Drive Medical AMS-4 User manual

C
M
Y
K
PortWashington,NY11050
V1.3
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INDEX
Chapter Contents Page
Index ...................... .1
1. Introduction .... 2
2. Cautions ........ 3
3. Warnings .... 4
4. General Description ..... 4
5. Construction ....... ..5
6. Technical Specifications.. ..... .6
7. Replaceable Parts .... .7
8. Accessories .... 7
9. Graphic Symbols ....... ..8
10.Parameter Controls ........ .8
11.Attachment of Electrodes Lead Wires .... 10
12.Lead Wire Maintenance .... ..11
13.Electrode Options ...... ..11
14.Electrode Placement ...... 11
15.Tips For Skin Care ..... 13
16.Application of Re-usable Self Adhesive Electrodes .... .13
17.Adjusting the Controls ..... .14
18.Battery Information .... 18
19.Maintenance, Transportation and Storage of
EMS Device........................................................................19
20.Safety Control ... .. 20
21.Malfunctions ... . 20
22.Conformity to Safety Standards .... 21
23.Warranty ..... .21
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EMS is not recommendedfor patientswith knownheart disease without physi-
cal evaluation of risk. Do not use EMS on the carotid sinus(neck) region. Do no
apply EMS for undiagnosed pain syndromes until etiology is established. Do
not stimulate on the site that maycause current to flowtranscerebrally(through
thehead).
3.Adverse Reactions
Possible allergic to gel, skin irritationand electrode burn are potential adverse
reactions.
4.Read operation manual before use of EMS.
5.We emphasize that patient with an implanted electronic device (for example, a
pacemaker)shouldnotundergoEMStreatmentwithoutfirstconsultingadoctor.
Thesame appliesto patientswith any metallic implants.
6.If EMS therapy becomes ineffective or unpleasant, stimulation should be dis-
continued until its use is reevaluated by the physician or therapist.
7.Avoid adjustingcontrols while operating machineryorvehicles.
8.Turn the EMS off before applying or removing electrodes.
9.EMS devices have no AP/APG protection.
Do not use it in thepresence of explosive atmosphere and flammable mixture.
Chapter 3 : WARNINGS
1.Caution should be used in applying EMS to patients suspected of having
heart disease. Further clinical data is needed to show there are no adverse
results.
2.The safety of EMS devices for use during pregnancy or birth has not been
established.
Do not use EMS during pregnancy.
3.EMS is not effective for pain of central origin. (This includes headache.)
4.EMS devices should be used only under the continued supervision of a
physician.
5.EMS devices have no curative value.
6.EMS is a symptomatic treatment and as such suppresses the sensation of
pain which would otherwise serve as a protective mechanism.
Chapter 1 : INTRODUCTION
EXPLANATION OF EMS
ElectricalMuscleStimulationisaninternationallyacceptedandprovenwayoftreat-
ing muscular injuries.It works bysending electronic pulses to the muscle needing
treatment; this causes the muscle to exercise passively.
Itisaproductderivedfromthesquare waveform,originallyinvented byJohnFara-
dayin 1831. Throughthe square wave pattern it is able to work directly on muscle
motor neurons. EMS has low frequency and this in conjunction with the square
wave pattern allows direct work on muscle groupings. This is beingwidely used in
hospitals and sports clinics for the treatment of muscular injuries and for the re-
education of paralyzed muscles, to prevent atrophy in affected muscles and im-
proving muscle toneand blood circulation.
HOW EMS WORKS
EMS is intended to be used to increase blood circulation and loosens tight and
knotted fibers, stimulates muscle growth and also reduces stiffness in muscle
joints. The EMS units send comfortable impulses through the skin that stimulate
the nerves in the treatment area. When the muscle receives this signal it con-
tracts as if thebrain has sentthe signal itself.As thesignal strengthincreases,the
muscle flexes as in physical exercise. Then when the pulse ceases, the muscle
relaxes and the cycle starts over again, (Stimulation, Contraction and Relaxation.)
