Summary of Contents for Fresenius Medical Care 4008 B
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4008 B Hemodialysis Machine Operating Instructions Software Version 5.3 Edition: 18/10.11 Part no.: M40 165 1 0123 Fresenius Medical Care...
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Operating Instructions 4008 B These Operating Instructions have been updated to 18/10.11 = 18th edition, October 2011 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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4008 B machines without profile function have been marked as such. These Operating Instructions are part of the machine documentation and thus an integral part of the 4008 B hemodialysis machine. They contain information necessary for the use of the 4008 B hemodialysis machine.
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The 4008 B hemodialysis machine reflects the latest state of technology and complies with the require- ments of EN 60601 (IEC 601-1). The 4008 B hemodialysis machine is classified as Class IIb (MDD) equipment. Assembly, installation, adjustment, modification or repair are to be performed only by the manufacturer or persons authorized by him.
Dialysate Alarms ......................4-31 Warnings......................... 4-34 Emergency Operation..................... 4-40 Error Messages During Cleaning Programs ..............4-42 Error Messages After Turning Power On ............... 4-49 Error Messages When Using the Download Function ........... 4-50 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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® plus (option) on Machines with Basic Hydraulics ..... 7-13 ® plus (option) on Machines with Advanced Hydraulics ....Changing the DIASAFE 7-18 ® (option) ........................ 7-29 Transferring Treatment Parameters (Download) ............7-33 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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1-22 ® plus (option) ........1.3.3 Description of the Basic Hydraulics incl. DIASAFE 1-24 Fig.: Flow diagram 4008 B with advanced hydraulics ............ 1-26 1.3.4 Description of the Advanced Hydraulics ................ 1-28 1.3.5 Central Delivery System (CDS) – optional ..............
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1.10.11 Extracorporeal Blood Circuit and Safety Systems ............1-105 1.10.12 Environmental Compatibility and Recycling ..............1-108 1.11 Definition and Terms ....................1-111 1.12 Abbreviations and Symbols ..................1-113 1.12.1 Abbreviations ........................1-113 1.12.2 Symbols .......................... 1-114 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Certificates ........................1-118 1.14.1 EC Certificate ......................... 1-118 1.15 Literature ........................1-122 1.15.1 Hemodialysis in General ....................1-122 1.15.2 Dialysate Filter and ON-LINE HDF ................1-122 1.15.3 Blood Temperature Monitor (BTM) ................. 1-122 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Intended Use 1.1.1 Fields of Application The 4008 B 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.
). The powder is diluted in the machine to obtain ready-to-use bicarbonate. 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). Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Balancing is not affected by these CPHTs, but the effective dialysis time will be reduced by approx. 2 minutes per hour of treatment. Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
4. Remote Control Unit 4008 [including separate Operating Instructions] 5. Water inlet filter (cannot be used in combination with the “Integrated hot rinse” function) 6. ON-LINE-HDF (for dialysis machines without ONLINE plus ™ only) Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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The manufacturer does not assume any responsibility or liability for personal injury or other damage and excludes any warranty for damage to the system resulting from the use of non- approved or unsuitable consumables or accessories. Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
To overcome uneven surfaces (e.g. ele- vator entry): Always push the hemodialysis machine slowly across uneven surfaces to avoid damage or prevent the machine from turning over. 1-10 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
– 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. 1-11 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Rinse chamber Air detector Interlock shunt for dialyzer connecting tubes 2a Modules – Level 2 IV pole (from left to right) Heparin pump ® Rinse chamber, bi b ag connector (option) not used 1-12 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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(filter 1) option Disinfection port 12 DIASAFE Water inlet filter, optional 13 Vent tubing Bicarbonate connector for central delivery 14 Power supply unit system (blue), optional 15 Clamp for dialyzer connecting tubes 1-13 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Variation Prog. Dialysis Start Reset Alarm Tempera- Flow ture Alarm Tone Prog. Mute 17c 18b Fig.: Hemodialysis machine – monitor front (4008 B without profiles) Fresenius Medical Care 4008 B 20c 20d Confirm Select Arterial Venous Transmembrane Air Detector Ultrafiltration...
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Disinfection key UF LED Disinfection LED UF I/O key Single Needle key UF Prog. key (not applicable for 4008 B without profiles) Single Needle LED Test key Test LED Dialysate monitor (pos. 16 – 18) Prime key Conductivity alarm indicator...
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Fig.: Hemodialysis machine – monitor rear and power supply unit 1-16 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Power cable with locking screw (supplies the hemodialysis machine with line voltage) Loudspeaker for audible alarm Port for connection of the 4008 Remote Control (optional) Key interface (patient identification in conjunction with FINESSE) (optional) 1-17 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Sensor (blood pump cover open or closed) Start/Stop key (to turn the blood pump on and off) key (to reduce the delivery rate or the line diameter) key (to increase the delivery rate or the line diameter) 1-18 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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(to increase the delivery rate or to increment the stop-watch time, and to move the slide carriage up) Power indicator (green) Display (displays the delivery rate, the stop-watch time, the bolus amount or an error code) Alarm indicator (red) 1-19 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Keys (to raise ( ) and lower ( ) the fluid level in the venous bubble catcher) Venous pressure connector (Luer-lock connector of the venous pressure measuring line) Holder for the venous bubble catcher with ultrasonic sensors Venous line clamp Optical detector 1-20 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Next page: Fig.: Flow diagram of basic hydraulics incl. DIASAFE ® plus plus plus (option) plus plus 1-21 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Fig.: Flow diagram of basic hydraulics incl. DIASAFE ® plus (option) 1-22 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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151 Orifice 85 Disinfectant connector 210 Filter (degassing orifice) 86 Recirculation valve Hydraulics measuring points A Reduced water inlet pressure B Balancing chamber loading pressure C Flow pump pressure D Degassing pump pressure 1-23 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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). 1-24 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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The water supply hose, which comes with the machine, is rinsed up to the water inlet valve (41) during the test phase (initialization) 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. 1-25 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Fig.: Flow diagram 4008 B with advanced hydraulics 1-26 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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88c Primary air separator A Reduced water inlet pressure 89 Degassing orifice B Balancing chamber loading pressure valve 90a Rinse chamber concentrate C Flow pump pressure 90b Rinse chamber bicarbonate D Degassing pump pressure 1-27 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
(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). 1-28 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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The water supply hose, which comes with the machine, is rinsed up to the water inlet valve (41) during the test phase (initialization) 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. 1-29 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
The operator is responsible for correct installation and function of the CDS. The following illustrations show the possible combinations of connection with regard to the CDS. (The bi b ag ® option can be used as an alternative to bicarbonate from containers.) 1-30 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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1. No central concentrate supply 1-31 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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2. Central bicarbonate supply 1-32 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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3. Central acid supply 1-33 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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4. Central bicarbonate and acid supply 1-34 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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5. Central acetate supply 1-35 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
(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. 1-36 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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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 (bi b ag – option) Sodium hydrogen carbonate powder, 650 g, 700 g or 950 g bag. 1-37 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Bolus Rate Rate Rate Start Start Start Stop Stop Stop Acetate Bicarbonate Acid Acid concentrate concentrate concentrate concentrate Acetate dialysis Bicarbonate dialysis Bicarbonate dialysis (bi b ag ® (bicarbonate from option) containers) 1-38 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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This system does, however, not exclude the possibility of incorrect use of uncoded containers. ® ® Only the dedicated bi b ag may be connected to the bi b ag connector (option). 1-39 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
4008 dialysis machines with basic hydraulics to dialyzer Degassing via balancing chamber pump Concentrate Bicarbonate pump pump Concentrate A Concentrate B (acetate or acid) (Bicarbonate) or (bi b ag ® Option) water Concentrate container coding 1-40 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
4008 dialysis machines with advanced hydraulics to dialyzer via balancing chamber Concentrate Bicarbonate pump pump Degassing pump ® Concentrate A Concentrate B or (bi b ag (acetate or acid) (Bicarbonate) (Option) water Concentrate container coding 1-41 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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The defect will be detected during the next T1 test. Mistaking bicarbonate concentrate for CD outside alarm limits. acid concentrate and vice versa (Expected value!) Minimized by keyed containers. Use of wrong concentrates ±0.4 mS/cm 1-42 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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2.2 mS/cm. The contribution of the acidic component of the bicarbonate concentrate to the conductivity depends on the different electrolytic contents. 1-43 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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(= 38 mmol/l on the bicarbonate pump), the acid concentrate pump is readjusted by –3 mmol/l to 102 mmol/l. The prescribed sodium value of 102 + 38 = 140 mmol/l is preserved. 1-44 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
1.4.2 Description of the Variation Function (not applicable for 4008 B without profiles) In order to improve the individual tolerance towards dialysis treatments, ultrafiltration profiles and sodium profiles can be combined, either depending upon each other (e.g. high ultrafiltration with high sodium concentration) or independently of each other.
