Dräger Babytherm 8004 Instructions For Use Manual
Hide thumbs
Also See for Babytherm 8004:
- Instructions for use manual (80 pages) ,
- Supplement manual (6 pages) ,
- Operating instructions manual (68 pages)
Related Manuals for Dräger Babytherm 8004
Summary of Contents for Dräger Babytherm 8004
- Page 1 Instructions for use Babytherm 8004/8010 Open intensive care, resuscitation WARNING To properly use this medical device, read and comply with these instructions for use.
-
Page 2: Typographical Conventions
The operating organization of this product must the task. ensure the following: The target group has read and understood the – The target group has the required qualifications chapters required to perform the task. (e.g., has undergone specialist training or Instructions for use Babytherm 8004/8010... -
Page 3: Safety Information Definitions
NOTE A NOTE provides additional information intended to avoid inconvenience during operation. Instructions for use Babytherm 8004/8010... -
Page 4: Abbreviations And Symbols
Abbreviations and symbols For explanations refer to the "Overview" chapter, "Abbreviations" and "Symbols" sections. Instructions for use Babytherm 8004/8010... -
Page 5: Table Of Contents
Contraindications ..... . . 15 Babytherm 8004 heating features ..16 Safety information . - Page 6 Order list ......123 Index ....... . 126 Instructions for use Babytherm 8004/8010...
- Page 7 Functional safety ..... . . 10 Product-specific safety information ..11 Instructions for use Babytherm 8004/8010...
-
Page 8: For Your Safety And That Of Your Patients
(MPBetreibV), see chapter labels. Failure to observe these safety "Service". information statements constitutes a use of the medical device that is inconsistent with its intended use. Applies only to the Federal Republic of Germany Instructions for use Babytherm 8004/8010... - Page 9 Device combinations (Dräger devices + Dräger devices or Dräger devices + third-party devices) approved by Dräger (see instructions for use of individual devices) meet the requirements of the following standards: Instructions for use Babytherm 8004/8010...
- Page 10 CAUTION Risk of patient injury Do not make therapeutic decisions based solely on individual measured values and monitoring pa- rameters. Instructions for use Babytherm 8004/8010...
-
Page 11: Product-Specific Safety Information
Do not operate the device in skin temperature mode with a temperature sensor connected and without a patient. Instructions for use Babytherm 8004/8010... - Page 12 Risk of incorrect medication The heating of transdermal medication (patches) can result in the administration of higher doses of active ingredient. When using transdermal medication, the patient must be monitored at close intervals. Instructions for use Babytherm 8004/8010...
- Page 13 – Do not obstruct the ventilation slots on the rear of the control unit. – Do not place objects that may impede cooling on the base plate above the voltage input module. Instructions for use Babytherm 8004/8010...
-
Page 14: Application
Contraindications..... . 15 Babytherm 8004 heating features ..16 Babytherm 8010 heating features ..16 Options . -
Page 15: Intended Use
Application Intended use Babytherm 8004/8010 is an open care unit for The unit may be used in operating theaters, warming premature babies, neonates and infants neonatal wards, children’s wards, obstetric units with a body weight of up to 8 kg. -
Page 16: Babytherm 8004 Heating Features
– Heated gel mattress, operating independently of the radiant warmer: the temperature of the heating pads is automatically monitored and adjusted to attain and maintain a preselected temperature at the contact surface between the infant and the mattress. Instructions for use Babytherm 8004/8010... -
Page 17: Options
MEDIBUS Software protocol for the transfer of data between Babytherm 8004/8010 and an external medical or non-medical device (e.g., patient monitors or computers for data management systems) via an RS 232 port, see "MEDIBUS for Dräger Pediatric Devices"... -
Page 18: Overview
Side view of the display unit ....24 Symbols ......25 Instructions for use Babytherm 8004/8010... - Page 19 5 Handle with inner release bar for tilting the bed 19 Swivel joint for radiant warmer, ±90° 6 Swivel cabinet, optional (left and/or right) 20 X-ray tray at rear – Babytherm 8004 only 7 Chassis with 4 castors, 2 of which are lockable 21 Bed canopy...
