Instructions for Use
291 Pages
Preview
Page 1
+
Dialog Dialysis Machine Instructions for Use SW 9.0x
CE marking according to directive 93/42/EEC Technical alterations reserved B. Braun Avitum AG 34209 Melsungen, Germany Tel +49 (56 61) 71-3716 Fax +49 (56 61) 75-3716 IFU 38910173 / Rev. 2.02 / May 2010
www.bbraun.com
Dialog
+
Overview 1
Safe handling
1
2
Product description
2
3
Installation and commissioning
3
4
Preparing for haemodialysis
4
5
Initiating haemodialysis
5
6
End of haemodialysis therapy
6
7
Disinfection
7
8
HDF-online/HF-online
8
9
Single-needle procedure
9
10
Use of options
10
11
Configuration
11
12
Maintenance and cleaning
12
13
Alarms and remedial action
13
14
Accessories
14
15
Technical data
15
16
Appendix
16
Table of contents
II
Dialog
IFU 38910173 / Rev. 2.02 / May 2010
+
Dialog
+
Table of contents Table of contents 1
2
Safe handling ... 1-3 1.1
About these instructions for use ... 1-3 1.1.1 Validity ...1-3 1.1.2 Target group ...1-3 1.1.3 Warnings, notices and symbols in these instructions for use...1-4 1.1.4 Abbreviations ...1-5
1.2
Intended use and indication... 1-5
1.3
Contraindication... 1-6
1.4
Side effects ... 1-6
1.5
Special hazards and precautions... 1-6 1.5.1 Special patient conditions...1-6 1.5.2 Electrical hazards...1-7 1.5.3 Electromagnetic interactions ...1-7 1.5.4 Maintenance and filter change...1-8
1.6
Information for the operator ... 1-8 1.6.1 Training by manufacturer prior to commissioning...1-8 1.6.2 Requirements on the user ...1-8 1.6.3 Conformity ...1-9 1.6.4 Manufacturer’s responsibility...1-9 1.6.5 Technical changes... 1-10
1.7
Disposal and taking back of old dialysis machines... 1-10
Product description ... 2-3 2.1
Basic models... 2-3 2.1.1 Dialog+ single-pump machine...2-6 2.1.2 Dialog+ double-pump machine ...2-7 2.1.3 Dialog+ HDF-online...2-8
2.2
Symbols on the dialysis machine ... 2-9
2.3
Control elements and information on the monitor ... 2-10
2.4
Overview of all icons... 2-12
2.5
Entering numerical values ... 2-19
2.6
Therapy types... 2-22 2.6.1 Haemodialysis (HD) ... 2-22 2.6.2 Isolated ultrafiltration (ISO UF) ... 2-22 2.6.3 Haemofiltration (HF/HF-online)... 2-23 2.6.4 Haemodiafiltration (HDF/HDF-online) ... 2-23
2.7
Methods of treatment ... 2-24 2.7.1 Double-needle procedure ... 2-24 2.7.2 Single-needle procedure... 2-24 2.7.3 Single-needle cross-over procedure... 2-24 2.7.4 Single-needle valve procedure... 2-26
2.8
Effectiveness of dialysis (Kt/V)... 2-27
2.9
Using the timer/stop watch... 2-28
IFU 38910173 / Rev. 2.02 / May 2010
III
Table of contents
Dialog 3
4
+
Installation and commissioning ... 3-3 3.1
Scope of supply ... 3-3
3.2
Storage ... 3-3 3.2.1 Storage in originally packed condition...3-3 3.2.2 Interim storage of devices ready for operation...3-3 3.2.3 Decommissioning ...3-3
3.3
Transportation ... 3-4 3.3.1 Wheeling ...3-4 3.3.2 Carrying ...3-5
3.4
Installation site... 3-6 3.4.1 Electrical connection ...3-6 3.4.2 Protection against water damage...3-6 3.4.3 Potentially explosive areas...3-6
3.5
Water supply... 3-7 3.5.1 Quality of water and dialysate...3-7 3.5.2 Disposal of used fluids...3-7
3.6
Initial commissioning ... 3-8
3.7
Setting date and time... 3-8
3.8
Switching on and off ... 3-9
Preparing for haemodialysis... 4-3 4.1
Calling up haemodialysis ... 4-4
4.2
