Aitecs 2015 Service Manual

1. INTRODUCTION 1.1.

GENERAL INFORMATION

The Aitecs 2015 syringe pump is designed to accurately control the delivery of solution to the patient by means of a disposable syringe. The Aitecs 2015 syringe pump is compatible with a wide range of standard, single-use, disposable Luer-lock syringes, ranging from 10ml to 100ml in size. This SERVICE MANUAL describes the theory of operation, how to check, troubleshoot and repair Aitecs 2015 syringe infusion pump. Ensure that you are fully familiar with this equipment by carefully studying the Operator’s Manual and this Service Manual prior to attempting any repairs or servicing. 1.2.

GENERAL PRECAUTION

Please read the general Operating Precautions described in the Operating Instructions carefully prior to using this pump. This pump contains static-sensitive components. Observe strict precautions for the protection of static sensitive components when attempting to repair and service the pump. An explosion hazard exists if the pump is used in the presence of flammable materials. Exercise care to locate the pump away from any such hazardous sources. An electrical shock hazard exists if the pump casing is opened or removed. Refer all servicing to qualified service personnel.

This pump is protected against the effects of high-energy radio frequency emissions and is designed to fail-safe if extremely high levels of interference are encountered. Should false alarm condition be encountered, either remove the source of the interference or regulate the infusion by another appropriate means. If the pump is dropped, subjected to excessive moisture, humidity or high temperature, or otherwise suspected to have been damaged, remove it from service for inspection by a qualified service engineer.

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2. TECHNICAL DESCRIPTION 2.1.

GENERAL

The Block Diagram of the pump is given in the section 8.1. The Electrical Schematic Diagram is given in the section 8.2. The pump is composed of the following elements: -

Keypads Stepper motor Stepper motor encoder Syringe Force sensor Syringe plunger grippers and pusher lever sensor Drive engagement sensor Syringe size sensor Pusher position sensor Syringe barrel sensor Battery unit Electronic board Drive Unit board Power Supply Unit IRDA/RS232/Nurse Call Interface Hard bootstrap loader

Below follows a description of these elements, refer the appropriate diagram for full understanding of the functionality: 2.1.1. Keypads Keypad K1 comprises of a 4 x 3 key matrix connected to the Electronic board at connector JP1. The ON/OFF key and BATTERY & MAINS LED’s are also located on the K1 keypad connect to the Electronic board via JP12. Keypad K2 comprises of a 4 x 2 key matrix. It is connected to the Electronic board via connector JP4. 2.1.2. Stepper motor A two-phase unipolar stepper motor with 7.5º step-angle is used in the pump drive. The motor is connected to the Drive Unit board via connector P5 and is driven in micro stepping mode. There are 48 steps to complete one full revolution of the motor shaft. The motor is connected to the lead screw by means of timing belt. The belt ratio is 5:1; as a result 240 motor steps move the drive carriage by 1 mm. 2.1.3. Stepper motor encoder Motor speed and direction is monitored by means of the encoder. It is composed of two photointerrupters D1, D2 and a 9 slot-encoding disk mounted on the stepper motor shaft. Quadrature signals (Tax1, Tax2) are transferred to the Drive Unit board via P6 connector.

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2.1.4. Syringe force sensor As a syringe force sensor is used a strain gauge TZ1 mounted on a steel plate within the plunger retaining mechanism. When this plate is deflected by applied force on the plunger mechanism, a differential voltage is generated at gauge output. This signal, which magnitude is proportional to the applied force, is transferred to the Drive Unit board. 2.1.5. Syringe retainer (plunger grippers and pusher lever) sensors The plunger grippers and pusher lever sensors are composed of photo interrupters D4, D5, D6. The LED’s of the photo interrupters are supplied with pulse-modulated current through pin 8 of JP1 connector of the Drive Unit board. When the syringe is loaded, the shutters controlling the photo interrupters D4 and D6 are opened. When the pusher lever is lifted up, the shutter controlling the photo interrupter D5 is opened. Output signals of these sensors are summed to form syringe retainer output voltage (at pin 7 of JP1 – Drive Unit board) in accordance with the Table 1. Plunger grippers sensors (D4, D6) Off On

Pusher lever sensor (D5) Off Off

Off

On

On

On

Syr. retainer output voltage <0.3V ≥0.3V; ≤0.6V >0.6V; ≤0.95V >0.95V; ≤1.4V

Table 1 2.1.6. Drive engagement sensor The drive engagement sensor is comprised of photo interrupter D3. Its LED is supplied with pulse-modulated current. When the half-nuts of drive are closed (engaged), the shutter controlling the photo interrupter D3 is open and electrical pulses are generated at pin 6 of the Drive Unit’s board JP1 connector. 2.1.7. Syringe size sensor The syringe size sensing is achieved using the linear potentiometer R1. The signal from the potentiometer slider is applied to the Electronic board via pin 2 of JP8 connector. 2.1.8. Pusher position sensor An optical absolute encoder of pusher position is comprised of a steel encoder ruler and photo interrupter D7. Ruler is attached to the drive walls, and the photo interrupter is mounted on the drive carriage and moves along ruler during infusion so that edge of the ruler is inside the gap of photo interrupter. The edge of the ruler is punched with the slots distributed with various intervals in certain pattern. Each slot passing the gap generates electrical pulse when the photo interrupter is moved along the ruler. Microcontroller permanently monitors width of intervals in

