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1. EE 69 9 APPARATUS SPECIFIC FUNCTIONS AND 9 70 OC LEANING THE APPARAT ITS S u a 71 11 PROGRAMMED AND PREVENTIVE 0 000000000000000000000 72 11 1 ELECTRICAL SAFETY PARAMETERS CHECK u ulaqa ai uns 12 Ginevri s r l 8070bmd 01 03 2010 qd 11 OGB PolyTrend User manual 11 2 METHOD OF USE FUNCTIONING AND MAINTENANCE 73 LE WEATIN TENANCE MICROSPEID LEER Sd 74 LI SENSOROSUBSTDEPESPEIORN uu y anu SC rec 74 12 ELECTRO MAGNETIC INTERFERENCE AND OTHER 1 0 000 000000 0000000004 75 19 PABEL WARNING mb u mienne n unu MM m m UN eee 76 I VIP Up ms ls 80 ENIR TANDEXITSIGNALCFPOR T2 ne rito E E 81 16 CLEANING DISINFECTION AND STERILIZATION OF THE PARTS IN CONTACT WITH THE PATIENT82 17 POWER SUPPLY WITH ADDITIONAL POWER SUPPLY SOURCES 85 PS BART ERY 85 IO ISE CHAROBEABLE BATTERIESo d N EA AN
2. Before taking the control panel out always turn the Incubator off and leave it to cool down for at least 30 minutes and disconnect the power lead In this way you avoid any elec trical or thermal problem for the operator Ginevri s r l 8070bmd 01 03 2010 53 11 OGB PolyTrend User manual 6 5 DETECTING PROBES GROUP ASSEMBLY Insert the probe group in the hood through the special housing and fix it with the threaded ring x The skin temperature probes have to be connected Internally to the probe group by the special connectors paying attention to the connectors colours as indicated in the figure Air temperature probe Humidity probe Skin temperature probe SKIN 1 Skin temperature probe SKIN 2 54 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual 11 6 6 HUMIDIFICATION SYSTEM OGB PolyTrend Incubators can accommo date standard humidifier that consists of a wa ter reservoir made of pressure fusion poly carbonate located in the base of the incuba tor see pages 36 and 37 6 7 Servo Steam humidifier which comes with the same water reser voir as the standard humidifier and there fore is interchangeable with it With respect to the standard version it has some modifications which make it completely separate from and isolates the vapour from the environment re served for the patient An internal wall serves this purpose Given that with the Servo
3. 11 PolyTrend User manual Maintenance service Ginevri representative in your country can stipulate within one month before warranty period expiry various kinds of maintenance contract For any inquiry please contact us GINEVRI s r l Servizio Assistenza Clienti Via Cancelliera 25 B 00041 Albano Laziale Roma Italy tel 06 93459331 fax 06 93459393 E mail export ginevri com WWW ginevri com The device 1s manufactured compliance with the standards CEI 62 5 file 1445 of 01 91 and EN 60 601 1 and related IEC 601 2 50 Moreover the device 1s provided with an EMC electromagnetic compatibility anti jamming device If servicing maintenance after warranty period is performed by other companies qualified authorized by us all fixed parts have to be marked by the repairer The repairer has to verify and guarantee writing the perfect functioning of the device Any modification of the device must comply with the Medical Devices Normative law 93 42 and approved by Ginevri s r l For maintenance service original materials must be used 4 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual 11 2 EC CERTIFICATE Certificate EC CERTIFICATE Certificate No 747 MDD Infant intensive care incubators Type ref OGB Poly Care 1 OGB Poly Care 2 Poly Care 3 OGB Poly Gare 4 OGB palytrend Trade mark Transport infant incuba
4. 9 WARNING The attachment and detachment of the connectors must always be done when the incuba tor is turned off RIGHT SIDE VIEW OF THE CONTROL PANEL O AN O 6 Power On Off switch 7 Oxygen probe Connector of the oxygen concentration reading sensory probe 8 Power supply electrical power plug 9 Sensor probe for reading the oxygen concentration in the air 10 Support for the oxygen sensor and its cali bration 11 Remote Monitor Cable Connector optional 56 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual 11 7 ACCESSORIES Code Description Immagines Ref TROLLEY WITH FIXED CENTRAL COLUMN Un Un 11400 70 TROLLEY WITH HEIGHT ADJUSTABLE CENTRAL COLUMN 2 11410A70 3 12393A70 DOUBLE HOOD HEADBOX MICRO CLIMATE 30x20x13 HEADBOX MICRO PET CLIMATE 35X25X15 1521 IV POLE COMPLEX 6922 IV POLE STANDARD 722 BED BASIN Ginevri s r l 8070bmd 01 03 2010 57 11 PolyTrend User manual 11401A70 SERVICE DRAWERS 11405 70 SERVICE WORK TRAYS NEONATAL HEAD IMMOBILIZER 5740 JOINTED SHELF MOVEABLE 10712470 INTUBATION SUPPORT SUPPLEMENTARY 1200347 POLYTREND MONITOR 12030A70 INTEGRATED BILLA 11459A70 PULSE OXYMETER 58 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual 11912A70 The hood with a silent hinge Pack of 2 Note This accessory can be mounted
5. Activate PROBE ALARM SKIN probe OK Goes to AIR MODE YES READ AIR TEMPERATURE Tair READ TEMPERATURE SET Tset READ TEMPERATURE SKIN Tskin NO HEATING OFF YES Heating OFF if HIGH TEMP Tair gt 39 C Alarm cannot Be silenced PROPORTIONAL HEATING HIGH TEMP ON Alarm activate LOW TEMP Alarm activate 28 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual 11 5 5 STANDARD HUMIDIFICATION SYSTEM The standard humidification system consisting of a basin pressure fusion stamped out in polycarbonate located in the rear part of the incubator base The basin s transparency permits constant monitoring of the basin s water level The variation of the humidity level up to about 9094 is obtained through the use of a deflector controlled by the specially designed lever which depending on the position it is set in with respect to the hot air coming from the heating chamber allows the desired humidity percentage to be reached in the hood interior The water basin can be taken out of the base with a simple pressure simultaneously on the two fixing levers located on the right and left sides of the basin itself This dismantling capability permits the basin to be cleaned and sterilized every time that it 1s felt to be necessary It is recommended to frequently carry this operation even several times a day This takes into consideration the fact that it is no
6. NO YES AIR TEMPERATURE gt 40 C Activate MAX TEMP ALARM FAN FAILURE ALARM ACTIVATE The circulation Fan turning Activate PROBE ALARM AIR sensor OK 9 READ AIR TEMPERATURE Tair READ TEMPERATURE SET Tset AN HIGH TEMP Alarm activate HEATING AN LOW TEMP Alarm activate 24 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual 11 TEMPERATURE TREND DISPLAY SCREEN EEUU Us 211 ME Es FIGURE TREND DISPLAY SCREEN e ALARMS area reserved for description of the activated alarms in the upper part of the screen replacing the GINEVRI name air internal air temperature of the hood skin1 patient skin temperature check skin2 patient skin temperature peripheral S1 a active area to visualise the Temperature Trends given by the difference between the SKIN and AIR sensor probes 51 52 active area to visualise the Temperature Trends given by the difference between the SKIN sensor probe and the PERIPHERAL sensor probe 3h 6h 12h 24 48h 7gg active are to visualise the relative Trends The Temperature Trend display is composed of graphs of the three monitored tempera tures on the base axis of each graph is shown the time while on the vertical axis the re ported temperature values are shown The first time on the left indicates the time the incubator was turned on Eve
7. The Incubator upon switching on or Resetting if the oxygen sensor probe is not inserted in the calibration holder the concentration reading system will indicate the necessity for the sensor probe to be calibrated showing on the LCD display in the oxygen reading part of the screen the symbol In this case all the alarms relating to oxygen are disabled In the case of on switching on or Re setting of the incubator the probe is found to be inserted in the calibration holder the calibration procedure will automatically lai P 32 1 Tskini 30 commence signalling to the operator on the LCD display in the oxygen reading part of c 32 0 Tskinz 2 9 1 7 the screen the writing CAL At the end of se RAE the calibration the CAL writing will be substituted by the air oxygen concentration level ie 21 Always remember that if on switching on or Re setting the incubator the oxygen sensor probe connector is not connected the servo control and monitoring and all the alarms connected to the oxygen sensor probe are completely disabled If instead the disconnection of the oxygen sensor probe occurs during normal use the OXY PROBE DISCONNECTED will activate thereby advising the operator of the disconnection In this last case by pressing on the MUTE button you will have the possibility to disable the oxygen servo control monitoring and all the alarms relating to oxygen If at the end of the
8. PolyTrend User manual m ki 41210 gt DISPLAY MENU TREND active area to access the Trends SCALE active area to access the Scales Display SpO active area to access the Pulse Oxymeter Display SETTINGS active are to access the Settings 1 return return to the Numeric Data Display SETTINGS DISPLAY ALARMS area reserved for the description of the active alarms will appear in the upper area in place of the word Ginevri TIME active area to access the clock setting ALARMS active area to access the settings for the alarm management by the user DISPLAY active area to access the brightness of the dis play TECHNICAL active area reserved for authorized techni cians return return to the Numeric Data Display 20 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual 11 OXYGEN TREND WEIGHT TREND Ginevri s r l 8070bmd 01 03 2010 21 11 OGB PolyTrend User manual 22 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual Rev 11 5 3 THERMO REGULATION IN AIR MODE AIR MODE d 8H nuls 32 Tskint 30 8 32 4 Tskin2 3 1 FIGURE AIR MODE The OGB PolyTrend incubator allows for carrying out thermo regulation in AIR Mode AIR setting values between 20 C 39 with 0 1 incremental steps To select the Mode function AIR press on the AIR SKIN but
9. 6 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual 11 Index I PRESSBNTACEION 2 otii rode tes nc 3 2 He CER UPI ATE a ence lobi Nar 5 j P dale tee 10 REUSE PRECAU THON S uya a usa am asam qa ber 10 3 2 ELECTRICAL AND AGAINST EXPLOSIONS PRECAUTIONS 11 Ay GENERADPIC 12 ASE INERODU TION 13 42 TBCNODOGY AND MATERIA ES ts bett bee 14 OPERA S Sa mm mem 16 SM EO SENSN IIR DS 17 5 2 MANAGEMENT OF THE DIFFERENT VISUAL DISPLAYS pirni ia raa asri adn ia aii 18 5 3 THERMO REGULATION IN AIR MODE AIR 1 200044000 00000000000000000000000002000 23 5 4 THERMO REGULATION IN SKIN MODE SKIN 2 2 1 1 40 40000011010000000000000000000000000020000 26 5 5 STANDARD HUMIDIFICATION SYSTEM rremanetan er desea anas 29 5 6 SERVO REGULATION OF THE HUMIDITY LEY El au 31 5 7 OXYGEN SERVO CONTROL AND MONITO
10. 82 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual 11 Before carrying out the above procedures the incubator must been switched off for at least 30 minutes WASHING REBRIL SOLUBLE DETERGENT FOR THE TREATMENT OF WASHING DISINFECTION STERILIZATION OF MEDICAL EQUIPMENT AND PARTS ART 1711 e detergent in powder form slightly alkaline and easily soluble in water It has the D L G Quality Mark and corresponds to the exact washing and disinfection needs required in various fields also industrial and food production e thasthe advantage of having a combined detergent action chloro active Does not effect or mark in the least plastic materials rubber or light metals tin aluminium and related alloys and stainless steel It is protective of the user s skin Softens the water and impedes calcium lime deposits Block the formation of deposits on the specially treated surfaces Made up of Active Chlorine gr 2 4 Inorganic sodium salts silicates carbonates phosphates gr 96 Surface active Anionics alkaline sulphates sodiums gr 1 6 METHOD OF USE Completely dissolve the required quantity of detergent in water 50gm in 10litres of normal water at an ambient temperature or not above 25 C e Dismantle the various parts to be washed and sterilized e Carry out a pre wash of these parts with lots of water at ambient temperature e Carry out the washing wit
11. OGB PolyTrend User manual 11 PolyTrend 8070 Intensive Care Incubator User Manual Ginevri s r 8070bmd 01 03 2010 1 11 PolyTrend User manual THIS MANUAL HAS BEEN PRODUCED RESPECTING THE CURRENT STANDARDS This manual refers to the enclosed equipment OGB Polytrend INCUBATOR S N 2 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual 11 1 PRESENTATION Presentation Dear Customer Ginevri thanks you for choosing our firm and the quality of our products The longstanding Ginevri traditions of professionalism reliability and availability will once again prove to be your best reward for entrusting us at Ginevri with your neonatal purchases Giorgio Ginevri GINEVRI s r l Registered office Via Cancelliera 25 B 00041 Albano Laziale Roma Italy N Warning This manual must be carefully read by all personnel who install use or maintain these units The operation of this equipment in accordance with the instructions contained in the user and service manuals combined with regular service maintenance performed with Ginevri original spare parts and consumables will assure the efficiency of our devices and the long lasting quality of their performance and reliability Maintenance and service must only be performed by technicians who have been trained and authorized by Ginevri Ginevri s r l 8070bmd 01 03 2010 3
