Nellcor 500 User manual

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Bair Hugger*Model 500/OR
Temperature Management Unit

Operator’sManual

2 Bair Hugger Model 500/OR Temperature Management Unit Operator’s ManualEnglish

Table of Contents

Introduction

Description of the Total Temperature Management* System

Indications for Use

Contraindications

Warnings

Precautions

Important Information

Read Before Servicing Equipment

Setup and Operation

Te mperature Management Units

Control Panel Features of the Model 500/OR Temperature Management Unit

Isolation Switch

Optional Features: IV Pole, Blanket Dispenser, Hose Assemblies

General Maintenance

Cabinet Cleaning

Technical Service and Order Placement

In-Warranty Repair and Exchange

When You Call for Technical Support

Specifications

Definition of Symbols

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Bair Hugger Model 500/OR Temperature Management Unit Operator’s Manual 3

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 Bair Hugger dispos­able components, including forced-air blankets and the 241* blood/fluid warming set. The system is
intended for use in all clinical settings including the operating room.

This manual includes operating instructions and unit specifications for the Model 500/OR forced-air
temperature management unit. For information about using Bair Hugger blankets 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 for Use

The Bair Hugger brand Total Temperature Management system is intended to prevent and treat
hypothermia and to provide warmth to cold or shivering patients. In addition, the system should be
used whenever conditions exist that could cause patients to become cold.

Contraindications

Do not apply heat to lower extremities during aortic cross-clamping. Thermal injury may occur if
heat is applied to ischemic limbs.

Warn ings

• Do not use Bair Hugger units with any forced-air blanket or cover other than Bair Hugger
blankets. Thermal injury may result.

• Do not warm patients with the Bair Hugger unit hose alone. Thermal injury may result. Always
attach the hose to a Bair Hugger blanket before providing skin surface warming therapy.

• Do not continue therapy if the Over Heat warning light illuminates and the audible alarm sounds.
Thermal injury may result. Turn the temperature management OFF and contact qualified technical
personnel. If using 241 fluid warming, immediately stop fluid flow and discard the fluid warming set.

Precautions

• Monitor the patient’s temperature at least every 10 to 20 minutes, and monitor the patient’s vital
signs regularly. Reduce air temperature or discontinue therapy when the therapeutic goal is reached
or if vital sign instability occurs. Notify physician immediately of vital sign instability.

• To prevent suffocation from misuse, do not leave children or infants unattended when administering
Bair Hugger therapy.

• See CONTRAINDICATIONS and WARNINGS before administering therapy. Read this
Operator’s Manual, blanket instructions and 241 fluid warming set package instructions before use.

Important Information

EXPLOSION HAZARD

Do not use in the presence of flammable anesthetics.

4 Bair Hugger Model 500/OR Temperature Management Unit Operator’s ManualEnglish

ELECTRICAL SHOCK HAZARD

Do not disassemble the temperature management unit; refer to authorized technical personnel. There
are electrically live parts within the unit when it is connected to the power source, even when the
switches are in the OFF position.

ELECTRICAL INTERFERENCE

If radio frequency interference with monitoring equipment should occur, connect the temperature
management unit to a different power source.

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.

REFER TO SERVICE MANUAL

Perform all repairs and maintenance in accordance with the instructions in the Service Manual.

SAFETY INSPECTION

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.

PROPER USE AND MAINTENANCE

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.

Setup and Operation

The Bair Hugger brand Total Temperature Management system is easy to set up and to use. Follow
the instructions provided with each blanket for specific information.

1) Place the Bair Hugger blanket on the patient with the perforated side (the side with small holes)
against the patient’s skin.

2) Insert the hose of the temperature management unit in the hose port on the blanket. Use a
twisting motion to ensure a snug fit (see Figure A).

Figure A.

3) Connect the unit to a properly grounded power source.

4) Turn the Isolation Switch to the ON position (see the section titled Isolation Switch).

5) Press the System ON/OFF button to turn the unit ON and select the appropriate
temperature setting.

6) Place a cotton blanket over the Bair Hugger blanket for maximum effectiveness.

7) Monitor the patient’s temperature at least every 10 to 20 minutes and adjust the temperature
setting of the unit as required.

Te mperature Management Units

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. Model 500/OR is
designed for safe use in all areas, including the operating room.

The folding handle on the Model 500/OR unit can be placed in two positions. The handle is moved
forward and down for the folded position; it is pushed up and back for the upright position. In the
folded position the unit can be rolled out of the way (for example, under the operating table) during
warming therapy, and it can be stored more conveniently when warming therapy is completed. The
upright position allows the unit to be easily transported between clinical areas.

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Bair Hugger Model 500/OR Temperature Management Unit Operator’s Manual 5

Figure B. Model 500/OR temperature
management unit

Folding handle

6 Bair Hugger Model 500/OR Temperature Management Unit Operator’s ManualEnglish

Control Panel Features of the Model 500/OR Temperature Management Unit

OVER HEAT INDICATOR

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, either by the System ON/OFF but­ton (see Figure C), or by the Isolation Switch (see the section titled Isolation Switch. Also refer to the
Wa rnings section of this manual.)

TEMPERATURE INDICATORS

The indicator bar illuminates up to the selected temperature level. When the unit is initially turned
on, the AMBIENT temperature level is automatically selected.

TEMPERATURE SELECT

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 the setting to AMBIENT.

SYSTEM ON/OFF

Push this button to turn the unit either ON or OFF. The indicator directly above the switch
illuminates when the unit is ON.

MAIN POWER INDICATOR

The main power indicator illuminates when main power is applied to the unit and the Isolation
Switch is in the ON position (see the section titled

Isolation Switch). This indicator must be

illuminated for any functions to operate.

®









Figure C. Control panel of
the Model 500/OR
temperature management
unit

Isolation Switch

The isolation switch allows you to disconnect the temperature management unit from the power
source without removing the power cord from the wall receptacle. The isolation switch is located on
the back of the Model 500/OR unit. The isolation switch must be in the ON position before the
unit will operate.

Optional Features

This section discusses optional features for Bair Hugger temperature management units. For more
details about these features, please call Arizant Healthcare Inc. or your local distributor.

IV P

OLE

Model 500/OR unit has a port that accommodates an Arizant HealthcareTMIV pole.

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Bair Hugger Model 500/OR Temperature Management Unit Operator’s Manual 7

Isolation switch

Figure D. Isolation Switch on the
Model 500/OR unit

Figure E. Temperature management
unit with IV pole option

IV pole

BLANKET DISPENSER

The blanket dispenser is available for use on the Series 500 units. This dispenser attaches to the unit
and can store several Bair Hugger blankets. See the package instructions for details.

Standard length without swivel option
(replacement only)

Standard length with swivel option
(replacement only)

Extended length with swivel option
(note keyway)

Standard length 241 fluid warming hose
(replacement for 500 series only)

Extended length 241 fluid warming hose
(note keyway) (standard for 500 series only)

H

OSE ASSEMBLIES

Te mperature management hose assemblies are available in five options. The keyway on the extended
length hose matches a keyway on units specifically calibrated for the extended length hose option, to
ensure the delivery of proper temperature to the patient.

General Maintenance

Cabinet Cleaning

1) Disconnect the temperature management unit from the power source before cleaning.

2) Use a damp soft cloth and a mild detergent to clean the unit cabinet. Dry with a separate
soft 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.

8 Bair Hugger Model 500/OR Temperature Management Unit Operator’s ManualEnglish

Figure F. Hose assemblies

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Bair Hugger Model 500/OR Temperature Management Unit Operator’s Manual 9

Technical Service and Order Placement

USA, WORLDWIDE

TEL: [phone] FAX: [phone]

1-800-733-7775

WITHIN EUROPE

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 the Model
500/OR unit the serial number label is affixed to the galvanized pan on the underside of the unit.

Serial number label

Figure G. Serial number label on
Model 500/OR

10 Bair Hugger Model 500/OR Temperature Management Unit Operator’s ManualEnglish

Specifications

500/OR

Physical Characteristics

DIMENSIONS 24 in. high x 16 in. deep x 14 in. wide

61 cm high x 41 cm deep x 36 cm wide

WEIGHT 43 lb; 19.5 kg

MOUNTING Supplied with swivel casters; floor use only

RELATIVE NOISE LEVEL 52 decibels

HOSE Detachable, flexible, washable; compatible with the 241

fluid warming system

FILTRATION SYSTEM 0.2µM level

RECOMMENDED FILTER CHANGE Every 6 months or 500 hours of use

Te mperature Characteristics

TEMPERATURE CONTROL Electronically controlled using a thermocouple sensor

HEAT GENERATED 1800 BTUs (average)

SYSTEM TIME TO 100°F (37.7°C) ~35 secs

OPERATING TEMPERATURES Air temperatures reaching the patient are approximately 2°C

lower than the listed temperatures.

Average temperatures at the end of the hose, assuming the
back pressure of a Bair Hugger warming blanket, or an
Arizant Healthcare temperature test unit:

HIGH: 43° ± 3°C 109.4° ± 5.4°F
MED: 38° ± 3°C 100.4° ± 5.4°F
LOW: 32° ± 3°C 89.6° ± 5.4°F

Safety System

THERMOSTAT Independent bulb and capillary

OVERCURRENT PROTECTION Dual fused input lines

ALARM SYSTEM Over-heat: flashing red light with audible alarm; heater

shuts down

CERTIFICATIONS UL 544, CSA C22.2 No. 125, IEC 601-1, IEC 601-1-2,

EN55014, AS 3200.1990

CLASSIFICATION Classified under IEC 601-1 Guidelines as Class I, Type BF,

Ordinary equipment, Continuous operation

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Bair Hugger Model 500/OR Temperature Management Unit Operator’s Manual 11

Electrical Characteristics

BLOWER MOTOR Operating speed: 2650 rpm

Airflow: 28-30 cfm

POWER CONSUMPTION Peak: 1000W Average: 500W

LEAKAGE CURRENT <100µA

HEATING ELEMENT 850W Resistive

POWER CORD 15-foot, SJT, 3 cond., 10A

4.6 meter, HAR, 3 cond., 10A

DEVICE RATINGS 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

FUSES 10A, 200mA and 500mA (110 - 120 VAC Units)

6.3A, 100mA and 500mA (220 - 240 VAC Units)
10A, 160mA and 400mA (100 VAC Units)

DIAGNOSTICS Over-heat test can be performed by the biomedical group.

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ON/STANDBY

ON (used on isolation switch)

OFF (used on isolation switch)

ON/OFF push button switch

Te mperature Control

Equipotentiality plug (Ground)

Fuse

Attention (see appropriate documents)

Non Explosion-Proof

Dangerous Voltage

Ty pe BF Equipment (patient applied)

Vo ltage, Alternating Current (AC)

!

VAC
V

Definition of Symbols

Authorized Representative in the European Community
(as defined in Article 14 of the Medical Device Directive: 93/42/EEC):
Actamed Limited, Calder Island Way, Wakefield, WF2 7AW,
United Kingdom • TEL + 44 1924 200550 • FAX + 44 1924 200518

*Arizant, Arizant Healthcare, bright ideas that work, Bair Hugger, 241, Total
Te mperature Management, and the Bair Hugger and Arizant logos are trade­marks of Arizant Healthcare Inc., registered or pending in the U.S. Patent &
Tr ademark Office and in other countries.

Bair Hugger temperature management products may be covered by one or
more of the following patents: US 6,355,915; 6,309,409; 6,309,408;
6,290,716; 6,287,327; 6,254,337; 6,241,755; 6,228,107; 6,210,428;
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; 5,968;084; 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; 5,405,371; 5,350,417; 5,336,250;
5,324,320; 5,300,102; 5,300,101; 5,184,612; 5,044,364; 4,572,188. Japan
2,561,326. Canada 1,325,484. EPO 0,311,336. Australia 756,900.
Other patents pending.

201031A 04/04

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©2003-2004 Arizant Healthcare Inc. All rights reserved.
10393 West 70th Street, Eden Prairie, MN 55344 USA
TEL [phone] • 952-947-1200 • FAX [phone] • 952-947-1400
www.arizanthealthcare.com