Operator’s Manual
38 Pages
Preview
Page 1
To obtain information about a warranty, if any, contact Covidien Technical Services at 1.800.635.5267 or your local representative. Purchase of this instrument confers no express or implied license under any Covidien patent to use the instrument with any patient warming system that is not manufactured or licensed by Covidien.
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Table of Contents Safety Information 1-1 1.1 Overview... 1-1 1.2 Safety Information... 1-1 1.2.1 Warnings... 1-2 1.2.2 Cautions... 1-4 Introduction 2.1 2.2 2.3 2.4 2.5
2.6 2.7
2-1 Overview... 2-1 Intended Use... 2-1 Manual Availability... 2-1 Background Information... 2-1 Safety Features... 2-2 2.5.1 Customized Warming Therapy... 2-2 2.5.2 Automatic Temperature Stepdown... 2-2 2.5.3 Automatic Over Temperature Shutdown... 2-2 2.5.4 Alarms... 2-2 2.5.5 HEPA Filter... 2-3 2.5.6 Wheel Locks... 2-3 Symbols... 2-4 Description of the Warming System... 2-6
Installation 3.1 3.2 3.3 3.4
3-1 Overview... 3-1 Cart Installation... 3-2 IV Pole Installation... 3-3 Patient Bed Installation... 3-4
Using the Warming System 4-1 4.1 Overview... 4-1 4.2 Power Supply Cord... 4-1 4.3 Main Power... 4-1 4.4 Temperature Control... 4-2 4.5 Air Filter... 4-2 4.6 Self-Supporting Air Hose... 4-3 4.7 Using WarmTouch™ Blankets... 4-3 Routine Maintenance 5-1 5.1 Overview... 5-1 5.2 Cleaning the Warming System... 5-1 5.3 Routine Maintenance... 5-1 Specifications 6.1 6.2 6.3
6-1 Overview... 6-1 Warming System Specifications... 6-2 Transport and Shipping in Shipping Container... 6-2
WarmTouch™ Model WT-5800 Patient Warming System Operator’s Manual
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6.4
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Compliance... 6-3 6.4.1 Manufacturer’s Declaration... 6-3 6.4.2 Electromagnetic Compatibility (EMC)... 6-4 6.4.2.1 Electromagnetic Emissions... 6-4 6.4.2.2 Electromagnetic Immunity... 6-5
WarmTouch™ Model WT-5800 Patient Warming System Operator’s Manual
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Safety Information
1.1
Overview This manual contains information for using the WarmTouch™ Model WT-5800 patient warming system. Before operating the warming system, thoroughly read the Operator's Manual. The latest version of this manual is available on the Internet at: http://www.respiratorysolutions.covidien.com
1.2
Safety Information This section contains safety information requiring users to exercise appropriate caution while using the warming system. Warning The WARNING symbol identifies warnings. Warnings alert the user to potential serious outcomes, such as death, injury, or adverse events to the patient or user.
Caution The CAUTION symbol identifies cautions. Cautions alert the user to exercise care necessary for the safe and effective use of the warming system. NOTE: The NOTE symbol identifies notes. Notes contain important information that may otherwise be overlooked or missed.
Safety Information
1.2.1 Warnings Warning Possible explosion hazard. Do not use the device in the presence of flammable anesthetics.
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 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.
Warning Possible patient burns. Use caution and monitor closely if used on patients with severe peripheral vascular disease.
Warning 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.
Warning No free-hosing. Keep hose nozzle connected to a WarmTouch™ blanket at all times or thermal injury may occur.
Warning WarmTouch™ blankets are for single patient use only.
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WarmTouch™ Model WT-5800 Patient Warming System Operator’s Manual
Safety Information
Warning 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.
Warning 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.
Warning The patient must be closely monitored for rewarming. Vasodilation and possible hypotension can occur. Use good judgment when selecting a temperature. If unsure of proper setting, consult with the attending physician.
Warning The use of accessories and power cables other than those specified may result in increased emission and/or decreased immunity of the warming system.
Warning Thermal injury may occur if the warming system hose comes into contact with the patient.
Warning Using the warming system on transdermal medication patches may increase the rate of drug delivery, potentially causing harm to the patient.
WarmTouch™ Model WT-5800 Patient Warming System Operator’s Manual
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Safety Information
1.2.2 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 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. Service is only to be done by qualified personnel.
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.
Caution The HEPA filter must be changed every 2,000 hours of operation. Refer to the Routine Maintenance section in the Service Manual for replacement procedures requiring a qualified technician.
Caution Do not spray, pour, or spill any liquid on the warming system, its accessories, connectors, switches, or openings in the case.
Caution Ensure the patient is dry or the warming system may be ineffective.
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WarmTouch™ Model WT-5800 Patient Warming System Operator’s Manual
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Introduction
2.1
Overview This chapter provides an introduction to the WarmTouch™ Model WT-5800 patient warming system.
2.2
Intended Use The WarmTouch™ Model WT-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 preoperative holding area, the pregnant woman who shivers during epidural anesthesia due to hypothermia, or any patient who is uncomfortable in the cold critical care environment.
2.3
Manual Availability The most recent revision of this manual is available on the Internet at: http://www.respiratorysolutions.covidien.com
2.4
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 normothermia. 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. 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 Intra-abdominal Surgery.” Annals of Surgery 173:230-233, 1971.
Introduction
With the warming system, air is warmed and delivered into a lightweight blanket that rests over or under the patient. The blankets have many small perforations on the underside that allow air to exit the blanket and surround the patient.
2.5
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.
2.5.1 Customized Warming Therapy Clinicians select a temperature range setting at the onset of warming therapy to help ensure the appropriate setting is selected for every patient.