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. 1-55 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
16a External hydrophobic filter 7b Internal hydrophobic filter 16b Internal hydrophobic filter 8 Vent valve 17 Monitor for SN control pressure 9 Monitor for venous back pressure 18 SN blood pump 10 Ventilation pump 1-56 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
(factory setting: 30 seconds), a blood pump stop alarm is emitted. Note The design (closed system) of 4008 hemodialysis machines ensures that pres- sure fluctuations during SN operation will not affect the UF rate or the UF volume. 1-57 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
(See Chapter 7.4.1 Displaying the Effective Blood Flow.) Using the actual blood flow and the elapsed treatment time, the monitor computes the accumu- lated blood volume. This information can also be displayed under menu option 4. 1-58 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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(to reduce the delivery rate, the value of the line diameter, or the SN stroke volume) key (to increase the delivery rate, the value of the line diameter, or the SN stroke volume) 1-59 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
(e.g. according to DIN VDE 0100-710 in rooms of application group 2). Caution The use of additional extension cables or multiway sockets / connectors is prohibited. 1-60 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Additionally, the room must comprise a potential equalization. For further information refer to the national regulations. 1-61 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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– 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. 1-62 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Always ensure that both product water and dialysate meet the applicable standard (see below). For microbiologic quality standards / recommendations refer to the following table. General notes The microbiologic purity of dialysate prepared in the dialysis center is of critical importance. 1-63 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Microbiological quality standards/recommendations Product Concentrate Dialysate High-purity water (not filtered) dialysate Microbial <100 <1000 <1000 <1 counts (in CFU/ml) Endotoxins <0.25 <1 <1 <0.03 (in IU/ml) CFU: Colony-Forming Units International Units 1-64 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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The machine may only be used as specified in the machine documentation. Only under these conditions will the manufacturer consider himself responsible for any effects on the safety, the reliability, and the performance of the machine. 1-65 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
1.6.2 How to Connect the Hemodialysis Machine Initial start-up of the machine should be performed by the Fresenius Medical Care technical customer service or a person authorized by them. – When bringing the hemodialyis machine from a cooler into a warmer room, allow approx. 2 hours for the machine to adjust to the ambient temperature before turning the unit on.
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On completion of the mandatory rinse set the service switch back to OFF (down) again. Press the Rinse key. Rinse mmHg The Rinse LED is illuminated. Hotrinse Blood Leak Disinfection Single –10 Needle –100 1-67 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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The Rinse LED stops lighting. If no DIASAFE ® plus (option) is used, the user can now perform the technical safe- ty checks (TSC). (See Chapter 1.13 Technical Safety Checks.) 1-68 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
– The optical detector senses clear fluid. – Both dialyzer lines are in the interlock shunt. – The shunt door is closed. – The concentrate suction tubes must be locked in the rinse chamber. 1-69 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Fresenius Medical Care 4008 B Turn the hemodialysis machine off! The I/O LED stops lighting. Arterieller Luftdetektor Druck Open the locking levers. Slide the protective caps upwards and out of the guide slot. 1-70 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Remove the protective straps from the new filter by pulling the lug. Slide the new filter from the top into the guide slot. Close the locking levers. 1-71 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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The Test LED is flashing. Test –300 –40 If the Test LED is not flashing, one of the conditions for the test to start is not Prime fulfilled. Dialysis Start Reset Alarm Alarm Tone Mute 1-72 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Then run a heat disinfection program or a disinfection program followed by a hot rinse. Caution Disinfect prior to the first treatment. Perform the technical safety checks (TSC). (See Chapter 1.13 Technical Safety Checks.) 1-73 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
– The optical detector senses clear fluid. – Both dialyzer lines are in the interlock shunt. – The shunt door is closed – The concentrate suction tubes must be locked in the rinse chamber. 1-74 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Use the key to select Confirm Select 5.5 Filter change 5.5 Filter change. Press the Confirm key. Display message in the status line while Confirm Select Empty filter the filter is being emptied. 1-75 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Select Confirm Filter changed ? Open the locking levers. Slide the protective caps up and out of the guide slot. Remove the protective straps from the new filter by pulling the lug. 1-76 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Slide the new filter from the top into the guide slot. Close the locking levers. Press the Confirm key to confirm the fil- Confirm Select Filter changed ? ter change. 1-77 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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SETUP will be started automatically. Caution The machine must be disinfected prior to initating the first treatment. Perform the technical safety checks (TSC). (See Chapter 1.13 Technical Safety Checks.) 1-78 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
– 24 V and 12 V supply voltages – Software watchdog – Shunt door – Dialyzer lines connected – Concentrate and bicarbonate suction tubes connected – CDS – V84 – Retentate valve 1-79 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
), the previously used disinfectant must be thorougly rinsed from the suction tube. When the disinfectant is to be drawn in from the front (PGM 5), ensure that a container with a sufficient amount of disinfectant is connected. Avoid aspiration of air. 1-80 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Time: adjustable from Time: adjustable from 15 to 30 min in the 15 to 30 min in the SETUP menu SETUP menu Timing: Timing: from > 80 °C from > 80 °C 1-81 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
The dialyzers, blood lines and syringes listed in this chapter are disposables, identified by the symbol: = do not re-use. The 4008 B hemodialysis system has been approved for use with the disposables listed below within the scope of the EC design certification. Dialyzers ®...
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Optional to the 20-ml heparin pump The heparin syringe used must have been approved for use within the scope of the design approval for the machine. For further information contact the sales representative. 1-83 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
800 ml/min approx. 4 hours approx. 6 hours Saline solution Isotonic saline solution available in various bag sizes: – Fresenius PVC bag with plug – Fresenius Freka-Flex bag – Fresenius Duoflex bag 1-84 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
In case of treatments with High-Flux membranes, we additionally recommend to ® perform a regular alkaline cleaning with Sporotal 100. ® Puristeril plus must not be used on machines with the DIASAFE (old) and ON- LINE-HDF options. 1-85 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Active substance base: citric acid hydrate Active substance concentration: approx. 0.8% (diluted) Fresenius Diasteril ® (Water temperature in the cleaning program: 84 °C) Active substance base: hydroxyacetic acid Active substance concentration: approx. 0.8% (diluted) 1-86 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Active substance base: citric acid hydrate Active substance concentration: approx. 0.8% (diluted) ® Fresenius Diasteril (Water temperature in the cleaning program: 37 °C) Active substance base: hydroxyacetic acid Active substance concentration: approx. 0.8% (diluted) 1-87 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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DIASAFE plus plus plus Fresenius ClearSurf™: Type of disinfection: scouring/wiping disinfection Active substance base: cationic tensides Use concentration: see product description 0.5 % – 1 hour 1.0 % – 15 minutes 1-88 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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1.9.3 DIASAFE ® plus plus plus plus plus (option) Caution ® plus specified herein. Use only the original DIASAFE Observe the “use by” date printed on the packaging. “Use by” symbol: 1-89 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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604 804 1 22 mm Steam Venous – FV 234 B S 604 834 1 30 mm Steam AV-SN-Set FMC (FA 514 SN B / FV 204B) G 501 703 1 22 mm Gamma 1-90 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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603 062 1 Controlled volume pump 20 ml 603 063 1 DIASAFE ® plus plus plus plus plus (option) ® plus ) Dialysate filter (DIASAFE 500 820 1 12 filters per box 1-91 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Electrical Safety (classifications according to EN 60601-1, IEC 601-1) Type of protection Safety classification I against electrical shock: Degree of protection Type B Symbol: against electrical shock: Protection against Drip-proof Symbol: IPX1 ingress of liquids: Leakage currents: According to TSCs 1-92 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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IEC 61000-4-8 in a typical commercial or hospital environ- ment. Note: U is the a.c. mains voltage prior to application of the test level. 1-93 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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4008 should be observed to verify normal operation. If abnormal performance is observed, addi- tional measures may be necessary, such as reorienting or relocating the hemodialysis machine 4008. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. 1-94 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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(W) according to the transmitter manufacturer. Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 1-95 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Identification of electric and elec- Equipment code (EC) tronic devices Degree of protection against electrical Power requirements shock: type B Protection against ingress of CE mark liquids: drip-proof Type identification, Caution: consult accompanying Serial number documents 1-96 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
