XT Prime Model 9S-005580 Users Manual V1.8

XT Prime /English

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IMPORTANT SAFEGUARDS – PLEASE MAKE THIS PRECAUTIONS LIST AVAILABLE TO ALL USERS and PROVIDERS READ ALL INSTRUCTIONS BEFORE USING THIS SYSTEM WARNING – 1. THIS DEVICE IS NOT INTENDED FOR LIFE SUPPORT. It may stop operating due to power interruption but no hazards to patient. 2.

If oxygen is used with the device, the oxygen flow must be turned off when the device is not in use. Explanation of the Warning: When the device is not in operation and the oxygen flow is left on, oxygen delivered into the tubing may accumulate within the device’s enclosure and create a risk of fire.

3.

Oxygen supports combustion. Oxygen should not be used while smoking or in the presence of an

4.

Always ensured the device is generating airflow before the oxygen supply is turned. Always turn

5.

This device should not be used in the vicinity of a flammable anesthetic mixture in combination

open flame. off the oxygen supply before stopping the airflow from the device. with oxygen or air and nitrous oxide. 6.

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.

7.

If this device overheats, it will stop operating and show “Error 002” on the display. After cooling

8.

This machine should be used only with masks (and connectors) recommended by the

down to proper temperature, the device can restart again. 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 associated with the mask should never be blocked for proper exhaling purpose. If the vent hole is blocked, the CPAP machine will stop and show message “Error 002”, after cooling down, please re-connect the power cord to reset the machine. 9.

At low CPAP pressure, some exhaled gas may remain in the mask and be re-breathed.

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CAUTION – 1. 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. 2. If there is a possibility of electro-magnetic interference with mobile phones, please increase the distance between devices or turn off the mobile phone. 3. Do not connect the device to the personal computer for data downloading during the treatment. This may cause the CPAP system failure. 4. To prevent from potential allergic reactions to mask used in the device, This machine shall be used only with masks (and connectors) recommended by the manufacturer. 5. U.S. Federal law restricts this device to sale by or on the order of a licensed physician. DANGER -To reduce the risk of electrocution: 1. Always unplug this product immediately after using. 2. Do not use while bathing. 3. Do not place or store product where it can fall or be pulled into a tub or sink. 4. Do not place in or drop into water or other liquid. 5. 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. This product should never be left unattended when plugged in. 2. Close supervision is necessary when this product is used by, on, or near children or invalids. Choking resulting from a child swallowing a small part that has become detached from the device or its accessories. 3. Use this product only for its intended use as described in this manual, do not use attachments not recommended by the manufacturer. 4. 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 center for examination and repair. 5. Keep the cord away from heated surfaces. 6. 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. 7. Never drop or insert any object into any opening on the unit or into the tubing. 8. When disposing the unit because of damage or failure, you must comply with the regulations of your particular region or country for disposing such equipment 9. No modification of this equipment is allowed. 10. Do not modify this equipment without authorization of the manufacturer. 11. If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of the equipment. 12. Do not leave long lengths of air tubing around the top of your bed. It could twist around your head or neck while you are sleeping and lead to strangulation.

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1. Introduction This manual is provided to explain initial set up and operating instructions. This manual should be stored in a safe location and be readily accessible for future reference.

1.1 General Information Obstructive Sleep Apnea (OSA) is a condition that an intermitted and repetitive obstruction of the upper respiratory tract causes a complete (apnea) or partial (hypopnea) block of breathing airflow during sleep. The syndrome varies 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 the illuminated, menu-driven LCD display, universal power supply, and ramp time adjustment. The ramp time adjustment and ultra quiet operation ensure you to fall asleep comfortably while air pressure slowly build up to treatment level. The user compliance meter records the total system’s operating time for physician’s reference. The system has been tested and successfully approved to the following standards: IEC/EN 60601-1 IEC/EN 60601-1-2 IEC/EN 61000-3-2 Class A IEC/EN 61000-3-3 CISPR 11 Group 1, Class B

For US and CANADA only Medical Equipment - CPAP

E348970 53DG

WITH RESPECT TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601-1 (2005,3rd ed.) and CAN / CSA C22.2 No. 60601-1 (2008, 3rd ed.)

