SchureMed 800-0074-SF User manual

IFU-800-0074-SF REV 3.06
Latest Revision: 2022-01
1
Instructions for Use
Schure Spine Frame Dolly 800-0074-SF
INTENDED USE
Intended use is to store components of our Schure
Spine Frame. 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
[phone] or [phone] to obtain Return
Material Authorization number. For product
warranty issues, contact Customer Service.
•CE marked medical device according to MDR (EU)
2017/745
•Product is maintenance-free, check product
condition before next use
•Life of device is 5 years under normal use
•Store device between -4°F to +86°F (-20°C to 30°C)
GENERAL SPECIFICATIONS
Device Dimensions (maximum)
•Length: 27” +/- 0.5” (69 cm +/- 1 cm)
•Width: 12” +/- 0.5” (31 cm +/- 1 cm)
•Height: 39” +/- 0.5” (99 cm +/- 1 cm)
•Device Weight: 28 +/- 0.5 lbs. (12.7 +/- .22 kg)
•Fully Assembled
COMPONENT OVERVIEW
Schure Spine Frame Dolly is a storage cart used to store components of our Schure Spine Frame.
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

IFU-800-0074-SF REV 3.06
Latest Revision: 2022-01
2
INSTRUCTIONS
1
2
3
Step 1. When placing Spine Frame onto Dolly, have buttons facing up and close together as shown.
Step 2. Place Spine Frame onto Dolly (as shown) and slide all the way back until plastic of frame aligns
with back of Dolly blocks.
Step 3. Loop hook and loop fastener straps around Dolly and fasten them onto frame.
PRODUCT USE WARNINGS
WARNING!
Hazard resulting from incorrect use. Be absolutely sure to follow Instructions for Use for when operating
Dolly.
WARNING! Do not reuse device if there are obvious signs of damage or functional issues. Consult
manufacturer before reusing.
CLEANING & DISINFECTING
Spray and wipe clean with hospital approved disinfectant. No sterilization.
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.
Basic UDI-DI: 081001460F0006DU
eIFU Language Versions
To download and print the Instructions for Use, please go to http://www.schuremed.com/schuremed-eifu.

IFU-800-0074-SF REV 3.06
Latest Revision: 2022-01
3
Symbol Glossary
Symbol
Title
Symbol Description
Manufacturer
Indicates the medical device manufacturer.
Authorized Representative in
the European Community
Indicates the authorized representative in the european community.
Use-by Date
Indicates the date after which the medical device is not to be used.
Batch Code
Indicates the manufacturer's batch code so that the batch or lot can be identified.
Catalogue or Item Number
Indicates the manufacturer's catalogue or item number so that the medical device can be identified.
Serial Number
Indicates the manufacturer's serial number so that a specific medical device can be identified.
Caution
To indicate that caution is necessary when operating the device or control close to where the
symbol is placed, or to indicate that the current situation needs operator awareness or operator
action in order to avoid undesirable consequences.
Medical Device
Indicates the item is a medical device.
Unique Device Identifier
Indicates a barcode as containing unique device identifier information.
CE Marking
European Conformity.
Single Patient Use
Indicates the item is a single patient use medical device.
Manufacturer
SchureMed (081001460)
452 Randolph Street, Abington, MA 02351 USA
Toll Free [phone] | Ph [phone] | Fax [phone] | [e-mail]
Authorized Representative
Emergo Europe, Prinsessegracht 20, 2514 AP The Hague, The Netherlands