Torrent irrigation pump Reorder No Operating and Maintenance Manual

Transcription

1 Torrent irrigation pump Reorder No Operating and Maintenance Manual Rev. D

2 Issued Date: August 2018 Warning: An issued or revision date for these instructions is included for the user s information. In the event that two (2) years have elapsed between this date and product use, please contact US Endoscopy Customer Service at or your local US Endoscopy Product Specialist for a replacement to determine if additional information is available. Listening and delivering solutions, the US Endoscopy listening and delivering solutions design, and all marks denoted with or are registered with the U.S. Patent and Trademark Office, or trademarks owned by US Endoscopy US Endoscopy is a wholly owned subsidiary of STERIS Corporation US Endoscopy or affiliates. All rights reserved Rev. D

3 Table of Contents 1.0 Intended Use Features Warnings and Precautions Dangers and Warnings Precautions Notices Contraindications Explanation of Symbols Technical Specifications Environmental Requirements Inspection and Initial Set-Up Description of Controls Front Panel View Rear Panel View Use of the Torrent irrigation pump Pre-Procedural Set-Up Procedural Use Post-Procedural Shut Down Compatible Accessories Troubleshooting Guide Care and Cleaning Maintenance Routine Maintenance Electrical Safety Tests Installation of Replacement Parts Service and Repair Equipment Returns Information on Electromagnetic Compatibility (EMC) Rev. D

4 Rev. D

5 This product has been manufactured not to include latex. This product has been manufactured not to include DEHP, phthalates or BPA. 1.0 Intended Use The Torrent irrigation pump is intended for endoscopic irrigation for use with endoscope water jet channels and endoscope working channels. When used in conjunction with the Torrent irrigation pump, the Torrent irrigation system (tubing and accessories to accommodate various endoscopes) is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures. 2.0 Features The Torrent irrigation pump allows for the delivery of a variable pressurized lavage to improve visualization during endoscopic procedures. Footswitch controls allow for hands-free operation of the Torrent irrigation pump. The output flow rate of the Torrent irrigation pump is adjustable via a user accessible Flow Rate Control Knob. The Torrent irrigation pump is equipped with a safety feature which prevents the Pump Head from operating when the Pump Head Lid is open Rev. D Page 1 of 36

6 3.0 Warnings and Precautions The following Warnings and Precautions must be observed when operating or servicing the Torrent irrigation pump. For emphasis, certain warnings and precautions are repeated throughout this manual. It is important to review ALL warnings and precautions before operating or servicing the unit. Strictly following these warnings and precautions enhances your ability to safely and effectively use the unit and helps to avoid improper maintenance methods which may damage the unit or render it unsafe. It is important to understand that these warnings and precautions are not exhaustive; customers are encouraged to develop their own safety policies and procedures to enhance and complement these warnings and precautions. DANGER Indicates an imminently hazardous situation which, if not avoided, could result in death or serious injury. WARNING Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. CAUTION Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. NOTE Indicates a potentially hazardous situation which, if not avoided, may result in damage to property, or indicates an operating tip or general information useful for operating or servicing the equipment Rev. D Page 2 of 36

7 3.1 Dangers and Warnings 3.1A General Warnings WARNING: Endoscopic procedures should only be performed by persons having adequate training and familiarity with endoscopic techniques. WARNING: Consult the medical literature relative to complications, hazards and techniques prior to the performance of any endoscopic procedure. WARNING: A thorough understanding of the technical principles of endoscopic gastrointestinal irrigation is necessary before using the equipment and accessories. WARNING: The operator should assess the condition of the patient and use clinical judgment to set the irrigation flow rate to a suitable level to avoid patient injury. WARNING: Check the equipment and accessories each time before using them. The operator must not use damaged equipment or accessories as it may result in patient or operator injury or equipment damage or failure. If the equipment or accessories are damaged, please contact US Endoscopy Customer Service at or your local US Endoscopy Product Specialist for a repair or replacement. 3.1B Torrent irrigation pump Warnings DANGER: The Instructions for Use described in this manual MUST be followed; otherwise, compromised safety, unit malfunction, injury to the operator and/or patient, or costly damage to the unit and/or other equipment may occur. Read ALL sections of this manual carefully BEFORE using the Torrent irrigation pump, such that safety requirements and unit operation are understood. If you should have any questions, please contact US Endoscopy Customer Service at or your local US Endoscopy Product Specialist. DANGER: No modifications to this equipment are allowed. DANGER: This equipment is for use ONLY by trained, licensed medical professionals. Use of the Torrent irrigation pump without proper training can result in serious patient or operator injury or equipment damage. DANGER: Never install or operate the Torrent irrigation pump in an area where there is risk of flammable gases. There is a possible explosion hazard if used in the presence of flammable anesthetics or other flammable mixtures Rev. D Page 3 of 36

