OFP-2 FLUSHING PUMP and MAJ-1603 WATER CONTAINER Instructions Issue 18

Contents Important Information - Please Read Before Use...

5

Intended purpose ...

5

Contact...

6

Applicability of endoscopy and endoscopic treatment ...

6

Instruction manual...

7

Instrument compatibility ...

7

Repair and modification ...

7

Signal words...

7

Warnings and cautions...

8

Chapter 1

Checking the Package Contents...

13

1.1

Checking the OFP-2 package contents...

13

1.2

Checking the MAJ-1603 package contents (if purchased separately)14

1.3

Consumable components...

14

1.4

Accessories...

15

Chapter 2

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

5.1

Importance of cleaning, disinfection, and sterilization...

38

5.2

Cleaning and sterilizing summary chart...

39

5.3

Compatible reprocessing methods and chemical agents . . .

40

5.4

Required cleaning and sterilizing equipment...

40

5.5

Cleaning...

41

5.6

Steam Sterilization (Autoclaving)...

42

Chapter 6

Care and Storage...

44

6.1

Care...

44

6.2

Storage...

45

Chapter 7

Maintenance and Repair...

46

7.1

Routine Maintenance...

46

7.2

Checking the Flow Rate...

46

7.3

Pump Head Replacement...

46

7.4

Fuse Replacement...

48

7.5

Repair...

49

FLUSHING PUMP OFP-2

1

2

Chapter 8

Spares...

50

Chapter 9

Specification...

51

Chapter 10

Troubleshooting...

54

Chapter 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 immunity...

59

11.6 Accessories, transducers and cables...

59

Chapter 12

End of Life...

60

Appendix

...

61

System chart ...

61

FLUSHING PUMP OFP-2

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. 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.

FLUSHING PUMP OFP-2

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Important Information - Please Read Before Use

Clinical benefits The clinical benefit of the device lies in its functionality as described by its intended purpose.

Contact Manufacturer KeyMed (Medical and Industrial Equipment) LTD KeyMed House, Stock Road, Southend-on-Sea, Essex SS2 5QH United Kingdom www.olympus.com [email protected]

Incident reporting  European Union If a serious incident occurs with the device, report it to the manufacturer and the relevant national authority.

 Eurasian Economic Union If a serious incident occurs with the device, report it to the manufacturer and the relevant national authority.

 Other regions If a serious incident occurs with the device, report it to the manufacturer 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 endoscopy and endoscopic treatment that is defined by the hospital’s administration or other official institutions such as academic societies on endoscopy, follow that standard. Before starting endoscopy and endoscopic treatment, thoroughly evaluate its properties, purposes, effects, and possible risks (their natures, extent and probability). Perform endoscopy and endoscopic treatment only when its potential benefits are greater than its risks. 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.

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FLUSHING PUMP OFP-2

Important Information - Please Read Before Use

Even after starting the endoscopy and endoscopic treatment, continue to evaluate the potential benefits and risks, and immediately stop the endoscopy/ treatment and take proper measures if the risks to the patient become greater than the potential benefits.

Instruction manual This instruction manual contains essential information on using this equipment safely and effectively. Before use, thoroughly review this manual and the manuals of all equipment which will be used during the procedure and use the equipment as instructed. 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” in 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 complies with the EMC standard for medical electrical equipment; IEC 60601-12:2014 Edition 4. However, when connecting to an instrument that complies with earlier editions of this standard, the whole system complies with that edition.

Repair and modification This equipment does not contain any internal user-serviceable parts. Do not disassemble, modify or attempt to repair it; patient or user injury and/or equipment damage can result. Some problems that appear to be malfunctions may be correctable by referring to “Troubleshooting” on page 54. If the problem cannot be resolved using the information in “Troubleshooting” on page 54, please contact Olympus.

Signal words The following signal words are used throughout this manual: WARNING

Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

FLUSHING PUMP OFP-2

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Important Information - Please Read Before Use

CAUTION

NOTE

Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices or potential equipment damage.

Indicates additional helpful information.

Warnings and cautions Follow the warnings and cautions given below when handling this equipment. This information is to be supplemented by the warnings and cautions given in each chapter. The OFP-2 is EMC-tested (electromagnetic compatibility) in conformity with the requirements of IEC 60601-1-2:2014 Edition 4 and meets the general electrical safety requirements of IEC 60601-1:2005 + A1:2012 Edition 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. • For additional information, refer to the appropriate ‘instructions for use’ for the equipment and consumables 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 trauma. The flow rate should always be checked at the start of the procedure and be increased/decreased progressively to a level commensurate with the clinical condition of the patient and degree of washing required.  Note that this unit can deliver flow rates through the instrument

channel of the endoscope in excess of that which can be delivered when using a 50ml syringe.

