Medical Vision Double Pump Service Manual
Medical Vision Double Pump Service Manual
Medical Vision Double Pump Service Manual
Double® Pump
Service Manual
This service manual is for service engineers only.
Issue record
Brief Description
The Double® Pump provides liquid irrigation and flow for endoscopic procedures in one unit through two
individual built-in roller pumps. Both roller pumps are software controlled and automatically manage fluid and
joint pressure based on procedure settings chosen by the user. If needed, both flow and pressure settings can
be individually adjusted. By controlling both inflow and outflow, the Double® Pump accurately regulates pressure
®
and flow in the operative area. The Double Pump will also provide suction when used in conjunction with a
shaver.
The disposable sterile Patient Cassette included sterile Intermediary Tubing, Day Cassette, and Single Tubing
is supplied separately.
Reusable, non-sterile interface cables for compatible shaver systems are available and supplied separately. For
a list of available adapters, please contact your Medical Vision representative.
Installation instructions:
Before each use, inspect the Medical Vision Double® Pump for possible damage. Inspect the power cord and all
cables for wear or cuts.
Connect the Power Cord to the receptacle 15 on the rear panel of the Pump. Connect the other end of the
Power Cord to the electrical outlet. If it is necessary to use a Power Cord other than the one supplied with the
Pump, the alternate Power Cord should comply with appropriate electrical standards and be suitable for hospital
use.
If a shaver is used, connect the relevant shaver interface cable to the shaver interface connector 19 on the rear
panel. Connect the other end to the foot control connector of the shaver as shown in the diagram on page 5. If
the shaver has a hand controlled hand piece, a corresponding shaver interface cable is connected to connector
18.
Attach the Pump Foot Control to the Pump Foot Control Receptacle 11 on the front panel.
Turn the On/Off Switch on the back panel of the Pump to the ‘On’ position. The system should proceed through
a Power On Self-Test routine, and ‘PowerPump’ and software version number should be displayed. During this
sequence, verify that the display and indicator lights are properly working and that the alarm tone is audible. The
If the Double® malfunctions or shows signs of damage, contact Medical Vision Customer Service.
Only the shaver Interface cable shall be used for letting the pump control the shaver.
Closing relays in the pump mimics the activity of the fott control for the shaver console.
During Inflow Only mode, the Double® Pump regulates the pressure using the Day Cassette only. The
Day Cassette is connected to the sterile saline bags.
During Double Pump mode, the Double® Pump regulates flow and pressure using the Day and Patient
Cassettes. The Day Cassette is connected to the sterile saline bags. The Patient Cassette discharges
the liquid from the operating field into a waste collection system.
The Double® Pump has SmartVision™. The SmartVision™ feature will detect blood and / or debris
when it emerges from the joint. It will automatically elevate pressure and flow when blood is detected,
or elevate flow when debris is detected. SmartVision™ can be disabled if desired.
The pump also has an Outflow Tracking feature. This function regulates inflow to the surgery area to
precisely replace liquid removed by the outflow pump. The result is a constant volume of fluid to the
distended joint. This helps to prevent collapse of the joint in cases with a very compliant joint capsule.
Outflow Tracking can be disabled if desired.
Furthermore, the system automatically compensates for liquid resistance in the irrigation system.
FRONT
2. On/Standby button
This button toggles the Double® Pump between On and Standby state. To enter Standby state, press and
hold the button for 2 seconds. If the pump is in Standby state, press the button once to turn the Pump on.
The amber indicator next to the button will illuminate when the Double® Pump is ‘ON’.
6. Display
This Display indicates settings, soft key functions, alarm situations, pressure, and flow values.
8. SmartVision™ button
This button activates/deactivates the SmartVision™ feature. The amber LED is lit when SmartVision™
monitoring is active.
9. Run/Stop button
This button starts and stops the fluid flow and pressure regulation.
REAR
FOOT CONTROL
Cannula Pedal
The blue pedal on the left side of the Foot Control activates the Pump Cannula function.
Rinse Pedal
The red pedal on the right side of the Foot Control activates the Pump Rinse function.
Signal Tones
One short tone: Rinse Mode is activated
Two signal tones: Rinse Mode has been turned off.
Two tones alternating continuously: High pressure warning
A short burst of tones at start up (power on) indicates an automatic zero pressure adjustment if there is no
Day Cassette in place and the front visor is closed.
The software needs to know if the cassettes are positioned correctly so the pump motor may be
started. Both upper and lower clasps must grasp the cassettes, as well as the catch on the lever.
Micro switch sensors are incorporated to ensure correct position of the cassettes. Also, it is
necessary to incorporate a lid protection for the operator to prevent personal injury. The lid must be
in the closed position to enable the pump motor to start. The closed position is confirmed by two hall
element sensors, sensing two magnets embedded in the cover.
Outflow tracking
In yet another situation, the compliance of the body cavity may be very high. As a rule the body
cavity is in this case a shoulder. In the case of rinsing an irrigated pressurized shoulder, there may
be an elevated outflow, but the system would not replace the liquid by maintaining the pressure as
described above. The pressure would nearly persist, but the liquid volume in the body cavity would
drop. Technically speaking, this is a description of tissue hysteresis. In this particular situation, the
viewing field will eventually diminish as the body cavity “caves in”. This happens in spite of the fact
that there is some pressure left. This residual pressure inhibits a relevant inflow to replace the
removed liquid as an effect of the inflow pump pressure regulation. When this particular situation is
the case, the system should decide to elevate the speed of the inflow pump to that of the outflow
pump to compensate for the drawn liquid. This particular functionality overrules the normal pressure
regulation, and is as a matter of definition called “Outflow Tracking“. During Outflow Tracking, the
system must constantly monitor the pressure, as this may not be elevated too high. When the
“Outflow Tracking” function is on, this is indicated with a LED.
