SINGLE PATIENT DIALYSIS MACHINE

OPERATION MANUAL SINGLE PATIENT DIALYSIS MACHINE SURDIAL Manufacturer NIPRO CORPORATION 3-9-3, Honjo-Nishi, Kita-Ku, OSAKA 531-8510, JAPAN PHONE +81-6-6372-2331 Version No.0R1121-0801

PREFACE Thank you for purchase of Single Patient Dialysis Machine, SURDIAL. The Operation Manual is intended to be prepared for correct and safe use of the machine and not to be intended for description how to manage patient medically. Be familiar with features of the machine and instructions how to operate it contained in this manual before use. Description in this manual is protected by copyright of the manufacturer. Copy, reproduction or preparation of version in any foreign language of the description partially or wholly shall not be allowed without obtaining prior approval by the manufacturer. The life time of this machine is 7 years. Machine description Single Patient Dialysis Machine, SURDIAL Life time 7 years PREFACE

Revision table of SURDIAL OPERATION MANUAL We revised the following contents in operation manual. Kindly refer the following contents in operation manual compare as manual from your side. Page Contents Revision Previous 11-1 11.1.1.Cleaning and disinfection of machine enclosure Delete cleaning procedure using alcohol. Remove blood and/or organic substances from the machine enclosure using soft cloth wetted with tepid water or water. DO NOT use organic solvents such as thinner and benzene to prevent patient damage. Remove blood and/or organic substances from the machine enclosure using soft cloth wetted with alcohol or water. DO NOT use organic solvents such as thinner and benzene to prevent patient damage. 11-1 11.1.2.Cleaning and disinfection of dialysate concentrate connectors and rinse ports Delete cleaning procedure using alcohol. After long term use of dialysate concentrate connectors and rinse ports, solutes in the concentrates may isolated to form harmful crystals and may cause the machine failure. Clean them using cloth wetted with tepid water or water regularly. Pull out the ports to this side to allow easy cleaning. After long term use of dialysate concentrate connectors and rinse ports, solutes in the concentrates may isolated to form harmful crystals and may cause the machine failure. Clean them using cloth wetted with alcohol or water regularly. Pull out the ports to this side to allow easy cleaning. 21-3 21.2.1.Dialysate flow UFR is 2.70L/h when dialysate flow rate is 300mL/min. UFR is 4.00L/h when dialysate flow rate is 30L/min. 0R1A01-0105

PREFACE CONTENTS CAUTIONS FOR SAFETY CAUTION-1~6 1. INTENDED USE 1-1~2 2. CONTRAINDICATION 2-1~2 3. CAUTIONS 3-1~2 4. DEFINITIONS 4-1~4 5. SYMBOL FOR SAFETY 5-1~2 6. INSTALLATION 6-1~12 6.1. Installation environment 6-1 6.1.1. Ambient conditions 6-1 6.1.2. Power supply 6-1 6.1.2.1. When machine power rating is AC 230V 6-1 6.1.2.2. When machine power rating is AC 100V 6-1 6.1.3. Necessary space requirements to use the machine 6-2 6.1.4. Water supply and drainage conditions 6-2 6.1.4.1. Water supply pressure 6-2 6.1.4.2. Water supply flow rate 6-2 6.1.4.3. Water supply temperature 6-2 6.1.4.4. Water quality 6-2 6.1.4.5. Concentrate line pressure 6-3 6.1.4.6. Drainage 6-3 6.2. Unpacking and check of contents 6-4 6.3. Procedure for assembling 6-6 6.3.1. Cautions 6-6 6.3.2. Attachment of I.V. pole, hanger and main lamp 6-6 6.3.3. Connector for each concentrate container 6-7 6.4. Procedures for tube and plug connections 6-8 6.4.1. Connections of fluid supply and drain lines, coupler and power plug 6-8 6.4.1.1. Connection of dialysate coupler tubes 6-8 6.4.1.2. Connections of drain port of machine side 6-8 6.4.1.3. Connection of water supply port 6-8 6.4.1.4. Connection of power plug 6-8 CONTENTS-1

6.4.2. Connection of each concentrate 6-9 6.4.2.1. Connection to execute dialysis operation(before blood line connection) 6-9 6.4.2.2. Connection for water rinsing 6-9 6.4.2.3. Connection for disinfection 6-9 6.4.2.4. Connection for acetic acid rinsing (when acid rinse option is not used) 6-10 6.4.2.5. Connection for acetic acid rinsing (when acid rinse option is used) 6-10 6.4.2.6. Connection for automatic rinsing (1 or 2)(when acid rinse option is used) 6-10 6.4.3. Air purge 6-11 6.5. Disinfection of the dialysate circuit 6-12 6.6. Disposal of used machine 6-12 6.7. Disposal of used packaging materials 6-12 6.8. Disposal of blood lines and dialyzer 6-12 7. MAIN FUNCTIONS AND COMPONENTS 7-1~2 8. CONSTRUCTION OF MACHINE 8-1~14 8.1. Overall construction 8-1 8.1.1. Overall views 8-1 8.1.2. Components of machine and their purposes and functions 8-3 8.2. Operation panel 8-5 8.2.1. Construction of operation panel 8-5 8.2.2. Components of operation panel and their purposes and functions 8-6 8.3. Blood line setting panel 8-9 8.3.1. Construction of blood line setting panel 8-9 8.3.2. Components of blood line setting panel and their purposes and functions 8-10 8.4. Power box 8-11 8.4.1. Construction of power box 8-11 8.4.2. Components of power box and their purposes and functions 8-12 8.5. Main lamp assembly 8-13 8.5.1. Construction of main lamp assembly 8-13 8.5.2. Components of main lamp assembly and their purposes and functions 8-14 CONTENTS-2

