Device-Inherent Dangers - Laparoscopy - Stryker PNEUMO SURE Instrucciones De Uso

Device Purpose
EN
10
nected to instruments which are intended for intra-abdominal CO
WARNING!
Electronic device control
Do not close the valve at the trocar sleeve during surgery. The electronic control
unit of the device adjusts the actual pressure as desired.
WARNING!
Medically pure CO
2
Make sure to use only medically pure CO
mixtures of gases, high pressure compressed gases, gases with entrapped liq-
uids, or polluted gases must not be used with this device.
WARNING!
Service connection
Connected devices have to comply with the EN 60950 standard. Do not connect
a device to the service connection during surgery.
CAUTION!
Electrical Interference
(See chapter 14 Electromagnetic compatibility). Electrical interference with oth-
er devices or instruments was practically eliminated when developing this devic-
es and none was detected during testing. However, if you still detect or suspect
such interference, please follow these suggestions:
• Move this, the other or both devices to a different location
• Increase distance between used devices
• Consult an electro-medical expert
WARNING!
Peripheral devices
Additional peripheral equipment connected to interfaces of the medical monitor
has to meet the requirements of the following specifications: IEC 60601-2-18 /
EN 60601-2-18 for endoscopic devices and IEC 60601-1 / EN 60601-1 for electri-
cal medical devices. All configurations have to comply with IEC 60601-1 / EN
60601-1 specifications. Whoever connects additional equipment to signal out-
put or signal input is considered the system configurator and as such is responsi-
ble for complying with requirements of the standard IEC 60601-1 / EN 60601-1.
3.3.1

Device-Inherent Dangers - Laparoscopy

WARNING!
Because pediatric patients are especially susceptible to hypercapnia, it is recom-
mended to establish an end-tidal CO2 monitoring routine.
WARNING!
Gas flow limit
The gas flow may not exceed 14 l/min when performing a laparoscopy on new-
borns or patients weighing less than 25 kg (approx. 55 US pounds).
insufflation.
2
. Other gases (i.e., helium, N
2 2
O, argon),