Recovery+ and DVTherapy Operator s Manual. Models PS511 (Recovery+) and PS511A (DVTherapy)

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03-0221-01 R03 07/11/2012

Recovery+ and DVTherapy

Operator’s Manual

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1. Contact

Information

Pulsar Scientific, LLC

8 Stony Brook Street

Ludlow, MA 01056

www.pulsarscientific.com

Phone: 413-589-0851

Fax: 413-385-0003

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2. General Warnings and Cautions

WARNING: Observe all warnings and cautions prior to using the Recovery+ or

DVTherapy units.

WARNING

: Electrical shock hazard. Do not remove covers from devices.

WARNING

: Do not attempt to service internal components. Contact Customer Service.

WARNING

: The Recovery+ must be operated with the supplied power cord and plugged

into a 3-prong grounded wall outlet.

WARNING

: The DVTherapy external power supply must be operated with the supplied

power cord and plugged into a 3-prong grounded wall outlet.

WARNING

: Only operate DVTherapy with the external power supply provided – do not

attempt to use a different power supply.

WARNING

: If the integrity of the external power supply’s protective earth conductor is

in doubt, the DVTherapy must by run only off of its internal battery.

WARNING

: Do not operate units if there is damage to the units.

WARNING

: Do not operate units with a damaged or frayed power cord.

WARNING

: If pulsations or throbbing occur, the wrap is too tight. Loosen immediately.

WARNING

: Stop using device immediately if swelling occurs; consult a physician.

WARNING

: Devices are to be used only on the patient prescribed and only for its

intended use.

WARNING

: Ensure that the units are turned off and the power cord is unplugged from

the wall outlet prior to and while cleaning or disinfecting.

WARNING

: EQUIPMENT NOT SUITABLE FOR USE IN THE PRESENCE OF A

FLAMMABLE ANESTHETIC MIXTURE WITH AIR OR WITH OXYGEN OR

NITROUS OXIDE.

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General Warnings (Continued)

WARNING

: Do not operate units in a wet environment.

WARNING

: Never spill liquid of any kind on units.

WARNING

: Do not spray liquids of any kind on units.

WARNING

: Do not overfill the reservoir of the Recovery+.

WARNING

: If the units get wet, unplug the power cord from the wall outlet and allow

units to dry before use.

WARNING

: Never push objects of any kind into the openings of units.

WARNING

: Do not insert fingers or foreign objects into Recovery+ reservoir.

WARNING

: Do not drink or ingest Recovery+ liquid.

CAUTION

: Contains no serviceable parts. Contact customer support.

CAUTION

: Do not subject the units to physical shock such as dropping the units.

CAUTION

: Do not place units in an autoclave.

CAUTION

: Use only Pulsar Scientific approved therapy wraps.

CAUTION

: Do not use therapy wraps that were not received in sealed bag or sealed

container.

CAUTION

: Disposable therapy wraps are designed for single patient use only and may

only be used on the same patient for the length of the treatment.

CAUTION

: Therapy wraps are non-sterile unless specifically labeled sterile.

CAUTION

: Non-sterile therapy wraps should never be directly applied to an open

wound or breached skin.

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General Warnings (Continued)

CAUTION

: Do not attempt to sterilize the device or therapy wraps by any means.

CAUTION

: A licensed healthcare practitioner must select the correct temperature for

cold therapy.

CAUTION

: Follow the prescribed instructions of the physician for area, frequency, and

duration of treatment.

CAUTION

: Therapy wraps are to be fitted initially by a healthcare professional that is

familiar with the purpose for which the wraps are used.

CAUTION

: A healthcare professional is responsible for providing wearing instructions

and precautions to care providers involved in the care of the patient.

CAUTION

: A healthcare provider must monitor the patient’s use of the devices, assuring

appropriate use and application of the therapies.

CAUTION

: Slots and openings in the Recovery+ are provided for ventilation. Do not

block or cover the openings at anytime.

CAUTION

: Use the handle when moving the Recovery+ and pick up the DVTherapy by

its housing when moving the units. Do not attempt to lift or move the units by pulling the

units by the therapy wrap hoses, power cords, or remote control cord.

CAUTION

: The Recovery+ Remote Control Connector is for use only with the

Recovery+ Remote Control. Do not attempt to plug any other device into the Recovery+

Remote Control connector. Attempting to plug other devices into the remote control

connector may damage the Recovery+ and/or the Remote control.

CAUTION

: Only use the provided liquid to fill the Recovery+ Reservoir.

CAUTION

: Do not use the Recovery+ or DVTherapy near equipment that generates

electromagnetic or other interferences as this may be harmful to the units. Do not stack

equipment.

CAUTION

: The use of accessories, transducers and cables other than those supplied by

Pulsar Scientific may result in increased emissions or decreased immunity of the

Recovery+ and DVTherapy units.

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3. Contraindications

Contraindications

The Recovery+ and DVTherapy should not be used in the following instances • Presumptive evidence of Congestive Heat Failure (CHF)

• Suspected/observed pre-existing Deep Venous Thrombosis (DVT) or pulmonary embolism • Suspected/observed deep acute and venal thrombosis (phlembothrombosis)

• Suspected/observed inflammatory phlebitis process • Suspected/observed pulmonary edema

• Suspected/observed acute inflammations of the veins (thrombophlebitis) • Suspected/observed decompensated cardiac insufficiency

• Suspected/observed arterial dysregulation • Suspected/observed erysipelas

• Suspected/observed carcinoma and carcinoma metastasis in the affected extremity • Suspected/observed decompensated hypertonia

• Suspected/observed acute inflammatory skin diseases or infection • Suspected/observed venous or arterial occlusive disease

• Determine venous and lymphatic return is undesirable • Suspected/observed patient has Raynaud’s Disease • Suspected/observed poor peripheral circulation • Suspected/observed hypersensitivity to cold

• Patient therapy contact on extremity containing a fracture • Extremities that are sensitive to pain

It is also not recommended that the devices be used on a limb where the wraps would interfere with open wounds, vein ligation, gangrene, dermatitis, recent skin graft, massive edema, or extreme deformity of the leg. The devices should not be used where increased venous or lymphatic return is undesirable.

