SoftFil EasyGuide Pre-Hole Needle and Micro-Cannulas Instruction Manual
- June 5, 2024
- SoftFil
Table of Contents
Softail EasyGuide Pre-Hole Needle and Micro-Cannulas
INSTRUCTIONS OF USE
DESCRIPTION
Softail” EasyGuide is a sterile and single-use injection kit containing :
- 1 stainless steel EasyGuide pre–hole needle in its protective cap,
- 1 stainless steel blunt-tip needle (micro-cannula) graduated every centimeter along the tube in its protective cap. software cannulas are available in various lengths and gauges.
INDICATIONS
software micro-cannulas ere intended for hypodermal injection of body fluids
or tissues, or medical devices approved for human use.
CONTRAINDICATIONS
The use of micro-cannulas is contraindicated for vascular, medullar or nerve
injections.
PRECAUTIONS
This device can be used only by or on the order of a physician and/or
authorized healthcare professionals in accordance with local legislation and
also trained in injection techniques. Before use, users shall inspect the
injection site to make sure that there is no infection, inflammation, edema,
skin lesion, scar, birthmark, bony prominences or The microcannula is chosen
beset on two mein parameters which determine how flexible the micro-cannula
is:
- the length, according to the extent of the area to be treated. the outside caliber (outside diameter). indicated in gauge {G) and in millimeters (mm). to be adapted to the viscosity of the product and to the injection plane. The technique, method and products used depend on experience and are left to 1he physician and/or authorized healthcare professional’s discretion in order to ensure the best clinical results. In case of significant bleeding at the entry point, it is recommended to make a new entry point. Users should perform under appropriate aseptic conditions and handle needles with precaution to avoid inadvertent sharps injury and getting an infectious disease. Micro-cannulas are fragile devices, to hand la with caution. Any deflection, crushing or damage of the tube may lead to its breaking during its use. Avoid any sudden movement or force in case of resistance. In case of breaking during the use, the patient should be addressed as soon as possible to an authorized surgeon who will take the appropriate measures. Do not use if the product or 1he pouch appears to be damaged.
For single patient use only Contents supplied sterile
Do not reuse, reprocess, or resterilize. Reusing, reprocessing or
resterilizing may Compromise the structural integrity of the device and or
lead to device failure, which in turn may result in injury or illness.
Reusing, reprocessing or resterilizing may also create a risk of contamination
of the device and or cause infection or cross infection including, but not
limited to, the transmission of infectious disease(s). Any device which has
been used or partially used must be destroyed in accordance with the local
regulations concerning the disposal of hospital waste.
USE
- Inspect the packaging to confíirm its integrity before opening.
- Prepare the skin area to be injected: make-up removal, cleaning, rinsing, drying, antiseptic to preventa biofilm.
- Open the packaging.
- To fix the SoftFil® micro-cannula on the syringe, hold the micro-cannula by its plastic cover firmly and:
- in case of syringes with fixed female thread: screw it towards the syringe tip.
- in case of syringes with mobile female luer lock: push it strongly towards the syringe tip while twisting it clockwise. For optimal screwing, use a clamper if necessary.
- Create pre-hole at the identified entry point, with the SoftFil® EasyGuide pre-hole needle included in the sterile injection kit (Diagram A).
- Through this entry hole, insert the micro-cannula previously securely connected and locked to the syringe with one hand by sliding the micro-cannula along the SoftFil® EasyGuide pre-hole needle into the desired injection level (Diagram B). Then, remove the pre-hole needle from the hole and gently proceed with the injection (Diagram C) applying the least amount of pressure. Rely on the mark located on the hub indicating the orientation of the side port and the graduations every centimeter along the tube for determining the depth of the injection to favor a homogeneous treatment.
- To remove the SoftFil° micro-cannula from the syringe, hold the syringe and turn the mobile female luer lock counterclockwise firmly, then pull the micro-cannula backwards gently.
Dispose of off micro-cannulas and pre-hole needles in a proper sharps container.
SIDE EFFECTS
Few complications as pain, redness, bruising, hematoma, swelling or edema, may result from the injection technique itself. Furthermore, repeated injections can cause tissue scarring.
VALIDITYISTORAGE CONDITIONS
Do not use after the expiry date. The product must be stored in its original packaging, in a dry place and in the shelter of light.
SYMBOLS USED ON PACKAGING
COLOUR CODES ON HUBS AND LABELS
Black 22G/ Dark blue = 23G /Orange 25G/ Medium grey = 27GAll serious adverse events associated with use of this device should be reported to the manufacturer. All returned products must first be decontaminated, and accompanied by a decontamination certificate. If no certificate is provided, the claim will be rejected.
- SoftFil is a registered trademark of Soft Medical Aesthetics
- Soft Medical Aesthetics is EN ISO 13485-certified
- SoftFil EasyGuide, international patent pending