WarmTouch WT-5800 Operator’s Manual Rev B Jan 2004

Contents Contents ... i Figures... ii Tables... iii Safety Information ... 1

Warnings ... 1 Cautions ... 2 Introduction... 3

Intended Use ... 3 Manual Availability ... 3 Background Information... 3 Safety Features... 4 Customized Warming Therapy... 4 Automatic Temperature Stepdown ... 4 Automatic Over Temperature Shutdown... 4 Warning Light... 4 HEPA Filter ... 4 Wheel Locks ... 4 Symbols ... 6 The Warming System Description... 6 Installation ... 9

Cart Installation... 9 IV Pole Installation ... 10 Patient Bed Installation... 11 Using the Warming System ... 13

Power Supply Cord ... 13 Main Power... 13 Temperature Control... 14 Air Filter ... 15 Self Supporting Air Hose... 15 Using WarmTouch CareQuilt and CareDrape Blankets... 15 Routine Maintenance... 17

Cleaning the Warming System ... 17 Other Routine Maintenance ... 17 Specifications ... 19

Warming System Specifications ... 19 Transport and Shipping in Shipping Container ... 20 Compliance ... 20 Manufacturer’s Declaration ... 22 Principles of Operation ... 27

Control Panel ... 27 Index... 29

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Contents

Figures Figure 1: Figure 2: Figure 3: Figure 4: Figure 5: Figure 6: Figure 7: Figure 8: Figure 9: Figure 10: Figure 11:

ii

Cart Wheel Lock ... 5 Model 5800 Front View ... 7 Model 5800 Back View ... 8 Warming System Cart Installation ... 9 Warming System IV Pole Installation ... 10 Warming System Patient Bed Installation ... 11 Main Power Switch ... 13 Ambient Temperature Light ... 14 Control Panel ... 14 Control Panel ... 27 Warning Light ... 27

Contents

Ta b l e s Table 1: Table 2: Table 3: Table 4: Table 5: Table 6: Table 7: Table 8:

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5800 Symbols 6 Model 5800 Blower Specifications 19 Model 5800 Cart Specifications 19 Model WT-5800 Compliance 20 Electromagnetic Emissions 22 Electromagnetic Immunity 23 Electromagnetic Immunity, RF Portable Equipment... 25 Recommended Separation Distances 26

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Safety Information

Warnings WARNING: Possible Explosion Hazard. Do not use the WarmTouch® Model 5800 Patient Warming System in the presence of flammable anesthetic agents.

WARNING: Possible Electrical Shock Hazard. Do not open or disassemble the warming system. If a malfunction occurs, please notify your sales/service center.

WARNING: Possible Electric Shock Hazard. Grounding reliability can be achieved only when the warming system is connected to a suitable mains outlet.

WARNING: Possible Fire Hazard. Prevent the blanket material from coming into contact with a laser or an electrosurgical active electrode; rapid combustion could result.

WARNING: Possible Burn Hazard. Do not apply heat directly to 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. This could possibly cause the patient to be burned.

WARNING: Possible Patient Burns. Use caution and monitor closely if used on patients with severe peripheral vascular disease. This could possibly cause the patient to be burned.

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Safety Information

WARNING: Possible Patient Burns. Do not warm patients with the warming system hose only. Thermal injury may result. Always attach the hose to a WarmTouch blanket before providing warming therapy.

WARNING: WarmTouch, CareDrape®, and CareQuilt® blankets are for single patient use only.

WARNING: MRI Scanning. The warming system is not suitable for use during magnetic resonance imaging (MRI) scanning. The warming system may affect the MRI image.

WARNING: Continuously monitor the patient's temperature. Reduce the air temperature or discontinue therapy when normothermia is reached.

