AirMed 1000 Instructions issue 4 Jan 2013

1 Contents 1. Introduction ------------------------------------------------------ Page 2 2. Product Identification -------------------------------------------- Page 2 3. Safety and Regulatory Information ----------------------------- Page 3 4. Operating Your Compressor Nebuliser ------------------------ Page 4 5. Notes on Nebuliser Care ---------------------------------------- Page 5 1. Replacing your consumables 2. Spares and Accessories 3. Optional Accessories

6. Replacement Parts & Optional Accessories ------------------- Page 5 7. Cleaning ---------------------------------------------------------- Page 6 8. Technical Specifications ----------------------------------------- Page 7 9. Guarantee -------------------------------------------------------- Page 8 10. Product Contents ---------------------------------------------- Page 8 11. Symbol Explanations ------------------------------------------ Page 9 12. EMC Declaration ----------------------------------------------- Page 9

2 1. Introduction Thank you for purchasing the AirMed 1000 Compressor Nebuliser. It is a compact medical device designed to efficiently deliver physician prescribed medication to the bronchial lung passages. With the correct care and use, it will provide you with many years of reliable treatment. This product is developed for the successful treatment of asthma, allergies and other respiratory disorders. It creates a stream of air that travels through a clear tube to the nebuliser. When air enters the nebuliser, it will convert the prescribed medication into aerosol mist for easy inhalation. Your Compressor Nebuliser should be used under the supervision of a licensed physician and/or a respiratory therapist. We encourage you to thoroughly read this handbook to learn about the features of this product. Any use of this product other than its intended use should always be avoided.

2. Product Identification 1. Nebuliser cup 2. Driveline

3. Mouthpiece 4. Power Lead 5. Mask

Driveline Connector Filter & Cover

Socket

Air Openings

Power Switch

3 3. Safety and Regulatory Information Note: Read all instructions carefully before use. The following basic precautions are needed when using an electrical product: Caution: Failure to read and observe all precautions could result in personal injury or equipment damage.

Product cautions:

1. To avoid electrical shock: Keep the unit away from water • Do not immerse the mains lead or the unit in liquid • Do not use while bathing • Do not reach for a unit that has fallen into water – immediately unplug the unit. 2. Never operate the unit if: • it has any damaged parts (including mains lead), • it has been dropped or submersed in water. 3. The unit should not be used where flammable gas, oxygen or aerosol spray products are being used. 4. Disconnect the unit from the electrical outlet before cleaning, filling and after each use. 5. Do not use other attachments unless recommended by manufacturer.

Operating cautions: 1. Connect this product to an appropriate voltage outlet for your model. 2. Do not run this product unattended. 3. Never operate if this unit has a damaged lead or plug, if it has been dropped into water. 4. If any abnormality occurs, discontinue use immediately until the unit has been examined and repaired. 5. Always unplug the product immediately after use. 6. Never block the air openings of the main unit or place it where the air openings may be obstructed.

Storage cautions: 1. Do not store the unit under direct sunlight, high temperature or humidity. 2. Keep the unit out of reach of small children. 3. Always keep the unit unplugged while not in use.

Cleaning cautions: 1. Do not immerse the unit in water. It may damage the unit. 2. Disconnect the unit from the electrical outlet before cleaning. 3. Clean all necessary parts after each use as instructed in this handbook. No modification of this equipment is allowed

4 4. Operating Your Compressor Nebuliser Note: Prior to initial operation, the nebuliser should be thoroughly cleaned. 1. Place your Compressor Nebuliser on a flat and stable surface. Be sure that you can easily reach the controls when you are seated. 2. Open the top cover. Important: Prior to initial operation, the nebuliser should be thoroughly cleaned referring to ‘Cleaning’, section 7, page 6 in the handbook. 3. Gently twist the top part of the nebuliser counter-clockwise to disassemble the nebuliser. 4. Fill the bottom section of the nebuliser with the medication prescribed by your physician. Be Place cone sure that the cone is put inside the bottom section. inside and fill with 5. Gently twist the top part clockwise to re-assemble medication the nebuliser. Be sure the two sections fit well. 6. Attach one end of air tube to the base of the nebuliser. 7. Attach the other end of air tube to the air tube connector located on the front of the compressor. 8. Attach mouthpiece or mask per your choice to the top section of nebuliser. 9. Plug the mains lead into an appropriate electrical outlet. Make sure at this stage, the power switch is at “OFF” status. 10. Press power switch to begin your prescribed treatment. Important: The compressor motor has a thermal protector which will shut the unit off before the unit is overheated. When the thermal protector shuts the unit off, please: a. Switch the unit off. b. Unplug the unit from the electrical outlet. c. Wait 30 minutes for the motor to cool down before another treatment. Make sure the air openings are not obstructed. 11. When treatment is finished, switch the unit off and unplug it from the electrical outlet. Please Note: The device should be positioned so that the AC adaptor and the mains plug are easily accessible to disconnect the device.

5 5. Notes on Nebuliser Care 1. Replacing your consumables

It is recommended that the following disposable items should be changed as follows:

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change every 3 - 4 months

Inlet filter

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change every 30 days or when it turns grey

Mouthpiece

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change every 6 - 12 months

Nebuliser chamber Air tube Face mask

2. Spares and Accessories The following are available from your supplier:

Inlet filter (Pack of 5)

Adult Year Pack: Contents: 4 nebuliser cups, 4 air tubes, 4 adult face masks, 5 inlet filters. Child Year Pack : As above but with a child’s face mask.

