Manual de operación Fresenius 4008S
Short Description
Manual de operación de equipo de diálisis Fresenius 4008S en inglés...
Description
4008 S Hemodialysis Machine Operating Instructions Software Version 4.1 0123
Fresenius Medical Care
Operating Instructions 4008 S These Operating Instructions have been updated to
11/02.01 = 11th edition, February 2001 To save costs, only pages which have been corrected will be replaced. Refer to the table below to verify that the Operating Instructions are up-to-date.
Page(s)
Current version
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11/02.01
2-1 – 2-50
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3-1 – 3-40
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4-1 – 4-46
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5-1 – 5-22
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Part No.: M32 327 1
Fresenius Medical Care 4008 S 11/02.01 (OP)
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Fresenius Medical Care 4008 S 11/02.01 (OP)
OPERATING INSTRUCTIONS HEMODIALYSIS MACHINE 4008 S These Operating Instructions are part of the machine documentation and thus an integral part of the 4008 S hemodialysis machine. They contain any information necessary for the use of the 4008 S hemodialysis machine. Before operating the machine, the operator must have been instructed by the manufacturer on how to use the machine and must be thoroughly familiar with the contents of the Operating Instructions. The machine may only be operated by persons who have been instructed on the proper operation and handling of the unit. The Operating Instructions must be carefully studied before attempting to operate the machine. The Brief Operating Instructions are intended as a reference only and do not replace the Operating Instructions manual with which the operator must be fully familiar. Explanation of symbols used in the Operating Instructions:
☞
Note Informs the operator that in case of a failure to follow the steps as described, a specific function will be executed incorrectly or will not be executed at all, or will not produce the desired effect.
Caution Advises the operator against certain procedures or actions that could cause damage to the equipment or may have adverse effects on operators and patients.
The parameters entered must be verified by the operator, i.e. the operator must check, if the values entered are correct. Should the desired value deviate from the parameters displayed, the setting must be corrected before activating the function. The actual values displayed must be compared with the desired values specified! The 4008 S hemodialysis machine reflects the latest state of technology and complies with the regulations of EN 60601-1 (IEC 601-1). The 4008 S hemodialysis machine is classified as Class IIb equipment (MDD). Assembly, extensions, adjustments, modifications or repairs may only be carried out by the manufacturer or persons authorized by him. Please send any inquiries to (see next page):
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Manufacturer: Fresenius Medical Care AG D-61346 Bad Homburg Tel.: 0049 (0) 61 72/ 6 09-0
Local Service:
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Fresenius Medical Care 4008 S 11/02.01 (OP)
Table of Contents Chapter
Page
0
General Notes ................................................................................................................
0-
1 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 1.10 1.11 1.12 1.13 1.14 1.15 1.16
General Machine Description ...................................................................................... Intended Use ................................................................................................................... Transportation and Storage ............................................................................................ Structure and Function of Individual Machine Components .......................................... Description of the Procedure .......................................................................................... Description of the Extracorporeal Blood Circuit ............................................................. Initial Start-Up ................................................................................................................. Menu Description ............................................................................................................ Cleaning Programs ......................................................................................................... Maintenance ................................................................................................................... Disposables and Consumables ...................................................................................... Technical Data ................................................................................................................ Definitions and Terms ..................................................................................................... Abbreviations and Symbols ............................................................................................ Technical Safety Checks ................................................................................................ Certificates ...................................................................................................................... Literature .........................................................................................................................
11-5 1-9 1-12 1-36 1-53 1-59 1-73 1-90 1-93 1-93 1-103 1-117 1-120 1-121 1-123 1-132
2 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8
Preparation .................................................................................................................... Dialysis Machine ............................................................................................................. Functional Check ............................................................................................................ Blood Pump .................................................................................................................... Heparin Pump ................................................................................................................. Air Detector ..................................................................................................................... Extracorporeal Blood Circuit ........................................................................................... Priming the Extracorporeal Blood Circuit With a Saline Bag ......................................... Dialysate Side .................................................................................................................
22-3 2-12 2-26 2-28 2-32 2-34 2-36 2-41
3 3.1 3.2 3.3 3.4 3.5 3.6 3.7
Treatment ....................................................................................................................... Ultrafiltration .................................................................................................................... Double Needle Dialysis ................................................................................................... Single-Needle Dialysis .................................................................................................... Single-Needle Click-Clack .............................................................................................. Isolated Ultrafiltration ISO UF ......................................................................................... Sodium and UF Profiles .................................................................................................. DIASAFE ®plus (option) .....................................................................................................
33-3 3-11 3-18 3-23 3-25 3-30 3-39
4 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9
Alarm Processing ......................................................................................................... Management of Alarm Limits .......................................................................................... Needle Adjustment .......................................................................................................... Blood Alarms ................................................................................................................... Dialysate Alarms ............................................................................................................. Warnings ......................................................................................................................... Emergency Operation ..................................................................................................... Error Messages During Cleaning Programs ................................................................... Error Messages After Turning Power On ........................................................................ Error Messages When Using the Download Function ...................................................
44-3 4-6 4-8 4-26 4-29 4-35 4-37 4-44 4-45
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Chapter
Page
5 5.1 5.2 5.3 5.4 5.5
Disconnection ............................................................................................................... End of Treatment ............................................................................................................ Reinfusion ....................................................................................................................... Stopping Treatment ........................................................................................................ Emptying the bibag® (option) .......................................................................................... Emptying the Dialyzer .....................................................................................................
55-3 5-6 5-11 5-18 5-20
6 6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9
Cleaning ......................................................................................................................... General Overview ........................................................................................................... External Cleaning ........................................................................................................... Basic Conditions for Cleaning Programs ........................................................................ Disinfection, Decalcification ............................................................................................ Cleaning / Degreasing Program ..................................................................................... Hot Rinse ........................................................................................................................ Rinsing ............................................................................................................................ Priming During Cleaning Programs ................................................................................ Precirculation During the Cleaning Programs .................................................................
66-3 6-5 6-5 6-6 6-11 6-15 6-18 6-22 6-27
7 7.1 7.2 7.3 7.4
Special Menu Functions ............................................................................................... Changing the DIASAFE®plus (option) on Machines with Basic Hydraulics ..................... Changing the DIASAFE®plus (option) on Machines with Advanced Hydraulics .............. bibag® (option) ................................................................................................................ Transferring Treatment Parameters (Download) ...........................................................
77-3 7-7 7-17 7-22
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Table of Contents 1 General Machine Description Chapter
Page
1.1 1.1.1 1.1.2 1.1.3 1.1.4 1.1.5
Intended Use ................................................................................................................. Fields of Application ........................................................................................................ Side Effects ..................................................................................................................... Contraindications ............................................................................................................ General Description ........................................................................................................ Accessories .....................................................................................................................
1-5 1-5 1-5 1-5 1-6 1-8
1.2 1.2.1 1.2.2
Transportation and Storage ......................................................................................... Transportation ................................................................................................................. Storage ...........................................................................................................................
1-9 1-9 1-11
1.3
Structure and Function of Individual Machine Components ................................... Fig.: Hemodialysis Machine – front view ........................................................................ Fig.: Hemodialysis Machine – rear view ......................................................................... Monitor ............................................................................................................................ Fig.: Hemodialysis Machine – monitor front .................................................................... Fig.: Hemodialysis Machine – monitor rear and power supply unit ............................... Modules .......................................................................................................................... Fig.: Blood pump (arterial) .............................................................................................. Fig.: Heparin pump ......................................................................................................... Fig.: Air detector ............................................................................................................. Fig.: Flow diagram of basic hydraulics incl. DIASAFE ®plus (option) ............................... Description of the Basic Hydraulics incl. DIASAFE ®plus (option) .................................... Fig.: Flow diagram 4008 S with advanced hydraulics .................................................... Description of the Advanced Hydraulics ......................................................................... Central Delivery System (CDS) – optional ......................................................................
1-12 1-12 1-13 1-14 1-14 1-16 1-18 1-18 1-19 1-20 1-22 1-24 1-26 1-28 1-30
Description of the Procedure ...................................................................................... Description of Bicarbonate Dialysis ................................................................................ Fig.: Concentrate connectors .......................................................................................... Fig.: Preparation of the dialysate (schematic) Fig.: for 4008 dialysis machines with basic hydraulics .................................................. Fig.: Preparation of the dialysate (schematic) Fig.: for 4008 dialysis machines with advanced hydraulics ........................................... Description of the Variation Function .............................................................................. Fig.: Possibilities of combining sodium and UF profiles ................................................ Description of DIASAFE®plus (option) with Basic Hydraulics .......................................... Fig.: System components ............................................................................................... Fig.: Filter test procedure ................................................................................................ Fig.: Dialysis procedure .................................................................................................. Fig.: Cleaning procedure ................................................................................................ Description of DIASAFE®plus (option) with Advanced Hydraulics ................................... Fig.: System components ............................................................................................... Fig.: Membrane integrity test procedure (DIASAFE®plus) ............................................... Fig.: Dialysis procedure .................................................................................................. Fig.: Cleaning procedure ................................................................................................
