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"

Reference Notes for NxStage in the Home Hemodialysis Environment

Training/reference

material. Not intended to replace User's Guide.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A

4 )

"

Reference Notes for NxStage in the Home Hemodialysis Environment

Training/reference

material. Not intended to replace User's Guide.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A

.\

.'J

,I

Contents

Training/reference

Cartridge Diagram Set-up Initiate Prime Manage Treatment Settings Prepare for Patient Connections Launch Treatment Monitor Treatment Treatment: Common Procedures Temporary Disconnection End Treatment and Returning Blood Troubleshooting NxStage Customer Service
material. Not intended to replace User's Guide.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A

4.1

"

Reference Notes for NxStage in the Home Hemodialysis Environment

Training/reference

material. Not intended to replace User's Guide.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A

.\

.'J

,I

Contents

Training/reference

Cartridge Diagram Set-up Initiate Prime Manage Treatment Settings Prepare for Patient Connections Launch Treatment Monitor Treatment Treatment: Common Procedures Temporary Disconnection End Treatment and Returning Blood Troubleshooting NxStage Customer Service
material. Not intended to replace User's Guide.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A

,)

CAR-160
Waste line
(yellow clamp)

Tberapy fluid
inl

Arterial patient line (red clamp)

(green clamp)

Venous
patient lin", ~

(blue clamp) .~

(\~

h-'"

~"J .;,....... .,,-.,


"

. ~

~'.1- .;.:

'j

! .., 1"-::' ~
_
I I

'J
!

~~ \

,.:..::',a

Saline lin (white clamp)

t
Post-filter port

Arterial pressure pod

(blue clamp)
Training/reference material. Not intended to replace User's Guide.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A \

I ,. .

Set-up
Wash Hands Gather Supplies Hang bags if needed Prepare the Cycler
Open door Turn ON the power to both the cycler and fluid warmer. Pure flow will be on. Tighten patient lines on priming spike, then lift priming spike from cartridge Insert cartridge (press tubing in to ~ squares- air detectors) Shut door Cartridge, saline, syringes, fluid and access supplies

"Open the Door turn on the lights" Pure flow never gets turned off.

Training/reference

material. Not intended to replace User's Guide.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A \

Initiate Prime and Alarm Tests


Prime Cartridge:
Spike saline bag Hang saline bag from IV pole Attach access pressure pod Press ADD FLUID This starts the 15 minute cycle

Prime Fluid Warmer: For Bags Only


Insert warmer disposable into warmer and shut door Connect Therapy Fluid MLA lines to DIALYSATE bags. Break frangibles/cones Prime and clamp unused MLA lines Prime the warmer air trap and then clamp Clamp warmer outlet Put warmer knob to 12 o'clock position

Do not need to do this if using the Pure Flow cabinet. 6 lines

Top Front (1:00) or what is comfortable

Prepare drain line extension (Beginning of the week tie tube on IV pole on back) if using bags.
Training/reference material. Not intended to replace User's Guide.

Do not need to do this if using PureFlow cabinet.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A
\

Initiate Prime and Alarms Test


Complete Alarms Test
After 18 minutes see all "8's", then press MUTE See display test (1-4, a-h, 9-1), then press MUTE See 23.0/000 - Do not press STOP If you put needles in here, then prime Venous needle. Attach heparin syringe. Inject heparin and clamp. Prime Arterial line and clamp.

REMOVE AIR FROM THE BLOOD CIRCUIT:


See 23.0 and "000" display Snap/tap arterial patient line to remove air Invert filter (blue side up) AND venous filter line up, tap to remove air from filter Put filter in filter holder with venous filter cap port upright, vent post-filter cap port and clamp Snap/tap venous patient line to remove air Recheck to be sure air is removed from patient lines Press STOP

This is the Red/ white/ blue to get air out of lines. Red line first, filter second, blue line third.

Training/reference

material. Not intended to replace User's Guide.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A \

..

Manage Treatment Settings


Enter Treatment Parameters Press MEASURING CUP, for volume display (VOL)
Green -Verify target volume of DIALYSATE fluid Yellow -Enter target volume of ultrafiltration (ex. 1.0L) Red display will read: Vol. After 10 seconds, screen will go back to the rate display. How Much Screen 15~ Green- Your Fluid prescription. Yellow -This is your weight you want to remove.

Press MEASURING CUP (if needed), for rate display


Red -Verify blood flow rate (ex. 250 ml/min) , Yellow -Enter ultrafiltration rate (ex. 1.0Uhr) Green - Enter DIALYSATE flow rate (ex. 3.0 Llhr) (Will do this step later when Blood Flow achieved)

How Fast Screen Red -This is the starting Blood flow. 2.00 Yellow-This is how fast Fluid is removed from you per hour.

,g

Training/reference

material. Not intended to replace User's Guide.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A
\

Prepare for Patient Connections


Close all 8 clamps. (2 red, 2 blue, 2 yellow, 1 green and white) -. Prime saline "T" (~9-~tfamp) and clamp.
Using pure flow, press GO and prime one port on the chicken foot. Clamp small green clamp on line.

