Hill Laboratories HF54 Plus User manual

HF54 Plus • Instructions for Use
Including Instructions for Use for Horizon (HF023) IR Light Probe
Rx ONLY
Document No: 16-00104
Version: 06
Revised: January 2019
PRESCRIPTION USE STATEMENT
Caution: Federal law restricts this device to sale by or on the order of a practitioner licensed
by the law of the State in which he/she practices to use or order the use of the device.

HF54 PLUS Operating Instructions Page 1of 60 January 2019
LIMITED WARRANTY
The HF54 is warranted to be free from defects in material and workmanship. A 1 year limited warranty goes
into effect from the date of invoice. The warranty covers the generator and applicator(s). All accessory parts
have a 90-day warranty.
Hill Laboratories agree to repair, at the point of manufacture, without charge, all parts showing such defects,
provided the generator is delivered to us, intact for our examination, with all transportation charges prepaid,
and provided such examination discloses in our final judgment that the generator is defective.
The warranty will only be honored if the registration form below is filled out and returned to us within 30 days
of purchase by FAX or mail. The FAX number to use is [phone].
The warranty is void if the equipment has been subject to misuse, neglect, accident, incorrect wiring (not our
own), improper installation, or put to use in violation of instructions furnished by us; has been damaged by
excess voltage; has been repaired or altered outside our factory, other than a authorized-factory
representative, or has had a serial number altered or removed.
This warranty supersedes all other warranties expressed or implied including the warranties of
merchantability and fitness for use and of all other obligations or liabilities on our part, and Hill Laboratories
shall not be held liable or responsible for any other liability in connection with the sale or use of this
equipment. In no event, shall we be liable for consequential or special damages arising from breach of
warranty, breach of contract and negligence. Hill Laboratories makes no warranty whatsoever in respect to
accessories or parts not supplied by Hill Laboratories.
REGISTRATION
Copy the registration form below and fill it in. Send either by mail or fax to the mailing address
or Fax number given. Keep a copy for your records.
REGISTRATION FORM
Attn: Registration Dept Fax to: [phone]
Hill Laboratories Co.
P O Box 2028
Frazer
PA 19355
USA
Facility Name:
Contact person:
Street Address:
City:
State/Province:
ZIP/Postal Code:
Country:
HF 54 Serial №:
!

HF54 PLUS Operating Instructions Page 2of 60 January 2019
Table of Contents
1.0 UNPACKING AND INSTALLING YOUR HF 54 ................................................................................ 5
1.1 Check the items shipped .................................................................................................................................. 5
1.2 Cart Assembly Instructions............................................................................................................................... 6
2.0 WARNINGS, INDICATIONS FOR USE, CONTRAINDICATIONS, CAUTIONS AND
PRECAUTIONS.............................................................................................................................. 8
2.1 General Warnings & Cautions .......................................................................................................................... 8
2.2 Interferential Current and Premodulated Current ............................................................................................. 9
2.3 Ultrasound Therapy ........................................................................................................................................ 15
2.4 Horizon Infrared Light Therapy....................................................................................................................... 19
2.5 Combination Treatment .................................................................................................................................. 20
2.6 Markings on the outside of the HF54.............................................................................................................. 21
3.0 INTRODUCTION TO THE HF54 ...................................................................................................... 22
3.1 Standard Accessories..................................................................................................................................... 22
3.2 Optional Accessories...................................................................................................................................... 23
3.3 Technical Description ..................................................................................................................................... 24
3.4 Identification of Wire Connections .................................................................................................................. 26
4.0 HF54 ULTRASOUND SETUP AND OPERATION........................................................................... 28
4.1 Prior to Using the Ultrasound ......................................................................................................................... 28
4.2 Patient Set-Up for Ultrasound......................................................................................................................... 28
4.3 Operating the Ultrasound ............................................................................................................................... 30
5.0 INTERFERENTIAL AND PREMODULATED TREATMENT........................................................... 36
5.1 Prior to Using Interferential and Premodulated Current Therapy ................................................................... 37
5.2 Interferential and Premod Operation .............................................................................................................. 37
5.3 Examples of Electrode Placement.................................................................................................................. 40
6.0 OPERATING ULTRASOUND AND PREMOD IN COMBINATION ................................................. 41
6.1 Principle of Combination Therapy .................................................................................................................. 41
6.2 Patient Set Up for Single Applicator with Premod –Combo 1........................................................................ 41
6.3 Patient Set Up for Both Applicators with Premod –Combo 1 ........................................................................ 43
7.0 OPERATING IN PREMOD, RUSSIAN AND TENS ......................................................................... 45
8.0 INFRARED LIGHT THERAPY ......................................................................................................... 45
8.1 Background .................................................................................................................................................... 45
8.2 Patient Setup .................................................................................................................................................. 45
8.3 Operating the HF023 IR Light Probe .............................................................................................................. 46
9.0 TECHNICAL INFORMATION........................................................................................................... 46
9.1 FDA Compliance............................................................................................................................................. 46
9.2 Technical Specifications HF54 ....................................................................................................................... 47
9.3 Audio Tones ................................................................................................................................................... 52
10.0 EQUIPMENT USE AND CARE ........................................................................................................ 51
10.1 Use and Care of the HF54 Generator ............................................................................................................ 52
10.2 Use and Care of Self-Adhesive Electrodes .................................................................................................... 52
10.3 Use and Care of Carbon Electrodes............................................................................................................... 53
10.4 Use and Care of Lead Wires .......................................................................................................................... 54
10.5 Use and Care of Ultrasound Applicators ........................................................................................................ 54
10.6 Use and Care of your HF023 IR Light Probe.................................................................................................. 54
11.0 EQUIPMENT CHECKS .................................................................................................................. 55
11.1 Checking the HF54 Generator...................................................................................................................... 55
11.2 Checking Ultrasound Applicators ................................................................................................................. 55
11.3 Cut-off switch Checks................................................................................................................................... 55
11.4 Other Accessory Checks .............................................................................................................................. 55

