Boston Scientific rezum Series Manual Download Page 8

Page: 8 / 8

Boston S

cientific (Master Brand DFU

Template 8.2677in x 1

1.6929in

A4, 9223851

9A), eDFU

, MB, R

m, en, 50849555-0

Black (K) ∆E ≤5.0

EU Authorized

Representative

Boston Scientific Limited

Ballybrit Business Park

Galway

IRELAND

REP

Legal

Manufacturer

Boston Scientific Corporation

300 Boston Scientific Way

Marlborough, MA 01752

USA

USA Customer Service 888-272-1001

Recyclable

Package

Australian

Sponsor Address

Boston Scientific (Australia) Pty Ltd

PO Box 332

BOTANY

NSW 1455

Australia

Free Phone 1800 676 133

Free Fax 1800 836 666

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

Summary of Contents for rezum Series

Page 1: ...e exterior of the Sterile Water Vial is not sterile and should not be placed in the sterile field Positioning Saline Flush Line in Saline Pump Reference indicators on Generator to ensure Saline Flush Line is positioned in the correct direction If Saline Flush Line is placed in a backwards direction within the Saline Pump saline will not flow during procedure Remaining Saline Level in Bag Care shou...

Page 2: ...tray Topical antiseptic e g Betadine Patient drape Disposable underpads e g Chux Gauze squares Lidocaine gel anesthetic or water soluble lubricating gel Saline supply at room temperature 1 L 2 L 3 L 4 L 5 L or 500 ml IV pole for Saline supply 4 mm 30 degree 30 cm Storz or Richard Wolf rigid cystoscope lens Light source and cord Video camera and display recorder optional Drain bucket Hemostat Prepa...

Page 3: ...sh Line is placed in a backwards direction within the Saline Pump saline will not flow during procedure 5 Close Saline Pump door prior to attaching Saline Flush Line tip to the Saline bag Note If Saline Flush Line tip is attached to Saline bag prior to placing Saline Flush Line in the Saline Pump and closing the Saline Pump door saline may leak 6 Remove cap from tip of Saline Flush Line and attach...

Page 4: ...ry Device tip is proximal to the verumontanum and treat the bulk of the lateral lobe proximal to the verumontanum Advance the Delivery Device in 1 cm increments toward the bladder neck to deliver subsequent vapor treatments This may relax the tissue to allow the Delivery Device to reach the bladder neck If the Delivery Device still cannot reach the bladder neck treat the area that is proximal to t...

Page 5: ...he shaft to manually retract the proximal end of the needle into the shaft tip Fig 17 4 While maintaining the needle tip within the shaft remove Delivery Device from patient 5 If treatment is incomplete re start procedure with new Delivery Device and complete procedure 6 Report all incidences of manual needle retraction to Boston Scientific Customer Service Clean device and return to Boston Scient...

Page 6: ...Procedure or Device Related AEs Severity Resolved AEs Mild Moderate Severe Dysuria 17 14 4 0 97 Hematuria Gross 12 11 1 0 100 Hematospermia 6 6 1 0 100 Urinary Frequency 6 5 1 0 82 Decrease in Ejaculatory Volume 5 4 1 0 33 UTI Suspected 5 4 1 0 100 Urinary Retention 5 1 4 1 100 Urinary Urgency 5 3 2 0 78 Anejaculation 3 2 1 0 0 Terminal Dribbling 3 2 1 0 60 UTI Culture Proven 3 1 2 0 100 Epididymi...

Page 7: ... M006D2201 003 G2200 003 GTIN 08714729992547 GTIN 0855357006003 Responsible Party U S Contact Information Boston Scientific Corporation 300 Boston Scientific Way Marlborough MA 01752 508 382 9555 www bostonscientific com FCC Compliance Statement This device complies with Part 18 of the FCC Rules For further information see FCC web site for a complete description of all requirements WARRANTY Boston...

Page 8: ... REP Legal Manufacturer Boston Scientific Corporation 300 Boston Scientific Way Marlborough MA 01752 USA USA Customer Service 888 272 1001 Recyclable Package Australian Sponsor Address Boston Scientific Australia Pty Ltd PO Box 332 BOTANY NSW 1455 Australia Free Phone 1800 676 133 Free Fax 1800 836 666 AUS Do not use if package is damaged Argentina Local Contact ARG Para obtener información de con...

Search results

Summary of Contents for rezum Series

Reviews:

Brands by name

Popular brands

Boston Scientific rezum Series, Manual

Search results

Summary of Contents for rezum Series

Reviews:

Brands by name

Popular brands