Page 1 Instructions for use Babyleo TN500 IncuWarmer WARNING Software 1.0n To properly use this medical device, read and comply with these instructions for use.
Page 2 This page has been left blank intentionally. Instructions for use Babyleo TN500 SW 1.0n...
Page 3: Table Of Contents
Hand ports and access panels ............Locking and unlocking functions............. Assembly and preparation ..............Maximum load ................Nurse call..................Adjusting the gas cylinder holder and connecting the oxygen cylinder Establishing potential equalization..........MEDIBUS connection for data transfer........... Instructions for use Babyleo TN500 SW 1.0n...
Page 4 Fault during weighing..............10.6 Fault with the oxygen supply ............10.7 Removing liquid from the heating plate .......... 11 Reprocessing ................... 11.1 Automatic humidifier cleaning............11.2 Dismantling ..................11.3 Information on reprocessing ............Instructions for use Babyleo TN500 SW 1.0n...
Page 5 Schematic representation of alarm and information tones ..... 15.6 Interfaces ..................15.7 Abbreviations .................. 15.8 Symbols ..................15.9 Symbol in the software ..............15.10 Product labels ................. 16 Password ....................16.1 Configuration password for Babyleo TN500 Software 1.0n.... Index......................Instructions for use Babyleo TN500 SW 1.0n...
Page 6: Information About This Document
IEC 60601-1, but also for consumable parts, removable parts and attached parts. Illustrations Depending on the configuration, the products and screen content shown in this document may differ from the actual on-site products. Instructions for use Babyleo TN500 SW 1.0n...
Page 7: Trademarks
Schülke & Mayr acryl-des ® Antiseptica Descogen ® BODE Chemie Dismozon ® Clorox Dispatch ® Medentech Klorsept ® Ecolab USA Oxycide ® DuPont Virkon ® Chemische Fabrik Dr. Weigert Neodisher ® ODU MEDI-SNAP Instructions for use Babyleo TN500 SW 1.0n...
Page 8: Safety-Related Information
55 cm (22 in). The device can be operated as either a closed care unit or an open care unit. As a closed care unit, Babyleo TN500 is an incubator. Neonates are kept warm in the patient compartment with humidifiable air, which can be enriched with oxygen (option).
Page 9: Essential Performance Characteristics
Service personnel are, e.g., hospital technicians trained in servicing the device. Activity Requirement Installation Specialist knowledge in electrical engineer- ing and mechanics Basic service work (inspection, main- Experience in the servicing of medical tenance according to the "Mainte- devices nance" chapter) Instructions for use Babyleo TN500 SW 1.0n...
Page 10: Information On Safety Instructions And Precautionary Statements
Warning sign Signal word Consequences of non-compliance WARNING May result in death or serious injury. CAUTION May result in moderate or minor injury. NOTICE May result in property damage. Instructions for use Babyleo TN500 SW 1.0n...
Page 11: Basic Safety Instructions
► The target group has been trained to perform the task. ► The target group has read the sections of these instructions for use relating to the activity concerned and noted the safety instructions and precautionary statements they contain. Instructions for use Babyleo TN500 SW 1.0n...
Page 12 Only use the service port on the device for servicing purposes. Any other use may lead to malfunctions, which in turn may result in personal injury. ► Do not use the service port (RJ45) to connect the device to the IT network. Instructions for use Babyleo TN500 SW 1.0n...
Page 13: Electrical Safety
► Comply with the requirements for an electromagnetic environment. For further information, see the following chapter: ''Electromagnetic environment'' (page 197). Instructions for use Babyleo TN500 SW 1.0n...
Page 14: Use Of Oxygen
O hood. ► Be aware that Babyleo TN500 displays no alarms in the case of an external oxygen supply, e.g., via an O hood. ► In the patient compartment use only electrical devices that are approved for use in an oxygen-enriched atmosphere.
Page 15: Explosion Protection
► Do not exceed the maximum load of the x-ray tray. ► During transfer make sure that the device does not tip over due to incorrect alignment of accessories on the duct rail. Instructions for use Babyleo TN500 SW 1.0n...
Page 16 Between the compressed gas cylinder and accessories fixed to the duct rail (e.g., when lowering the device) Between the trolley and the power cable connection (e.g., when lowering the device) Between the trolley and the drawer (e.g., when lowering the device) Instructions for use Babyleo TN500 SW 1.0n...
Page 17 ► Perform service measures at the specified intervals. ► Replace the fan impeller when damaged. ► Check that the side access panels, the front access panel, and the hand ports lock securely, and repair if necessary. Instructions for use Babyleo TN500 SW 1.0n...
Page 18: Thermal Radiation And Fire Prevention
► When additional heat sources (e.g., solar 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 intervals. Instructions for use Babyleo TN500 SW 1.0n...
Page 19: Therapy And Applications
USB port, after changing the operating mode, when using the default settings. ► Measure the body core temperature at regular intervals using a separate thermometer. Instructions for use Babyleo TN500 SW 1.0n...
Page 20 ► Only open the hand ports or access panels temporarily and only for as long as is necessary. ► Only pull out the mattress tray or x-ray tray temporarily and only for as long as is necessary. Instructions for use Babyleo TN500 SW 1.0n...
Page 21 2.14.8 Sensor unit If the slots on the sensor unit become blocked, malfunction may be caused. ► Make sure that the slots on the sensor unit are kept clear at all times. Instructions for use Babyleo TN500 SW 1.0n...
Page 22: Safety During Cleaning And Service
► Comply with the ambient conditions for operation and storage of the device. ► If a device is behaving suspiciously or is clearly malfunctioning, replace it with a device in proper working order. Instructions for use Babyleo TN500 SW 1.0n...
Page 23: Safety Instructions For Accessories
► Do not use the working light on the device when examining the patient. ► Always use an examination light in accordance with the standard IEC 60601-2- 41 when examining the patient. Instructions for use Babyleo TN500 SW 1.0n...
Page 24: Product Description
Fig. 4 Incubator operation (hood closed) and radiant warmer operation (hood open) The user's operating location can be on the right side, on the left side, or at the front of the device. Instructions for use Babyleo TN500 SW 1.0n...
Page 25 Located at the 4 corners, for routing cables and hoses into the patient compartment. Gas cylinder holder (option) For securing oxygen cylinders or compressed air cylinders. Lifting column For adjusting the height of the device. Instructions for use Babyleo TN500 SW 1.0n...
Page 26 Hood Closes the patient compartment. Can be man- ually opened or closed. Hood arm Attaches the hood to the main column. Con- tains the mechanism for opening and closing the hood. Instructions for use Babyleo TN500 SW 1.0n...
Page 27 Used for fixing accessories to the device, e.g., Babylog VN500 bed coupling, suction unit. Bed support Holds the x-ray tray and the scale (option). Front access panel Provides access to the patient. Can be hinged down. Instructions for use Babyleo TN500 SW 1.0n...
