Drager C2000 User manual
Air Shields® Isolette® Infant Incubator
WARNING:
For a full understanding of the performance
characteristics of this equipment, the user
should carefully read this manual before
operating.
Models C2000 and C2000e
Operating Instructions
Table of Contents
Section 1: Definitions, Intended Use, and Disclaimer
Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Technical Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Disclaimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Section 2: Introduction, Features, and Specifications
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Humidity System (Optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Humidity Reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Manifold Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Evaporator Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Oxygen Control System (Optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Weighing System (Accessory) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Non-EU Scales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
EU Scales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Uninterruptible Power Supply (UPS) (Optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Functional Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Air Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Skin Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4
Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Standard Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Optional Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Standard Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Options and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Stands . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Humidity System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Oxygen System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Non-EU Weighing System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
EU Weighing System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Rail Accessory Weight Limitations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
Non-Rail Accessory Weight Limitations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
Regulations, Standards, and Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
i
Electromagnetic Compatibility (EMC) Guidance and Manufacturer Declarations . . . . . . 2-12
Device Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15
Section 3: Precautions and Safety Tips
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Electrical Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Explosion Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
EMC Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Oxygen Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Humidity Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Safety Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Section 4: Installation and Operational Checkout
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Unpackaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
C2000 Stand Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
C2000e Stand Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Rail Assembly and Accessories Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Integris (Fairfield Compatible) Rail Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Deutsche Institute von Normen (DIN) Rail Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Rail Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Hood, Shell, and Stand Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Mattress Restraint Strap Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9
UPS System Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Weighing System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Non-EU Scale Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
EU Scale Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
Humidity System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
Oxygen Control System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
Oxygen Sensor Cells . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
Oxygen Calibration Fixture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14
Operational Checkout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
Controller Operational Checkout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
Hood/Shell Operational Checkout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17
VHA Stand Operational Checkout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20
UPS System Operational Checkout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21
Check On/Off/Test Switch and Low Battery Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21
Test Battery Back-up Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22
Rail System Operational Checkout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22
Oxygen Control Module Operational Checkout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22
ii
Humidity System Operational Checkout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23
Weighing System Operational Checkout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23
Non-EU Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23
EU Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24
Section 5: Instructions for Use
Controls, Indicators and Connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Incubator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Incubator Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Hardkeys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Softkeys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Incubator Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Incubator Connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-4
Controller Interface Connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Serial Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Sensor Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Sensor Module Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Sensor Module Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Sensor Module Connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Stand Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Main Circuit Breaker . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Foot Pedal Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Stand Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Stand Connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Convenience Outlet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
AC Input Connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
UPS Electronic Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
UPS Electronic Module Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
UPS Electronic Module Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
UPS Electronic Module Connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
Displays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
Temperature Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
Trend/Alarm Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
Humidity Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-9
Oxygen Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-9
System Displays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
Temperature Displays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
Trend Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
iii
Weight Displays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
Oxygen Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
Humidity Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
Factory Default Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13
System Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13
UPS Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17
System Prompts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17
Infant Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-19
Operating Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-20
System Start-Up and Shut-Down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-20
System Start-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-20
Initial Start-up for systems without UPS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-20
Initial Start-up for systems with UPS (Model C2000e only) . . . . . . . . . . . . . . . . . . . . 5-20
