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Initial commit — clean history (removed large test files, browser profiles, Medidata/Clario downloads)

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vladimir.buzalka
2026-06-01 15:36:31 +02:00
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DRY/screenshots_surgery/form_data.json
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{
"form_id": "10",
"patient_code": "CZ1-01",
"listing_cells": [
"CZ1-01",
"Male",
"Subject",
"16/02/2024",
"28/02/2024",
"17/04/2024",
"CZ1 - Fakultní Thomayerova nemocnice",
"VISIT0",
"V0 : Implantation Visit",
"0",
"1",
"1",
"",
"",
"",
"28/02/2024",
"Accepted",
"",
"",
"0",
"",
"0",
"",
"",
"1",
"Open",
""
],
"fields": [
{
"key": "Date of surgery (or date of the attempt)",
"value": "28/02/2024",
"valueClass": "valeur DTET0"
},
{
"key": "Has the patient been implanted with ARTUS®?",
"value": "Yes",
"valueClass": "valeur "
},
{
"key": "How many implantation attempts have there been?",
"value": null,
"valueClass": ""
},
{
"key": "Please explain why and describe the difficulty(ies) experienced:",
"value": null,
"valueClass": ""
},
{
"key": "The results of the 24-hour Pad Weight Test have been entered in the Baseline visit to validate the inclusion of the subject",
"value": "Yes",
"valueClass": "valeur "
},
{
"key": "Was the clinical examination performed",
"value": "Yes",
"valueClass": "valeur "
},
{
"key": "Exam date",
"value": "27/02/2024",
"valueClass": "valeur DTEEXAM"
},
{
"key": "Weight",
"value": "114   kg",
"valueClass": "valeur WGT"
},
{
"key": "Body Mass Index",
"value": "32.3   kg/cm²",
"valueClass": "valeur BMI"
},
{
"key": "Explain why clinical examination was not performed",
"value": null,
"valueClass": ""
},
{
"key": "The charge of the TWO Remote Controls was done correctly before the surgery (for 5 hours each)",
"value": "Yes",
"valueClass": "valeur "
},
{
"key": "Describe the difficulty(ies) experienced and alternative or solution provided",
"value": null,
"valueClass": ""
},
{
"key": "All steps for the \"Start procedure\" of the two Remote Controls have been completed",
"value": "Yes",
"valueClass": "valeur "
},
{
"key": "Describe the difficulty(ies) experienced and alternative or solution provided",
"value": null,
"valueClass": ""
},
{
"key": "Comments",
"value": null,
"valueClass": ""
},
{
"key": "All steps for \"Pairing procedure\" of the Remote Control and the Control Unit have been completed",
"value": "Yes",
"valueClass": "valeur "
},
{
"key": "Describe the difficulty(ies) experienced and alternative or solution provided",
"value": null,
"valueClass": ""
},
{
"key": "Comments",
"value": null,
"valueClass": ""
},
{
"key": "All the steps of the 'Calibration procedure' have been completed",
"value": "Yes",
"valueClass": "valeur "
},
{
"key": "Describe the difficulty(ies) experienced and alternative or solution provided",
"value": null,
"valueClass": ""
},
{
"key": "Comments",
"value": null,
"valueClass": ""
},
{
"key": "LOT of the ARTUS® Cuff S",
"value": "22-0224",
"valueClass": "valeur CUFF"
},
{
"key": "SN of the ARTUS® Control Unit",
"value": "210011",
"valueClass": "valeur CONTSN"
},
{
"key": "SN of the ARTUS® Remote Control #1",
"value": "052300185",
"valueClass": "valeur REMOSN"
},
{
"key": "SN of the ARTUS® Remote Control #2",
"value": null,
"valueClass": ""
},
{
"key": "The Back-up Material was used",
"value": "No",
"valueClass": "valeur "
},
{
"key": "LOT of the ARTUS® Cuff S",
"value": null,
"valueClass": ""
},
{
"key": "SN of the ARTUS® Control Unit",
"value": null,
"valueClass": ""
},
{
"key": "SN of the ARTUS® Remote Control",
"value": null,
"valueClass": ""
},
{
"key": "Beginning of the surgery, start of the incision (hh:mm)",
"value": "10:00",
"valueClass": "valeur START"
},
{
"key": "End of the surgery, closure of the incision (hh:mm)",
"value": "11:15",
"valueClass": "valeur STOP"
},
{
"key": "What type of anesthesia performed ?",
"value": "General",
"valueClass": "valeur "
},
{
"key": "Size of Foley catheter used",
"value": "14 CH",
"valueClass": "valeur "
},
{
"key": "Did a surgical dissection of the bulbospongiosus muscle has been performed?",
"value": null,
"valueClass": ""
},
{
"key": "Locking Position of the cuff around the urethra",
