INT-R778-EN-6-08-19 MA1200-xx Mistral-Air-User Manual English

User Manual
Forced Air Warming Unit
Original instructions
Version: INT/R778-EN/6-08/19
This page intentionally left blank!
Contents
1 General information..................................................................................................................... 5
1.1 About this manual.................................................................................................................. 5
1.2 Indications for use..................................................................................................................5
1.3 Contact................................................................................................................................... 5
1.4 FAQ and training....................................................................................................................5
1.5 Warranty................................................................................................................................. 6
1.6 Authorisation of personnel..................................................................................................... 6
1.7 Warning, caution and note.....................................................................................................6
1.8 Disclaimer and intellectual property statement...................................................................... 6
2 Contraindications, warnings, cautions, notes and symbols................................................... 8

2.1 Contra-indications...................................................................................................................8
2.2 Warnings.................................................................................................................................8
2.3 Cautions................................................................................................................................10
2.4 Notes.................................................................................................................................... 11
2.5 Device safety symbols......................................................................................................... 11
2.6 Blanket safety symbols........................................................................................................ 14
3 Description..................................................................................................................................17
3.1 Overview of the Mistral-Air® Warming Unit (MA1200).........................................................17
3.2 Overview of the Mistral-Air® Warming Unit (MA1200-QC).................................................. 18
3.3 Overview of the control panel.............................................................................................. 18
3.4 Visual and audible warning systems....................................................................................19
3.4.1 Technical alarm............................................................................................................ 19
3.4.2 Overtemperature alarm................................................................................................ 20
3.4.3 Microcontroller watchdog alarm................................................................................... 20
3.4.4 Filter replacement indicator.......................................................................................... 21
3.4.5 Temporarily audible alarm suppression....................................................................... 21
4 Accessories and disposables...................................................................................................22

4.1 Mistral-Air® Adjustable Pole (MA5200)................................................................................23
4.2 MA1200 mounting parts (MA5002)...................................................................................... 25
4.3 Mistral-Air® QC Hose - (MA1200-1018) and QC Hose XL (MA1200-1018XL).................... 26
4.4 Mistral-Air® blankets............................................................................................................ 26
5 Set up.......................................................................................................................................... 27
5.1 Transport and storage..........................................................................................................27
5.2 Connecting the power supply cord...................................................................................... 27
5.3 Attaching the mounting parts............................................................................................... 27
6 Operation.....................................................................................................................................31
6.1 Safety instructions before operation.................................................................................... 31
6.2 Connecting the Mistral-Air® QC Hose (MA1200-1018 & MA1200-1018XL) to the
device....................................................................................................................................... 31
User Manual - Contents 3 of 48

6.3 Connecting the power supply.............................................................................................. 31
6.4 Connecting the blanket........................................................................................................ 32
6.5 Turning on the device.......................................................................................................... 32
6.6 Selecting the temperature.................................................................................................... 32
6.7 Stopping warming.................................................................................................................33
7 Maintenance................................................................................................................................ 34
7.1 Cleaning................................................................................................................................35
7.2 Corrective maintenance....................................................................................................... 35
7.2.1 Replacing the Mistral-Air® Filter (MA1200-1001).........................................................35
7.2.2 Replacing the Mistral-Air® Hose (MA1100-1018 & MA1100-1018XL)......................... 37
7.2.3 Replacing the Mistral-Air® QC Hose (MA1200-1018 & MA1200-1018XL)................... 39
7.2.4 Replacing the power cord............................................................................................ 40
8 Troubleshooting......................................................................................................................... 42
9 Specifications............................................................................................................................. 43
9.1 Specifications of the device................................................................................................. 43
10 Electromagnetic compatibility................................................................................................ 45
10.1 Electromagnetic immunity.................................................................................................. 45
10.2 Electromagnetic emissions.................................................................................................46
10.3 Recommended separation distances................................................................................. 47
User Manual - Contents 4 of 48

1 General information
1.1 About this manual

In this manual, you can find important information about how to operate the Mistral-Air® Warming
Unit MA1200 - (MA1200- EU/US) and the Warming Unit MA1200-QC - (MA1200-QC- EU/US)
(hereafter referred to as ‘the device’).
The manual helps you with the operation and the maintenance of the device, in a safe and
responsible manner.
Read this manual carefully. Complete all the procedures. Do the procedures in the given
sequence. Always keep the manual near the device.
Please refer to the Mistral-Air® technical manual for maintenance, repair and calibration
instructions. The Mistral-Air® technical manual is available for download at the business partner
menu of the The 37Company website.
1.2 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.
1.3 Contact
The Surgical Company International B.V. doing business as The 37Company:
The 37Company
Beeldschermweg 6F
NL-3821 AH Amersfoort
The Netherlands
Tel: +31 (0)33 450 72 50

Fax: +31 (0)33 450 72 60
E-mail: [email protected]
Website: www.the37company.com
Refer to the website for local distributors.
1.4 FAQ and training

Please refer to our website (www.the37company.com/faq) for an up-to-date overview of the
frequently asked questions of the Mistral-Air® products.
User Manual - General information 5 of 48

Warning!
The device may only be operated by trained clinicians and maintenance may only be
performed by trained biomedical technicians or engineers. Both user groups must be
trained by certified trainers from your local distributor. These trainers will be trained and
certified by specialists of The 37Company.
1.5 Warranty
For the warranty provisions, refer to the website: http://www.the37company.com.
1.6 Authorisation of personnel

The instructions contained in this manual are solely intended for authorised and certified personnel
to work with and/or service the medical device(s) described herein.
1.7 Warning, caution and note
Warning!
A "warning" tells you that there is a risk of personal injury or death.
Caution!
A "caution" tells you that:
• there is a risk of damage to the device, and/or
• there is a risk of damage to other equipment.
A "note" provides more information.
1.8 Disclaimer and intellectual property statement

