3M Bair Hugger 775 User manual

Model 775
Warming Unit
Operator’s Manual
Normothermia System
-Unidade de Aquecimento
3M™ Bair Hugger™, Modelo 775
Manual do Usuário
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I3M™ Bair Hugger™ 775 型加温器
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13M™ Bair Hugger™
Warming Unit Model 775
Operator’s Manual
2areil de réchauffement
Bair Hugger™ 3M™, modèle 775
Manuel de l’utilisateur
33M™ Bair Hugger™-Wärmeeinheit,
Modell 775
Bedienungsanleitung
4Unità riscaldante
3M™ Bair Hugger™ modello 775
Manuale d’uso
5Unidad de calentamiento
modelo 775 Bair Hugger™ de 3M™
Manual del operador
63M™ Bair Hugger™-verwarmingsunit
model 775
Bedieningshandleiding
73M™ Bair Hugger™ värmeenhet,
modell 77521
Användarhandbok
83M™ Bair Hugger™ varmeenhed,
model 775
Betjeningsvejledning
93M™ Bair Hugger™ Varmeenhet,
modell 775
Brukerhåndbok
03M™ Bair Hugger™
-lämpöpuhallinmalli 775
Käyttöopas
3M™ Bair Hugger™   775 
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Model 775
Warming Unit
Operator’s Manual
Normothermia System
Description:
Base File Name:
Software:
SGS Contact:
Email:
Printer:
Printer Location:
Supplier:
3M
TM
Bair Hugger™
Patient Adjustable Warming Unit
Requester: Frank Boeshart/Debra Staack
Reference:
Die # / Doc. Size: 8.5" x 11"
Item Spec#:34-8718-8811-0
Supersedes#:
Cat/Product#:Model 775
Structure#:
Manual
PA: 34871888110.indb
GA:
InDesign CC 2014 - BOOK
PROCESS
BLACK
PMS
280
4394547 5
08.02.16 New Build kmh
08.04.16 Updated Final pages number. Jer
08.25.16 Alts per PDF file kmh
08.30.16 Final release. DJ
09.24.16 Adjust Center Margins to 1 in. to accomodate spiral binding and Final Release kmh

1
GB / 34-8718-8811-0
1Table of Contents
Introduction................................................................................................................................................................................... 3
Description Of The 3M™ Bair Hugger™ Temperature Management System ......................................................... 3
Indications.............................................................................................................................................................................. 3
Denition Of Symbols ......................................................................................................................................................... 3
Contraindications, Warnings, Cautions And Notices ........................................................................................................... 3
Explanation Of Signal Word Consequences................................................................................................................... 3
CONTRAINDICATION: ...................................................................................................................................................... 4
WARNING: ............................................................................................................................................................................ 4
CAUTION: ............................................................................................................................................................................. 4
Notices ................................................................................................................................................................................... 5
Proper Use And Maintenance............................................................................................................................................ 5
Read Before Servicing Equipment .................................................................................................................................... 5
Overview And Operation............................................................................................................................................................ 5
Warming Unit Power-On-Reset......................................................................................................................................... 6
Overview Of Control Panel................................................................................................................................................ 6
Mounting The Warming Unit To An IV Pole .....................................................................................................................7
Instructions For Use......................................................................................................................................................................7
Viewing The Temperature Mode Timer............................................................................................................................7
What To Do In Case Of An Over-Temperature Condition ............................................................................................7
What To Do If A Fault Condition Occurs..........................................................................................................................7
General Maintenance And Storage .......................................................................................................................................... 8
Cleaning Instructions........................................................................................................................................................... 8
Storage ................................................................................................................................................................................... 8
Technical Service And Order Placement ................................................................................................................................ 8
When You Call For Technical Support ............................................................................................................................. 8
In-Warranty Repair And Exchange ................................................................................................................................... 8
Specications........................................................................................................................................................................ 8

3
GB / 34-8718-8811-0
13M™ BairHugger™ Warming Unit Model775
Operator’sManual
Introduction
Description of the 3M™ BairHugger™ Temperature
ManagementSystem
The BairHugger temperature management system consists of a
Model 775warming unit (with optional rolling stand, and other
accessories) along with a 3Mwarming blanket, BairHugger warming
gown, or the 3M™ Ranger™ 241blood/fluid warmingset.
The BairHugger warming unit is attached to the warming blanket or
warming gown by means of a flexible hose. Warm air is generated
in the warming unit and flows through the warming unit hose and
into the blanket or gown. Depending on the model, the 3Mblanket
or gown is placed either around, over, or underneath the patient.
Small perforations on the blanket or gown allow the warm air to be
dispersed over the patient. For blood/fluid warming applications, the
Model 241blood/fluid warming set is inserted in the warming unit
hose. When the warming unit is turned ON and a temperature setting
is selected, warm air flows over the Model 241tubing and warmed
blood/fluid exits from the distal end of the tubing. For additional
information on 3Mblankets, gowns, the 241warming set, or other
accessories visit us online atbairhugger.com.
This manual includes operating instructions and warming unit
specifications for the Model 775warming unit. You can use the
Model 775warming unit in all clinical settings where the patient may
feel too warm or too cold; including the operating room to provide
patient temperature management. For information about using
3Mblankets, gowns or the 241blood/fluid warming set with the
Model 775warming unit, refer to the respective Instructions forUse.
Indications
The BairHugger temperature management system is intended
to prevent and treat hypothermia. In addition, the temperature
management system can be used to provide patient thermal comfort
when conditions exist that may cause patients to feel too warm or too
cold. The temperature management system can be used with adult
and pediatricpatients.
• The BairHugger temperature management system should
only be used by trained medicalprofessionals.
• Federal law (USA) restricts this device to sale by or on the
order of a licensed healthcareprofessional.
Definition ofSymbols
The following symbols may appear on the product’s labeling or
exteriorpackaging.
An equipotentiality plug (grounded) conductor
other than a protective earth conductor or a
neutral conductor, providing a direct connection
between electrical equipment and the potential
equalization busbar of the electrical installation.
Please consult IEC 60601-1 forrequirements.
Fuse
Type BF equipment (patientapplied)
Date ofmanufacture
Manufacturer
Voltage, alternating current(AC)
This system is subject to European WEEE
Directive2002/96/EC. This product contains
electrical and electronic components and
must not be disposed of using standard refuse
collection. Please consult local directives for
disposal of electrical and electronicequipment.
Protective earthground
No freehosing
High fansetting
Low fansetting
Non-explosionproof
Consult instructions foruse
Follow instructions foruse
Recycle to avoid environmental contamination.
This product contains recyclable parts. For
information on recycling, please contact your
nearest 3MService Center foradvice.
Attention; see instructions foruse
Keepdry
Temperaturelimit
Contraindications, Warnings, Cautions andNotices
Explanation of Signal WordConsequences
!
WARNING: Indicates a hazardous situation which, if not
avoided, could result in death or seriousinjury.
!
CAUTION: Indicates a hazardous situation which, if not
avoided, could result in minor or moderateinjury.
NOTICE: Indicates a situation which, if not avoided, could result in
property damageonly.

