Arctic Sun 2000 Operators Manual Rev P

contents Preface... iv Customer Information and Technical Support... v Section One 1.1 Introduction... 6 1.2 Symbols and Standards... 7 1.3 Environmental Conditions... 9 1.4 Indications for Use... 9 1.5 Contraindications for Use... 10 1.6 Warnings... 10 1.7 Cautions... 11 Section Two 2.1 System Description... 16 2.2 Model 2000 Components... 18 2.3 Remote Display and Controls... 20 2.4 Fluid Delivery Line... 24 2.5 Patient Temperature Cables and Probes... 24 2.6 Temperature Out... 25 2.7 ArcticGel Pads... 26 Section Three 3.1 Initial Setup... 28 3.2 Filling the Control Module... 28 3.3 Location of the Patient... 30 3.4 Draining the Control Module... 31 3.5 Cleaning and Maintenance... 31

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Arctic Sun 2000 Operator’s Manual 3.6 Service and Calibration... 34 3.7 Warranty... 35 Section Four 4.1 Beginning a Procedure... 36 4.2 Setting Custom Parameters... 36 4.3 Collecting Data... 40 4.4 Pre-warming or Pre-cooling the Model 2000... 41 4.5 Placing the ArcticGel Pads... 42 4.6 Connecting the Pads to the Fluid Delivery Lines... 47 4.7 Pad Weights... 48 4.8 Treating a Patient Using Automatic Mode... 49 4.9 Treating a Patient Using Manual Mode... 53 4.10 Water Flow Rate... 55 4.11 Interrupting Treatment for Patient Transport... 56 4.12 Ending a Procedure... 56 Section Five 5.1 Alarms... 58 5.2 Alerts... 60 5.2 Troubleshooting the Arctic Sun System... 60 Appendices A. Installation Procedure... 66 B. Alarms/Alerts Description & Specifications... 68 C. Alarm/Alerts List and Actions to Correct... 70 D. Specifications... 81 E. Data Collection... 83

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preface This Operator’s Manual provides a detailed discussion of the Arctic Sun Temperature Management System from Medivance, Inc., its components, and relevant accessories. The Arctic Sun System provides a safe and effective way of modifying patient temperature, providing precise temperature control in a novel approach. The Arctic Sun Model 2000 is equipped with numerous safety and control features, such as temperature and system alarms and alerts, and programmability. It is important for the operator to become familiar with the operation of the system prior to use. Reading and understanding this Operator’s Manual will guide the user in the safe and effective use of the system. This manual is associated with software version 4.xx. The version of software installed in each Model 2000 is displayed on the Remote Display’s custom menu display at power up. Features may differ with other versions.

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Customer Information Technical Support

Medivance hours of operation are 8 am to 5 pm Mountain Standard Time. Emergency support is offered after hours by calling 303-926-1917 or 877-267-2314. Additional educational materials, such as training programs for in-house staff, operator manuals, quick reference guides, and a bibliography of relevant materials are available to all Medivance Customers. Prior to using the Arctic Sun, a Medivance representative will provide on-site in-services to ensure adequate training has occurred. Additional requests for technical support, information or orders may be placed by mail, fax, or by calling Medivance Customer Service: Model No.

Arctic Sun Model 2000

Phone:

Toll free (877) 267-2314

Fax:

(720) 880-5400

Address:

321 South Taylor Ave., Suite 200 Louisville, CO 80027

E-mail:

[email protected]

Internet:

www.medivance.com

European Representative: Medivance EU BV

0050

President Kennedylaan 19 2517 JK ‘S-Gravenhage The Netherlands

EC

REP v

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section 1.1 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.1 Moderate to profound hypothermia (below 32ºC) tends to be more harmful to the body and may lead to death.2 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

Schwab S, Schwartz S, Spranger M, et al. Moderate Hypothermia in the Treatment of Patients with Severe Middle Cerebral Artery Infarction. Stroke 1998; 29 (12): 2461-6 1

Guyton A, Hall J. Textbook of Medical Physiology, Ninth Ed (Philadelphia, PA: W.B. Saunders, 1996): 119

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 neuroprotection3,4.

2

Ginsberg M, Sternau L, et al. Therapeutic Modulation of Brain Temperature: Relevance to Ischemic Brain Injury. Cerebrovascular Brain Metabolism Review 1992; 4 (3): 189- 225 3

4 Corbett D,; Thornhill J. Temperature Modulation (Hypothermic and Hyperthermic Conditions) and its Influence on Histological and Behavioral Outcomes Following Cerebral Ischemia. Brain Pathology 2000; 10(1): 145-52. 5 Sessler DI. Perioperative Heat Balance. Anesthesiology 2000; 92: 578-96

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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.5 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.

