AQUARIUS – Regular Technical Service Manual Rev B Ver 6. Citrate Released Aug 2008

Service document Aquarius Contents

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1.Table of Contents 1.Table of Contents... 3 2.General Overview ... 8 2.1.

Fast View... 8

2.2.

General Machine Description... 9

2.3.

Technical Data ... 10

2.4.

Aquarius Component Specifications ... 11

2.5.

Functional Description of subsystems... 13

2.6.

Front View... 17

2.7

Right Side View ... 18

2.8

Left Side View... 19

2.9

Housing Back Side View ... 20

2.10

Housing In Cut A-A ... 21

2.11.

Housing in Cut B-B ... 22

2.12.

Monitor Back View... 23

2.13.

Monitor Housing Inside View ... 24

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3. Calibration and maintenance instruction ... 25 3.1. Cleaning instruction... 25 3.1.1 Cleaning the cabinet interior ... 25 3.1.2 Cleaning the ventilation grids ... 25 3.1.3 Cleaning the mirror and optical components of the blood leak detector... 25 3.2. Visual check... 26 3.2.1 Labelling... 26 3.2.2 Mechanical conditions ... 26 3.3. Accessories ... 27 3.3.1 Hook and IV pole... 27 3.3.2 Power cable... 27 3.3.3 Operator manual ... 27 3.4.

Calibration introduction ... 28

3.5.

Calibration menu screen ... 31

3.6.

Measuring the voltages ... 34

3.7. Pressure Calibration ... 36 3.7.1 Access / Arterial Pressure Monitor... 36 3.7.2 Filtrate Pressure Monitor ... 41 3.7.3 Pre-filter Pressure Monitor... 42 3.7.4 Venous / Return Pressure Monitor... 46 3.8. Pump Calibration... 47 3.8.1 Blood pump ... 47 3.8.1.1 Blood pump Aqualine ... 47 3.8.1.2 Blood pump Aqualine S ... 51 3.8.1.3 Blood pump high volume... 54 3.8.2. Treatment pumps ... 55 Filtrate pump Aqualine ... 55 3.8.2.1 3.8.2.2 Filtrate pump Aqualine S ... 59 3.8.2.3 Filtrate pump high volume ... 59 3.8.2.4 Postdilution pump Aqualine ... 59 3.8.2.5. Postdilution pump Aqualine S ... 60 3.8.2.6 Postdilution pump high volume... 63 3.8.2.7 Pre-dilution pump Aqualine ... 63 3.8.2.8 Pre-dilution pump Aqualine S ... 63 3.8.2.9 Pre-dilution pump high volume... 63 3.8.3. Anticoagulance pumps ... 64 3.8.3.1 Heparin pump... 64 3.8.3.2 Citrate pump... 68 3.8.3.3 Calcium pump ... 69

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3.9. Scale Calibration... 70 3.9.1 Balance scales ... 70 3.9.1.1 Substitution scale... 70 3.9.1.2 Filtration scale ... 73 3.9.2 Anticoagulance scales ... 74 3.9.2.1 Citrate scale ... 74 3.9.2.2 Calcium scale ... 78 3.10.

Blood leak detector... 79

3.11

Heater check... 82

3.12. Air detector / clamp test ... 84 3.12.1 Air detector... 85 3.12.2 Venous clamp ... 86 3.13. Set time and date ... 87 3.13.1 Set time ... 87 3.13.2 Set date ... 89 3.14.

Plasma filtration... 91

3.15.

Adsorber entry pressure ... 91

3.16.

Adsorber exit pressure ... 91

3.17.

Optical Com 3 Test... 92

3.18. Battery Test ... 93 3.18.1. Check the main battery... 93 3.18.2 Checking / Changing the PC104 battery... 94 3.19

Automatic degassing unit ... 95

3.20.

Changing the language ... 97

3.21.

Changing the log mode ... 100

3.22. Fan Test... 105 3.22.1 Main Fan ... 105 3.22.2 PC 104 Fan ... 105 3.23 Electrical Safety Test... 106 3.24. System test ... 110 3.24.1 General system test... 110 3.24.2 LED test... 110 3.24.3 Priming... 110 3.24.4 Clamp and pressure test... 110 3.25. Treatment simulation... 111 3.25.1 Treatment simulation at the customer... 111 3.25.1.1 General treatment test... 111 3.25.1.2 ADU... 111 3.25.2 Treatment simulation in the repair centre... 112 3.25.2.1 General treatment test... 112 Aquarius RCA / Citrate Service Manual Doc. Nr. EU-F2007/02 Rev. B

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3.26 Technical Safety Check ... 114 3.27.

Technical Safety Check ... 120

4. System test... 121 4.1.

Access / arterial pressure... 121

4.2.

Return / venous pressure ... 122

4.3.

TMP... 123

4.4.

Blood pump ... 124

4.5.

Balance pumps ... 126

4.6.

Clamp ... 128

4.7.

Scales... 129

4.8.

Heater... 130

4.9.

BLD ... 131

5. Schematics ... 132 5.1

Function diagram... 132

5.2

CPU 517 BG-E425(Mega CPU) ... 133

5.3.

Clamp board... 135

5.4

Heater module ... 137

5.5

Heparin pump module... 139

5.6

Pump board ... 142

5.7

Air detector module... 144

5.8

Pressure module... 146

5.9

Heater / scale module... 148

5.10

BLD module... 150

5.11

Sound board ... 152

5.12

Alarm indication board ... 154

5.13

Secondary power supply... 156

5.14

Motherboard... 159

5.15

C 104 ground board ... 161

5.16

Hall sensor module... 163

5.17

Motherboard 2... 165

5.18

Automatic degassing unit ... 167

5.19

Citrate board ... 170

5.20

Communication board... 172

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6. Wiring diagram... 174 6.1

St 8... 174

6.2

St 9... 175

6.3

St 10... 176

6.4

St 11... 177

6.5

St15... 178

7.Code list... 180 7.1

The expert mode ... 180

7.2

Alarm and error code... 182

8.Technical tips... 188 8.1.

Video software exchange... 188

8.2.

Master software exchange... 189

8.3

Controller software exchange ... 192

8.4.

Changing the clamp board... 195

8.5.

Changing the blood / balance pump ... 199

9. Technical descriptions... 203 9.1.

The balance system... 203

9.2.

The heparin pump... 206

9.3.

The pressure transducer... 207

9.4.

The heater system ... 213

10. Trouble shooting... 214 10.1.

BLD ... 214

10.2. PC104/Display ... 216

11. Spare part list... 221

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Service document Aquarius General Overview

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2.General Overview 2.1. Fast View Alarm indication light

Push button

Blood pump

Postdilution pump

Pre-filter pressure Predilution pump Filtration pump sensor Filtrate pressure sensor

Blood leak detector

Heparin pump with Automatic Degassing Unit Citrate pump Return pressure sensor Calcium pump

Air detector Access Clamp pressure sensor

Filtration scale

Citrate scale

Substitution scale

Calcium scale

Figure I

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2.2. 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 cleaned 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 / 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 before it enters into the patient circuit and fluid temperature is being monitored continuously at the degassing chamber. An automatic degassing unit removes automatically the air inside the degassing chamber. A syringe pump can deliver heparin into the extracorporeal circuit. A citrate and calcium anticoagulant system is optional available. In this case two (2) peristaltic pumps deliver the citrate and calcium in the blood circuit. The delivered amount is controlled by two (2) scales. 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. 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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2.3. Technical Data •

Dimensions (all dimensions are approximate) Height (with IV pole) 180 cm Height (without IV pole) 175 cm Width 65 cm Depth 75 cm Floor space 55 cm (W) x 65 cm (D) Mass 90 kg

•

Electrical Power Requirements Mains Voltage Power consumption

115 or 230 Volts AC, 50/60Hz 350 VA

•

Electrical classification Class 1 Degree of protection against shock Type B

•

Data Plate (on rear of Aquarius)

•

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

Aquarius RCA / Citrate Service Manual Doc. Nr. EU-F2007/02 Rev. B

+16 to +35 °C -5 to +45°C 30 to 80%, non-condensing (storage) 10 to 90%, non-condensing (operation) 50 – 105 kPa (operation & storage)

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2.4. 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. 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%) (automatic 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 10 – 12,000 ml/h Low flow: 0 or 10 – 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). Heating unit Alarm is triggered if temperature is > 40°C / < 33°C. Plate working range 21°C to 53°C. Alarm is triggered if temperature is > 57°C. Syringe pump for use 50 ml syringes (Calibration necessary). Input range: 0 or 0,5 – 15 ml/h Flow rate accuracy: Setting ± 0.5 ml/h Heparin pump Heparin bolus: 0,5 – 2,5ml/bolus via patient parameter function max. back pressure value, which does not influence the flow rate accuracy: 650 mmHg Input range: 0 or 4 – 1,000 ml/h Citrate / Calcium pump (optional) Flow rate accuracy: Setting ± 10% Measurement method: via strain gauge Citrate and Calcium scale Max. load: 2 kg (optional) accuracy: 2g Method: Ultrasonic air bubble detection at 2.3 MHz Sensitivity: Air bubbles at a volume of 1 µl at a blood flow rate of Air detector 200 ml/min Microform at a volume of 20 µl at a blood flow rate of 200 ml/min Alarm

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Component

Specification

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% The total flow rate resulting from the flow rates of pre-dilution and postdilution pump must not exceed 10000 ml/h (4000 ml/h for low flow). Input range: 0 or 100 – 10,000 ml/h Flow rate accuracy: Setting ± 10% The total flow rate resulting from the flow rates of pre-dilution and postdilution pump must not exceed 10000 ml/h (6000 ml/h for low flow). 2 x CPU 80517 (Master & Controller) and 1 x Intel (Display) 1 x Atmel AT89C4051 1 x PIC 18F248 (only for non Citrate option) 2 x PIC 18F248 (only for Citrate option) Measurement method: Contact measurement Measuring range: -250 to +200 mmHg Measuring accuracy: ± 5mmHg Upper alarm limit: automatic setting between –50 and +200 mmHg Lower alarm limit: automatic setting between -250 and 0 mmHg Alarm window size during treatment: 200 mmHg Measurement method: Contact measurement Measuring range: -150 to +500 mmHg Measuring accuracy: ± 5 mmHg Upper alarm limit: +400 mmHg Lower alarm limit: 0 mmHg Measurement method: Contact measurement Measuring range: -400 to +400 mmHg Measuring accuracy: ± 10 mmHg Upper alarm limit: +350 mmHg Lower alarm limit: - 350 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

Post-dilution pump Pre-dilution pump

Processors

Access pressure sensor

Pre-filter pressure sensor

Filtrate pressure sensor

Return pressure sensor

TMP

Pressure Drop Return line clamp

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 + 35 mmHg (static pressure) Measuring accuracy: ± 10 mmHg No alarm With no power applied, the clamp is opened Occlusion of line up to 350 mmHg

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2.5. 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 +5.3V, +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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Master Extension The master extension board is a microcontroller (PIC18F) to extent the master CPU. Various values are measured and calculated. A communication to the master CPU is realized via the RS 232 communication board. Citrate machines are equipped with a citrate board instead of the master extension board. See also Citrate and Calcium unit. Display CPU & Screen The display CPU (PC 104) 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, yellow 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 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 (see also 3.12.1 list of authorized syringes). The pump gets its position from the output voltage of a potentiometer (0V - 10V). The motor is driven by an microcontroller. The microcontroller gets its signals from the master CPU. Citrate and Calcium unit (optional) The citrate and calcium unit includes a citrate master and citrate controller system. Both systems do have a microcontroller (PIC 18F). The citrate master system communicates with the citrate controller system and the master CPU, the citrate controller system communicates with the citrate master system and the controller CPU. The citrate and calcium pumps are driven by the citrate master and controlled via the citrate and calcium scales.

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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. Scales (Citrate, Calcium) (optional) The scales work with lengthening effect resistors (stain gauges). They deliver output signals of 0,5V - 9,5V/DC. The signal goes directly to the master system on the citrate/ calcium unit. Pumps(Citrate, Calcium) (optional) The pumps have an integrated micro stepping drive high torque motor driven by 24V. They also have an optical two channel encoder. The pumps are controlled by the citrate microcontrollers. 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. 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 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.

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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. Communication system with Citrate option PC 104 / Display

Master CPU

Controller CPU

Citrate board Citrate Controller

Citrate Master

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Front View IV Pole BG-F586

Display OD-E006

Pressure transducer BG-F554

Post-dilution pump rotor BG-F581 Pump door BG-F573 Pre-dilution pump rotor BG-F581

Blood pump rotor BG-F580 Pump door BG-F573 Filtrate pump motor BG-F582 Pressure transducer BG-F554

Heparin pump with ADU BG-F697

Citrate pump rotor BG-F683 Pump door BG-F573

Sensor air detector BG-F586

Calcium pump rotor BG-F682

Pressure transducer BG-F710

Hook BG-F650

Roller without break KT-F277 Roller with brake KT-F276 Figure II

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2.7 Right Side View

Touch Panel (on/off) SE-F094

Heater plate door BG-F560 Heater plate housing BG-F559

Hook BG-F650

Figure III

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2.8 Left Side View

Fuse SZ-E031

Blood leak detector BG-F563

Power input unit SE-F074

Hook BG-F650

Figure IV

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2.9 Housing Back Side View

Fan BG-F559

Motherboard 1 BG-E415

Citrate board BG-E430

Primary Power Supply NE-E004

Storage battery KM-E041 Heater / Scale module BG-F409

Figure V

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Housing In Cut A-A

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Hall sensor module BG-E417

Pressure Module BG-E429

PCB pump motor BG-E305 Pump motor BG-F556

Citrate / Calcium pump motor BG-F712-00

Primary Power Supply NE-E004

Line Filter IE-E007

Figure VI

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