2.5.2 Automatic Temperature Stepdown The warming system provides a 45-minute temperature stepdown feature. When using the High temperature setting, blower temperature will automatically drop to the Medium temperature setting after each 45 minutes of use. The temperature may be reset to the High temperature setting by selecting the High temperature setting on the control panel to start another 45-minute cycle.
2.5.3 Automatic Over Temperature Shutdown The automatic temperature controller and two back-up systems help ensure the temperature will not reach excessive levels. If necessary, the control system automatically turns off the heater element when the blower outlet temperature rises to between 47ºC and 50ºC, illuminates the flashing warning light, and sounds an audible alarm. The warming system heater will start producing heat when the warming system temperature drops to between approximately 34ºC and 37ºC. A yellow warning light illuminates whenever the control system identifies an over-temperature condition.
2.5.4 Alarms The WarmTouch™ control circuit manages and monitors operation of the patient warming system. Should the control circuit encounter a failure condition, it reports failures using both visual and audible alarms. The visual alarm is a yellow warning indicator on the control panel that lights at power on, upon power restoration following power failure, and whenever the control system identifies an alarm condition. The audible alarm sounds intermittently or continuously, depending on the alarm condition. In either case, investigate immediately. The WarmTouch control circuit recognizes two failure conditions. 1. Power On/Power Fail Alarm - This condition causes an intermittent audible alarm and continuous visual alarm. It appears at power on and after power failure, indicating the operator must select the desired temperature. Upon selection of a temperature key, the system cancels the alarm and the blower operates at the desired temperature. 2. Over-temperature Alarm - This condition causes a continuous audible alarm and a flashing visual alarm. It appears when reaching the temperature safety limit, and the control system turns off the heater. Once the system air temperature returns to a safe operating temperature of between 34ºC and 37ºC, the heater will turn back on. If the control system determines the heater again exceeds the safety limit, the warming system alarms once more. Take the warming system out of service for repair by a qualified service technician. If a power failure occurs while the warming system is in the over-temperature fault condition, and the warming system is still in the over-temperature fault condition when 2-2
WarmTouch™ Model WT-5800 Patient Warming System Operator’s Manual
Introduction
power is restored, continuous audible and visual alarms will activate. In this instance, the over-temperature fault cannot be cleared. Take the warming system out of service for repair by a qualified service technician.
2.5.5 HEPA Filter Caution The HEPA filter must be changed every 2,000 hours of operation. Refer to the Routine Maintenance section in the Service Manual for replacement procedures requiring a qualified technician. The system's High Efficiency Particulate Air Filter is 99.97% efficient at 0.3-micron particle size.
2.5.6 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. Figure 2-1. Cart Wheel Lock
WarmTouch™ Model WT-5800 Patient Warming System Operator’s Manual
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Introduction
2.6
Symbols The symbols identified are the symbols used on the warming system and warming system labeling.
Table 2-1: Symbols on the Warming Unit Attention symbol, consult accompanying documentation
Do not direct air from the hose to the patient (free-hosing); use hose only with warming blankets.
Dangerous voltage
Protection Class I Protection Type BF
Date of manufacture
Visual and audible alert
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WarmTouch™ Model WT-5800 Patient Warming System Operator’s Manual
Introduction
Table 2-2: Symbols on the Warming Unit Shipping Label Keep away from sunlight
Keep upright, this side up
Fragile
Keep dry
Relative humidity limitations: 15% to 95%
Temperature limitations: -40°C to +70°C
Serial Number Reference Code
WarmTouch™ Model WT-5800 Patient Warming System Operator’s Manual
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Introduction
2.7
Description of the Warming System The warming system blankets are intended for prevention and treatment of hypothermia. For example, use the warming system with the surgical patient, the patient in the preoperative holding area, the pregnant woman who shivers during epidural anesthesia due to hypothermia, or any patient who is uncomfortable in the cold critical care environment. Figure 2-2. Front View
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Hose
4
Power Cord
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Main Power Switch
5
Hour Meter
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Nozel
6
Control Panel
Figure 2-3. Control Panel Warning Indicator and Temperature Selection Keys
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WarmTouch™ Model WT-5800 Patient Warming System Operator’s Manual
Introduction
Figure 2-4. Back View
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Over-Temperature Test Port
5
Filter Cover
2
Instruction Label
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Bed Hook Bracket
3
Blower Cart Clamp
7
Nozzle Strap with Clip
4
Warning Label
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WarmTouch™ Model WT-5800 Patient Warming System Operator’s Manual
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Installation
3.1
Overview This chapter contains information for installing the WarmTouch™ Model WT-5800 patient warming system.
Installation
3.2
Cart Installation The warming system is shipped installed on the warming system cart. Ensure the three blower cart clamps are tight. Figure 3-1. Maximum Mounted Height
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WarmTouch™ Model WT-5800 Patient Warming System Operator’s Manual
Installation
3.3
IV Pole Installation The warming system should not be installed on the IV pole with the handle higher than 76 centimeters (30 inches). Figure 3-2. Maximum IV Pole Installation Height
WarmTouch™ Model WT-5800 Patient Warming System Operator’s Manual
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Installation
3.4
Patient Bed Installation The patient rail connectors will fit on bed rails up to 1.4 inches (3.6 centimeters) wide. Figure 3-3. Bed Rail Installation
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WarmTouch™ Model WT-5800 Patient Warming System Operator’s Manual
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Using the Warming System
4.1
Overview This chapter provides information on operating the WarmTouch™ Model WT-5800 patient warming system.
4.2
Power Supply Cord Plug the warming system power cord into a hospital grade or suitable mains outlet.
4.3
Main Power Warning No free-hosing. Keep hose nozzle connected to a WarmTouch™ blanket at all times or thermal injury may occur.
Warning Thermal injury may occur if the warming system hose comes into contact with the patient.