Device Purpose
9
EN
60601-2-18 for endoscopic devices and IEC 60601-1 / EN 60601-1 for electrical
medical devices. All configurations have to comply with IEC 60601-1 / EN 60601-
1 specifications. Whoever connects additional equipment to signal output or sig-
nal input is considered the system configurator and as such is responsible for
complying with requirements of the standard IEC 60601-1 / EN 60601-1.
WARNING!
Idiosyncratic reactions
Patients with sickle cell anemia or pulmonary insufficiency may have a higher
risk of metabolic imbalance related to excessive CO
2
absorption (idiosyncratic
reaction).
WARNING!
CO
2
absorption
CO
2
is absorbed during insufflation (intravasation). This means the body absorbs
part of the CO
2
gas used for insufflation. CO
2
concentrations in the blood or re-
spiratory system that are too high can lead to death of the patient in extreme
cases. To lower this risk, always carefully and closely monitor the patient's vital
signs during the entire insufflation process and make sure patient is breathing
well. Sufficient respiration can help avoid or limit problems with CO
2
. High pres-
sure or a high gas flow promotes CO
2
absorption. Pressure values above
15 mmHg are required for only a few cases but do increase the risk of intravasa-
tion. Never exceed the max. cavity pressure of 30 mmHg. It is recommend to not
exceed insufflation pressures >15 mmHg in colo-rectal procedures.
WARNING!
The insufflation of CO
2
should be done carefully and while monitoring the pa-
tient's response. The user, particularly the anesthetist, should be informed about
possible cardiovascular and respiratory problems of the patient and monitor
these intra-operatively.
WARNING!
Metabolic and cardiac reactions
Insufflating CO
2
may result in metabolic acidosis. This can lead to cardiac irregu-
larities expressed with the following symptoms:
• Reduced respiration with restricted diaphram function
• Hypercapnia
• Reduction of venous reflux
• Reduced cardiac output
• Metabolic acidosis
WARNING!
Hypothermia/monitoring body temperature
The gas flow can lead to a lowering of the patient's body temperature during in-
sufflation. Hypothermia during insufflation can cause heart and cardiovascular
problems. To reduce this risk, minimize high gas flows due to large leaks, the use
of cold irrigation and infusion solutions. Always monitor the patient's body tem-
perature during the entire surgical procedure.
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...