1-36 1-36 1-38
1.3.1
1.3.2
1.3.3 1.3.4 1.3.5 1.4 1.4.1
1.4.2 1.4.3
1.4.4
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1-1
Chapter 1.5
Page Description of the Extracorporeal Blood Circuit ...................................................... Fig.: Extracorporeal blood circuit – double needle dialysis ............................................ Double Needle Dialysis ................................................................................................... Single Needle Click-Clack Dialysis ................................................................................. Fig: Extracorporeal blood circuit – single needle dialysis (optional) .............................. Single Needle Dialysis (optional) .................................................................................... Effective Blood Flow and Accumulated Blood Volume .................................................. Fig.: Blood pump (SN) ....................................................................................................
1-53 1-53 1-54 1-54 1-55 1-56 1-57 1-58
1.6 1.6.1 1.6.2 1.6.3 1.6.4
Initial Start-Up ............................................................................................................... Relevant Instructions Before Initial Start-Up ................................................................... How to Connect the Hemodialysis Machine ................................................................... Inserting / Priming the DIASAFE®plus (option) on Machines with Basic Hydraulics ....... Inserting / Priming the DIASAFE®plus (option) on Machines with Advanced Hydraulics
1-59 1-59 1-63 1-66 1-69
1.7 1.7.1
Menu Description .......................................................................................................... General Notes ................................................................................................................. Fig.: Data entry fields ...................................................................................................... Fig.: Screen (e.g. Ultrafiltration menu) ............................................................................ Fig.: Screen (e.g. Dialysate menu) ................................................................................. Using the Menus – Examples ......................................................................................... Menu Description ............................................................................................................ Description of Messages Displayed in the Menus .........................................................
1-73 1-73 1-73 1-74 1-75 1-76 1-79 1-88
1.8 1.8.1 1.8.2
Cleaning Programs ....................................................................................................... General Information on the Cleaning Programs ............................................................ Disinfection and Removal of Calcium Deposits ............................................................. Fig.: Disinfection flow chart .............................................................................................
1-90 1-90 1-91 1-92
1.9
Maintenance ..................................................................................................................
1-93
1.10 1.10.1 1.10.2 1.10.3 1.10.4
Disposables and Consumables ................................................................................... Disposables .................................................................................................................... Consumables .................................................................................................................. DIASAFE®plus (option) ..................................................................................................... Part Numbers ..................................................................................................................
1-93 1-93 1-95 1-100 1-101
1.11 1.11.1 1.11.2 1.11.3 1.11.4 1.11.5 1.11.6 1.11.7 1.11.8 1.11.9 1.11.10 1.11.11 1.11.12
Technical Data ............................................................................................................... Dimensions, Weight and Housing Material ..................................................................... Electrical Safety ............................................................................................................. Electrical Supply ............................................................................................................. Type Label ...................................................................................................................... Fuses .............................................................................................................................. Operating Conditions ...................................................................................................... Optional External Connections ....................................................................................... Override Conditions ........................................................................................................ Operating Programs ........................................................................................................ Dialysate Circuit and Safety Systems ............................................................................. Extracorporeal Blood Circuit and Safety Systems ......................................................... Environmental Compatibility and Recycling....................................................................
1-103 1-103 1-103 1-104 1-104 1-105 1-105 1-106 1-107 1-108 1-109 1-113 1-115
1.12
Definitions and Terms ..................................................................................................
1-117
1.13 1.13.1 1.13.2
Abbreviations and Symbols ......................................................................................... Abbreviations .................................................................................................................. Symbols ..........................................................................................................................
1-119 1-119 1-120
1.5.1 1.5.2 1.5.3 1.5.4
1.7.2 1.7.3 1.7.4
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Chapter
Page
1.14
Technical Safety Checks ..............................................................................................
1-121
1.15 1.15.1 1.15.2 1.15.3 1.15.4 1.15.5 1.15.6 1.15.7
Certificates .................................................................................................................... CE Declaration of Conformity for 4008 B ........................................................................ CE Declaration of Conformity for 4008 S (option) ......................................................... CE Declaration of Conformity for Diasafe ®plus (option) .................................................. CE Declaration of Conformity for bibag® (option) .......................................................... ISO 9001 (EN 46001) Certificate .................................................................................... EN ISO 14001 Certificate ............................................................................................... EC Certificate ..................................................................................................................
1-123 1-123 1-124 1-125 1-126 1-127 1-128 1-130
1.16 1.16.1 1.16.2 1.16.3
Literature ....................................................................................................................... Hemodialysis in General ................................................................................................. Dialysate Filter and ON-LINE HDF ................................................................................. Blood Temperature Monitor (BTM) .................................................................................
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1.1
Intended Use
1.1.1
Fields of Application The 4008 H dialysis machine is designed for performing chronic and acute hemodialysis. It can be used in home dialysis, limited care centers and clinical hemodialysis.
1.1.2
Side Effects Dialysis therapy occasionally causes hypotension, nausea, vomiting and cramping in some patients. Please take note of the package inserts enclosed with the hemodialysis concentrates, dialyzers, etc.
1.1.3
Contraindications – Hyperkalemia (for potassium-containing hemodialysis concentrates only) – Hypokalemia (for potassium-free hemodialysis concentrates only) – Uncontrollable coagulation anomalies A different method of extracorporeal treatment may be indicated in hemodynamically unstable patients.
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1.1.4
General Description The hemodialysis machine allows dialysis treatments without any additional equipment. The machine operates and monitors the dialysate circuit and the extracorporeal blood circuit. The required treatment parameters can be entered via various menus provided for programming and displayed on a high-resolution LC display. The current treatment data are shown on the display. In the dialysate circuit, purified water is mixed with hemodialysis concentrate, heated, degassed and delivered to the dialyzer. Inflowing and outflowing quantities are balanced volumetrically. The pressure at the dialyzer is adjusted depending on the ultrafiltration rate selected and the type of dialyzer used. The DIASAFE®plus option permits hemodialysis treatment with high-purity dialysate. The DIASAFE®plus option basically consists of one filter stage. For the entire time of its use the filter is an integral part of the hemodialysis machine and is rinsed and disinfected in conjunction with the machine. The integrity of the filter is tested by means of a pressure holding test which is integrated in the functional test of the hemodialysis machine. The filter can be used for a maximum of 100 treatments or for a period of 12 weeks, whichever comes first. Should the filter fail to pass the filter test, it must be replaced at an earlier date. For the use of this option, the quality of the water and the dialysate must comply with the applicable standards. (See Chapter 1.6 Initial Start-Up.) In the extracorporeal blood circuit, the blood is continuously heparinized and passes through the dialyzer. An air detector prevents infusion of air . Any dangerous loss of blood is prevented by a blood leak detector and a device monitoring the venous return pressure. The arterial pressure monitoring unit detects any intake of the needle in the vessel. The hemodialysis machine is designed for both acetate dialysis and bicarbonate dialysis. The mixing ratio of concentrate to purified water can be programmed (default setting 1+34 – selection of other mixing ratios is possible). Depending on the concentrate used, the Na+ concentration can be readjusted within a range of 125 to 150 mmol. The bicarbonate concentration can be readjusted within a range of ±8 mmol. With the bibag® option the bicarbonate solution is produced from a bag (sodium hydrogen carbonate powder, NaHCO3). The powder is diluted in the machine to obtain ready-to-use bicarbonate. Na+ and UF profiles can be programmed by using the built-in variation function. It is possible to perform ultrafiltration without dialysate flow (sequential dialysis/isolated ultrafiltration, ISO-UF).
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The dialysate flow is variable (3 levels: 300, 500, 800 ml/min). The basic version of the hemodialysis machine is designed for double needle dialysis. Freely selectable programs are available for cleaning and disinfecting the machine. The hemodialysis machine is equipped with all safety systems required for proper function and patient safety EN 60601-1 (IEC 601-1). The automatic test of the safety systems (functional test, also called T1 test) must be performed prior to each dialysis treatment. This test also checks the integrity of the closed system (pressure holding test PHT). In the following cases, the hemodialysis machine will request the user to perform the functional test: – after a start with external power supply (not power failure), – after one of the cleaning programs. For additional safety, cyclic pressure holding tests (CPHT) are also performed during the dialysis treatment to detect possible leakages in the closed system. The CPHT is performed automatically every 12.5 minutes. For the CPHT the dialysis machine is switched for a few seconds into bypass and ultrafiltration is stopped. Balancing is not affected by these CPHTs, but the effective dialysis time will be reduced by approx. 2 minutes per hour of treatment.
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1.1.5
Accessories
Caution Any additional equipment connected to the analog and digital interfaces of the machine must comply with the applicable EN specifications (e.g. EN 60950 for data processing equipment, and EN 60601 (IEC 601) for electro-medical equipment). Apart from this requirement, all configurations must comply with the system standard EN 60601-1-1 (IEC 601-1-1). The connection of additional equipment to the signal input or output component affects the system configuration and anyone connecting additional equipment is therefore responsible for compliance with the system standard EN 60601-1-1 (IEC 601-1-1).
