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Olympus OFP-2, Инструкция по эксплуатации

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Important Information — Please Read Before Use

FLUSHING PUMP OFP-2

5

 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. 

The pump can also assist in the use of transendoscopic ultrasound probes by 

rapidly filling the organ to be examined.

Contraindications

 There are no known contraindications.

Patient target group

Not dedicated to any patient population.

Intended user

Medical use

Only for use by a qualified physician or a healthcare professional in an adequate 

medical environment. These instructions for use do not explain or discuss clinical 

procedures.

Reprocessing

Reprocessing of reusable products may only be performed by qualified hygiene 

personnel.

Repair

Repair of the product may only be performed by trained qualified servicing 

personnel that has been authorized by Olympus.  Otherwise, Olympus cannot be 

held responsible for the safety and performance of the product.

Содержание OFP-2

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

Страница 2: ......

Страница 3: ...Nomenclature and Functions 15 2 1 Front panel 15 2 2 Rear panel 16 2 3 Symbols and labels 16 Chapter 3 Preparation for use 21 Chapter 4 Operating instructions 33 Chapter 5 Cleaning and Sterilizing 38...

Страница 4: ...11 Technical description 57 11 1 EMC electromagnetic compatibility 57 11 2 Essential performance with regards to EMC 57 11 3 EMC environment 57 11 4 Electromagnetic emissions 58 11 5 Electromagnetic i...

Страница 5: ...c ultrasound probes by rapidly filling the organ to be examined Contraindications There are no known contraindications Patient target group Not dedicated to any patient population Intended user Medica...

Страница 6: ...nufacturer and or the relevant national authority according to national legislation Applicability of endoscopy and endoscopic treatment If there is an official standard on the applicability of endosco...

Страница 7: ...the Appendix to confirm that this instrument is compatible with the ancillary equipment being used Using incompatible equipment can result in patient injury and or equipment damage This instrument co...

Страница 8: ...mables used in conjunction with the OFP 2 The operator must assess the condition of the patient and use clinical judgement to set the flow rate from the pump to a suitable level to avoid patient traum...

Страница 9: ...utlet has adequate electrical capacity to power the equipment connected to it Failure to do so may cause fire or power failure to all equipment connected to the same power circuit To avoid risk of ele...

Страница 10: ...head lever when the OFP 2 is connected to an endoscope which is inserted into the patient Ensure the OFP 2 is positioned below patient level If any section of tube from the pump to the water container...

Страница 11: ...malfunction or failure In accordance with the instructions supplied with the endoscope ensure that the auxiliary water channel or instrument channel is free from blockages before starting a procedure...

Страница 12: ...to the EMC information provided in their accompanying documents It should be noted that portable and mobile RF communications equipment can affect medical electrical equipment The use of accessories a...

Страница 13: ...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 an...

Страница 14: ...on MAJ 1606 MAJ 1606 Instrument channel adaptor pack of 100 Instrument channel adaptor pack of 10 MAJ 1607 MAJ 1607 Instrument channel water tube pack of 50 Instrument channel water tube pack of 10 MA...

Страница 15: ...r when in standby mode The unit goes into standby mode when the pump head lever is open 3 Flow rate controls Increases or decreases the flow of water to the endoscope or the EndoTherapy device by pres...

Страница 16: ...head to be removed from the unit 8 Water container tray Supports the water container when fitted 9 Pump head lever Open and close when inserting or removing the tube in the pump head 2 2 Rear panel 1...

Страница 17: ...anufacture 21 8 digit serial number Symbol Description Source Catalog number ISO 15223 1 Serial number ISO 15223 1 Batch code ISO 15223 1 Date of manufacture ISO 15223 1 Manufacturer ISO 15223 1 Use b...

Страница 18: ...15223 1 Keep away from sunlight and heat ISO 15223 1 Keep dry ISO 15223 1 Stacking limit by number ISO 7000 This way up ISO 7000 In accordance with European Directive on Waste Electrical and Electroni...

Страница 19: ...control for changing over to remote control IEC 60878 Direction of flow Manufacturer PSE EMC Compliance METI PSE regulations Electrical Appliances and Materials Safety Act Japan Refer to instructions...

Страница 20: ...ling polypropylene ASTM D7611 13 This is a medical device according to MDR EU 2017 745 Manufacturer eIfU Instructions for use available online ISO 15223 1 Translation ISO 7000 Authorized representativ...

Страница 21: ...es If the workstation has a rear panel remove it NOTE Refer to the workstation instructions for rear panel removal replacement and manoeuvring details 3 Referring to Figure 3 1 place the OFP 2 on the...

Страница 22: ...revent fluid exuding from the cap Take care not to squeeze the filled water container when transferring back to the OFP 2 Take care when placing the filled water container into the OFP 2 tray Do not f...

Страница 23: ...a single day use item Check the model name shown on the sterile package and the tube and use them in accordance with their instruction manuals Failure to do so may pose an infection risk and or cause...

Страница 24: ...day use it may cause contamination Disinfection and sterilization are not available 4 MAJ 1681 Accessory Port Tube with Bottle Cap 2 48m After each patient use The tube and valve will become contamina...

Страница 25: ...and lens flushing actions until the bottle has been reset to its correct position and resume insufflation once any water has purged from Air Water valve 12 For saline fluid bag use refer to Figure 3 5...

Страница 26: ...reparation for use FLUSHING PUMP OFP 2 26 13 Manually rotate the roller in the pump head to align it centrally as shown in Figure 3 6 Figure 3 5 Figure 3 6 Saline spike Spike port IV pole Saline bag P...

Страница 27: ...that the tube is fully retained within the tube grips on the side of the pump head Figure 3 7c The tube should form a smooth radius when fitted Figure 3 7 CAUTION Be careful not to trap fingers when...

Страница 28: ...Chapter 3 Preparation for use FLUSHING PUMP OFP 2 28 Figure 3 7 a b c Indicator line Indicator lines and flow direction arrows Tube grip Pump Head arrows...

Страница 29: ...ttached to the instrument channel port on the endoscope 16 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...

Страница 30: ...tch 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...

Страница 31: ...J 1682 tubing must be primed with sterile saline in order to fully expel the air already in the tubing During this the tubing check valve may whistle until the air has been expelled This is correct op...

Страница 32: ...r of the OFP 2 and the video system center Refer to MAJ 920 instructions for setting endoscope remote switch functions and operating instructions 20 Taking care not to damage any cables replace the re...

Страница 33: ...hen attach the EndoTherapy accessory 1 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...

Страница 34: ...m level and increase it progressively until the appropriate level for the patient s condition has been identified 4 During the endoscopic procedure adjust the flow rate using the and flow rate control...

Страница 35: ...water container has been filled with sterile fluid and the fluid path is primed For EndoTherapy use ensure that the supply of saline does not run out during operation of the OFP 2 as harm may be caus...

Страница 36: ...with a new tube 8 After using it on a patient remove the endoscope from the patient If using this product to clean the endoscope s auxiliary channel please do so in accordance with the endoscope inst...

Страница 37: ...AJ 1606 instrument channel adaptor and the MAJ 1607 instrument channel tube in an appropriate manner 12 Remove the MAJ 1681 or MAJ 1682 accessory port tube as follows i Disconnect the tubing from the...

Страница 38: ...should be emptied cleaned and sterilized at least once per day Failure to do so could pose an infection control risk Failure to properly clean and sterilize the water container and caps could lead to...

Страница 39: ...reprocessing cycles whichever occurs sooner Discoloration can occur following reprocessing 5 2 Cleaning and sterilizing summary chart Inspect water container and cap for signs of damage Manual cleanin...

Страница 40: ...re is an infection risk when using insufficient detergents Alcohol is not a sterilant or high level disinfectant Required detergent solutions Use a medical grade low foaming neutral pH detergent or en...

Страница 41: ...water container Cleaning Steam Sterilization Autoclaving Protective equipment Appropriate personal protective equipment may include Eye wear face mask moisture resistant clothing and chemical resistan...

Страница 42: ...Dry thoroughly using clean lint free cloths 5 6 Steam Sterilization Autoclaving WARNING Remove the cap from the water container before sterilizing both of them Before taking the water bottle and cap a...

Страница 43: ...accordance with the steam sterilizer instruction manual or with the maker instructions 1 Before steam sterilizing the water container and cap must be thoroughly cleaned and dried Residual moisture in...

Страница 44: ...l socket and or the mains power inlet Cleaning them can deform or corrode the contacts causing damage to the OFP 2 Do not autoclave or gas sterilize the OFP 2 These methods will damage it Do not wipe...

Страница 45: ...equipment radio or mobile phones Damage to the OFP 2 may result The OFP 2 should be stored within the environmental conditions given in Specification on page 51 1 Turn the OFP 2 OFF and disconnect th...

Страница 46: ...pump head is a consumable Its performance will deteriorate as the number of usages increases The pump head may have deteriorated if the flow rate is low if the strength of water flow seems weak or if...

Страница 47: ...ure 7 2 and attach it to the mounting plate 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 po...

Страница 48: ...described in the above steps 3 to 6 are not observed immediately switch the unit s supply OFF disconnect the power cord and contact Olympus 7 4 Fuse Replacement WARNING The fuse must always be replace...

Страница 49: ...r immediately from the mains power inlet and contact Olympus CAUTION If the fuses continue to blow stop using the unit and contact Olympus or hospital engineer 7 5 Repair The OFP 2 must only be servic...

Страница 50: ...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 K10008954 Power cable UK 7145454 Power ca...

Страница 51: ...2003 the OFP 2 provides an adequate degree of protection against electrical shock as if it has an applied part isolated from all other parts of the equipment The endoscope is the applied part The OFP...

Страница 52: ...ing leads no power plug 3m long IEC 320 appliance connector Other cord sets may be available from local supplier Important The cores of the power cable supplied with this instrument are coloured in ac...

Страница 53: ...annel without an instrument inserted should be approx 785ml min when the pump head is new and its flow setting is 9 maximum The flow rate will reduce as the pump head deteriorates We recommend flow se...

Страница 54: ...as risen during pumping Replace with a new pump head Unit ON but no fluid flow Endoscope s auxiliary tube kinked or blocked Replace with a new auxiliary tube Footswitch tube is disconnected damaged or...

Страница 55: ...by indicator flashes amber at a slow rate All other functions are disabled Unit has sensed a motor overload and shut down Check for kinked tube or damaged pump head or rollers see above To reset the o...

Страница 56: ...to flow without user activation Internal fault has occurred Turn OFF the unit s power supply and remove the tube from the endoscope or EndoTherapy device Interference to other equipment in the vicini...

Страница 57: ...uble pole push switch on the front panel A Maintenance and Repair Manual is available from Olympus containing circuit diagrams parts lists descriptions replacement procedures and other information to...

Страница 58: ...pment could result NOTE The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals CISPR 11 class A If it is used in a residential environment for which...

Страница 59: ...Immunity IEC 60601 test level Electrostatic Discharge ESD IEC601000 4 2 2008 8 kV contact indirect 15 kV air Electrical fast transient burst IEC 61000 4 4 2012 2 kV for power supply lines 1 kV for in...

Страница 60: ...l 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 inf...

Страница 61: ...products WARNING If combinations of equipment are used other than those shown overleaf the full responsibility should be assumed by the medical treatment facility Such combinations do not only not al...

Страница 62: ...12 End of Life FLUSHING PUMP OFP 2 62 MAJ 1608 MAJ 1607 MAJ 1651 MAJ 855 MAJ 1606 MAJ 1652 OFP 2 MAJ 2209 MAJ 2210 MAJ 2207 MAJ 2208 MAJ 1681 MAJ 920 MAJ 1682 INS TR UC TIO NS FO R US E Work statio n...

Страница 63: ...s when used with auxiliary channel 3 Compatible FKD knives not for use in conjunction with MAJ 1606 4 Saline bag 5 Compatible disposable bottles saline bottles only 6 MAJ 1603 2l water container 7 Com...

Страница 64: ...OLYMPUS MEDICAL SYSTEMS CORP OLYMPUS MOSCOW LIMITED LIABILITY COMPANY OLYMPUS BEIJING SALES SERVICE CO LTD A8F Ping An International Financial Center No 1 3 Xinyuan South Road Chaoyang District Beijin...

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