Atmos C 051 Thorax Operating Instructions Manual
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Atmos C 051 Thorax Operating Instructions Manual

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

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  • Page 1 Operating instructions ATMOS C 051 Thorax ® 317.0000.B 2014-01 Index: 02...
  • Page 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) atmos@atmosmed.de www.atmosmed.de...

  • Page 3: Table Of Contents

    6.0 Functions ............................... 29 6.1 Hose rinsing 7.0 Accessories, consumables and spare parts ..................30-32 7.1 Attachment of the universal bracket 7.2 Attaching/removing the ATMOS C 051 Thorax to/from the universal bracket 7.3 Connecting of shoulder belt 31-32 8.0 Cleaning and care............................ 33-35 8.1 General information on cleaning and disinfection...

  • Page 4: Introduction

    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 ® 051 Thorax and are therefore a must besides regular cleaning.

  • Page 5: Intended Use

    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...
  • Page 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 finally into the patient side drain 2. Collection of the exhausted secretion Specification 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 filling quantity is 800ml. A bacterial filter prevents the accidentally absorption of secretion into the pump head.

  • Page 7: Contraindications

    Suction of flammable, corrosive or explosive fluids / gases.  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.

  • Page 8: Transport And Storage

    Transport and storage The transport of the device may be effected only in a dispatch carton upholstered and offering sufficient  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 first  time following transport at temperatures below freezing. The unit may not be operated if it has not acclimatised as this might damage its diaphragms.

  • Page 9: Explanation Of Symbols

    t Pictures contained in this manual Warning,  Important information special diligent notice! Symbols of ATMOS C 051 Thorax & Accessories Application part The CE sign shows that Multiple use of compo- nents marked with type BF this product meets is not allowed.

  • Page 10: Safety Advice

    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 ...

  • Page 11: Notice

     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.

  • Page 12: Caution

    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.

  • Page 13: Warning

     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.

  • Page 14: Setting Up And Starting Up

    3.0 Setting up and starting up 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.

  • Page 15: Device Overview

    Light sensor  Clips for carrying strap Back side:  Connection for secretion canister (right) Measuring and rinsing hose (left)  Connection for clips  Identification plate 317.0000.0 ATMOS C 051 Thorax  Canister guide Connection for USB flash drives...

  • Page 16: Starting Up

    Attention! Prior to the fi 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 a cool place without direct solar irradiation. At ambient temperatures above 25°C the charging time could be prolonged drastically.

  • Page 17: Secretion Canister

    (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...

  • Page 18: Exchanging The Secretion Canister

    3.3.2.4 Exchanging the secretion canister 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 3. Place the secretion canister safely on an even surface. 4.

  • Page 19: Operating

    Operating Explanation of the display Target vacuum Display of the preadjusted target vacuum to which the pump adjusts Flow Display of the actual System information 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.

  • Page 20: Buttons And Display Symbols

    Buttons and display symbols 4.2.1 Buttons Figure Function Decrease target vacuum / in the menu: decrease selected value Increase target vacuum / in the menu: increase selected value Grafic diagram of the therapy Open the user settings Save entry Confirm entry Back / Exit menu Warning / suppress the warning Changeover to vacuum scaling Changeover to time scaling...

  • Page 21: Switch On

    Upcoming warning suppressed Safety check required Switch on 1. To switch on the ATMOS C 051 Thorax please touch the ® sensor above of the symbol for 2 seconds. 2. The welcome monitore appears with the software version number in the bottom right corner.

  • Page 22: Leakage Test

    Leakage test Following device start-up the leakage test starts automatically. The patient connection towards the drainage catheter should be closed by a steril plug or clamped during start-up. If the leakage test is error-free, the message „Leakage test OK“ appears. Now you can remove the plug from the hose.

  • Page 23: Function

     The ATMOS C 051 Thorax has a vacuum adjustment. This means, that the integrated pump only runs, ®  if the actual vacuum doesn't correspond to the target vacuum. On the other hand the pumps performance depends on the difference between the actual vacuum and the target vacuum.

  • Page 24: Release Of Key-Lock

    Release of key-lock The ATMOS C 051 Thorax has an automatic key-lock. ® If the settings are not changed for a defined time, the key-lock will be activated automaticlly. Therefore accidental operation is prevented. (Factory setting 2 minutes) Deactivation: After a brief contact with the display, the release  button appears.

  • Page 25: Therapy Progress

    Therapy progress Please note that the alarm function of the device is deactivated while viewing the grafi cal diagram. For the safety of your patient, this modus should only be used for a short time. The ATMOS C 051 Thorax has 2 grafi cal diagrams ® to analyse the development of Air-Flow and actual vacuum. Selection menu By selecting the button you reach the grafi cal diagram modus.

  • Page 26: Switch Off

    0 - 100 mbar (= cm H2O) and 0 - 20 mbar (= cm H Switch off To switch off the ATMOS C 051 Thorax stop the therapy and touch the ®  sensor for 2 seconds. The enacting monitor appears and the device shuts down.

  • Page 27: User Settings

    User settings For accessing the user menu please press the control panel. In the user settings you can make the following settings: System language  Vacuum unit  Please press the control panels moving up and down in the menu selection. For entering a selection menu press on the text box.

  • Page 28: System Language

    4.9.1 System language For changing the language please press the control panels When selecting the requested language and pres- sing the control panel the language is saved as system language and the menu is exited. By pressing the control panel you return to the settings menu without changing the language.

  • Page 29: Alarms

    A safety check is required every year. This will be displayed on the device. 6.0 Functions Hose rinsing The ATMOS C 051 Thorax has an automatic hose rinsing function which works periodically.  The rinsing process transports secretion located in the secretion hose into the secretion canister.

  • Page 30: Accessories, Consumables And Spare Parts

    7.0 Accessories, consumables and spare parts 7.1 Attachment of the universal bracket (Accessories) Turning the universal bracket: The universal bracket can be attached – horizontally and vertically - to plates (e.g. table boards), pipes and stands with a diameter up to 40 mm. Pull the fi xing pin from the fi xation at the bottom side of the ...

  • Page 31: Attaching/Removing The Atmos C 051 Thorax To/From The Universal Bracket

    ® universal bracket Attention! Firmly hold the vacuum unit during the whole process. Place the ATMOS C 051 Thorax onto the universal bracket. ®  Ensure that the thread at the bottom of the vacuum unit is positioned directly above the fi xing screw of the stand holder.
  • Page 32 Attach the second carabiner  to the second clip on the drainage.  Now the ATMOS C 051 can be worn over your shoulder. Attaching the drainage unit to a patient’s bed: To attach the device to a patient’s bed exchange the carabiner ...

  • Page 33: Cleaning And Care

    8.0 Cleaning and care 8.1 General information on cleaning and disinfection Prior to cleaning Medical devices such as the ATMOS ® C 051 thorax must always be ready for use and must function reliability. Therefore prior to every application: falls erforderlich The way the device is used determines its reliability and safety.

  • Page 34: Cleaning Of The Device Surface

    Attention! The device should never be autoclaved, rinsed under running water or immersed into any liquids! 8.3 Recommended disinfectants Disinfectant Ingredients (in 100 g) Manufacturer ATMOS Green & Clean SK Alkyldimethylbenzylammoniumchloride <1 g Metasys, Rum (Austria) (application solution) Dialkyldimehtylammoniumchloride <1 g Alkyldimethylethylbenzylammoniumchloride <1 g...

  • Page 35: Hygiene Plan

    8.4 Hygiene plan WHAT WHEN NOTES Manual wipe cleaning Drainage unit Manual wipe disinfection Singele use product -> not Canister suitable for reprocessing exchange after use Singele use product -> not Hose system suitable for reprocessing exchange after use R= Removal, C= Cleaning, D= Disinfection, S= Sterilisation...

  • Page 36: Maintenance And Service

    9.0 Maintenance and service Basic information The device is equipped with a sensitive pressure sensor. Thus, the vacuum unit should undergo a safety check and should be calibrated respectively by the manufacturer or an authorised service centre every two years. This check should also include a check of the battery capacity as well as all parts for wear or damage.

  • Page 37: Handling Of Rechargeable Batteries

    The lifetime of Lithium-Ionic batterys mainly depends on the ambient temperature. On principle batteries are depleted after 2.5 years. New batteries should be fully charged prior to first use. As ATMOS has no influence on the handling of the device, batterys are excluded from the general guarantee. A function guarantee of 6 months is effective. Attention! The use at other charging accessories could result in the risk of...

  • Page 38: Eliminating Errors

    10.0 Eliminating errors Description Possible causes Measures Connect the battery recharger to the device to recharge the battery, Device cannot be switched on Battery completely empty Note that the progress can be checked in the upper left hand corner of the display Fuse defect Control fuses Battery does is not recharge...

  • Page 39: Technical Data

    11.0 Technical data Voltages 100- 240 V~, 50/60 Hz IEC socket IEC320, type 14 Power consumption Power input max. 60 W Direct current voltage 12 V DC +/- 2 %, max. 4 A via cable,1.8 m length with plug 5.5 x 2.5 Rechargeable battery, built-in Lithium-ionic, 14.4 V nominal, 2250 mAh Operation time...

  • Page 40: Disposal

    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 tubes must be removed. The device...

  • Page 41: Notes On Emc

    13.1 Guidelines and Manufacturer‘s Declaration - Emissions The ATMOS C 051 Thorax is intended for use in the electromagnetic environment specifi ed below. The customer or ® user of the ATMOS C 051 Thorax should ensure that it is used in such an environment. ® Electromagnetic Environment Emissions Test Compliance - Guidance HF emissions acc.
  • Page 42 13.2 Guidelines and Manufacturer´s Declaration - Immunity The ATMOS C 051 Thorax is intended for use in the electromagnetic environment specified below. The customer or ® user of the ATMOS C 051 Thorax should ensure that it is used in such an environment. ® Electromagnetic Envi- Immunity Test IEC 60601-Test Level Compliance Level ronment - Guidance ±...
  • Page 43 40 % U 40 % U the user of the (60% Dip of the U (60% Dip of the U ATMOS C 051 Thorax ® for 5 Cycles for 5 Cycles demands continued func- tion even in case of 70% U...
  • Page 44 13.3 Guidelines and Manufacturer´s Declaration - Immunity The ATMOS C 051 Thorax is intended for use in the electromagnetic environment specified below. The custo- ® mer or user of the ATMOS C 051 Thorax should ensure that it is used in such an environment. ® IEC 60601- Electromagnetic Environment - Immunity Test Compliance Level...
  • Page 45 ® rence by maintaining a minimum distance between portable and mobile RF Communications equipment and the ATMOS C 051 Thorax as recommended below, according to the maximum output power of the communi- ® cations equipment. Separation distance, depending on transmit-frequency m...
  • Page 47 ATMOS MedizinTechnik GmbH & Co. KG in accepting such goods or payment arrears. Acts of God or stoppages upon in writing by us.

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