Medtronic 5016000 Operator's Manual

WarmTouch™

Convective Warming System

Operator's Manual

U.S. patents: www.medtronic.com/patents

COVIDIEN, COVIDIEN with logo, and Covidien logo and Positive Results for Life are U.S. and internationally registered trademarks of
Covidien AG. ™* brands are trademarks of their respective owner. Other brands are trademarks of a Covidien company.

Symbols

0123

By prescription only (appears on unit and on shipping label)

No free hosing: Hose nozzle must be connected to a WarmTouch™ blanket or thermal injury may occur (appears on
unit only)

Do not use during magnetic resonance imaging (MRI) (appears on unit and on shipping label)

Degree of protection from electric shock: Protection Class I, Type BF applied part (appears on unit only)

Recommendation to consult accompanying documents (appears on unit and on shipping label)

Requirement to consult accompanying documents (appears on unit and on shipping label)

Nature of power supply: Alternating Current (AC) (appears on unit only)
Potential equalization conductor terminal; used to access the warming unit’s electrical ground for electrical safety

testing (appears on unit only)

Universal Serial Bus (USB) port (for service use by qualified personnel only) (appears on unit only)

Keep dry (appears on unit and on shipping label)

Temperature limitations (shipping and storage): -40°C to +70°C (appears on shipping label only)

Temperature limitations (operating): +18°C to +28°C (appears on unit only)

Relative humidity limitations (shipping/storage): 10% to 95% (non-condensing) (appears on shipping label only)

Relative humidity limitations (operating): 15% to 85% (noncondensing) (appears on unit only)

Atmospheric pressure limitations (shipping/storage): 12 kPa to 106 kPa (appears on shipping label only)

Atmospheric pressure limitations (operating): 70 kPa to 106 kPa (appears on unit only)

CE – Conformité Européene authorization mark; 0123 – TÜV SÜD Product Service GmbH (notified body); signifies
compliance with Medical Device Directive 93/42/EEC (appears on unit and on shipping label)

CSA – Canadian Standards Association certification mark (appears on unit only)

European Community (EC) authorized representative (appears on unit and on shipping label)

Serial number (appears on unit and on shipping label)

Catalog number (appears on unit and on shipping label)

Manufacturer (appears on unit and on shipping label)

i

Date of manufacture (appears on unit and on shipping label)

Proper waste disposal for electrical and electronic equipment (WEEE) (appears on unit only)

ii

Table of Contents

1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Obtaining Technical Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Related Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

2 Product Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Product Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Operator's Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Requirements for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

3 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Safety Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Attaching the Power Cord . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Installing the Warming Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

4 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Safety Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Positioning the Warming Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Applying Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Overview of Warming Unit Operating Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Beginning Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Controlling the Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Powering Off the Warming Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Cleaning the Warming Unit after Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

5 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Cleaning the Warming Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Safety Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Filter Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Monitoring the Filter Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Component Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

6 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Safety Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Problems and Resolutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Serial Number and System Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

7 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

If an Alarm Condition Occurs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Pausing Audible Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Clearing Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Operator's Manual English 1

8 Product Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Physical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Electrical Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Performance Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Product Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Ground Integrity Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Earth Leakage Current Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Enclosure Leakage Current Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

9 Error Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Error Codes and Suggested Resolutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Figures

Figure 1. Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Figure 2. Rear View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Figure 3. Operator's Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Figure 4. Power Cord Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Figure 5. Power Cord Wrapped and Secured . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Figure 6. Rear View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Figure 7. Warming Unit Mounted on IV Pole . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Figure 8. Bed Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Figure 9. Rear View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Figure 10. Cart Mounting Peg and Warming Unit Mounting Hole . . . . . . . . . . . . . . . . . . . . 24