For the avoidance of doubt, the information and/or instructions mentioned in this manual do not
contain and may not be construed as containing any advice regarding a medical treatment in
the broadest sense of the term. This manual is provided for general informational/educational
purposes and is meant as a guideline for the proper usage of the medical device(s) in question.
Accordingly, before taking any actions based on this manual, the user shall be obliged to consult
with the appropriate medical and healthcare professionals such as the trained and certified
clinicians mentioned under paragraph FAQ and training on page 5 of this manual. The use or
reliance of any information contained in this manual as medical advice is and shall solely remain at

the user’s risk. The 37Company cannot be held liable for the outcome of a patients’ treatment with
the use of the medical device(s) described herein.
The description and instructions regarding the medical device(s) mentioned in this manual have
been compiled with the greatest possible care. Nonetheless, the user should be aware that
The 37Company can and may have made certain alternations and/or improvements regarding
these medical device(s) which may not yet be adequately described in the current copy of the
manual. All users are therefore strongly advised to make sure that they consult the most recent
version of the manual. The updated manuals are available for download at the The 37Company
website: www.the37company.com.
This manual contains proprietary information of The 37Company and all data mentioned herein
are protected by copyright and patent laws and any other applicable statutory provisions regarding
the protection of intellectual property, and may therefore not be reproduced, republished,
disclosed to third parties, transmitted, displayed, broadcast or otherwise exploited in any manner
whatsoever without the explicit prior written consent of The 37Company. The name and logo of
The 37Company and all related trademarks, trade names, and other intellectual property are and
shall remain the exclusive property of The 37Company and cannot be used without the latter’s
express prior written consent.
The original instructions of this document are created in English. All other language versions are
translations of the original instructions. In the event of ambiguity and/or disputes, the English text
always takes precedence.

2 Contraindications, warnings, cautions, notes and
symbols
The device was designed and built with safety in mind. However, there is no replacement for care
providers being attentive to their patients’ needs and equipment operation. Read and understand
the contraindications, warnings, cautions and notes before using the device.
2.1 Contra-indications
• Only apply heat to intact skin and do not apply heat directly to open wounds.
• Do not apply the warming system to ischemic limbs.
1. Use caution and consider discontinuing use on patients during vascular surgery when an
artery is clamped to an extremity (i.e. aortic cross-clamping).
2. Use caution and monitor closely if used on patients with severe peripheral vascular
disease.
2.2 Warnings
Warning!
• Do not use the device when it is damaged or when the Mistral-Air® Blanket is damaged.
Thermal injury may result.
• Do not allow the patient to lie on or contact the hose with the skin when the device is
active. Thermal injury may result.
• Do not use the Mistral-Air® Blanket to transfer or move the patient. Injury to the patient
may result.
• To prevent tipping when mounting to an IV-pole, mount the device at a height at which
the IV-pole is stable. Injury may occur. Before usage, assess the stability by placing the
IV-pole on a surface at an angle of 10° from the horizontal plane with brakes activated.
The IV-pole may not overbalance, or move. Also passing over a 10 mm threshold may
not result in overbalancing. Mass and position of center of gravity are provided in this
IFU for theoretical analysis. The 37Company cannot provide maximum mounting height
prescriptions for different wheel base diameters, numbers of castors (either with brakes
or not) and configurations of other equipment mounted to the IV pole.
• Do not use the device without a Mistral-Air® Blanket connected to it (no free hosing).
• Do not use the device and blankets near flammable anesthetics and/or in oxygen-
enriched environment, to avoid the risk of explosion or fire.
• Check patient’s temperature and skin condition at least every 15 minutes, or according
to institutional protocol.
• Do not cover the patient’s thorax with our Mistral-Air® Blankets during cardioversion or
defibrillation therapy.
• Applying air with a temperature above the normothermic core body temperature range
(36 – 37.5°C) incorporates the risk of hyperthermia. Depending on the selected set
User Manual - Contraindications, warnings, cautions, notes and

symbols 8 of 48
point, heating time, additional heat sources and insulation, the patient’s body core
temperature can rise above 37.5°C. Thermal injury may result.
• Pediatric patients of low weight will have a tendency to overheat more rapidly than
adults. Failure to monitor core temperature could result in abnormal elevation of body
temperature resulting in serious injury or death.
• A physician order is required for setting temperature and for continued use.
• If patient temperature is not responding to treatment or does not reach the desired
temperature, notify a physician.
• Warming transdermal medications (patches) can increase drug delivery, resulting in
possible harm to the patient.
• Do not use the device with any forced air disposables other than Mistral-Air® Blankets.
• 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.
• Never fold the blankets during use. This could lead to insufficient treatment.
• Do not obstruct blanket channels by e.g. instruments/tape/clamps. This could lead to
insufficient treatment.
• The device is fitted with a HEPA H13 class air filter (EN1822-1:2009, GROUP H).
However airborne contamination should be taken into consideration when using the
warming system to minimize the risk of infection for the patient.
• Before you clean the device, disconnect the power supply cord to eliminate the risk of
electrocution.
• Clean the hose after each use to reduce the risk of infection.
• When replacing the hose, do not touch the temperature sensors. If these sensors are
touched in any way, they can be damaged and out of calibration. This could cause
burns to the patient. If the temperature sensors are touched or damaged, perform
the after-service test protocol after replacing the hose (see Mistral-Air® Warming Unit
Technical Manual).
• Use of accessories, transducers and cables other than those specified or provided by
The 37Company of this equipment could result in increased electromagnetic emissions
or decreased electromagnetic immunity of this equipment and result in improper
operation.
• Do not disassemble the device unless you are a qualified service technician. Injury may
occur.
• Before performing corrective maintenance (see Corrective maintenance on page 35),
disconnect the power supply cord to eliminate the risk of electrocution. There are
electrically live parts within the device when it is connected to a power supply.
• To attach the (optional) Mistral-Air® QC Hose - (MA1200-1018) or QC Hose XL -
(MA1200-1018XL) with a quick connector, firmly press the hose connector into the unit
until a "click" is produced. Check to ensure the connector is securely locked on the
device (MA1200-QC only).

