General Surgery Operation Tables

Transcription

1 Sterilization Devices Washer Disinfectors General Surgery Operation Tables Warming Cabinets Blood Bank Refrigerators Stainless Hospital Equipments

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3 CONTENTS Corporation 4-5 Sterilization Devices 7-17 I. Central Sterilization Units II. Prismatic Steam Sterilizers III. Washing Steam Sterilizers IV. Laboratory-type Vertical Steam Sterilizers Washer Disinfectors General Surgery Operation Tables Warming Cabinets Neonatal Units I. Mother Milk Refrigerators II. Mother Milk Freezers III. Mother Milk Refrigerator and Freezers IV. Baby Bottle Heater V. Injector Heater VI. Baby Bottle and Injector Heater Blood Bank Refrigerators Stainless Hospital Equipments

4 About us Sümer A.Ş. was established in 1981 in Ankara to proved services in the medical device sector. It has aimed advancement since the day of its establishment by also taking growth and compliance with the contemporary technologies and protecting the environmental conditions. Our manufacturing takes place in an area of m 2 in Ankara Organized Industrial Zone. Our Firm is following the innovations in its sector and in abroad through its research and development unit and its application staff with a strong infrastructure of engineers, and is continuing to produce devices it had developed in computer environment based on such innovations with high technology and to contribute their development so as to be most beneficial for the Turkish medicine. With this purpose, our Firm is strictly following the Quality Management principles and rules from design of the products to the after sale servicing. Our Firm has been currently certificated for compliance with 9001 quality management system, medical device quality management system certificate and environment management system certificate and with product certificates under MDD 93/42/EEC Medical Devices Directive and PED 97/23/EEC Pressurized Equipment certificate. Furthermore, our steam sterilizers, and disinfection and washing devices have been certificated by the German accredited body. Our Firm is successfully implementing several projects supported by Tübitak, KOSGEB, and Ankara Development Agency. SÜMER A.Ş. has been awarded with the following: Ankara Industry Chamber Award for 2012, 2011 R&D Award, 2012 Success Award. Our Vision To make the Sümer brand a global brand to make our Firm remembered first in the sector. Our Mission Our main task is to create designs with competition power in the global sense by taking the priorities of the sector into consideration and being respectful to the environment and people and giving the first priority to the wishes and expectations of customers, and also to produce innovative technological medical products by meeting all the national and international legal requirements. Our Basic Values We are bound up with the Medical Ethical Rules, We are people-oriented, We respect environment, We are creative, We are customer-oriented, We are innovative, We are pro-active, We believe in the team spirit. Our Firm possesses the following certificates; CE Certificates under the following directives: 9001, 13485, Quality Management System, MDD 93/42/EEC Medical Devices, PED 97/23/EEC Pressurized Equipment 4 5

5 STERILIZATION DEVICES I. Central Sterilization Units II. Prismatic Steam Sterilizer III. Washing Steam Sterilizer IV. Laboratory Type Vertical Steam Sterilizer

6 I. Central Sterilization Units Our Firm implements turn-key sterilization projects designed by taking the hospital sizes into consideration, and gives services for the installation and commissioning of turn-key Central Sterilization Units. It is essential for Central Sterilization Units (CSU) to eliminate the microorganisms existing in hospitals. Sümer A.Ş. offers the following turn-key services for you, our valuable customers, in relation with the Central Stelization Units; Design, Central construction, Installation of products, Commissioning, Control and similar. Sterilization Cycle 1 TAKING OVER Taking over the materials requiring sterilization Sterilization Process DELIVERY Delivery of materials with broken sterility to the CSU 7 2 WASHING Washing the materials taken over. DECONTAMINATION STERILIZATION HANDING OVER Dispatching the sterile materials to relevant locations 6 3 PACKAGING Packaging the washed materials DISINFECTION VALIDATION STORAGE Storage of sterilized materials till use 5 4 STERILIZATION Sterilization of packaged materials Central Sterilization Units are indispensible dynamic centers with great responsibility in ensuring the sterilization safety and prevention of infections, collecting the contaminated materials from various locations in the hospital to process and redelivering them to users and providing continuous services throughout 24 hours during 365 days of the year. Sterilization must not be taken as a simple procedure; it must be considered as providing new materials suitable for medical purposes, or a process of novel production. 8 STERILIZATION DEVICES STERILIZATION DEVICES 9

7 II. Prismatic Steam Sterilizer This is produced for the sterilization of surgical and wound dressing tools, plastic and glass materials and bottled fluids by trained, certificated and officially assigned hospital staff. Productivity, Safety, Traceability Standard Programs Medical and Surgical Tool (134 C) Textile Materials (134 C) Heavy Materials (134 C) Plastic/Rubber Materials (121 C) Rubber/Glass (125 C) Fluids (121 C) Flash (134 C) Prion (134 C) ~ 60 min ~ 60 min ~ 65 min ~ 80 min ~ 60 min ~ 90 min ~ 20 min ~ 60 min Bowie & Dick Test (134 C) ~ 35 min Vacuum Leakage Test ~ 25 min Number of optional programs 99 Processing times are load-dependent, and are given as approximate figures. These times cover the entire sterilization process with an average load including the drying stage. Programs can be customized based on the needs of the customer. General Characteristics Control System Way of use Screen Type Screen Dimensions Keypad Printer Communication Warning system Data Storage Procedure follow-up/tracing Motility Vapor control PLC processor Full automatic / buttons and touch screen Color TFT, Touch LCD 7,0 (10,0 Optional) Touch Screen 40 Characters / lines, integrated thermal printer RS232 /485 Port - USB (Ethernet Optional) Warnings with audiovisual and written messages 200 cycles Analog indicators for the follow-up of Cell, Jacket, Generator and Air pressure in addition to the Touch Screen Easy orientation on 4 swivel castors and stabilization legs adjustable according to inclination of the floor Through pneumatic valves Body Cell Jacked Cover Panel Coating Piping AISI 304 Stainless steel 6 mm, AISI 316 L Stainless steel 3mm, AISI 316 L Stainless steel 6 mm, AISI 304 Stainless steel AISI 304 Stainless steel Brass, AISI 304 Stainless steel The entire piping can be made from AISI 304 stainless steel optionally. Our Sterilization Devices are designed and proıduced so as to be compliant with production and product standards. Type Tests for Prismatic Steam Sterilizer and Installation Validations have been implemented and certificated by the German accreditation Body HYGCEN GmbH under EN 285 and TS EN directives. 10 STERILIZATION DEVICES STERILIZATION DEVICES 11

