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3.2 Technical Data

Model 7000P

Specifications

min (imp)

max (imp)

min (si)

max (si)

Packing Length

48 in

122 cm

Length, Traction Frame
to Hip Pivot

48 1/2 in

123 cm

Weight of Device

26 lbs.

12 kg

Thigh Adjustment

12 in.

20 in.

30 cm

51 cm

Calf Adjustment
Short Foot Bar

11 in

20 in

28 cm

51 cm

Long Foot Bar

14 in

23 in

36 cm

58 cm

Leg Length
Short Foot Bar

23 in

40 in

58 cm

102 cm

Long Foot Bar

26 in

43 in

66 cm

109 cm

Range Of Motion (ROM)

0°

110°

Speed

30°/minute

80°/minute

Pause

0 seconds

30 seconds

Timer

0 minutes

24 hours

Mode of Operation

Continuous

Power Supply

Input 100-240 VAC 1.6A 50-60Hz
Output 15 VDC 2.0A
Class II

Electric Shock Classification

Type B

Medical Device Classification

Class 1 (USA)
Class IIa (93/42/EEC)

230604

3.3 Electromagnetic Compliance

Danger!

Equipment not suitable for use in the presence of flammable anesthetic mixture with air or Nitrous Oxide.

Содержание 7000P

Страница 1: ...LiteLift PRO CPM Device Model 7000P Instructions for Use 2008 Otto Bock HealthCare LP Printed in Canada 08011420 1C MML7POM1 Rev B 09 08 ...

Страница 2: ...a qualified individual only Use specified power supply only Type B applied part Alternating Current Direct Current Attention Consult Accompanying Documents Off Power Disconnection from the mains On Power Connection to the mains Protective Earth Ground Dispose of through your Registered Waste Carrier or Take back Facility Indicates CSA certification to North American standards Indicates compliance ...

Страница 3: ...ng LiteLift PRO for adjustments and Patient Use 11 5 0 Patient Alignment and Setup 13 5 1 Aligning the Knee and Hip Axis 13 5 2 Attaching Thigh and Calf Support Bars 14 5 3 Attaching Thigh and Support Sling 15 5 4 Attaching Soft Boot 16 5 5 Attaching Foot Bar and Plate 16 5 6 Changing Orientation of Footplate 17 6 0 Operating the LiteLift PRO 18 6 1 Setting up the LiteLift PRO Controller 18 6 2 Op...

Страница 4: ...ian s prescription 1 3 Clinical Advantages Maintenance of a good range of motion Prevention of intra articular adhesions Prevention of extra articular contractures Reduction of post operative pain following Prevention of negative effects of immobilization 1 4 Indications Immediate post operative management after the following where indicated ACL reconstruction Total Knee Replacement Ligament recon...

Страница 5: ...room Danger Disconnect the electrical supply before servicing or cleaning Failure to do so could result in electrical shock or personal injury Danger Do not use the device power supply or controller if it appears damaged or if there are exposed wires Danger To prevent potential physical injury such as strangulation and choking keep the device away from children or individuals with mental or physic...

Страница 6: ...pliant with the requirements of IEC 60601 1 2 2004 Attention The equipment should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary verify operation in that configuration Attention Portable and mobile RF communications equipment can affect Medical Electrical Equipment Attention Use only manufacturer s supplied replacement components Attention Do not us...

Страница 7: ...scomfort The patient can restart the device in the opposite direction upon pressing the START STOP button a second time 3 0 LiteLift PRO Components and Technical Data 3 1 LiteLift PRO Replacement Parts Ordering Information Description Part No Power Adaptor GlobTek GTM21097 5015 L480SA031 Power Cord North America 14157 5 Power Cord elsewhere please consult Customer Service for the correct Power Cor...

Страница 8: ...hort Foot Bar 23 in 40 in 58 cm 102 cm Long Foot Bar 26 in 43 in 66 cm 109 cm Range Of Motion ROM 0 110 Speed 30 minute 80 minute Pause 0 seconds 30 seconds Timer 0 minutes 24 hours Mode of Operation Continuous Power Supply Input 100 240 VAC 1 6A 50 60Hz Output 15 VDC 2 0A Class II Electric Shock Classification Type B Medical Device Classification Class 1 USA Class IIa 93 42 EEC 230604 3 3 Electro...

