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A-Line Positioner with Straps 800-0143
INTENDED USE
Intended use is to securely position the hand and forearm for a-line insertions. The intended users of this device are medical professionals within hospitals and surgery centers.
GENERAL INFORMATION
- Product not made with Natural Rubber Latex
- Product warranty covers product from manufacturing defects for period of 2 years
- If damaged in shipping, call Customer Service at (888) 724-8763 or (781) 982-7000 to obtain Return Material Authorization number. For product warranty issues, contact Customer Service.
- CE marked medical device according to MDR (EU) 2017/745
- Life of device is 5 years under normal use
- Store device between -4°F to +86°F (-20°C to 30°C)
COMPONENT OVERVIEW
Easy-to-use patient positioning device for all A-line insertions. Anatomically formed base with two, exclusive 1″W x 17″L (2 cm x 43 cm) soft-edge straps. Straps reduce risk of skin ulceration in patients. Base provides best angle for hand, wrist and forearm positioning. Keeps skin taut for optimal needle insertion. 12/cs.
INSTRUCTIONS
Become familiar with the features of patient positioning device before use with a patient. Always practice use on a nurse, physician or appropriate volunteer prior to using clinically.
- Place support under patient’s hand and forearm
- Attach one end of each strap across forearm and palm
- Secure free end of strap to hook on support underside
- Strap should be snug but not so tight to restrict circulation
- Incorporated slot in A-Line Positioner can be used to secure device to armboard
- To facilitate a-line insertion, wrist may be temporarily placed in hyper-extension by wrapping hand strap around thumb and attaching strap in position across palm
- Once insertion is completed, hand strap must be unwrapped from thumb and reattached to hook under support
GENERAL SPECIFICATIONS
Device Dimensions (maximum)
- Length: 10.5” +/- 0.5” (27 cm +/- 1 cm)
- Width: 3” +/- 0.5” (8 cm +/- 1 cm)
- Device Weight: .5 +/- 0.5 lbs. (.22 +/- .22 kg)
DISPOSAL
- General - Prevent infection by cleaning and disinfecting product before disposal
- Packaging - Dispose packaging material via household waste according to national requirements
- SchureMed accepts back used or retired products - or dispose of product in accordance with national requirements
PRODUCT USE WARNINGS
WARNING! Hazard resulting from incorrect use.
WARNING! Strap should be snug but not so tight to restrict circulation.
WARNING! Do not reuse device if there are obvious signs of damage or functional issues. Consult manufacturer before reusing.
USER NOTICE
Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.
SINGLE PATIENT USE – Please dispose after each use.
Basic UDI-DI: 081001560F0046ET
Latest Revision: 2022-01
eIFU Language Versions
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Manufacturer
SchureMed (081001460)
452 Randolph Street, Abington, MA 02351 USA
Toll Free ( 888 ) 724-8763 | Ph (781) 982-7000
Fax (781) 982-7001 | orders@schuremed.com
Authorized Representative
Emergo Europe, Prinsessegracht 20, 2514 AP The Hague, The Netherlands