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Model WT-5300A Patient Warming System
Operator’s Manual
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© 2010 Nellcor Puritan Bennett LLC. All rights reserved.
To obtain warranty information contact your local Nellcor representative.
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Table of Contents
Safety Information ............................................................................................. 5
Overview........................................................................................................ 5
Safety Information........................................................................................ 5
Warnings ................................................................................................. 6
Cautions................................................................................................... 7
Introduction ........................................................................................................ 9
Overview........................................................................................................ 9
Intended Use ................................................................................................. 9
Manual Availability....................................................................................... 9
Background Information.............................................................................. 9
Safety Features............................................................................................ 10
Customized Warming Therapy............................................................. 10
Automatic Temperature Stepdown ..................................................... 10
Automatic Over Temperature Shutdown............................................ 10
Alarms.................................................................................................... 11
HEPA Filter............................................................................................. 12
Wheel Locks........................................................................................... 12
Symbols........................................................................................................ 13
Description of the Warming System.......................................................... 14
Installation ........................................................................................................ 17
Overview...................................................................................................... 17
Cart Installation........................................................................................... 18
IV Pole Installation...................................................................................... 19
Patient Bed Installation .............................................................................. 20
Using the Warming System ............................................................................. 21
Overview...................................................................................................... 21
Power Supply Cord...................................................................................... 21
Main Power ................................................................................................. 21
Temperature Control.................................................................................. 22
Air Filter....................................................................................................... 23
Self-Supporting Air Hose............................................................................ 23
Using WarmTouch™ CareQuilt™ and CareDrape™ Blankets ................. 23
Routine Maintenance ....................................................................................... 25
Overview...................................................................................................... 25
Cleaning the Warming System................................................................... 25
Routine Maintenance ................................................................................. 25
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Specifications .................................................................................................... 27
Overview...................................................................................................... 27
Warming System Specifications ................................................................. 27
Transport and Shipping in Shipping Container ........................................ 28
Compliance.................................................................................................. 28
Manufacturer’s Declaration ................................................................. 29
Electromagnetic Compatibility (EMC).................................................. 29
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1 Safety Information
Overview
This manual contains information for using the WarmTouch™ Model WT-5300A 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.nellcor.com/serv/manuals.aspx
Safety Information
Overview
This section contains safety information requiring users to exercise appropriate
caution while using the warming system.
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.
The CAUTION symbol identifies cautions.
Cautions alert the user to exercise care necessary for the safe and effective use
of the warming system.
The NOTE symbol identifies notes.
Notes contain important information that may otherwise be overlooked or
missed.
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Safety Information
Warnings
WARNING
Possible explosion hazard. Do not use this 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
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.
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.
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WARNING
WarmTouch™ CareDrape™ and CareQuilt™ blankets are for single patient
use only.
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.
Safety Information
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.
Cautions
Caution
Federal (U.S.A.) law restricts the use of the warming system to sale by or on the order
of a physician.
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Safety Information
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 that the patient is dry or the warming system may be ineffective.
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1 Introduction
Overview
This chapter provides an introduction to the WarmTouch™ Model WT-5300A
patient warming system.
Intended Use
The WarmTouch™ Model WT-5300A 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.
Overview
Manual Availability
The most recent revision of this manual is available on the Internet at:
http://www.nellcor.com/serv/manuals.aspx
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.
covers the patient with warm air and actively transfers heat across the skin. The
result is to achieve normothermia.
1
Morris RH, Wilkey BR. “The Effects of the Ambient Temperature on Patient Temperature
During Surgery Not Involving Body Cavities.” Anesthesiology 32:102
2
Morris RH. “Influence of Ambient Temperature on Patient Temperature During
Intra
-abdominal Surgery.” Annals of Surgery 173:230-233, 1971.
1, 2
The warming system
-107, 1970.
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Introduction
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.
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 a 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 Boost Mode, blower temperature will automatically drop to the high
temperature setting after each 45 minutes of use. The temperature may be reset
to Boost Mode by selecting the boost temperature setting on the control panel
to start another 45-minute cycle.
