Atmos C 051 Thorax User manual

Operatinginstructions
ATMOS ®C 051 Thorax
317.0000.B
2014-01 Index: 02

2
Further information, accessories, consumables and
spare parts are available from:
ATMOS
MedizinTechnik GmbH & Co. KG
Ludwig-Kegel-Straße 16
79853 Lenzkirch/Germany
Tel. + 49 7653 689-0
Fax: + 49 7653 689-190
+ 49 7653 689-292 (Service Center)
[email protected]
www.atmosmed.de

1.0 Introduction................................................................................................................................................. 4-7
1.1 Notes on operating instructions 4
1.2 Intended use 5
1.3 Contraindications 7
1.4 Function 7
1.5 Transport and storage 8
1.6 Explanation of symbols 9
2.0 Safety advice............................................................................................................................................ 10-13
2.1 Notice 10-11
2.2 Caution 12
2.3 Warning 13
3.0 Setting up and starting up .....................................................................................................................14-18
3.1 Scope of delivery 14
3.2 Device overview 15
3.3 Starting up 16
3.3.1 Charging the battery 16
3.3.2 Secretion canister 17
3.3.2.1 Secretion canister overview 17
3.3.2.2 Pop-Off valve 17
3.3.2.3 Connecting the secretion canister 17
3.3.2.4 Exchanging the secretion canister 18
3.3.3 Connecting the hose system 18
4.0 Operating.................................................................................................................................................. 19-26
4.1 Explanation of the display 19
4.2 Buttons and display symbols 20-21
4.3 Switch on 21
4.4 Leakage test 22
4.5 Function 23
4.5.1 Target vacuum 23
4.5.2 Suction 23
4.6 Release of key-lock 24
4.7 Therapy progress 25
4.7.1 Shorttime 25
4.7.2 Longtime 25-26
4.8 Switch off 26
4.9 User settings 27
4.9.1 System language 28
4.9.2 Vacuum unit 28
5.0 Alarms ........................................................................................................................................................... 29
6.0 Functions....................................................................................................................................................... 29
6.1 Hose rinsing 29
7.0 Accessories, consumables and spare parts .........................................................................................30-32
7.1 Attachment of the universal bracket 30
7.2 Attaching/removing the ATMOS C 051 Thorax to/from the universal bracket 31
7.3 Connecting of shoulder belt 31-32
8.0 Cleaning and care....................................................................................................................................33-35
8.1 General information on cleaning and disinfection 33
8.2 Cleaning of the device surface 34
8.3 Recommended disinfectants 34
8.4 Hygiene plan 35
9.0 Maintenance and Service....................................................................................................................... 36-37
9.1 Basic information 36
9.2 Repairs 36
9.3 Handling of rechargeable batteries 37
10.0 Eliminating errors ...................................................................................................................................... 38
11.0 Technical data ............................................................................................................................................ 39
12.0 Disposal ....................................................................................................................................................... 40
13.0 Notes on EMC......................................................................................................................................... 41-45
Declaration of confomity................................................................................................................................... 46
Table of contents

4
These operating instructions contain important notes on how to operate
the ATMOS®C051Thoraxsafely,correctlyandeectively.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. Full or
partial reproduction is subject to prior written approval from ATMOS.
These operating instructions must always be kept available near
the device.
Care and safety inspections in conjunction with professional execution
provide for operational safety and readiness for use of your ATMOS®C
051 Thorax and are therefore a must besides regular cleaning.
Repair work and safety inspections 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®C 051 Thorax will be
preserved.
The product ATMOS®C 051 Thorax bears CE marking CE 0124
according to the EC Directive of the council for medical products
93/42/EEC and meets the basic requirements of annex I of this
Directive.
ThequalitymanagementsystemappliedatATMOShasbeencertied
according to international standards EN ISO 9001 and 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.
1.0 Introduction
1.1 Notes on operating instructions