Hemoglobin detection:
The hemoglobin detection is achieved by means of an optical method. The degree of blood emerging
from the body cavity is detected by use of an optical detector. The detector is encompassing the fluid
path that leaves the body cavity, and comprises two LED’s. Two photo detectors are detecting the
light intensity from the LED’s that are irradiating the fluid path with light. As known in the art of
detecting hemoglobin, the two sensors can measure a baseline by measuring and storing the light
surrounding the detector first as the light emitting diode is off. At a rapid interval, the LED is turned
on and off at, for instance, a 50 % duty cycle. The light detected when the LED is off represents the
surrounding light from lamps, the sun etc. The light detected when the LED is on additionally
represents the light that has passed through the liquid from the body cavity.
The detector is hemoglobin sensitive by use of a light wavelength that is hemoglobin sensitive. In a
second sensor a different wavelength is used, and this is detecting the baseline optical opacity of the
liquid leaving the body cavity. The comparison of the two signals results in a signal that is most
sensitive to hemoglobin. This comparison is made by subtraction of the two signals from each
detector. This subtraction can be derived by use of a microcontroller process to store the two signals,
and subtracting them (another solution is to store the two detected signal levels by use of sample
and hold circuitry and subtracting the two resulting voltages by use of a differential amplifier).
The result of the hemoglobin measuring is physiologically better expressed as transmission of light
trough a liquid with free hemoglobin.
Debris detection:
“Smog” in the liquid in the surgical site is originating from debris such as that of more or less soft
tissue; more or less shredded by the shaver or other tools. As this material passes the optical
detector at the Patient Cassette, debris is detected and generates signals that are common for both
LED’s.
To achieve this, the optics associated with the LED’s and photo detectors must be designed to
include the whole inner cross section of the liquid.
The system has a distributed structure in which each electronic unit has its own assignment. A CAN
bus provides the communication between circuit boards.
Including power supply actuators (stepper motors) and sensors the whole hardware architecture
could be described as below
Block Diagram
Interconnection cables
Interconnection Diagram
Overall description
The system is composed by a master printed circuit board (MCB) and two slaves printed circuit
boards (DCCB and PCCB).
The DCCBM board encompasses a main microcontroller (DCCB) and a safety microcontroller
(DSM).
The PCCBM board encompasses a main microcontroller (PCCB) and a safety microcontroller
(PASM).
The MCB controls the slaves, giving those commands and set points via CAN bus: Also, it drives the
pinch valves (Cannula Pinch Motor and Shaver Pinch Motor) and implements the human machine
interface managing LCD display, foot-pedals, keyboard, speaker and LED indicators. It also
manages the communication over the RS232 port.
Software features
The MCB software uses CAN bus to send commands and set-points to slaves, and to receive their
status messages.
It calculates and sets Intra articular (joint) pressure and flow values according to the current setting.
It sets the active tool and the detection of hemoglobin and/or debris in the Patient Cassette. This
function is called Auto SmartVision™ and it can be activated or deactivated by user.
It drives three ways pinch valve on the outflow suction, in according with the foot pedal pressed or to
the command from RF Generator:
The MCB software initiates the power-On Test (T0 Test). If this test fails the MCB blocks the system,
cutting-off 24 Volt.
Overall description
This module controls the disposable Day Cassette managing the inflow pressure to the surgical site
using the external three-phase stepper motor (Inflow Motor) connected via a 485 serial interface.
It manages the loading of Day Cassette and implements a P.I.D. algorithm to control the pressure in
Day Cassette, driving the speed of inflow motor pump. The pressure feedback is coming from the
two pressure sensors.
It receives set-point of pressure in mmHg units, or set-points of flow in RPM via CAN bus.
It sends its status over the CAN bus.
Software features
If the Cover-lid is open the pump motors stop. This is detected by two Hall sensors.
If the disposable cassette is not properly fitted, the motors stop. This is detected by a micro switch.
The module reads the status of Day Safety Module via serial connection and compares it to its own
corresponding inputs.
In case of mismatch it cuts-off motor supply.
The microcontroller used is the Freescale MCU-DSP 56F8323.
Overall description
This module interfaces with the Patient Cassette and manages the outflow from the surgical site
controlling an external three-phase stepper motor (Outflow Motor) via a RS 485 serial interface.
It manages the loading of Patient Cassette and checks the presence of hemoglobin and/or debris in
the outflow path of the double pump system: the module transmits its own status to the MCB and
Software features
The DSM microcontroller supervises the DCCB and the Inflow Motor operations.
The main function is to remove the motor supply voltage (24 Volt) when one or more of the following
error condition is met:
excessive motor speed
motor rotation when not supposed to
overpressure
pressure sensor failure
The status of the inputs of DSM is transmitted to the DCCB via a serial line to allow first failure
detection.
The PASM microcontroller supervises the PCCB and the Outflow Motor operations.
The main function is to remove the motor supply when one or more of the following invalid condition
is met:
excessive motor speed
motor rotation occurring when not supposed to
The status of the inputs of PASM is transmitted to the PCCB via a serial line to allow first failure
detection.
