The set point temperature ranges between 30°C -40°C. This is the operational range determined by MTRE^TM. It is built into the system`s algorithm with the knowledge that it will provide a suitable answer for most clinical requirements. Cardiologists who target temperature as low as 18°C-28°C, reach this goal only with the aid of an extra-corporal device such as CPB. Technically, however, the Allon device is capable of reaching lower water temperatures than its set-point. Practically speaking, the Allon® System DOES NOT heat or cool. It controls, maintains and displays patient`s temperature at any desired set point required by the physician.

There is no minimum or maximum time for using the Allon® System. It depends entirely on the requirements of the specific surgical or other medical procedure. It can be used for a very short procedure or for an indefinite length of time. The ThermoWrap® has a limitation of 28 hours and should be replaced accordingly.

The algorithm of the Allon® system is based mainly on the input from the core temperature sensor, which is the essential input for the machine`s operation. The surface temperature input is for fine-tuning only.

The core temperature sensor can be placed according to the physician`s decision: rectum, esophagus, nasopharynx or bladder. There could be differences in temperature readings ranging from 0.5°C-1°C among these locations. However the physician takes these differences into consideration. The Allon system will function well with a temperature reading from any steady continuous location. Different procedures require careful attention when choosing the sensor location. For example, for surgery in the area of the perineum, such as extensive prostatectomy, it is recommended to avoid rectal sensoring. In cardiovascular surgery, placing the sensor in the esophagus can give false results due to the temperature of the blood injected from the heart and lung machine. In any case, the physician should decide on the sensor location.

Reusable sensors should be treated like any other reusable items according to local Operating Room protocol. Disposable sensors should be used according to the Allon® specifications.

Reusable sensors should be treated like any other reusable items according to local Operating Room protocol. Disposable sensors should be used according to the Allon® specifications.

This is what the Allon® system is all about, being able to be accurate and as close as possible to the desired temperature, certainly within the limits of the physics and physiology. In most cases, the deviation from the desired temperature is no more that 0.5°C.

The FDA and CE have cleared the Allon® System for use in any medical application. It has already proven itself in burn cases.

The cardiac ThermoWrap® was designed after thorough research and consultation with cardio-thoracic surgeons around the world. To the best of our knowledge and based upon our experience, in open-heart surgeries the garment interferes in no way with the procedure.

The ThermoWrap® is placed on the patient before creating the sterilized field. Even if it were sterilized it would not remain sterile after wrapping the body. By definition, the ThermoWrap® is out of the sterile field during the procedure. The ThermoWrap® is not sterilized but is clean by all international standards for clean cloth in the OR.

This is a very important question that was addressed during the planning, development and designing stages of the ThermoWrap®. Medical staffs are very well aware of the risk that may be inflicted to the patient when using scrub preparations, especially when using them excessively. Chemical burns are well documented in medical literature. Therefore, it is vital to prevent by all means alcohol preparations from penetrating between patient and ThermoWrap®. This applies to any procedure being carried out in an operating room, whether or not a ThermoWrap® is being used.

MTRE^TM addressed this issue during the development process of the system. In order to prevent these, a specially designed "bubble trapper" has been incorporated to the Allon® system which prevents uneven warming due to air bubbles.

No, the ThermoWrap® is disposable and should be replaced if damaged.

The ThermoWrap® is disposable and is not meant to be reused for the following reasons:
A used TW remains dirty and cannot be cleaned.
It has limited use (28 hours) after which it may start leaking.
A possible attempt to clean it may result in a damaged product, for which MTRE^TM can not be held responsible.

The ThermoWrap® has been tested for pressure of over 2 bars when normal pressure in garment is 0.4bar (and maximum pressure is 0.8 bar when the machine is shut down). The alarm will go on when major leakage occurs and water level reaches a certain minimum level in the water tank. A similar alarm will go on when core sensor is accidentally pulled out.
(Note: during surgery, a sterilized sheet that serves as an additional protection covers the TW. In this case, if a leak occurs, the water will be absorbed into the sheet in such manner that it will not compromise the sterile field (We found that there is no need for an alarm in this situation).

After wrapping the patient with the ThermoWrap®, additional drapes cover the patient and the ThermoWrap®. This way, if water leaks for some reason, it will be contained by the drapes and will not spread to the sterile field of operation.

This is an undesirable situation since the combination of fluid, heat and diathermia can be a problem in the OR. Despite the effort to leave the patient dry after prepping, it is possible that fluid/alcohol will seep between the ThermoWrap® and the patient. These liquids can raise the risk of skin injury during operations. MTRE`s instruction is to place an absorbent cloth when prepping the patient. Furthermore, it is important to emphasize the need to wipe those residual fluids to reduce such a risk. (See answer #12)

Regular tap water will do just fine for the following reasons:
a) A pre-measured amount of chlorine tablets is added to each ThermoWrap to prevent formation and growth in the water reservoir. The water that flows from the ThermoWrap into the Allon device carries chlorine with it into the reservoir.
b) The system contains a micron filter that prevents contamination.

The Allon® system complies with international standards for safety and EMC.
IEC 601-1-Electrical safety for medical devices
IEC 601-1-2 EMC for medical devices.

The Allon® system is designed to target a wide range of surgical procedures mainly for the goal of achieving and maintaining normothermia, but also for induced hypothermia and precise re-warming.

A few demos have been conducted with a cardiac ThermoWrap®, but the use has been cumbersome and has required a high level of cooperation from the OR staff. Presently, MTRE is designing a ThermoWrap® for lateral positions. Until development is completed, this type of wrapping is not recommended.

The Allon® device offers a graphical display of the core sensor in response to medical request. Until now, there have been no requests for surface temperature graphical display .
It is available only by means of data logging through the RS232 outlet, placed on the Allon® rear panel.