SRT IIICPAP Users Manual Model No 9S-003 Series

Contents Important Safeguards.………….………………..…………………….…………1 1. Introduction…...……………………………………………….………….…….3 2. Product Description….……………………………………………….….…….4 3. Installation.………………..…………………………………..…...…...…..…..5 4. Operation ………………...…………………………...…..……………...…… 7 5. Cleaning & Maintenance………………..……………………………………11 6. Troubleshooting ………...…………………..……..…….………...………...12 7. Technical Specification.………..….……………...……….………….….…..13 8. Note, Caution and Warning Statements. ….…………..……………..…….13

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IMPORTANT SAFEGUARDS SAVE THESE INSTRUCTIONS READ ALL INSTRUCTIONS BEFORE USING WARNING – 1. THIS DEVICE IS NOT INTENDED FOR LIFE SUPPORT. It may stop operating due to power interruption but no hazards to patient. 2. This device should not be used with oxygen. 3. This device should not be used in the vicinity of a flammable anaesthetic mixture in combination with oxygen or air and nitrous oxide. 4. The airflow for breathing generated by this device may be as much as 7°C (12.6°F) higher than the room temperature. This device SHOULD NOT be used if the room temperature is warmer than 35°C (95°F) to prevent the airflow temperature from exceeding 40°C (104°F) and causing irritation to your airway. 5. If this device overheats, it will stop operating and show Error Message “[E 002]” on the display. After cooling down to proper temperature, the device can be restarted again. 6. This machine should be used only with masks (and connectors) recommended by the manufacturer, or by your physician or respiratory therapist. A mask should not be used unless the CPAP machine is turned on and operating properly. The vent holes in the mask should never be blocked for proper exhalation. 7. At low CPAP pressure, some exhaled gas may remain in the mask and be rebreathed. NOTE – • U.S. Federal law restricts this device to sale by or on the order of a licensed physician. • This device is not recommended for use with a passover-humidifier except indicated by physicians.

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DANGER -To reduce the risk of electrocution: 1. 2. 3. 4. 5.

Always unplug this product immediately after use. Do not use while bathing. Do not place or store product where it can fall or be pulled into a tub or sink. Do not place in or drop into water or other liquid. Do not reach for a product that has fallen into water. Unplug immediately.

WARNING -To reduce the risk of burns, electrocution, fire or injury to persons: 1. 2. 3. 4.

5. 6.

7. 8.

This product should never be left unattended when plugged in. Close supervision is necessary when this product is used by, on, or near children, invalids or disable persons. Use this product only for its intended use as described in this manual, do not use attachments not recommended by the manufacturer. Never operate this product if it has a damaged cord or plug, if it is not working properly, if it has been dropped or damaged, or dropped into water. Return the product to a service centre for examination and repair. Keep the cord away from heated surfaces. Never block the air openings of this product or place it on a soft surface, such as a bed or couch, where their openings may be blocked. Keep the air opening free of lint, hair, and other similar particles. Never drop or insert any object into any opening or hose. Follow the national requirement to dispose the unit.

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1. Introduction This manual should be used for initial set up of the system and saved for reference purpose. 1.1 General Information Obstructive Sleep Apnoea (OSA) is a condition characterised by intermittent and repetitive obstruction of the upper respiratory tract causing a complete (apnoea) or partial (hypopnea) blockade of airflow during sleep. The syndrome varies in severity depending on the degree of relaxation of the tongue and soft palate muscle. The most common treatment for OSA is Continuous Positive Airway Pressure (CPAP). CPAP devices can deliver a constant air pressure into your upper airway via a nasal mask. This constant air pressure can keep your airway open during sleep, therefore prevents the OSA. This device is a micro-processor controlled continuous positive airway pressure device. It features an illuminated, menu-driven LCD display, ramp time adjustment, altitude compensation, compliance meter, and total operating meter. The quiet operation also ensures that you fall asleep comfortably. The compliance meter/ total meter provide the usage record for physician’s reference. The system has been tested and successfully approved to the following standards: EN 60601-1 EN 60601-1-2 EN 55011 Class B IEC 61000-4-2 0197 0197 IEC 61000-4-3 IEC 61000-4-4 IEC 61000-4-5 IEC 61000-4-6 IEC 61000-4-8 IEC 61000-4-11 EN 61000-3-2 Class A EN 61000-3-3

E228589 53DG

Medical Equipment- CPAP with respect to electrical shock, fire and mechanical hazards only in accordance with UL60601-1 and CAN/CSA C22.2 No. 601.1

Le produit à été testé avec des équipements médicaux et respecte les normes UL 60601-1 & CAN/CSA C22.2 No. 601.1. prévenant les choc électrique, le feu et les risques de blessures physiques. 1.2 Intended Use This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult Obstructive Sleep Apnoea (OSA).

