Otto Bock 7000P User manual

LiteLift PRO CPM Device
Model 7000P
Instructions for Use
©2008 Otto Bock HealthCare LP • Printed in Canada • 08011420.1C MML7POM1 Rev. B 09/08

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.
Danger Electric Shock:
Service by 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 to safety and
quality standards throughout all
member states in the EC
Danger Explosive Risk: If used with
flammable anaesthetic
This Way Up
Fragile
Keep Dry
230604

1
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............................................................................................................. 3
2.1 Symbol Legend .............................................................................................................................................. 3
2.2 General Safety Considerations....................................................................................................................... 3
2.3 Safety Features.............................................................................................................................................. 4
3.0 LiteLift PRO Components and Technical Data ....................................................................... 5
3.1 LiteLift® PRO Replacement Parts Ordering Information................................................................................. 5
3.2 Technical Data ............................................................................................................................................... 6
3.3 Electromagnetic Compliance.......................................................................................................................... 6
4.0 Setting up the LiteLift PRO ..................................................................................................... 7
4.1 Unpacking the LiteLift® PRO ......................................................................................................................... 7
4.1.1 Included your Kit ................................................................................................................................... 7
4.2 Connecting your Components ........................................................................................................................ 8
4.3 Bed Setup...................................................................................................................................................... 9
4.3.1 Attaching LiteLift® PRO to bed ........................................................................................................... 10
4.3.2 Raising and Storing LiteLift® PRO while attached to bed.................................................................... 10
4.3.3 Lowering 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 Operating the LiteLift PRO........................................................................................................................... 18
6.2.1 PRO Controller Overview................................................................................................................... 18
6.2.2 Connecting the PRO Controller to the CPM Device............................................................................ 23
6.2.3 CPM Device Parameters: Overview.................................................................................................... 24
6.2.4 CPM Device Parameters: Overview.................................................................................................... 25
6.2.5 Patient Profile Screen: Settings and Patient Profiles ........................................................................... 26
6.2.6 System Settings Screen...................................................................................................................... 27
6.2.7 Warm-Up Mode .................................................................................................................................. 28
7.0 Patient Operation of the LiteLift PRO .................................................................................. 29
8.0 Maintenance – for Medical Personnel .................................................................................. 34
9.0 Troubleshooting Guide.......................................................................................................... 35
10.0 Appendix for Electromagnetic Compliance ......................................................................... 36
11.0 Limited Warranty ................................................................................................................... 38

1.0 Intended Use
1.1 Introduction
The LiteLift® PRO Continuous Passive Motion (CPM) system is designed for the rehabilitation of the lower limbs following
knee or hip surgery, and is designed primarily for use in the hospital environment and works only with the PRO Series
Pendant Controller.
The LiteLift® PRO has a lifting mechanism which allows it to be attached directly to a standard hospital bed frame.
It conveniently stores out of the way when not in use. A clutch mechanism locks at any angle and also reduces the
functional lifting weight of the LiteLift® PRO by almost half.
The patient’s leg is suspended from the device rather than being supported by it.
The foot, calf and thigh supports along with the patient kit attachments are all independently adjustable to ensure that the
LiteLift® PRO can be anatomically aligned for a wider range of patient sizes.
1.2 Application
Continuous Passive Motion (CPM) is best applied immediately post-operative and continued, uninterrupted, for up to six
weeks as per physician’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 reconstruction
• Manipulation under anesthesia
• Meniscal repair
• Stabilized intra- or extra-articular fractures of the femur and tibia
1.5 Contraindications
Do not use the device if any of the following are present:
• Untreated or uncontrolled infection
• Unstable fractures
• Hemorrhage
Danger!
Upon using the device, if signs of infection such as hyperthermia, fever, redness, irritation, warmth, swelling,
bleeding, and/or increased persistent pain are present, discontinue operation of the device and contact the
patient’s physician.
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.
2

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 rst.
2.2 General Safety Considerations
Attention!
Read manual before operating the device. Clinicians and others responsible for the operation of this device
should become thoroughly familiar with its capabilities and proper operation procedures prior to actual
patient use.
Danger!
Do not use in a volatile atmosphere. Equipment not suitable for use in the presence of ammable anaesthetic
mixture with air or Nitrous Oxide.
Danger!
Do not use CPM device in operating rooms. This CPM device is only to be used outside the operating 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 physical conditions that preclude the safe use of the device.
Danger!
Unplug the power supply by grasping the plug, not the cord.
Danger!
Unless using the device, turn the device off and unplug from the power supply.
Danger!
Do not pour cleaning solution directly onto the device. This may allow uids to enter the device and cause
electrical problems, or wash lubricants away from running components, reducing the life span of the device.
Danger!
Position the device in a comfortable and secure position. Ensure that the device is stable through its full range
of motion.
Danger!
Keep hair, loose clothing, ngers, etc., away from moving components of the device.
3

