Technical Characteristics - Gima SUPER TOBI Manual Del Usuario

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6. The medical device requires special precautions regarding electromagnetic compatibility and must be

installed and used in accordance with the information provided with the accompanying documents: the

SUPER TOBI SUCTION UNIT device must be installed and used away from mobile and portable RF com-

munication devices (mobile phones, transceivers, etc.) that may interference with the said device.

7. WARNING: Do not change this equipment without the permission of the manufacturer GIMA S.p.A. None

of electric or mechanical parts has been designed to be repaired by customers or end-users. Don't open

the device, do not mishandle the electric / mechanical parts. Always contact technical assistance

8. Using the device in environmental conditions different than those indicated in this manual may harm seri-

ously the safety and the technical characteristics of the same.

9. The medical device is in contact with the patient by means of a disposable probe (not supplied with the

device). Suction tubes for insertion in the human body purchased separately from the machine should

comply with ISO 10993-1 standards on material biocompatibility.

10. The product and its parts are biocompatible in accordance with the requirements of regulation EN 60601-1.

11. Operation of the device is very simple and therefore no further explanations are required other than those

indicated in the following user manual.

12. Use in Home-Care: Keep all accessories of the device out of reach of children under 36 months of age

since they contain small parts that may be swallowed.

13. Do not leave the device unattended in places accessible to children and/or persons not in full possession

of mental facultiesas they may strangle themselves with the patient's tube and/or the power cable.

The manufacturer cannot be held liable for accidental or indirect damages should the device

be modified, repaired without authorization or should any of its component be damaged due to ac-

cident or misuse. Any minimal modification / repair on the device voids the warranty and does not

guarantee the compliance with the technical requirements provided by the MDD 93/42/EEC (and sub-

sequent changes) and its normatives.

CONTRAINDICATIONS

- Before using the SUPER TOBI, consult the instructions for use: failure to read all the instructions in this

manual can be harmful for the patient.

- The device cannot be used to drain chest fluids;

- The device must not be used for suction of explosive, corrosive or easily flammable liquids.

- SUPER TOBI is not suitable for MRI. Do not introduce the device in MRI environments.