Air Shields Isolette C2000 and C2000e Instructions for Use Rev 5 Oct 2006

Page 1

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

Page 4

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

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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

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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

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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

Page 8

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]). These are requirements, which are used solely for internal documentation

purposes.

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

1-1

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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:”

Weight Limit

1-2

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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

1-3

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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

1-4

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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 1hour 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.

1-5

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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.

1-6

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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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PROPRIETARY AND CONFIDENTIAL DRAFT 6/29/2006

Notes:

1-8

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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

Line

Back-up

Bypass

2-2

Operating Conditions

AC input normal; load range acceptable; inverter (DC to AC) operational

Loss of AC input; load range acceptable; inverter operational

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

Physical

C2000

Depth

Width

C2000e

Depth

Width

Incubator weight

Mattress tray width

Mattress tray depth

Mattress Trendelenburg/Reverse

Trendelenburg tilt

Electrical

Convenience outlets

(Model C2000, 100V, only)

Convenience outlets (120V)

Convenience outlets (230V)

Chassis current leakage (100V and 120V)

Chassis current leakage (230V)

Environmental

Air mode control temperature range

Air mode control override temperature range

Skin mode control temperature range

Skin mode control override temperature range

Temperature rise time at 22°C (72°F) ambient

Temperature variability

Temperature overshoot

Temperature uniformity with a level mattress

Correlation of the indicated air temperature to

the actual incubator temperature (after the

incubator temperature equilibrium is reached)

Environment temperature operating range

Operating temperature—RH sensor

Operating temperature—oxygen sensor

Operating humidity range

2-6

Dimension

67.31 cm (26.5)

102.9 cm (40.5'')

67.31 cm (26.5")

120 cm (47.25'') (including rail width)

≥ 49 kg (108 lb)

79 cm (31")

41 cm (16")

Continuously variable to 12° ± 1°

100V, 50/60 Hz, 300 W maximum

120V, 50/60 Hz, 300 W maximum

230V, 50/60 Hz, 300 W maximum

≤ 300 µA

≤ 500 µA

20.0°C (68.0°F) to 37.0°C (98.6°F)

37.0°C (98.6°F) to 39.0°C (102.2°F)

34.0°C (93.2°F) to 37.0°C (98.6°F)

37.0°C (98.6°F) to 38.0°C (100.4°F)

< 35 min

< 0.5°C

< 0.5°C maximum

< 0.8°C

≤ 0.8°C

20°C (68°F) to 30°C (86°F)

20°C (68°F) to 41°C (106°F)

20°C (68°F) to 41°C (106°F)

5% to 99% RH non-condensing

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PROPRIETARY AND CONFIDENTIAL DRAFT 6/29/2006

Feature

Noise level within the hood environment

Air velocity over the mattress

Storage temperature

Storage humidity range

Carbon Dioxide (CO2) level

(per EN60601-2-19, Clause 105)

Operational

Set point data retention (non-UPS systems)

Set point data retention (UPS systems)

Dimension

< 47 dBa with 37 dBa or less ambient (less O2

administration)

< 4"/second (10 cm/second); average of five points

at 4" (10 cm) above the mattress

-25°C (-13°F) to 60°C (140°F)

0% to 99% relative humidity non-condensing

<0.5%

power failures lasting <10 min

power failures lasting < (battery charge depletion

time + 10 min)

Options and Accessories

Stands

Feature

Physical

Fixed Height Stand

Top of hood to floor (incubator with FH stand)

Mattress to floor (incubator with FH stand)

Weight (without UPS system and accessories)

Variable Height Stand

Top of hood to floor (incubator with VHA

stand)

Mattress to floor (incubator with VHA stand)

Weight (with UPS system and accessories)

UPS

Battery pack weight

Electrical

Fixed Height Stand

Power requirements for 100V/120 FH stand

(100V for Model C2000, only)

Power requirements for 230V FH stand

Variable-Height Stand

Power requirements for 100/120V VHA stand

(100V for Model C2000 only)

Power requirements for 230V VHA stand

model

UPS

Dimension

142 cm (56") ± 12.7 mm (½")

100.97 cm (39¾") ± 12.7 mm (½")

49.4 kg (109 lb)

133.35 cm (52½") ± 12.7 mm (½") to 152 cm (60")

± 12.7 mm (½")

90.17 cm (35½") ± 12.7 mm (½") to 110½" (43½")

± 12.7 mm (½")

≤ 97 kg (214 lb)

9.5 kg (20.9 lb)

100 V/120 V, 50/60 Hz, 9.9 A maximum

230 V, 50/60 Hz, 9.9 A maximum

Without UPS: 100 V/120 V, 50/60 Hz,

9.9 A maximum

With UPS: 120 V, 50/60 Hz, 11 A maximum

With and without UPS: 230V, 50/60 Hz, 9.9 A

maximum

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PROPRIETARY AND CONFIDENTIAL DRAFT 6/29/2006

