Quick Start Note: Loading a Series 300 SAK

This Quick Start Note describes the SAK loading procedures for the Series 300 SAK.

Applicability

The Series 300 Dialysate Sacks can be used only with PureFlow SL Control Units that are running PureFlow SL software release 1.13 or higher.

SAK-30x Loading Procedures

WARNING:

This device is for single use only. Do not reuse or resterilize. Materials used in the manufacture of the device may not withstand reprocessing or reuse or both. Reuse or resterilization of the device may result in, but is not limited to, any or all of the following: risk of cross contamination, material degradation, biocompatibility issues, endotoxic reactions, and failure of the device to perform as intended.

PRECAUTION:This product contains DEHP which is commonly used to make PVC plastics more pliable. Animal studies indicate that repeated or prolonged DEHP exposure may result in adverse reproductive or developmental effects or both. While there is no conclusive data regarding the adverse effects in humans from DEHP exposure, certain populations such as children and pregnant or nursing women may be at the highest risk. Prior to using this

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product, consult with your physician for further information.

NOTE: Refer to the NxStage PureFlow™ SL Software Version 1.13 User’s Guide for complete information and instructions for using the PureFlow SL in order to ensure the safe and appropriate use of your PureFlow SL.

Loading the SAK-30x

To load the SAK, follow these steps:

Step 1. Ensure that the PureFlow SL is on and in STANDBY.

O

Step 2. Press GO. The following displays:

Step 3. Remove the SAK from the package. Step 4. Before unfolding the SAK, check for leaks by squeezing

the SAK. If a leak is found, do not use the SAK.

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Step 5. Verify that the SAK type you are using matches the SAK type shown on the Control Panel Display. If it does not match, press and hold STOP to return to Standby and then change the setting as instructed in the “Changing the Dial-ysate SAK Type” section found on pages 6-8 and 6-9 of your NxStage PureFlow SL Software Version 1.13 User’s Guide.

Step 6. Open the cabinet door on the PureFlow SL and pull out the Tub.

Tub

Note that the tub does not pull out as far as shown. This is for illustration purposes only.

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Step 7. Place the SAK into the center of the bottom of the Tub with the label facing you.

Step 8. Slide back the folded SAK until it touches the back of the Tub wall. The back edge of the SAK must touch the back wall of the Tub as shown in the following picture.

Back edge of the SAK touching the back wall of the Tub.

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Step 9. Unfold the SAK so the label is against the back wall of the Tub, as shown in the following picture.

Step 10. Unfold the front fold of the SAK toward the front of the Tub.

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Step 11. Remove and discard the protective foam sheet between the SAK lines and the SAK bag.

Step 12. Gently push the SAK against the front wall of the tub, as shown in the following picture, to ensure it seats properly.

Protective Foam Sheet

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Note: The SAK must be loaded into the Tub so that when it is unfolded, the front and rear of the SAK are at the same height. The SAK is folded and packaged so this should occur automatically, but it is important to verify. If the SAK is not loaded properly alarms might occur.

Step 13. Remove the piece of tape holding the lines.Step 14. Uncoil the SAK lines and verify that none of the lines are

kinked or crossed.

Note: SAK lines adjacent to the Line Collar Assemblies are intentionally folded for shipping purposes.

Step 15. Open the Control Panel Door.

Front of SAK

Front of PureFlow SL

Rear of SAK

Rear of PureFlow SL

Tub (Transparent Side View)

Same Height

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Step 16. Open the Dialysate Pump cover by lifting it up.

Step 17. Ensure that the lines are not twisted around each other. Insert the Five Way Connector and the elbow joint into the retaining clips and run the lines through the channels as shown in the following picture. The Dialysate Pump Line (large diameter line) must be pointing to the right.

NOTE: You might need to slide the Tub into the chassis in order to create some slack in the SAK lines.NOTE: The 0.2 micron filter is NO longer inserted behind the Control Panel door.

Five-Way Connector

Retaining Clip

Previous Location of 0.2 Micron Filter

Elbow Joint on the SAK Water Inlet Line

Retaining Clip

SAK WaterInlet Line

Dialysate Outlet Line

Dialysate Pump Line

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Step 18. Run the Dialysate Pump Line through the Dialysate Pump.