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2 Product Description Components include: (1) Main CPAP device (2) Detachable power cord (3) User manual (4) Flexible air tubing with 1.8 m length (5) Nasal mask and headgear straps (Optional, Always use CE certified and 510(k) cleared mask for CPAP) (6) Carrying bag (optional) (7) USB cable and Easy Compliance CD (Optional) Note 1: ONLY for Physician or Technician to download data. Patient should not use this function. Note 2: Only applicable for devices with USB port. CAUTION – Patient should not connect the device to a personal computer for data downloading. This may cause the CPAP system failure.

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3. Installation 3.1 Unpacking To secure its contents inside, the CPAP device and accessories are bundled in a foam packaged box (environmentally friendly). Unpack this box by removing the CPAP and enclosed accessories. Please check for any damage that may have occurred during shipping. If there are damages, please contact your dealer immediately.

3.2 Setting Up 1) Connect the power cord to the CPAP device and plug into main electrical outlet. Once the power cord is plugged into the electrical outlet, the device is in standby mode.

2) Insert the air tubing firmly to the air outlet of CPAP.

3) Connect the nasal mask to the other end of the air tubing.

4) Strap the headgear to the nasal mask (follow steps 1, 2, 3, 4). Fit the nasal mask on your face and adjust the headgear straps till you have a comfortable fit. (Please refer to the instruction manual packed with the accessories)

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3.3 WARNING & CAUTION

WARNING:

This CPAP machine should be used only with special masks (or connectors) recommended by the manufacturer of the CPAP machine, or by your physician or respiratory therapist. A mask should not be worn unless the CPAP machine is turned on and operating properly. The vent hole in the mask should never be blocked for proper exhalation. If the device air outlet is blocked, the CPAP machine will stop and show message “[E 002]”, after cooling down, please re-connect the power cord to reset the machine.

WARNING:

When the CPAP is not in operation, oxygen may accumulate within the CPAP device enclosure, and it may create the risk of fire. This warning applies to most of the CPAP models.

WARNING:

This device SHOULD NOT be used if the room temperature is warmer than 35°C(95°F) to prevent the temperature of air delivered to nasal mask over 40°C(104°F).

WARNING:

This device SHOULD NOT be used in the vicinity of a flammable anaesthetic mixture in combination with oxygen or air and nitrous oxide. L’équipement ne peut être utilisé s’il y a risque de mélange d’un anesthésique inflammable avec l’air ou l’oxygène ou oxyde nitreux. At low pressures, some exhaled gas may remain in the mask and be rebreathed.

CAUTION: CAUTION:

Make sure the environment around the machine is dry and clean. Dust and foreign particles may affect the treatment. Keep the air inlet on the back of the machine clear to prevent overheating and damage of the device. Do not place the machine near a source of hot or cold air. Extreme cold or hot environment may damage user's respiratory airway.

CAUTION:

Do not connect the device to a personal computer for data downloading during the treatment. This may cause failure of the CPAP system.

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4. Operation

NOTE: Always read the operating instruction before use. 4.1 Control Panel Description Buttons arrangement on control panel and main use of the buttons:

START/STANDBY Š To start the treatment, simply press the "START/STANDBY" button. To stop the treatment, press the "START/STANDBY" button again. The display will switch between [STANDBY] and Current Pressure [P XX.X] in cmH2O unit. MENU Š Press the "MENU" button to enter the setting mode when device is in standby mode. The adjustment setting includes ramp time selection, ramp starting pressure, altitude compensation, therapy pressure adjustment, compliance meter, and total operating meter. When the value of each setting has been changed, press "MENU" for confirmation and press "MENU" again for next setting selection. Please refer to 4.2 Function Description section for detailed information.

