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TRANSPORT INCUBATOR Model: RWT PLUS

USER GUIDE

May 2012 Review 00

No part of this guide may be reproduced or transmitted by any means and for any purpose without written permission of Olidef. The project of this equipment was developed and manufactured exclusively by Olidef cz Indústria e Comércio de Aparelhos Hospitalares Ltda. The Olidef has a policy of continuous improvement of its products and reserves the right to change technical specifications without notice. The images contained herein are merely illustrative. Manufaturer: Olidef cz Indústria e Comércio de Aparelhos Hospitalares Ltda. Avenida Patriarca, 2223 - Ribeirão Preto/SP – Brasil ZIP CODE 14031-580 CNPJ MF 55.983.274/0001-30 State Registration 582.013.221.111 Contacts: Phone: (16) 3919-9350 Fax: (16) 3919-9351 Call Center: 0800 18 3111 E-mail: [email protected] Site: www.olidef.com.br Brazilian Industry ANVISA Registration: 10227180031 Technical Manager:

Paulo Sérgio Gomes CREA: 0601299259/SP

Representative in the European Community: OBELIS S.A. Av.Tervuren, 34 bte 44, B-1040. Brussels, Belgium

Olidef cz Indústria e Comércio de Aparelhos Hospitalares Ltda. declares that this product is in accordance with Brazilian standards, national regulatory bodies and European Council Directives 93/42/EEC concerning medical devices when used according with instructions provided by the user and technical guides.

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TABLE OF CONTENT 1 - Identification.......................................................................................................................... 5 1.1 - Name and model .......................................................................................................... 5 1.2 Product Description......................................................................................................... 5 1.3 Physical Principles .......................................................................................................... 6 1.4 - Accompanying Parts and Accessories .......................................................................... 6 1.4.1 - Dome...................................................................................................................... 7 1.4.2 - Bed with mattress ................................................................................................... 8 1.4.3 - Battery .................................................................................................................... 9 1.4.4 - Second rechargeable battery .................................................................................. 9 1.4.5 - Control Module ....................................................................................................... 9 1.4.6 - Air filter ................................................................................................................... 10 1.4.7 - Humidification Sponge ............................................................................................ 10 1.4.8 - Limiting oxygen valve.............................................................................................. 11 1.4.9 - Passive oxygen valve ............................................................................................. 11 1.4.10 - Integral bumper..................................................................................................... 12 1.4.11 - Auxiliary Lighting................................................................................................... 12 1.4.12 - Carriage with height adjustment............................................................................ 12 1.4.13 - Serum Holder........................................................................................................ 13 1.4.14 - NB sensor............................................................................................................. 13 1.4.15 - Spanner ................................................................................................................ 13 1.4.16 - Regulating valve ................................................................................................... 14 1.4.17 - Fluxometer............................................................................................................ 14 1.4.18 - Dual-socket........................................................................................................... 14 1.4.19 - Oxygen Hose ........................................................................................................ 14 1.5 - Optional, accessories and consumables....................................................................... 15 1.5.1 - Servo controlled system for humidity ...................................................................... 15 1.5.2 - Servo controlled system for oxygen ........................................................................ 15 1.5.3 - Integrated Oxymetry System................................................................................... 16 1.5.4 - Extender Cable for oxymetry sensor ....................................................................... 17 1.5.5 - Type-Y Oxymetry Sensor........................................................................................ 18 1.5.6 - Dome with dual strainer .......................................................................................... 18 1.5.7 - Holder of smaller monitor........................................................................................ 19 1.5.8 - Holder of greater monitor ........................................................................................ 20 1.5.9 - Fixing lock system .................................................................................................. 20 1.5.10 - Gurney.................................................................................................................. 20 1.5.11 - Carriage with no height adjustment....................................................................... 21 1.5.12 - Caster of 6”........................................................................................................... 21 -2-

1.5.13 - Battery in accordance with Rohs Directive ............................................................ 21 1.5.14 - Voltage converter.................................................................................................. 22 1.5.15 - Disposable NB sensor .......................................................................................... 22 1.5.16 - Auxiliary temperature sensor ................................................................................ 22 1.5.17 - Cover of autoclavable mattress............................................................................. 22 1.5.18 - Gel mattress ......................................................................................................... 23 1.5.19 - Adapter of ventilation tube .................................................................................... 23 1.5.20 - Triple Scale Set .................................................................................................... 23 1.5.21 - Nebulizer .............................................................................................................. 24 1.5.22 - Manual Reanimator............................................................................................... 24 1.5.23 - Oxygen Hood........................................................................................................ 24 1.5.24 - Gas cylinders ........................................................................................................ 25 1.5.25 - Air filter ................................................................................................................. 25 1.5.26 - Adhesives for oxymetry sensor ............................................................................. 26 1.5.27 - Adhesives for NB sensor ...................................................................................... 26 1.6. Technical Specifications ................................................................................................ 26 1.6.1 - Symbols used in the equipment .............................................................................. 28 2 - Special Conditions of product storage, preservation and/or handling ............................. 29 2.1 - Before installation ......................................................................................................... 29 2.2. - After installation ........................................................................................................... 30 3 - Warnings and/or precautions to be adopted....................................................................... 30 3.1 - Oxygen ......................................................................................................................... 32 3.2 - Integrated xymetry ........................................................................................................ 32 4 - Performances on essential safety and efficacy requirements of medical products ........ 32 4.1 - Indication, purpose or use for which the product is intended......................................... 32 4.2 - Product safety and efficacy........................................................................................... 33 5 - Use with other equipment .................................................................................................... 35 6 - Installation and maintenance ............................................................................................... 36 6.1 - Equipment installation................................................................................................... 36 6.1.1 - Unpacking............................................................................................................... 36 6.1.2. - Preliminary Verification .......................................................................................... 36 6.1.3 - Equipment assembly............................................................................................... 36 6.1.4 - Installing the cylinders............................................................................................. 38 6.1.5 - Installing the integrated oximetry system (optional)................................................. 39 6.1.6 - Installing the nebulizer (optional) ............................................................................ 40 6.1.7 - Installing gurney in a vehicle (optional) ................................................................... 40 6.2 - Turning on the transport incubator - Model RWT PLUS ................................................ 44 6.2.1 - Use of AR mode ..................................................................................................... 44 6.2.2 - Use of NB mode ..................................................................................................... 45 -3-

6.2.3 - Humidity Control ..................................................................................................... 47 6.2.4 - Oxygen Control....................................................................................................... 50 6.2.5 - Oximetry of Integrated Pulse (optional module) ...................................................... 54 6.2.6 - Trend Graphics ....................................................................................................... 57 6.3 - Additional Resources.................................................................................................... 59 6.3.1 - Keypad lock ............................................................................................................ 59 6.3.2 - Date and Time ........................................................................................................ 60 6.3.3 - Registry of patients ................................................................................................. 61 6.3.4 - Environment temperature ....................................................................................... 62 6.3.5 - Battery Charge........................................................................................................ 62 6.4 - Alarms operation .......................................................................................................... 63 6.5 - Check of alarm system ................................................................................................. 68 7 - Maintenance .......................................................................................................................... 69 7.1 - Preventive Maintenance ............................................................................................... 69 7.2 - Periodic Maintenance ................................................................................................... 70 7.2.1 - Replacing the AIR filter ........................................................................................... 71 7.2.2 - Replacing the air filter of the passive oxygen valve ................................................. 71 7.2.3 - Replacing the air filter of the limiting oxygen valve .................................................. 71 7.2.4 - Replacing the air filter of the servo controlled oxygen valve .................................... 72 8 - Cleaning and disinfection..................................................................................................... 72 8.1 - Cleaning ....................................................................................................................... 72 8.2 - Disinfection ................................................................................................................... 78 9 - Troubleshooting.................................................................................................................... 78 10 - Warranty .............................................................................................................................. 79

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1 - IDENTIFICATION 1.1 - - NAME AND MODEL Technical name: Transport Incubator Trade name: Transport Incubator Trade Model: RWT PLUS

Figure 1 - Transport incubator RWT PLUS

1.2 PRODUCT DESCRIPTION The Transport Incubator - model RWT PLUS is designed to transport a high risk of premature with low weight or newborns with serious illnesses. The equipment has two operating modes: AR temperature control (ATC) and NB temperature control (ITC). In AR mode the transport incubator maintain the air temperature stable inside the newborn compartment, comparing the air temperature within the dome with the temperature control set by the operator. If the air temperature is high, the heating is turned off until the air temperature falls below the value preset by the operator. In the NB mode the transport incubator sets the warming based on the temperature value read to the newborn skin and NB temperature set by the operator. To maintain constant the patient temperature, near the value set by the operator, the control panel of the incubator will compare the temperature measured by the NB sensor with the temperature set by the operator increasing or decreasing the air temperature inside the incubator as variation of the patient skin temperature. The NB compartment has a dome with double-wall in high strength transparent acrylic equipped with two doors (front and side), plus tube passages with flexible sealing system. The front access door with two portholes with wrist sleeve and a side door with iris sleeve offers a complete opening for procedures in the newborn. The patient's bed has safety belts that should involve during transport of the patient. It can be moved out of the dome through guides facilitating the access to the newborn for additional procedures. With extremely quiet operation resulting in less discomfort for the patient, this incubator offers temperature control in AR and NB modes optional as servocontrolled functions of relative air humidity and oxygen concentration, achieving high concentrations of air humidity and oxygen, respectivelly, inside the newborn compartment, and integrated pulse oximetry, front control panel with color graphic display of 7" widescreen which summarizes all the options and monitoring setting with trend graphics for treatment and diagnosis through an interactive menu, you can interact via membrane keyboard, touchescreen and spinknob. The equipment is also equipped with auxiliary lighting to enhance the patient visualization in dark environments. -5-

The incubator was built to operate at power supply of 120-230V~ or external voltage of 12V ...... from ambulances and can also operate with internal batteries which can provide up to 330 minutes (optional) of operation autonomy. Batteries are charged constantly wen the unit is connected to the mains. Optionally, an adapter can be coupled to the incubator allowing the equipment to operate with voltage between 12 and 48 Vdc, allowing the incubator use at the site where this supply voltage is available. The transport incubator RWT PLUS can also be removed from its holder with casters and be coupled directly to the gurney with adjustable or fixed height keeping the standard of fixing system existing in the ambulance already. It also has the locking system for fixing to the ambulance floor as a feature, which allows the transport incubator to be locked inside the vehicle.

1.3 PHYSICAL PRINCIPLES The transport incubator - RWT PLUS model consists of a body built with engineering plastic materials in order to hold a human newborn (NB), Allowing its visualization through a transparent acrylic dome with double wall. Inside the newborn compartment, the environmental conditions can be maintained according to the NB needs by maintaining the air heating, increasing the oxygen concentration and relative humidity beyond soundproofing and low noise level produced by the equipment. To ensure the best environmental conditions for the patient, the air and oxygen admitted into the equipment are independently filtered to prevent the passage of particles larger than 0.5 microns, providing an inside air built with the highest purity and the temperature controls, humidity and oxygen from the incubator are performed by the forced air circulation system where a controlled amount of air is sucked by an engine through the intake air filter, humidified and enriched with oxygen is distributed uniformly to the control environment of the newborn compartment. This system keeps the internal air circulation micro filtered and duly heated; this air flow passes directly from the sensors of temperature, humidity and oxygen control, and such system also prevents the accumulation of carbon dioxide inside the compartment.

1.4 - ACCOMPANYING PARTS AND ACCESSORIES:

Figure 2 - Isometric front view of the Transport Incubator RWT PLUS

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Figure 3 - Isometric rear view of the Transport Incubator RWT PLUS

1 2 3 4 5 6 7 8 9 10 11 12 13

Body Control module with commands in the touchescreen display, spinknob and membrane keyboard Cylinder Holder (2x) Acrylic dome Bumper Holder with casters Casters of 5” with lock (4x) Porthole with touch-of-elbow Holder lock Current inlet panel Air filter Module panel of sensors Servo controlled Oxygen Valve

14 15 16 17 18 19 20 21 22 23 24 25 26

Limiting Oxygen Valve Coupler for nebulizer Main key Mini resettable circuit breaker (2x) Auxiliary Power connector 12V AC Power connector Module connector of sensors NB sensor connector Sensor connector for oxymetry External temperature sensor Module of sensors Water tank Drawer Latch

1.4.1 - DOME External Dome The External Dome of the Transport Incubator RWT PLUS is built on transparent acrylic and has two access doors (front and side). The front door has two openings for passage of hands and wrist with fist-sleeves and oval portholes with nontoxic silicone sealing activated by touch of an elbow. The side door has an opening for tubes' system with iris sleeve. The dome also has passages for flexible cables.

Figure 4 - Dome

A - EXTERNAL DOME: Built in transparent acrylic, equipped with double wall, front access door, passages for hands with oval portholes (E), passage for tube system of iris sleeve (F) and tube passages (D). B - LATCH: To open the access doors, turn the latches (B). C - DUAL STRAINER: Positioned on the right side of the dome, allows the passage of tubes in the newborn compartment.

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D - PASSAGES OF TUBES: Positioned in an easy access location at the opening of intensive care cover, these devices are used for tube and cable passage, allowing the NB easy removal with no need of these devices' removal (4 tube passages are installed at the incubator RWT PLUS dome - considering the double strainer (C)). E - PORTHOLES: Built in transparent plastic materials with high mechanical strength, they have flexible silicone sealing and removable fist-sleeve which provide perfect sealing and prevent abrupt changes of air temperature in the NB compartment. The portholes' opening is made by a latch activated by the touch of an elbow, avoiding hand contamination before entering the patient. F - IRIS PORTHOLE: It allows the passage of tubes in the newborn compartment. G - COUPLER OF NEBULIZER: Device located on the left side of the dome, allowing adaptation of the external nebulizer. It has plastic cover that shall be closed when the coupler is not being used. H - FRONT COVER: It allows quick and safe access to the patient minimizing heat losses inside the NB compartment. To open the cover, you must activate the latches located in its upper part (B). I - SIDE COVER: Cover located in the right side of the dome allows quick and safe access to the patient, minimizing heat losses inside the NB compartment. To open the cover, you must activate the latches located in its upper part (B). Note: The dome may change the number of portholes, covers and openings according to the customer needs.

