XT Model 9S-006500 Heated Humidifier Users Manual V1.5

CONTENTS USER’S MANUAL

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MANUAL DE INSTRUCCIONES

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INSTRUCTIONS D'UTILISATION

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MODEL NO.: 9S-006500 PLEASE READ THE MANUAL BEFORE USE

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IMPORTANT SAFEGUARDS – PLEASE MAKE THIS PRECAUTIONS LIST AVAILABLE TO ALL USERS and PROVIDERS READ ALL INSTRUCTIONS BEFORE USING THIS SYSTEM DANGER – Reducing the risk of electrocution:  Always unplug this product immediately after using.  Do not use while bathing.  Do not place or store product where it can fall into or be pulled into a tub or sink.  Do not place in or immerse into water or other liquids.  Do not reach for the unit if it is immersed in water or other liquids. Unplug the unit immediately. WARNING – Reducing the risk of burns, electrocution, fire, or personal injury.  Do not operate CPAP (Continuous Positive Airway Pressure, which is used for Obstructive Sleep Apnea treatment) before mask and humidifier is installed.  Disconnect the humidifier from CPAP unit when not in use. Water entering the CPAP unit may result in electrical hazard (shock) or damage to the CPAP unit.  Do not use if water comes in contact with the CPAP unit or enters the tubing.  XT Heated Humidifier (9S-006) is not for use with patients whose supraglottic airways have been bypassed.  Do not use the XT Heated Humidifier (9S-006) on the floor.  The docking platform of the XT Heated Humidifier is only intended for the 9S-005 (XT) series CPAP. If used with other devices, you may encounter potential electrical hazards (shock) or damage to the XT Heated Humidifier unit.  Do not cover the humidifier with blankets, clothes or other material.  Do not remove the water chamber while the humidifier is on and heating the chamber.

Do not touch the

heating plate for 30 minutes after the device is disconnected from the electrical socket.  This product should never be left unattended when plugged in.  Close supervision is necessary when this product is used by, on or near children or individuals. Choking resulting from a child swallowing a small part that has become detached from the device or its accessories.  Use this product only for its intended use as described in this manual. Use this product only under a physician’s supervision. Do not use the equipment with accessories other than those supplied with this unit. Contact your local dealer/EU representative for additional information.  Never operate this product if a) it has a damaged cord or plug, b) it is not operating properly, c) it has been dropped or otherwise traumatized, d) it has been immersed into water. Return the product to a qualified service center, distributor or EU representative for examination and repair.  Keep the cord away from heated surfaces.  Never block the air openings of this product or allow objects to fall or be inserted into the air vent openings.

Do not place unit on soft surfaces such as beds or couches, where the air openings may

become obstructed.  This device IS NOT to be used if the room temperature is warmer than 35℃(95℉) to prevent the temperature of air delivered to nasal mask from exceeding 41℃(104℉).

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 No modification of this equipment is allowed.  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. CAUTION –  Use humidifier accompanied with XT series CPAP system and CE certified or 510(k) cleared accessories  If there is a possibility of electro-magnetic interference with mobile phones, please increase the distance (3.3m) between devices or turn off the mobile phone.

NOTE – U.S. Federal law restricts this device to sale by, or on the order of, a licensed physician.

NOTES, PRECAUTIONS AND WARNINGS DANGER:

Indicates an extreme and immediate hazardous situation which can result in death or serious injury if not avoided.

WARNING:

Warning indicates a potential hazardous situation which will result in death or serour injury if not avoided.

CAUTION:

Caution indicates a potentional hazardous situation which will result in property damage or destruction of equipment if not avoided.

NOTE:

Note indicates some tips that user should pay attention to.

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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 Attention, should read the instructions. Class II 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. Fill line Air flow direction Authorized representative in the European community Manufacturer

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1. Introduction This manual is provided to explain initial set up and operating instructions.

