Certificatieniveaus en Eisen
Hieronder ziet u drie niveaus voor certificeringen. Groen, Pro, en Master.
De terminologie wordt hieronder verder beschreven.
Door op de corresponderende link te klikken zal u worden doorverwezen naar de corresponderende pagina, bijv. de Groen Certificerings Quiz (GCQ)
Trainerniveau; In staat andere beoefenaars te trainen. Geldig voor 1 jaar.
Tijdens de Beginner Training (BT) wordt de volgende kennis verstrekt:
- Introductie voor het bedrijf Reboocon Bionics B.V.
- Overzicht van het product Intuy Knee
- Service and Garantie
- Kader van Oplevering en Componentselectie
- Productaanpassingen en nieuws
- Menselijke pas en biomechanica
- Training van bewegingen
- Apparaatsignalen en opladen van batterij
- Intuy App - Mobile app for Intuy Knee
- Post-Market Surveillance en Waakzaamheid
- Trainingprogramma en Certificering
De Master Training (MT) focust zich op:
- Verrijkende kennis van het apparaat, zoals technieken voor het troubleshooten van problemen.
- Het bieden van support aan klanten
- Sales-geörienteerde kennis over het product
Right after the Beginner Training (BT), we will let the prosthetists get hand-on experiences with the IntelLeg device and the mobile app ILapp. We walk guide the prosthetist thru the patient fitting, step by step to ensure good understanding of the device and the app.
According to the latest regulation and international standard on Quality Mangement System (e.g. ISO 13485, cl. 7.5.3):
The organization shall document requirements for medical device installation and acceptance criteria for verification of installation, as appropriate.
If the agreed customer requirements allow installation of the medical device to be performed by an external party other than the organization or its supplier, the organization shall provide documented requirements for medical device installation and verification of installation.
Records of medical device installation and verification of installation performed by the organization or its supplier shall be maintained.
when a patient is fitted with our device, installation records and verification records need to be kept.
Therefore we made this Patient Fitting Record (PFR) form for convinience. It is an online form. When the patient fitting is done and patient taining is completed, please complete this form and send it to us.
After a prosthetist obtained the Green certification, he/she is allowed to fit patient indepependently within 3 months. To get to Pro level, the prosthetist is required is record his first independent patient fitting (IPF) according to the requirement specificed in this page.
To get to Master level from Pro level, the prosthetist is required to have completed successfully at least three IPFs.
IPF video recordings are sent to Reboocon Bionics using the online form at the bottom of the IPF page. Videos are then examined by the team of Reboocon Bionics according to a unified scoring system. The prosthetist is informed within 1 week whether he has passed the Patient Fitting Exam (PFE). Alternatively, this PFE can take place live, with Reboocon Bionics's team on site.
A Green Certification Quiz (GCQ) consists of about 30 questions. The questions are based on the contents of Beginner Trainning. A candidated is required to answer at least 90% of the questions correctly to pass the quiz. After attending the Beginner Training(BT) and passing the GCQ, the candidated is granted with Green Ceritificate.
The Master Certification Quiz(MCQ) is based on the contents of the Trainer Training (TT). More in-depth knowledge is checked.
A Master candidate is required to provide a simulated training to others (record a training presentation). All the key information that covered during the Beginner Training (BT) must be covered.
The presentation can be examined by a team of Reboocon Bionics B.V. on site or the recording of the presentation can be examined by Reboocon Bionics B.V. according to a unified scoring system. This is so called Master Qualification Exam (MQE).