Recovery from Power Failure for non-UPS systems . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21
Recovery from Power Failure for UPS systems (Model C2000e only) . . . . . . . . . . . . 5-21
System Shut Down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21
System Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-22
Variable Height Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-23
Temperature Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-23
Air Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-24
Skin Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-24
Controller Screen Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-25
Skin Probe Attachment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-26
Single Temperature Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-26
Dual Temperature Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-27
Data Trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-27
Scale Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-28
Non-EU Scale Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-28
Initial Weigh . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-28
Re-weigh . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-29
EU Scale Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-29
Oxygen Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-30
Oxygen Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-30
Oxygen Control Set Point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31
Humidity Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31
Humidity Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-31
Humidity Control Set Point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-32
iv
VueLink™ Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-32
X-Ray Tray Usage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-33
Non-Servo Control Oxygen Usage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-33
Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-34
Scale Calibration for the Non-EU Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-34
Oxygen Sensor Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-36
Oxygen Sensor Calibration to Room Air (21%) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-36
Oxygen Sensor Calibration to 100% Oxygen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-37
Patient Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-38
Section 6:Cleaning, Maintenance, and Replacement Parts
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
General Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Steam Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Stain Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Disassembly for Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Mattress Tray, X-Ray Tray, Main Deck, Scale (optional) . . . . . . . . . . . . . . . . . . . . . . . 6-3
Heater and Impeller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Humidity Tray and Reservoir (Non-CPC). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Humidity Tray and Reservoir (CPC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Access Door Gaskets, Tubing, Iris Entry Port Sleeves, Cuffs . . . . . . . . . . . . . . . . . . . . 6-4
Air Intake Microfilter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Cleaning Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Reusable Skin Temperature Probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Access Door Gaskets and Tubing Access Ports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Controller, Shell, and Stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Sensor Module, Hood, and Inner Walls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Heater Radiator and Fan Impeller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Humidity Reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Air Intake Microfilter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Base Covers, Rail and Accessories, Drawers, Tank Mounts,
Monitor Shelf, and I.V. Pole . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Mattress, Mattress Tray, X-Ray Tray, Main Deck, Heater/Impeller Cover,
Scale (Optional), and Mattress Tilt Bars . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Uninterruptible Power Supply (UPS) Air Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Reassembly After Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10
v
UPS Battery Pack Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10
UPS Electronics Module Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Air Intake Microfilter Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Replacement Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12
Section 7: Troubleshooting 1
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Symptom, Cause, and Remedy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
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PROPRIETARY AND CONFIDENTIAL DRAFT 6/29/2006
Section 1
Definitions, Intended Use,
and Disclaimer
Definitions
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 Definitions subsection contains label symbol definitions and technical definitions. Additional
definitions of system symbols and icons are located in Section 5 (see “Controls, Indicators, and
Connectors” on page 5-1).
Some of the warnings contained in this user manual include number tags or bracketed wording (for
example [6.8.2.9] or [IHA025])
purposes.
. These are requirements, which are used solely for internal documentation
Symbol Definitions
• 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 an ELECTRICAL SHOCK HAZARD WARNING:
Electrical Shock Hazard Warning
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PROPRIETARY AND CONFIDENTIAL DRAFT 6/29/2006
• The symbol below indicates “Attention: Consult accompanying documents:”
Attention: Consult Accompanying Documents
• The symbol below indicates a “Type BF applied part:”
Type BF Applied Part
– The instrument provides a specified degree of protection against electric shock, particularly the
leakage current and reliability of the protective ground connection with a BF-type applied part.
– A BF-type applied part indicates an applied part isolated from all other parts of the instrument to
such a degree that the patient leakage current allowable in a single-fault condition is not
exceeded.
• The symbol below indicates “AC power:”
AC Power
• The symbol below indicates “Protective earth (ground):”
Protective Earth (Ground)
• The symbol below indicates “Caution: Hot surface:”
Caution: Hot Surface
• The symbol below indicates “Weight limit:”
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Weight Limit
PROPRIETARY AND CONFIDENTIAL DRAFT 6/29/2006
• The symbol below indicates “Consult Accompanying Document on the Battery Weight:”
Battery Weight
• The symbol below indicates “Consult Accompanying Document on Battery Pack Orientation:”
Battery Pack Orientation
• The symbol below indicates “Power Failure:”
Power Failure
• The symbol below indicates “Lock casters when parked on an incline:”
Lock Casters
• The symbol below indicates an ELECTROSTATIC DISCHARGE (ESD) sensitive part:
Electrostatic Discharge (ESD) Sensitive Part
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PROPRIETARY AND CONFIDENTIAL DRAFT 6/29/2006
• The symbol below indicates “Consult accompanying documents on latch lock/unlock and rail
loading:”
Latch Lock/Unlock and Rail Loading
• The symbol below indicates “Electromagnetic interference:”
Electromagnetic Interference
Interference can occur in the vicinity of the equipment marked with the Electromagnetic
Interference symbol.
• The symbol below indicates “Consult accompanying document on the large tray loading:”
large Tray Loading
• The symbol below indicates a “Communication port:”
Communication Port
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PROPRIETARY AND CONFIDENTIAL DRAFT 6/29/2006
Technical Definitions
• Incubator temperature—Air temperature at a point 4" (10 cm) above and centered over the mattress
surface.
• Control temperature—The temperature controller set point selected by the user.
• Average incubator temperature—The average of the maximum and minimum incubator
temperatures achieved during temperature equilibrium.
• Incubator temperature equilibrium—The condition reached when the average temperature of the
incubator does not vary more than 1°C over a period of 1 hour.
