Medical Vision Double Pump Service Manual

Medical Vision®
Double® Pump
Service Manual
This service manual is for service engineers only.
This is a confidential document, and may not be copied or

distributed by any means.
Version 1.0. This corresponds to Software version DP_2_4_0.
Issue record
Date Version Software version

May 2008 0.1 080404A
Aug 2008 0.11 1.1.0
Aug 2008 0.12 1.1.0
Aug 2008 0.13 1.1.0
June 2012 1.0 DP_2_4_0
Table of contents
Responsibilities and authorization ............................................................................................... 5

Hazards related to servicing ............................................................................................................. 5
Brief Description ............................................................................................................................ 5
Installation instructions: .................................................................................................................... 5
Unpacking, Assembly, and System Check .................................................................................. 5
Assembly and System Check ....................................................................................................... 5
System Overview and Shaver interfacing.................................................................................... 7
Principle of Operation .................................................................................................................... 8
Controls, Indicators, and Alarms .................................................................................................. 9
Controls & Indicators ........................................................................................................................ 9
Signal Tones................................................................................................................................... 11
System Care .................................................................................................................................. 12
System Environmental Requirements ....................................................................................... 12
Overall function description........................................................................................................ 13
The Day Cassette ........................................................................................................................... 13
The Patient Cassette ...................................................................................................................... 13
Accurate control of pressure in the joint: .................................................................................. 13
Compensation for resistance.......................................................................................................... 13
Hydraulic impedance ...................................................................................................................... 14
Outflow tracking .............................................................................................................................. 14
Hemoglobin detection: ................................................................................................................ 14
Debris detection: .......................................................................................................................... 14
SmartVision™ ............................................................................................................................... 15
Architectural Overview ................................................................................................................ 16
Electronic Hardware Description .................................................................................................... 16
Block Diagram ................................................................................................................................ 16
Interconnection cables ................................................................................................................... 16
Interconnection Diagram ................................................................................................................ 17
Overall description ....................................................................................................................... 17
Software features ......................................................................................................................... 17
Day Control Board ........................................................................................................................ 18
Overall description .......................................................................................................................... 18
Software features ........................................................................................................................... 18
Patient Control Board .................................................................................................................. 18
Overall description ....................................................................................................................... 18
Software features ........................................................................................................................... 19
Day Safety Module ......................................................................................................................... 19
Patient Safety Module .................................................................................................................. 19
Service mode ................................................................................................................................ 19
Setup mode: .................................................................................................................................. 20
Setup mode ................................................................................................................................... 20
Connections/interface .................................................................................................................. 20
Rear Panel connector DB25 pinout ................................................................................................ 21
L-2012-006-01 Service Manual Double Pump 3

Shaver Interface Box ...................................................................................................................... 22
Main Control Board Description and Design............................................................................. 23
Software Description ...................................................................................................................... 23
State Chart Description .................................................................................................................. 23
Hardware ........................................................................................................................................ 26
Interface.......................................................................................................................................... 26
Functional Requirements ............................................................................................................... 27
Safety Requirements ...................................................................................................................... 32
SmartVision™ algorithm ................................................................................................................. 33
Outflow Tracking ............................................................................................................................ 34
Day Safety Module (DSM) ............................................................................................................ 34
Software Description ...................................................................................................................... 34
Architecture Design Chart ........................................................................................................... 35
Decomposition Description............................................................................................................. 35
Unit description ............................................................................................................................... 35
Signal description ........................................................................................................................... 36
Operational Sequence Diagrams ................................................................................................... 37
State Chart Description .................................................................................................................. 38
Software Requirements Specification ............................................................................................ 39
Hardware ........................................................................................................................................ 39
Software Performance and Functional Requirements ................................................................... 39
Error Hierarchy ............................................................................................................................. 41
Main Software Error Code .............................................................................................................. 42
Safety Software Error Code ........................................................................................................... 43
How to set the System Clock ...................................................................................................... 45
Troubleshooting ........................................................................................................................... 45
PRESSURE MISMATCH ERROR ................................................................................................. 46
Alarms ........................................................................................................................................... 49
Upgrades ........................................................................................................................................ 49
Equipment Disposal ....................................................................................................................... 49
Surface Cleaning & Disinfection of Pump and Foot Control .......................................................... 49
Assembly overview ...................................................................................................................... 51
Assembly drawing ........................................................................................................................ 52
Drawings and List of parts .............................................................................................................. 52
List of parts ..................................................................................................................................... 52
Repairs .......................................................................................................................................... 56
Disassembling and reassembling: ............................................................................................. 57
Preventive maintenance .............................................................................................................. 64
Procedure ....................................................................................................................................... 64
Preventive maintenance Report form ............................................................................................. 66
Comments ..................................................................................................................................... 67
Conclusion .................................................................................................................................... 67
Service Identification ................................................................................................................... 67
Copy filed to Distributor / Manufacturer ------------------------------- ............................................. 67
Technical Specifications ................................................................................................................. 68
Pump Classification and Safety Verification ............................................................................. 69
Classification ................................................................................................................................ 69
Symbols......................................................................................................................................... 69

Responsibilities and authorization
Service of the Double® Pump may only be performed by Authorized Service Engineers. Authorization is
accomplished by attending a Medical Vision Service seminar to acquire a certificate. The certificate is issued
after that the engineer has made evident that the training is understood.
Hazards related to servicing

Power must be disconnected before dismantling and cleaning. High voltages may be present inside the power
supply even after disconnection.
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 Double® Pump system consists of the following components:

Double® Pump Unit
a reusable, non-sterile Foot Control
a reusable, non-sterile Power Cord
a disposable, sterile Patient Cassette and sterile Intermediary Tubing inclusive (sold separately)
a disposable, sterile Day Cassette (sold separately)
a disposable, sterile Single Tubing (sold separately)
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:
Unpacking, Assembly, and System Check

Assembly and System Check
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

Display should show ‘START’ and ‘setup’ options associated with the Soft Keys 5. If an error code appears
instead, the pump may not be used. Contact Medical Vision Service Centre, and report the error code number.
If the Double® malfunctions or shows signs of damage, contact Medical Vision Customer Service.

