Manual FLUID CONTROL Lap 2216 en
en This manual contains information that is subject to copyright. All rights reserved. This manual should not be photocopied, duplicated on microfilm or otherwise copied or distributed, completely or in part, without the approval of RICHARD WOLF GmbH. We reserve the right to technical changes without prior notification due to thecontinuous further development of our products. Function or design may partially differ from the description in the manual.
Symbols Symbols Description Symbols Description Symbols Description Follow instructions for use (white image on a blue background) Verwendbar bis (JJJJ-MM-TT) Temperature limit Consult instructions for use Quantity Humidity limitation Caution Number of autoclaving cycles Atmospheric pressure limitation Type BF applied part Keep dry Do not use if package is damaged Equipotentiality Not made with phthalates Recycling PAP PE Degrees of protection provided by enclosures (IPCode) Contains
Table of Contents 1 Important User Notes ......................................................................................................................................................... 3 2 General Safety Notes .......................................................................................................................................................... 4 3 General Information ............................................................................................................
Important User Notes 1 Important User Notes en Read the instructions for use carefully and become familiar with the operation and function of the device and the accessories before use during surgical procedures. Non-observance of the instructions listed in this manual can lead • to life-threatening injuries of the patient, • to severe injuries of the surgical team, nursing staff or service personnel, or • to damage or malfunction of device and/or accessories.
General Safety Notes en 2 General Safety Notes Federal Law (only for U.S. market) CAUTION: Federal Law restricts this device to sale by or on the order of a physician.
General Information 3 General Information 3.1 Device Description en The device FLUID CONTROL Lap 2216 is a pump with an irrigation and suction function for laparoscopy. The device itself is non-invasive and designed for use in multi-unit racks (nonsterile area). It pumps medical sterile irrigation fluid through a sterile tube. This flushes the corresponding fluids into the body cavity. The device can be used with electrolyte-free media (such as glycine 1.5% or sorbitol 3.
General Information DANGER! Do not touch Avoid touching the roller wheel. Risk of injury! en DANGER! Technique and procedures Only the physician can evaluate the clinical factors involved with each patient and determine if the use of this device is indicated. The physician must determine the specific technique and procedure that will accomplish the desired clinical effect.
General Information DANGER! Sterile mediums and accessories Always work exclusively with sterile substances and mediums, sterile fluids, and sterile accessories if so indicated. en DANGER! Reprocessing of sterile disposable products Infection hazard for patients and/or users and impairment of product functionality due to reuse. Risk of injury, illness or death due to contamination and/or impaired functionality of the product! Do not reprocess the product.
General Information DANGER! The product may be used only by doctors or health care professional in accordance with the intended use. Personnel must have training that qualifies them to operate laparoscopy pumps. In addition, personnel must read the user manual and operating instructions and become familiar with handling the device before first use. Personnel must have mastered handling and operation of the product before first use during a surgery.
General Information DANGER! Connect only items, that have been specified as part of the ME system or specified as being compatible with ME systems. en DANGER! Please read the instruction manual for the stand before mounting the pump on the stand. DANGER! The position of the device on the stand can affect the stand's stability. If the device is mounted too high on the stand, the stand may tilt or topple.
General Information DANGER! The reusable tube set is made of silicone, polysulfone (PSU), and stainless steel. For cleaning and disinfection, use only pH-neutral or slightly alkaline cleaning agents (e.g. neodisher MediClean 2.0 %), disinfectants (e.g. Lysetol V 8 %), and drying and rinsing agents approved for the tube set materials. Using unsuitable agents (e.g. neodisher MediKlar rinsing agent) may damage the tube system and especially the PSU connectors.
General Information DANGER! Additional equipment Additional equipment connected to medical electrical devices must be demonstrated to be compliant with their respective IEC or ISO standards (IEC 60601-1, IEC 60950 or IEC 62368 for data processing equipment). Furthermore, all configurations must comply with the normative requirements for medical systems (see section 16 of the last valid edition of IEC 60601-1).
General Information WARNING! Patient group There are no restrictions as to the specification of the patient group when using the device as intended and its use does not endanger the patient's health. en WARNING! Electrical Interference (See chapter 11 "Electromagnetic Compatibility"). Electrical interference with other devices or instruments was practically eliminated when developing this devices and none was detected during testing.
Device Startup 4 Device Startup en DANGER! The product may be used only by doctors or health care professional in accordance with the intended use. Personnel must have training that qualifies them to operate laparoscopy pumps. In addition, personnel must read the user manual and operating instructions and become familiar with handling the device before first use. Personnel must have mastered handling and operation of the product before first use during a surgery.
