ARDO Amelie3 - 1 ServiceInstructions - en 08 - 2011
ARDO Amelie3 - 1 ServiceInstructions - en 08 - 2011
175A
08 / 2011
Incubator
Service Instructions
Copyright 2009
Ardo medical AG Gewerbestrasse 19 6314 Unterägeri Switzerland
T +41 (0)41 754 70 70 F +41 (0)41 754 70 71 info@ardo.ch www.ardo.ch
TABLE OF CONTENTS
Safety Instructions 5
Electrical Connection 6
Leakage Current 6
Humidity 7
INTRODUCTION 8
Intended use 8
GENERAL MAINTENANCE 8
Yearly Maintenance 8
Precautionary Check 9
Maintenance 11
Install/ replace Oxygen Sensor 11
Battery 23
Replace battery 23
Battery LED 24
Battery voltage 24
Alarm battery faulty 24
Heaters 29
Replace Air Heater 29
Replace Humidity Heater 30
SERVICE MENU 66
MENU PRINTING 72
Serial Interface 72
Wiring diagram 86
TECHNICAL INFORMATION 88
Spare parts 95
Measuring devices 96
PERSONAL NOTES 97
Mechanics /Statics
- The upper part of the incubator must be properly fitted to the mobile stand using the screws supplied.
In the case of faulty assembly, the upper part of the incubator is displaced from its mounting by lateral
impacts or can even fall to the ground by displacement of the centre of gravity when the hood is
opened.
- Never place any objects under the mobile stand that could cause the mobile stand to lift and thus
impair the stability of the incubator.
- The castor brakes of the mobile stand must always be clamped in order to ensure a stable position.
- If the incubator is parked on a sloping surface, attention must be paid so that the parking brakes on
the front castors are in the direction of the slope and are locked.
- If the incubator is in a tilted position of more than 10° inclination, there is a danger of tipping over!
- If mechanical components of the incubator, such as arm access openings, doors, etc. have become
loose, or if other mechanical problems arise, such defects must be immediately repaired.
Change of location
- Ensure that all accessory parts are firmly fixed in their correct positions.
- Ensure that the water reservoir for distilled water is emptied before the incubator is moved. In this way
it will be avoided that water spills out of the reservoir and the incubator is no longer operational.
- Ensure that any cables and tubes which are not to be moved with the incubator are no longer
connected to the incubator.
- Prior to a change in location it is always safest if the electrical height adjustment of the mobile stand
and the lying surface of the patient in the incubator are adjusted to the lowest level. (Shift the center of
gravity lower down).
- When moving, do not push or pull on the hood but on the equipment frame or on the equipment rails;
the hood is hinged upwards and not firmly connected with the equipment frame.
- For moving the incubator, two sufficiently strong persons should be available so that any danger of
injuries or damage is avoided.
Operating Conditions
- Do not operate the incubator and do not carry out any measurements of temperature if one of the
ranges approved in the specifications, and in particular the temperature ranges, cannot be maintained.
Sensor box
Never change the sensor box from one incubator to another incubator!
The sensor box is calibrated together with its controller.
The serial number of the sensor box must comply with the serial number
on the mobile stand.
In case the serial numbers are different, the incubator must not be operated!
The patient leakage currents of the connected equipment add together and,
depending on the configuration, can be too high.
Leakage Current
Humidity
- When refilling the water reservoir, use distilled water exclusively. Normal tap water contains micro-
organisms that can multiply unchecked in the reservoir or in the humidifier. Sterile water is not an
alternative for distilled water.
- At higher air humidity (normally over 80% RH, depending on the environment) condensed water can
form on the inner walls of the hood.
- If there is a large difference between the air humidity of the surroundings and the set air humidity in
the incubator, it can be difficult to attain the set value.
Amelie
Oxygen supply through a non-regulated inlet. Oxygen must be supplied via an optional flow-meter. There
is a display for the effective O2 value in volume percent.
Amelie star
Oxygen supply through a regulated inlet (O2-servo-relay). The setting of the desired O2 value in volume
percent and the display of the effective O2 value are both available.
Intended use
The intensive care incubators Amelie and Amelie star are used in the treatment and care of premature
babies and newborns in life-threatening situations in a clinical environment.
GENERAL MAINTENANCE
Not complying with the checks can endanger the patient by parts not functioning correctly!
Not complying with the cleaning instructions can endanger the patient through possible contamination!
Yearly Maintenance
The user is obliged to have the incubator serviced by trained technical personnel at least once a year.
If service is required, please contact the manufacturers or their official representative.
With regard to inspection activities, these persons are not permitted to be subject to
any instructions.
Before switching on
SKIN SENSOR
- Check cable and plug for cracks and breakage
SENSOR BOX
- Check housing for cracks and breakage
- Sockets are optically all right; the plugs can be plugged and unplugged
- connect skin sensors 1 and 2 (for subsequent display check)
MATTRESS BASE
- Check handles to incline the bed (Trendelenbourg) for free movement
- Open front door, test mattress base for correct fitting, must not tip when being pulled out
- Check X-ray tray for free movement
1)
- Check connection cable and plug of scales for cracks and breakage
1)
ACCESSORIES
- Check monitor tray for correct mounting
- Check infusion rod for correct mounting
OXYGEN SYSTEM
- Check non-regulated oxygen inlet for tight fitting and for damage
1)
- Check regulated oxygen inlet for tight fitting and for damage
- Check hose system in the incubator for cracks and damage
MOBILE STAND
- Wheels must turn and steer
- Wheels must be firmly connected to the mobile stand and must not be loose
- Parking brakes must work properly
1)
- Check electrical height adjustment for correct working, (Caution! No objects in the area
of the stroke). The electrical height adjustment is maintenance-free.