5
1.2 Intended use
1.2.1 Intended use ATMOS C 051 Thorax
Name: ATMOS®C 051 Thorax
Main functions: Digital device for mobile thoracic drainage
Med. indications/ application: 1. Recovery of the neutral vacuum in the intra pleural cavity after the
    occurrenceofapneumothoraxorapleuraleusionbydrainageofair
and secretion
2. Drainage of secretion and air after a surgical opening of the thorax
Specicationofthemainfunction: TheATMOSC051Thoraxdrainagesuctionunitisadigitaldevicefor
mobile thoracic drainage. The device is meant for the short-term (< 30 d)
application on humans. It is portable, grid independent and has an
electronic monitoring system with optical and visual status displays. The
device is applied unsterile. All thoracic catheter / drains can be applied,
which are intended for thoracic drainage in the intended use of the
manufacturer.
Patient group: Patients with thoracic injuries, which require drainage of the pleural cavity
to maintain lung function.
Additionally patients that require drainage of blood and secretion after a
surgical opening of the thorax.
Application organ: Thorax
Application time: Under normal circumstances it is suitable for continuous application over
a period of less than 30 days.
Application site: Application environment is a clinical area. The application of the device
may only be applied by healthcare professionals. The secretion canister
and the drainage hose are sterile and disposable, and can be applied in
the sterile OT area.

6
1.2.2 Intended use ATMOS®C 051 Thorax secretion canister
Name: Secretion canister 800ml for the connection to the
ATMOS®C 051 Thorax
Mainfunctions:  1.Forwardingofthecreatedvacuumintothedrainagetubeandnally
into the patient side drain
2. Collection of the exhausted secretion
Specicationofthemainfunction:Thevacuumgeneratedbythepumpevacuatesairandsecretionoutof
    thedrain.Thesecretioniscollectedinthesecretioncanisterwhoselling
    quantityis800ml.Abacteriallterpreventstheaccidentallyabsorption
of secretion into the pump head. A tubing system provides the
vacuum for the patient side drain. A direct connection to the patient
doesn’t exist. With the support of the test lead inside of the tubing
    system,whichisalsoprovidedwithalter,thevacuumonthedrainwill
be measured. Furthermore the test lead is also responsible for the
    ushingofthedraintubewithatmosphericair.
Patient group: Patients with thoracic injuries, who require drainage of the pleural cavity
to maintain lung function.
Additionally for patients who require drainage of blood and
secretion after a surgical opening of the thorax.
Application organ: Thorax
Application time: Under normal circumstances it is suitable for continuous application over
a period of less than 30 days.
Application site: Application environment is a clinical area. The application of the device
may only be applied by healthcare professionals. The secretion canister
and the drainage hose are sterile and disposable, and can be applied in
the sterile OT area.
Contraindications: Application of the canister with other low vacuum devices than
ATMOS®C 051 Thorax
The product is: Non active
Single use product / reprocessing: Single use product

7
1.4 Function
The ATMOS®C 051 Throax is an exceptionally handy, mobile, digital thoracic drainage suction device.
The device is operated via an electrical, maintenance-free membrane pump. During operation the pump creates
a vacuum within the suction hose and the secretion canister due to which secretion and air can be drained by
the hose system. The pump is controlled digitally and therefore secures that the chosen required vacuum value
isstable.Theairow,whichismeasuredinreal-time,isdisplayedinnumbers.Thesecretioniscollectedinthe
secretion canister. Its capacity is 800 ml. With the aid of the measuring and rinsing hose in the hose system the
vacuum at the end of the hose system is measured. Via the touch screen display the required vacuum can be set
manually. The suction power is regulated automatically.
The hose system is rinsed with air at regular intervals to prevent the collection of debris in the secretion hose.
Thismeasurealsopreventssecretionfromintrudingintothemeasuringandrinsinghoseorthatasyphoneect
is created.
The device is equipped with a rechargeable battery. A charging unit which is located within the suction device
guarantees for the secure charging of the battery. Therefore it is impossible to overcharge the battery.
Abacteriallterlocatedinthesecretioncanisterpreventstheintrusionofbacteriaandsecretionintotheaggre-
gation space. The device is equipped with a carrying strap. The strap allows for mobility and the fastening of the
device e.g. to the patient’s beds. As an accessory a universal connection can be ordered separately.
1.3 Contraindications
The following applications are contraindicated:
A separate application of the canister and the tubing system (this means without basic device) as gravity
drainage
Inambulancesunderemergencyconditionsandinthehomecareeldwhichisnotsupervisedbyhealthcare
professionals.
Suction of flammable, corrosive or explosive fluids / gases.