Service mode
Setup mode:
Setup mode
Set:
Default pressure
Knee
Shoulder
Small joint
Single
Elevation when Cannula footswitch is pressed
Elevation when Blood detection is triggered
Elevation when Rinse footswitch is pressed or Debris detection is triggered
Max pressure
Knee
Shoulder
Small joint
Single
Elevation when Cannula footswitch is pressed
Elevation when Blood detection is triggered
Elevation when Rinse footswitch is pressed or Debris detection is triggered
In Service Mode an authorized person can select the language for the display, read an event log for
error codes and other alarms and also reset all default values back to the initial (factory) settings.
This is not a user option.
Connections/interface
The Double® Pump has a 25 pin DB rear input connector, and a 4 pin Fischer connector. It informs
the pump if an external shaver is operating by detecting a voltage from the shaver, or a detector
described below, or a relay closure by it. If detected, the pinch valve will switch over to “shaver” and
elevate flow (“Shaver Flow” level).
pin
#
1 FORWARD_Relay_NO clean contact, NO (Forward pedal pressed)
2 REVERSE_Relay_NO clean contact, NO (Reverse pedal pressed)
3 RLY1_NO clean contact, NO (Increase Shaver Speed output)
FORWARD_Relay_C,
4 REVERSE_Relay_C, RLY1_C, RLY2_C all relays common
5 N/C
6 FORWARD_SINK open collector output, max 40V 10 mA (Rout=100 Ohm)
7 REVERSE_SINK open collector output, max 40V 10 mA (Rout=100 Ohm)
8 N/C
9 FORWARD_VOUT 10V voltage output Rout=1.1k Ohm
10 REVERSE_VOUT 10V voltage output Rout=1.1k Ohm
11 RLY2_NO clean contact, NO (Decrease Shaver Speed output)
12 N/C
13 N/C
14 Do not connect
inputs from various Hand piece Adapters (all EM's are shorted
15 EM6 together and brought to the sensing circuitry)
16 EM7 same as above
17 EM8 same as above
18 EM9 same as above
if shorted to DB25_GND, it signals that a bridged DB25 male
19 /PRES_DB25 connector is plugged in (solder bridge between pin 19-20)
common GND for the Open Collector Sink and Voltage outputs
20 DB25_GND and for the /PRESENCE and EM6-EM9 inputs
21 DB25_GND same as above
22 DB25_GND same as above
23 DB25_GND same as above
24 DB25_GND same as above
25 N/C
Interface cables and Shaver hand piece adaptors available are listed separately
Main Control Board Description and Design
Software Description
The software for the Main Control Board of the Pump is embedded in the flash of the microcontroller
and starts executing as soon as the pump is powered on.
The Main Control Board software initiates the power-On Test (T0 Test).
Initialize – initialize ports, interrupts. Run CRC check and RAM test. Run the power-on-test (Pump
P0 Test).
Setup - Allows the user to adjust selected operational parameters that are maintained on the
EEPROM.
Error – This is a non-recoverable state. To release, main power must be turned off.
INITIALIZE
FAULT on/off
MCU
#1
PUMP T0 STAND
FAULT TEST BY
#2
on/off
IDLE
Day-Set,
SETUP Patient-Set
CASSETTE
LOADING
PROCEDURE
SELECTION
PAUSE
run/stop
FAULT
run/stop
RUNNING
on/off,
Day-Set,
Patient-Set
INITIALIZE:
This state is composed by three consecutive phases:
INITIALIZE MCU
This is the first state the instrument encounters after Power On Reset. Here, the software will test
RAM integrity of the MCU, followed by initialization routines such as MCU ports initialization, as well
as internal variable initializations to ready the program to proceed through the states. Also, in this
state, the software will calculate the CRC values of the flash and the EEPROM, comparing them
against the known CRC values.
If an error occurred in this state the software goes to the FAULT #1 state else it goes to PUMP T0
TEST.
FAULT#1
This state is entered if the MCU test failed.
This is a non-recoverable state. It requires the user to reset the power to the instrument in order to
clear any existing faults.
In this state the MDCO output is active.
FAULT#2
This state is entered if the Safety Module test failed.
This is a non-recoverable state. It requires the user to reset the power to the instrument in order to
clear any existing faults.
In this state the MDCO output is active.
IDLE
In IDLE state the software waits the user choice: if he wants to modify system settings, the software
goes to SETUP state, else if he wants select a surgical procedure it goes to DISPOSABLE
LOADING state.
SETUP
The Setup State allows the user to change EEPROM stored parameters.
This state exits to PROCEDURE SELECTION AND DISPOSABLE LOADING state.
DAY-SET and PATIENT-SET buttons enter the PROCEDURE SELECTION AND DISPOSABLE
LOADING state.
ON-OFF button enters the STAND-BY state.
CASSETTE LOADING:
This state allows the user to load (or unload) disposable cassettes.
ON-OFF button enters the STAND-BY state. If at least the Day Cassette is loaded, the
PROCEDURE SELECTION state can be entered pressing a soft key.
PROCEDURE SELECTION:
This state allows the user to select one of the procedures available.
The selection of a procedure loads the pressure and flow set points and makes the transition to the
PAUSE state.
ON-OFF button enters the STAND-BY state.
PAUSE:
In PAUSE state pressure (in the joint) set point is shown. Pressure set point can be adjusted by the
user pressing PRESSURE UP and PRESSURE DOWN buttons.
If the Patient Set is loaded flow set point is also shown. Flow set point can be adjusted by the user
pressing FLOW UP and FLOW DOWN buttons.
SMARTVISION™ button can enable or disable SmartVision™ function.
