Richard Wolf FLUID CONTROL Lap 2216 Manual
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Richard Wolf FLUID CONTROL Lap 2216 Manual

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FLUID CONTROL Lap 2216

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Summary of Contents for Richard Wolf FLUID CONTROL Lap 2216

  • Page 1 Manual FLUID CONTROL Lap 2216...
  • Page 2 This manual should not be photocopied, duplica- ted 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.
  • Page 3 Symbols Symbols Description Symbols Description Symbols Description Follow instructions for use Verwendbar bis (white image on a blue Temperature limit (JJJJ-MM-TT) background) Consult instructions for use Quantity Humidity limitation Number of autoclaving Atmospheric pressure limi- Caution cycles tation Do not use if package is Type BF applied part Keep dry damaged...

  • Page 5: Table Of Contents

    Table of Contents Important User Notes ................................. 3 General Safety Notes ................................4 General Information ................................5 Device Description ................................... 5 Used as Intended and Contraindications .......................... 5 3.2.1 Intended Use....................................5 3.2.2 Contraindication..................................5 General Warnings and Precautions ............................ 5 3.3.1 General Warnings ..................................

  • Page 7: Important User Notes

    Important User Notes Important User Notes Read the instructions for use carefully and become familiar with the operation and function of the device and the accessories before use during surgical proce- dures. Non-observance of the instructions listed in this manual can lead •...

  • Page 8: General Safety Notes

    The handing over of technical documents does not constitute authorization to make repairs or alterations to the device or accessories. WARNING: Modifying the device FLUID CONTROL Lap 2216 is not permitted. Authorized service technician Only an authorized service technician may perform repairs, adjustments, or al- terations on the device or accessories and use the service menu.

  • Page 9: General Information

    General Information General Information Device Description 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 (non- sterile area). It pumps medical sterile irrigation fluid through a sterile tube. This flushes the corresponding fluids into the body cavity.
  • Page 10 General Information DANGER! Do not touch Avoid touching the roller wheel. Risk of injury! 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 deter- mine the specific technique and procedure that will accomplish the desired clin- ical effect.
  • Page 11 General Information DANGER! Sterile mediums and accessories Always work exclusively with sterile substances and mediums, sterile fluids, and sterile accessories if so indicated. DANGER! Reprocessing of sterile disposable products Infection hazard for patients and/or users and impairment of product function- ality due to reuse.
  • Page 12 General Information DANGER! The product may be used only by doctors or health care professional in accor- dance 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.
  • Page 13 General Information DANGER! Connect only items, that have been specified as part of the ME system or speci- fied as being compatible with ME systems. 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.
  • Page 14 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.

  • Page 15: Precautionary Measures

    General Information DANGER! Additional equipment Additional equipment connected to medical electrical devices must be demon- strated to be compliant with their respective IEC or ISO standards (IEC 60601-1, IEC 60950 or IEC 62368 for data processing equipment). Furthermore, all config- urations must comply with the normative requirements for medical systems (see section 16 of the last valid edition of IEC 60601-1).
  • Page 16 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. 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.

  • Page 17: Device Startup

    Locations The device is only to be used in a professional facility healthcare enviroment. Delivery Scope • Device FLUID CONTROL Lap 2216 • Instructions for Use • Power cord Always check all parts and accessories of the device immediately after receiving Delivery inspection the shipment.
  • Page 18 Device Startup DANGER! Set up the device in such a way as to allow for easy monitoring of the display val- ues, device functions, and access to the control elements. 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...

  • Page 19: Mounting The Pump

    Device Startup Power connection 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.

  • Page 20: Mounting On Stand

    Device Startup 4.3.1 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 DANGER! The position of the device on the stand can affect the stand's stability.

  • Page 21: Mounting On Device Cart

    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 Front of the Device Familiarize yourself with the control and function elements at the front of the de- vice.

  • Page 22: Rear Of The Device

    Device Startup Rear of the Device Familiarize yourself with the connection elements at the rear of the device. (14) (15) Abb. 4-3 Device rear Toggle screw (14) Clamp (15) Spacer (16) Service interface (17) Connection for potential equaliza- (18) (21) tion Mains socket (19)

  • Page 23: Operating The Device

    Operating the Device Operating the Device Function test 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 pack- age to ensure that the packaging is intact and that the expiration date is still val- DANGER! Original accessories...

  • Page 24: Suction Test

    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 in- strument are completely filled with fluid.

  • Page 25: Overview Of The Usable Tube Sets

    Comply with hygiene rules and regulations when disposing of the tube set, col- lected fluid, and the suction container. Overview of the Usable Tube Sets The following table shows an overview FLUID CONTROL Lap 2216 of the tube sets that can be used. Tube category Art.

  • Page 26: Inserting A Tube Set

    Operating the Device Inserting a Tube Set Abb. 5-2 Tube set irrigation elements Roller tube (2) Pressure chamber with membrane (3) Irrigation tube (4) Y-connector (5) Tubing clamps (6) Tap spikes (7) Care-Lock® connectors (8) Protective caps (9) Instrument tube (10) Luer lock connection with protective (10) The irrigation tube set is available as a disposable or reusable tube set (autoclav-...
  • Page 27 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 sterile autoclavable container  Open the sterile autoclavable container of the tube set. ...
  • Page 28 Operating the Device • Disposable tube set: After inserting the tube set and starting the irrigation cy- cle, 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 pow- er failure, the tube set is invalidated.

  • Page 29: Connecting The Irrigation Fluid Bags

    Operating the Device Connecting the Irrigation Fluid Bags 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 vac- uum being generated inside of the bottle. Risk of implosion. Abb.

  • Page 30: Suction

    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 re- lieve the pressure in the tube. After that it stops. Suction Abb. 5-6 Suction system Vacuum tube Hygiene filter...

  • Page 31: Replacing The Suction Container

    Operating the Device Replacing the Suction Container WARNING! Full secretion containers must be replaced immediately without stopping sur- gery. 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).

  • Page 32: Safety Functions

    Safety Functions Safety Functions The electronic components continuously monitor the proper function of the de- vice. Device malfunctions are indicated with audible warning signals (beeps), er- ror messages, and/or by blocking device functions. Pressure Limitation at 400 mmHg The pump generates a max. pressure of 400 mmHg to reach the max. flow capac- ity during the irrigation mode.

  • Page 33: Care And Maintenance

    Care and Maintenance Care and Maintenance Special care is necessary when servicing, maintaining, and storing the device and associated accessories to maintain the functionality of both. Cleaning the Device 1. Use the ON/OFF button to turn the device off. 2. Remove the power cable. 3.

  • Page 34: Sterilizing The Reusable Tube Set

    Care and Maintenance 7.2.3 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.

  • Page 35: Disinfecting Reusable Tube Sets

    Care and Maintenance Automatic cleaning and disinfecting: 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 compatibil- ity using the "Vario"...

  • Page 36: Sterilizing Reusable Tube Sets

    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.

  • Page 37: Annual Inspection

    Care and Maintenance • Additional information 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.

  • Page 38: Changing The Fuse

    Care and Maintenance 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 chap- ter 9 "Technical Data". The fuse may be defective and is in need of replacement if: •...

  • Page 39: Annual Inspection

    Annual Inspection Annual Inspection Each test conducted must be documented with date and signature on the test log Measured values and tolerances (chapter 13 "Test Record"). The following measuring tools and resources were used by the manufacturer to determine the measurements and tolerance levels: Tube set Beaker/meas.

  • Page 40: Suction Test

    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.

  • Page 41: Technical Data

    Technical Data 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]...
  • Page 42 Technical Data Max. negative suction pressure [kPa] Max. suction power [l/min] Max. outlet pressure [mmHg] Max. irrigation output [l/min] Interfaces/ports: Signal input/output Service interface (D-Sub female 9-pin DE-9, only for service, no ESD protec- tion) Power supply IEC-60320-1 C14 RFID transponder technology Transmit/Receive Frequency Range 13.56 MHz ±...

