3M Bair Hugger 675 User manual

Made in USA with Globally Sourced Materials
-3M Company
2510ConwayAve.,
St. Paul, MN 55144USA
1-800-228-3957 (USA Only)
3M, BAIR HUGGER and BAIR HUGGER logo are trademarks
of 3M. Used under license in Canada.
© 2021, 3M. Unauthorized use prohibited. All rights reserved.
3M, BAIR HUGGER et BAIR HUGGER logo sont des marques de
commerce de 3M, Utilisiées sous licence au Canada.
© 2021, 3M. Toute utilisation non autorisée est interdite. Tous droits reserves.
Issue Date: 2021-10, rev. 8
34-8727-8204-9
3M Deutschland GmbH
Health Care Business
Carl-Schurz-Str. 1
41453 Neuss, Germany
aWarming Unit Model675 Operator’s Manual
bManuel d’utilisation de l’unité de réchauffement
modèle 675
cBenutzerhandbuch zur Wärmeeinheit, Modell 675
dUnità riscaldante modello 675 - Manuale d’uso
eManual del operador de la unidad de
calentamiento modelo 675
kManual do Operador da Unidade de Aquecimento
Modelo 675
lΕγχειρίδιο Χρήστη Μονάδας Θέρμανσης,
Μοντέλο 675
mAparat do terapii grzewczej Model 675 —
instrukcja obsługi
oOhřívací jednotka, model 675 – Návod k obsluze
t675 modelio šildymo įrenginio operatoriaus
vadovas
vРуководство по эксплуатации устройства
для обогрева, модель 675
1Isıtma Üntes Model 675 Kullanım Kılavuzu
4675 型加温器操作手册
7  675   
675

Description:
Base File Name:
Software:
SGS Contact:
Email:
Printer:
Printer Location:
Supplier:
Bair Hugger Warming Unit - IFU
Requester: Frank Boeshart
Reference:
Die # / Doc. Size: 8.5” x 11”
Item Spec#: 34-8727-8204-9
Supersedes#:
Cat/Product#:
Structure#:
MD675
PA: 34872782049.indd
GA:
InDesign CC
PROCESS
BLACK
PANTONE
294C 3M RED
6595581-1 6
09.11.21 Update as per annotations & symbol chart SM
29.11.21 Update as per Brief SR
07.12.21 Update as per annotation SM
09.12.21 Rx content only update for all languages SM
12.24.21 Update as per annotation GA
12.28.21 Final Release kat
675
aEnglish ................................................... 1
bFrançais...............................................15
cDeutsch..............................................29
dItaliano................................................45
eEspañol...............................................59
kPortuguês...........................................73
lΕλληνικά ...........................................87
mPolski ................................................103
oČeština .............................................. 117
tLietuviskai......................................... 131
vРУССКИЙ ......................................145
1Turkce................................................161
4简体中文 ....................................... 175
7 ................................................. 187

1
aTable of Contents
Product Description of the 3M™ Bair Hugger™ Temperature Management System ................................................... 3
Indications for Use ............................................................................................................................................................... 3
Patient Population and Settings ........................................................................................................................................ 3
Contraindications, Warnings, Cautions and Notices............................................................................................................ 3
Explanation of Signal Word Consequences.................................................................................................................... 3
CONTRAINDICATIONS...................................................................................................................................................... 3
WARNINGS ........................................................................................................................................................................... 3
CAUTIONS............................................................................................................................................................................. 4
Notices ................................................................................................................................................................................... 4
Using the Model675 Bair Hugger Warming Unit .................................................................................................................. 5
Overview of Model675 Warming Unit............................................................................................................................ 5
Overview of Control Panel................................................................................................................................................. 5
Important Alarm Symbols and Indicators........................................................................................................................ 5
Filter time limit has been reached:.................................................................................................................................... 6
Instructions for Use...................................................................................................................................................................... 6
Caution: .......................................................................................................................................................................................... 6
Connecting the Warming Unit Hose and Power Cord .........................................................................................................7
Connecting the Warming Unit Hose to the Warming Unit............................................................................................7
Connecting the Power Cord to the Warming Unit..........................................................................................................7
Warming Unit Mounting Instructions........................................................................................................................................7
Mounting on IV Pole .............................................................................................................................................................7
Mounting onto Rolling Cart Accessory ............................................................................................................................7
Cleaning, Storage, and Maintenance........................................................................................................................................7
Cleaning Instructions ...........................................................................................................................................................7
Storage ....................................................................................................................................................................................7
Maintenance: Filter...............................................................................................................................................................7
Proper Use and Maintenance............................................................................................................................................. 8
Diagnostics ........................................................................................................................................................................... 8
Read Before Servicing Equipment .................................................................................................................................... 8
In-Warranty Repair and Exchange............................................................................................................................................ 8
USA: ........................................................................................................................................................................................ 8
Outside of the USA: ............................................................................................................................................................. 8
Symbol Glossary........................................................................................................................................................................... 8
Specifications...............................................................................................................................................................................10
Physical Characteristics.....................................................................................................................................................10
Recommended operating environment .........................................................................................................................10
Operating temperatures ....................................................................................................................................................10
Safety System ......................................................................................................................................................................10
Alarm/Fault Codes..............................................................................................................................................................10
Electrical Characteristics....................................................................................................................................................11
Classifications..............................................................................................................................................................................13
Frequently Asked Questions (FAQ) on Filtration ..................................................................................................................14
What filter is used in the 3M™ Bair Hugger™ Model 675 warming unit? ..............................................................14
What is a MERV rating? .....................................................................................................................................................14
What is the MERV rating recommended for operating rooms?.................................................................................14
What is the MERV rating recommended for patient warming devices in the operating room? .........................14
Is a HEPA filter necessary? ...............................................................................................................................................14
What is the ASHRAE 52.2-2012 standard? ...................................................................................................................14
References:...................................................................................................................................................................................14