8 Chamber Dimensions Weights Single Sliding Door Chamber volume (L) Chamber volume (L) Height (mm) Width (mm) Depth (mm) Weight of the Device (kg) Packaging Weight (kg) STU Capacity Dimensions Single Sliding Door Steam Sterilizer Weights Double Sliding Door Chamber volume (L) Height (mm) Width (mm) Chamber volume (L) Weight of the Device (kg) Packaging Weight (kg) Depth (mm) Dimensions Double Sliding Door Steam Sterilizer Volume and Power Chamber volume (L) Height (mm) Width (mm) Depth (mm) Chamber volume (L) Generator Power (3 Phase/400±10 VAC) 25 kw, 3 Phase / Installed Power 400 VAC ±10 EQUIPMENT-RELATED CHARACTERISTICS Main Supply Vapor Generator Volume (L) 20 kw 30 kw 40 kw 50 kw 60 kw 35 kw, 3 Phase / 400 VAC ±10 45 kw, 3 Phase / 400 VAC ± Bars 55 kw, 3 Phase / 400 VAC ±10 65 kw, 3 Phase / 400 VAC ± STERILIZATION DEVICES STERILIZATION DEVICES 13

9 III. Washer and Steam Sterilizer Steam Sterilizer Chamber Dimensions General Characteristics Control System PLC processor Way of use Full automatic/ buttons and touch screen Screen Type Color TFT, Touch LCD Screen Dimensions 7,0 Keypad Touch Screen Printer 40 characters/lines, integrated thermal printer Communication RS232/RS485 Port/USB (Ethernet Optional) Warning system Warnings with audiovisual and written messages Data Storage 200 cycles Procedure follow-up/tracing Motility Vapor control Body Cell Jacket Door Panel Coating Piping Analog indicators for the follow-up of Cell, Jacket, Generator and Air pressure in addition to the Touch Screen Easy orientation on 4 swivel castors and stabilization legs adjustable according to inclination of the floor through pneumatic valves AISI 304 Stainless Steel 6 mm, AISI 316 L Stainless Steel 6 mm, AISI 316 L Stainless Steel 20 mm, AISI 316 Stainless Steel AISI 304 Stainless Steel PTFE Hose, AISI 304 Stainless Steel Chamber volume (L) Height (mm) Width (mm) Depth (mm) Chamber volume (L) Height (mm) Width (mm) Depth (mm) STU Capacity Washing Chamber Dimensions Chamber volume (L) 100 Height (mm) 565 Width (mm) 595 Depth (mm) 550 Number of Basket Racks STU Capacity For Feeding-bottle Washing Shelves 4 STU Medical and Surgical Tool (134 C) ~ 60 min Textile Materials (134 C) ~ 60 min Heavy Materials (134 C) ~ 65 min Plastic/Rubber Materials (121 C) ~ 80 min Rubber/Glass (125 C) ~ 60 min Fluids (121 C) ~ 90 min Flash (134 C) ~ 20 min Prion (134 C) ~ 60 min Bowie & Dick Test (134 C) ~ 35 min Vacuum Leakage Test ~ 25 min Number of optional programs 99 P3 P2 NO P1 Program Set Temperature Time ( o C) SET (s) 1 Pre-washing Washing Drying Drying Disinfection Drying P1: WASHING P2: WASHING + DISINFECTION P3: WASHING + DISINFECTION + DRYING P4: DRYING Program Set Temperature Time ( o C) SET (s) Drying P5: SELF-DISINFECTION OF THE DEVICE Set Temperature Time Program ( o C) SET (s) Disinfection STERILIZATION DEVICES STERILIZATION DEVICES 15

10 IV. Laboratory-type Vertical Steam Sterilizer Standards and Directives for Steam Sterilizer General Characteristics Control System Way of use Keypad Printer (Optional) Communication Warning system Data Storage Procedure follow-up/tracing Motility Vapor control Body Cell Jacket Door Panel Coating Piping Cell Polishing Technical Specifications of Vertical Steam Sterilizer Chamber Volume (L) 4,3 PLC processor Full automatic/ buttons and touch screen Touch Screen 40 characters/lines, integrated thermal printer RS232/RS485 Port/USB (Ethernet Optional) Warnings with audiovisual and written messages 200 cycles Analog indicators for the follow-up of Cell, Jacket, Generator and in addition to the Touch Screen Featuring easy orientation with the help of 2 swivel castors and 2 castors with brakes Through pneumatic valves AISI 304 Stainless Steel 3 mm, AISI 316L Stainless Steel 3 mm, AISI 316L Stainless Steel 12 mm, AISI 304 Stainless Steel AISI 304 Stainless Steel Brass, AISI 304 Stainless Steel Sanding, Electro-polishing (Optional) Height (mm) Device Dimensions Width (mm) Depth (mm) Device Weight (kg) Packaging Weight (kg) Generator Power (kw) Generator Volume (L) Standard Programs Medical and Surgical Tool (134 C) ~ 60 min Textile Materials (134 C) ~ 60 min Plastic/Rubber Materials (121 C) ~ 70 min Fluids (121 C) ~ 75 min Flash (134 C) ~ 30 min Prion (134 C) ~ 55 min Bowie & Dick Test (134 C) ~ 35 min Vacuum Leakage Test ~ 20 min Number of optional programs 8 Processing times are load-dependent, and are given as approximate figures. These times cover the entire sterilization process with an average load including the drying stage. Programs can be customized based on the needs of the customer. Installed Power 15 kw, 3 Phase / 400 VAC ±10 15 kw, 3 Phase / 400 VAC ±10 Main Supply Vapor 1/2 Pipe 5 Bars 1/2 Pipe 5 Bars Medical Devices Directive MDD 93/42/EEC / 2007/47/EC Medical Device Class Class IIb, MDD 93/42/EEC, 2007/47/EC (Ek. IX) Low-voltage Directive 2006/95/EC - EN , EN , EN Electromagnetic Compatibility Directive 2004/108/EC EN , EN Pressurized Equipment Directive PED 97/23/EC : EN , -2, -3, -4, -5 Prismatic Steam Sterilizer Standard EN285 Quality Management System 9001 Medical Devices Quality Management System Environment Management System Printer It is possible to follow the parameters below with alphanumerical printer with thermal technology and 40 columns. Organization Device Serial No Device Installation No (is any) - Date and Time Information Device Volume Sequential Sterilization Number - Program Number Pre-vacuum time and Stage Number Pre-heating Time and Stage Number Sterilization Temperature Pressure - Time Drying Temperature - Pressure- Time Possible Error Messages of the System Total Sterilization Time Printer ( optional in vertical steam sterilizer ) Safety and Quality It protects the user against current leaks Short circuit protection Safety Valve HEPA filter for fresh air Water level control with magnetic float within the generator Water level float (in the water tank) (optional) Water vapor evaluation with pneumatic valve Leak Test Password protection Sensor protection against obstacles on the door way Pressurized door locks Safety system in models with double sliding doors to protet opening simultaneously Emergency button Water Vapor Air Test Pressure Test Temperature Operation Temperature Operation Pressure Waste Discharge With metal pipe with at least 2 m inclination (diameter: 2-3 ) Control through the pneumatic valve and software Through the Vacuum Motor (within the device) Chamber 8 bars 148 o C 134 o C 2,4 Bars Generator Test Pressure 8 bars Test Temperature 159 o C Operation Temperature 145 o C Operation Pressure 3,5 Bars Water Level Protection Stainless CRES / AISI 304 (CRES: Anticorrosive Stainless Steel) Electricity Su Energy Consumption 20 kw//cycle ~120 L//Cycle Temperature Range 115 o C o C (Cell) Measurement 3xPT 100 (DIN A Class) Sensor Position Cell (1), Generator (1), Jacket (1) Pressure Measurement Pressure Sensors (6) Sensor Position Chamber (1), Jacket (1), Generator (1), Water (1), Gasket (1), Air (1) Source Pre-vacuum Vacuum Pump with fluid ring (2.2kW) Yes Our Steam Sterilizer are used for sterilization of heat-resistant medical devices and tools with saturated vapor. SLIDING VERTICAL STEAM STERİLİZER FLYWHEEL VERTICAL STEAM STERİLİZER 16 STERILIZATION DEVICES STERILIZATION DEVICES 17

