Dräger Medical Air-Shields Isolette C400 QT User manual

WARNING:
For a full understanding of the performance
characteristics of this equipment, the user
should carefully read this manual before
operating.
Models C400 QT® and
C450 QT®
Operating Instructions
Air-Shields® Isolette®
Infant Incubators
xxxxxxxx

iv

PROPRIETARY AND CONFIDENTIAL DRAFT 19 Nov 04
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Table of Contents
Section 1: Symbol Definition and Intended Use
Symbol Definition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 1
Technical Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 4
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 4
Section 2: Introduction, Features, and Specifications
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 1
Functional Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 2
Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 3
Standard Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 3
Temperature Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 3
Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 4
Continuously Variable Mattress Tilt Mechanism. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 6
Quiet Latch Access Doors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 6
Optional Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 6
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 7
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 7
Standard Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 8
Optional Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 10
Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 10
Regulation, Standards, and Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 11
Device Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 11
Electromagnetic Compatibility (EMC) Guidance and Manufacturer’s Declaration . . . . 2 - 11
Section 3: Precautions and Safety Tips
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 1
Electrical Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 1
Explosion Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 1
Oxygen Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 2
Electromagnetic Compatibility Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 3
Safety Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 4
Swivel Monitor Shelves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 7
Warning Labels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 8
Section 4: Installation and Assembly
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 1
Unpacking. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 1
Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 2
Incubators Equipped with the Standard Cabinet Stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 2

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Incubators Equipped with a Variable Height Adjustable (VHA) Stand. . . . . . . . . . . . . . . . . . 4 - 3
Warm Weigh® Infant Scale, Model I20 (Accessory) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 4
General Operation and Functional Checkout Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 5
Section 5: Instructions for Use
Instructions for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 1
Air Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 3
To Select: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 3
Auxiliary Air Probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 3
Baby Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 4
Oxygen Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 5
Humidity Reservoir. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 7
Controls, Indicators, and Connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 8
Optional Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 14
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 16
Cabinets and Drawers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 17
Swivel Shelves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 17
Section 6: Cleaning, Maintenance, Replacement Parts, and Storage and Handling
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 1
General Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 1
Cleaning Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 1
Steam Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 2
Cleaning Difficult to Access Areas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 2
Cleaning Painted Surfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 2
Cleaning Clear Plastic and Acrylic Surfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 2
Disinfecting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 2
Disassembly for Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 2
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 5
Cleaning the Skin Probe (Model C450 QT® Isolette® Infant Incubator Only). . . . . . . . . 6 - 5
Cleaning the Humidity Chamber and Fill Pipe, Air Intake Tube, Access Door Gaskets,
and Tubing Access Gaskets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 6
Cleaning the Controller. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 6
Cleaning the Mattress Tray and Deck Plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 7
Cleaning the Mattress Tilt Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 7
Cleaning the Hood and Cabinet Stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 7
Cleaning the Air Intake Microfilter Chamber. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 7
Assembly After Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 8
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 11
Power Failure Alarm Battery Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 11

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Replacement Parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 12
Storage and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 13
Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 13
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 13
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 13
Section 7: Troubleshooting
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 - 1

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NOTES:

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Section 1
Symbol Definition
and Intended Use
Symbol Definition
This manual contains different typefaces and icons designed to improve readability and increase
understanding of its content. Note the following examples:
• Standard text—used for regular information.
•Boldface text—emphasizes a word or phrase.
•NOTE:—sets apart special information or important instruction clarification.
• The symbol below highlights a WARNING or CAUTION:
Warning and Caution
– A WARNING identifies situations or actions that may affect patient or user safety. Disregarding a
warning could result in patient or user injury.
– A CAUTION points out special procedures or precautions that personnel must follow to avoid
equipment damage.
• The symbol below highlights a CAUGHT HAZARD WARNING:
Caught Hazard Warning
• The symbol below highlights a CHEMICAL HAZARD WARNING:
Chemical Hazard Warning
• The symbol below highlights an ELECTRICAL SHOCK HAZARD WARNING:
Electrical Shock Hazard Warning

