Dräger Babyleo TN500 Instructions For Use Manual Download

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Instructions for use

Babyleo TN500

WARNING

To properly use this medical device,
read and comply with these
instructions for use.

IncuWarmer
Software 1.0n

Summary of Contents for Babyleo TN500

Page 1: ...Instructions for use Babyleo TN500 WARNING To properly use this medical device read and comply with these instructions for use IncuWarmer Software 1 0n...

Page 2: ...2 Instructions for use Babyleo TN500 SW 1 0n This page has been left blank intentionally...

Page 3: ...rotection 15 2 12 Mechanical safety 15 2 13 Thermal radiation and fire prevention 18 2 14 Therapy and applications 19 2 15 Safety during cleaning and service 22 2 16 Safety instructions for accessorie...

Page 4: ...7 7 1 Alarm priorities and alarm signals 127 7 2 Suppressing and delaying the alarm signal 127 7 3 Dismissing the alarm message 130 7 4 Viewing the alarm history 130 8 Configuration 131 8 1 Entering p...

Page 5: ...ons 188 14 2 Operating data 188 14 3 Performance characteristics 189 14 4 Measured value display 190 14 5 Materials 192 14 6 Data exchange and interfaces 192 14 7 Device combinations 194 14 8 Connecti...

Page 6: ...screen texts 1 Numbers indicate the individual action steps of a sequence of actions The numbering restarts with 1 for each new sequence of actions 1 Numbers in parentheses refer to elements in illust...

Page 7: ...ussia Singapore USA Infinity EU USA China Brazil Australia India IncuWarmer EU Dr gerService Germany USA MEDIBUS X EU USA Oxycell EU USA KangarooMode EU USA ThermoMonitoring Germany France USA Tradema...

Page 8: ...TN500 provides controlled ambient conditions for premature babies and neonates The following parameters are regulated according to the intended use Temperature Humidity Oxygen option 2 3 Contraindicat...

Page 9: ...he skin temperature and adjusted accordingly or an alarm is triggered 2 6 Target groups 2 6 1 Definition of target groups The target groups may only carry out the following activities if they meet the...

Page 10: ...ruction 2 7 2 Precautionary statements Precautionary statements relate to action steps and warn of risks that may arise when executing the action steps Precautionary statements precede the action step...

Page 11: ...the symbols and product labels 2 8 3 Monitoring the patient s condition Monitoring of a patient s condition can range from direct observation to electronic monitoring by means of medical devices The...

Page 12: ...ctivated unintentionally 2 8 6 Modifications to the product Modifications to the product may lead to malfunctions which in turn may result in personal injury and property damage Do not modify this pro...

Page 13: ...SB port and service port that comply with the requirements set out in the standards and specifications listed in the technical data For further information see the following chapter Technical data pag...

Page 14: ...ich may lead to personal injury and property damage Do not use unauthorized oxygen cylinder valves Make sure that oxygen connectors and oxygen seals are kept free from oil and dust at all times Always...

Page 15: ...rations greater than 25 Vol combustible or explosive gas mixtures are likely to occur Do not operate the device in areas where combustible solvents or explosive anesthetic agents are used Do not use c...

Page 16: ...and between the hood frame and the front of the radiant warmer e g when opening and closing the hood 2 On the accessories of the side duct rails when closing the hood or lowering the hood arm 3 Betwee...

Page 17: ...tion engage all the locking brakes on the trolley and check that they are working properly 2 12 5 Falling objects Objects placed on the hood may fall off injuring the patient Remove all objects before...

Page 18: ...en the top edge of the radiant warmer and the ceiling Fig 2 Radiant warmer protective grid The radiant warmer may heat up objects in the beam path close to the radiant warmer to such an extent that to...

Page 19: ...s 2 14 1 Ambient conditions If the permissible ambient conditions are not complied with the values set for humidity and temperature in the patient compartment may not be achieved The patient may be pu...

Page 20: ...or as a clinical thermometer and do not use it to measure rectal temperature Use dry skin temperature sensors only Use covers recommended by Dr ger only e g ThermoPad sensor covers or similar covers w...

Page 21: ...ot use radio frequency surgical equipment endocardial catheters or defibrillators 2 14 7 Transdermal plasters If a plaster treated with an active agent transdermal plaster is applied to the patient s...

Page 22: ...ut the patient at risk due to irritation to the skin or mucous membranes Observe the instructions relating to disinfectants and cleaning agents Make sure that the device is adequately ventilated after...

Page 23: ...o condensate formation Follow the instructions for use of the humidifier in conjunction with the instructions for use of the breathing hose 2 16 3 Hoses and cables If the device or the trolley is move...

Page 24: ...earance and functions from the descriptions below For further information see the following chapter Range of functions page 41 3 1 1 Overview of operating modes The device can be operated as an incuba...

Page 25: ...lay unit Provides access to the user interface via touchscreen and rotary knob 4 Main column Houses the display unit and the alarm light Accessories such as arms etc can be mounted on the side duct ra...

Page 26: ...sh the device in a straight line Middle position green lock The castor can be moved in any direction Lower position red lock The castor is locked 10 Foot pedals Move the device up or down 11 Hand port...

Page 27: ...of the mattress tray on both sides 6 Warm air duct Directs warm air at the sides of the mattress tray into the patient compartment 7 X ray flap Provides access to the x ray tray on both sides with spa...

