Dräger Babytherm 8004 Operating Instructions Manual
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Dräger Babytherm 8004 Operating Instructions Manual

Infant warmer system
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Babytherm
8004/8010
Infant Warmer System
Operating Instructions

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  • Page 1 ® Babytherm 8004/8010 Infant Warmer System Operating Instructions...
  • Page 2 NOTICE Proprietary Information This document contains information in which Dräger, Inc. claimed proprietary rights. The information may not be reproduced in whole or in part except as authorized in writing by Dräger. This information is the property of Dräger, Inc., it is provided solely for the use intended.

  • Page 3: Table Of Contents

    Contents Contents Page Page Important Safety Information READ THIS FIRST. 4 Inspection and Maintenance....... 52 Operator's Responsibility for Patient Safety.... 4 Replacement of Parts..........52 Limitation of Liability..........4 Preventive Maintenance Intervals......52 Warranty..............5 Troubleshooting..........53 Definitions.............. 6 General..............53 General WARNINGS and CAUTIONS....

  • Page 4: Important Safety Information Read This First

    Important Safety Information Operator's Responsibility for Patient Safety Limitation of Liability Operator's Responsibility for Patient Safety Limitation of Liability For correct and effective use of the product and in Dräger, Inc.'s liability, whether arising out of or related order to avoid hazards it is mandatory to carefully to manufacture and sale of the goods, their installation, read and to observe all portions of this manual.

  • Page 5: Warranty

    Important Safety Information Warranty Warranty All Dräger products are guaranteed to be free of Application of this warranty is subject to the following defects for a period of one year from date of delivery. conditions: The following are exceptions to this warranty: 1.

  • Page 6: Definitions

    Important Safety Information Definitions Definitions WARNING ! A WARNING statement refers to conditions with a possibility of personal injury if disregarded. CAUTION ! A CAUTION statement designates the possibility of damage to equipment if disregarded. NOTE: A NOTE provides additional information intended to avoid inconveniences during operation.

  • Page 7: General Warnings And Cautions

    Important Safety Information General WARNINGS and CAUTIONS General WARNINGS and CAUTIONS WARNING ! WARNING ! Strictly follow this Operator's Instruction Skin temperature control must not be used Manual with babies in shock. Because of reduced peripheral blood flow the skin temperature of Any use of the product requires full these babies occasionally lies well below the understanding and strict observation of all...

  • Page 8: Precautions During Preparation

    Important Safety Information Precautions During Preparation Precautions During Operation Precautions During Preparation Precautions During Operation WARNING ! WARNING ! Always select correct mattress type for Never leave patient unattended when intended mode of operation (see page 20). surrounding panels are down. Risk of patient injury by infant falling out of the bassinet.
  • Page 9 Important Safety Information Precautions During Operation WARNING ! WARNING ! Mattress Heater Skin temperature control must not be used (Babytherm 8010 only) with babies in thermic shock. Because of reduced peripheral blood flow the skin When mattress heating is used, the gel mat- temperature of these babies occasionally lies tress must be placed directly on the heated well below the core body temperature.
  • Page 10 Important Safety Information Precautions During Operation WARNING ! WARNING ! Physiological risks of oxygen ! Use temperature settings in the lower exten- ded temperature range only on the order of a – Oxygen therapy only on the order of a physician.

  • Page 11: Precautions During Care

    (EtO) is also authorized service personnel. not recommended. CAUTION ! Do not expose Babytherm 8004/8010 to high levels of ultraviolet radiation. This may cause cracks in the PMMA (acrylic glass) parts. CAUTION ! Do not launder mattresses in an automatic washing machine.

  • Page 12: Intended Use

    Intended Use Intended Use Babytherm 8004 warms with a radiant heater providing Babytherm 8004/8010 is an infant warmer system both "manual control" and "skin temperature control" intended as a therapeutic device providing warmth for modes. premature and full-term neonates and infants with a Babytherm 8010 warms with a radiant heater providing weight up to16 lbs.
  • Page 13 Operating Concept Overview Overview Babytherm 8010 Babytherm 8010 °C °C Babytherm 8004 Check >38°C <36°C Inop. Skin °C Mattress °C manual Babytherm 8004 Skin man. °C Check Inop. Skin °C manual Skin man.

