A100 Absorber Ecoflow System User Manual
A100 Absorber Ecoflow System User Manual
A100 Absorber Ecoflow System User Manual
(i)
FOREWORD
(ii)
CONTENTS
Page No.
USER RESPONSIBILITY 1
2. PURPOSE 4
3. DESCRIPTION
3.1 Canisters 6
3.2 Inspiratory and Expiratory Non-return Valves (NRV) 6
3.3 Adjustable Pressure Limiting (APL) Valve 7
3.4 Bag/Ventilator Switch (optional) 7
3.5 Fresh Gas Inlet and Supply Tubing 8
3.6 Manometer 8
3.7 Bypass System (optional) 8
3.8 End Tidal Carbon Dioxide Monitoring 8
3.9 Gas Flow Schematic 9
4. SPECIFICATION
4.1 General Dimensions and Weight 10
4.2 Resistance of Breathing System 10
4.2.1 Expiratory Resistance 10
4.2.2 Inspiratory Resistance 10
4.3 Internal Compressible Volume 11
4.4 System Leakage Rate 11
4.5 Canister Capacity and Resistance 11
4.5.1 Canister Capacity 11
4.5.2 Canister Resistance 11
4.6 Non-return valves 12
4.7 Mode of Operation 12
4.8 Device Classification and Labelling 12
4.10 Environmental 12
(iii)
CONTENTS
Page No.
6. PRE-USE CHECKS
6.1 Pre-use Checklist 17
6.2 Leak Test 17
6.3 APL Valve Test and Pressure Relief Valve Test 17
6.4 Non-return Valve Test 18
6.5 Bag/Ventilator Switch Test 18
6.6 On/Off Switch (if fitted) 18
7. USER MAINTENANCE
7.1 Maintenance and Service Policy 19
7.2 Canisters and Seals 19
7.3 Condensate Drainage 19
7.4 Non-return Valves 20
7.5 Manometer 20
7.6 APL Valve 20
7.7 Spirometer System Sample Tubing 20
8. STERILISATION
8.1 Bacterial Filters 21
8.2 Sterilisation Policy 21
8.3 Patient Circuit Components 21
8.4 Absorber Assembly 22
8.5 Refit after Sterilisation 22
8.6 Sterilisation and Disinfectant Treatment Table 23
9. ORDERING INFORMATION 24
(iv)
USER RESPONSIBILITY
This device has been built to conform with Statements in this manual preceded by the
the specification and operating procedures stated following words are of special significance:-
in this manual and/or accompanying labels and
notices when checked, assembled, operated,
maintained and serviced in accordance with these
instructions. WARNING means there is a
To ensure the safety of this device it must be possibility of injury to
checked and serviced to at least the minimum yourself or others.
standards laid out in this manual. A defective, or
suspected defective, product must not under any
CAUTION means there is a possibility of
circumstances be used.
damage to the apparatus or
other property
The user must accept responsibility for any
malfunction which results from non-compliance
NOTE indicates points of particular
with the servicing requirements detailed in this
interest for more efficient and
manual.
convenient operation.
Additionally, the user must accept responsibility
for any malfunction which may result from misuse
of any kind, or non-compliance with other The reader must take particular notice of the
requirements detailed in this manual. warnings, cautions and notes provided throughout
this manual
Worn, broken, distorted, contaminated or missing
components must be replaced immediately.
Should such a repair become necessary it is
recommended that a request for service advice
be made to the nearest Penlon Service Centre.
1
1. WARNINGS AND CAUTIONS
The following WARNINGS and CAUTIONS must 8. Underfilling of canisters can lead to
be read and understood before using this inefficient CO2 absorption.
Anaesthetic Apparatus Overfilling may result in poor sealing of
canisters due to caking of granules and
WARNINGS abrasion of seals and canisters. See 3.1
and 5.3.
General Information
9. Do not use the Penlon A100 Absorber
1. Personnel must make themselves
without ensuring that it passes all
familiar with the contents of this
pre-use checks. See Section 6.
manual and the function of the A100
Absorber before use. 10. After servicing and cleaning
procedures, verify positive action of the
2. Trichloroethylene must not be used in
bag/ventilator selector switch before
association with soda lime.
the unit is used clinically.
Check that at all times the actuator
3. This unit is restricted to use with non-
shaft on the switch is free to move from
flammable anaesthetic agents only.
one end of its travel to the other.
