The reported event was inconclusive.The root cause of the reported issue could not be determined.The device was not returned to the facility's biomed for evaluation.Per troubleshooting, it was found that the temp cable was in the temp out port instead of patient temp 1 port.After plugging the temp cable into the correct port, the temperature was still not reading.Therefore, the nurse swapped out temp cables but the device would not read the second cable either.A potential root cause could be the temp cables were failing, however, since the device was not returned, this could not be confirmed.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: " introduction: the effect of temperature variations on the human body has been well documented.Elevated temperatures may be harmful to the brain under normal conditions, and even more importantly, during periods of physical stress, such as illness or surgery.Conversely, lower body temperatures, or mild hypothermia, may offer some degree of neuroprotection.Moderate to profound hypothermia (below 32ºc) tends to be more harmful to the body and may lead to death.Temperature management or thermoregulation can be viewed in two different ways.The first aspect of temperature management includes treating abnormal body temperatures, i.E.Cooling the body from elevated temperatures (hyperthermia), or warming the body to manage hypothermia.The second aspect of thermoregulation is an evolving treatment that employs techniques that physically control a patient¿s temperature to provide a physiological benefit, such as cooling for a degree of neuroprotection hypothermia may occur for a variety of reasons, including exposure to cold environments, trauma, or long complex surgical procedures.Hyperthermia may occur as a result of systemic inflammatory response, sepsis, stroke, or other brain injury.While the mechanism of the effect of the hyperthermia on the brain is not clearly understood, there is evidence to indicate that even mild increases in temperature may contribute to neurological deficits.The medivance arctic sun temperature management system has been designed to regulate body temperature for those patients who require procedures requiring therapeutic temperature management and/or to assist in controlling temperature for specific medical or surgical conditions.Caution: this product is to be used by or under the supervision of trained, qualified medical personnel.Environmental conditions: the arctic sun model 2000 should be stored and used in specific operating conditions: operating temperature range: 10ºc to 27ºc (50ºf to 80ºf) storage temperature range: -30ºc to 50ºc (-20ºf to 120ºf) at operating temperatures higher than 27ºc (80ºf), the refrigeration system¿s cooling capacity and therefore its ability to cool a patient is compromised.If the control module is to be exposed to subfreezing temperatures, refer to the service manual for special draining procedures.Ambient humidity range: operating: 5% to 70% relative humidity, non-condensing storage: 5% to 95% relative humidity, non-condensing indications for use: the arctic sun temperature management system is intended for monitoring and controlling patient temperature within a range of 32°c to 38.5°c (89.6ºf to 101.3ºf).The indications for use include any condition where patient temperature control within a range covering mild hypothermia to normothermia is required.This would include, but not limited to, medical, surgical, febrile, accidental hypothermia, or heat stroke patients.Caution: federal law (usa) restricts this device to sale by or on the order of a physician.Contraindications for use: there are no known contraindications for the use of a thermoregulatory system.Do not place arcticgel pads¿ on skin that has signs of ulceration, burns, hives, or rash.While there are no known allergies to hydrogel materials, caution should be exercised with any patient who has a history of skin allergies or sensitivities.Warnings and cautions: warnings- do not use the arctic sun® temperature management system in the presence of flammable agents because an explosion and/or fire may result.Do not use high frequency surgical instruments or endocardial catheters while the arctic sun® temperature management system is in use.There is a risk of electrical shock and hazardous moving parts.There are no user serviceable parts inside.Do not remove covers.Refer servicing to qualified personnel.Power cord has a hospital grade plug.Grounding reliability can only be achieved when connected to an equivalent receptacle marked ¿hospital use¿ or ¿hospital grade¿.When using the arctic sun® temperature management system, note that all other thermal conductive systems, such as water blankets and water gels, in use while warming or cooling with the arctic sun® temperature management system may actually alter or interfere with patient temperature control.Do not place arcticgel¿ pads over transdermal medication patches as warming can increase drug delivery, resulting in possible harm to the patient.Cautions: this product is to be used by or under the supervision of trained, qualified medical personnel.Federal law (usa) restricts this device to sale, by or on the order of a physician.Use only distilled or sterile water.The use of other fluids will damage the arctic sun® temperature management system.When moving the arctic sun® temperature management system always use the handle to lift the controller over an obstacle to avoid over balancing.The patient bed surface should be located between 30 and 60 inches (75 cm and 150 cm) above the floor to ensure proper flow and minimize risk of leaks.The clinician is responsible to determine the appropriateness of custom parameters.When the system is powered off, all changes to parameters will revert to the default unless the new settings have been saved as new defaults in the advanced setup screen.For small patients (=30 kg) it is recommended to use the following settings: water temperature high limit =40°c (104°f); water temperature low limit =10°c (50 °f); control strategy =2.The operator must continuously monitor patient temperature when using manual control and adjust the temperature of the water flowing through the pads accordingly.Patient temperature will not be controlled by the arctic sun® temperature management system in manual control.Due to the systems high efficiency, manual control is not recommended for long duration use.The operator is advised to use the automatic therapy modes (e.G.Control patient, cool patient, rewarm patient) for