Artic Stat Operators Manual

Operator’s Manual

TABLE OF CONTENTS I. SYMBOLS... 3 II. WARNINGS AND CAUTIONS DEFINITION... 6 III. SAFETY PRECAUTIONS... 7 WARNINGS... 7 CAUTIONS... 7 COMPLICATIONS... 8 IV. INTRODUCTION... 9 TECHNICAL DESCRIPTION... 9 INDICATIONS FOR USE... 9 SPECIFICATIONS... 9 SYSTEM COMPONENTS...10 V. SETUP PROCEDURE...12 UNPACK...12 CONNECTIONS...12 POWER ON...12 FILL RESERVOIR...12 FUNCTIONAL VERIFICATION...12 VI. OPERATION GUIDE...13 THERAPY PREPARATION...13 Place ArcticGel™ Pads...13 Connect ArcticGel™ Pads...13 Patient Placement...13 Temperature Probe Placement...13 THERAPY SELECTION...13 New Patient–Normothermia...13 New Patient–Hypothermia...13 Confirm New Patient...13 Current Patient...13 PATIENT PAD SELECTION...13 THERAPY SCREENS...14 INITIATE THERAPY...20 INTERRUPT THERAPY FOR PATIENT TRANSPORT...21 END THERAPY...21 THERAPY SETTINGS...22 ADVANCED SETUP...26 VII. ALARMS...29 MEDIUM PRIORITY ALARMS...29. LOW PRIORITY ALARMS...29 VIII. TROUBLESHOOTING...30 WATER...30 Water Not Cooling...30 Water Not Warming...30 Extended Cold Water Exposure...30 Extended Warm Water Exposure...31 Low Water Flow...31 PATIENT TEMPERATURE...31 Patient Not Controlling...31 No Patient Temperature Display...32 SCREEN...32 Screen Locked...32 Wireless Connection Lost...32

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IX. CLEANING AND DISINFECTION... 33

SURFACE CLEANING...33 SURFACE DISINFECTION...33 VISUAL INSPECTION AND RETURN TO USE...33 X. MAINTENANCE AND SERVICE...34 INSPECT CONNECTORS AND CABLES ...34 CONDENSER...34 DEVICE INSPECTION...34 REPLENISH INTERNAL SOLUTION...34 INSPECT SCREEN PROTECTOR...34 INSPECT FLUID DELIVERY LINE...34 INSPECT MANIFOLD O-RING...35 SYSTEM DIAGNOSTICS...35 SERVICE...35 CALIBRATION...35 XI. PREVENTATIVE MAINTENANCE...35 XII. CUSTOMER SUPPORT...35 APPENDIX A: ELECTROMAGNETIC COMPATIBILITY...36 APPENDIX B: ALARMS...38 APPENDIX C: WARRANTY...52

English

I.

SYMBOLS

The Arctic Sun™ Temperature Management System and its packaging bear the following symbols: Symbol

Standard Reference

Standard Title

Symbol Title

Explanatory Text

ISO 15223-1 Reference no. 5.1.1

Medical DevicesSymbols to be used with medical device labels, labelling and information to be supplied

Manufacturer

Indicates the medical device manufacturer.

ISO 15223-1 Reference no. 5.1.3

Medical DevicesSymbols to be used with medical device labels, labelling and information to be supplied

Date of manufacture

Indicates the date when the medical device was manufactured.

ISO 15223-1 Reference no. 5.1.4

Medical DevicesSymbols to be used with medical device labels, labelling and information to be supplied

Use-by date

Indicates the date after which the medical device is not to be used.

ISO 15223-1 Reference no. 5.1.5

Medical DevicesSymbols to be used with medical device labels, labelling and information to be supplied

Batch code

Indicates the manufacturer’s batch code so that the batch or lot can be identified.

ISO 15223-1 Reference no. 5.1.6

Medical DevicesSymbols to be used with medical device labels, labelling and information to be supplied

Catalogue number

Indicates the manufacturer’s catalogue number so that the medical device can be identified.

ISO 15223-1 Reference no. 5.1.7

Medical DevicesSymbols to be used with medical device labels, labelling and information to be supplied

Serial number

Indicates the manufacturer’s serial number so that a specific medical device can be identified.

ISO 15223-1 Reference no. 5.3.7

Medical DevicesSymbols to be used with medical device labels, labelling and information to be supplied

Temperature limit

Indicates the temperature limits to which the medical device can be safely exposed.

ISO 15223-1 Reference no. 5.3.8

Medical DevicesSymbols to be used with medical device labels, labelling and information to be supplied

Humidity limitation

Indicates the range of humidity to which the medical device can be safely exposed.

ISO 15223-1 Reference no. 5.3.9

Medical DevicesSymbols to be used with medical device labels, labelling and information to be supplied

Atmospheric pressure limitation

Indicates the range of atmospheric pressure to which the medical device can be safely exposed.

ISO 15223-1 Reference no. 5.4.2

Medical DevicesSymbols to be used with medical device labels, labelling and information to be supplied

Do not re-use

Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure. 3

Operator’s Manual Symbol

Standard Reference

Standard Title

Symbol Title

Explanatory Text

IEC TR 60878 Reference ISO 7010-M002

Graphical Symbols for Electrical Equipment in Medical Practice

Refer to instruction manual/booklet

To signify that the instruction manual/booklet must be read.

IEC TR 60878 Reference no. 6050

Graphical Symbols for Electrical Equipment in Medical Practice

Model number

To identify the model number or type number of a product. In the application of this symbol, the model number or type number of the product should be accompanied with this symbol.

IEC TR 60878 Reference no.5334

Graphical Symbols for Electrical Equipment in Medical Practice

Defibrillation-proof type BF applied part

To identify a defibrillation-proof type BF applied part complying with IEC 60601-1.

IEC TR 60878 Reference no. 5041

Graphical Symbols for Electrical Equipment in Medical Practice

Caution, hot surface

To indicate that the marked item can be hot and should not be touched without taking care.

IEC TR 60878 Reference no. 0029

Graphical Symbols for Electrical Equipment in Medical Practice

Draining; emptying

To indicate the emptying of any vessel, or container of liquid or produce, for example draining of oil tanks, draining ink reservoirs, or emptying grain hoppers.