–20 °C up to +60 °C (with antifreeze) + 5 °C up to +60 °C (without antifreeze) Stability: 10° IV pole load capacity: Maximum 20 kg Maximum load capacity of one hook: 6 kg 1-97 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Can be used for inhouse computer diagnosis. HDF: Can be used for the connection of an ON-LINE HDF system (optional). ACDA: Currently not used. 4008 Remote control: For connection of a remote control (option) 1-98 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
– a TMP alarm for approx. 2 minutes (time determined by the UF coefficient) When overriding a safety system, the responsibility for the patient’s safety rests with the operator of the machine. 1-99 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Flush, rinsing the water With a water inflow rate of 1.3 l/min and an inlet pressure of 1.5 bar, supply hose (option) the water supply hose will be rinsed with a volume of 260 ml. 1-100 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
V24 and V24b closed; bypass operation holding test: Activation on the outlet side of the dialyzer for 8 seconds every 12.5 minutes. Balancing: Accuracy: ±0.1 % related to the total dialysate volume 1-101 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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10 minutes at the latest. – Bicarbonate: Standard setting 1+27.6; range of readjustment: ±8 mmol/l ® ® – bi b ag (option) Bicarbonate concentrate preparation from the bi b ag Temperature range: 15 to 35 °C 1-102 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Rated value: 450 ml/min – Flow alarm: The dialysate flow is below 180 ml/min. – With water deficiency: Visual alarm, heater turn-off, audible alarm, only if the OD in the LD senses dark 1-103 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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In machines with basic hydraulics the fil- ter service life is not monitored. In machines with advanced hydraulics the filter service is monitored by the dia- lysis machine and indicated by a warning (filter change). 1-104 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Blood pump (SN) Stroke volume: 10 to 50 ml (factory setting: 30 ml) (optional): Resolution: 5 ml Technical data as specified for the arterial blood pump. Pressure transducer for single needle operation: pressure reversal. 1-105 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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An alarm will be initiated when 5 ml of air over a rate of 600 ml/min are detected. The indication of the air volume here refers to microbubbles with a diameter <10 μm when using the tubing systems approved for the machine. Procedure: ultrasonic transmission 1-106 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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For further information contact the sales representative. Audible alarm: – Setting range of the Adjustable with the volume control on the rear of the monitor, minimum setting: ≥ 65 dBA loudness of the audible alarm: 1-107 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
EPDM PPSU PA (PA 6.6) PTFE PBT/ABS GF 20 PC + ABS PVDF Silicone SIK PE (soft) Silicone tubing PEEK VMQ SI (Q) Polyester Silicone TEEE CM/ EPDM-L PP-H Silicone PP(E) EPDM 1-108 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Transformers potting compound PU 151/20, UP resin, iron core Copper + tin, Plug connectors glassfiber enforced thermoplast P.C.B. base material, Electronic scrap ferrite cores, Lithium batteries, lead-acid battery Copper, PVC, Teflon Cables 1-109 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Enamel: Pehapol Base: Epoxy resin Prime coat: P 81.914 (base) Hardener: P 85.033 (PUR) Insulating lacquer: Type FS 190 Dilution: Type FS 225 Screening lacquer Elektro DAG 438/ from Acheson 1-110 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Connector for the pressure measuring line, e.g. Luer-lock. connector Pressure measuring line Line connecting the tubing system to the pressure monitoring unit. Product water Water suitable for hemodialysis (e.g. water purified by reverse osmosis). 1-111 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Pressure in the extracorporeal circuit before the venous cannula (e.g. in the venous bubble catcher). Water alarms Group of alarms which do not cause the blood systems to be turned off: conductivity (bypass operation), temperature (bypass operation), flow. 1-112 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Protective conductor terminal Earth terminal Equipotentiality I / O ON / OFF Start of a specific procedure Dangerous electrical voltage Disconnect power plug before opening Heat dissipation Identification of electric and electronic devices 1-114 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Numbers, which are not listed here, are not included in the TSC, but are part of the maintenance procedures. For further details on technical safety checks and maintenance procedures, refer to the Technical Manual. 1-115 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Substituate pump (part no. 672 521 1) with DC motor: check volume delivered by the pump desired/actual …… / …… Substituate pump (part no. 674 982 1) with stepper motor: check the pump rate – (calibration program:BP-Rate CHECK) 1-116 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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(maximum 500 μA, see also Additional conditions) ………… μA Test equipment used …………………………………………………………… Functional test T1 test performed – Date: Signature: Stamp: The system has been released for further use Remarks: Date: Signature: Stamp: 1-117 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Dr. B. Canaud, Division of Nephrology, Lapeyronie University Hospital, 555, Route de Ganges, 34059 Montpellier, France 1.15.3 Blood Temperature Monitor (BTM) – “Fresenius Publikation” (EDTNA-Journal 1992) with further literature. 1-122 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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2.8.5 Collecting a Fluid Sample ....................2-47 2.8.6 Connecting the Dialyzer ....................2-47 2.8.7 Changing the Dialysate Flow ..................2-49 2.8.8 Changing the Dialysate Temperature ................2-49 2.8.9 Rinsing the Dialyzer ....................... 2-50 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
72 hours Confirm Select 21.12.07 12:30 ago. The machine must be disinfected. Confirm with the Confirm key. The cleaning menu can directly be selected by pressing the Rinse, Hotrinse or Disinfection key. Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
(green) LED light for 1 second. Start Stop Indication of the line diameter for approx. Rate: ml/min (Ø: mm) 2 seconds. Start Stop Indication of the delivery rate. Rate: ml/min (Ø: mm) Start Stop Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Press the keys to select Status CDS. Press the Confirm key. Confirm Select 5.4 Status CDS Press the keys to set the de- sired mode. Press the Confirm key. Select Confirm CDS off Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Start Stop acid container. Place the bicarbonate suction tube (blue) in the bicarbonate container. Bicarbonate Acid concentrate concentrate Caution Assure that the containers contain sufficient concentrate and bicarbo- nate to complete the treatment. Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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The bi b ag ® will be filled when the ® bi b ag and the bicarbonate suction tube have been connected. The bi b ag ® has priority over bicarbo- nate supplied by the CDS. Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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(Bolus: ml) :h.min) Bolus Rate tube for acid and acetate in the acid con- Start Stop tainer. Acid concentrate Press the unlock pad to open the inter- lock plate. Turn the interlock plate 180°. Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Remove the foil from the bi b ag ® Assemble the bi b ag ® onto the interlock plate. Push on both sides of the interlock plate ® to connect the bi b ag 2-10 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Start Stop (lasting approx. 35 seconds). This program will first remove all air from the bi b ag ® and will then fill the bag with water. Acid concentrate 2-11 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
CDS. 2.2.2 Start of the Test Caution If the XX not calibrated message is displayed on starting the functional test, the system must not be used to perform a treatment. 2-12 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
