Angiodroid The CO₂ Injector: Service Manual July 2021

ANGIODROID THE CO2 INJECTOR

Carbon dioxide injector for angiographic use
-----------------

Service Manual

Date of issue : 07/2021

Version : 11

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Index
1 Introduction ........................................................................................................................................ 3
1.1 General information ............................................................................................................................ 3
2 Description.......................................................................................................................................... 7
2.1 Technical characteristics...................................................................................................................... 7
2.2 Control panel ..................................................................................................................................... 11
3 Wiring diagrams ................................................................................................................................ 12
3.1 Block diagram .................................................................................................................................... 12
3.3 Power supply and stepper motor wiring diagram ............................................................................. 14
3.4 Wiring diagram solenoid valves ......................................................................................................... 15
3.5 Wiring diagram PC-LCD-ENCODER.................................................................................................... 15
4 Control unit ....................................................................................................................................... 17
4.1 Electronic board interconnections .................................................................................................... 17
5 ULTIMOD Excelsys power supply unit................................................................................................. 17
6 Opening and closing internal parts of Angiodroid The CO₂ Injector ...................................................... 21
6.1 Procedure for opening internal parts of the device .......................................................................... 21
6.2 Procedure for closing internal parts of the device........................................................................... 26
At this point the device will be completely closed. ................................................................................ 26
7 Calibrations ....................................................................................................................................... 27
7.1 Console Calibration............................................................................................................................ 27
7.1.1 Calibration of the syringe start SWITCH ........................................................................................ 27
7.1.2 Calibration of the syringe end stop SWITCH .................................................................................. 30
8 Installation ........................................................................................................................................ 33
8.1 Power grid connection....................................................................................................................... 34
9 Maintenance ..................................................................................................................................... 35
9.1 Maintenance of electrical components ............................................................................................. 35
9.2 Maintenance via Software................................................................................................................. 36
9.2.1 Test Area ......................................................................................................................................... 36
9.2.2 Check-Up Area ................................................................................................................................ 39
9.3 Maintenance of mechanical components ......................................................................................... 41
10 Programming Procedure for the Firmware on the Actuator Board, Control Board and Button Board .. 86
11 Setting the PC Card IB898 Bios ......................................................................................................... 91
12 Programming procedure for the motor drive .................................................................................... 93
13 Positioning of grounding point symbols............................................................................................ 96

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1 Introduction
1.1 General information

Angiodroid The CO₂ Injector is a device that allows the injection of CO2 (carbon dioxide) as a
contrast medium into blood vessels, at specific pressures and volumes. It is recommended to
use with a digital angiograph (DSA = Digital Subtraction Angiography), together with a
software that allows the overlapping of images, to improve the quality and diagnostic value
of the images obtained.

The control panel is made according to ergonomic criteria so that, thanks to the disposition
of the controls, the digital reading of the parameters and the indications of the functions on
the graphic display make the programming and use of the injector immediately teachable
and without possibility of error.

The equipment has been designed and manufactured according to the European standard
EN 60601-1. According to this standard, the equipment is placed in class I with applied part
of type CF.
According to the medical devices standard 2007/47 EC the equipment is placed in class IIb.

The equipment has been manufactured to meet the requirements of EN 60601-1-2 and therefore
its use in rooms with electromagnetic field and interference levels higher than those specified in
the standard is not recommended. Figures 1-2-3 show the main components of the equipment.

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Operator Interface (ANG00015)

- PC card with touch 8" colour LCD

- Two wired encoders, equipped with knobs for

adjustments

- Two speakers

- Two LEDs (orange and green) for injection

preparation phase and ready injector.

Pneumatic drives and control electronics group

(ANG00016)

- Set of electronic control boards

- Set of five solenoid valves

- Charge Tank with rigid walls

- Tank with the two pressurized bags and CO2 injection

bag *

Central body group (ANG00018)

- Electrical wiring with sockets and mains

switch and ground connections.

- Pressure regulators and pressure gauges

for CO2 cylinder
- CO2 cylinder

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Fig.1

Fig.2
*Particular of the tank with the
two pressurized bags and the CO2
injection bag

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Actuator Dorsal Block (ANG00017)

- Mains power supply for low voltage
- Stepper motor unit / support bracket with
worm screw / syringe and related limit
switches
- Electric drive for stepper motor
- Air pump
- CO2 output connector
- Connectors for USB, VGA.
- Hinges for keeping the solenoid valve
platform in position during maintenance
(CO2 cylinder replacement)

Fig.3

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2 Description

2.1 Technical characteristics

A – GENERAL

Control panel Touch screen

Injection Programming Digital

Data reading Digital

Quantity available per syringe 60 ml

Injection volume 10 – 100 ml with 1ml steps

Injection pressure 6,67 – 46,7 KPa

50 – 750 mmHg

Injection parameters display By LCD touch screen

Parameters displayed • Estimated residual cylinder

capacity
• Time elapsed since last injection
• Pressure detected inside the
Charge Tank
• Injection parameters set

Alarm conditions displayed • Room air inlet

• Internal pneumatic circuit
pressure too high
• Internal pneumatic circuit
pressure too low
• Malfunction EV2 -> possible air
contamination
• Serial communication error with
stepper motor.

