User Manual
32 Pages
Preview
Page 1
AMPCARE ES™ Powered Muscle Stimulator User Manual
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TABLE OF CONTENTS 1. Foreword
2
2. Product Description
2
3. General Safety
3-4
4. Indications for Use, Intended Uses
5
5. Contraindications
5
6. Warnings
6
7. Precautions
6-7
8. Adverse Reactions
7
9. Nomenclature
8-10
10. Specifications
11-14
11. Markings and Labels
15
12. Set Up
16-17
13. Operating Directions for Use
18-19
14. Programming Directions for Use
20-23
15. Accessories
24
16. Training Program
25
17. Maintenance
25
18. Warranty
25-26
19. Ordering supplies
27
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User Manual for the AMPCARE ES™ Thank you for purchasing the AMPCARE ES™.
1.
Foreword
Read this User Manual carefully before you start using your AMPCARE ES™. This manual has been written for the users of the AMPCARE ES™. It contains general safety information on the operation, precautionary practices and care information. In order to maximize use, efficiency and the life of the system, please read this manual thoroughly and become familiar with the controls, as well as the accessories before operating this system. Before administering any treatment to a patient, the users of this equipment should read, understand and follow the information contained in this manual for the mode of treatment available, as well as the indications, contraindications, warnings, precautions and adverse reactions.
2.
Product Description
The AMPCARE ES™ is a portable two-channel electrotherapy unit used in treating single or multiple patients with oral-pharyngeal dysfunctions (dysphagia) and disorders of the head and neck. Stay current with the latest clinical developments in the field of AMPCARE ESP™ (Effective Swallowing Protocol) Therapy System and observe all applicable precautionary measures for treatment. Federal Law restricts this device to sale by or on the order of a physician or licensed practitioner. This equipment is to be used only by a licensed practitioner certified in the use of AMPCARE ESP™ Therapy System. 2
3.
General Safety
Read, understand, and practice the precautionary and operating instructions. Know the limitations and hazards associated with using any electrical stimulation device. Observe the precautionary and operational decals placed on the unit.
DO NOT operate this unit in an environment where other devices are being used that intentionally radiate electromagnetic energy in an unshielded manner. Portable and mobile RF communications equipment can affect Medical Electrical Equipment.
DO NOT use sharp objects such as a pencil point or ballpoint pen to operate the buttons on the control panel.
This unit should be operated, transported and stored in temperatures between 40ºF and 104ºF and Relative Humidity between 10% and 80%.
Make sure the unit output is turned off before connecting the lead wires to the unit prior to therapy or before removing electrodes from the skin after therapy.
Place the patient in a comfortable position during AMPCARE ES™ therapy session.
Do not submerge or otherwise immerse in liquids as the AMPCARE ES™ is not designed to prevent the ingress of water or liquids. Ingress of water or liquids could cause malfunction of internal components of the system and therefore create a risk of injury to the patient.
Inspect lead wires and associated connectors for signs of damage before each use. Replace damaged lead wires immediately with new before any treatment is applied.
Always check the stimulation controls before treating a patient. The stimulation amplitude/intensity should always be adjusted gradually.
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3.
General Safety (continued)
Care must be taken when operating this equipment adjacent to or stacked with other equipment. Potential electromagnetic or other interference could occur to this or other equipment. Try to minimize this interference by not using other equipment in conjunction with it. (i.e. cell phones, MRI, electro surgery, defibrillation, etc.)
Electronic monitoring equipment (such as ECG monitors and ECG alarms) may not operate properly when electrical stimulation is in use.
Before administering the AMPCARE ES™ waveform you should become acquainted with the operating procedures for each mode of treatment available, as well as the indications, contraindications, warnings and precautions. Consult other resources for additional information regarding the application of electrotherapy, Electrical Stimulation, and AMPCARE ES™.
Simultaneous connection of a patient to high frequency surgical equipment may result in burns at the site of the stimulator electrodes and possible damage to the stimulator.
Keep electrodes separated during treatment. Electrodes in contact with each other could result in improper stimulation or skin burns.
Electrodes should be inspected before each use for resistance (i.e. hydration level, tack, discoloration and impurities). Follow the manufacturing guidelines on electrode packaging.
Patients with an implanted neurostimulation device must not be treated with AMPCARE ES™ anywhere on their body. Energy from AMPCARE ES™ can be transferred through the implanted neurostimulation system, can cause tissue damage, and can result in severe injury or death.
