Karl Storz UI400 Endoflator 40, Instruction Manual

Page 1: ...GEBRAUCHSANWEISUNG UI400 ENDOFLATOR 40 INSTRUCTION MANUAL UI400 ENDOFLATOR 40 ŸŽƁƂƀƃźƆŸƏ ſž ƍźƁſŻƃŰƂŰƆŸŸ UI400 ENDOFLATOR 40 ...

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Page 3: ...RZ brand name Like all of our products this product is also the result of years of experience and careful manufacturing You and your organization have decided in favor of a modern high quality product from KARL STORZ This instruction manual is intended to serve as an aid in the proper setup installation and operation of the ENDOFLATOR 40 All of the necessary details and actions are clearly explain...

Page 4: ...IV 2 Geräteabbildungen 1 4 6 7 8 9 2 3 5 0 q Images of the equipment Geräteabbildungen 2 Images of the equipment ƁƞƟƠƞƒƞƔƘƢƕƛƬƝƫƕ ƘƛƛƮơƢƠƐƦƘƘ 2 ƁƞƟƠƞƒƞƔƘƢƕƛƬƝƫƕ ƘƛƛƮơƢƠƐƦƘƘ ...

Page 5: ...lation connection to patient 4 Gas connection American connection 5 SCB connectors 6 Service interface concealed 7 Ethernet interface concealed 8 Potential equalization connector 9 Power cord socket 0 Line fuse holder q Holder for CO2 bottle optional cat no UI005 ƍƛƕƜƕƝƢƫ ƣƟƠƐƒƛƕƝƘƯ ƘƝƔƘƚƐƢƞƠƫ ƠƐƗƪƕƜƫ Ƙ Ƙƥ ƤƣƝƚƦƘƘ 3 ƍƛƕƜƕƝƢƫ ƣƟƠƐƒƛƕƝƘƯ ƘƝƔƘƚƐƢƞƠƫ ƠƐƗƪƕƜƫ Ƙ Ƙƥ ƤƣƝƚƦƘƘ 1 ƁƕƢƕƒƞƙ ƒƫƚƛƮƧƐƢƕƛƬ O ƒƫƚƛ 2...

Page 6: ...ƘƐƛƞƒ ƍƛƕƜƕƝƢ ƟƠƘƜƕƝƕƝƘƯ ƢƘƟƐ CF ſƕƠƕƜƕƝƝƫƙ Ƣƞƚ ſƠƕƔƞƢƒƠƐƩƕƝƘƕ ƗƐƓƠƯƗƝƕƝƘƯ ƞƚƠƣƖƐƮƩƕƙ ơƠƕƔƫ ƭƛƕƚƢƠƞƝ ƝƫƜƘ ƟƠƘƑƞƠƐƜƘ ŴƘƠƕƚƢƘƒƐ RoHS źƘƢƐƙ ŴƐƝƝƫƙ ƟƠƘƑƞƠ ƜƐƠƚƘƠƞƒƐƝ ƒ ơƞƞƢƒƕƢơƢƒƘƘ ơ ŵƒƠƞƟƕƙơƚƞƙ ŴƘƠƕƚƢƘƒƞƙ ƞƑ ƞƢƥƞƔƐƥ ƭƛƕƚ ƢƠƘƧƕơƚƞƓƞ Ƙ ƭƛƕƚƢƠƞƝƝƞƓƞ ƞƑƞ ƠƣƔƞƒƐƝƘƯ Waste Electrical and Electronic Equipment WEEE ſƠƞƘƗƒƞƔƘƢƕƛƬ ſƞƯơƝƕƝƘƕ ơƘƜƒƞƛƞƒ 4 ſƞƯơƝƕƝƘƕ ơƘƜƒƞƛƞƒ 4 1 ƁƘƜƒƞƛƫ ƝƐ ƟƠƘƑƞƠƕ Symbole auf Label ...

Page 7: ...use connection input pressure too high or too low Gas bottle input pressure above 40 bar Gas bottle input pressure between 40 and 30 bar Gas bottle input pressure between 30 and 10 bar Gas bottle input pressure below 10 bar Gas bottle input pressure too high Display of gas consumption Reset the display by clicking on the 0 button ſƞƯơƝƕƝƘƕ ơƘƜƒƞƛƞƒ 4 2 ƁƘƜƒƞƛƫ ƒ ƟƞƛƬƗƞƒƐƢƕƛƬơƚƞƜ ƘƝƢƕƠƤƕƙơƕ ŽƐơƢƠƞƙ...

