ATMOS Aspirator

You might also like

Download as pdf or txt
Download as pdf or txt
You are on page 1of 28

English

ATMOS® A 161 /
A 261 / C 161 /
C 261 Aspirator
Operating instructions

GA1GB.310110.0
2017-03 Index: 35 0124
Table of contents

1.0 Introduction................................................................... 3 8.0 Cleaning/Disinfection ........................................... 12-16


1.1 Note of the operating instructions................................... 3 8.1 Basic information........................................................... 12
1.2 Function.......................................................................... 4 8.1.1 Bacterial filter............................................................... 12
1.3 Intended use................................................................... 4 8.1.2 Suction hose, hose connector and vacuum hose........ 12
1.4 Extents of supply............................................................. 5 8.1.3 Fingertip........................................................................ 12
1.5 Transport and storage.................................................... 5 8.1.4 Secretion canister......................................................... 12
1.6 Explanation of symbols.................................................. 5 8.1.5 Canister lid............................................................... 12-13
8.1.6 Device surface ............................................................. 13
2.0 Safety advice................................................................. 6 8.1.7 Rinsing Canister............................................................ 13
8.1.8 Accessories................................................................... 13
3.0 Setting up and starting up............................................ 7 8.2 Oversuction .................................................................. 13
3.1 Operating elements........................................................ 7 8.3 Cleaning instructions..................................................... 13
3.2 Connection...................................................................... 7 8.4 Recommended instrument disinfections..................... 14
3.3 Starting up....................................................................... 7 8.5 Recommended surface disinfections ........................... 14
8.6 Cleaning and servicing plan .................................... 15-16
4.0 General operation ATMOS® A / C 161 / 261 Aspirator.8
4.1 Suction hose................................................................... 8 9.0 Maintenance and servicing........................................ 17
4.2 Adjust vacuum................................................................. 8 9.1 Maintenance and servicing........................................... 17
4.3 Suction procedure.......................................................... 8 9.2 Reprocessing................................................................ 17
4.4 Hose rinsing................................................................... 8 9.3 Sending in the device.................................................... 17
5.0 Operation ATMOS® A / C 161 / 261 Aspirator / DDS.... 9 10.0 Trouble-shooting......................................................... 18
5.1 DDS canister and bacterial filter..................................... 9
5.2 Insertion of the DDS canister.......................................... 9 11.0 Accessories, consumables,....................................... 19
5.3 Connect hose.................................................................. 9 spare parts
11.1 Accessories................................................................... 19
6.0 Operation Receptal®.................................................... 10
11.2 Consumables................................................................ 19
6.1 Holder for Receptal® secretion canister........................ 10
11.3 Spare parts.................................................................... 20
6.2 Assembling the Receptal® secretion canister set......... 10
6.3 Connect hose................................................................ 10
12.0 Technical specifications............................................. 21
7.0 Operation Medi-Vac® / Serres®.....................................11
7.1 Holder for Medi-Vac® secretion canister.........................11 13.0 Checking / Reprocessing / Disposal......................... 22
7.2 Assembling the Medi-Vac® secretion canister set......... 11 13.1 Checking ATMOS® suction devices............................... 22
7.3 Connect hose................................................................ 11 13.2 Reprocessing................................................................ 22
7.4 Holder for Serres® secretion canister.............................11 13.3 Disposal........................................................................ 22
7.5 Assembling the Serres® secretion canister set............. 11
7.6 Connect hose................................................................ 11 14.0 Notes on EMC.............................................................. 23

Further information, accessories, consumables and


spare parts are available from:

ATMOS
MedizinTechnik GmbH & Co. KG
Ludwig-Kegel-Str. 16
79853 Lenzkirch
Deutschland / Germany
Telefon: + 49 7653 689-0

Fax:
+ 49 7653 689-392 (Vertrieb Inland)
+ 49 7653 689-391 (Export)

e-mail: atmos@atmosmed.de
Internet: http://www.atmosmed.de

2
1.0 Introduction
1.1 Notes on operating instructions

These operating instructions contain important notes on how to operate the ATMOS® A / C 161 /
261 Aspirator safely, correctly and effectively. Their reading helps to avoid risks, and also to reduce
repair costs and down-time. That increases, amongst other things, the reliability and service-life of
the device.
These operating instructions serve not only for new operating personnel to be instructed in its use,
but also for use as a reference manual.
These operating instructions must always be kept available near the device.

Care and period tests in conjunction with professional execution provide for operational safety
and readiness for use of your ATMOS® A / C 161 / 261 Aspirator and are therefore a must besides
regular cleaning.
Repair work and period tests may be carried out only by expert personnel authorised by
ATMOS. By applying only original spare parts you will have the guarantee that operational safety,
readiness for work and the value of your ATMOS® A / C 161 / 261 Aspirator will be preserved..

§
● The product ATMOS® A / C 161 / 261 Aspirator bears CE marking CE according to the EC
guideline of the council for medical products 93/42/EEC and meets the basic requirements
of annex I of this guideline.
● The product ATMOS® A / C 161 / 261 Aspirator complies with all applicable requirements of the
directive 2011/65/EC restricting the use of certain hazardous substances in electrical and
electronic equipment (“RoHS”).
● The declaration of conformity and our general standard terms and conditions can be obtained on
our website at www.atmosmed.de.
● The quality management system applied at ATMOS has been certified according to international
standards EN ISO 13485.
● Prior to start-up please peruse chapter 2.0 „For your safety“, in order to be prepared for any
possible dangerous situations.
● These operating instructions correspond to the design of the ATMOS® A / C 161 / 261 Aspirator and
the status of basic safety engineering standards on going to press.
● Reproduction of these instructions – even in part – only with the written permission of ATMOS.
● Subject to alterations and changes.

These operating instructions are valid for the following devices:

• ATMOS® A 161 Aspirator / DDS REF 313.0200.0 • ATMOS® C 261 Aspirator / DDS REF 313.0100.0
with 1 l DDS secretion canister with 1 l DDS secretion canister
• ATMOS® A 261 Aspirator / DDS REF 313.0300.0 • ATMOS® C 261 Aspirator / Receptal® REF 313.0165.0
with 1 l DDS secretion canister
with 1.5 l Receptal® canister
• ATMOS® C 161 Aspirator / DDS REF 313.0000.0
• ATMOS® C 261 Aspirator / Medi-Vac® REF 313.0102.0
with 1 l DDS secretion canister
with 1 l Medi-Vac® canister
• ATMOS® C 161 Aspirator / Receptal® REF 313.0065.0
• ATMOS® C 261 Aspirator / Serres® REF 313.0103.0
with 1.5 l Receptal® canister
with 1 l Serres® canister
• ATMOS® C 161 Aspirator / Medi-Vac® REF 313.0002.0
with 1 l Medi-Vac® canister
• ATMOS® C 161 Aspirator / Serres® REF 313.0004.0
with 1 l Serres® canister

Please store this document near the device for later use!

3
1.0 Introduction
1.2 Function
The ATMOS® A / C 161 / 261 Aspirator is a very handy small suction unit.
   It is driven by an electromotive, maintenance-free diaphragm-type pump.
During operation, the pump generates a vacuum within the hose system
 and the collection canister, thus sucking off secretions or fluids (e.g. by
means of a suction catheter).
The fluid is gathered in the collection canister.

Valid for ATMOS® C 161/ 261 Aspirator


The final vacuum and, following, the air-flow rate can be adjusted by me-
ans of the fine control and the vacuumgauge. An overtemperature stop
controlled by electronics avoids overheating of the unit.

