5008 CorDiax and 5008S CorDiax Therapy System Basic Training Record Nov 2015

Preparation for Training and Practice

The operating instructions must be studied before attempting to operate the device Before the responsible organisation can begin to operate the device, the individuals responsible for the operation must have been instructed by the manufacturer on how to use the device and must be thoroughly familiar with the operating instructions The device may only be operated by individuals who have been trained and certified in the proper operation and handling of the device. The training must be documented in the enclosed training record 5008 Haemodialysis System Operating Instructions Software Version: _________

Preparation for Training Literature and Resources Please indicate that you have available and have familiarised yourself with the following before commencing the practical training section of this document;-

Please Sign

Indicate if Not Applicable

Date

5008 Cordiax Online Learning Course 5008S Cordiax Online Learning Course 5008 Haemodialysis System Operating Instructions Software Version:___________

System Brief Guide Problem Solving Guide

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Record of Practical Training

Date Standard Machine Operation

Section Completed 1

Trainee Signature

Trainer Signature

Preparation of System for Treatment

2 Priming of Extracorporeal

Blood Module (EBM) 3 Programming and using

the Patient Card 4 Data Entry 5 Connecting a Patient

and Starting Treatment 6 Recording and Monitoring

Blood Pressure 7 Monitoring Treatment

and Alarm Handling and Emergencies 8 Problem Solving 9 Click-Clack - Single-

Needle/Single-Pump Dialysis 10 Mains and System

Failure Handling 11 Reinfusion and Saving

Treatment Data to Patient Card 12 Removing Lines, Surface

and System Disinfection and Switch-off 13 Changing the Diasafe

Online Plus Filters All warnings of the IFU have been discussed Software Upgrade Training

Software Upgrade Training V______ Software Upgrade Training V______ Software Upgrade Training V______ Software Upgrade Training V______

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Section 1 Preparation of System for Treatment Demonstrated (D ) Practised (P)

Prepare System

D

P

Notes/Tips

Connect to RO water and drain

Connect to power and switch-on system

Check for last disinfection and choose if required or select treatment

Check for residual disinfectant if required

Connect acid concentrate and bibag

Note T1 test has started

Insert dialyser into holder

If arterial pressure measurement unit fails to open on insertion of line guide with audible signal - remove line guide, close the doors and wait for pump rotors to move to correct position. Reinsert line guide and continue

Insert and connect A line to dialyser Check heparin syringe size Recommended to connect heparin syringe before priming commenced

If required, connect and insert heparin syringe

If no heparin syringe in use – check cap on line and close line clamp

Insert and connect V line to dialyser

Using ‘locator’ ensure that bubble catcher is in the correct position Ensure that transducer connector is correctly and firmly attached

Connect rinse connector to V line Ensure closure of all small white clamps and check protective caps

Insert and connect SafeLine to A line Check all lines are free of kinks, tension and twists

Connect SafeLine to substituate port

At successful completion of T1 test

Connect patient V line to rinse port

Close doors

Connect dialysate couplings to dialyser Note onscreen information re: priming of dialyser

Trainee confirms that he/she is satisfied with their knowledge and practice for Section 1 – Preparation of System for Treatment

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Signature

Date

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Section 2 Priming of Extracorporeal Blood Module (EBM) Demonstrated (D ) Practised (P)

Online Priming of EBM

D

P

Notes/Tips

Start prime/rinse

Demonstrated (D ) Practised (P)

Priming with Saline

D

P

Connect A line to saline

Notes/Tips Before starting prime Ensure closure of all small white clamps and check protective caps Check all lines are free of kinks, tension and twists Check all lines are secured in holders

Connect V line to waste bag

Start prime/rinse

Identify completion of prime/rinse

Connect lines for pre-circulation and commence Demonstrated (D ) Practised (P)

Separately Prime SafeLine

D

Identify prime/rinse is complete

P

Notes/Tips Before starting prime Ensure closure of all small white clamps and check protective caps Check all lines are free of kinks, tension and twists Check all lines are secured in holders

Stop blood pump and insert SafeLine

Prime SafeLine

Press exit

Connect SafeLine to pre- or post-dilution port as required

Trainee confirms that he/she is satisfied with their knowledge and practice for Section 2 – Priming of Extracorporeal Blood Module (EBM)

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Signature

Date

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Section 3 Programming and using the Patient Card Demonstrated (D) Practised (P)

Programme Patient Card

D

P

Notes/Tips Choose ‘System Menu’- Applications - Patient Card Note: This is only possible when there isn’t a patient connected

Insert card and programme patient details

Enter first name, surname, date of birth ID only required for network

Follow onscreen instructions to create card

Using a Programmed Patient Card

Demonstrated (D ) Practised (P)

