equipment redeployment...

Equipment Redeployment Instructions


ii NC3927 Rev A 2012/02/29

This document is not intended to replace the NxStage System One or PureFlow SL User Guide or Cartridge Instructions for Use. Patients, partners, and providers should review and refer to the System One or PureFlow SL User Guide or Cartridge Instructions for Use for all warnings and precautions.

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

© 2012 NxStage Medical, Inc. All rights reserved.

This document contains proprietary and confidential information of NxStage Medical, Inc. The contents of this document may not be disclosed to third parties, copied, or duplicated in any form, in whole or in part, without the prior written permission of NxStage Medical, Inc.

NxStage is a registered trademark and System One, PureFlow, ComfortMate, ConNxBox, and NxRx, are trademarks of NxStage Medical, Inc.

NC3927 Rev A 2012/02/29 iii

Contents

Introduction ....................................................................................................................... 1

Redeployment General Information .............................................................................. 3

Prior to Equipment Return to Center ............................................................................. 4

I. Train Center Personnel .............................................................................................. 4

II. Ensure Redeployment Supplies are Available ..................................................... 5

Redeployment Steps ......................................................................................................... 7

Return Equipment to Center or NxStage ................................................................... 7

Cycler ............................................................................................................................... 8

Cycler Base and Fluid Detection Sensor ..................................................................... 9

Express Fluid Warmer ................................................................................................. 10

ComfortMate Warmer and Table Top Stand ........................................................... 11

PureFlow SL Control Unit .......................................................................................... 12

PureFlow SL Cabinet with or without Wheeled Base ............................................ 14

Patient Start-up Using Redeployed Equipment ...................................................... 15

Redeployment Procedures ............................................................................................. 16

I. Decontaminate Exterior Surfaces of Equipment and Accessories ......................... 16

II. Cycler ........................................................................................................................ 19

III. PureFlow SL ............................................................................................................ 22

Redeployment Forms ..................................................................................................... 31

Redeployment Training Documentation Form ....................................................... 32

Equipment and Accessories Form ............................................................................. 33

Redeployment Documentation Form ....................................................................... 34

Patient Equipment Log Form ..................................................................................... 35


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NC3927 Rev A 2012/02/29 1

Introduction NxStage® System OneTM equipment, including the System One Cycler, Cycler base, Fluid Detection Sensor, fluid warmer, PureFlowTM SL control unit, and PureFlow SL cabinet, can be redeployed from one patient to another by the dialysis center without first being returned to NxStage.

These instructions provide information supporting this policy; and the steps, procedures, and documentation tools needed by dialysis centers to safely redeploy equipment from one patient to another.

Any equipment being redeployed is required to be readied for redeployment per these Equipment Redeployment Instructions and dialysis center standard procedures.

Supporting Information • The system is designed with disposable fluid pathways, cartridge, as well

as disposable supplies Purification PAK, Dialysate SAK, fluid warmer bags, and/or pre-packaged single-use dialysate fluid bags to minimize fluid contact with equipment.

• The fluid pathway contacts the PureFlow SL equipment at the waste line and conductivity sensor connectors. These connectors and lines within and exiting the control unit are automatically flushed by the system at various stages of operation, and are required to be flushed with bleach solution periodically by the user and prior to redeployment of the equipment, per NxStage user instructions. These procedures, as well as the positive-pressure nature of the PureFlow SL system, are designed to prevent the chance of cross-contamination.

• The System One, PureFlow SL, and fluid warmer each have extensive built-in self-tests that are designed to ensure the equipment is working properly before each use by a patient.

• The software of the NxStage System One Cycler and PureFlow SL units is designed to automatically alert the user when the units should be returned to NxStage for preventive maintenance.

Introduction Equipment Redeployment Instructions

2 NC3927 Rev A 2012/02/29

• Redeploying NxStage equipment in this manner is similar to redeploying conventional in-center dialysis equipment from one patient shift to the next in the in-center dialysis setting. Through the use of disposable fluid pathways, proper disinfection and decontamination procedures, and equipment design, redeploying equipment from one patient to another can be done safely and effectively by the dialysis center without returning the equipment to the manufacturer.

• NxStage equipment is also routinely used on sequential patients in the Intensive Care Unit (ICU) setting because of the system’s built-in self tests, disposable fluid pathway, and proper adherence by facility staff to maintenance and redeployment procedures.

NC3927 Rev A 2012/02/29 3

Redeployment General Information In the event of unusual circumstances or specific questions about the decontamination or redeployability of NxStage equipment, contact Technical Support at 1-866-NXSTAGE (866-697-8243) and select option 1.

All equipment from a patient who has discontinued therapy with NxStage should be returned to the center as soon as possible.

• All equipment must be packaged appropriately in NxStage shipping cartons.

• Upon request, NxStage Customer Service can arrange for equipment to be returned from the patient discontinuing therapy to the center. Refer to the center’s NxStage Medical, Inc. Chronic Outpatient Therapy Agreement (“the agreement”) Schedule B-4 for the cost of this service.

• Once the equipment has been returned to the center, perform redeployment steps and procedures as soon as possible.

• Always use universal precautions. Use the supplies defined by your center to prevent cross contamination and to provide protection from the cleaning and disinfecting supplies.

Precaution Take precautions at all times to prevent exposure to or transmission of infectious agents.

• Any equipment returned to NxStage requires a Return Authorization (RA) number that can be obtained by calling 1-866-NXSTAGE and selecting option 1 (Technical Support). Charges may apply.

Patients and center staff should follow all NxStage instructions regarding the use, maintenance, and redeployment of equipment.

• Refer to product user guides for all instruction for use, maintenance procedures, and warnings and precautions. Failure to follow instructions may cause damage.

