MDM/992043/10/120121
Page 2
2. Summary of Warnings, Cautions and Side Effects
In common with all medical devices of this nature there are inherent risks and side-effects
that the user should be made aware of. Whilst every effort has been taken to eliminate
these risks, care should be taken when using the tourniquet. It is important that the user
familiarises themselves with all of the warnings and cautions contained within this
document.
WARNINGS:
The pressure and duration of application of a tourniquet cuff is a matter
for clinical judgement. Application of a tourniquet cuff for excessive
duration or at excessive pressures can result in tissue necrosis. The correct
size and shape of cuff will allow cessation of blood flow at lower pressures
and reduce the risk of tissue necrosis.
Intra Venous Regional Anaesthesia (IVRA) should only be administered by
staff that have been trained and approved to carry out this procedure.
The castors are intended for positioning the tourniquet within the
operating room; they are not to be used for transportation over thresholds
or steps.
The AT4 should always be moved by pulling the handle; it should not be
moved by pushing.
When the electrically powered AT4 is not in use it should be connected to
the mains electrical supply to recharge the battery; see Section 10.
It is recommended that only CE marked cleaning products are used in the
cleaning of the AT4; see Section 9.
Dilute all disinfectants in accordance with the manufacturer’s guidelines;
see Section 9.
CAUTIONS:
Before use, ensure all device functions operate correctly. Also visually
inspect the device for any loose or damaged parts. If the devices
performance changes from that specified or required the device should be
taken out of service immediately.
Maintenance work should only be conducted by suitably trained personnel
following manufacturer’s guidelines.
Do not use concentrated solutions of bleach or disinfectant, organic
solvents, abrasive powders or expose any part of the tourniquet to
excessive heat. For cleaning and disinfection methods; see Section 9.
Disinfectant products are corrosive in nature; failure to properly wash and
dry the surfaces could leave a corrosive residue which may cause damage.
Do not steam clean or jet wash any areas of the device or its detachable
hoses or cables.
Do not use concentrated bleaching disinfectant solutions, organic solvents,
abrasive powders or expose any part of the device to excessive heat.
SIDE EFFECTS:
Application of a tourniquet cuff for excessive duration or at excessive
pressures can result in tissue necrosis. The correct size and shape of cuff will
allow cessation of blood flow at lower pressures and reduce the risk of
tissue necrosis.
Intra Venous Regional Anaesthesia (IVRA) if incorrectly performed can have
catastrophic and even fatal side effects. The inclusion of a system to reduce
the risk of errors should not be seen as mitigating or reducing the level of
training and caution required when using IVRA. IVRA should only be
administered by staff that have been trained and approved to carry out this
procedure.
To Next Page