Valid for ATMOS® A 161/ 261 Aspirator


The final vacuum and, following, the air-flow rate can be adjusted by
means of 3 step vacuum regulation. An overtemperature stop controlled
by electronics avoids overheating of the unit.

Valid for ATMOS® A / C 161 / 261 Aspirator / DDS:


The reusable secretion canister is connected to the pump housing via
direct-docking, without any pedestrian hose system. Only the suction
hose has to be plugged in by the user.

Fig 1a. A bacterial filter, located in the lid of the secretion canister, avoids ente-
ring of bacterias and liquids into the pump interior. A mechanical over-
ATMOS® C 161 / 261 Aspirator / DDS suction stop integrated in the canister lid additionally avoids accidentally
 Sliding cover absorption of secretion into the pump head.
 Vacuum adjustment (individually adjustable)
 Vacuum gauge
 Hose storage

  1.3 Intended use


Name: ATMOS® A 161 Aspirator / ATMOS® A 261 Aspirator
ATMOS® C 161 Aspirator / ATMOS® C 261 Aspirator
Main functions: Temporarily and spontaneously suction of secretions,
blood and body fluids which typically accumulate during respiratory tract
suction and ENT treatment.
Med. indications/ application: Suction of the upper respiratory tract and
throat, nose, ear
Specification of the main function: Drainage and temporarily collection
of body fluids. By means of an electrical suction pump, a negative pressure
will be created. The integrated secretion canister allows a temporarily col-
lection of the derived body fluids.
Application organ: Upper respiratory tract (oral cavity, nasopharyngeal
cavity and bronchial system) and throat, nose, ear
Application time: Temporary use on the patient during respiratory tract
suction (< 60 min.) or short-term use at ENT treatment (up to 30 days).
Application site: The application site of respiratory tract suction is the
Fig 1b. clinical, practices, nursing and home care sector. In ENT medicine the
devices are used in clinic and practice. The application of the device may
ATMOS® A 161 / 261 Aspirator / DDS only be performed by medical trained and introduced staff.
 Vacuum adjustment (3-step adjustment) Contraindications: Not adapted for:
 Hose storage • the continuous operation in case of drainages in the low vacuum range
(e.g. thoracic drainage or wound drainage).
• permanently endoscopic use.
• the use outside of the medical sector.
• the suction of flammable, corrosive and explosive substances.
• the suction in explosion-risk areas.

!
The product is: x active □ not active
Sterility: The device is not sterile.
Single use product / reprocessing: The device and parts of the acces-
sories are reusable, for information on reprocessing and disinfection please
see the operating instructions.

4
1.0 Introduction
1.4 Scope of supply
● Prior to dispatch, this ATMOS device was subjected to an extensive functional test and has been carefully packed.
Nevertheless, please compare the contents of the shipment on completeness immediately upon receipt (see delivery note).
In addition to the basic device, the scope of delivery comprises the following parts:

DDS Medi-Vac® Receptal® Serres®

Grad. secretion Medi-Vac® Receptal® Serres®


canister (1 l) canister (1 l) canister (1.5 l) canister (1 l)

Lid for secretion Medi-Vac® Receptal®


canister with suction bag (1 l) suction bag (1.5 l)
triple oversuction with integrated with integrated Serres®
safety bacterial filter bacterial filter suction bag (1 l)
C 161 Battery
2 DDS
bacterial filter
C 161 Battery
1 DDS bacterial
filter Support Support Support

ATMOS® A / C 161 / 261 Aspirator, scope of supply of all versions:


silicone
suction hose mains cable for
Ø 6 mm, L = 1.30 m 230 V~/50-60 Hz

1.5 Transport and storage


● The transport of the device may be effected only in a dispatch ● Ambient conditions:
carton upholstered and offering sufficient protection.
Transport/Storage: -30...+50°C;
● Please document and report damages in transit immediately.
For complaints or return deliveries, please use the enclosed 5...90 % humidity
form QD 434. non-condensing
at air pressure 700...1060 hPa
● The unit must be allowed to stand for up to six hours at room
temperature prior to starting up for the first time following Operation: +10...+35°C;
transport at temperatures below freezing. The unit may not 20...80 % humidity
be operated if it has not acclimatised as this might damage its non-condensing
diaphragms. at air pressure 700...1060 hPa

1.6 Explanation of symbols

i
The CE sign shows that this
Important information! Application part type BF product meets the appropriate
0124
requirements of the EC
Warning, special diligent Serial number guidelines.
SN
notice!
ON (feed-in,
REF Order number
power connection)
Protection class II
Creation date
OFF (feed-in,
Fuse power connection)
Refer to operating
instructions.
IP 21 Protection against the ingress of
Follow operating - solid foreign objects Ø ≥ 12.5 mm
- vertically dripping water
instructions! (blue)

5
2.0 For your Safety
● Prior to starting up the ATMOS® A / C 161 / 261 ● The safety standard of the ATMOS® A / C 161
Aspirator, read these operating instructions / 261 Aspirator corresponds with recognized
carefully. medical technical regulations and the direc-

!
tions of the law relating to medical products.
● ATMOS cannot guarantee perfect
functioning neither will it be liable for ● The electrical outlet is in fact carried out three-
damage to people or property if: pole, but the middle contact pin (normally ground
• Any non-original ATMOS parts are wire connection) in the interior of the unit is not
used, connected.
• the user instructions given in this
manual are not followed exactly or ● This product is not re-sterilisable. Repeated
are disregarded, reuse of components which are marked with
General safety • Assembly, resetting, alterations, a 2 is forbidden. In case of repeated reuse
information extensions and repairs are not carried these components lose their function and there
out by people authorised by ATMOS. is a high infection risk.
● Use transparent hoses exclusively.
● No warranty rights shall exist in the event
● The ATMOS® A / C 161 / 261 Aspirator may be op- of damage or failure caused by the use of
erated only in rooms used for medical purposes, non-ATMOS® accessories or non-ATMOS®
but not in areas subject to explosion hazards and consumables
in oxygen rich environments.

● Only persons instructed in medical use may ● The suction hose must never come into direct
apply the ATMOS® A / C 161 / 261 Aspirator to contact with the application site.
patients. Always use a sterile suction catheter resp. a
medical accredited aspiration set.
● The ATMOS® A / C 161 / 261 Aspirator has
been designed for aspirating body fluids in ● This suction unit may not be applied without
medical ranges. Never remove explosive disposable bacterial filter plate.
gases and inflammable or corrosive fluids.
● Always remove the plug from the wall socket
● Sterile packed parts may no longer be used if first in order to disconnect the unit from the
their packing was damaged during transport or mains. Only then may the connecting cable be
storage. disconnected from the unit:
Danger of injury!  Danger of infection for the patient. • Before cleaning the unit,
• before the collection canister is evacuated,
● The unit may not be operated in splash water • before leaving the room.
range. Never pull at the cable!
Never touch the plug or cable with wet hands.

●The unit may not be started: ● Do not allow any liquid to get into the unit. If
• If cables or plugs are defective, liquid has penetrated the unit, it may not be
• if it has been dropped down before, operated again until it has been checked by
• if obvious defects might restrict safe the customer service centre.
operation.
Prior to returning the device for repair, clean it. ● The unit must be set up on a firm, level sur-
face. The switched-on unit might get overheat-
● Pay attention to the ambient conditions de- ed if it is placed on an uneven surface (e.g.
scribed in chapter 1.5 Transport and storage. mattress, cushion, padded seat etc.).
Danger to the
device ● The unit must be checked periodically on its ● The main voltage specified on the type plate
function and safety deficiencies, e.g. pins, must match the power supply system.
secretion canister, housing, etc.
● Never connect the unit to defective power
● The unit, collection canister, mains cable, acces- sockets or extension cables.
sories, connection cables and hoses must be Avoid moisture on plug and switches.
checked for damage prior to starting up. Dam-
aged cables and hoses must be replaced imme-
diately. Prior to use, check the unit functions.