• Refer to the “Redeployment Steps” section and “Redeployment Procedures” for detailed instructions describing the equipment redeployment. Failure to follow instructions may cause damage.

Note: The NxStage Pre-Treatment Unit and is not redeployed.

Prior to Equipment Return to Center Equipment Redeployment Instructions

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Upon redeployment of equipment to another patient, center staff should notify NxStage Medical Customer Service of the redeployed equipment serial number(s) to ensure the center’s NxRxSM patient equipment inventory records are accurate.

Prior to Equipment Return to Center

I. Train Center Personnel Make sure that each person who prepares equipment for redeployment understands all redeployment steps and procedures.

The trainer must:

1. Make sure that personnel review these complete instructions. 2. Demonstrate redeployment steps and procedures. 3. Monitor personnel’s ability to perform redeployment steps. 4. Complete the “Redeployment Training Documentation Form” on page 32

and retain the completed document in the employee’s file.

Equipment Redeployment Instructions Prior to Equipment Return to Center

NC3927 Rev A 2012/02/29 5

II. Ensure Redeployment Supplies are Available Gather supplies as follows: A. Cleaning solution:

• Create one-half (1/2) gallon of a mild detergent using the detergent manufacturer’s product cleaning directions.

B. Disinfecting solution: • Create one-half (1/2) gallon of a 1:10 bleach and water solution using

one part 6.15% sodium hypochlorite (household bleach) to nine parts water. Approximate dilutions are three-quarters (3/4) cup of bleach in one-half gallon of water.

Note: If using bleach (sodium hypochlorite) of a different concentration, ensure the final solution has 5000-6000 parts per million (ppm) available chlorine.

- 90 ml of this bleach solution is used to disinfect the PureFlow SL conductivity sensor and drain line, the rest is used to disinfect the exterior surfaces of equipment and accessories.

- Use the bleach solution within 24 hours of preparation. - 6. 15% sodium hypochlorite is an Environmental Protection

Agency (EPA) Registered Antimicrobial Product, effective against mycobacterium tuberculosis, Human HIV-1, and Hepatitis B virus.

- Recommended solution concentration and contact time may differ for certain known pathogens in order to adequately disinfect surfaces. If a specific known pathogen is suspected, follow the bleach manufacturer’s disinfection directions for that pathogen.

C. Other supplies: • 30 ml syringe • Recirculation connector • Soft brush • Personal Protective Equipment per center procedures (such as gloves,

face shield, gown) • Clean cloths • Soft extra-low lint cloth • NxStage System One User’s Guide (NC2320) “Appendix A: System Settings.”

Prior to Equipment Return to Center Equipment Redeployment Instructions

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D. Patient redeployment Kits:

1. If the new patient is known and the therapy prescription is completed, provide the prescription with the redeployed equipment serial numbers to NxStage Customer Service. You will automatically receive the appropriate Patient Redeployment Kit:

• NX0730 PureFlow Patient Redeployment Kit − This kit is for a new patient using the Cycler (with or without Cycler base and Fluid Detection Sensor), warmer and PureFlow SL. It contains user guides for the System One, PureFlow SL, Cycler Base, and fluid detection sensor, and either the ComfortMate™ or Express Fluid Warmer. In addition the kit contains a document summarizing the Emergency Rinseback procedure, an Air Filter media, a USB thumb drive, a Conductivity Preventive Maintenance (CPM-001) Kit, and a Pre-Treatment Kit including water and drain lines.

• NX0731 Express Patient Redeployment Kit − This kit is for a new patient using the Cycler (with or without Cycler base and Fluid Detection Sensor) and warmer (patient not using PureFlow SL). It contains user guides for the System One, Cycler base and fluid detection sensor, and either the ComfortMate or Express Fluid Warmer. In addition, the kit contains a document summarizing the Emergency Rinseback procedure and a USB thumb drive.

- OR -

2. If the new patient is not known, ready the equipment for redeployment and store until required.

• If redeploying the PureFlow SL, call NxStage Customer Service to order the NX0730 PureFlow SL Patient Redeployment Kit. You will need some of kit components to perform the PureFlow SL redeployment procedures.

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Redeployment Steps Note: The following pages (7-15) outline the redeployment steps (in algorithm

format) to return and redeploy the NxStage System One equipment and ancillary components. Pages 16 – 30 provide redeployment procedures, which are step-by-step instructions to perform certain redeployment steps (for example, how to decontaminate equipment and exterior surfaces).

Personnel performing redeployment should follow the redeployment step algorithm sequence for each piece of equipment and refer to the redeployment procedures for additional instructions to complete each step. Simple redeployment steps (for example, plug in the Cycler or touch the stainless steel bars with a moistened soft cloth) are not further explained within the redeployment procedure section.

Return Equipment to Center or NxStage

Equipment is picked up by NxStage and returned to NxStage (Fees for Service on “the agreement” Schedule B-4.)

Equipment is at the center or NxStage.

OR OR

Equipment is picked up by NxStage and returned to the center. (Fees for Service on “the agreement” Schedule B-4.)

Retrieve equipment from the patient’s home and return to the center or NxStage as soon as possible.

Equipment is picked up by the center (may use local courier service) and returned to the center.

When the patient discontinues NxStage therapy, complete FORM236 System One Patient/Customer

Status Form (available on NxRx).

Equipment is at NxStage, no further action is required.

* Always use universal precautions.

Redeployment Steps Equipment Redeployment Instructions

8 NC3927 Rev A 2012/02/29

Cycler

Are anyof the items damaged?

Upon “power on”,

the control panel flashes 888s.

Are any of the items missing?

