Gaymar Thermacare TC3146 User manual

Thermacare TC3146
Convective Warming System
Système de réchauffement par convection
Aparato de calentamiento convectivo
P/N 12536000 Rev A 12/07
Operating Manual
Manuel d'utilisation
Manual del usuario

Attention: consult accompanying
documents
Dangerous voltage
Protective earth (ground)
Type BF applied equipment
MIN (Fan Only)
LOW (90°F, 32°C)
MED (100°F, 38°C)
HIGH (110°F, 43°C)
Do not use in operating room
(OR) or Intensive Care Unit (ICU)
Off-on switch
REMOVE FROM USE
(indicator light, amber color)
Symbols used within this manual:
60°F -85°F
(16°C -29°C)
Ambient operating temperature
Important
The Thermacare TC3146 Convective Warming
Unit is compatible with model TC1050,
TC1050N, TC2050, TC2050N, TC2052,
TC2052N, TC2054, TC2054N, TC2060 and
TC2061 Warming Quilts.
The Thermacare Convective Warming System
(figure 1, page 4) provides a continuous means
of warming patients to help prevent and/or
treat hypothermia. The system consists of a
Convective Warming Unit (Power Unit) and a
disposable Quilt. A connecting hose conducts
heated air from the Power Unit to the Quilt.
Read and understand the Operator's Manual
and all precautions prior to using the TC3146
Convective Warming System.
We suggest that a biomedical engineer
perform the FUNCTIONAL CHECK AND SAFETY
INSPECTION regularly to assure the TC3146
Power Unit works properly (refer to TC3146
Service Manual).
Review the SAFETY PRECAUTIONS in section
1.0 (pp. 2-3) prior to each application.
Receiving Inspection
Upon receipt, unpack the Power Unit. Save
all packing material. Perform a visual and
mechanical inspection for concealed damage. If
any damage is found, notify the carrier at once
and ask for a written inspection. Photograph
any damage and prepare a written record.
Failure to do so within 15 days may result in
loss of claim.
Contact your local dealer or contact Gaymar's
Technical Service Department (see back cover
for phone numbers) for assistance.
NOTE: Extremely high storage temperatures
(such as those found in rail cars or automobile
trunks on hot summer days) can cause the
overtemp thermostats within this device to
actuate. Should this occur, the REMOVE FROM
USE indicator will light when the Power Unit
is turned on. If this happens, the thermostats
must be manually reset by qualified personnel
such as certified biomedical electronics
technicians or certified clinical engineers
according to the TC3146 Service Manual
instructions.
Before you begin . . .
60oF - 85oF
(16oC - 29oC)

1
Table of Contents
Table of Contents
Section Description Page
1.0 Safety Precautions ................................................................. 2
2.0 Introduction ........................................................................... 3
3.0 Operator Control Panel ........................................................... 4
4.0 Operating Instructions............................................................ 5
5.0 Routine Maintenance.............................................................. 6
6.0 Troubleshooting ..................................................................... 7
7.0 Quilts / Training / Warranty / Returns ...................................... 7
8.0 Specifications ........................................................................ 8
Illustrations
Figure Description Page
1 Convective Warming System.................................................. 3
2 Power Unit Mounting.............................................................. 3
3 Pole Mounting Height Limit..................................................... 3
4 Operator Control Panel ........................................................... 4
5 Attaching Hose to Quilt........................................................... 5
Tables
Table Description Page
1 Setting the Prescribed Temperature ........................................ 5