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4. Indications for Use

The Recovery+ and DVTherapy therapy are designed to be used, as prescribed by a physician, for heating, cooling, and pneumatic compression. The operation or safety of the devices may be impaired if the system is used in a manner other than specified.

Indications

Including:

• Decrease the risk of Deep Venous Thrombosis (DVT) • Aid the blood flow back to the heart

• Treat and assist healing of cutaneous ulceration (wounds), reduce wound healing time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications

• Treatment of pain and swelling of acute periarticular processes, treatment of pain and swelling following mobilization of shoulder stiffness under anesthesia, treatment of pain and swelling postoperatively for bones, joints and soft tissue, treatment of pain and swelling caused by musculoskeletal contusions and athletic injury

• Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post mastectomy edema and chronic edema • Reduction of edema associated with soft tissue injuries such as ligament sprains, postoperative

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5. Device

Description

The Recovery + (model PS511) is a thermal compression system that supplies hot or cold fluid at precisely controlled temperatures to specially designed therapy wraps. The system provides heat and cool therapy with or without pneumatic compression. The Recovery+ also accepts the installation of the DVTherapy pneumatic compression system. With the DVTherapy docked into the Recovery+, the system provides compression therapy that aids in the prevention of Deep Vein Thrombosis (DVT). The DVTherapy unit is a compact, portable pneumatic compression system that can be used stand-alone to reduce the risk of DVT formation, or it may be docked into the Recovery+ to run simultaneously with thermal compression therapies.

Therapy Features

• The Recovery+ provides therapy temperatures adjustable between 43º F - 50º F (Cool Therapy), 105ºF (Heat Therapy), and alternating between 49ºF to 105º F (Alternating Therapy)

• The Recovery+ provides treatment for edema with selectable pneumatic compression settings of 15 mmHg, 50 mmHg, and 75 mmHg

• The DVTherapy provides pneumatic compression to reduce the risk of DVT formation in the calf (50 mmHg compression) and foot (120 mmHg compression)

• The Recovery+ and DVTherapy units may be each used individually to provide their respective therapies, or the two units may be combined to provide both thermal compression and DVT prevention therapies a single unit.

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5. Device Description (Continued)

5.1 Recovery+

Description

Keypad and Display

Reservoir Reservoir Level Window Remote Control Connector DVTherapy Release Button Recovery+ Remote Control SD Card Socket

Air Filter Panel Assembly

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5. Device Description (Continued)

Water In Port Water Out Port Air Out Port

DVTherapy Compression Fittings (only available if DVTherapy installed)

Power Cord Connection Main Power Switch

Thermal Compression Wrap Connections

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5. Device Description (Continued)

Filling the Recovery+ Reservoir

WARNING

: Do not overfill the reservoir of the Recovery+.

Add liquid here until the fluid is visible between Min and Max level indicators.

If the liquid level is not above the Min level indicator, more liquid should be added.

Note: after starting a therapy, the liquid level may drop below the Min level. If this occurs, add liquid until

the level is again between the Min and Max level indicators.

When running the Recovery+ after adding liquid, allow the unit to run a couple minutes with the cap removed to allow any air in the system to escape.

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5. Device Description (Continued)

Recovery+ Keypad

Key Functions:

Power Key: Powers unit On and Off

Stop therapy (Preset Therapy)

Make selection (Tech Mode)

Up Key: Adjust temperature (Cool Therapy)

Start therapy (Preset Therapy)

Menu navigation (Tech Mode)

Down Key: Adjust temperature (Cool Therapy) Menu navigation (Tech Mode)

Cool Therapy Key: Start/Stop Cool therapy

Display real-time temperature and pressure

Start Alternating therapy (when pressed with Heat key)

Heat Therapy Key: Start/Stop Heat therapy

Display real-time temperature and pressure

Start Alternating therapy (when pressed with Cool key) Display Cool Therapy Key Heat Therapy Key Compression Therapy Key DVT Therapy Key Power Key Up Key Down Key

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5. Device Description (Continued)

Compression Therapy Key: Start/Stop compression therapy

Change compression pressure set point (15, 50, 75 mmHg)

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5. Device Description (Continued)

Recovery+ Remote Control Keypad

Key Functions:

Functions identical to Recovery+ Keypad

Display Cool Therapy Key Heat Therapy Key Compression Therapy Key DVT Therapy Key Power Key Up Key Down Key

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5. Device Description (Continued)

5.2 DVTherapy

Description

DVT Wrap Connections

Keypad and Display

DVTherapy External Power Supply Power Cord

DVTherapy Power Supply Connection

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5. Device Description (Continued)

DVTherapy Keypad

Key Functions:

Power Key: Powers unit On and Off

Make selection (Tech Mode)

Up Key: No Function during therapy

Menu navigation (Tech Mode)

Down Key: No Function during therapy Menu navigation (Tech Mode)

Run Key: Start/Stop DVT Therapy

Up Key Power Key

Down Key Run Key

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6. Items Included with the Recovery+ and DVTherapy System

Note: Depending on the prescribed therapy, the included items may differ. Verify with the healthcare provider which therapies have been prescribed prior to administering therapy to the patient.

The following items are included with the Recovery+ system:

• Recovery+ Therapy Unit • 8’ Power Cord

• Recovery+ Remote Control • 7-foot Hose Assembly

• 32 oz. Liquid Bottle (liquid included).

• Recovery+ and DVTherapy Operator’s Manual

The following items are included with the DVTherapy system:

• DVTherapy Unit

• DVTherapy Power Supply and Charger • 3’ Power Cord.

• Recovery+ and DVTherapy Operator’s Manual

If both the Recovery+ and the DVTherapy units were prescribed, all above items are included. If any of these items are missing, please contact the clinic or hospital that prescribed the

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6. Items included with the Recovery+ and DVTherapy System (cont.)

Therapy Wraps

Along with the Recovery + and DVTherapy systems, all therapy wraps necessary for the prescribed treatment should be included in individually sealed, unopened bags. These wraps may be marked “Sterile” or “Non-Sterile” depending on the type of treatment recommended by the physician.

The type and number of therapy wraps included depend on the therapy as prescribed by the physician. Verify with the physician that the correct therapy have been included prior to administering therapy to the patient.

If any of the therapy wraps are missing, please contact the clinic or hospital that prescribed the unit, or Pulsar Scientific Customer Service.

