thoroughly before turning the power on CAUTION Input voltage range is 100 to 240V at 50 to 60 Hertz Verify this voltage matches that of the power outlet CAUTION Observe the following cautions when connecting this generator with other equipment Ensure that the connected equipment is in accordance with the IEC60601 1 or IEC safety standards Employ additional protective measures e...

Page 15: ...ations equipment near the Rezūm Generator may affect its operation CAUTION Using this generator with the air vent blocked could cause a breakdown Clean this generator with care CAUTION When any of the following occur turn the power off remove all accessories from the patient and unplug the power cord from the outlet There is smoke or a strange odor leaking out of the generator The generator has be...

Page 16: ...suse of the device has potential for producing these adverse effects 1 5 3 Reported Adverse Events The types of device related or procedure related adverse events reported are typical of thermal BPH ablation procedures There were no clinically significant complications resulting from the treatment A summary of the adverse events observed in NxThera clinical studies is presented in the Rezūm Delive...

Page 17: ...5 1 6 Electrostatic sensitive device Caution Contains parts and assemblies susceptible to damage by electrostatic discharge ESD Contact with generator package should be avoided at low levels of relative humidity especially if insulating footwear is being worn or the ground floor is nonconductive Low levels of relative humidity must in particular be expected on hot dry summer days and very cold win...

Page 18: ...er cover ISO 15223 1 2016 Keep dry 5 3 4 Indicates the medical device manufacturer ISO 15223 1 2016 Manufacturer 5 1 1 Manufacturing internal part number reference Not Applicable Not Applicable Model Number Not Applicable Not Applicable Indicates generally elevated potentially hazardous levels of non ionizing radiation or to indicate equipment or systems e g in the medical electrical area that inc...

Page 19: ...Relative Humidity limits non condensing ISO 15223 1 2016 Humidity limitation 5 3 8 Indicates the manufacturer s serial number so that a specific medical device can be identified ISO 15223 1 2016 Serial number 5 1 7 Temperature limitations This symbol will specify an upper C max and lower C min temperature limit ISO 15223 1 2016 Temperature limit 5 3 7 This symbol indicates that the waste of electr...

Page 20: ...ution 5 4 4 Medical Equipment as to electrical shock fire and mechanical hazards only in accordance with ANSI AAMI ES 60601 1 AMD 1 2012 CAN CSA C22 2 No 60601 1 2014 ANSI AAMI ES 60601 1 AMD 1 2012 CAN CSA C22 2 No 60601 1 2014 Medical Equipment recognized by Underwriters Laboratory Inc Table 1 Generator Symbols 1 5 4 2 User Interface Symbols Symbol Description Priming the Delivery Device Perform...

Page 21: ...he generator is not intended to be deployed in settings or situations that promote use by untrained personnel Operation by untrained personnel can result in injury or death Persons authorized to operate the generator must have all the following minimum training Training as required by state province or country regulations Training on operation and use of the generator Additional training as requir...

Page 22: ...3033 001 Revision D January 2018 NxThera 2018 Page 22 of 90 Chapter 2 Getting Started Overview This chapter contains information on how to get started with your Rezūm Generator ...

Page 23: ...t your packing slip The Rezūm Generator is designed for simplicity of operation and set up and requires minimal assembly The following items are included in the Rezūm Generator box One 1 Rezūm Generator One 1 Operator s Manual One 1 Power cord 1 Carefully inspect each item as it is unpacked for any signs of damage that may have occurred during shipment 2 Check the components according to the packi...

Page 24: ...lly result in injury or device failures WARNING Do not connect a grounding wire from a grounding stud to a gas pipe or water pipe CAUTION Using this generator with the air vent blocked could cause a breakdown Clean this generator with care CAUTION Only NxThera approved equipment and accessories shall be connected to the generator CAUTION The Rezūm Generator USB port is only intended for use during...