  • Page 43: Accessory List

    Suction container PSU, 3 liters, autoclavable 8170.981 Suction container, 3 liters, disposable item, 2 units in sale pack 2215.971 Holder to fasten suction container to irrigation stand or MUT scales 2215.992 Universal holder for FLUID CONTROL Lap 2216 on RIWOmobil 32114605...

  • Page 44: Electromagnetic Compatibility

    Accessories To ensure compliance with the requirements of IEC 60601-1-2 in the current ver- sion, the device FLUID CONTROL Lap 2216 must be used only with the accessories listed in chapter 10 "Accessory List". To ensure the basic safety and essential functionality in relation to electromag- netic interference over the life of the device, the device must be restarted after 24 hours so that a self-test can be performed.

  • Page 45: Guidelines And Manufacturer's Statement/Electromagnetic Interference Immunity

    Electromagnetic Compatibility 11.4 Guidelines and Manufacturer's Statement/Electromagnetic In- terference Immunity The deviceFLUID CONTROL Lap 2216 is intended for use in an electromagnetic en- vironment 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 IEC 60601-1-2 Concordance...

  • Page 46: Guidelines And Manufacturer's Statement/Electromagnetic Interference Immunity

    Guidelines and Manufacturer's Statement/Electromagnetic In- terference Immunity The device FLUID CONTROL Lap 2216 is intended for operation in an electromag- netic environment as described below. The user of the device FLUID CONTROL Lap 2216 should make sure the device is operated within such an environment.
  • Page 47 If the field strength measured at the usage site of the device FLUID CONTROL Lap 2216 exceeds the compliance levels listed above, the device FLUID CONTROL Lap 2216 should be monitored for proper func- tion.

  • Page 48: Error And Warning Messages

    Error and Warning Messages 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 devia- tion or error in the electronics Short 4 warning beeps are contin- components measuring the pres- uously repeated...
  • Page 49 Error and Warning Messages Error and Warning Messages Cause Troubleshooting After pressing the start key: Red The pump was started without an Insert a new tube into pump before starting. and green tube status LEDs flash inserted tube or the tube was not slowly detected by the pump, e.g.

  • Page 50: Test Record

    Test Record Test Record 13.1 Test Log Date Results Comment Signature...

  • Page 51: Return Form

    Test Record 13.2 Return Form Please fill out this form when returning the device: Name of owner: Sales partner: Address of person returning unit: Street: House number: ZIP/Postal code: City: Country: IMPORTANT! Serial number (see identification plate): Device type: Description of defect: Contact Signature Date...

  • Page 52: Glossary

    Glossary Glossary Term Explanation Transponder RFID transponders are wireless communication and monitoring devices that receive and automatically respond to signals. The term transponder is a mix- ture of "transmitter" and "responder." Transponders can be active or passive. RFID RFID (Radio Frequency Identification) is an auto- mated identification process that makes it possible to detect objects without touching them and to log or acquire and save data automatically.

  • Page 53: Index

    Index Index Authorized service technician 4 Authorized trained personnel 33 Autoclave sterilization 30 Care and maintenance 4 Certification 33 Connect instrument 23 Contamination 4 Delivery inspection 13 Disposal 4 ESD (Electrostatic Discharge) precautionary measures 40 Essential Performance 5 Exclusion of liability 4 Federal Law 4 Gas sterilization 30 Insert tube set 23...
  • Page 56 +43 14 05 51 51 45 endoscopes@richardwolf.fr info@richard-wolf.at www.richard-wolf.at Marketing Office INDIA U.A.E RICHARD WOLF India Private Ltd. RICHARD WOLF Middle East JMD Pacific Square P.O. Box 500283 No. 211 A, Second Floor AL Thuraya Tower 1 Behind 32 Milestone...

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