Operating Instructions - E341Battery - GB - 2021-11 - Vers13 - Webopt
Operating Instructions - E341Battery - GB - 2021-11 - Vers13 - Webopt
GA1GB.320102.0
2021-11 Index: 13
Table of contents
1.0 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.1 Information on operating instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.2 Explanation of pictures and symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.3 Intended use and side effects. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.4 Function. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.5 Intended operators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.6 Scope of delivery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.7 Transport and storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.0 Hints for your safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.1 General safety information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.2 Danger for users, patients and third parties. . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.3 Damage to the device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
3.0 Setting up and starting up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3.1 Device overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3.1.1 Front and rear view. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3.1.2 Control panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3.2 Preparing the device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3.3 Charging the battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.4 Connection and removal of canister system and hoses. . . . . . . . . . . . . . . . . . 18
3.4.1 DDS canister system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
3.4.2 Serres® canister system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
3.4.3 Medi-Vac® canister system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
3.5 Support for canister system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
3.5.1 DDS canister system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
3.5.2 Serres® canister system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
3.5.3 Medi-Vac® canister system / Universal bracket. . . . . . . . . . . . . . . . . . . . . . . 28
3.6 Hose rewind. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
3.7 Device base . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
4.0 Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
4.1 Switching on the device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
4.2 Switching off the device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
4.3 Vacuum adjustment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
4.4 Suction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
5.0 Cleaning and disinfection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
5.1 Preparing for cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
5.2 Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
5.3 After cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
5.4 Recommended disinfectants. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
5.4.1 Instrument disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
5.4.2 Surface disinfection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
5.5 Hygienic plan. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
5.6 Oversuction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
2
6.0 Maintenance and service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
6.1 Periodic tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
6.2 Function check. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
6.2.1 Manual function check. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
6.2.2 Automatic function check. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
6.3 Sending in the device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
6.4 Handling of batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
6.5 Battery exchange. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
6.6 Exchanging the release button. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
7.0 Eliminating errors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
8.0 Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
8.1 Wall and device support. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
8.2 Retrofit kit canister system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
9.0 Spare parts and consumables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
10.0 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
11.0 Technical data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
12.0 Notes on EMC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
ATMOS
MedizinTechnik GmbH & Co. KG
Ludwig-Kegel-Straße 16
79853 Lenzkirch
Germany
Tel. + 49 7653 689-0
+ 49 7653 689-222 (Service Centre)
Fax: + 49 7653 689-190
+ 49 7653 689-292 (Service Centre)
[email protected]
www.atmosmed.de
3
1.0 Introduction
1.1 Information on operating instructions
Care, periodic tests, regular cleaning and proper application are indis-
pensable. They guarantee the operational safety and usability of the
ATMOS E 341 Battery.
Maintenance, repairs and periodic tests may only be carried out
by persons who have the appropriate technical knowledge and are
familiar with the product. To carry out these measures, the person
must have the necessary test devices and original spare parts.
Prior to first start-up, please peruse chapter “2.0 Hints for your safety”
4 Introduction
1.2 Explanation of pictures and symbols
DANGER
Warning of a danger which causes immediate death or serious injury. Observe the
necessary measures.
WARNING
Beware of a danger which can cause death or serious injury. Observe the necessary
measures.
CAUTION
Beware of a danger which can easily hurt you. Observe the necessary measures.
NOTICE
Indication of a danger where the product or other items can be damaged. Observe
the necessary measures.
Introduction 5
On the recharging accessories
This device complies with the
Consult operating instruc-
relevant requirements of EU regula-
tions
tions
On the battery
This device complies with the
Consult operating instruc-
relevant requirements of EU regula-
tions
tions
Intended use
Name: ATMOS E 341 Battery
Main functions: Temporary and spontaneous suction of secretion, blood and body
fluids and also liquid, viscous and solid pieces of food in the medical field.
To evacuate vacuum mattresses and inflatable splints.
Medical indications / application: Suction of the upper and lower respiratory tract.
Specification of the main function: Drainage and temporary collection of body
fluids. By means of an electrical suction pump, a negative pressure will be created. The
integrated secretion canister allows temporary collection of the derived body fluids.
Application organ: Upper respiratory tract (nose, nasal cavity, throat), lower respiratory
tract (larynx, trachea, bronchial system)
6 Introduction
Application time: Temporary use on the patient (< 60 min)
Application site: The application site is the hospital, the practice, the accident &
emergency department, the nursing and home care field, as well as for outdoor appli-
cation and during transport. The device may only be applied by medically trained and
instructed staff.
Contraindications: Not suitable for
• The continuous operation by drainages in the low vacuum range (e.g. thorax
drainages or wound drainages).
• Permanent endoscopic use.