symbols 9 of 48
• Mistral-Air® blankets need to be used with the soft blue material towards the patient’s
skin. When used oppositely the treatment will be ineffective. The blue side provides the
air distribution towards the patient.
• When placing the device on a surface, make sure the surface is horizontal, solid and
clean. Do not place the device on a carpet because it could block the air inlet and
reduce the performance.
• When using bed hooks, only mount the device to a horizontal secured surface. Do
not mount the device to a tilting non-secured surface. The device may fall and pull the
blanket from the patient.
• Do not place the device above, or in the bed with the patient. Thermal injury may occur.
• Place the device in such a way that the mains plug can be disconnected easily in case
of emergency. Operator injury may occur.
• Connect the device to an adequate reliable grounded receptacle. Operator injury may
result.
• When mounted to the Mistral-Air® Adjustable Pole, make sure that the hose does not
extend beyond the wheelbase of the Mistral-Air® Adjustable Pole so that it is protected
by the wheelbase. Otherwise damage to the hose may occur.
• Clean the hose at ambient temperature and make sure the hose is dry before use.
Damage to the hose or device may occur.
• When the device has suffered impact, disconnect the power plug and perform the
after service test protocol before returning the device for clinical use (see Mistral-Air®
Warming Unit Technical Manual). Otherwise injury may occur.
• Do not position the device close to the patient's head if inhaler therapy is used on the
intensive care.
2.3 Cautions
Caution!
• Do not use a sharp object to press the buttons on the control panel.
• The device must be mounted securely, or placed on a stable flat surface before use to
prevent the device from falling.
• To ensure stability when mounted to a trolley the device may only be mounted to a
Mistral-Air® Adjustable Pole (MA5200).
• Do not immerse the device in liquids. Otherwise, the device can be damaged.
• Stay in viewpoint of the control panel when the device is performing the self-test and
selecting the set-point. See Turning on the device on page 32.
• In case of an alarm, check for any obstruction of the air flow; ensure that the blanket and
the hose are not folded, the inlet is free (not blocked) and no tools/equipment are placed
on the blanket. If the device continues to alarm, take the device out of use and contact
the hospital service department or the local supplier.
• Do not place the device on a carpet because it could block the air inlet and reduce the
performance.

symbols 10 of 48
2.4 Notes
• 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 device is not equipped with an isolating switch. Temporary interruption of the supply
mains will render the device in standby mode and discontinue treatment.
2.5 Device safety symbols

This section contains a list of symbols used for the Mistral-Air® Forced Air Warming Unit.
Protected against ingress of solid objects larger than 12.5 mm and water falling as
a spray at an angle up to 60° from the vertical axis (according to IEC 60429).
Caution: Federal US law restricts this device to sale by or on order of a physician.
Connect the device to an earthed socket only. Risk of electrical shock exists if the
equipment is not connected to a properly grounded receptacle.
No free hosing.
Warning!
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.
Warning!
Do not use the device distal to arterial cross clamping or with a patient with
an ischemic limb.
Serial number

symbols 11 of 48
Catalogue / article number
Manufacturer
Transport and storage ambient temperature limits
Transport and storage relative humidity limits
Transport and storage atmospheric pressure limits
AC voltage
Type BF applied parts (according to IEC 60601-1:2005+A1:2012)
Equipotentiality
Read the user manual.
Consult the instructions for use.

symbols 12 of 48
CE marking of conformity
Dispose according to European Community Directive 2002/96/EC (WEEE).
Caution. Consult the instructions for use for important cautionary.
Low priority alarm indication on control equipment
Medium priority alarm indication on control equipment
Temporarily audible alarm suppression
Repair is required.
Upper limit of temperature, overtemperature alarm
Replace filter.
Air flow at ambient temperature (not heated)
32°C Air flow setpoint at a temperature of 32°C (heated)

symbols 13 of 48
Prior to use, the user needs to check that the device (including the power cord and
the hose) is undamaged. In the event of damage do not use the device.
Maintenance may be only performed by trained biomedical technicians or

engineers only. Both user groups must be trained by certified trainers from
The 37Company or by certified business partners of The 37Company.
Warning!
Plug the device into an earthed mains socket.
Before using the device, it should be attached to a pole, Mistral-Air® Adjustable

Pole (MA5200), bed rail/end, ISO rail, wall, or placed on a table.
2.6 Blanket safety symbols

This section contains a list of symbols used for the Mistral-Air® Blankets.
Not for use in magnetic resonance imaging (MRI)
Caution: Federal US law restricts this device to sale by or on order of a physician.
Do not use the device if the package is damaged.
Catalogue / article number

symbols 14 of 48
Sterile, method of sterilisation ethylene oxide
Batch code / lot number
S = Small, M = Medium, L = Large, XL = Extra large
Manufacturer
Check patient’s temperature and skin condition at least every 15 minutes, or

according to institutional protocol.
Warning!
Do not use the device distal to arterial cross clamping or with a patient with
an ischemic limb.
Transport and storage ambient temperature range
Transport and storage relative humidity range
Transport and storage atmospheric pressure limitation
Expiry date, year/month

symbols 15 of 48
For single patient use only. Do not re-use.
Not made with natural rubber latex.
Read the user manual.
Consult the instructions for use.
CE marking of conformity
Caution. Consult the instructions for use for important cautionary.

symbols 16 of 48
3 Description
3.1 Overview of the Mistral-Air® Warming Unit (MA1200)

The device is a Forced Air Warming Unit which consists of a fan, heater, electronics and a filter to
propel filtered and heated air to a blanket. The device may only be used with disposable Mistral-
Air® blankets that are single use only.
1. Control panel
2. Mounting clamp
3. Mounting options
(accessory)
4. Appliance inlet
5. Equipotential pin
6. Data connection
7. Mains cover
8. Filter (air inlet)
9. Hose
The device can be controlled by using the control panel at the front top of the device. The back of
the device is equipped with a universal mounting clamp, a sealed data connector, an appliance
inlet and an equipotential pin. The air flow output is by default set to normal and can be adjusted
by the technical department to a low fan duty cycle, resulting in 10% lower air flow output. It can be
expanded with a mounting accessory set as shown in the image above to offer various mounting
options, see Accessories and disposables on page 22.
For more device specifications, see Specifications on page 43.
User Manual - Description 17 of 48

3.2 Overview of the Mistral-Air® Warming Unit (MA1200-QC)
1. Control panel
2. Mounting clamp
3. Mounting options
(accessory)
4. Appliance inlet
5. Equipotential pin
6. Data connection
7. Mains cover
8. Filter (air inlet)
9. Removable hose
3.3 Overview of the control panel