1.1 General Information This system has been tested and successfully approved by the following standards. EN60601-1 EN60601-1-2

0197

EN 61000-3-2 Class A EN 61000-3-3 CISPR 11 Group 1, Class B

For US and CANADA only Medical Equipment- Heated Humidifier WITH RESPECT TO ELECTRICAL SHOCK, E348970 FIRE AND MECHANICAL HAZARDS ONLY 53DG IN ACCORDANCE WITH ANSI/AAMI ES60601-1 (2005,3rd ed.) and CAN / CSA C22.2 No. 60601-1 (2008, 3rd ed.) and IEC 60601-1-11 1 Le produit à été testé avec des équipements médicaux et respecte les normes ANSI/AAMI rd ES60601-1 (2005,3rd ed.) and CAN / CSA C22.2 No. 60601-1 (2008, 3 ed.) and IEC 60601-1-11. prévenant les choc électrique, le feu et les risques de blessures physiques.

EMC Warning Statement This equipment has been tested and found to comply with the limits for medical devices for EN 60601-1-2. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This unit 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 unit. - Increase the distance between the conflicting equipment. - Connect the unit into an outlet that is on a different circuit than the other device(s). - Consult the manufacturer or field service technician for help.

1.2 Intended use XT Heated Humidifier is intended for use with the XT series CPAP unit. It has been designed to increase the moisture of the air delivered from the CPAP, relieving symptoms of a dry nose and throat that some people may experience. NOTE: This equipment is not suitable for use in the presence of a flammable anesthetic mixture with oxygen and/or nitrous oxide.

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2. Product description Silicon Connector Baffler

Flow Direction

Outlet Port

Inlet Port

Water Chamber Removable Base Plate Locking Tab Fill Line

Power Jumper Heater Platform Power Switch

Extraction Tool

Cord AC Power Cord

Power Socket (Inlet) Heater ON Indicator Heater Plate Switch Heater Plate

Water Chamber: Fill Line: Flow Direction Indicator: Indicator Baffler: Extraction Baffler: Heater Plate: Locking Tab: Heater Plate Switch: Control Knob: Heater On Indicator (Green LED): Abnormal Indicator (Orange LED): Inlet Port with Silicon Ring: Outlet port: AC Power Cord: Power Socket (Inlet): Power Jumper Cord: Power Switch:

Control Knob Abnormal Indicator

The water chamber contains the water for humidification. Its removalble base plate allows itself ease for cleaning. Symbol indicates the maximum level of water that water chamber can contain. Symbol indicates the air flow direction. The baffler can prevent water spillage due to improper shaking. Open the water chamber for cleaning. Warms the water in the water chamber. Hold the CPAP in place. When the switch is pressed against the water chamber, the heater plate will start to work. This control knob, graduated from 1 to 6, is used to adjust the humidity. 1 is minimum humidify, 6 is maximum humidity. When lit, this indicates that the heater is turned on. When lit, this indicates that the fuse blows off. Connect to the outlet port of the CPAP device. Connect to the outlet port of the CPAP device. Connects to an AC outlet providing main power to the heated humidifier. Connect to the AC power cord here. Connect the heated humidifier and the CPAP device. Turn the heated humidifier ON and OFF.

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3. Installation 3.1 Set Up 1. Place the CPAP device onto the humidifier platform so that the four rubber knobs on the bottom of the CPAP device align with the four matching indentations on the platform. Also make sure that the Locking Tab fits squarely into the slot in the rear of the CPAP unit (beneath the power socket). This will keep the CPAP device in place on top of the humidifier.

2. Place the CPAP with humidifier onto a flat surface. This surface should be lower than the level at which you will be sleeping.

3. Connect the power jumper cord to the AC inlet on the back of the CPAP device.

4. Connect the AC power cord to the power socket (inlet) on the back of the humidifier, and plug it into a main outlet. NOTE:

1. Make sure the heated humidifier unit is suitable for the local power voltage. 2. The plug also can serve to disconnect the device. Do not position the equipment so that it is difficult to operate the disconnecting device.

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4. Operation 4.1 Operating instruction Daily Use

Silicon Ring

1.

Turn on the humidifier by pressing the On/Off switch on the back of the humidifier platform. The humidifier power-on indicator will illuminate (green light).

2.

Fill the chamber to the fill line distilled water (approx. 450 ml).

3.

Place the chamber on the edge of the heater plate. Press down on the chamber (the heater plate will give). Slide the edges on both sides of the base of the chamber into guides on both sides of the heater plate bay. Continue to slide the chamber into place until the two air ports from the humidifier and CPAP meet and the chamber is secure against the heat plate bay of the humidifier.

