Operating instructions

English

316.0000.B 2013-06 Index: 19

ATMOS® S 042 NPWT

Table of contents 1.0 1.1 1.2 1.3 1.4 1.5 1.6

Introduction ............................................................... 3-4 Notes on operating instructions...................................... 3 Intended purpose (indication)......................................... 3 Function ......................................................................... 3 Explanation of symbols .................................................. 4 Scope of supply.............................................................. 4 Transport and storage .................................................... 4

2.0 2.1 2.2

For your Safety .......................................................... 5-6 Contraindications ........................................................... 6 Special precautionary measures .................................... 6

3.0 3.1 3.2 3.3 3.3.1 3.3.2 3.3.3 3.3.4

Presentation ........................................................... 7-12 Device overview ............................................................. 7 Buttons and symbols ...................................................... 8 Prepare and assemble vacuum unit............................... 9 Charge battery ............................................................... 9 Connection and removal of shoulder and hip belt .......... 9 Attachment and removal of secretion canister ............. 10 Connecting/removing the vacuum unit with the wound dressing set ................................................. 10-11 Attachment of stand holder ...........................................11 Attachment/removing the vacuum unit at/from the stand holder ................................................................. 12

3.3.5 3.3.6 4.0 4.1 4.1.1 4.1.2 4.1.3 4.1.4 4.1.5 4.1.6 4.1.7 4.1.8 4.1.9 4.2 4.2.1 4.2.2 4.2.3 4.2.4 4.2.5 4.2.6 4.2.7

Operating ............................................................... 13-16 Basic functions ............................................................. 13 Switch on/off vacuum unit Set negative vacuum pressure..................................... 13 Start/interrupt therapy .................................................. 13 Switch on/off intermittence ........................................... 13 Key lock....................................................................... 14 Language selection ...................................................... 14 Factory settings ............................................................ 14 Brightness .................................................................... 15 Day / Night mode ........................................................ 15 Warning messages....................................................... 16 Battery empty ............................................................... 16 Tube clogged................................................................ 16 Canister full .................................................................. 16 Leakage ....................................................................... 16 Battery liftime exceeded ............................................... 17 Automatoc turning off ................................................... 17 Safety-related check .................................................... 17

Further information, accessories, consumables and spare parts are available from:

ATMOS

MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Straße 16 79853 Lenzkirch Germany Phone +49 7653 689-0 Fax +49 7653 689-190 +49 7653 689-292 (Service Centre) [email protected] www.atmosmed.com 2

5.0 5.1 5.2 5.3 5.4 5.5

Cleaning and care ................................................. 18-19 General information on cleaning and disinfection ........ 18 Cleaning the device surface ......................................... 18 Cleaning the shoulder and hip belt............................... 18 Recommended disinfectants for surfaces .................... 19 Hygiene plan ................................................................ 19

6.0 6.1 6.2 6.3

Maintenance and services......................................... 20 Basic information.......................................................... 20 Repairs ......................................................................... 20 Handling of rechargeable batteries .............................. 20

7.0

Trouble-shooting ........................................................ 21

8.0 8.1 8.2 8.3

Accessories, consumables and spare parts ........... 21 Accessories .................................................................. 21 Consumables ............................................................... 21 Spare parts................................................................... 21

9.0

Technical specifications ............................................ 22

10.0

Disposal ...................................................................... 23

11.0

Notes on EMC ........................................................ 24-26

12.0

Declaration of conformity.......................................... 27 General terms and conditions

1.0

Introduction

1.1 Notes on operating instructions These operating instructions contain important notes on how to operate the ATMOS® S 042 NPWT safely, correctly and effectively. Their reading helps to avoid risks, and also to reduce repair costs and down-time. That increases, amongst other things, the reliability and service-life of the device. These operating instructions serve not only for new operating personnel to be instructed in its use, but also for use as a reference manual. Full or partial reproduction is subject to prior written approval from ATMOS. These operating instructions must always be kept available near the device. Care and safety inspections in conjunction with professional execution provide for operational safety and readiness for use of your ATMOS® S 042 NPWT and are therefore a must besides regular cleaning. Repair work and safety inspections may be carried out only by expert personnel authorised by ATMOS. By applying only original spare parts you will have the guarantee that operational safety, readiness for work and the value of your ATMOS® S 042 NPWT will be preserved.

● The product ATMOS® S 042 NPWT bears CE marking CE 0124 according to the EC Directive of the council for medical products 93/42/EEC and meets the basic requirements of annex I of this Directive. ● The quality management system applied at ATMOS has been certified 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.

1.2 Intended purpose (indication) Main function: Generation of a controlled negative pressure on an acute or chronic wound. Med. Indication/ application: For application on humans. Specification of the main function: As a result of the generated controlled negative pressure wound secretion and infected materials are transported from the wound via a wound dressing with a connecting hose system and is then collected in a secretion canister. Due to the negative pressure the cell growth and the blood flow are encouraged. Application organ: Chronic and acute wounds on the skin which do not close by primary wound healing. Duration of application: Under normal circumstances a continuous application over a period of more than 30 days. Application environment: Suitable for application in clinics, medical fields and home enviroment. The application of the negative pressure device may only be conducted under physicians instructed and by medical expert staff.