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sequence of pulses and determines pusher position basing on combination of passed intervals. Obviously, certain number of slots should be passed after start of infusion before the pusher position (and, correspondingly, remaining time and volume) may be determined. Maximum delay is when the pusher is at the rightmost position (up to 9 mm of pusher travel may be required). 2.1.9. Syringe barrel sensor The syringe barrel sensor comprises switch S1. When the syringe is loaded, the switch S1 contacts are closed and a logic “0” is generated at pin 1 of the Electronic board’s JP5 connector. 2.1.10. Battery unit The battery unit comprises the Ni-MH (7,2V x 2.5Ah) battery GB1 together with the battery monitoring circuit. The integrated circuit U1 monitors battery voltage, temperature and charge/discharge current. This data is used to calculate battery charge state and remaining working time when pump runs on battery. Data is transferred to the microcontroller via 1-Wire interface (pin 4 of the JP7 connector). R2 is a current sense resistor; R3 and C1 constitute a low pass filter for the current monitoring circuit. Thermistor R1 terminates battery charging if battery temperature exceeds the permissible value. The resettable fuse F1 protects against a short circuit of the battery. 2.2.

ELECTRONIC BOARD

The electrical diagram of the Electronic board is given in section 8.3. It comprises following main parts: - Microcontroller circuit - Display unit - Display contrast regulator - RS232 interface - Watch-dog circuit - Piezotransducer drive - Reference voltage source - LED indicators 2.2.1. Microcontroller circuit The 16 bit microcontroller U12 (SAB-C167CR-LM) controls and monitors major syringe pump functions. Clock pulses are generated by the quartz oscillator Q1 at a frequency of 3.686400 MHz and multiplied x 5. Supervisor integrated circuit U9 generates a reset signal for the microcontroller when the supply voltage changes from 0V to 5V. Software instructions are stored in 1-Megabyte FLASH memory U10. Device constant parameters are stored in 8-kilobyte SPI EEPROM, U14. Temporary variables are stored in 128 kilobyte SRAM U8 with real time clock and lithium battery.

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The microcontroller functions include: -

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Scanning the keypad via the port P8 and the buffers of the U2 and U4 ICs. The keypad status information is read via other buffers of the U2 and U4 ICs to the inputs P5.9 (pin 36), P5.10 (pin 39) and P5.11 (pin P40). Setting the output P2.10 (pin 59) to ‘0’on switching the pump on. This signal maintains power supply active. In order to switch power off, the ON/OFF key shall be kept depressed, thereby setting the P5.7 input (pin 34) to ‘1’. After 3 sec delay micrcontroller sets the P2.10 output (pin 59) to ‘1’, which switches the power supply off. Detecting pump connection to 100-240VAC mains power or 12VDC by the signal at the P5.6 input (pin 33) (‘1’ – when connected). At this state transistor T11 opens thereby activating the MAINS indicator on the front panel. When pump is running on internal battery, microcontroller activates the BATTERY indicator by setting the P2.0 output (pin 47) to ‘1’. Obtaining information from the battery monitoring circuit on the battery voltage, temperature and capacity via the input P7.6 (pin 25); obtaining battery fast charge signal via the P5.14 input (pin 43) (‘0’ – fast charge in progress); disabling the AC mains supply by setting the P7.4 output (pin 23) to ‘1’ in the battery calibration mode. Activating the Nurse Call circuit located at the Supply Unit, by setting the P2.5 output (pin 52) to ‘1’. Receiving voltage proportional to syringe size from the syringe size sensor via the AN0 input (pin 27). Force sensor reference voltage is applied to the AN1 input (pin 28). Voltage directly proportional to force acting on the syringe pusher, is applied to the AN2 input (pin 29). Force sensor reference 0 voltage is applied to the AN3 input (30 pin). Syringe retainer output voltage (see table 1) is applied to the input AN4 (pin 31). Voltage from piezo transducer current monitor is applied to the input AN5 (pin 32). The P2.12 output is used for controlling force sensor’s supply. Controlling (pulse modulating) the current through the LEDs of the drive engaged, gripper and pusher lever sensors via the P2.13 output (pin 62); receiving signal of engagement of drive half-nuts with lead screw (‘1’ pulses) via the P5.13 input (pin 42) (via the buffer U20); receiving signal that syringe barrel is fitted (‘0’ level) via the P5.12 input (pin 41) (via the buffer U4E); receiving tachometer pulses from the Drive Unit board via the P2.15 input (pin 64). Prior to starting motor rotating backwards and during it microcontroller sets the P2.11 output (pin 60) to ‘0’ to disable motor direction sensor in the Drive Unit board; during normal infusion this output is set to ‘1’. Generating signals for the stepper motor controller/driver which is located in the Drive Unit board: Data A via the P2.6 output (pin 53), Data B via the P2.7 (pin 54), Strobe A,B via the P2.8 (pin 57), Clock A,B via the P2.9 (pin 58). Signal controlling magnitude of motor winding current is generated at the POUT0 output (pin 19) by means of PWM; AC component of this signal is suppressed by means of the second order low-pass filter (R54, C71, R56, C73), and DC component having range 0.4 to 2.5 V is transferred via the diode D23 and pin 4 of JP10 to the Drive Unit board – REF/ENABLE A,B circuit. This circuit is used also for disabling motor driver by applying +5 V to it. For this sake pin 4 of JP10 is also connected with the P7.7 output of microcontroller (pin 26) and output of watchdog via the D21 and D22 correspondingly; logic ‘1’ at any of these two

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outputs sets windings current to zero (e.g. in STOP mode, during pause between two adjacent steps or when the watchdog is activated). Selecting IRDA rate via the P6.4 output (pin 5). Selecting of UART connection either with the RS232 or IRDA interface via the P6.5 output (pin 6). The P6.7 output is set to ‘1’ when RS232 selected, and ‘0’ is set when IRDA interface selected. Activates Z1 buzzer by setting output P6.7 to ‘1’ when piezotransducer circuit is interrupted; receiving interrupt pulses from the SRAM (U8) Real Time Clock via the T2IN input (pin 74); receiving pulses from the syringe pusher position sensor via T4IN input (pin 70).

2.2.2. Display unit A 240 x 64 dot blue negative graphic LCD display (MD1) is used in the pump. The backlight is controlled by means of PWM, using control signal generated at the POUT2 output (pin 21) of the microcontroller. 2.2.3. Display contrast regulator Negative voltage adjustable within range of 7.5 to 8.5 V is utilized to control the display contrast. The negative voltage is generated by means of the DC/DC converter U16, and voltage regulator U17. Initial voltage value is adjusted by means of trimmer potentiometer R52. The microcontroller U12 then controls display contrast by means of PWM signal generated at the POUT3 output (pin 22) and applied to pin6 of the U17 via low-pass filter R50, C60 and diode D19. 2.2.4. RS232 interface circuit The RS232 interface circuit is isolated from the pump circuitry by means of the opto-couplers D8, D9. This isolated part of the circuit is powered from the PC COM port using RTS (+10V) and DTR (+10V), rectified by means of the D6, D7 diodes signals. Voltage regulator U1 is used to provide the RS232 interface chip U3 with +5V supply (VDD). U3 includes a DC/DC converter providing the necessary voltages of +7V and –7V. Integrated circuit U3 hibernates when no valid receiver level and no receiver or transmitter transient is detected for 30 seconds, and wake up when a valid receiver level or receiver or transmitter transient is detected. 2.2.5. Watchdog circuit The watchdog function is carried out by the uP supervisory circuits with windowed (Min/Max) watchdog U9. The microcontroller generates clocks at the P2.4 output (pin 51) that are applied to the WDI input (pin 3 of U9). If the clock period goes outside the permissible range, U9 generates a short logic ‘0’ pulse at the WDP0 output (pin 5). This pulse sets ‘1’ at the Q output (pin5) of the flip-flop U6A, which acts as follows: 1) Stops motor (via the D22), 2) Activates red alarm LED D1 (via the D4), 3) Activates the nurse call circuit located in the Supply Unit (via the D16),

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4) Launches the buzzer Z1 (via the D10), 5) Eliminates 3 s delay when switching the pump off (via the input 5 of U11), 6) Indicates to the microcontroller U12 that watchdog is activated (via the P5.8 input – pin 35). The watchdog circuit is also activated if the motor starts rotating backwards despite forward rotation commands. In this case the rotation direction sensor in the Drive Unit board sets “Backwards” circuit (pin 3 of JP9) to ‘0’ which inputs logic “0” to the watchdog (via D18) thus activating it. The pump carries out watchdog test each time it is powered up, and if test passes successfully U6B trigger Q output (pin 9) is set to ‘0’, if test fails – Q output is set to ‘1’. This watchdog signal is applied to the 67 pin of U12 microcontroller. 2.2.6. Piezotransducer drive The audible signal is generated by means of PWM at the POUT1 output (pin 20) of the microcontroller U12. Carrier frequency is suppressed by third order low-pass filter (R58, C75, R60, C76, R61, C77). In order to obtain double maximal output voltage a bridge layout of the U18 amplifier is used. The ratio of R64 and R67 determines audio gain. R77 monitors current applied on the piezotransducer. Signal from the R77 is amplified by the U18A amplifier, rectified with the D21, C86 and applied to the AN5 input (pin 32) of the U12 microcontroller. 2.2.7. Reference voltage source Voltage regulator U7 generates voltage Vref used as reference for the microcontroller’s ADC and the syringe size sensor. U7 is switched on/off by microcontroller (via the P6.6 output). 2.2.8. LED indicators The red LED indicator D1 flashes when an ALARM condition is detected or when the watchdog circuit is activated. It is controlled by the microcontroller U12 via the P2.2 output (pin 49) or by the watchdog (via the D4). The Green LED D2 flashes during infusion. It is controlled via the P2.3 output (pin 50) of the microcontroller. The orange LED D3 flashes in ALERT condition. It is controlled via the P2.1 output (pin 48). 2.3. DRIVE UNIT BOARD

The drive electronics is located on the separate PCB attached to drive mechanical assembly. Controller-driver U2 is used to operate the stepper motor. It controls current through motor windings by means of the PWM using control signals from the microcontroller: “Data A” (pin 6 of the U2), “Data B” (pin 17), “Strobe A,B” (pins 2, 13), “Clock A,B” (pins 5, 16), “REF/ENABLE A,B” (pins 3, 14). Each step of the motor consists of 8 successive micro-steps, which provide regulation of current through windings closely to sin/cos law, thus ensuring smooth rotation of the motor shaft. In the case the watchdog is actuated, a high level (+5V) signal is applied to the “REF/ENABLE A,B” inputs, which removes power from the motor windings. Quadrature signals from the motor encoder are processed by means of the decoder built on the U6, U7, and U8 integrated circuits. 9 square pulses are generated at the TAX output (pin2 of JP2) during one revolution of motor shaft. The “BACKWARDS” output is used to indicate

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direction of motor rotation. Logic “0” is generated at this output if motor starts rotating so as to move syringe pusher backwards while logic “1” is applied to the FWD input (i.e. motor should not rotate backwards). Logic “0” applied to the FWD input (pin 1 of JP2) disables the direction sensor and ensures that logic “1” is set at the “BACKWARDS” output regardless of rotation direction. The operational amplifier U1 amplifies syringe force sensor’s output signal. Integrated circuit U3 produces precise supply voltage +5V both for the syringe force sensor and amplifier U1. The trimmer potentiometer R2 is used to balance the force gauge (bridge). U5A performs buffering of syringe retainer output signal, and U5B performs conditioning of pusher position sensor’s signal. 2.4. POWER SUPPLY UNIT

The power supply unit includes switching power supply PS1, +5V voltage regulator U2, and accumulator battery fast-charge controller U1 together with transistor T4. Protective circuits built using comparators U3, U6 and thyristors D6, D7 are intended to prevent occurrence of over-voltage and under-voltage at the +5V supply circuit in the case of failure of voltage regulator or short circuits within pump electronics. Voltage in the VccNS circuit is approximately +11V when pump is connected to the mains, and approximately +7V when disconnected (powered from the internal battery). Vcc voltage is +5V when pump is switched on, and 0 when switched off. The +5V regulator (U2) is switched on when VccNS voltage is applied to its “ON/OFF” input (pin 2), which occurs when the operator presses the pump’s ON/OFF key. The regulator is switched off by means of the “SHDN” signal, which is generated by microcontroller when the operator depresses the ON/OFF key for 3 seconds. The T8 transistor key is used for switching mains supply off in the course of the accumulator battery test. The controller U1 initiates fast charge of accumulator battery each time the pump is connected to the mains. Detecting a negative battery voltage slope, which occurs when charge is completed, normally terminates fast charge. For safety reasons termination of the fast charge is provided by means of the thermistor within the battery pack detecting over-temperature. Additionally, termination of fast charge is provided on elapsing of established fast charge time. After termination of fast charge the controller switches to trickle charge mode. A socket is located on the pump for powering from an external 12VDC source. This circuit comprises a connector on the rear side of pump and fuses F2, F3, and filter components L1, L2, C21, C22 mounted on the power supply unit’s PCB. Diode D10 prevents pump from damaging in case of wrong polarity of external 12 VDC source. 2.5. IRDA/RS232/NURSE CALL INTERFACE

2.5.1. IRDA interface Serial infrared data communication is operating in accordance with the IRDA standard using modulator-demodulator U4 and transceiver U5 located on the power supply’s PCB.

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The transceiver is mounted on the rear of the PCB, in front of the window at the back of the pump. The window is covered with dark IR-transparent plastic. 2.5.2. RS232 interface The technical specification of the RS232 Interface is listed in table 2 below: Connector TXD Output Voltage Range RXD Input Voltage Range RXD Input Thresholds RXD Input Resistance Isolation Socket/pump Baud Rate Bit Format

Table 2 D Type –9 Pin, female Minimum: -5V(mark), +5V(space) Typical: -5.4V(mark), +5.4V(space) with 3kohm load to ground -25V - +25V maximum Low: 0.8V minimum/ High: 2.4V maximum 3 kohm minimum 4 kV 115 kBaud 1 start, 8 data, no parity, 1 stop

RS232 connections data: 1 - Not used 2 - Transmit Data (TXD) Output 3 - Received Data (RXD) Input 4 - Power Input (DTR) 5 - Ground (GND) 6 - Not used 7 - Power Input (RTS) 8 - Not used 9 - Not used 2.5.3. Nurse Call Interface Nurse call interface is implemented using relay RL1 located on the power supply’s PCB. Contacts are rated at 1A at 50VAC or 1 A at 30VDC. Relay contacts are accessible at the connector on the rear of the pump. After detecting an alarm condition the microcontroller sets a logic “1” at its P2.5 output (pin 52), which opens transistor T3 on the power supply’s PCB and the relay is activated. If a failure of the microcontroller is detected an output signal from the watchdog circuits activated the relay. 2.6. BOOTSTRAP LOADER UNIT

A bootstrap loader unit is used for downloading bootstrap into the Flash memory U10 on the Electronic board, utilizing microcontroller’s U12 internal bootstrap loader, when the Flash memory’s software does not contain bootstrap or it does not work. Bootstrap loader unit is connected to the JP6 connector of the Electronic board. It allows launching the U12 microcontroller by means of manual reset signal, maintains Power Supply Unit active, commutates UART via the RS232 interface and configures the microcontroller so as to launch its internal bootstrap loader.

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3.

USER CONFIGURATION MENU

key and turn the pump on. Enter code 237 using the numerical keypad. Depressed the Press OK to confirm the code. The User Configuration Menu will be displayed. Use the softkeys to select the required parameter (see Operator’s Manual).

4.

SERVICE MENU

key turn the pump on. Enter code 751 using the numerical While keeping pressed the keypad. Press OK to confirm the code. The Service Menu will be displayed. Use the softkeys to select the required parameter. 4.1.

MAINTENANCE MENU

Select the MAINTENANCE MENU from the Service menu and press the OK softkey. Use the softkeys to select the required parameter. Press the OK softkey: - to modify the NEXT SERVICE DATE - to view the selected LOG (event, use, key or service) - to set TIME FORMAT (24h or 12h) - to set DATE FORMAT (dd-MM-yyyy or MM-dd-yyyy) - to set DEFAULT PARAMETERS - to set ALARM PITCH - to set ALERT PITCH - to view serial number - to select INTERFACE type (RS232 or IRDA). (Only one of these interfaces may be active at a time.) Press the QUIT softkey to return to Service menu. 4.2.

LOADING PROGRAM

4.2.1. Loading program In order to check the program version, keep the key depressed while turning the pump on. To perform a programming operation, the following is required: - Aitecs 2015 Firmware Upload Utility must be installed and configured on the computer that is being used. - Either RS232 extension cable must be connected between the COM port of the computer and the 9-way ‘D’ connector in the rear of the pump. Select the LOADING PROGRAM and press the OK softkey. The pump is ready for loading the program. Note. When the ERROR: PR02 message (incorrect program CRC) is displayed, the pump also is ready for loading the program.

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Programming sequence: Start Aitecs 2015 Firmware Upload Utility application by clicking on the appropriate icon. Select which COM port is going to be used. Click on (Load configuration Set) in order to load program. key to start the programming operation. Click on Firmware Note. When the ERROR: OTH01 message is displayed set DEFAULT PARAMETERS. Having loaded new program it is necessary to execute full testing (see Section 4.4.1). 4.2.2. Loading Bootstrap In order to perform a programming operation, the following should be in place: - Aitecs 2015 Firmware Upload Utility should be installed and configured on the computer that is being used. - Having opened the pump housing, Bootstrap Loader Unit should be connected to the Electronic board connector JP6 (Bootstrap Loader Unit switch should be in ON position). - RS232 extension cable connected between the COM port of the computer and the 9-way ‘D’ connector in the rear of the pump. Switch on the pump. Press the Reset key on the Bootstrap Loader Unit. The pump is now ready to download a Bootstrap. Programming sequence: Start Aitecs 2015 Firmware Upload Utility application by clicking on the appropriate icon. Select which COM port is going to be used. Click on

(Load configuration Set) in order to load Bootstrap.

Click on Bootloader

key to start the programming operation.

After Bootstrap downloading process is completed, it is necessary to switch Bootstrap Loader Unit switch into OFF position and to press the Reset key. 4.3.

CALIBRATION

Select the CALIBRATION from the Service menu and press the OK softkey. Select item to be calibrated using the softkeys and press the OK softkey. 4.3.1. Syringe size sensor calibration The syringe size detection system stores the characteristics of the syringe clamp assembly, including the travel of the linear potentiometer in non-volatile memory. Equipment:

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Spacer (gauge) SP1 (B8640037-01) or old (B8640022-01); Spacer (gauge) SP2 (B8640037-02) or old (B8640022-02); Spacer (gauge) SP3 (B8640037-03) or old (B8640022-03); Spacer (gauge) SP4 (B8640023).

Select the Syringe size sensor from calibration menu and press the OK softkey. With the syringe clamp at the lowermost position press the OK softkey. One after another insert spacers from 1 to 4, each time closing the syringe clamp and pressing the OK softkey to acknowledge. Finally fix the syringe clamp at the uppermost position and again press the OK softkey. 4.3.2. Pusher position sensor calibration Equipment: - Calibration spacer (gauge) SP1 (B8640037-01) or old (B8640022-01). Select the Pusher position sensor from calibration menu and press the OK softkey. When display reads the message Insert spacer SP1, insert the spacer SP1 and slide the drive pusher to the spacer SP1. Press the OK softkey. Syringe pusher moves backwards and afterwards returns to the spacer SP1. Following question will be indicated on display: Is pusher contacting the spacer? If pusher is not contacting the spacer, press the NO softkey and repeat the calibration. If pusher is contacting the spacer, press the YES softkey. Following message will be indicated on display: Offset XX mm, where XX value shall be (10-13) mm. Press the QUIT softkey to exit. 4.3.3. Force sensor calibration Equipment: -

Digitron pressure meter, model: 2022P (0-1500 mmHg); 50 ml BD PLASTIPAK or 60 ml BD syringe with extension line.

Select the Force sensor from calibration menu and press the OK softkey. The “0 cm Hg >XXXmV<” message should appear on the screen. First step is to be performed without loading syringe. Make sure that plunger retainer lever is released and plunger grippers are in idle position, and pushing surface of the retainer is not in contact with any part of pump or extraneous object. Leave the pump at rest for at least 15 min, then press and release the retainer lever a few times. Make sure that actual output value of the force sensor displayed on the pump screen is (1100±400) mV; if necessary, adjust it by means of the R2 potentiometer on the Drive Unit board. Press the OK softkey, and the “Insert 60 ml BD or 50 ml BD PLASTIPAK” message should appear. Fill syringe with 10-20 ml of water, and fit it to the pump. Connect syringe to the pressure meter by means of the extension line. Locate the pressure meter at the same height as the syringe. Press the RUN softkey and keep it depressed, allowing the transmission to run until the pressure meter reads (148±1.5) cmHg. When approaching the target value, it is recommended to run transmission in short steps, since if you fail to stop transmission timely and target value is

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overridden, calibration procedure must be repeated from the beginning. When pressure is adjusted as required, press the OK softkey, then press retainer lever and move the retainer away from the plunger. Leave the pump at rest for at least 15 min, then press and release the retainer lever a few times and check the values displayed on the pump screen to make sure the following: − difference between actual output value and V1 value is not greater than ±10 mV, otherwise this calibration procedure shall be repeated from the beginning (a few times, if necessary), − difference between V2 and V1 values is within range of 1500-2900 mV. Wrong readings may indicate malfunction of the force sensor or the Drive Unit. Press the QUIT softkey to exit. 4.3.4. Battery calibration Battery calibration cycles the battery through a charge, discharge, re-charge sequence during which the fuel gauge within Battery Unit will be updated with a measurement of the current capacity of the cells. This calibration allows the fuel gauge to monitor accurately the charge in the pack. Over time the estimate of capacity may drift from the actual cell capacity, which generally decreases with time. Recalibration will update the fuel gauge with the measured capacity of the cells. Remove the battery pack lid to ensure a stable pack environment during calibration. It is recommended that the pack is removed from the battery compartment and placed behind the pump. Connect the pump to the mains. Extend the plunger drive arm to the maximum as it will automatically move during the discharge phase. Select the Battery from calibration menu and press the OK softkey. Leave pump in calibration mode for up to 14 hours. The cycle should run passing automatically three phases one by one: • • •

Initial charge phase – 0 to 3 hours Measured discharge phase. Pack is discharged using typical load down to 1.1 V per cell to determine how much charge is available from the pack – up to 10 hours Final charge phase. Pack is fully recharged ready for use. Early in this phase the measured discharge value is transferred to the pack gas gauge to be stored as the new capacity (mAh).

While the calibration cycle is active the battery related information is displayed on the pump screen. At the end of the cycle the screen should show CALIBRATION COMPLETED. Press the QUIT softkey to exit.

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4.4.

TESTING

Select the TESTING from the Service menu and press the OK softkey. Select the item to be tested using the softkeys and press the OK softkey. 4.4.1. Full testing This section provides a complete pump test procedure. During test it is possible to review and modify following parameters: language, date, time, next service date. Follow each stage test and follow the instructions on the display use the QUIT softkey to move to the other test. 4.4.2. Program testing This test is intended to calculate program and bootstrap CRC. Select the Program from testing menu and press the OK softkey. Software version, bootstrap version and calculated CRC values are indicated in the display. Press the QUIT softkey to return to TESTING menu. 4.4.3. Drive sensors test This test enables checking of the following sensors: syringe barrel, plunger grippers, push lever and drive disengaged. Select Drive Sensors from the testing menu and press the OK softkey. Loading and removing the syringe will cause the sensors status to changes indicated on the pump display. Drive engagement sensor can not be activated if nut and lead screw threads come “tooth on tooth”. In such case slide the syringe pusher to another position and repeat the checking. Once complete press the QUIT softkey to return to TESTING menu. 4.4.4. Syringe size sensor test This test is enables checking the operation of syringe size sensor. Select Syringe size sensor from the testing menu and press the OK softkey. Slowly lift the syringe clamp. Check if syringe size sensor value changes (mV and mm). Having finished testing press the QUIT softkey to return to TESTING menu. 4.4.5. Pusher position sensor test This test is enables checking the operation of pusher position sensor. Select Pusher position sensor from the testing menu and press the OK softkey. Insert the spacer SP1and slide the drive pusher to the spacer SP1. Press the OK key. Syringe pusher moves backwards and afterwards returns to the spacer SP1. Pusher position distance (22 ± 0.5)mm should be indicated on the display. Having finished testing press the QUIT softkey to return to TESTING menu. 4.4.6. Motor test This test enables checking of the motor operation. During test no syringe should be installed. Select Motor from the testing menu and press the OK softkey. Having finished testing press the QUIT softkey to return to TESTING menu.

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4.4.7. Display test This test checks that all of the display pixels (240x64) illuminate. Select Display from testing menu and press the OK softkey. Observe “chess-board” structure fields that appear in the display. All the rectangles should be same shaped and evenly filled. Having finished testing press the QUIT softkey to return to TESTING menu. 4.4.8. Nurse call test Equipment: -

Nurse call cable (B6650012); Ohmmeter.

This test checks the nurse call circuit operation. Select Nurse call from testing menu and press the OK softkey. Using a meter check the circuit between the Nurse call contact 3 (com) and contacts 1 (NO), 5 (NC). The contacts should toggle each time the CHANGE softkey is pressed, as indicated on the display. Press the QUIT softkey to return to TESTING menu. 4.4.9. Piezotransducer (speaker)/buzzer test This test checks the piezotransducer (speaker) and buzzer operation. Select Speaker/buzzer from the testing menu and press the OK softkey. Check for the alternating volume and pitches sound from the speaker. Check for the sound from the buzzer. Press the QUIT softkey to return to TESTING menu. 4.4.10. Keyboard test This test enables checking the keypad operation. Select Keyboard from the testing menu and press the OK softkey. You will be prompted to press keys on the display (flashing) in sequence. 4.4.11. LEDs test This test is intended to check the LED operation. Select LEDs from testing menu and press the OK softkey. The following LEDs should activate one after another: ALARM, ALERT, INFUS. and BATTERY. In order to check the operation of BATTERY LED it is necessary to connect the power cable. In order to check the operation of MAINS LED it is necessary to remove and reconnect the power cable. Press the QUIT softkey to return to TESTING menu. 4.4.12. Watch-dog test This test enables checking of the watch-dog circuit operation. Select Watch-Dog from testing menu and press the OK softkey. Initially the watch-dog circuit is applied with an over frequency signal and later with an under frequency signal. When test completed switch off the pump using the OFF key.

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5. RECOMMENDED ROUTINE MAINTENANCE AND TESTING It is recommended that routine maintenance be carried out at least once a year. This should include (see Annex A): - AC Mains / Battery operational checks (section 5.1). - General cleaning and inspection for damage (section 5.2). - Battery test (section 5.3). - Infusion rate check (section 5.4). - Occlusion pressure level check (section 5.5). - Full test (sections 4.4.1-4.4.12). 5.1.

AC MAINS / BATTERY OPERATION CHECK

Switch the pump on and plug pump into the mains. Observe that the MAINS indication LED becomes illuminated. Remover the mains supply and observe that the MAINS LED switches off. Observe that the battery indication LED becomes illuminated as the mains supply is removed. 5.2.

GENERAL CLEANING AND INSPECTION FOR DAMAGE

To ensure that this pump remains in good operating condition, it is important to keep it clean and carry out the routine procedures described below. Servicing should be performed only by a qualified service engineer, with reference to this manual. The following routine maintenance procedures should be carried out as required but at least once per year: Thoroughly clean external surfaces of the pump before and after prolonged periods of storages by wiping a lint-free cloth lightly dampened with warm water and standard disinfectant/detergent solution. Disinfectants known to be corrosive to metals and plastics must not be used. Before cleaning always switch OFF and disconnect from the AC power supply. Never allow liquid to enter the casing and avoid excessive fluid build up on the pump. Do not use aggressive cleaning agents as these may damage the exterior surface of the pump. Do not steam autoclave, ethylene oxide sterilize or immerse this pump in any fluid. Check Labels should be flat and legible. Replace as required Case components must be checked for damage that may affect function, present fluid ingress routes and present a user hazard must be replaced as necessary. Check the operation of the pole clamp screw. Check it is not loose and that the threads are not damaged. Check that it folds away correctly. Inspect the AC power supply inlet and cable for sings of damage.

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5.3.

BATTERY TEST

Perform battery calibration in accordance with 4.3.4. When calibration is completed and the battery is fully charged (at least 2 hours 30 minutes on charge) disconnect the pump from the mains. Load 50 ml BD Plastipak or 60ml BD syringe with the plunger at 60.0 ml position on the syringe barrel scale. Set the 5.0 ml/h rate and start infusion (see the Operator’s Manual for further information on starting the pump). Normally pump should be able to work on battery for about 10 hours. If this time is significantly less battery should be replaced. After completion of the test the pump should be recharged for a minimum of 2 hours 30 minutes. 5.4.

INFUSION RATE CHECK

Equipment: -

stop-watch; graduated glass test-tube (one point equals to 0.1 ml, volume 60ml or more).

Take the BD Plastipak 50 ml or 60 ml BD syringe with extension set and fill it with distilled water up to point of 60ml. Program the following infusion parameters: - VTBI 50 ml; - Rate 50 ml/h. Insert the free end of extension set into the test-tube and start the infusion. Measure infusion time with the stop-watch and read the volume of water delivered into the test-tube. Calculate the infusion rate. It shall be 50ml/h ±1ml/h (±2%). 5.5.

OCCLUSION PRESSURE LEVEL CHECK

Equipment: -

Digitron pressure meter, model: 2022P (0-1500mmHg).

Fill the 50 ml BD Plastipak or 60 ml BD syringe with 20-30 ml of the distilled water and connect it to the pressure meter using the extension set. Switch on the pressure meter and set the max/min pressure recording mode. Set pump occlusion alarm level to L-5 and launch infusion at 5 ml/hr rate (for pump operation details refer to the Operator’s Manual). When pump will stop and indicate OCCLUSION read the maximum pressure recorded by pressure meter. Readings shall be within (63 - 107) cmHg range. If recorded value is outside this range, re-calibrate the force sensor in accordance with 4.3.3 and repeat this test.

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6. TROUBLE-SHOOTING 6.1.

SAFETY WARNINGS

- Use extreme caution when pump whilst it is connected to the AC mains. Hazardous voltages are present at the mains inlet and on the power supply even the pump is switched off. - Disconnect the battery and AC power whenever removing or inserting PCBs or other connectors.

-

This pump contains static-sensitive components. Wherever the ESD symbol appears observe strict precaution for the protection of static-sensitive components when attempting to service and repair the pump. - Always visually inspect the pump, power cord and plug for damage. If the power cord or plug is damaged they should be replaced. - Should further technical assistance be required contact your dealer or manufacturer’s service department. 6.2.

PUMP HAS BEEN DROPPED OR DAMAGED

If the pump is dropped or damaged, the damaged parts should be identified and replaced before any further troubleshooting is carried out. During inspection, careful attention should be paid to the front and rear case halves, for signs of drop damage. Also check the pump drive, syringe pusher, syringe pusher drive, syringe size sensor. 6.3.

PUMP HAS BEEN EXPOSED TO FLUIDS

Excessive fluid spills can lead to fluid ingress into the pump. Even if the fluid dries out, deposits can be left which cause the pump to fail. If fluid ingress is suspected the pump should be inspected internally. Clean and dry out the pump. Take care to ensure dried deposits do not remain on the PCBs or other electrical components. Replace any damaged PCBs or components.

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6.4.

TROUBLE-SHOOTING BY FAULT SYMPTOM

SYMPTOM MAINS LED does not light when plugged into a known good AC outlet. BATTERY LED lights, when pump is powered up. MAINS LED lights when powered from 12VDC.

CHECK Check mains cord Check switching power supply

CORRECTIVE ACTION Replace mains cord. Replace switching power supply if necessary.

MAINS LED does not light when plugged into a known good AC or 12VDC outlet. BATTERY LED lights when pump is powered up.

Check the MAINS LED of the keypad K1 and keypad connection with the Electronic board connector JP12. Check Electronic board.

Replace keypad K1 if necessary.

Replace Electronic board if necessary. Replace fuse F1 with identical one. Replace keypad K1 if necessary.

MAINS LED is light. Pump does not switch on. Pump is unplugged. BATTERY LED does not light when pump is powered up.

Check fuse F1 in the Supply Unit. Check the BATTERY LED of the keypad K1 and keypad connection with the Electronic board connector JP12.

One or more keypad key presses are not accepted. Too high or too low contrast level.

Perform keypad test.

Replace keypad if necessary.

Check contrast setting.

Adjust the contrast as described in Operator’s Manual. Adjust voltage by means of R52, if the problem persists – replace the Electronic board.

Backlight does not operate when pump is powered on.

Aitecs 2015 Service Manual

Check the voltage of the Electronics Board test point TP9. The value should be (-8,0±0,1)V, when contrast is set to level 6. Check backlight setting.

Adjust the backlight as described in Operator’s Manual. Check backlight circuit If necessary replace interconnection on Electronic Electronic board. board Check Display Unit and its If necessary replace Display connection with the Unit. Electronic board connector JP13.

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