IEC TR 60878 Reference no. 0028

Graphical Symbols for Electrical Equipment in Medical Practice

Filling

To indicate the filling of a vessel or container by any type of liquid or produce, for example filling of oil tanks, filling ink reservoirs, filling grain hoppers.

IEC TR 60878 Reference ISO 7010-W012

Graphical Symbols for Electrical Equipment in Medical Practice

Warning; Electricity

To warn of electricity.

IEC TR 60878 Reference 7010P017

Graphical Symbols for Electrical Equipment in Medical Practice

No pushing

To prohibit pushing against an object.

IEC TR 60878 Reference 7010W001

Graphical Symbols for Electrical Equipment in Medical Practice

General Warning Sign

To signify a general warning.

IEC TR 60878 Reference no. 5007 & 5008

Graphical Symbols for Electrical Equipment in Medical Practice

Power On/Off

Indicates power on/off switch

#

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English Symbol

Standard Reference

Standard Title

Symbol Title

Explanatory Text

IEC TR 60878 Reference no. 5021

Graphical Symbols for Electrical Equipment in Medical Practice

Equipotentiality

To identify the terminals which, when connected together, bring the various parts of an equipment or of a system to the same potential, not necessarily being the earth (ground) potential, e.g. for local bonding.

IEC TR 60878 Reference no. 2794

Graphical Symbols for Electrical Equipment in Medical Practice

Packaging Unit

To indicate the number of pieces in the package.

IEC TR 60878 Reference no. 0623

Graphical Symbols for Electrical Equipment in Medical Practice

This way up

On transport packaging. To indicate the correct upright position.

IEC TR 60878 Reference no. 0621

Graphical Symbols for Electrical Equipment in Medical Practice

Fragile; handle with care

On transport packaging. To indicate the content of the package is fragile and that the package must be handled with care.

IEC TR 60878 Reference no. 0626

Graphical Symbols for Electrical Equipment in Medical Practice

Keep away from rain

Indicates a medical device that needs to be protected from moisture.

Directive 2002/96/EC (WEEE)

Marking of electrical and electronic equipment in accordance with Article 11(2) of Directive 2002/96/EC (WEEE)

Waste Stream Disposal Status

Do not dispose of electronic products in the general waste stream

21CFR801.15

Labeling; Prescription devices

Prescription Use Only

Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

AAMI ES 60601-1 IEC 60601-1-8 IEC 60601-10 IEC 806012-35 CSA C22.2 No. 6060101

Medical electrical equipment-Part 1: General requirements for basic safety and essential performance

ETL Monogram

Per ETL Intertek, models of the ARCTIC SUN™ Temperature Management System that bear the ETL Monogram confirm to AAMI ES60601-1, IEC 60601-1-8, IEC 6060110, IEC 80601-2-35 and are certified to CSA C22.2 No. 60601-1.

only

ETL CLASSIFIED

5

Operator’s Manual Symbol

STERILE WATER ONLY

Standard Reference

Standard Title

Symbol Title

Explanatory Text

ISO 7000 Reference no. 3650

Graphical symbols for use on equipment

Universal Serial Bus (USB), port/plug

To identify a port or plug as meeting the generic requirements of the Universal Serial Bus (USB). To indicate that the device is plugged into a USB port or is compatible with a USB port.

IEC 60417 Reference no. 5850

Graphical symbols for use on equipment

Serial interface

To identify a connector for a serial data connection

N/A

N/A

N/A

Indicates that only sterile water should be used when filling the ARCTIC SUN™ Temperature Management System Control Module.

N/A

N/A

N/A

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

N/A

N/A

N/A

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

N/A

N/A

N/A

Identifies Patient Temperature Out, the patient temperature output to an external hospital monitor.

N/A

N/A

N/A

Identifies mechanical hazard

N/A

N/A

N/A

Do Not Discard

N/A

N/A

N/A

To identify the number to call for urgent clinical support. The number shall be placed adjacent to the symbol.

N/A

N/A

N/A

Plug Type

DO NOT USE TAP WATER

TEMP IN

1 TEMP IN

2 TEMP OUT

MECHANICAL HAZARD

Do Not Discard

TYPE PLUG

II. WARNINGS AND CAUTIONS DEFINITION WARNINGS and CAUTIONS throughout the manual should be carefully reviewed before and during use of the device.

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WARNING

Informs the reader about a situation which, if not avoided, could result in death or serious injury. It may also describe potential serious adverse reactions and safety hazards.

CAUTION

Informs the reader about a situation which, if not avoided, could result in minor or moderate injury to the user or patient of damage the device or other property. This includes special care necessary for the safe and effective use of the device and the care necessary to avoid damage to a device that may occur as a result of use or misuse.

English

III. SAFETY PRECAUTIONS WARNINGS •

 o not use the Arctic Sun™ Temperature Management D System in the presence of flammable agents because an explosion and/or fire may result. • D  o 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, water gels, and patient coverings in use while warming, cooling, or not delivering therapy 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 temperature can impact drug delivery rate, resulting in possible harm to the patient. • The Arctic Sun™ Temperature Management System is not intended for use in the operating room environment. • Protection of mechanical equipment against the effects of the discharge of cardiac defibrillators is dependent upon the use of appropriate cables. Use of temperature cables listed in the System Components section of the Operator’s Manual is recommended. • Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Arctic Sun™ Temperature Management System, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. • BD 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 hyperthermia.

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 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’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 clinician and/or 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 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. It is recommended to use the Patient Temperature High and Patient Temperature Low alarm settings. • Manual Control is not recommended for patient temperature management. The operator is advised to use the automatic therapy modes (e.g. Control Patient, Cooling, Rewarming) 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. • It is recommended to measure patient temperature from a second site to verify patient temperature. BD recommends the use of a second patient temperature probe connected to Arctic Sun™ Temperature Management System Temp In 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 System. • 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. 7

Operator’s Manual CAUTIONS (Continued) • 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 a 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. Possible skin injuries include bruising, tearing, skin ulcerations, blistering, and necrosis. 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. • 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. • 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, 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 8

target temperature to an attainable setting or discontinuing treatment. • 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 thermal injury. • 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. • BD will not be responsible for patient safety or equipment performance if the procedures to operate, maintain, modify or service the Arctic Sun™ Temperature Management System are other than those specified by BD. Anyone performing the procedures must be appropriately trained and qualified. • The clinician and/or operator is responsible for clinical decisions based on Arctic Sun Work to Cool data provided by the system. The displayed graphics are for general information purposes only and are not intended to replace standard medical record documentation for use in therapy decisions. Anyone interpreting the Arctic Sun Work to Cool data to make clinical decisions must be appropriately trained and qualified.