8
1.5 Transport and storage
Thetransportofthedevicemaybeeectedonlyinadispatchcartonupholsteredandoeringsucient
protection.
Please document and report damages in transit immediately.
For complaints or return deliveries, please use the enclosed form QD 434.
The form QD 434 can also be downloaded from: www.atmosmed.de
Theunitmustbeallowedtostandforuptosixhoursatroomtemperaturepriortostartingupfortherst
time following transport at temperatures below freezing. The unit may not be operated if it has not
acclimatised as this might damage its diaphragms.
Ambient conditions:
-Transport/Storage: -20...+50 °C;
5...95 % humidity non-condensing at air pressure700...1060 hPa
-Operation: +5...+35 °C;
20...80 % humidity non-condensing at air pressure700...1060 hPa
-Operation altitude: max. 3000 m

9
1.6 Explanation of symbols
!
■
●
→
click
click
Pictures contained in this manual
Warning,
special diligent notice!
Short cuts / symbols contained in this manual
Please press where
the dot indicates
Subnumeration
Numeration
General information
Follow the arrows whilst
proceeding, sequence
Replace
Check
Please read,
important information
Move, plug ... in this
direction
Engage,
checkcorrectt
Turn, shift ... in this
direction
Important information
Symbols of ATMOS C 051 Thorax & Accessories
Serial number
Order number
Manufacturing date
The CE sign shows that
this product meets
the appropriate requi-
rements of the EC
Directives.
Electricity fuse
Class II
REF
SN
Please observe ope-
rating instructions!
Application part
type BF
Multiple use of compo-
nents marked with
is not allowed.
This product is not
resterilisable.
In case of multiple use
this component looses
its characteristics and
there is a high risk of
infection.
22

10
2.0 Safety advice
2.1 Notice
NOTICE Damage to the device due to improperly installed protective contact
socket



The ATMOS® C 051 Thorax was produced in accordance with 60601-1/
EN 60601- it is a device of VDE-safety class II.
The device should only be connected to a properly installed protective
contact socket.
Priortorstusecomparethenormalvoltageofthedevice(seeindica-
tion label on the backside of the device) with the local mains voltage.
NOTICE ATMOS cannot guarantee perfect functioning neither will it be liable
for damage to people or property
if:
any non-original ATMOS parts are used,
the user instructions given in this manual are not followed exactly
or are disregarded,
inproper use
assembly, resetting, alterations, extensions and
repairs are not carried out by people authorised by ATMOS
NOTICE Electromagnetic compliance, damage to the device!
The ATMOS®C 051 Thorax should not be operated with devices not
complying with the requirements of standard EN 60601-1„Medical
Electrical Equipment“ and EN 60601-1-2 „Electromagnetic Compatibili-
ty“ (Medical Electrical Equipment)
NOTICE Damage to the device due to low temperatures
After transport in temperatures below freezing point the device must
be acclimatised for up to 6 hours. If the device is not acclimatised it
should not be operated as the membrane in the aggregate could get
damaged.
NOTICE Damage to the device due to tilting
The device and the canister must be used upright at all times.
If the device should tilt it must be placed upright again in order to
guarantee faultless operation.
If you are insecure whether the canister works properly we advise you
to replace the canister so as to ensure the patients’ safety.
NOTICE Damage to the device due to heat



The device and the canister should not be dried in a microwave oven.
The mains cable and the device must be kept away from hot surfaces.
The device may only be operated at room temperature and should not
be subjected to direct solar irradiation as this could lead to errors.