HF54 PLUS Operating Instructions Page 3of 60 January 2019
12.0 CLEANING AND DISINFECTING INSTRUCTIONS...................................................................... 55
12.1 General......................................................................................................................................................... 55
12.2 Surface cleaning and disinfection................................................................................................................. 56
13.0 EQUIPMENT MAINTENANCE....................................................................................................... 57
13.1 Daily Maintenance ........................................................................................................................................ 57
13.2 Weekly Maintenance .................................................................................................................................... 57
13.3 Monthly Maintenance ................................................................................................................................... 57
13.4 Quarterly Maintenance .................................................................................................................................58
13.5 Six-Monthly Maintenance ............................................................................................................................. 58
13.6 Yearly Maintenance...................................................................................................................................... 58
14.0 SERVICE ........................................................................................................................................ 58
14.1 User Replaceable Parts................................................................................................................................ 58
15.0 TROUBLESHOOTING GUIDE....................................................................................................... 58
List of Tables
Table 1—1 : Standard Package Contents ................................................................................................................................. 5
Table 3—1: Standard Accessories ......................................................................................................................................... 22
Table 3—2: Optional Accessories ........................................................................................................................................... 23
Table 3—3: Rear Panel Items ................................................................................................................................................. 26
Table 3—4: List of Controls and Indicators ............................................................................................................................. 27
Table 7—1: IR Light Therapy Applicator Controls ................................................................................................................... 46
Table 8—1: F.D.A. Required Information ................................................................................................................................ 46
Table 8—2: Abbreviations Used on Applicator Labels ............................................................................................................ 47
Table 8—3: Approximate Dimensions and Weight.................................................................................................................. 47
Table 8—4: General and Ultrasound Specifications................................................................................................................ 47
Table 8—5: Interferential/Premodulated Therapy Specifications ............................................................................................ 49
Table 8—6: IR Light Probe Specifications............................................................................................................................... 51
Table 8—8: Electromagnetic Compatibility Standards Complied With.................................................................................... 51
Table 8—9: Electrical Safety Standards Complied With ......................................................................................................... 51
Table 11—1: Cleaning Matrix .................................................................................................................................................. 56
Table 14—1: Troubleshooting matrix ...................................................................................................................................... 58
List of Figures
Figure 1—1: Caster ................................................................................................................................................................... 6
Figure 1—2: Adding Basket....................................................................................................................................................... 6
Figure 3—1: Illustration of standard Accessories .................................................................................................................... 22
Figure 3—2: Horizon Therapy Applicator ................................................................................................................................ 23
Figure 3—3: Carbon Electrodes .............................................................................................................................................. 23
Figure 3—4: Separate Power Supply for Standalone IR Therapy........................................................................................... 27
Figure 3—9: Annotated View of Controls and Ports................................................................................................................ 27
Figure 4—1: Soundhead Cautions .......................................................................................................................................... 29
Figure 4—4: Control Panel ...................................................................................................................................................... 31
Figure 4—5: Time selector button ........................................................................................................................................... 31
Figure 4—7: Ultrasound Applicator Selection.......................................................................................................................... 32
Figure 4—8: Start/Stop Selection ............................................................................................................................................ 32
Figure 4—9: Ultrasound Power Selection ............................................................................................................................... 32
Figure 5—1: Control Panel ...................................................................................................................................................... 38
Figure 5—2: Time selector button ........................................................................................................................................... 38
Figure 5—4: Start/Stop Selection ............................................................................................................................................ 39
Figure 5—5: Electrotherapy Intensity ...................................................................................................................................... 39
Figure 5—6: Electrode placement for upper body................................................................................................................... 40
Figure 5—7: Electrode placement for leg and ankle ............................................................................................................... 40
Figure 6—1: Connecting for Combination premod and ultrasound with one applicator .......................................................... 42
Figure 6—2: Time selector button ........................................................................................................................................... 42
Figure 8—1: Ultrasound Waveform Coupled onto the surface of a water bath (not immersed).............................................. 48
Figure 8—2: Channel 1 output into 500 Ω.............................................................................................................................. 49
Figure 8—3: Channel 2 output into 500 Ω.............................................................................................................................. 49
Figure 8—4: Channel 1 output into 2000 Ω............................................................................................................................ 49
Figure 8—5: Channel 2 output into 2000 Ω............................................................................................................................ 49
Figure 8—6: Channel 1 output into 10000 Ω.......................................................................................................................... 50
Figure 8—7: Channel 2 Output into 10000 Ω.......................................................................................................................... 50

HF54 PLUS Operating Instructions Page 4of 60 January 2019
Figure 8—8: Channel 1 output into 500 Ω.............................................................................................................................. 50
Figure 8—9: Channel 1 output into 2000 Ω............................................................................................................................ 50
Figure 8—10: Channel 1 output into 10000 Ω........................................................................................................................ 51

HF54 PLUS Operating Instructions Page 5of 60 January 2019
PREFACE
This manual is intended as a guide for the operators of the HF54. It contains precautionary
instructions, general instructions for operation and maintenance recommendations. In order to
facilitate the proper operation of HF54 and to obtain maximum efficiency and life from the unit,
READ AND UNDERSTAND THIS MANUAL THOROUGHLY. Be thoroughly acquainted with the
operating procedures, as well as the indications, contraindications, warnings, and precautions
before administering any treatment to a patient. Other resources must be referred for additional
information regarding the application of therapeutic ultrasound.
1.0 Unpacking and Installing Your HF 54
Unpack all items being especially careful with the handling of the swing arm assembly and the
ultrasound generator. These items are sophisticated medical equipment and should be handled
accordingly.
Retain the packaging for your HF 54. You will need it in the event you need to return the
generator for repair.
1.1 Check the items shipped
The HF 54 Standard Package contain the items in Table 1—1. Use the check boxes provided to
record your package items.
Table 1—1 : Standard Package Contents
Description
Part Number
Qty
CHK
HF 54 Generator
HF010
1
72 inch electrode cable
HF001
2
Package 2 inch self adhesive electrode (4 pads)
HF022
1
Package 3 inch self adhesive electrodes (4 pads)
HF002
0
Package 4.75 inch by 2.75 inch self adhesive electrodes
HF003
1
Retainer ring
HF004
1
Stretchable Velcro strap –24” x 4” (Latex Free)
HF005
1
Aquaflex Gel Pad (2cm x 9cm)
HF007
1
Rolling cart tabletop -Gray
HF018
1
Weight bag
HF008
1
960 kHz ultrasound applicator
HF009
1
Ultrasound Applicator Swing Arm
HF011
1
Cut-off switch
HF012
1
8 oz (240ml) Spray bottle for keeping gel moistened
HF013
1
12” long power cable
HF014
1
Instructions for use
HF015
1
Black post for cart
HF016
1
Utility tray
HF017
1
Velcro strap –48” x 2”
HF006
1
Cap screws 1/4-20 x 3/4 long
HF018
4
Cart base (5 star –Black)
HF019
1
Cart base caster –Black
HF020
5
1/2” SAE flat washer
HF021
1
Hill Labs Gel Pad
HF023
1
Black Wire Basket
HF024
1