Device Startup DANGER! Set up the device in such a way as to allow for easy monitoring of the display values, device functions, and access to the control elements. en DANGER! Position the device in such a way that it is easy to operate and switch off. DANGER! Risk of electrical shock To avoid the risk of electrical shock, only use this device when connected to a properly grounded power supply network.
Device Startup Power connection en WARNING! Check to make sure the available mains voltage matches the data listed on the type label attached to the back of the device. Incorrect voltage can cause errors and malfunctions and may destroy the device. Make sure the connection data and technical specifications of the power supply comply with DIN VDE or national requirements. The mains connection cable must be plugged into a properly installed, grounded shockproof safety wall socket.
Device Startup 4.3.1 en Mounting on Stand DANGER! Please read the instruction manual for the stand before mounting the pump on the stand. NOTE! Make sure the rod of the stand has a diameter of 20-30 mm. Abb. 4-1 Mounting on the stand h DANGER! The position of the device on the stand can affect the stand's stability. If the device is mounted too high on the stand, the stand may tilt or topple.
Device Startup 4.3.2 Mounting on Device Cart en DANGER! Please read the instruction manual for the device cart before mounting the pump on the cart. Detail mounting on device cart, rear Modell Richard Wolf 4.4 Front of the Device Familiarize yourself with the control and function elements at the front of the device. (1) (2) (3) (4) Abb.
Device Startup 4.5 en Rear of the Device Familiarize yourself with the connection elements at the rear of the device. Abb.
Operating the Device 5 Operating the Device 5.1 Function test en DANGER! Functional test The functional test must be performed prior to each surgery. DANGER! Sterilize reusable instruments and tubing before surgery to prevent infections. Check all the single-use/disposable items before removing them from the package to ensure that the packaging is intact and that the expiration date is still valid.
Operating the Device 1. Connect the instrument. Close stopcock if using instrument with stopcock. 2. Press the irrigation start/stop key. The irrigation LED lights up. 3. Operate the trumpet valve or open the stopcock. Make sure tube set and instrument are completely filled with fluid. Remove all air from tube and instrument. 4. Release the trumpet valve or close the instrument stopcock. en 5.1.3 Suction Test 1. Close stopcock if using instrument with stopcock. 2.
Operating the Device 1. Tube set and instrument are filled with irrigation fluid. The suction system is connected. The stopcocks are closed. 2. Press the suction start/stop key (LED lights up). The suction system is pre-evacuated. Only then can the suction procedure be started with the instrument. Before surgery 1. Press the irrigation start/stop key (LED lights up). 2. Insert instrument into abdomen. Start irrigating wash: Operate the trumpet valve or open the stopcock. 3.
Operating the Device 5.4 en Abb. 5-2 (1) Inserting a Tube Set (8) Tube set irrigation elements Roller tube (7) (6) (2) Pressure chamber with membrane (3) Irrigation tube (4) Y-connector (5) Tubing clamps (5) (6) Tap spikes (7) Care-Lock® connectors (8) Protective caps (4) (9) Instrument tube (10) Luer lock connection with protective cap (1) (2) (3) (9) (10) The irrigation tube set is available as a disposable or reusable tube set (autoclavable).
Operating the Device A sterile technician then removes the inner tube set package and opens it. 1b. Reusable tube set - To be carried out by non-sterile technician: Open the sterile autoclavable container of the tube set. A sterile technician then removes the tube set from the inside of the package. Open sterile autoclavable container 2. Sterile tasks Keep the Luer lock connector (10) in the sterile area and hand the tube end with the tap spikes (6)/Care-Lock® (7) to the non-sterile personnel.
Operating the Device • Disposable tube set: After inserting the tube set and starting the irrigation cycle, the tube set is invalidated. If the irrigation cycle is stopped, the device can be restarted within 45 minutes. If the device is switched off or in case of a power failure, the tube set is invalidated. The irrigation cycle can no longer be started. If this is the case, you must insert a new, valid, and approved tube set.
Operating the Device 5.5 Connecting the Irrigation Fluid Bags en DANGER! The device is only intended for use with flexible fluid containers. Do not use glass containers as they might break. Fluid cannot flow quickly enough due to the vacuum being generated inside of the bottle. Risk of implosion. (1) Abb.
Operating the Device 7. Press the irrigation start/stop key again (LED goes out). The tube is now relieved of pressure. The roller wheel turns backwards to relieve the pressure in the tube. After that it stops. en 5.7 Abb. 5-6 (1) Suction system (1) Vacuum tube (2) Hygiene filter (3) Suction container (4) Drain tube (5) Instrument Suction (2) (3) (4) (5) The suction system consists of the following: 1. 2. 3.-4.
Operating the Device 5.8 Replacing the Suction Container en WARNING! Full secretion containers must be replaced immediately without stopping surgery. If the overflow protection of the secretion containers is triggered, suction is stopped to prevent the ingress of fluids. 1. Stop the suction (see chapter 5.7 "Suction"). Press the suction start/stop key (LED goes out). 2. Actuate the trumpet valve or open the stopcock to vent the system. 3. Remove tubes from filled suction container. 4.
Safety Functions 6 en Safety Functions The electronic components continuously monitor the proper function of the device. Device malfunctions are indicated with audible warning signals (beeps), error messages, and/or by blocking device functions. 6.1 Pressure Limitation at 400 mmHg The pump generates a max. pressure of 400 mmHg to reach the max. flow capacity during the irrigation mode.
Care and Maintenance 7 Care and Maintenance en Special care is necessary when servicing, maintaining, and storing the device and associated accessories to maintain the functionality of both. 7.1 Cleaning the Device 1. Use the ON/OFF button to turn the device off. 2. Remove the power cable. 3. Wipe the surface of the device with a soft cloth moistened with the surface disinfectant based on alcohol or aldehyde (for example Meliseptol® rapid).
Care and Maintenance 7.2.3 en Sterilizing the Reusable Tube Set The maximum number of sterilization cycles for the tube set is determined by the manufacturer (see tube packaging). WARNING! Never exceed the number of uses recommended by the manufacturer. NOTE! The last (20th) use of the tube set is indicated by the flashing green tube status LED after pressing the stop key. This tube set cannot be reused even if sterilized.
Care and Maintenance Automatic cleaning and disinfecting: en The cleaning and subsequent disinfection of the individual components of the tube sets can be carried out with the appropriate programmable cleaning and disinfecting equipment for medical devices. The manufacturer has validated the applicability of this method in terms of hygiene success and material compatibility using the "Vario" program of the disinfector manufactured by the company Miele.
Care and Maintenance 3. Place the components once more in demineralized water (room temperature, 20 °C to 30 °C) for a period of at least 3 minutes to 5 minutes and then rinse them off under running water. Make sure all disinfectant residue is removed from the individual parts of the tube set. 4. Flush the silicone tube for 15 seconds with demineralized water. Then use a high-pressure cleaning gun to emit 10 pressure surges, each one with a length of one second (1 second) into the silicone tube. 5.
Care and Maintenance • Additional information en When sterilizing several tube sets, instruments, etc. with one sterilization cycle, make sure not to exceed the max. load of the sterilizer. Sterilization with ethylene oxide (ETO) is possible but has not been approved by the manufacturer. 7.4 Annual Inspection The manufacturer stipulates that qualified personnel or hospital technicians must regularly test the device to assess its functionality. These tests must be performed on an annual basis.
Care and Maintenance 7.6 en Changing the Fuse DANGER! Replacing fuse Replace the fuse only with a fuse of the same type and rating. WARNING! Before replacing the fuse, check the values of the fuse to be inserted acc. to chapter 9 "Technical Data". The fuse may be defective and is in need of replacement if: • displays and LEDs (if available on your equipment) do not light up, • the device does not function.
Annual Inspection 8 Annual Inspection Each test conducted must be documented with date and signature on the test log (chapter 13 "Test Record"). en Measured values and tolerances The following measuring tools and resources were used by the manufacturer to determine the measurements and tolerance levels: Tube set Beaker/meas. cup With scaling up to 2.0 l 2 irrigation fluid bags Suction tubes Vacuum tube, drain tube Suction container 3.
Annual Inspection 3. Connect the irrigation tube with both irrigation fluid bags. The fluid bags have to be suspended 1.0 m above the device. Do not connect an instrument. 4. Start irrigating wash: Press the irrigation start/stop key (LED lights up). 5. Fill tube set completely with fluid. 6. Clamp off tube set at instrument outlet. 7. Keep the tube set disconnected until the pump stops and thus the pressure limit of the pump works. en Testing 1. Empty measuring cup. 2.
9 Technical Data en Type designation: FLUID CONTROL Lap 2216 Manufacturer Information RICHARD WOLF GmbH Pforzheimer Straße 32 75438 Knittlingen, Germany www.richard-wolf.com info@richard-wolf.com Software version The software can be read by certified service technicians. Mains voltage range [V~]: 100-240 Supply frequencies [Hz] 50/60 Fuse designation: T3,15 AH, 250 V, UL-recognized, slow blow Power consumption: Current [A] Power consumption [VA] Normal operation 100 V 0.
Technical Data en Max. negative suction pressure [kPa] -60 Max. suction power [l/min] 2.0 Max. outlet pressure [mmHg] 400 Max. irrigation output [l/min] 2.0 Interfaces/ports: Signal input/output Service interface (D-Sub female 9-pin DE-9, only for service, no ESD protection) Power supply IEC-60320-1 C14 Transmit/Receive Frequency Range 13.56 MHz ± 0.424 MHz Transceiver class Class I RF Output Power -10.83 dBμA/m at 10 m/32.
Accessory List 10 Accessory List Accessories en Order Number Irrigation tube set with tapping spike, with Luer lock connection, auto- 8171223 clavable, incl. 10 replacement diaphragms Irrigation tube set with tap spike L 3M, with Luer lock connector, sterile disposable item, 10 units in sale pack 4171223 Hygiene tube set with Care-Lock L 3M, sterile disposable item, 10 units in sale pack 4171224 Suction tube set L 3M, with connection piece for handle 8385.901, incl.
Electromagnetic Compatibility en 11 Precautionary measures Electromagnetic Compatibility Medical devices are subject to special safety and protective measures concerning electromagnetic compatibility (hereafter abbreviated as EMC). This device is to be used only for the purposes described in the manual and has to be installed, set up, and operated in compliance with the EMC notes and instructions.
Electromagnetic Compatibility 11.4 Guidelines and Manufacturer's Statement/Electromagnetic Interference Immunity en The deviceFLUID CONTROL Lap 2216 is intended for use in an electromagnetic environment as described below. The user/operator of the device FLUID CONTROL Lap 2216 must make sure the device is operated within such an environment.
Electromagnetic Compatibility 11.5 en Guidelines and Manufacturer's Statement/Electromagnetic Interference Immunity The device FLUID CONTROL Lap 2216 is intended for operation in an electromagnetic environment as described below. The user of the device FLUID CONTROL Lap 2216 should make sure the device is operated within such an environment.
Electromagnetic Compatibility a The field strength of stationary transmitters, such as base stations of wireless phones and cell phones, ham radio operators, AM and FM radio and TV stations theoretically cannot always be determined in advance. A study of the installation site should be considered to determine the electromagnetic environment concerning the stationary transmitter.
Error and Warning Messages 12 en Error and Warning Messages Error and Warning Messages Cause Troubleshooting Device error All LEDs flash rapidly Electronics defective Short warning beeps, 1x or 2x, are continuously repeated All LEDs flash rapidly Sensor errors: Impermissible deviation or error in the electronics Short 4 warning beeps are contin- components measuring the presuously repeated sure. Pressure on sensor while no Turn the device off and back on after approx. 10 sectube is inserted. onds.
Error and Warning Messages Error and Warning Messages Cause Troubleshooting After pressing the start key: Red and green tube status LEDs flash slowly The pump was started without an inserted tube or the tube was not detected by the pump, e.g. defective transponder. Insert a new tube into pump before starting. Warning beep, 1x short en Device information Green tube status LED lights up Tube OK - irrigation can be started All LEDs light up briefly and then go out Self-test concluded successfully.
Test Record en Date 46 Results 13 Test Record 13.
Test Record 13.
Glossary 14 en Glossary Term Explanation Transponder RFID transponders are wireless communication and monitoring devices that receive and automatically respond to signals. The term transponder is a mixture of "transmitter" and "responder." Transponders can be active or passive. RFID RFID (Radio Frequency Identification) is an automated identification process that makes it possible to detect objects without touching them and to log or acquire and save data automatically.
Index Index en A Authorized service technician 4 Authorized trained personnel 33 Autoclave sterilization 30 C Care and maintenance 4 Certification 33 Connect instrument 23 Contamination 4 D Delivery inspection 13 Disposal 4 E ESD (Electrostatic Discharge) precautionary measures 40 Essential Performance 5 Exclusion of liability 4 F Federal Law 4 G Gas sterilization 30 I Insert tube set 23 L Liability 33 M Manufacturer’s specifications 33 Measured values and tolerances 35 O Open outer packaging 22 Open ster
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DE GERMANY RICHARD WOLF GmbH 75438 Knittlingen Pforzheimerstr. 32 Telephone: +49 70 43 35-0 Telefax: +49 70 43 35-300 MANUFACTURER USA RICHARD WOLF Medical Instruments Corp. 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Telephone: +1 84 79 13 11 13 Telefax: +1 84 79 13 14 88 info@richard-wolf.com www.richard-wolf.com sales&marketing@richardwolfusa.com www.richardwolfusa.com UK RICHARD WOLF UK Ltd.