4. The A100 Circle System Absorber must
only be used when securely mounted in
Using the absorber
an upright position.
11. Bag/ventilator switch:
a) The inspiratory and expiratory non-
If no ventilator is connected to the
return valves (NRV) are gravity
absorber, care must be taken to ensure
operated.
that the bag/ventilator switch is kept in
b) Spillage of absorbent may
the ‘Bag’ position, to avoid loss of gas
contaminate the breathing system.
from the breathing system and to
See 3.2/5.1
maintain the reservoir bag in the
Before using the absorber system. However, when no ventilator is
connected, the ventilator port must be
5. The use of patient Y-pieces containing left uncapped. See 3.4
non-return valves in
connection with the Penlon Circle 12. Condensation, which may collect in the
System Absorber is hazardous, bottom of the absorber is caustic and
because two sets of non-return valves care must be taken not to spill it on the
may easily be connected in skin when draining the trap provided.
opposition, by error. After draining ensure that the drain
valve is fully closed.
6. Breathing hoses and bags used with See section 7.3.
the apparatus must comply to ISO 5367
(Hoses) and ISO 5362 (Breathing Bags)
respectively. 13. Kinking of the fresh gas tube is a
The resistanceand compliance of these known cause of anaesthetic accident
hoses and bags provide essential and the use of unsuitable tubing can
factors for the satisfactory use of this contribute to this situation. See 3.5.
system.
14. Any breathing system utilising the
A100 absorber must be fitted with:
7. Do not connect any vacuum system
directly to the APL valve. A receiving a) An oxygen monitor complying with
system with positive and negative ISO 7767.
pressure control functions must be b) A minute volume monitor.
interposed.
c) A breathing system integrity alarm.
Systems must comply with ISO 8835
Part 2. See 5.2.3.
2
WARNINGS AND CAUTIONS
CAUTIONS
3
2. PURPOSE
4
1
13 14 15
2
3
12
4
11
10
5
3. DESCRIPTION
3.1 Canisters
Further Information
Mounting the absorber – section 5.1
Refilling the absorbent – section 5.3
Pre-use check – section 6
Cleaning – section 7.2
Draining condensate – section 7.3
Sterilisation and autoclaving – section 8
Gas Flow
a) Gas flow is upward through the
canisters so that the lower unit will be
exhausted first.
b) The upper and lower canisters are
interchangeable.
6
DESCRIPTION
7
DESCRIPTION
8
DESCRIPTION
Component layout
In all models the gas flow through the canisters is
from bottom to top.
Note that the bag/ventilator connection is between
the absorber and the patient. Bag squeezing or
the use of mechanical ventilation does not result in
the transport of dust toward the patient, but tends
to drive dust back into the absorber.
A B
Key
1. Patient
2. Manometer (optional)
3. Expiratory NRV (non-return valve)
4. APL (adjustable pressure limiting) valve
5. Absorber canister
6. Fresh gas inlet
7. Bag/ventilator control / mechanical link
8. Breathing bag
9. Ventilator
10. Inspiratory NRV (Non-return valve)
11. On/Off (bypass) control / mechanical link
9
4. SPECIFICATION
Both canisters filled to the MAX level with fresh absorbent, and the APL
valve fully open.
Bacterial Filter:
Bacterial filters may be used in this breathing system provided they do
not raise the resistance values of the whole system to above 0.6 kPa
(6 cmH2O).
Bacterial Filter:
Bacterial filters may be used in this breathing system provided they do
not raise the resistance values of the whole system to above 0.6 kPa
(6 cmH2O).
10
SPECIFICATION
Note that the reservoir bag is not fitted and the bag mount is blocked.
The patient connection port is sealed and the APL valve fully closed.
Recommended absorbent:
Soda lime or barium lime, with a colour indicator, 4-8 mesh, supplied in
bulk.
Alternatively, pre-packs may be used.
Note
i) The absorber canisters are not electrically conductive.
ii) Cleaning and sterilisation details are given in section 7.
