ARISKA OKTAVERA

1914201057
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Medical tools

Medical devices are instruments, apparatus, machines and /

or implants that do not contain a drug used to prevent,
diagnose, cure and alleviate disease, caring for the sick,
restore health in humans, and / or forming the structure and
improve the function of the body. can be used in the body
through a surgical procedure or used outside the body.
 operated using a source of electrical energy or other energy sources other than
Medical Devices Active those generated directly by the human body or gravity; which works by changing
the energy. Medical devices that are intended to move the energy, substances or
other elements between an active medical device and the patient, without any
significant change, are not included as active medical devices.

Therapeutically active Active medical devices, which are used alone or in combination with other
medical devices medical devices to provide information to detect, diagnose, monitor or help deal
with physiological conditions, the level of health, disease, or congenital defects

Non-active medical Medical equipment that is operated using an energy source other than that used
devices in the active medical devices
 Medical devices that penetrate into the body as a whole or in
Invasive medical devices part, either through a body orifice or through the surface of
the body

Non medical devices Medical devices that do not penetrate into the body as a whole or in
invasif part, either through a body orifice or through the surface of the body.

duration of Use 1. Brief: use of medical devices continuously for less than 60 minutes
2. Short-term: the use of medical devices continuously from 60 minutes to 30
days
3. Long-term: the use of medical devices continuously over 30 days
 List of Medical Devices

Stethoscope Syringes (Injections) Thermometer tensimeter Manual Equipment Infusion Pulse Oximeter

Oxygen mask nebulizer Electrocardiograph (ECG)

Classification of Medical
Devices
Class risk Example

Film viewer, surgical instruments,

A Low risk gloves
surgical gloves, oxygen mask

B Low-Medium Risk Blood pressure cuff, steam sterilizer

C Medium-High Risk Patiet monitors, X-Ray Machine

D High risk Cardiovascular stents, pacemaker

Medical facility

Definition
Peraturan Pemerintah Republik Indonesia Nomor 47 Tahun 2016 About
the Health Care Facilities. Article 1 In this Government Regulation in
Health Care Facilities is a tool and / or premises used to organize
health care efforts, both promotive, preventive, curative and
rehabilitative undertaken by the Government, local government, and /
or community.
Health Care facilities for health
service delivery in the form of:

1. Individual health services; and / or

2. public health services.
Fasilitas Health Services has a service level
that consists of :
1. First-rate health care as referred to provide basic health services
2. The second level of health care as referred providing health
carespecialist.
3. The third level health care as referred providing health care
subspesialistik.
4. Health Care Facility second level and third level as intended can
provide the services provided by the Health Care Facilities
deeper levels.
 Type of Health Care
Facilities consist of

1. Medicals place independent practice; 6. units of blood transfusion;

2. community Health centers; 7. health laboratories;

3. clinic; 8. optical;

4. hospital; 9. medical care facilities for legal purposes

5. pharmacy; 10. Traditional health care.