www.ottobockus.com
`
`Authorized Representative and Distributor
`Otto Bock HealthCare GmbH
`Max-Näder-Str.15
`D-37115 Duderstadt, Germany
`Phone +49 (0) 5527-8480 • Fax +49 (0) 5527-72330
`
`Manufactured by:
`Otto Bock HealthCare of the Americas
`Two Carlson Parkway North, Suite 100
`Minneapolis, MN 55447 USA
`Phone 800.328.4058 • Fax 800.962.2549
`U.S. Patent No. 6,645,253
`
`Harmony, Loctite and MOBIS are registered trademarks of Otto Bock HealthCare LP.
`©2005 Otto Bock HealthCare LP. • Printed in the USA. • SL=2900-4005 • 04020441.1D 9/05
`
`Page 1
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`Össur Ex. 1025
`Petition for Inter Partes Review
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`4R133, 4R134, 4R135, 4R144, 4R150
`
`Instructions for Use
`Bedienungsanleitung
`Instructions d’utilisation
`Istruzioni per l'uso
`Instrucciones de uso
`Bruksanvisning
`Instruções de Utilização
`Gebruiksaanwijzing
`√‰ËÁ›Â˜ ÃÚ‹Û˘
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`D F I E S P N
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`J
`CHI
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`9' 0CR
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`1
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`5
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`2
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`6
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`Position 1
`Position 1 \
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`Position 2
`Position 2
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`-
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`~
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`9
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`10
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`Harmony • Instructions for Use
`
`Table of Contents
`
`1.0 Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
`
`1.1 Safety Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
`
`1.2 Patient Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
`
`2.0 Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
`
`2.1 Replacement Parts and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
`
`3.0 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
`
`4.0 Installing the Harmony 4R134, 4R135, 4R144 and 4R150. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
`
`4.1 Installing the Barbed Socket Connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
`
`4.2 Attaching Socket and Adapter to Harmony . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
`
`4.3 Attaching Pylon to Harmony . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
`
`4.4 Connecting the Vacuum Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
`
`5.0 Installing the Harmony 4R133 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
`
`6.0 Adjusting the Harmony 4R144 and 4R150 Elastomer Rod Shock Absorber . . . . . . . . . . . . . . . . . . . . . . . . . 5
`
`7.0 Adjusting the Air Shock in the 4R133, 4R134, 4R135.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
`
`8.0 Monitoring the Elevated Vacuum Environment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
`
`8.1 Verifying the System if Vacuum Loss Occurs & Flow Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
`
`9.0 Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
`
`10.0 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
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`
`Harmony • Instructions for Use
`
`1.0 Application
`The Harmony Pump is a component of the Harmony Elevated Vacuum System, which also includes a Total Surface
`Weight Bearing Socket, Polyurethane Liner, Air Wick, and Sealing Sleeve. The Harmony is to be used solely for the
`prosthetic fitting of the lower limbs.
`For Patient Weights of 50 to 100 kg. (110 to 220 lbs.)
`• Harmony 4R133 Pump for use in some prosthetic feet (Fig. 5)
`• Harmony 4R134 34mm Tube Clamp Adapter (Fig. 3)
`• Harmony 4R135 Female Pyramid Receiver Adapter (Fig. 4)
`• Harmony 4R144 Integrated Male Pyramid Connector and 30 mm Distal Tube Clamp Adapter (Fig. 1)
`For Patient Weights of 100 to 150 kg. (220 – 330 lb.s)
`• Harmony 4R150 Female Pyramid Receiver Adapter (Fig. 2)
`
`1.1 Safety Considerations
`• The Harmony Pump should be examined for proper function during routine check-ups by qualified personnel.
`• The Harmony Pump may only be opened and repaired by an authorized Otto Bock Technician.
`• The patient should be properly instructed in the use of the Harmony Pump and Harmony System as outlined
`in the Patient Information Section.
`
`1.2 Patient Information
`• Handle the Harmony Pump carefully and examine often for any signs of damage.