- Inspect foot switches at the front and back for firm seating, cracks and breakage
and check function.
1)
Optional accessories
Power cord
Controller display
System is self checking . . . . - After switching on, a short alarm signal is heard
and all lamps light up as a function check
RAM of main MCU: passed (including the LED on the sensor box)
SRAM: passed
Real Time Clock: passed - The display shows the ARDO logo and the
EEPROM: passed software version
Communication: passed - Afterwards, the self test procedure is displayed
and the display subsequently changes to the
normal mode
If an error occurs during the self testing procedure, an acoustic alarm is activated and the error
is indicated in text on the display.
O2 % Note:
In the case of Amelie
21 without regulated oxygen,
the O2 display without Set is
indicated.
Maintenance
In the original equipment the oxygen sensors have to be installed in the sensor box, or in the case of
used sensors, these have to be replaced.
In the sensor box two connections for O2 sensors have been made ready.
AMELIE: Sensor 1 displays the actual value.
AMELIE STAR: Sensor 1 is utilized for regulating the O2 concentration over the O2-servo-relay. Sensor 2
displays the actual value.
Life time
An oxygen sensor is subject to wear independent of the length of time that the unit is switched on, but as
a function of the temperature and the oxygen partial pressure on the gas inlet surface of the sensor.
The sensor must be replaced if during the calibration of the values 21% O2 or 100% O2 are not reached or
if the displayed measured values do not seem plausible.
Note:
The placing of which sensor is placed in which opening
only plays a subordinate role.
yellow / black = Sensor 2 = AMELIE STAR display
green / black = Sensor 1 = AMELIE STAR O2-control
green / black = Sensor 1 = AMELIE display
Accuracy of measurements
A comparative measurement with a calibrated O2-analyzer at an O2-concentration of 45% (stabilized)
must indicate 45% ± 3 on the display of the incubator controller.
At the regulated O2-inlet oxygen is fed via an installed pressure regulator to a 12VDC valve. This valve is
regulated by the incubator controller. This regulated flow of oxygen is fed via the passive pneumatic
regulator to the fan wheel. In case of a malfunction or power failure the 12VDC relay for the O2-servo-
control is switched to power-off and thus closed.
Servo-controlled O2-Inlet
The maximum permitted inlet pressure for the O2-servo inlet is 1MPa (10 bar).
If this value is exceeded, the function of the pressure reducing valve is impaired.
The outlet pressure of the installed pressure reducing valve is set by the
manufacturer to a maximum permissible value of 0.4MPa (4 bar).
Exceeding this value can lead to damage to the pneumatic regulator.
Non-regulated O2-Inlet
The maximum permitted inlet pressure for the non-regulated O2-inlet is 0.4MPa (4bar).
Exceeding this value can lead to damage to the pneumatic regulator.
Remark:
The maximum permissible outlet pressure of the pressure regulator has already been set
by the manufacturer to 0.4MPa.
Inlet O2-controlled
Note:
The pressure regulator cannot be adjusted in a pressure-
free state.
Maximum permissible factory setting is 0.4MPa (4bar).
The external hosing connection to the incubator and the connections are to be
inspected for cracks and leak-tightness.
The internal hosing connections and screw threads are to be inspected for cracks
and leak-tightness.
Leaks in the oxygen supply must be made leak-proof; cracked hoses are to be
replaced.
AR10
Pressure regulator
max. 0.4MPa
Control
Signal
VZ 100
O2-Servo-Relay
Passive
Pneumatic Regulator
O2-Output
The pneumatic regulator must be inspected every two years for functionality.
To inspect the functionality the pneumatic regulator has to be dismounted.
In order to have access to the hose system in the pneumatic regulator, the motor unit has to be
dismounted; see section “replace motor”.
Air intake
Retaining screw
- Remove the air filter housing with the two knurled screws on the rear side of the unit.
- Unscrew the retaining screw next to the air intake.
- Remove the 2x retaining screws on the right side of the housing shell.
Pneumatic Regulator
25-30mm
- Lift the upper part of the housing shell on the right side with the aid of the fitting rail.
- Set a distance of approx. 25-30mm with i.e. a piece of wood between the upper and lower shell.
20mm
Sealing surfaces
Type 1
- Open the regulator housing: remove four screws from the cover.
- Carefully remove the cover; do not scratch the sealing surfaces.
- Open the mixing valve: remove four screws from the flange.
- Carefully remove the flange; do not scratch the sealing surfaces.
Sealing surfaces
Type 1
- Slightly press the spindle with the finger; the spindle should slide smoothly and then spring back.
- Loosen the nut from the spindle and inspect the individual parts as follows:
Type 1
a) b)
Sealing surfaces
Type 2
- Open the regulator housing: remove four screws from the cover.
- Carefully remove the cover; do not scratch the sealing surfaces.
Type 2
- Open the mixing valve: remove four screws from the flange.
- Carefully remove the flange; do not scratch the sealing surfaces.
Type 2
- Slightly press the spindle with the finger; the spindle should slide smoothly and then spring back.
- Loosen the nut from the spindle and inspect the individual parts as follows:
a) b) c Type 2
Do not lubricate! Do not use any grease or oil! These parts come into contact
with oxygen and must not be lubricated.
Clean off any dust or dirt with a clean, lint-free cloth.
The serial number of the controller must comply with the serial number
on the sensor box.
In case the serial numbers are different, the incubator must not be operated!
In order to prevent any damage to the unit, only the original replacement batteries
must be used: GP17R8H Ni-MH 8.4V/170mAh.
The battery prescribed by ARDO is protected against short-circuiting.
Replace battery
- Carefully remove the clip from the re-chargeable battery (do not cause a short-circuit
with the + and - poles!)
- Lift the re-chargeable battery from its holder and replace with a new battery of the same type.