Figure 11. Warming Unit Mounted on Cart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Figure 12. Cart Wheel Lock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Figure 13. Modes in Operator's Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Figure 14. Main Screen at Power-On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Figure 15. Replace Filter Screen at Power-On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Figure 16. Warming System Set to 40°C (Medium) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Figure 17. Warming System Set to Boost Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Figure 18. Warming System Set to Heat Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Figure 19. Warming System Set to Ready Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Figure 20. Replace Filter Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Figure 21. Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Figure 22. Filter Information Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Figure 23. Serial Number Label on Back of Warming Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Figure 24. Menu Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Figure 25. System Information Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Figure 26. Operator's Panel (Alarm Screen) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Figure 27. Alarm Screen (Alarm Audio Paused) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Figure 28. Alarm Screen (Alarm Audio Active) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

2 Operator's Manual English

Tables

Table 1. Technical Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Table 2. Warming System Components and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Table 3. Device Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Table 4. Operating Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Table 5. Temperature Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Table 6. Warming Unit Problems and Resolutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Table 7. Alarm Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Table 8. Error Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Table 9. Alarm Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Table 10. Warming Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Table 11. Transport Cart (Optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Table 12. Electrical Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Table 13. Operating Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Table 14. Shipping and Storage Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Table 15. Performance Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Table 16. Product Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Table 17. Electromagnetic Emissions Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Table 18. Electromagnetic Immunity Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Table 19. Recommended Separation Distance Calculations . . . . . . . . . . . . . . . . . . . . . . . . . 53

Table 20. Recommended Separation Distances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Table 21. Earth Leakage Current Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Table 22. Enclosure Leakage Current Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Table 23. Error Codes and Resolutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Operator's Manual English 3

4 Operator's Manual English

1. Introduction

1.1. Overview

This manual contains information for operating the Covidien WarmTouch™ convective
warming system, which consists of the Covidien WarmTouch™ convective warming unit
and associated WarmTouch™ blankets. Before operating the warming system, thoroughly
read this manual. The latest version of this manual is available at:

www.covidien.com

1.2. Conventions

Text and terminology conventions used in this manual include the following items:

•

Warnings alert users to potential serious outcomes (death, injury, or adverse events) to
the patient, user, or environment.

•

Cautions alert users to exercise appropriate care for safe and effective use of the
product.

•

Notes provide additional guidelines or information.

1.3. Safety Information

This section lists all safety information associated with the warming unit.
Where appropriate in the manual, individual warnings and cautions are repeated as

reminders. Please familiarize yourself with this safety information before operating the
warming unit.

1

1.3.1. Warnings

•

Warning: Possible explosion hazard. Do not use the device in the presence of
flammable anesthetics or in an oxygen-rich environment.

•

Warning: Possible electric shock hazard. Grounding reliability can be achieved only
when the warming unit is connected to a suitable mains outlet with protective earth
grounding.

•

Warning: No free-hosing. Keep hose nozzle connected to a WarmTouch™ blanket at all
times or thermal injury may occur.

•

Warning: Possible burn or infection hazard. Do not allow warming blanket to come in
contact with open wounds. All patients’ wounds should be covered while using the
warming system.

•

Warning: Possible patient burns. Use caution and consider discontinuing use on
patients during vascular surgery when an artery to an extremity is clamped. Do not
apply the warming system to ischemic limbs.

•

Warning: Thermal injury may occur if the warming unit hose comes into contact with
the patient.

Operator's Manual English 5

•

Warning: Possible fire hazard. Prevent the blanket material from coming into contact
with a laser or an electrosurgical active electrode.

•

Warning: Continuously monitor the patient's temperature during treatment with the
warming system. Use good clinical judgment in selecting and adjusting temperature
settings based on the patient's warming needs and response to treatment.

•

Warning: Using the warming system on patients with transdermal medication patches
may increase the rate of drug delivery, potentially causing harm to the patient.

•

Warning: Thermally conductive materials, such as water, gel, and similar substances,
can decrease the patient's body temperature when the warming unit is switched off.

•

Warning: Do not use the warming system during magnetic resonance imaging (MRI)
scanning.

•

Warning: The use of accessories or cables with the warming system other than those
indicated in this manual may result in non-compliance with the specifications listed
in Electromagnetic Compatibility (EMC), page 50.