11 ADELA-ELENA series ADELA - ELENA series steam sterilizers are designed and manufactured regarding the manufacturing and product standards. General Characteristics Control System Operation Mod Screen Type Screen Size Keypad Printer Communication Warning Sytem Data Storage Monitoring Mobility Steam Control PLC CPU Fully Automatic / Button Command Color TFT, LCD Touchscreen 7,0 (10,0 optional) Touchscreen 40 Charakcer/Line, Thermal Printer RS 232 Port / USB, (Ethernet optional) Visual & Audio & Printed Up to 200 Cycles Touchscreen, Anaolgue Gauges for Chamber, Jacket, Generator and Air Pressure (Manometer) 4 Easy positioning on 4 swivel castors and firm fixing on slegs with pneumatic valves Safety and Quality Protects operator from electrical current leaks. Short circuit protection. Safety valve. Hepa filter for air filtration. Water level control via buoy in generator. Pneumatic Valves for precise exhausting. Leak test. Password protection. Sensors against obstructions on the doors pathway. Doors locks under pressure. Emergency stop button. Unable to open both doors at once double door models. Standard Programs Medical & Surgical Instruments (134 C) ~ 60 min Textile Materials (134 C) ~ 60 min Rubber Articles (121 C) (121 C) ~ 80 min Liquids in Glass Container (121 C) ~ 60 min Liquids in Glass Container (125 C) ~ 60 min Flash (134 C) ~ 20 min Prion (134 C) ~ 90 min Bowie & Dick Test (134 C) ~ 45 min Vacuum Leak Test ~ 25 min Customizable Program Capacity 99 Relevant Directives and Standards Medical Device Directive MDD 93/42/EEC / 2007/47/EC Sınıf IIb, MDD 93/42/EEC, 2007/47/ Medical Device Class EC (Ek. IX) 2006/95/EC - EN EN Low Voltage Directive EN EMC Directive 2004/108/EC EN EN Pressure Equipments Directive PED 2014/68/EU : EN , -2, -3, -4, -5 Steam Sterilizer Directive EN285 Quality Mangement System 9001 Medical Devices Quality Mangement System Enviromental Management Systems Type tests of Sümer A.S. Steam sterilizers are performed and certified according to the directives of EN 285 and TS EN by The German accreditation company HYGCEN GmbH. 18 STERILIZATION DEVICES STERILIZATION DEVICES 19

12 ADELA-ELENA series Technical Data Sheet Range Temperature 115 o C o C (Chamber) Source Vacuum Pump, Water Ring (2.2kW) Measurement PT 100 (DIN A Class) Pre-Vacuum Yes ChAmbER volume (LItER) AND DImENSIoNS Sensor Position Chamber (1) Device Sonstruction SINGLE DOOR DOUBLE DOOR 250 L 325 L 450 L 580 L 250 L 325 L 450 L 580 L 718 L 900 L Height (mm) Pressure Measurement Pressure Sensores (4) Sensor Position Chamber (1), Jacket(1), Generator (1), Gasket(1) Body Chamber Jacket Door AISI 304 Stainless Steel 40X40X2 mm 6mm, AISI 316 L Stainless Steel 3mm, AISI 316L Stainless Steel 10mm, AISI 304 Stainless Steel Width (mm) Panel Cover Pipes 1-1,5 mm AISI 304 Stainless Steel Brass, AISI 304 Stinless Steel Depth (mm) Chamber Polishing Sandblastin, Electropolishing (Optionel) STU Capacity 1, , overall DImENSIoNS Jacket SINGLE DOOR DOUBLE DOOR 250 L 325 L 450 L 580 L 250 L 325 L 450 L 580 L 718 L 900 L Height (mm) Test Pressure Test Temperature Working Temperature Working Pressure 3,75 Bar 140 o C 134 o C 2,5 Bar Width (mm) Depth (mm) Generator Power (3 Phase/400± 10VAC) Installation Power Generator Volume(L) GENERAtoR SpECIfICAtIoNS SINGLE DOOR DOUBLE DOOR 250 L 325 L 450 L 580 L 250 L 325 L 450 L 580 L 718 L 900 L 30 KW 35 KW 3 Phase / 400 VAC ±10 30 KW 35 KW 3 Phase / 400 VAC ±10 40 KW 45 KW 3 Phase / 400 VAC ±10 40 KW 45 KW 3 Phase / 400 VAC ±10 30 KW 35 KW 3 Phase / 400 VAC ±10 30 KW 35 KW 3 Phase / 400 VAC ±10 40 KW 45 KW 3 Phase / 400 VAC ±10 40 KW 45 KW 3 Phase / 400 VAC ±10 50 KW 55 KW 3 Phase / 400 VAC ±10 50 KW 55 KW 3 Phase / 400 VAC ± Test Pressure Test Temperature Working Temperature Working Pressure Water Level Protection Elektric Water Water Steam Air Generator 5,25 Bar 150 o C 144 o C 3,5 Bar *CRES / AISI 304 SS * CRES: Anti Corrosive Stainless Steel Energy Consumption 20 kw/loop ~120 Lt/Loop Drainage Inclined pipe to be installed onsite with at least 2 m of length (Diameter: 2-3 ) Pneumatic valve, software controlled Vacuum Motor (Built-in) 20 3 STERILIZATION DEVICES STERILIZATION DEVICES