Type: GP17R8H Ni-MH 8.4V/170mAh
- Note: Is the voltage on the new battery ≤ 5.5VDC, the new battery has to be charged with
an external battery-charger to a voltage of higher than 5.5VDC.
- Connect the clip to the battery.
Clip
Holder
Functional test
Switch on the controller; the incubator must start in normal mode without any alarm.
Separate the mains connection from the incubator. The Power-LED on the front panel of the controller
must blink and the acoustic alarm must be active for at least 10 minutes.
Battery voltage
During the normal mode it is possible with a key combination to query the present battery voltage.
- Switch on controller.
- Wait until the main menu appears (whether Air or Skin mode is unimportant).
- LED for keyboard lock must no longer be lit up.
DD-MM-YYYY hh:mm
Unit: °C Air
Air Set
Heater
Skin
30.0 30.0
Skin1 Skin2 Humidity
9.6 7.2 O2
Humid. %
Set
45 50
O2 %
Set
21 21
While the keys are being held down, the display in the display area Skin 1 changes from displaying
the temperature to displaying the battery voltage.
Example: 09.6 = Battery voltage 9.6VDC.
During operation the re-chargeable 9V NiMH battery is monitored. If the battery voltage drops below 5.5V,
the alarm “Alarm Error Battery” appears on the display.
The same alarm appears if the battery is not connected or the connection has been interrupted.
Note: If the battery voltage should drop to ≤ 5.5 VDC due to longer storage or non-use of the incubator,
the battery must be charged with an external battery charger to a voltage higher than 5.5 VDC.
Heater cover
Danger of burning
Slide new fan wheel onto the motor spindle as far as the stop and then tighten the knurled nut in the
anticlockwise direction.
If the noise level of the incubator is too high (≥ 50dBA), it should be checked to see whether the fan wheel
can still be freely rotated. A worn bearing in the motor shaft can also lead to an increase in the noise level.
Such a motor with an excessive noise level must be replaced.
Disconnect the unit from the mains supply.
The dismounting of the mattress base and the cover panel is described in the Operating Instructions.
Info: Connection motor to controller, plug J1 pin 3 and 6.
2
3
5
8 7 6
Disconnect plug connections:
1. O2-Servo-Relay (for Amelie star only)
2. Air flow sensor
3. Speed sensor for motor
4. Protective earth ground for motor and air heater
5. Phase / Neutral for air heater and motor
6. Sensor for water level and position switch for water reservoir
7. Protective earth ground for humidifier heater
8. Phase / Neutral for humidifier heater
Dismount motor
c) a) Motor suspension
b) Rubber buffer
c) Motor
- Screw the speed sensor firmly again onto the motor housing in the reverse sequence to that described
above. Make sure that the pulse generator disc does not touch the photoelectric sensor.
- The wiring of the motor capacitor and of the motor supply is to be correspondingly coupled to the new
motor.
- Assemble the motor suspension together with the motor into the motor unit.
In order to replace the air heater, the motor unit has to be dismounted; see section “replace motor”.
In order to replace the humidifier heater, the incubator housing must be dismantled into two parts.
2
3
5
8 7 6
Disconnect plug connections:
1. O2-Servo-Relay (for Amelie star only)
2. Air flow sensor
3. Speed sensor for motor
4. Protective earth ground for motor and air heater
5. Phase / Neutral for air heater and motor
6. Sensor for water level and position switch for water reservoir
7. Protective earth ground for humidifier heater
8. Phase / Neutral for humidifier heater
In order to avoid damage to the Plexiglas hood, two people are necessary for lifting up the hood.
Caution!
b)
Caution!
The sequence of the seals and the
heater insulation shown here is to
be observed during assembling!
Caution!
Ensure that the plugs or the
protective earth ground
respectively are firmly fitted.
Important
Information Since the amount of work involved in replacing the position switch, its seal,
the overtemperature switches, and the sensor contact for water level is the same as
just replacing the humidifier heater, we recommend checking these other electrical
and mechanical parts and if necessary replacing them.
Place the upper housing section onto the lower housing section
Slit
Bumper strip
After replacing the heater or after loosening the fixing screws of the heater, the alignment of the heater
element with the heater device of the water reservoir may have to be readjusted.
Do not apply any lubricant to the heater element or in the heater device bore hole on
the water reservoir!
Lubricants lead to toxic smoke and can cause a fire.
Inserting the controller is easier before the motor unit has been fitted. The wiring of the controller can be
straightened out through the housing opening for the motor unit.
Caution!
When assembling take care that no
wire is trapped between the housing of
the speed controller and the housing
floor (avoidance of faulty wires and
noise transfer).
Mounting the hood is carried out in the reverse order to that described at the beginning of this chapter.
Only distilled water may be used to humidify the incubator. Nevertheless, after prolonged usage of the
humidifier, deposits of calcium carbonate (scale) may build up on the heating device inside the water
reservoir.
The scale deposits may be removed as follows:
Heating device
Humidifier chamber
Do not apply any lubricant to the thread of the heater device on the water reservoir!
Lubricants lead to toxic smoke and can cause a fire.
In order not to promote the deposition of scale on the surfaces, scratches due to
mechanical cleaning must be avoided.
Metal and plastic will be corroded or degraded by scale remover (decalcifier)
that is too aggressive. The manufacturer’s instructions related to this must be
implicitly observed.
All parts that come into contact with scale remover (decalcifier) must be neutralized
by copious flushing with water.
Neutralization prevents toxic vapours in the patient area.
Neutralization prevents unnoticed corrosion in the parts affected.
c) a) Heating device
c) Silicone seal
e) Nut M24x2
a)
The humidifier opening becomes visible after removal of the mattress base and the cover panel.