9. DISPLAY 9-1~18 9.1. Layout of display 9-3 9.2. Wake up screen 9-5 9.3. Rinse screen 9-6 9.3.1. Rinse menu 9-6 9.3.2. Rinse wait 9-7 9.3.2.1. RINSE1: WATER 9-7 9.3.2.2. RINSE2:CHEMICAL 9-7 9.3.2.3. RNSE3:AUTO1 C&D 9-7 9.3.2.4. RINSE4: AUTO2 C&D 9-8 9.3.3. Rinse execution 9-9 9.3.3.1. RINSE1: WATER 9-9 9.3.3.2. RINSE2: CHEMICAL 9-9 9.3.3.3. RINSE3: AUTO1 C&D 9-9 9.3.3.4. RINSE4: AUTO2 C&D 9-9 9.3.4. Rinse end 9-10 9.3.4.1. RINSE1: WATER 9-10 9.3.4.2. RINSE2:CHEMICAL 9-10 9.3.4.3. RINSE3:AUTO1 C&D 9-10 9.3.4.4. RINSE4:AUTO2 C&D 9-10 9.4. Dialysis screen 9-11 9.4.1. Dialysis 9-11 9.4.2. Priming 9-12 9.4.3. Test mode 9-13 9.5. Setting screen 9-14 9.6. Setting screen 9-15 9.7. Maintenance menu screen 9-16 9.8. Alarm screen 9-17 10. ALARM FUNCTIONS AND RESETTING 10-1~14 10.1. Description of alarms 10-1 10.1.1. Functions when error is alerted 10-1 10.1.2. Procedure for resetting 10-2 10.1.3. Actions to respond to alarm (flow) 10-2 10.2. Table of alarms 10-3 10.2.1. Meanings of terms contained in Table of alarms 10-3 10.2.2. Table of alarms 10-3~14 CONTENTS-3

11. CLEANING AND DISINFECTION 11-1~8 11.1. Cleaning and disinfection of machine outside 11-1 11.1.1. Machine enclosure 11-1 11.1.2. Dialysate concentrate connectors and rinse ports 11-1 11.2. Cleaning and disinfection of fluid lines 11-1 11.3. Disinfection of fluid line inside 11-2 11.3.1. Concentration of disinfectant concentrate 11-2 11.3.2. Diluted disinfectant concentration and disinfection time 11-2 11.3.3. Method to set dilution rate of disinfectant concentrate 11-3 11.3.4. Check of residual disinfectant 11-3 11.4. Removal of calcium deposit from fluid line inside 11-4 11.4.1. Concentration of acetic acid concentrate 11-4 11.4.2. Diluted disinfectant concentration and disinfection time 11-4 11.4.3. Concentration of acetic acid to be diluted 11-4 11.4.4. Method to set dilution rate of acetic acid concentrate 11-5 11.4.5. Check of residual acetic acid 11-5 11.5. Removal of protein deposit from fluid line inside 11-6 11.5.1. Concentration of sodium hypochlorite 11-6 11.5.2. Diluted disinfection concentration and disinfection time 11-6 11.5.3. Concentration of sodium hypochlorite to be diluted 11-7 11.5.4. Check of residual sodium hypochlorite 11-7 12. PROCESS FLOW 12-1~4 12.1. Process flow 12-1 12.2. Description of process flow 12-2 12.2.1. Rinse wait process 12-2 12.2.2. Rinse process 12-2 12.2.2.1. Water rinse mode 12-2 12.2.2.2. Disinfection/rinse mode 12-2 12.2.2.3. Acid rinse mode 12-2 12.2.2.4. Dwelling mode 12-2 12.2.2.5. Prerinse mode 12-2 12.2.3. Rinse end process 12-3 12.2.4. Dialysis wait process 12-3 12.2.5. Preparation process 12-3 12.2.6. Preparation end process 12-3 12.2.7. Dialysis process 12-3 12.2.8. Recovery process 12-3 12.2.9. Air purge process 12-3 CONTENTS-4

13. OPERATION OF MACHINE 13-1~4 13.1. Check and action before turning on power breaker 13-1 13.2. Procedures for machine operation 13-3 13.2.1. Machine SW ON 13-3 13.2.2. Prerinse 13-3 13.2.3. Dialysis 13-4 13.2.4. Postrinse 13-4 13.2.5. Machine power breaker OFF 13-4 14. RINSING 14-1~6 14.1. Selection of rinsing mode 14-2 14.2. Setting of rinsing pattern (example: RINSE4 (AUTO2 C&D) 14-2 14.3. Connection of concentrates 14-3 14.3.1. Connection of concentrates when acid rinse port (option) is not used 14-3 14.3.1.1. Connection at water rinse 14-3 14.3.1.2. Connection at disinfection/rinse 14-3 14.3.1.3. Connection at acid rinse 14-3 14.3.2. Connection of concentrates when acid port unit (option) is used 14-4 14.3.2.1. Connection at water rinse 14-4 14.3.2.2. Connection at disinfection/rinse 14-4 14.3.2.3. Connection at acid rinse 14-4 14.3.2.4. Connection at auto rinse 1 or 2 14-4 14.4. Start of rinsing (example: RINSE4(AUTO2 C&D) 14-5 14.5. Completion of rinsing 14-5 14.6. Discontinuance of rinsing 14-6 15. DOUBLE NEEDLE DIALYSIS 15-1~20 15.1. Setting of dialysate related parameters 15-2 15.1.1. Setting of dialysis mode 15-2 15.1.2. Setting of dialysate concentration 15-2 15.1.2.1. Bicarbonate dialysate 15-2 15.1.2.2. Acetate dialysate 15-3 15.1.3. Setting of dialysate temperature 15-3 CONTENTS-5