-
Page 20: Radiant Warmer
Overview Radiant warmer 1 Handle 2 Red central alarm lamp* 3 Heater elements 4 Procedure light/night light 5 Phototherapy lights (optional), set of 6 Country-specific function (e.g., not available in China) Instructions for use Babytherm 8004/8010... -
Page 21: Control Unit
7 Red alarm LED: flashes for Warning alarm (blue background). level. 14 On/Off button for radiant warmer; yellow LED in button is lit when radiant warmer is on. Instructions for use Babytherm 8004/8010... -
Page 22: Display And Control Panel For Mattress Heater, Babytherm 8010
6 Button for toggling between man. (manual mode) and Skin (skin temperature mode); the yellow LED lights up according to the selected mode. 7 Keys (buttons) for setting the desired skin temperature 8 Display for the skin temperature setting Instructions for use Babytherm 8004/8010... -
Page 23: Controller, Rear View
2 Output for connection to internal paging systems, Nurse call (connection for central alarm) 3 RS 232 interface (MEDIBUS), optional 4 RS 232 interface (modem), optional 5 Controller ON/OFF switch; = OFF, = ON. 6 Cover Instructions for use Babytherm 8004/8010... -
Page 24: Scale
7 kg button for displaying the weight in kilograms 8 Lb button for displaying the weigh in pounds* Start/Standby button for selecting standby or operating mode The verifiable scale can only display kg. Instructions for use Babytherm 8004/8010... -
Page 25: Symbols
Risk of crushing (foot) Note the conditions for tipping stability, see "Use of accessories" on page 27 Use light-proof eye cover Follow instructions for use Manufacturer Date of manufacture Revision index Part number Serial number Instructions for use Babytherm 8004/8010... -
Page 26: Preparation
Information about the nurse call..35 In-hospital transport....36 Instructions for use Babytherm 8004/8010... -
Page 27: Use Of Accessories
3 Standard rail on stand column Attach accessory loads as low and as close to the 4 Compact rail stand columns as possible and avoid one-sided loading 5 Standard rail, rear 6 Base plate 7 Swivel cabinet Instructions for use Babytherm 8004/8010... - Page 28 7 Nm (at an inclination and avoid one-sided of 10°). loading Standard rail on 2 kg stand column IEC 60601-1 tilt stability ensured up to an inclination of Standard rail, rear 5 kg 10° Instructions for use Babytherm 8004/8010...
-
Page 29: Shelf
3 Fasten the compact rail(s) to one column of the stand at the required height. 4 Fasten rail brackets and 1 Push X-ray tray fully home in the horizontal position. 5 small equipment bar to one column of the stand at the required height. Instructions for use Babytherm 8004/8010... -
Page 30: Warming Bed
With the panels on the long side, ensure that the handle points outwards. Position the panel semi-upright, 2 press the panel down firmly until the pins lock into position at the bottom of the slots. Instructions for use Babytherm 8004/8010... -
Page 31: Tilting The Bed
Maximum tilt angle: Head-up position: 20° Head-down position: 15° Preferred positions: Horizontal, 10° tilt head-up and 10° tilt head-down. The mattress may slip at maximum tilt. In this case do not place a sheet over the mattress. Instructions for use Babytherm 8004/8010... -
Page 32: Bronchial Aspirator
Fairfield rail Babytherm, 0.25 kg 2 kg short (0.55 lbs) (4.4 lbs) Fairfield rail Babytherm, 0.5 kg 5 kg long (1.1 lbs) (11 lbs) Small equipment pole 0.5 kg 13.5 kg (1.1 lbs) (29.8 lbs) Instructions for use Babytherm 8004/8010... -
Page 33: Accessories For O Therapy
Only attach oxygen cylinders and devices containing oxygen at the points intended for this purpose. WARNING Risk of patient injury due to operating noise Administering oxygen may cause additional background noise. Protect the patient from such background noise. Instructions for use Babytherm 8004/8010... -
Page 34: O 2 Flowmeter
Fitting the hose bracket Insert the hose bracket into the hole in the left side of the head panel and tighten with knurled screw. Prepare the O monitor in conformity with its specific Instructions for Use. Instructions for use Babytherm 8004/8010... -
Page 35: Storage
