WarmTouch WT-5900 Operator’s Manual Rev A June 2007

Contents 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 Over-Temperature Alarm ...5 Wheel Locks ...5 Symbols ...6 Description of the Warming System ...7 Installation ... 9

Cart Installation ...9 IV Pole Installation ...10 Patient Bed Installation ...10 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 ...21 Principles of Operation ... 27

Control Panel ...27 Index ... 29

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Contents

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

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Cart Wheel Lock ... 5 Model WT-5900 Front View ... 7 Model WT-5900 Back View ... 8 Warming System Cart Installation ... 9 Warming System IV Pole Installation ... 10 Warming System Patient Bed Installation ... 11 Main Power Switch ... 13 Low Temperature Light ... 14 Control Panel ... 14 Control Panel ... 27

Contents

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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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WT-5900 Symbols ... 6 Model WT-5900 Blower Specifications ... 19 Model WT-5900 Cart Specifications ... 19 Model WT-5900 Compliance ... 20 Electromagnetic Emissions ... 21 Electromagnetic Immunity ... 21 Electromagnetic Immunity, RF Portable Equipment ... 24 Recommended Separation Distances ... 25

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Safety Information

Warnings WARNING: Possible explosion hazard. Do not use the WarmTouch® Model WT-5900 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 patient’s 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.

WARNING: Hose nozzle must be connected to a WarmTouch blanket or thermal injury may occur.

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Safety Information

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: 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: The Model WT-5900 should not be operated in the presence of electromagnetic fields that are greater than 3 Volts/meter. This could cause shutdown of the Model WT-5900 by the fail-safe function within the equipment. Caution: Ensure that the patient is dry or the warming system may be ineffective.

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Introduction

Intended Use The WarmTouch Model WT-5900 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 holding area, the pregnant woman who shivers during epidural 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 Boost mode, blower temperature will automatically drop to the high mode after each 45- minutes of use. The temperature may be reset to the Boost mode by selecting the Boost 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, illuminates the warning light and sounds an alarm. The warming system heater will start producing heat when the warming system temperature drops to approximately 34 ºC to 37 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.

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Introduction

Over-Temperature Alarm An over-temperature alarm will sound when automatic over temperature shutdown occurs. The over-temperature alarm will continue to sound while the unit is in an over temperature shutdown condition.

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

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Figure 1: Cart Wheel Lock

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Introduction

Symbols The symbols identified in Table 1 are the symbols used on the WT-5900 and all WT-5900 labeling. Table 1: WT-5900 Symbols Attention symbol, consult accompanying documentation Temperature Control Low (32 °C) Temperature Control Medium (38 °C) Temperature Control High (43 °C)

Temperature Control Boost (45 °C for 45 minutes)

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

Do not direct air from the hose to the patient (free-hosing); use hose only with warming blankets.

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Introduction

Description of the Warming System The WarmTouch Model WT-5900 Patient warming system (Figure 2 and Figure 3), CareQuilt and CareDrape blankets are intended for prevention and treatment of hypothermia, for example, with the surgical patient, the patient in the preoperative holding 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.

1 - Hose

4 - Power Cord

2 - Main Power Switch

5 - Hour Meter

3 - Nozzle

6 - Control Panel Figure 2: Model WT-5900 Front View

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1 6

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5

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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 WT-5900 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.

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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 installed on an IV pole. The warming system should not be installed on the IV pole with the handle higher than 76 centimeters (30 inches).

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1 - 76 centimeters (30 inches) (Maximum) Figure 5: Warming System IV Pole 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 3.6 centimeters (1.4 inches) wide.

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Installation

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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 Main Power switch to the ON position (Figure 7). The Low temperature light on the control panel will illuminate and the unit will begin to blow air in the low temperature mode. See Figure 8. WARNING: Hose nozzle must be connected to a WarmTouch blanket or thermal injury may occur.

1 Main Power Switch Figure 7: Main Power Switch

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