8 DANGER: Risk of electrical shock and other injuries to the patient and operator may occur because of improper electrical input parameters and accessories. Reference Section 6.0 Environmental Requirements for manufacturer specified input parameter requirements. The mains power supply voltage and frequency MUST match the input voltage and frequency specified on the rear panel of the equipment. The Torrent irrigation pump must be connected to a properly grounded power supply receptacle marked Hospital Grade or Hospital Only. Otherwise, grounding reliability cannot be achieved. DO NOT connect the Torrent irrigation pump to an extension cord, power strip or power supply adaptor. DANGER: Blown line fuses may ONLY be replaced by fuses which have the same rating as the one specified on the rear panel of the Torrent irrigation pump. Use of incorrect line fuses may result in malfunction or failure of the Torrent irrigation pump causing a fire or electric shock hazard. Line fuses may ONLY be replaced by qualified personnel with adequate training and knowledge. Reference Section 12.3B Fuse Replacement for instructions on replacing the fuses. Ensure the Fuse Holder has been fully installed into the Power Cord Receptacle following fuse replacement. Failure to do so may cause the Power Cord Receptacle to overheat. Prior to use after a line fuse has been replaced, functionality of the Torrent irrigation pump MUST be verified per the instructions in section 12.3B Fuse Replacement. If the unit does not function properly, DO NOT use the device, and please contact US Endoscopy Customer Service at or your local US Endoscopy Product Specialist for a repair or replacement. WARNING: This is a class A product. In a domestic environment, this equipment may cause radio interference in which case the operator may be required to take adequate measures. WARNING: Prior to use, inspect the Power Line Cord for damage. DO NOT use the Power Line Cord if it is kinked, crushed, worn, frayed or damaged in any way. DO NOT use or replace the Power Line Cord with a commercially rated line cord. If the Power Line Cord becomes worn, frayed, or damaged, replace it immediately with a Torrent irrigation Power Line Cord. To order a replacement Power Line Cord, please contact US Endoscopy Customer Service at or your local US Endoscopy Product Specialist for a replacement Rev. D Page 4 of 36

9 WARNING: Ensure the Torrent irrigation pump is powered OFF, denoted by the O on the Power ON/OFF Switch, when connecting to mains power supply. Failure to do so may result in equipment malfunction or damage. WARNING: Use proper aseptic techniques to avoid contamination of the Torrent irrigation tubing during device setup, replacement of water bottles, and between patient uses. WARNING: Exposure to bodily fluids may occur during the connection or disconnection of the Torrent irrigation tubing. The operator is responsible for adhering to Body Substance Isolation Protocols. WARNING: Pinch points are created when the Pump Head Lid is opened and closed. Watch hands and fingers when opening and closing the Pump Head Lid. Confirm that the Power ON/OFF Switch is in the OFF position (the O on the Power ON/OFF Switch should be pressed inward and the Power ON/OFF Switch should NOT be illuminated) before opening the Pump Head Lid to install or change Torrent irrigation tubing. WARNING: To reduce the risk of electrical shock, DO NOT attempt to clean the Torrent irrigation pump unless power is turned OFF. Ensure that the Power ON/OFF Switch is in the OFF position (the O on the Power ON/OFF Switch should be pressed inward and the Power ON/OFF Switch should NOT be illuminated) and the Power Line Cord is disconnected from the Power Cord Receptacle and mains power supply source BEFORE cleaning. WARNING: To safely remove mains power from the device, disconnect the Power Line Cord from the mains power supply. The Power Line Cord must remain accessible in case it becomes necessary to remove mains power from the Torrent irrigation pump. WARNING: A maintenance and safety inspection Torrent irrigation pump must be performed on an annual basis. Failure to perform this inspection may result in compromised safety, unit malfunction, injury to the operator and/or patient, or costly damage to the unit and/or other equipment. Reference Section 12.0 Maintenance for detailed maintenance instructions. WARNING: No parts of the Torrent irrigation pump can be serviced while it is in use on a patient. WARNING: To reduce the risk of electrical shock, DO NOT perform service other than as described in Section 12.0 Maintenance in this operating manual. Refer servicing to qualified and trained service personnel. The unit may ONLY be repaired by authorized and trained personnel. If your unit needs service or repair, please contact US Endoscopy Customer Service at or your local US Endoscopy Product Specialist. CAUTION: There are no operator serviceable parts within the housing of the Torrent irrigation pump Rev. D Page 5 of 36

10 WARNING: Flow should NEVER be directed into restricted orifices like the Ampulla of Vater or a Diverticulum. 3.2 Precautions 3.2A General Precautions CAUTION: Safety precautions must always be exercised when using electrical equipment to prevent operator/patient shock, fire hazard and equipment damage. CAUTION: Portable and mobile RF communications equipment may affect medical electrical equipment. Electromagnetic waves emitted by portable and mobile HF communication equipment may result in equipment failure or improper equipment performance. Reference Section 15.0 Information on Electromagnetic Compatibility (EMC) for recommended separation distances between portable and mobile HF communications equipment and the Torrent irrigation pump. CAUTION: Unsuitable transport or storage temperature and humidity may cause equipment damage or failure. Reference Section 6.0 Environmental Requirements for manufacturer recommended Transport and Storage parameters. If the equipment was transported or stored below or above the recommended temperature, pressure and humidity levels, the equipment will require a certain acclimation time at a specified temperature range. Insufficient acclimatization time or temperature may cause equipment damage or failure. Reference Section 6.0 Environmental Requirements for manufacturer recommended acclimatization parameters. CAUTION: Unsuitable operating temperature and humidity may cause equipment damage or failure. Reference Section 6.0 Environmental Requirements for manufacturer recommended Operating parameters. CAUTION: Install the device in such a way that there is an unobstructed circulation of air around the housing. If ventilation is unsuitable, the device can overheat and may cause equipment damage or failure Rev. D Page 6 of 36