The nurse call will still be activated if the internal between the nurse call and the central hospital acoustic alarm generator of the medical device is alarm system. defective. Check the display on the screen of the medical device regularly. Instructions for use Babytherm 8004/8010... -
Page 36: In-Hospital Transport
If optional height adjustment is fitted, lower the unit to its lowest position. Swivel the swivel cabinets inwards. Swivel the swivel tray inwards. Remove X-ray cartridge from X-ray tray (see page 78). Instructions for use Babytherm 8004/8010... -
Page 37: Testing Readiness For Operation
Testing the lights......41 Testing phototherapy (optional) ... . 42 Instructions for use Babytherm 8004/8010... -
Page 38: Before Initial Operation
Do not use the connection as a PE connection. 3 Connect additional devices via an additional potential equalization connector with the second potential equalization pin. Instructions for use Babytherm 8004/8010... -
Page 39: Scale
Check that the required accessories and therapy equipment are available and in proper working order. Check that the gas supply is available and sufficient for the accessories to be used. Instructions for use Babytherm 8004/8010... -
Page 40: Checking Height Adjustment (Optional)
7 and the yellow LED is lit, the battery is being Press the On/Off button until it engages = ON. charged for the power failure alarm. It takes about 30 minutes to charge the battery. Babytherm now runs a self-test to check important functions. Instructions for use Babytherm 8004/8010... -
Page 41: Checking Leds, Displays And Audible Alarm
5 Press the button again. The night light will be the alarm sounds. switched off. A function check can also be carried out while the unit is in operation. Check at least once a day. Instructions for use Babytherm 8004/8010... -
Page 42: Testing Phototherapy (Optional)
8 The following message appears on the display: Photo therapy OFF Press OK button to confirm XX:XX:XX 7 Press OK button = phototherapy switched off. 6 The yellow LED in the button will go out. Instructions for use Babytherm 8004/8010... -
Page 43: Operation
Radiant warmer without mattress heater Babytherm 8004 ..... . . 61 Switching on ......47... -
Page 44: Precautions
Mattress heater Heat therapy/phototherapy WARNING CAUTION In the Babytherm 8004, use foam mattresses Risk of damage to the device (e.g. SoftBed) only, do not use gel mattresses. Do not bring any heat-sensitive objects or Risk of hypothermia. - Page 45 Risk of fire! Do not use electrical devices under the bed Do not place medication or infusion solutions canopy. Devices that are approved for in the heated area. operation in potentially explosive areas are excluded. Instructions for use Babytherm 8004/8010...
- Page 46 The patient's core temperature functions (e.g., temperature measurement, alarms) should be monitored in order to prevent adverse are switched off. effects on the temperature balance. Instructions for use Babytherm 8004/8010...
-
Page 47: Switching On
Display of new selected heater output level. providing warmth by placing your hand carefully at Yellow LED in the button is lit continuously: a safe distance from the radiant warmer. man. mode is now active. Instructions for use Babytherm 8004/8010... -
Page 48: 15 Minutes Alarm
If there is no acknowledgement after 15 minutes the heating will switch off. – The audible alarm remains on. 1 The yellow LED starts flashing and – the red central alarm lamp on the radiant warmer starts flashing. Instructions for use Babytherm 8004/8010... -
Page 49: Using Baby Control Mode
Secure the sensor cable with adhesive tape (plaster). Regularly check that the skin temperature sensor is in the correct position. Measure the patient’s core temperature regularly using a separate thermometer! Instructions for use Babytherm 8004/8010... - Page 50 Press the OK button = confirm setting. The new set value is displayed. The yellow Skin LED lights up, indicating that Skin temperature control mode is active. 6 The measured skin temperature value is displayed. Instructions for use Babytherm 8004/8010...