43M™Bair Hugger™ Model 775 Warming Unit – Operator’s Manual
!
CONTRAINDICATION: To reduce the risk of thermalinjury:
• Do not apply heat to lower extremities during aortic
cross-clamping. Thermal injury may occur if heat is applied
to ischemiclimbs.
!
WARNING: To reduce the risk of thermalinjury:
• The BairHugger Model 775warming unit has been
designed to operate safely ONLY with 3Mdisposable
warming products. Use with other products may cause
thermal injury. To the full extent permitted by law, the
manufacturer and/or importer declines all responsibility for
thermal injury resulting from the warming unit being used in
conjunction with non-3Mproducts.
• Do not treat patients with the warming unit hose
alone. Always attach the hose to a 3Mwarming
blanket/gown before providing warmingtherapy.
• Do not allow the patient to lie on the warming unithose.
• Do not allow the warming hose to directly contact the
patient’s skin during warmingtherapy.
• Do not leave neonates, infants, children and other
vulnerable patient populations unattended during
warmingtherapy.
• Do not leave patients with poor perfusion unmonitored
during prolonged warmingtherapy.
• Do not place the non-perforated side of the warming
blanket/gown on the patient. Always place the perforated
side (with the small holes) directly on top of the patient in
contact with the patient’sskin.
• Do not connect a torn or damaged warming blanket/gown
to the warmingunit.
• For over-body warming blankets and gowns; do not place
patient securement device (i.e. safety strap or tape) over
the warmingblanket/gown.
• For underbody or side channel warming blankets; if a
securement device (i.e. safety strap, tape) is used, ensure
the warming channels are notoccluded.
• Do not place the warming blanket/gown directly over a
dispersive electrodepad.
• Do not continue warming therapy if the red Over-temp
indicator light illuminates and the alarm sounds. Unplug the
warming unit and contact a qualified servicetechnician.
• Do not continue 241blood/fluid warming therapy if the
red Over-temp indicator light illuminates and the alarm
sounds. Immediately stop fluid flow, and discard the blood/
fluid warming set. Unplug the warming unit, and contact a
qualified servicetechnician.
• For the BairHugger flex warming gown; ensure that the
blood pressure cuff, ECG, IV or other lines or cords are
not between the upper sleeve insert and the gown prior to
deploying the upper sleeve warming insert(s), as this could
result in tearing of the insert duringdeployment.
• Do not perform the over-temperature detection system test
while the warming unit is being used for warmingtherapy.
!
WARNING: To reduce the risk of patient injury or death due to
altered drugdelivery:
• Do not use a warming blanket/gown over transdermal
medicationpatches.
!
WARNING: To reduce the risk of injury due to interference
withventilation:
Do not allow the warming blanket/gown or head drape to
cover the patient’s head or airway when the patient is not
mechanicallyventilated.
!
WARNING: To reduce the risk of injury due to patientfalls:
• Do not use a warming blanket/gown to transfer or move
thepatient.
!
WARNING: To reduce the risks associated with hazardous
voltage andfire:
• Keep power cord visible and accessible at all times. The
plug on the power cord serves as the disconnectdevice.
• Only connect to outlets marked “Hospital only,” “Hospital
Grade,” or a reliable groundedoutlet.
• Use only the power cord specified for this product and
certified for the country ofuse.
• Do not allow the power cord to getwet.
• Do not use the warming unit when it appears the warming
unit, power cord or any component is damaged. Replace
the warming unit. Contact 3MTechnicalSupport.
• Do not disassemble the warming unit unless you are a
qualified service technician. There are electrically live
parts within the warming unit when it is connected to a
powersource.
• Connect each warming unit being tested to a separate
powersource.
!
CAUTION: To reduce the risk ofcross-contamination:
• Except for specific BairHugger warming blanket models,
3Mwarming blankets/gowns are not sterile. Each warming
blanket/gown is intended for single patient use ONLY.
Placing a sheet between the warming blanket/gown and
the patient does not prevent contamination of theproduct.
• Clean the warming unit and the outside of the warming unit
hose after each patient use. See “Cleaning Instructions” on
page8.
• Follow applicable regulations when disposing of this
warming unit or any of its electricalcomponents.
• Do not attempt to clean the air filter as it may be
contaminated from use. Discard the filter in a manner
consistent with institutionalprotocol.
• Do not operate the BairHugger warming unit with the
hose detached from the 3Mwarming blanket/gown. The
BairHugger warming unit is intended to be used with
the hose properly attached to its corresponding warming
blanket/gown and in accordance with good practices for
operating room steriletechnique.
!
CAUTION: To reduce the risk of patient or caregiverinjury:
• If mounted on an IV pole, the distance from the bottom of
the warming unit to the floor must be less than 44” (112cm)
and the IV pole wheelbase diameter must be at least 28”
(71cm) to preventtipping.
!
CAUTION: To reduce the risk offire:
• 3Mwarming blankets and gowns are classified as Class I
Normal Flammability as defined by the Consumer Product
Safety Commissions flammable fabric regulation, 16CFR
1610. Follow standard safety protocols when using high
intensity heatsources.
!
CAUTION: To reduce the risk of thermal injury, hyperthermia
orhypothermia:
• 3Mrecommends continuously monitoring core
temperature. In the absence of continuous monitoring,
monitor the temperature of patients who are incapable
of reacting, communicating and/or who cannot sense
temperature a minimum of every 15minutes or according to
institutionalprotocol.

