斯百瑞®BPAP 30/BPAP A30

斯百瑞®BPAP 30/BPAP A30
Sepray CPAP 25/CPAP A25
User Manual
MICOMME MEDICAL
0123
Sepray CPAP 25/CPAP A25 user manual V2.0
micomme, Sepray,
, are registered trademarks of Micomme Medical Technology
Development Co., Ltd.
All rights reserved.
Modes: Sepray CPAP 25,Sepray CPAP A25
Manufacturer: Micomme Medical Technology Development Co., Ltd.
Website: http://www.micomme.com
Hotline: +86-4000-2000-33
Fax: +86-0731-89916333
E-mail: info@micomme.com
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Sepray CPAP 25/CPAP A25 user manual V2.0
Table of Contents
INTRODUCTION........................................................................................................................... 4
INTENDED USE...................................................................................................................................4
CONTRAINDICATIONS:......................................................................................................................6
ADVERSE EFFECTS............................................................................................................................ 6
SYSTEM CONTENTS.................................................................................................................... 6
ACCESSORIES LIST.................................................................................................................... 7
SYSTEM OVERVIEW................................................................................................................... 7
SYMBOLS........................................................................................................................................ 9
USING THE DEVICE.................................................................................................................... 9
DEVICE SETTING.......................................................................................................................10
NAVIGATING THE DEVICE SCREENS................................................................................11
USER MODE:.................................................................................................................................... 11
STANDBY SCREEN............................................................................................................................ 11
TREATMENT SCREEN......................................................................................................................12
INFORMATION SCREEN...................................................................................................................13
SETTING
SCREEN......................................................................................................................... 13
PROVIDER MODE.............................................................................................................................14
TREATMENT PARAMETER SETTING................................................................................ 14
CPAP 25 TREATMENT PARAMETER SETTING..............................................................................14
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Sepray CPAP 25/CPAP A25 user manual V2.0
CPAP A25 TREATMENT PARAMETER SETTING:.......................................................................16
HUMIDIFIER................................................................................................................................ 18
HUMIDIFIER SPECIFICATIONS:......................................................................................................18
INSTALLATION HUMIDIFIER...........................................................................................................18
DEVICE ALERT........................................................................................................................... 20
ALERT SUMMARY TABLE:............................................................................................................. 21
DEVICE CLEANING AND MAINTENANCE....................................................................... 23
CLEANING HUMIDIFIER WATER CHAMBER..................................................................................24
TROUBLESHOOTING............................................................................................................... 24
TECHNICAL SPECIFICATIONS.............................................................................................26
PERFORMANCE PARAMETERS:......................................................................................................26
HUMIDIFIER PARAMETERS:...........................................................................................................26
ENVIRONMENTAL............................................................................................................................27
PHYSICAL AND ELECTRICAL CLASSIFICATION.......................................................................... 27
DISPOSAL......................................................................................................................................27
EMC INFORMATION................................................................................................................ 28
LIMITED WARRANTY...............................................................................................................33
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Sepray CPAP 25/CPAP A25 user manual V2.0
Introduction
Intended Use
The Sepray CPAP 25 and CPAP A25 are Continuous Positive Airway Pressure devices designed
for the treatment of Obstructive Sleep Apnea in spontaneously breathing adult patients. The
patients weight should over 30kg. It is for use in the home or hospital.
These devices should only be used with guidance of trained medical staff.
Mask should be compatible for use as manufacturer recommended with the device.
The system can deliver CPAP therapy or Auto CPAP therapy. Your home care provider will make
the correct pressure settings according to your health care professional’s prescription.
WARNINGS:
A warning indicates the possibility of injury to the user or the operator.
This manual serves as a reference. The instructions in this manual are not intended to
supersede the health care professional’s instructions regarding the use of the device.

The operator should read and understand this entire manual before using the device.

This device is not intended for life support.

The device should be used only with masks and connectors recommended by MICOMME Co.
or with those recommended by the health care professional.

A mask should not be used unless the device is turned on and operate properly.

The mask is treated as the applied part, which is not intended to deliver heat, during normal
user, the maximum temperature of applied part maybe up to 42°C.

