USER MANUAL
16-2040N / 16-2041N / 16-2042N
INSUFFLATOR 20L / 30L / 45L
Page 1: ...USER MANUAL 16 2040N 16 2041N 16 2042N INSUFFLATOR 20L 30L 45L ...
Page 2: ...manufacturer The manufacturer will appreciate any errors or anything unclear in this operating manual being pointed out to us by users of our products Due to the continuing progress and development of our products we reserve all rights for technical alterations Rev 07 2016 SERVICE ADDRESS Ackermann Instrumente GmbH Eisenbahnstrasse 65 67 78604 Rietheim Weilheim Germany Tel 49 0 7461 96617 0 Fax 49...
Page 3: ... 9 5 2 SCOPE OF SUPPLY 9 5 3 RECOMMENDED ACCESSORIES OPTIONAL 9 5 4 ELECTRICAL CONNECTION 9 5 5 EQUIPOTENTIAL BONDING 9 5 6 CONNECTING THE GAS CYLINDER 10 5 7 DISCONNECTING THE GAS CYLINDER 10 6 CREATING AND MAINTAINING PNEUMOPERITONEUM 10 6 1 STARTING THE INSUFFLATOR 10 6 2 CONNECTING DISCONNECTING THE PATIENT TUBING 11 6 3 MODIFYING PARAMETERS VIA THE MENU 12 6 4 PRESSURE INITIAL SETTING 12 6 5 ...
Page 4: ...NING Metabolic acidosis and resulting cardiac irregularity Avoid prolonged intra abdominal pressures above 20 mm of mercury This would cause one of the following risks Reduction of respiration with compromised diaphragmatic movement Reduction of venous return Reduction of cardiac output Acidosis Excessive absorption of CO2 is due to either a too high flow rate or excessive pressure or both The abd...
Page 5: ... and do not install it in a very humid area Use only the ancillary equipment delivered with the device or suggested by the manufacturer as an option Do not connect this device to any other device This insufflator must not be used in the presence of flammable anesthetics This device has not been designed for use in an ionizing environment 2 SATUTORY RECOMMENDATIONS 2 1 COMPLIANCE This device was de...
Page 6: ... on the device and or in the accompanying documentation indicates that this product may on no account be treated as household waste It must therefore be delivered to a waste collection point for the recycling of electrical and electronic equipment For disposing of the device please observe the standards applied in the country of installation To obtain complete details about the treatment recovery ...
Page 7: ...of the measurements is continuously monitored this means that the insufflation cycles can be interrupted if there is the slightest cause of doubt A high pressure relief valve If over pressurization occurs at the level of the high pressure regulator a safety valve is available to limit any risk 4 2 LOW FLOW In this mode the insufflation flow is limited to 2 l min to create a pneumoperitoneum This f...
Page 8: ... the user via The display of the cylinder pressure in the alarm area A red light on the display Below 10 bars the insufflator is not allowed to be used 4 7 LCD DISPLAY In order to communicate better with the user and to improve the ease of use we have equipped our latest generation of insufflators with a 5 7 inch LCD display This allows the following to be displayed in 5 different languages warnin...
Page 9: ... pressure hose connector 1x Set of 1 sterile disposable Y tubes equipped with a viral filter packed in a separate box 1x 5 3 RECOMMENDED ACCESSORIES OPTIONAL Pin connector type DIN 477 1 no 6 or US 7 16 High pressure CO2 feed hose Pmax 200 bar 1m long 5 4 ELECTRICAL CONNECTION Check that the specifications of the main power supply include 100 to 230VAC and 50 Hz 60 Hz with a required power of 40VA...
Page 10: ...de the system by gently loosening it 6 CREATING AND MAINTAINING PNEUMOPERITONEUM This insufflator is intended only for diagnostic or operative laparoscopy Any use outside this area constitutes misuse of the product for which the user will be responsible and for which the manufacturer declines all responsibility This device must be used only by qualified staff The surgeon and the anesthetist will b...
