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)

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

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

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.

1.3.1. 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.

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: (5411) 4863-5300 Fax: (5411) 4863-4142

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:1-514-695-1220, Ext.4004 Fax: 1-514-695-4965

Covidien Asia Singapore Regional Service Centre 15 Pioneer Hub, #06-04 Singapore 627753 Tel (65) 6578 5288 Fax (65) 6515 5260

Covidien Belgie S.A.-N.V. Generaal De Wittelaan 9/5 Mechelen 2800 België Tel +32 152 981 37 Fax +32 152 167 83

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: (5511) 2187-6200 Fax: (5511) 2187-6380

Covidien China 2F, Tyco Plaza 99 Tian Zhou Rd Shang Hai 200233 P.R. China Tel: (+86) 4008 1886 86 Fax: (+86) 2154 4511 18

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: (571) 619-5469 Fax: (571) 619-5425

Covidien Danmark A/S Langebrogade 6E, 4. sal 1411 København K Danmark Tel +45 702 753 50 Fax +45 702 756 50

Covidien Finland Oy Läkkisepäntie 23 00620 Helsinki Finland Te. +35 896 226 84 10 Fax +35 896 226 84 11

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 +97 246 277 388 Fax +97 266 277 688

Covidien Korea 5F, Hibrand Living Gwan, #215, Yangjae-Dong, Seocho-Gu Seoul, Korea Tel: +822 570 5459 Fax: +822 570 5499

Covidien Norge AS Postboks 343 1372 Asker. Norway Tel +47 668 522 22 Fax +47 668 522 23

Covidien Costa Rica Global Park, Parkway 50 La Aurora de Heredia Costa Rica Tel: (506) 2239 - 5386 Fax: (506) 2239 - 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 +33 169 821 416 Fax +33 169 821 532

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 +39 027 030 81 31 Fax +39 027 031 72 84

Covidien Mexico Insurgentes Sur # 863, Piso 16 Col. Nápoles Del. Benito Juarez Mexico, D.F. 03810 Mexico Tel: (5255) 5804-1524 Fax: (5255) 5536-1326

Covidien Panama Parque Industrial Costa del Esta Calle Primera, Edificio # 109 Panama City, Panama Tel: (507) 264-7337 Fax: (507) 236-7408

Covidien ECE Prosecká 851/64 190 00 Praha 9 Česká republika Tel: +420 239 000 711 Fax: +420 239 000 437

Covidien ECE Galvaniho 7/a 821 04 Bratislava Slovakia Tel.: +421 248 214 573 Fax: +421 248 214 501

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 +353 1 4381613 Fax 353 1 439 3039

Covidien Japan Inc. Technical Support Center 83-1, Takashimadaira 1-Chome Itabashi-ku, Tokyo 175-0082 Japan Tel: +81 (0) 3 6859 0120 Fax: +81 (0) 3 6859 0142

Covidien Nederland BV Hogeweg 105 5301 LL Zaltbommel Nederland Tel +31 41 857 66 00

Covidien Polska Al. Jerozolimskie 162 Warszawa. 02-342 Polska Tel +48 223 122 130 Fax +48 223 122 020

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 +35 121 448 10 36 /30 Fax +35 121 445 1082

Covidien Saglik A.S. Maslak Mahallesi Bilim Sokak No: 5, Sun Plaza Kat: 2-3 Sisli, Istanbul 34398 Turkey Tel +90 212 366 20 00 Fax +90 212 276 35 25

Covidien Sverige AB Box 54 171 74 Solna Sweden Tel +46 858 56 05 00 Fax + 46 858 56 05 29

Covidien UK Unit 2, Talisman Business Park London Road, Bicester OX26 6HR, United Kingdom Tel +44(0)1869 328092 Fax +44(0)1869 327585

Covidien Puerto Rico Palmas Industrial Park Road 869 Km 2.0 Bldg. #1 Cataño, PR 00962 Tel. 787-993-7250 Ext. 7222 and 7221 Fax 787-993-7234

Covidien South Africa Corporate Park North 379 Roan Crescent Randjespark Midrand, South Africa Tel +27 115 429 500 Fax +27 115 429 624

Covidien Switzerland Roosstrasse 53 8832 Wollerau Schweiz Tel +41 44786 5050 Fax +41 44786 5010

Covidien US 15 Hampshire Street Mansfield, MA 02048 USA Tel 1.800.635.5267 Tel 1.925.463.4635 (toll)

Covidien Russia 53 bld. 5 Dubininskaya Street Moscow Russia. 119054 Tel +70 495 933 64 69 Fax +70 495 933 64 68

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 +662 2073 - 100 Fax +662 657 - 6325

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.

•

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

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.

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

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: 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.

•

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)

•

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.

•

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

Operator's Manual English 17

•

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.

18 Operator's Manual English

3. Installation

3.1. Overview

This chapter contains information for installing the Covidien WarmTouch™ convective warming unit.

3.2. Safety Reminders

Warning: No modification of this equipment is allowed.

3.3. Attaching the Power Cord

The warming unit is shipped with a power cord appropriate to the country of use. To attach the power cord:

1. Position the warming unit on its front so the bottom of the unit is accessible.

2. Connect the power cord’s female connector to the socket in the warming unit, making sure the connector is fully inserted.

Figure 4. Power Cord Connection

1. Power cord female connector

3. Press the power cord into the routing bracket until it is fully seated.

2. Routing bracket

Operator's Manual English 19

4. Set the warming unit upright. Wrap the power cord around the back of the unit, and secure it with the provided strap. See Figure 5.

Figure 5. Power Cord Wrapped and Secured

3.4. Installing the Warming Unit

The warming unit can be used as a standalone device, or it can be mounted on an IV pole, bed, or optional transport cart. The following sections provide mounting instructions.

3.4.1. IV Pole Installation

The warming unit can be mounted on an IV pole with a maximum diameter of 3.2 cm (1.25 inches) and a minimum diameter of 1.9 cm (0.75 inches).