System Overview and Shaver interfacing.
Only the shaver Interface box shall be used for letting the shaver signal to the pump that the
shaver is active. The Shaver interface box comprises a voltage detector that senses the
voltage to the motor in the shaver hand piece; wether DC or AC.
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.
1. Double® Pump 4. Shaver

2. Power Cord 5. Shaver hand piece
3. Double® Pump Foot Control 6. Shaver Interface Box
3a. Shaver Left Pedal. 7. Cable for Shaver Interface Box
3b. Shaver Right Pedal. 8. Shaver Interface Cable
3c. Cannula Pedal
3d. Rinse Pedal

Principle of Operation
The Double® Pump can operate in two modes:
1) Inflow Only
2) Double Pump
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.

Controls, Indicators, and Alarms
Controls & Indicators

The Double® Pump incorporates the following controls and indicators:
FRONT
1. Day Cassette button

This button loads and unloads the Day Cassette pressure arm.
The green indicator beside the button indicates the following status:
Off when the Day Cassette is not positioned in the pump (pressure arm up)
Flashing when the Day Cassette is correctly positioned in the pump (pressure arm up)
Flashing if the Day Cassette is incorrectly positioned in the pump (pressure arm down)
On when the Day Cassette is correctly loaded (pressure arm down)
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’.
3. Outflow Tracking button

This button activates/deactivates the Outflow Tracking feature. The amber LED is lit when Outflow
Tracking is active.
4. Pressure increase/decrease buttons

These buttons adjust the pressure setting controlled by the pump.
5. Soft Keys (4)

The function of these buttons is indicated by the adjacent text in the Display. The functions vary as the
Display text changes.
6. Display
This Display indicates settings, soft key functions, alarm situations, pressure, and flow values.

7. Flow/ increase/decrease buttons
These buttons adjust the Flow setting controlled by the pump. The Flow adjustment is only available if a
Patient Cassette is being used.
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.
10. Patient Cassette button

This button loads and unloads the Patient Cassette pressure arm.
The green indicator beside the button indicates the following status:
Off when the Day Cassette is not positioned in the pump (pressure arm up)
Flashing when the Day Cassette is correctly positioned in the pump (pressure arm up)
Flashing if the Day Cassette is incorrectly positioned in the pump (pressure arm down)
On when the Day Cassette is correctly loaded (pressure arm down)
11. Pump Foot Control Receptacle

The Pump Foot Control plugs into this receptacle located on the front of the Pump.
REAR
12. On/Off switch

This switch turns the AC power on and off. Note that the pump may be entered into standby state by
pressing the On/Standby button located on the front panel.
13. Serial Communication Port

This port is for software upgrading only, and is dormant during any pump operation..
14. Tone Volume Control

The Tone Volume Control regulates tone volume. To increase volume, turn the knob clockwise. To reduce
volume, turn the knob counterclockwise.
15. Power Cord Receptacle/Fuse Holder

The Pump Power Cord plugs into this receptacle. The fuse holder is located between the power cord
receptacle and the On/Off switch.

16. Equipotential Ground Conductor
This conductor is used to bond the equipment to earth ground.
17. Shaver Connection

This receptacle is for Shaver Interface Boxes.
18. Shaver Connection

This receptacle is for Shaver Interface Cables.
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.

System Care
System Environmental Requirements
The Double® Pump may be safely stored and transported at an ambient temperature range of -40°C
(-40°F) to +70°C (+158°F), relative humidity between 10 and 85%, and atmospheric pressure of 500
hPa (7.2 psi) to 1060 hPa (15.3 psi).
The Double® Pump may be safely operated at an ambient temperature range of 10°C (65°F) to 40°C
(104°F), relative humidity between 10 and 85%, and atmospheric pressure of 700 hPa (10.1 psi) to
1060 hPa (15.3 psi).

Overall function description
Cassette position sensing
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.
The Day Cassette

The Day Cassette is mounted first. The output of the Day Cassette incorporates two thin and highly
flexible membranes by the pressurized section of the Day Cassette. The membranes are pressing
against two pressure transducers mounted in the front panel of the instrument housing. In other
words, the system can measure the pressure in the Day cassette. This is defined as cassette
pressure. A mechanism regulating the inflow pressure delivered from the Day Cassette is formed:
Software selection of cassette pressure (NOT in the surgical site) is set and compared by software
with the pressure measured.
Two pressure transducers are used for the purpose of integrity of the pressure control. Both pressure
transducers monitor the pressure, and a difference indicates a transducer or hardware error, or
possibly error in the mounting of the cassette or cassette error. This difference is established to 40
mmHg. Error inhibits the use of the system and generates an error code.
The Patient Cassette

The Patient Cassette arrangement is a robust solution to affixing the tubing from the shaver/cannula
in an optical path. This optical path is the core of the SmartVision™ patented technology, and
involves a mirror in the patient cassette to double the optical path, and thus doubles the sensitivity to
detect blood and/or debris coming from the surgical site and is aspirated into the cuvette portion of
the patient cassette.
The Patient cassette has an air trap for degassing the liquid. This makes it possible to exclude the
disturbance to the measurements caused by air bubbles.
The pump is not dependent of having the Patient Cassette fitted to be started. In other words, the
startup procedure can be to fit the Day Cassette, prime the cassette (and endoscope). This setup is
Inflow only, or Single. For Double operation, the Patient Cassette can be fitted thereafter.
Accurate control of pressure in the joint:

The pressurized liquid is fed via the Day cassette and tubing to the arthroscope for irrigation of the
surgical site. The hydraulic resistance in the arthroscope is the most contributing to the total pressure
drop.
Compensation for resistance

Due to resistance in the liquid pathway there is a loss of pressure. This pressure loss subsists all the
way from the inflow pump to the body cavity, and varies by various components forming the liquid
path. The pressure loss is higher the smaller the lumen of the liquid pathway is, and higher the flow
is. Resistance is not linear in respect of flow. Flow turbulence in the irrigation system causes
unlinearities. The derived resistance can be expressed as:
Resistance = Ppump – Pcavity

Flow
The pressure control algorithm in the pump makes this compensation when calculating a target
pressure in the Day cassette to accomplish a set pressure in the joint.

