OFP-2 FLUSHING PUMP and MAJ-1603 WATER CONTAINER Instructions Issue 13

Contents Important Information - Please Read Before Use...

5

Intended use...

5

Applicability of endoscopy and endoscopic treatment...

5

Instruction manual ...

6

Instrument compatibility...

6

Repair and modification...

6

Signal words...

6

Chapter 1

Checking the Package Contents...

10

1.1

Checking the OFP-2 package contents...

10

1.2

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

11

1.3

Consumables...

11

1.4

Accessories...

11

Chapter 2

Nomenclature and Functions...

12

2.1

Front panel...

12

2.2

Rear panel...

13

2.3

Symbols and labels...

14

Chapter 3

Preparation for use...

15

Chapter 4

Operating instructions...

25

Chapter 5

Cleaning and Sterilizing...

29

5.1

Importance of cleaning, disinfection, and sterilization...

29

5.2

Cleaning and sterilizing summary chart...

30

5.3

Compatible reprocessing methods and chemical agents . . .

31

5.4

Required cleaning and sterilizing equipment...

32

5.5

Cleaning...

33

5.6

Steam Sterilization (Autoclaving)...

34

Chapter 6

Care and Storage...

35

6.1

Care...

35

6.2

Storage...

36

Chapter 7

Maintenance and Repair...

37

7.1

Routine Maintenance...

37

7.2

Checking the Flow Rate...

37

7.3

Pump Head Replacement...

37

7.4

Fuse Replacement...

39

7.5

Repair...

40

FLUSHING PUMP OFP-2

1

2

Chapter 8

Spares...

41

Chapter 9

Specification...

42

Chapter 10

Troubleshooting...

45

Chapter 11

Technical description...

47

Chapter 12

End of Life...

48

Appendix

...

49

System chart ...

49

FLUSHING PUMP OFP-2

Important Information - Please Read Before Use

Important Information - Please Read Before Use Intended use The Olympus OFP-2 is a peristaltic flushing pump intended for use in medical facilities under the direction of a trained physician. The OFP-2 has been designed to be used with OLYMPUS gastrointestinal/colono/ultrasound endoscopes of EVIS EXERA/EXERA II/LUCERA/EUS series to facilitate washing of tissues to remove blood, faeces and other organic matter, enabling improved visualisation, diagnosis and therapy during endoscopic procedures. The pump will also allow water to be delivered into the GI tract to create a medium in which endoscopic ultrasound examinations can be performed. Do not use the equipment for any purpose other than its intended application.

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. 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.

FLUSHING PUMP OFP-2

5

Important Information - Please Read Before Use

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; edition2 (IEC60601-1-2: 2001). However, when connecting to an instrument that complies with the EMC standard for medical electrical equipment; edition1 (IEC60601-1-2: 1993), the whole system complies with edition1.

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 Chapter 10 ‘‘Troubleshooting’’ (page 45). If the problem cannot be resolved using the information in Chapter 10, 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. CAUTION

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.

NOTE Indicates additional helpful information.

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FLUSHING PUMP OFP-2

Important Information - Please Read Before Use

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. 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 Chapter 5. • For 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 auxiliary channel flushing, use only the MAJ-1608 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. • 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. • If high flow rates are required while accessory tools are inserted in the 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.

FLUSHING PUMP OFP-2

7

Important Information - Please Read Before Use

WARNING

• 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 and MAJ-1607 must be replaced after each patient use. 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 without authorization of the manufacturer. CAUTION

• Use only in conjunction with OLYMPUS gastrointestinal/colono/ ultrasound endoscopes of EVIS EXERA/EXERA II/LUCERA/EUS series. • 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 water tube from the pump to the water container is blocked or kinked, the flow rate will be noticeably reduced. Check the water tube for kinks or blockages, and should the slightest irregularity be suspected - do not use.

8

FLUSHING PUMP OFP-2

Important Information - Please Read Before Use

CAUTION

• If a kinked or damaged water tube causes the pump head to jam, the unit will sense the increased load on the motor and shut down. Refer to Chapter 10 ‘‘Troubleshooting’’ (page 45). • 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 water tube and clean and sterilize the water container and water container cap before the unit is reused. • 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. • Store and use the OFP-2 within the environmental conditions described in Chapter 9 ‘‘Specification’’ (page 42); failure to do so may lead to equipment malfunction or failure. • Only use replacement parts as specified in Chapter 8 ‘‘Spares’’ (page 41). 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.

FLUSHING PUMP OFP-2

9

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

10

Foot switch

FLUSHING PUMP OFP-2

Water container MAJ-1603

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 Consumables 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)

MAJ-1652**

Auxiliary channel adaptor (pack of 100)

*

In this manual the MAJ-1607 instrument channel water tube and the MAJ-1608 auxiliary channel water tube are collectively referred to as the water tube.

**

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 specify the product and quantity when purchasing.

1.4 Accessories Product

Description

MAJ-1603

Water container (pack of 3)

MAJ-855

Auxiliary water tube

MAJ-920

Remote control cable

FLUSHING PUMP OFP-2

11

Chapter 2 Nomenclature and Functions

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

2. Standby switch and indicator

OFP-2

3. Flow rate controls 9. Pump head lever

1. Power switch and indicator

5. Footswitch connection port

7. Pump head release lever

6. Pump head

8. Water container tray

Figure 2.1

12

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 “X” or decreases “W’’ the flow of water to the endoscope by pressing the X and W switches as required. The flow rate is stored in memory until the unit is switched OFF.

