Page 1
Instruction Manual Ultrasound Generator 2271 GA- -A 181 / en / Index: 09--05--5.0 / ÄM: KG 04--252...
Page 2
Failure to observe can result in damage to the product or surrounding. NOTE! Tips for optimum use and other useful information. GERMANY RICHARD WOLF GmbH RICHARD WOLF RICHARD WOLF UK Ltd. D- -75438 Knittlingen Medical Instruments Corp. Waterside Way Pforzheimerstr. 32 353 Corporate Woods Parkway Wimbledon Tel.: (..49)- -(0)7043- -35- -0...
General information Symbols Meaning Symbols Attention, consult ACCOMPANYING DOCUMENTS Off (disconnection from mains/power) On (connection to mains/power) Equipotentality Fuse µ Alternating current (AC) TYPE BF APPLIED PART Intensity preselection, stage III Intensity preselection, stage II Intensity preselection, stage I Fault indicator “Generator malfunction” warning lamp Fault indicator ”Transducer malfunction”...
Intended use The ultrasound generator (US--LITHO) 2271 with transducer and sono- trode is used in intracorporeal ultrasound lithotripsy exclusively for desin- tegrating kidney stones, urinary bladder stones and ureter stones under direct endoscopic view. The use of this device for purposes other than the above is not admissible.
If connected via a joint mains/power cord under normal conditions the earth leakage current of the system must not exceed 500 µA (300 µA for systems in acc.with UL 60601- -1). e.g. Richard Wolf Video Trolley with ”isolating transformer”. GA--A 181...
Electromagnetic compatibility (EMC) NOTE: The device or system in the following called product always relates to the ultrasound generator 2271 Guidance and manufacturer’s declaration - - electromagnetic emissions The product is intended for use in the environment specified below. The user should assure that the product is used in such an environment.
Page 9
Guidance and manufacturer’s declaration - - electromagnetic immunity for products that are not life- -supporting The product is intended for use in the environment specified below. The user should assure that the product is used in such an environment. Compliance Immunity test IEC 60601 test levels Electromagnetic environment - - guidance...
Illustration Front panel 2.1.1 Legend Power switch with green LED “Foot switch actuated” indicator lamp Socket for foot switch “Transducer malfunction” warning lamp Connection bar for transducer “Generator malfunction” alarm lamp Intensity button for power stage preselection GA--A 181...
Set up WARNING! This device is not protected against explosions. Explosion hazard. Do not operate this device in areas where there is a danger of explosions. CAUTION! Danger of faults and malfunctions. To guarantee the safety of the user, the patient and others use only accessories and spare parts specified by the manufacturer of this product.
Preparation when using Suction Pump 2207 WARNING! Danger of life threatening embolism due to wrong connection of pump tubes. When using a peristaltic suction pump (e.g. Suction Pump 2207) no air or liquid must be discharged from the sonotrode tip. The sonotrode tube only serves for evacuation purposes.
3.1.3 Rear panel connectors Z The local mains/grid voltage and frequency must be the same as indi- cated on “identification plate” (11). Z Connect the supplied power cord to “power input connector” (8) of the Ultrasound Generator and the other end to the wall socket. Z Connect the control output of the Ultrasound Generator to the control input of the Suction Pump using connection cable 2207.991 (20).
Checks IMPORTANT! Run through these checks before every use. Visual check Z Check devices, connectors and cables for correct setup and assembly in accordance with the instruction manual(s). Z Check all device connections and plug--and--socket connectors for tightness, cleanliness and damage. Z Check all connection cables and tubes for damage, hygenic condition and completness.
4.2.2 Ultrasound Generator and Suction Pump Z Connect the transducer to the Ultrasound Generator. Z Connect the suction tube of the pump to the transducer. Z Place the sonotrode of a transducer in a suitable container (N) filled with sterile liquid or irrigation fluid. Z Switch on the Ultrasound Generator and Suction Pump.
The Ultrasound Generator 2271 automatically adapts to the resonance frequency of this oscillating system. Actuating the footswitch supplies an output voltage to the transducer out- put of the device.
Operation of Ultrasound Generator CAUTION! Danger of overload and fracture of the sonotrode. Using the sonotrode at a higher power setting than the maximum permissible power stage can lead to premature material fatigue and fracture of the sonotrode. It is not permissible using the sonotrodes at higher power stages than the maximum permissible power stage indicated.
5.3.1 Controls and indicators of Ultrasound Generator 2271 (US- -LITHO) The Ultrasound Generator is switched on and off by means of mains/ power switch (1) with green LED. To preselect the required power stage, actuate the corresponding inten- sity button (4).
5.3.3 “Intensity” preselection (power stage) CAUTION! Danger of overload and fracture of the sonotrode. Using the sonotrode at a higher power setting than the maximum permissable power stage can lead to premature material fatigue and fracture of the sonotrode. It is not permissable using the sonotrodes at higher powers stages than the maximum permissable power stage indicated.
Changing the sonotrode CAUTION! Danger if a damaged or non- approved sonotrode is used. Using the device with damaged sonotrodes or sonotrodes which are not approved for this device is not permissible. Replace sonotrodes immediately, use only sonotrode models ap- proved for this device by R.Wolf and which are sterilized and in per- fect technical condition.
5.4.2 Changing the sonotrodes The sonotrodes are connected to the transducer through the fine thread on the adapter flange. To ensure a reliable transmission of the sound en- ergy generated in the transducer to the sonotrode, neither the thread nor the flange surfaces of the sonotrode or transducer must have any resi- dues or damage on them, and the threaded connection must be suffi- ciently tight.