Internal Dome Built in transparent acrylic, the internal dome shapes a double wall system, together with the dome, with improved heat insulation ability, allowing the reduction of heat losses inside the newborn compartment, making it easier to maintain the patient temperature.

Figure 5 - Internal dome

A B C

Internal Dome Passages of tubes Double strainer

1.4.2 - BED WITH MATTRESS The patient's bed has 3 mattresses with seatbelts and can be moved up to 24 cm out of the dome coming out from the side access door. The safety lock prevents the full output of the bed as shown in Figure 6.

Figure 6 - Mattress Bed

CAUTION - The maximum load on the bed should not exceed 10 kg.

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1.4.3 - BATTERY The transport incubator RWT PLUS has a gelatinous type rechargeable battery 12Vcc and a load system. The charger keeps the battery constantly charging if the incubator has the main key of the current inlet panel into the ON position and the power cable is connected to the mains. The battery charge electronic circuit allows the device to remain connected in the mains indefinitely with no harming to the battery. The battery provides minimum autonomy of 240 minutes of operation for the transport incubator and estimated useful life of 200 cycles of loading/unloading. CAUTION - When the incubator is connected to an external voltage 12V it will not charge the battery, but this condition will not also have its load consumed.

1.4.4 - SECOND RECHARGEABLE BATTERY The transport incubator RWT PLUS model has a rechargeable Nickel Cadium (NiCd - 9V) battery which has the function to keep the system in operation limited to issuance of battery shortage alarm. This battery is automatically recharged when the equipment is plugged into a socket and its life is 12 months. After this time the battery should be replaced by a new original one. CAUTION - Do not use common or alkaline battery. The replacement should be performed by trained personnel.

1.4.5 - CONTROL MODULE The control module consists of a chassis containing all electronic circuits responsible for monitoring and control of air temperature in the newborn compartment, as well as indication of security alarms. Panel with color graphic display of 7" widescreen with activation through touchscreen, membrane keypad and spinknob.

Figure 7 - Control module

Figure 8 - Membrane keyboard

1-

ALARM ON LED indicator

2-

POWER FAILURE LED indicator

3-

ON/OFF key

4-

Connector for USB Cable

5-

Increase and Decrease parameters Key (Touchscreen)

6-

“ENTER” Key

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7-

“SILENT ALARM” Key

8-

"KEYBOARD LOCK" Key

9-

“>37ºC” Key

10-

SPINKNOB

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Color Graphic display of 7" widescreen with activation through touchscreen

1.4.6 - AIR FILTER The air filter located at the rear of the incubator has the function to filter the air that will enter into the NB compartment. Particles larger than 0.5 micra will not go through the air filter, thus ensuring a high degree of purity inside the newborn compartment.

Figure 9 - Location of air filter

CAUTION - The openings in the filter cover are used for air inlet and should not be obstructed. - It is recommended to change the air filter every ninety days. See item 7.2.1 - Replacing the air filter - The dirty air filter results in the increase of carbon dioxide higher than the oxygen level inside the incubator.

1.4.7 - HUMIDIFICATION SPONGE It is made with nontoxic material that absorbs water so it does not drain inside the equipment during transport, thus increasing the relative humidity within the NB compartment.

Figure 10 - Passive humidification sponge

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1.4.8- LIMITING OXYGEN VALVE (Accessory exclusive for incubator RWT PLUS) The incubator RWT PLUS has an oxygen inlet valve located on the right rear as shown below. It is composed by inlet nozzle for ¼" hose, a filter for retaining impurities and a mechanical system to block the O2 inlet when the flow exceeds 8Lpm.

Figure 11 - Location of limiting valve

Note: The valve can leave the manufacture set to other flows according to the customer request. Note: - To replace the filter see item 7.2.3 - Replacing the air filter of the limiting oxygen valve

1.4.9- PASSIVE OXYGEN VALVE (Accessory exclusive for incubator RWT PLUS) The incubator RWT PLUS has a passive oxygen inlet located on the left side as shown in the figure below. It is composed by a threaded inlet connection 9/16" - 18UNF, a filter for retaining impurities and a mechanical system to block the O2 inlet when the flow exceeds 32Lpm.

Note: - We recommend the use of pressure control valve and a flow meter (with the equipment). - When the incubator leaves with an oxygen servo control system this possibility does not exist - To replace the filter see item 7.2.2 - Replacing the air filter of the passive oxygen valve

Figure 12 - Location of passive valve

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1.4.10- INTEGRAL BUMPER (Accessory exclusive for incubator RWT PLUS) It provides protection all around the incubator perimeter protecting it from impacts. It can also be used as transport handle from the incubator. Built in stainless steel.

Figure 13 - Bumper

1.4.11- AUXILIARY LIGHTING (Accessory exclusive for incubator RWT PLUS) It consists of a white LED lamp with high power that allows the patient visualization in environments with little or no lighting. It has an independent switch without the need of the incubator's operation, energized only.

Figure 14 - Auxiliary Lighting

1.4.12- CARRIAGE WITH HEIGHT ADJUSTMENT (Accessory exclusive for incubator RWT PLUS) Carriage manufactured in aluminum with height adjustment system and mechanical protection system which protects the incubator against impacts. It has shock absorbers to reduce the speed and impact during the height adjustment and four 5" casters with locks.

Figure 15 - Holder carriage

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1.4.13 - SERUM HOLDER (Accessory exclusive for incubator RWT PLUS) This holder is for bags or ampoules of serum. It has two or four hooks for fixing with height adjustment. Total length of 400 mm, maximum height sense of 1900mm from the floor and a minimum of 1500 mm.

Figure 16 - Serum holder

CAUTION - Maximum weight: 1 kg per hook

1.4.14 - NB SENSOR (Accessory exclusive for incubator RWT PLUS) The NB sensor (Figure 17) measures the patient skin temperature providing accurate and reliable reading. The appropriate thermal contact of sensor with the newborn skin is essential for accurate reading of the patient temperature. If this contact is not perfect, there may be a false temperature reading. The patient skin temperature indication is taken by the control module. The skin temperature sensor provides an advanced architecture and makes the patient fixing system simpler but more stable and efficient at the same time. Its isolation system between the skin and the environment allows a safe and reliable measurement, ideal for working in different fields and areas obtaining better results.

1- Skin sensor 2- Cable 3- 4-way connector (Note: To the O2 servo controlled system, the connector will be a P2) Figure 17 - NB Sensor

1.4.15- SPANNER (Accessory exclusive for incubator RWT PLUS) This spanner is used to replace the regulating valve in cylinders of O2 or compressed air. Built in polished chrome vanadium steel.

Figure 18 - Spanner

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1.4.16- REGULATING VALVE (Accessory exclusive for incubator RWT PLUS) Component intended to limit the maximum inlet pressure activated of O2 and compressed air in 3.5Kgf/cm². It has a coupled manometer. Other pressures may be regulated by request to the manufacture.

Figure 19 - Regulating valve

1.4.17- FLUXOMETER (Accessory exclusive for incubator RWT PLUS) Component responsible for manual control of O2 and compressed air concentration ranging from 0 to 15L/min.

Figure 20 - Fluxometer

1.4.18 - DUAL-SOCKET (Accessory exclusive for incubator RWT PLUS) This accessory may be coupled directly to the mains or oxygen/compressed air cylinder and 2 outlet nozzles with threaded 9/16" connection - 18UNF where oxygen or compressed air hoses are connected.

Figure 21 - Dual-socket

1.4.19 - OXYGEN HOSE (Accessory exclusive for incubator RWT PLUS) Nontoxic pressure hose of braided nylon 150PSI with threaded 9/16 connections - 18UNF and length of 1.5 m.

Figure 22 - Nylon Braided 150 PSI Hose

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1.5 - OPTIONAL, ACCESSORIES AND CONSUMABLES Note: - The optional, accessories and consumables for non-exclusive use described in this guide have own records at ANVISA, but are not, therefore, an integral part of the incubator RWT PLUS record. - Before using the accessories, please read the instructions in this chapter.

1.5.1 - SERVO CONTROLLED SYSTEM FOR HUMIDITY (optional exclusive for incubator RWT PLUS) This system allows monitoring and control of air relative humidity within the newborn compartment. Humidity is generated by the piezoelectric pellets system through cavitation, generates micro-bubbles that bursts and evaporates; the humid air passes through the heater before entering the circulating air of the incubator, not changing the environment temperature of the newborn compartment, thereby leaving a stable environment with uniform distribution of heat. This system minimizes heat losses by evaporation, especially for prematures. There is no need for external humidification to humidify the newborn compartment. The entire system has a removable and autoclavable inner plastic tank and an outer plastic tank with 1L capacity with complete exhaustion of water after use with easy and practical access to the entire system for disinfection and sterilization. Adjustments can be made in increments of 1 % every touch as guidance of medical attendant. The range of humidity control ranges from 20% to 95%. The desired concentration and the current value are displayed in the graphic display of the control module.

Figure 23 - Autoclavable water tank (121°C) for 20 min.

Figure 24 - Graphic display - humidity control

Note: - Optional item.

1.5.2 - SERVO CONTROLLED SYSTEM FOR OXYGEN (optional exclusive for incubator RWT PLUS) The use of this system allows monitoring and control of oxygen concentration within the newborn compartment. The system consists of threaded inlet 9/16" connection - 18UNF, a filter for retention of impurities, mechanical system that limits the inlet pressure to 3.5 kgf/cm², solenoid valve that limits the flow to 32 Lpm and accuracy sensors. - 15 -

The desired concentration and the current value are displayed in the graphic display of the control module and are incremented by 1% every touch. The adjustments should follow the guidance of the medical attendant. The oxygen control range is from 21% to 65% with a maximum pressure of 3.5 kgf/cm² and a maximum flow of 32Lpm. To enhance the patient safety, many alarms are available when this optional is installed in the incubator.

Figure 25 - Location of the servo controlled inlet of oxygen - threaded 9/16" connection - 18UNF

Figure 26 - Graphic display of oxygen control system

Note: - Optional item.

1.5.3 - INTEGRATED OXYMETRY SYSTEM (optional exclusive for incubator RWT PLUS) This item is available regardless other options comprising a pair of reusable sensors, adhesives' kit for attachment and an electronic board. It is a pulse oximeter to be used as continuous non-invasive monitor of blood oxygen saturation (SpO2) and pulse rate that operates with the application of a sensor containing a dual light source and a photo detector to a pulsatile arterial vascular bed, for example, the finger. The use of oximetry system allows the patient's vital parameters visualization in the control panel display of the incubator: -

Heart Rate (BPM) Rate of saturated hemoglobin with oxygen in the blood (SpO2) Plethysmographic Curve

The oximetry system allows the increase of one unit to set the limits of maximum and minimum ranges of SpO2 and BPM alarms' activation as guidance of medical attendant. The monitoring range of SpO2 ranges from 0 to 100% and the maximum and minimum limits of alarms activation from 0 to 100% may be adjusted. - 16 -

The monitoring range of BPM ranges from 20 to 250 bpm and the maximum and minimum limits of alarms activation from 0 to 250 bpm may be adjusted. Visualization of parameters monitored by oximetry system:

Figure 27 - Display of Control Module

Figure 28 - Oximetry Sensor 1

Figure 29- Oximetry Sensor 2

Note: - Optional item.

1.5.4 - EXTENDER CABLE FOR OXYMETRY SENSOR (Accessory exclusive for incubator RWT PLUS) The use of this extender allows the increase of the oximetry sensor cable length. To use the extender, connect the panel module of sensors from the incubator and other end directly into the sensor cable.

Figure 30 - Cable Extender

Note: - Optional item.

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1.5.5 - TYPE-Y OXYMETRY SENSOR (Accessory exclusive for incubator RWT PLUS) It has the same function of the conventional oximetry sensor allowing a reliable and accurate reading of the patient's vital parameters.

Figure 31 - Type-Y Sensor

Note: - Optional item.

1.5.6 - DOME WITH DUAL STRAINER (optional exclusive for incubator RWT PLUS)

External Dome The External Dome of the Transport Incubator RWT PLUS is built on clear acrylic and has two access doors ( front and side). The front door has two openings for passage of hands and wrist with fist-sleeves and oval portholes with nontoxic silicone sealing activated by touch of an elbow. The side door has an opening for passage of dual tubes. The dome also has passages for flexible cables.

Figure 32 - Dome with dual strainer

A - EXTERNAL DOME: Built in clear acrylic, equipped with double wall, front access door, passages for hands with oval portholes (E), dual strainer (F) and tube passages (D). B - LATCH: To open the access doors, turn the latches (B). C - DUAL STRAINER: Positioned on the right side of the dome, allows the passage of tubes in the newborn compartment. D - PASSAGES OF TUBES: Positioned in an easy access location at the opening of intensive care cover, these devices are used for tube and cable passage, allowing the NB easy removal with no need of these devices' removal (up to 6 tube passages may be installed at the dome of the incubator RWT PLUS - considering the double strainer C). E - PORTHOLES: Built in transparent plastic materials with high mechanical strength, they have flexible silicone sealing and removable fist-sleeve which provide perfect sealing and prevent abrupt changes of air temperature in the NB compartment. The portholes' opening is made by a latch triggered by the touch of an elbow, avoiding hand contamination before entering the patient. F - SIDE COVER: Cover located in the right side of the dome allows quick and safe access to the patient, minimizing heat losses inside the NB compartment. To open the cover, you must trigger the latches located in its upper part (B). G - COUPLER OF NEBULIZER: Device located on the left side of the dome, allowing adaptation of the external nebulizer. It has plastic cover that shall be closed when the coupler is not being used.

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H - FRONT COVER: It allows quick and safe access to the patient minimizing heat losses inside the NB compartment. To open the cover, you must trigger the latches located in its upper part (B). Note: The dome may change the number of portholes, covers and openings according to the customer needs.

Internal Dome Built in transparent acrylic, the internal dome shapes a double wall system, together with the dome, with improved heat insulation ability, allowing the reduction of heat losses inside the newborn compartment, making it easier to maintain the patient temperature.

Figure 33 - Internal dome

A B C

Internal Dome Passages of tubes Double strainer

Note: - Optional item.