4.

Note: Make sure the water chamber is pressed up against the heater plate switch. At this time, the heater-on indicator will be lit to indicate the heater plate is on.

Heater Plate Switch

with

Note: The heater will be automatically turned off when the water chamber is removed from the heater plate.

5.

Connect the flexible tubing to the outlet connector on the water chamber.

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6.

Connect the other end of the flexible tubing to your mask.

7.

Adjust the heater temperature to the desired setting by using the control knob. 1 is minimum humidity, 6 is maximum humidity. The optimum setting is dependent on the ambient temperature and humidity of your room.

The Heated Humidifier and CPAP device is now ready for use. Consult the CPAP user’s manual for the CPAP operating instructions. Danger:

In order to avoid damages to the CPAP equipment and prevent hazards from electric shock, DO NOT pour water into the outlet port of the water chamber while the water chamber is installed onto the humidifier.

Also remember not to exceed the high water

mark (Fill Line) with water when filling the chamber with water.

5. Cleaning 5.1 Cleaning the Heater 1. Clean the humidifier by wiping it down with a damp cloth. Allow the heater to air dry before connecting the power cords. 2. Inspect the humidifier and power cord for any damage and replace them if necessary.

5.2 Cleaning the Water Chamber 1. Turn the humidifier off and allow the heater plate and water to cool. 2. Disconnect the flexible tubing from the water chamber. Press down on the water chamber and slide it off of the heater plate. Empty the remaining water. 3. Use the extraction tool to disengage the chamber base. The extraction tool will be tucked into a recessed indentation on top of the humidifier platform. Match the notch on the front right corner of the Plastic Chamber with the inverted notch on the extraction tool so that the side of the tool is flush against the side of the chamber base. Lever the extraction tool to pry the base gently from the chamber. 4. Use a mild detergent to wash the chamber and base. Rinse all the parts with clean water and allow each part to air dry individually. 5. All items of the chamber are subject to normal wear and tear and may eventually need replacement. Replace the chamber parts if any damage is present.

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6. Troubleshooting The table below lists troubleshooting solutions for the problems that may happen. If problems persists, contact your equipment provider service agent immediately. Problem

Possible Causes

Heater on indicator not 1. Heater plate over heated light at all 2. PCB indicator worn out Abnormal indicator lights 1. The fuse blows off

Solutions 1. Contact your local agent or EU representative for service. 1. Contact your local agent or EU representative for service.

1. CPAP device is not turned on or 2. Refer to your CPAP user manual. working correctly. There is no air flow 3. Reconnect the flexible tubing. 2. Flexible tubing is not connected through the mask 4. Remove obstruction from the correctly. flexible tubing. 3. Flexible tubing is obstructed. 1. The heater plate setting is too 1. Adjust the control knob to lower the temperature setting. high. Condensation in mask or 2. The ambient room temperature 2. Remove any air conditioner which may be in the vicinity of the flexible tubing. is too cold, causing the warm heated humidifier. Or keep room humidified air in the mask to temperature close to 25℃。 condense into droplets. 1. Remove the water chamber from the heater and discard all water. Remove base plate from the 1. Assembly of water chamber is Water Chamber. Make sure the removable base plate is secured incorrect. Water Leakage 2. Water chamber or removable into the base of the water chamber. Fill chamber with water base plate worn out. until it reaches the fill line and recheck for leakage. 2. Replace the water chamber.

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7. Technical Description Item

Specification

Model No.:

9S-006500

Power Requirement:

AC100-240V, 50/60Hz, 0.6-1.2A

Fuse Rating:

T2A, 250 VAC

Dimensions: Weight (without Water): Water Capacity: Maximum Heater Plate Temperature: Pressure Drop: Humidity Output:

Heater: 25.5 x 17.5 x 5 cm (10” x 6.9” x 1.97”) Water Chamber: 13.6 x 15 x 10.5 cm (5.36” x 5.91” x 4.14”) Heater: under 600g (1.32 lbs) Water Chamber: under 250g (0.55 lbs) 450ml Approximate 70°C (158°F) 0.2cm H2O @ 60LPM ≥10 mgH2O/L (ambient temperature of 23°C ± 2°C, ambient relative of humidity 60% ± 15%) Temperature: 5°C-35°C

