MARS Monitor 1 TC and MARS TREATMENT KIT Operating Instructions sw 4.04.15 Edition June 2012

Symbols In these Operating Instructions, safety regulations and instructions are identified and

by

.

WARNING WARNING

A Warning alerts the reader about a situation which, if not avoided, could result in death or serious injury. It may also describe potential serious adverse reactions and safety hazards. CAUTION

PRECAUTION CAUTION

The Word CAUTION is generally used as the signal ��������������� word for a precaution statement. The term Precaution is used for the statement of a hazard alert that warns the reader of a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or damage to the equipment or other property. NOTE This symbol identifies advice and/or information for better understanding, for economical use, or for simplified operating steps. CROSS-REFERENCE This symbol identifies a cross-reference to a chapter, a section, a page, or a figure in these Operating Instructions.

NOTE * Install the treatment kit! * Close all clamps in the albumin circuit!

Proceed Menu Proceed Menu

This box with varying contents represents messages and other information shown on the LC display of the MARS® Monitor. If you follow the procedures described in the manual, the contents of these boxes correspond with those shown on the LC display of the MARS® Monitor. Manufactured for:

Gambro Lundia AB Box 10101 Magistratsvägen 16 SE-220 10 Lund, Sweden Phone: +46 46 169000 e-mail: [email protected] Please also visit our website: www.gambro.com

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0.

Symbols... 0 - 2

1.

Description and Application... 1 - 1

1.1

General Description and Application... 1 - 1

1.2

MARS® Monitor 1TC... 1 - 2

1.3

1.2.1

Description of the MARS® Monitor... 1 - 6

1.2.2

Rear View ... 1 - 9

1.2.3

Display, Indicator and Control Module . ... 1 - 11

1.2.4

User Guide... 1 - 15

1.2.5

Monitored Functions ... 1 - 19

MARS® Treatment Kit... 1 - 22 1.3.1

Description of Kit Components... 1 - 23

2.

Instructions on Use and Saftey... 2 - 1

2.1

Indications and Contraindications... 2 - 1 2.1.1

Indications... 2 - 1

2.1.2

Contraindications... 2 - 1

2.1.3

Clinical side effects... 2 - 2

2.2

The Manufacturer‘s Responsibility... 2 - 3

2.3

Transport, Setup and Initial Startup... 2 - 4 2.3.1

Transport... 2 - 4

2.3.2

Setup... 2 - 5

2.3.3

Initial Startup... 2 - 7

2.4

Use of Consumables and Accessories... 2 - 8

2.5

Operation... 2 - 10

2.6

2.5.1

General Notes. ... 2 - 10

2.5.2

Unit-Specific Instructions... 2 - 11

Life Cycle, Recycling, Disposal ... 2 - 12

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Table of Contents

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Table of Contents

Treatment Preparation... 3 - 1

3.1

Turning the MARS® Monitor on... 3 - 1

3.2

Inserting the Treatment Kits in the MARS® Monitor and the Dialysis Machine ... 3 - 2 3.2.1

Inserting the MARS® Treatment Kit... 3 - 3

3.2.2

Installing the Line Set of the Hemodialysis Machine... 3 - 10

3.2.3

Connecting the Systems... 3 - 11

3.3

Priming the Blood and Dialysate Circuits... 3 - 12

3.4

Automatic Preparation... 3 - 14

3.5

Manual Preparation... 3 - 21

4.

Treatment... 4 - 1

4.1

Starting the Treatment... 4 - 1

4.2

Treatment... 4 - 2

4.3

Terminating the Treatment... 4 - 4

4.4

Cleaning the Unit... 4 - 4

5.

Information on Use of the MARS® Prismaflex Combination... 5 - 1

5.1

MARS® Set Up... 5 - 2

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5.1.1

Setup of Disposable on MARS® Monitor... 5 - 2

5.1.2

Setup of Disposable on Prismaflex... 5 - 8

5.1.3

Connect Prismaflex & MARS®. ... 5 - 9

5.1.4

Prepare and Connect Solutions... 5 - 10

5.1.5

Priming of Blood and Dialysate Circuits... 5 - 11

5.1.6

Priming of MARS® Circuit... 5 - 12

5.1.7

Prime Test on Prismaflex Device... 5 - 13

5.1.8

Albumin Filling... 5 - 14

5.1.9

Connect Patient... 5 - 15

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3.

Treatment... 5 - 15

5.3

Terminating the Treatment... 5 - 18

6.

Alarms and Error Messages... 6 - 1

6.1

Alarms

6.2

Error Messages... 6 - 3

7.

System Compatibility... 7 - 1

7.1

Examples of System Combinations... 7 - 3

8.

Maintenance and Technical Saftey Checks... 8 - 1

9.

Technical Data... 9 – 1

10.

Appendix ... 10 - 1

10.1

Guidelines and Manufacturer‘s Declaration ... 10-3

10.2

Recommended Separation Distances... 10-7

10.3

Clinically Relevant Drugs with High Binding

. ... 6 - 1

Capacity to Proteins in Plasma ... 10-9 10.4

Suggestions for Improvement ... 10-11

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Table of Contents

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5.2

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Page not printed deliberately

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Description and Application 1.1

General Description and Application

The MARS® Monitor 1 TC described in these Operating Instructions forms the technical equipment for a special type of extracorporeal blood treatment, which is called the MARS® procedure (Molecular Adsorbents Recirculating System). This procedure combines the removal of water-soluble and albumin-bound toxins from patient blood in an optimal manner. Unlike the dialyzable uremic toxins of patients with liver disease, the toxins accumulating in the blood of liver patients cannot be filtered because they bind to blood proteins. For that reason, a new technology is used to selectively remove the albumin-bound small and mediumsized toxins. This new technology is characterized by the patient’s blood being ® passed through a special hollow-fiber filter (MARS FLUX), in a manner analogous to conventional hemodialysis. In the MARS® procedure, the washing solution (dialysate) used on the outside of this hollowfiber membrane is an albumin solution usually with a concentration of no more than 20 %.

Via the special hollow-fiber-membrane polymers, the albumin dialysate can bind the toxins from the blood albumin through the membrane. In addition, the aqueous albumin dialysate permits dialysis of low-molecular uremic toxins. After the toxins have been eliminated from the patient’s blood, the albumin dialysate is cleaned. To achieve this, the water-soluble toxins are removed via a second hollow-fiber dialyzer (diaFLUX) and, subsequently, the albumin-bound toxins are bound to special adsorption columns (activated charcoal and an ion exchanger). ® The toxin-free albumin is returned to the MARS FLUX filter in a recirculating system. The therapy is based on the elimination of the water-soluble and protein-bound toxins that are accumulating in cases of a liver failure. This improves the requirements for potential regeneration of the liver cells, while reducing the toxicity of the plasma. The therapeutic aim depends on the particular indication.

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Description and Application

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1.

MARS® Monitor 1TC

The MARS® Monitor 1TC is an addition to hemodialysis machines allowing the removal of protein-bound toxins that have accumulated in the blood (albumin dialysis). The monitor can be operated in combination with selected intermittent as well as continuous hemodialysis machines.

hemo-dialyzer

➔Fig. 1-1 illustrates the setup of a conventional dialysis procedure in simplified form.

Fig. 1-1:

Conventional dialysis procedure; blood and dialysate circuits

The MARS® Monitor is fitted with the MARS® Treatment Kit which establishes what is called the albumin circuit ➔Fig. 1-2. When MARS® therapy is performed, the blood and dialysate circuits are still operated and monitored by the hemodialysis machine used. An example of a possible combination is shown in ➔Fig. 1-3.

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Description and Application

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1.2

Fig 1-2:

Absorber ® diaMARS AC250 Tubing kit

MARS® treatment

The additional albumin circuit in the MARS® procedure is operated as a recirculating system, permitting performance of a renal replacement therapy simultaneously with the MARS® treatment. In other words, it permits dialysis of water-soluble toxins and controlled fluid removal (ultrafiltration) as well as postdilution and predilution. Essentially, the MARS® Treatment Kit consists of the following components: • MARS® FLUX and diaFLUX filters

• diaMARS® AC250 and diaMARS® IE250 adsorber cartridges • Tube kit incl. waste and optional heater bags Two different filters are used in the MARS® treatment. Both low-molecular and water-soluble as well as albumin-bound toxins are transported from the blood to the albumin circuit via the MARS® FLUX filter which is in contact with the patient blood. The second diaFLUX filter serves to remove the low-molecular and water-soluble toxins from the albumin circuit. Since the MARS® procedure uses a recirculating system, the binding capacity of the albumin dialysate must be maintained continually. This is achieved by means of adsorbtion columns in a dual-stage procedure. The first stage uses an activated-carbon adsorber (diaMARS® AC250) to bind non-ionic toxins. In the second stage, the toxins still bound to the albumin are bound by an ion exchanger (diaMARS® IE250) (➔ Section 1.3.1). The albumin so treated flows into the MARS® FLUX filter.

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Description and Application

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Filter diaFLUX

Filter ® MARS FLUX Heater bag (optional) Absorber ® diaMARS IE250

The albumin circuit of the MARS® Monitor is activated by the albumin pump whose flow rate can be specified directly via the control module. The optimum flow rate is automatically preset during the preparation mode. It is, of course, also possible to stop and restart the pump manually. Over and above this, the pIN and pOUT pressures (measured at two points in the albumin circuit) directly affect pump function. If the pressure measured in the albumin circuit exceeds or falls below the pIN limit specified on the control module, the albumin pump is stopped immediately. An optimal course of therapy, easy handling, and high patient safety were the focal points in the development of the MARS® Monitor. For that reason, the unit has been provided with two optical sensors having the following functions: • The blood leak detector permanently monitors the albumin dialysate coming from the MARS® FLUX filter for blood constituents. If a maximum concentration adjusted to the albumin flow rates is exceeded, an alarm is initiated. The venous line clamp will also be closed to get the ultrafiltration rate back to a low level by stopping the hemodialysis machine. • The level detector of the drip chamber permanently monitors the fluid level in the chamber. If it is too low, the level is automaticallyraised to the correct value. At one of its sides, the MARS® Monitor 1TC is provided with a heater bag that can be used optionally. A microprocessor-controlled heater controller gives the possibility to heat the albumin dialysate to any temperature within a range from 35 to 38 °C. In the MARS® treatment preparation phase, the basic hemodialysis machine is prepared and the MARS® Treatment Kit is installed and primed. The priming process is largely performed automatically by the MARS® Monitor, thus considerably relieving the nursing staff. It is also possible to prime the MARS® Treatment Kit manually by separately confirming each step.

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Description and Application

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Apart from allowing the use of the MARS® Treatment Kit, the MARS® Monitor controls and regulates all relevant treatment parameters of the albumin circuit. To this end, the unit is equipped with a microprocessor system continuously monitoring all primary states and functions. As a result, any errors in operation and treatment as well as machine malfunctions are detected and indicated to the user both visually and audibly. A display, indicator and control module integrated in the MARS® Monitor is provided as interface between the user and the unit. Simple and safe operation of the unit is ensured by an appropriate combination of LC display, status LEDs, and flat touch panel.

While treatment is in progress, the blood is detoxified in the extracorporeal circuit as described in ➔Section 1.1. The treatment time can be selected as required, depending on the indication (max. 24 h). If you use the optional heater, the temperature of the albumin dialysate is adjusted on start of the treatment. You can only use the heater, if you have inserted the heater bag in the kit and have installed it in the heater flap during the preparation phase. Please activate the heater via the menu. The menu also allows you to change the desired temperature or to deactivate the heater during treatment. Neither is it required to replace priming solutions or the like on the MARS® Monitor, owing to the recirculating procedure. As a result, the MARS® Monitor requires only a low level of attention during treatment.

Fig. 1-3:

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MARS® Monitor 1TC, combined with the Prisma system (Gambro)

Description and Application

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After completion of the preparation phase, the MARS® Monitor can be switched off, if desired, and put into operation again at a different site without having to be subjected to the preparation process again. If the therapy is interrupted for more than 2 hours, the preparation phase must be repeated before the treatment is started.

Description of the MARS® Monitor Air trap holder with Level monitoring system

Holder for particle filter Adsorber output pressure pOUT

Adsorber input pressure pIN

Bag holder

Blood leak detector

Holder for MARS® FLUX filter

Holder for small air trap

Holder for diaFLUX filter

Pin for opening the heater flap Albumin dialysate heater

Albumin pump ®

Holder for diaMARS IE250 ion-exchanger adsorber Adsorber line clamp IE250 Venous line clamp

Fig. 1-4:

Holder for diaMARS® AC250 activated-carbon adsorber Adsorber line clamp AC250

Front view of the MARS® Monitor 1 TC

Pressure connector for adsorber input pressure pIN Luer-lock connector for measuring the pressure upstream of the adsorber cartridges. The decisive factor for defining the input and output is the preferred pumping direction in the albumin circuit. This connector must be connected to the appropriate counterpart in the MARS® Treatment Kit. The pIN pressure is indicated on the display (LEDs) and monitored by means of adjustable limits. Pressure connector for adsorber output pressure pOUT Luer-lock connector for measuring the pressure downstream of the adsorber cartridges. The decisive factor for defining the input and output is the preferred pumping direction in the albumin circuit (also see the arrow on the pump rotor). This connector must be connected to the appropriate counterpart in the MARS® Treatment Kit.

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Description and Application

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1.2.1

The albumin pump serves to fill and activate the albumin circuit. The red arrow on the pump rotor marks the preferred pumping direction in the circuit (counter-clockwise). The range of delivery of the pump is 50–250 ml/min. Blood leak detector Optical sensor system, monitoring the albumin dialysate coming from the MARS® FLUX filter for blood constituents. The connection line between the MARS® FLUX and diaFLUX filters must be installed in the blood leak detector. At the beginning of the treatment, the sensor checks whether this line is present. Venous line clamp This clamping device is required for installing the venous leg of the blood circuit of the basic hemodialysis system. Please insert the blood line in the clamp downstream of the venous pressure transducer of the hemodialysis machine. In case of a blood leak alarm, the MARS® Monitor 1TC closes this clamp, thus initiating an alarm at the primary hemodialysis machine and stopping ultrafiltration. At the beginning of the treatment, this clamp is checked for presence of a blood line. Air trap holder with level detector Holding device for the large-size air trap (air trap 2) of the MARS® Treatment Kit. This air trap is provided for preventing air from entering the adsorber cartridges by selective air separation. The level is set automatically by a level detector. Adsorber line clamp AC250 Clamping device for the connection line between the activated-carbon adsorber AC250 and the particle filter. The line clamp is actuated automatically during the priming process in the preparation phase. It is checked for presence of a line. Adsorber line clamp IE250 Clamping device for the connection line between the ion-exchange adsorber IE250 and the heater bag. The line clamp is actuated automatically during the priming process in the preparation phase. It is checked for presence of a line. Holder for MARS® FLUX dialzyer Holder for the MARS® FLUX filter which comes into contact with blood on the inside and with albumin dialysate on the outside of its hollowfiber membrane.

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Description and Application

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Albumin pump

Holder for the diaFLUX filter which comes into contact with albumin dialysate on the inside and with conventional dialysate on the outside of its hollow-fiber membrane. Holder for small air trap Holder for small air trap of unit 1. Holder for diaMARS® AC250 activated-carbon adsorber Holder for the AC250 activated-carbon adsorber which is inserted from above. A colored mark (black circle) on the bottom of the holder helps to prevent mistakes. When inserting the adsorber, observe the flow direction printed on the cartridge label. Holder for diaMARS® IE250 ion-exchange adsorber Holder for the IE250 ion-exchanger adsorber which is inserted from above. A colored mark (white circle) on the bottom of the holder helps to prevent mistakes. When inserting the adsorber, observe the flow direction printed on the cartridge label. Holder for particle filter Holder for the primed particle filter. When inserting the particle filter, observe the flow direction printed on the label. Albumin dialysate heater (optional) Device for controlled heating of the albumin dialysate. The heater has been designed to compensate heat losses in the albumin circuit. Unless medical indications suggest otherwise, the dialysate heater of the dialysis machine must be switched on to prevent the patient from cooling during treatment. We recommend that you set the dialysate temperature of the dialysis machine to 37 °C. If you intend to use the optional albumin dialysate heater, insert the heater bag (included in the accessories) in unit 4 in the preparation phase. Insert the heater bag between the two heater plates and close the heater flap until the lock clicks into place. Make sure that the heater bag abuts smoothly against the heater plates and is prevented from kinking. The heater flap can be opened either electrically via the operator module or manually at the flap itself. If you use a monitor produced before February 2002 that has not been updated yet, the heater flap can be opened only with the help of, e.g., a paper clip. Insert the clip in the small hole on the front of the flap and exert a slight pressure to unlock it. Bag holder Rack for suspension of the priming and waste bags required for the priming process.

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Description and Application

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Holder for diaFLUX filter

Please note that, to perform the automatic priming mode, the waste bags must always be suspended from this bag holder. Suspend the priming bag and the large-size waste bag from the left side and the small-size waste bag from the right side of the rack of the MARS® Monitor.

1.2.2

Rear View RS232 interface

Fig. 1-5:

Nurse call connector

Equipotential bonding

Type label

Main switch, power supply connection, furses, cable grip

Rear view

The MARS® Monitor 1 TC is provided with connectors to a personal computer (via the serial RS232 interface), and to the nurse call. Power supply connection with main switch and fuse Power connection module with main switch and fuse Connect the supplied power cable to this module, and secure the cable by pressing the cable grip onto the cable from above. The power cable of monitors that were produced or updated after April 2004 is additionally secured with a clip. NOTE The line voltage used must be identical with that specified on the type label.

Actuate the main switch to make the MARS® Monitor ready for operation (-> the green lamp of the main switch is lit).

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Description and Application

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NOTE

Connector for a nurse call system used in the hospital. By means of this interface, the MARS® Monitor can initiate the nurse call in case of an alarm or error. Equipotential bonding Connector used to connect the MARS® Monitor to the equipotential bonding available in the room where it is set up. RS232 interface Port for connecting the MARS® Monitor to a personal computer or a laptop. This interface is intended for service technicians for executing diagnosis functions and for updating the software. NOTE If it is not used, the port must be protected against damage by electrostatic discharge by means of the supplied cover. NOTE Under no circumstances may a conventional printer be connected to this interface. If unused, this port must be protected from all damage through electrostatic discharge by means of the cover supplied.

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Description and Application

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Nurse call connector

Display, Indicator and Control Module

The display, indicator and control module provides quick information on the current operating state and permits entry and alteration of data during the course of therapy. Indicator BLOOD LEAK ALARM LCD Display

LED / button AUTOMATIC PREPARATION

POWER button LED PRESSURE DISPLAY Adsorber inlet pressure pIN

BUTTONS FOR SETTING PRESSURE LIMITS of pIN MENU SELECT / CONFIRM (ENTER) buttons

Fig. 1-6:

QMF 3-4-41_6.1 EN Edition 06/2012

ALARM LED / ALARM AUDIO PAUSED button

LED / button START / STOP Albumin pump

FLOW RATE selector buttons FLOW RATE DISPLAY for albumin pump

Display, indicator and control module

Description and Application

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1.2.3

The POWER BUTTON serves for switching the unit ON and OFF. After you have activated the POWER SWITCH on the rear of the unit, the green LED in the left upper corner of the POWER BUTTON is lit; press the button only briefly to switch the unit on. NOTE Pressing the POWER BUTTON for more than one second when turning on the MARS® monitor, will cause the power supply unit to turn off again. Wait at least 6 seconds for the monitor’s internal power supply to reset, and briefly press the POWER BUTTON again to resume power. Press the POWER BUTTON for approx. 3 seconds to turn the unit off. Always turn off the front POWER BUTTON first before switching off the green POWER SWITCH from behind the unit, to avoid power interrupt alarms. CAUTION PRECAUTION CAUTION

Never turn off the main switch on the rear of the unit as long as the monitor is in operation, since otherwise the MARS® Monitor detects a voltage failure and switches over to the battery mode. START/STOP The START/STOP button is pressed during the preparation or treatment phase, to switch the albumin pump on and off. If the pump is running, the active-mode indicator to the left of the START/STOP button is lit during operation, and flashes when paused. In treatment mode, there is an audible “START PUMP” alarm, after 2 minutes of idle pump time. NOTE If you wish to prematurely stop a current preparation or treatment, you must always switch off the albumin pump first, using the START/STOP button. AUTOMATIC PREPARATION NOTE The AUTOMATIC PREPARATION function only works with the preselected preparation modes, cont. standard and int. standard. It is not available for use with Mode 1, Mode 2, or Mode 3 (Prisma). The AUTOMATIC PREPARATION button starts the automatic preparation mode. The active-mode indicator to the left of the button is lit in the automatic (and manual) preparation mode.

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Description and Application

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POWER

In the preparation mode, the albumin pump can be activated and deactivated with the START/STOP button. To start manual preparation, press the cursor keys and select the PREPARATION item from the main menu. ALARM / ALARM AUDIO PAUSED If an alarm occurs, the albumin pump stops immediately and the alarm indicator flashes. An audible alarm signal is also emitted. Pressing the alarm confirm button suppresses the audible alarm for 2 minutes. NOTE The alarm indicator turns dark only after the cause of the alarm has been eliminated. Otherwise, another alarm is emitted within 2 minutes. If the alarm cause has been eliminated before the alarm is confirmed, the alarm is acknowledged automatically. The alarm cause is shown on the LC display until the START/STOP button is pressed. BLOOD LEAK ALARM If a blood leak occurs, the BLOOD LEAK ALARM symbol is lit in addition to the ALARM indicator (bell symbol). The venous line clamp will also be closed to get the ultrafiltration rate back to a low level by stopping the hemodialysis machine. WARNING WARNING

After a blood leak alarm has been detected, please check whether blood constituents have entered the albumin circuit. If you have verified that no blood has entered the albumin circuit, you can re-initialize the blood leak detector. If necessary, replace the MARS® Treatment Kit and restart the preparation process of the MARS® therapy as described in Section 3. ALBUMIN PUMP FLOW RATE DISPLAY The FLOW RATE DISPLAY shows the current flow rate of the albumin pump. The FLOW RATE SELECTOR BUTTONS below the display can be used to set the flow rate of the albumin pump to values within a range of 50 to 250 ml/min.

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Description and Application

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NOTE

The buttons for SETTING THE PRESSURE LIMITS can be used to define the limits for the adsorber input pressure pIN. Press the arrow buttons to shift the range of pressure limits. If you press the central button and the arrow-up or arrow-down button simultaneously, you can increase or reduce the range of the pressure limit respectively. WARNING WARNING

To manually change the pressure alarm set point, please ensure that the difference between the current pressure and the lower alarm set point does not exceed 100 mmHg. NOTE If the defined limits are exceeded, a pressure alarm is initiated and the albumin pump is stopped.

Main menu

LC display

Preparation ->Cont. standard Treatment Configuration Open heater

MENU SELECT / CONFIRM (ENTER) The MENU SELECT / CONFIRM buttons can be used to select and confirm individual menu items and modify parameters on the display.

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Description and Application

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BUTTONS FOR SETTING THE PRESSURE LIMITS