1.5.7 - HOLDER OF SMALLER MONITOR (Accessory exclusive for incubator RWT PLUS) This accessory provides a surface with two adjustable safety belts for placement of monitors, infusion pumps and other objects. It may be made with painted carbon steel, painted or polished stainless steel.

Figure 34 - Holder of smaller monitor

CAUTION - Maximum load: 10Kg

Note: - Optional item.

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1.5.8 - HOLDER OF GREATER MONITOR (Accessory exclusive for incubator RWT PLUS) This accessory provides a surface with four adjustable safety belts for placement of monitors, infusion pumps and other objects. It may be made with painted carbon steel, painted or polished stainless steel.

Figure 35 - Holder of greater monitor

CAUTION - Maximum load: 10Kg

Note: - Optional item.

1.5.9 - FIXING LOCK SYSTEM (Accessory exclusive for incubator RWT PLUS) Fixing system developed for the transport incubator fixation using the carriage with height adjustment and fixed on the vehicle floor all built in aluminum.

Figure 36 - Fixing holder of carriage with height adjustment and fixed Note: Other fixing systems may be developed and incorporated into transport incubator based on studies and technical analysis of feasibility for each transport model.

Note: - Optional item.

1.5.10 - GURNEY (Accessory exclusive for incubator RWT PLUS) This accessory built in metal tubular structure in aluminum and casters of 5" with locks allows the incubator to be coupled in a safe and practical way making it easy to use in vehicles. The gurney has a retractable system with height adjustment and protection system around its perimeter that protects the incubator against impacts. The two trays located at the ends of the gurney may be used as holder of support equipment (monitors, oximeters, infusion pumps, fans, etc.) and fixation of such equipment, and also be used as fixing straps. Along with the gurney a system for locks to the equipment fixation inside the vehicle is provided as shown in figure 38. - 20 -

Figure 37 - Gurney Note:

Figure 38 - Fixing holder of gurney

It should be informed the height between the ground and the ambulance floor for gurney definition. - Optional gurney for ambulance coupling provided with adaptation holder for fixing the main body with reversibility - Other coupling systems may be developed and incorporated to the transport incubator based on studies and technical analysis of feasibility for each transport model.

Note: - Optional item.

1.5.11- CARRIAGE WITH NO HEIGHT ADJUSTMENT (Accessory exclusive for incubator RWT PLUS) Carriage manufactured in aluminum with castors of 5" with locks. It has no system with height adjustment. It has a mechanical protection system which protects the incubator against impacts.

Note: - Optional item.

1.5.12- CASTER OF 6” (optional exclusive for incubator RWT PLUS) Casters are supplied with the equipment: carriage with height adjustment, gurney and carriage with no height adjustment can be replaced by others with a diameter of 6 inches. In addition to provide less effort to move the device, it increases the incubator height in 45 mm. Note: All casters provided for transport incubator RWT PLUS have locks.

Note: - Optional item.

1.5.13 - BATTERY IN ACCORDANCE WITH ROHS DIRECTIVE (optional exclusive for incubator RWT PLUS) This battery meets the European Council directives and complies with Rohs Directive, i.e., its parts and materials are Rohs complice. It is a rechargeable battery of 12Vcc, the charger keeps the battery constantly charging if the incubator has the main key of the current inlet panel into the ON position and the power cable is connected to the mains. The battery charge electronic circuit allows the device to remain connected in the mains indefinitely with no harming to the battery. The battery provides minimum autonomy of 330 minutes of operation for the transport incubator and estimated useful life of 500 cycles of loading/unloading. CAUTION - 330 minutes at room temperature of 20-25°C with servo control of active air temperature only and controlling 34ºC with doors and portholes closed and the seals in good condition.

Note: - Optional item.

- 21 -

1.5.14 - VOLTAGE CONVERTER (optional exclusive for incubator RWT PLUS) This accessory is designed to be coupled to the incubator allowing power between 12 and 48 Vdc. Its use is critical when the need to power the incubator in transport means that have voltage between 12Vdc to 48Vdc.

Note: - Optional item.

1.5.15 - DISPOSABLE NB SENSOR (optional exclusive for incubator RWT PLUS) It has the same function as the NB conventional sensor but showing the single-use feature.

Figure 39 - Disposable sensor

Note: - Optional item.

1.5.16 - AUXILIARY TEMPERATURE SENSOR (optional exclusive for incubator RWT PLUS) It allows the reading of patient's peripheral temperature or the air temperature.

Figure 4- = Auxiliary sensor

Note: - Optional item.

1.5.17 - COVER OF AUTOCLAVABLE MATTRESS (optional exclusive for incubator RWT PLUS) This cover can be used in place of conventional plastic cover. It presents external finishing in cotton and inner waterproof, nontoxic and washable material. The use exempts sheets for coating the mattress. The cover for the mattress may be sterilized by autoclaving process at temperatures up to 121°C for 20 min.

Figure 41 - Cover of autoclavable mattress

Note: - Optional item. - 22 -

1.5.18- GEL MATTRESS (optional exclusive for incubator RWT PLUS) It offers greater comfort for patients, including assisting the maintenance of body temperature.

Figure 42 - Gel mattress

Note: - Optional item.

1.5.19 - ADAPTER OF VENTILATION TUBE (Accessory exclusive for incubator RWT PLUS) This accessory allows that ventilation tubes are installed safely and comfortably. For easy positioning, the tube adapter is composed of a flexible rod installed inside the newborn compartment.

Figure 43 - Adapter of ventilation tube

Note: - Optional item.

1.5.20 - TRIPLE SCALE SET (Accessory exclusive for incubator RWT PLUS) This accessory can be attached directly to the oxygen or compressed air mains of the hospital and/or ambulance and it has 3 outlet nozzles with valve. With the triple scale set are provided two flowmeters, a nebulizer and a vial for aspiration.

A - inlet nozzle B - Register C - Scale outlet Note: Connections A and C have thread 9/16" - 18UNF when used for O2 and 3/4" - 16 UNF for compressed air.

Figure 44 - Triple Scale

Note: - Optional item. - 23 -

1.5.21- NEBULIZER (Accessory exclusive for incubator RWT PLUS) The use of this accessory in the transport incubator increases the air humidity concentration inside the newborn compartment. Plastic container with maximum capacity of 300ml, and has a hose with thread 9/16" connection - 18UNF.

1 - Connection for compressed air mains 2 - Water Tank 3 - Connection for incubator dome

Figure 45 - Nebulizer

Note: - Optional item.

1.5.22 - MANUAL REANIMATOR (Accessory not exclusive for incubator RWT PLUS) It has its own registration with ANVISA No.: 10432300009) This accessory consists of a self-inflating sphere in autoclavable vinyl, face mask with polycarbonate bowl and cushion of inflatable vinyl, inlet connection for oxygen supply, unidirectional polycarbonate valve with safety valve. It can be provided in two sizes (1 and 2)

Figure 46 - Manual reanimator

Note: - Optional item.

1.5.23 - OXYGEN HOOD (Accessory not exclusive for incubator RWT PLUS) It has its own registration with ANVISA No.: 10227180030). The Oxygen hood is formed by a cylindrical body and a removable cover built in transparent acrylic. The use of this accessory is intended to provide comfort and proper oxygen concentration for the patient. The oxygen inlet is made through a polycarbonate inlet nozzle located in the hood body. A hole located in the cover and other two lateral passages located in the hood body prevent the CO2 formation in case of oxygen failure.

- 24 -

1. Cover hole 2. Cover 3. Oxygen inlet nozzle for hose of Ø 1/4 “

4. Hood body 5. Side passage

Figure 47 - Hood

The hood can be supplied in three different sizes for patients of different body weights: Size

NB Weight

Small Medium Large

< 1000g 1000g to 3600g > 3600g

Note: - Optional item.

1.5.24 - GAS CYLINDERS (optional not exclusive for incubator RWT PLUS) Oxygen cylinders and compressed air cylinders can be: GAS

CYLINDER SPECIFICATION

CYLINDER VOLUME

WEIGHT W/ NO LOAD

WEIGHT W/ LOAD

OXYGEN OXYGEN OXYGEN OXYGEN COMPRESSED AIR COMPRESSED AIR COMPRESSED AIR COMPRESSED AIR

DOT 3AA (STEEL OR ALUMINUM) DOT 3AA (STEEL OR ALUMINUM) DOT 3AL DOT 3AL DOT 3AA (STEEL OR ALUMINUM) DOT 3AA (STEEL OR ALUMINUM) DOT 3AL DOT 3AL

D TYPE E TYPE D TYPE E TYPE D TYPE E TYPE D TYPE E TYPE

2,8 Kg 3,9 Kg 3,9 Kg 5,5 Kg 2,8 Kg 3,9 Kg 3,9 Kg 5,5 Kg

3,5 Kg 4,8 Kg 4,9 Kg 6,7 Kg 3,5 Kg 4,8 Kg 4,9 Kg 6,7 Kg

Note: - Optional item.

CONSUMABLES 1.5.25 - AIR FILTER (consumables exclusive for incubator RWT PLUS) The incubator RWT PLUS has an air filter whose function is to remove impurities of the air being introduced into the newborn compartment. This filter should be replaced at periods shorter than 90 days or whenever the incubator receives a patient with an infectious disease. Filters are used exclusively for incubators RWT PLUS. To ensure the perfect functioning and an environmental conditions ideal for the patient, use original air filters Olidef only. The filters are available in packs of 2 or 10 units. See item 7.2.1 - Replacing the air filter.

Note: - Optional item.

- 25 -

1.5.26 - ADHESIVES FOR OXYMETRY SENSOR (consumables exclusive for incubator RWT PLUS) To use the oximetry sensor two different types of disposable fixing adhesives are available providing comfort and correct positioning of the patient sensor. Adhesives are supplied in kits with 25 units in two patterns for newborns of different weights: Description Adhesives kit for oxymetry sensor size 1 Adhesives kit for oxymetry sensor size 2

Figure 48 - Adhesive size 1

Olidef code 1600 000030 1600 000035

Figure 49 - Adhesive size 2

Note: It is recommended the use of adhesives size 1 for patients up to 2 kg and adhesives size 2 for patients between 2 and 10 kg.

Note: - Optional item.

1.5.27 - ADHESIVES FOR NB SENSOR (consumables exclusive for incubator RWT PLUS) This adhesives must be used for fixing the temperature sensor on the patient's skin and are supplied in kits of 10 units

Note: - Optional item.

1.6. TECHNICAL SPECIFICATIONS Note: - The Olidef has a policy of continuous improvement of its products and reserves the right to change technical specifications without notice. Rate according to ANVISA Technical name Trade name Trade Model Framework class ANVISA Registration Technical Manager Ratings and Features of Equipment Isolation Class Applied Part Protection Against Water Penetration Operating Mode Protection Against Explosive Atmospheres Mattress Mechanical stability CO2 concentration Air speed on the mattress Inner noise in the Dome (environment 95% in UT) per 0.5 cycle

< 5% UT (break > 95% in UT) per 0.5 cycle

40% UT (break 60% in UT) per 5 cycles

40% UT (break 60% in UT) per 5 cycles

70% UT (break 30% in UT) per 25 cycles

70% UT (break 30% in UT) per 25 cycles

< 5% UT (break > 95% in UT) per 5 s

< 5% UT (break > 95% in UT) per 5 s

0.3 A/m

0.3 A/m

IEC 61000-4-11

Magnetic field generated by the mains frequency (50/60 Hz) IEC 61000-4-8

be wood, concrete or ceramic. If floors are covered with synthetic material, the relative humidity should be at least 30%. It is important that quality of the mains supply be typical of a commercial or hospital environment. It is important that quality of the mains supply be typical of a commercial or hospital environment. It is important that quality of the mains supply be typical of a commercial or hospital environment. If the user needs

the Incubator continued operation during interruptions of mains supply, it is recommended that the incubator is powered by an uninterrupted source or battery.

If distortion occurs, it may be necessary to position the incubator further of magnetic field sources in the mains frequency of power supply or install a magnetic shield. It is important that the magnetic field in the mains frequency of power supply be measured in the site for installation to ensure that it is sufficiently low.

NOTE - UT is the a.c. mains voltage prior to application of the test level.

5 - USE WITH OTHER EQUIPMENT The Transport Incubator RWT PLUS can be used with other equipment, such as: lung fan, oximeter, oxygen monitor, multiparameter monitor, infusion pump, radiometer, phototherapy and x-ray device. Equipment weighing up to 10 kg can be placed directly on the support for monitors. Do not transport the incubator with any type of equipment or packed load in the support for monitors. Such equipment must be positioned securely to prevent fall or accidental displacement when using the incubator. Use the existing straps to lock the equipment. To use the sensors, use the cable passages located on the side of the incubator. To use tubes for lung ventilation, use the passage on the left side of the dome. This device allows the passage of tubes up to 2 inches without loss of heat inside the newborn compartment. CAUTION - The equipment used with the Transport Incubator RWT PLUS must have CE certification and meet the existing harmonized standards for electromagnetic compatibility and electrical safety. The equipment that does not meet these requirements will be subject to receive or to issue an electromagnetic interference and may cause change of reading parameters of failure in heating control and starting of security alarms, and also increase the possibility of electrical failures.

- 35 -

6 - INSTALLATION AND MAINTENANCE 6.1 - INSTALLATION OF EQUIPMENT 6.1.1 - UNPACKING When you receive your RWT PLUS incubator should have the following cares: • Make sure the box containing the equipment shows the impact or perforation signs, then the report should be subject to immediate claim with the carrier, and is recommended to call an authorized representative for joint assessment of any damage caused to the equipment; • However, regardless the presence or absence of external signals (on the package), if found any irregularities occurred during transportation, the procedure should be the same as mentioned in the previous item; • Before using the equipment, fill out the warranty certificate that accompanies it, and send it to Olidef. • Making it necessary to store the equipment, it shall be provided a place where the environmental conditions are suitable, the temperature should not exceed 55ºC and the relative humidity should be below 90% noncondensing. It is recommended that the unit be stored in its original package.

