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HF54 Plus • Instructions for Use
Including Instructions for Use for Horizon (HF023) IR Light Probe
R
x
ONLY
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.
PRESCRIPTION USE STATEMENT
Document No: 16-00104
Version: 06
Revised: January 2019
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Related Manuals for Hill Laboratories HF54 Plus
Summary of Contents for Hill Laboratories HF54 Plus
- Page 1 HF54 Plus • Instructions for Use Including Instructions for Use for Horizon (HF023) IR Light Probe Document No: 16-00104 ONLY 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...
- Page 2 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.
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Page 3: Table Of Contents
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 of 60 January 2019... - Page 4 Ω Figure 8—5: Channel 2 output into 2000 ..........................49 Ω Figure 8—6: Channel 1 output into 10000 .......................... 50 Ω Figure 8—7: Channel 2 Output into 10000 .......................... 50 Ω HF54 PLUS Operating Instructions Page of 60 January 2019...
- Page 5 Figure 8—8: Channel 1 output into 500 ..........................50 Ω Figure 8—9: Channel 1 output into 2000 ..........................50 Ω Figure 8—10: Channel 1 output into 10000 ........................51 Ω HF54 PLUS Operating Instructions Page of 60 January 2019...
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Page 6: Unpacking And Installing Your Hf 54
Cap screws 1/4-20 x 3/4 long HF018 Cart base (5 star – Black) HF019 Cart base caster – Black HF020 1/2” SAE flat washer HF021 Hill Labs Gel Pad HF023 Black Wire Basket HF024 HF54 PLUS Operating Instructions Page of 60 January 2019... -
Page 7: Cart Assembly Instructions
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 of 60 January 2019... - Page 8 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 of 60 January 2019...
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Page 9: Warnings, Indications For Use, Contraindications, Cautions And Precautions
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 of 60... -
Page 10: Interferential Current And Premodulated Current
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 Interferential Current and Premodulated Current HF54 PLUS Operating Instructions Page of 60 January 2019... - Page 11 Over or in proximity to cancerous lesions; • Avoid active epiphyseal regions in children. • 2.2.3 Interferential Current and Premodulated Current Warnings WARNING The long term effects of chronic electronic stimulation are unknown HF54 PLUS Operating Instructions Page of 60 January 2019...
- Page 12 WARNING Never remove or attach electrodes during treatment. Always stop the treatment before applying or removing electrodes WARNING Never used worn or damaged leads or electrodes HF54 PLUS Operating Instructions Page of 60 January 2019...
- Page 13 CAUTION Electrode placement and stimulation settings should be based on the guidance of the prescribing practitioner CAUTION The HF54 should be kept out of the reach of children HF54 PLUS Operating Instructions Page of 60 January 2019...
- Page 14 Isolated cases of skin irritation may occur at the site of electrode placement following long-term application; Effectiveness is highly dependent upon patient selection by a person qualified in the management of pain. HF54 PLUS Operating Instructions Page of 60 January 2019...
- Page 15 Most reactions are localized and very short-lived, so limiting the exposure should minimize any potential for adverse reactions. HF54 PLUS Operating Instructions Page of 60...
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Page 16: Ultrasound Therapy
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 of 60 January 2019... - Page 17 (2.5 m) of the HF54. WARNING Avoid unnecessary exposure to ultrasound (patient and therapist) WARNING Do not turn off generator by main power switch while treatment is being given to patient HF54 PLUS Operating Instructions Page of 60 January 2019...
- Page 18 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 of 60 January 2019...
- Page 19 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 of 60...
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Page 20: Horizon Infrared Light Therapy
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 WARNING The Infra Red Therapy Applicator should not make direct contact with open wounds. HF54 PLUS Operating Instructions Page of 60 January 2019... -
Page 21: Combination Treatment
When delivering combination ultrasound and Premod through the applicator, do not exceed patient tolerance in setting the intensity. The maximum recommended intensity for electrotherapy is 15-20 mA used with a 65 cm applicator HF54 PLUS Operating Instructions Page of 60 January 2019... -
Page 22: Markings On The Outside Of The Hf54
Markings on the outside of the HF54 Hill Laboratories, Bacton Hill Rd. Frazer, PA Hill Laboratories, Bacton Hill Rd. Frazer, PA 19355 19355 Serial # 00000 Serial # 00000 Date: month/year Date: month/year Label on the IR Light Therapy Applicator... -
Page 23: Introduction To The Hf54
Cap screws 1/4-20 x 3/4 long HF018 Cart base (5 star – Black) HF019 Cart base caster – Black HF020 1/2” SAE flat washer HF021 Figure 3—1: Illustration of standard Accessories HF54 PLUS Operating Instructions Page of 60 January 2019... -
Page 24: Optional Accessories
Infrared Light Therapy Applicator HF025 Hand-Held Ultrasound Applicator HF024 Carbon Electrodes HF030 Separate Power Supply for Standalone IR Therapy Figure 3—2: Handheld Ultrasound Applicator Figure 3—3: Infrared Light Therapy Applicator Figure 3—4: Carbon Electrodes HF54 PLUS Operating Instructions Page of 60 January 2019... -
Page 25: Technical Description
HF54 PLUS Operating Instructions Page of 60... - Page 26 It uses the gate control theory that states that if a pain message has already stimulated the nerve fibers of the spinal cord, the gate closes which inhibits the occurrence of another pain message. HF54 PLUS Operating Instructions Page of 60...
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Page 27: Identification Of Wire Connections
5 minutes after the ultrasound treatment. Identification of Wire Connections 3.4.1 HF54 Plus Rear Panel Outputs Table 3—3: Rear Panel Items Patient Switch USB Port Standard 5 cm. -
Page 28: Table 3-4: List Of Controls And Indicators
Up and Down arrows for ultrasound LED indicators and display for ultrasound Start/Stop button for ultrasound Pause/Resume button for ultrasound Combo button for combination therapy Band button for Hand-held ultrasound Mode button for Hand-held ultrasound HF54 PLUS Operating Instructions Page of 60 January 2019... -
Page 29: Hf54 Ultrasound Setup And Operation
Gel Pad P/N HF007 must be used with the HF54 when using the Ultrasound or Combination modes. Failure to do so may cause skin irritations or surface burns. 2. Use alcohol or an alcohol wipe to prepare the treatment site. HF54 PLUS Operating Instructions Page of 60 January 2019... -
Page 30: Figure 4-1: Soundhead Cautions
Figure 4—1: Soundhead Cautions 4.2.1 Ultrasound Output Conversion (Based on ERA) The HF54 Console displays in W/cm HF54 PLUS Operating Instructions Page of 60 January 2019... -
Page 31: Operating The Ultrasound
Turn on the main power switch located on the left side of the generator. NOTE: The generator should be turned off at the end of business hours or when not in use for several hours. HF54 PLUS Operating Instructions Page of 60... -
Page 32: Figure 4-4: Control Panel
During treatment, you can adjust the time at any point by using the selector arrows (see Figure 4- 6). Time can also be adjusted by pressing the Pause/Resume button then using the selector arrows to adjust. HF54 PLUS Operating Instructions Page of 60... -
Page 33: Figure 4-7: Ultrasound Applicator Selection
See below for recommended settings. The factory default display of ultrasound power is expressed in Watts/cm Figure 4—6: Ultrasound Power Selection The ultrasound power can also be expressed in Temporal Average Watts/cm HF54 PLUS Operating Instructions Page of 60 January 2019... - Page 34 Do not place the weight bag on the coaxial connection (see Figure 4—11). The connection may fail or break if the weight bag is placed on the coaxial connection. Figure 4—11: Keep off area for weight bag HF54 PLUS Operating Instructions Page of 60 January 2019...
- Page 35 Figure 4—13: Thermal Steady State Estimates for Bone Heating for Hands-Free Operation 4.4.2 Regions of the Body Suitable for Hands-Free Operation NOTE: Constant attendance is advisable as defined as “verbal, visual or manual” (per ACA, AMA) HF54 PLUS Operating Instructions Page of 60 January 2019...
