2814 Posey Hand Control Mitt User Manual

Posey® Double Security Mitts
Application Instructions

DESCRIPTION OF PRODUCT : Padded mitts without fi nger separators. Connecting straps (for hospital bed use only).

Indications for Use

• Patients assessed to be at risk of disrupting life-saving treatments (e.g., chronic tube pulling).
• Patients assessed to be at risk of line pulling, which may prevent monitoring of vital signs.
• Patients whose picking, pulling, scratching, or peeling exacerbates a skin condition, causes self-injury, or compromises wound site integrity.

Contraindications

• DO NOT use on a patient who is or becomes highly aggressive, combative, agitated, or suicidal.
• NEVER use mitts on a patient:
  – If an IV or wound site could be compromised by the device; or
  – With a dislocation or fracture on the affected limb.
  See the Posey Catalog for other options for such a patient.

Adverse Reactions
Severe emotional, psychological, or physical problems may occur: if the applied device is uncomfortable; or if it severely limits movement. If symptoms of these problems ever appear for any reason, get help from a qualifi ed medical authority and fi nd a less restrictive product or intervention.

Application Instructions

(Repeat Steps 1-4 for each mitt):

1. Insert the patient’s hand into the mitt, palm down.

2. Wrap the wrist strap around the smallest part of the patient’s wrist, overthe top of the wrist, through the plastic ring, and secure it onto itself.

3.  Bring the second hook strap over the top of the loop strap to form a “double security” closure.

4.  Slide ONE finger (flat) between the device and the inside of the patient’s wrist to ensure proper fit. The strap must be snug, but not compromise circulation.
   Note: Follow steps 5-6 for use of optional mitt connecting strap (hospital bed use only) to help prevent the patient from removing the device or inflicting self-injury:

5. Wrap the strap around the patient’s wrist or pass it through the loops on the mitt.

6. Use Posey Quick-Release Tie (see drawings on reverse) to secure the end of the strap to a movable part of the bed frame. Tie strap at a point midway between the patient’s wrist and elbow, out of the patient’s reach.

WARNING ADDITIONAL OR DIFFERENT BODY OR LIMB RESTRAINTS MAY BE NEEDED (See Posey Catalog):

• If the patient pulls violently against the bed straps;
• To reduce the risk of the patient getting access to the line/wound/tube site;
• To prevent the patient from fl ailing or bucking up and down and causing self-injury.

Posey Finger Control Mitts
REF 2814 Double Security Mitts
REF 2819 Double Padded, Double Security Mitts
REF 2809 Mitt Connecting Strap

MONITOR PER FACILITY POLICY. Check to ensure that:

• Connecting straps cannot slide in any direction or loosen if the patient pulls on them, or if the bed is adjusted;
• Mitts and straps 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;
• Mitts are intact, not torn or damaged, and hook and loop closes securely. DO NOT allow patients to ingest mitt material;
• The patient cannot use his or her teeth or otherwise remove the device and infl ict self-injury;
• Monitor closely when the patient is out of bed. Patients who ambulate while wearing this device may be at risk of injury from a fall.

BED SAFETY

• ALWAYS use Hospital Bed Safety Workgroup (HBSW) (http://www.fda.gov search keyword “HBSW”) compliant side rails in the UP position and fi ll ALL gaps to reduce the risk of entrapment.
• Use side rail covers and gap protectors to help prevent the patient’s body from going under, around, through or between the side rails. A failure to do so may result in serious injury or death if a patient becomes suspended or entrapped. Posey offers a full range of side rail pads and/or gap protectors to cover gaps.

WARNING: ALWAYS Monitor patients per facility policy. Improper application or use of any restraint may result in serious injury or death.
RX ONLY. Federal law (USA) restricts this device to sale by or on order of a physician. For use in a licensed healthcare facility only.
STAFF TRAINING: Posey offers training aids at no charge. Contact Posey online at www.posey.com or call toll-free at 1.800.447.6739.

BEFORE APPLYING ANY RESTRAINT:
Follow your hospital’s restraint policies and procedures which are in compliance with CMS guidelines and state laws.

ADDITIONAL WARNINGS:

1. ALWAYS monitor patient per facility policy. Be aware that constant monitoring may be required for:
   • Aggressive or agitated patients; and
   • Patients in a supine positon; ensure that being in this position would not cause any complications for those who are at risk of vomiting while being restrained.

