General Information; Device Description; Intended Use And Contraindications; Intended Use - Arthrex Synergy Insufflation FM134 Instructions D'utilisation

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General Information

3.1

Device Description

The Synergy Insufflation FM134 serves to create a cavity by insufflating CO2 dur-
ing diagnosis and/or therapeutic laparoscopy procedures.
• The High Flow operating mode of the device is intended to be used in conjunc-
tion with a laparoscope to fill and distend a peritoneal cavity with gas.
• The Bariatric operating mode is used for laparoscopic surgery on morbidly
obese patients.
The High Flow operating mode is designed explicitly for laparoscopies performed
on normal weight and slightly overweight patients (BMI < 30 kg/m
High Flow operating mode, the insufflator limits the pressure to max. 30 mmHg
and the gas flow rate to max. 40 l/min. The device measures the pressure within
the abdomen and compares the nominal with the actual abdominal pressure.
The function of this device is to maintain the nominal pressure. Any overpressure
within the abdomen is lowered to the preset nominal pressure by the automatic
venting system.
The Bariatric operating mode is used for laparoscopies performed on severely
overweight adults (BMI > 30 kg/m
its the pressure to max. 30 mmHg and the gas flow rate to the max. value listed
on the equipment data label located on the back of the device. This operating
mode enables the rapid insufflation of large volumes.
3.2

Intended Use and Contraindications

3.2.1

Intended Use

The Synergy Insufflation FM134 is a CO
diagnostic and/or therapeutic endoscopic procedures to distend the peritoneal
cavity by filling it with gas.
3.2.2

Contraindications

The device may not be used to fill an abdomen with CO
traindicated. The device is not suitable for hysteroscopic insufflation procedures,
i.e., it may not be used to distend the uterus.
3.3

General Warnings and Precautions

3.3.1

General Warnings

WARNING!
Condensation / Water penetration
Protect device from moisture. Do not use if moisture has penetrated the device.
WARNING!
Original accessories
For your own safety and that of your patient, use only original accessories.
WARNING!
Check all factory settings.
Factory settings are not mandatory settings for the physician. The physician is re-
sponsible for all settings affecting the surgical procedure.
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). While in Bariatric mode, the insufflator lim-
insufflator intended to be used during
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if a laparoscopy is con-
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). While in
Contraindications
General Information
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