Somnus DM18 APAP User Manual

Somnus
®
DM18 APAP
CPAP
Ventilator
User Manual
Preface
Thank you for purchasing the ventilator manufactured by Dymind Biotech. Read and understand the entire user manual before operating this device. Store this user manual
properly for future reference.
Product name: CPAP Ventilator Model: DM18 APAP Safety classification: class II, type BF protection against electric shock
Contact Info for After-Sales Services
Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd. Address: 2/F, Nanfeng Building B, Nanshan Yungu Innovation Industrial Park, No.1183, Liuxian Blvd,
Taoyuan Street, Nanshan District, Shenzhen 518055, P.R.China European Representative: 5 Bankside, Hanborough Business Park, Witney Ox29 8LJ UK Service Tel: 400-998-7276 Tel: (86-755)26989825 Fax: (86-755)26746162 Email: dymind@dymind.com.cn Website: http://www.dymind.com.cn/english/
Copyright
© Shenzhen Dymind Biotechnology Co., Ltd. All rights reserved. This document contains proprietary information of Shenzhen Dymind Biotechnology Co., Ltd. (hereinafter referred to as Dymind Biotech). No part of this document may be reproduced, copied, modified, disclosed, or transmitted in any form or by any means without prior written consent of Dymind Biotech. This document is intended for users of Dymind Biotech equipment, whom are authorized to use this document as they purchase Dymind Biotech equipment. Unauthorized persons are not allowed to use this document.
All information in this document does not constitute a warranty of any kind, express or implied, including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose. Every effort has been made in the preparation of this document to ensure accuracy of the contents. However, Dymind Biotech assumes no liability or responsibility for any errors or omissions in the contents of this document. Dymind Biotech reserves the right to improve any products to enhance product reliability, functionality, or design.
®
,
®
, and
Somnus
®
are trademarks of Dymind Biotech.
Declaration
This user manual may be modified without notice. Dymind Biotech reserves the right of final interpretation of this user manual. The pictures in this user manual are indicative only. If there is inconsistency between the pictures
and the actual product, the actual product shall govern. Do not use the pictures for other than intended use.
The continuous positive airway pressure (CPAP) ventilator manufactured Dymind Biotech has passed strict clinical test and obtained the national medical equipment registration certificate. The manufacturer is only responsible for the normal working of the device and will not give any commitment to patient illness condition. Please consult your doctor before use and obey the user instructions.
Dymind Biotech shall be responsible for the safety, security, and performance of the product only when all of the following conditions are met:
The assembly, re-commissioning, extension, modification, and repair of the product are performed by the authorized personnel of Dymind Biotech.
The product is operated based on this user manual.
The manufacturer will not be responsible if the user violate the requirements, which leads to malaise on body or any other injury.
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Content
Content
1 Overview ................................................................................................................................................. 1
1.1 Intended Use..................................................................................................................................... 1
1.2 Operation Theory .............................................................................................................................. 1
1.3 Warnings, Cautions and Contraindications....................................................................................... 2
1.3.1 Warnings .................................................................................................................................... 2
1.3.2 Cautions ..................................................................................................................................... 3
1.3.3 Contraindications ....................................................................................................................... 3
1.4 Symbols ............................................................................................................................................ 3
1.5 Quality Guarantee ............................................................................................................................. 4
1.6 Disposal ............................................................................................................................................ 4
2 Installation and Configuration ............................................................................................................. 5
2.1 Device Composition .......................................................................................................................... 5
2.2 Interfaces .......................................................................................................................................... 5
2.3 Installation ......................................................................................................................................... 5
2.4 Operation Panel ................................................................................................................................ 7
2.5 Batch Parameter Settings ................................................................................................................. 8
3 Parameter Settings ................................................................................................................................ 9
3.1 Ramp Time ........................................................................................................................................ 9
3.2 Humidity Level .................................................................................................................................. 9
3.3 User Setup ( Button) ................................................................................................................. 11
3.4 Detailed Setup ( Button + Shuttle Button) ................................................................................ 13
3.4.1 Detailed Treatment Settings ..................................................................................................... 13
3.4.2 Reminder Configuration ........................................................................................................... 15
3.4.3 System Configuration ............................................................................................................... 16
4 Routine Use .......................................................................................................................................... 17
4.1 Treatment Steps .............................................................................................................................. 17
4.2 Sleep Report ................................................................................................................................... 18
4.2.1 Sleep Quality ............................................................................................................................ 18
4.2.2 Sleep Report ............................................................................................................................ 19
5 Cleaning and Maintenance ................................................................................................................. 20
5.1 Daily Cleaning ................................................................................................................................. 20
5.1.1 Cleaning the Mask ................................................................................................................... 20
5.1.2 Cleaning the Water Tub of the Humidifier ................................................................................ 21
5.2 Weekly Cleaning ............................................................................................................................. 21
5.2.1 Cleaning the Air Filter ............................................................................................................... 21
5.2.2 Enclosure ................................................................................................................................. 21
5.2.3 Cleaning the Air Tubing ............................................................................................................ 21
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Content
5.2.4 Cleaning the Headbands.......................................................................................................... 22
5.3 Disinfection ..................................................................................................................................... 22
5.4 Transfer the Device ......................................................................................................................... 22
6 Service and Repair .............................................................................................................................. 23
7 Troubleshooting .................................................................................................................................. 24
Appendix A Specifications .................................................................................................................... 26
A.1 Basic Specification ......................................................................................................................... 26
A.2 Technical Specification ................................................................................................................... 27
Appendix B Terms .................................................................................................................................. 29
Appendix C EMC Requirements ........................................................................................................... 30
Appendix D Packing List ....................................................................................................................... 34
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1.1 Intended Use
The CPAP Ventilator is intended for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing over 30kg (66 lbs). It may be used in the home or hospital.
The CPAP Ventilator has two treatment modes: CPAP and APAP.
CPAP is suitable for the treatment of mild obstructive sleep apnea syndrome (OSAS).