On/off buttons with indicator light Certified button, illuminated green, with
two positions (on/off)

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B - EXTERNAL CONNECTIONS

Power cable 2.5 mt

C – POWER SUPPLY

Mains voltage 110 – 240 VAC

50 – 60 Hz

Power consumption at 240 VAC mains V = 240 V

voltage F = 50 Hz
I = 526 mA (max peak)
I = 259 mA (stand-by)
P = 102 W
Q = 49 VAR
PA = 112 VA
Power factor = 0,82
Power consumption with mains voltage V = 110 V
110 VAC F = 60 Hz
I = 973 mA (max peak)
I = 358 mA (stand-by)
P = 106 W
Q = 23 VAR
PA = 108 VA
Power factor = 0,92

D – ENVIRONMENTAL WORKING CONDITIONS

Temperature +5 °C / +35 °C

Relative humidity 30% / 75%

Atmospheric pressure margin 700 / 1060 hPa

E – ENVIRONMENTAL CONDITIONS OF STORAGE AND TRANSPORT

Temperature -5 °C / +50 °C

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Relative humidity 30% / 90%

Atmospheric pressure margin 700 / 1060 hPa

F – DIMENSIONS AND WEIGHT

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H = 108 cm

D = 57 cm
W = 41 cm

Height 108 cm
Width 41 cm
Depth 57 cm
Weight 43 kg

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Accessories

ACCESSORIES LIST

Code Description UM Quantity

FUSE 3,15 A T NR 2

Power cable NR 1

Handpiece for remote injection NR 1

Ziehm Sync Cable NR 1

Philips Sync Cable NR 1

2.2 Control panel

1. Touch screen
2. Knobs for pressure and volume adjustments
3. Touch screen pen

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3 Wiring diagrams

3.1 Block diagram

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3.2 General scheme and interconnections

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3.3 Power supply and stepper motor wiring diagram

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3.4 Wiring diagram solenoid valves

Orange

Yellow

Grey

Green

Blue

Purple

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3.5 Wiring diagram PC-LCD-ENCODER

INTERFACE MODULE:
PC-LCD-ENCODER ELECTRONIC WIRING

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4 Control unit

4.1 Electronic board interconnections

SOLENOID VALVES MODULE:

ELECTRONIC BOARDS WIRING

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5 ULTIMOD Excelsys power supply unit

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6 Opening and closing internal parts of Angiodroid The CO₂ Injector

6.1 Procedure for opening internal parts of the device

1. Open the door
compartment using the
handle shown in the
illustration.

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2. Unscrew, in both lateral

circular rings, the screw
that blocks the vertical
cover.

3. Lift the vertical cover of

the device (user
interface lock).

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4. Unscrew the 4 screws

shown in the figure to
release the solenoid
valve support plate from
the outer plate.

4*. Unscrew the 2 screws

shown in the figure to
release the solenoid
valve support plate from
the outer plate.

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5. Then lift the solenoid

valve support plate and
secure it with the
dedicated locking rod.
The locking rod must be
positioned on the right
side of the injector as
shown in the figure.

locking rod

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5*. Then lift the solenoid

valve support plate with
the two side lifting rods.
Insert the two rods into
the holes shown in the
figure.

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6. At this point the device

is completely open, and
every component inside
will be accessible

6.2 Procedure for closing internal parts of the device

Repeat backwards the steps just listed in paragraph 6.1 in order to close all the internal
parts of the device. A short list of steps is given below:

1. Close the solenoid valve support plate by removing the locking rod or lowering the
two side lifting rods.

2. Tighten the four fixing screws on the solenoid valve support plate or the two lateral
fixing screws.

3. Close the head of the device and screw the two screws into the two lateral metal
ferrules.

4. Close the front door compartment.

At this point the device will be completely closed.

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7 Calibrations
7.1 Console Calibration

7.1.1 Calibration of the syringe start SWITCH

CONSULT THE STEPS FOR OPENING
THE INTERNAL PARTS OF THE DEVICE
(Par. 6.1)

• Open the injector compartment

• Open the vertical cover
• Lift the support plate of
the solenoid valves
• Lock the solenoid valve
support plate
• If necessary, remove the
cylinder and pressure
regulator by following the
BOMB REPLACEMENT
procedure.

1. Slightly unscrew the Allen

screws of the start switch
block (use a 2 mm Allen
wrench) to release it from
its position, and manually
advance the plunger to
the 0 ml position.

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1*. Slightly unscrew the cross

screws on the cam of the
white delrin block.

2. Correctly position the

start switch block so that
the micro-switch triggers
when the syringe plunger
is positioned at 0 ml.

2*.Correctly position the

lower metal block so that
the microswitch operates
when the syringe plunger
is positioned at 0 ml.

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3. Turn on the injector. Select

SERVICE / MAINTENANCE / TEST

4. Check the correct

calibration by clicking on
RESET. Check that the
syringe plunger is actually
positioned at 0 ml and
that the micro-switch
switch is triggered.