• Temperature uniformity—The amount by which the average temperatures at each of four points 4"
(10 cm) above the mattress surface differs from the average incubator temperature at incubator
temperature equilibrium.
• Temperature variability—The variability of the incubator temperature that will be observed over a 1-
hour period after incubator temperature equilibrium has been reached.
• Temperature rise time—The time required for the incubator temperature to rise 20°F (11°C), when
the air control temperature is at least 22°F (12°C) above the ambient temperature.
• Temperature overshoot—The amount by which the incubator temperature exceeds the average
incubator temperature at incubator temperature equilibrium as a result of an increase in control
temperature.
• Temperature correlation—Temperature indicator versus incubator temperature—The amount
the air temperature indicator at incubator temperature equilibrium differs from the incubator
temperature.
• Control correlation—Incubator temperature versus control temperature—The amount the
average incubator temperature in Air mode at incubator temperature equilibrium differs from the
control temperature.
• Control accuracy—Temperature indicator versus control temperature—The amount the air
temperature indicator in Air mode at incubator temperature equilibrium differs from the control
temperature.
• Measurement points—Measurements are taken at five points in a plane parallel to and 4" (10 cm)
above the mattress surface. One point is 4" (10 cm) above the center of the mattress, the remaining four
points are the centers of the four areas formed by lines that divide both the width and length in two
parts.
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PROPRIETARY AND CONFIDENTIAL DRAFT 6/29/2006
Intended Use
This manual provides an overall functional description and the instructions for use of the Isolette® Infant
Incubator, Models C2000 and C2000e.
The Isolette® Infant Incubator, Models C2000 and C2000e should be used only by appropriately trained
personnel and under the direction of qualified medical personnel.
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PROPRIETARY AND CONFIDENTIAL DRAFT 6/29/2006
Disclaimer
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, or makes
any repairs with unauthorized components. Only qualified service personnel should calibrate and repair
it. Technical information is available through local distributors.
All personnel working with the unit should read, thoroughly understand, and have ready access to this
manual. Store the manual with the incubator when not in use. Please contact your local representative for
clarity or further information.
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Notes:
PROPRIETARY AND CONFIDENTIAL DRAFT 6/29/2006
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PROPRIETARY AND CONFIDENTIAL DRAFT 6/29/2006
Section 2
Introduction, Features,
and Specifications
Introduction
The Introduction subsection provides a system overview and functional description of the Isolette®
Infant Incubator, Models C2000 and C2000e.
System Overview
The Isolette® Infant Incubator, Models C2000 and C2000e is a modular controller-based incubator,
which enables simultaneous control of temperature, oxygen, and humidity parameters affecting the
infant. The incubator hood and shell assemblies are mounted on a variable height adjustable (VHA) stand
or fixed height (FH) stand.
The Isolette® Infant Incubator, Models C2000 and C2000e supports electro luminescent (EL) and liquid
crystal display (LCD) display technology.
Humidity System (Optional)
When installed, the built-in humidifier provides humidification of the incubator from 30% to 95%
relative humidity (RH) in 1% increments. When the humidity system senses an absence of water an
audible and visual Low Humidity alarm occurs. The humidifier is a three-part system consisting of a
humidity reservoir, manifold assembly, and evaporator assembly.
Humidity Reservoir
The humidity reservoir has a 1 liter capacity. The reservoir permits visual inspection of the water level. It
is located in a drawer in the front of the incubator shell. When the drawer is closed and the latching
handle is engaged, the reservoir is connected to a manifold.
Manifold Assembly
The manifold assembly allows the water to flow into the metering valve and the evaporator assembly.
Evaporator Assembly
The metering valve regulates the flow of water to the evaporator chamber to maintain a constant level of
water, ensuring optimum responsiveness of the evaporator heater. The evaporator assembly raises the
temperature of the water to the boiling point, causing vaporization. Any waterborne bacteria are killed,
preventing transfer into the patient compartment. The rate of vaporization is determined by the level of
power transmitted to the evaporator heater. The sensor module located within the hood environment
houses the humidity sensor, which sends information to the controller module. The controller module
regulates the output of the evaporator.
Oxygen Control System (Optional)
When installed, the oxygen (servo) control system adjusts the flow of oxygen within the incubator hood
with a valve and an oxygen sensor module. The sensor module houses two independent oxygen fuel cells.