5
GB / 34-8718-8811-0
• Monitor cutaneous responses of patients who are incapable
of reacting, communicating and/or who cannot sense
temperature a minimum of every 15minutes or according to
institutionalprotocol.
• Adjust air temperature or discontinue therapy when the
therapeutic goal is reached, if elevated temperatures are
recorded or if there is an adverse cutaneous response in the
warmedarea.
• Do not place the warming unit on a soft uneven surface,
such as a bed, or a visibly wet surface as the air intake may
become blocked and cause the warming unit to overheat,
compromising the warming unit’sperformance.
• Perform all temperature testing of the warming unit with a
3MModel 22110temperature testunit.
!
CAUTION: To reduce the risk associated with
electromagnetic interference (EMI) due to portable and
mobile radio frequency (RF) communicationsequipment:
• The 3MBairHugger temperature management system has
been tested to be resistant to both EMI and electrostatic
discharge(ESD).
• Install and put into service the 3MBairHugger temperature
management system according to the electromagnetic
compatibility (EMC) information provided in the Guidance
and Manufacturer’sDeclaration.
• Should interference occur, move away from the portable or
mobile RF communicationsequipment.
Notices
1. The BairHugger warming unit meets medical electronic
interference requirements. If radio frequency interference with
other equipment should occur, connect the warming unit to a
different powersource.
2. To avoid warming unitdamage:
• Use proper Electrostatic Discharge (ESD) procedures when
performingmaintenance.
• Do not modify this equipment without authorization from
themanufacturer.
• Do not immerse the warming unit, warming unit parts
or accessories in any liquid or subject them to any
sterilizationprocess.
• Do not use cleaning solutions with greater than 80%
alcohol or solvents, including acetone and thinner, to clean
the warming unit or hose. Solvents may damage the labels
and other plastic parts.
Proper Use andMaintenance
3Massumes no responsibility for the reliability, performance, or
safety of the warming unit if the following eventsoccur:
• Modifications or repairs are performed by
unqualifiedpersonnel.
• The warming unit is used in a manner other than that
described in the Operator’s or ServiceManual.
• The warming unit is installed in an environment
that does not meet the appropriate electrical and
groundingrequirements.
• The warming unit not maintained in accordance with the
procedures described in the ServiceManual.
Read Before ServicingEquipment
All repair, calibration and servicing of the warming unit require the
skill of a qualified, medical equipment service technician who is
familiar with good practice for medical device repair. If service does
not require the manufacturer’s attention, the Model 775Service
Manual provides the technical information needed to service the
warming unit. Perform all repairs and maintenance in accordance
with the instructions in the Service Manual. For additional service
information please contact 3Mtechnicalsupport.
Overview andOperation
Figure B. Model 775Warming Unit – rearview
IV pole clamp
Hose
Hose connection
Power cord
connection
Figure A. Model 775Warming Unit – frontview
Alphanumeric
display
Control Panel
Carrying
handle
Warming UnitPower-On-Reset
The Model 775warming unit automatically performs the following
power-on-reset sequence after you connect the warming unit to a
properly grounded powersource:
• Performs all self-testfunctions.
• Illuminates indicator lights and all pixels in the
alphanumeric displaymomentarily.
• Displays the text “MD 700’s” and the software revision
level in the alphanumericdisplay.
• Sounds the alarm (three low-levelclicks).
• Enters the Standby mode with the high fan setting selected
bydefault.
Note: The low fan setting indicator light will not illuminate
during powerup.
If the warming unit loses power for less than 1second, the warming
unit software will return the warming unit to the operating mode
you selected prior to the power loss. However, if the warming unit
loses power for longer than 1second, the warming unit software will
reset when you restore power. The warming unit will then enter the
Standby mode with the high fan setting selected bydefault.

63M™Bair Hugger™ Model 775 Warming Unit – Operator’s Manual
Overview of ControlPanel
TEMP IN RANGE
FAULT
OVER TEMP
STANDBY
AMBIENT
MODEL 775 43 C
MEDIUM
HIGH
TEMPERATURE
AIR FLOW
38 C
LOW
32 C
System
High Fan
Setting
Alphanumeric Display Temperature
Modes
Low Fan
Setting
Figure C. Model 775 Warming Unit Control Panel
ALPHANUMERICDISPLAY
The alphanumeric display shows the temperature at the end of the
BairHugger warming unit hose in degreesCelsius.
TEMPERATUREMODES
• Press the 32˚C (Low), 38˚C (Med), or 43˚C (High) button to
select the desiredtemperature.
• Press the Ambient button to supply room temperatureair.
When you select a temperature mode, the following eventsoccur:
• Corresponding temperature indicator and fan setting
lightsilluminate.
• Blower operates at selected fanspeed.
• Temperature at the end of the hose appears in the
alphanumericdisplay.
• Heater activates except in ambientmode.
• Temperature mode timer and hour meteractivate.
• Temp in range indicator light illuminates when the
temperature at the blanket end of the hose is within +/-
1.5°C of the selected setting; this indicator light does not
illuminate in the ambientmode.
AIRFLOWMODES
The Model 775warming unit has two preset fan speed settings: a
default or high fan setting ( ) and a reduced or low fan setting ( ).
The Model 775warming unit will reset/default to the high fan setting
each time the warming unit is powered up or Standby is selected.
The low fan setting ( ) may be pre-selected while in Standby prior to
selecting the desiredtemperature.
STANDBY
Upon power up, the warming unit defaults to Standby and the high
fan setting. When the warming unit is in 32˚C (Low), 38˚C (Med), or
43˚C (High) or Ambient mode, press the Standby button to place the
warming unit in Standby mode. When you select the Standby mode,
the following eventsoccur:
•Standby indicator lightilluminates.
• Blower and heater are turnedOFF.
• Alphanumeric displaydeactivates.
• Alarm and fault detection functions remainactive.
• Operating timerpauses.
• Airflow mode resets/defaults to the high fansetting.
TEMP IN RANGE INDICATORLIGHT
The Temp in Range indicator light illuminates when the temperature at
the blanket or gown end of the hose is ±1.5°C of the selected setting;
this indicator light does not illuminate in the ambientmode.
FAULT INDICATORLIGHT
When a system fault occurs, the amber Fault indicator light flashes
and an audible alarm sounds. Please refer to What to Do in Case of a
Fault Condition on page 7for additionalinformation.
UNDER-TEMPFAULT
If the warming unit senses an under-temperature condition, the
amber Fault indicator light flashes and an audible alarm sounds.
Please refer to What to Do in Case of a Fault Condition on page 7for
additionalinformation.
OVER-TEMP INDICATORLIGHT
If the warming unit senses an over-temperature condition, the red
Over-temp indicator light flashes and an alarm sounds. Please refer to
What to Do in Case of an Over-Temperature Condition on page 7 for
additionalinformation.
Mounting the Warming Unit to an IVPole
To prevent tipping, clamp the Model 775warming unit to an IV pole
at a height that provides stability. Clamp the warming unit no higher
than 44” (112cm) from the floor on an IV pole with a minimum 28”
(71cm) diameterwheelbase.
!
Caution: If mounted on an IV pole, the distance from the
bottom of the warming unit to the floor must be less than 44”
(112cm) and the IV pole wheelbase diameter must be at least
28” (71cm) to preventtipping.
METHOD
To mount the Model 775warming unit to an IV pole, simply
turn the clamp handle clockwise to tighten the clamp on
the IV pole and counterclockwise to release it. Ensure
the IV pole bumper rests against the pole. See FigureD.
28 in.
(71 cm) minimum
44 in. (112 cm)
maximum
Figure D. Model 775 warming unit on an IV Pole
IV Pole
Bumper
Clamp
Handle

7
GB / 34-8718-8811-0
INSTRUCTIONS FORUSE
The instructions below describe how to operate the Model
775warming unit. For information about using 3Mblankets, gowns,
or the 241blood/fluid warming set with the Model 775warming unit,
refer to the respective Instructions forUse.
1. If the Model 775warming unit is not mounted on an IV pole or
BairHugger rolling stand, place the warming unit on a flat, hard,
dry surface, such as a table, before beginning warmingtherapy.
!
Caution: Do not place the warming unit on a soft uneven
surface, such as a bed, or a visibly wet surface as the air
intake may become blocked and cause the warming unit to
overheat, compromising the warming unit’sperformance.
2. Insert the end of the BairHugger warming unit hose in the
warming blanket or gown hose port. Use a twisting motion to
ensure a snug fit. A visual marker is located around the
mid-section of the hose end to guide the depth of hose
insertion. (Figures E). Support the hose to ensure
secureattachment.
!
Warning: Do not treat patients with the BairHugger
warming unit hose alone. Always attach the hose to a
BairHugger warming blanket/gown before providing
warmingtherapy.
Insert
marker
Figure E.
Hose port
Hose
3. Connect the warming unit to a properly grounded power
source. The warming unit will be in Standby mode and
the Standby indicator light will illuminate. The high fan
setting ( ) will be pre-selected by default with its indicator
light illuminated. The low fan setting ( ) may be pre-selected
prior to selecting the desired temperaturemode.
4. Press the appropriate button (i.e., 32˚C, 38˚C, 43˚C, or
Ambient) to select the desired temperature. This will turn
the blower and heater ON. When the warming unit reaches
the selected temperature, the Temp in Range indicator light
will illuminate; this indicator light does not illuminate in the
Ambientmode.
!
Caution: Patient MonitoringRecommendations:
• 3Mrecommends continuously monitoring core
temperature. In the absence of continuous monitoring,
monitor the temperature of patients who are incapable
of reacting, communicating and/or who cannot sense
temperature a minimum of every 15minutes or according to
institutionalprotocol.
• Monitor cutaneous responses of patients who are incapable
of reacting, communicating and/or who cannot sense
temperature a minimum of every 15minutes or according to
institutionalprotocol.
• Adjust air temperature or discontinue therapy when the
therapeutic goal is reached, if elevated temperatures are
recorded or if there is an adverse cutaneous response in the
warmedarea.
5. Press the Standby button when warming therapy is complete.
Disconnect the warming unit hose from the warming blanket/
gown and discard the blanket/gown per hospitalpolicy.
6. Unplug the warming unit to disconnect it from the
powersource.
Note: At any time, the fan speed setting can be switched between
high fan setting ( ) and low fan setting ( ) by pressing the
corresponding button. However, these buttons will not place the
warming unit into Standby.
Viewing the Temperature ModeTimer
The temperature mode timer records the amount of time the warming
unit has been operating in the selected temperature mode. The timer
resets itself every time you select a different temperature mode.
To view the temperature mode timer, press the button and hold for
3seconds for the current temperature mode. The alphanumeric
display will show the temperature mode time, then go back to
showing the temperature modesetting.
What to Do in Case of an Over-TemperatureCondition
If an over-temperature condition occurs, the red Over-temp indicator
light flashes and an audible alarm sounds and the warming unit
automatically turns OFF the heater, blower, and operating mode
indicator lights. A fault code appears in the alphanumericdisplay.
Note: Pressing any button will silence thealarm.
IF AN OVER-TEMPERATURE CONDITIONOCCURS:
!
Warning: Do not continue warming therapy if the red
Over-temp indicator light illuminates and the alarm
sounds. Unplug the warming unit and contact a qualified
servicetechnician.
!
Warning: Do not continue 241blood/fluid warming therapy
if the red Over-temp indicator light illuminates and the alarm
sounds. Immediately stop fluid flow, and discard the blood/fluid
warming set. Unplug the warming unit, and contact a qualified
servicetechnician.
1. Discontinue all warming therapy. If you are using the 241blood/
fluid warming set, immediately stop fluid flow and discard the
blood/fluid warmingset.
2. Press any button on the control panel to silence thealarm.
3. Unplug the warmingunit.
4. Replace warming unit. Do not attempt to restart or reset the
warmingunit.
5. Contact a qualified servicetechnician.
What to Do If a Fault Conditionoccurs
The Model 775warming unit software recognizes several
non-hazardous conditions and reports those conditions as faults.
When a system fault occurs, the software stores the fault code
in memory, the amber Fault indicator light flashes, and an alarm
sounds. The warming unit automatically turns the heater, blower,
and operating mode indicator lights OFF. The control panel will not
respond tocommands.
Note: Pressing any button will silence thealarm.
IF A FAULT CONDITIONOCCURS:
1. Unplug the warming unit and wait for 30-60seconds.
2. Reconnect the warming unit to a grounded power source. The
warming unit will perform the normal power-on-reset sequence
and then enter the Standbymode.
3. Reselect the temperaturesetting.
4. If the warming unit does not return to normal operation, contact
a qualified servicetechnician.