Page 28: ...e mattress tray 16 Mini walls Hold the mattress in place No Designation Description 27220 No Designation Description 1 Main switch Switches the device off completely 2 Serial port COM For connecting d...

Page 29: ...Standard rail Used for fixing accessories to the device e g Babylog VN500 bed coupling suction unit 9 Power cable connection Connects the device to the mains power sup ply 10 Oxygen connector option F...

Page 30: ...rature sensor connector yellow For connecting the skin temperature sensor for measuring the central skin temperature to the device 4 Peripheral skin tempera ture sensor connector white For connecting...

Page 31: ...ob Used for setting and confirming set values 4 Alarm suppression The Audio paused key suppresses the acoustic alarm signal for all active alarms for a certain period of time For further information s...

Page 32: ...pter Range of functions page 41 3 2 1 Main screen The main screen shows the most important warming therapy information Fig 10 Structure of the main screen 28500 No Designation Description 1 Header bar...

Page 33: ...alarm for a parameter the background of the corresponding parameter flashes No Designation Description 28477 No Designation Description 1 Alarms Opens the dialog window for setting the alarm limits an...

Page 34: ...roceed as follows a Touch the button next to the timer b Select Start Stop or Reset c To deactivate the timer touch the Timer button in the main menu bar d In the Timer dialog window touch the timer t...

Page 35: ...menu bar in the Alarms dialog window Via the Quick setup dialog window Fig 12 Quick setup dialog window for the air temperature example The quick setup dialog window for the alarm limits can be opened...

Page 36: ...ent in the patient compartment 3 Mattress option Shows the current mattress core temperature measurement 4 Oxygen option Shows the current oxygen concentration mea surement in the patient compartment...

Page 37: ...ed for setting the air temperature in the patient compartment No Designation Description 27253 No Designation Description 1 Skin temp Shows the current skin temperature measure ments 2 Radiant warmer...

Page 38: ...iews button is used to switch between the Main Thermomonitoring Developmental care and Family screen views Fig 15 Thermomonitoring screen view 27264 No Designation Description 1 Central Shows the cent...

Page 39: ...ht vary over a period of time This requires the Developmental Care package to be installed Fig 16 Developmental care screen view 27247 No Designation Description 1 Noise level Shows the measured noise...

Page 40: ...ed in this screen view The therapy values and settings cannot be changed in this screen view To change the screen view press the rotary knob Fig 17 Family screen view 27250 No Designation Description...

Page 41: ...ports side access panels and hood Color touch screen X ray tray Alarm management Light Working light Night light Moodlight Closed humidification system with automatic humidifier cleaning Data transfer...

Page 42: ...ents Kangaroo mode 3 3 1 3 Displays on the screen The device has the following display types Graphical trends Tabular trends Alarm history Logbook 3 3 1 4 Protocoling The device can save the following...

Page 43: ...equently used functions Operation Operating the hand ports and access panels Page 53 Opening and closing the hood Page 52 Adjusting the device height Page 48 Adjusting the mattress tray Page 49 Openin...

Page 44: ...e Babyleo TN500 SW 1 0n Product description Skin temperature Page 77 Radiant warmer power Page 91 Mattress core temperature Page 100 Humidity Page 94 Oxygen in the patient compartment Page 96 Monitori...

Page 45: ...o explains how the device supports the user in operating the device by means of visual and textual indicators color signals information texts alarm texts 4 1 1 Selecting a therapy mode 1 Touch the tab...

Page 46: ...parameter e g the skin temperature value The desired value is displayed in the therapy control 3 Press the rotary knob 3 to confirm The selected value is adopted The therapy control turns dark green...

Page 47: ...selection remains unconfirmed for more than 10 seconds the prompt flashes blue The backlighting of the rotary knob flashes yellow and an acoustic signal sounds If a selection remains unconfirmed for...

Page 48: ...collide with the gas cylinders Actuate height adjustment with caution and stop it promptly WARNING Risk to patient if hoses and cables are too short Hoses and cables may be subjected to tensile loadin...

Page 49: ...sting the mattress tray The height and tilt of the mattress tray can be adjusted by means of the buttons on the mattress tray control panel Prerequisites The device is in operation The bed tilt mechan...

Page 50: ...owest position is reached the LED in the button 2 goes out In radiant warmer operation Dr ger recommends setting the highest position for the mattress tray This position provides the most effective wa...

Page 51: ...ss tray 2 Cover the mattress with a sheet For further information see the following chapter Connecting the heated mattress page 101 4 4 Hood This chapter describes how to open and close the hood 4 4 1...

Page 52: ...take hold of the handle at the side of the hood and lift it forwards and up The hood moves up 2 To close the hood pull the handle at the side of the hood downwards The device closes the hood automati...

Page 53: ...ress tray is pulled out Procedure Operating the hand ports 1 To open the hand port push down the ridged part of the lock 1 with the hand or elbow The hand port opens 2 To close the hand port allow the...

Page 54: ...move the patient for kangarooing If the mattress tray is tilted or raised leave sufficient space above the patient Procedure 1 Lower the mattress tray and position it horizontally 2 Open one of the tw...

Page 55: ...ns can be locked Screen Device height adjustment Bed tilt mechanism Prerequisite The device is in operation Procedure 1 Touch the Lock button 1 in the main menu bar The Lock dialog window is displayed...

Page 56: ...length of 300 mm 11 81 in Syringe pumps monitors suction units examination lights trays 2 Duct rail on the side without the hood arm refer to additional infor mation 12 kg 26 5 lbs pivot arm and load...

Page 57: ...igh and medium priority alarms to a central hospital alarm system For further information see the following chapter Alarm Cause Remedy page 153 If the acoustic alarm signal of the device fails or the...

Page 58: ...t only high and medium priority alarms trigger the nurse call Bear in mind that using the nurse call does not absolutely guarantee that alarms will be transmitted Take note of alarms directly on the d...

Page 59: ...slot WARNING Risk to patient if unauthorized gases are used The use of compressed gases that are not approved for medical purposes may adversely affect the function of the device and put the patient...

Page 60: ...fting column to its lowest position Mount accessories with the lifting column in its lowest position Do not mount accessories too low down Procedure 1 Adjust the bottom of the gas cylinder holder 3 to...

Page 61: ...ylinder holder downwards and secure with the clamp 3 Fig 31 Connecting the oxygen cylinder 4 Note the contents of the product label on the oxygen connection Screw the compressed gas hose to the oxygen...

Page 62: ...ansfer between the device and an external medical or non medical device e g hemodynamic monitors data management systems or computers via a COM port Note the following software protocols before transm...

Page 63: ...st have been completed successfully Position the device so that the mains plug is readily accessible at all times The device can only be safely disconnected from the mains power supply by unplugging t...

Page 64: ...information see the following chapter Automatic selftest page 202 Procedure 1 Plug in the mains plug 2 Switch on the device at the main switch on the rear of the main column position I The start proce...

Page 65: ...in air temperature mode with the user specific settings Radiant warmer operation If the hood is open the device starts automatically in pre warm mode If the device was switched off for less than 2 ho...

Page 66: ...y be put at risk Ensure that the set therapy values are suitable for the new patient Make sure that the alarm system has not been rendered ineffective by setting the alarm limits to extreme values or...

Page 67: ...sfer height is reached when the red hatched label on the lifting column is completely covered 2 Switch off the device on the display unit using the Start standby key The Shut down dialog window is dis...

Page 68: ...Overview of incubator operation and radiant warmer operation 31326 QFXEDWRU RSHUDWLRQ 5DGLDQW ZDUPHU RSHUDWLRQ 0RGHV 6NLQ WHPSHUDWXUH PRGH DQJDURR PRGH DQJDURR PRGH LU WHPSHUDWXUH PRGH 0DQXDO PRGH 6N...

Page 69: ...ode activated 6 5 1 1 Condensation management High humidity settings may cause the inside of the hood to fog up To limit fogging the ClearView function can be activated If the ClearView on button is a...

Page 70: ...further information see the following chapter Skin temperature mode page 77 For further information see the following chapter Air temperature mode page 85 For further information see the following cha...

Page 71: ...ording to the ambient temperature The bars on the user interface show the maximum possible radiant warmer power in each situation If the mattress tray is tilted the radiant warmer power is adjusted to...

Page 72: ...e measured central skin temperature 6 6 3 Settings in radiant warmer operation The following settings can be made in radiant warmer operation Skin temperature skin temperature mode radiant warmer powe...

Page 73: ...00 power Within a period of 14 minutes and 30 seconds the power is gradually reduced In pre warm mode the therapy control displays either Pre or a value depending on the radiant warmer power Fig 37 Pr...

Page 74: ...r the transition To configure the transition select System setup Therapy Thermoregulation For further information see the following chapter Configuring the transition page 76 During the transition the...

Page 75: ...lso retained Example The hood is opened for a few minutes to check the position of the ventilation mask Mode Transition Temperature Air temperature mode The radiant warmer power corresponds to the air...

Page 76: ...transition adjust the temperature settings to the patient s needs Procedure 1 Touch the System setup button in the main menu bar 2 Touch the Therapy tab 3 Enter the password and confirm with OK 4 Sele...

Page 77: ...firm the extended range by pressing the rotary knob In incubator operation the air temperature in the device is regulated according to the set skin temperature In radiant warmer operation the radiant...

Page 78: ...screen in incubator operation 27245 No Designation Description 1 Skin mode Starts skin temperature mode 2 Skin temp Used for setting the skin temperature 3 Humidity Used for setting the humidity in t...

Page 79: ...ends that the central temperature and peripheral skin temperature are measured and monitored If 2 skin temperature sensors are used changes in skin temperature can be detected more quickly using the t...

Page 80: ...in the skin temperature sensor plugs Procedure 1 Push the yellow skin temperature sensor into the yellow socket 1 on the rear sensor wall The Skin mode tab in the therapy bar is available 2 Push the w...

Page 81: ...ome too hot or too cold Use dry skin temperature sensors only WARNING Risk to patient due to incorrect use of the skin temperature sensors If the rectal temperature is measured with the skin temperatu...

Page 82: ...4 Set the target skin temperature using the rotary knob 5 Press the rotary knob to confirm The therapy control turns dark green and displays the target value When the hood is closed the measured centr...

Page 83: ...thermomonitoring in a patient with cold stress the peripheral skin temperature 2 drops before the central skin temperature 1 and can be the first indication of cold stress Fig 42 Example of cold stre...