Order replacement. Refer to “Equipment and Accessories Form” on page 33.

Call Technical Support:

1. Obtain a NxStage Return Authorization (RA) # to return the Cycler to NxStage. Replacement or preventive maintenance is required.*Note: Discard, do not return damaged accessories.

2. Order replacement Cycler. Accessories are sent with replacement Cycler.*

*Charges may apply.

Plug in Cycler and turn ON.

NO

NO

YES

Is Caution 71 displayed in Yellow Caution

Status Bar?

YES

Disinfect the interior surface of the Cycler and clean the blood leak detector. Dispose of used decontamination supplies.

Is thenew patient identified?

Refer to “Patient Start-Up Using Redeployed Equipment” on page 15.

Complete “Redeployment Documentation Form” on page 34.

Adjust the Cycler System Settings to the default values.

Store Cycler (power off and closed) with filter holder and the power cord until

the new patient is identified.

NO

YES

NO

YES

NO

YES

Inspect items:• Cycler• Filter holder• 12 ft. power cord

Decontaminate equipment and accessories.


Equipment Redeployment Instructions Redeployment Steps

NC3927 Rev A 2012/02/29 9

Cycler Base and Fluid Detection Sensor

Call Technical Support for guidance. Charges may apply.

Order replacements. Refer to “Equipment and Accessories Form” on page 33.

Insert a new battery into the sensor.


Touch the sensor’s stainless steel bars with a moistened cloth.



Upon insertionthe sensor beepswhen the battery

is connected?


Decontaminate equipment and accessories, then dispose of used decontamination supplies.

Uponcontact the sensor

alarms?

YES

NO

YES

NO

YES

NO

NO

YES

Refer to “Patient Start-up Using Redeployed Equipment” on page 15.


Is the new patient

identified?

Remove the battery from the sensor and store Cycler base and sensor until the new patient is identified.

NO

YES

Inspect items:• Cycler base• Fluid detection sensor



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Express Fluid Warmer

Call Technical Support :

1. Obtain RA # to return damaged warmer to NxStage.*Note: Discard, do not return damaged accessories.

2. Order a replacement warmer. Accessories will be sent with replacement.*

*Charges may apply.

Connect the interconnect power cord from the Cycler (which is connected to power) to the warmer.





Upon power cord connection, the Express

Fluid Warmer’s comfort status lights flash red, yellow then green and the standby and hot surface indicators come on then go off. An alarm sounds,

all lights go out and the standby light remains lit.

Is the new patient

identified?


Store warmer and accessories with interconnect power cord disconnected from the

warmer until the new patient is identified.

NO

NO

YES

YES

NO

YES

YES

NO


Inspect items:• Express Fluid Warmer• Express Fluid

Warmer bag cover• IV pole• Interconnect power cord• Top mount• Bottom mount• Screws



NC3927 Rev A 2012/02/29 11

ComfortMate Warmer and Table Top Stand



1. Obtain RA # to return damaged warmer to NxStage.*Note: if the table top stand or accessories are damaged, discard with 4-hanger top and screws, do not return to NxStage.

2. Order a replacement warmer. Accessories will be sent with the replacement.*

*Charges may apply.



Connect the interconnect power cord from the warmer to the powered on Cycler and power ON the warmer.


Is the new patient

identified?


Upon “power on”, the warmer

control panel lights flash, an alarm sounds, and the

green light on the frontof the warmer

remains lit.

Store warmer (power off and closed) with interconnect power cord and table top stand until new patient identified.

NO

NO

YES

YES

NO

YES

YES

NO


Inspect items:• Warmer• Table top stand• IV pole with 4-hanger top• Interconnect power cord• Screws



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PureFlow SL Control Unit

Are anyof the items damaged or corroded?

If not previously ordered, call Customer Service and order NX0730 PureFlow SL Patient Redeployment Kit.

Plug in PureFlow SL and power ON.

Order replacement. Refer to “Equipment and Accessories Form” on page 33.

Call Technical Support: 1. Obtain an RA # to return the

control unit. Replacement or preventive maintenance is required.*Note: Discard, do not return damaged accessories.

2. Order replacement control unit and accessories as required.*

*Charges may apply.

Is the UV light PM status due in less than

than 156 batches?

Upon “power on”, is Caution 2 or Alarm

853 displayed?

Upon “power on”, the control panel LED’s

flash: green, yellow, red and thecontrol panel displays “NxStage

Medical Inc “ and software version.


Check ultraviolet (UV) light preventive maintenance (PM) status.

NO

NO

NO

YES

YES

NO

YES

YES

NO

Continued on next page

Inspect items:• PureFlow SL control unit• Interconnect power cord• 12 ft. power cord

(if returned)• Saline hook• USB cable• J1 cable

Discard pre-treatment kit, if returned.

YES



NC3927 Rev A 2012/02/29 13

PureFlow SL Control Unit – continued:

Disinfect the conductivity sensor.

Is thenew patient identified?

Decontaminate equipment and accessories. Then dispose of used decontamination supplies.

Disinfect the drain line.

Replace air filter media.Note: Do not remove the screws from the plastic fan guard on the back of the PureFlow SL.


Complete form “Redeployment Documentation Form” on page 34.

NO

YES

Perform the CPM-001 Procedure.

Check PM status of conductivity sensor.

Is the conductivity sensor PM due in less

than 300 days? YES

Store PureFlow SL control unit (power off) (within cabinet, if available) with interconnect power cord, 12 ft. power cord (if available), saline hook, J1 and USB cables until the new is patient identified.

NO

Continued from previous page.



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PureFlow SL Cabinet with or without Wheeled Base

Decontaminate equipment and accessories then dispose of used decontamination supplies.