"value": "1",
"valueClass": "valeur "
},
{
"key": "Tightening of the urethra",
"value": null,
"valueClass": ""
},
{
"key": "If you have encountered difficulties, please describe the difficulty(ies) experienced and alternative or solution provided",
"value": "no difficulties",
"valueClass": "valeur ENCOUNT"
},
{
"key": "Comment",
"value": null,
"valueClass": ""
},
{
"key": "All steps for the \"Surgery Test procedure\" have been completed",
"value": "Yes",
"valueClass": "valeur "
},
{
"key": "Describe the difficulty(ies) experienced and alternative or solution provided",
"value": null,
"valueClass": ""
},
{
"key": "Comments",
"value": null,
"valueClass": ""
},
{
"key": "All steps for the \"Implantation of the control unit\" have been completed",
"value": "Yes",
"valueClass": "valeur "
},
{
"key": "Describe the difficulty(ies) experienced and alternative or solution provided",
"value": null,
"valueClass": ""
},
{
"key": "Comments",
"value": null,
"valueClass": ""
},
{
"key": "All steps for the \"Completion of implantation\" have been completed",
"value": "Yes",
"valueClass": "valeur "
},
{
"key": "Describe the difficulty(ies) experienced and alternative or solution provided",
"value": null,
"valueClass": ""
},
{
"key": "Comments",
"value": null,
"valueClass": ""
},
{
"key": "Was a Picture of the Cuff final position around the urethra taken intra-operatively",
"value": "Yes",
"valueClass": "valeur "
},
{
"key": "Was a Picture of the Control Unit final position taken intra-operatively",
"value": "Yes",
"valueClass": "valeur "
},
{
"key": "Was the Pelvis radiography performed?",
"value": "Yes",
"valueClass": "valeur "
},
{
"key": "Date of most recent pelvis radiography",
"value": "04/03/2024",
"valueClass": "valeur DTEPEL"
},
{
"key": "Was the Usability Questionnaire Surgeon (intra-operative) performed",
"value": "Yes",
"valueClass": "valeur "
},
{
"key": "Explain why Usability Questionnaire Surgeon was not performed",
"value": null,
"valueClass": ""
},
{
"key": "1. The implantation of Artus® is technically simple",
"value": "2 : Agree",
"valueClass": "valeur "
},
{
"key": "2. The handling of the shell screwed on the end of the transmission cable is easy",
"value": "2 : Agree",
"valueClass": "valeur "
},
{
"key": "3. The cuff is easy to insert around the urethra",
"value": "2 : Agree",
"valueClass": "valeur "
},
{
"key": "4. Positioning the Cuff around the urethra is easy to perform",
"value": "3 : Not sure",
"valueClass": "valeur "
},
{
"key": "5. The Cuff loop around the urethra is easy to adjust",
"value": "2 : Agree",
"valueClass": "valeur "
},
{
"key": "6. The implantation technique of the Control Unit in the abdominal wall is easy to perform",
"value": "2 : Agree",
"valueClass": "valeur "
},
{
"key": "7. The fixing technique for the Control Unit in the abdominal wall is easy to perform",
"value": "2 : Agree",
"valueClass": "valeur "
},
{
"key": "8. The connection of the transmission cable and the Control Unit is easy to perform",
"value": "2 : Agree",
"valueClass": "valeur "
},
{
"key": "9. The remote control is easy to manipulate in the sterile bag",
"value": "2 : Agree",
"valueClass": "valeur "
},
{
"key": "10. The sequence to be carried out to reach the screen proposing the password to access the Physician interface is simple",
"value": "2 : Agree",
"valueClass": "valeur "
},
{
"key": "11. Matching between the Remote Control and the implanted Control Unit is easy to perform",
"value": "2 : Agree",
"valueClass": "valeur "
},
{
"key": "12. Visual evaluation of the correct operation of the device (Surgery mode) is easy to perform",
"value": "2 : Agree",
"valueClass": "valeur "
},
{
"key": "Do you have any comments regarding the intra-operative ARTUS implant and its use",
"value": "No",
"valueClass": "valeur "
},
{
"key": "Please complete your comment below",
"value": null,
"valueClass": ""
},
{
"key": "Device deficiency(ies) occurred during the procedure",
"value": "No",
"valueClass": "valeur "
},
{
"key": "Is the subject receiving any concomitant medication",
"value": "Yes",
"valueClass": "valeur "
},
{
"key": "Did new adverse event(s) occur since the informed consent signature",
"value": "No",
"valueClass": "valeur "
}
]
}