OUTFLOW button can enable or disable Outflow tracking function.
Priming of Day Cassette can be done by pressing the PRIME soft key.
RUN/STOP button starts the pump and makes the transition to the RUNNING state.
DAY-SET and PATIENT-SET buttons enter the PROCEDURE SELECTION AND DISPOSABLE
LOADING state.
ON-OFF button enters the STAND-BY state.
RUNNING:
In RUNNING state pressure is maintained in the joint according to the current pressure set point.
Estimated joint pressure is shown. Pressure set point can be adjusted by the user pressing
PRESSURE UP and PRESSURE DOWN.
If CANNULA foot pedal is pressed, flow set point is increased until the pedal is released.
If RINSE foot pedal is pressed, flow set point is increased for 2 minutes.
If SHAVER foot pedal is pressed, CANNULA port closes and SHAVER port opens, flow set point is
changed according to a preset value.
RUN/STOP button stops the pump and makes the transition to the PAUSE state.
In RUNNING state Main Control Board sends pressure and flow set points to the DCCB and PCCB
via CAN bus. It receives estimated joint pressure value from the DCCB via CAN bus.
If the COVER is open, the Main Control Board goes into the PROCEDURE SELECTION AND
DISPOSABLE LOADING state, blocking the pumps.
In RUNNING state ON/OFF, DAY SET and PATIENT SET buttons are disabled.
STAND-BY:
In this state the display and all LEDs are off. All buttons except ON/OFF button are disabled.
ON/OFF button makes the pump to go to the IDLE state.
FAULT:
This is a non-recoverable state. It requires the user to reset the power to the instrument in order to
clear any existing faults.
Hardware
The clock frequency for the MCU is 60.0 MHz and is generated by an internal PLL with an external
8.000 MHz Xtal.
The software is able to communicate with a Double® Pump Generator via a RS232 serial
communication port at 9600 bauds, 8 bit data, no parity and 1 stop bit.
The software will interact with additional internal hardware, three unidirectional DC motors in the
pinch valves; activating a cam mechanism. Main Control Board activates the motor through a digital
output. Each pinch valve has two sensors: the first one detects the position of the cam, the second
one detects the position of the pinch. Main Control Board reads the sensors through two digital
inputs.
Main Control Board microcontroller firmware refreshes an external Watchdog circuit (MWD toggle
signal)
The Main Control Board generates a MDCO signal to cut-off MOTOR_SUPPLY in error situation.
Interface
The software interacts with additional internal hardware, namely a 20 character by 4 row
alphanumeric multi language LCD display, a front panel touchpad with 14 buttons and 6 LEDs, and a
speaker. Of the 14 buttons, 4 of the buttons will be soft function buttons, with the function defined by
an adjacent description on the LCD display. 10 of the buttons will be dedicated function with the
following functions:
Standby/On
Functional Requirements
In SETUP state, the following EEPROM stored parameters can be adjusted using the soft keys and
dedicated function buttons.
In SETUP state the following EEPROM stored parameters will be available to choose from and
modify only through a password on the front panel touchpad:
CASSETTE LOADING state manages the loading and unloading of the disposable cassettes. For
each cassette, the LCD indicates whether:
The cassette is properly loaded
The cassette is fitted and the stator has to be closed
The cassette is not properly loaded
In CASSETTE LOADING state, if cover lid is open pressing DAY-SET or PATIENT-SET buttons has
no effect on the pump stators. “CLOSE COVER LID” appears on the LCD.
In CASSETTE LOADING state if at least the Day Cassette is loaded, the PROCEDURE
SELECTION state can be entered pressing a soft key.
In PROCEDURE SELECTION state user can select one of the following procedures using soft keys:
Knee
Shoulder
Hip
Small Joint
In PROCEDURE SELECTION after a procedure has been selected, the relevant set of values have
to be assigned to the pump. They are:
Pressure set point value
Flow set point value
Outflow tracking default state
SmartVision™ default state
They will be displayed LCD in PAUSE and RUNNING state.
The first time a procedure is selected after a power-on reset, relevant values are loaded from
EEPROM.
Next times, if the selected procedure is different from the previously selected, then the values are
loaded from EEPROM, else they are maintained unchanged from the last operation.
In PROCEDURE SELECTION, after a procedure has been selected, the PAUSE state is entered.
In PAUSE state, if PATIENT CASSETTE is loaded, the following buttons are enabled:
DAY-SET, PATIENT-SET: enter CASSETTE LOADING state
In PAUSE and in RUNNING state, if PATIENT CASSETTE is not loaded, the following buttons are
enabled:
DAY-SET, PATIENT-SET: enter CASSETTE LOADING state
ON/OFF: enters STAND-BY state
RUN/STOP: enters RUNNING state
“prime” soft key: starts priming
In PAUSE and in RUNNING state, if PATIENT CASSETTE is not loaded, the following actions have
no effects:
pressing SMARTVISION™ button
pressing OUTFLOW TRACKING button
In PAUSE state if the COVER LID is open “CLOSE COVER LID” appears on the LCD. If PRIMING is
active it is stopped.
In PAUSE state the pressure set point value is showed on LCD. It is adjustable pressing PRESS UP
and PRESS DOWN buttons in the range specified according to the selected joint.
In PAUSE state if PATIENT CASSETTE is loaded, in PAUSE state, the flow set point value is
showed on LCD. It is adjustable pressing FLOW UP and FLOW DOWN buttons in the range
specified according to the selected joint.
In PAUSE mode “PRIME” soft key starts the PRIMING of DAY CASSETTE. While PRIMING is
active, a countdown screen appears.
The speed (flow) of the Inflow pump during priming is 300 ml/min.
Priming pauses if pressure exceeds 400 mmHg.
Pump returns to normal PAUSE screen if it times out or if “BK” soft key is pressed.
In PAUSE and in RUNNING states, the SMARTVISION™ LED is lit on when SmartVision™ function
is enabled.
In PAUSE and in RUNNING states, the OUTFLOW TRACKING LED is lit on when Outflow Tracking
function is enabled.
In RUNNING state, if PATIENT CASSETTE is loaded, the following buttons are enabled:
RUN/STOP: enters PAUSE state
SMARTVISION™: toggles SmartVision™ function
OUTFLOW TRACKING: toggles Outflow tracking function
In RUNNING state, if PATIENT CASSETTE is not loaded, the following buttons are enabled:
RUN/STOP: enters PAUSE state
In RUNNING state, if PATIENT CASSETTE is not loaded, the following actions have no effects:
Pressing SMART/VISION
Pressing OUTFLOW TRACKING
Pressing FLOW UP, FLOW DOWN
In RUNNING state, when a Shaver Controller is connected to the pump, a SHAVER soft key
appears.
In RUNNING state the pressure set point is adjustable pressing PRESS UP and PRESS DOWN
buttons in the range specified according to the selected joint when none of the following function is
active:
Shaver Pedal
Rinse Pedal
Cannula Pedal
SmartVision™ triggered (debris or hemoglobin detected)
The pressure set point is showed on the LCD instead of the pressure measurement for 2 second
after the last button is pressed.
In RUNNING state if PATIENT CASSETTE is loaded the flow set point value is adjustable pressing
FLOW UP and FLOW DOWN buttons in the range specified according to the selected joint when
none of the following function is active:
Shaver Pedal
Rinse Pedal
In RUNNING state pressing the soft key labeled SHAVER, if the shaver is not active, activates the
shaver setup screen.
In RUNNING state, when shaver setup screen is active or when the SHAVER is active, the shaver
suction set point is adjustable pressing FLOW UP and FLOW DOWN buttons in the range specified
for the shaver in the Parameter List and Range Table.
In RUNNING state, if the cover lid is open, the software exits the Running state and enters the
Pause state
In RUNNING state, if one of the mounted cassettes disengages from its place, the software exits the
Running state and enters the Cassette Loading and Procedure Selection state.
Safety Requirements
The Initialization State is entered after a Power On Reset of the Main Control Board. In this state the
Main Control Board software will check the integrity of the stored program by performing a CRC test
of the FLASH space and comparing this calculated value to the CRC value loaded when the MCU
was programmed. If the calculated CRC differs from loaded value the Main Control Board blocks the
system.
The Main Control Board software will check the integrity of the stored data by performing a
Checksum test of the EEPROM space and comparing this calculated value to the CRC value loaded
when the EEPROM was programmed. If the calculated CRC differs from loaded value the Main
Control Board blocks the system.
In the Initialization State the Main Control Board software performs the power-on test (Pump T0
Test) of the MCBM, DCCBM PCCBM using the HW Safety Module. If one of these tests fails the
Main Control Board blocks the system.
The external IC watchdog timer will be activated. The system will be reset in the event that the COP
timer is not periodically strobed by the software.
If no status message from the Patient Cassette Control Board is received for more than 100 ms,
the Main Control Board blocks the system.
Main Control Board stops both pumps if any COVSW sensor is open.
The Main Control Board decodes the “mix code” of pressure sent via CAN bus from Day Cassette
Control Board and compare the result of decoding with the pressure sent.
If the test fails, the Main Control Board blocks the system.
If the Day Cassette Control Board or Patient Cassette Control Board enters into their slave error
state, the Main Control Board blocks the system.
The Main Control Board can block the system removing the Motor Power Supply (24 Volt).
SmartVision™ algorithm
haemoglobin>
haemoglobin_thh
When the SMARTVISION™ algorithm is activated or re-activated, the NORMAL state is entered.
Outflow Tracking
Software Description
The software in this module implements safety controls for the Day Cassette Control Board. Its
functions are to read sensors and communicate the status of those sensors to the main
microcontroller of the Day Cassette Control Board, via serial communication to allow a first failure
detection.
The main function is to remove the motor supply, activating the Safety Link, if one or more of the
following condition is met:
excessive motor speed
motor rotation when not supposed to
overpressure
pressure sensor failure
This software implements functions that could also be implemented in a very simple FPGA. The
software performs safety checks on the CPU hardware, hardware initialization, and variable
initialization immediately after power up. Then the software reads the status of the manufacturing
calibration jumper to decide if it should execute the production software or the manufacturing
calibration hardware. There is no execution path from the manufacturing software to the production
software.
There is a main loop consisting of simple sequential logic. The logic decisions are only one level
deep. Refer to the architecture design chart below.
Decomposition Description
The chart below shows a description of the individual modules in this software and the data
connections between them.
EEPROM
S1 MANAGER
S4
ANALOG
SIGNAL
PROCESSING
UNIT S2
ERROR S6 S7
OUTPUT
CONDITION
MANAGER
S5 DIGITAL DETECTOR
INPUT S3
MANAGER
S9 CONSTANTS
MANAGER
SCI
S10 ROTOR MANAGER S8
PERIOD
OBSERVER S11
Unit description
INITIALIZE
MCU
NORMAL
FAULT CALIBRATION
INITIALIZE:
This is the first state the instrument encounters after Power On Reset. Here, the software will start
initialization routines such as MCU ports initialization, as well as internal variable initializations to
ready the program to proceed through the states.
Also, in this state, the software will calculate the CHECKSUM values of the FLASH comparing it
against the known CHECKSUM value. If the check fails, the software goes into a fault state.
From this state the Day Safety Module software checks the CALIBRATION_PIN for the presence of
the CALIBRATION jumper: if the jumper is present it goes to CALIBRATION state.
If the jumper is not present, the software will calculate the CHECKSUM values of the EEPROM
comparing it against the known CHECKSUM value.
If the check fails, the software goes into a FAULT state otherwise it will go to the NORMAL state.
NORMAL:
In this state the Day Safety Module continuously sends its STATUS to Day Cassette Control Board
and checks:
the Power Supply Voltage of pressure sensors
the Pressure Sensor values
the position of the cover-lid
the presence of the disposable Day Cassette
the speed of the rotor of Inflow Motor
The presence of an error condition binds the Day Safety Module software to go to FAULT state.
FAULT
CALIBRATION
This is a non-recoverable state which requires the user to reset the power to the instrument. In this
state the Day Safety Module stores calibration values for both pressure sensors in EEPROM. In this
state the Safety Link is active.
Calibration is a manufacturing mode. It requires a tool to be activated and is not reachable in normal
operation.
Hardware
The Day Safety Module software will read the pressure in the disposable
Day Cassette through the two pressure sensors.
The values measured are converted by processor’s internal ADC.
The Day Safety Module software will read the period of Inflow Motor rotor
through its Hall sensor.
The Day Safety Module software will read the power supply voltage of
pressure sensors.
The Day Safety Module software will read the position of the cover-lid
The Day Safety Module software activates Safety Link to cut-off the
motor supply
The Day Safety Module software will check the integrity of the stored
program by performing a CHECKSUM test of the FLASH space and
comparing this calculated value to the CHECKSUM value loaded when
the MCU was programmed. If the calculated CHECKSUM differs from
loaded value, the software will go into the FAULT state
The Day Safety Module software communicates its STATUS via serial
communication to Day Cassette Control Board
The Day Safety Module communicates its STATUS every 100 +/- 20 ms.
The ADC count values of the pressure sensors are converted in mmHg
pressure (multiple of 5 mmHg) values using calibration values stored in
EEPROM memory.
IF:
the difference between mmHg pressure values is greater than 40 mmHg
AND
Day Cassette presence sensor communicates that the cassette is
properly fitted,
THEN
the Day Safety module generates the error condition
SENSOR_MISMATCH_ERROR
IF
a mmHg pressure values is greater than 300 mmHg
AND
the Day Cassette is properly fitted,
THEN
the Day Safety Module software generates the error condition
OVERPRESSURE_ERROR
IF
an estimated rotation period, calculated by Hall sensors, is shorter than
150 ms. (corresponding to 400 rpm)
THEN
Day Safety Module generates the error condition OVERSPEED_ERROR
IF
an estimated rotation period, calculated by Hall sensors, is greater than 0
AND
the cover-lid is open
THEN
Day Safety Module generates the error condition
ROTATION_NOT_ALLOWED_ERROR
IF
an estimated rotation period, calculated by Hall sensors, is greater than 0
AND
the Day Cassette is not properly fitted,
THEN
Day Safety Module Software generates the error condition
ROTATION_NOT_ALLOWED_ERROR
IF
one or more of the following error conditions (VDD_ERROR,
OVERSPEED_ERROR,
ROTATION_NOT_ALLOWED_ERROR,
OVERPRESSURE_ERROR,
SENSOR_MISMATCH_ERROR)
is TRUE,
THEN
the Day Safety Module goes to the not recoverable FAULT state in not
over 5 seconds.
When the FAULT state is entered, the Day Safety Module activates
Safety Link
Error Hierarchy
If an error is detected by the Safety Software, this software produces a System Error and stops the
system. The Main Software shows an error code on the LCD display.
Safety Software
ERROR CODE
Error!!!
