MEDAP FINA VAC D 150 Скачать руководство пользователя страница 11

Introduction

Basic requirements

GA 5752 2135 GB 18

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1

Contraindications:

The FINA VAC D 150 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
•  For vacuum extraction
•  For the aspiration of flammable or explosive liquids
•  For the aspiration of smoke that is generated during HF and 

laser surgery without the connection of an intermediate smoke 

filter

•  For thoracic drainages
•  For surgical aspiration
•  For bronchial aspiration
•  With central gas supply systems with supply pressures other 

than −100 kPa bis −60 kPa

The product is:

Active

Sterility:

Not a sterile product

Single-use product / 

reprocessing:

The device and parts of the accessories are reusable. For 

information on reprocessing, cleaning and disinfection, please see 

the operating instructions.

1.6.4 

Versions of the FINA VAC D 150

The connection of the FINA VAC D 150 to the terminal unit for vacuum depends on the model 

being used:

Version A: Tapping unit with integrated gas pin

•  FINA VAC D 150 is fitted directly to the terminal unit.

Version B: Tapping unit with rail clamp and NIST connection

•  FINA VAC D 150 is designed for mounting onto a 25 x 10 mm equipment rail and is supplied 

via a NIST connection with vacuum from a terminal unit connected using a connection tube 

with gas probe.

Products and accessories are only permitted with ISO colour coding. In Germany, Austria and 

Switzerland, products with neutral colour coding are also permitted.

NOTE

The products are supplied with ISO coding. The scope of delivery includes a label 

for neutral colour coding.

The product is available in the following versions:
•  FINA VAC D 150 Wall DIN ISO (REF 5752 3739)
•  FINA VAC D 150 Equipment rail ISO (REF 5752 3740)

Содержание FINA VAC D 150

Страница 1: ...OPERATING INSTRUCTIONS TAPPING UNIT FOR DRAINAGE MEDAP FINA VAC D 150 GA 5752 2135 GB 18...

Страница 2: ...2135 GB 18 2 Subject to technical modification Illustrations and technical specifications may vary slightly from those in these operating instructions as a result of ongoing product development V18 20...

Страница 3: ...versions 9 1 6 Basic requirements 9 1 6 1 Use in accordance with the intended purpose 9 1 6 2 Applicable standards 10 1 6 3 Intended purpose 10 1 6 4 Versions of the FINA VAC D 150 11 1 6 5 Interface...

Страница 4: ...Cleaning procedure 25 6 3 Disinfection 25 6 3 1 General 25 6 3 2 Suitable disinfectants 26 6 3 3 Disinfection procedure 26 6 4 Product specific safety notes 26 7 Maintenance 28 7 1 General 28 7 2 Per...

Страница 5: ...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 1 Abbreviations EN European standard EEC Eur...

Страница 6: ...lows 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 ENVIRONME...

Страница 7: ...ance with the ISO 15223 1 standard Symbol for Relative humidity Labelling in compliance with the ISO 15223 1 standard Symbol for Atmospheric pressure Tab 3 Symbols 1 4 Disposal WARNING Infection hazar...

Страница 8: ...9 7 7 6 6 4 4 8 8 6 6 Fig 1 Overview of the FINA VAC D 150 1 Vacuum gauge 7 Hydrophobic bacterial and viral filter 2 Housing 8 Tube connector of mechanical overflow protection 3 Control valve 9 Mechan...

Страница 9: ...B Tapping unit with rail clamp and NIST connection 5 Rail clamp 1 6 Basic requirements 1 6 1 Use in accordance with the intended purpose Product As per Annex IX to the Medical Devices Directive 93 42...

Страница 10: ...iration of secretion blood and serous fluids Medical indications application The FINA VAC D 150 is designed for the precise regulation of vacuum and used for postoperative aspiration of wound exudate...

Страница 11: ...g cleaning and disinfection please see the operating instructions 1 6 4 Versions of the FINA VAC D 150 The connection of the FINA VAC D 150 to the terminal unit for vacuum depends on the model being u...

Страница 12: ...iameter of the tube connector on the septic fluid jar cap of the pump The vacuum connection tube will be referred to only as connection tube below 1 6 5 2 Hydrophobic bacterial and viral filter In its...

Страница 13: ...he suction tube 1 6 5 5 Utensil Suction catheters or lances for example are referred to as utensils The utensils are used to extract septic fluids Prerequisites The inner diameter of the utensil s con...

Страница 14: ...incorrect spare parts and accessories can cause injuries or equipment failure Only use original accessories or spare parts DANGER Infection hazard due to oversuction To avoid the ingress of fluid or f...

Страница 15: ...is raises the risk that secretion may penetrate the product and cause it to break down Use an ordinary foam inhibitor WARNING Risk to patient Use the special tapping unit for thoracic draining for vac...

Страница 16: ...ble for vacuum extraction The product may not be used without a hydrophobic filter The product may not be used without a bacterial and viral filter The product may not be used without a septic fluid j...

Страница 17: ...roduct according to the hygiene guidelines before using it Clean and disinfect the product NOTE In order to ensure the functionality carry out a function check prior to use 3 2 Mounting 3 2 1 Mounting...

Страница 18: ...ersion B Tapping unit with rail clamp and NIST connection _ With the upper edge of the guide groove at the front position the rail clamp 1 at a slight angle on the equipment rail 2 and then press it a...

Страница 19: ...extraction utensil 1 1 2 2 3 3 4 4 Fig 6 Connection of the mechanical overflow protection Connection of the mechanical overflow protection _ Plug the overflow protection device 1 directly onto the tu...

Страница 20: ...viral filter The inlet side must face the patient and the outlet must face the tapping unit _ Then plug the connection tube to the tube connector 4 on the housing of the tapping unit _ Connect the con...

Страница 21: ...terial and viral filter are mounted fully functional and no residue is trapped in it The tube connectors are firmly secured and tightly sealed and no mechanical forces are act ing on the tubes The pla...

Страница 22: ...2 leading to the septic fluid jar and set the vacuum with the control valve while doing so Turn anticlockwise Read the value on the vacuum gauge 3 In case of malfunctions e g insufficient vacuum leve...

Страница 23: ...the patient _ Close the control valve _ Empty the septic fluid jar and recondition or replace it _ Remove the connection tubes and the overflow protection device the hydrophobic bacterial and viral fi...

Страница 24: ...mination and encapsulated particles of grime CAUTION Improper cleaning and disinfection can cause property damage Do not use the following products for cleaning and disinfection Products containing al...

Страница 25: ...ect dose of all purpose detergent with water for the degree of surface contamination and in accordance with the instructions of the detergent manufacturer _ Thoroughly wipe off the product with a soft...

Страница 26: ...lauryl dimethylbenzyl ammonium chloride myristyl dimethyl benzyl ammonium chloride benzethonium chloride benzyl dihydroxyethyl coco alkyl ammonium chloride dialkyl dimethyl ammonium chloride didecyld...

Страница 27: ...if the tapping unit is not cleaned properly after being exposed to oversuction as safety equipment could be clogged After oversuction products must be dismantled and cleaned thoroughly by authorised...

Страница 28: ...ts At least every 5 years a test must be performed 7 3 Malfunctions and troubleshooting Defect Source of malfunction Corrective actions No or low vacuum No or reduced flow rate Regulation of flow rate...

Страница 29: ...not suspended high enough above the patient s chest Suspend unit higher or use overflow protection device Gas probe does not fit into the terminal unit Terminal unit for the wrong gas type Check gas t...

Страница 30: ..._ Fill in 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...

Страница 31: ...ing storage 700 hPa to 1060 hPa Atmospheric pressure Operation 700 hPa to 1060 hPa 8 3 Technical specifications Nominal pressure gas supply 100 kPa to 60 kPa Vacuum regulation range 0 to 13 kPa Flow r...

Страница 32: ...colour coding label Tab 7 Standard scope of delivery 9 2 Accessories 5752 1698 Mechanical overflow protection 5752 3330 Aspiration set for equipment rail 1 l 5752 5669 Aspiration set for wall mount 1...

Страница 33: ...Notes...

Страница 34: ...Notes...

Страница 35: ...Notes...

Страница 36: ...Manufacturer ATMOS MedizinTechnik GmbH Co KG Ludwig Kegel Str 16 79853 Lenzkirch GERMANY Telephone 49 7653 689 0 www atmosmed com...

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