The control panel is located at the front top of the device and can be operated by pressure
sensitive buttons. The device is easy to use. All settings are visible on the control panel and you
can select the preferred temperature by pressing the temperature selection buttons. When an
alarm condition is detected, an audible alarm will be activated and an alarm LED will flash yellow.
1. Standby button
2. Temperature selection indicators
3. Overtemperature alarm LED
4. Technical alarm LED
5. Filter replacement indicator LED
6. Temperature selection + and –
buttons
7. Fan only/ambient air indicator
8. Temporarily audible alarm
suppression button

3.4 Visual and audible warning systems
The device is equipped with visual and audible warning systems to protect against excessive
temperatures, to warn for a technical malfunction, and to indicate that filter change is required.
If equipment errors occur, an audible alarm sounds and the relevant LED indicator(s) on the control
panel will flash or light up continuously.
There are four different alarms/indicators:
• Technical alarm
• Overtemperature alarm
• Microcontroller watchdog alarm
• Filter replacement indicator
These alarms/indicators are described in the sections below. It is also possible to temporarily
suppress the audible alarm.
Alarm/indicator summary
Alarm/indicator Priority Behavior
Technical alarm Medium Technical alarm LED: Yellow flashing
Audible alarm: 3 beeps repeated

every 6 seconds
Overtemperature alarm Medium Technical alarm LED: Yellow flashing
Overtemperature alarm LED: Yellow

flashing
Audible alarm: 3 beeps repeated

every 6 seconds
Microcontroller watchdog alarm Medium Technical alarm LED: Yellow

continuous
Overtemperature alarm LED: Yellow

flashing
Audible alarm: continuous beep
Filter replacement indicator Low Filter replacement indicator LED:

Yellow continuous
Audible alarm: 1 short beep
3.4.1 Technical alarm

A flashing yellow technical alarm LED indicates that a technical error has occurred and the air
temperature cannot be accurately controlled. The visual alarm is accompanied by an audible
alarm, which consists of three pulses of 200 ms duration, with 200 ms spacing between each
pulse. This pattern is repeated every 6 seconds.
Some possible causes of this alarm:

• The leads to the temperature sensors are damaged, or disconnected.
• The fan is blocked, or damaged and cannot reach its desired speed.
• The heater is damaged and the desired air temperature is not reached.
• A mains power dip (≥ 30%) occurred for more than 1/60 seconds.
If this alarm occurs, the heater and fan are turned off and the device enters standby mode. It is
impossible to start the device by pushing the standby button. Control of the device can only be
recovered through resetting the device. To do this, disconnect the mains plug and reconnect it.
Caution!
If this alarm occurs, check for anything blocking the air flow path. If the technical alarm
continues, take the device out of use and contact the hospital service department or the
local supplier.
3.4.2 Overtemperature alarm

The overtemperature alarm is triggered with a maximum air temperature of 56°C.
When the overtemperature alarm occurs, the technical and overtemperature LED's flash yellow.
These indicate that the air temperature is too high. The visual alarms are accompanied by an
audible alarm, which consists of three pulses of 200 ms duration, with 200 ms spacing between
each pulse. This pattern is repeated every 6 seconds.
If this alarm occurs, the heater and fan are turned off and the device enters standby mode. It is
impossible to start the device by pushing the standby button. Control of the device can only be
recovered through resetting the device. To do this, disconnect the mains plug and reconnect it.
Caution!
If this alarm occurs, check for anything blocking the air flow path. Ensure that the blanket is
not folded and do not place tools/equipment on the blanket which could result in a blocked
air flow. Ensure that the air inlet is free. If the overtemperature alarm continues, take the
device out of use and contact the hospital service department or the local supplier.
3.4.3 Microcontroller watchdog alarm

The microcontroller watchdog alarm is visually indicated by a continuous yellow technical alarm
LED and a flashing yellow overtemperature LED. The visual alarms are accompanied by a
continuous single tone audible alarm.
The microcontroller watchdog alarm indicates a technical malfunction and is triggered when the
microcontroller is not functioning properly. If this alarm occurs, the heater and fan are turned off
and the device enters standby mode. It is impossible to start the device by pushing the standby
button. Control of the device can only be recovered through resetting the device. To do this,
disconnect the mains plug and reconnect it.
Caution!
If this alarm occurs, send the device to a certified service department for technical support.

3.4.4 Filter replacement indicator
When the yellow filter replacement LED lights up, the filter needs to be replaced. This LED is
activated when the device has been used for more than 2000 hours. When it is activated, it is
accompanied by a single beep.
Refer to Replacing the Mistral-Air® Filter (MA1200-1001) on page 35 for the filter replacement
procedure.
3.4.5 Temporarily audible alarm suppression

The audible alarm may be suppressed for up to 2 minutes by pressing the temporarily audible
alarm suppression button.
When the audible alarm is suppressed, the orange LED lights up. After 2 minutes or after pushing
the button once again, the audible alarm will automatically be restored.

4 Accessories and disposables
The device can be used with the following accessories and disposables:
• Mistral-Air® Adjustable Pole (MA5200)
• MA1200 mounting parts (MA5002)
• Mistral-Air® QC Hose - (MA1200-1018) and QC Hose XL - (MA1200-1018XL)
• Mistral-Air® blankets
Warning!
• Do not place the device above, or in the bed with the patient. Thermal injury may occur.
• When placing the device on a surface, make sure the surface is horizontal, solid and
clean. Do not place the device on a carpet because it could block the air inlet and
reduce the performance.
• The device must be mounted securely, or placed on a stable flat surface before use to
prevent the device from falling.
• To prevent tipping when mounting to an IV-pole, mount the device at a height at which
the IV-pole is stable. Injury may occur. Before usage, assess the stability by placing the
IV-pole on a surface at an angle of 10° from the horizontal plane with brakes activated.
The IV-pole may not overbalance, or move. Also passing over a 10 mm threshold may
not result in overbalancing. Mass and position of center of gravity are provided in this
IFU for theoretical analysis. The 37Company cannot provide maximum mounting height
prescriptions for different wheel base diameters, numbers of castors (either with brakes
or not) and configurations of other equipment mounted to the IV pole.
The image below shows the position of the center of gravity in relation to the center of
the pole clamp.
In the standard configuration, the device can be mounted to an IV pole or ISO rail using the
universal clamp on the back of the device (see figures below). It is also possible to place the
device on a table without reducing the air flow rate.
User Manual - Accessories and disposables 22 of 48

4.1 Mistral-Air® Adjustable Pole (MA5200)
Caution!
When mounting the device to the Mistral-Air® Adjustable Pole, make sure that the hose is
protected by the wheelbase of the trolley. Otherwise, damage to the hose may occur after
impact.

