User Manual - PC305

Infant Incubator
MEDIX PC 305
U SER M ANUAL
José Arias 293, Villa Lynch

San Martín, 1672 Buenos Aires, Argentina
Tel:+54-11-4754-5555, Fax:+54-11-4754-1713
Catalogue number: 72525H
©2007,MEDIX I.C.S.A
INFANT INCUBATOR MEDIX PC-305
VOLTAGE 220/240 V~– 50/60 Hz

(110/127 V~ – 60/50 Hz) on customer’s request
others: specify
POWER 1.25A @ 220/240 V~
2.5A @ 110/127V~
CLASSIFICATION ACCORDING TO IEC-60601-1 / IEC 60601-2-19 STANDARD
ELECTRIC PROTECTION CLASS I
PROTECTION AGAINST LIQUID IPX0

PRESENCE
APPLICABLE PART
TYPE B
EQUIPMENT NOT SUITABLE FOR USE IN THE PRESENCE OF FLAMMABLE ANAESTHETIC

MIXTURE WITH AIR, OXYGEN OR NITROUS OXIDE.
PC-305 WITH OPTIO NAL ACCESSORIES

T ABLE O F C ONTENTS
User Warning .................................................................................................................................................. 1
Limited Warranty............................................................................................................................................ 1
Technical Assistance....................................................................................................................................... 1
Spare parts provision – Useful life.................................................................................................................. 1
CE Mark.......................................................................................................................................................... 1
FDA 510(k) ..................................................................................................................................................... 1
Definition for Warning, Caution and Note...................................................................................................... 2
Customer Service ............................................................................................................................................ 2
Legal Representative for CE ........................................................................................................................... 2
Summary of warnings, cautions and notes...................................................................................................... 3
Used Symbols ............................................................................................................................................... 10
Warning Labels Fixed to the Equipment....................................................................................................... 12
Equipment Identification............................................................................................................................... 14
1. Introduction ........................................................................................................................................15
1.1 Characteristics................................................................................................................................. 15
1.2 Basic Equipment ............................................................................................................................. 16
1.3 Cabinet Stands ................................................................................................................................ 17
1.4 Optional Accessories ...................................................................................................................... 19
1.5 Consumables/Replacement parts .................................................................................................... 22
1.6 Technical and Functional Specifications ........................................................................................ 23
1.6.1 Technical Specifications ............................................................................................... 23
1.6.2 Functioning ..................................................................................................................... 26
1.7 Description of different access to incubator and auxiliary elements............................................... 27
1.7.1 Standard Access ............................................................................................................ 27
1.7.1.1 General Access................................................................................................ 27
1.7.1.2 Access through Intensive Care Door ............................................................ 27
1.7.1.3 Access through Automatic Ports ................................................................... 28
1.7.1.4 Minor Access Routes ...................................................................................... 29
1.7.1.5 Iris port .............................................................................................................. 29
1.8 Auxiliary Elements ......................................................................................................................... 30
1.8.1 Tilting Mechanism.......................................................................................................................... 30
1.8.2 Incorporated X-Ray Tray................................................................................................................ 30
1.9 Other Additional Equipment........................................................................................................... 30
1.9.1 Aspiration system........................................................................................................... 31
1.9.2 Weighing scale- MEDIX DIA-01................................................................................... 31
1.9.3 Electronic weighing scale WS-1 .................................................................................. 31
1.9.4 Aspiration and reanimation system ............................................................................. 31
1.9.5 Oxygen concentration and cardiac rate monitor ....................................................... 31
1.9.6 Oxygen concentration monitor (fraction of inspired oxygen) .................................. 31
1.9.7 Additional O2 or air tubes.............................................................................................. 32
1.9.8 Energy module TA-04 ................................................................................................... 32
1.9.9 MEDIX Phototherapy..................................................................................................... 32
1.9.10 Tension Stabilizer ............................................................................................ 32
2. Unpacking and Assembly ...................................................................................................................33

2.1 Installation Instructions.................................................................................................................... 33
i
3. Functional Description........................................................................................................................ 35
3.1 Essential Performance.....................................................................................................................35
3.2 Operating Modes.............................................................................................................................35
3.2.1 Skin Mode............................................................................................................................35
3.2.2 Air Mode...............................................................................................................................35
3.2.2.1 Air Mode with Electronic Thermometer........................................................................36
3.3 Security Systems .............................................................................................................................36
3.3.1 Air Temperature Alarm ..................................................................................................36
3.3.3 Overheating Alarm (Temperature greater than 39°C) ..............................................38
3.3.4 Air Flow Failure Alarm ...................................................................................................38
3.3.5. Sensor Failure Alarm ........................................................................................................39
3.3.6 Circuit Failure Alarm ......................................................................................................39
3.3.7 Main Power Fault Alarm................................................................................................40
3.3.8 Fresh Air Intake Security System ................................................................................40
3.4 Security – Very Important Warnings ..............................................................................................40
3.5 Comments about Electromagnetic Compatibility ...........................................................................41
3.5.1 Emissions ........................................................................................................................41
3.5.2 Immunity ..........................................................................................................................41
3.5.3 Electrostatic Discharge..................................................................................................42
3.5.4 Bibliography ....................................................................................................................42
4. Command Module Description ........................................................................................................... 43

4.1 Indicators and Front Panel Controls................................................................................................43
4.2 Side Panel Controls and Connectors ...............................................................................................46
5. Operating Instructions ........................................................................................................................ 47

5.1 Air Mode .........................................................................................................................................49
5.2 Skin Mode.......................................................................................................................................50
5.3 Important Recommendations for the Use of Temperature Sensors.................................................50
5.4 Air Mode with Electronic Thermometer .........................................................................................51
5.5 Instructions for Supplying Oxygen .................................................................................................51
5.5.1 Oxygen Connection ......................................................................................................52
5.5.2 Oxygen Supply ...............................................................................................................52
5.5.3 Very Important Warnings ..............................................................................................53
5.6 Instructions for Use of Humidifiers ................................................................................................54
3. Relative Humidity Control Unit ...............................................................................................55
5.6.2 Hygrometer for Measurement of Relative Humidity.................................................56
5.7 Functional Checking Procedure ......................................................................................................56
6. Troubleshooting ................................................................................................................................. 59
6.1 Skin Temperature Probe..................................................................................................................59
6.1.1 Probe Type......................................................................................................................59
6.1.2 Sensor Problems............................................................................................................60
6.2 Alarms .....................................................................................................................................................60
7. Hygiene and Maintenance.................................................................................................................. 63

Recommended products for cleaning and disinfection..................................................................................63
7.1 Hygiene of Power Unit....................................................................................................................64
7.2 Hygiene of Infant’s Compartment .................................................................................................. 66
7.3 Changing Air Filter......................................................................................................................... 69
7.4 Cleaning of Oxygen Filter................................................................................................................... 69
7.5 Power Unit Maintenance................................................................................................................. 69
7.6 Routine Maintenance Plan .............................................................................................................. 70
Annex 1: Optional Accessory MEDIX TA-04.................................................................................71

Power module TA-04.................................................................................................................................... 71
TECHNICAL SPECIFICATOINS: MODULE TA-04:................................................................................ 71
Autonomy ..................................................................................................................................................... 71
Battery Operation Condition ......................................................................................................................... 72
TA-04 Battery Inverter/Charger Panel .......................................................................................................... 72
Main Connections ......................................................................................................................................... 73
Connection to emergency transport’s battery:.............................................................................................. 74
User Warning
The information contained in this document offers the user proper and detailed
information for an easy installation, use, maintenance and spare parts request of this
equipment. This manual has been updated and its contents are exact to the date of
publishing or revision. Nevertheless, there is no warranty that this document does not
contain mistakes.
Limited Warranty
MEDIX I.C.S.A. warrants that every new device is free from defective workmanship and
materials for normal use and functioning for a period of 1 (one) year from the shipping
date.
This warranty does not cover damage by misuse nor disposables/consumables i.e. filters,
sensors, etc.
The Company warrants at its option either repair or replace the defective products during
the warranty period.
This warranty does not apply to any product modified without MEDIX I.C.S.A. written
consent, and MEDIX I.C.S.A. will not be responsible, directly or indirectly, for any damage
or injury. This warranty is not transferable.
Technical Assistance
During the warranty period MEDIX I.C.S.A. equipment repairing must be carried out at
authorized repairing centers. If the equipment needs repairing, contact your local dealer
or MEDIX I.C.S.A. Technical Department. Before calling please have model and serial
numbers at hand.
If shipping is necessary, pack the equipment and all its accessories carefully, in order to
avoid damage during transportation.
Spare parts provision – Useful life

MEDIX I.C.S.A. guarantees original parts and spare parts provision during 10 (ten) years
from the production of this equipment.
CE Mark
FDA 510(k)
FDA 510(k) Premarket approval Nr.920049 (Food and Drug Administration – USA)
1
Definition for Warning, Caution and Note
In the user instructions the words “Warning”, “Caution” and “Note”, have a special
meaning. The meanings of these words as follows:
! WARNING
Alerts about the possibility of injury for yourself or other people.
CAUTION
Means the possibility of damage to the equipment or to other property.
NOTE
Indicates interesting items for a more efficient or convenient use.
Customer Service
In case of any doubt or request concerning this equipment safety and operation, contact:
MEDIX- I.C.S.A., Jose Arias 293, (1672) Villa Lynch, Buenos Aires, Argentina,
Tel. -+54-11-4754-5555, Fax: +54-11-4754-1713,
E-mail: [email protected]
Legal Representative for CE

MEDIX I.C.S.A. Legal Representative for the Economic European Community (Medical Devices Directive 93/42
EEC):
Hispamerica S.L., c/Puerto Canencia 21, 28.935 Mostoles, Madrid, Spain.
CIF B-82101643
2
Summary of warnings, cautions and notes
Before using the PC-305 incubator, it is recommended to read carefully the following
WARNINGS, CAUTIONS and NOTES, which are contained in this manual.
! WARNING
It is advisable to change the internal battery pack every 2 years for the safe functioning of
the incubator. Contact your Authorized Technical Service.
Equipment maintenance, installation and/or repair must be carried out only by qualified
technical staff. Refer to the Technical Service Manual for repairing or spare parts request.
To slide out the mattress, the tilting mechanism must be in horizontal position.
Use hand port sleeves and iris sleeves while the incubator is functioning so as to protect the
infant.
Although the equipment has wheels it is recommended not to move it while a patient is
under treatment.
Never leave the baby unattended while the intensive care door, hand ports or iris ports are
open
The manufacturer assumes responsibility concerning safety, reliability and functioning of the
equipment if:
1) Installation, modification or repairing tasks are carried out by MEDIX I.C.S.A.
authorized technical service staff, using elements, spare parts or replacement parts
exclusively supplied by MEDIX I.C.S.A..
2) Electric installation and its corresponding authorization respond to local safety
standards.
3) The equipment is operated according to the operating instructions described in this
manual.
The power supply cable must be connected to a proper socket with ground connection. Do
not use adapter plugs or extension cables.
Refer to SECTION 5 of this manual before turning on the incubator.
This equipment is not suitable to be used in presence of anaesthetic gases.
Before turning on the equipment, check all the packing protecting material has been
removed, including the mattress protecting plastic.
MEDICAL ELECTRICAL EQUIPMENT need special precautions regarding EMC and need to
be installed and put into service according to EMC information provided in user and technical
service manuals.
3
The air temperature sensor located on the acrylic canopy (right lateral) is calibrated in factory
for each incubator separately. Interchanging canopies will require a calibration procedure as
described in Technical Service Manual.
In SKIN and AIR modes the control temperature must be determined by the CLINICIAN
according to the infant’s weight, age and general conditions.
When an overheating alarm condition appears the equipment will not function properly until
the overheating failure is fixed. It is recommended to contact the AUTHORIZED
TECHNICAL SERVICE.
When an air flow failure alarm condition appears the equipment cannot function properly
until the air flow failure is fixed. It is advisable to contact the AUTHORIZED TECHNICAL
SERVICE.
When a circuit failure alarm activates, it is recommended to turn the equipment off and
contact the AUTHORIZED TECHNICAL SERVICE.
The use of oxygen increases the equipment risk of fire.
Small quantities of flammable agents like alcohol inside the incubator, increases risk of fire
in presence of oxygen.
Avoid direct sunlight, radiant power sources and cold drafts since these factors may alter
the incubator’s normal functioning and even activate alarms.
Periodically check the patient’s temperature and the functioning of the equipment indicators.
Main connection cables must be connected to a safe socket with ground connection. Do not
use extension cables nor adapters.
Make sure that the auxiliary equipment connected to the patient is electrically safe.
Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL

EQUIPMENT.
Pins of connectors identified with ESD warning symbol should not be touched and
connections should not be made to these connectors unless ESD precautionary procedures
*
are used.
There are two reasons why the permanent attention of qualified medical staff is required
when there is a patient in the incubator:
1. Some malfunctioning situations require immediate corrective actions.
2. One alarm or a combination of alarms does not ensure a total alert of some or all the
malfunctioning situations of the incubator system.
4
The incubator must be operated only by properly trained staff and under the command of
qualified medical staff familiar with whom the risks and benefits on use of incubators is
known.
For infant’s safety do not leave them unattended while the intensive care door or the hand
ports of the incubator are open.
Do not raise both sides of the mattress with the tilting mechanism.
Do not raise the hood with an infant in the incubator. If tubing or leads are connected to the
infant it could result in harm. All necessary access to the infant can be achieved by means
of the front door and hand ports.
When the doors are left open the temperature over the mattress may fall under the set level.
When one or all the doors are left open the air temperature display will be inaccurate.
Do not place the incubator under direct sunlight or close to any other radiant heat source.
External heat sources may cause high inner temperatures that may overheat the infant.
Phototherapy units placed too close to the incubator may affect the hood walls’ temperature,
the inner temperature and the infant’s skin temperature.
This equipment is not designed to function in explosive atmospheres or in the presence of

flammable anaesthetics. Its use in such environments may represent an explosion danger.
Do not place supports, toys, sheets, nappies, pillows, etc. This may affect the correlation
between the incubator temperature and the patient’s skin temperature. The use of
accessories inside the incubator may alter the air flow parameters or affect the temperature
uniformity, the correlation of the variability of the incubator temperature reading and the
temperature in the center of the mattress and the infant’s skin temperature.
Do not place or hang any material or object on the air sensor located at the bottom right side
of the incubator compartment base. This may cause incorrect readings and badly affect the
unit functioning.
When X-Rays are taken through the hood, take into account that the hole for the hammock
weighing scale in the upper part of the acrylic hood can be shown in the X-Ray as a
radiolucent shadow.
Set the brakes on the wheels when the incubator is functioning.
Check the mains power supply socket has its respective ground connection.
The functioning mode and the control temperature must be determined by the clinician for
each infant according to their weight, age and general conditions. The use of the equipment
without the supervision of qualified staff may cause serious damage to the patient’s health.
The rectal temperature sensors (catalogue number DIA-14) must be used only to indicate
and not to control the infant’s temperature.
5
The only sensors to be used must be the ones supplied by MEDIX since the measurement
circuit is designed specifically for these sensors and within strict margins of tolerance.
The use of a different sensor will cause the incorrect functioning of the incubator or what is
even more dangerous, it may indicate wrong temperature readings that will make the
incubator work with inadequate temperature values.
MEDIX DIR-10 sensors (skin – reusable) and MEDIX DIR-30 sensors (skin – disposable)
are both of high precision and perfectly interchangeable. Temperature sensors are fragile
and expensive elements. Care is required in their use and maintenance.
Whenever oxygen is administered to the incubator, the resulting concentration must be

measured with an O2 duly calibrated concentration analyzer.
The values indicated in the tables are reference parameters. In all the cases, the oxygen
concentration level must be checked with an O2 analyzer duly calibrated. The oxygen
partial pressure must be periodically monitored as prescribed by the specialist clinician or
hospital protocol.
Oxygen administration can increase noise level inside the incubator.
The presence of oxygen in the air considerably increases the flammability of all materials.
Remember flames or sparks can be caused by other equipment. All equipment used must
be in a good checked condition.
In case of accident, immediately stop the oxygen supply and disconnect the incubator from
the main power supply.
Opening the intensive care door or hand ports causes sudden oxygen concentration falls
inside the incubator. This situation may affect the infant. Periodically check proper
functioning of the hand ports latches and gaskets.
Do not place a humidifier in line before the oxygen inlet of the incubator. Humidity may block
the air microfilter (0.5 microns) altering the equipment’s functioning. If you wish to modify the
humidity concentration, please see “5.6 Instructions for Use of Humidifiers ” in this chapter.
The use of oxygen in the incubator must be supervised only by qualified medical staff.
Inappropriate additional oxygen administration has been associated with blindness, brain
damage and death as well as other serious side effects which vary in each patient.
The use of oxygen hoods and the forced injection of oxygen may increase noise level inside
the incubator.
In order to avoid liquid spillage during transport, it is necessary to respect the indicated “max”
and “min” water levels.
6
In order to avoid the spread of bacteria use only distilled and sterilized water. Change the
water at least every 12 hours. Do not leave water in the related reservoir when the incubator
is not in use.
If the environmental temperature in the treatment room is low, the water vapor in the incubator
may condense on the hood walls thus impeding full vision of the interior. This condensation
will not affect the correct functioning of the incubator
Read the Functional Checking Procedure of this manual before operating the incubator. If a
problem is detected during any stage of the Functional Checking Procedure the incubator
must not be used and the AUTHORIZED TECHNICAL SERVICE must be contacted for
repair.
Connect the power cord only to a proper receptacle with ground connection. Never use
extension power cords nor adapters.
A dirty air filter may affect the oxygen concentration and CO2 elimination. Replace the filter
at least every 90 days or when it is visibly dirty. Never turn over a dirty filter. Always use a
new filter. Replace with a MEDIX filter (cat. DIR-02).
The incubator measurement circuit was designed to be used only with MEDIX sensors
(catalogue DIR-10 skin-reusable or DIR-30 skin-disposable). The use of a different sensor
type will not ensure the normal functioning of the unit and may cause incorrect
measurements that will result in the inappropriate treatment of the patient.
Never attempt to relocate the incubator without having removed all its auxiliary equipment.
Check all oxygen supply systems connected to the incubator have been turned off or
disconnected before beginning any cleaning or maintenance procedure. Fire risk exists in
presence of oxygen enriched atmospheres.
Heater may be hot enough to cause burns. Wait 20 minutes after the POWER has been
turned OFF before removing the engine group.
Take care no fluids enter accidentally the power unit. If case of doubt, do not reconnect the
incubator and call the AUTHORIZED TECHNICAL SERVICE.
Failure to clean impeller and heater elements will result in excessive lint buildup and
reduced airflow. Reduced airflow will affect temperature control and cause high carbon
dioxide (CO2) concentrations.
Do not attempt to clean the air microfilter. Do not reinsert the filter with the dirty side towards
the incubator.
7
CAUTION
The hand port must be opened just by pushing the port latch (PUSH) to prevent breakages.
Never exceed the weight limits recommended for the accessories. See labels on each
accessory.
Temperature sensors are fragile and expensive elements, care is required in their use and
maintenance.
The useful lifetime of a skin-reusable sensor (DIR-10) depends on the care you take when
handling and cleaning.
Do not use alcohol or any oil based solvent for cleaning. Alcohol may cause cracks or
breakages to the acrylic hood or any other plastic parts.
Always start by the motor group hygiene to avoid accidentally wetting it when cleaning the
rest of the equipment.
The main tray must not be subjected to force when being washed. This could cause it to
become distorted leading to faulty seating on the main base of the incubator, affecting its
operation. On reassembly, make sure that the tray is correctly centered and seated, if not,
the incubator may fail to function correctly and alarms may be activated without apparent
reason.
When placing the top verify that it closes completely. In other case there will be oxygen
leakages.
NOTE
ENVIRONMENTAL CONDITIONS RECOMMENDED FOR NORMAL FUNCTIONING
TEMPERATURE: 18-30ºC
BAROMETRIC PRESSURE: 86-106 Kpa (648-795mmHg)
RELATIVE HUMIDITY: 50+/-5%
AIR SPEED: 6-8 m/min
The AIR TEMPERATURE alarm remains silent for 45 minutes after turning on the equipment,
so it can reach the air control temperature selected previously.
In both cases, the sound alarm can be silenced for 15 minutes by pressing the ALARM
RESET key on the command module.
After 15 minutes, if the AIR SENSOR FAILURE alarm condition persists, the sound alarm will
activate again (replace the faulty sensor by one in good condition).
8
In case of a short time power supply failure, the equipment records the functioning mode and
the preset control temperature. When power supply comes back, these settings are reset
automatically. If power supply failure lasts more than 5 minutes or the power switch of the
command module has been turned off, parameters must be set manually.
Staff that could touch connectors identified with the ESD warning symbol should
receive this explanation and training. This includes clinical/biomedical engineering and
health-care staff.
Before operating the incubator, complete its functional check in SECTION 5.7 of this manual.
Hygrometer indicates RELATIVE HUMIDITY inside the hood and not temperature.
The alarm test must be carried out at least once a day during normal functioning of the
equipment.
MEDIX sensors (catalogue DIR-10 skin-reusable and DIR-30 skin-disposable) are high
precision ones and perfectly interchangeable.
Rectal temperature sensors are not appropriate for the use with this equipment. In case of
requiring rectal temperature measurement you must install a rectal temperature monitor with its
respective sensor in the unit.
Skin temperature sensors shall not be used for rectal temperature measurements.
To make sure of a correct skin temperature measurement it is necessary that the metal side of
the sensor makes good contact with the skin (that it does not unstick or separate easily).
Use reflectant sensor covers (cat.#T-80152), specially designed to fix skin temperature sensor.
Due to MEDIX permanent interest in upgrading its products, the manufacturer reserves its
rights to make changes without prior notice.
9
Used Symbols
In the following table we list the symbols that could be found on the equipment or in this manual and the
meaning of each one:
International electrical symbols:

Symbol Description
OFF
ON
SEE USER MANUAL
DANGER – HIGH VOLTAGE
GROUND
APPLICABLE PART TYPE B
HOT SURFACE
FUSE
ESD SENSITIVITY
(ELECTROSTATIC DISCHARGE)
BATTERY
~ ALTERNATING CURRENT
10
Symbols for storage and packing:
Symbol Description
FRAGILE, HANDLE WITH CARE
VERTICAL POSITION
KEEP DRY
TEMPERATURE LIMITATION
4ºC (40ºF) – 43ºC(110ºF)
DO NOT HANG
DO NOT TILT
11
Warning Labels Fixed to the Equipment
12
13
Equipment Identification
S/Nº: XXXX-AA
XXXX: Serial Number
AA: Date of Manufacturing
XXXX: Lot number
14
1. Introduction
The MEDIX PC-305 is a microprocessor-controlled incubator which has been designed to

provide neonates with a secure and complete environment for their care.
The PC-305 has two modes of operation: SKIN and AIR.
Its constructional and functional characteristics define it as an incubator for INTENSIVE
CARE.
1.1 Characteristics
• Controlled interior atmosphere using heated air, circulating in a closed circuit to

