Stryker Altrix Temperature Management Wraps Manuel D'utilisation page 2

English (EN)
Symbols
General warning
Refer to instruction manual/
booklet
Altrix controller
Do not puncture
CAUTION
US Federal Law restricts this device to sale by or on the order
ONLY
of a licensed physician.
Introduction
This manual assists you with the operation of your Stryker product. Read
this manual before operating this product. Set methods and procedures to
educate and train your staff on the safe operation of this product.
CAUTION
• Improper usage of the product can cause injury to the patient or
operator. Operate the product only as described in this manual.
• Do not modify the product or any components of the product. Modifying
the product can cause unpredictable operation resulting in injury to
patient or operator. Modifying the product also voids its warranty.
Note: Stryker continually seeks advancements in product design and
quality. This manual contains the most current product information
available at the time of printing. There may be minor discrepancies
between your product and this manual.
Product description
The Altrix® Temperature Management Wraps™ is a torso or thigh
wrap that you can use individually or in combination. The Colder style
connectors provide the means to connect to the Altrix Precision
Temperature Management System (referred to as the Altrix controller).
Indications for use, Contraindications, Clinical benefits, and
Environmental conditions
Always consult the Altrix Precision Temperature Management System
Operations Manual before you apply the wrap.
Expected life
Each Altrix Temperature Management Wraps has a 14 day single
patient use expected life under normal use conditions.
Disposal/recycle
Always follow the current local recommendations and/or regulations
governing environmental protection and the risks
associated with recycling or disposing of the equipment at the end of its
useful life.
Material
Polyurethane (ether-based), Polyester Polyurethane Foam, Non-Woven
Spun-Bonded Polyester Fabric (patient side)
2
Caution
Consult instructions for
use
Single patient use
Single patient use
1
MR conditional under the
following conditions:
MR
3T static magnetic field
Catalogue number
CE mark
Manufacturer
European medical
device
Use-by date
Contact information
If you have any questions, contact Stryker Customer Service or Technical
Support at 1-800-327-0770.
Note - The user and/or the patient should report any serious product-
related incident to both the manufacturer and the Competent authority of
the European Member State where the user and/or patient is established.
To view your product manual online, see https://techweb.stryker.com.
Have the Lot batch code (A) available when you call Customer Service.
Include the Lot batch code in all written communication.
Small torso 26 in. - 47 in.
(66-119 cm)
Large torso 35 in. - 60 in.
(89-152 cm)
Small left thigh 16 in. - 28 in.
(41-71 cm)
Small right thigh
Large left thigh 19.5 in. - 32 in.
(50-81 cm)
Large right thigh
Small kits 8003-002-003
8003-003-001 x
8003-003-003 x
Large kits 8003-002-005
8003-003-002 x
8003-003-004 x
8003-009-005 REV E
Quantity
Authorized representative in the
European Community
Batch code
WARNING magnetic field
For US Patents see
www.stryker.com/patents
A
A
95-240 lb
(43-109 kg)
150-350 lb
(68-159 kg)
115-250 lb
(52-113 kg)
157-313 lb
(71-142 kg)
8003-002-004
x
x
8003-002-006
x
x
8003-002-001
8003-002-002
8003-002-003
8003-002-004
8003-002-005
8003-002-006
8003-002-001
x
n/a
8003-002-002
x
n/a