D

Insert card, confirm patient name and D.O.B

P

Notes/Tips Check for data plausibility and compliance with medical prescription and confirm

Change treatment parameters if required

At end of treatment follow onscreen messages to save prescription and treatment data

Accept any changes in prescription if appropriate

Remove card

Trainee confirms that he/she is satisfied with their knowledge and practice for Section 3 – Programming and using the Patient Card

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Signature

Date

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Section 4 Data Entry Demonstrated (D ) Practised (P)

Dialysate Menu

D

P

Notes/Tips

Check for correct acid concentrate

Enter data for Na+ and bicarbonate

Demonstrate understanding of autoflow factors

Enter dialysate flow or use autoflow factor

Check/enter temperature

If required Choose Na profile and set start value

Demonstrated (D ) Practised (P)

UF Menu

D

P

Notes/Tips

Enter UF goal

Enter UF time

Check UF rate

If required Choose UF profile and select start rate

The UF goal can be changed without interrupting the running profile (automatically adjusts) Profile 1 & 2 min. goal 200mls / min. UF time 2hrs /UF rate 50mls Profile 3 min. goal 200mls / min. UF time 3½ hrs /UF rate 50mls

If required Set isolated UF goal and time

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If a UF profile is programmed in combination with an ISO UF, the ISO UF will start first If there is no UF profile programmed, the ISO UF can be started at any time during the treatment

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Section 4 Data Entry continued

Demonstrated (D) Practised (P)

Heparin Menu

D

P

Set /check heparin infusion rate

Notes/Tips Heparin connection test performed during preparation - 1.1ml is discharged during the connection test, fill volume of heparin line is 0.6ml, 0.5ml is administered into the ECB Test can be repeated if does not pass (check total volume delivered and take account in calculation of the total heparin volume)

If required, set heparin stop time

Manual or automatic bolus available

If required, set heparin bolus

Demonstrated (D) Practised (P)

Online Menu

D

P

Notes/Tips

Check for correct dialyser choice

Check treatment mode

Demonstrated (D ) Practised (P)

System Menu

D

P

Notes/Tips

Entry of reminder message

Entry of reminder time or remaining time

Auto-fill of blank value

Starting timer

Confirm timer message

Trainee confirms that he/she is satisfied with their knowledge and practice for Section 4 – Data Entry

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Signature

Date

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Section 5 Connecting a Patient and Starting Treatment Demonstrated (D ) Practised (P)

Online Pre/Post-Connection

D

P

Notes/Tips

Identify that rinse volume has been reached and status line is grey

Check that blood line is air-free

Stop the blood pump

Follow on-screen instructions to connect bloodlines to patient’s access and SafeLine to pre/post-dilution port

For online HD – connect SafeLine to post-dilution port

Start the blood pump

Respond to message ‘blood detected – treatment start’

Adjust blood flow

Observe A & V pressure display

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Section 5 Connecting a Patient and Starting Treatment continued

Demonstrated (D ) Practised (P)

NaCl Prime Connection

D

P

Notes/Tips

Identify that rinse volume has been reached and status line is grey Check that blood line is air-free

Stop the blood pump

Follow on-screen instructions to connect bloodlines to patient’s access Start the blood pump

Respond to ‘blood detected – treatment start’ Adjust blood flow

Observe A & V pressure display

Demonstrated (D ) Practised (P)

Heparin

D

P

Notes/Tips

If manual start – commence heparin infusion Administer heparin bolus if required

Demonstrated (D ) Record Patient and System Observations

Practised (P)

D

P

Notes/Tips

Record observations as per unit protocol

Trainee confirms that he/she is satisfied with their knowledge and practice for Section 5 – Connecting a Patient and Starting Treatment

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Signature

Date

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Section 6 Recording and Monitoring Blood Pressure Demonstrated (D ) Practised (P)

Using BPM Module

D

P

Notes/Tips

Choose appropriate cuff and size

Correctly apply cuff

Manual BPM

Time interval – BPM

‘Quick’ BPM

Set alarm guards

BPM graphic displays

Last recorded BPM will be visible on screen saver if requested in set-up

Demonstrated (D ) Practised (P)

Using External BPM Device

D

Enter data directly in BPM menu

P

Notes/Tips Only available where BPM module is not installed

Or select ‘not measured’

Trainee confirms that he/she is satisfied with their knowledge and practice for Section 6 – Recording and Monitoring Blood Pressure

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Signature

Date

02/09/2016 11:23

Section 7 – Monitoring Treatment – Alarm Handling and Emergencies Demonstrated (D ) Practised (P)

Changing Treatment Mode

D

P

Notes/Tips

Using online menu change HD-HDF- pre/post-dilution Demonstrated (D ) Practised (P)

