User Guide

CPAP/Auto CPAP/BIPAP ST25 /

ST30
User Guide
User Guide

Product
The DS-5 is VentMed's Positive Airway Pressure (CPAP) device.
The DS-6 is VentMed's Auto-adjusting Pressure (Auto CPAP) device.
The DS-7 is VentMed's Bilevel Positive Airway Pressure ST25 (BIPAP ST25)
device. The DS-8 is VentMed's Bilevel Positive Airway Pressure ST30 (BIPAP
ST30) device.
CPAP mode provide same inspiratory and expiratory therapy pressure in one
breathing cycle, Bilevel mode provide different inspiratory and expiratory therapy
pressure.
WARNING
Read this entire guide before using the device.

CAUTION
In the US, Federal law restricts this device to sale by or on the order of a physician.
Indications for use
The VentMed CPAP and Auto CPAP is indicated for the treatment of obstructive
sleep apnea (OSA) in patients weighing more than 66 lb (30 kg). The humidifier is
integrated in device.
The VentMed BIPAP ST25 and BIPAP ST30 are indicated for the treatment of
obstructive sleep apnea (OSA)/ central sleep apnea (CSA)/ mixed sleep apnea
(MSA) in patients weighing more than 66 lb (30 kg). The humidifier is integrated
in device.

Adverse effects
You should report severe headache, unusual chest pain or increased breathlessness
to your prescribing physician. An acute upper respiratory tract infection may
require temporary discontinuation of treatment.
The following side effects may arise during the course of therapy with the device:
drying of the nose, mouth, or throat
nosebleed
bloating
ear or sinus discomfort
eye irritation

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User Guide
skin rashes.

Contraindications
Positive airway pressure therapy may be contraindicated in some patients with the
following pre-existing conditions:
pneumothorax
dehydration
severe bullous lung disease
pathologically low blood pressure
cerebrospinal fluid leak, trauma recent, or cranial surgery.

Packing list of the device

Device with integrated humidifier

Water tank
Power supply unit
Travel bag
Measuring cup
Contact your care provider for a range of accessories available for use with the
device including: Air tubing/Air filter/Mask
Use the mask/air tubing that complies with ISO17510/ISO80601-2-70/EN
ISO10993.
WARNING: Failure to use a mask or accessory that minimizes rebreathing of
carbon dioxide or permits spontaneous breathing can cause asphyxiation.

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About device

1 Air outlet 5 Water tank

2 SD card slot 6 Water tank open switch
3 Power inlet 7 Screen
4 Air filter cover 8 Start/Stop button: Press to start/stop therapy

About the control panel

Start/Stop button Press to start/stop therapy.

Up button Press to select previous item.
Down button Press to select next item.
Enter button Press to enter the selected item.
Different icons may be displayed on the screen at different times including:

Machine is working Ramp time

Humidifier Level SD Card

Setup

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User Guide

CAUTION
Do not overfill the water tank as water may enter the device and air
tubing.
1. Place the device on a stable level surface.
2. Plug the power connector into the rear of the device. Connect one end of the
power cord into the power supply unit and the other end into the power outlet.
3. Connect the air tubing firmly to the air outlet located on the rear of the device.
4. Open the water tank cover and fill it with distilled water up to the maximum
water level mark. Do not fill hot water in the water tank.
5. Close the water tank cover.
6. Connect the free end of the air tubing firmly onto mask. For detailed
information, read the mask user guide.
7. Physician should ensure the compatibility of the equipment and all of the parts
and accessories used to connect to the patient before use; should ensure that the
therapeutic pressure settings were determined for the patient individually with
the configuration of the equipment to be used, including accessories; and should
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User Guide
periodically reassess the setting(s) of the therapy for effectiveness.
8. The equipment must not be covered or positioned in such a way that the
operation or performance of the equipment is adversely affected.

Starting therapy
1. Fit your mask.
2. Press Start/Stop button.
3. You will know that therapy is on when the air fan icon is rotated.
The current treatment pressure is shown in white words.
During ramp time the pressure is gradually increasing and you will see a blue
triangle icon on the screen once the prescribed pressure is reached.
The screen will go black automatically after a short period of time. You can press
any button to turn it back on.