● The hemodialysis machine can be supplied with the following modules: 1. A blood pump for performing single needle dialysis. 2. A heparin pump for the use of 50 ml syringes as well as a heparin pump for the use of 20 ml syringes. 3. An air detector for a 22 mm bubble catcher. ● The following accessories (options) are available: These accessories have been approved within the scope of an EC prototype test. 1. BPM 4008 Blood Pressure Monitor 2. DIASAFE®plus 3. ONLINEplus ™ 4. Interface Commco 5. CDS (central delivery system) 6. bibag ® 7. Status indicator ("traffic light") 8. BTM 4008 Blood Temperature Monitor 9. BVM 4008 Blood Volume Monitor 10. 4008 Remote Control 11. Arterial Clamp 12. Finesse 13. ON-LINE HDF (for dialysis machines without ONLINEplus ™ only) 14. 4008 HDF (for dialysis machines without ONLINEplus ™ only) 15. Water inlet filter 16. Rinsing the water supply hose (Flush) 17. OCM (Online Clearance Monitor)
[including separate Operating Instructions] [including separate Operating Instructions]
[including separate Operating Instructions] [including separate Operating Instructions] [including separate Operating Instructions] [including separate Operating Instructions] [including separate Operating Instructions] [including separate Operating Instructions]
[including separate Operating Instructions]
[including separate Operating Instructions]
● In addition, the following accessories are available: RO 08 (single-place reverse-osmosis system) [including separate Operating Instructions]
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1.2
Transportation and Storage
1.2.1
Transportation ● Inside buildings Lift the brake lever.
The hemodialysis machine can be tilted, turned or pushed in any direction.
To overcome uneven surfaces (e.g. elevator entry): Always push the hemodialysis machine slowly across uneven surfaces to avoid damage or prevent the machine from turning over.
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At least two persons are required for overcoming steps or stairs. Proceed as follows: Lock the brake. Clamp the vent tubing by means of arterial forceps. Tilt the machine. Lift the machine and transport it (never hold the machine at the IV pole or at one of the modules when lifting it). Put the machine down and set it up in reverse order.
● Outside buildings – Never push the hemodialysis machine across an uneven paving (e.g. cobblestone pavement). Always lift it. – When transporting the hemodialysis machine in vehicles, accommodate it vertically or horizontally and protect it with an appropriate padding. – When transporting the hemodialysis machine outside of buildings for a prolonged period of time, the range of storage temperature must be observed (if necessary, fill the machine with an antifreezing solution).
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1.2.2
Storage The hemodialysis machine must be stored vertically in a well-ventilated room with low variations in temperature. Storage temperature: – without antifreeze – with antifreeze
+5 °C up to +60 °C –20 °C up to +60 °C
When storing the hemodialysis machine with antifreeze, make sure to use antifreeze of the following composition: – 48.75 % water – 48.75 % glycerine – 2.5 % Teta-plus Charging the integrated batteries: Upon receipt of the hemodialysis machine, the integrated batteries must be charged as follows: – Connect the machine to the power supply system by means of the power cord. – Turn power on and leave the machine on for approx. 10 hours. If the machine is not in use, this procedure should be repeated every six months.
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1.3
Structure and Function of Individual Machine Components Fig.: Hemodialysis machine – front view 1
Fresenius Medical Care 4008 S Ein/Aus
Luftdetektor
Blutleck
Arterieller Venöser Druck Druck Reinigen
mmHg
TMP
mmHg
280
mmHg
500
500
400
400
300
300
200
200
100
100
0
0
200 SN
100 0
9
–100 –200 –300 Test Leitfähigk. mS/cm
Vorbereiten
15,5 15
Start/Reset
Fluß
UF
I/O
I/O
14,5 7
8
9
4
5
6
1
2
3
Esc
0
14 Ton aus
13,5 13
Dial. Flüssigk.
UF
Menü
Menü
Rate: ml/min (Ø: mm)
C
Best
Rate: ml/min (Ø: mm)
8
Pven.
Start Stop
Start Stop
2 Rate: ml/h (Bolus: ml)
(
:h.min)
Bolus
Rate Start Stop
2a
7
3
6 5
4 Legend 1 2
Monitor 3 Modules – Level 1 4 (from left to right) 5 Blood pump (arterial) 6 Blood pump (SN) 7 Air detector 8 2a Modules – Level 2 9 (from left to right) Heparin pump Rinse chamber, bibag®-Connector (option) not used
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Hydraulics Brake Bicarbonate suction tube (blue) Concentrate suction tube (red) Rinse chamber Interlock shunt for dialyzer connecting tubes IV pole
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Fig.: Hemodialysis machine – rear view
1
2
3
14
4 5 15
13
12
7
6
11 10 9 8
Legend 1 2 3 4 5 6 7 8
Monitor (rear) Sample collection valve Filter Dialyzer supply line with external flow indicator Dialyzer return line Disinfection connector Water inlet filter, optional Bicarbonate connector for central delivery system (blue), optional
9 10 11 12 13 14 15
Concentrate connector for central delivery system (red), optional Drain Water connector (permeate) or connector for water inlet filter DIASAFE ®plus (filter 1) option Vent tubing Power supply unit Holder for dialyzer connecting lines
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1.3.1
Monitor
Fig.: Hemodialysis machine – monitor front
Fresenius Medical Care 4008 S Air detector
On/Off
1b Cleaning
2a 2b SN
Venous Pressure
mmHg
mmHg
280
18c
9a
Arterial Pressure
10a
18b
Blood leak
8a
1a
18a
11a
TMP
12a
mmHg
500
500
400
400
300
300
200
200
100
100
0
0
200 100
3a
0
3b
19a
–100 –200 –300
10b
Test
4a
11b
12b
Conductivity
4b Prime
15a mS/cm 17a
15,5
5a 5b Start/Reset
6a
Flow
14a UF
15
On/Off
On/Off
14,5
17b
14b
6b Tone Mute
7a
1-14
7
8
9
4
5
6
1
2
3
Esc
0
14 13,5 Dialysate
UF
13
Menu
Menu
7b 15b
16a
13a
Fresenius Medical Care 4008 S
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20b C
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20c
20d 20e Conf
● Monitor front description The complex functions of the controls on the monitor are illustrated and explained in Chapter 2, where operation of the machine is described in detail.
Function keys (pos. 1 – 7)
Dialysate monitor (pos. 15 – 18)
1a 1b
On/Off key On/Off LED
15a 15b
Conductivity alarm indicator Conductivity display
2a 2b
Cleaning key Cleaning LED
16a
Dialysate Menu key
3a 3b
SN key SN LED
17a 17b
Flow LED Flow On/Off key
4a 4b
Test key Test LED
5a 5b
Prime key Prime LED
18a 18b 18c
6a 6b
Start/Reset key Start/Reset LED
Screen / data entry (pos. 19 – 20)
7a 7b
Tone Mute key Tone Mute LED
Blood monitor (pos. 8 – 12) and ultrafiltration unit (pos. 13 – 14) 8a
Air Detector alarm indicator
9a
Blood Leak alarm indicator
10a 10b
Arterial Pressure alarm indicator Arterial Pressure display
11a 11b
Venous Pressure alarm indicator Venous Pressure display
12a 12b
TMP alarm indicator TMP display
13a
UF Menu key
14a 14b
UF LED UF On/Off key
Status indicators (pos. 18) Green status indicator (operation) Yellow status indicator (warning/info) Red status indicator (alarm)
19a
Screen
20a 20b 20c 20d 20e
Numeric keys for data entry (0 to 9, +, –) C key Arrow keys ▲, ▼, and Esc key Conf key
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Fig.: Hemodialysis machine – monitor rear and power supply unit
1 2
3
4
5
6
7 8
9
10
11
15 16 17
14
1-16
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● Description of monitor rear panel and power supply unit
Caution Apart from the options mentioned on page 1-8, additional equipment should only be connected to the ports on the rear of the monitor if the resulting overall system complies with the requirements of EN 60601-1-1 (IEC 601-1-1), or if their applicability with regard to technical safety has been proven by a certificate issued by a testing agency authorized to test the ready-for-use machine.
1
Fan
2
Service switch
3
Audible alarm volume control
4
Connection socket for status indicator/traffic light (optional)
5
RS232 interface (galvanically decoupled by optocoupler) (optional)
6
Input/output port (for external equipment)
7
Screen socket
8
Time meter
9
ALARM IN port (for connection of an external pushbutton switch, which can be used to initiate a machine stop).
10
ALARM OUT port (for connection of an external alarm indicator, nurse call)
11
Symbols. Caution: consult accompanying documents.
12
Power supply unit (voltage supply for the hemodialysis machine)
13
Power switch (main switch)
14
Power cord (supplies the hemodialysis machine with line voltage, 230 V AC; 50 – 60 Hz)
15
Loudspeaker for audible alarm
16
Port for connection of the remote control (optional)
17
Key interface (patient identification in conjunction with FINESSE) (optional)
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1.3.2
Modules Fig.: Blood pump (arterial)
1
Rate: ml/min (Ø: mm)
2 3
11 10
4
Start Stop
9
8
7
6 5
● Description of the blood pump (arterial)
1-18
1
Display (indicates the delivery rate, the line diameter or an error code)
2
Alarm LED (red)
3
Operation LED (green)
4
Pressure connector (Luer-lock connector of the arterial pressure measuring line)
5
Clamping piece (holds the installed line segment securely in place)
6
Blood pump cover
7
Rotor (delivers the patient’s blood by means of the rollers and the present line set; the rotor can be removed for cleaning purposes)
8
Sensor (blood pump cover open or closed)
9
Start/Stop key (to turn the blood pump on and off)
10
▼ key (to reduce the delivery rate or the value of the line diameter)
11
▲ key (to increase the delivery rate or the value of the line diameter)
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Fig.: Heparin pump
12 Rate: ml/h (Bolus: ml)
1
11 (
:h.min)
2
Bolus
10 9
3
Rate
8 Start Stop
4
7 6
5
● Description of the heparin pump 1
Slide carriage (moves the syringe plunger)
2
Bolus key
3
Rate key (to set the delivery rate)
4
key (to set the stopwatch time)
5
Syringe holder
6
Stop-watch time indicator (green)
7
Start/Stop key (to turn the heparin pump on and off)
8
▼ key (to reduce the delivery rate or to decrement the stop-watch time, and to move the slide carriage down)
9
▲ key (to increase the delivery rate or to increment the stop-watch time, and to move the slide carriage up)
10
Power indicator (green)
11
Display (displays the delivery rate, the stop-watch time, the bolus amount or an error code)
12
Alarm indicator (red)
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Fig.: Air detector
Pven.
