Drive Medical Celestia 18250 Instruction Manual

Celestia

CPAP with Heated Humidifier

Instruction Manual

Model No.: 18250 Please read the instruction m anual before use.

Contents

Important Safeguards…………………..…………….….… . ….1

1.Introduction………………………… ..........………………. 3

2. Product Description……………….…...…………….…..4

3. Installation.………………………………….…...….…….6

4. Operation ……………….............................…………..9

5. Cleaning & Maintenance……………………….. . …………13

6. Troubleshooting ……….…..…….…………….………...15

7. Techn ical Specification .………..…….….………..……… 17

8. Note, Caution and Warn ing Statements……………….…. 18
APPENDIX A: EMC Information……………………………20

IMPORTANT SAFEGUARDS

SAVE THESE INSTRUCTIONS

RE AD AL L INSTRUCTIONS BEFORE USING

WARNING –

1. THIS DEVICE IS NOT INTENDED FOR LIFE SUPPORT. It may stop operating due to power

interrupti on but no hazards to patient.

2. This device should n ot be used with oxygen.

3. This device should not be us ed in the vicinity of a flammable an esthetic mixture in combination with

oxygen or air and nitrous oxide.

4. The airflow fo r b r e a thing gene r a t ed by this device may be as much as 7°C (12 .6°F) higher than the room
temperature. This device SHOULD NOT be us ed if the r o o m tem p eratu re is warm er than 3 5 °C (95 °F) to
prevent the airflow temperature from exceeding 40°C (104°F) and causing irritation to your airway.

5. If this device overh eats, it w ill stop operatin g and show “Err or Me ssage 0 02” on th e display. Af ter
cooling dow n to prop er temperature, the device can restart again.

6. This machine should be us ed only with masks (and connectors) recommended by the manufa c tur e r , or by
your phy s ician o r respiratory therapist. A mask sh o uld n o t b e u sed u n les s the CPAP mach ine is tu rned on
and operating prope rly. The vent holes associated with the mask should never b e blocked for proper
exhaling purpose.

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

CAUTION –

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

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DANGER -To reduce the risk of electrocution:

1. Always unplug t his product immediately after using.

2. Do not use while bathing.

3. Do not place or store pr oduct where it can fall or be pull ed 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.

6. Do not re ach into the wate r or other liquids, if product f alls into water or othe r liquids. Unplug it
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.

3. Us e this product only for its intended use as descr ibed in this manual, do not use att achments not
recommended by the manufacturer.

4. N ev er ope r ate this prod uct i f it has a dam ag ed cor d o r plug , if it is not working prop erl y, if it ha s bee n
dropp ed o r d a ma g ed , o r d ropp ed in to w at e r. R etu rn the p rod uc t to a s er v ic e c e nt e r fo r e x amin a tion a nd
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 or hose.

8. Follow the national requirement to dispose unit.

9. Recommended operating atmospheric condition is above sea level up to 8000 fee t, if goes higher than
8000 feet, re-calibration is then required.

10. Do not operate the device before mask and water chamber insta lled.

11. Disconnect the wate r ch ambe r from the devic e when not in use, water e ntering the device m ay r esult in

electr ic shock hazard or damage.

12. Do not use if water comes in contact with the device or enters the tubing.

13. This device is not for use with patients whose supraglottic airways have been bypassed.

14. Do not use this device on the floor.

15. Do not cover blanket or clo thes on t he device.

16. Do not remove w ater c hamb er while humidifier is heating. Do not touch the heater plate for 30 minutes

after the device is disconnected from the mains.

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1. Intro du ction

This manual should be used for initial set up of the system and saved for reference purpose.

1.1 General Information

Obstruc tive Sleep Apne a (OSA ) is a condition that a n intermitted and r epetitive o bstruction of the
upper respiratory tra ct causes a complete (apne a) or pa rtial (hypopnea) block of bre athing airflow
during sleep. The syndrome varies depe nding on th e degree o f relaxation of the tongue and soft
palate muscl e.