1.0 Safety Precautions
Review the following SAFETY PRECAUTIONS
prior to using the Power Unit. These SAFETY
PRECAUTIONS appear within this manual, the
Power Unit label, or the Quilt Instructions for Use.
This device generates heated air flow.
Excessive heat could cause thermal
stress or skin lesions. Failure to follow
these precautions could result in death or
serious injury:
• Use the Convective Warming System
only under direction of a physician. A
physician's order is required for setting
temperature and for continued use of
equipment.
• If the patient's temperature is not
responding or does not reach the
prescribed temperature in the prescribed
time, or deviates from the prescribed
temperature range, notify the attending
physician promptly.
•Monitor core temperature. Neonates and
pediatric patients of low weight will have
a tendency to overheat more readily than
adults. Failure to monitor core temperature
could result in abnormal elevation of body
temperature resulting in death or serious
injury.
•Monitor the patient's temperature, vital
signs, and skin condition regularly
(every 20 minutes or as prescribed by
a physician). Pediatric, temperature-
sensitive, and postoperative patients
should be checked more frequently.
If the patient's temperature is within
the prescribed range, select a lower
temperature setting or discontinue therapy.
•Explosive hazard. Do not use in the
presence of flammable anesthetics.
•Risk of electric shock. Disconnect power
before servicing the TC3146 Power Unit.
2
If vital signs become unstable, notify the
attending physician immediately.
•Do not apply heat to lower extremities
during aortic cross-clamping. Ischemic
injury may occur.
•Do not apply heat to ischemic tissue.
•Do not use the Power Unit unless the
hose is connected to a warming quilt.
Place your hand under the quilt to verify
the air is warm.
• Use this Power Unit only with those quilts
recommended by the manufacturer (see
inside cover of this manual for list).
•Repairs should be performed only by
qualified personnel such as certified
biomedical electronics technicians or
certified clinical engineers familiar with
repair practices for servicing medical
devices, and in accordance with the
Service Manual. Damage to the Power
Unit or malfunction could otherwise
result.
Section 1 - Safety Precautions
(continued next column)
•U. S. Federal law restricts this
device to sale by or on the order of a
physician.
•Evaporative cooling may result if the
patient's skin is not dry.
•Do not permit air from the quilt to blow
onto an open wound. Convective airflow
can cause airborne contamination to
open wounds. Use tape on quilt to restrict
movement of air toward the surgical site.
• For grounding reliability, plug only into
a grounded outlet labelled “Hospital
Grade.”
•When using an I. V. pole, do not mount
the Power Unit higher than 3 feet
(0.9 meter). Otherwise, the Power Unit
could tip over.
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3
2.0 Introduction
Please read the precautions found in section 1.0
and all operating instructions before attempting to
use the Thermacare TC3146 Convective Warming
System. In addition, we recommend you request
in-service training from your local dealer.
2.1 Convective Warming System
The Convective Warming System (fig. 1) provides
a continuous means of warming patients to help
prevent and/or treat hypothermia. The system
consists of a Convective Warming Unit (Power
Unit) and a disposable Quilt. A connecting hose
conducts heated air from the Power Unit to the
Quilt.
2.2 TC3146 Power Unit
The TC3146 Power Unit provides a continuous
source of air to the Quilt. The Power Unit consists
of a HEPA filter, blower, heater, and temperature
controller. Exiting air temperatures may be set to
one of four temperature settings -- MIN (fan only),
LOW (90°F, 32°C), MED (100°F, 38°C), and HIGH
(110°F, 43°C)-- as appropriate for the application.
The Power Unit can be operated while hanging on
the rails of a bed, stretcher, on an I. V. pole, or on
an optional stand (figs. 2A/2B).
When using an I. V. pole, do not mount the
Power Unit higher than 3 feet (0.9 meter)
(see figure 3).
Otherwise, the Power Unit could tip over.
2.3 Quilt
The Quilt distributes air over the covered areas
of the patient through openings in the patient side
of the Quilt. Quilts consist of layers of plastic
and nonwoven material bonded together. On
operating room model Quilts, a pressure-sensitive,
nonirritating tape provides a seal between the air
from the Quilt and the surgical site. Refer to the
instructions enclosed with each Quilt.
Figure 3 - Pole mounting height limit
Figure 1 - Convective Warming System
Figure 2A - I. V. Pole or Stand mounted
I.V.Pole
Clam p
Bedrail
Hook
Figure 2B - Bed rail mounted
Do notm ount
higherthan 3 ft.
CAUTION
Section 2 - Introduction
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IV Pole
Clamp
Bedrail
Hook
2 - 3ft.
.6 - .9m
CAUTION
Do not mount
higher than 3ft.