Attach saline line (white) to saline "T" (.a:ea Whl~ clamp) DO NOT UNCLAMP Connect cartridge therapy fluid inlet (green) to warmer outlet or Pure Flow cabinet (green) and unclamp. Clamp and disconnect drain line (yellow) and connect to drain line extension or Pure Flow cabinet on front, then unclamp. Wash Hands Prepare the vascular access
Training/reference

~6D

vn~

If already done, skip this step.

material. Not intended to replace User's Guide.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A
(

wltA U&~6up
Launch Treatment
Connect to Patient Access:
Clamp and disconnect red and blue patient lines from the priming spike. Connect to patient access and unclamp

Verify:

v0~-\1-e...
white clamps)

1. Saline line is double clamped ~and

2. Dialysate fluid lines (green clamps) are unclarnped And if using bags: The unused MLA lines are clamped The warmer is turned to the 12 o'clock position The warmer air trap vent is clamped The warmer outlet and fluid inlet line are unclamped 3. Patient lines (red and blue) are unclarnped 4. The waste line and the drain line extension or to Pure Flow cabinet are unclarnped.

Start therapy
Press GO on pure flow control panel (If not done) Press TREATMENT (see 7, then 8 in yellow caution window). Increase to prescribed blood flow and then Dialysate.
Training/reference material. Not intended to replace User's Guide.

Increase dialysate (GREEN arrow) until #3 in yellow display


\.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A
(

Monitor Treatment
Document on flow sheet as directed Monitor:
Access pressure (i.e. 50 to 200) Venous pressure (i.e. <250-300) Effluent pressure (close to venous pressure) Ultrafiltration volume (actual fluid removed) Rates: therapy fluid, ultrafiltration, blood flow Ensure patient lines are visible Vital signs and response to therapy. DIALYSATE bags draining equally Saline line is primed and double clamped (red and white clamps) Warmer air trap full, vent if necessary Arterial pressure pod full - pressures within range Post-filter cap for air (if so, extract air with a syringe, hold the syringe upright and inject any blood back through the post filter cap port then clamp the post filter cap port securely). Promptly respond to all Alarms and Cautions

Access max: 260 Venous max: 300 Effluent: close to venous pressure

Training/reference

material. Not intended to replace User's Guide.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A
I

10

Treatment: Common Procedures


Saline Bolus:
Note volume of saline in bag Open saline line white clamps) and allow desired amount of saline to infuse, then reclamp Evaluate need to add saline bolus volume to fluid balance calculations

(~'rrfu

Bolus/Flush Filter to Check for Clotting:

h'I{-e...

Note volume of saline, open saline line (~ and white clamps) and occlude arterial patient line proximal to saline "T" . When complete, remove occlusion to arterial patient line and reclamp saline line (j:et1 and white clamp) vJh~e... Add saline bolus volume to fluid balance calculations if not previously added in to the total UF goal at the beginning of treatment.

Training/reference

material. Not intended to replace User's Guide.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A

11

Temporary Disconnection
Recirculation of the Blood Circuit Complete rinseback, ending with the arterial patient line (red clamp) connected to the priming spike (red port). Clamp and disconnect venous patient line (blue clamp) from the access, attach it to the priming spike (blue port), then unclamp. Press TREATMENT and set therapy fluid at 0.1 L/hr, ultrafiltration rate to zero and increase blood flow rate to 250-350 ml/min to create venous pressure of 40 or higher.
Low venous pressure alarms may occur. If so, reset alarm and increase blood flow rate to increase venous pressure.
Training/reference material. Not intended to replace User's Guide.

i.e. difficulty with access

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A

12

End of Treatment and Return Blood (Routine)


"000" will appear in yellow caution window Treatment targets have been met and blood pump continues to run Make sure enough saline is available to rinseback the blood. (300-500ml) Press STOP to stop blood pump and move the cycler into rinseback mode then press STOP on Pure Flow to pause batch. Clamp and disconnect arterial patient line (red clamp) from patient and reconnect to red port on the priming spike, and unclamp. Press ADD FLUID to rinseback blood (see countdown to zero and will stop automatically). Clamp and disconnect the venous patient line (blue clamp) from the patient and reconnect to the blue port on the priming spike. Close Green (non reopening) clamp on Pure Flow line and clamp small green clamp.
Training/reference material. Not intended to replace User's Guide.

Draw up flushes in the syringes that are hanging from the priming spike.

Attach syringe to patients arterial line and flush.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A

13

End of Treatment and Return the Blood (Operator End)


Press and hold STOP for 2 seconds to see "000" in yellow display (therapy fluid and UF rates go to zero, but blood pump stays on) Make sure enough saline is available to rinseback the blood. (300-500ml) Press STOP to stop blood pump. Press STOP on Pure Flow to pause batch. Clamp and disconnect arterial patient line (red clamp) from patient and reconnect to red port on the priming spike, and unclamp. Press ADD FLUID to rinseback blood (see countdown to zero and will stop automatically). Clamp and disconnect the venous patient line (blue clamp) from the patient and reconnect to the blue port on the priming spike. Close Green (non reopening) clamp on Pure Flow line and clamp small green clamp.
Training/reference material. Not intended to replace User's Guide.