Below description is for Canada only Le produit à été testé avec des équipements médicaux et respecte les normes ANSI/AAMI ES60601-1 (2005,3rd ed.) and CAN / CSA C22.2 No. 60601-1 (2008). prévenant les choc électrique, le feu et les risques de blessures physiques.

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EMC Warning Statement This equipment has been tested and found to comply with the limits for medical devices to the IEC/EN 60601-1-2. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:  Reorient or relocate the receiving device.  Increase the separation between the equipment.  Connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected.  Consult the manufacturer or field service technician for help.

1.2 Intended Use This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult Obstructive Sleep Apnea (OSA). Cautions:

Some patients might have pre-existing contraindications for CPAP therapy, or might experience some potential side effects of using CPAP device, please consult your physician if you have any questions concerning your therapy.

1.3 Contraindications Studies have shown that the following pre-existing conditions may contraindicate the use of CPAP therapy for some patients.

Should you have any of these conditions, your physician will

determine if CPAP therapy is appropriate for you.  Bullous lung disease  Pneumothorax  Pathologically low blood pressure due to or associated with intravascular volume depletion  Severe cardiac arrhythmias or coronary artery disease  Stroke  Seizures  Pneumocephalus has been reported in a patient using nasal Continuous Airway pressure

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2. Product Description Components including: (1)

Main CPAP device

(2)

Detachable power cord

(3)

User manual

(4)

Flexible air tubing with 1.8 m length

(5)

Carrying bag

(6)

SD card and USB cable Note 1: ONLY for Physician or Technician to download data. Patient should not use this unction. Note 2: Only applicable for devices with SD card slot. Note 3: Please use SD card (smaller than 4GB) which comply with SDHC standard.

Before

using it, please format it to FAT16 to ensure correct data collection. CAUTION - Patient should not connect the device to the personal computer for data downloading. This may cause the CPAP system failure.

Menu Button Start/Standby Button LCD Display

Up Button Down Button

Air Outlet

Air Filter

SD Card Slot / Mini-USB Connector Power Socket

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3. Installation 3.1 Unpacking To secure its contents inside, the CPAP device and accessories are bundled in a paper packaged box. Unpack this box by removing the CPAP and its accessory and checking for any damage, which may have occurred during shipping. If there are damages, please contact your dealer immediately.

3.2 Setting Up 1) Connect the power cord to CPAP device and plug into main electrical outlet. Once the power cord is plugged into the electrical outlet, the device is in ready to operate position (“STANDBY” sign appears in LCD display)

NOTE:

The plug is also served to disconnect the device.

2) Connect one end of the air tubing firmly to the air outlet of the CPAP.

3) Connect the other end of the air tubing to the mask system. Putting on the mask and headgear according to the mask instruction manual.

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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 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 Therapy Pressure [ XX.X cmH2O] in cmH2O unit. MENU Press the "MENU" button to enter the setting mode when device is in standby mode. The adjustment setting includes mode selection, ramp time selection, ramp starting pressure, therapy pressure adjustment, alarm ON/OFF, clock alarm and clock setting, compliance meter, and total operating meter. When each setting's value 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 increase the value.

DOWN Press the "DOWN" button to decrease the value.

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4.2 Function Description Getting Started – First time use. For first-time use, follow the steps below: 1. Make sure that your physician or care provider has initialized and configured the appropriate treatment values into the unit. 2. Make sure that your package contains a face or nasal mask with headgear. If not, your physician or care provider can recommend the type of mask and headgear you must obtain 3. Attach tubing and mask (see Setup section). 4. Attach power cord to the unit and an electrical outlet (see Setup section). Unit will power-on automatically. 5. Use the “MENU” button to set the Current Time, Ramp Up Time, and Ramp Starting Pressure, (see “MENU” Button Section for description of these options). Note that these values may have been already set by your physician or care provider. 6. Press the “START/STANDBY” button – Airflow to the mask will begin. 7. You can now place the Headgear and Mask over your head and face and begin treatment

4.3 Menu Button - Option Descriptions The following items describe the options presented to you after you press the “MENU” button on the control panel. (1)

Ramp Time Ramp time function allows user to fall into sleep with a lower, comfortable pressure and helps users gradually get accustomed to increasing treatment pressure. The first selection of pressing "MENU" is [Ramp XX MIN]. When the "MENU" setting is in [Ramp XX MIN] mode, press "UP" or "DOWN" button to set the preferred ramp time and press "MENU" for confirmation. There are 10 adjustable levels, 0, 5, 10, 15, 20, 25, 30, 35, 40 and 45 minutes.

(2)

Ramp Starting Pressure Press "MENU" button to select [Ramp P XX.X] menu, press "UP" or "DOWN" button to set the preferred ramp starting pressure and press "MENU" for confirmation. The ramp starting pressure can be changed from 4 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.

(3)

Therapy Pressure XX.XcmH2O] menu. You can view the current Press "MENU" button to select the [P pressure setting displayed in cmH2O unit. Therapy pressure is adjustable only by the provider, a respiratory therapist or doctor. NOTE: The therapy pressure is to only be prescribed by a physician.

(4)

PVA (Pressure Variation Algorithm) on/off] menu, you can view if the PVA function is Press "MENU" button to select [c enabled by the provider, a respiratory therapist or physician. The PVA function delivers pressure relief upon exhalation to improve comfort. If the PVA function is enabled, press "UP" or "DOWN" button to adjust the comfort level. There are 3 adjustable levels of pressure relief that you feel while exhalation. Level 1 provides small pressure variation; and level 3

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provides higher pressure variation. (5)

Low Pressure Auto Off Press "MENU" button to select [LOW P on/off] menu, you can view if the Low Pressure Auto Off setting is enabled and the device will be automatically turned off while detecting a large leak for 3 minutes. This setting is adjustable only by the provider, a respiratory therapist or physician.

(6)

Compliance Meter Press "MENU" button to select the [CM XXXX.X hr] menu. The compliance meter records the total therapy hours for the device. The compliance meter should be re-set only by the provider, a respiratory therapist or by a doctor.

(7)

Alarm Press "MENU" button to select the [Alarm on/off] menu, and press "UP" or "DOWN" button to set the alarm on or off. When the alarm is turned on, the audible alarm will activate with warning messages shown on the LCD display. Set alarm off to mute the audible alarm.

(8)

Clock Alarm Press "MENU" button to select the [Clock Alarm on/off] menu and press "UP" or "DOWN" button to set the clock alarm on or off. When the clock alarm is set on, the display will show the time on the left side. Press "UP" or "DOWN" button to set the time to wake you up. Once the clock alarm is activated, press the start/standby button to mute the audible alarm.

(9)

Clock Press "MENU" button to select the [Clock XX:XX] menu, press "UP" or "DOWN" button to set the current time.

(10) Turning off the Device Remove the power cord from the electrical outlet, and disconnect power cord from the power socket on the right side of the device. Once the setting is confirmed, press the “MENU” button. Otherwise, the device will automatically go back to standby without saving the modification if no action is taken in 20 seconds. (11) Event Indication While the device is on standby mode, press UP" and "DOWN" button at the same time to see the latest one data of Apnea Index (AI), Hypopnea Index (HI) and Snoring Index (SI) on the display. Press "MENU" button to show each index in sequence. To go back to standby mode, press "START/STANDBY" button. NOTE:

NOTE:

AI, HI, SI indexes of the last sleep session with over 15 minutes of usage is displayed. Index data can be viewed by respiratory therapists or physicians by using Easy Compliance playback software.

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4.4 Flowchart of Menu settings Enter the user's menu mode by pressing the “MENU” button. Ramp (Ramp Time)

< 0, 5, 10, 15, ……………., 45> min

Ramp P (Ramp Starting Pressure)

< 4, 4.5,5,5.5, ……………., 19> cmH2O

P (Therapy Pressure)

< 4, 4.5, 5, 5.5, ……………., 20> cmH2O

C (PVA Comfort Level)

PVA <On>

<0, 1, 2, 3>

Low P

(Low Pressure Shut Off)

< on/off >

CM (Compliance Meter)

< XXXX.X > hr

Alarm

Clock Alarm

Clock

< on/off >

Clock Alarm <On>

< hh: mm >

< hh: mm >

In each setting, when the preferred value has been selected, press “MENU” for confirmation and press “MENU” again to enter next selection. NOTE: For physicians, please refer to a separated “Physician’s Additional Instruction” page.

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5. Adding a Humidifier XT Prime CPAP device can be used with XT Heated Humidifier (9S-006500) which is available from the home care provider. The heated humidifier may reduce nasal dryness and irritation by providing adequate moisture and heat to the airflow. Please refer to the XT heated humidifier (9S-006500) instruction manual for complete setup information. NOTE: When XT Prime CPAP device is used with the heated humidifier, its power supply is from the power socket outlet of the heated humidifier. Do not connect the power cord to CPAP device and plug into main electrical outlet.

6. Using the SD Card to Collect Data If physicians need to review the usage data, they may ask you to use the SD card to copy data from the device, and to return the card to them. Data that is copied to the SD Card is still stored and available on the device. 1. Insert the SD Card when the device is in standby mode. 2. Data copying starts automatically when the SD Card is inserted into the slot. 3. The [COPY] & [Card] messages are displayed on the LCD while data is being copied. 4. The [End] & [OK] messages are displayed on the LCD when copying has finished. 5. Remove the SD Card and mail it to the clinician. 6. The SD card does not need to be uninstalled for the device to work properly. CAUTION:

Do not remove the SD card until [End] & [OK] messages are displayed on the LCD, or data copied to the card may be corrupted or missing.

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7. Cleaning & Maintenance 7.1 Cleaning the Main Unit The main unit should be cleaned regularly (at least every 30 days). To clean the unit, wipe it down with a damp cloth using a mild detergent. When selecting a cleaning agent, take precautions to choose one that is not chemically abrasive to the surface of the plastic case. All parts should be air-dried thoroughly before use. During storage, the unit should be kept in a dust-free location. 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.

7.2 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.

Wash the mask system according to the instructions supplied with it. Wash the air tubing in

4.

Rinsed thoroughly, hang and allow to dry.

5.

Before next use, assemble the mask and headgear according to the mask user instructions.

6.

All items of the mask and air tubing are subject to normal wear and tear and may eventually

warm water using mild detergent.

be replaced. Replace the mask and the air tubing if they are damaged. CAUTION:

Do not use blench, chlorine-, alcohol-, or aromatic-based (including all scented oils), moisturizing or antibacterial soaps to clean the cushion, mask, air tubing. These solutions may cause hardening and reduce the life of the product.

CAUTION:

Do not wash or dry the mask or air tubing at a temperature above 70°C (158°F)

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.

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7.3 Air Filter Maintenance For an optimum operation of the device, the air filter can be cleaned by the user at least once every two weeks or more often if this device is operated in a dusty environment. It is recommended that the filter be replaced with a new one after 6 months of use; however, depending on the air quality, the replacement time may vary. CAUTION:

Dirty air filter may cause high operating temperatures that affect device performance. Ensure the air filter is cleaned and fitted at all times. 1. 2.

3.

Remove the dirty filter from the enclosure on the rear of the device. Wash the filter in warm water with a mild detergent, and rinse with water. Allow the filter to air dry completely before reinstalling. Do not use a filter that is not completely dry. If the filter is torn, replace it. Reinstall the filter.

NOTE: Please follow national requirements to dispose the unit properly.

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8. 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

Possible Causes 1.

The power cord is not

Solutions 1.

Ensure the power cord is

2.

Contact your equipment provider

connected to the power socket. 2.

connected.

LCD failure or controlled PCB

for repair.

failure. Display code incorrect

LCD failure or controlled PCB failure. Contact your equipment provider for repair.

Illuminant under LCD is not LED failure on

Contact your equipment provider for repair.

Buttons disable

Button failure

Contact your equipment provider for

Air delivered is slow

1.

During ramp time.

1.

Check the ramp time setting

2.

Filter is too dirty.

2.

Change or clean the filter

3.

Flow generator failure. 3.

Contact your equipment provider

repair.

Data can not be copied to the SD card

1. SD card is full. 2. SD card is not inserted correctly. 3. Data on the SD card is corrupted.

regularly. for repair. 1. Ensure the SD card has enough capacity. 2. Ensure the SD card is inserted into the slot. 3. Format the card.

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Error / Warning Messages show in LCD. Message type Error: Primary function can’t execute.