5. Then return to the main

menu

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7.1.2 Calibration of the syringe end stop SWITCH

CONSULTING THE PASSIONS FOR

OPENING THE INTERNAL PARTS OF THE
DEVICE (Par. 6.1)
• Open the injector compartment
• Open the vertical cover
• lift the support plate of
the solenoid valves
• Lock the solenoid valve
support plate
• Remove cylinder and
pressure regulator by
following the detailed
procedure CYLINDER
REPLACEMENT.

1. Unscrew slightly
(NB: Slightly, NOT TOTALLY)
the screws of the limit switch
block to unlock it from its
position (use a 2mm size
Allen key).

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1*. Slightly unscrew the

crosshead screws of the
lower cam of the white
delrin block.

2. Manually advance the

piston to the 60 ml
position.

3. Correctly position the end

stop block so that the
micro-switch operates
when the syringe piston is
positioned at 60 ml.

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2*.Correctly position the

lower metal block so that
the microswitch operates
when the syringe piston is
positioned at 60 ml.

4. Switch on the machine

5. Select SERVICE /
MAINTENANCE / TEST

6. Load 60 ml and start

handling by clicking ON.

7. Verify the correct calibration of

the microswitch by checking that
the switch is correctly activated
at 60 ml.

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8 Installation

The installation must be carried out by qualified technical personnel who have attended the
manufacturer's training courses.

Only authorized personnel may remove the machine covers and access the internal parts of
the machine under tension.

Before connecting to the mains, check that the CO2 cylinder is open and that the outlet
pressure from the pressure reducer is in the range 0.4 and 0.7 bar. To do this, carefully carry
out the following operations:

CONSULT THE STEPS FOR OPENING THE

INTERNAL PARTS OF THE DEVICE (Par.
6.1)

• Open the injector compartment

• Open the vertical cover
• Lift the support plate of
the solenoid valves
• Lock the support plate of
the solenoid valves with
the appropriate locking
rod or with the side lifting
rods.

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1. Open the valve on the

CO2 cylinder.

2. Check that the outlet

pressure gauge of the
pressure regulator
(shown in the figure) has
an outlet pressure
between 0.4 and 0.7 bar.

3. Check that the inlet

pressure gauge of the
pressure regulator
(shown in the figure) has
an inlet pressure between
50 and 60 bar.

8.1 Power grid connection

Before connecting to the mains, make sure that the supply voltage corresponds to
the value indicated on the device's label.

Once the verification is

complete, connect the
power cord to the socket
shown in the figure.

In these conditions the machine is ready to be started.

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For more information on the operation of the device, refer to the user manual of
Angiodroid The CO₂ Injector.

9 Maintenance

Maintenance must be carried out by qualified technical personnel who have attended the
manufacturer's training courses.
Only authorized personnel may remove the machine covers and access the internal parts of
the machine under tension. Before connecting the machine to the mains, open the machine
(following the steps described in paragraph 6.1), check that the CO2 cylinder is open and that
the outlet pressure gauge of the pressure regulator is fixed and between 0.4 and 0.7 bar (see
the procedure already described in paragraph 8 for installation).

Any anomaly found by the maintenance technician with respect to the specifications
provided by the manufacturer must be promptly notified to Angiodroid Srl.
In the event of an anomaly found, the maintenance technician must identify the device by
Serial Number and record the anomaly in the Technical Assistance and Maintenance module
in the "Comments" section, so that the manufacturer can take the necessary corrective
actions and restore product conformity.

9.1 Maintenance of electrical components

The Angiodroid The CO₂ Injector is designed to work for a long time with a minimum of
periodic maintenance. The periodic maintenance consists of an annual check of the main
safety circuits of the machine and, if necessary, of a recalibration.

Perform the following checks:

• Turn on the machine and check that there are no error messages indicating
"Contact Service" on the display.
• Check the pressure reading circuit from the maintenance area of the device.
• Check the calibration of the start and end switches.

For devices already present on the market, tests of Electrical Safety will be carried out in
cases of ordinary or extraordinary maintenance:

For devices already placed on the market, the Electrical Safety test must be carried out in
cases of interventions which:
• Alter the connections for the protective earth;

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• Involve the replacement of parts of the metal case connected to the protective
earth;
• Require the replacement of the PC block, including the touch-screen (ANG00046);
• Involve the replacement of the power supply or parts of the power supply
(ANG00067, ANG00068, ANG00069).

In the cases listed above it will be necessary to perform Electrical Safety tests according to
IEC 62353, with Direct Method for the measurement of leakage currents. It is not considered
necessary to measure the Insulation Resistance. Particular attention must be paid to the
"Continuity of Grounding" test. Although the IEC 62353 standard provides for a threshold
value up to 0.3 ohm, it is considered appropriate to evaluate as Non-Compliant a value
higher than 0.150 ohm. In this case, the maintenance technician must identify the device in
question as NON-CONFORMING unless the test is repeated with the appropriate power cord
and the values are within the validation range (R < 0.150 ohm).

9.2 Maintenance via Software

The Angiodroid The CO₂ Injector has two software environments that allow to verify the integrity
and the pneumatic seal of the system:

1. Test Area
2. Check Up Area

9.2.1 Test Area

The TEST AREA of the Angiodroid The CO₂ Injector is accessible from the Menu by selecting:
SERVICE/MANAGEMENT (password entry: ABC123) /TEST.

