Anetic Aid AT4 User manual

© Anetic Aid Ltd. All rights reserved; this document is not to be reproduced in whole or in part without the permission
of the copyright owners. The company reserves the right to modify or improve the equipment referred to.
MDM/992043/10/120121
Contents Page
1. Introduction . . . . . . . . 1
1.1. Warnings & Cautions . . . . . . 1
1.2. Intended User . . . . . . . 1
1.3. Equipment Classification . . . . . . 1
1.4. Associated Devices . . . . . . . 1
1.5. Serial Number Label . . . . . . 1
2. Summary of Warnings, Cautions and Side-effects . . . 2
3. Symbols . . . . . . . . . 3
4. Getting Started . . . . . . . . 5
4.1. Fitting the Fuse, and Charging the Battery . . . 5
4.2. Connecting, and Storing, the Cuff Hoses . . . . 5
5. Product Functions . . . . . . . 6
6. Controls and Operation . . . . . . . 7
6.1. Preparation . . . . . . . 7
6.2. General Operation . . . . . . . 8
6.3. IVRA Operation . . . . . . . 9
6.4. Alarms and Warning Indicators . . . . . 10
7. Handling. . . . . . . . . 11
8. Performance and Technical Specification . . . . 11
9. Cleaning and Disinfecting . . . . . . 12
10. Installation of Battery . . . . . . . 13
11. Expected Battery Life . . . . . . . 14
12. Maintenance . . . . . . . . 14
12.1. Daily . . . . . . . . 14
12.2. Recurrent (Periodic) Testing . . . . . 14
13. Product Warranty . . . . . . . 14
14. Disposal of Waste Electrical & Electronic Equipment (WEEE) . . 15

MDM/992043/10/120121
Page 1
1. Introduction
These instructions are intended to assist you with the operation of the AT4 Tourniquet
and it is important that the instructions are read thoroughly and understood before using
the equipment.
It is also important to check the tourniquet before use to ensure there is no loss or change
in performance; ensure that all functions operate correctly and to their full range. We
recommend that the tourniquet is visually inspected for any damaged parts, or
contamination before use.
1.1. Warnings & Cautions
The European Medical Device Directive requires all manufacturers to include appropriate
warnings and cautions and many of the warnings and cautions will apply to other similar
devices.
To ensure that all users are well informed 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
trolley.
This product is intended for the control of pneumatic tourniquet cuffs in operating
theatres or similar environments.
1.2. Intended user
Tourniquets should only be operated by trained and competent clinical staff and used in
accordance with your establishments approved clinical practice.
WARNING: Intra Venous Regional Anaesthesia (IVRA) should only be
administered by staff that have been trained and approved to carry out this
procedure.
1.3. Equipment Classification
This tourniquet has been classified as a ‘Class IIa’ medical device in accordance with the
European Medical Device Directive 93/42EEC as amended by 2007/47.
1.4. Associated Devices
The cuffs which may be used with this device are considered to be associated devices and
will have their own instructions for use which should be read and understood. Any
conflicts between the instructions should be resolved before use.
To ensure compatibility it is recommended that accessories and associated devices are
supplied by Anetic Aid. Inappropriate bore size of the hose and compliance of the cuff
can affect the stability of the pressure control.
Ensure that O rings on cuffs and associated hoses are in good condition before use.
1.5. Serial Number Label
The Serial and Reference Numbers are located on a label on the rear of the device. When
requesting service ensure that both the Ref No and the Serial No are quoted.

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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.

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3. Symbols
The following symbols have been used on the AT4 tourniquet control panel;
Symbol:
Title:
Description:
ON / OFF
Press to turn ON, Green indicator.
To turn OFF press and hold until pressure
displays are blank.
AUDIBLE ALARM PAUSE
Press once to pause audible alarms for 3
minutes; Amber Indicator (except Low
Battery).
AUDIBLE ALARM OFF
Press second time to cancel audible alarms
(except Low Battery).
Red Flashing Indicator.
INFLATE
PRESSURE CONTROL
Turn to set inflation pressure blue channel.
Turn to set inflation pressure red channel.
PRESSURE SET OR APPLIED
Indicates the set and applied pressures.
INFLATE
Inflates blue and red channels respectively.
DEFLATE
Deflates blue and red channels respectively.
IVRA
Selects IVRA control mode interlocking the
controls of both channels. Amber indicates
ready but not operational, green indicates
operational, Red indicates incorrect action.
TIMER REMINDER
Prior to inflation of cuff this button sets the
reminder start time and repeater frequency.
This function is cancelled after the cuff has
been inflated. Audible Reminder is supported
by amber visual indicator and flashing of the
timer LCD and is cancelled by pressing the
timer button.
TIME
Indicates the timer display for blue and red
channels respectively.
BATTERY LEVEL
Green: represents acceptable battery level
Amber: connect to mains as soon as soon as
practical.
Green/Amber: Charging.
Red: connect to mains immediately.
MAINTENANCE INDICATOR
Amber: Service required.
Red: Stop using and request immediate service.
The following symbols are used on the AT4 tourniquet;
Symbol:
Title:
Description:
CE MARK
Indicates compliance with the European
Medical Device Directive 93/42 and
amendments thereto. Symbol is associated
with a number indicating the Notified Body.
READ INSTRUCTIONS
Read Instructions For Use.
CAUTION
Indicates the need for the user to consult the
instructions for use for important cautionary
information.

