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Schure Loc™ XPS

ProductID: 800-0280
  • Schure Loc™ XPS
  • Schure Loc™ XPS
  • Schure Loc™ XPS
  • Schure Loc™ XPS
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Increase operating room performance and productivity with the new SchureMed Schure Loc™ XPS portable arm and hand positioner. With no foot pedals, hoses, hydraulics or power cords around the operating room table, Schure Loc™ XPS combines strength and flexibility when intra-operatively adjusting the operative limb. Because the Schure Loc™ XPS maintains steady positioning from start-to-finish, the whole surgical team can focus on the open or arthroscopic limb procedure – no need to have the surgical aid hold the patient’s limb during the procedure! Great for beach chair or lateral position and now available– Schure Loc™ XPS accessories for elbow, wrist, knee or ankle surgery.

  • Single release lever releases all joints – locking in place when released
  • Easily attached to any OR table – ready for immediate use
  • Smooth, effortless positioning enhances operative site exposure
  • Decrease surgeon fatigue and improve OR team productivity
  • Convenient Schure Loc™ Shoulder Kit includes a sterile drape, foam hand/forearm holder and self-adherent wrap (purchase separately below)
  • 500 lb patient weight capacity

Required Accessory
Disp. Schure Loc™ XPS Sterile Kit

Optional Accessories
Schure Loc™ XPS Adapter
Schure Loc™ XPS Forearm Attachment
Schure Loc™ XPS Armboard
Schure Loc™ XPS Counter Traction Post
Schure Loc™ XPS TKR Positioner
Schure Loc™ XPS TKR Sterile Boot Liners
Schure Loc™ XPS Elbow/Ankle Positioner

Copyright Notice
All rights reserved. Any duplication, adaption or translation without prior written consent is prohibited unless otherwise provided for in the relevant copyright laws.

Schure Loc™ XPS
800-0280
800-0280-EU
800-0280-UK
800-0280-DEN
800-0280-JPN 
800-0280-SWISS

Accessories (Sold Separately)
790-0039 Adaptor
790-0040 Forearm Attachment
790-0056 Armboard
790-0057 Counter Traction Post
790-0075 Elbow/Ankle Positioner
790-0077 TKR Positioner
800-0281 Disposable Sterile Kit
800-0146 TKR Disposable Sterile Boot Liners


Initial Release: 1/1/2013


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 Manufacturer
Emergo Europe Prinsessegracht 20, 2514 AP The Hague, The Netherlands

OVERVIEW OF COMPONENTS



1Schure 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 Sterile Boot Liner (Single use only) (800-0146)
5Schure Loc™ XPS Sterile Drape Kit (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)

GENERAL INFORMATION
  • This product not made with (NRL) Natural Rubber Latex
  • Device supports 227 kg proportional patient load (6'4" tall patient per 99% human body model)
  • Product warranty covers product from manufacturing defects for period of 2 years.
  • 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.
  • Product is maintenance free, check product condition before next use
  • Life of device is 5 years under normal use.
  • Storage device between –20°C to +30°C

Other products required for use:
800-0281 Disp. Schure Loc™ XPS Sterile Kit, 10 per case (not included)
The Disp. Schure Loc™ XPS Sterile Kit is required for the proper use of the Schure Loc™ XPS, and the Schure Loc™ XPS is only approved for use with it. The Disp. Schure Loc™ XPS Sterile Kit consists of a forearm pad, self-adherent wrap, and a sterile drape and is single use only. All products within the sterile kit are disposable.

800-0146 Sterile TKR Boot Liner, 12 per case (not included)
The Sterile TKR Boot Liner is required for the proper use of the Schure Loc™ XPS TKR and the Schure Loc™ XPS is only approved for use with it. The Sterile TKR Boot Liner consist of a pad and is single use only. The pad within the sterile kit are disposable.

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 when using the Schure Loc™ XPS.

PRODUCT USE WARNINGS

All of the products used may only be used in sterile condition, except the Articulating arm which is used with a sterile cover.  



The Adaptor, Forearm Attachment and TKR are supplied in a non-sterile condition and must be cleaned and sterilized before the first use. 


WARNING!

Risk of injury!
Hazard resulting from incorrect use. Be absolutely sure to follow the Instructions for use for your operating table system.


WARNING!

Risk of injury!
Vital functions can be impaired through incorrect positioning. Position the 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!
The maximum load placed on the product may not exceed the appropriate proportion of a patient weighing 227 kg. Restrictions result from the permissible overall load, among other things, of accessory rails when using operating tables with a low maximum load capacity. Be absolutely sure to follow the Instructions for use for your operating table system.


WARNING!
Risk of injury!
Collisions between accessories, the operating table, the table top and the patient can occur when adjusting or moving the operating table or table top or when transferring the table top. Observe the adjustment procedure and avoid collisions.


WARNING!
Risk of burning!
Patient to burn hazard due to contact with metal components in the device or accessories and/or if resting on wet drapes or electrically conductive padding. Avoid any contact between the patient and metallic components; never use moist or wet surgical drapes. Be absolutely sure to comply with the manufacturers operating instructions!


WARNING!
Risk of injury!
Before opening the swivel joints, hold the patients 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 the 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 the 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 the Articulating arm. It may lead to irreparable damage to the functioning of the unit.


WARNING!
Property damage!
Schure Loc™ XPS is used to support the 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 the product. Protect the 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 the product to large impacts and vibrations, the product is not designed for impulse loads.


WARNING!
Risk of infection!
Do not use the sterile set when the packaging of the sterile set is damaged.

ASSEMBLY
All of the products used, except the articulating arm, which is used with a sterile cover, may only be used in sterile condition.

Mounting PositionPosition for mounting/detaching the articulating arm

Neutral Position: Position articulating arm (as shown) when mounting the sterile cover

MOUNTING SCHURE LOC™ XPS ONTO SURGICAL TABLE  

The articulating arm must be in this position when attaching and detaching the unit from the surgical table rail. 

  

Mounting Articulating Arm to Table
  • Place the articulating arm in the mounting position
  • Verify the mounting knob is facing upward and in the loose unlocked position
  • Place clamp on accessory rail of surgical table in the seat plate area between the patient hip and knee
  • Tighten the clamp by turning the mounting knob to the right

You must clamp directly to the side rail to fix the articulating arm to the rail securely . 


Check to ensure the clamp is properly and safely tightened to prevent potential injury to patient or product damage.

MOUNTING THE ADAPTOR, ARMBOARD, COUNTER TRACTION POST, ELBOW/ANKLE POSITIONER, TKR AND FOREARM ATTACHMENT

Draping the Schure Loc™ XPS and mounting the Adaptor, Armboard, Counter Traction Post, Elbow/Ankle Positioner, TKR and Forearm Attachments

Position the Schure Loc™ XPS articulating arm in the neutral position when draping (See instructions for MOUNTING THE SCHURE LOC™ XPS ONTO THE SURGICAL TABLE)

  1. Tape the drape to the sterilized Schure Loc™ XPS Adaptor so that half the tape is on the drape and the remainder is on the adaptor as shown in (1) .
  2. Snap the Adaptor to the articulating arm as shown in (2). Twist to lock fully into place.
  3. Pull the drape down over the Adaptor and all the to the accessory rail to completely cover the Articulating Arm as shown in (3).
  4. Slip the end of the forearm attachment into the pocket at the bottom of the orearm Pad. Then slide the handle into the handle slot as shown in (4) and (5).
  5. Snap Schure Loc™ XPS Forearm attachment to the Adaptor, and rotate slightly to it is properly attached. See (6).
  6. Snap Schure Loc™ Armboard, Counter Traction Post. Elbow/Ankle Positioner and TKR, and rotate slightly to it is properly attached (see DISASSEMBLY).

SECURE PATIENT'S ARM



Placing and Securing the Patient's Arm
  1. Place patient arm into the Forearm Pad, ensuring the patient’s fingers wrap around the Forearm Attachment Handle and wrap the pad snugly around patient arm. See (1) and (2).
  2. Using the self-adherent wrap, secure patients arm to the forearm attachment by wrapping the entire assembly. Be sure to secure the hands and fingers with wrap. See (3) and (4).

Do not wrap the Adaptor in order to allow for intra-operative detachment. 

ADJUSTING ARTICULATING ARM

WARNING!
Risk of injury due to unintended movements downwards! 
When squeezing the trigger, the swivel joints are released and the SCHURE LOC™ XPS can be moved. Due to its own weight and the weight of the patient it will falls downwards. Before squeezing the trigger, firmly hold the SCHURE LOC™ XPS with both hands. After every adjustment process, ensure that the trigger is released and locks the SCHURE LOC™ XPS into place. Check that no foreign bodies (e.g. sterile cover, glove) are pinched. 


WARNING!
Excessive load may cause the mechanism to jam slightly. In this case, take the load off SCHURE LOC™ XPS, if necessary, detach the arm rest and push in the handle with increased force to open the joints.


Mount SCHURE LOC™ XPS in the seat plate area

  

Adjusting the Articulating Arm 

  1. Release the Schure Loc™ XPS upwards
  2. Squeeze the Trigger as far as it will go and hold it. All swivel joints are released, and the Schure Loc™ XPS can move freely.
  3. Swivel the articulating arm to the desired position
  4. Release the Trigger, and the swivel  joints of the Schure Loc™ XPS are locked
OTHER ACCESSORY INSTRUCTIONS
790-0056 Armboard
  1. Place patient’s arm  in the center of the pad, attach the strap to the Velcro®on the bottom of the armboard and wrap it around the arm and attach the strap to the Velcro® on the bottom of the board
790-0057 Counter Traction Post
  1. Articulate the Schure Loc™ XPS to the desire position, wrap the patient’s arm around the post with the elbow pointing up.
  2. Articulate the Schure Loc™ XPS to the desire position, rest the patient bottom foot on post
790-0075 Elbow/Ankle Positioner
  1. Articulate the Schure Loc™ XPS to the desire position, wrap the patient’s arm inside the cradle with the elbow pointing up
  2. Articulate the Schure Loc™ XPS to the desire position, rest the patient foot in the cradle
790-0077 TKR POSITIONER
  1. Drape the surgical table
  2. Articulate the Schure Loc™ XPS to the desire position, the TKR boot must be resting on the table
  3. Line the boot with our sterile Disposable Boot Liner #800-0146 (sold separately as a case of 12)
  4. Insert foot into the boot, secure the foot by wrapping sterile coban
DISASSEMBLY
During surgery you can check range of motion and maintain the sterile field by removing the forearm attachment, armboard, counter traction post, elbow/ankle positioner or TKR from the adaptor. Now their limbs can move independently without the Schure Loc™ XPS.



Removing the Adaptor, Forearm Attachment, Armboard, Counter Traction Post, Elbow/Ankle Positioner and TKR

  • To remove the Forearm Attachment, simultaneously press in both top release buttons (1) of the adaptor, and the Forearm Attachment will release upward
  • To remove the Armboard (3), Counter Traction post (4), Elbow/Ankle Positioner (5) or TKR (6) simultaneously press in both top release buttons (1) of the Adaptor, and the accessories will release upward
  • To remove the Adaptor, simultaneously press in both bottom release buttons (2) of the Adaptor, and the Adaptor will release from the articulating arm
DETACHING SCHURE LOC™ XPS FROM OPERATING TABLE

The articulating arm must be in this position when detaching the unit from the surgical table rail. 

  

Detaching Schure Loc™ XPS
!Place the  articulating arm in the mounting position.

  1. Loosen the clamp by turning the mounting knob to the left
  2. Move the articulating arm in an upward motion to remove from the accessory rail
  3. Remove product from accessory rail, clean and store
CLEANING AND DISINFECTION

WARNING!
The product must be cleaned and wipe or spray disinfected after every use. Clean and sterilize adaptor 790-0039, 790-0040 and 790-0077 before initial use and after every use.


WARNING!

Risk of infection!
Particles of grime may become encapsulated and lead to the product not reaching the desired germ-reduction after disinfection. Before disinfection, the product must be cleaned thoroughly of contamination and encapsulated particles of grime and then be dried.


WARNING!
Risk of infection!
Do not use the sterile set when the packaging of the sterile set is damaged.



WARNING!
Risk of infection!
If the articulating arm is used in areas with varying hygienic requirements, there is a risk of infection. Ensure that the articulating arm is always in the 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 the 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 the 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.

CLEANING AND DISINFECTION PROCEDURES
Components
Adaptor (790-0039)
Forearm (790-0040)
TKR (790-0077)

Cleaning
Ultrasonic bath (5 minutes, frequency 35 kHz) in low-alkaline detergent solution (e.g. Dr. Weigert MediClean 1% (v/v) in tap water*). Then, by using a soft nonmetallic brush (e.g. medium-hard toothbrush), the entire outer surface, especially the hardly accessible parts (metal parts) of the components are brushed under running tap water until no residues are visible (for at least 1 minute). All sliding surfaces, recesses and especially the central openings at the metal sides are flushed under running tap water for at least 45 seconds each side. During this process, move all movable parts. Use a disposable syringe (e.g. 60 ml) and 200 ml tap water* to rinse every flush-ing channel. Then rinse all accessible points with demineralized water for at least 10 seconds. Finally, dry all surfaces with a lint-free cloth.

Disinfection
Immerse in disinfection solution (30 minutes) (e.g. neodisher® SeptoMED, Dr. Weigert, 2% (v/v) at 20°C ± 2°C in tap water*). Before immersion use a disposable syringe (60 ml syringe) to rinse every flushing channel with 200 ml solution. To remove air bubbles move the components by hand in the solution for 10 seconds at the beginning of immersion. Finally, immerse components in cold, demineralized water (1 minute).

Sterilization 
Live steam temperature: 134°C; 3 x fractionated pre-vacuum; sterilization (at least 4 minutes). Or: Live steam temperature: 132°C; 3 x fractionated pre-vacuum; sterilization (at least 6.5 minutes)

Mechanical Cleaning and Disinfection Procedures 
Components:
Adaptor (790-0039)
Forearm (790-0040)
TKR (790-0077)

Cleaning
Connect  every flushing channel of the components with an injector. Rinse with cold tap water* (1 minute). Cleaning at 55°C (- 0°C, + 3°C, 5 minutes) with deter-gent, e.g. neodisher MediClean (0.5% V/V). Neutralization  with cold tap water* (2 minutes). Rinse with cold tap water* (1 minute)

Disinfection
Thermal disinfection at 93°C ( +5°C, - 0°C, 5 minutes) with demineralized water.

* Tap Water: minimum quality requirements: drinking water, temperature 30°C (+- 3°C)

DISPOSAL
  1. General - Prevent infection by cleaning and disinfecting product before disposal
  2. Packaging - Dispose packaging material via household waste according to national requirements
  3. Products - SchureMed will take back used product or no longer in service
  4. Disposable Product - Must be handled and disposed pursuant to national regulations

Available Combo Deals