Chapter 2 : CAUTIONS
1.Precautions:
Isolated cases ofskin irritation may occur atthe site of electrode placement
following logn-term application. Effectiveness is highlydependent upon patient
selection by a person qualified in the management of pain patients.
2.Contradictions:
EMS devices can affect the operation of demand type cardiac pacemakers.
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Chapter 5 : CONSTRUCTION
7. Electronic monitoring equipment (such as ECG monitors and ECG alarms)
may not operate properly when EMS stimulation is in use.
8. There should be a prominently placed statement warning that stimulus
delivered by this device may be sufficient to cause electrocution. Electrical
current of this magnitude must not flow through the throax because it may
cause a cardiac arrhythmia.
9. Do not place electrodes on the front of the throat as spasm of the Laryngeal
and Pharyngeal muscle may occur.
10.Care should be taken so that when operating potentially dangerous ma-
chinery the stimulator controls are not changed abruptly.
6. Electrodes should not be placed over the eyes, in the mouth, or internally.
11. Keep this device out of the reach of children.
12.Caution: Federal law restricts this device to sale by or on the order of a
physician.
Chapter 4 : GENERAL DESCRIPTION
The AMS-4 EMS is a battery operated pulse generator that sends electrical
impulses through electrodes to the body and reaches the underlying nerves or
muscle group. The device is provided with two controllable output channels,
each independent of each other. An electrode pair can be connected to each
output channel.
The electronics of the AMS-4 EMS create electrical impulses whose Intensity,
Pulse Width, Pulse Rate, Contraction, Relaxation and Ramp may be altered
with the switches. Dial controls are very easy to use and the slide cover pre-
vents accidental changes in the setting.
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Chapter 7 : REPLACABLE PARTS
The replaceable parts and accessories of EMS devices are as given below
Except leads, electrodes and battery, battery case cover, please do not try to re-
place the other parts of a device.
PARTS
01 ELECTRODES LEADS
02 ELECTRODES
03 9V BATTERY ,TYPE 6F22
04 BELT CLIP
05 BATTERY CASE COVER
06 LEAD CONNECTOR
07 MAINPCB
08 INTENSITY KNOB
09 CONTRACTION KNOB
10 RELAXATIONKNOB
11 PULSEWIDTHKNOB
12 PULSE RATE KNOB
13 RAMPKNOB
Chapter 8 : ACCESSORIES
Each set AMS-4 EMS are completed with standard accessories and standard
label as given below
I. Accessories
REF. NO. PRODUCT Q’TY
AGF-101 40X 40 MMAdhesiveElectrodes 4 pieces
AGF-110 Electrodes Leads 2 pieces
9 V Battery 1 piece
InstructionManual 1 piece
Carrying Casex 1 EA 1piece
Chapter 6 : TECHNICAL SPECIFICATION
The technical specification details of AMS-4 EMS are as follows.
MECHANISM TECHNICALDESCRIPTION
01. Channel Dual, isolated between channels.
02. Intensity Control Adjustable, 0-80 mA peak into 500 ohm load
eachchannel
03. WaveForm Asymmetrical Bi-Phase Square Pulse
04. Voltage 0 to 34 V (Load : 500 ohm)
05. PowerSupply One9Vbattery
06. Size 95(H) x 65(W) x 23.5(T) mm
07. Weight 115 grams with battery
08. Pulse Rate Adjustable, from 2 to 150 Hz
09. PulseWidth Selectable 100uS, 200uS, and300 uS
10. Contraction Time Adjustable from 1-30 seconds
11. RelaxationTime Adjustable from 1-45 seconds
12. Ramp Time Adjustable from 1-8 seconds
13. Max. Charge perpulse 20 micro-coulombs
14. Battery Life Approximately 25 hours at nominal settings.
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ing directly through the area of pain or localized enervation), a quick pulse rate
(setting greater than 80Hz on the Pulse Rate Control) is desired. The patient
should not perceive individual pulses but rather have the sensation of steady
continuous stimulation.