Section 3 - Operator Control Panel
➁➂
4
3.3 REMOVE FROM USE Indicator ➂
The REMOVE FROM USE indicator will light:
•ifapatientlimitthermostatorheater
overtemp thermostat has tripped, or
•iftheHEPAfilterhasbeeninstalled
incorrectly or is missing.
The heating element and blower will automatically
turn off when either of these conditions occur.
If the REMOVE FROM USE indicator
lights, turn the Power Unit off
immediately. Discontinue use and refer
equipment for servicing.
Figure 4 - Operator Control Panel
➀
3.0 Operator Control Panel
The operator controls are identified in figure 4.
3.1 POWER Switch ➀
The POWER switch controls power to the Power
Unit. The POWER INDICATOR light in the switch
will be lit when power is on.
3.2 TEMPERATURE SETTING
Push Buttons ➁
When the Power Unit is turned on, the system
defaults to the MED (100°F, 38°C) temperature
setting.
Temperature settings are selected by pressing the
appropriate push button-- MIN (fan only), LOW
(90°F, 32°C), MED (100°F, 38°C) or HIGH (110°F,
43°C).
If electrical power is momentarily interrupted, the
existing temperature setting will remain. If electrical
power remains off, the TC3146 will default to MED
(100°F, 38°C) when power is restored.
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5
IMPORTANT
Read and understand these instructions
and the precautions on the inside front
cover before using the TC3146 Power Unit.
Any application of the TC3146 Convective
warming System must be under the
direction of the attending physician.
4.0 Operating Instructions
Perform the following start-up procedure each
time the TC3146 Convective Warming System is
placed into operation:
1. Select the location for operation of the
TC3146 Power Unit. Mount it using the bed
rail hooks, pole clamp, or set it on a flat,
hard surface. If mounting unit to an I. V. pole,
insure unit is mounted no higher than 3 feet
(0.9 meter). Keep the air inlets at the bottom
of the unit clear of any obstructions. Do not
set unit on a bed surface.
NOTE: If Power Unit is placed on the floor,
increased levels of dust could reduce filter
life.
2. Remove the Quilt from its packaging. Unfold
the Quilt and place it over the patient. Refer
to the Instructions for Use and Safety
Precautions included with each Quilt.
3. Insert the end of the hose into the Quilt
opening (fig. 5). Secure the hose tightly.
4. Plug the Power Unit into a “Hospital Grade”
outlet.
5. Turn the power on.
6. When the Power Unit is turned on, it defaults
to the MED (100°F, 38°C) setting. Select the
prescribed temperature you desire for the
patient (see table 1).
Table 1 - Setting the prescribed temperature
Section 4 - Operating Instructions
Figure 5 - Attaching hose to Quilt
strap
collar
tab
strap
collar
opening
hose
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NIMylnonaF
WOL )C°23(F°09
DEM )C°83(F°001
HGIH )C°34(F°011
MIN
LOW
MED
HIGH
Fan only
90°F (32°C)
100°F (38°C)
110°F (43°C)
Temperature Setting Temperature
opening
tab
strap
collar
hose
collar
strap

