TUR-SURGERYPressure Controlled

DOC No. 500_ENDOP638_NOV2014_100ex

Improve safety as a result of enhanced visibility during surgery

Reduce bleeding in TUR surgery2 with

41+Q41%

Reduce fluid consumption in TUR-P surgery1 & 2 with

28+Q28%

ENDO P® | System features

The pump can separately control inflow and outflow using two pump impellers. These are automatically controlled using novel software in ENDO P®, which separately controls flow and pressure in the operating area. Baseline settings are depending on the operation type selected by the user. By controlling both inflow and outflow, pressure and flow can separately be adjusted by the user via a foot pedal.

ENDO P® comprises the following components:ENDO P® device

A reusable, non-sterile footswitch

A reusable, non-sterile power cable

A reusable, non-sterile blood pressure cuff (ENDO BP™)

Consumables available for ENDO P® (sold separately):1. ENDO P® Patient Cassette including ENDO P®

Irrigation Tube

2. ENDO P® Day Cassette

3. ENDO P® Irrigation Tube

The sterile Patient Cassette is for single use and is supplied with a sterile Irrigation Tube. The sterile Day Cassette is for single use but can be used for one day. The sterile Irrigation Tube is supplied with the Patient Cassette and is also available separately.

Accessories for ENDO P® (sold separately):1. ENDO H® (non-sterile heater) including power

cable and communication cable for ENDO P®

2. EBI™ (non-sterile indicator for empty irrigation fluid bag) including power cable and communication cable for ENDO P®

New unique safety function:Bonvisi has now further improved ENDO P® with a warning function that alerts the user at any kind of leakage, mechanical or physical. The new function makes ENDO P® even more preventive against TUR syndrome and other risks, this is a unique function not available during gravity driven irrigation or in other endoscopic pumps.

ENDO P® provides fluid irrigation for cystoscopy procedures and TUR-P surgery.

Mechanical driven irrigation

Pressure settings based on blood pressure

When needed – individual control of flow and pressure

A

A

BB

C

C

In a controlled study ENDO P® reduced fluid consumption and bleeding vs gravity driven irrigation during TUR-P surgeries2

STUDY DESIGN

Fluid consumption

Patient groups Centers

REF South Hospital, Karolinska Institute, Sweden

NEW - ENDO P® Uddevalla Hospital, NU-Hospital Care, Sweden

1P-value Wilcoxon

265.15

113.37

0.0001

930=10=35=

347=900=

367=147=

250=0

146=249=

722=

REF

Total amount of fluid solution (ml) corrected for size of the prostate

When comparing to gravity irrigation & correlating for prostate size ENDO P®:

• Reduced bleeding with :

• Reduced fluid consumption with :Graphic relationship REF vs NEW - ENDO P®

Group NEW - ENDO P®

93N

Missing

Min

Median

Max

Mean

Std

25

35.00

900.00

1 0

347.22 249.33

722.22

146.34

367.28

147.88

Total amount of fluid solution (ml) / size of prostate

35=

265=113=

Bleeding

1P-value Wilcoxon

3.51

2.67

0.0151

940=0

560=400=

250=600=

500=

250=0

450=250=

110=

REF

Bleeding corrected for size of the prostate

Graphic relationship REF vs NEW - ENDO P®

Group NEW - ENDO P®

94N

Missing

Min

Median

Max

Mean

Std

25

0.56

25.00

0 0

4.18 2.74

11.78

0.45

5.91

5.08

Bleeding / size of prostate

351=267=

44+Q40.6%

28+Q27.8%

Bonvisi ABAugustendalsvägen 32131 52 NackaSweden

Phone: +46 (0)8 661 50 20Email: info@bonvisi.com

Web: bonvisi.com

ORDER INFORMATION

ENDO Pump Cassettes/ENDO Heater Cassette

ENDO Pump System Accessories

REF NUMBER PRODUCT COMMENTE5501010S ENDO P® (incl. 2-pedal foot control)E5551010 ENDO P® (excl. foot control)E5502020S ENDO H® (Heater) (incl. pump-interface cable)

E5502020 ENDO H® (Heater)

E5502030 ENDO BP™

E5502040 ENDO EBI™

E5502050 Foot control

REF NUMBER PRODUCT COMMENTD5401012 ENDO P® Day Cassette 20 units/box, 400 units/palletD5401014 ENDO P® Patient Cassette 20 units/box, 400 units/pallet

D5401016 ENDO P® Irrigation Tube 100 units/box, 2000 units/pallet

D5401025 ENDO H® Bag 10 units/box, 200 units/pallet

REF NUMBER PRODUCT A5502025 ENDO H® Power cable universalA5502035 ENDO BP Cable universal

For more information visit our website : www.bonvisi.com

1) Data on file; Bonvisi AB2) This is a summary of the report “Full Statistical Analysis July 2015, URO Endoscopic surgery comparing Gravity system and ENDO Pump System”. Study Identifier: ENDO 06-02, Mikael Åström, M. Sc., Ph.L., version 04, July 23, 2015.

© 2016 Bonvisi® AB DOC ID: 500-016, vers 2