-
Page 51: Outside Measuring Range
Immediately connect the sensor plug or change the skin temperature sensor. The audible alarm 3 dashes at the bottom of the display = can be muted for 15 minutes: temperature below 15 °C 4 Press the button Instructions for use Babytherm 8004/8010... -
Page 52: Skin Temperature Above 39 °C
Skin temp. deviation above 0.5 °C Press OK button to acknowledge The permitted skin temperature deviation can be 1 The skin temperature display flashes. set in configuration mode, see page 70. – The audible alarm sounds. Instructions for use Babytherm 8004/8010... -
Page 53: Thermomonitoring
1 Plug the white sensor fully into the white socket. 2 Route the sensor cable through one of the flexible grommets in the bed. 3 Remove the protective film from the adhesive pad and place the skin temperature sensor on the pad. Instructions for use Babytherm 8004/8010... -
Page 54: Data Output Via Interface, Optional
The following message appears on the display: EN 60601-1 and EN 60601-1-2. Radiant heater turned OFF Following the associated Instructions for Use. Press button again = radiant warmer can be switched on again, see page 47. Instructions for use Babytherm 8004/8010... -
Page 55: Using Heated Gel Mattress
8 Press the OK button = confirm new setting. 10 seconds, the message will disappear and the 6 The new set value is displayed. previous setting will remain in effect. 9 The yellow 38 °C indicator is lit continuously. Instructions for use Babytherm 8004/8010... -
Page 56: Extending The Lower Limit Of The Setting, Range From 36 °C To 30 °C
Set mattress temperature Press OK button to confirm Babytherm 8010 4 Press the OK button = confirm new setting. 2 The new set value is displayed. 5 The yellow <36 °C indicator is lit continuously. Instructions for use Babytherm 8004/8010... -
Page 57: Mattress Temperature Above 40 °C
– the audible alarm is suppressed during the display: warm-up phase: Mattress temp. above 40°C 1 The yellow LED is lit. The alarm stops automatically as soon as the mattress heater temperature drops below 39 °C. Instructions for use Babytherm 8004/8010... -
Page 58: Using 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. Instructions for use Babytherm 8004/8010... -
Page 59: Recommended Heater Settings For Heat
Cool the patient: Set the mattress temperature to a value lower than the current core temperature, e.g. to 36 °C. Instructions for use Babytherm 8004/8010... -
Page 60: Using Radiant Warmer Only
Manually swivel the radiant warmer to the right or left. Check the patient's temperature at regular intervals. Do not cover or dress the patient. Otherwise, the effect of the radiant warmer is uncontrollably reduced. Instructions for use Babytherm 8004/8010... -
Page 61: Radiant Warmer Without Mattress Heater Babytherm 8004
For a very hypothermic patient: Set the mattress temperature and the skin temperature setpoint so that an increase in the patient temperature of approximately 1 °C per hour is achieved. Instructions for use Babytherm 8004/8010... - Page 62 Set mattress temperature to the desired core To stabilize or maintain patient temperature: temperature. If necessary, set skin control Set the mattress temperature and skin temperature to a slightly lower value. temperature to the current core and skin temperature, respectively. Instructions for use Babytherm 8004/8010...