Page 28 USB port For connecting a USB mass storage device for the import and export of configuration data and patient data. Service port (RJ45) Connects the device to the service PC for ser- vicing purposes. Instructions for use Babyleo TN500 SW 1.0n...
Page 29 Oxygen connector (option) For connecting the device to an oxygen cylin- der or to a wall terminal unit for the supply of oxygen from the central gas supply system. Rating plate Shows device-specific information. Instructions for use Babyleo TN500 SW 1.0n...
Page 30 Luer Lock connector Connects the water bag hose to the humidifi- cation system of the device. Audio connector (option) For connecting an audio cable from an exter- nal playback device. Instructions for use Babyleo TN500 SW 1.0n...
Page 31 Power supply indicator Indicates the mains power supply status. Mains power supply present: LED lights green. Start/standby key key switches the device on or off. Instructions for use Babyleo TN500 SW 1.0n...
Page 32: Screen Views
Alarm priority is indicated by different back- ground colors. All alarms Shows that there are more than 3 active alarms. Touch the button to display all current alarms. Alarm reset Indicates that the current alarms can be reset. Instructions for use Babyleo TN500 SW 1.0n...
Page 33 Activates the locking and unlocking of the height adjustment, the bed-tilt mechanism, and the touchscreen. Trends/data... Opens the dialog window to display graphical and tabular trends, measured values and set- tings, and the logbook. Instructions for use Babyleo TN500 SW 1.0n...
Page 34 To deactivate the timer, touch the Timer... button in the main menu bar. d In the Timer dialog window, touch the timer that should be deactivated. ✓ The button turns light green. The timer disappears from the header bar. Instructions for use Babyleo TN500 SW 1.0n...
Page 35 The quick setup dialog window for the alarm limits can be opened by touching the following parameter fields in the monitoring area: – Skin temperature – Air temperature – Oxygen (option) – Noise level (option) – Light level (option) Instructions for use Babyleo TN500 SW 1.0n...
Page 36 Selects kangaroo mode. ClearView on Reduces condensation on the inside of the hood. Mattress (option) Used for setting the mattress core tempera- ture. Oxygen (option) Used for setting the oxygen concentration in the patient compartment. Instructions for use Babyleo TN500 SW 1.0n...
Page 37 Skin mode Selects skin temperature mode. Manual mode Selects manual mode. Kangaroo mode Selects kangaroo mode. Mattress (option) Used for setting the mattress core tempera- ture. Warmer Used for setting the radiant warmer power. Instructions for use Babyleo TN500 SW 1.0n...
Page 38 Shows the central skin temperature. Peripheral Shows the peripheral skin temperature. Difference Shows the difference between the central and the peripheral skin temperature. Skin temp. Shows the patient's skin temperature values as a graphical trend. Instructions for use Babyleo TN500 SW 1.0n...
Page 39 Shows the measured light level in lux or fc as a graphical trend. Light level Shows the current light level measurement in lux or fc. Noise level Shows the current noise level measurement in dB(A). Instructions for use Babyleo TN500 SW 1.0n...
Page 40 Designation Description Therapy settings Show the current therapy settings (green background). Therapy values Show the current therapy value measurements in the patient compartment. Patient data Show, e.g., the patient's name, age, and weight. Instructions for use Babyleo TN500 SW 1.0n...
Page 41: Range Of Functions
– Developmental care package – Audio stimulation – Measurement of light level and noise level in the patient compartment The device is intended for use with the accessories indicated in the list of accessories. Instructions for use Babyleo TN500 SW 1.0n...
Page 42 (using country-specific NIST gas cylinder connection or DISS connection) A compressed gas cylinder Dräger pressure reducer or is connected to an external third-party pressure reducer ventilation unit Instructions for use Babyleo TN500 SW 1.0n...
Page 43 Page 87 Skin temperature Page 82 Radiant warmer power Page 92 Mattress core temperature Page 103 Humidity Page 95 Oxygen in the patient compartment Page 97 Monitoring therapy parameters Air temperature Page 85 Instructions for use Babyleo TN500 SW 1.0n...
Page 44 Product description Monitoring therapy parameters Skin temperature Page 77 Radiant warmer power Page 91 Mattress core temperature Page 100 Humidity Page 94 Oxygen in the patient compartment Page 96 Instructions for use Babyleo TN500 SW 1.0n...
Page 45: Operating Concept
1 Touch the tab (1) on the user interface (e.g., the Skin mode tab).  The tab turns yellow. Fig. 18 Selecting a therapy mode 2 Press the rotary knob (2) to confirm.  The selection is adopted. ✓ The tab turns dark green. Instructions for use Babyleo TN500 SW 1.0n...
Page 46 Colors indicate the availability of functions and settings, e.g., for the following control elements: – Therapy controls and buttons – Rotary knob – Therapy bar – Dialog windows The following illustration shows the color scheme for the tabs: Instructions for use Babyleo TN500 SW 1.0n...
Page 47 – If a selection remains unconfirmed for more than 15 seconds, the rotary knob and prompt stop flashing. The device resets the selection. An alarm text warns the user that the function or setting has not been adopted. Instructions for use Babyleo TN500 SW 1.0n...
Page 48: Adjusting The Device Height
► When using the height adjustment mechanism and the trolley, always ensure that no hoses and cables become disconnected. ► Lock the double castors on the trolley with the locking brakes. Instructions for use Babyleo TN500 SW 1.0n...
Page 49: Adjusting The Mattress Tray
► If the mattress tray is pulled out, operate the device height adjustment with caution and stop it promptly ahead of an obstacle. ► Ensure that hoses of a sufficient length are used when using an external ventilator. Instructions for use Babyleo TN500 SW 1.0n...
Page 50  When the maximum mattress tray tilt is reached, the LED in the button (3 or 4) goes out. ✓ The height and tilt angle of the mattress tray are set. Instructions for use Babyleo TN500 SW 1.0n...
Page 51: Hood
Overview of the direction of movement The hood is attached to the hood arm. The illustration below shows the direction of movement when the hood is opened. Fig. 24 Direction of movement of the hood Instructions for use Babyleo TN500 SW 1.0n...
Page 52: Hand Ports And Access Panels
– On the front of the device there is the front access panel (2) with one hand port (3). Fig. 25 Access panels and hand ports When the hand ports or access panels are open, a warm air curtain remains in place, preventing the patient compartment from cooling down. Instructions for use Babyleo TN500 SW 1.0n...
Page 53 Raise the front access panel and fold it down.  The access panel hangs vertically down towards the floor. 3 To close an access panel, fold it up and lower it slightly.  The access panel is closed. Instructions for use Babyleo TN500 SW 1.0n...
Page 54 2 Open one of the two side access panels. 3 Open the X-ray flap. 4 Pull out the bed support on one side of the device using the recessed grips (1). Fig. 27 Bed support with recessed grips Instructions for use Babyleo TN500 SW 1.0n...
Page 55: Locking And Unlocking Functions
2 Use the following buttons to lock or unlock a function: – The right-hand button (2) locks the function. – The left-hand button (3) unlocks the function. 3 Confirm the selection using the rotary knob. ✓ The function is locked or unlocked. Instructions for use Babyleo TN500 SW 1.0n...
