Mec Purair 80 User manual

Purair 80 User
Manual
MEC Medical Ltd
Unit 3 Trust Estate
Wilbury Way
Hitchin
Hertfordshire
SG4 0UZ
Telephone 01462 436396
Fax 01462 432411
E-mail: [email protected]

MEC Medical Ltd
P80UM
Issue 11
20/03/2016
Page 2 of 16
Read the Manual

MEC Medical Ltd
P80UM
Issue 11
20/03/2016
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Table of Contents
Introduction……………………………………………………………………………….……………4
Product Improvement…………………………………………………………………………....4
Responsibility of the user………………………………………………………………………..5
Responsibility of the Manufacturer ……………………………….……………….………5
General Cautions and Warnings…….……..……………………….……….………………7
Contact Information……..……………………………………………….………….……………7
Symbols Used in this Manual ……………………………………………………………….…8
Abbreviations Used in this Manual…………….……………………………………………9
Purair 80 System Overview…………………….…………………………….………………..9
Prior to User…………………………………………………………………………………………10
Installation……………………………….…………………….……………….………………..…11
System Control ……………………………………………………………….……………………13
Operations …………….……..……………………………………………….…………………….13
Purair 80 Alarm System……..……………………………………….………….……..………14
Cleaning……….............................…….…………………………….………….……………15
Maintenance……….…..……………………….……………………….………….………………16

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Issue 11
20/03/2016
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Introduction
The Purair 80 contains all the pneumatic circuitry, required to remove
anaesthetic gases from an anaesthesia system fitted with an appropriate
air break receiving unit system and dispose of them diluted with air to a
safe appropriate place of discharge.
The Purair80 machine is designed to comply with:
BS EN ISO 7396-2 2007, Medical gas pipeline systems Part 2: Anaesthetic
gas scavenging disposal systems
BS EN 60601-1-2:2015, Medical electrical equipment. General
requirements for basic safety and essential performance.
Collateral standard. Electromagnetic compatibility. Requirements
and tests
BS EN 60601-1:2006+A12:2014 Medical electrical equipment. General
requirements for basic safety and essential performance
PA80 is a registered trademark of MEC Medical Limited .
Other brand names or product names used in this manual are trademarks
or registered trademarks of their respective holders.
Product Improvement
MEC Medical Ltd. has a policy of continued product improvement and
therefore reserves the right to make changes which may affect the
information contained in the manual without giving prior notice.

MEC Medical Ltd
P80UM
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Responsibilities of the User
The Purair 80 conforms to the specifications and operating procedures
described in this manual and any accompanying notices and labels only if
it has been installed, used, and maintained in accordance with the
instructions. MEC Medical can only guarantee the safe function of the
machine if it is regularly checked and serviced at or above the standards
specified in this manual.
If you suspect that any component of the machine is worn, defective or
otherwise unfit for use, do not use the machine under any circumstances.
Replace any broken, worn or contaminated component(s) immediately.
Contact the MEC Medical distributor from whom the machine was
obtained for further service.
Responsibilities of the Manufacturer
The manufacturer accepts responsibility for the effects on safety,
reliability, and performance of the equipment only if assembly
operations, extensions, adjustments, modifications, and repairs are
carried out by persons with written authorization from the manufacturer,
and the equipment is used in accordance with the instructions for use
and the electrical installation of the relevant room complies with the
‘Regulations for the Electrical Equipment of Buildings’.
If during the warranty period the equipment is serviced by an
unauthorized party, the warranty will be void.

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Note to Service Personnel
The Purair80 must only be serviced by Qualified Service Personnel.
The contents of this manual are not binding. If any significant difference
is found between the product and this manual please contact MEC
Medical Ltd. for further information.
To ensure correct functioning, the equipment must be serviced at regular
intervals.
MEC Medical Ltd. recommends that the machine should be serviced at
intervals not exceeding one year. Qualified Service Personnel and
genuine spare parts should be used for all servicing and repairs. MEC
Medical Ltd. will not otherwise assume responsibility for the materials
used, the work performed or any possible consequences of the same.
In communication with MEC Medical Ltd., quote the model and serial
number of the equipment, with the approximate date of purchase. If the
unit is being returned for repair, indicate the nature of the fault or the
work you require to be carried out.