Warning!
Do not mount the device on the extendable, smaller
diameter, part of the trolley's pole. Only mount the
device on the non-extendable part of the trolley's pole
(the lower part).
Mount the device here.
The device can be mounted onto the Mistral-Air® Adjustable Pole (MA5200):

4.2 MA1200 mounting parts (MA5002)
Warning!
• When using bed hooks, only mount the device to a horizontal secured surface. Do
not mount the device to a tilting non-secured surface. The device may fall and pull the
blanket from the patient.
The device has various mounting options using the versatile Mistral-Air® mounting accessory set.
See Attaching the mounting parts on page 27 for more details about attaching the mounting
parts.
Mounting on a bed rail/end using the bed hooks.
Quick-release mechanism to switch between

mounting to bed rail/end and pole.

Mounting on a wall using the Wall mount.
Release by using the quick-release mechanism.
4.3 Mistral-Air® QC Hose - (MA1200-1018) and QC Hose XL

(MA1200-1018XL)
The Warming Unit MA1200-QC has quick-connect functionality to easily replace hoses. Two types
of QC (Quick Connect) hoses are available:
• QC Hose - (MA1200-1018); 1.8m hose length
• QC Hose XL - (MA1200-1018XL); 3m hose length
4.4 Mistral-Air® blankets
Warning!
• Do not use the device with any forced air disposables other than Mistral-Air® Blankets.
• Do not cover the patient’s thorax with our Mistral-Air® Blankets during cardioversion or
defibrillation therapy.
• 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.
The Mistral-Air® blanket range consists of the following categories:

• Mistral-Air® Blankets Plus
• Mistral-Air® Premium Blankets
• Mistral-Air® Specialty Blankets
• Mistral-Air® Warming Suits
Please refer to the Blanket manual (INT/R709-WO/x-xx/xx Mistral-Air Blankets) or the website of
The 37Company (www.the37company.com) for a description of the individual blankets.

5 Set up
5.1 Transport and storage

Store the device and accessories according to the transport and storage recommendations. See
Specifications on page 43.
5.2 Connecting the power supply cord
1. Remove the mains cover using a 4 mm hex key.

2. Attach the C13 plug of the power supply cord.
3. Reattach the mains cover to lock the C13 plug by tightening
the 4 mm hex screw with a maximum torque of 1.5 ± 0.2
Nm.
5.3 Attaching the mounting parts

The MA1200 mounting parts set consists of the following parts:
• 1x Wall mount
• 1x Cover
• 2x Handle
• 1x Cover plate
• 2x Bed support knobs
• 5x M6 x 6 Button head 4 mm hexagon screw
• 5x M4 x 16 Low Cylindrical head 3 mm hexagon screw
• 2x DELTA PT Torx 20IP screw 40 x 16
Caution!
Be careful not to scratch the front of the device.
1. Disconnect the device from the mains socket.

2. Place the device face-down on a soft surface.
User Manual - Set up 27 of 48

3. Remove the 4 M5 screws of the pole clamp using a 4 mm
hexagon key and remove the pole clamp.
4. Attach the Cover at the 3 indicated locations using the first

3 of the 5 M4x16 3 mm hexagon screws with a maximum torque
of 1.5 ± 0.2 Nm.
If you do not attach the Handles mentioned in the step

below, you still need to tighten the last 2 of the 5 M4x16
3 mm hexagon screws.
5. Optional: Click the Handles into the sliders of the Cover and
tighten them at the 2 indicated locations using the last 2 of the
5 M4x16 3 mm hexagon screws.
Warning!
If the Handles are attached, always attach the Bed
support knobs for stability (see step 6).
6. Optional: Attach the 2 Bed support knobs using the 2 Torx

screws. Tighten the screws until the Bed support knobs cannot
be rotated anymore.

7. Optional: Mount the Wall mount and Cover plate to a wall
using wall screws and plugs specifically designed for the used
wall material (not supplied). First check the adequacy (of the
surface) of the structure to which the wall mount will be attached
based on the mass of the device (see Specifications of the
device on page 43) and the center of gravity shown below.
Caution!
Use screws with a diameter which is small enough
(max. M6) not to damage the threads of the Cover plate
holes.
It is advised to account for the readability of the control

panel when deciding about the mounting height.

8. Optional: Attach the Cover plate to the Wall mount using the
5 M6x6 4 mm hexagon screws. And attach the pole clamp to the
Cover plate using the 4 M5 screws which were removed during
step 3 using a 4 mm hexagon key.

6 Operation
6.1 Safety instructions before operation
Warning!
When using the device, first read the warnings in Warnings on page 8.
The device is intended to be used only by trained clinicians. Intended patient population: adults
and pediatric patients.
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).
6.2 Connecting the Mistral-Air® QC Hose (MA1200-1018 &

MA1200-1018XL) to the device
1. Check the QC Hose or QC Hose XL for damage.

2. Hold on to the front-end hose connector (knee part).
3. Place the front-end of the hose into the quick connector.
4. Press the connector firmly into the blower until a "click" is produced.
5. Check to ensure the hose is firmly connected.
The QC Hose can be rotated 360° for optimal range.
6.3 Connecting the power supply
See Connecting the power supply cord on page 27 if the power supply cord is not yet
connected to the device.
User Manual - Operation 31 of 48

1. Plug the device into an earthed mains socket.
2. The device automatically switches to the standby mode, which is indicated by the orange
standby LED located on the left side of the control panel.
6.4 Connecting the blanket

1. Take the selected Mistral-Air® blanket out of the package and follow the instructions on the
insert provided with the blanket box.
2. Place the unit near the hose inlet of the blanket.
3. Insert the end of the flexible hose into the air inlet port of the Mistral-Air® blanket.
4. Check if the hose is fully pushed in.
6.5 Turning on the device
Caution!
Stay in viewpoint of the control panel when the device is performing the self-test and
selecting the set-point.
1. Activate the device by pressing the standby button. The LED turns green.
2. The device will now perform a self-test, which includes a flash of all the LED's and a short
beep. When a LED or the audible beep fails, take the device out of use for repair.
3. After the self-test, which lasts several seconds, the device will start blowing air at the default
temperature setting of 38°C.
6.6 Selecting the temperature

