Anetic Aid 21380 User manual

Document No. 992054. Issue 1 –07.02.24

Document No. 992054. Issue 1 –07.02.24 Page 1
1. Introduction
These instructions are intended to assist you with the use and maintenance of the
Gardiner hand surgery system 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.
Storage; to maintain the product in its best condition, store in a cool dry place away
from radiators and other heat sources, and store away from direct sunlight or ultra
violet lighting systems.
NOTE:
If any part of the Gardiner hand surgery system is 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
Gardiner hand surgery system 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 Gardiner hand surgery system is intended for use within a clinical environment to
provide a platform on which a patients hand is supported and positioned for operative
procedures, including but not limited to the following; carpal tunnel decompression,
trigger finger release, flexor tendon repair, extensor tendon repair, tenolysis, fracture
fixation, steroid injection, trapeziectomy, de Quervain’s release, nail bed trauma, digital
nerve repair, excision of skin lesion.
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 Gardiner Hand Surgery System into Service
It is important that the Gardiner hand surgery system is 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
1.
Hand table
2.
Surgery screen mounting stem
3.
Surgery screen flexible arm
4.
Surgery patient screen
Hand table weight limit:
Safe working load
25kg (55lbs)
WARNING: Exceeding the safe working load could result in failure of the
Gardiner hand table and injury to the user.

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3. Setting Up and Using the Gardiner Hand Surgery System
3.1. As illustrated below, seat the patient on the theatre table and adjust the backrest and
head section to the desired angle.
3.2. Mount the hand table onto the side bar in a rotary clamp so the clamp is
(approximately) vertically aligned with the patients shoulder and lock the clamp. Adjust
the height of the hand table to suit the patient, and tighten the clamp to lock the hand
table in position.

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3.3. Mount the surgery patient screen in a rotary clamp onto the side bar above the hand
table and lock in position. The height and position of the screen can be adjusted by
raising or lowering the surgery screen mounting stem or by manipulating the surgery
screen flexible arm.
3.4. The final step is to prepare the patient’s arm for surgery and drape the non-surgical
area.

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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 Gardiner hand surgery system does not require servicing. However, before use,
visually inspect the device for any loose or damaged parts.
NOTE:
If any part of the Gardiner hand surgery system is 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
Gardiner hand surgery system 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.
6. 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 safe working load of
25kg (55lbs) for the device.
Anetic Aid CE product label.
Anetic Aid mattress screen print.

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