83M™Bair Hugger™ Model 775 Warming Unit – Operator’s Manual
General Maintenance andStorage
CleaningInstructions
1. Disconnect the warming unit from the power source
beforecleaning.
2. Cleaning should be performed in accordance with hospital
practices for cleaning OR equipment. After every use; wipe
the warming unit, the outside of the warming unit hose, and
any other surfaces that may have been touched. Use a damp,
soft cloth and a hospital approved mild detergent, germicidal
disposable wipes, disinfecting towelettes, or antimicrobial
spray.
3. Let air dry or dry with a separate clean softcloth.
Notice:
• Do not use cleaning solutions with greater than 80%
alcohol or solvents, including acetone and thinner, to clean
the warming unit or hose. Solvents may damage the labels
and other plasticparts.
• Do not immerse the BairHugger warming unit, warming
unit parts, or accessories in any liquid or subject them to
any sterilization process.
STORAGE
Store all components in a cool, dry place when not inuse.
Technical Service and OrderPlacement
USA
[phone]
OUTSIDEUSA
Contact your local service provider ordistributor.
When You Call for TechnicalSupport
We will need to know the serial number of your BairHugger
warming unit. The serial number label is located on the back of the
warmingunit.
In-Warranty Repair andExchange
USA
Call 3Mcustomer service if your Model 775warming unit requires
factory service. A customer service representative will give you a
Return Authorization (RA) number. Please use this RA number on
all correspondence concerning your warming unit. Your customer
service representative will also send a shipping carton to you at no
charge, if needed. Call your local supplier or sales representative
to inquire about borrowing a warming unit while we service your
warming unit. For more detailed instructions on returning warming
units for service, please refer to the Model 775ServiceManual.
OUTSIDE OF THEUSA
Contact your local distributor concerning in-warranty repair
andexchange.
Specifications
PhysicalCharacteristics
DIMENSIONS
13"high x 13"deep x 14"wide (33cm high x 33cm deep x
36cmwide)
WEIGHT
16lb(7.3kg)
RELATIVE NOISELEVEL
53dBA (High fansetting)
48dBA (Low fansetting)
HOSE
Flexible, compatible with the Ranger 241blood/fluid warmingset.
Length: 80"(203cm)
UNIT INTAKEFILTER
MERV14*
* See Frequently Asked Questions on Filtration (p.243)
RECOMMENDED FILTERCHANGE
Every 12months or 500hours ofuse.
MOUNTING
Can be clamped to an IV pole, placed on a hard surface, or mounted
to the rolling standaccessory.
TemperatureCharacteristics
RECOMMENDED OPERATING
ENVIRONMENTTEMPERATURE
15°C-25°C
HUMIDITY
Max relative humidity 80% (up to 31°C) decreasing linearly to 50%
relative humidity at40°C.
ALTITUDE
Max2,000m
TEMPERATURECONTROL
Electronicallycontrolled
HEATGENERATED
High fan setting: 1600BTU/hr (average), 470W(average)
Low fan setting: 1330BTU/hr (average), 390W(average)
OPERATINGTEMPERATURES
Average temperatures at the end of thehose:
HIGH:43° ± 1.5°C (109.4° ±2.7°F)
MED:38° ± 1.5°C (100.4° ±2.7°F)
LOW:32° ± 1.5°C (89.6° ±2.7°F)
TIME TO REACH OPERATINGTEMPERATURE
2 - 5minutes (dependent on blanketmodel)
Time required for the contact surface temperature to heat up from
23± 2°C to 37°C (73± 2°F to99°F).
STORAGE/TRANSPORTTEMPERATURE
-20°C to 45°C (-4°F to113°F)
Store all components in a cool, dry place when not inuse.

9
GB / 34-8718-8811-0
SafetySystem
THERMOSTAT
Independent electronic circuit; thermal cutoff shuts the heater OFF
to ensure hose end air remains below 56°C (53°C ± 3°C typical);
back-up over-temperature detection at warming unit hoseinlet.
ALARMSYSTEM
Over-temperature (≤56°C, 53°C ± 3°C typical): red Over-Temp
indicator light flashes, alarm sounds, heater and blower shut
down, operating indicator lights turn OFF, and control panel
becomesunresponsive.
FAULT
Amber Fault indicator light flashes, alarmsounds.
OVERCURRENTPROTECTION
Dual input fusedlines.
ElectricalCharacteristics
HEATINGELEMENT
1400WResistive
LEAKAGECURRENT
Meets UL 60601-1and IEC 60601-1requirements.
BLOWERMOTOR
Operating speed: 4,700rpm (high fansetting)
4,100rpm (low fansetting)
Airflow: up to 48cfm or 23L/s
POWERCONSUMPTION
Peak: 1550W
Average: 800W
POWERCORD
15ft., SJT, 3cond., 13A
15ft., SJT, 3cond., 15A
4.6m, HAR, 3cond., 10A
DEVICERATINGS
110-120VAC, 50/60Hz, 11.7A,or
220-240VAC, 50/60Hz, 7.2A,or
100VAC, 50/60Hz, 15A
FUSES
TYPE
Fast acting ceramic fuses, 250VAC
AMPRATING
12A (110 - 120VAC)
8A (220 - 240VAC)
15A (100VAC)
OPERATINGSPEED
F (FastActing)
BREAKINGCAPACITY
15A, 12A: 750A @ 250Vac
15A, 12A: 10,000A @ 125Vac
8A: 200A @ 250Vac
8A: 10,000A @ 125Vac
CERTIFICATIONS
IEC 60601-1; IEC/EN 60601-1-2; UL 60601-1; CAN/CSA-C22.2,
No.601.1; EN 55011; EN80601-2-35