COMPLICATIONS • Targeted Temperature Management can trigger pathophysiological side-effects on the body such as but not limited to: cardiac dysrhythmia, electrolyte and pH balance, metabolic changes, hemodynamic changes, blood-glucose balance, infection, shivering, and can affect the coagulation, respiratory, renal and neurological systems. The controlling of patient temperature should only be performed under the supervision of a qualified healthcare professional.

English

IV. INTRODUCTION

Parameter

Specification

TECHNICAL DESCRIPTION

Therapy Modes

Normothermia: Control Patient, Rewarming Hypothermia: Cooling, Rewarming

Heater Maximum Power

814 Watts

Circulating Fluid

Sterile Water with Cleaning Solution

Average Reservoir Capacity

3.5 liters

Patient Probe Type

YSI 400 Series compatible

Patient Temperature Inputs

Temp In 1: control, monitor, alarm Temp In 2: monitor, alarm

Patient Temperature Display Range

10°C to 44°C/50°F to 111.2°F 0.1°C/°F increments

Patient Temperature Measurement Accuracy

±0.4°C (10°C to 32°C/50°F to 89.6°F) ±0.2°C (32°C to 38°C/89.6°F to 100.4°F) ±0.4°C (38°C to 44°C/100.4°F to 111.2°F) Excludes external probe

Responses of the PCLCS (Physiologic Closed-Loop Control System)

Settling Time: ~4.5 hours Relative Overshoot: <0.5°C Command Overshoot: <0.5°C Warming (max) Response Time: 32°C to 37°C/89.6°F to 98.6°F: ~8.5 hours Cooling Response Time: 37°C to 33°C/98.6°F to 91.4°F: ~2 hours Steady State Deviation: 0 Tracking Error: 0 Note: All values derived from testing in simulated use

Patient Temperature Control Range

32°C to 38.5°C/89.6°F to 101.3°F 0.1°C/°F increments

Water Temperature Display Range

3°C to 45°C/37.4°F to 113.0°F 0.1°C /°F increments

Water Temperature Control Range (Manual)

4°C to 40°C 1°C increments

High Water Temperature Limit

36°C to 40°C 1°C increments

Low Water Temperature Limit

4°C to 25°C 1°C increments

Time to heat water from 25°C to 40°C

<15 minutes

Time to lower water temperature from 25°C to 7°C

<15 minutes

Sound Pressure

Low Priority Alarm: 64-71dB at 1 meter Medium Priority Alarm: 64-71dB at 1 meter Reminder Tone: 65dB at 3 meters

Mains Input

120VAC 60Hz 11Amp

Total Patient Leakage Current (Normal Condition)

<300 μA

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). A patient temperature probe connected to the Control Module provides patient temperature feedback to an internal control algorithm which automatically increases or decreases the circulating water temperature to achieve a pre-set patient target temperature determined by the clinician. The Arctic Sun™ Temperature Management System pulls temperature-controlled water ranging between 4°C and 40°C (39.2°F and 104°F) through the ArcticGel™ pads. This results in heat exchange between the water and the patient. The Arctic Sun™ Temperature Management System Control Module is a Class I mobile device (Type BF, IPX0 and Mode of Operation – Continuous) per classification scheme of IEC 60601-1. The Arctic Sun™ Temperature Management System Control Module meets both the electromagnetic interference and susceptibility requirements of IEC 60601-1, and is compatible with other equipment that also conforms to that standard. There is no known failure mode in the Arctic Sun™ Temperature Management System Control Module associated with electromagnetic interference from other devices. See Appendix A for the full declaration regarding electromagnetic compatibility.

INDICATIONS FOR USE The Arctic Sun™ Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature in adult and pediatric patients of all ages.

SPECIFICATIONS Environmental Conditions At operating temperatures higher than 27°C (80.6°F), 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, perform the Total Drain process. See section VI. Operation Guide–Advanced Setup–Total Drain for further instructions. Disposal Upon end of life, dispose of in accordance with local WEEE regulations or contact your local BD Supplier or Distributor to arrange for disposal.

Operating Relative Humidity Range 5% to 70% non-condensing Storage and Transport Relative Humidity Range

5% to 95% non-condensing

Operating Temperature Range

15.5°C to 32.2°C/59.9°F to 90.0°F

Storage and Transport Temperature Range

-30°C to 50°C/-22°F to 122°F

Atmospheric Pressure Range

60 kPa to 101 kPa

Dimensions

Height: 41 inches (104 cm) Width: 16 inches (41 cm) Depth: 20 inches (51 cm)

Weight

Filled: 55.3 kg/122 lbs

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Operator’s Manual SYSTEM COMPONENTS

Serial Number Patient Temp 1 Patient Temp 2 Patient Temp Out

Power Cord

Fill Tube A Fill Tube is used to fill the Control Module water reservoir.

RS232 Port Ethernet Port Power Switch

USB Port Fluid Delivery Line Port Fill Tube Parking

Air Filter

Arctic Sun Cleaning Solution Arctic Sun Cleaning Solution is added when filling the Control Module with Sterile Water. This is done to suppress microorganism growth in the water reservoir and hydraulic circuit. For information regarding safe handling, please refer to http://www.medivance.com/manuals for the Cleaning Solution SDS. Patient Temperature Input Cables and Probes Patient temperature control with the Arctic Sun™ Temperature Management System requires patient temperature feedback provided by an indwelling patient temperature probe connected to the Control Module via the Temp In 1 and Temp In 2 inputs. Any commerciallyavailable Yellow Springs Instrument 400 Series (YSI 400) compatible patient temperature probe can be connected to the Arctic Sun™ Temperature Management System. The Arctic Sun™ Temperature Management System temperature cables are available with several connector styles (e.g. Phillips, GE, Rusch, Bard, Nellcor) for compatibility with various manufacturers’ temperature probes. Select the patient temperature cable with the correct connector style for your chosen temperature probe.