12. 20 APPARATUS WITH SPECIAL POWER SUPPLY OR BATTERY RE CHARGER There are no apparatus with special power supply or battery re charger 21 ECO COMPATIBLE RECALL and DISPOSAL This apparatus 15 electro medical device and therefore does not come under the scope of the RoHs Directive Conforming to the Directive 2002 96 CE known as the RAEE Directive and to the implemented Italian legislation our electronic and electrical apparatus are marked with the symbol shown below provided for by the CEI EN 50419 Standard This apparatus must not be disposed of with domestic rubbish garbage For RECALL of rejected equipment please contact our Customer Assistance Dept see the first pages of this manual The apparatus at the end of its useful life must be disposed of according to the Standards in force at that time Ginevri s r l 8070bmd 01 03 2010 55 11 22 TECHNICAL CHARACTERISTICS INCUBATOR BODY ELECTRICAL POWER SUPPLY ELECTRICAL CONSUMPTION SAFETY CLASS IEC 601 1 CEI 62 5 CATEGORY IEC 601 1 CEI 62 5 MEDICAL DEVICE CLASS 93 42 CEE EARTHING CURRENT ELECTRICAL PROTECTION POWER SUPPLY FAILURE ALARM AIR TEMPERATURE INDICATOR SKIN TEMPERATURE INDICATOR O2 CONCENTRATION INDICATOR HI LOW O2 CONCENTRATION ALARM INDICATOR THRESHOLD ALARM HUMIDITY INDICATOR INSIDE THE HOOD TEMPERATURE SETTINGS LIMITS MAXIMUM TEMPERATURE ALARM HUMIDITY CONTROL IDEAL ROOM TEMPERATURE AMBIENT HUMIDITY VARIATION STORAGE
13. e Upon Switching On the Mute and Air Skin buttons must be kept pressed simultaneously for the default setting of the oxygen temperature and humidity to be memorized in the non volatile memory e The micro filter which is highly efficient and 1s positioned in the tubing system for air taken in from outside must be kept clean It s substitution 1s recommended at least once per month However a good standard practice is to change it for every patient 3 2 ELECTRICAL AND AGAINST EXPLOSIONS PRECAUTIONS Check the Earth Connect the AC power supply connector only to a 3 pin hospital standard so cket Do not use extension leads If there are any doubts about the earthing do not turn the equipment on If the Control Panel is opened be careful because there is a risk of electrical shock inside the panel itself Maintenance must only be carried out by qualified personnel Make sure the electrical power supply level is compatible with the electrical specifications displayed on the incubator label Do not use the incubator in the presence of inflammable anaesthetics Make sure the incubator s oxygen flow 1s disconnected when it 1s being cleaning or having main tenance carried out because there 15 a risk of explosion when cleaning and maintenance operations are carried out in an oxygen rich environment Lighting cigarettes and all other potential causes of fire must be eliminated from where the incubator is used Fabrics oils and other combustible
14. si evidenziano residui di pulviscolo ATTENZIONE Un microfiltro sporco aumenta la concentrazione di anidride carbonica nell incubatrice Le incubatrici della linea Poly Care sono state certificate utilizzando il microfiltro P N 11130A72 Lo Ginevri non si assume alcuna responsabilit per malfunzionamenti derivanti dall impiego prolungato dei microfiltri e o dall impiego di microfiltri diversi M It is advisable to change the microfilter for each new patient and whenever traces of dust are visible ATTENTION dirty microfilter might increase carbon dioxide concentration inside the incubator The Poly Care line incubators are certified using the microfilter P N 11130A72 Ginevri cannot be re ble for any malfunctioning due to the use of dirty microfilters and or any other type of microfilters Re order P N 11130A72 cx www ginevri com Ginevri s r 8070bmd 01 03 2010 79 11 PolyTrend User manual 14 STANDARDS The OGB PolyTrend IS BUILT ACCORDING TO THE FOLLOWING STANDARDS EC 1601 1 CEI 62 5 EC 601 2 19 501 61000 42 61000 4 3 16100044 2 16100045 161002477 2 MEDICAL DEVICE 93 42 CLASS IIb TT TI TI TI Z SINGER UNI ISO 9000 2000 CERTIFIED QUALITY SYSTEM BY IQNET No CERT IT 37100 wawam UNI CEI ISO 13485 PAR
15. 4 Rotate clockwise to increase the humidity value setting and anti clockwise to decrease that value 5 Press the encoder to terminate the operation otherwise the operation will be automatically terminated after a few seconds Verify that the humidification holder of the Servo Steam is correctly connected ac cording to the instructions furnished in the incubator assembly section To avoid the formation of chalk deposits in the evaporation heating chamber we suggest the use of distilled water The relative humidity can be varied in 1 steps The pre set relative humidity value is memorized in the hard drive and is saved in case of power failure At high levels of relative humidity the formation of condensation on the inside walls of the incubator hood can occur The condensation formation will be more consistent and substantial the greater the difference in temperature between the temperature inside the of the incubator and the outside ambient temperature 32 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual Rev 11 HUMIDITY TREND DISPLAY SCREEN GINEURI HUMIDITY TREND L tU k Eu O T f du 4 r r r _ i mk _ gt FIGURE HUMIDITY TREND DISPLAY SCREEN ALARMS area reserved for description of the activated alarms in the upper part of the display replacing the GINEVRI name air internal air temperature of the hood skin1 patien
16. 8 CLOCK GINEURI FIGURE TIME SET DISPLAY SCREEN e ALARMS area reserved for description of the activated alarms the upper part of the display replacing the GINEVRI name e SETTING HOURS shows the hours of the clock it is possible from this field to modify the internal clock time in this case data from memorized trends will be cancelled e SETTING MINUTES shows the minutes of the clock it is possible from this field to modify the internal clock time and in this case data from memorized trends will be cancelled e return return to the Numerical Data Display Screen Ginevri s r 8070bmd 01 03 2010 41 11 OGB PolyTrend User manual 5 9 TIME SETTING GINEURI FIGURE viewing the time with the selected field The incubator is equipped with an internal clock for management of the trends It is pos sible to set the hour and the minutes of the internal clock from the TIME screen To ac cess that screen from the Numerical Data Screen select the Menu field and press the en coder From the Menu screen select the Settings field and press the encoder from the oettings screen select the Time field and press the encoder From the Time screen 1 Press the Block button 8 if the encoder is blocked with the corre sponding LED then turning off Rotate the encoder until the desired hours or minutes are selected Press the encoder to activate the setting Rotate clockwise direction to
17. increase the hour or the minute to set and anti clockwise to decrease those values Press the encoder to terminate the operation otherwise the operation will be automatically terminated after a few seconds Setting the Time brings also results in the cancellation of all the memorized trend data because the samples were taken at times corresponding to a different reference system consequently the trend graphs will return to the original axis 42 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual 11 5 10 SETTINGS DISPLAY Ginevri s r l FIGURE SETTINGS DISPLAY ALARMS area reserved for the description of the alarms which are active will appear in the upper area place of the writing CONTRAST indicates the contrast setting for the display The contrast is modifiable by selecting the active area and turning the encoder to increase or decrease the intensity BRIGHTNESS indicates the brightness setting for the display The brightness 1s modi fiable by selecting the active area and turning the encoder to increase or decrease the brightness return return to the numerical data screen 8070bmd 01 03 2010 43 Rev 11 OGB PolyTrend User manual 5 11 TECHNICAL SETTINGS 44 FIGURE TECHNICAL SETTINGS DISPLAY SCREEN ALARMS area reserved for the description of the alarms which are active will appear in the upper area in place of the writing GINEVRI WORKING HOURS Visua
18. is attached to the control panel and therefore to extract it is necessary to take the control panel itself out by working on the four chrome rounded fixing bolts see photo page 15 The heating element be cleaned also by bathing it with sanitizing liquid In this phase it is necessary to take particular care to avoid having the liquid get into yhe control panel where all the electrical components are installed WARNING When it is necessary to take the control panel out of the incubator base take care because the heating element could be fairly or even extremely hot Before carrying out the operation mentioned above the incubator must have been turned off for at least 30 minutes beforehand Ginevri s r l 8070bmd 01 03 2010 71 11 OGB PolyTrend User manual 11 PROGRAMMED AND PREVENTIVE MAINTENANCE electro medical devices must be maintained regularly as for the normative law CEI 1276 The aim of preventive and programmed maintenance 1s to minimise the need of faults repairing and to ob tain e Correct functioning e Safety for the patient the operator and the surrounding environment e Maximum availability of the device Preventive maintenance consists in controls performed by the operator and periodical maintenance Written programs should be defined regarding every kind of device based on laws technical standards and sugges tions of the manufacturer These programs must include controls performe
19. materials are easily inflammable and burn with a great intensity in an oxygen rich atmosphere Ginevri s r l 8070bmd 01 03 2010 11 11 OGB PolyTrend User manual 4 GENERALITY The philosophy which has guided Ginevri in the design of its equipment over more than 40 years of manufacture has always been the same The use of modern advanced techniques coupled with extreme simplicity of use cleaning and sterilization This philosophy has lead to the OGB PolyTrend line of Incubators The OGB POLYTREND incubators are controlled by a micro processor system which checks monitors and visualizes all the parameters and functions necessary in order to create an ideal micro climate for the premature baby According to the version of the OGB PolyTrend selected it is possible to regulate and check the following parameters e Air and Cutaneous Temperature Air Skin with servo controlled and proportional heating systems e Humidity servo controlled and with an integrated system for the generation of sterile humidity e Oxygen concentration inside the hood or head box servo controlled The setting of the parameters is done thru the use of soft touch buttons and an encoder arranged in an easy to use error free fashion On request it is possible to connect to a Local Area Network and monitor with a remote system an unlimited number of incubators The intensive care incubators can be equipped with a radiant heat Hot Spot whic
20. only in factory Ginevri s r 8070bmd 01 03 2010 Rev 11 59 11 OGB PolyTrend User manual 7 1 INTEGRATED BILLA SCALES 12030A70 OPTIONAL 7 1 1 General The Billa is a precision electronic scale designed and created by Ginevri specifically to be used inside the PolyTrend incubator The design philosophy which has guided it crea tion is always the same e High sophistication and technology internally e Simplicity of use and maintenance of the exterior The scales come integrated inside the PolyTrend incubator and is totally controlled and managed from the its own control panel by using the encoder The scales are made up of a weighing plate which can be integrated into the incubator s patient holder tray The micro processor acquires the data furnished by the charge cells and taking advan tage of sophisticated measurement algorithms and rejection of electrical disturbances permitting an accurate and repeatable reading with a precision level superior to that found with normal weighing systems In addition the micro processor facilitates the implementation of a series of functions which simplify the weighing of the newborn Simply by pressing on a button it is possible to see the weight variations of the newborn during the day calculate the difference between net and gross weight and show the weight changes All of this with a precision greater than 2 grammes 7 1 2 Warnings The Billa is a precise me