6.1.2 - PRELIMINARY CHECKING After unpacking your RWT PLUS incubator, do the following checks: • General mechanical state of the equipment • General conditions of painting • General state of acrylic dome • Operation of port for intensive care and portholes. • Check of accessories coming with the device (1 AC power cable, 1 set of filters (with 2 units), wrench, regulator valve, double outlet, hose, NB sensor, user guide, 2 fuses and optional requested) as well as the inclusion of the Authorized Agents Ratio to provide technical assistance to this equipment and the Warranty Certificate.

6.1.3 - ASSEMBLY OF EQUIPMENT The Transport Incubator - model SWT PLUS leaves the manufacturer in special packages. Installation Procedures: 1. Place the Incubator holder on a flat surface. Lock the four casters of transport holder. 2. Place the incubator (1) on the holder (2) as shown in Figure 50. Note: - The side door of the dome should be opposite to the height latch of the holder. If the incubator has optional gurney, set the same way with the side door of the dome opposite to the height latch of the gurney as shown in figure 51.

Figure 50 - Assembly scheme

Figure 51 - Assembly scheme

CAUTION - Gas under pressure. Handle carefully.

- 36 -

3. Attach the incubator to the holder through 4 wing nuts that come with the product as shown in Figure 52 and 53 (gurney).

Figure 52 - Incubator attachment to the holder

Figure 53 - Incubator attachment to the gurney

CAUTION - The incubator should be perfectly attached to the holder; failure in this fixation may result in the separation and fall of the incubator holder, especially on bent surfaces and particularly with the dome open. 4. Mount the serum holder shaft in the shaft guide located in the rear. Tight the mandrel to hold the external the shaft as shown in figure 54 and 55 (gurney).

Figure 54 - Attachment of serum shaft

Figure 55 - Attachment of serum shaft

CAUTION - During transport and handling of the Incubator with its serum holder mounted, take precautions to prevent accidents and mechanical shocks. 5. Connect the AC power cable (supplied with the equipment) in the plug of the incubator current input panel. 6. Connect the power cable into a 3-way hospital outlet with supply voltage of 120-230V~. CAUTION - Do not connect the incubator if the hospital outlet does not have a reliable grounding. Check if the voltage and the mains current where the Incubator is being connected correspond to the specifications on the nameplate of the equipment (located on the rear next to the air filter). 7. Turn on the main key on the back of the incubator current input panel. CAUTION - Before using the transport incubator, it is recommended that the battery is charged for a period of 24 hours. 8. To use the equipment with external power of 12V, connect the cable to the external voltage 12V (supplied with the equipment) on the outlet of the current input panel. Connect the cable plug into a cigarette lighter plug in the vehicle that has a voltage of 12V and minimum current of 20A.

- 37 -

CAUTION - For the perfect operation of the incubator, check if the current supplied by the vehicle battery is sufficient to power the device. If the voltage polarity is reversed, this will be indicated by the reversed polarity message on the display. 9. Remove the NB sensor from the packaging. Connect it in the sensor module panel located on the left side of the incubator and then pass the sensor by the tube passages supporting it on the mattress. CAUTION - If the incubator comes with an oxygen servo control system, the NB sensor must be connected to the sensor module inside the NB compartment. - For coupling the Transport Incubator RWT PLUS into ambulances, you should stand down the carriage and engage it in place on the transport means. The right attachment to transport means depends on the conditions and procedures adopted by the customer. Always remember to lock the casters.

6.1.4 - INSTALLING THE CYLINDERS - To install the cylinders in the incubator, slide and position them on the holders for cylinders. - Lock the cylinders in the holders with clamps (A) as shown in figure 56.

Figure 56 - Installation of cylinders

- Fix the control valve (1) to the cylinder (4) to tighten safely and use the wrench provided with the equipment as Figure 57. - Add the flowmeter (2) provided with the equipment as shown in figure 57. - Connect the hose (3) to the flowmeter as shown in figure 57.

Figure 57 - Installation of the regulator valve , flowmeter and hose

- 38 -

Figure 58 - Installation of cylinder (4) control valve (1) , flowmeter (2) and hoses (3) in the dual outlet (5)

Note: - If you choose to use the oxygen servo controlled system, it will not be necessary to use the flowmeter CAUTION - Handle the cylinder carefully so it does not suffer shocks. - There may be danger if the gas gets out quickly from the valve.

6.1.5 - INSTALLING THE INTEGRATED OXIMETRY SYSTEM (OPTIONAL) The integrated oxymetry system comes installed from the manufacturer, and the user needs only to connect the sensor cable on the side panel as shown in figure 59.

Figure 59 - Installation of integrated oxymetry sensor

Note: If there is need to extend the length of the sensor cable, OLIDEF provides an extension cable for pulse oxymetry.

- 39 -

6.1.6 - INSTALLATION OF NEBULIZER (OPTIONAL) In order to use it, put distilled water in the tank (300 ml maximum), fit the nebulizer in the coupler located at the dome and connect it to the mains or compressed air cylinder available. The nebulizer will immediately begin the production of a foam with small particles of water.

Figure 60 - Nebulizer coupled in the dome

6.1.7 - INSTALLING THE GURNEY IN A VEHICLE (OPTIONAL) - Position the stretcher into the vehicle at the site to be installed. Observe if the stretcher has no obstruction in the vehicle entrance and exit.

Figure 61 - Gurney in the ambulance

- Fit the guide into the aerial axis of the stretcher to mark the drilling. - Set the tab stops to a minimum distance of 80 mm between the tab stop and the guide as shown in Figure 62.

Figure 62 - Distance of latches

Figure 63 - Side view

- Fix the screws holding the tab stops and the guide in the ambulance floor. CAUTION - Check the location of holes to avoid damaging the ambulance.

- 40 -

- To install the turtle latch take the gurney back to the tab stop, and then attach the turtle latch in the coupling pin, which is located at the bottom of the gurney (Figure 65) to mark the exact distance between the turtle latch and the tab stops. After checking the drilling, attach the turtle latch rail on the ambulance floor.

Figure 64 - Side view

Figure 65 - Location of the king pin

CAUTION - Before drilling, make sure the floor underneath is free to continue operation, preventing damage to the vehicle. - After fixed the turtle latch, it is necessary to make the adjustment. Set the desired position by moving the turtle latch enough to get the stretcher on the locking tab and the stretcher pin fix it in the turtle latch as indicated by the arrows below. - The screw must be tightened with a torque of 13N.m using a calibrated torque wrench with a key No. 17.

Figure 66 - Turtle latch

- To set the stop latch first assemble the tab stop putting two nuts and the screw. Then, plug the holes in the floor as shown in figure 67.

Figure 67 - Nuts and screw

- 41 -

- Fix the tab stops and guide in the floor as shown in figure 68.

Figure 68 - Fixation of floor

- Make the height adjustment of the tab stop tightening the central nuts of the screw. Fix the locknut to maintain the adjustment as Figure 69.

Figure 69 - Setting of tab stop

- To regulate the turtle latch, set the height of the king pin as the turtle latch. Loose the center nut (2) and set the top nut (1) according to the desired height as shown in figure 70.

Figure 70 - Height adjustment of the king pin

- To regulate the aerial axis, it is important that the casters of the aerial axis should be leveled with the ambulance floor. Before you begin the gurney installation, check if the measurement from the ground to the ambulance floor is equal to the measurement from the ground to the wheel of the gurney aerial axis as Figure 71.

Figure 71 - Checking of ambulance floor level l

- 42 -

- To set , remove the axle screws, figure 72. - Set the axis height according to the ambulance floor level choosing one of the three heights defined and, then, tight the screws again.

Figure 72 - Setting of the casters' height

CAUTION - Keep the upper wheels always leveled with the ambulance floor. - To retract the gurney, pull over the carriage on the ambulance bumper. Make sure the aerial axis wheels are on the floor of the vehicle as shown in figure 73.

Figure 73 - Putting the gurney in the ambulance

CAUTION - Do not operate the retraction handle during transport of patients. The legs' retraction should only be used to put the gurney in the ambulance. - Pull the retraction handle (A) and push the gurney into the vehicle as shown in figure 74. - The safety lock is released when the retraction lever is activated.

Figure 74 - Location of the retraction handle

- 43 -

To remove the gurney from the vehicle: 1. Release the turtle latch pin. 2. Slide the gurney out of the vehicle 3. Before completely remove the gurney from the vehicle (aerial axis on the floor), make sure the bottom of the frame structure (knees) had occur. 4. Remove completely the gurney from the vehicle and proceed the transport.

6.2 - TURNING ON THE TRANSPORT INCUBATOR - model RWT PLUS


Use in Mains

- Connect the power cable from the Transport Incubator into an outlet compatible with the voltage specified on the equipment. CAUTION - The RWT PLUS incubator has AUTOMATIC VOLTAGE SELECTION, the equipment can be connected to mains of 120V ~ 230V ~ . An electronic circuit will automatically select the transformer and power elements preventing burning of its components. - Turn on the main key on the incubator current input panel. - Press the ON key located on the control panel.

•

Setting

The RWT PLUS Transport Incubator has features that allow adjustment of time and date and record the patient's name (To set time and date, see item 6.3.2 - DATE/TIME) (To record the patient's name, see item 6.3.3 - Record of patient's data)

6.2.1 - USE OF AR MODE AR control mode provides a stable control of the air temperature in the newborn compartment through the automatic activation of heating resistance as desired temperature programmed by the operator. In this operation mode, the incubator has HOT and COLD AIR alarms which will be activated when the temperature is checked for AR with a difference greater than 1.0ºC related to the desired temperature. The desired value for the air temperature can be set within the range of 20 to 37°C in increments of 0.1°C. The actual value and the desired value will be indicated on the control panel. How to use the AR mode: - Check if the sensor modules are connected. - Turn on the transport incubator - model RWT PLUS - The equipment comes with set point manufacturer programmed to 34.5°C. Whenever the equipment is turned off, the value programmed restarting the AR operation mode will be manufacturer-programmed. - To set the desired value for the AIR temperature, press AIR in the display or press the knob and scroll all fields to AIR and press it. - To set a value , use the virtual keys to increase or decrease the parameters or turn the knob to the desired value for the AIR temperature into the newborn compartment. To confirm, press the knob or wait for any further changes.

Figure 75 - Set point of AIR temperature

- 44 -

The RWT PLUS Transport Incubator allows the operator to program temperatures above 37ºC. To program higher values (above 37ºC): - Press "> 37ºC" to enable a set point between 37.1ºC to 39ºC , the LED will indicate as shown in figure 76.

Figure 76 - LED indicator "> 37ºC" key activated

- To set the desired value, press AIR in the display or press the knob and scroll all fields to AIR and press it. - To set the value above 37ºC , use the virtual increase keys of parameters or turn the knob, as with the ">37ºC" key pressed this is possible. To confirm, press the knob or set with no further changes.

Figure 77 - Set point of AIR temperature above 37ºC

Notes: - Within the AIR field, the greater number (to the right) shown is the current read value. The smaller number (to the left) represents the programmed value (set point). - The incubator will automatically control the power of the heating resistance to stabilize the incubator temperature as the programmed temperature set by the user. - To the right of the read value to the AIR temperature is a proportional indication bar of the heating level as shown in Figure 77. - The low temperature alarm will be inhibited for 40 minutes after the equipment come into operation mode. The alarm is automatically uninhibited after this time.

6.2.1 - USE OF NB MODE In the NB mode, the incubator provides the heat necessary for the patient to stabilize his/her body temperature through automatic activation of the heater according to the value set by the operator. In this operation mode, the incubator has HYPERTHERMIA and HYPOTHERMIA alarms which will be activated when the temperature is checked for nb with a difference greater than 1.0ºC related to the desired temperature. The desired value for the NB temperature can be set within the range of 30 to 37°C in increments of 0.1°C. The actual value and the desired value will be indicated on the control panel. How to use the NB mode: - Check if the sensor module and the NB sensor are connected.

- 45 -

- Wash carefully and dry the patient's skin where the sensor will be fixed (on the abdomen or back, if the child is lying on the stomach). - Place the sensor on the abdominal skin of the patient and secure it using a non-allergenic adhesive as shown in Figure 78.

A. Adhesive for temperature sensor B. NB sensor C. NB skin

Figure 78 - Scheme for fixing the NB sensor

- Turn on the transport incubator - model RWT PLUS - To set the desired value for the NB temperature, press NB in the display or press the knob and scroll all fields to NB and press it. - The equipment comes with set point manufacturer programmed to 36.0°C. Whenever the equipment is turned off, the value programmed restarting the NB operation mode will be manufacturer-programmed. - To set a value, use the virtual keys to increase or decrease the parameters or turn the knob to the desired value for the NB temperature into the newborn compartment. To confirm, press the knob or wait for any further changes.

Figure 79 - Set point of NB temperature

The RWT PLUS Transport Incubator allows the operator to program temperatures above 37º C. To program higher values (above 37ºC): - Press "> 37ºC" to enable a set point between 37.1ºC to 38ºC, the LED will indicate as shown in figure 80.

Figure 80 - LED indicator "> 37ºC" key activated

- 46 -

- To adjust the desired value, press NB in the display or press the knob and scroll all fields to NB and press it. - To set the value above 37ºC, use the virtual increase keys of parameters or turn the knob, as with the ">37ºC" key pressed this is possible. To confirm, press the knob or set with no further changes.

Figure 81 - Set point of NB temperature above 37ºC

Notes: - Within the NB field, the greater number (to the right) shown is the current read value. The smaller number (to the left) represents the programmed value. - The incubator will automatically control the power of the heating resistance to stabilize the NB temperature as the programmed temperature set by the user. - To the right of the read value to the NB temperature there is a proportional indication bar of the heating level as shown in Figure 81. - The NB weight, age, medical condition, and other metabolic and environmental factors will affect the time required for temperature stabilization of the patient in relation to temperature. CAUTION - The skin sensor should never be used to control rectal temperature because the patient could receive insufficient or excessive heat. - RWT PLUS Transport Incubator cannot measure or monitor the skin temperature of the patient if the NB sensor is not correctly placed on the patient. The disconnection or failure in the direct sensor contact with the patient's skin will cause an incorrect reading of temperature, and the incubator cannot regulate the necessary heat for the patient. - Use temperature sensors provided only by OLIDEF or its authorized representatives. The use of different specified sensors may cause errors in the temperature reading and therefore risks to the patient.