Figure IV-1. Product illustration Control Module The Arctic Sun™ Temperature Management System Control Module is the main component of the Arctic Sun™ Temperature Management System. It incorporates the system electronics, hydraulics, software, and the touchscreen Control Panel. The power cord, fluid delivery line, patient temperature in cables, patient temperature out cable and fill tube connect to the rear of the Control Module. The figure above identifies the main features and component connection sites. Use only BD supplied cables and accessories with Arctic Sun™ Temperature Management System Control Module. The use of accessories, transducers or cables other than those specified may result in increased electromagnetic compatibility (EMC) emissions or decreased immunity of the Arctic Sun™ Temperature Management System Control Module. Power Cord Hospital-grade power cords are available with several inlet connector styles to meet national/regional power requirements and wall outlet specifications. Fluid Delivery Line Water flows between the ArcticGel™ pads and Control Module through the Fluid Delivery Line.

10

735-06 Philips 4' - 1.2m

735-05 GE 10' - 3m

735-04 Rusch 10' - 3m

735-03 Bard 10' - 3m

735-02 Nellcor 10' - 3m

Figure IV-2. Temperature input cables A temperature cable and probe connected to the Temp In 1 connector provides the patient temperature feedback required for automatic patient temperature control. A second patient temperature probe and cable are recommended to be connected into the Temp In 2 Connector. Temp In 2 is used to provide monitoring from a second patient site for increased patient safety when patient temperature is not continuously monitored by a second device. NOTE: Patient temperature is not controlled from the Temp In 2 connector. It is for patient temperature monitoring only.

English SYSTEM COMPONENTS (Continued) Patient Temperature Output Cables The Arctic Sun™ Temperature Management System Control Module has the capability to output the current Temp In 1 reading to a YSI 400 compatible hospital monitor. The Arctic Sun™ Temperature Management System temperature output cables are available with several connector styles (e.g. Phillips, GE, Rusch, Bard, Nellcor) for compatibility with the various hospital monitor input cables. Select the patient temperature cable with the correct connector style for your hospital monitor. NOTE: The temperatures displayed on the Arctic Sun™ Temperature Management System Control Panel and the hospital monitor represents the same probe reading but may not be identical due to calibration differences between the Control Module and the monitor.

735-56 Philips 10' - 3m

735-55 GE 10' - 3m

735-54 Rusch 19" - 50cm

735-53 Bard 19" - 50cm

735-52 Nellcor 19" - 50cm

Figure IV-3. Temperature output cables

11

Operator’s Manual

V.

SETUP PROCEDURE

UNPACK 1) Unpack the Arctic Sun™ Temperature Management System Control Module and accessories. 2) Allow the Control Module to remain upright for at least two 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 approved cables and accessories with the Arctic Sun™ Temperature Management System Control Module (Appendix B). 2) Inspect the accessories for wear, breakage, or fraying before use. Replace if necessary. 3) Connect the Fluid Delivery Line, Temp In 1 cable, Temp In 2 cable (optional), Temp Out cable and Fill Tube to the back of the Control Module. 4) Plug the Power Cord into the wall outlet. Position the Arctic Sun™ Temperature Management System so that access to the power cord is not restricted.

POWER ON 1) Power On by activating the power switch on the back of the device. 2) The patient Therapy Selection screen will appear on the control panel.

FILL RESERVOIR Approximately four liters of sterile water will be required to fill the reservoir at initial installation. Fill the reservoir with sterile water only. When filling the Control Module during initial installation or when completely empty, add one vial of Arctic Sun™ Temperature Management System Arctic Sun Cleaning Solution to the sterile water. It is recommended to add the vial when filling with the second liter of sterile water. 1) From the patient Therapy Selection screen, select the button next to either Normothermia or Hypothermia under the New Patient heading. Select any pad type to continue. 2) From the Hypothermia or Normothermia therapy screen, press the Fill Reservoir button. 3) The Fill Reservoir screen will appear. Follow the directions on the screen. 4) The filling process will automatically stop when the reservoir is full. Continue to replace the bottles of sterile water until the filling process stops. 5) When the Fill Reservoir process is complete, the screen will close. 6) To stop the process early, press the Stop button. NOTE: If the filling cycle is stopped prior to completion, the reservoir will not be full and may requiring filling after fewer patient therapies have been performed. 7) Press the Cancel button to close the screen. 12

FUNCTIONAL VERIFICATION Certificates of Conformance for calibration, performance, and electrical safety tests are included with the shipment of each Arctic Sun™ Temperature Management System. To verify the system will heat and cool properly, perform the following functional verification procedure after initial setup and installation of the Control Module. 1) Power On the Control Module. 2) From the patient Therapy Selection screen, press the button next to Hypothermia to display the Hypothermia therapy screen. Select the adult pad type to continue. 3) From the Hypothermia therapy screen, press the Manual Control button to open the Manual Control window. If the Manual Control button is not visible, select the Adjust button at the bottom of the screen and select the More button to access the therapy settings screen. Enable Manual Control and save your settings to close the window. 4) Use the Up and Down arrows to set the Manual Control water target temperature to 40°C and the duration to 30 minutes. 5) Press the Start button to initiate Manual Control. Allow at least 3 minutes for the system to stabilize. 6) Monitor the flow rate and water temperature in the System status area on the Hypothermia therapy screen. 7) Verify that the flow rate reaches at least 1.5 liters/minute. 8) Verify that the water temperature increases to at least 30°C. 9) Press the Stop button. 10) Set the Manual Control water target temperature to 4°C and the duration to 30 minutes. 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 drops to 6°C or colder. 13) Press the Stop button to stop Manual Control 14) Press the Cancel button to close the Manual Control window. 15) Before placing the device into clinical use, it is recommended to disable Manual Control unless requested by clinical users. Select the Adjust button at the bottom of the therapy screen and select the More button to access the therapy settings screen. Disable Manual Control and save your settings to close the window. 16) Power Off the Control Module.