1 2
3
4 5
● Description of the air detector
1-20
1
Keys (to raise (▲) and lower (▼) the fluid level in the venous bubble catcher)
2
Venous pressure connector (Luer-lock connector of the venous pressure measuring line)
3
Holder for the venous bubble catcher with ultrasonic sensors
4
Venous line clamp
5
Optical detector
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Next page: Fig.: Flow diagram of basic hydraulics incl. DIASAFE®plus (option)
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Fig.: Flow diagram of basic hydraulics incl. DIASAFE®plus (option)
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Legend 2 3 5 6 7 8 9 10 12 21 22 23 24 24b 25 26 29 30 31 32 33 34 35 36 37 38 41 43 54 61 63 65 66 66a 66b 66c 68 71 72 73 74 75 76 77 78 84 85 86
Temperature sensor Temperature sensor Float switch Level sensor Conductivity cell Blood leak detector Pressure transducer Reed contact for concentrate Reed contact for bicarbonate Flow pump UF pump Concentrate pump Dialyzer valve 1 Dialyzer valve 2 Bicarbonate pump Bypass valve Degassing pump Outlet valve Balancing chamber valve 1 Balancing chamber valve 2 Balancing chamber valve 3 Balancing chamber valve 4 Balancing chamber valve 5 Balancing chamber valve 6 Balancing chamber valve 7 Balancing chamber valve 8 Water inlet valve Fill valve Heater rod Pressure reducing valve Water inlet filter Loading pressure valve Heater block Water inflow chamber Heater rod chamber Float chamber Balancing chamber Filter/concentrate Filter/bicarbonate Filter/dialysate ext. Filter/UF External flow indicator Filter/fill valve Heat exchanger Relief valve Disinfectant valve Disinfectant connector Recirculation valve
87 Drain valve 88 Multifunction block 88a Degassing chamber 88b Secondary air separator 88c Primary air separator 89 Degassing orifice 90a Rinse chamber concentrate 90b Rinse chamber bicarbonate 91 Rinse valve 92 Vent valve 94 Concentrate suction tube 95 Bicarbonate suction tube 97 Air separation pump 99 Rinse valve 100 Rinse valve 102 Central concentrate delivery valve 104 Central bicarbonate delivery valve 109 Temperature sensor 111 Hydrophobic filter 112 Vent valve 114 Dialysate filter 115 Sensor disinfection valve 116 Sampling valve 117 Check valve (concentrate) 118 Check valve (bicarbonate) 119 Filter (concentrate) 120 Filter (bicarbonate) 121 Central concentrate delivery connector 122 Central bicarbonate delivery connector 123 Pressure switch for V102 124 Pressure switch for V104 125 Temperature compensation plate 130 bibag ® drain valve 131 bibag ® block 131a bibag ® air sep. chamber 131b bibag ® mixing chamber 132 bibag ® conductivity cell 133 bibag ® temperature sensor 134 bibag ® pressure transducer 135 bibag ® level sensor 136 bibag ® connector 137 bibag ® microswitch 1 138 bibag ® microswitch 2 148 Filter/rinse valve 100 149 Filter/rinse valve 99 150 Filter 151 Orifice 210 Filter (degassing orifice)
Hydraulics measuring points A B C D
Reduced water inlet pressure Balancing chamber loading pressure Flow pump pressure Degassing pump pressure
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1.3.3
Description of the Basic Hydraulics incl. DIASAFE®plus (option) The hydraulic compartment of the hemodialysis machine consists of a volumetric dialysate balancing system, which is closed against the atmosphere. In the balancing chambers, the used dialysate is displaced by fresh dialysate (and vice versa). This assures that equal amounts of dialysate enter and exit the dialyzer. The fresh and the used dalysate are separated by an elastic membrane. The float switch (5) located in the heater block (66) controls the inflow of fresh water via the water inlet valve (41). The upstream pressure reducing valve (61) ensures a constant water inlet pressure. In the chamber (88c) of the multifunction block (88), the concentrate pump (23) adds acetatecontaining concentrate. During bicarbonate dialysis, it adds acid concentrate. When peforming bicarbonate dialysis the bicarbonate is pumped by the membrane pump (25) from the bicarbonate suction tube (95) via the air separation chamber (131a) into the chamber (88c) of the multifunction block (88) adding exact quantities of bicarbonate. The conductivity measuring cell (132) and the temperature sensor (133) measure and monitor the bicarbonate conductivity. The heat exchanger (77) transmits part of the heat of the outflowing dialysate to the cold inflowing water. The dialysate is heated in the heater rod chamber (66b). The degassing pump (29) and the orifice (89) generate a negative pressure for deaeration of the dialysate. The air removed is collected in the air separating chamber from where it passes to the heater block (66) via the loading pressure valve (65). The air is then discharged into the atmosphere via the float chamber (66c). The dialysate flows from the chamber (88c) via the mixing chamber (131b) to the balancing chamber (68) from where it passes through the conductivity measuring cell (7) and the dialyzer valve (24) to the dialyzer. In the conductivity cell (7), both the conductivity and the temperature (temperature sensor 3) are measured and indicated on the monitor. If temperature and conductivity are inside the alarm limits, the two dialyzer valves (24 and 24b) are open and the bypass valve (26) is closed. Should one of the two values be outside the alarm limits (temperature or CD alarm), the bypass valve (26) opens and the dialyzer valve (24) closes. The used dialysate coming from the dialyzer is monitored by a blood leak detector (8), from where it flows into the secondary air separator (88b) of the multifunction block (88). The fluid coming from this chamber is forced through the flow pump (21) into the balancing chamber (68). This ensures that the spent dialysate discharged by the dialyzer is always replaced by the same amount of fresh dialysate. The pressure transducer (9) is located in the secondary air separator (88b) of the multifunction block (88). The pressure measured here is taken as a quantity in the computation of the TMP. A membrane pump (UF pump 22) with a volume of 1 ml per stroke withdraws fluid from the system at a specified rate. Since the system is closed, the same volume of ultrafiltrate reflows from the blood via the dialyzer. After the balancing chamber (68), the used dialysate is directed to the drain via the valve (30), the heat exchanger (77) and the drain valve (87).
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Larger amounts of air entering the system, as a result of major deaeration or during priming, are detected by the level sensor (6). The air is discharged into the atmosphere via the air separation pump (97). The sampling valve (116) is located in the dialyzer inflow line. Here, dialysate can be withdrawn with a Luer-lock syringe. With the dialysate filter (114), the dialysate passes through a capillary filter with a polysulfone membrane and then flows to the dialyzer. The filter holds back pyrogenic substances and microorganisms. The pressure measuring points A, B, C, and D allow direct measurement of various pressures, without the need to separate lines and tubing. Measuring point A measures the water inlet pressure; B the loading pressure of the balancing chamber; C the pressure of the flow pump; and D the negative degassing pump pressure. During the hot rinse and disinfection programs, the machine is operated in recirculation mode. In this case, the drain valve (87) is closed and the recirculation valve (86) open. This method of recirculation serves to save energy (hot rinse) and disinfectant. The disinfectant is introduced into the circuit by the UF pump (22) via the disinfectant valve (84) and the sensor (115). The sensor (115) detects whether disinfectant is present or not. Rinsing the water supply hose (Flush) – option: The water supply hose is rinsed during the test phase (watchdog) each time the dialysis machine is turned on. For this rinse procedure a special valve, V-Flush, (parallel to V41) and a 2nd drain hose are required.
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Fig.: Flow diagram 4008 S with advanced hydraulics
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Legend 2 3 5 6 7 8 9 10 12 21 22 23 24 24b 25 26 29 30 31 32 33 34 35 36 37 38 39 41 43 54 61 63 65 66 66a 66b 66c 68 71 72 73 74 75 76 77 78 84 85 86 87 88 88a 88b 88c 89 90a 90b 91
Temperature sensor Temperature sensor Float switch Level sensor Conductivity cell Blood leak detector Pressure transducer Reed contact for concentrate Reed contact for bicarbonate Flow pump UF pump Concentrate pump Dialyzer valve 1 Dialyzer valve 2 Bicarbonate pump Bypass valve Degassing pump Outlet valve Balancing chamber valve 1 Balancing chamber valve 2 Balancing chamber valve 3 Balancing chamber valve 4 Balancing chamber valve 5 Balancing chamber valve 6 Balancing chamber valve 7 Balancing chamber valve 8 Negative pressure valve Water inlet valve Fill valve Heater rod Pressure reducing valve Water inlet filter Loading pressure valve Heater block Water inflow chamber Heater rod chamber Float chamber Balancing chamber Filter/concentrate Filter/bicarbonate Filter dialysate external Filter/UF External flow indicator Filter/fill valve Heat exchanger Relief valve Disinfectant valve Disinfectant connector Recirculation valve Drain valve Multifunction block Degassing chamber Secondary air separator Primary air separator Degassing orifice Rinse chamber, concentrate Rinse chamber, bicarbonate Rinse valve
92 Vent valve 94 Concentrate suction tube 95 Bicarbonate suction tube 97 Air separation pump 99 Rinse valve 100 Rinse valve 102 Central concentrate delivery valve 104 Central bicarbonate delivery valve 109 Temperature sensor 111 Hydrophobic filter 112 Vent valve 114 Dialysate filter 115 Sensor disinfection valve 116 Sampling valve 117 Check valve (concentrate) 118 Check valve (bicarbonate) 119 Filter (concentrate) 120 Filter (bicarbonate) 121 Central concentrate delivery connector 122 Central bicarbonate delivery connector 123 Pressure switch for V102 124 Pressure switch for V104 125 Temperature compensation plate 130 bibag ® drain valve 131 bibag ® block 131a bibag ® air sep. chamber 131b bibag ® mixing chamber 132 bibag ® conductivity measuring cell 133 bibag ® temperature sensor 134 bibag ® pressure transducer 135 bibag ® level sensor 136 bibag ® connector 137 bibag ® microswitch 1 138 bibag ® microswitch 2 148 Filter/rinse valve 100 149 Filter/rinse valve 99 150 Filter 151 Orifice 181 Temperature compensation plate 2 182 Pressure transducer 2 183 Test valve 184 Test valve filter 185 Compressor 188 Evacuation valve 189 Retentate valve 201 Air separator 202 Level sensor 203 Air separator 204 Level sensor 205 Concentrate / bicarbonate mixing point 206 Buffer volume chamber 210 Filter (degassing orifice) Hydraulics measuring points A Reduced water inlet pressure B Balancing chamber loading pressure C Flow pump pressure D Degassing pump pressure
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1.3.4
Description of the Advanced Hydraulics The hydraulic compartment of the hemodialysis machine consists of a volumetric dialysate balancing system, which is closed against the atmosphere. In the balancing chambers, the used dialysate is displaced by fresh dialysate (and vice versa at the inverse sequence). This assures that equal amounts of dialysate enter and exit the dialyzer. The fresh fluid is separated from the used fluid by an elastic membrane. The float switch (5) provided in the heater block (66) regulates the inflow of fresh water via the water inlet valve (41). The pressure reducing valve (61) ensures a constant water inlet pressure. The fresh water is heated in the heater rod chamber (66b). The degassing pump (29) and the degassing orifice (89) are used to generate a negative pressure, to deaerate the water. The air is collected in the primary air separator (88c). From there, it is directed into the heater rod chamber (66b) via the loading pressure valve (65) and then discharged into the atmosphere via the float chamber (66c). The preheated and deaerated water is delivered from the primary air separator (88c) to the concentrate / bicarbonate mixing point (205). Concentrate containing acetate (or in bicarbonate-based dialysis acid concentrate) flows from the concentrate suction tube (94) through the concentrate air separator (201) and the concentrate pump (23) to the concentrate/bicarbonate mixing point (205). In bicarbonate-based dialysis, bicarbonate is transported via the bicarbonate suction tube (95), the air separator (203) and the bicarbonate pump (25) to the concentrate / bicarbonate mixing point (205). The evacuation valve (188) and the bibag® drain valve (130) are provided for deaeration. The conductivity measuring cell (132) und the temperature sensor (133) measure and monitor the bicarbonate conductivity. At the concentrate/bicarbonate mixing point (205) the appropriate concentrates are mixed with water. The dialysate then flows across the balancing chamber (68), the dialysate filter (114) and the conductivity cell (7) to the dialyzer. The dialysate filter (114) holds back pyrogenic substances and microorganisms. In the conductivity cell (7), both the conductivity and the temperature (temperature sensor 3) are measured and indicated on the monitor. The temperature sensor (109) controls the temperature. If temperature and conductivity are within the alarm limits, the two dialyzer valves (24 and 24b) are open and the bypass valve (26) is closed. Should one of the two values be outside the alarm limits (temperature or CD alarm), the bypass valve (26) opens and the dialyzer valve (24) closes. The integrity of the DIASAFE®plus (114) membrane is checked by ventilating the internal capillary space via the vent valve. The retentate valve (189) is used to rinse retentate from the internal capillary space of the DIASAFE®plus (114).
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The used dialysate coming from the dialyzer is monitored by a blood leak detector (8). From there, it flows into the secondary air separator (88b) of the multifunction block (88). The fluid coming from this chamber is forced by the flow pump (21) into the balancing chamber (68). Thus, it is ensured that the outflowing dialysate is always replaced by the same volume of fresh dialysate. The pressure transducer (9) is provided in the secondary air separator (88b) of the multifunction block (88). The pressure measured there is used as a quantity in the computation of the TMP. A membrane pump (UF pump 22) with a volume of 1 ml per stroke withdraws fluid from the system at a specified rate. Since the system is closed, the same volume is removed as ultrafilatrate from the blood across the dialyzer. After the balancing chamber (68), the used dialysate is directed to the drain via the valve (30), the heat exchanger (77) and the drain valve (87). Part of the heat of the dialysate flowing to the drain is dissipated by the heat exchanger (77) into the cold, inflowing water. Any penetration of a larger volume of air into the system, caused by strong degassing or during priming, is detected by the level sensor (6). This air is discharged into the atmosphere via the air separation pump (97). The sampling valve (116) is located in the dialyzer inflow line. Here, dialysate can be withdrawn using a Luer-lock syringe. The pressure measurement points A, B, C, and D allow direct measurement of various pressures, without having to separate lines and tubings. Measurement point A measures the water inlet pressure; B the balancing chamber loading pressure, C the flow pump pressure, and D the negative pressure created by the deaeration pump. In the hot rinse and disinfection programs, the machine is operated in the recirculation mode. Here the drain valve (87) is closed and the recirculation valve (86) opens. The recirculation mode saves energy (hot rinse) and disinfectant. The circuit is supplied with disinfectant via the disinfectant valve (84) and the sensor (115) of the UF pump (22). The sensor (115) detects presence or absence of disinfectant. When using the CDS option (central concentrate delivery), concentrate containing acetate, or in bicarbonate-based dialysis acid concentrate, flows from the concentrate connector (121) through the valve (102) to the rinse chamber (90a). Bicarbonate is delivered in the same way from the bicarbonate connector (122) through the valve (104) to the rinse chamber (90b). Rinsing the water supply hose (Flush) – option: The water supply hose is rinsed during the test phase (watchdog) each time the dialysis machine is turned on. For this rinse procedure a special valve, V-Flush, (parallel to V41) and a 2nd drain hose are required.
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1.3.5
Central Delivery System (CDS) – optional The desired type of concentrate supply must be selected in the „SETUP menu“ (see Technical Manual). The following 5 options are available: 1. No central delivery system (factory setting) 2. Central bicarbonate supply 3. Central acid supply 4. Central bicarbonate and central acid supply 5. Central acetate supply When selecting a type of central delivery, the user is not restricted to the centrally supplied concentrate. Other concentrates can also be connected by disconnection or connection of the concentrate suction tubes. The valves V102 and V104 are controlled automatically. The hemodialysis machine also recognizes the type of dialysis performed (acetate or bicarbonate dialysis) and uses this information to control the concentrate or the bicarbonate pump respectively.
☞
Note Aspiration of concentrates from the containers has priority (see illustration on the following pages). If, with central delivery, the concentrate suction tube is repeatedly pulled off, the rinse chamber will flow over. The rinse chamber will not be drained before the next cleaning program.
The user has the option to switch off the central delivery system. (See Chapter 2.1.4 Concentrate Supply.)
☞
Note The operator is responsible for the proper installation and function of the CDS.
The following illustrations show the possible combinations of connection for CDS. (The bibag ® option can be used as an alternative to bicarbonate from containers.)
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1. No central concentrate supply
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2. Central bicarbonate supply
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3. Central acid supply
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4. Central bicarbonate and central acid supply
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5. Central acetate supply
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1.4
Description of the Procedure
1.4.1
Description of Bicarbonate Dialysis ● Mode of operation The hemodialysis machine permits the optional performance of acetate or bicarbonate dialysis. The type of treatment is determined by: – the concentrate(s), – the positioning of the concentrate suction tubes. For bicarbonate dialysis two concentrates are required: – acid concentrate, – bicarbonate concentrate (concentrate from containers or bibag® (option)). The concentrates are delivered by two pumps and are mixed with RO (reverse osmosis) water in the hemodialysis machine. The concentrate suction tubes are connected to the appropriate containers. With CDS, the appropriate concentrates are delivered by the central delivery system. The mixing process is volumetric and proportional, i.e. the concentrate pumps add an exact quantity of concentrate to a fixed volume of water. The mixing ratio can be varied. The desired ratio can be selected in the dialysate menu. To change the ratio, the operator must press the Dialysate Menu key. During bicarbonate dialysis, precipitation of calcium and magnesium salts can occur. The machine should therefore be decalcified and disinfected after each bicarbonate dialysis, using a suitable agent (e.g. Puristeril® 340 or Citrosteril®). During a cleaning program, the concentrate suction tubes must be inserted in the rinse ports located on the hemodialysis machine.
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● Concentrates for bicarbonate dialysis The correct ion concentration in the dialysate can only be achieved with concentrates that match the mixing system. Acid concentrate SK-F 203 (PGS 21)/SK-F 003 (PGS 01), 35-fold, 6 l in 10-l container. Bicarbonate concentrate 8.4% sodium hydrogen carbonate solution, 8 l in 10-l container.
☞
Note The contents of opened bicarbonate concentrate containers cannot be stored.
Bicarbonate Concentrate (bibag® – option) Sodium hydrogen carbonate powder, 650 g, 700 g or 950 g bag.
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● Dialysate for bicarbonate dialysis After mixing, the acetic acid from the acid concentrate reacts with the equivalent quantity of bicarbonate, producing carbonic acid and sodium acetate.
With the pumps at standard setting, this produces dialysate, which has the following ion composition: a) SK-F 203 (PGS 21) and 8.4% sodium hydrogen carbonate Sodium 138.00 mval/l 138.00 mmol/l Potassium 2.00 mval/l 2.00 mmol/l Calcium 3.50 mval/l 1.75 mmol/l Magnesium 1.00 mval/l 0.50 mmol/l Chloride 109.50 mval/l 109.50 mmol/l Acetate 3.00 mval/l 3.00 mmol/l Bicarbonate 32.00 mval/l 32.00 mmol/l b) SK-F 003 (PGS 01) and 8.4% sodium hydrogen carbonate Sodium 138.00 mval/l 138.00 mmol/l Potassium 0.00 mval/l 0.00 mmol/l Calcium 3.50 mval/l 1.75 mmol/l Magnesium 1.00 mval/l 0.50 mmol/l Chloride 109.50 mval/l 109.50 mmol/l Acetate 3.00 mval/l 3.00 mmol/l Bicarbonate 32.00 mval/l 32.00 mmol/l
Fig.: Concentrate connectors
Rate: ml/h (Bolus: ml)
(
Rate: ml/h (Bolus: ml)
:h.min)
(
(
Bolus
Bolus
Rate
Rate
Rate
Start Stop
Start Stop
Acetate concentrate
Acetate dialysis
1-38
Rate: ml/h (Bolus: ml)
:h.min)
Bolus
Bicarbonate concentrate
Acid concentrate
Bicarbonate dialysis (bicarbonate from containers)
Fresenius Medical Care 4008 S
:h.min)
Start Stop
11/02.01 (OP)
Acid concentrate
Bicarbonate dialysis (bibag ® option)
● Safety in bicarbonate dialysis Safety of the procedure is ensured by: – two independent volumetric mixing systems, – the temperature-compensated conductivity control, – color-coded suction tubes and containers, – keyed suction tubes and containers. – automatic detection of the connected supply type Procedure The dialysate is continuously prepared from bicarbonate concentrate, acid concentrate, and reverse-osmosis water. Two membrane pumps, which are independent of each other, deliver the acid concentrate solution and the bicarbonate solution in a volumetrically proportional mixing system. Concentrate container coding The container openings are specially keyed to reduce the risk of concentrate errors. The suction tubes are also keyed to prevent them from being attached to the wrong container.
Caution Use only specially keyed containers and mating suction tubes. This system does, however, not exclude the possibility of incorrect use of uncoded containers. Only the dedicated bibag® may be connected to the bibag® connector.
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Fig.: Preparation of the dialysate (schematic) Fig.: for 4008 dialysis machines with basic hydraulics
Degassing pump
to dialyzer via balancing chamber
Concentrate pump
Bicarbonate pump
○ ○ ○ ○ ○ ○ ○
○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
RO water
Concentrate A (acetate or acid)
Concentrate B (Bicarbonate) or (bibag ® Option)
Concentrate container coding
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Fig.: Preparation of the dialysate (schematic) Fig.: for 4008 dialysis machines with advanced hydraulics to dialyzer via balancing chamber
Bicarbonate pump ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
Degassing pump
Concentrate pump
RO water
Concentrate A (acetate or acid)
Concentrate B (Bicarbonate)
or (bibag®) (option)
Concentrate container coding
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● Safety system Measurement of the conductivity and the bypass function prevent that dialysate of the wrong concentration will enter the dialyzer. Monitoring of the rated conductivity to within ±5% by setting alarm limits provides a safeguard against errors in the mixing system. In the event of dialysate of the wrong composition, the conductivity will be outside the alarm limits. The CD alarm, which is then generated, will cause the machine to go into bypass, accompanied by an audible and a visual alarm. An initial error in the mixing system will be detected before the deviation of the dialysate values from the rated value becomes dangerous.
1-42
Error
Maximum deviation
Defect in acid concentrate supply (defective pump, clogged filter) always leads to a reduction in concentration.
CD: Na: Bic: pH:
–0.4 mS/cm –4 mmol/l ±0 mmol/l +0.04
Defect in bicarbonate supply (defective pump, clogged filter) always leads to a reduction in concentration.
CD: Na: Bic: pH
–0.4 mS/cm –6 mmol/l –6 mmol/l –0.19
Defect in water supply or in the balancing chamber: the maximum change in the overall concentration is approximately 0.4 / 13.5 = 0.03 = 3%
CD: Na: Bic: pH:
±0.4 mS/cm ±6 mmol/l ±1 mmol/l ±0.05
Defect in the CD monitor: incorrect indication
No deviation The defect will be detected during the next T1 test.
Defect in the CD monitor: defective alarm evaluation
No deviation The defect will be detected during the next T1 test.
Mistaking bicarbonate concentrate for acid concentrate and vice versa
CD outside alarm limits. (Expected value!) Minimized by keyed containers.
Use of wrong concentrates
CD:
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±0.4
mS/cm
● Mixing ratios
Selectable in Setup
H2O in l
Acid in l
Bic. in l
Mixture Mixture Displayed Concentrate Bicarbonate in menu
1+34 1+35.83 (NaCl 20) 1+35.83 (NaCl 26) 1+35.83 1+44 ACF 1+44 C
32.775 34 34 33.8 42.425 42.225 –
1 1 1 1 1 1 –
1.225 1.83 1.83 2 1.575 1.775 –
35 36.83 36.83 36.83 45 45 –
FREELY PROGRAMMABLE1
28.57 20.13 20.13 18.42 28.57 25.35 –
1+34 1+35.83(A) 1+35.83(C) 1+35.83(B) 1+44 ACF 1+44 C –
B* Belgian bicarbonate 1 for detailed information refer to the Technical Manual
☞
Note For treatment with the bibag ® (option) the mix ratio must be set to 1+34 or 1+44.
● Total conductivity of the ready-to-use dialysate The total conductivity of the ready-to-use dialysate (in mS/cm) is determined by the acidic and basic part of the bicarbonate hemodialysis concentrates. The total conductivity of the ready-to-use dialysate with the appropriate mixing ratio is indicated on each package of the acidic bicarbonate hemodialysis concentrate from Fresenius Medical Care. In the event of a ready-to-use dialysate with 32 mmol/l bicarbonate and 3 mmol/l acid (e.g. acetate content), the contribution of the basic component of the bicarbonate concentrate to the total conductivity is 2.2 mS/cm. The contribution of the acidic component of the bicarbonate concentrate to the conductivity depends on the different electrolytic contents.
● Change in conductivity Based on a basic sodium value of e.g. 140 mmol, the sodium value changes by 5%, if the desired sodium value is increased to 147 mmol. The total conductivity of the ready-to-use dialysate then also increases by 5 %. If the bicarbonate proportion is changed, the acid proportion is changed in the opposite direction, in order to maintain the desired sodium at a constant value. This may result in a minor CD alteration. Example: A rated sodium value of 140 mmol/l corresponds to 105 mmol/l from the acid concentrate and 35 mmol/l from the bicarbonate concentrate. If the bicarbonate is readjusted by + 3 mmol/l (= 38 mmol/l on the bicarbonate pump), the acid concentrate pump is readjusted by –3 mmol/l to 102 mmol/l. The rated sodium value of 102 + 38 = 140 mmol/l is preserved.
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1.4.2
Description of the Variation Function In order to improve the individual tolerance to dialysis treatments, ultrafiltration profiles and sodium profiles can be combined either mutually dependent (e.g. high ultrafiltration with high sodium concentration) or independent. Separate documentation is available from the manufacturer on request.
Fig.: Possibilities of combining UF and sodium profiles
Sodium 1
2
Ultrafiltration
1 2 3 4 5 6
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3
4
5
6
Description of DIASAFE®plus (option) with Basic Hydraulics
1.4.3
● System Components Vent Valve / Hydrophobic Filter The vent valve opens during the pressure holding test to ensure ventilation of the DIASAFE ®plus . A pre-valve hydrophobic filter prevents contamination. Dialysate Filter (DIASAFE®plus) The DIASAFE ®plus is a hollow-fibre filter. Its excellent filtering characteristics can be attributed to the Fresenius Polysulphon ® membrane used.
Fig.: System components
Hydrophobic filter Balancing chamber
Cond./Temp. monitoring
Vent valve
DIASAFE® plus Dialyzer valve 1
Venous bubble catcher Air detector
V24 UF pump
Flow pump
Dialyzer V26
Bypass valve
V24b
Venous line clamp
Dialyzer valve 2
Arterial blood pump
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● Filter Test The filter test (DIASAFE®plus test) is incorporated in the functional test provided it has been preselected by the DIP switch setting on LP 632. When the filter test is started, the internal capillary spaces of the DIASAFE®plus must be ventilated by the vent valve. A special balancing chamber switching cycle is employed to remove fluid from the interal capillary space across the membrane. The hydrophylic membrane rejects air so that a negative pressure builds up in the system. Balancing chamber switching stops at a negative pressure of about – 300 mmHg (peak value). The UF pump increases the negative pressure to about – 450 mmHg. A differential pressure measurement is started. The result computed by the microprocessor must not exceed a pressure change of ± 16.7. The maximum duration of the test is 5 minutes. In the event of a more significant change in pressure, the UF pump will adjust the negative pressure to the initial pressure. Differential measurement is then restarted. Another test criterion is the fluid volume removed. A deviation of ± 30 ml from the expected value of 145 ml will cause the test to stop. An error message will be displayed if the filter fails to pass the test. On successful completion of the functional test the hemodialysis machine switches into bypass mode for a defined period of time. During this period the internal capillary space of the DIASAFE®plus is automatically refilled with fluid.
Fig.: Filter test procedure
Hydrophobic filter Balancing chamber
Cond./Temp. monitoring
Vent valve
DIASAFE® plus Dialyzer valve 1
V24 UF pump
Flow pump
Interlock shunt V26
Bypass valve
V24b
Dialyzer valve 2
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● Dialysis The fresh dialysate flows from the balancing chamber via the conductivity and temperature monitoring system to the DIASAFE ®plus . This filter is integrated in the hydraulic system to ensure that in a no alarm state (no dialysate alarm: V26 closed, V24 and V24b open) the "fresh" dialysate flows across the filter membrane. Ultrapure dialysate enters the dialyzer via valve V24. In bypass mode (dialysate alarm: V26 open, V24 and V24b closed) fluid flows through the inner capillary space of the DIASAFE ®plus . Possible retentate is rinsed from the capillaries and transported to the drain thus overcoming the disadvantages of a dead end filtration.
Fig.: Dialysis procedure Hydrophobic filter Balancing chamber
Cond./Temp. monitoring
Vent valve
DIASAFE® plus Venous bubble catcher
Dialyzer valve 1
Air detector V24 UF pump
Flow pump
Dialyzer V26
Bypass valve
V24b
Venous line clamp
Dialyzer valve 2
Arterial blood pump
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● Cleaning During the cleaning programs the dialysate lines (red/blue) are connected to the interlock shunt. The cleaning agent flows through the balancing chamber to the DIASAFE®plus . Valves V24, V24b and V26 are clocked so that the fluid alternately flows through the internal capillary space (bypass) and across the filter membrane. This ensures that in the bypass mode possible retentate is rinsed from the capillaries and is transported to the drain. The filter is thus thoroughly cleaned, disinfected or rinsed.
Fig.: Cleaning procedure Hydrophobic filter Balancing chamber
Cond./Temp. monitoring
Vent valve
DIASAFE® plus Dialyzer valve 1
V24 UF pump
Flow pump
Interlock shunt
V26
Bypass valve
V24b
Dialyzer valve 2
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1.4.4
Description of DIASAFE®plus (option) with Advanced Hydraulics ● System components DIASAFE ®plus The DIASAFE ®plus is a hollow-fibre filter. Its excellent filtering characteristics can be attributed to the Fresenius Polysulfon ® membrane. Pressure transducer 2 This transducer is a sensor mounted as a standard component in the hydraulic unit. It is used to control and evaluate the membrane integrity test. Compressor The compressor is required for testing the integrity of the membrane of the DIASAFE®plus. Within a minimum of time it ventilates one side of the filter membrane until the test pressure is achieved. Test valve The test valve is only open as long as the compressor ventilates the filter membranes and the test pressure has built up.
Fig.: System components Balancing chamber (68)
Hydrophobic filter (111) Filter/test valve (184)
Vent valve (112)
Compressor (185) Test valve (183) Air detector Monitor P for venous return pressure
Pressure
Drain valve (87)
DIASAFE® plus (114)
Retentate valve (189) Fill valve (43)
UF pump (22)
Flow pump (21) Pressure transducer (9) P
P transducer 2
Cond./Temp. monitoring (3/7/109)
(182)
Bypass valve (26)
Venous bubble catcher Air detector Dialyzer valve 1 (24)
Dialyzer Venous line clamp
Dialyzer valve 2 (24b)
P
Arterial bubble catcher
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Arterial blood pump
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Arterial pressure monitor
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● DIASAFE ®plus membrane integrity test The integrity of the membrane of the DIASAFE®plus is tested by means of a pressure holding test. This test is integrated in the functional test. For this test, the outer capillaries of the DIASAFE ®plus are ventilated. This is done by the compressor which pumps air via the test valve into the hydraulic system. The inflowing air displaces the fluid in the system via the hydrophilic filter membrane and the retentate valve into the drain. This process continues until the entire outer capillary space is filled with air. As air cannot pass across an intact membrane, a positive pressure will build up on the ventilation side. The pressure transducer 2 controls the compressor and evaluates the integrity test. When the test pressure has been achieved, the compressor is switched off and the test valve closes. The pressure drop per unit of time is used as a measure for the evaluation of the integrity of the membrane.
Fig.: Membrane integrity test procedure (DIASAFE®plus ) Balancing chamber (68)
Hydrophobic filter (111) Filter/test valve (184)
Vent valve (112)
Compressor (185) Test valve (183) Pressure
Drain valve (87)
DIASAFE® plus (114)
Retentate valve (189) Fill valve (43)
UF pump (22)
P transducer 2
Cond./Temp. monitoring (3/7/109)
(182)
Bypass valve (26) Dialyzer valve 1 (24)
Flow pump (21) Pressure transducer (9)
Dialyzer valve 2 (24b)
P
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Interlock shunt
● Dialysis The fresh dialysate flows from the balancing chamber to the DIASAFE®plus. This filter is integrated in the hydraulic system to ensure that in a no alarm state (no dialysate alarm: V26 closed, V24 and V24b open) the "fresh" dialysate flows across the filter membrane. Ultrapure dialysate enters the dialyzer via valve V24. In bypass mode (dialysate alarm: V26 open, V24 and V24b closed) fluid flows through the inner capillary space of the DIASAFE ®plus . Possible retentate is rinsed from the capillaries and transported to the drain thus overcoming the disadvantages of a dead end filtration.
Fig.: Dialysis procedure Balancing chamber (68)
Hydrophobic filter (111) Filter/test valve (184)
Vent valve (112)
Compressor (185) Test valve (183) Air detector Monitor P for venous return pressure
Pressure
Drain valve (87)
DIASAFE® plus (114)
Retentate valve (189) Fill valve (43)
UF pump (22)
Flow pump (21) Pressure transducer (9) P
P transducer 2
Cond./Temp. monitoring (3/7/109)
(182)
Bypass valve (26)
Venous bubble catcher Air detector Dialyzer valve 1 (24)
Dialyzer Venous line clamp
Dialyzer valve 2 (24b)
P
Arterial bubble catcher
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Arterial blood pump
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Arterial pressure monitor
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● Cleaning In all cleaning programs the dialyzer lines (red / blue) must be connected to the interlock shunt. The cleaning agent, water or disinfectant flow via the balancing chamber to the DIASAFE®plus. As the retentate valve, V26 and V24/24b open alternatingly, fluid flows alternatingly through the inner capillary space and the membrane of the filter.
Fig.: Cleaning procedure Balancing chamber (68)
Hydrophobic filter (111) Filter/test valve (184)
Vent valve (112)
Compressor (185) Test valve (183) Pressure
Drain valve (87)
DIASAFE® plus (114)
Retentate valve (189) Fill valve (43)
UF pump (22)
P transducer 2
Cond./Temp. monitoring (3/7/109)
(182)
Bypass valve (26) Dialyzer valve 1 (24)
Flow pump (21) Pressure transducer (9)
Dialyzer valve 2 (24b)
P
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Interlock shunt
1.5
Description of the Extracorporeal Blood Circuit Fig.: Extracorporeal blood circuit – double needle dialysis
Legend 1a 2 3 4 5 6 7a 7b
External hydrophobic filter Arterial pressure monitor Arterial blood pump Heparin pump Arterial bubble catcher Dialyzer External hydrophobic filter Internal hydrophobic filter
8 9 10 11 12 13 14
Vent valve Monitor for venous back pressure Ventilation pump Hydrophobic filter Air detector Venous line clamp Optical detector
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1.5.1
Double Needle Dialysis The arterial blood pump pumps the blood from the patient’s vascular access to the dialyzer. The pressure on the suction side of the pump is measured and monitored by the arterial pressure monitor, which is separated by a hydrophobic filter. Should the pressure exceed or fall below the set limits, a blood alarm is released: the arterial blood pump stops, the venous line clamp is closed, a visual and audible alarm is emitted. Ultrafiltration is stopped. The heparin pump is used to administer heparin doses to the blood at an adjustable rate. After the dialyzer, the blood enters the venous bubble catcher. There, the venous return pressure is measured and monitored within tight limits. The monitor for the venous return pressure is separated by two hydrophobic filters. The venous bubble catcher is located in the air detector as a safeguard against infusion of air. Should the level drop or should there be frothy blood in the venous bubble catcher, a blood alarm is emitted: the arterial blood pump stops, the venous line clamp is closed, a visual and audible alarm is emitted. Ultrafiltration is stopped. After the bubble catcher, the blood passes the optical detector (OD), which differentiates as follows: – OD light (saline or air in the line set) or – OD dark (blood in the line set). From the optical detector, the blood is then returned to the patient (venous needle).
