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USER MANUAL 16-2045 

Rev. 09/2017

 

 

 

Page 12 of  25 

 

6.4 Activating / Switching-off insufflation 

 
Press the “RUN” button on the interface menu to start insufflation. A chronometer is displayed 
on the screen when insufflation is in progress. The MENU is not accessible when insufflation 
is in progress. To access it, insufflation must be halted by tapping on 

“STOP”.  

Insufflation begins in low-flow mode (2 l/min), so that the pneumoperitoneum is created in the 

safest of conditions. When the low flow rate is activated, the “low flow rate” is displayed in blue 
on the screen. 

The  high  flow  rate  mode  is  activated  manually  by  tapping  the  corresponding  sign  on  the 

interface  menu  or  automatically  if  automatic  change-over  is  activated  (in  the  menu 
parameters). 

Automatic change-over is used to automatically change from low-flow mode to high-flow mode 

once the pressure setpoint has been reached. When the high flow rate is activated, 

“high flow 

rate” is displayed in blue. 

 

The automatic change-over must be selected on the surgeon

’s orders. Tap on “STOP” 

to stop the insufflation.

 

 

6.5 Controls 

 
When the pneumoperitoneum has been created at the required pressure, the insufflator will 
keep this cavity at the pressure selected and will immediately compensate for any leakage of 
CO2. 

 The high-flow mode must be activated in order to benefit from maximum reactivity from 

the insufflator.  

 When  the  determined  pressure  has  been  reached,  the  insufflator  will  stop  insufflating. 

The  insufflator  will  resume  as  soon  as  the  pressure  in  the  cavity  falls  below  the  pressure 
selected.  

 Control the pressure in the trocar during gas input. 

 

6.6 Excessive pressure 

 
As soon as the instantaneous pressure in the cavity exceeds the pressure setpoint by 2 mm 
Hg: 
- The message 

EXCESSIVE PRESSURE

 is displayed on the screen. 

The insufflator then opens the external desufflation valve to lower the pressure in the cavity. 
As soon as the pressure in the cavity exceeds the pressure setpoint by 5 mm Hg: 
- The instantaneous pressure display turns orange 
The insufflator then opens the external desufflation valve to lower the pressure in the cavity. 
 
 
 
 
 
 
 

Содержание 16-2045

Страница 1: ...USER MANUAL 16 2045 FUSION INSUFFLATOR ...

Страница 2: ...______________________9 6 Operating guidelines _________________________________________10 7 Special Features ____________________________________________13 8 Suggested decontamination procedures__________________________17 9 After sales service and maintenance____________________________ 17 10 Troubleshooting ____________________________________________ 18 11 Technical characteristics____________...

Страница 3: ...g special attention Symbol provides advice To facilitate installation and use of the device we have attempted to make the device manual more practical Consequently references to the product presentation on page 35 like D1 for example will be provided for easier viewing of the relevant product parts This user manual is an integral part of the device It must be made available to the user For the pro...

Страница 4: ...r cord A user manual A Quickstart guide An external filter An open end spanner for the high pressure tubing hose connector and for connecting disconnecting the external filter Optional accessories Reusable Y tubing 16 2040 100Y Disposable viral filter 16 2040 200 High pressure and low pressure tubing hoses for connection to CO2 cylinders and CO2 wall points Ackermann Art Nr 16 2040 2000 High press...

Страница 5: ...e user alone shall be responsible for any damage that may result from improper use Comply with the conditions of use and storage The device must be opened only by a competent technician authorized by the manufacturer Do not insert metal objects into this device This is to avoid any risk of electrical shock fire short circuit or hazardous emissions Do not expose the device to splashed water or stor...

Страница 6: ...theatres To ensure proper hygiene between patients and avoid contamination make sure tubes are thoroughly sterilized Do not drop the device If the device falls do not reconnect the device but send it back to your authorised distributor Do not move the device when an operation is in progress The use of accessories transducers or cables other than those specified with the exception of transducers an...

Страница 7: ...nsufflation allows for 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 inte...

Страница 8: ...ect of interference from other devices or an unfavorable electromagnetic environment In order to avoid these situations it is advisable to Ensure of the quality of the electric power system especially the grounding of all devices and medical carts Keep the device away from electromagnetic sources e g compressors motors transformers HF generators etc 4 3 Medical device vigilance Like any medical de...

Страница 9: ...ated Connect the power cord to the mains socket of the device C3 Check that the external filter is properly in place on the CO2 input socket C6 This is necessary for the protection of the internal circuits and will help prolong the life of the insufflator 5 2 Connecting to a cylinder of medical CO Maximum allowed operating pressure 60 bars Never begin any surgical operation without having a CO2 re...

Страница 10: ...manufacturer does not accept any liability in this case This device must only be used by qualified staff The surgeon and anaesthesiologist shall at all times be responsible for the device and the anaesthesiologist shall undertake special vigilance of gas levels in the blood The safety features on this device are in no way intended to reduce the responsibility of medical staff with respect to const...