APAP is suitable for the treatment of severe OSAS. In this mode, the device can automatically adjust the pressure.
1 Overview
1 Overview
This device is a portable device for home use. It can be used only after completion of treatment parameter settings under the instruction of a licensed physician.
The clinical manifestations of obstructive sleep apnea syndrome (OSAS) are mainly: snoring, somnolent at day, sleep apneas, excessive urination at night, headache as well as other complications.
1.2 Operation Theory
OSAS usually performs as airway obstruction, disturbance in respiration, which may cause respective complications. The CPAP Ventilator uses dedicated air compressor to compress filtered air from the surrounding environment to produce continuous positive pressure. The positive pressure is transported to the patient through a breathing tube. The upper airway of the patient is kept open under the positive pressure so that the patient can breathe normally. The working principle of the CPAP Ventilator is illustrated by Figure 1-1.
Figure 1-1 Operation Theory
If the positive pressure is set to an excessively low value, the effect of treatment will be affected; if the positive pressure is set to an excessively high value, the patient will feel uncomfortable.
1
1 Overview
Therefore, the patient must undergo pressure titration in hospital before using the CPAP Ventilator. A licensed physician will present a report on usage pressure and perform pressure titration for the patient.
The CPAP Ventilator is operated by using the display screen and control buttons on top of the ventilator. The device functions are adjustable. The CPAP Ventilator is fitted with a heated humidifier, which is used to increase the temperature and humidity of the breathed air so as to prevent mucosa drying in nasal cavity and ensure comfort of the patient.
1.3 Warnings, Cautions and Contraindications
1.3.1 Warnings
Read and understand the entire user manual before operating this device.
This device is not intended for life support.
This device can be used only after completion of treatment parameter settings under the instruction of a licensed physician.
The instructions in this manual are not intended to supersede established medical protocols.
This device must be used together with the accessories (such as the mask, tube, and power adapter) recommended and provided by Dymind Biotech. The use of accessories other than those specified may have an adverse effect on device functions.
When connecting the power adapter, check whether the plug is connected to the device's power interface properly.
This device is not suitable for use in the presence of a flammable anaesthetic mixture in combination with oxygen or air.
Take off the mask in the case of power failure or in the unlikely event of fault conditions.
Do not block the vent holes of the mask. If the vent holes are blocked, the patient will repeatedly breathe in exhaled air, which may cause suffocation.
To avoid scald, do not touch the warm-up plate of the heated humidifier when it is operating.
Discontinue use if you notice any exceptions of the device, such as significant external damage, liquid ingress, excessively hot output air, or unusual sounds.
Do not perform repair or maintenance when the device is operating.
Power supply is specified as a part of this equipment, be sure to use this power supply, or would result in electric shock and other hazards.
It can be unsafe to interconnect the device with other equipment not described in this manual.
Bundle or place the cables and hose properly to advoid strangulation due to excessive length.
Device and system should not be close to other devices or stack. Or it should be observed and verified that it can work normally under his setting, if it has to be closed to other device or stack.
It's possible to lead to the increasing of electromagnetic radiation of the device and system , or the decreasing of noise immunity if accessory and electric cable which are out of stipulation are used, except for the electric cable which are sold as spare parts of internal components by the manufacturer of the device and system.
2
1.3.2 Cautions
Symbol
Description
WARNING
Alerts you to injury if not operating based on the description under this symbol.
Alerts you to device damage if not operating based on the description under this symbol.
Before turning on the device, make sure the power supply is steady and meets the requirements.
The use of communications equipment, electromechanical equipment, or MRI equipment near this device may cause interference to this device and should be kept at a distance.
Do not dissemble or repair the device without authorization. Contact your device supplier if the device is damaged.
Do not immerse the host in any fluids or place the host in an excessively hot and humid environment.
Disconnect the power cord when the device is not in use.
In the home healthcare environment that can unacceptably affect the basic safety and essential performance of the device, please make sure to keep the device away from:
lint, dust, light (including sunlight), etc. pet, pest and children.
Irregular sleep, drinking, fat, obesity, hypnotic or sedatives may aggravate the symptoms
1 Overview
1.3.3 Contraindications
The device is prohibit to use, if patient is among any case below:
Pulmonary bulla indicated by a chest CT scan or X-ray
Pneumothorax, pleural effussion or pneumomediastinum
Hypotension, such as when shock is not treated immediately
Severe coronary heart disease (CHD)
Cerebral spinal fluid leak, traumatic brain injury (TBI), or intracranial pneumatocele
Acute otitis media
Facial trauma, postoperation, deformity
Tacheal secretions excess, sputum excretion
Afer abdominal operation
1.4 Symbols
The symbols that may be found in this document are defined as follows.
You may find the following symbols of the ventilator system:
3
1 Overview
Symbol
Description
Alerts you to injury if not operating based on the description under this symbol.
Serial Number of the product
Date of manufacture
Manufacturer
IP21
Ingress protection
Type BF applied part
Refer to instruction manual
European CE declaration of conformity
Authorized Representative in the European Community
1.5 Quality Guarantee
For failures caused by material and manufacturing, Dymind Biotech offers a 2-year warranty on the host, a one-year warranty on the heated humidifier and a three-month warranty on accessories suc h as the tubing, mask, and water tub. The warranty period starts from the date of shipment to the cu stomer. Within the warranty period, Dymind Biotech offers repair service without charge in accordance with warranty obligations.
If you require the electrical diagram or component list of the CPAP Ventilator in special situations (such as maintenance or connection to other devices), contact Dymind Biotech. We will provide you with part of or the entire electrical diagram of the CPAP Ventilator based on your requirements.
You can get repair service without charge only after producing the warranty card filled in upon purchase of the CPAP Ventilator.
