Safety Notes
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General Information
en
3 General Information
Intended use The devices PG130/PG145 are multi-indication pumps with irrigation functions
for 4 indications:
• Laparoscopy
•Arthroscopy
•Hysteroscopy
•Urology
Each indication must be activated individually. Only activated indications can be
enabled. Activation is done with a special transponder (see Chapter 6.2 "Activat-
ing Indication on New Factory Devices").
The device PG145 is equipped with an additional vacuum function.
The devices themselves are non-invasive and designed for use in multi-unit racks
(non-sterile area). They pump medically sterile irrigation fluids (saline solution or
sorbitol/mannitol solution) through a sterile tube. These fluids are used to dis-
tend and irrigate corresponding body cavities to provide space or improve visibil-
ity for the attending physician. The optional suction function can be used to
siphon off secretions. The devices function only with the tube sets described in
the accessory list (see Chapter 20 "Article/Accessory List PG130/PG145"). The
transponder technology ensures safe and reliable use in the operating room and
the user is protected from accidental operating errors.
The devices may not be used to inject medication.
The devices are not designed or suitable for use with gas.
Essential performance The essential performance of the devices in the indication modes hysteroscopy,
urology, and arthroscopy is to dilate and maintain the dilation of a body cavity
with fluid. The dilation is here achieved via a pressure control.
The essential performance of the devices in laparoscopy mode is to provide an ir-
rigation flow.
Another essential performance of the device PG145 in all indication modes is to
provide suction pressure to suction the fluid from the patient.
WARNING!
Only physicians and surgical personnel with the required prior training in surgi-
cal applications may operate the devices PG130/PG145. Before the first use of
the device, they must be trained in how to use the equipment and must have
read the corresponding manual carefully and thoroughly.
3.1 Using the Laparoscopy Indication
Intended use: Laparoscopy The devices PG130/PG145 may serve as irrigation pump for use in minimally in-
vasive laparoscopic surgery (keyhole surgery). The optional suction function can
be used to siphon off secretions. The optional suction function can be used to ex-
tract and remove waste gas when using laser or RF surgical devices.
Contraindications The devices may not be used in the laparoscopy indication for surgical proce-
dures where a specific pressure must be preset and reached as required such as
during hysteroscopy, urology, and arthroscopy procedures, for example.
Technical application scope: Laparoscopy The following characteristics apply to the laparoscopy indication:
• The devices PG130/PG145 work with a permanently preset pressure of
500 mmHg when used in the laparoscopy indication.
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