UP Press the "UP" button to select a higher value.

DOWN Press the "DOWN" button to select a lower value. 7

4.2 Function Description (1) Ramp Time Ramp time function allows user to fall into sleep with a lower, comfortable pressure and helps users gradually accustomed to increasing treatment pressure. The first selection of pressing "MENU" is [R XX MIN]. When the "MENU" setting is in [R XX MIN] mode, press "UP" or "DOWN" button to set the preferred ramp time and then press "MENU" for confirmation. There are 10 adjustable levels, 0, 5, 10, 15, 20, 25, 30, 35, 40 and 45 minutes. For example, if the therapy pressure is set at 10 cmH2O and the ramp time is set at 20 minutes, then the actual pressure will increase from ramp starting pressure (selectable by user, see 4.2.2)) to therapy pressure 10 cmH2O in 20 minutes.

Ramp starting pressure

(2) Ramp Starting Pressure Press "MENU" button to select [R-P XX.X] menu, press "UP" or "DOWN" button to set the preferred ramp starting pressure and press "MENU" for confirmation. The ramp start pressure can be changed from 3 cmH2O to “Therapy Pressure – 1” cmH2O. For example, if your therapy pressure is 10 cmH2O, the maximum ramp starting pressure you can select is 9 cmH2O.

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(3) Altitude Compensation Press "MENU" button to select [AT XXX] menu, press "UP" or "DOWN" button to set the preferred altitude compensation level – LOW, MEDIUM or HIGH. The level should be set depending on your location regarding sea level. Once the preferred level has been selected, press "MENU" for confirmation.

LOW

0 - 2600 ft

0 - 800 m

MEDIUM HIGH

2601 - 5200 ft 5201 – 8000 ft

801 - 1600 m 1601 – 2400 m

NOTE – Altitude compensation setting is mainly for the sensitivity adjustment for low pressure alarm at mask off or leakage situation. This device equipped with pressure sensory feedback mechanism by PWM control. Whenever air leakage or mask off occurs, the device will compensate more PWM value to achieve the targeted pressure.

(4) Therapy Pressure Press "MENU" button to select [P XX.X] menu, you can view the current pressure setting displayed in cmH2O unit. Therapy pressure is adjustable only by the physician/technician. (5) Compliance Meter Press "MENU" button to select [CM XXXX.X] menu, the compliance meter records the time during which the patient has breathed with the device. The compliance meter is displayed in Hour unit, and can be re-set only by the physician/technician. (6) Total Meter Press "MENU" button to select [TM XXXX.X] menu, the total meter records the total device operating time displayed in Hour unit. The meter can be re-set only by the physician/technician. (7) Low Pressure Auto-Off Function If a major leak (e.g., when you remove the mask) is detected for a period of time, the airflow will decrease to a low pressure and the screen will display [LOW PRES], after approximately two minutes the device will automatically turn off and go back to standby mode. To re-start the treatment, simply press the "START/STANDBY" button.

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Flowchart of Menu settings Enter the user's menu mode by pressing the “MENU” button.

In each setting, when the preferred value has been selected, press "MENU" for confirmation and press "MENU" again to enter next selection.

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5. Cleaning & Maintenance 5.1 Device The device should be checked and dusted regularly (at least every 30 days). Wipe with a damp cloth and a mild detergent and keep it free from dust. If other detergent is used, choose one that will have no chemical effects on the surface of the plastic case. All parts should be air-dried thoroughly before use. WARNING: Don’t try to open this device. Repairs and internal servicing should only performed by an authorized service agent. Don’t drop any subject into the air tube or air outlet. 5.2 Tubing and Mask The tubing and mask should be checked and cleaned daily. Please refer to the cleaning instruction packaged with the accessories. 1. Disconnect the air tubing from the air outlet of the device. 2. Remove the air tubing and headgear straps from the nasal mask. 3. Use a mild detergent and prepare the detergent according to manufacturer's recommendations. Tubing and mask can be washed and rinsed in warm water. 4. Rinse thoroughly and make sure they are completely dry before next use. 5. All items of the mask and air tubing are subject to normal wear and tear and may eventually be replaced. Replace the mask and the air tubing if they are damaged. WARNING: Do not use any cleaner containing fragrance or conditioners as they will leave a residue. WARNING: The mask must not be re-used by another person. This is to avoid the risk of cross-infection. 5.3 Air Filter The air filter should be checked and replaced every 30 days, or more often if this device is operated in a dusty environment.

