2 +q28 - bonvisi · bonvisi ab augustendalsvägen 32 131 52 nacka sweden phone: +46 (0)8 661 50 20...
TRANSCRIPT
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: [email protected]
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