Handle, clean and dispose of components and accessories that have come in contact with bodily fluids according to National, Local and Facility rules, regulations and procedures.
Only use the AMPCARE E Series Electrodes and accessories designed specifically for use with the AMPCARE ES™ Unit. 4
4.
Indications for Use and Intended Uses
Indications for Use for AMPCARE ES™ Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction. Intended Uses for AMPCARE ES™ The waveform is a square symmetrical biphasic waveform with the application for use on the musculature of the face. The intended uses are for prevention or retardation of disuse atrophy, for muscle re-education and for relaxation of muscle spasms in the treatment of swallowing musculature dysfunction in post-traumatic conditions or after neurological insult with impaired neuromuscular function. The AMPCARE ES™ waveform is a symmetrical biphasic waveform with the application for use on the swallowing musculature in the anterior portion of the neck. The AMPCARE ES™ therapy treatment intended uses are: Muscle re-education of the swallowing musculature in the treatment of dysphagia (swallowing problems) from any etiology except mechanical causes that would need surgical intervention (for instance, obstructing tumors). Non-mechanical causes of dysphagia include: neurological and muscle disorders; cardiovascular accidents; respiratory disorders with swallowing complications; iatrogenic conditions (conditions caused by surgery); fibrosis/stenosis arising from radiation; disuse due to stroke, intubation hypoxic encephalopathy, or birth-related anoxic injuries; and trauma to the head and neck. This device is a prescription device intended for use by or on the order of a physician or other licensed health professional.
5.
Contraindications
This device should not be used on patients with cardiac demand pacemakers or other implanted electronic devices.
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6.
Warnings
The long term effects of electrical stimulation are unknown.
Stimulation should not be applied over the carotid sinus nerves, particularly in patients with a known sensitivity to the carotid sinus reflex.
This device should not be used when cancerous lesions or infections are present in the treatment area.
Stimulation should not be applied over places where active range of motion is contraindicated (e.g. fractures, anastomosis).
Stimulation should not be applied transthorasically in that the induction of electrical current into the heart may cause cardiac arrhythmias.
Stimulation should not be applied transcerebrally.
7.
Precautions
Safety of powered muscle stimulation for use during pregnancy has not been established.
Caution should be used for patients with suspected or diagnosed heart problems.
Caution should be used for patients with suspected or diagnosed epilepsy.
Caution should be used in the presence of the following: o When there is a tendency to hemorrhage following acute trauma or fracture. o When individuals cannot give clear feedback. Patients may not indicate when current becomes uncomfortable. o Following recent surgical procedure when muscle contraction may disrupt the healing process. o Over a menstruating or pregnant uterus. o Over areas of the skin which lack normal sensation. 6
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 alternative conductive medium or an alternative electrode placement.
Electrode placement and stimulation settings should be based on the guidance of the prescribing practitioner.
Powered muscle stimulators should be kept out of the reach of children.
Powered muscle stimulators should be used only with the lead wires and electrodes recommended for use by the manufacturer.
Portable powered muscle stimulators should not be used while driving, operating machinery, or during any activity in which involuntary muscle contractions may put the user at undue risk of injury.
8.
Adverse Reactions
Skin irritation and burns beneath the electrodes have been reported with the use of powered muscle stimulators.
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9.
Nomenclature 1
3 2 5
4
6
3 7
10
8
9
11 12 13
14 8
Keypad and case 1.
Channels 1 and 2 – Lead wires connect in the respective ports.
2.
Operator LCD Panel – see items 15-24.
3.
Power On/Off Button – used to turn unit On or Off.
4.
Program Button – used to select electrical stimulation program.
5.
Pause Button – used to pause the treatment.
6.
Enter Button – used to enter the selected parameter.
7.
Channel 1 Intensity Up and Down Controls – used to increase or decrease Channel 1 intensity.
8.
Menu Up and Down Controls – used to modify selected parameters.
9.
Parameter Up and Down Controls – used to increase or decrease parameter increments.
10. Channel 2 Intensity Up and Down Controls – used to increase or decrease Channel 2 intensity. 11. Control Button Cover – used to maintain selected parameters. 12. LED Light Indicator – blinks when unit is administering current. 13. Belt Clip – attach to patient during therapy session. 14. Battery Compartment – push in and slide down to insert/replace batteries. Do not use rechargeable batteries.