11
SPECIFICATION
60 Flow
4.6 Non-return Valves (L/min)
Pressure drop across the inspiratory and 50
expiratory non-return valves at an air flow of
60 L/min: 0.1 kPa (1 cmH2O).
40
Labelling
This symbol denotes: Refer to the User Manual
4.10 Environmental
Operating:
Temperature 15 to 30oC (59 to 86oF)
Humidity 10 - 95% RH (relative humidity), non-condensing
Altitude Up to 2775 m (9000 feet)
Air Pressure 70 - 110 kPa
Electro-magnetic compatibility:
The A100 meets the requirements of EN60601-1-2
(Electromagnetic compatibility - requirements and tests).
12
5. INSTALLATION AND OPERATION
CAUTION
If the absorber has to be lifted or carried by hand,
always support the weight of the unit under the
base.
Do not lift the absorber by gripping any of the
components attached to the manifold blocks at the
top of the absorber – the manometer, APL valve,
breathing circuit connectors, etc.
Polemount bracket
A 25 mm (1 inch) diameter pole clamp is
provided on the rear of the absorber.
WARNING
The Penlon A100 Circle Absorber System must
only be used when securely mounted in an
upright position.
a) Non-return valves are gravity operated
b) Spillage of absorbent may contaminate the
breathing system.
13
INSTALLATION AND OPERATION
22 21
2
3
19
25
23 18
24
20
4
9
28 10
11
14
26 8
13
27
15
6 17 5
12
16
1. Bellows 9. Auxiliary Outlet on anaesthetic 19. Drive gas outlet - control unit to
2. Control unit machine (drive gas supply) bellows
3. Outlets to anaesthetic gas 10. Flow sample tubing connector - 20. Outlet - exhaust valve
scavenging system (AGSS) expiratory 21. Inlet - bellows drive gas
4. Bacterial filter 11. Flow sample tubing connector - 22. Outlet - to breathing system
5. Absorber valve block inspiratory 23. Input socket - Oxygen monitor
6. Heat and moisture exchanger 12 Sensor - pressure monitor sensor
(a combined unit with a bacterial 13. Expiratory valve - Absorber 24. Input socket - spirometer
filter can be used - see 5.1.8 in 14. Inspiratory valve - Absorber 25. Connector - pressure monitor
AV-S user manual) 15. Inlet - from Ventilator 26. APL valve
7. Patient 16. Connector - reservoir bag 27. Oxygen sensor
8. CGO Block on anaesthetic 17. Inlet - Absorber - fresh gas supply 28. Spirometer sensor unit
machine (Fresh Gas Supply) 18. Drive gas inlet - Ventilator
14
INSTALLATION AND OPERATION
15
INSTALLATION AND OPERATION
5.3 Filling and Changing CO2 1. Using pre-packed soda lime, the packing
seals must be removed from the fresh pre-
Absorbent pack following the makers’ instructions.
WARNING (a) Check that the canister is clean and empty
If the absorbent is to be changed during of dust or soda lime granules, including the
clinical use, the bypass switch (if fitted) must underside of the rubber seal.
be in the ‘Absorber OFF’ position, and an (b) Insert the pre-pack into the canister.
adequate fresh gas flow must be maintained Follow the instructions provided by the
to prevent excessive build up of CO2. pre-pack manufacturer.
2. Using bulk packed soda lime, check the
canister in the same manner, then place it
on a horizontal surface and fill it with soda
lime up to the MAX line, but not above it.
CAUTION
Efficient use of soda lime is only achieved if the
newly refilled canister is replaced in the upper
position.
1. Refit the canisters into the frame, with the
newly filled canister in the top position.
A
Make sure that all seals, and the
canisters align correctly as you tighten the
Removing the canisters clamp screw by clockwise rotation.
1. Turn the clamp wheel (A) fully clockwise (8
2. Leak test the absorber – see section 6.2.
to 9 turns) to leave space between the top
and bottom of the frame for the canisters to
be removed sideways after disengaging the
rubber seals by vertical movement. 5.4 Manometer
2. The absorbent in the lower canister is
always exhausted first, so the canisters The manometer is located on the top of the
should be rotated as follows: manifold block, to the rear of the expiratory valve.
To fit a manometer to an existing absorber, first
(a) lift the canisters from the frame and place
remove the blanking plug, then carefully screw
the top canister to one side, for refitment in
the adaptor into the manifold block. Fit the
the lower position,
manometer to the adaptor.
(b) replace the absorbent in the lower canister,
and then refit in the top position – see Function test the absorber, checking for leaks at
procedure below. the manometer, before clinical use.
