Pure Processing FlexiPump User Manual

FlexiPump™ Independent Flushing

System User Manual

Pure Processing, LLC 470 Mission Street, Unit 2 Carol Stream, Illinois 60188

www.pure-processing.com Support: 877-718-6868 Manual FPIFS 0001/April 2015

2

TABLE OF CONTENTS

Page(s)

3 3 4 4 5 5 6 6 7 8 9 9 10

10

11

12

13

14

15

16

Section

OVERVIEW: FlexiPump™ Independent Flushing System

SYSTEM DESCRIPTION

OPERATION: Set-up with Nest Accessory

OPERATION: Set-up with Sink Rail Accessory

OPERATION: Set-up on a wall

OPERATION: Set-up on PureStation™ Sink Insert

OPERATION: Set-up tube sets

OPERATION: General guidelines for speed control

OPERATION: Connecting devices to the FlexiPump system

OPERATION: Connecting flexible endoscopes to the FlexiPump system

OPERATION: PSI Settings

OPERATION: General rules and guidelines for flexible endoscope speed

control OPERATION: FlexiPump Cycles

OPERATION: Keypad Operation

MAINTENANCE: Decontaminating the tube set

MAINTENANCE: Cleaning FlexiPump Surfaces

MAINTENANCE: Replacing the Tube Set

MAINTENANCE: Instructions for replacing the Tube Set

TROUBLESHOOTING

REPLACEMENT PARTS

REPLACEMENT ADAPTERS

ADDITIONAL ACCESSORIES

DAILY ASSURANCE LOG

17

3

OVERVIEW: FlexiPump™ Independent Flushing System

The FlexiPump system is designed for use in a medical reprocessing area. It is engineered to provide optimal flushing capacity, installation flexibility, and easy use and maintenance. It can be used independently or with a Pure Station™ Sink Insert, and has been fully tested for use with a wide variety of reusable lumened devices, including rigid and flexible endoscopes, minimally invasive surgical devices, ocular and robotic devices, and suction tips.

The FlexiPump System is adaptable for counter, sink or wall installation near a water source. Accessories are available from Pure Processing to adapt the system to multiple additional uses. The FlexiPump tube sets connect to most devices, with or without luer locks and/or ports. A pressure relief feature is included to help protect scopes during flushing. The FlexiPump system can be used alone or can augment existing pumps. Up to three devices can be flushed at once through each FlexiPump unit.

DESCRIPTION

Components

 Removable cap with side tabs  Pump housing  Electric cord

Key Pad

 Impact Cycle button  Stop Cycle button  Forward Flush button  Speed Control button

Internal Components

 Squeeze tube  Rotor  Supply tube (connects to medical devices)

4

OPERATION

Set-up: new FlexiPump Independent Flushing System

Your FlexiPump system does not come with a tube set installed. To install your first tube set, please see the Maintenance section in this manual (page 12).

Set-up: with Nest Accessory

The Nest Accessory can be set up on any counter near a sink. Simply insert the FlexiPump system into the Nest with tubes facing the labeled front of the accessory. Plug the power supply cord into an electrical outlet.

NOTE: Do not place pumps directly under a water supply.

Set-up: with Sink Rail Accessory

The Sink Rail accessory (sold separately) adheres to the top inside surface of a clean sink at the top edge. Once the rail is attached, lock the back of the FlexiPump system onto the Sink Rail track, then plug the FlexiPump power supply cord

a wall outlet.

into

Use extra caution with sink wall installations to avoid impact with hard surfaces.

5

OPERATION (continued)

Set-up: on a wall

The Nest Accessory can be mounted on a wall using the two through-holes in the back of the accessory. Simply hang the nest on a wall near a sink and insert the FlexiPump unit. Then plug the cord into an outlet. (Hardware not included.)

Mounting holes

Set-up: on Pure Station™ Medical Devices Pre-Cleaning System

The FlexiPump system can be inserted into the corner well of the PureStation Sink Insert, or along the side ridges molded into the sink.

The FlexiPump unit is not meant to be submerged; use caution when installing near water.

6

OPERATION (continued)

Set-up: tube sets

The drop-down tube on each new tube set is 30 inches long. If the tube is too long for your sink, it can be cut to shorten it. If you cannot position it so it is submerged under the cleaning solution, use a tissue clip or other medical device to add weight and rest it at the bottom of the sink where solution is drawn from. A ceramic weight can also be purchased from Pure Processing.

Each FlexiPump tube set comes with three (3) leads, each of which can be attached to an instrument. You can use all three at once. If you have fewer than three devices to flush, you can cap off the unused lead(s) to ensure appropriate pressure into the lead(s) with attached devices. Use the luer end cap provided with your tube set. You may also re-use end caps from other FlexiPump tube sets.