Section 4 - Operating Instructions (cont’d)
Section 5 - Routine Maintenance
NOTE:
•The air temperature surrounding the patient will
vary at each setting, depending upon room air
temperature and the quality of the insulating
blanket or sheet that is used over the Quilt.
•Operate the Power Unit only in the specified
ambient temperature and voltage ranges (see
Specifications, page 8).
7. Place your hand under the quilt to verify that
the Power Unit is warming when set to the
LOW (90°F, 32°C), MED (100°F, 38°C) or HIGH
(110°F, 43°C) temperature settings.
8. Place a sheet or blanket over the inflated
Quilt to maximize the efficiency and minimize
the heat loss from the system.
Monitor the patient's temperature, vital
signs, and skin condition regularly
(every 20 minutes or as prescribed by
a physician). If patient's temperature
reaches the normal range, reduce air
temperature or discontinue therapy. If
vital signs become unstable, notify the
attending physician immediately. Failure
to follow these precautions could result
in death or serious injury.
9. If the REMOVE FROM USE indicator lights,
discontinue use. Refer servicing to qualified
personnel.
4.10 Shutdown Procedure
When therapy has been completed, turn the
unit off and disconnect the hose from the Quilt.
Discard the Quilt.
5.0 Routine Maintenance
The following routine maintenance procedures
will help insure dependable operation:
5.1 Cleaning the Power Unit
Clean the control panel, enclosure exterior,
and hose with a soft cloth lightly dampened
with a nonstaining hospital disinfectant. Clean
accumulated dirt from the air vents with a
vacuum cleaner.
5.2 Storing the Hose
Slide the hose under the bed rail hooks on the
back of the Power Unit when not in use.
5.3 Storing the Power Cord
Coil the power cord. Hold it in place with the
strap on the side of the Power Unit. Or, hang the
power cord from the bracket on the back of the
accessory stand.
5.4 Quilt Care
Refer to the instructions included with each Quilt
for details on correct application and use. Small
rips or tears in Quilt material may be repaired with
adhesive tape.
Quilts are not sterile.
Quilts are intended for single patient use only.
Quilts should be discarded after use.
5.5 Servicing the Equipment
Repairs to the Power Unit should be
performed by qualified personnel such
as certified biomedical electronics
technicians or clinical engineers familiar
with repair practices for servicing
medical devices, and in accordance with
the TC3146 Service Manual. Damage
to the Power Unit or malfunction may
otherwise result.
6
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7
5.6 Changing the Filter
Filters must be changed only by qualified service
personnel. Refer to the TC3146 Service Manual for
instructions on replacing the filter. Under normal
use, replace the HEPA filter inside the Power
Unit every 1000 operating hours or 12 months,
whichever occurs first.
6.0 Troubleshooting
Most Power Unit operating problems are minor
and can be corrected by the operator. The
following are troubleshooting hints. Perform
corrective action in the sequence listed.
6.1 Quilt Will Not Inflate
1. Make sure the Power Unit is plugged in and
turned on.
2. Check both ends of hose for proper
connection.
3. Check hose and quilt inlet for kinks.
4. Check Quilt for damage. If air is flowing from
hose, try another Quilt. (Small rips or tears
in the Quilt may be temporarily repaired with
adhesive tape.)
5. Have qualified service personnel check for a
clogged or dirty HEPA filter.
6.2 REMOVE FROM USE Indicator is Lit
This indicates that the heater and blower have
shut down due to the air temperature exceeding
the high temperature limit, or that the filter has
been incorrectly installed or is missing. Remove
the Power Unit from use immediately. Refer
servicing to qualified personnel.
Repairs to the Power Unit should be
performed by qualified personnel such
as certified biomedical electronics
technicians or clinical engineers familiar
with repair practices for servicing medical
devices, and in accordance with TC3146
Service Manual.
Damage to the Power Unit or
malfunction may otherwise result.
7.0 Miscellaneous
7.1 Quilts
Contact your dealer for information on the model
TC1050, TC2050, TC2052, TC2054, TC1050N,
TC2050N, TC2052N, TC2054N, TC2060 and
TC2061 Quilts available for use with the TC3146
Power Unit.
7.2 Accessory Stand
An optional accessory stand for mounting the
TC3146 Power Unit is available from your local
dealer.
7.3 Customer Training
In-service training is recommended and can be
arranged through your dealer.
7.4 Limited Warranty
The Thermacare TC3146 Power Unit is warranted
free of defects in material and workmanship
under normal use and operation for a period of
two years, under the terms and conditions of the
Gaymar warranty in place at time of purchase.
Consumable items such as filters are excluded.
The full warranty is available from Gaymar upon
request.
7.5 Return Authorization
Contact your local dealer or Gaymar's Technical
Service Department at:
Phone: [phone]
[phone]
Fax: [phone]
Section 6 - Troubleshooting
Section 7 - Miscellaneous
Use only quilts recommended by
manufacturer. Failure to do so may result
in thermal injury.
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Section 8 - Specifications
8.0 Specifications
8.1 Physical
Dimensions 16 1/4"H x 10 3/4"W x 10 1/2"D
42 cm x 28 cm x 27 cm
Weight 15 lbs (6.8 kg)
Enclosure Thermoplastic
Filter HEPA filtration down to 0.3
micron particle size
8.2 Electrical
Classification Type BF, Class 1, grounded
equipment suitable for
continuous operation. Not
classified for protection against
harmful ingress of liquid.
Input 120 V nominal (+4%,-10%),
60 Hz, 12 amps max
Motor 1/25 HP, single phase
Heater 1200W heating element
Power Cord 15 ft, 14 AWG cord with
hospital grade plug
Circuit Breaker 15 amp
Current Leakage (Earth) 100 microamps max.
Ground Resistance 0.15 ohms nominal;
0.50 ohms maximum
Ambient Operating 60°F to 85°F
Temperature (16°C to 29°C)
8.3 Temperature Settings
The air temperatures are identified on the operator
control panel and indicate the average air
temperature at the hose end using a Quilt.
NOTE: The air temperature around the
patient is affected both by the ambient room
temperature and the use of an insulating
blanket on top of the Quilt.
8.4 Safety System
Dual Patient Safety Temperature Limit
Thermostats
Either of two independently operating
thermostats will shut off the TC3146 at a
preset high limit temperature. The heater
element and blower will remain off until the
thermostat is manually reset.
Heater Overtemp
Heater overtemp thermostat will shut
off the TC3146 in the event of a blower
failure or lack of air movement. The heater
element and blower will remain off until the
thermostat is manually reset.
High Temp Indicator
The REMOVE FROM USE indicator will light
on the front panel when a patient safety
thermostat or heater overtemp thermostat
has tripped. Also, the heating element and
blower will turn off.
HEPA Filter Interlock Switch
The REMOVE FROM USE indicator will light
on the front panel when the HEPA filter has
been installed incorrectly or is missing. Also,
the heating element and blower will turn off.
8.5 Quilts
All Quilts are made of a nonwoven layer bonded
to a plastic film.
Quilt material meets U. S. flammability standards:
•NFPA 702 “Normal Flammability”
•CPSC Part 1632
•California Title 19, Subchapter 7
Clear drape material meets NFPA 702 “Normal
Flammability.”
8
gnitteSerutarepmeT erutarepmeT
NIMylnonaF
WOL )C°23(F°09
DEM )C°83(F°001
HGIH )C°34(F°011
MIN
LOW
MED
HIGH
Fan only
90°F (32°C)
100°F (38°C)
110°C (43°C)
Temperature
Temperature Setting

GAYMAR INDUSTRIES, INC.
10 Centre Drive
Orchard Park, NY 14127-2295 USA
Phone:
1 800 828-7341
[phone]
Fax:
1 800 993-7890
[phone]
www.gaymar.com