2. NEVER alter or repair this product. ALWAYS Inspect before each use: Check for broken stitches or parts; torn, cut or frayed material; or locks, buckles, or hook-and-loop fasteners that do not hold securely. DO NOT use soiled or damaged products. Doing so may result in serious injury or death. Dispose of damaged products per facility policy for BIOHAZARDOUS material.

3. ALWAYS secure straps to a part of the frame that moves with the patient (not foot/head board or siderails, out of the patients reach, using quick-release ties (see drawing below) or buckles. These allow easy release in the event of an accident or fire. Test to make sure straps cannot tighten, loosen, or slip and create excess slack. If this occurs, the patient may slide off the chair or bed, increasing the risk of serious injury or suffocation. Restraint release is an important part of facility fire and disaster drills.  traps
   can be cut with scissors in an emergency.

4. NEVER secure restraint strap to side rail or head/foot board.

5. NEVER use Posey products on toilets, or on any chair or furniture that does not allow proper application as directed in the Application Instructions. DO NOT use at home.

6.  NEVER expose this product to open flame, fire, smoking materials, or high heat sources. Some products may melt or ignite and burn. The facility smoking/no smoking policy should be strictly enforced.

7.  NEVER use a Posey product as a seat belt in a moving vehicle. Posey products are not designed to withstand the force of a crash or sudden stop.

8. Test Zippers or hook-and-loop fasteners before each use. DISCARD device if it does not fasten securely.

LAUNDERING INSTRUCTIONS (if applicable):

• Fasten all buckles and locks to reduce risk of damage during wash and dry cycles. DO NOT put buckles or locks through extractors. For maximum life, launder in a laundry bag.

• Before laundering, zip up and turn the product inside out to protect zipper.

• Hook-and-loop fasteners may collect lint after repeated use or laundering, reducing grip strength. Fasten the “hook” to the “loop” before laundering to help prevent lint buildup. As needed, use a stiff-bristle brush to remove lint from the “hook” side.

• These products, other than foam products, can be machine washed under CDC* guidelines for material soiled with blood orbodily fluid.

•  For non-contaminated material, use lower temperature wash and dry cycles to extend product life.

• For foam products:

BIOTHANE:

• Sanitize by submerging the entire product in 70% isopropyl alcohol for 10 minutes; or
• Apply an OSHA approved intermediate level disinfectant per manufacturer instructions. After cleaning, products MUST be rinsed with water to remove any residual chemicals.
• Make sure products are completely dry before use.
• Stainless Steel Locks: Posey recommends that locks be treated with a dryfilm lubricant (silicone) after each cleaning. For best results, spray a small amount into the lock. Work the action of the lock with a key several times to ensure that all the surfaces are well lubricated.

STORAGE AND HANDLING:

• This device is designed for use in normal indoor environments.
• This device may be stored in ambient warehouse temperatures at normal humidity levels. Avoid excess moisture or high humidity that may damage product materials.

*www.cdc.gov

HOW TO TIE THE POSEY QUICK-RELEASE TIE

1. Wrap the strap once around a movable part of the bed frame leaving at least an 8″ (20 cm) tail. Fold the loose end in half to create a loop and cross it over the other end.
2. Insert the folded strap where the straps cross over each other, as if tying a shoelace. Pull on the loop to tighten.
3. Fold the loose end in half to create a second loop.
4.  Insert the second loop into the first loop.
5.  Pull on the loop to tighten. Test to make sure strap is secure and will not slide in any direction.
6. Repeat on other side. Practice quick-release ties to ensure the knot releases with one pull on the loose end of the strap.

For RX PRODUCTS ONLY. Federal law (USA) restricts this device to sale by or on order of a physician. For use in a licensed healthcare facility only.
STAFF TRAINING: Tidi offers inservice training aids at no charge. Contact Tidi online at www.tidiproducts.com or call toll-free at 1.800.447.6739.
BEFORE APPLYING ANY RESTRAINT: Follow your hospital’s restraint policies and procedures which are in compliance with USA CMS guidelines and state laws or other governing agencies outside the USA.

ADDITIONAL WARNINGS:

1. ALWAYS monitor patient per facility policy. Improper application or use ofany restraint may result in serious injury or death. Be aware that constantmonitoring may be required for:
   • Aggressive or agitated patients; and
   • Patients in a supine positon; ensure that being in this position would not cause any complications for those who are at risk of vomiting whilebeing restrained.