Hydraulic impedance
Above-mentioned flow/pressure relationship is discussed with a constant flow in mind. If one should
take not only a constant static flow in account but also the change in flow, the flow restriction in the
tubing and instrumentation is described as impedance. The reactive component has a restrictive
effect on acceleration of the liquid in the tubing and instrumentation. The consequence is that an
initiated change of pressure results in a change of flow after some time. At a nominal pressure and
nominal flow for an endoscopy system as described, this flow change is approximately 2 seconds.
For utmost control of pressure in the body cavity, this reactance is taken into account. The decision
to increase flow is as a rule fairly urgent. Thus, the pressure that accelerates the liquid has to initially
be even higher than the designated pressure by the inflow pump to accelerate the liquid. This can be
defined as a pressure overshoot. As the flow is to be increased, the reactive component is
compensated for by this pressure overshoot. The algorithm monitors that the joint is not over
pressurized.
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.

SmartVision™
The signals from hemoglobin and debris detection can automatically increase flow to quickly
reassess clear view at the surgical site. Detected debris increases flow, and detected hemoglobin
increases pressure and flow for a predetermined time. Increasing pressure reduces the bleeding.
When blood or debris is detected, that is – when a predetermined level is passed – the flow should
elevate from the nominal 150 ml/min to 300 ml/min. Such increase is in steps to achieve the target of
a clear viewing filed for the surgeon. This persists as long as blood or debris is detected. If the time
surpasses a predetermined “bleeding time” or if the signal level from the optical detector remains
high, the flow will increase further, but is reduced again when the blood. This functionality we call
Auto SmartVision™.

Architectural Overview
Electronic Hardware Description
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
Part No Interconnection cables

0211402 CABLE KIT, ALL INCLUSIVE
0176800 Cable MCB - 24V motor DAY
0176810 Cable MCB - 24V motor PATIENT
0177500 Cable DCCB - RS485 motor
0177510 Cable PCCB - RS485 motor
0188300 Cable DCCB - sensor Hall
0188400 Cable PCCB - sensor Hall
0188510 Cable DCCB - Pressure transducers
0188600 Cable CAN-bus SHORT
0188700 Cable POWER SHORT

0188800 Cable POWER, LONG
0188900 Cable MCB - speaker e potentiometer volume
0189010 Cable MCB - footswitch interface
0189300 Cable EMI FILTERED SOCKET - POWER SUPPLY RGM
0189400 Cable MCB - RGM POWER SUPPLY
0189600 Cable CAN-bus LONG
0190000 Cable flat MCB - LCD 2,54 PITCH
0206800 Cable PCCB - Optical Box
0211300 Cable lid grounding
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 software for the MCB of the Double® Pump is embedded in the flash memory of the
microcontroller and starts executing as soon as the instrument is powered on.
The MCB software uses CAN bus to send commands and set-points to slaves, and to receive their
status messages.
It implements the human machine interface:

Customized Keyboard
Alphanumeric LCD blue back lighted 20x4
LED lights
Audible signals
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 stores the preset values for several surgical procedures.
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.
The microcontroller used is the Freescale MCU-DSP 56F8347.
Day Control Board
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.
Patient Control Board
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

receives the actuation commands to move the Outflow Motor. The motion and the speed of the rotor
are sensed using one Hall sensor. Magnets are fitted in the pump head.
The PCCB board is connected to the others modules via CAN bus interface, to receive commands
and set point and to send status.
Software features
If the Cover-lid is open then the motor must be stopped.

If the disposable cassette is not properly fitted, the motor is stopped.
The module reads the status of Patient Safety Module via serial connection and compares it to its
own corresponding inputs.
In case of mismatch it cuts-off motor supply.
Day Safety Module
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 microcontroller used is the Microchip PIC 16F688.
Patient Safety Module
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:
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.
The microcontroller used is the Microchip PIC 16F688.
Service mode
To enter the service mode – from the Start menu press

Service Mode 1 Pass code
Char_1 Char_2 Char_3 Char_4 Char_5
Flow+ Pressure+ Pressure- Pressure- Flow-
In Service mode, the following settings can be made:

 The display language can be selected

 The pressure increase in mmHg when blood detected by SmartVision™ can be adjusted
(factory setting is 50 mmHg)
 The flow increase in % when debris is detected by SmartVision™ can be adjusted (factory
setting is 50 %)
 Flow increase in % with Cannula pedal can be set (factory setting is 50 %)
 Pressure and flow increase in % with Rinse pedal can be set (factory setting is 50 %)
 All values and settings can be reset to factory settings
 System time and date can be set (future function)
Setup mode:
Power on the system.

After start-up - press “Outflow Tracking” and “SmartVision™” buttons simultaneously.
Setup mode functions:

Read CRC values (Press “Show”)
read hex values from pressure transducer A/D (See Para DSM calibration),
read cassette pressure from both transducers (P1 and P2).
Calibrate pressure measurement
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).

Rear Panel connector DB25 pinout NOTES
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
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
25 N/C

Shaver Interface Box
To know if a shaver is activated, it is possible to detect the output voltage from the shaver power
supply/driver electronics to the shaver hand piece. This voltage may be DC or three phases of AC,
up to 50V. A detector comprises a box with male and female connectors to fit on the front panel of
the shaver driver. There is one interface box version for every shaver/ shaver driver model as the
connectors are different between shaver models. The connectors for the hand pieces are the only
differences between the models of these boxes. The voltage detection provides full isolation between
pump and shaver setup. The box is connected to the Shaver Hand piece interface connector.
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).
The Main PCB microcontroller is the Freescale MCU-DSP 56F8347.
The software has the following main states:
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.
Cassette Loading and Procedure Selection - Loading or unloading of disposable cassettes,

selection of procedure type.
Running - Fluid is pumped through disposable cassettes.
Error – This is a non-recoverable state. To release, main power must be turned off.
State Chart Description

POWER ON
RESET
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.