PROPRIETARY AND CONFIDENTIAL DRAFT 19 Nov 04
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This product contains different icons designed to increase understanding. Note the following examples:
• The symbol below indicates “Attention: Consult accompanying documents:”
Attention: Consult Accompanying Documents
• The symbol below indicates “Type B equipment with an F-type floating applied part:”
Type B Equipment with an F-Type Floating Applied Part
• The symbol below indicates “AC power:”
AC Power
• The symbol below indicates “Protective earth (ground):”
Protective Earth (Ground)
• The symbol below indicates “Air Mode Control indicator:”
Air Mode Control Indicator
• The symbol below indicates “Air Mode Control selection key:”
Air Mode Control Selection Key
• The symbol below indicates “Baby Mode Control indicator:”
Baby Mode Control Indicator
• The symbol below indicates “Baby Mode Control selection key:”
Baby Mode Control Selection Key

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• The symbol below indicates the Keypad Lock key:
Keypad Lock Key
• The symbol below indicates the Keypad Lock indicator:
Keypad Lock Indicator
• The symbol below indicates the Set Temperature keys:
Set Temperature Keys
• The symbol below indicates the Temperature Override Mode (>37°C) selection key:
Temperature Override Mode (>37°C) Selection Key
• The symbol below indicates the Temperature Override Mode (>37°C) indicator:
Temperature Override Mode (>37°C) Indicator
• The symbol below indicates the Silence/Reset switch:
Silence/Reset
• The symbol below indicates the Power Off/On switch:
Power Off/On
• The symbol below indicates that the cabinet stand doors must remain closed to minimize the risk of
tipping during transport:
Cabinet Stand Doors Must Remain Closed

PROPRIETARY AND CONFIDENTIAL DRAFT 19 Nov 04
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• The symbol below indicates a sensitivity to ELECTROSTATIC DISCHARGE (ESD):
Electrostatic Discharge (ESD)
• The symbol below indicates the surface could be hot.
Caution, Hot Surface
Technical Definitions
•Control zone—A plane 10 cm (4") above the mattress with an area defined by the center of four
quadrants formed by lines that divide the width and length of the mattress surface.
•Incubator temperature—The air temperature at a point 10 cm (4") above and centered over the
mattress surface.
•Average incubator temperature—The average of the maximum and minimum incubator temperature
achieved during steady temperature condition.
•Steady temperature condition—The condition reached when the average incubator temperature does
not vary more than 0.5°C over a period of 1 hour.
•Temperature overshoot—The amount by which the incubator temperature exceeds the average
incubator temperature during steady temperature condition, resulting from a change in temperature.
•Temperature rise time—The time required for the incubator temperature to rise 11°C (20°F).
•Temperature uniformity—The amount by which the average temperature at each of four points
10 cm (4") above the mattress surface differs from the average incubator temperature at steady
temperature condition. The four points are the centers of four quadrants formed by lines that divide the
width and length of the mattress surface.
•Temperature variation—The difference between the incubator temperature and the average incubator
temperature during steady temperature condition.
Intended Use
This manual provides instructions for installation, use, operator maintenance, and troubleshooting of the
Model C400 (discontinued January 2005) and C450 Isolette® Infant Incubator having QT® features, CE
Mark version. Dräger Medical cannot be responsible for the performance of the incubator if the user does
not operate the unit in accordance with the instructions, fails to follow the maintenance recommendations
of the manual, or makes any repairs with unauthorized components. Only qualified service personnel
should perform calibration and repair. Technical information is available through your local distributor.
All personnel who will be working with the unit should read, thoroughly understand, and have ready
access to this manual. Store the manual on the shelf in the cabinet stand when not in use. If there is
anything you do not understand, please contact your technical support representative for further
information.