It s time for a new standard.

Transcription

1 It s time for a new standard.

2 Initiate in Minutes Intuitive Touchscreen Precision Targeting Advanced Thermal Transfer Clinician Support

3 With the Arctic Sun 5000 Temperature Management System, initiation can begin when critical patients arrive at the door. Initiate in Minutes Designed to facilitate initiation in a busy critical care environment, targeted temperature management begins with just two buttons, quickly and easily. Without delay and without the risks associated with invasive cooling methods.

4 Intuitive Touchscreen Designed to be easy to read and use, the touchscreen allows you to quickly select your therapy and touch Start. Once you ve initiated, the system gets to work immediately to reach the prescribed temperature so you can tend to your critical patient s needs. Precision Targeting Hypothermia Case Every second during therapy, the Arctic Sun Temperature Management System monitors patient temperature against your target, making microadjustments to the water temperature 30x/hr to ensure the therapy is delivered to your protocol. Normothermia Case

5 Touchscreen Features Treatment Consistency Stores and operates hospital-specific protocols On-Screen Troubleshooting Comprehensive clinician alerts/safeguards Patient Trend Indicator Instant status graph provides real-time updates of therapy Therapy Case Management Access the last 10 cases via USB port Simplified Rewarming Following a cooling procedure, clinicians can easily initiate rewarming therapy User Localization Console instructions in 15 languages Trend Indicator: If arrows are going up, the patient is generating heat. Access pre-programmed protocols and simply touch Start. Rewarming is easily initiated after the cooling phase is complete.

6 Advanced Thermal Transfer The patented ArcticGel Pads are the key component that sets the Arctic Sun Temperature Management System apart from other cooling methods. The pads feature a thin hydrogel coating that ensures they maintain contact with the patient s skin throughout the treatment. The conductive properties of the pads mimic water immersion. 1

7 The ArcticGel Pad Patented Three-Layer Construction Hydrogel ensures constant and direct contact between the pad and the skin, a thin film layer optimizes the thermal exchange of water, and the insulating layer prevents thermal loss to the environment Rapid Patient Access Pads allow for full access to groin and chest Leak Proof Technology If punctured, pads will not leak Patient Compatibility ph-neutral and safe for MRI, CT scan, X-ray, cath lab and defibrillation Nurse-initiated Therapy Pads can be placed in minutes, treatment is automated Non-Invasive Avoids risk of nosocomial infections associated with invasive cooling options Solution for Larger Patients Universal ArcticGel Pad increases body surface area coverage on larger patients 1 English MJ, etal. European Journal of Anesthesiology 2008; 25: ArcticGel Pad Sizing Chart High-density dimpled construction supports heavier patient weight and prevents flow diversion. Insulation Thin film Adhesive (hydrogel) Patented three-layer design of the ArcticGel pads maximizes heat transfer efficiency. XXS XS S M L * cm in Small Medium Add X Large XX 1-2 Small Small Small Universal Universal 62 Pads lb kg cm in XX 66 Small Small Universal X Small Small Large Add 1-2 Universal Pads lb kg *Large kit shown with optional Universal Pad

8 Clinician Support Training shouldn t end with an instruction manual. That s why we ve developed an ongoing, comprehensive support program that s designed by and for clinician experts. This collaborative effort is focused on building and improving quality and expertise for the therapy throughout the hospital. The program is designed to provide Continuous Quality Improvement beyond the sale of the system. More than training. A Lifetime of Support. The Arctic Circle Clinical Resource Program is designed to create in-house expertise on the Arctic Sun Temperature Management System and Targeted Temperature Management. To date, thousands of clinicians have completed The Arctic Circle Clinical Resource Program. These professionals are part of a growing community of experts championing the use of Targeted Temperature Management in their own departments and institutions. Get 24/7 support from clinicians just like you experts who can help troubleshoot and even review cases.

9 Clinical Resource Program A Partnership Designed Around Your Workflow Ongoing support and training is designed to be easy and flexible for busy clinicians On-screen Learning Immediately access on-screen tutorials and checklists directly from the device 24/7 Helpline Staffed by Clinician Experts Not just another call center. Clinicians just like you are ready to offer technical support Customized Case Review Clinician support experts can debrief your last cases to evaluate system performance and help identify continuous quality improvement initiatives