15.2. Connection of concentrates 15-4 15.2.1. Connection of concentrates to prepare bicarbonate dialysate 15-4 15.2.2. Connection of concentrate to prepare acetate dialysate 15-4 15.3. Setting of blood line, dialyzer and syringe 15-5 15.3.1. Setting of blood line 15-5 15.3.2. Setting of dialyzer 15-5 15.3.3. Setting of syringe 15-5 15.3.4. Setting of syringe pump 15-5 15.3.4.1. Setting of cross-section ratio of syringe 15-5 15.3.4.2. Setting of syringe operation stop time 15-7 15.3.4.3. Setting of fast-forward volume 15-7 15.4. Preparation of machine (preparation process) 15-8 15.5. Check of preparation completion of machine (preparation end process) 15-8 15.6. Priming process 15-9 15.6.1. Setting of saline vial 15-9 15.6.2. Priming of saline 15-9 15.6.3. Priming of dialyzer with dialysate 15-10 15.6.4. Rinsing of blood line and dialyzer 15-10 15.6.4.1. When priming function is used 15-10 15.6.4.2. When priming function is not used 15-11 15.7. Check of dialysate conductivity 15-12 15.8. Setting of UF related parameters 15-12 15.9. Connection of patient 15-13 15.10. Start of dialysis (dialysis process) 15-14 15.10.1. Start of dialysis 15-14 15.10.2. Setting of upper and lower venous pressure alarm limits 15-14 15.10.3. Setting of upper and lower arterial pressure alarm limits 15-14 15.10.4. Setting of upper and lower dialysate pressure alarm limits 15-15 15.11. Completion of dialysis (recovery process) 15-16 15.11.1. Check of UF completion 15-16 15.11.2. Start of blood recovery 15-16 15.11.3. Execution of blood recovery 15-17 15.11.4. Removal of coupler 15-17 15.11.5. Clearing away 15-18 15.11.6. Completion of blood recovery 15-18 15.12. Discontinuance of dialysis 15-19 15.12.1. Discontinuance of UF 15-19 15.12.2. Discontinuance of dialysis 15-19 CONTENTS-6

16. SINGLE NEEDLE DIALYSIS 16-1~20 16.1. Setting of dialysate related parameters 16-2 16.1.1. Setting of dialysis mode 16-2 16.1.2. Setting of dialysate concentration 16-2 16.1.2.1. Bicarbonate dialysate 16-2 16.1.2.2. Acetate dialysate 16-3 16.1.3. Setting of dialysate temperature 16-3 16.2. Connection of concentrates 16-4 16.2.1. Connection of concentrates to prepare bicarbonate dialysate 16-4 16.2.2. Connection of concentrate to prepare acetate dialysate 16-4 16.3. Setting of blood line, dialyzer and syringe 16-5 16.3.1. Setting of blood line 16-5 16.3.2. Setting of dialyzer 16-5 16.3.3. Setting of syringe 16-5 16.3.4. Setting of syringe pump 16-6 16.3.4.1. Setting of cross-section ratio of syringe 16-6 16.3.4.2. Setting of syringe operation stop time 16-7 16.3.4.3. Setting of fast-forward volume 16-7 16.4. Preparation of machine (preparation process) 16-8 16.5. Check of preparation completion of machine (preparation end process) 16-8 16.6. Priming process 16-9 16.6.1. Setting of saline vial 16-9 16.6.2. Priming of saline 16-9 16.6.3. Priming of dialyzer with dialysate 16-10 16.6.4. Rinsing of blood line and dialyzer 16-10 16.6.4.1. When priming function is used 16-10 16.6.4.2. When priming function is not used 16-11 16.7. Check of dialysate conductivity 16-12 16.8. Setting of UF related parameters 16-12 16.9. Connection of patient 16-13 16.10. Setting of single needle dialysis related parameters 16-14 16.10.1. Single needle SW ON 16-14 16.10.2. Setting of single needle changeover values 16-14 16.11. Start of dialysis (dialysis process) 16-15 16.11.1. Start of dialysis 16-15 CONTENTS-7

16.11.2. Setting of upper and lower arterial pressure alarm limits 16-15 16.11.3. Setting of upper and lower dialysate pressure alarm limits 16-16 16.12. Completion of dialysis (recovery process) 16-17 16.12.1. Check of UF completion 16-17 16.12.2. Start of blood recovery 16-17 16.12.3. Execution of blood recovery 16-18 16.12.4. Removal of coupler 16-18 16.12.5. Clearing away 16-19 16.12.6. Completion of blood recovery 16-19 16.13. Discontinuance of dialysis 16-20 16.13.1. Discontinuance of UF 16-20 16.13.2. Discontinuance of dialysis 16-20 17. SEQUENTIAL DIALYSIS 17-1~2 17.1. ON setting of sequential dialysis 17-1 17.2. OFF setting of sequential dialysis 17-1 18. CHECK AND MAINTENANCE 18-1~22 18.1. Check and maintenance by operator 18-1 18.1.1. Check and maintenance before and after operation 18-1 18.1.1.1. Test mode 18-1 18.1.2. Cleaning and disinfection of machine outside 18-2 18.1.3. Disinfection and rinsing of fluid line inside 18-2 18.1.4. Acetic acid rinsing of fluid lines 18-2 18.2. Regular check by engineer 18-3 18.2.1. Check before power ON 18-4 18.2.2. Check of leakage current 18-5 18.2.3. Check of accuracy of pressure sensor 18-6 18.2.4. Check of syringe pump 18-7 18.2.4.1. Check for fixation of pulley 18-7 18.2.4.2. Check for accuracy of syringe pump 18-7 18.2.5. Check of accuracy of UF 18-8 18.2.6. Check of accuracy of blood leak sensor 18-9 18.2.6.1. Visual check of blood leak sensor 18-9 18.2.6.2. Zero revisions of blood leak sensor 18-10 18.2.7. Check of accuracy of blood pump flow rate 18-11 18.2.7.1. When electronic balance is used 18-11 18.2.7.2. When measuring cylinder is used 18-11 CONTENTS-8

18.2.8. Check of accuracy of bubble sensor 18-12 18.2.8.1. Preferable method 18-12 18.2.8.2. Simple method 18-12 18.2.9. Check of accuracy of temperature sensor 18-13 18.2.10. Check of accuracy of conductivity cell 18-14 18.2.11. Replacement of components of GVS filter (Supply water line) 18-15 18.2.12. Replacement of components of electromagnetic valve 18-16 18.2.13. Replacement of component of pump 18-18 18.2.13.1. Overall views of pump 18-18 18.2.13.2. Contents parts list 18-18 18.2.13.3. Replace method 18-20 18.3. Maintenance by qualified engineer 18-22 19. STORAGE 19-1~2 19.1. Actions before storing machine 19-1 19.1.1. Cleaning of enclosure 19-1 19.1.2. Priming of formalin solution 19-1 19.2. Environmental conditions required to store machine 19-2 19.3. Check and test before re-operation of machine 19-2 20. MACHINE MOVING AND CAUTIONS 20-1~2 21. SPECIFICATIONS 21-1~12 21.1. Specifications for machine 21-1 21.1.1. Dimension and weight 21-1 21.1.2. Power source 21-1 21.1.3. Electric safety 21-1 21.1.4. Environment 21-2 21.2. Performance of machine 21-3 21.2.1. Dialysate flow rate 21-3 21.2.2. Deaeration 21-3 21.2.3. UFR control 21-3 21.2.4. Temperature control 21-3 21.2.5. Conductivity control (BICARBONATE 21-4 21.2.6. Conductivity control (ACETATE) 21-4 21.2.7. Disinfection control 21-5 CONTENTS-9

