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ATMOS® S 201 Thorax
312.1000.B
2014-08 Index: 33
2
Further information, accessories, consumables andspare parts are available from:
ATMOSMedizinTechnik GmbH & Co. KGLudwig-Kegel-Straße 1679853 LenzkirchDeutschland / Germany
Tel. +49 7653 / 689-0Fax: +49 7653 / 689-190 +49 7653 / 689-292 (Service Center)[email protected]
Table of contents5.0 Cleaning ...................................................................... 215.1 General information on cleaning and disinfection ........ 215.2 Cleaning the device surface ......................................... 21
6.0 Maintenance and service ........................................... 226.1 Basic information .......................................................... 226.2 Reprocessing ............................................................... 226.3 Battery handling ........................................................... 226.4 Exchange of fuses ........................................................ 22
7.0 Trouble shooting ...................................................... 213
8.0 Accessories, consumables and spare parts ........... 248.1 Accessories .................................................................. 248.2 Consumables ............................................................... 248.3 Spare parts ................................................................... 24
9.0 Technicalspecifications ............................................ 25
10.0 Checking / Reprocessing / Disposal ........................ 2610.1 Checking ...................................................................... 2610.2 Reprocessing ............................................................... 2610.3 Disposal ....................................................................... 26
11.0 Notes on EMC ........................................................ 27-29
General Standard Terms and Conditions
1.0 Introduction ............................................................... 3-61.1 Notes on operating instructions ...................................... 31.2 Intended use .................................................................. 31.3 Contraindication ATMOS® S 201 Thorax ........................ 31.4 Warnings ........................................................................ 31.5 Precautions .................................................................... 41.6 Function ......................................................................... 41.7 Explanation of pictures and symbols .............................. 51.8 Scope of supply ............................................................. 61.9 Transport and storage .................................................... 6
2.0 For your safety ............................................................. 7 3.0 Setting up and starting up ........................................ 8-93.1 Setting up ...................................................................... 83.1.1 Display / Operating elements ........................................ 83.2 Starting up ...................................................................... 83.3 Functional test ................................................................ 93.4 SD Card recording ......................................................... 9
4.0 Operation ............................................................... 10-204.1 Adjust vacuum .............................................................. 104.2 Suction procedure ........................................................ 104.3 Hose rinsing ................................................................. 104.4 Battery recharging ........................................................ 104.5 Container ...................................................................... 114.5.1 Filling the water lock ..................................................... 114.5.2 Pop-off valve ................................................................ 114.5.3 Insertion of the container .............................................. 114.5.4 Hose holder at the container ........................................ 114.6 Connect hose set ........................................................ 124.7 Universal support (optional) ........................................ 124.8 Information on the display ........................................... 134.9 Display function ........................................................... 134.9.1 Switch on menu ........................................................... 134.9.2 Adjusting the vacuum .................................................. 134.9.3 Leakage test ................................................................ 134.9.4 Keylock ........................................................................ 144.9.5 Exchange of container ................................................ 144.9.6 Canister for gravity drainage system ........................... 154.9.7 Switch off ..................................................................... 154.10 Settings menu ............................................................. 164.11 Alarm ........................................................................... 174.11.1 Alarm history ............................................................... 184.12 Flow, time and vacuum display .................................... 184.13 Insertion and removal of the micro SD card ................. 204.13.1 Monitoring the progression of therapy via micro SD card .............................................................. 204.14 Connection to the nurse call system ............................ 20
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These operating instructions contain important notes on how to operate the ATMOS® S 201 Thoraxsafely, correctly and effectively. Their reading helps to avoid risks, and also to reduce repair costsand 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. Reproduction of these instructions – even in part – only with the written permission of ATMOS.These operating instructions must always be kept available near the device.
Care and safety inspections in conjunction with professional execution provide for operational safetyand readiness for use of your ATMOS® S 201 Thorax and are therefore a must besides regular cleaning.Repair work and safety inspections may be carried out only by expert personnel authorised byATMOS. By applying only original spare parts you will have the guarantee that operational safety,readiness for work and the value of your ATMOS® S 201 Thorax will be preserved.
●The product ATMOS® S 201 Thorax bears CE marking 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 can be obtained on our website at www.atmosmed.com.●The quality management system applied at ATMOS has been certifi 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 Introduction1.1 Notes on operating instructions
1.2 Intended use1.2.1 Intended use of the ATMOS® S 201 Thorax
Main function: Mobile digital thoracic drainage system
Medical indication/application: 1. Restoring the natural vacuum and the natural fl uid balance in the pleural cavity after a pneumothorax or a pleural effusion. This is achieved by drainage of air and secretion.2. Drainage of secretion and air after surgical opening of the thorax.
Specificationofthemainfunction: The digital drainage suction systems ATMOS S & E 201 Thorax are devices for mobile thoracic drainage. They are intended for short-time (<30 days) application on human beings. They are portable, mains-independent and have an electronic monitoring sy-stem with optical and acoustic status display. The products are used in unsterile condition, except the hose set and the collection canister, which are sterile single-use products. Any trocars and catheters may be used which their manufacturers have intended for use in thoracic drainage.
Patient group:Patients with thoracic injuries who need pleural cavity drainage for maintaining the lung function. Furthermore, it is used for pati-ents who had a surgical intervention which requires the drainage of blood and secretion from the thoracic cavity.
Application organ: Thorax
Application duration:Under normal condition it is intended for continuous application over a period of less than 30 days (short-term).
Application environment:Application environment is the clinical area. The application of the vacuum unit may only be performed by healthcare professio-nals. Secretion canister and drainage hose are sterile single-use products which are used in a sterile surgical environment.
The product is: Active
Sterility: Not for the basic unit
Single-use product/reprocessing: Reprocessing for basic device
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1.4 Warnings:● Patient hose clamp must remain open during drainage operation.● The device is not for use while bathing, showering nor suitable for a hazardous explosive environment.● Do not use this device in MRI (Magnetic Resonance Imaging).● Do not dry the device with microwaves. ● Chest hoses should not be clamped except when changing the canister. In the event of an airleak, clamping chest hoses could lead to a tension pneumothorax.● The ATMOS® S 201 Thorax must remain in an upright position during use.● The patient should be regularly monitored according to internal hospital guidelines.● ATMOS® S 201 Thorax is a medical device that requires special safety precautions and must be installed and placed in operation in accordance with the attached EMC information. Portable and mobile RF communication devices (mobile telephones) can affect the drainage system.● A replacement device must always be available for patients for whom a breakdown of the device can lead to a critical situation. ● Do not separate patient hose in-line connector prior to clamping off patient hose fi rst. ● Do not keep patient hose clamp closed during drainage collection or patient transport.● Please note that when the set pressure is -50 mbar or higher this high pressure can cause pain or injuries to the patient.
1.2.2 Intended use of the secretion canister for ATMOS® S 201 Thorax
Name: Sterile secretion canister for the exclusive connection to the ATMOS® E / S 201 Thorax.
Main functions:Forwarding of the created vacuum into the drainage hose and fi nally into the patient side drain.Collection of the exhausted secretion.
Med. indications/ application: Secretion canister for the connection to a digital device for mobile thoracic drainage.
Specificationofthemainfunction:The vacuum generated by the pump evacuates air and secretion out of the drain. The secretion is collected in the secretion canister whose fi lling quantity is 2 l. A bacterial fi lter prevents the potential contamination of the room and the device by bacteria. Additionally it prevents the accidental intrusion of secretion into the pump head. A sterile 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 measuring hose inside of the tubing system, which is also provided with a fi lter, the actual vacuum on the drain will be measured. Furthermore the measuring hose is also responsible for the fl ushing of the secretion hose with atmospheric air.
Application organ: Thorax
Application time: Short-term use on the patient (< 30 days).
