Dialog Dialysis Machine - bbraun.ee

1 Dialog + Dialysis Machine Instructions for Use SW CE marking according to directive 93/42/EEC Technical alterations reserved IFU 38910173 / Rev. / May 2010 B. Braun Avitum AG 34209 Melsungen, Germany Tel +49 (56 61) 71-3716 Fax +49 (56 61) 75-3716 Dialog + Overview 1 Safe handling 2 Product description 3 Installation and commissioning 4 Preparing for haemodialysis 5 Initiating haemodialysis 6 End of haemodialysis therapy 7 Disinfection 8 HDF-online/HF-online 9 Single-needle procedure 10 Use of options 11 Configuration 12 Maintenance and cleaning 13 Alarms and remedial action 14 Accessories 15 Technical data 16 Appendix 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 Table of contents Dialog + II IFU 38910173 / Rev. / May 2010 Dialog + Table of contents IFU 38910173 / Rev.

2 / May 2010 III Table of contents 1 Safe handling .. 1-3 About these instructions for use .. 1-3 Validity ..1-3 Target group ..1-3 Warnings, notices and symbols in these instructions for Abbreviations ..1-5 Intended use and 1-5 1-6 Side effects .. 1-6 Special hazards and 1-6 Special patient Electrical hazards ..1-7 Electromagnetic interactions ..1-7 Maintenance and filter Information for the operator .. 1-8 Training by manufacturer prior to Requirements on the user ..1-8 Conformity ..1-9 Manufacturer s Technical 1-10 Disposal and taking back of old Dialysis 1-10 2 Product description .. 2-3 Basic 2-3 Dialog + single-pump Machine ..2-6 Dialog + double-pump Machine ..2-7 Dialog + Symbols on the Dialysis Machine .. 2-9 Control elements and information on the monitor .. 2-10 Overview of all 2-12 Entering numerical values.

3 2-19 Therapy 2-22 Haemodialysis (HD) .. 2-22 Isolated ultrafiltration (ISO UF) .. 2-22 Haemofiltration (HF/HF-online).. 2-23 Haemodiafiltration (HDF/HDF-online) .. 2-23 Methods of treatment .. 2-24 Double-needle procedure .. 2-24 Single-needle procedure .. 2-24 Single-needle cross-over procedure .. 2-24 Single-needle valve procedure .. 2-26 Effectiveness of Dialysis (Kt/V).. 2-27 Using the timer/stop 2-28 Table of contents Dialog + IV IFU 38910173 / Rev. / May 2010 3 Installation and commissioning .. 3-3 Scope of supply .. 3-3 Storage .. 3-3 Storage in originally packed condition ..3-3 Interim storage of devices ready for Decommissioning ..3-3 Transportation .. 3-4 Wheeling ..3-4 Carrying ..3-5 Installation 3-6 Electrical connection.

4 3-6 Protection against water damage ..3-6 Potentially explosive areas ..3-6 Water 3-7 Quality of water and Disposal of used Initial commissioning .. 3-8 Setting date and 3-8 Switching on and off .. 3-9 4 Preparing for 4-3 Calling up haemodialysis .. 4-4 Automatic 4-4 Operation during automatic Terminating the automatic test Completion of automatic test sequence ..4-6 Reduction of warning sounds during Preparation .. 4-6 Connecting the concentrate .. 4-8 Setting the rinsing 4-9 Inserting and rinsing the tube system .. 4-11 Inserting the tube 4-11 Rinsing and testing the tube 4-14 Level regulation .. 4-14 Preparing the heparin pump .. 4-16 Inserting the heparin 4-16 Venting the heparin 4-17 Setting the treatment parameters .. 4-18 Setting the dialysate parameters .. 4-19 Monitoring the dialysate .. 4-21 Setting the ultrafiltration parameters.

5 4-21 Setting the pressure limits .. 4-23 Setting the heparin 4-25 Rinsing the 4-27 Stand-by mode .. 4-28 Activating the stand-by mode .. 4-28 Dialog + Table of contents IFU 38910173 / Rev. / May 2010 V Switching off the stand-by mode .. 4-28 Power failure in Preparation .. 4-29 5 Initiating haemodialysis .. 5-3 Checking the patient 5-3 Connecting the patient and starting 5-4 Level regulation ..5-5 During haemodialysis .. 5-7 Monitoring the blood-side pressure limits ..5-7 Treatment at minimum UF rate ..5-9 Heparin bolus .. 5-10 Arterial 5-10 Graphical representation of treatment parameters (trend).. 5-12 Interrupting the haemodialysis (bypass) .. 5-15 Completion of 5-15 Terminating treatment .. 5-15 Continuing treatment .. 5-15 6 End of haemodialysis therapy .. 6-3 Reinfusion .. 6-3 Emptying the dialyser .. 6-5 Emptying the cartridge after 6-5 Overview of the therapy carried 6-6 7 Disinfection.

