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CZ1 - Fakultní Thomayerova nemocnice vbuzalka - Log out
Preferences Last connection: 2026-05-27 10:42:53

# CZ1-01

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

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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

The charge of the TWO Remote Controls was done correctly before the surgery (for 5 hours each) Yes
Describe the difficulty(ies) experienced and alternative or solution provided

### 1.2 Start procedure

All steps for the "Start procedure" of the two Remote Controls have been completed Yes

###

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

### 1.3 Pairing of the Remote Control with Control Unit

All steps for "Pairing procedure" of the Remote Control and the Control Unit have been completed Yes

###

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

### 2. Calibration procedure

All the steps of the 'Calibration procedure' have been completed Yes

###

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

## 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

###

LOT of the ARTUS® Cuff S
SN of the ARTUS® Control Unit
SN of the ARTUS® Remote Control

### 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

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