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Boston Scientific rezum G2200-003, Manual, Page: 13 / 15

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Boston Scientific rezum G2200-003 Manual Download Page 13

13

Boston S

cientific (Master Brand DFU 

Template 8.2677in x 1

1.6929in 

A4, 9223851

9A), EOP MANUAL, MB, REZUM, EN, 51

230807

-0

1A

Black (K) ∆E ≤5.0

Code

Error Title

Error Cause Text

Error Message Instructions

246

Pre-Treatment Failed

High Temperature (Pre-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.

255

Treatment Halted

Low Temperature (Treatment)

Retract the needle and remove the Delivery Device from patient. Replace Delivery Device.

260

Treatment Halted

High Water Pressure (Treatment)

Check water line for kinks. Resume treatment. If problem persists, replace Delivery Device.

265

Treatment Halted

Low Water Pressure (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.

270

Syringe is Empty

Syringe Empty

Retract the needle and remove the Delivery Device from patient. Replace syringe and reprime Delivery Device.

275

Prime Failed

Syringe Water Fill Error

Refill syringe and reprime Delivery Device.

280

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. If bubbles are found, replace syringe 

and reprime Delivery Device. If leaks are found, replace Delivery Device.

290

Faulty Delivery Device

High Temperature (Idling)

Replace Delivery Device.

291

Faulty Delivery Device

High Water Pressure (Idling)

Replace Delivery Device.

295

Faulty Delivery Device

Needle Deployment Error

Ensure needle is retracted. Replace Delivery Device.

296

Faulty Delivery Device

Needle Retraction Error

Reattempt needle retraction. If problem persists, retract needle manually and replace Delivery Device.

300

Saline Pump Error

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.

 

Informational Error Messages

Table 14: Informational Error Message Table

Code

Error Title

Error Cause Text

Error Message Instructions

250

Prime Paused

Vapor Activation Button Released

Delivery Device button was released before priming completed. Press and hold Vapor Activation Button (blue) 

to continue priming.

251

Pre-Treatment  Paused

Vapor Activation Button Released

Delivery Device button was released before pre-treatment vapor cycle completed. Press and hold Vapor 

Activation Button (blue) to restart pretreatment vapor cycle.

341

Prime Paused

RF Power Tolerance Limit Exceeded

Wait for RF Power Supply reset to complete.

342

Pre-Treatment Paused

RF Power Tolerance Limit Exceeded

Wait for RF Power Supply reset to complete.

343

Treatment Halted

RF Power Tolerance Limit Exceeded

Wait for RF Power Supply reset to complete.

41000

Export Error

USB Drive Not Present or Invalid

Re-insert USB flash drive and try again. If problem persists, replace USB flash drive.

41002

Export Error

USB Drive Export Error

Insert a valid USB flash drive with sufficient available memory.

Note:

 The error message dialog boxes associated with errors 250 and 251 close when the user engages the Delivery Device vapor button. The error message dialog boxes associated with errors 341, 

342, and 343 close automatically when the RF Power Supply reset is complete.

Summary of Contents for rezum G2200-003

Page 1: ...igure 17 Treatment in Progress Screen 6 Figure 18 Pending Ready Indicator on Screen 6 Turbo Flush 6 Connecting New Delivery Device During Treatment Session 6 Figure 19 New Delivery Device 6 Turning Off the Rezūm Generator 6 Figure 20 Power Button 6 Rezūm Generator Options Menu Items 6 Figure 21 Options Menu Button 6 Figure 22 Options Menu Choices 6 Drain Bladder 6 Figure 23 Drain Bladder Confirmat...

Page 2: ...d adjacent to or stacked with other equipment If adjacent or stacked use is necessary test the generator to verify normal operation Refer to the Electromagnetic Immunity information Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm to any part of the Rezūm Generator including cables specified for use with the...

Page 3: ...ntrols 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 Warning Do not connect a grounding wire from a grounding stud to a gas pipe or water...

Page 4: ...r in the following locations Locations where gases and flames are used Locations where the air includes dust salt or sulfur Locations exposed to prolonged direct sunlight Locations that vibrate or are subject to sharp impacts Locations near heating equipment Locations where chemicals are stored This generator cannot be used in any room in which noise generating apparatuses are used such as an MRI ...

Page 5: ...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 will be displayed indicating when priming is complete If the vapor a...

Page 6: ...e to continue with current procedure record Figure 19 New Delivery Device 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 Turn on again to restart the generator to begin a new therapy session Precaution Before moving this gener...

Page 7: ...generator will automatically delete the oldest record to perform another therapy session The procedure records are saved in both a csv and txt format The serial number plus date time and unique number are saved as the file name The txt file contains all the user viewable information stored in the procedure record Figure 30 The csv file contains details of individual treatments stored in that proce...

Page 8: ...tions and click OK Figure 37 Select Files to Export Figure 38 Reading Files Select export path and select Save Figure 39 Export Files After saving the files the generator will build the archive export the files and prompt when it is successful Figure 40 Building Archive Figure 41 Exporting File Figure 42 Export Successful Procedure Summary The Procedure Summary screen displays a sortable list of r...

Page 9: ...quipment 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 Recommended Cleaning Products The following cleaning products may be used to clean the exterior surfaces of the generator Water 70 Isopropyl Alcohol Super Sani Cloth Germicidal Disposable Wipes by PDI only Not Recommended Cle...

Page 10: ...mmon mode 100kHZ Mains power quality should be that of a typical commercial or hospital environment Surge immunity EN IEC 61000 4 5 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 EN IEC 61000 4 8 30 A m 50 60 HZ Power frequency magnetic fields should be at levels characteristic of a typical l...

Page 11: ...crowave treatment devices and there may be an impact on measurement precision for patients using cardiac pacemakers and other similar devices Check the operation of this generator during and after use of the above mentioned equipment and with patients potentially affected ESSENTIAL PERFORMANCE The Rezūm System essential performance is defined as Enable visualization of intraurethral anatomy and tr...

Page 12: ...I Program Files Corrupted Power off on the Generator If problem persists contact Technical Support 35001 Generator Error Unexpected GUI Program Exit Power off on the Generator If problem persists contact Technical Support 35002 Generator Error Unable to Start GUI Program Power off on the Generator If problem persists contact Technical Support 40000 Generator Error GUI Unable to Communicate with MC...

Page 13: ...5 Faulty Delivery Device Needle Deployment Error Ensure needle is retracted Replace Delivery Device 296 Faulty Delivery Device Needle Retraction Error Reattempt needle retraction If problem persists retract needle manually and replace Delivery Device 300 Saline Pump Error Saline Pump Encoder Error Ensure Delivery Device saline flush line is correctly inserted into saline pump and pump door is clos...

Page 14: ...arranted Product or component furnished to address a warranty claim will be the longer of the unexpired term of the warranty applicable to the repaired or replaced Warranted Product or 90 days Boston Scientific warrants all Equipment that is loaned or otherwise remains the property of Boston Scientific as part of Boston Scientific s Agreement with the Customer Remedies If Customer promptly notifie...

Page 15: ... AUS Do not use if package is damaged Argentina Local Contact ARG Para obtener información de contacto de Boston Scientific Argentina SA por favor acceda al link www bostonscientific com arg Catalog Number REF EU Authorized Representative EC REP blue safety sign Follow Instructions For Use Contents Recyclable Package Australian Sponsor Address AUS Do not use if package is damaged Argentina Local C...

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