21.2.8. Acid rinse control 21-5 21.2.9. Water rinse control 21-5 21.2.10. Blood pump 21-6 21.2.11. Syringe pump 21-6 21.3. Safety monitors 21-7 21.3.1. Venous pressure monitor 21-7 21.3.2. Dialysate pressure monitor 21-7 21.3.3. Bubble detector 21-7 21.3.4. Blood leak detector 21-8 21.3.5. Temperature monitor 21-8 21.3.6. Conductivity monitor 21-8 21.4. Specifications for options 21-9 21.4.1. Arterial pressure sensor 21-9 21.4.2. Backup unit of blood pump for power failure 21-9 21.4.2.1. Machine specification 21-9 21.4.2.2. Energy cell specification 21-9 21.4.3. Heat exchanger 21-10 21.4.4. Acid rinse port unit 21-10 21.4.5. Hot rinse Assy 21-10 21.4.5.1. Hot chemical disinfectant rinse control 21-10 21.4.5.2. Hot water rinse 21-11 21.4.6. Large single lump assy 21-11 21.5. Special note 21-11 21.5.1. Language 21-11 22. DATA FOR USE 22-1~8 22.1. Blood tubing set applicable to SURDIAL 22-1 22.1.1. A065(A067) / V643 22-1 22.1.2. A064(A066) / V643 22-2 22.2. Layouts of blood tubing 22-4 22.2.1. Model A065(A067) / V643 22-4 22.2.2. Model A064(A066) / V643 22-5 22.3. Flow chart and components of SURDIAL 22-6 22.3.1. Flow chart 22-6 22.3.2. Component of SURDIAL 22-7 CONTENTS-10

CAUTIONS FOR SAFETY To use the machine (SURDIAL) safely, it shall be operated in accordance with specified procedures and shall be maintained regularly after reading and full understanding cautions included in this Operation Manual. Procedures for operation and cautions for safety contained in the manual are only applicable to the case when the machine is used for specified purpose. It shall be noted that any danger caused by use of the machine based on any procedures not specified in the manual shall be responsible for user. (1) Messages with symbol for safety are classified into the following three categories: DANGER Cases critically causing death or severe injury of user by misuse of the machine WARNING Cases potentially causing death or severe injury of user by misuse of the machine CAUTION Cases potentially causing injury of user and/or loss of property by misuse of the machine (2) NOTE Reference to operation of the machine Design of the machine may be changed partially based on improvement of it at any progressive step and the partially improved design may be different from that contained in the manual. If you have any question, please contact our branch or agency near your place without hesitation. CAUTION-1

DANGER Before use of the machine, read and full understand this Operation Manual. The machine can be used safely and reliably when operated and maintained as specified in the manual. Before operating the machine, read and full understand the manual to avoid human injury and the machine damage. Be familiar with procedure how to stop the machine without delay. Be familiar with procedure how to stop the machine without delay in emergency to avoid serious problem occurrence. The machine shall be operated by well trained and qualified person only unless otherwise instructed formally. Be familiar with procedure how to correct the machine when it is stopped accidentally. Correct the machine as prescribed in the manual after checking the stopped machine conditions. DO NOT touch any board, wiring and terminal with hand in all the cases other than maintenance mode. DO NOT touch any non-insulated wiring and terminal. DO NOT touch any board with wet hand. Disconnect plug from receptacle when any terminal bed is manipulated. Take care of the following when patient is connected to the machine or disconnect from it. DO NOT allow air ingress into patient body. DO NOT connect blood line to patient before starting priming operation. DO NOT connect blood line to patient during rinsing operation. Take care for patient not to be contaminated with harmful virus or chemical. DO NOT connect bloodline to patient during releasing any alarm function. It may critically causing death or severe injury of patient in this case. Check frequently whether blood line is connected correctly to avoid danger to patient due to blood leak caused by disconnection of the line when incorrectly connected, and due to rupture of the line caused by excess pressure application. CAUTION-2

WARNING DO NOT use any electric wave generating electronic devices in room or building where the machine is operated. DO NOT use electric wave generating electronic devices such as portable telephone, transceiver and radio controlled toy in hospital to avoid malfunction of the machine. Manage and instruct for the devices not to be brought in and not to be used in hospital to prevent trouble occurrence. DO NOT change parameter setting during dialysis excluding the case of emergency. Change parameter setting before connecting the machine to patient. Set parameter as intended after full understanding its function. Provide drain port at floor. Keep power cord away from floor to avoid electric shock if short-circuit is caused by water leak. Provide drain port at floor near the machine. Read the manual before starting check and maintenance of the machine. Read and full understand the manual before starting check and maintenance. Check and maintain the machine as prescribed in the manual. Entrust check and maintenance not prescribed in the manual to authorized specialist. DO NOT touch any SW unnecessary for the machine operation during dialysis. DO NOT place the machine at an angle of 5 against vertical line under loading any object on any container support or hunger to prevent falling down of the machine. DO NOT load any object on any container support or hunger during transport of the machine. DO NOT place the machine at an angle of 10 against vertical line under unloaded condition to prevent falling down of the machine. DO NOT connect any devices other than approved ones to the machine. Otherwise, the total leakage current may exceed the acceptable limit. CAUTION-3