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 warning light, and sounds an
audible alarm. The warming system heater will start producing heat when the
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warming system temperature drops to between approximately 34ºC and 37ºC.
A yellow warning light illuminates whenever the control system identifies an
over-temperature condition.
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.
Safety Features
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 power is restored, continuous audible
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.
and visual alarms will
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Introduction
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.
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 1. Cart Wheel Lock
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Symbols
The symbols identified are symbols used on the warming system and warming
system labeling.
Table1.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
Symbols
Protection Class I
Protection Type BF
Date of manufacture
Visual and audible alert
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Introduction
Table2.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
Serial Number
Reference Code
°C to +70°C
Description of the Warming System
The warming system CareQuilt™ and CareDrape™ 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.
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Figure 2. Front View
Description of the Warming System
1 — Hose 4 — Power Cord
2
— Main Power Switch 5 — Hour Meter
3
— Nozzle 6 — Control Panel
Figure 3. Control Panel Warning Indicator and Temperature Selection Keys
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Introduction
Figure 4. Back View
1 — Over-Temperature Test Port 5 — Filter Cover
2 — Instruction Label 6 — Bed Hook Bracket
3 — Blower Cart Clamp 7 — Nozzle Strap with Clip
4 — Warning Label
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1 Installation
Overview
This chapter contains information for installing the WarmTouch™ Model WT-5300A
patient warming system.
Overview
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Installation
Cart Installation
The warming system is shipped installed on the warming system cart. Ensure
the three blower cart clamps are tight.
Figure 5. Maximum Mounted Height
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IV Pole Installation
The warming system should not be installed on the IV pole with the handle
higher than 76 centimeters (30 inches).
Figure 6. Maximum IV Pole Installation Height
IV Pole Installation
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Installation
Patient Bed Installation
The patient rail connectors will fit on bed rails up to 1.4 inches (3.6 centimeters)
wide.
Figure 7. Bed Rail Installation
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Overview
1
Using the Warming System
Overview
This chapter provides information on operating the WarmTouch™ Model WT-5300A
patient warming system.
Power Supply Cord
Plug the warming system power cord into a hospital grade or suitable mains
outlet.
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.
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. The Low temperature light on the control panel illuminates, the
warming system begins blowing low temperature air, and the power fail alarm
sounds. Press the desired temperature key to cancel the alarm.
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Using the Warming System
Temperature Control
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.
Figure 8. Low Temperature Light
WARNING
Using the warming system on transdermal medication patches may increase
the rate of drug delivery, potentially causing harm to the patient.
The control panel features a warning light indicator and four manually-switched
temperature settings. The warning light indicates the control system has
identified an alarm condition and an action by the operator is required. Each
temperature setting represents the average temperature of air entering the
hose.
Low 32°C (89.6°F)
•
• Medium 38°C (100.4°F)
• High 43°C (109.4°F)
• Boost 45°C (113°F) for 45 minutes
For patients with severe hypothermia requiring rapid warming, select the Boost
temperature setting. To help prevent hypothermia or for treatment of mild
hypothermia, select High, Medium or Low temperature settings. The selected
temperature light illuminates.
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Air Filter
Caution
The HEPA filter must be changed every 2,000 hours of operation. Refer to the
Routine Maintenance section in the WT5300A Service Manual for replacement
procedures requiring a qualified technician.
The warming system contains a HEPA filter rated 99.97% efficient at 0.3-micron
particle size.
Self-Supporting Air Hose
Air is delivered into the CareQuilt™ or CareDrape™ blankets through a
wire-reinforced hose attached to the warming system.
Air Filter
Using WarmTouch™ CareQuilt™ and CareDrape™ Blankets
WarmTouch™ CareQuilt™ and CareDrape™ blankets come in a range of sizes and
configurations to fit patient individual sizes, surgical procedures, and comfort
needs. Follow the instructions provided with all WarmTouch™ blankets for
specific information concerning their recommended use.