11 CAUTION: Electrical equipment can affect the performance of other electrical equipment used in the vicinity by causing interference. Interference between the unit and other electrical equipment may not result in improper device performance or failure. Position the Power Line Cord as far away as possible from the cords of other electrical equipment. The instructions contained in the operating manuals of any equipment to be used in conjunction with the Torrent irrigation pump must be followed to avoid a possible hazard from incompatibility. The Torrent irrigation pump should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the equipment or system should be observed to verify normal operation in the configuration in which it is used. Are the devices behaving unusually? Do errors occur? 3.2B Torrent irrigation pump Precautions CAUTION: Place the Torrent irrigation pump on a stable, level surface or else the equipment may fall down or drop resulting in possible operator or patient injury or equipment damage. If a mobile cart is to be used, be certain that it provides adequate stability and strength to support the device and any other ancillary equipment. CAUTION: DO NOT place the sterile water bottle used with the Torrent irrigation pump where it can be exposed to heat emitted from ventilation ports of other equipment. Irrigation fluid may become hot over time resulting in patient burns. CAUTION: The Torrent irrigation pump should never be used in conjunction with other equipment for which safety against leakage current has not been established. CAUTION: DO NOT use the Torrent irrigation pump in an environment where it could be exposed to MRI systems. This device has not been tested for Magnetic Resonance compatibility. CAUTION: DO NOT use sharp or pointed objects to actuate the switches on the front and rear panel of the Torrent irrigation pump. CAUTION: Torrent irrigation pump should be positioned below the level of the patient. To prevent free-flow of irrigation fluid into the patient, DO NOT open the Pump Head Lid when the device is connected to an endoscope which is inserted into the patient. CAUTION: Replacement parts not listed in Section 12.3 Replacement Parts of this manual must NOT be used Rev. D Page 7 of 36

12 CAUTION: US Endoscopy did not design, perform compatibility for, nor does it intend for the Torrent irrigation pump to be used with any irrigation tubing other than Torrent irrigation tubing. Use of any other irrigation tubing with the Torrent irrigation pump may cause damage to the pump or the tubing and could affect Patient and Operator safety. See Section 9.4 Compatible Accessories for a list of all compatible accessories for use with the Torrent irrigation pump. For warnings, precautions and instructions for use specific to the Torrent irrigation system or other accessory items which are compatible with the Torrent irrigation pump, please refer to the Instructions for Use of the Torrent irrigation tubing, Torrent scope connector or another accessory item. CAUTION: Use only recommended cleaning/disinfecting agents on this unit. CAUTION: The Torrent irrigation pump housing is NOT water tight. If liquid penetrates the housing, the device may sustain damage or fail. Precaution must be taken when handling liquids around electrical equipment. DO NOT operate the Torrent irrigation pump if liquid has been spilled on the unit. DO NOT place sterile water bottle on top of the device. Utilize the provided Water Bottle Holder to secure the sterile water bottle in a safe location relative to the housing of the device in case of spills. DO NOT place the Torrent irrigation pump on top of other electrical equipment due to its fluid handling system. DO NOT SPRAY cleaning product directly onto the device or accessories. Dampen a soft cloth with the cleaning solution and wring out the excess moisture. Allow the cleaning solution to dry prior to reconnecting the Power Line Cord and connecting the device to a mains power supply source. CAUTION: This product contains materials which may require disposal through appropriately licensed and permitted hazardous waste management firms. There is a potential environmental hazard if waste electrical products are disposed of improperly. Follow your local regulations when disposing of electrical equipment Rev. D Page 8 of 36

13 3.3 Notices NOTE: The Torrent irrigation pump conforms to the requirements of Type CF and is protected against the effects of a defibrillator discharge. The Torrent irrigation pump is only protected against the effects of the pulse discharge of a defibrillator if appropriately rated cables are used. NOTE: If necessary, the Torrent irrigation pump can be connected to the external grounding system of the procedure room via the grounding pin on the rear panel of the unit using a connection cable designed for this purpose. 3.4 Contraindications Contraindications include those specific to any endoscopic procedure, use of peristaltic pumps and uncooperative patients Rev. D Page 9 of 36

14 4.0 Explanation of Symbols Use By Defibrillation-Proof Equipment Type CF Applied Part Contents Type and Rating of Fusing Reference Warning Dangerous Voltage Lot Warning Explosion Hazard Date of Manufacture Warning Pinch Point Hazard Non-Sterile General Warning Sign Authorized Representative in the European Community ON Power Discard within 24 hours after opening package OFF Power Equipotential Footswitch Follow Instructions for Use Non-ionizing Electromagnetic Radiation Alternating Current CE Mark Federal law (U.S.A.) restricts this device to sale, distribution, and use by or on the order of a physician. Rx Only (U.S.A.) The Torrent irrigation pump has been tested by TUV SÜD America, Inc. to electro-magnetic compatibility and safety standards. Do not use if packaging or product damage is evident. For sterile products only; contents are sterile if package is unopened and undamaged. This product should be recycled and not disposed of as general waste. In accordance with European Union WEEE Directive 2002/96/EC, US Endoscopy will be fully responsible for the coordination, logistics, and costs of the WEEE process Rev. D Page 10 of 36

15 5.0 Technical Specifications Electrical Rated Supply Voltage V~ ( 10%) / V~ ( 10%) Rated Supply Frequency Input Line Current 50 / 60Hz V~ nominal V~ nominal Input Fuse Rating Operating Mode 250 V T0.5 Amp Continuous Mechanical Flow Rate (Auxiliary Channel) * Flow Rate (Biopsy Channel) * Pressure Reservoir Pump Dimensions Height Width Depth Weight ml/min (with ) ml/min (with ) ml/min (with ) ml/min (with ) 80 PSI MAX (with ) 40 PSI MAX (with ) Compatible with most commercially available ml water bottles cm (7.1 inches) 16.6 cm (6.6 inches) 29.2 cm (11.5 inches) 2.9 kg (6.5 lbs.) Classification Type of Protection Against Electrical Shock: Class I per IEC / UL Degree of Protection Against Electrical Shock: Type CF Defibrillation Proof per IEC / UL Degree of Ingress Protection (IP Rating): IP22 Certifications IEC , IEC , IEC , IEC , CAN/CSA-C22.2 No * NOTE: Flow rate may vary depending on the endoscope model, endoscope channel diameter and channel length and the irrigation tubing set used. The flow rate values listed for the Torrent irrigation pump are based on the average flow rates obtained with several different manufacturer s GI endoscopes with ranging channel lengths and channel diameters Rev. D Page 11 of 36

