Stryker T/Pump Series User manual

2017/10 E.1 101515 REV E www.stryker.com
T/Pump® Series Localized Temperature Therapy
System
TP700
TP700C
Operations Manual

sample text

www.stryker.com 101515 REV E
English
EN
Symbols
Operating instructions/Consult instructions for use
General warning
Caution
Do not puncture
Warning non-ionizing radiation
Catalogue number
Serial number
Manufacturer
For US Patents see www.stryker.com/patents
Dangerous voltage
Type BF applied part
Medical Equipment Recognized by Underwriters Laboratories LLC With Respect to Electric
Shock, Fire, and Mechanical Hazards only in accordance with UL 60601-1: 2003 and CAN/
CSA-C22.2 No. 601-1, ASTM F 2196-2002
Warm water fill line
Cold water fill line
Water levels
Water flow
ONLY
CAUTION
Federal law (USA) restricts this device to sale by or on the order of a physician.

sample text

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Table of Contents
Warning/Caution/Note Definition ...............................................................................................................1-2
Summary of safety precautions.................................................................................................................1-3
Introduction...........................................................................................................................................1-4
Product description...........................................................................................................................1-4
Indications for use............................................................................................................................1-4
Expected service life.........................................................................................................................1-4
Contraindications .............................................................................................................................1-5
Specifications..................................................................................................................................1-5
Product illustration............................................................................................................................1-6
Product keypad................................................................................................................................1-7
Contact information ..........................................................................................................................1-7
Serial number location ......................................................................................................................1-8
Operation .............................................................................................................................................1-9
Connecting single or multiple pads.......................................................................................................1-9
Connecting and disconnecting the Clik-Tite connectors............................................................................ 1-9
Connecting and disconnecting the Colder Connectors ........................................................................... 1-10
Opening and closing hose pinch clamps ............................................................................................. 1-10
Starting the pump........................................................................................................................... 1-11
Starting therapy cycles.................................................................................................................... 1-12
Stopping the pump ......................................................................................................................... 1-12
Storing the pump, short term............................................................................................................. 1-13
Storing the pump, long term.............................................................................................................. 1-13
Draining the pump.......................................................................................................................... 1-13
Cleaning............................................................................................................................................. 1-14
Cleaning the external surface ........................................................................................................... 1-14
Cleaning the water circuit and hoses.................................................................................................. 1-14
Preventive maintenance ........................................................................................................................ 1-15
Accessories........................................................................................................................................ 1-16
EMC Information.................................................................................................................................. 1-18
Warranty ............................................................................................................................................ 1-22
Warranty exclusion and damage limitations ......................................................................................... 1-22
Return authorization........................................................................................................................ 1-22
Damaged product........................................................................................................................... 1-22
International warranty clause............................................................................................................ 1-22

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Warning/Caution/Note Definition
The words WARNING,CAUTION, and NOTE carry special meanings and should be carefully reviewed.
WARNING
Alerts the reader about a situation which, if not avoided, could result in death or serious injury. It may also describe
potential serious adverse reactions and safety hazards.
CAUTION
Alerts the reader of a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the
user or patient or damage to the product or other property. This includes special care necessary for the safe and
effective use of the device and the care necessary to avoid damage to a device that may occur as a result of use or
misuse.
Note: Provides special information to make maintenance easier or important instructions clearer.