Automatic test... 4-4 4.2.1 Operation during automatic test...4-5 4.2.2 Terminating the automatic test sequence...4-6 4.2.3 Completion of automatic test sequence ...4-6
4.3
Reduction of warning sounds during Preparation ... 4-6
4.4
Connecting the concentrate ... 4-8
4.5
Setting the rinsing parameters... 4-9
4.6
Inserting and rinsing the tube system ... 4-11 4.6.1 Inserting the tube system... 4-11 4.6.2 Rinsing and testing the tube system... 4-14 4.6.3 Level regulation ... 4-14
4.7
Preparing the heparin pump ... 4-16 4.7.1 Inserting the heparin syringe... 4-16 4.7.2 Venting the heparin line ... 4-17
4.8
Setting the treatment parameters ... 4-18 4.8.1 Setting the dialysate parameters ... 4-19 4.8.2 Monitoring the dialysate ... 4-21 4.8.3 Setting the ultrafiltration parameters ... 4-21 4.8.4 Setting the pressure limits ... 4-23 4.8.5 Setting the heparin parameters... 4-25
4.9
Rinsing the dialyser... 4-27
4.10 Stand-by mode ... 4-28 4.10.1 Activating the stand-by mode ... 4-28
IV
IFU 38910173 / Rev. 2.02 / May 2010
Dialog
+
Table of contents 4.10.2 Switching off the stand-by mode ... 4-28 4.11 Power failure in Preparation... 4-29
5
6
7
Initiating haemodialysis ... 5-3 5.1
Checking the patient data... 5-3
5.2
Connecting the patient and starting haemodialysis... 5-4 5.2.1 Level regulation ...5-5
5.3
During haemodialysis ... 5-7 5.3.1 Monitoring the blood-side pressure limits ...5-7 5.3.2 Treatment at minimum UF rate ...5-9 5.3.3 Heparin bolus ... 5-10 5.3.4 Arterial bolus... 5-10 5.3.5 Graphical representation of treatment parameters (trend)... 5-12 5.3.6 Interrupting the haemodialysis (bypass) ... 5-15
5.4
Completion of treatment... 5-15 5.4.1 Terminating treatment ... 5-15 5.4.2 Continuing treatment... 5-15
End of haemodialysis therapy ... 6-3 6.1
Reinfusion ... 6-3
6.2
Emptying the dialyser ... 6-5
6.3
Emptying the cartridge after dialysis... 6-5
6.4
Overview of the therapy carried out... 6-6
Disinfection ... 7-3 7.1
Procedure and disinfectants... 7-3
7.2
Preparing for disinfection ... 7-4 7.2.1 Positioning the disinfectant container ...7-4 7.2.2 Selecting the disinfection program ...7-5
7.3
Automatic switch-off and restarting... 7-6 7.3.1 Automatic switch-off after disinfection ...7-6 7.3.2 Automatic switch-off and restarting ...7-6
7.4
Chemical disinfection... 7-8
7.5
Short chemical disinfection ... 7-9
7.6
Thermal disinfection ... 7-9
7.7
Disinfection of incoming water from water supply... 7-10 7.7.1 Chemical disinfection with disinfecting solution from central water supply ... 7-11 7.7.2 Automatic chemical disinfection with disinfectant from central water supply ... 7-12 7.7.3 Thermal disinfection with hot permeate from central water supply ... 7-14 7.7.4 Rinsing the permeate inlet... 7-15
7.8
Checking for disinfectant residues... 7-16
IFU 38910173 / Rev. 2.02 / May 2010
V
Table of contents
Dialog 7.9
+
Decalcification... 7-17
7.10 Terminating disinfection ... 7-17 7.11 Disposal of old dialysis appliance ... 7-18
8
9
10
HDF-online/HF-online ... 8-3 8.1
Preparing for haemodiafiltration/haemofiltration ... 8-4 8.1.1 Calling up haemodiafiltration/haemofiltration...8-4 8.1.2 Connecting the concentrate ...8-4 8.1.3 Entering the substitution parameters ...8-5 8.1.4 Inserting the tube system...8-7 8.1.5 Filling and rinsing the tube system with substitution solution from the online system ...8-7 8.1.6 Inspecting the tube system... 8-10
8.2
Preparing for standard haemodialysis with online fluid ... 8-10