When using point treatments, it has been suggested that slow pulses be
utilized (less than 10Hz). With this setting the patient should be able to slightly
perceive individual pulses.
When using multiple electrode placement strategies, such as combinations of
pointandcontiguouselectrodeplacements,thequickerpulseratesaresuggested.
Despiteaboverecommendations,theseindividualpatientsmayrequireslightvaria-
tions of the above settings, according to the nature of their condition.
INTENSITY
Each patient responds differently to differentlevels of intensity, due to varying de-
grees of tissue resistance, enervation, skin thickness, etc. Intensity instructions
are therefore limited to the following settings:
Perception The intensityis increased so that the patientcan feelthe stimulation,
but thereis not any muscular contraction.
Slight Contraction Intensity is increased to a barely visible muscular contraction
that is not strongenough to move a joint. When usinglow pulse rate settings, this
will show as individual twitches. At higher pulse rates there will simply be in-
creased muscle tension.
Strong muscular contraction is may be useful in spastic muscle group. The EMS
can be used in the circumstances to quickly break the spasm. Use a quick pulse
rate, wide pulse duration and set the intensity to visible contraction (still within
patient tolerance). Twenty orthirtyminutes of such a tetanized muscular contrac-
tion will generally break the spasm. In all cases, if the patient complains that the
stimulation is uncomfortable, reduce intensityand cease stimulation.
CONTRACTION/RELAXATION
The contraction time and relaxation time of EMS is adjustable.
II.LABEL The label attached to the back of device
contains important message about this
device- model, serial number, supply
voltage, the name of manufacturer, CE
number and classification. Please do not remove.
Chapter 9 : GRAPHIC SYMBOLS
1. Note Operating Instructions
2. Degree of Electrical Protection BF
3. Do not insert the plug into AC power supply socket
4. Direct Current (DC power source)
Chapter 10 : PARAMETER CONTROLS
PULSE DURATION
Wider pulse duration settings will deliver stronger stimulation for any given inten-
sity setting. As mentioned in the Controls section, by using a combination of
intensityandpulseduration,itisfeltthat variouspulsewidthsarecapableofstimu-
lating different muscles groups.
The wider pulse duration is needed to recruit motor fibres, whereas the narrow
pulse duration is used on themore sensoryfibres.
PULSE RATE
The Pulse Rate (hertz or pulses per second) chosen depends greatly upon the
type of electrode placement given to the patient.
When using contiguous and dermatome electrode placements (i.e. stimulat-
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CAUTION
Do not insert the plug of the patient lead wire into the AC power supply socket.
Chapter 12: LEAD WIRE MAINTENANCE
Clean the wires by wiping with a damp cloth. Coating them lightly with talcum
powder will reduce tangling and prolong life.
Chapter 13 : ELECTRODE OPTIONS
Your clinician will decide which type of electrode is best for your condition. Follow
application procedures outlined in electrode packing, to maintain stimulation and
prevent skin irritation. Use thelegally marketed EMS electrode is recommended.
The device is completed with standard carbon film adhesive electrodes in size
5x5cm.
Chapter 14 : ELECTRODE PLACEMENT
The placement of electrodes can be one of the most important parameters in
achieving success with EMS therapy. Of utmostimportance isthe willingness of
the clinician to try the various styles of electrode placement to find which method
best fits the needs of the individual patient.
Every patient responds to electrical stimulation differently and their needs may
vary from the conventional settings suggested here. If the initial results are not
positive,feelfreetoexperiment. Onceanacceptableplacementhasbeenachieved,
mark down the electrodes sites and the settings on the patient’s Reference sheet
of this manual, so the patient can easily continuetreatment at home.
CONTIGUOUS PLACEMENT
This is the most common placement technique. It involves placing the elec-
Stimulation will continue at the setting contraction time and cease also at the
setting relaxation time. Then the cycle starts over again Stimulation, Contrac-
tion and Relaxation.
RAMP
In order to achieve a comfortable exercise and avoid startle because of electrical
shock,eachcontractioncoursemayberampedsothatthesignalcomes ongradu-
ally and smoothly. The intensity of electrical current will reach the setting level
within the Ramp time, however, it can not reach the expected level if the contrac-
tion time is less than the ramp time.
