OPERATOR’S MANUAL d e s a e l e R OPERATOR’S MANUAL Languages The 24/7 Helpline is intended to assist healthcare professionals English ................................................................................................................................1 with technical questions they Český (Czech) ..................................................................................................................15 may have regarding the use of Danske (Danish) ............................................................................................................29 the Arctic Sun® Temperature Deutsch (German) .........................................................................................................43 Management System.  While the Ελληνικα (Greek) .............................................................................................................59 Helpline is staffed by licensed Español (Spanish) ..........................................................................................................73 critical care nurses, they are not able to provide medical or Français (French) ...........................................................................................................89 nursing advice or to prescribe Italiano (Italian) ............................................................................................................105 treatment. Magyar (Hungarian) .....................................................................................................121 Nederlandse (Dutch) ...................................................................................................135 Norske (Norwegian) ....................................................................................................149 Polski (Polish) ................................................................................................................163 Português (Portuguese) ..............................................................................................177 Slovenčina (Slovakia) ..................................................................................................193 Suomalainen (Finnish) .................................................................................................207 Svenska (Swedish) ......................................................................................................221 Türkçe (Turkish) .............................................................................................................235 Россия (Russian) ...........................................................................................................249 d 日本語 (Japanese) .......................................................................................................263 中文简体 (Chinese - Simplified) .........................................................................277 中國傳統 (Chinese - Traditional) .....................................................................291 e 한국어 (Korean) .....................................................................................................305 s Table of Contents Chapter 1 – Getting Started ...........................................................................................1 a Indications for Use ...........................................................................................................1 Warnings and Cautions ...................................................................................................1 e System Setup ....................................................................................................................2 Chapter 2 – Patient Therapy ..........................................................................................3 Place ArcticGel™ Pads .....................................................................................................3 l Connect ArcticGel™ Pads ................................................................................................3 Temperature Probe Placement ......................................................................................3 e Patient Therapy Selection ..............................................................................................3 Therapy Screens ...............................................................................................................4 R Initiate Normothermia (Control Patient) ........................................................................4 Initiate Hypothermia (Cool Patient and Rewarm Patient) ..........................................5 End Therapy ......................................................................................................................6 Chapter 3 – Normothermia Settings .............................................................................6 Normothermia Settings ...................................................................................................6 Chapter 4 – Hypothermia Settings ................................................................................7 Hypothermia Settings ......................................................................................................7 Chapter 5 – Advanced Setup .........................................................................................7 Chapter 6 – Alarms and Alerts ......................................................................................8 Alarms ................................................................................................................................8 Main Safety Alarms .........................................................................................................8 Non-Recoverable Alarms ...............................................................................................8 Recoverable Alarms ........................................................................................................8 Alerts ..................................................................................................................................8 Chapter 7 – Maintenance and Service ........................................................................8 Cleaning and Maintenance ............................................................................................8 Software Update ..............................................................................................................9 Service ...............................................................................................................................9 Calibration ..........................................................................................................................9 Appendix A: Product Specifications ............................................................................9 Technical Description ......................................................................................................9 Environmental Conditions ................................................................................................9 Arctic Sun® Temperature Management System ........................................................10 Appendix B: Symbols ...................................................................................................11 Appendix C: Electromagnetic Compatibility ...........................................................12 The current Operator’s Manual can be found at www.medivance.com/manuals. ENGLISH Chapter 1 – Getting Started 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 Indications for Use result in lower flow rates and potentially decrease the performance of the system. The Arctic Sun® Temperature Management System is intended for monitoring and controlling patient temperature. • The Arctic Sun® Temperature Management System is for use only with the ArcticGel™ Pads. Warnings and Cautions • The ArcticGel™ Pads are only for use with the Arctic Sun® Temperature Management Systems. Warnings • The ArcticGel™ Pads are non-sterile for single patient use. Do not reprocess • Do not use the Arctic Sun® Temperature Management System in the or sterilize. If used in a sterile environment, pads should be placed presence of flammable agents because an explosion and/or fire may result. according to the physician’s request, either prior to the sterile preparation • Do not use high frequency surgical instruments or endocardial catheters or sterile draping. ArcticGel™ Pads should not be placed on a sterile field. while the Arctic Sun® Temperature Management System is in use. • Use pads immediately after opening. Do not store pads once the kit has • There is a risk of electrical shock and hazardous moving parts. There are been opened. no user serviceable parts inside. Do not remove covers. Refer servicing to • Do not place ArcticGel™ Pads on skin that has signs of ulceration, burns, qualified personnel. hives, or rash. • Power cord has a hospital grade plug. Grounding reliability can only be • While there are no known allergies to hydrogel materials, caution should achieved when connected to an equivalent receptacle marked “hospital use” or “hospital grade”. be exercised with any patient who has a history of skin allergies or • When using the Arctic Sun® Temperature Management System, note that all sensitivities. other thermal conductive systems, such as water blankets and water gels, in • Do not allow circulating water to contaminate the sterile field when patient use while warming or cooling with the Arctic Sun® Temperature Management lines are disconnected. System may actually alter or interfere with patient temperature control. • The water content of the hydrogel affects the pad’s adhesion to the skin d • Do not place ArcticGel™ Pads over transdermal medication patches as and conductivity, and therefore, the efficiency of controlling patient warming can increase drug delivery, resulting in possible harm to the patient. temperature. Periodically check that pads remain moist and adherent. Replace pads when the hydrogel no longer uniformly adheres to thee skin. Cautions Replacing pads at least every 5 days is recommended. • This product is to be used by or under the supervision of trained, qualified • Do not puncture the ArcticGel™ Pads with sharp objects. Punctures will medical personnel. • Federal law (USA) restricts this device to sale, by or on the order of a result in air entering the fluid pathway and may reduce performancse. physician. • 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 • Use only distilled or sterile water. The use of other fluids will damage the Arctic Sun® Temperature Management System system. cumulative result of pressure, time and temperature. Do not place baean bag • When moving the Arctic Sun® Temperature Management System always or other firm positioning devices under the ArcticGel™ Pads. Do not place use the handle to lift the controller over an obstacle to avoid over balancing. positioning devices under the pad manifolds or patient lines. • The patient’s bed surface should be located between 30 and 60 inches (75 • The rate of temperature change and potentially the final achieveable cm and 150 cm) above the floor to ensure proper flow and minimize risk of patient temperature is affected by many factors. Treatment leaks. application, monitoring and results are the responsibility of the • The clinician is responsible to determine the appropriateness of custom attending physician. If the patient does not reach target tempelrature parameters. When the system is powered off, all changes to parameters in a reasonable time or the patient is not able to be maintained eat the will revert to the default unless the new settings have been saved as target temperature, the skin may be exposed to low or high water new defaults in the Advanced Setup screen. For small patients (≤30 kg) temperatures for an extended period of time which may increase it is recommended to use the following settings: Water Temperature the risk for skin injury. Ensure that pad sizing / coverage and custom R High Limit ≤40°C (104°F); Water Temperature Low Limit ≥10°C (64.4 °F); parameter settings are correct for the patient and treatment goals, Control Strategy =2. water flow is greater than or equal to 2.3 liters per minute and the • The operator must continuously monitor patient temperature when using patient temperature probe is in the correct place. For patient cooling, Manual Control and adjust the temperature of the water flowing through the ensure environmental factors such as excessively hot rooms, heat pads accordingly. Patient temperature will not be controlled by the Arctic lamps, and heated nebulizers are eliminated and patient shivering Sun® Temperature Management System in Manual Control. is controlled. Otherwise, consider increasing minimum water • Due to the system’s high efficiency, Manual Control is not recommended temperature, modifying target temperature to an attainable setting or for long duration use. The operator is advised to use the automatic therapy discontinuing treatment. For patient warming, consider decreasing modes (e.g. Control Patient, Cool Patient, Rewarm Patient) for automatic maximum water temperature, modifying target temperature to an patient temperature monitoring and control. attainable setting or discontinuing treatment. • The Arctic Sun® Temperature Management System will monitor and control • Due to underlying medical or physiological conditions, some patients are patient core temperature based on the temperature probe attached to the more susceptible to skin damage from pressure and heat or cold. Patients system. The clinician is responsible for correctly placing the temperature at risk include those with poor tissue perfusion or poor skin integrity due to probe and verifying the accuracy and placement of the patient probe at the diabetes, peripheral vascular disease, poor nutritional status, steroid use start of the procedure. or high dose vasopressor therapy. If warranted, use pressure relieving or • Medivance recommends measuring patient temperature from a second site pressure reducing devices under the patient to protect from skin injury. to verify patient temperature. Medivance recommends the use of a second • Do not allow urine, antibacterial solutions or other agents to pool patient temperature probe connected to the Arctic Sun® Temperature underneath the ArcticGel™ Pads. Urine and antibacterial agents can absorb Management System Temperature 2 input as it provides continuous into the pad hydrogel and cause chemical injury and loss of pad adhesion. monitoring and safety alarm features. Alternatively, patient temperature Replace pads immediately if these fluids come into contact with the may be verified periodically with independent instrumentation. hydrogel. • The displayed temperature graph is for general information purposes only • Do not place ArcticGel™ Pads over an electrosurgical grounding pad. The and is not intended to replace standard medical record documentation for combination of heat sources may result in skin burns. use in therapy decisions. • If needed, place defibrillation pads between the ArcticGel™ pads and the • Patient temperature will not be controlled and alarms are not enabled in patient’s skin. Stop Mode. Patient temperature may increase or decrease with the Arctic • Carefully remove ArcticGel™ Pads from the patient’s skin at the completion of use. Sun® Temperature Management System in Stop Mode. Discard used ArcticGel™ Pads in accordance with hospital procedures for medical • Carefully observe the system for air leaks before and during use. If the pads waste. 1 OPERATOR’S MANUAL • The USB data port is to be used only with a standalone USB flash drive. Do not Power On connect to another mains powered device during patient treatment. 1) Turn the power ON by activating the Power Switch. • Users should not use cleaning or decontamination methods different from those 2) The control module will automatically go through a brief self-test of the recommended by the manufacturer without first checking with the manufacturer that independent safety alarm. the proposed methods will not damage the equipment. Do not use bleach (sodium 3) A New User Training module option is available from the start up hypochlorite) as it may damage the system. screen. • Medivance will not be responsible for patient safety or equipment performance if the procedures to operate, maintain, modify or service the Medivance Arctic Sun® Tem- perature Management System are other than those specified by Medivance. Anyone performing the procedures must be appropriately trained and qualified. System Setup Unpack 1) Unpack the Arctic Sun® Temperature Management System Control Module and accessories. 2) Allow the control module to remain upright for at least 2 hours prior to completing the installation and setup procedure in order to allow the chiller oil to settle. Damage to the chiller compressor may result otherwise. Connections 1) Use only Medivance cables and accessories with the Arctic Sun® Temperature d Management System Control Module. Connect the Fluid Delivery Line, Patient 4) When the self-test is complete, the Patient Therapy Selection screen Temp 1 cable, Patient Temp 2 cable (optional) and Fill Tube to the back of the will appear on the control panel. control module. e 2) Plug the Power Cord into the wall outlet. Position Arctic Sun® Temperature Man- agement System so that access to the power cord is not restricted. s a e l e Patient Power Switch Temp 1 Patient Fill Reservoir R Strain Relief Temp 1) Fill the reservoir with sterile or distilled water only. Out 2) Four liters of water will be required to fill the reservoir at initial installa- Patient tion. Temp 2 3) Add one vial of Arctic Sun® Temperature Management System Cleaning Solution to the sterile or distilled water. Patient Temp Cable 4) From the Patient Therapy Selection screen, press either the Normo- thermia or Hypothermia button, under the New Patient heading. Fluid 5) From the Hypothermia or Normothermia therapy screen, press the Fill Fill Tube Delivery Reservoir button. Storage Line 6) The Fill Reservoir screen will appear. Follow the directions on the screen. Fill Tube/Port Power Cord Drain Ports Equipotential Stud Air Filter 2 ENGLISH Functional Verification Chapter 2 – Patient Therapy Perform the following functional verification procedure after initial setup and installation of the control module. Place ArcticGel™ Pads 1) Power On the control module Read the Instructions for Use that accompany the ArcticGel™ Pads. 2) From the Patient Therapy Selection screen, press the Hypothermia Examine each pad for damage prior to placement. button to display the Hypothermia therapy screen. 3) From the Hypothermia therapy screen, press the Manual Control but- Connect ArcticGel™ Pads ton to open the Manual Control window. Orient the blue and white colors on the pad line connector and Fluid 4) Use the Up and Down arrows to set the Manual Control water target Delivery Line. While holding the pad line tubing, insert the clear pad line temperature to 40°C and the duration to 30 minutes. connector into the Fluid Delivery Line manifold. Do not press or squeeze the wings when connecting. The connector will click into place. Temperature Probe Placement Patient temperature control with the Arctic Sun® Temperature Management System requires patient temperature feedback provided by an indwelling patient temperature probe connected to the Patient Temperature 1 con- nector on the back of the Control Module. Any commercially-available Yellow Springs Instrument 400 Series (YSI 400) compatible patient tempera- ture probe can be connected to the Arctic Sun® Temperature Management System. Refer to the manufacturer’s Instructions for Use for the specific indications and temperature probe placement. d 5) Press the Start button to initiate Manual Control.  Allow at least 3 minutes for the system to stabilize. Patient Therapy Selection 6) Monitor the flow rate and water temperature in the System status area Use the Patient Therapy Selection screen to initiate a New Patient, Con- e on the Hypothermia therapy screen. tinue a Current Patient, or access the Advanced Setup screen. 7) Verify that the flow rate reaches at least 1.5 liters/minute. 8) Verify that the water temperature increases to 30°C. s 9) Press the Stop button. 10) Set the Manual Control water target temperature to 4°C and the dura- tion to 30 minutes. a 11) Press the Start button to initiate Manual Control. 12) Monitor the flow rate and water temperature in the System status area of the Hypothermia therapy screen. Verify that the water temperature e drops to 6°C. 13) Press the Stop button to stop Manual Control 14) Press the Cancel button to close the Manual Control window l 15) Power Off the control module. e R New Patient - Normothermia Select Normothermia if the therapy goal is to maintain a patient tempera- ture at a pre-defined target temperature for an indefinite period of time. Press the Normothermia button to display the Normothermia therapy screen. New Patient - Hypothermia Select Hypothermia to reduce and maintain a patient temperature at a set target temperature for a defined period of time, then slowly re-warm the patient at a controlled re-warming rate. Press the Hypothermia button to display the Hypothermia therapy screen. Current Patient The Continue Current Patient button and the date and time that the current therapy was paused will display on the Patient Therapy Selection screen if a patient therapy was paused within the past 6 hours. Press the Continue Current Patient button to resume a paused patient therapy. 3 OPERATOR’S MANUAL Therapy Screens Initiate Normothermia (Control Patient) Normothermia therapy is initiated and managed, and patient temperature Normothermia Therapy Screen is automatically controlled to a set target temperature from the Control Patient window in the Normothermia therapy screen. The Control Patient C G window displays the patient target temperature and the duration since the D L initiation of normothermia therapy. P F J H M To initiate Normothermia therapy: E I N 1) From the Patient Therapy Selection screen, press the Normothermia button to display the Normothermia therapy screen. K A O Q R Hypothermia Therapy Screen C G d D L P F J H M E I N e 2) The default patient target temperature will display in the Control Pa- K tient window. s a A B O Q e R The following information is displayed and functions are available from the l Normothermia and Hypothermia therapy screens. e A Cool Patient window (Hypothermia screen) Control Patient window (Normothermia screen) R B Rewarm Patient window (Hypothermia screen) C Patient Monitoring area D Patient Temperature E Patient Temperature 2 (if enabled) 3) To modify the patient target temperature, press the Adjust button to F Patient Temperature Trend Indicator display the Control Patient-Adjust window. G System Monitoring area H Water Temperature I Water Flow Rate J Reservoir Water Level K Therapy Graph L Manual Control button (if enabled) M Empty Pads button N Fill Reservoir button O Therapy Selection / Screen Lock button P Temperature Units button (if enabled) Q Stop button R Help button 4) Control Patient To: Use the Up and Down arrows to set the desired patient target temperature to control the patient. 5) Press the Save button to save the new settings and close the Control Patient-Adjust window 6) Press Start, in the Control Patient window to initiate therapy. You will hear a tone and then a voice stating “Therapy Started”. Additionally, the Control Patient window and the Arctic Sun® Temperature Manage- ment System icon will blink, indicating that therapy is in progress. 4 ENGLISH • To modify the patient target temperature and duration, press the Adjust button to display the Cool Patient-Adjust window. • Cool Patient To: Use the Up and Down arrows on the left side to set the desired patient target temperature to cool the patient Initiate Hypothermia (Cool Patient and Rewarm Patient) • Cool Patient For: Use the Up and Down arrows on the right side to set Hypothermia therapy is initiated and managed, and patient temperature is the cooling duration to cool the patient before rewarming begins. automatically controlled to a set target temperature from the Cool Patient • Press the Save button to save the new settings and close the Cool and Rewarm Patient windows in the Hypothermia therapy screen. Patient-Adjust window The Cool Patient window displays the cooling phase patient target 2. Rewarm Patient Settings temperature and the length of time remaining in the cooling phase of the • The default patient target temperature and duration will displayd in the Hypothermia therapy. Rewarm Patient window. The Rewarm Patient window displays the rewarming phase patient target e temperature and the length of time remaining in the rewarming phase of the Hypothermia therapy. s To initiate hypothermia therapy: From the Patient Therapy Selection screen, press the Hypothermia button a to display the Hypothermia therapy screen. e l e • To change the rewarming phase patient target temperature and rewarming rate, press the Adjust button in the Rewarm PatientR window to display the Rewarm Patient-Adjust screen. Use the Up and Down ar- rows on the left side to set the desired final patient target temperature. 1. Cool Patient Settings • The default patient target temperature and duration will display in the Cool Patient window. • Rewarm Patient To: Use the Up and Down arrows on the right side to set the desired final patient target temperature. • Rewarm at a Rate of: Use the Up and Down arrows in the center of the screen to set the rewarming rate. • Rewarm Patient From: When cooling a patient, adjustment of the Rewarm Patient From setting on the left side of the screen is disabled and defaults to the Cool Patient target temperature. • When rewarming a patient, the Rewarm Patient From adjustment is enabled and the value can be modified. The Rewarm Patient From setting is the temperature to which the system is currently controlling the patient. The Rewarm Patient From temperature will automatically increase as the rewarming process continues. This feature allows the rewarming procedure to be optimized by allowing complete control of the rewarming ramp. 5 OPERATOR’S MANUAL • Using the Rewarm Patient From temperature, the Rewarm Patient To Chapter 3 – Normothermia Settings temperature and the rewarming rate settings, the system will calculate and display the rewarming duration and the date/time at which the the Normothermia Settings patient will reach the final rewarming target temperature. Use the Normothermia Settings screen to view the current settings and • Press the Save button to save the new settings and close the Rewarm modify the settings for the following parameters. To modify any parameter Patient-Adjust window. setting, press the Adjust button to the right of the parameter. 