8.3
Carry out haemodiafiltration/haemofiltration... 8-11 8.3.1 Connect patient and start haemodiafiltration/haemofiltration... 8-11 8.3.2 During haemodiafiltration/haemofiltration ... 8-13
8.4
Finish haemodiafiltration/haemofiltration... 8-15 8.4.1 Reinfusion with substitution solution ... 8-15 8.4.2 Emptying the dialyser ... 8-17
8.5
Disinfection... 8-17 8.5.1 Regular disinfection ... 8-17 8.5.2 Displaying the online filter data... 8-17 8.5.3 Changing the online filter ... 8-18 8.5.4 Sampling of substitution fluid ... 8-21
Single-needle procedure ... 9-3 9.1
Single-needle cross-over (SN-CO) ... 9-3 9.1.1 Preparing the therapy...9-3 9.1.2 Level regulation ...9-5 9.1.3 Running the therapy ...9-7 9.1.4 Ending the therapy ...9-8
9.2
Single-needle valve (SN-valve) ... 9-9 9.2.1 Preparing the therapy...9-9 9.2.2 Running the therapy ... 9-11 9.2.3 Ending the therapy ... 9-12
Use of options ...10-3 10.1 ABPM blood pressure monitoring... 10-3 10.1.1 Cuff ... 10-3 10.1.2 Settings... 10-5 10.1.3 Start/stop measurement ... 10-8 10.1.4 Showing and graphically displaying measured values... 10-8 10.2 bioLogic RR® Comfort - automatic blood pressure stabilisation with the guideline method ...10-10 10.2.1 Mode of operation...10-10
VI
IFU 38910173 / Rev. 2.02 / May 2010
Dialog
+
Table of contents 10.2.2 Setting of systolic blood pressure lower limit (SLL) and maximum ultrafiltration rate ...10-12 10.2.3 Setting of suggested systolic blood pressure lower limit (SLL)...10-14 10.2.4 Activating/deactivating bioLogic RR® Comfort...10-14 10.2.5 Graphical representation of ultrafiltration and blood pressure progression...10-15 10.3 Adimea...10-17 10.3.1 Setting the parameters...10-17 10.3.2 Graphic representation during therapy ...10-18 10.3.3 Kt/V table...10-21 10.4 Bicarbonate cartridge holder ...10-22 10.4.1 Inserting the cartridge...10-22 10.4.2 Changing the cartridge during dialysis...10-23 10.4.3 Emptying the cartridge after dialysis ...10-23 10.5 Central concentrate supply ...10-24 10.6 Dialysis fluid filter...10-25 10.6.1 Use and mode of operation...10-25 10.6.2 Changing dialysis fluid filter...10-26 10.6.3 Resetting the data ...10-29 10.6.4 Disinfection...10-30 10.6.5 Sampling of dialysis fluid ...10-31 10.7 Emergency power supply/battery ...10-33 10.7.1 Charging indicator...10-34 10.7.2 Automatic battery test ...10-34 10.7.3 End of battery operation...10-35 10.8 Communication interfaces ...10-35 10.8.1 BSL (Bed Side Link) ...10-35 10.8.2 DialogP+P-computer interface (DCI) ...10-35 10.8.3 Staff call ...10-35 10.9 Crit-Line Interface ...10-36 10.9.1 Function...10-36 10.9.2 Set-up and connection with the DialogP+P ...10-38 10.9.3 Setting...10-39 10.9.4 Graphical presentation of trends...10-41 10.9.5 Reading of the data from the patient therapy card ...10-42
11
Configuration ... 11-3 11.1 Configuring weekly disinfection program ... 11-3 11.2 Configuring profiles ... 11-6 11.2.1 Basic principles... 11-6 11.2.2 Setting profile parameters ... 11-6 11.3 UF profiles... 11-8 11.3.1 Select UF profiles ... 11-8 11.3.2 UF profile table ...11-10 11.4 Patient therapy card ...11-15 11.4.1 Erasing data from patient therapy card ...11-15 11.4.2 Entering the patient name ...11-16 11.4.3 Reading patient data ...11-17 11.4.4 Storing patient data (parameter settings)...11-17
IFU 38910173 / Rev. 2.02 / May 2010
