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1 General X-Ray System Presentation From: Abex Medical System Sdn Bhd (Toshiba Medical Equipment sole distributor)  Site preparation  Licensing procedure-

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Presentation on theme: "1 General X-Ray System Presentation From: Abex Medical System Sdn Bhd (Toshiba Medical Equipment sole distributor)  Site preparation  Licensing procedure-"— Presentation transcript:

1 1 General X-Ray System Presentation From: Abex Medical System Sdn Bhd (Toshiba Medical Equipment sole distributor)  Site preparation  Licensing procedure- Membeli & Menstor  Licensing procedure – Mengguna  Licensing procedure – Maintaining Mengguna

2 2 What are the Government, KKM requirement for site preparation  X-ray Room Size (Refer next page for different combination.)  Dark Room Size ( Minimum size:1.5 meter X 2.0 meter)  Radiation protection for Wall of the room: Must at least 2 mm Pb eq. (brick wall or lead lining wall).  Radiation protection for window and doors: Must be at least 2 mm Pb eq. Lead glass for window and 2 mm Pb eq. Lead lining door and door frame.  Others: Target board direction, X-ray room position and etc.

3 3 Minimum X-Ray Room Size KKM requirement  Control inside with table: 3 meter X 5 meter  Control inside without table: 2.5 meter X 4 meter  Control outside with table: 2.5 meter X 4 meter  Control outside without table: 2.5 meter X 3.5 meter

4 4 Example-Typical room design 2500mm 4000 mm 2500mm 4000 mm

5 5 What are the license need to apply for the user?  By Customer  “License Membeli dan Menstor” – Before installation  “License Mengguna” – After installation  By Supplier  “License Import” and “License Memasang” – Before installation

6 6 How to apply License Membeli & Menstor Sales order confirmation Submit Document to LPTA - Room and clinic layout plan - LPTA/5A form (pink form) - Reply card - Copy of latest APC - RM15.00 for application fee - Cover letter Dr. Attend 1 week training -MINT Approval for Membeli & Menstor from KKM - Pay License Fee Apply Film Badge - MINT Start renovation Installation of X-Ray system

7 7 How to apply License Mengguna Complete installation & commissioning Verification by class H consultant Submit document to KKM - Original license & lampiran A - Cover letter - QC test certificate from Class H consultant - Class H certification summary report - Prove of film badge - Medical check-up report PG 16 - Training certificate License Menggguna Approved Start Operation

8 8 Maintaining Mengguna License  Daily Record book – patient name, IC No, Kv, Mas, body part,reject film (with reason).  Monthly Reject rate form, film badge renewal.

9 9 Maintaining Mengguna License Yearly Preparation 1. Service system by supplier. 2. Certification by class H license holder. 3. Attend CME course. 4. Audit film by Fomema. Document to submit yearly 1. RM fee 2. copy of current APC 3. Medical report Page Cover letter 5. Certification certificate and report 6. Film reject rate 7. CME certificate 8. 3 months MINT dos report 9. Audit film letter from Fomema

10 10 Maintaining Mengguna License Three year once (as per license validity) Preparation 1. Service system by supplier. 2. Certification by class H license holder. 3. Attend CME course. 4. Audit film by Fomema. Document to submit Three year once 1. RM License fee for 3 years 2. copy of current APC 3. Medical report Page Cover letter 5. Certification certificate and report 6. Film reject rate 7. CME certificate 8. 3 months MINT dos report 9. Audit film letter from Fomema 10. Original license & Lampiran A

11 11 THANK YOU From: Abex Medical System Sdn Bhd (Toshiba Medical Equipment sole distributor)


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