13 WASHER DISINFECTORS

14 Washer Disinfector Our washer disinfectors has been designed to be used for washing and disinfection of heatresistant and reusable medical devices tools. It is used in the following: Hospitals, Outpatient clinics, Rehabilitation centers, It is used in laboratories. It must be used by the expert technical personnel who have completed the required training for washing and disinfection process. Packaging and Loading Packaging material must not be used in washing and disinfection procedure. Instead, a cart and a basket suitable for the materials to be washed. Materials/tools must not be placed one over another or stuffed together when placing them within suitable baskets. Same types of materials must be placed together to the extent possible, and loading cart or racks must be used. Materials that can be subjected to washing and disinfection Programs used and times Surgical tools Operating room containers Laboratory tools Glass containers Rubber materials Plastic materials P3 P2 NO P1 Program Set TEMPERATURE Time ( o C) SET (s) 1 Pre-washing Washing Drying Drying Disinfection Drying P1: WASHING P2: WASHING + DISINFECTION P3: WASHING + DISINFECTION + DRYING P4: DRYING Program Set TEMPERATURE Time ( o C) SET (s) Drying P5: SELF-DISINFECTION OF THE DEVICE Set TEMPERATURE Time Program ( o C) SET (s) Disinfection Control System Way of use Screen Type Screen Dimensions Keypad Printer Communication Warning System General Characteristics Data Storage Procedure Follow-up/ Tracing Mobility PLC Full automatic/ buttons and touch screen Color TFT, Touch LCD 4,5 (7 Optional) Touch Screen Optional (thermal printer with 40 characters/lines) RS 232 Port / USB, Ethernet Warning with audiovisual and written messages 200 cycles Touch screen Easy orientation with 4 swivel castors and stabilization legs with adjustable heights according to the inclination of the floor Structural characteristics Body 1,5 mm, AISI 304 Stainless Steel Cabin 1,5 mm, AISI 316L Stainless Steel Door Tempered Glass or Stainless Steel Panel Coating AISI 304 Stainless Steel Piping Silicone Hose, 1,5 mm, AISI 304 Stainless Steel Chamber Polishing Electro-polishing Supply Water Installed Power L Installed Power L Instant Power L Instant Power L Installation Requirements Deionized water processed with Reverse Osmosis is recommended for high performance. ~ 35kW, 1 Phase, 220 VAC ±10 ~ 35kW, 3 Phase, 380 VAC ±10 ~ 10kW ~ 15kW Water Consumption ~120 L /cycle 24 WASHER DISINFECTORS WASHER DISINFECTORS 25

15 Medical Device Directive Medical Device Class Low-voltage Directive Electromagnetic Compliance Directive Washing and Disinfection Devices Quality Management System Requirements Medical Devices Regulatory Requirements Environment Management System Relevant Directives and Standards MDD 93/42/EEC /47/EC Class 2b, acc. to EC MDD 93/42/ EEC 2007/47/EC (Annex IX) 2006/95/EC EN /108/EC EN EN Series Standards Safety and Quality It protects the user against current leaks. It has short circuit protection. It is equipped with safety valve protection. HEPA filter is used for fresh air. It has password protection. A system preventing the opening of both doors simultaneously is used in models with double doors. An emergency button is provided. Temperature Operation Range 15 o C 110 o C Measurement 3xPT100 (DIN A Class) Sensor Sensor Positions Cabin (2), Water (1) Pressure Measurement 2 Pressure Sensors Sensor Positions Air (1), Washer (1) Technical Data Table Under-The-Desk Washer Disinfector Washer Disinfector Chamber Volume (L) Chamber Width (mm) Chamber Height (mm) Chamber Depth (mm) Width of Device (mm) Height of Device (mm) Depth of Device (mm) Width of Packaging (mm) Height of Packaging (mm) Depth of Packaging (mm) Single Door Double Door Touch Screen RS232 Outlet Water-heating Resistance (kw) Drying Resistance (kw) Drying Motor Fan Blowing Flow Rate (m3/h) AUTOMATIC SLIDING DOOR WashER DISINFECTOR Under-the-Desk Washer Disinfector Cabin of the washer disinfector is manufactured from high-quality chromiumnickel in compliance with national and international standards, and the required leakage test have been carried out. Immersion-type stainless steel heaters have been used to ensure the temperature in the washing and disinfection device cabin reach the set temperature value. The cabin has been insulated with mineral wool cabin mm in thickness. A stable protective coating have been provided outside the insulation. MANUAL DOOR WashER DISINFECTOR Electric Jeating Power (kw) Circulation Pump Power (kw) Electrical connection characteristics of the circulation pump Circulation Pump Flow Rate (d/d) 0,6 0,6 0,6 0,6 1,37 1,37 1,37 1,37 1,37 1, V 50 Hz 220 V 50 Hz 220 V 50 Hz 220 V 50 Hz 220 V 50 Hz 220 V 50 Hz 220 V 50 Hz 380 V 50 Hz 380 V 50 Hz Detergent Dosage Pump Neutralizing Agent Dosage Pump Electric Connection Water Draining Pipe Diameter (mm) P+N 50 Hz, 230 VAC 1P+N 50 Hz, 230 VAC 1P+N 50 Hz, 230 VAC 1P+N 50 Hz, 230 VAC 1P+N 50 Hz, 230 VAC 3N+1 50 Hz, 380 VAC 3N+1 50 Hz, 380 VAC 3N+1 50 Hz, 380 VAC 3N+1 50 Hz, 380VAC 380 V 50 Hz 3N+1 50 Hz, 380 VAC Number of Racks in the Basket DIN Basket (piece) HEPA Filter H14, Particle Holding Ratio %99,999 It is equipped with printer, oil dosage pump, disinfectant dosage pump and air spray optionally UNDER THE-DESK WashER DisinfecTOR Materials/tools must not be placed one over another or stuffed together when placing them within suitable baskets. Irregular placement of materials will prevent proper cleaning. As a result, sterilization quality will be affected also. 26 WASHER DISINFECTORS WASHER DISINFECTORS 27

