The 37Company Mistral-Air Series User manual

Original Instructions
Version: INT/R295-EN/10-11/17

User Manual
Mistral-Air® Plus Warming Unit
MA1100-EU (220-240V~, 50/60 Hz)
MA1100-US (110-120V~, 60 Hz)
MA1100-JP (100-110V~, 50/60 Hz)

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Foreword ..................................................................................................3
Disclaimer ................................................................................................3
1 Contra-indications, Safety Precautions, Symbols and Graphics ....4
1.1 Contra-indications ....................................................................4
1.2 Safety Precautions ...................................................................4
1.3 Symbols ...................................................................................7
1.4 Mistral-Air® Graphics .............................................................. 10
2 Indications For Use ......................................................................... 11
3 Temperature Management .............................................................. 11
4 Forced Air Warming ........................................................................ 11
5 Description of Mistral-Air® Plus Warming Unit .............................. 11
5.1 The Appliance ........................................................................ 12
5.2 The Control Panel .................................................................. 13
6 Preparing the Mistral-Air® Plus Warming Unit For Use.................. 13
7 Mounting the Mistral-Air® Plus Warming Unit ................................ 14
8 User Instructions ............................................................................. 15
8.1 Connection to Power Supply .................................................. 15
8.2 Switching the Unit On ............................................................. 16
8.3 Connecting the Blanket .......................................................... 16
8.4 Warming Up With the Mistral-AirÒ Plus Warming Unit ............. 17
8.4.1 Temperature Settings ...................................................... 17
8.4.2 Temperature Selection .................................................... 17
8.5 Stop Warming ........................................................................ 18
9 Safety Systems and Alarms ............................................................ 18
9.1 General Alarms ...................................................................... 19
9.2 Other Safety Features ............................................................ 20
9.3 The Blankets .......................................................................... 21
10 Maintenance .................................................................................... 21
11 Storage and Cleaning ...................................................................... 22
12 Replacing the Filter ......................................................................... 22
13 Reset the Hour Meter ...................................................................... 24
14 Replacing the Hose ......................................................................... 25
15 Replacing the Power Cord .............................................................. 25
16 Parts Replacement .......................................................................... 26
17 Spare Parts and Order List ............................................................. 27
18 Specifications .................................................................................. 28
19 Electromagnetic Compatibility ....................................................... 30
19.1 Electromagnetic Immunity ................................................... 30
19.2 Electromagnetic Emissions ................................................. 31
19.3 Recommended Separations Distances................................ 31
20 Warranty .......................................................................................... 33

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Foreword
Congratulations on your purchase of the Mistral-Air® Plus Forced Air
Warming Unit.
This device was developed with and for users and is built in accordance to
the latest safety standards.
We wish you every success in preventing and controlling hypothermia and
we are sure that the Mistral-AirÒ Plus warming unit can help you to do so.
Please read this manual carefully before using the Mistral-Air® Plus warming
unit.
The 37Company
Disclaimer
The 37Company reserves all rights. No part of this document may be
reproduced or published, electronically, mechanically, in print, photographic
print, on microfilm or by any other means whatsoever, without the explicit
consent of The 37Company.
The content of this document has been compiled with the greatest possible
care and this information can be regarded as reliable. Nevertheless,
The 37Company is not liable for any consequences arising from the use of
the manual.
The 37Company reserves the right to make alterations and improvements to
the device.
The 37Company cannot be held liable for the final outcome of the patients’
treatment.
This document contains proprietary information that may not be disclosed to
third parties. This document may not be used without the explicit written
consent of The 37Company.
These instructions are intended for personnel authorised to work with and/or
service the medical device mentioned in this manual.
Detailed technical information of this device can be found in the separate
technical manual.

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1 Contra-indications, Safety Precautions, Symbols and
Graphics
Your Mistral-Air® Plus warming unit was designed and built with safety in
mind. The unit should provide reliable service and high quality patient care.
However, there is no replacement for care providers being attentive to their
patients’ needs and equipment operation. Read and understand all warnings
and precautions before using or prescribing the Mistral-Air® Plus warming
unit.
1.1 Contra-indications
Do not apply heat directly to open wounds.
Do not apply the warming system to ischemic limbs.
a. Use caution and consider discontinuing use on patients during
vascular surgery when an artery is clamped to an extremity (i.e.
aortic cross-clamping)
b. Use caution and monitor closely if used on patients with severe
peripheral vascular disease
1.2 Safety Precautions
Adequate grounding reliability can only be achieved when the device
is connected to an equivalent receptacle marked ‘hospital grade’.
Avoid direct contact between a blanket and a laser. Although the
blankets are flame retardant per 16 CFR Part 1610 (Standard for the
flammability of clothing textiles) class 1, compliance with ISO
11810:2015 (classification for the laser resistance) is not
demonstrated.
Use of accessories, transducers and cables other than those
specified or provided by The 37Company of this device could result
in increased electromagnetic emissions or decreased
electromagnetic immunity of the Mistral-Air® Plus warming unit and
result in improper operation
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 Mistral-Air® Plus warming
unit, including cables specified by The 37Company. Otherwise,
degradation of the performance of this device could result.