Pressure Alarms

D

P

Notes/Tips

Arterial and venous pressure alarms Low arterial pressure (using ‘reduce’ button) Changing pressure alarm guards if required Demonstrated (D ) Symptomatic Hypotension in Online Treatment

Practised (P)

D

P

Stop UF

Notes/Tips Note delivery rate of online bolus and change to manual if appropriate

Check blood pressure If required – administer online bolus Symptomatic Hypotension Emergency in Online Treatment Press emergency RED CROSS button

Check the default emergency settings to know what is included Possible default settings include – UF stopped Reduced blood flow Online bolus BP measurement

On recovery, exit emergency mode by pressing RED CROSS button again – reset blood flow

Note delivery rate of online bolus and change to manual if appropriate

Demonstrated (D ) Practised (P)

Conductivity Alarm

D

P

Notes/Tips

Check concentrates Correct problem causing the alarm

Trainee confirms that he/she is satisfied with their knowledge and practice for Section 7 – Monitoring Treatment and Alarm Handling and Emergencies

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Signature

Date

02/09/2016 11:23

Section 8 Problem Solving Demonstrated (D ) Practised (P)

Circulation of the Blood

D

P

Press circulation button

Notes/Tips Maximum recirculation time – 30 mins. Machine alarms at 10 min intervals

Follow on-screen instructions for circulation

Reconnect blood lines to patient access

Demonstrated (D ) Circulation after Returning Blood to Patient

Practised (P)

D

P

Notes/Tips

Choose online reinfusion

Re-infuse blood until OD detects light then give an additional 30ml by selecting ‘Continue’ Stop reinfusion and choose ‘Treatment’

Warning ‘No blood detected’ – move all messages to status line using X button

Connect A & V line

‘Stop circulation’ will remain on screen – confirm when ready to reconnect Programme active for 10 mins and can be repeated

Select ‘Circulation’ Press ‘Start’ Move messages back to screen Confirm ‘Start’

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Section 8 Problem Solving continued

Demonstrated (D ) Practised (P)

Air Handling

D

P

Microbubbles

Notes/Tips A microbubble alarm may be repeated x 3 before full air handling procedure is required

Respond to machine alarm

Visual check for microbubbles

Column of air Respond to machine alarm

Use a Y-connector and spike to connect both bloodlines to a bag of saline

Follow onscreen instructions

Reconnect patient

Demonstrated (D ) Practised (P)

Level in Bubble Catcher

D

P

Notes/Tips

Changing the level in bubble catcher

Reducing high pressure in bubble catcher

Handling low level alarms

Remember to make a visual check before raising level If level is correct – ensure that level detector and bubble catcher is clean and dry

Demonstrated (D ) Changing Wet Transducer Protector

Practised (P)

D

P

Replace wet transducer protector

Notes/Tips If blood has made contact with the transducer protector - check for breach and remove machine for decontamination if required

Demonstrated (D ) Practised (P)

Kinking/Clotting Warning

D

P

Notes/Tips

Check circuit for kinks or signs of clotting

Choose from ‘problem solved’ or ‘adapt treatment’

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Section 8 Problem Solving continued

Demonstrated (D) Haemoconcentration Warning

Practised (P)

D

P

Notes/Tips

Handling of warning messages

Opening the Arterial Pressure Measurement Unit with Blood in the System

Demonstrated (D ) Practised (P)

D

P

Move the check valve to deaeration luer lock

Notes/Tips 5008 – in Diasafe plus cupboard 5008S – at rear of machine

Use syringe to introduce air to open arterial pressure measurement unit

Return check valve to parking position

Demonstrated (D ) Practised (P)

Arterial Pressure Reduction

Select ‘Reduce’ on lower arterial pressure alarm

D

P

Notes/Tips Aspiration of a double-lumen catheter or of a sucked needle can cause a lower arterial pressure alarm Ensure you check the arterial line is air-free and correctly connected to the access

Message: arterial pressure reduction – arterial blood line completely air-free? – arterial patient access correctly connected to the arterial blood line? – Check the blood line and access and press confirm when appropriate Machine will close arterial clamp and reverse the blood pump at a speed of 30ml/min to reduce arterial pressure Once the current pressure value has returned to within the alarm window, the following message appears: blood flow reduced – increase blood flow rate Confirm and raise blood flow rate if necessary

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Section 8 Problem Solving continued

Demonstrated (D) Practised (P)

Venous Access Monitoring

D

P

Respond to machine alarm

Notes/Tips The VAM detects a pressure loss at the venous vascular access, which might be a result of a dislocation of the venous needle. However, please ALWAYS observe the patient’s condition, the security of the needles and the condition of the bloodlines The VAM is active in HD, HDF and HF but is disabled in single-needle modes The VAM detects the pressure drop in the venous vascular access and emits an alarm. The blood pump stops running and the venous clamp is closed

