SW 8.09.13

Training Module 3 – Hygienic ChainRef: Operator ’s Manual SW 8.09.13

-­ Chapter 13 – Disinfection/Rinse-­ Chapter 8 – Special Procedures

Dialysis System

2

Hygienic Chain preserved

Important Notice:This presentation does not relieve any user of the Artis Dialysis System from his or her duty to carefully read the full text of the Operator ’s Manual before using the system.

incoming water

pretreatment

reverse osmosis

distribution system

no man’s line

Artis Dialysis System

concentrates

drain

3

Dialysis – a two way process

Back transport of solutes in the dialyzer is not only pressure dependent

Solutes follow the concentration gradient in any direction …

… also the non-­desired …

Impure1 dialysis fluid is contributing to inflammation in HD patients1: Ward and Ing. Product Water and Hemodialysis Solution Preparation;; Handbook of Dialysis

2007;; 4th edition: 79-­86

4

Microbiological ContaminationA common scenario2

reverse osmosis

distribution system

dialysis machine dialyzer

concen-­trates

log CFU/ml

2: Ward and Ing. Product Water and Hemodialysis Solution Production, Handbook of Dialysis 2007;; 4th edition: 79-­86

(hours)0 2 4

5

Dialysis Fluid Quality Considerations

• High microbiological quality of dialysis water and concentrates is important for all types of hemodialysis– “The use of ultrapure water is strongly recommended for conventional and high-­flux dialysis modalities”

[EBPG 2002 on Dialysis Fluid Purity]

• Microbiological organisms are small enough to pass across membranes3

• Some synthetic membrane material effectively adsorbs cytokine-­inducing contaminants of bacterial origin

3: Ward and Ing. Product Water and Hemodialysis Solution Preparation Handbook of Dialysis2007;;4th edition: 79-­86

6

Ultrafilters -­ Principles of Operation

Microorganisms are removed by size exclusion 4

Retention of microorganisms Retention of endotoxins

Endotoxins are removed by adsorption

4: Ward and Ing. Product Water and Hemodialysis Solution Preparation Handbook of Dialysis2007;;4th edition: 79-­86

7

The U900 filters:• Are disinfected at each disinfection program • Life expectancy depends on whichever comes first of:

-­ the number of days in the circuit -­ max 90-­ the number of heat disinfections -­ max 150-­ the number of hypochlorite disinfections -­ max 12

• Are easily replaced • Reminder countdown starts 3 days / disinfections before usage limit is reached -­ alarm #402

• When reached, Ultrafilter change is a prerequisite to get access to the next treatment -­ alarm #571

Ultrafilters on Artis

Ultrafilter

Ultrafilter

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Ultrafilter change

After the Ultrafilters are changed, turn the Artis OFF – a heat disinfectionis automatically started when the Artis is turned ON again

5: Ward and Ing. Product Water and Hemodialysis Solution Preparation Handbook of Dialysis 2007;;4th edition: 79-­86

• Ultrafilters change procedure is available in the standard environment• Ultrafilters history table is always available• Default values for Ultrafilters history counters correspond to the maximum authorized duration

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Three Maintenance Routines related to the dialysis fluid pathDisinfection Decalcification Cleaning

• Water born bacteria and fungi• Blood born microorganisms

• Organic deposits• Fats• Proteins

• The disinfection method used• Concentration of disinfection agent• Exposure time (dwell time)• Temperature

• Decalcification agents have a low pH

• Citric acid is commonly used for decalcification

• Water temperature is the most important factor in the decalcification process

• A 10ºC temperature increase doubles the effect 6 A

• Usually cleaning agents have a high pH

• Water temperature is the most important factor in the cleaning process

• A 10º C temperature increase doubles the effect 6 B

Ca2+ HCO3-­

CaCO3

6, A-­B: Dr. Rolf Nystrand, Heat disinfection in Dialysis, Specktrumder Dialyse und Apharese;; Vol 05, No1, 2015