-
Page 63: Using Phototherapy (Optional)
Direct eye contact with the radiation source for an extended period when in use should be avoided. CAUTION Protect patients in the immediate vicinity of the phototherapy device from the radiation emitted, e.g. by using goggles and shields. Instructions for use Babytherm 8004/8010... -
Page 64: Switching On
1 Press button for 3 seconds. 2 The following message appears in the text display: Photo therapy durationXX:XX:XX Press OK to reset the counter 3 Press OK button = counter reset. 2 The display now reads: Photo therapy duration00:00:00. Instructions for use Babytherm 8004/8010... -
Page 65: Switching Lighting On/Off
1 Press the button again. The working light will be switched off. 2 Press the button. The bed will be lit by the night light. 2 Press the button again. The night light will be switched off. Instructions for use Babytherm 8004/8010... -
Page 66: Alarms
Muting the acoustic alarm signal of active alarms....... . 69 Instructions for use Babytherm 8004/8010... -
Page 67: Safety Information
If the cause of an alarm has been resolved, the alarm will be removed from the list. Acoustic alarm signals It is always the unacknowledged alarm with the highest priority that is acoustically signaled. For information on muting, see chapter "Acknowledging and suppressing alarms". Instructions for use Babytherm 8004/8010... -
Page 68: Central Alarm
Prompt action is (unacknowledged necessary in order to Medium-priority alarm), alarm LED Caution avert a danger. alarm is lit (acknowledged alarm) Note Low-priority Attention and action alarm are necessary. Country-specific function (e.g., not available in China) Instructions for use Babytherm 8004/8010... -
Page 69: Acknowledging And Suppressing Alarms
Babytherm 8004/8010 reacts as follows: If a new alarm occurs during the suppression time – The alarm message is displayed. of an active alarm, Babytherm 8004/8010 reacts as follows: – The acoustic alarm signal is suppressed. – The acoustic alarm signal sounds. -
Page 70: Configuration Mode
X-ray tray ......78 Babytherm 8004 with X-ray tray ... . 78 Using the scale . -
Page 71: Safety Information
Show current software version working with the radiant warmer! Set skin temperature deviation Set volume of soft alarm Operating hours of phototherapy Test control panel buttons Test Nurse call Set language Set display contrast Error mode Instructions for use Babytherm 8004/8010... -
Page 72: Mode
Configuration mode is now active. The 8 Change states for the activated mode equipment is in mode c01 and shows the 9 Show setting in current mode current software version. Show software version Babytherm 8010 Instructions for use Babytherm 8004/8010... -
Page 73: Set Permissible Skin Temperature Deviation
Factory setting: 0.5 °C. 6 Press the button until the required value appears on the display. Values can be set from 0.3 to 1.0 °C in increments of 0.1. Instructions for use Babytherm 8004/8010... -
Page 74: Show Operating Hours For Phototherapy
15 min < 36 C skin C manual mattress . C skin man . 1 Briefly press the button. 2 The following message appears on the display: Configuration Mode Mode c05 : Keyboard test (inactive). Instructions for use Babytherm 8004/8010... -
Page 75: Test Nurse Call
7 Press the button for 4 seconds. The relay Check Possible settings: 1 to 11. is activated. The Inop alarm is triggered: the red Inop. LED lights up and a continuous alarm tone sounds. Instructions for use Babytherm 8004/8010... -
Page 76: Set Display Contrast
7 Press the button. The equipment runs a 255 in increments of 1. Check self-test. 8 Press button for 3 seconds. The error memory is erased. Return to radiant warmer mode Press the OK button. Instructions for use Babytherm 8004/8010... -
Page 77: O 2 Therapy
Set O supply on flowmeter. Injector setting Vol.% O supply L/min 10 Monitor the O concentration. After use Open the bed canopy. Close the valve on the O flowmeter = turn clockwise. Instructions for use Babytherm 8004/8010... -
Page 78: Taking X-Rays