Main Software
ERROR CODE
CODE DESCRIPTION
0x00 No error
0x01 Day Cassette Control Board generic error
0x02 Day Cassette Control Board does not respond
0x03 Day Cassette Control Board stator sensor error
0x04 Day Cassette Control Board cassette presence sensor error
0x05 Day Cassette Control Board cover sensor error
0x06 Day Cassette Control Board pressure measure error
0x07 Day Cassette Control Board motor error
0x08 Day Cassette Control Board motor timeout error
0x09 Day Cassette Control Board error in loading cassette
0x0A Patient Cassette Control Board generic error
0x0B Patient Cassette Control Board does not respond
0x0C Patient Cassette Control Board stator sensor error
0x0D Patient Cassette Control Board cassette presence sensor error
0x0E Patient Cassette Control Board cover sensor error
0x0F Patient Cassette Control Board motor error
0x10 Patient Cassette Control Board motor timeout error
0x11 Patient Cassette Control Board error in loading cassette
0x12 Pinch Valve generic error
0x13 Pinch Valve shaver error
0x14 Pinch Valve cannula error
0x16 Main Control Board cover sensor mismatch error
0x17 Main Control Board pressure value read is corrupted
0x18 Main Control Board pressure set point echo is corrupted
0x19 Main Control Board T0 test generic error
0x1A Main Control Board T0 test timeout error
0x1B Main Control Board T0 test initial voltage error
0x1C Main Control Board T0 test error on Main Control Board
0x1D Main Control Board T0 test error on Day Cassette Control Board
0x1E Main Control Board T0 test error on Patient Cassette Control Board
0x30 Main Control Board EEPROM error in check memory
0x31 Main Control Board EEPROM error in load data from memory
0x32 Main Control Board EEPROM error in read memory page
0x33 Main Control Board EEPROM error in write memory page
0x34 Main Control Board EEPROM error in read data in memory
0x35 Main Control Board EEPROM error in write data in memory
0x36 Main Control Board EEPROM error in acknowledge wait
CODE DESCRIPTION
0x40 Day Cassette Control Board motor communication error
0x41 Day Cassette Control Board digital sensor unstable
0x42 Day Cassette Control Board pressure sensor mismatch
0x43 Day Cassette Control Board overpressure error
0x44 Day Cassette Control Board error during stator opening
0x45 Day Cassette Control Board error during stator closing
0x46 Day Cassette Control Board EEPROM checksum error
0x47 Day Cassette Control Board cover sensor does not match with Day Safety Module
0x48 Day Cassette Control Board cassette presence sensor does not match with Day
Safety Module
0x49 Day Cassette Control Board right pressure sensor does not match with Day Safety
Module
0x4A Day Cassette Control Board left pressure sensor does not match with Day Safety
CODE DESCRIPTION
0x70 Day Safety Module flash checksum error
0x71 Day Safety Module EEPROM checksum error
0x72 Day Safety Module pressure sensor error mismatch
0x73 Day Safety Module overpressure error
0x74 Day Safety Module rotor over speed error
0x75 Day Safety Module rotation not allowed with cover open
0x76 Day Safety Module rotation not allowed without cassette
0x77 Day Safety Module pressure sensor power supply error
0x78 Day Safety Module generic error in calibration
0x79 Day Safety Module error in calibration during point 1
0x7A Day Safety Module error in calibration during point 2
0x7B Day Safety Module error in calibration saving data
0x7C Day Safety Module error in calibration idle
CODE DESCRIPTION
0xA0 Patient Cassette Control Board error in motor communication
0xA1 Patient Cassette Control Board digital sensor unstable
0xA2 Patient Cassette Control Board error during stator opening
0xA3 Patient Cassette Control Board error during stator closing
0xA4 Patient Cassette Control Board cover sensor does not match with Patient Safety
Module
0xA5 Patient Cassette Control Board cassette presence sensor does not match with
Patient Safety Module
0xA6 Patient Cassette Control Board timeout error in communication with Patient Safety
Module
0xA7 Patient Cassette Control Board CANBUS timeout error
0xA8 Patient Cassette Control Board motor initialization error
CODE DESCRIPTION
0xD0 Patient Safety Module flash checksum error
0xD1 Patient Safety Module EEPROM checksum error
0xD2 Patient Safety Module rotor over speed error
0xD3 Patient Safety Module rotation detected with cover open
0xD4 Patient Safety Module rotation not allowed without cassette
In the error page press together the “SMARTVISION™” button and the “OUTFLOWTRACKING”
button.
Now you have entered the Setup Menu where you can find more information about the error
condition.
In this menu press “DAY-SET” button to enter the Safety Module Service Menu.
Setup
press Setup Service Mode
press ^ (upwards arrow) Passcode Required
press OK to select Service Mode: *****
<
press the following sequence to gain access: >Set Time
Char_1 Char_2 Char_3 Char_4 Char_5 Set Date
Flow+ Pressure+ Pressure- Pressure- Flow- Reset Data Log
OK
press OK to access the Set Time function: S Set Time
24h 18:31
--
<
two "underscore" characters select the values that are going to
be modified.
Flow + increments the value
Flow - decrements the value
Pressure + shifts right the cursor
Pressure - shifts left the cursor
S saves the change
< goes back to the previous menu
when done with the Set Time menu, exit with "<" and enter the S Set Date
Set Date menu. D:08 M:01 Y:2009
Proceed as before for changing the Date. --
Press "S" only if you want to change the values, otherwise exit <
again with "<"
Troubleshooting
Some of the about 80 error codes listed before point to a problem that could be solved in the
Operating Room. Here is a list of those codes, along with the required action to restore full pump
functionality.
If a pressure mismatch of more than 40 mmHg persists between the sensor pair for
more than 5s, an irreversible error is generated with the following error page:
Sometimes the error page may be slightly different, but the relevant ERROR CODE:
error codes are: 01070A0F4072A0000000
01 and 72 Read operate. man.
The 20-character error code is to be read as 10 pairs of 2 And switch off
characters each.
If the pump has been turned off and you wish to check the pressure sensors, please do the following:
Setup
If changing the Day cassette doesn't solve the problem, perform a static sensor test as follows:
switch on the pump, pressurize the Day cassette with a syringe and read the values as explained in
Table 2 above.
Make 3 tests: P=0, P=50 mmHg and P=250 mmHg
High Pressure Warning: Acoustic alarm sounds. To mute for one minute:
Press soft key M.
Pressure in surgical site “HIGH PRESSURE WARNING”
exceeds 250 mmHg appears in the display. Check that flow to and
from the joint is not
A” *” symbol indicates if the obstructed. Check the
alarm is muted. condition of the joint.
Internal Hardware Error Pump stops and a continuous Note the error code, turn
acoustic alarm sounds. off pump, and contact
Customer Service.
