Estill TA-200 User manual

TA-200 Instructions

Package Contents:

The package contains one Thermal Angel TA-200 Blood and IV Fluid Infusion Warmer. The fluid path is
sterile and non-pyrogenic in an unopened and undamaged package. Federal law restricts this device to
sale by or on the order of a physician.

Indication for Use:

For use when normothermic fluid is indicated.

Description:

The Thermal Angel is an in-line, battery-powered disposable, lightweight and completely portable blood
and IV fluid infusion warming device, capable of intravenous application and irrigation warming. The
Thermal Angel can be used to help prevent fluid-induced hypothermia. The Thermal Angel TA-200 will
strive to achieve 38°C (100.4°F) ±3°C at a flow rate of 2 to 150 ml/min given a fluid input temperature of
20°C (68°F) with a fully charged TA-BCE Battery.

With changes in flow rate or input fluid temperature, the Thermal Angel TA-200 will require an
adjustment period of approximately 15-30 seconds. An internal sensor measures temperature at a rate
of approximately 5000 times per second and adjusts power to the heaters accordingly.

Gather the Following:

• Thermal Angel (TA-200)

• 9 inch IV Extension Set (TA-9EXT) or similar

• Battery (TA-BCE)

• Battery Bag (TA-CC)

• Power Cable (TA-CDC)

• Battery Charger (TA-CAC)

• IV Administration Set (end user provided)

• Fluid (end user provided)

Preparation of Battery:

The Thermal Angel TA-200 is powered by a fully charged reusable Battery (TA-BCE). The Battery is
charged by the Battery Charger (TA-CAC) which requires 120 Volts AC. When not in use, the Battery
should remain connected to the Battery Charger to maintain the optimum charge level.

Estill Medical Technologies, Inc.

4144 N. Central Expwy. Suite 260 Dallas, Texas 75204

100-0010-131; Rev E

[phone] Fax: [phone] Toll Free: [phone] www.thermalangel.com

Step 1:

• Plug Battery into Battery Charger.

• Plug Battery Charger into AC electrical outlet.

• Allow Battery to charge for 14 hours if fully discharged.

Step 2:

• Verify charge status of Battery by pressing red button on
Battery.

• Green LED indicates a full charge.

• Yellow LED indicates a moderate charge.

• Red LED indicates an insufficient charge.

!

Important:

The LED indicators on the Battery are designed to display the charge condition when the Battery is not
being charged and not being used to power the Thermal Angel. A false indication may be displayed
during Battery charging or Thermal Angel operation. Check the charge status of the Battery when
disconnected from the Battery Charger and Thermal Angel.

Charging the Battery and powering the Thermal Angel are two separate operations. Do not charge the
Battery while the Thermal Angel is in operation.

The Battery should be fully charged prior to first use. The Battery should be recharged after each use.
The Battery does not have a memory effect and may be recharged even though it has not been fully
discharged.

The Battery has a life expectancy of about 150 charge cycles.
With a fluid input temperature of 20°C (68°F), a fully charged TA-BCE Battery will last through

approximately 2 to 4 liters of IV fluid at various flow rates. With a fluid input temperature of 10°C (50°F),
a fully charged TA-BCE Battery will last through approximately 1 to 3 units of blood at various flow rates.

100-0010-131; Rev E

Estill Medical Technologies, Inc.

4144 N. Central Expwy. Suite 260 Dallas, Texas 75204

[phone] Fax: [phone] Toll Free: [phone] www.thermalangel.com

Preparation of the Thermal Angel TA-200:

• Visually inspect the Thermal Angel and 9 Inch IV Extension Set
to insure there is no damage to the packaging or unit.

• Use aseptic technique to open the Thermal Angel and 9 Inch IV
Extension Set.

Step 1:

• Remove the female luer cap from the inlet end of the Thermal
Angel.

• Connect IV tubing to the female luer. Tighten until resistance is
met. Do not over tighten!

Step 2:

• Remove the male luer cap from the outlet end of the Thermal
Angel.

• Connect 9 Inch IV Extension Set to the male luer. Tighten until
resistance is met. Do not over tighten!

100-0010-131; Rev E

Estill Medical Technologies, Inc.

4144 N. Central Expwy. Suite 260 Dallas, Texas 75204

[phone] Fax: [phone] Toll Free: [phone] www.thermalangel.com

Step 3:

• Connect assembled IV line to fluid source and prime the line.

Step 4:

• Connect the male end of the Power Cable to the inlet end cap
of the Thermal Angel.

• Connect the female end of the Power Cable to the Battery.

• The green LED on the Thermal Angel inlet end cap should

display continuous illumination without blinking.

Step 5:

• Connect 9 Inch IV Extension Set to IV catheter.

• Engage roller clamp on IV tubing to adjust flow.

Estill Medical Technologies, Inc.