10

CleanCart-­C CleanCart-­A• Contains 32 g pure water free citric acid • pH = 2 (diluted solution)• Is intended for decalcification and disinfection of the fluid path 7

• Contains 13 g pure water free sodium carbonate

• pH = 11 (diluted solution)• Is intended for cleaning and disinfection of the fluid path 8

! Should always be used in combination with heat > 85oC, an environment sufficient to reduce log CFU with more than 5 units

! At 85oC hot water and pH 2 or pH 11 the disinfecting effect may be further increased 9

No residual test needed: Citric acid is metabolized in the body in the Krebs's cycle (citric acid cycle)10

No residual test needed: Sodium carbonate converts to sodium bicarbonate when the acid concentrate is added

7,8,9: Efficiency of disinfection ARTIS;; Dr. Rolf Nystrand, Enrico Marchetti, Jan 10, 2011,Gambro10: Data on file

11

Available disinfection programs

Disinfection Program Frequency Cycle Time (min) Chemical Solution

Heat Daily – between treatments 34 -­-­-­

Integrated Heat Automatically early in the morning 34 -­-­-­

Heat CleanCart-­C Daily – after the last treatment 44 Citric acid

Heat CleanCart-­A At least once a week* 44 Sodium carbonate

Chemical Daily – between treatments 16 Dis. + 27 Rinse Low per-­acetic

Chemical Daily – between treatments 16 Dis. + 38 Rinse Per-­acetic

Chemical At least once a week* 16 Dis + 96 Rinse Hypochlorite

Bacteriostatic week-­end storage with per-­acetic is also available*= in place of each other

Refer to Operator ’s Manual Disinfection/Rinse chapter 13.

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pH Sensor Option

The pH sensor usage is highly recommended when hypochlorite is included in the clinic’s policies and procedures for e.g.:

• Disinfection of machines

• Maintenance of the water plant

• Maintenance of the central concentrate delivery system

13

Disinfection – Heat / Chemical

Intake of citric and sodium carbonatepowder • CleanCart-­C• CleanCart-­A

Intake of liquid disinfectants • Per-­acetic• Hypochlorite

14

Disinfection / Rinse Settings

• Program selection(Process Type button)

• History table

• Auto Start table(Service Mode, level 1 & 2)

The manual Rinse program may be interrupted if needed

Treatment Overview screen

This screen is not available during treatments

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Post Treatment Cleaning

• Machine surfaces and components– See table in Operator’s Manual (Ethanol 70%, Isopropanol 60%, hypochlorite 1.5%, liquid soap)

– Touch screen: Only Isopropanol 60%

• EvaClean ports*– Using a priming connector (and luer-­lock syringe) -­ insert 15cc undiluted bleach (5.25 – 6 % sodium hypochlorite) into each EvaClean port when Artis is ON

– Followed by a heat disinfection w/wo CleanCart

• = Always clean the EvaClean ports each time the Patient Connection procedure is performed keeping the venous patient line into the EvaClean port until the machine detects blood, or if blood has accidentally entered any of the ports (as per Operator’s Manual )

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Display Off Mode

• After a rinse or disinfection program, the Touch Screen immediately switches off:

-­ The On/Off indicator is green lit

-­ The machine is still powered (i.e. automatic clamps are still open)

• Press the On/Off key on the hard key panel to start Artis

-­ Artis starts the self test procedures

Display Off Low PowerDisinfection Program End

Immediately Pre settable time10 min – 24 h

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Low Power Mode

-­ The Hard Key panel On/Off key is green lit

-­ The Main Switch On indicator is not lit

• Press the On/Off key on the hard key panel to “wake up” Artis

-­ Artis boots and loads the sw before it enables to start preparation

To wake Artis up from the low power mode after a scheduled program, it may be necessary to press the On/Off key twice

Display Off Low PowerDisinfection Program End

Immediately Pre settable time10 min – 24 h

Temperature self tests is skipped Conductivity self tests is skipped when same concentrate combination is used

Disinf.All Self-­Tests Treat. Disinf.