Page 56: Assembly And Preparation
Water bag or water sack Standard rail, rear 2.5 kg (5.5 lbs) Baskets, Babylog VN500 bed coupling, suction unit Gas cylinder holder 10 kg (22 lbs) Oxygen cylinders or com- (option) pressed air cylinders Instructions for use Babyleo TN500 SW 1.0n...
Page 57: Nurse Call
If the "Audio paused" key is pressed during an alarm, the acoustic alarm signal on the device and the nurse call are suppressed.During this time, any new alarms that occur do not trigger a nurse call. Instructions for use Babyleo TN500 SW 1.0n...
Page 58: Adjusting The Gas Cylinder Holder And Connecting The Oxygen
– A pressure reducer has been screwed onto the oxygen cylinder valve. – The following parts are available: – Compressed gas hose – 2 guard plates for the duct rails – 3 mm hex key Instructions for use Babyleo TN500 SW 1.0n...
Page 59 ► 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 open oxygen cylinder valves slowly. Instructions for use Babyleo TN500 SW 1.0n...
Page 60 Adjusting the height of the gas cylinder holder 4 Fit the spacers to the duct rails (1) to prevent the accessories colliding with the oxygen cylinder when the device is lowered. ✓ The gas cylinder holder has been adjusted. Instructions for use Babyleo TN500 SW 1.0n...
Page 61 The gas cylinder holder can also be used for compressed air cylinders. Compressed air cylinders can be attached to both sides of the device. Further information about gas cylinders can be found in the technical data. Instructions for use Babyleo TN500 SW 1.0n...
Page 62: Establishing Potential Equalization
This may put the patient at risk. ► Do not use data transferred via the COM port as the sole source of information. Procedure: 1 Connect an external device to the COM port. 2 Configure the COM port. Instructions for use Babyleo TN500 SW 1.0n...
Page 63: Operation
For further information, see the following chapter: ''Adjusting the O sensors'' (page 99) ✓ Only operate the device when all test steps and the automatic selftest have been completed successfully. Instructions for use Babyleo TN500 SW 1.0n...
Page 64: Switching On The Device
Fig. 32 Start/standby key on the display unit 5 Check that the touch screen and rotary knob are working correctly. ✓ Once the automatic selftest has been completed, the main screen is displayed. Instructions for use Babyleo TN500 SW 1.0n...
Page 65 – By touching the Current patient button, the device continues operation with all existing patient data and the most recent settings. Skin temperature mode is not suitable for warming up the device during incubator and radiant warmer operation. Instructions for use Babyleo TN500 SW 1.0n...
Page 66 ► In incubator operation, wait for a warm-up time of 30 minutes. Procedure: 1 Select the desired mode in the therapy bar. 2 Set the desired temperature with the therapy control. 3 Set additional parameters (e.g., humidity). ✓ The therapy settings have been adjusted. Instructions for use Babyleo TN500 SW 1.0n...
Page 67: Switching Off The Device
5 Disconnect the mains plug. 6 Fasten the power cable to the device, e.g., by wrapping it around the standard rail. Instructions for use Babyleo TN500 SW 1.0n...
Page 68: Operating Modes
The device can be operated as an incubator and as a radiant warmer. The diagram shows the two operating modes with the corresponding settings and applications. Fig. 34 Overview of incubator operation and radiant warmer operation Instructions for use Babyleo TN500 SW 1.0n...
Page 69: Incubator Operation
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 activated in the therapy bar, the radiant warmer operates at low power. This warms the hood, reducing fogging. Instructions for use Babyleo TN500 SW 1.0n...
Page 70 For further information, see the following chapter: ''Kangaroo mode'' (page 104) In incubator operation set the lowest position for the mattress tray so that there is as much space as possible for the patient. This position also offers good access to the patient. Instructions for use Babyleo TN500 SW 1.0n...
Page 71: Radiant Warmer Operation
Standard view in radiant warmer operation with manual mode activated Designation Description Radiant warmer Shows the radiant warmer power numerically and as bars. Therapy bar Shows the available modes in radiant warmer operation. In this example, manual mode is activated. Instructions for use Babyleo TN500 SW 1.0n...
Page 72 In pre-warm mode the radiant warmer power is set automatically and comprises the following 3 phases: Radiant warmer power Duration Display 100 % 3 minutes 60 % 11 minutes and 30 seconds 30 % Until the user sets a value. Instructions for use Babyleo TN500 SW 1.0n...
Page 73 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 Pre-warm mode Designation Description Shows that pre-warm mode is activated. Instructions for use Babyleo TN500 SW 1.0n...
Page 74: Transition
Radiant warmer operation Incubator operation (hood open) (hood closed) As soon as the hood is closed, the device switches automatically to incubator operation. The convection heater is already preheated before the hood is closed. Instructions for use Babyleo TN500 SW 1.0n...
Page 75 The settings for oxygen (option) and humidity are also retained. Example: The hood is opened for a few minutes to check the position of the ventilation mask. Instructions for use Babyleo TN500 SW 1.0n...
Page 76  This ensures optimum warming during and after the tran- sition. – In incubator operation the radiant warmer is switched off. – In radiant warmer operation the convection heater is switched off.  This saves energy. ✓ The transition is configured. Instructions for use Babyleo TN500 SW 1.0n...
Page 77: Skin Temperature Mode
Thermomonitoring function. For further information, see the following section: ''Thermomonitoring'' (page 83) To open the quick setup dialog window, touch a skin temperature value. The buttons for the alarm limits are displayed. Instructions for use Babyleo TN500 SW 1.0n...
Page 78 Used for setting the humidity in the patient compartment. Oxygen (option) Used for setting the oxygen concentration in the patient compartment. Mattress (option) Used for setting the mattress core tempera- ture. ClearView on Limits fogging of the hood. Instructions for use Babyleo TN500 SW 1.0n...
Page 79 If 2 skin temperature sensors are used, changes in skin temperature can be detected more quickly using the thermomonitoring function. Dräger recommends the use of original Dräger skin temperature sensors. Instructions for use Babyleo TN500 SW 1.0n...
Page 80 To activate skin temperature mode, at least the yellow skin temperature sensor for measuring the central skin temperature must be connected. 3 Pass the sensor cables into the device through a hose grommet. Instructions for use Babyleo TN500 SW 1.0n...
Page 81 – Prone position: using a sensor cover, attach the sensor to the back in the kidney region. 2 Attach the white skin temperature sensor for measuring the peripheral skin temperature to the patient's foot or hand using a sensor cover. Instructions for use Babyleo TN500 SW 1.0n...
Page 82  The patient is warmed in accordance with his or her needs.  The temperature is continuously monitored by skin temperature sensors. 8 Check the alarm limits for skin temperature and adjust them if necessary. Instructions for use Babyleo TN500 SW 1.0n...
