Aquarius Operators Manual Ver 6.02 Rev 4.0 May 2012

Table of Contents 1

How to use this document (IFU) ... 5 1.1 Organization ... 5 1.2 Related publications ... 5 1.3 Symbols used in this Instructions for Use ... 6 1.4 Abbreviations and terms used in this Instructions for Use ... 9 1.4.1 Organizations ... 9 1.4.2 Units of measure ... 9 1.4.3 Other expressions ... 10

2

Intended purpose... 11 2.1 Intended use ... 11 2.2 Area of Application – Indications... 11 2.3 Contraindications ... 11 2.4 Side effects ... 12 2.5 Warnings ... 12

3

Getting started with the Aquarius system ... 17 3.1 Setting up ... 17 3.2 Installation ... 17 3.3 Equipment: disposables ... 17 3.4 Waste management ... 19 3.5 Materials used ... 20 3.6 Transport and storage ... 20 3.7 Packing... 20 3.8 Service and maintenance ... 20 3.9 Set time and date ... 21

4

Introducing the Aquarius system ... 23 4.1 General machine description ... 23 4.2 Proper usage / Treatment procedures... 27 4.2.1 SCUF (Slow Continuous Ultra-filtration): ... 27 4.2.2 CVVH (Continuous Veno-Venous Hemofiltration): ... 27 4.2.3 CVVHD (Continuous Veno-Venous Hemodialysis): ... 28 4.2.4 CVVHDF (Continuous Veno-Venous Hemodiafiltration):... 29 4.2.5 TPE (Therapeutic Plasma Exchange): ... 29 4.2.6 Hemoperfusion (Blood Detoxification): ... 30 4.3 Labeling... 31 4.3.1 Data Plate... 31 4.3.2 Filtrate scale ... 31 4.3.3 Substitution fluid scale ... 31 4.3.4 Fuses... 32 4.3.5 Potential equalization conductor... 32 4.3.6 Protective earth conductor ... 32

IFU Aquarius SW 6.02, Rev.4.0 (09/2012)

Page 1 of 142

4.3.7 4.3.8 4.3.9

Package labeling ... 32 Aqualine tubing set color code ... 32 Front overlay panel... 33

4.4 Operational sequence (modes) ... 34 4.4.1 System test... 34 4.4.2 System test failed ... 34 4.4.3 Preparation ... 34 4.4.4 Priming ... 34 4.4.5 Clamp and Pressure Test ... 34 4.4.6 Recirculation... 35 4.4.7 Connecting the Patient ... 35 4.4.8 Treatment ... 35 4.4.9 Disconnecting the Patient... 35 4.4.10 Terminating the Treatment ... 35 4.5 Operating concept ... 36 4.5.1 Operation status display ... 37 4.5.2 Mute function key ... 37 4.5.3 Clamp function key ... 37 4.5.4 Main Selector button ... 37 4.5.5 Balance Start/Stop function key ... 38 4.5.6 Blood pump function key ... 38 4.6 Safety concept ... 38 5

Performing a treatment with the Aquarius system ... 41 5.1 Preparing the Aquarius system ... 41 5.1.1 Switch ON ... 41 5.1.2 Selecting a therapy... 42 5.1.3 Preparation Mode - Selecting the tubing set ... 43 5.1.4 Preparation Mode - Installing the tubing set and empty bags... 45 5.1.5 Preparation Mode - Installing the filter and bags, and connecting the lines ... 49 5.1.6 Preparation Mode - Preparing the anticoagulant ... 54 5.2 Automatic degassing unit priming and use ... 57 5.2.1 Aqualine Tubing Installation: ... 58 5.2.2 Priming: ... 60 5.2.3 Operational Mode: ... 60 5.2.4 ADU Alarms and Controls: ... 61 5.3 Priming mode - Priming the Aquarius system ... 62 5.3.1 Priming Mode - Wrong tubing set selected or clamp closed message ... 65 5.3.2 Priming Mode - Reprime mode... 65 5.4 Clamp and pressure test... 67 5.5 Recirculation mode - Recirculating saline solution ... 70 5.6 Programming - Entering Patient Parameters ... 72 5.7 Start Connection - Connecting the Patient ... 73 5.7.1 Single connection ... 74 5.7.2 Double connection... 77 5.8 Treatment mode - Description of functions throughout treatment ... 79 5.8.1 History ... 80 5.8.2 Recirculation... 82 5.8.3 End Treatment... 85 5.8.4 Change syringe ... 85 5.8.5 Therapy Change... 87 5.8.6 More Screen ... 88

IFU Aquarius SW 6.02, Rev.4.0 (09/2012)

Page 2 of 142

5.8.7 5.8.8

Therapy Target Achieved ... 91 Treatment termination due to running time... 92

5.9 Access disconnection and return disconnection - Disconnecting the patient... 93 5.10 Safe removal of the Aqualine tubing set ... 96 5.10.1 Instructions to decrease pressure level ... 97 5.11 Aquarius system therapy modes ... 100 5.11.1 SCUF (Slow Continuous UltraFiltration) ... 101 5.11.2 CVVH (Continuous Veno-Venous Hemofiltration) ... 102 5.11.3 CVVH Pre-dilution ... 103 5.11.4 CVVH Post-dilution... 103 5.11.5 CVVHD (Continuous Veno-Venous Hemodialysis) ... 105 5.11.6 CVVHDF (Continuous Veno-Venous Hemodiafiltration)... 106 5.11.7 TPE (Therapeutic Plasma Exchange) ... 108 5.11.8 Hemoperfusion ... 109 6

Aquarius system alarms and messages... 111 6.1 Description of alarm operation ... 111 6.1.1 Fluid (filtrate, substitution, dialysate) circuit alarms ... 112 6.1.2 Aquarius Solution Heater ... 112 6.1.3 Total Fluid Loss (TFL) management ... 112 6.2 Alarms, messages, system errors and removal options ... 114 6.2.1 Alarms ... 114 6.2.2 Messages ... 120 6.2.3 System Errors... 125

7

Aquarius system technical data ... 131 7.1 Dimensions and weight ... 131 7.2 Electrical power supply ... 131 7.3 Electrical safety ... 131 7.4 Power outage operation... 132 7.5 Technical data of individual components and essential performance data ... 132 7.6 Heater performance data ... 135

8

Guidance and manufacturer declaration – Electromagnetic emissions ... 137 8.1 Safety rules – Electromagnetic compatibility ... 137 8.2 Guidance and manufacturer declaration – Electromagnetic emissions and immunity ... 137

9

Aquarius system cleaning and disinfection ... 141 9.1 Cleaning ... 141 9.2 Disinfection ... 141

10

Aquarius system warranty and liability ... 141

11

References ... 142

IFU Aquarius SW 6.02, Rev.4.0 (09/2012)

Page 3 of 142

IFU Aquarius SW 6.02, Rev.4.0 (09/2012)

Page 4 of 142

1

How to use this document (IFU) The Aquarius system must only be operated in accordance with the procedures contained in this Instructions for Use, by trained and qualified personnel. The use of operating procedures, maintenance procedures or accessory devices other than those published or recommended by the manufacturer can result in patient injury or death.

1.1

Organization The material in this Instructions for Use is organized in 11 sections. Section Title

Content

1-How to use this Instructions for Use

This section describes the organization and content of this document.

2-Intended purpose

This section describes the intended purpose, indications, contraindication, and general warnings of Aquarius system.

3-Getting started with the Aquarius system

This section provides the precautions and instructions needed to set up the Aquarius system.

4-Introducing the Aquarius system

This section describes the Aquarius system.

5-Performing a treatment with the Aquarius system 6-Aquarius system alarms and messages

1.2

This section describes the steps necessary to turn on the Aquarius system, prime the system, connect to a patient, perform a treatment and end a treatment. The alarms and messages generated by the Aquarius system are described. For each alarm, potential causes and corrective actions are listed.

7-Aquarius system technical data

Lists the technical specifications of the Aquarius system.

8-Guidance and manufacturer declarationElectromagnetic emissions

Describes compliance with EMC norms.

9-Aquarius system cleaning and disinfection

Cleaning and disinfection instructions are listed here for the Aquarius system.

10-Aquarius system warranty and liability

Information related to warranty and liabilities are described in this section.

11-References

References used to generate this document

Related publications Aquarius system Service Manual: Information on the configuration of the instrument, testing and calibration of all systems (including safety systems), required periodic maintenance, necessary diagrams and replacement parts are all contained in the Service Manual.

To determine if a more recent version of the Aquarius system Instructions for Use is available, contact your service representative.

IFU Aquarius SW 6.02, Rev.4.0 (09/2012)

Page 5 of 142

1.3

Symbols used in this Instructions for Use When step-by-step instructions are being given, the left column on the page is used for the step number. Otherwise, you may see one of the following symbols. This symbol indicates that the text to the right is necessary information to fully understand the procedures that follow.

This symbol indicates supplementary information.

This symbol draws attention to a “Caution”. “Cautions” are used to warn 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. This symbol is used to draw your attention to a “Warning”. “Warnings” are used to alert the reader about a situation which, if not avoided, could result in death or serious injury.

This symbol is used in graphics to call your attention to the part of the graphic referred to in the accompanying text. If it includes a number, the number refers to the step or sub-step number in the text. Symbols used on/in the Aquarius system Mute Reset Air Detector / Return Clamp Balance On/Off Blood Pump On/Off Filtrate Scale (Yellow Dot) Substitution Scale (Green Dot)



Alternating current Potential equalization conductor Protective earth conductor Degree of protection against shock: Type B.

Year of manufacture

IFU Aquarius SW 6.02, Rev.4.0 (09/2012)

Page 6 of 142

Manufacturer

Separate collection for electrical and electronic equipment Product conforms to a particular directive of the European Union (European Medical Device Directive 93/42/EEC) 0123 is the identification number of the Notified Body TUV SUD Product Service Non-condensing

Humidity range for transportation and storage of product (from 30 to 80%)

Temperature range for transportation and storage (from -5 to 45°C)

Pressure range for transportation and storage (from 50 to 105 kPa)

IPX1

Degree of case waterproofing: protection against vertically falling water drops

Follow instructions for use Indicates compliance with both Canadian and U.S. requirements with respect to electrical shock, fire and mechanical hazards in accordance with UL 60601-1:2003 and CAN/CSA-C22.2 No. 601.1-M90. Interference may occur in the vicinity of equipment marked with this symbol

Up (Package labeling)

Fragile (Package labeling)

Keep dry (Package labeling)

Do not remove from pallet

Installation by authorized technician before use

Pollution control symbol (China) IFU Aquarius SW 6.02, Rev.4.0 (09/2012)

Page 7 of 142

Hemofiltration system

Generic device name according Global Medical Device Nomenclature (GMDN)

IFU Aquarius SW 6.02, Rev.4.0 (09/2012)

Page 8 of 142

1.4

Abbreviations and terms used in this Instructions for Use

1.4.1

Organizations

1.4.2

Abbreviation

Definition

AAMI

Association for the Advancement of Medical Instrumentation

CSA

Canadian Standards Association. This designation indicates that a product conforms to the standards of the Canadian Standards Association.

TÜV

Technische Überwachungs-Vereine (Testing laboratories)

UL

Underwriters‟ Laboratories. This designation indicates that a product conforms to the standards set by Underwriters‟ Laboratories.

Units of measure Abbreviation

Definition

A

Ampere (unit of electric current)

°C

Degrees Celsius

cm

Centimeters

°F

Degrees Fahrenheit

h

Hour

Hz

Hertz (unit of frequency)

kg

Kilogram

l

Liter

min

Minute

ml/h

Milliliters per hour

ml/min

Milliliters per minute

mmHg

Millimeter of mercury (unit of pressure)

s

Second

V

Volt

IFU Aquarius SW 6.02, Rev.4.0 (09/2012)

Page 9 of 142

1.4.3

Other expressions Expression

Definition

Access

The tubing line supplying blood from the patient.

ADU

Automatic Degassing Unit

Balance pumps

Pre- and post-dilution pumps, Filtrate pump

BLD

Blood Leak Detector Conformité Européenne. This designation indicates that a product conforms to a particular directive of the European Union.

CE CRRT

Continuous renal replacement therapies

CVVH

Continuous veno venous hemofiltration

CVVHD

Continuous veno venous hemodialysis

CVVHDF

Continuous veno venous hemodiafiltration

EP

European Pharmacopoeia

FFP

Fresh Frozen Plasma

Fluid loss total

Amount of fluid removed from the patient

Hemofilter

Filter used in hemofiltration for its practical impermeability to albumin.

Hemoperfusion (HP)

Blood filtration using adsorption

Hypervolemia

Name of the medical state caused by excessive fluid in the blood

Hypovolemia

Name of the medical state caused by a decrease in blood plasma

Important

Highlights specific actions or steps to be followed in order to avoid defeating equipment functionality or cause product damage

IFU

Instructions for Use (this document)

I.V.

Intravenous

KUf

Ultrafiltration coefficient

Note

Instructs in specific terms where a general statement about an action or a series of actions may be vague or confusing and clarifies other issues needing the reader's attention

Operator

Trained medical personnel using Aquarius system

PD

Pressure drop

Reminder

Specifies that the given information has been previously mentioned

Return

The tubing line returning blood to the patient

SCUF

Slow continuous ultrafiltration

TMP

Transmembrane pressure

TPE

Therapeutic plasma exchange

Turnover rate UF IFU Aquarius SW 6.02, Rev.4.0 (09/2012)

The sum of the programmed Loss rate, the Pre-dilution and the Post-dilution substitution fluid rates. Ultrafiltration Page 10 of 142

2

Intended purpose

2.1

Intended use

The Aquarius system is indicated for continuous renal replacement therapies (CRRT) in patients with acute renal failure or fluid overload. The Aquarius system may also be used in Therapeutic Plasma Exchange (TPE) and Hemoperfusion therapies.

2.2

Area of Application – Indications

The Aquarius system controls and monitors the extracorporeal blood circuit and the fluid balance circuit. The fluid balance circuit is defined as a filtrate/substitution system in hemofiltration, a filtrate/dialysate system in hemodialysis, a filtrate/dialysate-substitution system in hemodiafiltration, a plasma/substitution system in therapeutic plasma exchange, and a filtrate system only in slow continuous ultrafiltration. The fluid balance circuit is inactive in hemoperfusion. The fluid balance is controlled by pumps and scales. Toxins are removed from the blood and the blood composition is corrected by means of filters and solutions, using filtration and/or adsorption in the extracorporeal circuit. The blood is then returned to the patient. Details of treatment procedures are described in section 4.2 Proper usage /Treatment procedures of the present Instructions For Use. All therapies using the Aquarius system must be prescribed by and performed under the responsibility of a physician who is familiar and well informed about the therapies.The prescribed treatment must be performed by trained medical personnel in medical facilities. The Aquarius system is intended to enable anticoagulation with heparin by using the integrated heparin syringe pump in all treatment procedures. The Aquarius system heparin syringe pump is intended to deliver heparin into the extracorporeal circuit. The use of the Aquarius system is limited to patients weighing a minimum of 20 kg and the extracorporeal blood volume, including tubing set and filter (in ml), should not exceed 10% of the patient‟s blood volume.

2.3

Contraindications

No contraindications associated specifically to the Aquarius system are currently known when it is used according to Indications. General All generally applicable side effects and contraindications for extracorporeal therapies must be observed. An extracorporeal treatment procedure with the Aquarius system should be performed after careful consideration of the risks and benefits by the responsible physician, in patients     

incapable to tolerate an extracorporeal treatment procedure because of their age and their physical development or their clinical condition, with known hypersensitivity to the substances used in the extracorporeal circuit, with severe anemia, with hemorrhagic diathesis (bleeding tendencies), with coagulopathy (blood clotting disorders).

Disposables The contraindications for the disposable medical devices / medicinal product used as accessories with the Aquarius system must be considered. It is essential to observe the instructions for use supplied with the medical device / medicinal product, as these contain updated information on areas of use, side effects, and contraindications for the respective disposable product.

IFU Aquarius SW 6.02, Rev.4.0 (09/2012)

Page 11 of 142

2.4

Side effects

No side effects associated specifically with the Aquarius system are currently known. General side effect associated to extracorporal procedures are the following: Stress from extracorporeal circuit Extracorporeal treatment procedures are always linked to individual stress for each patient, possibly leading to non-specific side effects, such as tiredness, nausea, sweating, dizziness, headache, reduction in blood pressure, change in pulse rate, arrhythmia, shock, chills, fever, or bleeding. Vascular access Extracorporeal treatment procedures require vascular access mainly created by vein puncture. Therefore, there is a possibility that the vein puncture is performed incorrectly, which may lead to hematoma, thrombosis, nerve injury, vasovegal reaction and/or inflammation of the vascular area. Blood loss Extracorporeal treatment procedures may result in blood loss caused by circuit leaks or clotting. Circulatory complications Extracorporeal treatment procedures may result in circulatory complications, such as hypertension and hypotension from temporary fluid displacement within or from the extracorporeal circuit Anaphylactic reaction Extracorporeal treatment procedures may result in anaphylactic reaction from intolerance to the accessories, exchange fluid, dialysate solution, or anticoagulants Heparin anticoagulation The heparin administration can lead to side effects. Bleeding, heparin induced thrombocytopenia and other general side effects associate with Heparin must be considered.

2.5

Warnings Read all warnings, precautions and instructions carefully before using the Aquarius system. This summary does not contain all the safety statements in this Instructions for Use. Other cautions and warnings exist within this Instructions for Use.

The following warnings must be observed in order to avoid possible dangers associated with a high risk of death or severe injury for patients, operators, or third parties. Installation and connection, moving of the device The installation of the Aquarius system at the place of operation according to the technical service manual must be performed by trained personnel authorized by the manufacturer. 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. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. When using a device of safety class I, like the Aquarius system, the quality of the protective conductor of the installation is important. It should be noted that it is officially specified by the authorities in many countries. The Aquarius system may only be operated with connection of the potential equalization to insure electromagnetic immunity. Release the brake of both wheels before move the device! Move the device carefully over steps or crevice. No modification of this equipment is allowed. Do not modify this equipment without authorization of the manufacturer. IFU Aquarius SW 6.02, Rev.4.0 (09/2012)

Page 12 of 142

If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of the equipment.

Treatment environment Do not operate devices emitting electromagnetic energy near the Aquarius system. E.g. cellular phones. Do not operate the Aquarius system close to areas where explosive gasses or flammable anesthetics are or have been used. The Aquarius system must not be operated simultaneously with high frequency surgical systems.

Accessories, disposable products, drugs, and replacement fluids Solutions of different compositions must not be used simultaneously on the Aquarius system. 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. If a commercially available replacement solution is used, it must be labeled as intended for intravenous injection. The operator must ensure that the correct substitution solutions and dialysate solutions prescribed by a physician are used appropriately for all therapies. Only use heparin that complies with the requirements of national drug regulations and observe the information contained in its package insert. It is recommended that the filters and the Aqualine tubing sets be changed after 24 hours of use. The Aqualine tubing set (adult) has been tested under the following high end conditions without adverse effect: Duration = 72 h Pre-filter pressure = 450-500 mmHg Post filter pressure = 300-350 mmHg Blood flow = 450 ml/min Infusion flow = 10 l/h Temperature = 37°C The Aqualine „S‟ tubing set (pediatric) has been tested under the following high end conditions without adverse effect: Duration = 72 h Pre-filter pressure = 450-500 mmHg Post filter pressure = 300-350 mmHg Blood flow = 200 ml/min Infusion flow = 10 l/h Temperature = 37°C Operation and use Only staff trained by the manufacturer shall operate the Aquarius system. During the system test, the operator must wait for the visual and audible alarm signals to be generated. If there are errors during the initial functional system test the Aquarius system must not be used. Refer to onscreen help and repeat. Notify technical support if the system test continues to fail on the same error.

IFU Aquarius SW 6.02, Rev.4.0 (09/2012)

Page 13 of 142

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’s blood access (usually a central venous catheter) is secured properly. Connecting or disconnecting the patient to or from the Aquarius system requires aseptic technique and 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. All blood and fluid paths are sterile and non-pyrogenic. Always follow hospital policy for standard precautions. Gloves, mask and a face shield should be worn when connecting or disconnecting blood lines from patients and removing lines from the Aquarius system. In case of negative return pressure, air may enter into the extracorporeal circuit downstream the air detector and not be detected. The operator must make sure that the heparin syringe used has been configured in service mode by a technician. Use only Luer-lock syringes designed for syringe pumps (ISO 7886-2). A physician must prescribe the anticoagulation application. When “No anticoagulant” is selected, constantly monitor the TMP and pressure drop values to reduce or avoid the risk of clotting of the extracorporeal circuit (filter and lines). The operator must make sure that the pressure domes integrated in the tubing sets are clipped on properly to the pressure sensors on the Aquarius system. Do NOT remove the pressure domes during treatment. DO NOT move the Aquarius system during treatment: movement of the device while the Balance system is active can cause false balance alarms and may lead to undesired automatic fluid compensation. The Aquarius system must be placed on a horizontal plane during its normal use. Angle discrepancies from the horizontal plane larger than 10° may cause device instability and inaccurate functioning. Before removing the Aqualine tubing set or disconnecting domes after ending treatment, make sure that pressure level inside tubes are below 400 mmHg. The end treatment screen displays all four pressures from the system. Use a syringe or Aquasafe bag to decrease the pressure level before removing a dome from a pressure sensor. When domes are removed from pressure sensors in over pressure conditions, there is high risk of burst and leakage of dome membranes. Negative ultrafiltration: Excessive negative ultrafiltration (a positive balance) may result in patient hazard. The prescribing physician must make this indication. When pediatric treatment is used, the patient must be physiologically capable to accept the minimum extra-corporeal blood flow of 10 ml/min. The I.V. pole may only carry a maximum weight of 2.5 kg. The Aquarius system is not intended to be a substitute for monitoring the patient's condition. Treatment data sent by the Aquarius system from the optical ports are intended for documentation purpose only. They are NOT intended for diagnostic purposes.

IFU Aquarius SW 6.02, Rev.4.0 (09/2012)

Page 14 of 142

All connecting points on the system must be regularly and carefully checked to protect against blood loss. Particular care should be taken to ensure that the venous access site catheter/needle is secure and does not slip out from the vessel. Complete monitoring of the extracorporeal system to avoid blood losses is practically impossible with the current state of technology. The Aquarius system monitors the venous pressure in order to detect disconnections in the extracorporeal system. The system triggers an alarm if it detects a pressure drop of 30 mmHg below the working value measured 1 min after the start of the blood pump or a measured pressure lower than +20 mmHg. Ensure that the filtrate bags and substitution bags do not touch the cart frame. Ensure that the tubing lines are not supported by and are not resting on the cart frame. Do not touch the filtrate or substitution solution bags while the balance system is active. Observe this warning to avoid patient fluid balance errors. Fluid leaks lead to a patient fluid balance error and can harm the patient seriously. Ensure that all connectors are closed properly to prevent any potential fluid leak. Ensure that unused tubing lines of the 4 way connectors are properly clamped. Alarm and system If for some reason the operator interface is compromised, the machine will normally stop automatically. In rare instances, the machine will continue 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 line from the automatic clamp and manually turning the blood pump with the hand-crank. The hand-crank is located at the back of the scale system. Be careful during manual blood return to patient, as the return line is not automatically clamped if air is present. 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. Interference to the Electrocardiograph (ECG) monitor Electrically isolated peristaltic pumps such as those used on the Aquarius system can produce electrostatic charges in the disposable set that are not hazardous to the patient, but can appear as an artifact on cardiac monitors. When starting treatment, observe the cardiac monitor before and after starting the blood pump to verify that the artifact is not present.

IFU Aquarius SW 6.02, Rev.4.0 (09/2012)

Page 15 of 142

IFU Aquarius SW 6.02, Rev.4.0 (09/2012)

Page 16 of 142

3

Getting started with the Aquarius system

3.1

Setting up Personnel authorized 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.

3.2

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 should only be set up and installed by qualified staff authorized by the manufacturer. Only authorized staff together with the prescribing physician should do basic modifications of particular settings that do not change the safety concept of the Aquarius system.

3.3

Equipment: disposables The Aquarius system is designed to operate exclusively with the standard disposables intended for the indicated treatments. Follow the instructions for use provided by the manufacturer.

Use only the tubing sets stated below to ensure the proper operation of the Aquarius system.

Item

Description

Tubing set

REF: Aqualine tubing Adult line set Extracorporeal volume (Blood circuit) = 112 ml* Tubing set REF: Aqualine „S‟ tubing Pediatric line set Extracorporeal volume (Blood circuit)= 65 ml* *These values assume that the drip chamber is full.

IFU Aquarius SW 6.02, Rev.4.0 (09/2012)

Manufacturer Haemotronic Haemotronic

Page 17 of 142

The Aquarius system level test was performed with the following disposables: Item

Description

Manufacturer

Tubing set

REF: Aqualine tubing Haemotronic Adult line set Extracorporeal volume (Blood circuit) = 100 ml* Tubing set REF: Aqualine „S‟ tubing Haemotronic Pediatric line set Extracorporeal volume (Blood circuit) = 61 ml* Hemofilter REF: HF03, HF07+, HF12, HF19 Bellco Aquamax hemofilters Plasma filter REF: MPS05 Bellco Plasma filter 0.5 m2 Solution Accusol 35 Baxter Replacement solution for CRRT, 5L Disposable REF: Aquasafe bags Haemotronic For use with Aqualine and Aqualine „S‟ tubing sets, prior to their removal from the machine, to decrease internal pressure Disposable REF: Aquaspike 2 manifolds Haemotronic Manifolds for connecting up to four solution or waste bags Disposable REF: B3052 Haemotronic Waste bag Syringe** REF: BD Plastipak 50ml Becton Dickinson Syringe for Heparin pump Syringe** REF: Fresenius Injektomat Syringe 50ml Fresenius Syringe for Heparin pump Syringe** REF: Original Braun Perfusor Syringe 50ml BBraun Syringe for Heparin pump *These values assume that the drip chamber is 2/3 full, which is the normal situation during treatment. ** Important: Use only with max. 50ml, even if the max. volume of the syringe is 60ml 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 lock connectors. 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. Always ensure that the appropriate filter is used for the intended therapy: o Hemofilter for SCUF, CVVH, CVVHD, CVVHDF o Plasma filter for TPE o Hemoperfusion cartridge for Hemoperfusion The use of an inappropriate filter for a selected therapy can result in a patient injury or death. Risk of hemolysis. For plasma filters do not exceed the transmembrane pressure indicated in the Instructions For Use of the filter. This alarm limit is preset to 100mmHg in TPE therapy mode. Replacement solutions and dialysate have to be sterile and must meet European Pharmacopoeia requirements. Use only 4.5 l or 5 l bags with female Luer lock connectors or a sterile adapter to male Luer lock connectors. The prescribing physician must define concentration and composition requirements. IFU Aquarius SW 6.02, Rev.4.0 (09/2012)

Page 18 of 142

Never use solutions of different compositions simultaneously with the Aquarius system! To protect patients from cross-infection, only tubing sets equipped with pressure measurement leads with hydrophobic 0.2 µm filters that exclude bacteria may be used. To avoid false “No bag“ alarms, do not use empty bags with a weight less than 80g. For information on the disposables supplied and recommended for the Aquarius system, please contact your Official Representative or call Customer Service.

3.4

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 bio-hazardous 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 your local Technical Service Representative.

Part name

Toxic or Hazardous Substances and Elements Cadmium Hexavalent Polybrominated Polybrominated (Cd) Chromium biphenyls (PBB) diphenyl ethers (Cr (VI)) (PBDE) Housing X ○ ○ ○ ○ ○ TFT-Display ○ X X ○ ○ ○ Accumulator X ○ ○ ○ ○ ○ Electronics X X X ○ ○ ○ Motors ○ ○ ○ ○ ○ ○ Magnetic Clamp ○ ○ ○ ○ ○ ○ Front Panel ○ ○ ○ ○ ○ ○ Wheels ○ ○ ○ ○ ○ ○ Cabling ○ ○ ○ ○ ○ X Varnishing ○ ○ ○ ○ ○ ○ ○: Indicates that this toxic or hazardous substance contained in all of the homogeneous materials for this part is below the limit requirement in SJ/T11363-2006 ( Standard of the Electronics Industry of the People‟s Republic of China) X: Indicates that this toxic or hazardous substance contained in at least one of the homogeneous materials used for this part is above the limit requirements in SJ/T11363-2006. Lead (Pb)

Mercury (Hg)

The environmental protection period for the device is specified in the pollution control symbol displayed above. The product should be stored and operated in accordance with the Instructions for Use, with particular regard to the environmental conditions described for use of the device.

IFU Aquarius SW 6.02, Rev.4.0 (09/2012)

Page 19 of 142