- Page 36 Figure 4—14: Treatment zones when using Optional Hands-free operation. Figure 4—15: Ultrasound Application examples HF54 PLUS Operating Instructions Page of 60 January 2019...
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Page 37: Interferential And Premodulated Treatment
The two frequencies are mixed inside the HF54 and the output waveform is present on two of the electrode leads rather than the four in interferential mode. Premodulated therapy is used when the application area is smaller and interferential cannot be used. HF54 PLUS Operating Instructions Page of 60 January 2019... -
Page 38: Prior To Using Interferential And Premodulated Current Therapy
The metal foil can cause changes in the waveform and the resistance of the rubber electrodes is extremely variable. If the self-adhesive pads lose their adhesive and conductive properties discard the pads and replace them with new electrodes from Hill Laboratories (available at shop.hilllabs.com) -
Page 39: Figure 5-1: Control Panel
During treatment, you can adjust the time at any point by using the selector arrows (see section 5.2.3. Time can also be adjusted by pressing the Pause/Resume button then using the selector arrows to adjust. HF54 PLUS Operating Instructions Page of 60... -
Page 40: Figure 5-4: Start/Stop Selection
The timer will automatically turn the instrument off at the end of the treatment time. 5.2.9 Changing Time, Intensity or Frequencies During Treatment Intensity can be increased or decreased only during a treatment. Time can be adjusted during treatment or when a treatment is paused. HF54 PLUS Operating Instructions Page of 60 January 2019... -
Page 41: Examples Of Electrode Placement
Shoulder Muscles Stimulation Figure 5—5: Electrode placement for upper body Quadriceps Muscles Hamstrings Muscles Knee Ankle Stimulation Stimulations Stimulation Stimulation Figure 5—6: Electrode placement for leg and ankle By permission from LSI International HF54 PLUS Operating Instructions Page of 60 January 2019... -
Page 42: Operating Ultrasound And Premod In Combination
1. Applicator 1 or 2 will be producing Premod and ultrasound. 2. The red lead wire from the first channel is the active (hot) ground pad. 3. 4” or larger pad is required for the red lead wire. HF54 PLUS Operating Instructions Page of 60... -
Page 43: Figure 6-1: Connecting For Combination Premod And Ultrasound With One Applicator
Set the duration of the treatment by pressing the “Select” button to select the Time LED, then press the arrow buttons to select the desired treatment duration. Figure 6—2: Setting Time of Combo Treatment HF54 PLUS Operating Instructions Page of 60... -
Page 44: Patient Set Up For Both Applicators With Premod - Combo 1
I and 2 and the muscle stim will have the same intensities. CAUTION When using both ultrasound applicators in combination 1, the red lead wire from channel one need to use the splitter lead with 2 electrodes 2.75x4.75" electrodes. HF54 PLUS Operating Instructions Page of 60 January 2019... - Page 45 Alcohol, soap & water are the recommended cleaning substances. Abrasive cleaners should not be used on the applicators or generator. You may damage the ultrasound applicators and damage the finish on the generator. HF54 PLUS Operating Instructions Page of 60...