Contraindications: Contraindications exist by patients with malignant tumor wounds (non enteric fistulas) which hane not yet been examined, osteomyelitis or necrotic tissue. The ATMOS S 042 NPWT must not be applied to exposed nerves, anastomis areas, blood vessels or organs. The vacuum unit must not be used: - for non-medical applications - in the presence of flammable or explosive gases or liquids The system is not evaluated for the emergency medicine in the rescue area (rescue vehicle, accident location) This product is:

Active

Sterility:

canister system is sterile

Disposable product / reprocessing: Canisters are disposable products

1.3 Function The ATMOS® S 042 NPWT is a particularly convenient suction device for negative pressure wound therapy. The vacuum unit is operated by an electromotive maintenance-free membrane pump. During operation the pump creates a vacuum in the wound dressing, the tubing system and the secretion canister; this vacuum is used to suck secretions. The vacuum unit automatically creates, controls and monitors the set therapy values. The secretion is collected in the respectively provided secretion canister. A special filter technology prevents penetration of liquids, bacteria and odours into the device. Therapy settings can be made using the touch screen. The vacuum unit is equipped with a rechargeable lithium ionic battery. Safe recharging of the battery is ensured by a microprocessor-controlled electronic charge system located in the vacuum unit.

3

1.0

Introduction

1.4 Explanation of symbols Short cuts / symbols contained in this manual Follow the arrows whilst proceeding, sequence

■

General information

Please press where the dot indicates

●

Numeration

Please read, important information

→

Subnumeration

Move, plug ... in this direction Turn, shift ... in this direction Replace

Check

click

Engage, check correct fit

Pictures contained in this manual

!

Warning, special diligent notice!



The CE sign shows that this product meets the appropriate requirements of the EC Directives.

Symbols des ATMOS S 042 NPWT SN

Serial number

REF

Order number

Professional disposal

Important information

Please observe operating instructions! Type BF

Manufacturing date

Class II

1.5

Scope of supply

1.6

● Prior to dispatch, the ATMOS® S 042 NPWT 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).

Extents of supply

● 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.

vacuum device

mains cable (country-specific)

shoulder belt

operating instructions

battery recharger

4

● 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.

2.0

For your Safety

!

For your Safety ● The ATMOS® S 042 NPWT is designed in accordance with IEC 60601-1/EN 60601-1. It is a device which meets the VDE protection class II. It may only be connected to a properly installed earthed wall socket. ● Prior to putting into operation the device, mains cable, accessories and connecting cables have to be checked for any damage. Damaged cables have to be replaced immediately. ● Prior to use please check the secretion canister and the connecting tubes on any damage. Do not use damaged secretion canisters. ● The ATMOS® S 042 NPWT is not designed for operation within areas where there is a risk of explosion (M and G) and in oxygen rich enviroments. Areas that are at risk from explosions can arise due to the use of combustible anaesthetics, skin cleaning and skin disinfecting materials. ● No secretion may enter the device. If wound secretion 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 diaphragm of the unit might be damaged if it runs in this condition. ● Removal of the canister from the device during therapy should only by made by instructed personnel. ● The device should always be used in vertical position. ● Prior to start up the device, the user should verify correct functioning of the optical and acoustic display ● Prior to start up the device it should be checked whether the mains voltage and frequency correspond to the values stated on the device. ● Avoid the risk of the device falling to the floor. Following a fall an efficiency control must be conducted. Connect the device to the power supply and start the device. If an error message appears please contact the service. Otherwise the device may continue to be used.

● Dispose of the packing material in a proper manner. Please observe national regulations! ● Only medical, undamaged mains connection and extension cables must be used. ● 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. ● 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. ● Change of dressing: Please observe the respective instructions for use of the used wound dressing sets. ● The set negative pressure should never cause pain. If the patient states discomfort, you should consider a reduction of the negative pressure. ● Avoid the risk of dislocation or clogging of the tube by regularly checking the hosing system and its connections for leakages and kinks. ● Multiple use of components which are marked with a 2 is forbidden. In case of repeated use these components lose their function and there is a high infection risk. ● During operation, the user is obliged to regularly check the negative pressure unit for proper function. In the unlikely event of failure of the negative pressure unit, the user has to make arrangements to continue the treatment of patients with suitable methods.

● Disfectant should not enter the device. If disfectant has penetrated the device, then it must be dried thoroughly and subsequently an efficiency control must be conducted. If the desired target vacuum is reached then the device may continue to be used. If not, the device must undergo a service check before it resumes operation.

5

2.0

For your Safety

● The patient should not take a shower or have a bath when using the ATMOS® S 042 NPWT. Interruption of therapy for such purpose should only be made in consultation with the attending physician.

● Bone fragments or sharp edges may damage blood vessels or organs, and thus should be covered or removed before application of negative pressure wound therapy.

● Please regularly check the filling level of the secretion canister to ensure problem-free operation of the vacuum unit. If the maximum filling level is achieved, please replace the canister with a new secretion canister.