21. possible to have a pulse oxymeter INSTALLED ESCLUSIVELY IN THE FACTORY The pulse oxymeter sensor probe connector is positioned on the front panel in the bottom right as shown in Figure 1 The sensor probe 15 made up of two parts one re usable and one disposable single use The activation of the pulse oxymeter is positioned on command found in the diagram dedicated to Figure 4 Before starting the monitoring of SpO2 and of the Pulse Rate e Set the relevant alarms e Check that the values shown are stabilized On the principle display screen it 1s possible to see the SpO level and the Pulse Rate measured in the frame in the bottom right see Figure 2 To access the display that manages the pulse oxymeter s alarms from the principle menu you need to select the Menu field using the encoder and access the next display screen Figure 3 clicking on it Select the SpO and click again The display screen will appear as in Figure 4 By turning the encoder it is possible to select the fields for MAX SpO alarm MIN SpO Alarm MAX Pulse Rate Alarm MIN Pulse Rate Alarm Deactivation of the Alarms By clicking on one of the selected fields and turning the encoder it 1s possible to change the alarm settings confirming the choice by press ing on the encoder The MAX SpO alarm can be disabled by setting it to over 100 The maximum possible setting level for the MIN SpO alarm is the level set for the MAX alarm The MAX P
22. shown The first time on the left indicates the time the incubator was turned on Every graph has a vertical line showing the current time Ginevri s r 8070bmd 01 03 2010 37 11 OGB PolyTrend User manual To carry out the calibration position the sensor probe in the provided calibration holder proceeding as indicated in the figure and taking care that the knob sticking out of the body of the sensor holder goes into its matching groove The insertion in the sensor holder automatically activates the calibration procedure which lasts roughly 2 minutes shown by the indicator on the LCD display The incubator at the end of the calibration procedure will set itself in Monitoring Mode and the screen will show the current o xygen concentration level reading in the display screen frame dedicated to that re ading Attention Always carry out the sensor calibration in an environment with an air oxygen concentration level equal to 21 If you do not follow this procedure then false readings or probe malfunction alerts can occur After calibration and before use it is always very useful to verify the calibration itself with a known oxygen concentration The most easily available calibration gases are air 21 and pure oxygen 100 Finally to obtain a more stable reading of the FiO2 it is important that the sensor probe is at the same temperature as the patient environment therefore leave it inside the ho
23. the figure When the door panel is properly closed its lower red edge 15 not visible 52 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual 11 6 3 MICRO FILTER NON PERVIOUS Micro filter leads to e Incubator internal air contamination Limitation of the quantity of air in circulation o e Limitation of the oxygen concentration e Increase of carbon dioxide In any case it is recommended that the filter be changed when there is evidence of dust in the incubator and more importantly change of filter with every change of patient Do not try to clean wash or sterilize the micro filter in order to re use it To change the micro filter Take off pulling it the special cover using the provided indentation found on the right side of the cover itself Clean it along with the housing and then insert the new micro filter in the right direction after having written the date of substitution in the space provided on the bottom right of the micro filter itself which must be easily visible from the outside kuwa N B Ginevri does not assume any responsibility for eventual malfunctions of the equipment or damage to people and or other devices resulting from the use of other types of micro filter 6 4 CONTROL PANEL The control panel be put in or taken out of its housing in the base of the incubator simply by unscrewing the rounded chrome knobs
24. the page will be re designated with the newly selected setting 7 1 12 Visualization of the scale s inclination The integrated balance 15 able to weigh the baby even in inclined positions showning on the screen the real weight In this case the degrees of inclination will be displayed on the screen to the side that the scales have been raised by showning the measurment in the number of degrees and an indication bar When the scales weigh in this inclined mode the precision is affected by 5 gr In any case it is not possible to zero the position when not horizontal 7 1 13 Zero inclination In this case on the screen the will be shown the scales position even when horizontal the calibration from zero inclination should be re done To do this put the scales plate flat and on the incubator s principle menu display select Menu and press the encoder then select SETTINGS and press the encoder select TECHNICAL and press the encoder and finally turn the encoder to select the command 0 Incl and press the encoder To exit from the screen select RETURN and press the encoder Check that on the scale s display screen the inclination has returned to zero This setting will be memorized even when the machine has been turned off until the zero ing procedure has been carried out again 66 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual 11 7 2 PULSE OXYMETER 11459A70 OPTIONAL Integrated into the PolyTrend incubator it is
25. to the touch e The Incubator must only be unplugged from the main power supply after it has been switched off A strict preventative maintenance programme is recommended in conjunc tion with very thorough and complete cleaning and disinfection of the incubator always strictly following the manufacturer s recommendations and frequency 10 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual 11 The incubator incorporates for the micro climate circulation an electrical induction motor par ticularly quiet 45 dB inside the hood Wear and tear the motor arm bushings after proximately 5000 hours of use can cause an increase in internal noise levels It is therefore recommended that the internal noise level of the incubator is periodically tested to make sure they stay inside the safety levels and forewarn when the motor needs to be replaced when that level has been reached e Take care when closing the access doors of the hood to make sure that they are inserted into their holders e For safety and security do not leave the baby unattended when the access door is open e Two people fairly strong are needed to lift the incubator A pre heating regime of approx 30 minutes is needed when the incubator is first turned on before use Therefore a good and safe standard procedure is to wait until the internal temperature of the incubator has stabilized at the desired level before putting the patient inside
26. word WEIGHT At this point the scales are ready to weigh 62 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual 11 7 1 6 Base Functions Use of the Billa Electronic Scales is very simple To weigh a baby place it on the tray and read the weight on the display During cleaning operations it is recommended to disconnect the scales from the incubator 7 1 7 Using the scales To use the scales you need to use the PolyTrend incubator s control panel as shown in the Figure CGINEVHI Toet 35 0 Tskin2 35 1 an H m Gissa in Via sisan 6042 D aca ima ores Hoy aram gue com 1 The encoder allow the selection of the desired function for managing the incubator To use the encoder you are referred to the PolyTrend incubator s manual 2 The Scales button calls up the scales display and permits you to return to the incubator s princi ple display screen after the use the of the scales has been finished 3 The Block key blocks and unblocks the use of the encoder to avoid accidental or non essential settings To access the Scales Display simply press the Scales button or with the encoder on the principle display select Return and then Scale menu If the encoder block light comes on you need to press the Encoder Block key before being able to use the encoder Ginevri s r 8070bmd 01 03 2010 63 11 PolyTrend User manual 7 1 8 Description of the Sca
27. 94A25 Oxygen probe label code 10396A25 Oxygen label on the base code 10428A25 In ossigeno terapia verificare il valore della concentrazione di ossigeno con un analizzatore When oxigen is supplied check the concentration with an oxigen monitor Entrata Ossigeno Oxigen Inlet Ginevri s r 8070bmd 01 03 2010 77 11 OGB PolyTrend User manual Servo steam probe label code 10660A25 SERVO STEAM Water inlet mini label code 10661A25 WATER INLET Oxygen Warning label cod 10662A25 ATTENZIONE OSSIGENO WARNING OXYGEN Distilled water label cod 10665A25 A warninc UTILIZZARE PREFERIBILMENTE ACQUA DISTILLATA DISTILLED WATER IS RECOMMENDED Oxygen support label on the hood cod 11159A25 SUPPORTO SENSORE OSSIGENO Per la corretta operativit della sezione ossigeno e dell unit Hot Spot posizionare la sonda ossigeno nel supporto A OXY SENSOR SUPPORT To have correct operation of the oxygen and Hot Spot unit position the sensor in the housing 78 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual 11 New filter label 11372 25 d GINGVRI up i Air inlet Microfilter C E for Poly Care Incubators date of installation Re order P N 11130A72 OGB filterholder label code 11373A25 GIN RI Si consiglia la sostituzione del microfiltro ad ogni cambio paziente e comunque quando
28. ANEL HE er s ne l 31 45 967 E 11 HEHU Cima eri if via WE OMS T sc chama homa HO acm gme m DE FIGURE CONTROL PANEL 1 Power button located on the left side of the control panel with a warning light if the switch is pressed without a power supply the Power Failure Alarm will sound On the switch filter block you find the electrical supply wire and the machine s two protec tion fuses 2 Liquid crystal display LCD on which the various values taken from the incubator s sensors are seen as well as the control alarms 3 Mute button when pressed this silences the sounding alarms for approx 15min 4 Alarm red LED the LED lights up with the activation of any alarm If the alarm is muted the LED continues to flash until the acoustic alarm comes back on by itself af ter 15 min the LED turns itself back on without flashing 5 Power green LED lights up when there is a power supply turned on 6 Power Failure red LED lack of power alarm which activates in case of lack of 220V power supply 7 N orange LED this LED turns on when the selected temperature is above 37 or the selected oxygen concentration is above 40 8 Block button with LED light this button is used to enable or disable the encoder with the accompanying turning on or turning off of the LED 9 Encoder is used to set the control par
29. CTED Alarm is ac tivated 8070bmd Power supply not turned on The protective fuse has blown The power supply cable has been unplugged Outside source of heat Air circulation system is blo cked Breakdown of the fan and or of the motor Door s left open SKIN sensor probe not well attached to the skin only in SKIN MODE The Skin probe connector is not correctly attached Probe assembly connection is not properly installed The water level is low in the humidifier Calibration not carried out cor rectly Oxygen probe connection is not properly installed 01 03 2010 Press down the POWER switch Change the fuse Verify the power cable is cor rectly plugged in Take precautions to eliminate the source of external heat Remove the obstruction Change the fan and or the mo tor Close all the doors Check the positioning of the SKIN sensor probe Verify that the Skin probe con nection is correct Check the probe assembly connection is properly done Check the water level Repeat the calibration proce dure Check the correctness of the oxygen probe installation Ginevri s r l OGB PolyTrend User manual 11 17 POWER SUPPLY WITH ADDITIONAL POWER SUPPLY SOURCES There are no other power supplies with additional electrical sources 18 BATTERY REMOVAL There are no removal batteries 19 RE CHARGEABLE BATTERIES There are no re chargeable batteries
30. EA umu ss 85 20 APPARATUS WITH SPECIAL POWER SUPPLY OR BATTERY RE CHARGER 85 21 ECO COMPATIBLE RECALL and DIS POS ARS cadet restera tee 85 22 EECHNICALCHARACIBRLDISTICS a N a mosai 86 8 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual 11 white page Ginevri s r l 8070bmd 01 03 2010 9 11 OGB PolyTrend User manual 3 WARNINGS Incubator must only be used by qualified personnel specifically trained and under the super vision of qualified medical staff conscious of all the benefits and risks involved with the use of the incubator itself Notwithstanding that we still recommend the following precautions 3 1 USE PRECAUTIONS e Direct sunlight and other types of radiant heat heaters phototherapy lamps radiators etc raise the Incubator s internal temperature be careful The Incubator 1s equipped with both vi sual and acoustic alarms HIGH TEMP MAX TEMP to alert staff to this problem e The use of oxygen raises the risk of fire Do not introduce into the interior of the incubator ac cessories which could produce sparks Small quantities of flammable agents such as alcohol and ether in the presence of oxygen can cause fires e When oxygen is administered you must you an analyser to check the oxygen percentage of the oxygen in the air mix The introduction of oxygen with o