Page 11: ...ing is damaged Sterile tubes are disposable do not re sterilize Use of a hydrophobic bacterial filter is essential for the prevention of cross contamination with the patient Open the first set of packaging film around the tubing Hand the second set to sterile personnel Keep the patient s sterile tube in the operating theatre Open the second sterile pouch and connect the tubing to the insufflator s...
Page 12: ...lected by order of the surgeon 6 4 PRESSURE INITIAL SETTING This operation must be carried out by or under the control of an experienced surgeon Use the thumbwheel to help you select the required intra abdominal pressure between 0 and 24 mmHg The pressure that is commonly used is 12 mmHg which is sufficient for most operations You will be asked as a safety precaution to confirm if blow off pressur...
Page 13: ...nto the trocar and the instrumentation than by the performance of the insufflator Once blow off pressure is reached the insufflator stops insufflating Insufflation restarts as soon as intracavitary pressure drops below blow off pressure 6 7 OVER PRESSURIZATION As soon as intracavitary pressure exceeds blow off pressure by 5mmHg The message OVER PRESSURIZATION is then displayed on the screen There ...
Page 14: ...LCD screen in liters minute 6 9 MONITORING THE VOLUME OF GAS USED The volume of gas used is shown in litres on the LCD display to the nearest deciliter This meter is started by pressing on the button F and only resets to zero once the device is no longer in use If necessary set it to zero via the menu PAGE 14 OF 21 ...
Page 15: ...ed the cylinder must be changed immediately No operation may proceed using a cylinder below a level which would not last the duration of the surgery 6 11 END OF OPERATION Stop insufflation by pressing F the STOP icon appears Disconnect the tubing from the trocar and the insufflator immediately to prevent any liquid or gas from flowing back to the device The used tubing must be disposed of in an ap...
Page 16: ...un Remove the tubing for 2 seconds then replace Fault in tubing detection Send device for servicing CO2 NOT DETECTED Gas cylinder valve closed Open the valve Insufflator high pressure hose disconnected Connect the hose correctly to the insufflator SERVICE Maintenance action essential Send device for servicing No power Fuses damaged Check and replace the 2 5A UR fuses if necessary For any other pro...
Page 17: ...re all relevant information to establish liability before we can proceed Immediately check functionality of the delivered equipment All repairs on the equipment will be performed by us and we reserve the right to withhold any technical data 9 SYMBOLS USED DESCRIPTON CORRESPONDING Class 1 device Class 1 Type BF device UR time lag fuse conforms to UL standard Record of equipotential Connector for CO...
Page 18: ...nment Operating temperature range 10 C 40 C Operating relative humidity range 30 to 75 Transport and storage temperature range 10 C 40 C Transport and storage relative humidity range 20 to 85 Operating transport and storage atmospheric pressure range 700hPa to 1060hPa Standards Electrical protection class 1 type BF Conforms to European directive 93 42 CEE on medical devices class IIa Conforms to s...
Page 19: ... ELECTROMAGNETIC ENVIRONMENT GUIDE Electrostatic discharges EN 61000 4 2 6 kV via contact 8 kV via air 6 kV 8 kV The floor should be in timber concrete or tiling If the floor is covered with a synthetic material the relative humidity should be at least 30 Quick transients in bursts EN 61000 4 4 2 kV for power lines 1 kV for input output lines 2 kV 1 kV The quality of the main power supply should b...
Page 20: ...romagnetic measurement at the site must be lower than the compliance level in each frequency band Interference can occur nearby devices bearing the following symbol Note 1 At 80 MHz and 800 MHz the higher frequency band applies Note 2 These recommendations may not apply in all situations The propagation of electromagnetic waves is modified by absorption and reflection due to structures objects and...
Page 21: ...16 P d 2 33 P 0 01 0 1 1 10 100 0 116 0 366 1 16 3 66 11 6 0 116 0 366 1 16 3 66 11 6 0 233 0 736 2 33 7 36 23 3 Note 1 At 80 MHz and 800 MHz the higher frequency band applies Note 2 These recommendations may not apply in all situations The propagation of electromagnetic waves is modified by absorption and reflection due to structures objects and people For transmitters of which the maximum output...
