2109100018L29 1608V002
5
Important information
2.5 Qualified personnel
Handling
Persons that operate the appliance are dentists
and dental personnel
As a result of their training and know-how, they
must ensure safe and appropriate handling
i
Each operator using the appliance must be
trained in its handling
Installation and repair
i
All installation, resetting, alteration, expansion,
and repair work must be carried out either by
Air Techniques personnel or by a suitably
qualified person approved by Air Techniques
2.6 Protection against electric
shock
i
When using the appliance, observe the rele-
vant electrical safety procedures
i
Never touch the patient and open connectors/
contacts of the appliance simultaneously
i
Damaged supply lines and connecting devices
must be replaced immediately
Pay attention to the EMC for medical prod-
ucts
i
Observe specific precautionary measures re-
lating to electromagnetic compatibility (EMC)
for medicinal products, see "14 Information
concerning EMC in accordance with
IEC 60601-1-2"
i
As a result of electromagnetic radiation or
ESD pulses, image artifacts can occur in the
images or the device may experience a mal-
function If necessary, restart the device, soft-
ware or computer
i
The appliance is designed for operation in
healthcare facilities (in accordance with IEC
60601-1-2) If the appliance is operated in an-
other environment, observe possible effects
on the electromagnetic compatibility
i
Do not use the device near HF surgical devic-
es and MRI equipment
i
Keep a minimum distance of 118 inch be-
tween the device and other electronical devic-
es
i
Keep a minimum distance of 118 inch be-
tween the appliance and mobile radio devices
i
Note that cable lengths and cable extensions
have effects on electromagnetic compatibility
2.3 General safety notes
US Federal law restricts this device to sale by or
on the order of a dentist or licensed practitioner
This device should be used only under the con-
tinued supervision of a dentist or licensed prac-
titioner
US-FDA Regulated Medical Device
i
When operating the appliance, be sure to ob-
serve all local guidelines, laws, rules and regu-
lations
i
Before each use check the function and con-
dition of the appliance
i
Do not convert or change the appliance in any
way
i
Observe the Installation and Operating In-
structions precisely
i
Keep the Installation and Operating Instruc-
tions in an accessible place so that the opera-
tor has instant access to them
2.4 Connecting appliances securely
Danger can arise when connecting appliances
to each other or to parts of systems (eg
through leakage currents)
i
Only connect appliances together when there
can be no danger to the operator or to the
patient
i
Only connect appliances when there can be
no environmental impairment through such in-
terconnection
i
If it is not clear from the appliance data sheets
that such connections can be safely made or
if you are in any doubt, always get a suitably
qualified person (eg the manufacturer) to ver-
ify that the setup is safe
i
Observe the relevant specifications of
IEC 60601-1 (EN 60601-1) when connecting
the appliance to other appliances,eg to a PC
system, both inside as well as outside the vi-
cinity of the patients
i
Only connect peripheral units (e g computer,
monitor, printer) which conform to
IEC 60950-1 (EN 60950-1) as a minimum
standard
EN
US