3. Initiate Patient Cooling Normothermia Settings screen parameters: • Press Start, in the Cool Patient window to initiate therapy. You will hear a tone and then a voice stating “Therapy Started”. Additionally, the Cool Therapy Settings Patient window and the Arctic Sun® Temperature Management System • Timer Begins icon will blink, indicating that therapy is in progress. Water Temperature Settings • Pre-Condition Water • Manual Control • High Water Limit • Low Water Limit Patient Temperature Settings • High Patient Alert • Low Patient Alert • Control Strategy d Display Settings • Temperature Units e • Temperature Units Adjust • Patient Temp 2 • Speaker Volume s 4. Initiate Patient Rewarming • Upon completion of the cooling phase, there are two options for initia- To access the Normothermia Settings screen: tion of patient rewarming, either Automatically or Manually, depending 1) Press Adjust on the Control Patient window. a on the Rewarming Begins setting in Hypothermia Settings. 2) Press the More button on the Control Patient Adjust window. • If Rewarming Begins is set to Automatically, the rewarming process 3) The Normothermia Settings screen will be displayed. starts automatically when the Cool Patient therapy is complete and the e duration reaches zero. • If Rewarming Begins is set to Manually, the rewarming process starts when the Start button is pressed in the Rewarm Patient window. The l cooling process will continue until the Rewarm Patient Start button is e pressed. An Alert will occur when the Cool Patient duration reaches zero. R End Therapy • From the Normothermia therapy or Hypothermia therapy screen, press the Stop button to terminate water circulation to the pads. • Press the Empty Pads button, and follow the instructions to purge the pads of water. • Disconnect the pads from the Fluid Delivery Line. • Slowly and carefully remove pads from the patient skin. • Discard the used pads in accordance with hospital procedures for 4) To save the new settings as the current patient therapy settings, press medical waste. the Close button. For instructions on saving the settings as the system • Press the power switch Off. defaults, see Advanced Setup. If power is lost while the power switch is in the On position, an audible alert will be issued until it is switched Off. This alerts the user that the treatment may have been accidentally stopped. 6 ENGLISH Chapter 4 – Hypothermia Settings Chapter 5 – Advanced Setup Hypothermia Settings Use the Advanced Setup screen to view the current settings and modify Use the Hypothermia Settings screen to view the current settings and the settings for the following parameters. To modify any parameter setting, modify the settings for the following parameters. To modify any parameter press the Adjust button to the right of the parameter. setting, press the Adjust button to the right of the parameter. Location / Time Settings Hypothermia Settings screen parameters: • Language • Number Format Therapy Settings • Current Time • Cooling Begins • Date Format • Rewarming Begins • Current Date Water Temperature Settings The following functions can be initiated from the Advanced Setup screen. • Pre-Condition Water • Download Patient Data: The Patient Data for the last 10 (ten) cases are • Manual Control stored on the Arctic Sun® Temperature Management System hard drive. • High Water Limit This data is maintained when the Arctic Sun® Temperature Management • Low Water Limit System is powered down, or in the event of a total loss of power.: • Calibration Patient Temperature Settings • Total Drain • High Patient Alert • Save All Settings As Default • Low Patient Alert d • Control Strategy Additionally, the following information can be viewed in the Advanced Setup screen. Display Settings e • Temperature Units • Software Versions • Temperature Units Adjust • Last Calibration date • Patient Temp 2 • Next calibration due s • Speaker Volume To access the Advanced Setup screen: To access the Hypothermia Settings screen: 1) Press Advanced Setup button on the Patient Therapy Selection scareen. 1) Press Adjust on the Cool Patient window or the Rewarm Patient win- 2) The Advanced Setup screen will be displayed. dow. 2) Press the More button on the Cool Patient Adjust window or Rewarm e Patient Adjust window. 3) The Hypothermia Settings screen will be displayed. l e R 4) To save the new settings as the current patient therapy settings, press the Close button. For instructions on saving the settings as the system defaults, see Advanced Setup. 