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PROPRIETARY AND CONFIDENTIAL DRAFT 6/29/2006
When the sensor module is outside of the hood during Oxygen Control mode, audible and visual alarms
are enabled and the flow of oxygen is interrupted.
Weighing System (Accessory)
When installed, the weighing system is located in a platform under the mattress. The scale contains two
load beams, which perform the actual weighing function. The controller processes the load beam
information and displays the weight in kilograms or pounds in the Trend/Alarm window.
System prompts are displayed in the Trend/Alarm window during the weighing procedure.
Non-EU Scales
The Weight softkey allows for repeated re-weighing of the infant after the weighing routine has been
initiated.
EU Scales
Since the weighing routine is continuous, no re-weigh function is required to update the weight
measurements.
Uninterruptible Power Supply (UPS) (Optional)
When installed, the UPS system provides
an on-line uninterruptible back-up power
supply to the incubator, which can also be
used for intra-facility transport.
With batteries fully charged, the power
available from battery backup is sufficient
to maintain a C2000e incubator in
operation for 30 min in a 20°C ambient at a
set point of 39°C in the Air mode, without
oxygen or humidity control, or additional
loads drawn from the accessory outlets.
Battery back-up usage occurs during power
failure or while transporting an unplugged
incubator within the facility.
The UPS system consists of two main components: the electronics control module and the battery pack
module. The battery pack module consists of three sealed gel cell batteries that are charged by the
electronics module. The electronics module is responsible for monitoring, distributing, and controlling
the power delivered to the incubator.
The UPS system operates in three modes: line, back-up and bypass. Refer to the table below:
Modes Operating Conditions
Line AC input normal; load range acceptable; inverter (DC to AC) operational
Back-up Loss of AC input; load range acceptable; inverter operational
Bypass Loss of inverter output; acceptable load; power supplied from AC only
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PROPRIETARY AND CONFIDENTIAL DRAFT 6/29/2006
Functional Description
The temperature, humidity, and oxygen concentration is
controlled by the forced air circulation system. A controlled
amount of room air, approximately 7 lpm, is drawn through
the air intake filter by the motor-driven impeller located in
the shell.
The impeller internally recirculates air at a much greater flow
than that of the fresh gas inflow. The total inflow of fresh and
re-circulated air is directed around the heater. The air enters
the infant compartment up through the slots at the front and
rear of the main deck. It then passes between the front and
rear inner walls. The air circulates past the sensor module
containing the temperature sensing probe, which
encapsulates the air temperature control thermistor and a
high air temperature alarm thermistor. After circulating
within the infant compartment, the air is then re-circulated down through a slot in the right end of the
main deck, and back to the impeller. When the front and/or rear access panel(s) of the hood is/are open,
the air continues to flow upward past the opening, creating a warm air curtain. This curtain minimizes the
drop in air temperature within the incubator.
Temperature is regulated by using either incubator air or skin temperature. The front panel keys enable
the user to select the desired Air or Skin mode.
In either mode of operation, the heater output is proportional to the amount of heat required to maintain
the desired temperature. The Air and Skin modes are described below.
Air Mode
In the Air mode, the air temperature can be maintained from 20.0°C (68.0°F) to 37.0°C (98.6°F) as
selected by the Up and Down Arrow keys on the front panel. In Temperature Override mode, the
temperature can be maintained from 37.0°C (98.6.0°F) to 39.0°C (102.2°F).
The incubator air temperature is monitored by a probe located in the sensor module and compared with
the air set temperature parameter. The information from this probe is supplied to the heater control
circuitry, which regulates the heater output to maintain the air temperature setting. The actual air
temperature is shown in the Temperature window. A second sensor within the air temperature probe
serves as a backup to limit the maximum incubator temperature. If the high temperature limit is reached,
the heater shuts off.
The infant temperature is a function of: 1) the air temperature and 2) the ability of the infant to establish
and maintain his/her own temperature. A small infant, or one with underdeveloped homeostatic control,
may not be able to maintain a stable temperature at the desired level.
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PROPRIETARY AND CONFIDENTIAL DRAFT 6/29/2006
Skin Mode
In the Skin mode, the Up and Down Arrow keys on the controller front panel are used to select the infant
temperature from 34.0°C (93.2°F) to 37.0°C (98.6°F). In Temperature Override mode, the temperature
can be selected from 37.0°C (98.6°F) to 38.0°C (100.4°F).