provide homogeneous temperature distribution throughout infant’s compartment.
The air is renewed using microfiltered fresh air to avoid build-up of CO2.
• Air temperature electronically controlled within precise limits:
o +/- 0.1ºC for infant’s skin temperature in SKIN mode.
o +/- 0.25ºC for air temperature in AIR mode.
• Automatic defaults:
o AIR mode: 34.0°C
o SKIN mode: 36.0°C
o Initial functioning mode: AIR.
• Alarms: high and low air temperature, high and low skin temperature, sensor
failure, circuit failure, power failure, air circulation failure, overtemperature
(>39ºC)
• Automatic memory of set points if short-term power break occurs.
• Efficient isolation to impede cross-infection between infants in the same treatment
room.
• Controlled provision of microfiltered oxygen over two ranges: up to 40% with
security limiting, and more than 40% when medically indicated.
• Air may be humidified. Optional percent humidity controller and optional
hygrometer available.
• Mattress tray is X-ray transparent and incorporates tilting mechanism. May be slid
out for better access to infant.
• Multiple access through automatic ports, intensive care door, fully opening hood
and other means to facilitate all intensive care procedures.
• All parts of the infant’s compartment may be dismounted without the use of tools,
for ease of cleaning and maintenance.
• All surfaces and materials used are stable and corrosion-free to permit simple and
effective hygiene.
• The heater unit and control electronics are mounted in a single module which is
easily removed for repair or maintenance.
• The incubator is mounted on a rolling cabinet with different options as indicated in
1.3 Cabinet Stands section.
15
• The incubator provides uninterrupted vision of the infant.
• Monitor communication possibility through external interface.
1.2 Basic Equipment
The MEDIX PC-305 is provided with the following elements:
• Complete incubator unit with large dimension acrylic hood, simple wall (optional
double wall), four access ports, two iris side ports, six IV ports and intensive care
door.
• Slide out mattress tray incorporating tilting mechanism, suitable for X-Rays.
• Power unit with microprocessor-controlled electronic servocontrol system.
• Patient sensor for skin temperature measurement.
• Sensor for interior air temperature measurement.
• Oxygen control valve.
• Air microfilter.
• Oxygen microfilter.
• Lower cabinet with wheels at user’s choice.
• Lateral protection.
• Instruction manual.
16
Figure 1: Basic equipment with DIA-36 cabinet stand
1.3 Cabinet Stands
CATALOG DESCRIPTION
DIA-36
Rolling cart with shelf, without doors, four wheels,
two with brakes.
DIA-37
Cabinet stand with central column, with two side
double drawers, four wheels, two with brakes.
17
DIA-39
Cabinet stand with central column with two
drawers, four wheels, two with brakes.
DIA-31 Cabinet stand with electrical pedal for height

adjustment, without drawers, four wheels, two
with brakes.
DIA-32
Cabinet stand with electrical pedal for height
adjustment,,with drawers, four wheels, two with
brakes.
DIA-44 Cabinet stand with two trays, shelf and doors, four
wheels, two with brakes.
18
1.4 Optional Accessories
CATALOG DESCRIPTION
IV Pole
DIA-02
Figure 2: IV pole
DIA-06 Antistatic wheels (4), two with brakes.
Hygrometer for measurement of interior relative humidity (%)
DIA-11
Figure 3: Hygrometer
Humidity control system
DIA-12
Figure 4: Humidity control system
19
CATALOG DESCRIPTION
Acrylic half cylinder.
DIA-15
Radiant heat Shutoff shield.
Double wall system – Protection against radiant heat loses.
Placing the double wall:
1. Raise the hood.
2. Take the mattress tray off.
3. Lower the hood, open the intensive care front door and introduce the
wall coinciding with holes (2) and pins (1) See Figure 5. Double wall
installation. After that, pull up the double wall and lock it as shown in
detail A.
4. Place the double wall on the intensive care door as shown in detail B
DIA-17
Figure 5: Double wall installation

Oxygen hood.
Small (120 mm diameter), Medium (152 mm diameter), Large (200 mm
diameter).
DIA-23
Figure 6: Oxygen hoods

DIR-26 Nest mattress to protect baby inside the incubator.
DIA-28/29 Auxiliary AC outlet box.
20
CATATLOG DESCRIPTION
Continuous Tilting mechanism (+/-10º).
To reach continuous and smooth mattress inclination, two knobs, a red one
corresponding to left command, and a blue one, corresponding to right
command. (Figure 7: Tilting mechanism).
DIA-42
Figure 7: Tilting mechanism
MOUNTING
LEFT side FRONT left BACK left

NOTE: Right side is exactly symmetric.
THIS ACCESSORY IS PLACED INSTEAD OF THE STANDARD TWO
POSITION SYSTEM PROVIDED WITH THE EQUIPMENT.
Oxygen Servocontrol.
DIA-43
Oxygen servocontrol module with support for incubator.
DIA-46 Column with IV pole.
Monitor shelf for DIA-46.
DIA-47 The monitor or accessory shelf is mounted on column with IV pole (cat.DIA-
46) and provides support for additional devices or accessories associated
with the incubator. Maximum load: 25kg.
DIA-48 Short support for accessories (for DIA-46).
DIA-49 Long support for accessories (for DIA-46 ).
DIA-51 Humidity servocontrol.
DIA-53 Holder for oxygen tubes for DIA-37 cabinet stand.
21
1.5 Consumables/Replacement parts
CATALOG DESCRIPTION
DIR-02 Air filter (pack x 4)
DIR-03 Mattress
DIR-04 Access port seal (pack of 4)
DIR-05 Hammock for balance
DIR-06 Iris port sleeves (box x 100)
DIR-10 Skin temperature probe (reusable)
DIR-12 Air temperature probe
DIR-14 Main cable 220/240 V~.
DIR-15 Main cable 110/127 V~
DIR-17 Front IV port (open) (pack x 2 units)
DIR-19 Back IV port (circular) (pack x 2 units)
DIR-20 Port diaphragm (box of 100)
DIR-21 Front door gasket
DIR-22 Base gasket
DIR-23 Mattress tray
DIR-24 Complete port for rechange (unit)

PVC spare parts KIT. Includes: front door gasket, 4
DIR-27 port gaskets, 2 iris gaskets, 2 open IV ports, 2
circular IV ports and top cup
DIR-30 Skin temperature probe (disposable)
T-80152 Reflectant sensor cover
22
1.6 Technical and Functional Specifications
1.6.1 Technical Specifications
Dimensions:
Infant’s compartment (usable space):
Width 83cm
Height 35cm
Depth 38cm
Mattress:
Width 64cm
Depth 35.5cm
Front access door:
Width: 84,5cm
Depth 30,5 cm
External dimensions (basic equipment, with DIA-39 cabinet stand)
Height 139cm
Width 91cm (without all round fender).
106,5cm (with all round fender).
Depth 51.5cm (without all round fender).
61.3cm (with all round fender).
Incubator with adjustable height stand (optional).

Mattress height range: +/-20cm
Gross weight (equipment with DIA-39 cabinet stand): 78kg
Access:
Oval ports, automatic, dismountable and noiseless:4
Iris ports: 2
Lateral IV ports: 2
Back IV ports: 2
Oxygen enrichment capacity: 21% to 40% - 75%+/-5%
Maximum CO2 concentration: << 0,5% (IEC60601-2-19,clause 105 Test)
Humidity: up to 85%+/-5%
Temperature controls:
Air: 20 to 37ºC (0,1ºC) with override temperature key up to 39ºC (*)
Skin: 34 to 37ºC (0,1ºC) with override temperature key up to 38ºC (*)
(*) Control temperature range can be calibrated in factory with other limits on
customer request.
According to IEC60601-2-19 Standard: “Particular requirements for the safety of
baby incubators”, clauses 54.101 and 54.102, control temperature (air and skin) shall
not exceed 39ºC
23
Displays:
• Skin temperature: (control/real temperature)
o Resolution: 0,1ºC.
o Measurement range: 20 to 42ºC.
• Air temperature: (control/real temperature)
o Resolution: 0,1ºC.
o Measurement range: 20 to 42ºC.
• Heater power: range 0-100% in four steps.
Alarms (visual and audible)

• Alarm condition indicator.
• Skin temperatures: +/-1ºC.
• Air temperatures: +1ºC / -3ºC.
• Skin/Air sensor fail.
• Air circulation failure.
• Electronic circuit failure.
• Power failure.
• Air overtemperature (>39ºC) with independent circuit.
• Alarm test: activates all indicators.
• Alarm reset: cancels only acoustic alarm during 15 minutes. Appearing a new alarm
condition activates it again.
• Alarm silencing for 45 minutes after incubator is turned on, allowing selected parameters
stabilize..
Internal battery pack (control module)

Audible alarm for power failure and parameter memory.
Ni-MH 4.8V, 320mA.
! WARNING
It is advisable to change the internal battery pack every 2 years for the safe functioning of
the incubator. Contact your Authorized Technical Service.
Power requirements:
220/240V~ 50/60 Hz
110/127V~ 50/60 Hz. (on request)
Interchangeable Sensors : +/- 0.1 °C.
Automatic initialization:
34°C for air temperature and 36°C for skin temperature.
Memory of control points and operation mode.
24
Baby’s compartment
It has been designed with closed circuit, assuring precise, stable, homogeneous and
preset temperatures.
Completely drivable back acrylic canopy.
Tilting mechanism.
Four IV sets: two in the front and two in the back.
Sliding radiolucent mattress.
Inalterable and easy cleaning acrylic.
Ambient control and patient control

Air temperature sensor, inside the canopy.
Microfiltered air and oxygen (5µm particle filter, 99% efficiency).
Water tank for humidification.
Interchangeable skin sensors.
Construction details and hygiene

Liquid resistant command module.
Cast aluminum base to assure temperature homogeneity.
Lateral connection box to avoid electric shock.
Plasticized base, easy cleaning.
Dismountable heater and fan for cleaning.
User manual.
Packing and storage

Medical equipment – Fragile – Do not pile up.
Ambient conditions: Keep in a dry place.
25
1.6.2 Functioning
Technical specifications and functioning are referred to IEC-60601-2-19 Standard: “Particular

requirements for safety of infant incubators”.
1. Warm-up time: 30 minutes.
2. Temperature variability: +/- 0.2ºC
3. Range of control temperatures:
SKIN MODE (skin control) 34.0°C to 37.0°C with override key up to 38.0ºC.
AIR MODE (air control) 20.0°C to 37.0°C with override key up to 39.0ºC.
4. Temperature overshoot: 0.3ºC.
5. Time to reach equilibrium temperature: 30 minutes (heating rate approximately 10ºC
every 30 minutes).
6. Intervention recuperation temperature: 26°C.
7. Temperature uniformity: +/- 0.2ºC.
8. Temperature control method:
SKIN MODE: Keeps a constant baby skin temperature, according to the preset value
indicated by the clinician (SKIN TEMPERATURE CONTROL).
AIR MODE: Keeps a constant air temperature inside the incubator, according to the
preset value indicated by the clinician (AIR CONTROL TEMPERATURE).
9. Correlation between incubator temperature and indicated temperature at equilibrium:
<0.3°C.
10. Correlation between skin control temperature and indicated skin temperature: <0.1°C.
11. Permanent autocalibration of measurement electronic circuits.
12. Permanent circuit autocheck.
13. Skin temperature alarm activation limits: +/- 1°C referred to skin control temperature.
14. Air temperature alarm activation limits: +1°C, -3°C referred to air control temperature (this
alarm is inhibited for 45 minutes following switch-on to allow incubator to reach equilibrium
temperature).
15. Air velocity over mattress: 0.2 m/sec.
16. Air flow alarm activation delay following air flow interruption: <45 seconds.
17. Resolution of electronic SKIN TEMPERATURE thermometer: 0.1ºC.
18. Resolution of electronic AIR TEMPERATURE thermometer: 0.1ºC.
19. Oxygen concentration: (regulated by oxygen flow rate)
Normal: up to 40%, +/- 5% O2.
High concentration: up to 75%, +/- 5% O2.
20. Humidity: up to 85%, +/- 5% relative humidity.
21. Maximum CO2 concentration: << 0.5% (IEC60601-2-19,clause105 test result).
22. Maximum inner noise level under normal conditions of use: <60dB.
23. Maximum inner noise level during alarm activation: <80dB.
24. Minimum noise level at 3mts from the incubator during alarm activation: >65dB.
25. Maximum weight suggested for trays and shelves: 30Kg.
26. Air filter: filters particles greater than 0.5 microns.
27. Oxygen filter: filters particles greater than 0.5 microns.
! WARNING
Equipment installation, maintenance and repair must be carried out only by qualified
technical staff. Refer to Technical Service Manual for repair or spare parts request.
26
NOTE
Ambient conditions for normal functioning:
Temperature: 18-30ºC
Barometric pressure: 86-106kpa(648-795mmhg)
Relative humidity: 50%+/-5%
Air velocity: 6-8 m/min
1.7 Description of different access to incubator and auxiliary elements
1.7.1 Standard Access