`• Work with your prosthetist to make sure you understand how the Harmony System feels when functioning
`properly, when loss of vacuum occurs, and what the overall effects of applying an elevated vacuum to
`the limb.
`• Read section 8.0 of this manual to understand how to perform basic system checks in case of loss of
`the vacuum.
`
`IMPORTANT: Proper maintenance and care require flushing 1 to 2 ounces of distilled water (about 5 to 10 pumps)
`through the Harmony® system after contact with salt water or perspiration.
`
`2.0 Components
`The Harmony 4R144 and 4R150 pumps are delivered with the following components
`1. Harmony Pump
`2. Vacuum Gauge Assembly
`3. Vacuum Line, Neoprene Boot, (2) Tube Collars and (1) Straight- and (1) 90˚-Barbed Stainless Steel Socket
`Connectors
`4. Instructions for Use SL=2900-4005
`The Harmony 4R133, 4R134, 4R135 pumps are delivered with the following Components
`1. Harmony Pump
`2. Hand Pump
`3. Tube Collar and (1) Straight- and (1) 90˚-Barbed Stainless Steel Socket Connectors
`4. Instructions for Use SL=2900-4005
`
`2
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`Harmony • Instructions for Use
`
`2.1 Replacement Parts and Accessories
`Harmony components can be ordered individually from Otto Bock using the following information.
`Pc.
`Description
`Otto Bock TEC Part No.
`1
`Air Spring Pump Kit (for all units) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Y352
`1
`Vacuum Line, 5 feet (for all units) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Y309
`10pk
`Tube Collars (for all units) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Y310
`1
`Tube Clamp Bar (for 4R134) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Y323
`1
`Tube Clamp Screw, M5 x 22 Grade 12.9 (for 4R144) . . . . . . . . . . . . . . . . . . . . . . . 501Z2=M5X22
`1
`34-30 mm reducing Split spacer (for 4R134). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Y324
`1
`Valve Kit (for 4R134, 4R135) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4R138=5
`5pk
`Valve Kit, rubber air valves (for 4R144, 4R150) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Y351-5
`1
`Elastomer Rod, 90 shore A, yellow (for 4R150) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Y348
`1
`Elastomer Rod, 80 shore A red (for 4R144). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Y347
`1
`Intake Valve with screen (for 4R144, 4R150) (Fig. 1, Pos.1) . . . . . . . . . . . . . . . . . . . . . . . . . 4Y346
`1
`Expulsion Valve (for 4R144, 4R150) (Fig.1, Pos.2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Y345
`1
`1/8˝ Barbed Socket Connector/Filter (all units) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Y344
`1
`1/8˝ Barbed Socket Connector 90˚ Elbow Connector/Filter (all units) . . . . . . . . . . . . . . . . . . . 4Y350
`3pk
`Harmony Protective Boot (for 4R144, 4R150) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Y319=3
`3pk
`Harmony Protective Boot (for 4R134, 4R135) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Y319
`3pk
`Harmony Protective Boot (for 4R133) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Y320
`1
`Harmony Complete Installation Kit (4R133, 4R134, 4R135) . . . . . . . . . . . . . . . . . . . . . . . . . . 4R130
`1
`Harmony Testing Kit, 4R133, 4R134, 4R135 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4R131
`1
`Harmony 4R144, 4R150 Service Kit
`3.0 Description
`The Otto Bock Harmony Pump combines the function of a vacuum pump and the function of a damping shock
`absorber in one unit. The 4R144 and 4R150 include the additional features of axial rotation and torsional shock
`absorption.
`Function of the Vacuum Pump
`The Harmony Pump is designed to generate an elevated vacuum to increase the linkage between user and
`prosthesis, and requires a sealed environment between the user’s leg/liner, the socket, and the sealing sleeve.
`Once the environment is sealed, the Harmony Pump, which is compressed and released during normal walking,
`draws air from the socket through one-way valves and evacuates it through the pump. After multiple cycles of
`compression an elevated vacuum of 15-25 in. Hg. (508-847 millibars) is created in the sealed socket environment.
