OPERATING INSTRUCTIONS MEDAP CAP PLUGS
Subject to technical modification! Illustrations and technical specifications may vary slightly from those in these Operating Instructions as a result of ongoing product development. V04 2017-08 2
Table of contents Table of contents 1 Introduction...5 1.1 Environmental protection...5 1.1.1 Packing...5 1.1.2 ATMOS products...5 1.2 How to use these operating instructions...5 1.2.1 General...5 1.2.2 Symbols...5 1.2.2.1 Cross-references... 5 1.2.2.2 Actions and responses... 5 1.2.3 Definitions...6 1.2.3.1 Design of safety notes... 6 1.2.3.2 Design of other notes... 6 1.2.4 Symbols used...6 1.3 Pictorial guide...7 1.3.1 Pictorial guide of cap plug... 7 1.4 Basic requirements...7 1.4.1 Use in accordance with the intended purpose...7 1.4.2 Applicable standards... 7 1.4.3 Intended purpose...8 1.4.4 Interface description... 8 1.4.4.1 Septic fluid jar including septic fluid jar cap... 8 1.4.4.2 Vacuum connection tube...9 1.4.4.3 Suction tube... 9 2 Safety notes...10 3 Initial operation... 11 3.1 General... 11 3.2 Inserting cap plug...12 3.3 Mounting tubes...12 4 Operation...13 4.1 Prior to use...13 4.2 Suction process when using a cap plug...13 4.3 Disassembly...14 4.3.1 Disassembly of tubes... 14 4.3.2 Removing cap plug...14 5 Cleaning and disinfection...15 5.1 General...15 5.1.1 Cleaning...16 5.2 Disinfection...16 3
Table of contents 5.3 Disinfection procedures...18 6 Malfunctions and troubleshooting...19 7 Maintenance...20 7.1 General...20 7.2 Repairs...20 7.3 Service hotline:...20 7.4 Sending in the device...20 8 Technical specifications...21 8.1 General...21 8.2 Ambient conditions...21 4
Introduction Environmental protection 1 1 Introduction 1.1 Environmental protection 1.1.1 Packing The packing is made of materials compatible with the environment. ATMOS will dispose of the packing materials upon request. 1.1.2 ATMOS products ATMOS will take back used products or those which are no longer in service. Please contact your ATMOS factory representative for more detailed information. 1.2 How to use these operating instructions 1.2.1 General These operating instructions are provided to familiarise you with the features of this ATMOS product. They are subdivided into several chapters. Please note: Please read these operating instructions carefully and completely before using the product for the first time. Always proceed in accordance with the information contained herein. Store these operating instructions in a location near the product. 1.2.2 Symbols 1.2.2.1 Cross-references References to other pages in these operating instructions are identified with a double arrow symbol. 1.2.2.2 Actions and responses The symbol identifies an action taken by the user while the symbol identifies the reaction that this will induce in the system. Example: Turn on the light switch. 99 Lamp lights up. 5
1 Introduction How to use these operating instructions 1.2.3 Definitions 1.2.3.1 Design of safety notes Pictogram Descriptor Text DANGER! Indicates a direct and immediate risk to persons, which may be fatal or result in most serious injury. WARNING! Indicates a potential risk to persons or property which may result in health hazard or grave property damage. CAUTION! Indicates a potential risk to property which may result in property damage. The text for the safety note describes the type of risk and how to avert it. Tab. 1: Design of safety notes 1.2.3.2 Design of other notes Pictogram Descriptor Reference to NOTE Supplementary assistance or further useful information without potential injury to persons or property damage is described in the text of the note. Tab. 2: Design of other notes 1.2.4 Symbols used Symbols Identification Labelling for Class I products, developed and marketed in compliance with Medical Device Directive 93/42/EEC. Tab. 3: Symbols 6
Introduction Pictorial guide 1 1.3 Pictorial guide 1.3.1 Pictorial guide of cap plug 1 2 Fig. 1: Pictorial guide of cap plug 1 Cap plugs surgical 9/12, chrome plated (REF 5750 0396) 2 Cap plugs surgical 9/12, plastic (REF 5752 0184) High VAC, gasket, green 1.4 Basic requirements 1.4.1 Use in accordance with the intended purpose This product is a medical device according to the Medical Device Directive 93/42/EEC. This product is to be used exclusively for human medicine. Accessories Accessories or combinations of accessories may be utilised only as and when indicated in these operating instructions. Use other accessories, combinations and parts subject to wear only if these are intended expressly for the application and will not adversely affect performance features or safety requirements. 1.4.2 Applicable standards The product satisfies the basic requirements set forth in Annex I to the 93/42/EU Directive drafted by the Medical Products Council (Medical Products Directive) as well as the applicable national (German) codes and the Medical Products Act in Germany. The applicable standards include the following: DIN EN ISO 10079-1 Medical suction equipment - Part 1: Electrically powered suction equipment DIN EN ISO 10079-3 Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source 7
1 Introduction Basic requirements 1.4.3 Intended purpose Name: Main function: Medical indications / application: Specification of the main function: User profile: Patient groups: Application organ: Application time: Application site: Contraindications: The product is: Sterility: Single-use product / reprocessing: Cap plugs In combination with a septic fluid jar and a septic fluid jar cap REF 5750 0390 collection of secretion, blood, serous fluids, rinsing fluids along with any contained particles For all applications which require aspiration The cap plug is used to quickly couple a septic fluid jar cap for equipment rail REF 57500390 with tubes to patient and vacuum source. The cap plug is inserted into the opening of the septic fluid jar cap for equipment rail REF 5750 0390. The tube to the patient is attached to the thicker opening of the cap plug, the tube to the vacuum source to the thinner opening of the cap plug. Doctor, medically trained staff Patients of all ages Natural and artificial body orifices For continuous operation; in practice short-term use on the patient (< 30 days) The application site is the clinical environment and doctor s practices. The application of the product may only be performed by medically trained and introduced staff. The cap plug may not be used for the following purposes: Outside the medical sector In MR areas In the home care sector Being operated directly by the patient With flammable or explosive liquids For drainages in the low vacuum range (e.g. thoracic and wound drainage) For contact with strong acids or bases Do not use the cap plug made of metal REF 5750 0396 in cardiac surgery and in CNS surgery (no use in CF, as the metal is conductive). Without an overflow protection in direction vacuum source Not active No sterile product For information on reprocessing and cleaning please see the operating instructions. 1.4.4 Interface description 1.4.4.1 Septic fluid jar including septic fluid jar cap The septic fluid jar is used to collect the septic fluids extracted. Septic fluid jars with mounted septic fluid jar cap will be referred to as suction set in the following. 8
Introduction Basic requirements 1 Technical specifications Vacuum resistant down to -95 kpa (may not collapse). Prerequisites The septic fluid jar cap (REF 5750 0390) may only be used in conjunction with a hydrophobic bacterial and viral filter. Low leakage. Capacity of 1 l to 5 l. Always fix septic fluid jars firmly and ensure safe connection to the equipment rail 25 x 10 mm. The outside diameter of the connector nipple on the patient side shall match the inside diameter of the suction tube. 1.4.4.2 Vacuum connection tube The vacuum connection tube is used to connect the vacuum source and the cap plug. Technical specifications Shore hardness of 60 Internal diameter of 6-8 mm Vacuum resistant down to -95 kpa (may not collapse). Maximum length depends on the system, however, not longer than 1 m and installing without protruding tube loops Prerequisites The vacuum connection tube must comply with the hospital's standards for hygiene. The inside diameter of the vacuum connection tube shall match the outside diameter of the connector nipple on the unit. The inside diameter of the vacuum connection tube must match the outside diameter of the connector on the cap plug. The vacuum connection tube will be referred to only as "connection tube" below. 1.4.4.3 Suction tube The suction tube is used as connection between cap plug and fingertip or applicator. Technical specifications Shore hardness of 60 Vacuum resistant down to -95 kpa (may not collapse). Length 1.3 m - 3.0 m Inside diameter for various cap plugs in accordance with the table Prerequisites The suction tube must comply with the hospital's standards for hygiene. The inside diameter of the suction tube must match the outside diameter of the connector on the septic fluid jar cap at the patient side. Product name REF number Inside diameter of suction tube Cap plug 5750 0396 8 mm Cap plug 5752 0184 8 mm Tab. 4: Inside diameter of suction tube 9
2 Safety notes Basic requirements 2 Safety notes WARNING! Risk of injury! ATMOS products may be used only if they are in perfect working order. Check to ensure that the ATMOS product is fully functional and in good working order prior to use. WARNING! Infection hazard! Contaminated components may endanger the health of the staff and the patients. Ensure the product is prepared as per hygiene standards before using it for the first time. 10
Initial operation General 3 3 Initial operation 3.1 General DANGER! Functional check! The product is used in the treatment of patients. Any restriction in the unit's performance can result in serious complications in treatment. Perform a complete functional check every time before using the unit. DANGER! Infection hazard due to oversuction! To avoid the ingress of fluid or foam into the product or the vacuum source, a hydrophobic bacterial filter must be used. If secretions enter into the insides of the unit, the product must immediately be taken out of operation. Clean and disinfect the product and have it repaired by a service technician authorised by ATMOS to do so. DANGER! Infection hazard due to contamination! To avoid the ingress of fluid or foam into the product or the vacuum source, a hydrophobic bacterial filter must be used. If bacteria or viruses enter into the inside of the unit, the product must immediately be taken out of operation. Clean and disinfect the product and have it repaired by a service technician authorised by ATMOS to do so. WARNING! Infection hazard! Contaminated components may endanger the health of the staff and the patients. Ensure the product is prepared as per hygiene standards before using it for the first time. WARNING! Foaming! Foam may be created when extracting secretion. Foam may impair the function of the overflow protection device. Use a standard commercial foam inhibitor. CAUTION! Property damage! Proper functioning of the mechanical overflow protection is only assured with the product in upright position. Place the product in upright position during operation. When using a trolley the castors shall be locked during operation. NOTE Connecting several septic fluid jars in series can cause delayed suction effect and reduced suction power. 11
3 Initial operation Inserting cap plug NOTE Before mounting ensure that the gasket is inserted in the housing and not damaged. NOTE Select accessory for the suction set in accordance with the application, e. g. diameter of the tube, size of the connector of the septic fluid jar cap. 3.2 Inserting cap plug 1 Inserting cap plug Insert cap plug (1). 99 Suction set is ready for use. Mounting tubes. Fig. 2: Inserting cap plug 3.3 Mounting tubes 3 4 2 1 Attach the connection tube (1) to straight connector (2) of the cap plug. Attach the other end of the connection tube to the overflow protection system, bacterial filter or vacuum source. Attach suction tube (3) to the second connector (4) of the cap plug. Fig. 3: Mounting tubes 12
Operation Prior to use 4 4 Operation 4.1 Prior to use Check all functions of the product before using it. Ensure that when using a cap plug, the cap plug is firmly seated in the housing; the tube connectors are firmly seated and tight; no mechanical forces are acting on the tubes; components made of plastic and rubber are in good condition and do not exhibit any deterioration due to aging; 4.2 Suction process when using a cap plug If a septic fluid jar is filled up to the "maximum marker, suction can be continued by connecting the cap plug to a second septic fluid jar. Replug the cap plug (1) with the tubes from the first into the second septic fluid jar cap. Aspiration may be continued. 1 Fig. 4: Replugging the cap plug 13