The screen that will appear will be the following:

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1
3

2 4

This screen is divided into different areas, each of which is dedicated to the individual use of each
actuator/sensor inside the injector.

The various areas dedicated to the various actuators are listed and described below:

• 1 Solenoid Valve Area: The solenoid valve area allows to open and close each solenoid
valve in the system. Pay attention to the opening of the EV1 valve, as it is directly
connected to the pressure reducer and therefore to the cylinder. To test this solenoid
valve, it is recommended to open the valve only for a few seconds and close it
immediately.
• 2 Syringe area: The Syringe Area allows the operator to test the movement of the syringe
plunger. It is always recommended to open the EV2 before moving the plunger or
disconnect the luer-lock connector of the syringe, so that the stepper motor does not work
with negative pressures: this could damage the motor! Click on "VOL" to set the level
(volume) to which you want to move the plunger, and then click on "ON" to activate the
movement. The "RESET" button brings the syringe plunger to 0 ml, automatically opening
the EV4 valve in order to open a gas escape route to the outside and not unnecessarily
force the motor stepper to work with high pressures.

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• 3 Compressor Area: The Compressor Area allows the operator to test the functionality of
the compressor. It is recommended to load the injection bag with 60 ml of gas in advance,
and then activate the compressor (this is recommended in order to have gas inside the
injection bag to allow pressure monitoring). Click on "PRESS" to set the desired pressure
value and then click on "ON" to activate the compressor. During compressor activation you
will be able to notice the pressure increase inside the injection bag by monitoring the value
indicated under the label "Injection bag". During compressor activation the "ON" button
automatically becomes "OFF": click on "OFF" to instantly stop the compressor. Once the
desired pressure is reached, you can continue monitoring the pressure at intervals by
clicking on "UPDATE". To activate continuous monitoring of the pressure value, click on the
"AUTO UP" button. Then click on "READ OFF" to exit the continuous pressure monitoring
mode. To check the pressure inside the pressurized bags, click on the "UPDATE" button
next to the "Sp" label: in this case the monitoring will be continuous.
• 4 Sensors Area: The Sensors Area allows the operator to monitor the pressure trend of the
various pneumatic chambers of the injector:
o Sdc = pressure inside the charge Tank
o Sp = Pressure inside the Pressurized Bags
o Syringe = Pressure inside the syringe and in all the pneumatic tubing between EV2 -
EV3 - EV4
• 5 Calibration Area: The Calibration Area allows you to calibrate pressures using a second-
degree polynomial. To set a single offset, simply set:
o Par a = 0
o Par b = 1
o Par c = offset
• 6 Pressurized Bags Test Area: Pressurized Bags Test Area: The Bags Test Area allows to
perform a fatigue test of the pressurized bags. Once activated, the system will perform 100
loading and unloading cycles of the pressurized bags at a pressure inside the injection bag
of 350 mmHg. It is recommended to pre-load the injection bag with 60 ml of gas and then
start the test.
• EV Opening Time: The EV Opening Time Area allows the operator to change the opening
time, and the opening speed of the Solenoid Valve 4.
• Cycle 1: Allows the operator to start Cycle 1, i.e. the injector initialization cycle. It is
mandatory to start this cycle before you can use the Syringe Area. In fact, this cycle
controls the syringe start and end switches, and loads the Charge Tank with CO2 gas at 180
mmHg.
• Functional Diagram: Allows the operator to view the pneumatic circuit diagram, which
shows the positioning of all the solenoid valves, the various actuators and sensors.

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9.2.2 Check-Up Area

The CHECK-UP AREA of the Angiodroid The CO₂ Injector is accessible from the Main Menu by
selecting: SERVICE / MAINTENANCE (password entry: ABC123) / CHECK-UP. The screen that will
appear will be as follows:

This section performs an automatic test to check the tightness of the various pneumatic chambers
present in the circuit. The three sectors analyzed are:

• SdC = Charge Tank

• Syringe = Syringe + tube circuit between EV2, EV3 and EV4
• SdI = Injection bag

The test starts as soon as you click the CHECK-UP button. There is a ListBox for each analyzed
sector. During the leak test, the pressure values detected by the pressure sensor (FUJIKURA
025KPa) in the different compartments appear in these ListBoxes. These values remain displayed
within these ListBoxes for later review. Typical test values indicate pressures between 70 / 90
mmHg.

The test is carried out with sequential checks of the various chambers of the pneumatic circuit,
starting from the Charge Tank (SdC) and ending in the Injection Bag (SdI). The term sequential
indicates that at each chamber passage, the sector under test remains in communication with the

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previously tested chamber. This means that, during the SdI test, the tightness of the entire
pneumatic circuit is being checked as each chamber is connected to the other two.

The success criteria of the leak test are highlighted below:

Tolerance allowed by reading the

Sector Range Monitoring Time (s) first value
(mmHg) (mmHg)

Sector 1 - SdC [175-155] 10 -5

Sector 2 - Syringe [90-120] 10 -5

Sector 3 - SdI [220-200] 20 -7

The outcome of the test depends on these criteria. If the test fails, the software indicates the
room where the leak was detected.

