Instructions for Use
4 Pages
Preview
Page 1
1.
Introduction This Guide refers to the following products. Six-use Day Tourniquet Cuff: 40285 Paediatric – 305mm / 12” 40288 Arm – Narrow - 460mm / 18” 40290 Arm – 460mm / 18” 40292 Large Arm / Small Leg – Narrow - 610mm / 24” 40293 Large Arm / Small Leg – 610mm / 24” 40295 Leg – 860mm / 34” 40296 Large Leg – 1070mm / 42” 40297 Leg – Conical - 860mm / 34” 40298 Large Leg – Conical – 1070mm / 42 Reusable Tourniquet Cuff: 40200 Paediatric – 305mm / 12” 40210 Paediatric – IVRA / Bier’s Block - 305mm / 12” 40220 Arm – 460mm / 18” 40225 Arm – Narrow - 460mm / 18” 40230 Arm – IVRA / Bier’s Block - 460mm / 18” 40240 Large Arm / Small Leg – 610mm / 24” 40245 Large Arm / Small Leg – Narrow - 610mm / 24” 40250 Large Arm / Small Leg – IVRA / Bier’s Block - 610mm / 24” 40260 Leg – 860mm / 34” 40268 Leg – Conical - 860mm / 34” 40270 Large Leg – 1070mm / 42” 40278 Large Leg – Conical – 1070mm / 42” These products are manufactured by Anetic Aid Ltd. They are CE marked against the requirements of the Medical Device Regulation 2017/745, and are classified as a Class 1 medical device. Anetic Aid Ltd. 44 New Lane Havant, Hampshire, PO9 2NF
Our representatives are available for on-site consultation or training on any of these products and our head office team will be pleased to answer any queries you may have.
2.
Product Details Anetic Aid Tourniquet Equipment is highly acclaimed for its reliability and user friendly designs. Widely used across the UK, these devices will be found ideal for Theatre, A&E and Pain Relief Clinics. The devices intended purpose is as a method of creating a bloodless field for surgical procedures, or limiting an area of anaesthesia during Intravenous Regional Anaesthesia, when used in conjunction with a tourniquet inflation device. Life expectancy of these products is dependent on the level of care and maintenance. Tourniquet cuffs are guaranteed against defects found in material or workmanship for a period of 6 months from date of purchase. The device should be inspected, cleaned and disinfected prior to first use. The device is latex free and not supplied sterile.
Document No. 992046. Issue 2 – 18.08.22
3.
Contraindications Contraindications are the final decision of the attending clinician, those to be taken into consideration with the intended patient are;
Infection at the site of application. Hypertension. Circulatory disorder. Diabetes. Compound fracture. Existing crushing injuries. Recent orthopaedic reconstructive surgery. Concomitant excess swelling. Existing skin condition. Recent skin graft. Sickle cell disease.
4. Instructions for Use 4.1. General Products should be used for their intended purpose by suitably trained personnel. Familiarize use of product on an appropriate volunteer prior to introducing to clinical use. Before use, inspect the product for any signs of deterioration, damage or component failure. O-Rings: Check O-rings prior to each use of machine, and replace O-Rings if there are any signs of wear. Replace O-rings at least monthly as part of regular maintenance routines.
4.2. Applying a Tourniquet Cuff Ensure the correct size of tourniquet has been selected for the limb being applied to; it should overlap by at least a third of its length. Apply padding/cuff cover according to site policy. Apply the cuff over any padding/cover orientated so the tourniquet inflation device connection hose is directed away from the surgical site. The applied cuff should be sited at maximum distance from the surgical site and at the maximum circumference of the limb, where the peripheral nerves are well protected by soft tissue. The uninflated cuff should not be tight or loose; two fingers should fit between any padding/cuff and limb. Ensure the padding and cuff has a suitable barrier to prevent under-tourniquet preparation solution burns. The cuff can now be inflated according to the prerogative of the surgeon.
5. Care & Maintenance 5.1. Storage Store in a cool dry place away from radiators and other heat sources. Store covered and away from direct sunlight or ultra violet lighting systems.
5.2. Inspection
The product should be visually inspected on a daily basis to check for leaks and assess the integrity of all seals. CAUTION: Do not attempt to repair tears or splits with self-adhesive tapes.
Document No. 992046. Issue 2 – 18.08.22
5.3. Cleaning (by hand)
Products should be wiped over after each use thoroughly with warm water and neutral detergent or an appropriate disinfectant wipe. Wipe thoroughly removing any surface residue and allow to dry at room temperature. Clean all touch fastener attachments periodically with a soft brush removing any velband. Where applicable, mark the label indicator as one use against the appropriate circle
5.4. Disinfection (by hand) Products should be wiped over thoroughly with warm water and disinfectant or an appropriate disinfectant wipe. Suitable materials are diluted chlorine solution or alcohol based materials following manufacturer’s guidelines. Note: A 1% solution of sodium hypochlorite is an acceptable option for these products. Wipe over thoroughly removing any surface residue and allow to dry at room temperature. CAUTIONS: The following materials should not be used in cleaning as they will adversely affect these products and may reduce their life expectancy; Strong bleaching disinfectant solutions. Organic solvents (i.e. spirits). Abrasive powders or materials. These products should not be autoclaved. Products will be damaged and their life expectancy reduced if exposed to excessive heat, or pressed hard against sharp objects. Devices found heavily soiled or, where applicable, showing six uses against the label indicator, should be discarded.
Document No. 992046. Issue 2 – 18.08.22