C2Dx 8002-062-612 User manual

C2Dx, Inc. warrants that its models 8002-062-612, 8002-062-622, and
8002-062-626 Mul-T-Pad products will be free from defects in manufacturing
and workmanship for maximum of 30 day use period. “Use” period begins
requested by C2Dx, products of which a claim is made shall be returned
is authorized to change this warranty in any way.
Warranty exclusion and damage limita�ons
The express warranty set forth herein is the only warranty applicable to the
product. Any and all other warran�es, whether express or implied, including
any implied warranty of merchantability or fitness for a par�cular purpose
are expressly excluded by C2Dx.In no event shall C2Dx be liable for
incidental or consequential damages.
Return authoriza�on
Product cannot be returned without prior approval from the C2Dx Customer
Service Department. An authorization number will be provided which must be
printed on the returned product. C2Dx reserves the right to charge shipping
and restocking fees on returned product. Special, modied, or discontinued
products are not subject to return.
Damaged merchandise
ICC Regulations require that claims for damaged product must be made with
within fteen (15) days of receipt of the product. Do not accept damaged
shipments unless such damage is noted on the delivery receipt at the time
of receipt. Upon prompt notication, C2Dx will le a freight claim with the
appropriate carrier for damages incurred. Claims will be limited in amount to
the actual replacement cost. In the event that this information is not received by
C2Dx within the fteen (15) day period following the delivery of the product,
or the damage was not noted on the delivery receipt at the time of receipt, the
customer will be responsible for payment of the original invoice in full within
thirty (30) days of receipt. Claims for any incomplete shipments must be made
within thirty (30) days of invoice.
Interna�onal warranty clause
This warranty reects U.S. domestic policy. Warranty outside the U.S. may
vary by country. Please contact your local C2Dx Inc. representative for extra
information.
General warning Caution
Consult instructions for
use Do not puncture
Quantity 1Single patient use
Batch code Catalogue number
Date of manufacturer Manufacturer
Symbols
Opera�ons Manual
2022/08 8002-009-131 REV 2 www.C2Dx.com
Warranty
2022/08 8002-009-131 REV 2 www.C2Dx.com
Manufactured For:
C2Dx Inc.
555 E. Eliza St. | Ste. A
Schoolcraft, MI 49087 USA
Opera�on
Mul-T-Pad
8002-062-612
8002-062-622
8002-062-626
WARNING
• Do not use if the package is damaged.
• Always use Mul-T-Pad products with an approved temperature controller.
Using this product with other controllers has not been tested.
• Do not reuse this product on another pant to avoid the risk of cross-
contaminainf
• Do not use this product to por transfer a pant.
• Do not allow hoses to fold, kink, or to wrap around a pant.
• Always pre-ll the pad before applying to the pant.
• Always check the pant’s skin of areas in contact with the
pad at a minimum of 30 minutes or as directed by a physician.
• Always consult the controller opera manual before connecng this
product.
CAUTION
• Do not use sharp objects or pins with this product.
• Do not clean this product. If soiled, dispose of product according to
hospital protocol. This is a single pant use product.
• Always inspect the product for tears, cuts, holes, stains, or any other
damage before use. Always monitor more frequently pediatric pants
and pants with impaired circula
• Always use minimal layers of sheeng and inconnence pads. Too many
layers between the pant’s skin and the pad will reduce the cooling or
warming capastem.
Disposing of the product
Dispose of the product in accordance with your local waste management
policy.
Safety Precau�ons
• US Federal Law restricts this device to sale by or on the order of a
licensed physician.