Operating Environment

Humidity: 15%-95%RH Atmospheric Pressure: 609-768mmHg Temperature: -15°C-50°C

Storage Environment

Humidity: 10%-90%RH Atmospheric Pressure: 609-768mmHg Class II Type BF, Applied Parts Nasal Mask

Classification

Not suitable for use in the presence of a flammable anesthetic mixture IP21: Protected against solid foreign objects of 12.5 mm and greater; Protected against vertically falling water drops. Continuous operation.

NOTE: 1. These specifications are also suitable for other regions operating with same power supply. 2. Consult the distributor or EU representative for other technical documents.

8 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.

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9 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 (including external power supply units)

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

Electromagnetic Environment-Guidance

RF emissions CISPR 11

Group1

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

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

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 device, 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. Immunity Test Levels Basic EMC standard

Electrostatic Discharge (ESD) IEC61000-4-2

Electrical fast transient/ burst IEC61000-4-4

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 Mains power quality should be that of atypical commercial or ±1kV for hospital environment input/output line

Professional HOME healthcare HEALTHCARE facility environment ENVIRONMENT

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Surge IEC61000-4-5

± 1 kV line(s) to line(s) ± 2 kV line(s) to earth

13 ± 1 kV line(s) to line(s)

± 1 kV line(s) to Mains power quality should be line(s) that of atypical commercial or hospital environment.

Voltage dips, Voltage Dips: short i) 100% reduction for 0.5 period, interruptions and ii) 100% reduction for 1 period, voltage variations iii) 30% reduction for 25/30 period, on power supply Voltage Interruptions: input lines 100% reduction for 250/300 period IEC61000-4-11

100 - 240 V

Power frequency (50/60Hz) magnetic field IEC61000-4-8

30 A/m

Conducted RF IEC 61000-4-6

Radiated RF EM Fields IEC61000-4-3

30 A/m

30 A/m

3 Vrms 3 Vrms 0,15 MHz – 80 0,15 MHz – 80 MHz MHz 6 Vrms in ISM bands 6 Vrms in ISM and 6Vrms between 0,15 MHz amateur radio and 80 MHz bands between 80 % AM at 1 kHz 0,15 MHz and 80 MHz 80 % AM at 1 kHz

3 V/m 80 MHz to 2.7 GHz 80 % AM at 1 kHz

10 V/m 80 MHz to 2,7 GHz 80 % AM at 1 kHz

385-6000 MHz, 9-28V/m, 80% AM(1kHz) pulse mode and other modulation

385-6000 MHz, 9-28V/m, 80% AM(1kHz) pulse mode and other modulation

Mains power quality should be that of a typical commercial or hospital environment. If the user of this device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply or a battery. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Portable and mobile RF communications equipment should be used no closer to any part of this device, including cables, than there commended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 150kHz to 80MHz 80MHz to 800MHz d =0.6 800 MHz to 2.7GHz d =1.2 Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).b

10V/m

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey ,a should be less than the compliance level in each frequency ranged. Interference may occur in the vicinity of equipment marked with the following symbol:

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NOTE 1: UT is the a.c. mains voltage prior to the application of the test level NOTE 2: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 3: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people a)Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device. b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m. Recommended separation distances between portable and mobile RF communications equipment and this device: This device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of this device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and this device as recommended below, according to the maximum output power of the communications equipment. Rated maximum Separation distance according to frequency of transmitter m output power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7 GHz W d= d =0.6 d =1.2 0.01 0.1 0.06 0.12 0.1 0.31 0.19 0.38 1 1 0.6 1.2 10 3.1 1.9 3.8 100 10 6 12 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

USA Apex Medical USA Corp. 927 Mariner Street, Brea, CA 92821, USA

Apex Medical S.L. Elcano 9, 6a planta 48008 Bilbao. Vizcaya. Spain

Apex Medical Corp. No.9, Min Sheng St., Tu-Cheng, New Taipei City, 23679, Taiwan www.apexmedicalcorp.com Print-2017/All rights reserved 676029-0000 V1.5