CAUTION

: Do not use therapy wraps that were not received in sealed bag or sealed

container.

CAUTION

: Disposable therapy wraps are designed for single patient use only and may

only be used on the same patient for the length of the treatment.

CAUTION

: Therapy wraps are non-sterile unless specifically labeled sterile.

CAUTION

: Non-sterile therapy wraps should never be directly applied to an open

wound or breached skin.

CAUTION

: Use only sterile therapy wraps over wounds or breaks in the skin.

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7. Environmental

Conditions

• The Recovery+ and DVTherapy are intended for indoor use only. • Do not expose devices to direct sunlight.

• Do not operate devices below 0°C (32°F)

•

Do not expose devices to heat exceeding 65° C (149° F)

•

Do not operate the devices if they have been stored in freezing conditions. Allow therapy wraps to warm to room temperature if exposed to temperatures below 5°C (41° F).

• Do not wear therapy wraps below freezing temperatures (0°C / 32°F) as damage to the therapy wraps may occur.

•

Do not expose the devices to a direct heat source with temperatures exceeding 50° C (122° F) for extended periods of time.

Normal Operating Conditions:

• Temperature Range: 10°C (50°F) to 40°C (105°F) • Relative Humidity: 30% to 70%

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8. Setup

Instructions

8.1 Setting up the Recovery+

1. Place the Recovery + unit upright on a level surface and at least 1-foot from any wall or other obstruction that could restrict airflow to the unit.

2. Verify that the main power switch located on the rear panel of the unit is in the OFF position.

If a DVTherapy unit was included with your Recovery+ system:

3. Insert the DVTherapy unit into the back of the Recovery+ unit. Continue pushing the DVTherapy unit into the Recovery+ until it is fully seated.

If DVT prevention therapy was prescribed, follow steps 4-7. For all other therapies, skip to step 8.

4. Unpack and apply the prescribed DVT prevention therapy wraps to the body portions as instructed by the health care professional prescribing the device.

5. On the rear panel, and at the top of the unit, locate the fittings DVTherapy fittings which match those identified on the DVT prevention therapy wraps.

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8. Setup Instructions (continued)

Note: Depending on the DVT prevention therapy prescribed, the number of wrap fittings, and the particular limb (Foot or Calf) available to connect to the DVTherapy may vary. If you have any questions contact the clinic or hospital that prescribed the unit.

When using the DVTherapy for single leg therapies, the DVTherapy will inflate through the fittings labeled “Left” – the fittings labeled “Right” will not be used. Use “Foot Left” for single foot therapies, “Calf Left” for single calf therapies, “Foot Left” and Calf Left” for single foot and calf (AI) therapies.

6. To attach and secure the therapy wrap fittings, insert the wrap fitting into the rear panel connector. The fittings should make a “click” sound when inserted to indicate a secure connection. Repeat for each fitting. Note: to remove fittings press down on the metal tab and pull fitting out of the connector.

Example: DVT Foot Left

Example:

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8. Setup Instructions (continued)

7. Plug the supplied power cord into the Recovery+ unit and into a wall power outlet. The Recovery + is now ready for DVT prevention therapy.

If Heat, Cool, Alternating, or Compression, Therapy was prescribed:

8. If the reservoir cap has been removed, screw the coolant reservoir cap back onto the top of the unit.

9. Unpack and apply the prescribed thermal compression therapy wraps to the body portions as instructed by the health care professional prescribing the device.

10. Connect the 7-foot hose assembly to the therapy wrap used for treatment. The fittings should make a “click” sound when inserted to indicate a secure connection. The fittings on the therapy wrap and the fittings on the 7 foot hose assembly are sized so that they will only fit together in the correct manner. Note: to remove fittings press down on the metal tab and pull fitting out of the connector.

11. On the rear panel of the Recovery+, locate the fittings marked for “Water Out”, “Water In”, and for “Air Out.” Connect the large fittings to the “Water Out” and “Water In” ports on the rear panel of the unit (either fitting may be connected to water ports). The fittings should make a “click” sound when inserted to indicate a secure connection. Note: to remove fittings press down on the metal tab and pull fitting out of the connector.

12. Connect the small fittings to the “Air Out” port. The fitting should make a “click” sound when inserted to indicate a secure connection. Note: to remove fittings press down on the metal tab and pull fitting out of the connector.

Water In Port

Water Out Port Air Out Port

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8. Setup Instructions (continued)

13. Plug the supplied power cord into the Recovery+ unit and into a wall power outlet. The Recovery + is now ready for thermal compression therapy

Removing the DVTherapy unit from the Recovery+

The DVTherapy unit should be allowed to recharge while installed within the Recovery+ unit for 3-8 hours prior to removing for portable use.

In order for the DVTherapy to recharge within the Recovery+, the power cord must be plugged into the back of the Recovery+ unit and into a wall power outlet, and the main power switch on the rear of the Recovery+ must be switched to the ON position.

14. Disconnect all wrap fittings from the back of the DVTherapy unit.

15. Press down on the release button on the top of the Recovery+ unit until the button is fully depressed.

16. The DVTherapy unit will be partially pushed out from the back of the Recovery+ unit. Once the release button has been fully depressed, the DVTherapy can be manually pulled out from the Recovery+ unit.

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8. Setup Instructions (continued)

Recovery+ Remote Control

The Recovery+ remote control connects to the Recovery+ and provides the same keypad keys as on the Recovery+ keypad. This allows remote control of the Recovery+.

To connect the Recovery+ Remote Control:

1. Insert the remote control connector into the front connector on the Recovery+. The connector will only allow connection in the correct orientation. Press the connector in until it locks into place.

2. The Remote control is ready for use.

3. To disconnect the remote control, press the metal tab on the front of the connector in towards the Recovery+ and then pull the connector out.

CAUTION

: The Recovery+ Remote Control Connector is for use only with the

Recovery+ Remote control. Do not attempt to plug any other device into the Recovery+

Remote Control connector. Attempting to plug other devices into the remote control

connector may damage the Recovery+ and/or the Remote control.

Remote control connector Release tab

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8. Setup Instructions (continued)

8.2 Setting up the DVTherapy

1. Unpack and apply the prescribed DVT prevention therapy wraps to the body portions as instructed by the health care professional prescribing the device.

