Aquarius Automatic Degassing Unit Operators Manual Addendum Rev E Oct 2005

INTRODUCTION: This Operating Manual Addendum provides instructions necessary for the proper operation of the Aquarius™ System upgraded with the Automatic Degassing Unit (ADU). It is not a guide to the administration of the therapies provided. Please refer to the main Operating Manuals for machines without ADU upgrade and for all other instructions for use.

GENERAL DESCRIPTION OF ADU The Aquarius automatic degassing unit sets the level in the degassing chamber automatically (± 1cm around the light beam). Gas inside the substitution chamber, caused by degassing from substitution/dialysate fluid, is removed by a small pump inside the ADU box (placed inside the Aquarius). Two hydrophobic filters prevent the Aquarius degassing unit contaminating the substitution fluid. One hydrophobic filter is located outside, on the degassing tubing. A second filter is located inside the Aquarius before the pressure unit. The level is controlled by an infra-red light beam and pressure. The Aquarius automatic degassing unit is a microprocessor-controlled system. The degassing unit works independently from the Aquarius, except for the power supply. Therefore, the system works independently from the software version in use.

AQUALINE CHANGES DESCRIPTION Aqualine and Aqualine(S) tubing sets have been modified for ADU function. However, these modified tubing sets still enable use on Aquarius machines without the ADU upgrade. IN and OUT tubes inside the chamber have been modified for a better degassing of fluid inside the chamber. An additional tubing segment is located on top of the degassing chamber, with a Clamp and a hydrophobic filter with female luer-lock connector for ADU pressure sensor connection. To Substitution and/or dialysate pumps

FIGURE 1

Female Luer-lock connector to ADU Pressure sensor Hydrophobic filter Degassing chamber

Clamps Line for manual priming (with syringe) Fluid IN

Fluid OUT Heater coil

From Substitution/dialysate bags

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Post-dilution line

Heparin line Substitution Pre-dilution port

Filtration bag

Pre-filter pressure dome

Pre-dilution or dialysate line

Filtration BLD chamber

Filtration line

Automatic degassing chamber system line Return pressure dome

Access line

Air bubble trap

Filtrate pressure dome

Access pressure dome

Heater coil Degassing chamber Substitution or dialysate line

Empty priming collect bag

Return line

FIGURE 2

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AQUALINE INSTALLATION: Aqualine kit installation is identical to non-modified machines (refer to the main Operating Manual). Only installation of degassing chamber change and steps are described below:

Vertical position

Step1: Place ADU fixation clip into its vertical position, to allow placement of degassing chamber into its housing holder.

Switch OFF

Step2: Place degassing chamber inside the ADU holder and make sure that holder switch is pressed ON by the chamber.

Switch ON

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Step3: Place the fixation clip to its horizontal position in order to fix the degassing chamber into its functional position.

Horizontal position

Warning: If the fixation clip is not properly closed, the alarm Degassing chamber missing appears at the end of priming.

From Heater Small line with clamp Inserted into fixation clip housing When degassing chamber has been installed, it should be positioned as shown.

To ADU pressure sensor To green pumps

Step 4: Connect the luer-lock hydrophobic filter from ADU pressure line to the ADU pressure sensor connection. DO NOT FORGET TO CONNECT DEGASSING LINE TO PRESSURE SENSOR

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AUTOMATIC DEGASSING UNIT DESCRIPTION ADU HOUSING

Automatic Degassing Unit

Pressure Sensor

Light beam Temperature sensors

Indication light Reset key

Control switch

ADU FIXATION CLIP

Horizontal position sensor

Vertical fixation system

Spring

The light beam detects the fluid level inside the chamber. The pressure sensor is used to control the degassing process. The reset key allows reset in case of alarm. A double colour diode on the reset key gives information regarding degassing process status. Page 6 of 13

ADU SELFTEST WARNING ! After switching on of the Aquarius device, the user is to verify the reset key diode is yellow with an audible signal. The LED then flashes with a green light which indicates that the self test has passed.

PRIMING The Aquarius automatic degassing unit starts working during priming mode. When the ADU pressure sensor detects less than -30 mmHg (Post-dilution pump is running) the ADU will automatically prime the degassing chamber (green diode switches from flashing to constant), AFTER 10 seconds FOR 10 seconds. If the infra red sensor does not detect water after the initial prime, the pump will start again AFTER 2 minutes. For the second prime, the motor stops priming when liquid is detected at the infra-red sensor (second priming can not run more than 25 seconds). If degassing line (with hydrophobic filter) is not connected to the pressure sensor, ADU status stays OFF (Stand-by mode, green diode flashing).

L

At the end of the priming mode the user has to check visually the fluid level inside the degassing chamber!

FUNCTIONAL MODE During functional mode, if the light beams don’t detect fluid, the ADU will pump for a maximum of 3.5 seconds. If fluid is then detected it will pump from an additional 2 to a maximum of 3.5 seconds. If fluid is not detected after 3.5 seconds of pumping, the pump will start again after 10 seconds. Waiting time during 2 consecutive pumping is always a minimum of 10 seconds. If fluid is detected, pump will not start.

ALARMS AND CONTROLS Four different operation modes are indicated by the LEDs. 1. 2. 3. 4.

ADU Self test: ADU Self test failed: ADU Ready: ADU Working mode:

ADU Red and Green LEDs are on. ADU Red Led is flashing. Additional audible alarm. ADU Green LED is flashing. ADU Green LED is permanently lit.

The Aquarius degassing unit generates audible and visible alarms (ADU Red LED lit permanently) under the following conditions: 1.

If the motor works for more than 25 sec. without detecting a filled chamber.

2.

If the hydrophobic filter is blocked (measured pressure less than –300 mmHg).

3.

If the system detects a positive pressure higher than +30 mmHg.

4.

If self test fails.

In case of an alarm, eliminate the alarm cause. If the Aquarius degassing unit detects “normal conditions” (no blocked hydrophobic filter and a set level) the alarm is disabled. If the alarm is still active, the reset button has to be pressed. The Aquarius Degassing unit resets automatically after 24 hours. If the hydrophobic filter is disconnected from pressure sensor (Pressure>-30 mmHg) or if there is a leakage on the line, the pressure changes to 0 mmHg and the ADU changes to stand-by mode (green flashing diode)

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During treatment the ADU system will keep the fluid level constant inside the degassing chamber (± 1cm around the light beam) . If the fixation clip is not placed in its horizontal functional position, Insert degassing chamber or Degassing chamber missing alarm occurs at the end of priming and during treatment mode.

TECHNICAL SPECIFICATION COMPONENTS Infra-red diodes

SPECIFICATIONS 50 Hz +/- 10%

Pressure working range (alarm range)

-300 mmHg to + 30 mmHg

Power supply

From Aquarius : + 24 V

Audible Alarm

1 Hz +/- 0.5 Hz

Constant level

± 1cm around the light beam

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Guidance and manufacturer declaration- Electromagnetic emission 1. Safety rules – Electromagnetic Compatibility

Medical electrical equipment needs special precautions regarding electromagnetic compatibility. In respect of this, the installation and operating notes must be kept in accordance to the guidance and manufacturer declarations.

The emission and the immunity characteristic of the device is in accordance to the requirements for not lifesupporting devices in a typical clinical environment under consideration of normal use.

Special prudence is required by the use of portable and mobile RF communication equipment such as cellular phones, mobiles, laptops with W-LAN / Bluetooth and other similarly equipment.

The device should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the device should be observed to verify normal operation the configuration in which it will be used.

unauthorized variations, modifications, reparations, services and the use of unregistered equipment may result in increased emissions and/or decreased immunity of the device, therefore this is not permitted.

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2. Guidance and Manufacturer declaration – Electromagnetic emissions and immunity Guidance and manufacturer declaration- Electromagnetic emission The Aquarius is designed for use in the electromagnetic environments specified below. The user of the Aquarius is to ensure, that the device is used in such an environment. Radiation measurement Conformity Electromagnetic area RF-Emission (CISPR 11) Group 1 The Aquarius uses RF-energy only for its internal function. Therefore the RF-emissions are very low. It is unlikely, that electronic systems in the area of the Aquarius are disturbed. RF-Emission (CISPR 11) Class B The Aquarius is suitable for use in all establishments, including domestic establishments and those directly Harmonic current emissions Class A connected to the public low-voltage power supply network (IEC 61000-3-2) that supplies buildings used for domestic purposes. Voltage fluctuation and flicker Confirms (IEC 61000-3-3) Table I

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Guidance and manufacturer declaration- EMC Immunity Guidance and manufacturer declaration- EMC Immunity The Aquarius is designed for use in the electromagnetic environments specified below. The user of the Aquarius has to ensure, that the device is used in such an environment. Immunity test

IEC 60601-test level

Compliance-Level

Electromagnetic environment – Guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %

EMS-Electrical static discharge (IEC 61000-4-2)

± 6 kV direct-discharge

± 6 kV direct-discharge

± 8 kV air-discharge

± 8 kV air-discharge

EMS-Bursts (IEC 61000-4-4)

± 2 kV power supply input lines and PE

± 2 kV power supply input lines

± 1 kV for input and output lines

n.a.

EMS-Surges (IEC 61000-4-5) ± 1 kV differential mode

± 1 kV differential mode

± 2 kV common mode

± 2 kV common mode

< 5% UT

< 5% UT

EMS-Voltage dips, short interruptions and voltage variations on power supply input lines (IEC 61000-4-11)

(> 95% dip in UT for ½ (> 95% dip in UT for ½ cycles) cycles) 40% UT

40% UT

(60% dip in UT for 5 cycles)

(60% dip in UT for 5 cycles)

70% UT

70% UT

(30% dip in UT for 25 cycles)

(30% dip in UT for 25 cycles)

< 5% UT

< 5% UT

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the Aquarius requires continued operation during power mains interruptions, it is recommended that the Aquarius be powered from an uninterruptible power supply or a battery.

(> 95% dip in UT for 5 (> 95% dip in UT for 5 seconds) seconds) EMS-Power frequency (50/60 Hz) magnetic field

3 A/m

3 A/m

(IEC 61000-4-8)

Note: UT is the a.c. mains voltage prior to application of the test level. Table II

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Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Guidance and manufacturer declaration- EMC Immunity Guidance and manufacturer declaration- EMC Immunity The Aquarius is designed for use in the electromagnetic environments specified below. The user of the Aquarius has to ensure, that the device is used in such an environment. Immunity test

IEC 60601-test level

Compliance-Level

Electromagnetic environment – guidance Portable and mobile RF communications equipment should be used no closer to any part of the Aquarius , including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

EMS-Conducted Disturbances

3 Vrms 150 kHz to 80 MHz

3 Vrms 150 kHz to 80 MHz

Recommended separation distance:

(IEC 61000-4-6)

d = 1,167· √P

EMS-Radiation

d = 1,167· √P for 80 MHz to 800 MHz

(IEC 61000-4-3)

3 V/m 80 MHz to 2,5 GHz

3 V/m 80 MHz to 2,5 GHz

d = 2,33· √P for 800 MHz to 2,5 GHz Where P is the maximum output power rating of the transmitter in Watt (W) according to the transmitter manufacturer specifications and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level each frequency rangelb. Interference may occur in the vicinity of equipment marked with the following symbol:.

Note 1: At 80 MHz and 800 MHz the higher frequency range applies. Note 2: The guidelines may not apply in all situations. Electromagnetic propagation is affected by absorbation and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, a electromagnetic site survey should be considered. If the measured field strength in the location in which the Aquarius is used exceeds the applicable RF compliance level above, additional measures may be necessary, such as reorienting or relocating the Aquarius. b Over the frequency range 150 kHz to 80 MHz, field strength should be less than 3 V/m. Table III

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Recommended separation distances between portable and mobile RF communications and the Aquarius device The Aquarius is designed to operate in an electromagnetic environment, in which radiated RF-disturbances are controlled. The customer or the user of the Aquarius can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Aquarius as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of the transmitter W 0,01 0,1 1 10

Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz d = 1,167· √P

d = 1,167· √P

d = 2,33· √P

0,1167

0,1167

0,233

0,37

0,37

0,74

1,167

1,167

2,33

5,30

5,30

7,4

11,67 11,67 23,33 100 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitters, where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: For 80MHz and 800MHZ, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not be applicable in all situations. Electromagnetic propagation is affected by absorbation and reflection from structures, objects and people.

Table IV

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Edwards Lifesciences Services GmbH Edisonstr. 6 85716 Unterschleißheim Germany Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614 USA

10/2005 English, ADU_addendum Rev. E © Copyright 2005, Edwards Lifesciences LLC All rights reserved.