Page 8: ...ot be resterilized CE mark Do not use the product if the packaging has been damaged Consult instructions for use Rx ONLY In the USA federal law restricts this device to sale or use by or on the order of a physician Store in a dry place Store out of direct sunlight Sterilized with ethylene oxide Use by date of the product Production batch label ſƞƯơƝƕƝƘƕ ơƘƜƒƞƛƞƒ 4 3 ƁƘƜƒƞƛƫ ƝƐ ƭƢƘƚƕƢƚƕ ƓƐƗƞƒƞƓƞ ƤƘ...

Page 9: ... of physician and assistants 13 6 5 Intended conditions of use 13 6 5 1 Use 13 6 5 2 Other intended conditions 13 6 5 3 User position 14 6 6 Safety precautions at the installation site 15 6 7 Safety precautions when operating the device 15 6 8 Safety features 16 6 8 1 Self test 16 6 8 2 Monitoring during operation 16 7 Installation and operating instructions 18 7 1 Unpacking the equipment 18 7 2 B...

Page 10: ...n 32 7 5 5 Device information 33 8 Maintenance 34 8 1 Fuse replacement 34 8 2 Reprocessing 35 8 2 1 Reprocessing of the ENDOFLATOR 40 36 8 2 2 Reprocessing of insufflation tube set with gas filter for single use sterile 36 8 2 3 Reprocessing of reusable insufflation tube 37 8 2 3 1 Preparation for cleaning and disinfection 37 8 2 3 2 Manual precleaning 37 8 2 3 3 Manual cleaning 38 8 2 3 4 Manual ...

Page 11: ... 9 Warranty 45 9 Technical description 46 9 1 Signals 46 9 1 1 Visual signals 46 9 1 2 Acoustic signals 47 9 2 Troubleshooting 49 9 3 Technical data 51 9 3 1 Standard compliance for UI400 52 9 3 2 Directive compliance for UI400 52 9 4 Technical documentation 53 10 Spare parts recommended accessories 54 10 1 Spare parts accessories 54 10 2 Accessories 55 11 Electromagnetic Compatibility EMC informa...

Page 12: ...a SENSITIVE mode which is characterized by low insufflation pressure as well as special safety limits in the pressure up to max 15 mmHg and flow ranges up to max 15 l min To quickly compensate for the considerable loss of gas occurring in complex laparoscopic operations the ENDOFLATOR 40 has been designed for a high flow rate of up to 40 l min The ENDOFLATOR 40 is operated directly via a color scr...

Page 13: ...ed by a pictogram 3 WARNING A Warning indicates that the personal safety of the patient or physician may be endangered Failure to observe a Warning could result in injury to the patient or physician 2 CAUTION A Caution indicates that particular service procedures or precautions must be followed to avoid possible damage to the device 1 NOTE A Note provides special information regarding the operatio...

Page 14: ...ination permit this cf IEC 60601 1 1 or para 16 of the 3rd edition of the IEC 60601 1 3 WARNING Grounding reliability can only be achieved when the device is connected to a Hospital only or Hospital Grade outlet Check the plugs and cables regularly and do not use if damaged 3 WARNING To avoid the risk of an electric shock this device may only be connected to a power supply network with a protectiv...

Page 15: ...s ensured 3 WARNING After 24 h of continuous operation a self test must be performed Take note of the warnings to ensure that the device is fully functional 3 WARNING The device must not be used if either the touch screen or display is defective 3 WARNING If the touch screen does not react when pressed you must turn the device off 3 WARNING Do not press several points on the touch screen simultane...

Page 16: ...should fail 3 WARNING For safety reasons do not simultaneously touch the device output sockets and the patient 3 WARNING Risk of infection Incorrectly reprocessed medical devices expose patients users and third parties to a risk of infection as well as the risk that the medical device may malfunction Observe the Cleaning Disinfection Care and Sterilization of KARL STORZ Instruments instructions an...

Page 17: ...and the tube set must not be used 3 WARNING Follow the country speciǫc regulations laws for the disposal of accessories 3 WARNING Avoid allowing Ǭuids to enter the housing Do not store liquids on or directly above the device If despite the precautions liquid enters the device sufǫcient time should be planned for evaporation this also applies for the formation of condensation 3 WARNING The device m...

Page 18: ...pper and lower gastrointestinal tract e g TEO colonoscopy In addition the ENDOFLATOR 40 is also designed to expulse ambient air in open and endoscopically assisted cardiac surgery and endoscopic vessel harvesting 3 WARNING Only sterile CO2 gas may be used Use of the device in fields other than those indicated above is not allowed for safety reasons The ENDOFLATOR 40 may only be operated with tubin...

Page 19: ...ontact your representative on site or the technical customer service 6 2 2 Contraindications No contraindications relating directly to the products used for CO2 insufflation are currently known The use of an insufflator is contraindicated if in the opinion of a qualified physician such an application would pose risks to the patient e g due to the patient s general condition The device is contraind...