1.6 Disposal
The user of the CPAP Ventilator is required to dispose of the device and related packing materials based on applicable national laws and regulations when the device reaches the end of service life. Observe the following disposal instructions unless otherwise specified:
Send the device that has reached the end of service life to a recycle center. The recycle center enables the user to dispose of the plastic, glass, metal components, printed tube board (PCB), cable, battery, warm-up plate of the heated humidifier, and motor of the device.
Send the hardboard package and protective plastic package to the recycle center.
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2 Installation and Configuration
2 Installation and Configuration
2.1 Device Composition
The CPAP Ventilator consists of a host, humidifier, air tubing, mask, and power adapter (100–240 V AC, 50/60 Hz, 24 V DC).
2.2 Interfaces
- Host
1
- Humidifier
2
- SD card: storing treatment data for up to a year
3
– Air filter and air filter cover: air filter which is used for filtering the dust in the air within device can
4
be installed after filter cover is opened.
- Air inlet
5
- Humidifier separation button: press this button and pull in 2 opposite directions simultaneously,
6
then the host and humidifier will be separated.
- Air outlet: connected to the tubing
7
- DC power: connected to the DC power adapter
8
2.3 Installation
Take the following steps to install the CPAP Ventilator:
1. Connect the host to the heated humidifier.
5
2 Installation and Configuration
In alignment with the air channel and electrical connection of the humidifier, gently push the host so that the connecting clip of the host and that of the humidifier are locked to each other.
2. Inject water into the water tub. a. Press the OPEN button of the humidifier. When the cap pops up, lift the cap and take out
the water tub.
b. Pour a proper amount of purified water into the water tub. Be sure not to exceed the highest
water level.
c. Insert the water tub into the humidifier and gently press on the cap.
Only purified water can be added to the water tub. If running water or mineral water is added, incrustation will occur, affecting the service life of the water tub.
3. Install the air filter.
Gently pinch on both sides in the lower part of the air filter cover, take off the cover, insert the air filter into the cover, insert the upper part of the cover into the pilot hole, and press the lower part of the cover so that the cover is locked.
4. Install the microSD card.
5. Connect to the tubing and put on the mask. a. Connect one end of the tubing to the air outlet of the humidifier and the other end to the
mask with the exhalation port.
b. Gently fit the mask onto your nose, adjust the mask, and gently tighten the four elastic
bands until you have a comfortable fit.
6. Connect to a power supply.
Connect the DC power plug of the power adapter to the DC power interface on the back of the ventilator and connect the AC power plug to the AC power socket.
After power-on, the Home screen of the ventilator appears on the display screen (Figure 2-1).
Figure 2-1 Home screen
The ventilator enters the power-on standby state after being connected to a power supply. The
button is used to start or stop pressure output.
The temperatures on both sides of the DC power adapter increase when the ventilator is operating. It is a normal phenomenon.
Place the ventilator on a firm and flat surface away from any heating or cooling equipment (such as fans, radiators, or air-conditioners). Do not block the vent holes with objects and ensure normal air circulation inside the ventilator.
6
2.4 Operation Panel
2 Installation and Configuration
1 - Control Wheel/Push Button:
The
Pressing: When the control wheel is pressed on the parameter setup screen, the specified
Rotating clockwise/counterclockwise: When the control wheel is rotated in the menu column,
When the control wheel is pressed and held for 3s on the
2 - Display screen 3 -
4 -
information.
5 -
Press the
control wheel
rotating clockwise, and rotating counterclockwise.
function is selected.
the previous/next menu option is selected. When the control wheel is rotated in parameter options, different values are selected or the value of the specified parameter is increased or decreased.
temperature and humidity levels of the humidifier are increased if the ventilator is not in
Warming Up
temperature and humidity levels of the humidifier are reduced.
: Use this button to start or stop treatment.
: Use this button to view the patient's sleep quality report and the ventilator's service
: Use this button to set parameters.
, and
Tube
or
Cooling Down
: A menu, treatment information, and alarm information appear here.
button to enter the user setup screen. Basic parameters such as
can be set. See section 2.5.3 "User Setup".
Mask
Use this button to select a menu option and confirm the selection.
button supports three operations: pressing (for confirming the selection),
screen, the
state, the
Mask Fit
state. If the ventilator is in
Humidity Level
Warming Up
,
Press and held the
detailed setup screen. Detailed treatment parameters such as and
Xlief
6 -
: Use this button to cancel the current operation or return to the previous screen.
button and control wheel at the same time for 3s to enter the
can be set. See section 2.5.4 "Detailed Setup".
Work Mode, Humidity Level
,
7
2 Installation and Configuration
No.
Parameter
Value
1
Mode
CPAP, APAP
2
Treat Pressure (for CPAP only)
4~20 hPa
3
Max Pressure (for APAP only)
4~20 hPa
4
Min Pressure (for APAP only)
4~20 hPa
5
Start Pressure for CPAP only (the initial pressure output when the ramp feature is enabled.)
4~20 hPa
6
Start Pressure for APAP only (the initial pressure output when the ramp feature is enabled.)
4~20 hPa 7
Max Ramp
0~60 min
8
Xlief
1~3
9
I-sensitivity
1~5
10
E-sensitivity
1~5
11
I-rate
1~3
12
Smart Start
On, Off
13
Humidity Level
1~6
2.5 Batch Parameter Settings
The user can set the treatment parameters quickly though Micro SD. (
: Users can set all parameters of device , for details, see
Note
The procedure is as below :
1. Abtain the configuration file from your local agent.
2. Finish the customization of configuration file with the help of your local agent.
3. Copy the configuration file to Micro SD.
4. Insert the Micro SD into the host, Press button 3 seconds under stand-by condition.
The system will input the configuration file , and finish the parameter setting. 13 parameters can be set in the configuration file. See Table 2-1.
Table 2-1 Parameter settings in configuration file
3 Parameter Settings
.)
8
The parameters on the user setup screen (press the button to enter the screen) can be set by the patient. Other parameters must be set by a licensed physician or under the instruction of a
licensed physician.
3.1 Ramp Time
3 Parameter Settings
3 Parameter Settings
You can set ramp on the is disabled by default.)