6 7-3 Procedure and 7-3 Preparing for disinfection .. 7-4 Positioning the disinfectant container ..7-4 Selecting the disinfection program ..7-5 Automatic switch-off and 7-6 Automatic switch-off after disinfection ..7-6 Automatic switch-off and restarting ..7-6 Chemical 7-8 Short chemical disinfection .. 7-9 Thermal disinfection .. 7-9 Disinfection of incoming water from water 7-10 Chemical disinfection with disinfecting solution from central water supply .. 7-11 Automatic chemical disinfection with disinfectant from central water supply .. 7-12 Thermal disinfection with hot permeate from central water supply .. 7-14 Rinsing the permeate 7-15 Checking for disinfectant 7-16 Table of contents Dialog + VI IFU 38910173 / Rev. / May 2010 7-17 Terminating 7-17 Disposal of old Dialysis appliance.

7 7-18 8 HDF-online/HF-online .. 8-3 Preparing for haemodiafiltration/haemofiltration .. 8-4 Calling up haemodiafiltration/haemofiltration ..8-4 Connecting the concentrate ..8-4 Entering the substitution parameters ..8-5 Inserting the tube Filling and rinsing the tube system with substitution solution from the online system ..8-7 Inspecting the tube system .. 8-10 Preparing for standard haemodialysis with online fluid .. 8-10 Carry out 8-11 Connect patient and start 8-11 During haemodiafiltration/haemofiltration .. 8-13 Finish 8-15 Reinfusion with substitution solution .. 8-15 Emptying the dialyser .. 8-17 8-17 Regular disinfection .. 8-17 Displaying the online filter data .. 8-17 Changing the online filter .. 8-18 Sampling of substitution fluid .. 8-21 9 Single-needle procedure .. 9-3 Single-needle cross-over (SN-CO) .. 9-3 Preparing the therapy.

8 9-3 Level regulation ..9-5 Running the therapy ..9-7 Ending the therapy ..9-8 Single-needle valve (SN-valve) .. 9-9 Preparing the therapy ..9-9 Running the therapy .. 9-11 Ending the therapy .. 9-12 10 Use of options ..10-3 ABPM blood pressure 10-3 Cuff .. 10-3 Settings .. 10-5 Start/stop measurement .. 10-8 Showing and graphically displaying measured values .. 10-8 bioLogic RR Comfort - automatic blood pressure stabilisation with the guideline method ..10-10 Mode of operation ..10-10 Dialog + Table of contents IFU 38910173 / Rev. / May 2010 VII Setting of systolic blood pressure lower limit (SLL) and maximum ultrafiltration rate ..10-12 Setting of suggested systolic blood pressure lower limit (SLL)..10-14 Activating/deactivating bioLogic RR Graphical representation of ultrafiltration and blood pressure Setting the Graphic representation during therapy.

9 10-18 Kt/V Bicarbonate cartridge holder ..10-22 Inserting the Changing the cartridge during Emptying the cartridge after Dialysis ..10-23 Central concentrate supply ..10-24 Dialysis fluid Use and mode of Changing Dialysis fluid Resetting the data ..10-29 Sampling of Dialysis fluid ..10-31 Emergency power supply/battery ..10-33 Charging indicator ..10-34 Automatic battery test ..10-34 End of battery Communication interfaces ..10-35 BSL (Bed Side Link) ..10-35 DialogP+P-computer interface (DCI) ..10-35 Staff call ..10-35 Crit-Line Interface ..10-36 Set-up and connection with the DialogP+ Graphical presentation of Reading of the data from the patient therapy card ..10-42 11 Configuration .. 11-3 Configuring weekly disinfection program .. 11-3 Configuring profiles .. 11-6 Basic principles .. 11-6 Setting profile parameters.

10 11-6 UF 11-8 Select UF profiles .. 11-8 UF profile table ..11-10 Patient therapy card ..11-15 Erasing data from patient therapy card ..11-15 Entering the patient name ..11-16 Reading patient data ..11-17 Storing patient data (parameter settings) ..11-17 Table of contents Dialog + VIII IFU 38910173 / Rev. / May 2010 Entering parameters for computing the effectiveness of the Adjusting the monitor Select language of screen text ..11-24 Edit parameter of trend 12 Maintenance and External cleaning .. 12-3 Preventive maintenance and technical safety 12-4 Regular preventive 12-4 Technical safety 12-5 Accessories, disposable items and expendable 12-5 Technical service and warranty .. 12-5 12-5 Disposal of old Dialysis 12-5 13 Alarms and remedial action.