Страница 9: ... Support Bar 1 Calf Support Bar 1 Instructions for Use Note Save packaging for storage when the device is not in use Additionally if it is ever necessary to return for service this packaging provides all the protection that is required under warranty BEFORE USE 1 Allow device to reach room temperature for a minimum of one hour prior to use 2 Tighten all knobs and fasteners 3 Before patient use ver...

Страница 10: ...g 2 and the other end to the CPM Device Fig 3 Pos 1 and tighten the lock nut Fig 3 å ç Connecting the Pendant Cable to a CPM device 2 Connect the Power Adaptor connector on the end of the Motion Unit and tighten the plug s lock nut Fig 3 Pos 2 3 Connect the Power cord to the Power Adaptor Plug the other end of the Power cord into a standard grounded wall outlet 8 ...

Страница 11: ...s to hospital beds with a standard bed mount and comes with a self storing Wrap Spring Clutch which makes it easier for hospital staff to apply and store the LiteLift PRO while avoiding contamination The Wrap Spring Clutch conveniently locks at any angle and reduces the functional lifting weight of the CPM by almost half It also stores the CPM out of the way when not in use Fig 4 9 ...

Страница 12: ...ht above the mattress it may be necessary to add optional extensions to the Post Tube to obtain enough height To add an extension unscrew the Post Cap and replace it with a Post Tube Extension Screw the Post Tube Extension onto the Joint and screw the Post Cap into the top of the Post Tube Extension 4 3 2 Raising and Storing LiteLift PRO while attached to bed Danger Failure to observe the followin...

Страница 13: ...the CPM Device Wrap Spring Clutch Assembly away from the patient The Wrap Spring Clutch will automatically lock in place at any angle unless the Clutch Release is pressed Fig 10 Fig 10 1 Clutch release lock 2 Clutch release å ç Fig 11 Make sure the CPM is in a fully upright Fig 4 page 9 position and that the Clutch Release Lock is in the locked position If the Clutch Release Lock does not fully en...

Страница 14: ...ace if the Clutch Release is released Once the CPM Device is lowered to the bed Fig 14 make sure the Clutch Release Lock is correctly engaged Fig 15 Fig 14 Fig 15 Finally adjust the Double Clamp so that the CPM device rests flat on the mattress Attention The Wrap Spring Clutch is designed to only support the CPM device It is NOT designed to support both the CPM and the user s leg 12 ...

Страница 15: ...ce to bed With the patient in the supine position release the safety strap if attached and gently lower the LiteLift PRO over the patient s limb according to directions in section 4 3 3 Make sure that the LiftLift is completely supported by the bed you may have to adjust the double clamp to do so Also make sure that the Clutch Release Lock is correctly engaged 5 1 Aligning the Knee and Hip Axes Fi...

Страница 16: ...s not tightened securing alignment An error code will occur requiring you to turn the device off and on again to re set 5 2 Attaching the Thigh and Calf Support Bars Fig 18 1 Sling 2 Pad 3 Paddle 4 Sling Clip 5 Support Bar å ç é ê è The Thigh and Calf Support Bars and Paddles in conjunction with pads and slings support the patient s leg during CPM use and can be used on both left and right legs Fi...

Страница 17: ...thigh and calf Fig 20 Fig 21 5 3 Attaching Thigh and Support Slings First position the Thigh Sling beneath the patient s leg then slide Sling through the Thigh Paddle Clips Velcro side down Fig 22 making sure that the split side of the Sling is on the same side as the Paddle Arm Next snap the clips into place on the Clip Posts Fig 23 and adjust Sling to patient s thigh Fig 22 Fig 23 Equally adjust...