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Page 46: Operating In Premod, Russian And Tens
The HF023 IR Light Therapy applicator plugs directly into the HF54 Plus Unit Hill Laboratories HF023 IR Light Therapy is generated by an infrared and red light therapy applicator. It contains 36 Infrared LED’s and 7 Visible Red LED’s. The diameter of the LED cluster is approximately 2 inches. -
Page 47: Operating The Hf023 Ir Light Probe
Percent Error of Effective Radiating Area ............< ± Percent Error of Ratio of Temporal-Maximum to Temporal-Average Effective ± Intensity....................... Percent Error of Pulse Duration ................< Percent Error in Indication of Radiated Power ........... < + HF54 PLUS Operating Instructions Page of 60 January 2019... -
Page 48: Technical Specifications Hf54
Ultrasound Wave Form: ....Amplitude modulated, sinusoidal Peak Pulse Intensity: ....5.4 times average BNR:..........≤ 6 (typical between 4.8 and 5) ERA:..........32 cm ± 3 cm (Limits 30 cm to 34 cm HF54 PLUS Operating Instructions Page of 60 January 2019... -
Page 49: Figure 8-1: Ultrasound Waveform Coupled Onto The Surface Of A Water Bath (Not Immersed)
Ω Figure 9—1: Ultrasound Waveform Coupled onto the surface of a water bath (not immersed) HF54 PLUS Operating Instructions Page of 60 January 2019... -
Page 50: Table 8-5: Interferential/Premodulated Therapy Specifications
Figure 9—2: Channel 1 output into 500 Ω Figure 9—3: Channel 2 output into 500 Ω Figure 9—4: Channel 1 output into 2000 Ω Figure 9—5: Channel 2 output into 2000 Ω HF54 PLUS Operating Instructions Page of 60 January 2019... -
Page 51: Figure 8-6: Channel 1 Output Into 10000 Ω
Figure 9—6: Channel 1 output into 10000 Ω Figure 9—7: Channel 2 Output into 10000 Ω 9.2.4.2 Premodulated Current Waveforms Figure 9—8: Channel 1 output into 500 Ω Figure 9—9: Channel 1 output into 2000 Ω HF54 PLUS Operating Instructions Page of 60 January 2019... -
Page 52: Table 8-6: Ir Light Probe Specifications
Safety Medical Electrical Equipment- Part 1: General Requirements CAN/CSA 22.2 No. 601.1(M90): . for Safety EN 60601-1: 1990 +A1, +A2, Medical Electrical Equipment- Part 1: General Requirements +A13:........... for Safety HF54 PLUS Operating Instructions Page of 60 January 2019... -
Page 53: Audio Tones
HF54 and its accessories. 10.2 Use and Care of Self-Adhesive Electrodes Hill Laboratories recommends using a 2” self-adhesive electrode with the HF54 for premod and interferential. A 2.75x4.75” self- adhesive electrode is recommended when Premod is used in combination with ultrasound. -
Page 54: Use And Care Of Carbon Electrodes
2. Carbon electrodes must be free from any build-up. If electrodes have a buildup from body oils or a moistening agent such as an electrolyte spray, conductivity is greatly impaired. If treatment is allowed to continue, intensity could be inhibited. HF54 PLUS Operating Instructions Page of 60... -
Page 55: Use And Care Of Lead Wires
Improper use of the coupling medium or allowing air between the applicator and the surface being treated can affect the calibration. Only HF54 applicators provided by Hill Laboratories can be used with the HF54 generator. Two Applicators can be used simultaneously with the HF54. They can be used interchangeably and are self-calibrating to match the unit. -
Page 56: Equipment Checks
Hypochlorite Solution is used to clean the surface of the generator, the bleach within it will probably kill most of the bacteria but does not mean that if the surface is covered with dust and grime it will clean it. HF54 PLUS Operating Instructions Page of 60... -
Page 57: Surface Cleaning And Disinfection
5 Do not get the polish onto the treatment surface of the ultrasound applicator. 6 Do not get the polish onto the glass surface of the IR Therapy applicator. HF54 PLUS Operating Instructions Page of 60... -
Page 58: Equipment Maintenance
7 Do not apply as a spray near or over ventilation openings. Use a lint-free cloth and spray the cleaning fluid onto the cloth. Do not apply such that the cloth is soaked otherwise fluid will enter through ventilation openings or joins in the enclosure. HF54 PLUS Operating Instructions Page of 60... -
Page 59: Quarterly Maintenance
EEPROM m emory If t he p roblem i s h appening f requently, c all f or a ssistance; • HF54 PLUS Operating Instructions Page of 60 January 2019... - Page 60 If t he p roblem i s n ot s olved a fter t he a pplicator i s c hanged, c all f or • assistance; HF54 PLUS Operating Instructions Page of 60...
- Page 61 Direct all inquiries for parts and service to: Hill Laboratories Co., 3 N. Bacton Hill Rd., P O Box 2028 Frazer, PA 19355 Tel: (610) 644-2867 FAX 610-647-6297 E-mail info@HillTherapy.com HF54 PLUS Operating Instructions Page of 60 January 2019...
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