HF54 PLUS Operating Instructions Page 6of 60 January 2019
1.2 Cart Assembly Instructions
Now that you have checked the contents of the packaging match the list in Section 1.1, you have
all of the parts necessary to assemble the cart.
Step
Instruction
Illustration
1.
Lay the tabletop on floor upside down.
2.
Place cart post on tabletop with metal bar
facing the opposite side of the cord. Line-up
the four holes on the cart post with the four
holes on the tabletop. Place lock washers on
four bolts and screw in bolts using a 7/16 inch
wrench.
Figure 1—1: Caster
3.
Lay tabletop and post on floor with corded
side towards the floor. Hook the upper basket
assembly to the cart post. With one hand
firmly grab the metal bar that is welded to the
post and with the other hand grab the front of
the basket. Forcefully connect the metal bar
with the basket.
Figure 1—2: Adding Basket
4.
Insert the casters into the 5 holes in the arms
of the base. This can be accomplished easily
by hand. Test cart base to determine if
casters are seated properly.
Place the base –casters downward onto a
level surface. If the base is not level, the
casters are not seated properly.
Do not use excessive force (hammer) or you
may crack the caster or the base.
Figure 1—3: 5-arm Cart Base

HF54 PLUS Operating Instructions Page 7of 60 January 2019
5.
Place cart post into cart base.
Push down firmly to ensure that the post is
properly seated.
Figure 1—4: Cart Post Inserted Into Base with Casters Fitted
Step
Instruction
Illustration
6.
Turn the table right side up and place the black
utility tray into the precut hole in the tabletop
(dual soundhead unit will not have black utility
tray).
Figure 1—5: Black Utility Tray
7.
Untape steel washer, which, is taped to
tabletop. Place steel washer over existing
gray plastic shoulder washer with 2 stop pins
located on either side. Do not glue steel
washer to plastic shoulder washer, steel
washer must float freely.
Figure 1—6: Steel washer for Swing-Arm
8.
Place HF54 Unit on the tabletop and plug
power cord in to a wall receptacle.
9.
Insert the swing arm into the steel washer and
gray plastic shoulder washer. If the generator
is facing the assembler, the swing arm should
extend out in the opposite direction as
pictured. Plug soundhead cord into port 1 on
the generator. The HF54 is now ready to
operate.
Figure 1—7: Complete Illustration

HF54 PLUS Operating Instructions Page 8of 60 January 2019
DANGER
TO PREVENT ANY LIKELIHOOD OF FIRE AND ELECTRIC SHOCK. DO NOT ALTER THE
FACTORY VOLTAGE SETTING OF YOUR HF54 EQUIPMENT. IF YOU SUSPECT THAT THE
EQUIPMENT HAS BEEN TAMPERED WITH, CONTACT THE MANUFACTURER
IMMEDIATELY.
FOR NORTH AMERICA, THE VOLTAGE SETTING ON THE REAR OF YOUR HF54 SHOULD
READ 115V. ANY OTHER VALUE IS NOT SUITABLE FOR CONNECTION TO THE US
ELECTIC SUPPLY.
2.0 Warnings, Indications for Use, Contraindications, Cautions and Precautions
Informational symbols used in this manual
Means –Mandatory to read the Instructions. Note the cover page has this symbol
meaning that it is a requirement for safety reasons that the manual is read by the
operator.
Means –“Warning”
Means –“Caution”
Means = “Precaution”
Means –The subject relates to an electrical hazard or an action that could lead to an
electrical hazard
Means –The subject relates to a non-ionizing radiation hazard, e.g. Ultrasound and
High Frequency energy.
Means –The subject matter relates to cleaning of the equipment or hazards
associated with cleaning the equipment.
2.1 General Warnings & Cautions
2.1.1 Mandatory Instruction
Read these instructions before use or attempting any assembly
Thoroughly read this manual before setting up treatment for the first time. Frequently
return to this manual to reacquaint yourself with the correct use of your HF54.
Before treating with the HF54 Ultrasound with Interferential and IR Light Therapy,
see Section 2.0 covering the “Contraindications, Warnings, and Precautions”