Page 25: ...inge Cradle Holds water for vapor treatment C Electrical cable port The electrical cable is the RF energy line and the connections for the switches and thermocouples D Roller pump Delivers saline during procedure E Power Indicator Displays system status F Power switch Turns system on off G USB port Allows data from system to be exported onto USB device Table 3 Front and Top of Generator Descriptio...

Page 26: ...ormation about the generator L Fuse box Holds generator fuses M Power cord plug Connection plug for electrical power cord N Lid Cover to protect display screen syringe and pressure sensor ports O Handle Use to transport the device by hand P Air vent and speaker Incoming air vent both sides and speaker left side only Q Rubber feet on bottom and side Allows product to be stored on base or bottom end...

Page 27: ...es A Title Bar B Information Screen C Lower Toolbar Figure 4 Display Screen Map Item Description A Title Bar Brief title of the screen displayed B Information Screen Main area for screen information and error messages will be shown to the user Replace saline button is also available on the saline bag C Lower Toolbar The bottom of all screens except the start up screens will include the same lower ...

Page 28: ...or to the completion of a treatment 4 Treatment Ready Played when the system is ready to perform a treatment 5 Treatment and Priming Beep tone is repeated once per second while performing Priming and Treatment operations 6 Success Tone emitted when a full treatment has been administered after successful priming and as feedback while adjusting the volume 7 Error Message Two quick tones in successio...

Page 29: ...ymbol to decrease or silence the volume and touch the plus symbol to increase the volume A tone will be emitted upon each button press The Critical Error and Delivery Device Disabled alarm tones cannot be silenced by the volume control The volume resets to the default when the generator is turned off and on again Set the volume loud enough to be heard adequately in the actual use environment ...

Page 30: ...ts and accessories Detachable Parts Supplied with the Rezūm Generator Model Number Description Function Type 1519 001 Power cord 3 05 meter hospital grade power cord North American 15 amp Reusable 1519 002 Power cord 3 05 meter hospital grade power cord Continental Europe 10 amp Reusable 1519 003 Power cord 2 50 meter hospital grade power cord Swiss 10 amp Reusable Table 7 Detachable Parts Accesso...

Page 31: ...3033 001 Revision D January 2018 NxThera 2018 Page 31 of 90 Chapter 3 Using the Rezūm Generator Overview This chapter provides step by step instructions and sequence of operation for the Rezūm Generator ...

Page 32: ...ions where chemicals are stored This generator cannot be used in any room in which noise generating apparatuses are used such as an MRI room CT room X ray room etc CAUTION Do not place anything on this generator CAUTION Observe the following cautions when connecting this generator with other equipment Ensure that the connected equipment is in accordance with the IEC60601 1 or IEC safety standards ...

Page 33: ...ld affect the performance of this device Avoid operating the Rezūm Generator near cauterizers diathermy equipment FM 2 way radios or cellular phones Turn power off to radio cellular and other like equipment near the Rezūm Generator Refer to the EMI tables in Chapter 5 CAUTION The Rezūm Generator is intended to be used indoors at a medical facility or physician office environment only ...

Page 34: ...is essential for safe operation To avoid electrical shock plug the power cord into a properly wired receptacle use only the power cord supplied with the generator and make sure the power cord is in good condition WARNING Use a grounded AC outlet for the power supply and ground this generator WARNING Use only NxThera approved and specified parts accessories optional parts consumables and components...

Page 35: ...e turning the power on CAUTION When any of the following occur turn the power off remove all accessories from the patient and unplug the power cord from the outlet There is smoke or a strange odor leaking out of the generator The generator has been dropped or impacted by an object Liquid or foreign matter gets inside the generator If you think the generator may have been damaged To turn ON 1 Open ...

Page 36: ...s and a test screen WARNING In the event of power failure the generator will automatically shut off Turn the power button off Please remove the Delivery Device from the patient immediately per instructions in the IFU 3032 0XX Section 9 Turn on again to restart the generator to begin a new therapy session Figure 7 NxThera Start up Screens ...

