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)
Beginnersniveau; Verplicht om naar Pro niveau the upgraden binnen 3 maanden.
- Beginner Training (BT)
- Patient Fitting Record (PFR)
- Guided Patient Fitting(GPF)
- Groene Certificeringsquiz (GCQ)
De meeste beoefenaars zullen op dit niveau moeten zitten. In staat om de prothese zelfstandig te plaatsen; Geldig voor 1 jaar.
- Geen aanvullende training t.o.v. Groen
- Patient Fitting Record (PFR)
- 1x Independent Patient Fitting(IPF)
- 1x Patient Fitting Exam(PFE)
Trainerniveau; In staat andere beoefenaars te trainen. Geldig voor 1 jaar.
- Master Training (MT)
- 2 more Patient Fitting Record (PFR)
- 2 more Indepedent Patient Fitting(IPF)
Master Qualification Practice (MQP)
- Master Certificeringsquiz (MCQ)
- 2 more Patient Fitting Exam(PFE)
Master Qualificatiexamen (MQE)
Attend the Beginner Training (BT, G1) ;
Watch or do a Guided Patient Fitting (GPF), with the supervision of a MASTER trainer;
Practice filling in the form Patient Fitting Record (PFR, G2);
Pass the Green Certificaiton Quiz (GCQ, G3);
- Tell us (GREEN request form, G4) .
- Perform an Independent Patient Fitting (IPF) by using the Patient Fitting Record (PFR) as a step-by-step guide.
- Submit the PFR form (P1). PLEASE DON'T forget this;
- Submit the pictures and videos required for Independent Patient Fitting (IPF, P2). Two options for uploading videos
- Upload videos directly, or
- Upload videos to Youtube or Vimeo (make sure the videos are 'Unlisted', not 'Public' or 'Private'), copy and paste Youtube/Vimeo links to the IPF submission form;
- PRO worden ceritifcate using P3.
- Attend the Master Training (MT, M1).
- Perform two more IPFs, and submit
- Perform and record the Beginner Training for Master Qualification Practice (MQP),
- upload the video to Youtube or Vimeo ( make sure the videos are 'Unlisted', not 'Public' or 'Private'), and
- send the video link using MQP form (M4).
- Pass the Master Certification Quiz (MCQ, M5).
- MASTER worden certificate using the button M6.
- Request portal accounts for the trainees 2 workdays before the Beginner Training, using the helpdesk (Type of ticket: Portal Account);
- Perform the training and GPF, and let the trainee practice PFR;
- Let the trainee finish the GCQ before the end of the training;
- Ask the trainee to Request GREEN certificate using the "Vertel ons" button.
- Let the trainee perform an IPF. And to finish the PFE, the MASTER have two options:
- On site: The MASTER observes the trainee's IPF and the MASTER performs the exam using the form PFE;
- Remotely: Let the trainnee perform the IPF and upload pictures and videos using the IPF form. Once the files are uploaded, our certification team will receive a helpdesk ticket and will give the MASTER permission to see the IPF pictures/ videos (by adding the MASTER as the follower of the helpdesk ticket), and then the MASTER can check the files and perform the exam using the form PFE.
- REMEMBER: It is the MASTER who is allowed to do PFE, not the trainee.
- After the IPF/PFE, ask the trainee to Request PRO Certificate using the button at the bottom of the PRO column.
How will the Certificate be issued?
- Our certification team will receive a helpdesk ticket if someone request a Certificate. Our certificate team will add the trainer (MASTER) as a follower of the ticket so that the trainer can see the progress and certificate.
- After receiving the certificate request, our certification team will check the evidences/ records (e.g. GCQ, PFR, or PFE).
- If complete, Reboocon Bionics issues the certificate directly. As the follower of the ticket, the MASTER/Trainer also receives the emails which contains the certificate.
- If the records are incomplete, we will inform the trainer and the trainnee to add the missing records and then we check again.
- All the certification requests are processed as Helpdesk Tickets. All the communication are done via emails. By replying to the ticket email, we keep each other informed.
Recertification will mostly be done remotely, in a format of webinar plus a quiz.
The goal of recertification is
- to refresh the knowledge, and
- to update the certificate holders about product changes and planned changes.
Sometimes, recertification can also take a physical format, where annual gathering of certificate holders will be held and on-site interaction will be possible.
All the hyperlinks on this page either bring you to a SURVEY form or a HELPDESK form.
- SURVEY: We use survey forms mainly for record keeping (e.g. PFR), and quizzes or exams (e.g. GCQ, MCQ, or PFE, MQE). Whenever you fill one, a record is generated in our system. We don't get a notification, if you want us to know, please use one of the other buttons to file a helpdesk ticket.
- HELPDESK: The form will lead to a helpdesk ticket. For example, IPF, MQP, "Tell us", "Request PRO", and "Request MASTER" will make a helpdesk ticket, and you will receive automatic confirmation emails. Our customer support team or certification team will get notified and reach out to you.
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 – the 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
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 make sure that this form is completed and sent to us.
The PFR also serves as a STEP-BY-STEP guide of patient fittings to the prosthetists. Prosthetist should use it and tick all the boxes when fitting Intuy Knee.
REMEMBER: PFR is MANDATORY for EVERY patient fitting, not just for certification.
Right after the Beginner Training (BT), we will let the prosthetists get hand-on experiences with the device and mobile app. We guide the prosthetist (trainee) thru the patient fitting, step by step to ensure good understanding of the device and the app.
After a prosthetist has obtained the GREEN certificate, 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, so meaning, two extra 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 PFE). 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 MASTER certificate holder (outside of Reboocon Bionics's team) can perform training and certification as well, he/she can use the PFE to evaluate the IPF of trainees. REMEMBER: It is the MASTER who is allowed to do PFE, not the trainee.
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 Master Training (MT) and the 3 patient fitting experiences of the Master candidate. 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).