Stryker Mul-T-Pad 8002-062-612 User manual

Stryker Medical, a division of Stryker Corporation (“Stryker”) 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 a maximum
of 30 day use period. “Use” period begins when such devices individual
package is opened. Stryker’s obligation under this warranty is expressly limited
to supplying a product replacement, at its option, any product which is, in
the sole discretion of Stryker, found to be defective. If requested by Stryker,
products for which a claim is made shall be returned prepaid to the factory.
Any improper use or any alterations or repair by others in such manner as in
Stryker’s judgement affects the product materially and adversely shall void this
warranty. Any repair of Stryker products using parts not provided or authorized
by Stryker shall void this warranty. No employee or representative of Stryker is
authorized to change this warranty in any way.
Warranty exclusion and damage limitations
The express warranty set forth herein is the only warranty applicable to the
product. Any and all other warranties, whether express or implied, including
any implied warranty of merchantability or fitness for a particular purpose
are expressly excluded by Stryker. In no event shall Stryker be liable for
incidental or consequential damages.
Return authorization
Product cannot be returned without prior approval from the Stryker Customer
Service Department. An authorization number will be provided which must be
printed on the returned product. Stryker reserves the right to charge shipping
and restocking fees on returned product. Special, modified, or discontinued
products are not subject to return.
Damaged merchandise
ICC Regulations require that claims for damaged product must be made with
within fifteen (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 notification, Stryker will file 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
Stryker within the fifteen (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.
International warranty clause
This warranty reflects U.S. domestic policy. Warranty outside the U.S. may
vary by country. Please contact your local Stryker Medical 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
Operations Manual
2014/12 B.0 8002-009-131 REV B www.stryker.com
Warranty
2014/12 8002-009-131 REV B www.stryker.com
Stryker Medical
3800 E. Centre Avenue
Portage, MI 49002
USA
Operation
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 patient to avoid the risk of cross-
contamination and infection.
• Do not use this product to position or transfer a patient.
• Do not allow hoses to fold, kink, or to wrap around a patient.
• Always pre-fill the pad before applying to the patient.
• Always check the patient’s skin condition of areas in contact with the
pad at a minimum of 30 minutes or as directed by a physician.
• Always consult the controller operations manual before connecting this
product.
CAUTION
• US Federal Law restricts this device to sale by or on the order of a
licensed physician.
• 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 patient use product.
• Always inspect the product for tears, cuts, holes, stains, or any other
damage before use. Always monitor more frequently pediatric patients
and patients with impaired circulation.
• Always use minimal layers of sheeting and incontinence pads. Too many
layers between the patient’s skin and the pad will reduce the cooling or
warming capabilities of the system.
Disposing of the product
Dispose of the product in accordance with your local waste management
policy.
Safety Precautions

This manual assists you with the operation of the Stryker 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 file. Set methods and procedures
to educate and train your staff 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 physicians determine temperature therapy is necessary
or desired.
Localized temperature therapy is of particular benefit in treating the following:
• Orthopedic conditions 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 conditions such as chronic arthritis, neuritis, phlebitis,
tendonitis, and IV infiltration; and symptoms such as infections and
localized pain.
Product description
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 flow when the pad is folded to form a customized fit.
Expected life
These Mul-T-Pad products have a 30 day single patient use expected life
upon first use and under normal use conditions.
Contraindications
For heating:
• Application to a body surface with compromised blood flow (Ischemia,
area under pressure, arterial insufficiency).
• Application to a patient with an increased tendency to bleeding
(aggravates potential for hemorrhage).
• Application to a body surface with possibility of malignancy (tissue
metabolism is increased and therefore, the growth potential of the
malignant tissues).
• Treatment of hematoma within first 24-48 hours (potential for re-bleeding
and hemorrhage). Recent sprain or fracture (acute inflammatory
response).
• In combination with topical solutions whose toxicity may be affected by
the application of heat.
• In combination with other heat sources.
For cooling:
• Application to body surface with compromised blood flow (Ischemia,
area under pressure, arterial insufficiency
• Application to body surface with known vascular impairment such as
frostbite, arteriosclerosis or ischemia
• Application to body surface in people with hypersensitivity to cold, such
as people with Raynaud’s phenomenon, cold urticaria, cryoglobulinemia,
and paroxysmal cold hemoglobinuria
• Application to body surface in people with impaired sensation
• In combination with topical solutions whose toxicity may be affected by
the application
Specifications
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%
Stryker reserves the right to change specifications without notice.
A
Figure 1: Batch lot code
Assessing the patient’s skin condition
Note: Follow your facilities skin care protocol. The following instructions are
recommendations.
1. Document initial skin assessment.
2. Check for any foreign items such as medical patches, IV’s, sutures.
3. Check for fluids such as moisture or gels.
4. Verify the pad size is correct before applying to the patient.
Note: Apply the pad directly to the skin or add minimal layers.
Connecting 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 until 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 button to turn on the controller. See
the controller instructions for use.
7. Check that the pad fills with water.
Note:
• Iodine based disinfectants will stain the product. Staining does not affect
the patient 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 patient.
Rechecking the patient’s skin condition
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
• Patient’s skin condition is acceptable to continue therapy
Check the pad
Check the pad at regular intervals as directed by hospital protocol.
• position
• water status
• dry surface
• leaks
• cracks
Defibrillation considerations
1. Remove the pad to expose patient’s chest.
2. Remove excess moisture.
Disconnecting the pad from the hoses
1. Power off the controller.
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 after use per facility 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
OperationIntroductionIntroduction
Contact information
Contact Stryker Customer Service at 1-800-327-0770.
Stryker Medical
3800 E. Centre Avenue
Portage, MI 49002 USA
Have the Lot batch code of your Stryker product available when calling
Stryker Customer Service or Technical Support. Include the Lot batch code
in all written communication.