Related Manuals for Otto Bock 7000P
Summary of Contents for Otto Bock 7000P
- Page 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...
- Page 2 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. Alternating Current Protective Earth (Ground) Direct Current...
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Page 3: Table Of Contents
Table of Contents 1.0 Intended Use ........................... 2 1 .1 Introduction ..............................2 1 .2 Application ..............................2 1 .3 Clinical Advantages ............................2 1 .4 Indications ..............................2 1 .5 Contraindications ............................2 1 .6 Declaration of Conformity ..........................2 2.0 Safety Considerations ...................... -
Page 4: Intended Use
Do not proceed with treatment until the physician has approved continued use of the device. 1.6 Declaration of Conformity Otto Bock as manufacturer with sole responsibility declares that LiteLift® PRO Knee CPM Device conforms to the requirements of European Directive for medical products 93/42/EEC. -
Page 5: Safety Considerations
2.0 Safety Considerations 2.1 Symbol Legend Danger! Warning messages regarding possible risks of accident or injury. Attention! Warning messages regarding possible technical damages. Note! Information regarding operation of the device. Note! Information for service staff. Attention! Please read the Instructions for Use first. 2.2 General Safety Considerations Attention! Read manual before operating the device. -
Page 6: Safety Features
Danger! Before raising the CPM upright for storage, place the CPM into full flexion to avoid foot plate interference with mounting bar or bed frame. Danger! When applying the CPM to patient, make sure that the CPM is fully supported on the bed: the CPM should NOT be supported by lift mechanism while applied to patient. -
Page 7: Litelift Pro Components And Technical Data
Reverse-On-Load The device is designed to automatically reverse direction in the event that an obstruction occurs. Restricted Patient Access The LiteLift PRO provides immediate patient access to all operating controls via the PRO Controller pendant. Restricted access is also possible by means of the controller settings. Start/Stop Button The START/STOP button on the controller gives the patient the ability to stop or interrupt the action of the device should he/she experience discomfort. -
Page 8: Technical Data
3.2 Technical Data Model 7000P Specifications min (imp) max (imp) min (si) max (si) Packing Length 48 in 122 cm Length, Traction Frame 48 1/2 in 123 cm to Hip Pivot Weight of Device 26 lbs. 12 kg Thigh Adjustment 12 in. -
Page 9: Setting Up The Litelift Pro
4.0 Setting Up the LiteLift® PRO 4.1 Unpacking the LiteLift® PRO Remove all the LiteLift® PRO CPM system components from the carton. During unpacking, make sure that all components are present and that there is no external damage. Report any substantial damage. Fig. -
Page 10: Connecting Your Components
4.2 Connecting your Components Fig. 2 Connecting the Pendant Cable to the pendant. 1. Connect the appropriate end of the PRO Controller cable to the PRO Controller (Fig. 2), and the other end to the CPM Device (Fig. 3, Pos. 1), and tighten the lock nut. Fig. -
Page 11: Bed Setup
4.3 Bed Setup Danger! LiteLift PRO must be securely fastened to the hospital bed. Danger! Never release the mounting knob while there is a patient in the bed. Fig. 4 The LiteLIft® PRO mounts 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. -
Page 12: Attaching Litelift® Pro To Bed
4.3.1 Attaching LiteLift® PRO to bed Fig. 5 To attach the LiteLift® PRO to bed, first attach the smooth, round side of the Double Clamp to the Post Tube (Fig. 5). Then attach the octagonal side of Double Clamp to bed's horizontal Traction Bar. The Traction Bar must have a flat surface facing up. -
Page 13: Lowering Litelift Pro For Adjustments And Patient Use
Danger! The Clutch Release Lock must be engaged in the locked position when the CPM Device is stored and when it is in position for patient use. Attention! Before raising the CPM Device upright for storage, place it into full flexion to avoid foot plate interference with mounting bar or bed frame. - Page 14 Fig. 12 Fig. 13 Next, still supporting the CPM Device with one hand, press the Clutch Release (Fig. 12) and lower device to the bed. (Fig. 13) The Wrap Spring Clutch will automatically lock in place if the Clutch Release is released. Once the CPM Device is lowered to the bed (Fig.
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Page 15: Patient Alignment And Setup
5.0 Patient Alignment and Set Up Fig. 16 CALF SUPPORT BAR FOOT PLATE THIGH SUPPORT BAR KNEE AxIS ADJUSTMENT KNOB ADJUSTMENT KNOB (HIDDEN) FOOT PLATE (HIDDEN) THIGH SUPPORT BAR CALF SUPPORT POST TUBE CONNECTION THIGH LENGTH DOUBLE CLAMP ADJUSTMENT KNOB THIGH BAR TRACTION BAR PRO CONTROLLER... -
Page 16: Attaching Thigh And Calf Support Bars
Step 3: Loosen and push down on the Thigh Length Adjustment Knob (Fig. 17, Pos. 5) while pulling up on the Thigh Bar (Fig. 17, Pos. 4) to set the distance between the device knee axis and the device hip axis EQUAL to the distance measured between the patient’s greater trochanter and knee center in Step 1. -
Page 17: Attaching Thigh And Support Sling
There are two sizes of White Foam Spacer Pads, a larger one for the Thigh Paddle, and a smaller one for the Calf Paddle. Apply these first (Fig. 20) and then apply the appropriate Patient Kit Soft Squares (Fig. 21). Next, loosen Thigh and Calf Support Bar Adjustment Knobs (Fig. -
Page 18: Attaching Soft Boot
5.4 Attaching Soft Boot Attach Soft Boot to Foot Plate by sliding over top of Plate (Fig. 24). Secure bottom with Velcro® tab. Fig. 24 5.5 Attaching the Foot Bar and Plate To adjust Foot Plate to patient, first loosen the Calf Length Adjustment Knob (Fig. 25, Pos. 3) and slide distally. With the Soft Boot already attached to Foot Plate, attach Foot Plate to Foot Plate Support Bar (Fig. -
Page 19: Changing Orientation Of Footplate
Fig. 27 Adjust Foot Plate position by pulling on Foot Plate Adjustment Knob (Fig. 25, Pos. 1, page 16; Fig. 27) so that the ankle is flexed appropriately and the toes are pointing at the ceiling. Tighten all knobs and then run the LiteLift PRO through several cycles to ensure proper alignment and patient comfort. Finally, make sure the PRO Controller is in Patient Mode and show patient how to operate LiteLift PRO with the PRO Controller (see section 7.0). -
Page 20: Operating The Litelift Pro
6.0 Operating the LITELIFT® PRO-for Medical Personnel Attention! The controller must be positioned so that patients and medical personnel can reach the START/STOP button during use. 6.1 Setting up the LiteLift PRO Controller Fig. 31 SD Memory Card being inserted into Pro Controller. - Page 21 Fig. 33 Knee Joint Setup Operating Mode Screen Flexion with all settings made available to patient. Force Pause Speed Force Pause Speed Extension The Operating Mode Screen (Fig. 33) is normally the first screen displayed. The Operating Mode Screen displays current settings and also allows limited access to patient operational controls, including Force, Pause Time, Speed, and Range of Motion settings.
- Page 22 Fig. 34 I. Session number Joint Set-up Screen with functional J. Time A. Screen name elements called out. Knee Joint Setup B. Patient ROM lock out settings Flexion K. Force, pause time Force C. Flexion setting limit window and speed setting Pause Speed D.
- Page 23 Fig. 36 System Settings System Settings Set Date/Time A. Time/Date setting Screen Select Language B. Operating Language setting English Warm-Up Mode C. Warm-Up Mode setting Ask to Run Contrast/Volume D. Contrast/Volume setting Firmware Version System Hours E. Total system hours Patient Mode The System Settings Screen (Fig.
- Page 24 Fig. 38 Knee Joint Setup The Cursor selects a functional setting. Flexion Force Pause Speed Force Pause Speed Extension Fig. 39 Knee Joint Setup By selecting a functional setting Flexion highlighted by the cursor, the slider Force bar will appear. Pause Speed Force...