Page 20: ...nitor the body temperature throughout the intervention Idiosyncratic reactions The risk of a metabolic imbalance due to increased CO2 absorption is increased for patients with sickle cell anemia or pulmonary insufficiency Dehydration For longer operations with high gas levels insufflation can lead to a drying out of the tissues or cause tissue damage Unnecessary leaks must be avoided for this reas...

Page 21: ...oroughly at least once in the use of the device No physical impairments which limit or prevent perception of acoustic or visual alarm signals 6 5 Intended conditions of use 6 5 1 Use The device is intended for use in hospitals and doctors offices The technical data and ambient conditions are described in the instruction manual 6 5 2 Other intended conditions Frequency of use one or more times a da...

Page 22: ...e the device the user should always be standing in front of the device within a cone of vision with an opening angle of 45 at a distance of approx 30 70 cm to the front panel For observation of the actual values during the application a visual distance from the device of 2 m is assumed Sicherheitshinweise Safety instructions ƃƟƠƐƒƛƕƝƘƕ ƒƞƗƜƞƖƝƞ ƣƟƠƐƒƛƕƝƘƕ ƧƕƠƕƗ KARL STORZ SCB ſƠƘƑƞƠ ƝƐƥƞƔƘƢơƯ ƒƝƕ ...

Page 23: ...ible and explosive chemicals e g skin disinfectants and fast acting surface disinfectants The device is equipped with a connector for attaching a ground line It should be connected up in accordance with the applicable national regulations 6 7 Safety precautions when operating the device It is the user s responsibility to make sure the equipment is safe and operates properly before use This device ...

Page 24: ...pressure If during insufflation the intracorporeal pressure rises above the set setpoint value by a limit dependent on the setpoint value for more than 3 seconds an acoustic information signal sounds see chapter 9 1 2 and the gas supply is stopped After a time period which can be set 5 99 seconds the overpressure is actively reduced via a blow off valve Mode specific pressure monitoring Monitoring...

Page 25: ...low measurement are equipped with safety pressure release valves The function of the mechanical high pressure regulator is monitored 1 NOTE If the monitoring system recognizes an error which renders safe functioning seemingly impossible the device is transferred into a safe state From this state the device can only be reset by turning off the power supply ƃƚƐƗƐƝƘƯ Ɵƞ ƢƕƥƝƘƚƕ ƑƕƗƞƟƐơƝƞơƢƘ ſƐơơƘƒƝƫƕ...

Page 26: ...S1 1 ENDOFLATOR 40 UI400 1 Power cord 400A 5 Insufflation tube sets with gas filter for single use sterile 1 Universal wrench 20400030 1 SCB connecting cable 20090170 length 100 cm 1 Instruction manual 1 CO2 supply tube customized Installation and operating instructions 7 3 Installing and connecting the device 1 NOTE The ENDOFLATOR 40 including the accessories connected may only be used in medical...

Page 27: ... qualified personnel 7 3 2 Connecting the power cord 3 WARNING The device may only be operated at the voltage stated on the rating plate 4 Push the power cord into the power socket as far as it will go 3 WARNING Only connect disconnect the power plug to from the power supply outside of areas subject to explosion hazards 3 WARNING The instrument may only be operated with the power cord delivered by...

Page 28: ... pulled out accidentally the SCB connector possesses a protection device Pull back the protection device of the SCB connector and insert the connector into one of the SCB sockets Connect the other end of the cord to the KARL STORZ SCB KARL STORZ Communication Bus control unit or other SCB devices see KARL STORZ SCB control NEO System Instruction Manual ƃƚƐƗƐƝƘƯ Ɵƞ ƣơƢƐƝƞƒƚƕ Ƙ ƭƚơƟƛƣƐƢƐƦƘƘ 7 3 3 KA...

Page 29: ...ear of the device Use the enclosed screws of length 6 mm Insert the CO2 bottle vertically into the holder and close the locking clip 3 WARNING Only sterile CO2 gas may be used Installation and operating instructions 7 3 5 Connecting the CO2 bottle Connect the gas outlet of the CO2 bottle to the device s gas connection using the high pressure tube supplied 3 WARNING CO2 bottles connected up to the ...

Page 30: ...other end directly to the wall outlet of the central gas supply 3 3 7 bar 7 4 Commissioning 1 NOTE The gas supply must be connected when the device is switched on otherwise an error message is emitted 7 4 1 Commissioning for the first time The ENDOFLATOR 40 is delivered as follows Screen Language English High Flow mode pressure in mmHg 1 NOTE Changing adjustment of the settings for language audio ...

Page 31: ...d an acoustic availability signal sounds and a touch screen appears Installation and operating instructions 2 Confirm the message If no gas is connected or if the input pressure is too low the warning Input pressure too low appears Now check whether the bottle is open If the gas supply was secured with a delay the switch on test is delayed and the user is notified via message 110 that the tests ar...

