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 1.25A @ 220/240 V~ 2.5A @ 110/127V~

POWER

CLASSIFICATION ACCORDING TO IEC-60601-1 / IEC 60601-2-19 STANDARD ELECTRIC PROTECTION PROTECTION AGAINST PRESENCE APPLICABLE PART

CLASS I LIQUID IPX0

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

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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 7.3 7.4 7.5 7.6

Hygiene of Infant’s Compartment .................................................................................................. 66 Changing Air Filter......................................................................................................................... 69 Cleaning of Oxygen Filter................................................................................................................... 69 Power Unit Maintenance................................................................................................................. 69 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)

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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

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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.

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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.

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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.

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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.

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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.

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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).

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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.

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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

~

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ALTERNATING CURRENT

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

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Warning Labels Fixed to the Equipment

12

13

Equipment Identification S/Nº: XXXX-AA XXXX: Serial Number AA: Date of Manufacturing

XXXX: Lot number

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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.

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• • 1.2

The incubator provides uninterrupted vision of the infant. Monitor communication possibility through external interface.

Basic Equipment

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

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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.

Figure 1: Basic equipment with DIA-36 cabinet stand 1.3

Cabinet Stands CATALOG DIA-36

DESCRIPTION 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.

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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

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Cabinet stand with two trays, shelf and doors, four wheels, two with brakes.

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

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CATALOG DIA-15

DESCRIPTION Acrylic half cylinder. 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 DIA-28/29

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Nest mattress to protect baby inside the incubator. Auxiliary AC outlet box.

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 NOTE: Right side is exactly symmetric.

DIA-43 DIA-46

BACK left

THIS ACCESSORY IS PLACED INSTEAD OF THE STANDARD TWO POSITION SYSTEM PROVIDED WITH THE EQUIPMENT. Oxygen Servocontrol. Oxygen servocontrol module with support for incubator. Column with IV pole. Monitor shelf for DIA-46.

DIA-47

The monitor or accessory shelf is mounted on column with IV pole (cat.DIA46) 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.

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1.5

Consumables/Replacement parts CATALOG

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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)

DIR-27

PVC spare parts KIT. Includes: front door gasket, 4 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

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 Width Depth

139cm 91cm (without all round fender). 106,5cm (with all round fender). 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: 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~ 110/127V~

50/60 Hz 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.

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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.

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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: 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 1

Air Mode 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 2 3

Repeat steps 1, 2, 3, 4, 5 and 6 of AIR mode. Repeat steps 3 and 4 of SKIN mode. 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) MINIMUM 80% 85% 90%

1 2 3 4

!

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 Skin Temperature ALARM Equipment working in SKIN MODE

POSSIBLE CAUSE Skin temperature differs in +/-1°C from the preset Control Temperature The skin temperature sensor is not correctly attached to the infant’s skin (SKIN mode only) The equipment is in AIR MODE and the skin temperature set is out of range

Sensor Failure ALARM

60

Activates when skin temperature sensor (or its

SOLUTION Check the sensor is correctly located and fixed to the infant’s skin. - Check the patient’s status (i.e. fever). - Check for environmental factors in the nursery room: do not place the Infant Incubator in drafts, close to open windows, air conditioners, radiators or other heat sources. - Check room temperature is ranged within 18 and 30°C. Press RESET(8) to reestablish the operation according to SECTION 3 - Check the sensor is connected to the Incubator. -

FAILURE

POSSIBLE CAUSE cable) is shortcircuited, opencircuited or disconnected.

Circuit Failure ALARM

This alarm activates when there is an alteration in the logical sequence of the Control Module command microprocessor.

Power Failure ALARM

This alarm activates when there is an interruption in the main power supply. There is no electric power.

The equipment is unplugged and the POWER FAILURE ALARM does not activate Air circulation failure ALARM

Incorrect temperature reading

The main cable is disconnected. The on/off switch is in the OFF position. The alarm back up battery is dead. Failure of motor fan. Fan motor is dirty. Air filter is dirty. Air-flow sensor is dirty. Obstruction of air circulation. Mattress or mattress tray in wrong position.

SOLUTION Reconnect the sensor or replace it for another in good condition. Once solved the SENSOR FAILURE press RESET key to continue the treatment. -

Switch the unit off using the POWER ON/OFF key and switch it on again with the same key. - 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. - Check socket condition. - Check for correct main voltage in the power outlet. - Check command module fuses. Once solved the POWER FAILURE, press RESET key to reestablish the operation. - Put the on/off switch to the ON position. - It failure persists, call AUTHORIZED TECHNICAL SERVICE. - Call AUTHORIZED TECHNICAL SERVICE. - Clean fan motor. - Replace air filter. - Clean sensor. - Remove things interrupting normal air circulation. - 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, bienzymatic 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 2

Turn the incubator OFF and unplug it from main power socket. 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 4

64

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 . 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

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 2 3 4

Remove the sealing rings from the access ports for cleaning and disinfection. Open the hood for general access, as shown in point “1.7.1.1 General Access”.. See figure 8: Completey opened hood. Remove the mattress for cleaning or replacement. Remove the tray and levers of tilting mechanism for cleaning and disinfection. 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 6

7

Remove the base sealing ring for cleaning and disinfection. 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. 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 airconditioned 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.

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! 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 necessary

Cleaning and disinfection User Functional checking procedure Technical Service checking procedure DIR-02 Air filter IV ports Iris ports Port sleeves Skin temperature sensor Mattress Battery pack #45306 Memory / alarms Motor – Noise test

Daily

Every 3(three) months

Once a year

Every 2(two) years

Authorized Technical Service required

X (*) X X

X

X X X X X X

(*) According to Hospital procedure

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When changing patient

X

X

X

X

Obs.

Detailed instructions in User Manual (Chap.7) Detailed instructions in User Manual Chap.5 Detailed instructions in Technical Service Manual Chap.5 Or when visibly dirty. User Manual Chap.7 Replace if material becomes brittle Disposable Disposable User Manual Chap.6 User Manual Chap.7 User Manual Chap.7 Detailed instructions in User Manual Chap.1 Noise level shall be