PUMP T0 TEST
The Main Control Board initiates the power-On Test (T0 Test) of the MCBM, DCCBM, PCCBM and
of the HW Safety Module. If this test fails the Main Control Board blocks the system and goes to the
FAULT#2 state.
If an error occurred in this state the software goes to the FAULT #2 state else it goes to IDLE state.
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.
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.
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.
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.
When OUTFLOW TRACKING is enabled pressure is …

If the Patient Set is loaded, an output saline flow is maintained according to the current flow set
point. 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.
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:
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 microcontroller will has a 512 kbit serial I2C EEPROM.
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

Day-Set Load and Unload
Patient-Set Load and Unload
Pressure Increase
Pressure Decrease
Flow or Suction Increase
Flow or Suction Decrease
Outflow Tracking On/Off
SmartVision™ On/Off
Pump Run/Stop
Functional Requirements
If all initialization tests succeed, pump enters IDLE state.
In IDLE state pump motors are stopped.

The following actions have no effects:
Pressing RUN/STOP
Pressing SMART/VISION
Pressing OUTFLOW TRACKING
Pressing PRESSURE UP, PRESSURE DOWN
Pressing FLOW UP, FLOW DOWN
Opening and Closing the LID
Loading and Unloading Cassettes
Pressing Foot pedals (Cannula, Rinse)
Shaver
Pressing SHAVER foot pedals
Connecting and disconnecting foot pedal cable
Powering On and Powering Off Shaver Controller
In IDLE state the following buttons are enabled:

DAY-SET, PATIENT-SET: enter CASSETTE LOADING state
ON/OFF: enters STAND-BY state
Soft key buttons: enter CASSETTE LOADING state, enter SETUP state
In SETUP state pump motors are stopped.

Pressing RUN/STOP
Loading and Unloading Cassettes
In SETUP state the following buttons are enabled:

In SETUP state, the following EEPROM stored parameters can be adjusted using the soft keys and
dedicated function buttons.
Parameter List and Range Table

Parameter Default Range
Knee Flow 100 ml/min 0-600 ml/min
Knee Pressure 70 mmHg 10-200 mmHg

Knee SmartVision™ On On or Off
Knee Outflow Tracking Off On or Off
Shoulder Flow 130 ml/min 0-600 ml/min
Shoulder Pressure 100 mmHg 10-200 mmHg
Shoulder SmartVision™ On On or Off
Shoulder Outflow Tracking Off On or Off
Hip Flow 130 ml/min 0-600 ml/min
Hip Pressure 130 mmHg 10- 200 mmHg
Hip SmartVision™ On On or Off
Hip Outflow Tracking Off On or Off
Small Joint Flow 50 ml/min 0-600 ml/min
Small Joint Pressure 70 mmHg 10-200 mmHg
Small Joint Outflow Tracking On On or Off
Small Joint SmartVision™ Off On or Off
Shaver Suction 500 200-600 ml/min
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:
Parameter List and Range Table

Parameter Default Range
Cannula Pedal Flow Increase 50% 10%-100%
Rinse Pedal Pressure Increase 50% 10%-100%
Rinse Pedal Flow Increase 50% 10%-100%
SmartVision™ Debris Detection Flow Increase 50% 0%-100%
SmartVision™ Hemoglobin Detection Flow 50% 10%-100%
Increase
SmartVision™ Hemoglobin Detection Pressure 50 mmHg 10 mmHg -100 mmHg
Increase
Language English English
French
Italian
German
Spanish
Portuguese
Dutch
Danish
Norwegian
Swedish
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 the following actions have no effects:

Pressing RUN/STOP
Activating and De-activating Shaver

In CASSETTE LOADING state
ON/OFF button enters STAND-BY state
A soft key is available to go to the IDLE state
In CASSETTE LOADING state, if cover lid is closed

Pressing DAY-SET button opens and closes the Day Pump Stator
Pressing PATIENT-SET button opens and closes the Patient Pump Stator.
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 pump motors are stopped.

Pressing RUN/STOP
Pressing PRESSURE UP, PRESSURE DOWN
Shaver
In PROCEDURE SELECTION state the following buttons are enabled:

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 PATIENT motor is always stopped.

Activating and De-activating Shaver
In PAUSE state, if PATIENT CASSETTE is loaded, the following buttons are enabled:

RUN/STOP: enters RUNNING state
SMARTVISION™: toggles SmartVision™ function
OUTFLOW TRACKING: toggles Outflow tracking function
“prime” soft key: starts priming
In PAUSE and in RUNNING state, if PATIENT CASSETTE is not loaded, the following buttons are
enabled:
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 and in RUNNING state, if PATIENT CASSETTE is not loaded

SMARTVISION™ function is not active
OUTFLOW TRACKING function is not active
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 the following buttons have no effects:

DAY-SET
PATIENT-SET
ON/OFF
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:

Shaver
In RUNNING state calculated pressure inside the joint is shown on LCD.
In RUNNING state, when a Shaver Controller is connected to the pump, a SHAVER soft key
appears.
In RUNNING state, if:

PATIENT CASSETTE is loaded
and
the CANNULA foot pedal is pressed
and
the CANNULA WAY is OPEN
then
the flow is increased according to the set percentage while the foot pedal is pressed.
if SmartVision™ is active, the CANNULA pedal takes the priority over SmartVision™.

and
the RINSE foot pedal is pressed
and
the CANNULA WAY is OPEN and the others are closed
then
RINSE is activated: the output flow and the joint pressure are increased according to the set
percentage.
RINSE will be active until another foot pedal is pressed
RINSE will also turn off automatically after 2 minutes if not turned off by another action.
if SmartVision™ is active, the RINSE pedal takes the priority over SmartVision™.
When RINSE mode is activated the pump will beep once. At the end of the cycle the pump beeps
twice

and
the shaver is connected and the SHAVER foot pedal is pressed
and
the SHAVER WAY is OPEN and the others are closed
then
the flow is changed according to the shaver set flow value and the suction port is switched to the
SHAVER WAY while the foot pedal is pressed.
if SmartVision™ is active, the SHAVER pedal takes the priority over SmartVision™.
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

Cannula Pedal
SmartVision™ triggered (debris or hemoglobin detected)
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.

and
the SMARTVISION™ function is active
and
no SHAVER is active
and
neither CANNULA nor RINSE is active
then
the SMARTVISION™ algorithm is active and manages pressure and flow set point according to
measured hemoglobin and debris levels (See ANNEX)
As soon as the SHAVER function is enabled, the SMARTVISION™ algorithm is turned off.

and
the OUTFLOW TRACKING function is active
then
inflow pump will regulate the joint pressure with according to the OUTFLOW TRACKING algorithm
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 Day Cassette Control Board is received for more than 100 ms, the
Main Control Board blocks the system.
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
The SmartVision™ algorithm is described here by means of a state diagram.
haemoglobin>
haemoglobin_thh
The following states are defined:

State Flow Pressure
NORMAL F0 P0
DEBRIS DETECTED F1 P0
DEBRIS HOLD TIME F1 P0
HEMOGLOBIN DETECTED F2 P1
HEMOGLOBIN BLEEDING TIME F3 P1
The following flows are defined:

F0 normal operating flow
F1 Flow increased due to debris detection
F2 Flow increased due to hemoglobin detection
Flow increased due to hemoglobin detection and excessive
F3
bleeding time

P0 Normal operation pressure
P1 Pressure increased due to hemoglobin detection
The following time constants are defined:

The amount of time the state DEBRIS HOLD TIME is maintained
debris 10
after debris are cleared (debris<debris_th) prior to return in
hold time seconds
NORMAL state
The amount of time hemoglobin must be detected
bleeding 8
(hemoglobin>hemoglobin_th) in HEMOGLOBIN DETECTED state
time seconds
prior to enter the HEMOGLOBIN BLEEDING TIME state.
The following thresholds are defined:

debris_thh the minimum level to assess debris is present
debris_thl the maximum level to assess debris is cleared
hemoglobin_thh the minimum level to assess hemoglobin is present
hemoglobin_thl the maximum level to assess hemoglobin is cleared
When the SMARTVISION™ algorithm is activated or re-activated, the NORMAL state is entered.
Outflow Tracking
The OUTFLOW TRACKING algorithm is described as follows:

If the function is enabled during shaver, rinse or cannula actions, while pressure is between ± 30
mmHg around the set-point, the inflow pump runs at the same speed as outflow and, as a
consequence, P.I.D. control pressure algorithm is OFF. As the pressure goes outside the range
written above P.I.D. is restored.
Day Safety Module (DSM)
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:
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.

Architecture Design Chart
This section is provided as an overview of the software structure.
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
Unit Name Description

ANALOG SIGNAL This software unit elaborates data from AD
PROCESSING UNIT converter
EEPROM MANAGER It manages writing, reading and checking
the EEPROM memory
DIGITAL INPUT MANAGER It reads digital input data
ERROR CONDITION It detects the presence of an error and set
DETECTOR the error condition field
OUTPUT MANAGER It manages the error condition and the delay
on output
ROTOR PERIOD OBSERVER It calculates the period (in ms.) of Inflow
Motor rotation
SCI MANAGER It prepares the STATUS message and
sends it to Day Cassette Control Board
CONSTANTS FLASH memory constants for:
DSM_SW_VERSION
DSM_PROTOCOL_VERSION
DSM_MIN_PERIOD
4) DSM_MAX_PRESS

Signal description
Ite Signal Name Description

m
S1 DSM_CALIBRATION_DATA Calibration Data for pressure values.
S2 DSM_MEASURED_PRESSURE_1 PSENS1 Digitized value in mmHg
DSM_MEASURED_PRESSURE_2 PSENS2 Digitized value in mmHg
DSM_VDD_MONITOR Digital value of the pressure sensors power
supply (in 10 bits ADC counts)
S3 DSM_COVSW_FILTERED The digital value of the cover-lid sensor
DSM_PRESSW_FILTERED The digital value of the Day Cassette
presence switch sensor
S4 PSENS1_ADC ADC conversion result for PSENS1 (in a 10
bits ADC counts)
PSENS2_ADC ADC conversion result for PSENS2 (in a 10
bits ADC counts)
VDD_MONITOR_ADC ADC conversion result for VDD_MONITOR
(in 10 bits ADC counts)
S5 DCOVSW Cover-lid closing sensor (port register)
DPRESSW Cassette presence sensor (port register)
S6 ERROR_CONDITION_MASK It is a bit mask composed by these flags:
VDD_ERROR
OVERSPEED_ERROR
ROTATION_NOT_ALLOWED_ERROR
OVERPRESSURE_ERROR
SENSOR_MISMATCH_ERROR
S7 DHWERR Microcontroller output to cut-off
MOTOR_SUPPLY
S8 DTXPIC The serial line used by Day Safety Module
to communicate its STATUS message to
Day Cassette Control Board
S9 DSM_SW_VERSION software version
DSM_PROTOCOL_VERSION protocol version
DSM_MIN_PERIOD min rotor period allowed
DSM_MAX_PRESS maximum pressure allowed
S1 DHSENS Hall sensor detecting rotor speed (port
0 register)
S1 DSM_MEASURED_PERIOD Period expressed in rpm units
1

Operational Sequence Diagrams
The flow chart below describes the control flow of the software.

State Chart 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

If an error condition is present for a period longer than 2 seconds the Day Safety Module goes to this
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 Safety Link is active.
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.
Software Requirements Specification
Hardware
Day Safety Module (DSM) uses a Microchip PIC 16F688.
The microcontroller has 4K x 14 bits of Program Memory, 256 bytes of

RAM and 256 bytes of EEPROM.
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 uses serial connection to communicate

with Day Cassette Control Board
The configuration of serial connection is:

9600 bauds, 8 bits data, no parity, 1 stop bit
The Day Safety Module software reads the CALIBRATION_PIN (see

DCCBM schematics) input to activate the CALIBRATION state.
Software Performance and Functional Requirements
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 will check the integrity of the stored
program by performing a CHECKSUM test of the EEPROM space and
comparing this calculated value to the CHECKSUM value loaded when
the EEPROM was programmed. If the calculated CHECKSUM differs
from loaded value, the software will go into the FAULT state
The MCU COP watchdog timer will be activated.
If the INITIALIZE MCU sequence ends without errors, and if the

CALIBRATION_PIN is in Calibration Position the CALIBRATION state is
entered, else the software goes to NORMAL 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
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

IF
the pressure sensors power supply monitor is out of the [1.7 V, 2.6V]
acceptable range
THEN
Day safety Module software generates the error condition VDD_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
When the not recoverable CALIBRATION state is entered, the Day

Safety Module software 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
HARDWARE FAI LURE!