Application site: Application environment is a clinical area. The application of the canister 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: No application of the canister with other low vacuum devices than ATMOS® E / S 201 Thorax.
The product is: □ active X not active
Sterility: Sterile
Single use product / reprocessing: Sterile single use product
1.3 Contraindications of ATMOS® S 201 Thorax
In ambulances in service and in the home care fi eld which is not supervised by healthcare professionals.
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1.6 FunctionThe ATMOS S 201 Thorax is a particularly useful small suction unit. The device is operated by an electromotive, maintenance-free piston pump. During operation the pump creates a vacu-um in the hose system and in the collection jar, with the help of which secretions can be sucked through the set of hoses.The pump switches off after creation of the pre-adjusted vacuum and switches on again only, when the vacuum lies below a certain tolerance.The real-time measured flow is shown as numerical value. At one keypress flow data from up to 12 days are shown in a graphic.The secretion is collected in the collection jar, the capacity of which is 2l. The vacuum at the trocar is measured by means of the measuring pipe in the set of hoses. The final vacuum can be adjusted with the buttons on the operating foil. If required, the air-flow rate is automatically adjusted. The device adjusts and keeps the pre-adjusted vacuum automatically in case the negative pressure in the pleural cavity varies. In this case the pump starts to balance the negative pressure until the pre-ad-justed vacuum is reached again and then switches off. These compensation values, which may vary heavily, can easily be read on the display. At regular intervals the device rinses the suction hose with air so that deposits in the suction hose are avoided and it prevents secretion from penetrating the measuring channel.The device is fitted with a rechargeable battery. A micro-processor controlled electronic charging unit in the suction device guarantees the safe charging of the battery, and thus overcharging of the battery is avoided. In addition a bacterial filter located in the cover of the collection jar prevents the entry of bacteria and secretion into the interior of the device. There is a carrying strap available for mobile use. A practical carrying bag and a bed mounting are accessories that can be ordered.
1.0 Introduction
1.5 Precautions● Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.● Cointainer and hose set are for single patient use and for one time patient connection only.● Do not resterilize this device. Container and hose are single-use products, there is a high risk of infection in case of re-use. The container cannot be emptied .● Air vent must remain closed at all times when not in use.● All hospital protocols for disposal handling and infection controI should be carefully followed.● The function of the device must be checked prior to use (see chapter 3.0 – Setting up and starting up; section 3.3 Functional test)● When a thoracic catheter is connected leaky connections may result in an incorrect evaluation of air leaks from the lung and delay treatment time. Therefore check that all the connections are airtight to prevent air from entering from the atmosphere.● During set up, an incorrectly positioned drainage system and patient tube may impair fluid and air evacuation. Total obstruction of fluid and air evacuation can cause an increase in positive pressure and possible tension pneumothorax. Therefore position the drainage system below the level of the patient`s chest and check that the patient tube does not form loops or kinks, impairing drainage of fluid and air.● General. Check that all the connections are airtight. If the thoracic drainage unit tips over it is advisable to set it up right again to guarantee operation and to be able to re-determine the volume and appearance of the drained fluid. If there is the slightest uncertainty about the operation of the drainage system after it has tipped over, it is recommended that a new drainage system be installed to ensure the patient‘s safety. ● Keep the AC adapter connector away from moisture. ● Keep the power cord away from hot surfaces.● Do not overfill water seal above the 2cm fill line.● Water seal must be fi lled to prescribed level prior to use and should be checked regularly to confi rm proper operation.● Use only pre-packaged sterile fluid for filling the water seal.● When inspecting the collection chamber routinely check the volume and appearance of the drained fluid and inform the responsible clinician of abnormalities. Exceeding the recommended collection volume can cause obstruction of fluid and air evacuation and may therefore result in an excess pressure pneumothorax. Always replace the canister when the maximum volume is reached to ensure the patient`s safety. Replace chest drain if damaged. Patient tube connections and water seal, should be checked regularly to confirm proper operation.
a.) Installation. The product must be used at room temperature and should not be placed in direct sunlight as this may result in measurement errors.
In case of noncompliance and misuse of the ATMOS S 201 Thorax any guarantee claims shall expire and ATMOS Medizin-Technik GmbH & Co. KG assume no liability.2
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1.7 Explanation of pictures and symbols
1.0 Introduction
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■
●
→
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 informationFollow the arrows whilst proceeding, sequence
Replace
Check
Please read, important information
Move, plug ... in this direction
Engage, check correct fit
Turn, shift ... in this direction
Important information
Operating keys / symbols of the ATMOS S 201 Thorax
Serial number
Order number
Manufacturing date
The CE sign shows that this product meets the appropriate requirements of the EC guidelines.
Fuse
Protection class II
Application part type CF, defibrillator-proof,recovery time: 10 sec
REF
SN
OFF = long keypress (supply, disconnection from the mains)
ON = short keypress (supply, connection to mains)
Adjustment keys ▲▼
Reset / Enter
Flow
Please observe operating instructions!
This product is not re-sterilisable. Repeated reuse of components which are marked with a is forbidden. In case of repeated reuse these compo-nents lose their function and there is a high infection risk.
22Sterile unless package is damaged or open
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1.0 Introduction
1.8 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).
1.9 Transport and storage● The transport of the device may be effected only in a
dispatch carton upholstered and offering sufficient pro-tection.
● Please document and report damages in transit imme-diately. For complaints or return deliveries, please use the enclosed form QD 434. The form QD 434 can also be downloaded from the internet 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 piston.
● Ambient conditions: Transport/Storage: -10...+50°C; 30...95 % air humidity non-condensing at air pressure 500...1060 hPa
Operation and +10...+35°C; battery charging: 30...95 % air humidity non-condensing at air pressure 700...1060 hPa
Basic device
Container set, sterile packed (Must be ordered separately!)
Operatinginstructions
Hose setsterile packed (Must be ordered separately!) Power cord
Micro SD card
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!For your safety
2.0 For your safety
Dispose of the packing material in a proper manner.
Before the device is connected a check must be made to see that the mains voltage and mains frequency given on the device agree with the values of the supply system.
Only regular and undamaged mains connection and extension cables must be used.
The suction hose must not come directly into contact with the suction place but only through a sterile drain.
To disconnect the device from the mains first pull out the plug from the wall socket. Only then disconnect the connection cable from the device. Never touch the plug or cable with wet hands.
The environmental conditions given in the Technical Specifications (section 9.0) must be observed.
The control panel should always be clearly in view for the operators and be easy to reach.
The ATMOS S 201 Thorax meets the resistance to jamming of the standard IEC 60601-1-2/EN 60601-1-2 „Electro-magnetic compatibility - Medical electrical devices“.
No guarantee claims can be accepted for damage which is produced by using third party accessories or third party consumable materials.
ATMOS is not responsible for damage to people or goods if • non-original ATMOS parts are used, • the information in these operating instructions are disregarded, • assembly, new installations, modifications, extensions and repairs are done by people who are not authorised by ATMOS.
These operating instructions correspond to the design of the device and the situation of the safety standards on which they are based when they were printed. The circuits, processes, names, software programmes and devices are all covered by patents.
Please only use ATMOS containers with integrated bacteria filter and ATMOS hoses with integrated bacteria filter in the measuring channel.
The container may not be used without device.
This product is not re-sterilisable. Repeated reuse of components which are marked with a is forbidden. In case of repeated reuse these components lose their function and there is a high infection risk.
Attention loss of data Removal of the SD card during operation of the thoracic
drainage device means that the currently written file is deleted! The actual therapy recording will be lost!
The ATMOS S 201 Thorax is designed in accordance with IEC 60601-1/EN 60601-1. It is a device which meets the VDE protection class II. It may be connected to a properly installed wall power point socket.