TIME DURATION
EMS units are typically operated for long periods of time, with a minimum of 20
30 minutes. However,the time is varied subject to the treatment required. Please
consult your physician before use of EMS.
11 : ATTACHMENT OF ELECTRODE LEAD WIRES
The wires provided with the system insert into the jack sockets located on top of
thedevice. Holdingtheinsulatedportionoftheconnector,pushtheplugendofthe
wire into one of the jacks (see drawing); one or two sets of wires may beused.
After connectingthe wiresto the stimulator,attach each wire to an electrode. Use
care when you plug and unplugthe wires. Jerking the wireinstead of holding the
insulated connector body maycause wire breakage.
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Chapter 15 : TIPS FOR SKIN CARE
Toavoidskinirritation,especiallyifyouhavesensitiveskin,followthesesuggestions:
1.Wash the area of skinwhere you will be placing theelectrodes, using mild soap
andwaterbeforeapplyingelectrodes,andaftertakingthemoff. Besure torinse
soap offthoroughlyand dryskin well.
2.Excess hair may be clipped with scissors; do not shave stimulation area.
3.Wipe the area with the skin preparation yourclinician has recommended. Let
this dry. Apply electrodes as directed.
4.Many skin problems arise from the “pulling stress”from adhesive patches that
are excessively stretched across the skin during application. To prevent this,
applyelectrodes from centre outward; avoid stretching over the skin.
5.To minimize “pulling stress”, tape extra lengths oflead wires to the skin in a loop
to prevent tugging on electrodes.
6.When removing electrodes, always remove bypulling in the direction of hair
growth.
7. It may be helpful to rub skin lotion on electrode placement area when not wear-
ingelectrodes.
8.Never applyelectrodes over irritated or broken skin.
Chapter 16: APPLICATION OF RE-USABLE SELF
ADHESIVE ELECTRODES
Application
1.Clean and dry the skin at the prescribed area thoroughly with soap and water
prior to application of electrodes.
2.Insert the lead wire into the pin connector on the pre-wired electrodes.
3.Remove the electrodes from the protective liner and applythe electrodes firmly
to the treatmentsite.
Removal
1.Lift at the edge ofelectrodes andpeel; do not pull on the lead wires because it
may damage the electrodes.
trodes alongside the affected muscles or muscle groups, in such a way as to
direct the flow of current through or around the area.
DERMATOMES, MYOTOMES AND SCLEROTOMES
Thesearetheregionsofthe bodyenervatedbyonespinalnerve. Electrodeplace-
ment involves both stimulating across the similarlyenervated area and/or placing
oneelectrode (orset ofelectrodes) at the affected site and another electrode (set)
at the pointwhere the nerve root joinsthe spinal cord.
MOTOR, TRIGGER AND ACUPUNCTURE POINTS
Whilethese points ofhightissueconductivitycan differ in locationand intheoryof
use, their use as an electrode site is identical. The easiest technique involves
placing one pad directly over the point and completing the circuit by placing the
second pad on some area on the affected side. This second electrode site can
be within a nerve zone, or a master point located between the thumb and the
forefinger on the dorsal web area between the two metacarpal bones.
MULTIPLE PLACEMENT STRATEGIES
Because the EMS has two independently operated channels, the clinician may
take advantage of concurrent pad placement strategies.
For example, it is possible to use two different electrode placement strategies at
the same time. One channel can be used to directly stimulate the pain site in a
contiguousmanner;theotherchannelcanbeplacedalongtheinvolveddermatome
or utilized for point therapy.
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2.Display Led
Each of the leds illuminates whenever the electronics of the device create a
current impulseat contraction timeand doesnotilluminatewhenthestimulation
is ceasedat relaxation time. Due tothe capacityof the human eye, the illumina-
tion of the lamp can only berecognized up to a frequencyof approximately 30
Hz. At higher frequencies, the lamp will appear to be constantly illuminated.