Never block the exhalation port(s) associated with the mask.

Do not use accessories, detachable parts and materials that manufacturer NOT recommended.
That will degrade the device’s performance.

Do not arbitrary interconnect the device to other equipment not described in the instructions
for use.

Do not connect the device to high pressure oxygen supply source.

When using oxygen with this system, the oxygen supply must comply with local regulations
for medical oxygen. The device should keep 1meter distance from oxygen supply at least.

When using oxygen with this system, turn the device on before turning on the oxygen. Turn
the oxygen off before turning the device off. This will prevent oxygen accumulation in the
device. Oxygen accumulated in the device enclosure will create a risk of fire.

Do not use the device near a source of toxic or harmful vapors.

Do not use this device if the room temperature is higher than 35°C (95° F). If the device is
used at room whose temperatures higher than 35°C (95° F), the temperature of the airflow
may exceed 43°C (109° F). This could cause irritation or injury to your airway.

Do not operate the device in direct sunlight or near a heating appliance because these

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Sepray CPAP 25/CPAP A25 user manual V2.0
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


conditions can increase the temperature of the air coming out of the device.
Do not operate the device in dusty environment, dust should occlude input filter, case some
person allergy.
If you notice any unexplained changes in the performance of this device, if it is making
unusual or harsh sounds, if it has been dropped or mishandled, if water is spilled into the
enclosure, or if the enclosure is broken, disconnect the power cord and discontinue use.
Contact your home care provider.
Repairs and adjustments must be performed by MICOMME -authorized service personnel
only. Unauthorized service could cause injury, invalidate the warranty, or result in costly
damage.
The patient is an intended operator, the patient should adjust parameters under user mode for
safety.
Do not service or maintain the machine while in use with the patient.
No modification of this equipment is allowed.
Periodically inspect electrical cords and cables for damage or signs of wear. Discontinue to
use and replace if damaged.
The plug is used as disconnect to the mains supply, do not position the device so that it is
difficult to operate the disconnection device.
The separate power supply is specified as part of the device.
Be sure to route the power cord in a right way that will prevent the cord from being tripped
over or interfered with by furniture, prevent power cord twine neck cause strangulation.
If the device is used by multiple persons (such as rental devices), a low-resistance, main flow
bacteria filter should be installed in-line between the device and the circuit tubing to prevent
contamination. And one person just use one set of disposable mask and tube.
For safe operation when using the humidifier, the humidifier must always be positioned
below the breathing circuit connection at the mask and the air outlet on the device. The
humidifier must be level for proper operation.
The device blower design life is 15,000 hours.
The accessories service life, please refer to the provider’s instruction in the isolated package.
CAUTIONS:
A Caution indicates the possibility of damage to the device.







Do not use this device if the room temperature is out of 5°C-35°C.
Do not place the device directly onto carpet, fabric, or other flammable materials.
Never install a wet filter into the device. You must ensure sufficient drying time for the
cleaned filter.
Dirty inlet filters may cause high operating temperatures that may affect device performance.
Regularly examine the device as needed for integrity and cleanliness.
Medical electrical equipment needs special precautions regarding EMC and needs to be
installed according to EMC information. Contact your home care provider regarding EMC
installation information.
Mobile RF communications equipment can affect medical electrical equipment.
Any assistance in setting up, using, maintaining, or report events, unexpected operation,
please contact manufacturer or local manufacturer’s representative.
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Sepray CPAP 25/CPAP A25 user manual V2.0
Contraindications:
If you have severe respiratory failure and can not even breath spontaneously, please do not use
this device. If any of the following situations matches with you, please contact your professional
health care staff before you use this machine:

Respiratory drive is not sufficient to withstand intermittent therapy;

Acute sinusitis, otitis media;

Unable to clear secretions;

Low blood pressure or obviously insufficient endovascular blood volume;

Pneumothorax or pneumomediastinum;

Brain trauma or surgery;

Airway colostomy surgery;

Bullous lung disease.
Adverse Effects
The following side effects may arise during the course of therapy with the device:





Drying of mouth, nose or throat;
Bloating;
Ear or sinus discomfort; eye irritation;
Skin rashes;
Chest discomfort;
System Contents
Sepray CPAP 25, CPAP A25 System include:
Main unit

User manual

Power cord

Power supply

Micro SD Card

Carrying case

Reusable gray foam filter

Humidifier chamber

Flexible tubing

Mask (optional)

NOTES:
If any of these items are missing, please contact your home care provider.
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Sepray CPAP 25/CPAP A25 user manual V2.0
Accessories list



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
Micro SD Card
Carrying case
Reusable gray foam filter
Humidifier chamber
Flexible tubing
Mask (optional)
System overview
1. Alarm reset button
2. Ramp button
3. LCD screen
4. Wheel/Push control button
5. Air outlet port
6. Humidifier chamber
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Sepray CPAP 25/CPAP A25 user manual V2.0
7. Humidifier cover
8. Unit shell
9. Unit bottom
10. Micro SD card
11. Interface cover
12. Power inlet
13. Air inlet/filter
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Sepray CPAP 25/CPAP A25 user manual V2.0
Symbols
Symbols
Description
Caution
Type BF Applied Part
Class II (Double Insulated)
IP21
Water proof level: no protection, no special protection
Do not disassemble.
DISPOSAL: Do not dispose this product as unsorted municipal waste.
Collection of such waste separately for special treatment is necessary.
Ramp
COMF function
Humidifier start
Yellow LED, medium priority alarm
Red LED, high priority alarm
Alarm off
Alarm pause
Alarm reset
Using the device
1. Install the filter
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Sepray CPAP 25/CPAP A25 user manual V2.0
CAUTION:
The filter must be in place at all times when the device is operating.
2. Put your device on a firm, flat surface.
NOTES:
Suggested the device position is lower than your sleeping position.
WARNING:
Never block the air inlet when the device is operating!
3. Input Micro SD card
NOTES:
Micro SD card can storage the therapy data. The device can works normally without Micro SD
card.
4. Add water into humidifier chamber and keep water line below the Max limited line.
5. Connect the tubing firmly onto the device air out let port; and connect the other end of tubing to
the mask.
CAUTION:
Please refer to your mask instructions.
6. Plug power cord to the device power inlet socket.
7. Press the Wheel/Push control button to start or off the device.
Device setting
Sepray CPAP 25 and CPAP A25 have two operating mode: user mode and provider mode.
User mode: users can change some parameters related to COMF by themselves.
Provider mode: medical professionals should use this mode adjust all therapy parameters.
WARNING:
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Sepray CPAP 25/CPAP A25 user manual V2.0
Only medical professionals should be allowed to use this mode to adjust pressure settings.
Provider mode unlocks settings that cannot be modified by the user.
Navigating the Device Screens
User mode:
1. Make sure power is on, the device enter standby screen.
2. Use the Wheel/Push control button move the cursor on [Sys.] soft key to set parameters.
3. Use the Wheel/Push control button move the cursor on [Treat] soft key to start or off the
device.
Standby screen
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Sepray CPAP 25/CPAP A25 user manual V2.0
Treatment screen
: Real time display CPAP pressure
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Sepray CPAP 25/CPAP A25 user manual V2.0
Information screen
Setting screen
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Sepray CPAP 25/CPAP A25 user manual V2.0
Provider mode
1. Make sure power is on, the device enter standby screen.
2. Use the Wheel/Push control button move the cursor on [Sys.] soft key.
3. Press the “Ramp button” and press the “wheel button” simultaneously, then, release all button,
the device enters provider mode.
NOTES:
When you enter the provider mode, the [Treat] soft key display changes to [Back].
4. Exit provider mode, move cursor on [Back], press “wheel button” exit to user mode.