1. Open the air filter cover on the back of the unit. 2. Remove the dirty filter. 3. Insert a new filter. 4. Place the filter cover back.

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6. Troubleshooting The table below lists troubleshooting solutions for the problems that may happen. If the problem persists, contact your equipment provider service agent. Problem No display

Display code incorrect Illumination under LCD is not on Buttons disable Air delivered is slow

Probable Cause

Solution

1. Ensure the power cord is connected. 1. The power cord is not connected to the power 2. Contact your equipment provider. socket. 2. LCD failure or controlled PCB failure. LCD failure or controlled Contact your equipment provider. PCB failure. LED failure Contact your equipment provider. Button failure

Contact your equipment provider.

1. During ramp time. 2. Filter is too dirty. 3. Flow generator failure.

1. Check the ramp time setting 2. Change or clean the filter regularly. 3. Contact your equipment provider.

Error Messages Description– Message type Error – Primary function can not be executed.

Warning

Definition Error for abnormal system settings Error for flow generator failure Error for abnormal timer setting or timer failure Out of system memory System memory is nearly full

Message on LCD E

001

E

002

E

003

WARN 001 WARN 002

NOTE – When the warning message appears, contact your equipment provider to download the memory data and reset the meter.

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7. Technical Specifications Item Power Supply Therapy Pressure Ramp Time Ramp Starting Pressure Dimensions (W x D x H) Weight Sound Level Temperature

Specifications Universal power supply, 100-240 VAC, 50/60 Hz, 1A 4 –18 cmH2O (adjustable in 0.5 cmH2O increment) 0 – 45 minutes (adjustable in 5-minute increment) 3 – 17 cmH2O (adjustable in 0.5 cmH2O increment) 17.1 x 25.3 x 11 cm or 6.7” x 9.96” x 4.3” 2 kg or 4.4 lb Under 30 dBA at 10 cmH2O, 1 meter distance Operating: +5°C to +35°C (+41°F to +95°F) Storage: -15°C to 50°C (+5°F to +122°F) Environment Shipping: -15°C to 70°C (+5°F to +158°F) Humidity Operating: 15% RH to 95% RH non-condensing Storage: 10% RH to 90% RH non-condensing Air Tubing Flexible plastic, 1.8 m (approx.) IEC 60601-1/UL60601-1 Class I, Type BF, IPX0 EN 60601-1-2 Applied Parts Nasal Mask Classification: Not suitable for use in the presence of a flammable anaesthetic mixture (No AP/APG Protection) Continuous operation. NOTE - the manufacturer reserves the right to modify the specification without notice.

BF symbol, which indicates this product is according to the degree of protecting against electric shock for type BF equipment. Attention, should read the instructions. Grounding terminal Disposal of Electrical & Electronic Equipment (WEEE): This product should be handed over to an applicable collection point for the recycling of electrical and electronic equipment. For more detailed information about the recycling of this product, please contact your local city office, household waste disposal service or the retail store where you purchased this product.

8. NOTE, CAUTION, AND WARNING STATEMENTS NOTE: Indicate information that you should pay special attention to. CAUTION: Indicate correct operating or maintenance procedures in order to prevent damage to or destruction of the equipment or other property. WARNING: Calls attention to a potential danger that requires correct procedures or practices in order to prevent personal injury. 13

AUSTRALIAN AND NEW ZEALAND DISTRIBUTOR: WORD-MEDEX PTY LTD PO Box 1436, Lane Cove, NSW 1595, AUSTRALIA Phone: 1-300-764-498 or +61 2 9420-1240 Fax: +61 (02) 9427-7118 E-mail: [email protected]

EU REPRESENTATIVE: APEX MEDICAL S.L. Alameda de Recalde 50 Despacho 304 48008 Bilbao, Vizcaya, SPAIN MANUFACTURER: APEX MEDICAL CORP. 9, Min Sheng St., Tu-Cheng, Taipei County, 236, Taiwan Consult the distributor or EU representative for further technical documents 666030-0000 V1.0

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