MDM/992043/10/120121
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FUSE
Location and value of fuses.
BATTERY
Location and type of battery used.
WEEE
Do NOT dispose of in domestic waste see
Section 14.
V
SUPPLY VOLTAGE
Supply voltage of mains inlet.
~ Hz
SUPPLY FREQUENCY
Frequency of AC mains supply.
W Max
MAX POWER
CONSUMPTION
Maximum power consumption in watts.
SN
SERIAL NUMBER
Unique serial number used for traceability.
REF
REFERENCE NUMBER
Reference or model number indicating the
type of unit.
DATE OF MANUFACTURE
MANUFACTURER
Date of manufacture as YYYY:MM
Name and address of manufacturer is
adjacent.
Do Not Push
The AT4 should not be pushed as it is more
stable when pulled by the handle.
Rx ONLY
CAUTION: Within the USA Federal law restricts
this device to sale by or on the order of a
physician.

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4. Getting Started
Packaging can be fully recycled, or reused.
During manufacture the base moulding and front panel are protected by a
thin plastic film. The film, indicated with the symbol illustrated, should be
removed during commissioning.
On receipt, or after periods of storage, the AT4 must be cleaned and disinfected before
being put into clinical use.
4.1. Fitting the Fuse and Charging the Battery
For safety, the AT4 is shipped without the batteries being operational; the fuse is removed
during final inspection. The unit will have been supplied with a T3.15A fuse in a clear
plastic bag with the operating instructions; this needs to be fitted during commissioning.
Lay the AT4 on its back, and fit the fuse in the fuse holder indicated by the fuse symbol
on the underside of the AT4.
On receipt, or after periods of storage, the AT4 must be connected to the mains electricity
supply with the cable provided for 24 hours to allow the battery to be charged.
When fully charged the AT4 may be disconnected from the mains, and operated from the
battery, avoiding the requirements for mains cable in the surgical area. The AT4 may also
be operated while connected to the mains if the battery is low.
When not in use it is recommended that the AT4 be left connected to the mains to ensure
that the battery is fully charged and ready for use.
4.2. Connecting, and Storing, the Cuff Hoses
The AT4 will have been supplied with Red and Blue cuff hoses. These should be connected
to the connections on the front of the AT4 and below the appropriate red or blue
segment of the front panel. There are two connections to pressurise the cuff, and two
connections which are for stowage of the cuff end of the hose when not in use.

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5. Product Functions
1.
Control Panel
2.
Cuff Supply Hose Storage Connectors
3.
Cuff Supply Hose Connectors
4.
Cuff Supply Hose
5.
Pulling Handle
6.
Cuff Hooks
7.
Storage Facility
8.
Additional Storage Facility Locating Pins
9.
IEC Socket

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Page 7
6. Product Controls and Operation
1.
ON/OFF
2.
Set Pressure display
3.
IVRA (Intravenous Regional Anaesthesia)
4.
Applied Pressure display
5.
Elapsed Time H:MM
6.
Reminder control
7.
Audible Alarm, pause and indicator
8.
Maintenance indicator
9.
Battery Level indicator
10.
Pressure controller
11.
Deflate button
12.
Inflate button
6.1. Preparation
Ensure that the battery has been charged and the battery indicator is green; if not it must
be used connected to the mains supply.
The red and blue cuff hoses should be connected to the connectors in the front of the
AT4 ready for use below the appropriate red or blue segment of the front panel. There
are two connections to pressurise the cuff and two which are for stowage of the cuff end
of the hose when not in use.
Select the appropriate size and type of cuff(s) and apply to the patient’s limb(s). The
correct size and shape of cuff will allow cessation of blood flow at lower pressures and
reduce the risk of tissue necrosis.