Page 83  The Alarm limits dialog page is displayed for skin temperature mode. 2 Set and confirm the alarm limits for the tolerated deviation for the central skin temperature. ✓ The alarm limits for the central skin temperature are set. Instructions for use Babyleo TN500 SW 1.0n...
Page 84 ✓ The advanced skin temperature alarm limits are set. If one of the advanced skin temperature alarm limits is switched off, the following symbol is displayed on the main screen: The same symbol is displayed if skin temperature monitoring is deactivated. Instructions for use Babyleo TN500 SW 1.0n...
Page 85: Air Temperature Mode
The target air temperature must be at least 3 °C (5.4 °F) above the ambient temperature in order for the device to reach the desired temperature. In air temperature mode the patient's skin temperature can be monitored with skin temperature sensors. Instructions for use Babyleo TN500 SW 1.0n...
Page 86 Used for setting the humidity in the patient compartment. Oxygen (option) Used for setting the oxygen concentration in the patient compartment. Mattress (option) Used for setting the mattress core tempera- ture. ClearView on Limits fogging of the hood. Instructions for use Babyleo TN500 SW 1.0n...
Page 87 1 Touch the Air mode tab (1) in the therapy bar.  The tab turns yellow. 2 Press the rotary knob to confirm.  The tab turns dark green.  The mode is activated. Fig. 45 Starting air temperature mode Instructions for use Babyleo TN500 SW 1.0n...
Page 88 (page 84) Prerequisites: – The 2 skin temperature sensors are connected to the device and attached to the patient. – The Advanced skin temperature monitoring function is activated. Fig. 46 Skin temperature alarm limits Instructions for use Babyleo TN500 SW 1.0n...
Page 89 Upper alarm limit: +0.5 °C (0.9 °F) Lower alarm limit: -0.5 °C (0.9 °F) The automatic alarm limits relate in each case to the current skin temperature measurement or to the current difference. Instructions for use Babyleo TN500 SW 1.0n...
Page 90 1 In the therapy bar touch either the Skin mode tab or the Kangaroo mode tab.  The selected tab turns yellow. 2 Press the rotary knob to confirm.  The selected tab turns dark green. ✓ Air temperature mode is ended. Instructions for use Babyleo TN500 SW 1.0n...
Page 91: Manual Mode
Designation Description Timer Starts with radiant warmer power settings above 30 %. Limits the supply of heat to 15 minutes. Manual mode Selects manual mode. Warmer Used for setting the radiant warmer power. Instructions for use Babyleo TN500 SW 1.0n...
Page 92 Risk to patient due to increased water loss when exposed to thermal radiation The thermal radiation may cause increased water loss in the patient. ► Only expose the patient to the necessary amount of thermal radiation and only in a controlled manner. Instructions for use Babyleo TN500 SW 1.0n...
Page 93 – The skin temperature sensors are connected. – The Advanced skin temperature monitoring function is activated. For further information, see the following chapter: ''Setting the advanced skin temperature alarm limits'' (page 84) Instructions for use Babyleo TN500 SW 1.0n...
Page 94: Humidity
Using the humidification system Prerequisites: – Aquadest/distilled water for the humidification system is available in a water bag or water bottle. – The connection kit with a Luer Lock connector is ready to use. Instructions for use Babyleo TN500 SW 1.0n...
Page 95 If a high humidity level is set and the ambient temperature is low, condensation may form next to the device. This may cause the user or a third-party to slip over. Instructions for use Babyleo TN500 SW 1.0n...
Page 96: Oxygen (Option)
The table below shows the setting ranges for the supply of oxygen: Setting range Extended range Off, 21 to 40 % 41 to 65 % To set the oxygen supply in the extended range, first confirm the extended range by pressing the rotary knob. Instructions for use Babyleo TN500 SW 1.0n...
Page 97 ► Always monitor the oxygen concentration in the patient's blood, e.g., using blood gas analysis and a pulse oxymeter. ► Always monitor the external O supply. ► Be aware that Babyleo TN500 displays no alarms in the case of an external oxygen supply, e.g., via an O hood. WARNING...
Page 98 – The required oxygen concentration is set. Procedure: 1 Touch the Alarms... button (1) in the main menu bar.  The Alarm limits dialog page is displayed. Fig. 52 Alarm limits for oxygen Instructions for use Babyleo TN500 SW 1.0n...
Page 99 3 Wait for the warm-up time of the O sensors.  The remaining warm-up time is displayed in the dialog window. 4 Make sure that no oxygen is led into the patient compartment from the central supply, cylinders or external sources. Instructions for use Babyleo TN500 SW 1.0n...
Page 100: Heated Mattress (Option)
The mattress core temperature is the mean of 2 temperatures measured at the edges of the heating element. The mattress core temperature can also be influenced by other heat sources. Instructions for use Babyleo TN500 SW 1.0n...
Page 101 If the contact pins are touched, the user and the patient will be exposed to the risk of an electric shock. ► Do not touch the pins in the plug of the heated mattress. Instructions for use Babyleo TN500 SW 1.0n...
Page 102 4 Connect the orange plug of the heated mattress to the orange socket (1) on the rear of the sensor wall. Fig. 54 Connecting the heated mattress  The therapy control for the heated mattress changes to dark green. ✓ The heated mattress is connected to the device. Instructions for use Babyleo TN500 SW 1.0n...
Page 103  The device sets the mattress core temperature automatically according to the air temperature. 4 Press the rotary knob to confirm.  The therapy control turns dark green. ✓ The mattress core temperature is set. Instructions for use Babyleo TN500 SW 1.0n...
Page 104: Kangaroo Mode
Depending on the patient, kangarooing may last for several minutes or hours. When the patient is back in the device again and kangaroo mode has ended, the device resumes the warming therapy using the settings that were activated prior to kangaroo mode. Instructions for use Babyleo TN500 SW 1.0n...
Page 105 – The last settings in incubator operation have been checked: – Air temperature – Humidity – Oxygen (option) – Mattress core temperature (option) These settings are adopted in kangaroo mode. Instructions for use Babyleo TN500 SW 1.0n...
Page 106 6 Close the hood or the side access panel. Make sure that the hoses or cables do not get caught. 7 Check the alarm limits for skin temperature and adjust them if necessary. Instructions for use Babyleo TN500 SW 1.0n...
Page 107 When kangaroo mode starts, the following alarms are delayed for 4 minutes: – Humidity low – Skin temperature difference high – Skin temperature difference low – Air temperature low – Peripheral skin temperature low – Oxygen low – Central skin temperature low Instructions for use Babyleo TN500 SW 1.0n...
Page 108: Skin Temperature
6 Depending on the operating mode and the mode, check the following settings and adjust them if necessary: – Skin temperature – Air temperature – Radiant warmer power – Oxygen (option) – Humidity – Mattress core temperature (option) Instructions for use Babyleo TN500 SW 1.0n...
Page 109: Tolerate Cooling (Option)
– The patient is inside the device. Procedure: 1 Touch the Special procedures... button (1) in the main menu bar.  The Special procedures dialog window is displayed. Fig. 60 Starting Tolerate cooling Instructions for use Babyleo TN500 SW 1.0n...