1. On the
enter the
2. Rotate the control wheel to select the ramp time and press the control wheel to confirm the
selection. When the ramp feature is enabled, the ventilator outputs an initial pressure and slowly increases
the initial pressure to the therapeutic pressure during the predefined ramp time to help the patient fall asleep. When the ramp time ends, the ventilator automatically detects the patient's respiration conditions and adjusts pressure accordingly.
For details about the setting of the ramp time, see section 3.4.1 Detailed Treatment Settings.
screen, rotate the control wheel to the
Home
RAMP
screen (see Figure 3-1).
Figure 3-1 Setting the ramp time
screen to increase the treatment comfort degree. (The ramp feature
Home
menu and press the control wheel to
RAMP
3.2 Humidity Level
When the host is connected to the heated humidifier, you can set the humidity level for the warm-up of the humidifier to ensure that the air output by the ventilator has a proper temperature when being humidified.
Rotate the control wheel to the
Humidity Level
menu and press the button to enter the
Humidity
9
3 Parameter Settings
Figure 3-3 Warming up
Figure 3-4 Cooling down
screen.
Level
Setting the humidity level Rotate the control wheel to select a humidity level for the humidifier and press the button to
confirm the selection (see Figure 3-2).
Figure 3-2 Setting the humidity level
The level of humidity can be set before or after cure. The value of to 6, or it can be set to
(When
Humidity Level
.
Off
is not set to
) Warming up or cooling down
Off
Humidity Level
Before starting treatment, press and held the control wheel for 3s. If the ventilator is not in
Warming Up
or
Cooling Down
increased (see Figure 3-3). If the ventilator is in
state, the temperature and humidity levels of the humidifier are
Warming Up
state, the temperature and
humidity levels of the humidifier are reduced (see Figure 3-4).
During treatment, the ventilator will stop warming when the treatment is stopped.
ranges from 1
Stop warming or cooling
10
Rotate the control wheel to
to stop warming or cooling.
Off
3 Parameter Settings
Parameter
Setting Description
Tube
This parameter specifies the tubing type: Standard (diameter: 22 mm)
Figure 3-5 Stop warming or cooling
Humidity Level is set to a proper value if small drops of condensed water exist inside the groove of the tubing in the next morning. Humidity Level is set to an excessively large value if many water droplets exist inside the tubing and mask; Humidity Level is set to an excessively low value if you feel nose dryness; in these cases, reduce or increase the value of Humidity Level.
When you lie down, keep the ventilator slightly lower than your head so that drops of condensed water flow back to the water tub of the humidifier to prevent respiratory impairment.
Empty water in the water tub of the humidifier when it is not used.
3.3 User Setup ( Button)
Press the
The following parameters can be set by the patient.
Rotate the control wheel clockwise or counterclockwise to switch to other menus or options. Press the control wheel button to confirm the settings, or press the button to cancel the settings.
button to enter the user setup screen (see Figure 3-6).
Figure 3-6 User setup screen
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3 Parameter Settings
Parameter
Setting Description
Mask
This parameter specifies the mask type. Values: Nasal, Full Face
Xlief
The ventilator automatically detects respiratory rhythm when it is operating and reduces the pressure inside the mask during exhalation to increase the patient comfort level. The higher the parameter value, the higher the pressure release level.
The default value is 3. Values: 3, 2, 1, Off
NOTE
The Xlief parameter appears on the user setup screen only when the Xlief parameter on the detailed setup screen is set to Patient by a licensed physician.
I-sensitivity
The inspiratory trigger sensitivity (ITS) of the device. The range is between 1 and 5, and the default value is 3. The higher the value,
the higher the sensitivity.
NOTE
The I-sensitivity appears on the user setup screen only when the I-sensitivity parameter on the detailed setup screen is set to Patient by a licensed physician.
E-sensitivity
The expiratory trigger sensitivity (ETS) of the device. The range is between 1 and 5, and the default value is 3. The higher the value,
the higher the sensitivity.
NOTE
The E-sensitivity appears on the user setup screen only when the E-sensitivity parameter on the detailed setup screen is set to Patient by a licensed physician.
I-rate
The inspiratory flow rate (IFR) of the device. The range is between 1 and 3, and the default value is 2. The higher the value,
the greater the flow rate.
NOTE
The I-rate appears on the user setup screen only when the I-rate parameter on the detailed setup screen is set to Patient by a licensed physician.
Mask Fit
Press the control wheel to start the mask fit function; or press the button to stop.
When the mask does not have air leaks, a prompt is displayed indicating that the mask is worn properly.
When the mask has air leaks, a prompt is displayed indicating that the mask needs to be adjusted.
If the patient does not stop the mask fit function halfway, the ventilator will automatically start treatment 3 minutes after the mask is put on.
Smart Start
When the ventilator is in standby state and the patient puts on the mask and takes deep breathing 2~3 times, the ventilator is started automatically and outputs the predefined pressure. Once the mash is taken off, the therapy will be stopped.
Values: On, Off
NOTE
The Smart Start parameter appears on the user setup screen only when the Smart Start parameter on the detailed setup screen is set to Patient by a licensed physician.
12
3 Parameter Settings
Parameter
Setting Description
Mode
This parameter specifies the work mode of the ventilator. Please set it according to the actual situation.
CPAP: short for Continuous Positive Airway Pressure. The device can provide continuous CPAP according to the different condition of patient.
APAP: short for Automatic Continuous Positive Airway Pressure. The device can adjust and find the best curing pressure automatically according to the sleep condition of patient.
CPAP
Treat Pressure
This parameter specifies the maximum therapeutic pressure in CPAP mode. Value range: 4.0~20.0. The default value is 5.0.
APAP
Max Pressure
This parameter specifies the maximum therapeutic pressure in APAP mode. The default value is 20.0.
Min Pressure
This parameter specifies the minimum therapeutic pressure in APAP mode. The default value is 4.0.
Start Pressure
This parameter specifies the initial pressure output by the ventilator when the ramp feature is enabled.
NOTE
The parameter is displayed only when Max RAMP is not set to Off.
3.4 Detailed Setup ( Button + Shuttle Button)
The parameters on the detailed setup screen must be set by a licensed physician or under the instruction of a licensed physician.
Press and held the button and control wheel at the same time for 3s to enter the detailed setup screen (see Figure 3-7). The treatment parameters, reminder parameters, and system configurations
can be set.
3.4.1 Detailed Treatment Settings
Rotate the control wheel clockwise or counterclockwise on the
Setup
screen to switch to other menus or options. Press the control wheel to confirm the settings, or press the button to cancel the settings.
Figure 3-7 Detailed setup screen
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3 Parameter Settings
Parameter
Setting Description
Max RAMP
This parameter specifies the maximum ramp time. Values:
Off: to disable the ramp feature.
5 minutes/10 minutes/…/55 minutes/60 minutes: user-defined maximum ramp time. If Max RAMP is set to 10 minutes, Ramp Time on the Home screen can be set to OFF, 5 minutes, or 10 minutes.
NOTE
The ramp feature enables slow increase of the therapeutic pressure from the minimum pressure to the maximum pressure during the maximum ramp time, so that the patient can fall asleep more comfortably.
Xlief The ventilator automatically detects respiratory rhythm when it is operating and reduces the pressure inside the mask during exhalation to increase the patient comfort level. The higher the parameter value, the higher the pressure release level. The default value is 3.
Values: 3, 2, 1, Off, Patient.
NOTE
When the parameter is set to Patient, the Xlief parameter appears on the user setup screen and can be set.
I-sensitivity
The inspiratory trigger sensitivity (ITS) of the device. The higher the value, the higher the sensitivity. The default value is 3.
Values: 1, 2, 3, 4, 5, Patient.
NOTE
When the parameter is set to Patient, the parameter appears on the user setup screen and can be set.
E-sensitivity
The expiratory trigger sensitivity (ETS) of the device, including: 1~5, Patient. The default value is 3. The higher the value, the higher the sensitivity.
NOTE
When the parameter is set to Patient, the parameter appears on the user setup screen and can be set.
I-rate
The inspiratory flow rate (IFR) of the device. The default value is 2. The higher the value, the higher the flow rate. Values: 1, 2, 3, Patient.
NOTE
When the parameter is set to Patient, the parameter appears on the user setup screen and can be set.
Mask
This parameter specifies the mask type. Values: Nasal, Full Face
Tube
This parameter specifies the tube type: Standard (diameter: 22 mm)
Smart Start
When the ventilator is in standby state and the patient puts on the mask and takes deep breathing 2~3 times, the ventilator is started automatically and outputs the predefined pressure. Once the mash is taken off, the therapy will be stopped.
Values: On, Off, Patient.
NOTE
When the parameter is set to
Patient
, the
Smart Start
parameter appears on the user setup screen. To enter the user setup screen and enable/disable the Smart Start function, press the button.
14
3 Parameter Settings
Parameter
Setting Description
Mask
This parameter specifies the time for notifying the user of contacting his/her device supplier to replace the mask. The default value is
Off
, indicating that the user is not
notified.
NOTE
The shelf life of mask is 24 months.
It is suggested to change the mask after every 6 months use.
Water Tub
This parameter specifies the time for notifying the user of contacting his/her device supplier to replace the water tub. The default value is
Off
, indicating that the user is
not notified.
Tube
This parameter specifies the time for notifying the user of contacting his/her device supplier to replace the air tubing. The default value is
Off
, indicating that the user is
not notified.
NOTE
The shelf life of air tubing is 3 years.
It is suggested to change the air tubing after every one year use.
Filter
This parameter specifies the time for notifying the user of contacting his/her device supplier to replace the filter. The default value is
Off
, indicating that the user is not
notified.
NOTE
The air filter of the device is not washable. It is suggested to be changed after 3~6 months use. Please contact your local agent for purchasing.
Service
This parameter specifies the time for notifying the user of sending the ventilator to his/her device supplier for maintenance. The default value is
Off
, indicating that the
user is not notified.
3.4.2 Reminder Configuration
Rotate the the
Reminder
control wheel
screen (see Figure 3-8). On the
to the
Reminder
menu on the
Reminder
screen and press the button to enter
Setup
screen, the operator can set the time for
notifying the patient of replacing components or the time for device maintenance.
Figure 3-8 Reminder screen
15
3 Parameter Settings
Parameter
Setting Description
Language
This parameter specifies the language used by the ventilator. Values: English, Chinese, Française, Española, Português, Deutsch, Korean
Restore Def.
This parameter is used to restore the ventilator to factory defaults.
Erase Data
This parameter is used to delete the patient's sleep quality and sleep report data.
Press. Units
This parameter can be set to hPa or cmH2O.
LCD Light
This parameter is used to enable or disable the screen backlight. Values:
Auto: The backlight is turned off some time after no buttons are pressed. The backlight is turned on when a button is pressed.
Always: The backlight is always on.
Set Time
This parameter specifies the current date and time of the ventilator. It is in the format of YYYY-MM-DD hh-mm, for example, 2014-01-01 12:30. Values:
YYYY: specifies the year, for example, 2014.
MM: specifies the month, such as 01.
DD: specifies the date, such as 01.
hh: specifies the hours, such as 12.
mm: specifies the minutes, such as 30.
During operation, the ventilator records the user's usage information based on this clock. Therefore, it is necessary to check the clock accuracy frequently.
3.4.3 System Configuration
Rotate the control wheel to the wheel to enter the
Configuration
Configuration
screen (see Figure 3-9). On the
operator can set such parameters as
Figure 3-9 Configuration screen
menu on the
Language, Set Time
Setup
, and
screen and press the control
Configuration
LCD Light
screen, the
.
