Atmos C 11 User manual

Operating Instructions
ATMOS C 11
Systema
English
GA1GB.110300.0
2023-07 Index 23

2
Table of contents
1 Introduction.......................................................................................................3
1.1 Notes on operating instructions ..............................................................................3
1.2 Explanation of pictures and symbols ......................................................................4
1.3 Intended purpose ......................................................................................................6
1.4 Function.......................................................................................................................7
1.5 Scope of delivery........................................................................................................8
1.6 Transport and storage...............................................................................................8
2 Notes for your safety........................................................................................9
2.1 General safety instructions.......................................................................................9
2.2 Danger for users, patients, and third parties .........................................................9
2.3 Avoiding damage to the device ............................................................................. 11
3 Setting up and starting up .............................................................................12
3.1 Required connections (power supply).................................................................. 12
3.2 Connection to electrical power line ...................................................................... 12
3.3 Overview of complete equipment ........................................................................ 13
3.4 Rear view.................................................................................................................. 14
4 Operation.........................................................................................................15
4.1 Suction system ........................................................................................................ 15
4.2 Canister systems ..................................................................................................... 16
4.3 Disposable canister system ................................................................................... 19
4.4 Compressed-air module......................................................................................... 21
4.5 ATMOS LS 21 LED – quick start.............................................................................. 23
4.6 ATMOS HL 21 LED – quick start ............................................................................. 25
4.7 LED cold light module............................................................................................. 26
4.8 Endoscope management ....................................................................................... 27
4.9 Emptying the instrument disposal........................................................................ 28
5 Reprocessing....................................................................................................29
5.1 General information on cleaning and disinfection ............................................. 29
5.2 Recommended instrument disinfectants ............................................................ 31
5.3 Recommended surface disinfectants................................................................... 33
5.4 Recommended endoscope disinfectants............................................................. 34
6 Maintenance and service...............................................................................37
6.1 Sending in the device.............................................................................................. 37
7 Troubleshooting ..............................................................................................38
8 Accessories and consumables.......................................................................40
8.1 Using the accessories ............................................................................................. 40
9 Disposal............................................................................................................44
10 Technical data .................................................................................................45
11 Notes on EMC ..................................................................................................47
12 Notes ................................................................................................................49

3Introduction
1 Introduction
1.1 Notes on operating instructions
These operating instructions contain important information on how to oper-
ate your product safely, correctly, and eectively.
These operating instructions are designed for training and instructing operat-
ing personnel in the use of the system, and they are also intended for use as
a reference manual. Reproduction, even partial, is only permitted with written
permission from ATMOS.
These operating instructions must always be kept available near the
product.
Care, periodic tests, regular cleaning, and proper application are essential.
They ensure the operational safety and usability of the product.
Maintenance, repairs, and periodic tests may only be carried out by persons
who have the appropriate technical knowledge and are familiar with the
product. To carry out these measures, the person must have the necessary
test devices and original spare parts.
The unit ATMOS C 11 Systema bears CE marking CE 0124 according to the EU
Council Directive 93/42/EEC concerning medical devices and meets the basic
requirements of Annex I to this directive.
The unit ATMOS C 11 Systema complies with all applicable requirements of the
Directive 2011/65/EU restricting the use of certain hazardous substances in
electrical and electronic equipment (“RoHS”).
The declarations of conformity and our general standard terms and conditions
can be obtained on our website at www.atmosmed.com.
The quality management system applied at ATMOS has been certied accord-
ing to international standard EN ISO 13485.
Prior to start-up, please peruse chapter “2 Notes for your safety” on page 9
in order to be prepared for any possible dangerous situations.
These operating instructions are valid for the following devices:
ATMOS C 11 Systema (sitting) REF 541.0000.0
ATMOS C 11 Systema (standing) REF 542.0000.0
ATMOS C 11 China REF 541.0100.0

4Introduction
1.2 Explanation of pictures and symbols
In the operating instructions
DANGER
Warning of a danger that will result in immediate fatal or serious injury.
Observe the necessary measures.
WARNING
Warning of a danger that can cause fatal or serious injury. Observe the
necessary measures.
CAUTION
Warning of a danger that can cause minor injury. Observe the neces-
sary measures.
NOTICE
Notice of a danger that can damage the product or other objects.
Observe the necessary measures.
Warning of a danger that can cause injury or death.
Notice of potential material damage.
Useful information on the handling of the device.
1. Action. Proceed step by step.
»Result of an action.
Move, plug in this direction.
click Engage, check correct t.
On device, type plate, and packaging
Follow operating instructions (blue)
Consult operating instructions
Warning; pay special attention
!
Warning; pay special attention (yellow)
Warning; hot surface
This device complies with the relevant requirements of EU regulations.
This device complies with the relevant requirements of the Eurasian
Economic Union.

