Atmos S 201 Thorax User manual

Operating instructions
ATMOS®S 201 Thorax
312.1000.B
2016-04 Index: 37
English
These operating instructions are valid from software-version 3.0.40.

2
Further information, accessories, consumables and
spare parts are available from:
ATMOS
MedizinTechnik GmbH & Co. KG
Ludwig-Kegel-Straße 16
79853 Lenzkirch
Deutschland
Phone: + 49 7653 689-0
Fax: + 49 7653 689-190
+ 49 7653 689-292 (Service Center)
[email protected]
www.atmosmed.de
Table of contents
1.0 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.1 Notes on operating instructions ...................................... 4
1.2 Intended use ...................................................... 5
1.2.1 Intended use ATMOS®S 201 Thorax ............................... 5
1.2.2 Intended use ATMOS®S 201 Thorax secretion canister ............... 5
1.2.3 Intended use ATMOS®S 201 Thorax hose system .................... 6
1.3 Function .......................................................... 7
1.4 Transport and storage .............................................. 7
1.5 Explanation of symbols ............................................. 8
2.0 Safety advice ....................................................9
2.1 Notice ............................................................ 9
2.2 Caution .......................................................... 11
2.3 Warning ......................................................... 12
3.0 Setting up and starting up .......................................13
3.1 Scope of delivery .................................................. 13
3.2 Device overview................................................... 14
3.3 Starting up ....................................................... 15
3.3.1 Charging the battery ............................................ 15
3.3.2 Secretion canister .............................................. 16

4.0 Operation......................................................19
4.1 Explanation of the display .......................................... 19
4.2 Buttons and display symbols ....................................... 20
4.2.1 Buttons ....................................................... 20
4.2.2 Display symbols................................................ 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 Keylock .......................................................... 24
4.7 Therapy progress ................................................. 25
4.7.1 Shorttime ..................................................... 25
4.7.2 Longtime...................................................... 25
4.7.3 Transfer of therapy data ........................................ 26
4.7.4 Reading out the therapy data .................................... 27
4.8 Switcho ........................................................ 28
4.9 User settings ..................................................... 28
5.0 Warning messages ..............................................30
6.0 Functions ......................................................32
6.1 Hose rinsing ...................................................... 32
7.0 Accessories, consumables and spare parts.........................33
7.1 Attachment of the universal bracket (Accessories) ..................... 33
7.2 Attaching the carrying strap ........................................ 34
8.0 Cleaning and care ...............................................35
8.1 General information on cleaning and disinfection...................... 35
8.2 Cleaning of the device surface ...................................... 36
8.3 Recommended disinfectants........................................ 36
8.4 Hygiene plan ..................................................... 37
9.0 Maintenance and service ........................................38
9.1 Basic information ................................................. 38
9.2 Repairs .......................................................... 38
9.3 Handling of rechargeable batteries .................................. 39
9.4 Exchange of fuses ................................................. 39
10.0 Troubleshooting ................................................40
11.0 Technical data ..................................................41
12.0 Disposal .......................................................43
13.0 Notes on EMC (Electromagnetic compatibility) .....................44

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1.0 Introduction
1.1 Notes on operating instructions
These operating instructions are valid from software-version
3.0.40.
These operating instructions contain important notes on
how to operate the ATMOS®S 201 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 the use of the device, 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 period tests in conjunction with professional
execution provide for operational safety and readiness for
use of your ATMOS®S 201 Thorax and are therefore a must
besides regular cleaning.
Maintenance, repairs and period 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 product ATMOS®S 201 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 product ATMOS®S 201 Thorax 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.com.
• 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 Safety advice“ on
page 9 in order to be prepared for any possible dangerous
situations.

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1.2 Intended use
1.2.1 Intended use ATMOS®S 201 Thorax
Name: ATMOS®S 201 Thorax
Main functions: Device for mobile, active, digital thoracic drainage.
Med. indications/ application:
Recovery of the (natural) vacuum in the pleural cavity e.g. after the occurrence of a
pneumothoraxorapleuraleusionbydrainageofairandsecretion.
Drainage of secretion and air after a surgical opening of the thorax.
Specication of the main function: The ATMOS®S 201 Thorax drainage system is a device for
mobile, digital thoracic drainage. The device is meant for the short-term (< 30 days) application
on humans. It is portable, grid independent and has an electronic monitoring system with optical
and acoustic status displays. The device is applied unsterile. However, the secretion canister and
hose system1, are sterile single use products. All thoracic catheters / drains can be applied, which
are intended for thoracic drainage in the intended use of the manufacturer.
User prole:Doctor,medicalsta
Patient population: Patients of all age groups with and without restriction of any kind
Application organ: Thorax
Application time: Short-term use on the patient (< 30 days).
Application site: The application site is the clinical area. The application of the device may only
be applied by healthcare professionals. The secretion canister and hose system are sterile single
use products, and can be applied in the sterile OT area.
Contraindications:
No separate application of the secretion canister and the hose system (this means without basic
device) as gravity drainage.
Noapplicationinambulancesunderemergencyconditionsandinthehomecareeldwhichis
not supervised by healthcare professionals.
Nosuctionofammable,corrosiveorexplosiveuids/gases.
The product is: active
Sterility: Not in case of the basic device. Secretion canister and hose system are sterile.
Single use product / reprocessing:
Reprocessing for the basic device see notes in the user manual. Secretion canister and hose
system are single use products.
1For detailed information about the secretion canister and hose system please refer to the
separate intended uses.
1.2.2 Intended use ATMOS®S 201 Thorax secretion canister
Name: Secretion canister for the ATMOS®S / E 201 Thorax.
Main functions:
Transport of generated vacuum from basic device to patient-sided tube end.
Collection of secretion and air through the secretion hose into the secretion canister.
Med. indications/ application:
Recovery of the (natural) vacuum in the pleural cavity e.g. after the occurrence of a
pneumothoraxorapleuraleusionbydrainageofairandsecretion.
Drainage of secretion and air after a surgical opening of the thorax.
Specication of the main function: Generation of a vacuum from the thoracic drainage
system through the secretion canister and hose system to the patient-sided tube end. In this
way secretion and air can be sucked through the hose system or transported into the secretion
canister.Abacteriallterinthesecretioncanisterprotectsthebasicdevicefrompossible