6
3.0 Setting up and starting

3.0 Setting up
 Set up the device on a level, firm surface.

3.1 Operating elements

1 Shove blind for covering the operating elements


(ATMOS® C 161 / 261 Aspirator)
2 Vacuum adjustment
3 Vacuum gauge (ATMOS® C 161 / 261 Aspirator)
4 Hose storage (fig. 1, page 4)
5 Suction hose storage (accessory)
6 Switch On I / Off O

1 2 3 5 6

Fig 2a. Fig 3.


3.2 Connection
2
The main voltage specified on the type plate must match
the power supply system.

i Check mains cable for damages. Damaged cables must be


replaced immediately!

3.3 Starting up
Fig 2b. ● The ATMOS® A / C 161 / 261 Aspirator is delivered
ready for use.

● Lift the unit out of the cardboard. Check whether the


voltage values on the data plate correspond with the
inbuilding voltage.

● Set up the device on a level, firm surface.

● Prior to first operation, pay attention to the safety


information in chapter 2.0.

Fig 4. ● The unit must be allowed to stand for up to six hours


at room temperature prior to starting up for the first
time following transport at temperatures below
freezing. The unit may not be operated if it has not
acclimatised as this might damage its diaphragms.

● ATMOS® A / C 161 / 261 Aspirator / DDS: Always hold


ready at least one ATMOS® DDS bacterial filter, as
the device may not be operated without one!

Fig 5.

7
4.0 General operation

Prior to these notes please read the foregoing chapter of your respective version of the ATMOS® A / C 161 / 261 Aspira-
tor!

● Attention: Suction procedures in the ● Check the vacuum readout regularly!


respiratory tract may only be
● If secretion has been soaked up into the

!
implemented after appropriate instruction
by hospital or special staff. pump due to improper use or manipulation,
the device must be repaired from ATMOS
● Make sure that the collection canister or a service authorised by ATMOS.
is evacuated in time. As soon as the
canister is half-filled, it must be emptied ● For aspiration use only applicable suction
(this principle proves right in all application catheters, attachments or a medical aspira-
ranges). tion sets.
Important
notes on safety ● When the maximum level is exceeded, ● Whilst aspirating please pay attention to the
the overflow safety reacts and suction is filling level of the secretion canister.
stopped. Empty the canister.

4.1 Suction hose


● Join the suction hose ( 7 ) and the suction catheter (10 ) by means of the fingertip (not included in delivery) (9 ).

4.2 Adjust vacuum


● Only for C 161 / 261 Aspirator
Adjust your desired vacuum by closing finger tip ( 9 ) and
auxiliary air vent ( 8 ). The vacuum is then generated. 7 8
Open the regulating valve / vacuum adjustment (page 4,
) until the vacuumgauge shows the desired vacuum
value

● Only for A 161 / 261 Aspirator


Adjust your desired vacuum by turning the three-steps 9 10
adjustment (page 4, ) to the suitable position. 7 Suction hose
-25 kPa* low, -55 kPa*medium, -75 kPa* high 8 Auxiliary air vent
* depends on daily atmospheric pressure and ambient condi- 9 Finger tip
tions 10 Suction catheter
● Choose a suction catheter of the right size (10 , which are Fig 6.
available from ATMOS in 3 different sizes) or a suction
instrument which is only available from specialized dealers.

!
AUXILIARY AIR VENT OPEN =
suction procedure is interrupted (e.g. when leading in the catheter)

AUXILIARY AIR VENT CLOSED WITH THE FINGER = suction

4.3 Suction procedure 4.4 Hose rinsing


● Then, lead in the catheter in the same way as shown by ● Dispose the suction catheter and rinse the
your hospital staff and start the suction procedure. suction tube with clean water or disinfec-
tion liquid after every suction procedure. We
recommend to use the rinsing bottle in which
● Control the suction procedure with the auxiliary air vent you can carry clean water along with you.
( 8 ) on the fingertip.

 The hydrophobic DDS bacterial filter / oversuction stop


avoids ingress of moisture. Nevertheless you should empty
the canister at a fill level of 1/2.

● The secretion canister system is designed the way that


secretions flows laterally to the wall. Therefore the foam
formation in the canister is reduced.
8
5.0 Operation DDS

● Do not operate the device without a ● Exchange the bacterial filter when chang-
bacterial filter. We recommend you ing the patient. ATMOS recommends:
always to store at least one spare Replace the bacterial filter after 14 days,

!
bacterial filter. even if there is no patient change.
● Always wear disposable gloves when ● Vacuum connection
changing the bacterial filter! Direct-Docking-System
The vacuum connection between the pump
● Prior to each use please check wheth- and the collection canister is created au-
er the bacterial filter is dry and clean. tomatically as soon as the DDS canister is
Important Replace the bacterial filter with a new positioned correctly.
notes on safety for the filter if it is discoloured, contaminated
or oversucked. A bacterial filter may
DDS canister system never be reused

5.1 DDS canister and


DDS bacterial filter

  With the DDS collection canister on a firm surface, position


the lid horizontally on top (the lid may not be twisted!)

 Press down lightly onto the collection canister using both


hands until limit is reached (Fig 7).

Fig 7.

5.2 Insertion/Removal of the


DDS canister

 The filter must be fixed to the housing. Afterwards the


secretion canister is inserted. For insert the DDS collec-
tion canister, shift it horizontally onto the bacterial filter; for
Fig 8.
removal, pull it horizontally outside (Fig 8).

Please note that this order is strictly observed otherwise


! power loss of the device could be the consequence!

i If required the canister can be ejected even easier from


the device by means of a lever instrument (e.g. plain
spattle); see Fig. 9.
Tip

Fig 9.

5.3 Connect hose


  Press the required DDS hose adapter with 6 or 10 mm
diameter into the hole of the DDS collection canister lid
twisting slightly to ensure a tight fit (Fig 10).

 Twist slightly in the same manner when removing.

Fig 10.

9
6.0 Operation Receptal®

6.1 Holder for Receptal® secretion


canister
Plug the screw thread of the holder from the top into the
borehole at the bottom side of the device.
Screw it together with the provided screw nut.

Fig. 11.

6.2 Assembling the Receptal®


Receptal® bag secretion canister system

Insert the Receptal® bag into the Receptal® canister.

Close the canister tightly at all sides.


i Check again for density, otherwise no vacuum can
be built up.

Insert the vacuum hose.

! Only bags with integrated bacterial filter may be used!

Receptal® canister

Fig 12.
11 12 13

6.3 Connect hose

11 Vacuum channel
12 Vacuum hose
13 Connection for vacuum hose

The secretion is sucked off through the vacuum


channel.

Fig. 13.

!
● Sterile packed parts may no longer be ● Only use secretion bags with integrated
used if their packing was damaged during bacterial filter!
transport or storage A bacterial filter avoids divulgement of
 Danger of infection for the patient. bacterias.

10
7.0 Operation Medi-Vac® and Serres®

Medi-Vac® bag
7.1 Holder for Medi-Vac® secretion
canister
Plug the screw thread of the holder from the top into the
borehole at the bottom side of the device.
Screw it together with the provided screw nut.