Injury or death of patient may be caused if the machine is operated, maintained or calibrated based on any procedure not specified in this operation manual or if any accessory device not approved by us is used. In such case, the injury or death is out of our control. The machine shall be operated, maintained or calibrated by well trained and qualified specialist based on the procedure specified in this operation manual. Check actual dialysate concentration by meter. Check whether dialysate concentration is correct by the test using osmometer, conductivity meter or flame photometer. Check whether dialysate concentration is correctly displayed. Check no residual disinfectant and acid after rinsing completion. After disinfection using sodium hypochlorite or peracetic acid; or after acid rinsing, check whether residue of the disinfectant or acid is contained in fluid supply and drain lines by the test using test paper or reagent. DO NOT apply hot rinse without hot rinse option. It might cause breakdown of the machine. CAUTION-4

CAUTION Before starting the machine installation, read and full understand the instructions specified in 6. INSTALLATION" of this Operation Manual. The machine shall be installed by well trained and qualified person only. Before connecting any optional device to the machine, read and full understand Handling Manual of the device. The connection shall be performed by well trained and qualified person only. DO NOT give shock or impact to display and operation panel. Take care not to give shock or impact to display and operation panel during cleaning. Clean the machine thoroughly before use of it. If the machine is used after long term of storage, rinse using water for one hour or longer. If the machine is used after long term of storage without removing water, rinse well until dirty water is not drained. Take care for the machine to be kept clean. If the machine is contaminated with blood, dialysate or rinsing fluid, remove it by wiping without delay. Perform regular cleaning and disinfection. There are the cases that display and process do not respond to operation of some SW s under certain conditions. DO NOT operate the SW s forcibly. Use the color coded dialysate concentrate container. Non- color coded one is not applicable to the machine. Take care to avoid infection during handling of disposables because there is possibility of contact with hepatitis virus and/or contaminated drug or chemical. Use water, dialysate concentrates and substitute of acceptable qualities for safe and effective operation of the machine. Gap between rollers and housing of blood pump can be adjusted within allowable range. The adjustment may be required according to size of rolling tube. CAUTION-5

Chapter 1 APPLICATION (a) Single patient dialysis machine, SURDIAL is applied to treatment of patients with acute or chronic renal failure by dialysis when the application is instructed by doctor. (b) SURDIAL can be used at both hospital and home. 1-1

Chapter 2 CONTRAINDICATION Any application other than dialysis is contraindicated. 2-1

Chapter 3 CAUTIONS Take care of the followings in use of the machine: 1. The machine shall be operated by well trained technician only. 2. Cautions for installation (1) Install the machine at place without fear of contact with water. (2) Install the machine at place without fear of adverse effects caused by abnormal atmospheric pressure, temperature and/or humidity; insufficient ventilation, direct exposure to sunlight; and dust, salt and/or sulfur containing air. (3) Handle the machine under avoiding slant placement, vibration and shock during installation and transportation. (4) DO NOT install the machine at chemical storing or gas generating place. (5) Frequency, voltage and amperage (power consumption) of power supply should be as specified. (6) Connect the machine with earth correctly. 3. Cautions prior to starting operation (1) Check SW contacts, polarity, dial settings, meters and the like to assure correct operation of the machine. (2) Check correct connection of the machine with earth. (3) Check correct connections of all wires. (4) Take care that operation of the machine combined with other device may cause adverse effects. (5) Recheck integrity of lines connected to patient directly. 3-1

4. Cautions during operation (1) Monitor always whether the machine and patient are maintained normally. (2) If trouble of the machine or patient is detected, take appropriate actions such as the machine stop so that the patient is kept safe. (3) Take care that there is no direct contact of the machine to patient. 5. Cautions after operation (1) Turn off power after returning operation SW s, dials and the like to original positions based on prescribed procedures. (2) DO NOT forcibly pull any cord and the like to disconnect.. (3) Take care the followings to store or transport the machine: 1) Store the machine at place without fear of contact with water. 2) Store the machine at place without fear of adverse effects caused by abnormal atmospheric pressure, temperature and/or humidity; insufficient ventilation, direct exposure to sunlight; and dust, salt and/or sulfur containing air. 3) Handle the machine under avoiding slant placement, vibration and shock during storage and transportation. 4) DO NOT store the machine at chemical storing or gas generating place. (4) Clean accessories, cords, and the like in order and clean them to store. (5) Store the machine after cleaning it for the next use without any trouble. 6. If the machine is damaged, indicate the damaged conditions to request repair by specialist. 7. DO NOT remodel or modify the machine. 8. Check and maintenance (1) Perform regular check and maintenance of the machine and its components. (2) When the machine is used after storage for some time, check and maintain so that it can be operated normally and safely. 9. Read and understand other CAUTIONS contained in the operation manual. 3-2

Chapter 4 DEFINITION Terms contained in this Operation Manual shall be defined as follows: Acetate means salt required to prepare acetate dialysate which is used for acetate dialysis. Acid rinsing means process to rinse dialysate line by passing dilute acetic acid through it. "Arterial pressure (option)" means pressure in arterial drip chamber determined by pressure sensor connected with the chamber through detection line. Back siphon means back flow of waste dialysate toward the machine due to pressure in dialysate drain line is higher than that in the machine, can be caused by any reason when machine is stopped. "Bicarbonate" means salt required to prepare bicarbonate dialysate which is used for bicarbonate dialysis. Blood leak detector means device used to detect blood leak to dialysate optically. Blood line means the circuit used to circulate extracorporeal blood through dialyzer. Blood pump means pump used to circulate blood through dialyzer and blood line. Roller type pump is used in SURDIAL. Bubble detector means device used to detect air bubble in blood passing through venous line. Bypass means process to drain dialysate through bypass line without passing dialysate through dialyzer. Clamp means device used to close blood line by clamping when air bubble is detected in venous line. "Concentration" means Na+ concentration in dialysate derived from measurement of dialysate conductivity. Conductivity sensor means the sensor used to measure conductivity of dialysate. "Dialysate" means solution dissolving various salt used to remove metabolic waste and excess fluid from blood through dialyzer membrane. Dialysate concentrate connection ports means those provided with male connectors each used to connect with each of acetate or A and B concentrates. "Dialysate pressure: DP" means pressure at dialyzer inlet determined by referring to pressure measured at dialysate line by pressure sensor. "Dialysis" means process to remove metabolic waste and excessive fluid from a circulating extracorporeal blood by diffusion. Dialyzer means device containing membrane through which metabolic waste and 4-1

