Humidcare Instruction Manual

Contents Important Safeguards... 1 Note, Caution and Warning Statements... 2 1. Introduction... 3 2. Product Description ... 4 3. Installation ... 5 4. Operation ... 6 5. Cleaning ... 7 6. Service ... 8 7. Troubleshooting... 8 8. Technical Description ... 9

IMPORTANT SAFEGUARDS SAVE THESE INSTRUCTIONS. READ ALL INSTRUCTIONS BEFORE USING. DANGER -- To reduce the risk of electrocution: z

Always unplug this product immediately after using.

z

Do not use while bathing.

GROUNDING INSTRUCTIONS This product should be grounded. In the event of an electrical short circuit grounding reduces the risk of electric shock by providing an escape wire for the electric current. This product is equipped with a cord having a grounding wire with a grounding plug. The plug must be plugged into an outlet that is properly installed and grounded. DANGER-improper use of the grounding plug can result in a risk of electric shock.

z

Do not place or store product where it can fall or be pulled into a tub or sink.

If repair or replacement of the cord or plug is necessary, do not connect the grounding wire to either flat

z

Do not place in or drop into water or other liquid.

blade terminal. The wire with insulation having an outer surface that is green with or without yellow

z

Do not reach for a product that has fallen into water. Unplug immediately.

stripes is the grounding wire.

z

Do not reach into the water or other liquids, if product falls into water or other liquids. Unplug it Check with a qualified electrician or serviceman if the grounding instructions are not completely

immediately.

understood, or if in doubt as to whether the product is properly grounded. WARNING – To reduce the risk of burns, electrocution, fire, or injury to persons. z

Do not operate CPAP (Continuous Positive Airway Pressure, which is used for Obstructive Sleep Apnea treatment) before mask and humidifier installed

z

Disconnect the humidifier from CPAP unit when not in use, water entering the CPAP unit may result

z

Do not use if water comes in contact with the CPAP unit or enters the tubing.

z

HumidCare Heated Humidifier is not for use with patients whose supraglottic airways have been

z

Do not cover blanket or clothes on the humidifier.

z

Do not remove water chamber while humidifier is heating. Do not touch the heater plate for 30

z

This product should never be left unattended when plugged in.

in electric shock hazard or damage to the CPAP unit.

If is necessary to use an extension cord, use only a 3-wire extension cord that has a three-balde grounding plug, and a 3-slot receptacle that will accept the plug on the product. Replace or repair a damaged cord.

GROUNDING METH (For 120V System Only)

bypassed.

minutes after the device is disconnected from the mains. z

Close supervision is necessary when this product is used by, on or near children or individuals.

z

Use this product only for its intended use as described in this manual. Use this product only under physician’s direction. Do not use the equipment with accessories other that those supplied with this set. Contact your local dealer/EU representative for additional information.

z

Never operate this product if a) it has a damaged cord or plug, b) it is not working properly, c) it has been dropped or damaged, d) it has been dropped into water. Return the product to a specified service center or distributor or EU representative for examination and repair.

z

Keep the cord away from heated or hot surfaces.

z

Never block the air openings of this product or allow objects to fall or be inserted into the air vent

z

This device SHALL NOT be used if the room temperature is warmer than 35℃(95℉) to prevent the

openings or place it on a soft surface such as bed or couch, where the air openings may be blocked. temperature of air delivered to nasal mask over 41℃(104℉). CAUTION – z

Use humidifier accompanied with SRT or LRT series CPAP system and CE certified or 510(k) cleared accessories

NOTE – z

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

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8 Technical Description

NOTE, CAUTION AND WARNING STATEMENTS

Item

Specification

Model No.

9S-004000

POWER REQUIREMENT:

DANGER:

serious injury if not avoided.

120VAC, 50/60Hz, 0.9A (For 120V system)

(see rating label on the product)

220V-240VAC, 50/60Hz, 0.5A (For 230V system)

Fuse Rating

T2A, 250 VAC

DIMENSIONS:

WARNING:

(1.53lb)

Water Chamber: 165g

(0.36lb)

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

Heater: 38.5 x 20 x 4 cm (15.16”x7.87”x1.57”) Heater: 395g

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

CAUTION:

Water Chamber: 14.3 x 11 x 11.3cm (5.63”x4.33”x4.45”) WIEGHT:

Danger indicates an immediately hazardous situation which will result in death or

NOTE:

Note indicate some tips that user should pay attention to.