• Suction in medical rooms where a potential equalisation is necessary (e.g. heart
surgery).
• Use outside the medical field.
• Suction of flammable, corrosive or explosive substances.
• Suction in explosion-hazardous areas.
The product is: active
Sterility: Non-sterile product
Single-use product / reprocessing: The device and part of the accessories are
reusable. For information on reprocessing, cleaning and disinfection please see the
operating instructions.
Introduction 7
1.4 Function
The ATMOS E 341 Battery is a mobile, portable, mains-operated medical device for the
temporary application on adults, children and babies. The device is operated with an
electronically controlled, maintenance-free diaphragm pump.
The pump can be optionally operated by rechargeable battery or via an external DC
voltage source (12 V).
During operation, the pump generates a vacuum within the hose system and secretion
canister, thus suctioning off secretion, blood and body fluids as well as liquid, viscous
and solid pieces of food. The fluid is gathered in the secretion canister.
The predefined vacuum values enable a quick and precise adjustment of the vacuum in
different situations. It can be selected between four different vacuum values (−0.1 bar;
−0.2 bar; −0.5 bar and −0.8 bar). The control panel is illuminated so that you can read
the operating status even in the dark.
An overtemperature stop prevents overheating of the batteries.
DDS secretion canister:
The DDS secretion canister is affixed laterally to the device and is plugged via Direct
Docking onto the suction connection of the support for the DDS canister system.
Therefore, there is no intermediate hose. Now the user can/must only connect the
suction hose. A hydrophobic DDS bacterial and viral filter located in the canister lid
prevents bacteria, viruses and liquids from entering the device.
A mechanical oversuction stop (float ball) is integrated in the canister lid. This prevents
an accidental absorption of secretion into the pump head. The float ball rises to the top
of the secretion until it blocks the outlet.
Disposable secretion canister:
The disposable secretion canister is comprised of an external canister, disposable
suction bag, vacuum hose and the disposable suction hose.
The disposable secretion canister is affixed laterally to the device. The vacuum hose of
the canister is connected to the suction connection of the device. The secretion is trans-
ported to the disposable suction bag via the suction hose. The disposable suction bag
is a single-use product. As soon as the disposable suction bag is full, it is removed from
the external canister and disposed of. The disposable suction bag and the disposable
suction hose must not be reused.
A bacterial filter is integrated in the disposable suction bag. This prevents secretion,
liquid and bacteria from seeping into the device.
8 Introduction
1.6 Scope of delivery
1. Please compare the contents on completeness immediately upon receipt (see
delivery note).
Basic device
Introduction 9
Universal bracket (not mounted)
10 Introduction
2.0 Hints for your safety
The safety of the ATMOS E 341 Battery complies with all the recognised rules of
technology and the Directives of the Medical Devices Act.
Read and follow the safety instructions carefully before using the product.
5
6 Connection charging acces-
sories
7 Guide for the wall and device
support
8 9 10 11 12 8 Filter holder
9 Sealing ring
10 Hydrophobic DDS bacterial
13 and viral filter
14 11 Inner canister lid
15
12 External canister lid
16 13 Canister lid lug
17
14 Float ball
15 Secretion canister with scale
16 Connection suction hose
17 Support for DDS canister
system
8
8 Angle (connection disposable
suction hose)
9 Serres® suction bag
10 Serres® external canister
9 11 Support for Serres® canister
system
13
12 Grey angle on the Serres®
12
external canister (connection
10 vacuum hose)
11 13 Vacuum hose with angled
connection
5 4
Green
and red
Flashes LED flash
11. Place the canister system upright from above into the support: Chapter “3.4
Connection and removal of canister system and hoses” on page 18
12. Wrap the suction hose onto the hose rewind.
13. If you wish to use the device for vacuum mattresses: Check whether a suitable
adapter is available for the vacuum mattresses.
2. Connect the power cable to the power supply and recharging unit.
3. Plug the power plug of the power supply and recharging unit into the socket.
» The LEDs of the battery status display flash successively.
» One LED is continuously illuminated. This indicates the current battery status.
» The battery is fully recharged when the top red LED is continuously illuminated.
7. Remove the filter holder with DDS bacterial and viral filter from the canister lid.
8. If required: Remove the DDS bacterial and viral filter 7 and the sealing ring 6 from
the filter holder 5 .
5
11. If required: Remove the float ball 3 from the float ball compartment 2 of the inner
canister lid 1 .
1 2
3
1. Press the external canister lid 4 on the inner canister lid 1 until it clicks into place.
2. Open the float ball compartment 2 gently and insert the float ball 3 .
3. Gently press the float ball compartment together.
4. Check whether the float ball moves easily and does not fall out of the float ball
compartment.
5. Place the secretion canister on a firm surface.
6. Press the canister lid onto the secretion canister. The canister lid cannot be placed
in a wrong position.
7. Press the canister lid tightly with both hands as far as it will go onto the secretion
canister.
8. Place the sealing ring 6 onto the filter holder 5 .
6
5 6
9. Put a new DDS bacterial and viral filter 7 onto the filter holder 5 .
5
10. Insert the filter holder into the canister lid and turn it clockwise until it clicks into
place.
click
13. Check that the clip 1 of the canister lid is correctly attached to the support of the
canister system.
» The vacuum connection from the pump to the canister system is established.
14. Check whether the hose has a kink. If applicable, remove the kink.
15. Insert the suction hose into the hose guide of the device base.
Removal
1. Remove the disposable suction hose from the hose guide.
2. Remove the disposable suction hose and the angle 2 from the Serres® suction bag.
3. Close the connection “patient” on the Serres® suction bag with the green cap 3 .
4. Remove the vacuum hose from the Serres external canister (grey angle
® 1 ).
5. Remove the Serres canister system from the support.
®
Connection
1. Connect the vacuum hose to the device.
2. Place the Serres® external canister upright into the support. The scale must be
visible.
3. Insert the Serres® suction bag into the Serres® external canister.
5. Check whether the foil of the Serres® suction bag is fully inserted into the Serres®
external canister and the lid tightly fits to the Serres® external canister.
6. Connect the disposable suction hose with the angle 2 to the Serres® suction bag.
7. Close the secondary air opening of the fingertip and close the front opening with
your thumb.
8. Switch on the device so that the pump builds up vacuum.
» The Serres® suction bag unfolds.
9. Insert the suction hose into the hose guide.
Removal
1. Remove the disposable suction hose from the hose guide.
2. Remove the disposable suction hose and the angle 2 from the Medi-Vac® suction
bag.
3
4
3. Close the connection “patient” on the Medi-Vac® suction bag with the blue cap 3 .
4. Remove the red hose 1 from the Medi-Vac suction bag.
®
5. Close the connection “vacuum” on the Medi-Vac® suction bag with the blue cap 4 .
6. Remove the vacuum hose from the red connection 5 of the Medi-Vac external
®
canister.
7. Remove the Medi-Vac® canister system from the support.
8. If required: Remove the vacuum hose from the device.
Connection
1. Connect the vacuum hose to the device.
2. Insert the Medi-Vac® suction bag into the Medi-Vac® external canister.
3. Connect the red hose 1 to the Medi-Vac® suction bag.
4. Place the Medi-Vac® external canister upright into the support.
6. Check whether the lid tightly fits to the Medi-Vac® external canister.
7. Connect the disposable suction hose 2 to the Medi-Vac® suction bag.
8. Close the secondary air opening of the fingertip and close the front opening with
your thumb.
9. Switch on the device so that the pump builds up vacuum.
» The Medi-Vac® suction bag unfolds.
10. Insert the suction hose into the hose guide.
Removal
1. Remove the canister release.
2. Push the support for the DDS canister system backwards up to the middle and take
it out of the guides.
Mounting
1. Attach the support for the DDS canister system in the middle on the right side of
the device. The bars on the support must be fitted to the two guides on the device.
2. Slide the support for the DDS canister system forward until it is flush with the
device. The inlet to the pump must be visible.
& The canister release is at the same time the connection angle through which the
canister system is connected to the pump.
Removal
1. Remove the connection angle.
2. Push the support for the Serres® canister system backwards up to the middle and
take it out of the guides.
Mounting
1. Attach the support for the Serres® canister system in the middle on the right side of
the device. The bars on the support must be fitted to the two guides on the device.
2. Slide the support for the Serres® canister system forward until it is flush with the
device. The inlet to the pump must be visible.
Removal
1. Remove the connection angle.
2. Push the support of the canister system backwards up to the middle and take it out
of the guides.
Mounting
1. Attach the support of the canister system in the middle on the right side of the
device. The bars on the support must be fitted to the two guides on the device.
2. Slide the support of the canister system forward until it is flush with the device. The
inlet to the pump must be visible.
& The universal bracket is suitable for secretion canisters with a diameter of
11.5 – 12.5 cm.
& Do not operate the device without a bacterial filter.
Removal
Prerequisite: The hose is unwound.
1. Pull the wings outwards so that the hose rewind can be released.
2. Pull the hose rewind from the device.
Mounting
Prerequisite: Device base and battery compartment cover are attached.
1. Turn the hose rewind so that the opening points upwards.
2. Attach the hose rewind with force to the support on the left side of the device until
it clicks into place.
click
Removal
Prerequisite:
The following parts are removed:
• Canister system
• Support for canister system
• Hose rewind
• Battery compartment cover
1. Put the device carefully on the front.
2. Remove the device base in the following order A - B - C - D:
A
D
B
C
Mounting
NOTICE
Incorrectly mounted device base.
Device moves during the operation.
• Attach the device base with particular care, according to the operating instructions.
Prerequisite:
The following parts are removed:
• Canister system
• Support for canister system
• Hose rewind
• Battery compartment cover
1. Put the device carefully on the front.
2. Take care that the indentations at the device base are fitted to the protruding edges
on the device.
3. Attach the device base in the following order D - C - B – A. The arrows show the
points at which the device and the device base have to engage with each other.
A
D
B
C
32 Operation
4.4 Suction
WARNING
Device failure if the period of continuous operation is too long.
Patient can suffocate.
• Make sure not to use the device in continuous operation for more than 60 minutes.
Otherwise, the pump shuts off automatically. In this case, let the device cool down
for about 2 hours.
• Check the status of the battery regularly while you operate the device.
Risk of infection.
Deadly diseases can be transmitted.
• Always wear disposable gloves during suction.
CAUTION
Risk of injury due to inappropriate material or untrained users.
Injuries in the oral cavity and pharynx of the patient.
• Suction may only be carried out by persons who were medically trained and were
trained in medical suction.
• Use a suction catheter for tracheal or nasopharyngeal suction.
• If you suction viscous food ingredients in the oral cavity, use the suction hose
without the suction catheter.
Operation 33
Suction
CAUTION
Adherence due to careless suction.
Injuries in the oral cavity and pharynx of the patient.
• Briefly open the secondary air opening if the suction catheter adheres to the
tissue.
• Suction particularly carefully in the tracheal area.
If secretion has penetrated into the device, please observe chapter “5.6 Oversuction” on
page 41.
After use
1. Switch off the device by pressing the on/off button for at least 1 second.
2. Clean the device after each use: Chapter “5.0 Cleaning and disinfection” on page
35.
3. Perform a function check after each cleaning: Chapter “6.2 Function check” on page
42.
34 Operation
5.0 Cleaning and disinfection
We recommend that you document any maintenance work and also any exchange of
parts.
WARNING
Risk of infection due to secretion on the device, accessories and consumables.
Deadly diseases can be transmitted.
• Always wear disposable gloves during any cleaning.
• Clean the device after every use:
• Clean and disinfect the device according to the operating instructions.
• The device must be reprocessed professionally if secretion has penetrated into the
device. Please observe chapter “5.6 Oversuction” on page 41.
5.2 Cleaning
Please observe the operating instructions of the disinfectant manufacturers. Pay
particular attention to the information regarding the concentration of the disinfectants
and the material compatibility.
Some disinfectants may stain the parts of the canister lid and silicone hoses. Parts can
also stain due to autoclaving. However, this has no influence on the properties of the
materials.
Please only use disinfectants which are recommended by ATMOS (chapter “5.4 Recom-
mended disinfectants” on page 38). The use of other disinfectants may damage the
device or the canister system.
Vacuum hose
After every suction process:
1. Rinse the vacuum hose with clear water for at least 10 seconds.
It must be exchanged after each patient or at least once a day:
2. Disinfect the vacuum hose with an instrument disinfectant recommended by
ATMOS.
1. Clean the entire surface of the device and the hose rewind with a damp cloth.
2. Disinfect the entire surface of the device and the hose rewind with a surface disin-
fectant.
1. Clean the power supply and recharging unit with a damp cloth. You can use a mild
detergent.
2. Disinfect the power supply and recharging unit with a surface disinfectant. Recom-
mended: Terralin® Protect.
Coated surfaces
Disinfectant Ingredients (in 100 g) Manufacturer
Green & Clean SK Di alkyl dimethyl ammonium chloride <1g Metasys, Rum
Alkyl dimethyl ethyl benzyl ammonium chloride <1g (Austria)
Alkyl dimethyl benzyl ammonium chloride <1g
Dismozon® pur magnesium monoperoxyphthalate hexahydrate 80 g Bode Chemie,
(Granulate) Hamburg
End of product 12/2014
Dismozon® plus magnesium monoperoxyphthalate hexahydrate 95.8 g Bode Chemie,
(Granulate) Hamburg
Kohrsolin® FF glutaral 5 g Bode Chemie,
(Application concentrate) benzyl-C12-C18-alkyldimethyl-ammonium 3 g Hamburg
chlorides 3g
didecyldimethylammonium chloride
Kohrsolin® extra (ethylenedioxy)dimethanol 14.1 g Bode Chemie,
(Application concentrate) glutaral 5 g Hamburg
didecyldimethylammonium chloride 8g
Perform® Potassium-bis(peroxymonosulfate)-bis(sulfate) 45 g Schülke & Mayr,
Norderstedt
Terralin® Protect benzyl-C12-16 alkyldimethyl-, chloride 22 g Schülke & Mayr,
(Application concentrate) 2-phenoxyethanol 17 g Norderstedt
aminoalkylglycine 0.9 g
non-ionic surfactants, perfumes
Other surfaces
Disinfectant Ingredients (in 100 g) (in 100 g) Manufacturer
Dismozon® pur magnesium monoperoxyphthalate hexahydrate 80 g Bode Chemie,
(Granulate) Hamburg
End of product 12/2014
Dismozon® plus magnesium monoperoxyphthalate hexahydrate 95.8 g Bode Chemie,
(Granulate) Hamburg
Kohrsolin® FF glutaral 5 g Bode Chemie,
(Application concentrate) benzyl-C12-18-alkyldimethyl-ammonium chlorides 3 g Hamburg
didecyldimethylammonium chloride 3g
Kohrsolin® extra (ethylenedioxy)dimethanol 14.1 g Bode Chemie,
(Application concentrate) glutaral 5 g Hamburg
didecyldimethylammonium chloride 8g
C D S
Disinfection
Sterilization
Qualified and trained staff who
/ after each
Parts to be reprocessed
are familiar with reprocessing
Cleaning
suction
Daily*
Surfaces
Housing X X Wipe cleaning and disinfection X X
Recommended disinfectants Important information The above stated hygiene requirements are based on
the regulations according to the Medical Devices Act, the
Surface disinfection for coated surfaces: Manual disinfection of instruments: Wipe cleaning and disinfection: Medical Devices Operator Ordinance, §18 IfSG and the
• Green & Clean SK (ATMOS) • Mucocit®-T (Merz Dental) All surfaces have to be wiped with recommendations of the Robert Koch Institute.
• Dismozon® pur (Bode Chemie) • Gigasept® FF neu (Schülke & Mayr) a clean (disposable) wipe which is Definition of the required reprocessing steps result
from the recommendations of the Robert Koch Institute:
• Dismozon® plus (Bode Chemie) • Sekusept® PLUS (Ecolab) damped with disinfectant solution. „Requirements for the reprocessing of medical products“,
• Kohrsolin® FF (Bode Chemie) The entire surface has to be wiped from Robert Koch Institute. The medical products were
• Kohrsolin® extra (Bode Chemie) thoroughly and may not be dried categorised in the risk groups uncritical, semi-critical and
• Perform® (Schülke & Mayr) For concentrations, contact time, tem- afterwards. critical. The reprocessing measures mentioned in this
cleaning and disinfection plan are a recommendation
• Terralin® Protect (Schülke & Mayr) perature, material compatibility, please of ATMOS MedizinTechnik. Any additional reprocessing
see the relevant information from the 1)
Preferred: mechanical cleaning and measures are at the operator‘s discretion.
Other surfaces: manufacturer. All the recommended disinfectants which are stated
• Dismozon® pur (Bode Chemie) disinfection in the washer disinfector herein are listed disinfectants (VAH/RKI) and have
• Dismozon® plus (Bode Chemie) with a device according to the ISO been tested on their suitability of use on the ATMOS C
• Kohrsolin® FF (Bode Chemie) 15883-1 (Program: Rinsing 1 min with / E 341 Battery. ATMOS MedizinTechnik cannot be hold
liable for any damage caused by wrong concentration
• Kohrsolin® extra (Bode Chemie) Wrong concentration of cold water, cleaning 5 min at 55°C,
of the disinfectants or by the application of any other
• Mikrobac® forte (Bode Chemie) disinfectants may lead to neutralisation 1 min with 1/3 cold and disinfectants.
• Perform® (Schülke & Mayr) material damage! 2/3 warm water, rinsing 1 min with Patients with suspicion of a clinical disease or who
purified water, thermal disinfection 5 developed a transmissible spongiform encephalopathy
• Terralin® Protect (Schülke & Mayr) (CJK, vCJK, etc.) have to be treated at facilities which are
• SaniCloth® Active (Ecolab) min at 93°C with purified water) able to provide for the necessary preventive measures
• Incidin® Active (Ecolab)
2)
If required hot-steam sterilization at against infection. The reprocessing of the reusable
134°C, 3 x fractionated pre-vacuum instruments and material may only be performed
• Mikrozid® Sensitive Wipes (Schülke at facilities which have an externally certified QM
& Mayr) method, sterilization time 5 min with a Management acc. to DIN EN ISO 13485.
• Gigasept® pearls (Schülke & Mayr) device according to EN285 The Medical Devices Act, IfSG, the RKI directives, BGR 250
* Homecare, unless there is no change and TRBA 250 always have to be considered.
Termination
1. Press the button for the battery status.
» The device switches off.
Result
Remaining operating hours
1. 2. 3. 4. Short signal tone:
< 50 h
1. Please contact your
service.
> 750 h > 500 h > 250 h < 250 h
Remaining battery capacity
1. 2. 3. 4. Short signal tone:
< 10%
1. Exchange the battery.
6. Lift the battery compartment cover slightly and remove it from the upper guide.
The detent 2 could break off due to the incorrect removal of the cable.
7. Remove the cable from the device by pressing the detent 2 of the plug against the
plug and simultaneously pull the plug.
2. Replace with a new release button. Pay attention that the two springs are
positioned in the guide of the release button.
Eliminating errors 47
Error indication Possible cause Remedy
All the LEDs on the Battery is not inserted. 1. Insert the battery.
display of battery status Battery is not 1. Check the plug connections in
flash permanently. connected properly. the battery compartment.
Defective battery. 1. Exchange the battery.
Defective electronics. 1. Send in the device for repair.
Battery compartment Battery is not fitted 1. Fit the battery correctly.
cover cannot be closed. correctly.
Battery compartment 1. Mount the battery
cover is installed incor- compartment cover correctly
rectly. according to operating instruc-
tions.
48 Eliminating errors
Vacuum and suction capacity
Error indication Possible cause Remedy
Vacuum is not built Battery is discharged or 1. Recharge or exchange the battery.
up or cannot be defective.
reached. Leakages in the hoses 1. Check canister lid and hoses for
or the canister system. tight fit.
2. DDS canister system: Firmly insert
the hydrophobic DDS bacterial
and viral filter and check the
sealing ring and filter holder.
Fingertip is not closed. 1. Close both openings of the
fingertip.
Liquid has penetrated 1. Send in the device for repair.
the device.
Pump is defective or 1. Send in the device for repair.
the device has a leak.
Low ambient pressure Not possible.
(e.g. high altitude).
Low suction capacity Hydrophobic DDS 1. Replace the hydrophobic DDS
although the vacuum bacterial and viral filter bacterial and viral filter.
has been reached. is blocked.
Hose is kinked. 1. Check the hoses.
DDS canister system: 1. Check and, if needed, clean
Float ball closes the the float ball and the float ball
suction area. compartment.
Eliminating errors 49
8.0 Accessories
Accessories REF
Serres® external canister 1 l 312.0465.0
Medi-Vac® external canister 1 l 312.0473.0
DDS canister system 1 l, complete 318.1000.0
Wall and device support for ATMOS Emergency Suction Devices 318.1250.0
Retrofit kit DDS canister system 318.1350.0
Retrofit kit Serres canister system
®
318.1450.0
Retrofit kit Medi-Vac® canister system 318.1650.0
1 4
Wall mounting
& Only affix the power supply and recharging unit after you have marked the holes to
be drilled.
& Screws are not included in delivery.
1. Only use screws (max. 4 mm) which are suitable for the material of the wall.
2. Position the wall and device support at an easily accessible place.
3. Check whether the wall is smooth and vertical at the mounting position.
4. Hold the wall and device support to the mounting location and align it with a spirit
level.
5. Mark the holes to be drilled on the wall.
6. Drill the holes with a drill bit appropriate for the wall material and the chosen
screws.
7. Mount the power supply and recharging unit to the wall and device support. The
power supply and recharging unit must not be connected to the mains supply.
8. Screw the wall and device support to the wall with suitable screws.
9. Connect the power supply and recharging unit to the mains supply.
50 Accessories
10. Check whether the charging accessory is correctly attached by installing the device.
» The battery will be charged.
Retrofitting
1. Remove the existing canister system, chapter “3.4 Connection and removal of
canister system and hoses” on page 18.
2. Remove the existing support for the canister system.
3. Attach the new support for the canister system.
4. Insert the new canister system.
Accessories 51
9.0 Spare parts and consumables
Consumables REF
Reusable suction hose, Ø 10 mm 318.1012.0
Fingertip for reusable suction hose, Ø 10 mm, 10 pcs. 318.1100.0
Hydrophobic DDS bacterial and viral filter for ATMOS DDS secretion
340.0054.0
canister, pack of 10 pcs.
Suction hose, disposable, Ø 6 mm, L = 1.30 m, 10 pcs. 006.0057.0
Suction hose, disposable, Ø 6 mm, L = 1.30 m, 50 pcs. 006.0059.0
Serres suction bag 1 l, not autoclavable, 36 pcs.
®
312.0466.0
Medi-Vac® suction bag 1 l, not autoclavable, 50 pcs. 312.0474.0
Vacuum hose for disposable canister system 318.1211.0
Suction catheter Unomedical , size: CH 12, L = 50 cm, 100 pcs.
®
000.0294.0
Suction catheter Unomedical®, size: CH 14, L = 50 cm, 100 pcs. 000.0295.0
Suction catheter Unomedical®, size: CH 16, L = 50 cm, 100 pcs. 000.0296.0
Hydrophobic bacterial and viral filter, Ø 8 mm 443.0738.0
Canister system
Disposable products may not be reprocessed and may not be reused! Please dispose of
disposable products professionally.
The following notes are only applicable for reusable products.
1. Clean and disinfect the reusable products of the canister system.
2. Recycle the disinfected reusable products.
Disposal 53
11.0 Technical data
Device
Dimensions (W x H x D):
with DDS canister system 370 x 277 x 146 mm
with Serres® canister system 370 x 277 x 146 mm
with Medi-Vac® canister system 370 x 277 x 136 mm
with universal bracket 370 x 277 x 136 mm
Weight:
Device with battery / without canister 3.65 kg
system and support
DDS canister system with support for 1.00 kg
DDS canister system
Serres® canister system with support for 0.65 kg
Serres® canister system
Medi-Vac® canister system with support 0.295 kg
for Medi-Vac® canister system
Universal bracket 0.2 kg
Operation:
Temperature range −5 °C up to +50 °C
Relative air humidity 5% to 95% without condensation
Air pressure 540 hPa to 1100 hPa
Transport / storage:
Temperature range −40 °C up to 70 °C
Relative air humidity 5% to 95% without condensation
Air pressure 540 hPa to 1100 hPa
Charging:
Temperature range 0 °C up to 40 °C
Relative air humidity 5% to 95% without condensation
Air pressure 540 hPa to 1100 hPa
Maximum operating altitude 5000 m (NN)
Contamination level Class 1 (fully-sealed housing)
Overvoltage category II
Maximum power consumption 45 W
Maximum current consumption 3.7 A
Mains voltage 12 V DC nominal (at least 10 V, max. 15 V)
at the charging interface or via the power
supply and recharging unit.
Pump Vacuum pump (diaphragm pump), 1 head
Suction capacity at the device inlet 34 l/min ± 4 l/min
(without canister system) at −0.8 bar,
fully recharged battery and 21 °C / 1013
hPa (determined by buffer canister 1 l)
Suction capacity at the inlet of the 30 l/min ± 3 l/min
DDS canister system at −0.8 bar, fully
recharged battery and 21 °C / 1013 hPa
Maximum achievable vacuum 0.8 bar* ± 5% resp. 80% of the air pressure
Vacuum adjustment Via predefined steps: −0,1 bar, −0,2 bar,
−0,5 bar and −0,8 bar, electronically
controlled
54 Technical data
Vacuum display By means of LEDs on the control panel
Display By means of LEDs on the control panel:
on/off, selected vacuum, actual vacuum,
display of battery status, warning (red
LED)
Power cycles (short-term operation) 60 min On, 120 min Off
Noise level: mean sound pressure level at < 60 dB(A)
1 m distance and at −0.8 bar
Classification according to EN 60601-1:
• Protection class against electric shock Protection class II (during mains and
• Degree of protection against electric battery operation)
shock Type BF applied part
Degree of protection against: IP34D
• Ingress of solid foreign objects
• Penetration of dust
• Ingress of water with harmful effects
Periodic tests Recommended: testing every 24 months
Suspension Compatible with ATMOS wall and device
support
Classification according to EN ISO High vacuum / high flow
10079-1
Product class according to Directive IIa
93/42/EEC
UMDNS code 15-016 Suction device, emergency
GMDN code 36616, Suction unit, transport and
emergency
*1 bar = 100 kPa
Battery
Type Lithium-ion; 4INR 19/66-2 US 18650VTC6
Dimensions (W x H x D) 43 x 73 x 75 mm
Weight 0.4 kg
Nominal capacity 6 Ah
Nominal voltage 14.4 V
Charging time Battery status 80%: 3 h 45 min at 20 °C
without operation; battery status 100%:
approx. 5 h 40 min
Automatic switch-over to trickle charging
Recharging interval during long-term Every 6 months
storage
Battery operating time during continuous 85 min at −5 °C
operation with fully recharged battery / 85 min at +21 °C
new battery (>20 l/min, setting −0.8 bar) 42 min at +50 °C
Life cycle Approx. 500 recharging cycles
Display Display of battery status during operation
and recharging
Typical battery operating life* −0.2 bar: 200 min
−0.5 bar: 140 min
−0.8 bar: 85 min
* Measured at +21 °C, continuous operation, without battery recharging and at free air flow.
Technical data 55
DDS canister system
Capacity 1000 ml
Connection reusable suction hose Ø 10 mm I.D.
Reusable suction hose:
Diameter Ø 10 mm I.D.
Length 1300 mm
Connection to the suction device Direct connection (without intermediate hose)
DDS bacterial and viral filter DDS bacterial and viral filter cartridge for use
in the secretion canister lid, single-use product
Bacterial filtration efficiency (BFE) 99.999778%*
Viral filtration efficiency (VFE) 99.73%*
Overall filtration efficiency >99.95%*
Filter class H13 (High-Efficiency Particulate Air/
Arrestance)*
*External test report (test laboratory)
56 Technical data
12.0 Notes on EMC
• Medical electrical equipment is subject to special precautions with regard to EMC and must be installed
according to the following EMC notes.
• Portable and mobile HF communication facilities can influence medical electrical equipment.
• The use of other accessories, other converters and cables than stated may lead to an increased emission
or a reduced interference immunity of the equipment or system.
Electromagnetic Environment –
Immunity Test IEC 60601 Test Level Compliance Level
Guidance
ESD acc. to ± 6 kV contact ± 6 kV contact Floors should be made of wood or
IEC 61000-4-2 concrete or laid with ceramic tiles.
± 8 kV air ± 8 kV air
If floors are synthetic, the relative
humidity should be at least 30%.
Fast electrical ± 2 kV mains ± 2 kV mains Mains power quality should be that
transient/burst IEC of a typical commercial or hospital
± 1 kV I/Os
61000-4-4 environment.
Surges IEC 61000-4-5 ± 1 kV common ± 1 kV common mode Mains power quality should be that
mode of a typical commercial or hospital
± 2 kV differential
environment.
± 2 kV differential mode
mode
Voltage dips, short < 5% UT (> 95% dip of < 5% UT (> 95% dip of Mains power quality should be that
interruptions and the UT for 0.5 cycle) the UT for 0.5 cycle) of a typical commercial or hospital
voltage variations environment. If the user of the
40% UT (60% dip of 40% UT (60% dip of
according to IEC ATMOS E 341 Battery demands
the UT for 5 cycles) the UT for 5 cycles)
61000-4-11 continued operation even in case
70% UT (30% dip of 70% UT (30% dip of of interruptions of the energy
the UT for 25 cycles) the UT for 25 cycles) supply, it is recommended to supply
< 5% UT (> 95% dip of < 5% UT (> 95% dip of the ATMOS C 341 Battery from an
the UT for 5 s) the UT for 5 s) uninterruptible power supply or a
battery.
Magnetic field at 3 A/m Inapplicable Power frequency magnetic
power frequency fields should be that of a
50/60 Hz acc. to IEC typical commercial or hospital
61000-4-8 environment.
NOTE
UT is the AC mains voltage prior to application of the test level.
Notes on EMC 57
Guidelines and Manufacturer’s Declaration – Immunity
The ATMOS E 341 Battery is intended for use in the electromagnetic environment specified below. The
customer or user of the ATMOS E 341 Battery should ensure that it is used in such an environment.
NOTE 1
With 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2
These guidelines may not be applicable in all cases. The emanation of electromagnetic waves is affected by
absorption and reflection of buildings, objects and people.
a
The field strength of stationary transmitters, such as base stations of cellular phones and mobile terrain
radio equipment, amateur radio transmitters, cbm broadcast and TV stations cannot be predetermined
exactly.
To determine the electromagnetic environment in regard to stationary transmitters, a study of the location
is to be considered. If the field strength measured at the location where the ATMOS E 341 Battery is used
exceeds the above compliance level, the ATMOS E 341 Battery is to be observed to verify the intended
function. If abnormal performance characteristics are noted, additional measures may be necessary, such
as reorienting or relocating the ATMOS E 341 Battery.
b
Within the frequency range of 150 kHz to 80 MHz, the field strength should be below 3 V/m.
The ATMOS E 341 Battery may not be used directly next to other devices or piled up with other devices. If
operation next to or piled with other devices is necessary, please watch the device to check its intended
operation in this arrangement.
58 Notes on EMC
Nominal output of the trans- 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
mitter W d = [0.35] √ P d = [0.35] √ P d = [0.35] √ P
0.01 0.035 0.035 0.07
0.1 0.11 0.11 0.22
1 0.35 0.35 0.7
10 1.1 1.1 2.2
100 3.5 3.5 7.0
For transmitters for which the maximum nominal output is not indicated in the above table, the recom-
mended safety distance d in meters (m) can be determined using the equation belonging to the respective
column whereas P is the maximum nominal output of the transmitter in watts (W) acc. to manufacturer’s
specification.
NOTE 1
With 80 MHz and 800 MHz the higher frequency range applies.
NOTE 2
These guidelines may not be applicable in all cases. The emanation of electromagnetic waves is affected by
absorption and reflection of buildings, objects and people.
Notes on EMC 59
ATMOS MedizinTechnik GmbH & Co. KG
Ludwig-Kegel-Str. 16
79853 Lenzkirch / Germany
Phone: +49 7653 689-0
[email protected]
www.atmosmed.com