1.7.1.1 General Access
The hood may be completely opened as shown in Figure 8: Completely opened hood. This posit
downwards to free it.
Figure 8: Completely opened hood
1.7.1.2 Access through Intensive Care Door
The front of the hood is fitted with a door to provide free access to the interior as
shown in Figure 9: Completely opened intensive care front door. The door has guides so
that the mattress can be slid out to ease infant’s manipulation.
27
Figure 9: Completely opened intensive care front door – (1) side IV pole (2) PVC stopper
! WARNING
To slide out the mattress, the tilting mechanism must be in horizontal position.
1.7.1.3 Access through Automatic Ports

The hood has four automatic ports which are used for routine procedures
performed on the child.
In order to avoid hand contamination open the hand ports by pressing their latches
with your elbow, as shown in Figure 10: Automatic ports..These ports can be taken
out manually, so that there is no difficulty for them to be cleaned or exchanged.
Figure 10: Automatic ports
CAUTION
The hand ports must be opened just by pushing the port latches (PUSH) as shown
in the figure to prevent breakages.
28
! WARNING
Use hand port sleeves and riris sleeves while the incubator is functioning so as to
protect the infant.
Although the equipment has wheels it is recommended not to move it while a
patient is under treatment.
1.7.1.4 Minor Access Routes
The incubator possesses other means of access for the introduction of

various elements. Feeding tubes, intravenous lines, patient cables etc. gain access
to the Cuff Gasket (1) (Figure 9: Completely opened intensive care front door)
which permits the infant to be introduced or removed without having to disconnect
these elements. The orifice (2) (Figure 9: Completely opened intensive care front
door) corresponds to the use of the weighing scale, without having to remove the
infant from the incubator.
1.7.1.5 Iris port
This access permits the passage of large-diameter tubes and cables which
cannot be introduced using the minor access routes, e.g. a breathing circuit.
Figure 11: Iris access
The port is fitted with a plastic sleeve which closely encircles the tubes thus maintaining
the compartment closed (see Figure 11: Iris access).
These plastic sleeves are easily replaced, a practice which is recommended to maintain
hygiene.
! WARNING
Never leave the baby unattended while the intensive care door, hand ports or iris
ports are open.
29
1.8 Auxiliary Elements
1.8.1 Tilting Mechanism
This is a simple lever mechanism which tilts the mattress +/-8º without requiring
opening of the hood (Figure 12: Tilting mechanism).
Figure 12: Tilting mechanism
The mechanism is operated from the rear of the incubator and may easily be
dismounted for cleaning.
1.8.2 Incorporated X-Ray Tray
Located under mattress tray, allows X-ray procedures without disturbing the
baby.
Figure 13: X-ray tray
1.9 Other Additional Equipment

Besides the specific optional accessories for each equipment, MEDIX has an important
line of equipment that can be required and installed according to user’s particular needs
and equipment’s intended performance.
30
1.9.1 Aspiration system
Venturi system with aspiration hose, vacuum gauge with manometer and suction plastic
vase. Unbreakable, graduated in cubic centimeters and dismountable for easy cleaning.
1.9.2 Weighing scale- MEDIX DIA-01
Mechanical weighing scale with hammock to weight the baby inside the incubator.
Figure 14: DIA-01 Weighing Scale

en centímetros cúbicos, desarmable para favorecer su fácil limpieza.
1.9.3 Electronic weighing scale WS-1
Figure 15: Electronic weighting scale WS-1
1.9.4 Aspiration and reanimation system
On customer’s special request.
1.9.5 Oxygen concentration and cardiac rate monitor
1.9.6 Oxygen concentration monitor (fraction of inspired oxygen)

31
1.9.7 Additional O2 or air tubes
Several models adapted to current regulations.
1.9.8 Energy module TA-04

Inverter with battery and charger. Optional TA-11 for additional battery.
Autonomy of 2(two) hours with pre-warmed incubator or 4(four) hours with optional
TA-11 (SEE ANNEX 2).
1.9.9 MEDIX Phototherapy

Phototherapy equipment. Request catalogue with technical specifications.
1.9.10 Tension Stabilizer

32
2. Unpacking and Assembly
2.1 Installation Instructions
! WARNING
Manufacturer takes responsibility regarding safety, reliability and functioning of the
equipment if:
1 Installation, modification or repair are carried out by technical staff authorized by
MEDIX I.C.S.A., using elements, spare parts or replacement parts exclusively
supplied by MEDIX I.C.S.A.
2 Electrical installation and its corresponding authorization respond to local safety
standards.
3 The equipment is operated according to the operating instructions described in
this manual.
• When unpacking the equipment, check all parts are in good condition. Otherwise, contact
your supplier or sales representative to report this situation at once.
• Carry out a general cleaning of the equipment in accordance with the instructions in
section 7 of this manual.
• Connect the power cable and sensors as indicated in section 4 of this manual.
! WARNING
The power supply cable must be connected to a proper socket with ground connection.
Do not use adapter plugs or extension cables.
• Check the room temperature where the equipment will function is between 20°C and
30°C.
! WARNING
Read Section 5.7 of this manual before to start to use the incubator.
! WARNING
This equipment is not suitable to be used in the presence of anesthetic gases.
! WARNING
Before turning on the equipment, check all the packing protective material has been
removed, including the mattress protecting plastic.
33
! WARNING
MEDICAL EQUIPMENT need special precautions regarding EMC and need to be installed
and put into service according to the EMC information provided in user and technical
service manuals
Figure 16: Scheme showing drawer mounting for different cabinet stand
! WARNING
Air temperature sensor located on acrylic canopy (right lateral) is calibrated in factory for
each incubator separately. Interchanging canopies will require a calibration procedure
as described in Technical Service Manual.
34
3. Functional Description
3.1 Essential Performance
The essential performance of an Intensive Care Infant incubator is to keep an
adequate thermal environment for newborn during long term treatment and assure
isolation of the patient.
3.2 Operating Modes
3.2.1 Skin Mode
In SKIN mode the purpose is to keep the patient’s temperature on a constant value
preset by the clinician. Skin control temperature is properly set using the equipment’s
command module keyboard. A skin temperature sensor is attached to the infant’s
abdomen and the skin temperature value to be controlled is set properly. In this way,
the incubator constantly measures the patient’s skin temperature and supplies the
necessary heat so as to be constant and coincident with the preset control
temperature. Simultaneously, the digital electronic thermometer (SKIN
TEMPERATURE, located on the front panel, displaying red digits) continuously
shows the infant’s temperature so it can be checked at any moment. It is important to
say that when the incubator is in the SKIN mode the infant’s temperature is not
variable. On the other hand the inner incubator’s temperature (AIR TEMPERATURE,
front panel, green digits) may vary with the lapse of time depending on the patient’s
condition. This occurs due to the servocontrol automatic effect that adjusts the air
temperature inside the incubator to keep constant the infant’s skin temperature
according to their needs. At certain moments the infant may need more heat than at
other times, the incubator will modify its temperature according to that need. It is also
very usual that the infant’s skin temperature does not coincide with the incubator’s
temperature due to the reason described above.
EXAMPLE: An infant weighing 1500g who a few hours after birth has a preset skin
temperature of 36.0°C, may need the incubator to be at 35.5°C.
On the other hand fifteen days old infant weighing 2200g, for a skin temperature of
36.0 °C, may need the incubator to be at 33.0 °C.
This regulation of the incubator’s temperature is done automatically.
3.2.2 Air Mode
In AIR mode the purpose is to keep the incubator temperature (i.e. the air
temperature) a constant value. The incubator temperature is indicated by the digital
electronic thermometer of AIR TEMPERATURE. The air control temperature is set
using the equipment command module keyboard. In this functioning mode the SKIN
TEMPERATURE display remains off.
35
! WARNING
In SKIN and AIR modes the control temperature must be determined by the CLINICIAN
according to the infant’s age, weight and general conditions.
3.2.2.1 Air Mode with Electronic Thermometer
In AIR mode it is also possible to display skin temperature and to have the added
benefit of the skin temperature alarm system by simply plugging in the skin
temperature sensor and attaching it to the infant.
3.3 Security Systems
3.3.1 Air Temperature Alarm
This alarm is activated if the incubator’s air temperature is 1ºC higher, or 3ºC lower than
the preset air control temperature. This alarm is only operative in AIR mode. If the
incubator’s air temperature is 1ºC higher than the control temperature:
1. The acoustic alarm sounds intermittently.

2. The AIR TEMP. alarm flashes (red indicator on front panel).
3. Power to the heater is interrupted (the HEATER POWER indicator is off, yellow
indicator on the front panel).
4. The AIR TEMPERATURE display flashes the air temperature reading.
If the incubator air temperature is 3ºC lower than the control temperature:

2. The AIR TEMP. alarm flashes (red indicator on front panel).
3. Full power is supplied to the heater (the HEATER POWER indicator is fully
illuminated).
4. The AIR TEMPERATURE display flashes the air temperature reading.
In both cases the audible alarm can be silenced for 15 minutes by pressing the ALARM
RESET button on the front panel. If case the alarm condition has not been corrected by
the end of the 15 min period, the audible alarm will sound again.
NOTE
The AIR TEMPERATURE alarm remains silent for 45 minutes after turning on the equipment, s it
can reach the air control temperature selected previously.
36
3.3.2 Skin Temperature Alarm
This alarm is activated if the infant’s skin temperature differs by more than 1ºC from the
preset value. The alarm is operational in SKIN mode and in AIR mode when an electronic
thermometer is also in use. In SKIN mode, when the infant’s skin temperature is 1ºC
higher than the preset skin control temperature, the following takes place:

2. The SKIN TEMP. alarm flashes (red indicator on front panel).
3. Power to the heater is interrupted (heater power indicator off).
4. The SKIN TEMPERATURE display flashes the skin temperature reading.
On the other hand, when the infant skin temperature is more than 1 deg C below the
preset skin control temperature the following takes place:

3. Full power is supplied to the heater (the HEATER POWER indicator is fully
illuminated).
When in AIR mode and using an electronic thermometer, if the infant’s skin temperature
differs by more than 1ºC from the preset skin control temperature, the following takes
place:

3. The control system supplies power to the heater in order to maintain the
incubator’s air temperature constant at the preset air control temperature (the
HEATER POWER indicator will have some segments illuminated).
NOTE
The sound alarm can be silenced for 15 minutes by pressing the ALARM RESET key on the front
panel. After these 15 minutes and if the alarm condition persists, the sound alarm will activate
again.
37
3.3.3 Overheating Alarm (Temperature greater than 39°°C)
This alarm is activated when the air temperature within the incubator exceeds 39°C.
NOTE
In AIR MODE if override key (>37ºC) is deactivated, the OVERHEATING alarm will activate with
an air temperature of >37ºC.
The electronic circuit of this alarm is independent from the microprocessor circuit, to
upgrade system reliability. Its main purpose is to protect the infant against a servocontrol
failure and any other alarm controlled by the microprocessor.
This alarm works in EVERY functioning mode of the incubator. When the air overheating
alarm activates, the following takes place:

2. The T >39°C indicator flashes (red indicator on front panel).
3. A relay circuit interrupts power to the heater.
4. As the alarm electronic circuit is independent from the microprocessor, the power
value shown in the HEATER POWER indicator must be ignored.
The sound alarm can be silenced for 15 minutes by pressing the ALARM RESET key
on the command module. After these 15 minutes and if the alarm condition persists,
the sound alarm will activate again. If an incubator in this alarm condition is not
attended, after some time it will cool under 39ºC since the heater is deactivated. In a
determined temperature value, the alarm automatically deactivates and again supplies
powewr to the heater. If the failure that activated the alarm persists, the incubator will
exceed the 39ºC again and the alarm will activate.
! WARNING
If the overtemperature problem still persists, the equipment cannot operate normally until
the failure is solved. It is recommended to call the Authorized Technical Service.
3.3.4 Air Flow Failure Alarm
This alarm activates thief a forced air flow system failure occurs inside the incubator. This
alarm works in every functioning mode of the equipment. When the air flow failure alarm
activates, the following takes place:
1. The audible alarm sounds intermittently.