Page 37: ...y 2018 NxThera 2018 Page 37 of 90 Figure 8 NxThera Test Screen 4 It will automatically run the Start up Diagnostics During this time the test screen is displayed and a bar and text will indicate status of the tests on the screen ...

Page 38: ...eted the generator will display the Delivery Device Setup screen Figure 9 Deliver Device Setup After all connections are properly made a message will be displayed for 5 seconds letting the user know that items have been connected and then the Priming screen will be displayed Figure 10 Connection Message ...

Page 39: ...ged Figure 11 Ready for Priming When the operator starts priming the Delivery Device a progress bar will be initiated and displayed The text will change and a tone will be generated to indicate that the operation is in progress Priming is initiated by deploying the needle and holding the Delivery Device vapor activation button for the priming duration which lasts approximately 30 seconds A message...

Page 40: ...igure 12 Priming Screen Figure 13 Priming Complete The Setup Complete will be displayed when the Delivery Device has been successfully primed There will also be an audible tone that indicates success Pre treatment vapor cycle shall be performed prior to treatment ...

Page 41: ...90 Figure 14 Successful Primed Screen If the device is not properly primed an error message will be displayed to the user Upon resolution of the issue and closure of the error message the screen will display the Priming Screen and the steps should be repeated ...

Page 42: ...of the following occur turn the power off remove all accessories from the patient and unplug the power cord from the outlet There is smoke or a strange odor leaking out of the generator The generator has been dropped or impacted by an object Liquid or foreign matter gets inside the generator If you think the generator may have been damaged After setup is complete perform a Pre Treatment Vapor Cycl...

Page 43: ...the needle and pulling in and holding the vapor activation button When a treatment is in progress the time clock will count in whole seconds to the maximum preset treatment time After treatment time has elapsed the generator will automatically end the treatment and will once again be ready for treatment Releasing and reactivating the vapor activation button will initiate another treatment after th...

Page 44: ...d between treatments is in effect etc the screen specified Waiting as depicted below and is grayed out The generator will automatically be ready for treatment Figure 15 when the pending condition is resolved Monitor the ALERTS message area during treatment and take action when specified to do so Figure 17 Pending Ready Indicator on screen ...

Page 45: ...ton Treatments will not be performed during this mode When visualization has been cleared turn off Turbo Flush by releasing the button 3 1 4 2 Connecting New Delivery Device during treatment session The generator can detect if a new delivery device has been connected to the generator during a therapy session If a new Delivery Device is connected during the therapy session select New to create a ne...

Page 46: ... Section 9 Turn on again to restart the generator to begin a new therapy session CAUTION Before moving this generator turn the power OFF remove all accessories from the patient and unplug the power cord from the outlet 1 Turn off the generator by pushing the bottom Power button located on the front of the generator Power button Figure 19 Power button Note In the event of loss of power a new patien...

Page 47: ...enu Items To configure the generator and setup before the therapy session begins select the Options button on the lower toolbar Figure 20 Options Menu button The following options if applicable are available and described in further detail in the sections below Figure 21 Options Menu choices ...

Page 48: ...ring or after the therapy session When a new Delivery Device is connected a blank patient record is automatically created The Patient Info screen allows data entry The data is saved whenever the cursor enters another field or when you leave the screen The Doctor field will allow for selection from a drop down list of previous entries Figure 22 Patient Information Screen ...

Page 49: ...each pull down for an unknown value Months will be displayed using their equivalent three letter abbreviations ID Field can store up to 50 characters Field can store alphanumeric and symbols Field can store upper or lower case characters Study ID Field can store up to 50 characters Field can store alphanumeric and symbols Field can store upper or lower case characters Doctor Field can store up to ...

Page 50: ...e from field to field select the Tab button Shift To switch between upper case and lower case toggle using the Shift button Back Arrow To delete text touch the space after the character you d like to delete to move the cursor to that position Press the back arrow Enter To enter a selection select Enter 123 The 123 button allows access to the full Qwerty keyboard Select this button to show all avai...

