Posey 2816 Anwendungshinweise

Posey
Application Instructions
DESCRIPTION OF PRODUCT: Full padded, mesh mitt with finger separators.
INTENDED USE:
• To protect patients assessed to be at risk of disrupting life-saving treatments
(e.g., chronic tube pulling) or in danger of injury to themselves or to others by
limiting hand movement.
• Follow your hospital's restraint policies and procedures that are compliant
with USA CMS guidelines and state laws, or other governing agencies outside
the USA.
CONTRAINDICATIONS: None
APPLICATION INSTRUCTIONS: (Repeat steps 1-3 for each mitt)
NOTE: Product is designed for use with connecting strap (item 2809)
(visit tidiproducts.com).
1. Insert the patient's hand into the mitt, palm down. Separate the fingers so each
finger fits into its own slot.
2. Wrap the wrist strap around the smallest part of the patient's wrist, through the
fabric loop and then the plastic ring. Secure it with the hook-and-loop fastener.
3. Slide ONE finger (flat) between the mitt and the inside of the patient's wrist to
ensure proper fit. The strap must be snug, but not compromise circulation.
NOTE: Follow steps 4-5 for use of optional mitt connecting strap (hospital bed
use only) to help prevent the patient from removing the device or inflicting self-
injury:
4. Wrap the strap around the patient's wrist or pass it through the loops on
the mitt.
5. Use Posey Quick-Release Tie (see drawings on reverse) to secure the end of the
strap along the frame that moves with the patient out of patient's reach (do not
attach to side rail or head/footboard). Tie strap at a point midway between the
patient's wrist and elbow, out of the patient's reach.
PRECAUTIONS:
• A clinical assessment and decision are required when used with monitoring
lines or if patient has a wound or dislocated/fractured limb.
• Ensure that mitts are properly secured. If applied too tightly, circulation will be
restricted; if applied too loosely, the patient may be able to slip his or her limb
from the device.
CAUTION: RX Requirements.
Certain types of hand mitts can be considered a restraint. Pinning or otherwise
attaching those same mitts to bedding or using a wrist restraint in conjunction
with the hand mitts would meet the definition of restraint and the RX
requirements would apply. Refer to USA CMS Interpretive Guidelines 482.13(e).
Report any serious incident related to device use to TIDI Products and the Member
EN
State Competent Authority. | Translations of this document in French, Spanish, Dutch,
German, Italian, and Portuguese are located at www.tidiproducts.com/IFU.
TIDI Products, LLC • 570 Enterprise Drive, Neenah, WI 54956 USA
Phone: 1.800.521.1314 • International: +1.920.751.4036 • www.tidiproducts.com
© 2023 TIDI Products, LLC. All rights reserved. Posey is a registered trademark of TIDI Products, LLC.
Finger Control Mitt 2816
®
2816
POSEY FINGER CONTROL MITT:
Mesh Mitt with Finger Separators, Single Padded
2816
WARNING:
Additional or different body or limb restraints may be needed
(visit tidiproducts.com):
• Some patients may require additional interventions in conjunction with
this device in order to prevent injury to self or others.
– To reduce the risk of the patient getting access to the line/wound/
tube site.
• It is a clinical decision to decide when a restraint is no longer deemed safe.
BED SAFETY: Refer to the Food and Drug Administration (FDA) , or other
governing agencies outside the USA, for the most recent Hospital Bed Safety
Guidelines and the bed manufacturer's instructions for use.
ADDITIONAL SAFETY AND LAUNDERING INSTRUCTIONS ON OTHER SIDE.
MDSS GmbH
EC REP
Schiffgraben 41
30175 Hannover, Germany
MD
Rx ONLY
UK Responsible Person
Emergo Consulting (UK) Limited
c/o Cr360 – UL International
Compass House, Vision Park Histon
Cambridge CB249BZ
United Kingdom
I9292 REV D 2023-08-16