Before commissioning the device, drainage container, mains cables, accessories, connecting leads and hoses should be checked for damage.
Damaged leads and hoses must be replaced immediately. The function of the device should be checked prior to use.
The ATMOS S 201 Thorax may only be used by trained specialist staff.
The ATMOS S 201 Thorax is not designed for operation within areas where there is a risk of explosion (M and G) and in oxygen rich environments. Areas that are at risk from explosions can arise due to the use of combustible anaesthetics, skin cleaning and skin disinfecting materi-als.
No liquid may enter the device. If liquid has entered the device it must be checked by the customer service before it is used again.
After a long journey at temperatures under the freezing point the device must be allowed to stand for up to six hours at room temperature before it is used for the first time. If the device is not acclimatised, it must not be operated, since the piston of the unit might be damaged if it runs in this condition.
Only trained staff may remove the container from the device during therapy.
Prior to use the perfect function of optical and acoustic alarm must be checked by the user.
Prior to use the nurse call function (menu item) must be
tested.
For hygienic reason we recommend to exchanged the hose always together with the container.
Uncoupling of the device may only be performed if the maximum target value of 15 mbar is reached.
Disinfectant should not enter the device. If disinfectant has penetrated the device, then it must be dried tho-roughly and subsequently an efficiency control must be conducted. It must be both checked, whether the target vacuum is reached when the system is closed and whether a flow >10 l/min is reached after a while when the system is open. If not, the device must undergo a service check prior to being used again.
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3.0 Setting up and starting up
3.1.1 Display / operating elements
Symbol „start pump“ On/off switch Symbol „stop pump“ Display ▼ adjusting key ▲-adjusting key
Enter / Menu / Reset Therapy progress key
3.1 Setting up
●Set up the device on a level, firm surface.●Connect the mains cable when charging the battery.
Mains voltage and fuse:
Mains voltage: 100-240 V; 50/60 HzFuse: 1 x T 1A, L
● USA/ Canada: Use only „Hospital Grade“ mains plugs and cords with
remark: Grounding reliability can only be achieved when the equipment is connected ...). Cord type shall be SJ-type and not smaller than 18 AWG and comply with CSA C22.2No.21.
● Australia: Use only cords with plug Type AS 3112.
● Singapore: Plugs shall be rough-use-type, marked with „SS 145/A“.
● Denmark: Plugs and sockets shall appply SB 107-2-D1, 3rd Edition
Plugs: DK 2-Ia, DK 2-Ia with flat phone pin or DK 2-5a, Socket outlets: DK 1-3 a.
3.2 Starting up
Operating panelHandle Measuring channel Suction channel Display Secretion container Device status (LED)
● Lift the unit out of the cardboard. Check whether the voltage values on the data plate correspond with the inbuilding voltage.
● Set up the device on a level, firm surface.
●Prior to first operation, pay attention to the safety informa-tion in chapter 2.0.
● Prior to first start up the battery must be fully charged.Charging time approx. 2.5 h.
● 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 piston.
● The device can only be operated with the special ATMOS container, therefore please take care to have at least one spare container available.
Fig 1
Fig 2
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3.3 Functional test
Mounting of the ATMOS S 201 Thorax as described under Fig. 2.
Before use the system must always be tested regarding any leakage.
Slip on the test hose set to the device and connect the patient side of the hose to the sealing cap (blue plastic part) at the secretion container. Use gloves!
Start the devices in pressing the key . A leakage test is performed automatically by the device. Please press Enter to continue.
The permeability can be checked over a longer period when the device has reached the Standard Screen (Fig. 8). Switch the pump on „ ► „ by briefly pressing button when the target vacuum is achieved, switch the pump off „ II “ by again briefly pressing button 4. The actual vacuum should not fall by more than 12 mbar within10 secs when the hose end is closed.
In case the leakage test was successful Fig 4 appears on the display. Please confirm with key (Fig 3).
If the leakage test was not successful, please switch off the device and check all the connections (hose, contai-ner, etc.). Restart leakage test in starting up the device.
If need be re-establish permeability (check hose connections).
Switch over to standard mode ensure the pump is off „ II “,
3.4 SD card recording
After the leakage test the readout as shown in figure 5 or figure 6 appears automatically on the display.
The readout shown in figure 5 indicates that no SD card is in the device or a new card is being used. Please insert the SD card and select “read in SD card“ again or select “therapy start with new recording” using the ▲ and ▼ buttons.
In case therapy should not be recorded, please select “therapy start without recording”.
When the SD card is already inserted prior to start up, the readout as shown in figure 6 appears on the display. It is possible to select either “continue previous recor-ding” or “start new recording” with the ▲ and ▼ buttons.
3.0 Setting up and starting up
Fig 3
Fig 4
Fig 5
Fig 6
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4.0 Operation
Important notes on safety
for the secretion container system
!
20
% 4
0 %
60
% 8
0 %
100
%
4.2 Suction procedure
● After setting the target vacuum the drainage system builds up and controls the set negative pressure automatically as long as the pump is switched on.
The bacterial filter is a safe protection against liquid penetrating the pump.
4.3 Hose Rinsing
An automatic hose rinsing function will operate periodically. This rising function is designed to draw any secretion or fluid build-up in the measurement hose into the suction hose and subsequently the secretion container.
If the water lock function is being used, air bubbles are likely to appear during the hose rinsing period. Users should be aware that these air bubbles that appear at regular intervals (usually 5 mins), are not related to the patient’s condition (e.g. fistual).
The hose irrigation is inactive if the actual vacuum value is between -10 and 0 mbar.
Adjust the target vacuum with the keys▼▲. The basic setting is -20 mbar. This value can be changed in the settings menu.
Depending on the selected vacuum unit, the target vacuum can be set in 1mbar or 1kPa steps. NOTE: 1kPa = 10mbar, therefore when kPa is selected, the vacuum range is 1kPa to 10kPa.
●Only use the original ATMOS single-use secretion container!
● Vacuum connection The vacuum connection between the pump and the collection jar is created automatically as soon as the secretion container is positioned correctly.
A yearly calibration and safety-related check is prescribed. Send in the device to the manufacturer or an authorised partner.
4.4 Battery rechargingThe battery is recharged by the integrated recharging electronics as soon as you connected the device to the mains supply with the power cord. Please note the information on how to handle rechargeable batteries in chapter 6.3.
Charging condition:
Please take care not to expose the device to any source of heat during recharging as this would reduce the available charging capacity and increase the recharging period.
Correct handling of the rechargeable batteries prolongs their maximum service life.
Rechargeable batteries are wearing parts and therefore exclu-ded from the 2 years‘ product liability!
4.1 Adjust vacuum
●For hygienic reasons we recommend to exchange the hose always together with the container.
Fig 7
Fig 8
20
% 4
0 %
60
% 8
0 %
100
%
12
4.0 Operation4.5 Container
Pop off valve Filler for water lock Hydrophobe bacterial filter Filling level for water lock function Indicator scale for balancing in ml Connection towards patient (secretion channel) Protective cap for sealing the secretion channel Protective cap for sealing the pop off valve
4.5.1 Filling the water lock
The water lock is on the right side of the container. A bacteria filter and a riser are included. The water lock is filled with water through the riser. For filling the water lock a sterile cannula 20 G, a sterile syringe and 50 ml sterile water are required. With the cannula you may puncture the silicone seal above the riser and then fill the water lock. Repeat this procedure until the water lock is filled up to the 2 cm filling mark.
Reconnect the filled container to the device as described under 4.5.3.
During normal operation the fi lling of the water lock isoptional.
The container may only be removed when the pump is switched off.
Prior to inserting the secretion canister into the device, make sure that the filler of the water lock is sealed with the plug.