  • Page 14: Theory Of Operation

    Description of System Components Mattress heating Babytherm consists of The Babytherm 8004/8010 features a mattress heating – a mobile chassis with the attached infant bed system that uses conductive heat transfer to warm up – a controller unit with operating panel patients and to keep them warm.The system consists...
  • Page 15 They therefore provide for good skin color representation. Phototherapy is switched on the main controller panel. Modes of heater operation Babytherm 8004 – Operation of radiant heater with preset heater output: Heater output is controlled in "manual" mode and therapy is time-limited for higher heater output settings.

  • Page 16: Alarm System

    Theory of Operation Alarm System Alarm System The Babytherm controller distinguishes three levels of alarms. High potential for patient risk a continuous audible alarm (enunciator) that cannot be silenced, for: – device malfunction, – power failure an alarm tone sequence (loudspeaker) that can be silenced in combination with flashing red LED, for: –...

  • Page 17: Operating Concept

    Theory of Operation Operating Concept Operating Concept Babytherm 8010 °C °C Check > 38°C Inop. < 36°C Skin °C Mattress °C manual Skin man. Status LEDs Display and keypad for radiant heater: Green LED continuously on during operation. top: display for measured values of skin temperatures Red LED continuously on during power outages.

  • Page 18: Preparation

    Preparation Preparing Column Accessories Preparation Preparing Column Accessories Monitor shelf Babytherm comes equipped with one monitor shelf. Mounting rail elements (available option) to monitor shelf: Attach rail element to left and/or right of monitor shelf with screws provided. CAUTION ! Always verify that monitor shelves and other accessories are securely attached.

  • Page 19: Preparing The Bed

    Preparation Preparing the Bed Preparing the Bed The bed is surrounded by two side panels and two end panels, which can be opened independently of each other. End panels have cutouts with U-grommets for routing circuits and patient cables. Installing surrounding panels 1 Insert lower pins on panel hinges into the left- and right-hand slots in bassinet base.
  • Page 20 Select mattress type: – Operation with mattress heating (Babytherm 8010 only): Gel mattress 2M 20 827. – Operation without mattress heating (Babytherm 8004): Foam rubber mattress 2M 21 012. WARNING ! Always select correct mattress type for intended mode of operation.

  • Page 21: Attaching Ventilator Circuit Support Arm

    Preparation Attaching Ventilator Circuit Support Arm Supplies Storage Options Adjusting the Height (Option) Attaching Ventilator Circuit Support Arm Insert flexible support arm into hole in the left side of head panel and tighten with knurled screw. Supplies Storage Options Units with height adjustable column: –...

  • Page 22: Preparing For Intra-Hospital Patient Transport

    Turn off heating systems and disconnect unit from power. For intra-hospital transport of a patient with Babytherm 8004/8010: Install cover (available accessory) to protect patients from cold drafts: 1 Position cover on the end panels. Side panels can still be opened when cover is installed, end panels cannot be opened.

  • Page 23: Testing Readiness For Operation

    Testing Readiness for Operation Before First Use Before Each Use Testing Readiness for Operation Before First Use Verify that supplied voltage matches values indicated on the rating plate next to the power cables. WARNING ! To maintain grounding integrity, connect only to a "hospital grade"...
  • Page 24 Testing Readiness for Operation Before Each Use Switching on and activating self test Press On/Off button, until it engages = ON. Running a self test, Babytherm will now check important functions. 1 The green »Power On«-LED is lit. 2 After approximately 2 seconds, Babytherm displays Babytherm 8010 the radiant heater mode: »man.«...
  • Page 25 Testing Readiness for Operation Before Each Use Testing power failure alarm Babytherm 8010 Disconnect power plug. 1 Red LED will light simultaneously with continuous audible alarm. 15 min °C Reconnect power. Babytherm will continue to operate with values set < 36°C skin °C before power failure.

  • Page 26: Operation

    Operation Precautions During Patient Care Operation Precautions During Patient Care Mattress heater WARNING ! WARNING ! Never leave patient unattended when Mattress Heater surrounding panels are down. Risk of patient (Babytherm 8010 only) injury by infant falling out of the bassinet. When mattress heating is used, the gel mat- tress must be placed directly on the heated tray surface.
  • Page 27 Operation Precautions During Patient Care Radiant heater Oxygen therapy (with optional accessories) WARNING ! WARNING ! Skin temperature control must not be used Fire Hazards from oxygen ! with babies in thermic shock. Because of – No open flames or cigarettes ! reduced peripheral blood flow the skin Textiles, plastics, and oils readily ignite in temperature of these babies occasionally lies...

