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Dräger Babytherm 8004 Instructions For Use Manual

Open intensive care, resuscitation.
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Babytherm
WARNING
For a full understanding of the perform-
ance characteristics of this medical
device, the user should carefully read
these Instructions for Use before use of
the medical device.
8004/8010
®
Open Intensive Care, Resuscitation
Instructions for Use

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Table of Contents

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   Summary of Contents for Dräger Babytherm 8004

  • Page 1 Babytherm 8004/8010 ® Open Intensive Care, Resuscitation WARNING For a full understanding of the perform- Instructions for Use ance characteristics of this medical device, the user should carefully read these Instructions for Use before use of the medical device.
  • Page 2: Definitions

    Definitions WARNING A WARNING statement provides important information about a potentially hazardous situation which, if not avoided, could result in death or serious injury. CAUTION A CAUTION statement provides important information about a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or in damage to the equipment or other property.
  • Page 3: Table Of Contents

    Contents Contents Definitions ........2 ThermoMonitoring .
  • Page 4: For Your Safety And That Of Your Patients

    For Your Safety and that of Your Patients For Your Safety and that of Your Patients Strictly follow these Instructions for Use Patient safety The design of the equipment, the accompanying literature, WARNING and the labeling on the equipment take into consideration that Strictly follow these Instructions for Use.
  • Page 5: General Warnings And Cautions

    For Your Safety and that of Your Patients General WARNINGS and CAUTIONS The following WARNINGS and CAUTIONS apply to general operation of the device. WARNINGS and CAUTIONS specific to subsystems or particular features appear with those topics in later sections of the manual. Note on EMC/ESD risk for the device function General information on electromagnetic compatibility (EMC) pursuant to international EMC standard IEC 60601-1-2: 2001...
  • Page 6: Intended Use

    Intended Use Intended Use Babytherm 8004/8010 is an open care unit for warming pre- mature babies, neonates and infants with a body weight of up to 8 kg. The unit may be used in operating theatres, neonatal wards, children’s wards, obstetric units and paediatric intensive care units.
  • Page 7 Intended Use Babytherm 8004 Babytherm 8010 Babytherm 8004 Babytherm 8010 °C °C °C Check Check > 38 °C Inop. Inop. <36 °C skin °C manual skin °C manual matress °C skin skin man. man.
  • Page 8: Operating Concept

    Operating Concept Operating Concept ➇ ➆ ➈ Babytherm 8010 ➅ ➄ °C °C ➃ Check > 38 °C ➂ Inop. < 36 °C skin °C manual mattress.°C skin man. ➁ ➀ ➉ ➈ ➀ Display and keypad for the radiant warmer: ON/OFF indicator: top: display for the measured value of the core and periph- The green LED is lit when the unit is ON.
  • Page 9: Preparation

    Preparation Preparation Use of accessories WARNING Stability may be impaired by the attachment of additional accessories/loads. In order to ensure stability (EN 60601-2-21), a one-sided accessory load of 25 Nm* must not be exceeded, when tilted at 10°. 1 Stand column 2 Shelf 3 Base plate 4 Swivel cabinet...
  • Page 10: Maximum Loading

    Preparation When attaching one-sided stand column accessories without swivel cabinets Maximum permissible one-sided accessory load on the stand column: – 4 kg at a height of 200 cm and at a distance of 20 cm When attaching swivel cabinets and stand column accessories on the same side For one-sided mounting of the swivel cabinet (2M20638) Maximum permissible one-sided accessory load on the stand...
  • Page 11: Shelf

    Preparation Shelf The unit is fitted with one shelf. Make sure that the shelf is firmly in position. To fit rails to the shelf: 1 Screw rail to the left and/or right of the shelf. Place desired auxiliary equipment on the rails and shelf. ●...
  • Page 12: X-ray Tray

    Preparation X-ray tray Babytherm 8004 only NOTE Do not use the X-ray tray in the extended position to rest on while writing. Do not place objects other than X-ray plate. Do not lean on the tray. Risk of damage. Preparation 1 Push X-ray tray fully home in the horizontal position.
  • Page 13: Warming Bed

