Professional Documents
Culture Documents
ATMOS Aspirator
ATMOS Aspirator
ATMOS Aspirator
ATMOS® A 161 /
A 261 / C 161 /
C 261 Aspirator
Operating instructions
GA1GB.310110.0
2017-03 Index: 35 0124
Table of contents
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.
• 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.
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
!
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:
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.
1 2 3 5 6
3.3 Starting up
Fig 2b. ● The ATMOS® A / C 161 / 261 Aspirator is delivered
ready for use.
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!
!
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.
!
AUXILIARY AIR VENT OPEN =
suction procedure is interrupted (e.g. when leading in the catheter)
● 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
Fig 7.
DDS canister
Fig 9.
Fig 10.
9
6.0 Operation Receptal®
Fig. 11.
Receptal® canister
Fig 12.
11 12 13
11 Vacuum channel
12 Vacuum hose
13 Connection for vacuum hose
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.
11 12 13
i Check again for density, otherwise no vacuum
can be built up.
11 Vacuum channel
12 Vacuum hose
13 Connection for vacuum hose
Fig. 16.
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
every 2 weeks
every 4 weeks
contamination
13
8.0 Cleaning
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
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:
exchange
exchange
exchange
exchange
exchange
exchange
exchange
exchange
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.
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:
● 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.
– 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
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)
21
13.0 Checking / Reprocessing / Disposal
Regular, thoroughly cleaning and disinfection of the hoses and the application parts respectively the operation in line with the
operating instructions are assumed.
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).
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.
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.
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.
< 5 % UT < 5 % UT
(>95 % Dip of the UT) (>95 % Dip of the UT)
for 5 s for 5 s
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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.
d = 0,35 √ P
d = 0,35 √ P
80 MHz to 800 MHz
d = 0,70 √ P
800 MHz to 2,5 GHz
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
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