Stopping therapy
1. Remove mask.
2. Press Start/Stop button, therapy will stop automatically after a few seconds.
The Sleep Report now gives you a summary of therapy session.

Compliance/Week Avg: H--Indicated the number of hours of therapy you received

in one week.

H Today--Indicated the number of hours of therapy you received today.

Compliance/Month: H--Indicated the number of hours of therapy you received in
one month.

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User Guide

Sleep Report

1. In work interface, press Up or Down button to check sleep report date and
waveform.

W M: Work Mode Press: Therapy Pressure T V: Tidal Volume

Insp T: Inspiratory Time M V: Minute Volume Exp T: Expiratory
Time
Leak: Air Leakage BPM: Breaths Per Minute

My Options

The device has been set up for your needs by your care provider, but you may want
to make small adjustments to make your therapy more comfortable.
Highlight My Options and press Up/Down button to see current setting. You can
personalize your options.

Ramp Time

Designed to make the beginning of therapy more comfortable, Ramp Time is the
period during which the pressure increases from a low start pressure to the
prescribed treatment pressure. You can set Ramp Time from 0 to 60minutes.

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User Guide

To adjust Ramp Time:

1. In Options, press enter button to highlight Ramp Time.

2. Press up/down button to adjust the ramp time to your preferred setting.
3. Press enter button to save the change.

Humidity Level

The humidifier moistens the air and is designed to make therapy more comfortable.
Can set the Humidity Level to off (0) or between 1 and 5, where 1 is the lowest
humidity setting and 5 is the highest humidity setting.
To adjust the Humidity Level:

1. In Options, press enter button to highlight Humidity Level.

2. Press up/down button to adjust humidity level.
3. Press enter button to save the change.

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Work Mode

CPAP mode for DS-5 CPAP.

CPAP, Auto mode for DS-6 Auto CPAP.
CPAP, Auto, S, T, ST mode for DS-7 BIPAP ST25.
CPAP, Auto, S, T, ST, APCV mode for DS-8 BIPAP ST30.

To Unlock Woke Mode parameters

1. Work Mode parameters will be locked automatically after setting in 15

minutes.
2. Long press enter button over 5 seconds to highlight the column to unlock.
To adjust the working pressure

To adjust the working pressure

1. In work mode CPAP, press enter button to highlight Pressure. Press up/down
button to adjust working pressure. You can set pressure 4-20 cmH2O for CPAP
mode.
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2. In work mode Auto CPAP, press enter button to highlight Pressure. Press
up/down button to adjust Max and Min working pressure. You can set pressure
4-20 cmH2O for Auto CPAP mode.

3. In work mode S, T, ST, press enter button to highlight IPAP (Inspirate Positive
Airway Pressure) . Press up/down button to adjust IPAP working pressure. You
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User Guide VentMed
can set pressure 4-25 cmH2O for DS-7 BIPAP ST25 and 4-30 cmH2O for DS-8
BIPAP ST30

4. In work mode S, T, ST, press enter button to highlight EPAP (Expirate Positive
Airway Pressure). Press up/down button to adjust EPAP working pressure.
You can set pressure 4-20 cmH2O for DS-7 BIPAP ST25 and DS-8 BIPAP
ST30.
Attention: Inspirate pressure must be higher than expirate pressure.

To adjust Backup Rate

Designed to set device inspirate and expirate therapy times in 1 minute. You can
set 5-50bpm in mode T & ST.
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TO adjust I/E Rate

Designed to set device different inspirate and expirate therapy percentage in a

whole therapy duration. You can set 10%-80% in mode T & ST.

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TO adjust Inspirate Trigger

You can set 1-5 in mode S/T/ST, “1” is the most sensitive, “5” is the slowest.

TO adjust Expirate Level

You can set 1-5 in mode S & ST, “1” is the most sensitive, “5” is the slowest.

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TO adjust Inspirate Sensitivity

You can set 1-5 in mode S & ST, “1” is the most sensitive, “5” is the slowest.