If there is a leak in the SdI (Injection Bag) sector, it is advisable to access the Test Area (from Main
Menu: SERVICE / MAINTENANCE (password entry: ABC123) / TEST) and perform a test on the
pressurized bags, inflating them to a pressure of 250 mmHg and monitoring the SP pressure
sensor. If the monitored value shows a continuous drop, the leak is located in one of the
pressurized bags. Refer to the section on pressurized bags replacement in section 10.2 to
investigate this event.

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9.3 Maintenance of mechanical components

The following are the checks which must be carried out at least once a year.

PRESSURE REGULATOR

Check the correct fixing of the pressure regulator to the cylinder.

The checks that must be performed annually or when the 150 procedures performed using
the Angiodroid The CO₂ Injector are reached, are indicated below.

SYRINGE block 1.0

1. Turn on the injector,

2. Access the SERVICE / TEST area
3. Start cycle 1
4. Open EV2
5. set the plunger of the syringe to 30 ml.
6. Close EV2

* See section 9.2.1 for more details on

the use of the Test Area

7. Turn off the injector using the

appropriate switch.

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8. CONSULT THE STEPS TO OPEN THE

INTERNAL PARTS OF THE DEVICE (Par.
6.1)

• Open the injector compartment

• Lift the vertical cover
• Lift the solenoid valve support
plate
• Lock the solenoid valves
support plate with the
appropriate locking rod

9. Disconnect the transparent luer-

lock connector (shown in the
figure) from the syringe.

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10. Unscrew the anchor setscrew of

the threaded pin that fits into the
stepper motor (i.e. the Allen key
indicated by the green arrow in the
figure on the side; use an Allen key
with a size of 2.5 mm).
It is not necessary to unscrew the
setscrew completely: just loosen it.
Then push the endless screw
upwards in order to release the
coupling from the stepper motor
pin (see figure in point 11 where
you can see the endless screw
released from the coupling).

11. Unscrew the 2 knob screws that

secure the metal plate and hold the
syringe in place (picture on the
side).

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12. At this point the unit "plunger +

syringe + endless screw" will be
completely released and can be
extracted.
Once the block has been removed,
it is advisable to remove the
setscrew so that the joint can be
repositioned on the stepper motor
pivot when point 16 is reached.

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13. Replace syringe and rubber plunger

tip. Then insert the plunger body
into the syringe up to
20 ml.

14. Then replace the syringe in its

housing by partially tightening the
2 knob screws of the metal plate
(picture on the side). The fins of
the syringe must be locked
between the two plates as shown
in the figure to the side.

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15. Push down the endless screw,

repositioning the coupling on the
motor pin.

16. When repositioning the coupling

on the motor pin, the coupling
hole must be aligned with the
circular breakout on the motor
pin.

NB: the first injector versions (SN

AE0031 to SN AE0060) may not
have the circular breakout on the
engine pin. In these cases, the
coupling hole must be matched to
the flat part of the stepper motor
pin.

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17. Once the correct alignment has

been found, it is now possible to
screw the setscrew back into the
coupling using the 2.5 mm Allen
key.

18. Tighten the two knob screws

correctly to secure the syringe.
CAUTION: The 2 knob screws must
be screwed at the same level to
avoid misalignment of the metal
plate.

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19. Check the position of the start

and end switches shown in the
figure.

If the switches are moved during

the syringe extraction phase,
reposition them correctly by
lightly unscrewing the 2 anchor
screws shown in the figure.

Consult the recalibration section

of the switches in paragraph 7.

20. Connect a new luer-lock

connector to the syringe.

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21. CONSULT THE STEPS FOR CLOSING THE

INTERNAL PARTS OF THE DEVICE (Par.
6.2)
At the end of the operation, close
properly:
• Solenoid valve support plate
• Vertical cover by fixing the two
screws
• Front compartment

22. At the end of the operation, turn on the

injector and access the Test Area. Start
Cycle 1 and wait for the initialization to
finish.
Using the syringe plunger handling area,
verify the correct calibration of the
syringe and the intervention of the two
microswitches (start and end stroke). In
case of incorrect positioning of the
microswitches, consult the section
dedicated to their recalibration.

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23. Start the CHECK-UP test to verify that

no leakage has occurred after syringe
replacement.

24. At the end of the checks, perform a

CIRCUIT WASH from the SERVICE
Menu.

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SYRINGE block 2.0

1. Turn off the injector using the

appropriate switch.

2. CONSULT THE STEPS TO OPEN THE

INTERNAL PARTS OF THE DEVICE (Par.
6.1)

• Open the injector compartment

• Lift the vertical cover
• Lift the solenoid valve support
plate
• Lock the solenoid valves support
plate with the appropriate locking
rod

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3. Disconnect the transparent luer-lock

connector (shown in the figure) from
the syringe.

4. Unscrew the 3 knobs shown in the

figure to be able to loosen the grip on
the syringe fins (red arrows) and on its
plunger (blue arrow)

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5. The syringe support assembly will then

remain as shown in the figure.