Page 84: ...u bar 2 Open the Alarms screen 3 Enter the password and confirm 4 Touch the Skin mode tab 5 Select Advanced skin temperature monitoring On and confirm The additional buttons for setting the skin tempe...

Page 85: ...user determines the appropriate temperature in the patient compartment The temperature is measured by a sensor in the patient compartment and compared with the set target value The air temperature can...

Page 86: ...de Selects air temperature mode 2 Air temp Used for setting the air temperature 3 Humidity Used for setting the humidity in the patient compartment 4 Oxygen option Used for setting the oxygen concentr...

Page 87: ...r radiation examination lights or phototherapy lights are active make sure that the temperature in the patient compartment remains non critical Check the patient s body core temperature at regular int...

Page 88: ...n in the main menu bar The Alarm limits dialog page is displayed 2 Set and confirm the upper alarm limit for the air temperature deviation 3 Set and confirm the lower alarm limit for the air temperatu...

Page 89: ...es The 2 skin temperature sensors are connected to the device and attached to the patient The Advanced skin temperature monitoring function is activated Procedure 1 Touch the Autoset all limits button...

Page 90: ...as a different mode is selected in the therapy bar air temperature mode is ended Procedure 1 In the therapy bar touch either the Skin mode tab or the Kangaroo mode tab The selected tab turns yellow 2...

Page 91: ...0 a timer starts and the following alarms are displayed after predefined time intervals After 14 minutes the Check patient s condition alarm is displayed After 15 minutes the radiant warmer is switche...

Page 92: ...egular intervals Only supply the patient with as much thermal radiation as is necessary Do not leave the patient unattended during radiant warmer operation WARNING Risk of fire underneath the radiant...

Page 93: ...herapy control turns dark green The radiant warmer power is set If the radiant warmer power is set above 30 a timer starts The device switches the radiant warmer off after 15 minutes 6 10 3 Setting th...

Page 94: ...ification system must be Aquadest distilled water An external water supply water bag or water bottle is connected to the device via a Luer Lock connector The water is evaporated in the humidification...

Page 95: ...in column The water bag or water bottle must be attached above the Luer Lock connector For further information see the following chapter Connectors on the rear sensor wall page 30 3 Close the clamp on...

Page 96: ...ess the rotary knob to confirm The therapy control turns dark green The value for the humidity is set 6 12 Oxygen option This chapter describes how to enrich the air in the patient compartment with ox...

Page 97: ...sure that the oxygen concentration in the patient compartment is always below 65 Always monitor the oxygen concentration in the patient s blood e g using blood gas analysis and a pulse oxymeter Always...

Page 98: ...equired oxygen concentration using the rotary knob 3 Press the rotary knob to confirm The therapy control turns dark green The oxygen concentration is set 6 12 3 Adjusting the oxygen alarm limits Prer...

Page 99: ...e has been operating for at least 30 minutes The Oxygen therapy control is at Off The external oxygen supply is turned off If oxygen has been used air the device thoroughly Open the hood and the side...

Page 100: ...nteed 6 13 Heated mattress option This chapter describes how to connect the heated mattress option to the device and how to set the mattress core temperature 6 13 1 Heated mattress overview The heated...

Page 101: ...the body core temperature of the patient with a thermometer WARNING Risk of patient injury due to damaged heated mattress If the cover of the heated mattress is damaged fluid may penetrate into the ma...

Page 102: ...facing the sensor wall 2 Pull the cable through the hose grommet in the center of the sensor wall and push it into the cable guide 3 Make sure that the cable runs downward between the bed support and...

Page 103: ...trol 1 in the therapy bar The therapy control turns yellow Fig 55 Therapy control for the heated mattress 2 Adjust the mattress core temperature manually using the rotary knob or 3 Turn the rotary kno...

Page 104: ...mode Air temperature Humidity Oxygen option Mattress core temperature option Radiant warmer operation Once kangaroo mode has been activated the device is operated in manual mode with 30 of the radian...

Page 105: ...evice The mother or father lies in a comfortable position on a couch next to the device or sits on a stool The last settings in incubator operation have been checked Air temperature Humidity Oxygen op...

Page 106: ...other s or the father s naked breast Also cover the patient with a blanket to prevent heat loss 5 If skin temperature sensors are used Check that the skin temperature sensors are correctly connected t...

Page 107: ...e Alarm limits dialog page is displayed for kangaroo mode Fig 58 Alarm limits for kangaroo mode 2 Set and confirm the lower alarm limit for the central skin temperature 3 Set and confirm the lower ala...

Page 108: ...mode has ended The device continues warming therapy with the settings that were active prior to kangaroo mode 3 Open the hood or side access panel and place the patient in the device 4 If skin temper...

Page 109: ...ce switches to manual mode with switched off radiant warmer Although all heat sources are switched off the skin temperature can still be monitored continuously Skin temperature sensors must be used fo...

Page 110: ...Connecting the skin temperature sensors page 79 Procedure 1 Touch the Alarms button 1 in the main menu bar The Alarm limits dialog page is displayed for Tolerate cooling The buttons for the alarm lim...

Page 111: ...ndow 3 Touch the Off button 4 Press the rotary knob to confirm Tolerate cooling has ended 6 16 Warm up option This chapter describes the warm up option 6 16 1 Overview of warm up During warm up the pa...

