Warnings And Precautions; General - CooperSurgical Endosee Benutzerhandbuch

Endosee ® Hysteroscope - User Manual
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Warnings and Precautions

This section contains important safety information related to
use of the Endosee Hysteroscope and the cannula. Other
important safety information is repeated throughout this
manual in sections that relate specifically to the precautionary
information. Read all text surrounding all warning and
precautionary information prior to performing any procedures
with this equipment.

2.1 General

• Federal Law (USA) restricts the device to sale by
or on the order of a physician.
• The Endosee Hysteroscope with the cannula is
intended only as an adjunct in patient assessment.
It must be used in conjunction with clinical signs
and symptoms.
• The Endosee Hysteroscope with the cannula is for
use only by physicians with adequate training
in hysteroscopy.
• When a liquid distension medium is used, strict
fluid intake and output surveillance should be
maintained. Intrauterine instillation exceeding
1 liter should be followed with great care to
reduce the possibility of fluid overload.
• Potential complications of continuous
flow hysteroscopy:
- Hyponatremia
- Hypothermia
- Uterine perforation resulting in possible injury
to bowel, bladder, major blood vessels
and ureter
- Pulmonary edema
- Cerebral edema
- Infection
- Bleeding
- Pain
The use of normal saline as a distending medium,
and limiting the infused volume to less than
1000 mL is recommended to decrease the risk of
the above complications.
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