To avoid tipping, the warming unit must be mounted on the pole with the handle no higher than 76 cm (30 inches) above the floor.

Tools Required: Measuring tape To install the warming unit on an IV pole:

1. On the IV pole, mark the maximum mounting height. The warming unit’s handle must be no higher than 76 cm (30 inches) above the floor.

20 Operator's Manual English

2. Ensure that the power cord is secured at the back of the warming unit. See Figure 5.

3. Locate the mounting channel with two clamps at the back of the warming unit. Do not use the mounting channel with one clamp. See Figure 6.

4. Loosen the knobs on the two clamps and rotate the clamp feet away from the mounting channel.

Figure 6. Rear View

1. Mounting channel

2. Clamp foot (×2)

5. Bracing the IV pole, position the warming unit against the pole so that the pole is fully seated in the mounting channel. Verify that the handle is not above the maximum height. See Figure 7.

6. Rotate the two clamp feet across the IV pole, and tighten the clamp knobs to secure the warming unit. Do not overtighten.

3. Clamp knob (×2)

Operator's Manual English 21

Figure 7. Warming Unit Mounted on IV Pole

3.4.2. Bed Installation

The warming unit can be attached to a bed that has a mounting surface up to 3.6 cm (1.4 inches) wide. Typically, the unit is attached to the bed’s head board or foot board.

Tools Required: None To attach the warming unit to a bed:

1. Locate the bed hook on the back of the warming unit. See Figure 2, page 14. The hook slides in and out to accommodate different mounting surface widths.

2. Hang the bed hook over the mounting surface to attach the warming unit to the bed.

22 Operator's Manual English

Figure 8. Bed Installation

3.4.3. Cart Installation

An optional transport cart is available for the warming unit. Contact Covidien Technical Services or a local Covidien representative to purchase the transport cart. See Obtaining

Technical Assistance, page 7.

Tools Required: None To install the warming unit on the cart:

1. Ensure that the power cord is secured at the back of the warming unit. See Figure 9.

2. Loosen the knobs on the three clamps at the back of the warming unit, and rotate the clamp feet away from the mounting channels.

Operator's Manual English 23

Figure 9. Rear View

1. Mounting channel (×2)

3. Clamp foot (×3)

2. Clamp knob (×3)

3. Locate the mounting pegs on the cart’s vertical poles, and locate the holes at the bottom of the warming unit’s mounting channels.

Figure 10. Cart Mounting Peg and Warming Unit Mounting Hole

1. Mounting channel (×2)

2. Mounting hole (×2)

24 Operator's Manual English

3. Mounting peg (×2)

4. Holding the warming unit by the handle and bracing the cart, position the warming unit against the cart so that the mounting holes engage the mounting pegs. The cart poles must be fully seated in the mounting channels.

5. Rotate each of the three clamp feet across the cart poles, and tighten the clamp knobs to secure the warming unit. Do not overtighten.

Figure 11. Warming Unit Mounted on Cart

Operator's Manual English 25

26 Operator's Manual English

4. Operation

4.1. Overview

This chapter provides instructions for operating the Covidien WarmTouch™ convective warming unit. Use these instructions in conjunction with the instructions for use provided with WarmTouch™ warming blankets.

4.2. Safety Reminders

•

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

Unit, page 37.

•

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

•

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.

4.3. Positioning the Warming Unit

•

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

•

As described in Chapter 3, the warming unit may be mounted on a cart, IV pole, or bed. Alternatively, the warming unit can be placed on the floor (under the operating table, for example). Whichever method is used, be sure to consider the following when positioning the warming unit for operation:

Operator's Manual English 27

•

Power outlet access and power cord position—Ensure that the power outlet used for the warming unit is easily accessible; disconnection from the outlet is the only way to completely remove power from the warming unit.

•

Air intake clearance—Ensure that the air intake at the back of the warming unit is not obstructed. Do not cover any part of the warming unit.

•

Front panel access and visibility—Ensure that the operator can easily access the warming unit’s front panel controls and view the display during treatment.

•

Hose position—Determine where the warming unit hose will be connected to the blanket. Ensure that the hose does not impede access to the patient, warming unit controls, or other equipment. To secure the hose, use the clip attached to the nozzle strap (see Figure 1, page 13).

•

Sterility—Certain WarmTouch™ blankets intended for surgical applications are sterile when used according to their instructions, while the warming unit and hose are not sterile. Check the blanket before use to see if it is a sterile blanket. If the blanket is sterile, to maintain a sterile operating field, position the warming unit and hose outside the sterile field. To maintain sterility for sterile blankets, carefully follow the blanket’s instructions for use.

Prior to operation, check the warming unit, power cord, and safety labels for any damage or deterioration. If service is required, contact Covidien Technical Services or a local Covidien representative. See Obtaining Technical Assistance, page 7.

4.3.1. Using the Optional Transport Cart

If the warming unit is mounted on the optional cart, engage the two rear wheel locks to reduce cart movement during use. Press the lock arms down to lock the wheels (see Figure 12). Lift the lock arms up to move the cart.

Figure 12. Cart Wheel Lock

28 Operator's Manual English

4.4. Applying Power

•

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

•

page 50 for additional guidance.

To apply power to the warming unit:

1. Ensure that you have followed the guidelines in Positioning the Warming Unit,

page 27.

2. Plug the warming unit’s power cord into a hospital-grade or suitable mains outlet with protective earth grounding.

The status LED illuminates amber to indicate that the warming unit is in Standby mode. The fan and heater are off, and the display is blank.

4.5. Overview of Warming Unit Operating Modes

Table 4. Operating Modes

Standby mode Ready mode Treatment mode

Status LED Amber Green Green

Heater Off Off On or Off

Fan Off Off On

Display Off On On

Operator's Manual English 29

Figure 13. Modes in Operator's Screen

1. On/Standby Key—Press to place the unit in Ready mode and prepare for operation, or press to return to Standby mode when treatment is complete. See Beginning

Treatment, page 30 and Returning to Standby Mode, page 34.