•

Warning: Do not operate the warming system in a stacked configuration with other
equipment.

•

Warning: Do not operate the warming system adjacent to other equipment. If such a
configuration cannot be avoided, first test the warming system in the intended
configuration to verify normal operation.

•

Warning: Use WarmTouch™ blankets only as directed. Carefully follow the instructions
for use provided with the blankets regarding proper handling and positioning.

•

Warning: WarmTouch™ blankets are for single patient use only.

•

Warning: Clean the warming unit after each use, as described in Cleaning the Warming

Unit, page 37.

•

Warning: If a fault or sudden change in performance occurs in the warming system,
discontinue use. Notify your sales/service center. The unit must be serviced by qualified
personnel using procedures provided in the service manual.

•

Warning: Possible electrical shock hazard. To reduce the risk of electrical shock, do not
remove the back case. Servicing is only to be done by qualified personnel.

•

Warning: No modification of this equipment is allowed.

1.3.2. Cautions

•

Caution: Federal (U.S.A.) law restricts the use of the warming system to sale by or on
the order of a physician.

•

Caution: Only use WarmTouch™ blankets with the WarmTouch™ warming unit. Do not
attempt to use other types of blankets with the warming unit. Similarly, do not attempt
to use WarmTouch™ blankets with other types of warming units.

•

Caution: Do not spray, pour, or spill any liquid on the warming unit, its accessories,
connectors, switches, or openings in the case.

6 Operator's Manual English

•

Caution: The HEPA filter must be replaced every 2,000 hours of operation or 365 days,
whichever comes first. Filter replacement must be performed by qualified personnel.
Refer to the service manual for replacement instructions.

•

Caution: Operation of the warming system may affect or be affected by other devices
in the vicinity due to electromagnetic interference (EMI). If interference occurs, try
increasing the distance between devices, repositioning the cabling, or plugging the
devices into separate outlet circuit branches. See Electromagnetic Compatibility (EMC),

page 50 for additional guidance.

•

Caution: The USB port on the warming unit is for service use by qualified personnel
only. During patient treatment, a USB cable must not be connected to the warming
unit.

•

Caution: The institution should follow local governing ordinances and recycling
instructions regarding disposal or recycling of filter and device components or end of
life of the product.

1.4. Obtaining Technical Assistance

For technical assistance or to order parts and additional manuals, contact Covidien
Technical Services or a local Covidien representative.

1

When contacting Covidien for troubleshooting or service issues, please provide the
information described in Serial Number and System Information, page 42.

Table 1. Technical Services

Covidien Argentina
Aguero 351
Capital Federal - 1171 ABC
Argentina
Tel: [phone]
Fax: [phone]

Covidien Austria GmbH
Campus21
Europaring F09402
Brunn am Gebrige
A-2345 Österreich
Tel: (+43) 2236 - 3788 39
Fax: (+43) 2236 - 3788 3940

Covidien Canada
19600 Clark Graham
Baie d'Urfe, QC, H9X 3R8
Canada
Tel:[phone], Ext.4004
Fax: [phone]

Covidien Asia
Singapore Regional Service Centre
15 Pioneer Hub, #06-04
Singapore 627753
Tel [phone]
Fax [phone]

Covidien Belgie S.A.-N.V.
Generaal De Wittelaan 9/5
Mechelen
2800
België
Tel [phone]
Fax [phone]

Covidien Chile
Camino lo Boza (Ex 8395)
Pudehuel
Santiago
Chile
Tel: (562) 739 - 3000
Fax: (562) 783 - 3149

Covidien Australia
52A Huntingwood Drive
Huntingwood, NSW 2148
Australia
Tel: (+61) 1800 - 350702
Fax: (+61) 2967 - 18118

Covidien Brazil
Av. Das Nações Undias 12995
Andar 23 - Brooklin
São Paulo, SP
Brasil 04578-000
Tel: [phone]
Fax: [phone]