English

VI. OPERATION GUIDE THERAPY PREPARATION Place ArcticGel™ Pads Read the Instructions for Use that accompanies the ArcticGel™ pads. Examine each pad for damage prior to placement. Connect ArcticGel™ Pads Water flows between the ArcticGel™ pads and Control Module via a Fluid Delivery Line. Each side of the Fluid Delivery Line can be placed by the feet or along the lower legs. There are three connectors on each side of the line for a total of six connectors. These will accommodate a full kit of four pads plus a maximum of two optional Universal pads for use in larger patients. To connect the ArcticGel™ Pads: 1) While holding the pad line tubing, insert the clear pad line connector into the Fluid Delivery Line manifold. Do not press or squeeze the wings when connecting. The connector will click into place. 2) If the connectors are not aligned properly, the connectors will not fit or click into place. Patient Placement The Arctic Sun™ Temperature Management System operates under negative pressure, which helps the pads to conform to the patient’s body and minimizes the risk of leaks in the event of accidental puncture of a pad or accidental disconnection of the Fluid Delivery Line. In order to ensure negative pressure on the pads at all times, the patient’s bed surface should be placed 30 inches to 60 inches (75 cm to 150 cm) above the floor. Device Placement It is recommended to position the device near the foot of the bed during use. Use the wheel locks on the Control Module to prevent the wheels from rotating during use. Press down on the wheel locks to lock the wheels, and lift up the wheel locks to release the wheels. Temperature Probe Placement Refer to the manufacturer’s Instructions for Use for the specific indications and temperature probe placement. Select the patient temperature cable with the correct connector style for your chosen temperature probe to measure core temperature. Insert the cable into the Temp In 1 connector port on the back of the device for monitoring patient temperature on the Arctic Sun™ Temperature Management System.

Pressing the Normothermia button will initiate a New Patient therapy and will reset the Normothermia therapy screen to the saved system default settings. Any active, current patient therapy settings and patient data will no longer be available. New Patient–Hypothermia If the therapy goal is to reduce and maintain a patient temperature at a set target temperature for a defined period of time then slowly rewarm the patient at a controlled rewarming rate, press the button next to Hypothermia to display the Hypothermia therapy screen. Pressing the Hypothermia button will initiate a new patient therapy and will reset the Hypothermia therapy screen to the saved system default settings. Any active, current patient therapy settings and data will no longer be available. Additional Protocol Option Two additional protocols (Hypothermia or Normothermia) may be visible on the Therapy Selection screen. See VI. Operation Guide–Advanced Setup–Save Settings as Default for instructions on how to add custom protocols on the Therapy Selection screen. Confirm New Patient The therapy selected will override the active, current patient therapy. To continue a current case, press Continue. To begin a new therapy, press New. Current Patient The Continue Current Patient button and the date and time that the current therapy was paused will display on the Therapy Selection screen if a patient therapy was paused within the past 6 hours. Press the Continue button to resume a paused patient therapy. Selecting the Continue button will display the appropriate therapy screen. The therapy screen will retain and display the previously set therapy settings and patient data. NOTE: Continuation of a current patient therapy will be available whether the Control Module was Powered On or Off in the preceding 6 hours.

PATIENT PAD SELECTION

Once the therapy has been selected, the user will be prompted with the Pad Selection screen. Select the appropriate pad type based on the pads placed on the patient.

THERAPY SELECTION Use the Therapy Selection screen to initiate a New Patient, Continue a Current Patient, or access the Advanced Setup screen. New Patient–Normothermia If the therapy goal is to maintain a patient temperature at a pre-defined target temperature for an indefinite period of time, press the button next to Normothermia to display the Normothermia therapy screen.

Figure VI-1. Pad selection screen

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Operator’s Manual THERAPY SCREENS The following information is displayed and functions are available from the Normothermia and Hypothermia therapy screen. 1. 2. 3. 4. 5.

Therapy Selection (or Screen Lock) System Access Notification Temperature Units (if enabled) Patient Status A. Patient Temperature B. Patient Temperature 2 (if enabled) 6. System Status C. Water Temperature D. Flow Rate 7. Therapy Graph E. Patient Temperature F. Water Temperature G. Date and Time H. Progress Bar 8. Empty Pads 9. Fill Reservoir 10. Monitor Mode 11. Arctic Sun Work to Cool Trend 12. Control (Normothermia Screen) Cooling (Hypothermia Screen) 13. Start/Stop 14. Adjust 15. WiFi Connected (if enabled) 16. Rewarming (Hypothermia Screen)

The following information is displayed and functions are available from the Normothermia and Hypothermia therapy screen. 1. 2. 3. 4. 5.

Therapy Selection (or Screen Lock) System Access Notification Temperature Units (if enabled) Patient Status A. Patient Temperature B. Patient Temperature 2 (if enabled) 6. System Status C. Water Temperature D. Flow Rate 7. Therapy Graph E. Patient Temperature F. Water Temperature G. Date and Time H. Progress Bar 8. Empty Pads 9. Fill Reservoir 10. Monitor Mode 11. Arctic Sun Work to Cool Trend 12. Control (Normothermia Screen) Cooling (Hypothermia Screen) 13. Start/Stop 14. Adjust 15. WiFi Disconnected (if enabled)

Figure VI-3. Normothermia therapy screen when using adult ArcticGel™ pads Figure VI-2. Hypothermia therapy screen when using adult ArcticGel™ pads

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English THERAPY SCREENS (Continued) 1. Therapy Selection If the therapy has not started or is not currently running, pressing the therapy selection button ( ) will return the user to the Therapy Selection screen. Screen Lock When an active therapy is running, the therapy selection button will change to the screen lock button ( ). Press the screen lock button to manually display the therapy status screen. By default, after approximately 2 minutes of inactivity, the screen will lock to prevent inadvertently changing parameters during patient therapy. The therapy status screen will appear over the therapy screen when the screen is locked. The status screen displays the Patient Temperature, Water Temperature, Arctic Sun Work to Cool, and the current therapy phase target temperature. Press the button on the top right of the status screen to return to the therapy screen. See section VIII. Troubleshooting–Screen–Screen Locked if there is a problem with screen lock.