Danger!
Before raising the CPM upright for storage, place the CPM into full exion 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.
Danger!
The controller must be positioned so that patients and medical personnel can reach the START/STOP button
during use.
Attention!
Use the device only in accordance with the Physician prescription and these Instructions for Use. Failure to do
so may result in damage to the device and/or personal injury.
NOTE: Patient Kits are for single patient use only.
Attention!
The use of accessories and cables other than those specied, with the exception of accessories and cables
qualied and sold by the manufacturer of the equipment, may result in increased emissions or decreased
immunity of the equipment and may cause the system to be non-compliant 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 conguration.
Attention!
Portable and mobile RF communications equipment can affect Medical Electrical Equipment.
Attention!
Use only manufacturer’s supplied replacement components.
Attention!
Do not use the device if there are mental or physical conditions that preclude patient compliance.
Attention!
Do not expose the device to water or extreme temperatures.
Attention!
Do not use the device near exposed ames, while smoking or near excessive heat.
Turn the power off before unplugging.
Attention!
Select a location for the device and device components (controller, straps, cables and power supply, if
applicable), to prevent a tripping hazard during use.
Attention!
Device must be stored in a location that has a least 19 inches of clearance at all times.
2.3 Safety Features
Low Voltage
The power supply delivers less than 20 volts DC to the device. The LiteLift PRO will tolerate electrical supply variations
which may be found in the home or hospital environments.
4

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. 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 Cord for your region
Pro Pendent Cable .......................................NG-103
Pro Controller Pendant ....................................NG-104
Long Footbar ......................................... 221476 -1
Short Footbar .........................................221476-2
White Foam Pads ........................................221970
Patient Kit ...............................................7100
Customized Double Clamp ...................................13504
Post Tube Extension ...................................... DL009
Post Tube Extension Joint (required with Post Tube Extension) .........D L 011
5

3.2 Technical Data
Model 7000P
Specications 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 Classication
Type B
Medical Device Classication
Class 1 (USA)
Class IIa (93/42/EEC)
230604
3.3 Electromagnetic Compliance
Danger!
Equipment not suitable for use in the presence of ammable anesthetic mixture with air or Nitrous Oxide.
6

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. 1
LiteLift®
PRO Device
with all
components
4.1.1 Included in your Kit
1 Motion unit
1 Power Adaptor
1 Power cord
1 PRO Pendant Controller
1 Pendant Cable
1 Long Footbar
2 White Foam Pads
1 Patient Kit
1 Foot Plate
1 Thigh 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, verify the Range Of Motion (ROM) settings by operating the CPM through one full cycle.
4. Ensure that both Power Cord and PRO Controller Cable are uncoiled from the device.
Attention!
Service should be performed only by qualied technicians. Training is available through the manufacturer.
7

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. 3 åç
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

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. 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

4.3.1 Attaching LiteLift® PRO to bed
Fig. 5
To attach the LiteLift® PRO to bed, rst 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 at
surface facing up. Securely tighten both sides of the clamp.
Fig. 6
The post tubes should be long enough to allow the unit to rest above the mattress a minimum of 8˝ (20cm) (Fig. 6).
Because the Traction Bars on different hospital beds are not all the same height 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 following safety instructions can lead to injury of patient or hospital staff.
Danger!
DO NOT engage the Clutch Release if the CPM Device is not fully supported.
Danger!
Hospital staff must support the CPM Device with at least one hand when lowering the device to the bed.
Danger!
Always store the CPM Device in a vertical position.
10

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 exion to avoid foot plate interference with
mounting bar or bed frame.
Attention!
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.
Fig. 7
Fig. 8 Fig. 9
To raise the CPM Device from the bed between treatments, make sure Clutch Release Lock is correctly engaged
(Figs. 7, 8, 9), and simply lift 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
åç
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 engage it may be necessary to push/pull the Clutch Release slightly.
Attach safety strap.
4.3.3 Lowering LiteLift PRO for adjustments and Patient Use
Danger!
Always fully support CPM and Wrap Spring Clutch when lowering device to bed.
Danger!
Always reengage Clutch Release Lock after lowering device to bed.
Fully support the CPM Device with at least one hand (Fig. 11) before disengaging the Clutch Release Lock. (Fig. 10,
Pos. 2)
11

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. 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 at 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

5.0 Patient Alignment and Set Up
Fig. 16
THIGH LENGTH
ADJUSTMENT KNOB
THIGH BAR
PRO CONTROLLER
PENDANT
THIGH SUPPORT BAR
HIP AXIS OR
HIP JOINT
CALF SUPPORT
BAR
KNEE AXISTHIGH SUPPORT BAR
ADJUSTMENT KNOB
(HIDDEN)
CALF SUPPORT BAR
ADJUSTMENT KNOB
(HIDDEN)
CALF LENGTH
ADJUSTMENT KNOB
(HIDDEN)
FOOT PLATE
CONNECTION
FOOT PLATE
SUPPORT BAR
ACTUATOR ASSEMBLY
FOOT PLATE
ADJUSTMENT KNOB
PRO CONTROLLER
CORD CONNECTOR
DOUBLE CLAMP
TRACTION BAR
CLUTCH ASSEMBLY
POST TUBE
POWER SWITCH
POWER SUPPLY
CONNECTOR
FOOT PLATE
Danger!
Always fully support CPM when lowering device to bed.
Danger!
Always reengage Clutch Release Lock after lowering device 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
Fig. 17
1. Calf Support Bar
Adjustment Knob
2. Knee Axis
3. Thigh Support Bar
Adjustment Knob
4. Thigh Bar
5. Thigh Length
Adjustment Knob
6. Hip Axis
å ç é ê ëè
Step 1: Measure the distance between the patient’s greater trochanter to knee center.
Step 2: With the patient supine (lying down) and the LiteLift PRO lateral to the involved leg, align the patient’s greater
trochanter to the + symbol of the LiteLift PRO’s hip axis (Fig. 17, Pos. 6).
13

14
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.
Step 4: Re-tighten the Thigh Length Adjustment Knob.
IMPORTANT NOTE: The device will not operate if the Thigh Length Adjustment Knob is 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 êè
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 (Fig. 18).
Fig. 19
1. Loosen Knob
2. Retract Knob
3. Apply or
Remove Paddle
å
ç
é
Attach Paddles to the Thigh and Calf Support Bars by loosening and pulling ridged knob on Support Bar (Fig. 19).
Retighten once Support Bar is positioned properly.

15
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 rst (Fig. 20) and then apply the appropriate Patient Kit Soft Squares (Fig. 21). Next, loosen Thigh
and Calf Support Bar Adjustment Knobs (Fig. 17, Pos. 1, 3, page 13) and position Paddles where appropriate (generally
centered on the 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 both sides of the Thigh Sling until there is a nger’s width distance between the patient’s leg and the
paddle. Repeat this procedure with the Calf Sling.

16
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, rst 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. 25, Pos. 4; Fig. 26), making
sure that the lateral wings of the bar t 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. Foot Plate
Adjustment
Knob
2. Soft Boot
3. Calf
Length
Adjustment
Knob
4. Foot Plate
å ç é è
Fig. 26

17
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 exed 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).
Note!
We 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, rst loosen Foot Plate Knob and remove Plate (Fig. 28). Next, loosen Support Bar Connection
Knob (Fig. 29) just enough to slide Support Bar out. Flip Bar over, making sure to correctly engage lateral wings within
Support Bar Connection (Fig. 30). Finally, reattach Foot Plate.
Fig. 28
Fig. 29 Fig. 30

18
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.
6.2 Operating the LiteLift PRO
6.1 PRO Controller Overview
The PRO Controller is connected to the LiteLift PRO CPM Device via a pendant cable, which plugs into the bottom of the
CPM Base Unit (Fig. 31).
Fig. 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 rmware in the PRO Controller and base unit can be upgraded (Fig. 32). The SD
Memory Card can also store and download patient therapy proles and doctor’s prescriptions.
PRO Controller Overview Modes and Screens
The PRO Controller has two main modes: Operating Mode, with 1 or more Joint Operator screens available, and Settings
Mode, which contains multiple settings screens. All screens are controlled with the buttons and keys located on the lower
half of the PRO Controller pendant.