Introduction; Safety Instructions; Use; Contraindication - SOPRO COMEG 640-45L Manual De Usuario

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Sections marked with the symbol
Sections marked with the symbol
Please read this manual carefully before using the device, pay particular attention to the sections dealing with safety conditions and environmental
conditions related to the device.
A. USE
This device is designed to create pneumoperitoneum (distension of the abdomen with CO
Please refer to your laparoscope user manual for information on specific use.
The aim of this user manual is not to tell the user how to perform a laparoscopy but simply to explain how to use this insufflator.
FEDERAL LAW:
Federal Law in the United States restricts the use of this device solely to, or under the supervision of, a surgeon.
B. CONTRAINDICATION
Use of this device in cases of intra-abdominal distension is contraindicated at all times when laparoscopy is contraindicated. Please refer to your laparoscope
user manual for absolute and relative contraindications.
This device is contraindicated for hysteroscopic insufflation; on no account it must be used in cases of intrauterine distension.
Note: the distension pressure of an insufflator for laparoscopy must not exceed 25 mmHg
C. WARNING
• Metabolic acidosis and resulting cardiac irregularity
Avoid prolonged intra-abdominal pressures above 20 mm of mercury. This would cause one of the following risks:
• Reduction of respiration with compromised diaphragmatic movement
• Reduction of venous return
• Reduction of cardiac output
• Acidosis
Excessive absorption of CO is due to either a too high flow rate or excessive pressure, or both. The abdomen can be sufficiently distended by a pressure between
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10 and 15 mm of mercury. It is rarely necessary to select an abdominal pressure higher than 15 mm of mercury. At these levels, the extent of intravascular
penetration should be low. Pressures higher than 20 mm of mercury are hardly ever necessary; they will increase the quantity and the speed of intravascular
penetration. Adequate respiration helps to prevent problems associated with CO
• Idiosyncratic reactions
For patients suffering from microdrepanocytic diseases or pulmonary insufficiency, the use of these devices can present an increased risk of metabolic imbalance
related to the excessive absorption of CO
• Hypothermia
High-flow insufflators involve a potential risk of hypothermia; therefore we recommend using a heating system to keep the patient's temperature stable.
• Gas flow
Surgical procedures must be carried out with insufflators able to reach flows between 4 to 10 l/min. Insufflators providing lower flow must only be used for
diagnostics procedures.
• Gas coagulation system
Some medical devices delivering gas to the interior of the peritoneal cavity during surgical laparoscopies (gas lasers, for example) may lead to abdominal over-
pressurization. If venous sinuses are formed, triggering an embolism, the use of a secondary gas source that is far less soluble in the blood than CO
rapid rise in intra-abdominal pressure. We recommend avoiding the use of these coagulation systems during laparoscopic procedures, as the manufacturer could
not be held responsible for any incident associated with their use.
E N G L I S H

INTRODUCTION

deal with points that require particular attention.
are just for information.

SAFETY INSTRUCTIONS

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gas) as part of a diagnostic and/or operative laparoscopy procedure.
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