Olympus OFP-2 Instructions Manual
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Olympus OFP-2 Instructions Manual

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INSTRUCTIONS
OLYMPUS FLUSHING PUMP
OFP-2
and
WATER CONTAINER
MAJ-1603
USA: CAUTION: Federal law restricts this device to sale by or on the order of a
physician.

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  • Page 1 INSTRUCTIONS OLYMPUS FLUSHING PUMP OFP-2 WATER CONTAINER MAJ-1603 USA: CAUTION: Federal law restricts this device to sale by or on the order of a physician.

  • Page 3: Table Of Contents

    Checking the Package Contents ....Checking the OFP-2 package contents ....
  • Page 4 ..........System chart ................. FLUSHING PUMP OFP-2...

  • Page 5: Important Information - Please Read Before Use

    Important Information — Please Read Before Use Intended purpose Intended use and indications The Olympus OFP-2 Flushing Pump is a peristaltic pump intended to supply fluid to compatible Olympus endoscopes or endotherapy devices for irrigation of the gastric and colonic mucosa during endoscopic or endotherapeutic procedures, allowing improved visualisation, diagnosis and treatment.

  • Page 6: Contact

    Fully explain to the patient the potential benefits and risks of the endoscopy and endoscopic treatment as well as any examination/treatment methods that can be performed in its place, and perform the endoscopy and endoscopic treatment only after obtaining the consent of the patient. FLUSHING PUMP OFP-2...

  • Page 7: Instruction Manual

    If you have any questions or comments regarding the information in this manual, please contact Olympus. These instructions should be retained for reference during the life of the product. Instrument compatibility Refer to the “System chart”...

  • Page 8: Warnings And Cautions

    3.1 (equivalent to EN 60601-1:2006 + A1:2013). WARNING • Explosion hazard - never install or use the OFP-2 within the zone of risk of flammable gases. • The OFP-2 should only be used in a medical facility under the direction of a trained physician.
  • Page 9 • The Remote Control socket on the rear of the unit is for the exclusive connection of compatible Olympus equipment, as shown in the "System chart" in the Appendix. Connection to other equipment could compromise the safety of the system.
  • Page 10 Important Information — Please Read Before Use • The Olympus OFP-2 is a medical device that requires safety measures in regards to EMC. The device must be installed and put into operation in accordance with the EMC information listed in “Operating instructions”...
  • Page 11 • In the event of equipment failure, an alternative method of irrigation should be used in accordance with the endoscope instruction manual. • During use, do not obstruct the vents in the base and rear of the OFP-2 • The OFP-2 should not be positioned where the water container is...
  • Page 12 • Ensure that the OFP-2 is not used adjacent to or stacked with other equipment (other than components of the OFP-2 or the endoscopy system) to avoid electromagnetic interference.

  • Page 13: Chapter 1 Checking The Package Contents

    Chapter 1 Checking the Package Contents 1.1 Checking the OFP-2 package contents Unpack the OFP-2 and associated items from the packaging and confirm that all items in the standard set are present. Contact your Olympus service centre or nearest Olympus office if any parts are damaged or missing.

  • Page 14: Checking The Maj-1603 Package Contents (If Purchased Separately)14

    1.2 Checking the MAJ-1603 package contents (if purchased separately) Unpack the MAJ-1603 and associated items from the packaging and confirm that all items in the standard set are present. Contact your Olympus service centre or nearest Olympus office if any parts are damaged or missing.

  • Page 15: Accessories

    Increases “” or decreases “’’ the flow of water to the endoscope or the EndoTherapy device by pressing the  and  switches as required. The flow rate is stored in memory until the unit is switched OFF. FLUSHING PUMP OFP-2...

  • Page 16: Rear Panel

    Enables the OFP-2 to be remotely controlled from other compatible Olympus equipment via the MAJ-920 remote control cable. Mains power inlet Connects the OFP-2 to the mains power supply using the IEC power cord provided. The Mains power inlet is fitted with two integral fuses. 2.3 Symbols and labels...
  • Page 17 Federal (USA) law restricts this device to sale by or on the order of a physician CE marking indicating that the device is in conformity with the applicable requirements set MDR (EU) out in applicable European Union harmonization 2017/745 legislation Temperature limit ISO 15223-1 FLUSHING PUMP OFP-2...
  • Page 18 European Electrical and Electronic Equipment (WEEE), this Directive symbol indicates that the product must not be disposed of as unsorted municipal waste, but 2002/96/EC should be collected separately Stand-by IEC 60417-5009 Mains power ON/OFF switch IEC 60417-5010 FLUSHING PUMP OFP-2...
  • Page 19 Appliances and Materials Safety Act) Japan Refer to instructions for use ISO 7010-M002 Consult instructions for use ISO 15223-1 Indicates the unit has been independently ETL CLASSIFIED assessed for compliance with AAMI ES60601-1 EN 60601 and CSA standards FLUSHING PUMP OFP-2...
  • Page 20 ISO 7000 Authorized representative in the European ISO 15223-1 Community / European Union UKCA Marking indicating that the device is in conformity with the applicable requirements set MHRA 0086 out in the applicable UK legislation. Importer ISO 7000 FLUSHING PUMP OFP-2...