Arctic Sun 2000 Operator’s Manual

1.2 Symbols and Standards The Arctic Sun Model 2000 bears the following symbols: For the safe and effective use of this device, the operator must consult the accompanying documents prior to use. EC REP

Identifies European Representative. This symbol adjacent to the patient connections means that the thermal probe connection is a “Defibrillator-Proof, Type BF Applied Part”, per standard IEC 60601-1 and affords the degree of patient protection defined in that standard for this type of applied part. Models of the Arctic Sun that bear the Entela US/C Monogram have been Certified for Safety by Entela, Inc. against standards C22.2, No. 601.1 and UL 2601. Identifies the equipotential terminal on the equipment, which is intended to be connected with the equipotential terminal(s) on one or more other types of equipment in close proximity, in order to bring all pieces of equipment to the same potential for safety purposes. Indicates high temperature part or component.

Indicates that only sterile or distilled water should be used when filling the Arctic Sun Control Module.

Identifies Patient Temperature 1, the patient temperature probe input for monitoring and control.

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Identifies Patient Temperature 2, the patient temperature probe input for monitoring.

Identifies the drain port.

Identifies the storage temperature range.

Identifies the storage relative humidity range.

Indicates electrical hazard

Indicates Earth Ground

Identifies the heater fuse. The Arctic Sun Control Module meets both the electromagnetic interference and susceptibility requirements of IEC 601-1, and is compatible with other equipment that also conforms to that standard. There is no known failure mode in the Arctic Sun Control Module associated with electromagnetic interference from other devices.

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Arctic Sun 2000 Operator’s Manual

1.3 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

1.4 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. 9

1.5 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.

1.6 Warnings

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• Do not use the Arctic Sun in the presence of flammable agents because an explosion and/or fire may result. • 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, note that all other thermal conductive systems, such as water blankets and water gels, in use while warming or cooling with the Arctic Sun may actually alter or interfere with patient temperature control.

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Arctic Sun 2000 Operator’s Manual

1.7 Cautions

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• 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 Model 2000. • The patient’s 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 operator 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. • The operator must continuously monitor patient temperature in Manual Mode. Patient temperature will not be controlled by the Arctic Sun in Manual Mode. • The Arctic Sun will monitor and control patient core temperature based on the temperature probe attached to the system. Medivance recommends measuring patient temperature from a second site to verify patient temperature. • It is the sole responsibility of the clinician or operator to monitor patient temperature during Manual Mode and to adjust the temperature of the water flowing through the pads accordingly. • Due to the system’s high efficiency, Manual Mode is not recommended for non-surgical treatments that require cooling.

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• Patient temperature will not be controlled and alarms are not enabled in Stop Mode. Patient temperature may increase or decrease with the Arctic Sun in Stop Mode. • It is advisable not to cancel the alarm or alert until the situation is resolved. If an alarm is cancelled and the condition has not been corrected, the alarm will recur. If an alert is cancelled and the alert condition has not been corrected, the alert will not recur unless the Stop Mode is activated. • Carefully observe the system for air leaks in the system 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 Model 2000 is for use only with the ArcticGel Pads. • The ArcticGel Pads are only for use with an Arctic Sun Model 2000. • 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’s request, either prior to the sterile preparation or sterile draping. ArcticGel Pads should not be placed on a sterile field.

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Arctic Sun 2000 Operator’s Manual

• Use pads immediately after opening. Do not store pads once the kit has been opened. • Do not allow circulating water to contaminate the sterile field when patient lines are disconnected. • The water content of the hydrogel affects the pad’s 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’s 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

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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 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, environmental factors such as excessively hot rooms, heat lamps, and heated nebulizers are eliminated, water flow is greater than or equal to 2.3 liters per minute, a patient temperature probe is in the correct place, and patient shivering is controlled. Otherwise, consider increasing minimum 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 of skin injury. • Do not allow antibacterial agents to pool underneath the ArcticGel Pads. Excess antibacterial agents can absorb into the pad adhesive and cause chemical burns and loss of pad adhesion.

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Arctic Sun 2000 Operator’s Manual

• Do not place ArcticGel Pads over an electrosurgical grounding pad. The combination of heat sources may result in skin burns. • Carefully remove ArcticGel Pads from the patient’s skin at the completion of use. • Any device connected to the RS232 data port must comply with the applicable IEC standard for that device. • 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. • Medivance will not be responsible for patient safety or equipment performance if the procedures to operate, maintain, modify or service the Medivance Arctic Sun are other than those specified by Medivance. Anyone performing the procedures must be appropriately trained and qualified.