16 6.0 Environmental Requirements Ambient conditions for transportation of unit: Temperature: Relative Humidity: Air Pressure: -30 C to +70 C / -22 F to +158 F 10% 95%, noncondensing hpa ( kpa) Ambient conditions for storage of unit: Temperature: Relative Humidity: Air Pressure: +15 C to +25 C / +59 F to +77 F 15% 80%, noncondensing hpa ( kpa) Ambient conditions for operation of unit: Temperature: Relative Humidity: Air Pressure: +15 C to +25 C / +59 F to +77 F 15% 80%, noncondensing hpa ( kpa) Acclimation If the unit has been stored or transported at temperatures below +15 C (+59 F) or above +25 C (+77 F), the unit will require approximately three (3) hours to acclimate at room temperature. DANGER: Never install or operate the Torrent irrigation pump in an area where there is risk of flammable gases. There is a possible explosion hazard if used in the presence of flammable anesthetics or other flammable mixtures. CAUTION: Portable and mobile RF communications equipment can affect medical electrical equipment. Electromagnetic waves emitted by portable and mobile HF communication equipment can result in equipment failure or improper equipment performance. CAUTION: Unsuitable transport storage or operating temperature and humidity may cause equipment damage or failure. CAUTION: Electrical equipment can affect the performance of other electrical equipment used in the vicinity by causing interference. Interference between the device and other electrical equipment may not result in improper device performance or failure. CAUTION: The Torrent irrigation pump should never be used in conjunction with other equipment for which safety against leakage current has not been established. CAUTION: Do not use the Torrent irrigation pump in an environment where it could be exposed to MRI systems. This device has not been tested for Magnetic Resonance compatibility Rev. D Page 12 of 36

17 7.0 Inspection and Initial Set-Up DANGER: The Instructions for Use described in this manual MUST be followed; otherwise, compromised safety, equipment malfunction, injury to the operator and/or patient, or costly damage to the unit and/or other equipment may occur. DANGER: Risk of electrical shock and other injuries to the patient and operator may occur because of improper electrical input parameters and accessories. Reference Section 6.0 Environmental Requirements for manufacturer specified input parameter requirements. The mains power supply voltage and frequency MUST match the input voltage and frequency specified on the rear panel of the equipment. The Torrent irrigation pump must be connected to a properly grounded power supply receptacle marked Hospital Grade or Hospital Only. Otherwise, grounding reliability cannot be achieved. DO NOT connect the Torrent irrigation pump to an extension cord, power strip or power supply adaptor. WARNING: DO NOT use or replace Power Line Cord with a commercially rated line cord. To order a replacement Power Line Cord, please contact US Endoscopy Customer Service at or your local US Endoscopy Product Specialist. CAUTION: Place the Torrent irrigation pump on a stable, level surface or else the equipment may fall down or drop resulting in possible operator or patient injury or equipment damage. If a mobile cart is to be used, be certain that it provides adequate stability and strength to support the device and any other ancillary equipment. 1. Prior to clinical use, familiarize yourself with the Torrent irrigation pump, Torrent irrigation tubing and endoscope connectors. 2. Be certain that all Warnings and Precautions have been read, understood and followed. 3. Unpack the Torrent irrigation pump and associated accessories from the packaging and confirm that all items are present and undamaged. If there is evidence of damage to the Torrent irrigation pump, Torrent irrigation tubing, or endoscope connectors, DO NOT USE them and please contact US Endoscopy Customer Service at or your local US Endoscopy Product Specialist for a repair or replacement. 4. The following items should be in the package: Torrent irrigation pump Torrent irrigation pump Operating and Maintenance Manual Power Line Cord Footswitch High Profile Water Bottle Holder 5. Review photos in Section 8.0 Description of Components in this manual Rev. D Page 13 of 36

18 6. The Torrent irrigation pump should be placed on a stable, horizontal surface. If a mobile cart is to be used, be certain that it provides adequate stability and strength to support the pump and any other ancillary equipment. 7. Prior to connecting the Power Line Cord to the unit and plugging it into the wall receptacle, be certain of the following: Ensure the temperature and humidity of the use location complies with the operating environment requirements as listed in Section 6.0 Environmental Requirements of this manual. Visually inspect the Power Line Cord that is used to provide power to the Torrent irrigation pump. If it is worn, frayed, or damaged, replace it immediately with a Torrent irrigation pump Power Line Cord. Ensure that the selected wall receptacle has a proper ground connection and complies with the input requirements as listed on the plate on the rear of the unit and Section 5.0 Technical Specifications in this manual. Ensure that the main power switch, the Power ON/OFF Switch, is in the OFF position (the O on the Power ON/OFF Switch should be pressed inward and the Power ON/OFF Switch should not be illuminated) when connecting the unit to the mains power supply. Visually inspect the Footswitch used to actuate the Pump Head. If the Footswitch or Footswitch Cord is worn, damaged or missing contact US Endoscopy Customer Service at or your local US Endoscopy Product Specialist to order a replacement Footswitch. Visually inspect the O-Ring on the Footswitch Connector which connects to the Footswitch Receptacle on the front panel of the unit. If it is worn, damaged or missing contact US Endoscopy Customer Service at or your local US Endoscopy Product Specialist to order a replacement Footswitch. Visually verify the presence of four (4) black, non-slip feet on the bottom of the unit. 8. Connect the proximal end of the Power Line Cord to the Power Cord Receptacle on the rear panel of the unit and plug the distal end into the compatible wall outlet. See Figure Insert the Footswitch Connector into the Footswitch Receptacle on the front panel of the unit; an audible click should be heard when the Footswitch Connector is attached. See Figure To disconnect the Footswitch Connector from the Footswitch Receptacle, depress the silver Quick Release Tab. See Figure Mount the Water Bottle Holder by sliding it into the bracket on the right side of the unit. See Figure To verify a positive connection between the mains power supply and the unit, turn the unit ON by pushing the Power ON/OFF Switch to the ON position (the I should be pressed inward). The Power ON/OFF Switch should become illuminated. 12. Push the Power ON/OFF Switch to the OFF position when not using the Torrent irrigation pump (the O should be pressed inward). The Power ON/OFF Switch should not be illuminated Rev. D Page 14 of 36

19 8.0 Description of Controls 8.1 Front Panel View Figure Flow Rate Control Knob: Flow rate can be increased by turning the Flow Rate Control Knob clockwise and decreased by turning the Flow Rate Control Knob counter-clockwise. 2. Power ON/OFF Switch: To turn the unit ON, press the I inward (switch will illuminate). To turn the unit OFF, press the O inward (illumination will go out) Footswitch: 4. Footswitch Connector: 5. Footswitch Receptacle with Quick Release Tab: A manual switch operated by pressure of the foot. Depress the Footswitch to activate water irrigation through the endoscope and into the Patient. Release the Footswitch to stop the flow of water. Reference section 9.4 Compatible Accessories for additional Footswitch options. White female CPC connector used to connect the Footswitch to the Footswitch Receptacle. Quick Release Tab accepts the snap-in Footswitch Connector. Depress the silver Quick Release Tab to disconnect the Footswitch Connector. 6. Pump Head: Pump Head contains three (3) rollers. When activated, the Pump Head provides irrigation fluid to the endoscope from the water bottle via peristaltic motion of the rollers. 7. Pump Head Lid: Manually open and close the Pump Head Lid to install and remove Torrent irrigation tubing. To OPEN, pull up on the Pump Head Lid. To CLOSE, lower the Pump Head Lid to its original position. 8. Water Bottle Holder: Used to secure the sterile water bottle to unit Rev. D Page 15 of 36

20 8.2 Rear Panel View Figure Fuse Holder: Holds two (2) replaceable T0.50A 250V fuses. 2. Power Cord Receptacle: Connector for Power Line Cord. 3. Power Line Cord: Hospital Grade power cord with grounded IEC-320 plug. 4. Equipotentiality (Grounding) Terminal: The unit can be connected to the external grounding system of the operating room with the grounding connector on the rear panel of the unit. Effects of low frequency leakage currents due to a defective grounding system within the operating room may be eliminated through external grounding. 5. Voltage Limit Switch: Allows for the adjustment of the internal power supply voltage limit. Slot fits flat head screw drivers. 115V for US market or similar voltage standards. 230V for European market or similar voltage standards Rev. D Page 16 of 36

21 9.0 Use of the Torrent irrigation pump WARNING: Check the equipment and accessories each time before using them. You must not use damaged equipment or accessories as it may result in Patient or Operator injury or equipment damage or failure. WARNING: Pinch points are created when the Pump Head Lid is opened and closed. Watch hands and fingers when opening and closing the Pump Head Lid. 9.1 Pre-Procedural Set-Up 1. Review Figure below. Lid Cap Sterile Water Bottle Water Bottle Tubing Roller Pump Tubing Endoscope Connector Positional Markers Figure Before each use of the Torrent irrigation pump, inspect the function and performance of the unit following the procedures in Section 7.0 Inspection and Initial Set-Up. If any irregularity, abnormality, or substandard performance is discovered, DO NOT USE THE UNIT; instead, refer to Section 10.0 Troubleshooting Guide of this manual. When in doubt, please contact US Endoscopy Customer Service at or your local US Endoscopy Product Specialist for a repair or replacement. 3. Open the bottle of sterile water and remove the cap. The Water Bottle Holder is compatible with most standard ml water bottles. 4. Open the Torrent irrigation tubing package and remove the device from the pouch. 5. Inspect the Torrent irrigation tubing to ensure there is no damage (holes, tears, etc.). 6. Attach the Lid Cap of the Torrent irrigation tubing to the bottle of sterile water. The Lid Cap will fit standard disposable sterile water bottles. See Section 9.4 Compatible Accessories for a list of compatible sterile water bottles Rev. D Page 17 of 36

22 7. Insert the Water Bottle Tubing section of the Torrent irrigation tubing into the sterile water bottle and firmly tighten the threaded Lid Cap to ensure the lid is secure. 8. Place the sterile water bottle into the Water Bottle Holder. 9. Open the Pump Head Lid of the Torrent irrigation pump. NOTE: The Torrent irrigation pump is equipped with a safety feature which prevents the Pump Head from operating when the Pump Head Lid is open. 10. Locate the Positional Markers on the flexible Roller Pump Tubing section of the Torrent irrigation tubing and insert the flexible Roller Pump Tubing section into the Pump Head between the Positional Markers. 11. While placing the Roller Pump Tubing section into the Pump Head, grasp the tubing together and gently pull upward. This will ensure that the flexible Roller Pump Tubing section is centered and aligned properly in the Pump Head to avoid kinking, tearing, or disruption of water flow. See Figures and below. Figure Figure Ensure the Torrent irrigation tubing is placed into the Pump Head in the direction of the arrow. Water flow is right to left when facing the pump. 13. Close the Pump Head Lid. Ensure the Roller Pump Tubing is not pinched by the Pump Head Lid. 14. Connect the Torrent irrigation tubing to either the accessory channel of the endoscope via a Bioshield irrigator or the endoscope auxiliary water port via an endoscope connector. 15. See IFU (Instructions for Use) for the Torrent irrigation tubing, Torrent scope connectors, Bioshield irrigators and reusable endoscope connectors listed in Section 9.4 Compatible Accessories Rev. D Page 18 of 36

23 16. Attach your preferred endoscope connector or Bioshield irrigator to the endoscope. 17. Attach the Torrent irrigation tubing to the preferred Endoscope Connector or Bioshield irrigator. 18. Push the Power ON/OFF Switch to the ON position (the I should be pressed inward). The Power ON/OFF Switch should become illuminated. 19. Prior to insertion of the endoscope into the patient, prime the Torrent irrigation tubing and the water irrigation channel/accessory channel of the endoscope prior by depressing the Footswitch. NOTE: Obtain a small container suitable to collect the output of sterile water from the priming action of the Torrent irrigation tubing. 19. Continue to depress the Footswitch for a few seconds with the flow rate set at the maximum setting. 20. After sterile water begins to flow from the distal end of the endoscope, adjust the Flow Rate Control Knob to obtain the desired flow rate. 21. Release the Footswitch to stop the flow of sterile water. Flow should stop quickly; residual flow may continue after release of the Footswitch for a few seconds. If water pressure is low, see section 10.0 Troubleshooting Guide, or please contact US Endoscopy Customer Service at or your local US Endoscopy Product Specialist for a repair or replacement Rev. D Page 19 of 36

24 9.2 Procedural Use WARNING: Flow should NEVER be directed into restricted orifices like the Ampulla of Vater or a Diverticulum. WARNING: The operator should assess the condition of the patient and use clinical judgement to set the irrigation flow rate to a suitable level to avoid patient injury. WARNING: Use proper aseptic techniques to avoid contamination of the Water Bottle Tubing during device setup, replacement of water bottles, and between patient uses. WARNING: Exposure to bodily fluids may occur during the connection or disconnection of the Torrent irrigation tubing. The operator is responsible for adhering to Body Substance Isolation protocols. 1. During endoscopic procedures, depress the Footswitch when lavage/irrigation is required. 2. Release the Footswitch when lavage/irrigation is not required. 3. If more irrigation fluid is required, increase the flow rate by rotating the Flow Control Knob on the front of the unit clockwise until desired flow is achieved. The flow rate should be set at the lowest setting and increased incrementally based on the clinical condition of the Patient. 4. To replace the sterile water bottle during use, leave the Pump Head closed with the tubing in place. Unscrew the Lid Cap and remove the Water Bottle Tubing from the empty sterile water bottle. Replace with new sterile water bottle. 4. After each procedure and when the endoscope has been removed from the patient, disconnect the Torrent irrigation system from the endoscope. NOTE: Ensure that the Torrent scope connector or the Bioshield irrigator is discarded after each use. The Torrent irrigation tubing can be used on multiple patients up to 24 hours. 5. Push the Power ON/OFF switch to the OFF position (the O should be pressed inward and the switch should not be illuminated) when pump is not in use. NOTE: If water pressure is low, see Section 10.0 Troubleshooting Guide, or please contact US Endoscopy Customer Service at or your local US Endoscopy Product Specialist for a repair or replacement Rev. D Page 20 of 36

25 9.3 Post-Procedural Shut Down After all procedures are completed for the day: 1. Push the Power ON/OFF switch to the OFF position (the O should be pressed inward and the switch should not be illuminated) before disconnecting the Torrent irrigation tubing. 2. Disconnect and discard the Torrent irrigation tubing from the Endoscope Connector at the end of the day or before 24 hours. 3. Disconnect and discard the Endoscope Connector (REF # / ) or the Bioshield irrigator (REF # / ) after each Patient use. 4. Reprocessible endoscope connectors (the Olympus MAJ-855, the Pentax irrigation tube OF- B113, and the Fujifilm JT-500 J Tube) can be reprocessed per the Manufacturer s reprocessing instructions. 5. See section 11.0 Care and Cleaning of this manual. Product Disposal: Handle and dispose of the product in accordance with accepted medical practice and applicable local, state and federal laws and regulations. This product should be recycled and not disposed of as general waste. In accordance with European Union WEEE Directive 2002/96/EC, US Endoscopy will be fully responsible for the coordination, logistics, and costs of the WEEE process. Follow your local regulations when disposing of electrical equipment Rev. D Page 21 of 36