2. Temperature Keys—Press to place the unit in Treatment mode, delivering air to the blanket. See Controlling the Temperature, page 32.

3. Fan Off Key—Press to return to Ready mode, pausing air delivery during treatment. See Returning to Standby Mode, page 34.

4.6. Beginning Treatment

•

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

30 Operator's Manual English

•

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

To begin treatment:

Press the On/Standby key. The unit enters Ready mode.

•

The status LED turns green, and the display turns on.

•

A short tone indicates a successful power-on self-test (POST). If POST is unsuccessful, an alarm screen appears. See If an Alarm Condition Occurs,

page 45.

•

The Main screen appears (Figure 14). Note that if the filter needs to be replaced, the Replace Filter screen appears instead of the Main screen (Figure 15).

Figure 14. Main Screen at Power-On

Figure 15. Replace Filter Screen at Power-On

2. If the Replace Filter screen appears, take the warming unit out of operation and have the filter replaced by qualified personnel (see Filter Replacement, page 38). It

Operator's Manual English 31

is possible to continue operation; however, failure to replace the filter as recommended can adversely affect device performance. If you choose to continue operation, press the OK key. The Main screen appears (Figure 14). Until the filter is replaced, the Replace Filter screen reappears at each subsequent power-on.

3. Position a WarmTouch™ warming blanket on the patient, and attach the blanket to the hose, as described in the blanket’s instructions for use. Make sure that the hose is positioned such that it does not twist the blanket inlet.

4. Proceed to Controlling the Temperature, page 32 to select a temperature setting for the patient.

4.7. Controlling the Temperature

•

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.

•

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

Select an initial setting by pressing one of the temperature keys. Continuously monitor the patient’s temperature, and adjust the setting as necessary.

Note that the temperature settings and readings on the display correspond to internal measurements of the air entering the hose. The air temperature entering the blanket is lower and can vary depending on environmental conditions. Use Table 5 as a guideline for selecting temperature settings.

Table 5. Temperature Settings

Setting Average temperature entering

hose

(Heat Off)

(Low)

(Medium)

(High)

(Boost)

Room temperature Room temperature To aid in cooling the patient,

34°C (93°F) 32°C (90°F) To help prevent or treat

40°C (104°F) 38°C (100°F)

45°C (113°F) 42°C (108°F)

47°C (117°F) for 45 minutes 44°C (111°F) To rapidly warm patients.

Average temperature entering blanket

Typical use

if necessary.

hypothermia, or to maintain appropriate normothermia.

32 Operator's Manual English

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

When changing the temperature setting, an amber arrow appears next to the current temperature while it adjusts. When the temperature is within approximately 1.5°C of the new setting, the arrow disappears.

4.7.1. Using Boost Mode

Boost mode allows rapid warming of patients. Air is generated at 47°C (116.6°F) for 45 minutes. After 45 minutes, the setting automatically changes to 45°C (High).

To use Boost mode, press the 47°C (Boost Mode) key. A countdown timer shows the time remaining before the temperature switches to the 45°C (High) setting. Boost mode sessions can be repeated as necessary.

Figure 17. Warming System Set to Boost Mode

4.7.2. Using the Heat Off Setting

If a patient requires cooling, press the Heat Off key. Air is delivered to the warming

blanket at room temperature (heater off).

Operator's Manual English 33

Figure 18. Warming System Set to Heat Off

4.7.3. Returning to Ready Mode

During operation, you can switch back to Ready mode (fan and heat off) any time you do not need to apply air to the warming blanket. The display stays on, and the unit remains ready to operate.

To return to Ready mode, press the Fan Off key. Note that in Ready mode, the

temperature reading shows dashes.

Figure 19. Warming System Set to Ready Mode

4.7.4. Returning to Standby Mode

Use Standby mode when you are finished using the warming system but do not wish to unplug it.

To return to Standby mode during operation, press the On/Standby key. The heater

and fan shut off, the display goes blank, and the status LED turns amber.

4.7.5. If Power is Interrupted

If power is interrupted during operation, the warming unit responds as follows, based on the duration of the power loss:

•

Power restored within approximately 15 seconds—The warming unit powers up, performs a power-on self-test (POST), and resumes operation in the same mode as before the power loss.

34 Operator's Manual English

•

Power restored after approximately 15 seconds—The warming unit powers up in Standby mode.

If the warming unit powers back up in Standby mode, press the On/Standby key to

enter Ready mode, then select a temperature setting to resume treatment.

4.8. Powering Off the Warming Unit

To power off the warming unit:

1. Press the On/Standby key. The fan and heater (if running at the time) turn off. The display goes blank, and the status LED turns amber.

2. To completely remove power from the warming unit, unplug the unit’s power cord from the outlet.

4.9. Cleaning the Warming Unit after Operation

Warning: Clean the warming unit after each use, as described in this manual. See Cleaning

the Warming Unit, page 37.

To reduce the risk of patient or operator infection, clean the warming unit after each use.

Operator's Manual English 35

36 Operator's Manual English

5. Maintenance

5.1. Overview

This chapter describes the cleaning and maintenance requirements for the Covidien WarmTouch™ convective warming unit.

5.2. Cleaning the Warming Unit

Warning: Clean the warming unit after each use, as described in this manual. Caution: Do not spray, pour, or spill any liquid on the warming unit, its accessories,

connectors, switches, or openings in the case. For surface cleaning and disinfection of the warming unit, follow your institution's

procedures or the recommended actions below:

•

Surface cleaning—Use a soft cloth dampened with either a commercial, nonabrasive cleaner or a solution of 70% alcohol in water, lightly wiping the surfaces of the warming unit.

•

Disinfection—Use a soft cloth saturated with a solution of 10% chlorine bleach in tap water, lightly wiping the surfaces of the warming unit.