SYMBOLS

WATER CAPACITY:

450ml

HEATER SETTINGS:

1 to 6 from 30°C-60°C

“BF” symbol, indicate this product is according to the degree of protecting against

PRESSURE DROP:

0.2cmH2O @ 60LPM

electric shock for type BF equipment.

HUMIDITY OUTPUT:

10-40mgH2O/L

OPERATING ENVIROMENT

TEMPERATURE: 10°C-35°C HUMIDITY: 10%-90%RH ATMOSPHERIC PRESSURE: 609-768mmHg

TRANSPORT/STORAGE

TEMPERATURE: -20°C-70°C

ENVIROMENT

HUMIDITY: 10%-90%RH ATMOSPHERIC PRESSURE: 609-768mmHg

Classification

COMPLIANCE STANDARD:

Class I, Type BF, IPX0

!

Attention, should read the instructions before use. Grounding terminal Fill line Air flow direction

Applied Parts: Nasal Mask

Disposal of Electrical & Electronic Equipment (WEEE):

Not suitable for use in the presence of a flammable anesthetic mixture

This product should be handed over to an applicable collection point for the recycling of

(No AP/APG Protection)

electrical and electronic equipment. For more detailed information about the recycling of

Continuous operation.

this product, please contact your local city office, household waste disposal service or

UL60601-1/EN60601-1

the retail store where you purchased this product.

CAN/CSA C22.2 No.601.1 NOTE: 1. The specification is also suitable for other areas operating with same power supply. 2. Consult the distributor or EU representative for other technical documents.

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2

1 Introduction

6 Service

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

If the heated humidifier malfunction or doesn’t work, contact your equipment provider service agent immediately. Never try to open the enclosure of heated humidifier. The heated humidifier

1.1 General Information

maintenance needs qualified maintenance personnel.

This system has been tested and successfully approved to the following standards.

NOTE: Follow the national requirements to dispose the device.

EN60601-1 EN60601-1-2

7 Troubleshooting

0197 E228589 53DG

Medical Equipment- Heated Humidifier

The table below lists troubleshooting solutions for the problems that may happen. If the problem persists,

with respect to electrical shock, fire and

contact your equipment provider service agent.

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

Problem

Possible Causes

C22.2 No.601.1. prévenant les choc électrique, le feu et les risques de blessures physiques.

Power on indicator

1. Power cord not plug into a working 1. Plug in the power cord to a working AC

not light

Solutions outlet.

AC outlet.

2. See Setup procedure and turn the

2. Power switch is not turned on

EMC Warning Statement

power on.

3. PCB or indicator worn out

This equipment has been tested and found to comply with the limits for medical devices to the

3. Contact your local agent or EU

4. Fuse blown out

EN 601-1-2:2001. These limits are designed to provide reasonable protection against harmful

representative for service.

interference in a typical medical installation. This equipment generates, uses and can radiate radio

4. Contact your local agent or EU

frequency energy and, if not installed and used in accordance with the instructions, may cause harmful

representative for service.

interference to other devices in the vicinity. However, there is no guarantee that interference will not

Heater on indicator 1. heater plate over heated

occur in a particular installation. If this equipment does cause harmful interference to other devices,

not light at all

1. Contact your local agent or EU

2. PCB indicator worn out

representative for service. 2. Contact your local agent or EU

which can be determined by turning the equipment off and on, the user is encouraged to try to correct

representative for service.

the interference by one or more of the following measures: - Reorient or relocate the receiving device. - Increase the separation between the equipment.

There is no air flow 1. CPAP device is not turned on or

1. Refer to your CPAP user manual.

on through the mask

2. Reconnect the flexible tubing correctly.

- Connect the equipment into an outlet on a circuit different from that to which the other device(s) are

3. Flexible tube is blocking. Condensation in

1. The heater plate setting is too high. 1. Adjust the control knob to low temperature setting.

mask or flexible tube 2. The operating environment or This system has been tested and compliance to the following volunteer standards.

position of heated humidifier is not 2. Remove any air conditioner which may properly. The temperature close to

„ FDA Water Leakage

1.2 Intended use HumidCare Heated Humidifier is for use with SRT or LRT series CPAP system. It had been designed to increase the humidity of the air from the CPAP thereby relieving the symptoms of a dry nose and throat that some people may experience.