● Wounds with intestinal fistulas should only be treated with ATMOS® S 042 NPWT when observing special precautionary measures.

● Please observe all precautionary measures for infection control of patients and the care personnel generally applicable to you and your institution in order to reduce the risk of infections and transfer of pathogens. Please take corresponding protective measures (e.g. wearing of gloves, protective coat, face and eye protection) if contacting body liquids or handling contaminated parts. ● Continuous vacuum is recommended rather than intermittent vacuum with regard to instable structures, e.g. instable chest wall or injured fascia. This helps to reduce movement and stabilise the wound bed. Continuous vacuum treatment is generally recommended for patients with an increased risk of bleeding, exsudative or acute enteric fistula wounds and with fresh flaps/transplants.

2.1

Contraindications

This medicinal device is contraindicated for patients with malignant tumour wounds, non-enteric and not examined fistulas, osteomyelitis or necrotic tissue. The ATMOS® S 042 NPWT must not be used directly on exposed nerves, anastomosis areas, blood vessels, or organs. The vacuum unit must not be used: ● for non-medical applications ● in connection with easily inflammable or explosive gases and/or liquids

2.2

Special precautionary measures

● Special precautionary measures are indicated for patients with acute bleedings, coagulation disorders as well as for patients treated with anticoagulants. Here, the 800 ml secretion canister should not be used. In case of sudden or increased bleeding, treatment should be stopped immediately. In such a case the attending physician should be informed, and suitable haemostatic measures should be taken. ● Blood vessels and organs should be sufficiently protected by overlying fascias, tissue or other protective layers. Special precautionary measures should be taken in case of infected, weakened, irradiated or sutured blood vessels or organs.

6

● With movable parts of the body which cannot be immobilised, a continuous (but not intermittent) therapy is indicated to minimise irritations. ● Therapy should be stopped in the case of spinal injuries of the patient with development of an autonomic hyperreflexia. ● The ATMOS® S 042 NPWT was not evaluated for application in paediatrics. Before prescribing application with a child, please verify weight and height of the patient. ● The ATMOS® S 042 NPWT is not compatible with MRT (magnetic resonance tomography). Thus, do not operate the ATMOS® S 042 NPWT in the vicinity of an MRT. ● During operation, transport, repair, cleaning and disposal of the ATMOS S 042 NPWT or its accessories, reasonable general precautionary measures should be taken. Improper handling may result in the risk of inhalation of infectious substances or the risk of contamination to internal parts of the device. ● The vacuum unit must only be used by a physician or - upon medical request - by qualified and authorised personnel. The user should be correspondingly trained and should provide of knowledge in the field of special medical applications which the ATMOS® S 042 NPWT was designed for.

3.0 Presentation of the ATMOS S 042 NPWT 3.1

Device overview Rear:

Front:

6

10

7 5

7 8

1

4 3

2

    

9

Touch screen

    

On/Off button Charging plug connector Secretion canister (not included in the scope of delivery) Secretion canister releasing device

Secretion canister connections Carrying belt hinge Name plate Canister guide USB connector

Secretion canister:

11

12

11

Bacteria filter

12

Canister guide

7

3.0 Presentation of the ATMOS S 042 NPWT 3.2

Buttons and symbols

The ATMOS® S 042 NPWT is equipped with a touch screen. The whole operation is performed by touching the buttons displayed on the screen. Operation: The buttons on the screen always indicate what will happen after pressing the respective button. Attention! Any touch of the screen will be signalised with a sound. However, such button sound does not indicate that the selected button is activated.

!

Button

Symbol

Name

Function

On/Off button

When touching this button for two seconds the vacuum unit can be switched on and off.

Start button

Starts therapy.

Stop button

Stops therapy.

Menu button

For calling up submenus.

Plus button

For increasing the displayed values.

Minus button

For decreasing the displayed values.

Intermit button

For activation of the intermittent vacuum treatment. When activated it is green framed.

Continuous button

For activation of continuous vacuum treatment. When activated it is green framed.

Intermittent menu

Touch this button to access the intermittent menu. Here you can set the intermittent parameters for optimisation of therapy. When activated it is green framed.

Save/Back

With this button you save the set value and go back one menu level. Attention: If you do not want to save the set values, wait until the screen returns to the previous menu level.

Up

This button is used to scroll upwards in menus.

Down

This button is used to scroll downwards in menus.

Close

This button is used to close the warning window and to suppress the alert.

Definition Battery charging status. Key lock activated. Key lock deactivated. Leakage display. Shows leak tightness and/or leakage of the system using the colours green, yellow and red. (Only visible during therapy) Alert is suppressed. If the cause for the alert is remedied, the symbol will automatically disappear. USB stick connected.

8

3.0 Presentation of the ATMOS S 042 NPWT 3.3

3.3.2 Connection and removal of shoulder and hip belt

Prepare and assemble vacuum unit

4

3.3.1 Charge battery

!