5Introduction
Manufacturer
Date of manufacture
DE
Date of manufacture
Country of manufacture: Germany
REF Reference number
UDI Unique Device Identier of a medical device
MD Medical device
SN Serial number
EAN European Article Number
LOT Batch code
IPX0 Specication of the degree of protection against the ingress of solids and
moisture
Type BF applied part
Professional disposal
Do not reuse
Compressed-air system
Suction system
Mirror quick heater
Potential equalization
Protection class I device
Fuse
Alternating current
This side up

6Introduction
Fragile, handle with care
Keep dry
Keep away from sunlight
Temperature limit
Humidity limitation
700
1060
Atmospheric pressure limitation
UDI application identier
REF 541.0000.0 REF 542.0000.0
(01) 04250365175417 (01) 04250365175677
(11) 220404 (11) 220404
(21) 00000000 (21) 12345678
REF 541.0100.0
(01) 04250365193442
(11) 220411
(21) 12345678
1.3 Intended purpose
Product name: ATMOS C 11 Systema
Main functions: • Medical suction
• Ear irrigation
• Medication spraying or spraying
• Electric power supply for visualization, illumination and
illumination accessories
• Instrument storage and deposit
• Instrument heater

7Introduction
Intended use: Standard ENT examination and / or therapy
Intended users /
user prole:
Doctors and medical specialists
Intended patient
target groups:
All patients without any restrictions
Medical conditions to
be diagnosed, treated
or monitored:
Diagnostic examination of anatomy of all kinds
Organ(s) applied to: Ear, Nose, Throat
Duration of applica-
tion:
< 60 min.
Use environment: Outpatient medical facilities, e.g. ENT practices, hospital
outpatient departments, medical care centers
Patient selection
criteria:
None
Indications: Standard ENT examination and / or therapy
Medical contra-
indications:
Ear irrigation:
Should not be applied to an infected auditory canal or a
perforated eardrum
Other contra-
indications:
Pharyngeal suction:
Not indicated for pharyngeal suction of vomit
Warnings: None
The product is: active
Sterility / specic
microbial state:
Not sterile
Single-use device /
reprocessing:
Not a single use product. Reprocessing according to instruc-
tions for use
1.4 Function
• Suction system module
• Compressed-air module
• Ear irrigation by means of compressed air
• LED light handle ATMOS LS 21 LED
• LED headlight ATMOS HL 21 LED
• LED cold light source
• Instrument deposit
• Endoscope management
• Mirror quick heater

8Introduction
1.5 Scope of delivery
The ATMOS C 11 Systema was subjected to an extensive functional test and was careful-
ly packed prior to dispatch.
Nevertheless, please compare the contents of the shipment on completeness immedi-
ately upon receipt (see delivery note).
Scope of delivery ATMOS C 11 Systema (sitting):
Basic module with two large drawers, one small drawer, service compartment for
secretion canister, safe storage of three clean and three used endoscopes at a time, two
connections for LED light handle ATMOS LS 21 LED and LED headlight ATMOS HL 21 LED,
holder for LED light handle with automatic start-up function by means of light barriers,
three holders for medication sprayers, two holders for irrigation bottles, suction mod-
ule, suction hose, power cable, operating instructions.
Scope of delivery ATMOS C 11 Systema (standing):
Basic module with three large drawers, one small drawer, service compartment for
secretion canister, safe storage of three clean and three used endoscopes at a time, two
connections for LED light handle ATMOS LS 21 LED and LED headlight ATMOS HL 21 LED,
holder for LED light handle with automatic start-up function by means of light barriers,
three holders for medication sprayers, two holders for irrigation bottles, suction mod-
ule, suction hose, power cable, operating instructions.
1.6 Transport and storage
Only transport the product in a shipping carton that is padded and oers sucient
protection.
If damage occurs during transport:
1. Document and report the transport damage.
2. Send the device to ATMOS.
Ambient conditions for transport and storage:
• Temperature: −20...+50°C
• Humidity without condensation: 30...95%
• Air pressure: 500...1060hPa