3. Unblock the flexible tube.

right.

connected. - Consult the manufacturer or field service technician for help.

working correctly 2. Flexible tubing is not connected

nearby the heated humidifier. Or keep

mask or flexible tube is low.

room temperature up near 25℃。

1. Assembly of water chamber is not

2. remove the water chamber from the

proper or incorrectly.

heated humidifier, pull out the water

2. Water chamber or removable base plate worn out.

and reassemble the water chamber again, make sure the removable base plate is right fit into water chamber, and fill the water till it reach fill line

NOTE: Equipment not suitable for use in the presence of a flammable anesthetic

and check if it still leak or not. 3. Replace a new water chamber.

mixture with air or with oxygen or nitrous oxide.

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2 Product description 5. Connect the other end of the flexible tubing to your mask.

Flow Direction

Baffler

Water Chamber

Silicon Connector Outlet Port

Inlet Port

Removable Base Plate

6. Adjust the heater temperature to the desired setting by the control knob. The 1-6 setting corresponds to the temperature as follows: 1 = about 30°C 2 = about 39°C 3 = about 43°C 4 = about 47°C 5 = about 51°C 6 = about 60°C

The system is ready for use. Consult the CPAP user’s manual for operating instructions. Danger: In order to avoid the destruction or damages of the CPAP equipment or even the hazard of electric shock, when the water chamber is connected to the outlet port of CPAP, DO NOT fill water from the outlet port of the water chamber. Users must fill water no more than the marking for maximum volume after the water chamber is removed from the heater device and CPAP.

5

Cleaning

5.1 Heater z

Clean the heater by wiping it with a damp cloth. Allow the heater to air dry before connecting the power cord.

z

Inspect the heater and power cord for any damage and replace it if necessary.

5.2 Water Chamber

Fill Line Extraction Tool

Heater Platform Heater ON Indicator Power Switch

Heater Plate Switch

Control Knob Heater Plate

The water chamber contains the water for humidification. Its removable base plate allows itself ease for cleaning.

Fill Line:

Symbol indicates the maximum level of water that water chamber can contain.

Flow Direction:

Symbol Indicates the air flow direction

Baffler:

The baffler can prevent water spillage due to improper shaking.

Extraction Tool:

Open the water chamber for cleaning.

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 heating temperature 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 Indicator (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.

Outlet port:

Connect the flexible tubing here.

AC Power Cord:

Connect to an AC outlet providing main power to the heated humidifier.

Power Socket:

Connect the AC power cord here.

Power Switch:

Turn the HumidCare heated humidifier ON or OFF.

and slide it out of the heater. Empty the remaining water. 3. Use the extraction tool to remove the chamber base. Match the indent on the extraction tool to the remark on the water chamber. Use the dotted line on the tool as the pivot and flip it over to remove the base. 4. Use a mild detergent to wash all the chamber parts. Rinse all the parts with clear water and allow them to air dry. 5. All items of the chamber are subject to normal wear and tear and may eventually be replaced. Replace the chamber parts if any damage is present.

7

Power Cord Power Socket

Water Chamber:

1. Turn the device off and allow the heater and water to cool. 2. Disconnect the flexible tubing from the water chamber. Press down on the water chamber

Power ON Indicator

4

3.

Installation

4

3.1 Set Up

Operation

4.1 Operating instruction 1. Place the CPAP device on the heater platform. Position the CPAP device so that the four feet match up with the platform.

Daily Use 1. Turn on the heater by pressing On/Off switch on the back of the heater platform. The heater power on indicator will be lit (green light)

2. Place the CPAP and heater platform on a flat surface and at a lower level than your sleeping position.

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

3. Connect the power cord to the power socket on the back of the heater, and plug it into main outlet. NOTE: 1. Make sure the heated humidifier unit is suitable for the

Silicon Connector

with distilled

3. Press down and slide the chamber into place. Make sure the silicon connector on the inlet connector fit securely over the CPAP device air outlet. Note: Make sure the water chamber is pushed to the end to press against the heater plate switch. At the same time, the heater on indicator will be lit to indicate the heater plate starts to warm. Note: The heater will be automatically turned off while the water chamber is removed from the heater platform.

local power voltage. 2. The plug is also served as the disconnect device.

4. Connect the power cord to the power socket on the back of the CPAP device, and plug it into main outlet. Heater Plate Switch

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

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