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Page 25: Connecting The Pro Controller To The Cpm Device
PRO Controller Keypad Soft Keys are used to navigate between the PRO Controller Setting and Operating Screens. Pressing the leftmost and rightmost keys (Fig. 37, Pos. B, page 21) moves between the various Setting Screens. Pressing the central two keys moves to the Operating Screen. -
Page 26: Cpm Device Parameters: Overview
A. Start up Screen Fig. 42 Start-up Screen B. Pro Controller The PRO Controller will automatically recognize which PRO Series CPM Device it is connected to, and will flash a Start up Screen (Fig. 42). for about 10 seconds to indicate that it has been properly connected. It will then progress to standby C. -
Page 27: Cpm Device Parameters: Overview
6.2.4 Joint Set-up Screen: Setting CPM Device Parameters Force, Pause, Pause Time and Speed Parameters for the specific joints in a CPM device are set in the Joint Set-up Screen (Fig. 44). To set these parameters, use the Soft Keys to navigate to the desired Joint Set-up Screen if there is more than one joint involved. -
Page 28: Patient Profile Screen: Settings And Patient Profiles
A Status Window in the center (Fig. 43, Pos. M, page 24) will show the CPM device’s current angle or a countdown timer when it is in the Pause portion (Fig. 16) of its cycle. Fig. 46 Knee Joint Setup Countdown Timer displayed Flexion... -
Page 29: System Settings Screen
A Patient Profile stores therapy settings for Force, Time, Speed, Pause, and ROM goals. It also includes lock-out and treatment session information. These profiles make it easy to apply therapy settings to the patient at a later time, or to another patient with similar therapy needs. -
Page 30: Warm-Up Mode
Time, Date, Operating Language, Screen Brightness, Volume and Warm-up Mode can be changed within the System Settings Screen (Fig. 49, page 27). To make changes, scroll to the desired setting and select. Scroll within the selection boxes to select the desired settings. The Warm-Up Mode (Fig 49, Pos. -
Page 31: Patient Operation Of The Litelift Pro
7.0 Patient Operation of the LiteLift Pro Note: Please make sure that the patient is educated concerning the operation of the PRO Controller and CPM device. SAFETY CONSIDERATIONS Attention! Keep hair, loose clothing, fingers, etc., away from moving components of the device. Attention! Do not expose the device to water, including ice bags. - Page 32 Danger! Patients are responsible for using the device according to these Instructions for Use. Patient Instructions The LiteLift PRO Knee CPM Device is designed to offer continuous passive motion for your knee after surgery. The LiteLift PRO is operated via a Pendant controller, which allows you to start, pause and stop the activity of the device. The Pendant also allows you to make changes to certain functional settings, depending on your Physician’s prescription.
- Page 33 How to Start and Stop the CPM Device Simply press the Start/Stop Button once to begin your session (Fig. 52, page 30). To stop the device at any time, press the Start/Stop Button again. When restarted the device will begin by moving in the opposite direction. Warm-up Feature The LiteLift PRO has a Warm-up feature which moves slowly through your flexion and extension range.
- Page 34 Changing Functional Parameters Depending on your Physician’s prescription, you may be able to make changes to flexion and extension Ranges of Motion, to the Force, to the amount of time the device Pauses between flexion and extension, and to the Speed at which the device operates.
- Page 35 Force, Pause and Speed Settings Fig. 57 Knee Joint Setup Selection Cursor selected Flexion Force Pause Speed Force Pause Speed Extension Fig. 58 Knee Joint Setup Slider Bar selected Flexion Force Pause Speed Force Pause Speed Extension Force, Pause and Speed Settings can also be changed with the Direction and Select Keys. (Fig. 57) •...
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Page 36: Maintenance-For Medical Personnel
• Perform a complete recalibration and subsequent check of electronic and mechanical safety systems including Reverse-On-Load function and Range of Motion controls. • Complete a final check of the device in accordance with Otto Bock Final Inspection criteria. (These are available through your Sales representative, Otto Bock Customer Service, or your local distributor.) Sterilization •... -
Page 37: Troubleshooting Guide
9.0 Troubleshooting Guide PROBLEM POSSIBLE CAUSE Check Power Cord and Power Supply connections and ensure lock nut is tight (the No power to base unit Power Supply’s green light glows when it is connected to the mains AC power), ensure Device will not power up Power Switch is in the On position No connection to PRO... -
Page 38: Appendix For Electromagnetic Compliance
10.0 Appendix for Electromagnetic Compliance IEC 60601-1-2:2004 Table 201 Requirements The equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the equipment should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –... - Page 39 IEC 60601-1-2:2004 Table 204 Requirements: The equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the equipment should assure that it is used in such an environment. IEC 60601 test Compliance Immunity test Electromagnetic environment –...
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Page 40: Limited Warranty
11.0 Limited Warranty New Product Limited Warranty The Manufacturer warrants the product to be free from defects in material and workmanship for a period of (2) two years for all major components (motor, power transmission parts and circuit boards) and for a period of 90 days for all housing parts, knobs, hardware and sub-assemblies (excluding disposables). - Page 42 Manufactured 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...