16 WD series Our product has been designed to be used for washing and disinfection of heat-resistant and reusable medical devices tools. It is used in the following: Hospitals, Outpatient clinics, Rehabilitation centers, It is used in laboratories. It must be used by the expert technical personnel who have completed the required training for washing and disinfection process. Packaging and Loading Packaging material must not be used in washing and disinfection procedure. Instead, a cart and a basket suitable for the materials to be washed. Materials/tools must not be placed one over another or stuffed together when placing them within suitable baskets. Same types of materials must be placed together to the extent possible, and loading cart or racks must be used. Materials that can be subjected to washing and disinfection Programs Used and Times Surgical tools Operating room containers Laboratory tools Glass containers Rubber materials Plastic materials P3 P2 NO P1 Program Set TEMPERATURE Time ( o C) SET (s) 1 Pre-washing Washing Drying Drying Disinfection Drying P1: WASHING P2: WASHING + DISINFECTION P3: WASHING + DISINFECTION + DRYING P4: DRYING Program Set TEMPERATURE Time ( o C) SET (s) Drying P5: SELF-DISINFECTION OF THE DEVICE Set TEMPERATURE Time Program ( o C) SET (s) Disinfection General Characteristics Control System PLC Way of use Full automatic/ buttons and touch screen Screen Type Color TFT, Touch LCD Screen Dimensions 7 Keypad Touch Screen Printer Thermal printer with 40 characters/ lines Communication RS 232 Port / USB, Ethernet Warning System Warning with audiovisual and written messages Data Storage 200 cycles Procedure Follow-up/ Tracing Touch screen Mobility Water Consumption Easy orientation with 4 swivel castors and with adjustable heights According to the inclination of the floor ~120 L /cycle Structural Characteristics Body 2,5 mm, AISI 304 Stainless Steel Cabin 1,5 mm, AISI 316L Stainless Steel Door Tempered Glass Panel Coating 1,5 mm, AISI 304 tainless Steel Piping Silicone Hose, 1,5 mm, AISI 304 Stainless Steel Chamber Polishing Electro-polishing Supply Water Installed Power 135 L Installed Power L Instant Power L Instant Power L Installation Requirements Deionized water processed with Reverse Osmosis is recommended for high performance. ~ 20kW, 1 Faz, 230 VAC ±10 ~ 35kW, 3 Faz, 380 VAC ±10 ~ 10kW ~ 15kW 28 WASHER DISINFECTORS WASHER DISINFECTORS 29

17 Medical Device Directive Medical Device Class Low-voltage Directive Electromagnetic Compliance Directive Washing and Disinfection Devices Quality Management System Requirements Relevant Directives and Standards MDD 93/42/EEC /47/EC Class IIb, acc. to EC MDD 93/42/ EEC 2007/47/EC (Annex IX) 2006/95/EC EN /108/EC EN EN Series Standards 9001 Medical Devices Regulatory Environment Management System Safety and Quality It protects the user against current leaks. It has short circuit protection. It is equipped with safety valve protection. HEPA filter is used for fresh air. It has password protection. A system preventing the opening of both doors simultaneously is used in models with double doors. An emergency button is provided. Temperature Operation Range 15 oc 110 oc Measurement 3xPT100 (DIN A Class) Sensor Sensor Positions Cabin (2), Water (1) Pressure Measurement 2 Pressure Sensors Sensor Positions Cabin (1), Air (1) NEW SERIES Technical Data Table Chamber Volume (L) Chamber Width (mm) Chamber Height (mm) Chamber Depth (mm) Width of Device (mm) Height of Device (mm) Depth of Device (mm) Width of Packaging (mm) Height of Packaging (mm) Depth of Packaging (mm) Single Door Double Door Touch Screen RS232 Outlet Water-heating Resistance (kw) 7,5 kw 7,5 kw 7,5 kw 10 kw 10 kw Drying Resistance (kw) 6 kw 6 kw 6 kw 8 kw 10 kw Drying Motor Fan Blowing Flow Rate (m3/h) 150 m 3 /h 150 m 3 /h 150 m 3 /h 250 m 3 /h 250 m 3 /h Electric Jeating Power (kw) 7,5 kw 7,5 kw 7,5 kw 12.5 kw 15 kw Circulation Pump Power (kw) 0.9 kw 1.1 kw 1.1 kw 2.4 kw 2.2 kw Electrical connection characteristic of The circulation pump 1 Faz, 230 VAC ±10 3 Faz, 380 VAC ±10 1 Faz, 230 VAC ±10 3 Faz, 380 VAC ±10 3 Faz, 380 VAC ±10 3 Faz, 380 VAC ±10 3 Faz, 380 VAC ±10 Circulation Pump Flow Rate (L/min) 650 L/dk 650 L/dk 650 L/dk 880 L/dk 650x2=1300 L/dk Detergent Dosage Pump Neutralizing Agent Dosage Pump For detailed information please contact us Electric Connection 3N+1 50 Hz, 380 VAC 3N+1 50 Hz, 380 VAC 3N+1 50 Hz, 380 VAC 3N+1 50 Hz, 380 VAC 3N+1 50 Hz, 380 VAC Water Draining Pipe Diameter (mm) 1 AISI AISI AISI AISI AISI 304 Number of Racks in the Basket Washing Solutions DIN Basket (piece) HEPA Filter H14, Particle holding ratio %99,999 It is equipped with printer, oil dosage pump, disinfectant dosage pump and air spray optionally Materials/tools must not be placed one over another or stuffed together when placing them within suitable baskets. Irregular placement of materials will prevent proper cleaning. As a result, sterilization quality will be affected also. Neutralizing agent ALKALINE Lubricant 30 WASHER DISINFECTORS WASHER DISINFECTORS 31

18 GENERAL SURGERY OPERATION TABLES

19 I. General Surgery Operation Table series Our Operation Tables; Have been designed to be used by trained, certificated and formally assigned hospital personnel or other authorized persons and have been produced to be used in in all the surgical operations on patients including orthopedic procedures, gynecologic or urologic procedures in healthcare facilities. Easy-to-use and ergonomic design suitable for General Surgery procedures Design to provide the safety of the patient and the operation team Possibility of ensuring the silent and no-vibration up and down, back piece, Trendelenburg and reverse Trendelenburg, right and left, lateral and horizontal back and forth (sliding) movements of the table using the hand control Possibility of manual foot piece movements with the help of gas spring Mechanical usage in head section Electro-hydraulic power control system Design suitable for various patient positions and movements of the X-Ray devices with C-arms A rail system for fixing and tightening of all the accessories Possibility of positioning the table parallel to the floor (except for the head and foot pieces) by pressing one key on the hand control Possibility of saving the required positions in the memory Radiographic tabletop set made from compact laminate material The spare control system on the table body Easy use under fluoroscopy Possibility of fixing the foot piece in place of the head piece The mattress on the table is made from multi-layer visco material and is antistatic, impermeable for fluids and antibacterial with a thickness of 60 mm It is impermeable against any and all fluids including blood Possibility of use for min 60 minutes (capability of 200 movements in the average) in case of power failure thanks to the rapidly charging and no-maintenance battery system (12 A/hr- 24 VDC) Possibility of flex and re-flex movements with one key on the hand control The upper supporting panel is made from aluminum, body and lower coating is made from AISI 304 quality stainless steel, the lower panel and the bearing body is made from GGG 40 material A silent and no-vibration electro-hydraulic motor system has been provided to ensure movements allowing various patient positions. Featuring the fixation on the floor on four points with the help of electro-hydraulic pistons controlled by the hand control and the controls on the body Possibility of being lowered down to minimum 530 mm (mattress excluded) and being raised up to maximum 1000 mm Stand-by feature when the table is not in use. Possibility of showing the movements of the table on the LCD screen of the hand control In addition, backlighting for the keys on the hand control 34 GENERAL SURGERY OPERATION TABLE GENERAL SURGERY OPERATION TABLE 35

20 Weight and Dimensions Positions and Limits Ambient Conditions Table Mattress Table pieces 5 pieces Height (min/max) no-mattress mm Standard Head piece Back piece Kidney Elevator (optional) Seat 236x520 mm 480x520 mm 120x620 mm 580x520 mm Head piece (Up/down) 90 / 90 Back piece (Up/down) 75 / 30 Leg piece (Up/down) 30 / 90 Tilting of the Leg piece 90 The mattress is made from multi-layer visco material, and is antistatic, fluid-impermeable and antibacterial, and is 60mm thick. Leg piece 240x605 mm Flex/Reflex 210 / 100 Ambient Temperature: must be in 10 C - 40 C range. Optional Length Width (Rails included) Width (Rails excluded) Weight Bearing Capacity Floor Range 2000 mm 572 mm 520 mm 280 Kg 400 Kg 32 mm Trendelenburg/Reverse Trendelenburg 30 / 30 Tilting of the upper panel (right/left) 22 / 22 Horizontal sliding feature (Sliding) 360 mm Kidney Elevator, optional 120 mm Thorax Elevator, optional 100 mm Floor Range 32 mm Humidity: must be in 30% - 5% range. Pressure: 0,7 1,06 bars 80 mm, soft upper panel made from visko material, polyurethane middle panel, rubber base, waterproof, antibacterial, antistatic, fixed onto the table with velcro bands. Electrical Characteristics Model Characteristics Protection Class IPX4 Protection Class 230 VAC Hz Electrical Protection Class 1 Insulation Class Tip BF, IEC Battery It is charged rapidly and required no maintenance Charging voltage 24 VDC Capacity 12 A/h Possibility of use for min. 60 minutes (200 movements) Zeroing Obese FOOT piece hydraulic MOVEMENTS SLIDLING MOVEMENT TRENDELEN- BURG FLEX TILT HyDRAULIC locking system BACK piece Adela 6M Adela 7M Adela 5M Adela WIDE Down UP Adela WIDE cm lowering feature 53 cm 36 GENERAL SURGERY OPERATION TABLE GENERAL SURGERY OPERATION TABLE 37

21 FLEX 210 o REFLEX 100 o REVERSE TRENDELENBURG 30 o TRENDELENBURG 30 o Maximum Movement Capability Best performance FOOT PIECE DOWN 90 o FOOT PIECE UP 30 o BACK PIECE DOWN 30 o BACK PIECE UP 75 o MINIMUM HEIGHT 530 mm MAXIMUM HEIGHT 1000 mm LEFT 22 o RIGHT 22 o SLIDING 360 mm 38 GENERAL SURGERY OPERATION TABLE GENERAL SURGERY OPERATION TABLE 39