16
WARNING
Do not perform repair or maintenance when the device is operating. The patient can undergo treatment by using the methods described in this chapter, or view the sleep
quality and sleep report the previous day.
4.1 Treatment Steps
4 Routine Use
4 Routine Use
Check whether the tube is damaged or contains foreign bodies each time before using the ventilator. If the tube is damaged or contains foreign bodies, clean or replace the tube.
The ventilator can be used only after completion of treatment parameter settings (including detailed treatment settings, ramp settings, and humidity level settings) by a licensed physician or under the instruction of a licensed physician.
1. Connect the ventilator based on section
2. Lie down on a bed and adjust the tube so that the tube can move freely when you turn over during sleep.
3. Put on the mask and tie the headbands and adjust them until you have a comfortable fit and there are no air leaks when you breathe.
4. Press the button to start treatment. If the Smart Start function is enabled (see Figure 4-1), you can take two deep breaths and the
ventilator will automatically start treatment. See 3.4.1 Detailed Treatment Settings.
Figure 4-1 Enabling the
2.3 Installation
Smart Start function
.
5. Adjusting the humidity level will help to make breathing more comfortable. For details, see 3.2 Humidity Level.
17
6. After using the ventilator, press to stop therapy.
Parameter
Description
Period
This parameter records the patient's sleep quality the previous night.
Usage
This parameter records the time when the patient uses the ventilator the previous night.
AHI
This parameter records the patient's AHI index.
7. Put off the mask and headbands and unplug the power cord to shut down the ventilator.
In the case of power failure or in the unlikely event of fault conditions, take off the mask to avoid inhaling the air you have exhaled previously.
In the case of power failure, the device will shut down automatically. After power restoration, the device will automatically start up and return to the initial interface (Figure 2-1).
Do not block the air inlet and outlet of the ventilator with any bed cover, curtain, or other objects.
Always keep the air outlet of the humidifier lower than the tube and mask to prevent ingress of water inside the tube.
4.2 Sleep Report
4 Routine Use
Press the button to enter the and sleep report.
4.2.1 Sleep Quality
Sleep Quality
screen, which displays the patient's sleep quality
18
4.2.2 Sleep Report
Parameter
Description
Period
This parameter specifies the period of a sleep report, which may be one day, one week, one month, three months, six months, or one year.
Days>4hrs
This parameter records the number of days when the ventilator is used for more than 4 hours. For example, the value
10/20
indicates that the number of device usage days is 20, with 10 days of device usage exceeding 4 hours per day.
Avg. Usage
This parameter records the average hours of device usage every day.
Used Hrs
This parameter records the total hours of device usage.
4 Routine Use
19
5 Cleaning and Maintenance
5 Cleaning and Maintenance
WARNING
Unplug the CPAP Ventilator before cleaning.
Clean the mask and air tubing based on the instruction of the manufacturer and determine the cleaning period.
Do not perform repair or maintenance when the device is operating.
Do not clean the ventilator and accessories with any abrasive cleaner, alcohol, chlorine-bearing compound, acetone, or any other solvents.
Over-warming of materials may cause material pre-aging.
Wash all accessories and parts of the humidifier in clean water after cleaning with a detergent. Wipe all parts with a lintless cloth to prevent calcareous sediments accumulation.
The CPAP Ventilator and accessories must be cleaned regularly under normal usage to prevent the user from contracting respiratory tract infection.
5.1 Daily Cleaning
The mask and the water tub of the humidifier must be cleaned daily.
WARNING
Ensure that the ventilator is unplugged and the water tub of the humidifier is cool before cleaning.
5.1.1 Cleaning the Mask
Carefully clean the mask with a mild detergent.
Carefully clean the silica gel pad that is in close contact with skin during normal usage.
Check whether the vent holes of the mask are unblocked.
Rinse the mask in clean water and wipe the mask with a clean cloth to prevent stains.
Suspend the mask and air dry. Avoid direct sunlight on the mask or place the mask on a radiator.
20
The shelf life of mask is 24 months.
It is suggested to change the mask after every 6 months use.
5 Cleaning and Maintenance
5.1.2 Cleaning the Water Tub of the Humidifier
It is recommended that water in the water tub be changed and the water tub be washed every day based on the following steps:
1. Switch off the ventilator and keep it off for 15 minutes for cooling down.
2. Open the cap of the humidifier by pressing the [OPEN] button.
3. Take out the water tub and discard any remaining water.
4. Wash all parts in the dishwasher or a solution of warm water (not higher than 50oC) and a mild dishwashing detergent.
5. Rinse the water tub with clean water and allow to air dry.
6. Fill the water tub and close the cover. Inspect the water tub for any leak or damage. Replace the water chamber if any damage is present.
Prevent ingress of water inside the ventilator during washing.
5.2 Weekly Cleaning
5.2.1 Cleaning the Air Filter
The air filter of the device is not washable. It is suggested to be changed after 3~6 months use. Please contact your local agent for purchasing.
The standby air filters should avoid direct sunlight, be away from wet or cold site, otherwise they will be damaged.
5.2.2 Enclosure
Wipe the outside of the CPAP Ventilator with a cloth slightly dampened with water. Use a dishwashing detergent when necessary.
Before using the ventilator, ensure that the enclosure is thoroughly dry and there are no moisture ingress inside the ventilator.
5.2.3 Cleaning the Air Tubing
1. Disconnect the tube from the ventilator and mask.
2. Clean the tube with a detergent and rinse the tube in clean water.
21
5 Cleaning and Maintenance
3. Air dry the tube in a shady and cool place until the tube is thoroughly dry.
The shelf life of air tubing is 3 years.
It is suggested to change the air tubing after every one year use.
5.2.4 Cleaning the Headbands
1. Remove the headbands from the mask.
2. Wash the bands by hand in water at about 30oC or in a solution of warm water containing mild soap liquids. (Because the headbands may be decolored, wash the bands separately for the first time.)
3. Spin-dry the headbands at low speeds or drain the headbands.
Do not iron the headbands; otherwise, the magic tapes of the bands may be damaged.