Страница 11: ...d to the patient We recommend connecting the patient end of the tubing hose to a Verres needle in the first phase This first phase corresponds to low flow insufflation max 2L min until the pressure setpoint is reached Once the pressure setpoint has been reached you can move on to the second phase consisting of high flow mode up to 45L min with the patient end tubing hose connected to the trocar Th...

Страница 12: ...ue The automatic change over must be selected on the surgeon s orders Tap on STOP to stop the insufflation 6 5 Controls When the pneumoperitoneum has been created at the required pressure the insufflator will keep this cavity at the pressure selected and will immediately compensate for any leakage of CO2 The high flow mode must be activated in order to benefit from maximum reactivity from the insu...

Страница 13: ...ing off the device Press the Standby button S1 to put the device in Standby mode Turn the power switch S2 to the O position to turn off the device 7 Special features 7 1 Control from the Ackermann Fusion camera head Ackermann Fusion camera only The following insufflator functions can be controlled using one of the three programmable buttons located on the camera head RUN in low flow mode HIGH FLOW...

Страница 14: ...sensor If the measurement circuit is not functioning properly the consistency of the measurements is constantly monitored this means that the insufflation cycles can be interrupted if there is the slightest doubt High pressure discharge valve If excessive pressure is created in the high pressure regulator a safety valve is available to limit the risks Bacterial filter This filter limits the risk o...

Страница 15: ...y risk of deterioration or contamination 7 8 Testing of medical CO cylinder pressure This latest generation of insufflators is equipped with a pressure measurement system in the cylinder with continuous visibility When the pressure in the CO2 cylinder reaches 40 bars the corresponding logo is displayed in orange When the pressure in the CO2 cylinder reaches 20 bars the corresponding value is displ...

Страница 16: ...acity on the same device This device can be connected to the CO2 system between 3 and up to 5 bars and to medical CO2 cylinders In the MENU simply select WALL POINT or CYLINDER 7 12 Pure function If a CO2 cylinder is connected the interface Purge button can be used to purge the high pressure hose before disconnecting it from the cylinder To do so remove the tubing hose from the insufflator close o...

Страница 17: ...he insufflator by removing them with a slightly moistened cloth The device must always be decontaminated before sending it back to the manufacturer or distributor 9 After sales service and maintenance No particular maintenance operation is needed for this device Note misuse is not covered by the warranty If a fault persists and the device has to be returned to the distributor ensure that it is shi...

Страница 18: ... hose Trocar valve closed during insufflation Open the trocar Chck the tubing hose Tubing hose missing Connect the tubing hose The tubing hose is not correctly connected Correctly connect the tubing hose to C1 and C2 Tubing hose fault detected Sent the device to the distributor for repair Tubing hose obstructed Bent tubing hose stretch out the tubing hose Trocar valve closed during insufflation Op...

Страница 19: ...setting 0 to 25 mm Hg accuracy 1 mm Hg External exsufflation valve Automatic low flow high flow function selection option Interface Touch screen displaying immediate flow rate pressure in the cavity total volume of CO2 used and low cylinder levels Energy supply Types of energy 100 230 V AC 50 60 Hz Fused protection 2 x 2 5 AT 250 V delayed action UR fuses Power consumption 75 VA Mechanics Dimensio...

Страница 20: ...magnetic environment specified below The user must ensure that it is in fact used in this environment Emission test Compliance electromagnetic environment guide RF emissions CisPR 11 group 1 This insufflator only uses radio energy for its sub systems it therefore emits very weak RF energy and is not likely to interfere with nearby electronic devices RF emissions CisPR 11 Class A This device must b...

Страница 21: ...nment electric shocks EN 61000 4 5 Differential mode 1 kV shared mode 2 kV 1 kV 2 kV The quality of the electric power supply must be that of a commercial or typical hospital environment Power failures short power interruptions and variations in voltage EN61000 4 11 5 UT 10 ms 40 UT 100 ms 70 UT 500 ms 5 UT 5 s 5 UT 10 ms 40 UT 100 ms 70 UT 500 ms 5 UT 5 s The quality of the electric power supply ...

Страница 22: ... corresponding to the transmitter frequency Recommended separation distance d 1 16 P d 1 16 P 80 Mhz to 800 Mhz d 2 33 P 800 Mhz to 2 5 ghz Where is the maximum output power from the transmitter in Watts W assigned by the manufacturer of the transmitter and d is the recommended separation distance in metres m The field strengths emitted by fixed RF transmitters which must be established by in situ...

Страница 23: ... RF interference produced is controlled The user of this insufflator can help avoid electromagnetic interference by maintaining a minimum distance between the portable and mobile RF communication systems transmitters and this insufflator as recommended below based on the maximum output strength of the communication system Assigned maximum output strength of the transmitter in W separation distance...

Страница 24: ... than a protective earth or a neutral conductor allowing direct connection between the electrical equipment and the equalizing bar of the installation potential Please consult standard IEC 60601 1 3rd edition T Timed Fuses UL CSA Device of CF type CF type device Electronic and electrical equipment put on the market after 13 08 2005 This symbol indicates that this product must not be processed with...

Страница 25: ...USER MANUAL 16 2045 Rev 09 2017 Page 25 of 25 ...

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