2. On the rear panel, and at the top of the unit, locate the fittings DVTherapy fittings which match those identified on the DVT prevention therapy wraps.

Note: Depending on the DVT prevention therapy prescribed, the number of wrap fittings, and the particular limb (Foot or Calf) available to connect to the DVTherapy may vary. If you have any questions contact the clinic or hospital that prescribed the unit.

3. To attach and secure the therapy wrap fittings, insert the wrap fitting into the rear panel connector. The fittings should make a “click” sound when inserted to indicate a secure connection. Repeat for each fitting. Note: to remove fittings press down on the metal tab and pull fitting out of the connector.

Example: DVT Foot Left

Example:

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8. Setup Instructions (continued)

4. Plug the power cord into the Power Supply and Charger

5. Plug the Power Supply and Charger into the DVTherapy.

6. Plug the power cord into a wall power outlet.

7. The DVTherapy is now ready for use.

The DVTherapy unit should be allowed to recharge while plugged into the DVTherapy power supply for 3-8 hours before running off its rechargeable battery.

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10. Operating

Instructions

10.1 Recovery+ Operating Instructions: Preset Therapy Mode

Preset Therapy Mode (See Section 9.4 Recovery+ Programming) allows the Recovery+ to run preprogrammed therapies and limits the patient from changing certain therapy parameters. The

Recovery+ may be preprogrammed to include a therapy run Thermal Timers to repeatedly turn On and Off Cool, Heat, or Alternate therapy at regular intervals, and a master therapy timer can be set to run the therapy sequence for a defined amount of timer. See section 9.4 Recovery+ Programming for more information.

When running in Preset Therapy mode, changes can be made as follows: Change thermal therapy type (e.g. Change Heat to Cool): No

Turn on or Off DVT therapy: Yes

Change Cool Temperature: Yes

Add or change pneumatic compression: Yes

Follow the Setup Instructions in Chapter 8.1 prior to operating the Recovery+

1. Turn on the main power switch. The power switch is located on the rear panel of the unit. The screen will remain blank.

2. Press and hold the power key on the keypad for 2 seconds.

3. After a brief boot-up sequence the display will read “Press To Start”

4. To initiate the Preset therapy, press the Up key. Therapy will begin, and the screen will display the Preset therapy type. If a timer was programmed as part of the therapy, the time remaining on the timer will be displayed in the lower left corner.

5. The therapy will run until the timer has elapsed, in which “Press To Start” will again displayed.

Select Therapy Press

To Start

Select Therapy Cool 50°F

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10. Operating Instructions (Continued)

6. While Preset therapy is running, the therapy may be stopped by pressing the Power key momentarily (continuing to hold the Power key for 2 seconds will shut the Recovery+ off). After therapy has stopped, the Recovery+ will again display “Press To Start”

7. During Preset therapy, Compression therapy may be added or the pressure set point changed between 15, 50, and 75 mmHg by pressing the COMP key.

8. If Cool therapy is running as part of the Preset therapy, the preset temperature may be adjusted between 43°F -50°F by pressing the Up or Down keys.

Any anytime the unit is on, the Recovery+ may be shut off by pressing and holding the power key for 2 seconds. Shutting off the Recovery+ will stop any therapy that may currently be running.

If Thermal Timers were set as part of the Therapy Settings, the thermal therapy will run for the set Thermal On Time, and then the thermal therapy will suspend for the Thermal Off time. While the Thermal Off Timer is running, the time remaining for the Thermal Off Timer will be displayed next to the respective thermal therapy.

Once the Thermal Off Timer has elapsed, the thermal therapy will automatically resume.

Note: If the Thermal Timers are set to “Disabled”, the Thermal timer will default to 120 minutes On and 30 minutes Off for Cool therapy only.

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Select Therapy

10. Operating Instructions (Continued)

10.2 Recovery+ Operating Instructions: Manual Therapy Mode

Manual Therapy Mode (See Section 9 Advanced Setup) allows the use of all available Recovery+ therapies. When in Manual Therapy Mode, no therapy timers are available, and the therapies will run indefinitely unless manually stopped, or the Recovery+ is shut OFF. Cool therapy is an exception, and it will default its Thermal Timers to a fixed setting of 120 minutes On and 30 minutes Off. The Thermal Timers settings in Tech Mode have no effect on this fixed tiemr. Heat Therapy and Alternating Therapy may be unavailable if Heat is disabled in Tech Mode (See Section 9 Advanced Setup).

Follow the Setup Instructions in Chapter 8.1 prior to operating the Recovery+

1. Turn on the main power switch. The power switch is located on the rear panel of the unit. The screen will remain blank.

3. After a brief boot-up sequence the display will read “Select Therapy”

4. The Recovery+ is now ready for therapy selection

Any anytime the unit is on, the Recovery+ may be shut off by pressing and holding the power key for 2 seconds. Shutting off the Recovery+ will stop any therapy that may currently be running.

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10. Operating Instructions (Continued)

Cool Therapy

Cool Therapy passes cool fluid through the wrap for the management of pain, discomfort and swelling. If prescribed, Cool therapy can be used in combination with Pneumatic Compression therapy and/or DVT prevention therapy.

1. To initiate Cool Therapy, press the COOL key. The display will change and now read “Cool 50º F”. Therapy will begin and automatically cool the wrap to the preset temperature. 50º F is the default preset temperature for Cool Therapy.

2. The preset temperature may be adjusted between 43°F -50°F by pressing the Up or Down keys. 3. After the prescribed duration of therapy has completed, press and hold the COOL key down for 2

seconds to stop Cool therapy

Note: Cool Therapy will default to a fixed Thermal Timer setting 120 minutes On and 30 minutes Off when in Manual mode. The Thermal Timers settings have no impact on this when the

Recovery+ is set to Manual Mode.

While the Thermal Off Timer is running, the time remaining for the Thermal Off Timer will be displayed next to the Cool thermal therapy. After the 30 Off timer, Cool Therapy will

automatically resume.

The Cool Thermal Off Timer may be overridden by stopping and restarting Cool Therapy.

Select Therapy Cool 50°F

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10. Operating Instructions (Continued)

Heat Therapy

Heat Therapy passes warm fluid through the wrap for the management of pain and discomfort. Heat therapy can be used in combination with Pneumatic Compression therapy and/or DVT prevention therapy.