Cautions Caution: The warming system is fitted with an air filter; however, airborne contamination should be considered when using the warming system. Caution: If the warming system is mounted on the intravenous (IV) pole, it should be installed with the top of the unit’s handle less than 76 cm (30 inches) above the floor to prevent the IV pole from tipping over. Caution: The warming system should not be operated in the presence of electromagnetic fields that are greater than 3 volts/meter. This could cause shutdown of the warming system by the fail-safe function within the equipment. Caution: If a malfunction occurs in the warming system, discontinue use. Notify your sales/service center of the malfunction. The unit must be serviced by an authorized service technician. Caution: Ensure that the patient is dry or the warming system may be ineffective.

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Introduction

Intended Use The WarmTouch Model 5800 Patient Warming System (warming unit and blanket) is intended for prevention and treatment of hypothermia, for example, with the surgical patient, the patient in the pre-operative area, the pregnant woman who shivers during epidual anesthesia due to hypothermia, or any patient who is uncomfortable anywhere in the cold critical care environment.

Manual Availability The most recent revision of this manual is available on the Internet at: http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/ProductManuals.html

Background Information There are numerous ways of warming your patient, from cotton blankets to water mattresses. Research has shown that low temperatures surrounding the patient are a major factor contributing to hypothermia.1), 2) The warming system covers the patient with warm air and actively transfers heat across the skin. The result is to achieve normal thermia. In creating this warm customized pocket of air around the hypothermic patient, it is important to note that stagnant air, even if it is warm, does not work as an effective heat transfer medium. Stagnant air acts as an insulator, preventing the boundary layer of molecules next to the skin surface from transferring heat. Forced air warming causes warmed air molecules to flow over cooler skin surface. It is this active flow of warmed molecules that acts as a heat transfer medium. With the warming system, air is warmed and delivered into a lightweight blanket (CareQuilt or CareDrape Blanket) that rests over or under the patient. The CareQuilt and CareDrape blankets have many small perforations on the underside that allow air to exit the blanket and surround the patient.

1) Morris RH, Wilkey BR. "The Effects of the Ambient Temperature on Patient Temperature During Surgery Not Involving Body Cavities.” Anesthesiology 32:102-107, 1970. 2) Morris RH. “Influence of Ambient Temperature on Patient Temperature During Intraabdominal Surgery.” Annals of Surgery 173:230-233, 1971.

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Introduction

Safety Features The warming system is designed to give healthcare professionals more control over the patient’s core body temperature. There are several safety features of the warming system which make it safe and appropriate for such use.

Customized Warming Therapy Clinicians select temperature range setting at the onset of warming therapy to help ensure the appropriate setting is selected for every patient.

Automatic Temperature Stepdown The warming system provides a 45-minute temperature stepdown feature. When in the high mode, air temperature will automatically drop to medium after each 45 minutes of continuous use. The temperature may be reset to high mode by selecting high temperature on the unit front panel to start another 45-minute cycle.

Automatic Over Temperature Shutdown The automatic temperature controller and two back-up systems help to ensure temperature will not reach excessive levels. If necessary, the back-up systems automatically turn off the heater and illuminates the warning light. The warming system heater will start producing heat when the warming system temperature drops to approximately 35 ºC.

Warning Light When the warning light on the control panel is illuminated, it indicates that one of the two thermostats has turned off the heater. The reason for the heater turn-off should be investigated as soon as possible after use.

HEPA Filter The system's high efficiency particulate air filter is 99.97% efficient at 0.3 micron particle size.

Wheel Locks The cart is equipped with two wheel locks. The wheel locks prevent the cart from moving while in use. The wheel locks must be released when moving the cart.

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Introduction

Press the wheel lock arm down to lock the wheel. Lift the wheel lock arm to release the wheel lock. See Figure 1.

1 - Wheel Lock Figure 1: Cart Wheel Lock

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Introduction

Symbols The symbols identified in Table 1 are the symbols used on the 5800 and all 5800 labeling. Table 1: 5800 Symbols Attention symbol, consult accompanying documentation Temperature Control Ambient Air

Temperature Control Low (30-34 °C)

Temperature Control Medium (36-40 °C)

Temperature Control High (42-46 °C)

Mains I Power On 0 Power Off Protection Class I Protection Type BF

The Warming System Description The WarmTouch Model 5800 Patient Warming System (warming unit and blanket) is intended for prevention and treatment of hypothermia, for example, with the surgical patient, the patient in the pre-operative area, the pregnant woman who shivers during epidual anesthesia due to hypothermia, or any patient who is uncomfortable anywhere in the cold critical care environment. See Figure 2, Model 5800 Front View and Figure 3, Model 5800 Back View.

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Introduction

1 - Hose

4 - Power Cord

2 - Main Power Switch

5 - Hour Meter

3 - Nozzle

6 - Control Panel Figure 2: Model 5800 Front View

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Introduction

1 - Over-Temperature Test Port

4 - Warning Label

2 - Bed Hook Bracket

5 - Nozzle Strap with Clip

3 - Filter Cover

6 - Instruction Label

Figure 3: Model 5800 Back View

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Installation

Cart Installation The warming system is shipped installed on the warming system cart. See Figure 4. The warming system should not be placed on the cart with the handle any higher than 61.6 cm (24.25 inches). At this height, the warming system and cart pass the required 10-degree tilt test. Ensure that the three blower cart clamps are tight.

1 - 61.6 centimeters (24.25 inches) (Maximum) 2 - Blower cart clamps Figure 4: Warming System Cart Installation

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Installation

IV Pole Installation Figure 5 illustrates the installation of the warming system on an IV pole. The warming system should not be installed on the IV pole with the handle higher than 76 centimeters (30 inches).

1 - 76 centimeters (30 inches) (Maximum)

Figure 5: Warming System IV Pole Installation

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Installation

Patient Bed Installation Figure 6 illustrates the installation of the warming system on a patient bed. The patient rail connectors will fit on bed rails up to 1.4 inches (3.6 centimeters) wide.

1 - Bed Rails

Figure 6: Warming System Patient Bed Installation

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U s i n g t h e Wa r m i n g S y s t e m

Power Supply Cord Plug the warming system power cord into a suitable mains outlet.

Main Power Power is controlled through one main rocker switch located on the front of the warming system. To begin operation, press the switch to the ON position (Figure 7). The ambient (room temperature) light on the control panel will illuminate and the unit will begin to blow air. See Figure 8. WARNING: No free-hosing. Do not use the blower without a blanket. Applying heat to a patient directly from the blower hose may cause patient burns.

1 - Main Power Switch

Figure 7: Main Power Switch

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Using the Warming System

1 - Ambient Temperature Light

Figure 8: Ambient Temperature Light

Temperature Control The heating temperature is controlled through the panel of buttons. This panel has four temperature settings: •

Ambient... Ambient Air (room temperature)

•

Low... 30 °C-34 °C (86 °F - 93 °F)

•

Medium ... 36 °C-40 °C (97 °F - 104 °F)

•

High... 42 °C-46 °C (108 °F - 115 °F)

The temperature settings represent the range of air temperature entering the blanket. For patients with severe hypothermia requiring rapid warming, select High. To help prevent hypothermia or for treatment of mild hypothermia, select Medium or Low. The selected temperature light will illuminate. See Figure 9.

Figure 9: Control Panel WARNING: The patient must be closely monitored for rewarming vasodilation and possible hypotension. Use good judgment when selecting a temperature. If unsure of proper setting, consult with the attending physician.

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Using the Warming System

Air Filter The warming system contains a HEPA filter rated 99.97% efficient at 0.3 micron particle size. See Routine Maintenance on page 17 for filter replacement procedure.

Self Supporting Air Hose Air is delivered into the CareQuilt or CareDrape blankets through a wire reinforced hose, attached to the warming system.

Using WarmTouch CareQuilt and CareDrape Blankets WarmTouch, CareQuilt and CareDrape blankets come in a range of sizes and configurations to fit patients' individual sizes, surgical procedures, and comfort needs. Follow the instructions provided with all WarmTouch blankets for specific information concerning their recommended use.

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