3
a3M™ Bair Hugger™ Warming Unit Model 675
Operator’s Manual
675
Product Description of the 3M™ Bair Hugger™
Temperature Management System
The Bair Hugger temperature management system consists of
a Model 675 warming unit (with optional rolling cart and other
accessories) along with a 3M warming blanket or a Bair Hugger
warming gown.
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 unit and flows through the warming unit hose into the blanket or
gown. Depending on the model, the 3M blanket or gown is placed
either over, around or underneath the patient. Small perforations
on the blanket or gown allow the warm air to be dispersed over the
patient’s skin.
This manual includes operating instructions and warming unit
specifications for the Model 675 warming unit. You can use the
Model 675 warming unit in 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
Bair Hugger warming blankets or gowns with the Model 675 warming
unit, refer to the respective Instructions for Use.
Indications for Use
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.
Patient Population and Settings
Adult and pediatric patients being treated in operating rooms,
emergency departments and other departments in the hospital
setting where patient temperature management is required.
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.
CONTRAINDICATIONS
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.
WARNINGS
WARNING: To reduce the risk of thermal injury:
• The Bair Hugger warming unit Model 675 has been designed to
operate safely ONLY with 3M disposable warming blankets and
gowns. 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 warming
blankets and gowns.
• 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 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 place the warming blanket/gown directly over a
dispersive electrode pad.
• 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.
• 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 allow the patient to lie on the warming unit hose.
• Do not allow the warming unit hose to directly contact the
patient’s skin during warming therapy.
• Do not connect a torn or damaged warming blanket/gown to the
warming unit.
• Do not leave patients with poor perfusion unmonitored during
prolonged warming therapy.
• Do not leave neonates, infants, children, and other vulnerable
patient populations unattended during warming therapy.
• Do not continue warming therapy if the red Over-temp symbol
illuminates and the alarm sounds. Unplug the warming unit and
contact a qualified service technician.
• 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.

4
• Use only the 3M-supplied power cord intended 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. Contact 3M
TechnicalSupport.
• Do not disassemble the temperature management unit unless you
are a qualified service technician. There are electrically live parts
within the unit when it is connected to a power source.
• Connect each warming unit being tested to a separate
powersource.
• Do not attempt to replace the filter while the warming unit is
inuse.
CAUTIONS
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.
• Follow applicable regulations when disposing of this warming unit
or any of its electrical components.
• Clean the warming unit and the outside of the warming unit
hose after each patient use. See “Cleaning Instructions” in the
Cleaning Instructions section. 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 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 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.
• Do not place the warming unit and rolling cart on an inclined
surface of more than 7 degrees with rear casters facing
downward angle.
• Do not attempt to move the rolling cart when the front casters
arelocked.
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.
• 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. The Model 22110 temperature
test unit itself requires no calibration.
• Only use 3M-supplied power cord with the warming 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.
5
Using the Model675 Bair Hugger Warming Unit
Overview of Model675 Warming Unit
Control
Panel Carrying Handle IV Pole Clamp
Warming Unit
Hose
675
Power
Cord Warming Unit Hose
Front
Equipotential
Stud Back
Overview of Control Panel
Display Screen (LCD):
• Shows temperature of air coming out
of the hose
Temperature Settings:
•(Ambient)
•32° C (89.6° F)
•38° C (100.4° F)
•43° C (109.4° F)
Green LED:
• Shows selected temperature setting
Power:
• Green = On
• Amber = Standby
Important Alarm Symbols and Indicators
(The Model 675 unit’s visual and audible alarms are classified as Low Priority per IEC 80601-2-35):
•Stop use: Service required
•Audible alarm will sound: To silence the alarm press the Power button.
•Do not re-start
Service required Red
over-temperature
Blue
under-temperature