4.5.2 Pop off valve The pop off valve releases in case of overpressure (e.g. coughing fits) .
4.5.3 Insertion of the container
Connect the filled canister to the device. Insert the new container (fig 9). Insert the rear left edge of the container in an angle of approx. 30° to the housing wall and move the container to the left until it engages. Then move the container towards the housing until it clicks into place (Fig 10). The ATMOS S 201 Thorax is again ready for use. Reopen the clamp at the suction hose.
4.5.4 Hose holder at the container
Please reorder the hose holder under REF 312.1029.0. Pull off the adhesive strip and fix the holder as shown in fig 11.
click
Fig 9
Fig 10
Fig 11
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!
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13
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4.6 Connect hose set
Measuring channel Suction channel Sealing cap for closing the secretion channel
Measuring channel:Attach the luer connection with integrated filter to the measu-ring channel and turn it to the right.
Suction channel:Attach the luer connection to the measuring channel and turn it to the right.
The vacuum is measured directly with the measuring channel at the drain. A bacterial filter prevents the measuring channel from contamination with bacteria and the penetration into the device. The secretion is sucked off through the suction channel.
A double-lumen hose system is indispensable! Both hoses must be connected. The hose set is a single-use product for use with one patient only.
When using other hose systems this may lead to damage of the device.
4.0 Operation
4.7 Universal fastening (optional)
The fastening can be mounted to infustion tripods, wheelchairs, to the bed or to the standard rail. Arrest the adjusting lever , hereto please pull out the pin and rotate the adjusting lever up to the required position (in 90° steps) until the pin engages automatically. Fix the adjusting lever .
Please take care that the screw is screwed in prior to put the ATMOS S 201 Thorax onto the support!
Put the ATMOS S 201 Thorax onto the support.
Slightly pull out the upper button and rotate it by 90° until the two connectors are at the level of the holes and then release the button.
Fig 13
!
!
Fig 12
!
4.0 Operation
4.9.3 Leakage test
Perform a leakage test (see chapter 3.3). If the leakage test failed, please repeat the test.
Only exit this menu when you wish to start the therapy.
4.9 Display functions
4.9.1. Switch on Switch on the ATMOS S 201 Thorax with the I/O key.
The start screen is shown for 2 seconds.
4.9.2 Adjusting the vacuum
Adjust the target vacuum with the keys▼▲. The basic setting is -20 mbar. The last selected value is stored and is adopted as the target value during the next start up of the device.
4.8 Information on the display
Actual vacuum Target vacuum Air flow Display of airflow Alarm signal Service display Please call customer service Alarm signal is suppressed Pause (stop pumping) Key lock Battery status
Fig 14
Fig 15
Fig 16
Fig 17
Fig 18
Flow displayed as bubbles:
Each additional dark colored bubble represents an additional flow.
From 1 to 9: 0,25 l/min (blue) from 10 to 12: 3,30 l/min (red)
15
click
4.0 Operation4.9.4 Key lock
For manual activation of the key lock, please press keys ▲ and ▼ simultaneously until the keylock symbol is displayed on the screen.
After switching on the device the key lock is automatically activated if no key is operated within the preselected period. The period for activation can be adjusted in the settings menu between 1 ... 20 min (see chapter 4.9).
If the key lock is activated, the key symbol is shown on the display. For deactivation, please press the buttons ▲ and ▼ simultaneously until the keylock symbol is no longer displayed on the screen.
4.9.5 Exchange of cthe canister
Uncoupling of the device may only be performed after pinching off the hose and if a target value of 15 mbar is reached.
Brieflypress the I/O key, the pump stops. The symbol II appears. Pinch off the hose near to the patient. Close the suction hose close to the patient using a clamp in order to prevent from loss of vacuum.
Press the release button and swivel the canister system forward until the canister can easily be removed from its guides . Disconnect the canister from the hose system and the secretion channel. Seal the secretion channel and the pop off valve with the protective caps (see chapter 4.5).
First seal the port for the patient hose. Remove the cap of the pop-off valve by rotating and tearing it away. There is no need to seal the connection to the device because the bacterial filter is covered with a self-sealing coating.
Please wear gloves. Dispose of container separately.
Insert the new canister (fig 20). Insert the rear left edge of the container in an angle of approx. 30° to the housing wall and move the canister to the left until it engages. Then move the container towards the housing until it clicks into place. The ATMOS S 201 Thorax is again ready for use. Start up the pump by pressing the I/O key. Reopen the clamp at the suction hose.
Exchange the canister at the latest when a filling level of 1900 ml is reached.
Fig 19
Fig 20
!
Flow displayed as bubbles:
Each additional dark colored bubble represents an additional flow.
From 1 to 9: 0,25 l/min (blue) from 10 to 12: 3,30 l/min (red)
16
4.0 Operation
4.10 Settings menu
With a long depress of the menu key (3 seconds) you can enter the settings menu. The first activated dialog box is „language“. By pressing the ▲ or ▼ key you may switch from one dialog box to the next. You activate the setting in pressing the enter key. You select the requested setting within the dialog box in pressing the ▲ and ▼ key and confirm the setting in pressing the enter key again. You may then switch to the next menu item with the ▲▼ keys. If all settings are made, exit the settings menu in depressing the menu item „exit“ and confirm with the enter key on the display. Your settings are also saved after switch off of the ATMOS S 201 Thorax.
SubmenusEnter/ Return to relevant submenus
Language
Vacuum- unit
Default- vacuum
Display brightness
German English French Italian Spanish
mbar kPa
5....................................................................................................................100 mbar
1............................................4
Time hh:mm:ss
Date dd-mm-yyyy
Factory settings
Fig 22
Alarm History
Clear Alarm History
1...................10 Alarms
Yes No
Display contrast
1............7................................15
Keypad Tone
Yes No
Keylock Activation Time
1 min......5 min.......................20 min
Exit menu
Fig. 21e
4.9.6 Switch off
To switch off the device, press the I/O button for 3 seconds.
17
4.0 Operation!4.11 Alarm The key lock is automatically deactivated if the alarm is activated!
Display Cause of defect Troubleshooting
Vacuum low
In case the final vacuum cannot be reached an acoustic and optical alarm is released and „vacuum low“ is readout. Possible cause for this error message: Leakage, blocked bacteria filter or any blockage in the measuring channel or secretion in the pump.
Check connections and hoses.
Vacuum highWhen an excessive vacuum is measured the „vaccuum high“ alarm is activated (acoustic and optical).
Check the hose system.
Battery lowIn case the battery voltage falls below a certain value the alarm signal (acoustinc and optical) for „battery low“ is activated.
Connect the device to the mains, batte-ry is recharged and charging condition is displayed.
System blockedThe information that the system is blocked is activated.
Check the hose and in case the filter is blocked, exchange the container with the filter.
In order to suppress the alarm in case of alarm signalling, please press the key.The alarm continues to be displayed until the condition for the alarm is resolved (eg. target vacuum achieved, battery rechar-ged).If required, briefly press the I/O key to turn off the pump .„ II „. The alarm continues to be displayed until the condition for the alarm is resolved (e.g. target vacuum achieved, battery recharged)!
Further alarm displays you will find in chapter 7.0 Trouble shooting.
Prior to starting up the device the correct function of the visual and acoustic alarm must be checked by the user. In case of alarm the system switches automatically to the alarm menu. An error message is displayed. Below an information on how to solve the problem is shown. Simultaneously the acoustic alarm is activated. The LED is illuminated in orange or red.