2. The CIRCUIT FAILURE INDICATOR flashes (red indicator on front panel).
3. A relay circuit interrupts power to the heater (HEATER POWER indicator off).
38
The audible alarm CANNOT be silenced by pressing the ALARM RESET key on the front
panel. The incubator will not be operable until the fault has been corrected. The user must
call for Authorized Technical Service.
! WARNING
The equipment cannot operate normally until the air flow failure is solved. It is
recommended to call the Authorized Technical Service.
3.3.5. Sensor Failure Alarm
This alarm is activated by a failure in either the skin or air sensor. It is operative in every
functioning mode. When the alarm activates the following takes place:

2. The SENSOR indicator flashes (red indicator on front panel).
3. A relay circuit interrupts power to the heater (HEATER POWER indicator off).
4. “--.-“ is shown in the corresponding display.
NOTE
The sound alarm may be silenced for 15 minutes by pressing the ALARM RESET button on the
front panel. After 15 minutes, if the sensor failure alarm persists, the sound alarm will activate
again (replace the damaged sensor by one in good condition).
3.3.6 Circuit Failure Alarm
This alarm activates with an alteration in the microprocessor functioning logical sequence.
This alarm works in every functioning mode of the equipment. When the alarm activates
the following takes place:

2. The CIRCUIT FAILURE indicator flashes (red indicator on front panel).
3. A relay circuit interrupts power to the heater. The audible alarm CANNOT be
silenced by pressing the ALARM RESET button on the front panel.
Under these conditions the incubator will not function properly. It is advisable to turn the
equipment off and then turn it on again to reset the microprocessor.
! WARNING
If the circuit failure alarm is activated again, it is recommended to turn the incubator off
and call the AUTHORIZED TECHNICAL SERVICE.
39
3.3.7 Main Power Fault Alarm
This alarm activates either because of an interruption in the mains, fuses or power supply
input circuit failure occurs, or there is an accidental unplugging. When the alarm activates,
the following takes place:

2. The MAINS FAILURE indicator flashes (red indicator on front panel).
The audible alarm CANNOT be silenced by pressing the ALARM RESET button on the
front panel. When this alarm activates, it is advisable to proceed as follows:
1. Check the equipment plug is well connected to the power supply socket.
2. Check the main power supply voltage in the socket where the equipment is
connected.
3. If the above mentioned instructions do not solve the failure, turn the incubator off
and contact the Authorized Technical Service.
NOTE
In case of a short time power supply interruption, the incubator records the functioning mode and
preset control temperature. When power supply comes back, these settings are reset
automatically. If power supply interruption lasts more than 5 minutes or the power switch of the
equipment has been turned off, parameters must be set manually.
3.3.8 Fresh Air Intake Security System
When the incubator functions with high oxygen concentrations (red flag in high position),
the fresh air input is closed to allow the entry of pure oxygen.
In case of sudden interruption of the oxygen supply, either because the oxygen cylinder is
empty or the hospital supply system fails, the incubator has a safety system that allows
automatically the fresh air input, to avoid CO2 concentration increase inside the infant’s
compartment.
3.4 Security – Very Important Warnings
! WARNING
The use of oxygen increases the equipment risk of fire.
! WARNING
Small quantities of flammable agents such as alcohol inside the incubator, increases risk
of fire in presence of oxygen.
40
! WARNING
Avoid direct sunlight, radiant power sources and cold drafts since these factors may alter
the incubator’s normal functioning and even activate alarms.
! WARNING
Regularly check the patient’s temperature and the functioning of the equipment’s
indicators.
! WARNING
The power supply cable must be connected to a proper socket with ground connection. Do
not use adapter plugs or extension cables.
! WARNING
Make sure that the auxiliary equipment connected to the patient is electrically safe.
3.5 Comments about Electromagnetic Compatibility
The MEDIX PC-305 Infant Incubator has been tested and meets the requirements of IEC
60601-1-2:1993, “Electromagnetic Compatibility” Standard.
3.5.1 Emissions
According to tests made to the equipment, it does not emit radiofrequency radiations
(RF) of low frequency nor magnetic fields that may cause interference risk to the safety
of other equipment (according to CISPR11).
3.5.2 Immunity
The equipment complies with requirements specified by IEC-60601-2-19 standard
(clause 36.202), facing radiofrequency electromagnetic fields:
o The unit keeps functioning as expected according to chapter 3 of this
manual, up to a 3 V/m level, for the frequencies interval of 26MHz to
1GHz.
o The unit keeps functioning as expected according to chapter 3 of this
manual, or aborts without causing a safety risk for in a lower or equal level
to 10V/m, for the frequencies interval of 26MHz to 1GHz.
! WARNING
Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL
EQUIPMENT.
41
3.5.3 Electrostatic Discharge
The equipment meets the requirements of CEI 801-2:1991 standard: Electromagnetic
Compatibility for measurement and industrial process control equipment, Part 2:
Requirements referred to electrostatic discharges.
! WARNING
Pins of connectors identified with ESD warning symbol should not be touched
and connections should not be made to these connectors unless ESD precautionary
procedures * are used.
3.5.4 Bibliography
“Guidance on Electromagnetic Compatibility of Medical Devices for Clinical/Biomedical
Engineers-Part 1: Radiated Radio-Frequency Electromagnetic Energy”, AAMI TIR
No.18-1997
*
Precautionary procedures include:
- methods to prevent build-up of electrostatic discharge (e.g. air conditioning, humidification, conductive floor coverings,
non synthetic clothing)
- discharging one’s body to the frame of the equipment or system or to earth or large metal object.
- bonding oneself by means of a wrist strap to the equipment or system or to earth.
NOTE
Staff that could touch connectors identified with the ESD warning symbol should receive this explanation
and training. This includes clinical/biomedical engineering and health-care staff.
ESD training should include an introduction to the physics of electrostatic charge, the voltage levels that can occur in normal
practice and the damage that can be done to electronic components if they are touched by an operator who is electrostatically
charged. Further, an explanation should be given of methods to prevent build-up of electrostatic charge, and how and why to
discharge one’s body to earth or to the frame of the equipment or system, or bond oneself by means of a wrist strap to the
equipment or system or to earth prior to making a connection.
42
4. Command Module Description
4.1 Indicators and Front Panel Controls
Figure 17: Group motor front panel
The description refers to Figure 17: Group motor front panel.
1 - AIR TEMP. SET key

By pressing it causes the preset air control temperature (SKIN mode) to be displayed
on the AIR TEMPERATURE display (21). Pressing this button also enables the
INCREASE (3) and DECREASE (4) keys which are used to increase or decrease
the air control temperature respectively.
2 - SKIN TEMP. SET key

By pressing it causes the preset skin control temperature (SKIN mode) to be
displayed on the SKIN TEMPERATURE display (19). Pressing this button also
enables the INCREASE (3) and DECREASE (4) keys which are used to
increase or decrease the skin control temperature respectively.
3 - INCREASE key
By pressing it simultaneously with the AIR TEMP. SET key (1) allows the air control
temperature to be increased in AIR mode. By pressing it simultaneously with the
SKIN TEMP. SET key (2) allows the skin control temperature to be increased in SKIN
mode.
43
4 - DECREASE key
By pressing it simultaneously with the AIR TEMP. SET key (1) allows the air control
temperature to be decreased in AIR mode. By pressing it simultaneously with the
SKIN TEMP. SET key (2) allows the skin control temperature to be decreased in
SKIN mode.
5 - AIR MODE SELECT key

By pressing it for two or more seconds causes AIR mode to be selected (control of air
temperature).
6 - SKIN MODE SELECT key

By pressing it for two or more seconds causes SKIN mode to be selected (control of
skin temperature).
7 - ALARM TEST key

By holding down this key:
• The HEATER display (20) will lit all its segments.

• The SKIN MODE indicator (18) or the AIR MODE indicator (22) will lit depending
on the control mode currently selected.
• The POWER (11), AIR TEMP. (9), SENSOR FAILURE (14), AIR FAILURE (16)
and SKIN TEMP. (17) indicators will lit.
• The T >39°°C (10), CIRCUIT FAILURE (12), POWER FAILURE (13) and ALARM
(15) indicators will flash.
• The audible alarm will sound intermittently.
8 - ALARM RESET key

By pressing this key the audible alarm corresponding to air temperature, air
overheating, sensor failure or skin temperature is silenced for 15 minutes. After these
15 minutes, if the cause of the alarm condition persists or a new cause is present then
the alarm will activate again.
9 - AIR TEMP. alarm indicator (red indicator)

Flashes when an air temperature alarm condition is present: incubator’s air
temperature is 1ºC higher or 3ºC lower than the control air temperature in AIR mode.
10 - TEMPERATURE >39°°C indicator

Red indicator which flashes when the air overheating alarm activates (incubator’s air
temperature exceeds 39°C).
11 - POWER indicator
Green indicator which is active when the incubator is connected to main power and
the principal on/off switch is in the on position.
44
12 - CIRCUIT FAILURE indicator
Red indicator which flashes when the microprocessor fails to follow a logical
sequence of operations.
13 - POWER FAILURE indicator

Red indicator which flashes on interruption of the AC main power, accidental
disconnection, blown main fuses or failure in the main power input circuitry.
14 - SENSOR FAILURE indicator

Red indicator which flashes when there is a failure (open or short circuit) in either the
skin or air temperature sensor.
15 - ALARM indicator
Red indicator which flashes when any alarm condition is present. It is turned off by
pressing the ALARM RESET (8) button which silences the audible alarm. See
description of the ALARM RESET button (8).
16 - AIR FAILURE alarm indicator

Red indicator which flashes when there is a failure in the forced air circulation system.
17 - SKIN TEMP. alarm indicator

Red indicator which flashes if the infant‘s skin temperature differs in 1ºC from the
preset skin control temperature.
18 - SKIN MODE indicator

Green indicator which is on continuously when the incubator is operating in SKIN
mode (skin temperature control mode).
19 - SKIN TEMPERATURE digital display

Red digital indicator which permanently displays the infant’s skin temperature when
the incubator operates in SKIN mode or in AIR mode when a skin sensor is in use. It
is also used to display the skin control temperature when the SKIN TEMP. (2) button
is pressed.
20 - HEATER POWER display

Yellow segmented display which continuously indicates the power level applied to the
heater. The power is indicated in four discrete steps of 1/4, 1/2, 3/4 and 1. If the
indicator is not lit it means that power is not being supplied to the heater. If the display
is fully illuminated it means that full power is being supplied to the heater.
21 - AIR TEMPERATURE digital display

Green digital indicator which permanently displays the air temperature in the
incubator in SKIN mode and in AIR mode. It is also used to display the air control
temperature when the AIR TEMP. (1) button is pressed.
45
22 - AIR indicator
Green indicator which is continuously illuminated when the incubator is in AIR mode
(air temperature control).
27 - RANGE EXTENSION KEY

By pressing this key, the extension of range of control temperatures up to 39ºC is
allowed.
28 - EXTENDED RANGE Indicator

Its lit when the RANGE EXTENSION is activated.
4.2 Side Panel Controls and Connectors