9Notes for your safety
2 Notes for your safety
Please read and pay attention to the safety instructions prior to using the product.
2.1 General safety instructions
Only use accessories and options that are specically suited for combination with the
product and that meet the performance and safety requirements.
If you wish to connect more than one device or applied part, you must always observe
their safety instructions.
Report all serious incidents that have occurred in connection with this product to the
manufacturer and your national competent authority.
Please note that the drawers may only be lled with a maximum load of 4.5 kg.
Please also note that only one drawer may be pulled out at a time.
Make sure that the rollers are always locked when using the treatment unit.
The device may not be operated in the vicinity of an MRI (magnetic resonance imaging)
scanner.
2.2 Danger for users, patients, and third parties
Choking hazard for children due to accessories!
Children can strangle themselves or choke on small parts.
• Keep children away from hoses and connection cables.
• Keep children away from swallowable small parts. Examples of swallowable small
parts are the ngertip and sealing ring.
Explosion and re hazard!
Burns and injuries are possible.
• Never operate the product in potentially explosive areas or in areas that are oxygen-
ated.
• Use only original accessories and original spare parts from ATMOS.
Avoid improper use or incorrect diagnosis.
Your patient can be severely injured.
• The product is only permitted for use by trained, specialist personnel under supervi-
sion.
• The product may only be applied by medically trained sta.
• A diagnosis may only be made by persons with the appropriate medical training.
Tripping hazard due to cables.
Injuries and fractures are possible.
• Lay connecting cables properly.

10 Notes for your safety
Electric shock due to unsuitable power connection, incorrect handling of the
product, or damaged product components.
Burns, cardiac arrhythmias, and even fatal injury are possible.
• Do not operate the device if it has been dropped. In this case, clean and disinfect the
device and send it to ATMOS for repair.
• Prior to each use, check for damage to the device and the power cable. Do not oper-
ate the device if you notice any damage. In this case, clean and disinfect the device
and send it to ATMOS for repair.
• Disconnect the device from the power supply prior to cleaning or disinfection.
• Disconnect the device from the power supply prior to servicing, repairing, or opening
it.
• You can only disconnect the device from the power supply by pulling out the power
plug.
• Position the device in such a way that you can easily disconnect it from the power
supply at any time.
• Only connect the device to a power supply with a protective earth conductor.
• Never touch the plug or power cable with wet hands.
• Only use the power supply unit and power cable in dry surroundings. The surround-
ings must be non-conductive.
• Ensure that no liquid penetrates the device. If liquid has entered the device, op-
eration of the device must cease immediately. In this case, clean and disinfect the
device and send it to ATMOS for repair.
• Only use the power supply unit and power cable according to the operating instruc-
tions.
• Only use proper power connections and extension cords.
• Never touch the device’s interfaces and the patient at the same time!
• Use only original accessories and original spare parts from ATMOS.
• Observe the specications regarding periodic tests in chapter “6 Maintenance and
service” on page 37.
• Assembly, new settings, modications, extensions, and repairs may only be carried
out by authorized persons.
• Do not modify the device without the manufacturer’s permission.
Keep the device fully functional at all times.
Malfunctions could cause injury to you and your patients.
• Please observe the notes on the electromagnetic compatibility (EMC) of the device in
chapter “11 Notes on EMC” on page 47.
• Perform a function check prior to each use.
• Observe the specications regarding periodic tests in chapter “6 Maintenance and
service” on page 37.
• Use only original accessories and original spare parts from ATMOS.
• Assembly, new settings, modications, extensions, and repairs may only be carried
out by persons who are authorized by ATMOS.
Risk of infection due to pathogens on the product!
Deadly diseases can be transmitted.
• Always wear disposable gloves if there is a risk of you coming into contact with
secretions.
• Always wear disposable gloves when using the product.

11Notes for your safety
• Never use components marked with more than once. These components are
intended for single use only.
• Only use sterile packaged parts if the packaging is undamaged.
• Never operate the device without a bacterial lter.
• A suction catheter, suction attachment, or medical suction instrument must always
be connected to the suction hose. The suction hose must never come into direct
contact with the suction area.
• Clean and disinfect the product after every use.
• Clean and disinfect the product according to the operating instructions.
• The product must not be used following oversuction.
2.3 Avoiding damage to the device
Storage and operation in an unsuitable environment.
The product may become damaged.
• Please observe the ambient conditions for transport, storage, and operation.