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Liquid Crystal Display (LCD) 16
15
17
18 19
24 20
22
21
23
15. Channel 1 Intensity Indicator – shows the intensity of Channel 1 during therapy session. 16. Program Indicator (ESP1, ESP2, MANUAL) – shows the program selected. 17. Channel 2 Intensity Indicator – shows the intensity of Channel 2 during therapy session. 18. Preset or Manual Indicator – shows if the frequency and phase duration are preset or manually selected. 19. Synchronous Indicator – shows that Channel 1 and 2 will work synchronously if both are in use. 20. Duty Cycle Indicator – shows the activation/on time and rest/off time of the duty cycle. 21. Timer Icon and Treatment Timer – therapy session timer. 22. Waveform Indicator – symmetrical biphasic waveform fixed. 23. Pulse Rate Indicator – shows the frequency measured in Hertz. 24. Phase Duration Indicator – shows the phase duration measured in microseconds.
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10.
Specifications
Please read the following detailed specifications carefully before using the unit. Output Configuration – Dual channel electrically isolated with miniature safety connectors. Output Waveforms – AC Mode: Rectangular symmetrical biphasic with zero net DC. Intensity Control – Dual intensity potentiometers: Ch1 intensity up/down 20 steps, 0 to a maximum of 100mA* into 500Ω Ch2 intensity up/down 20 steps, 0 to a maximum of 100mA* into 500Ω Unit Dimensions – width x height x depth is 66 x 136 x 30.7 mm Standard Weight – 98 grams Power Source
–Two AA LR6 Alkaline Batteries – Do not use rechargeable batteries
Safety Recognition – Meets IEC/EN 60601-1 Waveform Specifications – is a symmetrical biphasic waveform. Output Mode Output Intensity Channel Mode Phase Duration Mode Selection Set Intensity Cycle Time Frequency Ramp Treatment Time Available on Channels *
electrodes 0-100mA* Single and Co-Contraction 50-250µsec Constant Charge Individual Channel Intensity Setting 5/15, 5/20 and 5/25 5-50 Hz 1 sec 5-30 minutes 1&2
Intensity setting controls output amperage, which is limited based on phase duration. Refer to page 14 of this manual for more detailed information. 11
Three mode features: a) Program Preset 1, ESP 1 – electrical stimulation program 1 Frequency Fixed, 30 Hz Phase duration Fixed, 50μs Waveform Symmetrical biphasic rectangular On time Fixed 5 sec Off time Adjustable 25 sec, 20 sec and 15 sec Ramp up Fixed 1 sec Ramp down Fixed 0 Treatment timer Fixed 30 min Intensity Adjustable 0 – 20* b) Program Preset 2, ESP 2 – electrical stimulation program 2 Frequency Fixed, 30 Hz Phase duration Fixed, 250μs Waveform Symmetrical biphasic rectangular On time Fixed 5 sec Off time Adjustable 25 sec, 20 sec and 15 sec Ramp up Fixed 1 sec Ramp down Fixed 0 Treatment timer Fixed 30 min Intensity Adjustable 0 – 20* c) Program Manual 3, Manual 3 – electrical stimulation program 3 Frequency Adjustable 5-50 Hz Phase duration Adjustable 50-250μs Waveform Symmetrical biphasic rectangular On time Fixed 5 sec Off time Adjustable 25 sec, 20 sec and 15 sec Ramp up Fixed 1 sec Ramp down Fixed 0 Treatment timer Adjustable 5-30 min Intensity Adjustable 0 – 20* *
Intensity setting controls output amperage, which is limited based on phase duration. Refer to page 14 of this manual for more detailed information. 12
Output: a. Waveform: Symmetrical biphasic rectangular waveform
Amplitude
Time
b. Output parameters: Detailed output parameters of the 2 preset programs and 1 manual program regarding to the frequency, phase duration, ramp up, ramp down, cycle on time, cycle off time, and program duration are as follows. Program table: Program Frequency (Hz) Phase Duration (μsec)
ESP1
ESP2
30 (fixed) 50 (fixed)
250 (fixed)
Manual 3 5-50 adjustable in 1 Hz increments 50-250 adjustable in 50 μsec increments
Ramp Up (sec)
1 (fixed)
Ramp Down (sec)
0 (fixed)
Cycle ON Time (sec)
5 (fixed)
Cycle OFF Time (sec)
Selectable values of 25, 20, or 15
Program Duration (min) Intensity
*
30 (fixed)
5 – 30 adjustable in 5 min increments
0 – 20 adjustable in increments of 1*
Intensity setting controls output amperage, which is limited based on phase duration. Refer to page 14 of this manual for more detailed information. 13