5.3. Safety Checks

5.3.1. Physical Inspection

Covidien recommends a visual check of the following items before each use of the warming unit:

•

Equipment—Inspect the warming unit and power cord for mechanical damage or deterioration.

•

Labels—Inspect the safety labels for legibility.

Do not use a damaged unit. If service is required, contact Covidien Technical Services or a local Covidien representative. See Obtaining Technical Assistance, page 7.

5.3.2. Alarm and Temperature Verification

Once a year, qualified personnel must perform tests to verify the alarm system and the heater’s output temperatures. Instructions are provided in the service manual. Covidien recommends performing these tests each time the filter is replaced and any time the unit requires repair.

5.3.3. Electrical Safety Tests

Electrical safety tests must be performed by qualified personnel after specific types of service. Consult the service manual for requirements and instructions.

Operator's Manual English 37

5.4. Filter Replacement

If the filter needs to be replaced, the screen shown in Figure 20 appears at power-on. Remove the warming unit from operation until the filter can be replaced by qualified personnel. Failure to replace the filter as recommended can adversely affect device performance.

Figure 20. Replace Filter Screen

5.5. Monitoring the Filter Status

The warming unit monitors filter usage and provides counters that indicate the number of operating hours and days until the filter needs to be replaced. Anticipate filter replacement by checking the counters on the Filter Information screen.

Note: The Filter Information screen is only accessible when the warming unit is in Ready mode. It is not accessible while the warming unit is operating.

To view the Filter Information screen:

1. If the warming unit is not already powered on, follow the steps in Applying Power,

page 29.

3. Press the Menu key on the Main screen. The Menu screen appears.

Press the On/Standby key to enter Ready mode.

38 Operator's Manual English

Figure 21. Menu Screen

4. Press the Filter Information key. The Filter Information screen indicates the days and operating hours remaining before the filter needs to be replaced.

Figure 22. Filter Information Screen

1. Filter Days Remaining 2. Filter Hours Remaining

5. To return to the Main screen, press the Exit key twice.

Note: The Menu screen and Filter Information screen shown in Figure 21 and Figure 22 provide access to service functions used by qualified personnel only. These functions require input of a key code. Press the Exit key to return to the prior screen after inadvertently pressing either of these keys:

System Test key

Filter Reset key

5.6. Component Disposal

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.

Instructions for the proper disposal of used warming blankets are provided in the blanket’s instructions for use.

Air filter replacement and disposal must be performed by qualified personnel. Instructions for the proper disposal of used filters are provided in the service manual.

Operator's Manual English 39

The warming unit must be disposed of in accordance with WEEE Directive and

national laws and regulations. Do not dispose of this product as unsorted municipal waste.

40 Operator's Manual English

6. Troubleshooting

6.1. Overview

This chapter describes how to troubleshoot problems that may occur while using the Covidien WarmTouch™ convective warming unit.

6.2. Safety Reminders

•

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.

•

page 50 for additional guidance.

6.3. Problems and Resolutions

Table 6. Warming Unit Problems and Resolutions

Problem Resolution

Failure to power on Check the power cord’s connection to the warming unit. The connector

must be fully seated. See Attaching the Power Cord, page 19. If the power cord is properly connected, an internal component may have

failed. Notify qualified personnel to service the warming unit.

Electromagnetic interference between the warming unit and other devices

Filter needs to be replaced Remove the warming unit from operation and have the filter replaced by

Low-priority alarm Power the warming unit off and back on to clear the alarm.

Software error Power the warming unit off and back on to clear the error.

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 guid‐ ance.

qualified personnel. See Filter Replacement, page 38. Failure to replace the filter as recommended can adversely affect device

performance.

See If an Alarm Condition Occurs, page 45 for additional information.

See Chapter 9 for additional information.

Operator's Manual English 41

6.4. Serial Number and System Information

If needing to contact Covidien Technical Services for assistance, please provide the warming unit’s serial number and, if possible, the software version number and any error messages displayed.

6.4.1. Serial Number

The serial number is located on the back of the warming unit.

Figure 23. Serial Number Label on Back of Warming Unit

6.4.2. System Information

The software version number and recent error codes (generated when alarms or system errors occur) can be obtained from the warming unit’s System Information screen.

Note: The System Information screen is only accessible when the warming unit is in Ready mode. It is not accessible while the warming unit is operating.

To access the System Information screen:

1. If the warming unit is not already powered on, follow the steps in Applying Power,

page 29.

3. Press the Menu key. The Menu screen appears.

42 Operator's Manual English

Press the On/Standby key to enter Ready mode.

Figure 24. Menu Screen

4. Press the System Information key. The System Information Screen shows the software version and the most recent error messages, if any.

Note: Time stamps associated with error messages do not necessarily reflect local time. The warming unit is set to GMT at manufacture.

Figure 25. System Information Screen

1. Software version

5. To return to the Main screen, press the Exit key twice.

Note: The screen shown in Figure 25 is illustrative. Version information is specific to the unit.

For a list of error codes and related information, see Error Codes and Suggested

Resolutions, page 57.

2. Error messages (up to six)

6.4.3. Error and Event Log

The warming unit maintains a log of errors and events to assist qualified personnel in troubleshooting.

Log entries are maintained through power cycles or when power is removed from the unit. When the log file reaches capacity, entries are erased to make room for new entries, with the oldest entry erased first.

Instructions for accessing the log are provided in the service manual.

Operator's Manual English 43

44 Operator's Manual English

7. Alarms

7.1. Overview

This chapter describes how to deal with alarms while using the Covidien WarmTouch™ convective warming unit.

7.2. If an Alarm Condition Occurs

If an alarm condition or error occurs during operation, the heater and the fan both turn off. The warming unit sounds alarm tones and shows the alarm screen.

Figure 26. Operator's Panel (Alarm Screen)

1. Alarm symbol

2. Alarm message

4. Audio paused key

5. On/standby key

3. Remedy message

Table 7. Alarm Indicators

Symbol Tones Type of alarm

Two successive tones repeating Low-priority alarm: A condition that requires operator awareness, but

does not pose a risk of harm to the patient. All WarmTouch™ WT-6000 alarms are classified as low-priority alarms.