Note: Heat Therapy may be disabled on the Recovery+ depending on the particular therapy prescribed by the physician. If Heat is disabled, Heat therapy cannot be run in Manual therapy mode. See Section 9Advanced Setup.

1. To initiate heat therapy, press the HEAT key. The display will change and now read “Heat 105ºF”. Therapy will begin and automatically heat the wrap to the preset temperature. Heat therapy is fixed at 105º F

2. After the prescribed duration of therapy has completed, press and hold the HEAT key down for 2 seconds to stop Heat therapy.

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10. Operating Instructions (Continued)

Alternating Therapy

Alternating Therapy passes fluid through the wrap in an alternating cycle of Cool-Heat-Cool-Heat for the management of pain, discomfort, and swelling. During Alternating Therapy, the unit will cool down the circulating fluid to 49ºF for twenty (20) minutes and then heat up to 105ºF for ten (10) minutes. This cycle is repeated until the therapy is stopped. Alternating therapy can be used in combination with Pneumatic Compression therapy and/or DVT prevention therapy.

Note: Alternating Therapy may be disabled on the Recovery+ depending on the particular therapy prescribed by the physician. If Heat is disabled, Alternating therapy cannot be run in Manual therapy mode. See Section 9Advanced Setup.

1. To initiate alternating therapy, press the COOL and HEAT keys simultaneously. The display will change and now read “Cool 49°F Heat 105°F”. Therapy will begin and automatically alternate the temperature of the fluid passing through the wrap to the preset temperatures. The Alternating therapy temperatures are fixed at 49º and 105ºF.

2. After the prescribed duration of therapy has completed, press and hold either the COOL or HEAT key down for 2 seconds to stop Alternating Therapy.

Pneumatic Compression Therapy

Compression therapy provides compressed air to the therapy wrap and transfers pressure to the treatment site. This added external pressure aids in reducing the pooling of blood and lymphatic fluid in the

targeted extremity. The compression treatment provided by the unit uses a preset pressure setting and cycle time. Compression therapy may be applied at 15 mmHg, 50 mmHg, or 75 mmHg. The

compression therapy cycle consists of inflation to and holding at the setpoint pressure over a period of approximately 30 seconds (inflation times and hold times vary depending on wrap size and pressure setpoint, but are they generally 15-20 seconds of inflation and 10 seconds of hold time). After holding at pressure for a brief period of time, the pressure is released. The cycle repeats 30 seconds after deflation starts.

Pneumatic compression therapy may be used in combination with Cool, Heat, or Alternating therapy and may also be combined with DVT prevention therapy.

Select Therapy Cool 49°F Heat 105°F

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10. Operating Instructions (Continued)

1. To add Pneumatic Compression Therapy mode, press the COMP key. The display will change and now read “Comp 15 mmHg”. This will initiate compression therapy at 15 mmHg.

2. Repeatedly pressing the COMP key will sequentially change the compression setpoint to 50 mmHg and then 75 mmHg. Pressing COMP while the setpoint is at 75 mmHg will turn compression therapy OFF.

3. After the prescribed duration of therapy has completed, press and the COMP repeatedly until “Comp 75 mmHg” is displayed, then press COMP one more time to turn off compression therapy.

DVT Prevention Therapy (with the DVTherapy installed in the Recovery+)

DVT prevention therapy is only available on the Recovery+ if the DVTherapy has been installed with the Recovery+ unit.

DVT prevention therapy is used in combination with specially designed therapy wraps to transfer pressure to either the foot or calf using compressed air.

The DVT prevention therapies are specifically prescribed to the patient by the physician, and the DVTherapy unit must be programmed to the specific therapy (See Section 9.5 DVTherapy

Programming). No changes may be made to the therapy without reprogramming the DVTherapy. For all DVT prevention therapies run on the DVTherapy, the standard pressure set points are 50 mmHg for the calf, and 120 mmHg for the foot. The types of DVT prevention therapy include:

• Foot single (DVT Foot) • Foot bilateral (DVT Foot L&R) • Calf single (DVT Calf) • Calf bilateral (DVT Calf L&R)

• Foot and Calf (AI) single (DVT Foot & Calf) • Foot and Calf (AI) bilateral (DVT Foot & Calf L&R)

Select Therapy

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10. Operating Instructions (Continued)

DVT prevention therapies inflate the particular limb wrap (foot or calf) to the preset pressure, and once the pressure is reached, the pressure is immediately released. The therapy is run on a 60 second

repeating cycle, with the left and right limbs alternating inflation cycles every 30 seconds (in the case of a single limb, the limb is cycled once every 60 seconds).

DVT Foot and Calf (AI) therapies inflate the foot wrap to the pressure setpoint, holds the foot pressure, inflates the calf to the pressure setpoint, and after a brief hold period sequentially deflates the foot wrap and the calf wrap. The therapy is run on a 40 second cycle, alternating between each limb every 20 seconds (in the case of a single limb, the limb is cycled once every 20 seconds)

If there is any question to the type of DVT prevention therapy that should be running on the DVTherapy, contact the health care provider responsible for prescribing the therapy.

DVT prevention therapy may be run on the Recovery+ simultaneously with Heat, Cool, or Alternating therapy, as well as with Compression therapy.

1. If the DVTherapy is not installed into the Recovery+, insert the DVTherapy into the Recovery+ as described in Section 8 Setup Instructions.

When initially inserting the DVTherapy into the Recovery+, a message “DVTherapy Not Ready” will briefly be displayed on the Recovery+ display window while the DVTherapy establishes communication. DVT prevention therapy will momentarily be unavailable during this time.

2. Press the DVT key to start the DVT prevention therapy. The display will change to display the type of DVT prevention therapy and run the therapy.

The DVT prevention therapy is programmed on the DVTherapy unit. The therapy cannot be changed without reprogramming the unit (See Section 9.5 DVTherapy Programming).

3. The type of DVT prevention therapy may differ based on the prescribed therapy for the

patient.

4.

After the prescribed duration of therapy has completed, press the DVT key to stop the DVT prevention therapy.

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45°F / 050 mmHg

10. Operating Instructions (Continued)

Real-Time Display of Temperature and Pressure

At any time during Cool, Heat, Alternating therapies, either the HEAT or COOL key may be pressed momentarily to display the current real-time temperature of the liquid leaving the Recovery+ unit. If Pneumatic Compression therapy is active, the real-time wrap pressure will also be displayed if either the HEAT or COOL key is pressed.