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To set APCV mode

In APCV mode, you can set IPAP/EPAP/Backup Rate/Inspirate Trigger/ Expirate

Level/Inspirate Sensitivity, the adjust process is same as ST mode.

To adjust Inspirate Duration

You can set from 0.5 seconds to 4 seconds.

TV. V. Switch

Designed to set target tidal volume ON or OFF.

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User Guide VentMed

To adjust TV.V.

Designed to set target tidal volume, you can set from 200ml to 1200ml.

To adjust Max. IPAP

Designed to set maxium IPAP (Inspirate Positive Airway Pressure), you can set
from 10 cmH2O to 30 cmH2O.

To adjust Min. IPAP

Designed to set minimum IPAP (Inspirate Positive Airway Pressure), you can set
from 4 cmH2O to 20 cmH2O.

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Auto ON

Designed to make the device start automatically in a while after you wear mask.

Auto OFF

Designed to stop the device work automatically in 10seconds after you take mask
away.

Time Setting

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Pressure Relief

The device already automatically set EPR (Expiratory Pressure Relief) function;
you may find it easier to breathe out. This can help you get used to therapy.
Can set the expirtory pressure relief Level to off (0) or between 1 and 3, where 1 is
the lowest expiratory pressure relief and 3 is the highest setting.

Caring for device

It is important that you regularly clean the device to make sure device work
normally. The following sections will help you with disassembling, cleaning,
checking and reassembling the device.

Disassembling

1. Open the water tank cover, take water tank away from the device.
2. Open the water tank and discard any remaining water.
3. Hold the cuff of the air tubing and gently pull it away from the device.

Cleaning

Clean the device weekly as described. Refer to the mask user guide for detailed
instructions on cleaning your mask.
1. Wash the water tank and air tubing in warm water using mild detergent. Do not
wash in a dishwasher or washing machine.
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2. Rinse the water tank and air tubing thoroughly and allow to dry out of direct
sunlight and/or heat.
3. Wipe the exterior of the device with a dry cloth.

Checking

Regularly check the water tank, air tubing and the air filter for any damage.
1. Check the water tank:
Replace it if it is leaking or has become cracked, pitted or cloudy.
Replace it if the seal is cracked or torn.
Remove any white powder deposits using a solution of one part household
vinegar to 10 parts water.
2. Check the air filter and replace it at least every six months. Replace it more
often if there are any holes or blockages by dirt or dust.

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User Guide VentMed
To replace the air filter:

Open the air filter cover and remove the old air filter. The air filter is not
washable or reusable.
Place a new air filter then close the air filter cover.
Make sure the air filter is fitted at all times to prevent water and dust from
entering the device.
3. Check the air tubing and replace it if there are any holes, tears or cracks.

Reassembling

When the water tank and air tubing are dry, can begin to reassemble the parts.
1. Connect the air tubing firmly to the air outlet located on the rear of the device.
2. Fill the water tank with distilled room temperature water up to the maximum
water level mark.
3. Put water tank into the device. Close the water tank cover.
4. Connect the free end of the air tubing firmly onto the mask.

Therapy data

The device records therapy data for you and your care provider so they can view
and make changes to your therapy if required. The data is recorded via a SD card.
You can send SD card to your care provider by mail. When instructed by your care
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provider, remove the SD card.
Do not remove the SD card from the device when the device is working.

To remove the SD card:

1. Stop the device.

2. Push in the SD card to release it. Remove the SD card from the device.
Place the SD card in the protective folder and send it back to your care provider.
Note: The SD card should insert in correct, should not be used for any other
purpose.

Traveling

You can take this device with you wherever you go. Just keep the following in
mind:
Empty the water tank and put it into the device.
Make sure you have the appropriate power cord for the region you are traveling
to. For information on purchasing, contact your care provider.
Use the travel bag provided to prevent damage to the device.
If you are using an external battery, should turn off the humidifier in order to
maximize the life of your battery. Do this by turning the Humidity Level to
Off.