10 3M™Bair Hugger™ Model 775 Warming Unit – Operator’s Manual
CLASSIFICATION
Guidance and manufacturer’s declaration – electromagneticemissions
The Model 775warming unit is intended for use in the electromagnetic environment specifiedbelow. The customer or the user of the Model
775warming unit should assure that it is used in such anenvironment.
Emissions test Compliance Electromagnetic environment -guidance
RFemissions
CISPR 11
Group 1 The Model 775warming unit uses RF energy only for its internal function. Therefore,
its RF emissions are very low and are not likely to cause any interference in nearby
electronicequipment.
RFemissions
CISPR 11
Class B The Model 775warming unit is suitable for use in all establishments, including domestic
establishments and those directly connected to the public low-voltage power supply
network that supplies buildings used for domesticpurposes.
Harmonicemissions
IEC 61000-3-2
Class A
Voltagefluctuations/
Flickeremissions
IEC 61000-3-3
Complies
Guidance and manufacturer’s declaration – electromagneticimmunity
The Model 775warming unit is intended for use in the electromagnetic environment specifiedbelow. The customer or the user of the Model
775warming unit should assure that it is used in such anenvironment.
Immunity Test IEC60601 test level Compliance level Electromagnetic environment -guidance
Electrostatic
discharge(ESD)
IEC 61000-4-2
±6kVcontact
±8kV air
±6kVcontact
±8kV air
Floors should be wood, concrete or ceramic tile. If floors are
covered with synthetic material, the relative humidity should
be at least30%.
Electrical
fasttransient/burst
IEC 61000-4-4
±2kV for power
supplylines
±1kV for input/output
lines
±2kV for power
supplylines
±1kV for input/output
lines
Mains power quality should be that of a typical commercial or
hospitalenvironment.
Surge
IEC 61000-4-5
±1kV line toline
±2kV line(s) to earth
±1kV line toline
±2kV line(s) to earth
Mains power quality should be that of a typical commercial or
hospitalenvironment.
Voltage dips, short
interruptions and
voltage variations
on power supply
inputlines
IEC 61000-4-11
<5% UT
(>95% dip in UT)
for 0,5cycle
40% UT
(60% dip in UT)
for 5cycles
70% UT
(30% dip in UT)
for 25cycles
<5% UT
(>95% dip in UT)
for 5sec
<5% UT
(>95% dip in UT)
for 0,5cycle
40% UT
(60% dip in UT)
for 5cycles
70% UT
(30% dip in UT)
for 25cycles
<5% UT
(>95% dip in UT)
for 5sec
Mains power quality should be that of a typical commercial or
hospital environment. If the user of the Model 775warming
unit requires continued operation during power mains
interruptions, it is recommended that the Model 775warming
unit be powered from an uninterruptible power supply or
abattery.
Power frequency
(50/60Hz)
magneticfield
IEC 61000-4-8
3A/m 3A/m Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial or
hospitalenvironment.
NOTE UTis the a.c. mains voltage prior to application of the testlevel.

11
GB / 34-8718-8811-0
Guidance and manufacturer’s declaration – electromagneticimmunity
The Model 775warming unit is intended for use in the electromagnetic environment specified below. The customer or the user of the Model
775warming should assure that it is used in such anenvironment.
Immunity Test IEC 60601test level Compliance
level
Electromagnetic environment -guidance
ConductedRF
IEC61000-4-6
RadiatedRF
IEC 61000-4-3
3Vrms
150kHz to 80MHz
3V/m
80MHz to 2,5GHz
3Vrms
3V/m
Portable and mobile RF communications equipment should be used no
closer to any part of the Model 775warming unit, including cables, than
the recommended separation distance calculated from the equation
applicable to the frequency of thetransmitter.
Recommended separationdistance
d =1.2
d = 1.2 80MHz to 800MHz
d = 2.3 800MHz to 2,5GHz
where P is the maximum output power rating of the transmitter in watts
(W) according to the transmitter manufacturer and d is the recommended
separation distance in meters(m).
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site surveya, should be less than the compliance level in
each frequencyrange.b
Interference may occur in the vicinity of equipment marked with the
followingsymbol:
NOTE 1 At 80MHz and 800MHz, 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.
aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio,
AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment
due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which
the Model 775warming unit is used exceeds the applicable RF compliance level above, the Model 775warming unit should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the
Model 775warmingunit.
bOver the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m.
Recommended separation distancesbetween portable and mobile RF communications equipment and the Model 775warmingunit
The Model 775warming unit is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The
customer or the user of the Model 775warming unit can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the Model 775warming unit as recommended below,
according to the maximum output power of the communicationsequipment.
Rated maximum output power of
transmitter W
Separation distance according to frequency of transmitterm
150kHz to 80MHz
d =1.2
80MHz to800MHz
d =1.2
800MHz to 2,5GHz
d =2.3
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (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.

12 3M™Bair Hugger™ Model 775 Warming Unit – Operator’s Manual
MEDICAL — GENERAL MEDICAL EQUIPMENT AS TO
ELECTRICAL SHOCK, FIRE AND MECHANICAL
HAZARDS ONLY IN ACCORDANCE WITH UL 60601-1;
CAN/CSA-C22.2, No.601.1; ANSI/AAMI
ES60601-1:2005CSA-C22.2No. 60601-1:08;
EN80601-2-35; ControlNo.4HZ8
Classified under IEC 60601-1Guidelines (and other national
versions of the Guidelines) as Class I, Type BF, Ordinary equipment,
Continuous operation. Not suitable for use in the presence of
flammable anesthetic mixtures with air or with oxygen or nitrous
oxide. Classified by Underwriters Laboratories Inc. with respect to
electric shock, fire and mechanical hazards only, in accordance with
UL 60601-1, EN 80601-2-35and in accordance with Canadian/CSA
C22.2, No. 601.1. Classified under the Medical Device Directive as a
Class IIbdevice.
DIAGNOSTICS
A qualified service technician can perform over-temperature
detection system testing, temperature output testing, operating
temperature calibration, and fault codetroubleshooting.