• The water container and cap were not cleaned, disinfected, or sterilized before shipment. Before using the water container and the cap for the first time, reprocess these according to “Operating instructions” on page 33. • For endoscope instrument channel flushing, use only the MAJ-1607 instrument channel water tube with MAJ-1606 instrument channel adaptor, otherwise patient safety may be compromised or damage to the pump may occur. • For endoscope auxiliary channel flushing, use the MAJ-1608 or MAJ1651/2 auxiliary channel water tube with MAJ-855 auxiliary water tube to connect the OFP-2 to the endoscope, otherwise patient safety may be compromised or damage to the pump may occur.

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FLUSHING PUMP OFP-2

Important Information - Please Read Before Use

• For EndoTherapy accessory channel flushing, use the MAJ-1681 or MAJ-1682 accesssory port tubes, otherwise patient safety may be compromised or damage to the pump may occur. • When flushing with ø2.0 to ø2.2mm instrument channel videoscopes, remove the EndoTherapy instrument from the MAJ-1606. Otherwise, leakage or spraying of potentially contaminated fluid may occur. With an EndoTherapy instrument inserted in the instrument channel, do not flush and extract at the same time, as there is a potential risk of spraying. WARNING

• If high flow rates are required while accessory tools are inserted in the endoscope instrument channel, there is an increased risk of fluid leakage. Therefore, the user should slow the pump speed to reduce any fluid loss, or take precautionary measures to ensuring there is no danger to users, patients or equipment. • Note that the luer lock connector on the MAJ-855 includes a one-way valve to prevent backflow - do NOT use the MAJ-855 without this connector in place, or water tube, water container and water contamination may result. • Confirm that the wall power outlet 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 electric shock, this equipment must only be connected to a supply mains with protective earth. • The water tube MAJ-1608 must be replaced daily - failure to do so may lead to patient infection and a reduction in equipment performance. • When removing the MAJ-855 from the MAJ-1608, firstly ensure the pinch clamp is always closed to prevent fluid leakage when disconnection is made, to avoid a slip hazard. • Clean, disinfect or sterilize the MAJ-855 following each use according to the manufacturer’s instructions supplied with the product and instructions of the endoscope. • The MAJ-1606, MAJ-1607, MAJ-1652, MAJ-1681 and MAJ-1682 are single use, disposable items, and must be replaced after each patient. Do not reuse or attempt to resterilize them. Failure to do so may lead to risk of cross-infection. • 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. • The operator should not touch the Remote Control socket whilst simultaneously touching the patient. • Do not modify this equipment.

FLUSHING PUMP OFP-2

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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” on page 33 of this document. • Always use the supplied power cord. Use of any other power cord can cause a malfunction of the device or the power cord to burn. Additionally, the supplied power cord is for exclusive use with the device it has been provided with and must not be used with other devices. CAUTION

• Do not use sterile accessories if the packaging is damaged or opened. • Use only in conjunction with OLYMPUS gastrointestinal/colono/ ultrasound endoscopes of EVIS EXERA/EXERA II/EXERA III/LUCERA/ LUCERA ELITE/EUS series and compatible EndoTherapy instruments.

CAUTION

• Check the “USE BY” date of all accessories as indicated on the packaging label. Do not use any accessories beyond the specified “USE BY” date. • Do not allow the water container to run dry, otherwise air will be supplied to the patient causing discomfort. • To prevent free-flow of water to the patient, do not open the pump 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 is blocked or kinked, the flow rate will be noticeably reduced. Check the tube for kinks or blockages, and should the slightest irregularity be suspected do not use. • If a kinked or damaged tube causes the pump head to jam, the unit will sense the increased load on the motor and shut down. Refer to “Operating instructions” on page 33. • Should the OFP-2 be operated with a blocked endoscope or MAJ-1608 with its tube pinch clamp closed, damage to the endoscope and/or water tube may occur. In this event, care must be taken when disconnecting the fluid path as the system may be pressurised. To assist in depressurising the system, the pump head should be opened to allow water back into the bottle. This must only be carried out with the endoscope removed from the patient. • In the event of tube pinch clamp failure when using MAJ-1608, drain the fluid back to the source by opening the pump head and lifting the connector end above the water level in the fluid container/ bottle before disconnection. The tube and clamp should be replaced if any fault is detected. • Replace the tube and clean and sterilize the water container and water container cap before the unit is reused.