3.On/Off Switch and Intensity Controls:
If both controls are inthe off-position (white markings on the housing), the de-
vice is switched off.
By turning the controlsclockwise, the appropriate channel is switched on and
the impulse displayledwill illuminate and begin to pulseaccording to the fre-
quencyset.
The current strength of the impulses transmitted to the electrodes increases
further when the control isturned clockwise.
To reduce the current strength or switchthe device off, turn the control counter
clockwise to the required setting or off-position, respectively.
4.LeadConnector
Connection of the electrodes ismade withtwo-leadconnector.The devicemust
be switchedoff before connecting the cables. Both intensity controls must be at
the Off position. Electrodes must be pressed firmly on the skin.
2.Place the electrodes on the liner and remove the lead wire by twisting and
pulling at the same time.
Care and Storage
1.Between uses, store the electrodes in the resealed bag in a cool dry place.
2.It may be helpful to improve repeated application by spreading a fewdrops of
cold water over the adhesive and turn the surface up to air dry. Over Saturation
with water will reduce the adhesive properties.
Important
1.Do not apply to broken skin.
2.The electrodes shouldbe discarded when they are nolongeradhering.
3.The electrodesare intended for single patientuse only.
4.If irritationoccurs, discontinue use and consult your clinician.
5.Read the instruction foruse of self-adhesive electrodes before application.
Chapter 17 : ADJUSTING THE CONTROLS
1.SlideCover:
A slide-on panel covers the controls for Contraction
Time, Relaxation Time, Ramp Time, Pulse Width, and
Pulse Rate. Your medical professional may wish to
set t hese controls for you and request that you leave
the cover in place.
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8. RelaxationTimeControl
This dial determines the time of relaxation. The stimulation ceases at setting
relaxation time and then re-start in a cycle pattern. The relaxation time of both
channels is changed byturning this dial.The range of it is adjustable from 1
second to 45 seconds.
9. Ramp Time Control
This dial controls the time intensityof current output that increases from 0 to
the setting level. When the ramp time is set, each contraction maybe ramped
inorder thatsignals come on graduallyand smoothly.Theramp time isadjust-
able from 1 to 8 seconds byturning this switch.
10. Check/Replace the Battery:
Over time, in order to ensure the functional safety of EMS,
changing the battery is necessary.
1.Make sure thatboth intensity controls are switched to off-
position.
5.Pulse Rate Control:
This dial determines howmanyelectricalimpulses are applied through the skin
each second. Byturning these controls, the number of current impulses per
second (Hz) forboth channels can be continually adjusted. Unless otherwise
instructed, turn thepulse rate control to the 70-120 Hzrange.
6.PulseWidth Control:
This dial adjusts the length of time. Each electrical signal is applied through the
skin, which controls the strength and sensation of the stimulation. There are 3
Pulse Widths of options 100, 200 and 300 uS, Push the dial until the desired
position is reached.
7.Contraction Time Control
The contraction time control adjusts the time of stimulation. By turning this
control, the contraction time can be pre-set. The range is adjustable from 1
second to 30 seconds. The contraction time of EMS device can be adjusted by
turning this dial.
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To ensure optimum battery performance, follow these guidelines:
(a) Although overcharging the batteries for up to 24 hours will not damage
them, repeated overcharging may decrease useful batterylife.
(b) Always store batteries in their chargedcondition. After abattery has been
discharged, recharge it as soon as possible. If the batteryis stored more
than 60 days,it mayneed to be recharged.
(c) Do not short the terminals of the battery. This will cause the battery to get
hot and can cause permanentdamage. Avoid storing the batteries in your
pocket or purse where the terminals may accidentally come into contact
with coins, keys or any metal objects.
(d) WARNINGS:
1.Do not attempt to charge any other types of batteries in your charger,
otherthan the nickel-cadmium rechargeable batteries. Other types of
batteries may leak or burst.