11
NOTICE Legal advice


The operating instructions are in conformity with the device
speccationsstandardsonsafetyatthetimeofprinting.
The circuits, processes, names, software
programmes 01.28 and devices are all covered by trade mark rights.
The law of the United States of America restricts the distribution of this
device to doctors or on behalf of doctors.
NOTICE Appropriate operation











The user should be able to reach the operating panel comfortably and
should have a good view on it at all times.
The canister may not be used without the device (gravity drainage)
The device may only be used by trained professionals.
The removal of the canister from the device during the therapy may
only be performed by trained professionals which act in conformity
with internal regulations.
The ATMOS® C 051 Thorax is a medical device which is subject to
special safety regulations. It must to be set up and put into
operation in accordance with the EMC regulations included in this ma-
nual. Portable and mobile RF communication devices (mobile phones)
mayaecttheperformanceofthedevice.
A second functioning device (consumables included) must be available
for every patient whose condition could become critical if the device in
use should get damaged.
The device may not be operated in MRI scanners (magnetic resonance
imaging)
Maximumowofthepump4.5l.
The device supports the therapy of the patient it is not a substitute for
the doctors‘ diagnosis.
The patient should be supervised constantly in accordance with the
internal rules of the hospital.
Prior to the removal of the hose connector the patient hose must be
pinchedo.
NOTICE Advice on disposal


Dispose of the packing material in a proper manner.
Attention must be paid to all hospital protocols regarding disposal and
infection control.
NOTICE Wrong evaluation


Prior to each application the device should be checked for leakages
(peruse chapter 4.4 – leakage test).
Leaking connections could lead to a wrong evaluation of the patients
status and could prolong the therapy. Thus do check all connections
for leakages to prevent the intrusion of additional air.

12
2.2 Caution
CAUTION Danger of injury


A misplaced drainage system and a misplaced patient hose could
hinder the drainage of air and liquids.
A complete blocking of the system during the drainage of liquids and
air could cause a rise in pressure and thus lead to a pressure
pneumothorax.
Place the drainage system below the thorax and check the patient
hose for bends and cloggings which could hinder the drainage of
liquids and air.
Immediate reaction is required in case of the "vacuum too low" alarm.
CAUTION Danger of injury




Iftheuidlevelinthecanisteristoohighitcouldcauseablockage
and thus a pressure pneumothorax.
Exchangethecanisterwhenthemaximumllinglevelisreachedto
secure the patients safety.
Defective components in the system have to be exchanged immediately.
The patient hose connection should be checked regularly for correct
functioning.
CAUTION Danger of injury



A bent hose could cause a pressure pneumothorax.
The bending of the patient hose leads to an interruption of the therapy
and incorrect measurements.
The hose should not be bent.
CAUTION Danger of injury


A vacuum over -70 mbar could cause pain and injury to the patient.
Only under medical indication a vacuum over 70 mbar may be adju-
sted.

13
2.3 Warning
WARNING Electric shock due to damaged connecting cables


Prior to use check the device and connecting cables for damages.
Damaged cables must be replaced!
WARNING Electric shock due to voltage!
Prior to disconnecting the battery from the mains pull the plug from
the electrical socket, after that you can disconnect the connecting
cable from the battery.
WARNING Electric shock due to voltage!