13
FR / 34-8718-8811-0
2Table des matières
Introduction..................................................................................................................................................................................15
Description Du Système De Gestion De La Température Bair Hugger™ 3M™......................................................15
Indications.............................................................................................................................................................................15
Dénition Des Symboles....................................................................................................................................................15
Contre-Indications, Avertissements, Mises En Garde Et Avis...........................................................................................16
Explication Des Conséquences Correspondant Aux Mentions D’avertissement ..................................................16
CONTREINDICATION : ...................................................................................................................................................16
AVERTISSEMENT :.............................................................................................................................................................16
MISE EN GARDE :...............................................................................................................................................................17
Remarques ............................................................................................................................................................................17
Utilisation Et Entretien........................................................................................................................................................17
À Lire Avant Toute Opération De Maintenance Sur L’équipement ...........................................................................17
Présentation Et Fonctionnement..............................................................................................................................................18
Mise Sous Tension Et Réinitialisation De L’appareil De Réchauement ..................................................................18
Présentation Du Panneau De Commande......................................................................................................................18
Installation De L’appareil De Réchauement Sur Une Potence À Perfusion...........................................................19
Mode D’emploi.............................................................................................................................................................................19
Achage Du Chronomètre Du Mode De Température .............................................................................................20
Procédure À Suivre En Cas De Surchaue ...................................................................................................................20
Procédure À Suivre En Cas De Panne............................................................................................................................20
Entretien Général Et Stockage .................................................................................................................................................21
Instructions De Nettoyage ................................................................................................................................................21
Stockage ...............................................................................................................................................................................21
Assistance Technique Et Commandes....................................................................................................................................21
Demande D’assistance Technique ...................................................................................................................................21
Réparation Et Échange Sous Garantie ............................................................................................................................21
Caractéristiques Techniques ............................................................................................................................................21

15
FR / 34-8718-8811-0
2Appareil de réchauffement Bair Hugger™ 3M™, modèle 775
Manuel de l’utilisateur
Introduction
Description du système de gestion de la température
BairHugger™ 3M™
Le système de gestion de la température Bair Hugger comprend un
appareil de réchauffement, modèle 775 (avec chariot fourni en option
et d’autres accessoires), une couverture de réchauffement 3M et une
chemise de réchauffement 3M, ou le kit de réchauffement du sang et
des solutés Ranger™ 3M™, modèle 241.
L’appareil de réchauffement Bair Hugger est fixé à la couverture
ou à la chemise au moyen d’un tuyau flexible. De l’air chaud est
généré dans l’appareil, et circule à travers le tuyau de l’appareil et à
l’intérieur de la couverture ou de la chemise. Selon le modèle choisi,
la couverture ou la chemise 3M est placée autour du patient, sur ou
en dessous de ce dernier. De petites perforations sur la couverture
ou la chemise permettent à l’air chaud de se diffuser sur le corps du
patient. Pour les applications impliquant le réchauffement de sang et
de solutés, le kit de réchauffement du sang et des solutés, modèle
241, est inséré dans le tuyau de l’appareil de réchauffement. Quand
l’appareil de réchauffement est allumé et qu’une température est
sélectionnée, de l’air chaud circule dans le tuyau du modèle 241 et du
liquide/sang chaud ressort de l’extrémité distale du tuyau. Pour toute
information complémentaire sur les couvertures 3M, les chemises, le
kit de réchauffement 241 ou les autres accessoires, veuillez consulter
notre site Internet à l’adresse : bairhugger.com.
Ce manuel contient les instructions d’utilisation et les caractéristiques
relatives à l’appareil de réchauffement, modèle 775. L’appareil
de réchauffement, modèle 775, peut être utilisé dans tous les
environnements cliniques dans lesquels les patients sont susceptibles
de ressentir une chaleur ou un froid excessif, notamment en salle
d’opération, afin de réguler leur température. Pour obtenir de
plus amples informations sur l’utilisation des couvertures 3M, des
chemises ou du kit de réchauffement du sang et des solutés 241
avec l’appareil de réchauffement, modèle 775, consultez le mode
d’emploiadéquat.
Indications
Le système de gestion de la température Bair Hugger est destiné à
prévenir et à traiter l’hypothermie. Par ailleurs, le système de gestion
de la température peut être utilisé pour assurer un confort thermique
aux patients lorsque les conditions environnantes peuvent entraîner
une sensation de chaleur ou de froid chez le patient. Le système de
gestion de la température convient aux adultes et aux enfants.
• Le système de gestion de la température Bair Hugger doit
uniquement être utilisé par des professionnels de santé
dûment formés.
• La loi fédérale américaine exige que ce dispositif soit vendu
ou prescrit par un professionnel de santé accrédité.
Définition des symboles
Les symboles suivants peuvent figurer sur les étiquettes ou sur
l’emballage extérieur du produit.
Un conducteur de prise de terre équipotentielle
autre qu’un conducteur de protection de mise
à la terre ou un conducteur neutre, permettant
un branchement direct entre l’équipement
électrique et le jeu de compensation de potentiel
de l’installation électrique. Veuillez consulter la
norme CEI 60601-1 pour connaître les exigences
à remplir.
Fusible
Équipement type BF (appliqué au patient)
Date de fabrication
Fabricant
Tension, courant alternatif (CA)
Ce système est soumis à la directive européenne
DEEE 2002/96/CE. Ce produit contient des
composants électriques et électroniques et
ne doit pas être éliminé dans le circuit de
collecte des déchets standard. Consulter les
directives locales relatives à la mise au rebut des
équipements électriques et électroniques.
Protection de mise à la terre
Ne pas utiliser le tuyau seul
Réglage maximum de ventilation
Réglage minimum de ventilation
Non anti-déflagrant
Consulter le mode d’emploi
Respecter le mode d’emploi
Cet appareil doit être recyclé pour éviter toute
contamination environnementale Ce produit
contient des pièces recyclables. Pour obtenir des
informations sur le recyclage, contactez le centre
de services 3M le plus proche.
Attention, consulter la notice d’utilisation
Conserver au sec
Limites de température