    Preparation Warming bed The bed is enclosed by two side panels and two end panels that can be opened independently of one another. The side panels are provided with holes for secretion and drainage hoses. The end panels have flexible grommets for hoses and cables. Fitting the panels 1 Insert the lower mounting pins of the panel hinge-pieces into the guide slots on either side.
  • Page 14: Tilting The Bed

    Preparation Tilting the bed 1 Pull the handle of the locking mechanism out towards the front. 2 Press handle down = head-up position. Pull handle up = head-down position. Release the handle: the bed automatically locks into the ● selected position. The bed can be tilted in finely graduated steps.
  • Page 15: Bronchial Aspirator

    Preparation Bronchial aspirator Fastening the ejector on the compact rail Fit the compact rail to the desired position on the stand, ● see page 11. 1 Clip the ejector to the compact rail. 2 Mount bracket with projecting support to one of the posi- tions provided on the column.
  • Page 16: Accessories For Oxygen Therapy

    Preparation Accessories for oxygen therapy flowmeter Prepare the flowmeter in accordance with its specific ● Instructions for Use. To mount the flowmeter on the compact rail: 1 Press the slider all the way down; hook the flowmeter to the compact rail and release the slider. 2 Screw on the O connecting hose.
  • Page 17: Fitting The Hose Bracket

    Preparation Fitting the hose bracket Insert the hose bracket into the hole in the left side of the ● head panel and tighten with knurled screw. Drainage canister hook 1 Insert hook horizontally into hole in the Babytherm casing. 2 Pivot hook downwards. Compressed air distributor/socket strip ●...
  • Page 18: Testing Readiness For Operation

    Testing Readiness for Operation Testing Readiness for Operation Before using for the first time 1 Check that the mains voltage matches the values indicated on the rating plate next to the power cable. 2 Plug into the mains. ® Scale-Tronix 4002-BT NOTE To safeguard during transport, the weighing unit inside...
  • Page 19: Checking Height Adjustment (optional)

    Testing Readiness for Operation Checking height adjustment (optional) Test height adjustment system if fitted: 1 Press the right pedal briefly to raise the bed. 2 Press the left pedal briefly to lower the bed. Remember the maximum load for height adjustment is ●...
  • Page 20: Checking Leds, Displays And Audible Alarm

    Testing Readiness for Operation Checking LEDs, displays and audible alarm 1 Press the key. Check Babytherm 8010 2 The following message appears in the display: »All displays on, horn on«. All the displays are lit for about 2 seconds: digital displays read »88.8« and a continuous tone sounds. 15 min 2 The following message appears in the display: »All displays off, soft alarm on«.
  • Page 21: Operation

    Operation Operation Mattress heater WARNING In the Babytherm 8004, use foam mattresses Precautions (e.g. SoftBed) only, do not use gel mattresses. Risk of hypothermia. Patient care In the Babytherm 8010 use gel matresses only, do not WARNING use foam matresses.
  • Page 22 Operation Bed canopy WARNING The infant’s core temperature should be monitored when Do not use the baby control mode for infants in a state the bed canopy is in use. of shock. CAUTION When in shock, skin temperature is much lower than The effect of the radiant warmer is reduced when the bed normal.
  • Page 23: Switching On

    Operation Switching on After switching on, the system runs a self-test and then pro- poses the following default operating mode for the radiant Babytherm 8010 warmer: – if no skin temperature sensors connected = »man.« (manual) 15 min – if yellow skin temperature sensor for core temperature is connected = »skin«...
  • Page 24: 15 Minutes Alarm

    Operation 15 minutes alarm To remind the user to monitor the core temperature con- stantly at higher heater output levels, – an audible alarm is emitted every 15 minutes at heater level 4 and above. At the same time: 1 the yellow LED flashes. –...
  • Page 25: Using Baby Control Mode