Covidien China
2F, Tyco Plaza
99 Tian Zhou Rd
Shang Hai 200233
P.R. China
Tel: [phone]
Fax: [phone]

Operator's Manual English 7

Table 1. Technical Services (continued)

Covidien Colombia
Edificio Prados de la Morea
Carretera Central Del Norte
(Cra 7a) Kilometro 18,
Chia-Cundinamarca
Bogota, Colombia
Tel: [phone]
Fax: [phone]

Covidien Danmark A/S
Langebrogade 6E, 4. sal
1411 København K
Danmark
Tel [phone]
Fax [phone]

Covidien Finland Oy
Läkkisepäntie 23
00620 Helsinki
Finland
Te. [phone]
Fax [phone]

Covidien Hungary
1095 Budapest
Mariassy u. 7
Magyarorszag
Hungary
Tel + 36 1880 7975
Fax + 36 1777 4932

Covidien Israel
5 Shacham St.
North Industrial Park
Caesarea
38900 Israel
Tel [phone]
Fax [phone]

Covidien Korea
5F, Hibrand Living Gwan, #215,
Yangjae-Dong,
Seocho-Gu
Seoul, Korea
Tel: [phone]
Fax: [phone]

Covidien Norge AS
Postboks 343
1372 Asker.
Norway
Tel [phone]
Fax [phone]

Covidien Costa Rica
Global Park, Parkway 50
La Aurora de Heredia
Costa Rica
Tel: [phone] - 5386
Fax: [phone] - 5319

Covidien Deutschland GmbH
Technisches Service Center
Raffineriestr. 18
93333 Neustadt / Donau
Germany
Tel + 49 944 595 93 80
Fax + 49 944 595 93 65

Covidien France SA
Parc d'affaires Technopolis
Bat. Sigma, 3 Avenue du Canada
LP 851 Les Ulis
91975 Courtaboeuf Cedex
France
Tel [phone]
Fax [phone]

Covidien India
10th Floor Building No 9B
DLF Cyber City Phase III Gurgaon
Haryana - 122002
India
Tel + 91 1244 709800
Fax + 91 1244 206850

Covidien Italia S.p.A.
Via Rivoltana 2/D
20090 Segrate
Italy
Tel [phone]
Fax [phone]

Covidien Mexico
Insurgentes Sur # 863, Piso 16
Col. Nápoles
Del. Benito Juarez
Mexico, D.F. 03810 Mexico
Tel: [phone]
Fax: [phone]

Covidien Panama
Parque Industrial Costa del Esta
Calle Primera, Edificio # 109
Panama City, Panama
Tel: [phone]
Fax: [phone]

Covidien ECE
Prosecká 851/64
190 00 Praha 9
Česká republika
Tel: [phone]
Fax: [phone]

Covidien ECE
Galvaniho 7/a
821 04 Bratislava
Slovakia
Tel.: [phone]
Fax: [phone]

Covidien Hong Kong
Unit 12 - 16, 18/F
BEA Tower
Millennium City 5
4187 Kwun Tong Road
Kwun Tong, Kowloon, Hong Kong
Tel + 852 3157 7299
Fax + 852 2838 0749

Covidien Ireland
Block G, Ground Floor,
Cherrywood Technology Park,
Loughlinstown
County Dublin, Ireland
Tel [phone]
Fax [phone]

Covidien Japan Inc.
Technical Support Center
83-1, Takashimadaira 1-Chome
Itabashi-ku, Tokyo 175-0082
Japan
Tel: [phone]
Fax: [phone]

Covidien Nederland BV
Hogeweg 105
5301 LL Zaltbommel
Nederland
Tel [phone]

Covidien Polska
Al. Jerozolimskie 162
Warszawa. 02-342
Polska
Tel [phone]
Fax [phone]

8 Operator's Manual English

Table 1. Technical Services (continued)

