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T CZ1 - Fakultní Thomayerova nemocnice vbuzalka - Log out
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CZ1-01 CZ1-02 CZ1-03 CZ1-04 CZ1-03-RE »

CZ1-01

H Date of birth : 05/1955 / Center : CZ1 - Fakultní Thomayerova nemocnice

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  • 1- CZ1-01 : Subject 
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4 V0 : Implantation Visit (or implantation attempt) - 28/02/2024

Date of surgery (or date of the attempt)  28/02/2024

Implantation

Has the patient been implanted with ARTUS®?  Yes
How many implantation attempts have there been? 
Please explain why and describe the difficulty(ies) experienced: 

1) Before starting the surgical procedure

The results of the 24-hour Pad Weight Test have been entered in the Baseline visit to validate the inclusion of the subject  Yes

Clinical Examination

Was the clinical examination performed  Yes

Vital sign measurements

Exam date  27/02/2024
Weight  114   kg
Body Mass Index  32.3   kg/cm²
Explain why clinical examination was not performed 

2) Preparation for surgical procedure

1. Device preparation

1.1 Charge of the Remote controls

1.2 Start procedure

1.3 Pairing of the Remote Control with Control Unit

2. Calibration procedure

2) Implantation procedure

At the end of procedure, material used

LOT of the ARTUS® Cuff S  22-0224
SN of the ARTUS® Control Unit  210011
SN of the ARTUS® Remote Control #1  052300185
SN of the ARTUS® Remote Control #2 

Material Back-up

The Back-up Material was used  No

1. Surgery

1.1 Duration of procedure

Beginning of the surgery, start of the incision (hh:mm)  10:00
End of the surgery, closure of the incision (hh:mm)  11:15

1.2 Anesthesia

What type of anesthesia performed ?  General

1.3 Foley catheter insertion

Size of Foley catheter used  14 CH

1.4 Dissection

Did a surgical dissection of the bulbospongiosus muscle has been performed? 

1.5 Cuff implantation

Locking Position of the cuff around the urethra  1
Tightening of the urethra 
If you have encountered difficulties, please describe the difficulty(ies) experienced and alternative or solution provided  no difficulties
Comment 

1.6 Surgery test procedure

All steps for the "Surgery Test procedure" have been completed  Yes

Describe the difficulty(ies) experienced and alternative or solution provided 
Comments 

1.7 Implantation of the Control Unit

All steps for the "Implantation of the control unit" have been completed  Yes

Describe the difficulty(ies) experienced and alternative or solution provided 
Comments 

1.8 Completion of implantation

All steps for the "Completion of implantation" have been completed  Yes

Describe the difficulty(ies) experienced and alternative or solution provided 
Comments 

1.9 Pictures of the final position of the Cuff around the urethra

Was a Picture of the Cuff final position around the urethra taken intra-operatively  Yes

1.10 Picture of the final position of the Control Unit

Was a Picture of the Control Unit final position taken intra-operatively  Yes

Pelvis radiography Front and Profil (to ensure proper positioning of the Control Unit implanted)

Radiography immediately post-surgical procedure

Was the Pelvis radiography performed?   Yes
Date of most recent pelvis radiography  04/03/2024

Usability Questionnaire Surgeon (Intra-operative)

Was the Usability Questionnaire Surgeon (intra-operative) performed  Yes
Explain why Usability Questionnaire Surgeon was not performed 

Artus® implantation

Concerning the implantation of the ARTUS device, do you agree with the following affirmations

1. The implantation of Artus® is technically simple  2 : Agree
2. The handling of the shell screwed on the end of the transmission cable is easy  2 : Agree
3. The cuff is easy to insert around the urethra  2 : Agree
4. Positioning the Cuff around the urethra is easy to perform  3 : Not sure
5. The Cuff loop around the urethra is easy to adjust  2 : Agree
6. The implantation technique of the Control Unit in the abdominal wall is easy to perform  2 : Agree
7. The fixing technique for the Control Unit in the abdominal wall is easy to perform  2 : Agree
8. The connection of the transmission cable and the Control Unit is easy to perform  2 : Agree

Using the remote control in operative period

Concerning the intraoperative use of the remote control, do you agree with the following affirmations

9. The remote control is easy to manipulate in the sterile bag  2 : Agree
10. The sequence to be carried out to reach the screen proposing the password to access the Physician interface is simple  2 : Agree
11. Matching between the Remote Control and the implanted Control Unit is easy to perform  2 : Agree
12. Visual evaluation of the correct operation of the device (Surgery mode) is easy to perform  2 : Agree
Do you have any comments regarding the intra-operative ARTUS implant and its use  No
Please complete your comment below 

Device deficiency

Device deficiency(ies) occurred during the procedure  No

Concomitant medications

Is the subject receiving any concomitant medication  Yes

Adverse events

Did new adverse event(s) occur since the informed consent signature  No
2024-03-05 19:55:53 : Created HanaFiserova Fiserová Hana
2024-03-06 21:06:19 : Modified HanaFiserova Fiserová Hana
2024-03-11 19:15:19 : Modified HanaFiserova Fiserová Hana
2024-03-11 19:17:01 : Modified HanaFiserova Fiserová Hana
2024-03-13 19:10:09 : Modified HanaFiserova Fiserová Hana
2024-03-21 14:38:35 : Modified HanaFiserova Fiserová Hana
2024-07-30 11:18:30 : Modified/ Signed HanaFiserova Fiserová Hana
2024-07-30 12:30:18 : Modified/ Accepted vbuzalka Buzalka Vladimir