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When replacing the hose, do not touch the temperature sensors. If
these sensors are touched in any way, the unit must be recalibrated.
The Mistral-Air® Plus warming unit is fitted with an air filter; however
airborne contamination shall be taken into consideration when using
the warming system.
In order to prevent the patient from becoming hypothermic due to
unanticipated loss of power, connect the unit to the emergency
mains power.
When the unit is switched off, use of good thermal conductivity
materials on the patient could decrease the patient temperature.
The heating device does not contain an alarm system with an
interruption of power supply/supply mains alarm condition. This
means that in case of a power failure, there will be no alarm.
The unit is not equipped with an isolating switch. Temporary
interruption of the supply mains will render the device in Stand-by
Mode.
The Mistral-Air® Plus warming unit is certified according to IEC
60601-1-2:2014 for electromagnetic interference. However, if
electromagnetic interference with nearby devices is experienced, the
user is encouraged to correct the interference by one or more of the
following measures:
•Isolate the offending device.
•Reorient or relocate the Mistral-Air® Plus warming unit.
•Increase the distance between the interfering device and the
Mistral-Air® Plus warming unit, use another electrical outlet.
•If assistance is required, please contact your local dealer.
Use of Mistral-Air® Plus warming unit adjacent to or stacked with
other equipment should be avoided because it could result in
improper operation. If such use is necessary, the Mistral-Air® Plus
warming unit and the other equipment should be observed to verify
that they are operating normally.
Do not use the Mistral-Air® Plus warming unit with any forced air
disposables other than Mistral-Air® blankets. Thermal injury may
result.
Do not place the unit in or on the bed with the patient.
A physician order is required for setting temperature and for
continued use.

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Neonates and pediatric patients of low weight will have a tendency to
overheat more readily than adults. Failure to monitor core
temperature could result in abnormal elevation of body temperature
resulting in serious injury or death.
If patient temperature is not responding or does not reach prescribed
temperature in prescribed time notify physician.
Place the unit in such way that the mains plug could be disconnected
easily in case of emergency.
Warming transdermal medications (patches) can increase drug
delivery, resulting in possible harm to the patient.
To remove all power from the Mistral-Air® Plus warming unit, the
mains power cord must be removed from the electrical receptacle.
Stay in viewpoint of the user interface when performing the self-test,
and selecting the set-point.
In case of temperature alarm, check for free airflow. Ensure blanket
is not folded and do not place tools/equipment on the blanket which
could result in a blocked air flow. Be sure the air inlet is free. If the
unit continues to alarm, take the unit out of use and contact the
hospital service department or the local supplier.
Mistral-Air® blankets need to be used with the soft blue material
towards the patient’s skin and the white or reflective layer away from
the patient’s skin. The blue side provides the air distribution towards
the patient.
Never fold the blankets during use.
Do not obstruct blanket channels by e.g. instruments/tape/clamps.
Do not return the unit from service without the filter present.
Do not apply the lock screw into the sensor!

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Do not to cover the patient’s thorax during cardioversion or
defibrillation therapy with our Mistral-Air® Blankets.
1.3 Symbols
This paragraph contains a list of official symbols.
IP21
Protected against solid foreign objects of 12 mm Ø and greater.
Protected against vertically falling water drops (according to IEC
60529).
Rx only
Caution: Federal US law restricts this device to sale by or on
order of a physician.
Connect the Mistral-Air® Plus warming unit to an earthed socket
only. Risk of electrical shock exists if the equipment is not
connected to a properly grounded receptacle.
No free hosing. CAUTION! Hose nozzle MUST be connected to a
compatible forced air blanket or thermal injury may occur.
Check patient’s temperature and skin condition at least every 15
minutes, or according to institutional protocol.
Do not apply to patients with ischemic limbs.
Do not use Mistral-Air® Plus warming unit and blankets near
flammable anaesthetics, to avoid the risk of explosion.
Serial number
Catalogue / article number
Sterile, method of sterilisation ethylene oxide
Batch code / lot number
Manufacturer
Transport and storage ambient temperature range