Before the device can be used, the correct function of the optical and acoustic display must be checked by the user.Perform the following steps:
1. Attach a canister on the ATMOS S 201 Thorax.2. Connect a hose to the unit. 3. Turn on the power.4. Perform the leak test.5. After passing the leak test, adjust a target-vacuum of 20 mbar or -2.0 kPa.6. Ensure that the end of the connected tubing set (connection point for drainage) is open - the pressure in the tank-tube system corresponds to the ambient pressure.7. Leave the unit for more than 10 minutes in the ON state without starting a vacuum therapy.8. Wait until the device detects a permanent low vacuum and a corresponding alarm sounds.9. Check that the display shows an alarm message.10. Check that an audible alarm signal sounds.11. Check that the status LED blinks red.12. If you have performed all the above steps successfully, the correct function of the optical and acoustic displays is suffici ently controlled.
Fig 23 Fig 24 Fig 25 Fig 26
! The cause of error must always be cleared in case of any alarm message!
18
4.0 Operation
4.12 Flow, time and vacuum displayThe actual flow is readout with an accuracy of 100 ml.The flow, time and vacuum history can be called up by the therapy progress key (Fig 1 ) (short depress). With the key one can switch over between Flow, Time and Vac. With the keys ▲▼, settings can be adjusted, the flow between 0-20 l/min, the time between 30 min and 12 days and the Vac between 0-100 mbar.
Display readout:
In order to exit this menu please shortly depress the menu key again.
4.11.1 Alarm history
You can enter the settings menu by a long keypress of the button (3 sec). The first dialogue field is the field „language“. By pressing the ▲ or ▼ key you can enter the dialogue field „alarm history“ on page 2. Press the button to see the alarm history.
Fig 27
Fig 28
19
4.0 Operation
4.13 Carrying strap
Fix the carrying strap with the velcro fastening to the handle, adjust the requested length of the carrying strap and put the device on.
Fig 29
4.14 Insertion and removal of the micro SD card
Insert the micro SD card upright and with the face up.
Insert the micro SD card into the opening until it locks in place with a „click“.
Close the cover.
For removing the micro SD card, please open the cover and press the micro SD card. It is automatically ejected.
Fig 30
Fig 31
Fig 32
click
20
4.14.1 Monitoring the progression of therapy via micro SD card
Via an integrated SD card, REF 312.2021.0, the stored data can be output in Excel format and assigned to the patient file. This makes it possible to trace the progression of treatment at any later time as well.
Please only remove the SD Card when the device is switched off.
At the beginning of each data logging session, the time and date are recorded on the file. Subsequently, the flow and vacu-um values are saved to the SD Card every 2 seconds. There-fore the time for each of the recorded data samples can be calculated by cumulatively adding 2 seconds to the start time.
4.15 Connection to the nurse call system
The cable may only be made by an electronic specalist.
Prior to use the device, the nurse call system must be checked (service menu item).
The ATMOS S 201 Thorax can be connected to the nurse call system via the nurse call interface (NCI). A stereo phone jack 3.5 mm is required. In the case of an alarm the alarm signalling is transferred to the nurse call system. During each alarm the contact at the phone jack which is connected to the NCI jack T-S is closed for approx. 1 s. The contact R-S is opened during this time.
Check nurse call system (NCS):
● Turn off device in off by pressing and holding …
● After device turned off press and hold and simultaneously until the ATMOS Logo appears.
● The device enters into the service mode
● Now check the menu item “NCS”. It should say “yes”.
● If “NCS” status is “no”, press to activate and press or to change between “yes” and “no”.
● After this procedure just reboot device
T R S
!
!
Fig 33
Fig 34
Fig 35
4.0 Operation
21
5.0 Cleaning 5.1 General information on cleaning and disinfection
Before cleaning
Medical devices like the ATMOS S 201 Thorax must always offer a maximum in safety and function. We therefore recommend prior to each application:
if
necessary
5.2 Cleaning the device surface
If liquid has penetrated the unit, it may not be operated again until it has been checked by the authorised customer service centre. Please note that disinfectant should not enter the device. Do not use a spray disinfectant directly on the device, but spray it on a cloth (only damp not wet). During cleaning and disinfection the device must be switched off. It may only be switched on again if cleaning agents and disinfectants on the device surface are fully dried.
Disconnect the power cord from the mains prior to cleaning and disinfection of the device surface.
● The unit itself can be wiped off with a moist (not wet) cloth.
● The surfaces of the ATMOS S 201 Thorax can be cleaned / disinfected with products of the following active irgredients:
QAV (quartanary ammonium compounds)
Do not use • Disinfectants containing concentrated organic or anorganic acids or bases, since these may cause corrosion damages. • Disinfectants containing chloramides or phenol derivatives since these may cause stress cracks in the material used for
the housing of the unit.
!
The described measures to clean and to disinfect or sterilize do not replace the instructions given in the particular company!
All disinfects used to disinfect ATMOS S 201 Thorax have to be legally marketed disinfectants.
The secretion container and the hose set are single-use products and may not be reprocessed.
Always observe the concentration specifications and instructions by the respective manufacturer!
■ Discolouration may result if disinfectants containing aldehydes and amines are used on the same object.
22
6.4 Exchange of fuses
6.0 Maintenance and servicing
click
+...
+...
!
6.1 Basic information● Carry out a visual inspection of the unit prior to each
use including hoses, collection jar and connection ca-ble. Damaged cables and hoses must be replaced immediately.
● Maintenance or opening and repair of the ATMOS E 201 Thorax may only be carried out by ATMOS or a specialist authorised by ATMOS. In this case, attention should be paid to the protective technical and hygiene measures, the notes on safety plus the descriptions in the servicing instructions for the ATMOS E 201.
● For repair, this device can be returned to ATMOS.
● Before returning the device for repair, it must be tho-roughly cleaned and the surfaces must be disinfected. Please send in the device without container and hoses because for hygienic reasons they would be disposed of during repair.
● 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, • assembly, resetting, alterations, extensions and repairs are not carried out by people authorised by ATMOS.
● No warranty rights shall exist in the event of damage or failure caused by the use of non-ATMOS accessori-es or non-ATMOS consumables.
● When the operating instructions stated in this manual are observed there is no health hazard. Nevertheless, we recommend, depending on the type of applica-tion, the hygienic reprocessing of the device within the scope of the annual calibration and safety-related inspection.
● Pay attention to regulations and instructions valid for the respective application range.
6.2 Reprocessing
The way the suction device is used determines its reliability and safety. These hygiene measures described in the last chapter are indispensable for protecting the patient and the user and for maintaining a safe and reliable suction device.
These measures are no substitute for a reprocessing
of the device by the manufacturer or by a specialist authorised by ATMOS. The device should at least be reprocessed every 12 months.
6.3 Battery handling
● Prior to first use, the battery must be fully charged!
● Deep discharge may destroy the battery. Therefore, please fully recharge the batteries of the ATMOS S 201 Thorax every 3 months, even if the device is not used.
● Battery-run devices should only be stored when they are fully charged.
● If the device was not in operation for a long period of time, the full capacity of the battery can only be achieved when 4 complete recharging and discharging cycles have been completed.
● Used batteries should be replaced immediately by the cu-stomer service. The mains operation of the device with used batteries can destroy the charging electronics respectively excessive power consumption of the device may result in a spontaneous cut-off.
● Heat destroys the batteries. Therefore, please prevent them from direct solar radiation and keep them away from radiators. The perfect storage temperature is between
8 – 15°C.
● The battery should be exchanged by the service depart-ment if the available capacity (operating time) is less than 80 % compared with a new battery.
● Conditional of manufacturing batteries are run-down after approx. 800-900 charging cycles.
● Batteries are consumables.
