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Schure Loc™ XPS 800-0280
Accessories (sold separately)
790-0039 Schure Loc™ XPS Adaptor
790-0040 Schure Loc™ XPS Forearm Attachment
790-0056 Schure Loc™ XPS Armboard
790-0057 Schure Loc™ XPS Counter Traction Post
790-0075 Schure Loc™ XPS Elbow/Ankle Positioner
790-0077 Schure Loc™ XPS TKR Positioner
800-0146 Schure Loc™ TKR Boot Liners
800-0281 Schure Loc™ XPS Sterile Kit
INTENDED USE
Schure Loc™ XPS is used to hold a patients extremity securely during surgical procedures. Schure Loc™ XPS is mounted to an accessory rail of a surgical table and has a full range of motion which can be locked in various positions using one hand trigger. You can intra-operatively adjust the patient’s limb while maintaining the sterile field. The intended users of this device are medical professionals within hospitals and surgery centers.
COMPONENT OVERVIEW
1—Schure Loc™ XPS Articulating Arm
Accessories Sold Separately
2—Schure Loc™ XPS Adaptor (790-0039)
3—Schure Loc™ XPS Forearm Attachment (790-0040)
4—Schure Loc™ XPS TKR Boot Liners (Disposable-Single use only) (800-0146)
5—Schure Loc™ XPS Sterile Kit (Disposable-Single use only) (800-0281)
—Sterile Forearm Pad
—Sterile Self-Adherent Coban Wrap
—Sterile Drape
6—Schure Loc™ XPS TKR Positioner (790-0077)
7—Schure Loc™ XPS Counter Traction Post (790-0057)
8—Schure Loc™ XPS Armboard (790-0056)
9—Schure Loc™ XPS Elbow/Ankle Positioner (790-0075)
Schure Loc™ XPS is used to hold a patient’s extremity securely during surgical procedures.
Schure Loc XPS attaches to any side rails that are within the following dimensions:
Rail Width Size: .23” - .39” (6 mm - 10 mm)
Rail Height Size: .98” - 1.49” (25 mm - 38 mm)
GENERAL INFORMATION
- Product not made with (NRL) Natural Rubber Latex
- Device supports 500 lb. (227 kg) proportional patient load (6'4" (193 cm) tall patient per 99% human body model)
- Product warranty covers product from manufacturing defects for period of 2 years (Excluding Disposable 800-0281 and 800-0146)
- If damaged in shipping, call Customer Service at (888) 724-8763 to obtain Return Material Authorization (RMA) 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.
- Storage device between –4°F to +86°F (-20°C to 30°C)
GENERAL SPECIFICATIONS
- Maximum Length: 38” +/- 0.5” (97 cm +/- 1 cm)
- Maximum Reach: 40.5” +/- 0.5” (103 cm +/- 1 cm)
- Minimum distance from side/rail: 6.5” +/- 0.5” (17 cm +/- 1 cm)
- Net Weight, Arm Only: 12.4 +/- 0.5 lbs. (5.6 +/- .22 kg)
- Net Weight with Adapter and Forearm Attachment: 14.3 +/- 0.5 lbs. (6.5 +/- .22 kg)
- Gross Weight: 21 +/- 0.5 lbs. (9.5 +/- .22 kg)
Other products required for use:
800-0281 Schure Loc™ XPS Sterile Kit, 10 per case (not included)
Schure Loc™ XPS Sterile Kit (forearm pad, self-adherent wrap and sterile drape) is strictly required for proper use of the Schure Loc™ XPS. All products within sterile kit are disposable and single-use only.
800-0146 Schure Loc™ XPS TKR Boot Liners, 12 per case (not included)
TKR Boot Liners are strictly required for proper use of Schure Loc™ XPS. Liner Pad, within sterile kit, is disposable and single-use only.
PRODUCT USE WARNINGS
WARNING! All products used may only be used in sterile condition, except Articulating arm which is used with a sterile cover.
WARNING! Adaptor, Forearm Attachment and TKR are supplied in a non-sterile condition and must be clean and sterilized before first use.
WARNING!
Risk of injury!
Hazard resulting from incorrect use. Be absolutely sure to follow Instructions for Use for your operating table system.
WARNING!
Do not reuse device if there are obvious signs of damage or functional issues. Consult manufacturer before reusing.
WARNING!
Risk of injury!
Vital functions can be impaired through incorrect positioning. Position patient correctly and maintain continuous observation.
WARNING!
Risk of injury!
A worn or damaged product/accessory can cause injuries. Only use products/accessories which are in perfect condition.
WARNING!
Risk of injury!
Maximum load should not exceed appropriate proportion of a patient weighing 500 lbs. (227 kg). Use care with low-maximum load capacity surgical tables that accessory rails are not overloaded. Strictly follow Instructions for Use for your Operating Table system.
WARNING!
Risk of injury!
Collisions between accessories, operating table, table top and patient can occur when adjusting or moving operating table or table top or when transferring table top. Observe adjustment procedure and avoid collisions.
WARNING!
Risk of burning!
Patient to burn hazard due to contact with metal components in device or accessories and/or if resting on wet drapes or electrically conductive padding. Avoid any contact between patient and metallic components; never use moist or wet surgical drapes. Be absolutely sure to comply with manufacturers operating instructions!
WARNING!
Risk of injury!
Before opening swivel joints, hold patient's limb securely. Make sure that all swivel joints are closed after each adjustment procedure.
WARNING!
Risk of injury!
Whenever the product is mounted and adjusted, there is a WARNING of pinching and shearing to staff, patient and accessories. Always ensure that no one can be subjected to pinching or shearing action or injured in any other way and that the accessories do not collide with any nearby objects.
WARNING!
Risk of injury!
Patient may be endangered as a result of incorrect use. Follow operating instructions for all accessories.
WARNING!
Risk of mobile operating table tipping over!
The product affects the center of gravity of the mobile operating table. When positioning the patient, be absolutely sure to follow the Instructions for Use for your operating table system.
WARNING!
Property damage!
Do not lubricate or oil Articulating arm. It may lead to irreparable damage to the functioning of unit.
WARNING!
Property damage!
Schure Loc™ XPS is used to support arm of the patient. No other additional forces, may act on Schure Loc™ XPS .
WARNING!
Property damage!
During surgery, Schure Loc™ XPS must be covered by a sterile cover to protect it against from liquids.
WARNING!
Property damage!
High temperatures, moisture and humidity can damage product. Protect product against moisture and humidity, clean by wipe disinfection only. Do not store close to radiators and protect from high solar radiation. Do not expose product to large impacts and vibrations, product is not designed for impulse loads.
WARNING!
Risk of infection!
Do not use sterile set when packaging of sterile set is damaged.
ASSEMBLY
All products used, except articulating arm, which is used with a sterile cover, may only be used in sterile condition.
Mounting Position: Position for mounting/detaching articulating arm
Neutral Position: Position articulating arm (as shown) when mounting sterile cover
MOUNTING SCHURE LOC™ XPS ONTO SURGICAL TABLE
Articulating arm must be in mounting position when attaching and detaching unit from surgical table rail.
Mounting Articulating Arm to Table
- Place articulating arm in mounting position
- Verify mounting knob is facing upward and in loose unlocked position
- Place clamp on accessory rail of surgical table in seat plate area between patient hip and knee
- Tighten clamp by turning mounting knob to the right
You must clamp directly to side rail to fix articulating arm to rail securely .
Check to ensure the clamp is properly and safely tightened to prevent potential injury to patient or product damage.
Draping Schure Loc™ XPS and Mounting Adaptor, Armboard, Counter Traction Post, Elbow/Ankle Positioner, TKR and Forearm Attachments
! Position Schure Loc™ XPS articulating arm in the neutral position when draping (See instructions for MOUNTING SCHURE LOC™ XPS ONTO SURGICAL TABLE)
- Tape drape to sterilized Schure Loc™ XPS Adaptor so that half the tape is on drape and remainder is on adaptor as shown in (1) .
- Attach Adaptor to articulating arm as shown in (2). Twist to lock fully into place.
- Pull drape down over Adaptor and to accessory rail to completely cover Articulating Arm as shown in (3).