ERROR CODE XXXXXXXX
Upgrades
Software upgrades are performed by Medical Vision Engineers. This is made via the RS 232 serial
connector (13) at the rear.
Equipment Disposal
The Medical Vision Double® Pump contains electronic printed circuit board assemblies and should
not be disposed in any waste container. It should be disposed of in accordance with any applicable
national or institutional policies relating to obsolete electronic equipment. Contact Medical Vision
Service Centre for return of the Double® Pump for proper disposal. Discard the cassette in
accordance with hospital regulations for potentially contaminated items. The Double® Pump does not
contain NiCd or lead batteries.
8
1
11
2
14 3
6 1 1
1
5
1
1
1
10
1
13 11
2 1 2
1
7
1
4
1 9
1
Mod. n° -
Date -
Signature -
Revision A B C D E F G H
Via Marconi, 2
Description
41036 Medolla (MO) QUANTUM PUMP
ITALY
Code Rev.
The copyright of this drawing is reserved by LEAN s.r.l. 0145040 A1
List of parts
Repairs
NOTE:
If a new MCB board has DEFAULT parameters loaded into EEPROM. Remember to reload the
personalized JOINT and TOOLS parameters before returning the pump (alternatively inform the
user).
Replacement parts can be ordered from the Service Center. Contact details are on the last page.
Tools/
Step Description Image
Note
Use a spacious
surface for
3.1 servicing the
Power™ Pump
PH1
Unscrew the 4 side
Phillips
3.3 screws that hold
screw-
the top cover
driver
Disconnect the
3.7 pinch valve
connectors.
Pay attention
Remove the RFID to the RFID
antenna antenna
connectors connectors
(the 2 small metal (the small
connectors at the metal boxes
3.8 end of the brown
ending the
brown cables).
cables) When re-
Mark the right inserting them,
connector with a respect their
color dot or similar orientation as
shown in the
picture
Use a pair
of long-
nose pliers
or a
screwdrive
r blade to
retract the
board
holder's
Unlatch the 4 white
latching
board holders and
pin
3.11 remove the Main
Control Board by
Four
gently lifting it up
pieces of
4mm ID
stiff tubing
will help
retracting
all the
latching
pins at the
same time.
Be careful to align
properly the thin
3.13
mylar cable
connectors.
When
reconnecting the
RFID antenna
cables, make sure
you don't swap the
right and the left
connectors.
3.22
The brown cable
should come out of
the lower right
corner of the metal
connector, as
shown in the
picture
Push connector
4.1 J19 (RS232) all
the way down
The space is
limited, therefore it
may take some
cable handling
before a satisfying
arrangement is
achieved. Be sure
4.20 every connector is
completely mated
to its counterpart.
Mylar connectors
(depicted in step
3.14) should be
connected last
Procedure
1. Verify that labels are intact and that the pump unit is clean. In particular, check the cavities for the
cassettes, the optical components and the pressure transducers.
2. Inspect pump for obvious damages, such as cracked casing or front cover, replace broken parts.
3. Inspect power inlet and power cord.
4. Turn on main switch, press on/stand by and the Software version will show in the display during the
Startup self‐test, record the software version. Check that the pump is updated with the latest SW.
5. Review Error log, Troubleshoot if errors are registered.
6. Verify that date and time is correct. Correct if wrong.
7. Verify pressure arm movement. Make sure the pressure arm moves to both end positions as the
Day Cassette and Patient Cassette are pushed.
8. Inspect sensors for Cassette positioning.
Verify Pressure
a) Turn on main switch and press on/ stand by with no Day Cassette mounted
b) Set up the system with a Day Cassette according to the user manual for single use.
c) Connect a manometer and a syringe to the outflow of the day cassette using a T connector
and correct tubing.
d) Press day cassette
9. e) Choose joint, for example shoulder
f) Start the pump
g) Loose the syringe a little bit to get outflow from the day cassette, do not loosen too much
=> low pressure warning
h) Apply pressure to 100 mmHg, record the value in the display, the value should be in the
tolerance of +‐15 mmHg.
i) Apply a pressure of 200 mmHg, record the value in the display, the value should be in the
tolerance of +‐15 mmHg.
Verify Alarms
a) Turn on the pump
b) Run the pump with a Day Cassette mounted and no clamp or syringe connected to the
right tubing and no manometer connected to the left tubing. Make sure the pump unit
does not build a pressure. The pump should give an alarm after about 5s for “Low pressure
warning”.
10. c) Apply a pressure of 250 mmHg by using a syringe and a manometer connected to the right
tubing of the Day Cassette (three way connection). The pump should give an alarm for
“High pressure warning”.
d) Press the syringe and apply a pressure higher than 300 mmHg. The pump must stop and
give an alarm after approximately 5s.
Conclusion
MAINTENANCE ACTIVITIES COMPLETED
TEST PASSED
TEST FAILED
NOTES:
Service Identification
Operator Name
Operator Organization
Date
Location
PUMP DIMENSIONS
Weight 17,5 kg (48.5 lbs.)
Height (front panel closed 18.1 cm (7.1 inches)
Width 47.1 cm (18.5 inches)
Length 39.7 cm (15.5 inches)
POWER CORD
Length 3.3 m (10 ft.)
FOOT CONTROL
Foot Control Cable Length 4.7 m (15 ft.)
Symbols
Serial Number
Product Code
Electrical Power
Manufactured by:
Medical Vision® AB
Hästholmsvägen 32
SE-131 30 NACKA
SWEDEN
+46(0)8 452 49 50
www.medicalvision.se