Configuration mode Taking X-rays Babytherm 8010, Babytherm 8004 Babytherm 8004 with X-ray tray without X-ray tray The X-ray tray has no lock and can be completely removed from the Babytherm. Swivel radiant warmer to one side. The infant will continue to be warmed. -
Page 79: Using The Scale
Use only scales authorised for use with Ba- in the measured weight. However, since these bytherm. The serial numbers of the weighing deviations are systematic, they do not affect trend unit and display unit must match. observations. Instructions for use Babytherm 8004/8010... -
Page 80: Weighing With Zero Calibration
Babytherm. – 2 beeps are emitted. 0.00 is displayed on the screen. When the Lower Patient indicator lights up: Lay the patient on the bed. The weighing operation is performed. Instructions for use Babytherm 8004/8010... -
Page 81: Shutting Down
Configuration mode Shutting down Press the On/Off button. The green "On" LED will go out. Instructions for use Babytherm 8004/8010... -
Page 82: Reprocessing
Special reprocessing measures ... . 87 Before next use ..... . . 88 Instructions for use Babytherm 8004/8010... -
Page 83: Dismantling
The Babytherm 8004/8010 infant warmer system Clean and disinfect all accessories, e.g. bronchial must be thoroughly cleaned and disinfected aspirator, in accordance with their specific –... -
Page 84: Classifications For Reprocessing
Semi-critical (A, B) Components that carry breathing gas or come into contact with mucous membranes or pathologically altered skin Critical (A, B, C) Components that penetrate skin or mucous mem- branes or come into contact with blood Instructions for use Babytherm 8004/8010... -
Page 85: Reprocessing List
– Phototherapy filter glass Non-critical Semi-critical – Bed frame, inside and outside – Gel mattress (Babytherm 8010) – Side panels, inside and outside – SoftBed foam mattress (Babytherm 8004) – Inside walls, inside and outside Reprocessing list Components Surface disinfection Special reprocessing... -
Page 86: Reprocessing Procedures
Bleach Cleaner Dispatch Hospital Cleaner Disin- fectant Towels with Bleach Klorsept 17 Medentech Oxygen-releasing agents Descogen Liquid Antiseptica Descogen Liquid r.f.u. Dismozon plus Bode Chemie Dismozon pur Oxycide Ecolab USA Perform Schülke & Mayr Virkon DuPont Instructions for use Babytherm 8004/8010... -
Page 87: Surface Disinfection With Cleaning
5 Check the product for visible soiling. Repeat the mattress can still be used. steps 1 to 5 if necessary. SoftBed foam mattress (Babytherm 8004): 6 Check the product for visible damage and replace if necessary. Clean and wipe disinfect as required and after every change of patient. -
Page 88: Before Next Use
3 in man. mode. Before a patient is next placed in the unit: Fit all therapy accessories required. Check that the unit is ready for operation, see Page 37 and following pages. Instructions for use Babytherm 8004/8010... -
Page 89: Message - Cause - Remedy
System faults - radiant warmer ... 92 System faults - scale ....94 Instructions for use Babytherm 8004/8010... -
Page 90: General Device Errors
If used in combination Measured value dis- above 40 °C. with radiant warmer: play flashing, message Reduce the output lev- in text display: Mat- el of the radiant warm- tress temp. above 40°C, audible alarm sounds. Instructions for use Babytherm 8004/8010... - Page 91 45 °C. Three dashes at bot- Mattress temperature Wait until mattress tom of measured value <5 °C. temperature is above display. Message on 5 °C. display: Mattress temp. below 5°C Instructions for use Babytherm 8004/8010...
-
Page 92: System Faults - Radiant Warmer
Switch to man. mode; three middle segments replace sensor and of the measured value then switch back to display are flashing, Skin mode. message in text dis- play: Skin temp. sen- sor fault, audible alarm sounds. Instructions for use Babytherm 8004/8010... - Page 93 14 min Red LED flashes, the Sensor defective. Replace sensor. three middle segments of the measured value display are flashing, the message Periph- eral temp. sensor fault appears on the display and the audible alarm sounds. Instructions for use Babytherm 8004/8010...