Attention! The battery should be fully charged before first commissioning of the ATMOS® S 042 NPWT. Only the charger supplied by ATMOS should be used. The negative pressure unit should be recharged in a cool place without any direct solar radiation. Recharging period is prolonged if the ambient temperature is >25°C. Improper use of the device may lead to serious damage. The guarantee does not cover any damage due to improper handling.

● Connect the charging plug of the charger to the charging connector  of the vacuum unit.

3

1

2 5

    

Snap link for attachment to the negative pressure unit Snap link for attachment to the negative pressure unit Snap link for attachment to the negative pressure unit Strap closure for attachment to the bed Strap closure for attachment to the bed

Attaching the shoulder strap

● Take the strap end  and hook it to one of the

attachment loops on your negative pressure unit.

● Now hook the other strap end  to the second ● Connect the charger with the supplied countryspecific power cord.

attachment loop on your negative pressure unit.

Attaching the negative pressure unit to patient’s bed

● To prepare attachment to a patient’s bed hook the snap link  instead of snap link to the device..

● Now you only need to connect the strap ends  and ● Connect the mains plug to the mains outlet. The vacuum unit then displays the moving symbol on the screen.

 to each other, to attach the negative pressure unit to a patient’s bed.

● When the battery is fully charged (the symbol does not move any more ) , disconnect the mains plug from the mains outlet.

● Disconnect the charging plug from the charging connection of the vacuum unit.

Information: If the charging status of the battery is low, then the vacuum unit will raise an alarm and the screen with display a warning window (see chapter Warning messages). If the battery is too weak for further operation, the vacuum unit will automatically switch off.

Unlocking the negative pressure unit for removal

● Press the unlocking device of the strap closure laterally and keep it pressed.

● Now pull the two ends apart. ● To make it ready for shoulder attachment hook the snap link  to the device.

9

3.0 Presentation of the ATMOS S 042 NPWT 3.3.3 Attachment and removal of secretion canister

!

Attention! The secretion canisters of your vacuum unit are sterile units which can be used in sterile surgery environments. Please observe the respective operating instructions of the secretion canisters. Attachment of secretion canister: peel packaging. Ensure that the attached tube does not fall onto unsterile ground.

● Now place the canister - with a slight incline 13

.

14

13

● Tilt the secretion canister into the direction of the vacuum unit until it clicks into place

14

.

● Perform a slight tension test at the secretion canister to ensure that it is tightly fitted to the device.

Removal of secretion canister:

● Remove the secretion canister as described in the

chapter „Connecting/removing the vacuum unit with the wound dressing set“.

● Press the unlocking button at your vacuum unit and remove the secretion canister in a slightly inclined position.

● Properly dispose of the secretion canister.

10

!

Attention! The ATMOS vacuum system provides of a double lumen suction tubing system to prevent blocking of the suction tube. Ensure that the connections are always correctly connected in order to avoid faults.

Connecting:

● Carefully remove the sterile secretion canister from the

into the guide pins of the device

3.3.4 Connecting/removing the vacuum unit with the wound dressing set

● Connect the tube ends of the container and the wound dressing kit with each other.

3.0 Presentation of the ATMOS S 042 NPWT Removal:

● Pull the fixing pin from the fixing at the bottom side of the stand holder.

● Press the lateral unlocking button of the tube connector and keep the button pressed.

● Turn the holder clamp until the fixing pin clicks into place at the next fixing.

● Pull apart both ends.

!

● The tube may not be clamped. Please do not use

Attention! Ensure that the fixing pin correctly clicked into place before attaching the vacuum unit on top.

Attaching the holder clamp:

any clamps.

● Turn the turning knob of the holder clamp clockwise

until the clamp can be attached to the desired fixture.

3.3.5 Attachment of stand holder (accessory part) Turning of holder clamp: The stand holder may be attached – horizontally and vertically - to plates (e.g. table boards), pipes and stands with a diameter up to 40 mm.

● Turn the turning knob clockwise to fix the holder clamp.

!

Attention! Ensure that the stand holder is firmly attached to the desired fixture.

11

3.0

Presentation of the ATMOS S 042 NPWT

3.3.6 Attaching/removing the vacuum unit at/from the stand holder

!

Attention! Firmly hold the vacuum unit during the whole process.

● Place the vacuum unit onto the stand holder. Ensure that the thread at the bottom of the vacuum unit is directly above the fixing screw of the stand holder.

● Turn the fixing screw counter-clockwise to fix the vacuum unit.

Removal of the vacuum unit is performed in reversed order.

12

4.0 4.1

Operation

Basic functions

4.1.1 Switching the negative pressure unit on and off How to switch on the negative pressure unit:

● Touch the key

for two seconds.

● When used for the first time the language selection

menu appears. Select the desired language here by touching the screen. A tick appears next to the selected language.

● Confirm your entry with

4.1.4 Switching the intermittent mode on and off With your negative pressure unit, you have the option of selecting between continuous and intermittent mode. In contrast to the continuous mode, which operates with a negative pressure that remains the same, the intermittent mode allows therapy with changing pressure intervals. Switching the intermittent mode on: To switch on the intermittent mode press the key. The key appears on the screen. This key indicates the set values of the intermittent mode and is framed in green.

in order to return to the

main screen.