HF54 PLUS Operating Instructions Page 9of 60 January 2019
Retain the packaging for your HF54. You will need it in the event you need to return
the generator for repair.
2.1.2 General Warnings
WARNING
To avoid the risk of fire or electric shock, replace fuses only with the same type and
rating.
WARNING
To avoid the risk of fire or damage to the device, do not get liquids inside the
equipment or its accessories.
WARNING
This Instrument contains dangerous voltages. Refer service to qualified personnel
only.
WARNING
Do not use the same power outlet or line with a whirlpool, certain traction machines or
other heavy equipment
WARNING
The HF54 should be used only under the continued supervision of a physician.
2.1.3 General Cautions
“CAUTION: Federal law restricts this device to sale by or on the order of a
practitioner licensed by the law of the State in which he/she practices to
use or order the use of the device.”
CAUTION
Use of operation control or adjustments or performance of procedures other than
those specified herein may result in hazardous exposure to ultrasonic energy.
CAUTION
Before cleaning or disinfecting your HF54 or its accessories, always turn off power to
the equipment and disconnect the plug from the outlet (prevents accidentally turning
the equipment on). Always clean and disinfect in a well ventilated area.
CAUTION
Use a commercially available surge suppressor if power problems are encountered.
CAUTION
In areas which are carpeted and static electricity is present, it may be necessary to
use a conductive mat to remove any static charge from the operator (note that there is
no danger to the equipment but static build up can be in excess of 50 kilovolts and will
discharge to electrodes attached to patients causing discomfort)
CAUTION
Only use the cleaning materials identified in section 12.0. These materials have been
tested with the equipment and found to be compatible for repeated application
2.2 Interferential Current and Premodulated Current

HF54 PLUS Operating Instructions Page 10 of 60 January 2019
2.2.1 Interferential Current and Premodulated Current Indications for use
These are the conditions for which Interferential Current (IFC) or Premodulated Current can be
used.
Symptomatic relief of chronic intractable pain and/or management of post-traumatic or post
surgical pain.
2.2.2 Interferential Current and Premodulated Current Contraindications for Use
2.2.2.1 Contraindicated Conditions
These are the conditions under which an electrical stimulator should not be used;
•Patients who do not comprehend the physiotherapist’s instructions or are unable to co-
operate should not be treated
•Powered muscle stimulators should not be used on patients with cardiac demand
pacemakers;
•Do not use on patients prone to epileptic seizures
•Do not use on patients that are prone to hemorrhage
•Do not use this device whenever pain syndromes are undiagnosed, until etiology is
established;
•Do not use with patients diagnosed with disease processes causing increased local or
general metabolism (inferential current)
2.2.2.2 Contraindicated Areas
•Desensitized areas (low volt galvanic stimulation);
•Over the carotid sinus nerves, neck or mouth;
•Stimulation should not be applied transthoracically in that the introduction of electrical current
into the heart may cause cardiac arrhythmias;
•Do not apply electrodes such that current flows transcerebrally (through the head);
•Directly over or through a metal implant (low volt galvanic);
•Over moles or warts;
•Directly over abrasions, open wounds or sites of infection;
•Directly over, near or through a recent unhealed fracture site (stimulation of overlying muscle
to contraction);
•Directly over or through the heart;
•Directly over or near a pregnant uterus;
•On or near thrombosis;
•Over or in proximity to cancerous lesions;
•Avoid active epiphyseal regions in children.
2.2.3 Interferential Current and Premodulated Current Warnings
1
WARNING
The long term effects of chronic electronic stimulation are unknown

HF54 PLUS Operating Instructions Page 11 of 60 January 2019
2
WARNING
Do not stimulate over the carotid sinus nerves, especially in patients with a known
sensitivity to the carotid sinus reflex
3
WARNING
Stimulation should not be applied over the neck or mouth. Severe spasm of the
laryngeal and pharyngeal muscles may occur and the contractions may be strong
enough to close the airway or cause difficulty in breathing
4
WARNING
Stimulation should not be applied transthoracically in that the introduction of electrical
current into the heart may cause cardiac arrhythmias
5
WARNING
Stimulation must not be applied transcerebrally
6
WARNING
Stimulation should not be applied over swollen, infected, or inflamed areas or skin
eruptions, e.g., phlebitis, thrombophlebitis, varicose veins, etc
7
WARNING
Stimulation should not be applied over, or in proximity to, cancerous lesions
8
WARNING
Electronic monitoring equipment (such as ECG monitors and ECG alarms) may not
operate properly when stimulation is in use on the same patient
9
WARNING
This device is not effective for pain of central origin (including headache).
10
WARNING
Stimulation delivered by the device may be sufficient to cause electrocution in some
patients with a low tolerance to electrical current
11
WARNING
Electronic stimulation should be kept to below 2 mA/cm2. Burns to tissue may occur
quickly if this current density is exceeded.
12
WARNING
Do not operate generator during lightning, thunderstorms or a condition that could
have an adverse effect on continuity of power flow to generator
13
WARNING
Never remove or attach electrodes during treatment. Always stop the treatment
before applying or removing electrodes
14
WARNING
Never used worn or damaged leads or electrodes