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Summary of safety precautions
Carefully read and strictly follow the warnings and cautions listed on this page. Service only by qualified personnel.
WARNING
• Always fill the pump reservoir with water before operating. Do not plug in the product until you fill the water reservoir.
• Always plug the product into a hospital grade wall outlet.
• Do not attach the power cord to any moving parts of the bed frame or any location that may pinch or cause power
cord damage. Improper routing can cause power cord damage and possible electrical shock.
• Always set the temperature as directed by a physician.
• Always use the T/Pump with Mul-T-Pad accessories. Do not use with competitor pads.
• Risk of explosion. Do not use in the presence of flammable anesthetics.
• Always check the skin integrity of the body surface that therapy is applied. Evaluate patient response to the
temperature application.
• Always check the patient’s skin for adverse reactions every 30 minutes or as directed by the physician.
• Do not place additional heat sources between the patient and the pad. Skin damage may result.
• Always allow for additional monitoring of the following groups or conditions. Pediatric patients. Patients with
impaired circulation (Ischemia). Closely monitor the areas of body that are beneath the thermal transfer devices
(Ischemia).
• Always unplug the product before cleaning or disinfecting to avoid the risk of shock.
• Risk of electric shock. Disconnect power before servicing or cleaning the T/Pump.
CAUTION
• Improper usage of the product can cause injury to the patient or operator. Operate the product only as described in
this manual.
• Do not modify the product or any components of the product. Modifying the product can cause unpredictable
operation resulting in injury to patient or operator. Modifying the product also voids its warranty.
• Federal law (USA) restricts this device to sale by or on the order of a physician.
• Do not cover the product with blankets, pillows, or other insulating materials. Air flow is required to maintain system
performance.
• Closely monitor the areas of body that are beneath the thermal transfer devices. Also check for areas of the body
for use of topical solutions, or other heat sources. These may interfere with the treatment prescribed.
• Always set the fluid temperature and monitor the temperature of the patient and patient skin condition as directed
by a physician.
• Do not use quaternary disinfectant solutions on the external surface of this product.
• Do not spray cleaning or disinfectant solutions onto the pump. Frequent or prolonged disinfectant solutions may
result in damage to the product.
• Do not use the product next to or stacked with other equipment. If next to or stacked is necessary, observe the
product to verify normal operation in the configuration in which it used.

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Introduction
This manual assists you with the operation or maintenance of your Stryker product. Read this manual before operating
or maintaining this product. Set methods and procedures to educate and train your staff on the safe operation or
maintenance of this product.
CAUTION
• Improper usage of the product can cause injury to the patient or operator. Operate the product only as described in
this manual.
• Do not modify the product or any components of the product. Modifying the product can cause unpredictable
operation resulting in injury to patient or operator. Modifying the product also voids its warranty.
Notes
• This manual is a permanent part of the product and should remain with the product even if the product is sold.
• Stryker continually seeks advancements in product design and quality. This manual contains the most current
product information available at the time of printing. There may be minor discrepancies between your product and
this manual. If you have any questions, contact Stryker Customer Service or Technical Support at 1-800-327-0770.
Product description
The T/Pump® Localized Temperature Therapy system delivers temperature controlled water. The water flows through
an impeller driven pump through a bi-lumen hose. The hose connects to thermal transfer devices that can be applied
over, under, or around the patient. Water temperature increases with the use of the heater. Water temperature
decreases with the use of ice. The system delivers and removes thermal energy to and from the local anatomical sites.
This occurs at the contact point of the patient skin and thermal transfer device to raise or lower the temperature of local
anatomical sites.
Indications for use
The T/Pump localized temperature therapy system is for use in supplying warm or cold water at controlled temperatures
via thermal transfer devices. This is for the application of temperature therapy in situations where a physician
determines that temperature therapy is necessary. Intended for adult and pediatric human patient’s skin as attended by
health care professionals and lay persons. For use in healthcare settings and home use.
Localized temperature therapy is of particular benefit in treating the following applications:
• Orthopedic conditions such as acute injuries, chronic pain, and 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.
For use with non-acute traumatized tissue, impaired mental status, insensate body surface, and oxygen therapy. If an
oxygen tent is in use, do not use the pump inside the tent.
Note: Applications are as determined by a physician.
Expected service life
The T/Pump controller has a two year expected service life under normal use conditions and with appropriate periodic
maintenance.