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Transport and storage relative humidity range
Transport and storage atmospheric pressure range
AC voltage
Electrical shock hazard. Do not disassemble the Mistral-Air® Plus
Warming Unit unless you are a qualified service technician. There
are electrically live parts within the unit when it is connected to a
power supply.
Type BF applied parts (according to IEC 60601-1)
Equipotentiality
Expiry date, year/month
For single patient use only. Do not re-use.
Does not contain natural latex components
Transformer fuses (250V 800 mA Fast Acting)
Refer to instruction manual/ booklet
Consult user manual; operating instructions
Alarm indication on control equipment
Urgent alarm indication on control equipment
Caution

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Not for use in MRI
Bell, cancel temporary
Service indicator
Upper limit of temperature
Lower limit of temperature
Non-ionizing electromagnetic radiation

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1.4 Mistral-Air® Graphics
This paragraph contains a list of Mistral-Air® graphics.
Prior to use, the user needs to check that the Mistral-Air® Plus
warming unit (including the power cord and the hose) is
undamaged. In the event of damage do not use the Mistral-Air®
Plus warming unit.
Do not use the Mistral-Air® blankets when damaged.
Maintenance and repairs shall be performed by qualified medical
instrument technicians only.
To keep the Mistral-Air® Plus warming unit stable, the wheelbase
of the stand must be in a particular ratio to the clamp height. See
chapter 7 .
Do not immerse the Mistral-Air® Plus warming unit in fluid. Clean
the appliance with standard cleaning agents. See chapter 11.
S = Small, M = Medium, L = Large, XL = Extra large
All steps are followed according to the manufacturer’s instructions
Make sure the power cord is secured by the cord anchor
Plug the unit into an earthed mains socket
Before using the Mistral-Air® Plus warming unit, it should be
attached to a pole or placed on a table.

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2 Indications For Use
The Mistral-Air® Warming System is a forced air warming device and
comprises of a warming unit and a variety of blankets. It is intended to raise
and maintain patient temperature by means of surface warming.
3 Temperature Management
Hypothermia, an abnormal drop in body temperature, is a threat to human
life. Hospital patients in particular run serious risks if their body temperature
falls below 36 ºC. The risk of hypothermia is particularly high at moments
when they are vulnerable, such as pre-, per-, and post-surgical interventions.
Factors that can contribute to hypothermia include the duration of the
surgical intervention, the location of the wound, the amount of blood loss, the
surface area of the wound, the environmental temperature and the
anaesthetic technique.
4 Forced Air Warming
Forced air warming is a widely used and clinically accepted intervention for
the prevention of hypothermia and/or re-warming of the postoperative
surgical patient. The principle of operation for forced air warming systems is
an electrically powered unit consisting of a fan and heating element that
propels warmed air via a flexible hose to a blanket draped over the patient.
Some configurations allow for the patient to be placed on top of the blanket
or surrounded by a warming tube.
All of these forced air warming systems are intended to distribute warmed air
to the patient in a manner that is safe and effective.
The clinical areas are: operating room, recovery room, anaesthetic room,
intensive care unit, medical/surgical floors and emergency room. Mainly
used during the entire perioperative pathway (pre-, per-, and postoperative
period).
5 Description of Mistral-Air® Plus Warming Unit
The Mistral-Air® Plus warming unit is a system which is intended for use in
preventing patients from becoming hypothermic.
The Mistral-Air® Plus warming unit shall only be used with disposable
Mistral-Air® blankets that are single patient use only.