excess fluid are removed. DIALYSIS screen : PREPARATION COMPLETION, DIALYSIS and RECOVERY are enabled by the mode. Disinfection means process to disinfect dialysate line by passing disinfectant such as dilute sodium hypochlorite or peracetic acid solution through it. Disinfectant concentrate connection port means that provided with male connector used to connect with disinfectant. "Double needle dialysis" means dialysis performed by puncturing artery and vein using respective needles to circulate blood. Earth means ground connection. PREPARATION screen : message to operator is displayed during preparation process. Priming means process to prime dialyzer with saline or the like. RINSING (AUTOMATIC RINSING 1) screen : pattern of the disinfection and current time are displayed. RINSING (AUTOMATIC RINSING 2) screen : pattern of the disinfection and current time are displayed. Rinsing program means program to allow automatic implementation of water rinsing, disinfection, acid rinsing and the like in accordance with previously set sequence and pattern. RINSING WAITING screen : list of rinsing patterns is displayed and desired rinsing mode is selected by the mode. RINSING (WATER RINSING) screen : the mode is displayed. "Sequential dialysis" means execution of ultrafiltration only without passing dialysate through dialyzer. "Single pump-single needle dialysis" means dialysis performed by puncturing arteriovenous fistula using single needle under operating of single pump. Syringe pump means pump designed to load syringe containing heparin which is infused to blood line at a preset infusion rate through heparin line communicated with the syringe. Temperature sensor means the sensors used to measure temperature of supply water at 2 locations and dialysate at 1 locations. "Transmembrane pressure: TMP" means [venous pressure] - [DP]. TMP is for reference only. TMP off-set means pressure difference between Venous pressure sensor and dialysate pressure sensor caused by the setting height difference between both pressure sensor and other environmental factor. This machine calculate TMP off-set value as the average pressure difference value (TMP off set = dialysate pressure Venus pressure) during 1 round of before first ultra filtration process of beginning of dialysis, and after 1 hour of dialysis treatment started. "Ultrafiltration" means process to remove fluid from a circulating extracorporeal blood through dialyzer membrane. "Venous pressure" means pressure in venous drip chamber determined by pressure sensor connected with the chamber through detection line. Viscous control system means system used to prepare dialysate and to control UF. The principle are next section. 4-2

Viscous pump means bellowphragm pump receiving viscous silicone used to control ultrafiltration (UF) and to prepare dialysate. Water rinsing means process to rinse dialysate line by passing water through it. 4-3

The principle of VCS (Viscous Control System) Dialysate mixing As shown in the below Fig., water is supplied to the right side of the viscous chamber. By upward movement of piston of the viscous pump during temporally stop of the water supply, A concentrate (for bicarbonate dialysis) of a volume corresponding to the piston stroke is aspirated in the right side. By changing the piston stroke, dialysate concentration can be changed. During the supply and aspiration, used dialysate is drained from the left side. UF control As shown in the below Fig., fresh dialysate prepared in the right side is transferred to the left side through dialyzer by operating the pump. By upward movement of piston of the viscous pump, capacity of closed circuit (shown as bold lines) is increased, generating negative pressure in dialysate compartment of the dialyzer. As the result, fluid of a volume corresponding to the piston movement is removed from blood. By changing the piston stroke, it is possible to change UF. The system is build up so that dialysate preparation and UF control cycle is alternating, which means that two sets are provided in the system. US and JAPAN PATENTS 4-4

5. SPECIFICATIONS Specification Allowable set range -400~+400mmHg No Required condition Allowable indication range Accuracy of indicated value Digital indication -400 to +400mmHg Indicator indication - -400 ~ +400mmHg Actual pressure±10mmhg or ±10% (F.S.) whichever greater No Excluding indicator 5-1

Chapter 6 INSTALLATION Environmental condition and methods of unpacking, assembling, connection and wiring required to install the machine and methods of disposal of used machine and packaging materials are specified below. These operations should be performed by trained and qualified person(s) only. 6.1. Installation environment The following requirements should be fulfilled to assure safe and effective use of the machine. 6.1.1. Ambient conditions During : Use Daily storage Storage for one month Transport or more; and Transport without fluid with contained fluid Temp. ( C) 15 to 35 10 to 40 5 to 50-10 to 50 Relative humidity (%) Atmospheric pressure (hpa) 35 to 80 15 to 85 15 to 85 15 to 85 795 to 1062 No condensing 795 to 1062 795 to 1062 700 to 1062 NOTE Avoid direct exposure of the machine to sunlight 6.1.2. Power supply 6.1.2.1. When machine power rating is AC 230V The machine is designed to be operated by power supply of AC 230V ± 10%, 50 Hz. Receptacle conforming to protective earth type plug of AC rating of 230V, 10 A is required to connect with the machine. Connect the plug with the receptacle correctly. 6.1.2.2. When machine power rating is AC 110V The machine is designed to be operated by power supply of AC 110V ± 10%, 50 Hz. Receptacle conforming to protective earth type plug of AC rating of 110V, 20 A is required to connect with the machine. Connect the plug with the receptacle correctly. 6-1

WARNING DO NOT use AC power plug or adapter disconnecting safety earth. DO NOT connect the machine plug to receptacle through adapter. If power installation is suspected to have any problem, request check of wiring by electric engineer. 6.1.3. Necessary space requirements to use the machine Space above the top of the machine should be 5 cm, that at each of right and left sides should be 10 cm and that at rear side should be 20 cm. A ventilation port with a diameter 20 cm should be provided or any side other than bottom should be cleared so that the side is completely exposed to atmosphere. 6.1.4. Water supply and drainage conditions Water supply and drainage conditions should be checked for normal operation of the machine. 6.1.4.1. Water supply pressure Pressure : 0.049 to 0.74 MPa (0.5 to 7.5 kgf/cm 2 ) 6.1.4.2. Water supply flow rate Flow rate : 750 ml/min 6.1.4.3. Water supply temperature Temperature : 17 to 30 C. The temperature should be lower than the set dialysate temperature by 5 C. If heat exchanger is used, the temperature should be 5-30 C which should be lower than the set dialysate temperature by 5 C. 6.1.4.4. Water quality Supply water must be filtered through a 25 µm filter and the quality must be soft. The quality must be monitored by regular analysis to maintain the acceptable quality. WARNING Use water of quality meeting AAMI - approved American National Standard for Haemodialysis System, RD5, 1981, Section 3.2. Otherwise, patient may suffer from seriously adverse effects. 6-2

