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

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

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. How to apply License Membeli & Menstor
Sales order confirmation
Installation of X-Ray system
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
Start renovation
Dr. Attend 1 week training -MINT
Approval for Membeli & Menstor from KKM - Pay License Fee
Apply Film Badge - MINT

7. How to apply License Mengguna
Start Operation
Complete installation & commissioning
License Menggguna Approved
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

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

9. Maintaining Mengguna License Yearly
Document to submit yearly
1. RM fee
2. copy of current APC
3. Medical report Page 16
4. 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
Preparation
1. Service system by supplier.
2. Certification by class H license holder.
3. Attend CME course.
4. Audit film by Fomema.

10. Maintaining Mengguna License Three year once (as per license validity)
Document to submit Three year once
1. RM License fee for 3 years
2. copy of current APC
3. Medical report Page 16
4. 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
Preparation
1. Service system by supplier.
2. Certification by class H license holder.
3. Attend CME course.
4. Audit film by Fomema.

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