The description is keyed to Figure 18: Lateral panel.
23 - Main on/off switch.
24 - Power cable inlet.
25 - Connectors for air temperature sensors and air overheating alarm.
26 - Connector for skin temperature sensor.
Figure 18: Lateral panel
46
5. Operating Instructions
NOTE
Before operating the incubator, complete its functional check in SECTION 5.7 of this manual.
The incubator should be opened for a few minutes to air, then closed and prewarm before
use. Turn the POWER switch ON. The incubator will start in AIR MODE (factory default).
Set the desired temperature according to the clinician or hospital protocols. The incubator
must be prewarmed without water in the HUMIDITY RESERVOIR and without the skin
temperature sensor connected.
! WARNING
There are two reasons why the permanent attention of qualified medical staff is
required when there is a patient in the incubator:
1) Some malfunctions situations require immediate corrective actions.
2) One alarm or a combination of alarms does not ensure a total alert of some or
all the malfunctioning situations of the incubator system.
!
WARNING
The incubator must be operated only by properly trained staff and under the
command of qualified medical staff familiar with the risks and benefits on use of
incubators is known.
!WARNING
For infants´ safety do not leave them unattended while the intensive care door or
the hand ports of the incubator are open.
Do not raise both sides of the mattress with the tilting mechanism.
Do not raise the hood with an infant in the incubator. If tubing or leads are
connected to the infant it could result in harm. All necessary access to the infant
can be achieved by means of the front door and hand ports.
! WARNING
If the front door is left open the temperature over the mattress may fall under the
set level. If the front door is left open the air temperature display will be
inaccurate.
47
!WARNING
Do not place the incubator under direct sunlight or close to any other radiant heat
source. External heat sources may cause high inner temperatures that may
overheat the infant. Phototherapy units placed too close to the incubator may
affect the hood walls’ temperature, the inner temperature and the infant’s skin
temperature.
! WARNING
This equipment is not designed to function in explosive atmospheres or in the
presence of flammable anaesthetics. Its use in such environments may represent
an explosion danger.
! WARNING
Do not place supports, toys, sheets, nappies, pillows, etc. This may affect the
correlation between the incubator temperature and the patient’s skin
temperature. The use of accessories inside the incubator may alter the air flow
parameters or affect the temperature uniformity, the correlation of the variability
of the incubator temperature reading and the temperature in the center of the
mattress and the infant’s skin temperature.
!
WARNING
Do not place or hang any material or object on the air sensor located at the bottom
right side of the incubator compartment base. This may cause incorrect readings
and badly affect the unit functioning.
! WARNING
When X-Rays are taken through the hood, take into account that the hole for the
hammock weighing scale in the upper part of the acrylic hood can be shown in
the X-Ray as a radiolucent shadow.
! WARNING
Set the brakes on the wheels when the incubator is functioning.
CAUTION
Never exceed the recommended accessories weight limits. See labels on each
accessory.
48
5.1 Air Mode
1 Connect the power supply cable to the connector (24) on the side panel and to a
socket of 220/240 V~ - 50/6OHz (110/127 V~ 60/50Hz) (as applicable).
!
WARNING
Check the mains power supply socket has its respective ground connection.
2 Turn the incubator on with the main power switch located on the side panel (23).
Check that the POWER light on the front panel (11), lights up.
3 Check that the air temperature sensor is connected to the connector (25) on the
side panel. Observe the air temperature indicated on the AIR TEMPERATURE
display (21- green digits).
4 When switching on the incubator, it automatically selects the AIR mode with a
34.0°C air control temperature. Check that the AIR MODE indicator is lit (22).
5 Set the air control temperature prescribed by the clinician. This is set by pressing
the AIR TEMP. SET key (1) and using the INCREASE (3) or DECREASE
(4) keys to vary the temperature. Such value is shown on the AIR
TEMPERATURE display (21). At any time the air control temperature may be
seen on the AIR TEMPERATURE (21) display by pressing the AIR TEMP. SET
key (1).
! WARNING
The functioning mode and the control temperature must be determined by the
clinician for each infant according to their weight, age and general conditions.
The use of the equipment without the supervision of qualified staff may cause
serious damage to the patient’s health.
6 Watch that the HEATER display (20) has all of its segments lit.
The heater is receiving full power as the incubator temperature rises. As

temperature approaches the air control temperature, the power supplied to the
heater is gradually reduced. This will be reflected by the HEATER indicator (20).
The incubator’s warm up time will depend on the environmental temperature and
on the selected air control temperature.
When a stable temperature is reached, the temperature indicated on the AIR

TEMPERATURE display (21) must coincide with the air control temperature with
a difference not higher than 0.3ºC.
49
5.2 Skin Mode
1 Repeat steps 1, 2 and 3 on AIR MODE.
2 Select SKIN mode by pressing the SKIN MODE SELECT key (6) for more than 2
seconds. Watch the green SKIN MODE indicator (18) light up.
3 When turning the equipment on with the power supply switch, the incubator
automatically sets a skin control temperature of 36.0ºC. Select the skin control
temperature prescribed by the clinician, pressing simultaneously SKIN TEMP.
SET key (2) and INCREASE (3) or DECREASE (4) key. Such value will be
shown on the SKIN TEMPERATURE display. At any time the SKIN TEMP. SET
key (2) can be used to display the skin control temperature on the SKIN
TEMPERATURE display (19).
4 Attach the skin temperature or patient sensor, sticking its end to the infant’s
abdomen, below the navel. Pass the cable through one of the CUFF GASKET
ports on the side panel of the acrylic hood and plug in to the corresponding
connector (26).
5 Watch the skin temperature value shown by the SKIN TEMPERATURE display
(19).
Under these conditions the incubator will operate automatically, delivering more or less
heat according to the skin control selected temperature. If the measured skin temperature
is lower than the selected skin control temperature, the incubator will deliver heat
continuously and all segments on the HEATER indicator will be lit.
If the measured skin temperature is greater than the control temperature, no power will be
supplied to the heater and no segment on the HEATER indicator will be lit. If the
measured skin temperature and the control temperature are almost equal to each other
the incubator will supply just enough heat to keep this temperature constant and only
some of these segments will be lit.
Remember that the incubator’s air temperature does not necessarily need to coincide with
the skin temperature, as explained in SKIN MODE (p. 37).
5.3 Important Recommendations for the Use of Temperature Sensors

Check the sensor is free of residues of adhesive and that the cable is in good condition. If
cleaning is required use cotton wool and take care not to force the connection of the cable
with the sensor end. Do not use oil derivatives. Clean the infant's skin to assure a good
contact. Use hypoallergenic adhesive tape or special adhesive pads to fix sensor,
preventing skin damage. In case of using a disc type sensor (catalog No DIR-10) the
metallic face must be in contact with the skin. Check carefully that the sensor makes good
contact with the skin, to make sure of a proper temperature measurement.
50
! WARNING
The rectal temperature sensors (catalogue number DIA-14) must be used only to indicate
and not to control the infant temperature.
The only sensors to be used must be the ones supplied by MEDIX since the measurement
circuit is designed specifically for these sensors and within strict margins of tolerance.
The use of a different sensor will cause the incorrect functioning of the incubator or what
is even more dangerous, it may indicate wrong temperature readings that will make the
incubator work with inadequate temperature values.
! WARNING
MEDIX DIR-10 sensors (skin- reusable) and MEDIX DIR-30 sensors (skin–disposable) are
both of high precision and perfectly interchangeable. Temperature sensors are fragile
and expensive elements. Care is required in their use and maintenance.
5.4 Air Mode with Electronic Thermometer
In certain cases it may be useful to use the MEDIX PC-305 incubator in AIR mode and at
the same time use the digital display to indicate infant’s skin temperature with the
additional advantage of having an operational skin temperature alarm system (activated
when skin temperature differs by more than 1ºC from the control temperature). This is
achieved as follows:
1 Repeat steps 1, 2, 3, 4, 5 and 6 of AIR mode.

2 Repeat steps 3 and 4 of SKIN mode.
3 The incubator will now be working in AIR mode and the SKIN TEMPERATURE
display will be indicating the infant’s temperature.
It must be remembered that the SKIN TEMPERATURE display only indicates the infant’s
temperature and has NO EFFECT on the incubator’s air temperature. Such temperature
will be preset for the air control.
5.5 Instructions for Supplying Oxygen
The interior atmosphere of the incubator may be enriched with oxygen.

The oxygen can be supplied from a tank of compressed oxygen fitted with a pressure
reducing valve and flowmeter or from the hospital oxygen supply via the corresponding
flowmeter. Given that an oxygen concentration of more than 40% can be harmful to the
infant, the use of oxygen in the incubator should be recommended and supervised only by
qualified medical staff.
51
! WARNING
Whenever oxygen is administrated to the incubator, the resulting concentration must be
measured with a duly calibrated oxygen concentration analyzer.
5.5.1 Oxygen Connection
Plug the oxygen hose to the oxygen input nipple. This nipple has a washable oxygen filter.
For its cleaning just unscrew the nipple, remove the filte and wash it with soapy water.
5.5.2 Oxygen Supply
Open the oxygen supply according to the concentration desired to be obtained inside the
infant’s compartment.
The resulting oxygen concentration approximate values appear on a label fixed to the
incubator, as follows:
Figure 19: Table with approximated oxygen concentration result
Figure 20: Oxygen valve
52
! WARNING
The values given in the tables are reference parameters.
In all cases the oxygen concentration level must be checked with a duly calibrated oxygen
analyzer. The oxygen partial pressure must be periodically monitored as prescribed by
the specialized clinician or hospital protocol.
5.5.3 Very Important Warnings
! WARNING
The presence of oxygen in the air considerably increases the flammability of all materials.
Prevent the production of flames or sparks by other electrical equipment in poor
maintenance conditions.
In case of accident, immediately stop the oxygen supply and disconnect the incubator
from the main power supply.
WARNING
Opening intensive care door or hand ports cause sudden oxygen concentration falls
inside the incubator. This situation may affect the infant. Periodically check proper
functioning of the hand ports latches and gaskets.
! WARNING
Small quantities of flammable agents, such as ether or alcohol left in the incubator may
cause fire in the presence of oxygen.
! WARNING
Do not place a humidifier in line with the Oxygen supply. Water droplets could obstruct
the air microfilter (0.5 microns) and thereby alter correct functioning. If it is necessary
to increase the humidity, see “5.6 Instructions for Use of Humidifiers ” in this chapter.
! WARNING
The use of oxygen in the incubator must be supervised only by qualified medical staff.
Inappropriate additional oxygen administration has been associated with blindness, brain
damage and death as well as other serious side effects which vary in each patient.
Whenever oxygen is administered to the incubator, the resulting concentration must be
measured with a duly calibrated O2 concentration analyzer.
53
! WARNING
The use of oxygen hoods and the forced injection of oxygen may increase noise level
inside the incubator.
5.6 Instructions for Use of Humidifiers
The MEDIX PC-305 is fitted with a special water tank with a capacity of about 750 ml.
Heated air from the heater unit passes over the water surface causing the water to
evaporate and hence raise the relative humidity in the infant’s compartment.
If raised humidity is necessary, follow these instructions:
1 Pour water into the incubator via the inlet pipe shown in figure 21: Water charging
making sure not to exceed the level indicated on the pipe. Cap the pipe.
Figure 21: Water charging
! WARNING
In order to avoid liquid spillage during transport, it is necessary to respect the
indicated “max” and “min” water levels.
Figure 22: MAX and MIN levels
54
! WARNING
In order to avoid the spread of bacteria use only distilled and sterilized water.
Change the water at least every 12 hours. Do not leave water in the reservoir
when the incubator is not in use.
2 In order to drain the water rotate the filling pipe to the left until it is pointing
downwards as shown in figure 23: Water draining.
Figure 23 Water draining
3. Relative Humidity Control Unit

This is an optional control (Cat.# DIA-12)
Once the water tank has been filled, the degree of humidity is set using the HUMIDITY
control knob. See figure 24: Humidity control knob adjustment.
The knob should be pulled outwards to unlock it and then turned to the desired setting.
Figure 24: Humidity control knob adjustment
The approximate humidity percentages corresponding to the control knob

positions are as follows:
55
POSITION OF CONTROL % RELATIVE HUMIDITY
(APPROXIMATED)
1 MINIMUM
2 80%
3 85%
4 90%
! WARNING
If the environmental temperature in the treatment room is low, the water vapor in the
incubator may condense on the hood walls thus impeding full vision of the interior. This
condensation will not affect the correct functioning of the incubator.
CAUTION
Do not leave water in the water tank when the incubator is out of use.
5.6.2 Hygrometer for Measurement of Relative Humidity
This hygrometer is optional (Cat. # DIA-11). The incubator can be fitted on request with an
hygrometer to indicate relative humidity in the infant’s compartment. The hygrometer and
its mounting can be easily removed for cleaning.
NOTE
Hygrometer indicates RELATIVE HUMIDITY inside the hood and not temperature.
5.7 Functional Checking Procedure
This operational and functional checking procedure must be carried out before using the
incubator and after any disassembly for cleaning or repair.
! WARNING
Read the Functional Checking Procedure in Section 5,7 of this manual before operating
the incubator. If a problem is detected during any stage of the Functional Checking
Procedure, the incubator must not be used and contact Authorized Technical Service
for repair.
1. Before connecting the incubator to electrical power (wall outlet), turn the POWER
switch ON. The POWER FAILURE ALARM should activate. Turn the POWER
switch OFF and the ALARM will go off. If the alarm fails to activate, call the
Authorized Technical Service. The alarm backup battery may require
replacement.
56
2. Connect the main power cable to a wall outlet.
! WARNING
The power supply cable must be connected to a proper socket with ground connection.
Do not use extension cables or adapter plugs.
3. Check the air intake filter on the back of the unit. If visibly dirty, it should be
replaced.
! WARNING
A dirty air filter may affect oxygen concentration and CO2 elimination. Replace filter at
least every 90 days or when visible dirty. Never turn over a dirty filter. Always use a
new filter. Replace with a MEDIX filter (cat.DIR-02).
4. Turn the incubator POWER switch ON. Press the ALARM TEST button. All
ALARM lights should light up and the audible alarm should sound. If any failure
is detected, the unit should be referred to qualified personnel for servicing.
NOTE
The ALARM TEST must be carried out at least once a day during normal functioning of the
equipment.
5. Ensure the incubator is in AIR MODE by pressing and holding the AIR MODE
SELECT button for 2 seconds. Close the hood access openings. Set the AIR
TEMPERATURE in 34ºC (default setting) by pressing and holding the AIR
TEMP. SET and the INCREASE/DECREASE buttons. Let the unit warm up for
45 minutes. When the AIR TEMPERATURE is stabilized, the HEATER power
indicator should be within ¼ to ¾ of power. The AIR TEMPERATURE should
remain within 0.5ºC of the set point.
6. Test the AIR TEMPERATURE ALARM changing the setting temperature to