Treatment parameter setting
CPAP 25 treatment parameter setting
Parameter
Range
BACK
Description
Mode
return to previous menu
User mode/Provider
mode
Mode
CPAP
CPAP mode:Continuous Positive
Airway Pressure
CPAP
4 ~ 20 cmH2O
Setting Continuous Positive Airway
Pressure.
COMF
COMF Level
On/Off
1 ~ 3 level
Provider mode
Provider mode
Turn on or turn off the COMF
User mode/Provider
function
mode
Adjust COMF level from 1 to 3,
COMF effect will increase
synchronously.
Note: The parameter is visible only
User mode/Provider
mode
when COMF is ON.
Ramp Time
Off ~ 45 min
Set pressure ramp time from
User mode/Provider
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Sepray CPAP 25/CPAP A25 user manual V2.0
Ramp Pressure
4 cmH2O ~ CPAP
0-45 min
mode
Set ramp start pressure.
User mode/Provider
mode
Humidifier
Auto On
OFF ~ 5 level
Off/On
This setting allows you to choose
User mode/Provider
the desired humidity setting level.
mode
ON: when you fit your mask and
normal breath several times, the
User mode/Provider
device will automatically turn the
mode
airflow on.
Auto Off
Off/On
ON: when you remove your mask 2
minutes, the device will
automatically turn to standby status.
Mask Alert
Off/On
User mode/Provider
mode
ON: When the circuit is
disconnected or there is a large air
User mode/Provider
leak in mask,mask alert function
mode
available.
LED Backlight
Auto/On
Auto: Display LCD automatics
turn to dark, (Nobody touches any
User mode/Provider
button in 5 minutes).
mode
ON: Display LCD always lighting.
Language
English/Chinese
Choose language
User mode/Provider
mode
Reset Factory
Off/On
ON: Reset to Factory setting
Set
Memory Space
Micro SD Card Memory Space
Provider mode
User mode/Provider
mode
Version
Device soft version
User mode/Provider
mode
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Sepray CPAP 25/CPAP A25 user manual V2.0
CPAP A25 treatment parameter setting
Parameter
Range
Back
Description
Mode
Return to previous menu
User mode/Provider
mode
Mode
CPAP
CPAP mode: Continuous Positive
Auto CPAP
Airway Pressure
Auto CPAP mode: Device adjusts
CPAP pressure automatically based
Provider mode
on monitoring of patient’s
Obstructive Sleep Apnea,
hypopnea, and snoring etc. events.
Max Pressure
Min Pressure
COMF
COMF Level
Min Pressure ~ 20
Set highest limit of variable CPAP
cmH2O
during auto CPAP mode
4 cmH2O ~ Max
Set lowest limit of variable CPAP
Pressure
during auto CPAP mode
On/Off
Turn on or turn off the COMF
User mode/Provider
function
mode
1 ~ 3 level
Provider mode
Provider mode
Adjust COMF level from 1 to
3,COMF effect will increase
synchronously .
Note: The parameter is visible only
User mode/Provider
mode
when COMF is on.
Ramp Time
Ramp Start
Off ~ 45 min
4 cmH2O ~ Min
Set pressure ramp time from 0-
User mode/Provider
45min
mode
Set ramp start pressure.
User mode/Provider
Pressure
Humidifier
Off ~ 5 level
mode
This setting allows you to choose
User mode/Provider
the desired humidity setting level.
mode
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Sepray CPAP 25/CPAP A25 user manual V2.0
Auto On
Off/On
ON: when you fit your mask and
normal breath several times, the
User mode/Provider
device will automatically turn the
mode
airflow on.
Auto Off
Off/On
ON: when you remove your mask 2
minutes, the device will
automatically turn to standby status.
Mask Alert
Off/On
User mode/Provider
mode
ON: When the circuit is
disconnected or there is a large air
User mode/Provider
leak in mask,mask alert function
mode
available.
LED Backlight
Auto/On
Auto: Display LCD automatics
turn to dark, (Nobody touches any
User mode/Provider
button in 5 minutes).
mode
ON: Display LCD always light.
Language
English/Chinese
Choose language
User mode/Provider
mode
Reset Factory
OFF/ON
ON: Reset to Factory setting。
Set
Memory Space
Micro SD Card Memory Space
Provider mode
User mode/Provider
mode
Version
Device soft version
User mode/Provider
mode
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Sepray CPAP 25/CPAP A25 user manual V2.0
Humidifier
Sepray CPAP 25, CPAP A25 standard configuration include humidifier.
Humidifier specifications

