UPTC SpineMED S200U Quick start guide

ADVANCED MEDICAL TECHNOLOGY
Model S200U/S200UC
OPERATIONAL INSTRUCTION MANUAL
Serial No.: Table: # ___________________
Serial No.: Cervical: # _________________
Copyright © 2020 Universal Pain Technology Canada Inc. All rights reserved.
SpineMED® Patent #7201729
UPTC-WI-093 (U-Series)
v1.6
December 15, 2021

WI-093 v1.6ii
Table of Contents
Introduction to Universal Pain Technology Canada and the SpineMED® ....................................................1
1. Therapeutic Guidelines and Protocol.................................................................................................3
1.1 Review of Underlying Principles of the SpineMED® Procedure...........................................3
1.2 Indications and Contraindications for Patients of SpineMED® Procedure ...........................3
1.3 Guidelines for Patient Selection for SpineMED® Procedure ................................................4
1.4 Patient Instruction Prior to Undergoing the SpineMED® Procedure.....................................6
1.5 Standard Protocol for the SpineMED® Procedure................................................................6
1.6 Procedure Algorithm and Flowchart for SpineMED® Procedure........................................11
1.7 Recommended Adjuncts to the SpineMED® Procedure.....................................................12
1.8 Patient DO and DON’T........................................................................................................12
1.9 Post SpineMED® Procedure Protocol.................................................................................13
2. Description of the SpineMED® System S200U/S200UC.................................................................14
2.1 Intended Use of the SpineMED®........................................................................................14
2.2 Structural Design – Components and Features of the SpineMED® S200U/S200UC........15
2.3 Details of Individual Components of the SpineMED® System............................................17
2.4 Operational Design..............................................................................................................22
2.5 Accessories.........................................................................................................................24
2.6 Installation and Space Requirements..................................................................................24
2.7 SpineMED® Power On Procedure......................................................................................26
2.8 SpineMED® Shutdown Procedure......................................................................................27
3. SpineMED® Software Operation.......................................................................................................28
3.1 Operator Logon Screen.......................................................................................................28
3.2 Main Menu...........................................................................................................................29
3.3 Administration Menu Screen...............................................................................................31
3.4 Patients Menu Screen.........................................................................................................32
3.5 Physician Menu Screen.......................................................................................................36
3.6 Users Menu .........................................................................................................................40
3.7 Database Management.......................................................................................................42
3.8 Logout/Exit...........................................................................................................................44
1.3.1 Contraindications.............................................................................................................5
3.4.1 Enter New Patient .........................................................................................................32
3.4.2 Modify Existing Patient’s Information............................................................................
34
3.4.3 Archive or Restore Existing Patient Record..................................................................34
3.5.1 Enter New Physician.....................................................................................................36
3.5.2 Edit Existing Physician’s Information ............................................................................
37
3.5.3 Physician’s Info Report .................................................................................................
38
3.5.4Physician’s List Report..................................................................................................39
3.6.1 Enter New User.............................................................................................................41
3.6.2 Edit Existing User’s Information....................................................................................42
3.7.1 Backup Database..........................................................................................................42
3.7.2 Restore Database .........................................................................................................
43
3.7.3 Export Database............................................................................................................44

