Pediatric E-Z Lift Stirrups

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Pediatric E-Z Lift Stirrups, KIDS   800-0342-KIDS

Pediatric E-Z Lift Stirrups, PUPS   800-0342-PUPS

Replacement Pads
KIDS Boot Pads   508-1296
PUPS Boot Pads   508-1295

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

Device Initial Release: 2/1/2014

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

INSTRUCTIONS FOR USE
All rights reserved. Any duplication, adaption or translation without prior written consent is prohibited unless otherwise provided in relevant copyright laws.

1. Attach SpringLoc Clamps P/N 800-0338 on accessory rails in same locations on opposite sides of surgical table at patient’s hip joints
2. Prior to placing device into SpringLoc Clamp, identify patient’s left and right side stirrup  indicated on boot label
   
   
3. Insert stirrup blade into clamp. Tighten clamp by turning handle to the right.
   
   
4. Ensure patient is positioned on surgical table in accordance with procedure and surgeon requirements
   WARNING!! To prevent patient or operator injury from inadvertent stirrup movement, securely tighten accessory clamp and boot clamp.
   
   
   (1 & 4) Free Floating Boot Pivot, (2) Boot Clamp, (3) Trigger Handle
   
   
5. Support patient’s leg by grasping heel in one hand and underside of knee with other hand. Gently flex knees and transfer leg into boot, then secure boot straps.
6. To achieve appropriate leg/foot position, loosen boot clamp. Adjust boot to desired position and re-tighten clamp. Ensure patient’s heels are securely seated in heels of boots.
7. To achieve appropriate lithotomy and abduction positions, squeeze trigger, adjust to desired position and release to lock.
   
   Note: Free-floating boot is designed to rotate about pivot shown above through-out the full range of motion, reducing risk of superficial nerve injury.

1. Loosen SpringLoc Clamp and remove stirrups by lifting out of clamps
2.  Remove accessory clamps from side rails

INTENDED USE
Pediatric E-Z Lift Stirrups are a patient positioning accessory used in Gynecology, Urology, and laparoscopic procedures. They provide a safe system for positioning the legs up to 160 lb. (73 kg) and 250 lb. (113 kg) patients in a variety of lithotomy/abduction positions.

• Height: 35” +/- 0.5” (89 cm +/- 1 cm)
• Width: 9” +/- 0.5” (23 cm +/- 1 cm)
• Depth: 14” +/-  0.5” (36 cm +/- 1 cm)
• Device Weight Per Stirrup: 8 +/-  0.5 lbs. (3.6 +/- .22 kg) (with pad)
• Range of Motion: -30° to 75° lithotomy range, -9° to 25° adduction to abduction
• Single-person installation
• Connects to seat section of surgical table
• Store stirrups on transport/storage dolly (P/N 800-0074-P sold separately)

COMPONENT OVERVIEW
Pediatric E-Z Lift Stirrups provide a safe system for positioning legs of up to 160 lbs. (73 kg) per patients for 800-0342-PUPS and 250 lbs. (113 kg) per patient for 800-0342-KIDS in a variety of lithotomy/abduction positions.

Other required products for use:
800-0338  SpringLoc Clamp
800-0338-EU  SpringLoc Clamp
800-0338-JPN  SpringLoc Clamp
800-0338-SWISS  SpringLoc Clamp

Replacement Pads
508-1295  PUPS Boot Pads
508-1296  KIDS Boot Pads

• Product not made with (NRL) Natural Rubber Latex
• This device supports a 160 lb. (73 kg) patient for 800-0342-PUPS and 250 lb. (113 kg) patient for 800-0342-KIDS proportional patient load (5'4" (163 cm) 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 or (781) 982-7000 to obtain Return Material Authorization (RMA) 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)

• 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!
Maximum load should not exceed appropriate proportion of a patient weighing 160 lbs. (73 kg) for 800-0342-PUPS and 250 lbs. (113 kg) for 800-0342-KIDS.  Use care with low-maximum load capacity surgical tables that accessory rails are not overloaded. Strictly follow instructions for your Operating Table system.

WARNING!
Hazard resulting from incorrect use. Strictly follow instructions for your Operating Table system.

WARNING!
Surgical table load capacities may be less. Never overload a surgical table. Device is intended for mounting on surgical table side rail only.

CLEANING RECOMMENDATION
Follow current Association of periOperative Registered Nurses (AORN) Journal Guidelines for proper cleaning and disinfection procedure.


WARNING!
Adhere to standards for blood-borne pathogens from the Occupational Safety and Health Administration (OSHA). Use recommended protective clothing, gloves, masks and eye protection to clean accessory.

1. Remove major contaminants from accessory with disposable materials. Follow appropriate bio-hazard waste disposal procedures.
2. Apply cleaning fluid liberally to entire accessory and wipe with clean, lint-free cloth until all moisture and cleaning fluid is removed from accessory
3. Let accessory dry

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-800-0342-PUPS-KIDS  REV 3.04

Basic UDI-DI: 081001460F0040DU

Latest Revision: 9/15/2021