Voltage: 24 VDC

Heated plate Max power: 45 W

Chamber capacity: 270 ml

Maximum pressure:30 cm H2O

Input air temperature’s range: 15℃ to 30°C

Static water temperature range: 35~45(±5)°C

Preheating time: less than 60 minutes

Heating plate thermal fuse: 125±10°C

Humidifying ability: more than 10 mg/L

Leakage: less than 20 ml/min (maximum operating pressure: 20 cmH2O)
Installation humidifier
1. Rotate humidifier cover counterclockwise to unlock it.
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Sepray CPAP 25/CPAP A25 user manual V2.0
2. Pull up the cover.
3. Push out the water chamber
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Sepray CPAP 25/CPAP A25 user manual V2.0
4. Inject distilled water as the direction of arrow.
5. Push water chamber back into main unit, install and rotate cover clockwise to locked position”
●” , according to steps 1-4 in reverse operation.
WARNING:

Always ensure humidifier water level under the limited mark.

Don’t touch the humidifier heated plate. The heated plate working temperature sometimes
over 80°C. It may scald your skin.
CAUTION:

When you want to add water in humidifier chamber, please removie the chamber outside the
device first.

Wipe the chamber housing outside water, keep it dry before you install it back to device.
Device Alert
High Priority: These alerts require immediate operator response. The alert signal consists of a
high priority sound. Audible indicator is a continuous three-beep and two-beep pattern (• • • •
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Sepray CPAP 25/CPAP A25 user manual V2.0
•). Visual indicator is red alarm symbol flash.
Low Priority: These alerts require prompt operator response. No need audible indictor. Visual
indicter is yellow prompt symbol illuminated.
Alert Summary Table
The following table summarizes the alerts
Alert type
Alert
Error
code
Description
Possible Cause
Patient Action
Turn off the device. Remove
Blower hall
Blower
failure
E101
Blower
problem
sensor can not
detect blower is
running
the power cord from the
device. Plug the cord back
into the device’s power inlet
to restore power. If the alert
continues to occur, contact
your home care provider
High
Priority
Humidifier
failure
E102
Alert
Humidifier
Humidifier
Turn off the device and
heated plate
heated plate
contact your home care
temperature
temperature
provider
too high
exceed 90°C.
Turn off the device. Remove
the power cord from the
Pressure
sensor
Pressure
E103
failure
sensor
failure
Pressure sensor
failure
device. Plug the cord back
into the device’s power inlet
to restore power. If the alert
continues to occur, contact
your home care provider
Flow sensor
failure
E104
Flow sensor
Flow sensor
Turn off the device. Remove
failure
detected wrong
the power cord from the
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Sepray CPAP 25/CPAP A25 user manual V2.0
data over 30
device. Plug the cord back
seconds.
into the device’s power inlet
to restore power. If the alert
continues to occur, contact
your home care provider
High
pressure
E105
alert
Device
Pressure sensor
Turn off the device and
output
detected output
contact your home care
pressure too
pressure exceeds
provider
high
35 cmH2O over 6
seconds.
Check your mask and tubing.
Pressure sensor
Tubing
disconnect
E106
Tubing
disconnect
detects output
pressure is less
than 0.5 cmH2O
over 30 seconds.
Tubing
obstruction
E107
Check breathing circuit
connections and reconnect
the tubing if it has came
loose. If the alert continues
to occur, contact your home
care provider.
Flow sensor
Check breathing circuit,
Tubing
detect airflow is
make sure no obstruction.
obstruction
zero over 30
seconds.
Mask huge
leakage
Mask Alert
E108
Check your mask and tubing
Flow sensor
detects airflow
exceeds 80L/min
if it has some damage.
Maybe you should
refit
your mask.
over 60 seconds.
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Sepray CPAP 25/CPAP A25 user manual V2.0
Storage card
Storage card
full
Low
E201
full
Contact your home care
Storage card is
provider to download
full.
therapy data, or exchange for
one new storage card.
Priority
Alert
Storage card
removed
Storage card
E202
has been
Insert an available card.
No storage card
removed.
Device cleaning and maintenance

Clean the flexible tubing before first use and daily use.