FAI LURE CODE:
XXXXXXXXXXXXXXXXXXXX
Pl eas e s wi t c h of f

Main Software Error Code
The error code is composed by 20 characters, to be more precise 10 hexadecimal numbers.
Error codes are listed below:
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

Module
0x50 Day Cassette Control Board timeout error in communication with Day Safety Module
0x51 Day Cassette Control Board CANBUS timeout error
0x52 Day Cassette Control Board motor initialization error
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
Safety Software Error Code

As described in the chapter 0, an error in the Safety Software produces an error also in the Main
Software, but the first cause is not evident.
It is possible a more meaningful error detection.
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.

The first frame shows the two hexadecimal number of the module checksum
The second frame (not used in PASM) shows the 2 pressure values read by the DSM. The first two
digits represent the hexadecimal value of the pressure read by DSM on the left sensor. This value
shall be multiplied by 5, to get the value in mmHg. The others represent the pressure on the right
sensor.
The third frame contains the Safety Error Code.
DSM error code

Hexadecimal Description
Error Code
00 No error
01 Checksum error
02 EEPROM error
03 Pressure sensor mismatch error
04 Overpressure error
05 Rotor over speed error
06 Rotation detected with cover open
07 Rotation detected with cassette loaded (only)
08 Incorrect VDD for pressure sensor board
09 Error during calibration
0A Error during calibration in point 1
0B Error during calibration in point 2
0C Error during calibration in saving data
0D Error during calibration in idle
PASM error code

Hexadecimal Description
Error Code
00 NO Error
01 Checksum error
02 EEPROM error
05 Rotor over speed error
06 Rotation detected with cover open
07 Rotation detected with cassette loaded

How to set the System Clock
In order to have a valid time stamp, the System Clock needs to be set; otherwise all records will
have a 01/01/2000 00:00:00 time tag.
Switch on the Double® Pump and go to the START screen: <<<<<<<START>>>>>>>
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.
CODE ERROR DESCRIPTION ACTION

16.... cover sensor there is a The cover shall be either well
mismatch "forbidden range" closed (during operation) or
of cover lid fully open when cassette
positions, approx. loading/unloading is under
10 to 20mm away way.
from the "full Check that the cover is not
closed" position. within the forbidden position
Holding the cover range
for more than 5
seconds in this
range gives the
error
....73.. overpressure whenever this pair let the pressure decrease in
is present in the the inflow tubing. Cycle the
error message, an mains switch OFF and ON
overpressure has again
occurred
....76.. day pump the Day rotor has if the rotor was moved by
rotation been moved by hand, cycle the pump OFF

hand while the and ON. If the motor rotates
cassette is not without reason, the pump
loaded, or the shall be placed out of service
motor runs without and repaired
being commanded
to do so
0AA1.... patient pump the Patient rotor if the rotor was moved by
rotation has been moved hand, cycle the pump OFF
by hand while the and ON. If the motor rotates
cassette is not without reason, the pump
loaded, or the shall be placed out of service
motor runs without and repaired
being commanded
to do so
....72.. pressure there is too much check that the sensors are
sensors difference in the clean and their surface is not
mismatch pressure measured damaged. If the error is still
by the two sensors on, proceed as explained in
paragraph 5 to read the left
and right pressure values.
Try with another Day
cassette, in case the cassette
membranes are displaced.
If there is a permanent
pressure difference, try to re-
calibrate the sensors. If this
fails, the pressure
measurement module needs
to be replaced
1A13.... Shaver or during the start-up cycle power OFF and ON and
1A14.... cannula ("T0") test, one of check if the affected pinch
1A15.... pinch valve the pinch valves valve is stuck or only slow to
error could not complete move. Check that there are
the test within the no foreign objects that impede
allowed time the movement. If the problem
persists, the pump shall be
placed out of service
PRESSURE MISMATCH ERROR
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.
while the error page is displayed, press both buttons: Show

OUTFLOW TRACKING (cog) and SMARTVISION™ (eye) button AdcRaw1: 490
AdcRaw2: 492

press "Show" (upper right) Show
1st TIME Gain1: 0.3110
Gain2: 0.2886

2nd TIME Offset1: 549
Offset2: 526

3rd TIME P1: 0 mmHg
P1= right P2: 0 mmHg
pressure sensor
P2= left
pressure sensor
press "Patient Cassette" RFID Test

1st TIME
D: 0000000000000000
P: 0000000000000000
Press "Patient Cassette" FIRMWARE CRC

2nd TIME MCB : 1FC3 BL: 170D
DCCB: 42DB BL:
C5D1
PCCB: 0D5E BL:
C5D1
Press "Patient Cassette" DSM
3rd TIME 00C7,0000,0200
left pressure / right PASM
pressure 0032,0000,0300
If the pump has been turned off and you wish to check the pressure sensors, please do the following:
Switch on the Double® Pump and go to the START screen: <<<<<<<START>>>>>>>
Setup
Press simultaneously P1: 50 mmHg Show

OUTFLOW TRACKING and SMARTVISION™ button AdcRaw1: 490
simultaneously AdcRaw2: 492
P2: 250 mmHg Save
Press "Show" (upper right) P1: 50 mmHg Show

1st TIME Gain1: 0.3110
Gain2: 0.2886
P2: 250 mmHg Save

2nd TIME Offset1: 549
Offset2: 526
P2: 250 mmHg Save

3rd TIME P1: 0 mmHg
P1= right P2: 0 mmHg
pressure sensor P2: 250 mmHg Save
P2= left
pressure sensor
Press "Patient Cassette" RFID Test