1.5.2
Single Needle Click-Clack Dialysis
☞
Note This procedure should be used in exceptional cases only, since the stroke volumes and, thus, the corresponding recirculation shares can be very unfavorable.
Example for the application of this procedure Should blood flow problems arise in one of the vascular accesses during double needle dialysis, it is still possible to continue the treatment using the installed line set, by selecting SN click-clack. After the switching pressure values have been entered, the venous pressure transducer controls the blood pump and the venous line clamp. Both the arterial and the venous blood line are connected to the remaining vascular access by means of a Y-piece. The venous line clamp is closed, as long as the arterial blood pump is delivering blood. As soon as the upper limit at the venous pressure transducer has been reached in the blood line set, the blood pump stops and the venous line clamp opens. The pressure, which has developed in the line set, returns the stored blood to the patient. As soon as the set lower limit has been reached, the venous line clamp closes, the arterial blood pump starts running, and the same procedure is repeated periodically. Should the cycle time be exceeded by 15 s, an alarm will be emitted. The venous line clamp is closed. The blood pump and the UF pump stop running.
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Fig.: Extracorporeal blood circuit – single needle dialysis (optional)
Legend 1a 2 3 4 5 6 7a 7b 8 9 10
External hydrophobic filter Arterial pressure monitor Arterial blood pump Heparin pump Arterial bubble catcher Dialyzer External hydrophobic filter Internal hydrophobic filter Vent valve Monitor for venous return pressure Ventilation pump
11 Hydrophobic filter 12 Air detector 13 Venous line clamp 14 Optical detector 15a External compliance chamber 15b Internal compliance chamber 16a External hydrophobic filter 16b Internal hydrophobic filter 17 Monitor for SN control pressure 18 SN blood pump
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1.5.3
Single Needle Dialysis (optional) During SN dialysis, blood is alternately collected from and returned to the patient through one needle. This is achieved by means of an additional blood pump module, which includes the single needle control electronics (2-pump procedure with pressure-pressure control). With SN (QSN) in the twin-pump SN system, the mean blood flow is computed as follows: QSN = (BPRart x BPRSN) / (BPRart + BPRSN)
[theoretical value]
The following approximation formula is sufficient for practical use: QSN = (BPRart + BPRSN) / 4 The arterial blood pump pumps blood into the external compliance chamber. The blood volume is dependent upon the set stroke volume (10 to 50 ml). The SN blood pump is not running. The venous line clamp is closed. The external compliance chamber is connected to a pressure transducer in the SN blood pump. The compliance chamber, which is filled with air, is located inside the SN blood pump. As soon as the pressure exceeds the set upper limit, the arterial blood pump stops. The SN blood pump starts and pumps the blood through the dialyzer, the venous bubble catcher and the venous line clamp into the patient. As soon as the pressure in the internal compliance chamber drops below the set lower limit, the described procedure is restarted. The lower changeover point is fixed to 75 mmHg. The upper changeover point depends on the stroke volume entered. Stroke volume (ml) Upper changeover point (mmHg)
10 110
15 130
20 150
25 172
30 195
35 219
40 244
45 270
50 299
The position of the SN blood pump before the dialyzer prevents level fluctuations in the venous bubble catcher and improves stability of the TMP. The therapeutical result (clearance) depends on the effective blood flow and the stroke volume. The higher the stroke volume, the lower the proportionate recirculation. For this reason, the largest possible blood flow and the largest possible stroke volume should be set. These settings differ from patient to patient and, owing to the individual vascular accesses, have different limits. All other components and their functions correspond to those already described for double needle dialysis. The stop detection of both blood pumps is activated. Should one of the pumps stop for longer than the set time (30 seconds), a blood pump stop alarm is emitted.
☞
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Note The design (closed system) of 4008 hemodialysis machines ensures that pressure fluctuations during SN operation will not affect the UF rate or the UF volume.
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1.5.4
Effective Blood Flow and Accumulated Blood Volume The delivery rate display on the blood pump indicates the theoretical blood flow. This value is computed from the rotor speed and the inside diameter of the blood line used. The actual blood flow (effective blood flow) may deviate slightly from this value, because it depends on the different input pressures (arterial pressure) on the pump. The computer of the monitor contains an algorithm which corrects the theoretical blood flow, dependent on the arterial pressure. The value is displayed in the current dialysis menu (Eff. Bld. Flow). Using the actual blood flow and the elapsed treatment time, the monitor computes the accumulated blood volume. This information is displayed in the Cum.bld.vol. field in the Dialysis menu.
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Fig.: Blood pump (SN)
1
Rate: ml/min (Ø: mm)
2 3
11 10
4
Start Stop
9
8
7
6 5
● Description of the blood pump (SN)
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1
Display (indicates the delivery rate, the line diameter, the SN stroke volume, or an error code)
2
Alarm LED (red)
3
Operation LED (green)
4
Pressure connector (Luer-lock connector of the SN pressure measuring line)
5
Clamping piece (holds the installed line segment securely in place)
6
Blood pump cover
7
Rotor (delivers the patient’s blood by means of the rollers and the present line set; the rotor can be removed for cleaning purposes)
8
Sensor (blood pump cover open or closed)
9
Start/Stop key (to turn the blood pump on and off)
10
▼ key (to reduce the delivery rate, the value of the line diameter, or the SN stroke volume)
11
▲ key (to increase the delivery rate, the value of the line diameter, or the SN stroke volume)
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1.6
Initial Start-Up
1.6.1
Relevant Instructions Before Initial Start-Up The following points must be strictly observed to assure safe operation of the hemodialysis machine: ● Electric installation – The national standards and regulations (e.g. in Germany VDE 0107) are to be observed when connecting the machine to the local power supply system. – The use of machines of safety classification I, the quality grade of the protective conductor of the electric installation represents an essential factor. In many countries, pertinent regulations have been specified by national authorities, which must be adhered to. – If the power cord needs to be replaced, use only the original power cord listed in the spare parts catalog. – Connect the equipotential bonding to the rear of the machine, if this is required by the legal regulations of the place of installation (e.g. according to VDE 0107 in rooms of application group 2) or special applications (e.g. according to VDE 0753 relating to intracardiac surgery). Caution When using central venous catheters it is imperative that the potential equillisation be connected. With this special type of application all other applied parts (other medical products) must be of the CF type (isolated applied parts that are approved for use on the heart). Apart from this, applied parts of the CF type (e.g. defibrilators) where the patient currents exceed the maximum allowable CF patient leakage currents may not be used.
– If additional devices, which are not included in the accessories, are connected to the hemodialysis machine, there will be the danger of exceeding the permissible leakage currents. – Do not operate machines or devices, radiating electromagnetic waves (e.g. walkie-talkies, wireless phones, wireless CB transmitting sets), in the vicinity of running hemodialysis machines. The use of this equipment may cause malfunctions in the respective hemodialysis machine. ● Batteries Servicing the built-in batteries: Upon receipt of the hemodialysis machine, the batteries must be charged as follows: – Connect the machine to the external power supply by means of the power cord. – Then turn the machine on for approx. 10 hours. If the machine is not used, this procedure should be repeated every six months.
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● Water supply – Only water, which is suitable for hemodialysis, should be used for operating the hemodialysis machine. The quality of the water should fulfill the AAMI regulations for hemodialysis systems, RD5, 1981, part 3.2. – The ranges of the following parameters are specified in Chapter 1.11 Technical Data: water inlet pressure, supply pressure of the dialysate concentrate, temperature, and flow rates, which are required for operating the hemodialysis machine. – The national rules and regulations with regard to the prevention of reverse flow into the water supply network and the air gap between drain connection and sewage connection must be observed when installing and operating the machine (e.g. in Germany VDE 0753, part 4). For further information refer to Chapter 1.11 Technical Data.
● DIASAFE ®plus (option) water supply When using the DIASAFE®plus attention should be given to the points listed below with regard to the quality of product water, concentrate and dialysate:
Caution Use only reverse osmosis water. Always ensure that both product water and dialysate meet the applicable standard (see below). For microbiologic quality standards / recommendations refer to the table below.
General notes The microbiologic purity of dialysate prepared in the dialysis center is of critical importance. Product water quality The „European Pharmacopoeia“ (1997) lists maximum limits for chemical and microbiological quality. Modern reverse osmosis units and the appropriate design of water storage and delivery systems (e.g. short distribution loops avoiding stagnant flow zones) enable compliance with this standard. Concentrate quality While acid concentrate may be considered bacteriostatic, bicarbonate concentrate is an ideal nutrient medium for microorganisms. The use of sterile or microorganism-poor concentrates is recommended. On-line dry concentrates (bibag®) aid the preparation of dialysate with high microbiological quality. The use of residues from open canisters and the preparation of bicarbonate concentrate in the dialysis centre are not recommended. Central delivery systems for concentrate or dialysate must meet high hygienic standards and demand regular inspection.
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Dialysate quality The DIASAFE ®plus removes bacteria and endotoxins from dialysate thus enabling the preparation of ultrapure dialysate. Even when using the DIASAFE®plus, it must still be ensured that the microbiological quality standards are complied with. Microbiological quality standards/recommendations Product water
Concentrate
Dialysate (not filtered)
High-purity dialysate
Microbial counts (in CFU/ml)
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