CAUTION
Do not use the device with water in the water tank on a plane due to the risk of
inhalation of water during turbulence.

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Troubleshooting

If you have any problems, have a look at the following troubleshooting topics. If
you are not able to fix the problem, contact your care provider or VentMed. Do not
try to open the device.
Problem/possible cause Solution
Air is leaking from around mask Make sure mask is fitted correctly and
Mask may be fitted incorrectly. firmly. Read your mask user guide for
detailed information.
Air pressure in mask seems too high
(it feels like getting too much air) Use the Ramp Time option.
Ramp may be turned off.
Air pressure in mask seems too low
(it feels like I am not getting enough
air) Wait for air pressure to build up or turn
Ramp may be in progress. Ramp Time off.
My water tank is leaking
Water tank may not be assembled Check for damage and reassemble the
correctly. water tank correctly.
Water tank may be damaged or Contact your care provider for a
cracked. replacement.
Nose is feeling dry or blocked
Humidity level may be set too low. Adjust the Humidity Level.
Screen is black
Backlight on the screen may have Press any button to turn it back on.
turned off. It turns off automatically Connect the power supply and make sure
after a short time. the plug is fully inserted.
Power may not be connected.
Have stopped therapy, but the device Device blows a small amount of air in
is still blowing air order to avoid condensation in the air
Device is cooling down. tubing. It will stop automatically after 20
minutes.

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Problem/possible cause Solution

High leak detected, check water

tank, tank seal or water tank cover
Water tank may not be inserted Make sure the water tank is correctly
properly. inserted.
Water tank seal may not be inserted Open the water tank and make sure that
properly. the seal is correctly inserted.
Droplets of water on nose, in the
mask and air tubing
Humidity level may be set too high. Adjust the Humidity Level.
Mouth is very dry and Increase the Humidity Level.
uncomfortable You may need a chin strap to keep your
Air may be escaping through mouth. mouth closed or a full face mask.
High leak detected, connect your Make sure the air tubing is firmly
tubing connected at both ends.
Air tubing may not be connected Make sure mask is fitted correctly. See
properly. your mask user
Mask may be fitted incorrectly. guide for fitting instructions or use the
Mask Fit function to check your mask fit
and seal.
Tubing blocked, check your tubing Check the air tubing and remove any
Air tubing may be blocked. blockages.
SD card error
SD card may not be inserted correctly. Power off the device, remove and
reinsert the SD card.
Air filter blocked Check the air filter and replace it if there
are any blockages.
Water in the air tubing Empty the water from the air tubing.
Disconnect the power
supply and then reconnect it to restart
the device.
All other error messages Contact your care provider. Do not open
the device.

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Reassembling parts

Water tank is designed to easily come off in order to avoid damage to the parts or
the device. You can easily reassemble them as described below.

To insert the water tank seal:

1. Place the seal into bottom water tank.
2. Press down along all edges of the seal until it is firmly in place.

To reassemble the water tank:

1. Insert both up water tank into bottom water tank and sealed both sides.

General warnings and cautions

WARNING
Make sure that you arrange the air tubing correctly so that it will not twist
around the head or neck.
Keep the power cord away from water source or hot surfaces.
Make sure the power cord and plug are in good condition and the device is not
damaged.
Do not open or modify the device. Repairs and servicing should only be
performed by your care provider.
Beware of electrocution. Do not immerse the device, power supply or power
cord in water. If liquids are spilled into or onto the device, unplug the device
and let the parts dry. Always unplug the device before cleaning and make sure
that all parts are dry before plugging it back in.
If you notice any unexplained changes in the performance of the device, if it is
making unusual sounds, if the device or the power supply are dropped or
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User Guide VentMed
mishandled, or if the enclosure is broken, discontinue use and contact your care
provider.
Supplemental oxygen must not be used while smoking or in the presence of an
open flame.
Always make sure that the device is turned on and airflow generated before the
oxygen supply is turned on. Always turn the oxygen supply off before the
device is turned off, so that unused oxygen does not accumulate within the
device enclosure and create a risk of fire.
Sources of oxygen must be located more than 1 m from the equipment to avoid
the risk of fire and burns.
Do not perform any maintenance tasks while the device is in operation.