1st TIME
D: 0000000000000000
P: 0000000000000000
Press "Patient Cassette" FIRMWARE CRC

2nd TIME MCB : 1FC3 BL: 170D
DCCB: 42DB BL: C5D1
PCCB: 0D5E BL: C5D1
Press "Patient Cassette" DSM

3rd TIME 00C7,0000,0200
left pressure / right PASM
pressure 0032,0000,0300
Press "Patient Cassette" P1: 50 mmHg Show

4th TIME AdcRaw1: 490
AdcRaw2: 492
(THE SEQUENCE RESTARTS) P2: 250 mmHg Save
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

Alarms
Cause of Alarm Alarm Description Instruction to user
Front cover is opened Pump is stopped and “Close Close the front cover and
while the pump is running. Cover” appears on the display. press Run/Stop to
continue.
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.
Press Run/Stop button

again.
Overpressure ALARM: Pump stops and a continuous Turn off pump.

acoustic alarm sounds.
Pressure in Day cassette If replacing the Day
exceeds 300 mmHg “OVERPRESSURE ALARM” Cassette does not stop
appears in the display. the alarm, note the error
code, and contact
ERROR CODE XXXXXXXX Customer Service.
Read Op. manual and switch off
appears in the Display
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
Read Op. manual and switch off

appears in the Display.
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.
Surface Cleaning & Disinfection of Pump and Foot Control

DO NOT sterilize or immerse in liquid. Wipe clean with a soft cloth and mild detergent as needed.
Clean with detergents and disinfectants according to standard practices. Disinfect with liquid
chemical disinfectants such as chlorine solutions, iodophors, glutaraldehydes and hydrogen
peroxides. Follow manufacturer guidelines for concentration and length of exposure.

If needed, the pressure transducers on the front panel of the Pump may be cleaned. These are the
two white plastic discs inside the Day Cassette. Do not apply pressure or use any sharp objects, as
damage may result.

Assembly overview

Assembly drawing
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
* Drawn * Checked * Approved Scale
Date 28/04/08 28/04/08 28/04/08 1:1

Signature M. Dondi P. Massarutti A.P. Tolleranze espresse secondo UNI 3976
Tolleranze generali: design. m (media)
LEAN s.r.l. * Refer to original drawing if signatures are printed secondo UNI EN 22768-1:1996
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
Drawings and List of parts

NOTE All mechanical drawings are appended at the end of this manual. The cross reference list
reflects part No. to components that can be purchased from the Service Center.
List of parts
Image Part No Description
1402002 Double® Pump PS2 Front visor

1403001 Double® Pump PS3 Front visor
1404176 Double® Pump Foot Control 4-way

1404003 Double® Pump Foot Control 2-way
Double® Pump External body kit

2002008
PS2.
Double® Pump External body kit
2003008
PS3.
2002006 Double® Pump Front panel PS2.

2003009 Double® Pump Front panel PS3.
2003024 Loudspeaker Assembly.
2003010 Double® Pump Display kit

2003012 Double® Pump Rotor Front disc
2003013 Day Rotor, Double® Pump
2003014 Patient Rotor, Double® Pump
Day Cassette block,

2003015
Double® Pump
Patient Cassette assembled

2003016 holder,
Double® Pump

Pump Motor
2003017
Double® Pump
2003018 Pinch valve group of two
2003019 Power Supply
2003032 Keyboard Double® Pump
2003026 Equipotential ground connector
2003020 Main Control Board
2003021 Day Cassette Control Board

2003022 Patient Cassette Control Board
2003023 Footswitch Interface Board
2003025 Main power switch
1402009 Power Cord EU

1402010 Power Cord USA / CAN
1402012 UK
1402013 DK
1402014 Korea
1402015 China
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.

Disassembling and reassembling:
Example of repair: Replacing Main PCB. This procedure shows general disassembly and reassembly
processes that may be anticipated.
Tools/
Step Description Image
Note
Use a spacious
surface for
3.1 servicing the
Power™ Pump
Before opening the Electric

pump, always shock
3.2 remove the main hazard
power supply cable if this
step is
omitted
PH1
Unscrew the 4 side
Phillips
3.3 screws that hold
screw-
the top cover
driver

Step Description Image Tools/ Note
Rest the pump on

the rear panel and
3mm Allen
3.4 remove the top
key
cover front edge
(2 screws)
Raise the top

cover and gently
shift it rearwards.
Do not stretch any
3.5 cable. Lay the
cover slightly tilted
on the rear portion
of the machine
body.

Step Description Image Tools/ Note
Remove the mylar

3.6 foil leads (2).
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

Do not
Leave the flat cable remove the
that goes to the connectors
display attached to by pulling
the Main Control them from
3.9
Board (MCB). the cable.
Remove all the Grasp
other connectors instead
from the MCB each
connector
and gently
pull it out
Disengage the flat

cable at the
display end by
3.10 opening the two
connector side
latches.
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.

Put in place the
new MCB. Follow the
Push it all the way references
down until the printed on
board holders are each cable
3.12 latched when
plugging
Re-connect all the the
cables to the MCB, connectors
except the pinch in
valves cables
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

Tools/
Step Description Image
Note
Push connector
4.1 J19 (RS232) all
the way down

NOTE: the Display replacement flat-cable (p/n 0190.000) is a 34-wire cable with two
4.15 terminating female headers. For keying purposes, each header has 3 holes filled with
polarizing keys (pin #2, pin #33, and pin #34). This determines one (useful) 16-pin row
and one (forbidden) 15-pin row
Before closing the

top cover, organize
the cables as they
do not interfere
with the cover.
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.
Close the machine

by following back
the steps from 3.17
to 3.1
Mylar connectors
(depicted in step
3.14) should be
connected last

Preventive maintenance
An annual inspection of the Double® Pump to assess its functionality and technical safety is
advised. This must be made by a qualified Service engineer. Qualification is achieved by
attending a service seminar provided.
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.


Set up the pump unit with a Day and Patient Cassette. Cut the end connection of the intermediary
11. tube and connect it to the Patient Cassette right tubing.
Verify functions of pushbuttons and LED:s

Run the pump unit and open the Front visor. Verify that the pump heads stop and the display
12. indicates “Close cover”.