2. NEVER alter or repair this product. ALWAYS Inspect before each use: Check for broken stitches or parts; torn, cut or frayed material; or locks, buckles, or hook-and-loop fasteners that do not hold securely. DO NOT use soiled or damaged products. Doing so may result in serious injury or death. Disposeof damaged products per facility policy for BIOHAZARDOUS material.

3. ALWAYS secure straps to a part of the frame that moves with the patient (not foot/head board or siderails), out of the patients reach, using quickrelease ties (see drawing below) or buckles These allow easy release in the event of an accident or fire. Test to make sure straps cannot tighten, loosen, or slip and create excess slack. If this occurs, the patient may slide off the chair or bed, increasing the risk of serious injury or suffocation. Restraint release is an important part of facility fire and disaster drills. Straps can be cut with scissors in an emergency.

4.  NEVER secure restraint strap to side rail or head/foot board.

5. NEVER use Posey products on toilets, or on any chair or furniture that does not allow proper application as directed in the Application Instructions. DO NOT use at home.

6. NEVER expose this product to open flame, fire, smoking materials, or high heat sources. Some products may melt or ignite and burn. The facility smoking/no smoking policy should be strictly enforced.

7. NEVER use a Posey product as a seat belt in a moving vehicle. Posey products are not designed to withstand the force of a crash or sudden stop.

8. Test Zippers or hook-and-loop fasteners before each use. DISCARD device if it does not fasten securely.

LAUNDERING INSTRUCTIONS (if applicable):

• Fasten all buckles and locks to reduce risk of damage during wash and dry cycles. DO NOT put buckles or locks through extractors. For maximum life, launder in a laundry bag.
• Stainless Steel Locks: Posey recommends that locks be treated with a dryfilm lubricant (silicone) after each cleaning. For best results, spray a small amount into the lock. Work the action of the lock with a key several times to ensure that all the surfaces are well lubricated.
• Before laundering, zip up and turn the product inside out to protect zipper.
• Hook-and-loop fasteners may collect lint after repeated use or laundering, reducing grip strength. Fasten the “hook” to the “loop” before laundering to help prevent lint buildup. As needed, use a stiff-bristle brush to remove lint from the “hook” side.

• These products, other than foam products, can be machine washed under CDC* guidelines for material soiled with blood or bodily fluid.

• For non-contaminated material, use lower temperature wash and dry cycles to extend product life.

• For foam products:

• Make sure products are completely dry before use.

STORAGE AND HANDLING:

• This device is designed for use in normal indoor environments.
• This device may be stored in ambient warehouse temperatures at normal humidity levels. Avoid excess moisture or high humidity that may damage product materials.

*www.cdc.gov

HOW TO TIE THE POSEY QUICK-RELEASE TIE

1. Wrap strap once around the frame that moves with the patient (do not attach to side rail or head/footboard), leaving at least an 8” (20 cm) tail.
   Fold the loose end in half to create a loop and cross it over the other end.

2. Insert the folded strap where the straps cross over each other, as if tying a shoelace. Pull on the loop to tighten.

3. Fold the loose end in half to create a second loop.

4. Insert the second loop into the first loop.

5. Pull on the loop to tighten. Test to make sure strap is secure and will not slide in any direction.

6. Repeat on other side. Practice quick-release ties to ensure the knot releases with one pull on the loose end of the strap.

Report any serious incident related to device use to TIDI Products and the Member State
Competent Authority. | Translations of this document in French, Spanish, Dutch, German,Italian, and Portuguese are located at www.tidiproducts.com/IFU.
DISPOSAL: Dispose of product according to facility guidelines or after thirty-day use or sooner if product is worn or damaged.
TIDI Products, LLC • 570 Enterprise Drive, Neenah, WI 54956 USA
Phone: 1.800.447.6739 • International: +1.920.751.4036 • www.tidiproducts.com
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany
**** UK Responsible Person Emergo Consulting (UK) Limited c/o Cr360 – UL International Compass House, Vision Park Histon Cambridge CB249BZ United Kingdom

References

• Centers for Disease Control and Prevention
• U.S. Food and Drug Administration
• Posey | First in Patient Safety
• Medical Products for Staff & Patient Safety | TIDI Products
• Medical Device and Supply Instructions for Use | TIDI Products

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