CAUTION
Use only compliant parts and accessories with the device. Non-compliant parts
may reduce the effectiveness of the treatment and/or damage the device.
Be careful not to place the device where it can be bumped or where someone is
likely to trip over the power cord.
Use only VentMed masks recommended by VentMed or by the prescribing
doctor with this device. Fitting the mask without the device blowing air can
result in rebreathing of exhaled air. Make sure that the mask vent holes are kept
clear and unblocked to maintain the flow of the fresh air into the mask.
Keep the device dry, clean and clear of anything (eg, clothes or bedding) that
could block the air inlet or cover the power supply unit.
Do not place the device on its side as water might get into the device.
Do not block the air tubing and/or air inlet of the device while in operation as
they could lead to overheating of the device.
Incorrect system setup may result in incorrect mask pressure reading. Ensure
the system is correctly set up.
Make sure that the water tank is empty before transporting the device.
When use the humidifier, please always place the device on a level surface
lower than your head to prevent the mask and air tubing from filling with water.

Leave the water tank to cool for ten minutes before handling to allow the water
to cool and to make sure that the water tank is not too hot to touch.
Do not use bleach, chlorine, alcohol, or aromatic-based solutions, moisturizing
or antibacterial soaps or scented oils to clean the device, the water tank or air
tubing. These solutions may cause damage or affect the humidifier

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performance and reduce the life of the products.
Periodically reassess the setting(s) of the therapy for effectiveness.

Technical specifications

Type Item Specifications

60W power supply AC input range 100–240V~, 50–60Hz,
unit (Only use 2A maximum, Class II
with IEC60601-1 DC output 24V 2.5A
approved adaptor)
Operating temperature +41°F to +95°F (+5°C to
+35°C)
Note: The air flow for breathing
produced by this therapy
device can be higher than the
Environmental temperature of the room.
conditions Under extreme ambient
temperature conditions
(104°F/40°C) the device
remains safe.
Operating humidity: 10 to 95% relative humidity,
non-condensing
Operating altitude Sea level to 8,500' (2,591 m);
air pressure range 1013 hPa to
738 hPa
Storage and transport -4°F to +140°F (-20°C to +60°C)
temperature
Storage and transport humidity 5 to 95% relative humidity,
non-condensing
Electromagnetic The VentMed device complies
compatibility with all applicable
electromagnetic compatibility
requirements (EMC) according
to IEC60601-1-2:2014, for
residential, commercial and

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light industry environments

Class II (double insulation),

IEC
60601-1:2005+A1: Type BF, Ingress protection
2012 classification IPX1.
Sensors Pressure sensor Internally located at device
outlet, analog gauge
pressure type, 0 to 40 cm
H2O
Flow sensor Internally located at device
outlet, analog gauge flow
type, 50 to +200 L/min
Maximum single Device will shut down in
fault steady the presence of a single fault if
pressure the steady state pressure
exceeds: 35 cm H2O for more
than 1 sec.
Sound Pressure level measured 53 dBA with uncertainty of
according to ISO 80601-2-70 2 dBA under background
(CPAP mode)Declared sound level 36 dBA
dual-number noiseemission A-weighted sound power level
values in accordance with ISO is 61dba under background
4871:1996. sound level 36dBA
Dimensions (H x W x D): 280 mm x 140 mm x 95 mm
Air outlet (complies with ISO 22 mm
5356-1:2004)
Physical-device Weight (device and water tank) 1.6kgs
and water tank Water capacity To maximum fill line
220 ML, minimum 100ML
Water tank - material Injection molded plastic
and silicone seal
Maximum heater plate 68°C
Temperature Cut-out 102°C
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Maximum gas temperature 41°C
Operating pressure DS-5 CPAP 4 to 20 cm H2O
range(IPAP) DS-6 Auto CPAP 4 to 20 cm H2O
DS-7 BIPAP ST25 4 to 25 cm H2O
DS-8 BIPAP ST30 4 to 30 cm H2O
Operating pressure DS-5 CPAP
range(EPAP) DS-6 Auto CPAP
4 to 20 cmH2O
DS-7 BIPAP ST25
DS-8 BIPAP ST30
Air Filter Material: Polyester non
woven fiber
Average arrestance: >75%
for ~7 micron dust
Device, power supply unit 5 years
Design life Water tank, air tubing 6 months
Notes:
Manufacturer will provide circuit diagrams, component part lists, descriptions,
calibration instructions to assist to service personnel in parts repair.
Manufacturer reserves the right to change specifications without notice.
The temperature and relative humidity settings displayed are not measured value
Do not use electrically conductive or antistatic air tubing.