3. Notification Notifications are active when attention to the system is required (e.g. preventative maintenance). When a notification is active, a small icon ( ) will appear next to the System Access button. Press the System Access button to read the notification. 4. Temperature Units (if enabled) From the Normothermia therapy screen or the Hypothermia therapy screen, press the °C/°F button to toggle the displayed patient and water temperatures between °C and °F. NOTES: The °C/°F button is not visible when the Temperature Units Adjust parameter in Normothermia Settings or Hypothermia Settings is disabled. Set the Temperature Units Adjust parameter to enabled in order for the °C/°F button to display. See section VI. Operation Guide–Therapy Settings– Temperature Units Adjust for further instructions on enabling/disabling this feature. 5. Patient Status The following Patient status information is displayed in the upper left side of the therapy screen. A. Patient Temperature • Displays the temperature input from the Temp In 1 connector. • Temp In 1 is the patient temperature input utilized by the device for automatic patient temperature control. Range: 10°C to 44°C 50°F to 111.2°F Increments: 0.1°C/°F

Figure VI-4. Status Screen 2. System Access The System Access screen allows the user to view diagnostic information and a log of events during the last 10 cases. Diagnostics Selecting the Diagnostics button on the System Access screen allows the user to view the flow, pressure, patient temperature and individual water temperature sensor readings. This information is valuable during the troubleshooting process. Event Log Selecting the Event Log button on the System Access Screen will display a record of non-recoverable system alarms and recoverable alarms from the last 10 cases. After 10 cases, the event log will overwrite the data in a first in, first out format when new cases are initiated. The Event Log is still maintained when the system is powered down or if the system experiences a complete loss of power. Time of power down is not captured in the Event Log.

• If a patient temperature probe is not connected into the Temp In 1 connector, or the temperature is out of the display range, then the patient temperature will display dashes (--.-). • If a patient temperature probe is not connected into the Temp In 1 connector when you attempt to Start therapy, an alarm will occur. B. Patient Temperature 2 (if enabled) • Displays the temperature input to the Temp In 2 connector. • Temp In 2 is for additional patient temperature monitoring only. It is not utilized by the device for automatic patient temperature control. Range: 10°C to 44°C 50°F to 111.2°F Increments: 0.1°C/°F • If a patient temperature probe is not connected into the Temp In connector, or the temperature is out of the display range, then the patient temperature will display dashes (--.-). 15

Operator’s Manual THERAPY SCREENS (Continued) •  Patient Temperature 2 must be enabled in the Normothermia Settings or Hypothermia Settings for Patient Temperature 2 to display. NOTE: See section VI. Operation Guide–Therapy Settings–Patient Temperature 2 for instructions on enabling/disabling Patient Temperature 2. 6. System Status The following System status information is displayed in the upper right side of the therapy screen. C. Water Temperature • Displays the temperature of the circulating water. • If the current water temperature is at the pre-set “high water temperature” or “low water temperature” limit, then the word “Limit” will appear on the screen, next to the displayed water temperature. D. Flow Rate Displays the water flow rate in liters per minute. 7. Therapy Graph The temperature graph displays the patient temperature history, patient target temperature, water temperature history, and Monitor Mode thresholds (if enabled) over time on the therapy screen. E. Patient Temperature • The patient temperature scale displays in yellow on the left side of the graph. • The patient temperature is represented on the graph by a solid thick yellow line. (If Patient Temperature 2 is enabled it is represented by a thin yellow line.) • The patient target temperature is represented on the graph by a dotted yellow line. F. Water Temperature • The water temperature scale displays in blue on the right side of the graph. • The water temperature is represented on the graph by a solid blue line. G. Date and Time • The temperature graph is divided into 5 segments denoted by time markers 00:00, 04:00, 08:00, 12:00, 16:00, and 20:00. • During Hypothermia therapy, the graph background is color coded to represent the current time remaining in both the Cool and Rewarm therapies. • A vertical time line displays to signify the current system time. • Use the arrows on either side of the graph to scroll the graph backward or forward in time. Each press of the scroll arrow will advance the screen 15 minutes. 16

H. Progress Bar • A progress bar displays on the bottom of the temperature graph to signify the operating modes active throughout the therapy. • A green line denotes Control Patient, Cooling or Rewarming. • A blue line denotes Manual Control. • A red line denotes Stop mode. • No line represents time when system was Powered Off or when the current case was not active. 8. Empty Pads The Empty Pads feature empties water from the ArcticGel™ pads and fluid delivery lines into the Control Module reservoir. To Empty Pads: 1) From the Normothermia therapy screen or the Hypothermia therapy screen, press the Empty Pads button. 2) The Empty Pads window will appear. Follow the directions on the screen. 3) Press the Empty button to begin to automatically empty the pads. 4) The Emptying Pads screen will appear and animate during the emptying process. 5) The emptying process will automatically stop when the pads are empty. 6) To stop the process early, press the Stop button. 7) Press the Cancel button to close the screen. NOTE: The Empty Pads button is not visible and the feature disabled when the Control, Cooling, Rewarming or Manual Control functions are active. The system must be in Stop mode for the Empty Pads button to be visible and functional. 9. Fill Reservoir See section V. Setup Procedure–Fill Reservoir.

English THERAPY SCREENS (Continued) 10. Monitor Mode The Monitor Mode feature delivers active therapy when user-defined thresholds are crossed. This feature is useful for temperature surveillance of the patient. The Monitor Mode button appears on the therapy screen when Monitor Mode is enabled as Automatic or Manual in the therapy settings. Press the Monitor Mode button to display the Monitor Mode–Adjust window. Use the Up and Down arrows to adjust the Upper limit, Lower limit, and Duration limits.

Upper limit Control Strategy Range: Increments: Lower limit Control Strategy Range: Increments: Duration Limit Range: Increments:

1,2 33.5°C to 38.5°C 92.3°F to 101.3°F 0.1°C/°F

3 32.5°C to 38.5°C 90.5°F to 101.3°F 0.1°C/°F

1,2 33.0°C to 38.0°C 91.4°F to 100.4°F 0.1°C/°F

3 32.0°C to 38.0°C 89.6°F to 100.4°F 0.1°C/°F

0 to 1 hr. 0, 5, 10, 15, 30, 45, 60 min

NOTE: Monitor Mode is inaccessible during active cooling. When Monitor Mode is active, Arctic Sun Work to Cool will not be displayed, water temperature will be dashed, and flow rate will be zero in the therapy graph and status screen. NOTE: Monitor Mode only applies to the normothermia phase or the rewarming phase when the rate is set to Maximum. To start Monitor Mode, the difference between the patient temperature and target temperature must be within 0.5°C (0.9°F) and the patient temperature must be within the selected upper/lower limits. Figure VI-5. Monitor Mode Adjust Screen When activated, the Monitor Mode temperature limits will be displayed as dotted lines above and below the target temperature on the therapy screen. When active, the flow rate status will indicate “Monitoring” and the “Monitoring” message will be animated on the status screen. To stop Monitor Mode, press Stop on the main therapy screen. See VI. Operation Guide–Therapy Settings–Monitor Mode to activate Monitor Mode and change the Monitor Mode setting to Automatic, Disabled, or Manual. In Monitor Mode set to Automatic, the system will resume control of patient temperature to the configured target temperature when the patient temperature has been outside of the user-defined limits for greater than the user-defined duration limit. Return to patient temperature will occur as quickly as possible without ramp. In Monitor Mode set to Manual, an alert will appear on the screen after the patient temperature has been outside of the user-defined limits for greater than the user-defined duration limit. The alert will recur every 15 minutes if the temperature remains outside the limit bands. The user must then manually start therapy if desired from the Normothermia or Hypothermia therapy screen.

11. Arctic Sun Work to Cool The Arctic Sun Work to Cool feature will monitor the heat removed by the Arctic Sun Temperature Management System during active Normothermia or Hypothermia therapy when using Adult ArcticGel™ Pads. This feature measures changes in water temperature between the pads and the system in order to calculate average heat transfer to the Arctic Sun temperature management system. Arctic Sun Work to Cool levels are displayed on the Arctic Sun Work to Cool graph under the therapy graph and on an Arctic Sun Work to Cool gauge displayed on the status screen. The Arctic Sun Work to Cool graph will begin to display once patient therapy has been started. Each bar represents the average heat removed during Hypothermia or Normothermia over the last 15 minutes. Arctic Sun Work to Cool is displayed in either blue or orange corresponding to changes in heat transfer to the Arctic Sun Temperature Management System during therapy. The threshold for the change in color from blue to orange can be adjusted in Therapy Settings, but will be set at a default of 250 W.

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Operator’s Manual THERAPY SCREENS (Continued) Color

Level (W)

Display

Blue

<250

Baseline

Orange

>250

High

When the heat transfer continues to increase above the established threshold, orange bars will appear on the Arctic Sun Work to Cool graph. Likewise, the Arctic Sun Work to Cool gauge on the status screen will appear orange.

NOTE: If the Arctic Sun™ Temperature Management System was previously in stop mode, or if the target temperature has been changed, the Arctic Sun Work to Cool Trend graph will be greyed, and the icon will display a grey hour glass for a period of 15 minutes. 12. Control Settings (Normothermia Screen) • The default patient target temperature will display in the Control window. • To modify the patient target temperature, press the Adjust button to display the Control–Adjust window. •  Control to: Use the Up and Down arrows to set the desired patient target temperature to control the patient. Range: Increments:

32.0°C to 38.5°C 89.6°F to 101.3°F 0.1°C/°F

•  Rewarm at a Rate of: Use the Up and Down arrows on the right of the screen to set the rewarming rate. Range: Increments: Figure VI-6. Arctic Sun Work to Cool gauge displaying as blue

0.01 to 0.50°C/hour 0.02 to 0.90°F/hour 0.01 and 0.05°C/hour

Cooling Settings (Hypothermia Screen) The Cooling window displays the cooling phase patient target temperature and the length of time remaining in the cooling phase of the Hypothermia Therapy. • The default patient target temperature and duration will display in the Cooling window. • To modify the patient target temperature and duration, press the Adjust button to display the Cooling–Adjust window. •  Cool To: Use the Up and Down arrows on the left side to set the desired patient target temperature to cool the patient.

Figure VI-7. Arctic Sun Work to Cool gauge displaying as orange When the Arctic Sun Work to Cool is displaying as blue, it is an indication that the Arctic Sun is not working hard to cool and the patient should be monitored as normal. When the Arctic Sun Work to Cool is displaying as orange, it is an indication that the Arctic Sun is working hard to cool and that the patient should be assessed for: shivering, seizure, fever, internal bleeding, or other causes of heat generation. See VI. Operation Guide–Therapy Settings–Work to Cool Threshold to change the temperature thresholds for Arctic Sun Work to Cool. NOTE: Bars will not be graphed when therapy is stopped by the user or when therapy is stopped due to a medium priority alarm. 18

Range: Increments:

32.0°C to 38.5°C 89.6°F to 101.3°F 0.1°C/°F

•  Cool For: Use the Up and Down arrows on the right side to set the duration (hours and minutes) to cool the patient before rewarming begins. Range: Increments:

15 minutes to 99 hours 15 minutes (0-8 hours) 1 hour (8-99 hours)

English THERAPY SCREENS (Continued) 13. Start or Stop Start Therapy From the Normothermia therapy screen or the Hypothermia therapy screen, press the Start button to start therapy and begin the flow of water to the ArcticGel™ pads. You will hear a tone and then a voice stating “Therapy Started.” Stop Therapy From the Normothermia therapy screen or the Hypothermia therapy screen, press the Stop button to stop therapy and halt the flow of water to the ArcticGel™ pads. You will hear a tone and then a voice stating “Therapy Stopped.” 14. Adjust Select the Adjust button on the therapy screen to change Control, Cooling, or Rewarming settings. Select More on the Adjust screen in order to display the therapy settings screen. Use the Hypothermia Settings or Normothermia Settings screen to view the current settings and modify the settings. See VI. Operation Guide–Therapy Settings for details on each setting parameter. 15. WiFi Connection Once the Arctic Sun™ Temperature Management System is initially connected to WiFi, there will be an indicator in the upper right corner of the therapy screen that displays the connection status. If the WiFi icon is white, the device is connected. If the WiFi icon is blue with a slash through it, the device is disconnected. 16. Rewarming (Hypothermia Therapy Screen) The Rewarming window displays the rewarming phase patient target temperature and the length of time remaining in the rewarming phase of the Hypothermia therapy. • The default patient target temperature and duration will display in the Rewarming window. • To change the rewarming phase patient target temperature and rewarming rate, press the Adjust button in the Rewarming window to display the Rewarming– Adjust screen. Use the Up and Down arrows on the left side to set the desired final patient target temperature. •  Rewarm To: Use the Up and Down arrows on the right side to set the desired final patient target temperature. Range: Increments:

32.0°C to 38.5°C 89.6°F to 101.3°F 0.1°C/°F

NOTE: The low end of the range is limited by the current target temperature. •  Rewarm at a Rate of: Use the Up and Down arrows in the center of the screen to set the rewarming rate. Range:

0.01°C/hour to 0.50°C/hour 0.02°F/hour to 0.90°F/hour

Increments:

0.01°C/hour (0.01-0.35°C/hour) 0.05°C/hour (0.35-0.50°C/hour) 0.02°F/hour (0.02-0.58°F/hour) 0.09°F/hour (0.59-0.90°F/hour)

•  Rewarm From: When cooling a patient, adjustment of the Rewarm From setting on the left side of the screen is disabled and defaults to the Cooling target temperature. • When rewarming a patient, the Rewarm From adjustment is enabled and the value can be modified. The Rewarm From setting is the temperature to which the system is currently controlling the patient. The Rewarm 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. • Using the Rewarm From temperature, the Rewarm To temperature and the rewarming rate settings, the system will calculate and display the rewarming duration and the date/time at which the patient will reach the final rewarming target temperature. NOTE: If the rewarming rate is set to Maximum, then the Rewarm From temperature will automatically set to the Rewarm To final target temperature and the rewarming duration will display as 0. 17. Patient Temperature Trend Indicator The Patient Temperature Trend Indicator reflects the rate of change in the patient’s temperature over the previous 5 minutes. The number of yellow arrows represents different rates of temperature change. Up arrows indicate the patient temperature is increasing; down arrows indicate that the patient temperature is decreasing. When assessing a patient, the practitioner may refer to the Patient Trend Indicator for insight into patient heat generation which may be indicative of shivering or fever generation. Trend Indicator

Patient Temperature Trend No trend established or no patient temperature input No change or less than 0.25°C (0.45°F) change per hour 0.25°C to 0.50°C (0.45°F to 0.90°F) change per hour 0.50°C to 0.75°C (0.90°F to 1.35°F) change per hour 0.75°C to 2.0°C (1.35°F to 3.6°F) change per hour Greater than 2.0°C (3.6°F) change per hour 19

Operator’s Manual THERAPY SCREENS (Continued) 18. Manual Control Use the Manual Control feature to circulate water at a set temperature through the ArcticGel™ pads for a set duration of time. Manual Control is not recommended for patient temperature management. The operator is advised to use the automatic therapy modes (e.g. Control Patient, Cooling, Rewarming) for automatic patient temperature monitoring and control. NOTE: The system patient temperature limit alarms will not automatically stop Manual Control but will only alarm the user to an over limit condition. Manual Control can be disabled or set to the default Manual Control water temperature and maximum time duration in the Normothermia Settings or Hypothermia Settings screen. If the Manual Control feature is disabled, the Manual Control button is not visible on the therapy screen. When activating Manual Control from the therapy screen, the user will have the option to select the Manual Control time duration. The Manual Control time duration range that is selectable will be limited by the maximum time duration set in Manual Control settings. See VI. Operation Guide–Therapy Settings–Manual Control.

INITIATE THERAPY Initiate Normothermia (Control Patient) Normothermia therapy is initiated and managed, and patient temperature is automatically controlled to a set target temperature from the Control Patient window in the Normothermia therapy screen. The Control Patient window displays the patient target temperature and the duration since the initiation of normothermia therapy. To initiate Normothermia therapy: 1) From the patient Therapy Selection screen, press the button next to Normothermia to display the Normothermia therapy screen. 2) The default patient target temperature will display in the Control window towards the bottom of the screen. 3) To modify the patient target temperature, press the Adjust button to display the Control Patient–Adjust window. 4)  Control Patient to: Use the Up and Down arrows to set the desired target temperature to control the patient. 5)  Rewarm at a Rate of: Use the Up and Down arrows on the right of the screen to set the rewarming rate. 6) Press the Save button to save the new settings and close the Control Patient–Adjust window. 7) Press Start, in the Control window to initiate therapy. You will hear a tone and then a voice stating “Therapy Started”. NOTE: For patient target temperature between 32°C and 32.9°C (89.6°F to 91.2°F) to be available for selection, Control Strategy 3 must be chosen in 20

Normothermia Settings. See VI. Operation Guide– Therapy Settings– Control Strategy for further instructions on setting the control strategy. Initiate Hypothermia (Cooling and Rewarming) Hypothermia therapy is initiated and managed, and patient temperature is automatically controlled to a set target temperature from the Cooling and Rewarming windows in the Hypothermia therapy screen. The Cooling window displays the cooling phase patient target temperature and the length of time remaining in the cooling phase of the Hypothermia therapy. The Rewarming window displays the rewarming phase patient target temperature and the length of time remaining in the rewarming phase of the Hypothermia therapy. To initiate Hypothermia therapy: From the patient Therapy Selection screen, press the button next to Hypothermia to display the Hypothermia therapy screen.

1)

Cooling Settings

• Press the Adjust button on the Cooling window to display the Cooling–Adjust window. Use the Up and Down arrows to set the desired patient target temperature and the desired cooling duration to cool the patient before rewarming begins. • Press the Save button to save the new settings and close the Cooling–Adjust window. • Press the Cancel button to close the Cooling–Adjust window without saving the new settings. NOTE: For patient target temperature between 32.0°C and 32.9°C (89.6°F to 91.2°F) to be available for selection, control strategy 3 must be chosen in Hypothermia Settings. See VI. Operation Guide– Therapy Settings–Control Strategy for further instructions on setting the control strategy. 2) Rewarming Settings • Press the Adjust button on the Rewarming window to display the Rewarming–Adjust screen. Use the Up and Down arrows to set the desired final patient target temperature and the desired rewarming rate. • Press the Save button to save the new settings and close the Rewarming–Adjust window. • Press the Cancel button to close the Rewarming– Adjust window without saving the new settings. 3) Initiate Patient Cooling  Press Start, in the Cooling window to initiate therapy. You will hear a tone and then a voice stating “Therapy Started.”