7 OPERATOR’S MANUAL Recoverable Alarms Chapter 6 – Alarms and Alerts Other Alarms that temporarily Stop the device until the user is able to correct the cause and clear the Alarm are classified as Recoverable. If the The Arctic Sun® Temperature Management System safety system continu- condition that initiated the alarm is not addressed and problem persists, ally monitors the state of the device and the patient, and issues alarms or the Alarm will recur. alerts to notify the user of conditions that may interfere with patient safety or system performance. If a Recoverable Alarm occurs: 1) When an alarm is issued the device is placed into Stop mode. There are two types of conditions: Alarms and Alerts. 2) Read the displayed instructions. 3) Note the Alarm number. An Alarm notifies the user that a condition that may potentially pose an 4) Press the Close button to clear the alarm. unsafe situation with respect to the patient or the device. An Alarm is a 5) Follow the instructions to correct the alarm condition. Perform the ac- High Priority condition that requires immediate operator response. tions in the order listed until the alarm condition is resolved. 6) Once you have cleared the alarm, press the Start button in the therapy An Alert informs the user about patient and device status without interrupt- window to restart therapy. You will hear a tone and a voice stating ing the procedure. An Alert is a Medium Priority condition that requires “Therapy Started”. Additionally, the active therapy window and the prompt operator response. Arctic Sun® Temperature Management System icon will blink. 7) If the condition does not resolve, contact Medivance Customer Sup- Alarms port. An Alarm is denoted by an audio signal that repeats every 10 seconds d until the Alarm is cleared. The Alarm screen will appear that displays the Alerts alarm number, alarm title, a description of the problem or conditions that Alerts are denoted by an audio signal that repeats every 25 seconds. The triggered the alarm, and solutions and instructions for troubleshooting and Alert screen will appear that displays the alert number, alert title, a de- e resolving the alarm condition. If certain Alarm conditions are not acknowl- scription of the problem that triggered the alert, and solutions and instruc- edged by the operator within 2 minutes, a Reminder tone will sound. All tions for troubleshooting and resolving the alert condition. Alarm settings are maintained in the event of a mains power interruption. s a e l e If an Alert occurs: Main Safety Alarms 1) Read the displayed instructions. While there are multiple alarms and safety features in the Arctic Sun® Tem- 2) Note the Alert number. R perature Management System, there are five main safety alarms that will 3) Press the Close button to clear the alert. place the device into Stop mode until the condition is addressed. 4) Follow the instructions to correct the alert condition. Perform the actions in the order listed until the alarm condition is resolved. If the Alarm Specification condition does not resolve, contact Medivance Customer Support. High Patient Temperature 39.5 °C (103.1 °F) Low Patient Temperature 31.0 °C (87.8 °F) High Water Temperature 42.5 °C / 44 °C (108.5 °F / 111.2 °F) Chapter 7 – Maintenance and Service Low Water Temperature 3.0 °C / 3.5 °C (37.4 °F / 38.3 °F) System Self-Test Failure At device power ON Cleaning and Maintenance Cleaning and Maintenance Routine cleaning and preventive maintenance Each time the Arctic Sun® Temperature Management System is powered should be performed on the Arctic Sun® Temperature Management System On, a system self test for the independent safety alarm is automatically run. control module every 6 months at a minimum. This consists of cleaning This test stimulates a “water high temperature” fault situation on both the the external surfaces, accessories and chiller condenser, inspecting the primary and secondary water temperature sensors. Both the primary and device, and replenishing the internal cleaning solution that suppresses secondary safety systems must respond to the fault and be verified by the microorganism growth in the water reservoir and hydraulic circuit. opposing safety system. If either safety systems do not respond appropri- ately either an alarm 80 or 81 will be issued. Contact Medivance Customer External Surfaces Support. • Clean the exterior body of the control module, fluid delivery lines, power cords and temperature cables using a soft cloth and mild deter- Non-Recoverable Alarms gent or disinfectant according to hospital protocol. If an Alarm condition occurs that prevents proper use of the device or proper patient treatment (such as the five main safety alarms discussed Condenser above), the system is placed into Stop mode and will not allow therapy to • A dirty chiller condenser will significantly reduce the cooling capacity continue. This type of Alarm is known as Non-Recoverable. If this situation of the control module. occurs, cycle the device power (turn device Off then On). If the alarm • To clean the condenser, wipe the dust from the exterior grill using a recurs contact Medivance Customer Support. soft cloth. Depending on the quality of your institution’s air, periodically 8