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Introduction
Contraindications
Stryker promotes the assessment of each patient and appropriate usage by the operator. Contraindications for this
product are for patients with the conditions specified below.
Heating contraindications include:
• Application to a body surface with compromised blood flow (Ischemia, area under pressure, arterial insufficiency)
• Application to a patient with an increased tendency to bleed (aggravates potential for hemorrhage)
• Application to a body surface with possible malignancy (tissue metabolism is increased and therefore, the growth
potential of the malignant tissues)
• Treatment of hematoma within the first 24 to 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
Cooling contraindications include:
• Application to a 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 patients with hypersensitivity to cold, such as people with Raynaud’s phenomenon,
cold urticaria, cryoglobulinemia, and paraxysmal cold hemoglobinuria
• Application to body surface in patients with impaired sensation
• In combination with topical solutions whose toxicity may be affected by the application of cold
Specifications
Models TP700 / TP700C
Temperature setpoints Fahrenheit 107° F, 100° F, 95° F, 50° F
Temperature setpoints Celsius 42° C, 38° C, 35° C, 10° C
Therapy duration 20 or 30 minutes or continuous cycle
Classification Class I equipment with Type BF applied part suitable for continuous
operation. Not classified for protection against ingress of liquid. Not
classified for use in the presence of flammable anesthetics.
Size 11.5 in. x 8 in. x 8 in. 29.2 cm x 20.3 cm x 20.3 cm
Weight Reservoir empty 6.5 lb 2.9 kg
Reservoir filled with water to the
heating level
9 lb 4.0 kg
Maximum reservoir capacity 93 oz 2.75 l
Flow rate, minimum with pad attached 9 gph 34 lph
Average temperature accuracy ±2° F at 107° F ±1° C to 42° C
Maximum contact surface temperature 107° F 42° C
High limit safety temperature 110° F to 120° F 43.3° C to 49° C
Power cord International (harmonized) 3 wire cord set
Dual hose 10 ft 305 cm
Current leakage, maximum 100 µA
Ground resistance, maximum 0.5 mΩ
Electrical requirements Voltage 120 VAC ±10%
Frequency: 60 Hz
Current in amperes 3.1

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Introduction
Specifications (Continued)
Environmental conditions Operation Storage and transportation
Ambient operating temperature
90°F
(32.2°C)
60°F
(15.6°C)
120°F
(48°C)
-20°F
(-28°C)
Stryker reserves the right to change specifications without notice.
Product illustration
A
B
C
D
E
F
G
H
I
K
J
A Handle vents GHose storage
B Keypad H Cord storage
CFlow indicator I Tethered open cap
D Warm or cool delivery J Handle
E Therapy cycle times K On/Standby button
F Hose connections

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Introduction
Product keypad
A
B
C
DF
E
G
AIndicator / Warning light Red warning LED flashes with a short audible beep to
inform the operator that the product has reached the
desired temperature or is moving to the next cycle
BWater flow Check hoses or clamps for kinks or occlusions
CWater level Check water level
DSetpoints Toggle through the four setpoints, temperature in C
and F
EOn/Standby button Green indicates the unit is on / Yellow indicates power
is supplied to the unit but the unit is not on
FTherapy cycles Continuous cycle, 30 minute cycle, or 20 minute cycle
GSetpoint lock Prevents tampering of settings
Contact information
Contact Stryker Customer Service or Technical Support at: 1-800-327-0770.
Stryker Medical
3800 E. Centre Avenue
Portage, MI 49002
USA
To view your operations or maintenance manual online, see https://techweb.stryker.com/.
Have the serial number (A) of your Stryker product available when calling Stryker Customer Service or Technical
Support. Include the serial number in all written communication.