6.2.3- HUMIDITY CONTROL The RWT PLUS transport incubator can manage the humidity in two different ways in the NB compartment. •

Passive relative humidity

•

Servo control of air relative humidity




Passive relative humidity of air

1. Unlock and open the front and side access doors 2. Pull the bed out of the dome by the end of its course 3. Wet the sponge "A" (Figure 82) located under the bed mattress slowly pouring 450 ml of distilled or sterile water, using a dosage cup. This amount of water will be sufficient for a period longer than 12 hours of use

- 47 -

4. Replace the bed into its original position and close the access doors

Figure 82 - Location of humidification foam

CAUTION - The humidity level inside the incubator will depend on the relative humidity of the environment air. - When the air temperature inside the incubator is relatively higher than the air temperature, a condensation may form on the inner walls of the dome. When the difference between the temperatures is lower, condensation will not appear.




Servo control of relative air humidity (Optional Module)

In the servo controlled mode, the incubator provides a stable control of air humidity in the newborn compartment through the automatic activation of the piezoelectric pellet according to the value set by the operator. In this operation mode, the incubator has HIGH HUMIDITY and LOW HUMIDITY alarms which will be activated when the humidity is checked for the compartment with a difference greater than 15% related to the desired humidity. This servo controlled system allows the incubator operator to monitor and adjust the relative humidity inside the newborn compartment. The desired value for the relative humidity can be set within the range of 20 to 95% in increments of 1%. The actual value and the desired value of air relative humidity will be indicated on the control panel. Filling the water tank: 1- Unlock the water drawer by pulling the latch (A) to the front as shown in figure 83.

Figure 83 - Location of water drawer latch

- 48 -

2- Pull out carefully and remove the tank cover. 3- Fill or replace the water tank to the level indicated as shown in figure 84.

Figure 84 - Filling of water tank

Note: - The tank maximum capacity is 1L. CAUTION - Use distilled or deionized water only. 4 - Replace the tank cover. 5 - Push the drawer to its original position to realize that the same locked into the right position. Setting the air relative humidity inside the dome: -

-

To adjust the desired value for relative humidity, press UR in the display or press the knob and scroll all fields to UR and press it. To set a value, use the virtual keys to increase or decrease the parameters or turn the knob to the desired value for the air relative humidity into the newborn compartment. To confirm, press the knob or wait for any further changes. After finishing the program, the servo controlled humidification system of the RWT PLUS incubator will start the process until the relative humidity reaches the predetermined value set by the operator, keeping thehumidity next to the programmed value.

Figure 85 - Graphic display - humidity control

Notes: -

-

Within the UR field, the greater number (to the right) shown is the current read value. The smaller number (to the left) represents the programmed value. The use of servo controlled humidification system is optional. To disable the system, program the desired humidity to a value lower than the read value. The display will continue showing the air relative humidity inside the dome and the desired value will be deleted. When the servo controlled humidification system is turned off, the initial value indicated for relative humidity will start at 1% above the read value. Whenever the tank has low water level, the servo controlled humidification system will remain off and an alarm will sound. - 49 -

6.2.4 - OXYGEN CONTROL The RWT PLUS Transport Incubator may administer oxygen in three different ways, but it will be manufacturerdelivered in 2-way only. •

limiting oxygen valve (inlet to limited 8Lpm)

•

passive oxygen valve (inlet to limited 32Lpm)

•

oxygen servo control (optional - inlet limited to 32Lpm).

Note: - The limiting oxygen valve and the passive oxygen valve are line items; if the customer chooses the passive oxygen valve or the servo control of oxygen, the composition of equipment will be as follows: -

limiting oxygen valve; Oxygen servo control. CAUTION -Read and understand the warnings contained in item 3 – Warnings and/or precautions to be taken adopted in this guide. -The air inside the newborn compartment should be enriched only with oxygen under prescription.


-

Operating Mode of Limiting Oxygen Valve

Turn on the incubator and wait for the stabilization of the inner temperature. If the incubator has to manage humidification with oxygen application, wait so the air humidity inside the compartment is stabilized. Through a pressure hose with braided nylon 250 PSI nontoxic, connect the flow meter output of mains or a hospital oxygen cylinder to the oxygen input valve nipple from the incubator as Figure 86.

Figure 86 - Connection for operation of limiting oxygen valve

-

-

Install an oxygen monitor, placing the sensor near to the center of the newborn compartment. Start the oxygen supply after turning the incubator only to ensure proper mixing of gases within the dome Determine the initial flow of oxygen based on the table located above aside of the relief valve, located on the right side of the incubator. This table shows approximate values for the oxygen flow required to maintain the desired concentration. The concentration obtained may vary depending on the relative air humidity inside the compartment, the state of the air filter, seals of dome, number and frequency of portholes opening. Wait 15 minutes and check the oxygen concentration inside the incubator indicated by O2 monitor without opening the dome. If necessary, set the oxygen flow through the mains flow meter or cylinders. Repeat O2 concentration reading every 15 minutes.

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Note: - Flows of oxygen above 15 liters per minute will produce oxygen concentrations above the values indicated in the table.

Input Flow (L/min)

0

2

4

6

8

10

12

15

O2 Concentration (%)

21

26 – 36

44 – 54

48 – 58

65 – 75

66 – 76

75 – 85

80 - 90

CAUTION - Oxygen therapy may raise the noise level for the NB inside the incubator. - The flow of oxygen cannot be used as an accurate measurement of oxygen concentration inside the incubator, oxygen concentrations should be measured with a duly calibrated oxygen analyzer. - Improper use of supplemental oxygen may be associated to serious side effects including blindness, brain cell damage and death. The risk varies with each patient. The method, concentration and duration of oxygen administration should be prescribed by a physician skilled about risks and benefits. - If you need to administer oxygen in an emergency, the attending physician should be notified immediately. - Oxygen therapy should be done under the supervision of qualified medical personnel only. - The oxygen concentration inhaled by a child does not determine in advance the partial oxygen pressure in the blood. - Opening of access door may cause a drop in the oxygen concentration. To make a new measurement, wait a few moments to restore the concentration. - Do not use oxygen in the presence of flammable anesthetics. - Keep all ignition sources (e.g., matches, cigarettes, devices that produce sparks, etc..) away from the room where the incubator is operating. Fabrics, oil or other fuel ignites easily when the air is enriched with oxygen.


-

Operating Mode of Passive Oxygen Valve.

Turn on the incubator and wait for the stabilization of the inner temperature. If the incubator has to manage humidification with oxygen application, wait so the air humidity inside the compartment is stabilized. Through a pressure hose with braided nylon 250 PSI nontoxic, connect the flow meter output of mains or a hospital oxygen cylinder to the oxygen input valve nipple from the incubator as Figure 87.

Figure 87 - Connection for operation of passive oxygen valve

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-

-

Install an oxygen monitor, placing the sensor near to the center of the newborn compartment. Start the oxygen supply after turning the incubator only to ensure proper mixing of gases within the dome Determine the initial flow of oxygen based on the table located above aside of the relief valve, located on the right side of the incubator. This table shows approximate values for the oxygen flow required to maintain the desired concentration. The concentration obtained may vary depending on the relative air humidity inside the compartment, the state of the air filter, seals of dome, number and frequency of portholes opening. Wait 15 minutes and check the oxygen concentration inside the incubator indicated by O2 monitor without opening the dome. If necessary, set the oxygen flow through the mains flow meter or cylinders. Repeat O2 concentration reading every 15 minutes.

Note: - Flows of oxygen above 15 liters per minute will produce oxygen concentrations above the values indicated in the table.

Input Flow (L/min)

0

2

4

6

8

10

12

15

O2 Concentration (%)

21

26 – 36

44 – 54

48 – 58

65 – 75

66 – 76

75 – 85

80 - 90

CAUTION - Oxygen therapy may raise the noise level for the NB inside the incubator. - The flow of oxygen cannot be used as an accurate measurement of oxygen concentration inside the incubator, oxygen concentrations should be measured with a duly calibrated oxygen analyzer. - Improper use of supplemental oxygen may be associated to serious side effects including blindness, brain cell damage and death. The risk varies with each patient. The method, concentration and duration of oxygen administration should be prescribed by a physician skilled about risks and benefits. - If you need to administer oxygen in an emergency, the attending physician should be notified immediately. - Oxygen therapy should be done under the supervision of qualified medical personnel only. - The oxygen concentration inhaled by a child does not determine in advance the partial oxygen pressure in the blood. - Opening of access door may cause a drop in the oxygen concentration. To make a new measurement, wait a few moments to restore the concentration. - Do not use oxygen in the presence of flammable anesthetics. - Keep all ignition sources (e.g., matches, cigarettes, devices that produce sparks, etc..) away from the room where the incubator is operating. Fabrics, oil or other fuel ignites easily when the air is enriched with oxygen.




Oxygen Servo Control (Optional Module)

In the servo controlled mode, the incubator provides a stable control of oxygen in the newborn compartment through the automatic activation of the solenoid valve according to the value set by the operator. In this operation mode, the incubator has HIGH O2 LEVEL and LOW O2 LEVEL alarms which will be activated when the oxygen is checked for the compartment with a difference greater than 3% related to the desired oxygen. The desired value for the oxygen concentration can be set within the range of 21 to 65% in increments of 1%. The actual value and the desired value of oxygen concentration shall be indicated in the display. How to use the oxygen mode: -

Turn on the incubator and wait for the stabilization of the inner temperature. If the incubator has to manage humidification with oxygen application, wait so the air humidity inside the compartment is stabilized. Through a pressure hose with braided nylon 250 PSI nontoxic, connect the output of the vehicle or a hospital oxygen cylinder to the oxygen input valve nipple from the incubator as Figure 88.

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Figure 88 - Connection for operation of oxygen servo control valve

-

-

Calibrate the oxygen sensors as item "calibration of oxygen sensors" page 89. To adjust the desired value for oxygen, press O2 in the display or press the knob and scroll all fields to O2 and press it. To set a value, use the virtual keys to increase or decrease the parameters or turn the knob to the desired value for the oxygen desired value into the air inside the newborn compartment. To confirm, press the knob or wait for any further changes. After finishing the programming, the oxygen servo controlled system of the RWT PLUS incubator will start the process until the oxygen reaches the predetermined value set by the operator, keeping the oxygen next to the programmed value.

Figure 89 - Graphic display of the oxygen control system

Notes: -

-

Within the O2 field, the greater number (to the right) shown is the current read value. The smaller number (to the left) represents the programmed value. The use of the oxygen servo controlled system is optional. To disable the system, program the oxygen to a value lower than the read value. The display will continue showing the oxygen concentration inside the dome and the desired value will be deleted. When the oxygen servo controlled system is turned off, the initial value indicated for oxygen will start at 1% above the read value. For the servo controlled oxygen system to function properly, calibrate the oxygen sensors at intervals of no more than 10 days or every time the incubator is turned on.

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CAUTION - It is recommended a daily calibration to maintain accurate system. - Oxygen therapy may raise the noise level for the NB inside the incubator. -Monitor with an Oxygen Analyzer properly calibrated at O2 concentration in the NB compartment and compare with the value indicated on the incubator display. - Improper use of supplemental oxygen may be associated to serious side effects including blindness, brain cell damage and death. The risk varies with each patient. The method, concentration and duration of oxygen administration should be prescribed by a physician skilled about risks and benefits. - If you need to administer oxygen in an emergency, the attending physician should be notified immediately. - Oxygen therapy should be done under the supervision of qualified medical personnel only. - The oxygen concentration inhaled by a child does not determine in advance the partial oxygen pressure in the blood. - Opening of access door may cause a drop in the oxygen concentration. To make a new measurement, wait a few moments to restore the concentration. - Do not use oxygen in the presence of flammable anesthetics. - Keep all ignition sources (e.g., matches, cigarettes, devices that produce sparks, etc..) away from the room where the incubator is operating. Fabrics, oil or other fuel ignites easily when the air is enriched with oxygen.

Calibration of oxygen sensors: This procedure is fast (less than 60 seconds) and is essential for the correct operation of the equipment. To calibrate the equipment, follow the following procedure: Pull the drawer latch and the sensor module until the course end as Figure 90.

Figure 90 - Calibration of oxygen sensors

- The equipment will sound an alarm and the graph display will show the following message: "Calibrating” - After a period of approximately 30 seconds, another alarm will sound and the following message appears on the display: “Completed". - Return the sensor module to its position within the incubator. The calibration of oxygen sensors is completed.

Note: - To perform this calibration procedure, make sure that the room where the incubator is installed shows normal concentration of oxygen (21%).

6.2.5 OXYMETRY OF INTEGRATED PULSE (OPTIONAL MODULE) The oxymetry system of integrated pulse allows the heart rate (BPM), the rate of saturated hemoglobin with oxygen in the blood (SPO2) and the plethysmographic curve are monitored in the graphic display of control panel. The system also has programmable security alarms for monitored parameters. How to use the sensors: - Turn on the incubator and wait for the stabilization of the inner temperature. - Check if the sensor is connected to the side panel and to the NB.

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- There are two types of sensors and adhesives available for oxymetry. The use of each type of sensor and adhesive for fixation will depend on the size of patients, as shown below: Patients up to 2Kg Sensor 1 \ Adhesive 1

Patients between 2-10 kg Sensor 2 \ Adhesive 2

PROCEDURE FOR PLACEMENT OF SENSORS

SENSOR 1

SENSOR 2

- Remove the adhesive protector of the fixation sensor.

- Fix the adhesive in the oxymetry sensor.

- Place the sensor on the patient skin surface (finger or foot).

- The side of the sensor containing the light emitting should be on the top side of the foot or on the side of finger nail; the detector must be in the opposite side. By placing the sensor on the patient, try to let the receiver and detector aligned to ensure the best possible signal for the system. - Fix the adhesive in the sensor, rolling it over the foot or finger skin of the patient, taking care not to obstruct blood flow.

- To ensure a good result in the sign reading, attach the sensor cable (regardless adhesive sensor) with a ribbon, as shown in the figure. Be careful one more time not to obstruct the blood flow.