The seal on the humidifier opening prevents vapour from the humidifier penetrating into the insertion
chamber of the water reservoir.
If the humidifier was in operation shortly before, this region could still be hot.
Check that the seal has no cracks and forms a seal with the cover of the water reservoir.
Frame
Silicone seal
Temperature Measuring
To ensure reproducible measurement of the incubator temperature, the following instructions must be
adhered to:
Operating Conditions
The measurement must be performed at an ambient temperature between 21°C and 26°C and at a
humidity of 30% to 50% RH in the room. Draughts are to be avoided.
Measuring equipment
The temperature measurement must be performed in the middle of the horizontally aligned lying surface.
The vertical distance to the lying surface must be 10cm.
The installation to measure the temperature can be carried out in a simple fashion
with the reference base provided and is also reproducible.
Precision thermometer
Humidity sensor
Skin sensor 1
Skin sensor 2
10cm
Reference base:
Reference base:
Put heat conducting paste in the thermometer support and place in the center of the lying surface.
Precision thermometer:
Guide the thermometer through the drill hole on the hood above the center and into the support on
the reference base.
Skin sensor:
Put heat conducting paste on the contact surface and fix on the reference base close to the
thermometer with cable ties.
Important The size of the measuring device or its sensor may not
negatively influence the air flow in the incubator hood.
The temperature in the incubator must be stable for at least 1 h before the temperature may be read off
the thermometer.
Compare the temperature read on the thermometer with the values indicated on the display.
Humidity Measuring
The humidity measurement can be carried out parallel to the temperature measurement.
Operating conditions
The measurement must be performed at an ambient temperature between 21°C and 26°C and at a
humidity of 30% to 50% RH in the room. Draughts are to be avoided.
Measuring equipment
Depending on the size and the composition of the sensor, it should also be placed in the middle of the
lying surface and 10cm above the lying surface.
Measuring
Operate the incubator in Air mode with humidifier.
The temperature and humidity in the incubator must be stable for at least 1 h before the humidity may be
read off the hygrometer.
Compare the temperature read on the hygrometer with the values indicated on the display.
This function is used for calibrating the weight sensors and is not required in everyday service.
Calibration of the scales is carried out by the technical service department.
Any repairs to the scales are carried out by the manufacturer.
The scales must be checked and possibly calibrated by the technical service
department prior to the initial operation or after repair.
For calibration a precise reference weight of 5000g is necessary.
The accuracy of the scales must be checked by the technical service department
every half year. In case of any deviation the scales must be re-calibrated.
All objects, including the mattress and any dirt, must be removed from the scale pan.
Important: For a precise calibration the scales must be stable at a temperature of 34°C.
Afterwards set the temperature-stabilized scales to zero.
Menu Weight
In order to see the weight and the trend chart in the controller display, select the Weight menu
Select Humidity menu in order to get to the Weight menu.
M AIN MENU
DD-MM-YYYY hh:mm
Air
Air Set
Skin
30.0 30.0
Skin 1 Skin 2 Humidity
Humidity
36.0 --.- O2
Humid. %
Set
45 50
O2 % Green LED
Set Open / Close
t 21 21
- Press Open key, the green LED lights up and access is given to the keys.
- Press Humidity key and the menu Weight appears
DD-MM-YYYY hh:mm
Unit: °C Set
Air Set
Heater
Weight
30.0 30.0
Skin 1 Skin 2 Trend
36.0 --.- Home
Humid. %
Set
45 50
O2 %
Set
t 21 21
DD-MM-YYYY hh:mm
Unit: °C Trend
Air Set
Heater
Calibration
30.0 30.0
Skin 1 Skin 2 Zero
36.0 --.- Home
Humid. %
Set
45 50
O2 %
Set
t 21 21
- Press Trend key; the weight display and the trend appear.
DD-MM-YYYY hh:mm
Unit: °C Times
Air Set
Heater
Delete
30.0 30.0
Skin 1 Skin 2
- Select Home key until the main menu appears, or select another menu.
- Press Close key
MENU WEIGHT
DD-MM-YYYY hh:mm
Unit: °C Set
Air Set
Heater
Weight
30.0 30.0
Skin 1 Skin 2 Trend
36.0 --.- Home
g Weight 7 Days Humid. %
Set
200 45 50
100
O2 %
0 t Set
First: 1234g
100
Last: 4567g 21 21
- Press Open, the green LED lights up and access is given to the keys.
- Press Humidity key and the menu Weight appears
- Press Weight key, the Weight sub menus appear.
DD-MM-YYYY hh:mm
Unit: °C Trend
Air Set
Heater
Cal.
30.0 30.0
Skin 1 Skin 2 Zero
36.0 --.- Home
g Weight 7 Days Humid. %
Set
200 45 50
100
O2 %
0 t Set
First: 1234g
100
Last: 4567g 21 21
- Press zero key, the scales start setting to zero. The following display appears:
DD-MM-YYYY hh:mm
Unit: °C Trend
Air Set
Heater
Cal.
30.0 30.0
Skin 1 Skin 2 Zero
36.0 --.- Home
Humid. %
Set
Weight: 0400g 45 50
O2 %
Please wait . . . 9s Set
21Humid.
21 %
Set
Weight: 0400g 45 50
O2 %
Set
Please wait . . . 8s 21 Humid. %
21 Set
Weight: 0400g 45 50
O2 %
Set
Please wait . . . 7s 21 21
Humid. %
Set
Weight: 0400g 45 50
O2 %
Set
Please wait . . . 0s 21 Humid. %
21 Set
Weight: 0400g 45 50
O2 %
Set
Please wait . . . Humid. %
21 21 Set
Weight: 0000g 45 50
O2 %
Set
21 21
Please note:
After pressing the Zero key the actual zero balancing on the scales is delayed by 10 seconds.