  • Page 28: Using The Radiant Heater

    Operation Using the Radiant Heater Setting Heater Output Manually Using the Radiant Heater After switching Babytherm on, it will suggest a mode of operation for the radiant heater: Babytherm 8010 – no skin temperature probe connected = »man.« (manual mode) 15 min °C –...
  • Page 29 Operation Setting Heater Output Manually 1 Press »OK« key = confirm heater output at suggested level. Babytherm 8010 2 press p or P key to select heater output level. 15 min °C 1 Press »OK« key = confirm heater output. NOTE: If »OK«...

  • Page 30: Using Skin Temperature Control

    Operation Using Skin Temperature Control Using Skin Temperature Control In this mode of operation, the infant's skin temperature is controlled towards a set value using a temperature probe attached to the skin. When the measured value for skin temperature is lower than the set value, the radiant heater operates at a high output level.
  • Page 31 (order separately, see "Ordering Information", page 65). WARNING ! Always verify that sensor probe is specified and approved for use with Dräger Babytherm 8004/8010. 1 Plug yellow sensor connector into yellow jack. 2 Route sensor cable through one of the flexible grommets onto bed surface.
  • Page 32 Operation Using Skin Temperature Control WARNING ! When using skin temperature control mode, check infant skin condition at regular intervals and verify that skin temperature probe is securely attached. A detached probe will measure air temperature and the baby might become overheated.
  • Page 33 Operation Using Skin Temperature Control Exceeding the measuring range If temperature is outside the measuring range (15 °C to 42 °C): °C 3 dashes at the bottom of display = temperature below 15 ºC, 3 dashes at the top of display = temperature above 42 ºC.
  • Page 34 Operation Using Skin Temperature Control Deviations greater than ±0.5 °C between set and measured value for skin temperature: Babytherm 8010 1 Display of skin temperature starts blinking. 2 Yellow LED starts blinking. 15 min °C Additionally, flashing red central alarm light on the radiant heater.

  • Page 35: Thermomonitoring

    Operation ThermoMonitoring ThermoMonitoring™ For improved feedback on thermal condition of a patient, we recommend measuring both central and peripheral skin temperatures (tummy-toe measurement). Attaching peripheral skin temperature sensor 1 Plug white sensor connector into white jack. 2 Route sensor cable through one of the flexible grommets onto bed surface.

  • Page 36: Switching Radiant Heater Off

    Operation Switching Radiant Heater Off Switching Radiant Heater Off 1 Press key. Babytherm 8010 2 Display shows message: Radiant heater OFF Press OK-button to confirm. 15 min °C 3 Press »OK« key. Radiant heater is turned off. 1 Press key again = radiant heater can be turned on <...

  • Page 37: Using Mattress Heater (Babytherm 8010)

    Operation Using Mattress Heater (Babytherm 8010) Using Mattress Heater (Babytherm 8010) WARNING ! Always warm up mattress before placing patient. Do not switch off Babytherm while a baby is lying on the gel mattress as this will result in uncontrolled cooling of patient. Allow approximately 1 hour for thorough warm-up.
  • Page 38 Operation Using Mattress Heater (Babytherm 8010) Extending lower limit of setting range: WARNING ! Use temperature settings in the lower exten- ded temperature range only on the order of a physician. Watch patient particularly carefully! 1 Press p key, until Babytherm 8010 2 set value 36.0 ºC is displayed.
  • Page 39 Operation Using Mattress Heater (Babytherm 8010) Deviation from set temperature In case of deviations greater than ±1 °C between set Babytherm 8010 and measured mattress temperature values: 1 Yellow LED starts blinking. 15 min °C 2 Measured value of mattress temperature starts blinking.

  • Page 40: Notes On Heater Settings

    Operation Notes on Heater Settings Notes on Heater Settings Notes on settings for use of the mattress heater with and without radiant heater. Using radiant and mattress heater with a gel mattress (Babyherm 8010) Normal settings: The patient's core temperature will, in the long run, adjust to the mattress temperature.
  • Page 41 Operation Notes on Heater Settings Mattress heater with gel mattress operated without radiant heater (Babytherm 8010) Normal settings: The patient's core temperature will, in the long run, adjust to the mattress temperature. Therefore, set mattress heater to a core temperature appropriate for the particular patient, e.g.
  • Page 42 Operation Notes on Heater Settings Using radiant heater only (Babytherm 8004) WARNING ! Check the baby´s core temperature at regular intervals and adjust temperature setting to individual patient needs. Do not use bassinet covers. Otherwise, the radiant heater will not have the intended effect. The acrylic hood is not transparent for infared radiation from the radiant heater.