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2

section 2.1 System Description The Arctic Sun Temperature Management System is a thermoregulatory device that monitors and controls patient temperature within a range of 32°C to 38.5°C (89.6°F to 101.3°F). The Arctic Sun System consists of the Model 2000 and disposable ArcticGel Pads. The Model 2000 consists of the Control Module, Remote Display, Fluid Delivery Line, cables and accessories. The Model 2000 pulls temperature-controlled water ranging between 4°C and 42°C (39.2°F and 107.6°F) through the ArcticGel Pads at approximately 0.7 liter per minute per pad. This results in heat exchange between the water and the patient. Unlike conventional water based systems, this system operates under negative pressure relative to ambient. Any break or leak in the system will result in air entering the circuit instead of water leaking out.

Figure 1 The Remote Display can be stored in its parking spot on the Control Module when not in use. Figure 2 (right) When in use, the display is attached to the upright handle for easy visibility.

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The system functions in either an Automatic Mode or Manual Mode. In Automatic Mode, a patient temperature probe, connected to the Control Module, provides feedback to an internal control algorithm. The temperature of the water increases or decreases automatically to achieve a pre-set patient target temperature determined by the clinician. In Manual Mode, the feedback control algorithm is not activated. The operator adjusts the temperature of the water delivered to the pads directly and is responsible for monitoring patient temperature.

Arctic Sun 2000 Operator’s Manual

The Arctic Sun Control Module must be used only with the ArcticGel Pads. The pads are thin, and anatomically shaped to cover areas of the patient’s skin. They come in non-sterile kits in sizes to cover a broad range of patients, fit both males and females, and are for single patient use only. Each pad has an inlet and an outlet connection that attaches to a Fluid Delivery Line. Up to six pads can be connected at one time. The pads are designed so that water flows within internal pathways across its surface to provide even, efficient heat transfer between the skin and water. The pads adhere to the patient’s skin by the use of a biocompatible compatible hydrogel adhesive. The hydrogel maintains its adhesion level over extended periods. The pads can be repositioned on the patient’s skin if needed. The back of each pad is insulated to minimize heat transfer to the environment and condensation when cooling. The Arctic Sun Model 2000 is a CLASS I (Type BF, IPX0 and Mode of Operation - Continuous) portable device per classification scheme of IEC 601-1.

! CAUTION: The Arctic Sun Model 2000 is for use only with the ArcticGel Pads. The Arctic Sun Control Module can be placed in various locations in the intensive care unit or operating room while being controlled from the Remote Display. The Control Module has a four wheel independent locks. Its handle can be raised and locked for transport or placed in the down position for storage. (See figure 1 and 2) Do not lift the Control Module by the handle.

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2.2 Model 2000 Components The Fluid Delivery Lines, Patient Temperature Cables, Temperature Out Cable, Remote Display Cable, and the Power Cord are connected to the rear of the Arctic Sun Control Module (See Figure 3), find lengths of tubes and cables in Table 1.

Table 1 Accessory

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Length

Remote Display Cable

42 inches 1.1 meters

Power Cord

15 feet

4.6 meters

Fluid Delivery Line

10 feet

3.0 meters

Patient Temperature Cable

10 feet

3.0 meters

Temperature Out Cable

5 inches

13 centimeters

Fill/Drain Tube

24’’

0.6 meters

Arctic Sun 2000 Operator’s Manual

Remote Display Fluid Delivery Line Storage Latch Handle Remote Display Connector Fill Port Power Switch Fluid Delivery Line & Connection Power Cord Connection Data Collection Connector – RS232 Equipotential Grounding Stud Reserved for Future Use Heater Fuse Fill/Drain Tube Strain Relief Mount Patient Temperature 1 Connector Power Cord Storage Patient Temperature 2 Connector Temperature Out Connector Drain Ports

Figure 3

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2.3 Remote Display and Controls The Arctic Sun Model 2000 is operated from the Remote Display (Figure 4). The display is clamped to the Control Module handle. The Remote Display is connected to the Control Module by a 42 inch (1.1 meter) Remote Display Cable. Modes of Operation There are four principle modes of operation. These can be accessed by pressing any of the four keys on the lower right side of the display: Automatic, Manual, Purge, and Stop. Each key represents a unique function: Automatic Mode The Automatic Mode only operates when an appropriate patient temperature probe is placed and connected to the Control Module. The Arctic Sun will adjust the temperature of the water flowing through the ArcticGel Pads to achieve a preset patient target temperature. The maximum and minimum water temperatures allowed during this mode can also be set by the user. Patient target temperature and water temperature limit settings can only be changed by returning to Stop Mode and accessing the custom menu with the down or up arrows. Note: If a patient temperature probe is not attached to the Patient Temperature 1 Connector, the display will alarm and return to Stop Mode.

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Figure 4