These 10 seconds allows the user to lift up the patient or any objects from the scale pan.
The display must show 0000g +/- 1g when setting to zero, otherwise the zero key must be
once more pressed.
DD-MM-YYYY hh:mm
Unit: °C Air
Air Set
Heater
Skin
30.0 30.0
Skin 1 Skin 2 Humidity
36.0 --.- O2
g Weight 7 Days Humid. %
Set
200 45 50
100
O2 %
0 t Set
First: 1234g
100
Last: 0000g 21 21
The value displayed for the last weighing is now set to zero.
DD-MM-YYYY hh:mm
Unit: °C Trend
Air Set
Heater
Cal.
30.0 30.0
Skin 1 Skin 2 Zero
36.0 --.- Home
Humid. %
Set
Error Zero Setting
(max. 2000g)
45 50
O2 %
Set
21 21
The scales must only be calibrated if during the checking of the scales there is a deviation from the
values given below.
Place the reference weight of 2000g for checking the scale (not for calibration) in the middle of the scale
pan; the display must indicate 2000g +/-5g. If the display is not within the tolerance limits, the scales must
be calibrated.
Place the reference weight in the scale pan in the region of the first of the four fastening screws (weight
sensor); the display must indicate 2000g +/-10g. One after another load the three further sensors with the
reference weight and check the display; the display must indicate 2000g +/-10g (the order is not
significant).
2kg
If one of the sensors deviates from the required value, the manufacturer is to be contacted.
Perform calibration
DD-MM-YYYY hh:mm
Unit: °C Trend
Air Set
Heater
Calibration
30.0 30.0
Skin 1 Skin 2 Zero
36.0 --.- Home
g Weight 7 days Humid. %
Set
200 45 50
100
O2 %
0 t Set
First: 1234g
100
Last: 0000g 21 21
- Press Open, the green LED lights up and access is given to the keys.
- Press Humidity key and the menu Weight appears.
- Press Weight key; the Weight sub menus appear.
After pressing the Calibration key the calibration begins. A further message appears as a precaution.
To cancel the calibration press the key No or do not press any key for 15 seconds. The calibration is not
executed and the previous menu appears.
DD-MM-YYYY hh:mm
Unit: °C Trend
Air Set
Heater
Calibration
30.0 30.0
Skin 1 Haut 2 Zero
36.0 --.- Home
g Weight 7 days Humid. %
Set
200 45 50
100
O2 %
0 t Set
First: 1234g
100
Last: 0000g 21 21
DD-MM-YYYY hh:mm
Unit: °C Yes
Air Heater Set
30.0 30.0
Skin 1 Skin 2
36.0 --.- No
Humid. %
Note! Set
For the calibration it needs
45 50
5000g weight O2 %
Set
are you sure? 21 21
DD-MM-YYYY hh:mm
Unit: °C Trend
Air Set
Heater
Calibration
30.0 30.0
Skin 1 TT-MM-JJJJ Skin 2 Zerohh:mm
Unit: °C
36.0 Luft --.-
Heizung
Home
Set
Diagramm
Kal.
30.0 30.0
Humid. %
Set
Haut 1 Haut 2 Null
Please wait . . . 45 50
36.0 O %
2
--.- Zurück
Set Feuchte %
21 21 Set
45 50
O2 %
Weight: 5000g Set
21 21
The display must show 5000g +/-5g when calibrating, otherwise press the Calibration key once again.
If the tolerance limits of +/-5g cannot be achieved, the scales may no longer be used and the
manufacturer must be contacted.
Place the reference weight of 2000g for checking the scale (not for calibration) in the middle of the scale
pan; the display must indicate 2000g +/-5g. If the display is not within the tolerance limits, the scales must
be calibrated.
Place the reference weight in the scale pan in the region of the first of the four fastening screws (weight
sensor); the display must indicate 2000g +/-10g. One after another load the three further sensors with the
reference weight and check the display; the display must indicate 2000g +/-10g (the order is not
significant).
2kg
If one of the sensors deviates from the required value, the manufacturer is to be contacted.
Alarm Reset
Power
>37°
Battery
Checkout-State of Oxygen
The actual value must be stable over a period of 1 minute to within ±2% O2 of the set value before
oxygen deviation monitoring between the actual value and the set value begins.
Since the keyboard has been unlocked, the above-mentioned Checkout state for temperature, humidity
and O2 is reset. (An opened keyboard considers to be entering a new value). The alarms regarding
temperature, humidity and O2 are switched back to the start of the Check-out state. That means that the
temperature must again be stable to within ± 0.5°C over a period of 10 minutes, before a temperature
deviation alarm can be actuated.
Alarms that indicate a fault in the incubator are, however, immediately activated after the Open / Close
key has been deactivated.
Alarm Description
Alarm lamp (LED) blinks on the controller and an
Power failure acoustic alarm is activated.
(Failure of the AC supply or the internal No message appears on the display.
VCC-supply) The alarm can only be deactivated by switching
off the mains switch on the controller.
- Switch on the unit
Testing> - Switch off mains switch on the mobile stand or
disconnect power cord from the unit
- The internal 9V battery must sustain the alarm for
Result>
at least 10 minutes.
The following alarms appear as text on the display and optical and acoustic alarms are activated.
Deviation below:
- In the Air mode adjust the Set to 37°C
- Wait until the check-out state is active (stable to
±0.5°C over 10 minutes)
- Open front door; at 34°C the alarm is activated
and the heater remains switched on.
- Press alarm reset once; the acoustic alarm is
deactivated and after 4 minutes must again go off.
- Close front door; at 36.8°C the alarm is
automatically cancelled.
Deviation above:
Testing>
- Afterwards in the Air mode adjust the Set to 34°C .
- Wait until the check-out state is active (stable to
±0.5°C over 10 minutes)
- Open the arm access opening and warm with an
electric hair-dryer (not hot!). Allow air to flow into
the hood.
- At 37°C the alarm becomes active and the heater
is switched off.
- Press alarm reset once; the acoustic alarm is
deactivated and after 4 minutes must again go off.
- Shut off the hair-dryer; at 34.2°C the alarm is
automatically cancelled.
Deviation above:
- Wait until the temperature has again risen to 36°C.
- Open the arm access opening and warm with an
electric hair-dryer (not hot!) Allow air to flow into the
hood.
- At 37°C the alarm becomes active and the heater
is switched off.
- Press alarm reset once; the acoustic alarm is
deactivated and after 4 minutes must again go off.
- Shut off the hair-dryer; at 36.2°C the alarm is
automatically cancelled.
More than -1°C = alarm, heater remains switched on.
Result>
More than +1°C = alarm, heater is switched off.
Note:
Graphic 1 and graphic 2, as well as further descriptions for testing over temperature,
are laid out on the following pages.
The display is in the normal mode and the keys are blocked.
The settings for the set temperature have been made corresponding to the over temperature alarm that is
to be tested (air or skin).
DD-MM-YYYY hh:mm
Unit: °C Air
Air Set
Heater
Skin
36.0 36.0
Skin1 Skin 2 Humidity
36.5 36.6 O2
Humid. %
Set
45 50
O2 %
Set
21 21
The Control sensor works as an independent air sensor in the sensor box.
This sensor is continually checked by the Isolated sensor. If there is a difference of ≥0.8°C,
the alarm “Alarm Air Sensor is different from isolated Sensor” is activated.
The other role of the isolated sensor is to activate the alarm in case of over temperature.
The value of the Control sensor must be checked for the over temperature test.
The procedure is as follows for this check:
The Alarm Over Temperature (e.g. 40°C) has just bee n activated.
DD-MM-YYYY hh:mm
Unit: °C Air
Air Heater Set
Skin
39.8
Skin 1 Skin 2 Humidity
38.7 38.9 O2
Humidi. %
Set
DD-MM-YYYY hh:mm
Unit: °C Air
Air Set
Heater
Skin
40.0 45.8
Skin 1 Skin 2 Humidity
9.6 7.2 O2
Humid. %
Set
Note: the values displayed in other display areas are not relevant here. They are described in the
section “Indication of the operating states” in more detail.
Deviation above:
Testing> - Set humidity with Set to 50%RH.
- Wait until the check-out state is active (stable to
±3%RH for 1 minute).
- Open the arm access opening and hold a small
container with hot water close to and underneath
the sensor box. (The fan wheel in the sensor box
draws the water vapor to the humidity sensor).
- At 65%RH the alarm becomes active and the
humidity heater is switched off.
- Press the alarm reset key 1x; the acoustic alarm is
reset and must be again active after 4 minutes.
- Remove the container with hot water from the
hood; at 64.9%RH the alarm is automatically
cancelled.
- Set 65%RH = Alarm at 50%RH; the humidifier
heater remains switched on.
- Set 50%RH = Alarm at 65%RH; the humidifier
Result> heater switches off.
Note: If the humidity of the surroundings is higher
than 50%, the Set humidity for the "deviation below"
test must be selected correspondingly higher.
Alarm O2 Deviation
Deviations of the measured O2-concentration is
(Amelie does not have this alarm, since her O2
greater than ±5% compared to the set value.
is only displayed and there is no O2-controlling).
Deviation below:
- In the Air mode adjust the Set to 34°C.
- Set O2 with Set to 35%O2.
- Wait until the check-out state is active (stable to
±2%O2 for 1 minute).
- Open front door; at 30%O2 the alarm is activated
and the O2- servo-relay remains switched on.
- Press the alarm reset key 1x; the acoustic alarm is
reset and must be again active after 110 seconds.
- Close front door; at 31%O2 the alarm is
automatically cancelled.
Deviation above:
Testing> - Set O2 with Set to 30%O2.
- Wait until the check-out state is active (stable to
±2%O2 for 1 minute).
- Allow additional oxygen to flow into the hood
through the second O2-inlet (non-regulated inlet).
(Or alternatively pass a second O2 hose through
the tube grommet in the hood and allow oxygen to
flow through a flow meter.
- At 35%O2 the alarm is activated and the O2-servo-
relay is switched off.
- Press the alarm reset key 1x; the acoustic alarm is
reset and must be again active after 110 seconds.
- Shut off the additional oxygen; at 34%O2 the alarm
is automatically cancelled.
- Set 35%O2 = Alarm at 30%O2; the Servo-relay for
the oxygen feed remains switched on.
Result>
- Set 30%O2 = Alarm at 35%O2; the Servo-relay for
the oxygen feed is switched off.
In the service menu all the parameters for the controller or, respectively, for the software, are to be found.
Access to the menu is protected with a password.
P AS S W O R D
Technicians trained by Ardo medical AG receive the password during training. In the
service menu settings can be made which could endanger the patient in the event of
lack of knowledge. Thus the appropriate attention should be taken with handling the
password.
- Press Open key, at the same time switch on the mains switch of the controller. + 0 I
1
2
3
4
Password input:
******
Password wrong
1 2 3 4 5
Service menu
1 2 3 4 7
Password wrong
With the Cursor key the arrow on the left edge of the screen can be moved to the next menu item.
At the end of the page the Cursor changes to the next page.
After the last menu item the menu item 1 appears again.
- Move the cursor (arrow on the left side of the screen) to the menu item to be modified.
- Upward or Downward key changes the value in the appropriate direction (+ or -).
- Press Save key, and the new value is adopted and saved.