Draw up flushes in the syringes that are hanging from the priming spike.

Attach syringe to patients arterial line and flush.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A

14

Return the Blood (Rinseback) - Alternate


To be used when the rinseback is unplanned Make sure enough saline is available to rinseback the blood. (300-500ml) Press STOP Clamp and disconnect arterial patient line (red clamp) and reconnect to priming spike (red port), and unclamp. Press TREATMENT You may decrease blood flow rate to 200ml/min
-You may need to decrease therapy fluid rate in order to decrease blood flow rate.

i.e. still in treatment mode and there is time to move the arterial patient line.

A low venous pressure #20, #21 may occur with the blood pump rate turned down).

When venous patient line (blue clamp) is clear, press STOP. Clamp and disconnect venous patient line (blue clamp) from patient and reconnect to the blue port on the priming spike.
Training/reference material. Not intended to replace User's Guide.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A

15

Return the Blood (Rinseback) - Alternate


To be used in an Emergency Make sure enough saline is available to rinseback the blood. (300-500ml) Open saline clamps on priming line (ensure flow), clamp the arterial patient line proximal to saline "T", and allow saline to infuse and return the patient's blood. You may decrease blood flow rate to 200ml/min
-You may need to decrease therapy fluid rate in order to decrease blood flow rate.

(i.e. prolonged troubleshooting or unable to move arterial patient line)

A low venous pressure #20, #21 may occur with the blood pump rate turned down).

When venous patient line (blue clamp) is clear, press STOP. Clamp and disconnect venous patient line (blue clamp) from patient and reconnect to the blue port on the priming spike.
Training/reference material. Not intended to replace User's Guide.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A

16

Troubleshooting
Press MUTE Identify condition and follow instructions to correct the problem Press STOP Press TREATMENT to continue

Training/reference

material. Not intended to replace User's Guide.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A

17

Commonly Encountered Alarms


Alarm # 24 Check Arterial Access: Access Pressure at Low Limit

Cause
Arterial line kinked or clamped OR Access pressure pod error

How to Correct
Check arterial access or unkink or unclamp red line OR See Alarm Chart (C-6) Follow steps for resetting access pressure pod membrane. See Alarm Chart (C-6) Follow steps for resetting access pressure pod membrane. Check arterial needle, unkink or unclamp red line, check blue line, check for clotted filter with saline bolus.

25 20 21-

Access Pod Error:

Reset Access Pressure Pod

Access pressure pod connection kinked, OR clamped, leaking, or not connected OR Access pressure pod error Arterial line kinked or clamped OR venous line disconnected, OR clotted filter

Check Blood Circuit:

Venous Pressure Low Check Blood Circuit:

Venous Pressure Low Decreasing


Training/reference material. Not intended to replace User's Guide.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A

18

l.'

Commonly Encountered Alarms


Alarm # 11
- Check for Arterial air

Cause
Air entering blood circuit, OR poor flow through arterial access OR Loose connection at arterial access Air entering blood circuit, OR Arterial connection loose OR Arterial access dislodged or disconnected Drain line occluded, OR therapy line occluded, OR clotted filter

How to Correct
Follow steps for arterial air recovery on alarm chart (C-3)

10 -

Check for venous air

Follow steps for venous air removal on alarm chart (C-7)

37 ,38 35 Pressure High

High balance

chamber pressure Check Waste Line Empty Therapy Fluid Bags OR Loose Therapy Fluid connection OR Warmer disposable air trap full of air

Check for closed clamps or cap on drain line, check for closed clamps on therapy fluid line, check for kinked lines on dialyzer.

14 -

Check Fluid Line

Inlet: Air Detected in Fluid Line Inlet


Training/reference

Gently pull on the inlet and outlet lines of the Fluid warmer bag.

material. Not intended to replace User's Guide.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A

19

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NxStage Customer Service


1-866-NXSTAGE (1-866-697 -8243) 24/7 Technical/clinical support

Training/reference

material. Not intended to replace User's Guide.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A

20

NxStage Yellow Caution Alarm Codes


Display
000
1 2 3 4
5

Cause
End of Treatment / Rinseback Infusing Fluid Bolus Fluid Balance System Check Parameter Limit Exceeded Blood Pump Off Target Volume Reached Blood Circulation Only Alarms Overridden Pressure Limits Not Locked Auto High Pressure Recovery Air Recovery Underway Air Detected in Fluid Line Inlel Venous Pressure Low Venous Pressure Decreasing Effluent Pressure Decreasing Access Pressure Decreasing to Low Limit Access Pod Error/Rest Access Pressure Pod Filter Pressure Error/Reset Filter Pressure Pod Venous Pressure Approaching High Alarm Limit Check Filter for Clotting Venous Pressure Increasing Power Failure Fluid Cooldown Underway Continue Treatment/Fluid Cooldown Complete Cartridge Life Exceeded Preventive Maintenance Due Treatment Complete Reconfigure Cartridge Line Tap Filter to Remove Air (Optional) Pressure Offset Rezeroing Needed Correct Settings Conflict Service Mode Activated