7.2 Assembling the Medi-Vac®


secretion canister system
Medi-Vac® canister Insert the Medi-Vac® bag into the Medi-Vac® canister.
Fig. 14. Fig.15. Close the canister tightly at all sides.

11 12 13
i Check again for density, otherwise no vacuum
can be built up.

Insert the vacuum hose.

! Only bags with integrated bacterial filter may be used!

7.3 Connect hose

11 Vacuum channel
12 Vacuum hose
13 Connection for vacuum hose

Fig. 16.

7.4 Holder for Serres® secretion


canister
Plug the screw thread of the holder from the top into the
borehole at the bottom side of the device.
Screw it together with the provided screw nut.

7.5 Assembling the Serres® secretion


canister system
Insert the Serres® bag into the Serres® canister.
Close the canister tightly at all sides.
Fig. 16a. Fig. 16b. i Check again for density, otherwise no vacuum
can be built up.
11 12 13
Insert the vacuum hose.

Only bags with integrated bacterial filter may be used!


!

7.6 Connect hose

11 Vacuum channel
12 Vacuum hose
13 Connection for vacuum hose

Fig. 16c.

11
8.0 Cleaning / Disinfection
● In case the parts are used in one patient only
The way the suction device is used determines its reliability and ! we recommend an exchange every 4 weeks.
safety. These hygiene measures are indispensable for protecting ● In addition we recommend to thoroughly rinse
the patient and the user and for maintaining a safe and reliable hose, hose connector and vacuum hose with clear
suction device. water and to disinfect them at least once a day as
When the suction device is used on another patient or in case described above.
the device has been oversucked a professional reprocessing
by the manufacturer, by a certified ATMOS partner or by a
specialist, who is authorised by ATMOS, in compliance with 8.1.3 Fingertip
Medical Devices Operator Ordinance, Medical Devices Act and
BV-Med rules is required (please see chapter 9.2 reprocessing). ● Fingertip is not included in delivery, please order
separately.
8.1 Basic information ● Prior to using the device in another patient the
fingertip must be exchanged.
● The following cleaning measures must only be performed if the ● In case the device is used in one patient only we
device was used. When the device is only rarely used then a recommend for hygienic reasons the exchange of
function check must be conducted at least every three months. the fingertip every day.
Only when you adhere to these points the function of the device
can be guaranteed.
● We recommend you to document any maintenance work and 8.1.4 Secretion canister
also any exchange of parts.
● Please always wear disposable gloves for any work you ● The secretion canister must always be
perform. disinfected with an instrument disinfectant
● Prior to cleaning the device please remove and dispose all ! recommended on page 14 in case the device is
disposable parts like filter, fingertip and catheter. used in another patient. Prior to disinfection resp.
● Prior to cleaning please remove the mains cable from the autoclaving please take care to empty the canister
device. and to rinse it with clear water in order to increase
● The described measures for cleaning and disinfection cleaning efficiency.
do not replace valid rules for operating the device! Please observe the instructions for use of the
● Please observe the instructions for use prescribed by the relevant disinfectant solution!
manufacturers of disinfectants. Especially regarding ● In case the device is used in one patient only we
concentration and regarding their suitability for use. recommend disinfection of the canister every day
● Attention: The lid parts and silicone hoses might get dyed by as described above.
some disinfectants; a fact which does not take effect on the
● For hygienic reasons we recommend to empty the
attributes of the materials.
secretion canister after every suction procedure
● Basically all parts (canister, cover, overflow safety and
and to rinse it with clear water.
hose) which come into contact with suction material must be
 Information on how to remove the canister you
cleaned and disinfected. Single-use parts like, for example,
will find in chapter 5.2 on page 9.
filters, catheter, fingertip... must be exchanged as soon as
the device is used in another patient. Please see the different
instructions for cleaning (chapter 8.3).
● In case the suction device is used in one patient only device
and accessories should, for hygienic reasons, be cleaned
and disinfected. Please see the different instructions for
cleaning (chapter 8.3).
● Cleaning in an automatic cleaner and disinfector is also possible
(hose connector, secretion canister and canister lid).
Thermal disinfection is carried out at 93° C.
Fig 17.
8.1.1 Bacterial filter
● Exchange the bacterial filter when changing the patient. ATMOS
recommends: Replace the bacterial filter after 14 days, even if
there is no patient change.
8.1.5 Canister lid
● Replace the bacterial filter with a new filter if it is discoloured,
contaminated or oversucked. ● The canister lid must always be disinfected with an
● Pay attention to storing a sufficient number of replacement instrument disinfectant recommended on page 14 in
bacterial filters. case the device is used in another patient. Prior to
disinfection please take care to remove the bacterial
8.1.2 Suction hose, hose connector and filter from the lid and to disassemble the lid into its
single components (lid, float ball and hose
vacuum hose connector). Prior to disinfection or autoclaving the parts
● Suction hose and hose connector must always be disinfected must be rinsed with clear water for at least 10 seconds
! with an instrument disinfectant recommended on page 14 in in order to increase cleaning efficiency. Afterwards the
case the device is used in another patient. Prior to disinfection parts have to be disinfected.
or autoclaving the parts must be rinsed with clear water for at
least 10 seconds in order to increase cleaning efficiency.
Please observe the instructions for use of the relevant
disinfectant solution!
12
8.0 Cleaning / Disinfection
Please observe the instructions for use of the ● The complete surface of the hose rewind, the trolley and the
! relevant disinfectant. device support must always be cleaned with a damp (not wet)
 Information on how to remove the secretion cloth and disinfected with a surface disinfectant stated
canister lid you will find in chapter 5.2 on on page 14 prior to use the device in another patient.
page 9. ● In case the device is used in one patient only the device sur-
● We recommend to thoroughly rinse the lid and its face should be cleaned if it is contaminated however at least
components with clear water after each suction once every week with a damp (not wet) cloth and afterwards be
procedure in case the device is used in one patient disinfected with a surface disinfectant stated on page 14.
only.
Attention! Please remove bacterial filter prior to
! this! 8.2 Oversuction
When is a suction unit oversucked?
A suction device is oversucked if suction material penetrated into
8.1.6 Device surface the interior of the device.
How can one realise that the suction device is contaminated?
● Prior to use the device in another patient the Generally a reduced suction capacity is a sign of possible oversuction.
complete device surface must always be cleaned The ATMOS® C 161 / C 261 Aspirator have a condensate collector
with a damp (not wet) cloth and disinfected with a at the bottom of the device. For visual inspection please remove the
surface disinfection solution stated on page 14. cap. The device is oversucked if humidity or contamination is visible
● In case the device is used in one patient only the in the condensate collector.
device surface should be cleaned if it is Measures
contaminated however at least once every week with The device must be reprocessed by the manufacturer or a certified
a damp (not wet) cloth and afterwards be disinfected ATMOS partner if the device is oversucked or if any reservations exist
with a surface disinfectant stated on page 14. regarding the hygiene condition.
 Discolouration of the surface could occur by some A contaminated suction device bears a risk for the patient as well as
disinfectants; a fact which does not take effect on for the caregiver. Therefore, we recommend regular checking of the
the attributes of the material. condensate collector.
 Prior to cleaning please make sure to disconnect the
! device from the mains! 8.3 Cleaning instructions
 The device may never be autoclaved, rinsed under
! running water or immersed into any liquids!
For use in one
patient
8.1.7 Rinsing Canister
for use in another patient

after suction procedure


● The rinsing canister must always be disinfected
in case the device is used in another patient.

every 2 weeks
every 4 weeks
contamination

Prior to disinfection please take care to empty 1x per week


1x per day

the canister and to rinse it with clear water in


order to increase cleaning efficiency.
● In case the device is used in one patient only
we recommend disinfection of the canister
! every week. Exchange bacterial filter X X X
● The rinsing canister may only be cleaned with a ph Rinsing the suction hose X X
neutral cleaning liquid which does not contain the Disinfecting/autoclaving
following ingredients: X X
the suction hose
ammoniac, amines, amides, phenol derivates, ani-
Exchanging the suction hose X
onic tensides.
● The disinfection is exclusively allowed with disinfect- Exchanging the fingertip X X
ant which does not contain the following ingredients: Emptying the secretion canister X X
alcohol, aromatic hydrocarbons, ammonia, amine. Rinsing the secretion canister X X
● Cleaning in a dishwasher is possible when using ph
Disinfecting the secretion canister X X
neutral cleaning liquids (5 cycles).
Rinsing the lid components X X
Disinfecting the lid components X X
8.1.8 Accessories Cleaning of the device surface X X X
● Hose rewind (313.0007.0) / Wipe disinfection of the
X X X
Trolley (320. 0070.0) / device surface
Device support (313.0012.0) Rinsing the vacuum hose X X
Disinfection of the vacuum hose X X
Disinfection of the hose connector X X

13
8.0 Cleaning

8.4 Recommended disinfectants for instruments


Disinfectant Contents (in 100 g) Manufacturer

GIGASEPT FF Succindialdehyde 11.0 g Schülke & Mayr, Norderstedt


(Application concentrate) Dimethoxytetrahydrofurane 3.0 g not for rinsing canister
Corrosion inhibitors
Non-ionic tensides and fragrances

Sekusept PLUS1 Glucoprotamine 25.0 g Ecolab, Düsseldorf /
not for rinsing canister
(Application concentrate) Non-ionic tensides
Solvents, complexing agents

8.5 Recommended disinfectants for surfaces


Disinfectant Contents (in 100 g) Manufacturer

ATMOS® Green & Clean SK Alkyldimethylbenzylammoniumchloride <1 g Metasys, Rum (Austria)


(application solution) Dialkyldimehtylammoniumchloride <1 g
Alkyldimethylethylbenzylammoniumchloride <1 g

Dismozon pur Magnesium peroxyphthalate Bode Chemie, Hamburg


(granulate) Hexahydrate 80 g
End of product 12/2014

Dismozon plus Magnesium peroxyphthalate Bode Chemie, Hamburg


(granulate) Hexahydrate 95.8 g

Kohrsolin FF Glutaral 5g Bode Chemie, Hamburg


(application solution) Benzyl-C12-C18-alkyldimethyl- 3g not for rinsing canister
ammoniumchloride
Didecyldimethylammoniumchloride 3g

Mikrozid sensitive wipes Quaternary Ammonium compounds 0.26 g Schülke & Mayr, Norderstedt

Perform Pentakalium bis(peroxymonosulphate)- Schülke & Mayr, Norderstedt
(application solution) bis(sulphate) 45.0 g

Bacillol 30 Foam Ethanol 14.0 g Bode Chemie, Hamburg


Propan-2-ol 10.0 g not for rinsing canister
Propan-1-ol 6.0 g
Alkylamino-
propylglycine <1g

Mikrobac forte Benzyl-C12-C18-alkyldimethyl- 19.9 g Bode Chemie, Hamburg


ammoniumchloride
N-(3-Aminopropyl)-N-dodecylpropan
1.3-diamin

Discolouration may result if disinfectants containing aldehydes and amines are used on the same object.

14
Cleaning and servicing plan for ATMOS® A 161 / A 261 / C 161 / C 261 Aspirator
start date: name of the item: serial number:

cleaning cleaning cleaning exchange of cleaning/exchange performed


exchange of exchange
day secretion canister of the suction hose,
bacterial filter of fingertip name signature
canister lid housing 1.3 m

exchange* exchange* exchange*

exchange

exchange

exchange

exchange

exchange

exchange

exchange

exchange
daily, respectively after each use

daily, respectively after each use


daily, respectively after each use

exchange

exchange

exchange

exchange

exchange

exchange

exchange exchange

exchange

exchange

exchange

exchange

exchange

exchange

exchange

exchange

exchange

exchange

exchange

exchange

exchange

exchange

* Before first time operation of a brand new device, respectively a technically as well as hygienically proper device.
Special notes: other products must be avoided. The intervals stated in the list are non-bin-
Before operating the suction device, the user has to make sure that the device ding guide values. Depending on the use shorter intervals may be necessary.
functions and is in good order and condition. The user has to observe the
instructions in the operating manual as well as all other safety-related and For each patient a new or technically as well as hygienically proper suc-
maintenance information enclosed. tion device must be used. Otherwise there is high and acute danger of
infection for the patient, the user and any third person!
For cleaning and disinfection only agents which are recommended by the ma-
nufacturer, may be used.
Only sterile, single-use suction catheters may be used for suctioning. They
have to be exchanged before each suction process. During use utmost atten- ATMOS MedizinTechnik GmbH & Co. KG
tion to hygiene (e.g. disinfection of hands, wearing single-use gloves) is indis- Ludwig-Kegel-Straße 16 / D-79853 Lenzkirch
pensable. After each use the secretion canister and the hose must be rinsed Phone: +49 (0)7653-689-0 / Fax: +49(0)7653-689-292
thoroughly with water. During storage the contamination of the device and www.atmosmed.de / e-mail: atmos@atmosmed.de
Important notes
General information Bacterial filter
The way the suction device is used determines its reliability and safety. The bacterial filter prevents penetration of micro organisms and secre-
These hygiene measures are indispensable for protecting the patient tion into the device, respectively blowing out from it and is therefore a
and the user and for maintaining a safe and reliable suction device. protection for the user and the device. Replace the bacterial filter with
a new filter if it is discoloured, contaminated or oversucked. Exchange
If there is a change of patient or ownership then the device must
the bacterial filter when changing the patient. ATMOS recommends:
be reprocessed acc. to Medical Devices Operator Ordinance, Me-
Replace the bacterial filter after 14 days, even if there is no patient
dical Devices Act and BVMed guidelines. An oversucked (conta-
change. In order to increase the service life of bacterial filters, it is re-
minated) device must be repaired by the manufacturer, by a certi-
commended to empty the secretion canister when it is half-full. Always
fied ATMOS partner or an ATMOS authorized, specialized dealer.
use the original ATMOS® bacterial filter
This cleaning and servicing plan as well as the relevant notes result  The suction device may not be operated without bacterial filter!
from many years of experience. Depending on the use and the user’s
experience shorter intervals may be necessary. Hose connection/fingertip

ATMOS recommends the following sets of consumables: The fingertip connects the suction hose to the suction catheter. As the
fingertip is in direct contact with secretion and it is difficult to clean, we
According to this cleaning and servicing plan the following consumab- recommend a daily exchange. When the device is used for another
les have to be changed: patient the fingertip must be exchanged immediately.
Suction Hose
bacterial filter
The suction hose conducts the secretion from the suction catheter to
the canister. In order to prevent secretion from drying, the hose must
be thoroughly rinsed with clear water after each use. The water can
be sucked into the secretion canister. Please fill the secretion cani-
fingertip ster only half. Frequent cleaning and disinfection may discolour and
embrittle the hose. Therefore, a monthly exchange of the suction hose
is recommended.

