TensCare Elise Instructions For Use Manual

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Instructions for use
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CONTENTS
INTELLIGENT CONTINENCE STIMULATOR
Section: Page
1 Elise Features: 4 2 Types of Incontinence: 5 3 Advantages of the Elise: 5 4 How Continence Stimulation Works: 6 5 Continence Programmes: 7 - 12 6 Cautions and Warnings: 13 7 Controls: 14 - 17 8 Screen Information: 18 9 Usage Memory: 19 10 Leads Alarm: 20 11 Troubleshooting: 21 12 Contents: 21 13 Using the Elise: 22 14 Probe Hygiene: 23 15 Anal Probe: 23 16 Charging the battery: 24 - 25 17 Consumables and Servicing: 26 18 Guarantee: 27 19 WEEE: 27
20 Technical Specications: 28 - 31
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INTRODUCTION
The Elise may help, if not cure, Stress, Urge or Mixed Incontinence.
The Elise was developed in conjunction with professional continence advisers, taking into account feedback from users of our existing products. The Elise offers the best results, is comfortable and easy to use.
HELPLINE
A helpline is available, Monday to Friday. Call:
+44 (0)1372 72 34 34
or email:
webenquiry@tenscare.co.uk
FEEDBACK
TensCare aim to give you the best possible product and service.
We listen to your suggestions and are constantly trying to improve our products. We also want to learn about the way our products are used, and the benets they give. If you have anything you would like to share with us, please contact:
feedback@tenscare.co.uk
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1. ELISE FEATURES
• Comfortable Stimulation
TM
The strength of the stimulation increases gradually, making the feeling very comfortable and in your control.
• Easy Start - One Touch Memory
The Elise has intelligent memory that enables the unit to remember the last programme and the strength setting used. At the press of only one button the strength level returning to 50% of the last level used.
• Clinically tested programmes
The programmes which have been preset into the unit have been clinically tested and proven to be highly effective.
• Safety Duration Override
A safety duration override feature has been incorporated into the Elise to ensure that the pelvic oor muscle is not overworked. This is set at twenty minutes after which time the unit will switch off. It is possible to alter the time in order to customise the unit to your needs.
• Usage Memory
The Elise has a Usage Memory which shows the length of time that the unit has been in use and the average level of strength utilised.
• Rechargeable Li-ion battery
The Elise is the rst electrotherapy unit to use a slimline Li-ion battery. It gives a long and slender prole in a well tried format.
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2. TYPES OF INCONTINENCE
There are three types of incontinence: Stress, Urge, and Mixed.
• Stress Incontinence
Describes the involuntary leakage of urine when a person coughs, sneezes, strains or makes sudden movements. It is particularly common in women and occurs when the bladder neck and the other mechanisms that act to hold urine in the bladder are not working properly.
• Urge Incontinence
Describes an overactive bladder. A person may experience a strong and sudden urge to go to the toilet but are not always able to hold on, or have to go so frequently that it becomes inconvenient.
• Mixed Incontinence
Is a combination of both Stress and Urge Incontinence.
3. ADVANTAGES OF THE ELISE
• It can reduce leakage – not simply contain it
• It is Drug Free with no side effects
• It is Safe and Easy to use
• It is Discreet
• It may help to avoid surgery and
• It may improve sexual intimacy
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4. HOW CONTINENCE
STIMULATION WORKS
The Elise, through a vaginal probe or pads, sends a gentle stimulation to your pelvic oor muscles using clinically recognised programmes. The Elise works the pelvic oor muscles for you and helps you to develop your own muscle control. It perfectly compliments pelvic oor exercises. The Elise is the result of considerable research and consultation with continence advisors.
It is also possible to treat faecal incontinence in both males and females using an anal probe.
Please note that we recommend the Liberty vaginal probe (as supplied with the unit) and accessories listed on page 26 as the unit has been tested with these.
In some instances, where a probe is not appropriate ­particularly with Urge Incontinence - it is possible to treat incontinence by using electrode pads placed on the body.
If in doubt contact your continence adviser before using the Elise.
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5. CONTINENCE PROGRAMMES
The Elise has four preset programmes. One for each type of incontinence and a fourth for toning of the pelvic oor muscles.
STRESS INCONTINENCE:
Shown on the screen as: “STRES”
The STRESS incontinence programme strengthens the muscles of the pelvic oor using gentle stimulation. Once muscular strength has been improved these muscles are better able to resist urinary leakage caused by external pressure being applied to the bladder such as with a cough, sneeze or physical exertion.
The stimulation causes the muscles to contract and work thereby building their strength.