Use only WarmTouch™ blankets. The performance of the WarmTouch™ patient
warming system has only been evaluated and validated using WarmTouch™
blankets.
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Using the Warming System
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1 Routine Maintenance
Overview
This chapter describes the steps required to maintain, service, and properly
clean the WarmTouch™ Model WT-5300A patient warming system.
Cleaning the Warming System
Caution
Do not spray, pour, or spill any liquid on the warming system, its accessories,
connectors, switches, or openings in the case.
Overview
For surface cleaning and disinfection of the warming system, 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 system.
• Disinfection — Use a soft cloth saturated with a solution of 10% chlorine
bleach in tap water, lightly wiping the surfaces of the warming system.
Routine Maintenance
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.
For routine maintenance procedures requiring a qualified technician, including
testing and verifying operation of the independent over-temperature safety
system and the subsequent over-temperature alarm, refer to the Routine
Maintenance section of the Service Manual.
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Routine Maintenance
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1 Specifications
Overview
This chapter contains physical and operational specifications for the
WarmTouch™ Model WT-5300A patient warming system.
Warming System Specifications
Table3.System Specifications
Warming Blanket Specifications
Overview
Maximum blanket surface temperature 44
Blower Specifications
Dimensions 38 cm x 41 cm x 28 cm
Weight 6.8 kgs (15 lbs.)
Power Requirements 120 volts AC, 50/60 Hz, 10 amp
Automatic Temperature Stepdown
(Boost to High Temperature)
Power Supply Cord 4.26 m (14 feet)
Thermal Protection Threshold Thermostat (internal): 47
Ambient Blower
Operating Temperature Range
Over Temperature Alarm Level 65 dB at 3 meters
Protection Against Ingress of Fluids Ordinary
Cart Specifications
Weight 3.1 kg (6.8 pounds)
°C
(15 inches x 16 inches x 11 inches)
After 45 minutes of continuous use blower will
step down from the Boost to High setting.
°C to 50°C
(117
°F - 122°F)
18
°C - 28°C (64.4°F - 82.4°F)
Height 67.1 cm (26.4 inches)
Width 32.3 cm (12.7 inches)
Depth 38.6 cm (15.2 inches)
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Specifications
Transport and Shipping in Shipping Container
Table4.Shipping Container Specifications
Temperature: -40ºC to 70ºC (-40ºF to 158ºF)
Altitude: -390 m to 6,096 m (-1,280 ft to 20,000 ft)
Barometric Pressure: 1,060 hPa to 500 hPa (375 mmHg to 795 mmHg)
Relative Humidity: 15% to 95% (non-condensing)
Compliance
Table5.Compliance Standards
Item Compliant With
Equipment classification IEC/EN 60601-1 2nd edition
CSA C22.2 No. 601.1 M90
UL 60601-1 1st edition
IEC 60601-2-35: 1996
EN 60601-2-35: 1997
Type of protection Class I (on AC power)
Degree of protection Type BF - Applied part
Mode of operation Continuous
Electromagnetic Compatibility IEC/EN 60601-1-2 3rd edition
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Manufacturer’s Declaration
WARNING
The use of accessories and cables other than those specified may result in
increased emission and/or decreased immunity of the warming system.
The warming system is suitable for use in the specified electromagnetic
environment. The customer and/or user of the warming system should ensure it
is used in the prescribed electromagnetic environment.
Electromagnetic Compatibility (EMC)
Electromagnetic Emissions
Table6.Electromagnetic Emissions Guidelines
Compliance
Emissions Test Compliance Electromagnetic Environment Guidance
RF emission
CISPR 11
Group 1
Class A
The warming system uses RF energy only for its
internal function. Therefore, its RF emissions are very
low and not likely to cause any interference in
nearby electronic equipment.
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Specifications
Electromagnetic Immunity
These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.