HF54 PLUS Operating Instructions Page 12 of 60 January 2019
15
WARNING
Do not turn off generator by main power switch while treatment is being given to
patient
16
WARNING
Simultaneous connection of a patient to an h.f. surgical equipment may result in
burns at the site the stimulator electrodes and possible damage to the stimulator
17
WARNING
Operation in close proximity (e.g. 1 m) to shortwave or microwave therapy equipment
may produce instability in the stimulator output
18
WARNING
This device should be used only under the continued supervision of a physician
2.2.4 Interferential Current and Premodulated Current Cautions and Precautions
2.2.4.1 Cautions
1
CAUTION
Safety of powered muscle stimulators for use during pregnancy has not been
established
2
Caution should be used for patients with suspected or diagnosed heart problems
3
Caution should be used for patients with suspected or diagnosed epilepsy
4
Caution should be used in the presence of the following:
a. When there is a tendency to hemorrhage following acute trauma or fracture;
b. Following recent surgical procedures when muscle contraction may disrupt the
healing process;
c. Over the menstruating or pregnant uterus; and
d. Over areas of the skin which lack normal sensation
5
CAUTION
Some patients may experience skin irritation or hypersensitivity due to the electrical
stimulation or electrical conductive medium. The irritation can usually be reduced by
using an alternate conductive medium or alternate electrode placement.
6
CAUTION
Electrode placement and stimulation settings should be based on the guidance of the
prescribing practitioner
7
CAUTION
The HF54 should be kept out of the reach of children

HF54 PLUS Operating Instructions Page 13 of 60 January 2019
8
CAUTION
The HF54 should be used only with the leads and electrodes recommended for use by
Hill Laboratories
9
CAUTION
The device has no curative value. Current is symptomatic treatment that suppresses
the sensation of pain, which would otherwise serve as a protective mechanism
2.2.5 Interferential Current and Premodulated Current Precautions
1
Ensure that the electrodes are not touching each other or within 1 inch (2.5 cm) of each
other. Failure to maintain adequate distances may lead to error code 1 being displayed
and the need to reset the HF54 and reposition the electrodes;
2
Do not connect stimulator cables to Garments without the electrodes being secured in
place;
3
Each electrode must completely cover its metal connection;
4
Disposable electrodes are for single patient use only;
5
Reusable electrodes must be disinfected in accordance with the instructions in this
manual prior to use on a patient;
6
Do not apply to broken skin; if a rash appears, discontinue use and consult your
medical professional;
7
If there is abnormal skin sensation, electrodes should be positioned in a site other than
this area to ensure effective stimulation;
8
Be careful when treating patients who have (marked) abnormal circulation;
9
For patients who have febrile conditions, the outcome of the first treatment should be
monitored;
10
Patients who have epilepsy, advanced cardiovascular conditions or cardiac arrhythmias
should be treated at the discretion of the physiotherapist in consultation with the
appropriate medical practitioner;
11
Caution must be used with treatment which involves placement of electrodes over the
anterior chest wall;
12
Isolated cases of skin irritation may occur at the site of electrode placement following
long-term application;
13
Effectiveness is highly dependent upon patient selection by a person qualified in the
management of pain.