A temperature sensing probe is attached directly to the skin of the infant. The information from the probe
is supplied to the heater control circuitry, which proportions the heater output to maintain the skin set
temperature.
The air temperature is still shown in Skin mode, but for information purposes only. If the Air mode is
selected while the skin probe remains connected, the skin temperature parameter continues to display the
actual skin temperature. However, it does not control the incubator temperature.
The sensor module is equipped to accept two skin probes. To control the incubator temperature in the skin
mode, insert a skin probe into the skin probe 1 connector (see “Controls, Indicators, and Connectors” on
page 5-1). When a second skin probe is connected to the sensor module while operating in the skin mode,
an alarm sounds and the message Remove Skin 2 Probe is displayed. To connect a second skin probe,
select the Air mode first. The controller then displays the respective Skin 1 and Skin 2 temperatures
monitored by the skin probes.
If Probe 1 is disconnected from its receptacle while in the Skin mode, the skin temperature parameter
goes blank on the display, an alarm sounds, and the heater turns off.
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PROPRIETARY AND CONFIDENTIAL DRAFT 6/29/2006
Features
The Features subsection provides a list of the standard and optional features and available accessories for
the Isolette® Infant Incubator, Models C2000 and C2000e.
Standard Features
Standard features include:
• Oval access doors with a quiet latch
• Trendelenberg mattress tilt mechanism (0° to 12°)
• Pedestal base cover (C2000e, only)
• Rail system (C2000e, only)
Optional Features
Options include:
• Oxygen control system
• Humidity system
• Fixed height stand (without UPS system)
• VHA stand (without UPS system)
C2000e only
• Fixed height stand (with UPS system)
• VHA stand (with UPS system)
Accessories
Accessories include:
• Weighing system
• Ventilation support
• Temperature probes
• Port sleeves and cuffs
• 5 kg weight
• Gas tank mounts and tanks (E and D sizes)
C2000e only
• Deutsche Institute von Normen (DIN) and Integris/Fairfield rail mounted accessories
C2000 only
• Non-rail mounted accessories
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PROPRIETARY AND CONFIDENTIAL DRAFT 6/29/2006
≤
≤
Specifications
The Specifications subsection provides specifications for the standard and optional features and
available accessories of the Isolette® Infant Incubator, Models C2000, and C2000e. It also includes
regulation and standards and codes information for the system.
Standard Features
Feature Dimension
Physical
C2000
Depth 67.31 cm (26.5)
Width 102.9 cm (40.5'')
C2000e
Depth 67.31 cm (26.5")
Width 120 cm (47.25'') (including rail width)
Incubator weight 49 kg (108 lb)
Mattress tray width 79 cm (31")
Mattress tray depth 41 cm (16")
Mattress Trendelenburg/Reverse
Trendelenburg tilt
Electrical
Convenience outlets
(Model C2000, 100V, only)
Convenience outlets (120V) 120V, 50/60 Hz, 300 W maximum
Convenience outlets (230V) 230V, 50/60 Hz, 300 W maximum
Chassis current leakage (100V and 120V) 300 µA
≥
Continuously variable to 12° ± 1°
100V, 50/60 Hz, 300 W maximum
Chassis current leakage (230V) 500 µA
Environmental
Air mode control temperature range 20.0°C (68.0°F) to 37.0°C (98.6°F)
Air mode control override temperature range 37.0°C (98.6°F) to 39.0°C (102.2°F)
Skin mode control temperature range 34.0°C (93.2°F) to 37.0°C (98.6°F)
Skin mode control override temperature range 37.0°C (98.6°F) to 38.0°C (100.4°F)
Temperature rise time at 22°C (72°F) ambient < 35 min
Temperature variability < 0.5°C
Temperature overshoot < 0.5°C maximum
Temperature uniformity with a level mattress < 0.8°C
