Warnings And Precautions; General - CooperSurgical Endosee Manuel De L'utilisateur

Endosee System - User Manual
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2 Warnings and Precautions

This section contains important safety information
related to use of the The Endosee
Cannula . Other important safety information is
provided 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

• CAUTION: Federal Law (USA) restricts the device to
sale by or on the order of a physician.
System is intended only as an
• The Endosee ®
adjunct in patient assessment. It must be used in
conjunction with clinical signs and symptoms.
• The Endosee System is for use only by physicians
®
with adequate training in hysteroscopy and/or
cystoscopy.
• 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.
System and the
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