4144 N. Central Expwy. Suite 260 Dallas, Texas 75204

100-0010-131; Rev E

[phone] Fax: [phone] Toll Free: [phone] www.thermalangel.com

Blood Infusion:

Always use with approved blood administration set. When infusing blood through the Thermal Angel TA­200, follow the instructions provided with the blood administration set. The Thermal Angel TA-200 is
intended to function as an extension of the IV tubing. Replace the Thermal Angel TA-200 when replacing
the blood administration set. Refer to your facility/organization protocol.

Adverse events should be handled by discontinuing the use of the Thermal Angel TA-200 and
immediately notifying the manufacturer or manufacturer’s representative.

In circumstances where instructions are unclear about chan ging the blood administration set, replace the
Thermal Angel TA-200 after infusion of two units of blood.

Specifications and Characteristics:

The Thermal Angel TA-200 is a single use item. When necessary, cleaning should consist of wiping the
external covering of the unit with a damp cloth. Do not submerge, sterilize or autoclave the Thermal
Angel TA-200.

The Thermal Angel TA-200 will strive to achieve 38°C (100.4°F) ±3°C at a flow rate of 2 to 150 ml/min
given a fluid input temperature of 20°C (68°F) with a fully charged TA-BCE Battery. This temperature is
set by the manufacturer and may not be altered.

With changes in flow rate or input fluid temperature, the Thermal Angel TA-200 will require an
adjustment period of approximately 15-30 seconds. The Thermal Angel TA-200 is designed to operate
with flow rates of 2 to 150 ml/min. Operation beyond the design specifications will result in lower output
temperature.

The Thermal Angel TA-200 is compatible with any existing IV administration set that utilizes standard luer
connections.

Incoming fluid temperature must be between 4°C (39.2°F) and 38°C (100.4°F).
The Thermal Angel TA-200 requires a fully charged TA-BCE Battery.

Thermal Angel TA-200 Device Life Expectancy:

The Thermal Angel TA-200 may be left in-line until the IV site or line is changed, up to 72 hours. The
Thermal Angel TA-200 will perform for approximately 72 hours of accumulated use while receiving power
from multiple fully charged Batteries. After approximately 72 accumulated hours of use, the Thermal
Angel TA-200 will continue to operate until power is removed; however, it will not power up again and
should be discarded. Dispose of the Thermal Angel TA-200 using biohazard precautions.

If the incoming fluid temperature exceeds 47°C (116.6°F) and the power is connected, the failsafe circuit
will be activated. Activation of the failsafe circuit will result in permanent operational termination.

The Battery, Battery Bag, Battery Charger and Power Cable are reusable.

Estill Medical Technologies, Inc.

4144 N. Central Expwy. Suite 260 Dallas, Texas 75204

100-0010-131; Rev E

[phone] Fax: [phone] Toll Free: [phone] www.thermalangel.com

!

Caution!

Entry into the product housing is not authorized and should not be attempted. Any attempt to gain entry
into the internal components of the Thermal Angel will void any warranty claims. Unlawful entry into the
product housing can lead to product malfunction.

Use of the Thermal Angel TA-200 inconsistent with its instructions may result in failure of the device.
Discontinue use if the green LED is off or blinking.
Store the Thermal Angel TA-200 at temperatures between 0°C (32°F) and 40°C (104°F). Exceeding

these limits may cause the device to malfunction.
Testing has not yet determined maximum shelf life.
The Thermal Angel TA-200 has not been evaluated within the confines of a MRI.

Troubleshooting:
Problem Cause Solution
No power or green LED

not illuminated on inlet
end cap

Power Cable not secure to Battery
and/or Thermal Angel

Inadequate Battery charge Charge Battery
Thermal Angel, Battery or Power

Secure connections

Replace

Cable malfunction

Blinking green LED on
inlet end of cap

Thermal Angel malfunction Disconnect Power Cable and

reconnect. If LED continues to blink,
replace Thermal Angel.

Fluid input temperature too low or too
high

Verify fluid input temperature is
between 4°C (39.2°F) and 38°C
(100.4°F)

No flow

Roller clamp or stopcock closed Open as desired
Kink in IV line Straighten or replace IV line

Warranty Information:

The Thermal Angel TA-200 is warranted to be free from manufacturer defect and is covered for one year
from the date of purchase.

Patent:

Assembled by OPTO CIRCUITS INDIA LTD. under U.S. Patent Nos. 6,142,974 & 6,139,528 (other
patents pending) for:

Estill Medical Technologies, Inc.

4144 N Central Expressway, Suite 260

Dallas, TX 75204

Toll Free: [phone]

Web: www.thermalangel.com

100-0010-131; Rev E

Estill Medical Technologies, Inc.

4144 N. Central Expwy. Suite 260 Dallas, Texas 75204

[phone] Fax: [phone] Toll Free: [phone] www.thermalangel.com