    Operation Using baby control mode WARNING In this operating mode, the skin temperature of the infant is If the yellow skin temperature sensor becomes adjusted towards the set value. The sensor attached to the detached, it will measure the air temperature and so the skin measures the skin temperature.
  • Page 26 Operation For single use: – Only use Dräger approved skin temperature sensors. NOTE Only use Dräger ThermoPads . Using other types of adhe- sive pads may result in incorrect temperature measure- ments and therefore can affect the safety and effectiveness of the skin temperature measurement.
  • Page 27 Operation Deviations of a few tenths of a degree are normal. NOTE Therefore: Only change the set value for the skin temperature if the core temperature needs to be corrected. Check, whether both infrared radiators are providing warmth, by placing your hand carefully at a safe distance from the radiant heater.
  • Page 28 Operation For deviations greater than ±0.5 °C between the set and measured skin temperature: 1 The skin temperature display starts flashing. – An audible alarm sounds, Babytherm 8010 2 the yellow LED starts flashing and – the red central alarm lamp on the radiant warmer starts to flash.
  • Page 29 Operation Skin temperature above 39 °C 1 The skin temperature display starts flashing. – The audible alarm sounds. Babytherm 8010 2 the red LED starts flashing. – The red central alarm lamp on the radiant warmer starts to flash. 15 min 3 The following message appears in the text display: »Skin temperature above 39 °C <...
  • Page 30: Thermomonitoring

    Operation ThermoMonitoring For improved feedback on the thermal condition of the patient, we recommend that both the core and the peripheral temperature should be measured. Connecting the peripheral skin temperature sensor 1 Plug the white sensor fully into the white socket. 2 Route the sensor cable through one of the flexible grom- mets in the bed.
  • Page 31: Using Heated Gel Mattress

    Operation Using heated gel mattress Observe the warm-up time of the gel mattress. Wait until the desired mattress heating value is reached before placing the infant in the Babytherm 8010. Do not switch off the mattress heater while an infant is lying on the gel mattress.
  • Page 32 Operation Extending lower limit of the setting range 36 °C to 30 °C Only use low temperatures if prescribed by doctor. Monitor patient very closely. 1 Press button until 2 the set value »36 °C« is displayed. Babytherm 8010 3 The following message appears in the text display: »Mattress temperature Confirm temp.
  • Page 33 Operation Deviation from set temperature If the deviation between the set and measured mattress tem- perature is greater than ±1 °C: – The audible alarm sounds, 1 the yellow LED starts flashing and Babytherm 8010 – the red central alarm lamp on the radiant warmer flashes. 2 Measured mattress temperature value flashes, 3 The following message appears in the text display: 15 min...
  • Page 34 Operation Mattress temperature above 40 °C 1 Red LED flashes. – The red central alarm lamp on the radiant warmer starts to Babytherm 8010 flash. 2 Display flashes. 3 The following message appears in the text display: 15 min »Mattress temp. above 40 °C Press OK button to acknowledge«.
  • Page 35: Using The Bed Canopy

    Operation Using the bed canopy The infant’s core temperature should be monitored when the bed canopy is in use. CAUTION The effect of the radiant warmer is reduced when the bed canopy is in use. The patient's core temperature should be monitored in order to prevent adverse effects on the temper- ature balance.
  • Page 36 Operation Opening/closing the bed canopy 1 Unlock bed canopy = turn lock 2 Open bed canopy = swivel handles upwards until they engage. The infant is now accessible for care/medical treatment. 2 Close bed canopy = swivel handles forwards. Removing the bed canopy 3 Put bed canopy in closed position = turn lock until it engages.
  • Page 37: Recommended Heater Settings For Heat Therapy

    Operation Recommended heater settings for heat therapy Instructions for setting the mattress heater and radiant warmer, alone or in combination. Using the mattress heater with a gel mattress without using the radiant warmer (Babytherm 8010 only) Normal setting: The core temperature of the patient adapts to the mattress temperature over a relatively long period.
  • Page 38 Do not cover or dress the patient. Otherwise, the effect of ● the radiant warmer is uncontrollably reduced. Radiant warmer without mattress heater Babytherm 8004 1 Use foam mattress. Do not use a gel mattress when oper- ating without mattress heating. WARNING...
  • Page 39 Operation Using radiant warmer in combination with mattress heater and gel mattress (Babytherm 8010 only) Normal setting: Set the mattress temperature to the core temperature appro- priate for the patient, e.g. between 38.0 °C and 38.3 °C for a premature baby and 37.0 °C for a neonate born after the nor- mal term.
  • Page 40: Using Phototherapy (optional)