The description of the setpoints corresponds to the average temperature under the blanket. There
are four temperature setpoints:
• Fan only/ambient air: Ambient air temperature. The air temperature to the patient will depend on
ambient conditions and possible heat from the fan motor.
• 32°C: Low temperature.
• 38°C: Medium temperature.
• 43°C: High temperature.
The selected temperature is indicated by one of four green temperature selection indicator LED's,
see Overview of the control panel on page 18.
1. After the self-test, the device will start blowing air at the default temperature setting of 38°C.
2. Press the – button twice to deactivate the heater. The fan only/ambient air indicator turns
green and air at ambient temperature is blown to the patient.
3. Press the + button to activate the heater.
4. Press the + button multiple times to increase the air temperature at the blanket to a setpoint of
38°C, or 43°C.

5. Press the – button to decrease the temperature setpoint.
After selecting the desired temperature, the LED next to the temperature indicator symbol will flash
green. After reaching the set temperature (+/- 2°C), the green LED lights up continuously.
6.7 Stopping warming
1. Press the standby button.

2. Disconnect the hose from the blanket.
3. If desired, leave the blanket on/under the patient.
4. If desired, replace the QC Hose (only for MA1200-QC).
Caution!
To remove all power from the device, the mains power cord must be removed from the
electrical receptacle.

7 Maintenance
Warning!
• Maintenance may only be performed by trained biomedical technicians or engineers.
Both user groups must be trained by certified trainers from The 37Company.
• Preventive maintenance needs to be performed on an annual basis. Please refer to the
Mistral-Air® technical manual for maintenance, repair and calibration instructions. The
Mistral-Air® technical manual is available for download at the business partner menu of
the The 37Company website.
Caution!
Clinical users may not repair or open the device in the event of a malfunction. This can
damage the appliance and will invalidate the warranty.
Have the device serial number ready when you contact the hospital service department or the local
supplier for technical support. The serial number is located on the label on the back of the device.
Before performing maintenance, consult the device insulation diagram below.
User Manual - Maintenance 34 of 48

7.1 Cleaning
Warning!
• Before you clean the device, disconnect the power supply cord to eliminate the risk of
electrocution.
• Do not use dripping wet cloths.
• Do not use ketones (MEK, acetone, etc.) or abrasive cleaners.
• Do not use alcohol based cleaners (except isopropyl alcohol and ethanol).
• Do not use acid based cleaners.
• Do not use oxidizing cleaners.
• Do not exceed the concentration specified by the manufacturer; or use premixed
solutions.
• Do not use steam sterilization (autoclave) or dry heat to sterilize the device.
• Do not immerse the device in liquids. Otherwise, the device can be damaged.
• Make sure that fluids cannot enter the electrical areas of the device.
• Do not place the device upside down, or on its sides.
• Clean the hose at ambient temperature and make sure the hose is dry before use.
Damage to the hose or device may occur.
To clean the surface of the device:

1. Use a soft cloth lightly dampened with a solution of hand warm water with a mild detergent
solution or use one of the following disinfectants:
• isopropyl alcohol (isopropanol) based cleaners ≤ 90%
• ethyl alcohol (ethanol) based cleaners ≤ 90%
2. Use a moist cloth to remove excessive detergent or disinfectant.
3. Wipe the surface (including the hose).
4. Let the device air dry.
5. If desired, remove the QC Hose for cleaning or replacement before cleaning the device (only
for MA1200-QC).
7.2 Corrective maintenance
Warning!
Maintenance may only be performed by trained biomedical technicians or engineers. Both
user groups must be trained by certified trainers from The 37Company.
7.2.1 Replacing the Mistral-Air® Filter (MA1200-1001)

The accumulation of dust in the air filter will reduce the efficiency of the device. The filter must be
replaced when the Filter Replacement indicator is activated, or when indicated by visual inspection.
Only use parts provided by The 37Company or your local distributor.

Warning!
• Do not return the device from service without the filter present.
• Before performing a repair, disconnect the power supply cord to eliminate the risk of
electrocution. There are electrically live parts within the device when it is connected to a
power supply.
Caution!

3. Remove the two screws of the filter cap with a 4 mm hex key.
4. Remove the filter cap.
5. Remove the filter.
6. Place the replacement filter in the filter cap with the rubber
seal facing up.

7. Place back the filter cap.
8. Place back the screws and tighten them with a maximum

torque of 2.1 ± 0.2 Nm.
9. Connect the power plug to the wall socket and leave the
device in standby mode.
10. Press and hold the -, + and the alarm suppression buttons
simultaneously.
11. While holding down the three buttons, press the standby
button.
You will hear a beep and the device returns to standby

mode, indicating that the Filter timer has been reset.
12. Dispose the replaced filter according to hospital protocol.
7.2.2 Replacing the Mistral-Air® Hose (MA1100-1018 &

MA1100-1018XL)
Warning!
• When replacing the hose, do not touch the temperature

sensors. If these sensors are touched in any way, they
can be damaged and out of calibration. This could
cause burns to the patient. If the temperature sensors
are touched or damaged, perform the after-service
test protocol after replacing the hose (see Mistral-Air®
Warming Unit Technical Manual).
• Before performing corrective maintenance (see
Corrective maintenance on page 35), disconnect the
power supply cord to eliminate the risk of electrocution.
There are electrically live parts within the device when it
is connected to a power supply.
Changing the 1.8 m long hose for a 3 m long hose reduces the temperature of the air
transferred to the patient with at least 1.9 °C.

Caution!

3. Unscrew the screw that fixes the hose.
4. Unscrew the hose by rotating it clockwise.
5. Attach a new hose by rotating the hose anti-clockwise.
6. Pierce the hose with a sharp object at the location where the
screw must be attached. Apply and tighten the screw that fixes
the hose.
7. Dispose the replaced hose according to hospital protocol.