12 Setting up and starting up
3 Setting up and starting up
3.1 Required connections (power supply)
Unit / Device Maximum required connections
ATMOS C 11 Systema 1x earthing contact socket outlet
Optional:
Monitor 1x earthing contact socket outlet
Microscope ATMOS i View 1x earthing contact socket outlet
Patient chair 1x earthing contact socket outlet
3.2 Connection to electrical power line
• According to the directions of VDE 0107 and VDE 0100, medically used rooms have
to be equipped with a leakage current protective circuit (FI protective circuit) with
a nominal leakage current of < 0.03 A. The installation must correspond with VDE
0107.
• The power cable of the ATMOS C 11 Systema is connected to an earthing contact
socket near the device (max. 5m; see gure). This may only be carried out by author-
ized qualied personnel.
• The maximum power consumption is 270 W.
• Please provide for additional sockets for the connection of further electrical devices
(installation of an electrically operated ATMOS patient chair, etc.).
• To switch on the unit, move the on/o switch to the “on” position.
• To switch o the unit, move the on/o switch to the “o” position. In this position,
the unit is disconnected from the power supply.

13Setting up and starting up
3.3 Overview of complete equipment
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
19
18
1Headlight holder with automatic switching (optional)
2Endoscope management for rigid or exible, clean endoscopes (optional)
3Mirror quick heater (optional)
4Endoscope quiver for used endoscopes (optional)
5LED light handle (optional)
6Brightness controller
7Light guide cable
81-channel cold light source (optional)
9Instrument disposal for used instruments (optional)
10 On/o switch
11 Service compartment
12 Compartment for secretion canister
13 Drawers
14 Automatic suction equipment
15 Compressed air (optional)
16 Medication sprayer (optional)
17 Ear irrigation module compressed air (optional)
18 Instrument deposit (optional)
19 Storage shelf (optional)

14 Setting up and starting up
3.4 Rear view
1
1Power connection

15Operation
4 Operation
4.1 Suction system
CAUTION
Prior to application, please check suction performance and leak tightness of the suction
system.
To do this, please remove the hose from the support and close the hose end with your
nger. Check whether vacuum builds up. In case of any leakage (no vacuum build-up,
hissing sound), please contact the service technician (see chapter “4.2.10 DDS change-
over docking station” on page 19 and “6 Maintenance and service” on page 37).
Make sure that you always insert the suction hose into the left support marked with the
symbol (see gure below).
NOTICE
Never operate the suction system without a bacterial lter. Always use the splash pro-
tection; this will prolong the service life of the bacterial lter. ATMOS does not assume
any liability for malfunctions caused by operating the device without a bacterial lter.
NOTICE
Exchange the bacterial lter regularly. For more information, see chapter “4.2.2 Insert-
ing/removing the DDS bacterial lter / oversuction stop” on page 16.
The hose attachment must be exchanged after each patient.
Please note that the hose attachments can be cleaned and disinfected mechanically up
to 70°C.
4.1.1 Activation
1. Take the handle from its holder. The suction system is automatically activated via the
installed light barrier.
2. The bacterial lter / oversuction stop of the DDS reusable system and the overow
protection systems in the secretion canisters of the disposable systems safely
prevent oversuction.
3. If the canisters are full, the overow protection systems separate the canisters from
the vacuum. This can be recognized by a decrease in suction capacity on the handle.
In this case, please insert a new suction bag in the disposable system or remove,
empty, clean, and disinfect the reusable canister system as described in chapter “5
Reprocessing” on page 29 and insert a new bacterial lter.

16 Operation
4.2 Canister systems
4.2.1 Reusable canister system
Assembly of secretion canister
DDS canister handle
340.0055.0
DDS canister lid with gaskets
340.0053.0
DDS bacterial lter
340.0054.0
DDS splash protection
340.0056.0
DDS secretion canister
1.5 l 340.0050.0 or
3.0 l 340.0051.0
DDS hose adapter set
340.0057.0
4.2.2 Inserting/removing the DDS bacterial lter / oversuction stop
Please wear gloves when inserting or
removing the DDS bacterial lter!

17Operation
4.2.3 Using the DDS splash protection
Please wear gloves when inserting or
removing the DDS splash protection!
4.2.4 Attaching/removing the DDS canister lid
1. Place the DDS secretion canister on a
rm surface and set the DDS canister
lid horizontally on top (the lid cannot
not be turned!).
2. Press it tightly with both hands as far
as it will go onto the canister.
3. With one hand on the canister handle,
lift the complete canister upwards.
With the other hand on the canister
bottom, guide the canister in order to
prevent it from tilting when lifting it
out.
4. Unhinge the snap-in hook of the can-
ister handle on the canister. Pull out
the snap-in hook with both hands and
remove the canister handle upwards.
Remove the bacterial lter/ oversuc-
tion stop from the canister handle.
5. Remove the canister lid from the
canister with both hands. Remove the
splash protection.
4.2.5 DDS canister handle