  • Page 21: Chapter 3 Preparation For Use

    Refer to the workstation instructions for rear panel removal/replacement and manoeuvring details. Referring to Figure 3.1, place the OFP-2 on the base shelf of the mobile workstation to the right hand side, allowing room for a suction pump to be placed on the left.
  • Page 22 CAUTION • For endoscope, use only sterile water. For EndoTherapy device, use only sterile saline. Sterile water should be degassed if the OFP-2 is to be used with an ultrasound endoscope. Use of non-sterile fluid may cause an infection risk to the patient.
  • Page 23 Disinfection and sterilization are not available. If the tube is not replaced after one day 2. MAJ-1608 use, it may cause contamination. Auxiliary channel After one day use Disinfection and sterilization are not water tube (0.75m) available. FLUSHING PUMP OFP-2...
  • Page 24 Disinfection and sterilization are not available. For water container use, refer to Figure 3.4 and push the open end of the tube into the water container up to the indicator line noting the orientation of the tube as shown. FLUSHING PUMP OFP-2...
  • Page 25 For saline fluid bag use, refer to Figure 3.5. Remove the cap from the spike of the MAJ-1682 Accessory Port Tube and fully insert the spike with a twist into the correct port of the saline bag. Hang the saline bag on an IV pole. FLUSHING PUMP OFP-2...
  • Page 26 Chapter 3 Preparation for use IV pole Saline bag Spike port Saline spike Figure 3.5 Manually rotate the roller in the pump head to align it centrally as shown in Figure 3.6 Pump roller Figure 3.6 FLUSHING PUMP OFP-2...
  • Page 27 • If the system fails to prime within 10 seconds, optimum flow rate may not be achieved. In this instance it is advised that the tubing be reloaded into the pump head. FLUSHING PUMP OFP-2...
  • Page 28 Chapter 3 Preparation for use Indicator line Indicator lines and flow direction arrows Pump Head arrows Tube grip Figure 3.7 FLUSHING PUMP OFP-2...
  • Page 29 Figure 3.9 Auxiliary channel connection (with MAJ-1608/MAJ-855): Refer to Figure 3.10 and connect the Luer lock connector on the MAJ-1608 water tube to the MAJ-855 auxiliary water tube attached to the auxiliary channel port on the endoscope. FLUSHING PUMP OFP-2...
  • Page 30 Figure 3.11 EndoTherapy accessory connection (with MAJ-1681 and MAJ-1682): (i) Press the power switch on the OFP-2 front panel. The flow rate indicators sequence up and down during startup and the standby switch and lowest setting flow rate indicator illuminates green to indicate the unit is in “ON”.
  • Page 31 Chapter 3 Preparation for use OFP-2 until all air bubbles have been expelled from the tubing. NOTE • In cold conditions, it may be necessary to prime the tubing at lower pump speed. • Priming is recommended between speed 5-9, depending on conditions.
  • Page 32 Figure 3.12 If using the optional MAJ-920 remote control cable, connect to the remote connector on the rear of the OFP-2 and the video system center. Refer to MAJ-920 instructions for setting endoscope remote switch functions and operating instructions. Taking care not to damage any cables, replace the rear panel on the workstation.

  • Page 33: Chapter 4 Operating Instructions

    5-9 until all air pockets are gone, then attach the EndoTherapy accessory. Press the power switch on the OFP-2 front panel. The flow rate indicators sequence up and down during startup and the standby switch and lowest setting flow rate indicator illuminates green to indicate the unit is in “ON”.
  • Page 34 Insert the endoscope into the patient after you have completed the necessary preparations in accordance with the endoscope manual. While using the OFP-2 on a patient, adjust the flow rate using the  and  flow rate controls on the front panel.
  • Page 35 • If there is no fluid flow during use, switch off the OFP-2 and depressurise the system by disconnecting the tube from the MAJ-855 auxiliary tube, MAJ-1606 instrument channel adapter or EndoTherapy device.
  • Page 36 To refill the water container while using it on a patient, press the standby switch to put the OFP-2 on standby, keep the pump head lever closed so the tube is not disturbed. Pull the tube from the water container cap and remove the container from the unit. Unscrew the cap, fill the container with the appropriate fluid then secure the cap.
  • Page 37 (iv) Open the pump head lever and remove the tube from the pump head. (v) Discard the tubing in an appropriate manner. If used, the water container and cap should be removed from the OFP-2 and cleaned and sterilized prior to reuse.

  • Page 38: Chapter 5 Cleaning And Sterilizing

    • The disinfection/sterilization room must be adequately ventilated. Adequate ventilation protects against the buildup of toxic chemical fumes. • Turn off the OFP-2 and disconnect the power cord prior to cleaning and servicing. CAUTION • Do not drop the water container or subject it to impacts. The container could become damaged and unusable.

  • Page 39: Cleaning And Sterilizing Summary Chart

    Automatic cleaning Manual cleaning. (Thermal) Refer to section 5.5 Refer to section 5.5 Steam sterilization. Refer to section 5.6 Store water container in accordance with national and local hospital guidelines and policies FLUSHING PUMP OFP-2...

  • Page 40: Compatible Reprocessing Methods And Chemical Agents

    Chapter 5 Cleaning and Sterilizing 5.3 Compatible reprocessing methods and chemical agents Compatibility summary Olympus endoscopic equipment is compatible with several methods of reprocessing. Certain components and accessories, however, are not compatible with some methods, which can cause equipment damage.

  • Page 41: Cleaning

    • For details on use of the detergent solution, refer to its instructions for use. NOTE Olympus recommends the use of a washer/disinfector which has been designed to meet EN ISO 15883-1 and 2 and/or to HTM 2030. Wear the protective equipment detailed in Section “Required cleaning and sterilizing equipment”...

  • Page 42: Steam Sterilization (Autoclaving)

    (if available) or by opening the door of the autoclave and allowing the packages to air-dry. Handling a wet package can compromise its sterility. • Always leave space between the packages in the autoclave. If packages are placed too close together, effective sterilization will not be possible. FLUSHING PUMP OFP-2...
  • Page 43 3 mins ANSI/AAMI ST79:2006 134 – 137C EN 285: 2006 HTM 2010:1994 CAUTION Do not exceed a maximum autoclave temperature of 137°C (279°F), nor an exposure time greater than 20 minutes, otherwise damage to the equipment may result. FLUSHING PUMP OFP-2...

  • Page 44: Chapter 6 Care And Storage

    Wipe the surface of the OFP-2 using a soft, lint-free cloth moistened with 70% ethyl or isopropyl alcohol to remove dust, dirt, etc.

  • Page 45: Storage

    Chapter 6 Care and Storage 6.2 Storage WARNING • Do not store the OFP-2 in a location exposed to direct sunlight, X-rays, radio activity or strong electromagnetic radiation (e.g. near microwave medical treatment equipment, short-wave medical treatment equipment, MRI equipment, radio or mobile phones). Damage to the OFP-2 may result.

  • Page 46: Chapter 7 Maintenance And Repair

    7.1 Routine Maintenance The following routine maintenance should be performed at the intervals specified: Hospital Engineer or Olympus - Annually: - Check that the power cable is in good condition. - Detach the pump head (Section “Pump Head Replacement” on page 46), and wipe the pump head thoroughly with a mild detergent solution.
  • Page 47 Align the pump drive shaft with the drive slot on the back of the pump head (Figure 7.3). Then rotate the pump head clockwise until it locks into an upright position. Mounting plate Bayonet Pump head Pump drive shaft Figure 7.2 FLUSHING PUMP OFP-2...

  • Page 48: Fuse Replacement

    Chapter 7 Maintenance and Repair Drive slot Figure 7.3 Turn the OFP-2 power supply ON and confirm that the control panel indicators illuminate and the standby LED then illuminates green. Press the footswitch and confirm that the pump runs. Lift the pump head lever and confirm that the standby LED turns to orange and the pump head does not rotate.

  • Page 49: Repair

    Plug in the power cord and turn the OFP-2 ON, confirm the power output. WARNING If the power fails to come on after replacing the fuses, unplug the power immediately from the mains power inlet and contact Olympus.

  • Page 50: Spares

    Chapter 8 Spares The Spares shown below are consumables. Please replace them in the event of their deterioration or failure. NOTE To maintain standards compliance, use only the following Spares with this product which are available from Olympus. Item P/no Footswitch 7501357 Fuse T2.5AH 250V (pack of 5)

  • Page 51: Chapter 9 Specification

    The endoscope is the applied part. The OFP-2 is an accessory to the applied part. Degree of None: the Olympus OFP-2 must NOT be used in the zone of risk of protection against flammable anaesthetic gases. explosion...
  • Page 52 Storage: 23.5–106 kPa Fluid ingress To IPX0. No protection. Resistance to The external surfaces of the Olympus OFP-2 are resistant to: 2% Aqueous Neutral chemicals Detergent, 70% Ethyl alcohol (J&J wipes), 70% Isopropyl Alcohol, Water, Anti-foaming agent, Saline Pump type...
  • Page 53 OLYMPUS video processor. Maximum pressure: Less than 1300 kPa Flow rate: variable, controlled from front panel. Flow rate delivery from the pump will depend on the length and type of OLYMPUS EVIS EXERA/EXERA II/LUCERA/EUS gastrointestinal/colono/ultrasound videoscope or EndoTherapy Accessory attached.

  • Page 54: Chapter 10 Troubleshooting

    20 seconds. Pump head lever has risen Replace with a new pump head. during pumping. Unit is in ‘standby mode’. Make sure the pump head lever is closed and the unit is placed in ‘run mode’. FLUSHING PUMP OFP-2...
  • Page 55 Check for kinked tube, or damaged pump flashes amber at a slow rate. overload and shut down. head or rollers (see above). To reset the All other functions are overload cutout, switch off the mains disabled. power then switch on again. FLUSHING PUMP OFP-2...
  • Page 56 Electrical - typically distortion/ Check system for damaged cables or interference on monitor display connectors. when equipment is operated. Electromagnetic - interference As above, plus investigate source of from other systems. interference. FLUSHING PUMP OFP-2...

  • Page 57: Chapter 11 Technical Description

    Chapter 11 Technical description Chapter 11 Technical description The OFP-2 incorporates a brushless d.c. motor to drive the peristaltic pump head, producing high output torque with quiet operation. The control software monitors position sensors built into the motor to generate the commutating signals, forming a closed-loop feedback circuit which ensures excellent speed control over a wide range of motor loadings.

  • Page 58: Electromagnetic Emissions

    Chapter 11 Technical description Olympus specified parts. WARNING • Use of this equipment adjacent to or stacked with non-Olympus equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

  • Page 59: Electromagnetic Immunity

    11.6 Accessories, transducers and cables WARNING Use of accessories, transducers and cables other than those specified in this document could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. FLUSHING PUMP OFP-2...

  • Page 60: Chapter 12 End Of Life

    Equipment which reached end of its useful life must be decontaminated to local regulations before disposal and disposed of according to local regulations. OFP-2 should be dismantled and disposed of in accordance with local, state, national or federal laws. Refer to “Specification” on page 51 for additional information.

  • Page 61: Appendix

    Appendix System chart The recommended combinations of equipment that can be used with the OFP-2 are shown overleaf. New products released after the introduction of the OFP-2 may also be compatible for use in combination with it. Contact your Olympus representative for further information on compatible products.
  • Page 62 Chapter 12 End of Life MAJ-1652 MAJ-1606 MAJ-855 MAJ-1607 MAJ-1651 MAJ-1608 MAJ-2209 MAJ-2210 MAJ-1682 MAJ-1681 MAJ-2207 MAJ-2208 MAJ-920 OFP-2 FLUSHING PUMP OFP-2...
  • Page 63 Compatible FKD knives (not for use in conjunction with MAJ-1606) Saline bag Compatible disposable bottles (*saline bottles only) MAJ-1603 2l water container Compatible video system center Compatible workstations and compact trollies Power cable Instructions for use Pneumatic bellow foot switch OPF-2 pump head FLUSHING PUMP OFP-2...
  • Page 64 438B, Alexandra Road, Alexandra Technopark Blk B, Fax: 6834-2438 Telephone: 6834-0010 #03-07/12, Singapore 119968 OLYMPUS (BEIJING) SALES & SERVICE CO,. LTD. A8F, Ping An International Financial Center, No. 1-3, Xinyuan South Road, Chaoyang District, Beijing, 100027 P.R.C. Fax: (86)10-5976-1299 Telephone: (86)10-5819-9000 OLYMPUS MOSCOW LIMITED LIABILITY COMPANY Elektrozavodskaya str.

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