2.Do not incinerate the rechargeable batteryas it may explode!
hapter 19: MAINTENANCE, TRANSPORTATION
AND STORAGE OF EMS DEVICE
1.Non-flammable cleaning solution is suitable for cleaning the device.
Note: Do not smoke or work withopen lights (forexample, candles, etc.)
when working with flammable liquids.
2.Stains and spots can be removed with a cleaning agent.
3.Do not submerge the device in liquids or expose it to large amounts of water.
4.Return the device to the carrying boxwith spongefoamto ensurethat the
unit is well-protected before transportation.
5.If the device is not to be used for a long period of time, remove the batteries
from the battery compartment (acid may leak from used batteries and
damage the device). Put the device and accessories in carrying boxand
keep it in cool dryplace.
6.The packed EMS device should be stored and transported under the tem-
perature range of -20°C ~ + 60°C , relative humidity 20% ~ 95% , atmo-
sphere pressure 500 hPa ~ 1060 hPa.
2.Slide the battery compartment cover and remove.
3.Remove the battery from the compartment.
4.Insert the battery into the compartment. Note the
polarity indicatedon the battery and in the
compartment.
5.Replace the batterycompartment cover and slide
to close.
Chapter 18 : BATTERY INFORMATION
AMS-4 EMS can be used with a rechargeable battery when necessary.
If you use rechargeable batteries, please follow the instructions.
RECHARGEABLE BATTERIES:
Prior to the use of a new unit, therechargeable batteryshould be charged accord-
ing to the battery manufacturer’s instructions. Before using the battery charger,
read all instructions and cautionary markings on the batteryand in this instruction
manual.
After being stored for 60 days or more, the batteriesmay lose their charge. After
long periods of storage, batteries should be charged prior to use.
BATTERY CHARGING
(1) Plugthe charger into any working 110or 220/240vmains electricaloutlet. The
use of anyattachment not supplied with the charger may result in the risk of
fire, electric shock, or injury to persons.
(2) Follow the battery manufacturer’s instructions for charging time.
(3) After the battery manufacturer’s recommended charging time has been
completed, unplug the charger and remove the battery.
(4) Batteries should always be stored in a fully charged state.
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Chapter 22 Conformity to Safety Standards
STATEMENTOFEMC
The AMS-4 EMS devices are in compliance with IEC 60601-1-2: 1993.
CONFORMITY TO MDD REQUIREMENTS
The AMS-4 EMS devices are in compliance with
IEC60601-1 safety standard and FDA 510K standards.
Chapter 23 : WARRANTY
All AMS-4 EMS models carry a warranty of three year from the date of
delivery. The warranty applies to the stimulator only and covers both parts and
labour relating thereto.
The warranty does not applyto damage resulting from failure to followthe
operating instructions, accidents, abuse, alteration or disassembly by unautho-
rized personnel.
Manufacturer: MEDICAL DEPOT INC DBA DRIVE MEDICAL
99 Seaview Boulevard
Port Washington, NY 11050
Phone # : [phone]
Edition : V1.3
Printed in February , 2007
Chapter 20: SAFETY-TECHNICAL CONTROLS
For safety reasons, check your AMS-4 EMS each week based on the following
checklist.
1.Check the device for external damage.
- deformationof thehousing.
- damaged or defective output sockets.
2.Check the device for defective operating elements.
- legibility ofinscriptions and labels.
- make sure the inscriptions and labels are not distorted.
3.Check Led
- led must be illuminated when switched on.
4.Check the usability of accessories.
- patientcableundamaged.
- electrodesundamaged.
Please consult your distributor if there are any problems with device and
accessories.
Chapter 21 MALFUNCTIONS
Should any malfunctions occur while using the EMS, check
- whether the switch/control is set to the appropriate form of therapy. Adjust
the control correctly.
- whether the cable is correctly connected to the device.The cables should be
inserted completely into the sockets.
- whether theimpulsedisplayledisilluminated.Ifnecessary,inserta newbattery.
- for possible damage to the cable. Change the cable if any damage is detected.
* If thereis any other problem, please return the device to yourdistributor. Do
not try to repair a defective device.
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