VII
Table of contents
Dialog
+
11.5 Entering parameters for computing the effectiveness of the dialysis...11-18 11.6 Adjusting the monitor brightness...11-23 11.7 Select language of screen text ...11-24 11.8 Edit parameter of trend groups...11-25
12
Maintenance and cleaning...12-3 12.1 External cleaning ... 12-3 12.2 Preventive maintenance and technical safety inspection... 12-4 12.2.1 Regular preventive maintenance... 12-4 12.2.2 Technical safety inspection... 12-5 12.2.3 Accessories, disposable items and expendable parts... 12-5 12.3 Technical service and warranty ... 12-5 12.3.1 Warranty... 12-5 12.4 Disposal of old dialysis machines... 12-5
13
Alarms and remedial action ...13-3 13.1 Display and reset alarms... 13-3 13.2 Alarms and consequences... 13-5 13.2.1 Dialysis alarms ... 13-5 13.2.2 ABPM alarms...13-13 13.2.3 Crit-Line alarms...13-15 13.2.4 Level regulation alarms ...13-16 13.2.5 Adimea alarms ...13-17 13.2.6 bioLogic RR® Comfort alarms...13-18 13.2.7 Online alarms ...13-19 13.3 Remedying SAD alarms...13-21 13.4 Manual blood return...13-22 13.5 Omission of acoustic signals ...13-24 13.5.1 Omission of acoustic signals for alarm...13-24 13.5.2 Omission of acoustic signals for advice ...13-24
14
Accessories...14-3 14.1 Options ... 14-3 14.2 Mechanical accessories... 14-4 14.3 Other accessories... 14-4
15
Technical data ...15-3 15.1 General technical data... 15-3 15.2 Ambient conditions ... 15-4 15.3 Recommended safe distances ... 15-5 15.4 Dialysate system ... 15-6
VIII
IFU 38910173 / Rev. 2.02 / May 2010
Dialog
+
Table of contents 15.5 Extracorporeal circulation... 15-9 15.6 Materials coming into contact with water, dialysate, dialysis concentrates and/or disinfectants...15-11 15.7 Technical data HDF/HF-online...15-12 15.8 ABPM blood pressure monitoring...15-13 15.9 Technical data of Crit-Line interface ...15-14
16
Appendix... 16-3 16.1 Flow diagrams... 16-3 16.1.1 Key to flow diagrams ... 16-3 16.1.2 Flow diagram Dialog+... 16-5 16.1.3 Flow diagram Dialog+ HDF-online ... 16-6 16.2 Technical safety inspection and preventive maintenance ... 16-7
IFU 38910173 / Rev. 2.02 / May 2010
IX
Table of contents
X
Dialog
IFU 38910173 / Rev. 2.02 / May 2010
+
Dialog+
Safe handling
1
Table of contents
1
Safe handling ... 1-3 1.1
About these instructions for use ... 1-3 1.1.1 Validity ...1-3 1.1.2 Target group ...1-3 1.1.3 Warnings, notices and symbols in these instructions for use...1-4 1.1.4 Abbreviations ...1-5
1.2
Intended use and indication... 1-5
1.3
Contraindication... 1-6
1.4
Side effects ... 1-6
1.5
Special hazards and precautions... 1-6 1.5.1 Special patient conditions...1-6 1.5.2 Electrical hazards...1-7 1.5.3 Electromagnetic interactions ...1-7 1.5.4 Maintenance and filter change...1-8
1.6
Information for the operator ... 1-8 1.6.1 Training by manufacturer prior to commissioning...1-8 1.6.2 Requirements on the user ...1-8 1.6.3 Conformity ...1-9 1.6.4 Manufacturer’s responsibility...1-9 1.6.5 Technical changes... 1-10
1.7
Disposal and taking back of old dialysis machines... 1-10
IFU 38910173 / Rev. 2.02 / May 2010
1-1
Dialog+
Safe handling
1
1-2
IFU 38910173 / Rev. 2.02 / May 2010
Dialog+
Safe handling 1
Safe handling
1.1
About these instructions for use
1
These instructions for use form an integral part of the dialysis machine. They describe the appropiate and safe use of the dialysis machine.