6.1.4.5. Concentrate line pressure Pressure : Min : -100 mmhg (136 cm below inlet) Max : +100 mmhg (136 cm above inlet) 6.1.4.6. Drainage Drain flow rate : 1500 ml/min Drain tube tip must be placed above the machine floor by 0 to 60cm and it should not be contacted with waste fluid level in drain groove. 6-3

6.2. Unpacking and check of contents WARNING Unpacking should be performed by at least 2 operators. Otherwise bone fracture may be caused by drop of the machine on body. NOTE Tightening components such as screws and nuts are mm size. If missed, use those of the same mm size. (1) Just after unpacking, check conformance of manufacturing No. indicated on the package to that on the machine. (2) Check whether the following accessories are provided and whether the machine and accessories are not damaged. (a) Hanger ( 1) (b) Main lamp ( 1) (c) Tray ( 1) (e) IV pole ( 1) +O-ring ( 2) (d) Main lamp cap ( 1) Fig. 6-1 Accessories 6-4

(f) Blood pump handle ( 1) (g) Coupler set ( 1) (h) Disinfectant concentrate container connection set ( 1) (i) Dialysate concentrate container connection set (One for each of A and B) (j) Dialyzer holder ( 1) (k) Tube holder ( 2) (L) CL filter ( 1) Fig.6-1 Accessories 6-5

6.3. Procedure for assembling 6.3.1. Cautions Take care of the followings at assembling. (a) Place the machine on horizontal and stable floor. (b) Sufficient space to assemble should be provided. (c) Use accessories packaged with the machine and/or designated option to assemble. 6.3.2. Attachment of I.V. pole, hanger and main lamp Fig. 6-2 Attachment of I.V. pole Attach the pole to the machine as shown in Fig. 6-2. Harness can be easily passed through the pole by binding strand to the machine side connector followed by passing the connector bound strand through the pole. Engage the connector with the lamp side connector securely. Wires of the both connectors are colored as shown in the below Table: Machine side (Letters on tube) Lamp side Black or white (LAMP) Black or white Red Red 6-6

6.3.3. Connector for each concentrate container Drill concentrate container cap to prepare hole as shown in the below Fig. 6-3. Then cut off suction port by a depth suitable for the container to make notch as shown in the below Fig. 6-4. Concentrate container cap (Prepare hole of φ18.5mm) For disinfectant concentrate container For A or B concentrate container Fig. 6-3 Connectors for concentrate containers Cut off Suction port Fig. 6-4 Preparation of suction port NOTE If the container is provided with 2 ports closed with respective caps, engage the connector with one of the ports and loosen the cap of the other port to allow air introduction. If the container is provided with only one port closed by one cap, engage the connector with the port and loosen the cap to allow air introduction. The caps (L and S) are not provided with the machine. Use L or S cap of the containers. Prepare 3 or 4 connectors for containers receiving A, B and disinfectant concentrates; and for container receiving acetic acid concentrate as option. 6-7

6.4. Procedures for tube and plug connections 6.4.1. Connections of fluid supply and drain lines, coupler and power plug CAUTION Before and after tube and plug connection, check whether installation environment conforms to the requirements specified in 6.1.1 of this operation manual. Connect dialysate coupler tubes to ports To dialyzer and From dialyzer securely by full advancing the tubes followed by banding them. 6.4.1.1. Connection of dialysate coupler tubes (1) Connect tube at blue band side of coupler to dialysate port To dialyzer securely by full advancing the tube followed by banding. (2) Connect tube at red band side of coupler to dialysate port From dialyzer securely by full advancing the tube followed by banding. (3) Cut red band any position. Connect CL filter to cutting point followed by banding. Connect the side of inject port for CL filter to the edge From dialyzer. 6.4.1.2. Connections of drain port of machine side Use tube of an internal diameter of 8 mm and a length of 2 m or shorter to connect to the port. Fix the connection securely by strapping with metal clip. CAUTION By change of height of the tube free end from drain port placed at floor, dialysate conductivity may be changed due to change of drain pressure. If the height is changed, check the conductivity. 6.4.1.3. Connection of water supply port Use pressure resistant tube of an internal diameter of 8 mm. Fix the connection securely by strapping with metal clip. 6.4.1.4. Connection of power plug Insert power plug of the machine in receptacle securely by full advancing the plug. 6-8

6.4.2. Connection of each concentrate 6.4.2.1. Connection to execute dialysis operation (before blood line connection) (1) Load container of A concentrate (or acetate concentrate) and that of B concentrate on respective container supports. (2) Connect connectors of the machine for A and B concentrates to respective connectors of the containers. (3) Check whether connector of the machine for disinfectant concentrate is connected to rinse port correctly. (4) If acid rinse option is used, check whether connector for acetic acid concentrate is connected to rinse port correctly. CAUTION Connect each concentrate connector, rinse port and the like securely. Otherwise, trouble such as water leak or air aspiration may be caused. During acetate dialysis (B concentrate is not used), connect connector for B concentrate to corresponding rinse port placed at upper part of the machine. 6.4.2.2. Connection for water rinsing (1) Check whether all connectors are connected to rinse ports. CAUTION Connect each concentrate connector, rinse port and the like securely. Otherwise, trouble such as water leak or air aspiration may be caused. Connect all 3 connectors of the machine for A, B and disinfectant concentrates to respective rinse ports. If acid rinse option is used, connect acetic acid concentrate connector to corresponding rinse port. 6.4.2.3. Connection for disinfection (1) Connect connector placed at rear side of the machine for disinfectant concentrate to container for disinfectant concentrate. (2) Check whether connectors of the machine for A and B concentrates are connected to respective rinse ports securely. (3) If acid rinse option is used, check whether connector for acetic acid concentrate is connected to rinse port correctly. CAUTION Connect each concentrate connector, rinse port and the like securely. Otherwise, trouble such as water leak or air aspiration may be caused. 6-9