Action
None None None Set a Value Too Low or Too High Press Treatment/Add Fluid to Continue UF Volume Target Reached Fluid Removal Rates Set to Zero Temporary Override of Alarms (Monitor until Green) Pump Rate Change (Monitor until Green) Alarm Reset After Red Alarm (None) If No Air Noted Press Treatment to Continue/If Air Remove
Empty Therapy Fluid Bags/Loose Connections/Warmer Full of Air/Air in Tubing Arterial Flow Problem KCONenous Line Leak or Disconnection/Clotted Filter Arterial Flow Problem KCONenous Line Leak or Disconnection/Clotted Filter Arterial Flow Problem KCO/Clotted Filter/Filtration Fraction Too High Arterial KCO/Clotted Filter/Filtration Fraction Too High/Effluent Line KCO

6 7 8
9

12 14 20 21 23 24 25 27 30 31 32 40 51 52 70 71 72 80 81 88 93 999

Access Pressure Connection KCO, Leaking or Not Connected Filter Pressure Connection KCO, Leaking or Not Connected Venous Flow Problem KCONenous Needle Infiltration Clotted Filter Venous Flow Problem KCONenous Need Infiltration or Clotted If Power Restored/Press Treatment/Add Fluid to Continue Red Alarm-50 Cleared Fluid <38.5 C after Red Alarm-50 Press Treatment to Resume Cartridge TimeNolume Limit Exceeded/End Tx Replace Cartridge Complete Treatment and Schedule Maintenance User Opened Door at End of Treatment Operator Parameter #25 set to 1/Press Add Fluid to Continue Filter May Be Checked For Air/Priming Procedure Underway
Cycler was Powered Up with Door Closed and/or a Cartridge Installed Parameter Set to a Value Which Conflicts with Previous Value/Re-Enter Values

DO NOT INITIATE TREATMENT/CALL NxSTAGE


Handbook TabS Alarm Codes Page 2 of 2

2009 DaVita Inc. All rights reserved.

Proprietary and Confidential - For internal use only. May not be copied or distributed without written permission from DaVita Inc.

Description
Alarm Test Passed Venous Air Arterial Air Check Fluid Line Inlet (Air Detected) Venous Pressure Low (Blood Circuit) Venous Pressure Decreasing (Blood Circuit) Effluent Pressure Low (Blood Circuit) Effluent Pressure Decreasing (Blood Circuit) Access Pressure at Low Limit Venous Pressure High Clotting Detected High TMP: TMP >500mmHg Waste Line Pressure High Fluid Balance System Failure High Balance Chamber Pressure Therapy Inlet Occlusion Failed Power Recovery Fluid Temperature High Blood Detected in Effluent Line Failed Blood Leak Detector Waste Line Check Failure Failed Alarm Test UF Occlusion Test Failure Pressure Offset Rezeroing Needed Pressure Offset Rezeroing Failed Fluid Circuit Test Failure Cartridge Leak Probable System Alarms Blood Leak High
2009 DaVita Inc. All rights reserved.

Action
None Required Assess For Air (Pt to blood pump) Check Connections/Poor Flow Check Priming Fluid/Kinked Tubing KCO in Pt Arterial Line/Poor Arterial Flow/Clotted Filter KCO in Pt Arterial Line/Poor Arterial Flow/Clotted Filter
Arterial Flow Low/KCO Effluent Line/Filtration Fraction Too High/Clotted Filter Arterial Flow Low/KCO Effluent Line/Filtration Fraction Too High/Clotted Filter Assess KCO in Pt line/Poor Arterial Flow/Arterial Pressure Pod error

Assess KCO in Venous LineNenous Line Clotted Check Filter for Clotting/Clotted Filter
Check Filter/KCO Venous Filter Line/Clotting Venous Header Waste Line occluded/Waste Bag Full/Low effluent pressure-Low Arterial Flow

TERMINATE TREATMENT
KCO in Circuit line/Clotted Filter/Air or Fluid in Balancing System Check Fluid Inlet/Air or Fluid in Balancing System

Perform Manual Rinseback If System Not Clotted Warmer Set Too High/Therapy Fluid Bags too Warm Filter Membrane Leak/Air in Effluent/Filtration Fraction Too High Blood Leak Detector Lens and/or Mirror Not Clean Cartridge Not Properly Loaded Improper Priming/Faulty Cartridge/Cycler Malfunction Cartridge Not Properly Loaded Blocked/Kinked Fluid Lines/Pressure Offset Error Cycler Unable to Adjust Variable Pressure Offset on Start up Check Cartridge for Leaks/Malfunction of Fluid Balancing System Cartridge Integrity Compromised System Error/lnternal Communication Error
Indicates Blood Leak Detector Malfunction/Fluid Has Interfered with Blood Leak

Handbook TabS Alarm Codes Page 1 of 2

Proprietary and Confidential - For internal use only. May not be copied or distributed without written permission from DaVita Inc.