Page 110 Automatic setting of alarm limits for "Tolerate cooling" In the Alarm limits dialog window, the currently measured skin temperature values are also displayed. The alarm limits can be set automatically based on the current values: Instructions for use Babyleo TN500 SW 1.0n...
Page 111: Warm-Up (Option)
The following values can be set: – Target value for central skin temperature The patient's skin temperature at the end of the warm-up time. – Temperature step The increase in skin temperature per temperature step. Instructions for use Babyleo TN500 SW 1.0n...
Page 112 5 Set and confirm the interval for the temperature steps with the rotary knob.  The value is adopted.  The calculated warm-up time is displayed. 6 Touch the On button. Instructions for use Babyleo TN500 SW 1.0n...
Page 113: Weaning (Option)
If the patient is unable to maintain the required skin temperature, the patient compartment is heated back up to the air temperature that was in effect before the last temperature reduction. An alarm is triggered. Instructions for use Babyleo TN500 SW 1.0n...
Page 114 2 Open the Weaning dialog window (2). 3 Set and confirm the target value for the air temperature with the rotary knob. 4 Set and confirm the temperature step with the rotary knob. Instructions for use Babyleo TN500 SW 1.0n...
Page 115 1 Touch the Special procedures... button in the main menu bar. 2 Open the Weaning dialog window. 3 Touch the Off button. 4 Press the rotary knob to confirm. ✓ Weaning has ended. Instructions for use Babyleo TN500 SW 1.0n...
Page 116: Scale (Option)
Shows the last measured weight. Weigh patient Activates the weighing process. Weight (NET) [g] Shows the weight after taring. Adjusted weight The symbol indicates whether the measured weight was adjusted by the user. Instructions for use Babyleo TN500 SW 1.0n...
Page 117 – The bed support is resting securely on the T-bars and is not tilted to the side. – The locking brakes are engaged. – A mattress is placed on the mattress tray. – The patient is lying in the center of the mattress. Instructions for use Babyleo TN500 SW 1.0n...
Page 118 For further information, see the following chapter: ''Adjusting the mattress tray'' (page 49)  The air bubble in the spirit level is within the black ring and is not touching the ring. Instructions for use Babyleo TN500 SW 1.0n...
Page 119  Once weighing is complete, a signal sounds.  The measuring result is displayed. The weight is also displayed as a trend. To confirm the measuring result, touch the OK button. To discard the measuring result, touch the Discard button. Instructions for use Babyleo TN500 SW 1.0n...
Page 120 1 To weigh the patient again, touch the Reweigh (1) button.  The measuring result is displayed.  The weight is also displayed as a trend. Fig. 68 Buttons after a measurement has been made Instructions for use Babyleo TN500 SW 1.0n...
Page 121 ✓ The measuring result is displayed in the dialog window. The adjusted weight values are highlighted in the graphical view and the tabular view. Only the last measured weight is displayed per day. Fig. 69 Adjusting the measured patient weight Instructions for use Babyleo TN500 SW 1.0n...
Page 122: Taking X-Rays
If the ambient conditions (temperature and relative humidity) in the device are unsuitable for a digital x-ray detector, the x-ray detector may provide incorrect results. ► Observe the permitted temperature range for the digital x-ray detector. Instructions for use Babyleo TN500 SW 1.0n...
Page 123 5 Use the light field of the x-ray device to set the aperture to determine the desired image section. 6 X-ray the patient. 7 Take the image receiver out of the x-ray tray and read it. ✓ The patient's x-ray is available. Instructions for use Babyleo TN500 SW 1.0n...
Page 124: Developmental Care (Option)
Developmental care view and in the Trends/data dialog window as follows: – If the medium threshold is exceeded, the graph turns yellow. – If the upper threshold is exceeded, the graph turns red. Instructions for use Babyleo TN500 SW 1.0n...
Page 125 3 Use the rotary knob to set and confirm the thresholds for the noise level and the light level. ✓ The monitoring limits for noise and light are set. The monitoring limits for noise and light are only indicated visually. There is no acoustic signal. Instructions for use Babyleo TN500 SW 1.0n...
Page 126 A phototherapy light can then be placed above the device. The hood cover can only be used during incubator operation. Observe the separate instructions for use for the hood cover. Instructions for use Babyleo TN500 SW 1.0n...
Page 127: Alarms
4 minutes. Only a visual alarm is displayed. If during this time an alarm occurs which is unforeseeable, then the suppression is canceled and the alarm signal sounds. Instructions for use Babyleo TN500 SW 1.0n...
Page 128 Fan motor faulty, heating off Humidity low max. 60 Internal temperature high Mattress faulty Mattress temperature too high Oxygen high max. 30 Oxygen low max. 10 Oxygen module faulty Oxygen sensor faulty Peripheral skin temp. sensor faulty Instructions for use Babyleo TN500 SW 1.0n...
Page 129 ✓ In the header bar, the symbol and the remaining time for the suppressed alarm signal are displayed. 7.2.1 Premature reactivation of the alarm signal 1 Press the "Audio paused" key. ✓ The symbol for the suppressed alarm signal is no longer displayed in the header bar. Instructions for use Babyleo TN500 SW 1.0n...
Page 130: Dismissing The Alarm Message
When the device is shut down, the alarm history is deleted. There is no record kept of how long the device and alarm system were shut down. The alarm history is also deleted in the event of a power supply failure. Instructions for use Babyleo TN500 SW 1.0n...
Page 131: Configuration
 The keyboard is displayed. Fig. 74 Keyboard Sauer PJ, Dane HJ, Visser HK. New standards for neutral thermal environment of healthy very low birth weight infants in week one of life. 1984 Instructions for use Babyleo TN500 SW 1.0n...
Page 132  The existing patient data is deleted.  The therapy settings and the patient-specific alarm settings are reset to the user-specific settings.  The logbook is not deleted. ✓ Patient data can be entered anew. Instructions for use Babyleo TN500 SW 1.0n...
Page 133 8 Press the rotary knob to confirm. ✓ The air temperature is set. Sauer PJ, Dane HJ, Visser HK. New standards for neutral thermal environment of healthy very low birth weight infants in week one of life.1984 Instructions for use Babyleo TN500 SW 1.0n...
Page 134: Transferring Data To Another Device
Current settings, which have been determined using the ther- apy controls, e.g., with the therapy control for air temperature, skin temperature, air humidity, mattress core temperature Current settings in Alarms The trend data and the logbook data cannot be exported. Instructions for use Babyleo TN500 SW 1.0n...
Page 135 It may take a few seconds for the device to recognize the USB mass storage device. 2 Touch the System setup... button (3) in the main menu bar. Fig. 76 Import/export dialog window of patient data Instructions for use Babyleo TN500 SW 1.0n...
Page 136  Once the import is complete, the device restarts automatically. 5 Touch the Configuration data tab. 6 Enter the password and confirm.  The exported data records are displayed with date and time in the Configuration data dialog window. Instructions for use Babyleo TN500 SW 1.0n...
Page 137: Displaying Trends And Data
– The device is in operation. Procedure: 1 Touch the Trends/data... button (1) in the main menu bar. Fig. 77 Trends/data dialog window 2 Touch the Graphical trends, Tabular trends, Values/settings, or Logbook tab. Instructions for use Babyleo TN500 SW 1.0n...
