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PACE 203H – Instructions for Use
5I-17-016X-B-20
105 / 139
11.3 Safety Check-Ups of the
Pacemaker
In order to assure safe operation of
PACE 203H, the following check-ups
must be carried out on a regular basis.
Before each use
Visual inspection:
•
Inspect the device and accessories
for visible damage.
•
Inspect the connections for visible
damage.
Function test
•
Inspect all connections to see if they
affix and function properly.
•
Inspect all operating elements and
displays for perfect function.
After each use
•
Clean the device and its accessories
according to the instructions provided
in chapter 1.
Annual Functional and Safety Check
•
Measuring the auxiliary currents
•
Measuring the stimulation parame-
ters (amplitude, pulse width) in the
atrial and ventricular channels
•
Measuring the stimulation rate
•
Measuring the sensitivity in the atrial
and ventricular channel
•
Inspecting the battery surveillance
and measuring the power mainte-
nance time after removal of battery
•
Inspecting the lead surveillance.
•
Inspecting the runaway protection
Warning:
A repair or calibration made
by anyone except the manufacturer or a
manufacturer-authorized designee voids
the warranty of PACE 203H.
11.4 Product Return Policy
The European guideline 2002/96/EC on
waste electrical and electronic equip-
ment (WEEE directive) applies to the
return to the manufacturer and disposal
method of the PACE 203H as indicated
by the pictogram located on its back
(Figure 16).
Figure 16: Pictogram WEEE Guidelines
Devices which cannot be repaired can
be returned to the manufacturer, who
disposes the devices in accordance with
the WEEE guidelines.
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