23
7.0 Trouble-shooting
Description Possible reasons Measures
Device cannot be switched on Battery is fully dischargedConnect the mains cable and recharge the battery; see the charge level indicator on the left in the display
Battery cannot be recharged, symbol for mains connection does not appear in the display although the mains cable is plugged in
Fuse is defective Check device fuse and in-house fuse
Mains cable is defective or not plugged in correctly Check the mains cable
Internal power supply or battery is defective
Device must be checked by the authorised service
Vacuum low
Any leakage Check all the tubing and container on any leakage
Blockage in the hose set
Possible blockage must be eliminated; the measuring channel must be removed briefly from the container lid; in case the filter in the measuring channel is blocked, the hose set must be exchanged
Filter / overflow safety is blockedHose and filter must be checked, if the filter is blocked, the container including filter must be exchanged
Secretion has penetrated the aggregate
Device must be checked by the authorised service
Vacuum high Excessive vacuum is fed from outside Check correct tubing
Battery Low Battery is flatConnect the device to the mains; battery is recharged and the charge level indicator is shown in the display on the left
System blocked In the display it is shown that the system is blocked
Check the hose and if the filter is blocked, the container including filter must be exchanged.
System is shutting down Battery is empty
Connect the device to the mains; battery is recharged and the charge level indicator is shown in the display on the left
High Temperature Please provide sufficient cooling Device Overheated Contact ATMOS Service Recording deleted SD Card removed while recording
Leakage test failed Internal error In case of any leakage during the automatic leakage test, the device must be checked by an authorized service engineer.
Flow readout is always 0 l/min
Component error 1) Please check whether the flow is also 0 l/min when the system is open.
2) Device must be checked by the authorised service
Secretion has entered the device
Service is required.hardware / software fault
Contact ATMOS ServiceService is required. If necessary restart without mains connection.
Contact ATMOS Service. During a restart the error message appears every 30 seconds.
24
8.0 Accessories, consumables and spare parts
Accessories REFUniversal bracketBracket for fastening the ATMOS S 201 Thorax on the patient bed, standard rail, wheelchair, tripod, etc.
312.1160.0
Consumables OT-Set
In the surgical kit included:
Canister for ATMOS S 201 ThoraxDisposable canister system 2 l, with hose-free connection to the drainage system10 pieces
Drainage hose, sterile, L = 1.8 m, 10 piecesExchange: once per patient
312.1031.0
Carrying strap ATMOS S 201 Thorax 312.0850.0Spare partsMicro SD card 312.2021.0
9.0 Technicalspecifications9.1TechnicalspecificationssecretioncanisterforATMOSS201ThoraxCapacity Max. 2000 ml
Canister ATMOS disposable canister, transparent with integrated water lock, pressure control valve, classification acc. to DIN EN ISO 10079, max. capacity 2 l, connection to the device with plug and play system“, Material: PC Lexan 144R Resin
Suction hose ATMOS disposable suction hose for Thorax, double-lumen, with an integrated bacterial filter in the measuring channel, medical grade PVC (ModenPlast RB4 NDG), 180 cm long
Further component parts a) Pop-off-valve (silicone) b) Hydrophobic bacterial filter made of sintered PE
Weight 430 g
Dimensions HxWxD (max.) 214 x 280 x 96 mm (max. )
Packaging Canister is covered with a PE-bag, wrapped in a printed PET/PE-bag with Tyvek-strips, Label for the identification of contents
Packaging unit 10 single wrapped canisters in a brown box, separately defined with an imprinted ATMOS logo!
Sterilization In the VE described above on a palette with EO (Ethylenoxid)
Ambient conditionsTransport/storage
-20...+50°C5...95 %humidity without condensation by an air pressure of 700...1060 hPa
ATMOS REF: 312.1150.0
Marking on the canisterCE-mark on the packaging For single use Pay attention to the package information leaflet
Classification acc. to annex IXEG-Guidelines 93/42/EWG Is
GMDN CodeUMDNS Code
3777015-270
2
25
9.0 Technicalspecifications
Issue of Technical Specifications: 15.08.2011 * 1 bar ≈ 750,06 mm Hg ≈ 1000 hPa / depends on daily atmospheric pressure
Voltage 100 – 240 V~, 50/60 Hz
Power input max. 70 VA
Fuse 1 x T 1 A, type L
Built-in rechargeable battery 21.6 V, at least 2250 mAh, lithium-ionic cells
Further connection options to the nurse call system, by potential free switching contact
Other safety lugs Pressure control valvel „pop off“ in the containerVacuum limitation in the device to approx. 150 mbarAcoustic and optical error warnings
Pump performance Free flow 16 l/min +/- 4 l/minVacuum adjustable from 5 to 100 mbar, step size 1mbar
Display, backlit Graphic display with readout of target vacuum and actual vacuum in mbar or kPa, current flow in l/min, various symbols and setting menus, language to be selected: German, English, French, Italian, Spanish
Data memory Memory for continuous recording of the flow values from the past 12 days.
Container ATMOS single-use container, translucent, with integrated water lock, pressure control valve, graduation, max. filling level 2l, conection to the device via direct docking, material: polycarbonate
Suction hose ATMOS single-use suction container for Thorax, double lumen, with integrated bacterial filter in the measuring channel, 180 cm length
Operating time Continuous operation, within the stated temperature range
Battery operation time at maximum continuous suction 1 h
Battery operation time at standard operation (without fistula) 12 h
Battery recharging time Fully recharge (at least 95 %) in approx. 2,5 h
Earth leakage current max. 0,5 mA
Patient leakage current max. 0,01 mA
Ambient conditions Transport/storage
Operation
-10...+50°C30...95 % air humidity without condensation at air pressure 500...1060 hPa
+10...+35°C30...95 % air humidity without condensation at air pressure 700...1060 hPa
Dimensions HxWxD approx. 365 x 250 x 168 mm
Weight 3.6 kg device with container
Material of housing ABS/PC UL 94 V0, grey-white and dove-blue
Noise level 39 dBA during standard operation
Regular safety-related controls A safety-related control must be performed every year. ATMOS recommends a yearly maintenance.
Protection class (EN 60601-1) II, protective earth conductor only for EMC protection
Application parts type CF, defibrillator-proof,recovery time: 10 sec
Degree of protection IP X0
Classification acc. to Appendix IX EC Directive 93/42/EEC
II a
CE marking CE 0124
Applied standardsEN 60 601-1EN 60601-1-2EN ISO 10079-1
UMDNS code 10-218, suction device, thoracic
GMDN code 36787
Ident No. 312.1000.0, ATMOS S 201 Thorax
26
10.3 Disposal
●The ATMOS S 201 Thorax 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).
Disposal within the EC
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 obser-ve existing national laws and rules for disposal of old devices.
Disposal within the Federal Republic of Germany
In the Federal Republic of Germany the law for electrical devices (ElektroG) rules the disposal of electrical devices. It must be assu-med 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 containers and hoses must be removed. The device surface must be disinfected.
10.0 Checking / Reprocessing / Disposal
10.1 Checking ATMOS suction devices
For the ATMOS S 201 Thorax the calibration should be checked once a year and a safety-relevant check should be performed acc. to § 6 MPBetreibV.
Depending on the number of recharging cycles of the batteries we recommend in this connection their exchange.
Regular, thoroughly cleaning and disinfection of the application parts respectively the operation in line with the operating instructions are assumed.
10.2 Reprocessing
In case secretion or any other liquids penetrated the device it must be reprocessed in order to protect patient and user. For hygienic reasons ATMOS recommends a yearly reprocessing. This reprocessing may only be perfor-med by ATMOS or an authorised specialist.
ATMOS MedizinTechnik GmbH & Co. KG offers their partners and customers a trouble-free and quick reproces-sing and checking / safety-relevant control for ATMOS suction devices.
27
11.0 Notes on EMC
11.1 Guidelines and Manufacturer´s Declaration - EmissionsThe ATMOS S 201 Thorax is intended for use in the electromagnetic environment specified below. The customer or user of the ATMOS S 201 Thorax should ensure that it is used in such an environment.
■ Medical electrical equipment is subject to special precautions with regard to EMC and must be installed acc. 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.
Emissions Test Compliance Electromagnetic Environment - GuidanceRF Emissions CISPR 11
Group 1 The ATMOS S 201 Thorax uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF Emissions CISPR 11
Class B The ATMOS S 201 Thorax is suitable for use in all establishments, including domestic, and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonics IEC 61000-3-2 Class AFlicker IEC 61000-3-3
match
11.2 Guidelines and Manufacturer´s Declaration - Immunity for ATMOS S 201 Thorax
The ATMOS S 201 Thorax is intended for use in the electromagnetic environment specified below. The customer or user of the ATMOS S 201 Thorax should ensure that it is used in such an environment.
Immunity Test IEC 60601-Test Level Compliance Level Electromagnetic Environ-
ment - GuidanceESD IEC 61000-4-2
± 6 kV Contact
± 8 kV Air
± 6 kV Contact
± 8 kV Air
Floors should be wood, concrete, or ceramics tile. If floors are syn-thetic, the relative humidity should be at least 30%.
EFTIEC 61000-4-4
± 2 kV Mains
± 1 kV I/Os
± 2 kV Mainsinapplicable± 1 kV I/Os
Mains power quality should be that of a typical commercial or hospital environment.
SurgesIEC 61000-4-5
± 1 kV Differential± 2 kV Common
± 1 kV Differential± 2 kV Common
Mains power quality should be that of a typical commercial or hospital environment.
Power Frequency 50/60 HzMagnetic field IEC 61000-4-8
3 A/m applicable 3 A/m
Power frequency magnetic fields should be that of a typical com-mercial or hospital environment.
28
Immunity Test IEC 60601-Test Level Compliance Level Electromagnetic Environ-
ment - GuidanceVoltage Dips / DropoutIEC 61000-4-11
< 5 % UT (> 95 % Dip of the UT) for 0.5 Cycle
40 % UT(60% Dip of the UT) for 5 Cycles
70% UT(30 % Dip of the UT) for 25 Cycles
< 5 % UT (>95 % Dip of the UT) for 5 s
< 5 % UT (> 95 % Dip of the UT) for 0.5 Cycle
40 % UT(60% Dip of the UT) for 5 Cycles
70% UT(30 % Dip of the UT) for 25 Cycles
< 5 % UT (>95 % Dip of the UT) for 5 s
Mains power quality should be that of a typical commercial or hospital environment. If the user of the ATMOS S 201 Thorax demands continued function even in case of interruptions of the energy supply, it is recommended to supply the ATMOS S 201 Thorax from an uninterruptible current supply or a battery.
NOTE UT is the mains alternating current prior to application of the test levels.
11.0 Notes on EMC
11.3 Guidelines and Manufacturer´s Declaration - Immunity The ATMOS S 201 Thorax is intended for use in the electromagnetic environment specified below. The customer or user of the ATMOS S 201 Thorax should ensure that it is used in such an environment.
Immunity Test IEC 60601-Test Level Compliance Level Electromagnetic Environment -
GuidancePortable and mobile communications equipment should be separated from the ATMOS S 201 Thorax incl. the cables by no less than the distances calculated/listed below.
Recommended distances:d = [ 3,5 / V1] √P
d = [ 3,5 / E1 ] √P80 MHz to 800 MHz
d = [ 7,0 / E1 ] √P800 MHz to 2500 MHz
where „P“ is the max. power in watts (W) and D is the recommended separation distance in meters (m).
Field strengths from fixed transmitters, as determined by an electromagnetic site (a) survey, should be less than the compli-ance level (b). Interference may occur in the vicinity of equipment containing following symbol.
Conducted RFIEC 61000-4-6
V1 = 3 Veff150 kHz to 80 MHz 3 V
Radiated RFIEC 61000-4-3
E1 = 3 V/m80 MHz to 2,5 GHz
3 V/m
29
11.0 Notes on EMC
11.4 Recommended separations between portable and mobile RF Communications equipment and the ATMOS S 201 Thorax
Recommended separations between portable and mobile RF Communicationsequipment and the ATMOS S 201 Thorax
The ATMOS S 201 Thorax is intended for use in electromagnetic environment in which radiated disturbances are controlled. The customer or user of the ATMOS S 201 Thorax can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications equipment and the ATMOS S 201 Thorax as recommended below, according to the maximum output power of the communications equipment.
Separation distance, depending on transmit-frequency mNominal output of the
transmitter
W
150 kHz to 80 MHz
d = [ 3,5 / 3] √P
80 MHz to 800 MHz
d = [ 3,5 / 3] √P
800 MHz to 2,5 GHz
d = [ 7,0 / 3] √P
0.01 0.12 0.12 0.2330.1 0.37 0.37 0.741 1.16 1.16 2.33
10 3.69 3.69 7.38100 11.66 11.66 23.33
For transmitters for which the maximum nominal output is not indicated in the above table, the recommended separation distance d in meters (m) can be determined using the equation belonging to the respective column whereas P is the maximum nominal output of the transmitter in watts (W) acc. to manufacturer´s specification.
NOTE 1 With 80 MHz and 800 MHz the higher frequency range applies.
NOTE 2 These guidelines might not be applicable in any case. The propagation of electromagnetic sizes is influenced by absorptions and reflections of buildings, objects and people.
NOTE 1 With 80 MHz and 800 MHz the higher frequency range applies.
NOTE 2 These guidelines might not 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 S 201 Thorax is used exceeds the above compliance level, the ATMOS S 201 Thorax 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.
30
For your notes
31
For your notes
MedizinTechnik
This document is copyrighted. Duplication, translations, microfilming and savings on electronic systems, particularly for commercialpurposesare illegal without prior agreement of the manufacturer. All compiled data are based on manufacturers instructions. All logos,product names and designations used in this document are property of the respective manufacturer.We do not take over any warranty and liability in the case of missing inscriptions. Subject to modifications and amendments.
1. General:Our General Standard Terms and Conditions apply exclusively. Client’s terms and conditions which are contrary to or deviate from our General Standard Terms and Conditions are not recognised unless their validity is explicitly confirmed in writing. Our General Standard Terms and Conditions also apply even if we deliver to clients without reservation, in the knowledge of the client’s contrary terms and conditions. Our General Standard Terms and Conditions also apply to all future business with that client.
2. Proposal - Order Confirmation Our proposals are subject to change without notice unless otherwise stated in our order confirmation. Each order is only accepted by us following our written order confirmation.
3. Orders Every order requires an exact description of all of our product’s details. We assume no liability for errors and damage caused by inaccurate or incomplete ordering details.
4. Prices Unless otherwise stated in the order confirmation, our prices in the order confirmation are ex factory prices and exclude packaging and value added tax. Packaging is charged separately at cost price in the invoice. Value added tax is charged separately in the invoice according to the legal rate on the invoice date. We reserve the right to change prices appropriately should price reductions or increases, especially due to wage settlements, changes in the price of materials or currency fluctuations, be incurred. Proof of such changes will be provided for the client on request.
5. Payment Conditions - Balancing Unless otherwise stated in the order confirmation, our invoices are payable with a 3% discount within 10 days (except for repair and assembly services) or within 21 days from the invoice date net cash; money receipts is decisive for complying with this term. We are entitled to charge interest after the due date at a rate 2% above the relevant basic interest rate of the German Federal Bank. Should the client have payment arrears, we are entitled to charge interest on arrears at a rate 5% above the relevant basic interest rate of the German Federal Bank. Should we be able to prove higher damages due to arrears, we are also entitled to claim these. The client only has the right to balance invoices against its own claims should such claims be confirmed in a court of law or recognised by us. The client does not have the right of retention due to disputed counterclaims.