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Introduction
Serial number location

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Operation
Connecting single or multiple pads
The Mul-T-Pad products provide the interface for delivering temperature therapy. The unique button design allows water
to flow and provides trouble-free operation when the pad is folded to form a customized fit. You apply the pads to the
part of the body that require therapy. The circulating water maintains the pad at the setpoint temperature.
The pad is connected to the pump with Clik-Tite or Colder connectors.
You can interconnect the Mul-T-Pad (Figure 1-1 on page 1-9 ) by using the Clik-Tite or Colder style connectors to
provide therapy to more than one body part at a time (Figure 1-2 on page 1-9).
Figure 1-1: Localized temperature system with single
pad
Figure 1-2: Localized temperature therapy system with
multiple pads
Connecting and disconnecting the Clik-Tite connectors
TP700 has Clik-Tite style connectors.
To connect the Clik-Tite connectors from the hose to the pad:
1. Insert the male fittings into the female fittings with a twisting motion (Figure 1-3 on page 1-9 and Figure 1-4 on page
1-9).
Figure 1-3: Connecting fittings Figure 1-4: Twist fittings
2. After you insert fittings (Figure 1-5 on page 1-9), snap the lock ring into place (Figure 1-6 on page 1-9).
Figure 1-5: Insert fittings Figure 1-6: Lock ring

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Operation
Connecting and disconnecting the Clik-Tite connectors (Continued)
3. To disconnect, reverse the procedure.
Connecting and disconnecting the Colder Connectors
TP700C has Colder style connectors
To connect Colder connectors from the hose to the pad:
1. Insert the male coupling into the female coupling (Figure 1-7 on page 1-10). When you hear an audible click, you
have joined the connectors.
Figure 1-7: Connecting couplings
2. To disconnect, press down on the thumb tab (A) of the female coupling. The couplings will partially disconnect.
3. Pull the mail coupling out to disconnect (Figure 1-8 on page 1-10).
Figure 1-8: Disconnecting couplings
Opening and closing hose pinch clamps
To open or close the hose pinch clamps:
1. Open the clamp by pushing on the serrated end (Figure 1-9 on page 1-10).
Figure 1-9: Open the clamp Figure 1-10: Close the clamp
2. Close the clamp by pressing the clamp together (Figure 1-10 on page 1-10).

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Operation
Starting the pump
WARNING
• Always fill the pump reservoir with water before operating. Do not plug in the product until you fill the water reservoir.
• Always plug the product into a hospital grade wall outlet.
• Do not attach the power cord to any moving parts of the bed frame or any location that may pinch or cause power
cord damage. Improper routing can cause power cord damage and possible electrical shock.
• Always set the temperature as directed by a physician.
• Always use the T/Pump with Mul-T-Pad accessories. Do not use with competitor pads.
CAUTION
• Federal law (USA) restricts this device to sale by or on the order of a physician.
• Do not cover the product with blankets, pillows, or other insulating materials. Air flow is required to maintain system
performance.
• Closely monitor the areas of body that are beneath the thermal transfer devices. Also check for areas of the body
for use of topical solutions, or other heat sources. These may interfere with the treatment prescribed.
To start the pump:
1. Before filling the pump reservoir, attach a pad to the connector hose (see Connecting single or multiple pads on
page 1-9). Make sure that there are no kinks in the hose or pad.
2. Open the hose clamps.
3. Open the fill cap on the top of the pump.
4. To fill for cooling
• Fill with cold water to the Cooling water line.
• Fill with ice to the full capacity of the reservoir.
Note: When using the pump for cooling, the ice will eventually melt and the setpoint will start flashing.
5. To fill for heating, fill with room temperature water to the heating water line.
6. Plug the pump into a properly grounded hospital grade wall outlet.
7. Press the On/Standby button. The light next to the selected temperature begins to flash.
8. Use the keypad to set the temperature as directed by the physician.
Notes
• After setting the temperature, press and hold the Setpoint lock button for two seconds to lock the setpoint.
• If you go past the desired setpoint, keep pressing the button to start at the beginning of the setpoint values.
• It takes about 15 minutes to reach the selected water temperature. The light next to the selected temperature
becomes steady.
• Check the water level. If the water level drops below the operating level, add water.
9. Apply the Mul-T-Pad to the patient as directed by a physician.
10. Position the pump at or above the level of the pad.
Note: Do not place the pump below the pads, water will drain into the pump during shut off. If the pump has been
overfilled or if you connected multiple pads, excess water can leak.

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Operation
Starting therapy cycles
WARNING
• Risk of explosion. Do not use in the presence of flammable anesthetics.
• Always check the skin integrity of the body surface that therapy is applied. Evaluate patient response to the
temperature application.
• Always check the patient’s skin for adverse reactions every 30 minutes or as directed by the physician.
• Do not place additional heat sources between the patient and the pad. Skin damage may result.
• Always allow for additional monitoring of the following groups or conditions. Pediatric patients. Patients with
impaired circulation (Ischemia). Closely monitor the areas of body that are beneath the thermal transfer devices
(Ischemia).
CAUTION
Always set the fluid temperature and monitor the temperature of the patient and patient skin condition as directed by a
physician.
Heat therapy is effective in the dilation of blood vessels, which increases the blood flow to the heated area.
Cooling therapy assists in the vasoconstriction, decreasing blood flow, and decreasing the metabolism in the affected
area.
To start therapy cycles:
1. Press the On/Standby button to turn the pump on.
2. Set the temperature setpoint. The unit will start to heat up.
3. Select the warming period for a 20 minute or 30 minute cycle. The LED turns solid and the selected temperature
LED flashes.
Notes
• The red warming LED flashes with a short audible beep to inform the operator the unit is at the set temperature.
The timed therapy is starting.
• When the 20 minute or 30 minute time period is completed, the heater and pump shuts off. The water flow to
the pads is stopped. The setpoint and therapy time LEDs blink to indicate the off time period.
• After the off time period is completed, the pump and heater restart.
• The time therapy LED goes solid and the setpoint LED flashes.
• After the setpoint is reached, the red LED flashes with a short audible beep to let the operator know the next
therapy cycle has started.
Stopping the pump
To stop the pump:
1. Press the On/Standby button. The standby light illuminates.
2. Unplug the product.
3. Close all of the hose clamps.
4. Disconnect the pads from the pump.
Note: To prevent water spillage, always raise the connections above the level of the pad and the pump before
disconnecting the pad from the pump.
5. Coil the hose and attach the Clik-Tite connectors together on the hose.
6. Secure the hose to the pump by using the tube set strap.

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Operation
Stopping the pump (Continued)
7. Wrap the power cord around the product.
Storing the pump, short term
Short term storage is less than one day.
To store the pump short term:
1. Close the hose clamps.
2. Disconnect the pads.
3. Connect the ends of the connector hoses together, where applicable.
4. Open the hose clamps.
5. Leave water in the reservoir.
6. Coil and fasten the hose using the tube set strap and wrap the power cord around the product.
Note: Change the water monthly or more often depending on use.
Storing the pump, long term
Long term storage is defined as more than one day.
To store the pump long term:
1. Drain the pump (see Draining the pump on page 1-13).
2. Coil and fasten the hose using the tube set strap and wrap the power cord around the product.
Draining the pump
To drain the pump:
1. Disconnect the pump from AC power.
2. Clamp the hose clamps.
3. Disconnect the pads or hoses from one another, keep the hoses at or above the level of the pump.
4. Open the hose clamps.
5. Remove the fill cap and invert the pump over a sink to drain.
6. Replace the fill cap after all of the fluid has drained from the hoses and reservoir.
7. Connect the ends of the connector hoses together, where applicable.

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Cleaning
Empty and clean the pump on a monthly basis following these procedures. Complete this process more often depending
on use.
WARNING
Always unplug the product before cleaning or disinfecting to avoid the risk of shock.
CAUTION
• Do not use quaternary disinfectant solutions on the external surface of this product.
• Do not spray cleaning or disinfectant solutions onto the pump. Frequent or prolonged disinfectant solutions may
result in damage to the product.
Cleaning the external surface
Recommended cleaning agents include:
• A clean damp cloth and mild soapy water
• Phenolic disinfectant or 10% bleach solution
To clean the external side of the pump:
1. Unplug the controller.
2. Wipe the outside of the product with the following:
a. Using a clean, soft cloth moistened with a mild soap and water solution to remove foreign material
b. Using a clean, soft cloth moistened with a phenolic disinfectant or 10% bleach solution.
3. Follow specified contact time in accordance with the manufacturer’s instructions for use.
4. Using a clean, soft cloth, wipe the outside of the product with water.
5. Dry the external surface with a clean, dry cloth.
Cleaning the water circuit and hoses
Tools Required:
• Disinfectant Cleaner 2.0 (8001-999-333)
• Personal protective equipment, based on cleaning agent manufacturer’s instructions
• Soft, lint free cloth (2 or more)
1. Prepare a germicidal solution according to the manufacturer’s instructions for the Disinfectant Cleaner 2.0 .
2. Drain the pump.
3. Connect the hose set together, where applicable, or attach a pad to the connector hose.
4. Fill the reservoir to the heating water line on the back of the reservoir.
5. Select 95° F (35° C) temperature on the keypad.
6. Press the On/Standby button to start the pump.
7. Circulate the solution for one hour.
8. Drain the solution from the reservoir.
9. Rinse and drain the reservoir with water.
10. Dry the reservoir inside and outside with a dry, lint free cloth.

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Preventive maintenance
Remove product from service before you perform the preventive maintenance inspection. Check all items listed during
annual preventive maintenance for all Stryker Medical products. You may need to perform preventive maintenance
checks more often based on your level of product usage. Service only by qualified personnel.
WARNING
Risk of electric shock. Disconnect power before servicing or cleaning the T/Pump.
Note: Change the water monthly or more often depending on use.
Inspect the following items:
Line cord, the plug, and the housing for cuts or cracked insulation and quality of the strain relief, if damaged
replace
Membrane panel for cuts or cracks, if damaged replace
Plastic parts on the pump for cracks
Connectors for cracks and missing O-rings, replace connectors if necessary
Hose connections and connectors function properly
Pads and hoses are free from tears, cracks, and water leaks
Refer to the T/Pump Maintenance Manual Functional Checks section that and complete during preventive maintenance.
Inspection Value Okay Action Needed Action Taken
Measure current
leakage <100 µA
Product serial number:
Completed by:
Date:

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Accessories
These accessories may be available for use with your product. Confirm availability for your configuration or region. Call
Stryker Customer Service: 1-800-327-0770.
Test tools
Catalog Number Product Name Number in Carton
TPT9 Measures the temperature and water
flow
1
100925000 Test probe 1
Cleaner
Catalog Number Product Name Number in Carton
8001-999-333 Disinfectant cleaner 2.0 1
Optional accessories
Catalog Number Product Name Number in Carton
TPS2 Temperature therapy stand with
storage basket and cord hooks
1
TPIV IV pole mount plate 1
Notes
• Only use Mul-T-Pad products with the T/Pump. The unique button design allows optimal water flow and provides
trouble-free operation when the pad is folded.
• The Mul-T-Pad series products with Clik-Tite connectors can be interconnected to provide therapy to more than
one body site at a time.
Mul-T-Pad
Model Connector Length Width Expected life
in days /
single patient
use
Material Quantity per
carton
8002-062-012 Clik-Tite 18 in. (46 cm) 13 in. (33 cm) 30 Nonwoven
fabric on one
side, pliable
polymer on
the other side
20
8002-062-022 Clik-Tite 22 in. (56 cm) 15 in. (38 cm) 30 Nonwoven
fabric on one
side, pliable
polymer on
the other side
20
8002-062-026 Clik-Tite 26 in. (66 cm) 18 in. (46 cm) 30 Nonwoven
fabric on one
side, pliable
polymer on
the other side
10
8002-062-222 Clik-Tite 22 in. (56 cm) 15 in. (38 cm) 90 days /
reusable
Heavy polymer,
reusable
10