gaymar TC3000 Operator's Manual

®
Thermacare TC3000
Convective Warming System Aparato de calentamiento convectivo
Operating Manual Manual del usuario
P/N 09033-000 7/96
60°F - 85°F
(16°C - 29°C)
Before you begin . . .
Important
The Thermacare TC3000 Convective Warming Unit is compatible with model TC1050, TC2050, TC2052, TC2054, and TC2060 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 TC3000 Convective Warming System.
We suggest that a biomedical engineer perform the FUNCTIONAL CHECK AND SAFETY INSPECTION regularly to assure the TC3000 Power Unit works properly (refer to TC3000 Service Manual).
Review the SAFETY PRECAUTIONS in section
1.0 (pp. 2-3) prior to each application.
Symbols used within this manual:
Attention: consult accompanying documents
Dangerous voltage
Protective earth (ground)
Type BF applied equipment
Off-on switch
MIN (Fan Only)
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 TC3000 Service Manual instructions.
LOW (90°F, 32°C)
MED (100°F, 38°C)
HIGH (110°F, 43°C)
MAX (115°F, 46°C)
REMOVE FROM USE (indicator light, amber color)
Do not use in operating room (OR) or Intensive Care Unit (ICU)
Ambient operating temperature
© 1996. Gaymar Industries, Inc. All rights reserved.
Table of Contents
Table of Contents
Section Description Page
1.0 Safety Precautions ................................................................ 2
2.0 Introduction ........................................................................... 4
3.0 Operator Control Panel........................................................... 5
4.0 Operating Instructions ........................................................... 6
5.0 Routine Maintenance ............................................................. 7
6.0 Troubleshooting ..................................................................... 8
7.0 Quilts / Training / Warranty / Returns ...................................... 8
8.0 Specifications........................................................................ 9
Illustrations
Figure Description Page
1 Convective Warming System ................................................. 4
2 Power Unit Mounting ............................................................. 4
3 Pole Mounting Height Limit .................................................... 4
4 Operator Control Panel........................................................... 5
5 Attaching Hose to Quilt .......................................................... 6
Tables
Table Description Page
1 Setting the Prescribed Temperature ........................................ 6
1
Section 1 - Safety Precautions
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.
DANGER
Explosive hazard. Do not use in the presence of flammable anesthetics.
Risk of electric shock. Disconnect power before servicing the TC3000 Power Unit.
WARNING
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, temperature­sensitive, and postoperative patients should be checked more frequently. If the patient's temperature is within the
(continued next column)
WARNING
prescribed range, select a lower temperature setting or discontinue therapy. If vital signs become unstable, notify the attending physician immediately.
When treating hemodynamically unstable patients, start therapy at LOW (90°F, 32°C) or MED (100°F, 38°C) temperature setting.
Do not apply heat to lower extremities during aortic cross-clamping. Ischemic injury may occur.
Do not use the MAX (115°F, 46°C) temperature setting in the operating room.
Do not use the TC3000 Power Unit in the MAX (115°F, 46°C) temperature setting when using the TC2050, TC2052, TC2054, or TC2060 Warming Quilts.
Do not use the MAX (115°F, 46°C) temperature setting for patients with any of the following conditions:
1.Low cardiac output
2.Poor peripheral perfusion or peripheral vascular disease
3.Total immobilization
4.Non-sensate patients
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.
2
Section 1 - Safety Precautions (cont’d)
1.0 Safety Precautions (cont’d)
CAUTION
• 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.
3
I. V. Pole Clamp
Section 2 - Introduction
2.0 Introduction
Please read the precautions found in section 1.0 and all operating instructions before attempting to use the Thermacare TC3000 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 TC3000 Power Unit
The TC3000 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 five temperature settings -- MIN (fan only),
LOW (90°F, 32°C), MED (100°F, 38°C), HIGH (110°F, 43°C), and MAX (115°F, 46°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).
CAUTION
Figure 1 - Convective Warming System
Figure 2A - I. V. Pole or Stand mounted
Bedrail Hook
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.
4
Figure 2B - Bed rail mounted
CAUTION
Do not mount higher than 3 ft.
Figure 3 - Pole mounting height limit
Section 3 - Operator Control Panel
®
Figure 4 - Operator Control Panel
À
3.0 Operator Control Panel
The operator controls are identified in figure 4.
Á
®
WARNING
Failure to follow the following precautions could result in death or serious injury:
Do not use the MAX (115°F, 46°C)
setting in the operating room.
Do not use the MAX (115°F, 46°C) setting for patients with any of the following conditions:
1.Low cardiac output
2.Poor peripheral perfusion or
peripheral vascular disease
3.Total immobilization
4.Non-sensate patients
Â
3.1 POWER Switch À
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 Á
When the Power Unit is turned on, the system defaults to the LOW (90°F, 32°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), HIGH (110°F, 43°C), or MAX (115°F, 46°C).
If electrical power is momentarily interrupted, the existing temperature setting will remain. If electrical power remains off, the TC3000 will default to LOW (90°F, 32°C) when power is restored.
3.3 REMOVE FROM USE Indicator Â
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.
CAUTION
If the REMOVE FROM USE indicator lights, turn the Power Unit off immediately. Discontinue use and refer equipment for servicing.
5
Section 4 - Operating Instructions
IMPORTANT
3. Insert the end of the hose into the Quilt opening (fig. 5). Secure the hose tightly.
Read and understand these instructions and the precautions on the inside front cover before using the TC3000 Power Unit.
Any application of the TC3000 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 TC3000 Convective Warming System is placed into operation:
1. Select the location for operation of the TC3000 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.
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 LOW (90°F, 32°C) setting. Select the prescribed temperature you desire for the patient (see table 1).
Temperature Setting Temperature
MIN Fan only
LOW 90°F (32°C)
MED 100°F (38°C)
HIGH 110°F (43°C)
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.
opening
hose
collar
Figure 5 - Attaching hose to Quilt
6
MAX 115°F (46°C)
Table 1 - Setting the prescribed temperature
collar
tab
strap
strap
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