Page 138: Humidity
– Temperature and patient compartment – Temperature and heating – Patient compartment and heating Fig. 78 Configuration menu of displayed thermoregulation parameters To change the overviews, touch the pen icon (1). Instructions for use Babyleo TN500 SW 1.0n...
Page 139 Mattress core temperature – Patient compart- Humidity – ment Oxygen – Heating Radiant warmer Convection heater Events Hood open Access panel open Air mode – Manual mode – Skin mode – Kangaroo mode Instructions for use Babyleo TN500 SW 1.0n...
Page 140 Peripheral skin tempera- ture Skin temperature differ- ence Air temperature Mattress core tempera- ture Patient com- Humidity partment Oxygen – Heating Radiant warmer – Convection heater – Weight Noise/light Noise level Light level Instructions for use Babyleo TN500 SW 1.0n...
Page 141 – Therapy control changes – Start and end of applications – Events such as hood open, side access panel open – Data import and export to USB mass storage device – Device time changes Instructions for use Babyleo TN500 SW 1.0n...
Page 142: System Setup
Resetting to factory settings Certain tabs in the System setup dialog window have a button for resetting the user-specific settings to the factory settings. 1 Open the relevant tab, e.g., Screen layout, Alarms, Therapy, System. Instructions for use Babyleo TN500 SW 1.0n...
Page 143 Switch the automatic screen lock on or off. Lock after Select when the screen should 30 s be automatically locked follow- ing a period of inactivity: 30 s, 1 min, 5 min, 15 min, 30 min. Instructions for use Babyleo TN500 SW 1.0n...
Page 144 – The upper alarm limit for 5 °C (9 °F) the difference between the central and peripheral skin temperature – The lower alarm limit for the difference between the cen- tral and peripheral skin tem- perature Instructions for use Babyleo TN500 SW 1.0n...
Page 145 35 °C (95 °F) the central skin temperature – The lower alarm limit for the 30 °C (86 °F) central skin temperature – The upper and lower alarm limit for the peripheral skin temperature Instructions for use Babyleo TN500 SW 1.0n...
Page 146 – In radiant warmer opera- tion the convection heater is switched off. ClearView Switch on so that the radiant warmer operates at low power and reduces the level of fog- ging on the hood. Instructions for use Babyleo TN500 SW 1.0n...
Page 147 Country Enter and confirm the configu- ration password. Language Select a language. Date/time Set the date and time and con- firm with the rotary knob. Then confirm with the Apply button. Instructions for use Babyleo TN500 SW 1.0n...
Page 148 Start level for alarm Set the start level for the alarm 50 % volume [%] volume as a percentage. Maximum alarm Set the maximum alarm vol- 70 % volume [%] ume as a percentage. Instructions for use Babyleo TN500 SW 1.0n...
Page 149 DrägerService) – Adjusting the scale (option) For more information, contact DrägerService. Maintenance notifi- Switch the display of mainte- cation nance messages on or off. Password Change the configuration password. Instructions for use Babyleo TN500 SW 1.0n...
Page 150: Transfer
► During the transfer, monitor the patient's body temperature with a separate measuring device. ► Make sure that the patient is sufficiently warmed during the transfer. Instructions for use Babyleo TN500 SW 1.0n...
Page 151 5 Remove the x-ray cassette from the x-ray tray. Slide the x-ray tray into the device. 6 Slide the bed support into the device. 7 Slide the drawer into the device and lock the drawer. Instructions for use Babyleo TN500 SW 1.0n...
Page 152 12 Remove all plugs and the mains plug. Fasten the power cable to the device. ✓ The device is ready for transfer. Check for operational readiness after the transfer. For further information, see the following chapter: ''Checking for operational readiness'' (page 63) Instructions for use Babyleo TN500 SW 1.0n...
Page 153: Troubleshooting
!! 217 Air temperature too high The maximum allowed air Remove external heat temperature has been sources. exceeded. Contact specialized service personnel. Instructions for use Babyleo TN500 SW 1.0n...
Page 154: Ambient Temperature Sensor
The current central skin tem- Check the settings. too high perature is above 39.5 °C Check the patient's condition. (103.1 °F). Make sure that the sensor is correctly attached to the patient. Remove external heat sources. Instructions for use Babyleo TN500 SW 1.0n...
Page 155: Device Failure, Heating Off
Put the device out of opera- tion. Contact specialized service personnel. !! 68 Fan faulty The fan impeller is not Switch off the device and installed. check the fan impeller. The fan is faulty. Contact specialized service personnel. Instructions for use Babyleo TN500 SW 1.0n...
Page 156: Fan Motor Faulty, Heating Off
Contact specialized service val has been exceeded. personnel. !! 61 Manual mode not con- The mode was selected, but Select manual mode and firmed it was not confirmed. press the rotary knob to con- firm. Instructions for use Babyleo TN500 SW 1.0n...
Page 157: Mattress Faulty
Remove the obstacle. blocked by an obstacle. An internal fault occurred. Contact specialized service personnel. !! 216 Oxygen high The current oxygen concen- Check the set value. tration is above the set value. Instructions for use Babyleo TN500 SW 1.0n...
Page 158: Oxygen Low
The current peripheral skin Check the settings. ture too high temperature is above 39.5 °C Check the patient's condition. (103.1 °F). Make sure that the sensor is correctly attached to the patient. Remove external heat sources. Instructions for use Babyleo TN500 SW 1.0n...
Page 159: Skin Temp. Sensor Faulty, Heating
Check the settings. central skin temperature (yel- Check the patient's condition. low) has been exceeded. Make sure that the sensor is The current central skin tem- correctly attached to the perature is too high. patient. Instructions for use Babyleo TN500 SW 1.0n...
Page 160: Skin Temperature Low
Refill the water supply. Weaning completed The set target value for Check the settings and adjust weaning is reached. them if applicable. Remove the patient from the device. Instructions for use Babyleo TN500 SW 1.0n...
Page 161: Power Failure Alarm
The mains power supply Restore the mains power has failed. supply. When the mains power supply is restored, the device continues the warming therapy with the settings that were activated before the power supply failure. Instructions for use Babyleo TN500 SW 1.0n...
Page 162: Adjustment Of Device Height Not Possible
Check scale. scale. rectly plugged in. Repeat the weighing process. If weighing is still not possi- ble, contact specialized service personnel. Instructions for use Babyleo TN500 SW 1.0n...
Page 163: Fault With The Oxygen Supply
Restart the device. If the manently displayed. fault persists, turn off the oxygen supply to the patient compartment. Dräger recommends that the device not be operated with a permanent oxygen overpressure. Instructions for use Babyleo TN500 SW 1.0n...
Page 164: Removing Liquid From The Heating Plate
12 If the liquid level reaches the upper edge of the fan impeller receptacle (1), contact the specialized service personnel. The specialized service personnel must check if liquid has penetrated into the device. Instructions for use Babyleo TN500 SW 1.0n...
Page 165 Troubleshooting Fig. 82 Fan impeller receptacle 13 All liquid must be removed from the heating plate before the device is moved. Instructions for use Babyleo TN500 SW 1.0n...