7.2.3 Replacing the Mistral-Air® QC Hose (MA1200-1018 &
MA1200-1018XL)
Warning!
Before performing corrective maintenance (see Corrective maintenance on page 35),
Caution!
Changing the 1.8 m long hose for a 3 m long hose reduces the temperature of the air
transferred to the patient with at least 1.9 °C.

2. Place the device upright.
3. Push down the quick release button.
4. Pull out the hose from the blower.
5. Attach a new hose by placing it in front of the quick connector.

6. Press the connector firmly into the blower, until a "click" is
produced.
7. Check to ensure the connector is fully depressed.

8. Dispose the replaced hose according to hospital protocol.
Warning!
To attach the hose with a quick connector, firmly press the hose connector until the
connector is fully depressed. Check to ensure the connector is securely locked on the
blower.
7.2.4 Replacing the power cord
Warning!
The 37Company of this equipment could result in increased electromagnetic emissions
or decreased electromagnetic immunity of this equipment and result in improper
operation.
• Before performing corrective maintenance (see Corrective maintenance on page 35),
Caution!

3. Remove the mains cover using a 4 mm hex key.

4. Unplug the C13 plug from the device.
5. Insert a new The 37Company power supply cord and press it
firmly into place.
6. Reattach the mains cover to lock the C13 plug by tightening
the 4 mm hex screw with a maximum torque of 1.5 ± 0.2 Nm.
7. Perform an IEC 60601-1 electrical safety test.
8. Dispose the replaced power cord according to hospital
protocol.

8 Troubleshooting
Problem Possible Cause Action
The device does not switch on. Unplugged or damaged power Make sure power cord is
cord plugged in and is undamaged.
Replace cord if necessary.
No power to outlet Confirm power to outlet.
Poor or loose wire connections Ensure all connectors and

terminals are secure.
Blown fuses at PCBA Send the device to a certified

service department for
technical support.
The technical alarm is activated Obstructed air flow path If this alarm occurs, check
and the warming device for anything blocking the air
Poor or loose wire connections,
stopped working. flow path (e.g. blocked inlet,
or damaged heater or
blocked hose end, or kink
electronics
in the hose). Remove the
Large mains power dip (≥ 30%) obstruction(s), unplug the
for more than 1/60 of a second device from mains power,
reconnect it and verify the
alarm is gone. Press standby
to activate the device again. In
case of a recurring alarm, send
the device to a certified service
department for technical
support.
The microcontroller watchdog Malfunctioning electronics Send the device to a certified

alarm is activated. service department for
technical support.
The device does not deliver Obstructed air flow path Check for anything blocking the
enough air. air flow path and remove the
obstacles.
Clogged air filter Send the device to the
technical department to replace
the filter with new filter supplied
by The 37Company.
Fan duty cycle set at low Send the device to the
technical department to set the
fan duty cycle to normal.
Other technical problems. Unidentified cause Send the device to a certified
service department for
technical support.
User Manual - Troubleshooting 42 of 48

9 Specifications
9.1 Specifications of the device

General specifications
Article number MA1200-EU MA1200-US
Rated voltage 220-240 V~ 100-125 V~
Frequency 50/60 Hz 50/60 Hz
Device sound pressure 48 dBA 51 dBA
Average current 3.2 A 6.1 A
Peak current 9.0 A 10.0 A
Peak power 1000 VA 1000 VA
Average power at 43°C and 750 VA / 600 W 800 VA / 610 W

tamb 22 +/- 1.5°C
Fuses 6.3AHF/250V~ 10AHF/250V~
Air flow rate at nominal Up to 101 [Nm³/h] or 59 [CFM] Up to 88 [Nm³/h] or 52 [CFM],

voltages and ambient (depending on orientation of (depending on orientation of
temperature (1.8 m hose) the hose, supply voltage, type the hose, supply voltage, type
and drape of the blanket) and drape of the blanket)
Air flow rate at nominal Up to 91 [Nm³/h] or 53 [CFM] Up to 79 [Nm³/h] or 47 [CFM],
voltages and ambient (depending on orientation of (depending on orientation of
temperature (1.8 m hose), low the hose, supply voltage, type the hose, supply voltage, type
fan duty cycle and drape of the blanket) and drape of the blanket)
GMDN code 36954 (circulating-air whole-body heating system control unit)
Dimensions 16 cm x 35 cm x 40 cm (l x w x h)
Weight 5.2 kg
Hose length 1.8 m (3 m hose optional)
Power supply cord length 4.0 m
Filtration HEPA H13 class filter, conform EN 1822-1:2009
Classification 93/42/EEC Class IIb
Classification IEC 60601-1 Class I, Body Floating (BF)
Overvoltage category Category II

according to IEC 60664-1
Classification IEC 60529 IP23
Setpoint temperature Ambient air, 32°C, 38°C, 43°C
User Manual - Specifications 43 of 48

Accuracy of temperature at the ± 2.5 °C (under all validated operating environmental conditions)
end of the hose
Setpoint reached after Under 30 seconds
Low temperature limit 10°C
Maximum average contact 45.5°C (Compliant with IEC 80601-2-35)

surface temperature
High temperature safety limit < 56°C (Compliant with IEC 80601-2-35)
Auditory alarm signal sound 80 dBA

pressure
Applicable technical standards IEC 60601-1:2005+A1:2012, IEC 80601-2-35:2016
Expected lifetime device 7 years
Expected lifetime hose 1 year
The essential performance of the Mistral-Air Warming System is: when supplying air to the patient
“the Maximum CONTACT SURFACE TEMPERATURE” must be below the safe temperature limits
according to IEC 80601-2-35: 2009 + C1:2012 +C2:2015, Clause 201.11.1.2.1.102.
Validated operating environmental specifications
Ambient temperature 15°C to 30°C
Relative humidity 30% to 75%
Validated transport and storage specifications
Ambient temperature -20°C to 70°C
Relative humidity 10% to 90% (non-condensing)
Atmospheric pressure 50 kPa to 106 kPa
User Manual - Specifications 44 of 48

