Pacey Cuff Ultra User manual

INDICATIONS FOR USE
The Pacey Cuff Ultra is indicated for provision of male
urinary continence. The device is used during waking
hours as required. A light pad is recommended for use
with the device.
COMPONENTS
Pacey Cuff - Urethral control device designed to stop
leaks without restricting circulation.
1
2. Position Pacey Cuff
• Squeeze the top and bottom
pieces together, around the
penis, with your dominant
hand to obtain necessary
compression to stop the flow
of urine.
Important: Do not use the
strap guide to compress the
Pacey Cuff.
Strap
Urethra
Fenestrated Hood
3. Secure Pacey Cuff
• Secure the remaining strap.
• Ensure top hood and bottom
pressure pad are centered
on the penis. Inspect and
prevent any skin pinching that
may have occurred between
upper and lower parts.
SLIDE STRAP
TO ADJUST
If leaking persists:
ADJUSTABLE
Bottom
In addition to the top strap,
the bottom piece can be
adjusted to the left or right
to adjust the overall fit.
If leaking occurs after first
application:
1. The bottom strap setting
should arrive set at around 3.
2. Slide the bottom strap to a
higher setting (3.5–4).
1. Attach the Power Sleeve
• Wrap the Power Sleeve mid-
shaft around the penis before
applying the Cuff.
• Attach the ends together.
The sleeve should be snug.
• The ends should be attached
on the side of the penis. If
there is discomfort, re-apply
less tightly.
• Apply the Pacey Cuff over top
of the Power Sleeve
Top
Adjustable
Bottom
Strap
Urethral Pressure
Pad with
anti-pinch
Enhanced
anti-pinch tab
2
Power Sleeve - Designed for use with the Pacey Cuff
urethral control device.
Velcro patch
INSTRUCTIONS FOR USE
Important: Compression and
tightening the Velcro® strap
may need to be attempted a
few times to determine the
correct pressure.
Important: Do not over-stretch the Power Sleeve.
3
4
P

Symbol Definition
Manufacturer
Authorized representative in the European Community
Consult instructions for use
Batch code
CE Mark
Product code
MR Unsafe (Power Sleeve only)
Warnings
REF
Pacey MedTech Ltd.
203 - 1099 West 8th Avenue
Vancouver, BC Canada V6H 1C3
Telephone : [phone]
[e-mail] | paceycuff.com
All patents pending. Pacey Cuff™ is a registered trademark of Pacey Medtech Ltd.
©2020
Doc: LBL-023 Rev B
Medical Device Safety Service GmbH
Schiffgraben 41
30175 Hannover, Germany
Recommended:
• Use brief-style, form-fitting undergarments rather than
looser boxer shorts.
• Petroleum gel may be used to protect the skin from
possible irritation.
• The device may be worn during exercise and swimming.
Cleaning:
Wash the Pacey Cuff Ultra and the Power Sleeve in
warm water. A mild soap free of any hydrating agents,
perfumes, deodorants, preservatives, detergents
or coloring may be used. Do not tumble dry.
Voiding:
• The Power Sleeve does not need to be removed during
urination. When voiding, simply loosen the Pacey Cuff,
and re-tighten the Cuff once the bladder is empty.
• Void every 1-2 hours and exercise light fluid intake.
Product life cycle:
Pacey Medtech recommends that the device be replaced
as required (approximately every 6 months).
Warnings:
• Remove the Pacey Cuff if pain, swelling, bleeding or
discomfort occurs.
• If patient has special needs, use the device with
professional supervision.
• Do not use the device if you are on medication that
impairs your ability.
• If skin becomes irritated, discontinue use until the
irritation resolves.
• Mechanical forces that twist or alter the Pacey Cuff
position may cause pain. If this occurs, remove the
Pacey Cuff and let blood supply return. If pain does
not subside, consult your medical professional.
• The Power Sleeve is not MR Compatible.
Consult a medical professional if the following
conditions are present:
• Conditions causing abnormal blood clotting. Conditions
that impair blood clotting and conditions that clot
blood such as coagulopathy. Increased blood clotting
may be congenital and/or acquired.
• Drugs that impair pain recognition (e.g. narcotics and
sleeping medication).
• Drugs that impair clotting and drugs that increase
clotting.
• Conditions such as sickle-cell disease that cause slow
blood flow and clot formation.
• For serious medical conditions please consult your
medical professional.
• For advanced peripheral or cardiac vascular disease
or diabetes mellitus, consult your physician or medical
professional prior to use.
• If you have a urinary tract infection (UTI), consult your
physician or medical professional before use.