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P80UM
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20/03/2016
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General Cautions and Warnings
Table 1 :-
The user must be familiar with the machine and its various functions before
using it on a patient.
Federal law restricts this device for sale by or on the order of a physician.
Incorrect use of the equipment described herein may result in injury to the
patient. Read this manual before operating the machine. You must be familiar
with the machine and its functions before using it on a patient.
Keep this manual with the system to refer to and to answer any questions
that arise about the system’s operation, maintenance or, if necessary, repair.
The Purair 80 is latex free, note that any replacement parts must not use
latex.
Warning HAZARDS can result from unauthorized modification of this ME
EQUIPMENT
WARNING: To avoid the risk of electric shock, this equipment must only be
connected to supply mains with protective earth.
Warning: A potential for electromagnetic or other interference
between this EQUIPMENT and other devices
This MEC Equipment is rated to over voltage category I according to
IEC 60664-1
Contact Information
MEC Medical Ltd
Unit 3 Trust Estate
Wilbury Way
Hitchin
Hertfordshire
SG4 0UZ
Tel +44 (0) 1462 436396
E-Mail: sales@mecmedical.com

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Table 2 - Symbols replace words on the equipment, on the Equipment Labels or in this manual.
Symbols Used in this Manual
CAUTION: There is a potential hazard to
the equipment
Exhaust
IEC symbol for denoting type B applied
part
Latex free material is used
WARNING: There is danger of personal
injury to the user or patient
Dangerous voltage
Further relevant or helpful information
No AC power supply
Turning the control in the direction of
the thickening line causes an increase in
that parameter
Internal power supply
Power off
Under voltage power supply
Power on
Fuse
IEC symbol for alternating current
Read from the top of the bobbin
Pipeline gas supply
Gas inlet
Cylinder gas supply
Gas outlet
Anaesthesia breathing system
This denotes that the waste of electrical
and electronic equipment must not be
disposed as unsorted municipal waste and
must be collected separately. Please
contact an authorized representative of
the manufacturer for information
concerning the decommissioning of your
equipment.
1200
900
600
300
1500

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Table 3
Abbreviations Used in this Manual
The Purair 80 System Overview
The Purair 80 Active Gas Scavenging System
In large hospitals the AGSS system is powered by a central plant that has outlets at all
places in the building that anaesthesia systems are used.
In a number of smaller establishments and isolated places in general hospitals no such
outlet exists.
The use of the MEC Purair 80 is to provide the same facility and is installed in the room
where that anaesthesia system is to be used and the exhaust taken to a safe outside
disposal location.
Simplistically the PA80 system can be broken down into three component areas:
Plant (main fan)
Exhaust pipe work plumbed to the rear of the unit
Terminal outlet is provided on the front panel
The purpose of the system is to provide the extraction flow rates to remove waste
anaesthetic gases from the receiving unit reservoir. The role of the receiving unit is to
provide a safe interface between the patient and the extraction flow rates.
Standard / Measurement
ISO 7396-2 (2007)
Extraction Flow Rate
75 - 130 L/min
The extraction flow rate ensures that waste anaesthetic gases are adequately removed
from the system. The importance of this flow rate is that if it falls too low it may not be
sufficient for waste gas removal. This would lead to the waste gases spilling out from the
base of the receiving unit reservoir into the immediate working environment; if too high it
may lead to an increase of the induced flow at the patient connection port.
The PA80 is fitted with a Fan Failure warning device. Should the fan fail during use an
alarm will sound for at least 10 seconds regardless of the mains supply being the cause of
failure. If the supply is still available a red LED will be illuminated on the front panel.
The MANUFACTURER MEC Medical will make circuit diagrams available on request.
ESD
Electrostatic Discharge
hPa
Gauge pressure expressed in hecto Pascal
kPa
Gauge pressure expressed in Kilo Pascal’s
PSI
Gauge pressure expressed in Pounds per Square
inch
Bar
A Pressure of 1 Atmosphere or 100 kPa or 14.5 PSI

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Prior to Use
Remove the unit carefully from the packaging
Carefully place the unit upside down on a clean flat surface
* Remove the 4 x Transit bolts indicated by the red arrows on the
bottom of the unit.
Use the supplied spanner in order to do so.
Remove red arrow labels
Gently rotate the unit upright
Remove warning label from the top of the unit.
*It is recommended that the transit bolts and spanner are retained for any
potential transportation needs.