6. Delivery Periods Fulfilment of our delivery duties requires the punctual and proper fulfilment of the client’s duties. The right to defense on the grounds of an unfulfilled contract is reserved.Should the client default in accepting the goods delivery or breach other cooperation duties, we are entitled either to withdraw from the contract or claim compensation for any increased costs incurred up to that time without setting a further deadline. The right to make further claims is reserved. Furthermore, in such cases, the risk of coin-cidental destruction or a coincidental deterioration in the quality of the delivered goods is transferred to the client in the case of default in accepting such goods or payment arrears. Acts of God or stoppages (due to insufficient supplies of material, industrial disputes etc.) entitle us either to demand an appropriate extension of delivery periods or to partly or entirely dissolve the delivery contract. This does not give the client the right to claim damages. We have fulfilled delivery periods if the delivery goods have left our factory or the client has been informed of the goods’ readiness for delivery within such delivery periods. Delivery periods stipulated by the client are not recognisedby us unless they form part of our order confirmation. We adhere to legal terms and conditions in cases where, as a result of an undue delay in the delivery for which we are liable, the client is entitled to claim that his interests in a continued fulfilment of the contract have ceased. We also adhere to legal terms and conditions should a delay in delivery be caused by deliberate or grossly negligent action by us or our representatives for which we are responsible. We are also responsible for such actions by our representatives or agents. Should the delivery delay not be caused by our deliberate infringement of contractual duties for which we are responsible, our liability is limited to damage which is regarded as typical for that case. We are liable according to the legal terms and conditions if and in so far as the delivery delay for which we are responsible is caused by an infringement of a substantial contractual duty. In such cases, our liability is also limited to damage which is regardedas typical for that
case. Should the delivery delay be caused by a culpable infringement of non-substantial contractual duties, our client is also entitled to claim a one-off damage compen-sation worth 3 percentage points of the delivery value of the goods for each week’s delay, up to a maximum which is no higher than 15 percentage points of the delivery value of the goods
7. Delivery - Familiarisation In the case of the delivery of devices for the medico-technical industry which require assembly and/or familiarisation for the final customer using specialist trade personnel (such as Ear, Nose and Throat Apparatus and Suction Units), we reserve the right to deliver the goods exclusively to the relevant specialist traders. Should the trader not carry out assembly and/or familiarisation for the final customer, this is carried out by us. In such cases, we reserve the right to charge the client for the additionally created costs. Our specialist traders operate a recording system so that, if necessary, our products can be traced to the final customer. The specialist trader undertakes to immediately report to us all events and risks which must be reported in connection with our products.
8. Passage of Risk - Packaging Unless otherwise stated in our order confirmation, delivery is agreed ex factory. The risk of the goods’ damage or loss is therefore transferred to the client as soon as the goods leave the factory or the client is in default of acceptance of the goods. This also applies to cases where we confirm prepaid carriage. Transport packaging and all other packaging according to the packaging regulations is not returnable. Our client is responsible for disposing the packaging at its own cost. Our deliveries are insured by us at the client’s expense unless explicitly otherwise agreed. No insurance is arranged in the case of goods which are collected by our clients. In the case of transport damage, claims are only handled if the client receives confirmation of any damage, reduced weight or loss by the shipping company before accepting the delivery.
9. Warranty The client is responsible for examining the delivered goods immediately after receiving them to determine any eventual deficiencies or delivery errors, and to report these immediately. Should the client fulfil this examining and reporting responsibility, and should payment conditions be fulfilled, we shall be liable to the client within the scope of legal regulations. Our period of warranty shall in all cases be two years. Our client can make use of the warranty as follows, so long as he can provide first buyer proof (in the form of an invoice or delivery note) and provided that the product still has the original, unchanged serial number: a. We choose whether to fulfil our guarantee by providing repair
services free of charge - either on the client’s premises or in our factory - or replacing the product. We can also provide these guarantee services through an authorised company;
b. Should a product be returned to us, the client agrees to send the product in its original or similar packaging, offering the same protection as the original packaging, to our address or any address notified by us.
c. Our guarantee ceases to apply if changes of any kind have been made to our product, unless such changes have been made by us or a company authorised by us, or have been previously agreed upon in writing by us. Our guarantee also ceases to apply if third parties have carried out repairs to our products or replaced parts thereof. This applies regardless of the fact whether these measures individually or collectively led to a deficiency of the product;
d. We accept no responsibility for damage defects caused by - operational wear and tear; - incorrect installation or incorrect or insufficient maintenance; - incorrect operation of the product (in contradiction to the operating instructions delivered with the product); - improper use or operating faults; - inappropriate or negligent handling and care, especially with respect to dirt, lime, suction of fluids, inappropriate cleaning and sterilisation;
- using accessories and/or replacementpartswhich are not explicitly approved; - incorrect assembly and/or initial operation by the client or third parties; - the client’s negligence in handling the product; - unacceptable operating conditions, such as humidity, temperatures, the power supply, vibrations. - accidents, acts of God, especially lightening, water, fire, public unrest and insufficient ventilation. We are not liable for damage to other objects apart from our product itself, except in thecase of any deliberate or grossly negligent actions by us or our representatives or agents. Should no deliberate breach of contract be claimed, our liability
is limited to damage which is regarded as typical for tthat case. This also applies in the case of our culpable infringement of substantial contractual duties The indispensable conditions of German Liability Law remain unaffected thereby. - For second-hand equipment, the period of warranty shall be reduced to a period of twelve months.
10. Reservation of Ownership We retain ownership of our goods until the receipt of all payments arising from the business relationship, including all demands arisingfrom installation orders, subsequent orders, repairs, accessory deliveries and replacement orders. Should we have agreed upon payment on the basis of cheque and bill transactions, the ownership reservation applies until the cheque received byus has been paid in, and does not expire through our credit upon receiving the client’s cheque. In the case of a breach of contract by the client, especially payment arrears, we are entitled to repossess our goods. Repossession of our goods repre-sents a withdrawal from the contract, unless explicitly declared in writing by us. We have the right to utilise the product after its repossession, whilst the income form such use is balanced against the client’s arrears, after deducting appropriate utilisation costs.The client is responsible for handling the goods with care. Should maintenance and inspection work be necessary, the client must carry these out punctually at his own cost. Our client is entitled to sell the goods he has bought from us in a proper sale transaction. However, he must immediately assign all outstanding claims to the value of the final invoice sum (including value added tax) of our claims to his customers or third parties. The client is entitled to collect this claim even after such assignment. Our right to collect the claim ourselves remains unaffected thereby.We undertake to release the securities to which we are entitled if requested to do so by the client should the realisable value of the our securities be more than 10 percentage points higher than the outstanding claims. We reserve the right to choose the securities to be released.
11. Plans and Illustrations We retain ownership of and copyrights to all plans, illustrations, calculations and other documents which are attached to our proposals. The client must receive explicit written permission before passing these on to third parties. Imitating our legally patented products is forbidden and will be prosecuted.
12. Jurisdiction and Place of Performance Our central office is the place of performance for all disputes in connection with these General Standard Terms and Conditions and the contracts closed with clients under them. This jurisdiction excludes other jurisdiction relating to persons or subject-matter. Furthermore, our client is not entitled to bring charges against us in another court should he file counter-charges, carry out counterbalancing or declare retention. We, however, are entitled to bring charges against our client at their general place of jurisdiction or at another relevant court recognised by German or foreign law.Unless otherwise stated in the order confirmation, our central office is the place of performance.
Lenzkirch, September 2008ATMOS MedizinTechnik GmbH & Co. KG79853 Lenzkirch/Germany
ATMOS General terms and conditions
