Rez?m G2200 Operator's Manual
  1. Manuals
  2. Brands
  3. Rez?m Manuals
  4. Inverter
  5. G2200
  6. Operator's manual

Rez?m G2200 Operator's Manual

Hide thumbs
Table of Contents

Advertisement

Quick Links

Operator's Manual
Rezūm
®
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.
3033-001 Revision D January 2018
©NxThera 2018
Page 1 of 90

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the G2200 and is the answer not in the manual?

Questions and answers

Summary of Contents for Rez?m G2200

  • Page 1 Rezūm ® 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 This page intentionally left blank. 3033-001 Revision D January 2018 ©NxThera 2018 Page 2 of 90...

  • Page 3: Table Of Contents

    Table of Contents Chapter 1 About the Rezūm ® Generator ................... 6 Trademark and Copyright Information ..................7 Contact Information ........................7 Indications for Use/Intended Use and Contraindications ............. 8 Product Description ........................9 Safety ............................10 1.5.1 Dangers, Warnings and Cautions ..................10 1.5.1.1 DANGERS ........................
  • Page 4 3.1.4 Performing the Therapy ...................... 42 3.1.4.1 Turbo Flush ........................45 3.1.4.2 Connecting New Delivery Device during treatment session ........45 3.1.5 Turning off the Rezūm Generator ..................46 3.1.6 Rezūm Generator Options Menu Items ................47 3.1.6.1 Enter Patient Info ......................48 3.1.6.1.1 Using the On-screen Keyboard ................
  • Page 5 Generator Specifications ......................75 Operating, Storage, and Transportation Specifications ............76 Electromagnetic Compatibility Requirements ..............77 EN 60601-1-2 Compliance ...................... 84 Chapter 6 Troubleshooting........................ 85 Troubleshooting Steps ......................86 Error Messages .......................... 87 Error Message Table ......................... 88 Obtaining technical assistance ....................90 3033-001 Revision D January 2018 ©NxThera 2018 Page 5 of 90...

  • Page 6: Chapter 1 About The Rezūm ® Generator

    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. 3033-001 Revision D January 2018 ©NxThera 2018 Page 6 of 90...

  • Page 7: Trademark And Copyright Information

    1.1 Trademark and Copyright Information Rezūm is a registered trademark 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 www.nxthera.com Phone: +1-763-515-0404 Toll Free: +1-888-319-9691 Fax: +1-763-515-2085 Emergo Europe Prinsessegracht 20...

  • Page 8: Indications For Use/Intended Use And Contraindications

    1.3 Indications 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. 3033-001 Revision D January 2018 ©NxThera 2018 Page 8 of 90...

  • Page 9: Product Description

    1.4 Product Description The Rezūm generator is designed to heat the RF coil within the hand-held Delivery Device rapidly. The device uses radio frequency (RF) energy to heat water into vapor outside the body. The vapor is injected into the tissue and rapidly disperses through the interstitial spaces between the tissue cells.

  • Page 10: Safety

    1.5 Safety This section contains important safety information. NxThera requires that you read and understand all warnings, cautions, and the operator’s manual prior to using the Rezūm Generator. 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.

  • Page 11: Dangers

    1.5.1.1 DANGERS DANGER: Do not take or use the device in locations where combustible anesthetics or flammable gases are used or in high-pressure oxygen rooms or inside oxygen tents. 1.5.1.2 WARNINGS WARNING: A protective ground connection by way of the grounding conductor in the power cord is essential for safe operation.
  • Page 12 WARNINGS CONTINUED WARNING: Failure on the part of all responsible individuals, hospitals, or institutions, employing the use of Rezūm generator, to implement the recommended maintenance schedule may cause equipment failure and possible health hazards. The manufacturer does not, in any manner, assume the responsibility for performing the recommended maintenance schedule.

  • Page 13: Cautions

    WARNINGS CONTINUED WARNING: The Rezūm Generator is reusable, but is restricted to a single patient at a time for a therapy session. WARNING: To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. WARNING: Use a grounded AC outlet for the power supply and ground this generator.
  • Page 14 CAUTIONS CONTINUED CAUTION: Equipment operating in close proximity may emit strong electromagnetic or radio frequency interference (RFI), which could 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.
  • Page 15 CAUTIONS CONTINUED CAUTION: The Rezūm Generator cables may cause a trip hazard while cables are attached to the generator. CAUTION: The Rezūm Generator needs special precautions regarding Electromagnetic compatibility (EMC) and care should be taken in accordance to the EMC information provided in Chapter 5 of this document.

  • Page 16: Potential Adverse Events

    1.5.2 Potential Adverse Events The following adverse events have not been reported in the clinical trials: erectile dysfunction, pelvic abscess, rectal wall injury, and fistula. Delivering a form of thermal therapy or misuse 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.

  • Page 17: Symbols

    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 Title of symbol and Symbol Description of the Symbol Standard (reference number) Indicates on the rating plate that the...
  • Page 18 Title of symbol and Symbol Description of the Symbol Standard (reference number) Indicates the Authorized Authorized Representative in the ISO 15223-1:2016 representative in the European Union European Community (5.1.2) Indicates a medical device that can be broken or damaged if not handled carefully.
  • Page 19 Title of symbol and Symbol Description of the Symbol Standard (reference number) US Federal law restricts this device to FDA Register Vol. 81, Prescription device sale by or on the order of a physician. No. 115 (IIG, page 38919) Protection against Ingress of Solids IEC 60529 Non-protected IPx0...

  • Page 20: User Interface Symbols

    Title of symbol and Symbol Description of the Symbol Standard (reference number) Indicates the need for the user to consult the instructions for use for important cautionary information such ISO 15223-1:2016 Caution (5.4.4) as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself.

  • Page 21: Operator Training Requirements

    Symbol Description Generator question that requires user response Home screen menu Navigation buttons for back, forward, up and down Options Menu Volume Control Table 2: User Interface Symbols 1.6 Operator Training Requirements WARNING: The generator is not intended to be deployed in settings or situations that promote use by untrained personnel.

  • Page 22: Chapter 2 Getting Started

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

  • Page 23: Unpacking And Inspecting

    2.1 Unpacking and Inspecting CAUTION: Please use caution in opening the shipping box and try not to use sharp utility knives and such, as you risk cutting into yourself and/or product. Every attempt is made to ensure your order is accurate and complete. However, to be sure that your order is correct, verify the contents of the box against your packing slip.

  • Page 24: Generator Controls And Connections

    2.1.1 Generator Controls and Connections WARNING: The generator contains magnets in the LCD lid. Avoid close or prolonged contact with electrical devices or devices that have strong magnetic fields. WARNING: The Rezūm Generator is equipped with a USB port that is sensitive to ESD that may potentially result in injury or device failures.
  • Page 25 Figure 1: Front and Top of Generator Item Description Display Screen Touch screen display to provide system feedback to the user Syringe / Syringe Cradle Holds water for vapor treatment Electrical cable port The electrical cable is the RF energy line and the connections for the switches and thermocouples Roller pump Delivers saline during procedure...
  • Page 26 Figure 2: Back of Generator Figure 3: Side of Generator Description Item Grounding stud Grounding stud used for grounding product (Required in Europe) Air vent Outgoing air vent Product Label Provides information about the generator Fuse box Holds generator fuses Power cord plug Connection plug for electrical power cord Cover to protect display screen, syringe and pressure...

  • Page 27: Display Screen Map

    2.1.2 Display Screen Map The Rezūm Generator is equipped with a color touchscreen that can be viewed up to 8 feet away from the generator. The display allows interaction with the generator using screen buttons icons and menus with the touch of a finger with or without latex gloves. A-Title Bar B-Information Screen C-Lower Toolbar...

  • Page 28: Audible Tones

    2.1.3 Audible Tones The generator emits different audible tones to indicate to the user different events. These tones vary with the type of message and its content. The description of each tone is explained in Table 6. Tone Name Tone Description 1.

  • Page 29: Volume Control

    2.1.4 Volume Control The generator has an on-screen volume control as depicted in Figure 5. Figure 5: Volume Control Touch the minus symbol 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 ...

  • Page 30: Detachable Parts And Accessories

    2.1.5 Detachable Parts and Accessories WARNING: Use only NxThera approved and specified parts, accessories, optional parts, consumables, and components. CAUTION: The Rezūm Generator cables may cause a trip hazard while cables are attached to the generator. The Rezūm Generator has the following detachable parts and accessories: Detachable Parts –...

  • Page 31: Chapter 3 Using The Rezūm Generator

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

  • Page 32: Step By Step Instructions

    3.1 Step by Step Instructions This section contains step by step instruction on how to connect the power cord, turn on and off the generator, prime the delivery device, perform treatment, and use the option menu. WARNING: When transporting the generator, it is important to position it with the display facing away from the body.
  • Page 33 CAUTION: Equipment operating in close proximity may emit strong electromagnetic or radio frequency interference (RFI), which could 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.

  • Page 34: Connecting The Power Cord

    3.1.1 Connecting the Power Cord WARNING: Do not connect to an electrical outlet controlled by a wall switch because the generator may be accidentally turned off. WARNING: Do not plug power cord into an outlet (or unplug it) with wet hands. WARNING: Use only NxThera specified power cord.

  • Page 35: Turning On The Rezūm Generator

    3.1.2 Turning on the Rezūm Generator DANGER: Do not take or use the device in locations where combustible anesthetics or flammable gases are used or in high-pressure oxygen rooms or inside oxygen tents. WARNING: The Rezūm Generator is reusable, but is restricted to a single patient at a time for a therapy session.
  • Page 36 3. While the generator is powering up, it initially displays two start-up screens 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.
  • Page 37 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. 3033-001 Revision D January 2018 ©NxThera 2018 Page 37 of 90...
  • Page 38 5. After the Start-up Diagnostics are completed, 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.

  • Page 39: Priming The Delivery Device

    3.1.3 Priming the Delivery Device 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. ...
  • Page 40 Figure 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. 3033-001 Revision D January 2018 ©NxThera 2018 Page 40 of 90...
  • Page 41 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. 3033-001 Revision D January 2018 ©NxThera 2018 Page 41 of 90...

  • Page 42: Performing The Therapy

    3.1.4 Performing the Therapy WARNING: If the generator measurement readings or messages seem dubious or abnormal, check the condition of the patient first and stop using the generator. 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.
  • Page 43 After performing a pre-treatment vapor cycle, a screen will be displayed indicating the generator is ready for treatment. Figure 15: Ready for Treatment Screen A treatment is initiated by activating flush, deploying the needle, and pulling in and holding the vapor activation button.
  • Page 44 If at any time the generator is not ready to perform a treatment (e.g. rest period 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.

  • Page 45: Turbo Flush

    3.1.4.1 Turbo Flush If visualization becomes cloudy during the procedure, Turbo Flush can be activated to improve the visualization by increasing the saline flow rate. To activate Turbo Flush, press twice and hold vapor release button. Treatments will not be performed during this mode. When visualization has been cleared, turn off Turbo Flush by releasing the button.

  • Page 46: Turning Off The Rezūm Generator

    3.1.5 Turning off the Rezūm Generator 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. CAUTION: Before moving this generator, turn the power OFF, remove all accessories from the patient, and unplug the power cord from the outlet.

  • Page 47: Rezūm Generator Options Menu Items

    3.1.6 Rezūm Generator Options Menu 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 3033-001 Revision D January 2018...

  • Page 48: Enter Patient Info

    3.1.6.1 Enter Patient Info Patient information may be entered for reference or future retrieval at any time during 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.
  • Page 49 Field Description First Name • Field can store up to 50 characters. • Field can store alphanumeric and symbols. • Field can store upper or lower-case characters. Last Name • Field can store up to 50 characters. • Field can store alphanumeric and symbols. •...

  • Page 50: Using The On-Screen Keyboard

    3.1.6.1.1 Using the On-screen Keyboard To enter textual information from single words to paragraphs using the touchscreen, an On- screen QWERTY keyboard is automatically provided on screens that allow data entry. Touch the screen to place the cursor in a field. Figure 23: On-Screen Keyboard Layout Button Description...

  • Page 51: Drain Bladder

    3.1.6.2 Drain Bladder When 750ml of saline has been used, a message will be displayed to the physician to drain the bladder. When this has occurred, select from the Options Menu, Drain Bladder. A “Confirm Bladder Drain” dialog box shall appear when Drain Bladder is selected. Select Confirm to confirm the physician has done so.

  • Page 52: Remove Device

    3.1.6.4 Remove Device From the Options Menu, select Remove Device. A “Confirm Syringe Release” dialog box shall appear when Remove Device item is selected. If the user selects “Release”, then the syringe 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.

  • Page 53: View Patient Info

    3.1.6.5 View Patient Info This option is used to access all stored patient records. Password protection is available via the Set Records Password button in the System Status screen to ensure patient privacy is maintained and helps comply with HIPAA. In this screen you may select a patient record stored within the system for deleting, viewing and editing.

  • Page 54: Delete Record

    3.1.6.5.1 Delete Record The device will store up to a maximum of 1000 records. Once the generator reaches it maximum record capacity, it is necessary to export the records if desired and delete the record(s) in order to perform another therapy session. A password, if one has been established, shall be required to delete patient therapy records.

  • Page 55: View Record

    3.1.6.5.2 View Record The View Record screen 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.

  • Page 56: Export Record

    3.1.6.5.3 Export Record 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 maintenance by authorized service personnel 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.
  • Page 57 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 3033-001 Revision D January 2018 ©NxThera 2018 Page 57 of 90...
  • Page 58 The records are saved in both a .csv and .txt format. The date/time created and patient ID plus the patient first, last name, if available, are saved as the file name. The .txt file contains all the user-viewable information stored in the record (Figure 35). The .csv file contains details of individual treatments stored in that record (Figure 36).

  • Page 59: More Options

    3.1.6.6 More Options From the Options menu, select More Options. The More Options screen 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. ...
  • Page 60 3.1.6.6.1.1 Set Date and Time The Select New Date and Time screen allows the date and time of generator to be updated from factory defaults for time zone or daylight-saving time changes. The generator does not automatically adjust for daylight savings time changes. Valid dates are between 1900 and the current year.
  • Page 61 Select the desired language from the dropdown language list and click OK to change the language from English to desired language. Figure 41: Language Selections 3.1.6.6.1.3 Set Records Password The Set Records Password screen allows password protection to ensure patient privacy is maintained.
  • Page 62 Figure 43: Set Records Password Success Figure 44: Passwords cleared successfully 3033-001 Revision D January 2018 ©NxThera 2018 Page 62 of 90...
  • Page 63 If passwords do not match, an error will be displayed indicating the passwords do not match. Figure 45: Passwords do not match 3033-001 Revision D January 2018 ©NxThera 2018 Page 63 of 90...

  • Page 64: Export Logs

    3.1.6.6.2 Export Logs 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 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.
  • Page 65 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 3033-001 Revision D January 2018 ©NxThera 2018 Page 65 of 90...

  • Page 66: Treatment Monitor

    Figure 50: Exporting file Figure 51: Export Successful 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: Chapter 4 Maintenance And Service

    Chapter 4 Maintenance and Service Overview Proper maintenance of the Rezūm Generator is very simple, yet it is an important factor in its reliability. This section describes the maintenance and service required for the generator. WARNING: No modification of this equipment is allowed. Do not attempt to service or maintain the generator while in use with a patient.

  • Page 68: Recommended Maintenance And Care

    4.1 Recommended Maintenance and Care WARNING: Failure on the part of all responsible individuals, hospitals, or institutions, employing the use of Rezūm Generator, to implement the recommended maintenance schedule may cause equipment failure and possible health hazards. The manufacturer does not, in any manner, assume the responsibility for performing the recommended maintenance schedule.

  • Page 69: Visual Inspection

    4.1.1 Visual Inspection WARNING: After the visual inspection, if the device is damaged or a message indicating the generator is not to be used, take the generator out of service and call NxThera Customer service. The generator should be carefully inspected prior to installation, use, and each time the equipment is serviced.

  • Page 70: Cleaning The Rezūm Generator

    4.1.2 Cleaning the Rezūm Generator It is recommended that the generator be inspected after each use according to the Checklist in this manual and cleaned when appropriate. Listed below are recommendations for cleaning the generator. The generator does not need to be sterilized before or after use. WARNING: Do not submerge the device in liquids or pour cleaning liquids over, into or onto the generator.

  • Page 71: Cleaning Instructions

    4.1.2.3 Cleaning Instructions 1. Before cleaning the generator, turn the generator off and disconnect the power cord. 2. To remove any foreign material and fluid (e.g. dust, paper, etc.), wipe thoroughly with a soft cloth lightly dampened with water or 70% isopropyl alcohol. Super Sani-Cloth ®...

  • Page 72: Maintenance Checklist

    4.1.3 Maintenance Checklist Maintenance activities involve verifying operation and safety. Maintenance should always be performed by the Customer at least once every 12 months. The following checklist is recommended to be utilized when checking the generator: Visual Inspection WARNING: After the visual inspection, if the generator is damaged or a message indicates to not use, take the generator out of service and call NxThera Customer Service.

  • Page 73: Authorized Repair Service

    4.2 Authorized Repair Service WARNING: Shock Hazard - Do not open, disassemble, or alter the Rezūm Generator! Failure to observe this warning can result in personal injury or death. Refer maintenance issues to authorized service personnel. WARNING: Do not use the generator if it is damaged, is not functioning properly, or fails to meet an electrical safety check.

  • Page 74: Chapter 5 Technical Specifications

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

  • Page 75: Generator Specifications

    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...

  • Page 76: Operating, Storage, And Transportation Specifications

    5.2 Operating, Storage, and Transportation Specifications Operating Conditions 20˚C – 25˚C Temperature 10% – 85% RH (non-condensing) Humidity 70kPa to 106kPa Pressure Storage Conditions (Prevent from freezing.) -10˚C – 40˚C Temperature (See USP Controlled Room Temperature.) 10% – 85% RH (non-condensing) Humidity 70kPa to 106kPa Pressure...

  • Page 77: Electromagnetic Compatibility Requirements

    5.3 Electromagnetic Compatibility Requirements WARNING: Use of accessories other than those specified in this document may result in increased emission or decreased immunity of the Rezūm Generator. WARNING: The Rezūm Generator should not be used adjacent or stacked with other equipment and, if necessary, observe its operation to verify its normal operation during use.
  • Page 78 Table 14: Electromagnetic Emissions Guidance and manufacturer’s declaration – electromagnetic emissions The Rezūm Generator is intended for use in the electromagnetic environment specified below. The customer or the user of the Rezūm Generator should assure that it is used in such an environment. Electromagnetic environment –...
  • Page 79 Table 15: Electromagnetic Immunity Immunity Compliance Electromagnetic environment - guidance test level Electrostatic ±8 kV contact Floors should be wood, concrete or ceramic tile. If floors discharge are covered with synthetic material, the relative humidity (ESD) should be at least 30% ±15 kV air IEC 61000-4- 2:2008...
  • Page 80 Immunity Compliance Electromagnetic environment - guidance test level Voltage dips Six dips each at Mains power quality should be that of a typical commercial or hospital environment. If the user of the Rezūm 100%, 60%, 30% Generator requires continued operation during power interruptions voltage mains interruptions, it is recommended that the Rezūm...
  • Page 81 Table 16: Electromagnetic Immunity Guidance and manufacturer’s declaration – electromagnetic immunity The Rezūm Generator is intended for use in the electromagnetic environment specified below. The customer or the user of the Rezūm Generator should assure that it is used in such an environment.
  • Page 82 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. The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas.
  • Page 83 Rated maximum output 150 kHz to 80 80 MHz to 800 800 MHz to 2.7 GHz power of transmitter d = 2.3√P d = 1.2√P d = 1.2√P 0.01 0.12 0.12 0.23 0.38 0.38 0.73 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

  • Page 84: En 60601-1-2 Compliance

    5.4 EN 60601-1-2 Compliance 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: The generator should not be used adjacent to, or stacked with other equipment. If adjacent or stacked use is necessary, test the generator to verify normal operation.

  • Page 85: Chapter 6 Troubleshooting

    Chapter 6 Troubleshooting Overview This chapter contains troubleshooting steps, error message description, error message table, and how to obtain technical assistance. 3033-001 Revision D January 2018 ©NxThera 2018 Page 85 of 90...

  • Page 86: Troubleshooting Steps

    6.1 Troubleshooting Steps If 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: Error Messages

    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 3033-001 Revision D January 2018 ©NxThera 2018 Page 87 of 90...

  • Page 88: Error Message Table

    6.3 Error Message Table The following tables list all error messages that are displayed by the generator. Follow error message instructions to resolve the error. Code Error Title Error Cause Text Error Message Generator Error RF Power Supply Error Retract the needle and remove the Delivery Device from patient. Remove the Generator from service and contact Technical Support.
  • Page 89 Code Error Title Error Cause Text Error Message Faulty Delivery Unable to Read from Remove and reconnect Delivery Device electrical cable. If problem persists, Device Delivery Device Memory replace Delivery Device. Faulty Delivery Unable to Write to Remove and reconnect Delivery Device electrical cable. If problem persists, Device Delivery Device Memory replace Delivery Device.

  • Page 90: 3033-001 Revision D January 2018 ©Nxthera 2018

    Code Error Title Error Cause Text Error Message Prime Failed Syringe Water Fill Error Refill syringe and reprime Delivery Device. Treatment Halted Elevated Coil Temperature Partial treatment delivered. Check syringe and water line for bubbles or leaks. If no bubbles or leaks are found, resume treatment. If problem persists, replace Delivery Device.

Table of Contents