Covidien Portugal Lda.
Estrada do Outeiro de Polima,
Lote 10-1° Abóboda
2785-521 S.Domingos de Rana
Portugal
Tel [phone]
Fax [phone]

Covidien Saglik A.S.
Maslak Mahallesi Bilim Sokak
No: 5, Sun Plaza Kat: 2-3
Sisli, Istanbul 34398
Turkey
Tel [phone]
Fax [phone]

Covidien Sverige AB
Box 54
171 74 Solna
Sweden
Tel [phone]
Fax + 46 858 56 05 29

Covidien UK
Unit 2, Talisman Business Park
London Road, Bicester
OX26 6HR, United Kingdom
Tel [phone]
Fax [phone]

Covidien Puerto Rico
Palmas Industrial Park
Road 869 Km 2.0 Bldg. #1
Cataño, PR 00962
Tel. [phone]
Ext. 7222 and 7221
Fax [phone]

Covidien South Africa
Corporate Park North
379 Roan Crescent
Randjespark
Midrand, South Africa
Tel [phone]
Fax [phone]

Covidien Switzerland
Roosstrasse 53
8832 Wollerau
Schweiz
Tel [phone]
Fax [phone]

Covidien US
15 Hampshire Street
Mansfield, MA 02048 USA
Tel [phone]
Tel [phone] (toll)

Covidien Russia
53 bld. 5 Dubininskaya Street
Moscow
Russia. 119054
Tel [phone]
Fax [phone]

Covidien Spain S.L.
Business Park World Trade Center
Almeda Park Edificio
7 - 3ª planta Plaça de la Pau s/n
Cornellà de Llobregat

Covidien Thailand
99 Soi Rubia,
Sukhumvit 42 Road
13 - 14 Fl., Berli Jucker Building
Prakanong, Klongtoey
Bangkok 10110, Thailand
Tel [phone] - 100
Fax +662 657 - 6325

1

1.5. Related Documents

•

Instructions for Use - Covidien WarmTouch™ Warming Blanket — This document,
provided with WarmTouch™ warming blankets, contains important information
regarding intended use, handling, connection, and positioning of the blanket.

•

Service Manual - Covidien WarmTouch™ Convective Warming Unit — This document,
for use by qualified personnel only, contains instructions for servicing, testing,
updating, and maintaining the warming unit. The service manual also includes
schematics, a parts list, and shipping instructions for factory service.

1.6. Warranty Information

To obtain warranty information, contact Covidien Technical Services or a local Covidien
representative. See Obtaining Technical Assistance, page 7.

Operator's Manual English 9

10 Operator's Manual English

2. Product Overview

2.1. Overview

This chapter provides an introduction to the Covidien WarmTouch™ convective warming
system, including information about its features, accessories, controls, and requirements
for use.

2.2. Product Description

The warming system provides a means for treating or preventing hypothermia in adult and
pediatric patients in clinical settings. The warming system consists of an electronic blower
(warming unit) that delivers heated air through a flexible hose to a lightweight blanket
placed on the patient. The blanket distributes the heated air through numerous small
perforations that allow the air to reach the targeted areas of the patient’s body.

2.2.1. Features

•

Multiple temperature settings—A range of temperature settings allows the clinician to
customize and adjust treatment based on the patient’s needs.

2

•

Boost mode—For rapid warming, air is generated at 47°C for 45 minutes, after which
the temperature automatically drops to the 45°C (High) temperature setting.

•

HEPA filter—A High Efficiency Particulate Air (HEPA) filter removes at least 99.97% of
particles 0.3 micrometers or larger from the air delivered to the warming blanket. The
warming unit monitors the amount of time the filter is in use and indicates when the
filter needs to be replaced.

•

Automatic over- and under-temperature protection—At any of the heated air settings,
if the temperature of the generated air is out of range for a specific amount of time, the
heater and fan automatically shut off and an alarm is issued.

•

Optional cart with wheel locks—An optional transport cart, equipped with wheel locks,
is available for the warming unit. The wheel locks reduce cart movement while the
system is in use.