3. Optional Accessories: Travel bag

6. Replacement Parts & Optional Accessories Replacement parts are available through your local retailer or they can be ordered directly from Clement Clarke International Limited.

6 7. Cleaning It is recommended that the nebuliser, driveline (make sure the driveline is dry before re-use), mouthpiece and/or mask be thoroughly cleaned with warm water after each use and cleaned with a mild detergent after the last treatment of the day. If your physician or respiratory therapist specifies a different cleaning procedure, follow their instructions. Caution: Before cleaning, make sure the mains lead is disconnected from the mains outlet and the unit.

Rinsing (after each treatment) 1. 2. 3. 4. 5.

Disconnect the nebuliser cup, driveline, mouthpiece and/or mask. Gently twist the nebuliser cup to open it. Rinse the nebuliser cup, mouthpiece and/or mask with water. Dry them with a clean soft towel or let them air dry. Reassemble the nebuliser cup when completely dry and put the parts in a dry, sealed container.

Cleaning your accessories: This procedure does not sterilise the nebuliser cup. Therefore if the patient has an infectious disease, the entire nebuliser kit should be discarded. 1. 2. 3. 4. 5.

After use, disassemble and discard any residual drug. Wash the nebuliser parts in warm water with a little detergent. Rinse in clean warm water and allow to dry completely before re-assembly. Run empty for a few moments before next use. Store in a dry, clean place.

Cleaning the compressor: 1. Wipe daily with a damp cloth. 2. Do not use any powdered cleaners or soap pads, which may damage the finish.

Filter change 1. Do not use cotton or any other materials. Do not wash or clean the filter. Only use filters recommended by your manufacturer. Do not operate without a filter. 2. Change the filter every 30 days or when the filter turns grey. 3. Changing procedure: a. Remove the filter cover b. Replace the used filter with a new one. c. Replace the filter cover.

7 8. Technical Specifications Power Current Medication bowl capacity Particle Size MMAD Sound Level Average Nebulisation Rate Compressor Pressure Range Operating Pressure Range Litre Flow Range Operating Temperature Range Operating Humidity Range Storage Temperature Range Storage Humidity Range Dimension (L x W x H) Weight Standard Accessories

AC 230V, 50Hz 180VA 5ml (cc) 0.5 to 10 μ m 4μm Approx. 60 dBA (1m away) ≥ 0.2ml/min 29 to 43 Psi (200 to 300 kPa / 2 to 3 bar) 10 to 16 Psi (70 to 110 kPa / 0.7 to 1.1 bar) 4 ~ 8 L/m 10°C to 40°C (50°F to 104°F) 10 to 95% RH -25°C to 70°C (-13°F to 158°F) 10 to 95% RH 175 x 112 x 140 mm (6.88” x 4.41” x 5.5”) 1.38 kg (3.01 lbs) Mains Lead, Neb Cup, Driveline, Mouthpiece, Filters (5pcs), Face Mask (Adult & Child)

Protection against electric shock: - Class II Equipment - Type BF applied parts

Degree of safety in the presence of flammable anaesthetics or oxygen: - No AP/APG (Not suitable for use in the presence of flammable anaesthetics or oxygen)

Mode of operation: – continuous.

8 9. Guarantee This guarantee is offered to you as an extra benefit and does not affect your statutory rights. 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 below: The compressor and motor are guaranteed for 2 years from date of purchase, on condition that: • it is cleaned and maintained in accordance with the instructions. • any repair is undertaken by CCI approved engineers/agents. Please note: This device does not require a service under its guaranteed life. This guarantee does not apply to: • The disposable nebuliser cup, driveline, face mask, mouthpiece and filters. • Defects arising from misuse, negligence, improper maintentance, accident, damage in shipment or unauthorised modification or service. Compensation Defective parts only will be replaced. Terms and conditions apply

10. Product Contents 1 x Compressor Nebuliser Unit 1 x Instructions 1 x Neb Cup 1 x Mouthpiece 1 x Adult Face Mask 1 x Child Face Mask 1 x Driveline 5 x Air Filter

9 11. Symbol Explanations Consult ‘Instructions for Use’ Caution Manufacturer Class II Equipment Type BF applied parts This product complies with the essential requirements of the medical devices directive (93/42/EEC). Compliance has been verified by UK notified body per 0120 (SGS United Kingdom Ltd). Do not dispose of with household refuse

12. EMC Declaration With the increased number of electronic devices such as PCs 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 EN60601-1-2 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. Medical devices manufactured by Clement Clarke International Ltd conform to this EN60601-1-2 standard for both immunity and emissions. 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/ medicalquality

Clement Clarke International Ltd Edinburgh Way Harlow Essex CM20 2TT UK Tele: +44 (0)1279 414969 Fax: +44 (0)1279 456300 email: [email protected] Part no: 3605911 Issue no: 4 01/13

Trimmed size: 297 x 210 (A4), folded in half to 148.5 x 210mm (A5 booklet) Colour: 2 colour process: Pantone: 321, (C=100, M=0, Y=31 K=23) and Black. Material: 115gsm silk paper, cover - 250gsm Sample to be approved before initial production. Subsequent orders do not need a sample unless there is a change to the drawing