31. RING SYSTEM rennen nennen nennen nnns 34 SOC OCR PET Tcr MR MT TT 4 STIME Dnm TE 42 SO SETFINGS DIS PLAN dT Sa iu 43 SMI CIN IG AB SETTINGS i 44 5 12 SETTING THE VOLUME AND TYPE OF ALARM MELOLDY 45 i Bra dg Pme 46 Hi and low air temperature alatis lb sh peste thao E Et rete Ete be Mets 48 5 13 2 Hi and low skin temperature alarms SKI en Ono reno te ne Res 48 5 13 3 Hi and low relative humidity alarms sss sss n 49 5 134 Hand low Oxy een concentration alarms u uideat 49 5 14 Bed height adjustment only in height adjustable version 49 O6 INCUBATORASSEMDJISY ZL uu 50 Db APPS 50 e 51 6o MICRO TILTP 53 O ACONTROLC PANE 53 65 DETECTING PROBES GROUP ASSEMBLY u uu u Eb tei bem m stb aq bc aiu es 54 606 S Y STEM TET 55 CONNECTIONS FOR OUTSIDE CABLES uuu l uma sau 56 TAC CDS SORTIES 57 7 1 IN
32. Steam the hu midity comes from the evaporation of _ some drops of water which come from 6 outside in this version the water reser voir is exclusively used to only hold components to create according to the necessity the sterile vapour necessary inside the environment of the incubator The complex consists of 1 Peristaltic Pump to take in and measure out the droplets of water in the evaporator 2 Connecting wire to the control panel 3 Connecting wire for the evaporator heater with a right angle connector 4 Evaporator 5 Support for water supply tube 6 External water reservoir container it is located on the outside of the incubator 7 Tube in silastic calibrated to carry the water from the external water reservoir to the to the droplet maker of the evaporator 8 passing through the peristaltic pump 1 8 Connector for the Evaporator s water droplet maker Ginevri s r 8070bmd 01 03 2010 55 11 PolyTrend User manual 6 8 CONNECTIONS FOR OUTSIDE CABLES RIGHT SIDE VIEW OF THE CONTROL PANEL 1 Probe Assembly Connector and connecting cable to the probe group 2 Servo Steam Connector and connecting ca ble to the Servo Steam humidifier 3 Oxygen Inlet Connector connecting the incu bator to the medical oxygen supply 4 Oxygen to the Head box Connector and connecting tube to the Head box for oxygen therapy 5 Hot Spot Connector for connection to sup plementary radiant heat
33. TEGRATED BILLA SCALES 12030A70 OPTIONAL 60 EDER SENE aaa 60 EUM EPI ae 60 DOSGEIDUON 61 TA L Preparattomnolf theseales esa uu 62 Ti BES T Em 62 Th On ASE UMC ONS uy ET T SERE PI 63 BEI 63 7 1 8 Description of the Scale Display Screen of the PolyTrend Incubator 64 KLODE Of MINA GES CLI OMS 64 Jd L0 Advanced T tion 65 Visualization ot weicht varaton u u E 66 7 1 12 Visualizatiom of tie scales inclination u u 66 debo L LOU mene ae EEE EE 66 7 2 PULSE OXYMETER 11459A70 OPTIONAL 67 7 3 HOT SPOT RADIANT 7533 68 8 SPARE PARIS AND CONSUMABLES
34. TEMPERATURE HOOD INTERNAL NOISE LEVEL VENTILATION OGB PolyTrend User manual A Single moulded polycarbonate 220v 50 60 hz of injection 430w 570w with hot spot 15 IB 70 uA 2 Fuses 5x20mm 3 15Amp Included complete with internal rechargeable accumulator 0 1 C Resolution 0 6 C Maximum Error 0 1 C Resolution 0 3 C Maximum Error 1 Resolution 1 Resolution optional 1 Resolution 10 Maximum Error From 20 C to 39 C AIR from 25 C to 39 C SKIN Audio visual Alarm automatically deactivates the heating when internal hood temperature is higher than 38 C From 10 to 90 From 21 C to 26 C From 35 to 90 From 10 C to 50 C Less than 45dB 36 Lt min multi directional MAXIMUM CO2 CONCENTRATION MEASURED lt 1 per 1000 WITH TESTS DEFINED IN IEC 601 2 19 CEI 62 22 MAXIMUM CARRYING CAPACITY THE 10kg PATIENT BED DIMENSIONS INCUBATOR t nn ne ex ELO 2 eese HEIGHT FIXED TROLLEY 11400 70 HEIGHT ADJUSTABLE TROLLEY 11410A70 WEIGHT INCUBATOR uuu u uuu a u uu u HEIGHT FIXED TROLLEY 11400 70 HEIGHT ADJUSTABLE TROLLEY 11410A70 8070bmd 01 03 2010 83x65x69 cm W D H approx 89x73x72 cm W D H approx 89x73x72 cm W D H approx 3 kg approx 41 kg approx 55 kg approx Ginevri s r l
35. TICULAR IMQ REQUIREMENTS FOR MEDICAL DEVICES 0051 80 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual 11 15 AND SIGNAL PORTS There are entry or exit signal ports Ginevri s r l 8070bmd 01 03 2010 81 11 PolyTrend User manual 16 CLEANING AND STERILIZATION OF THE PARTS IN CONTACT WITH THE PATIENT MICRO FILTER The micro filter has a filtering capacity of less than 5 It is recommended to change it regularly and in any case it is good practice to change it for every patient Do not try to clean wash or sterilize the micro filter to re use it WARNING A dirty micro filter means e Contamination of the air around the incubator Limitation of the quantity of air in circulation e Limitation of the oxygen concentration Increase in carbon dioxide Before installing a new micro filter clean the filter holder assembly N B Ginevri does not assume any responsibility for any eventual malfunctioning of the apparatus or damage to individuals or objects which result from the use of another type of micro filter CLEANING AND STERILIZATION All OGB PolyTrend components can be easily dismantled by hand for maintenance cleaning and sterilization without the need for additional tools REBRIL p n 1711 is the cleaning detergent which we recommend and can be used to clean any component A special alkaline solution can s
36. Trend User manual 9 OPERATION The external ambient air enriched with oxygen if there is the need enters into the incubator by passing through a high capacity micro filter less than 0 5 um located on the base A special fan sucks in the air from outside with oxygen if necessary it pushes into the heating chamber and after that to be passed through the flow through the specially provided slits the patient tray and the side holding bars Through the specially designed slits of the patient basin and the side vent bars into the hood without creating damaging turbulence around the newborn The circulation system forced by the internal micro climate of the cockpit guarantees a constant air exchange 36 l min The light Venturi effect which is created in the four sides of the hood near the centre of the hood guarantees in addition to the elimination of the silent and uniform distribution of the micro climate around the newborn ATTENTION Check that the specially provided slits the patient tray and the side holding are not ob structed because in that condition an inadequate air circulation will result with the consequent increase level Keep the airway channels inside the incubator UNOBSTRUCTED which guarantees not only uniform air circulation but consequently also temperature uniformity 16 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual 11 5 1 CONTROL P
37. after a few seconds P gt N oxygen concentration can be varied step increments of 1 To limit the flow and for other safety reasons the maximum oxygen concentration obtain able inside the hood is limited to 65 while in the head box micro climate you can select and achieve values up to 99 The selected oxygen concentration value is memorized in the hard disk and will be saved even in the case of power failure OXYGEN INLETS The PolyTrend 15 also equipped with two inlets for the administration of pure oxygen e One limits the oxygen concentration inside the hood to 31 e The other limits the oxygen concentration inside the hood to 52 Both inlets are positioned on the front part of the filter holder WARNING When oxygen 15 administered it is important to use an oxygen concentration analyser or a pulse oxymeter Ginevri s r l 8070bmd 01 03 2010 39 11 OGB PolyTrend User manual OXYGEN CONCENTRATION INLET TABLE 31 Measurements taken with a flux metre connected to the 31 inlet Rate of Flow Oxygen Concentration lpm 1 22 7 p m 2 23 7 25 1 p m 5 29 p m 6 29 7 p m 7 30 3 8 31 p m 9 31 5 l p m 10 31 5 OXYGEN CONCENTRATION INLET TABLE 52 Measurements taken with a flux metre connected to the 52 inlet Rate of Flow Oxygen Concentration 40 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual Rev 11 5
38. ameters and to move between the various dis play screens 10 Probe connectors for the probe assembly of the Servo Steam and for the oxygen supply positioned on the right side of the control panel 11 AIR SKIN button with two LED lamps which when pressed permits the change of the size which is being thermo regulated with the consequent lighting of the LED in the selection area 12 Digital Trend Button when pressed permits the instantaneous transfer from the Numerical Data screen to the Temperature Trend screen Ginevri s r 8070bmd 01 03 2010 17 11 OGB PolyTrend User manual 5 2 MANAGEMENT OF THE DIFFERENT VISUAL DISPLAYS Incubator 15 managed by using and setting different visual display screens From the initial numeric data display screen which shows the data readings it is possible to access all the other displays using the Display Menu To access the display screens after the numeric data display proceed as follows l 2 3 4 5 Press the Block button 8 if the encoder is blocked with the corresponding LED switching off Turn the encoder until the menu field on the numeric data screen 1s selected Press the encoder to activate the Menu Display A list of the new displays available will be shown Turn the encoder to select the desired display screen The selected field will flash Press the encoder to access the desired display screen The display screen selection procedure 15
39. and come into function when the humidity inside the hood goes above or falls below the selected level by 1096 The alarms be muted by pressing on the MUTE 3 key in this state the red LED corresponding to the alarm 4 will flash until the humidity level goes back to the normal level If the alarm condition lasts for more than 10 minutes the alarm sounding will be automatically reset 5 13 4 H1 and low oxygen concentration alarms The HI and LOW Oxygen Concentration Alarms can be set either automatically or manu ally For Automatic setting you simply need to input the concentration level you want to reach set the alarms come into function when the oxygen concentration reading is differ ent by 10 from the selected level To Manual Setting proceed as follows 1 Press the Block button 8 if the encoder is blocked with the corre sponding LED then turning off 2 Rotate the encoder until the MAX or MIN level the oxygen field is selected 3 Press the encoder to activate the setting 4 Rotate clockwise direction to increase the MAX limit or the MIN limit and anti clockwise to decrease those values 5 Press the encoder to terminate the operation otherwise the operation Will be automatically terminated after a few seconds The alarms come into operation when the oxygen concentration reading goes above the selected MAX level or less than the selected MIN level The alarms be muted by pressing on
40. and precision temperature regulation of the internal incubator hood temperature in order that the patient is warmed to and kept at the pre selected patient skin temperature e To keep the temperature always under control with pre fixed high and low temperature alarms e Maintenance of a truly uniform internal hood temperature e To evaluate when it 1s possible to terminate the newborn baby s stay inside the incubator As when absence of heating the heating element 15 turned off The internal hood temperature 15 equal to the ambient temperature The patient s temperature is at the pre determined level Indicating that the newborn is self sufficient for maintaining its own body temperature The oxygen servo control system when needed allows the direct connection of the incubator to medical oxygen valves both central supply system or bottle supply to select and maintain concentrations from 21 to 65 inside the hood and up to 100 in a head box micro climate Ginevri s r l 8070bmd 01 03 2010 13 11 OGB PolyTrend User manual Thanks to the use of a special control algorithm the concentration is maintained constant at the desired level even with the opening of the hood access ports or with small variable loses over time The OGB PolyTrend Incubator is equipped with the Servo Steam Humidifier when requested With the Servo Steam it is possible to select and servo control the internal humidity level inside the hood up
41. asuring instrument and therefore it is necessari to adopt a se ries of small precautions to be able to make maximum use of its sophisticated character istics The scales maximum weight is 10 kg loads higher than this can damage it Keep the weight tray flat and free to move Tubes covers and other accessories must totally rest on the patient tray Always zero the scales before placing the baby on the scales otherwise the scales will show the weight of everything resting on the tray e After verifying an error it could be necessary to RESET the system To do this turn off and disconnect the scales plug from the sensor probe assembly and re connect it af ter making sure that the scales are flat and do not have any weight on them 60 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual 11 7 1 3 Description The Electronic Scale 15 made up of a single piece described below to be used it must be con nected to a Ginevri PolyTrend incubator Tray Mattress 3 Connection for the central unit ATTENTION To avoid irreparably damaging the weighing unit you must absolutely avoid the following condi tions presence on the tray of a total weight higher than 10 kg let the power cells go to a negative charge For example moving the unit by holding it by the baby holder tray 1 4 1 instead of by the flat aluminium bottom where the feet supports are fixed Before turning
42. at sources such as phototherapy lamps sunlight radiators etc 5 13 2 H1 and low skin temperature alarms skin The HI and LOW SKIN TEMPERATURE Alarms are automatically set when the desired SKIN TEMPERATURE level to be reached is selected They come into function when the temperature goes above HIGH TEMP or goes below LOW TEMP the selected value by 1 C The alarms be muted by pressing on the MUTE 3 key in this state the red LED corresponding to the alarm 4 will flash until the temperature level goes back to the nor mal level If the alarm condition lasts for more than 10 minutes the alarm sounding will be automatically reset In SKIN Mode if the patient sensor probe is correctly positioned the thermo regulation system will automatically limit the air temperature to 39 In this mode an accurate and rapid heating of the patient is obtained without the air tem perature inside the hood going above the allowed limits before the patient reaches the selected skin temperature In any case if the air temperature goes above 39 C the HIGH TEMP alarm will activate in a non mutable way until the air temperature is re set to a level less than 39 in this case the incubator heating will be stopped 48 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual 11 5 13 3 Hi and low relative humidity alarms The and LOW RELATIVE HUMIDITY Alarms are automatically set when the humidity level is selected
43. by pressing thee Mute button The alarm is deactivated if the sensor probe is disconnected A new calibration cannot be done until the sensor probe has been substituted with a new one e PRE HEATING Indication that the incubator is still in its warm up phase for the mutable alarms the acoustic alarms are inhibited The maximum duration of this alarm is 25 minutes and it is cancelled if the temperature reading is 0 9 C lower than the set temperature This indicator is activated only if on turning the incubator on the air temperature is lower than 28 High SpO2 MAX SpO2 alarm indicates an oxygen percentage in the blood above the selected limit e Low SpO2 MIN 5 2 alarm indicates an oxygen percentage in the blood below the selected limit High Pulse Rate MAX Pulse Rate alarm indicates a cardiac frequency a bove the selected limit e Low Pulse Rate MIN Pulse Rate alarm indicates a cardiac frequency be low the selected limit e SPO2 sensor incorrect positioning of the sensor probe and the lack of con nection will be indicated in the area reserved for alarms The red LED Alarm warning comes on at the same time as the acoustic warnings of the above mentioned alarms In the case of more than one alarm being acti vated simultaneously the number of alarms will be shown as well as the type of alarms description will be alternately shown Ginevri s r l 8070bmd 01 03 2010 47 11 PolyTrend User manua
44. calibration the writing OXY PROBE DISCHARGED appears it means that the oxygen sensor probe is depleted It will not be possible to carry out a new calibration until this is substituted with a new sensor probe The Oxygen Trend diagram including the oxygen graphic on the axis of that graphic is shown the selected temperature while on the frame the oxygen level is shown On the right of the screen there is a frame which shows the fundamental parameters monitored in real time 36 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual Rev 11 OXYGEN TREND DISPLAY SCREEN FIGURE OXYGEN TREND DISPLAY SCREEN e ALARMS area reserved for description of the activated alarms in the upper part of the display replacing the GINEVRI name air internal air temperature of the hood skin1 patient skin temperature check skin2 patient skin temperature peripheral S1 a active area to visualise the Temperature Trends taken from the difference between the SKIN and AIR sensor probes readings 51 52 active area to visualise the Temperature Trends taken from the differ ence between the SKIN sensor probe and the PERIPHERAL sensor probe readings 3h 6h 12h 24 48h 7gg active area to visualise the relative Trends The Oxygen Trend display graphs the oxygen trend taken from the dedicated sensor probe On the base axis of each graph is shown the time while on the vertical axis the reported oxygen level values are
45. ce of a constant skin temperature pre set of the newborn even with both of the incubator s door panels open INSTALLATION AND FUNCTIONING To install the HOT SPOT on the hood work as follows Remove the plastic angle cover of the hood unscrewing the two rounded chrome fixing bolts Insert the HOT SPOT in place of the before mentioned cover previously taken out and attach it with the previously mentioned bolts Make sure by using the specially provided clips that the connection cable is connected to the incuba tor s control panel Unscrew the screw cap of the Hot Spot plug located under the right angle of the control panel Insert the connector wire into the plug indicated above and screw in the fixing ring nut to the connector itself Affix the Hot Spot Control Module onto the specially designed support attached to the front right leg of the trolley Press the On switch of the Control Module to turn the HOT SPOT on WARNINGS The Hot Spot turns on Only when the Poly Trend is operating in Skin Mode Control Only when the oxygen concentration the hood is at 21 Therefore the oxygen concentration sensor probe Which gives permission for the activation of the radiant heat must e Have been calibrated see page 20 e Be inserted into the appropriate support inside the hood e Show an oxygen concentration reading less than 22 The operations described above must be followed to have the permission to turn o
46. d by the operators and periodical maintenance 11 1 ELECTRICAL SAFETY PARAMETERS CHECK Carry out a dispersion and isolation test every year 72 8070 01 03 2010 Ginevri s r l OGB PolyTrend User manual 11 11 2 METHOD USE FUNCTIONING AND MAINTENANCE e Insert the water reservoir used inside the Servo Steam humidifier into the appropriate location space found on the base bottom Inserire la vaschetta contenente il sistema di umidificazione Servo Steam nell apposito vano posto sul retro del basamento Connect the water reservoir to the incubator s control panel with the connecting wire 2 This wire must be connected to the connector found on the right side of the control panel and labelled Servo steam Insert the water container in its holder fixed to the trolley and connect the water supply tube 7 e Connect the silastic tube 7 to the droplet maker 8 passing the previously mentioned silastic tube 7 through the peristaltic pump and support 5 In order to prevent the formation of calcium deposits in the evaporation chamber we suggest the use of distilled water However it is still important to check the heating chamber of the evaporator 4 at least every week if you use normal water So to verify the condition of the heating chamber itself for the formation of chalk This can be eliminated melted with a bit of VIAKAL or with a liquid made for that purpose To take the evaporator out 4 you only
47. e OGB PolyTrend relation to possible electro magnetic interference in accordance with the current Standards Ginevri 6 1 1 8070bmd 01 03 2010 75 11 PolyTrend User manual 13 LABEL TAG AND WARNINGS Equipment Identification Label cod 11523A25 TECNOLOGIE BIOMEDICHE S N Manufactured by GINEVRI srl Series bators GINEVRE m we CC REY AN Registered Office Via Giacomo Bani 15 00162 ROMA ITALY Model OGB Polytrend 50 51 Manufacturing Plant Via Cancelliera 25 B 0004 1 CECCHINA Roma ITALY Fuses 3 15 A F Classi B tel 3906934591 fax 4390693459393 www ginevri cam 230 V AC 50 60 Hz 2 1 A 430 W Control Panel OGB poly trend cod 11876A206 Left side panel label code 10663A25 Bury Right Side panel label code 10664A25 ASSEMBLY STEAM peur PF GXYGEN TO THE HOT SPOT HEADED 76 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual Rev 11 Oxygen sensor label code 10268A25 GINOURI SENSORE OSSIGENO P N 10267A30 ATTENZIONE contiene liquido caustico Una fuoriuscita di liquido pu causare lesioni alla pelle In caso di contatto lavare per 15 minuti con acqua qualora vengano interessati gli occhi ricorrere al consiglio medico WARNING sealed unit contains caustic Causes severe burns Can be fatal if swallowed Oxygen Calibration support label on the trolley code 118
48. e base AIR CONVEYOR 50 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual Rev 11 Side bars with vent slits close the hood Connect them internally to the base closing them with the rounded chrome bolts provided Do not screw the above mentioned knobs in until the footings of the incubator hood have been put into place After that tighten them down making sure that the two knobs sticking out from the sidebars enter to the correspond ing holes in the hood 6 2 HOOD To mount the hood onto the base lift it with the palms of the hands as shown in the figure and put into place on the base so that the sidebar base gaps match up and correspond To put the patient bed tray into the incubator do as follows Lower the Smooth Tilt arms completely rotat ing the provided blue handles located on the sides of the base left and right Insert the patient tray inclin ing as shown 1 in the figure making sure it is put in towards the end with FRONT written on it To take it out simply do the opposite Ginevri s r l 8070bmd 01 03 2010 51 11 OGB PolyTrend User manual To disassemble the doors loose both the screws and slide the hinge out Both the doors should be kept close during routine operation For infant safety do not leave the infant unattended while the doors are open WARNING Closing the doors check that the bottom side of the door is inserted in the base slot as shown in
49. encoder must be kept pressed When the set temperature is gt 37 C on the display a flashing gt 37 indicator 1 will appear The temperature value selected is memorized in the hard memory and is maintained even in case of loss of power 26 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual 11 If during thermo regulation in SKIN mode the sensor becomes disconnected the SKIN PROBE DISCONNECTED alarm will activate and the temperature will automatically be regu lated in AIR mode to an initial setting of 33 During thermo regulation in AIR mode however it is possible to disconnect the SKINI sensor probe with activating any alarms Position the thermo metric sensor probe for reading the skin temperature in contact with the baby s skin at the level of the abdomen precisely between the belly button and the abdomen itself For a true and safe attachment we recommend the use of our probe fix gel P N 565 The thermo metric sensor probe for reading skin temperature must not be used as a rectal sensor except 1f 1t has been deliberately pre prepared for that use Ginevri s r l 8070bmd 01 03 2010 27 11 PolyTrend User manual WORKING DIAGRAM FLOW CHART OF THERMO REGULATION IN SKIN MODE Analogue safety system AIR TEMPERATURE gt 40 C Heating OFF Alarm cannot be FAN FAILURE ALARM ACTIVATE THE CIRCULATION TURNING silenced
50. h not only allows the maintenance of a constant skin temperature of the patient even with the incubator doors open but also makes superfluous the use of a double hood and or a thermal hot air barrier 12 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual 11 4 1 INTRODUTION OGB PolyTrend Incubator with its micro processor control system can work to control the heating level of both the air inside the incubator hood as well as the baby s temperature Thanks to a proportional heating system the heat supplied varies directly in conjunction with the requested requirements This system allows for the newborn baby s skin temperature to be stabilized with very small variations of the incubator internal temperature The diagram shows the various individual parts of the OGB PolyTrend supported on a wheeled cabinet Hood Porthole with sleeve and door Fire retardant mattress Patient tray equipped with a tilting bed system for the Trendelemburg and Fowler positions 5 Sidebar with vent slits 6 Base 7 Control Panel 8 9 1 De Et Air filters to less than 0 5micron Polycarbonate Humidifier reservoir 0 Top part of the humidifier the above listed components are made of pressure fusion polycarbonate The PolyTrend Incubator requires an electrical supply of 220V 50 60Hz 430W 570W with Hot Spot The proportional thermo regulation system allows e Automatic
51. h or sterilise the micro filter in order to re use it WARNING dirty micro filter means e Contamination of the air in the interior of the incubator e Limitation of the quantity of air in circulation e Limitation of the oxygen concentration e Increase in carbon dioxide Before installing a new micro filter clean the filter holder assembly N B Ginevri does not assume any responsibility for eventual malfunctions of the apparatus or damage to persons and or equipment deriving from the use of other types of micro filter 11 4 SENSOR SUBSTITUTION The oxygen sensor 4 which is galvanic cell battery therefore has a limited life even if it is not utilized Even if stored the duration lifespan is not unlimited it is therefore advised to limit the time kept in storage to the minimum abso lutely necessary To substitute the sensor e Dismantle the sensor holder by unscrew ing the two screws 1 e Disconnect the connector 5 6 5 Loosen sensor holding screw 2 e extract the sensor 4 and substitute it 6 with a new one The duration lifespan of the sensor which generally lasts for many months varies with the variation of the oxygen concentration readings taken the higher the concentration the less the duration 74 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual 11 12 ELECTRO MAGNETIC INTERFERENCE AND OTHER INTERFERENCE safety measures have been adopted for th
52. h the prepared solution of detergent sterilizer The duration of this operation will be regulated by necessity keeping in mind that the slower and more thorough the washing the more efficient the combined actions of cleaning and sanitizer will be e Rinse very well with lots of normal temperature water To get the best result carefully follow the instructions above doing the washing with a very soft cloth or with a sponge or with a shammy cloth and in particular when treating the transparent surfaces like the hood the humidifier etc ATTENTION Whatever your intention to use other detergents different from Our REBRIL remember that solutions containing Surface active clorexedina lauryl oxide and whatever else useful for washing and disinfecting the hands can cause irreversible damage to the Polycarbonate Lexan parts of the incubator and to the patients Therefore exclusively use detergent agents known for their compatibility with polycarbonate Lexan Ginevri s r l 8070bmd 01 03 2010 83 11 OGB PolyTrend User manual PROBLEMS ENCOUNTERED POSSIBILE CAUSES SOLUTIONS Lack of power supply Alarm not active Lack of Power Supply Alarm is active TEMP Alarm is active Fan Failure Alarm is activated LOW TEMP Alarm is activated Skin probe sensor alarm is ac tivated PROBE CABLE DISCONNECTED Alarm is ac tivated Low humidity percentage Low oxygen percentage OXY PROBE DISCONNE
53. it 1s possibile to use the STORE command to memorize the weight of items of interest to be memorized WARNING To effect the ZERO the weight needs to be stable and the work LOCKED needs to be present under the word WEIGHT In addition the scales must be flat and no inclination must be displayed on the video on the scales If the inclination indicates that it is not calibrated carry out the incline meter s calibration which 1s explained later in this manual 64 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual 11 STORE COMMAND The electronic scales is equipped with memory which permits the registration of the meas ured level readings and to put them into correlation with successive value readings In this way it is possibile to see increases and decreases in the newborn s weight with respect to the base memorized weight being able to rapidly return to the current reading display Select the STORE frame using the encoder and press the encoder to memorize the weight shown in the WEIGHT frame This command can be used to memorie the weights of things of interest to be memorized for ex ample before the newborn s first feeling to be able to read the DELTA frame the difference be tween the actual reading and that previously memorized THE gr Ib COMMAND Selecting the gr Ib command using the encoder and pressing the encoder changes measure ment unit used on the scales display The means that it 1s possib
54. l 5 13 1 Hi and low air temperature alarms air The HI and LOW AIR TEMPERATURE Alarms are automatically set when the desired AIR TEMPERATURE level to be reached is selected They come into function when the temperature goes above by 1 C HIGH TEMP or goes below by 3 C LOW TEMP The alarms be muted by pressing on the MUTE 3 key in this state the red LED corresponding to the alarm 4 will flash until the temperature level goes back to the nor mal level If the alarm condition lasts for more than 10 minutes the alarm sounding will be automatically reset A TEMP alarm is present controlled by an protection analogue circuit independent from the micro processor which is activated when the air temperature inside the incubator hood reaches 40 or the heating element reaches too high of a level The MAX TEMP alarm is controlled by an protection analogue circuit independent from the micro processor which is activated when the air temperature inside the incubator hood reaches 40 C In this condition the heating will be suspended and the alarm will sound and cannot be silenced The incubator will be switched off and the high air tem perature diminishes In any case if the air temperature goes above 39 C the HIGH TEMP alarm will acti vate in a non mutable way until the air temperature is re set to a level less than 39 in this case the incubator heating will be stopped These alarms are also sensitive to outside he
55. le Display Screen of the PolyTrend Incubator The Scales Display Screen on the display will appear as in the figure The display screen 15 made up of the following frames with the words WEIGHT DELTA STORE and command panels in the bottom of the display ZERO STORE gr Ib RETURN WEIGHT The current weight will be shown in the upper frame next to the word WEIGHT If in the weight level reading window dashes appear this indicates that there are problems due to the connection between the weighing unit and the incubator s sensor probe assembly or there is a malfunciton In this event contact technical service assistance The writing LOCKED under the writing WEIGHT indicates that the scales have been calibrated and that the current weight 15 correct When the weight changes by more than 5 grammes from the previous weight reading the scales will take a new weight reading and write dashes in the area under the word WEIGHT When the weight becomes stable again the work LOCKED will appear again DELTA In the DELTA frame the difference between the actual weight on the scales and weight the last memorized with the STORE command will be appear STORE In the STORE frame the last weight memorized using the STORE command will be shown 7 1 9 Command descriptions ZERO COMMAND selecting the ZERO field using the encoder and press the encoder to re define the zero of the plate use this command only when the plate 15 empty otherwise
56. le to see the weight in either grammes or pounds and ounces THE RETURN COMMAND Selecting the Return frame with the arrow using the encoder and pressing the encoder will transfer onto the incubator s principle display screen 7 1 10 Advanced Functions In addition to the normal functions of the scales previously described the Billa electronic scales 1s equipped with two important functions e Visualisation of the weight variation over time using the trends e Visualisation of inclination Ginevri s r l 8070bmd 01 03 2010 65 11 PolyTrend User manual 7 1 11 Visualization of weight variations The integration of the scales into the PolyTrend incubator permits sophisticated checks on the baby s weight variations during the baby recovery If you connect the scale to the incubator it will be possible to display the baby s weight of the last week This can help the physician to better evalute the growth of the baby To display the weight trend you have to select through the encoder the weight trend selection in the encoder the trend page as you can see at page 18 of this manual Once selected the following screen will appear It 1s possible to see the weight Trends of the last 3 6 12 24 48 hours or even to the last 7 days The time resolution used in the visualisation 1s the last one that has been set To change the time resolution turn the encoder to select the desired time interval and then press the encoder
57. lization of the number of machine s working hours 0 INCL Active area for zero ing of the incline meter of the scales see scales manual return return to the initial numeric data display screen 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual 11 5 12 SETTING THE VOLUME AND OF ALARM MELODY Ginevri s r l FIGURE ALARM SETTINGS DISPLAY SCREEN ALARMS area reserved for the description of the alarms which are active will appear in the upper area in place of the writing GINEVRI VOLUME SETTING indicates the volume setting for the alarms SELECTED MELODY indicates the melody selected return ritorno alla schermata dati numerici 8070bmd 01 03 2010 45 11 OGB PolyTrend User manual 5 13 ALARMS All the settings readings taken from the sensors are shown on the graphic mono chrome display in the centre of the Control Panel Different settings and visualizations are accessible by using the different displays available on the monitor The high part of the liquid crystal display is dedicated to visually displaying descriptions of the alarms e HIGH TEMPERATURE is seen when the air temperature inside the hood exceeds the set temperature by 1 or when the skin temperature exceeds the set tem perature by 1 C Otherwise there is an alarm controlled by the micro processor which is activated when the air temperature inside the incubator exceeds 39 5 This last ty
58. n the HOT SPOT An acoustic alarm will indicate that the system is active The alarm is self re setting and re actives automatically every 10 seconds Satisfying the precautions indicated above the HOT SPOT will automatically through the incubator s servo control give the newborn a healthy and pleasant heat bringing and maintaining the little patient s temperature to the pre set temperature level even with the two incubator door panels completely open 68 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual 8 SPARE PARTS AND CONSUMMABLES Ref Code Description Image 11130A72 FILTER AIR 434 MATTRESS SLEEVE FOR 11725A73 PORTHOLE THERMOMETRIC AL NEONATAL SENSOR PROBE BLUE 11730A73 PERIPHERAL NEONATAL SENSOR PROBE YELLOW 11730G73 GEL REFLECT 565 SENSOR PROBE FIXATIVE REBRIL DETERGENT POWDER Pack of 2 Kg RUBBER SEAL FOR DOORS WITH OVAL PORTHOLES RUBBER SEAL FOR THE HOOD ROUND OLES AJ 1711A 11721A73 12029A73 10 10267A73 OXYGEN SENSOR Ginevri s r 8070bmd 01 03 2010 Rev 11 Qty Pack of 12 Pack of 12 Pack of 6 Pack of 6 Pack of 24 Pack of 6 Pack of 6 69 11 OGB PolyTrend User manual 9 APPARATUS SPECIFIC FUNCTIONS AND APPLICATIONS The OGB POLYTREND incubator is an apparatus which has be studied designed and manufac tured to create and maintain the ideal micro climate necessary for newbor
59. need to disconnect the connecter supplied for that use at angle 3 pulling on it and extract the evaporator 4 towards the outside On the bottom of the evaporator the heating chamber is easily visible and it will show the formation of chalk as a white covering As the body of the evaporator 4 is made of teflon and is isolated from the heat it can therefore be touched during operation How ever the previously mentioned heating chamber which is made of metal and works at 135 C can not be touched before it has been able to cool down approx 30 minutes ATTENTION The Servo Steam is activated only when the temperature of the heating chamber evaporator is working properly i e 135 C A temperature which is reached in approximately 3 4 minutes and therefore to determine the time necessary for pre heating of the incubator it is enough to follow the time to reach working temperature of the heat ing chamber Connector for the evapora droplet 8 Internal wall disconnect to take out E Evaporator bw ire 22 or Wire connector to E evaporator heater control panel Ginevri s r 8070bmd 01 03 2010 73 11 PolyTrend User manual 11 3 MAINTENANCE MICRO FILTER micro filter has a filtering capacity of less than 5 um Frequent substitution is recommended and any case it is advisable to do it for every patient Do not try to clean was
60. ns and to allow for the widest and most complete range of medical assistance The device puts at the operator s disposition a series of functions designed to create and maintain the micro climate most adapted to the patient s clinical state The functions are the following 1 Air Thermo regulation air with a setting range between 20 C 37 and in special cases with particular programming between 37 C and 399 2 Skin Thermo regulation with a setting range between 25 37 C and in special cases with particular programming between 37 C and 39 C 3 Humidity Servo control with a setting range between 10 90 4 Oxygen Servo control with a setting range between 2196 6596 in the hood or 2195 909 when the oxygen output is limited only to the baby area head box 70 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual 11 10 THE APPARATUS Open hood folding the front door upwards Take the patient tray out operating as described page 13 for insertion Loosen the handle rounded chrome which holds the side vent panels and extract them Lift the hood from the base lifting 1t using the palms of the hands on the upper internal surfaces of the hood itself See photo page 13 Place the now removed hood onto a flat surface DUST REMOVAL Dust the hood with a clean soft cloth HEATING UNIT Disconnect the power supply of the heating unit before cleaning it The heating unit
61. od during the incubator pre heating phase To use the oxygen servo control connect the incubator to the oxygen supply system fol lowing the instructions supplied in the Incubator Assembly section If the oxygen therapy is to be carried out directly inside the hood position the sensor probe inside the hood itself If instead the head box micro climate is used then position the sensor probe in the provided holder located in the head box itself taking care that the hub on the sensor enters into the matching holder groove this operation activates the oxygen supply in the head box The sensor is always put vertically into place with the egress at the bottom in order to avoid the possible formation of condensation water drops which can fall onto the baffle and alter the readings To enable the servo control mode from the Numeric Data Display Screen set the O2 percentage in the range between 21 99 proceed as follows 38 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual 11 1 Press the Block button 8 if the encoder is blocked with the corresponding LED then turning off Rotate the encoder until the set value in the oxygen field is selected Press the encoder to activate the setting Rotate in a clockwise direction to increase the oxygen value setting and anti clockwise to decrease that value 5 Press the encoder to terminate the operation otherwise the operation will be automatically terminated
62. pe of alarm cannot be Muted LOW TEMPERATURE when the air temperature in hood is inferior of 3 C respecting to setting temperature or when the setting temperature is inferior of 1 respecting to sertting temperature e MAX TEMP is controlled by a protective analogue circuit independent from the micro processor and is activated at 40 e HIGH HUMIDITY when requested indicates the state of the alarm for high per centages of humidity and is activated when the level of humidity reading is 10 higher than the pre selected value e LOW HUMIDITY when requested indicates the state of the alarm for high per centages of humidity and is activated when the level of humidity reading is 10 lower than the pre selected value HIGH OXYGEN when requested indicates the state of the alarm for high oxygen concentration and is activated when the oxygen concentration reading is higher than the pre selected maximum value e LOW OXYGEN when requested indicates the state of the alarm for high oxygen concentration and is activated when the oxygen concentration reading is lower than the pre selected minimum value FAN FAILURE Blocked fan alarm is activated if the air circulation fan is blocked or slows down In this case both the visual and auditory alarms are activated not mutable and heating is suspended AIR PROBE FAILURE this alarm is activated for a broken air probe when the temperature difference between the air sensor p
63. r without using a micro climate cap can increase the internal noise level dB of the incubator e The temperature probe for taking the patient s skin temperature must be positioned in contact with the baby s skin onto the abdomen precisely between the belly button and the abdomen itself For a correct and secure attachment we recommend the use of our probe fixer gel P N 565 e The temperature probe for measuring skin temperature must not be used as a rectal sensor e Maximum attention must be given to make sure that other electrical equipment attached to the baby or positioned near the incubator conform to European Safety Standards and those relating to electromagnetic compatibility e ncorrect use of the incubator could be dangerous to the patient The incubator must only be u sed by properly personal trained and under the supervision of Doctors aware of the risks and benefits involved e Make sure that the electrical wiring of the power supply has been installed and is maintained to the level prescribed by the European Standards e Before putting the little patient the incubator make sure the incubator and its related ac cessories have been thoroughly cleaned disinfected and that the equipment is in good working order for this please see the Maintenance and Service Manual e When for whatever reason the control panel has to be taken out of the incubator base take maximum care with the resistance spiral because it could be hotter
64. robe and the test sensor located at the same place is greater than 1 C SKIN PROBE DISCONNECTED this alarm is activated when the Skin1 sensor probe becomes disconnected and the incubator is in Skin thermo regulation Mode in this case the thermo regulation passes to Air Mode with the temperature set at 33 e PROBE CABLE DISCONNECTED disconnected probe cable alarm is activated when the probe group wire is disconnected When this occurs heating and all of the machine s other functions are suspended OXY PROBE DISCONNECTED when requested the Disconnected Oxygen Sensor Probe Alarm is activated when the oxygen sensor probe is disconnected The alarm can be silenced by pressing the Mute button WRONG OXY PROBE POSITION when requested Alarm for the incorrect posi tioning of the oxygen sensor probe If it is activated not having done the calibra tion the sensor probe is positioned in the probe door in the hood or in the small 46 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual 11 Otherwise it is activated after having done the calibration if the oxygen probe is not in one the two reading positions to move the probe to a new position the user has approximately one minute before the alarm is activated DISCHARGED OXY PROBE when requested Discharged Sensor Probe A larm is activated when the oxygen sensor probe is discharged The alarm is both visible and acoustic and can only be silenced
65. ry graph has a vertical line showing the current time as well as on the graphs there is a horizontal line indicating the pre set temperature Ginevri s r 8070bmd 01 03 2010 25 11 PolyTrend User manual 5 4 THERMO REGULATION IN SKIN MODE SKIN MODE FIGURE SKIN MODE The OGB PolyTrend incubator allows for carrying out thermo regulation in SKIN Mode SKIN MODE setting values between 25 39 with 0 1 incremental steps To select the SKIN Mode function SKIN MODE press on the SKIN button 11 so that the corresponding LED on the Control Panel comes on while on the display the writing skin will appear in the position shown in the figure above SKIN MODE To set the temperature in the range 25 C 37 C proceed as follows 2 Press the Block button 8 if the encoder is blocked with the corresponding LED switching off 2 Turn the encoder to select the Tset value the value of Tset in fact will appear Press the encoder to activate the setting 7 Turn the encoder clockwise to increase the temperature setting and counter clockwise to decrease the temperature setting 8 Press the encoder to finish the operation otherwise the operation will shut itself off af ter several seconds gt The temperature can be changed with incremental steps of 0 1 C set the gt 37 C follow the same procedure with the difference that in the step between point 3 and point 4 the
66. shows the relative humidity range with respect to the positioning of the regulating control handle MINIMUM MEDIIUM MAXIMUM AMBIENT ROOM INCUBATOR INCUBATOR HUMIDITY TEMPERATURE HUMIDITY TEMP Minimum Medium Maximum 24 52 32 60 65 65 75 75 90 35 C 53 63 63 73 73 83 30 8070 01 03 2010 Ginevri s r l OGB PolyTrend User manual 11 5 6 SERVO REGULATION THE HUMIDITY LEVEL OGB PolyTrend incubator is equipped with a Ser vo Steam servo controlled humidifier With the Servo Steam it is possible to set and ser vo control the humidity level inside the incubator hood up to a value of 90 The humidity generation system guarantees the pro duction of sterile humidity inside the incubator be cause the evaporator located in the standard hu midifier housing is isolated from the environment re served for the patient and works at 135 C The water reservoir is located on the exterior of the incubator and therefore only vapour enters and diffuses into the patient space FIGURE Humidity visual display To set the humidity level between 15 90 proceed the following way 1 Press the Block button 8 if the encoder is blocked the corresponding LED will then turnoff 2 Rotate the encoder until the set value the humidity field is selected 3 Press the encoder to activate the setting Ginevri s r l 8070bmd 01 03 2010 31 11 PolyTrend User manual
67. t necessary to move the little patient from the incubator during this cleaning procedure Ginevri s r 8070bmd 01 03 2010 29 11 OGB PolyTrend User manual MODE OF USE MAINTENANCE AND OPERATION OF THE STANDARD HUMIDIFIER e Extract the water container from the base pressing on the two spring levers on the sides e Lift the cover blue e Clean and rinse out the transparent water container the cover made up of two half covers able to be dismantled and separated from each other and il deflector with its related control group These operations can all be carried out without the need for any utensils e Fill the transparent water container with drinkable or distilled water up to the level marked by a line e Replace the cover blue into place e Insert the filled water container into the base with just enough pressure to make the two blocking levers e Regulate the humidity to the desired level by using the specifically provided control handle Control cluster with handle for humidity level adjust ment Deflector In the hood more or less condensation depends upon the difference between the ambient temperature and that of the incubator In normal conditions for confinement to bed the humidity level is in the 50 65 range Whenever it is necessary to create a humidified oxygenated environment with elevated temperature it is recommended to use a head box micro climate The table shown below
68. t skin temperature check skin2 patient skin temperature peripheral S1 a active area to visualise the Temperature Trends taken from the difference between the SKIN and AIR sensor probes readings S1 S2 active area to visualise the Temperature Trends taken from the differ ence between the SKIN sensor probe and the PERIPHERAL sensor probe readings 3h 6h 12h 24 48h 7gg active area to visualise the relative Trends The humidity trend graphs the incubator s internal humidity level on the base axis of each graph is shown the time while on the vertical axis the reported humidity values are shown The first time on the left indicates the time the incubator was turned on Every graph has a vertical line showing the current time Ginevri s r l 8070bmd 01 03 2010 33 11 PolyTrend User manual 5 7 OXYGEN SERVO CONTROL AND MONITORING SYSTEM The OGB PolyTrend can be equipped upon request with an oxygen servo control and monitor ing system which allows the setting of values between 21 to 65 in the hood while in the micro climate head box from 21 to 99 this without alterations to the micro climate and with low flow supply The incubator is also equipped with an automatic recognition system of the oxygen supply in either the hood or the micro climate head box For safety reasons the maximum oxygen concentration attainable inside the hood has been limited to 65 while the head box it is possible
69. that holder for all the incubator s re heating phases and in any case for about 30 minutes with the incubator itself already working that is to avoid calibration errors and there fore measurements because of differences between the ambient temperature 21 C 26 and the working temperature 31 C 36 e Take the sensor from the interior of the hood or micro climate head box and insert it in to the provided sensor holder located outside the hood precisely on the back left side of the trolley in the area protected by the handles see page 11 where an oxygen concentration of 21 is certain activate the calibration process which does not take Re introduce the sensor probe into the sensor holder inside the hood or micro climate head box Ginevri s r l 8070bmd 01 03 2010 35 11 PolyTrend User manual The PolyTrend incubator can be quipped with an oxygen concentration servo control and monitoring system with allows for the setting of levels between 21 to 65 in the hood while in micro climate head box from 21 to 99 this without alterations to the micro climate and with low flow oxygen supply The incubator is also equipped with an automatic recognition system of the oxy gen supply in either the hood or the micro climate head box For safety reasons the maximum oxygen concentration attainable inside the hood has been limited to 65 while the head box it is possible to set values up to 99 Vo
70. the MUTE 3 key in this state the red LED corresponding to the alarm 4 will flash until the oxygen concentration level goes back within the desired limits If the alarm condition lasts for more than 10 minutes the alarm sounding will be automatically reset 5 14 Bed height adjustment only in height adjustable version To the incubator s height you only need to press on the activator pedal on the base of the OGB POLYTREND Especially there are two pedals the pedal with the up arrow raises the incubator the pedal with the down arrow brings down the incubator Ginevri s r l 8070bmd 01 03 2010 49 11 PolyTrend User manual 6 INCUBATOR ASSEMBLY All the PolyTrend incubators have been designed to simplify and make more efficient main tenance cleaning and sterilization procedures the incubators components are easily taken apart in just a few minutes and without needing any tools All the electrical power components are contained in the control panel and are easily removable 6 1 BASE A system of attachment points has been designed to securely fix the incubator to the trolley Place the incubator on the specially design trolley top such way that the feet of the base itself go into the specially provided foot ings in the trolley top and connect the 4 screw bolts to hold every thing together trolley and incubator Insert into the fixing points specially provided in th
71. the same for the selection of any of the other display screens as for example the Trend Display or the Settings Display from which new setting functions can be accessed The procedure to follow will always be the same as that listed above 18 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual Rev 11 NUMERIC DATA DISPLAY SCREEN 32 1 ET 8 st 32 0 Teun 3 1 7 Os Mon SET FIGURE DATA DISPLAY SCREEN Tair incubator internal air temperature Tskin1 patient skin temperature to check Tskin2 patient skin temperature peripheral Tset pre set temperature for air or skin thermo regulation heating percentage Numeric value and bar graphic HUMIDITY humidity percentage reading inside the hood SET pre set humidity percentage OXYGEN oxygen percentage SET pre set oxygen percentage MAX maximum limit for oxygen percentage without alarm activation minimum limit for oxygen percentage without alarm activation WEIGHT weight in grams SPO2 blood oxygen percentage level MENU area used to activate the Menu display gt 37 C when the pre set temperature is greater than 37 24095 when the pre set oxygen level is greater than 40 ALARMS area reserved for the description of activated alarms which will appear in the upper area of the screen in place of the GINEVRI name Ginevri s r 8070bmd 01 03 2010 19 11
72. the scales on make sure that the two safety screws located on the underside have been removed See paragraph 2 1 Ginevri s r 8070bmd 01 03 2010 61 11 PolyTrend User manual 7 1 4 Preparation of the Scales Take the scales out of their packing ca se Completely unscrew the two screw found under the Weighing Unit 2 1 1 which safeguard the sophisticated Load Cells during transport Place the safety screws with the packing case and keep them for any future transport and or move managing the weighing unit always hold it by the aluminium under side D This precaution is necessary to avoid any possible damage to the Cell Posi Vista dal basso dell Unit di Pesatura tion of the Weighing Unit flat inside the incubator or where it 1s required to use the apparatus and make sure that the baby carrying tray is free to move if not the weight measurements taken will be affected by errors Follow the operations described above connect the weighing unit and the incubators sensor probe assembly as in the Figure Scales Connector 7 1 5 Switching On Remove all superfluous weight from the scales plate and turn the incubator on During the switch on phase the scales calibration will be carried out In this phase in the scales display a zero weight and some dashes under the writing WEIGHT will be shown When the cali bration is finished the writing LOCKED will appear under the
73. to a value of 100 The humidity generation systems guarantees e Absolute sterility because the vaporizer connected to the compartment of the standard humidifier is isolated from the patient environment and works at 135 C e water reservoir is placed on the exterior of the incubator e Only vapour enters and is diffused into the patient ambient 4 2 TECNOLOGY AND MATERIALS What distinguishes the new generation of Incubators 1s the choice of materials and the new tech nologies used in their development and design The hood the base the command panel the humidifier the Smooth Tilt the patient basin as well as other minor components are all made of polycarbonate lexan using one piece hot pres sure injection system moulds The sum total of the design the shapes the materials used and how they are made 15 one of the many characteristics which distinguish the OGB PolyTrend incubators making them unique on the world market In fact no other make of equipment exists that offers simultaneously all these innovative functions The single piece stamping of the polycarbonate components the rounded corners and the ab sence of glued joints improves the air circulation reduces internal noise and allows for very thor ough cleaning thus guaranteeing maximum reliability and performance from every point of View The technology used in the OGB PolyTrend makes repair and maintenance operations both sim ple and economic From
74. to set values up to 99 tm To use the servo control you need to connect the PR incubator to the hospital oxygen supply system or to an oxygen tank The incubator can be con nected directly to the supply source and does not require reducers or external pressure regulators The connecting tube suitable for the supply pres sure must be connected to the inlet 1 located on the right side of the control panel and labelled with OXYGEN INLET _ The micro climate head box supply tube at low CL pressure must be connected to the inlet 2 lo cated on the right side of the control panel and la belled with OXYGEN TO THE HEAD BOX The oxygen sensor probe connector is connected in the specially provided inlet OXY PROBE located on the left side of the control panel To carry out calibration you need to insert the sensor in the holder provided see the section regarding the calibration operation page 34 34 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual Rev 11 Position the sensor inside the hood or inside the mi cro climate head box the incubator will automati cally select the oxygen supply operating mode ei ther hood or micro climate head box WARNING To obtain an optimal calibration of the oxygen concentration sensor you need to act as follows e Introduce the sensor into the specially provided holder located inside the incubator hood or in side the micro climate head box e Keep it in
75. ton 11 so that the corresponding LED on the Control Panel comes on while on the display the writing will appear the position shown in the figure above AIR MODE To set the temperature in the range 20 C 37 C proceed as follows 1 Press the Block button 8 if the encoder is blocked with the corresponding LED switching off 2 Turn the encoder to select the Tset value the value of Tset in fact will appear 3 Press the encoder to activate the setting 4 Turn the encoder clockwise to increase the temperature setting and counter clockwise to decrease the temperature setting 5 Press the encoder to finish the operation otherwise the operation will shut itself off af ter several seconds The temperature be changed with incremental steps of 0 1 C To set the gt 379 follow the same procedure with the difference that 1n the step between point 3 and point 4 the encoder must be kept pressed When the set temperature is gt 37 C on the display a flashing gt 37 indicator 1 will appear The temperature value selected is memorized in the hard memory and is maintained even in case of loss of power When the temperature selected is modified the Function Mode in use AIR or SKIN will also be memorized in the hard disk Ginevri s r 8070bmd 01 03 2010 23 11 PolyTrend User manual WORKING DIAGRAM FLOW CHART OF THERMO REGULATION IN AIR MODE istema di sicurezza analogico
76. top the build up of calcium deposits without corroding the plastic or metal materials The components are not dangerous for the operators Do not use cleaning substances which are abrasive or strongly alkaline Do not scrape the surface with glass cleaning rubbers blades razors or other sharp utensils Do not clean the incubator when it is hot DISMANTLING Open upwards the front door of the hood Take the patient tray out as described in page 13 to insert it Loosen the bolts rounded and chrome plated which hold the side holding bars and take it out Lift the hood from the base lift it with the palms of the hands placed on the interior walls of the hood itself see photo pg 13 Set the removed hood onto a flat surface DUST REMOVAL Dust the hood with a soft clean cloth HEATING UNIT Before cleaning disconnect the heating unit from the power supply The heating unit is supporting the control panel and therefore in order to take it out it is necessary to remove the panel itself pressing on the four rounded chrome fixing screw bolts see photo pg 15 The heating element can be cleaned washing it with a liquid sterilizing substance In this phase it is necessary to take extra special care in order to avoid that any liquids get into the control panel where all the electrical components are installed ATTENTION When it is necessary to take the control panel out of the base be careful because the heat ing element could be very hot
77. tors ref Baby Shuttle Normal Care Baby Shuttle Special Care Baby Shuttle Intensive Care Trade mark CGinevri Infant warmers Type ref A408 nWS09 IWBUS Trade mark Ginewvri Seres W509 PLUS Trade mark Ginevri Series Isola Neonatale Type ref ALHENA PLUS ELEVABILE PLUS FISSA ALHENA ELEVABILE ALHENA FISSA Trade mark Infant heating maltiress Type ref Acquatherm Trade mark Gine vri Oxygen analyzers Type ref LCD 1000 Trade mark Ginevri Oxygen tents Type ref Oxytent 1000 Oxytent 2000 Trade mark Ginevri Phototherapy lamps in neonatal hyperbilirubinemia Type ref IPR RPR RPS D GN Bilillght Trade mark Auxiliary infant warmers Type ref Hot Spot Trade mark Ginevri Air compressor for transport incubator Date 2004 04 21 Updated 2009 11 09 i lt r Sutra 2008 04 17 iM This is a translation of tha italian text which prevails in caso of doubts mer MO LEA ROSE ten Va Quran 41 ts 75571063 SSD rfi E wiwa mmi Bru Ungietro AU CDS sociae OO COO eure ISO Certificates UNI EN ISO 9001 Quality management system CSQ No Cert 9120 GIN1 IQnet No Cert IT 37100 UNI EN ISO 13485 Particular requirements for medical devices CSQ No Cert 9124 GIN2 0051 Ginevri s r l 8070bmd 01 03 2010 5 11 PolyTrend User manual white page
78. ulse Rate alarm can be set to up to256bpm The maximum possible setting level for the MIN Pulse Rate alarms s the level set for the MAX alarm The field below ON OFF indicates the activation or less of the a larms related to the pulse oxymeter From the Return field it is possible to go back to the main display screen ON the right the vital parameters and management of the incubator will always be shown and updated Positioning the sensor probe incorrectly lack of connection going over the limits set for and Pulse Rate will be signalled in the area reserved for Alarms with precise captions that indicate in unmis takable manner the alarm which has been activated that alarm is in any case also acoustic When the alarms are activated due to a disconnection or an incorrect positioning of the sensor probe no numerical values will be shown only dashes In the case of perfusion or too much light warnings will be shown on the SpO display screen Ginevri s r 8070bmd 01 03 2010 67 11 OGB PolyTrend User manual 7 3 HOT SPOT RADIANT HEATER 7533 optional The OGB PolyTrend can be equipped with the Hot Spot system optional It is a next application for supplementary warming of the little patient It is used in specially designed right angle of the incubator hood The Hot Spot 1 is a radiant infra red heat source controlled using the SKIN operating system of the incubator allowing for the maintenan
79. whatever corner of the world all that 15 needed 15 a FAX with a part number to obtain any spare part In fact by working with stamped mechanical components which guarantees the absolute re peatability for re making those components as well as the use of digital electronics allows for repairs to be done with the simple substitution of a board or a probe Polycarbonate is an unbreakable material which is resistant to high temperature over 150 C fire retardant and resistant to oils fats acids and normal disinfectants as well as other chemical agents The technology used in the construction of the OGB PolyTrend Incubators allows for complete dismantling by hand without need for tools of the entire machine within just a few minutes 14 8070bmd 01 03 2010 Ginevri s r l OGB PolyTrend User manual 11 In fact the use of one piece pressure injection polycarbonate for various components grants manoeuvrability of the individual unit pieces for perfect cleaning and sterilization in con junction with the absence of build up of dirt spore etc The two access doors open upwards in order to avoid cross infection These doors can also be open at the same time and the anchorage system allows the top of the hood to remain free The special pivot hinge 1s easily dismantled for complete sterilization and 1s silenced because of an in built silicon component Ginevri s r l 8070bmd 01 03 2010 15 11 OGB Poly

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