Note: - If the sensor is not positioned correctly, the oxymetry system may not function properly. - The proper placement of the oxymetry sensor is essential for the system operation. Follow carefully the indicated guidelines. CAUTION - Do not use oxymetry sensors that are not provided directly by OLIDEF or its authorized representatives. - Discontinue the use of the oxymetry sensor if the fixation adhesive causes allergic reactions to the patient. - Do not use damaged oxymetry sensors. - The oxymetry sensors should not be immersed in water or any kind of solution. - Do not use abrasive or corrosive products to clean the sensors.

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Heart Rate (BPM)

In monitoring mode, the incubator has HIGH FREQUENCY OF HEART RATE and LOW FREQUENCY OF HEART RATE alarms that will be activated when the heart rate reaches the programmed limits. The monitoring rate will be from 0 to 250 bpm, and the activation limits of the alarms can be set within a range of 0 to 250bpm in increments of 1bpm. The reading value and limits set will be indicated on the control panel. How to set limits: - The equipment comes with alarm limits for heart rate set at 50 and 200 bpm. Whenever the equipment is turned off, the programmed value restarting the monitoring mode will be manufacturer-programmed. - To adjust the maximum limit, press BPM in the display or press the knob and scroll all fields to BPM and press it. To set a maximum value, use the virtual keys to increase or decrease the parameters or turn the knob to the desired value. To confirm, press the knob. - To set a minimum value, use the virtual keys to increase or decrease the parameters or turn the knob to the desired value. To confirm, press the knob.

Figure 91 - Graphic Display - Heart rate BPM

Notes: - Within the BPM field, the greater number (to the right) shown is the current read value. Smaller numbers (to the left) represent the maximum and minimum alarms. - The maximum or minimum values within the "MAX BPM" limit will be directly related to the maximum and minimum "MIN BPM" limit. - The use of oxymetry is optional. To turn off the system, disconnect the sensor from the sensors’ module in the incubator and silence the alarm. - Pulse rate below 20 (except zero) will be displayed as 20 and above 250 will be displayed as 250. A pulse frequency zero is used to indicate that the monitor is not monitoring the pulse.




SPO2

In this monitoring mode, the incubator has alarms of HIGH SPO2 % and LOW SPO2 %, which will be activated whenever the rate of hemoglobin saturated with oxygen in the blood reaches the programmed limits. The monitoring rate will go from 0 to 100%, and the activation limits of the alarms can be set within a range of 0 to 100% in increments of 1%. The reading value and adjusted limits will be indicated on the control panel. How to set limits: - The equipment comes with alarm limits for SPO2 set at 90% and 100%. Whenever the equipment is turned off, the programmed value restarting the monitoring mode will be manufacturer-programmed. - To adjust the maximum limit, press SPO2 in the display or press the knob and scroll all fields to SPO2 and press it. To set a maximum value, use the virtual keys to increase or decrease the parameters or turn the knob to the desired value. To confirm, press the knob. - To set a minimum value, use the virtual keys to increase or decrease the parameters or turn the knob to the desired value. To confirm, press the knob.

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Figura 92 - Display gráfico - PLET

Notes: - Within the SPO2 field, the greater number (to the right) shown is the current read value. Smaller numbers (to the left) represent the maximum and minimum alarms. - The maximum or minimum values within the "HIGH SpO2" limit will be directly related to the maximum and minimum "LOW SpO2" limit during the adjustment. - The use of oxymetry is optional. To turn off the system, disconnect the sensor from the sensors’ module in the incubator and silence the alarm.


-

Plethysmographic Curve

To view the plethysmographic curve, press PLET tab in the display or press the knob and scrolls all fields to PLET tab and press it.

Figure 93 - Graphic Display - Plethysmographic Curve

6..2.6 - TREND GRAPHICS The RWT PLUS Transport Incubator has a view system of parameters through Trend Graphic; these graphics are located in the right bottom of the display. The parameters that can be viewed in Trend Graphs are:


AIR Temperature;




NB Temperature;




Air Relative Humidity (optional);




Oxygen (optional);




Simultaneous

For all parameters the trend monitoring time is the last 7 hours. The graphs are presented with the desired parameter on the ordinate axis and the time in hours on the abscissa axis - 57 -




AIR Temperature Trend

To view the trend graphic for air temperature, press the AIR tab in the display or scroll all fields to AIR and press it. The graphic display will present a graphic where air temperature can be analyzed over time:

Figure 94 - Trend Graphic for AIR temperature




NB Temperature Trend

To view the trend graphic for NB temperature, press the NB tab in the display or scroll all fields to NB and press it. The graphic display will present a graphic where NB temperature can be analyzed over time:

Figure 95 - Trend Graphic for NB temperature




Humidity Trend

To view the concentration trend of air humidity inside the newborn compartment, press the UR tab in the display or press the knob and scroll all fields to UR tab and press it. The graphic display will present a graphic where UR concentration can be analyzed over time:

Figure 96 - Trend Graphic for UR concentration

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Oxygen Trend

To view the concentration trend of oxygen concentration, press the O2 tab in the display or press the knob and scroll all fields to O2 tab and press it. The graphic display will present a graphic where O2 concentration can be analyzed over time:

Figure 96 - Trend Graphic for O2 concentration




Simultaneous Trend

The control panel has an additional feature that allows the incubator operator to view in one graphic only all trends. To view all trends simultaneously, press the ALL tab in the display or press the knob and scroll all fields to ALL tab and press it.

Figure 98 - Graphic Display - ALL

Note: - It appears graphs of AIR temperature, NB temperature, humidity, oxygen and SpO2 (in blue color).

6.3 - ADDITIONAL RESOURCES 6.3.1 - KEYBOARD LOCK The control panel has an additional feature that allows the incubator operator to lock the keyboard preventing unintentional changes of the parameters previously set. - To lock the keyboard, press “KEYBOARD LOCK” key. The keyboard lock indicator will light on. In this condition, no parameter indicated by the incubator may be changed through the keyboard. - To unlock the keyboard, press “KEYBOARD LOCK” key again. The keyboard lock indicator will light off.

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Figure 99 - Front panel of the incubator

6.3.2 - DATE AND TIME The control panel has an additional resource indicating date and hour as figure 100.

Figure 100 - Graphic display - DATE / TIME

How to set hour and date: - When you turn on the equipment, select DATE / TIME option and press the knob as figure 101.

Figure 101 - DATE / TIME selection

- To choose the parameters to be adjusted press the knob as Figure 102. - To adjust the parameters' value, turn on the knob. - After setting the time and date, press ENTER to save the values and the incubator will enter the STANDBY mode.

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Figure 102 - Graphic display - DATE / TIME

Note: - Keep these adjusted data correctly so trend graphics can show the data correctly. - If you do not wish to set DATE / TIME, select "OK" and press the knob. The equipment will enter the standby mode.

6.3.3 PATIENT REGISTRATION The control panel has an additional feature that allows the registration of the patient'S name. How to register the NB name: - When you turn on the equipment, select PATIENT REGISTRATION option and press the knob as figure 103.

Figure 103 - PATIENT REGISTRATION

- To fill the patient's name, just use the knob to scroll through the characters and to insert it just press the knob and move to the next character as shown in Figure 104. - To end just turn on the knob to the OK field and press the knob or the ENTER key to save the registered name. The incubator will enter the AIR mode of operation automatically.

Figure 104 - Graphic display - patient registration

Notes: -

The equipment operates normally without the patient's name registration. If you do not wish to register the NB, select "OK" and press the knob. The incubator will enter the AIR mode of operation automatically. To erase the desired feature, turn the knob to the DEL field and press it. Thus, the last character will be deleted. If you wish to delete other features, continue pressing the knob on the DEL field. The equipment to be turned off and on again will not show the registered name on the display; if you want to register again proceed the first step in item 6.3.3 - Patient Registration.

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6.3.4. ENVIRONMENT TEMPERATURE The control panel has an additional feature that indicates the environment temperature.

Figure 105 - Graphic display - Environment Temperature

6.3.5 - BATTERY CHARGE The control panel has an additional feature that indicates the remaining battery charge. - Equipment off and no C.A mains If the equipment is connected to the main key on, a screen will appear stating the remaining charge. As figure 106.

Figure 106 - Graphic display - battery charge

- Equipment off and with C.A mains If the equipment is connected to the main key, a screen will appear stating the remaining charge and a symbol that the battery is recharging. As figure 107.

Figure 107 - Graphic display - battery charging

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- Equipment On With equipment on, the information is in the upper right corner. As figure 108.

Figure 108 - Graphic display - battery charge

6.4 - OPERATION OF ALARMS The transport incubator - model RWT PLUS has an alarm system, whose function is to alert the equipment user on the occurrence of a patient's clinical situation out of normal limits on any problems or technical issues of the equipment. In all alarms activated, an intermittent alarm is activated, and a red LED light indicator is activated with a message written on the display. The audio can be muted temporarily but the visual indication will remain until the normal condition be restored. Note: - SILENT ALARM Key - Through the SILENT ALARM key, the user can turn off the tone of some alarms for a period of 15 minutes. In this condition, the alarm will continue to be indicated by a red LED in the panel control and an error message on the display. In case of another alarm activation, even if the alarm is inhibited, the activation will be emitted by the equipment. - If the alarm condition remains beyond 15 minutes, the alarm will be reactivated and the user will be able to inhibit the sound activation for another 15 minutes pressing the SILENT ALARM key again. - Always check the alarms activation cause to ensure the patient’s safety. Note: - Priority of alarm condition: all alarms indicated by the RWT PLUS transport incubator are considered high priority. - Level of sound pressure of alarms: a 3m distance, perpendicular to the front of the incubator and approximately 1.5 m above the floor is at least 65 dB. - Delay time inherent to the determination of the alarm condition: the delay time for the alarm activation is less than 5 seconds. - Delay in the alarm system: the alarm system has time to detection of alarms less than 5 seconds. CAUTION - The alarms that cannot be silenced by SILENT ALARM key: - Alarm of battery failure; - Alarm of air circulation; - Alarm of sensor modules disconnected; - Alarm of sensor modules misplaced; - Alarm of engine failure; - Alarm of system failure; - Alarm of UR sensor failure;

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GENERAL:

1) Alarm of C.A. mains failure This alarm will be activated when the power supply by mains of 120 / 230V ~ is interrupted. In this condition, the incubator will automatically use power from the internal battery of 12V. In addition to the audible alert, there will be a visual indication through a red LED panel and the C.A. MAINS FAILURE message on the display. The sound signal may be inhibited by the SILENT ALARM key, remaining, however, the indication by the red LED. 2) Alarm of discharged battery This alarm indicates a LOW BATTERY message on the display through a red LED located on the control panel and an audible alert that the battery has reached a very low charge after the alarm activation, the Incubator may work for another 10 minutes maintaining its normal functions. After this time, the incubator temperature will get lower to the total darkness of the control module. CAUTION - The use of the Incubator indicating discharged battery or its prolonged stay in this condition may cause irreversible damages to the battery. It is the device operator responsibility the constantly checking of the battery charge level. Defects resulting from improper use or lack of battery maintenance will not be covered by the warranty. 3) Alarm of battery failure This alarm will be activated when a battery failure occurs. In addition to the audible alert, there will be a visual indication through a red LED panel and a BATTERY FAILURE message on the display. The sound alarm will not be showed by the SILENT ALARM key.

Note: - To use the equipment in this condition, the operator must turn off the main key and connect the equipment to a power supply of 120 - 230V~ or auxiliary power of 12V..... activate the main key again and turn the equipment on. In this case, the incubator has a display message informing a battery failure and the indication through a red LED. CAUTION - The use of the Incubator indicating battery failure or its prolonged stay in this condition may cause irreversible damages to the battery. Defects resulting from improper use or lack of battery maintenance will not be covered by the warranty. 4) Alarm of reversed polarity This alarm will be activated when the polarity of the 12V auxiliary supply is reversed. This will make the incubator operates through the battery. In addition to the audible alert, there will be a visual indication through a red LED in the panel and the REVERSED POLARITY message on the display. This alarm can be inhibited by pressing the SILENT ALARM key. 5) Alarm of air circulation This alarm is activated if the engine stops, problem in the fan or reduction of airflow. Whenever the circulation alarm is activated, remove the patient from the incubator because in this condition the air inside the NB compartment is not being renewed. Whenever the air circulation alarm is activated the incubator will automatically turn off all servo control systems. Sudden changes in the temperature inside the incubator dome can cause the alarm activation. If the alarm is activated, the incubator holds on for 10 minutes. If the air circulation returns to normal, the incubator will automatically turn off the alarm; if the alarm persists send the equipment to the nearest service center. In addition to the audible alert, there will be a visual indication through a red LED panel and a CIRCULATION FAILURE message on the display. The sound alarm will not be showed by the SILENT ALARM key. CAUTION - When the incubator is connected, the AIR Circulation Alarm will remain inhibited for 40 minutes. - By presenting risk to the patient this alarm cannot be inhibited by the SILENT ALARM key.

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6) Alarm of sensor modules disconnected This alarm is activated when the sensor module is disconnected from the equipment (by the user or accidentally). In addition to the audible alert, there will be a visual indication through a red LED panel and the SENSOR MODULE DISCONNECTED message on the display. The sound alarm will not be showed by the SILENT ALARM key. CAUTION - The sensor module should remain connected during use of the incubator. 7) Alarm of sensor modules misplaced Indicates that the sensor module of the incubator is out of the correct position for its operation. In addition to the audible alert, there will be a visual indication through a red LED panel and the MISPLACED MODULE message on the display. The sound alarm will not be showed by the SILENT ALARM key. Whenever the sensor module misplaced alarm is activated, the incubator will automatically turn off all servo control systems. 8) Alarm of system failure This alarm is activated when the electronic systems detect the failure of any component or operation routine. In addition to the audible alert, there will be a visual indication through a red LED panel and a SYSTEM FAILURE (CODE) message on the display. The sound alarm will not be showed by the SILENT ALARM key. The (CODE) informed is the failure indication occurred in the system. Whenever the sensor module misplaced alarm is activated, the incubator will automatically turn off all servo control systems. 9) Alarm of engine failure This alarm is activated when the electronic system detects a failure in the engine or electronic whip associated to it. In addition to the audible alert, there will be a visual indication through a red LED panel and a FAILURE OF AIR CIRCULATION ENGINE message on the display. The sound alarm will not be showed by the SILENT ALARM key. Whenever the engine failure alarm is activated, the incubator will automatically turn off all servo control systems.