Page 51: ...Confirm Bladder Drain dialog box shall appear when Drain Bladder is selected Select Confirm to confirm the physician has done so Figure 24 Drain Bladder Confirmation 3 1 6 3 Replace Saline When saline is replaced select the Replace Saline from the Options Menu and select the appropriate size saline from the available options The saline source volume will be set to the previously selected value upo...

Page 52: ... shall be released If the user selects Cancel no action shall be taken Figure 26 Remove Device If the Delivery Device is primed and a release syringe operation occurs then the Delivery Device shall require re priming before treatments can be resumed After the device is removed patient information will be displayed From this screen patient information procedure summary and options to continue compl...

Page 53: ...with HIPAA In this screen you may select a patient record stored within the system for deleting viewing and editing Figure 28 List of Patient Records Screen Patient records can be selected by pressing the desired record row or Select All button They can be deselected by pressing a selected row or the Deselect All button The box will be highlighted blue when selected and gray when deselected Refer ...

Page 54: ...delete patient therapy records The generator does not automatically delete records To delete one or more records select the desired patient records to be deleted by pressing the desired record row or Select All button Next select the Delete button at the bottom of the screen You will be prompted with a Delete selected record s dialog box to confirm deletion Figure 30 Delete Patient Records If sure...

Page 55: ...en will display the selected patient record This screen is not editable You may select the Edit Patient Info button at the bottom of the screen to edit the patient data via the Patient Info screen You can also export the displayed record by selecting the Export Record button Figure 31 View Record Screen ...

Page 56: ...rsonnel or to export treatment data This option is used to export selected records Password protection is available via the Set Records Password button in the System Status screen to ensure patient privacy is maintained Therapy and patient information can be exported to a USB memory stick Touch the desired folder to select the location on the USB drive to export the records Touch Save to export th...

Page 57: ...evision D January 2018 NxThera 2018 Page 57 of 90 When the records are properly transferred to the USB memory stick a confirmation message will be displayed on the screen Figure 34 Export Patient Records Success ...

Page 58: ... details of individual treatments stored in that record Figure 36 Specifically each comma separated line of data contains patient ID serial number of the Delivery Device treatment start date time stamp treatment duration Figure 35 Example of Exported Patient txt File Patient Id Serial Number Date Time Treatment Time 123456 D2200 1001 16 09 17 12 29 9 123456 D2200 1001 16 09 17 12 29 9 123456 D2200...

Page 59: ...n allows the 5 options that can be selected Figure 37 More Options Screen 3 1 6 6 1 System Status The System Status screen contains information Information on the generator and Delivery Device internal device identifiers Software versions Ability to set date and time Ability to set language Ability to set records password Figure 38 System Status ...

Page 60: ...t saving time changes The generator does not automatically adjust for daylight savings time changes Valid dates are between 1900 and the current year Figure 39 Set Date and Time 3 1 6 6 1 2 Set Language The Set Language screen allows the language to be updated from English to preloaded language options and desired number format These settings do not change when powering on and off the generator Fi...

Page 61: ...age Selections 3 1 6 6 1 3 Set Records Password The Set Records Password screen allows password protection to ensure patient privacy is maintained Passwords can be changed via the Set Records Password screen If a password is forgotten contact NxThera to reset Figure 42 Set Records Password After the password has been successfully changed or cleared a Success confirmation is displayed Select OK to ...

Page 62: ...3033 001 Revision D January 2018 NxThera 2018 Page 62 of 90 Figure 43 Set Records Password Success Figure 44 Passwords cleared successfully ...

Page 63: ...3033 001 Revision D January 2018 NxThera 2018 Page 63 of 90 If passwords do not match an error will be displayed indicating the passwords do not match Figure 45 Passwords do not match ...

Page 64: ...he generator CAUTION The Rezūm Generator USB port is only intended for use during maintenance by authorized service personnel or to export treatment data Encrypted log files can be exported to a USB drive for use by NxThera service personal only Select files to export from the list of options and Click OK Figure 46 Select Files to Export Figure 47 Reading Files ...