5.3 Disinfection
Generally there is unnecessary to sterilize the device if you follow the right cleaning instructions. When the humidifier was contaminated or used in clinical, you can get standard disinfectants from a pharmacist to do the disinfection.
Disinfectants will damage the device’s surface and shorten its life. Therefore, for the specific
disinfectant suitable materials and instructions , you should follow the manufacturer's advise.
After cleaning with disinfectants, wash all parts of the device in close with the patient in clean water, such as the mask, headbands and tube, to keep skin away from infections
After disinfection, check if there are any parts damaged traces. If so, please replace the defective parts.
5.4 Transfer the Device
When the device is transferred to another patient, for health reason, it is recommended that you replace the parts in contact with the patient, such as the mask, headbands, water tub, tub and air filter.
22
6 Service and Repair
6 Service and Repair
The CPAP Ventilator should be maintained by the user. Check the following items before using the ventilator:
Check whether the air tubing and mask are sealed
Check whether the treatment pressure is generated and appears on the display screen
Check whether the water inside the humidifier is warmed up.
If the CPAP Ventilator is faulty, or unexpected operation or events occur, contact Dymind Biotech or your device supplier. Repair can only be done by an authorized engineer.
Long-term usage and free repair service of the CPAP Ventilator are possible only when the user complies with the security and cleaning & maintenance guidelines of the ventilator.
23
7 Troubleshooting
Problem
Possible Cause
Solution
You feel mucosa drying in nasal cavity, nose coldness or congestion, have a running nose, or catch a cold.
The symptoms are the nose's responses to the airflow from the ventilator or cold symptoms. Nose coldness is caused by the fast-flowing air, stimulating the nasal mucosa and resulting in nose dryness or swelling.
Increase the humidity level of the heated humidifier.
Consult your physician. Do not stop treatment unless advised by your doctor.
You feel dryness in the oral cavity or throat.
You may sleep with your mouth open.
Wrap a fixing band around your lower jaw.
Consult your physician and consider the use of a full-face mask.
OSA occurs multiple times during a day.
You have pricking eyes.
The mask is not fixed properly, causing air leaks.
The size and model of the mask are incorrect.
Shorten the distance between the prefrontal frame of the mask and your forehead.
Contact your device supplier and select a mask of a different model. Insert fillers into the mask when necessary.
The skin in the contact position between your face and the mask reddens.
The mask pad (the soft part inside the mask) hardens.
The mask is too tight.
The distance between the prefrontal frame of the mask and your forehead is incorrect.
The size of the mask is incorrect.
You are allergic to the mask materials.
Replace the mask or mask pad.
Loosen the mask and headbands.
Try different distances.
Contact your device supplier and select a different mask.
Use a fixing material in the contact position between your face and the mask and consult your physician and device supplier, or use a rubber-free mask.
Ingress of water inside the mask.
If the heated humidifier is used, the temperature difference between the air tubing and surrounding air will cause
Reduce the temperature level of the heated humidifier or increase the temperature of the surrounding environment.
7 Troubleshooting
The table below lists common problems you may have with the CPAP Ventilator and possible solutions to those problems. If none of the corrective actions solve the problem, contact your physician or device supplier.
24
7 Troubleshooting
Problem
Possible Cause
Solution
condensation.
Always keep the air outlet of the humidifier lower than the tube and mask to prevent ingress of water inside the tube.
You feel pain in the nose, paranasal sinuses, or eyes.
Nasosinusitis or otitis media
Contact your physician immediately.
You feel uncomfortable because the treatment pressure is not suitable.
The user will feel uncomfortable when the treatment pressure is higher than 13 hPa. In some situations, however, it is necessary to set the treatment pressure over 13 hPa to prevent OSA.
It may take up to four weeks to adapt to the treatment pressure. Try to relax yourself when using the ventilator. Breathe through your nose and keep your month closed.
If the problem persists, contact your physician.
The noise level of the Ventilator is too high.
The air tubing is connected incorrectly.
The humidifier and host are not connected tightly.
Connect the air tubing to the correct interface of the host.
Reconnect the humidifier to the host.
The inhaled air is too hot.
The air inlet or air filter is blocked.
The ventilator is too close to a wall, curtain, or other objects, obstructing air circulation.
Clean or replace the air filter (see section 4.2 "Weekly Cleaning") and clean the air inlet.
Place the ventilator in a place with good air flow and in a distance of at least 20 cm away from a wall, curtain, or other objects.
25
Appendix A Specifications
Dimensions
270 mm × 162 mm × 106 mm
Weight
1.6 kg
Power supply
100–240 V AC, 50/60 Hz; 24 V DC
Air outlet
22 mm conical air outlet
Data storage
microSD card, data management software
Degree of protection against electric shock
Class II, type BF Applied Part, the mask is applied part
Ingress protection
IP21 – Drip-Proof, Vertical
Work Mode
CPAP, APAP
Sound Pressure Level
< 30 dB, when the ventilator is working at the pressure of 10 hPa (According to ISO 17510-1:2002)
Environmental conditions
-
During usage
During transportation or storage
Ambient temperature
5oC to 35oC
–20oC to +60oC
Relative humidity
15%~80% (non-condensing)
10%~93% (non-condensing)
Atmospheric pressure
86~106 kPa
50~106 kPa
Altitude compensation
Automatic altitude compensation
Pressure compensation
Automatic air-leak pressure compensation
Expected service life
More than 5 years
A.1 Basic Specification
7 Troubleshooting
26
Appendix A Specifications
Pressure Range
4~20hPa (display resolution 0.1hPa, interval 0.2 hPa)
Pressure Measurement Tolerance
±0.5hPa or ±4% of measured value
Flow Measurement Tolerance
±5 L/min or 10% of measured value, whichever is greater
Ramp Time
0~60min, ±10%
Pressure (hPa)
Maximum Flow (L/Min)
4
30 8 35
12
40
16
45
20
55
Pressure (hPa)
Maximum dynamic pressure variation (hPa)
10 bpm
15 bpm
20 bpm
4
≤1.2
≤1.2
≤1.3
8
≤1.3
≤1.5
≤1.7
12
1.3
1.5
1.7
16
1.3
1.5
1.7
20
1.3
1.5
1.7
A.2 Technical Specification
Pressure and Flow Rate
Maximum Single Fault Steady Pressure
The pressure between the patient and the tubing is no more than 30hPa under single failure state.
