Contents Introduction ......................... 4 Contraindications, Warnings and Cautions ............. 5 IFT: What It Is and How It Works .................. 9 Keypad and Display ....................11 Contents ........................15 How to Assemble Your Unit ..................16 Operation ........................18 Programmes ....................... 22 Electrode Pad Placement ..................
Page 3
Symbols Used TYPE BF APPLIED PART: Equipment providing a degree of protection against electric shock, with isolated applied part. Indicates that this device has conductive contact with the end user. This symbol on the unit means “Refer to instructions for use”. Temperature Limitation: indicates the temperature limits to which the medical device can be safely exposed.
Page 4
This medical device is indicated for home use. A Contraindication is used when a device should not be used because the risk of use clearly outweighs any foreseeable benefits and may result in serious injury or death. A Warning is used when failure to follow the instructions may result in serious injury or death.
As a result, these two currents will superimpose to form a new low frequency current deep within the tissue. Flexistim IF Features Flexistim IF includes many of the features of a professional desk-top unit in a compact, portable, battery operated device. Power Supply Removeable, rechargeable Li-ion battery, with option of operation through external mains power adaptor.
3 preset and 3 adjustable programmes give a wide selection of treatment options. Memory Flexistim IF allows you to save and recall a particular programme setting and has a Usage Timer to record the time it has been used. 2.0 Contraindications, Warnings and Cautions...
Page 7
Caution should be observed when using the Flexistim IF at high strength settings. • Flexistim IF has a Yellow LED light on output socket which means Flexistim is capable of delivering outputs >10 mA (RMS) averaged over 1s. Prolonged use at high settings may cause muscle injury or tissue inflammation.
Page 8
stimulation or electrically conductive medium (gel). Patients with suspected or diagnosed heart disease should follow precautions • recommended by their physicians. Patients with suspected or diagnosed epilepsy should follow precautions • recommended by their physicians. Use caution when the patient has a tendency to bleed internally, such as following •...
Page 9
electrodes applied to the skin. Patients may experience headache and other painful sensations during or following • the application of electrical stimulation near the eyes and to the head and face. Patients should stop using the device and should consult with their physicians if they •...
Temperature & Relative Humidity of storage: -25°C–+70°C, 10%--93% R.H. • Temperature & Relative Humidity of transportation: -25°C–+70°C, 10%--93% R.H. • 3.0 IFT: What It Is and How It Works Many users will be familiar with TENS, which delivers intermittent pulses to stimulate surface nerves and block the pain signal.
Page 11
The range of this beat frequency in the Flexistim IF is 1 to 160Hz. Unlike TENS, which delivers intermittent pulses to stimulate surface nerves and block the pain signal, IFT delivers continuous stimulation deep into the affected tissue. In addition to providing pain relief by the same mechanism that TENS uses, most physiotherapists consider that IFT’s major role is to accelerate the inflammatory or...
4.0 Keypad and Display ON/OFF Frequency Programme Battery State Pause Lock Channel 1 Intensity mA Timer Channel 2 Intensity mA Warning Keys ON/OFF Key (On top of unit) This key switches the unit on or off. Press once for 2 sec and the unit is on, the LCD display located at the front of the unit will light up.
Page 13
Programme Selection Press the “Prog” key to select the programme you require (see section 8) Parameter Menu Selection Press these keys to select the following parameters one by one: Programme P1: Treatment Timer (min) FREQUENCY (Hz) Programmes P2-P4: Treatment Timer (min) Programmes P5-P6: Sweep is between High Frequency and Low Frequency over the set cycle time in seconds...
Page 14
and intensity cannot be increased. Check electrode pad position. If you are certain that the pads are positioned safely, press the SKIP key to override. The triangle will stop flashing and intensity can be increased to 60mA. Note that the two channels ADD intensity, so that max effective IF intensity is 120mA. Memory Mode Pressing the MODE button enters Memory Mode The Usage time will be accumulatively recorded when the output level is...
Page 15
Power Supply The Flexistim IF may be operated from the re-chargeable battery, or directly from the power adaptor. When the adaptor is plugged in to the Flexistim IF, the internal battery is automatically disconnected. The battery cannot be charged while in the unit, only in the charging cradle supplied.
• When the battery is low, the battery icon will flash indicating that the batteries • should be recharged. 5.0 Contents Your Flexistim IF pack should contain the following: 1 × Flexistim IF Unit • 2 × Leads • 4 × Self-Adhesive Electrodes with Connectors (Size: 50mm × 50mm) •...
6.0 How to Assemble Your Unit Your Flexistim IF has been designed to be simple and easy to use. Assembly of the Flexistim IF unit is very simple and requires only five steps. STEP 1: Battery Slide belt clip down to access battery cover.
Page 18
STEP 2: Leads If only using one lead, insert into one socket. If using two leads, insert into both sockets. A: Insert the lead wires B: Turn the plug on the lead wire 90° to lock it between the main body and handle of the unit. This prevents accidental disconnection during treatment.
STEP 5: Reading Read sections 11 to 16 and decide how to use the unit for the treatment. Note: After Use Always ensure that the unit is switched OFF before removing the electrodes. After use, return the electrodes to the clear plastic shields and seal them in the PVC bag. There is no need to separate the lead wires from the electrodes.
Page 20
it. Always switch the device off before removing electrodes from the skin. 7.2 Select a Programme Use Programme Selection Key to choose a desirable programme from P1 to P6. The output intensity resets to zero when you change a treatment program. 7.3 Set Treatment Timer The Treatment Timer defaults to 20 minutes.
Page 21
Warning: Observe caution when using Flexistim IF at high strength settings. Prolonged use at high settings may cause muscle injury or tissue inflammation. Flexistim IF is capable of delivering outputs >10 mA (RMS) averaged over 1s. Automatic keypad lock There is an automatic keypad lock if no button is used for 10 seconds. Key symbol appears.
Page 22
The interference beat frequency moves between the set HIGH and LOW frequencies over the CYCLE time set. Default is 80-130Hz in 6 seconds. 7.7 Lock and Unlock Your Own Programme To lock programme settings in Programmes 1,5 & 6, first adjust the intensity to zero, then press &...
To unlock the programme, take the same step. i.e. Press INTENSITY ▼ till it reaches zero, then press & hold the LOCK key for 3 seconds. 7.8 Memory Mode Once you set intensity >0, the Usage Timer automatically and accumulatively counts your total usage up to 999 hours 59 minutes.
45-90Hz This frequency sweep will depress the sympathetic nervous system so allowing increased activity of the parasympathetic system and increase the blood supply. See the Flexistim IF page on www.tenscare.co.uk for some published clinical protocols for IFT. 9.0 Electrode Pad Placement Warning: Ensure that intensity is zero before connecting electrodes.
Page 25
The interferential electrical signal is created by the interaction of the signals from all four pads (i.e. between the pads of each channel). So, the pads need to apply in positions so that the signals from each channel cross over the point to be treated. The two channels add and subtract to create an interference pattern.
Page 26
Elbow Knee Alternative Knee Neck Shoulder Lower Back Constipation in Children L2 L1...
Flexistim IF product page. 11.0 Care of Electrodes The electrodes that are supplied with your Flexistim IF are self-adhesive and can be used several times. Skin must be allowed to breathe, so the electrodes should be removed periodically. When not in use, the electrodes should be placed onto the clear plastic shield.
• to setting intensities at higher levels than intended. 12.0 Charging the Battery The Flexistim IF is powered by a type BL-6F rechargeable Li-ion battery. The battery cannot be charged while it is in the unit. A separate charging cradle and power adaptor are included in the kit.
Page 29
For a replacement battery, contact Tenscare or your local distributor. Use only the power adaptor and charging cradle supplied. The Flexistim IF can also be operated directly from the charger. Just plug it directly into the socket in the side of the unit. This automatically disconnects the battery.
13.0 Troubleshooting If your Flexistim IF is not working properly please check the following: Problem: No display/won’t BATTERY: turn on: i) Is it fitted? ii) Is it charged? Controls don’t i) Press Ch1 or Ch2 ▼button to unlock the keypad...
Replacement electrode pads, new batteries and lead wires are available from your supplier or distributor (see back cover for contact details), by mail order from TensCare, by telephone using a credit or debit card, or through our website. Part Number L-ST2 Replacement lead 1.25m...
If a defect appears, please make sure that the unit is being used in accordance with the instructions, if so, return it with this warranty and the proof of purchase to your nearest Flexistim IF dealer. Note: only our authorised service agents should carry out repairs of the Flexistim IF units.
17.0 Disposal of Waste Electrical and Electronic Products (WEEE) One of the provisions of the European Directive 2012 / 19 / EU is that anything electrical or electronic should not be treated as domestic waste and simply thrown away. New products are now being marked with the symbol to remind you.
Page 34
Power Supply: BL-6F Li-Ion battery 3.7V 1100mAh Mains adaptor (Class II, IEC60601-1) with charging cradle Input 100-240 V Output DC 5V 1000 mA Safety Classification: Type BF Designed for continuous use IP22 Applied Part: Self-adhesive skin electrode Environmental Operating Humidity: 15% to 93% RH Specifications: Temperature: 5°C to 40°C...
19.0 EMC Precautions Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies can affect this equipment and should be used no closer than 30 cm (12 inches) to any part of the device.
Page 36
RETURN THIS PORTION ONLY WHEN YOU RETURN YOUR PRODUCT FOR REPAIR UNDER WARRANTY. Name: Address: Postcode: Daytime telephone: E-mail: Model: Date of purchase: ATTACH PROOF OF PURCHASE DO NOT SEND IN LEADS OR ELECTRODE PADS Retailer’s name: Retailer’s address: Retailer’s postcode: Brief description of problem you are experiencing: WARRANTY IS VOID UNLESS THE ABOVE INFORMATION IS COMPLETED AND CORRECT...
Page 37
European Medical Device Regulation requires that any serious incident that has occurred in relation to this device should be reported to the manufacturer and the competent authority in your country. This can be found at: https://ec.europa.eu/docsroom/documents/36683/attachments/1/translations/ en/renditions/pdf EC Declaration of Conformity Easymed Ltd hereby declare that an examination of the production quality assurance system has been carried out following the requirements of the UK national legislation according to Annex V of the Directive 93/42/EEC on medical devices.
Need help?
Do you have a question about the Flexistim IF and is the answer not in the manual?
Questions and answers