32.9ºC (1.1ºC below 34ºC) and then set it at 37.1ºC (3.1ºC over 34ºC). The
acoustic and visual alarm must activate on every test and it must be cancelled
when the air temperature setting returns to 34ºC.
7. Check SKIN MODE operation by pressing and keeping pressed for two seconds
the SKIN MODE key. Close all hood openings. Connect skin temperature sensor
and leave its end on the center of the mattress. Set the skin temperature in 36ºC
(set by default) by pressing and keeping pressed simultaneously SKIN MODE
key and INCREASE or DECREASE key. Let the compartment’s air temperature
increase until skin temperature display remains within 0.5ºC from setting point.
57
8. Test the skin temperature alarm changing the setting temperature to 34.9ºC
(1.1ºC below 36ºC) and to 37.1ºC (1.1ºC over 36ºC). The acoustic and visual
alarm must activate on every test and must be cancelled automatically when
SKIN TEMPERATURE SETTING returns to 36ºC.
9. With the incubator in SKIN MODE, test SENSOR FAILURE ALARM

disconnecting the skin temperature sensor from its connector. The acoustic and
visual alarm must activate and the HEATER POWER indicator must be 0%.
The incubator must return to normal functioning when the sensor is reconnected
10. Check operation of the tilting mechanism by raising and lowering each side
independently.
11. Check that the mattress deck assembly is seated properly and is secured to the
incubator’s base. Check that the rubber gasket is in place (the hood should make
contact with the gasket on all sides).
12. Check access ports functioning by pushing the port door release. Each door
should swing open. Close the door and check that the door latch is working
properly.
13. Check iris ports rotating the external ring and watching the opening and closing
of the iris sleeves (cat. DIR-06).
Functional Checking Procedure of the unit is now complete.

If the unit is to be stored, turn the POWER switch OFF and close all hood openings.
If any problem is detected during the Functional Checking Procedure, contact qualified
staff for technical service.
58
6. Troubleshooting
In this chapter a series of recommendations are offered to help solve common troubles.
! WARNING
The manufacturer assumes responsibility concerning safety, reliability and functioning of
the equipment if:
• Installation, modification or repairing tasks are carried out by MEDIX I.C.S.A.

authorized technical service staff, using elements, spare parts or replacement parts
exclusively supplied by MEDIX I.C.S.A.
• Electric installation and its corresponding authorization respond to local safety
standards.
• The equipment is operated according to the operating instructions described in this
manual.
6.1 Skin Temperature Probe
6.1.1 Probe Type
! WARNING
The incubator measurement circuit was designed to be used only with MEDIX sensors
(catalogue DIR-10 skin-reusable or DIR-30 skin-disposable). The use of a different sensor
type will not ensure the normal functioning of the unit and may cause incorrect
measurements that will result in the inappropriate treatment of the patient.
NOTE
MEDIX sensors (cat. DIR-10 reusable, cat.DIR-30 disposable) are high precision ones and
perfectly interchangeable.
NOTE
Rectal temperature sensors are not appropriate for use in this equipment. In case of requiring
rectal temperature measurement you must install a rectal temperature monitor with its respective
sensor.
Skin temperature sensors must not be used for rectal temperature measurement.
CAUTION
Temperature sensors are fragile and expensive elements. Care is required in their use
and maintenance.
59
6.1.2 Sensor Problems
In cases of trouble with the skin temperature sensor, it is recommended:
• Check the metal side of the sensor is in contact with the patient’s skin.
• Check the sensor is free of adhesive residues and that the cable is in good condition.
If cleaning is necessary, use a cotton pad moistened with alcohol, avoid forcing the
union between the cable and the sensor.
• Clean the infant’s skin to be sure of good contact.
• Use hypoallergenic adhesive band or reflective sensor covers (MEDIX T-80152)
(special ones for sensor fixing) to avoid skin damage.
NOTE
To make sure of a correct skin temperature measurement it is necessary that the metal side of the
sensor makes good contact with the skin (that it does not unstick or separate easily).
NOTE
Use adhesive tape or hypoallergenic reflective adhesive pads (especially designed to fix
sensors, Cat.#T-80152) to prevent skin damage.
6.2 Alarms
In case that any alarm activates the first thing to be done is to check the patient
condition. After having the patient under control, depending on the type of alarm, it is
suggested:
FAILURE POSSIBLE CAUSE SOLUTION

Skin Temperature Skin temperature differs in - Check the sensor is correctly
ALARM +/-1°C from the preset located and fixed to the infant’s
Control Temperature skin.
Equipment working in - Check the patient’s status (i.e.
SKIN MODE The skin temperature sensor fever).
is not correctly attached to - Check for environmental
the infant’s skin (SKIN mode factors in the nursery room: do
only) not place the Infant Incubator
in drafts, close to open
The equipment is in AIR windows, air conditioners,
MODE and the skin radiators or other heat sources.
temperature set is out of - Check room temperature is
range ranged within 18 and 30°C.
Press RESET(8) to reestablish the
operation according to SECTION 3
Sensor Failure ALARM Activates when skin - Check the sensor is connected
temperature sensor (or its to the Incubator.
60
FAILURE POSSIBLE CAUSE SOLUTION
cable) is shortcircuited, - Reconnect the sensor or
opencircuited or replace it for another in good
disconnected. condition.
Once solved the SENSOR
FAILURE press RESET key to
continue the treatment.
Circuit Failure ALARM This alarm activates when - Switch the unit off using the
there is an alteration in the POWER ON/OFF key and
logical sequence of the switch it on again with the
Control Module command same key.
microprocessor. - If the unit initiates normally, the
Control Temperature and
functioning mode must be
adjusted (when reinitiating the
operation the Control
temperature returned to its
original value 36,0°C and air
mode).
- If the CIRCUIT FAILURE alarm
is activated again, the
Incubator should be switched
off and AUTOHRIZED
TECHNICAL SERVICE must
be contacted.
Power Failure ALARM This alarm activates when - Check socket condition.
there is an interruption in the - Check for correct main voltage
main power supply. in the power outlet.
- Check command module
There is no electric power. fuses.
Once solved the POWER
The main cable is FAILURE, press RESET key to
disconnected. reestablish the operation.
The equipment is The on/off switch is in the - Put the on/off switch to the ON
unplugged and the OFF position. position.
POWER FAILURE - It failure persists, call
ALARM does not activate The alarm back up battery is AUTHORIZED TECHNICAL
dead. SERVICE.
Air circulation failure Failure of motor fan. - Call AUTHORIZED
ALARM Fan motor is dirty. TECHNICAL SERVICE.
Air filter is dirty. - Clean fan motor.
Air-flow sensor is dirty. - Replace air filter.
- Clean sensor.
Incorrect temperature Obstruction of air circulation. - Remove things interrupting
reading Mattress or mattress tray in normal air circulation.
wrong position. - Verify mattress and mattress
tray positioning.
61
7. Hygiene and Maintenance
Hygiene and disinfection is a task of basic importance in every incubator for the
newborn.
Every time the incubator is unoccupied a complete cleaning and disinfection must be
carried out weekly.
! WARNING
Never attempt to relocate the incubator without having removed all its auxiliary
equipment. Check all oxygen supply systems connected to the incubator have been
turned off or disconnected before beginning any cleaning or maintenance procedure.
Fire risk exists in presence of oxygen enriched atmospheres.
MEDIX incubators are designed and manufactured in such a way that permits easy and
safe hygiene tasks.
All the areas associated with the infant’s environment are accessible without the use of
tools or special devices.
Surfaces are easily cleaned and the materials used are stable under conditions of
normal use and hygiene.
CAUTION
Do not use alcohol or any oil based solvent for cleaning. Alcohol may cause cracks or
breakages to the acrylic hood or any other plastic parts.
Recommended products for cleaning and disinfection
Cleaning and disinfecting the incubators are necessary procedures to prevent and
control infections, whether it be between patients or to reduce the immediate
environmental contamination.
Therefore the election of the cleaning and disinfecting product is essential, which should
also help conserve the integrity of the medical device’s surfaces.
Recommended products for cleaning and disinfecting are:
For cleaning:
• Use medical degree enzymatic detergents. These may be mono-enzymatic, bi-
enzymatic or multi-enzymatic.
• Respect the dilution indicated in the detergent’s container.
For disinfection:
Use products based on:
• Sodium hypochlorite 500 – 1000 ppm
• Ethylic alcohol 70% or isopropyl alcohol 70%
63
IMPORTANT: Some chemical substances included in cleaning and disinfecting products
aggressively and progressively damage the high quality composites and plastics used to
manufacture and encase medical devices. The exposition to these substances may
cause damages which are not always visible. For such reason it is unadvisable to use
chemical products which contain:
• Phenols.
• Formol.
• Glutaraldehyde.
• Clorhexidine.
• Strong organic acids.
• Last generation quaternary ammoniums.
7.1 Hygiene of Power Unit
CAUTION
Always begin with hygiene of the power unit so that when cleaning the rest of the incubator
the power unit is not accidentally wetted.
Figure 25: Power unit dismantling
1 Turn the incubator OFF and unplug it from main power socket.
2 Disconnect the air and skin temperature sensors, and main supply cables.
! WARNING
The heater can be hot enough to cause burns. Wait at least 20 minutes after the POWER
has been turned OFF before removing it from the incubator’s base.
3 20 minutes after turning the incubator off, remove power unit by unscrewing the
two manual knobs and sliding it out as shown in Figure 25: Power unit dismantling .
4 Figure 26: Power unit rear part. 1- Turbine 2- Heater 3- Seal shows the rear part
of the power unit, which is in contact with the air circulating through the infant’s
64
compartment. Deposits of fluff and other types of contamination are normally
found on this part of the unit. The fluff does not arise from the outside air, which
passes through a 0.5 micron filter before entering the incubator, but from
elements used in the care of the infant such as gauzes and cotton wool, and from
the shedding of the infant’s skin. Hygiene of this part of the incubator is very
important to avoid cross contamination.
Figure 26: Power unit rear part. 1- Turbine 2- Heater 3- Seal
5 Remove the turbine as shown in Figure 27: Turbine dismantling and wash and
disinfect it.
Figure 27: Turbine dismantling
6 The heater is hermetic and may be unplugged as shown in Figure 28: Heater
dismantling for washing and disinfecting.
65
Figure 28: Heater dismantling
7 Once the turbine and heater have been removed, clean all exposed surfaces and
sealing ring.
! WARNING
Take care not to allow fluids to enter the rest of the power unit. If in doubt do not reconnect
to electrical supply. Call AUTHORIZED TECHNICAL SERVICE.
8 Reassemble heater and turbine verifying correct installation.
DO NOT REINSERT power unit until the incubator has been cleaned and
disinfected.
! WARNING
Failure to clean turbine and heater elements will result in excessive lint buildup and
reduced airflow. Reduced airflow will affect temperature control and cause high carbon
dioxide (CO2) concentrations.
7.2 Hygiene of Infant’s Compartment
1 Remove the sealing rings from the access ports for cleaning and disinfection.
2 Open the hood for general access, as shown in point “1.7.1.1 General Access”..
See figure 8: Completey opened hood.
3 Remove the mattress for cleaning or replacement. Remove the tray and levers of
tilting mechanism for cleaning and disinfection.
4 Remove main tray as shown in figure 29: Main tray. Clean and disinfect.
CAUTION
The main tray must not be subjected to force when being washed. This could cause it to
become distorted leading to faulty seating on the main base of the incubator. On
reassembly, make sure that the tray is correctly centered and seated, if not, the incubator
may fail to function correctly and alarms may be activated without apparent reason.
66
Figure 29 Main tray
5 Remove the base sealing ring for cleaning and disinfection.
6 In those incubators fitted with the optional humidity control system, remove
the air deflector plate covering the water tank. Clean and disinfect. See
figure 30: Water tank.
7 The main base of the incubator will now be visible as shown in Figure 31: Main
base. Clean and disinfect all exposed surfaces.
Figure 30: Water tank
Figure 31 Main base
67
8 Clean and disinfect all the acrylic hood’s interior surfaces. The use of alcohol is
not recommended, it may cause the acrylic to become opaque. If necessary the
entire hood may be easily removed. To do this, close the hood and unscrew the
two screws (one at each side). Remove the intensive care door so that it does not
fall and lift off the hood carefully.
9 Clean and disinfect the power unit’s housing. See Figure 32: Power unit’s housing.
10 Remove the air microfilter’s cover for cleaning and disinfection. See Figure 33: Air
microfilter’s cover. The cover is removed by unscrewing the two screws at each end
of the cover.
Figure 32: Power unit’s housing
CAUTION
When replacing the cover be sure that it is correctly positioned. Incorrect positioning will
result in oxygen leakage.
Figure 33: Air microfilter’s cover
11 Remove the air microfilter. If it is very dirty or is more than three months old,
dispose and replace it with a new filter.
68
! WARNING
Do not attempt to clean the used air microfilter and do not reinsert the filter with the dirty
side towards the incubator.
12 Clean and disinfect the air duct which goes from the air filter to the power unit’s
housing. If necessary it may be removed by sliding it towards the side of the
power unit. A bottle brush could also be used for cleaning.
13 Proceed with iris port cleaning due to the ease with which it becomes
contaminated in normal use.
a. Dismantle the rubber seal which holds it in position against the side of the
hood.
b) Completely remove the iris port and dismantle it completly for cleaning and
disinfection.
The frequent renewal of the plastic sleeve is recommended because dirt easily
accumulates in its folds.
14 Reassemble the incubator leaving until last the insertion of the power unit,
checking that it is completely dry.
7.3 Changing Air Filter
The air filter is a microfilter made from borosilicate fibers and phenolic resins designed
especially for air filtration. It will not allow the passage of dust particles greater than 0.5
microns diameter (0.0005millimeters). It should be changed every three months in air-
conditioned environments and more frequently in other environments.
! WARNING
Do not attempt to clean the air filter and never replace it in position back-to-front (with the
dirty side facing towards the incubator).
7.4 Cleaning of Oxygen Filter
The oxygen filter must be removed from the incubator for cleaning and disinfecting, then it
must be replaced in position.
7.5 Power Unit Maintenance
With the exception of regular cleaning all repair, recalibration and maintenance must
be carried out by specialized technical personnel. The incubator’s power unit
functions for long periods of time without interruption and so requires preventive
maintenance to guarantee trouble-free service.
69
! WARNING
Perform the functional checking procedure of Section 5 of this manual before operating
the incubator. If a problem is detected during any stage of the Functional Checking
Procedure, the incubator must not be used and the Authorized Technical Service must be
contacted.
7.6 Routine Maintenance Plan
PART When When Daily Every Once Every Authorized Obs.

