Aquarius Platinum Service Manual Ver 4.2 Feb 2006

Service document Aquarius Contents

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Table of Contents Table of Contents... 3 General Overview ... 7 1.

Fast View... 7

2.

General Machine Description... 8

3.

Technical Data ... 9

4.

Aquarius Component Specifications ... 10

5.

Functional Description of subsystems... 12

6.

Front View... 15

7.

Right Side View ... 16

8.

Left Side View... 17

9.

Housing Back Side View ... 18

10.

Housing In Cut A-A ... 19

11.

Housing in Cut B-B ... 20

12.

Monitor Back View... 21

13.

Monitor Housing Inside View ... 22

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Calibration instruction ... 23 1.

Introduction... 23

2.

Calibration menu screen ... 27

3.

Access / Arterial & Filtrate Pressure Monitor... 29

4.

Venous / Return & Pre-filter Pressure Monitor... 34

5.

Blood pump Aqualine ... 39

6.

Blood pump Aqualine S ... 43

7.

Blood pump high volume... 47

8.

Balance pumps Aqualine... 48

9.

Filtrate and pre-dilution pumps Aqualine S... 52

10.

Post-dilution pump Aqualine S... 53

11.

Balance pumps high volume... 57

12.

Heparin Pump ... 58

12.1

List of authorized syringes ... 62

13.

Scales... 63

14.

Blood leak detector... 67

15.

Heater check... 71

16.

Air detector / clamp test ... 74

17.

Set clock... 78

18.

Set date ... 80

19.

Optical Com 3 Test... 82

20.

Battery Test ... 83

21.

Automatic degassing unit (optional) ... 85

22.

Changing the language ... 86

23.

Electrical Safety Test... 88

24.

Technical Safety Check ... 91

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System test... 96 1.

Access / arterial pressure... 96

2.

Return / venous pressure ... 97

3.

TMP... 98

4.

Blood pump ... 99

5.

Balance pumps ... 101

6.

Clamp ... 103

7.

Scales... 104

8.

Heater... 105

9.

BLD ... 106

Schematics ... 107 1.

Function diagram... 107

2.

Master CPU 517... 108

3.

Controller CPU 517 ... 110

4.

Clamp board... 112

5.

Heater module ... 114

6.

Heparin pump module... 116

7.

Pump board ... 118

8.

Air detector module... 120

9.

Pressure module... 122

9.

Heater / scale module... 124

10.

BLD module... 126

11.

Sound board ... 128

12.

Alarm indication board ... 130

13.

Secondary power supply... 132

14.

Motherboard... 135

15.

PC 104 ground board... 137

16.

Hall sensor module... 139

17.

Motherboard 2... 141

18.

RS 232 opto board... 143

19.

Automatic degassing unit ... 145

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Wiring diagram... 148 St 8... 148 St 9... 149 St 10... 150 St 11... 151 St15... 152

Code list... 153 The expert mode ... 153 Alarm and error code... 155

Technical tips... 161 1.

Video software exchange... 161 1.1 Video software for BG-E325-00... 161 1.2 Video software for BG-E423-00... 162

2.

Master software exchange... 163 2.1 Master software for software 4.01 ... 163 2.2 Master software 3.51... 166

3.

Controller software exchange ... 169

4.

Changing the BG-E325-00 to BG-E423-00 ... 172

5.

Changing the clamp board... 178

6.

Changing the blood / balance pump ... 182

Technical descriptions... 185 1.

The balance system... 185

2.

The heparin pump... 188

3.

The pressure transducer... 189

4.

The heater system ... 191

Trouble shooting... 192 1.

BLD ... 192

2.

PC104/Display ... 194

Spare Part List ... 199

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Service document Aquarius General Overview

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General Overview 1.

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Figure I

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Service document Aquarius General Overview 2.

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General Machine Description The AQUARIUS system is an Automated Fluid Balance Monitor designed to be used with various extra corporeal treatments in the field of renal replacement therapies or plasma therapies. Toxic substances are removed by filters and cleansed blood is returned to the patient. All major components of the Aquarius are underlined in the description below. The Aquarius system is divided into two circuits: the extra corporeal (blood) circuit and the substitution or filtrate circuit. It uses a combination of four (4) peristaltic pumps to move fluid through these circuits. Four (4) pressure transducers monitor the pressures throughout the tubing system. Two (2) scales are used to accurately measure and balance filtration & substitution volumes. A heater warms the substitution fluid or dialysate before it enters into the patient circuit and fluid temperature is being monitored continuously at the degassing chamber. A syringe pump can deliver anticoagulant into the extracorporeal circuit. A blood leak detector offers protection against any blood leak in the filtration fluid. An air detector monitors the return line of the blood circuit and a return clamp will occlude the return bloodline if a potentially dangerous condition is detected. An automatic degassing unit removes automatically the air inside the degassing chamber. All operator interaction is performed through the use of a rotary push control button and four (4) membrane switches all located on the colour screen display. Electrical power is supplied via the mains power input module. The unit should always be turned ON & OFF by using the membrane panel switch on the right side of the display. The AQUARIUS protective system is designed as a 2-channel system to protect the patient from foreseeable danger.

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Technical Data •

Dimensions (all dimensions are approximate) Height (with IV pole) 180 cm Height (without IV pole) 170 cm Width 50 cm Depth 60 cm Floor space 55 cm (W) x 65 cm (D) Mass 75 kg

•

Electrical Power Requirements Mains Voltage Power consumption

115 or 230 Volts AC, 50/60Hz 500 VA

•

Electrical classification Class 1 Degree of protection against shock Type B

•

Data Plate (on rear of Aquarius)

60/50Hz

4,4/2,2A

0123

115/230 V~

•

Environmental Requirements Temperature (operation) Temperature (storage) Relative Humidity Pressure

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+21 to +35 °C -5 to +45°C 30 to 80%, non-condensing (operation & storage) 50 – 105 kPa (operation & storage)

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Aquarius Component Specifications Component

Specification

The alarm signal may be muted for a period of 2 minutes. The alarm loudness is 65 dB (A) within a distance of 1 m. Automatic degassing unit The level is controlled by an infra red beam and by pressure. A red LED (optional) indicate alarm. A green LED indicates normal operation mode. Measurement of clouding Sensitivity: 2 ml of blood in 1000 ml of filtrate at a filtrate pump flow rate of Blood leak detector 100 ml/h up to 12000 ml/h (at a hematocrit of 32%) (adjustment for TPE treatment) Input range: 30 ml/min – 450 ml/min Low flow: 10 ml/min – 200 ml/min Blood pump Flow rate accuracy: Setting ± 5% Pressure range for the specified accuracy: see defined values for access pressure and pre-filter pressure Measurement method: via strain gauge Max. load: 0 to 20 kg, max. 4 bags with 5 l of substitution fluid each or x container .. Filtrate and substitution solution accuracy: ± 50 g / ± 20 g (low flow) scale Ultrafiltration: -100 ml/h to +2000 ml/h Note: At a fluid removal rate of –100 ml/h, a maximum positive balance of 1 l is permissible. Input range: 0 or 100 – 12,000 ml/h Low flow: 0 or 100 – 11,000 ml/h Filtrate pump Flow rate accuracy: Setting ± 10% Pressure range for the specified accuracy: see defined values for filtrate pressure Adjustable substitution temperature 35°C to 39°C, adjustable in 0.5°C increments, or 0 (Off). accuracy: ± 0.5°C. Alarm is triggered if temperature is > 40°C. Heating unit Plate working range 21°C to 53°C. Alarm is triggered if temperature is > 57°C. accuracy: ± 0.3°C Syringe pump for use 50 ml syringes (Calibration necessary). Input range: 0,5 – 15 ml/h Flow rate accuracy: Setting ± 0.5 ml/h Heparin pump Heparin bolus: 0,5 – 2,5 ml/bolus via patient parameter function max. back pressure value, which does not influence the flow rate accuracy: 650 mmHg Method: Ultrasonic air bubble detection at 2.3 MHz Sensitivity: Air bubbles at a volume of 1 µl at a Air detector blood flow rate of 200 ml/min Microform at a volume of 20 µl at a blood flow rate of 200 ml/min Display monitor 10.4 “ TFT colour monitor Input range: 0 or 100 – 10,000 ml/h Low flow 0 or 100 – 4,000 ml/h Flow rate accuracy: Setting ± 10% Post-dilution pump Pressure range for specified accuracy: see specified values for return pressure The total flow rate resulting from the flow rates of pre-dilution and postdilution pump must not exceed 9000 ml/h. Input range: 0 or 100 – 10,000 ml/h Pre-dilution pump Flow rate accuracy: Setting ± 10% Pressure range for specified accuracy: see specified values for return pressure Alarm

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Service document Aquarius General Overview Component Pre-dilution pump low flow

Processors

Access pressure sensor

Prefilter pressure sensor

Filtrate pressure sensor

Return pressure sensor

TMP

Pressure Drop Return line clamp

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Specification Input range: 0 or 100 – 10,000 ml/h Low flow 0 or 100 – 6,000 ml/h Flow rate accuracy: Setting ± 10% Pressure range for specified accuracy: see specified values for return pressure 2 x CPU 80517 (Master & Controller) and 1 x Intel (Display) 1 x Atmel 89C4051 (only for ADU option) Measurement method: Contact measurement Measuring range: -250 to +200 mmHg Measuring accuracy: ± 5mmHg Upper alarm limit: automatic setting between –50 and +100 mmHg Lower alarm limit: automatic setting between -200 and -50 mmHg Alarm window size during treatment: 150 mmHg Measurement method: Contact measurement Measuring range: -150 to +500 mmHg Measuring accuracy: ± 5 mmHg Upper alarm limit: +400 mmHg Lower alarm limit: -100 mmHg Measurement method: Contact measurement Measuring range: -250 to +400 mmHg Measuring accuracy: ± 10 mmHg Upper alarm limit: +350 mmHg Lower alarm limit: - 200 mmHg Measurement method: Contact measurement Measuring range: -50 to +350 mmHg Measuring accuracy: ± 5 mmHg Upper alarm limit: automatic setting between 110 and 300 mmHg Lower alarm limit: automatic setting between 10 and 200 mmHg Alarm window size during treatment: 100 mmHg Return pressure + Pre-filter pressure - Filtrate pressure 2 Measuring accuracy: ± 10 mmHg Upper alarm limit: automatic setting to +400 mmHg Plasma therapy: at 100 mmHg Lower alarm limit at – 30 mmHg Pre-filter - return pressure Measuring accuracy: ± 10 mmHg No alarm With no power applied, the clamp is closed Occlusion of line up to 350 mmHg

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Functional Description of subsystems

The following paragraphs provide a technical overview of the operation of the subsystems that make up the Aquarius Platinum machine. AC Power entry Power enters the Aquarius through a power input module located on the left side of the machine. It houses a bi-polar rocker switch which opens both active and neutral conductors. Also included are two(2) mains fuses rated at 3.15A (230V∼) / 4A (115V∼). An incoming line filter is immediately inside the housing. Primary power supply Following on from the incoming line filter the mains power comes directly to the primary power supply located in the rear left of the housing. This is a switch mode power supply and it produces a constant +24V DC which is delivered to the secondary power supply board. Secondary power supply The +24V DC from the primary power supply comes to the secondary power supply where other used DC voltages are produced. These are +5.5V, +8V, +12.5V, +15V, -15V, +24V and are accessible by the test points down the rear edge of the board. The Secondary power supply board plugs into the main motherboard. It will detect if mains power is lost during operation and will switch over to the 18V SLA battery. It also charges the 18V battery. Motherboard The Main motherboard is located in the centre of the housing and is the main interconnection point for the subsystems within the machine. It has a backup sound maker (piezo sound cell). There are three (3) boards which plug onto the motherboard, the Secondary power supply, the Master CPU board and the Controller CPU board. Master & Controller CPU board At the core of the operation of the machine are two (2) CPU’s. The Master CPU and Controller CPU. These independently measure the devices functions and compare their results with each other. If a measured or detected response differs significantly between Master & Controller an error will be created and the machine switched into a safe mode or alarm condition. Various measured and calculated values are passed to the Display CPU for interface with the user.

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Display CPU & Screen The display CPU receives data from the Master and drives the colour screen. The user interface of a rotary main selector button and four (4) membrane switches are on the front of the screen and these are passed through this assembly back to the Master CPU. Also mounted in the top of the screen assembly are the red, amber and green status lights. Pressure Transducers (Access, Return, Pre-Filter, Filtrate) All pressure transducers are of a non-contact type. This means there is no direct interface with the blood/fluid in the tubing pathways but rather the measurement is achieved via a dry silicone interface between the disposable dome in the fluid circuit and the transducer itself. The transducer is of a wheatstone bridge principle covered with a firm silicone which transfers the applied pressure to the measurement cell. They deliver output signals of 0,5V – 9,5V/DC. On the pressure module the operation point is selected the signal amplified, and the signals are send to the CPU’s. Pumps (Blood, Pre dilution, Post dilution, Filtrate) The pumps have a 24V/DC motor with a max. current of 10A and a gear of 6:1. They also have an included rev counter. The motor is driven by a pulse width signal, which is send out from the Master CPU. The speed and the calculated delivery rate is controlled by the CPU’s. Four hall sensors allow the pumps to stop at the parking position after the system test to put in the tubes easily. Heparin pump The heparin pump is a multi syringe pump. The pump gets its position from the output voltage of a potentiometer (0V - 10V). The motor is driven by an IC (L6202). The direction is selected by a logical element (4070). Scales (Substitution, Filtrate) The scales work with lengthening effect resistors (stain gauges). Each scale has two of them (master/controller). They deliver output signals of 0,5V - 9,5V/DC. The signals are changed on the heater/scale module to digital signals and multiplexed. The multiplex signal are send to the CPUs. Blood leak detector The blood leak detector photo module sends out a red light, that’s reflected by a mirror. With a photo diode the returning light is measured. The signal is filtered and amplified at the blood leak module and from there sent to the CPUs.

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Heater and degassing chamber Two heating plates (door and housing ) heat the substitution. They are connected to main voltage. The heater elements are controlled via the heater module being switched on and off by the Master CPU via a solid state relay with a backup relay control through the Controller CPU. The feedback is provided through four (4) thermocouple sensors in the system. Two (2) detect the plate temperature of the plate on the housing side of the device and two (2) providing feedback from the substitution fluid at the degassing chamber. One (1) of the substitution sensors is in series with the chamber detection micro-switch and this returns to the Master CPU. A correct fitting of the chamber is controlled by this micro-switch. No degassing chamber will limit the heating temperature of the plates. Automatic degassing unit (optional) Two hydrophobic filter prevent the Aquarius degassing unit from penetration of substitution liquid. One hydrophobic filter is located outside, one is located inside the box. The level is controlled by infra red light beam and pressure. The Aquarius degassing unit is an microprocessor controlled system. The degassing unit works independent from the Aquarius, except the power supply. Air detector The air detector is an ultrasonic system at a frequency of 2.3 MHz. Test signals, that simulate an air detection each 30 ms, make sure that the air detector module is still working. A detected alarm is send to the master and controller, which stop the balance system, blood circuit and close the clamp. Clamp The return line clamp is closed with a mechanical force. During the treatment the clamp is closed by a magnetic system. A hall sensor controls if the clamp is actual closed or opened. During a power fail without battery the clamp opened.

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Front View

Figure II

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Right Side View

Figure III

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Left Side View

Figure IV

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Housing Back Side View

Figure V

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10. Housing In Cut A-A

Figure VI

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11. Housing in Cut B-B

Sound module BG-E412

Fan

Motherboard BG-E415

Heater module BG-E402

Air detector module BG-E406

Figure VII

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12. Monitor Back View Alarm indication light

Display

Optical encoder

Figure VIII

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