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4. Lumbar & Cervical Procedure Screens............................................................................................44
4.1 Lumbar Procedure Screen ..................................................................................................44
4.2 Cervical Procedure Screen .................................................................................................50
4.3 Reports Menu Screen..........................................................................................................57
4.4 Selecting Patient Data.........................................................................................................57
4.5 Report Options ....................................................................................................................59
5. Procedure Session .............................................................................................................................64
5.1 Review of Individual Modalities of Each Session................................................................64
5.2 Data Entry for Lumbar Session...........................................................................................65
5.3 Data Entry for Cervical Session ..........................................................................................66
5.4 Instructions and Sequencing for Patient Set-up for Lumbar Session .................................67
5.5 Instructions and Sequencing for Patient Set-up for Cervical Session.................................72
6. Therapeutic Operational Guidelines.................................................................................................74
6.1 Outcome Measure Data Entry.............................................................................................74
7. Precautions .........................................................................................................................................75
7.1 Precautions for SpineMED® Procedure..............................................................................75
7.2 Precautions for Use of SpineMED® System.......................................................................75
7.3 Degree of Protection Against Harmful Ingress of Liquids: IPX0 (ordinary equipment)......76
7.4 Environmental Conditions for the Operation, Storage and Transport of the SpineMED®..76
8. Maintenance........................................................................................................................................77
8.1 Disposal of SpineMED® System.........................................................................................77
8.2 Regular Maintenance ..........................................................................................................77
8.3 Cleaning of Equipment........................................................................................................77
8.4 Service and Warranty..........................................................................................................78
8.5 Troubleshooting...................................................................................................................79
8.6 Power Troubleshooting and Fuse Replacement.................................................................80
9. Technical Specifications....................................................................................................................84
9.1 Power Supply ......................................................................................................................84
9.2 Dimensions and Weight.......................................................................................................85
9.3 Model Number Designation.................................................................................................85
9.4 Type B Applied Parts...........................................................................................................85
9.5 Compliance Standards........................................................................................................86
9.6 Degree of Accuracy.............................................................................................................90
10. Manufacturer.......................................................................................................................................91
10.1 Contact Information.............................................................................................................91
10.2 European Union Authorized Representative.......................................................................91
10.3 Notified Body .......................................................................................................................91
10.4 CE Mark and Notified Body Number ...................................................................................91
10.5 Product Serial Label Examples ...........................................................................................92
APPENDIX..........................................................................................................................................................93
Device Classification........................................................................................................................93
Definition of Symbols.......................................................................................................................93
Warranty Certificate.........................................................................................................................94
4.5.1 Session Report..............................................................................................................59
4.5.2 Daily Progress Report...................................................................................................
60
4.5.3 Patient Full Report.........................................................................................................
62
4.5.4 Procedure Report..........................................................................................................63
8.6.1 Power Troubleshooting .................................................................................................80
8.6.2 Fuse Inspection.............................................................................................................83
9.5.1 Electromagnetic Standards EN 60601-1-2 2015 ..........................................................86
9.5.2 Electromagnetic Environment Guidance.......................................................................
87
9.5.3 Compliance Standards Met...........................................................................................90

Introduction to Universal Pain Technology Canada and the SpineMED®
For the past 20 years, health care clinics throughout the world have been able to deliver a non-
invasive procedure for pain as a result of herniated, bulging, degenerative discs, facet
syndrome and failed back surgery. This non-surgical decompression* of discs has been shown
to be effective in reducing pain and improving the functional activity levels of patients.
Fortunately, the collection of experiences during this lengthy clinical history, now provide a
solid foundation for the improvements in the design and application of disc decompression.
Universal Pain Technology Canada was formed by a group of professionals from North America,
whose years of experience with non-surgical disc decompression systems is unprecedented.
Since the 1980s, this group has been engaged in delivering and reviewing the results of
decompression and patient satisfaction. Recognition of the continued benefit of this procedure for
the patients, has served as motivation to work diligently on the engineering and manufacture of an
enhanced disc decompression device and the development of an effective procedure protocol.
The SpineMED® System (S200U/S200UC) that is now in your possession is the new generation
decompression system by Universal Pain Technology Canada. The advances made have
culminated in a simplified, comfortable and efficient method of stabilizing the patient during
decompression while providing an accurate method of spinal joint distraction. In partnership with
the clinicians, the Universal Pain Technology Canada team has established a protocol that gives
the most consistent and reproducible effectiveness possible with disc decompression available
today. Together the technology and the knowledge of application create the SpineMED® System.
In the history of the manufacturing of medical technology, it has been demonstrated that the
effectiveness of a device is only a part of the procedure. How the professional uses the technology
is crucial to its success. It is the belief of UPTC that the delivery of a standardized system of
training and support is an integral part of the SpineMED® System and ensures the best possible
outcomes.
Initial training, online education and support are provided in the set-up and continue throughout the
operational phase of the S200U/S200UC. Monitoring of the sessions, acts as a means of
continuous quality control. During the learning stage, the use of a method of standardized data
collection allows for the SpineMED® coordinator to view at any time a patient’s procedure plan and
outcome. Any changes required are offered to the clinician by direct feedback or via e-mail. Upon
completion of the training and testing, certification for use of the S200U/S200UC is issued to the
professional Operator.
Universal Pain Technology Canada and its established network of resources will continuously
strive to provide the clinicians and the patients with the resources required to attain maximum
effectiveness, patient comfort, safety and efficiency of use for the clinician. Ongoing clinical studies
and customer feedback will provide the knowledge for necessary changes in the future.
This manual will serve as a guide for the health professionals who will be using the
SpineMED® System (S200U/S200UC) and the SpineMED® Protocol for the Lumbar
and Cervical Spine. It is important that every Clinician and Operator of the SpineMED®
System read all of the instructions and warnings contained in this Manual, prior to
operation of the SpineMED® System.
*Spinal Decompression that is, unloading due to non-surgical distraction and positioning.