This manual assists you with the operation of the C2Dx Model 8002-062-
612, 8002-062-622, and 8002-062-626 Mul-T-Pad® . Read this manual before
operating this product and keep a copy on le. Set methods and procedures
to educate and train your sta on the safe operation of this product.
Intended use
The T/Pump® localized therapy system supplies warm or cold water at
controlled temperatures. Delivery of the water is through the thermal transfer
devices (Mul-T-Pad) for localized temperature therapy. The T/Pump® is for use
in situations where temperature therapy is necessary or desired.
Localized temperature therapy is of particular benet in treating the following:
• Orthopedic such as acute injuries, chronic pain, lower back
pain, muscle spasm, and strains;
• Skin trauma such as abscesses, boils, bruises, burns and contusions;
• Other medical such as chronic s, s, phls,
tends, and IV inltra and symptoms such as inf and
localized pain.
Product descrip�on
The Mul-T-Pad is a lightweight polymer. The colder style connectors provide
the means to connect to the temperature controller. The button design allows
water to ow when the pad is folded to form a customized t.
Expected life
These Mul-T-Pad products have a 30 day single patient use expected life
upon rst use and under normal use conditions.
Contraindica�ons
For heating:
• Applica to a body surface with compromised blood ow (Ischemia,
area under pressure, arterial insuciency).
• Applica to a pant with an increased tendency to bleeding
(aggravates potenal for hemorrhage).
• Applica to a body surface with possibility of malignancy
metabolism is increased and therefore, the growth potenal of the
malignan
• Treatment of hematoma within st 24-48 hours (potenal for re-bleeding
and hemorrhage). Recent sprain or fracture (acute inammatory
response).
• In combina with topical sol whose toxicity may be aected by
the applicaat.
• In combinawith other heat sources.
For cooling:
• Applica to body surface with compromised blood ow (Ischemia,
area under pressure, arterial insuciency
• Applica to body surface with known vascular impairment such as
frostbite, arteriosclerosis or ischemia
• Applica to body surface in people with vity to cold, such
as people with Raynaud’s phenomenon, cold urcaria, cryoglobulinemia,
and paroxysmal cold hemoglobinuria
• Applicato body surface in people with impaired sensa
• In combina with topical sol whose toxicity may be aected by
the applica
Specifica�ons
Material rayon, ethylene vinyl acetate (EVA), polypropylene,
polyethylene
Model 8002-062-612 8002-062-622 8002-062-626
Length 18 in. 46 cm 22 in. 56 cm 26 in. 66 cm
Width 13 in. 33 cm 15 in. 38 cm 18 in. 46 cm
Compatible
controllers
T/Pump series temperature controllers
Environmental
conditions
Operating Storage and
transportation
Temperature 90 °F
(32.2 °C)
60 °F
(15.6 °C)
120 °F
(48 °C)
-20 °F
(-29 °C)
Relative humidity
30%
75%
10%
95%
C2Dx reserves the right to change specications without notice.
A
Figure 1: Batch lot code
Assessing the paent’s skin condin
Note: Follow your fa skin care protocol. The following instru are
recommendas.
1. Document ial skin assessment.
2. Check for any foreign items such as medical patches, IV’s, sutures.
3. Check for uids such as moisture or gels.
4. Verify the pad size is correct before applying to the pant.
Note: Apply the pad directly to the skin or add minimal layers.
Connec�ng the pad (colder style connectors)
1. Close the pinch clamps on the connector hose and
pad (Figure 2).
2. Insert the male coupling of pad into the female
coupling of hose. Press un you hear a click
(Figure 3).
3. With a light pull, make sure that you locked the
connectors.
4. Open all clamps on the connector hose and the
pad (Figure 4).
5. Insert the power cord into a wall outlet.
6. Press the power buon to turn on the controller. See
the controller instrufor use.
7. Check that the pad lls with water.
Note:
• Iodine based disinfectants will stain the product. Staining does not aect
the pant nor the use of the product.
• Do not use pins or sharp objects with this product.
• If you fold the pad, place the end of the pad that contains the tubing
away from the pant.
Rechecking the pa�ent’s skin condi�on
Check the patient at regular intervals as directed by hospital protocol. Note any
change in the skin integrity that relates to:
• Excessive moisture - dry the skin surface by wiping away the moisture
• Color of the epidermis
• Skin texture
• Pant’s skiacceptable to connue therapy
Check the pad
Check the pad at regular intervals as directed by hospital protocol.
• p
• water status
• dry surface
• leaks
• cracks
Defibrilla�on considera�ons
1. Remove the pad to expose pant’s chest.
2. Remove excess moisture.
Disconnec�ng the pad from the hoses
1. Power ontroller.
2. Close pad clamps (Figure 2).
3. Press down on the thumb tab of the female coupling. Pull the male
coupling out to disconnect (Figure 5).
4. Discard pad afacility protocol.
Note: Do not discard the controller connector hose after use, save for next
use.
Figure 5: Disconnect
Figure 2: Close
Figure 4: Open
Figure 3: Connect
Opera�onIntroduc�onIntroduc�on
Contact informa�on
Contact C2Dx Customer Service at 1-888-902-2239.
C2Dx, Inc.
555 E. Eliza St. | Ste. A
Schoolcraft, MI 49087 USA
Have the Lot batch code of your C2Dx product available when calling
C2Dx Customer Service or Technical Support. Include the Lot batch code
in all written communication.

Doc Title: Material Specicon/Drawing (DWG) Template – Normal (8.5 x 11)
Doc Number: FM-03-6 Rev:0 (See Chng. Mgmt.)
C2DxTM, Inc. | 555 East Eliza St. | Suite A | Schoolcraft, MI 49087 |T: 888.902.2239 |c2dxinc.com
1. Fold as shown in Picture A, keeping tle page (page 1) facing
front.
Picture A: Fold Example
NOTE: This portion of the
document should not
appear on produced
Labels or IFUs
C2Dx Inc.
1-888-902-2293
Dimensions:
11-inch (width) x
8.5-inch folded to
3 5/8 x 8 ½ per
folding
inons.
Color/Material/Finish:
Color graphics on
white background.
20# bond or
equivalent
Label Stock:
N/A
Description/Type:
Inons For Use
Part Number:
8002-009-131
Rev.
2
This document contains condenal and proprietary informan that may not be reproduced or distributed, in
whole or in part, without wrien authorizaon from C2Dx, Inc. © 2020 C2Dx Inc.
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2
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