Correlation of the indicated air temperature to
the actual incubator temperature (after the
incubator temperature equilibrium is reached)
Environment temperature operating range 20°C (68°F) to 30°C (86°F)
Operating temperature—RH sensor 20°C (68°F) to 41°C (106°F)
Operating temperature—oxygen sensor 20°C (68°F) to 41°C (106°F)
Operating humidity range 5% to 99% RH non-condensing
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0.8°C
≤
PROPRIETARY AND CONFIDENTIAL DRAFT 6/29/2006
Feature Dimension
Noise level within the hood environment < 47 dBa with 37 dBa or less ambient (less O2
administration)
Air velocity over the mattress < 4"/second (10 cm/second); average of five points
at 4" (10 cm) above the mattress
Storage temperature -25°C (-13°F) to 60°C (140°F)
Storage humidity range 0% to 99% relative humidity non-condensing
Carbon Dioxide (CO2) level
<0.5%
(per EN60601-2-19, Clause 105)
Operational
Set point data retention (non-UPS systems) power failures lasting <10 min
Set point data retention (UPS systems) power failures lasting < (battery charge depletion
time + 10 min)
Options and Accessories
Stands
Feature Dimension
Physical
Fixed Height Stand
Top of hood to floor (incubator with FH stand) 142 cm (56") ± 12.7 mm (½")
Mattress to floor (incubator with FH stand) 100.97 cm (39¾") ± 12.7 mm (½")
Weight (without UPS system and accessories) 49.4 kg (109 lb)
Variable Height Stand
Top of hood to floor (incubator with VHA
stand)
133.35 cm (52½") ± 12.7 mm (½") to 152 cm (60")
± 12.7 mm (½")
Mattress to floor (incubator with VHA stand) 90.17 cm (35½") ± 12.7 mm (½") to 110½" (43½")
± 12.7 mm (½")
Weight (with UPS system and accessories)
≤
97 kg (214 lb)
UPS
Battery pack weight 9.5 kg (20.9 lb)
Electrical
Fixed Height Stand
Power requirements for 100V/120 FH stand
100 V/120 V, 50/60 Hz, 9.9 A maximum
(100V for Model C2000, only)
Power requirements for 230V FH stand 230 V, 50/60 Hz, 9.9 A maximum
Variable-Height Stand
Power requirements for 100/120V VHA stand
(100V for Model C2000 only)
Without UPS: 100 V/120 V, 50/60 Hz,
9.9 A maximum
With UPS: 120 V, 50/60 Hz, 11 A maximum
Power requirements for 230V VHA stand
model
With and without UPS: 230V, 50/60 Hz, 9.9 A
maximum
UPS
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PROPRIETARY AND CONFIDENTIAL DRAFT 6/29/2006
Feature Dimension
Input current breaker rating 15 A for 120 V; 7A for 230 V
Output circuit breaker rating 10 A for 120 V; 5 A for 230 V
Input frequency 50/60 Hz (auto sensed by the microprocessor)
45-65 Hz (inverter phase-lock frequency range)
Battery type gel cell
Operational
UPS charge time Full capacity after 8 hours
UPS operating time With batteries fully charged, the power available
from battery backup is sufficient to maintain a
C2000e incubator in operation for 30 min in a
20°C ambient at a set point of 39°C in the Air
mode, without oxygen or humidity control, or
additional loads drawn from the accessory outlets.
Humidity System
Feature Dimension
Humidity System
Humidity control operating time without
refilling
Humidity control reservoir capacity 1000 ml
Humidity control range 30% to 95% in 1% increments (at high ambient
Humidity control accuracy between 10% and
90% @ 68°F (20°C) to 104°F (40°C)
Maximum humidity levels >85% (incubator set temp at 39°C, with at least
24 hours maximum @ 85% RH and 36°C, in Air
mode
humidity levels, low level humidity settings may
not be attainable)
± 6% RH
30% RH at ambient)
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PROPRIETARY AND CONFIDENTIAL DRAFT 6/29/2006
Oxygen System
Feature Dimension
Oxygen Control System
Oxygen inlet pressure 40 psi to 150 psi
Oxygen inlet flow rate 30 liters/min
Oxygen control range 21% to 65%
Oxygen display resolution 1% increments
Oxygen control accuracy at 100%
calibration
Oxygen control accuracy at 21%
calibration
Non-EU Weighing System
Feature Dimension
Weighing System
Weight display range 0 kg (0 lb) to 7 kg (15 lb)
Weight display resolution 1.0 g or 0.04 oz
Weight display accuracy 0 - 2 kg; 2 g ± ½ digit
Maximum tare weight 4.0 kg (8.82 lb) ±0.5 kg
± 3%
± 5%
> 2 kg; ±5 g ± ½ digit
EU Weighing System
Feature Dimension
Weighing System
Maximum capacity 7 kg (15lb)
Minimum capacity 200 g (.44 lb)
Maximum tare weight 4.0 kg (8.82 lb) ± 0.5 kg
Verification scale interval 10 g (.022 lb)
Scale level sensitivity 90 min (1 min=1/60 degree)
Weight display accuracy 10 g (.022 lb)
Weight display update rate 1 s
Weight display resolution 10 g (.022 lb)
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PROPRIETARY AND CONFIDENTIAL DRAFT 6/29/2006
Rail Accessory Weight Limitations
Feature Dimension
Rail system assembly Total rail accessory weight not to exceed 36.3 kg
(80 lb); 13.1 kg (40 lb) per side rail or 6.8 kg (15
lb) per front and rear rail (with remaining weight
distributed along side rails)
Monitor shelf assembly, high/low, C2000e 11 kg (25 lb)
I.V. pole assembly, C2000e 5 kg (11 lb)
Basket 18.0 W x 9.5 D x 4.0 H 4.4 kg (10 lb)
Basket 6.5 W x 4.0 D x 5.0 H 2.2 kg (5 lb)
Basket 11.0 W x 4.0 D x 4.0 H 2.2 kg (5 lb)
Basket - pivoting 2.2 kg (5 lb)
Chart holder
Hinged mayo tray, 13.5 W x 9.75 D 2.2 kg (5 lb)
Hinged mayo tray, 17.0 W x 11.5 D 2.2 kg (5 lb)
Cable organizer 2.2 kg (5 lb)
Horizontal cord wrap 2.2 kg (5 lb)
Standard cam adapter 2.2 kg (5 lb)
Ball action adapter 2.2 kg (5 lb)
Double cam adapter 2.2 kg (5 lb)
Cam adapter, threaded mount 2.2 kg (5 lb)
Utility hook assembly 2.2 kg (5 lb)
Reading lamp 1.3 kg (2.9 lb)
NCL examination lamp 1.7 kg (3.8 lb)
Holder for litter bags, including 100 litter bags 0.680 kg (1.5 lb)
Basket 150, for disposable gloves 0.346 kg (0.763 lb)
Basket 300, for 300 mm catheters 0.433 kg (0.954 lb)
Basket 600, for 600 mm catheters 0.635 kg (1.4 lb)
Tray 3020 1.2 kg (2.6 lb)
Non-Rail Accessory Weight Limitations
Feature Dimension
Monitor shelf assembly, high, C2000e 11 kg (25 lb)
Monitor shelf assembly, low, C2000e 11 kg (25 lb)
I.V. pole assembly, C2000e 5 kg (11 lb)
Tray assembly, large 17.6 kg (40 lb)
Swivel drawer assembly, large Tray - 0.91 kg (2 lb)
Drawer - 4.5 kg (10 lb)
Swivel drawer assembly, small Tray - 0.91 kg (2 lb)
Drawer - 2.2 kg (5 lb)
Swivel drawer assembly, small, C2000e Tray - 0.91 kg (2 lb)
Drawer - 2.2 kg (5 lb)
Drawer housing assembly, shallow, short 2.2 kg (5 lb)
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PROPRIETARY AND CONFIDENTIAL DRAFT 6/29/2006
Feature Dimension
Drawer housing assembly, shallow, long 2.2 kg (5 lb)
Swivel drawer assembly, large, C2000e Tray - 0.91 kg (2 lb)
Drawer - 4.5 kg (10 lb)
Drawer housing assembly, deep, short 4.5 kg (10 lb)
Drawer housing assembly, deep, long 4.5 kg (10 lb)
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PROPRIETARY AND CONFIDENTIAL DRAFT 6/29/2006
Regulations, Standards, and Codes
The Isolette® Infant Incubator, Models C2000 and C2000e complies with the following safety standards
and performance standards:
• EN 60601-1—1990, Medical Electrical Equipment, Part 1: General Requirements for Safety,
including Amendments 1 and 2
• EN 60601-1-2—2002, Collateral Standard: Electromagnetic Compatibility—Requirements and Tests
• EN 60601-2-19—1996, Particular Requirements for the Safety of Baby Incubators, including
Amendment 1
Electromagnetic Compatibility (EMC) Guidance and Manufacturer Declarations
Guidance and Manufacturer’s Declaration— Emissions
The C2000 is intended for use in the electromagnetic environment specified below. The customer or
user of the unit should ensure that the unit is used in such an environment.
Emissions Test Compliance Electromagnetic Environment—Guidance
Radio frequency (RF)
emissions—CISPR 11
RF emissions
CISPR 11
Harmonics
IEC 61000-3-2
Flicker
IEC 61000-3-3
Group 1 The C2000 uses RF energy only for its internal
function. Therefore, its RF emissions are very
low and are not likely to cause interference with
nearby electronic equipment.
Class A The C2000 is suitable for use in all establish-
ments, including domestic, and those directly
Class A
connected to the public low-voltage power supply network that supplies buildings used for
Class A
domestic purposes.
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PROPRIETARY AND CONFIDENTIAL DRAFT 6/29/2006
Guidance and Manufacturer’s Declaration—Immunity
The C2000 is intended for use in the electromagnetic environment specified below. The customer or user of the
C2000 should ensure that the unit is used in such an environment.
Immunity Test
ESD
IEC 61000-4-2
EFT
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage Dips/Dropout
IEC 61000-4-11
IEC 60601 Test
Level
± 6 kV contact
± 8 kV air
± 2 kV Mains
± 1 kV I/Os
± 1 kV Differential
± 2 kV Common
> 95% dip for 0.5
cycle
60% dip for 5 cycle
30% dip in for 25
cycles
Compliance Level
± 6 kV contact
± 8 kV air
± 2 kV Mains
No I/Os
± 1 kV Differential
± 2 kV Common
> 95% dip for 0.5
cycle
60% dip for 5 cycle
30% dip in for 25
cycles
Electromagnetic Environment—
Guidance
The floors should be wood, concrete, or
ceramic tile. If floors are covered with
synthetic, the relative humidity should be
at least 30%.
Mains power quality should be that of a
typical commercial or hospital
environment.
Mains power quality should be that of a
typical commercial or hospital
environment.
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the C2000
requires continued operation during power
mains interruptions, it is recommended
that the C2000 be powered from an
uninterruptible power supply or battery.
Power frequency
50/60 Hz
Magnetic field
IEC 61000-4-8
> 95% dip for 5 seconds
3 A/m 3 A/m Power frequency magnetic fields should
> 95% dip for 5 seconds
be that of a typical commercial or hospital
environment.
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PROPRIETARY AND CONFIDENTIAL DRAFT 6/29/2006
D
Guidance and Manufacturer’s Declaration— Immunity
The C2000 is intended for use in the electromagnetic environment specified below. The customer or user of the C2000
should ensure that the unit is used in such an environment.
Immunity
Test
Conducted
RF
IEC 61000-46
IEC 60601
Test Level
3 Vrms (outside ISM)
20Vrms (in
ISM bands)
150 KHz to
80 MHz
Compliance
Level
V1=3 Vrms
V2=10 Vrms
Electromagnetic Environment—Guidance
Recommended Separation Distance
Portable and mobile communications equipment should be separated from
the C2000 by no less than the distances calculated/listed below:
1.167 P=
D 1.2 P=
outside ISM
in ISM
Radiated RF
IEC 61000-43
10 V/m E1=10 V/m
80 MHz to
2.5 GHz
D 1.2 P=
D 2.3 P=
where P is the maximum power in watts and D is the recommended
separation distance in meters.
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey, should be less than the compliance levels (V1,
V2, and E).
80 MHz to 800 MHz
800 MHz to 2.5 GHz
Recommended Separations Distances for the C2000
The C2000 is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the C2000 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the C2000 as recommended,
according to the maximum output power of the communications equipment.
Maximum Output
Power
(Watts)
Separation (m)
150 kHz to
80 MHz
Non-ISM
D 1.167 P= D 1.2 P=
Separation (m)
150 kHz to
80 MHz
ISM
Separation (m)
80 to 800 MHz
D 1.2 P=
Separation (m)
800 MHz to
2.5 GHz
D 2.3 P=
0.01 0.1167 m 0.12 m 0.12 m 0.23 m
0.1 0.369 m 0.38 m 0.38 m 0.73 m
1 1.167 m 1.2 m 1.2 m 2.3 m
10 3.69 m 3.8 m 3.8 m 7.3 m
100 11.67 m 12 m 12 m 23 m
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