Page 65: ... 2018 NxThera 2018 Page 65 of 90 Select export path and select Save Figure 48 Reading Files After saving the files the generator will build the archive export the files and prompt when it is successful Figure 49 Building archive ...

Page 66: ...3 1 6 6 3 Treatment Monitor This screen is password protected and accessed by NxThera service personal only 3 1 6 6 4 Treatment Config This screen is password protected and accessed by NxThera service personal only 3 1 6 6 5 Servicing This screen is password protected and accessed by NxThera service personal only ...

Page 67: ...h a patient WARNING Do not modify this equipment without authorization of NxThera WARNING If this equipment is modified with authorization from NxThera appropriate inspection and testing must be conducted to ensure continued safe use of the equipment CAUTION When any of the following occur turn the power off remove all accessories from the patient and unplug the power cord from the outlet There is...

Page 68: ...To prevent damage to generator do not clean any part of the device with phenolic compounds Do not use abrasive or flammable cleaning agents Do not steam autoclave or gas sterilize the generator CAUTION Using this generator with the ventilation ports blocked could cause a breakdown Clean this generator with care CAUTION Only NxThera approved equipment and accessories shall be connected to the gener...

Page 69: ...all NxThera Customer service The generator should be carefully inspected prior to installation use and each time the equipment is serviced Carefully inspect the generator case for stress or physical damage Inspect all external connections for loose connectors Inspect all external cables for damage or cracking Inspect the display for marks scratches or other damage Verify that the Product label on ...

Page 70: ...CAUTION When using disinfectant solutions follow the manufacturer s directions CAUTION Using this generator with the air vent blocked could cause a breakdown Clean this generator with care CAUTION To prevent damage to equipment do not clean any part of the generator with phenolic compounds Do not use abrasive or flammable cleaning agents Do not steam autoclave or gas sterilize the generator 4 1 2 ...

Page 71: ...tly dampened with water or 70 isopropyl alcohol Super Sani Cloth wipes and Cidex may be used per manufacturer instructions To prevent scratching the display the use of a soft cloth is recommended 3 When cleaning do not immerse 4 Wring any excess moisture from the cloth before and during cleaning 5 Avoid pouring fluids on the generator and do not allow fluids to penetrate the exterior surfaces of t...

Page 72: ...cates to not use take the generator out of service and call NxThera Customer Service Carefully inspect the generator case for stress or physical damage Inspect all external connections for loose connectors Inspect all external cables for damage or cracking Inspect the display for marks scratches or other damage Verify that the Safety label on the device is clearly legible and present Operating Tes...

Page 73: ... is damaged is not functioning properly or fails to meet an electrical safety check Notify the appropriate personnel to ensure the generator is removed from service and properly repaired The generator has no user serviceable internal components Try to resolve any maintenance issues with the generator by using the Troubleshooting Table presented in Section 6 Troubleshooting If you are unable to res...

Page 74: ...3033 001 Revision D January 2018 NxThera 2018 Page 74 of 90 Chapter 5 Technical Specifications Overview This chapter contains specifications for the Rezūm Generator and EMC information ...

Page 75: ...it should be allowed to warm up to the needed operating temperature before using Description Specification Protection against Electric Shock Class I Equipment generator Model Number G2200 100 240 VAC 50 60Hz Power Input 10 Amps maximum External Fuses Two 10AH 250V 5x20mm Mode of Operation Continuous Operation System Control Provides controlled flow of water vapor at ambient temperatures below 25 C...

Page 76: ...5 C 10 85 RH non condensing 70kPa to 106kPa Storage Conditions Temperature Humidity Pressure Prevent from freezing 10 C 40 C See USP Controlled Room Temperature 10 85 RH non condensing 70kPa to 106kPa Transportation Temperature Humidity Pressure for up to 72 hours 29 C 60 C 10 85 RH non condensing 70kPa to 106kPa Table 13 Operating Storage and Transportation Specifications ...