22 WARMING CABINETS KAN SAKLAMA DOLAPLARI

23 The warming cabinets have been designed to bring the surgical fluids and solutions and or blankets, bags, solutions in plastic and glass containers to the temperature levels required for the applications in the hospital and ambulatory treatment venters. Device Capacities (L) General Characteristics The device consists of internal and external surfaces made from stainless steel The door consists of heat-resistant double glass, and can be made from stainless steel optionally Walls and doors of the device have double layers, and the wall thickness of walls vary between 20 and 25mm depending on the thickness of the material Air circulation is distributed homogenously with a fan It is equipped with 4 types of user-friendly control systems selected within the ordering process The upper and single divisions contain the key for switching between I.V. fluids and IRA/Blankets and control to keep the temperature in the range of C or C. The temperature selection for lower divisions is between 32 and 71.1 C Any error occurring in the device is shown on the digital screen The device will produce audiovisual warning when the set temperature exceeds 5.5 C (± 0.5 C) and turns the heater off automatically The double cabin control system controls the cabins and the temperatures of both cabins. Upper and lower cabins can operate at different temperatures Indicators on the Control Panel Digital temperature indication The temperature adjustment buttons: buttons for selection of irrigation, blanket and solutions Off/on button for divisions Temperature error indicator, door status indicator Indicator that controls the temperatures of divisions actively Possibility of the required temperature through the control panel, selection of the required operation temperature program Optional Control Systems Heating between 32 C and 94 C is possible Possibility of connection to a computer and recording the temperature values through the USB connection Membrane digital screen control system silver Membrane digital screen control system diamond (with keypad) Membrane digital screen control system diamond (with keypad) Mechanical or electronic door locking system with single- or double-door cabin characteristics It is suitable for use where materials brought to predetermined temperatures must be used in some surgical, obstetrics, emergency or clinical instances. The internal structure of the device allows the simultaneous heating of blankets, linen, and solutions for irrigation and sterile surgical solutions. It can be used to heat pouches and solutions packaged in plastic or glass materials. A fan is provided within the device to ensure homogeneous air circulation within the device. The ventilation channels and fan protection grids within the device are made from inflammable material. 42 WARMING CABINETS WARMING CABINETS 43

24 NEONATAL PRODUCTS I. Mother Milk Refrigerators II. Mother Milk Freezers III. Mother Milk Refrigerator and Freezers IV. Baby Bottle V. Injector Heater VI. Baby Bottle and Injector Heater KAN SAKLAMA DOLAPLARI

25 I. Mother Milk Refrigerators II. Mother Milk Freezers III. Mother Milk Refrigerator and Freezers This device produced by Sümer A.Ş. ensures storage and freezing of breast milk without losing its nutritional value particularly in hospitals, neonatal intensive care units and gynecology and obstetrics units. General Characteristics MOTHER Milk REFRIGERATORS: Operation in 0 C / 10 C range, and fixing at + 4 C Mother Milk Freezers: Operation in -25 C / 0 C range, and fixing at -20 C Mother Milk REFRIGERATor and FREEZERS (Combined System): Operation in the range of 0 C / 10 C and fixing at + 4 C in the storage section, and operation in the range of -25 C / 0 C and fixing at, -20 C in the freezing section PLC control system Stainless steel internal and external materials Three-layer glass door for perfect insulation Lockable door with magnetic gasket Alarm Systems: Low and high temperature, power failure and temperature sensor failure, audiovisual alarm system for the door left open Alarm system is fed by the battery that is charged automatically Lighting controlled with one single key on the indicator panel Insulation with injected high-density polyurethane Mobile rack system with special divisions made from stainless steel Housings for feeding bottles and milk pouches for storage on racks Special lighting system Optional Optional RS 232 / RS 485 outlet Optional remote alarm system Optional remote control MOTHER MILK FREEZERS -20 o C MOTHER MILK REFRIGERATOR AND FREEZERS -20 o C +4 o C MOTHER MILK REFRIGERATORS +4 o C 46 NEONATAL PRODUCTS NEONATAL PRODUCTS 47

26 IV. Baby Bottle Heater V. Injector Heater VI. Feeding Bottle and Injector Heater The device ensures the safe heating of the breast milk and baby food taken out from the freezer or deep freezer or kept at room temperature or keeping them at the set temperature. The device is designed for infants fed through injectors. Reliable Quality Cutting edge Minimum energy consumption by cutting in and out with very short intervals during the operation Featuring operation with dry system Featuring continuous operation for 24 hours at the set ideal feeding temperature Featuring keeping the temperature fixed when the set temperature is reached Heating chamber made from aluminium Removable Baby Bottle divisions BABY BOTTLE HEATER Minimum energy consumption by cutting in and out with very short intervals during the operation Featuring operation with dry system Featuring continuous operation for 24 hours at the set ideal feeding temperature Featuring keeping the temperature fixed when the set temperature is reached Heating chamber made from aluminum Removable Baby Bottle divisions It is produced with 30 injector capacity. The standard injector volume distribution of the injector heater is as follows: For Baby Bottle with volumes between 80 ml and 150 ml 12 Baby Bottles, 24 Baby Bottles, 30 Baby Bottles, Optional Optional ml Feeding Bottle capacity, Optional digital temperature indicator and temperature setting button, Optional door addition feature. Optional production aüü Feeding Bottle size is possible. 10 pieces 5-ml injectors 10 pieces 10-ml injectors 10 pieces 20-ml injectors Injector volume distribution can be changed optionally BABY BOTTLE AND INJECTOR HEATER (Combined System) INJECTOR HEATER It is designed for heating the mother milk or baby food taken out from the refrigerator to temperatures suitable for feeding the babies and keeping them at that temperature, and have been manufactured to buy time for personnel working in the unit. It is use with the purpose of heating the food stuff such as mother milk or baby food before feeding them to the baby to a certain temperature (36-38 C) within injectors in neonatal units to babies without sucking function or in intensive care units where it is not possible to take babies out. 48 NEONATAL PRODUCTS NEONATAL PRODUCTS 49