To switch the negative pressure unit off repeat step 1.

4.1.2 Setting the negative pressure On initial delivery, the ATMOS S 042 NPWT is preset to a negative pressure of 125 mmHg. By touching the key, you can increase the negative pressure in steps of 5 mmHg. To reduce the negative pressure, touch the key. ®

Change values: To adapt the preset values touch the You reach the intermittent menu.

key.

How to adjust the preset values:

●

4.1.3 Starting/interrupting the therapy

!

Attention! Before starting the therapy, ensure that everything is properly connected and that all the therapy parameters have been set.

● To start therapy, touch the

key. The negative pressure unit starts to generate the set negative pressure.

● To interrupt or to finish therapy, touch the

!

key.

Touch the value you would like to change with a finger. The respective field is marked in dark blue.

● Now touch the

or

key to set the desired value.

● To save the newly set values touch the

!

key.

Attention! The values are only saved if the intermittent menu is closed with the key. If you do not wish to accept the values, you have set, wait until the screen automatically returns to the main menu, but do not touch the screen for this.

Attention! If the therapy is not started again the device switches itself off after 30 minutes (after Warning massages) .

13

4.0

Operation

4.1.5 Key lock

4.1.7 Factory settings

The ATMOS® S 042 NPWT has an automatic key lock. If no settings are undertaken on the screen over a period of one minute, the key lock is automatically activated in order to prevent accidental operation. If the device is switched to storage battery mode, the screen goes black after 5 minutes.

● Touch the

key to reach the submenu.

● Now select the field “Factory settings”. You will now be

asked whether you wish to return to the factory settings.

When the key lock is on, the screen goes black if the device is set to storage battery mode. How to unlock the key lock:

● The screen is activated by being briefly touched and the slide control for unlocking the key lock appears.

● Press “Yes“ to return to the factory settings. Press “No“ to cancel.

!

● Touch the slide control and drag it in the direction of the symbol.

4.1.6 Selecting the language Various languages can be set on the ATMOS® S 042 NPWT. Proceed as follows:

● Press the

key to reach the submenu.

● Now select the field “Language” to enter the language selection menu.

● Select the desired language now in the language

selection menu by touching the screen. A tick appears next to the selected language.

● To save the settings touch the 14

key.

Attention! The set language is not changed by returning to “Factory settings“.

4.0

Operation

4.1.8 Brightness

4.1.9

Your negative pressure unit automatically adjusts the brightness of the screen to match the prevailing brightness of the room. If the preset brightness does not meet your requirements, you can adjust the brightness as follows.

The negative pressure unit features a day / night mode. This means that it automatically reacts to match the prevailing brightness of the room.

● Touch the

key to reach the submenu.

● Now select the field “Brightness”. The field is marked in dark blue and the right hand side.

and

keys are shown on the

Day / Night mode

Storage battery mode: If the device is set to storage battery mode, the screen goes black after 5 minutes. If the brightness of the room is low, the background screen in the display becomes dark. Mains power mode: If the device is connected to the mains power and the room brightness is low, the background screen in the display becomes dark.

● Now set the desired value with the ● To save the settings touch the

!

and

keys.

key.

Attention! The screen reacts with a delay of two seconds.

15

4.0 4.2

Operation Warning messages

4.2.3 Container full

4.2.1 Storage battery low The warning window (picture “Storage battery low”) appears if the remaining operating time is less than one hour. Please connect the mains charger as soon as possible. By touching the key this warning message can be suppressed for 5 minutes and the therapy can be continued unhindered.

!

Attention! If the message is ignored, the negative pressure unit switches off automatically in order to protect the storage battery (see Chapter 4.2.6 “Automatic switching off”).

The following causes trigger the error message:

●

Container full: Change the exudate container.

●

Blockage of the bacteria filter in the canister: If the bacteria filter has become moist with exudate, it becomes blocked. Change the exudate container.

By touching the key this warning message can be suppressed for 5 minutes.

!

Attention! In order to prevent blockage of the filter make sure that the negative pressure unit is set up in stable position.

4.2.2 Tube blocked The error message (picture below) appears if the negative pressure unit detects a blockage in the container or tubing system

4.2.4 Leakage

This error message is triggered by leakage in the system which cannot be compensated for by the negative pressure unit. The following causes can trigger the error message:

● Kinks in the tubing system: Store the tube in such a way that no kinks can occur.

● Blockages at the connection points: Check all connection points for possible blockage and incorrect connections

!

16

By touching the key this warning message can be suppressed for 5 minutes. Attention! If the fault cannot be rectified by way of the above measures, the exudate container should be changed.

●

Check the wound dressing for any leakage.

●

Check all connections for leakage.

●

Check whether the container is firmly connected to the negative pressure unit.

By touching the key this warning message can be suppressed for 5 minutes. If it is not possible to rectify the leakage through these measures, it may be advisable to replace the wound dressing and the tubing system.