See Pausing Audible Alarms, page 46 for instructions for pausing audible alarm tones for up to 2 minutes.

See Clearing Alarms, page 47 for instructions for clearing an alarm. If clearing an alarm is unsuccessful, remove the unit from service until it can be repaired by qualified personnel.

Note: If multiple alarms are active at the same time, the unit shows messages for all active alarms in a repeating cycle.

Operator's Manual English 45

Table 8. Error Indicators

Symbol Tones Type of error

None Software error: An error occurring in the unit software outside of

patient use. See Clearing Alarms, page 47 for instructions for clearing the error. If

clearing the error is unsuccessful, remove the unit from service until it can be repaired by qualified personnel.

Table 9. Alarm Conditions

Alarm message Likely cause Resolution

Blanket Overheat The measured air temperature has exceeded

48° C for at least 30 seconds.

Fan Error The fan speed was detected as too fast (>5000

RPM) or too slow (<3000 RPM) to reliably main‐ tain the selected temperature.

The fan experienced a hardware-based failure.

No Heat Delivered The selected temperature has not been

reached within 10 minutes of selecting it in the main screen.

System Error A software or hardware error was detected

during operation.

Temp Error The measured air temperature is above or

below the selected target temperature, or can‐ not be reliably measured.

Power down the unit, then restart. If the condition persists, replace the unit.

7.3. Pausing Audible Alarms

When an alarm is active, the unit offers the ability to pause audible alarm tones for 2 minutes.

To pause an audible alarm:

1. Press the audio paused key. The audio paused symbol changes color, and a countdown timer appears showing the remaining time that the alarm tones are paused.

Figure 27. Alarm Screen (Alarm Audio Paused)

When the audio paused period ends, the countdown timer disappears, the audio paused symbol returns to normal, and the alarm tones resume.

46 Operator's Manual English

Figure 28. Alarm Screen (Alarm Audio Active)

2. If needed, press the audio paused key again to pause the audible alarm for an additional 2 minutes.

7.4. Clearing Alarms

To clear a low-priority alarm:

If the alarm does not clear, remove the warming unit from operation until it can be repaired by qualified personnel.

Note: If an alarm condition resolves on its own without operator intervention, visible and audible alarm indicators will cease and the main screen will appear, without requiring the unit to be powered down.

Power off the warming unit by pressing the key indicated on the alarm screen.

Press the On/Standby key to power on the warming unit.

Operator's Manual English 47

48 Operator's Manual English

8. Product Specifications

8.1. Overview

This chapter provides physical and operational specifications for the Covidien WarmTouch™ convective warming unit.

8.2. Physical Characteristics

Table 10. Warming Unit

Weight with power cord 5.2 kg (11.5 pounds)

Dimensions - hose fully collapsed, nozzle in storage position on unit 60 cm x 43 cm x 30 cm

Power cord length 4.3 m (14 feet)

Table 11. Transport Cart (Optional)

Weight 3.1 kg (6.8 pounds)

Height 67.1 cm (26.4 inches)

Width 32.3 cm (12.7 inches)

Depth 38.6 cm (15.2 inches)

(24 inches x 17 inches x 12 inches)

8.3. Electrical Requirements

Table 12. Electrical Requirements

Power requirements 100 to 240 V AC

Max. current at 100 V = 8 A Max. current at 240 V = 5 A

Input frequency 50/60 Hz ±1 Hz

Fuse (×2) Littlefuse (mfr.) 0218010; 250 V, 10 A

8.4. Environmental Specifications

Table 13. Operating Specifications

Temperature 18°C to 28°C (64.4°F to 82.4°F)

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

Table 14. Shipping and Storage Specifications

Temperature -40ºC to 70ºC (-40ºF to 158ºF)

Relative humidity 10% to 95% (non-condensing)

Atmospheric pressure 12 kPa to 106 kPa (90 mmHg to 795 mmHg)

Note: Before operating the warming unit after it has been shipped or stored, allow the unit to acclimate to the operating environment for at least 60 minutes.

Operator's Manual English 49

8.5. Performance Specifications

Table 15. Performance Specifications

Maximum contact surface temperature 44.1°C (111.4°F)

Average time for contact surface temperature to rise from 23°C ±2°C to 37°C

Average time for temperature of air exiting the hose to rise from 23°C ±2°C to 37°C

Accuracy of displayed temperature ±1.0°C (air entering hose)

Automatic temperature stepdown (Boost to High temperature) After 45 minutes of continuous use, blower will

Thermal protection threshold Thermostat (internal):

Average alarm level 56 dB @ 1 meter

6 minutes

<1 minute

step down from Boost to High setting

49°C to 55°C (120°F to 131°F)

8.6. Product Compliance

Table 16. Product Compliance

Equipment classification IEC 60601-1:2005 + A1:2012, EN 60601-1:2006 + A12:2014

ANSI/AAMI ES60601-1:2005(R)2012 EN 60601-1-8:2007 + A11:2017 CAN/CSA C22.2 No 60601-1:14 IEC 80601-2-35:2009 + A1:2016 EN 80601-2-35:2009 + A1:2016

Protection type Class I

Degree of protection Type BF - Applied part

Mode of operation Continuous

Electromagnetic compatibility IEC 60601-1-2:2014, EN 60601-1-2:2015, Class A Emissions

IEC/EN 80601-2-35:2009 + A1:2016

Protection against ingress of fluids Ordinary

8.7. Electromagnetic Compatibility (EMC)

8.7.1. Manufacturer’s Declaration

The warming system is suitable for prescription use only in the specified electromagnetic environments. Use the warming system in accordance with the electromagnetic environments described in the following sections.