`The Harmony Elevated Vacuum Socket System:
`• Improves fluid exchange in the residual limb and helps to control daily volume fluctuations
`• Increases proprioception
`• Increases suspension to improve gait and overall function
`• Reduces forces to the residual limb and liner
`• Reduces moisture buildup on the residual limb
`Function of the Shock Absorber
`The Harmony shock absorption functions helps to reduce vertical and torsional forces in the extremities during
`walking. The result is an improvement for both the function and loading situation of the prosthesis wearer.
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`Harmony • Instructions for Use
`
`Vertical and Rotational Shock Absorption in the 4R144 and 4R150
`Vertical shock absorption can be adjusted by the prosthetist by increasing or decreasing the compression of the
`elastomer rod. Rotational shock absorption is made possible by elastomer plates, which are not field serviceable.
`Vertical Shock Absorption in the 4R133, 4R134 and 4R135 can be adjusted by increasing or decreasing the
`amount of air pressure in the unit.
`4.0 Installing the Harmony 4R134, 4R135, 4R144 and 4R150
`Note: Failure to use the Harmony with a properly fitting Harmony socket system can compromise the limb, liner,
`and the Harmony pump.
`
`4.1 Installing the Barbed Socket Connector
`Note: To fabricate an airtight, laminated socket, blister-form a 3 mm PETG plastic sheet (575=1) as the first layer
`in the definitive socket lay-up.
`To ensure an airtight system you must create an airtight channel between the Barbed Socket Connector and the
`interior of the socket. We recommend the following technique.
`Prepare a channel in the socket by drilling a 3/8” (10 mm) hole in either the distal end or the posterior socket wall.
`Fill with five minute epoxy. Once epoxy has hardened, drill a 7/32 (5.5 mm) hole through the middle of the epoxy
`(Fig. 6). Use the Barbed Socket Connector to tap the hole, then remove and apply 5 minute epoxy to the threads,
`reinsert and hand tighten.
`
`4.2 Attaching Socket and Adapter to Harmony
`Pyramid Adapter style: Harmony 4R144
`Tighten the set screws of the receiver onto pyramid and torque to 15NM (or to the manufacturer’s specification if
`not an Otto Bock component). Use Loctite® 242 on screws for final adjustment.
`4-Bolt Pattern Style: Harmony 4R134, 4R135 and 4R150
`The Harmony 4R134, 4R135 and 4R150 pumps have a 4-bolt pattern on top for connecting the appropriate male
`or female adapters to the socket (i.e. 4R77, 4R23 or 4R51). Use the provided Cap Head Screws and connect the
`adapter to the Harmony. For final adjustment, apply Loctite® 242 to screws and torque to 115 in−lbs (13NM).
`
`4.3 Attaching Pylon to Harmony
`30mm Tube Clamp (4R144): Insert the 2R2 pylon into tube completely. Torque the tube clamp screw to 88 in-lbs
`(10 Nm) for the final adjustment.
`Female Pyramid Receiver Style (4R135 and 4R150): Tighten the set screws of the pyramid receiver onto the
`attachment and torque to 133 in-lbs (15Nm.). Use Loctite® 242 on screws for final adjustment.
`34mm Tube Clamp (4R134): Insert 2R76 pylon into tube clamp completely. Torque the tube clamp screw to 44
`in-lbs (5 Nm) for the final adjustment.
`
`4.4 Connecting the Vacuum Line
`To connect the Vacuum Line to the socket, cut line to length proximally, moisten end of line, slide Retention Collar
`over Line, attach Line to Barbed Socket Connector, and slide Retention Collar into place (Fig. 7).
`5.0 Installing the Harmony 4R133
`5.1 To remove original shock, remove the cap head screw from the housing of the foot with a 4mm Allen wrench.
`5.2 Push the pin through the shock and remove shock.
`5.3 Repeat steps 5.1 and 5.2 for the other end of the shock.
`5.4 Remove the original shock from the housing of the foot.
`5.5 Remove the washers from the original shock.
`4
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`Harmony • Instructions for Use
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`5.6 Remove the bushings from the original shock and insert bushings in the Harmony 4R133.