The dialysis machine must always be used in accordance with the instructions for use. Always keep the instructions for use at the dialysis machine for later use. Pass on the instructions for use to any future user of the dialysis machine.
1.1.1
Validity
Article numbers These instructions for use apply to Dialog+ dialysis machines with the following article numbers (REF): • 710200X • 710201X • 710207X X = Combination of options at the time of delivery. Software version These instructions for use apply to software version 9.0x (x = any).
1.1.2
Target group
The target group for these instructions for use is specialist medical staff. The dialysis machine may only be used by persons instructed for its appropiate operation.
IFU 38910173 / Rev. 2.02 / May 2010
1-3
Dialog+
Safe handling
1.1.3
1
Warnings, notices and symbols in these instructions for use
Warnings in these instructions for use point out particular hazards for users, patients, third parties and the dialysis machine. They also suggest measures that can be taken to avoid the respective hazard. There are three levels of warning notices:
Warning term
Meaning
DANGER
Imminent danger that can lead to death or serious injury if not avoided.
WARNING
Potentially imminent danger that can lead to death or serious injury if not avoided.
CAUTION
Potentially imminent danger that can lead to minor injuries or damage to equipment if not avoided.
The warning notices are highlighted in the following manner (see below example for a CAUTION warning):
CAUTION
Here, the type and source of the danger are listed and possible consequences if measures are not followed! ¾ This is the list of measures to prevent the hazard.
This is the list of important information, directly or indirectly relating to safety and the prevention of damage.
This is additional useful information concerning safe procedures, background information and recommendations.
¾ This symbol marks the instructions for action.
1-4
IFU 38910173 / Rev. 2.02 / May 2010
Dialog+
Safe handling
1.1.4 ABPM BPA BPV BSL CCS CO HD HDF HF HP ISO UF PA PBE PBS PV RDV SAD SAKA SAKV SN SN-CO TMP TSM UF
1.2
Abbreviations
1
Automatic blood pressure monitoring Arterial blood pump Venous blood pump Bed Side Link Central concentrate supply Cross-over Haemodialysis Haemodiafiltration Haemofiltration Heparin pump Isolated ultrafiltration Arterial pressure Blood-side entry pressure at dialysis machine Blood pump control pressure for single-needle procedure Venous pressure Venous red detector Safety air detector Arterial tube clamp Venous tube clamp Single-needle Single-needle cross-over Trans membrane pressure Technical support and maintenance mode Ultrafiltration
Intended use and indication
The dialysis machine can be used for implementing and monitoring haemodialysis treatments for patients with acute or chronic kidney failure. The system can be used for hospital, health centre, limited-care or home dialysis. Depending on the model, the following types of therapy can be carried out with the system: • Haemodialysis (HD) • Isolated ultrafiltration (ISO UF): Sequential therapy (Bergström) • Haemodiafiltration (HDF) • Haemofiltration (HF)
IFU 38910173 / Rev. 2.02 / May 2010
1-5
Dialog+
Safe handling
1
1.3
Contraindication
There are no known contraindications for chronic haemodialysis. The doctor in charge of the treatment is responsible for choosing the suitable therapy, based on medical and analytical findings and the general health and condition of the patient.
1.4
Side effects
Hypotonia, nausea, vomiting and cramps are possible side effects. Oversensitive reactions caused by using the necessary tubing and filter materials have been observed in only few cases. For this matter, please refer to the product information provided with the consumables.