Note: momentarily pressing the HEAT or COOL keys will not stop the current thermal therapy. In order to stop the therapy, the HEAT or COOL key must be pressed and held down for 2 seconds.

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61

10. Operating Instructions (Continued)

10.3 DVTherapy Operating Instructions

Follow the Setup Instructions in Chapter 8.2 prior to operating the DVTherapy

2. After a brief boot-up sequence the display will read “Press RUN to Start”

3. The DVTherapy is now ready for use.

Any anytime the unit is on, the DVTherapy may be shut off by pressing and holding the power key for 2 seconds. Shutting off the DVTherapy will stop any therapy that may currently be running.

DVT Prevention Therapy (DVTherapy Standalone)

DVT prevention therapy is used in combination with specially designed therapy wraps to transfer pressure to either the foot or calf using compressed air.

The DVT prevention therapies are specifically prescribed to the patient by the physician, and the DVTherapy unit must be programmed to the specific therapy (See Section 9.5 DVTherapy

Programming). No changes may be made to the therapy without reprogramming the DVTherapy. For all DVT prevention therapies run on the DVTherapy, the standard pressure set points are 50 mmHg for the calf, and 120 mmHg for the foot. The types of DVT prevention therapy include:

• Foot single (DVT Foot) • Foot bilateral (DVT Foot L&R) • Calf single (DVT Calf) • Calf bilateral (DVT Calf L&R)

• Foot and Calf (AI) single (DVT Foot & Calf) • Foot and Calf (AI) bilateral (DVT Foot & Calf L&R)

Press RUN To Start

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DVT Foot Bilateral

10. Operating Instructions (Continued)

DVT prevention therapies inflate the particular limb wrap (foot or calf) to the preset pressure, and once the pressure is reached, the pressure is immediately released. The therapy is run on a 60 second

repeating cycle, with the left and right limbs alternating inflation cycles every 30 seconds (in the case of a single limb, the limb is cycled once every 60 seconds).

DVT Foot and Calf (AI) therapies inflate the foot wrap to the pressure setpoint, holds the foot pressure, inflates the calf to the pressure setpoint, and after a brief hold period sequentially deflates the foot wrap and the calf wrap. The therapy is run on a 40 second cycle, alternating between each limb every 20 seconds (in the case of a single limb, the limb is cycled once every 20 seconds)

If there is any question to the type of DVT prevention therapy that should by running on the DVTherapy contact the health care provider responsible for prescribing the therapy.

The DVT prevention therapy is programmed on the DVTherapy unit. The therapy cannot be changed without reprogramming the unit (See Section 9.5 DVTherapy Programming).

1. Press the RUN key to start the DVT prevention therapy. The display will change to display the type of DVT prevention therapy and run the therapy.

2. The type of DVT prevention therapy may differ based on the prescribed therapy for the

patient.

5. After the prescribed duration of therapy has completed, press the Run key to stop the DVT prevention therapy.

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14. Storage and Transportation

WARNING

: Do not operate units in a wet environment.

• Disconnect all fittings prior to storage or transportation of the units.

• Drain water from the Recovery+ prior to storage or transportation. See Draining the Fluid from

Recovery+

• Ensure the Recovery+ is standing upright when stored or transported

• Store in a dry location between 10° C (50° F) and 40°C (105° F), 30% - 70% relative humidity. • Do not expose the units to a direct heat source with temperatures exceeding 50° C (122° F) for

extended periods of time when storing or transporting.

• Do not store items in direct sunlight when storing or transporting.

Storage Conditions

• Temperature Range: 10° C (50° F) and 40°C (105° F) • Relative Humidity: 30% to 70%

Transport Conditions

• Temperature Range: -20°C (-4°F) to 60°C (140°F) • Relative Humidity: 30% to 70%

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72

15. Troubleshooting

15.1 General Troubleshooting

The following table provides general troubleshooting steps. For more detailed troubleshooting information on system faults, see Section 15.2 Faults.

Problem Solution

Recovery+ will not turn on Make sure the power cord is plugged in and the main power switch is turned on

DVTherapy will not turn on Battery charge is low. Plug unit into the DVTherapy power supply or install into the Recovery+ to continue use.

Allow the DVTherapy to charge 3-8 hours before using on battery power.

Recovery+ or DVTherapy wraps will not

inflate or are slow to inflate. Check to insure wraps are fully connected to the proper fittings on the unit. Check for kinks in the wrap hose, and straighten hose.

Pressure on Recovery+ or DVTherapy wraps feel too high or is causing pain

Stop therapy and contact physician immediately if pain is resulting from therapy.

Water temperature in the Recovery+ wrap is not being Heated or Cooled

Check that wrap is fully connected to the proper fittings on the Recovery+

Check for kinks in the wrap hose, and straighten hose.

Verify that the proper therapy is currently running - Contact Physician

The Recovery+ has a maximum continuous cooling time of 2 hours. After 2 hours, the Recovery+ will suspend cooling for 30 minutes. When the 30 minute suspension is up, cooling will automatically resume. The cooling suspension may be

overridden by stopping and restarting Cool therapy. Water temperature in Recovery+ wrap

is too cold Adjust the temperature up. Stop therapy and contact physician immediately if pain is resulting from therapy.

Water temperature in Recovery+ wrap

is too Hot Stop therapy and contact physician immediately if pain is resulting from therapy.

"Check Wrap, Check Water Level" is

displayed on the Recovery+ screen Check that wrap is fully connected to the proper fittings on the Recovery+ Check for kinks in the wrap hose, and straighten hose.

Check liquid level in reservoir. Add liquid if below Min line.

Run the therapy for several minutes with the cap removed from the reservoir to allow any air that may have become trapped to escape from the system.

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15. Troubleshooting (continued)

Problem Solution

A “Check Wrap” message is displayed on the Recovery+ or DVTherapy

Check to insure wraps are fully connected to the proper fittings on the unit.

Check for kinks in the wrap hose, and straighten hose.