Table7.Electromagnetic Immunity Guidelines
Immunity Test
Electrostatic
discharge (ESD)
IEC/EN 61000-4-2
Electric fast
transient/burst
IEC/EN 61000-4-4
Surge
IEC/EN 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
IEC
/EN
61000-4-11
EN 60601-1-2
Test Level
±6 kV contact
±8 kV air
± 2 kV for power
supply lines
± 1 kV for input/
output lines
± 1 kV
differential mode
± 2 kV common
mode
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for five cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(95% dip in UT)
for five seconds
Compliance
Level
±6 kV contact
±8 kV air
± 2 kV for power
supply lines
± 1 kV for input/
output lines
± 1 kV
differential mode
± 2 kV common
mode
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for five cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(95% dip in UT)
for five seconds
Electromagnetic Environment
Guidance
Floor should be wood, concrete, or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
Mains power quality should be that
of a typical commercial and/or
hospital environment.
Mains power quality should be that
of a typical commercial and/or
hospital environment.
Mains power quality should be that
of a typical commercial and/or
hospital environment.
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.
Note: UT is the AC main’s voltage
prior to application of the test level.
Power frequency
(50/60 Hz)
magnetic field
IEC/EN 61000-4-8
30 Operator’s Manual
3 A/m 3 A/m It may be necessary to position the
warming system further from the
sources of power frequency
magnetic fields or to install
magnetic shielding. The power
frequency magnetic field should be
measured in the intended
installation location to assure that it
is sufficiently low.
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For transmitters rated at a maximum output power not listed, estimate the
separation distance 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:
Portable and mobile RF communications equipment should be used no closer to any
part of the warming system, including cables, than the recommended separation
distance calculated from the equation appropriate for the frequency of the
transmitter.
Table8.Recommended Separation Distances
Compliance
Immunity Test
Radiated RF
/EN
61000-4-3
IEC
Conducted RF
/EN
61000-4-6
IEC
Rated Maximum
Output Power of
Transmitter in
Watts Separation Distance in Meters
0.010 0.120 0.035 0.070
0.100 0.380 0.110 0.220
1.000 1.200 0.350 0.700
EN 60601-1-2 Test
Level Compliance Level
Frequency of
Transmitter
3 V/m
80 MHz
800 MHz
3 V/m
800 MHz
2.5 GHz
3 Vrms
150 kHz
80 MHz
10 V/m Distance =
10 V/m Distance =
3 Vrms Distance =
Electromagnetic
Environment Guidance
Equation for Separation
80 MHz to 800 MHz
800 MHz to 2.5 GHz
150 kHz to 800 MHz
Distance
0.35
0.7
1.2
P
P
P
10.000 3.800 1.120 2.210
100.000 12.000 3.500 7.000
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Specifications
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32 Operator’s Manual
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Index
A
Air filter, 23
Air hose, 23
Automatic temperature shutdown, 10
B
Bed rail installation, 20
Burn hazard, 6
C
CareDrape, 23
CareQuilt, 23
Cart installation, 18
Cleaning, 25
Control Panel, 15
Customized warming therapy, 10
D
Disinfection, 25
E
Electric shock, 6
Electrical shock hazard, 6
Explosion hazard, 6
F
Fire hazard, 6
I
Introduction, 9
IV pole installation, 19
M
Main power, 21
Manufacturer’s declaration, 29
MRI warning, 7
P
Patient bed installation, 20
Patient burns, 6
Possible explosion hazard, 6
Power supply cord, 21
R
Routine maintenance, 25
S
Safety features, 10
Safety information, 5
Single patient use, 7
Specifications, 27
Surface cleaning, 25
T
Temperature control, 22
U
Using the warming system, 21
W
Warning light, 11
Warnings, 6
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34 Operator’s Manual
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Tyco Healthcare Group LP
Nellcor Puritan Bennett LLC
4280 Hacienda Drive
Pleasanton, CA 94588 USA
Toll Free: 1.800.635.5267
© 2010 Nellcor Puritan Bennett LLC
All rights reserved.
Manufactured in the U.S.A.
10064187 Rev B 09/2010
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