
Synthes 3
Specifications—System
The device complies with the following standards:
IEC 60601-1/60601-1/60601-1-2/60601-1-4
IEC 61000-6-1/61000-6-2/61000-6-3/6000-6-4
Medical Electrical Equipment
UL 60601-1
With regard to electrical shock, fire, mechanical hazards,
only in accordance with UL 60601-1 and CAN/CSA C22.2
No. 601.1
Environmental conditions
Operation Transportation
and storage
Temperature 10°–40°C –20°–50°C
50°–104°F –4°–122°F
Relative humidity 30%–75% 10%–75%
Atmospheric 500–1,060 hPA 500–1,060 hPA
pressure 0.5–1.06 bar 0.5–1.06 bar
Duty cycle
Intermittent operation X
sec on
Y
sec off
Cycles
Drill/Burr Attachments 30 30 unlimited
Reciprocating 30 60 5 cycles
Saw Attachment
Oscillating 25 60 5 cycles
Saw Attachment
Sagittal Saw Attachment 30 60 5 cycles
These recommendations for times of use for the attachments
for Electric Pen Drive have been determined under average
load with an ambient air temperature of 25°C (77°F).
Generally, electrical systems can heat up if in constant use.
For this reason, the duty cycle times listed above should be
followed to allow the Drive Unit and attachment to cool
down after constant use. If this is observed, the system will
avoid overheating and possibly harming the patient or user.
After the above indicated number of cycles, the respective
attachments must be allowed to cool down for 30 minutes.
The user is responsible for following the duty cycles indicated.
If longer periods of constant use are required, an additional
Drive Unit and/or attachment should be used.
Caution
– Carefully observe the above recommended duty cycles.
– Always use new cutting tools to prevent heating of the
system due to reduced cutting performance.
– For oral surgery, it is recommended to prevent any contact
of warm components with soft tissues as temperatures
even around 45°C may damage the lips and oral mucosa.
– Careful maintenance of the system will reduce heat
development in the Drive Unit and the attachments.
The use of the Synthes Maintenance Station (05.001.099)
is strongly recommended.
– The Electric Pen Drive should not be stored or operated in
an explosive atmosphere.