SkipTemp &Cond

Treat. Disinf.SkipTemp Treat. Disinf.All

Self-­Tests Treat.

Day 1 Day 2

BiCart or SelectPreparation

BiCart or SelectPreparation

AFBPreparation

AFBPreparation

Concentrate Type Change

Day Change

…

Diascan auto-­calibration

3-­5 minutes time reduction between treatments

Mean Time Between Treatments (MTBT)

18

19

The Auto Start Option

Automatic start scheduling of:Disinfection RinsePreparation

Maximum 3 programs per day

Conditions for Auto Start:• Artis is either in display off or in low power (main switch ON)

• Within 48 hours after Artis has entered the low power mode

• Water supply must be connected• Appropriate disinfectant connected

The Auto Start programs scheduled are displayed in the Disinfection/Rinse Settings screen

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Rinse

Auto Start Settings Screen

• Enter Service Level 1, code: 169000, to access the Auto Start Settings screen via the Default Settings list

• The Select pad offers 6 programs

• When the program is confirmed, its Start Time button becomes available

• Set the Start Time and Confirm, the End Time is automatically calculated.

• Start and End time is displayed on the button

Auto Start can be preset before Auto-­Prime start and after disinfection/rinse

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Nice to know – Auto Start

• Verify set date and time on Artis before Auto Start is scheduled

• If the On/Off key is pressed when Artis is in display off or low power mode, preparation starts and the scheduled program is aborted

• If Artis Main Switch is turned OFF the scheduled program is aborted. The alarm 562 will then appear when the Main Switch is turned ON again

• In case of short power failure (less than 5 minutes), the scheduled program is anyway completed

• In case the alarm “No power “Using Battery Backup “ is displayed for more than 5 minutes, the scheduled program does not start / is stopped and Artis automatically switches off

22

Integrated Heat Disinfection

23

Chemical Disinfection –Residual Test

• Collect test sample for disinfection residual from the dialysis fluid tube port before attaching concentrates when the ADS is disinfected with hypochlorite

• Collect test sample for disinfection residual from the dialysis fluid tube port before connecting the patient when the ArtisDialysis System is disinfected with per-­acetic

• When using CleanCart-­C / -­A, no residual test needs to be performed

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Greasing of the pressure pod O-­ringsTo maintain the O-­ring sealing capacity:• Inspect the O-­ring’s surface and metal stem

– Check for nicks, damage, wear, etc.– Replace if necessary

• Grease the O-­ring’s surface by applying a very thin layer of silicon grease, avoiding any grease entering the metal stem inside

– Silicon grease spare part code 6975395– Grease dispenser spare part code 6977854

– It is also possible to apply the grease by the use of a finger

This procedure should be performed on a weekly basis

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Hands on Module 4-­ Chemical residual test

-­ Disinfection programs

-­ Disinfection history list

-­ Pressure Pod greasing

-­ Auto Start Settings

-­ Ultrafilter change

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Recap of the learning so far

?

References

27

1,2,3,4,5: Ward and Ing. Product Water and Hemodialysis Solution Preparation;; Handbookof Dialysis 2007;; 4th edition: 79-­86

6, A-­B: Dr. Rolf Nystrand, Heat disinfection in Dialysis, Specktrum der Dialyse undApharese;; Vol 05, No1, 2015

7,8,9: Efficiency of disinfection ARTIS;; Dr. Rolf Nystrand, Enrico Marchetti, Jan 10, 2011, Gambro

10: Data on File

28

For safe and proper use of the device referenced within, refer to the Warnings, Precautions and the complete Instructions for Use or the appropriate manual available by contacting customer support.

CleanCart A and CleanCart C are Trademarks of Gambro AB. Gambro is an indirect subsidiary of Baxter International Inc.

Important:Please note that the SW change to 8.09.13 of this presentation does not change the content of the training of the Artis Dialysis System for users.