Step 19. Close the Dialysate Pump Cover.

NOTE: Make sure that the Dialysate Pump Line of the SAK is centered in the pump prior to closing the Dialysate Pump cover.

Dialysate Pump Line

Dialysate Outlet Line

SAK Water Inlet Line

Conductivity Line (Orange Clamp)Blue Check Valve Line

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Step 20. Close the Control Panel Door. NOTE: You cannot close the Control Panel Door if the Dialysate Pump cover is open.

The Control Panel Door should close as easily as the door of a microwave oven. If it does not close easily, do NOT force it closed. Check that all of the lines are properly seated in the channels and that they are not being pinched by the Control Panel Door. To verify that the lines are properly seated in the channels, gently move them from left to right where they exit from under the Control Panel Door. They should move freely and they should hang straight down.

Step 21. Locate the lines with the Line Collar Assemblies exiting from the SAK.

Control Panel Door

Lines hanging from channels

Dialysate Outlet Line

Front of TubLine Collar Assemblies

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Step 22. Pull the lines on each side of the fold to release the fold. Repeat for the second line.

Step 23. Slide the Line Collar Assemblies over the previously folded areas on both lines. Failure to do so may cause flow restrictions, which in turn, may create an alarm condition, such as an A14 Compromised SAK or an A51 Output Pressure High.

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Step 24. Wait at least two seconds after closing the Control Panel Door. The display should then tell you to Connect Lines.

NOTE: If a new PAK has just been primed, continue with Step 25. If not, skip to Step 26.

Step 25. Disconnect the PAK Water Outlet from the Conductivity Sensor Connector.

Conductivity Sensor Connection

PAK Water Outlet Line Short Line Segment

Waste

Connectivity

Water Outlet

Yellow

Orange

White

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Step 26. Disconnect the Short Line Segment (with the blue non-reopening clamp) from the PAK Water Outlet Line.

Step 27. Remove the protective cap from the SAK Water Inlet by flipping the cap up.

Blue Non-Reopening Clamp

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Step 28. Connect the PAK Water Outlet Line to the SAK Water Inlet Line (blue clamp).

Step 29. Remove the Connector Tab on the SAK Water Inlet by first pinching and then pulling the Tab as shown.

Blue Non-Reopening Clamp

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Step 30. Verify that the Luer Connection on the SAK Water Inlet Line is tight by turning the blue rotating collar clockwise until tight.

Step 31. Drape the SAK Water Inlet Line into the Dialysate Tub. Ensure that the 0.2 micron filter is also placed in the Tub.

Step 32. Unclamp the blue reopening clamp on the PAK Water Outlet Line connecting to the SAK.

Step 33. Remove the cap from the SAK line with the orange clamp.

Blue Rotating CollarBlue Non-Reopening Clamp

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Step 34. Connect the line to the Conductivity Sensor Connector on the CU.

Step 35. Completely slide in the Tub and close the cabinet door.Be sure that the lines do not get caught in the cabinet door and are not kinked.

Waste

Connectivity

Water Outlet

Yellow

Orange

White

NOTE: Once the SAK has been loaded and properly connected, refer to page 5-18 of your NxStage PureFlow SL Software 1.13 User’s Guide for instructions on how to make a batch of dialysate.

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MEDISYSTEMS EUROPE, S.P.A.Via G. Galilei, 20Sorbara Di Bomporto (MO)Italy 41030

NxStage Medical, Inc.439 South Union Street 5th FloorLawrence, MA 01843 USATel: 978-687-4700

©2011 NxStage Medical, Inc. This document is not intended to replace the NxStage System One™ or Pure-Flow SL User’s Guides. Refer to the System One and PureFlow SL User’s Guides for all warnings and precau-tions. NxStage is a registered trademark of NxStage Medical, Inc. System One and PureFlow are trademarks of NxStage Medical, Inc. CAUTION: Federal Law restricts this device to sale by or on the order of a physician.

For NxStage Customer Service (US only):

1-866-NXSTAGE (1-866-697-8243)Fax: 978-687-4809Email: customerservice@nxstage.com

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