Dräger 8000 IC Operating Instructions Manual
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Dräger 8000 IC Operating Instructions Manual

Dräger 8000 IC Operating Instructions Manual

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Incubator 8000 IC
with ThermoMonitoring
Operating Instructions

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  • Page 1 Incubator 8000 IC with ThermoMonitoring 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 Content Page Page Checking Readiness for Operation Introduction READ THIS FIRST Before each Use Operator's Responsibility for Patient Safety Checking Height Adjustment Limitation of Liability Checking Hand Ports Warranty Checking Front Door Definitions Checking Air Filter General WARNINGS and CAUTIONS Testing Bed Tilt Mechanism Precautions During Preparation Activating Incubator Self Test...

  • Page 4: Introduction Read This First

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

  • Page 5: Warranty

    Warranty Introduction Warranty Application of this warranty is subject to the following All Dräger products are guaranteed to be free of de- conditions: fects for a period of one year from date of delivery. 1. Dräger, Inc. or its authorized representative must The following are exceptions to this warranty: be promptly notified, in writing, upon detection of 1.

  • Page 6: Definitions

    Introduction 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. Inspection = examination of measured condition Service...

  • Page 7: General Warnings And Cautions

    This device is neither approved nor certified for use in areas where combustible or Maintenance or repair of the Incubator 8000 IC explosive gas mixtures are likely. shall be performed only by Dräger authorized technical service representatives.

  • Page 8: Precautions During Preparation

    Introduction Precautions During Preparation Precautions During Operation Precautions During Preparation Precautions During Operation Readiness for Operation WARNING ! Never leave baby unattended when front door or hand ports are open to avoid any risk of a WARNING ! patient falling out of the incubator. The incubator is ready for operation only when all checks have been performed successfully.
  • Page 9 Precautions During Operation Introduction Skin Temperature Control Fire hazards associated with the use of oxygen WARNING ! WARNING ! Skin temperature control must not be used Fire Hazard! with babies in shock. Because of reduced Keep matches, lighted cigarettes, and all peripheral bloodflow the skin temperature of other sources of ignition out of the room in these babies occasionally lies below the core...

  • Page 10: Precautions During Care

    Preventive Maintenance work on the Incubator always immediately recognized. Do not sterilize 8000 IC may be performed by trained and incubator and its components with ethylene oxide factory authorized staff only.
  • Page 11 Introduction This page intentionally left blank...

  • Page 12: Intended Use

    Only accessories listed in this Operator's Manual are recommended by Dräger for use with the Incubator 8000 IC. The safety of combinations of this device with other equipment is the sole responsibility of the user and must be determined on the basis of the individual situation.

  • Page 13: Description

    Principle of Operation Description Description Principle of Operation Heated and humidified air flows into the hood over the full width of the incubator. It is channeled up the front door, along the roof of the hood, and then drawn down along the rear wall via suction.

  • Page 14: Alarm Hierarchy

    Description Alarm Hierarchy Ergonomics Hygiene Alarm Hierarchy The incubator features a hierarchical system of alarms. Any faults occurring generate an alarm signal that is com- municated according to its priority. If a non-essential function fails, the functions which are of vital importance remain in operation.
  • Page 15 This page intentionally left blank...

  • Page 16: What's What

    What's What Front View Rear View What's What Front View Hood Sensor module Front door latch Front door Hand port Hand port latch Control panel with quick reference on flap Tube through bearings °C FEUCHTE/HUMID. °C LUFT/AIR °C HAUT/SKIN/PEAU/PIEL °C LUFT/AIR Control Bed with mattress and endboard Mounting rail, left and right...

  • Page 17: Control Panel

    Control Panel What's What Main Module Control Panel °C HAUT/SKIN/PEAU/PIEL °C LUFT/AIR Alarm % FEUCHTE/HUMID. VOL.%O Control Control Control Inop. Control Vol.% Cal. °C °C >37 °C >40% °C °C Vol.%O >37 °C >40% ±1.5 °C ± 5 Vol.% ± 1.0 °C Check Check Reset...

  • Page 18: Air Temperature Control Module

    What's What Air Temperature Control Module Air Temperature Control Module Key to switch on air temperature control (only with skin temperature control option). °C LUFT/AIR Unlocking key, extends range for set Control temperatures °C >37 °C Yellow LED >37 °C, °C >37 °C is lit when a higher range of values has been set.

  • Page 19: Skin Temperature Control Module

    Skin Temperature Control What's What Module Skin Temperature Control Module On/off button for skin temperature control. Calibration sign, not applicable in the US. Button to display the peripherical skin temperature. °C HAUT/SKIN/PEAU/PIEL Green LED Control; is lit when skin temperature Control module is switched on.

  • Page 20: Oxygen Control

    What's What Oxygen Control Module Oxygen Control Module 4.1 On/off button for the oxygen control. 4.2 Unlocking key, extends the range of oxygen set concentration up to 75 % FiO 4.3 Yellow LED >40 % FiO VOL.%O Control is iluminated when set range was extended. Vol.% Cal.

  • Page 21: Humidity Control Module

    Humidity Control Module What's What Humidity Control Module On/off button for humidity control. Green LED Control; is iluminated when humidity control is on. % FEUCHTE/HUMID. Display of the current measured value of relative Control humidity in %. Display of the humidity set value; left arrow down: decrease the set value right arrow up: increase the set value.

  • Page 22: Labels

    What's What Labels Labels WARNING ! DANGER OF PATIENT INJURY NEVER LEAVE BABY UATTENDED WHEN FRONT DOOR OR HAND PORTS ARE OPEN DANGER ! RISK OF EXPLOSION IF USED IN THE PRESENCE OF FLAMMABLE °C FEUCHTE/HUMID. °C LUFT/AIR °C HAUT/SKIN/PEAU/PIEL °C LUFT/AIR ANESTHETICS Control...

  • Page 23: Preparation

    Before First Time Use Preparation Front Flap Quick Reference Flap Preparation Note: The incubator is delivered fully assembled. Before First Time Use Check that all packaging material has been removed. Front Flap To open the front flap 1 Squeeze catches with thumb and index finger and open the front door.

  • Page 24: Hood

    Preparation Hood Open up Double Walls Mattress Hood To open the hood Tilt the hood back as far as it will go. Note: Do not let the hood fall back to the normal position on the incubator base by itself. This may damage the incubator and the hood.

  • Page 25: Trendellenburg Position

    Trendellenburg Position Preparation Port Hole Doors Repositioning Bed Endboard Trendellenburg Position Turn left hand wheel to raise the left side of the mattress for Trendelenburg position. Turn right hand wheel to raise the right side of the mattress for reverse Trendelenburg position. Adjust the mattress to the desired position.

  • Page 26: Adjust Working Height

    Preparation Adjust Working Height Open Rear Panel Adjust Working Height connect with mains power 1 push down right foot pedal – incubator will drive up 2 push down left foot pedal – incubator will drive down WARNING ! This device is to be used only in rooms with line power installations complying with nation- al safety standards for hospital patient rooms.

  • Page 27: Connect Sensor Module

    Connecting Sensor Module Preparation Connecting Sensor Module The sensor module contains the sensors for air temperature humidity and oxygen concentration (two sensors). swing module outwards and lift it up to mount the O sensors, unscrew the retaining cap. Install O sensor and put retaining cap back in place.

  • Page 28: Mounting Accessories

    Ventilator circuit support arm Mounting Accessories Instrument tray Mounting plate Mounting Accessories Ventilator circuit support arm • Fold down front door. Raise bed and lift out of incubator. Push mattress slightly to one side. Push hose support into appropriate hole, right or left. Screw on knurled screws from below and tighten.

  • Page 29: Iv Pole

    Attaching equipment Mounting Accessories IV pole Attaching equipment to mounting plate Example: Babylog 8000 Remove plastic foot strips from ventilator. Tilt Babylog forward by about 45°. 1 Insert front latches into slots in mounting plate. 2 Lower Babylog, insert rear latches into slots in mounting plate, and secure at the back with knurled screws.

  • Page 30: Additional Swivel Cabinet

    Note: When using electrical equipment, such as puls oximeters or Laptop Computers with the Incubator 8000 IC always verfy that the devices fulfill the leakage current requirements. If neccessary use an medical isolation transformer to linit the leakage current.

  • Page 31: Routing Cables And Hoses

    Routing Cables and Hoses Preparation Routing Cables and Hoses Route hoses, cables, or lines through the access grommets provided. Note: Port hole doors with additional access grommets are available upon request for both left and right door flaps. Attach ventilator circuits and cables to clips on end of support arm.

  • Page 32: Oxygen Therapy

    Attach hose to connector nipple on O flowmeter and 2 to O port at the right underneath incubator body. NOTE: The Incubator 8000 IC features an unrestricted oxygen input port. In order to restrict flow to limit oxygen concentrations, use external oxygen limiter.
  • Page 33 Preparation Preparing for Oxygen Therapy If an oxygen limiter is used: Connect oxygen limiter between O flowmeter and incubator port. WARNING ! Oxygen Concentration It is absolutely essential that elevated oxygen concentrations are selected on the basis of arterially measured oxygen partial pressure in the blood of the baby.

  • Page 34: Checking Readiness For Operation

    Before each use Checking Readiness for Operation Checking height adjustment Checking Readiness for Operation Before using incubator for the first time Verify that line voltage corresponds to the specification on the rating plate. Check under section Technical Data for supply voltage range. Before each use Verify that equipment has been disinfected.

  • Page 35: Checking Hand Ports

    Checking hand ports, front Checking Readiness for door and air filter Operation Testing bed tilt mechanism Checking hand ports for proper closure 1 Grip rim of closed hand port and pull outwards – it should not open. In case hand port does not remain engaged: Call DrägerService.

  • Page 36: Activating Incubator Self Test

    Checking Readiness for Activating incubator self-test Operation Checking power failure alarm Activating incubator self-test Swivel down flap with short description. °C FEUCHTE/HUMID. °C LUFT/AIR °C HAUT/SKIN/PEAU/PIEL °C LUFT/AIR Control 1 Push power switch down – until it engages = ON. Incubator performs self-test.

  • Page 37: Checking Leds, Displays And Alarm

    Checking LEDs, displays and Checking Readiness for alarm sound Operation Checking LEDs, displays and alarm sound 1 Press k button: For about 2 seconds – all LEDs are lit (except the power failure LED), the digital displays show 88.8 and an audible alarm is generated.

  • Page 38: Operation

    Operation General Precautions During Patient Care Operation General Precautions During Patient Care Warm-up time Allow adequate time for the incubator to warm up before placing a baby inside (about 35 minutes). Recommendation: operate incubator in standby. Note: Warm-up time depends on the ambient temperature. Incubator temperature control system –...
  • Page 39 Operation General Precautions During Patient Care Reducing incubator temperature The time it takes for the incubator to cool off is a design feature, it can be shortened when necessary by: – reducing the outside (room) temperature (where possible), – reducing the incubator setting for humidity. –...
  • Page 40 Operation General Precautions During Patient Care Physiological risks associated with the use of oxygen WARNING ! Oxygen Concentration The atmosphere inside the incubator should only be enriched with oxygen by or on the order of a physician or respiratory therapist. It is absolutely essential that elevated oxygen concentrations are selected on the basis of arterially measured oxygen partial pressure in...
  • Page 41 General Precautions During Operation Patient Care WARNING ! Do not cover phototherapy lights or incubator hood with blankets, aluminum foil, or other materials intended to boost the effect of phototherapy. This would cause build-up of heat since the incubator would not be cooled by ambient air, a factor absolutely essential for operation.

  • Page 42: Starting Operation

    2 Remove empty water bottles from receptacle and replace with three full bottles. Lift rear panel and close it. – If your incubator 8000 IC is equiped with the automatic water feed system change the attached water bag. NOTE: If an automatic water feed system is used,...

  • Page 43: Using Air Temperature Control

    Using Air Temperature Control Operation Using Air Temperature Control WARNING ! Always measure baby's core temperature at regular intervals! 1 Push power switch in – until it engages = ON. 2 Green LED is lit. Wait for self-test to complete. Incubator will then switch to "air temperature control"...
  • Page 44 Operation Extending Temperature Range Extending Temperature Range From 37 °C to 39 °C WARNING ! Temperatures above 37 °C may only be used on the order of a physician. In this mode of operation, the baby´s temperature must be monitored especially carefully.
  • Page 45 Alarms Operation Central Alarm Alarms Central Alarm 1 Red LED Alarm flashes and audible alarm will occure. °C LUFT/AIR The intermittent audible alarm can be silenced for 10 minutes: 2 Press G key, °C >37 °C 3 yellow LED will be lit. Reset Check Control...

  • Page 46: Using Skin Temperature Control

    Operation Alarms, Air Control Using Skin Temperature Control Connecting skin temperature sensor To switch back to "air temperature control" with the module "skin temperature control" installed and in operation: 1 Press ç key, °C LUFT/AIR 2 green LED Control is lit. "air temperature control"...
  • Page 47 Using Skin Temperature Control Operation WARNING ! Always verify that single use sensor probe is specified and approved for use with Dräger Series 8000 incubators. Attach sensor tip to skin at an appropriate measuring point using a skin probe adhesive cover pad (if not part of the sensor itself).
  • Page 48 Operation Using Skin Temperature Control Activating skin temperature control NOTE: When a skin temperature sensor is connected while "air temperature control" mode is active, the measured skin temperature is still displayed. However, it does not affect the incubator °C HAUT/SKIN/PEAU/PIEL °C LUFT/AIR temperature, which is controled only by the set air temperature.
  • Page 49 Using Skin Temperature Control Operation The incubator offers different default values, depending on the situation. Status Default 36.3 °C Set value for air temperature not confirmed; defective or disconnected sensor Measured skin temperature was below 35 °C 35 °C when switched to skin mode Measured skin temperature was bet- measured skin ween 35 °C and 37 °C when switched temperature...
  • Page 50 Operation Using Skin Temperature Control Always allow enough time to reach steady state skin temperature air temperature Differences between set and measured value of skin temperature are responsible for controlling air set value temperature inside the incubator between a minimum of actual value 28 °C and a maximum of 39 °C.
  • Page 51 Alarms Operation Alarms In case of deviations greater or equal than ±1.0 °C between set and measured value of skin temperature: 1 Red LED Alarm and 2 Red LED ±1.0 °C flashing, °C HAUT/SKIN/PEAU/PIEL °C LUFT/AIR 3 display flashing accompanied by intermittent audible °C °C alarm.

  • Page 52: Thermo Monitoring, Optional

    Operation Thermo Monitoring Display Peripherical Skin Temperature Thermo Monitoring with ThermoView Necessary for Thermo Monitoring: – Second receptacle for peripherial skin temperature sensor, white plug! – Optional BabyLink interface board with ThermoView Software and BabyLink Interface cable – Personal computer, see specifications in ThermoView Operators Manual, or –...

  • Page 53: Using Humidity Control

    Using Humidity Control Operation Using Humidity Control Air temperature and relative humidity are interdependent. Automatic Humidity Regulation Automatische Feuchteregelung If the setting of the incubator air temperature changes, the incubator adjusts humidifier output to keep relative humidity inside the incubator constant despite the changed conditions.
  • Page 54 Operation Using Humidity Control Water Supply Alarm Switch from manual mode to automatic mode: 1 Press ç button = Humidity module is switched off, 2 green LED Control goes out. % FEUCHTE/HUMID. 1 Press ç button again = Humidity module is switched on in automatic mode.

  • Page 55: Using Oxygen

    Using Oxygen Operation Calibration of Oxygen Sensor Using Oxygen WARNING ! It is absolutely essential that elevated oxygen concentrations are selected on the basis of WARNING ! arterially measured oxygen partial pressure in Oxygen Concentration the blood of the baby. This is the only way of The atmosphere inside the incubator should minimizing the risk of both hyperoxemia, only be enriched with oxygen by or on the...
  • Page 56 Operation Setting oxygen concentration higher that 40 % O Alarms After about 45 to 135 seconds calibration is complete. 1 Display shows alternately CAL and 21 Vol.% O Swing sensor module back to its operating position VOL.%O inside the hood, otherwise sensor alarm. Vol.% 2 The set value »21«...
  • Page 57 Using Oxygen Operation Alarms Switch off O -Control In the case of a pulled sensor module plug, a swung out sensor module, or a defect sensor: 1 Red LED alarm will light and 2 red alarm-LED sensor will light, intermittend audible alarm starts.
  • Page 58 Operation Using Oxygen without oxygen control module Using oxygen without the oxygen control module Monitor O concentration. Always use calibrated analyzer according to its Operating Instructions. Supply oxygen from a medical gas pipeline system or oxygen tank via an O flowmeter.
  • Page 59 Notes Operation...

  • Page 60: Care Disassembly

    Care Disassembly Emptying water reservoir Care Clean and disinfect incubator after each patient, or at least once a week. Perform all disinfection procedures according to established hospital procedures as well as to the following additional instructions. WARNING ! Always follow established hospital procedures for handling equipment contaminated with bodily fluids.
  • Page 61 Disassembly Care If skin temperature control option has been used: Disconnect skin temperature sensor. Open front door. Remove skin temperature sensor from inside incubator. Remove all silicone U-grommets. Tilt incubator hood back as far as it will go. Do not use force or push the hood further back.

  • Page 62: Cleaning/Disinfecting/Sterilizing

    Care Cleaning / Disinfecting / Sterilizing Cleaning / Disinfecting / Sterilizing CAUTION ! Certain components of the incubator consist of materials that are sensitive to certain organic solvents sometimes used for cleaning and disifecting (e.g., alcohols, phenols, halogen releasing compounds, oxygen releasing compounds, strong organic acids, etc.).

  • Page 63: Reassembly

    Cleaning / Disinfecting / Sterilizing Care Reassembly – Fan, – seals, – U-grommets, – water hose, – water bottle holder, or water feed system container. Wash with detergent and rinse with clean water or autoclave. Bath disinfect parts. Allow exposure time for disinfection as prescribed, then rinse with clear water and dry;...

  • Page 64: Care For Humidification System

    Care Reassembly Care for Humidity System Before Reusing Incubator Installing hand port seals: Insert seal marked with an "L" on its molded tag into left opening Insert seal marked with an "R"on its molded tag into right opening Position molded tag of seal directly on top of hinge. Install with sealing lip (thin edge of profile) facing outside.
  • Page 65 Notes Care...

  • Page 66: Troubleshooting

    Troubleshooting Master Switch Module Troubleshooting Master Switch Module Alarm Inop. Check Problem/Message Likely Causes Remedy Red LED Inop lit. General defect in electronics. Switch incubator off and on again. Continuous audible alarm. If Inop message is not repeated: press ƒ key and reset values. If Inop message comes up again, incubator is out of order .

  • Page 67: Air Temperature Control Module

    Air Temperature Control Troubleshooting Modul Air Temperature Control Module °C LUFT/AIR Control °C >37 °C °C >37 °C ±1,5 °C Reset Control Sensor Problem/Message Likely Causes Remedy LED ±1.5 °C flashing. Air temperature in incubator is Temperature below set value: Display of measured value flashing.

  • Page 68: Skin Temperature Control Module

    Troubleshooting Skin Temperature Control Module Skin Temperature Control Module °C HAUT/SKIN/PEAU/PIEL Control °C °C ± 0,5 °C Check 15.22 Control 36 °C 87.06 ±0,1 Sensor Problem/Message Likely Causes Remedy Red LED ±1.0 °C flashing. Skin temperature deviating from Below set value: Display of measured value flashing.

  • Page 69: Oxygen Control

    Oxygen Control Module Troubleshooting Oxygen Control Module VOL.%O Control Vol.% Cal. >40% Vol.%O >40% ± 5 Vol.% Cal. Control Sensor Problem/Message Likely Causes Remedy Red LED ±5 Vol.% flashes. Oxygen concentration deviates from Below set value: Close openings on set value by more that ±5 %. Measured value flashes.

  • Page 70: Humidity Control Module

    Troubleshooting Humidity Control Module Humidity Control Module % FEUCHTE/HUMID. Control Control Sensor Problem/Message Likely Causes Remedy Red LED H O flashing. Water supply depleted. Refill water container. Display of set value flashing. Intermittent audible alarm. Err display flashing alternately with Defective humidifier while Switch off humidifier.

  • Page 71: Height Adjustment

    Height Adjustment Troubleshooting Height Adjustment Problem/Message Likely Causes Remedy When pushing on the pedals the Thermo protector engaged. Let the motor cool down for incubator does not go up or down. one hour. Incubator has reached end position. Maximum or minimum position reached.

  • Page 72: Inspection And Maintenance

    Inspection and Replacement of Parts Maintenance Inspection and Maintenance WARNING ! To avoid any risk of infection, clean and disin- fect incubator and accessories before any maintenance according to established hospital procedures - this applies also when returning units or parts for repair. WARNING ! Always disconnect supply before servicing.

  • Page 73: Preventive Maintenance Intervalls

    Incubator 8000 IC. For information on Biomed training to become certified on the Dräger Incubator 8000 IC call your closest Dräger...
  • Page 74 Preventive Maintenance Notes...

  • Page 75: Technical Data

    Technical Data Technical Data Ambient conditions: During operation 20 °C to 30 °C Temperature Atmospheric pressure 900 to 1100 hPa Rel. humidity 15 to 95 % During storage 0 °C to 70 °C Temperature Atmospheric pressure 900 to 1100 hPa Rel.
  • Page 76 EN 60601-1, IEC 601-1 and IEC 601-2-19, CSA 22.2-125 Type B Manufacturer's certification of The 8000 IC Incubator is certified to be free of radio electromagnetic compatiblity interference emissions pursuant guideline EN 55014:1987/A2 1990, and it complies with guideline 89/336/EEC regarding immunity from electromagnetic interference.

  • Page 77: Ordering Information

    Ordering Information Name and description Order No. Name and description Order No. Basic unit Spare parts Incubator 8000 IC, USA 2M 21 973 Air filter 84 02 926 with control of air temperature, humidity, Mattress 2M 20 907 skin temperature control...
  • Page 80 This Operating Instruction Manual applies only to Incubator 8000 IC with serial no.: Without entry of a serial-no. by Dräger, these Operating Instruc- tions provide general information only and are not intended for use with a specific device! Dräger Medizintechnik GmbH Germany Moislinger Allee 53 –...

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