Successful treatment requires stimulation once a day for one to three months. Improvement starts becoming apparent after about four weeks. It helps to keep a record of leakage problems so that you have an objective measure of your progress. The sensation is like a strong drawing in of the muscles of the vagina, pulling up of the pelvic oor. Your natural reaction will be to pull your muscles in and up, thereby exercising and strengthening them.
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URGE INCONTINENCE:
Shown on the screen as: “URGE”
The URGE incontinence programme reduces the involuntary contractions of the bladder (detrusor) muscle. This prevents the unwanted and unexpected emptying of the bladder.
Successful treatment will require stimulation once a day and improvements can be seen in as little as two weeks.
The sensation is of a longer and softer pulling in of the pelvic oor than the Stress programme.
When the programme nishes, and your pelvic oor relaxes, it will become apparent how much your situation has improved.
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MIXED INCONTINENCE:
Shown on the screen as: “MIXED”
This programme is perfect if you are suffering from both Stress and Urge incontinence or are not sure which form of incontinence is the problem. The stimulation frequency is midway between Stress and Urge.
The sensation, as you might expect, is like a combination of both the Stress and Urge programmes. The overall effect is not such a strong feeling as the Stress programme plus a slight pleasurable throbbing sensation.
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TONE:
Shown on the screen as: “TONE”
Having restored your pelvic oor muscles to an excellent condition you will want to keep them toned and strong. Regular use of this programme, about twice a week, will ensure that your muscles remain t and toned.
The TONE programme may also be used as an alternative treatment for STRESS.
The sensation when using the Tone programme is a mixture of a strong drawing in of the muscles and then releasing. The programme repeats the sensation. A strong and t pelvic oor muscle may increase sexual health and enjoyment.
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GENERAL POINTS
i) The Stress, Mixed and Tone programmes exercise the pelvic oor muscles. The sensation is like a strong drawing in of the muscles of the vagina, pulling up of the pelvic oor. The muscle MUST contract in order to give a benet.
Increase the strength as high as is comfortable, and then take it back down one step. The level required varies widely between users – some will use the Elise at full power – 99.5
ii) It is advisable not to ‘overdo’ it early on. As long as you can feel the contraction, it is working. You can build up slowly over a number of days. With the rst few sessions the muscles may ache the next day– the same reaction you would get with any unaccustomed exercise. With the pelvic oor, this gives a ‘cramping’ feeling. If this happens, stop using your Elise until the aching goes away, then start again using a lower strength and a shorter treatment time. As the pelvic oor begins to improve, it will be possible to maintain the stimulation for longer.
iii) The Urge programme works differently. There is no need to have a contraction. As long as you can feel the stimulation easily, it is working. You may need to increase the strength during the treatment session.
iv) For best results in the stress and mixed programmes try to contract the pelvic oor muscles along with the Elise, and to sustain the contraction into the rest interval. If possible, link the contraction to your breathing in order to get into a gentle rhythm.
v) Once the pelvic oor has been strengthened using the Elise, continue to exercise the pelvic oor muscles. The pelvic oor needs to be worked and reacts very well to such exercises.
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GENERAL POINTS (CONTINUED)
vi) The length of each session for muscle strengthening will also depend on your ability to contract and your resistance to fatigue. Be careful not to overuse early on, as the resulting aches may not be felt until the next day.
vii) All programmes cycle between "work" and "rest" to allow your muscles to recover in between contractions. During the "rest" period, the strength display ashes "000".
viii) When you change the strength setting, this cycle stays on "work" until you stop pressing the buttons for more than 5 seconds.
ix) The usages mentioned for each programme are guidelines only, and may be altered depending on your personal needs.
x) You may feel the stimulation through the probe more strongly on one side than the other.
A strong and t pelvic oor muscle may increase sexual health and enjoyment.
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6. CAUTIONS AND WARNINGS
Do NOT use the Elise under the following circumstances:
• If you have a heart pacemaker or a heart rhythm problem
• If you are pregnant
• If you have been diagnosed or treated for cervical, or any pelvic, cancer
• If you have, or have had epilepsy
• Whilst driving, or during any activity in which involuntary muscle contractions may put the user at undue risk of injury
• Within 12 weeks of surgery in the area. Scars should be fully healed before use
IF IN DOUBT, CONSULT YOUR PHYSICIAN.
BEFORE USE, PLEASE READ THE FOLLOWING WARNINGS:
• Incontinence can have many causes. You should try to identify the type of incontinence and the cause before using the Elise.
• If you have a urinary infection or any skin irritations within the vagina, it is recommended not to use the Elise.
• Care must be taken if you are not experiencing normal sensation or feeling in your vagina. Please see the section about inserting the probe.
• If you have a severe prolapse, or any discomfort occurs when inserting the probe, consult your medical advisor before use.
• If you use a copper IUD, stop use immediately if you experience discomfort. There is a very small risk of stimulation of the uterine wall if the IUD is not correctly located.
NB: You may safely use the stimulator during menstruation, although it may be a little less comfortable.
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7. CONTROLS
ON / OFF Button
Strength DOWN
Programme
Timer
Strength UP
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7. CONTROLS
ON / OFF Button
To switch unit ON: Press and hold down for 3 seconds.
When the unit is switched ON an audible “Beep” will be heard.
One Touch Memory Start When switched on the unit will automatically start in the programme which was being used when it was switched off. The strength returns to about 50% of the level that was being used when the unit was switched off. This simplies start up dramatically.
During start up to stop the increase in strength at any time, press any key once.
To switch unit off: Press and hold down the button for 3 seconds and the unit will switch off. When the unit switches OFF an audible double “Beep” will be heard.
NOTE: Always check unit is OFF before removing probe or pads.
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7. CONTROLS
Strength UP Button
To increase strength: Press and hold down until required strength is achieved. . Press and release to increase in soft and gentle 0.5 steps.
The unit will remain in the “Work” part of the cycle for 5 seconds while the strength is being adjusted
Strength DOWN Button
To decrease strength: Hold down button and strength will decrease steadily in 0.5 steps.
Programme Button
The Elise has specically selected programmes. When you FIRST switch on the unit automatically goes to programme STRES.
Next time it is switched on it will default to the programme last used.
Each time the “P” button is pressed and released the programme changes. The screen will show the programme selected
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7. CONTROLS
Time Selector button
Each time you switch on the Elise the length of time of your programme will automatically revert to 20 minutes.
During use the unit counts down the minutes which are shown on the screen. On reaching zero the unit will switch off.
By repeatedly pressing and releasing the Timer button you can manually override and select 10, 30, 45, 60, 90 minutes or continuous time.
The length of time that you have selected will be shown on the screen. The minutes will start to count down once you start the programme.
If you hold down this key for 3 seconds, you can PAUSE the timer, allowing you to interrupt the treatment session, and resume it later. Return to main screen by pressing any other key.
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8. SCREEN INFORMATION
Time Remaining (mins)
Programme
Strength
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9. USAGE MEMORY
The Elise has a usage memory which remembers the length of time and average strength that has been used.
To activate hold down the Time Selector and strength UP buttons together for 3 seconds. The screen will show the time in hours (to the nearest hour) and strength in mA.
Hold down Time Selector and strength DOWN button together for 3 seconds to reset the memory to zero.
Time in hours
Average strength
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10. LEADS ALARM
The Elise monitors the connection and the contact between you and probe, or pads.
If either of these goes outside of a standard range while the strength is above 20.0 , the unit will ash “LEADS”, bleep three times, and return strength to zero.
Check the lead and if necessary, lubricate the probe.
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11. TROUBLESHOOTING
If the unit does not work:
No display - charge battery.
No sensation - LEADS alarm. Check lead and probe lubrication.
No LEADS alarm - Dampen your hand with water and a little table
salt. Hold on to the probe and carefully increase strength. If you cannot feel anything, the unit may be faulty, therefore contact Tenscare or your local distributor.
12. CONTENTS
• Elise continence stimulator
• Liberty vaginal probe X-VP (for single patient use)
• Connecting Lead wire
• Li-ion battery type BL-4B
• Charging cradle
• Power adaptor
• Instruction booklet
• Transit pouch
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13. USING THE ELISE
Setting up and using the Elise is very simple.
Step 1: Inserting battery into unit:
To remove Battery Cover, press down in the centre of the battery cover and slide downwards. To insert battery, line up the 3 connectors on the battery with the contacts in the unit, slide in and press down. Replace the battery cover.
Step 2: Plug the connecting lead wire
into the Elise as shown right.
Step 3: Connect the other end of
the connecting lead wire to the probe.
Step 4: Insert the probe.
Please note:
• Before inserting the probe go to the toilet.
• Ensure the Elise is switched OFF before insertion.
• Lubricate the probe with a proprietary jelly, such as KY, or water.
• Insert the probe into the vagina, in the same way as a tampon, until only the ange at the end is visible. The probe will naturally position itself with the widest part of the ange vertically.
• Initially the sensation through the probe may be limited but will improve during treatment. Take care not to use too high a strength setting and thereby over stimulate the muscles. The sensation may not be even as it may vary depending on the sensitivity of the nerves.