Cleaning of the device (housing)


When the device is contaminated but at least once per week the hou-
sing must be wiped off with a moist (but not wet) cloth. A weekly dis-
Suction hose
1.3 m infection is recommended.
 Never irrigate the device with water and never emerge it into any
liquid.

suction catheter, length: 50 cm Cleaning/disinfection


To improve the cleaning effect, standard washing-up liquid can be ad-
ded to the warm water. In the case of tenacious contamination the
parts should be steeped in water for a length of time or they may be
white Ø 4 mm removed with a soft brush or cloth. After thorough cleaning, canister,
fingertip and hoses can be disinfected with a disinfection agent (see
green Ø 4.7 mm operating instructions).

orange Ø 5.3  Cleaning in an automatic cleaner and disinfecter is also possible


(hose connector, secretion canister and canister lid).
Thermal disinfection is carried out at 93° C.

 Disconnect the mains plug from the socket before commencing


with cleaning and disinfection!
 Please observe the notes in the operating instructions, especially
regarding the recommended agents.

Cleaning of the secretion canister


Please empty the secretion canister after each use, rinse it thorough-
ly with clear water and clean it with washing-up liquid. Tenacious
contaminations can be removed with a standard bottle brush.

Cleaning of the canister lid


The bacterial filter must be removed before cleaning, please use
single-use gloves. Please demount the canister lid after each use and ATMOS MedizinTechnik GmbH & Co. KG
rinse it thoroughly. The lid must be absolutely dry before reuse. Please Ludwig-Kegel-Straße 16 / D-79853 Lenzkirch
pay attention to a correct function of the overflow safety when moun- Telefon: +49 (0)7653-689-0 / Fax: +49(0)7653-689-292
ting the lid. www.atmosmed.de / e-mail: atmos@atmosmed.de
9.0 Maintenance
9.1 Basic information 9.2 Reprocessing
● Carry out a visual inspection of the unit prior to each The way the suction device is used determines its
use including hoses, collection canister and connec- reliability and safety. These hygiene measures descri-
tion cable. Damaged cables and hoses must be bed in the last chapter are indispensable for protecting
replaced immediately. the patient and the user and for maintaining a safe and
reliable suction device.
● Maintenance, repairs and period tests may only be When you can ensure the device was not
carried out by persons who have the appropriate oversucked then perform a reprocessing
technical knowledge and are familiar with the product. acc. to Medical Devices Operator Ordinance,
To carry out these measures the person must have the Medical Devices Act and BVMed guidelines.
necessary test devices and original spare parts. The reprocessing consists of cleaning,
ATMOS recommends: work should be carried out by surface disinfection as well as the exchange of
an authorized ATMOS-service partner. This ensures consumables. An ATMOS® set of consumables is
available for this purpose.
that repairs and testing are carried out professionally,
If you cannot exclude that the device was
original spare parts are used and warranty claims
oversucked then the device must be repaired by
remain unaffected. the manufacturer, by a certified ATMOS partner
or an ATMOS authorized, specialized dealer.
● Please comply with the country-specific guidelines Subsequently the device may be operated again.
regarding regular testing especially for the electrical
safety. ATMOS recommends a test every 24 months. When is a suction unit oversucked?
A suction device is oversucked if suction material
● For repair, this device can be returned to ATMOS. penetrated into the interior of the device.
How can one realise that the suction device is
● Before returning the device for repair, clean and after- contaminated?
wards disinfect all secretion canister parts and hose Generally a reduced suction capacity is a sign of possible
parts. The device´s surface also has to be disinfected. oversuction.
The ATMOS® C 161 / C 261 Aspirator have a condensate
collector at the bottom of the device (fig 14 ). For visual
● ATMOS cannot guarantee perfect functioning neither
inspection please remove the cap. The device is
will it be liable for damage to people or property if: oversucked if humidity or contamination is visible in the
• Any non-original ATMOS® parts are used, condensate collector.
• the user instructions given in this manual are not
Measures
followed exactly or are disregarded,
The device must be reprocessed by the manufacturer or
• assembly, resetting, alterations, extensions and a certified ATMOS partner if the device is oversucked or
repairs are not carried out by people authorised by if any reservations exist regarding the hygiene condition.
ATMOS. A contaminated suction device bears a risk for the patient
as well as for the caregiver. Therefore, we recommend
● No warranty rights shall exist in the event of damage regular checking of the condensate collector.
or failure caused by the use of non-ATMOS® accesso- 14
ries or non-ATMOS® consumables.
condensate
● In order to protect the user, the ATMOS® A / C 161 Bat- collector for a
tery must be in good condition with regard to technics quick view control
and hygiene prior to passing on. If there is a change of of a possible
patient or ownership then the device must be repro- contamination
cessed acc. to Medical Devices Operator Ordinance,
Medical Devices Act and BVMed guidelines. An over-
sucked (contaminated) device must be repaired by 9.3 Sending in the device
the manufacturer, by a certified ATMOS partner or an
1. Remove and properly dispose of consumables.
ATMOS authorized, specialized dealer.
2. Clean and disinfect the products and accessories
according to the operating instructions.
● Pay attention to regulations and instructions valid for
3. Place used accessories with the device.
the respective application range.
4. Fill in the form QD 434 „Delivery complaint / return
shipment“ and the respective Decontamination certi-
ficate.
• This form is enclosed to each delivery and can be
found at www.atmosmed.com.
5. The device must be well padded and packed in suitable
packaging.
6. Place the form QD 434 „Delivery complaint / return
shipment“ and the respective decontamination certifi-
cate in an envelope.
7. Affix the envelope to the outside of the package.
8. Send the product to ATMOS or to your dealer.

17
10.0 Trouble-shooting

Prior to dispatch, the ATMOS® A / C 161 / 261 Aspirator was subjected to an extensive functional test. If, nevertheless, a failure
should appear, you may possibly clear it yourself if you follow these notes:

Problem Possible causes Remedy


● Unit does not start – Discharged battery – Connect the battery charging
power pack to the device. The
battery should be recharged for
1 – 2 hours prior to operation
with battery.
– Loose power plug of the charging device – Check all plug and socket
connections. Pay attention to the
control lamp, it must be
illuminated when all connections
are o.k.
● Insufficient performance – Discharged battery – Recharge the battery.

– Filter is blocked – Exchange the filter.

● 1. Low or no vacuum – 1.1 DDS bacterial filter is missing – Insert DDS bacterial filter
is indicated

– 1.2 Leakages within the hose system – Check collection canister lid and
or in collection canister lid hose system on tight fitting.

– Connect the filter once again to


the connection nozzle.

– Check the suction lid on tight


and correct fitting.

– 1.3 Secretion or blood has been – Unit has to be returned for repair.
sucked in and valve plates of
the pump are contaminated

● 2. High vacuum is – 2.1 DDS bacterial filter is blocked. – Exchange DDS bacterial filter
indicated
– 2.2 Float of overflow safety closes – Check collection canister inlet; if
the collection canister inlet necessary empty secretion
canister, clean the oversuction
protection and check float ball
for flexibility.

18
11.0 Accessories, consumables and spare parts

REF
11.1 Accessories for A and C class
Grad. secretion canister, 1 l DDS, blue, PSU 313.0015.0
Grad. secretion canister, 1 l DDS, transparent, PSU 313.0017.0
Cover for Secretion canister lid, 1 l DDS, blue, with spare bacterial filter 313.0006.0
secretion canister
(incl. spare DDS filter) Separate rinsing canister set for ATMOS® A- and C- class 313.0008.0
incl. lid and support

Grad. Hose connector for hoses Ø 6 mm 000.0836.0


secretion canister 1 l
Hose rewind for suction hoses for ATMOS A- and C- class
®
313.0007.0
Power cable, 3-wire Schuko connector, 2 m 008.0866.0
Carrying bag, black 313.0011.0
Rewind system Device support for ATMOS® A- and C- class 313.0012.0
for suction hoses
Trolley on 4 castors, for A- and C- class 320.0070.2
Support for Receptal external canister 1 l and 1.5 l
®
313.0009.0
Support for Medi-Vac® external canister 1 l 313.0010.0
Separate
rinsing canister set
Support for Serres external canister 1 l
®
313.0413.0
11.2 Consumables
Bacterial filter for ATMOS® DDS secretion canister, 10 pcs. 340.0054.0
Set of consumables for ATMOS A- and C-class DDS
®
313.0160.0
Device support
General accessories
Receptal® external canister 1.5 l 310.0221.0
Serres external canister 1 l
®
312.0465.0
Medi-Vac® canister 1 l 312.0473.0
Basket for catheters, L = 340 mm 444.0140.0
Basket for catheters
DDS bacterial filter /
Basket with standard rail holder 320.0075.0
oversuction stop
Suction hoses / fingertip
Plak-VacTM tooth brush with suction mechanism 000.0821.0
Suction hose, silicone, Ø 6 mm, minimum purchase 5 m 006.0009.0
Suction hose, silicone, Ø 6 mm, L = 1.30 m, 1 pcs. 000.0013.0
Hose connection, Suction hose, PVC, disposable, Ø 6 mm, L = 1.30 m, 10 pcs. 006.0057.0
(fingertip)
Suction hose, PVC, disposable, Ø 6 mm, L = 2.10 m, 50 pcs. 006.0059.0
Trolley on
4 castors
Fingertip, sterile, not autoclavable, 000.0347.0
minimum purchase 10 pcs.
Suction bags
Receptal® suction bag 1.5 l, not autoclavable, 50 pcs. 310.0222.2
Medi-Vac suction bag 1 l, not autoclavable, 50 pcs.
®
312.0474.0
Serres suction bag, 1 l, not autoclavable, 36 pcs.
®
312.0466.0

Suction catheter Suction catheters


Suction catheter, size: CH 12, L = 50 cm, 100 pcs. 000.0294.0
Ø 4 mm, white, straight, central opening, 2 small lateral openings, suction
connection Ø 6 mm, #e, not autoclavable
Suction catheter, size: CH 14, L = 50 cm, 100 pcs. 000.0295.0
Ø 4.7 mm, green, straight, central opening, 2 small lateral openings, suction
connection Ø 6 mm, sterile, not autoclavable
Suction catheter, size: CH 16, L = 50 cm, 100 pcs. 000.0296.0
Ø 5.3 mm, green, straight, central opening, 2 small lateral openings, suction
Plak-VacTM toothbrush connection Ø 6 mm, sterile, not autoclavable

19
11.0 Accessories, consumables and spare parts
REF
11.3 Spare parts
Hider (Valid for ATMOS® C 161 / C 261 Aspirator) 999.1996.0
Self-adhesive elastic buffer 5J-5017 000.0018.0
Plug GPN 300 000.0824.0
Ball for overflow protection 000.0839.0

20
12.0 Technical specifications
ATMOS® A / C 161 Aspirator ATMOS® A / C 261 Aspirator
Air flow rate of pump 16 ± 2 l/min 26 ± 2 l/min
Max. vacuum -80 kPa* ± 2 kPa -80 kPa* ± 2 kPa
Vacuum readout (ATMOS C 161 / C 261 Aspirator) -1...0 bar (± 25 mbar) (mmHg; kPa)*
Additional air regulation (ATMOS C 161 / C 261 Aspirator) mechanical regulating valve
Additional air regulation (ATMOS A161 / A 261 Aspirator) Three-steps-adjustment
low= -25 kPa*, medium= -55 kPa*, high= -75 kPa*.
* depends on daily atmospheric pressure and Ambient conditions
Collection canister 1 l DDS secretion canister or 1.5 l Receptal® canister system or
1 l Medi-Vac® canister system or 1 l Serres® canister system
Suction hose ø 6 mm, 1.30 m length
Voltage 230 V~ (+/-10%) 50/60 Hz
Current input (max.) ca. 0.85 A (230 V~) ca. 0.46 A (230 V~)
Power consumption ca. 170 VA (230 V~) ca. 105 VA (230 V~)
Power cable 2m
Operating time Interrupted use over approx. 45 min at 230 V~, 50 Hz, 20°C
cooling period approx. 60 min., depending on ambient temperature
(Interrupted use over minimum 5 min. at 10 % higher rated voltage,
60 Hz, 35° C ambient temperature, 20 min. break)
Fuse T 1.25 A/H (230 V~) T 1,25 A/H (100-230 V~)
Protective earth conductor resistance —
Earth leakage current —
Enclosure leakage current N.C. < 0.1 mA
Patient leakage current —
Heat emission 100 J/s
Noise level (ATMOS C161 / C 261 Aspirator) 50.0 dB (A) @ 1m (nach ISO 7779)
Noise level (ATMOS A161 / A 261 Aspirator) 53.0 dB (A) @ 1m (nach ISO 7779)
Ambient conditions
-30...+50°C
Transport/storage 5...90 % humidity,
non-condensing air pressure 700...1060 hPa
+10...+35°C
Operation 20...80 % humidity,
non-condensing air pressure 700...1060 hPa
Dimensions HxBxT 250 x 255 x 180 mm
Weight 3.5 kg
Period tests Recommended: Testing every 24 months.
Protection class (EN 60601-1) II
Applied Part type BF

Degree of protection IP 21
Classification acc. to Annex IXEEC directions 93/42/EEC IIa
CE marking CE 0124
UMDNS-Code 10-219 (tracheal suction device)

* 1 bar ≈ 750,06 mm Hg ≈ 1000 hPa / depends on daily atmospheric pressure


Issue of Technical Specifications: 09.01.2017

21
13.0 Checking / Reprocessing / Disposal

13.1 Checking ATMOS suction devices


The ATMOS® suction devices are maintenance-free in the case they are used according to the operating instructions.
Please comply with the country-specific guidelines regarding regular testing especially for the electrical safety.
ATMOS recommends a test every 24 months

Regular, thoroughly cleaning and disinfection of the hoses and the application parts respectively the operation in line with the
operating instructions are assumed.

(Valid for ATMOS® C 161 / C 261 Aspirator)


A regular check of the condensate-controller on the rear side is necessary. For visual inspection please remove the cap. The
device is oversucked if humidity or contamination is visible in the condensate collector.

13.2 Reprocessing (in perfect technical and hygienic condition)


If there is a change of patient or ownership then the device must be reprocessed acc. to Medical Devices Operator
Ordinance, Medical Devices Act and BVMed guidelines.
An oversucked (contaminated) device must be repaired by the manufacturer, by a certified ATMOS partner or an ATMOS
authorized, specialized dealer.

ATMOS MedizinTechnik GmbH & Co. KG offers their partners and customers a trouble-free and quick reprocessing and
checking / period tests for ATMOS suction devices.

13.3 Disposal
When the device is operated according to the operating instructions it has an expected service life
of 5 years. A regular thorough cleaning and disinfection, respectively the operation in line with the
operating instructions are assumed.