General guidelines for speed control

Because fluid will take the path of least resistance, it is important that instrument channels attached to a FlexiPump system are approximately the same diameter, to assure consistent flushing into all the devices. DO NOT ATTACH A LARGE-DIAMETER LUMEN TO ONE LEAD AND A SMALL-DIAMETER LUMEN TO ANOTHER ON THE SAME PUMP SYSTEM.

 Low speed: this setting is designed for small channels, 1 to 3 millimeters (mm) in size. This setting

will flush 500 milliliters (ml) of fluid in one minute into all three channels (166 ml through each lead). DO NOT TURN UP THE SPEED when you hear the motor slowing down. The smaller channels cannot accommodate any higher flow volume. Trying to force it to go faster will cause back up in the motor and will make the pressure release valve drain fluid.

 Medium speed: This setting is designed for channels that are 2 to 3 mm in diameter. This setting

will flush 750 ml of fluid in one minute into all three channels (250 ml through each lead). DO NOT TURN UP THE SPEED if you hear the motor slowing down. However, if there is fluid draining from the pressure relief valve, you can consider slowing the pump speed.

 High Speed: This setting will flush 1,000 ml of fluid in one minute into all three channels (333 ml

through each lead). This is used for channels larger than 4 mm in diameter.

Too much pressure and speed for small devices can result in tube set damage.

7

OPERATION (continued)

For devices with luer locks:

For devices with ports:

 Pull the tube collar back  Insert the slip tip into the device  Flush according to manufacturer’s

recommendations

For devices without luer locks or ports:

 Use a cup adaptor to create a tight seal  Flush according to manufacturer’s

recommendations

For devices with female luer locks:

 Use a female-to-female luer lock adapter  Flush according to manufacturer’s

recommendations

Connecting devices to the FlexiPump system

Many lumened/channeled devices can be properly connected and flushed with the FlexiPump system.

 Twist the FlexiPump tube collar onto the device

with a luer, until locked

 Flush the device following manufacturer’s

recommendations

8

OPERATION (continued)

The injector tube (or suction channel tube in this example) is used to inject reprocessing fluids into the instrument channel, suction channel, and air/water channels of the endoscope. It is also used to flush air through these channels to expel fluids.

Follow the device manufacturer’s IFU to attach the injector tube to the scope.

Attach the FlexiPump tube set luer locks to the suction channel port and air/water port of the injector tube. Directions may vary depending on the scope and the manufacturer.

Cap off all unused tubes on the FlexiPump Tube Set. If there are two channels on the endoscope, place a FlexiPump seal cap on the end of the third FlexiPump tube lead. If you are flushing only one channel or lumen, cap off the other two FlexiPump tube leads with luer end caps.

Select the appropriate flush function and speed (page 9) and flush the device.

Connecting flexible endoscopes to the FlexiPump Independent Flushing System

It is important to follow the manufacturer’s instructions for use (IFU) for each flexible endoscope. The FlexiPump system

replaces the syringe flushing method in the pre-cleaning sections of these IFU.*

IMPORTANT:

 Most endoscope manufacturers specify how much cleaning solution to flush through the device. Follow IFU's to

prepare the cleaning solution. Carefully monitor all device exit points for flowing cleaning solution to ensure copious flushing.

 Be sure to rinse devices per manufacturer’s IFU.  To eject solutions from a scope, remove the drop-down tube from the reprocessing fluid container. Allow pump to

run. This will inject air into the scope and purge fluid from the device. Then continue to next reprocessing step.

9

OPERATION (continued)

Flushing flexible endoscopes with the FlexiPump Independent Flushing System

PSI Settings

Please refer to the manufacturer’s IFU for each endoscope’s pressure requirements. The FlexiPump system can be used with a low-pressure tube set or a higher-pressure tube set. In general, smaller flexible devices (urology scopes and bronchoscopes, for example) require lower pressure.

General rules and guidelines for flexible endoscope speed control

There are three (3) tubes on each FlexiPump tube set. IF ANY TUBES ARE NOT IN USE, BE SURE THEY ARE SECURED WITH END CAPS PROVIDED IN THE TUBE SET.

 When using all three tubes of the tube set for flushing, the MEDIUM or HIGH FlexiPump speed should

be used.

 When using two tubes, make sure the third tube is capped and the FlexiPump is set for LOW, MEDIUM

or (in some cases) HIGH speed.

 When using only one of the three tubes of the FlexiPump tube set, cap off the other two tubes and set

the FlexiPump speed to LOW, MEDIUM or (in rare cases) HIGH speed.

If the pump sounds or looks stressed, turn the speed setting down to avoid unnecessary wear on the motor.