c. Intensity: The intensity can be increased/decreased by adjusting the intensity setting from 0 to 20. The intensity setting controls the output amperage and is dependent on the phase duration. The maximum amperage output is achieved at 50μsec phase duration with intensity at 20. The minimum amperage output is achieved at 250μsec phase duration with intensity at 1 (excluding 0 for which no amperage is output.) The table below shows numerical values obtained during bench testing for four specific intensity settings at each of the five available phase durations. Also shown is a graphical representation of the same data showing the values obtained during bench testing at each intensity value for all five phase durations. Intensity Table: (bench-testing data: 30Hz, 500 ohms) Intensity
50 μsec
100 μsec
150 μsec
200 μsec
250 μsec
5
30 mA
24 mA
20 mA
15 mA
16 mA
10
46 mA
36 mA
32 mA
30 mA
25 mA
15
68 mA
50 mA
42 mA
40 mA
35 mA
20
90 mA
66 mA
56 mA
50 mA
44 mA
Output versus Intensity at 50, 100, 150, 200, and 250 μsec
100
Max. Output @50 micro sec
90
Max. Output @100 micro sec 80
Max. Output @150 micro sec Max. Output @200 micro sec
70 Output (mA)
Max. Output @250 micro sec 60 50 40 30 20 10 0 0
1
2
3
4
5
6
7 8 9 10 11 12 13 14 15 16 17 18 19 20 Intensity setting (Amplitude)
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11. Markings and Labels
1. Ch 1 and Ch 2 output jacks Ch1 & Ch2 are both marked on the top of the unit with respect to the output channels. After inserting the lead wire plugs into both Ch 1 and Ch 2 jacks, please do not remove the plugs when the unit is working. Ensure that the unit is switched OFF before removing the plugs. 2. Battery These symbols, as marked in the battery compartment, indicate to use only the specified batteries: 2x1.5 Volt AA Alkaline (LR6). Do not use rechargeable batteries. and stand for Anode and Cathode respectively.[Type a quote from the change the formatting of the pull quo
1.5V AA BATTERY TYPE LR6
1.5V AA
3.
Label EMS Unit ™
Model: Ampcare ES
Rating: DC 3V Battery: 2x1.5 volt AA (LR6) CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN
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12.
Set Up
How to assemble your AMPCARE ES™ STEP 1
BATTERY INSTALLATION: Remove the battery cover and insert two batteries on top of fabric strap, as shown on the diagram inside the battery compartment. Replace the battery cover. Note: Your unit will not function if the batteries are inserted incorrectly. To check, press the button once and the LCD display will start up. After you have made this check, press the button again and hold for 3 seconds to switch the unit off. CAUTION: Replace with AA Alkaline 1.5 volt batteries (LR6). Do not use rechargeable batteries.
STEP 2
LEAD WIRE INSTALLATION: Decide whether you wish to use the unit with one lead or two. Unravel one or both leads and insert the plug(s) into either of the jacks at the top of the unit. If only using one lead, insert into the Ch1 jack as marked on the unit.
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Note: Red & Black fasteners on leads At the end of the leads supplied with your unit, you will find red and black adapters. These are the anode and cathode, respectively. The following general points are made for your information: 1. More sensation and stimulation tends to come from the black adapter (cathode). 2. Where applicable, place the black adapter over the weakest muscle belly; e. g. if using a submandibular placement on an individual with right hemiplegia, consider placing the black adapter on the right side. Note: Refer to the AMPCARE E Series Electrode Instruction Card contained within the electrode package for electrode preparation and lead wire attachment to the electrodes. After the electrodes are placed on the patient per the AMPCARE ESP™ Therapy System Certification Training Materials, turn the unit on by pressing the button once.
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13.
Operating Directions for Use
The Keypad
Key Functions The button allows the switching on or off of the unit when needed. Press it once to switch the unit ON. When the unit is ON, the unit can be switched OFF by pressing and holding the button for 3 seconds. If you wish to switch OFF the unit while it is supplying stimulation, you need to press and hold the button for 3 seconds. The button allows the selecting of a program from the Preset 1, Preset 2 or Manual 3 options. To change the program press and hold the _ button for 3 seconds. Whenever the button is activated, the intensity level of both channels automatically resets to 0. When the unit is ON but the intensity level of at least one channel is above 0, you can PAUSE the unit by pressing the button once. When PAUSED the output level of both channels will be zeroed and the symbol _ will be shown between Ch1 and Ch2 on the display. To restart the unit, press the button once and the intensity level of both channels will be progressively restored within 6 seconds. 18