ATMOS Atmoport N Operating Instructions Index 20 Aug 2014

Atmoport N

ATTENTION: Prior to starting the Atmoport N, please read these operating instructions carefully and keep them near the unit for later reference.

ATMOS MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Str. 16 – 79853 Lenzkirch / Germany – Tel: +(49)7653/689-0 – Fax: +(49)7653/689-190 – Fax: +(49)7653/689-393 (Service Center) – E-mail: atmos@atmosmed. de – Internet: http://www.atmosmed.de 2

1.0 Table of contents

1.0 2.0

Table of contents ... 3 General ... 4-8 2.1 Dispatch ... 4 2.2 Explanation of symbols ... 4 2.3 For your safety ... 5-6 2.4 Intended use ...7 2.5 Technical specifications... 8 3.0 Connecting, starting and operating the Atmoport N ... 9-13 3.1 Functioning... 9 3.2 Starting the unit ... 10 3.3 Operating the unit... 11-12 3.4 Operating modes... 12 3.5 Charging the battery...13 3.6 Electrical connections ...13 4.0 Cleaning and servicing ...14-17 4.1 Evacuating the collection canister ... 14 4.2 Cleaning the collection canister parts ...14 4.3 Cleaning and disinfection ... 14-15 4.4 Bacterial filter ...16-17 5.0 Trouble-shooting list ... 18 6.0 Spare parts and accessories ...19-20 7.0 Maintenance and repair ... 21-23 8.0 Disposal ... 23 9.0 Cleaning and servicing ... 24-25 10.0 Notes on EMC ... 26-31 General Standard Terms and Conditions

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2.0 General Prior to start-up please peruse chapter 2.0 „For your safety“, in order to be prepared for any possible dangerous situations. The product Atmoport N bears CE Marking CE-0124 according to the EEC guideline of the council for medical products 93/42/EEC and meets the basic requirements of this guideline. The product Atmoport N 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 certified according to international standards EN ISO 9001 and EN 13485. Reproduction of these instructions – even in part – only with the written permission of ATMOS.

2.1 Dispatch The Atmoport N was subjected to a thorough quality control before shipment. Carefully inspect the device immediately for any signs of damage and check the contents of the carton against the delivery note. In case of transport damages, please contact immediately the competent sender and carrier. Return shipment of the unit to the sender (e.g. for repair) is only to be effected in an undamaged shipping carton.

2.2 Explanation of symbols Symbol "Caution: pay attention to operating instructions" acc. to DIN 30600 1008, IEC 348 This symbol accentuates information relating to safety and refers to important details when applying the unit.

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Important information on use of this unit. Protection class II Degree of protection: type BF (body floating) Short-time operation

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2.0 General Charging of battery Connection to bacterial filter Charge battery External supply On / Off Contains Phthalates: Bis(2-erhylhexyl)phtalate (DEHP) The fingertip consists of PVC. Small amounts of the plasticiser DEHP may be released from the hose.

2.3 For your safety Only persons instructed in medical use may apply the Atmoport N to patients. Before connecting the charging power pack to the power supply, check whether the voltage stated on the data plate corresponds with the inbuilding voltage. Avoid moisture on plug and switches. The unit may not be started: – if cables or the charging power pack are defective, – if it has been dropped down before, – if obvious defects might restrict safe operation. In any case, have the unit checked by the service staff. Opening the interior of the unit for service work may only be effected by authorized service personal or technical specialists. Before opening the unit, dis-connect the charging power pack from the device. Only use original accessories and spare parts. ATMOS accepts no liability for damage to person or property if the Atmoport N is used contrary to the instructions for use. The Atmoport N may be operated only in rooms used for medical purposes, but not in areas subject to explosion hazards and in oxygen rich environments. 5

2.0 General Please note: A medical insulating transformer with earth leakage monitor or any similar safety system acc. to EN 60 601-1 is required, if several devices are connected over one common power supply. The transformer must correspond to the power consumption of all the devices to be connected. The Atmoport N has been designed for aspirating body fluids in medical ranges. Never remove explosive gases and inflammable or corrosive fluids. Disconnect the charging power pack: – before cleaning the unit, – before the collection canister is evacuated. Never pull at the cable of the charging power pack ! The unit may not be operated in splash water range, in high ambient temperatures and in locations where there is a danger of explosion (zones M and G). Never plunge the unit into water, not even when it is switched off. Only operate the unit in upright position and on a firm, level surface. Send unit only in padded shipping carton ! When operating the unit at ambient temperatures out-side the stated temperate range, the performance and operating period are reduced. Please note: A medical insulating transformer with earth leakage monitor or any similar safety system acc. to EN 60 601-1 is required, if several devices are connected over one common power supply. The transformer must correspond to the power consumption of all the devices to be connected. This product is not re-sterilisable. Repeated reuse of components which are marked with a 2 is forbidden. In case of repeated reuse these components lose their function and there is a high infection risk. The fingertip contains phthalates which are categorised as toxic for r production in category 2. This applies particularly to children, pregnant and breastfeeding women. As a preventive measure we recommend avoiding direct contact with the skin. The residual risk, which may arise through possible ex posure and due to the short term application, can be valued as insignificant compared to the benefit of the product.

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2.0 General 2.4 Intended use Name: Atmoport N Main functions: Temporarily and spontaneously suction of secretions, blood and body fluids and also liquid, viscous and solid pieces of food in the medical sector. For deflating of vacuum mattresses and inflatable splints. Med. indications/ application: Suction of the upper respiratory tract. Specification of the main function: Drainage and temporarily collection of body fluids. By means of an electrical suction pump, a negative pressure will be created. The integrated secretion canister allows a temporarily collection of the derived body fluids. Application organ: Upper respiratory tract (oral cavity, nasopharyngeal cavity and bronchial system). Application time: Temporary application on the patient (< 60 min.) Application site: The application site is the clinical, practices, emergency, nursing and home care sector. The application of the device may only be performed by medical trained and introduced staff. Contraindications: Not adapted for: • the continuous operation in case of drainages in the low vacuum range (e.g. thoracic drainage or wound drainage). • permanently endoscopic use. • the use outside of the medical sector. • the suction of flammable, corrosive and explosive substances. • the suction in explosion-risk areas. The product is:

X active

□ not active

Sterility: The device is not sterile. Single use product / reprocessing: The device and part of the accessories are reusable, for information on reprocessing and disinfection please see the operating instructions.

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2.0 General

2.5 Technical specifications Air flow rate of pump Max. vacuum at sea level Vacuum readout Additional air regulation Collection canister Suction hose Voltage ranges (charging power pack) Low voltage connection (charging power pack) Car connecting cable Current input (max.) Power consumption Battery, rechargeable Charging time of the battery, rechargeable Operation mode Operating time with battery Operating time with mains supply or low voltage connection Fuse (charging power pack) Protective earth conductor resistance Earth leakage current Enclosure leakage current Patient leakage current Heat emission Noise level Ambient conditionsTransport/storage Operation Dimensions HxBxT Weight Protection class (EN 60601-1) Degree of protection Protection category Protection class Classification acc. to Annex IXEEC directions 93/42/EEC CE marking Rules applied UMDNS-Code Reference-No. CanadianClassification Device Group PNC Risk class Description *1 bar @ 750,06 mm Hg @ 1000 hPa / depends on daily atmospheric pressure

Device Group PNC Risk Class Description

Ear, Nose and Throat 77QBW 2 ASPIRATOR, TRACHEAL

36 ± 2 l/min -79 kPa* (-790 mbar; -593 mmHg) -1...0 bar (± 25 mbar) (mm Hg; kPa)* mechanical regulating valve 1 l plastic ø 6 mm, 1.30 m length 100 V~ to 240 V~ 50/60 Hzwithout switching 12 V DC 12 V car mains 3.8 A 46 W 12 V, 2400 mAh, NiCd approx. 2 hours with 12 V DC Interrupted useCooling period: approx. 20 min. approx. 45 min. approx. 60 min. slow-blow 1 A/H for 250 V - - N.C. < 0.1 mA - 46 J/s 54.9 dB (A) @ 1m (acc. to ISO 7779) -30...+45°C20...80 % humidity, non-condensingair pressure 700...1060 hPa -5...+40°C20...80 % humidity, non-condensingair pressure 700...1060 hPa 262 x 288 282 x 106 mm approx. 3.8 kg II Type BF IPX 1 (drop water protection) I IIa CE 0124 EN 60601-1: 1990 +A1: 1993 + A2: 1995EN ISO 10079-1: 11/1996EN 60601-1-2: 1993 (EMV / EMC) EN 30993: 1994 15-016 Canadian Classification 312.0400.0 Ear, Nose and ThroatPNC 77QBW 2 ASPIRATOR, TRACHEAL

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3.0 Connecting, starting and operating the Atmoport N 1.5

1.1 1.2

1.6 1.7 1.8

1.3 1.4

1.9 1.10

Fig. 1a Atmoport N

1.1 Connecting hose 1.2 Bacterial filter 1.3 Attachment (for suction hose) 1.4 Collection canister 1.5 Hose attachment (on the unit) 1.6 Vacuumgauge 1.7 ON/OFF switch 1.8 Connection socket for power pack 1.9 Vacuum regulator 1.10 Battery pack

3.1 Functioning The Atmoport N is a very handy small suction unit. It is driven by an electromotive, maintenance-free diaphragm-type pump. During operation, the pump generates a vacuum within the tube system and the collection canister, thus sucking off secretions or fluids (e.g. by means of a suction catheter). The fluid is gathered in the collection canister. A mechanical overflow safety (on the inner part of the collection canister lid) avoids penetration of secretion into the pump head. The final vacuum and, following, the air-flow rate can be adjusted by means of the fine control and the vacuumgauge. The unit is equipped with a re-chargeable battery (accumulator). Integrated microprocessor-based technology assures safe charging of the battery; over-charging is thus impossible. An overtemperature stop controlled by electronics avoids overheating of the unit. A bacterial filter integrated in the lid of the collection canister prevents bacteria and liquid from penetrating into the pump. During the suction process a suction catheter or a medical approved suction instrument must always be used. The suction catheter is fixed in a suitable size for tracheal and nasopharyngeal suction at the end of the fingertip. For effective suction of viscous and solid pieces of food from the oral cavity the suction hose can be used without suction catheter. 9

3.0 Connecting, starting and operating the Atmoport N 3.2 Starting the unit In order to fully charge the battery, connect the charging power pack to the mains supply or the car connecting cable to the cigarette lighter of the car and join it with the socket (1.8, Fig. 1) on the Atmoport N. Always connect the suction unit to the charging power pack when the unit was used in order to have a 100% fully charged unit available when required. The car connecting cable supplied with the unit is used for operating the unit and for charging the battery. The charging procedure takes 1-2 hours when the battery is empty. Operation in car: If no mains connection is possible inside the house, operation of the unit is possible employing the 12 volt car battery via a car connecting lead. To do this, plug the car connecting lead into the low-voltage junction box of the unit and the universal low-voltage plug into the cigarette lighter socket of the car. Line voltage operation: Connect the charging power pack to the mains (Fig. 1.11) and the low voltage attachment (Fig. 1.12) to the socket on the Atmoport N (Fig. 1.8). Pay attention to correct voltage values. Use the unit only with bacterial filter and overflow safety. If the battery is discharged, the unit may also be operated with connected charging power pack. In this case, however, the battery is not being charged. The unit may be used in upright position only. As soon as the collection canister contains liquid the unit must be placed into upright position. The inserted overflow safety can work in upright position only, whether the unit is being used or not. The unit may be stored away or transported in horizontal position only when the collection canister has been completely emptied. Before transporting the unit, make sure that the cover is firmly closed. Operate the unit with 12 volt car voltage only, using the original connecting lead (not for use with 24 volt car voltage).

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3.0 Connecting, starting and operating the Atmoport N 3.3 Operation If the Atmoport N is used e.g. for suction of mucus from the upper respiratory tract, proceed as follows: – Adjust your desired maximum vacuum by closing the suction hose opening (fig. 3.2) with the finger ; the vacuum is then generated. Open the regulating valve (fig. 1.9) until the vacuumgauge shows the desired vacuum value (fig. 2). – Choose a suction catheter of the right size (e.g. Unoplast catheters, fig. 3.4, which are available from ATMOS in 3 different sizes) or a suction instrument which is only available from specialized dealers. – Join the suction tube (fig. 3.2) and the suction catheter (fig. 3.4) by means of the fingertip (not included in delivery, please order seperately REF 000.0347.0) (fig. 3.3). – Then, lead in the catheter in the same way as shown by your hospital staff and start the suction procedure. Never start suction procedures without having been instructed by hospital staff. Attention: Suction procedures in the respiratory tract may only be implemented after appropriate instruction by hospital or special staff. – Control the suction procedure with the finger tip. – Rinse suction catheter and suction tube with clean water after every suction procedure. Make sure that the collection canister is evacuated in time. As soon as the canister is half-filled, it must be emptied (this principle proves right in all application ranges). – When the maximum level is exceeded, the overflow safety reacts and suction is stopped. Empty the canister as described in section 4.1. If secretion has penetrated the pump, the Atmoport N has to be maintained by a service technician.

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Fig. 2 Vacuumgauge

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3.0 Connecting, starting and operating the Atmoport N

3.1

3.2

3.3

3.4

Fig. 3 Finger tip AUXILIARY AIR VENT OPEN = suction procedure is interrupted (e.g. when leading in the catheter) AUXILIARY AIR VENT CLOSED WITH THE FINGER = suction

3.4 Operating modes 1.

Suction

Indicator light for external supply > 80 % > 60 %

Indicator light for battery capacity

> 40 % Low

 Battery capacity below 40 %, battery has to be charged  if the light flashes, the battery is empty ON/OFF switch

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3.0 Connecting, starting and operating the Atmoport N 2.

Charge the battery Indicator light for external supply > 80 % > 60 % > 40 % Low

 Permanent light = charging procedure is completed  Running light from from below to above = battery is still charged

3.5 Charge the battery

ON/OFF switch New processor-controlled charging electronics de-termine, between charging current impulses, the energy reserve and condition and adjust charging current parameters acc. to the respective charging characteristic. Complete charging is thus achieved and charging procedure is automatically finished and indicated. The charging period comes to approx. 2 hours. The battery can be charged by mains or 12 V low voltage supply.

When starting the unit for the first time or after a long period of time when the unit has not been used we recommend starting the charging procedure once again. To do so, remove the power cord or the 12 V low voltage attachment from the unit and insert it again. Correct handling of the rechargeable batteries prolongs their maximum service life. Rechargeable batteries are wearing parts and therefore excluded from the 2 years‘ product liability!

3.6 Electrical connections –

For mains operation: Connection via the charging power pack. Low voltage connection via the low voltage socket 12 Volt DC. Attention, only use cable intended for this purpose.

–

Operation in car via the 12 V connection cable joined with the car mains or the cigarette lighter.

Operation of the suction pump is possible with both kinds of connection. Attention: Double-pole and quadripolar connector plugs can be used. Please pay attention when using the double-pole connector it must be plugged in centrally in the charging socket. 13

4.0 Cleaning and servicing 4.1

Evacuating the collection canister – Take off the connection hoses (suction hose and unit connection hose) from lid. – Withdraw collection canister with lid from the guides upwards. – Open the collection canister lid by lifting. – You can then empty the collection canister.

4.2

Cleaning the collection canister parts Before emptying and cleaning the collection canister, remove the electrical connections from the unit. Collection canister and collection canister lid can be rinsed under running water or cleaned in an automatic cleaning device.

4.3

Cleaning and disinfection The unit can be wiped with a moist (not wet) cloth. Basically, all parts which come into contact with secretion must be cleaned and disinfected after each suction procedure. Dependent on the application con-ditions, the hospital staff may determine other cleaning- and disinfecting- agents and cycles. These parts may also be immersed in commercial disinfectants (see next page).

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Attention: The lid parts and silicone hoses might get dyed by some disinfectants; a fact which does not take effect on the attributes of the materials. The silicone parts and collection canister parts may also be boiled (for more that 10 min.).

4.0 Cleaning and servicing ATMOS recommends following disinfectants for instruments and surfaces. ATMOS guarantees unrestricted use of the unit only if the instructions by the respective manufacturer are observed.

Recommended instrument disinfectans: Disinfectant

Ingredients

non-ionic tensides <5g NTA (nitrilotriacetic acid) 5-15 g enzymes, preservative agent

Dr. Weigert, Hamburg

Gigasept FF new (Application concentrate)

succinic acid dialdehyde dimethoxy tetrahydrofurane corrosion inhibitors

Schülke & Mayr, Norderstedt

neodisher MediClean forte (Application concentrate)

(per 100 g)

11,0 g 3,0 g

Manufacturer

Recommended surface disinfectans: Disinfectant

Ingredients

magnesium monoperoxyphthalate hexahydrate 80 g

Bode Chemie, Hamburg

Green & Clean SK (Application concentrate)

alkyl-dimethyl-benzyl<1g ammonium chloride dialkyl-dimethyl-ammonium chloride

Metasys, Rum (Österreich)

Dismozon pur (Application concentrate)

(per 100 g)

Manufacturer

If using aldehyde-containing or amine-containing disinfectants at the same object, this may result in discolourations.

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4.0 Cleaning and servicing 4.4 Bacterial filter Fig. 4 Bacterial filter 4.1

4.1 4.2

Bacterial filter Filter connection

4.2

This suction unit may be used with bacterial filter only !

4.4.1

General

There is a bacterial filter (Fig. 4.1) at the lid of the Atmoport N which a) protects the interior of the unit against contamination, b) stops the flow of liquids due to its hydrophobic features. Together with the mechanical overflow safety this filter prevents sucking in of secretion into the interior of the unit, and, due to this, failure of the unit Attention! The bacterial filter is a consumable and is neither autoclavable nor can it be disinfected. For hygienic reasons an exchange of the filter is recommended at least every 7 days, but at the latest when the device is used for an other patient.

4.4.2

Filter change Removing the filter: Remove the filter from the unit and take off the silicone hose. Dispose of the filter. Installing the filter: Connect the new filter to the silicone hose (after the silicone hose has been cleaned and disinfected). Reconnect filter to connection 4.2.

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4.0 Cleaning and servicing 4.4 Bacterial filter (contin.) Recommendation: – – –

In private use, the filter should be replaced every 2 to 3 weeks. If suction performance decreases, the filter has to be changed earlier ! In hospital use, the filter must be replaced every week. If, with the unit switched on and the suction hose open, the vacuum display changes to a value below -0.3 bar, the filter is blocked and must be replaced.

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Attention: Please take care that there are always sufficient spare filters available. (Filter, Art.No. 312.0439.0)

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Make sure that the collection canister is not filled more than half, in order to prevent secretion to get into contact with the filter. In this way, you can carry out many suction procedures with the filter.

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Pay attention to correct hose connections of suction system and to correct function of overflow safety.

Secretion canister lid Housing

x

x

cleaning

x

disinfection

x

cleaning / disinfection

x

x x x x

Bacterial filter

exchange

Fingertip

exchange

Suction hose

cleaning disinfection

Connecting hose Hose connector

disinfection

after 4 weeks

x

disinfection

1x per week

cleaning

1x per day

after suction procedure

Secretion canister

afetr each patient

Information on cleaning

x x

x

x

exchange

x

exchange exchange

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5.0 Trouble-shooting list

Possible causes

Remedy

The Atmoport N was subjected to a thorough quality control before shipment. If there is, nevertheless, some malfunction, you possibly might solve this problem yourselves if you observe the following instructions: Problem

– Check connection to supply socket – Check inbuilding fuse – Check whether power plug on the unit is loose – Replace fuse – Charge battery

– Loose power plug and discharged battery – No power voltage and battery is discharged – Defective fuse (charging power pack) – Discharged battery

– Charge battery

 Unit does not start

 Insufficient performance

– Leakages within the hose system or in collection canister lid – Clogged filter (vacuumgauge indicates vacuum) – Discharged battery

– Unit has to be returned for repair

– Check filling level of collection canister; evacuate canister, if necessary; clean overflow safety and check free movement of the float – Replace filter in collection canister lid and check correct hose connections – Unit has to be returned for repair

– Check collection canister lid and hose system – Clean or replace filter

– Float of overflow safety closes the collection canister inlet

– Electronics are defective

– Secretion or blood has been sucked in and valve plates of the pump are contaminated

– Blocked filter

 No suction

 Indicators flash irregularly

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6.0 Spare parts and accessories Fig. 5a Atmoport N

5.1

5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8

5.2 5.3 5.4

Silicone connection hose Bacterial filter Collection canister lid Collection canister Hose connector Suction hose Finger tip Suction catheter

5.5

5.6

5.7

5.8

Fig. 5b Finger tip

6.1 6.2

Fig. 6 Collection canister lid 6.1 6.2

Float sleeve Float

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6.0 Spare parts and accessories Spare parts for Atmoport N: Fig.

Description

Article-No.

5.1... Connection hose, silicone, ø 6mm ... 320.0047.0 5.2... Bacterial filter ... 312.0439.0 5.3... Collection canister lid ... 312.0625.0 5.4... Collection canister 1l ... 312.0626.0 5.5... Hose connector 7 - 10 ... 000.0239.0 5.5... or - hose connector 9 - 13 ... 000.0268.0 5.6... Suction hose, ø 6mm ... 000.0013.0 5.7... Hose connector (finger tip) ... 000.0347.0 6.1... Float sleeve ... 312.0442.0 6.2... Float ... 320.0015.0 no fig. ... Car connecting cable (12 V car mains) ... 312.0436.0 no fig. ... Battery pack NEW ... 312.0425.0 no fig. ... EXCHANGE battery pack (reprocessed in factory) ... 312.0425.1 no fig. ... Shoulder bag, orange ... 312.0450.0 no fig. ... Support for use in car ... 312.0410.0 no fig. ... Operating instructions ...312.0400.B Attention: The manufacturer considers himself responsible for safe operation of the unit only if original accessories and spare parts are used.

Accessories for Atmoport N: Fig.

Description

Article-No.

5.8... Unoplast suction catheters "Optimal", straight, central opening, 2 small lateral openings, length: 50 cm, each packed separately and sterile in packing lots of 100 pcs. Size: Charrière 12 ...000.0294.0 Charrière 14 ...000.0295.0 Charrière 16 ...000.0296.0 no fig. ... Rinsing canister 250 ml ... 000.0504.0 no fig. ... Lid for rinsing canister ... 000.0504.1 no fig. ... Charging power pack ...312.0449.0 20