50 Operator's Manual English

8.7.2. Electromagnetic Emissions

Table 17. Electromagnetic Emissions Guidelines

Guidance and manufacturer’s declaration—electromagnetic emissions (IEC 60601-1-2:2014, EN 60601-1-2:2015, Table 1)

The warming system is intended for use in the electromagnetic environment specified below. The customer or the user

of the warming system should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment guidance

RF emission CISPR 11

Harmonic emission IEC/EN 61000-3-2

Voltage fluctua‐ tion/flicker emissions

IEC/EN 61000-3-3

Caution: The warming system is not intended for use in residential environments and may not provide adequate protection to radio communication services in such environments.

Group 1, Class A This is a class A product per IEC CISPR 11 and is not

intended to be used in a residential environment. If used in a domestic environment, this equipment may not offer adequate protection to radio-frequency communication services. The user may be required to take mitigation measures, such as relocating or re-ori‐ enting the equipment.

Class A The warming system is suitable for use in all establish‐

ments other than domestic and those directly con‐

Complies

nected to the public low-voltage power network that supplies buildings used for domestic purposes.

8.7.3. Electromagnetic Immunity

Table 18. Electromagnetic Immunity Guidelines

Guidance and manufacturer’s declaration—electromagnetic immunity (IEC 60601-1-2:2014, EN 60601-1-2:2015, Table 2)

The warming system is intended for use in the electromagnetic environment specified below. The customer or the user

of the warming system should assure that it is used in such an environment.

Immunity test IEC/EN 60601-1-2 test

Electrostatic discharge (ESD)

IEC/EN 61000-4-2

Electric fast transi‐ ent/burst

IEC/EN 61000-4-4

Surge IEC/EN 61000-4-5

Voltage dips, short inter‐ ruptions and voltage var‐ iations on power supply

IEC/EN 61000-4-11

±6 kV contact ±8 kV air

±2 kV for power supply lines

±1 kV input/output lines

±1 kV line(s) to line(s) ±2 kV line(s) to earth

<5% UT (>95% dip in UT) for 0.5 cycle

40% UT (60% dip in UT) for 5 cycles

70% UT (30% dip in UT) for 25 cycles

<5% UT (>95% dip in UT) for 5 seconds

level

Compliance level Electromagnetic environment guidance

±6 kV contact ±8 kV air

±2 kV for power supply lines

±1 kV input/output lines

±1 kV line(s) to line(s) ±2 kV line(s) to earth

<5% UT (>95% dip in UT) for 0.5 cycle

40% UT (60% dip in UT) for 5 cycles

70% UT (30% dip in UT) for 25 cycles

<5% UT (>95% dip in UT) for 5 seconds

Floors should be wood, concrete, or ceramic tile. If floors are covered with syn‐ thetic material, the relative humidity should be at least 30%.

Mains power quality should be that of a typical commercial or hospital environ‐ ment.

If the user of the warming system requires continued operation during power mains interruption, it is recommended that the warming system be powered from an uninterruptible power supply or battery.

Operator's Manual English 51

Table 18. Electromagnetic Immunity Guidelines (continued)

Guidance and manufacturer’s declaration—electromagnetic immunity (IEC 60601-1-2:2014, EN 60601-1-2:2015, Table 2)

The warming system is intended for use in the electromagnetic environment specified below. The customer or the user

of the warming system should assure that it is used in such an environment.

Immunity test IEC/EN 60601-1-2 test

level

Power frequency (50/60 Hz) magnetic field

IEC/EN 61000-4-8

Note: UT is the AC main’s voltage prior to application of the test level.

3 A/m 3 A/m Power frequency magnetic fields should

Compliance level Electromagnetic environment guidance

be at levels characteristic of a typical loca‐ tion in a typical commercial or hospital environment.

52 Operator's Manual English

Table 19. Recommended Separation Distance Calculations

Guidance and manufacturer’s declaration—electromagnetic immunity (IEC 60601-1-2:2014, EN 60601-1-2:2015, Table 4)

The warming system is intended for use in the electromagnetic environment specified below. The customer or the user

of the warming system should assure that it is used in such an environment.

Immunity test IEC/EN 60601-1-2 test

level

Conducted RF

IEC/EN 61000-4-6

Radiated RF

IEC/EN 61000-4-3

3 Vrms

150 kHz

80 MHz

3 V/m

80 MHz

800 MHz

3 V/m

800 MHz

2.5 GHz

Compliance level Electromagnetic environment guidance

3 Vrms

150 kHz

80 MHz

3 V/m

80 MHz

800 MHz

3 V/m

800 MHz

2.5 GHz

Portable and mobile RF communications equip‐ ment should be used no closer to any part of the warming system, including cables, than the rec‐ ommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended Separation Distance

d = 1.2 √P

150 kHz to 80 MHz

d = 1.2 √P

80 MHz to 800 MHz

d = 2.3 √P

800 MHz to 2.5 GHz

where P is the maximum output power rating of

the transmitter in watts (W) according to the

transmitter manufacturer and d is the recom‐

mended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a , should be less than the compliance level in each

frequency range b.

Interference may occur in the vicinity of equip‐

ment marked with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and

reflection from structures, objects, and people.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the warming system is used exceeds the applicable RF compliance level above, the warming system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the warming system.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Operator's Manual English 53

Table 20. Recommended Separation Distances

Recommended separation distances between portable and mobile RF communications equipment and the warming

system (IEC 60601-1-2:2014, EN 60601-1-2:2015, Table 7)

The warming system is intended for use in an electromagnetic environment in which radiated RF disturbances are con‐ trolled. The customer or the user of the warming system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the warming sys‐

tem as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output

power (P) of transmitter in

watts

0.01 0.12 0.12 0.23

0.10 0.38 0.38 0.73

1.00 1.20 1.20 2.30

10.00 3.80 3.80 7.30

100.00 12.00 12.00 23.00

For transmitters rated at a maximum output power not listed above, estimate the separation distance (d) using the equation in the corresponding column, where P is the maximum output [power rating of the transmitter in watts (W)] according to the transmitter manufacturer.

Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and

reflection from structures, objects and people.

150 kHz to 80 MHz

d = 1.2 √P

Separation distance in meters

80 MHz to 800 MHz

d = 1.2 √P

800 MHz to 2.7 GHz

d = 2.3 √P

8.8. Ground Integrity Test

Without power cord: ≤100 mΩ With power cord: ≤200 mΩ

8.9. Earth Leakage Current Test

Table 21. Earth Leakage Current Test

AC polarity Line cord Neutral cord Leakage current

Normal Closed Closed 300 μA

Reversed Closed Closed 300 μA

Normal Open Closed 1000 μA

Normal Closed Open 1000 μA

8.10. Enclosure Leakage Current Test

Table 22. Enclosure Leakage Current Test

AC line cord Neutral line cord Power line ground cable AAMI / ANSI Standard ES1

Normal Closed Closed 100 μA

Normal Closed Open 500 μA

Normal Open Closed 500 μA

Reversed Closed Closed 100 μA

54 Operator's Manual English

Table 22. Enclosure Leakage Current Test (continued)

AC line cord Neutral line cord Power line ground cable AAMI / ANSI Standard ES1

Reversed Open Closed 500 μA

Reversed Closed Open 500 μA

Operator's Manual English 55

56 Operator's Manual English

9. Error Codes

9.1. Overview

This chapter defines the error codes that may be generated during operation of the WarmTouch™ convective warming unit.

Warming unit alarms and system errors (hardware-related or software-related) generate specific error codes. View the most recent error codes on the System Information screen, as shown in System Information, page 42. Service personnel can also access the unit's error and event log if needed.

Suggested resolutions are provided for each error. If an error situation cannot be resolved, or if you see an error code that is not listed, contact Covidien Technical Services. See Obtaining Technical Assistance, page 7.

9.2. Error Codes and Suggested Resolutions

9.2.1. Error Categories

Warming unit errors are divided into three categories:

•

A/D—Errors associated with or reported by the A/D microprocessor.

•

POST—Errors occurring during power-on self-test.

•

UI—Errors associated with or reported by the UI microprocessor.

9.2.2. Error Code and Resolution List

Table 23. Error Codes and Resolutions

003

Category: A/D

Description: Checksum error on code in flash. A/D flash is defective.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

004

Category: A/D

Description: One of the following conditions occurred:

•

Temperature was more than ±1°C from the setpoint for at least 30 consecutive seconds after the set‐ point was reached.

•

Temperature did not reach the specified setpoint within 10 minutes.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

005

Category: A/D

Description: Temperature >48°C for at least 30 consecutive seconds.

Operator's Manual English 57

Table 23. Error Codes and Resolutions (continued)

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

006

Category: A/D

Description: Thermal cut-out switch has opened.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

011

Category: A/D

Description: Thermistor temperature too low to measure.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

012

Category: A/D

Description: Thermistor temperature too high to measure.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

013

Category: A/D

Description: Fan motor drew too much current.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

014

Category: A/D

Description: Fan speed <3000 rpm.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

015

Category: A/D

Description: Fan speed > 5000 rpm.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

016

Category: A/D

Description: Fan speed too low for current fan voltage.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

017

Category: A/D

Description: Fan speed too high for current fan voltage

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

028

58 Operator's Manual English

Table 23. Error Codes and Resolutions (continued)

Category: A/D

Description: Flash erase error during software upgrade.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

029

Category: A/D

Description: Flash write error during software upgrade.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

030

Category: A/D

Description: Flash verify error during software upgrade.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

031

Category: A/D

Description: Invalid flash state (software error) during software upgrade.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

032

Category: A/D

Description: Checksum error on downloaded software during software upgrade.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

033

Category: A/D

Description: Timeout on A/D SW update data message during software upgrade.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

038

Category: A/D

Description: Too many consecutive CRC errors in SPI commands.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

045

Category: A/D

Description: Thermistor open circuit.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

046

Category: A/D

Description: Thermistor shorted.

Operator's Manual English 59

Table 23. Error Codes and Resolutions (continued)

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

048

Category: A/D

Description: Fan voltage >48.1 V (or >10 V when turned off).

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

049

Category: A/D

Description: Fan voltage <10 V.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

051

Category: A/D

Description: Thermistor values not changing.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

053

Category: A/D

Description: No edges detected on AC_STATUS signal.

Resolution: N/A (indicates that the power cord was disconnected while the unit was still powered on).

131

Category: POST

Description: RAM check error during POST.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

132

Category: POST

Description: Clock frequency error during POST.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

133

Category: POST

Description: Keypad error during unit power-on self test (POST). Typically, this occurs when the user presses a key while

POST is running.

Resolution: If this error occurs without a key being pressed during POST, turn power off to the warming unit, then turn

power back on. If the error persists, remove the unit from use for servicing by qualified personnel.

138

Category: POST

Description: Flash write/read test failed during POST.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

60 Operator's Manual English

Table 23. Error Codes and Resolutions (continued)

140

Category: POST

Description: RTC NVRAM write/read test failed during POST.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

144

Category: POST

Description: UI calculated checkword does not match the stored checkword.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

145

Category: POST

Description: GPX calculated checkword does not match the stored checkword.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

152

Category: UI

Description: External watchdog timed out.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

157

Category: UI

Description: Thermostat open.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

158

Category: UI

Description: One of the following conditions occurred:

•

Temperature was more than ±1°C from the setpoint for at least 30 consecutive seconds after the set‐ point was reached.

•

Temperature did not reach the specified setpoint within 10 minutes.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

159

Category: UI

Description: Temperature >48°C for at least 30 consecutive seconds.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

163

Category: UI

Description: Bad CRC on packet received from AD microprocessor.

Operator's Manual English 61

Table 23. Error Codes and Resolutions (continued)

Resolution: This error may appear due to electromagnetic interference from other devices. 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.

Turn power off to the warming unit, then turn power back on. If the error persists, remove the unit from use for servicing by qualified personnel.

165

Category: UI

Description: No communication from A/D microprocessor.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

175

Category: UI

Description: Software upgrade cannot proceed due to checkword check error. Software file may be corrupted.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

176

Category: UI

Description: Software upgrade cannot proceed due to header check error. Software file may be corrupted or invalid.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

177

Category: UI

Description: The UI microprocessor received a message from the A/D microprocessor indicating that the heater and fan

were shut down. Cause is typically provided in subsequent error messages.

Resolution: N/A (refer to subsequent error messages)

178

Category: UI

Description: The UI microprocessor received a message from the A/D microprocessor indicating that the fan was shut

down. Cause is typically provided in subsequent error messages.

Resolution: N/A (refer to subsequent error messages)

179

Category: UI

Description: The UI microprocessor received a message from the A/D microprocessor indicating that the heater was

shut down. Cause is typically provided in subsequent error messages.

Resolution: N/A (refer to subsequent error messages)

181

Category: UI

Description: Corrupt data in the RTC section of the RTC chip.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

182

Category: UI

Description: Unable to communicate with the RTC chip.

62 Operator's Manual English

Table 23. Error Codes and Resolutions (continued)

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

184

Category: UI

Description: RTC NVRAM contained an illegal setpoint temperature.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

186

Category: UI

Description: Error communicating with A/D microprocessor across SPI bus.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

202

Category: UI

Description: UI microprocessor is receiving too many interrupts from the A/D microprocessor.

Resolution: This error may appear due to electromagnetic interference from other devices. 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.

Turn power off to the warming unit, then turn power back on. If the error persists, remove the unit from use for servicing by qualified personnel.

204

Category: UI

Description: Spurious interrupt from A/D microprocessor.

Resolution: This error may appear due to electromagnetic interference from other devices. 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.

Turn power off to the warming unit, then turn power back on. If the error persists, remove the unit from use for servicing by qualified personnel.

205

Category: UI

Description: Bad checksum or other failure during file download for software upgrade.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

207

Category: UI

Description: The length of the UI code image downloaded to external flash is too small.

Resolution: Turn power off to the warming unit, then turn power back on.

If the error persists, remove the unit from use for servicing by qualified personnel.

211

Category: UI

Description: The UI and A/D microprocessors disagree as to the temperature setpoint.

Operator's Manual English 63

Table 23. Error Codes and Resolutions (continued)

Resolution: This error may appear due to electromagnetic interference from other devices. 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.

Turn power off to the warming unit, then turn power back on. If the error persists, remove the unit from use for servicing by qualified personnel.

213

Category: UI

Description: Read error from RTC.

Resolution: This error may appear due to electromagnetic interference from other devices. 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.

Turn power off to the warming unit, then turn power back on. If the error persists, remove the unit from use for servicing by qualified personnel.

214

Category: UI

Description: Write error to RTC.

Resolution: This error may appear due to electromagnetic interference from other devices. 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.

Turn power off to the warming unit, then turn power back on. If the error persists, remove the unit from use for servicing by qualified personnel.

215

Category: UI

Description: Unspecified RTC error.

Resolution: This error may appear due to electromagnetic interference from other devices. 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.

Turn power off to the warming unit, then turn power back on. If the error persists, remove the unit from use for servicing by qualified personnel.

64 Operator's Manual English

Covidien llc,

15 Hampshire Street, Mansfield, MA 02048 USA

Covidien Ireland Limited IDA Business and Technology Park, Tullamore, Ireland. www.covidien.com 1 800 635 5267 [T]

Medtronic 5016000 Operator's Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Symbols

Table of Contents

Figures

Tables

1. Introduction

1.1. Overview

1.2. Conventions

1.3. Safety Information

1.3.1. Warnings

1.3.2. Cautions

1.4. Obtaining Technical Assistance

1.5. Related Documents

1.6. Warranty Information

2. Product Overview

2.1. Overview

2.2. Product Description

2.2.1. Features

2.2.2. Intended Use

2.2.3. Contraindications

2.2.4. Components and Accessories

2.2.5. Covidien WarmTouch™ Warming Blankets

2.3. Product Views

2.3.1. Front View

2.3.2. Rear View

2.4. Operator's Panel

2.5. Requirements for Use

2.5.1. Clinician Prerequisites

2.5.2. Treatment Environment

2.5.3. Warming Blanket Use

2.5.4. Patient Considerations

3. Installation

3.1. Overview

3.2. Safety Reminders

3.3. Attaching the Power Cord

3.4. Installing the Warming Unit

3.4.1. IV Pole Installation

3.4.2. Bed Installation

3.4.3. Cart Installation

4. Operation

4.1. Overview

4.2. Safety Reminders

4.3. Positioning the Warming Unit

4.3.1. Using the Optional Transport Cart

4.4. Applying Power

4.5. Overview of Warming Unit Operating Modes

4.6. Beginning Treatment

4.7. Controlling the Temperature

4.7.1. Using Boost Mode

4.7.2. Using the Heat Off Setting

4.7.3. Returning to Ready Mode

4.7.4. Returning to Standby Mode

4.7.5. If Power is Interrupted

4.8. Powering Off the Warming Unit

4.9. Cleaning the Warming Unit after Operation

5. Maintenance

5.1. Overview

5.2. Cleaning the Warming Unit

5.3. Safety Checks

5.3.1. Physical Inspection

5.3.2. Alarm and Temperature Verification

5.3.3. Electrical Safety Tests

5.4. Filter Replacement

5.5. Monitoring the Filter Status

5.6. Component Disposal

6. Troubleshooting

6.1. Overview

6.2. Safety Reminders

6.3. Problems and Resolutions

6.4. Serial Number and System Information

6.4.1. Serial Number

6.4.2. System Information

6.4.3. Error and Event Log

7. Alarms

7.1. Overview

7.2. If an Alarm Condition Occurs

7.3. Pausing Audible Alarms