6. Place a new syringe with its original

plunger on the block, and screw the
knobs to secure the syringe wing lock
bracket (red arrows) and the knob to
secure the syringe plunger (blue
arrow)

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7. At the end of the operation, turn on

the injector and access the Test Area.
Start Cycle 1 and wait for the
initialization to finish.
Using the area dedicated to the syringe
plunger handling, verify the correct
calibration of the syringe and the
intervention of the two microswitches
(start and end position). In case of
incorrect positioning of the
microswitches, consult the section
dedicated to their recalibration.

8. Start the CHECK-UP test to verify that

no leakage has occurred after syringe
replacement.

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9. At the end of the checks, perform a

CIRCUIT WASH from the SERVICE Menu.

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ENDLESS SCREW LUBRICATION

1. CONSULT THE STEPS TO OPEN THE

INTERNAL PARTS OF THE DEVICE (Par. 6.1)
• Open the injector compartment
• Lift the vertical cover
• Lift the solenoid valve support plate
• Lock the solenoid valves support
plate with the appropriate locking rod

2. Ensure that the syringe plunger is

positioned at 0 ml. Then apply a
lubricant spray to the central point of
the endless screw (indicated by the
red arrow) and move the syringe 4
times between 0 and 60 ml to
distribute the lubricant over the
entire threaded screw.

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3. CONSULT THE STEPS FOR CLOSING THE

INTERNAL PARTS OF THE DEVICE (Par. 6.2)

At the end of the operation, properly

close:
• Solenoid valves support plate.
• Injector head fixing the two screws.
• Front compartment.

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PRESSURIZED BAGS and INJECTION BAG REPLACEMENT

1. CONSULT THE STEPS FOR OPENING THE

INTERNAL PARTS OF THE DEVICE (Par. 6.2)

• Open the injector compartment

• Lift the vertical cover
• Lift the solenoid valve support plate
• Lock the solenoid valves support
plate with the appropriate locking rod

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2. Unscrew the 6 screws (shown in the

picture on the side) of the rectangular
metal box that hold it fixed to the
solenoid valve support plate.

NB1: 3 Screws on the right side of the box

shown in the figure.

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NB2: 3 screws on the left side of the box

shown in the figure.

3. Then pull the metal box downwards. At

this point the 3 bags (2 blue pressurized
and 1 transparent injection) will be
exposed and accessible as shown in the
picture on the side.

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4. PRESSURIZED BAGS + INJECTION BAG +

LUER-LOCK CONNECTORS REPLACEMENT
1. Disconnect the luer-lock connector
tubes of the bags from the super
rapid joint fittings and then also
disconnect the bags.
2. Then connect the new pressure bags
(blue) and injection bag (transparent)
with new luer-lock connectors.

NB1: in some cases, it may be difficult to

disconnect the luer-lock connectors. In
such cases, disconnect the luer-lock
connector tube from the super rapid joint
fitting and then replace this connector as
well.

The connector lengths for the two types

of bags are different:
• L = 37mm - pressurized bags
• L = 46 mm - injection bag

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NB2: Pressurized bags have a mounting

direction: the short side of the bag must
face the inside of the injector, while the
long side faces the outside.

On the contrary, the long side of the Pressurized bags

injection bag must face the inside of the
injector, while the short side must be
outside.

Injection bag

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5. Reposition the previously extracted metal

box, paying attention to the correct
positioning of the bags with respect to the
hinged plates inside. Use the rectangular
cavities on the body of the metal box
(shown in the figure), moving the internal
plates with your fingers:
• The two pressurized bags (i.e. the 2
outermost ones) must remain outside
the plates.
• The injection bag (i.e. the bag in the
center) must remain positioned
between the two plates. Check that
the slots on the plates are parallel to
the tubes of the injection bag.

6. The bags inside the metal box must be

positioned as shown in the figure to the
side, that is:
• Injection bag between the two
plates
• Pressurized bags on the outside of
the plates

NB: DO NOT OPEN the metal box as

shown in the picture. The image has
only explanatory purposes to better
clarify the positioning of the bags
inside.

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7. Once the new bags are connected,

reinsert the metal box from below.

8. Then tighten the 6 screws of the metal

box (shown in the figure) in order to
reattach it to the solenoid valve support
plate.

9. CONSULT THE STEPS FOR CLOSING THE

INTERNAL PARTS OF THE DEVICE (Par. 6.2)

At the end of the operation, close properly:

• Solenoid valve support plate
• Vertical cover by fixing the two screws
• Front compartment

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10. Turn on the injector, access the

maintenance area and start "Cycle 1"
from the Test area. Then start the CHECK-
UP test to check that there are no leaks
following the replacement of the bags.

11. Make sure the injection bag is empty.

Then start the compressor by first clicking
the PRESS button and setting a value
equal to 500 mmHg, then click the ON
button and stop the compressor by
clicking the OFF button after about 5
seconds of activity. Then click the UPDATE
button on the Sp (Pressurized Bags)
sensor to monitor the pressure value
inside the Pressurized Bags. Then focus
your attention on the Sp (Pressurized Bag)
value shown in the image to the side and
allow the pressure to stabilize for 1
minute. At the end of the stabilizing
minute, start a 1-minute monitoring
period, verifying that the pressure in the
Pressure Bags (Sp Sensor) does not drop
more than 10 mmHg from the start of
monitoring.
12. Switch off the injector and start it
normally by performing at least 5
injections by testing different
combinations of parameters (volume /
pressure) to verify that the injector does
not present operating errors.

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CO2 CYLINDER REPLACEMENT

There is no real maintenance of the CO2 cylinder except for its filling once it has run out. To do
this, you can replace the cylinder with a new one or refill the empty cylinder. The injector indicates
an estimate of the % of CO2 still inside. The reading is provided to the user via the graphical
interface.

SERVICE RESPONSIBLE FOR FILLING THE CO2 CYLINDER

The loading of the cylinder with medical CO2 gas is carried out by the service in charge of medical
gas management at the hospital where the Angiodroid The CO₂ Injector has been installed. The
technical staff is responsible for the correct loading of the cylinder with medical CO 2 gas with a
purity level of 2.5 (i.e. 99.5%) according to the specifications indicated in the technical data sheet
attached to this Manual. The cylinder inside the Angiodroid The CO₂ Injector has a capacity of 2
liters and must be loaded with 1,5 kg of medical CO2 at a pressure of 60 bar considering an
ambient temperature of 20°.

Below are the instructions for the replacement of the cylinder inside the Angiodroid
The CO₂ Injector.

1. CONSULT THE STEPS TO OPEN THE

INTERNAL PARTS OF THE DEVICE (Par. 6.1)

• Open the injector compartment

• Lift the vertical cover
• Lift the solenoid valve support plate
• Lock the solenoid valves support
plate with the appropriate locking
rod

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2. TIP: disconnect the luer-lock

connector from the syringe (shown
in the figure above) to avoid
damaging the tube and this
connected during the removal of
the cylinder.

NB: CLOSE THE CYLINDER VALVE.

3. Disconnect the cylinder delivery

hose from the pressure regulator
and insert it into the EV1 Valve. Use
the flying super rapid joint fitting
shown in the figure. At the time of
disconnection, you will hear the
venting of the gas that was present
inside the pressure reducer. Please
do not be alarmed as this is an inert
and harmless CO2 gas.

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4. Disconnect the CN2 steering wheel

connector from the BUTTONS
electronic board (shown in the
figure). The CN2 connector is
connected to the electric cables of
the pressure reducer, so it MUST be
disconnected before removing the
cylinder.

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4*. If the cable coming out from the

electrical contact of the high-
pressure gauge of the gear unit is
wired in the manner shown in the
figure, simply disconnect the two
connectors. In this way it is possible
to isolate the cylinder and the
pressure regulator from the
electronic boards, without having to
disconnect the 6-pole Phoenix
connector shown in the previous
point.

5. Then use the 2 fixing screws of the

metal clamps (shown in the figure)
to loosen the grip on the cylinder.

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6. At this point the body "Cylinder +

Pressure regulator" (shown in the
figure) will be completely
detachable from the rest of the
machine. Slowly lift the body
"Cylinder + Pressure regulator"
taking care not to impact against
the valves positioned on the
solenoid valve support plate.

7. Once extracted, place the body

“Cylinder + Pressure Reducer” on
the ground. Hold the cylinder firmly
and use the wrench shown in the
figure of size 36” to disconnect the
pressure regulator from the
cylinder, acting on the nut of the
regulator.

8. Install the new medical CO2

cylinder by retracing the previous
steps backwards.

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8* In the case of pressure regulator with

connection complying with
standards ABNT 209-1 or CGA-320
(Brazil and South Korea) follow the
steps listed below for removal and
installation:
1. Take the pressure regulator and the
associated sealing o-ring;
2. Apply the sealing o-ring to the inlet
connection of the pressure regulator
(NB. Keep the o-ring as clean as
possible to prevent debris from
entering the pressure regulator);
3. Install the pressure regulator to the
ABNT 209-1 and CGA-320 compliant
outlet valve cylinder using a 36"
wrench.

8* In case of pressure regulator with

connection in accordance with CGA-
940 (Hong Kong) follow the steps 1
listed below for removal and
installation:
1. Take the pressure regulator with
connection complying with CGA-940
standard.
2. Connect the pressure regulator to a
cylinder with an outlet valve
conforming to CGA-940, paying
attention to correctly align the male-
female profiles.

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3. Fix the pressure regulator by turning 2

the knob clockwise (during this phase
pay particular attention to the correct
flattening of the o-ring between
regulator and cylinder)

9. Reconnect the syringe luer-lock

connector, that was previously
disconnected.

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10. Reconnect the output hose from the

pressure regulator to the super
rapid joint fitting of the EV1
solenoid valve and the Phoenix
connector on the button board
(point 4) or the black connector of
the pressure regulator wiring
harness (point 4*).

11. Then gently open the cylinder valve,

and check that the primary pressure
gauge (red arrow) indicates a
pressure between 50 and 60 bar,
while the secondary pressure gauge
(blue arrow) indicates a pressure
between 0.4 and 0.7 bar.