Page 112: ...nsors page 79 Procedure 1 Touch the Special procedures button 1 in the main menu bar The Special procedures dialog window is displayed Fig 62 Starting warm up 2 Open the Warm up 2 dialog page 3 Set an...

Page 113: ...m up has ended 6 16 3 2 Ending via the dialog window Procedure 1 Touch the Special procedures button in the main menu bar 2 Open the Warm up screen 3 Touch the Off button 4 Press the rotary knob to co...

Page 114: ...e device is in incubator operation At least the yellow skin temperature sensor for measuring the central skin temperature is connected For further information see the following chapter Connecting the...

Page 115: ...he air temperature is reached a message appears 6 17 3 Ending weaning Weaning can be ended at any time There are 2 ways of ending weaning On the main screen on the therapy bar In the Weaning dialog wi...

Page 116: ...y and the objects resting on it can be determined This weight is deducted from the measured weight when the patient is subsequently weighed so that only the patient s weight is displayed An acoustic s...

Page 117: ...e risk of an electric shock Do not touch the pins in the plug of the scale Procedure 1 Make sure that the scale cable faces the sensor wall 2 Place the bed support with the scale on the T bars from ab...

Page 118: ...s check it with a known weight value Double check therapeutic decisions that are based on the patient s weight by performing a reference measurement using an external scale WARNING Measuring error due...

Page 119: ...ay or falsifying the weight measurement 4 Touch the Weigh patient button 2 5 To tare the scale lift the patient up At least 200 g 0 44 lbs must be lifted off the mattress tray for the scale to be tare...

Page 120: ...he Scale dialog window remains open The mattress tray has not been adjusted or moved for 6 minutes WARNING Risk if taring is not performed When changes are made between measurements measuring errors m...

Page 121: ...ab 5 Touch the On button The weight can be adjusted manually in the Scale dialog window 6 Switch to the Scale dialog window and weigh the patient Observe the information in the following chapter Weigh...

Page 122: ...assette or x ray imaging plate are available The regulations for taking x rays in incubators are known The weight limit for the x ray cassette has been taken into account Bring the mattress tray into...

Page 123: ...with x ray tube assembly If the clearance above the device is too small the x ray tube assembly may hit the hood of the device Before aligning the x ray tube assembly make sure that there is enough ro...

Page 124: ...ices or music The sensors for measuring the noise level and the light level are located in the sensor wall of the device The currently measured value is displayed on the user interface The values can...

Page 125: ...cedure 1 Touch the Alarms button 1 in the main menu bar The Alarm limits dialog page is opened Fig 72 Monitoring limits for noise and light 2 Touch the Noise light tab 2 The buttons for the monitoring...

Page 126: ...ltaneously touch the audio port and the patient Procedure 1 Connect the audio cable to an MP3 player or a cellular phone 2 Insert the audio cable into the audio port on the rear of the sensor wall For...

Page 127: ...the urgency of the alarm If several alarms are displayed all alarms are suppressed by pressing the Audio paused key The duration of the suppression is based on the urgency The most urgent alarm determ...

Page 128: ...oo mode is started some alarms are delayed for 4 minutes as these alarms are to be expected when the device is opened For further information see the following chapter Setting skin temperature alarm l...

Page 129: ...in the header bar Peripheral skin temp sensor missing 5 Peripheral skin temperature high 15 Peripheral skin temperature low 15 4 Peripheral skin temperature too high 2 Skin temp sensor faulty heating...

Page 130: ...o the following alarms Procedure 1 Touch the Alarm reset button on the header bar on the main screen The alarm message has been dismissed and is no longer displayed Safety relevant alarms cannot be di...

Page 131: ...e device is in operation Procedure 1 Touch the System setup button 1 in the main menu bar The System setup dialog window and the Patient dialog page are displayed Fig 73 Input fields for patient data...

Page 132: ...Date of birth Gestational age wk d Birth weight g 5 Touch a button for the gender The gender is displayed in the header bar and in the Family screen view 6 Select a symbol for the patient in the list...

Page 133: ...m the picklist Example The current weight of the patient is 1057 g 2 33 lbs The range 1000 1100 g 2 2 2 43 lbs is selected from the pick list The recommended air temperature range 1 for the patient is...

Page 134: ...see the following chapter Starting air temperature mode page 87 8 2 Transferring data to another device This chapter describes how configuration data and patient data are transferred from one device t...

Page 135: ...e the new data record overwrites the existing data Check the configuration data and the current settings on the new device after the data import WARNING Risk of electric shock on USB port Connecting m...

Page 136: ...port The configuration data and the patient data can be transferred to another device 8 2 3 Importing data This chapter describes how to transfer the exported data to another device Prerequisites The...

Page 137: ...the USB mass storage device from the USB port The configuration data and the patient data have been transferred to the other device The configuration data can be transferred to another device 8 3 Dis...

Page 138: ...ed in the Thermoregulation tab A maximum of 2 overviews can be displayed at the same time The following combinations are possible Temperature and patient compartment Temperature and heating Patient co...

Page 139: ...atient weight is displayed in the Weight tab Only one measured value is saved per day For further information see the following chapter Weighing page 117 8 3 1 3 Vertical tab Noise light option The no...

Page 140: ...ends are displayed in tabular form in the Tabular trends tab The temporal resolution of the display can be set from 30 minutes to 24 hours Earlier time periods and other parameters can be displayed wi...

