Bair Hugger 505 User manual

Betriebshandbuch für Bair Hugger*
Temperaturmanagement-Geräte
Modell 505
Manuel de l’utilisateur pour les
appareils de gestion de la température
Bair Hugger* Modèle 505
Manuale d’uso delle unità di gestione
della temperatura Bair Hugger*
Modello 505
Manual del usuario para las
unidades de control de temperatura
Bair Hugger*, Modelo 505
Manual do utilizador das unidades de
gestão de temperatura Bair Hugger*
Modelo 505
Bair Hugger* Temperatuurregelunit
Model 505 Gebruikshandleiding
Brugsanvisning til Bair Hugger*
temperaturreguleringsenheder,
Model 505
Bruksanvisning till Bair Hugger*
Modell 505 temperaturstyrenhet
Brukerhåndbok for Bair Hugger*-
temperatur-behandlingsenhet,
Modell 505
Bair Hugger* -lämpötilansäätölaitteen
Malli 505 käyttäjän opas
Εγχειρίδιο Χρήσης Bair Hugger*
Μονάδα διαχείρισης θερμοκρασίας,
Μοντέλο 505
取 扱 説 明 書 ベ アーハ ガー モ
デル505体温管理装置
Instrukcja Obsługi Dmuchawy
Bair Hugger* Model 505 - urządzenia
do aktywnego przeciwdziałania
hipotermii
Bair Hugger* 505 sz. Modell
hőmérséklet-szabályozó egység
használati utasítása
Návod k obsluze jednotky regulace
teploty Bair Hugger* typ 505
Operatoriaus Vadovas „Bair Hugger“*
Modelis 505 Temperatūros reguliavimo
prietaisas
Руководство по эксплуатации
Bair Hugger* Mодель 505 Устройство
управления температурой
操作员手册 505型
Bair Hugger* 温度管理仪
Total Temperature Management System
Bair Hugger*
Temperature Management Unit
Model 505
Operator’s Manual
Check the Bair Hugger therapy website to ensure you have the most recent version of this document. www.bairhugger.com reorder #200977E

Bair Hugger*
Temperature Management Unit
Model 505
Operator’s Manual
English 1
Deutsch 15
Français 29
Italiano 43
Español 57
Português 71
Nederlands 85
Dansk 99
Svenska 113
Norsk 127
Sumoi 141
Ελληνικά 155
日本語 169
Polski 183
Magyar 197
Česky 211
Lietuvių Kalba 225
Русский 237
英语 249

Table of Contents
Introduction������������������������������������������������������ 3
Description of the Total Temperature Management* System ................ 3
Indications ........................................................ 3
Contraindications................................................... 3
Warnings.......................................................... 4
Cautions .......................................................... 4
Notices ........................................................... 5
Read Before Servicing Equipment...................................... 5
Set up and Operation ���������������������������������������������� 6
Temperature Management Unit ....................................... 7
Control Panel Features of the Model 505 Temperature Management Unit ..... 7
Mounting the Model 505 Temperature Management Unit.................. 8
Attaching and Storing the Model 505 Unit Hose.......................... 9
General Maintenance ��������������������������������������������� 10
Technical Service and Order Placement ������������������������������ 10
In-Warranty Repair and Exchange .................................... 10
When You Call for Technical Support ................................. 10
Specifications ���������������������������������������������������� 11
Definition of Symbols��������������������������������������������� 13

Bair Hugger Model 505 Temperature Management Unit Operator’s Manual English 3
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Introduction
Description of the Total Temperature Management* System
The Bair Hugger* brand Total Temperature Management system consists of a Bair Hugger forced-
air temperature management unit (with available rolling stand and sheet clip) and disposable
components, including Bair Hugger forced-air blankets, Bair Paws* patient warming gowns, and
the 241* blood/fluid warming set. You can use the Model 505 temperature management unit in all
clinical settings including the operating room to provide patient temperature management.
This manual includes operating instructions and unit specifications for the Model 505 forced-
air temperature management unit. For information about using Bair Hugger blankets, Bair Paws
gowns, or the 241 blood/fluid warming set with Bair Hugger units, refer to the “Instructions for
Use” included with each of these disposable components.
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 become too warm or too cold. The temperature
management system can be used with adult and pediatric patients.
Contraindications
Do not apply heat to lower extremities during aortic cross-clamping. Thermal injury may occur if
heat is applied to ischemic limbs.

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Warnings
Do not leave patients with poor perfusion unmonitored during prolonged warming therapy1.
sessions. Thermal injury may result.
The Bair Hugger temperature management unit has been designed to operate safely ONLY2.
with Arizant Healthcare* disposable components. 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 unit being used in conjunction with non-
Arizant Healthcare products.)
3. Do not warm patients with the temperature management unit hose alone. Thermal
injury may result. Always connect the hose to a Bair Hugger blanket or Bair Paws
gown before providing therapy.
Do not place the non-perforated side of the blanket on the patient. Thermal injury may result.4.
Always place the perforated side (that is, with small holes) towards the patient.
Do not continue temperature management therapy if the over-temp indicator light illuminates5.
and the alarm sounds. Thermal injury may result. Unplug the unit, and contact a qualified
service technician.
Do not continue 241 blood/fluid warming therapy if the over-heat indicator light illuminates6.
and the alarm sounds. Immediately stop fluid flow, and discard the blood/fluid warming set.
Unplug the temperature management unit, and contact a qualified service technician.
Do not use a forced-air warming device over transdermal medication. Increased drug delivery7.
and patient injury or death may occur.
Do not allow the patient to lie on the warming unit hose or allow the hose to directly contact8.
the patient’s skin during patient warming; thermal injury may result. Equipment not suitable
for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous
oxide.
Resuable blankets made from woven fabric, or blankets without discrete, visible holes, can cause9.
the safety system of this unit to fail, which may result in serious thermal injury. This warming
unit has been designed to operate safety ONLY with Bair Hugger blankets or Bair Paws gowns.
Cautions
Except for specific blanket models, Bair Hugger blankets are not sterile and are all intended for1.
single patient use ONLY. Placing a sheet between the Bair Hugger blanket and the patient does
not prevent contamination of this product.
Monitor the temperature and cutaneous response of patients who are incapable of reacting,2.
communicating and/or who are without a sense of feeling every 10-20 minutes or according
to institutional protocol. Monitor the patient’s vital signs regularly. Adjust air temperature
or discontinue therapy when the therapeutic goal is reached or if vital sign instability occurs.
Notify physician of vital sign instability immediately.
Do not leave pediatric patients unattended during therapy.3.
Do not initiate temperature management therapy unless the temperature management unit is4.
safely placed on a hard surface or securely mounted. Otherwise, injury may result.
To prevent tipping, clamp the Model 505 temperature management unit to an IV pole at a5.
height that provides stability. We recommend clamping the unit no higher than 44 in. (112 cm)
from the floor on an IV pole with a minimum 28 in. (71 cm) diameter wheelbase. Failure to do
so may result in IV pole tipping, catheter site trauma, and the patient injury.

Bair Hugger Model 505 Temperature Management Unit Operator’s Manual English 5
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Electrical shock hazard. Do not disassemble the temperature management unit unless you6.
are a qualified service technician. There are electrically live parts with in the unit when it is
connected to a power source, even when the unit is in Standby mode.
Notices
The Bair Hugger temperature management unit meets medical electronic interference1.
requirements. If radio frequency interference with other equipment should occur, connect the
unit to a different power source.
Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare2.
professional.
To reliably ground this Bair Hugger warming unit, only connect to receptacles marked3.
“Hospital Only” or “Hospital Grade”.
Read Before Servicing Equipment
The repair, calibration, and servicing of the temperature management unit requires the skill of
qualified technical personnel who are familiar with good practice for medical device repair. If
service is designated as not requiring the manufacturer’s attention, the technical information is
provided in the Service Manual or will be provided upon request by Arizant Healthcare Inc.
   
Perform all repairs and maintenance in accordance with the instructions in the Service Manual.
 
Perform a safety inspection after making repairs to the temperature management unit and before
returning the unit to service. A safety inspection must include a test of the operating temperatures
(described in the Service Manual), the Over Heat Alarm system, as well as a leakage current test.
   