Disinfectant or secretion should not enter the device or battery.
If disinfectant/secretion has penetrated the device, then it must be
driedthoroughlyandsubsequentlyaneciencycontrolmustbe
conducted.It should be tested if the target vacuum can be reached in a
closedsystem,aswellasifthereisaow>4l/minafterashortwhile,
when the system is open. If not, the device must undergo a service
check before it resumes operation.
The mains adapter should not get wet.
Don´t take a shower / bath with the device.
WARNING Danger of explosion due to unobserved ambient conditions!
The ATMOS®C 051 Thorax may only be operated in rooms used for
medical purposes, but not in areas subject to explosion hazards
or in oxygen rich environments.
Explosionhazardousareasmayresultfromtheuseofammableanae-
stetics, skin cleansing agents and skin disinfectants.
Payattentiontotheambientconditionsspeciedinchapter11.0.
WARNING Risk of infection




This product is not re-sterilizable. Repeated reuse of components
which are marked with is forbidden. In case of repeated reuse
these components lose their function and there is a high infection
risk.
Repeated reuse of canister and hose systems can lead to infections.
Canister and hose system should only be used once on every patient.
For hygienic reasons we recommend an exchange of both canister and
hose system at the same time.
2

14
3.0 Setting up and starting up
3.1 Scope of delivery
The ATMOS C 051 Thorax was subjected to thorough testing prior to packaging and shipment.
On receipt of the goods please check the package for any possible damage and compare the contents for
completeness. ( see bill of delivery)
Description
Basic device
Recharger
Mains cable
Operating instructions
Carrying strap
Strap holder
Quick guide

15
Back side:
1
2
3
5
4
8
9
10
7
6 Touch screen
(touch-sensitive display)
 On/off sensor
 Charging socket
Secretion canister release
 Light sensor
 Clips for carrying strap
 Connection for secretion canister (right)
Measuring and rinsing hose (left)
Connection for clips
 Identification plate
 Canister guide
Connection for USB flash drives
3.2 Device overview
Front side:
11
11
6
7
8
317.0000.0
ATMOS C 051 Thorax

16
3.3 Starting up
Removethedevicefromthebox.Checkwhetherthevoltagevaluesontheidenticationplatematchwith
the available mains voltage.
Priortotherststartupperusethesafetynoticationsinchapter2.
Thebatterymustbefullychargedpriortotherstuse.Chargingtimeapprox.2.5hours.
Alwaysplacethedeviceonaat,savesurface.
Plug in the mains cable to recharge the battery.
After transport in temperatures below the freezing point the device must be acclimatised for up to 6 hours.
If the device is not acclimatised it may not be operated as the membrane in the aggregate could get
damaged.
Alwayshaveatleastonemoresecretioncanisterathandasthedevicecanonlybeoperatedwiththespecic
ATMOS secretion canister.
3.3.1 Charging the battery
Attention!
PriortotherststartupoftheATMOSC051Thoraxthebatterymustbefullycharged.
Only the enclosed battery recharger from ATMOS may be used. The device should be recharged in
a cool place without direct solar irradiation. At ambient temperatures above 25°C the charging time could
be prolonged drastically.
Defects which occur due to improper handling of the device are not covered by the guarantee.
Plug the recharger into the charging socket of the
ATMOS C 051 Thorax.
Connecttherechargertothecountry-specicmainscable.
Plug the mains plug into the socket. The ATMOS C 051 Thorax displays
the blinking symbol on the display.
When the battery is fully charged (the symbol does not
blink anymore) remove the plug from the socket.
After that remove the recharger plug from the charging socket of the
ATMOS C 051 Thorax.
Information: If the battery is low the drainage unit displays a warning
(peruse chapter 5.0 alarms for further information). If the battery is
too low for further operation of the device the ATMOS C 051 Throax
switchesoautomatically.
Advice on the handling of the battery can be found in chapter 9.3. The
battery of the ATMOS C 051 Thorax can also be charged when the
deviceisswitchedo.Thestateofchargecanbeseenonthedisplay.
Attention: The battery cannot be charged when the temperature of
the battery is above 35°C.
After transport in temperatures below the freezing point the device must be acclimatised for up to 6 hours.
Alwayshaveatleastonemoresecretioncanisterathandasthedevicecanonlybeoperatedwiththespecic
a cool place without direct solar irradiation. At ambient temperatures above 25°C the charging time could
!