Complete the form “Redeployment Documentation Form” on page 34.

Order replacement items (unless ordered with control unit redeployment). Refer to “Equipment and Accessories Form” on page 33.



1. Obtain an RA # to return Cabinet to NxStage.*Note: If the PureFlow SL wheeled base is damaged, discard, do not return to NxStage.Note: Discard, do not return damaged accessories.

2. Order replacement cabinet and accessories as required.*

*Charges may apply.


Is the new patient

identified?

Store PureFlow SL Cabinet (closed) with interconnect power cord, 12 ft. power cord (if

available), saline hook, J2 cable, dialysate tub, and USB cables until the new patient is identified.

YES

NO

NO

YES

YES

NO

Are anyof the items damaged or corroded?

PureFlow SL cabinet, wheeled base (if returned).Inspect items if not inspected with control unit:• Interconnect power cord• 12 ft. power cord (if returned)• Saline hook• USB• J2 cable• Dialysate tub cable



NC3927 Rev A 2012/02/29 15

Patient Start-up Using Redeployed Equipment

Provide redeployed equipment with the previously ordered Patient Redeployment Kit components to patient.

1. Provide the new patient prescription to NxStage (via NxRx) with the redeployed equipment serial number(s). (Serial numbers do not exist for the Cycler base, fluid detection sensor or the table top stand).

2. Once the prescription is received, NxStage Customer Service will call the center to discuss the patient’s equipment and supplies. NxStage will send (unless previously sent) either:

NX0731 Express Patient Redeployment Kit if redeploying the Cycler with only a warmer.

or NX0730 PureFlow SL Patient Redeployment Kit if redeploying the Cycler, warmer, and PureFlow SL.

Is the new patient prescription provided to

NxStage?

Verify NxStage NxRx Center Inventory Report is accurate for this patient.

Report any discrepancies to NxStage Asset Management Department (978-687-4876).

YES

NO

Note: Appendix B: Patient Equipment Log is an optional form which may be used by the center to maintain a historical record of the patient’s equipment serial numbers.


Redeployment Procedures Equipment Redeployment Instructions

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Redeployment Procedures Complete the following procedures before redeploying equipment.

I. Decontaminate Exterior Surfaces of Equipment and Accessories This section covers the decontamination procedures for the Cycler, Cycler base and fluid detection sensor; PureFlow SL; Express Fluid Warmer; ComfortMate Fluid Warmer; and all equipment accessories.

The Pre-Treatment Kit is not redeployed.

Notes: • Therapy with the NxStage System One involves access to the patient’s

blood, thus potentially exposing equipment to pathogens. • Complete the following procedures to ensure patient safety by proper

cleaning and disinfecting of the NxStage equipment when returned equipment is being reissued to another patient.

• Clean and disinfect NxStage equipment in a well-ventilated environment. • Always use universal precautions. Use the supplies defined by your center

to prevent cross contamination and to provide protection from the cleaning and disinfecting supplies.

• Prior to decontaminating the PureFlow SL you must complete the following PureFlow SL redeployment steps (refer to the PureFlow SL redeployment procedures for instructions.):

“B. Check the Ultraviolet (UV) Light Preventive Maintenance (PM) Status”

“C. Check the Conductivity Sensor Preventive Maintenance (PM)” “D. Complete the CPM-001 Procedure” if required “E. Disinfect the PureFlow Conductivity Sensor” “F. Disinfect the PureFlow SL Drain Line”

A. Prior to decontaminating returned equipment 1. Remove all rings, bracelets, and watches. 2. Wear personal protective apparel. 3. Turn off the power to the equipment and disconnect power cords. 4. Clamp, disconnect, and dispose of all used disposables (PAK, SAK,

cartridge, warmer disposables, and control unit adapter), if present.

Equipment Redeployment Instructions Redeployment Procedures

NC3927 Rev A 2012/02/29 17

5. Prepare a mild detergent for cleaning equipment per the detergent manufacturer’s product cleaning directions.

6. Prepare disinfecting solution: • Create one-half (1/2) gallon of a 1:10 bleach and water solution using

one part 6.15% sodium hypochlorite (household bleach) to nine parts water. Approximate dilutions are three-quarters (3/4) cup of bleach in one-half gallon of water.

Note: If using bleach (sodium hypochlorite) of a different concentration, ensure the final solution has 5000-6000 parts per million (ppm) available chlorine.

- 90 ml of this bleach solution is used to disinfect the PureFlow SL conductivity sensor and drain line, the rest is used to disinfect the exterior surfaces of equipment and accessories.

- Use the bleach solution within 24 hours of preparation. - 6. 15% sodium hypochlorite is an Environmental Protection

Agency (EPA) Registered Antimicrobial Product, effective against mycobacterium tuberculosis, Human HIV-1, and Hepatitis B virus.

- Recommended solution concentration and contact time may differ for certain known pathogens in order to adequately disinfect surfaces. If a specific known pathogen is suspected, follow the bleach manufacturer’s disinfection directions for that pathogen.

B. Ready the equipment for decontamination

1. Place equipment on a clean suitable surface. 2. Close the Cycler door and push the handle down. 3. Open the PureFlow SL door and pull out the PureFlow SL dialysate tub. 4. Open the ComfortMate Fluid Warmer door. 5. Remove the fluid detection sensor from the Cycler base and remove and

discard the battery from the fluid detection sensor.


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6. Disconnect and remove the PureFlow control unit from the PureFlow SL cabinet by using the following steps: a. Disconnect the blue water line connecting the pre-treatment unit and the

water inlet on the rear of the control unit. b. If present, loosen the screws holding the pre-treatment unit bracket on

the rear of the PureFlow SL and lift the pre-treatment bracket off the PureFlow SL and discard. A new Pre-treatment Unit/Drain Line Basic Installation Kit is included in the NX0730 PureFlow SL Patient Redeployment Kit.

c. If present, disconnect the drain line from the control unit and discard. d. Open the PureFlow SL cabinet door. e. Loosen the two thumb screws located beneath the front of the control

unit. Pull out the dialysate tub for easier access to the thumb screws. f. Disconnect the cable labeled J1 from the UV light connector on the rear

panel (if present) and slide the end of the J1 cable on top of the UV light. g. Disconnect the USB cable from the USB connector on the rear panel (if

present). h. If present, disconnect the J2 cable from the dialysate tub connector. i. If present, disconnect the PureFlow SL heater power cord from the

heater power connection on the rear panel. j. If present, disconnect the power cord from the AC power connector on

the back of the control unit. k. Gently remove the control unit and place on a suitable flat surface.

l. Open the PureFlow SL control panel door and dialysate pump cover.

C. Cleaning and disinfecting exterior surfaces of equipment and accessories

1. Perform mechanical cleaning of the equipment exterior surfaces. Use a soft brush to remove any gross debris from the equipment prior to cleaning and disinfecting.


NC3927 Rev A 2012/02/29 19

2. Clean the equipment exposed surfaces with a soft clean cloth and the prepared cleaning solution except the control unit open UV light assembly area, the metal connections on the rear of the control unit, and the underside of the Jewel Box or ConNxBox™. Follow the detergent manufacturer’s instructions. Ensure all sides and surfaces of the equipment are cleaned.

Note: To prevent dripping of the solution, do not saturate the cleaning cloth with the cleaning or disinfecting agent. Do not immerse or pour any solution directly onto or inside the equipment.

Cycler PureFlow SL Cabinet PureFlow SL Control Unit Express Fluid Warmer

3. Disinfect the equipment with a cloth moistened with the prepared bleach solution and wipe all of the exposed surfaces of the equipment except the control unit open UV light assembly area, the metal connections of the rear of the control unit, and the underside of the Jewel Box or ConNxBox. The Cycler handle may need to be raised to completely disinfect the front of the Cycler. Ensure all sides and surfaces of the equipment are disinfected.

Cycler PureFlow SL Cabinet PureFlow SL Control Unit Express Fluid Warmer

4. Allow the bleach solution to remain on the equipment for ten minutes. 5. Use a new clean cloth and water to rinse off the bleach and allow to air dry. 6. Reassemble the equipment after cleaning and disinfecting per the

appropriate user guide or instruction for use.

II. Cycler A. Power on the Cycler and Respond to Cycler Caution # 71

If a Yellow Caution 71 is displayed in the Status Window, contact NxStage Technical Support to arrange for a replacement Cycler and a Return Authorization number to return the Cycler to NxStage.


20 NC3927 Rev A 2012/02/29

B. Decontaminate the Cycler Follow the “I. Decontaminate Exterior Surfaces of Equipment and Accessories ” instructions on page 16.

C. Disinfect the Interior Surface of the Cycler, Clean Blood Leak Detector and Mirror

1. Lift the Cycler handle up completely (until it clicks) and pull the Cycler door open to see the inside surface of the Cycler.

2. Dampen a clean cloth with the prepared cleaning solution and clean all exposed surfaces on the inside of the Cycler. Follow the detergent manufacturer’s directions for product cleaning. Do not clean sensors labeled Avoid Contact with Sensor (with yellow tags as indicated by the red circled area in the following figure), blood leak detector, and mirror to prevent mechanical damage.

3. Dampen a soft cloth with the prepared bleach solution and wipe all exposed surfaces of the inside of the Cycler. Do not clean sensors labeled Avoid Contact with Sensor (with yellow tags as indicated by the red circled area in the previous figure), blood leak detector, and mirror to prevent mechanical damage.

4. Allow the bleach solution to remain on the inside of the Cycler for ten minutes.

5. Using a new, clean cloth and water, rinse off the bleach and allow to air dry.


NC3927 Rev A 2012/02/29 21

6. Take a soft, extra-low lint cloth dampened with tap water and wipe the blood leak detector, mirror and air sensors free of dust and debris. The blood leak detector is a round shiny piece of glass on the lower, left-hand Cycler side. The matching mirror is a round depression located directly across from the detector on the Cycler door side.

7. Dry the blood leak detector, mirror and air sensors with a clean, soft, extra-low lint cloth.

D. Adjust Cycler System Settings to the Default Settings 1. Turn ON the power switch to the Cycler.

2. Listen closely for a beep and quickly press TREATMENT. This places the Cycler in System Setting mode.

3. Watch in the top window for the number 0 (for Cycler software version 4.6 and above) or 1 (for Cycler software versions 4.5 and below).

The top window displays the setting and the middle window displays the current value.

4. Press the top window ADJUSTMENT ARROWS up or down until desired system setting is selected.

5. Press the middle window ADJUSTMENT ARROWS up or down to change the current value to the default values for each setting, as listed in NxStage System One User Guide (NC2320) “Appendix A: System Settings.”


22 NC3927 Rev A 2012/02/29

6. Repeat the process for other System Settings as needed.

7. When finished, turn Cycler power OFF. This saves the chosen settings into memory.

Note: When the new patient is known, the system settings can be adjusted to meet the new patient’s needs.

III. PureFlow SL A. Power on the PureFlow SL and Respond to Caution 2 or Alarm 853

If a Caution 2 or Alarm 853 is displayed, contact NxStage Technical Support to arrange for a replacement PureFlow and a Return Authorization number to return the PureFlow to NxStage.

B. Check the Ultraviolet (UV) Light Preventive Maintenance (PM) Status 1. Starting from STANDBY, press and hold the down arrow until system

displays the USER MAINTENANCE mode.

2. Press the down arrow until PM Info is displayed in the USER MAINTENANCE widow. In most cases pressing the down arrow twice displays the PM Info option.

3. Press GO to select the PM Info option. This displays the first screen of the PM Info selection, including the UV Light PM status information: Due in XX batches.

Note: If the time remaining is less than 156 batches (equivalent to one year life at 3 batches per week), contact NxStage Technical Support for a replacement control unit.

You can exit the PM Info mode at anytime by pressing and holding the STOP button until the PureFlow SL control unit goes into the Electronic/SW Test mode. Once the self test has been successfully completed, the PureFlow SL control unit automatically returns to STANDBY mode.

Note: To display the Conductivity Sensor Preventive Maintenance information, continue to Step 4.


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C. Check the Conductivity Sensor Preventive Maintenance (PM) 4. Press the down arrow to view the next screen of the PM Info selection,

which displays the Condo Sensor PM status information: Due in XX days.

Note: If the conductivity sensor Preventive Maintenance is due in less than 300 days, perform the “D. Complete the CPM-001 Procedure” in the next section.

5. Press the down arrow again to view the next screen of PM Info selection which will display the Last Condo PM date: Completed on MM/DD/YY (user).

You can navigate between screens in PM Info mode by pressing the UP or DOWN ARROW.

6. When you have finished reviewing the PM Status information, press and hold the STOP button until the PureFlow SL control unit goes into Electronics/SW Self Test mode. Once the self test has been successfully completed, the PureFlow SL control unit automatically returns to STANDBY mode.

D. Complete the CPM-001 Procedure If the conductivity sensor Preventive Maintenance (PM) is due in less than 300 days, complete these steps to perform the CPM-001 procedure.

Note: This procedure is also used in response to the following alerts from your PureFlow SL:

Caution 10 (C10): PM Due in XX days

– OR –

Alarm 79 (A79): Maintenance required


24 NC3927 Rev A 2012/02/29

Complete the following steps to perform the CPM-001 procedure:

1. Make sure the following conditions are met:

• You have a complete CPM-001 Kit. Make sure the expiration date has not passed. This kit is contained within the NX0730 PureFlow SL Patient Redeployment Kit.

• A control unit drain line is connected and positioned in a drain.

• The PureFlow SL is in STANDBY or CONDO PM mode.

• The conductivity standard solution is at room temperature.

2. Starting from STANDBY, press and hold the down arrow until the system displays User Maintenance.

3. Press the down arrow until Condo Sensor PM is displayed in User Maintenance.

4. Press GO to enter CONDO PM mode, which displays on the control panel.

5. Open the box, remove the zip lock bag, and remove the syringe with attached tubing and connector from the zip lock bag.

6. Open the plastic bottle containing the conductivity standard solution and remove the protective seal.

7. Remove the protective cap at the end of the syringe tubing and ensure that the white clamp on the tubing is open.

8. Insert the end of the syringe tubing into the conductivity standard solution.


NC3927 Rev A 2012/02/29 25

9. Fill the syringe with 60 ml of the conductivity standard solution by pulling the syringe plunger back.

Note: The fluid should reach the 60 ml line on the syringe.

10. Connect the syringe tubing to the orange conductivity sensor connector on the control unit.

11. Press GO. The system displays the message: Condo PM Inject Fluid.

12. Hold the syringe with the plunger end up. Inject the fluid into the control unit conductivity sensor. This position prevents air from entering into the control unit.

13. Close the white clamp on the syringe tubing and leave the tubing connected to the connectivity sensor connector.

14. Press GO. The following message appears on the control panel display: Condo PM TR: 45:00 Testing……

When the system has finished performing the preventive maintenance test and the test is successful, the control panel displays:

Condo PM Passed Press Go to Continue

If the test was successful, then the next preventive maintenance test of the conductivity sensor will be due in one year.

15. Press GO to return to STANDBY and disconnect the syringe connector from the control unit.


26 NC3927 Rev A 2012/02/29

16. If the system successfully completed the preventive maintenance test, continue to the next section “E. Disinfect the PureFlow Conductivity Sensor.”

Note: Reserve the CPM-001 syringe with tubing and connector for repeat testing or to disinfect the conductivity sensor.

If the system could not successfully complete the preventive maintenance test, the control panel display reads:

Condo PM Axx Error Message

To continue with the Conductivity Preventive Maintenance testing:

1. Disconnect the syringe connector from the control unit.

2. Open the white clamp on the syringe tubing.

3. Follow the corrective actions for the alarm displayed:

Alarm 83: • Press STOP to acknowledge the alarm. • Adjust the room temperature to be within 60° to 100° Fahrenheit. • Let the PureFlow SL and the test kit adjust for one hour. • Press GO to repeat the test, starting with Step 8 on page 24. • If the test fails for the second time, contact NxStage Technical Support.

Alarm 84 or 85: • Press STOP to acknowledge the alarm. • Press GO to repeat the test, starting with Step 8 on page 24. • If the test fails for a second time, contact NxStage Technical Support.

Alarm 86: • Press STOP to acknowledge the alarm. • Press GO to repeat the test, starting with Step 8 on page 24. • If the test fails for the second time, contact NxStage Technical Support

Alarm 87: • Press STOP to acknowledge the alarm. • Press GO to repeat the test, starting with Step 8 on page 24. • If the test is not successful for the second time, contact NxStage

Technical Support.


NC3927 Rev A 2012/02/29 27

E. Disinfect the PureFlow Conductivity Sensor 1. Rinse the interior and exterior of the CPM-001 syringe with attached tubing

and connector with water prior to using to disinfect the conductivity sensor.

2. Connect a drain line to the drain line connection on the rear of the control unit and run the drain line to an appropriate fluid drain.

3. Using the CPM-001 syringe with attached tubing and connector fill the syringe with 30 ml of the prepared 1:10 bleach solution.

4. Connect the CPM-001 connector to the conductivity sensor connector on the control unit (orange connector).

5. Push the bleach solution into the conductivity sensor connector.

6. Let the bleach solution stay in the conductivity sensor connector for ten minutes.


28 NC3927 Rev A 2012/02/29

7. Disconnect the CPM-001, rinse thoroughly with tap water, and refill with 60 ml of tap water.

8. Connect the CPM-001 connector the conductivity sensor connector on the control unit.

9. Push the tap water into the conductivity sensor connector.

10. Disconnect the CPM-001 connector and refill with 30 ml of tap water. Then push the tap water into the conductivity sensor connector. This ensures that the bleach solution is outside of the PureFlow SL and into the drain line.

Note: Residual chlorine testing of the conductivity line is not required: 1) multiple check valves contained in the lines; 2) uni-directional pump flow prevents reverse flow during use; and 3) connection is upstream to a single-use disposable.

11. Disconnect the CPM-001 conductivity sensor connector and discard.

F. Disinfect the PureFlow SL Drain Line 1. Attach a recirculation connector (female-female adapter) to a 30 ml syringe

to create a recirculation adapter (RA).

2. Fill the RA with 30 ml of the prepared 1:10 bleach solution.

3. Connect the RA to the control unit waste line connector (yellow connector).

4. Push the bleach solution into the waste line connector. A drain line must be connected to the control unit and positioned in the drain.

5. Let the solution stay in the drain line for ten minutes.


NC3927 Rev A 2012/02/29 29

6. Disconnect the RA from the waste line connector and repeat Steps 2 through 5. A total of 60 ml of the bleach solution is used to flush the drain line.

7. Disconnect the RA. Thoroughly rinse with tap water. Refill with 30 ml of tap water.

8. Connect the RA to the control unit waste line connector.

9. Push the tap water into the waste line connector on the control unit.

10. Repeat Steps 7 through 9 two more times. This ensures that the bleach solution is outside of the PureFlow SL and into the drain line.

Note: Residual chlorine testing of the conductivity line is not required: 1) multiple check valves contained in the lines; 2) uni-directional pump flow prevents reverse flow during use; and 3) connection is upstream to a single-use disposable.

11. Disconnect the RA from the control unit waste line connector.

12. Detach the drain line attached to the rear of the control unit.

G. Decontaminate the PureFlow SL Follow the “I. Decontaminate Exterior Surfaces of Equipment and Accessories ” instructions on page 16.


30 NC3927 Rev A 2012/02/29

H. Replace the PureFlow SL Air Filter Media 1. Remove the air filter plastic housing and filter media from PureFlow SL

and discard the filter media.

Note: The air filter guard attached to PureFlow SL must remain attached to PureFlow SL. Do not loosen or remove the four guard screws.

2. Replace the filter media, included with the NX0730 PureFlow SL Patient Redeployment Kit.

3. Snap the air filter plastic housing and new filter media assembly onto the existing PureFlow SL guard.

NC3927 Rev A 2012/02/29 31

Redeployment Forms This section includes the forms needed to make sure that equipment is prepared for redeployment.

• Redeployment Training Documentation Form – Use this form to document learner training and competency.

• Equipment and Accessories Form – Use this form to make sure that all accessories are present, and order replacement accessories from Customer Service as required.

• Redeployment Documentation Form – Complete this form to record the serial number, if any, for each piece of equipment; and completion of equipment and accessory redeployment steps.

• Patient Equipment Log Form – Use this form to maintain a record of patient equipment by serial number.

Redeployment Forms Equipment Redeployment Instructions

32 NC3927 Rev A 2012/02/29

Redeployment Training Documentation Form Use this form to document learner training and competency for the procedures listed.

Procedures (refer to “* * Always use universal precautions. Redeployment Procedures” on page 15)

Instruction provided: Trainer’s initials/date

Learner understands / demonstrates procedures correctly: Trainer’s Initials/date

• Review Equipment Redeployment Instructions (NC3927)

Cycler

• Respond to Cycler Caution 71

• Decontaminate returned equipment and accessory exterior surfaces

• Disinfect the interior surface of the Cycler and clean blood leak detector

• Adjust System Settings to default values

Cycler Base, Fluid Detection Sensor, and Warmer


• Test leak detector sensor alarm

PureFlow SL

• Respond to Caution 2 and Alarm 853

• Check ultraviolet light preventive maintenance status

• Check conductivity sensor preventive maintenance status

• Perform CPM-001 procedure

• Disinfect the conductivity sensor

• Disinfect the drain line


• Replace the air filter media

NxStage Equipment Redeployment Training is Complete Instructor Signature: Date:

Learner Signature: Date:

Equipment Redeployment Instructions Redeployment Forms

NC3927 Rev A 2012/02/29 33

Equipment and Accessories Form Use this form to:

• Inspect returned equipment to ensure that all accessories are present. • Order replacement accessories from Customer Service as required.

Note: Based upon your center contract, there may be a charge for accessories.

Equipment / Accessories Check if Present Reorder Number

System One Cycler with Computer (Jewel Box or ConNxBox attached) NX1000-1

Filter holder NX0593

12’ power cord NX0792

Cycler Base, including: NX0642

Fluid Detection Sensor * NX0664

PureFlow SL cabinet NX2000-2

PureFlow SL wheeled base NX2000-3

PureFlow SL control unit NX2000-1

Interconnect power cord 86557300

12’ power cord NC1176

Saline hook NX0429

Air filter fan cover NC3823

USB cable NX0509

ComfortMate Fluid Warmer FW-200

IV pole used with table top stand NX0248-02

Table top stand, including: NX0248-01

4-hanger top for IV pole* 228

Screw (spade head) to attach hanger to pole* NC0384

Screw (2”) to attach pole to stand * NC1292

Screw (thumb screw) to attach table top stand to Cycler * NC0426

0.5 meter interconnect power cord for FW-200* 86557030

Express Fluid Warmer FW-300

Express Fluid Warmer Accessory Kit, including: FW-300-1

Bag cover * NX0599

IV pole* NX0485

Interconnect power cord* 86557030

Top mount* NX0484

Bottom mount* NX0600

Screw (thumb screw) to attach Bottom Mount to Cycler* NC0426

* This item is included with the companion product as listed, but may be ordered separately using the appropriate reorder number, if required.

Redeployment Forms Equipment Redeployment Instructions

34 NC3927 Rev A 2012/02/29

Cycler Serial Number: ____________

Signature and date of person completing steps: ____________________________ / ______________

Redeployment Steps Completed

1. Equipment and accessories inspected.

2. Upon Power On: the Control Panel Flashes 888s.

3. Upon Power On: Yellow Caution # 71 not displayed.

4. Equipment exterior surfaces and accessories decontaminated.

5. Cycler interior surface disinfected, and blood leak detector and mirror cleaned.

6. System Settings set to CAR-170 default values.

Cycler Base and Fluid Detection Sensor No Serial Number



1. Inspect equipment and accessories.

2. Sensor alarms appropriately when battery inserted and when the sensor’s metal bars are contacted with moist cloth.


Express Fluid Warmer Serial Number: ___________




2. Upon power cord connection, the Express Fluid Warmer’s Comfort status lights flash red, yellow then green and the standby and hot surface indicators come on then go off. An alarm sounds, all lights go out and the standby light remains lit.

3. Equipment and accessories exterior surfaces decontaminated.

ComfortMate Serial Number: ___________ Table Top Stand, No Serial Number.




2. Upon Power On, the warmer’s control panel lights flash, an alarm sounds and the green light on the front of the warmer remains lit.


PureFlow SL Control Unit Serial Number: _________




2. Upon Power On: the control panel LEDs flash red, green, yellow and the panel displays NxStage Medical Inc. and software version.

3. Upon Power On: Caution 2 or Alarm 853 are not displayed.

4. Preventive Maintenance (PM) status for the Ultraviolet (UV) light is greater than 156 batches.

5. Conductivity sensor PM is due in greater than 300 days or CPM-001 is completed.

6. Conductivity sensor disinfected.

7. Drain line disinfected.

8. Equipment and accessories exterior surfaces decontaminated.

9. Air filter media replaced.

PureFlow SL Cabinet Serial Number: ___________





Redeployment Documentation Form Use this form to document completion of equipment and accessory redeployment steps.

Equipment Redeployment Instructions Redeployment Forms

NC3927 Rev A 2012/02/29 35

Patient Equipment Log Form Use this form to maintain a record of patient equipment by serial number. Patient Name: __________________________________________________________ Therapy Start Date: __________________ Therapy End Date: __________________

Cycler Serial #

Date Received

Date Returned to: Date Cycler Redeploy Procedures Completed

Date Cycler Redeployed

Cycler Redeployed to (Patient) Center NxStage

__________ ________ ________ ________ _____________________ ___________ _________________

__________ ________ ________ ________ _____________________ ___________ _________________

PureFlow SL Control

Unit Serial # Date

Received

Date Returned to: Date Control Unit

Redeploy Procedures Completed

Date Control Unit Redeployed

Control Unit Redeployed to

(Patient) Center NxStage

__________ ________ ________ ________ ____________________ ___________ _________________

__________ ________ ________ ________ ____________________ ____________ _________________

PureFlow SL Cabinet

Serial # Date

Received

Date Returned to: Date Cabinet Redeploy Procedures Completed

Date Cabinet

Redeployed

Cabinet Redeployed to


__________ ________ ________ ________ _____________________ ___________ _________________

__________ ________ ________ ________ _____________________ ___________ _________________

ComfortMate Warmer Serial #

Date Received

Date Returned to: Date Warmer

Redeploy Procedures Completed

Date Warmer

Redeployed

Warmer Redeployed to


__________ ________ ________ ________ ____________________ ___________ _________________

__________ ________ ________ ________ ____________________ __________ _________________

Express Fluid

Warmer Serial #

Date Received

Date Returned to: Date Warmer Redeploy Procedures

Completed

Date Warmer

Redeployed

Warmer Redeployed to


__________ ________ ________ ________ ____________________ ___________ _________________

__________ ________ ________ ________ ____________________ __________ _________________

Other Equipment

Date Received

Date Returned to: Date Redeploy Procedures Completed

Date Redeployed

Redeployed to (Patient) Center NxStage

__________ ________ ________ ________ _____________________ ___________ _________________

__________ ________ ________ ________ _____________________ __________ _________________

NC3927 Rev A 2012/02/29

NxStage Customer Service Center (United States only)

Tel: 1-866-NXSTAGE (1-866-697-8243)

Fax: 1-978-687-4809

Email: [email protected]

NxStage Medical, Inc. 439 South Union Street, 5th Floor Lawrence, MA 01843 USA

mailto:[email protected]�

equipment redeployment...

Documents