Ensure that the pump can be controlled by a shaver. Make sure the Pinch valves closes and opens
13. and have a free and full movement.

Verify function of Foot control and that they are reasonably clean.
14.
Connect a suction manometer to the shaver connection of the Patient cassette. Activate the shaver
15. function and check that the suction is 300‐600mmHg (40‐80kPa).

Use a timer, scale and beaker to verify flow at 100 and 300 ml/ min. This should be within 10% of
16. set value.

17. Perform the Electric safety test


Preventive maintenance Report form
System Identification
Pump Type Owner
Serial Number Owners order number
STEP DESCRIPTION Pass/ Fail

1 Labels intact, everything readable, Pump unit clean.
2 Inspection for damages
3 Inspect power inlet, power cord, RS232 and Shaver interface
4 Correct software
5 Inspect error log
6 Verify correct Date and time
7 Inspect Pressure arm movement
8 Inspect sensor for Cassette positioning
9 Pressure Verification

Pressure Display Pressure manometer
100 mmHg mmHg
200 mmHg mmHg

Pressure should be in the tolerance of ± 15 mmHg
10 Alarm Verification:

Low pressure warning < 40 mmHg
High pressure warning > 250 mmHg
High pressure alarm > 300 mmHg

11 Verify function of all pushbuttons (and LED:s)
12 Verify that pump head stop when the front visor is opened
13 Verify Shaver control function and Pinch valve action
14 Verify functions of foot control and that they are reasonably clean
15 Verify that the shaver suction is 300‐600 mmHg (40‐80 kPa)
STEP DESCRIPTION Pass/ Fail

16 FLOW CHECK
Flow Flow Result
Flow 100 ml/ min ml/ min
Flow 300 ml/ min ml/ min
Tolerance +‐ 10%

17 Electrical Safety test ( See separate report )


Comments

Conclusion
MAINTENANCE ACTIVITIES COMPLETED

TEST PASSED

TEST FAILED

NOTES:

Service Identification
Operator Name
Operator Organization
Date
Location

Date/ Operator Signature
Copy filed to Distributor / Manufacturer -------------------------------

Technical Specifications
PUMP
Input Voltage (dual range) 100-120 / 220-240 V~
Input Frequency 50/60 Hz
Power consumption 230 VA (Peak)
Fuse Rating T 3.15 A; 5 x 20 mm
Maximum pressure 180 mmHg

Maximum flow 600 ml/min
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.)
INTERFACE CABLES FOR SHAVER (OPTIONAL)

Length 2.9 m (9.5 ft.)

Pump Classification and Safety Verification
Classification
Complies with IEC 60601-1 with Amendments 1 & 2.
It has been designed and it is compliant with the following harmonized standards:
EN IEC 60601-1:1998 General requirements for safety
EN IEC 60601-1- General requirements for safety - Collateral standard: Safety
1:2001 requirements for medical electrical systems
EN IEC 60601-1- General requirements for safety - Collateral standard:
2:2001 Electromagnetic compatibility - Requirements and tests
EN IEC 60601-1- General requirements for safety - Collateral standard:
4:1996 Programmable electrical medical systems Methodology
EN IEC 60601-1- Medical electrical equipment - Part 1-6: General requirements for
6:2004 safety - Collateral standard: Usability
According EN IEC 60601-1, the Pump is classified as follows:
Type of protection against electrical shock: Class I equipment
Degree of protection against electrical shock: Type BF applied parts
Degree of protection against harmful ingress of water:
Pump meets requirements of IEC/EN 60601-1, sub clause 44.3.
Foot Control meets requirements of IEC/EN 60601-1, watertight construction (IPX8).
Equipment not suitable for use in the presence of flammable anesthetics.
Mode of operation: capable of continuous operation.
Symbols
Name Address of manufacturer
Serial Number
Product Code
Power Supply Voltage (VAC)
Electrical Power
WARNING Symbol. Refer to factory documentation
Consult User Manual.
Type BF Applied Part
Equipotential Ground Symbol

The Double® Pump and its disposables are covered by Swedish patent SE600718-1 and SE526008,
European Patent Application 07748355, US Patent Application 11/729,357, WO2009/123547 and other
utility- and design- patents and patent applications in different geographical areas; all of these owned by
Medical Vision AB, Sweden.
Manufactured by:
Medical Vision® AB
Hästholmsvägen 32
SE-131 30 NACKA
SWEDEN
+46(0)8 452 49 50
www.medicalvision.se

L-2012-006-01

Medical Vision Double Pump Service Manual

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Medical Vision Double Pump Service Manual

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Medical Vision®

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Version 1.0. This corresponds to Software version DP_2_4_0.

Date Version Software version

Responsibilities and authorization ............................................................................................... 5

L-2012-006-01 Service Manual Double Pump 3

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Hazards related to servicing

The Double® Pump system consists of the following components:

Unpacking, Assembly, and System Check

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1. Double® Pump 4. Shaver

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Controls & Indicators

1. Day Cassette button

3. Outflow Tracking button

4. Pressure increase/decrease buttons

5. Soft Keys (4)

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10. Patient Cassette button

11. Pump Foot Control Receptacle

12. On/Off switch

13. Serial Communication Port

14. Tone Volume Control

15. Power Cord Receptacle/Fuse Holder

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17. Shaver Connection

18. Shaver Connection

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Cassette position sensing

The Day Cassette

The Patient Cassette

Accurate control of pressure in the joint:

Compensation for resistance

Resistance = Ppump – Pcavity

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Electronic Hardware Description

Part No Interconnection cables

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It implements the human machine interface:

It stores the preset values for several surgical procedures.

The microcontroller used is the Freescale MCU-DSP 56F8347.

Day Control Board

Patient Control Board

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If the Cover-lid is open then the motor must be stopped.

Day Safety Module

The microcontroller used is the Microchip PIC 16F688.

Patient Safety Module

The microcontroller used is the Microchip PIC 16F688.

To enter the service mode – from the Start menu press

In Service mode, the following settings can be made:

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Power on the system.

Setup mode functions:

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