27 BLOOD BANK REFRIGERATORS KAN SAKLAMA DOLAPLARI

28 SM-KSD series Blood Bank Refrigerator have been designed so as to be compliant with standards related to production and products. It is used to keep blood at +4 o C (±2 o C) in hospitals And blood storage banks. General Characteristics Control System Way of use Screen Type Screen Dimensions Keypad Printer Communication Warning system Data Storage Procedure follow-up/tracing Motility Door characteristics Door Safety System Fan characteristics Operation Range Lighting Castor System Alarm System Rack characteristics Material characteristics Insulation Power value PLC processor, Electronic card Full automatic/ buttons and touch screen (Monochrome screen, optional) Color TFT, Touch screen LCD 4,3 (Optional screens with different dimensions are also possible.) Touch 40 characters/lines, integrated thermal printer (Optional) RS485 Port/USB (Ethernet Optional) Warnings with audiovisual and written messages Data of 30 days Touch Screen Easy orientation on 4 swivel castors Single door, temperature-insulated, does not cause vaporization or humidity, contains tempered glass and magnetic gasket Magnetic lock system, featuring the possibility of opening through the touch screen with or without password It provides homogeneous air. Fan protection grids are made from non-flammable material 4 O C ± 2 O C Automatic lightening upon opening of the door with LED-type bulbs resistant against wide ranges, featuring the possibility of turning the lights on also when the door is open through the touch screen It is equipped with four castors, out of which two have brakes The device is capable of producing both audio and visual alarms Mobile racks made from AISI 304 quality stainless steel All the internal and external fixtures of the device are made from AISI 304 quality stainless steel Polyurethane material 40 mm in thickness has been used 220 V/50 Hz Relevant Standards and Directives Medical Device Directive MDD 93/42/EEC / 2007/47/EC Medical Device Class Class IIa, MDD 93/42/EEC, 2007/47/EC (Encl. IX) Low-voltage Directive 2006/95/EC - EN Electromagnetic Compatibility Directive 2004/108/EC EN /108/EC EN Medical Devices Quality Management System Environment Management Quality System All the racks are removable to ensure easy placement and removal of materials in and out the blood bank refrigerator. You can remove any of the divisions with the purpose of larger bottles. 52 BLOOD BANK REFRIGERATORS BLOOD BANK REFRIGERATORS 53

29 Internal Volume Dimensions Placement of blood pouches Device Model Cell Volume (L) Height (mm) Width (mm) Depth (mm) You can place 24 pouches in each of the 24 divisions by placing with openings facing different directions in turn. You can place 120 bottles/pouches on 5 racks. Bottles with long necks must be placed in lower divisions to avoid obstacles on the door way. High Technology Superior performance Device Dimensions Tips and recommendations related to placement Device Model Cell Volume (L) Height (mm) Width (mm) Depth (mm) Bottles in the upper divisions right below the lights are exposed to temperatures very slightly higher when lights are on. Place blood pouches accordingly, and remember to turn the lights off the device will not be in use for long while. Place the blood pouches assigned for daily use in the front parts of divisions so that the labels will be read easily. Place the blood pouches assigned for use after a while at the back parts. Do not let children to climb on the divisions of the device, to step on them, or to hang on them. These can result in serious injuries or serious damage on the device. CLASS SYMBOL MEAN AMBIENT TEMPERATURE (+ C) Very Temperate SN Temperate N Subtropical ST Tropical T Glass screen with special design Touch screen keypad Audio alarm feature Special door system operating with a password Changeable screen color Ambient temperature for the operation of the device must be between 10 o C and 40 o C, and the ambient humidity must be maximum 70%. 54 BLOOD BANK REFRIGERATORS BLOOD BANK REFRIGERATORS 55

30 STAINLESS HOSPITAL EQUIPMENTS KAN SAKLAMA DOLAPLARI

31 Material admission and pre-washing desk (Surgical tool washing sink) It is produced with one, two or three sinks It is made from AISI 304 Quality 18/8 CrNi stainless steel Manufacturing is carried out according to dimensions in the prepared architectural projects Work Table The table is manufactured as movable or fixed as an option The work table is manufactured with single or double doors as an option Pre-washing desk with ultrasonic washer (surgical tool washing sink) One ultrasonic washing sink is provided It is made from AISI 304 Quality 18/8 CrNi stainless steel Manufacturing is carried out according to dimensions in the prepared architectural projects Closed Transfer Cart It is designed for carrying materials in Sterilization It is suitable for the transfer of containers or other materials Air/water Gun It is designed as pressurized air or pressurized water gun It can be used to clean the insides of the tools with lumens It can resist pressures up to 6 bars Work table with cupboards and drawers The table is provided with 4 drawers Cupboards with racked are provided at sides 58 STAINLESS HOSPITAL EQUIPMENTS STAINLESS HOSPITAL EQUIPMENTS 59

32 Material Transfer Cart/ Tool Table The card has two racks It has a handle at the side for pushing Hand-washing sink for doctors with photocell It is manufactured as single, double or triple hand-washing sinks Water control system has photocell The soap-holder is either controlled with the elbow or includes photocell Stainless Wire Baskets They are made from Stainless Steel wire frame and braided wire Baskets can be manufactured with covers Hand-washing sink for doctors with knee control It is manufactured as single, double or triple hand-washing sinks Water control system is controlled with the knee The soap-holder is either controlled with the elbow or includes photocell Wire Racks They are portable. Distances between racks are adjustable Racks are gridded It is manufactured with three, four or five racks Operation Room Closet (for tools and drugs) It has a closet at the upper part with two glass doors and three racks It has two drawers and a closet with two doors at the lower part Steel Racks Racks are manufactured as plain panels or with holes It is manufactured with three, four or five racks The rack system is portable STAINLESS HOSPITAL EQUIPMENTS STAINLESS HOSPITAL EQUIPMENTS

33 Hygiene Closet (Closet for shoe-covers, bonnets-masks) It has three or six divisions for separate placement of shoe-covers, bonnets-masks There is a division for contaminated wastes at the lower part that can be opened easily Tool Table (with back part) Three edges of the table has barriers 4 cm in height A rack for materials has been placed underneath Mayo Table Hydraulic Up and down movements are possible through the hydraulic system It can be adjusted to heights between 850 to 1200 mm Drug and Material Cart It has one cupboard and 6 drawers Slipper Cart The rack system is produced with a capacity of 24 or 20 couples of slippers It is mobile. It can be produced to be fixed as an option Eskoba (Steps) It is manufactured with one or two steps 62 STAINLESS HOSPITAL EQUIPMENTS STAINLESS HOSPITAL EQUIPMENTS 63

34 Hygiene Closet (Closet for Shoe-covers Bonnets - Masks) The cart is manufactured to be used during wound dressing. The upper pane includes Bottle Holders for solutions. It has five drawers and a 12-liter waste bucket. Wound dressing cart (With cupboard) With inclined washing surface The upper pane includes Bottle Holders for solutions The wound dressing card has 3 drawers and 2 cupboards Corps Washing Table With inclined washing surface It has portable shower faucet 64 STAINLESS HOSPITAL EQUIPMENTS 65

35 Certificates and Brand Registry Documents We believe that the way to the summit passes through high-quality and reliable manufacturing