`5.7 Re-use the original washers on the proximal end of the Harmony 4R133.
`5.8 Place provided washers supplied with Harmony 4R133 on both sides of the distal bushings.
`5.9 Install the Harmony 4R133 in the foot housing.
`5.10 Push the pins through the bushings.
`5.11 Reinstall the cap head screws in the pin and tighten with a 4 mm Allen wrench.
`5.12 To connect the Vacuum Line to the socket, see section 4.4.
`6.0 Adjusting the Harmony 4R144 and 4R150 Elastomer Rod Shock Absorber —
`PRACTITIONERS ONLY
`The preload on the elastomer rod in these units can be adjusted to accommodate different patient weights. This
`function should be adjusted for the patient’s normal gait. In order for the vacuum pump to function properly, the
`Harmony 4R144 and 4R150 must be adjusted so that the shaft extends completely when unweighted (with no air
`pressure in the air chamber), and so that it compresses between 5 and 7 mm when weighted.
`To replace the Elastomer Rod:
`1. Locate Blue Cup inside shaft (Fig. 8). Screw in completely using a 3/8” (10mm) Allen wrench
`2. To set Elastomer Rod tension, release pressure on the Rod by backing out the Blue Cup. See suggested
`starting points below. Because the resistance of the elastomer rods can change slightly over time, we
`recommend it be readjusted during routine checkups.
`4R144 only (Red Elastomer Rod)
`Patient Weight (lbs / kgs)
`# of turns out (counterclockwise) from fully inset position
`120 lb. / 50kg. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.5
`140 lb. / 60 kg. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.0
`160 lb. / 70 kg. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.5
`180 lb. / 80 kg. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.0
`200 lb. / 90 kg. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.5
`220 lb. / 100 kg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.0
`4R150 only (Yellow Elastomer Rod)
`Patient Weight (lbs / kgs)
`# of turns out (counterclockwise) from fully inset position
`220 lb. / 100kg. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.5
`240 lb. / 110 kg. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.0
`260 lb. / 120 kg. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.5
`280 lb. / 130 kg. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.0
`300 lb. / 140 kg. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.5
`320 lb. / 150 kg. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.0
`
`Important: Do not unscrew more than 5 turns, as this may prevent the shaft from extending completely and
`compromise the vacuum pump function.
`
`7.0 Adjusting the Air Shock in the 4R133, 4R134, 4R135 — USERS AND PRACTITIONERS
`Resistance in the Air Shock can be modified with a hand pump when high-level activities are encountered (Fig. 9).
`Please be aware that increased resistance in the Air Shock may limit the travel of the pump piston, requiring more
`compression cycles for you to attain the desired elevated vacuum during normal walking.
`Note: When adjusting pressure in the Air Shock, we recommend that you begin at 0 psi as a starting point. Please
`see section 9.0 for recommended air pressure.
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`Harmony • Instructions for Use
`
`8.0 Monitoring the Elevated Vacuum Environment
`A Vacuum Gauge Assembly is included with the 4R144 and 4R150 Pumps.
`We recommend purchasing the 4R130 Harmony Complete Installation Kit, or the 4R131 Harmony Testing Kit for
`monitoring and repair needs for the 4R133, 4R134, 4R135 units.
`To verify that the Harmony System can maintain an elevated vacuum environment, it is necessary to temporarily
`install a vacuum gauge. To do this, remove the Vacuum Line from the Harmony Intake Valve (Fig. 10). Next, take
`the Vacuum Gauge Assembly and attach the Vacuum Line (short side) to the Inlet Valve (Fig.1, Pos. 1) and
`connect the socket-side Vacuum Line to the open barb on Vacuum Gauge Assembly (Fig.11).
`While the patient is standing and wearing the properly fitting Harmony System, cycle the Harmony Pump to
`generate a vacuum between 15-25 in. Hg. (508-847 millibars). Stop cycling the pump and verify that the vacuum is
`maintained when it is not being cycled. If the vacuum is maintained, the system is functioning correctly. If vacuum
`loss does occur, it will be necessary to check the system as shown in Section 8.1.