- Press the Back key; the service menu changes over to the self-test and subsequently to the main
menu.
If no input is made over a period of three minutes, the service menu changes back
automatically to the self-test and subsequently to the main menu.
With the Back key (without Save key) the service menu can be left without saving
the modified values.
- Press Data Copy and the modified values will be stored in the memory.
With the function Data Copy the existing contents of the memory will be overwritten.
The values that have been stored with Data Copy can be recalled with the Data Recall key.
The presently indicated values will be overwritten with these recalled values.
Selftest
Main menu
The values programmed in the factory can be recalled with the Factory Set key.
The presently indicated values will be overwritten with these recalled values:
Selftest
Main menu
MENU PRINTING
Serial Interface
The controller is equipped with a serial interface. This RS232 interface offers the possibility of printing out
the most important operating data of the incubator with an optionally supplied printer.
The interface is designed as a Data Terminal Device.
P AS S W O R D
- Press Open key; at the same time switch on the mains switch of the controller. + 0 I
1
2
3
4
Password input:
******
Password wrong
1 2 3 4 5
Print menu
Weight
Print
Menu
Temp.
Exit
The weight data recorded from the incubator scales can be printed out using the Weight menu.
Time limits can be set for the printing range of the past recorded weight data.
Printing range: 1 day to 49 days
Weight
Print
Menu
Temp.
Exit
01 Day/s 02 Day/s
Print
Menu 03 Day/s
Print 04 Day/s
Back
05 Day/s
.
.
.
49 Day/s
01 Day/s
Print
Menu
Print
Back
Data Transfer . . .
1)
Printing error
- Press Print key and the data will be transferred and printed.
1)
Printing Error is displayed when the printing has failed. Check cable connections and the printer.
01 Day/s
Print
Menu
Print
Back
Printout Weight
Printout Explanation
Weight: Fault Weight: Error on the scales
Date: 27-03-2008 12:00 Date: Day-Month-Year Time
Weight: Fault
Date: 27-03-2008 13:00
Weight: 0098 g Weight: stored weight in gram
Date: 27-03-2008 14:00
Weight: 0105 g
Date: 27-03-2008 15:00
Weight: 0108 g
Date: 27-03-2008 16:00
Weight: 0100 g
Date: 27-03-2008 17:00
Weight: 0108 g
Date: 27-03-2008 18:00
Weight: 0110 g
Date: 28-03-2008 10:00
Weight: 0112 g
Date: 28-03-2008 11:00
Weight: 0115 g
Date: 28-03-2008 12:00
***********************************************
Print Date: 27-03-2008 13:22:35
Header
Ardo Infant Incubator
The recorded operating data of the incubator can be printed out with the Temp menu.
Time limits can be set for the printing range of the past recorded operating data.
Printing range: 1 hour to 24 hours
Weight
Print
Menu
Temp.
Exit
01 Hour/s 02 Hour/s
Print
Menu 03 Hour/s
Print 04 Hour/s
Back
05 Hour/s
.
.
.
24 Hour/s
01 Hour/s
Print
Menu
Print
Back
Data Transfer . . .
1)
Printing error
- Press Print key and the data will be transferred and printed.
1)
Printing Error is displayed when the printing has failed.
Check cable connections and the printer.
01 Hour/s
Print
Menu
Print
Back
Printout Explanation
State 2: 0 0 0 0 0 0 0 0
State 1: 1 0 0 0 0 0 0 0 2 lines with Operating States
D: 48% E: 50% F: 21% G: 20%
A: 39.9°C B: 33.7°C C: 34.0°C 2 lines with Actual values and Set Value
State 2: 0 0 0 0 0 0 0 0
State 1: 1 0 0 0 0 0 0 0
D 54% E: 50% F: 21% G: 20%
A: 34.0°C B: 33.7°C C: 34.0°C
Date: 28-03-2008 14:39
State 2: 0 0 0 0 0 0 0 0
State 1: 1 0 0 0 0 0 0 0
D: 56% E: 50% F: 21% G: 20%
A: 34.0°C B: 33.7°C C: 34.0°C
Date: 28-03-2008 14:40
***********************************************
Print Date: 27-03-2008 14:40:35 Header
Ardo Infant Incubator
Description:
A: Air B: Skin C: Temp. Set A: Air Actual B: Skin Actual C: Temp. Set
D: Humidity E: Humidity Set D: Humidity Actual E: Humidity Set
F: O2 G: O2 Set F: O2 Actual G: O2 Set
State 1 (bit. 7~0): State 1: 1 0 0 1 0 0 0 0
Temp. Mode (1=Air, 0=Skin)
Air sensor fault
Skin sensor fault
Humidity sensor fault
O2 sensor fault
Humidity module disable
O2 module disable
O2 control module disable
State 2 (bit. 7~0): State 2: 0 0 0 0 0 0 0 0
System Alarm
Temp. sensor Alarm
Overheat Alarm
Motor Alarm
Temp. Deviation Alarm
Humidity Deviation Alarm
O2 Deviation Alarm
None
Note: 1=Yes, 0=No Code
State 1: 1 0 0 1 0 0 0 0
0 = O2 module is switched on
31-01-2008 16:00
Unit: °C Air
Air Heater Set
Skin
30.0 30.0
To set the date and time, call the menu Date and Time.
Cursor
Save
Set
Back
- Press Set key, after which the setting for date and time is active.
The first two numbers of the date are underscored.
- Press Cursor key to move the cursor to the location which is to be altered.
- Press the Upward or Downward key to change the underscored value.
Cursor
Save
Set
Back
DD-MM-YYYY hh:mm
Unit: °C Air
Air Set
Heater
Skin
30.0 36.7
Skin 1 Skin 2 Humidity
9.6 7.2 O2
Humid. %
Set
45 50
O2 %
Set
21 21
Battery Voltage
Display area Skin 1
Key not pressed: the measured temperature of the Skin 1 sensor is indicated.