26 9.4 Compatible Accessories Category/Type Product Product Number Disposable Torrent irrigation tubing with one-way valve Torrent irrigation tubing BX hour use Torrent irrigation tubing BX Disposable Torrent irrigation scope connector with oneway valves for water channel irrigation Single Patient use Reusable Endoscope Connectors Reprocess after each patient use Disposable Bioshield irrigators with one-way valve for accessory channel for irrigation Single use Torrent irrigation scope connector - Olympus Torrent irrigation scope connector - Pentax Olympus Auxiliary Water Tube MAJ-855 Pentax reusable irrigation tube OF-B113 Fujifilm reusable JT-500 J Tube Bioshield irrigator - Olympus Bioshield irrigator - Pentax BX BX See Olympus IFU for usage and reprocessing instructions. See Pentax IFU for usage and reprocessing instructions. See Fujifilm IFU for usage and reprocessing instructions. BX BX Sterile Water Bottles The Torrent TM irrigation pump is compatible with most commercially available ml water bottles. Footswitch - Low Profile - Single Footswitch High Profile Single EA (The low-profile footswitch is not packaged with the unit and is available by special order.) EA Water Bottle Holder EA Rev. D Page 22 of 36

27 10.0 Troubleshooting Guide Problem Possible Cause Action Power ON/OFF Switch is in the ON position (denoted by the I ); switch is NOT illuminated, but there is no power to the unit. No power from power supply. Power Line Cord not connected properly. Fuses in Fuse Holder blown. Check power source and verify the wall outlet is operational. Check Power Line Cord is fully connected to the Power Cord Receptacle on the rear panel of the unit. Switch the Power ON/OFF Switch to OFF. Unplug the Power Line Cord from the wall outlet and remove the Power Line Cord from the Power Cord Receptacle on the rear panel of the pump. Remove the Fuse Holder on the rear panel of the pump. Examine the fuses. If the wire within the fuse is damage or frayed or the glass is visibly discolored, replace with two (2) 250 Volt T0.5 Amp rated fuses. See Section 12.3B Fuse Replacement for detailed instruction. Power ON/OFF Switch is in the ON position (denoted by the I ); switch is illuminated, but there is no fluid flow. Internal problem. Flow setting is too low. Sterile water bottle is empty. Water Bottle Tube is not fully submerged into the sterile water. Roller Pump Tubing not installed into Pump Head properly. Torrent irrigation tubing is kinked, blocked or damaged. Endoscope Connector is blocked or damaged. Refer to qualified service personnel for repair. Contact US Endoscopy Customer Service at or contact your local US Endoscopy Product Specialist. Adjust flow setting by turning Flow Rate Control Knob on front panel clockwise until desired flow is reached. Replace sterile water bottle. Confirm that the Water Bottle Tube is fully submerged into the sterile water. Confirm the following: 1. The Roller Pump Tubing is inserted correctly into the Pump Head between the Positional Markers 2. The direction of flow is correct 3. The Pump Head Lid is properly latched. See Section 9.1 Pre-Procedural Set-Up for detailed instruction on proper irrigation tubing installation. Replace with new Torrent irrigation tubing set. Replace with new Endoscope Connector Rev. D Page 23 of 36

28 Problem Possible Cause Action Power ON/OFF Switch is in the ON position (denoted by the I ); switch is illuminated, but there is no fluid flow (continued). Footswitch is disconnected. Loss of Footswitch pressure. Endoscope is blocked or damaged. Check that the Footswitch is connected to the Footswitch Receptacle on the front panel of the unit. An audible click can be heard when the Footswitch Connector has been fully connected to the Footswitch Receptacle on the front panel of the pump. Disconnect and reconnect the Footswitch Connector to the Footswitch Receptacle on the front panel of the pump. Check endoscope and correct or replace per manufacturer s instructions. Power ON/OFF Switch is in the ON position (denoted by the I ); switch is illuminated, but fluid flow is poor. Footswitch Cord is damaged. Pump Head Lid or Pump Head are damaged. Pump Head is worn. Internal problem. Flow setting is too low. Voltage Limit Switch in the incorrect position. Roller Pump Tubing not installed into Pump Head properly. Torrent irrigation tubing is partially kinked, blocked, or damaged. Endoscope Connector is blocked or damaged. Replace with new Footswitch. Contact US Endoscopy Customer Service at or your local US Endoscopy Product Specialist for a replacement. Turn unit OFF, inspect Pump Head for damages. If damage is evident, refer to qualified service personnel for repair. Contact US Endoscopy Customer Service at or your local US Endoscopy Product Specialist. Replace with new Pump Head. Contact US Endoscopy Customer Service at or your local US Endoscopy Product Specialist. Refer to qualified service personnel for repair. Contact US Endoscopy Customer Service at or your local US Endoscopy Product Specialist. Adjust flow setting by turning Flow Rate Control Knob on front panel clockwise until desired flow is reached. Confirm that the Voltage Limit Switch on the rear panel of the unit is set to the appropriate voltage setting. See Section 8.2 Rear Panel View. Confirm the following: 1. Roller Pump Tubing is inserted correctly into the Pump Head between the Positional Markers. 2. The direction of flow is correct 3. The Pump Head Lid is properly latched, according to section 9.1 Pre-Procedural Set-Up. Replace with new Torrent irrigation tubing set. Replace with new Endoscope Connector Rev. D Page 24 of 36