necessary changing 3(three) a year 2(two) Technical
patient months years Service
required
Cleaning and X (*) Detailed instructions in User
disinfection Manual (Chap.7)
User Functional X Detailed instructions in User
checking procedure Manual Chap.5
Technical Service X X Detailed instructions in
checking procedure Technical Service Manual
Chap.5
DIR-02 X Or when visibly dirty.
Air filter User Manual Chap.7
IV ports X Replace if material
becomes brittle
Iris ports X Disposable
Port sleeves X Disposable
Skin temperature X User Manual Chap.6
sensor User Manual Chap.7
Mattress X User Manual Chap.7
Battery pack #45306 X X Detailed instructions in User
Memory / alarms Manual Chap.1
Motor – Noise test X X Noise level shall be <55dBA
(*) According to Hospital procedure
70
Annex 1: Optional Accessory MEDIX TA-04
Power module TA-04

Includes:
* Two unspillable sealed batteries 24 A/h each one.
* Automatic battery charger and inverter for 220 VAC (or 110 VAC) 50/60 Hz. Complete
recharge time: approx. 9 hours. Lower complete recharge time: on request.
TECHNICAL SPECIFICATOINS: MODULE TA-04:

DIRECT CURRENT: 12 VCC / 25 A
BATERIES: 2 x 12VCC, 24Ah
4 x 12 VCC, 24Ah / on request TA-11
LOW BATTERY ALARM
Fuses
5 A @ 110V-127V
3 A @ 220V-240V
CAUTION
In case of replacement, verify the fuse is of the same type and value that the original one.
Autonomy
2 hours (prewarmed incubator)
4 hours (option TA-11)
Battery recharge time: 9 hs
! WARNING
To save battery life it is recommended to recharge them as often as possible, by connecting the
TA-04 module to line power.
71
Battery Operation Condition
The TA-04 (battery inverter charger module) has a Low Battery alarm, audible and visual.
This alarm starts to flash and sound (sound can be cancelled with the reset button)
approximately 15 minutes before the batteries completely discharge.
When the batteries reach to 10.5 volts, the TA-04 will stop providing energy to protect the
batteries.
At that time, the Main Power Failure Alarm will sound.
TA-04 Battery Inverter/Charger Panel
27 - Main ON/OFF switch.

28 - Connection to Incubator.
29 - Input AC Power cable.
30 - Input DC Power cable to Ambulance battery.
31 - Battery ON indicator (continuous light).
Discharged batteries indicator (blinking light).
32 - Battery charger ON.
33 - Overload DC.
34 - Sound reset.
35 - Fuse AC input
36 - Fuse AC input
37 - Fuse AC output.
72
Main Connections
IMPORTANT: The TR-306 Incubator module always works with 220 Volts Alternating
Current and 50/60Hz (110 VAC 50/60 Hz if applicable).
The 220 VAC50/60Hz (110 VAC50/60Hz) may be supplied by:

a) A 220 VAC50/60Hz (110 VAC50/60Hz) regular hospital outlet. The “line inlet”
indicator on the TA-04 module will remain on.
b) From the TA-O4 energy module, during transport.

The TA-O4 module has 12 VCC batteries (1 or 2, as requested) and converts the 12
Volts Direct Current from the batteries to 220 Volts AC, 50Hz (110 VAC/60Hz) to power
the incubator. The “to the incubator (AC)” indicator on the TA-04 module will remain on.
73
c) From the 12 V.battery provided by the emergency transport.
When the incubator is on emergency transport, the TA-04 module connects to the
transport’s battery and generates the necessary 220 VAC, 50 Hz (110 VAC, 60Hz). The
“12 DC ambulance power cable input” indicator will remain on.
The TA-04 module batteries will be automatically disconnected, thus preserving their
charge.
NOTE: All operations are automatic:
a) When the unit is plugged to the AC (alternate current) hospital outlet, the incubator
will be powered by the hospital mains, and the automatic battery charger (included in
the TA-04 module) will start charging its batteries.
b) When the unit is unplugged from the AC hospital outlet, the TA-04 module
automatically takes over the energy supply to the incubator, using its own batteries.
c) When the unit is connected to the ambulance battery, power is automatically provided
by the ambulance.
In turn, when the unit is disconnected from the ambulance, the TA-04 module
automatically supplies power again, using its own batteries.
Connection to emergency transport’s battery:
Proceed as follows:
a) Turn off the incubator.

b) Turn off the TA-04 module.
c) Connect the 12 V cable to the emergency transport.
d) The emergency transport’s engine must be on from this moment on.
e) Turn on the TA-04 module.
f) Turn on the incubator.
g) Verify the incubator’s control temperature.
This procedure prevents the generation of high transitory currents in the system.
NOTICE: when the unit is not occupied, it is highly recommend to maintain it in the
Nursery in stand by condition, plugged to the hospital AC outlet.
This situation assures that:

a) The unit will be warm and ready when needed.
b) The batteries will be fully charged.
c) Being the unit pre-warned will require less power from the batteries when switched to
transport condition. This will allow longer autonomy under battery operation.
74
NOTE
Due to permanent interest in upgrading its products, the manufacturer reserves its rights to
make changes without prior notice.
75
MEDIX I.C.S.A.
FACTORY, SALES, ADMINISTRATION AND TECHNICAL SERVICE
Calle 89 José Arias 293 TEL.: +54-11-4754 5555

(1672) Villa Lynch - San Martín FAX: +54-11-4754 1713
Buenos Aires e-mail: [email protected]
ARGENTINA http://www.MEDIX.com.ar
77

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Infant Incubator

José Arias 293, Villa Lynch

VOLTAGE 220/240 V~– 50/60 Hz

CLASSIFICATION ACCORDING TO IEC-60601-1 / IEC 60601-2-19 STANDARD

ELECTRIC PROTECTION CLASS I

PROTECTION AGAINST LIQUID IPX0

EQUIPMENT NOT SUITABLE FOR USE IN THE PRESENCE OF FLAMMABLE ANAESTHETIC

PC-305 WITH OPTIO NAL ACCESSORIES

2. Unpacking and Assembly ...................................................................................................................33

4. Command Module Description ........................................................................................................... 43

5. Operating Instructions ........................................................................................................................ 47

7. Hygiene and Maintenance.................................................................................................................. 63

Annex 1: Optional Accessory MEDIX TA-04.................................................................................71

Spare parts provision – Useful life

Legal Representative for CE

Refer to SECTION 5 of this manual before turning on the incubator.

This equipment is not suitable to be used in presence of anaesthetic gases.

The use of oxygen increases the equipment risk of fire.

Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL

This equipment is not designed to function in explosive atmospheres or in the presence of

Set the brakes on the wheels when the incubator is functioning.

Whenever oxygen is administered to the incubator, the resulting concentration must be

Oxygen administration can increase noise level inside the incubator.

International electrical symbols:

SEE USER MANUAL

DANGER – HIGH VOLTAGE

APPLICABLE PART TYPE B

FRAGILE, HANDLE WITH CARE

XXXX: Serial Number

AA: Date of Manufacturing

XXXX: Lot number

The MEDIX PC-305 is a microprocessor-controlled incubator which has been designed to

• Controlled interior atmosphere using heated air, circulating in a closed circuit to

1.2 Basic Equipment

The MEDIX PC-305 is provided with the following elements:

1.3 Cabinet Stands

DIA-31 Cabinet stand with electrical pedal for height

Hygrometer for measurement of interior relative humidity (%)

Humidity control system

Figure 4: Humidity control system

Figure 5: Double wall installation

Figure 6: Oxygen hoods

LEFT side FRONT left BACK left

DIR-02 Air filter (pack x 4)

DIR-04 Access port seal (pack of 4)

DIR-05 Hammock for balance

DIR-06 Iris port sleeves (box x 100)

DIR-10 Skin temperature probe (reusable)

DIR-12 Air temperature probe

DIR-14 Main cable 220/240 V~.

DIR-15 Main cable 110/127 V~

DIR-17 Front IV port (open) (pack x 2 units)

DIR-19 Back IV port (circular) (pack x 2 units)

DIR-20 Port diaphragm (box of 100)

DIR-21 Front door gasket

DIR-22 Base gasket