TEMPERATURE:

10) Alarm of hot air This alarm is activated when the temperature inside the dome has a difference greater than 1.0°C related to the desired programmed temperature (AR mode only). In addition to the audible alert, there will be an indication through a red LED in the panel and the HOT AIR message on the display. The sound alarm will not be showed by the SILENT ALARM key for a period of 15 minutes. By the end of such period, if the hot air condition persists the sound alert is activated again. CAUTION - This alarm activation during the normal use for long periods may show some kind of technical problem. If so, look for an Authorized Service Center. 11) Alarm of cold air This alarm is activated when the temperature inside the dome has a difference greater than 1.0°C lower than the desired programmed temperature (AIR mode only). In addition to the audible alert, there will be an indication through a red LED in the panel and the COLD AIR message on the display. The sound alarm will not be showed by the SILENT ALARM key for a period of 15 minutes. By the end of such period, if the hot air condition persists the sound alert is activated again. CAUTION - This alarm activation during the normal use for long periods may show some kind of technical problem. If so, look for an Authorized Service Center. 12) Alarm of NB Sensor disconnected This alarm is activated when the NB sensor is disconnected from the sensor module (by the user or accidentally) while the incubator is being used in the NB mode. In this condition, the NB display will indicate the temperature and will not work in the NB mode, assuming the AIR mode automatically. This alarm is indicated through a red LED on the control panel, a NB SENSOR FAILURE message and a sound alert To inhibit the alarm press the SILENT ALARM key.

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13) Alarm of NB sensor failure; This alarm is activated when the NB sensor fails operating in the NB mode (component failure, short circuit or open circuit) This alarm is indicated through a red LED on the control panel, a NB SENSOR FAILURE message and a sound alert. To inhibit the alarm press the SILENT ALARM key. 14) Alarm of hyperthermia This alarm will be activated for NB mode only and will be activated whenever the difference between the desired temperature set by the user and the newborn temperature is greater than 1.0°C. In addition to the audible alert, there will be a visual indication through a red LED panel and a HYPERTHERMIA message on the display. The operator can inhibit the alarm for a period of 15 minutes by pressing the SILENT ALARM key. At the end of such period, if the patient’s hyperthermia condition persists, the alarm will be reactivated. 15) Alarm of hypothermia This alarm will be activated in the NB mode only and will be activated whenever the difference between the desired temperature set by the user and the newborn temperature is greater than 1.0°C lower than the desired and programmed temperature. In addition to the sound alert, there will be a visual indication via red LED on the panel and the HYPOTHERMIA message on the display. The operator can inhibit the alarm for a period of 15 minutes by pressing the SILENT ALARM key. At the end of such period, if the patient’s hypothermia condition persists, the alarm will be reactivated. 16) Alarm of overheating For more safety, the electronic circuits and temperature sensor responsible for activation of such alarm are independent of micro processed thermostat. Whenever the overheating alarm is activated the incubator automatically will turn off all servo control systems. This alarm is activated when the temperature inside the dome exceeds 40°C In addition to the audible alert, there will be an indication through a red LED in the panel and the OVERHEATING message on the display. The sound alert only can be inhibited by the SILENT ALARM key; the red LED on the panel and the message on the display will keep indicating the alarm. These indications shall remain until reduction of air temperature lower than 39°C and enabling again the resistance thus keeping it that way. To exit the overheating alarm condition you should press the SILENT ALARM key again. CAUTION - The use of the incubator in environments with high temperature, direct exposure to sunlight, incandescent light, thermal mattresses and phototherapy can cause the alarm activation.




HUMIDITY (OPTIONAL):

17) Alarm of low water level This alarm will be activated whenever the humidification system is on and the water level in the tank is below the minimum level. When the low level alarm is activated, the piezoelectric pellet will be turned off and the servo controlled humidification system will de deactivated. In addition to the audible alert, there will be an indication through a red LED in the panel and the LOW WATER LEVEL message on the display. The sound alarm can be inhibited by the SILENT ALARM key only. 18) Alarm of HIGH humidity This alarm is activated when the relative humidity is indicated on the display with a difference greater than 15% above the desired value programmed by the incubator operator. In addition to the audible alert, there will be an indication through a red LED in the panel and the HIGH HUMIDITY message on the display. The operator can inhibit the alarm for a period of 15 minutes by pressing the SILENT ALARM key. At the end of such period, if the HIGH HUMIDITY condition persists, the alarm will be reactivated. 19) Alarm of LOW humidity This alarm is activated when the relative humidity is indicated on the display with a difference lower than 15% of the desired value programmed by the incubator operator. In addition to the audible alert, there will be an indication through a red LED in the panel and the LOW HUMIDITY message on the display. The operator can inhibit the alarm for a period of 15 minutes by pressing the SILENT ALARM key. At the end of such period, if the LOW HUMIDITY condition persists, the alarm will be reactivated.

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20) Alarm of UR sensor failure; This alarm is activated when the humidity sensor located inside the newborn compartment fails in reading. In addition to the audible alert, there will be an indication through a red LED in the panel and the UR SENSOR FAILURE message on the display. These alarms cannot be silenced by SILENT ALARM key:




OXYGEN (OPTIONAL);

21) Alarm of oxygen high concentration This alarm is activated when the oxygen level is indicated on the display with a difference greater than 5% above the desired value programmed by the incubator operator. In addition to the audible alert, there will be an indication through a red LED in the panel and the HIGH OXYGEN message on the display. The operator can inhibit the alarm for a period of 15 minutes by pressing the SILENT ALARM key. At the end of such period, if the HIGH OXYGEN condition persists, the alarm will be reactivated. 22) Alarm of oxygen low concentration This alarm is activated when the oxygen level is indicated on the display with a difference lower than 5% of the desired value programmed by the incubator operator. In addition to the audible alert, there will be an indication through a red LED in the panel and the LOW OXYGEN message on the display. The operator can inhibit the alarm for a period of 15 minutes by pressing the SILENT ALARM key. At the end of such period, if the LOW OXYGEN condition persists, the alarm will be reactivated. 23) Alarm of oxygen sensor failure This alarm will be activated when there is a difference in the reading between the two oxygen sensors installed inside the newborn compartment. The alarm activation will automatically stop the oxygen inlet into the newborn compartment. In addition to the audible alert, there will be an indication through a red LED in the panel and the COLD AIR message on the display. The operator can inhibit the alarm pressing the SILENT ALARM key. 24) Alarm of calibration required This alarm indicates that the oxygen sensor needs to be calibrated so the servo control can be used and will be indicated every 10 days or if the system identifies the need. The alarm activation will automatically stop the oxygen inlet into the newborn compartment. In addition to the audible alert, there will be an indication through a red LED in the panel and the CALIBRATE O2 message on the display. The operator can inhibit the alarm pressing the SILENT ALARM key. If the oxygen system is not calibrated and the operator attempts to operate the O2 servo control, the alarm will be activated again;




OXIMETRY (OPTIONAL):

25) Alarm of oxymetry sensor disconnected This alarm will be activated whenever there is a valid measure of SpO2 and BPM and a disconnection of sensor cable of the equipment (by the operator or accidentally). In addition to the audible alert, there will be an indication through a red LED in the panel and the SPO2 SENSOR DISCONNECTED message on the display. The operator can inhibit the alarm pressing the SILENT ALARM key. 26) Alarm of oxymetry sensor misplaced This alarm will be activated whenever there is a valid measure of SpO2 and BPM and the sensor becomes misplaced or come loose. In addition to the audible alert, there will be an indication through a red LED in the panel and the SPO2 SENSOR MISPLACED message on the display. The operator can inhibit the alarm pressing the SILENT ALARM key. 27) Alarm of HIGH SPO2 This alarm will be activated when the percentage of SPO2 read by the oxymetry sensor is above the maximum limit set by the user. In addition to the audible alert, there will be an indication through a red LED in the panel and the HIGH SPO2 message on the display. The operator can inhibit the alarm for a period of 15 minutes by pressing the SILENT ALARM key. At the end of such period, if the HIGH SPO2 condition persists, the alarm will be reactivated.

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28) Alarm of LOW SPO2 This alarm will be activated when the percentage of SpO2 read by the oxymetry sensor is lower than the maximum limit set by the user. In addition to the audible alert, there will be an indication through a red LED in the panel and the LOW SPO2 message on the display. The operator can inhibit the alarm for a period of 15 minutes by pressing the SILENT ALARM key. At the end of such period, if the LOW SPO2 condition persists, the alarm will be reactivated. 29) Alarm of high BPM This alarm will be activated when the heart rate read by the oxymetry sensor is above the maximum limit set by the user. In addition to the audible alert, there will be an indication through a red LED in the panel and the HIGH BPM message on the display. The operator can inhibit the alarm for a period of 15 minutes by pressing the SILENT ALARM key. At the end of such period, if the HIGH BPM condition persists, the alarm will be reactivated. 30) Alarm of low BPM This alarm will be activated when the heart rate read by the oxymetry sensor is lower than the maximum limit set by the user. In addition to the audible alert, there will be an indication through a red LED in the panel and the LOW BPM message on the display. The operator can inhibit the alarm for a period of 15 minutes by pressing the SILENT ALARM key. At the end of such period, if the LOW BPM condition persists, the alarm will be reactivated.

6.5 - CHECK OF ALARMS SYSTEM Use the following procedure to check the alarms operation of the transport incubator. Before you start checking make sure that: - The incubator has no patient on it. - The NB sensor is disconnected from the sensor module. - The power cable is properly connected to the mains. 1- Press ON key on the control panel and check if the display lights and the system boot begins. 2- Go to the Setting screen (See item 6.2 - Turning on the Transport Incubator - model RWT PLUS). 3- Set the desired temperature of 37.0ºC for the air. (See item 6.2.1 - Use of AIR mode). Check if the heating is on. 4- Wait the temperature to stabilize. Open the dome and check if the temperature indicated for AIR on the front panel will fall. The Cold Air alarm should be activated as soon as the temperature indicated for AIR falls below 36.0°C. Close the dome after the alarm activation. 5- Connect the NB sensor on the sensor module and select the NB mode (See item 6.2.2 - Use of NB mode). 6- Set the desired temperature of 37.0ºC for the NB mode. Position the NB sensor at 10cm higher on the center of the mattress. Wait for the temperature stabilization (NB temperature shown in the display should be near the desired temperature, i.e., 37.0°C). Before continuing the test, make sure there is no alarm activated. 7- Remove the NB sensor from the inside of the dome leaving it exposed to room temperature. Verify if activation of the Hypothermia alarm occurs, which should occur when the temperature indicated for the NB is 1.0°C lower than the desired temperature. 8- Place the NB sensor in a container with water under temperature above 38.0°C, for example, water taken from a tap with heater or an electric shower. Check if the increase of NB temperature occurs and is indicated by the control module. The Hyperthermia alarm should be activated when the NB temperature indicated on the display is 1.0°C above the desired temperature. In this situation, the heating indicator should be turned off. 9- Disconnect the NB sensor of the sensor module and check the activation of the NB Sensor Disconnected alarm. 10- Disconnect the cable of the sensor module. Check the activation of the Sensor Module Disconnected alarm. 11- Plug the cable from the sensor module and return the incubator to AIR operation mode. 12- On the Incubator front panel select the condition in "AIR mode" and adjust the temperature to 36.0°C. Allow the system to stabilize for about 30 minutes. After this stabilization obstruct the inlet or output of ventilation in the incubator tray. In the 15-120 seconds range, it shall operate the audible and visual Air Circulation alarm. Let the air passage free. 13- When there is an integrated pulse oximetry, plug the oximetry sensor cable and place the sensor on the skin surface (finger). When the display shows the values of the sensor reading, disconnect the cable from the sensor module. Make sure the Oximetry Sensor Disconnected alarm is activated. 14- If there is a servo controlled humidity, activate the humidification system setting the desired value to 90% humidity. Empty all humidification system through the drain. Make sure the Low Water Level alarm is activated. 15- Disconnect the power cable from the mains. Make sure the Power Failure alarm is activated. - 68 -

16- Press the OFF key located on the control panel. 17- If any tests described do not result in the activation of alarms, request the visit of the nearest service center. Note: - To ensure the patient’s safety, perform this procedure to check the alarms weekly. - The alarms check does not guarantee the perfect operation of the equipment. The temperature calibration and test of some alarms can be done by the service center only. Send your transport incubator to periodic reviews at intervals not exceeding 6 months.

7 - MAINTENANCE After performing any maintenance procedure, make sure that the equipment and its alarms are in perfect working conditions according to the procedure described in item 6.5 - Check of Alarms System. Make sure that maintenance is always performed by qualified personnel, trained in the manufacturer and the replacement parts used are original. Refer to Technical Specifications or call the nearest service center for more detailed information on preventive and corrective maintenance, spare parts, electric and electronic schemes and technical training. CAUTION - Only qualified personnel authorized by the manufacturer should perform the maintenance procedures and review of the transport incubator. - To avoid the possibility of burns while performing maintenance if the transport incubator, make sure that the equipment is disconnected from the mains and the oxygen and air supply is closed or disconnected.

7.1 - PREVENTIVE MAINTENANCE











The maintenance of the Transport Incubator - model RWT PLUS: allows the user and the small patient the full operation of the equipment without any risk to both. For a better equipment conservation and increase the patient safety, before the incubator receives a new newborn, the incubator operator must follow the following procedure: Perform cleaning and disinfection according to this guide. Check the battery charge through the following test: turn on the incubator and select the maximum setting value of air temperature. Disconnect the power cable for a minimum period of 10 minutes. Check the oscillation indicator of the battery charge. During this period, the incubator heating should remain activated. In the event of an oscillation above 20% or these conditions are not observed, call an authorized technician to evaluate the battery and its charge system. Inspect the side cover and front of the acrylic dome with special attention to the locking mechanism which should keep the covers closed, even after the force application towards the dome. Check the incubator stability trying to move it with the brakes of the four casters activated. Check the height adjustment mechanism operation of the holder activating the lock and pressing the incubator down. After reaching the minimum height, check if the holder remains locked in that position. To check the alarms see item 6.4 - Operation of alarms.

