advanced targeted temperature management

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CRITICOOL® MINI

ADVANCED TARGETED TEMPERATURE MANAGEMENT

My name is ____ and I’m happy to introduce you to CritiCool MINI.

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© 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential2

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1 https://doi.org/10.1016/j.earlhumdev.2010.05.010 https://www.uptodate.com/contents/clinical-features-diagnosis-

and-treatment-of-neonatal-encephalopathy .

Up to 9%Incidence of neonatal

encephalopathy in term births1

Unfortunately, neonatal encephalopathy is quite common

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6 hoursTherapeutic window in which neuronal cell death

can be slowed by rapidly cooling the infant2

2 Nicholas Hoque, Ela Chakkarapani, Xun Liu, and Marianne Thoresen. “A Comparison of Cooling Methods Used in Therapeutic Hypothermia for Perinatal Asphyxia.” Pediatrics. 2010, 0031–4005.

And treatment needs to happen quickly in order to be effective. Today we’ll show you how

CritiCool MINI makes it easy to take advantage of that short therapeutic window with its

quick set up, ease of use and some other features like portability.

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MANAGING THERAPEUTIC HYPOTHERMIA

has never been easier

• SET

– Select the desired temperature set point

• WRAP

– Apply the CureWrap™ garment

• COOL

– Initiate fast cooling

• REWARM

– Manage controlled rewarming

Therapeutic hypothermia is simplified with CritiCool MINI

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CureWrapCureWrapCureWrapCureWrap™™™™ GarmentGarmentGarmentGarment

CritiCoolCritiCoolCritiCoolCritiCool®®®® MINI Control UnitMINI Control UnitMINI Control UnitMINI Control Unit

CritiCool MINI works in conjunction with a soft CureWrap garment that wraps around the

neonate to effectively transfer energy. Let me show you how easy it is to get started with

CritiCool MINI.

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First, choose a wrap and position the wrap on the bed, and then the patient on the wrap.

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7 © 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential

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Remove thiscap to fill

Remove thiscap to fill

Power switchPower switch

You’ll fill the water tank with sterile or 0.22 filtered water, and press the power button to

turn on CritiCool MINI.

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and then you’ll see that CritiCool MINI automatically carries out a Self-Test to ensure that

everything is working well internally.

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SURFACESURFACE CORECORE

CritiCool MINI uses core and surface temperature probes to keep the patient’s temperature

consistent within 0.3 degrees of your set point temperature. You’re matching colors here as

you plug in your adapter cables or reusable probes – gray to gray for core temperature and

green to green for surface temperature

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Attach the probes to the patient

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Then hook up the wrap to the hoses

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and connect the hoses to the device.

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Press OKPress OK

Now that everything is connected, tap TTM on the startup screen and then OK to get

started. The wrap will fill.

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Once the wrap has filled with water, wrap the patient. You always want the wrap to be

loose.

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Let’s go over the main screen. CritiCool MINI has a default target temperature for the

patient of 33.5 which you can see in the center of the screen. If you wish to change it, press

the set point key.

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You can adjust in 0.1 degree increments using the plus and minus buttons, or 1 degree

increments by touching where you want on the scale.

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When it’s time to rewarm, all you need to do [Start video now]:

is press Menu, then Mode Select,

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then Controlled Rewarming.

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You’ll want to confirm the placement of the core probe in the patient, then press OK, and

now you’re gradually rewarming to the rate chosen in Settings.

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You can rewarm anywhere from 0.05 to 0.5 degrees Celsius per hour. Here’s the Settings

Menu where you could choose a different rewarming step if you wanted to. Once you’ve

set your default, there is no need to do this again.

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If at any time you want to see trends over time, press the graph icon.

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This can be particularly helpful to review at the beginning of a shift.

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CritiCool MINI has another mode called Normothermia Mode that is mainly used when

faster warming is needed. It isn’t designed for patients who have been cooled.

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CUREWRAP™ OFFERS STRONG BENEFITS FOR TEMPERATURE MAINTENANCE

2. Promotes holding of baby – even during cooling

3. Flexibility in wrap design

1. Effective energy transfer and wrap design• Consistent temperature maintenance• Covers up to 85% body surface area

There are quite a few advantages to using CritiCool MINI and the CureWrap

for your HIE babies.