4.0

Operation

4.2.5 Storage battery service life exceeded

If the average lifetime of the battery is reached, this message will be displayed with every new start of the vacuum unit.

This warning message can be closed by touching the key and only appears again when the negative pressure unit is restarted. In order to avoid operational failure of the negative pressure unit have the storage battery replaced by the manufacturer as soon as possible

4.2.6 Automatic switching off If a mains charger has not been connected, in spite of repeated "Storage battery low" warning messages, the negative pressure unit switches itself off automatically

!

Attention! The negative pressure unit can only be switched on again once a mains charger has been connected, thereby recharging the storage battery.

4.2.7 Safety check A safety check is needed every two years. The following warning window appears if this condition is true.

This warning message can be closed by touching the key and only appears again when the negative pressure unit is restarted.

17

5.0

Cleaning and care

5.1 General information on cleaning and disinfection

!

The way the device is used determines its reliability and safety. These hygiene measures are indispensable for protecting the patient and the user and for maintaining a safe and reliable device.

!

Prior to cleaning please remove the mains cable, power supply and charging plug from the device.

!

The described measures for cleaning and disinfection do not replace valid rules for operating the device!

!

Plastic parts might get dyed by some disinfectants. Prevent liquids from penetrating the device.

!

Please observe the instructions for use prescribed by the manufacturers of disinfectants. Especially regarding concentration, their suitability for use and the contact time. 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.

!



Please always wear disposable gloves for any work you perform.



For disinfection all the surface disinfectants are suitable which are stated in chapter 5.4 „Recommended disinfectants“.



Prior to cleaning the device please remove and dispose all disposable parts like secretion canister, dressing and tubes.



The described measures for cleaning and disinfection do not replace on-site valid hygiene rules for operating the device!

 Basically all parts (secretion canister, tubes and dressing kits) must be disposed which come into contact with suction material when the device is used in another patient. We recommend you to document any maintenance work and also any exchange of parts.



5.2 Cleaning the device surface Prior to use the device in another patient the complete device surface must always be cleaned with a damp (not wet) cloth and disinfected with a surface disinfection solution. It is important that disinfectant does 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. Do not switch the device back on until the cleaning and disinfectants on the surface have dried completely. In case the device is used in one patient only the device surface should be cleaned if it is contaminated however at least once every week with a damp (not wet) cloth and afterwards be disinfected with a surface disinfectant.

!

Attention! The device may never be autoclaved, rinsed under running water or immersed into any liquids!

5.3 Cleaning the shoulder belt Prior to use the device in another patient the shoulder belt must be exchanged or hand washed at max. 40° C with soap sud (cleaning agent).

18

5.0 Cleaning and care 5.4 Recommended disinfectants for surfaces Disinfectant

Ingredients

ATMOS Green & Clean SK (application solution)

Alkyldimethylbenzylammoniumchloride 95 % Dip of the UT) for 0.5 Cycle

NOTE

Compliance Level < 5 % UT (> 95 % Dip of the UT) for 0.5 Cycle

40 % UT (60% Dip of the UT) for 5 Cycles

40 % UT (60% Dip of the UT) for 5 Cycles

70% UT (30 % Dip of the UT) for 25 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 5 s

Electromagnetic Environment - Guidance Mains power quality should be that of a typical commercial or hospital environment. If the user of the ATMOS® S 042 NPWT demands continued function even in case of interruptions of the energy supply, it is recommended to supply the ATMOS® S 042 NPWT from an uninterruptible current supply or a battery.

UT is the mains alternating current prior to application of the test levels.

11.3 Guidelines and Manufacturer´s Declaration - Immunity The ATMOS® S 042 NPWT is intended for use in the electromagnetic environment specified below. The customer or user of the ATMOS® S 042 NPWT should ensure that it is used in such an environment.

Immunity Test Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3

IEC 60601Test Level

Compliance Level

3 Veff 150 kHz to 80 MHz

3 Veff 150 kHz to 80 MHz 80% AM 1kHz

3 V/m 80 MHz to 2.5 GHz

3 V/m 80 MHz to 2.5 GHz

Electromagnetic Environment Guidance Portable and mobile communications equipment should be separated from the ATMOS® S 042 NPWT incl. the cables by no less than the distances calculated/listed below. Recommended distances: d = (3,5 / V1) * √(P) d = (3,5 / E1) * √(P) d = (7 / E1) * √(P)

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 compliance level (b). Interference may occur in the vicinity of equipment containing following symbol.

25

11.0 Notes on EMC NOTE 1

With 80 MHz and 800 MHz the higher frequency range applies.

NOTE 2

These guidelines may 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 042 NPWT is used exceeds the above compliance level, the ATMOS® S 042 NPWT 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.

11.4 Recommended separations between portable and mobile RF Communications equipment and the ATMOS® S 042 NPWT The ATMOS® S 042 NPWT is intended for use in electromagnetic environment in which radiated disturbances are controlled. The customer or user of the ATMOS® S 042 NPWT can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications equipment and the ATMOS® S 042 NPWT as recommended below, according to the maximum output power of the communications equipment.