10 Electromagnetic compatibility
Warning!
The 37Company of this device could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this device and result in improper operation.
• Use of this device adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this device and
the other equipment should be observed to verify that they are operating normally.
• Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm to any part of the
device, including cables specified by the manufacturer. Otherwise, degradation of the
performance of this device could result.
• The Emissions characteristics of this device make it suitable for use in industrial areas
and hospitals (CISPR 11 class A). If it is used in a residential environment (for which
CISPR 11 class B is normally required) this device might not offer adequate protection
to radio-frequency communication services. The user might need to take mitigation
measures, such as relocating or reorienting the device.
• It is possible that a technical alarm is triggered at a 30% dip. Degradation does not
affect ESSENTIAL PERFORMANCE and BASIC SAFETY and is therefore compliant.
Refer to Troubleshooting on page 42 and Specifications of the device on page 43 for a
solution.
• This device complies with IEC 60601-1-2:2014 for electromagnetic compatibility.
However, if electromagnetic interference with nearby devices is experienced, the user is
encouraged to take one or more of the following measures:
• Isolate the offending device.
• Reorient or relocate this device.
• Increase the distance between the interfering device and this device.
• Use another mains socket.
If electromagnetic incompatibility is still experienced, please contact your distributor.
10.1 Electromagnetic immunity

Guidance and manufacturer’s declaration - electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer
or the user of the device should assure that it is used in such an environment.
Immunity test IEC60601 test level
Electromagnetic discharge (ESD) ± 8 kV contact

EN-IEC 61000-4-2 (2009)
± 15 kV air
User Manual - Electromagnetic compatibility 45 of 48

Immunity test IEC60601 test level
Electrical fast transient (EFT) / burst ± 2 kV

EN-IEC 61000-4-4 (2012)
Surge ± 1 kV L-N
EN-IEC61000-4-5 (2014)
± 2 kV L-PE / N-PE
Voltage dips, short interruptions and voltage variations on power 0% UT for 0.5 cycle
supply input lines
0% UT for 1 cycle
EN-IEC 61000-4-11 (2004)
70% UT for 25/30 cycles
0% UT for 250/300 sec
Power frequency (50/60 Hz) magnetic field IEC 30 A/m

EN-IEC 61000-4-8 (2010)
Conducted RF 3 Vrms + 6 Vrms (ISM +

EN-IEC 61000-4-6 (2014) Amateur)
Radiated RF 3 V/m
EN-IEC 61000-4-3 (2006) + A1 (2008) + A2 (2010)
Proximity fields from RF wireless communications equipment 9-28 V/m

EN-IEC 61000-4-3 (2006) + A1 (2008) + A2 (2010)
Electrical transient conduction along supply lines Not applicable (system not
ISO 7637-2 (2004) intended for use in vehicles)
10.2 Electromagnetic emissions

Guidance and manufacturer’s declaration – electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below. The customer
or the user of the device should assure that it is used in such an environment.

Emissions test Compliance
RF emissions Group 1
CISPR 11 (2015)
RF emissions Class A
CISPR 11 (2015)
Harmonic emissions Not applicable (the device is suitable for use

IEC 61000-3-2 (2018) in all establishments other than domestic and
those directly connected to the public low-
Voltage fluctuations/flicker emissions voltage power supply network that supplies
IEC 61000-3-3 (2017) buildings used for domestic purposes)
10.3 Recommended separation distances

Recommended separation distances between portable and mobile RF communications
equipment and the device
The device is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the device can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the device as recommended below, according to the
maximum output power of the communications equipment.
Separation distance according to frequency of transmitter (m)
Rated maximum 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
output power of
transmitter (W)
0.01 0.12 0.12 0.24
0.1 0.37 0.37 0.74
1 1.17 1.17 2.34
10 3.69 3.69 7.38
100 11.67 11.67 23.34
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.

The 37Company
Beeldschermweg 6F
NL-3821 AH Amersfoort
+31 (0)33 450 72 50
Solutions for Patient Warming
www.the37company.com
[email protected]

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User Manual

Forced Air Warming Unit

2 Contraindications, warnings, cautions, notes and symbols................................................... 8

4 Accessories and disposables...................................................................................................22

User Manual - Contents 3 of 48

User Manual - Contents 4 of 48

1.1 About this manual

1.2 Indications for use

Tel: +31 (0)33 450 72 50

Refer to the website for local distributors.

1.4 FAQ and training

User Manual - General information 5 of 48

1.6 Authorisation of personnel

1.7 Warning, caution and note

A "note" provides more information.

1.8 Disclaimer and intellectual property statement

User Manual - General information 6 of 48

User Manual - General information 7 of 48

User Manual - Contraindications, warnings, cautions, notes and

User Manual - Contraindications, warnings, cautions, notes and

User Manual - Contraindications, warnings, cautions, notes and

2.5 Device safety symbols

Caution: Federal US law restricts this device to sale by or on order of a physician.

Check patient’s temperature and skin condition at least every 15 minutes, or

User Manual - Contraindications, warnings, cautions, notes and

Transport and storage ambient temperature limits

Transport and storage relative humidity limits

Transport and storage atmospheric pressure limits

Type BF applied parts (according to IEC 60601-1:2005+A1:2012)

Read the user manual.

Consult the instructions for use.

User Manual - Contraindications, warnings, cautions, notes and

Dispose according to European Community Directive 2002/96/EC (WEEE).

Caution. Consult the instructions for use for important cautionary.

Low priority alarm indication on control equipment

Medium priority alarm indication on control equipment

Temporarily audible alarm suppression

Upper limit of temperature, overtemperature alarm

Air flow at ambient temperature (not heated)

32°C Air flow setpoint at a temperature of 32°C (heated)

User Manual - Contraindications, warnings, cautions, notes and

43°C Air flow setpoint at a temperature of 43°C (heated)

Maintenance may be only performed by trained biomedical technicians or

Before using the device, it should be attached to a pole, Mistral-Air® Adjustable

2.6 Blanket safety symbols

Not for use in magnetic resonance imaging (MRI)

Caution: Federal US law restricts this device to sale by or on order of a physician.

Do not use the device if the package is damaged.

Catalogue / article number

User Manual - Contraindications, warnings, cautions, notes and

Batch code / lot number

S = Small, M = Medium, L = Large, XL = Extra large

Check patient’s temperature and skin condition at least every 15 minutes, or

Transport and storage ambient temperature range

Transport and storage relative humidity range

Transport and storage atmospheric pressure limitation

Expiry date, year/month

User Manual - Contraindications, warnings, cautions, notes and