Game ready ATX BACK WRAP, Руководство пользователя

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GENERAL
IMPORTANT
DO NOT SET THE GAME READY SYSTEM OR MED4 ELITE SYSTEM TO HIGH
PRESSURE WHEN USING THE BACK WRAP.
READ THIS COMPLETE USE GUIDE AND GAME READY GRPRO 2.1 SYSTEM USER
MANUAL AND/OR MED4 ELITE SYSTEM USER MANUAL INCLUDING INDICATIONS,
CONTRAINDICATIONS, CAUTIONS AND WARNINGS BEFORE USING THIS
PRODUCT!
WARNINGS
• Follow the recommendations of your health care practitioner regarding the
frequency and duration of use.
• Improper placement or prolonged use of the Game Ready System or Med4 Elite
System could result in tissue damage. During the course of therapy, patients
should monitor the skin surrounding the treated region or the digits of the
extremities of the treated limb for any burning, itching, increased swelling, or
pain. If any of these signs present, or any changes in skin appearance occur (such
as blisters, increased redness, discoloration, or other noticeable skin changes),
patients are advised to discontinue use and consult a physician.
• Game Ready Wraps are not sterile; do not place directly against open wounds,
sores, rashes, infections, or stitches. The Wrap may be applied over clothing or
dressing. A layer between Wrap and skin is recommended for all patients.
• Game Ready Wraps are available in multiple configurations but are not intended for
all possible physiologic uses. For example, the Ankle Wrap is not designed for use
on the toes and the Back Wrap is not designed for use in the abdominal region.
• To avoid potential damage to the Control Unit, do not use other manufacturers’
Wraps with the Control Unit.
• Use extra caution during the immediate postoperative period, especially when
sedated or on any medication that could alter normal pain sensation. Check the
skin of the treated region frequently and use mid-to-higher (warmer) temperature
range settings or leave more time between treatments, if necessary.
• Monitor the level of heat throughout treatment session. Caution should be
used with the Med4 Elite System or any thermotherapy (Heat Therapy) device
generating high intensity heat at 113°F or above. Check the skin of the treated
region frequently and use mid-to-lower (cooler) temperature range settings or
leave more time between treatments, if necessary.
• The Med4 Elite System is not intended for use with numbing agents.
• When using heat and rapid contrast therapy, skin should be protected in heat-
sensitive or high-risk patients, especially over regions with sensory deficits.
• Heating of the gonads should be avoided.
NOTES
Apply Wrap with a uniformly close fit, ensuring there are no kinks which may impede
water flow. Ensure connector hose is placed to prevent the Wrap from folding or
kinking at the hose inlet location of the Wrap.
CARE AND CLEANING
For daily care and to minimize formation of mildew, remove Heat Exchanger from
Sleeve and wipe with dry towel to remove any condensation that may form. Turn
Sleeve inside out and hang both the Sleeve and Heat Exchanger to release excess
moisture. For multi-patient use, if needed, use Sterifab
®
according to manufacturer’s
instructions to minimize microbe transfer.
For extended care, carefully remove the Heat Exchanger from the Sleeve and turn the
Sleeve inside out. Hand or machine wash the Sleeve in cold water and mild detergent,
or antibacterial soap. Hang to dry. Hand wash the Heat Exchanger with warm water
and mild detergent, do not machine wash or place in a dryer. Hang to dry.
AVERAGE LIFE EXPECTANCY
The life expectancy of Sleeves and Heat Exchangers will vary widely depending on
frequency of use. Please reference chart below to determine when to replace product.
Sleeve
Light Use (Personal) ............................................................ 12 months
Medium Use ....................................................................... 6 months
Heavy Use (Clinic or training facility) .................................. 3 months
Heat Exchanger
Light Use (Personal) ............................................................ 24 months
Medium Use ....................................................................... 18 months
Heavy Use (Clinic or training facility) .................................. 12 months
WARRANTY INFORMATION
Sleeve:
In case of manufacturer defect, Sleeve may be returned within 7 days of
purchase.
Heat Exchanger:
1 year from date of purchase. See warranty card included with
Heat Exchanger.
BEFORE INITIAL USE
Prime the Wrap using the following steps:
• With the GRPro 2.1 Control Unit
off, attach the Connector Hose to the
Control Unit and the Wrap
• Lay the Wrap open and flat next to
the Control Unit (not on the body)
• Turn the System on and run for 2
minutes with No Pressure
______________
• With the Med4 Elite Control Unit
off, attach the Connector Hose to
Patient 1 on Control Unit and the
Wrap
• Lay the Wrap open and flat next to
the Control Unit (not on the body)
• Press the On/Off button above the
touchscreen
• Choose Patient 1 and run Cold
Therapy with No Pressure for 2
minutes
1
Put the Back Wrap on by first placing it
behind the body, wrapping the sides around
the waist toward the front as shown above.
2
Ensure that the Back Wrap has been applied
uniformly against the lower back with a close
and snug fit.
3
Attach the Wrap to the Control Unit with the
Connector Hose. There should be an audible
“click”. To disconnect, simply press the blue or gray
button and remove the connector from the Wrap.
BACK WRAP APPLICATION
SUPERSEDED