 Canister handle
 Snap-in hook
 Canister rim

18 Operation
4.2.6 Closing/opening the DDS canister handle
1. To close, secure the snap-in hooks
under the canister rim, and then press
the clips towards the middle of the
canister until they lock into place.
2. To open, pull the clips outwards and
unhinge the snap-in hooks under the
canister rim.
4.2.7 Removing/securing the DDS secretion canister
1. Open the storage compartment for
the secretion canister, remove the
DDS canister by lifting it vertically
upwards; to reinsert it, allow it to slide
vertically downwards into the securing
device.
4.2.8 Inserting the DDS hose adapter
1. Press the required DDS hose adapter
with 6mm or 10mm diameter into
the opening “PATIENT“ on the DDS
secretion canister lid, twisting slightly
to ensure a tight t.
2. Twist slightly in the same manner
when removing the adapter.
4.2.9 Connecting the hose
1. Please put the hose on the hose
adapter.

19Operation
4.2.10 DDS changeover docking station
1
Maximum load of the station: 15 kg!
• The DDS changeover docking station
for 2 canisters with changeover switch
and Direct Docking System may be
used with the ATMOS C 11 Systema.
• The changeover lever is used to
switch the vacuum to the canister to
which the lever points.
• To remove or insert a canister, switch
the changeover lever towards the
canister that is not being replaced.
4.2.11 Emptying the reusable canister system
NOTICE
The canister system must be cleaned and disinfected regularly. For more information,
see chapter “5 Reprocessing” on page 29.
NOTICE
Open the side drawer regularly to check the ll-level in the secretion canister.
Empty the secretion canister manually when it is about half full.
To do this, pull the secretion canister horizontally out of the support in the service
compartment and remove the suction hose.
4.3 Disposable canister system
4.3.1 Assembling the Receptal® canister system
Receptal® bag
Patient
Pump
1. Insert the Receptal® suction bag into
the Receptal® external canister.
2. Close the canister tightly on all sides.
3. Check again for leaks; otherwise, no
vacuum can be built up.
4. Plug in the vacuum hose of the pump
and attach the secretion hose to the
connection marked “PATIENT”.
Only suction bags with an integrated
bacterial lter may be used.

20 Operation
4.3.2 Assembling the Medi-Vac® canister system
Medi-Vac® bag
Patient
Pump
1. Insert the Medi-Vac® suction bag into
the Medi-Vac® external canister.
2. Close the canister tightly on all sides.
3. Check again for leaks; otherwise, no
vacuum can be built up.
4. Plug in the vacuum hose of the pump
and attach the secretion hose to the
connection marked “PATIENT”.
Only suction bags with an integrated
bacterial lter may be used.
4.3.3 Assembling the Serres® canister system
-0,2
+0,2
MedizinTechnik
Tolerierungsgrundsatz ISO 8015
Schutzvermerk DIN ISO 16016
Ers.d.:
Zeichnungs/
Artikel-Nr.
(part no.)
Benennung (designation)
Werksto (material)
Konstr.-Nr.:
Bl.
Blatt
(sheet)
Zust.
(index)
Änderung
(revision)
Datum
(date)
Name
(name)
Gepr.
Bearb.
Name
Datum
Maßstab (scale)
Serres-Behälter 1 L
05.312.01.04
1:10
PC
1/1
1
02.08.2011
Ers.f.:
ATMOS MedizinTechnik GmbH & Co. KG
Ludwig-Kegel-Str. 12,14-16, 18
79853 Lenzkirch / Germany
Tel: [phone]
Fax: [phone]
[email protected]
www.atmosmed.de
Erstellt
Baer
Alle Maße in mm
all dimensions in mm
Allgemeintoleranzen/
General tolerances
ISO 2768-mK
Serres® bag Patient
Pump
1. Insert the Serres® suction bag into the
Serres® external canister.
2. Close the canister tightly on all sides.
3. Check again for leaks; otherwise, no
vacuum can be built up.
4. Plug in the vacuum hose of the pump
and attach the secretion hose to the
connection marked “PATIENT”.
Only suction bags with an integrated
bacterial lter may be used.
4.3.4 Bemis® canister system
1. Insert the Bemis® suction bag into the
Bemis® external canister.
2. Close the canister tightly on all sides.
3. Check again for leaks; otherwise, no
vacuum can be built up.
4. Plug in the vacuum hose of the pump
and attach the secretion hose to the
connection marked “PATIENT”.
Only suction bags with an integrated
bacterial lter may be used.