User Manual
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CLEMENTS
eVAC Hand Operated Suction Pump SUC 82015
User Manual Manual No. SUC 82015 003 Issue 8
CLEMENTS
Safety Thank you for purchasing this Clements eVAC Hand Operated Suction Pump. For your safety it is imperative that this unit only be operated by authorised personnel in accordance with the instructions as described in this manual. Operated in this way, the eVAC Hand Operated Suction Pump will provide years of service. Due to continual improvements in product design, the eVAC Hand Operated Suction Pump may vary in detail from the descriptions in this manual. In the event of further questions please contact your local distributor or BMDi TUTA Healthcare direct.
User Manual eVAC Hand Operated Suction Pump Manual Number SUC 82015 003 Issue 8 Copyright © 2016 BMDi TUTA Healthcare Pty Ltd The information in this manual was originated by, and is the exclusive property of BMDi TUTA Healthcare Pty Ltd. It is furnished for customer information only, and is not an authorisation or licence to make this product or to furnish this information to others.
Sponsor: Hangzhou Jinlin Medical Appliance Co Ltd M14-3-4 Hangzhou Economic & Technological Development Zone Hangzhou 310018 Zhejiang PRC
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BMDi TUTA Healthcare Pty Ltd Unit 4B, 128-130 Frances St Lidcombe NSW 2141 Australia Phone: +61 2 9466 5300 Website: www.medaust.com
CLEMENTS Contents Classifications ...
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Specifications...
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Description ...
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Directions For Use ...
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Cleaning And Disinfecting ...
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Basic Function Test ...
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Maintenance ...
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Cleaning And Cautions ...
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Disposal and Recycling...
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Spare Parts ...
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Warranty ...
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Contents
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CLEMENTS Identification SUC 82015 eVAC Hand Operated Suction Pump
Intended Use To provide a continuous vacuum source, within the stated operating vacuum range, for the aspiration of fluids and particulate matter in medical procedures carried out by clinically trained and authorized personnel.
Uninterrupted Availability This equipment is manually powered. If patient care requires the uninterrupted availability of a source of continuous vacuum, the clinical facility must make provision for either a backup power supply or standby suction units which are battery or manually powered.
Classifications
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GMDN Code
36776
GMDN Term
Suction Unit, Manually-powered
GMDN Synonym
Aspirator
Device Class
Class I
Sterilisation
Not supplied in sterile state
Anaesthetic Rating
NOT Category AP NOT Category APG
Operation Mode
Continuous operation within the limits of manual operation
Classifications
CLEMENTS Specifications Vacuum Range
0 to -73kPa [0 to –550 mmHg]
Maximum Flow Rate
Peak > 20 litre/min
Collection Jar Volume
300 ml
External Diameter of Cap (Suction Port)
17 mm
External Diameter of Cannula Connection
13 mm and 6 mm
Operating Ambient Requirement
-20 °C to +50 °C
Storage Ambient Requirement
-40 °C to +60 °C
Unit Dimensions
198 x 74 x 169 mm
Unit Weight
247 grams
Packed Dimensions (Unit)
230 x 180 x 80 mm 0.385kg
Packed Dimensions (10 Pack)
460 x 430 x 210mm 4.5kg
**Specifications given are achievable under test conditions and may vary during actual use. **
Warning Symbols Legend The warning symbols marked on the equipment and their meanings are shown as follows.
Attention, consult accompanying documents
Specifications
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CLEMENTS Description The eVAC Hand Operated Suction Pump is a light, state of the art, high-vacuum, portable emergency device, which can be powered with one-hand operation, leaving the other hand free for different tasks. It was designed with a swivel which gives the operator better accessibility whilst working in tight situations and avoids premature engagement of the overflow mechanism. The unit has been designed to provide efficient operation and simple maintenance. Cap Connection Port
Hand Pump
Suction Cannula Connector
Collection Jar
Directions For Use Select the appropriately sized suction cannula and connector according to the size of the patient. Attach Connector and Suction Cannula to the Cap Connection Port of the Collection Jar. Attach Pump Handle to the Cap Connection Port. Ensure that the Collection Jar is firmly attached to the Cap Connection Port. Caution: It very important that the Collection Jar Cap is attached all the way to the Pump Handle, and that all connections are tight and firm. The eVAC Hand Operated Suction Pump is operated by a simple squeeze action of the trigger. Pull or squeeze the trigger towards the Pump Handle to create the vacuum in the pump, and fluid will be suctioned into the Collection jar. A one-way valve mechanism prevents loss of suction.
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Description / Directions For Use
CLEMENTS
Once suctioning is finished, remove the tube slowly from the patient. Unsnap the filled Collection jar and Cannula from the Pump Handle. Place the filled Jar and tubing into a poly bag; seal bag and dispose of appropriately. Overflow Protection Mechanism The eVAC Hand Operated Suction Pump is equipped with an overflow protection mechanism which will engage once the jar is filled. It is not possible to continue squeezing the handle once the Collection Jar is full; extremely high resistance will be felt. When this happens, empty the Collection Jar or replace with a back-up jar for further suctioning. The overflow protection mechanism will ensure that the fluid will not enter the housing of the Pump Handle assembly once the Collection Jar is full. When the suction port of the cap is pointed towards the floor, a flapper valve will close to avoid spilling the aspirated contents from the Collection Jar. If the tip of the Suction Cannula becomes blocked, increased resistance will be felt and the Pump handle will become difficult to operate. Do not continue suctioning and lift the Suction Cannula away from the occlusion. Remove the blockage from the tip of the Cannula by disconnecting and shaking until clear, or replace with a fresh cannula. If the pump is turned upside down, the overflow protection mechanism will be engaged and it will be impossible to suction. If a sudden resistance is felt during suctioning and the Collection Jar is not full, then the overflow protection mechanism may have become engaged. Disconnect the Collection Jar from the Pump to release the vacuum; shake the jar slightly to reset and reconnect. This should disengage the overflow protection mechanism. Note: When disconnecting the Collection Jar from the Pump, it is important to pull apart to separate-do NOT twist. Twisting can result in damage to the end stops.
Directions For Use
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CLEMENTS Cleaning And Disinfecting If the suction pump was contaminated, disinfect the pump and handle (by scouring with warm soapy water, mild detergent, bleach solution, etc) before placing into storage. Caution: Do NOT immerse the pump unit in liquid.
Basic Functional Test It is important to check the pump function before returning it for use. Mount a Collection Jar , occlude the Connection Port with your thumb or palm and squeeze the handle to check the vacuum.
Maintenance Apart from the cleaning and testing procedures referred to above the eVAC Hand Operated Suction Pump requires no special maintenance or storage conditions.
Cautions Read directions prior to use. The eVAC Hand Operated Suction Pump should be used by persons with training in suction techniques. The use of the suction device may require that appropriate infectious disease precautions be taken during use, cleaning of the device, and disposal of the tubing and the Collection Jar (as per local protocol).
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Maintenance
CLEMENTS Disposal and Recycling Waste Materials The contents of the collection jar, cannulae, may contain biohazard wastes. Handle using safe handling procedures, which may include the use of rubber gloves and eye protection, and dispose of according to local protocols for biohazard materials.
Recycling At the end of their service life, the pump and accessories should be dismantled if necessary, and disposed of according to local requirements.
Spares Parts Catalogue SUC 82015
eVAC Hand Operated Suction Pump with Collection Jar and Cannula Kit
SUC 82015 001
300ml Collection Jar and Cap for eVAC Hand Operated Suction Pump
SUC 82015 002
Cannula Kit for eVAC Hand Operated Suction Pump with 1 x Large Cannula, 1 x Small Cannula
SUC 82015 003
User Manual for eVAC Hand Operated Suction Pump
Spare Parts
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CLEMENTS Warranty BMDi TUTA Healthcare Pty Ltd warrants that this product is free from
defects in workmanship and materials for a period of 12 months (3 months for batteries) from the date of shipment by BMDi TUTA Healthcare Pty Ltd or its authorised agent to the purchaser. Subject to the conditions of this warranty, if the product fails to operate for any reason within the warranty period and the product is returned to the place of purchase at the purchaser's expense, Medical Australia Limited will repair or replace the product free of charge. If a valid warranty claim is made within 30 days from the date of shipment, then BMDi TUTA Healthcare Pty Ltd will also reimburse the purchaser for reasonable freight costs in returning the product to the place of purchase. Conditions of Warranty 1.
The product must be returned to the place of purchase with proof of purchase.
2.
This warranty is only available to the original purchaser of the product.
3.
The product must not have had its serial number removed, defaced or changed, its casing opened, its power supply altered or have been tampered with in any other way.
4.
This warranty does not cover : • inadequate or incorrect site preparation; • improper installation; • connection to the wrong voltage; • failure of the product due to misuse; • the use or operation of the product outside of the physical, electrical or environmental specifications of the product; • use in a manner or environment in which the product is not designed to be used; • improper adjustment, calibration or operation by the purchaser;
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Warranty
CLEMENTS
• the use of accessories including consumables, hardware or software which were not manufactured or approved in writing by BMDi TUTA Healthcare Pty Ltd ; • any modifications of the product which were not authorised in writing by Medical Australia Limited; • any contamination or leakages caused or induced by the purchaser; and • inadequate or improper maintenance of the product. 5.
This warranty does not cover normal wear and tear.
6.
BMDi TUTA Healthcare Pty Ltd will not be responsible for damage or loss caused during shipping.
7.
In Australia, apart from any warranties implied by the Trade Practices Act 1974 all other warranties expressed or implied and whether arising by virtue of statute or otherwise are hereby excluded.
8.
Outside Australia, all other warranties expressed or implied and whether arising by virtue of statute or otherwise (including any warranties implied by the Vienna Convention) are hereby excluded.
9.
BMDi TUTA Healthcare Pty Ltd obligations under this warranty are limited to the repair or replacement of the product, within the terms of this warranty and the total liability of BMDi TUTA Healthcare Pty Ltd for loss or damage of every kind whether arising pursuant to the terms of the sale of the product or otherwise in connection with the product is limited to the amount paid by the purchaser to BMDi TUTA Healthcare Pty Ltd for the product.
10. Apart from any liability imposed by Part VA of the Trade Practices Act, BMDi TUTA Healthcare Pty Ltd accepts no other liability for any loss or damage occasioned (including consequential loss or damages) in any way as a result of the use of the product. 11. The warranty does not extend to cover damage to the following parts as they are inherently prone to wear : •
motor brushes
12. This warranty does not extend to cover corrosion due to any cause nor to any damage to painted or anodised surfaces. 13. BMDi TUTA Healthcare Pty Ltd will give the purchaser the benefit of any manufacturer's warranty in respect of any components in the product which were not manufactured by BMDi TUTA Healthcare Pty Ltd , if such a manufacturer's warranty is available.
Warranty
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