Bed The incubator bed should be verified every six months to ensure its correct operation. The technician must perform the following procedure: - Open the side cover of the dome and pull the bed out. Check if the tray is activated before the bed is completely out of the dome. - Check if the bed has no deformation or broken parts. - Check if the mattress is in good condition, with a plastic cover and no rip or sewn pieces. Holder The transport incubator holder should be verified every six months to ensure its correct operation. The technician must perform the following procedure: - Check if all parts are securely fixed. Check the screws fixation. - Check if the casters’ operation are spinning freely and the brakes are working properly. - Check if the height adjustment latch is working. - Check the height adjustment activation; if the dampers are damaged, the descent or ascent movement can appear excessively difficult.

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Body - Check if the incubator body has normal use conditions. There shall be no damaged or defective parts, especially near the fixation points of the dome and the control module. Dome - Check if the incubator acrylic dome has normal use conditions. There shall be no damaged or defective parts. Periodic Review - It is recommended that the transport incubator receives periodic reviews of calibration every 6 months at a service center authorized by Olidef

7.2 - PERIODIC MAINTENANCE The equipment operator must check the following items to ensure the correct operation of the transport incubator. EXAMINED PARTS NB sensor

Auxiliary light bulb Portholes closing Opening and locking of the front and side dome covers Physical state of the mattress Height adjustment mechanism of the incubator holder Dome fixation latch Level of battery charge Incubator lock system (Accessory) Dome/portholes garnishes Humidification sponge Cylinders Solenoid valve Oxygen and humidity hoses Oxygen and humidity O-rings Air filter Particles retention filter External and internal tank Float

MAINTENANCE PERIOD

EXECUTION

Every time the equipment is used Every 2 months Every 2 months Every 2 months Every time the equipment is used Every 2 months Every 2 months Before the patient removal Every time the equipment is used Every 6 months Every 6 months Every 12 months Every 6 months Every 12 months Every 12 months Every 3 months Every 3 months Every 12 months Every 12 months

User Technician Technician Technician User Technician Technician User User User User Technician Technician User/Technician Technician User User Technician Technician


Parts Replacement It is recommended the periodic replacement of some parts suffering natural wear according to the terms described in the table below. The replacements must be made by duly trained personnel. Always use parts provided by Olidef or its authorized service centers. PARTS REPLACEMENT Auxiliary light bulb Rechargeable sealed battery High pressure hose Holder bumpers Air filter Particles retention filter Oxygen valve O-rings Iris sleeve Wrist sleeve AIR buffer Tube passing Mattress Humidity foam Mattress cover Oxygen cell 9V battery

TERM

EXECUTANT

12 months 18 months 12 months 24 months 3 months 3 months 12 months 6 months 6 months 12 months 12 months 6 months 6 months 12 months 12 months 12 months

Technician Technician User Technician User User Technician Technician Technician Technician Technician User User User Technician Technician

CAUTION - Rechargeable battery should only be replaced by technician certified by the manufacturer.

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7.2.1 - AIR FILTER EXCHANGE To replace the air filter (1), unscrew the two screws manually (3) to the end of the course and pull the protective cover of the filter (2) down. Replace the air filter and return it to its original position as shown in Figure 109.

Figure 109 - Air filter exchange

7.2.2 - EXCHANGE OF AIR FILTER OF THE PASSIVE OXYGEN VALVE To replace the air filter of the passive oxygen valve, unscrew the valve inlet nozzle (2) to the end of the course, careful not to cut the O-ring. Replace the air filter (1) and return it to its original position as shown in Figure 110.

Figure 110 - Air filter exchange

7.2.3 - EXCHANGE OF AIR FILTER OF THE LIMITING OXYGEN VALVE To replace the air filter (1), unscrew the valve inlet nozzle (2) to the end of the course, careful not to cut the O-ring. Replace the air filter and return it to its original position as shown in Figure 111.

Figure 111 - Air filter exchange

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7.2.4 - EXCHANGE OF AIR FILTER OF THE SERVO CONTROLLED OXYGEN VALVE To replace the air filter of the passive oxygen valve, unscrew the valve inlet nozzle (3) to the end of the course, careful not to cut the O-ring. Replace the air filter (1) and return it to its original position as shown in Figure 112.

Figure 112 - Air filter exchange




Environmental Protection

Disposal If there is need to dispose the equipment or its parts and these do not have a destination defined by the customer, the item in question must be sent to the manufacturer or the nearest service center for disposal carried out according to current law. Rechargeable batteries used in the transport incubator have limited useful life. After replacement , send the damaged battery to the manufacturer or the nearest service center. Do not throw this material in the trash because the batteries have toxic materials and heavy metals in the composition. CAUTION - Disposal of batteries should be performed in accordance with the laws in the country.

8 - CLEANING AND DISINFECTION 8.1 - CLEANING CAUTION - To avoid the possibility of burns or electric discharges occur during the process of cleaning and maintenance, ensure that the Transport Incubator - model RWT PLUS is disconnected and make sure the heating element is not hot. - Before starting the cleaning and maintenance procedures make sure that the oxygen supply is closed or disconnected from the transport incubator. It may be danger of explosion and fire during cleaning or maintenance in an environment enriched with oxygen. Cleaning the Transport Incubator - model RWT PLUS must be made weekly or after the equipment use according to the following procedure: •

Use a soft, clean cloth moisten in water and mild soap.

•

Remove dust from the plastic and metal surfaces of the equipment.

•

Clean the monitor holder, the serum holder and the incubator holder

•

Clean the NB temperature sensor and the control module taking care not to soak these equipment parts.

•

Clean the entire surface of the incubator's body using a moistened cloth and mild soap.

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•

MATTRESS

1. Remove the mattress inside the NB compartment as shown in Figure 113.

Figure 113 - Removing the NB bed

2. Remove the mattress foam of its plastic cover as shown in Figure 114.

Figure 114 - Removing the mattress foam

3. 4. 5. 6. 7.

Wash the foam and the plastic cover with a detergent solution and appropriate disinfectant properly diluted. Rinse the parts in running water removing any residue of the solution used for cleaning the material Let it dry at room temperature. Replace the foam inside its plastic cover. Replace the mattress in the RWT PLUS incubator bed.

•

NB COMPARTMENT

To clean the NB internal compartment follow the procedure below: 1. To unlock the monitor holder, pull the latch and lift it as figures 115 and 116.

Figure 115 - Unlocking the monitor holder

Figure 116 - Lifting the monitor holder

2. Remove the sensor module, NB connector and the oximetry sensor from the module panel when necessary. - 73 -

3. To unlock the dome, pull the o'ring and remove the dome as shown in Figure 117.

Figure 117 - Unlocking the dome

4. Remove the NB bed pressing the latch located below the bed as shown in Figure 118.

Figure 118 - Removing the NB bed

5. Remove the disinfection cover loosening the knurled screw manually (A) as shown in Figure 119.

Figure 119 - Removing the knurled screw

6. The disinfection bowl and cover can be cleaned with running water or with a moistened cloth and mild soap. 7. Then, dry the parts with a clean cloth or paper towel. 8. Replace the disinfection cover fixing it with the knurled screw. 9. Replace the patient bed in its original position.

•

FAN

1. 2. 3. 4.

Remove the dome. Remove the NB bed. Remove the disinfection cover. Hold the fan (2) and remove manually the knurled nut (1) as Figure 120.

Figure 120 - Removing the knurled nut and the fan.

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5. The fan and the knurled nut can be cleaned with running water or with a moistened cloth and mild soap. 6. Then, dry the parts with a clean cloth or paper towel. 7. Replace the fan and the knurled nut in its original position.

•

DOME

1. Remove the sensor module of the dome, release the nut manually (2) fixing the sensor (1) as shown in Figure 121.

Note: -To remove the sensor module when there is an O2 servo control, remove the screw manually (1) , press the latch drawer (2) and pull out the entire module (3) as shown in Figure 122.

Figure 121 - Removing the sensor module

Figure 122 - Removing the sensor module with O2 servo control

2. Remove the inner dome (1) and clean the external dome (2) of the incubator with a cloth moistened with water and mild soap as Figure 123.

Figure 123 - Removing the inner dome

3. 4. 5. 6.

Figure 124 - Removing the inner dome with O2 servo control

The inner dome (1) can be cleaned using the same process. Then, dry the parts with a clean cloth or paper towel. Replace the dome to its original position and lock the sides. Connect the sensor module in the dome. - 75 -

•

INTERNAL TANK (OPTIONAL)

1. Remove all the water from the tank through the drain at the bottom of the incubator as Figure 125.

Figure 125 - Location of drain

2. 3. 4. 5.

Remove the dome. Remove the NB bed. Remove the disinfection cover. To remove the tank cover release the knurled screws manually as shown in Figure 126.

Figure 126 - Removing the knurled screws

6. Pull the internal tank cover as shown in Figure 127.

Figure 127 - Removing the tank cover

7. The inner tank cover can be cleaned in running water. 8. Dry the parts with a clean cloth or paper towel. - 76 -

9. 10. 11. 12. 13. 14.

Carefully remove the float as Figure 127. Clean the inner tank and the float with water and soap, pass the cloth carefully. Rinse well, in order to avoid overfilling, keep the drain open. Remove all water, close the drain. Reassemble the float in the tank, see the correct position as shown in Figure 127. Replace the cover in its original position and tighten the knurled screws.

•

WATER TANK (OPTIONAL):

1. Remove all the water from the tank through the drain at the bottom of the incubator as Figure 128.

Figure 128 - Location of drain

2. Pull the drawer latch (A) of the tank as shown in Figure 129.

Figure 129 - Location of drawer latch

3. Pull the tank drawer (3) to the limit, pull the tank cover (1) and remove the hose (4) from the nozzle located at the rear of the tank (2) as shown in Figure 130.

Figure 130 - Removing the tank

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4. The tank (2) can be washed in running water or clean with a cloth moistened with water and mild soap or sterilized by autoclaving process at temperatures up to 121ºC for 20 minutes. 5. Then, dry the parts with a clean cloth or paper towel. 6. Return the tank to its original position connect the hose , put the cover on the tank and push the drawer to lock it.

8.2 - DISINFECTION Cases in which the incubator has been used for a child with infectious disease, the disinfection must follow a more strict process. However, due to be a not critical article, there is no need for sterilization of equipment or parts, being sufficient the disinfection only. To do this, make the equipment cleaning following the indications of Item 9.1 - Cleaning. Then, after drying the parts, use a dilute solution of quaternary ammonium for disinfection with very broad spectrum of action but without leaving residue that may get in contact with the newborn body and cause any toxic action. Apply the solution with a clean cloth on the mattress, bed, NB sensor (do not leave this solution comes into contact with the plug of the NB sensor), NB compartment and fan. In the acrylic parts disinfection never use products based on alcohol or ether as these liquids will damage this kind of material. CAUTION - Do not autoclave the foam or the mattress cover. - Do not use solvents or abrasive cleaners to clean the surfaces of the transport incubator. - Do not expose the acrylic or plastic surfaces under the direct radiation of germicidal bulbs. The ultraviolet radiation can cause drying of these materials. -Do not autoclave or sterilize with gas any part of the transport incubator. - For cold sterilization, make sure the product that will be used can be used with plastic and metal materials (chrome and painted). - For immersion in liquids, some chemicals can be harmful to plastics; in case of doubt, consult the supplier of those products.

9 - TROUBLESHOOTING Table of troubleshooting indicates to the user a series of generic occurrences, its possible causes and measures to be taken for possible troubleshooting. If such information is not sufficient to correct the failure, the transport incubator - model RWT PLUS must be submitted to review at the nearest Authorized Service Center. FAILURE The incubator will not turn • on

Main key battery

The air temperature does • not increase • •

Access door open Lack of power Resistance is not heating

Led indication of C.A. • mode does not light off •

The main key is not connected • Mini breakers F1 and F2 • unarmed • The power cable is not connected

Connect the main key and turn on the control panel Reset the mini circuit breakers Check the connection of the power cable

Discharged battery alarm • activated

Battery discharged or damaged

•

Connect the incubator for 24 hours to fully charge the battery or replace the battery

Low oxygen concentration

Access doors open Oxygen inlet tube with leakage Oxygen Valve uncalibrated

• • •

Close doors Exchange tube Make the calibration and measurement

Alarms of hypothermia and • hyperthermia

Activated constantly

• • •

The temperature value indicated for NB is incorrect

The NB sensor plug is poorly • connected The NB sensor is damaged • The NB sensor or fixing • adhesive of the sensor are incorrectly placed on the patient

Check the positioning of the NB sensor Check the desired temperature Check the patient's temperature with a clinical thermometer and compare with the value read by the incubator. If the values are not consistent, contact an authorized service center Insert the of the NB sensor plug in the control module firmly Send it to the Service Center Place the NB sensor and the fixing adhesive correctly (see item 6.2 of this guide)

•

• • •

• • •

CAUSE and

SOLUTION discharged • • • •

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Turn the main key on the control module and press ON on the front panel Close the access doors Check the power supply voltage and the battery voltage Defect in resistance

10 - WARRANTY The Olidef cz Indústria e Comércio de Aparelhos Hospitalares Ltda assures to the owner of the Transport Incubator - model RWT PLUS, warranty against any defect of material or manufacturing submitted within twelve (12) months from the purchase date by the first acquirer. The warranty responsibility is limited to repair or replacement of defective parts and manufacturing and setting repairs that may be necessary to operate the unit within its specifications provided it is performed at the company headquarters at Avenida Patriarca, 2223 - Ribeirão Preto or service centers of Olidef with expenses and risks of transport and packaging by the owner. It is excluded from this warranty the defective parts by natural wear such as power cable, mini resettable circuit breakers, bulbs, seals, etc.. This warranty is void if the equipment, at Olidef criteria, has suffered damage by accident, fall, or show signs of sets or attempts or repair by unauthorized persons. Any change or extension of warranty and strict conditions of this term will only be valid when taken in writing directly by Olidef.

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