For one, the temperature of the baby will be held consistently within 0.3

degrees of your set point – because temperature maintenance is importance

for your therapy. Because of the surface area coverage we get with the

CureWrap design, mothers can hold their babies – even while cooling – if

that’s part of your protocol.

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UNMATCHED PRECISION: CRITICOOL® MINI

Every 133 millisecondsEvery 133 millisecondsEvery 133 millisecondsEvery 133 milliseconds

The control unit reads the patient’s temperature through specific probes every 133 milliseconds and adjusts temperature as necessary in order to maintain the physician determined pre-set temperature settings.

No other competitive product in the thermoregulation device market does so as frequently.

CritiCool MINI is incredibly precise – taking the core temperature of the patient every 133

milliseconds and adjusting as needed. This is far more precise than other thermoregulation

product on the market.

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CLINILOGGER™ FOR DATA ANALYSIS

Every CritiCool MINI comes with a CliniLogger that records your data. You can access the data whenever you want for analysis or training purposes.

During the case, you can also view trends with the temperature graph.

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SIMPLESIMPLESIMPLESIMPLE• Intuitive touch-screen display • Quick and easy set up • Controlled Rewarming

PORTABLEPORTABLEPORTABLEPORTABLE• Battery operated (up to 1 hour)• Lightweight with small footprint

EFFECTIVEEFFECTIVEEFFECTIVEEFFECTIVE• Precise temperature control as set by the physician (133 ms)• Flexible CureWrap™ design promotes holding of the baby• Pressure relief algorithm• Data at your fingertips using temp graph and CliniLogger™

ADVANCED TEMPERATURE MANAGEMENTwith CritiCool® MINI

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THANK YOU

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CRITICOOL® MINI BUILDS ON THE SUCCESS OF CRITICOOL

• In a study comparing selective head cooling, whole body cooling using a mat, and whole body cooling using a wrap, CritiCool was the only group where target rectal temperatures (Trec) were maintained in the target temperature range.1 The same study found that CritiCool minimizes temperature overshoot during the initiation of cooling and reduces fluctuation in Trecduring the maintenance period of cooling when compared with the two other treatment modalities.1

• The use of therapeutic hypothermia was considered successful in a study of 332 patients in the Netherlands and Flanders, Belgium where CritiCool was used.2

• CritiCool was used to cool infants safely within three hours of birth in a landmark study from 2013 that determined that cooling should be initiated as soon as possible after birth in eligible infants.3

1 1 1 1 Nicholas Hoque, Ela Chakkarapani, Xun Liu, and Marianne Thoresen. “A Comparison of Cooling Methods Used in Therapeutic Hypothermia for Perinatal Asphyxia.” Pediatrics. 2010, 0031-4005.

2 Floris Groenendaal et al. “Introduction of Hypothermia for Neonates with Perinatal Asphyxia in the Netherlands and Flanders” Neonatology. 2013;104: 15-21.

3 Thoresen, Marianne et al. “Time Is Brain: Starting Therapeutic Hypothermia within Three Hours after Birth Improves Motor Outcome in Asphyxiated Newborns.” Neonatology. 2013;104:228-233.

This slide lists some of the key findings from some of the key infant studies with CritiCool.

CritiCool MINI’s user interface and temperature algorithms are very similar to CritiCool’s.

When asked for data on the effectiveness of CritiCool MINI, show this slide.

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CRITICOOL® MINI: COMPACT AND PORTABLE

• A Small Footprint:A Small Footprint:A Small Footprint:A Small Footprint:

– Significantly smaller than nearly all competitive devices

– 1/3 the size and weight of CritiCool

• Lightweight: Lightweight: Lightweight: Lightweight:

– Only 11 kg

• Uninterrupted treatmentUninterrupted treatmentUninterrupted treatmentUninterrupted treatment

– Built-in battery provides up to one hour of continued use when a power supply is unavailable – unmatched in the industry

Featuring all the best of CritiCool with added portability:Featuring all the best of CritiCool with added portability:Featuring all the best of CritiCool with added portability:Featuring all the best of CritiCool with added portability:

This slide highlights some of the key advantages of CritiCool MINI relative to CritiCool.