The mos t commo n tre atm en t fo r OS A is Continuous Positive Airw ay Pr essu re (C PAP). CPAP devic es
can deliver a constant air pressu re into your uppe r air way via a nasal mask. This constant air pressure
can keep yo ur airway open during sl eep, therefore prevents the OSA.

This device is a mic ro-processo r controlled continuous positive air way pressure devi ce. It features
the illuminated , menu -driv en LCD display, u nivers al pow er supply, an d r amp time adjustmen t. The
ramp time adjustment and ultra quiet operation ensure you to fall asleep comfortably while air
pressu re slo wly build up to tr eatment l evel. Th e use r c omplianc e mete r re cor ds the to tal system’s
operating time for physician’s reference.

EMC Warnin g Statement

This equipment has been tested and found to comply with the limits for medical devices to the
IEC 60601-1-2:2004. These limits are designed to provide reasonable protection against harmful
interf er enc e in a typ ical med ical installation. This equipme nt gene ra tes, uses an d c an radi ate rad io
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 occu r in a p artic ular installa tion. I f this equ ipment do es c aus e h ar mful inte rf e re n ce to othe r
devices, which ca n be d ete rmined 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 se paration 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.

This system has been tested and compliance to the following volunteer standards:
FDA

1.2 Intended Use

This devic e is intend ed to provid e continuo us positive airw ay pr essure (CPAP) for th e tre atment o f
adult Obstru ctive Sleep Apn ea (OSA ). Th e integ rate d h eat ed hu midifier is d esigne d to inc re ase the
humidity of the ai r f ro m the CPAP ther e by r e lie ving the symptoms of a d ry n ose and th ro at th at s ome
people may experience.

NOTE: Equipment not suitable for use in the pre sen c e o f a fla mma ble anesthe tic mix tur e with
air or with oxygen or nitrous oxide.

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2. Pro du c t Description

Components including:
(1) Main CPAP device with integrated heated humidifier
(2) Detachable power cord
(3) User manual
(4) Flexible air tubing with 1.8 m length
(5) Full face or 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 E asy Complianc e 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 the personal computer for data

downloading. This may cause the CPAP system fai lure

Air Filter

USB Connector

Power Switch

UP Button

DOWN Button

LCD Display

MENU

START/STANDB
Y

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Water Chamber: The wat er ch amber con tains the water fo r humidification. Its remova ble

base plate allows itself ease for cleaning.

Fill Line: Symbol indicates the maximum lev el of water that water chambe r can

contain.

Baffler: The baffler can prevent water spillage due to improper shaking.
Heater Plate: Warms the water in the water chamber.
Heater Plate Switch: When the switch is pressed against the water chamber, the heater plate will

start to work.

Control Knob: This control knob, graduated from 1 to 6, is used to adjust the h eating

tem perature of the heater plate from 30°C to 60°C.

Power On Indicator

(Green LED):

When lit, this indicates the humidifier is turned on and ready for operation.

Heater On In dicator

(Yellow LED):

When lit, this indicates the heater is turned on.

Inlet Port with Silicon
Connector:

Connect to the outlet port of the CPAP device.

Ou tlet port: Connect the flexible tubing here.
Water Chambe r Slider: Lock and unlock the water chamb e r

Outlet Port

Power ON
Indicator

Heater ON
Indicator

Control Knob

Power Socket

Water Chamber

Slider

Fill Line

Removable

Base

Heater Plate

Heater Plate
Switch

Inlet Port

Baffler
(Inside Wate r Chamber)

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3. Installation

3.1 Unpac king

To secure its contents inside, the device and accessories are bundled in a paper packaged box.
Unpack this box by removing the device and its accessory and checking for any damage, which may
have occurred during sh ipping. If there are damages, please contact your dea ler immediately.

3.2 Setting Up

1) Place the device on a flat surface and at a lower
level than your sleeping position.

2) Connect the power cord to the device and plug
into main electrical outlet. Turn on the device
by pressing the ON/OFF s w itch on the left side
of the device

Once the device is turned on, it is in ready to
operate position (“STANDBY” sign appears in
LCD display)

NOTE: The plug is also served to
disconnect the device.

3) Connect one end o f th e ai r tubing firmly to the
air outlet on the back o f the device . As shown
in the left figure.

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