● The ATMOS® A / C 161 / 261 Aspirator is not comprised of any hazardous materials.
● The materials of the housing can be recycled completely.
● Prior to disposal, device and accessories must be decontaminated.
● The materials are to be separated carefully.
● Pay attention to country-specific regulations for disposal (e. g. waste incineration).

Disposal within the EC

The suction device described above is a high-quality medical product with a long service life. After its life cycle it must
be disposed of professional. According to the EC directives (WEEE and RoHS) the device may not be disposed of in
domestic waste. Please observe existing national laws and rules for disposal of old devices.

Disposal within the Federal Republic of Germany

In the Federal Republic of Germany the law for electrical devices (ElektroG) rules the disposal of electrical devices.
Since this type of product is mainly used at home for secretion suction in the respiratory tract (after laryngectomy), it
must be assumed that those suction devices could be contaminated. Therefore, this type of device is excluded from
the law for electrical devices. In order to guarantee a proper disposal of your old device, please either pass on your old
device to your specialised dealer or send it directly to ATMOS MedizinTechnik for a professional disposal.

Prior to disposal respectively before transport all secretion canisters and hoses must be thoroughly cleaned,
disinfected. The device surface must be disinfected.

22
14.0 Notes on EMC

■ Medical electrical equipment is subject to special precautions with regard to EMC and must be installed acc.
i to 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.

14.1 Guidelines and Manufacturer´s Declaration - Emissions


The ATMOS® A / C 161 / 261 Aspirator is intended for use in the electromagnetic environment specified below. The
customer or user of the ATMOS® A / C 161 / 261 Aspirator should ensure that it is used in such an environment.

Emissions Test Compliance Electromagnetic Environment - Guidance


Harmonics IEC 61000-3-2 Class A The ATMOS® A / C 161 / 261 Aspirator is suitable
for use in all establishments, including domestic,
and those directly connected to the public low-vol-
tage power supply network that supplies buildings
used for domestic purposes.
Flicker Inapplicable
IEC 61000-3-3

23
14.0 Notes on EMC

The device 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.

14.2 Guidelines and Manufacturer´s Declaration - Immunity for


ATMOS® A / C 161 / 261 Aspirator
The ATMOS® A / C 161 / 261 Aspirator is intended for use in the electromagnetic environment specified below. The
customer or user of the ATMOS® A / C 161 / 261 Aspirator should ensure that it is used in such an environment..

IEC 60601- Electromagnetic Environ-


Immunity Test Compliance Level
Test Level ment - Guidance
ESD ± 6 kV Contact ± 6 kV Contact Floors should be wood, concrete,
IEC 61000-4-2 or ceramics tile. If floors are syn-
± 8 kV Air ± 8 kV Air thetic, the relative humidity should
be at least 30 %.
EFT ± 2 kV Mains ± 2 kV Mains Mains power quality should be that
IEC 61000-4-4 of a typical commercial or hospital
± 1 kV I/Os environment.
Surges ± 1 kV ± 1 kV Mains power quality should be that
IEC 61000-4-5 symmetric symmetric of a typical commercial or hospital
environment.
± 2 kV ± 2 kV
symmetric symmetric
Voltage Dips / Dropout < 5 % UT < 5 % UT Mains power quality should be that
IEC 61000-4-11 (> 95 % Dip of the UT) (> 95 % Dip of the UT) of a typical commercial or hospital
for 0.5 Cycle for 0.5 Cycle environment. If the user of the
ATMOS® A / C 161 / 261 Aspira-
40 % UT 40 % UT tor demands continued function
(60 % Dip of the UT) (60 % Dip of the UT) even in case of interruptions of the
for 5 Cycles for 5 Cycles energy supply, it is recommended
to supply the ATMOS® A / C 161 /
70 % UT 70 % UT 261 Aspirator from an uninterrupti-
(30 % Dip of the UT) (30 % Dip of the UT) ble current supply or a battery..
for 25 Cycles for 25 Cycles

< 5 % UT < 5 % UT
(>95 % Dip of the UT) (>95 % Dip of the UT)
for 5 s for 5 s

Power Frequency 50/60 3 A/m Inapplicable Power frequency magnetic fields


Hz should be that of a typical com-
Magnetic field mercial or hospital environment.
IEC 61000-4-8
NOTE UT is the mains alternating current prior to application of the test levels.

24
14.0 Notes on EMC
14.3 Guidelines and Manufacturer´s Declaration - Immunity
The ATMOS® A / C 161 / 261 Aspirator is intended for use in the electromagnetic environment specified below. The
customer or user of the ATMOS® C 161 should ensure that it is used in such an environment.

IEC 60601- Electromagnetic Environment


Immunity Test Compliance Level
Test Level - Guidance
Portable and mobile communications
Conducted RF 3 Veff
10 V equipment should be separated from the
IEC 61000-4-6 150 kHz bis 80 MHz
RS 221 incl. the cables by no less than the
Radiated RF 3 V/m distances calculated/listed below.
IEC 61000-4-3 80 MHz bis 2,5 GHz 10 V/m
Recommended distances:

d = 0,35 √ P

d = 0,35 √ P
80 MHz to 800 MHz

d = 0,70 √ P
800 MHz to 2,5 GHz

where „P“ is the max. power in watts (W)


and D is the recommended separation
distance in meters (m).

Field strengths from fixed transmitters, as


determined by an electromagnetic site (a)
survey, should be less than the compli-
ance level (b).
Interference may occur in the vicinity of
equipment containing following symbol

NOTE 1 With 80 MHz and 800 MHz the higher frequency range applies.

NOTE 2 These guidelines don´t like to be applicable in any case. The propagation of electromagnetic sizes is
influenced by absorptions and reflections 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 predestined exactly.
To determine the electromagnetic environment in regard to stationary transmitters, a study of the location is to
be considered. If the measured field strength at the location where the ATMOS A / C 161 / 261 Aspirator is
used exceeds the above compliance level, the ATMOS® A / C 161 / 261 Aspirator is to be observed to verify
the intended use.
If abnormal performance characteristics are noted, additional measures might be necessary, e. g. a changed
arrangement or another location for the device.

b Within the frequency range of 150 kHz to 80 MHz the field strength is to be below 3 V/m.

25
14.0 Notes on EMC
14.4 Recommended separations between portable and mobile RF Communications
equipment and the ATMOS® A / C 161 / 261 Aspirator

Recommended separations between portable and mobile RF Communications


equipment and the ENT-camera ATMOS® A / C 161 / 261 Aspirator
The ATMOS® A / C 161 / 261 Aspirator is intended for use in electromagnetic environment in which
radiated disturbances are controlled. The customer or user of the ATMOS® C 161 Aspirator can help
prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF
Communications equipment and the ATMOS® A / C 161 / 261 Aspirator as recommended below, according to the
maximum output power of the communications equipment.
Separation distance, depending on transmit-frequency m
Nominal output of the 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
transmitter
d = [0,35] √ P d = [0,35] √ P d = [0,35] √ P
W
0,01 0,035 0,025 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 isn´t indicated in the above table, the recommended sepa-
ration 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 don´t like to be applicable in any case. The propagation of electromagnetic sizes is
influenced by absorptions and reflections of buildings, objects and people.

26
For your notes

27
ATMOS MedizinTechnik GmbH & Co. KG
Ludwig-Kegel-Str. 16
79853 Lenzkirch / Germany
Phone: +49 7653 689-0
atmos@atmosmed.de

www.atmosmed.com

You might also like