`
`8.1 Verifying the System if Vacuum Loss Occurs – See Flow-Chart
`To determine if the vacuum loss exists in Zone 1, 2 or 3 (Fig. 12) install gauge as described in section 8.0 (Fig. 11).
`Cover the hole on the inside of the socket with a piece of tape that is not air-permeable (such as PVC tape). Cycle
`the pump to reach 15-25 in. Hg. (508-847 millibars). Check to see if vacuum level is maintained when the pump is
`not being cycled.
`
`Continue to the Flow-Chart
`
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`Harmony • Instructions for Use
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`FLOW CHART
`
`Vacuum maintained
`means Zone 2 and 3 are OK
`
`Vacuum NOT maintained
`
`Examine Zone 1 (socket and sleeve)
`for any leaks or damage.
`
`Problem exists in Zone 2 or Zone 3
`
`With T-Connector removed, attach gauge directly to socket side of intake valve (Fig.13) and cycle pump until 15-25 in.
`Hg. (508-847 millibars) is reached. Determine if vacuum level is maintained when the pump is not being cycled.
`
`Vacuum maintained means Zone 3 is OK
`
`Vacuum NOT maintained
`
`Intake valve is OK. Problem is probably in Zone 2
`(barbed fitting on socket, line, or channel in socket).
`Examine for leaks or damage.
`
`Problem exists in intake Valve, line to Harmony pump, or in
`Harmony Pump.
`
`Exchange Intake Valve and check again.
`
`Vacuum maintained. Replace valve.
`
`Vacuum NOT maintained
`
`Replace Tubing and test again by cycling pump until 15-25 in. Hg. (508-847 millibars) is reached. Determine if vacuum
`level is maintained when the pump is not being cycled.
`
`Vacuum maintained. Replace tubing.
`
`Vacuum NOT maintained
`
`Problem with Harmony Pump. Please call Otto Bock support Staff.
`
`Note: To clean the Barbed Socket Connector: Disconnect the tubing from the Barbed Socket Connector and gently
`blow air through the fitting back into the socket.
`
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`Harmony • Instructions for Use
`
`9.0 Technical Data
`Harmony-4R133
`Weight: .68 lbs/309 grams
`Weight Limit: 220 lbs/100 kgs
`Air spring operating psi: 40-120 psi/1.35-4.06 bar
`Material: Aluminum
`Harmony-4R134
`Weight: 1.6 lbs/726 grams
`Height: 5 1⁄8 in/130 mm
`Diameter: 3.2 in/81mm
`Weight Range: 110-220 lbs/50-100 kgs
`Air spring operating psi: 0-20 psi/0-.68 bar
`Tube clamp screw: 44 in/lbs (5 Nm)
`Adapter 4-Hole pattern: 120 in/lbs (13 Nm)
`Material: Aluminum/Titanium
`Harmony-4R135
`Weight: 1.6 lbs/726 grams
`Height: 4 5⁄8 in/117 mm
`Diameter: 3.2 in/81mm
`Weight Range: 110-220 lbs/50-100 kgs
`Air spring operating psi: 0-20 psi/0-.68 bar
`Receiver Set Screw Torque: 133 in/lbs (15 Nm)
`Adapter 4-Hole pattern: 120 in/lbs (13 Nm)
`Material: Aluminum/Titanium
`Harmony-4R144
`Weight: 1.1 lbs/520 grams
`Height: 5 1⁄8 in/130.6 mm
`Weight Range: 110-220 lbs/50-100 kgs
`Tube Clamp Screw Torque: 88 in/lbs (10 Nm)
`Air spring operating psi: 0-20 psi/0-.68 bar
`Material: Aluminum/Stainless Steel
`Harmony-4R150
`Weight: 1.4 lbs/640 grams
`Height: 5.0 in/127 mm
`Weight Range: 220-330 lbs/100-150 kgs
`Receiver Set Screw: 133 in/lbs (15 Nm)
`Adapter 4-Hole pattern: 120 in/lbs (13 Nm)
`Air spring operating pressure: 0-40 psi/0-1.36 bar
`Material: Aluminum/Stainless Steel
`10.00 LIMITED WARRANTY
`Otto Bock HealthCare (Otto Bock) warrants all of its products, to the original purchaser, to be free from defects in
`materials and workmanship. This warranty applies, subject to normal wear and tear, when the products are used as
`intended, without unapproved modifications, following all Otto Bock instructions and requirements; and when they
`are fitted by or under the direct supervision of certified/licensed practitioners who meet all Otto Bock product-
`specific training requirements for a given product.
`
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`GB
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`Harmony • Instructions for Use
`
`The duration of our Limited Warranties varies by product, but all are effective from the date of fitting to a patient.
`The duration of the Limited Warranty for some components may be doubled when incorporated into a finished
`device in which all of the components are manufactured by Otto Bock and installed in conformance with all Otto
`Bock recommendations. Otto Bock’s sole obligation under this Limited Warranty shall be to repair or replace at no
`charge or to refund the cost of the system or component thereof to the original purchaser, at Otto Bock’s sole
`discretion.
`The Limited Warranty for the Harmony P2 is 12 months, and qualifies for extension to 24 months when in finished
`devices utilizing all Otto Bock components.
`THE EXPRESS WARRANTIES SET FORTH HEREINABOVE ARE IN LIEU OF ALL OTHER WARRANTIES
`EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, ANY WARRANTIES OF MERCHANTABILITY OR
`FITNESS FOR A PARTICULAR PURPOSE, AND ALL SUCH OTHER WARRANTIES ARE HEREBY DISCLAIMED
`AND EXCLUDED BY OTTO BOCK.
`IN NO EVENT SHALL OTTO BOCK’S LIABILITY OF ANY KIND INCLUDE ANY SPECIAL, INCIDENTAL OR
`CONSEQUENTIAL DAMAGES, EVEN IF OTTO BOCK SHALL HAVE BEEN ADVISED OF THE POSSIBILITY OF
`SUCH POTENTIAL LOSS OR DAMAGE.
`Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation
`may not apply to you.
`
`Otto Bock HealthCare
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`Harmony HD addendum to the Instructions for Use
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`1.2 Patient Information – Proper maintenance and care requires flushing 1-2 ounces of distilled water
`(about 5-10 pumps) through the Harmony system after contact with salt water or perspiration.
`
`2.0 Components – New components included in the Harmony HD are filtered straight- and 90˚ elbow
`barbed socket connectors, and a vacuum gauge assembly. Please see the testing directions in the
`Instructions for Use manual, page 6.
`
`2.1 Harmony HD Replacement parts
`Additions:
`• 4Y352 Air Spring Pump Kit
`• 4Y351-5 5 pack of replacement rubber air valves
`• 4Y350 90 degree filtered socket connection barb
`Changes:
`• 4Y348 is a Yellow elastomer rod and was article number SL=2300-7027
`Deletions:
`• SL=2300-7012 was an Elastomer cup
`• SL=2300-7023 was a1/4” gray washer
`
`5.1.1 Creating channel in the socket for the Harmony HD – please use 1/4 - 28 tap.
`
`5.5 Adjusting the Harmony HD air shock is not required. The compression of the Harmony HD
`unit is made through the elastomer rod adjustment. Adjusting the Harmony HD’s air spring is only for
`patients who require additional compression resistance during short periods of increased activity
`(possibly basketball, long-distance running, etc). The air spring pump kit article number is 4Y352.
`
`Patented: 5258037, D.429335 (U.S.), 2098945 (Canada), Patents Pending. An ISO 9001/EN 46001 Certified Company
`Harmony® is a registered trademark of Otto Bock HealthCare LP. ©2004 Otto Bock HealthCare LP. • Printed in the USA • 04030405.2 • 3/04
`
`USA 800.328.4058 • Fax 800.962.2549
`Canada 800.665.3327 • Fax 800.463.3659
`www.ottobockus.com • www.ottobock.ca
`usa.customerservice@ottobock.com • info@ottobock.canada.de
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