10 Arctic Sun Temperature Management System Therapy Modes Heater Capacity Circulating Fluid Reservoir Capacity Water Flow Rate Patient Probe Type Patient Temperature Inputs Patient Temperature Display Range Patient Temperature Measurement Accuracy Responses of the PCLCS (Physiologic Closed-Loop Control System) Patient Temperature Control Range Water Temperature Display Range Water Temperature Control Range (Manual) High Water Temperature Limit Low Water Temperature Limit Time to heat water from 20 C to 37 C Sound Pressure Mains Input Leakage Current Operating Relative Humidity Range Storage Relative Humidity Range Parameter Normothermia: Control Patient Hypothermia: Cool Patient, Rewarm Patient 2500 BTU per hr / 750 Watts Distilled or Sterile Water 3.5 liters 5 liters per minute YSI 400 Series compatible Patient Temp 1: control, monitor, alarm Patient Temp 2: monitor, alarm 10 C to 44 C 50 F to F 0.1 C / F increments ±0.4 C (10 C to 32 C) ±0.2 C (32 C to 38 C) ±0.4 C (38 C to 44 C) Includes ± 0.1C external probe Settling Time: ~4.5 hrs Relative Overshoot: <0.5 C Command Overshoot: <0.5 C Response Time: Warming (max) 33 C to 37 C: ~6 hrs Cooling 37 C to 33 C: ~2 hrs Steady State Deviation: 0 Tracking Error: 0 Note: All values derived from testing in simulated use. 32 C to 38.5 C 89.6 F to F 0.1 C/ F increments 3 C to 45 C / 37.4 F to F 0.1 C/ F increments 4 C to 42 C / 39.2 F to F 1 C/ F increments 36 C to 42 C / 96.8 F to F 1 C/ F increments 4 C to 25 C / 39.2 F to 77 F 1 C/ F increments 8 minutes (approximate) Alarm Tone: 70dB to 80dB at 1 meter, repeats every 10 seconds Alert Tone: 63dB to 71dB at 1 meter, repeats every 25 seconds Reminder Tone: 65dB at 3 meters, 0.5 seconds on/20 seconds off 115 VAC, 60 Hz, 11.0 Amp (nominal) 230 VAC, 50 Hz, 5.5 Amp <300 μa 5% to 70% non-condensing 5% to 95% non-condensing Operating Temperature Range 10 C to 27 C / 50 F to 80 F Storage Temperature Range -30 C to 50 C / -20 F to 120 F Atmospheric Pressure Range Dimensions Weight ArcticGel Pads Duration Opacity 60 kpa to 110 kpa Height: 35 inches (89 cm) Width: 14 inches (36 cm) Depth: 18.5 inches (47 cm) Empty: 95 lbs (43 kg) ; Filled: 103 lbs (47 kg) Replace pads when hydrogel no longer uniformly adheres to the skin Replacing pads at least every 5 days is recommended Radiolucent & safe for MRI, CT Scan, X-Ray, Cath Lab

11 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM Height 35 89cm Width 14 36cm Depth cm Weight Empty 95 lbs. 43 kg Weight Filled 103 lbs. 47 kg Item Number Description Arctic Sun 5000 Temperature Management System ArcticGel Pad-Extra Extra Small (2 kits/case) ArcticGel Pad-Extra Small (2 kits/case) ArcticGel Pad- Small (2 kits/case) ArcticGel Pad-Medium (2 kits/case) ArcticGel Pad-Large (2 kits/case) ArcticGel Pad-Universal (4 pads/case) ArcticGel Pad-Small Universal (4 pads/case) Calibration Test Unit EXT-Warr-1 EXT-Warr-2 Extended Warranty 1 Year Extended Warranty 2 Year International Devices ARCTIC SUN V ARCTIC SUN 5000 CEU 230V ARCTIC SUN 5000 UK 230V ARCTIC SUN 5000 AUST/N ZEALAND 230V ARCTIC SUN 5000 CHINA 230V

12 Indications for Use: The Arctic Sun Temperature Management System is intended for monitoring and controlling patient temperature. Contraindications: There are no known contraindications. Warnings: When using the Arctic Sun Temperature Management System, note that all other thermal conductive systems, in use while warming or cooling with this device may interfere with patient temperature control. Cautions: Do not place ArcticGel Pads on skin that has signs of ulceration, burns, hives or rash. Caution should be exercised with any patient with a history of skin allergies or sensitivities. 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. Examine the patient s skin under the ArcticGel Pads. Skin injury may occur as a cumulative result of pressure, time and temperature. Carefully remove ArcticGel Pads from the patient s skin at the completion of use. Aggressive removal or removal of cold pads from the patient s skin may result in skin tears. 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. Please consult package insert for more detailed safety information and instructions for use Bard, Arctic Sun, Simply Advanced, and ArcticGel are trademarks and/or registered trademarks of C. R. Bard, Inc. Copyright 2014 C. R. Bard, Inc. All Rights Reserved. For more information: R02/14 THP P02/14 2.5M Manufacturer: Medivance, Inc. 321 South Taylor Ave., Suite 200 Louisville, Colorado USA medivance.com Customer Service Phone: Customer Service Fax: bmd.cs@crbard.com