-
Page 94: System Faults - Scale
Babytherm must not be ex- posed to any vibrations. Check the connection and position of the sensor cable. In the event of any unexpected behaviour of the device, call DrägerService. Instructions for use Babytherm 8004/8010... -
Page 95: Service
Repairs ......99 Calibration (Weighing scale option) ..100 Instructions for use Babytherm 8004/8010... -
Page 96: Safety Information
Measures intended to determine and assess the actual state of a medical device Maintenance Recurrent specified measures intended to maintain the functional condition of a medical device Repair Measures intended to restore the functional condition of a medical device after a device malfunction Instructions for use Babytherm 8004/8010... -
Page 97: Inspection
Performing the inspection – Check the condition of the two heating elements. Check for signs of thermal overload. To perform the inspection of Babytherm 8004/8010, 4 Check equipment of medical device for use the specifications for the safety checks. completeness according to the instructions for use. -
Page 98: Maintenance
Only perform service activities when there is no patient in the device. CAUTION Risk of electric shock Do not set up or store the device in a dirty environment. Check the device at regular intervals for dust residues. Instructions for use Babytherm 8004/8010... -
Page 99: Repairs
In case of fault Replace as soon as the User material becomes brittle and/or sticky. Repairs Dräger recommends that all repairs are carried out by DrägerService and that only authentic Dräger repair parts are used. Instructions for use Babytherm 8004/8010... -
Page 100: Calibration (Weighing Scale Option)
Specialized service scale personnel 1) E.g., after repair of the weighing scale or essential components. 2) Check the measuring accuracy of the measuring scale at regular intervals, commission new adjustment and official calibration as necessary. Instructions for use Babytherm 8004/8010... -
Page 101: Disposal
To initiate collection or for further information, visit Dräger on the Internet at www.draeger.com. Use the Search function with the keyword "WEEE" to find the relevant information. If access to Dräger's website is not possible, contact the local Dräger Organization. Instructions for use Babytherm 8004/8010... -
Page 102: Technical Data
....... 117 Instructions for use Babytherm 8004/8010... -
Page 103: Ambient Conditions
5000 hours Lights 120 V / 230 V Working light max. 16 W Night light max. 16 W Minimum clearance between top edge of radiant >50 cm warmer and ceiling 1) measured as per IEC 60601-2-21 Instructions for use Babytherm 8004/8010... -
Page 104: Skin Temperature Measurement
Alarms Low-priority alarm Medium-priority High-priority Mains power dB(A) alarm dB(A) alarm dB(A) supply failure alarm / device error dB(A) Measured in front of >65, factory the device at a dis- setting tance of 3 m Instructions for use Babytherm 8004/8010... -
Page 105: Phototherapy (Optional)
400 x 200 mm The intensity of the bilirubin-affecting irradiation power decreases as the number of operating hours of the bulb increases. 1000 Time [min] Irradiated useful area on the bed (mm) Instructions for use Babytherm 8004/8010... -
Page 106: Operating Data
120 V 120 V without height adjust- ment without phototherapy without height adjust- ---- ---- 10.3 ment with phototherapy with height adjustment 10.3 11.4 without phototherapy with height adjustment ---- 13.9 ---- 15.0 with phototherapy Instructions for use Babytherm 8004/8010... -
Page 107: Standards
Heating surface of mattress Type BF Classification (according to EC Directive 93/42/EC Appendix IX) Class IIb UMDNS Code 15-610 (Universal Medical Device Nomenclature System/ nomenclature for medical devices) Electromagnetic compatibility (EMC) according to EN 60601-1-2 Instructions for use Babytherm 8004/8010... - Page 108 Coding resistance Pin 2 Pin 3 Pin 4 Open Pin 5 SHLD-GND Pin 6 Open Pin 7 Modem: Internally connected MEDIBUS: open Pin 8 Modem: Internally connected MEDIBUS: open Pin 9 Coding resistance Housing SHLD-GND Instructions for use Babytherm 8004/8010...
- Page 109 Connection for external modem for service pur- poses Wiring layout diagram Central alarm Output for connecting internal paging systems (Nurse call) Operating voltage max. 24 V Current max. 250 mA Power max. 3 W Potential-free changeover contact Instructions for use Babytherm 8004/8010...