    Operation Using phototherapy (optional) In manual mode, reduce the heat output of the radiant WARNING warmer. The phototherapy light directs additional warmth to Only use the phototherapy lamps indicated, the patient. see "Technical Data", page 66. Using lights of other CAUTION types can affect the safety and effectiveness of the Monitor the patient’s core temperature regularly using a...
  • Page 41 Operation Switching on 1 Press button. The yellow LED in the button will start to flash. Babytherm 8010 2 The following message appears in the text display: »Phototherapy: Use eye protection Press OK button to start XX:XX:XX«. 3 Press OK button = phototherapy lights switched on. 15 min 2 The following message appears in the text display for 5 seconds:...
  • Page 42: Switching Lighting On/off

    Operation Switching lighting On/Off 1 Press button. The bed surface will be illuminated by proce- dure light. Babytherm 8010 1 Press button again. The procedure light is switched off. 15 min 2 Press button. The bed surface will be illuminated by the night light.
  • Page 43: Configuration Mode

    Operation Configuration mode WARNING No care/therapy should be carried out during configura- tion of the system, because the normal equipment func- tions (e.g. temperature measurement, alarms) are switched off. Capabilities available in configuration mode Code Activity Show current software version Set skin temperature deviation Set volume of soft alarm Operating hours of phototherapy...
  • Page 44 Operation Show software version 1 The following message appears in the text display: »Configuration Mode Babytherm 8010 Mode c01: Software version«. 2 The current software version is indicated: e.g. »1.n«. 3 The code for the current mode is displayed: »c01« 15 min <...
  • Page 45 Operation Show operating hours for phototherapy 1 Briefly press button. 2 The following message appears in the text display: Babytherm 8010 »Configuration Mode Mode c04: Time counter photo therapy«. 3 Indication of the operating hours up to 1000 hours. 15 min 4 Press button for 3 seconds.
  • Page 46 Operation Test Nurse call 1 Briefly press button. 2 The following message appears in the text display: Babytherm 8010 »Configuration Mode Mode c06: Nurse Call Relay«. 3 The abbreviation for this mode appears: »Nuc«. 15 min 4 The code for the current mode appears: »c06«. 5 Display »0«...
  • Page 47 Operation Read error memory 1 Press button until error mode is active. Babytherm 8010 2 The following message appears in the text display: »Configuration Mode Error memory«. 15 min 3 The error number appears: »FXX«. < 36 C 4 Indication »Err«. skin C manual mattress .
  • Page 48: Oxygen Therapy

    Operation Oxygen therapy CAUTION Only enrich the oxygen concentration under the instructions of a doctor and only in accordance with the arterially measured oxygen partial pressure in the patient’s blood. Otherwise there is a danger of hyperoxaemia (which may damage a baby's eyes) or hypoxaemia (which may cause damage to the baby's brain).
  • Page 49: Taking X-rays

    Operation Taking X-rays Babytherm 8010, Babytherm 8004 without X-ray tray Swivel radiant warmer to one side. The infant will continue ● to be warmed. Place the X-ray film cartridge directly underneath the ● patient. Position the X-ray machine above the bed surface.
  • Page 50: Using Scale-tronix ® 4002-bt

    Operation ® Using Scale-Tronix 4002-BT WARNING Only use the integrated scale to determine the weight of the patient. Failure to follow the Instructions for Use can lead to severe inaccuracies in measuring the patient’s weight. To safeguard critical therapeutic decisions based on the patient’s weight, the weighing result should be checked against a reference measurement on an exter- nal scale.
  • Page 51: Weighing With Zero Calibration

    Operation Weighing with zero calibration Preparing for weighing Remove all objects that are simultaneously in contact with ● both the bed and the fixed environment or frame of Babytherm. Prepare the patient for lifting. ● Switch on the display unit of the scale Plug the power plug into a power supply socket.
  • Page 52: Weighing Without Zero Calibration

    Operation Weighing without zero calibration If the last zero calibration was performed no longer than 60 minutes earlier and no object has been removed from the bed or placed on it during this time, repeated calibration is not necessary. 1 Press » Reweigh«.
  • Page 53: Care

    Do not machine wash the mattress and do not autoclave it. The gel mattress may become permanently stained if it comes The Babytherm 8004/8010 infant warmer system must be into contact with liquid, alcoholic, iodine containing or iodine- thoroughly cleaned and disinfected like disinfectants.
  • Page 54: Before Next Use

    Care Before next use Do not expose device to UV radiation as a means of disinfecting/cleaning. Cracks may be caused in the acrylic Reassemble components, pages 9 onwards. ● glass components. After wipe-disinfecting, operate the fully assembled unit for ● Only use the recommended cleaning agents and disinfect- a few hours without a patient to eliminate any disinfectant ants.
  • Page 55: Troubleshooting

    Troubleshooting Troubleshooting General system failures Message Cause Remedy Red LED is lit, Power failure. Check that unit is plugged into mains. Audible alarm on. Check that the mains is switched on. Inform internal technical department. Call DrägerService. Red »Inop.« LED lit, Malfunction.
  • Page 56: System Faults - Radiant Warmer

    Troubleshooting System faults - radiant warmer Message Cause Remedy Yellow LED flashing, measured value The measured skin temperature If the measured value is higher than the set display flashing, message in text display: deviates from the set value by value: »Skin temp.
  • Page 57: System Faults - Scale-tronix

    Troubleshooting ® System faults - Scale-Tronix 4002-BT Fault Causes Remedy Display on screen: Device error. Call DrägerService. »E-FAIL« »r-FAIL« »n-FAIL« »Ad OuR« Display »O-LOAd« and continuous The scale is overloaded. Observe maximum load of 8 kg. beep Sensor cable not plugged in. Plug in sensor cable until it engages.
  • Page 58: Maintenance Intervals

    Maintenance Intervals Maintenance Intervals Always disinfect and clean the unit and accessories before any maintenance* – even when returning the unit to the supplier for repair. CAUTION Always disconnect power supply before any maintenance! Use only Dräger original parts for maintenance. Gel mattress Patch over small cuts or other damage in the covering film with adhesive tape.
  • Page 59: Disposing Of The Unit

    Maintenance Intervals Disposing of the unit At the end of its service life: Dispose of the unit in accordance with national waste ● disposal regulations, Ask a suitable disposal contractor to dispose of the unit. ● The local environmental agency can supply further details. For countries subject to EU Directive 2002/96/EC: This device is subject to EU Directive 2002/96/EC (WEEE).
  • Page 60: What's What

    10 Skin temperature sensor connector: 19 Swivel joint for radiant warmer, ±90° top socket, yellow – for measuring skin temperature 20 X-ray tray at rear – Babytherm 8004 only lower socket, white – for measuring peripheral skin 21 Bed canopy...
  • Page 61: Radiant Warmer

    What’s What Radiant warmer 1 Handle 2 Red central alarm lamp 3 Heater elements 4 Procedure light/night light 5 Phototherapy lights (optional), set of 6...
  • Page 62: Controller

    What’s What Controller Babytherm 8010 °C °C Check > 38 °C Inop. < 36 °C skin °C manual mattress °C skin man. 1 ON/OFF indicator: 8 Text display: provides advisory messages for the user and The green LED is lit when the unit is ON. prompts the user to confirm/acknowledge.
  • Page 63 What’s What Display and keypad for mattress heater Babytherm 8010 1 Display of measured (actual) mattress temperature 2 Indicator for upper extended range >38 °C 3 Indicator for lower extended range <36 °C °C 4 Keys (buttons) for setting the desired mattress temperature >...
  • Page 64: Controller, Rear View

    What’s What Controller, rear view 1 Inputs for connecting the Nurse call from up to three equip- ment units at the workstation (connections for central alarm) 2 Output for connection to internal paging systems, Nurse call (connection for central alarm) 3 RS 232 interface (BabyLink), optional 4 RS 232 interface (modem), optional 5 Controller ON/OFF switch;...
  • Page 65: Scale-tronix ® 4002-bt

    What’s What ® Scale-Tronix 4002-BT The scale in the Babytherm consists of a weighing unit located under the bed and a display unit. Scale display unit 1 Screen for displaying the weight 2 Measuring unit indicator for the weight display 3 Indicator for lifting the patient »...
  • Page 66: Technical Data