Feature

Input current breaker rating

Output circuit breaker rating

Input frequency

Battery type

Operational

UPS charge time

UPS operating time

Dimension

15 A for 120 V; 7A for 230 V

10 A for 120 V; 5 A for 230 V

50/60 Hz (auto sensed by the microprocessor)

45-65 Hz (inverter phase-lock frequency range)

gel cell

Full capacity after 8 hours

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

Humidity System

Humidity control operating time without

refilling

Humidity control reservoir capacity

Humidity control range

Humidity control accuracy between 10% and

90% @ 68°F (20°C) to 104°F (40°C)

Maximum humidity levels

2-8

Dimension

24 hours maximum @ 85% RH and 36°C, in Air

mode

1000 ml

30% to 95% in 1% increments (at high ambient

humidity levels, low level humidity settings may

not be attainable)

± 6% RH

>85% (incubator set temp at 39°C, with at least

30% RH at ambient)

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PROPRIETARY AND CONFIDENTIAL DRAFT 6/29/2006

Oxygen System

Feature

Oxygen Control System

Oxygen inlet pressure

Oxygen inlet flow rate

Oxygen control range

Oxygen display resolution

Oxygen control accuracy at 100%

calibration

Oxygen control accuracy at 21%

calibration

Dimension

40 psi to 150 psi

30 liters/min

21% to 65%

1% increments

± 3%

± 5%

Non-EU Weighing System

Feature

Weighing System

Weight display range

Weight display resolution

Weight display accuracy

Maximum tare weight

Dimension

0 kg (0 lb) to 7 kg (15 lb)

1.0 g or 0.04 oz

0 - 2 kg; 2 g ± ½ digit

> 2 kg; ±5 g ± ½ digit

4.0 kg (8.82 lb) ±0.5 kg

EU Weighing System

Feature

Weighing System

Maximum capacity

Minimum capacity

Maximum tare weight

Verification scale interval

Scale level sensitivity

Weight display accuracy

Weight display update rate

Weight display resolution

Dimension

7 kg (15lb)

200 g (.44 lb)

4.0 kg (8.82 lb) ± 0.5 kg

10 g (.022 lb)

90 min (1 min=1/60 degree)

10 g (.022 lb)

1s

10 g (.022 lb)

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PROPRIETARY AND CONFIDENTIAL DRAFT 6/29/2006

Rail Accessory Weight Limitations

Feature

Rail system assembly

Monitor shelf assembly, high/low, C2000e

I.V. pole assembly, C2000e

Basket 18.0 W x 9.5 D x 4.0 H

Basket 6.5 W x 4.0 D x 5.0 H

Basket 11.0 W x 4.0 D x 4.0 H

Basket - pivoting

Chart holder

Hinged mayo tray, 13.5 W x 9.75 D

Hinged mayo tray, 17.0 W x 11.5 D

Cable organizer

Horizontal cord wrap

Standard cam adapter

Ball action adapter

Double cam adapter

Cam adapter, threaded mount

Utility hook assembly

Reading lamp

NCL examination lamp

Holder for litter bags, including 100 litter bags

Basket 150, for disposable gloves

Basket 300, for 300 mm catheters

Basket 600, for 600 mm catheters

Tray 3020

Dimension

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)

11 kg (25 lb)

5 kg (11 lb)

4.4 kg (10 lb)

2.2 kg (5 lb)

2.2 kg (5 lb)

2.2 kg (5 lb)

2.2 kg (5 lb)

2.2 kg (5 lb)

2.2 kg (5 lb)

2.2 kg (5 lb)

2.2 kg (5 lb)

2.2 kg (5 lb)

2.2 kg (5 lb)

2.2 kg (5 lb)

2.2 kg (5 lb)

1.3 kg (2.9 lb)

1.7 kg (3.8 lb)

0.680 kg (1.5 lb)

0.346 kg (0.763 lb)

0.433 kg (0.954 lb)

0.635 kg (1.4 lb)

1.2 kg (2.6 lb)

Non-Rail Accessory Weight Limitations

Feature

Monitor shelf assembly, high, C2000e

Monitor shelf assembly, low, C2000e

I.V. pole assembly, C2000e

Tray assembly, large

Swivel drawer assembly, large

Swivel drawer assembly, small

Swivel drawer assembly, small, C2000e

Drawer housing assembly, shallow, short

2 - 10

Dimension

11 kg (25 lb)

11 kg (25 lb)

5 kg (11 lb)

17.6 kg (40 lb)

Tray - 0.91 kg (2 lb)

Drawer - 4.5 kg (10 lb)

Tray - 0.91 kg (2 lb)

Drawer - 2.2 kg (5 lb)

Tray - 0.91 kg (2 lb)

Drawer - 2.2 kg (5 lb)

2.2 kg (5 lb)