-
Page 110: Dimensions
150 mm (5.9 inches) or 230 mm (9.1 inches) Height of inner walls 70 mm (2.8 inches) Size of the X-ray cartridge Width 500 mm Depth 480 mm Height 18 mm with X-ray tray 23 mm without X-ray tray Instructions for use Babytherm 8004/8010... -
Page 111: Weight (With One Cabinet)
Stand column < 5.0 kg (attach accessory loads as low and as close to the stand columns as possible and avoid one-sided loading) Maximum tilting moment < 25 Nm Individual wheel load < 100 kg Instructions for use Babytherm 8004/8010... -
Page 112: Scale
(geographical latitude and altitude) must therefore be considered, if necessary, by means of an on-site calibration prior to commissioning if the initial calibration information does not correspond to the re- spective gravitational zone or no gravitational zone has been designated. Instructions for use Babytherm 8004/8010... -
Page 113: Emc Declaration
Dräger. If adjacent or stacked use of configurations not approved by Dräger is inevitable, verify correct functioning of the medical device in this configuration before it is used. In any case, strictly observe the instructions for use of the other devices. Instructions for use Babytherm 8004/8010... -
Page 114: Electromagnetic Emissions
(without transformer) to the public low-voltage power supply network that supplies buildings used for domestic pur- poses. Harmonic emissions Not applicable (IEC 61000-3-2) Transmission of voltage fluctua- Not applicable tions and flicker (IEC 61000-3-3) Instructions for use Babytherm 8004/8010... -
Page 115: Electromagnetic Immunity
Dip >95%, 5 seconds >95%, 5 seconds vice requires continued operation during mains power supply interrup- tions, it is recommended that the medical device be powered from an un- interruptible power sup- ply or a battery. Instructions for use Babytherm 8004/8010... - Page 116 150 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 Babytherm 8004/8010...
-
Page 117: Recommended Separation Distances From Portable And Mobile High-Frequency Communication Equipment
GSM 1800, GSM 1900 (limited to 1 W ERP) 1.83 m (6 ft) UMTS, DECT (limited to 0.25 W ERP) 0.91 m (3 ft) Bluetooth, WLAN 2450, RFID 2450 (limited to 0.1 W ERP) 0.58 m (1.9 ft) Instructions for use Babytherm 8004/8010... -
Page 118: Construction And Description
Alarm description..... . 121 Scale ....... . 122 Instructions for use Babytherm 8004/8010... - Page 119 The set temperature is only attained in the areas where the patient is in contact with the mattress. System monitoring includes self-check routines and alarms. Instructions for use Babytherm 8004/8010...
- Page 120 If the current Skin temp. below Radiant heater is skin temperature deviates by more than ±0.5 °C* range switched off. from the target value, an alarm sounds which can be suppressed by the user. Instructions for use Babytherm 8004/8010...
-
Page 121: Alarm Description
The text display shows a specific message for the active alarm. If a second alarm is triggered while the audible alarm is muted, the audible alarm will be reactivated. Instructions for use Babytherm 8004/8010... -
Page 122: Scale
The entire weighing process is accompanied by brief acoustic signals (beeps), so that the nurse’s full attention can be devoted to the patient. Instructions for use Babytherm 8004/8010... -
Page 123: Order List
Vacuum controller VarioVac D MP 00 511 Inner panel 2M 20 936 rail Swivel cabinet 2M 20 638 Ejector VarioAir D rail MP 00 542 Cabinet fixing 2M 20 868 Clamp for 38 mm tube 2M 85 274 Instructions for use Babytherm 8004/8010... - Page 124 MP 01 444 Hug-It positioning aid, size M MP 01 416 MX 300-i, T-adapter (22 mm) MP 01 445 Nest positioning aid MP 01 417 Positioning aid set (4 small pil- MP 01 418 External ventilation lows) Instructions for use Babytherm 8004/8010...
- Page 125 2M 30 462 pink Medela APGAR timer 2M 30 466 Stand for the phototherapy de- 2M 21 190 vice SoundEar G 24 925 SoundEar power supply unit G 24 926 Service documentation on re- quest Instructions for use Babytherm 8004/8010...
-
Page 126: Index
Validated ......86 In-hospital transport ..... . 36 Instructions for use Babytherm 8004/8010... - Page 127 Radiant warmer ..... . 92 X-rays Using ......78 Instructions for use Babytherm 8004/8010...
- Page 128 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 medical product or device.
Need help?
Do you have a question about the Babytherm 8004 and is the answer not in the manual?
Questions and answers