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FLUSHING PUMP OFP-2

Important Information - Please Read Before Use

• Inspect the MAJ-855 for obvious signs of wear or damage, and should the slightest irregularity be suspected - do not use. Replace in accordance with its instructions for use. • Before each use, inspect the water container and cap for obvious signs of wear or damage and should the slightest irregularity be suspected do not use. • Always remove and empty the water container before moving the equipment. Care should be taken to obtain a firm grip underneath the body of equipment before moving. The water container must never be used as a hand hold or carrying handle. • Do not remove the water container while the pump is active. Ensure that the pump is in the ‘OFF‘ position before removing or replacing the tube sets. • Store and use the OFP-2 within the environmental conditions described in “Specification” on page 51; failure to do so may lead to equipment malfunction or failure. CAUTION

Only use replacement parts as specified in “Spares” on page 50. Failure to do so may lead to equipment 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. • Personal protective equipment should be used in accordance with local or national clinical guidelines. • 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 directly exposed to heat emitted from adjacent equipment, otherwise fluid in the container may become hot after a period of time and scald the patient. • Before the procedure begins when using the MAJ-1681, ensure the water container is filled with sterile saline. • Activation of the pump while the tubing/EndoTherapy accessory is connected to the OFP-2 but not inserted into an endoscope may result in potentially contaminated fluid being pumped from the end of the system and coming into contact with the floor, electrical equipment and people in the area. • If a water tube is installed incorrectly and becomes damaged, the water tube set must be discarded and replaced.

FLUSHING PUMP OFP-2

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Important Information - Please Read Before Use

• Prior to each use, ensure the tube connections are secure, watertight and routed to eliminate potential flow restrictions caused by, but not limited to, tube kinking or accidental tube compression. Keep the tubing clear of the patient at all times. In the event of entanglement, stop the procedure and re-route the tubing. • Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according 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 and cables other than those specified may result in increased emissions or decreased immunity of the medical electrical equipment or system. • 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. • When the OFP-2 is used in close proximity to other equipment, the medical electrical equipment or system should be observed to verify normal operation in the configuration in which it will be used.

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FLUSHING PUMP OFP-2

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.

Instruction manual

Olympus Flushing Pump OFP-2

Power cord

Foot switch

FLUSHING PUMP OFP-2

Water container MAJ-1603

13

Chapter 1 Checking the Package Contents

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.

Water container MAJ-1603 (3 pcs)

Instruction manual

1.3 Consumable components Product

Description

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)

MAJ-1608 MAJ-1608

Auxiliary channel water tube (pack of 50) Auxiliary channel water tube (pack of 10)

MAJ-1651*

Auxiliary channel water tube set (pack of 10) supplied sterile

MAJ-1652*

Auxiliary channel adaptor (pack of 100) supplied sterile

MAJ-1681

Accessory port tube with bottle cap (pack of 10) supplied sterile

MAJ-1682

Accessory port tube with saline spike (pack of 10) supplied sterile

MAJ-2207**

Irrigation Tubing with CO2 (pack of 10) supplied sterile

MAJ-2208**

Irrigation Tubing with CO2 (pack of 10) supplied sterile

MAJ-2209**

Irrigation Tubing with Air (pack of 10) supplied sterile

MAJ-2210**

Irrigation Tubing with Air (pack of 10) supplied sterile

* The MAJ-1651/1652 is an alternative to the MAJ-1608 and MAJ-855 and is supplied sterile. Please refer to the MAJ-1651/1652 instructions for use for installation. ** Please refer to MAJ-2207/2208/2209/2210 instructions for use for installation. Please specify the product and quantity when purchasing.

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FLUSHING PUMP OFP-2

Chapter 2 Nomenclature and Functions

1.4 Accessories Product

Description

MAJ-1603

Water container (pack of 3)

MAJ-855

Auxiliary water tube

MAJ-920

Remote control cable

Chapter 2 Nomenclature and Functions 2.1 Front panel 4. Flow rate indicators

2. Standby switch and indicator

OFP-2

9. Pump head lever

1. Power switch and indicator

5. Footswitch connection port

3. Flow rate controls

7. Pump head release lever

6. Pump head

8. Water container tray

Figure 2.1 1.

Power switch and indicator This switch is pressed to turn the power ON or OFF. The power indictor will illuminate green when power is ON.

2.

Standby switch and indicator The standby switch changes the unit from “standby mode” to “run mode”. The standby indicator illuminates green when the unit is in “run mode” and amber 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 pressing the  and  switches as required. The flow rate is stored in memory until the unit is switched OFF.

FLUSHING PUMP OFP-2

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Chapter 2 Nomenclature and Functions

4.

Flow rate indicators Displays the current flow rate setting.

5.

Footswitch connection port Allows connection of the footswitch to control pump operation.

6.

Pump head The rotary type peristaltic pump comprises three rollers which transfers water from the water container to the endoscope or the EndoTherapy device.

7.

Pump head release lever Allows the pump 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. Remote control socket

2. Mains power inlet

Figure 2.2 1.

Remote control socket Enables the OFP-2 to be remotely controlled from other compatible Olympus equipment via the MAJ-920 remote control cable.

2.

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 UDI label UNIQUE DEVICE IDENTIFICATION

16

FLUSHING PUMP OFP-2

Chapter 2 Nomenclature and Functions

A label required by some countries’ regulations regarding identification of medical device also known as Unique Device Identification. The following information is being coded in the 2-dimensional barcode (GS1 Data Matrix); (01) 14-digit GS1 Global Trade Item number. (11) 6-digit date of manufacture. (21) 8-digit serial number. (01) 00000000000000 (11) 000000 (21) 00000000

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-by date

ISO 15223-1

Federal (USA) law restricts this device to sale by or on the order of a physician

FDA

CE marking indicating that the device is in conformity with the applicable requirements set out in applicable European Union harmonization legislation

MDR (EU) 2017/745

Temperature limit

ISO 15223-1

FLUSHING PUMP OFP-2

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Chapter 2 Nomenclature and Functions

Humidity limit

ISO 15223-1

Atmospheric pressure limit

ISO 15223-1

General warning sign

ISO 7010_W001

Caution, consult accompanying documents

ISO 7000

Fragile, handle with care

ISO 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 Electronic Equipment (WEEE), this symbol indicates that the product must not be disposed of as unsorted municipal waste, but should be collected separately

18

European Directive 2002/96/EC

Stand-by

IEC 60417-5009

Mains power ON/OFF switch

IEC 60417-5010

FLUSHING PUMP OFP-2

Chapter 2 Nomenclature and Functions



ETL CLASSIFIED

Foot switch

IEC 60417-5114

Alternating current

IEC 60417

Fuse

IEC 60878

Risk of trapping hand/finger

Manufacturer

To indicate the 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 for use

ISO 7010-M002

Consult instructions for use

ISO 15223-1

Indicates the unit has been independently assessed for compliance with AAMI ES60601-1 and CSA standards

EN 60601

FLUSHING PUMP OFP-2

19

Chapter 2 Nomenclature and Functions

Medical Device

olympus-europa.com

0086

20

Unit complies with China RoHS 2 requirements

China RoHS 2 – Management methods for the Restriction of the Use of Hazardous Substances in Electrical and Electronic Products, January 2016

Recycling polypropylene

ASTM D761113

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 representative in the European Community / European Union

ISO 15223-1

UKCA Marking indicating that the device is in conformity with the applicable requirements set out in the applicable UK legislation.

MHRA

Importer

ISO 7000

FLUSHING PUMP OFP-2

Chapter 3 Preparation for use

Chapter 3 Preparation for use 1.

Unscrew the cap from the water container and clean and sterilize both items before use (see “Cleaning and Sterilizing” on page 38). WARNING

2.

Position the mobile workstation on a flat level surface and apply both castor brakes. If the workstation has a rear panel, remove it. NOTE

3.

The water container and cap were not cleaned, disinfected, or sterilized before shipment. Before using the water container and the cap for the first time, reprocess these according to “Cleaning and Sterilizing” on page 38.

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.

KV-5 or KV-6

OFP-2 WM-NP2 shown

Figure 3.1 WARNING

The OFP-2 should only be used in conjunction with a KV-5/KV-6 or other suitable sources of medical suction as specified in the endoscope instruction manual.

4.

Fill the water container up to the max fill line with sterile fluid (deaerated water when using with ultrasound products) and secure the cap.

5.

Place the water container into position on the OFP-2.

FLUSHING PUMP OFP-2

21