    Technical Data Technical Data Ambient conditions For operation Temperature 15 °C (59 °F) to 35 °C (95 °F) Atmospheric pressure 900 hPa to 1060 hPa rel. humidity 0 to 75 %, no condensation Air velocity in air-conditioned rooms max. 0.3 m/s For storage/transport Temperature –20 °C (–4 °F) to 60 °C (140 °F)
  • Page 67 Operating data Mains voltage 100 to 127 V / 220 to 230 V (to be specified on order) 50/60 Hz 240 V 50 Hz Current consumption (A) Babytherm 8004 Babytherm 8010 100 V 110 to 127 V 220 to 240 V...
  • Page 68 (Universal Medical Device Nomenclature System) Electromagnetic compatibility (EMC) according to EN 60601-1-2 Interface RS 232 Level measured according to DIN 66020 Monitor cable (Part No. 83 06 488) Babytherm 8004/8010 Monitor Wiring layout diagram 9-pin sub-D 9-pin sub-D socket socket Connector casing...
  • Page 69 Input Connection of the Nurse caller from up to 3 devices (the red central alarm LED lights up for every alarm forwarded from these devices to the Babytherm 8004/8010). Potential-free make contact Interfaces, optional All interface signals are electrically isolated from the patient sector.
  • Page 70 Technical Data Bed dimensions 750 x 490 mm (29.5 x 19.3 inches) Bed tilting adjustable in small increments Tilt maximum of 20° front end down maximum of 15° front end up Height of side panels 150 mm (5.9 inches) or 230 mm (9.1 inches) Height of inner walls 70 mm (2.8 inches)
  • Page 71: Scale-tronix ® 4002-bt

    Technical Data ® Scale-Tronix 4002-BT The measurement precision depends on the local geological and geographical conditions. The specified precision only applies if the device is calibrated at the installation site. Measuring range 250 g (0.6 lbs) to 8 kg (17.6 lbs) Measurement precision (e) 10 g (0.022 lbs) Resolution (d)
  • Page 72: Construction And Description

    Construction and Description Construction and Description Heated gel mattress The heated gel mattress consists of the following compo- nents: Babytherm consists of: gel mattress, aluminium heating plate and an electronic moni- – a chassis with infant bed and stand toring and control unit. –...
  • Page 73: Alarm Description

    Construction and Description Alarm description The Babytherm unit distinguishes three alarm levels: Warning (high potential risk) A continuous audible alarm that cannot be muted is emitted for: – device malfunction – power failure A sequence of alarms tones that can be muted, combined with a flashing red LED, is triggered for: –...
  • Page 74: Scale-tronix ® 4002-bt

    Construction and Description ® Scale-Tronix 4002-BT WARNING Only use the integrated scale to determine the weight of the patient. Failure to follow the Instructions for Use can lead to severe inaccuracies in measuring the patient’s weight. To safeguard critical therapeutic decisions based on the patient’s weight, the weighing result should be checked against a reference measurement on an exter- nal scale.
  • Page 75: Order List

    Shelf bracket mode, 100 V / 120 V / 230 V Centre distance: 37 mm G 13 822 Babytherm 8004 2M 30 404 Centre distance: 170 / 240 mm G 13 821 with baby control mode and...
  • Page 76: Parts List

    Order List Name and Description Part No. Name and Description Part No. Oxygen therapy with canopy Bacterial filter CH 102, set of 5 67 23 976 Injector for 230 mm side panels 2M 14 190 Secretion canister 2M 85 594 flowmeter, 0 to 16 L/min 2M 86 551 Bottle cap with valve, plastic...
  • Page 77: Index

    Index Index Activating the self-test ......19 Heat therapy Alarm Precautions ....... . 21 Baby control mode .
  • Page 78 Index Panels ........13 Warming bed .
  • Page 80 These Instructions for Use apply only to Babytherm 8004/8010 with Serial No.: If no Serial No. has been filled in by Dräger these Instructions for Use are provided for general information only and are not intended for use with any specific machine or device ç...

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Babytherm 8010

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