Page 77: ... EMC information provided in Chapter 5 of this document CAUTION Use of portable and mobile RF communications equipment near the Rezūm Generator may affect its operation CAUTION Observe the following cautions when connecting this generator with other equipment Ensure that the connected equipment is in accordance with the IEC60601 1 or IEC safety standards Employ additional protective measures e g a...

Page 78: ...nment guidance Radiated emissions CISPR 11 2015 Group 2 The Rezūm Generator uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Conducted emissions CISPR 11 2015 Class A The Rezūm Generator is suitable for use in all establishments other than domestic and those directly connected to the pu...

Page 79: ...ld be at least 30 Electrical fast transient burst immunity IEC 61000 4 4 2012 1 kV common mode 5kHz and 100kHz Mains power quality should be that of a typical commercial or hospital environment Surge immunity IEC 61000 4 5 2014 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Power frequency magnetic field IEC 61000 4 8 2009...

Page 80: ...at 100 60 30 voltage reduction one interrupt Three 100 dips each at phase angles of 0 45 90 135 180 225 270 and 315 one interrupt Mains power quality should be that of a typical commercial or hospital environment If the user of the Rezūm Generator requires continued operation during power mains interruptions it is recommended that the Rezūm Generator be powered from an uninterruptible power supply...

Page 81: ...luding cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 P d 1 2 P 80 MHz to 800 MHz d 2 3 P 800 MHz to 2 57GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and is the recommended separation distance in meters m b Fiel...

Page 82: ...onment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Rezūm Generator is used exceeds the applicable RF compliance level above the Rezūm Generator should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the R...

Page 83: ... At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 to 40 70 MHz NOTE 3 An additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in the ISM frequency...

Page 84: ...er to the Electromagnetic Immunity information in Chapter 5 WARNING The generator needs special precautions regarding Electromagnetic Compatibility EMC and needs to be put into service according to the EMC information in Chapter 5 provided in this operator s manual CAUTION The generator conforms to the requirements of the EMC standard IEC 60601 1 2 2009 However it may be affected by electrical sca...

Page 85: ...vision D January 2018 NxThera 2018 Page 85 of 90 Chapter 6 Troubleshooting Overview This chapter contains troubleshooting steps error message description error message table and how to obtain technical assistance ...

Page 86: ...you experience a problem while using the generator please use the Error Message table to troubleshoot the issues If you are unable to correct it write down the error message and error code if applicable and contact qualified service personnel in your institution or contact Customer Service ...

Page 87: ...of 90 6 2 Error Messages Error messages will be displayed on the screen There are 2 types of error messages Error and Critical Error Error Message Error message Figure 52 Example Error Message Critical Error message Figure 53 Example Critical Error Message ...

Page 88: ...sure Self Test Error Power off on the Generator If problem persists contact Technical Support 470 Generator Error Delivery Device Temperature Excessive Retract the needle and remove the Delivery Device from patient Power off on the Generator Replace Delivery Device 475 Generator Error Software Compatibility Self Test Error Power off on the Generator If problem persists contact Technical Support 48...

Page 89: ...Treatment Check syringe and water line for bubbles or leaks If bubbles are found replace syringe and reprime Delivery Device If leaks are found replace Delivery Device If no bubbles or leaks are observed replace Delivery Device 243 Pre Treatment Failed High Water Pressure Pre Treatment Check water line for kinks Resume pre treatment vapor cycle If problem persists replace Delivery Device 245 Prime...

Page 90: ...Saline Pump Encoder Error Ensure Delivery Device saline flush line is correctly inserted into saline pump and pump door is closed If problem persists contact Technical Support 325 Confirm Bladder Drain Saline Instilled Limit Exceeded Saline instilled limit exceeded Please confirm the physician has drained the bladder 341 Prime Paused RF Power Tolerance Limit Exceeded Wait for RF Power Supply reset...

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