17

 Pop-off valve (10 mbar high
pressure)
 Connection to the drainage
unit (protected by a hydropho-
bic bacteria filter)
Scales (in ml)
Connection to patient
(secretion channel)
Connection to patient
(measuring and rinsing system)
 Cover lid of the secretion
channel 
Cover lid for the connection to
the suction unit 
 Cover lid for the pop-off
valve 
 Canister guide




Important safety instructions
on the secretion canister
!
Always use the original ATMOS single use secretion canister
Vacuum connection system
The vacuum connection between device and canister is set up
immediately after connection!
For hygienic reasons we advise you to exchange hoses and canister
together.

3.3.2 Secretion canister
3.3.2.2 Pop-off valve
The pop-off valve is a protection against the occurrence of high pressure which could lead to a tension
pneumothorax.Thevalveopensatahighpressureof≥10mbarwithinthecanister.
3.3.2.3 Connecting the secretion canister
1. Cautiously withdraw the secretion canister from the wrapping.
Affix the canister´s guide to the device´s guide on the back side of the
drainage unit. (see device overview) Hold the canister slightly angled
to the device.
2. Push the secretion canister towards the ATMOS C 051 Thorax until
they connect palpably and audibly and the release button returns to its
initial position.
3. Perform a slight pull-check on the canister to make sure that it is
connected securely and tightly to the device.




3.3.2.1 Secretion canister overview

18
Measuring and rinsing hose
Hydrophobicbacteriallter
 Luer-Lock 4 mm
 Secretion hose
 Luer-Lock 6 mm
1. Remove the sterile hose system from the sterile wrapping.
2.ConnecttheLuer-Lockwiththebacteriallterto the lower canister
connection (on the secretion canister) by a cw rotation.
3. Connect the Luer-Lock connection with the larger diameter to the
upper connection of the canister (on the secretion canister) by
a cw rotation.
4. Perform a leakproof test (see chapter 4.4)
5. Use the sterile hose connector, supplied with the hose system,
to connect the hose system to any drainage catheter of your choice.
Alternately you can also use conventional sterile y-connectors or hose
connectors.
!


3.3.3 Connecting the hose system
1. Press the blue operating element (device overview) on top of the
device to release the canister.
2. Hold the secretion canister slightly angled and pull upwards to remove
it.
3. Place the secretion canister safely on an even surface.
4. Release the 2 Luer-Lock connections by a cc rotation to separate the
secretion canister from the hose system. Pay attention as secretion
could be found in the connection space.
5. Remove the yellow cover lid and cover the upper Luer-Lock
connection with it (secretion channel).
6. Remove the yellow cover lid and cover the connection to the
drainage unit with it.
7. Remove the black cover lid andcoverthepop-ovalvewithit.
The used secretion canister is now ready for disposal.
8. Follow the instructions in chapter 3.3.2.3 to connect a new secretion
canister.
3.3.2.4 Exchanging the secretion canister



1.
2.

19
Therapy progress
Setting button
Start / Stop
therapy
Setting button
System information
4.1 Explanation of the display
Target vacuum
Flow
Display of the actual
fistula
ATTENTION: This is the
current value. In the case of
a discontinous fistula, the
value can decline temporarily
to zero although the fistula
still exists.
Display of the preadjusted
target vacuum to which the pump
adjusts
Changeover to the
grafic diagram
Increases the
target vacuum
Decreases the
target vacuum
Each additional dark colored bubble represents an additional flow.
from 1 to 10: 0,25 l/min
from 11 to 12: 1,00 l/min
4.0 Operating
Key-lock activ
Flow displayed as bubbles
User settings

20
Figure Function
Decrease target vacuum / in the menu: decrease selected value
Increase target vacuum / in the menu: increase selected value
Gracdiagramofthetherapy
Open the user settings
Save entry
Conrmentry
Back / Exit menu
Warning / suppress the warning
Changeover to vacuum scaling
Changeover to time scaling
Changeovertoowscaling
Start therapy
Stop therapy
Hold/removegrac
Increase maximum of axis
Decrease maximum of axis
4.2 Buttons and display symbols
4.2.1 But tons