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64-0001 Rev. D
INTEGRITY SPINAL CARE SYSTEM
ISCS
Operator’s Manual
64-0001 Rev. D
Operator’s Manual Integrity Spinal Care System
Integrity Life Sciences, LLC
2189 West Bush Blvd ♦ Tampa, Florida 33612 USA
64-0001 Rev. D
Table of Contents
C H A P T E R 1
Introduction
Introduction 1
C H A P T E R 2
Safety Information
Intended Use 2
Patient Qualifications 2
Contraindications 3
Relative Contraindications 3
C H A P T E R 3
Principles of Operation
Principles of Operation 4
Symbol Definitions 6
Explanation of Diagnostic Monitor 8
Accessories 8
C H A P T E R 4
Getting Familiar with Your Medical Device
Getting Familiar 9
Operator Hand Control Unit 10
Split Table Design 10
Adjustable Lordotic Support 10
Upper Body Support System 11
Patient Safety Switch 11
Foot Platform and Scale 11
Selector Panel 12
Integrity Spinal Care
Decompression Unit 12
Touch Screen Computer 13
Patient Info LEDs 14
System Controls 14
Diagnostics Panel 15
Patient Grab Handles 15
Headpiece 15
Foam Head Supports 15
Knee Support/ Head Pillow 15
Harnesses 16
C H A P T E R 5
Using the Integrity Spinal Care Decompression System
Initialize the Integrity Spinal
Care System 17
Before Patient Mounts 17
Harness the Patient 18
Mount Patient on Foot Platform 18
Enter New Patient Information 18
Naming Patients 18
New Patients 19
Selecting Existing Patients 20
Load Patient on Bed 20
Attach Decompression Unit Belt 21
Attach Upper Harness 21
Before Mounting the Patient for
a Cervical Treatment 21
Foam Head Support Selection and
Placement onto Headpiece 22
Positioning of Patient prior to
Cervical Treatment 22
Connecting the Headpiece 23
Fine Tuning 23
Start Patient Treatment 23
Using the DVD Patient Viewing
System 24
DVD Remote Control 25
Treatment Session Complete 26
Backing Up Database 27
Restoring a Database 27
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C H A P T E R 6
INTEGRITY SPINAL CARE SYSTEM Medical Treatment Protocol
Summary 29
Inclusion Criteria 29
Exclusion Criteria 29
Negative Influences 30
Evaluation 30
Comprehensive History Exam 30
Comprehensive Physical Exam 31
Orthopedic Exam 31
Diagnostic Testing 32
Treatment Protocol 33
C H A P T E R 7
Performance Specifications
Performance Specifications 34
Environmental Specifications 34
Electrical Specifications 35
Regulatory Classifications 35
Electromagnetic Effects 36
C H A P T E R 8
Maintenance and Service
Routine Maintenance/ Cleaning 37
UPS 37
Cleaning 37
Transportation 38
Service Maintenance/Cleaning Log 38
Installation 39
C H A P T E R 9
Warranty
Two Warranties Offered 40
Technical Support 40
Service Calls 41
Conditions of Original Warranty 41
Use Restriction 42
Extended Warranty 42
EC Declaration 43
64-0001 Rev. D
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Introduction
Congratulations on your investment in the Integrity Spinal Care System. Integrity Life Sciences feels certain it will give you many years of service, enabling you to provide your patients with a first class modality of non-surgical treatment. The successful treatment of low back pain and neck pain without the need for surgery is achieved through decompression of the intervertebral discs and facet joints, that is, the unloading due to distraction and positioning.
Effects of Decompression Therapy The Integrity Spinal Care System provides a treatment in static, intermittent, and cyclic distraction forces to relieve pressures on structures that may be causing pain of skeletal or muscular origins. Therapeutic distraction can be applied in a variety of programmable patterns, cycles and functions.
Chapter
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Safety Information
READ THE ENTIRE SAFETY INFORMATION SECTION BEFORE OPERATING THE INTEGRITY SPINAL CARE SYSTEM.
Intended Use The Integrity Spinal Care System provides a program of treatments for relief from pain for those patients suffering with low back pain or neck pain. Each treatment consists of a physician prescribed treatment period and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back or neck pain. It relieves pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.
Patient Qualifications
All candidates for non-surgical spinal decompression, that is, the unloading due to distraction and positioning, require a thorough workup which includes a comprehensive history, complete review of systems, comprehensive physical examination, review of previous medical records, imaging, advanced diagnostics and other pertinent testing to rule out any red flags, quantify yellow flags, exclude contraindications and confirm diagnosis. Not all low back and neck pain and lower extremity symptoms are caused by conditions that originate in the lumbar spine. Non-surgical spinal decompression, that is, the unloading due to distraction and positioning, is not appropriate for everyone nor for every type of back pain and neck pain.
THE PRESENCE OF RED FLAGS, THREE OR MORE SIGNIFICANT YELLOW FLAGS OR EXCLUSION CRITERIA DISQUALIFY A CANDIDATE FROM TREATMENT
RED FLAGS: Identify those patients with emergent or serious underlying conditions such that a delay in recognition may result in death, permanent injury or disability. 1 2 3
YELLOW FLAGS: Psychosocial barriers to patient recovery and markers of known risk factors for the development of long term disability, chronic pain or persistent pain disorders. 2 3 4
Rule out any exclusionary critieria/contraindications before beginning treatment.
Chapter
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TREATMENT QUALIFICATION FOR PATIENTS WITH A HISTORY OF SPINAL SURGERY MUST COMPLY WITH ALL STANDARD INCLUSION AND EXCLUSION CRITERIA.
RELATIVE CONTRAINDICATIONS: A disease, disorder, condiditon or symptom where caution is indicated and treatment may or may not be advisable.
Prior fracture
Scoliosis
Antalgia
Perineural (Tarlov) or synovial cyst
Significant pulmonary or cardiovascular history.
Coagulopathies, the use of anti-coagulant medication or patients at risk for clot formation.
Post-surgical (spinal or non-spinal)
Shoulder, thorax, abdominal (including GI), pelvic or hip conditions
Disc calcification, end plate calcification or soft tissue calcification
Medical science is constantly changing and evolving as new research is completed and some information may become inaccurate or incomplete over time. Integrity Life Sciences has made every effort to provide up-to-date, accurate, clinical information in accordance with medically accepted practice standards at the time of disclosure. Any healthcare provider with concerns, uncertainty or additional questions should contact a clinical applications specialist directly at Integrity Life Sciences. This list is not all inclusive as it is impossible to document every possible risk for every possible medical condition which may arise. The information in this document has been provided solely for the informational purpose of the healthcare provider and should NOT be relied upon by non-professionals to make medical decisions or substitute for the consultation and advice of a licensed healthcare professional.
1 Greene G. ‘Red flags’: essential factors in recognizing serious spinal pathology. Man Ther 2001; 6: 253–5.
2 Bigos SJ. Agency for Health Care Policy and Research. Acute low back problems in adults. Rockville, Md.: U.S. Department of
Health and Human Services, U.S. Public Health Service, Agency for Health Care Policy and Research, 1994; AHCPR publication
no. 95-0642.
3 Agency for Health Care Policy and Research. Acute low back problems in adults: assessment and treatment. Quick Reference
Guide. Rockville, Md.: U.S. Public Health Service, 1994; AHCPR publication no. 95-0643.
4 Pincus T, Vlaeyen JW, Kendall NA, Von Korff MR, Kalauokalani DA, Reis S. Cognitive-behavioral therapy and psychosocial factors
in low back pain: directions for the future. Spine 2002; 27: E133–8.
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Principles of Operation
The treatment is performed by a servo-amplifier motor that has tight control over belt tension. This treatment curve ramps up to a user-defined Max Load level. The Max Load level is maintained for a duration identified as the Max Time. The tension is then lessened to the user-defined Min Load level. The Min Load level is maintained for a duration identified as the Min Time. The sum of the Max Time and the Min Time is referred to as one “cycle”. The user has the option of setting the number of cycles. The patient has the ability to stop the treatment and reduce the tension at any time. The patient’s safety is our utmost concern so we have added multiple systems to ensure that they remain safe at all times during the treatment. The patient’s safety should be the first and foremost concern to the doctor and the operator of the equipment. The patient safety switch should be tested prior to each treatment to ensure effective operation. We want to ensure the safety of your patients so we have designed and implemented the following safety system checks: 1) Handheld Patient Safety Switch 2) Medical grade isolation transformer, 3) It is recommended by the manufacturer that only a staff member that is trained and certified by Integrity Life Sciences professional operate the equipment.