  • Page 43: Using Phototherapy (Available Option)

    Operation Using Phototherapy (Availble Option) Using Phototherapy (Available Option) WARNING ! Always use patient eye protection when using phototherapy. WARNING ! Always consider differentiated diagnosis for patient so life sustaining measures are not delayed. WARNING ! Check the baby´s core temperature at regular intervals.

  • Page 44: Configuration Mode

    Operation Configuration Mode Configuration Mode Possible Activities Code Activity Displaying current software version Selecting skin temperature alarm threshold Adjusting speaker volume for alarms Hours of operation, phototherapy Testing control panel keys Testing nurse call Selecting language Adjusting display contrast Error reporting NOTE: The control panel keys and displays have a Babytherm 8010 different purpose/meaning than in radiant heater...
  • Page 45 Operation Configuration Mode Selecting skin temperature alarm threshold 1 Press P key briefly. Babytherm 8010 2 Display message: Configuration mode 15 min °C Mode c02: Max. skin temperature fault. 3 Abbreviation for this activity is displayed: SdE. < 36°C skin °C 4 The current activity code is displayed: c02.
  • Page 46 Operation Configuration Mode Tasting control panel keys 1 Press P key briefly. Babytherm 8010 2 Display message: Configuration mode Mode c05: Keyboardtest (inactive). 15 min °C 3 Abbreviation for this activity is displayed: but. < 36°C 4 The current activity code is displayed: c05. skin °C manual mattress.°C...
  • Page 47 Operation Configuration Mode Selecting language 1 Press P key briefly. Babytherm 8010 2 Display message: Configuration mode 15 min °C Mode c07: Display language –> English. 3 Abbreviation for this activity is displayed: LAN. < 36°C skin °C 4 The current activity code is displayed: c07. manual mattress.°C skin...

  • Page 48: Switching Lighting On/Off

    Operation Switching Lighting On/Off Central Alarm Switching Lighting On/Off 1 Press key, bed surface is now illuminated by work light. Babytherm 8010 1 Press key again, work light is switched off. 15 min °C 2 Press key, bed surface is now illuminated by night light.

  • Page 49: Taking X-Rays

    Operation Taking X-Rays Shutting Down Taking X-Rays Babytherm 8004 Pull x-ray tray out from under mattress. Place x-ray cassette in the appropriate location on the tray. Place infant in center of mattress. Swivel radiant heater sideways. Heater will continue warming patient.

  • Page 50: Care

    Disassembly Cleaning / Disinfecting / Sterilizing Care Cleaning / Disinfecting / Sterilizing The Babytherm 8004/8010 infant warmer system must be thoroughly cleaned and disinfected after each patient, or at least once a week. Perform any disinfection CAUTION ! procedures according to established hospital procedures Certain components of the bassinet consist of as well as to the following additional instructions.

  • Page 51: Cleaning/Disinfecting/Sterilizing

    Radiant heater in "manual" mode set to heater level 3. Remove visible impurities with a disposable cloth wetted in a detergent. Before a patient is placed in the Babytherm 8004/8010: Wipe-disinfect surfaces. Set up accessories for therapy as needed. Wipe and dry with a clean, damp cloth.

  • Page 52: Inspection And Maintenance

    Phototherapy lamps Replace complete set (6 bulbs) WARNING ! if defective or after Maintenance work on the Babytherm 8004/8010 1000 hours of operation may be performed by trained and factory by factory trained technician. authorized staff only.

  • Page 53: Troubleshooting

    Troubleshooting General Mattress Heater General Problem/Message Likely Causes Remedy N N N N No power Check that Babytherm is plugged in. Red LED lit, Check that power is not interrupted continuous audible alarm. Call building maintenance. Call DrägerService. Red LED »Inop.« lit, Device malfunction Call DrägerService.
  • Page 54 Troubleshooting Radiant Heater Radiant Heater Problem/Message Likely Causes Remedy Yellow LED flashing, Measured value of skin temperature When measured value is below set Measured value display blinking, has deviated from set value by more value: Check that skin temperature than ± 0.5 ºC. message: probe is positioned correctly.

  • Page 55: What's What

    Chassis with casters, 2 of which can be locked Support columns with monitor shelf and two side rail Height adjustable column (available option) X-Ray tray on the back side, Babytherm 8004 only Foot controls, for height adjustable column (9) (without illustration) Height adjustment warning label...

  • Page 56: Radiant Heater

    What's What Radiant Heater Radiant Heater Handle Central alarm light, flashes if an alarms needs to be acknowledged Ceramic heater elements Lighting (work light, night light) Phototherapy lights (6)

  • Page 57: Controller

    What's What Controller – Babytherm 8004/8010 Controller Babytherm 8010 °C °C Check > 38°C Inop. < 36°C Skin °C Mattress °C manual Skin man. 1 Operation indicators: 8 Text display, shows messages and prompts user to Green LED lit for operation..
  • Page 58 What's What Controller – Babytherm 8004/8010 Display and keypad for radiant heater 11.1 11.2 11.3 11.4 11.1 Display of measured value for "tummy" skin temperature 11.2 Foot symbol for peripheral ("toe") temperature; is lit when peripheral skin temperature sensor is °C...

  • Page 59: Controller - Rear View

    What's What Controller – Rear View Controller – Rear View Input ports for connecting nurse call of up to three devices in the work place (connections for central alarm). Output port for connecting to paging, nurse call systems (connection for central alarm). RS 232 interface (modem), available option RS 232 interface (BabyLink), available option Controller power switch...

  • Page 60: Labels

    What's What Labels Labels Main WARNING/CAUTION label WARNING ! DANGER ! DO NOT SWITCH OFF BABYTHERM WHILE A BABY IS LYING ON THE RISK OF EXPLOSION IF USED IN THE PRESENCE OF FLAMMABLE ANES- GEL MATTRESS AS THIS WILL RESULT IN COOLING OF THE PATIENT THETICS WARNING ! WARNING !

  • Page 61: Technical Data

    Technical Data Technical Data Ambient conditions For operation: 20 °C to 30 °C (68 °F to 104 °F) Temperature Atmospheric pressure 900 hPa to 1060 hPa Relative humidity 0 to 75 %, no condensation Air velocity in climate rooms max. 0.3 m/s For storage and transport: –20 °C to 60 °C (–4 °F to 140 °F) Temperature...
  • Page 62 Technical Data Phototherapy (available option) Lamps Halogen 12 V / 50 W (6 needed) Lighting angle 24º Irradiance at 80 cm distance from light 9.5 W/m source and for useable area of 400 x 200 mm Area on mattress with specified intensity Relative intensity light spectrum Relative spectral intensity Wavelength...
  • Page 63 All interface signals are electrically isolated from any components in contact with patient. Isolation test voltage is 1.5 kV. ™ BabyLink interface RS 232 Babytherm 8004/8010 Monitor Output voltage pursuant RS-232-C Monitor cable (part no. 83 06 488) Wiring scheme 9 pin Sub D...
  • Page 64 Technical Data Central alarm Output for connection to paging systems (nurse call) Operation voltage max. 24 V Current max. 250 mA Power max. 3 W Electrically isolated relais contact Input Connection of nurse call output of up to 3 devices. (For each alarm forwarded by any of these devices to Babytherm 804/8010, the red central alarm light will light.) Electrically isolated relais contact...

  • Page 65: Ordering Information

    Ordering Information Name and Description Part No. Name and Description Part No. ® Babytherm 8010, 120 V FR 00 120 Accessories with mattress heater and Cover 2M 21 030 skin temperature control Cover prop 2M 21 342 ® Babytherm 8004, 120 V FR 00 114 Infusion bottle holder 2M 16 520...

  • Page 66: Index

    Index larms eripheral sensor, connecting........35 mattress heater..........38 - 39 Power failure alarm, checking........25 skin temperature control....... 32 - 33 Precautions radiant heater............29 during preparation..........8 Alarm system.............16 during operation............ 8 Ambient conditions............ 61 during care............11 during maintenance..........11 efore next use............51 Preparing accessories.........18, 21 Preparation............
  • Page 68 These Instructions for Use apply only to Babytherm 8004 or Babytherm 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.

This manual is also suitable for:

Babytherm 8010

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