Page 166: Reprocessing
2 Open the hood. 3 Touch the Special procedures... button (2) in the main menu bar.  The Special procedures dialog window is displayed. Fig. 83 Starting humidifier cleaning 4 Open the Humidifier cleaning tab (1). Instructions for use Babyleo TN500 SW 1.0n...
Page 167: Dismantling
This chapter describes how to disassemble the device before reprocessing. Only disassemble the device after the patient and all items have been removed from the device. All additional devices and accessories must be removed before reprocessing. Instructions for use Babyleo TN500 SW 1.0n...
Page 168 Hood sealings Side access panels and front access panel Drawer insert (option) Hose grommets Fan impeller Small and large warm air duct cover T-bars Bed support with scale (option) X-ray tray Mattress tray Instructions for use Babyleo TN500 SW 1.0n...
Page 169 – Sensor wall: 3 pieces, on each corner and in the middle of the sensor wall – Front access panel: 3 pieces, on each corner and in the middle of the front access panel Instructions for use Babyleo TN500 SW 1.0n...
Page 170 7 Open the X-ray flaps on both sides. Pull out the x-ray tray as far as it will go, lift it slightly and then pull it out completely. 8 Remove the bed support. 9 Remove the T-bars. Instructions for use Babyleo TN500 SW 1.0n...
Page 171: Information On Reprocessing
ISO 17664 standard. Reprocessing must be 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 respective reprocessing procedure. Instructions for use Babyleo TN500 SW 1.0n...
Page 172: Classification For Reprocessing
Surface disinfection using the following surface disinfectant is suitable for the device and all components (non-critical and semi-critical): Class of active Product name Manufacturer Contact Concentra- ingredient time tion Oxygen-releasing Dismozon plus BODE Chemie 15 min 1,6 % agents Instructions for use Babyleo TN500 SW 1.0n...
Page 173 Ecolab USA Perform Schülke & Mayr Virkon DuPont Quaternary ammonium Schülke & Mayr Mikrozid sensitive liquid compounds Mikrozid alcohol free liquid Mikrozid sensitive wipes Mikrozid alcohol free wipes acryl-des 1) Virucidal against enveloped viruses Instructions for use Babyleo TN500 SW 1.0n...
Page 174: Surface Disinfection With Cleaning
The cleaning and surface disinfection of individual parts demands particular care. All sides of every part must be thoroughly cleaned and disinfected. Examples: – Hood and hood seal – Side panels and hand ports – Air ducts of the X-ray flap Instructions for use Babyleo TN500 SW 1.0n...
Page 175 3 After the contact time has elapsed, remove residual disinfectant. 4 Check the product for visible soiling. Repeat steps 1 to 4 if necessary. 5 Check the product for visible damage and replace it if necessary. Instructions for use Babyleo TN500 SW 1.0n...
Page 176: Additional Reprocessing Measures
Cleaning and disinfecting can cause components to wear, resulting in device malfunctions. There is a risk of injury. ► Check the device and reusable products for signs of wear (e.g., cracks, deformation, discoloration, or detachment) and replace if necessary. Instructions for use Babyleo TN500 SW 1.0n...
Page 177 3 Insert the small cover for the warm air duct. 4 Attach the T-bars. 5 Place the bed support on the T-bars from above. 6 Slide in the x-ray tray and close the x-ray flaps. Instructions for use Babyleo TN500 SW 1.0n...
Page 178 Check that the hose grommets are correctly seated. 11 Fold the side access panels and the front access panel upward. Make sure that all access panels latch securely in place. Instructions for use Babyleo TN500 SW 1.0n...
Page 179 1 Assemble and prepare the device so it is ready for operation. For 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'' (page 63). Instructions for use Babyleo TN500 SW 1.0n...
Page 180: Service
Federal Republic of Austria 12.2.1 Remote Service The device supports the following Remote Service functions: – Help Ticket – Device Check For more information about the Remote Service function, contact DrägerService. Instructions for use Babyleo TN500 SW 1.0n...
Page 181 Risk of patient injury due to service measures performed during therapy Performing service measures during therapy may endanger the patient. ► Only perform service measures when there is no patient in the device. Instructions for use Babyleo TN500 SW 1.0n...
Page 182 – Check of the incubator temperature according to standard IEC 60601-2-19, sentence 201.12.1.105 – Functional integrity of the acoustic alarm generator – Functional integrity of the mains supply failure alarm – Display of the optical alarm signals Instructions for use Babyleo TN500 SW 1.0n...
Page 183 – Simulation resistors are connected instead of the skin temperature sensors. The simulation resistors must maintain the following values: Resistance Temperature 1586 Ω 33.2 °C (91.8 °F) 1412 Ω 36.0 °C (96.8 °F) 1312 Ω 37.8 °C (100.0 °F) Instructions for use Babyleo TN500 SW 1.0n...
Page 184: Maintenance
Soft- Bed mattress are damaged. Filter cloth (in the sensor Every 6 months Replace, see Users wall) page 185 Oxycell O sensors Every 2 weeks Adjustment Users Every 24 months Replace Service personnel Instructions for use Babyleo TN500 SW 1.0n...
Page 185: Replacing The Filter Cloth For Patient Air In The Sensor Wall
2 In the System setup dialog window, open the System>Service dialog page. 3 Enter the password and confirm. 4 Touch the Service menu button and confirm. ✓ The Service dialog window is displayed. Instructions for use Babyleo TN500 SW 1.0n...
Page 186 The licensed applications must be activated before they become available. 1 Select the corresponding license from the list. 2 Touch the Activate (Activate) button. 3 After activating all desired licenses, restart the device. Instructions for use Babyleo TN500 SW 1.0n...
Page 187: Disposal
This device must be disposed of in accordance with national regulations. In countries of the European Union, Dräger will organize the return of the device. Additional information is available at www.draeger.com (search term: WEEE). Instructions for use Babyleo TN500 SW 1.0n...
Page 188: Technical Data
1850 to 2250 mm (72.83 to 88.58 in) Height of the mattress surface 700 to 1100 mm (27.56 to 43.31 in) Mattress area 450 mm x 690 mm (17.72 in x 27.17 in) Instructions for use Babyleo TN500 SW 1.0n...
Page 189: 14.3 Performance Characteristics
Alarm volume Setting range for high- and medium-priority 50 dB(A) to 70 dB(A) alarms Measured in accordance with IEC 60601-2-19 and IEC 60601-2-21 Power failure alarm Alarm volume 65 dB(A) Duration 10 minutes Instructions for use Babyleo TN500 SW 1.0n...
Page 190: 14.4 Measured Value Display
13 to 43 °C (55.4 to 109.4 °F) Sensor Only use original Dräger skin temperature sen- sors. Measurement uncertainty (sensors) ± 0.1 °C (0.18 °F) Measurement uncertainty (entire system) ±0.3 °C (0.54 °F) Instructions for use Babyleo TN500 SW 1.0n...
Page 191 0 to 2500 g (0 to 5.5 lb): 2.5 g (0.0055 lb) for loads over 2500 g (5.5 to 22 lb): 5 g (0.011 lb) Resolution (OIML version) 5 g (0.011 lb) Resolution (standard version) 1 g (1 oz) Instructions for use Babyleo TN500 SW 1.0n...
Page 192: 14.5 Materials
60 V DC nominal volt- age. Type 9-pole D-sub, electrically isolated: 1.5 kV against internal electronics 1.0 kV against housing Protocol MEDIBUS.X Alarm delay Typically < 2 s Baud rate 1200, 2400, 4800, 9600, 19200, 38400 baud Instructions for use Babyleo TN500 SW 1.0n...