• If using optional pads instead of the Liberty probe for Urge, place the pads either side of the spine, as low as possible.
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14. PROBE HYGIENE
The Liberty vaginal probe that is supplied with the Elise is intended strictly for single patient use. It is important that the probe is cleaned after each use. Clean with either an antibacterial wipe or by washing in warm soapy water, rinse and dry thoroughly.
The vaginal probe should be replaced every six months. For best results, use only the Liberty replacement vaginal probe.
15. ANAL PROBE
An anal probe (X-VP or X-PR13A) can be purchased as an accessory.
This probe can be used for faecal incontinence in both males and females.
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16. CHARGING THE BATTERY
The Elise is powered by a type BL4B rechargeable Li-ion battery.
A separate Charging Cradle and Power Adaptor are included in the kit.
The battery should need charging about once a month.
When the battery is running low, a low battery indicator will show on the screen (battery symbol).
Although the display fades as the batteries run down, the strength of the output does not change until the warning is shown.
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NB: Remove the battery from your Elise if the unit is unlikely to be used for a long period
When the battery is charged, the indicator light on the cradle will change from red to green.
For a replacement battery, contact Tenscare or your local distributor.
Use only the power adaptor and charging cradle supplied.
USE OF OTHER CHARGERS COULD BE HAZARDOUS AND WILL NEGATE THE GUARANTEE
Warning
There is a risk of smoke, re, or rupture if the battery is not used according to the following guidelines:-
Do not disassemble the battery
Do not short-circuit the battery
Do not incinerate or heat the battery
Do not use or leave battery near a re, stove or
heated place (more than 80°C)
Do not immerse the battery in water or sea water, or get it wet
Do Not charge battery nearby the re or in strong sunlight
Only use the charger provided and observe charging instructions
Disposal
Always dispose of batteries responsibly according to local government guidelines.
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17. CONSUMABLES AND SERVICING
PART NUMBER:
X-VP Liberty Vaginal probe L-IT1 Replacement lead 1.25m X-PR13 PR13A Anal Probe* X-AP Anuform anal probe* E-CM5050 Electrode pads 50x50mm for external use. Pack of 4* B-BL4B Li-ion battery
*Supplied as an accessory
These consumables can be purchased either by contacting TensCare on +44 (0)1372 72 34 34, by going online to www.tenscare.co.uk, or from your local supplier. Please ensure that you order the correct part number.
For servicing please call Tenscare on +44 (0)1372 72 34 34 to discuss any problem.
If your unit needs to be returned please send it to:
Service Department, TensCare Ltd, 9 Blenheim Road, Epsom, Surrey KT19 9BE United Kingdom
Please ensure that you enclose your name, address and contact telephone number so that you can be contacted and informed about any problem and any costs involved.
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18. GUARANTEE
Your Elise is guaranteed for two years from the date of purchase. If a fault develops contact Tenscare or your local distributor.
The guarantee does not cover probe, pads (optional extra), battery, or the mono lead wire.
Please note that the Guarantee is invalidated if: i) incorrect battery has been tted ii) the unit has been immersed in water, maltreated or tampered with.
19. DISPOSAL OF WASTE
ELECTRICAL AND ELECTRONIC PRODUCTS (WEEE)
One of the provisions of the European Directive 2002/96/CE is that anything electrical or electronic should not be treated as domestic waste and simply thrown away. To remind you of this Directive, all affected products are now being marked with a crossed-out wheelie bin symbol, as depicted above .
To comply with the Directive you can return your old electrotherapy unit to us for disposal. Simply print a postage-paid PACKETPOST RETURNS label from our website www.tenscare.co.uk, attach this to an envelope or padded bag with the unit enclosed, and post it back to us. Upon receipt we will send your old device for components recovery and recycling to help to conserve the world's resources and minimise any adverse effects on the environment.
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20. TECHNICAL SPECIFICATION
GENERAL SPECIFICATION
Max Intensity: 50V zero to peak. Setting 0-100 in steps of 0.5 OC cutout below 160 Ohm. Constant current 160-470 Ohm 470-2000 Ohm constant voltage
Channels: Single
Waveform: Asymmetrical rectangular
Max Pulse energy: Total output limited to 25uC per pulse
Power: BL-4B Li-ion battery 3.7V
Battery life: At least 15 hours at 50mA 300uS 50Hz
Adjustable Timer: 10, 20, 30 45, 60, 90 min Defaults to 20 min
Output plug: Fully shielded: touch proof mini USB
Weight: 90 gms without battery
Dimensions: 100 x 65 x 18 mm
Safety Classication Internal power source
Type BF Designed for continuous use. No special moisture protection.
Environmental Operating Humidity: 20 to 65% RH Specications: Temperature range: 0 to 35C Storage Specications: Humidity: 10 to 90% RH
Temperature range: 0 to 55C
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20. TECHNICAL SPECIFICATION
TYPE BF EQUIPMENT Equipment providing a degree of protection against electric shock, with isolated applied part.
This symbol on the unit means “Refer to Instruction Manual”
NB: The electrical specications are nominal and subject to variation from the listed values due to normal production tolerances
PROGRAM SETTINGS Prog Hz Pulse Ramp Plateau Off Default
Width Up & (Sec) (Sec) Program (uS) Down Duration
(Sec) (Min) STRES 50 300 1 5 10 20 URGE 10 200 1 5 10 20 MIXED 20 250 2 5 10 20 TONE 35 250 2 3 6 20
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Use special precautions regarding EMC according to the information provided below.
Other portable and mobile RF communications equipment can affect performance.
Do not use when adjacent to or stacked with other electrical equipment.
Use of leads or probes other than those listed in section
18 may affect EMC performance.
Guidance and manufacturer’s declaration - electromagnetic emissions
The Elise is intended for use in the electro magnetic environment specified below. The custom er or the user of the Elise should assure that it is used in such an e nvironment.
Emissions test
Compliance
Electromagnatic environment - guidance
RF emissions CISPR 11
Group 1
The model Elise uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11
Class B
The model Elise is suitable for used in domestic establishment and in establishment directly connected to a low voltage power supply network which supplies buildings used for domestic purposes.
Harmonic emissions IEC61000-3-2
Not applicable
Voltage fluctuations/ flicker emissions IEC 61000-3-3
Not applicable
The Elise is intende d for use in the electrom a gnetic environment s p ecified below. The customer or the user of the Elise should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment guidance
Electrostatic discharge (ESD) IEC 61000-4-2
±6 kV contact ±8 kV air
±6 kV contact ±8 kV air
Floors should be wood, concrete or ceramic tile . If floors are covered with synthetic m aterial, the relative humidity should be at least 30 %.
Electrical fast transient/burst IEC 61000-4-4
±2 kV for power supply lines ±1 kV for Input/output lines
Not applicable
Not applicable
Surge IEC 61000-4-5
±1 kV differential mode ±2 kV common mode
Not applicable
Not applicable
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11
<5 % UT (>95 % dip in UT) for 0,5 cycle 40 % UT(60 % dip in U
T
) for 5 cycles
70 % U
T
(30 % dip in UT )for 25 cycles
<5 % U
T
(>95 % dip in UT ) For 5s
Not applicable
Not applicable Power frequency (50/60 Hz)
magnetic field IEC 61000-4-8
3 A/m
Not applicable
Not applicable NOTE UT is the a.c. mains voltage prior to application of the test level
20. TECHNICAL SPECIFICATION
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Recommended separation distances between portable and mobile RF communications equipment and the Elise
The model Elise is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the model Elise can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the model Elise as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of transmitter W
Separation distance according to frequency of transmitter M
150kHz to 80MHz
d=1.2
P
80 MHz to 800 MHz
d=1.2
P
800MHz to 2.5GHz
d=2.3
P
0.01
0.12
0.12
0.23
0.1
0.38
.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meter s (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power r a ting of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
The Elise is intended for use in the electromagnetic environment specified below. The customer or the user of the Elise should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance Level
Electromagnetic environment – guidance
Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3
3 Vrms 150 kHz to 80 MHz
3 V/m 80 MHz to 2,5 GHz
3 Vrms
3 V/m
Portable and mobile RF communications equipment should be used no closer to any part of the model Elise, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter
Recommended separation d istance
3V d = 1.2
P 80M Hz to 800MHz
d = 2.3
P 800MHz to 2.5GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicin ity of equipment marked with the symbol on the left of this box
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a. Field strengths from fixed transmitters , such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electro magnetic site survey should be considered. If the measured field strength in the location in which the model Elise is used exceeds the applicable RF compliance level above, the model Elise should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the model Elise. b.Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
20. TECHNICAL SPECIFICATION
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DISTRIBUTED BY:
Manufactured by: Tenscare Ltd
9, Blenheim Road, Epsom,
Surrey KT19 9BE, United Kingdom
TEL: +44(0) 13 72 72 34 34
FAX: +44(0) 13 72 74 54 34
e-mail: webenquiry@tenscare.co.uk
web: www.tenscare.co.uk
Pub Ref : I-EL-UK Rev 1.0 06/11
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