SchureMed 800-0050 Multi Axis Arm Positioner Instructions

SchureMed 800-0050 Multi Axis Arm Positioner

Product Information

• The Multi-Axis Arm Positioner 800-0050 is a surgical table accessory designed to provide support for non-operative arms during surgical procedures. It is intended for use by medical professionals within hospitals and surgery centers. The device can be used in various positions such as seated, lateral, prone, neuro, and park bench positions.
• The unique pivoting design allows for infinite positioning.
• The device attaches to the surgical table rail with a clamp and comes with a replacement pad (508-0108 Multi-Axis Arm Positioner Concave Pad, 16 x 6 x 2) and requires Schure Socket XL (800-0134) which is sold separately. The device has a maximum load capacity of 500 lbs (227 kg).

Product Usage Instructions

Before using the Multi-Axis Arm Positioner with a patient, it is essential to become familiar with its features. Always practice use on a nurse, physician, or appropriate volunteer before using it clinically.

• Step 1: Attach the device to the surgical table rail with the clamp.
• Step 2: Insert the Schure Socket XL (800-0134) into the device.
• Step 3: Place the non-operative arm of the patient on the concave pad of the device.
• Step 4: Use the positioning handle to pivot and position the arm as required.

Cleaning and Disinfection Instructions

It is recommended to follow current Association of periOperative Registered Nurses Journal Guidelines for proper cleaning and disinfection procedures. Always adhere to standards for blood-borne pathogens from the Occupational Safety and Health Administration. Use recommended protective clothing, gloves, masks, and eye protection to clean the accessory.

• Step 1: Remove major contaminants from the accessory with disposable materials and follow appropriate bio-hazard waste disposal procedures.
• Step 2: Apply cleaning fluid liberally to the entire accessory and wipe with a clean, lint-free cloth until all moisture and cleaning fluid are removed from the accessory.
• Step 3: Let the accessory dry before using it again.

Note: Strictly read and follow the manufacturer’s directions for cleaning fluids. DO NOT use cleaners containing phenolics.
If there are obvious signs of damage or functional issues, do not reuse the device. Consult the manufacturer before reusing it. 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.

Instructions for Use

Multi-Axis Arm Positioner 800-0050

Replacement Pad
Multi-Axis Arm Positioner Concave Pad 508-0108

INTENDED USE
Multi-Axis Arm Positioner provides support for nonoperative arm during surgical procedures. The intended users of this device are medical professionals within hospitals and surgery centers.

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.

Set Up and Use of Multi-Axis Arm Positioner

• Attach Schure Socket XL P/N 800-0134 (sold separately) onto side rail
• Insert mounting post into Schure Socket XL
• Turn handle clockwise to loosely tighten Schure Socket XL
• Loosen Positioning Handle, move to desired position
• Adjust Schure Socket XL to position in lateral, prone, neuro and park bench positions
• Tighten and lock Positioning Handle and Schure Socket XL

Detaching Multi-Axis Arm Positioner from Surgical Table

• Turn clamp handle counterclockwise to loosen
• Remove from clamp

GENERAL SPECIFICATIONS

• Maximum Height: 21” +/- 0.5” (53 cm +/- 1 cm)
• Minimum Height: 7.5” +/- 0.5” (19 cm +/- 1 cm)
• Armboard Length: 16” +/- 0.5” (41 cm +/- 1 cm)
• Armboard Width: 6” +/- 0.5” (15 cm +/- 1 cm)
• Maximum Pad Depth: 2.25” +/- 0.5” (6 cm +/- 1 cm)
• Middle of Pad Depth: 1.5” +/- 0.5” (4 cm +/- 1 cm)
• Net weight: 5.1 lbs. +/- 0.5 lbs. (2.3 +/- .22 kg)
• Gross Weight: 8.2 lbs. +/- 0.5 lbs. (3.7 +/- .22 kg)
• Single-person installation

COMPONENT OVERVIEW

Multi-Axis Arm Positioner is a surgical table accessory providing support for non-operative arm during surgical procedures. Device attaches to surgical table rail with clamp, and used in seated, lateral, prone, neuro and park bench positions. Unique pivoting design allows for infinite positioning.

Replacement Pad

508-0108 Multi-Axis Arm Positioner Concave Pad, 16″ x 6″ x 2″ (41 cm x 15 cm x 5 cm)

Other required products for use: 800-0134 Schure Socket XL (sold separately)

• US: 0.374” x 1.122” (9.5 mm x 28.5 mm) PN# 800-0134
• Denyer: 0.236” x 1.496” (6 mm x 38 mm) PN# 800-0134-DEN
• Europe: 0.394” x 0.984” (10 mm x 25 mm ) PN# 800-0134-EU
• Eschmann (UK): 0.236” x 1.260” (6 mm x 32 mm) PN# 800-0134-UK
• Japan: 0.354” x 1.260” (9 mm x 32 mm ) PN# 800-0134-JPN
• Swiss: 0.394” x 1.181” (10 mm x 30 mm ) PN# 800-0134-SWISS

GENERAL INFORMATION

• Product not made with Natural Rubber Latex
• Device supports 500 lb. (227 kg) proportional patient load (6’4″ (193 cm) tall patient per 99% humanbody 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 ReturnMaterial 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)

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 nationalrequirements

PRODUCT USE WARNINGS

WARNING! 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.
WARNING! Hazards result from incorrect use. Strictly follow Instructions for Use with your Operating Table system.
WARNING! Do not reuse device if there are obvious signs of damage or functional issues. Consult manufacturer before reusing

CLEANING RECOMMENDATION

Follow current Association of periOperative Registered Nurses Journal Guidelines for proper cleaning and disinfection procedures

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

CAUTION
Strictly read/follow manufacturer’s directions for cleaning fluids. DO NOT use cleaners containing phenolics.

1. Remove major contaminants from accessory with disposable materials. Follow appropriate biohazard 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.
Basic UDI-DI: 081001460F0038E9

Symbol Glossary

Manufacturer
SchureMed ( 081001460)
Authorized Representative
Emergo Europe, Prinsessegracht 20, 2514 AP The Hague, The Netherlands

IFU-800-0050 REV 3.07
Latest Revision: 2022-01

References

• SchureMed Instructions for Use

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