automatic patient temperature monitoring and control.The arctic sun® temperature management system will monitor and control patient core temperature based on the temperature probe attached to the system.The clinician is responsible for correctly placing the temperature probe and verifying the accuracy and placement of the patient probe at the start of the procedure.Medivance supplies temperature simulators (fixed value resistors) for testing, training and demonstration purposes.Never use this device, or other method, to circumvent the normal patient temperature feedback control when the system is connected to the patient.Doing so exposes the patient to the hazards associated with severe hypo- or hyper-thermia.Medivance recommends measuring patient temperature from a second site to verify patient temperature.Medivance recommends the use of a second patient temperature probe connected to the arctic sun® temperature management system temperature 2 input as it provides continuous monitoring and safety alarm features.Alternatively, patient temperature may be verified periodically with independent instrumentation.The displayed temperature graph is for general information purposes only and is not intended to replace standard medical record documentation for use in therapy decisions.Patient temperature will not be controlled and alarms are not enabled in stop mode.Patient temperature may increase or decrease with the arctic sun® temperature management system in stop mode.Carefully observe the system for air leaks before and during use.If the pads fail to prime or a significant continuous air leak is observed in the pad return line, check connections.If needed, replace the leaking pad.Leakage may result in lower flow rates and potentially decrease the performance of the system.The arctic sun® temperature management system is for use only with the arcticgel¿ pads.The arcticgel¿ pads are only for use with the arctic sun® temperature management systems.The arcticgel¿ pads are non-sterile for single patient use.Do not reprocess or sterilize.If used in a sterile environment, pads should be placed according to the physician request, either prior to the sterile preparation or sterile draping.Arcticgel¿ pads should not be placed on a sterile field.Use pads immediately after opening.Do not store pads once the kit has been opened.Do not place arcticgel¿ pads on skin that has signs of ulceration, burns, hives, or rash.While there are no known allergies to hydrogel materials, caution should be exercised with any patient who has a history of skin allergies or sensitivities.Do not allow circulating water to contaminate the sterile field when patient lines are disconnected.The water content of the hydrogel affects the pad adhesion to the skin and conductivity, and therefore, the efficiency of controlling patient temperature.Periodically check that pads remain moist and adherent.Replace pads when the hydrogel no longer uniformly adheres to the skin.Replacing pads at least every 5 days is recommended.Do not puncture the arcticgel¿ pads with sharp objects.Punctures will result in air entering the fluid pathway and may reduce performance.If accessible, examine the patient skin under the arcticgel¿ pads often, especially those at higher risk of skin injury.Skin injury may occur as a cumulative result of pressure, time and temperature.Do not place bean bag or other firm positioning devices under the arcticgel¿ pads.Do not place positioning devices under the pad manifolds or patient lines.The rate of temperature change and potentially the final achievable patient temperature is affected by many factors.Treatment application, monitoring and results are the responsibility of the attending physician.If the patient does not reach target temperature in a reasonable time or the patient is not able to be maintained at the target temperature, the skin may be exposed to low or high water temperatures for an extended period of time which may increase the risk for skin injury.Ensure that pad sizing / coverage and custom parameter settings are correct for the patient and treatment goals, water flow is greater than or equal to 2.3 liters per minute and the patient temperature probe is in the correct place.For patient cooling, ensure environmental factors such as excessively hot rooms, heat lamps, and heated nebulizers are eliminated and patient shivering is controlled.Otherwise, consider increasing minimum water temperature, modifying target temperature to an attainable setting or discontinuing treatment.For patient warming, consider decreasing maximum water temperature, modifying target temperature to an attainable setting or discontinuing treatment.Due to underlying medical or physiological conditions, some patients are more susceptible to skin damage from pressure and heat or cold.Patients at risk include those with poor tissue perfusion or poor skin integrity due to diabetes, peripheral vascular disease, poor nutritional status, steroid use or high dose vasopressor therapy.If warranted, use pressure relieving or pressure reducing devices under the patient to protect from skin injury.Do not allow urine, antibacterial solutions or other agents to pool underneath the arcticgel¿ pads.Urine and antibacterial agents can absorb into the pad hydrogel and cause chemical injury and loss of pad adhesion.Replace pads immediately if these fluids come into contact with the hydrogel.Do not place arcticgel¿ pads over an electrosurgical grounding pad.The combination of heat sources may result in skin burns.If needed, place defibrillation pads between the arcticgel¿ pads and the patient¿s skin.Carefully remove arcticgel¿ pads from the patient¿s skin at the completion of use.Discard used arcticgel¿ pads in accordance with hospital procedures for medical waste.The usb data port is to be used only with a standalone usb flash drive.Do not connect to another mains powered device during patient treatment.Users should not use cleaning or decontamination methods different from those recommended by the manufacturer without first checking with the manufacturer that the proposed methods will not damage the equipment.Do not use bleach (sodium hypochlorite) as it may damage the system.Medivance will not be responsible for patient safety or equipment performance if the procedures to operate, maintain, modify or service the medivance arctic sun® temperature management system are other than those specified by medivance.Anyone performing the procedures must be appropriately trained and qualified.12199, 2917 = "nl".
|