Kowa Nonmyd 8S, Инструкция по эксплуатации, Страница: 9 / 60

VII
1. Electrical devices which constitute the KOWA nonmyd 8s system
This instrument constitutes a medical electric system by connecting with the following optional accessories or products.
- Numeric key pad (option)
In order to select internal fixation target in Mosaic, it is used connecting with USB connector of the KOWA nonmyd 8s.
- Personal computer
It is used in order to acquire the images taken by the KOWA nonmyd 8s. The application software was authorized
by KOWA (e.g. VK-2) should be installed on the PC.
LCD monitor or other peripheral equipment connected to the PC.
Numeric key pad can be installed in patient environment (within a radius of 1.5m around a patient).
When you install other electrical devices in patient environment, please use the below-mentioned “Multi-tap with Isolation
Transformer”. Do not touch the connector part of the instrument in the KOWA nonmyd 8s system and the patient
simultaneously.
2. Precautions for use of an electrical system
1) All components of this medical electrical system may be installed within a limited patient environment when all
components are installed in accordance with the installation instructions using “Multi-tap with Isolation Transformer”,
which is one of the system components.
2) As a prerequisite for installing to this system, other components (a PC, printer, video capture printer, video monitor,
or other devices) which do not comply with IEC 60601-1 (EN 60601-1) must be powered from “Multi-tap with
Isolation Transformer”. The electric power to these components supplied from an electric source other than “Multi-tap
with Isolation Transformer” (e.g., power outlets) may cause increased touch current or potential difference between
protective grounds resulting in the injury to the patient or operator. Use “Multi-tap with Isolation Transformer” only
for supplying the power to the components other than this instrument. And do not use “Multi-tap with Isolation
Transformer” in this system for supplying the power to any components other than this system.
3) Any medical electrical equipment that is connected to this system to compose a medical system must comply with
IEC 60601-1 (EN 60601-1).
4) Any non-medical electrical equipment that is connected to this system to compose a medical system must comply
with safety standards of IEC or ISO provisions applicable to such a non-medical electrical equipment.
5) Do not use any additional multi-tap or extension power supply cable other than those Kowa specified to this system.
6) Power supply to this system or “Multi-tap with Isolation Transformer” must be provided individually. (Do not route the
power supply through other multi-tap to the system or “Multi-tap with Isolation Transformer”.)
7) The power supply cable for electrical equipment that composes a medical system must have durability that meets
IEC 60245/IEC 60227 or higher standards.
8) Assure that the power supply is turned OFF when connecting other device to the system.
9) Do not turn ON the power supply until all devices are completely connected.
10) Do not place or install the devices and the system components on the unstable or inclined table.
3. Precautions for use of “Multi-tap with Isolation Transformer”
1) “Multi-tap with Isolation Transformer” should use the one equipped with the rated output more than power
consumption of equipment to connect.
2) Do not place “Multi-tap with Isolation Transformer” directly on the floor. Water droplets during room cleaning may
enter the multi-tap resulting in the component failure.
3) The power supply cable to “Multi-tap with Isolation Transformer” must be connected to a power receptacle with a
protective ground terminal equipotential to the protective ground of this instrument.
4) When using a “Multi-tap with Isolation Transformer” receptacle with a protective ground terminal, read the
instructions for use attached to the receptacle to familiarize yourself with the correct use before use.
4. Daily maintenance and cleaning
1) System components
• Wipe the outer surface with a firmly squeezed dampened soft cloth. Use mild detergent to remove excessive
soils. Do not use chemicals or solvents such as thinner or benzene. (As the LCD monitor screen cover easily gets
scratched, lightly wipe it with soft cloth such as gauze.)
• Refer to the instruction for use provided with each device for details of device maintenance and cleaning.
2) Power supply cables, connecting cables, and connectors
• Visually inspect that all cables have no flaw or damage.
• Visually verify that earth leads of all components and protective ground terminals are securely connected.
• Disconnect the power supply cables from the power supply receptacles when you do not use the system for a long
period of time.
3) Others
• When you change the components of this system, and connection after installing the system, you must build a
secure system according to the notes currently written here.
• When you add a PC to the system for an archiving purpose, captured images are stored in the HDD of the PC. Back
up the data stored in the HDD regularly since HDDs may have a mechanical or electrical failure.
Precautions: Use of Medical Electrical Systems