6.4.2.4. Connection for acetic acid rinsing (when acid rinse option is not used) (1) Connect connector placed at rear side of the machine for disinfectant concentrate to container for acetic acid concentrate. (2) Check whether connectors of the machine for A and B concentrates are connected to respective rinse ports securely. CAUTION Connect each concentrate connector and the like securely. Otherwise, trouble such as water leak or air aspiration may be caused. 6.4.2.5. Connection for acetic acid rinsing (when acid rinse option is used) (1) Connect connector placed at rear side of the machine for acetic acid concentrate to container for the concentrate. (2) Check whether 3 connectors for A, B and disinfectant concentrates are connected to respective rinse ports securely. CAUTION Connect each concentrate connector and the like securely. Otherwise, trouble such as fluid leak or air aspiration may be caused. 6.4.2.6. Connection for automatic rinsing (1 or 2) (when acid rinse option is used) (1) Connect connector placed at rear side of the machine for disinfectant concentrate to container for the concentrate. (2) Connect connector placed at rear side of the machine for acetic acid concentrate to container for the concentrate. (3) Check whether connectors of the machine for A and B concentrates are connected to respective rinse ports securely. CAUTION Connect each concentrate connector, rinse port and the like securely. Otherwise, trouble such as water leak or air aspiration may be caused. Use disinfectant and acetic acid concentrates of specified concentrations. 6-10

6.4.3. Air purge The machine is shipped after filling fluid line with air. To install the machine, remove air in accordance with the procedures shown in message screen of display. The air is removed automatically within 7 to 10 minutes. CAUTION Before starting air purge, check whether water supply is enabled. If disabled, pump may be damaged due to unloaded operation. NOTE When the machine is turned on after long term, date and time may be initialized and E50 RAM INITIALIZE error may be occurred to initialize SETTING 1 screen. Because RAM back up battery is emptied. The check and re-input should be performed by well trained person. RAM back up battery is rechargeable. It is full charged by power on the machine about 22 hours continuously. It is emptied by turn off the machine about 7-10 days. (1) Check whether all connectors are connected to respective rinse ports correctly. (2) Check whether water can be supplied. (3) The air purge process is enabled during rinse wait mode only. Select the mode. (4) Press [F 5] SW to display maintenance mode menu. (5) Press [F 3] or [F 4] SW to select "MODE9 followed by pressing [F 1] SW. (6) After checking display of [MAINTE 9], press [F 1] SW to start the air purge process. (7) To terminate the process forcibly during its execution, press [F 1] SW. (8) Upon completion of the process, it is shown in the message screen. 6-11

6.5. Disinfection of the dialysate circuit Be sure to disinfect the dialysate circuit before use of the machine. 6.6. Disposal of used machine Procedures how to dispose materials of the machine are described below: (a) Resin such as electrical circuit board and silicone oil; rubber and electric wire should be disposed as industrial waste. If the disposal is covered by regional regulation, dispose them based on it. (b) To distinguish iron from stainless steel, use magnet because the iron is attracted by it, while the stainless steel is not so. The iron is surface finished by painting or plating to prevent rust formation. 6.7. Disposal of used packaging materials Dispose used packaging materials after separating to groups of wood, styrol foam, corrugated board and the like. 6.8. Disposal of blood lines and dialyzer Dispose used blood lines and dialyzer by suitable manners specified by hospital or medical facilities to prevent risk of infection. 6-12

Chapter 7 MAIN FUNCTIONS AND COMPONENTS Main functions and components of the machine are as follows: (1) Preparation of bicarbonate dialysate (2) Preparation of acetate dialysate (3) Ultrafiltration control by viscous control system (VCS) (4) Sequential dialysis (5) One clamp single needle dialysis (6) Rinsing program (7) Blood pump (three roller type) (8) Bubble detector (9) Clamp (10) Auto self check (11) Blood leak detector (12) Auto gas purge (13) Message screens of display (14) Auto priming (15) Drain from dialyzer (16) Check of leak from closed circuit (17) Main lamp (18) Double syringe pump (19) Arterial pressure sensor (option) (20) Backup for blood pump at power failure (option) (21) Heat exchanger (option) (22) Acid rinse port (option) (23) Hot rinse-programming (option) 7-1

Chapter 8 CONSTRUCTION OF MACHINE 8.1 Overall construction 8.1.1 Overall views l Main Operation l Blood line setting l Front view Right side Fig. 8-1-1 Front and right side views of SURDIAL 8-1

Power supply Rear side view Left side view Fig. 8-1-2 Rear and left side views of SURDIAL 8-2

8.1.2 Components of machine and their purposes and functions No. Component Purpose and function 1 Sampling port Port used to take dialysate sample 2 Rinse port for A concentrate 3 Connector for A concentrate Port used to connect to connector of A concentrate container during rinsing operation Connector used to connect connector of bicarbonate A concentrate container 4 Rinse port for B concentrate 5 Connector for B concentrate Port used to connect connector of B concentrate container during rinsing operation Connector used to connect connector of bicarbonate B concentrate container 6 Flow meter Meter use to indicate flow rate of dialysate supplied to dialyzer 7 Dialysate return tube Tube used to return used dialysate to port From Dialyzer 8 Dialysate supply tube Tube used to supply fresh dialysate to port To Dialyzer 9 Dialysate return coupler Coupler used to connect used dialysate return tube to dialyzer 10 Dialysate supply coupler Coupler used to connect fresh dialysate supply tube to dialyzer 11 Bypass connector Connector used to bypass ports From Dialyzer and To Dialyzer when couplers Nos. 9 and 10 are set to the machine during rinsing operation 12 Limit SW for bypass connector SW used to detect whether coupler is received in coupler holder 13 Coupler holder Holder used to receive coupler during rinsing operation 14 Dialysate flow rate Valve used to regulate dialysate flow rate in closed regulating needle valve circuit 15 Container support Support used to load dialysate concentrate container 16 Port From Dialyzer Port used to return used dialysate from dialyzer 17 Port To Dialyzer Port used to supply fresh dialysate to dialyzer 8-3