Страница 18: ...Boot already attached to Foot Plate attach Foot Plate to Foot Plate Support Bar Fig 25 Pos 4 Fig 26 making sure that the lateral wings of the bar fit correctly into Fitting the bar should not be able to rotate Next slide the Calf Length Adjustment Bar proximally until the patient s foot rests comfortably against plate Tighten knob and secure boot around patient s foot with Velcro tabs Fig 25 1 Foo...

Страница 19: ...e recommend that patients using the LiteLift PRO are checked at least once every shift or anytime the patient removes and reapplies device to ensure that they are properly aligned and secured 5 6 Changing Orientation of Foot Plate The Foot Plate is designed to work on both left and right sides with the Support Bar lateral to the patient s leg when in use To switch sides first loosen Foot Plate Kno...

Страница 20: ...ig 32 SD Memory Card being inserted into Pro Controller Each PRO Series CPM Base Unit controls one or more motors and ancillary equipment according to commands received from the PRO Controller pendant The firmware in the PRO Controller and base unit can be upgraded Fig 32 The SD Memory Card can also store and download patient therapy profiles and doctor s prescriptions PRO Controller Overview Mode...

Страница 21: ...s and can be obtained from your account representative NOTE To protect the patient settings may be locked to allow only medical clinical professionals to make changes to the CPM device settings Locking the settings will require a Special Key Sequence Please contact your Authorized Service Representative Dealer or Distributor for this or answers to any other questions you may have Setting Mode Info...

Страница 22: ...Fig 34 Pos B C D E F L contains relevant CPM Device and setting information The bottom of each screen Fig 34 Pos H Q P O contains a row of icons that are representative of the various screens Icons are selected with the Soft Keys and are highlighted when selected The Joint Set up Screen Fig 34 allows for the setting of Force Speed Pause Time and Range of Motion of all involved CPM Device joints Fi...

Страница 23: ...rast Volume setting E Total system hours System Settings Screen The System Settings Screen Fig 36 allows Time Date Operating Language Warm Up Mode and Contrast Volume to be changed Fig 37 System Settings Firmware Version System Hours Set Date Time Select Language Warm Up Mode Contrast Volume Patient Mode English Ask to Run B Soft Keys A Screen Commands C Direction Keys D Select Key E Start Stop Bu...

Страница 24: ...ed Extension Flexion Force Pause Speed The Cursor selects a functional setting Fig 39 Knee Joint Setup Force Pause Speed Extension Flexion Force Pause Speed By selecting a functional setting highlighted by the cursor the slider bar will appear ...

Страница 25: ...in Setting or Operating Mode Fig 37 Pos E page 21 Fig 40 Connecting the Pendant Cable to the pendant 6 2 2 Connecting the PRO Controller to the CPM Device Note Make sure the CPM system is unplugged and turned off when connecting the Pendant Cable If it is not already connected plug the small connector side of the Cable into the bottom of the ProController To disconnect the Pendant cable from the P...

Страница 26: ...exion setting window F Patient extension setting window G Extension setting limit window H Icons for joint set up screens E ROM setting column M Angle display O Soft key Q Icon for patient profile screen P Icon for system settings screen R Patient lock out setting The PRO Controller has several screens available in the Setting Mode including the Joint Set up Screens one or more depending on the CP...

Страница 27: ...4 and press the Select Key to select that parameter A Setting Slider Bar will appear Fig 45 that will allow you to change the setting with the left and right Direction Keys Once you have chosen your setting press the Select Key to set and scroll to the next parameter setting Range of Motion ROM parameters Use the left and right Direction Keys to navigate to the ROM Setting Column Fig 43 Pos E page...

Страница 28: ...that parameter 6 2 5 Patient Profile Screen Settings and Patient Profiles Fig 47 Patient Profile Hours Load Save to Memory Card Current Usage Treatment Memory Card Cycles Reset Usage Days Used Days Since Reset Session Duration Sessions Day PROFILE1 B Treatment session setting C Load profile setting A Patient profile icon Patient Profile Screen The Clinical Professional can set other parameters and...

