4
Safety Information
EN
2
Safety Information
Federal Law (only for U.S. market)
CAUTION: Federal Law restricts this device to sale by or on the order of a physi-
cian.
Exclusion of liability
The manufacturer is not liable for direct or consequential damages, and the war-
ranty becomes null and void if:
• the device and/or the accessories are improperly used, prepared, or main-
tained;
• the instructions and rules in the instructions for use are not adhered to;
• unauthorized persons perform repairs, adjustments, or alterations on the de-
vice or accessories;
• unauthorized persons open the device;
• the prescribed inspection and maintenance schedule is not adhered to.
The handing over of technical documents does not constitute authorization to
make repairs or alterations to the device or accessories.
Authorized trained personnel
Only a SurgiQuest technician may perform repairs, adjustments, or alterations
on the device or accessories and use the service menu. Any violation will void the
manufacturer's warranty.
Intended use
The SurgiQuest AirSeal® iFS System is intended for use in diagnostic and/or ther-
apeutic endoscopic procedures to distend a cavity by filling it with gas, to estab-
lish and maintain a path of entry for endoscopic instruments and to evacuate
surgical smoke. It is indicated to facilitate the use of various laparoscopic instru-
ments by filling the abdominal cavity with gas to distend it, by creating and
maintaining a gas sealed obstruction-free instrument path and by evacuating
surgical smoke. This instrument is used to insufflate the rectum and colon to fa-
cilitate endoscopic observation, diagnosis and treatment. The trocar of the
AirSeal® iFS System is indicated for use with or without visualization.
Care and maintenance
The service and maintenance of the device and its accessories has to be carried
out as per instructions to ensure the safe operation of the device. For the protec-
tion of the patient and the operating team, check that the device is properly con-
nected and functional.
Maintenance of the device may not be performed during the operation.
Contamination
Before shipping, decontaminate device and accessories in order to protect the
service personnel. Follow the instructions listed in this manual. If this is not pos-
sible,
• the product must be clearly marked with a contamination warning and
• is to be double-sealed in safety foil.
The manufacturer has the right to reject contaminated products for repair.
Waste management
This symbol indicates that the waste of electrical and electronic equipment must
not be disposed of as unsorted municipal waste and must be collected separately
instead. Please contact the manufacturer or an accordingly authorized disposal
or waste management company for further information.
2.1
Hazards
WARNING!
Condensation / Water penetration
Protect device from moisture. Do not use if moisture has penetrated the device.
Содержание AirSeal iFS
Страница 1: ...EN Instructions for use...
Страница 4: ......
Страница 6: ...2 EN 15 AirSeal iFS Warranty 52 16 Test Log 53 16 1 Test Log 53 16 2 Return Form 54 Index 55...
Страница 20: ...16 Initial Device Startup EN House gas supply pressure OK House gas supply pressure too low...
Страница 57: ...Test Log 53 EN 16 Test Log 16 1 Test Log Date Results Comment Signature...
Страница 60: ...W55 186 EN AA...