Instruction Manual

Portable Suction Machine

AC/DC
SU100DC

Sunset Healthcare Solutions

180 N Michigan Ave Ste 2000
Chicago, IL 60601
United States

This device complies with EU EMC standard EN60601-1-2

SU100DC-IFU V 3.00
2019-03-28
Table of Contents

Intended Use ................................................................................................ 2

Included ........................................................................................................ 2
Important Safeguards ................................................................................. 3
Device Specifications .................................................................................. 4
Warranty ...................................................................................................... 4
Operating Instructions ................................................................................ 5
Cleaning, Sterilization, and Disposal .......................................................... 6
Replaceable Parts and Accessories ............................................................ 7
Legend ......................................................................................................... 7
Electromagnetic Compatibility (EMC) / Recommended Safe Distances ... 8-9

Intended Use
This Electric Suction Unit is intended for the removal of fluids from the airway or respiratory system. This appliance
may also be used in the removal of infectious materials from patient wounds.

Utilizing a motor to drive an air pump to generate negative pressure (vacuum), this device will aspirate mucous
secretions from the patient’s body, in the management and treatment of respiratory diseases. Aspirated secretions
are collected in the canister for proper disposal.

Caution: Federal law restricts this device to sale by or on the order of a physician

Included

Machine
AC Adapter and Power Cord
Carrying Bag
800cc Suction Canister
1.5in Suction Tube Connector
10in Suction Tube Connector
6ft Suction Tubing
Hydrophobic Inline Filter
Air Filters (6)

2
Important Safeguards
Note: Read all instructions carefully before use.

Warning: Modification of this equipment voids the Warranty.

No modification of this equipment is allowed.
To avoid strangulation, keep children away from the power cord.

Caution: Failure to read and observe all precautions could result in personal injury or
equipment damage.

Product Caution
• To avoid electrical shock, keep the unit away from water; do not immerse the power cord or the unit in any
liquid; do not use while bathing; do not reach for a unit that has fallen into water - immediately unplug the unit.
• Never operate the unit if it has any damaged parts (including power cord), and/or if it has been dropped or
submersed in water.
• The unit should not be used where flammable gas, oxygen or aerosol spray products are being used.
• Disconnect the unit from the electrical outlet before cleaning, filling and after each use.
• When in operation, ensure the power cable is accessible, but out of the way from accidental disconnection.
• Place the device near an outlet within reach of the patient on a flat and stable surface. Make sure that the
ventilation slit on the side of the device is not blocked.

Operating Caution
• Connect this product to an appropriate voltage outlet for your model.
• Do not run this product unattended.
• If any abnormality occurs, discontinue use immediately until the unit has been examined and repaired.

Storage Caution
• Do not store the unit in direct sunlight, extreme temperature or humidity.
• Keep the unit out of reach of children.
• Keep the unit unplugged while storing.

Cleaning Caution
• Clean after each use as instructed in this guidebook.
• Do not immerse the unit in water. It may damage the unit.
• Disconnect the unit from the electrical outlet before cleaning.

3
Device Specifications

Rated Power Input AC 100-240V, 50-60Hz, 1.1A / DC 12 V

Power 48VA Max
Max Negative Pressure 530mmHg
Negative Pressure Range 150-530mmHg
Max Suction Speed 25 Lpm
Canister Capacities 800cc, 1,000cc, 1,200cc
Dimensions 13 3/8 x 6 1/4 x 8 3/4 in (340 x 160 x 220 mm)
Weight 5.29 lbs (2.4 kgs)
Operating Environment 50ºF to 104ºF (10ºC to 40ºC), 30% to 75% Relative Humidity
Storage Environment -4ºF to 140ºF (-20ºC to 60ºC), 10% to 95% Relative Humidity
Noise < 60 dBA at 1 meter

TWO YEAR LIMITED WARRANTY

This unit is warranted to be free from defective workmanship and materials for a period of two years from the
date of purchase. Any defective part will be replaced or repaired at manufacturer’s prudence. If proper care and
maintenence of this unit is not followed as detailed within the operating manual, the warranty is subject to be
terminated. If warranty repair is needed, please contact the place of purchase.

Power Indicators

Power Status
GREEN Device is in use
RED Battery low

Battery Status
GREEN The battery is fully charged
GREEN Flashing The battery is charging

4
Operating Instructions
Installing the filter
• Open the accessories bags and take out the two
connector tubes and the filter.
• Connect one end of the short tube to the air
input port and the other end to the filter.
• Connect the filter to the suction canister with the long
connector tube.
With 800cc canister
• Inspect suction tubing and canister for leaks or cracks
before each use.

Turn on the device With 1,000cc canister

• To use the machine without battery power, plug in

the power cord. To use with battery power,
unplug the machine. With 1,200cc canister
• Turn on the power switch.
• Connect the suction tube to the device, open the
suction valve, and make sure airway is unobstructed.
• Adjust the negative pressure using the knob; choose
the appropriate negative pressure for the appropriate
physician-recommended treatment of the patient.

Turn off the device

• After the treatment is over, turn off the power switch.
• The working cycle of the device is 30 minutes on and
30 minutes off.

Battery charging
• If plugged in, the battery will start charging when
device is turned off.
• Battery charge time is less than eight hours.
• Battery may be used for up to one hour when fully
charged.

Note: If the device is connected with the power cord,

the device will not draw power from the battery.

Note: If battery is not regularly used, it is

essential to charge it every 3 months to
maintain battery functionality.

5
Cleaning, Sterilization, and Disposal

! Disconnect from power source prior to cleaning

• It is recommended that the tubing and canister be thoroughly cleaned with hot water after each use and
be cleaned with a mild detergent after the last treatment of the day. If your physician or respiratory therapist
specifies a different cleaning procedure, follow their instructions.
• The filter cannot be cleaned.
• If the filter gets wet, or becomes contaminated or clogged, it must be replaced.

Rinsing (after each treatment)

• Disconnect the tubes, canister and the filter cover. Rinse the tubes and canister with water.
• Dry them with a clean, soft towel or let air dry.
• Reassemble the product when completely dry and put in a clean, sealed container.

Disinfection
Please abide by the following steps to disinfect your suction device unless otherwise specified by a physician. It is
suggested that the unit is disinfected after each treatment.
• Using one part white vinegar with three parts distilled water, make a bath to submerge the tubes and canister.
• Disconnect the tubes and canister from the machine and filter. Wash the tubes and canister in warm water and
mild detergent. Then wash them in hot tap water.
• Submerge the tubes and canister in the vinegar and water solution bath for 30 minutes.
• Dry tubes and canister with clean soft towel or let air dry.
• Reassemble the product when completely dry and put in a clean, sealed container.

Changing the air filter

Open the small circular hatch on the bottom of the unit counter-clockwise. Replace the BF018 foam air filter if it
appears to be dirty, or after 3 months of use.

! Danger of infection

The device and accessories may come into contact with infectious material and be contaminated during
their lifetime. For this reason, the device and its accessories should be decontaminated before disposal or
transportation.
Dispose of the device properly at the end of its service life. According to the European Directives 2002/96 / EC
(WEEE) and 2002/95 / EC (RoHS) the device may not be disposed of with unsorted domestic waste. Carefully
separate materials. Consider local and country-specfic laws and regulations that apply to the disposal of the
device. The proper disposal prevents environmental damage and human harm.
Commercial bacterial germicides specifically intended for cleaning medical devices within the institutional
envrionment may be used to clean this equipment, in compliance with the germicide manufacturer’s
recommended instructions.
6
Replaceable Parts and Accessories
Always use Sunset Healthcare Solutions parts:

Short Connector Tube RES024S

Long Connector Tube RES024L10
Suction Tubing RES025 or FDA or CE approved 1/4in or 6mm ID / 9mm OD suction tubing
Hydrophobic Inline Filter BF1312
Canister 800cc RES023S
AC Adapter without Cord SU100DC-Adapt
Power Cord without Adapter SU100DC-Cord
Sunset Suction Kit (Includes 800cc Canister, Short Tube, Long Tube, Hydrophobic Inline Filter, Suction Tube) RES026S-SS
Sunset Component Kit (Includes Short Tube, Long Tube, Hydrophobic Inline Filter) RES024S-KIT
Air Filter BF018

Legend
Consider instructions for use Not for reuse

Manufactu rer REF Order number

Date of manufacture LOT Batch number

Use by SN Serial number

LATEX
Latex free Attention

Contains phthalate Sto re away from sunlight

70°C

Type BF -25°C
Temperature Limit

93%

Protection class II Relative humidity, limit

15%

Protec tion agains t contact with fin-

Do not use when packaging is damaged IP 22 gers and medium-sized solid bodies,
protec tion against dripping water.

STERILE EO Sterilized with ethylene oxide Direct Voltage

Status display power supply Status display state of charge

Vacuum connection Patient tube connection

On (Power)

OFF (Power) QTY Quantity

Adjusting direction to increase (+)

and decrease (-) the vacuum L Length

Asp. MAX Maximum Vacuum CH Charrière

High The device and its components

may not be disposed of with normal
Vacuum / High Vacuum / High Flow commercial or household waste
High Fl ow (batteries in particular).

7
Electromagnetic Compatibility (EMC) / Recommended Safe Distances
Medical equipment needs special precautions regarding electromagnetic compatibility (EMC). The device needs to
be installed and put into service according to the EMC information provided in this chapter.
Portable and Mobile RF Communications Equipment can effect Medical Electrical Equipment. Use this table as
a guide to help prevent electromagentic interference by maintaining a minimum distance between mobile RF
Communications Equipment (transmitters) and the suction unit.

Guideline and declaration by the manufacturer -

electromagnetic emissions - for all devices and systems!
The device is constructed in such a way that it can also be used in a specific electromagnetic
field. The user must ensure that this product is used under the following conditions.
Emissionstest Compliance Electromagnetic Environment - Guidelines

RF-Emission Group 1 The device uses RF energy for its internal functions. For this
CISPR 11 reason, the probability that the electrical devices in the
vicinity are disrupted by the RF emissions is very low.

RF-Emission Class B Radiated

CISPR 11 and Conducted
Emissions

This device is suitable for use in all establishments including

Harmonic emissions Class A
domestic, and those directly connected to the public low-
IEC 61000-3-2
voltage power supply network that supplies buildings used
for domestic purposes.

Voltage fluctuations/ Complies

flicker emissions
IEC 61000-3-3

Immunity Test IEC 60601 Compliance Electromagnetic

Test Level Level Environment - Guidelines

Discharge of static +/- 6kV Contact +/- 6kV Contact The substrate should be made of
electricity (ESD) +/- 8kV Air +/- 8kV Air wood, concrete or ceramic tiles. If
IEC 61000-4-2 the floor is covered with synthetic
material, the relative humidity must
be at least 30%.

Electrical Fast Transient/ ±2kV on AC Mains ±2kV on AC Mains

burst IEC 61000-4-4
Mains power quality should be that
of a typical commercial or hospital
Surge ±1kV Differential ±1kV Differential environment.
IEC 61000-4-5 ±2kV Common ±2kV Common

Voltage dips, short >95% Dip for >95% Dip for Mains power quality should be that
interruptions and 0.5 Cycle 0.5 Cycle of a typical commercial or hospital
voltage variations on 60% Dip for 60% Dip for environment. If the user of this
power supply input 5 Cycles 5 Cycles device requires continued operation
lines IEC 61000-4-11 30% Dip for 30% Dip for during power mains interruptions, it
25 Cycles 25 Cycles is recommended that the device be
>95% Dip for >95% Dip for powered from an uninterruptible
5 Seconds 5 Seconds power supply or battery.

8
Immunity Test IEC 60601 Compliance Electromagnetic
Test Level Level Environment - Guidelines

Magnetic fields with 3A/m 3A/m Magnetic fields with energy fre-
energy frequencies quencies should be located
(50/60 Hz) at a level typical for normal com-
IEC 61000-4-8 mercial or hospital
environments.

Conducted RF 3 Vrms from V1 = 3 Vrms Portable and mobile RF communi-

IEC 61000-4-6 150 kHz to 80 MHz cations equipment should be sepa-
rated from the device by no less
than the recommended separation
distances calculated/listed
below: D=(3.5/V1)√P

Radiated RF 3 V/m E1 = 3V/m D=(3.5/E1) √P 80 to 800 MHz

IEC 61000-4-3 80 MHz to 2.5 GHz D=(7/E1)√P 800 MHz to 2.5 GHz
Where P is the maximum starting
capacity of the transmitter in watts
(W) and d is the recommended
distance in metres (m) pursuant to
the transmitter manufacturer infor-
mation. The field strength of the
fixed RF transmitter, which
is determined by an electroma-
gnetic site appraisal a, must fall
under the compliance level in each
frequency rangeb. Disruptions may
occur near devices, which are
characterized by the following:

For transmitters rated at a maximum output power not listed above, the recommended separa-
tion distance D in meters (m) can be estimated using the equation applicable to the frequency
of the transmitter, where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.

Recommended distances between portable and mobile RF communication

equipment and the suction pump. This device and system are not Life-Supporting.

The suction pump is intended for use in the electromagnetic environment in which radiated
disturbances are controlled. The customer or user of this device can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF Communications Equipment and the device as recommended below, according to the maxi -
mum output power of the communications equipment.

Maximum power Distance pursuant to transmitter frequency (m)

output of the 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
transmitter (W) D=(1.1667) √P D=(1.1667) √P D=(2.3333) √P
0.01 0.11667 0.11667 0.23333

0.1 0.36894 0.36894 0.73785

1 1.1667 1.1667 2.3333

10 3.6894 3.6894 7.3785

100 11.667 11.667 23.333

For transmitters rated at a maximum output power not listed above, the recommended separation
distance D in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects, and people.