Page 141: ...w long the device and alarm system were shut down When the capacity of the logbook is reached the oldest entries are overwritten The following events and alarms are displayed All alarms their confirma...

Page 142: ...han 2 hours If the New patient button was activated when the device was switched on Patient specific settings The user can adjust the factory settings or the user specific settings to suit the current...

Page 143: ...Select the gender Select a symbol for the patient The symbol is also displayed in the Family screen view Vertical tab Heading or parame ter Description Factory setting General settings Color scheme S...

Page 144: ...In air temperature mode and manual mode the patient s skin temperature can be moni tored The skin temperature sensors must be connected to the device and attached to the patient Off If the Advanced s...

Page 145: ...he central and peripheral skin tem perature Off Kangaroo mode Skin temperature The skin temperature sensors must be connected to the device and attached to the patient Specify the following alarm limi...

Page 146: ...m light level 500 lux 46 fc Threshold for high exposure Threshold for high light level 800 lux 74 fc Vertical tab Heading or parame ter Description Factory setting Thermoregulation Enter and confirm t...

Page 147: ...onfirm the configuration password If a specific device configuration is available this is shown here USB mass storage device If a USB mass storage device is connected and a specific device configurati...

Page 148: ...its Enter and confirm the configu ration password Temperature Specify the unit C or F C Weight option Specify the unit g or lbs oz g Light option Specify the unit lux or fc lux Alarm volume Enter and...

Page 149: ...vice personnel Enter and confirm the configu ration password for the follow ing functions Activating applications Adjusting the Oxycell O2 sensors Remote Service Help Ticket Device Check Service menu...

Page 150: ...the lifting column is no longer visible At this height the device can be moved without the radiant warmer hitting a door frame for example Fig 79 Label on the lifting column 9 1 2 Transferring the pat...

Page 151: ...hocks and vibrations as much as possible e g when crossing door thresholds and passing through door frames Check the functional integrity of the accessories during and after the intrahospital transpor...

Page 152: ...t standby key The Shut down dialog window is displayed 10 Touch the Shut down button and confirm The device functions are shut down 11 Switch off the device using the main switch on the rear of the ma...

Page 153: ...larms appear in this table several times with different priorities because their priority may change under certain conditions Alarm priority Exclamation marks Color High Red Medium Yellow Low Cyan Ala...

Page 154: ...central skin temperature sensor yellow is faulty Replace the sensor 50 Central skin temp sensor missing The central skin temperature sensor yellow is not con nected Make sure that the sensor is corre...

Page 155: ...djust them if applicable 52 Check settings Settings were imported from a USB mass storage device Check the settings and adjust them if applicable 51 Check settings An internal fault occurred Check the...

Page 156: ...m is low Make sure that the water supply is correctly con nected Refill the water supply The humidity sensor is faulty Contact specialized service personnel 58 Humidity not confirmed The setting was c...

Page 157: ...l panel Contact specialized service personnel 103 MEDIBUS X communica tion error A MEDIBUS X communica tion error occurred Switch off the MEDIBUS X protocol Contact specialized service personnel The M...

Page 158: ...sor faulty The peripheral skin tempera ture sensor white is faulty Replace the sensor 118 Peripheral skin temp sen sor missing The peripheral skin tempera ture sensor white is not connected Make sure...

Page 159: ...ice personnel 100 Skin mode not confirmed The mode was selected but it was not confirmed Select skin mode and press the rotary knob to confirm 117 Skin temp sensor faulty heating off At least one of t...

Page 160: ...Switch off the device and let it cool down Contact specialized service personnel 164 Temperature high in warm air duct The warm air duct is cov ered Make sure that the warm air duct is not covered An...

Page 161: ...hem if applicable Check the patient s condition Alarm pri ority Alarm Cause Remedy Condition Cause Remedy A loud acoustic signal sounds The failure is also signaled on the display by a red indicator l...

Page 162: ...just ment or bed tilt mecha nism Restart the device Do not actuate the bed tilt mecha nism Set the device to transfer height Contact specialized service per sonnel Condition Cause Remedy The mattress...

Page 163: ...tared Taring load is too high The maximum permissi ble tare weight has been exceeded Tare the scale again and only lift the patient Weighing canceled The weight of the patient could not be determined...

Page 164: ...of the fan impeller receptacle stop using the device and contact the specialized service personnel Procedure 1 Switch off the device on the display unit using the Start standby key 2 Switch off the de...

Page 165: ...Instructions for use Babyleo TN500 SW 1 0n 165 Troubleshooting Fig 82 Fan impeller receptacle 13 All liquid must be removed from the heating plate before the device is moved 30275 1...

Page 166: ...cleaning can be performed with the hood open or closed Dr ger recommends opening the hood An open hood allows humidity to escape and prevents possible condensate formation Prerequisites There is no p...

Page 167: ...e the automatic humidifier cleaning has been canceled repeat the function as soon as possible Procedure 1 To cancel the humidifier cleaning touch the Cancel button The humidifier cleaning is canceled...

Page 168: ...ignation 1 Heated mattress option or SoftBed mattress 2 Mini walls 3 Hood sealings 4 Side access panels and front access panel 5 Drawer insert option 6 Hose grommets 7 Fan impeller 8 Small and large w...

Page 169: ...cleaning hot surfaces may cause injuries Before dismantling make sure that the device has cooled down Do not touch the hot surfaces near to the radiant warmer the convection heater and the humidifier...

Page 170: ...ll is free at the center tilt it inwards with a rotational movement 2 towards the mattress tray Remove the mini wall 5 If the heated mattress and the scale are available remove both cables on the rear...

Page 171: ...e performed by reprocessing personnel or by persons who are responsible for the reprocessing 11 3 1 Information on disinfectants Use disinfectants that are nationally approved and are suitable for the...

Page 172: ...material compatibility and effectiveness Surface disinfection Surface disinfection using the following surface disinfectant is suitable for the device and all components non critical and semi critica...

Page 173: ...mal At least 5 minutes 90 C 194 F Class of active ingredi ent Surface disinfectant Manufacturer Oxygen releasing agents Descogen Liquid Antiseptica Descogen Liquid r f u Dismozon plus BODE Chemie Dism...

Page 174: ...shock when switching on the device Device malfunctions Make sure that no liquid penetrates into the device WARNING Risk of O2 sensor malfunction Disinfectants or cleaning agents which contain formalde...

Page 175: ...f the hand ports 4 Carefully wipe the grip on the X ray flap 5 To clean the air ducts of the X ray flap 1 pull a piece of cloth soaked in disinfectant through each duct Fig 86 Air ducts of the X ray f...

Page 176: ...t a suitable cycle 4 Use demineralized water for the final rinsing 5 After the cycle has ended check the product for visible soiling If required repeat the cycle or carry out a surface disinfection wi...

Page 177: ...nsert the fan impeller and press it down until it engages 2 Insert the large cover for the warm air duct 3 Insert the small cover for the warm air duct 4 Attach the T bars 5 Place the bed support on t...

Page 178: ...ble guides and plug in the plug on the rear of the sensor wall 9 Insert the 2 mini walls at both ends of the mattress tray 10 Insert the hose grommets in the following positions Sensor wall 3 pieces o...

Page 179: ...further information see the following chapter Assembly and preparation page 56 2 Check for operational readiness For further information see the following chapter Checking for operational readiness pa...

Page 180: ...state of a product Maintenance Regular specified measures intended to maintain the functional integrity of a product Repair Measures intended to restore the functional integrity of a prod uct after a...

Page 181: ...evant verification authority To check that the scale is accurate and is working correctly specialized service personnel can carry out an appropriate examination of the scale For more information conta...

Page 182: ...arm The hood arm functions safely The following components do not exhibit any visible damage Trolley and housing parts Display unit Sensor unit Gas inlets Heated mattress option or SoftBed mattress an...

Page 183: ...e 12 2 4 Metrological checks If required by applicable regulations the following measurement functions must be checked in the specified intervals 12 2 4 1 Skin temperature measurement Prerequisites Th...

Page 184: ...rval Measure Target group Skin temperature sen sors Weekly at the lat est when the patient changes Replace Users Sensor covers Weekly at the lat est when the patient changes Replace Users Hose grommet...

Page 185: ...e filter cloth 3 Insert a new filter cloth 4 Close the flap and check that it is securely locked 12 5 Repair Dr ger recommends that all repairs are performed by Dr gerService and that only authentic D...

Page 186: ...om USB button The activation codes found on the storage medium are uploaded and displayed in the list 12 6 2 Manual entry of the activation code 1 Touch the Enter code Enter code button 2 Use the keyb...

Page 187: ...isposal of electrical and electronic devices is subject to special guidelines This device must be disposed of in accordance with national regulations In countries of the European Union Dr ger will org...

Page 188: ...onsumption power consumption 10 A 1000 W Gas supply option O2 operating pressure 2 7 to 6 0 bar or 270 to 600 kPa or 39 to 87 psi O2 peak input flow 45 L min at ambient pressure O2 connector Depending...

Page 189: ...ed mattress option Type BF Classification in compliance with Directive 93 42 EEC Annex IX Class IIb UMDNS code Universal Medical Device Nomenclature System nomenclature for medical devices 15 610 Elec...

Page 190: ...8 F Maximum CO2 concentration in the incubator measured in accordance with IEC 60601 2 19 0 5 Vol Fresh air filter The fresh air filter is located in the rear of the sensor wall 14 4 Measured value d...

Page 191: ...urement range Normal range 30 to 99 R H Extended range 10 to 29 R H Measurement uncertainty in normal range 10 Setting range Off 30 to 99 r H in steps of 1 AUTO Noise measurement in patient compartmen...

Page 192: ...ts of the standard IEC 60601 1 on accessible sec ondary circuits with max 60 V DC nominal volt age Type ODU MEDI SNAP 3 pole with 205 coding J Operating voltage 30 V max Current 250 mA max Power 7 5 W...

Page 193: ...with FAT16 or FAT32 Service port Only for Dr gerService Only connect devices that fulfill the require ments of the standard IEC 60950 1 on unearthed SELV circuits or the requirements of the standard I...

Page 194: ...data can be exchanged by means of wired or wireless technologies An IT network can be any data interface e g RS232 LAN USB printer interface that is described in standards and conventions During oper...

Page 195: ...in the following standards Wired networks IEEE 802 3 Wireless networks IEEE 802 11 b g n If the device is used with a layer 2 switch or a layer 3 switch the port settings must be configured on the ne...

Page 196: ...accessories Other accessories which do not affect EMC compliance may be used if no other reasons forbid their use see other sections of the instructions for use The use of noncompliant accessories can...

Page 197: ...gnetic environment as specified below The user must make sure that the medical device is used in such an environment 14 9 4 Electromagnetic immunity The medical device is intended for use in an electr...

Page 198: ...ice requires continued operation during mains power supply interruptions it is recommended that the medical device is powered from an unin terruptible power supply or a bat tery Dip 60 5 periods 60 5...

Page 199: ...rms of license Additional information regarding the open source software used in this device is available at the following web page www draeger com opensource Max PEIRP W 150 kHz to 2 5 GHz All other...

Page 200: ...2 and 100 4 F The difference between the defined set value and the measured actual value for the skin temperature regulates the air temperature in the device If the defined set value is greater than...

Page 201: ...n the displayed mattress core temperature may be higher than the temperature in the patient compartment Radiant warmer operation In radiant warmer operation the surface temperature of the mattress tra...

Page 202: ...fier heater X X Safety shut down X Every 24 hours Electronic components in areas flushed with oxygen Safety shut down X Safety test X Alarm loudspeaker Acoustic and optical tests by the user X 2 acou...

Page 203: ...priorities at the same tone frequency and volume level Alarm Duration of alarm delay Audio paused key faulty 10 s Centr sensor missing heating off 8 s Central skin temp sensor missing 8 s Fan motor f...

Page 204: ...tware protocol E g monitors data man agement systems Nurse call port Connects the device to the central hospital alarm sys tem Central hospital alarm sys tem USB port For connecting a USB mass storage...

Page 205: ...SD Electrostatic Discharge electrostatic discharge fc Foot candle HF High frequency hPa Hectopascal ID Identification kg Kilogram L Liter LAN Local network lbs Pound unit of mass LED Light emitting di...

Page 206: ...se Caution Follow the accompanying documentation Symbol Main switch Off On Start standby Audio paused Mains voltage Oxygen cylinders on this side of the device only No oxygen cylinders on this side of...

Page 207: ...mains voltage Applied part of type BF body floating High density polyethylene class 2 PVC free polyvinyl chloride DEHP free Not made with natural rubber latex Lay the patient on this side of the heat...

Page 208: ...208 Instructions for use Babyleo TN500 SW 1 0n Annex Night light Move the device downwards Move the device upwards Symbol Explanation...

Page 209: ...skin temperature Air temperature Radiant warmer Convection heater Mattress core temperature Humidity Acoustic alarm signal temporarily suppressed Alarm inactive Upper alarm limit Lower alarm limit Loc...

Page 210: ...entral skin temperature yellow peripheral skin temperature white Scale Explanation Socket for the scale Seal for the scale Audio port Explanation Socket for the audio port Oxygen connector Explanation...

Page 211: ...ice to either side of the main column Weight of device and maximum total weight of the device Heated mattress Explanation Socket for the heated mattress Humidification system Explanation Socket for th...

Page 212: ...212 Instructions for use Babyleo TN500 SW 1 0n This page has been left blank intentionally...

Page 213: ...1 1 Information for the configuration password To prevent unauthorized alteration the device settings for Babyleo TN500 are protected by a password with 0 to 8 digits For further information see the f...

Page 214: ...214 Instructions for use Babyleo TN500 SW 1 0n This page has been left blank intentionally...

Page 215: ...89 110 Kangaroo mode 107 Oxygen 98 Skin temperature 83 110 Tolerate cooling 110 Alarm message 153 Dismissing 130 Alarm priorities 127 127 153 Alarm signal 127 Delaying 127 Suppressing 127 130 Alarm to...

Page 216: ...142 Screen layout 143 Specifying 142 System 147 Therapy 146 User specific 142 Dialog window Quick setup 35 Disassembling Components 169 Device 167 Disinfectant Surface disinfection 173 Disinfectants...

Page 217: ...fer 150 IT networks 194 K Kangaroo mode 104 Alarm limit 107 Duration 104 Ending 108 Main screen 104 Starting 105 L Licensed application Activating 186 Lifting column Safety check 181 Liquid on heating...

Page 218: ...djusting 121 Performance characteristics 9 Power failure alarm 161 Precautionary statements 10 Pre warm mode 72 Product description 24 Product labels Safety instruction 11 R Radiant warmer operation 7...

Page 219: ...temperature mode 77 Ending 85 Extended temperature range 77 Safety mode 201 Setting advanced alarm limits 84 Setting alarm limits 83 Starting 82 Temperature range 77 Skin temperature regulation Descr...

Page 220: ...the height of the device 162 Adjusting the mattress tray 162 Fault with the oxygen supply 163 Liquid on heating plate 164 Power failure alarm 161 Weighing 162 U Unlock 55 Bed tilt mechanism 55 Device...

Page 221: ...Instructions for use Babyleo TN500 SW 1 0n 221 This page has been left blank intentionally...

Page 222: ...ive 93 42 EEC concerning medical devices Manufacturer Dr gerwerk AG Co KGaA Moislinger Allee 53 55 D 23542 L beck Germany 49 451 8 82 0 FAX 49 451 8 82 2080 http www draeger com 9054863 GA 6016 170 en...

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Dräger Babyleo TN500, Instructions For Use Manual

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