4 Operation Disassembly 4.3 Disassembly 4.3.1 Disassembly of tubes 1 4 3 Remove the suction tube (1) from the connector (2) of the cap plug. Remove connection tube (3) from the straight connector (4) of the cap plug. Remove the other end of the connection tube from the overflow protection system, bacterial filter or vacuum source. 2 Fig. 5: Detaching tubes 4.3.2 Removing cap plug 1 Removing cap plug Detach the cap plug (1) from the septic fluid jar cap. Fig. 6: Removing cap plug 14
Cleaning and disinfection General 5 5 Cleaning and disinfection 5.1 General WARNING! Infection hazard! Any and all the parts of the product could be contaminated. Wear gloves and be absolutely sure to follow the hygiene rules during all cleaning and reconditioning work. CAUTION! Improper cleaning can cause property damage! Use only as much cleaning agent or liquid as is absolutely necessary and use a damp cloth to remove any excess cleaning agents and liquid. WARNING! Infection hazard! Particles of grime can become encapsulated and result in components not being sterile after disinfection. That is why all components have to be thoroughly cleaned prior to disinfection and stubborn dirt removed with a cloth and suitable cleaning agent. CAUTION! Improper cleaning can cause property damage! Abrasive cleaners will damage the surfaces. Use only all-purpose cleaners which are slightly alkaline (soap solution) and contain tensides and phosphates as the active cleaning agents. NOTE The parts will have to be cleaned and dried prior to disinfection. NOTE Be absolutely sure to follow the instructions for use provided by the manufacturer of the cleaning and disinfectant agent. NOTE The product can be reused after cleaning and disinfection. NOTE The suction sets are not used sterile. 15
5 Cleaning and disinfection Disinfection 5.1.1 Cleaning NOTE In case the product is very dirty, carry out prior disinfection procedure before cleaning the product. Wipe product and components thoroughly with a slightly moistened cloth using an allpurpose cleaning agent in solution. Remove encapsulated residues by rubbing vigorously. Wipe product and components thoroughly with a cloth slightly moistened with water. Dry product and components immediately. 99This will help to inhibit pathogen growth on the product's surface. Wipe disinfect the product after every cleaning process. 5.2 Disinfection WARNING! Risk of injury! Disinfectants may contain substances hazardous to health, which may cause injuries on contact with skin and eyes. Protect the skin and eyes and observe the hygiene rules when working with disinfectants. WARNING! Functional failure! Check the unit's components for proper functioning after each cleaning or disinfection procedure. CAUTION! Property damage resulting from improper handling! Be absolutely sure to follow the instructions for use provided by the manufacturer of the disinfectant. NOTE Using drapes which are not colourfast can cause discolouration in plastic components. 16
Cleaning and disinfection Disinfection 5 CAUTION! Property damage! If used over an extended period of time, alcohol-based disinfectants can damage surfaces and accessories. Disinfectant agents which have been approved for use: Use only instrument and surface disinfectants with the following combinations of active ingredients: Aldehydes Quarternary compounds or Guanidine derivatives. Disinfectants which are not approved for use: Pure hand disinfectants, since these usually contain alcohol or compounds of alcohol Disinfectants containing alcohol, since alcohol applied in excess (i.e. accumulations of liquids containing alcohol remaining on the surface for more than about 5 minutes) can damage the surface. Aldehydes, quaternary compounds and guanidine derivatives will not attack surfaces and will pass recurring hygiene inspections. Thanks to the markedly longer evaporation period and extended residence of the disinfectant agent on the surface, germicidal effect beyond 95 % is achieved within a few minutes, provided that coarse soiling is removed beforehand. Please refer to the following list for information on active ingredients. Ingredient group Aldehydes Quarternary compounds Guanidine derivatives Tab. 5: Active ingredients Active ingredients in disinfectants 2-ethyl-1-hexanal, formaldehyde, glutardialdehyde, glyoxal, o-phthaldialdehyde, succinaldehyde Alkyl-didecyl-polyoxethyl ammonium propionate, alkyl-dimethylalkylbenzyl ammonium chloride, alkyl-dimethyl-ethyl ammonium chloride, alkyl-dimethyl-ethylbenzyl ammonium chloride, benzalkonium propionate, benzalkonium chloride (alkyl-dimethylbenzyl ammonium chloride, coco-dimethyl-benzyl ammonium chloride, lauryl-dimethylbenzyl ammonium chloride, myristyldimethyl-benzyl ammonium chloride), benzethonium chloride, benzyl-dihydroxyethyl-coco-alkyl ammonium chloride, dialkyldimethyl ammonium chloride (didecyldimethyl ammonium chloride), didecyl-methyl-oxyethyl ammonium propionate, mecetronium-ethyl sulfate, methyl-benzethonium chloride, n-octyl-dimethyl-benzyl ammonium chloride Alkyl-biguanide, chlorhexidine-digluconate, cocospropylenediamine guanidinium diacetate, oliogomeric biguanide, polyhexamethylene biguanide hydrochloride (oligo-diimino imiodocarbonyl imino-hexamethylene, polyhexanide) 17
5 Cleaning and disinfection Disinfection procedures 5.3 Disinfection procedures Different disinfection procedures may be used for the various components, depending on the properties of the materials. Components Cap plugs X X In solution 1 Wipe, spray disinfection 2 1 After exposure (as prescribed in the manufacturer's instructions), rinse components thoroughly with water and dry them afterwards. 2 After exposure (as prescribed in the manufacturer's instructions) remove disinfectant residues from the components using a moist cloth and dry them afterwards. Tab. 6: Disinfection procedures 18
Malfunctions and troubleshooting Disinfection procedures 6 6 Malfunctions and troubleshooting Defect Source of malfunction Corrective actions No or reduced displacement Tab. 7: The cap plug has not been plugged properly into the septic fluid jar cap. Gasket is not tight or porous. Tubes do not match the cap plug. Malfunctions and troubleshooting Check proper seat. Check the gasket of the cap plug, if necessary, replace. Use tubes in accordance with table of connection description. 19
7 Maintenance General 7 Maintenance 7.1 General Maintenance, repairs and period tests may only be carried out by persons who have the appropriate technical knowledge and are familiar with the product. To carry out these measures the person must have the necessary test devices and original spare parts. ATMOS recommends: Work should be carried out by an authorized ATMOS service partner. This ensures that repairs and testing are carried out professionally, original spare parts are used and warranty claims remain unaffected. 7.2 Repairs The following may require repairs from the manufacturer or an authorized service partner: Liquid has penetrated the device. The performance has significantly decreased. Inexplicable notifications appear. Abnormal noises occur. Functional faults cannot be rectified according to the measures in chapter Malfunctions and troubleshooting [ page 19]. If defects are detected the product may not be used any longer. Make a note of the deficiencies and the REF number on the data plate and inform the responsible ATMOS Service. Observe the information in chapter Sending in the device [ page 20]. 7.3 Service hotline: +49 7653 689-0 7.4 Sending in the device Remove and properly dispose of consumables. Clean and disinfect the product and accessories according to the operating instructions. Place used accessories with the product. Fill in the form QD 434 Delivery complaint / return shipment and the respective decontamination certificate. This form is enclosed with each delivery and can be found at www.atmosmed.com. The device must be well padded and packed in suitable packaging. Place the form QD 434 Delivery complaint / return shipment and the respective decontamination certificate in an envelope. Affix the envelope to the outside of the package. Send the product to ATMOS or to your dealer. 20
Technical specifications General 8 8 Technical specifications 8.1 General Classification as per Annex IX of the 93/42/EEC Directive Class I 8.2 Ambient conditions Temperature Relative humidity Atmospheric pressure -15 C to +50 C (shipping) +5 C to +35 C (operation) 10 % to 95 % (shipping) 30 % to 75 % (operation) 700 hpa to 1060 hpa (shipping) 700 hpa to 1060 hpa (operation) 21
Notes
Notes
Manufacturer: ATMOS MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Str. 16 79853 Lenzkirch GERMANY Phone: +49 7653 689-0 www.atmosmed.com