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Displayed values
Value Range Display resolution
Pressure sensor at air DS-5 CPAP 0.1 cmH2O
outlet: Mask pressure DS-6 Auto CPAP 0.1cmH2O
DS-7 BIPAP ST25: 4–25 0.1 cmH2O
cmH20 0.1 cmH2O
DS-8 BIPAP ST30: 4-30
cmH2O

Value Accuracy
Value Accuracy
Static Airway Pressure ±0.5cmH2O + 4% of the set pressure
measurement: Mask
pressure
Dynamic Airway ±3cmH2O + 5% of the set pressure
Pressure
measurement(Both The percentage of each inspiratory and expiratory phase
Cpap/BIPAP): Mask to be taken into the calculation for determining the
pressure accuracy is (I/E=1:1)
Remark: Results are expressed at ATPD (Ambient Temperature and Pressure,
Dry).

Environmental information

This device should be disposed of separately, not as unsorted municipal waste. To

dispose of your device, you should use appropriate collection, reuse and recycling
systems available in your region. The use of these collection, reuse and recycling
systems is designed to reduce pressure on natural resources and prevent hazardous
substances from damaging the environment.
If you need information on these disposal systems, please contact your local waste
administration. The crossed-bin symbol invites you to use these disposal systems.
If you require information on collection and disposal of the device please contact
your care provider or VentMed.

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Symbols

The following symbols may appear on the product or packaging.

Indicates a warning or caution

Serial number

Type BF applied part

Maximum water level

Caution! Hot Surface. Do not touch.

Water proof Grade 1

Manufacturer

European Authorized Representative

Environmental information

Follow instructions before use

Direct current

Temperature limitation

Humidity limitation

Manufacturer Date

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Limited warranty

VentMed Ltd warrants that your VentMed product shall be free from defects in
material and workmanship from the purchase date for the period specified below.
Product Warranty period
Humidifier water tanks 90days
CPAP, BIPAP devices (including 2 years
external
power supply units)
Humidifier 2 years
This warranty is only available to the initial consumer. It is not transferable.
If the product fails under conditions of normal use, VentMed will repair or replace,
at its option, the defective product or any of its components.
This Limited Warranty does not cover:
a) Any damage caused as a result of improper use, abuse, modification or alteration
of the product;
b) Repairs carried out by any service organization that has not been expressly
authorized by VentMed to perform such repairs;
c) Any damage or contamination due to cigarette, pipe, cigar or other smoke.
Warranty is void on product sold, or resold, outside the region of original purchase.
Warranty claims on defective product must be made by the initial consumer at the
point of purchase.
This warranty replaces all other expressed or implied warranties, including any
implied warranty of merchantability or fitness for a particular purpose. Some
regions or states do not allow limitations on how long an implied warranty lasts, so
the above limitation may not apply to you.
VentMed shall not be responsible for any incidental or consequential damages
claimed to have resulted from the sale, installation or use of any VentMed product.

Further information
If you have any questions or require additional information on how to use the
device, contact your care provider.