Ensure wraps have been properly applied, and that they are not secured loosely or overly tight

The Recovery+ shuts off without any

display message Verify that power cord is still plugged in and that main power switch is turned on. The DVTherapy shuts itself off If left idle and not running a therapy while on battery

power, the DVTherapy will automatically turn itself off to conserve the battery.

The DVT key on the Recovery+ does

not start DVT therapy Ensure that the DVTherapy unit is fully inserted into the Recovery+ "Call for Service" message is displayed

on either the Recovery+ or the DVTherapy

Contact Customer Support

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74

15. Troubleshooting (continued)

15.1 Faults

The Recovery+ and DVTherapy each diagnose system malfunctions when a mechanical or system fault occurs. The equipment typically reports thee faults by displaying a message on the display screen that provides general instructions on how to address the fault, along with a fault code (some faults

automatically shut the equipment off and, therefore, will display no message to the screen). All occurrences of faults codes are recorded to the SD card to the file “LOG.txt”. This file may be needed to properly troubleshoot a problem with the equipment. Contact Pulsar Scientific for more information.

If a fault does occur, follow the on screen instructions accompanying the fault message, and then shut the equipment off and turn back on again to clear the fault. All faults require that the equipment be turned off and then back on in order to clear the fault and allow further operation of the unit.

If the fault message provides instructions to “Call for Service”, contact the equipment provider or Pulsar Scientific. Do not attempt to service the equipment.

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15. Troubleshooting (continued)

15.2 Recovery+ Faults Fault Code

(Logged in LOG.txt) Display Message Reason for fault Possible causes

Operator and Patient Troubleshooting 2010 Call for Service

(2010)

Air pump current high (when pump is on)

▪ Seized air pump ▪ Failed air pump

▪ Call Service

2011 Call for Service (2011)

Air pump current low ▪ Air pump disconnected ▪ Wire harness issue ▪ Failed air pump

▪ Call Service

Air pump current high (when pump is off)

▪ Control board fault ▪ Call Service

2013 Check Wrap (2013) Check Air Connection

Pressure setpoint exceeded ▪ Wrap over compressed during inflation ▪ Runaway air pump (electrical malfunction)

▪ May occur if wrap squeezed or sat on during inflation.

▪ Shut unit off and turn back on to clear fault.

▪ Call service if fault continues to occur

Water pump current high (when pump is on)

▪ Seized water pump ▪ Failed water pump

▪ Call Service

Water pump current low ▪ Water pump disconnected ▪ Wire harness issue ▪ Failed water pump

▪ Call Service

Water pump current high (when pump is off)

Heatsink Temperature High ▪ Unit airflow is blocked ▪ Check for obstructions at front air intake of unit.

▪ Clean air filter if filter is clogged. ▪ Shut unit off and turn back on to clear fault.

Heat Exchanger Temperature High ▪ Runaway heating (Electrical malfunction) ▪ Call Service

Heat Exchanger Temperature Low ▪ Runaway cooling (Electrical malfunction) ▪ Call Service

Sensor Block Temperature Low ▪ Runaway cooling (Electrical malfunction) ▪ Call Service

2036 No display message (unit is shut off)

Heatsink Temperature High and software unable to turn off power to heating/cooling system

▪ Runaway heating (Electrical malfunction) ▪ Call Service

Heat Exchanger Temperature High and software unable to turn off power to heating/cooling system

▪ Runaway heating (Electrical malfunction) ▪ Call Service

Heat Exchanger Temperature Low and software unable to turn off power to heating/cooling system

▪ Runaway cooling (Electrical malfunction) ▪ Call Service

Sensor Block Temperature Low and software unable to turn off power to heating/cooling system

▪ Runaway cooling (Electrical malfunction) ▪ Call Service

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76

15. Troubleshooting (continued)

Unexpected loss of 24V to control board

▪ Switched off unit or unplugged ▪ Hardware monitored sensor block temperature too high or too low ▪ Power supply failure

▪ This fault will be generated if main power switch on back of Recovery+ is turned off, or if the unit is unplugged from the wall without first shutting off the unit from the keypad.

▪ A power fluctuation (black out, brownout) in the home or facility electrical system may cause this fault. ▪ Shut unit off and turn back on to clear fault.

▪ Call service if fault continues to occur.

Pressure set point not reached within time limit

▪ Wrap not connected ▪ Wrap not applied correctly ▪ Air leak in wrap or line ▪ Air leak within equipment

▪ Check if wrap is fully connected to the Recovery+ and extension hose. ▪ Shut unit off and turn back on to clear fault.

Pressure set point reached too quickly

▪ Pinched wrap line

▪ Restriction within wrap or air line ▪ Air restriction within equipment

▪ Check for pinched air line. ▪ Shut unit off and turn back on to clear fault.

2060 Check Wrap

Check Water Level

Heat Exchanger continues to cool, but no change occurs in outlet water temperature

▪ Low liquid level in reservoir ▪ Wrap not connected ▪ Pinched wrap line

▪ Low water flow rate (internal restriction) ▪ System is air locked/air bubble trapped in system

▪ Check liquid level in reservoir. ▪ Checked for pinched wrap lines. ▪ Check if wrap is fully connected to Recovery+ and extension hose. ▪ If unit was recently filled with water or an empty wrap was recently connected, allow unit to run several minutes in heating or cooling with reservoir cap removed to help release air bubbles from system.

2061 Check Wrap

Check Water Level

Heat Exchanger continues to heat, but no change in occurs outlet water temperature.

▪ Low liquid level in reservoir ▪ Wrap not connected ▪ Pinched wrap line

▪ Low water flow rate (internal restriction) ▪ System is air locked/air bubble trapped in system

▪ Check liquid level in reservoir. ▪ Checked for pinched wrap lines. ▪ Check if wrap is fully connected to Recovery+ and extension hose. ▪ If unit was recently filled with water or an empty wrap was recently connected, allow unit to run several minutes in heating or cooling with reservoir cap removed to help release air bubbles from system.

2090 No Display (unit is shut off)

WatchDog Interrupt This is a special fault that is logged in LOG.text when the Power key is held for 10 seconds. This 10 second key press is used to force a reboot in case the unit has locked up due to a hardware or software fault and does not respond to normal key presses.

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15. Troubleshooting (continued)

15.3 DVTherapy Faults Fault Code

(Logged in LOG.txt) Display Message Reason for fault Possible causes

Operator and Patient Troubleshooting 1010 Call for Service

(1010)

Air pump current high (when pump is on)

▪ Seized air pump ▪ Failed air pump

▪ Call Service

Air pump current low ▪ Air pump disconnected ▪ Wire harness issue ▪ Failed air pump

▪ Call Service

Air pump current high (when pump is off)

1013 Check [port ID** ] Wrap and Air Line (1013)

Pressure setpoint exceeded ▪ Wrap over compressed during inflation ▪ Runaway air pump (electrical malfunction)

▪ May occur if wrap squeezed or sat on during inflation.

Failure to load therapy file ▪ Therapy file not loaded in software ▪ Call Service

Pressure set point not reached within time limit

▪ Wrap not connected ▪ Wrap not applied correctly ▪ Air leak within equipment ▪ Air leak in wrap or line

▪ Check if wrap is fully connected to the DVTherapy.

Pressure set point reached too quickly

▪ Pinched wrap line

▪ Restriction within wrap or air line ▪ Air restriction within equipment

▪ Check for pinched wrap air lines. ▪ Shut unit off and turn back on to clear fault.

1080 Low Battery Low battery charge ▪ Battery charge is low ▪ Failed battery

▪ Plug DVTherapy into power supply or insert into Recovery+ to charge. ▪ Allow unit to fully charge before running on battery power. ▪ Shut unit off and turn back on to clear fault.

▪ Call service if fault continues to occur after battery has fully charged.

1090 No Display (unit is shut off)

WatchDog Interrupt This is a special fault that is logged in LOG.text when the Power key is held for 10 seconds. This 10 second key press is used to force a reboot in case the unit has locked up due to a hardware or software fault and does not respond to normal key presses.

▪ Call Service

**port ID: port inflation was taking place on when fault detected e.g.: "Check Foot Left Wrap

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16 Technical

Information

16.1 Device Specifications Recovery+ Specifications

Model Name Recovery+

Model Number PS511

Electrical Classification Class I Mobility Classification Portable

Applied Part Type B Applied Part

Mode of Operation Continuous Operation

Protection Against

Ingress of Water IPXO

AP/APG Category Not suitable for use in the presence of a flammable anesthetic mixture with air or oxygen or nitrous oxide

Cooling /Heating System Thermoelectric Modules (TECs), 8 Total

Two Groups of 4 TECs (TEC group 1, TEC group 2) 24 VDC each pair (series parallel)

Heat Temperature 105°F (fixed)

Cooling Temperature 43°F to 50°F (adjustable)

Pneumatic Compression 15 mmHg, 50 mmHg, or 75 mmHg (each setpoint fixed, setpoint selectable) Water Pump Capacity 0.2 gm/min @ 6 VDC – 0.7 A (12V rated running at 6V)

Air Pump Capacity 4.5 liter/min @ 6 VDC – 0.5 A (6V rated) Reservoir Capacity 0.2 liter to fill line, 0.4 liter full capacity

Water Flow Rate 0.17 GPM

Air and Water Connections (3) connections: (2) water (supply, return); (1) air

Size 6.04”W x 15.72”L x 12.28”H

Weight 19 lbs

Supply Voltage 115V VAC; 60 Hz

Fuse 250VAC, 8A, Slow Blow, 5mmx20mm

Operating Temperature 50°F to 105°F

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16. Technical

Information (Continued)

DVTherapy Specifications

Model Name DVTherapy

Model Number PS511A

Electrical Classification Internally Powered (Rechargeable battery);

May be connected to an external 12 VDC power supply for power and charging battery: Elpac Power Systems MW2412-760-NC-(BK, WH) Mobility Classification Portable

Applied Part Type BF Applied Part

Mode of Operation Continuous Operation

Protection Against

Ingress of Water IPXO

AP/APG Category Not suitable for use in the presence of a flammable anesthetic mixture with air or oxygen or nitrous oxide

Pneumatic Compression Foot: 120 mmHg (fixed) Calf: 50 mmHg (fixed)

Air Pump Capacity 4.5 liter/min @ 6 VDC – 0.5 A (6V rated)

Air Connections (4) connections

Battery 6V, 2600 mAh NiMH (5x A cells)

Battery Runtime between

Recharges 15-17 Hours

Recharge Time 3-8 hrs

Supply Voltage (to external

power supply) 115 VAC (100-240VAC 50/60 Hz rated wall transformer)

Operating Temperature 50°F to 105°F

Operating Humidity 30% to 70% relative, non-condensing

Size 4.32”W x 5.67”L x 2.50”H

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16. Technical

Information (Continued)

16.2 Equipment Symbols and Markings

Refer to operating manual for further instructions

This symbol designates the degree of protection against electric shock as being

a Type B applied part.

This symbol designates the degree of protection against electric shock as being

a Type BF applied part.

AC

Alternating current

DC

Direct current

Hz

Hertz

W

Watts

8A-SB

Designation of the fuse used in the Recovery+.

8 Amperes (8A), Slow Blow (SB) type fuse.

WARNING

: Do not attempt to service internal components. Contact Customer Service.

Min

Indicator for minimum amount of liquid required within the Recovery+

reservoir.

Max

Indicator for maximum amount of liquid that should be added to the

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16. Technical

Information (Continued)

16.3 DVTherapy Rechargeable Battery

The DVTherapy uses as internal, rechargeable battery for power when not assembled to the Recovery+ or the DVTherapy external power supply.

Note: The rechargeable battery is not replaceable. Return the DVTherapy to Pulsar Scientific for service.

Battery Specifications:

Battery Type: NiMH

Recharge time: 3-8 Hours

Expected Run Time: 15-17 hours

Approximate number of

charges before replacement: 500

16.4 DVTherapy External Power Supply

The DVTherapy may be powered and run directly off its external power supply. The external power supply will recharge the battery while connected to the DVTherapy.

External Power Supply Specifications

Model: Elpac MW2412-760-NC- (BK, WH)

Power supply color may be either black (BK) or White (WH) Input: 100-240 VAC, 47-63 Hz, 0.43A (@115 VAC)

Output: +12 VDC, 2.0 A, 24W

WARNING

: Only operate DVTherapy with the external power supply provided – do not

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82

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Recovery+ and DVTherapy Operator s Manual. Models PS511 (Recovery+) and PS511A (DVTherapy)