2.2.2. Intended Use

The WarmTouch Convective Warming System (warming unit and blanket) is intended for
prevention and treatment of hypothermia, and for the management of appropriate
normothermia.

2.2.3. Contraindications

None known.

2.2.4. Components and Accessories

To order components and accessories, contact Covidien Technical Services or a local
Covidien representative. See Obtaining Technical Assistance, page 7.

Operator's Manual English 11

Table 2. Warming System Components and Accessories

Item Description

Covidien WarmTouch™ Convective Warming Unit Electronic blower that delivers heated air to the warming blanket.

Covidien WarmTouch™ warming blankets Warming blankets designed for exclusive use with the warming

unit. Available for a variety of treatment applications.

HEPA filter Replaceable air filter for the warming unit.

Power cord Detachable power cord for the warming unit. Type depends on

country of use.

Transport cart (optional) Optional wheeled cart for mounting the warming unit.

2.2.5. Covidien WarmTouch™ Warming Blankets

The Covidien WarmTouch™ Convective Warming Unit is designed for use with
WarmTouch™ blankets only. WarmTouch™ blankets are designed to attach securely to the
warming unit’s hose nozzle. The nozzle features guides and a clip to ensure correct
orientation.

Do not attempt to use other types of blankets with the warming unit; the performance of
the warming system has not been evaluated with other blankets and cannot be predicted.

The warming unit is compatible with all WarmTouch™ blankets.
Consult the Instructions for Use provided with the warming blankets for important

information regarding proper handling and application.

12 Operator's Manual English

2.3. Product Views

2.3.1. Front View

Figure 1. Front View

2

1. Operator's panel

2. Handle

3. No free-hosing label

4. Hose

5. Nozzle strap with clip

6. Nozzle

Operator's Manual English 13

2.3.2. Rear View

Figure 2. Rear View

1. No free-hosing label

2. Serial number label

3. Symbols label

4. USB port (under cover) – for service
use by qualified personnel only

2.4. Operator's Panel

The operator’s panel includes an On/Standby key, a multi-functional keypad, and a display
that provides temperature and status information. The display indicates the function of
each adjacent key.

Note: Key functions change based on operating context, such as when accessing system
information (see Chapter 6), or when an alarm condition is present (see Chapter 7).

14 Operator's Manual English

5. Mounting channel (×2)

6. Blower clamp (×3)

7. Bed hook

8. Power cord

Figure 3. Operator's Panel

1. On/Standby Key—Press to place the warming unit in Ready mode or to return to
Standby mode. See Beginning Treatment, page 30 and Returning to Standby

Mode, page 34.

2. Status LED—Indicates the warming unit’s operational status. See Overview of

Warming Unit Operating Modes, page 29.

2

3. Fan Off Key—During operation, press to turn off the fan. The heater, if running,
shuts off automatically. See Returning to Ready Mode, page 34.

4. Temperature and Information Area—Displays the current air temperature being
generated (rounded to the closest 1°C).

5. Menu Key—Press to access screens for viewing filter status and system information.
See Monitoring the Filter Status, page 38 and Serial Number and System

Information, page 42.

6. 47°C (Boost Mode) Key—Press to generate air at 47°C (116.6°F) for 45 minutes.
See Using Boost Mode, page 33.

7. 45°C (High) Key—Press to generate air at 45°C (113°F). See Controlling the

Temperature, page 32.

8. 40°C (Medium) Key—Press to generate air at 40°C (104°F). See Controlling the

Temperature, page 32.

9. 34°C (Low) Key—Press to generate air at 34°C (93.2°F). See Controlling the

Temperature, page 32.

10. Heat Off Key—Press to deliver air at room temperature (unheated). See Controlling

the Temperature, page 32.

Table 3. Device Symbols

Symbol Description

On/standby

Fan off

Menu

Operator's Manual English 15

Symbol Description

47°C (Boost Mode)

45°C (High)

40°C (Medium)

34°C (Low)

Heat off

Dashes instead of a temperature reading indicate that the warming unit is in Ready mode (both
heater and fan are off)

Animated symbol indicates that the fan is on.

Animated symbol indicates that the heater is on.

Animated arrow indicates that the temperature is adjusting upward or downward to a new set‐
ting (disappears when the temperature is within 1.5°C of the new setting)

Audio paused symbol (appears on the operator's panel when an alarm is active to denote the
key for pausing audible alarm tones; the symbol color is reversed on the screen while alarm
tones are paused)

Table 3. Device Symbols (continued)

Note: The Menu icon is shown in Figure 3 for reference only; it is accessible only when the
heater and fan are off (Ready mode).

Note: When pressing any of the temperature setting keys, the Heat Off key, or the Fan Off
key, the setting is highlighted on the display to indicate the current selection. For example,
in Figure 3, 34° is the current selection.

Note: A soft click tone indicates a successful key press.

2.5. Requirements for Use

2.5.1. Clinician Prerequisites

The warming system is intended for use by licensed healthcare practitioners or clinical
personnel knowledgeable in its proper operation. Before using the warming system, be
sure to familiarize yourself with the information provided in this manual and in the
instructions for use provided with the warming blankets.

2.5.2. Treatment Environment

•

Warning: Possible explosion hazard. Do not use the device in the presence of
flammable anesthetics or in an oxygen-rich environment.

•

Warning: Do not use the warming system during magnetic resonance imaging (MRI)
scanning.

•

Warning: Do not operate the warming system in a stacked configuration with other
equipment.

16 Operator's Manual English

•

Warning: Do not operate the warming system adjacent to other equipment. If such a
configuration cannot be avoided, first test the warming system in the intended
configuration to verify normal operation.

•

Warning: Clean the warming unit after each use, as described in Cleaning the Warming

Unit, page 37.

•

Caution: Do not spray, pour, or spill any liquid on the warming unit, its accessories,
connectors, switches, or openings in the case.

•

Caution: Operation of the warming system may affect or be affected by other devices
in the vicinity due to electromagnetic interference (EMI). If interference occurs, try
increasing the distance between devices, repositioning the cabling, or plugging the
devices into separate outlet circuit branches. See Electromagnetic Compatibility (EMC),

page 50 for additional guidance.

The warming system is intended for use only in hospitals and hospital-type facilities.
Typical locations of use include the operating room, the operative holding area, the post
anesthesia care unit (PACU), and other care areas. The warming system is not intended for
home use.

Proper operation of the warming system requires the following conditions:

•

Ambient temperature: 18°C to 28°C (64.4°F to 82.4°F)

2

•

Relative humidity: 15% to 85% (non-condensing)

2.5.3. Warming Blanket Use

•

Warning: No free-hosing. Keep hose nozzle connected to a WarmTouch™ blanket at all
times or thermal injury may occur.

•

Warning: Possible fire hazard. Prevent the blanket material from coming into contact
with a laser or an electrosurgical active electrode.

•

Warning: Use WarmTouch™ blankets only as directed. Carefully follow the instructions
for use provided with the blankets regarding proper handling and positioning.

•

Warning: WarmTouch™ blankets are for single patient use only.

•

Caution: Only use WarmTouch™ blankets with the WarmTouch™ warming unit. Do not
attempt to use other types of blankets with the warming unit. Similarly, do not attempt
to use WarmTouch™ blankets with other types of warming units.

2.5.4. Patient Considerations

•

Warning: Possible burn or infection hazard. Do not allow warming blanket to come in
contact with open wounds. All patients’ wounds should be covered while using the
warming system.

•

Warning: Possible patient burns. Use caution and consider discontinuing use on
patients during vascular surgery when an artery to an extremity is clamped. Do not
apply the warming system to ischemic limbs.

•

Warning: Thermal injury may occur if the warming unit hose comes into contact with
the patient.

Operator's Manual English 17