Warning:

NOTE:

Definition

Message in LCD

Error for abnormal system settings

Error

001

Error for flow generator failure

Error

002

Error for abnormal timer setting or timer failure

Error

003

Error for flow sensor failure

Error

004

Out of system memory

Warn

001

System memory is nearly full

Warn

002

SD card module communication failure

Warn

003

Remove the SD card while data is being processed

Warn

004

SD card is full

Warn

005

Inconsistent ID no. of device with SD card

Warn

006

Wrong firmware version of SD card module

Warn

007

SD card is damaged

Warn

008

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

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9. Technical Specifications Item

Specifications

Power Supply

Universal power supply, AC100-240V, 50/60 Hz, 0.5-0.3A

Pressure Range

4-20 cmH2O (adjustable in 0.5 cmH2O increment)

Ramp Time

0-45 minutes (adjustable in 5-minute increment)

Ramp Starting Pressure

4-19 cmH2O (adjustable in 0.5 cmH2O increment)

Operating Altitude

up to 8,000 ft (2,438 m) when the pressure is set at 4-18 cmH2O but limit to 5,000ft (1,524m) when the pressure is set at 18.5 20 cmH2O

Dimensions (W x D x H)

14.5 x 13.0 x 10.0 cm or 5.7” x 5.1” x 3.9”

Weight

Approximately 800 g or 1.76 lb Temperature

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 Shipping: 10%RH to 90%RH non-condensing Class II Type BF, Applied Parts: Mask Not suitable for use in the presence of a flammable anesthetic

Classification:

mixture IP21: Protected against solid foreign objects of 12.5 mm and greater; Protected against vertically falling water drops. Continuous operation.

Note: The manufacturer reserves the right to modify the specification without notice.

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Symbols BF symbol, which indicated this product, is according to the degree of protecting against electric shock for type BF equipment.

Attention, should read the instructions.

Refer to instruction manual

Class II

Attention, should read the instructions.

Protected against solid foreign objects of 12.5 mm and greater; Protected against vertically falling water drops. 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. Authorized representative in the European community

Manufacturer

RTCA/DO-160 Section 21 Category M Compliant

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10. 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.

11. Servicing The XT series systems are intended to provide safe and reliable operation according to the instructions provided by Apex Medical. Apex Medical recommends that the XT system be inspected and serviced by authorized technicians if there is any sign of wear or concern with device function. Otherwise, service and inspection of the devices generally should not be required during the five year design life of the device.

12. Limited Warranty Apex Medical Corp. (hereafter ‘Apex’) gives the customer a limited manufacturer warranty on new original Apex products and any replacement part fitted by Apex in accordance with the warranty conditions applicable to the product in question and in accordance with the warranty periods from date of purchase as listed below. This warranty does not cover damage caused by accident, misuse, abuse, alteration and other defects not related to material or workmanship. To exercise your rights under this warranty, please contact your local, authorized Apex dealer. Product

Warranty period

CPAP devices

2 years

Water chamber

6 months

Mask systems

6 months

Disposable products

None

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Appendix A: EMC Information Guidance and Manufacturer’s Declaration- Electromagnetic Emissions: This device is intended for use in the electromagnetic environment specified below. The user of this device should make sure it is used in such an environment. Emissions Test

Compliance

RF emissions CISPR 11

Group1

RF emissions Class B CISPR 11 Harmonic emissions Class A IEC61000-3-2 Voltage fluctuations / Complies Flicker emissions IEC61000-3-3

Electromagnetic Environment-Guidance The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment

The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network

Warning: 1. The device should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the device should be observed to verify normal operation in the configuration in which it will be used. 2.Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. 3. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the CPAP, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Guidance and Manufacturer’s Declaration- Electromagnetic Immunity: This device is intended for use in the electromagnetic environment specified below. The user of this device should make sure it is used in such an environment. Basic EMC standard

Electrostatic Discharge (ESD) IEC61000-4-2

Electrical fast transient/ burst IEC61000-4-4

Immunity Test Levels Compliance Levels

Electromagnetic Environment-Guidance

±8kV contact ±15kV air

±8kV contact ±15kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

±2kV for power supply line ±1kV for input/output line

±2kV for power supply line ±1kV for input/output line

Mains power quality should be that of atypical commercial or hospital environment

Professional HOME healthcare HEALTHCARE facility environment ENVIRONMENT