When asked what are the key differences between CritiCool and CritiCool MINI, show this

slide.

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CUREWRAP™ – PROMOTING SKIN HEALTH

• CureWrap is designed to allows for effective cooling even as patient is repositioned due to the surface area coverage of wrap.

• CureWrap is secured to itself, not the patient.

• CritiCool MINI’s water temperature range may allow for less vasoconstriction as the lower limit is 13°C as compared to 4°C in competitive devices.

• CureWrap offers pressure relief channels that distribute pressure across the wrap.

• CritiCool MINI’s pressure relief algorithm periodically allows water to drain from CureWrap, preventing constant pressure on the patient, and allowing for slight automatic repositioning of patient as the water returns to the wrap.

This slide provides an overview of some of CureWrap’s benefits that help promote skin

health.

This slide is useful when asked about the management of subcutaneous fat necrosis.

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CRITICOOL® MINI FACILITATES MONITORING YOUR PATIENT

• Large Color TouchscreenLarge Color TouchscreenLarge Color TouchscreenLarge Color Touchscreen

– View actual patient temperatures

– View and change Set Point temperature with Set Point Key

• Graphical DisplayGraphical DisplayGraphical DisplayGraphical Display

– View procedure data as a chart

• Mirror patient temperature on bedside monitor Mirror patient temperature on bedside monitor Mirror patient temperature on bedside monitor Mirror patient temperature on bedside monitor

– With built-in Core Out feature

This slide provides an overview of the ease of use with CritiCool MINI.

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With Controlled Rewarming Mode

CONTROL REWARMING WITH EASE

Choose theChoose theChoose theChoose the desired rewarming ratedesired rewarming ratedesired rewarming ratedesired rewarming rate

o Rates available from 0.05 to 0.5°C per hour

o Or use the factory set default: 0.2°C per hour

Initiating Controlled Rewarming is quickInitiating Controlled Rewarming is quickInitiating Controlled Rewarming is quickInitiating Controlled Rewarming is quick

Set Temperature will automatically be adjusted in a Set Temperature will automatically be adjusted in a Set Temperature will automatically be adjusted in a Set Temperature will automatically be adjusted in a stepwise fashion stepwise fashion stepwise fashion stepwise fashion according to the chosen rate of rewarming

This slides shows the Controlled Rewarming-related slides.

On the left, Setting Screen 1, where the rate of rewarming per hour is selected for the

controlled rewarming mode, is shown.

On the right, the mode select screen is shown with Controlled Rewarming highlighted (as it

would once selected).

When asked a question about rewarming, this is a helpful slide.

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CRITICOOL® MINI SCREEN COLORS

This slide shows the screen colors that indicate status:

Left: peach/orange color indicates that the patient is being warmed, and therefore the

water temperature is being warmed

Center: green indicates that the patient is within set point range, and the patient’s

temperature (and water temperature) are being maintained

Right: blue indicates that the patient and water are being cooled

This slide can be helpful if the user asks about the water temperature. The user always has

the ability to see what is happening with the water temperature by noting the color on the

screen.

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PRESSURE RELIEF ALGORITHM

• Initial Phase of Regulation:

– 12 minutes of water flowing

– 1 minute of no water flow

• Steady State:

– 12 minutes of water flowing

– 12 minutes of no water flow

• At Any Point:

– Difference of >0.3°C between Set Point and Core Temperature will cause water to flow back into the wrap

This slide explains the pressure relief algorithm that periodically allows water to drain from

the wrap.

When you get questions about pressure sores, subcutaneous fat necrosis or other skin-

related questions, it’s helpful to explain our pressure relief algorithm.

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CORE OUT (TEMPERATURE SPLITTER)

CritiCool MINI has a built in temperature splitter, which allows you to share the patient’s

core temperature from your Belmont temperature management system with an external

monitor.

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Screen #1 – General Settings Screen #2 – Setting Alarm Limits

SETTINGS SCREEN

This screen shows settings screens 1 and 2.

When questions about adjusting settings (set points, alarms, etc.) arise, this is a helpful

slide to show.

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advanced targeted temperature management

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