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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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

Bair Hugger Model 505 Temperature Management Unit Operator’s Manual English 9
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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.

10 English Bair Hugger Model 505 Temperature Management Unit Operator’s Manual
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General Maintenance
Cabinet Cleaning
Disconnect the temperature management unit from the power source before cleaning.1.
Use a damp soft cloth and a mild detergent to clean the unit cabinet. Dry with a separate soft2.
cloth.
Caution
Do not use a dripping wet cloth to clean the cabinet. Moisture may seep into the electrical•
contacts, damaging the components.
Do not use alcohol or other solvents to clean the cabinet. Solvents may damage the labels and•
other plastic parts.
Technical Service and Order Placement
, 
Tel: [phone] Fax: [phone]
1-800-733-7775
 
Tel: [phone] Fax: [phone]
0800-100-1236
(Toll-free in Germany)
0800-100-1324
(Toll-free in Germany)
In-Warranty Repair and Exchange
Replacement parts to correct a problem are delivered at no charge. To return a device to Arizant
Healthcare Inc. for service, first obtain a Return Authorization (RA) number from a technical
service representative. Please use this number on all correspondence when returning a device for
service. A shipping carton will be delivered to you at no charge, if needed. Call your local supplier
or sales representative to inquire about loaner devices while your device is being serviced.
When You Call for Technical Support
Remember, we will need to know the serial
number of your unit when you call us. On Model
505 units, the serial number label is affixed to
the rear panel.
Figure J. Serial number label on Model 505
Serial number label

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Specifications
Physical Characteristics
 13 in. high x 10 in. deep x 11 in. wide
33 cm high x 25 cm deep x 28 cm wide
 13.6 lb; 6.2 kg
 IV pole clamp, bedrail hook with safety strap; can be
placed on hard surface
   53 decibels
 Detachable, flexible, washable; compatible with the
241 fluid warming system
  0.2µM level
   Every 6 months or 500 hours of use.
Temperature Characteristics
  Electronically controlled using a thermocouple sensor
  1800 BTUs (average)
   °F (.°C) ~17 secs
  Air temperatures reaching the patient are
approximately 2°C lower than the listed temperatures.
Average temperatures at the end of the hose:
HIGH: 43°C ± 3°C 109.4°F ± 5.4°F
MED: 38°C ± 3°C 100.4°F ± 5.4°F
LOW: 32°C ± 3°C 89.6°F ± 5.4°F

12 English Bair Hugger Model 505 Temperature Management Unit Operator’s Manual
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Safety System
 Independent bulb and capillary
  Dual fused input lines
  Over-heat: flashing red light with audible alarm;
heater shuts down
 IEC 60601-1; EN 60601-1-2; UL 60601-1; CAN/
CSA-C22.2, No. 601.1, EN 55011; ASTM F2196-02
 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, ASTM
F2196-02, and Canadian/CSA C22.2, No. 601.1.
Electrical Characteristics
  Operating speed: 3150 rpm
Airflow: 28-30 cfm
  Peak: 1000W
Average: 450W
  <100µA
  850W Resistive
  15-foot, SJT, 3 cond., 10A
4.6 meter, HAR, 3 cond., 10A
  110-120 VAC, 60 Hz, 9.5 Amperes, or
220-240 VAC, 50 Hz, 4.5 Amperes, or
100 VAC, 50/60 Hz, 10 Amperes
 10A, 200mA (110 - 120 VAC Units)
6.3A, 100mA (220 - 240 VAC Units)
15A, 160mA (100 VAC Units)
 Over-heat test can be performed by the biomedical
group.

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Definition of Symbols
ON/STANDBY
ON (used on isolation switch)
OFF (used on isolation switch)
ON/OFF push button switch
Temperature Control
Equipotentiality plug (Ground)
Fuse
Attention (see appropriate documents)
Dangerous Voltage
Type BF Equipment (patient applied)
Voltage, Alternating Current (AC)
Special Refuse, discard separately
Protective earth ground
No free hosing
!
VAC
V

10393 West 70th Street, Eden Prairie, MN 55344 USA
TEL [phone] • 952-947-1200 | FAX [phone] • 952-947-1400
www.bairhugger.com
Authorized Representative in the European Community:
Arizant UK Limited, Calder Island Way, Wakefield, WF2 7AW, United Kingdom
TEL [phone] | FAX [phone]
Bair Hugger temperature management products may be covered by one or more of the following patents: US 7,101,389;
6,355,915; 6,309,409; 6,309,408; 6,290,716; 6,254,337; 6,241,755; 6,228,107; 6,203,567; 6,176,870; 6,168,612;
6,146,412; 6,129,936; 6,126,681; 6,126,393; 6,036,722; 5,997,572; 5,964,792; 5,928,274; 5,824,025; 5,800,489;
5,773,275; 5,733,318; 5,697,963; 5,674,269; 5,658,325; 5,620,482; 5,545,194; RE38462; 5,350,417; 5,336,250;
5,324,320; 5,300,102; 5,300,101; 5,184,612; 5,044,361; Canada 1,325,484; Australia 756,900; Other patents pending.
*Bair Hugger, 241, Total Temperature Management, Arizant, Arizant Healthcare, bright ideas that work, and the
Bair Hugger and Arizant logos are trademarks of Arizant Healthcare Inc., registered or pending in the U.S. Patent &
Trademark Office and in other countries.
©2009 Arizant Healthcare Inc. All rights reserved. 200977E 03/09