Separation distance, depending on transmit-frequency m Nominal output of the transmitter

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

d = (3,5/V1) * √(P)

d = (3,5/E1) * √(P)

d = (7/E1) * √(P)

W 0.01

0.12

0.07

0.14

0.1

0.37

0.22

0.44

1.0

1.17

0.7

1.4

10

3.7

2.2

4.4

100

11.7

7

14

For transmitters for which the maximum nominal output isn´t 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 may not be applicable in any case. The propagation of electromagnetic sizes is influenced by absorptions and reflections of buildings, objects and people.

26

12.0 Declaration of conformity

27

ATMOS General terms and conditions

MedizinTechnik

1. General:

case. Should the delivery delay be caused by a culpable infringement

is limited to damage which is regarded as typical for tthat case. This

Our General Standard Terms and Conditions apply exclusively. Client’s

of non-substantial contractual duties, our client is also entitled to claim

also applies in the case of our culpable infringement of substantial

terms and conditions which are contrary to or deviate from our General

a one-off damage compen-sation worth 3 percentage points of the

contractual duties The indispensable conditions of German Liability

Standard Terms and Conditions are not recognised unless their validity

delivery value of the goods for each week’s delay, up to a maximum

Law remain unaffected thereby.

is explicitly confirmed in writing. Our General Standard Terms and

which is no higher than 15 percentage points of the delivery value of

Conditions also apply even if we deliver to clients without reservation,

the goods

- For second-hand equipment, the period of warranty shall be reduced to a period of twelve months.

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.

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

10. Reservation of Ownership We retain ownership of our goods until the receipt of all payments arising from the business relationship, including all demands arising

2. Proposal - Order Confirmation

specialist trade personnel (such as Ear, Nose and Throat Apparatus and

from installation orders, subsequent orders, repairs, accessory deliveries

Our proposals are subject to change without notice unless otherwise

Suction Units), we reserve the right to deliver the goods exclusively to

and replacement orders. Should we have agreed upon payment on the

stated in our order confirmation. Each order is only accepted by us

the relevant specialist traders. Should the trader not carry out assembly

basis of cheque and bill transactions, the ownership reservation applies

following our written order confirmation.

and/or familiarisation for the final customer, this is carried out by us. In

until the cheque received by us has been paid in, and does not expire

such cases, we reserve the right to charge the client for the additionally

through our credit upon receiving the client’s cheque. In the case of

3. Orders

created costs. Our specialist traders operate a recording system so

a breach of contract by the client, especially payment arrears, we are

Every order requires an exact description of all of our product’s details.

that, if necessary, our products can be traced to the final customer. The

entitled to repossess our goods. Repossession of our goods repre-sents

We assume no liability for errors and damage caused by inaccurate or

specialist trader undertakes to immediately report to us all events and

a withdrawal from the contract, unless explicitly declared in writing by

incomplete ordering details.

risks which must be reported in connection with our products.

us. We have the right to utilise the product after its repossession, whilst

4. Prices

8. Passage of Risk - Packaging

deducting appropriate utilisation costs.The client is responsible for

the income form such use is balanced against the client’s arrears, after Unless otherwise stated in the order confirmation, our prices in the

Unless otherwise stated in our order confirmation, delivery is agreed

order confirmation are ex factory prices and exclude packaging and

ex factory. The risk of the goods’ damage or loss is therefore transferred

be necessary, the client must carry these out punctually at his own cost.

value added tax. Packaging is charged separately at cost price in the

to the client as soon as the goods leave the factory or the client is in

Our client is entitled to sell the goods he has bought from us in a proper

handling the goods with care. Should maintenance and inspection work

invoice. Value added tax is charged separately in the invoice according

default of acceptance of the goods. This also applies to cases where we

sale transaction. However, he must immediately assign all outstanding

to the legal rate on the invoice date. We reserve the right to change

confirm prepaid carriage. Transport packaging and all other packaging

claims to the value of the final invoice sum (including value added tax)

prices appropriately should price reductions or increases, especially

according to the packaging regulations is not returnable. Our client is

of our claims to his customers or third parties. The client is entitled to

due to wage settlements, changes in the price of materials or currency

responsible for disposing the packaging at its own cost. Our deliveries are

collect this claim even after such assignment. Our right to collect the

fluctuations, be incurred. Proof of such changes will be provided for the

insured by us at the client’s expense unless explicitly otherwise agreed.

claim ourselves remains unaffected thereby.We undertake to release

client on request.

No insurance is arranged in the case of goods which are collected by

the securities to which we are entitled if requested to do so by the

our clients. In the case of transport damage, claims are only handled if

client should the realisable value of the our securities be more than 10

5. Payment Conditions - Balancing

the client receives confirmation of any damage, reduced weight or loss

percentage points higher than the outstanding claims. We reserve the

Unless otherwise stated in the order confirmation, our invoices

by the shipping company before accepting the delivery.

right to choose the securities to be released.

9. Warranty

11. Plans and Illustrations

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

The client is responsible for examining the delivered goods

We retain ownership of and copyrights to all plans, illustrations,

to charge interest after the due date at a rate 2% above the relevant

immediately after receiving them to determine any eventual deficiencies

calculations and other documents which are attached to our proposals.

basic interest rate of the German Federal Bank. Should the client have

or delivery errors, and to report these immediately. Should the client

The client must receive explicit written permission before passing these

payment arrears, we are entitled to charge interest on arrears at a rate

fulfil this examining and reporting responsibility, and should payment

on to third parties. Imitating our legally patented products is forbidden

5% above the relevant basic interest rate of the German Federal Bank.

conditions be fulfilled, we shall be liable to the client within the scope

and will be prosecuted.

Should we be able to prove higher damages due to arrears, we are also

of legal regulations. Our period of warranty shall in all cases be two

entitled to claim these. The client only has the right to balance invoices

years. Our client can make use of the warranty as follows, so long as

against its own claims should such claims be confirmed in a court of

he can provide first buyer proof (in the form of an invoice or delivery

Our central office is the place of performance for all disputes in

law or recognised by us. The client does not have the right of retention

note) and provided that the product still has the original, unchanged

connection with these General Standard Terms and Conditions and

due to disputed counterclaims.

serial number:

6. Delivery Periods Fulfilment of our delivery duties requires the punctual and proper

12. Jurisdiction and Place of Performance

the contracts closed with clients under them. This jurisdiction excludes

a. We choose whether to fulfil our guarantee by providing repair

other jurisdiction relating to persons or subject-matter. Furthermore, our

services free of charge - either on the client’s premises or in our factory

client is not entitled to bring charges against us in another court should

- or replacing the product. We can also provide these guarantee

he file counter-charges, carry out counterbalancing or declare retention.

fulfilment of the client’s duties. The right to defense on the grounds of an

services through an authorised company;

We, however, are entitled to bring charges against our client at their general place of jurisdiction or at another relevant court recognised by

unfulfilled contract is reserved.Should the client default in accepting the

b. Should a product be returned to us, the client agrees to send

goods delivery or breach other cooperation duties, we are entitled either

the product in its original or similar packaging, offering the same

German or foreign law.Unless otherwise stated in the order confirmation,

to withdraw from the contract or claim compensation for any increased

protection as the original packaging, to our address or any address

our central office is the place of performance.

costs incurred up to that time without setting a further deadline. The right

notified by us.

to make further claims is reserved. Furthermore, in such cases, the risk

c. Our guarantee ceases to apply if changes of any kind have been

of coin-cidental destruction or a coincidental deterioration in the quality

made to our product, unless such changes have been made by us

Lenzkirch, September 2008

of the delivered goods is transferred to the client in the case of default

or a company authorised by us, or have been previously agreed

ATMOS MedizinTechnik GmbH & Co. KG

in accepting such goods or payment arrears. Acts of God or stoppages

upon in writing by us. Our guarantee also ceases to apply if third

79853 Lenzkirch/Germany

(due to insufficient supplies of material, industrial disputes etc.) entitle

parties have carried out repairs to our products or replaced parts

us either to demand an appropriate extension of delivery periods or to

thereof. This applies regardless of the fact whether these measures

partly or entirely dissolve the delivery contract. This does not give the

individually or collectively led to a deficiency of the product;

client the right to claim damages. We have fulfilled delivery periods if the

d. We accept no responsibility for damage defects caused by

delivery goods have left our factory or the client has been informed of

- operational wear and tear;

the goods’ readiness for delivery within such delivery periods. Delivery

- incorrect installation or incorrect or insufficient maintenance;

periods stipulated by the client are not recognised by us unless they

- incorrect operation of the product (in contradiction to the operating instructions

form part of our order confirmation. We adhere to legal terms and

delivered with the product); - improper use or operating faults; -

conditions in cases where, as a result of an undue delay in the delivery

inappropriate or negligent handling and care, especially with respect

for which we are liable, the client is entitled to claim that his interests

to dirt, lime, suction of fluids, inappropriate cleaning and sterilisation;

in a continued fulfilment of the contract have ceased. We also adhere

- using accessories and/or replacement parts which are not explicitly

to legal terms and conditions should a delay in delivery be caused by

approved;

deliberate or grossly negligent action by us or our representatives for

- incorrect assembly and/or initial operation by the client or third

which we are responsible. We are also responsible for such actions by

parties; - the client’s negligence in handling the product; - unacceptable

our representatives or agents. Should the delivery delay not be caused

operating conditions, such as humidity, temperatures, the power supply,

by our deliberate infringement of contractual duties for which we are

vibrations.

responsible, our liability is limited to damage which is regarded as typical

- accidents, acts of God, especially lightening, water, fire, public

for that case. We are liable according to the legal terms and conditions if

unrest and insufficient ventilation. We are not liable for damage to

and in so far as the delivery delay for which we are responsible is caused

other objects apart from our product itself, except in the case of any

by an infringement of a substantial contractual duty. In such cases, our

deliberate or grossly negligent actions by us or our representatives or

liability is also limited to damage which is regarded as typical for that

agents. Should no deliberate breach of contract be claimed, our liability

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