701-00372 Rev A
CRITICOOL® MINI
ADVANCED TARGETED TEMPERATURE MANAGEMENT
My name is ____ and I’m happy to introduce you to CritiCool MINI.
1
© 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential2
701-00380 Rev A
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
2
© 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential3
701-00380 Rev A
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.
3
© 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential4
701-00380 Rev A
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
4
© 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential5
701-00380 Rev A
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.
5
© 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential6
701-00380 Rev A
First, choose a wrap and position the wrap on the bed, and then the patient on the wrap.
6
7 © 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential
701-00380 Rev A
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.
7
8 © 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential
701-00380 Rev A
and then you’ll see that CritiCool MINI automatically carries out a Self-Test to ensure that
everything is working well internally.
8
9 © 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential
701-00380 Rev A
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
9
© 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential10
701-00380 Rev A
Attach the probes to the patient
10
© 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential11
701-00380 Rev A
Then hook up the wrap to the hoses
11
© 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential12
701-00380 Rev A
and connect the hoses to the device.
12
© 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential13
701-00380 Rev A
Press OKPress OK
Now that everything is connected, tap TTM on the startup screen and then OK to get
started. The wrap will fill.
13
© 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential14
701-00380 Rev A
Once the wrap has filled with water, wrap the patient. You always want the wrap to be
loose.
14
© 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential15
701-00380 Rev A
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.
15
© 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential16
701-00380 Rev A
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.
16
© 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential17
701-00380 Rev A
When it’s time to rewarm, all you need to do [Start video now]:
is press Menu, then Mode Select,
17
© 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential18
701-00380 Rev A
then Controlled Rewarming.
18
© 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential19
701-00380 Rev A
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.
19
© 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential20
701-00380 Rev A
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.
20
© 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential21
701-00380 Rev A
If at any time you want to see trends over time, press the graph icon.
21
© 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential22
701-00380 Rev A
This can be particularly helpful to review at the beginning of a shift.
22
© 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential23
701-00380 Rev A
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.
23
24 © 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential
701-00380 Rev A
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.
24
© 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential25
701-00380 Rev A
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.
25
© 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential26
701-00380 Rev A
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.
26
© 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential27
701-00380 Rev A
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
27
© 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential29
701-00380 Rev A
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.
29
© 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential30
701-00380 Rev A
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.
30
© 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential31
701-00380 Rev A
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.
31
© 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential32
701-00380 Rev A
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.
32
© 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential33
701-00380 Rev A
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.
33
© 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential34
701-00380 Rev A
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.
34
35 © 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential
701-00380 Rev A
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.
35
36 © 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential
701-00380 Rev A
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.
36
© 2021 BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential37
701-00380 Rev A
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.
37