Clean the mask first use and daily use.

For the mask and flexible tubing, gently wash the tubing in a solution of warm water and a
mild detergent. Rinse thoroughly. Air dry. Use soft cloth to clean the device surface.

Clean the foam filter at least once every two weeks and replace it with a new one every six
months.

Clean the humidifier water chamber once every two weeks.

Suggest replace the mask every 6 months to 12 months according to the smudgy degree, or
follow your mask provider’s instruction

The device does not require routine servicing.
CAUTION:

Do not attempt to open the device. There are no user serviceable parts inside.
WARNING:

If you notice any unexplained changes in the performance of this device, if it is making
unusual or harsh sounds, if water is spilled into the enclosure, if the enclosure is broken,
disconnect the power cord and discontinue use. Contact your home care provider.

The degraded sensors, electrodes, blower, or loosened connector should cause some problems,
degrade device performance. Inspection and repair should only be performed by Micomme
authorized agent or engineers.
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Sepray CPAP 25/CPAP A25 user manual V2.0
Cleaning humidifier water chamber
You can open the water chamber’s cover and cleaning chamber inside.
CAUTION:
After refit the chamber, you should confirm the cover refit tightness. No air leakage.
Troubleshooting
The table below lists some of the problems you may experience with your device and possible
solutions to those problems.
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Sepray CPAP 25/CPAP A25 user manual V2.0
Problem
Possible Cause
Solution
Make sure there is power available at
the outlet.
Make sure the AC power cord is connected
Nothing happens when
No power at the outlet
correctly to the power supply and the
you apply power to the
or the device is
power supply cord is securely connected to
device. Display screen
unplugged
the device’s power inlet. If the problem
is dark.
continues to occur, contact your home care
provider.
Return both the device and power supply
to your provider.
The air filter may be
Clean or replace the air filters.
dirty.
Keep the device away from bedding or
The device may be
curtains that could block the flow of air around
The airflow is much
operating in direct
the device. Make sure the device is away from
warmer than usual
sunlight or near a
direct sunlight and heating equipment.
heater.
Check the humidifier settings.
Humidifier settings is
If the problem continues, contact your home
not correct.
care provider.
Adjust or re-fit cushion and headgear.
Device output air
pressure cannot reach
Air leak
the set CPAP pressure.
Huge leakage.
The airflow pressure
feels too high or too
low.
If necessary, change the mask.
Check humidifier chamber leakage, refit the
chamber cover.
Mask defect
Replace the defected mask
Device settings is not
Contact your home care provider to ensure
correct
your correct therapy parameters.
WARNING:
Inspection and repair should only be performed by Micomme authorized agent or engineers.
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Sepray CPAP 25/CPAP A25 user manual V2.0
Technical Specifications
Performance parameters
Parameters
Range
Accuracy
Factory default setting
CPAP
4 cmH2O - 20 cmH 2O
±2 cmH2O
CPAP mode: 10 cmH2O
Ramp Time
0 - 45 min
±10%
20 min
Ramp Pressure
4 cmH2O - 20 cmH2O (less than
4 cmH2O
setting CPAP)
Inspiratory
<1 cmH2O @30 L/Min;
Impedance
<6 cmH2O @60 L/Min
Exhalation
<1 cmH2O @30 L/Min;
Impedance
<6 cmH2O @60 L/Min
Maximum
Pressure
Flow
± 2 cmH2O
20cmH2O
102 L/min @ 10 cmH2O
±10 L/min
115 L/min @ 20 cmH 2O
Sound Pressure
30 dB(A)
±5 dB(A)
Level
Humidifier parameters
Parameters
Condition
Range (accuracy)
Humidifier Capability
Air flow 20L/min – 40 L/min
>10 mg/L
Pressure Drop
60 L/min
< 2 cmH2O
Humidifier Compliance
N/A
< 0.6 ml/kpa
Maximum Temperature
N/A
< 125℃(±10℃)
Maximum State
N/A
40 cmH2O
Pressure
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Sepray CPAP 25/CPAP A25 user manual V2.0
Leakage
20 cmH2O
< 20 ml/min
Parameters
Operating
Storage
Temperature
5ºC ~ 35ºC
-20ºC ~ 70ºC
Relative Humidity
15% ~ 93%(Non condensing)
0~ 93% (Non condensing)
Atmospheric Pressure
700 hPa ~ 1060hPa
500hPa ~ 1060hPa
Environmental
Physical and Electrical Classification
Parameters
Value
Dimensions
24.5 cm L x 16.0 cm W x 10.5cm H
Weight
1.82kg
AC Power
100 ~ 240VAC, 50/60 Hz
AC current
1.8 A (Max)
DC Power
24 V
DC current
3.33 A (Max))
Protection against electrical shock.
II
Electric shock protection
BF
Degree of protection against liquids
IP21
Sterilization requirement
No
Category equipment
AP/APG
Mode of operation
Continuous
Disposal
Do not dispose of electrical appliances as unsorted municipal waste, use separate collection
facilities. Contact your local government for information regarding the collection systems
27 / 34
Sepray CPAP 25/CPAP A25 user manual V2.0
available. If electrical appliances are disposed of in landfills or dumps, hazardous substances can
leak into the groundwater and get into the food chain, damaging your health and well-being.
EMC information
WARNING:

The appliance needs special precaution regarding EMC and needs to be installed and put into
service according to the EMC information provided in the below tables.

The appliance needs to be installed and put into service in accordance with the information
provided in the accompanying documents.

Wireless communications equipment such as wireless home network devices, mobile phones,
cordless telephones and their base stations, walkie-talkies can affect this applicable and
should be kept at least a distance d away from the appliance. The distance d is calculated by
the manufacturer from the 800 MHz to 2.5 GHz column of tables in the below.
-
Guidance and manufacturer’s declaration – electromagnetic immunity
The model CPAP 25/A25 is intended for use in the electromagnetic environment specified below. The
customer or the user of the model CPAP 25/A25 should ensure that it is used in such an environment.
IEC 60601
Compliance
Electromagnetic environment –
test level
level
guidance
Electrostatic
6 kV contact
6 kV contact
Floors should be wood, concrete or
discharge (ESD)
8 kV air
8 kV air
ceramic tile. If floors are covered with
Immunity test
IEC 61000-4-2
synthetic material, the relative
humidity should be at least 30%.
Electrical fast
2 kV for power
2 kV for power
Mains power quality should be that of
transient/burst
supply lines
supply lines
a typical commercial or hospital
IEC 61000-4-4
environment.
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Surge
1 kV differential
1 kV differential
Mains power quality should be that of
IEC 61000-4-5
mode
mode
a typical commercial or hospital
environment.
Voltage dips, short
<5% UT
<5% UT
Mains power quality should be that of
interruptions and
(>95 % dip in UT)
(>95% dip in UT)
a typical commercial or hospital
voltage variations
for 0,5 cycle
for 0,5 cycle
environment. If the user of the model
on power supply
CPAP 25/A25 requires continued
input lines
40% UT
40 % UT
operation during power mains
IEC 61000-4-11
(60% dip in UT)
(60% dip in UT)
interruptions, it is recommended that
for 5 cycles
for 5 cycles
the model CPAP 25/A25 be powered
from an uninterruptible power supply
Power frequency
70% UT
70% UT
(30% dip in UT)
(30% dip in UT)
for 25 cycles
for 25 cycles
<5% UT
<5% UT
(>95% dip in UT)
(>95% dip in UT)
for 5 sec
for 5 sec
3 A/m
3 A/m
or a battery.
Power frequency magnetic fields
(50/60 Hz)
should be at levels characteristic of a
magnetic field
typical location in a typical
IEC 61000-4-8
commercial or hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
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Sepray CPAP 25/CPAP A25 user manual V2.0
Guidance and manufacturer’s declaration – electromagnetic immunity
The model CPAP 25/A25 is intended for use in the electromagnetic environment specified below. The
customer or the user of the model CPAP 25/A25 should ensure that it is used in such an environment.
Immunity test
IEC 60601 test
Compliance
level
level
Electromagnetic environment – guidance
Portable and mobile RF communications
equipment should be used no closer to any part
of the model CPAP 25/A25, including cables,
than the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
Conducted RF
IEC 61000-4-6
d=1.2√P
3 Vrms
150 kHz to 80
3V
MHz
d=1.2√P
80MHz to 800MHz
d=2.3 √P 800MHz to 2.5 GHz
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2,5
3 V/m
GHz
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 metres
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,a
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Sepray CPAP 25/CPAP A25 user manual V2.0
should be less than the compliance level in
each frequency range.b Interference may occur
in the vicinity of equipment
marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, 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.
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 model CPAP 25/A25 is used exceeds the applicable RF
compliance level above, the model CPAP 25/A25 should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as reorienting