4.1

"

Reference Notes for NxStage in the Home Hemodialysis Environment

Training/reference

material. Not intended to replace User's Guide.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A

.\

.'J

,I

Contents

Training/reference

Cartridge Diagram Set-up Initiate Prime Manage Treatment Settings Prepare for Patient Connections Launch Treatment Monitor Treatment Treatment: Common Procedures Temporary Disconnection End Treatment and Returning Blood Troubleshooting NxStage Customer Service
material. Not intended to replace User's Guide.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A

,)

CAR-160
Waste line
(yellow clamp)

Tberapy fluid
inl

Arterial patient line (red clamp)

(green clamp)

Venous
patient lin", ~

(blue clamp) .~

(\~

h-'"

~"J .;,....... .,,-.,


"

. ~

~'.1- .;.:

'j

! .., 1"-::' ~
_
I I

'J
!

~~ \

,.:..::',a

Saline lin (white clamp)

t
Post-filter port

Arterial pressure pod

(blue clamp)
Training/reference material. Not intended to replace User's Guide.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A \

I ,.

Set-up
Wash Hands Gather Supplies Hang bags if needed Prepare the Cycler
Open door Turn ON the power to both the cycler and fluid warmer. Pure flow will be on. Tighten patient lines on priming spike, then lift priming spike from cartridge Insert cartridge (press tubing in to ~ squares- air detectors) Shut door Cartridge, saline, syringes, fluid and access supplies

"Open the Door turn on the lights" Pure flow never gets turned off.

Training/reference

material. Not intended to replace User's Guide.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A \

Initiate Prime and Alarm Tests


Prime Cartridge:
Spike saline bag Hang saline bag from IV pole Attach access pressure pod Press ADD FLUID This starts the 15 minute cycle

Prime Fluid Warmer: For Bags Only


Insert warmer disposable into warmer and shut door Connect Therapy Fluid MLA lines to DIALYSATE bags. Break frangibles/cones Prime and clamp unused MLA lines Prime the warmer air trap and then clamp Clamp warmer outlet Put warmer knob to 12 o'clock position

Do not need to do this if using the Pure Flow cabinet. 6 lines

Top Front (1 :00) or what is comfortable

Prepare drain line extension (Beginning of the week tie tube on IV pole on back) if using bags.
Training/reference material. Not intended to replace User's Guide.

Do not need to do this if using PureFlow cabinet.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A
\

Initiate Prime and Alarms Test


Complete Alarms Test
After 18 minutes see all "8's", then press MUTE See display test (1-4, a-h, 9-1), then press MUTE See 23.0/000 - Do not press STOP If you put needles in here, then prime Venous needle. Attach heparin syringe. Inject heparin and clamp. Prime Arterial line and clamp.

REMOVE AIR FROM THE BLOOD CIRCUIT:


See 23.0 and "000" display Snap/tap arterial patient line to remove air Invert filter (blue side up) AND venous filter line up, tap to remove air from filter Put filter in filter holder with venous filter cap port upright, vent post-filter cap port and clamp Snap/tap venous patient line to remove air Recheck to be sure air is removed from patient lines Press STOP

This is the Red/ white/ blue to get air out of lines. Red line first, filter second, blue line third.

Training/reference

material. Not intended to replace User's Guide.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A \

..

Manage Treatment Settings


Enter Treatment Parameters Press MEASURING CUP, for volume display (VOL)
Green -Verify target volume of DIALYSATE fluid Yellow -Enter target volume of ultrafiltration (ex. 1.0L) Red display will read: Vol. After 10 seconds, screen will go back to the rate display. How Much Screen 15~ Green- Your Fluid prescription. Yellow -This is your weight you want to remove.

Press MEASURING CUP (if needed), for rate display


Red -Verify blood flow rate (ex. 250 ml/min) , Yellow -Enter ultrafiltration rate (ex. 1.0Uhr) Green - Enter DIALYSATE flow rate (ex. 3.0 Llhr) (Will do this step later when Blood Flow achieved)

How Fast Screen Red -This is the starting Blood flow. Zoo Yellow-This is how fast Fluid is removed from you per hour.

,g

Training/reference

material. Not intended to replace User's Guide.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A
\

Prepare for Patient Connections


Close all 8 clamps. (2 red, 2 blue, 2 yellow, 1 green and white) -. Prime saline "T" (~9-~tfamp) and clamp.
Using pure flow, press GO and prime one port on the chicken foot. Clamp small green clamp on line.

Attach saline line (white) to saline "T" (.a:ea Whl~ clamp) DO NOT UNCLAMP Connect cartridge therapy fluid inlet (green) to warmer outlet or Pure Flow cabinet (green) and unclamp. Clamp and disconnect drain line (yellow) and connect to drain line extension or Pure Flow cabinet on front, then unclamp. Wash Hands Prepare the vascular access
Training/reference

~6D

vn~

If already done, skip this step.

material. Not intended to replace User's Guide.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A
(

w~ U&~6up
Launch Treatment
Connect to Patient Access:
Clamp and disconnect red and blue patient lines from the priming spike. Connect to patient access and unclamp

Verify:

Wh-,1-e...
white clamps)

1. Saline line is double clamped ~and

2. Dialysate fluid lines (green clamps) are unclarnped And if using bags: The unused MLA lines are clamped The warmer is turned to the 12 o'clock position The warmer air trap vent is clamped The warmer outlet and fluid inlet line are unclamped 3. Patient lines (red and blue) are unclarnped 4. The waste line and the drain line extension or to Pure Flow cabinet are unclarnped.

Start therapy
Press GO on pure flow control panel (If not done) Press TREATMENT (see 7, then 8 in yellow caution window). Increase to prescribed blood flow and then Dialysate.
Training/reference material. Not intended to replace User's Guide.

Increase dialysate (GREEN arrow) until #3 in yellow display


\.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A
(

Monitor Treatment
Document on flow sheet as directed Monitor:
Access pressure (i.e. 50 to 200) Venous pressure (i.e. <250-300) Effluent pressure (close to venous pressure) Ultrafiltration volume (actual fluid removed) Rates: therapy fluid, ultrafiltration, blood flow Ensure patient lines are visible Vital signs and response to therapy. DIALYSATE bags draining equally Saline line is primed and double clamped (red and white clamps) Warmer air trap full, vent if necessary Arterial pressure pod full - pressures within range Post-filter cap for air (if so, extract air with a syringe, hold the syringe upright and inject any blood back through the post filter cap port then clamp the post filter cap port securely). Promptly respond to all Alarms and Cautions

Access max: 260 Venous max: 300 Effluent: close to venous pressure

Training/reference

material. Not intended to replace User's Guide.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A
I

10

Treatment: Common Procedures


Saline Bolus:
Note volume of saline in bag Open saline line white clamps) and allow desired amount of saline to infuse, then reclamp Evaluate need to add saline bolus volume to fluid balance calculations

(~'rrfu

Bolus/Flush Filter to Check for Clotting:

h'I{-e...

Note volume of saline, open saline line (~ and white clamps) and occlude arterial patient line proximal to saline "T" . When complete, remove occlusion to arterial patient line and reclamp saline line (j:et1 and white clamp) vJh~e... Add saline bolus volume to fluid balance calculations if not previously added in to the total UF goal at the beginning of treatment.

Training/reference

material. Not intended to replace User's Guide.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A

11

Temporary Disconnection
Recirculation of the Blood Circuit Complete rinseback, ending with the arterial patient line (red clamp) connected to the priming spike (red port). Clamp and disconnect venous patient line (blue clamp) from the access, attach it to the priming spike (blue port), then unclamp. Press TREATMENT and set therapy fluid at 0.1 L/hr, ultrafiltration rate to zero and increase blood flow rate to 250-350 ml/min to create venous pressure of 40 or higher.
Low venous pressure alarms may occur. If so, reset alarm and increase blood flow rate to increase venous pressure.
Training/reference material. Not intended to replace User's Guide.

i.e. difficulty with access

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A

12

End of Treatment and Return Blood (Routine)


"000" will appear in yellow caution window Treatment targets have been met and blood pump continues to run Make sure enough saline is available to rinseback the blood. (300-500ml) Press STOP to stop blood pump and move the cycler into rinseback mode then press STOP on Pure Flow to pause batch. Clamp and disconnect arterial patient line (red clamp) from patient and reconnect to red port on the priming spike, and unclamp. Press ADD FLUID to rinseback blood (see countdown to zero and will stop automatically). Clamp and disconnect the venous patient line (blue clamp) from the patient and reconnect to the blue port on the priming spike. Close Green (non reopening) clamp on Pure Flow line and clamp small green clamp.
Training/reference material. Not intended to replace User's Guide.

Draw up flushes in the syringes that are hanging from the priming spike.

Attach syringe to patients arterial line and flush.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A

13

End of Treatment and Return the Blood (Operator End)


Press and hold STOP for 2 seconds to see "000" in yellow display (therapy fluid and UF rates go to zero, but blood pump stays on) Make sure enough saline is available to rinseback the blood. (300-500ml) Press STOP to stop blood pump. Press STOP on Pure Flow to pause batch. Clamp and disconnect arterial patient line (red clamp) from patient and reconnect to red port on the priming spike, and unclamp. Press ADD FLUID to rinseback blood (see countdown to zero and will stop automatically). Clamp and disconnect the venous patient line (blue clamp) from the patient and reconnect to the blue port on the priming spike. Close Green (non reopening) clamp on Pure Flow line and clamp small green clamp.
Training/reference material. Not intended to replace User's Guide.

Draw up flushes in the syringes that are hanging from the priming spike.

Attach syringe to patients arterial line and flush.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A

14

Return the Blood (Rinseback) - Alternate


To be used when the rinseback is unplanned Make sure enough saline is available to rinseback the blood. (300-500ml) Press STOP Clamp and disconnect arterial patient line (red clamp) and reconnect to priming spike (red port), and unclamp. Press TREATMENT You may decrease blood flow rate to 200ml/min
-You may need to decrease therapy fluid rate in order to decrease blood flow rate.

i.e. still in treatment mode and there is time to move the arterial patient line.

A low venous pressure #20, #21 may occur with the blood pump rate turned down).

When venous patient line (blue clamp) is clear, press STOP. Clamp and disconnect venous patient line (blue clamp) from patient and reconnect to the blue port on the priming spike.
Training/reference material. Not intended to replace User's Guide.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A

15

Return the Blood (Rinseback) - Alternate


To be used in an Emergency Make sure enough saline is available to rinseback the blood. (300-500ml) Open saline clamps on priming line (ensure flow), clamp the arterial patient line proximal to saline "T", and allow saline to infuse and return the patient's blood. You may decrease blood flow rate to 200ml/min
-You may need to decrease therapy fluid rate in order to decrease blood flow rate.

(i.e. prolonged troubleshooting or unable to move arterial patient line)

A low venous pressure #20, #21 may


occur with the blood pump rate turned down).

When venous patient line (blue clamp) is clear, press STOP. Clamp and disconnect venous patient line (blue clamp) from patient and reconnect to the blue port on the priming spike.
Training/reference material. Not intended to replace User's Guide.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A

16

Troubleshooting
Press MUTE Identify condition and follow instructions to correct the problem Press STOP Press TREATMENT to continue

Training/reference

material. Not intended to replace User's Guide.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A

17

Commonly Encountered Alarms


Alarm # 24 Check Arterial Access: Access Pressure at Low Limit

Cause
Arterial line kinked or clamped OR Access pressure pod error

How to Correct
Check arterial access or unkink or unclamp red line OR See Alarm Chart (C-6) Follow steps for resetting access pressure pod membrane. See Alarm Chart (C-6) Follow steps for resetting access pressure pod membrane. Check arterial needle, unkink or unclamp red line, check blue line, check for clotted filter with saline bolus.

25 20 21-

Access Pod Error:

Reset Access Pressure Pod

Access pressure pod connection kinked, OR clamped, leaking, or not connected OR Access pressure pod error Arterial line kinked or clamped OR venous line disconnected, OR clotted filter

Check Blood Circuit:

Venous Pressure Low Check Blood Circuit:

Venous Pressure Low Decreasing


Training/reference material. Not intended to replace User's Guide.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A

18

l.'

Commonly Encountered Alarms


Alarm # 11
- Check for Arterial air

Cause
Air entering blood circuit, OR poor flow through arterial access OR Loose connection at arterial access Air entering blood circuit, OR Arterial connection loose OR Arterial access dislodged or disconnected Drain line occluded, OR therapy line occluded, OR clotted filter

How to Correct
Follow steps for arterial air recovery on alarm chart (C-3)

10 -

Check for venous air

Follow steps for venous air removal on alarm chart (C-7)

37 ,38 35 Pressure High

High balance

chamber pressure Check Waste Line Empty Therapy Fluid Bags OR Loose Therapy Fluid connection OR Warmer disposable air trap full of air

Check for closed clamps or cap on drain line, check for closed clamps on therapy fluid line, check for kinked lines on dialyzer.

14 -

Check Fluid Line

Inlet: Air Detected in Fluid Line Inlet


Training/reference

Gently pull on the inlet and outlet lines of the Fluid warmer bag.

material. Not intended to replace User's Guide.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A

19

,
<l

NxStage Customer Service


1-866-NXSTAGE (1-866-697 -8243) 24/7 Technical/clinical support

Training/reference

material. Not intended to replace User's Guide.

2006 NxStage Medical, Inc. NxStage is a registered trademark of NxStage Medical, Inc. Patents and patents pending. Detailed reference list provided upon request. FOR PRESCRIPTION USE ONLY. TM0091 Rev A

20

NxStage Yellow Caution Alarm Codes


Display
000
1 2 3 4
5

Cause
End of Treatment / Rinseback Infusing Fluid Bolus Fluid Balance System Check Parameter Limit Exceeded Blood Pump Off Target Volume Reached Blood Circulation Only Alarms Overridden Pressure Limits Not Locked Auto High Pressure Recovery Air Recovery Underway Air Detected in Fluid Line Inlel Venous Pressure Low Venous Pressure Decreasing Effluent Pressure Decreasing Access Pressure Decreasing to Low Limit Access Pod Error/Rest Access Pressure Pod Filter Pressure Error/Reset Filter Pressure Pod Venous Pressure Approaching High Alarm Limit Check Filter for Clotting Venous Pressure Increasing Power Failure Fluid Cooldown Underway Continue Treatment/Fluid Cooldown Complete Cartridge Life Exceeded Preventive Maintenance Due Treatment Complete Reconfigure Cartridge Line Tap Filter to Remove Air (Optional) Pressure Offset Rezeroing Needed Correct Settings Conflict Service Mode Activated

Action
None None None Set a Value Too Low or Too High Press Treatment/Add Fluid to Continue UF Volume Target Reached Fluid Removal Rates Set to Zero Temporary Override of Alarms (Monitor until Green) Pump Rate Change (Monitor until Green) Alarm Reset After Red Alarm (None) If No Air Noted Press Treatment to Continue/If Air Remove
Empty Therapy Fluid Bags/Loose ConnectionslWarmer Full of Air/Air in Tubing Arterial Flow Problem KCONenous Line Leak or Disconnection/Clotted Filter Arterial Flow Problem KCONenous Line Leak or Disconnection/Clotted Filter Arterial Flow Problem KCO/Clotted Filter/Filtration Fraction Too High Arterial KCO/Clotted Filter/Filtration Fraction Too High/Effluent Line KCO

6 7 8
9

12 14 20 21 23 24 25 27 30 31 32 40 51 52 70 71 72 80 81 88 93 999

Access Pressure Connection KCO, Leaking or Not Connected Filter Pressure Connection KCO, Leaking or Not Connected Venous Flow Problem KCONenous Needle Infiltration Clotted Filter Venous Flow Problem KCONenous Need Infiltration or Clotted If Power Restored/Press Treatment/Add Fluid to Continue Red Alarm-50 Cleared Fluid <38.5 C after Red Alarm-50 Press Treatment to Resume Cartridge TimeNolume Limit Exceeded/End Tx Replace Cartridge Complete Treatment and Schedule Maintenance User Opened Door at End of Treatment Operator Parameter #25 set to 1/Press Add Fluid to Continue Filter May Be Checked For Air/Priming Procedure Underway
Cycler was Powered Up with Door Closed and/or a Cartridge Installed Parameter Set to a Value Which Conflicts with Previous Value/Re-Enter Values

DO NOT INITIATE TREATMENT/CALL NxSTAGE


Handbook TabS Alarm Codes Page 2 of 2

2009 DaVita Inc. All rights reserved.

Proprietary and Confidential - For internal use only. May not be copied or distributed without written permission from DaVita Inc.

Description
Alarm Test Passed Venous Air Arterial Air Check Fluid Line Inlet (Air Detected) Venous Pressure Low (Blood Circuit) Venous Pressure Decreasing (Blood Circuit) Effluent Pressure Low (Blood Circuit) Effluent Pressure Decreasing (Blood Circuit) Access Pressure at Low Limit Venous Pressure High Clotting Detected High TMP: TMP >500mmHg Waste Line Pressure High Fluid Balance System Failure High Balance Chamber Pressure Therapy Inlet Occlusion Failed Power Recovery Fluid Temperature High Blood Detected in Effluent Line Failed Blood Leak Detector Waste Line Check Failure Failed Alarm Test UF Occlusion Test Failure Pressure Offset Rezeroing Needed Pressure Offset Rezeroing Failed Fluid Circuit Test Failure Cartridge Leak Probable System Alarms Blood Leak High
2009 DaVita Inc. All rights reserved.

Action
None Required Assess For Air (Pt to blood pump) Check Connections/Poor Flow Check Priming Fluid/Kinked Tubing KCO in Pt Arterial Line/Poor Arterial Flow/Clotted Filter KCO in Pt Arterial Line/Poor Arterial Flow/Clotted Filter
Arterial Flow Low/KCO Effluent Line/Filtration Fraction Too High/Clotted Filter Arterial Flow Low/KCO Effluent Line/Filtration Fraction Too High/Clotted Filter Assess KCO in Pt line/Poor Arterial Flow/Arterial Pressure Pod error

Assess KCO in Venous LineNenous Line Clotted Check Filter for Clotting/Clotted Filter
Check Filter/KCO Venous Filter Line/Clotting Venous Header Waste Line occluded/Waste Bag Full/Low effluent pressure-Low Arterial Flow

TERMINATE TREATMENT
KCO in Circuit line/Clotted Filter/Air or Fluid in Balancing System Check Fluid Inlet/Air or Fluid in Balancing System

Perform Manual Rinseback If System Not Clotted Warmer Set Too High/Therapy Fluid Bags too Warm Filter Membrane Leak/Air in Effluent/Filtration Fraction Too High Blood Leak Detector Lens and/or Mirror Not Clean Cartridge Not Properly Loaded Improper Priming/Faulty Cartridge/Cycler Malfunction Cartridge Not Properly Loaded Blocked/Kinked Fluid Lines/Pressure Offset Error Cycler Unable to Adjust Variable Pressure Offset on Start up Check Cartridge for Leaks/Malfunction of Fluid Balancing System Cartridge Integrity Compromised System Error/lnternal Communication Error
Indicates Blood Leak Detector Malfunction/Fluid Has Interfered with Blood Leak

Handbook TabS Alarm Codes Page 1 of 2

Proprietary and Confidential - For internal use only. May not be copied or distributed without written permission from DaVita Inc.

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