Split Leg Positioner Instructions for Use Issue 1

1.

Introduction These instructions are intended to assist you with the use and maintenance of the split leg positioner accessory. It is important that these instructions are read thoroughly before using the equipment. The device will be adversely affected, and its life expectancy reduced, if the following instructions are not observed. We also recommend that the user familiarise themselves with the QA4 Powered Mobile Surgery System instructions for use, document no. 992010.

NOTE:

If any part of the split leg positioners are damaged or faulty, the device must be taken out of use with immediate effect and the fault reported to Anetic Aid, your authorised dealer or maintenance department. The split leg positioners must not be used until the damage or fault has been repaired.

1.1. Warnings & Cautions Various warnings and cautions are made throughout these operating instructions. A WARNING is given when the personal safety of the patient or user may be affected and when disregarding this information could result in injury. A CAUTION is given when special instructions must be followed. Disregarding this information could result in permanent damage being caused to the device.

1.2. Intended Use & Contraindications The split leg positioner accessory is intended for use within a theatre environment to aid with the positioning and abducting of patients legs during operative procedures.

1.3. Equipment Classification The equipment referenced in this document has been classified as a Class 1 Medical Device, and is both CE and UKCA marked under the scope of the Medical Devices Regulation 2017/745 and the UK Medical Devices Regulations 2002.

1.4. Putting the Split Leg Positioner into Service It is important that the split leg positioner sections are cleaned and disinfected before being put into service. Use this manual to check all the functions and refer to the ‘Cleaning and Disinfecting’ instructions.

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2.

Product Specifications

Key to Fig. 1 1. Mounting blade 2. Twist-to-release handle 3. Side bar for accessory mounting Dimensions: Product size, per section L1000mm x W420mm Mattress area, per section L650mm x W350mm Product weight, per section 7.5kg Abduction angle, per section 25° out from stretcher mid-line Adduction angle, per section 10° in from stretcher mid-line Elevation angle, per section 30° up from horizontal Articulation angle, per section 50° down from horizontal Weight Limits: Maximum patient weight limit 160kg (353lbs) Safe working load 180kg (397lbs) WARNING: Exceeding the maximum specified patient weight limit could result in failure of the split leg positioner and injury to the user. Side Bar Clamp Accessory: The split leg positioner should be used in conjunction with the following Anetic Aid side bar clamp: Item No. 10250, Clamp - Universal (Socket & Rail) - Handwheel - for UK & EU Side Bar.

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3.

Setting Up and Using the Split Leg Positioner As illustrated in fig. 3, the split legs must be abducted prior to attaching to the stretcher; this ensures they sit outside of the patients’ legs on the leg section. Each split leg is adjusted using the twist-to-release adjustment handle (fig. 1, item 2). As shown in fig. 2, insert the mounting blade (A) of the split leg into the side bar clamp (B); see fig. 1 for details of the clamp required. Note; ensure the leg section release buttons are accessible (C). WARNING: Ensure the side bar clamps are firmly tightened to prevent any movement of the leg section positioners during use. When the splits legs are securely affixed, lift the patients legs off the leg section, and onto each split leg. Next, depress the leg section release buttons (C), and remove the stretcher leg section (D); the split legs can now be positioned as required. Following the procedure, the split legs should be abducted to allow the leg section to be refitted; align the spigots of the leg section into the mating female sockets on the stretcher and push home firmly until the leg section is fully engaged. WARNING: Ensure that the leg section is fully engaged and securely locked in position.

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4.

Cleaning and Disinfecting It is recommended that only CE marked cleaning products are used in the cleaning of this device. Cleaning and Disinfection should be carried out by hand only. Clean the device with warm water and neutral detergent and dry the surfaces thoroughly using a soft cloth. Suitable disinfectants are: quaternary ammonium compounds, isopropyl alcohol & chlorine bleach up to 1% (10,000 ppm). Apply disinfectant by cloth, spray or disinfectant wipe. Following disinfection, wash off the all surfaces with clean warm water and dry thoroughly using a soft cloth. The product will be adversely affected and its life expectancy reduced if the following cautions are not observed; CAUTION: - Do not steam clean or jet wash any area of this device. - Do not soak or immerse the device. - Do not use concentrated bleaching disinfectant solutions, organic solvent or abrasive powders in the cleaning or disinfection of this product. - Dilute all disinfectants in accordance with the manufacturer’s guidelines. - Disinfectant products are corrosive in nature; failure to properly wash and dry the product surface could leave a corrosive residue which may cause damage to the product.

5.

Product Maintenance The split leg positioner does not require servicing. However, before use, visually inspect the device for any loose or damaged parts.

NOTE:

6.

If any part of the split leg positioners are damaged or faulty, the device must be taken out of use with immediate effect and the fault reported to Anetic Aid, your authorised dealer or maintenance department. The split leg positioners must not be used until the damage or fault has been repaired. CAUTION: In line with the MHRA Device Bulletin DB2006(5), maintenance work should only be conducted by suitably trained personnel following manufacturer’s guidelines.

Product Warranty The product, when new, is guaranteed to be free from defects in materials and workmanship and to perform in accordance with the manufacturer’s specification for a period of 12 months from the date of purchase from Anetic Aid Ltd or their approved Distributor. Anetic Aid Ltd will repair or replace, at their discretion, any components found to be defective or at variance with the manufacturer’s specification within this time at no cost to the purchaser. The warranty will take effect from the date of purchase, subject to the purchaser registering the product with Anetic Aid to confirm its receipt, installation date and product details. The warranty does not provide cover for breakage or failure due to tampering, misuse, neglect, accidents, modifications or shipping. The warranty is also void if the product is not used in accordance with the manufacturer’s instructions or is repaired during the warranty period by any persons other than Anetic Aid or its appointed agent. No other expressed or implied warranty is given. For details of our extended warranty packages please contact Anetic Aid or your authorised dealer.

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7.

Label Identification The following list is a description of all the labels used on the device; Label indicating maximum patient weight and the safe working load for the device.

Anetic Aid CE product label.

Anetic Aid operating print.

table screen

Do Not Sit; indicates that neither of the split leg positioner sections should be sat upon.

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Document No. 992053. Issue 1 – 22.05.23