To prevent an automatic start of the test proceed as follows: – Open the shunt door. – Turn the hemodialysis machine – Start the functional test as usual. – Close the shunt door. 2-13 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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The yellow (warning/info) status Care 4008 B indicator is illuminated. Arterial Venous Transmembrane Override –200 –30 Press the Test key. Test –300 –40 The Test LED lights. Prime Dialysis Start Reset Alarm Alarm Tone Mute 2-14 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Temporary display message Confirm Select Prime Confirm Select Prime / Circulation Indication of the test steps Confirm Select Test . . . Display message with parallel test. Confirm Select Test in Progress 2-15 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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UF Volume Override –200 –30 The Test LED is illuminated. Test –300 –40 The Alarm Tone Mute LED is flashing. Prime Audible alarm Dialysis Start Reset Alarm cleared automatically Alarm Tone Mute 2-16 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Temporary display message Circulation The yellow (warning/info) status indicator is illuminated. Arterial Venous Transmembrane Air Detector Ultrafiltrat Pressure Pressure Pressure UF Volume Indication of the test steps Confirm Select Test . . . 2-17 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Press either the Dialysis Start or the Test –300 –40 Prime key. Prime Continue priming by pressing the Prime Dialysis Start Reset Alarm key again, or continue pre-circulation by pressing the Dialysis Start key. Alarm Tone Mute 2-18 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Detector Temperature Blood system neg. Pressure Rinse volume: XXXX ml pos. Pressure Venous UF-Function Air Detector Conductivity Display DIASAFE plus Arterial (optional) Battery Display message during parallel test: Test in progress. 2-19 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
With the tubing system filled Display message Confirm Select Preparation Override –200 The Dialysis Start LED is illuminated. –30 Test –300 –40 Prime Dialysis Start Reset Alarm Alarm Tone Mute 2-20 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
The Test LED is flashing. Test –300 –40 The Alarm Tone Mute LED is flashing. Prime Audible signal Dialysis Start Reset Alarm Alarm Tone Mute Display message Confirm Select T1 Test failed 2-21 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Test key: Skip Battery? Skip Diasafe? Note If the message Skip Battery? is acknowledged by pressing the Test key, a power failure eventually might no longer be signalled by an audible alarm. 2-22 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Press the Test key. Test –300 –40 The Test LED is illuminated. Prime The Alarm Tone Mute LED is dark. Dialysis Start Reset Alarm If the problem persists, call the service. Alarm Tone Mute 2-23 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Press the I/O key Fresenius Medical Care 4008 B Turn the hemodialysis machine off! The I/O LED stops lighting. The test can be prematurely terminated Arterieller Luftdetektor Druck only by turning the machine off. 2-24 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Install the line segment on the right side. Close the blood pump door. Connect the pressure measuring line to the pressure connector. Connect the arterial blood line to the dia- lyzer blood inlet. 2-25 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
(The value is indicated for approx. 2 seconds.) The delivery rate of the blood pump is set to 0. Start Stop Use the key to adjust the delivery rate. Rate: ml/min (Ø: mm) Start Stop 2-26 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
(Bolus: ml) to the heparin line of the arterial line set. :h.min) Insert the syringe. Bolus Press and hold the key until the Rate slide carriage is in the start position. Start Stop 2-27 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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(Bolus: ml) The plate of the syringe plunger must engage in the slide carriage. :h.min) Bolus Rate Start Stop Note Make sure that the syringe wings are in the syringe wing slot. 2-28 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Rate livers at the previous rate. Start Stop Note Administer the heparin dose accord- ing to the physician's instructions. Note For the injection of an initial heparin dose, use the Bolus key. 2-29 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
During this time, the previous delivery time remains active. Rate The stop-watch time indicator (green) Start Stop lights after confirming the selected time. The stop-watch time indicator (green) is illuminated until the selected delivery time has elapsed. 2-30 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Note Place the clot catcher at a level approximately 1 cm below the lower edge of the bubble catcher holder. Caution Do not use ultrasound-conducting media on the air detector. 2-31 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Check the line for proper installation and close the door. Connect the venous pressure meas- uring line to the venous pressure con- nector (Luer-lock). Caution Do not remove the blood line from the optical detector during treatment. 2-32 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
If the pressure measurement unit is contaminated, all affected parts must be disinfected or replaced. Caution When inserting the lines make sure that the blood lines are not kinked. Use the line holders provided. 2-33 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Caution It is important to set the lower ve- nous alarm limit to be as close as possible to the actual value of the ve- nous pressure. 2-34 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Arterial Venous Transmembrane Air Detector Ultrafiltrat illuminated. Pressure Pressure Pressure UF Volume Display message Temporary display message, if a rinse Confirm Select Rinse-volume: XXXX ml volume has been defined in the SETUP. 2-36 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
180 ml/min. The operator may select any delivery rate desired. Use the arrow keys to select the desired delivery rate. (Pressing the keys longer than 3 sec- onds will increase the change rate) 2-37 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Alarm Tone Mute The red (alarm) status indicator is illu- Care 4008 B minated. The Air Detector alarm indicator is flashing. Arterial Venous Transmembrane Air Detector Pressure Pressure Pressure 2-38 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Prime setting selected in the SETUP), proceed as follows: Dialysis Start Reset Alarm Press the Prime key again. Alarm Tone The Prime LED is illuminated. Mute The Dialysis Start LED is dark. 2-39 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Premature Termination Override –200 –30 Press the Dialysis Start key or the Test –300 –40 Prime key. Prime Continue priming by pressing the Prime Dialysis Start key again. Reset Alarm Alarm Tone Mute 2-40 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
2. to check the dialysate for correct physiological composition before initiating dialysis. 3. that the individually adjustable mixing ratio and the bi b ag ® option are not used simultaneously. 2-41 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
® not connected. Use the keys to set the mixing Confirm Select Dilution 1+34 ratio to 1+34. Press the Confirm key to confirm the Select Confirm Dilution 1+XX mixing ratio. 2-42 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Set the prescribed Na value by pressing keys. (Range of adjustment: 125 to 150 mmol) Prescr. Na = base Na ±13 mmol Press the Confirm key. Confirm Select Prescr. Na+ xxx mmol 2-43 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Basic setting: ±0 (or as defined in the Select Confirm Bicarbonate x mmol SETUP setting) Adjust the bicarbonate pump by pressing keys. (Range of adjustment: –8 to +8 mmol) Press the Confirm key. Confirm Select Bicarbonate x mmol 2-44 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Should this not be the case, the ac- tual value must first be checked in the laboratory. If the result turns out to be negative, the machine and/or the concentrates should be checked. 2-45 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Centering the CD window around the actual value Press the Select key. Select Confirm Preparation Press the Confirm key twice. Confirm Select 1. Set cond window 2-46 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Draw up the syringe. Unlock the holder. The key will auto- matically close the valve. 2.8.6 Connecting the Dialyzer Open the shunt door. Confirm Select Shunt Cover open Display message The cone does not move. 2-47 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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(on the side of the arterial feed). Close the shunt door. The conductivity window is set. Observe the external flow indicator: the cone moves up and down. Check and, if necessary, change the dia- lysate flow. 2-48 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Set Temp. xx.x °C temperature. Press the Confirm key. Confirm Select Set Temp. xx.x °C Should the Confirm key not be pressed within 20 seconds, the previous tem- perature value is preserved. 2-49 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
When entering UF parameters and starting UF, only the values entered are relevant. Press the UF I/O key. Time Left h:min Variation Prog. The UF LED is illuminated. Tempera- Flow ture Prog. 2-50 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Stopping the Program ....................3-39 3.6.8 Continuing the Program ....................3-39 3.6.9 Prematurely Terminating the Program ................3-40 ® plus plus plus (option) ....................DIASAFE plus plus 3-41 3.7.1 Display During Treatment ....................3-41 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
0000 Reset Volume Press the UF Reset Volume key, until the UF Volume display indicates 0000. UF Rate ml/h 1000 UF Goal Press the Flow I/O key. 0000 Time Left h:min 0:00 Prog. Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
7. Treatment param.. Press the Confirm key. Press the Confirm key. Confirm Select 7.1 Reset UF data Press the Confirm key. Confirm Select Are you sure ? Temporary display message Confirm Select value(s) cleared ! Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Volume indicated values. UF Rate ml/h 0750 UF Goal 3000 Time Left h:min 4:00 Prog. Ultrafiltration UF Volume 0000 Reset Volume UF Rate ml/h 0000 UF Goal 0000 Time Left h:min 0:00 Prog. Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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UF Volume 0000 Reset Volume Use the keys to enter the de- sired goal. UF Rate ml/h The UF Rate is automatically computed 0750 and indicated. UF Goal 3000 Time Left h:min 4:00 Prog. Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Use the key to set the Time Left to 0. 0000 Reset Volume Use the keys to enter the de- sired rate. UF Rate ml/h 0750 UF Goal 0000 Time Left h:min 0:00 Prog. Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
UF Rate ml/h 0000 UF Goal 0000 Time Left h:min 4:00 Prog. 3.1.4 Starting Ultrafiltration Press the UF I/O key. Time Left h:min Variation Prog. The UF LED is illuminated. Tempera- Flow ture Prog. Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
UF Rate ml/h 0800 UF Goal 4000 Time Left h:min 1:00 Prog. 3.1.6 Continuing Ultrafiltration Press the UF I/O key. Time Left h:min Variation Prog. The UF LED is illuminated. Tempera- Flow ture Prog. Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
UF data. UF Rate ml/h 0750 UF Goal 3000 Time Left h:min 4:00 Prog. Press the UF I/O key. Time Left h:min Variation Prog. The UF LED is illuminated. Tempera- Flow ture Prog. 3-10 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
If infusion of the saline contained in the line is desired, connect now the venous line. Set the delivery rate of the arterial blood Rate: ml/min (Ø: mm) pump to the desired value. Start Stop 3-11 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Dialysis Start The Alarm Tone Mute LED is flashing. Reset Alarm Connect the venous connector of the tu- Alarm Tone bing system to the patient (provided this Mute has not been done yet). 3-12 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Check and, if necessary, correct the level in the venous bubble catcher. ven. 3-13 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
The operation (green) LED is illumin- :h.min) ated. Bolus The heparin pump is delivering. Rate Start Stop Press the UF I/O key. Time Left h:min Variation Prog. The UF LED is illuminated. Tempera- Flow ture Prog. 3-14 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
5 s. (The bolus administration is added to the stored bolus volume.) Then the de- livery rate is indicated. – Maximum bolus administration: 5 ml – Maximum total bolus: 1x syringe capacity 3-15 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Rate: ml/h Rate: ml/min (Bolus: ml) (Ø: mm) heparin pump. Connect the single needle pressure :h.min) transducer. Bolus Start Rate Stop Start Stop Note Do not install the single needle pump line segment! 3-16 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Stop Press the Start/Stop key on the blood Rate: ml/h Rate: ml/min (Bolus: ml) (Ø: mm) pump module. The delivery rate is indicated after :h.min) approx. 2 seconds. Bolus Start Rate Stop 3-17 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Install the single needle pump line seg- Rate: ml/h Rate: ml/min (Bolus: ml) (Ø: mm) ment of the tubing system in the single needle blood pump. :h.min) Bolus Start Rate Stop Start Stop 3-18 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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The Dialysis Start LED is flashing. Dialysis Start Reset Alarm The Alarm Tone Mute LED is flashing. Connect the venous line to the patient Alarm Tone Mute (unless this has already been done). 3-19 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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If single needle dialysis is performed, it is important to dialyze with the maximum blood flow. The effective blood flow can be dis- played in the user menu under option 4. Bloodflow. calc. 3-20 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Press the Confirm key. Use the keys to select Select Confirm 2.3 SN-click-clack 2.3 SN-click-clack. Press the Confirm key. Press the Confirm key. Confirm Select SN-click-clack off ? Display message Select Confirm Dialysis 3-23 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Select 2. Treatment mode 2. Treatment mode. Press the Confirm key. Use the keys to select Confirm Select 2.2 Sequ. Dialysis 2.2 Sequ. Dialysis. Press the Confirm key. Confirm Select ISO-UF value 3-24 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Confirm Select ISO-UF start ? Press the UF I/O key. Ultrafiltration UF Volume The UF LED is illuminated. 0000 Reset Volume UF Rate ml/h UF Goal 5000 Time Left h:min 4:00 Prog. 3-25 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Note After completion of sequential dia- lysis, hemodialysis is automatically continued with dialysate flow and the computed UF parameters. The conductivity alarm and the tem- perature alarm are suppressed for 3 minutes. 3-26 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
2.2 Sequ. dialysis. Press the Confirm key. Press the Confirm key. Confirm Select ISO-UF off ? The dialysate flow is automatically set to “on”. UF data is added. Display message Confirm Select Dialysis 3-27 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Select Confirm 7.3 Reset ISO data 7.3 Reset ISO data. Press the Confirm key. Press the Confirm key. Confirm Select Are you sure ? Temporary display message Select Confirm value(s) cleared ! 3-28 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Variation The dialysate monitor is dark. Prog. Display message Tempera- Flow ture Prog. Audible signal after 30 minutes. (Adjustable in the SETUP menu: Confirm Select Flow off 30, 45, 60 minutes.) 3-29 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Conc The dialysate monitor is active again. mmHg Temperature and conductivity are 15.5 UF Rate ml/h stabilizing. 14.5 UF Goal 13.5 mS/cm (25°C) Time Left h:min Variation Prog. Tempera- Flow ture Prog. 3-30 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Sodium and UF Profiles ( not applicable for 4008 B without profiles ) 3.6.1 General Notes Before selecting profiles, the following values should have been entered: – Base Na+, prescr. Na and bic. – UF Goal (minimum UF goal: 200 ml) –...
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When selecting a profile, the machine will prompt the operator to enter missing or to correct incorrect data. Profile data comprise UF and Na profile types as well as start Na For possible profile combinations refer to the illustration on possible sodium and UF profile combinations. 3-32 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
If no sodium profile is desired: Confirm Select Na Profile Nr. X Use the keys to select Na Profile Off. Press the Confirm key. Confirm Select Na Profile Off Temporary display message Confirm Select Profiles ready 3-33 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Start Na+ Start Na+ Soll Na+ Prescribed Na+ Base Na+ Basis Na+ (container value) (Kanisterwert) Press the Confirm key. Confirm Select Start Na+ 143 mmol Temporary display message Confirm Select Profiles ready 3-34 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
If no UF profile is desired: Confirm Select UF Profile Nr. X Use the keys to select UF Profile Off. Press the Confirm key. Select Confirm UF Profile Off Temporary display message Confirm Select Profiles ready 3-35 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Missing initial parameters are in- quired when entering a profile. Profile, UF and dilution parameters cannot be reprogrammed while the program is in progress. The profile must be stopped and re- started with the changed parameters. 3-36 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Press the Confirm key. Confirm Select Na Profile Nr. X Press the Confirm key. Select Confirm Start-Na xxx mmol/l Press the Confirm key. Confirm Select UF-Profile Nr. X Display message Confirm Select Dialysis Na-X UF-X 3-37 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Press the Dialysis Start key. Test –300 –40 Prime The Dialysis Start LED is illuminated. Dialysis Start The Alarm Tone Mute LED is dark. Reset Alarm Alarm Tone Mute Display message Confirm Select Reinfusion ? 3-38 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Stop UF-Profile ? in case of UF and Na profiles or UF pro- file only or in case of Na profile. Select Confirm Stop Na-Profile ? (brief indication) The stopped program is automatically continued. 3-39 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
The Variation LED is illuminated. The Na profile is active. Stop the Na profile. Repeat the procedure. Display message, e.g. Confirm Select Dialysis Na-X UF-0 0 indicates that the program was stopped. 3-40 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
DIASAFE plus plus 3.7.1 Display During Treatment Temporary display message Select Confirm Rinsing Diasafe Retentate removed by rinsing (approx. every 60 minutes for 5 balancing cham- ber switching cycles) Machine in bypass 3-41 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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3-42 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Error Messages During Cleaning Programs .............. 4-42 4.7.1 Indication of Errors ......................4-42 4.7.2 Error Messages ......................4-43 Error Messages After Turning Power On ..............4-45 Error Messages When Using the Download Function ..........4-50 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
–10 –100 –20 Override –200 –30 –300 –40 Override –200 –30 Press the Dialysis Start key. Test –300 –40 Prime Dialysis Start Reset Alarm Alarm Tone Mute Display message Confirm Select Center limit? Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Both the arterial and the venous alarm Arterial Venous Transmembrane windows are centered around the actual Air Detector Pressure Pressure Pressure value. mmHg mmHg mmHg Blood Leak –10 –100 –20 Override –200 –30 –300 –40 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Pressure (Time-dependent upon the UF coefficient.) mmHg mmHg mmHg The position of the TMP alarm window may automatically be shifted up during Blood Leak treatment. –10 –100 –20 Override –200 –30 –300 –40 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Select Confirm Set TMP Limits sition of the TMP window. Arterial Venous Transmembrane Air Detector Pressure Pressure Pressure mmHg mmHg mmHg Blood Leak –10 –100 –20 Override –200 –30 –300 –40 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Use the keys to change the Confirm Select Set TMP Limits size of the TMP window. Double needle: ±30 to ±80 mmHg Single needle: ±40 to ±90 mmHg SN click-clack: ±40 to ±90 mmHg Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Confirm Select 3.3 TMP limits 3.3 TMP limits . Press the Confirm key. Use the keys to select Select Confirm TMP window size TMP window size. Press the Confirm key twice. 4-10 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Press the Confirm key. Use the keys to select Confirm Select 2.5 Needle-Adj–Pgm 2.5 Needle-Adj-Pgm. Press the Confirm key. Press the Confirm key. Confirm Select Stop Needle-Adj–Pgm? Display message Confirm Select Dialysis 4-12 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
The UF pump(s) stop(s). Blood Leak Disinfection The nurse call is active. Audible signal Single –10 Needle –100 –20 Override –200 –30 Test –300 –40 Prime Dialysis Start Reset Alarm Alarm Tone Mute 4-13 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
If the key is not pressed within approx. Prime 8 seconds, the original limits will be re- tained. Dialysis Start Reset Alarm The Dialysis Start LED is illuminated. Alarm Tone Mute The Alarm Tone Mute LED is illumin- ated. 4-14 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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–300 –40 The arterial limits are centering around Arterial Venous Transmembrane the acutal value. Air Detector Pressure Pressure Pressure mmHg mmHg mmHg Blood Leak –10 –100 –20 Override –200 –30 –300 –40 4-15 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
If the key is not pressed within approx. Prime 8 seconds, the original limits will be re- tained. Dialysis Start Reset Alarm The Dialysis Start LED is illuminated. Alarm Tone Mute The Alarm Tone Mute LED is illumin- ated. 4-16 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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–300 –40 The venous limits are centering around Arterial Venous Transmembrane the actual value. Air Detector Pressure Pressure Pressure mmHg mmHg mmHg Blood Leak –10 –100 –20 Override –200 –30 –300 –40 4-17 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
If the key is not pressed within approx. Prime 8 seconds, the original limits will be re- tained. Dialysis Start Reset Alarm The Dialysis Start LED is illuminated. Alarm Tone Mute The Alarm Tone Mute LED is illumin- ated. 4-18 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Venous Transmembrane around the actual value. Air Detector Pressure Pressure Pressure mmHg mmHg mmHg Blood Leak –10 –100 –20 Override –200 –30 –300 –40 Caution Sudden TMP changes are indicative of defect. 4-19 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
See also Chapter 4.5 Warnings, Message Fillprogram Prime Dialysis Start Reset Alarm Alarm Tone Mute In the event of grease and/or calcium precipitate: Run the usual disinfection program on completion of the treatment. 4-20 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Override time: always 2 minutes As soon as the leak closes, the alarm in- Single –10 Needle dicator turns dark. –100 –20 Override If the problem persists, replace the dia- –200 –30 lyzer. Test –300 –40 4-21 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Press the Start/Stop key. E.XX Start Stop Override –200 –30 Press the Dialysis Start key. Test –300 –40 Prime Dialysis Start Reset Alarm Alarm Tone Mute Note If the problem persists, call the service. 4-22 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Bolus Rate Start Stop Override –200 –30 Press the Dialysis Start key. Test –300 –40 Prime Dialysis Start Reset Alarm Alarm Tone Mute Note If the problem persists, call the service. 4-23 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
180 ml/min. Override –200 –30 Press the Dialysis Start key. Test –300 –40 Prime Dialysis Start Reset Alarm Alarm Tone Mute 4-24 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Cause: The rotor has stopped for more than 30 (15) seconds. Start Stop Override –200 –30 Press the Dialysis Start key. Test –300 –40 Prime Dialysis Start Reset Alarm Alarm Tone Mute 4-25 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Remove the SN pump line segment. Rate: ml/h Rate: ml/min (Bolus: ml) (Ø: mm) Disconnect the SN pressure measur- ing line and connect it to a syringe. :h.min) Bolus Start Rate Stop Start Stop 4-26 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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:h.min) Bolus Start Rate Stop Start Stop Stop the arterial blood pump by pressing Rate: ml/min (Ø: mm) the Start/Stop key. The operation LED is dark. Start Stop 4-27 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Stop Connect the SN pressure measuring Rate: ml/h Rate: ml/min (Bolus: ml) (Ø: mm) line and remove the clamp. Install the SN pump line segment. :h.min) Bolus Start Rate Stop Start Stop 4-28 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Override –200 –30 Press the Dialysis Start key. Test –300 –40 The Dialysis Start LED is illuminated. Prime The Alarm Tone Mute LED is dark. Dialysis Start Reset Alarm Alarm Tone Mute 4-29 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Override –200 –30 Press the Dialysis Start key. Test –300 –40 The Dialysis Start LED is illuminated. Prime The Alarm Tone Mute LED is dark. Dialysis Start Reset Alarm Alarm Tone Mute 4-30 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
UF Rate ml/h the alarm limits. Action required: 14.5 Check the concentrate side. UF Goal Correct the problem causing the alarm. 13.5 mS/cm (25°C) Time Left h:min Variation Prog. Tempera- Flow ture Prog. 4-31 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Upper temp. alarm Bypass mode Cause: The actual temperature value is outside Confirm Select Lower temp. alarm the permissible values. Action required: Wait until the target temperature has been reached, or call the service. 4-32 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
The operator can decide if the treat- ment should be continued with the reduced flow. Display message Confirm Select Water alarm Cause: Water supply problem. Action required: Check the water supply. Call the service. 4-33 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Disinfection The blood system and the dialysate sys- Single tem are inactive. –10 Needle –100 –20 Audible signal Override –200 –30 Test –300 –40 Prime Dialysis Start Reset Alarm Alarm Tone Mute 4-34 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
UF off. into consideration. If the test fails to be passed repeatedly, discontinue the treatment and call the service. Failure to do so may lead to a bal- ancing error. 4-35 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Dialysis Start key. If the message dis- plays repeatedly, discontinue the treatment and call the service. Failure to do so may lead to a balancing error (incorrect UF volume). 4-36 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Heparin Pump Alarm.) Heparin pump not on The heparin pump Press the Dialysis Approx. – module is not Start key (no 11 min switched on. heparinization), or switch on the heparin pump. 4-37 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Press the Dialysis 2 min 30 min the delivery rate of Start key. Reduce the blood pump, the the ultrafiltration ultrafiltration rate is rate, or increase the too high. blood pump rate. 4-38 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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(+5 V, +12 V, +24 V). off and on again. Call the service. Wrong conc. supply Wrong concentrate Check the concen- – – composition. trate side. 4-39 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
The extracorporal blood circuit is main- tained. Override –200 –30 The Dialysis Start LED is illuminated. Test –300 –40 The Alarm Tone Mute LED is flashing. Prime Dialysis Start Reset Alarm Alarm Tone Mute 4-40 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Visually check the line for air (emergency operation)! In Single Needle mode, also remove the BP segment for the BP (SN) from the blood pump! 4-41 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
–10 Needle –100 The Alarm Tone Mute LED is flashing. –20 Override –200 –30 The dialysate system is inactive. Test –300 –40 Audible signal Prime Dialysis Start Reset Alarm Alarm Tone Mute 4-42 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Start a disinfection program. (202) shorted. Call the service. Conc line not conn The concentrate connector is Insert the concentrate connec- not inserted in the rinse cham- tor in the rinse chamber. ber. 4-43 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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® plus .) ments reached (after 100 If the filter is not changed, treatments). treatment cannot be initiated. Maximum filter service life ex- ceeded. Maximum number of disinfec- tions with Sporotal reached. 4-44 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Optical detector test failed. Problem cannot be corrected (only while priming/ in the cleaning program precirculation is in (precirculation impossible). progress during the After cleaning: perform a func- cleaning programs) tional test. Call the service. 4-45 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Pressure loss on PSW 123. Call the service. * This error message may be indicated alternately with the message DO NOT SWITCH OFF !! Turn the machine off after 1 min only! 4-46 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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(only with priming/ cleaning mode. (If cleaning can be started al- precirculation is in though the two dialyzer coup- progress during the lings are not in the interlock cleaning programs) shunt: Call the service.) 4-47 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Call the service. Water alarm Float switch for t>30 s high. Check the water supply. Float switch for t>10 s low. Cleared automatically. Call the service. 4-48 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Call the service. Watchdog Error This error message will only Use the I/O key to turn the be displayed immediately machine off and on. after turning power on. Call the service. 4-49 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
(UF profile/Na profile). Restart data transfer. Download Error F011 Illegal UF or Na profile number. Check external data. Restart data transfer. Download Error F012 Unacceptable dialysate flow. Check external data. Restart data transfer. 4-50 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Check external data. Restart data transfer. Download Error F022 profile data plausibility. Check external data. Restart data transfer. Download Error F023 Invalid CRC of the patient key. Check patient key. Restart data transfer. 4-51 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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4-52 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Stopping the Treatment ....................5-10 5.3.1 Without Reinfusion ......................5-10 5.3.2 Stopping the Treatment With Reinfusion Program ............5-13 Emptying the bi b ag ® (option) ..................5-17 Emptying the Dialyzer ....................5-19 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Press the Dialysis Start key. Test –300 –40 The Dialysis Start LED is illuminated. Prime If necessary, switch the heparin pump Dialysis Start Reset Alarm off. Alarm Tone Mute Display message Select Confirm Reinfusion ? Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
(Ø: mm) side. :h.min) Press the Start/Stop key, until the Bolus tubing system has been completely Start Rate Stop removed. Start Stop Remove the line segment on the right side. Close the cover. Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Press the Single Needle key. Rinse mmHg The Single Needle LED turns dark. Hotrinse Blood Leak Disinfection Single Needle –10 –100 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Disconnect the arterial patient connector and connect the line to the return solu- tion. Break the cone. Use the key to reduce the delivery Rate: ml/min (Ø: mm) rate of the blood pump. Start Stop Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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The Dialysis Start LED is illuminated. Prime Dialysis Start Reset Alarm Alarm Tone Mute Display message Select Confirm Preparation The blood pump starts. Reinfuse the remaining patient blood, until an air detector alarm occurs. (Audible signals are suppressed.) Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Acknowledge by pressing the Confirm key. Confirm Select Reinfusion Override –200 –30 Restart reinfusion by pressing the Test –300 –40 Dialysis Start key. Prime The Dialysis Start LED is illuminated. Dialysis Start Reset Alarm Alarm Tone Mute Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Press the Confirm key. Use the keys to select Confirm Select 2.4 Reinfusion 2.4 Reinfusion. Press the Confirm key. Press the Confirm key. Confirm Select Stop Reinfusion ? Display message Confirm Select Dialysis Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
(Bolus: ml) The operation LED is dark. :h.min) Bolus Rate Start Stop Switch on the blood pump with reduced Rate: ml/min (Ø: mm) blood flow. The operation LED is illuminated. Start Stop 5-10 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Press the Dialysis Start key. Dialysis Start Reset Alarm Alarm Tone Mute Display message Confirm Select Preparation Audible signals are suppressed. Reinfuse the remaining patient blood, until an air detector alarm occurs. 5-11 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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The venous line clamp closes. Disinfection Disconnect the patient on the venous Single side. –10 Needle –100 –20 Override –200 –30 Test –300 –40 Prime Dialysis Start Reset Alarm Alarm Tone Mute 5-12 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Use the keys to select Select Confirm 2. Treatment mode 2. Treatment mode. Press the Confirm key. Use the keys to select Confirm Select 2.4 Reinfusion 2.4 Reinfusion. Press the Confirm key. 5-13 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Press the Confirm key. Select Confirm Are you sure ? Temporary display message Confirm Select Value(s) cleared ! Automatic return Confirm Select 7.1 Reset UF data Press the Confirm key. Confirm Select Reinfusion ? 5-14 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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The operation LED is dark. :h.min) Bolus Rate Start Stop Override –200 –30 Press the Dialysis Start key. Test –300 –40 The Dialysis Start LED is illuminated. Prime Dialysis Start Reset Alarm Alarm Tone Mute 5-15 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Disinfection The venous line clamp closes. Disconnect the patient on the venous Single –10 Needle side. –100 –20 Override –200 –30 Test –300 –40 Prime Dialysis Start Reset Alarm Alarm Tone Mute 5-16 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Drain program in progress. Override –200 –30 The drain program can be skipped by Test –300 –40 pressing the Dialysis Start key a sec- ond time. Prime Dialysis Start Reset Alarm Alarm Tone Mute 5-17 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Note Always clean the sealing area of the connector after dialysis to remove bicarbonate precipitate. Turn the interlock plate 180°. Close the interlock plate. 5-18 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Confirm Select Emptying-program Open the interlock shunt as soon as air bubbles are visible in the outlet line. Place the outlet line on the blue color- coded connection. Close the interlock shunt. 5-19 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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It is imperative to disinfect the ma- chine after each dialysis treatment. Note If the machine has been idle for more than 72 hours, it is recommended to run a disinfection program before ini- tiating the next treatment. 5-20 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Preselection ........................6-27 6.9.3 Start ..........................6-28 6.9.4 Setting the Delivery Rate of the Blood Pump ..............6-29 6.9.5 Delivery Stops ........................ 6-29 6.9.6 Interrupting Precirculation ....................6-30 6.9.7 Premature Termination ....................6-30 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Program Rinse R endless Endless rinse Rinsing clean Hot rinsing Cooling rinse Disinfection D(F) Cleaning Disinfectant is drawn in from the front (concentrate suction tube). HDIS Hot disinfection Mandatory rinse Integrated hot rinsing Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
(option) and advanced hydraulics only: When selecting a cleaning program, a display message will inform the op- erator when the filter needs to be changed. (See Chapter 7.6.1 Indication of a Filter Change.) Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Safe function can then no lon- ger be ensured and the manufacturer shall no longer have any liability. (See DIASAFE ® plus package insert.) Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
During the hot disinfection cycle scalding water or steam may be emitted via the vent tubing. Caution ® Applicable for DIASAFE plus (option) only: High surface temperatures on the DIASAFE ® plus during heat disinfec- tion. Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
The text display indicates the program preset in the SETUP menu, Arterial Venous Transmembrane Air Detector Ultrafiltrat Pressure Pressure Pressure UF Volume e.g. PGM 2: —F—HDIS—M— The program starts automatically after approx. 5 seconds. Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
—F>HDIS<M— : x h xx The Disinfection LED is illuminated. The current temperature can be dis- played by pressing the keys. Mandatory rinse Confirm Select —F—HDIS>M< : x h xx The Rinse LED is illuminated. Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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If the pH is too high (yellow color pH ≤ 4.1), run an rinse program for a minimum of 5 min., then re-deter- mine the pH. Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Press the key of the program step Confirm Select >F<HDIS–M– : 0 h 29 currently in progress, e.g. Rinse, for approx. 2 seconds. Rinse mmHg Hotrinse Blood Leak Disinfection Single –10 Needle –100 6-11 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Note Do not remove the concentrate and bicarbonate suction tubes from their ports to prevent leakage of fluid which might then enter the interior of the machine. 6-12 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Air Detector Ultrafiltrat Pressure Pressure Pressure e.g.: PGM 2: —F—HDIS—M— UF Volume Use the keys to select pro- Confirm Select PGM 5: –F–D(F)–M– gram 5 . The program starts automatically after 5 seconds. 6-13 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Rate the cleaning agent container Start Stop ® (Sporotal 100). Cleaning agent Caution Assure that the container used con- tains sufficient cleaning agent to complete the rinse program. Avoid aspiration of air. 6-14 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Select Conc line not conn The red (alarm) status indicator is illu- minated. The Alarm Tone Mute LED is flashing. Audible signal Insert the red concentrate suction tube in the rinse chamber. 6-15 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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(e.g. with potassium iodide paper) If the test shows a residual concen- tration, the respective rinse program must be restarted. (In this case it is not necessary to run the entire rinse program.) 6-16 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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6.5.3 Stopping the Program (See Chapter 6.4.3 Stopping the Program.) 6-17 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
The text display indicates the program Arterial Venous Transmembrane Air Detector Ultrafiltrat Pressure Pressure Pressure preset in the SETUP menu, UF Volume e.g.: PGM 1: —F—HR—C— The program starts automatically after approx. 5 seconds. 6-18 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
The Rinse LED is illuminated. The Alarm Tone Mute LED is flashing. Select Confirm Cooling rinse end Audible signal Selectable in the SETUP menu. The red (alarm) status indicator is illu- minated. 6-19 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Note Do not remove the concentrate and bicarbonate suction tubes from their ports to prevent leakage of fluid which might then enter the interior portions of the machine. 6-20 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Ultrafiltrat Pressure Pressure Pressure UF Volume preset in the SETUP menu, e.g. PGM 1: —R— The program starts automatically after approx. 5 seconds. 6.7.2 Sequence Confirm Select >R< : x h xx 6-21 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Note Do not remove the concentrate and bicarbonate suction tubes from their ports to prevent leakage of fluid which might then enter the interior portions of the machine. 6-22 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Temporary display message if a rinse Confirm Select Rinse-volume XXXX ml volume was selected in the SETUP. Display message, e.g.: >R< : 0 h 15 Confirm Select >R< : 0 h 15 6-23 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Venous Transmembrane Air Detector Ultrafiltrat Pressure Pressure Pressure UF Volume The Rinse LED is illuminated. Rinse mmHg Audible signal Hotrinse cleared automatically after 2 seconds Blood Leak Disinfection Single –10 Needle –100 6-24 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Continue the priming procedure by Hotrinse pressing the Prime key again. Blood Leak Disinfection Single –10 Needle –100 –20 Override –200 –30 Test –300 –40 Prime Dialysis Start Reset Alarm Alarm Tone Mute 6-25 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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An error message displays in the status Disinfection line. (See Chapter 4.7 Error Messages During Single Cleaning Programs.) –10 Needle –100 –20 Override –200 –30 Test –300 –40 Prime Dialysis Start Reset Alarm Alarm Tone Mute 6-26 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Ultrafiltrat Pressure Pressure Pressure UF Volume Precirculation will be started automat- ically after priming has been com- pleted. Display message e.g.: >R< :0 h 15 Confirm Select >R< : 0 h 15 6-27 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Venous Transmembrane Air Detector Ultrafiltrat Pressure Pressure Pressure UF Volume The Rinse LED is illuminated. Rinse mmHg Audible signal Hotrinse cleared automatically after 2 seconds Blood Leak Disinfection Single –10 Needle –100 6-29 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Hotrinse Blood Leak Continue precirculation by pressing the Dialysis Start key again. Disinfection Single –10 Needle –100 –20 Override –200 –30 Test –300 –40 Prime Dialysis Start Reset Alarm Alarm Tone Mute 6-30 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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....................7-31 Transferring Treatment Parameters (Download) ............7-33 7.8.1 Description ........................7-33 7.8.2 Basic Requirements ....................... 7-33 7.8.3 Important Notes ......................7-34 7.8.4 Procedure ........................7-35 7.8.5 Aborting the Data Transfer ..................... 7-38 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Press the Confirm key. Confirm Select 5.1 Brightness Use the keys to change the Confirm Select set Brightness brightness of the display. Press the Confirm key. The setting is effective for the treatment in progress. Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Use the keys to select Confirm Select 5.3 Key-click 5.3 Key-click. Press the Confirm key. Use the keys to set the desired mode (on/off) . Confirm Select Key-click is on Press the Confirm key. Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
04.02.11 value of the flashing digits (month). Press the Select key. Use the keys to adjust the Confirm Select 09 : 14 04.02.94 value of the flashing digits (year). Press the Confirm key. Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
04.11 value of the flashing digits (day). Press the Select key. Use the keys to adjust the Confirm Select 19 : 30 04.12 value of the flashing digits (month). Press the Confirm key. Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
4. Bloodflow.calc.. Press the Confirm key. Use the keys to select Select Confirm 4.2 Total bld.volume 4.2 Total bld.volume. Press the Confirm key. Temporary display message, e.g. Confirm Select Cum.bloodvol. 9.5 l 7-10 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Press the Confirm key. Use the keys to select Select Confirm 7.4 Show eff. time 7.4 Show eff. time. Press the Confirm key. Temporary display message, e.g. Confirm Select Eff. time 0:35h 7-11 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Confirm Select 7.5 Clear eff. time 7.5 Clear eff. time. Press the Confirm key. Press the Confirm key. Confirm Select Are you sure ? Temporary display message Confirm Select value(s) cleared ! 7-12 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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DIASAFE – Only use filters with undamaged packaging. – Remove the packaging and the protective straps only immediately before installing the filter. – Only touch the connectors if re- quired. 7-13 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Fresenius Medical Care 4008 B Turn the hemodialysis machine off! The I/O LED stops lighting. Arterieller Luftdetektor Druck Open the locking levers. Slide the used filter upwards and out of the guide slot. 7-14 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Remove the protective straps from the new filter by pulling the lug. Slide the new filter from the top into the guide slot. Close the locking levers. 7-15 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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The Test LED is flashing. Test –300 –40 If the Test LED is not flashing, one of the conditions for the test to start is not Prime fulfilled. Dialysis Start Reset Alarm Alarm Tone Mute 7-16 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Then run a heat disinfection program or a dis- infection program followed by a hot rinse. Caution Run a disinfection program after each filter change. 7-17 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
100 is restricted to a maximum PGM 3: –F–D–M–HR of 11. (Numbers displayed: 11 to 01). Press the Confirm key to select the Confirm Select PGM 4: –F–HDIS–M–HR cleaning program. Confirm Select FILTER max. Cle.: 7-18 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Press the Confirm key to change the fil- ter (see Chapter 7.6.3 Changing the Fil- ter) Confirm Select PGM 4: –F–HDIS–M–HR press the key to select a dif- ferent cleaning program. Confirm Select Filter change ! 7-19 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Press the Confirm key to change the fil- Select Confirm Filter change ! ter (see Chapter 7.6.3 Changing the Fil- ter) select the desired cleaning program to override the filter change. (See Chapter 7.6.2 Overriding a Filter Change.) 7-20 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Press the Confirm key to change the fil- Confirm Select Filter change ! ter (see Chapter 7.6.3 Changing the Fil- ter) select the desired cleaning program to override the filter change. (See Chapter 7.6.2 Overriding a Filter Change.) 7-21 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Press the Confirm key to change the fil- ter (see Chapter 7.6.3 Changing the Fil- ter) Confirm Select Filter change ! select the desired cleaning program to override the filter change. (See Chapter 7.6.2 Overriding a Filter Change.) 7-22 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Overrding a Filter Change Select the desired cleaning program to override a filter change. If the filter is not changed, treatment can be initiated without the advantages of the ® plus . DIASAFE 7-23 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
DIASAFE – Only use filters with undamaged packaging. – Remove the packaging and the protective straps only immediately before installing the filter. – Only touch the connectors if re- quired. 7-24 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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5. System parameter 5. System parameter. Press the Confirm key. Use the keys to select Select Confirm 5.5 Filter change 5.5 Filter change. Press the Confirm key. Display message Confirm Select Empty filter 7-25 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Select Filter changed ? emptied. Open the locking levers. Slide the used filter upwards and out of the guide slot. Remove the protective straps from the new filter by pulling the lug. 7-26 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Slide the new filter from the top into the guide slot. Close the locking levers. Press the Confirm key to confirm the Confirm Select Filter changed ? filter change. 7-27 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Message displayed while the filter is be- Confirm Select Filling filter ing filled. When the filter has been filled, the disin- fection program defined in the SETUP will be started automatically. Caution Disinfect after each filter change. 7-28 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Empty BIBAG? with the Conf key. Note Do not remove the bicarbonate suc- tion tube from its port to prevent lea- kage of fluid which might then enter the interior portions of the machine. 7-29 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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If the interlock plate does not move to ® the front, the bi b ag can be removed by slightly turning the bag. Turn the interlock plate 180°. Close the interlock plate. 7-30 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
® connecting the bi b ag Press the unlock pad to open the inter- lock plate. Turn the interlock plate 180°. Remove the foil from the bi b ag ® 7-31 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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(last- ing approx. 35 secs). This program will first remove all air from ® the biBag and will then fill the bag with water. 7-32 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
After the treatment parameters have been transferred, the downloaded data can only be accepted on the dialysis machine, provided: the UF unit has been switched off. the UF volume has been set to 0000. 7-33 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Conf. key. Note If parameters are changed before the data are accepted, other parameters may also change. (e.g.: A change of the UF time will cause a change of the UF rate). 7-34 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Check the transferred UF parameters on Ultrafiltration the ultrafiltration monitor. UF Volume 0000 Reset Volume UF Rate ml/h 0750 UF Goal 3000 Time Left h:min 4:00 Prog. Press the Conf. key. Confirm Select UF parameters OK? 7-35 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Displayed only if no UF profile was se- lected. Press the Conf. key. Display message Select Confirm Na+ Profile Off Displayed only if no Na profile was se- lected. Press the Conf. key. 7-36 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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Temporary display message Confirm Select Profiles ready Displayed only if UF profiles and/or profiles were selected. Display message Confirm Select Preparation Displayed when all downloaded data have been saved. 7-37 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
Press the Select key. Confirm Select Prescr. Na+ xxx mmol Display message Confirm Select Are you sure ? Press the Conf. key. Select Confirm Are you sure ? All downloaded treatment parameters will be erased. 7-38 Fresenius Medical Care 4008 B 18/10.11 (OP-EN)
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