Page 32: ...ng Installation and operating instructions The Working screen is displayed after the switch on message 1 NOTE In routine operation insufǬation can be started and the device settings changed from here 3 Press the button 1 wrench to change to the settings mode Changing the language and other presettings 1 NOTE The screen language is preset as English The Settings screen appears 4 Press the Device Se...

Page 33: ...ect the changes with 2 7 Select the desired gas supply source under Source of gas supply Confirm the selection with 1 or reject the changes with 2 7 4 2 Normal commissioning After successfully starting see section Commissioning for the first time the Working screen appears 1 NOTE In routine operation insufǬation can be started and the device settings changed from the Working screen 1 1 1 1 1 1 2 2...

Page 34: ...sufǬation tube to prevent the risk of contamination of the device due to the reverse Ǭow of gas or body Ǭuid The CO2 ǫlter must be replaced after each use 2 Attach the insufflation tube to the CO2 gas filter and connect the other end of the insufflation tube to the VERESS needle 1 NOTE In the case of the disposable insufǬation tube set the ǫlter is ǫrmly connected to the tube ƃƚƐƗƐƝƘƯ Ɵƞ ƣơƢƐƝƞƒƚƕ...

Page 35: ...ve the setpoint value and which after a few seconds is released via the overpressure valve blow off valve This is repeated cyclically 6 Observe the instrument s conduct over a 30 second period 1 NOTE The Ǭow display may only show values greater than zero for short periods If the set pressure is only reached slowly even when the instrument s stopcock is closed or if you note stationary Ǭow rates of...

Page 36: ...ymbol Sensitive baby symbol 1 NOTE To compensate for the considerable loss of gas occurring in complex operations the High Flow mode has been ǫtted with a Ǭow rate of up to 40 l min For particularly sensitive applications the device features a SENSITIVE mode which is characterized by low insufǬation pressure as well as special safety limits in the pressure up to max 15 mmHg and Ǭow ranges up to ma...

Page 37: ...volume display using the 0 button 4 Insert the VERESS needle and open the locking lever Press the START STOP button to initiate the insufflation process 1 NOTE In order to use the maximum device Ǭow in the High Flow mode HICAP instruments with a suitable connection must be used The LUER lock connection ǫtted to the end of the insufǬation tube must be removed in this case 1 NOTE In the case of the ...

Page 38: ...ation and operating instructions Displays The insufflation pressure flow and volume of the gas used are continuously displayed in the Working screen If the patient pressure rises above the preselected value an acoustic information signal will be sounded After the set delay see Settings Administration screen the pressure is released via the overpressure valve 7 4 6 ŲƫƚƛƮƧƕƝƘƕ ſƞơƛƕ ƗƐƒƕƠƨƕƝƘƯ ƞƟƕƠƐ...

Page 39: ...personnel The settings are described in the Service Manual 7 5 3 System Log The System Log contains the saved information and alarms Each entry occupies one row and consists of a sequential number date time and alarm information ID The most recent entry is allocated the number 000 Aufstellen und Bedienhinweise Installation and operating instructions 7 5 Settings ŽƐơƢƠƞƙƚƘ Device Settings ŽƐơƢƠƞƙƚƘ...

Page 40: ...SB stick into the USB interface 3 Select Export system log on the Administration screen Exporting of the system log starts 1 NOTE The current status is shown via a progress bar This progress bar shows that the export is underway however it does not show how far it has advanced Unit pressure Select the desired unit mmHg or hPa under Unit pressure Confirm the selection with 1 or reject the changes w...

Page 41: ...erpressure for longer than the set time this is reduced If the overpressure cannot be reduced the device emits a warning 7 5 5 Device information The following elements are displayed Device serial number Operating hours Software versions Software license information Aufstellen und Bedienhinweise Installation and operating instructions 1 1 2 2 1 1 2 2 Date and Time ŴƐƢƐ Ƙ ƒƠƕƜƯ ŽƐơƢƠƞƙƚƐ ƔƐƢƫ Ƙ ƒƠƕ...

Page 42: ...line fuse holder 0 using a screwdriver or another suitable tool 3 WARNING Only use fuses of the correct rating 3 Insert new fuses 100 240 V Line fuse 2 x T2 0AH250V 4 Now put the line fuse holder 0 on again 5 Restore the power supply 6 Switch the device on and ensure that the start screen appears Instandhaltung Maintenance 8 ƂƕƥƝƘƧƕơƚƘƙ ƣƥƞƔ 8 1 ŷƐƜƕƝƐ ƟƠƕƔƞƥƠƐƝƘƢƕƛƕƙ 1 ŲƫƚƛƮƧƘƢƕ ƟƠƘƑƞƠ Ƙ ƞƢơƞƕƔƘƝ...

Page 43: ...cess the reusable insufǬation tube before initial use and before and after every subsequent use using validated procedures 3 WARNING When carrying out any work on contaminated medical devices the guidelines of the Employer s Liability Insurance Association and equivalent organizations striving to ensure personal safety must be observed 3 WARNING Risk of infection product damage KARL STORZ has vali...

Page 44: ... enter the housing under any circumstances Manual wipe down disinfection The design of the device and supply tube allows only for wipe down disinfection The exterior surfaces of the medical device must be wiped clean with a disposable cloth moistened with disinfectant or a ready to use soaked disinfectant cloth Due to their protein fixating effect and material incompatibility alcohol based agents ...

Page 45: ...ation in order to prevent contaminations from drying on or reduce this as far as possible 8 2 3 2 Manual precleaning Immersion in cold water for 5 minutes To dissolve dried organic residues immerse the reusable insufflation tube in cold water 10 20 C for 5 minutes Brushing the surfaces Any visible contamination or heavy soiling must be completely removed from all external surfaces by cleaning unde...

Page 46: ...n the instrument mechanically using a brush or sponge Finally it must be rinsed with cold water to ensure neutralization 8 2 3 4 Manual disinfection The reusable insufflation tube must be completely immersed in a disinfectant solution Through disassembling the instrument and filling the lumina in a targeted manner it must be ensured that even surfaces with restricted access are covered and no air ...

Page 47: ...f the device Connecting In order to guarantee effective machine cleaning and disinfection connect the LUER Lock to the washer and disinfector using the LUER connector provided Place the reusable insufflation tube on the rinsing lance in order to ensure that it is rinsed out completely In addition put the plastic connector with the tube adapter side to the top on the rinsing lance 1 NOTE If necessa...

Page 48: ...ssembled Afterwards a functional check must be carried out The integrity of the reusable insufflation tube can be tested in the following way Attach a syringe to one end of the tube and kink the other end Place the insufflation tube in completely demineralized water or microbiologically pure sterile water Force air into the insufflation tube using the syringe If any bubbles appear in the water whi...

Page 49: ...taking into account the specific national requirements and in consultation with the device manufacturers The following sterilization method has been validated and approved by KARL STORZ for this medical device Steam sterilization in the fractionated prevacuum procedure The medical device must be sterilized in its fully assembled state using the fractionated prevacuum procedure DIN EN ISO 17665 1 a...

Page 50: ...EC 62353 must be performed and recorded by a qualiǫed electrician at least once a year Visual inspection 1 Check the device and accessories for any mechanical damage which may impair functionality 2 Check that inscriptions relevant to safety are legible Electric measurements Inspect the device safety fuses Measure protective ground resistance in accordance with IEC 62353 The limit values can be fo...

Page 51: ...e Manual 8 4 Servicing and repair 3 WARNING Defective items of equipment must be serviced and repaired exclusively by KARL STORZ or persons authorized by KARL STORZ all repair work must employ original KARL STORZ parts only 8 5 Disposal This device has been marked in accordance with the European Directive on Waste Electrical and Electronic Equipment WEEE 3 WARNING At the end of its service life di...

Page 52: ...ent infection it is strictly forbidden to ship contaminated medical devices All medical devices must be decontaminated on site to avoid contact and aerogenous infections among staff We reserve the right to return contaminated instruments equipment to the sender Repairs modifications or expansions which are not carried out by KARL STORZ or by experts authorized by KARL STORZ will invalidate all war...

Page 53: ...ed conforms to the applicable statutes and standards and the device has been used in accordance with its operating instructions at all times 8 9 Warranty The guarantees provided can be found in the Standard Conditions of Business of KARL STORZ The medical device must always be sent to your local subsidiary see Subsidiaries section even during the warranty period Opening the equipment or performanc...

Page 54: ...mation signal is suppressed for as long as there is a signal with a higher priority If there are several signal conditions of the same priority only the condition which was recognized last will be signalized i e the previous signal is overwritten 9 1 1 Visual signals Signals are displayed inversely blue font on a white background compared to normal displays and do not flash The visual signal is is...

Page 55: ... Device settings menu The acoustic signal can however only be switched off temporarily by the user When the line voltage is switched on the setting is always Audio On Information signal general The pitch is modulated by 2 Hz with a modulation frequency of 1 5 Hz Five different harmonics are generated In the case of messages which are related to the Safe State the signal sequence is repeated every ...

Page 56: ...ibed in the Visual signals section when the pressure levels 40bar 30bar 20bar are fallen short of a double gong is produced as an acoustic signal This is a sampled sequence It lasts for 1 5 seconds If a minimum supply pressure is fallen short of the information signal is output as specified both with a high pressure supply and low pressure supply Key click Clicking on a key on the touch screen is ...

Page 57: ... causes Device defective Measure Switch unit off and back on If the warning message still appears after restarting contact Service Prior to this open the System Log under Settings and note the ID Word1 Word2 and information text of the last 5 entries Description of error No gas flow Measure Observe the warnings device temperature exceeded temperature of high pressure regulator too low gas supply n...

Page 58: ...ation there are situations in which the insufflation pressure provided is not sufficient to build up the desired cavity pressure due to a high level of instrument resistance and simultaneous gas outflow Depending on the instrument and leak conditions the current values for pressure and flow are below the setpoint values 3 a Check the connections of the accessories and the leakproofness of the troc...

Page 59: ...lation pressure ŸƝơƣƤƤƛƯƦƘƞƝƝƞƕ ƔƐƒƛƕƝƘƕ max ƜƐƚơ 30 mmHg ƜƜ ƠƢ ơƢ Betriebsart High Flow High Flow mode ƀƕƖƘƜ ƠƐƑƞƢƫ High Flow Intrakavitärer Druck Intracavitary pressure ŲƝƣƢƠƘƟƞƛƞơƢƝƞƕ ƔƐƒƛƕƝƘƕ 1 30 mmHg ƜƜ ƠƢ ơƢ Auflösung resolution ƠƐƗƠƕƨƕƝƘƕ 1 mmHg ƜƜ ƠƢ ơƢ Flow Flow ƀƐơƥƞƔ 1 40 l min ƛ ƜƘƝ Auflösung resolution ƠƐƗƠƕƨƕƝƘƕ 1 l min ƛ ƜƘƝ Insufflationsdruck Insufflation pressure ŸƝơƣƤƤƛƯƦƘƞƝƝƞƕ ...

Page 60: ...ype CF 4 Type of IP protection IP21 According to IEC 60601 1 2 FCC B Observe the information on electromagnetic compatibility in chapter 11 pages 56 69 9 3 2 Directive compliance for UI400 According to the Medical Device Directive MDD This medical product belongs to Class IIb This medical product bears the CE mark in accordance with the Medical Device Directive MDD 93 42 EEC 1 NOTE The code number...

Page 61: ...signated as reparable by the manufacturer Supply of such technical documentation relating to the device shall not be construed as constituting manufacturer s authorization of user s personnel regardless of their level of technical training to open or repair the device Explicitly exempted herefrom are those maintenance and repair operations described in this manual 1 NOTE We reserve the right to ma...

Page 62: ...r length 102 cm 20400025 Same length 55 cm 20400029 High pressure tube American connector ISO connector length 102 cm 20400222 CO2 bottle 1 l empty with German connector 26400090 CO2 bottle 1 l empty with PIN Index connector 26400091 Low pressure tube for the central CO2 gas supply length 150 cm UI001 Same length 300 cm UI002 Same length 600 cm UI003 HD Inline gas ǫlter 20400032 Universal wrench 2...

Page 63: ...ed blunt stylet LUER lock length 10 cm 26120 J Same length 12 cm 26120 JL Same length 7 cm 26120 JK Same length 15 cm for creating pneumo peritonea by means of DOUGLAS puncture with adipose patients 26120 JF Bottle holder for the KARL STORZ CO2 bottle UI005 Leakage tester 13242 XL 10 2 Accessories Ersatzteile empfohlenes Zubehör Spare parts recommended accessories ŸƗƔƕƛƘƕ NJ ƗƐƚƐƗƐ ŸƝơƣƤƤƛƯƦƘƞƝƝƐƯ ...

Page 64: ...rgy only for their internal functioning 1 NOTE The tables and guidelines that are included in this appendix provide information to the customer or user that is essential in determining the suitability of the device or system for the electromagnetic environment of use and in managing the electromagnetic environment of use to permit the device or system to perform its intended use without causing in...

Page 65: ...ve an impact on this or other pieces of medical equipment 3 WARNING The use of accessories transducers and cables other than those speciǫed in the KARL STORZ instruction manual may result in increased emissions or decreased immunity of the device The accessories transducers and cables listed below have been shown to comply with the requirements of IEC 60601 1 2 When using accessories transducers a...

Page 66: ...rden HF Aussendungen nach CISPR 11 Klasse B Der ENDOFLATOR 40 Modell UI400 ist für den Gebrauch in allen Einrichtungen einschließlich Wohnbereichen und solchen bestimmt die unmittelbar an ein öffentliches Versorgungsnetz angeschlossen sind das auch Gebäude versorgt die für Wohnzwecke genutzt werden Aussendung von Oberschwin gungen nach IEC 61000 3 2 Klasse A Aussendungen von Spannungs schwankungen...

Page 67: ...e 1 kV Spannung Außenleiter Außenleiter 2 kV Spannung Außenleiter Erde Die Qualität der Versorgungsspannung sollte der einer typischen Geschäfts oder Krankenhausumgebung entsprechen Spannungseinbrüche Kurzzeitunterbrechungen und Schwankungen der Versorgungsspannung nach IEC 61000 4 11 5 UT 95 Einbruch der UT für 1 2 Periode 40 UT 60 Einbruch der UT für 5 Perioden 70 UT 30 Einbruch der UT für 25 Pe...

Page 68: ...eringer als der Übereinstimmungspegel seinb In der Umgebung von Geräten die das folgende Bildzeichen tragen sind Störungen möglich 7 Anmerkung 1 Bei 80 MHz und 800 MHz gilt der höhere Frequenzbereich Anmerkung 2 Diese Leitlinien mögen nicht in allen Fällen anwendbar sein Die Ausbreitung elektromagnetischer Größen wird durch Absorptionen und ReǬexionen der Gebäude Gegenstände und Menschen beeinǬuss...

Page 69: ...80 MHz C 80 MHz bis 800 MHz C 800 MHz bis 2 5 GHz F 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 Für Sender deren maximale Nennleistung in obiger Tabelle nicht angegeben ist kann der empfohlene Schutzabstand d in Metern m unter Verwendung der Gleichung ermittelt werden die zur jeweiligen Spalte gehört wobei P die maximale Nennleistung des Senders in Watt W gemäß...

Page 70: ...tic environment guidance RF emissions CISPR 11 Group 1 The ENDOFLATOR 40 model UI400 uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause interference in nearby electronic equipment RF emissions CISPR 11 Class B The ENDOFLATOR 40 model UI400 is suitable for use in all establishments including domestic establishments and those directly co...

Page 71: ...th Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 seconds 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for...

Page 72: ...s as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with the following symbol 7 Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reǬection by struc...

Page 73: ...cy of transmitter 150 kHz to 80 MHz D 80 MHz to 800 MHz D 800 MHz to 2 5 GHz F 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power ratin...

Page 74: ...Ƣ ŲƇ ƭƝƕƠƓƘƮ ƢƞƛƬƚƞ ƔƛƯ ƒƫƟƞƛƝƕƝƘƯ ƒƝƣƢƠƕƝƝƘƥ ƤƣƝƚƦƘƙ ſƞƭƢƞƜƣ ƣƠƞƒƕƝƬ ƭƜƘơơƘƘ ŲƇ ƟƞƜƕƥ ƯƒƛƯƕƢơƯ ƞƧƕƝƬ ƝƘƗƚƘƜ Ɛ ƝƐƠƣƨƕƝƘƕ ƤƣƝƚƦƘƞƝƘƠƞƒƐƝƘƯ ƠƐơƟƞƛƞƖƕƝƝƞƓƞ ƒƑƛƘƗƘ ƭƛƕƚƢƠƞƝƝƞƓƞ ƞƑƞƠƣƔƞƒƐƝƘƯ ƜƐƛƞƒƕƠƞƯƢƝƫƜ ŲƇ ƘƗƛƣƧƕƝƘƯ ơƞƓƛƐơƝƞ CISPR 11 źƛƐơơ B ſƠƘƑƞƠ ENDOFLATOR 40 ƜƞƔƕƛƘ UI400 ƟƠƘƓƞƔƕƝ ƔƛƯ ƟƠƘƜƕƝƕƝƘƯ ƒ ƛƮƑƫƥ ƜƕơƢƐƥ ƠƐƗƜƕƩƕƝƘƯ ƒƚƛƮƧƐƯ ƖƘƛƫƕ ƔƞƜƐ Ƙ ƗƔƐƝƘƯ ƝƕƟƞơƠƕƔơƢƒƕƝƝƞ ƟƞƔƚƛƮƧƕƝƝƫƕ ƚ ƠƐơƟƠƕƔƕƛƘƢƕƛƬƝƞƙ ...