All user-defined settings during the treatment are set relative to the INTEGRITY SPINAL CARE SYSTEM Treatment Protocol, which is defined in Chapter 6 of the Operator’s Manual. The default tension settings for each patient are based on the patient’s weight, which should be collected prior to each treatment. All operators of this equipment must be trained by an authorized Integrity Life Sciences Training Specialist. Once your staff has been trained, an official training certificate will be presented. This equipment should not be operated unless the operator has received both training and an authentic certificate. Caution: The Integrity Spinal Care System should only be operated by a trained professional. Any individual operating The Integrity Spinal Care System without training provided by Integrity Life Sciences would be considered misuse of the medical device and could lead to patient harm or injury. Training is to be provided only by Integrity Life Sciences Clinical Specialist. During the treatment, the tension is measured continuously. The tension matches the treatment profile submitted and monitored by the operator of the medical device. The accuracy of the measured tension is ensured through factory calibration performed during manufacturing of each machine.
The tension is displayed in pounds. The INTEGRITY SPINAL CARE SYSTEM allows a maximum tension of 150 lbs for the lumbar treatment and maximum tension for the cervical treatment is 50 lbs.
Chapter
3
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Warnings of misuse of The INTEGRITY SPINAL CARE SYSTEM
This Operators Manual and the training provided by Integrity Life Sciences contain specific instructions for operations and treatment protocol to ensure the safety of all patients that receive treatment. If the instructions and treatment protocol in this manual are not strictly followed as well as adhering to training instructions provided by the Clinical Specialist, could lead to foreseeable misuse of The INTEGRITY SPINAL CARE SYSTEM. Warnings concerning ways The INTEGRITY SPINAL CARE SYSTEM must not be used that experience has shown misuse and RISK of patient safety and RISK to the Patient:
1. The Integrity Spinal Care System should only be operated by a trained professional. Any individual operating The Integrity Spinal Care System without training provided by Integrity Life Sciences would be considered misuse of the medical device and could lead to patient harm or injury. Training is to be provided only by Integrity Life Sciences Clinical Specialist.
2. Applying non-surgical decompression to a patient that has not been qualified for the treatment. (see patient qualifications chapter 2)
3. Applying non-surgical decompression to a patient that has an existing contraindication or relative contraindication. (see contraindication chapter 2)
4. Not performing system checks: “Patient safety switch prior to treatment”. (chapter 3) 5. Improper harnessing of the patient 6. Not following “before” patient mounting procedures (chapter 5) 7. Not following the procedures for loading patient on the bed for a lumbar treatment (chapter
5) 8. Not following the procedures for attaching decompression unit belt (chapter 5) 9. Not following the procedures for attaching the upper harness (chapter 5) 10. Not following the procedures for connecting the headpiece (chapter 5) 11. The installation of The INTEGRITY SPINAL CARE SYSTEM has not been completed
by a trained Integrity Life Science technician. 12. Service NOT performed by a trained Integrity Life Science technician. 13. Not following the Medical Treatment Protocol could lead to relevant risks to the patient. 14. Not following proper patient positioning by not using the knee pillow, could lead to a relevant
risks to the patient (see chapter 4) 15. Not following the recommended MIN and MAX load could lead to relavant risks to the
patient (see chapter 5) 16. Not following the Medical Treatment Protocol and not having the patient receive a CT or
MRI could lead to a possible misdiagnosis and relevant risk to the patient. (chapter 6) 17. Not using the Integrity Life Sciences patient harness could lead to relevant risk to the
patient(see chapter 4) 18. Patients should never be left unattended when dismounting off the bed and should always use
the patient grab handles.
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Caution The INTEGRITY SPINAL CARE SYSTEM complies with the emissions and immunity requirements of EN/IEC 601-1-2. However, placing strong electrical fields near the INTEGRITY SPINAL CARE SYSTEM while it is being operated should be avoided. Examples of such devices include those with motors (i.e., vacuum cleaners) and electrosurgical generators.
Symbol Definitions Front Panel Symbols
System Reset
Treatment Pause
Side Panel Symbols
HAZARDOUS VOLTAGE. Contact may cause electric shock or burn. Turn off and lock out power before servicing.
Attention: consult accompanying documents
The operator and other persons should be aware of pinch points
Patient maximum allowed weight
Electrical and Electronic Equipment Recycling: DO NOT DISCARD unwanted equipment in the public waste disposal system. Follow ALL applicable, local regulations for storage, handling and disposal of electrical and electronic materials.
Applied Parts:Type B applied part
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Remote Symbols
Arms Up
Arms Down
Increase Lordotic Support
Decrease Lordotic Support
Tilt Bed Up
Tilt Bed Down
Slide Bed Down
Slide Bed Up
Lock Lower Bed
Unlock Lower Bed
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Explanation of the Diagnostic Monitor Panel The Diagnostic Monitor Panel displays the status of several machine parameters. Green indicators tell the operator that the function is working and ready for use. Yellow indicators caution the operator that some normal condition exists that warrants the operator’s attention. Red indicators are a warning that something has happened that requires immediate operator response. The indicators are described below:
Indicator Name Color Description
Power Green Indicates the designated motor is ON.
Motor Movement Functions (Lower, Raise, Lock, Unlock)
Green Indicates that a motor is moving.
Remote Functions (Keypress, Detected)
Green Indicates the remote is detected and communications are received by the system.
Units (Kgs / Lbs) Green Indicates the units of measure being used.
Motor Limit Sensors (Dn Limit, Up Limit, Locked, Unlocked)
Yellow Indicates that the motor has reached its mechanical limit and has been automatically stopped.
Fuse Red Indicates that the motor’s fuse is open and the motor is not operational.
Safety Switch Activated Red Indicates that the safety switch or the emergency stop has been activated.
Additionally, a green indicator is visible inside the bottom drawer on the front of the Uninterruptible Power Supply (UPS). This indicator informs the user that the UPS is receiving power and is recharging its internal batteries.
Accessories
1. Upper Harnesses 2. Lower Harnesses 3. Head Pillows 4. Knee Pillows 5. Head piece harness 6. Input power cord
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Getting Familiar with the
INTEGRITY SPINAL CARE SYSTEM
The INTEGRITY SPINAL CARE SYSTEM is rich in features for both the treatment and comfort of your patients. While undergoing treatment the patient is lying horizontally on a heavily padded leather bed complete with a Lordotic Air Pump, which is important to help target the affected disc level. The Split Table Design allows separation of the table to decrease friction and allow separation of vertebra. The Upper Body Support System allows the upper body to become comfortably positioned to the table surface. The Table Mobility has movement ranging from horizontal to vertical positions motorized by microprocessors. The Foot Platform is the platform on which the patient mounts the INTEGRITY SPINAL CARE SYSTEM. The patient is lying in a comfortable supine position while their head is cradled into the detachable headpiece. The headpiece features four interchangeable foam head supports to accommodate any size skull.
On the interface control side of things, there is a Touch Screen Computer that allows a technician to input the treatment protocol in a fast and efficient manner. The Patient Records screen allows the clinic to record daily treatment for proper patient documentation by maintaining a database of patient treatments. The Operator Remote Hand Control allows the technician easy access for controlling the various motorized adjustments on the INTEGRITY SPINAL CARE SYSTEM. The Selector Panel allows the technician to adjust the proper angle affecting specific lumbar levels for proper treatment. The Operator Remote Hand Control allows the technician easy access to settings controlling the various motorized bed adjustments prior to connecting the headpiece harness. With the aid of the Advanced Detection System, our technical department can isolate the precise cause of malfunction so an Integrity Life Sciences technician can expedite the repair process with just a phone call.
Chapter
4
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Operator Remote Hand Control Unit
A remote hand held controller is attached to the front bedside of the INTEGRITY SPINAL CARE SYSTEM and operates the functions of the various features and parameters of the motorized bed assembly. Simply press the flush mount membrane buttons on the keypad pertaining to the function you need to adjust. The upper portion of the controller has four buttons that control the Upper Body Support Arms; Left and Right, Up and Down. Below these are two buttons that control the Adjustable Lordotic Support integrated into the top cushion of the treatment table. The lower six buttons of the controller operate the Bed Position, Bed Tilt, Lock and Unlock functions.
Split Design Table
The Split Design Table consists of two cushions and provides comfort to the patient throughout the treatment. It is designed to smoothly recline from the upright access position into the horizontal treatment position.
Lordotic Air Pump
Our Lordotic Air Pump has an inflatable air bladder, which is integrated inside the top cushion of the table. This allows the lumbar spine to be supported with its natural anatomical Lordotic curvature. The air pump is adjusted by pressing the ‘Raise Lumbar Supt’ and ‘Lower Lumbar Supt’ buttons on the Operator Hand Control Unit. The operator should check throughout the treatment that the lumbar spine is supported and, if necessary, adjust using the Operator Hand Control Unit.
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Upper Body Support System
.
In order to deliver the necessary power for effective treatment, the upper half of the torso has to be anchored and stabilized and this is achieved by the use of a pair of Upper Body Support Arms (one under each armpit) in addition to the chest harness. Using the white directional arrows on the Operator Hand Control Unit, you can adjust the Upper Body Support Arms to the appropriate position so that it fits snugly into the armpit yet maintains patient comfort. The Operator Hand Control Unit moves the arms in two motions; raise and lower (as indicated by the arrows on the Operator Hand Control Unit).
Patient Safety Switch
A patient safety switch is located at the side of the bed and must be handed to the patient prior to treatment commencing. The operator shall instruct the patient that the safety switch must be held during all times of the treatment. The patient can, if he/she so wishes, discontinue treatment by pressing the safety switch. This immediately causes the tension to reduce to zero and the treatment to pause. Be aware that inadvertent pressing of the Safety Switch will cause the treatment to pause early. The operator is to test the patient safety switch one per day to ensure the ISCS functions safely and as expected at all times.
Note: The patient safety switch is essential for the functioning of the unit. If it is not connected or if it is out of order, the unit will not operate.
Foot Platform and Scale
.
The Foot Platform allows the patient to comfortably step onto the bed in the upright position and be lowered into a reclined position. The Platform Scale is a weight scale that inputs information directly into the treatment protocol. With the treatment bed in the upright position, the patient steps onto the footrest and the patient’s weight is recorded.
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Selector Panel
The tension lift control unit that adjusts the treatment angle lumbar level allows the doctor to set an angle to target a specific area of the spine. There are six different preset levels settings on the level selector panel. Simply press them with your finger just as you would any button. The preset buttons should only be considered reference points but may be used as a starting point for treatment. Specific angle adjustments should be made manually by the physician according to patient condition and response to override the preset setting. This can be performed manually by using the two override buttons on the lower portion of the selector panel. Arrows are present on the manual buttons to indicate the direction the Tension Lift Control Unit will move when the button is pressed. Note: Once the treatment has begun, both the automatic movement buttons and the manual up/down arrow buttons are disabled.
Lumbar The preset buttons are set to these values:
Lumbar Level 5 = 10 degrees
Lumbar Level 4 = 15 degrees
Lumbar Level 3 = 20 degrees
Lumbar Level 2 = 23 degrees
Lumbar Level 1 = 25 degrees
Lumbar Level 0 = 0 degrees
Cervical The preset buttons are set to these values:
Cervical Level 3 = 2 degrees
Cervical Level 4 = 4 degrees
Cervical Level 5 = 8 degrees
Cervical Level 6 = 13 degrees
Cervical Level 7 = 17 degrees
Cervical Level 0 = 0 degrees
Integrity Spinal Care Decompression Unit
The Decompression unit is the heart of the INTEGRITY SPINAL CARE SYSTEM in that it performs the actual decompression of the spine, that is, the unloading due to distraction and positioning. It is a electro-mechanical device containing a servo and its own microprocessor. The computer running the Integrity Life Sciences Treatment Software Program controls the decompression unit. This unit is not visible from the exterior of the INTEGRITY SPINAL CARE SYSTEM.
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Touch Screen Computer
The Touch Screen Computer is a user friendly Microsoft Windows™ based computer that allows the therapist to input treatment protocol in a fast and efficient manner. Upon the initialization of the INTEGRITY SPINAL CARE SYSTEM, the computer starts the Integrity Life Sciences Software and performs system diagnostics. The patient treatment information is automatically stored in a database after each treatment. The Integrity Treatment Software’s first screen is the Main Menu of six options:
Treatment > Patient information and Integrity Life Sciences Treatment Protocol parameters are entered here. The lumbar and cervical load limits shall not exceed limits input by the operator. The maximum allowable limit for the lumbar is 150 lbs and the cervica is 50 lbs.
It is the requirement of the manufacturer that the operator of the ISCS monitors the patient during treatment as the device was not designed to be an unattended therapeutic modality
New Patient > New patients can be created (or edited) here.
Patient Records > Shows a list of patient treatment sessions with the option to print out the data.
Treatment Records Shows a log of all treatments by date with the option to print out the log information. Maintenance > Brings up a sub-menu of four options.
- System Backup > performs a backup to external storage of the database and systems settings.
- System Restore > performs a restoration from external storage of the database and systems settings.
- Technical Support Information > contains technical support phone numbers and emails, and an extensive list of all system parameters.
- Import Legacy Database > performs an import of patient and treatment information from a Microsoft Access database.
- Exit > Exits to the Windows Desktop
The manner in which you interface with this touch screen computer is simple; lightly touch your finger or an eraser head to the area of the screen you want to select. There are several things to keep in mind when using the touch screen, the screen is very sensitive and will react to the slightest touch. This is sometimes a problem with accuracy of selection when selecting an area that is particularly small in size. You may find the use of other soft, non-abrasive instruments is necessary to be more accurate. Never use an object that is hard or sharp for it will cause damage to your touch screen surface.
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Patient Info LEDs
There are LED’s for the therapist and the patient to see. These LED’s display information regarding patient load and treatment parameters. They display information pertaining to the treatment’s current parameters during the patient’s treatment including current load, current cycle, current time, maximum pull load and the treatment angle. The LEDs displayed on the right side display. Red, Yellow, Green LED’s displayed on the right side displays information reflecting the patient’s weight. The green (middle) LED displays 50 percent of the patient load (weight) while the upper yellow displays 50 percent of the patient load plus 5 lbs and the lower yellow LED displays patient load minus 5 lbs. The upper red LED displays 50 percent of the patient load plus 10 lbs and the lower red LED displays patient load minus 10 lbs.
The Green LEDs displayed on the left side display information regarding various parameters of patient treatment. The upper most LED labeled ‘Current Time’ displays current time remaining in the patient treatment and counts down accordingly. The LED just below labeled ‘Current Load’ displays the pull load in pounds that the patient is experiencing at that time in the patient treatment. The LED labeled ‘Current Cycle’ displays the current cycle number that the patient is undergoing in the treatment. The LED labeled ‘Maximum Load’ displays the maximum pull load in pounds that is set in the patient treatment. The LED labeled ‘Treatment Angle’ displays the Lumbar Level in degrees that is currently set.
The LEDs displayed on the left side display information reflecting the current treatment status. The upper most LED labeled ‘Current Time’ displays current time remaining in the patient treatment and counts down accordingly. The LED just below labeled ‘Current Load’ displays the pull load in pounds that the patient is experiencing at the current time in the patient treatment. The LED labeled ‘Current Cycle’ displays the current cycle number that the patient is undergoing in the treatment. The LED labeled ‘Maximum Load’ displays the maximum pull load in pounds that is set in the patient treatment. The LED labeled ‘Treatment Angle’ displays the Lumbar Level in degrees that is currently set.
System Controls
The INTEGRITY SPINAL CARE SYSTEM powers on with a 15 Amp circuit breaker rocker switch and a System Reset button that initializes the system to power up. When necessary there is also a Computer On/Off button that resets the Treatment Computer as well as an Emergency Stop button that immediately causes the tension to reduce to zero and the treatment to pause.
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Diagnostics Panels
The Diagnostics Panel provides status indicators for primary system functions to confirm proper operation and assists our technical department to isolate the precise cause of malfunction so an Integrity Life Sciences technician can expedite the repair process in a timely fashion. The LED indicators on the Diagnostic Monitoring Panel also display indication of the Bed Position, Bed Tilt, Lower Bed Lock, Upper Body Support Up/ Down and In/Out, Treatment Positioner, Safety Switch and Remote being in use. There are also LEDs that display if one of these function has reached its maximum range of motion. Fuses protect the motors of these various functions of the INTEGRITY SPINAL CARE SYSTEM and the red fuse indicators will illuminate in the event of circuit protection.
Patient Grab Handles
The grab handles are provided to ensure patient safety and comfort when stepping on and off the bed platform. Patients should use the grab handles at all times to avoid slippage or falling and to prevent relevant risk to the patient.
Headpiece
The Headpiece comfortably cradles the patient’s head during cervical treatment. There is a detachable Foam Head Support (available in four sizes) that mounts onto the headpiece. This foam head support glides smoothly along hidden tracks, allowing the head to move slightly during treatment.
Foam Head Supports
There are four sizes of Foam Head Supports ranging from the smallest Size #1 to the largest Size #4.
Knee Support/Head Pillow
Knee Pillow
Head Pillow
A triangle-shaped under-knee rest is provided to allow for comfort and rotation of the hips. The support slides under both knees with the tension belt passing through the middle of the knee support. This specially designed pillow is provided to ensure lordotic curveature normalization. A relevant risk to the patient may occur without the use of thispillow. A small head pillow is also provided for patient comfort.
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Harnesses
There are two harnesses to be fitted onto the patient; upper and lower. They function to direct and localize the distracting effect to the disc level that needs treatment. The lower harness, which has a metal ring for connection to the decompression unit belt, is fitted around the pelvis and is referred to as the Pelvic Harness. Adjustment of the straps of the Pelvic Harness is the manner in which the harness is properly fitted to the patient. The upper harness is fitted around the chest and is referred to as the Chest Harness and is adjusted to the patient using the Velcro band. The harness kit included with the device consists of three sizes of Pelvic Harnesses: small, medium, and large, and two sizes of the Chest Harness: medium and large. Custom sizes are available; contact your sales representative for more information. Application of both harnesses must ensure patient comfort and safety at all times. Please note: This harness was designed for the non surgical decompression and specifically for the Integrity Spinal Care System. The custom designed split harness, lower and upper, distributes the load in a manner in which the forced applied to the respiratory area is evenly distributed throughout the entire torso area. The harness is fitted to the patient size and weight to prevent uneven distribution of the traction force and for comfort to the patient. The harness comes in variable sizes in order to prevent slippage or constriction during treatment. Note:improperly using this harness violates the medical protocol in chapter 6 and could cause relevant risks to a patient receiving treatment.
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Using the INTEGRITY SPINAL CARE SYSTEM
Disclaimer: In this section we will step through the various parameters and applications associated with a patient treatment procedure and explain in generalities the controls and adjustments of particular features. The information disseminated in this section is not intended to be preemptive of the INTEGRITY SPINAL CARE SYSTEM Medical Treatment Protocol discussed in Chapter 6 and should not be regarded as such. The purpose of this section is to offer the end-user reference material to be used solely as an instructional aid.
Initialize the INTEGRITY SPINAL CARE SYSTEM
Start the initialization of the INTEGRITY SPINAL CARE SYSTEM by first pressing the ON/ OFF Rocker Switch located on the bottom drawer of the system and placing it in the ‘on’ position. Wait 10 seconds after initialization before going to next step.
The next step is to power up the rest of the system by pressing the ‘System On’ button for two seconds. This step will initialize the computers and other various functions of the INTEGRITY SPINAL CARE SYSTEM and may take several minutes to complete.
Note: The system will automatically go to zero when the System ON button is pressed. This is a calibration feature that is automatically performed each time the system is powered up.
Upon initialization the INTEGRITY SPINAL CARE SYSTEM will dynamically start up the Patient Treatment Software.
Before Patient Mounts
The default tension settings for each patient are based on the patient’s weight, which should be collected prior to each treatment from the weight scale.
System automatically sets appropriate loading according to measured patient weight. The system calculates and displays 50% of the patients body weight minus 10%. The Operator must override these settings if the clinical evaluation has determined limits are not appropriate for the patient. The software does not allow the operator to exceed maximum limits. The maximum allowable limit for the lumbar is 150 lbs and for the cervical is 50 lbs.
Using the Operator Remote Hand Control Unit, the therapist should position the Upper Body Support Arms in their lowest positional setting by pressing the down arrow in the Upper Body Support section.
Chapter
5
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The therapist should ‘lock the bed’ completely together by pressing the lock button on the Operator Remote Hand Control Unit until it stops at its maximum range of motion.
The therapist should set the level according to the INTEGRITY SPINAL CARE SYSTEM
medical treatment protocol training by using the level selector on the front panel and pressing on the appropriate level button. The medical treatment protocol is described by a trained Integrity Spinal Care System specialist after purchase and installation of the system.
Harness the Patient
There are three sizes of pelvic harnesses to select from; Small, Medium and Large. Select a harness size that will best fit the patient comfortably.
Mount Patient on Foot Platform
Using the Operator Remote Hand Control Unit, press the ‘Tilt Up’ button until the maximum range of motion is reached.
Escort the patient onto the Foot Platform and have patient stand up straight instructing the patient not to lean against the bed.
Hand the patient the Patient Safety Switch while instructing the patient to be careful not to inadvertently press the button. Instruct the patient on the proper use of the Patient Safety Switch and to only use it when absolutely necessary.
At all times during the treatment, the Operator shall monitor the patient
Enter New Patient Information
With the patient still in the upright position, it is now time to enter the patient treatment information into the Integrity Treatment Software according to the Integrity Medical Treatment Protocol. If the patient has previously been entered into the database, skip this section and proceed to the Existing Patient sections.
The patient treatment screen is controlled by a large touch screen and on screen keyboard
The Integrity Life Sciences treatment software automatically starts up on the main menu screen upon initialization of the INTEGRITY SPINAL CARE SYSTEM. The first step in creating a new patient record is to select ‘New Patient’ from the main menu.
Naming Patients
The method that is used for creating names in the Patient Database is a matter of clinic preference but should be done in a way that is consistent for all patients entered so retrieving patient information is a simple process. The suggested manner of data entry is using the patient’s last name, followed by their first name. This method has proven to be simple and easy for the therapists to recall and provides consistency in data entry. For instructional reasons we will use this method in our example treatment.
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Note that the ‘Patient ID’ and ‘Comment’ usage is not a required field but an option. It is recommended that you decide upon a common standard to be used in this field as well to ensure simplicity of use.
New Patients
Tapping on any data field brings up the keyboard. After typing the desired text, click the OK button to enter the data into the data field.
New Patient Screen
Enter the patient’s name in the patient name field, last name first followed by the first name, using the keyboard on the touch screen. Commas and most other punctuation are allowed.
The Patient ID and Patient Comment fields are optional. They may be filled in now or at a later time.
The system will initially default to the MAX LOAD and MIN LOAD levels. At this time, the doctor should individualize the parameters to the patient in accordance with his / her evaluation. As the treatment parameters are changed, the Patient Loading Profile will change accordingly (however, only a few cycles are shown for clarity). The patient weight can also be set manually.
It is important that the patient be standing completely in an upright position at this point and not leaning on anything.
If desired, the MAX LOAD and MIN LOAD may be modified manually. These two values set the maximum pull value and minimum pull value, as shown in the Patient Loading Profile.
Select the desired MAX TIME, MIN TIME, and number of TREATMENT CYCLES. These values set the duration of the MAX LOAD and MIN LOAD. Note the total treatment time is shown in the TOTAL TIME box.
Click OK to add this new patient to the database.
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Selecting Existing Patients
Treatment Settings Screen
For patients already in the database, the New Patient screen can be skipped. Go directly to the treatment screen by pressing the Patient Treatment button on the Main Menu.
Click the Select Patient field at the top of the screen. A list of all patients will be shown, sorted alphabetically. Tap the desired patient name.
All previous treatment information will be recalled for that patient. Any of this information can be changed at this time.
When the desired treatment parameters have been selected, click OK. The Treatment Screen will appear.
NOTE: DO NOT PRESS “NEXT” AT THIS TIME.
You must first position patient on the treatment bed.
Load Patient on the Bed for a Lumbar Treatment
Aid the patient as they lean back against the bed cushions with the ‘Upper Body Support
Arms’ under the patient’s arms.
Adjust the ‘Bed Up/Down’ height using the Operator Remote Hand Control so the lumbar lordosis is aligned with the bladder air pump and the shoulder supports are placed under the partient’s arms.
Advise the patient to be careful not to inadvertently press the button on the Patient Safety Switch; this will disable the system.
Using the Operator Remote Hand Control by pressing the ‘Tilt DN’ buttons, lower the patient into the supine position by tilting the Treatment Bed down to the horizontal position until the Treatment Bed hits it maximum range of motion.
Insert the Head Pillow under the patient’s head with the narrow part of the pillow closest to the patient’s neck. Adjust the placement of the pillow to the patient’s own comfort.
Insert the Knee Pillow under both the patient’s knees leaving the space in the middle of the pillow open so the Decompression Unit Belt can be allowed to pass through unobstructed.
Place the Stereo headset on the patient for the CD Audio. There are volume controls on both sides of the headphones for adjustment of the volume control, which you may want to verify are set at a low level upon the start of the music playing. The patient can control the volume on the headsets on his or her own during treatment. Do not start the audio until the patient setup is complete.
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Attach Decompression Unit Belt
Position the two long straps from the Pelvic Harness through the cut out in the Knee Pillow. Attach the Decompression Unit Belt coming from the Traction Lift Unit to the Pelvic Harness by clipping the belt to the harness’ securing ring on the straps. Be careful not to pull the belt out too quickly on the Traction Lift Unit causing the Decompression Unit to disable itself. Note: The Decompression Unit Belt will retract a little after connecting to the Pelvic Harness and take up the excess slack.
Attach Upper Harness
Secure the Chest Harness to the bed using the two loose straps that are fitted in the Chest Harness at the cephalic end by passing them through the mounted buckle on the top end of the bed frame located by the head. Use the lever to remove slack from belt.
Bring the two belts of the upper harness together being careful to remove any twist or wrinkles in the belts.
Use the gray ratchet lever to rotate the metal roller. The openings of both the blue guiding prongs and metal roller should be aligned. Leave the gray ratchet lever in the open position (away from the base of the clip) as seen in the photo.
Slide the upper harness straps through the aligned openings of the blue guiding prongs and metal roller mechanism.
With the upper harness straps in place, move the gray ratcheting lever down and up repeatedly to tighten the belt to the desired tension. Continue until all slack is removed.
WARNING: BE CAREFUL NOT TO OVERTIGHTEN OR DRAW THE PATIENT UPWARD AND OUT OF POSITION.
Pull back on the upper harness straps to confirm the clip is engaged and the tension is secure and stable.
Before Mounting the Patient for a Cervical Treatment
Using the Operator Remote Hand Control Unit, the therapist should position the Integrity Spinal Care System bed in the fully down tilted position and in the fully down be position (bed parallel).
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The therapist should “lock the bed” completely together by pressing the lock button on the Operator Remote Hand Control Unit until it stops at its maximum range of motion.
The therapist should set the Cervical Level to zero by using the level selector on the icon of the computer tower prior to patient setup.
Foam Head Support Selection Take each Foam Head Support (disconnected from Headpiece) and try it for patient fit. There are four size to choose from numbered 1-4.
Foam Head Support Placement onto Headpiece Place selected foam head support sizes chosen and press down to ensure good fit onto the headpiece. Slide the headstrap through the headstrap loops, snapping on one side and Velcro on the other. Tighten only as much as the patient is comfortable.
Positioning of the Patient prior to Cervical Treatment
Use the remote to position the bed in the down position. Please be aware of the patient’s feet/leg while adjusting table position.
Attach the headpiece to the bed. The bed can be tilted up with the headpiece unit attached. The patient is invited to stand on the bed platform. The bed can be then tilted down to a fully supine position while paying close attention to the relative position of the Headpiece unit with respect to the cervical yoke.
Ensure the patient’s head is fully resting in the headpiece. The head piece must be at the fully down position, so have the patient slide down to accommodate this if necessary.
Advise the patient to be careful not to inadvertently press the button on the Patient Safety Switch; this will disable the system.
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Connecting the Headpiece ENSURE THAT THE TENSION LIFT ASSEMBLY IS AT ZERO DEGREES (0º). EXTEND THE HANDLE/ARMS OUT TOWARDS THE TOWER AFTER DEPRESSING THE ARMS LOCK BUTTON PLACE THE HANDLE INTO THE MECHANICAL HEADPIECE INTERFACE UNTIL IT IS FLUSH WITH RESPECT TO THE CERVICAL YOKE. INSERT THE LOCKING PIN INTO THE HANDLE/INTERFACE. ONCE THE HEADPIECE IS MECHANICALLY INTERFACED, THE PROPER TREATMENT ANGLE IS CHOSEN. USE EITHER THE PRESET SELECTOR CONTROL BUTTONS OR THE MANUAL ANGLE ADJUST ARROWS. NOTE: DO NOT ADJUST TREATMENT ANGLE WITH THE TENSION CABLE ATTACHED. DURING TREATMENT, THE ANGLE ADJUST FUNCTION IS DISABLED. THE TENSIONING CABLE CAN NOW BE CONNECTED TO THE HEADPIECE. PROCEED TO ENTER PATIENT DATA AND BEGIN A TREATMENT.
Fine Tuning your Lumbar Treatment
Ensure patient has been provided patient safety switch.
Raise the lumbar support to the patient’s comfort by pressing the ‘raise lumbar support’ or ‘lower lumbar support’ buttons on the operator hand control unit.
Using the Operator remote hand control unit, press the arrow buttons in the ‘upper body support’ section to adjust the upper body support arms so they fit snugly under the arm pits of the patient but not to the point of patient discomfort.
At this time the patient is completely secured and set up for treatment on the INTEGRITY SPINAL CARE SYSTEM.
Start Patient Treatment
The treatment is started on the Treatment Screen.
Verify the patient’s comfort and start the treatment session by pressing the ‘RUN’ button on the Touch Screen Computer. The INTEGRITY SPINAL CARE SYSTEM will then initiate the treatment session by first pulling up the slack in the belt and then starting the ramp up to the ‘Max Load’ pull.
The treatment may be stopped at any time by pressing the STOP button. The treatment may then be resumed by pressing the RESUME button, or quit by pressing the Exit button.
The Treatment Screen shows three informational graphs. The first is a graph of the load profile that was created for this
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patient. The second graph plots the actual force exerted on the patient (this “true force” is measured accurately by special transducers built into the decompression unit). The third graph shows the real-time adjustments being made by the INTEGRITY SPINAL CARE SYSTEM to ensure that the actual pull matches the intended profile.
Monitor the treatment and patient’s comfort and if any treatment parameters need to be adjusted, tap the “Load Adjustment” tab at the top of the screen. If appropriate, adjust the treatment parameters while min load is applied and click “Accept”. The changes will take effect on the next cycle. Discontinue treatment immediately and reevaluate if the patient experiences any discomfort.
Also during the Decompression pull, that is, the unloading due to distraction and positioning, in the first cycle the Split Table Design Table remains in the ‘Locked’ position as per the INTEGRITY SPINAL CARE SYSTEM medical treatment protocol. The pelvic harness straps may be rechecked at this time. During the first rest cycle the bed can be ‘Unlocked’ as per the INTEGRITY SPINAL CARE SYSTEM medical treatment protocol by pressing the ‘Unlock’ button on the Operator Remote Hand Control Unit or the Bed Unlock / Mattress Release button on the tower middle drawer.
Using the DVD Patient Viewing System
Basic Operation
Preparation Firstly the user should push the POWER button to turn on the DVD player.
Reset Press the reset button to reset the DVD player system. If the user wants to use the units after reset it, the POWER button should be pressed again
Mute Press this button to mute sound. Press it again to cancel this function.
Volume Adjustments Press VOL+/VOL- button to adjust sound volume
Playing Disc Pull the Middle Drawer out Insert a disc into the Disc Loading slot. The DVD player will automatically switch on. If a disc is loaded, the unit starts playing
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Eject Press the eject button to eject or load the disc. At abnormal situation, press the EJECT button for seconds to eject the disc. The user should ensure the Middle Drawer is pulled out before the EJECT function applied
Play/Pause Press the button to play a disc or to make it pause
Stop During playing, press the button one time, the DVD player memorizes the location where the user stopped (press the PLAY button to resume playing from the memorized point); Press the button again to stop playing (press PLAY button to start playing from the beginning of the disc)
Fast Reverse/Fast Forward Press the button to select fast reverse/fast forward and speed
Replacing the Remote Batteries If the operational rang of the remote control becomes short or no function while operation, replace the batteries with the new ones. Make sure the battery polarity is correct.
1- Remove the cover of the batteries 2- Replace the batteries with the new ones and make sure the polarity is correct 3- Close the cover
DVD Remote Control
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Treatment Session Complete
When the treatment session is complete, the Treatment Software will display a “Treatment Completed” message at the top of the screen. At this time the patient should be removed from the treatment bed in the sequence and manner listed below:
Lower the Upper Body Support Arms to their maximum range of motion using the Operator Remote Hand Control Unit.
Disconnect the belt coming from the Decompression Unit to the Pelvic Harness for the lumbar patients or headrest/headstrap for cervical patients in the same manner that it was connected.
Lower the Treatment Angle to Zero Degrees (cervical treatment only).
Release the Locking Pin (cervical treatment only).
Slide the Headpiece Handle / Arms back until the Finger-Depressible Locking Button snaps into the lowest finger-depression (cervical treatment only).
Remove the Stereo Headphone set from the patient.
Take the Patient Safety Switch from the patient and set it down.
Release the buckle on the treatment bed that fastens the Chest Harness. Grasp the upper harness straps in your hand. Slide the gray release button on left side of device up and HOLD. Move the ratchet handle to the closed position and HOLD. Gently slide the straps through the guiding prongs of the clip completely releasing the chest harness.
Carefully remove the Knee Pillow from under the patient in a manner that allows the patient to rest their legs on the treatment bed slowly.
Lock the treatment bed to its maximum range of motion using the Operator Remote Hand Control Unit by pressing the ‘Lock’ button.
Using the Operator Remote Hand Control Unit tilt the treatment bed up to forty five degrees and let it rest at that position for fifteen seconds to stabilize the patient by pressing the ‘Tilt Up’ button
After the fifteen seconds, continue to tilt the bed all the way up to its maximum range of motion.
Remove the Head Pillow from under the patient’s head.
Assist the patient as they step off of the Foot Platform down to the floor. The patient should never step off the platform without the assistance of the Healthcare Provider.
Ensure the patient is balanced and ask patient to take a few steps to ensure lumbar stability.
Ensure the patient holds the grab handles when dismounting before dismounting for patient stability
Remove the Chest Harness from the patient in the same manner in which the harness was placed.
Remove the Pelvic Harness from the patient in the same manner in which it was placed on.
Reset the Lumbar Level to zero using the Lumbar Selector on the front of the middle drawer.
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Click the TO: field and select the last day for which the report will be generated. Use the arrows at the top of the calendar to change the month or year.
Click the ‘Print’ button at the bottom of the screen. to save printed data folder which will be transferred and to be printed from practitioner’s stand alone computer. This will give you various parameters of the individual treatment session selected. Print Preview can be used to preview the printout.
Exit out to the Main Menu by pressing the ‘Menu’ button at the bottom of the screen.
Backing Up A Database
Maintenance Screen
The patient treatment database is backed up automatically to the computer’s hard drive daily. However, the database should also be occasionally backed up to an external storage medium to protect it from any failure of the computer system. Simply backing up once a week will prevent a significant loss of data in the unlikely event of system trouble. To perform a backup:
Select ‘Maintenance’ from the Main Menu on the Touch Screen Computer.
Place a USB drive on the right side of the Computer.
Press the ‘System Backup’ button on the touch screen.
Respond to the prompts when they appear.
A copy of the database is sent from the Integrity Life Sciences Software Program to the USB drive; this backup can be used to restore the database later in the event of system failure. Note that when performing this function, data is over written with the most recent database from the Integrity Life Sciences Software Program if you have other backups already present. Note: Integrity Life Sciences is not responsible for any loss of data that may occur in the event of system failure. Perform routine backups of your database.
Restoring A Database
In the unlikely event of a system failure, the database can be restored from the hard drive or from external storage media. To restore the database from the hard drive:
Select Maintenance from the Main Menu of the Touch Screen Computer.
Press the ‘System Restore’ button on the touch screen.
Select the most recent Date from the calendar and press the ‘OK’ button.
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To restore the database from external storage media:
Select Maintenance from the Main Menu of the Touch Screen Computer.
Place the USB drive containing the database backup on it in the USB drive on the right side of the Touch Screen Computer.
Press the ‘System Restore’ button on the touch screen.
Press the ‘Restore from disk…’ button on the touch screen.
The database that was backed up automatically to the hard drive or backed up to the USB drive prior is now restored to Integrity Software Program. Note that when performing this function the database on the Touch Screen Computer is overwritten with restored the database.
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INTEGRITY SPINAL CARE SYSTEM
Medical Treatment Protocol
Summary
As part of your purchasing the Integrity Spinal Care System, a trained medical professional will visit your location and train your staff about the treatment protocol. Your training will be extensive and include mechanical operation of your system, harness techniques and treatment protocols for both the lumbar and cervical spine. However, it is important before placing any patient on the Integrity Spinal Care System, that you check the following inclusion and exclusion criteria.
In order to determine more specific cause of LBP or neck pain, Integrity Life Sciences recommends as part of their Medical Treatment Protocol all patients receive a differential diagnosis with a CT or MRI. CT and MRI are equally accurate for diagnosing conditions that may be treated with the Integrity Spinal Care System that are caused by neck or back pain; those conditions include herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. MRI however is more sensitive and specific than other imaging tests for detecting infections or malignancies causing back pain. MRI therefore remains the current gold standard evaluation tool for diagnostic evaluation of low back or neck pain to eliminate any relevant risks or rule out any exclusionary criteria/contraindications before beginning treatment.
I. Inclusion criteria
A. Pain due to herniated and bulging discs that is more than four weeks old
B. Recurrent pain from a failed back surgery that is more than twelve months old
C. Persistent pain from degenerated discs not responding to four weeks of therapy
D. Patients available for four weeks of treatment protocol
E. Patient at least 18 years of age
F. Pain due to capsulitis of vertebral joints
G. Muscle spasm pain due to root compression.
H. History of whiplash injures.
II. Exclusion criteria
A. Pregnancy in 2nd and 3rd trimester
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B. Unstable spines
C. Recent Vertebral fractures
D. Prior lumbar fusion less than 12 month old
E. Positive Georges Test
F. Metastatic cancer
G. Severe osteoporosis
H. Spondylolisthesis (unstable)
I. Irregularities in Georges line, McGregors line or increased ADI spacing
J. Compression fracture of lumbar spine below L-1. (recent)
K. Pars defect
L. Pathologic Aortic aneurysm
M. Pelvic or abdominal cancer
N. Disc space infections
O. Severe peripheral neuropathy
P. Hemiplegia, paraplegia, or cognitive dysfunction
III. Negative influences
A. Smoking
B. Obesity
C. Medications: particularly chronic use of narcotics and steroids
D. Previous surgery which has a build up of scar tissue
E. Inadequate rest during first two weeks of therapy
IV. Evaluation
A. History
1. Comprehensive exam
2. Spinal/specific questions
a) Onset of pain
b) Decrease or increase of pain
c) Location of pain
d) Intensity
e) Physical limitations
f) Type, quality, and condition
g) Sensory symptoms
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h) Bowel, bladder, or sexual dysfunction
i) Spinal injuries
j) Spinal surgery
k) Any diagnostic study within two years (MRI, CT scan, etc.)
l) Any spinal anesthetic
m) Trigger point injections
n) Family history of back problems
o) Family history of neck problems
p) Any personal history of cancer
B. Physical Exam
1. General Exam
a) Vital signs
b) HEENT
c) Neck
d) Chest
e) Abdomen
f) Rectal
g) Skin (lesions, redness)
h) Extremities
i) Neurological exam (sensory and motor)
2. Orthopedic Exam
a) Lumbar Range of Motion
b) Cervical Range of Motion
c) Foraminal compression test
d) Cervical distraction test
e) Straight leg raising
f) Hip abduction
g) Reflexes
h) Sensory dermatomes
i) Gait and posture abnormalities
j) Muscle testing
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C. Diagnostic testing
1. Plain x-rays of the lumbar spine, including obliques and laterals within the past 6 months.
2. MRI if there is evidence of nerve root impairment.
3. Baseline CBC and differential, chemistry panel 20, ESR with 200-mm column, urine analysis, TSH.
4. EMG/NCV testing for neuritis.
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V. Treatment protocol
A. Set the angle for treatment according to physician’s evaluation including MRI findings to target certain lumbar or cervical level.
B. For lumbar patients only, set the initial weight the system automatically the weight at 50% of the body weight but we recommend 10 lbs less than half body weight or less for the first session. Being conservative is the key. If in doubt, consult Integrity Life Sciences.
C. For lumbar patients, patients will be treated for a relatively short time – 5 – n1r 30 minutes. Regimen to include two weeks of daily treatment, followed by three sessions a week as they improve for two weeks, concluding with two sessions a week until therapy is completed (individual protocol may vary with patient progress). Weight is raised in increments of 5-10 lbs per session first three sessions as tolerated in order to target one half the body weight plus 10-20 lbs.
D. For cervical patients, only during the first session the pull is systematically increased to 10% body weight (%WMP), using either Treatment Profile 1 or 2. As %WMP is increased patients should be monitored for any signs of adverse reactions. For treatments two and later pressure can be increased based on patient tolerance and comfort.
E. For cervical patients only, patients will be treated on for 5-10 minutes. Regimen to include visits three times per week for six weeks. (individual protocol may vary with patient progress). %WMP is systematically raised per session depending on patient tolerance.
F. After each treatment, the patient may receive interferential therapy and cold packs.
G. Re-exam each week or earlier to monitor patient progress. Increase or decrease pressure according to patient diagnosis, progress, and response to therapy. Multiple levels of herniations can be difficult to treat. Target primary level first and then change angle to secondary level if no improvement seen.
H. After ten treatments, patients who have improved by 50% may be instructed on different lumbar stretching exercises to be performed in conjunction with treatment.
I. For those patients who have not improved by 50% after ten treatments, consider:
1. Facet nerve block injections
2. Trigger point injections
3. Spinal adjustments
4. Refer for surgery
J. After treatment protocol or significant improvement of patient’s symptoms, patient will be put on a strengthening and rehabilitation program for about 4-6 weeks to help strengthen the paravertebral musculature. In addition, an after care program can include the use of TENS, cold packs, exercise, relaxation training, walking techniques, and posture.
K. Patient to return one month after treatment or earlier for evaluation and follow-up.
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Performance Specifications
Resolution:
Measured load (tension) 0.1 lb.
Accuracy:
Measured load (tension) 5%
Environmental Specifications Operating:
Temperature 10 – 40°C
Relative Humidity 30 – 75%RH, non-condensing
Storage:
Temperature 10 – 40°C
Relative Humidity 30 – 75%RH, non-condensing
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Measurement Range:
Measured load (tension) /Lumbar 0 - 150 lbs.
Measured load (tension) /Cervical 0 - 50 lbs.
Bed Safe Working Load 400 lbs.
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Electrical Specifications
Unit
Voltage Input (VAC) 100 / 120 / 220 V
Frequency 50 / 60 Hz
Maximum Power Consumption 600W
Supply Cord Plug An agency-approved cord appropriate for the target country will be provided.
Note:: Only plug the supply cord into a hospital-grade, voltage matched receptacle that is properly grounded and polarized.
Leakage Current Less than 500 micro amp, with power on, forward or reverse polarity
Ground resistance less than 0.1 ohm
UPS 1000VA Minimum 10 minute operation Recharge to 80% of capacity in 4.5 hours
INTEGRITY SPINAL CARE SYSTEM weight (mass)
1780 lbs. (809 kg.)
The UPS may discharge during prolonged shipment or storage times, or if the machine was disconnected from AC power for more than two months. Where possible, connect the machine to AC power when not in use for extended periods of time.
Regulatory Classifications
Type of protection against electric shock
Class I / Internal electric power source
Degree of protection against electric shock
Type B
Mode of operation Continuous
Degree of protection against ingress of liquids
Ordinary
Recommended methods of sterilization or disinfection
Refer to Maintenance chapter 8 of the INTEGRITY SPINAL CARE SYSTEM Operator’s Manual
Degree of safety of application in the presence of a flammable anesthetic
Not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen or nitrous oxide.
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Electromagnetic Effects
The device complies with the requirements of EN/IEC 60601-1-2. The following basic EMC standards were applied to verify conformance.
Environment EN/IEC 60601-1-2.
Emissions CISPR 11 Group 1, class B
Immunity EN/IEC 61000-4-2, 8kV, 6kV contact
EN/IEC 61000-4-3, 10V/m
EN/IEC 61000-4-4, 2kV power, 500V sensor cable
EN/IEC 61000-4-5, 2 kV line to earth, 1kV line to line
Symptoms of possible electromagnetic interference include sudden variations in the measured load graph or LED displays that do not correspond to patient movement or normal, expected load measurements. If interference from external sources is suspected, discontinue treatment and move suspected electrical sources farther away from the machine until the interference ceases.
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Maintenance and Service
WARNING: ELECTRIC SHOCK HAZARD: Do not disassemble the INTEGRITY SPINAL CARE SYSTEM. There are no user-serviceable items inside the machine. Contact Integrity Life Sciences for service. NOTE: If any of the motor fuse lights appear, any indicators appear unexpectedly, or other unexpected operations occur, discontinue use and contact Integrity Life Sciences Technical Support immediately.
Routine Maintenance / Cleaning UPS The machine contains an Uninterruptible Power Supply (UPS) that maintains power to the machine during glitches in building power. This UPS contains a battery that is continually recharged during normal use. The INTEGRITY SPINAL CARE SYSTEM is shipped with the UPS battery fully charged.
Cleaning
There are various types of surface areas on the INTEGRITY SPINAL CARE SYSTEM that require a minimal amount of cleaning to maintain them. Integrity Life Sciences recommends that you periodically clean these surfaces with the recommended cleaning methods to maintain the INTEGRITY SPINAL CARE SYSTEM. Use cleaning solution sparingly. Never use abrasives or products containing bleach. Clean the surfaces according to the following:
Leather – Remove surface soiling from leather with a soapy sponge and then wipe with a clean damp cloth. Condition and treat leather with a quality leather cleaner and conditioner to prevent cracking and preserve flexibility.
Front Panel Screens – Clean front panel screens with a clean soft cloth very lightly moistened with water, being careful not to allow excess water to leak from the cloth. Do not touch, press, or rub the INTEGRITY SPINAL CARE SYSTEM™’s display panels or front keypad panel with abrasive cleaning compounds, instruments, brushes or rough surface materials.
Monitor Screen – Clean monitor screen with a clean soft cloth very lightly moistened with water, being careful not to allow excess water to leak from the cloth.
All Painted Surfaces and Floor Plates – Clean all painted surfaces with a soft cloth dampened with a mild detergent and water mix.
Mattress and Pillows – Clean mattress and pillows with a soft cloth dampened with a mild detergent and water mix between sessions. Do not use any solvents. Rinse thoroughly before next patient application.
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ALL INTEGRITY SPINAL CARE SYSTEM SYSTEMS SHOULD BE INSPECTED BY AN AUTHORIZED FACTORY TECHNICIAN AFTER THE FIRST YEAR OF USE TO CONDUCT CALIBRATION PROCEDURES, MOTOR FUNCTION ASSESSMENTS, ELECTRONIC LOAD ASSESSMENTS AND OTHER PREVENTATIVE MAINTAINENCE TASKS. THIS MAINTENANCE VISIT IS NOT COVERED BY WARRANTY AND IS AT THE EXPENSE OF THE OWNER/ LESSEE. IF AN INTEGRITY TECHNICIAN SERVICES THE INTEGRITY SPINAL CARE SYSTEM AT ANY TIME, THIS SERVICE MAY HAVE ALREADY BEEN PERFORMED. CONTACT THE FACTORY FOR MORE INFORMATION AND DETAILS.
Transportation of the INTEGRITY SPINAL CARE SYSTEM
The INTEGRITY SPINAL CARE SYSTEM is a complex, sensitive medical device. Any transportation of the machine should be performed by Integrity Life Sciences or trained representatives of this organization; doing otherwise will void the warranty. Refer to the product warranty for more information. Instructions fir safe manual handling of the system are only provided for a trained technician of Integrity Life Sciences. The system is not intended to be moved by an untrained person(s) and if transported or moved and reassembled without proper training could be considered misuse of the system and possibly put patients at risk.
Service Maintenance / Cleaning Log Maintain an accurate record of all service calls, visits and routine maintenance performed on machine. Present this log to Integrity service technician upon arrival; failure to maintain this log could void your warranty.
Service Date
Technician Servicing
Service Order # Technician Notes
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The Integrity Spinal Care System can only have service and maintenance performed by an authorized Integrity Life Sciences trained professional. Anyone who does not have a certificate that indicates a factory authorized trained professional should not be permitted to service or perform maintenance on the Integrity Spinal Care System. This Integrity Spinal Care system was not intended to be serviced or performed maintenance by a non-professional or consumer. The drawings, diagrams, descriptions and explanations necessary for the use, maintenance and repair of the machinery and for its correct functioning are proprietary and confidential information. A separate maintenance manual have been developed for trained authorized Integrity Life Sciences technicians.
Installation of the INTEGRITY SPINAL CARE SYSTEM The Integrity Spinal Care System is not intended to be installed by any persons that have not been trained to install the system. Only those individual(s) that have been trained by Integrity Life Sciences have the required training for safe installation of the system. Any person(s) that have installed the Integrity Spinal Care System and has not been trained by Integrity Life Science could cause foreseeable misuse of the equipment and will void any and all warranties.
For safe operation and serviceability of The INTEGRITY SPINAL CARE SYSTEM the space requirements for is no smaller than a room size of 10 x 12.
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Warranty
Two Warranties Offered
Integrity Life Sciences offers two types of warranties with the INTEGRITY SPINAL CARE SYSTEM, an Original Warranty with the purchase of a new machine, and an Extended Warranty which is purchased at least 30 days prior to the Original Warranty expiration. The Manufacturer represent, covenants and expressly warrants that any product shall be free of defects in materials and workmanship and will perform for the purpose for which it is designated, when used under normal conditions, and when installed, calibrated and operated in the manner prescribed in this manual.
For a period of one year from the date of the original installation, the Manufacturer will replace or repair any part of the equipment that fails because of a manufacturer defect or workmanship. The Manufacturer will provide the Replacement Part to, or repairs at, the site of the original installation.
The Manufacturer reserves the right to make changes to any of the specifications of the product without prior notification to prospective buyers. If the manufacturer makes changes to: fix software bugs or repair defects to machine, the manufacturer will make these changes at manufacturer’s expense to systems already installed by manufacturer. However, Integrity Life Sciences is constantly working on research and development to ensure that practitioners have the most modern technology available to date. These changes enhance equipment performance and may contain features not available on prior models of the INTEGRITY SPINAL CARE SYSTEM but are not considered to be warranty repairs or free upgrades. Many of these enhancements are available for purchase as a system upgrade. Contact your salesperson for more details.
Technical Support
Integrity Life Sciences is committed to providing practitioners complete support, encompassing clinical, technical, and marketing components. Our goal is to provide the products and services that will help your practice thrive with today's advancing medical technology. In the unlikely case that you experience any problems with the INTEGRITY SPINAL CARE SYSTEM or just need some assistance, technical support can be reached at 813-935-5500. Though all of our technicians carry cell phones for close communication with our valued customers they are servicing, please call either our toll free number or main number at 001-813-935-5500 for fast, efficient service when you need any technical support. A knowledgeable technician will be available to support you and answer all your questions. It is important that you communicate any and all problems or questions you have with the technician at this time so that if a technician is dispatched, he or she is fully prepared to address all your needs. Failure to do so could result in the inability to perform all tasks necessary to complete the service and/or charges may be applied even for warranty service.
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Service Calls
Should you require a service call for any repairs, maintenance or upgrades, Integrity Life Sciences will always make every exhaustive effort, within reason, to co-ordinate with your scheduling needs. Integrity will always prioritize the dispatching of technicians according to the nature of and severity of the problem. So that all our valued customers receive the same level of fast efficient service, it is expected that prior arranged service calls are performed at their scheduled times as mutually agreed or charges may be applied, even for warranty services.
Conditions of Original Warranty
The electrical power source for the operation of the INTEGRITY SPINAL CARE SYSTEM must be a dedicated 15-amp circuit. Operation of the equipment connected to electrical circuits to which other equipment is also connected can result in faulty operation and damage and will void the warranty. The installation technician is in no way responsible for determining circuit compliance or proper wiring.
This warranty covers normal labor costs involved in the repair or replacement of defective parts, and travel costs involved in diagnostic calls or in servicing or replacement parts. The warranty does not cover replacement of chest and pelvic harnesses, knee rest, head pillow, arm supports or the bed mattress, head straps or head foam support
The terms and conditions of the Standard and the Extended Warranty require that all routine maintenance procedures as set out in the Manual are performed as required and that all repairs, modifications, alterations and/or changes in the INTEGRITY SPINAL CARE SYSTEM shall be made according to the manufacturer specifications only by qualified INTEGRITY SPINAL CARE SYSTEM technicians and/ or authorized agents of manufacturer or distributor/ user. A form to record routine maintenance procedures and service calls shall be provided as part of this manual.
Should the Equipment become damaged or inoperative due to abuse, improper usage, tampering, attempt to repair by unauthorized technician, improper handling or care, the warranty does not apply. The Warranty shall not be voided, if trained representatives, of the Manufacturer or the Distributor, move the equipment in any way whatsoever from its exact initial installation location. CONVERSELY THE WARRANTY SHALL BE VOID IF THE EQUIPMENT IS MOVED IN ANY WAY WHATSOEVER FROM ITS EXACT INITIAL INSTALLATION BY SOMEONE OTHER THAN TRAINED REPRESENTATIVES OF THE MANUFACTURER OR THE DISTRIBUTOR.
The Manufacturer shall not be liable for the default or delay in performance under its warranties, if its default or delay is caused by any act of God, fire, natural disaster, or act of government; provided that the manufacturer gives the operator written or verbal notice thereof promptly upon discovery thereof and uses its best efforts to cure the delay or default.
DISCLAIMER: MANUFACTURER, AT ITS OWN DISCRETION, WILL DETERMINE IF A REPAIR CAN BE PERFORMED BY THE OPERATOR/ BUYER WITH REPLACEMENT PARTS VIA OVERNIGHT DELIVERY. MANUFACTURER WARRANTY REQUIRES OPERATOR/ BUYER TO PERFORM SIMPLE INSTALLATIONS WITH THE DIRECTION FROM MANUFACTURER. MANUFACTURER WILL MAKE EVERY EFFORT TO
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DISPATCH A TECHNICIAN AS QUICKLY AS WORK AND TRAVEL SCHEDULES ALLOW IN THE EVENT AN ONSITE REPAIR IS NEEDED.
Use Restriction
As the Purchaser, you may physically transfer the INTEGRITY SPINAL CARE SYSTEM™ from one location to another (with the assistance of an authorized technician) provided that the software/firmware is not copied, disclosed, or distributed to others or to any other device. The INTEGRITY SPINAL CARE SYSTEM™ device and software/firmware is licensed to the Purchaser, and may not be transferred, leased or sold to anyone without the prior written consent of Integrity Life Sciences.
Extended Warranty
Integrity Life Sciences offers an extended warranty on the INTEGRITY SPINAL CARE SYSTEM that extends coverage on all parts and labor for up to two (2) years on any INTEGRITY SPINAL CARE SYSTEM that was purchased new, excluding airfare and all travel expenses incurred. THE EXTENDED WARRANTY MUST BE PURCHASED AT LEAST 30 DAYS PRIOR TO ORIGINAL WARRANTY EXPIRING.
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EC DECLARATION OF CONFORMITY (In accordance with EN 45014)
Manufacturer: Integrity Life Sciences 2189 West Bush Blvd, Tampa, FL 33612 www.integritylifesciences.com TEL: (813) 935-5500 FAX: (813) 935-5505 Type Of Equipment: Powered Traction Product Model ISCS Trade Name: Integrity Spinal Care System Scope of Application: Serial Number ISCS--0001 through ISCS--XXXX Class IIA
We, hereby declare that the above mentioned device complies with the European Medical Device Directive 93/42/EEC and are in accordance with Annex II.3 without chapter 4 of the EEC Directive, supported by the Conformity Assessment Procedure and adhering to the essential requirements in accordance with Annex 1 of the European Medical Device Directive 93/42/EEC. The equipment which accompanies this declaration is in conformity with EU Directive(s):- 93/42/EEC –Annex II without chapter 4- Medical Device Directive
Let it be known that Integrity Life Sciences is exclusively responsible for this Declaration of Conformity.
EC Representative: Notified Body MDSS GmbH TUV SUD Product Service GmbH (0123) Schiffgraben 41 Riddlestrasse 65 30175 Hannover 80339 Munich Germany Germany EC Certificate # QN 1N 12 02 77975 001 G1 23 02 77975 0002
Date of Issue: 4/2/2012
Place of Issue: Munich Germany Signature: James J. Gibson, Jr. 2189 West Bush Blvd Tampa, Florida 33612