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.

FLUSHING PUMP OFP-2

Chapter 2 Nomenclature and Functions

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 water 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.

FLUSHING PUMP OFP-2

13

Chapter 2 Nomenclature and Functions

2.3 Symbols and labels

Standby switch Standby / Run

Remote connector

Mains power ON/OFF switch

Type BF applied part. The endoscope is the applied part. The OFP-2 is an accessory to the applied part.

Footswitch

Fuse

Pump head safety symbol



Direction of flow

Manufacturers symbol

5

This symbol on the water container indicates made from Polypropylene.

PP

Refer to instruction manual

This symbol on the product indicates it has been tested by Intertek Services Ltd.

This symbol on the product indicates conformity with appropriate EC directives.

EMC mark 100V

This product should be disposed of in accordance with local, state or federal laws.

Flow rate control

Caution

14

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 strerilize both items before use (see Chapter 5 Cleaning and Sterilizing (page 29)). WARNING

2.

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 Chapter 5.

Position the mobile workstation on a flat level surface and apply both castor brakes. 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 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

OFP-2 WM-NP1 shown

Figure 3.1 WARNING

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

4.

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

FLUSHING PUMP OFP-2

15

Chapter 3 Preparation for use

5.

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

• Only sterile water is to be used in conjunction with the OFP-2 during operation. This should be degassed if the OFP-2 is to be used with an ultrasound endoscope. Use of irrigation fluid other than sterile water may cause an infection risk to the patient. • The water container should always be removed from the OFP-2 and filled away from the workstation. • To prevent spillage, take care not to tilt the container too far when filled or when placing it on the water container tray. The water container will leak fluid from the hole in the cap when tilted beyond 15°. • To prevent 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 fill the water container past the “MAX” fill line.

6.

Insert the footswitch tube into the footswitch connection port on the front panel (Figure 3.2) and place the footswitch on the floor.

Figure 3.2 7.

16

Referring to Figure 3.3, open the pump head lever on the pump head to access the pump rollers.

FLUSHING PUMP OFP-2

Chapter 3 Preparation for use

Pump head lever

Pump head

Figure 3.3 8.

Confirm that the correct water tube will be used, noting the differences between the MAJ-1607 and MAJ-1608 given below. WARNING

The MAJ-1607 instrument channel water tube is a single-use disposable item. The MAJ-1608 auxiliary channel water tube is 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 equipment malfunction. Model Name

Exchange frequency

1. MAJ-1607 Instrument channel water tube (2.5m)

After each patient use

2. MAJ-1608 Auxiliary channel water tube (0.75m)

After one day use

FLUSHING PUMP OFP-2

Reason for exchange frequency The inside of the tube may be contaminated when exchanging the endoscope, it should be exchanged after each patient use. Disinfection and sterilization are not available. If the tube is not replaced after one day use, it may cause contamination. Disinfection and sterilization are not available.

17

Chapter 3 Preparation for use

Package view

MAJ-1607 MAJ-1608

Label side

Transparent side

Label side

1. MAJ-1607 Instrument channel water tube

Transparent side

2. MAJ-1608 Auxiliary channel water tube

External view MAJ-1607

2.5m

1. MAJ-1607 Instrument channel water tube

MAJ-1608

0.75m 2. MAJ-1608 Auxiliary channel water tube

18

FLUSHING PUMP OFP-2

Chapter 3 Preparation for use

9.

Referring to Figure 3.4, push the open end of the water tube (MAJ-1607/MAJ-1608) into the water container up to the indicator line noting the orientation of the tube as shown.

Indicator line

Open end

Connector

9

² Figure 3.4

10. Manually rotate the roller in the pump head to align it centrally as shown in Figure 3.5

Pump roller

Figure 3.5 FLUSHING PUMP OFP-2

19

Chapter 3 Preparation for use

11.

Insert the water tube into the pump head as follows. (i) Ensure that the flow direction indicated by the arrows on the water tube exactly correspond to that on the pump head. (ii) Hold the water tube on either side of the two remaining indicator lines and form a loop. Insert the formed loop fully into the pump head, taking care not to stretch the tube (Figure 3.6a). (iii) Release hold of the inserted tube and allow it to relax to a natural position within the pump head (Figure 3.6b). (iv) Close the pump head lever, ensuring that the tube is fully retained within the tube grips on the side of the pump head (Figure 3.6c). The water tube should form a smooth radius when fitted (Figure 3.7) NOTE • The water tube must not be stretched when closing the pump head lever as this may affect the ability of the system to prime, and may also reduce flow rate. • The water tube must not be pinched with the side of the pump head when closing the pump head lever as this may affect the ability of the system to prime, and may also reduce flow rate due to reduced inner diameter of tube. • 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.

20

FLUSHING PUMP OFP-2

Chapter 3 Preparation for use

Indicator line

a

Indicator lines

b

c

Tube grip

Figure 3.6

FLUSHING PUMP OFP-2

21