Страница 29: ... Cycles Reset Usage Save Cancel Days Used Days Since Reset Session Duration Sessions Day Naming a patient profile To create a new Patient Profile which will be stored on the unit s removable SD Memory Card it is important that you first make all desired settings in the Setting Screens Once you have created your settings select Save to Memory Card in the Patient Profile Screen Fig 47 Pos C page 26 ...

Страница 30: ...u want to run Warm up Extension Flexion Speed Warm up Mode Pop up Window The Warm Up Mode has several settings which are set by the Clinical Professional Ask to run Always run and Never Run If the Clinical Professional has selected Ask to run a pop up window will appear whenever the device is run for the first time after being powered on Fig 50 The patient can select yes or no using the PRO Contro...

Страница 31: ...he device to water including ice bags Do not expose to extreme temperatures Attention Turn the power off before unplugging Attention Do not use the device power supply or controller if it appears damaged or if there are exposed wires Attention Do not pour cleaning solution directly onto the device This may allow fluids to damage the device Note When the device is not in use turn it off and unplug ...

Страница 32: ...with the Operating Screen Fig 52 Operating Screen with functional elements called out use to tab left or right through screens or directly access flexion and extension settings E Soft Keys F Direction Keys G Select Key A Screen Title H Start Stop Button I Session Number J Time Knee Joint Setup Force Pause Speed Extension Flexion Force Pause Speed B Flexion ROM Setting Box C Display Screen D Extens...

Страница 33: ...o Pause Do you want to run Warm up Extension Flexion Speed Warm up Mode Pop up Window If the automatic Warm up feature is enabled it with automatically begin with the warm up It may also provide a pop up window Fig 53 to ask if you d like to do the warm up or not To select yes or no simply use the Direction Keys Fig 52 page 30 to move the Cursor Box over the desired selection then press the Select...

Страница 34: ...ning your leg will experience while on the LiteLift Pro Your doctor may set up the LiteLift PRO so that you can adjust these angle settings You ll know you can make such changes if you see a box on the left side column that has numbers in it Fig 55 To make changes simply use the Direction Keys Fig 52 Page 30 to navigate to the desired Flexion or Extension box in the left hand column Press the Sele...

Страница 35: ...th the Direction and Select Keys Fig 57 Force is set on a scale from 1 to 5 Pause time can be set from 0 to 30 seconds Speed can be set on a scale from 1 to 10 To make a change simply use the Direction Keys to navigate the Cursor Box over the desired function Fig 57 then press the Select Key A Slider Bar will appear Fig 58 which can be adjusted with the Left and Right Direction Keys Adjusting the ...

Страница 36: ...evice operates to its set limits over several complete cycles For Range of Motion ROM settings verify device calibration by observing the ROM of the device while taking a visual reading using a goniometer at the device s anatomic pivot points Compare the ROM settings of the device with the goniometer readings ROM readings should be within 5 of the set parameters If the readings do not fall within ...

Страница 37: ...sition No connection to PRO Controller Check Pendant Cable connections at both ends ensure the lock nut is tight Internal electrical malfunction Return for service Insufficient lifting power Force setting too low Increase force setting Internal malfunction Return for service Mechanical binding or jerking motion Internal mechanical malfunction Return for service Obstruction Remove obstruction PRO C...

Страница 38: ...V contact 8 kV air with documented necessary Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines Mains power quality should be that of a typical commercial o...

Страница 39: ... should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of known RF transmitting devices and equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects a...

Страница 40: ... will perform under warranty If the product is received incomplete missing parts will automatically be replaced at the buyer s expense The Manufacturer also reserves the right at its own cost to upgrade or replace parts or sub assemblies to the latest production standards The Manufacturer will normally perform the repair and return the product or provide a replacement within 30 days from the day o...

Страница 41: ...39 ...

Страница 42: ... in Canada by Fabriqué au Canada par Fabricado en Canadá por Otto Bock HealthCare Canada Ltd 901 Dillingham Rd Pickering ON Canada L1W 2Y5 Tel 905 420 3303 Fax 905 420 3970 Registered to ISO 13485 Quality Assurance ...

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