Maximum Flow at Set Pressures
When the more than the respective standard resistance with 4 mm internal diameter, 40 mm length and outlet angle of 45°.)
Pressure
is set as below, the average flow from the patient connection port should be no
Maximum Flow
Maximum Dynamic Pressure Variation
It will increase the range of pressure if you open the
as below. (The patient connection port is connected to a
function.
Xlief
27
7 Troubleshooting
28
Appendix B Terms
A
AHI
Apnea Hypoventilation Index
APAP
Automatic Continuous Positive Airway Pressure
C
COPD
Chronic Obstructive Pulmonary Disease
CPAP
Continuous Positive Airway Pressure
E
ETS/E-sensitivity
Expiratory Trigger Sensitivity
I
IFR/ I-rate
Inspiratory Flow Rate
ITS/I-sensitivity
Inspiratory Trigger Sensitivity
O
OSA
Obstructive Sleep Apnea
OSAS
Obstructive Sleep Apnea Syndrome
Appendix B Terms
29
7 Troubleshooting
Guidance and manufacture’s declaration – electromagnetic emission
The CPAP Ventilator is intended for use in the electromagnetic environment specified below. The customer of the user of the CPAP Ventilator should assure that it is used in such an environment.
Emission test
Compliance
Electromagnetic environment – guidance
RF emissions CISPR 11
Group 1
The CPAP Ventilator use 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 emission CISPR 11
Class B
The CPAP Ventilator is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2
Class A
Voltage fluctuations/ flicker emissions
IEC 61000-3-3
Complies
Appendix C EMC Requirements
This product needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided, and this unit can be affected by portable and mobile RF communications equipment.
Do not use a mobile phone or other devices that emit electromagnetic fields, near the unit. This may result in incorrect operation of the unit.
This unit has been thoroughly tested and inspected to assure proper performance and operation!
This machine should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, this machine should be observed to verify normal operation in the configuration in which it will be used
WARNING
The use of ACCESSORIES, transducers and cables other than those specified, with the exception of transducers and cables sold by the MANUFACTURER of the Ventilator as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the ME EQUIPMENT or ME SYSTEM.
30
Appendix C EMC Requirements
Guidance and manufacture’s declaration electromagnetic immunity
The CPAP Ventilator is intended for use in the electromagnetic environment specified below. The customer or the user of CPAP Ventilator should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment ­guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
±6 kV contact ±8 kV air
±6 kV contact ±8 kV air
Floors should be wood, concrete or ceramic tile. If floor are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient/burst
IEC 61000-4-4
±2 kV for power supply lines
±2kV for power supply lines
Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC
61000-4-5
± 1 kV line(s) to line(s)
±1 kV differential mode
Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines
IEC 61000-4-11
<5% UT (>95% dip in UT) for 0.5 cycle
40% UT (60% dip in UT) for 5 cycles
70% UT (30% dip in UT) for 25 cycles
<5% UT (>95% dip in UT) for 5 sec
<5% UT (>95% dip in UT) for 0.5 cycle
40% UT (60% dip in UT) for 5 cycles
70% UT (30% dip in UT) for 25 cycles
<5% UT (>95% dip in UT) for 5 sec
Mains power quality should be that of a typical commercial or hospital environment. If the user of the
Ventilator
requires continued operation during power mains interruptions, it is recommended that the
Ventilator
be powered from an uninterruptible power supply or a battery.
Power frequency (50Hz/60Hz) magnetic field IEC 61000-4-8
3A/m
3A/m
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
NOTE
: UT is the a.c. mains voltage prior to application of the test level.
31
Appendix C EMC Requirements
Guidance and manufacture’s declaration – electromagnetic immunity
The CPAP Ventilator is intended for use in the electromagnetic environment specified below. The customer or the user of CPAP Ventilator should assure that it is used in such an environment.
Immunity test
IEC 60601 test
level
Compliance
level
Electromagnetic environment - guidance
Conducted RF IEC 61000-4-6
3 V
rms
150 kHz to 80 MHz
3 Vrms
Portable and mobile RF communications equipment should be used no closer to any part of the CPAP Ventilator, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
80 MHz to 800 MHz 800 MHz to 2.5 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 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:
Radiated RF IEC 61000-4-3
3 V/m 80 MHz to 2.5 GHz
3 V/m
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 CPAP Ventilator is used exceeds the applicable RF compliance level above, the CPAP Ventilator should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the CPAP Ventilator.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
32
Appendix C EMC Requirements
Recommended separation distances between portable and mobile RF communications equipment and the Ventilator .
The CPAP Ventilator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the CPAP Ventilator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the CPAP Ventilator as recommended below, according to the maximum output power of the communications equipment.
Rated
maximum
output power of
transmitter
(W)
Separation distance according to frequency of transmitter
(m)
150 KHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
0.01
0.117
0.117
0.233
0.1
0.369
0.369
0.738
1
1.167
1.167
2.333
10
3.689
3.689
7.379
100
11.667
11.667
23.333
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (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.
33
Appendix D Packing List
No.
Name
Quantity
1
Host
1
2
Humidifier
1
3
Air tubing
1 4 Nasal mask
1
5
Air Filter
2
6
Power adapter
1 7 MicroSD card
1
8
Ventilator User Manual
1
9
Carrying case
1
10
Power cable
1
11
Ventilator Quick Start Guide
1
12
Ventilator Packing List
1
Appendix D Packing List
34
P/N: 65020001AY (1.0)
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