Page 193 IEC 60950-1 on unearthed SELV circuits or the requirements of the standard IEC 60601-1 on accessible sec- ondary circuits with max. 60 V DC nominal volt- age. Type 3.5 mm (0.14 in) jack plug Instructions for use Babyleo TN500 SW 1.0n...
Page 194: Device Combinations
Examples of subsequent changes to the network: – Changing the network configuration – Removing devices from the network – Adding new devices to the network – Performing upgrades or updates on devices that are connected to the network Instructions for use Babyleo TN500 SW 1.0n...
Page 195 – Alarms or data are delayed. – False alarms are indicated. – During an interruption of the network connection: – Alarms are not transmitted. – Suppressed alarms or alarm tones are not reactivated, but remain suppressed. Instructions for use Babyleo TN500 SW 1.0n...
Page 196: Emc Declaration
2.4 GHz will likely cause difficulty with the networking components. Low-level signals such as ECG signals are particularly susceptible to interference from electromagnetic energy. Even if the equipment meets the test requirements Instructions for use Babyleo TN500 SW 1.0n...
Page 197 (IEC 61000-3- 14.9.4 Electromagnetic immunity The medical device is intended for use in an electromagnetic environment as specified below. The user must make sure that the medical device is used in such an environment. Instructions for use Babyleo TN500 SW 1.0n...
Page 198 150 kHz to 2.5 GHz and less than 1 V/m above 2.5 GHz. 2) ISM bands in this frequency range are: 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; 40.66 MHz to 40.70 MHz. Instructions for use Babyleo TN500 SW 1.0n...
Page 199: Open-Source Software
Dräger devices that use software may use open-source software, depending on their setup. Open-source software may be subject to different terms of license. Additional information regarding the open-source software used in this device is available at the following web page: www.draeger.com/opensource Instructions for use Babyleo TN500 SW 1.0n...
Page 200: Annex
The radiant warmer power increases and the patient receives more heat. If the defined set value is lower than the measured value (skin too warm), the radiant warmer receives a signal to decrease the heat. Instructions for use Babyleo TN500 SW 1.0n...
Page 201: Further Information On Heated Mattress (Option)
Radiant warmer operation In radiant warmer operation, the surface temperature of the mattress tray may be higher than the displayed mattress core temperature due to the influence of the radiant warmer. Instructions for use Babyleo TN500 SW 1.0n...
Page 202: Automatic Selftest
Sensor box Water valve For the 1st use Fan impeller: – Installed – Rotational speed Safety function of heated mattress All sensors Scale Automatic Device height adjustment When used Bed-tilt mechanism When used Instructions for use Babyleo TN500 SW 1.0n...
Page 203: Delay Of The Alarm Condition
The acoustic alarm signals described here will be output by a reserve loudspeaker if the main loudspeaker should fail. The reserve loudspeaker plays the tone sequences of the Warning and Caution alarm priorities at the same tone frequency and volume level. Instructions for use Babyleo TN500 SW 1.0n...
Page 204: Interfaces
PC for servicing purposes Audio interface Interface Description Devices Audio connector (option) For connecting an audio E.g., MP3 player, CD cable for an external play- player, cassette recorder, back device cellular phone Instructions for use Babyleo TN500 SW 1.0n...
Page 205: Abbreviations
Ounce Parts per million RFID Radio Frequency Identification, radio frequency identification Revision index SNMP Simple Network Management Protocol UMDNS Universal Medical Device Nomenclature System, nomenclature for medical devices Universal Serial Bus, computer interface Instructions for use Babyleo TN500 SW 1.0n...
Page 206: Symbols
No oxygen cylinders on this side of the device Potential equalization connector Do not cover the ventilation slots of the radiant warmer. Warning: Hot surfaces Warning: Risk of crushing of feet Serial number Revision index Part number Lot number Instructions for use Babyleo TN500 SW 1.0n...
Page 207 Do not lay the patient on this side of the heated mattress Do not fold the heated mattress Do not place any sharp objects on the heated mattress Keep sources of oxygen away from the ventilation slot Working light Instructions for use Babyleo TN500 SW 1.0n...
Page 208 Annex Symbol Explanation Night light Move the device downwards Move the device upwards Instructions for use Babyleo TN500 SW 1.0n...
Page 209: Symbol In The Software
Upper alarm limit Lower alarm limit Locked Unlocked Closes the dialog window In lists: One line up In lists: One line down In lists: One page up In lists: One page down Enter key Instructions for use Babyleo TN500 SW 1.0n...
Page 210: Product Labels
Seal for the scale Audio port Explanation Socket for the audio port Oxygen connector Explanation Connectors for oxygen (oxygen cylinder or wall terminal unit) Intrahospital patient transfer Explanation Maximum permissible transfer height exceeded Instructions for use Babyleo TN500 SW 1.0n...
Page 211 Socket for the humidification system (use Aquadest/distilled water) Castor Explanation Green arrow: castor is movable in longi- tudinal direction (direction lock) Green lock: castor is not locked (no direction lock) Red lock: castor is locked Instructions for use Babyleo TN500 SW 1.0n...
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Page 213: Password
Password Password 16.1 Configuration password for Babyleo TN500 Software 1.0n Cut out from the instructions for use Babyleo TN500 Software 1.0n To prevent unauthorized alteration, the device settings for Babyleo TN500 are protected by the following configuration password: 0000 16.1.1...
Page 214 This page has been left blank intentionally. Instructions for use Babyleo TN500 SW 1.0n...
Page 215: Index
Schematic representation ... . 203 Configuration ......131 Instructions for use Babyleo TN500 SW 1.0n...
Page 216 Components ..... . 169 Device......167 Instructions for use Babyleo TN500 SW 1.0n...
Page 217 Safety instruction ....12 Starting ......105 Instructions for use Babyleo TN500 SW 1.0n...
Page 218 Safety-related information ....8 Performance characteristics ....9 Instructions for use Babyleo TN500 SW 1.0n...
Page 219 Description ..... . . 200 Patient data ..... . 134 Instructions for use Babyleo TN500 SW 1.0n...
Page 220 X-ray ......122 X-rays Taking ......122 Instructions for use Babyleo TN500 SW 1.0n...
Page 221 This page has been left blank intentionally. Instructions for use Babyleo TN500 SW 1.0n...
Page 222 These instructions for use are provided for customer information only and are only updated or exchanged upon customer request. Directive 93/42/EEC concerning medical devices Manufacturer Drägerwerk AG & Co. KGaA Moislinger Allee 53 – 55 D-23542 Lübeck Germany +49 451 8 82-0 +49 451 8 82-2080 http://www.draeger.com Á9054863gÈ...

Dräger Babyleo TN500 Instructions For Use Manual

Table of Contents

1 Information about this Document

2 Safety-Related Information

3 Product Description

Frequently Used Functions

4 Operating Concept

5 Assembly and Preparation

6 Operation

7 Alarms

Alarm

8 Configuration

9 Transfer

10 Troubleshooting

11 Reprocessing

12 Service

13 Disposal

14 Technical Data

15 Annex

16 Password

Index

Quick Links

Chapters

Related Manuals for Dräger Babyleo TN500

Summary of Contents for Dräger Babyleo TN500

Table of Contents