ACKERMANN 16-2045 User Manual Download Page 24

Page: 24 / 25

USER MANUAL 16-2045

Rev. 09/2017

Page 24 of 25

13 Symbols

Button

Indicator light

Socket

I Label

Manufacture date

Manufacturer

Class I product

Conforming to European directive 93/42/EEC

An equipotential earth socket conductor other 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 household
waste.

Read the user manual.

Summary of Contents for 16-2045

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

Page 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____________...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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 ...

Page 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...

Page 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...

Page 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...

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

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