or relocating the model CPAP 25/A25.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.
Guidance and manufacturer’s declaration – electromagnetic emissions
The model CPAP 25/A25 is intended for use in the electromagnetic environment specified below. The
customer or the user of the model CPAP 25/A25 should ensure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment – guidance
The model CPAP 25/A25 uses RF energy only for its
RF emissions
CISPR 11
Group 1
internal function. Therefore, its RF emissions are very
low and are not likely to cause any interference in nearby
electronic equipment.
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Sepray CPAP 25/CPAP A25 user manual V2.0
RF emissions
CISPR 11
Harmonic emissions
Class B
Class A
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
The model CPAP 25/A25 is suitable for use in all
establishments, including domestic establishments and
those directly connected to the public low-voltage power
Complies
supply network that supplies buildings used for domestic
purposes.
IEC 61000-3-3
Recommended separation distances between
portable and mobile RF communications equipment and the model CPAP 25/A25.
The model CPAP 25/A25 is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the model CPAP 25/A25 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the model CPAP 25/A25 as recommended below,
according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
m
Rated maximum output
power of transmitter
80 MHz to 800 MHz
800 MHz to 2,5 GHz
W
150 kHz to 80 MHz
0,01
0.12
0.12
0.23
0,1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
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Sepray CPAP 25/CPAP A25 user manual V2.0
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.
Limited Warranty
Micomme Co. warrants that the main system unit shall be free from defects of workmanship and
materials and will perform in accordance with the product specifications for a period of two (2)
years from the date of sale by Micomme Co. to the dealer. If the product fails to perform in
accordance with the product specifications, Micomme Co. will repair or replace the defective
material or part.
This warranty does not cover damage caused by accident, misuse, abuse, alteration, water ingress,
or other defects not related to material or workmanship.
This warranty period does not include the accessories which are not manufactured by Micomme
Co. (Such as Mask, tubing etc.)
This warranty claims on defective product must be made by the initial consumer at the point of
purchase.
Micomme disclaims all liability for economic loss, loss of profits, overhead, or consequential
damages which may be claimed to arise from any sale or use of this product. Some states do not
allow the exclusion or limitation of incidental or consequential damages, so the above limitation
or exclusion may not applicable to you.
This warranty is given in lieu of all other express warranties. In addition, any implied warranties –
including any warranty of merchantability or fitness for the particular purpose – are limited to two
years.
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Sepray CPAP 25/CPAP A25 user manual V2.0
Some states do not allow limitations on how long an implied warranty lasts, so the above
limitation may not apply to you. This warranty gives you specific legal rights, and you may also
have other rights which vary from region to region.
To exercise your rights under this warranty, contact your local authorized Micomme Co. dealer or
contact Micomme Medical Technology Development Co., Ltd.
MANUFACTURER:
Micomme Medical Technology Development Co., Ltd.
Address: Room101-102, North 1st Floor, Superstar Enterprise Center, No8, Lujing Road,
High-Tech Zone, 410205, Changsha, Hunan, PEOPLE’S REPUBILIC OF CHINA
Website: http:/www.micomme.com
Hot line: +86-4000-2000-33
Fax: +86-0731-89916333
E-mail: info@micomme.com
EU AUTHORISED REPRESENTATIVE:
Shanghai International Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537 Hamburg, Germany
Tel: 0049-40-2513175
Fax: 0049-40-255726
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