Arizant Healthcare Inc. assumes no responsibility for the reliability, performance, or safety of the
equipment if:
Modifications or repairs are performed by unauthorized personnel.•
The equipment is used in a manner other than that described in the Operation or Service•
Manuals.
The equipment is installed in an environment that does not meet the relevant grounding•
requirements.

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Set up and Operation
The Bair Hugger brand Total Temperature Management system is easy to set up and to use.
Follow the instructions provided with each Bair Hugger blanket or Bair Paws gown for specific
information.
Place the blanket or gown on the patient with the perforated side (the side with small holes)1.
against the patient’s skin.
Insert the hose of the temperature management unit in2.
the hose port on the blanket or gown. Use a twisting
motion to ensure a snug fit (see Figure A).
Connect the unit to a properly grounded power source.3.
Press the System ON/OFF button to turn the unit ON4.
and select the appropriate temperature setting.
You may place a cotton blanket over the blanket or gown5.
for maximum effectiveness.
Monitor the temperature and cutaneous response of6.
patients who are incapable of reacting, communicating and/or who are without a sense of
feeling every 10-20 minutes or according to institutional protocol. Monitor the patient’s vital
signs regularly.
Figure A.
Figure C. Model 505 unit attached to
an IV pole
Figure B. Model 505 unit attached to a
bedrail

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Temperature Management Unit
The temperature management unit uses a high-efficiency motor, a heating element, and a solid-state
temperature control to create a continuous flow of warm air to the blanket or gown. It is designed
for safe use in all areas, including the operating room.
The Model 505 temperature management unit can be attached to an IV pole or to the railing on a bed.
Control Panel Features of the Model 505
Temperature Management Unit
   
The temperature in range indicator illuminates when the output air temperature is within the range
of the selected level.
  
The main power indicator illuminates when the unit is connected to a power source. This indicator
must be illuminated for any functions to operate.
 /
Push this button to turn the unit either ON or OFF. The indicator directly above the switch
illuminates when the unit is ON.
  
The Over Heat Indicator illuminates and an audible alarm sounds when an over-temperature
condition is detected. To reset, turn the unit OFF and then ON, using the System ON/STANDBY
button. (Also refer to the Warnings section of this manual.)
 
The temperature indicators illuminate up to the selected temperature level. When the unit is
initially turned on, none of these indicators are illuminated and ambient air will be delivered.
 
Push this button to increase the temperature setting level by level to the desired setting. When the
temperature setting is at HIGH, push the button again to return to delivery of ambient air.
Figure D. Control panel of the Model 505 unit

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Arizant Healthcare Inc.
Mounting the Model 505 Temperature Management Unit
   
The Model 505 unit clamps easily to an IV pole (see Figure E). Simply turn the handle clockwise to
tighten the clamp onto an IV pole, counterclockwise to release.
Warning: To prevent tipping, clamp the Model 505 temperature management unit to an IV pole at
a height that provides stability. We recommend clamping the unit no higher than 44 in. (112 cm)
from the floor on an IV pole with a minimum 28 in. (71 cm) diameter wheelbase. Failure to do so
may result in IV pole tipping, catheter site trauma, and the patient injury.
  
The Model 505 unit can also hang on the edge of a bed. The safety strap is designed to loop
around the bedrail, keeping the Model 505 unit safely suspended even if the unit is inadvertently
dislodged from the bedrail (see Figure F).
≥28 in. (71 cm)
≤44 in.
(112 cm)
Figure E. Model 505 unit attached to an IV pole Figure F. Model 505 unit attached to a bedrail
Safety strap

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Figure G. Attaching the Model 505 unit hose Figure H. Storing the Model 505 unit hose
Hang hose clip tab
in this slot for storage
Press this tab
to release hose
Insert flange in
groove and snap
into place
Attaching and Storing the Model 505 Unit Hose
The Model 505 unit has a unique “snap-fit” hose. This extended-length swivel hose, adapted for
241 fluid warming, attaches by inserting the flange end at a 45° angle in the grooved blower outlet
and snapping the hose into place.
Press the white tab on the blower outlet to release the hose.
When storing the Model 505 unit, insert the hose clip tab in the hanger slot near the blower outlet.