PLEASE NOTE: the FlexiPump Independent Flushing System is intended for pre-cleaning and flushing of lumened devices. It is not for final treatment and does not replace manual brushing and rinsing. Refer to each medical device manufacturer’s instructions for use for complete pre-cleaning instructions.

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The Forward flush cycle is used for flushing channels. There are three options for this cycle: 30 seconds, 60 seconds and 90 seconds.

The Impact cycle is used ONLY for devices that are clogged. The FlexiPump tube set must be decontaminated after each Impact Cycle run.

The Speed Indicator shows one, two or three lights, to indicate the pump speed selected.

Too much pressure and speed can cause tube set damage.

Key Pad Operation

 Impact: press for clogged devices. Press the button ONCE for two (2)

minutes, TWICE for four (4) minutes, and THREE TIMES for six (6) minutes.

 STOP: press to stop all pump action and cancel any cycle  Forward Flush: press the button ONCE for 30 seconds, TWICE for 60

seconds and THREE TIMES for 90 seconds

 Speed Control: Push the button ONCE for low (500 ml per minute),

TWICE for medium (750 ml per minute), and THREE TIMES for high speed (1,000 ml per minute)

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MAINTENANCE

Decontaminating the tube set

Disinfect the tube sets at least daily, preferably at every shift change.

Step 1. Pour ready-to-use disinfectant into an open, clean container. Step 2. Submerge the drop-down tube in the container with disinfectant. Step 3. Set speed control on Low (1 LED light). Step 4. Press the START button to begin fluid flow. Step 5. Press STOP when the tube set is completely full of disinfectant. Step 6. You may need to place end cap(s) on the tube(s) to hold the disinfectant inside the tube set for the

full

contact time.

Step 7. Disinfectant should remain inside each tube for five (5) minutes. Step 8. Fill a cleaning solution caddy with clean water. Step 9. Place drop-down tube into the water and press START to rinse out the tubing.

Bleach or alcohol disinfectants are not compatible with the FlexiPump; it must be water based.

Cleaning FlexiPump surfaces

The surfaces of the system should be cleaned daily and whenever there is visible soil.

Step 1. Wipe all external surfaces with a ready to use disinfectant, including the tubing, and

allow them to air-dry.

Step 2. Wipe the surfaces of the Nest accessory and/or Rail accessory (if used) and let them air-dry.

Replacing the tube set

There are several important reasons why it is necessary to replace the tube set every month:

1. Infection prevention: hard water deposits could potentially build up on inside surfaces of the tube set

2. Reduced flow rate: the squeeze tube can lose its elasticity with time and use

3. Reduced pump life: the factory-applied tube set lubricant eventually wears away, resulting in more resistance

and more work for the pump. This can reduce the pump’s overall useful life

12

MAINTENANCE (continued)

1. Remove the Pump Cap by pressing on both side tabs

and pulling gently.

2. Unthread the tubing from around the squeeze tube rotor.

3. Thread the new tube set around the rotor, making sure it is properly aligned and the tube fittings are properly situated in the cap fittings.

4. Place the cap back onto the base, making sure it snaps down fully.

Instructions for replacing the tube set:

Flow validation and decontamination records:

These daily activities should be recorded and maintained as part of the department’s quality system. A daily log sheet template is included in this manual (page 17) for convenient recording of daily flow and

decontamination testing.

13

TROUBLESHOOTING

Problem

Recommendation

Notes

1. No power to unit

Disconnect the black and gray cords at the barrel connector. Reconnect making sure they are tight. If there is no power, slightly turn the adapter to engage the two and tighten. Repeat as necessary.

2. Power to unit but

buttons don’t work

Disconnect the black and gray cords at the barrel connector. Reconnect making sure they are tight. If there is no power, slightly turn the adapter to engage the two and tighten. Repeat as necessary.

3. Pump is not working

Disconnect the power cord from outlet and from the FlexiPump unit. Reconnect the cord and plug in. Press a control button to see if it works

If it still doesn’t work, go to #4

4. Pump does not work

If it still does not operate, contact Pure Processing Customer Service.

solution is coming out the end of the device

Make sure the drop-down tube is fully submerged. Also check for kinks in the tubing. Make sure you have the correct end of the tubing in the solution.

6. Luer lock is broken or separated from the tubing

7. Devices are not clean

Check the device manufacturer’s cleaning recommendations. Check the

disinfectant instructions for use. Confirm that all directions have been properly followed.

8. Impact Cycle is not working

Impact Cycle works in conjunction with detergent. Ensure that proper detergent is used for the type of soil in the device (protein-based enzyme for blood, e.g.).