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Installation
Table 4 - Fixed Installation Bill of Material for the Purair 80 Scavenging System
Product Description
Part Number
Quantity
Push fit Waste Pipe 32mm x 2m White
113833
12 meters
Purair 80 Pipe Fixing Kit
131812
1
Exit Kit
131811
1
A typical installation should follow diagram 1 on page 12 using
the material shown in table 4above.
Ensure that when installed the air vents on the case are free from
obstruction and free movement of air is provided.
The pipe work should be installed with clips to the wall with
approximately 600mm between them
The pipe work should pass through the outer wall and turn downwards
and the outlet vent attached as shown in diagram 1 the vent outlet
should be at least 3 meters above the outside ground.
Connect the IEC power lead in to the back of the unit
Connect the elbow end on the flexible tubing to the exhaust port
on the back of the unit. Ensure the elbow is fully pushed on to
the unit
Once the flexible tube is connected, place the unit in its intended
place of use
Install exit pipe work from the open end of the flexible tube to
the required exit point
When installing this equipment position it such that the Electrical
supply can be turned off and the plug disconnected
The unit is not to be floor mounted and is to be sheltered from
liquid splashing in a cupboard or similar location.

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P80UM
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Diagram 1 –Installation
This is a typical installation and may be varied to suit the local
environment.

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System Controls
Power Indicator
Power On/Off Switch
AGSS Inlet Port
Pump Status
Indicator
Exhaust Port
Connect to an
to an external
vent
Mains
Power
Connector
To release IEC plug from the socket. Slide the red button on the
plug towards the cable and remove the plug from the unit.
Inlet
Port
Mains
Power
Conne
ctor

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Operations
Plug in the power lead from the unit to the mains
The power indicator will illuminate
Switch on the unit
Suction will be initiated at the suction port
Pump occlusion indicator will be illuminated green
Switch off the unit
Connect your device to the inlet port
To use the complete system switch the unit on
When not in use switch the unit off.
The audible alarm will sound for more than 8 seconds which is
normal
When the use of the system is over please Switch off on the front
panel”
Alarm System
The alarm system uses a Bi colour LED and audible alarm signal to indicate
the various states of the system an alarm signal will sound in any failure
mode:
Table 5 -
LED Colour Code
Status
Audible Alarm Signal
Green
Running Normally
Amber
Inlet Occlusion
Alarm triggered
Red
Fan Failure
Alarm triggered
When the unit is switched off or disconnected from the mains the alarm
will sound for more than 8 seconds.

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Specifications
Electrical
Table 6 -
Voltage
230V 50Hz
Operating Current
0.4 amps
Power
100VA
Fuse rating
2 Amps in Plug
The ON/OFF switch is a circuit breaker set to 3 amps
The system is for use in an environment <25oc & 90% RH
Dimensions and weight
Table 7 -
Length
325 mm
Width
250 mm
Height
240 mm
Weight
<10Kg
Flow at Inlet
80 LPM
Cleaning
The PA80 is not a sterile system but require periodic cleaning of all outer
surfaces with commonly used disinfectants, cleaning agents and
methods.
Do not use caustic substances such as trichloroethylene for cleaning
as it may damage the surfaces.
The components and materials of the PA80 are not compatible with
autoclaving and Ethylene Oxide sterilization processes.
When cleaning surfaces do not allow water ingress into the cabinet, it
could damage the electrical components and cause a fire risk

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P80UM
Issue 11
20/03/2016
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Maintenance
Scheduled
Electrical safety checks should be performed at least every 12 months by
trained service representative.
The Filter inside the motor housing should be changed annually.
Examination and Cleaning of the exhaust piping and the outside vent and
insect guard should be performed at least every 12 months by a trained
service representative.
Inspect all labels for legibility and adhesion least every 12 months by a
trained service representative.
For help in maintaining the equipment please contact MEC Medical Ltd
see page 5 and a trained service representative will be allocated.
Training of hospital service staff can be provided by MEC Medical Ltd.
Isolate from electrical supply before removal of the cover by
disconnecting the plug.
Parts used in service or repair must be recognised MEC parts to avoid
any potential system malfunction.
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