Check venous access

Discuss instances when ‘Deactivate’ option would be appropriate

Demonstrated (D) Practised ( P) Blood Leak

D

P

Notes/Tips

Dimness Warning Respond to alarm; use ‘?’ to detect cause and press confirm

If the dimness warning was caused by calcium/grease deposits, perform a cleaning/disinfection program after the treatment

Blood Leak Follow local procedure to confirm authenticity where appropriate

Blood leak override will be displayed in the ‘Current Messages’ field Override time: 2 minutes each time the key is pressed The alarm indicator with go out if the leak is closed If not, follow unit/trust protocol

Select ‘Override’

Severe Blood Leak Follow local procedure to confirm authenticity where appropriate

Blood leak override will be displayed in the ‘Current Messages’ field Override time: 1.5 minutes each time the key is pressed The alarm indicator will go out if the leak is closed If not, follow unit/trust protocol

Select ‘Override’

Trainee confirms that he/she is satisfied with their knowledge and practice for Section 8 – Problem Solving

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Signature

Date

02/09/2016 11:23

Section 9 Click-Clack – Single-Needle/Single-Pump Dialysis Demonstrated (D) Single-Needle/Single-Pump Click-Clack

Practised (P)

D

When to use click-clack

P

Notes/Tips Use in exceptional cases only due to high recirculation Can be started at any time after rinse volume reached or during treatment

Connect A & V bloodlines to vascular access using Y-connector

Check and confirm parameters

Lower SN pressure must be higher than the venous pressure

Press and confirm SN start key

Online treatments will not be available Online bolus is available OCM BTM BVM UF/NA profiles are deactivated

Handle cycle alarm

Reinfusion following SN click-clack

Trainee confirms that he/she is satisfied with their knowledge and practice for Section 9 – Click-Clack – Single-Needle/Single-Pump Dialysis

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Online reinfusion is available. SN click-clack will deactivate at start of reinfusion

Signature

Date

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Section 10 Mains and System Failure Handling Demonstrated (D) Practised (P)

Mains Failure

D

P

Describe machine operation during ‘Battery Operation’

Notes/Tips If the message ‘Defective Battery – Skip’ is acknowledged by pressing the ‘Skip’ Key, it is possible that the audible alarm will not be generated when a power failure occurs

Restore treatment when mains power is restored

Manual reinfusion if power is not restored and battery power unavailable

Demonstrated (D) Practised (P)

Screen Failure

D

P

Notes/Tips

Demonstrated (D) Practised (P)

System Failure

Trainee confirms that he/she is satisfied with their knowledge and practice for Section 10 – Mains and System Failure Handling

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D

Signature

P

Notes/Tips

Date

02/09/2016 11:23

Section 11 Reinfusion and Saving Treatment Data to Patient Card Demonstrated (D) Practised (P)

Reinfusion at Planned End

D

P

Notes/Tips

Online reinfusion

Reinfusion with NaCl (saline)

Switching from online to NaCl (saline) reinfusion

Demonstrated (D) Reinfusion before Planned End of Treatment

Practised (P)

D

P

Notes/Tips

Online reinfusion

Reinfusion with NaCl (saline)

Switching from online to NaCl (saline) reinfusion

Demonstrated (D) Practised (P)

Save Data to Patient Card

D

P

Notes/Tips

Leave card inserted and follow onscreen instructions

Remove card

Trainee confirms that he/she is satisfied with their knowledge and practice for Section 11 - Reinfusion and Saving Treatment Data to Patient Card

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Signature

Date

02/09/2016 11:23

Section 12 Removing Lines, Surface and System Disinfection, Switch-off Demonstrated (D) Practised (P)

Remove Lines

D

P

Notes/Tips

Follow onscreen instructions to drain dialyser and remove lines

Auto or manual draining of bibag

Demonstrated (D) Practised (P)

Surface Cleaning

D

P

Dialyser couplings

Notes/Tips Clean before starting system disinfect Do not open sub and rinse port If required – clean sensor heads with damp cloth only

Shunt interlock

Sealing area bibag

Concentrate gaskets

‘Freeze’ and ‘Unfreeze’ screen in treatment or cleaning mode

Demonstrated (D) Practised (P)

System Disinfection

D

P

Notes/Tips

Citrosteril and heat disinfection

It is imperative to disinfect the device after 72hrs of downtime

Sporotal disinfection

Weekly clean as per unit protocol Auto or manual check for residual disinfectant

Auto shut-off or press and hold On/Off for 3 seconds

Trainee confirms that he/she is satisfied with their knowledge and practice for Section 12 – Removing Lines, Surface and System Disinfection, Switch-off

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Signature

Date

02/09/2016 11:23