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CAUTION: FEDERALLAW (CANADA/USA) RESTRICTS THIS DEVICETOUSE BYOR
ON ORDER OF A PHYSICIAN, CHIROPRACTOR, PHYSICAL THERAPIST OR
PRACTITIONER LICENSED TO USE THIS DEVICE. THIS EQUIPMENT MUST BE
OPERATED/UTILIZED UNDER THE DIRECT SUPERVISION OF A LICENSED
HEALTHCARE PRACTITIONER.

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1. Therapeutic Guidelines and Protocol
1.1 Review of Underlying Principles of the SpineMED® Procedure
To be competent as clinicians working with the SpineMED® System,
it is essential to know the functional anatomy of the spine and the
surrounding tissues. This portion of the manual will serve to
highlight the principles that are significant to the delivery of
SpineMED® Decompression. The more detailed review of the
material required for learning will take place during the training
sessions once your SpineMED® System is installed. It is
recommended by UPTC that clinicians be trained and certified prior to
treatment of patients with the SpineMED® System.
The knowledge of how a normal disc operates as a shock absorber, how it remains
healthy, and, how it behaves under immense pressure, will provide you with the
foundation of the SpineMED® protocol. This information describes how the benefits of
the design of this particular system and the protocol for disc decompression; ultimately
provide pain relief for the patient.
The evolution of disc decompression has taken place over a long period of time, and
after a great deal of investigation. The scientific reference articles and studies are
strongly recommended, and are found in the Clinic Resource CD. Optimal effectiveness
is quickly reproducible when there is a consistency and accuracy in the application
technique with each patient. There is a routine that must be followed and not varied
with each patient. Although certain patients will require modification in the delivery of
the distraction, the basic principles apply. During the training and learning stage, careful
review of the results of each patient with an experienced Universal Pain Technology
Canada professional is extremely valuable.
1.2 Indications and Contraindications for Patients of SpineMED® Procedure
A) The Indications
SpineMED® is an inherently safe procedure; however, it must be performed on a spinal
column that is anatomically structurally stable. The standardized medical and
physiotherapy assessments completed prior to the patient entering into the procedure
provide the screening necessary for confirming the condition of the spine. It is strongly
recommended that prior to the SpineMED® procedure, the patient have the results of a
current spinal X-Ray (i.e. no less than 3 months old). If there are recent MRI or CAT
Scan diagnostics available, then it is up to the Clinician whether an x-ray is essential.
B) Candidates
a. The patient presenting with clinical and/ or radiological evidence of a herniated, bulging
or degenerative disc is ideal.

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b. The patient clinically presenting with buttock, leg and foot pain as a result of Lumbar
spinal dysfunction, or shoulder, arm and hand pain as a result of Cervical spinal
dysfunction.
c. The patient presenting with classic nerve root involvement of Sciatica Radiculopathy.
d. Patients with lateral Stenosis and central Stenosis, if severe secondary changes are not
present in the Vertebra and if the Stenosis is not due to a structurally narrow spinal
canal.
e. Patients presenting with a pain pattern and clinically findings suggestive of Facet
Syndrome.
f. Patients who have failed back surgery.
1.3 Guidelines for Patient Selection for SpineMED® Procedure
A) The maximum patient weight safe working load is 325 lbs. (147 Kg.).
B) Patients with lateral Stenosis and central Stenosis may respond if severe secondary
changes are not present in the Vertebra. The definition of Stenosis also becomes an
issue. When the diagnosis of Stenosis results from an actual structural narrowing of the
spinal canal, in this situation, positive results are less likely. However, if the diagnosis is
present as a result of disc bulge, positive results can be expected.
C) The SpineMED® can be used post spinal surgery and following failed spinal surgery.
The use of SpineMED® in conjunction with percutaneous Discectomy is not
contraindicated. Clinical trials have demonstrated that the dual approach seems to offer
an advantage especially in those patients who have more than one level of disc
herniation in which only the major segment was percutaneously excised.
Patients with a history of previous Laminectomy may undergo the SpineMED®
procedure when the extent of surgical excision has not compromised the Vertebral
articulations and ligamental structures. The guideline is that previous surgery is not
contraindicated unless there is hardware; i.e. wire mesh, screws, rods, etc., that have
been implanted in the spine. The procedure can be undertaken after 6 to 12 months
following the removal of the hardware to allow complete healing. The health care
professional and the Doctor will assess the time frame.
D) A patient with recurrent back or neck pain with little to no clinical findings presents a
challenge and often becomes a chronic pain patient with secondary gain issues. If the
patient continues to be motivated to alleviate the pain and does not want to continue on
with the use of pain medication, SpineMED® is a choice that can be presented to the
patient. The success rate with these patients is surprisingly high.
E) Although not a contra-indication, it is important to know if a patient is on narcotics for
pain relief prior to undergoing the procedure. A patient who has a long history of using
narcotics will be unable to accurately report a response to the procedure, and
depending on the drug, the patient is at risk for experiencing rebound pain.

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F) It is necessary for patients with a history of narcotic use, to first discontinue narcotic
medication prior to beginning the procedure. If the patient has been on narcotics for a
short time and requires strong medication because of the pain level, the SpineMED®
procedure can begin while still taking narcotics for pain. In this scenario, the narcotic
use should be closely monitored and curtailed as quickly as possible.
1.3.1 Contraindications
The SpineMED® Procedure should not be administered if any of the following
apply to the patient:
A) Pathological lesions or congenital deformities of the Vertebral column that disrupt the
integrity and stability of the Vertebral and ligamental structures.
B) Fractures; i.e. compression fractures within one year.
C) Patients with lateral Stenosis and central Stenosis may respond if severe secondary
changes are not present in the Vertebra.
D) Neoplasm, spinal tumors; both metastasis and primary.
E) Spina Bifida or Pars Defect.
F) Spondylolisthesis Grade 2 and greater.
G) Osteoporosis with more than 45% bone loss.
H) Progressive pathological or inflammatory process of the spinal joints or muscles.
I) Inflammatory diseases involving the Spine; i.e. Active Rheumatoid Arthritis or
Ankylosing Spondylitis.
J) Connective tissue disease; i.e. Scleroderma.
K) Cauda Equina Syndrome, which is a result of pressure on the Cauda Equina, presenting
with bowel and bladder dysfunction.
L) Post-surgical patient with hardware implants, including, but not limited to; rods, screw,
metal mesh implants in the spine.
M) Post-surgical patients who have had spinal surgery and healing of tissue is still required.
(The period of time post spinal surgery will vary between 6 months to a year).
N) Pregnancy
O) Patients under 15 years of age.

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1.4 Patient Instruction Prior to Undergoing the SpineMED® Procedure
Patients are instructed to read the Patient Handbook and to speak to the Clinician about
any questions or concerns. It is highly recommended that a patient completes a clinic
visit and observe the session in progress, if possible.
The patient must have available for their use an acceptable Lumbar support that they
must bring with them to the first session. The support serves primarily to prevent the
patient from participating in movements or activity, which will have a negative effect on
the healing that is taking place, and to offer some support to the Lumbar Spine. All
patients undergoing the SpineMED® procedure are advised to wear a Pelvic Support
Belt following each SpineMED® session. This is especially important if the patient must
travel any distance or may be subject to acceleration or deceleration forces in transit.
Pelvic Belts should also be worn when any postural strain is felt or anticipated as well as
whenever the patient engages in activities that may invoke Lumbar flexion or rotational
movements during the period of time, they are on a course of SpineMED® sessions.
Also, many patients find that wearing a Pelvic Support Belt, especially after a
SpineMED® session, adds to their comfort level and assists them in maintaining a
regular regime of sessions, further facilitating their recovery.
The patient is told that the commitment to the procedure is vitally important and that
participation in strenuous activities and exercise during this time of healing will have a
definite negative effect upon the results of the procedure. There cannot be enough
encouragement given to the patient to comply too the suggested protocol and the “DO”
and “DON’T” instructions contained in the Patient Handbook. It is their part of the
program, which will have a direct effect on the outcome of the program. Patients are
asked to consider this as a time of healing like one would following an injury to any joint.
Sessions are administered with patients fully clothed. However, comfortable, two-piece
clothing that can be separated at the waist and loosened at the wrist would be the most
practical and comfortable. To avoid bending immediately after each session, it is
advisable to wear shoes that slip-on, rather than lace up.
1.5 Standard Protocol for the SpineMED® Procedure
A) Completion of medical screening and review of previous medical records and
radiological reports. Minimal requirement is an X-Ray taken no longer than 3 months
ago. The Medical Screening Form and radiological records must be faxed or sent to the
SpineMED® Clinic, prior to the patient commencing the procedure.
B) The patient must review the Patient Handbook prior to beginning the procedure and is
encouraged to have any concerns dealt with prior to the sessions starting.
C) The patient will require a minimum of 20 sessions, which are administered daily, for a
minimum of 5 days each week. With each session, there is a cumulative effect. Each
SpineMED® session takes approximately 30 minutes, with total time for the session
taking 60 to 90 minutes, inclusive of adjunct modalities.
D) The clinician reviews the Medical Screening Form, medical records and radiological
report at the first session. A standardized Physical Therapy Assessment is then

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completed. It is important to review all the clinical information and confirm the patient is
an appropriate candidate.
E) Maximum Tension is calculated based on the patient’s body weight. Starting Tensions
should be 10% of Body weight (*i.e. 160 lb. X 10% = 16 lb.). Gradual increase of
distraction forces is based on the patient’s pain response to the session plus the general
guideline of 3-5 lbs./session. If the patient becomes sore following a session, then the
tensions must be reduced. The sessions should never result in the patient being sore,
centrally above S1 in the low back. Typically, patients will require and find a
comfortable plateau between 10% and 13% of body weight for Lumbar sessions.
Typically, the maximum distraction tension of 15% of body weight is applicable to all
patients and it is rare to exceed the 15% of body weight. The SpineMED® will enter the
calculated Maximum Tension for the first session; however, the Operator can modify
this value. Software will prevent User from entering Maximum Tensions above 25% of
body weight.
F) The SpineMED® software will alert the Operator in the event that they attempt to
increase the Maximum Tension beyond 15% of body weight. The following message
will appear, to confirm that the Operator does wish to exceed the typical protocol:
The SpineMED® software will also prevent the Operator from exceeding the maximum
recommended tensions for the patient being treated. If the Operator attempts to exceed
25% of body weight for a patient, the following error message will appear: