HS CLEMENT CLARKE INTERNATIONAL

HS CLEMENT CLARKE INTERNATIONAL Nebulisers

Actineb Operating Instructions issue 7 Jan 2012

Operating Instructions

2 Pages

Troubleshooting Guarantee Problem Action Air compressor will not operate when switched on. If the switch is on, yet the motor does not function, 1. Check mains lead is securely inserted into wall socket. 2. For machines with a 3 pin plug (UK) remove and check the fuse in the plug. If it still does not function there is an internal fault. The machine should be returned to the point of purchase or an authorised person for examination. This guarantee is offered to you as an extra benefit and does not affect your statutory rights. Nebuliser chamber bubbles or produces little or no mist. 1. Check inlet filter. Replace if necessary. 2. Wash nebuliser chamber. Replace if problem still occurs. 3. Check driveline tubing is not kinked or leaking. Replace if necessary. 4. Service compressor. (Return to point of purchase) Time taken to nebulise increases significantly. This device conforms to: - the Medical Devices Directive 93/42/EEC - BS EN 60601-1 Medical Electrical Equipment General Requirements for Safety - BS EN 60601-1-2 Electromagnetic compatibility of medical electrical equipment - EN13544-1 Respiratory Therapy Equipment (Part 1) Replacing the Inlet Filter Disc Ensure sealed side of white filter disc is uppermost when inserting into the filter holder, so that when replacing disc holder, the sealed side is facing down. white filter disc sealed side uppermost CCI products are carefully designed, manufactured and inspected. CCI undertake to replace or repair any part found to be defective in material or workmanship subject to the following terms and conditions: The compressor and motor are guaranteed for 3 years on condition that: ● it is cleaned and maintained in accordance with the instructions. ● any servicing or repair is undertaken by CCI approved engineers/agents. ● only CCI approved parts are used to service this equipment. ● The facia and outer casing are guaranteed for one year. This guarantee does not apply to: ● The disposable nebuliser chamber, driveline, face mask, mouthpiece and filters. ● Defects arising from misuse, negligence, improper maintentance, accident, damage in shipment or unauthorised modification or service. To register this guarantee please return the card, supplied with this handbook, within 15 days of purchase. CCI shall not be liable for any third party or consequential loss or damage of whatever nature arising from or in connection with this equipment. Should it become necessary to make a claim under guarantee, return the unit properly packed (preferably in the original packaging) to the point of purchase (the manufacturer, shop, distributor or outlet where the device was purchased). Please include name and address, details of problem and proof of date of purchase (please retain original invoice). Carriage costs to be paid by the customer, which will be refunded if the fault is deemed to be a manufacturing defect and the conditions above are satisfied. Proof of costs are needed for carriage refund. EMC (Electro Magnetic Compatibility) Declaration With the increased number of electronic devices such as PC’s and mobiles, medical devices in use may be susceptible to electromagnetic interference from these devices. Which may result in incorrect operation of the medical device and create a potentially unsafe situation. Medical devices should also not interfere with other devices. In order to regulate the requirements for EMC with the aim to prevent unsafe product situations, the EN606011-2 standard has been implemented. This standard defines the levels of immunity to electromagnetic interferences as well as maximum levels of electromagnetic emissions for medical devices. disc holder Step 1 Step 2 Nevertheless, special precautions need to be observed: The use of accessories and cables other than those specified by Clement Clarke Int. Ltd, with the exception of cables sold by Clement Clarke International Ltd. as replacement parts for internal components, may result in increased emission or decreased immunity of the device. The medical devices should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is unavoidable, the medical device should be seen to operate normally as it should in this situation. Further guidance regarding the EMC environment (in accordance with EN60601-1-2) in which the device should be used is available at www.clement-clarke.com Trimmed size: 396 x 210mm Colour: Blue Pantone 293 Please read these instructions before using the equipment Please visit our e-shop at www.clement-clarke.com/shop Inlet Filter disc (Pack of 4)... 3604777 Adult Year Pack... L3103001 Contents: 4 nebuliser chambers, 4 drivelines, 4 adult face masks, 4 inlet filter discs. Clement Clarke International Limited, Edinburgh Way, Harlow, Essex CM20 2TT Telephone: +44 (0)1279 414969 Fax: +44 (0)1279 456300 www.clement-clarke.com e-mail: resp@clement-clarke.com Child Year Pack... L3702080 As above but with a child's face mask. 5 MEDIX Nebuliser System Medical devices manufactured by Clement Clarke International Ltd conform to this EN60601-1-2 standard for both immunity and emissions. Spares and Accessories sealed side facing down Operating Instructions for the 6 7 Part no: 1902904 Issue no: 7 01/12

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File Name: HS CLEMENT CLARKE INTERNATIONAL - Actineb Operating Instructions issue 7 Jan 2012 - 2012-01.pdf

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Page 1

Troubleshooting

Guarantee

Problem

Action

Air compressor will not operate when switched on.

If the switch is on, yet the motor does not function, 1. Check mains lead is securely inserted into wall socket. 2. For machines with a 3 pin plug (UK) remove and check the fuse in the plug. If it still does not function there is an internal fault. The machine should be returned to the point of purchase or an authorised person for examination.

This guarantee is offered to you as an extra benefit and does not affect your statutory rights.

Nebuliser chamber bubbles or produces little or no mist.

1. Check inlet filter. Replace if necessary. 2. Wash nebuliser chamber. Replace if problem still occurs. 3. Check driveline tubing is not kinked or leaking. Replace if necessary. 4. Service compressor. (Return to point of purchase)

Time taken to nebulise increases significantly.

This device conforms to: - the Medical Devices Directive 93/42/EEC - BS EN 60601-1 Medical Electrical Equipment General Requirements for Safety - BS EN 60601-1-2 Electromagnetic compatibility of medical electrical equipment - EN13544-1 Respiratory Therapy Equipment (Part 1)

Replacing the Inlet Filter Disc Ensure sealed side of white filter disc is uppermost when inserting into the filter holder, so that when replacing disc holder, the sealed side is facing down. white filter disc

sealed side uppermost

CCI products are carefully designed, manufactured and inspected. CCI undertake to replace or repair any part found to be defective in material or workmanship subject to the following terms and conditions: The compressor and motor are guaranteed for 3 years on condition that: ● it is cleaned and maintained in accordance with the instructions. ● any servicing or repair is undertaken by CCI approved engineers/agents. ● only CCI approved parts are used to service this equipment. ● The facia and outer casing are guaranteed for one year.

This guarantee does not apply to: ● The disposable nebuliser chamber, driveline, face mask, mouthpiece and filters. ● Defects arising from misuse, negligence, improper maintentance, accident, damage in shipment or unauthorised modification or service. To register this guarantee please return the card, supplied with this handbook, within 15 days of purchase. CCI shall not be liable for any third party or consequential loss or damage of whatever nature arising from or in connection with this equipment. Should it become necessary to make a claim under guarantee, return the unit properly packed (preferably in the original packaging) to the point of purchase (the manufacturer, shop, distributor or outlet where the device was purchased). Please include name and address, details of problem and proof of date of purchase (please retain original invoice). Carriage costs to be paid by the customer, which will be refunded if the fault is deemed to be a manufacturing defect and the conditions above are satisfied. Proof of costs are needed for carriage refund.

EMC (Electro Magnetic Compatibility) Declaration With the increased number of electronic devices such as PC’s and mobiles, medical devices in use may be susceptible to electromagnetic interference from these devices. Which may result in incorrect operation of the medical device and create a potentially unsafe situation. Medical devices should also not interfere with other devices. In order to regulate the requirements for EMC with the aim to prevent unsafe product situations, the EN606011-2 standard has been implemented. This standard defines the levels of immunity to electromagnetic interferences as well as maximum levels of electromagnetic emissions for medical devices.

disc holder Step 1

Step 2

Nevertheless, special precautions need to be observed: The use of accessories and cables other than those specified by Clement Clarke Int. Ltd, with the exception of cables sold by Clement Clarke International Ltd. as replacement parts for internal components, may result in increased emission or decreased immunity of the device. The medical devices should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is unavoidable, the medical device should be seen to operate normally as it should in this situation. Further guidance regarding the EMC environment (in accordance with EN60601-1-2) in which the device should be used is available at www.clement-clarke.com

Trimmed size: 396 x 210mm Colour: Blue Pantone 293

Please read these instructions before using the equipment Please visit our e-shop at www.clement-clarke.com/shop

Inlet Filter disc (Pack of 4)... 3604777 Adult Year Pack... L3103001 Contents: 4 nebuliser chambers, 4 drivelines, 4 adult face masks, 4 inlet filter discs.

Clement Clarke International Limited, Edinburgh Way, Harlow, Essex CM20 2TT Telephone: +44 (0)1279 414969 Fax: +44 (0)1279 456300 www.clement-clarke.com e-mail: [email protected]

Child Year Pack... L3702080 As above but with a child's face mask.

MEDIX Nebuliser System

Medical devices manufactured by Clement Clarke International Ltd conform to this EN60601-1-2 standard for both immunity and emissions.

Spares and Accessories sealed side facing down

Operating Instructions for the

Part no: 1902904 Issue no: 7 01/12

Filling the Nebuliser Chamber For Single Patient Use 1 Connect one end of the driveline to the outlet nozzle on your compressor.

This nebuliser system is designed to deliver a fine aerosol mist from the liquid medication prescribed by your doctor to treat your respiratory condition. Use according to the instructions given by your doctor or physician. Please read the instructions carefully to obtain the maximum benefit from this nebuliser system. This mains only nebuliser system has been designed to operate from 230V ~ 50Hz (UK/EU versions, model 3604700/3604701) The

2 Connect the other end of the driveline to the bottom of the nebuliser cup.

3 Remove the nebuliser chamber top from the cup and pour medication into the cup (max 10ml.)

1 x adult face mask 1 x inlet filter disc

4 Screw the top back onto the cup.

Mains AC Operation 1 Open rear door. (Leave open during operation). 2 Connect mains plug to mains power supply. 3 Connect driveline to outlet nozzle. 4 Connect nebuliser chamber, followed by face mask or mouthpiece (optional extra), to the driveline. (see below) 5 Press mains switch on. The equipment will now operate. Note: The Actineb can be used for treatment up to 1 hour. Do not re-use within 1 hour.

3604700HWUK/3604701HWEU

Region

UK/EU

5 Connect either the face mask or mouthpiece to the nebuliser top.

152W

Fuse

Mains Plug UK - Fuse 3A

Nominal Flow

7.0 L/min @ 100 kPa (1bar) with Microneb III

All accessories must comply with EN 13544-1

Weight, approx.

2.3 kg (device weight) 2.8 kg (boxed weight)

Dimensions (mm)

282mm x 200mm x 125mm

Administering the Medication Switch the compressor unit on. Sitting in an upright relaxed position, place face mask over the nose and mouth or mouthpiece into the mouth, and start breathing slowly and deeply. Do not try to breathe quickly. If you have any problems, seek instruction from your physician. Switch off the compressor when the misting has stopped. Unplug the mains lead.

mains switch inlet filter outlet nozzle

Cleaning

In order that you benefit fully from your equipment, it is important that the machine and accessories are kept in a clean condition. Ensure that the medication chamber is taken apart and washed in warm soapy water, rinsed and allowed to dry completely after each use. The jet holes should be blown clear by attaching the chamber to the air outlet from the compressor, then run the machine for a few moments. We advise that the tube is disconnected from both the outlet nozzle and the chamber after each use to prolong the life of the connector. The case should be wiped with a clean cloth using a mild detergent solution. It is recommended that the following disposable items should be changed as follows: Nebuliser chamber Inlet filter disc change every 3 - 4 months Driveline Face mask Mouthpiece } change every 6 - 12 months Only nebuliser chambers supplied or approved by CCI should be used.

Transport and Storage

No specific environmental conditions for transport/storage applies to this device.

Symbols

Classification

Class II, Type BF applied part

Residual Volume

0.4 ml

Aerosol Output Rate

0.38 ml/min

Sound Pressure Level approx.

Without neb-cup 60.6 dbA, with neb-cup 63.3 dbA

Use Conditions

10˚C to +40˚C (recommended) 20%RH to 80%RH

100%

1 Do not immerse machine in water. 2 Physician prescribed use only. 3 Never use more frequently than prescribed. 4 If therapy is having no effect, consult physician.

}

230v / 50Hz

Power Consumption

Consult ‘Instructions for Use’ Caution, consult accompanying documents for important safety-related information, such as warnings etc.

Alternating Current Inlet filter

Actineb + Microneb III

Outlet filter

90%

Mains 'On'

80% 70%

Mains 'Off'

60%

Class II Equipment

50% 40%

Type BF applied part

30% 20%

0120

10% 0% 0.1

Caution: Do not immerse in water.

Model

Caution

Replacement

Rated voltage

Note: When running, the Actineb may interfere with the performance of radio receiving equipment.

Operating Instructions

any maintenance or cleaning. ∗ Never operate the unit where it may come into contact with water. Should this happen, switch off at mains and unplug immediately. ∗ Never block air intake grills on the side of the device. ∗ Always keep electrical leads clear of heated surfaces. ∗ Position the unit on a clean surface. Do not place on carpet where fibres can be drawn into the unit when in use. ∗ Avoid using in a room where people smoke. ∗ Store in a clean dry dust free environment at room temperature. ∗ Not suitable for use with flammable anaesthetic gases. ∗ Do not modify the equipment or its accessories in any way.

Technical Description

is supplied with a kit consisting of:

1 x nebuliser chamber 1 x driveline

∗ Always disconnect from electricity supply before undertaking

Cumulative Mass

Introduction

Notes on Nebuliser Care

Safety Precautions

Aerodynamic diameter (µm)

100

This product complies with medical devices directive (93/42/EEC), meeting requirements for safety and product performance.

Do not dispose of with household refuse

Note:

Unit must be operated with the rear door open at all times.

The performance information provided is in accordance with standard EN 13544-1 but may not apply to drugs supplied in suspension or high viscosity form. In these cases, information should be sought from the drug supplier.

60 mins on - 60 mins off

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