1.5
Special hazards and precautions
1.5.1
Special patient conditions
The dialysis system may only be operated on doctor´s instructions if the patient suffers from one of the following conditions: • Unstable circulation • Hypokalemia
WARNING
1-6
Dialysis for patients with a body weight of less than 30 kg requires a wider safety concept than that applicable to heavier patients. The special risks concern excessive blood loss, excessive blood flow and a disproportionately large extracorporeal blood volume compared to the blood volume of the patient! ¾ Special precautions are required, e. g. intensified monitoring of the patient. ¾ The dialysis machine must not be employed without qualification and adjustment of the entire therapy concept to the special conditions of the patient. Especially, the compatibility of individual consumables with each other and with the dialysis system must be considered.
IFU 38910173 / Rev. 2.02 / May 2010
Dialog+
Safe handling
1.5.2
Electrical hazards
1
The dialysis machine contains life-threatening electrical voltages.
WARNING
Risk of electric shock and fire. ¾ Always insert mains plug completely into the mains socket. ¾ Always pull/push on the plug not on the mains cord to connect or disconnect the mains plug. ¾ Avoid damage of the mains cord for example by running over it with the machine. It must not be used or connected to mains voltage if the housing or the mains cord is damaged in any way. A damaged dialysis machine must be submitted for repairs or disposed of. Interaction with other devices When using the dialysis machine in combination with other therapeutic devices of protection class I, a potential equalisation device must be connected, since the leakage currents from all connected devices are additive and the electrostatic discharge from the environment to Dialog+ may occur. Do not connect customary consumer devices to the same power socket as the dialysis machine or to connect them in parallel. Use with central-venous catheter For cardiac application, a higher degree of protection against electric shock is required. Electric currents can run through supply lines via the dialysis fluid filter, the dialyser, the catheter, the patient and every conducting object in the vicinity of the patient. That is why electrical potential equalisation must be provided. As soon as earth potential equalisation is connected to the machine the patient leakage current has to be below 10 µA, which complies with the limit value for patient leakage current of type CF. A special potential equalisation cable is available. It can be connected to the bolt at the rear side of the machine. The ambient conditions of the premises must be in accordance to the local requirements (see chapter 1.6.4). 1.5.3
Electromagnetic interactions
The dialysis machine has been developed and tested in accordance with the valid standards for interference suppression and electromagnetic compatibility (EMC). However, it cannot be guaranteed that no electromagnetic interaction with other devices will occur (examples: mobile phones, computer tomograph (CT)).
CAUTION
Risk of electrostatic discharge from other devices. ¾ It is recommended that mobile phones and other devices emitting strong electromagnetic radiation only be used at a minimum distance, according to IEC 60601-1-2 (see also chapter 15.3).
IFU 38910173 / Rev. 2.02 / May 2010
1-7
Dialog+
Safe handling
1
Placing other therapeutic or diagnostic medical devices on Dialog+ or near by or use of non-medical devices directly near the Dialog+ can influence electromagnetic interactions. In this case the user must observe the Dialog+ and all other machines to assure their correct operation.
1.5.4
Maintenance and filter change
In order to protect patients against cross-contamination, the transducer protectors of the tube systems to be used are equipped with hydrophobic 0.2-µm filters. If, despite this protective measure, blood enters into the machine-side transducer protectors/pressure sensors, the dialysis machine may only be used again after appropriate cleaning and disinfection was carried out by technical service. Due to the particularly stringent hygienic requirements, we recommend annual servicing of dialysis machines with dialysis fluid filters and of Dialog+ HDF-online. The dialysis fluid filters must be changed as specified in the respective instructions for use.
1.6
Information for the operator
1.6.1
Training by manufacturer prior to commissioning
The operator may only use the device after the manufacturer has trained the responsible staff based on these instructions for use. 1.6.2
Requirements on the user
The dialysis machine may only be used by persons instructed for its appropriate operation. The operator must ensure that the instructions for use are read and understood by all operators of the dialysis machine. Prior to using the dialysis machine, check for safe functioning and correct condition of the dialysis machine.
1-8
IFU 38910173 / Rev. 2.02 / May 2010