HF54 PLUS Operating Instructions Page 14 of 60 January 2019
2.2.5.1 Adverse Effects:
•Skin irritation and burns beneath the electrodes have been reported with the use of
interferential and premodulated currents. This can be caused by excessive current for the
size of electrode being used.
2.2.6 Interferential Current and Premodulated Current Usage Precaution Notes
A patient’s tendency to have adverse reactions to electrotherapy is dependent upon several
factors. Some of these factors are discussed below. In addition to cautions listed below, read the
section in this manual entitled “Contraindications, Warnings, and Precautions.”
Electrical stimulation, by its very nature, has the ability to irritate the patient’s skin. Certain
precautions should be observed to assure maximum safety and comfort for patients. A patient’s
tendency to have adverse reactions is dependent upon several factors. These factors are:
Current Density –This is the amount of current being delivered to the patient divided by the area
through which the current is being delivered (the surface area of the electrodes being used).
Example -In a circuit with the smallest electrode equal to 5 cm x 7 cm or 4 inches round, with an
applied current of 50 mA, the current density is
WidthLengthElectrode
CurrentApplied
×
=
cm
mA
75
50
×
= 1.43
mA/cm2.
Electrode Condition –Worn or dried out electrodes cause the current to concentrate in small
areas of the electrode instead of going into the skin distributed evenly throughout the entire
electrode surface. This has the effect of increasing the current density, since the current is being
delivered through a smaller area.
Patient Susceptibility –Some patients’ skin is more sensitive to electrotherapy currents. This can
cause a reaction similar to heat rash.
Electrotherapy treatment can result in a rash, burn, or blister. The tendency to do this is
dependent upon the factors listed above and can be minimized by applying the following
guidelines:
1. Use only moderate current. It is not always necessary to raise the treatment intensity to just
short of the patient’s pain threshold to achieve adequate results. For carbon or self adhesive
pads slowly increase intensity to patient comfort. Use as large an electrode as is practical for
the application. Note that the current density in a 1.25” square electrode is Five Times the
current density in a 1.75” x 3.75” electrode for the same intensity setting. Using larger
electrodes allows current to be delivered over a larger area of the body, keeping the current
density to be as low as possible and minimizing the possibility for adverse reactions. Do not
exceed patient tolerance in setting the intensity. Consult published medical literature for
more
The maximum recommended intensity for electrotherapy (interferential and Premod) is 15-20.
2. Ensure that the area on the patient’s skin where the electrode is to be placed is clean and
free of foreign matter. This includes powders, perfumes, and the like, as well as body oils or
dirt and grime. Cleaning with an alcohol wipe should be adequate. Allow the alcohol to fully
evaporate before applying the electrodes.
3. Make sure the electrodes being used are in good condition. The self-adhesive electrodes
should have good adhesion over the entire surface area of the electrode. The area where
the leads attach to the electrode (either through a lead or a snap) should not be damaged
such that the connection to the foil backing behind the adhesive is broken. Carbon
electrodes should be deep black, and should be free of cracks in the electrode surface.
*Any electrode which is suspect should be discarded.
4. Some patients tend to be much more sensitive to electrotherapy treatments. On patients with
this tendency, treat with reduced intensity and/or shorter treatment times, with possibly more
frequent treatments, if required. Most reactions are localized and very short-lived, so limiting
the exposure should minimize any potential for adverse reactions.

HF54 PLUS Operating Instructions Page 15 of 60 January 2019
2.3 Ultrasound Therapy
Ultrasound is used to treat a variety of inflammatory and traumatic conditions. Ultrasonic energy
is mechanical vibration identical to that of sound but of a high frequency. It is caused when an
electrical signal is applied to the piezoelectric transducer material that converts the electrical
energy into mechanical (sound) energy.
2.3.1 Ultrasound Therapy Indications for Use
Ultrasound is indicated for applying therapeutic deep heat within body tissues for the treatment of
selected medical conditions such as:
•Relief of pain
•Muscle spasms
•Joint contractures
The use of ultrasonic energy in therapy should not be considered as specific treatment
for any disease.
2.3.2 Ultrasound Therapy Contraindications
It is contraindicated to apply therapeutic ultrasound to patients with any of the following
conditions:
2.3.2.1 Contraindicated conditions
•Pregnancy
•Acute and sub-acute thrombosis and thrombophlebitis
•Potentially Malignant lesions, tumors malignant or benign
•Areas or lumps that may be suspected as cancerous or precancerous
•Third degree musculo-tendonous lesions
•Cardiac pacemaker
•Implants of any electrical nature
•Skin diseases
•Multiple sclerosis
•Osteomyelitis
•Disturbances in cardiac rhythm
•Tissue or bone with acute sepsis
•Arteriosclerosis or weakened blood vessels
•Hemophilia
•Where sensory nerve damage is present with a loss of normal skin sensation

HF54 PLUS Operating Instructions Page 16 of 60 January 2019
2.3.2.2 Contraindicated Areas
It is contraindicated to apply ultrasound to any of the following areas:
•Transcerebrally
•To the eye
•To the ear
•Over a carotid sinus
•To the heart
•To major subcutaneous nerves and blood vessels
•To the spinal cord
•Around the bulbar area of the spinal cord
•To reproductive organs
•Over viscera (stomach, spleen, liver)
•Over or near epiphyseal areas of the bones in growing children, or adults until bone growth is
complete
•Over stellate ganglion and subcutaneous major nerves
•To tissues previously treated by deep X-ray or other radiation
•Over the joint capsule in acute or sub-acute arthritic conditions
•Over ischemic tissue in patients with vascular disease
•Over a laminectomy site
•Over total joint replacements (the effect of ultrasound on new plastics is unknown)
•Over any internal metal
•Over a healing fracture
2.3.3 Ultrasound Warnings
1
WARNING
Do not use the Ultrasound for underwater treatments. The applicators are not
watertight
2
Never operate the instrument at a level where the patient feels pain, and if you have
any doubts about the proper level of dosage, select a lower amount
3
WARNING
When using, the applicator must be moved in a circular motion around the treatment
site.
4
WARNING
Do not use in general area where high-powered, high frequency transmitting
generators are being operated. Short wave diathermy should not be used within 8
feet (2.5 m) of the HF54.
5
WARNING
Avoid unnecessary exposure to ultrasound (patient and therapist)
6
WARNING
Do not turn off generator by main power switch while treatment is being given to
patient

HF54 PLUS Operating Instructions Page 17 of 60 January 2019
7
WARNING
Do not operate generator during lightning, thunderstorms or a condition that could
have adverse effects on continuity of power flow to generator
2.3.4 Ultrasound Usage Cautions
1
CAUTION
It is recommended that the Gel Pad part number HF007 is used with the HF54.
2
CAUTION
Ultrasound by its very nature has the ability to irritate the patient’s skin. Ultrasound’s
advantages far outweigh any disadvantages, but certain precautions should be taken to
minimize the likelihood of irritation.
3
CAUTION
A patient’s tendency to have adverse reactions to ultrasound is dependent upon
several factors. Some of these factors are discussed below. In addition to cautions
listed below, read the section in this manual entitled “Contraindications, Warnings, and
Precautions
4
CAUTION
The ultrasound applicator is not suitable for immersion in water. Immersion will cause
damage to the applicator.
2.3.5 Ultrasound Precautions
2
Some patients’ skin is more sensitive to ultrasound output. This can cause a reaction
similar to a heat rash
3
Higher output levels have a greater potential for patient discomfort. Output power may
be reduced by simply choosing a lower W/cm2setting
4
Do not use ultrasound:
a. Over an area of the spinal cord following a laminectomy, i.e., when major covering
tissues have been removed
b. Over anesthetic area
c. On patients with hemorrhagic diathesis
2.3.6 Ultrasound Usage Precaution Notes
2.3.6.1 Potential for Burns
It is possible for a patient to suffer a burn from ultrasound therapy if the therapy is not
administered properly. Burns can occur for the following reasons:
•Too high intensity (power).
•Treating an area where sensory nerve damage is present with a loss of normal skin
sensation.
•Over bony prominences because they reflect sound waves and increase intensity to the
periosteum.
•Desensitized areas can be overheated or burned without the patient realizing it, so extreme
care must be taken with these patients, e.g. on areas that are anesthetized.

HF54 PLUS Operating Instructions Page 18 of 60 January 2019
Burns can be avoided as long as the treatment causes no pain, tingling, excess heat or aching
(for patients with normal skin sensation). The gel pad is recommended to ensure sufficient
coupling agent. If liquid gel is used, make sure to place an ample amount between the applicator
and the patient. Failure to do so may cause skin irritations or surface burns.
2.3.7 Dosage
The dosage received by the patient is primarily a function of the wattage and, to a lesser extent,
the length of time. The prescription for ultrasound treatment will usually designate the wattage
level at which treatments are to be carried out. At no time must a patient encounter discomfort
during ultrasound treatment. A feeling of slight warmth or often a slight tingling sensation is all
that should be experienced by the patient.
Figure 2—1: Estimated steady-state thermal temperatures in soft tissues rise for different
output power settings
The graph above identifies the level of temperature rise between 40 to 45 °C as the
temperature level deemed therapeutic by the FDA. Treatments should be done in this
therapeutic temperature range to be effective.

HF54 PLUS Operating Instructions Page 19 of 60 January 2019
Figure 2—2: Thermal Steady State Estimates for Bone Heating (when using Optional Hands-Free
Operation).
2.4 Horizon Infrared Light Therapy
2.4.1 Indications
Application of infrared energy to apply topical heating for the treatment of selected medical
conditions such as:
•Temporary increase in local blood circulation
•Temporary relief of minor muscle and joint aches, pains and stiffness
•Relaxation of muscles
•Muscle spasms
•Minor pain and stiffness associated with arthritis
2.4.2 Contraindications
1. Cancer (tumors or cancerous areas)
2. Direct irradiation of eyes
3. Treatment of patients with idiopathic photophobia or abnormally high sensitivity to light.
Some medications are known to increase sensitivity to light
4. Patients that have been pre-treated with one or more photosensitizers
5. Direct irradiation over the fetus or the uterus during pregnancy
6. Direct irradiation of the thyroid gland and endocrine glands
7. Patients with pacemakers
8. Growing children (Epiphyseal plates)
2.4.3 Infra Red Therapy Warnings
1
WARNING
The Infra Red Therapy Applicator should not make direct contact with open wounds.