Operation in the RIWO NET SYSTEM Combination with RIWO NET SYSTEM Via the integrated CAN--BUS interface the ultrasound generator 2271can be integrated into the R.Wolf RIWO NET SYSTEM. Only the components approved for use with the RIWO--NET--SYSTEM must be connected to the “CAN--BUS” interface. The components must meet the requirements of the latest instruction manual for the RIWO--NET--SYSTEM, section on “Combinations”.
Connection to the RIWO NET SYSTEM Touch- -Screen Monitor RS- -232 z.B. Video printer Control computer Connection of headset microphone RIWO CONTROL z.B. Video recorder RS- -232 CAN- -BUS e.g. Ultrasound generator CAN- -BUS e.g. Light projector CAN- -BUS e.g. Camera CAN- -BUS termination IMPORTANT!
Controlling the devices using the RIWO- -NET menu 6.4.1 Controlling the devices via the different input media Via Touch- -Screen Monitor: -- The function is selected and executed by gently touching the desired menu function (button) directly on the Touch--Screen Monitor. Via voice control: -- The same instructions/commands must be used as displayed on the Touch--Screen Monitor.
6.4.3 Main menu The main menu lists all devices connected to the RIWO NET SYSTEM. Selecting a device calls up and displays the corresponding device menu. 6.4.4 Ultrasound output function Z The “Ultrasound output” menu item serves to preselect the output power stage 1, 2 or 3 of the ultrasound transducer.
Reprocessing and maintenance Reprocessing of device WARNING! Danger if moisture enters in the device. Danger of electric shock. Before reprocessing, the device must be switched off and discon- nected from the mains/power supply. The device can be cleaned with a soft cloth soaked with surface disinfec- tant, alcohol or spirit.
Reprocessing of accessories CAUTION! Danger of infection due to unsterile parts and accessories. Sterilize reprocessible parts and accessories before use. Follow the regulations on sterilization valid in your country. IMPORTANT! Follow the procedures described in the “General instructions and notes on the reprocessing of R. Wolf products, accessories and devices”...
7.2.3 Manual cleaning Prior to disinfection, clean and dry disassembled accessory items manu- ally as follows: Z Transducer: Clean transducer (15) and rinse transducer channel with a cleaning gun. Clean the transducer with a suitable cleaning rod (2167.508) first from the distal end, then from the proximal end (tube connector).
7.2.5 Disinfection For disinfection, immerse accessories in disinfectant solution. Before you immerse the parts fill the channels of the transducer, sonotrode and suc- tion tube completly with disinfectant using a syringe. Follow the disinfectant manufacturer’s instructions! After disinfection dry the channels of the accessory items with com- pressed air and the surfaces with a sterile cloth.
Maintenance of device and accessories Maintenance NOTE! In your correspondence please always specify the model/type and series number indicated on the identification plate. If required further documen- tation is available from the manufacturer. 7.4.1 Maintenance intervals IMPORTANT! To prevent damage that results from ageing and wear of the device and the accessories maintenance must be carried out at adequate intervals.
7.5.2 Visual check Z Check the device setup, connection and connection cable for correct- ness in accordance with section 3 of this manual. 7.5.3 Functional checks CAUTION! Danger of transducer or sonotrode overheating. The transducer must only be activated if irrigation fluid is pumped off through the sonotrode at the same time.
NOTE! The drilling performance of the sonotrode can be tested with the help of a test item (surgically removed kidney stone or comparable material). For the test, use the same setup and procedure as described under “trans- ducer/sonotrode function check” as well as the following test routine: Z Prepare the Ultrasound Generator and Suction Pump as for the func- tion tests of the transducer and sonotrode.
Technical description Trouble shooting IMPORTANT! If you cannot eliminate the faults with the help of this table, please con- tact the service department or return the device for repair. ' Do not attempt to do any repairs yourself! 8.1.1 Device faults Fault/error Possible cause Remedy...
8.2.1 Electrical connection Voltage Frequency Power Current Fuse Model/type consumption rating µ 2271.001 50 / 60 T 1.25 L 2271.002 50 / 60 T 2.50 L 2271.003 110 / 115 50 / 60 T 2.50 L 2271.004 120 / 127 50 / 60 T 2.50 L...
8.2.4 Technical data of transducer (2271.501) Protection against electric shock BF type applied part Degree of protection against the ingression of liquids IP 67 Degree of protection in the presence of flammable This device is not protected against explosions. gasses...
Ear plugs (Ear protection, pack of 10) 2030.12 Foot switch 2271.501 Transducer 74003.009 Open end wrench (size inch) In addition for 2271.10x: 103.701 CAN BUS connection cable, length 0.6 m Probes for Nephroscopy Units Model/type Designation 8962.519 Sonotrode (dia. 1.9 mm, working length 361 mm, straight) 8962.524...
Replacing parts 8.5.1 Device fuses CAUTION! The specification of the fuses in the device must correspond with the fuse ratings on the identification plate. Use only the fuses specified in the spare parts list. L Device power connector with fuse holder Z Switch off the device and disconnect the power cable from both the wall socket and the device connector.
Literature IMPORTANT! As we cannot provide a comprehensive bibliography we would ask users to keep themselves informed of all new developments in this field. Z Atlas der urologischen Endoskopie Band 2: Diagnostik und operative Endoskopie Hans Joachim Reuter 1984, Georg Thieme Verlag Stuttgart, New York Z Extra- - und Intrakorporale Lithotripsie Ch.
Need help?
Do you have a question about the 2271 and is the answer not in the manual?
Questions and answers