12. Test the connection of the tube that

has just connected to EV1: try to
extract it without applying pressure
on the metal ring nut of the
connector. During this test there
must be no gas leak.

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13. Switch on the Angiodroid

The CO₂ Injector, access the SERVICE
/ CYLINDER REFILL area and enter
the volume of the CO2 cylinder in
liters equal to 742 and carry out a
CHECK-UP test.

14. Then turn off the injector and

restart again in user mode by
carrying out at least 5 injections
with different parameters (volume /
pressure) checking that there are no
operating errors.

The technical data sheets of the medical CO2 gas used, and the cylinder installed are shown
below:

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10 Programming Procedure for the Firmware on the Actuator Board, Control Board
and Button Board

1. Disconnect the power cable of the touchscreen monitor with the machine off. Act on the clip
shown in the figure to disconnect the blue / brown cables.
IB 520F – Windows CE Board

IB 898 – Windows 7 Board

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2. Power up the Angiodroid injector using the power button.

3. Connect the Angiodroid programmer (image below) to the PC via a USB-Serial adapter (the PC
must recognize the programmer as a serial port), and the white 6-pole connector to the
complementary connector on the electronic board whose firmware you want to update .

Each of the 3 electronic boards (Actuators, Control, and Buttons) has a connector of this type (next
picture).

NB: To make the connector of the Actuators board accessible (which is covered by the push-
buttons board) a bridge has been installed that exits externally as shown in the figure below.

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6-pin Connector
Buttons Board

6-pin Connector
Control Board

6-pin connector
Actuators Board

4. Reset the interface card with the switch and move the switch to position P (programming),
repeat the reset.

5. Start the programming management program M16Progr.exe (figure below) and select the
correct COM port to which the programmer is connected.

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6. In this screen shown above, click the button called "Add MOT". A window will open where
you will need to click on "Search" to select the path to the folder where the firmware file to
upload is located.

Then select the file related to the electronic board you want to program and press OK. The
name of the selected file will be indicated in the upper left part, as shown in the figure
below. The correct files to select are contained in the firmware folder of the technical file:
• attuatori.mot
• controllo.mot
• pulsanti.mot.

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7. Now, on the main screen, select the .mot file indicated in the space at the top left with the
left mouse button (the label with the name must light blue as shown in the image above).
Then press "Program Cycle” and wait for the end of the firmware loading process. The
program will automatically erase the microcontroller first and then start the actual
firmware loading.
At the end of the process, the correct firmware loading will be indicated in the white space
at the bottom of the screen.

8. At the end of the process exit the application, disconnect the programming interface from
the CN17 connector.

9. Reconnect the PC power supply.

NB: The firmware folder will only and exclusively contain the current version of the files (i.e. the
latest release). The file called "buildnumber.h" contains the firmware version number.

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11 Setting the PC Card IB898 Bios

If you need to reset the settings on the IB898 card, please follow the instructions below.

Required:

→ IB898 card complete with monitor

→ Compact Flash 128M or higher
→ USB Keyboard
→ USB pen with SetBiosIB898.zip unzipped package

PC interface diagram:

Setting:

1) Connect the USB keyboard to a USB port on the interface.

2) Turn on the device and press the CANC button on the keyboard to enter the system BIOS.
3) Once in the BIOS, use the directional arrows on the keyboard to go to the Boot section,
shown in the image below.

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4) Select Boot mode select, then press enter and select UEFI (the only alternative to LEGACY,
default option).

5) Go to Save & Exit panel

6) Select the Save Changes and Exit option

7) After verifying that the PC has exited the BIOS, turn off the device.

8) Connect the USB stick with the IB898 configuration file inside.

9) Turn on the device. The PC automatically detects the contents of the USB stick and starts
an automatic setup procedure lasting about 5 minutes. At the end of the process the PC
restarts according to the default settings.

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12 Programming procedure for the motor drive

1. Turn on the computer and power the machine.
2. Connect the UDP30 programming interface card to the DUP connector on the drive card
and the USB cable to the computer.
3. Start the UDPcommander 1.51 (Lam Technologies) software from the PC.

4. Click on "Connect" and then "Change drive configuration". The following screen will
appear:

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5. Click on "Field BUS configuration" and set the parameters as in the following screen:

6. Click on "Open application program" and select the .dup file to load. Then click on "Compile
application program" and then “Download the application program into the drive”.

7. Wait until the program is downloaded in the tab and then click on “Start the application
program execution”.
8. Click on " Close the program" and disconnect the tab and the connection cables.

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ATTENTION

The inspection may only be carried out by technical personnel authorized by the
manufacturer after a training course.
The manufacturer will not be responsible for:
• improper use of the machine other than its intended use,
• damage to the machine, the patient and the operator caused by incorrect installation
and/or maintenance and the use of procedures other than those indicated,
• electrical and/or mechanical modifications made during or after installation other
than those indicated in the service manual,
• the use of non-original spare parts.

13 Positioning of grounding point symbols

The ground connection clamps inside the device must be indicated with the appropriate IEC
60417-5019 symbol at the following points:

Clamp1
Clamp 2

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Clamp 3

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