17
PRE-USE CHECKS
G
6.6 On/Off Switch (if fitted)
1. Move the On/Off lever (G) to its horizontal ‘OFF’
position.
2. Select ‘Bag’ (models with a Bag/Ventilator option).
3. Pressurise the system and when the pressure in the
system reaches 3 kPa (30 cmH2O), turn off the flow
of gas.
4. Unscrew the clamp wheel (H) at the base of the
absorber, and detach the canisters.
5. Check that pressure is maintained i.e. system
pressure must not fall to zero in less than one minute.
6. Select ‘Absorber ‘ON’, check that the system exhausts
through the canisters.
7. Tighten the canister clamp wheel – check that the
canisters and seals align correctly during refitment.
H
18
7. MAINTENANCE
Service Frequency
Servicing and repairs must only be carried
out by Penlon-trained technicians and
engineers.
Weekly:
7.2 Canister and Seals 1. Attach a tube (A) to the drain trap tube
Cleanliness is the essential requirement for these and drain the condensate into a suitable
components. Soda lime tends to adhere strongly container such as a 100 ml beaker.
to surfaces when it has become exhausted.
Open the drain valve by turning the lever.
To ensure good sealing, the seals and the
canisters should be scrubbed under running 2. Allow all liquid to drain out, then close the
water to remove particles of soda lime, whenever drain valve.
these items are removed for recharging. Dilute the liquid with water before
Attention to the seal and sealing edge on disposal.
the frame is also important. These can be wiped
3. Remove the tube
with a wet cloth, or scrubbed under running water
when the complete system is dismantled for
sterilisation or disinfection.
See section 8.4.
19
MAINTENANCE
7.5 Manometer
The manometer must be removed from the absorber,
before any sterilisation or disinfection process is
applied to the absorber unit.
Depress the quick release clip to detach the
manometer from the adaptor on the absorber.
CAUTION Do not sterilise the manometer.
4. IMPORTANT
Check that the tubing is routed over the absorber
as illustrated (E).
20
8. STERILISATION
21
STERILISATION
WARNING
Condensation, which may collect in the bottom
of the absorber is caustic and care must be
taken not to spill it on the skin when draining the
trap provided. After draining ensure that the
drain valve is fully closed. See section 7.3
F C
CAUTION
When the absorber is lifted or carried by hand,
always support the weight of the unit under the
base.
Do not lift the absorber by gripping any of the
components attached to the manifold blocks at the
top of the absorber – the manometer, APL valve,
breathing circuit connectors, etc.
CAUTION
A
Do NOT clean any component in an automatic
cleaning/washing machine.
22
STERILISATION
Pressure gauge no no no – –
Oxygen monitor no no no – –
sensor
Spirometer tubing - refer to the user manual for the AV-S ventilator (section 6.3.1.2)
General Notes:
1. Thorough rinsing in warm water and drying in air should follow chemical disinfection.
2. Do NOT clean any component in an automatic cleaning/washing machine.
3. Before clinical use, ALWAYS carry out the Pre-use Checks listed in section 6 of this manual.
23
9. ORDERING INFORMATION
UK:
Tel: 01235 547036 Fax: 01235 547023 E-mail: uksales@penlon.co.uk
International:
Tel: +44 1235 547001 Fax: +44 1235 547021 E-mail: export@penlon.co.uk
USA
Penlon Inc.
11515 K-Tel Drive, Minnetonka, MN 55434
Note:
1. Absorber detachables consists of:
3 litre breathing bag
1.05 m (42 inch) breathing tube
Female mount
Connector mount
Facemask elbow
Y piece
2. All standard connectors are for use with 30 mm taper anti-pollution systems.
Models compatible with 19 mm systems are available on request.
APPENDIX 1
Disposal at end of useful life - risk assessment
24
Cat. No. 53036
Doc. No. CS EC 0310UI
September 2010
Technical Support
Tel: 44 (0) 1235 547076
Fax: 44 (0) 1235 547062
E-mail: technicalsupport@penlon.co.uk
UK Sales
Tel: 01235 547036
Fax: 01235 547023
E-mail: uksales@penlon.co.uk
International Sales
Tel: 44 (0) 1235 547001
Fax: 44 (0) 1235 547021
E-mail: export@penlon.co.uk
USA
Penlon Inc.
11515 K-Tel Drive
Minnetonka
MN 55434
USA