background image

7

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) ΔE ≤5.0 / CMYK Images

Figure 25: Release Syringe

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, 

Procedure Summary

 will be 

displayed. From this screen, 

Procedure Summary

 and 

Options

 

to 

Continue

Complete

 or 

Export

 are available.

Figure 26: Procedure Summary

Export Procedure Record

Precaution:

 Only approved equipment and accessories shall 

be connected to the generator.

Precaution:

 The Rez

ū

m™ Generator USB port is only intended 

for use by authorized service personnel or to export treatment 

data.

This option is used to export selected procedure records. 

Therapy information can be exported to a USB flash drive.
Touch the desired folder to select the location on the USB flash 

drive to export the procedure records. Touch 

Save

 to export the 

procedure records.

Figure 27: Export Procedure Records

Figure 28: Export Procedure Records Progress

When the records are properly transferred to the USB flash drive, a 

confirmation message will be displayed on the screen.

Figure 29: Export Procedure Records Success

The device will store up to a maximum of 1000 procedure records. 

Once the generator reaches it maximum record capacity, the 

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 procedure record 

(Figure 31). Specifically, each comma separated line of data 

contains: serial number of the Delivery Device, treatment start date/

time stamp, treatment duration.

Figure 30: Example of Exported .txt File

Figure 31: Example of Exported .csv File

More Options

From the Options Menu, select 

More Options.

 The 

More 

Options

 screen allows the 6 options that can be selected.

Figure 32: More Options Screen

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.

Figure 33: System Status

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.

Figure 34: Set Date and Time

Set Language

The 

Language Settings

 screen allows the language to be 

updated from English to preloaded language options and 

desired number format. These settings do not change when 

powering the generator ON and OFF.

Содержание rezum G2200-003

Страница 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...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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