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5.1 The Appliance
The Mistral-Air® Plus warming unit can be controlled by using the control
panel at the front top of the unit. The clamp to fix the Mistral-Air® Plus
warming unit to a pole is positioned at the back of the unit.
Article number: - MA1100-EU (220-240 V~, 50/60 Hz)
- MA1100-US (110-120 V~, 60 Hz)
- MA1100-JP (100-110 V~, 50/60 Hz)
Control panel
Hose towards
patient/blanket
Handle, at top side
side

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5.2 The Control Panel
The control panel is located at the front top of the unit and may be operated
by pressure sensitive buttons.
The Mistral-Air® Plus warming unit is very easy to use. All settings are visible
on the control panel and you can select the preferred temperature by
pressing the Temperature Selection button.
In emergencies, an audible alarm will be activated and an LED will flash
yellow.
6 Preparing the Mistral-Air® Plus Warming Unit For
Use
Before using the Mistral-Air® Plus warming unit, it should be
attached to a pole or placed on a table.
Prior to use, the user needs to check that the Mistral-Air® Plus
warming unit, the power cord and the hose are undamaged. In the
event of damage do not use the Mistral-Air® Plus warming unit.
Plug the Mistral-Air® Plus warming unit into an earthed socket.
Place the unit in such way that the mains plug can be
disconnected easily in case of emergency.
Stand-by
button / On
Audible
alarm
suppression
button
Temperature
selection button
Service
indicator
Under temp
alarm
Over temp
alarm
Temperature selection
indicator
Fan only /
ambient air
indicator

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The potential equalization plug at the rear of the device can be
connected to the hospital grounding system.
7 Mounting the Mistral-Air® Plus Warming Unit
The Mistral-Air® Plus warming unit must be mounted securely before use.
The Mistral-Air® Plus warming unit can be mounted onto the Mistral-Air®
curved pole with basket (art. MA5100-C). The unit should be clamped onto
the pole at the indentation. Avoid blocking the air inlet (bottom of unit).
It is also possible to place the Mistral-Air® Plus warming unit on a table.
Do not place the unit in or on the bed with the patient
Mistral-Air® curved pole with basket
Art. MA5100-C

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8 User Instructions
When using the Mistral-Air® Plus warming unit, please follow the
instructions below. In each blanket box an instruction for use is added.
Check patient’s temperature and skin condition at least every 15
minutes.
Monitor patient skin routinely, the hospital protocol is always
leading.
Warming transdermal medications (patches) can increase drug
delivery, resulting in possible harm to the patient.
Do not apply to patients with ischemic limbs.
8.1 Connection to Power Supply
a
b
c
d
a. Make sure the power cord is secured by the cord anchor.
b. Plug the unit into an earthed mains socket.
c. The unit automatically switches to Stand-by mode, which is indicated by
the amber Stand-by LED located on the left side of the control panel.
d. The Mistral-Air® Plus warming unit is now in Stand-by mode.
To remove all power from the Mistral-Air® Plus warming unit, the
mains power cord must be removed from the electrical receptacle.

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8.2 Switching the Unit On
a
b
c
a. Activate the Mistral-Air® Plus warming unit by pressing the Stand-by
button. The LED now turns green.
b. The Mistral-Air® Plus warming unit will now perform a self-test, which
includes a flash of all the LED’s and a short audible alarm. When a LED
or the audible beep fails, take the unit out of use for repair.
c. After passing the self-test The Mistral-Air® Plus warming unit will start
blowing air at the default temperature setting of 38 ˚C.
Stay in viewpoint of the user interface when performing the self-test,
and selecting the set-point.
Do not use the Mistral-Air® Plus warming unit without a
Mistral-Air® blanket connected to it. Thermal injury may
result.
8.3 Connecting the Blanket
Take the selected Mistral-Air® blanket out of the package and follow the
instructions on the insert provided with the blanket box.
Place the unit near the hose inlet of the blanket. Insert the end of the
flexible hose into the air inlet port of the Mistral-Air® blanket. Make sure the
hose is fully pushed in.

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8.4 Warming Up With the Mistral-Air
Ò
Plus Warming Unit
8.4.1 Temperature Settings
The four settings are:
• Fan only - Ambient air
• 32 ºC (89.6ºF) - Low temperature
• 38 ºC (100.4ºF) - Medium temperature
• 43 ºC (109.4ºF) - High temperature
8.4.2 Temperature Selection
The Mistral-Air® Plus warming unit will start up with the default temperature
setting of 38 ºC.
By pressing the “–” temperature selection button twice (2x) (fan is selected
and the fan indicator turns green), the Mistral-Air® Plus will activate the unit
to draw in room temperature air and deliver it to the patient via the blanket.
The heater will not be activated.
The air temperature to the patient will depend on ambient conditions and
possible heat from the blower motor.
By pressing the “+” of the temperature selection button the Mistral-Air® Plus
will activate the heater to deliver the set temperature: 32 ºC, 38 ºC or 43 ºC
at the end of the hose.
By pressing the “+” of the temperature selecting button, the temperature
setting increases. This is indicated by a green LED: