Aquarius Operators Manual Ver 4 Rev C May 2004

Table of Contents 1.

2.

GETTING STARTED WITH AQUARIUS... 1 1.1.

Setting Up ... 1

1.2.

Installation ... 1

1.3.

Equipment: Disposables and Consumables... 1

1.4.

Waste Management... 2

1.5.

Materials Used ... 2

1.6.

Transport and Storage ... 2

1.7.

Packing... 3

1.8.

Service... 3

1.9.

Set time and date... 3

INTRODUCING AQUARIUS ... 4 2.1.

General Machine Description ... 4

2.2. Proper Usage / Fields of Application... 8 2.2.1. SCUF (Slow Continuous Ultra-filtration):... 8 2.2.2. CVVH (Continuous Veno-Venous Hemofiltration):... 9 2.2.3. CVVHD (Continuous Veno-Venous Hemodialysis):... 10 2.2.4. CVVHDF (Continuous Veno-Venous hemodiafiltration):... 11 2.2.5. TPE (Therapeutic Plasma Exchange):... 12 2.2.6. Hemoperfusion (Blood Detoxification):... 13 2.3.

Labelling... 14

2.4.

Side Effects, Contraindications ... 15

2.5.

Safety Instructions and Warnings ... 15

2.6. Operational Sequence (Modes)... 16 2.6.1. System test ... 16 2.6.2. System test failed... 16 2.6.3. Preparation ... 16 2.6.4. Priming... 17 2.6.5. Clamp & Pressure Test... 17 2.6.6. Recirculation ... 17 2.6.7. Connecting the Patient... 17 2.6.8. Treatment ... 18 2.6.9. Disconnecting the Patient ... 18 2.6.10. Terminating the Treatment... 18

3.

2.7.

Operating Concept ... 18

2.8.

Safety Concept ... 21

Performing a Treatment with AQUARIUS ... 22 3.1.

Preparing AQUARIUS... 22

3.2.

Priming mode - Priming the AQUARIUS... 24

3.3.

Recirculation mode - Recirculating saline solution ... 25

3.4.

Programming - Entering Patient Parameters ... 26

3.5. Start Connection - Connecting the Patient ... 26 3.5.1. Single connection... 26 3.5.2. Double connection ... 27 3.6.

Treatment mode - Description of functions throughout Treatment... 27

3.7.

Access Disconnection and Return Disconnection - Disconnecting the Patient ... 29

3.8.

Treatment end - End of Treatment ... 30

3.9. AQUARIUS Therapies Choices ... 30 3.9.1. SCUF (Slow continuous ultrafiltration) ... 31 3.9.2. CVVH (Continuous veno-venous hemofiltration) ... 32 3.9.3. CVVHD (Continuous veno-venous hemodialysis)... 34 3.9.4. CVVHDF (Continuous veno-venous hemodiafiltration)... 35 3.9.5. TPE (Therapeutic plasma exchange)... 37 3.9.6. Hemoperfusion... 38 4.

AQUARIUS Alarms and Messages... 39 4.1.

Description of Alarm Operation ... 39

4.2. Alarms, Messages, System Errors, and Removal Options... 39 4.2.1. Alarms... 39 4.2.2. Messages ... 42 4.2.3. System Errors ... 44 5.

6.

AQUARIUS Technical Data ... 47 5.1.

Dimensions and Weight... 47

5.2.

Electrical Power Supply... 47

5.3.

Electrical Safety... 47

5.4.

Power Outage Operation ... 48

5.5.

Technical Data of Individual Components ... 48

AQUARIUS Cleaning and Disinfection... 51 6.1.

Cleaning ... 51

6.2.

Disinfection... 51

7.

AQUARIUS Warranty and Liability ... 52

8.

Appendix ... 53 8.1.

References ... 53

1.

GETTING STARTED WITH AQUARIUS

1.1.

Setting Up Personnel authorised by the manufacturer must perform set up and installation of the AQUARIUS system, according to the requirements. When setting up the AQUARIUS system, the room and the necessary power installations must comply with the currently valid standards. Line voltage must conform to the data specified on the data plate of the AQUARIUS system. Before putting the AQUARIUS system into operation carefully read the complete operating manual.

1.2.

Installation Before operating the AQUARIUS system for the first time, ensure that the system is complete and that all parts have been delivered with it. If the AQUARIUS system is damaged, do not put it into operation. In this case, notify the service technician responsible for this system. The AQUARIUS system may only be set up and installed by qualified staff authorized by the manufacturer. Authorized staff together with the prescribing physician may do basic modifications of particular settings that do not change the safety concept of the AQUARIUS system.

1.3.

Equipment: Disposables and Consumables The AQUARIUS system is designed to operate exclusively with the standard disposables and consumables intended for the indicated treatments. Follow the instructions for use provided by the manufacturer. Warning: Use only the tubing sets stated below to ensure the proper operation of the AQUARIUS system. Item

Description

Manufacturer

Tubing set

Code: AQUALINE Adult Standard line set Extracorporeal volume (Blood circuit) = 100 ml Code AqualineS Pediatric line set Extracorporeal volume (Blood circuit )= 64 ml

Haemotronic

Tubing set

Haemotronic

Hemofilters, plasma filters, hemoperfusion cartridges and solutions to be used with the AQUARIUS system must conform to applicable standards. Use only products with blood port connections compatible with ISO 594 (Part 1+2) female Luer lock connectors, and connections of dialysate, filtrate and plasma ports compatible with male Luer lock connectors. Use catheters according to the instructions provided by the manufacturer; the catheter connector has to be compatible with male Luer locks. Use only hemofilters that are CE marked, according to the Medical Device Directive (93/42/EWG) and are registered for the indications CVVH, CVVHD and CVVHDF. For hemofilters do not exceed a maximum pressure of 400 mmHg to avoid pre-filter pressure alarms. Maximum TMP is 400 mmHg. Caution: Risk of plasma filter damage. For plasma filters do not exceed a pressure of 100 mmHg .This alarm limit is preset in TPE therapy mode.

Page 1 of 53

Replacement solutions and dialysate have to be sterile and must meet PH. Eur. requirements. Use only 4.5 litres or 5 litres bags with female Luer lock connectors or a sterile adapter to male Luer lock. The prescribing physician must define concentration and composition requirements. Caution: Never use solutions of different compositions simultaneously with the AQUARIUS system! For information on disposables and consumables supplied and recommended by Edwards Lifesciences please contact your Edwards Representative or call Edwards Customer Service.

1.4.

Waste Management The AQUARIUS system and used disposables should be disposed of according to the local provisions. The system must be cleaned before disposal to prevent biohazardous risks. Electronic components of the AQUARIUS system must be disposed of, according to currently valid regulations for the disposal of electronic components. For more information on disposal please contact the system manufacturer: Edwards Lifesciences Services GmbH Edisonstr. 6 85716 Unterschleißheim Germany

1.5.

Materials Used The patient's blood does not have contact with the components of the AQUARIUS system, thus there is no danger of infection for patients, operators or other persons dealing with the system and there are no special requirements regarding the biocompatibility of the materials used for manufacturing this system. All tubing sets through which blood circulates, must be discarded after every treatment (refer section 1.3). This is also true for the integrated transducers that separate and protect the pressure sensors of the AQUARIUS system by means of an impermeable membrane.

1.6.

Transport and Storage To move or transport the AQUARIUS system it is necessary to release the locking tabs on the wheels. The AQUARIUS can then be rotated and freely moved about. To move the AQUARIUS system over steps or stairs the locking tabs must be released. The system should be tilted, lifted, and carried by at least three peoples. Never carry the AQUARIUS system holding on to the display, the I. V. pole, or the scale. The AQUARIUS system must not be pushed over uneven floors. The following environmental conditions are required when storing and transporting the AQUARIUS system: Relative humidity: 30 to 80%, non-condensing Ambient temperature: -5 to +45°C (23 to 113°F) Ambient air pressure: 50 to 105 kPa The AQUARIUS system must be stored in a room with good ventilation facilities and little temperature variations.

Page 2 of 53

1.7.

Packing Within the land where AQUARIUS is manufactured the system will be mounted and fixed and carried on special pallets. For special shipments, a box bearing all safety-relevant labels will be used.

1.8.

Service The AQUARIUS system is subject to technical safety checks and maintenance between 6 month and 12 month intervals. Only qualified service staff, authorized by the manufacturer, must carry out this maintenance and any other repair work. Any work done by non-qualified and non-authorized personnel immediately voids all warranties. More detailed information on the safety check and maintenance can be obtained from Edwards Lifesciences Technical Service: Tel: 0870 6062040 – option 4.

1.9.

Set time and date When help screen is opened, it is possible to set time and date by selecting Set time and date key. • Turn selector button to see set time and date key highlighted. • Press selector button to validate. • Select value to be change by turning the selector button until the value key is highlighted. • Press selector button to validate. • Press the selector button when the value reaches its target. • Turn the selector button to select another value to be change if necessary or select Exit clock mode key to go back to the help screen. Accessible values for change are: For time: • Hour • Minute • Second For date: • Day • Month • Year

Page 3 of 53

2.

INTRODUCING AQUARIUS

2.1.

General Machine Description The AQUARIUS system is an Automated Fluid Balance Monitor, designed to be use with various extracorporeal treatments in the field of renal replacement therapies or plasma therapies. All therapies must be prescribed by a physician. The AQUARIUS system is divided into two circuits: the extracorporeal (blood) circuit and the substitution or filtrate circuit. Toxic substances are removed by filters and clean blood is returned to the patient. The AQUARIUS system uses two scales to accurately measure and precisely balance filtration and substitution volumes. Anticoagulant may be supplied to the extracorporeal circuit via an anticoagulant pump. The prescribing physician may select continuous or intermittent options. The AQUARIUS protective system is designed as a 2-channel system to protect the patient from foreseeable danger. At the back of the scale system there is mounted a removable hand-crank. This can be used to manually turn the blood pump in case a pump stops. For future applications the machine has two ports on its back side where a datalog box can be connected to realise a data transfer of patient or machine data.

Page 4 of 53

AQUARIUS Front view

I. V. pole

Display Pressure sensor: Prefilter pressure

Postdilution pump

Blood pump Filtrate pump

Predilution pump

Pressure sensor: Filtrate pressure

Return line chamber Degassing chamber (Temp. Sensor)

Filter Anticoagulant pump

Air detector

Pressure sensor: Return pressure

Return line clamp

Pressure sensor: Access pressure

Substitution fluid scale

Filtration fluid scale Wheeled base

Locking wheels Brakes

Figure 1

Page 5 of 53

AQUARIUS Side View (Left)

Blood leak detector Power supply and power switch

Balancing scales

Figure 2

Page 6 of 53

AQUARIUS Side View (Right)

ON/OFF key

Lever for opening heating unit door

Heating unit door

Figure 3

Page 7 of 53

2.2.

Proper Usage / Fields of Application The AQUARIUS system is an Automated Fluid Balance Monitor. It is only designed for use with the treatments described in the following. It may only be operated within the given specifications and limits detailed in the manual.

2.2.1. SCUF (Slow Continuous Ultra-filtration):

During Slow Continuous Ultra-filtration blood is driven through a highly permeable hemofilter via an extracorporeal circuit. SCUF is used primarily to manage fluid overload. The principle of clearance is Convection. Fluid removal is controlled and balanced by the filtrate pump and the scales. The filtrate is not replaced by substitution solution.

Figure 4

Page 8 of 53

2.2.2. CVVH (Continuous Veno-Venous Hemofiltration):

During Continuous Veno-Venous Hemofiltration blood is driven through a highly permeable hemofilter via an extracorporeal circuit.

Sterile, physiological substitution solution is infused into the blood circuit before or after the filter (pre-dilution or post-dilution respectively) and filtrate is removed simultaneously, at an equal or greater rate. CVVH is used to achieve solute removal (small and medium-sized molecules) and fluid balance. The principle of clearance is Convection. The substitution solutions and the filtrate are controlled and balanced by the substitution pumps, filtrate pump, and the scales.

Figure 5

Page 9 of 53

2.2.3. CVVHD (Continuous Veno-Venous Hemodialysis):

During Continuous Veno-Venous Hemodialysis blood is driven through a highly permeable filter via an extracorporeal circuit. Dialysate solution flows through the dialysate compartment of the filter, counter-current to the blood flow. CVVHD is used to achieve solute removal (small molecules) and fluid balance. Filtrate should correspond to the desired net weight loss. No substitution solution is used. The principle of clearance is Diffusion. The dialysate solution and the filtrate are controlled by the substitution pumps (Pre-dilution pump is dialysate pump), filtrate pump and the scales.

Figure 6

Page 10 of 53

2.2.4. CVVHDF (Continuous Veno-Venous hemodiafiltration):

During Continuous Veno-Venous Hemodiafiltration blood is driven through a highly permeable hemofilter via an extracorporeal blood circuit. Sterile, physiological substitution solution is infused into the blood circuit after the filter . Filtrate is removed, simultaneously, at an equal or greater rate. Dialysate solution flows through the dialysate compartment of the filter, counter-current to the blood flow. CVVHDF is used to achieve solute removal (small and medium-sized molecules) and fluid balance. The principles of clearance are Convection and Diffusion. The substitution solutions, dialysate solutions and the filtrate are controlled and balanced by the substitution pumps (Pre-dilution pump is dialysate pump), filtrate pump, and the scales.

Figure 7

Page 11 of 53

2.2.5. TPE (Therapeutic Plasma Exchange):

During TPE blood is driven through a plasma filter via an extracorporeal blood circuit. Plasma is separated from the rest of the blood components and replaced by albumins or FFP (Fresh Frozen Plasma). TPE is used to achieve the removal of toxic substances (large molecules). Fluid balance usually remains unchanged. The plasma exchange is controlled and balanced by the substitution pump, filtrate pump, and the scales.

Figure 8

Page 12 of 53

2.2.6. Hemoperfusion (Blood Detoxification):

During hemoperfusion blood is driven through a hemoperfusion cartridge via an extracorporeal circuit. Hemoperfusion is intended to remove toxic substances from the blood using a hemoperfusion cartridge. The principle of clearance is Adsorption. Fluid removal or substitution solutions are not used.

Figure 9 When using the special tubing sets and filters, cartridges, and solutions be sure to follow the instructions of the respective manufacturers.

Page 13 of 53

2.3.

Labelling The following labels are on the AQUARIUS system: I.

Data plate Date of manufacture

Series No. AQUARIUS Authorized Representative

115/230 V ~

Filtrate scale

4,4/2,2A Edwards Lifesciences LLC Irvine, CA 92614 USA

Edwards Lifesciences Services GmbH D-85716 Unterschleißheim Germany

Type of machine B II.

60/50 Hz

III.

The Filtrate scale is marked yellow.

Manufacturer

Follow instructions

Substitution fluid scale

The substitution fluid scale is marked green.

Yellow

Green

IV.

Fuses

230V:

2 x T 3,15 A

V.

Potential bonding conductor

VII.

Package labeling

115V:

2 x mT 4 A VI.

Protective conductor

Up

Fragile

Keep dry

CE mark

Page 14 of 53

2.4.

Side Effects, Contraindications All generally applicable side effects and contraindications for extracorporeal therapies must be observed. There are no special side effects or contraindications known for the described therapies at present.

2.5.

Safety Instructions and Warnings • •

• • • • • •

•

• • • •

• • • •

During the system test the operator must wait for the generation of the visual and audible alarm signals. If there are errors during the initial functional system test the AQUARIUS system must not be used. Refer to onscreen help and repeat. Notify the technical support if system test continues to fail on the same error. When bypassing one or more of the safety controls the operator is responsible for monitoring the patient. If power is restored after a power outage the operator is responsible for monitoring the patient. When entering the parameters the operator must compare the entered value with the displayed value. The patient parameters must be entered and adjusted in accordance with the instructions of the prescribing physician. Ensure that the patient blood access (usually a central venous catheter) is secured properly. Connecting or disconnecting the patient to or from the AQUARIUS system requires continuous monitoring to prevent air from entering the system (air infusion) or blood from escaping from the system (blood loss). All system connections must be checked at regular intervals. Connecting additional devices may result in exceeding the permissible leakage currents. If the system is used in parallel operations (according to open heart surgery standards), the equipotential bonding conductor must be connected. The AQUARIUS system may only be plugged into a properly installed grounded safety power outlet. Do not operate devices emitting electromagnetic waves near the AQUARIUS system. e.g. cellular phones. The AQUARIUS system must not be operated simultaneously with high frequency surgery systems. The return pressure transducer ensures protection from extracorporeal blood loss. If the pressure drops below the set pressure frame or the absolute pressure limit of 10 mmHg the blood pump stops and the return line clamp closes. Thus, the AQUARIUS system switches immediately to the safety mode. All solutions used must be sterile, of appropriate composition and prescribed by a physician. Use of incorrect solutions can result in patient injury or death. The operator must ensure that the correct substitution solutions and dialysate solutions prescribed by a physician, are used appropriately for all therapies. Solutions of different compositions must not be used simultaneously on the AQUARIUS system. It is recommended that the filters and the AQUARIUS tubing sets be changed after 24 hours of use. The Aqualine tubing set (adult) has been tested under the following high end conditions. This suggests the set may be used for up to 72 hours without adverse effect. Testing conditions: Duration = 72 hrs Pre-filter pressure = 450-500 mmHg Post filter pressure = 300-350 mmHg Blood flow = 450 ml/minute Infusion flow = 10 l/h Temperature = 37°C

Page 15 of 53

• • • • • • • • • • •

2.6.

The AqualineS tubing set (Pediatric) has been tested under the following high end conditions. This suggests the set may be used for up to 72 hours without adverse effect. Testing conditions: Duration = 72 hrs Pre-filter pressure = 450-500 mmHg Post filter pressure = 300-350 mmHg Blood flow = 200 ml/minute Infusion flow = 10 l/h Temperature = 37°C A physician must prescribe the anticoagulant application. Important: The anticoagulant pump is designed for heparin only. Only use anticoagulants that comply with the requirements of national drugs regulations. The operator must make sure that the anticoagulant syringe used has been configured in service mode by a technician. The operator must make sure that the pressure transducers integrated in the tubing sets are clipped on properly to the pressure sensors on the AQUARIUS system. Do NOT remove the pressure transducers during treatment. Negative ultrafiltration: Excessive negative ultrafiltration (a positive balance) may result in patient hazard. The prescribing physician must make this indication. This version of the AQUARIUS system (Platinum) is intended for use in the treatment of adults and children (pediatric). When pediatric treatment is used, the pediatric patient must be physiologically capable to accept the minimum extracorporal blood flow of 10 ml/min. The I.V. pole may only carry a maximum weight of 2.5 kg. If for some reasons the user interface is compromised, the machine will normally stop automatically. In rare instances the machine will however continue even with a Black screen (for example if the back light is broken) In such instances the machine should be stopped manually, and the blood returned to the patient. This is possible by removing the return tube from the venous clamp and manually turning the blood pump with the hand-crank. The hand-crank is located at the back of the scale system.

Operational Sequence (Modes) The operational sequence for the AQUARIUS system is fixed. It is impossible for the operator to accidentally change the sequence.

2.6.1. System test When the power is switched on, the AQUARIUS system is initialised. A system test is performed to verify the system´s main functions. The system test must be performed before the tubing set is attached to the machine. The current software version is displayed during the test.

2.6.2. System test failed

The system test must be repeated if it fails. The onscreen Help function will provide further information to assist with troubleshooting any failure. Follow all suggested corrective actions and retry system test. If alarm messages remain repeatedly, technical service must be informed. The device can be used only if the system test passes.

2.6.3. Preparation

One of the following therapies can be selected in the Preparation mode: SCUF CVVH CVVHD CVVHDF TPE Page 16 of 53

Hemoperfusion Choice of tubing set which will be used (Aqualine for adult and AqualineS for pediatric) has to be performed during Preparation mode. The AQUARIUS system must be prepared for priming. - Refer to section 3.1 for detailed instructions.

2.6.4. Priming

A test compares the choice of tubing set (Adult or Pediatric) and tubing set in-situ at the beginning of priming. In the Priming mode the blood and fluid circuit sections are rinsed and filled: At the end of the priming procedure the user can select Reprime or Next to proceed. - Refer to section 3.2 for detailed instructions.

2.6.5. Clamp & Pressure Test During this test phase the clamp function, the access pressure function, the return pressure function and the pre filter pressure function are tested. This test is only possible if the air detector has determined that the extracorporeal circuit is free from air. An air free circuit is indicated by a steady green light in the clamp key. After a successful test the system goes to Start Connection mode. The operator may select from the following options: Go to programming, Go to recirculation, go to Single connection or go to Double connection - Refer to section 3.2 for detailed instructions.

2.6.6. Recirculation During Recirculation mode the extracorporeal circuit is flushed until the operator is ready to connect the patient to the AQUARIUS. This mode is started and stopped manually by the operator. The patient parameters may be entered during recirculation by selecting the Go to programming option. If the patient parameters are not entered during Recirculation mode they MUST be entered before starting the treatment. Patient parameters must be entered according to the prescription of the responsible physician. To leave Recirculation mode select Go to connection key to connect the patient to the Aquarius or End treatment remove tube system key to proceed the switch off of the device. - Refer to section 3.3 for detailed instructions.

2.6.7. Connecting the Patient

NB: Parameters must be programmed before going to connection mode. During the Single connection mode the operator is asked to connect the access segment of the AQUARIUS tubing set to the access limb (red) of the patient’s catheter. After selecting the Start blood pump key the access and return segments of the AQUARIUS tubing sets are filled with blood, up to the air detector. The blood pump automatically stops when the air detector detects blood.

During the Double connection mode the operator is asked to connect the access segment and the return segment of the AQUARIUS tubing set to the access limb (red) and the return limb (blue) respectively of the patient’s catheter in the same time. After selecting the Start blood pump key the access and return segments of the AQUARIUS tubing sets are filled with blood and it’s switched automatically into Treatment mode when blood is detected by the air detector system. Treatment can then commence. - Refer to section 3.4 for detailed instructions

Page 17 of 53