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Technical Description Concerning

Electromagnetic
Immunity
Table 3: Guidance & Declaration - electromagnetic immunity

Guidance & Declaration — electromagnetic immunity

The models DS-5, DS-6, DS-7, DS-8 are intended for use in the electromagnetic
environment specified below. The customer or the user of the models DS-5, DS-6
DS-7, DS-8 should assure that It is used in such an environment.
Immunity IEC 60601 test Compliance level Electromagnetic environment
test level - guidance
Electrostatic ±8 kV contact ±8 kV contact Floors should be wood,
discharge ±2 kV, ±4 kV, ±2 kV, ±4 kV, concrete or ceramic tile. If
(ESD) ±8 kV, ±8 kV, ±15 kV air floors are covered with
lEC ±15 kV air synthetic material, the relative
61000-4-2 humidity should be at least 30
Electrical fast ±2kV for ±2kV for power Mains power quality should be
transient/burs power supply supply lines that of a typical commercial or
t lines ±1kV for hospital environment.
IEC ±1 kV for interconnecting
61000-4-4 Input/output cable
lines
Surge ±1 kV line to ±1 kV line to Mains power quality should be
lEC line line that of a typical commercial or
61000-4-5 ±2 kV line to hospital environment.
earth
Voltage dips, <5 % UT <5 % UT Mains power quality should be
short (>95% dip in (>95% dip in UT.) that of a typical commercial or
interruptions UT.) for 0.5 cycle hospital environment. If the
and for 0.5 cycle 40 % UT user of the models DS-5, DS-6,
voltage 40 % UT (60% dip in UT) DS-7, DS-8 require continued
variations on (60% dip in for 5 cycles operation during power mains
power supply UT) 70% UT (30% dip interruptions, it is
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User Guide VentMed
input for 5 cycles in UT) recommended that the models
lines 70% UT for 25 cycles DS-5, DS-6, DS-7, DS-8 be
IEC (30% dip in <5% UT (>95 % powered from an
61000-4-11. UT) dip in uninterruptible power supply or
for 25 cycles UT) for 5 sec a battery.
<5% UT
(>95 % dip in
UT)
for 5 sec
Power 30 A/m 30 A/m Power frequency magnetic
frequency fields should be at levels
(50- characteristic of a typical
60 Hz) location in a typical
magnetic commercial or hospital
field environment.
lEC
61000-4-8
NOTE UT is the a.c. mains voltage prior to application of the test level.

Annex A: Electromagnetic Compatibility

Information

Guidance and manufacturer's declaration - electromagnetic emissions– this

device is intended for use in the electromagnetic environment specified below. The

user of the device should ensure that it is used in such an environment.

Emissions Test Complianc Electromagnetic environment-guidance

e

The device users RF energy only for its

RF emissions internal function. Therefore its RF emissions

CISPR11 Group 1 are very low and are not likely to cause any

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interference in nearby electronic equipment.

RF emissions Class B This device is suitable for use in all

CISPR11 establishments, including domestic

Harmonic emissions Class A establishments and those directly connected to

IEC61000-3-2 the public low-voltage power supply network

Voltage fluctuation Conformity that supplies buildings used for domestic

/flicker emissions purposes.

IEC61000-3-3

Guidance and manufacturer's declaration - electromagnetic immunity – this

device is intended for use in the electromagnetic environment specified below. The
user of the device should make sure that it is used in such an environment.

Immunity test IEC60601 test Compliance level Electromagnetic

level environment-guidance

Floor should be wood,

Electrostatic ±6KV contact ±6KV contact concrete or ceramic tile. If

discharge ±8KV air ±8KV air floors are covered with

(ESD) synthetic material, the

IEC61000-4- relative humidity should be

2 at least 30%.

Electrical fast ±2KV for ±2KV for Mains power quality

transient / power supply lines power supply lines should be that of a typical
burst ±1KV for ±1KV for home or hospital.

IEC61000-4- input/output lines input/output lines

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 User Guide VentMed

±1K ±1KV Mains power quality

Surge differential mode differential mode should be that of a typical

IEC61000-4- ±2KV ±2KV home or hospital.

5 common mode common mode

Immunity test IEC60601 test level Compliance level Electromagnetic

environment-guidance

<5% UT <5% UT Main power quality

Voltage dips, (>95% dip in UT ), (>95% dip in UT ), should be that of a

short for 0.5 cycle for 0.5 cycle typical commercial or

interruptions hospital environment. If

and voltage 40% UT(60% dip in 40% UT(60% dip in the use of the device
variations on UT), for 5 cycles UT), for 5 cycles requires continued
power supply operation during power

input lines 70% UT 70% UT mains interruptions, it is

IEC61000-4-11 (30% dip in UT) (30% dip in UT) recommended that the

for 25 cycles for 25 cycles device be powered form

an uninterruptible

<5% UT <5% UT power supply or from a

(>95% dip in UT) (>95% dip in UT) battery.

for 5 s for 5 s

Power Power frequency

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 User Guide VentMed

frequency 3A/m 3A/m magnetic field shall be

(50/60Hz) typical level of power

magnetic field frequency magnetic

IEC61000-4-8 fields in hospital or

home environment.

Note: UT is the AC mains voltage prior to application of the test level.

Guidance and manufacturer's declaration - electromagnetic immunity – this

device is intended for use in the electromagnetic environment specified below. The

user of the device should make sure that it is used in such an environment.

Immunity IEC60601 test Compliance Electromagnetic

test level level environment-guidance

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User Guide VentMed

Portable and mobile RF

communications equipment should

be used no closer to any part of the

device, including cables, than the

recommended separation distance

calculated from the equation

application to the frequency of the

transmitter.

Recommended separation distance

d=1.2 √p

Conducted d=1.2√p 80MHz to 800MHz

RF 3Vrms 3Vrms d=2.3√p 800MHz to 2.5GHz

IEC61000-4 150kHz to

-6 80MHz

Immunity test IEC60601 test Compliance Electromagnetic

level level environment-guidance

Where P is the

Radiated RF 3V/m 3V/m maximum output

IEC61000-4-3 80MHz to power rating of the

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User Guide VentMed

2.5GHz transmitter in watts

(W) according to the

transmitter

manufacturer and d is
the recommended

separation distance in

meters (m).

Field strengths from

fixed RF transmitter,

as determined by an

electromagnetic site

survey, should be less

than the compliance

level in each

frequency range.

Immunity test IEC60601 test Compliance Electromagnetic

level level environment-guidance

Interference may

occur in the vicinity of

equipment marked

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User Guide VentMed

with the following

symbol:

Note 1: At 80MHz, the higher frequency range applied.

Note 2: These guidelines may not be applied in all situations. Electromagnetic

propagation is affected by absorption and reflection from structures, objects and

people.

a. Field strengths from fixed transmitters, such as base stations for radio (cellular /
cordless) telephones and land mobile radios, amateur radio, AM and FM radio

broadcast and TV broadcast cannot be predicted theoretically with accuracy. To

assess the electromagnetic environment due to fixed RF transmitters, an

electromagnetic site survey should be considered. If the measured field strength

in the location in which the device is used exceeds the applicable RF

compliance level above, the device should be observed to verify normal

operation. If abnormal performance is observed, additional measures may be

necessary, such as re-orienting or relocating the device.

b. Over the frequency range 150kHz to 80MHz, the field strengths should be less

than 3 V/m.

Maximum flow rate

1. CPAP

Pressure(cmH2O) Maximum flow rate(L/Min)

4 77

8 111

12 140

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User Guide VentMed

16 158

20 164

2. BIPAP

Pressure(cmH2O) Maximum flow rate(L/Min)

4 77

9 119

15 156

20 164

25 164

30 164

39
User Guide VentMed

Manufacturer:
Company: Hunan VentMed Medical Technology Co., Ltd.
Address: The West of 4 Floor, Building No. 4, Industry Incubator of Baoqing
Industrial Park, Shuangqing District, Shaoyang City, Hunan Province, 422000,
China
Tel: 86-739-5188959
Fax: 86-739-5188939
Zip Code: 422000
Web: www.ventmed.net

Authorized Representative:
Company: Llins Service & Consulting GmbH

Address: Obere Seegasse 34/2, 69124, Heidelberg, Germany

Tel: +49 175 4870 819

File No.: VM-QD-733-01 Version: A/ 0