Both keys pressed: the measured battery voltage of the installed 9V rechargeable battery is indicated.
INFO: Display 09.6 indicates that the charging voltage on the battery is 9.6VDC.
Motor Speed
Display area Skin 2
Key not pressed: the measured temperature of the Skin 2 sensor is indicated.
Both keys pressed: the measured motor speed is indicated.
INFO: Display 07.2 multiplied by 200 = motor speed (7.2 x 200 = 1440rpm)
O2-Sensor
Display area O2 % (Oxygen)
AMELIE STAR: Keys not pressed; the measured O2 concentration of O2 sensor 2 is indicated.
Both keys pressed: the measured O2 concentration of O2 sensor 1 (servo-control) is indicated.
AMELIE: Keys not pressed; the measured O2 concentration of O2 sensor 1 is indicated. Since there is no
second sensor for servo-control, it continues to indicate the value of the sensor 1.
Keyboard To power
Interface board interface
Main board
Temperature
heater control RS 232 interface
Temperature B
heater control
A
Power board
Skin sensor 1
interface
O2 sensor 2
interface
ADC 2 Client MCU B
Air temp. sensor
interface
Sensor board
Main
Alarm system for failure of temperature heater system
MCU
The guarantee for the incubators Amelie and Amelie star is 2 years from the date of invoice.
General conditions
Ardo medical AG guarantees against material and manufacturing faults for products manufactured by
them. Faulty material will be replaced at no cost during the warranty period, assuming there has been no
improper usage. Excluded are consumables. To ensure the warranty and for correct functioning of the
incubator, the instructions in the Operating Instructions must be adhered to. Only accessories and
replacement parts from Ardo medical AG may be installed and/or utilized. Any right of warranty is waived
if any changes are made by unauthorized persons or changes are made which do not adhere to the valid
IEC/EN standards. There are no warranty claims that exceed the described scope of warranty, such as
liability to consequential damages et cetera.
Service
Please contact the following addresses for service, maintenance or any questions about this product:
Switzerland
Ardo medical AG
Gewerbestrasse 19
CH-6314 Unteraegeri
Switzerland
Tel. +41-(0)41 754 70 70
Fax +41-(0)41 754 70 71
info@ardo.ch
www.ardo.ch
Germany England
Ardo medical GmbH Ardo medical Ltd.
Argelsrieder Feld 10 Unit 1
D-82234 Oberpfaffenhofen Belvedere Trading Estate
Germany Taunton TA1 1BH
Tel. +49 (0)815 390 87 70 United Kingdom
Fax +49 (0)815 390 87 766 Tel. +44 (0)1823 336362
info@ardomedical.de Fax +44 (0)1823 336364
www.ardomedical.de info@ardomedical.co.uk
www.ardomedical.co.uk
International
Authorized Importer
Manufacturer
Ardo medical AG
Gewerbestrasse 19
CH-6314 Unteraegeri
Switzerland
Classification
Protection Class Class I with protective earth ground
Degree of protection BF
Conformity
Directive 93/42/EEC EN 60601-1 / EN60601-1-2 / EN60601-1-4 /
concerning Medical Devices 0123 EN 60601-1-6 / EN60601-2-19 / EN ISO 14971
Operating Conditions
Temperature +20 – +30°C
Relative humidity 30 – 75%RH non condensing
Atmospheric pressure 700 – 1060hPa
Ambient air velocity < 0.3m/s
Storage Conditions up to 15 weeks
Temperature -20 – +55°C
Relative humidity ≤ 93%RH non condensing
Atmospheric pressure 500 – 1060hPa
Storage Conditions from 15 weeks
Temperature +20 – +30°C
Relative humidity 30 – 75%RH non condensing
Atmospheric pressure 700 – 1060hPa
Hood
Height between lying surface and hood 42cm
Opening front and back door [BxH] 85x34cm
Number of doors 2x
Number of arm access openings 5x
Number of iris diaphragms 1x
Number of tube grommets 10x
Noise level < 47dBA
Air velocity over lying surface ≤ 0.12m/s
Carbon dioxide concentration (CO2) ≤ 0.15%
Temperature Control
Air temperature setting range 25.0 – 37.0°C
Air temperature special setting range 37.0 – 39.0°C
Air temperature display range 00.0 – 60.0°C
Skin temperature setting range 34.0 – 37.0°C
Skin temperature special setting range 37.0 – 38.0°C
Skin temperature display range 05.0 – 65.0°C
Pre-warming time < 40 Min
Temperature variability ≤ 0.5°C
Temperature uniformity on level of mattress ≤ 0.8°C
Skin sensor accuracy ≤ 0.3°C
Display resolution 0.1°C
Trend display 2h / 4h / 8h / 12h / 24h
Measuring rate for trend 1 Min
Humidity control
Water reservoir capacity 1500ml
Operating time with 1500ml of water > 20h at 60%RH (ambient 23°C / 45%RH)
Setting range 00 – 90%RH in 1% steps
Display accuracy ± 6%RH (10 – 90% at 20 – 40°C)
Display range 0 – 99%RH
Display resolution 1%
Trend display 2h / 4h / 8h / 12h / 24h
Measuring rate for trend 1 Min
Scales (optional)
Weighing range 100 – 8'000g
Display accuracy ± 10g
Display resolution 1g
Display range 0 – 8000g
Trend display 7 days / 2 – 7 weeks
Measuring rate for trend 1h
Accessories (optional)
Infusion rod 2kg max. load
Monitor tray 8kg max. load
Compartment with two drawers 4kg max. per drawer
Consumables
Spare parts
Measuring devices