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General X-Ray SystemPresentation

From:

Abex Medical System Sdn Bhd

(Toshiba Medical Equipment sole distributor)

Site preparation

Licensing procedure- Membeli & Menstor

Licensing procedure – Mengguna

Licensing procedure – Maintaining Mengguna

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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.

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Minimum X-Ray Room SizeKKM 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

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Example-Typical room design

2500mm

4000mm

2500mm

4000mm

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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

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How to apply License Membeli & MenstorSales 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

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How to apply License MenggunaComplete 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

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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.

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Maintaining Mengguna LicenseYearly

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 15.00 fee2. copy of current APC3. Medical report Page 164. Cover letter5. Certification certificate and report6. Film reject rate7. CME certificate8. 3 months MINT dos report9. Audit film letter from Fomema

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Maintaining Mengguna LicenseThree 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 once1. RM 300.00 License fee for 3 years2. copy of current APC3. Medical report Page 164. Cover letter5. Certification certificate and report6. Film reject rate7. CME certificate8. 3 months MINT dos report9. Audit film letter from Fomema10. Original license & Lampiran A

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THANK YOU

From:

Abex Medical System Sdn Bhd

(Toshiba Medical Equipment sole distributor)