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NewTom VG User Manual rev 4.0 - Image Works

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Safety and maintenance of the device<br />

3.2 Guidelines for safety<br />

The device is not protected against liquid or gas infiltration. Liquid intrusion may damage the electrical parts<br />

and put the patient, the user and the environment in danger.<br />

Safety systems of the device do not decrease safety measures against the risk of fire in the place in which<br />

the device has been installed.<br />

Electrostatic discharge<br />

Electrostatic discharge may damage electrical parts in the device. Consequently the floor in the installation<br />

room should be made of antistatic materials.<br />

Extinguishers<br />

CO 2 extinguishers should be installed in an easily accessible area.<br />

X-Ray lamp<br />

It is possible for the user to install a x-ray lamp in order to signal the ready and emission states of the x-ray<br />

source.<br />

Door switches<br />

The system contemplates the possibility for the installation of an external switch that can stop the emission<br />

(typically installed on the entrance of the device room).<br />

Electromagnetic compatibility<br />

For information regarding the electromagnetic compatibility please refer to APPENDIX A:<br />

Reference.<br />

Technical<br />

3.3 Changes in the device<br />

Possible changes or updates for the system must comply with the laws in force.<br />

WARNING:<br />

It is forbidden to open or manumit the device with any tool.<br />

Whatever change (hardware or software) that was not p<strong>rev</strong>iously authorized is<br />

forbidden and can inhibit a proper working in the device. It may also damage the<br />

patient, the user, the device and the environment.<br />

Responsibility limits<br />

The manufacturer is not in charge for safety, reliability and performance features in the following<br />

cases:<br />

• Installation, maintenance, changes, repairs and/or updates were not performed by personnel<br />

that was not directly authorized by the manufacturer or distributor.<br />

• Replace parts were not approved by the manufacturer or distributor.<br />

• Environmental conditions were not conform according to the requirements of the laws in force<br />

and to the suggestions of a qualified expert.<br />

• The device is used in a way that is not corresponding to what is described inside this manual.<br />

Rev. 1.0 - 02/15/2009 Page 15 of 72

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