16 Appareil de réchauffement Bair Hugger™ 3M™, modèle 775 – Manuel de l’utilisateur
Contre-indications, avertissements, mises en garde
etavis
Explication des conséquences correspondant aux
mentionsd’avertissement
!
AVERTISSEMENT : Indique une situation dangereuse qui, si elle
n’est pas évitée, peut entraîner la mort ou des blessures graves.
!
MISE EN GARDE : Indique une situation dangereuse qui, si
elle n’est pas évitée, peut entraîner des blessures légères
oumodérées.
REMARQUE : Indique une situation qui, si elle n’est pas évitée,
pourrait provoquer des dommages matériels uniquement.
!
CONTRE-INDICATION : afin de réduire le risque de brûlures :
• N’appliquez pas de chaleur sur les membres inférieurs lors
du clampage de la crosse aortique. L’application de chaleur
au niveau des membres ischémiques peut provoquer
desbrûlures.
!
AVERTISSEMENT : afin de réduire le risque de brûlures :
• L’appareil de réchauffement Bair Hugger, modèle 775, est
conçu pour fonctionner en toute sécurité UNIQUEMENT
avec les produits à usage unique 3M. Toute utilisation avec
d’autres produits peut causer des brûlures. Dans toute la
mesure permise par la loi, le fabricant et/ou l’importateur
décline toute responsabilité en cas de brûlures résultant de
l’utilisation de l’appareil de réchauffement avec des
produits autres que ceux de la gamme 3M.
• ne traitez pas le patient directement à l’aide
du tuyau de l’appareil de réchauffement. Fixez
toujours le tuyau à une couverture/chemise
de réchauffement 3M avant de commencer
letraitement.
• Ne laissez pas le patient s’allonger sur le tuyau de l’appareil
de réchauffement.
• Ne laissez pas le tuyau de réchauffement entrer en contact
avec la peau du patient lors dutraitement.
• Ne laissez pas les nouveau-nés, les nourrissons, les enfants
et d’autres patients vulnérables sans surveillance lors
dutraitement.
• Pendant une thérapie de réchauffement prolongée, ne
laissez pas sans surveillance les patients présentant une
mauvaise perfusion.
• Ne placez pas le côté non perforé de la couverture/
chemise de réchauffement contre le patient. Placez
toujours le côté perforé (avec les petits trous) directement
sur la peau du patient.
• Ne branchez pas de couverture/chemise de réchauffement
déchirée ou endommagée à l’appareil de réchauffement.
• Au regard des couvertures et des chemises de
réchauffement intégrales, ne placez pas le dispositif
de fixation destiné au patient (c’est-à-dire, sangle de
sécurité ou ruban adhésif) sur la couverture/chemise
deréchauffement.
• Au regard des matelas ou couvertures de réchauffement
latérales, si un dispositif de fixation (c’est-à-dire, sangle de
sécurité ou ruban adhésif) est utilisé, veillez à ce que les
conduits ne soient pas obstrués.
• Ne placez pas la couverture/chemise de réchauffement
directement sur une électrode de dispersion.
• Ne poursuivez pas la thérapie de réchauffement si le
témoin de surchauffe rouge s’allume et que l’alarme
retentit. Débranchez l’appareil de réchauffement et
contactez un technicien de maintenance qualifié.
• Ne poursuivez pas la thérapie de réchauffement du sang et
des solutés 241 si le témoin de surchauffe rouge s’allume
et que l’alarme retentit. Coupez immédiatement le débit
et éliminez le kit de réchauffement du sang et des solutés.
Débranchez l’appareil de réchauffement et contactez un
technicien de maintenance qualifié.
• Au regard de la chemise de réchauffement flexible
BairHugger, veillez à ce que les fils de la manchette à
pression, de l’ECG, de la perfusion intraveineuse ou tout
autre câble ne se trouve pas entre la doublure supérieure
et la chemise avant de déployer la/les doublure(s) de
réchauffement supérieure(s), au risque de déchirer
ladoublure.
• N’effectuez pas de test du système de détection de
surchauffe lorsque l’appareil de réchauffement est utilisé
dans le cadre d’une thérapie de réchauffement.
!
AVERTISSEMENT : afin de réduire le risque de blessures ou
de décès du patient découlant d’une posologie modifiée :
• N’utilisez pas de couverture/chemise de réchauffement sur
des patchs médicamenteux transdermiques.
!
AVERTISSEMENT : afin de réduire le risque de blessures
découlant d’une interférence avec la ventilation :
• Ne laissez pas la couverture/chemise de réchauffement ou
le couvre-tête recouvrir la tête ou les voies respiratoires
du patient, à moins que ce dernier soit ventilé de
façonmécanique.
•AVERTISSEMENT : afin de réduire le risque de blessures
découlant d’une chute du patient :
• N’utilisez pas une couverture/chemise de réchauffement
pour transférer ou déplacer le patient.
!
AVERTISSEMENT : Afin de réduire les risques d’incendie et
les risques liés aux tensions dangereuses :
• Gardez le cordon d’alimentation visible et accessible en
permanence. La fiche du cordon d’alimentation permet de
couper l’alimentation.
• Branchez l’appareil uniquement sur une prise destinée à
un usage hospitalier ou équivalent ou sur une prise fiable,
reliée à la terre.
• Utilisez uniquement le cordon d’alimentation spécifique à
ce produit et homologué pour le pays d’utilisation.
• Le cordon d’alimentation ne doit pas être mouillé.
• N’utilisez pas l’appareil de réchauffement lorsque
l’appareil, le cordon d’alimentation ou tout autre élément
est endommagé. Remplacez l’appareil de réchauffement.
Contactez l’assistance technique 3M.
• Seul un technicien de maintenance qualifié est habilité à
démonter l’appareil de réchauffement. Certaines pièces à
l’intérieur de l’appareil de réchauffement sont sous tension
lorsque ce dernier est branché à une source d’alimentation.
• Branchez chaque appareil de réchauffement testé sur une
source d’alimentation individuelle.
!
MISE EN GARDE : afin de réduire le risque de
contaminationcroisée :
• À l’exception des modèles de couverture de réchauffement
Bair Hugger spécifiques, les couvertures/chemises
de réchauffement 3M ne sont pas stériles. Chaque
couverture/chemise de réchauffement doit être utilisée
EXCLUSIVEMENT sur un seul patient. L’insertion d’un drap
entre la couverture/chemise de réchauffement et le patient
n’empêche pas la contamination du produit.