29 Problem Possible Cause Action Power ON/OFF Switch is in the ON position (denoted by the I ); switch is illuminated, but fluid flow is poor (continued). Endoscope is partially blocked or damaged. Check endoscope and correct or replace per manufacturer s instructions. Power ON/OFF Switch is in the ON position (denoted by the I ); switch is illuminated, but fluid flow is poor (continued). Footswitch will not connect. Torrent irrigation pump shuts down during procedure. Pump Head is worn. Internal problem. Footswitch Receptacle latch is engaged. No power from power supply. Power Line Cord not connected properly. Internal problem. Replace with new Pump Head. Contact US Endoscopy Customer Service at or your local US Endoscopy Product Specialist. Refer to qualified service personnel for repair. Contact US Endoscopy Customer Service at or your local US Endoscopy Product Specialist. To disconnect the Footswitch Connector from the Footswitch Receptacle, press DOWN on the top of the silver Quick Release Tab to and it will spring into the OPEN position. Check power source and verify the wall outlet is operational. Check Power Line Cord is fully connected to the Power Cord Receptacle on the rear panel of the pump. Refer to qualified service personnel for repair. Contact US Endoscopy Customer Service at or your local US Endoscopy Product Specialist Rev. D Page 25 of 36

30 11.0 Care and Cleaning WARNING: Do not attempt to clean the Torrent irrigation pump unless power is turned OFF. Ensure that the ON/OFF Switch, is in the OFF position (the O on the ON/OFF Switch should be pressed inward and the ON/OFF Switch should not be illuminated) and the Power Line Cord is disconnected BEFORE cleaning. CAUTION: Use only recommended cleaning/disinfecting agents on this unit. CAUTION: DO NOT SPRAY any cleaning product directly onto the system components. Dampen a soft cloth with the cleaning solution and wring out the excess moisture. 1. Disconnect the Power Line Cord from the wall mains outlet, then disconnect the Footswitch Connector from the front of the unit by depressing the silver Quick Release Tab. Carefully coil the Footswitch Cord to avoid kinking. 2. The outer surfaces of the unit, the Footswitch and the Footswitch Cord may be lightly wiped with a soft cloth using water, a mild detergent or 70% isopropyl alcohol solution. NEVER use harsh or abrasive cleaning materials such as bleach. Always avoid the use of excessive moisture around electrical equipment. DO NOT sterilize the Torrent irrigation pump. 3. After cleaning the unit and accessories, allow all components to dry thoroughly before connecting to a power source. 4. Once cleaned, the Torrent irrigation pump and its accessories should be stored on a stable, horizontal surface in an area where it will be safe from impact or other accidental damage. The storage area should have temperature, humidity and pressure characteristics as described in section 6.0 Environmental Requirements of this manual and be free of any risk of water leaks, spills or splashes Rev. D Page 26 of 36

31 12.0 Maintenance WARNING: A maintenance and safety inspection of the Torrent irrigation pump must be performed on an annual basis. Failure to perform this inspection may result in compromised safety, unit malfunction, injury to the operator and/or patient, or costly damage to the unit and/or other equipment. WARNING: Do not use or replace Power Line Cord with a commercially rated line cord. If the Power Line Cord becomes worn, frayed, or damaged, replace it immediately with Torrent irrigation pump Power Line Cord Routine Maintenance Periodic inspection of the unit on an annual basis is recommended, or on a more frequent basis if conditions require. It is recommended that the following maintenance inspection be conducted annually: 1. Visually inspect the unit for external damage. 2. Visually inspect the Power Line Cord that is used to provide power to the Torrent irrigation pump. If it is worn, frayed, or damaged, replace it immediately with a US Endoscopy provided Power Line Cord. 3. Detach the Pump Head (see Section 12.3a Pump Head Replacement) and clean thoroughly with a mild detergent as described in Section 11.0 Care and Cleaning. Check the Pump Head rollers and Pump Head Lid for freedom of movement. 4. Verify that the Power ON/OFF Switch on the front panel of the Torrent irrigation pump is seated properly, undamaged, exhibits no evidence of fluid/dirt infiltration, and functions properly. Plug in the Power Line Cord and switch the Power ON/OFF Switch to the I position. Verify that the Power ON/OFF Switch is illuminated. 5. Visually inspect the Footswitch and Footswitch Cord used to actuate the Pump Head. If either is worn or damaged, Contact US Endoscopy Customer Service at or your local US Endoscopy Product Specialist to order a replacement Footswitch. 6. Visually inspect the O-Ring on the Footswitch Connector which connects to the Footswitch Receptacle on the front panel of the unit. If it is worn, damaged or missing contact US Endoscopy Customer Service at or your local US Endoscopy Product Specialist to order a replacement Footswitch. 7. Connect the Footswitch Connector to the Footswitch Receptacle. Close the Pump Head Lid and actuate the Footswitch and visually verify the Pump Head rotates counter-clockwise. Using the Flow Rate Control Knob, visually verify the speed of the Pump Head increases and decreases. 8. Open the Pump Head Lid. Actuate the Footswitch and visually verify that the Pump Head does NOT run Rev. D Page 27 of 36

32 12.2 Electrical Safety Tests The design of the Torrent irrigation pump is a solid-state circuit. It is recommended that a trained and qualified biomedical engineer do an electrical safety inspection at least annually. The electrical inspection must include at a minimum the following electrical tests: 1. Chassis Ground Integrity 2. Line Leakage Current 3. Insulation Resistance 4. HI Pot Testing 12.3 Installation of Replacement Parts 12.3A Pump Head Replacement Part Description Pump Head Torrent irrigation pump Product Number EA Switch the Power ON/OFF Switch to the OFF position (denoted by O on the switch) 2. Disconnect the Power Line Cord from the mains supply source and the rear panel of the unit. 3. Detach the Pump Head by depressing and holding the Pump Head Release Lever and then rotating the Pump Head 45 counter-clockwise (see Figure 12.3A.1). Pump Head Release Lever Figure 12.3A Rev. D Page 28 of 36