If still not working, see #7

9. Impact Cycle is not working

Conduct a flow validation test:

 Place drop-down tube into container of clean water  Press the Forward Flush button once for a 30-second flush  When a steady stream of water exits the connector, press the Stop

button

10. Water is leaking from under the cap

 Check the tube set for cracks  Change the tube set if cracked

11. One or more components on the tube set are broken

 Replace the entire tube set

12. Unit is not running and I have a red blinking light

 Allow the unit to cool down for 30 minutes, and then resume use.  Contact us if this does not remedy the issue.

This can occur after prolonged use.

13. Speed control is stuck on HIGH

14. Unit makes lots of noise

 Use a surface liner under the nest to reduce vibration

15. Unit stopped while flushing

 Unplug the unit to reset it  Repeat interrupted flushing cycle

16. Pump cap will not stay locked to the base

 Replace the cap

Probably cracked or broken where locks engage

5. Rotor is spinning but no

Reset the unit by hitting stop, and then press the Forward Flush 30second button.

Change the tube set.

 Allow the unit to reset for 15 seconds. Press the speed

control to test.

If it still does not operate, contact Pure Processing Customer Service.

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FLEXIPUMP REPLACEMENT PARTS

Item

Product Code

FlexiPump™ Power Supply

FlexiPump™ Pump Cap

FlexiPump™ Pump Rotor

FlexiPump™ Nest Accessory

FLX-NEST

FlexiPump™ Sink Well Adapter

FPSWA-01

FlexiPump™ Irrigation Tube Set Two-Lead, 15 psi or 30 psi

FlexiPump™ Irrigation Tube Set Three-Lead, 15 psi or 30

psi

FXITS-0215psi6

FXITS-0230psi6

FXITS-0315psi6

FXITS-0330psi6

FPPS-01

FLX-CAP-01

FLX-ROTOR-01

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REPLACEMENT ADAPTERS

Item

Product Code

End Cap (to seal FlexiPump tube)

PSFP-LLSC-10

Female-to-Female Luer Lock

FFLL-10 FFLL-30 FFLL-50

Large Rubber sealing bridge

Rblg-01

Rubber Cup Adapter

RCA-01

Small Sealing Bridge

Rbsm-01

XL Slip Tip Adapter

XLSLIP-10 XLSLIP-20 XLSLIP-30

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ADDITIONAL ACCESSORIES

Item

Product Code

PSC240-1

Pro-Spray™ Ready-to-Use Disinfectant/Cleaner, 1 GAL.

PSC128-1

PSFP1616-EYE PSFP1626-EYE

PS1626FP

PS1626

PS1616FP

PS1616

These products are available from Pure Processing, Inc. and are compatible for use with the FlexiPump system:

PureChannel™ Flush Instrument Channel Cleaner

• 1 gallon size

• 32 oz. size

Pro-Spray™ Ready-to-Use Disinfectant/Cleaner, 24 oz.

PureStation™ Sink Insert

PureStation™ Sink Insert with FlexiPump(TM) Independent Flushing

System (large)

PureStation™ Sink Insert (large)

PureStation™ Sink Insert with FlexiPump(TM) Independent Flushing

System (small)

PSCF-08 PSCF-32oz

PureStation™ Sink Insert (Small)

17

Day

Decontamination Procedure

Initials

1

Yes

No

2

Yes

No3 Yes

No4 Yes

No5 Yes

No6 Yes

No

7

Yes

No

8

Yes

No9 Yes

No

10

Yes

No

11

Yes

No

12

Yes

No

13

Yes

No

14

Yes

No

15

Yes

No

16

Yes

No

17

Yes

No

18

Yes

No

19

Yes

No

20

Yes

No

21

Yes

No

22

Yes

No

23

Yes

No

24

Yes

No

25

Yes

No

26

Yes

No

27

Yes

No

28

Yes

No

29

Yes

No

30

Yes

No

31

Yes

No

Month and Year

Unit Number

FlexiPump™ Independent Flushing System

Daily Assurance Log

Tube Replacement Name: Date:

Day

Flow Validation Test

Initials

1

Pass

Fail

2

Pass

Fail3 Pass

Fail4 Pass

Fail5 Pass

Fail6 Pass

Fail

7

Pass

Fail

8

Pass

Fail9 Pass

Fail

10

Pass

Fail

11

Pass

Fail

12

Pass

Fail

13

Pass

Fail

14

Pass

Fail

15

Pass

Fail

16

Pass

Fail

17

Pass

Fail

18

Pass

Fail

19

Pass

Fail

20

Pass

Fail

21

Pass

Fail

22

Pass

Fail

23

Pass

Fail

24

Pass

Fail

25

Pass

Fail

26

Pass

Fail

27

Pass

Fail

28

Pass

Fail

29

Pass

Fail

30

Pass

Fail

31

Pass

Fail

Pure Processing Customer Support 1-877-718-6868

Pure Processing FlexiPump User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual