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USER MANUAL 16-2045 

Rev. 09/2017

 

 

 

Page 22 of  25 

12-3 

Manufacturer’s guide and declaration – electromagnetic safety 

This insufflator was designed to be used in the electromagnetic environment specified below. The 
user must ensure that it is in fact used in this environment. 

Safety test 

IEC 
60601 
level of 
gravity 

Compliance 
level 

electromagnetic environment - guide 

RF 
conducted 
EN 61000-4-

RF emitted 
EN 61000-
4-3 

3 Vrms 
150 khz at 80 
Mhz 

3 V/m 
80 Mhz at 
2.5 ghz 

3V 3V/m 

Portable  and  mobile  RF  communication  devices 

– 

cables included - must not be used at a distance nearer 
than what is recommended. This distance is calculated 
by applying the formula 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  electromagnetic 
measurements 

–  must  be  lower  than  the  compliance 

strength in each frequency band. 

interference  may  be  caused  by  devices  on  which  the 
following symbol is displayed 

:  

Note 1: at 80 Mhz and 800 Mhz, it is advisable to use the highest frequency band. 
Note  2:  these  recommendation  may  not  be  applicable  in  all  situations.  The  propagation  of  
electromagnetic waves is modified by absorption and reflection due to structures, objects and people. 

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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