Page 75: ...ƞƒƐƢƬ ƢƘƟƘƧƝƫƜ ƣơƛƞƒƘƯƜ ƚƞƜƜƕƠƧƕơƚƞƙ ƘƛƘ ƑƞƛƬƝƘƧƝƞƙ ƞƑơƢƐƝƞƒƚƘ żƘƚƠƞơƕƚƣƝƔƝƫƕ ƘƜƟƣƛƬơƝƫƕ ƟƞƜƕƥƘ ƑƞƛƬƨƞƙ ƭƝƕƠƓƘƘ ơƞƓƛƐơƝƞ żƍź 61000 4 5 1 ƚŲ ƝƐƟƠƯƖƕƝƘƕ ƟƠƞƒƞƔ ƟƠƞƒƞƔ 2 ƚŲ ƝƐƟƠƯƖƕƝƘƕ ƟƠƞƒƞƔ ƗƕƜƛƯ 1 ƚŲ ƝƐƟƠƯƖƕƝƘƕ ƟƠƞƒƞƔ ƟƠƞƒƞƔ 2 ƚŲ ƝƐƟƠƯƖƕƝƘƕ ƟƠƞƒƞƔ ƗƕƜƛƯ źƐƧƕơƢƒƞ ƭƛƕƚƢƠƘƧƕơƚƞƙ ƭƝƕƠƓƘƘ ƒ ƭƛƕƚƢƠƘƧƕơƚƞƙ ơƕƢƘ ƗƔƐƝƘƯ ƔƞƛƖƝƞ ơƞƞƢƒƕƢơƢƒƞƒƐƢƬ ƢƘƟƘƧƝƫƜ ƣơƛƞƒƘƯƜ ƚƞƜƜƕƠƧƕơƚƞƙ ƘƛƘ ƑƞƛƬƝƘƧƝƞƙ ƞƑơƢƐƝƞƒƚƘ ſƠƞƒƐƛƫ ...

Page 76: ...ƧƘƚƐ Ɛ d ƠƕƚƞƜƕƝƔƣƕƜƞƕ ƟƠƞơƢƠƐƝơƢƒƕƝƝƞƕ ƠƐƗƝƕơƕƝƘƕ ƒ ƜƕƢƠƐƥ Ɯ ŽƐƟƠƯƖƕƝƝƞơƢƬ ƟƞƛƯ ƟƠƘ ƠƐơƟƠƞơƢƠƐƝƕƝƘƘ ƠƐƔƘƞƒƞƛƝ ƞƢ ơƢƐƦƘƞƝƐƠƝƫƥ ƠƐƔƘƞƟƕƠƕƔƐƢƧƘƚƞƒ Ɵƞ ƠƕƗƣƛƬƢƐƢƐƜ ƝƐƑƛƮƔƕƝƘƙ ƗƐ ƭƛƕƚƢƠƞƜƐƓƝƘƢƝƞƙ ƞƑơƢƐƝƞƒƚƞƙa ƔƞƛƖƝƐ ƑƫƢƬ ƝƘƖƕ ƧƕƜ ƣƠƞƒƕƝƬ ơƞƞƢƒƕƢơƢƒƘƯ ƒ ƚƐƖƔƞƙ Ɵƞƛƞơƕ ƧƐơƢƞƢb ſƞƜƕƥƘ ƜƞƓƣƢ ƘƜƕƢƬ ƜƕơƢƞ ƒƑƛƘƗƘ ƞƑƞƠƣƔƞƒƐƝƘƯ ƜƐƠƚƘƠƞƒƐƝƝƞƓƞ ƗƝƐƚƞƜ 7 ſƠƘƜƕƧƐƝƘƕ 1 ŽƐ ƧƐơƢƞƢƐƥ 80 żųƦ Ƙ 800 żųƦ ƟƠƘƜƕƝƯƮƢ ƑƞƛƬƨƕƕ Ɨ...

Page 77: ...ƕƢƞƜ ƜƐƚơƘƜƐƛƬƝƞƙ ƒƫƥƞƔƝƞƙ ƜƞƩƝƞơƢƘ ơƠƕƔơƢƒ ơƒƯƗƘ ŽƞƜƘƝƐƛƬƝƐƯ ƜƞƩƝƞơƢƬ ƟƕƠƕƔƐƢƧƘƚƐ ŲƢ ſƠƞơƢƠƐƝơƢƒƕƝƝƫƙ ƠƐƗƝƞơ d Ɯ ƒ ƗƐƒƘơƘƜƞơƢƘ ƞƢ ƧƐơƢƞƢƫ ƟƕƠƕƔƐƢƧƘƚƐ ƞƢ 150 ƚųƦ Ɣƞ 80 żųƦ C ƞƢ 80 żųƦ Ɣƞ 800 żųƦ C ƞƢ 800 żųƦ Ɣƞ 2 5 ųųƦ F 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 ŴƛƯ ƟƕƠƕƔƐƢƧƘƚƞƒ ƜƐƚơƘƜƐƛƬƝƐƯ ƝƞƜƘƝƐƛƬƝƐƯ ƜƞƩƝƞơƢƬ ƚƞƢƞƠƫƥ Ɲƕ ƣƚƐƗƐƝƐ ƒ ƟƠƘƒƕƔƕƝƝƞƙ ƒƫƨƕ ƢƐƑƛƘƦƕ Ơ...

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Page 80: ...KARL STORZ GmbH Co KG Mittelstraße 8 78532 Tuttlingen Postfach 230 78503 Tuttlingen Germany Telefon 49 0 7461 708 0 Telefax 49 0 7461 708 105 E Mail info karlstorz com Web www karlstorz com ...