- Slip end of forearm attachment into pocket at bottom of Forearm Pad. Then slide handle into handle slot as shown in (4) and (5).
- Attach Schure Loc™ XPS Forearm attachment to Adaptor, and rotate slightly so it is properly attached. See (6).
- Attach Schure Loc™ Armboard, Counter Traction Post. Elbow/Ankle Positioner and TKR, and rotate slightly so it is properly attached (see DISASSEMBLY).
SECURE PATIENT'S ARM
Placing and Securing Patient's Arm
- Place patient arm into Forearm Pad, ensuring patient’s fingers wrap around Forearm Attachment Handle and wrap pad snugly around patient arm. See (1) and (2).
- Using self-adherent wrap, secure patients arm to forearm attachment by wrapping entire assembly. Be sure to secure hands and fingers with wrap. See (3) and (4).
Do not wrap Adaptor in order to allow for intra-operative detachment.
ADJUSTING ARTICULATING ARM
WARNING!
Risk of injury due to unintended movements downwards!
When squeezing trigger, swivel joints are released and SCHURE LOC™ XPS can be moved. Due to its own weight and weight of patient it will falls downwards. Before squeezing trigger, firmly hold SCHURE LOC™ XPS with both hands. After every adjustment process, ensure that trigger is released and locks SCHURE LOC™ XPS into place. Check that no foreign bodies (e.g. sterile cover, glove) are pinched.
WARNING!
Excessive load may cause mechanism to jam slightly. In this case, take load off SCHURE LOC™ XPS, if necessary, detach arm rest and push in handle with increased force to open the joints.
Mount SCHURE LOC™ XPS in seat plate area
Adjusting the Articulating Arm
- Release Schure Loc™ XPS upwards
- Squeeze Trigger as far as it will go and hold it. All swivel joints are released, and Schure Loc™ XPS can move freely.
- Swivel articulating arm to desired position
- Release Trigger and Schure Loc™ XPS swivel joints will be locked
OTHER ACCESSORY INSTRUCTIONS
790-0056 Schure Loc™ XPS Armboard
- Place patient’s arm in center of pad, attach strap to velcro on bottom of armboard and wrap it around arm and attach strap to velcro on bottom of board
790-0057 Schure Loc™ XPS Counter Traction Post
- Articulate Schure Loc™ XPS to desired position, wrap patient’s arm around post with elbow pointing up.
- Articulate Schure Loc™ XPS to desired position, rest patient bottom foot on post
790-0075 Schure Loc™ XPS Elbow/Ankle Positioner
- Articulate Schure Loc™ XPS to desired position, wrap patient’s arm inside cradle with elbow pointing up
- Articulate Schure Loc™ XPS to desired position, rest patient foot in cradle
790-0077 Schure Loc™ XPS TKR POSITIONER
- Drape surgical table
- Articulate Schure Loc™ XPS to desired position, the TKR boot must be resting on the table
- Line boot with our sterile Disposable Boot Liner #800-0146 (sold separately as a case of 12)
- Insert foot into boot, secure foot by wrapping sterile coban
DISASSEMBLY
During surgery you can check range of motion and maintain sterile field by removing forearm attachment, armboard, counter traction post, elbow/ankle positioner or TKR from adaptor. Now their limbs can move independently without Schure Loc™ XPS.
Removing Adaptor, Forearm Attachment, Armboard, Counter Traction Post, Elbow/Ankle Positioner and TKR
- To remove Forearm Attachment, simultaneously press in both top release buttons (1) of adaptor, and Forearm Attachment will release upward
- To remove Armboard (3), Counter Traction post (4), Elbow/Ankle Positioner (5) or TKR (6) simultaneously press in both top release buttons (1) of Adaptor, and accessories will release upward
- To remove Adaptor, simultaneously press in both bottom release buttons (2) of Adaptor, and Adaptor will release from articulating arm
DETACHING SCHURE LOC™ XPS FROM OPERATING TABLE
Articulating arm must be in mounting position when detaching unit from surgical table rail.
Detaching Schure Loc™ XPS
!Place articulating arm in mounting position (as shown in example on the left).
- Loosen clamp by turning mounting knob to the left
- Move articulating arm in an upward motion to remove from accessory rail
- Remove product from accessory rail, clean and store
CLEANING AND DISINFECTION
WARNING!
Product must be cleaned and wipe or spray disinfected after every use.
WARNING!
Clean and sterilize Adaptor 790-0039, Forearm Attachment 790-0040 and TKR Positioner 790-0077 before initial use and after every use.
WARNING!
Do not submerge or use washer cleaning for the Schure Loc XPS 800-0280 or Traction Post 790-0057 or Armboard 790-0056 or Elbow/Ankle Positioner 790-0075.
WARNING!
Risk of infection!
Particles of grime may become encapsulated and lead to product not reaching desired germ-reduction after disinfection. Before disinfection, product must be cleaned thoroughly of contamination and encapsulated particles of grime and then be dried.
WARNING!
Risk of infection!
Do not use sterile set when packaging of sterile set is damaged.
WARNING!
Risk of infection!
If articulating arm is used in areas with varying hygienic requirements, there is a risk of infection. Ensure that articulating arm is always in sterile area while being used.
WARNING!
Improper cleaning and disinfection can cause property damage!
Perform visual and functional inspections after each cleaning and disinfection process.
WARNING!
Improper cleaning and disinfection can cause property damage!
Do not use following products for cleaning and disinfection:
- Products containing alcohol
- Halogenides
- Dehalogenating compound
- Products that may scratch the surface
- Water containing iron particles
- Cleaning sponges containing Iron
- Products containing hydrochloric acid
Use approved detergents and disinfectants only. Use a soft, lint free cloth or a soft nylon brush to clean product.
CAUTION!
Improper cleaning and disinfection can cause property damage!
Use only as much detergent and disinfectant as required. Thoroughly wipe off any excess detergent and disinfectant with a damp, soft cloth. Avoid surface drying of excess detergent and disinfectants.
HAND AND WASHER MACHINE CLEANING INSTRUCTIONS
- Clean Schure Loc™ XPS System thoroughly before each use by either hand or washer cleaning
- Recommended cleaning products: (All solutions should be used in accordance with manufacturer’s instructions)
- Enzymatic neutral pH detergent solution
- (Enzymatic cleaners are compatible with metal devices/instruments and are preferred)
- Non-enzyme, hydrogen peroxide based solution
- Coverage Plus NPD One Step Cleaner, Disinfectant & Deodorizer Concentrate
- Disassemble Schure Loc™ XPS System in to separate parts for cleaning
Hand Cleaning
- Can be used for all Schure Loc XPS components
- Scrub each piece with a soft, plastic scrub brush and a recommended cleaning solution (see above)
- Rinse all parts thoroughly to remove any chemical residue
- Wipe each part completely dry with a clean, lint-free cloth
Washer Cleaning
- Can only be used for Adaptor 790-0039, Forearm Attachment 790-0040 and TKR Positioner 790-0077
- Put through washer/decontaminator according to manufacturer’s instruction (Select cycle that does not included lubrication)
- Prepare for sterilization (device must be cleaned before sterilization)
- See sterilization instructions below
*Based on information provided by the Healthcare Infection Control Practices Advisory Committee (HICPAC), the Center for Disease Control (CDC), the National Center for Biotechnology Information (NCBI) and the U.S. National Library of Medicine.
STEAM STERILIZATION
Use only for Adaptor 790-0039, Forearm Attachment 790-0040 and TKR Positioner 790-0077. Wrap using envelope method or accepted wrap method at your facility.
Pre-Vacuum
Wrapped Instruments
Set Temperature at 132°C (270°F)
Full Cycle Time: 6.5 minutes
Dry Time: 40 minutes
DISPOSAL
- General - Prevent infection by cleaning and disinfecting product before disposal
- Packaging - Dispose packaging material via household waste according to national requirements
- Products - SchureMed will take back used product or no longer in service
- Disposable Product - Must be handled and disposed pursuant to national regulations
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.
IFU-800-0280 REV 3.11
Basic UDI-DI: 081005737F0036L2
Latest Revision: 2022-01
eIFU Language Versions
To download and print the Instructions for Use, please click here.
Symbol Glossary
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