Nipro Surdial User manual

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 Life time Single Patient Dialysis Machine, SURDIAL 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.

11-1 11.1.2.Cleaning and

disinfection of dialysate concentrate connectors and rinse ports ※ Delete cleaning procedure using alcohol.

21-3 21.2.1.Dialysate flow

Remove blood and/or organic substances from the machine enclosure using soft cloth wetted with tepid water or w ater. DO NOT use organic solvents such as thinner and benzene to prevent patient damage.

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.

UFR is≦2.70L/h when dialysate flow rate is 300mL/min.

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.

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.

UFR is≦4.00L/h when dialysate flow rate is 30L/min.

0R1A01-0105

PREFACE

CONTENTS

CAUTIONS FOR SAFETY

1. INTENDED USE

2. CONTRAINDICATION

3. CAUTIONS

4. DEFINITIONS

5. SYMBOL FOR SAFETY

･･････････････････････････････････････････････････････････････････

･･････････････････････････････････････････････････････････････････････

････････････････････････････････････････････････････････････････････

6. INSTALLATION

6.1. Installation environment

6.1.1. Ambient conditions

6.1.2. Power supply

6.1.2.1. When machine power rating is AC 230V

6.1.2.2. When machine power rating is AC 100V

6.1.3. Necessary space requirements to use the machine

6.1.4. Water supply and drainage conditions

6.1.4.1. Water supply pressure

6.1.4.2. Water supply flow rate

6.1.4.3. Water supply temperature

6.1.4.4. Water quality

6.1.4.5. Concentrate line pressure

6.1.4.6. Drainage

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･････････････････････････････････････････････････････････････

･･･････････････････････････････････････････････････････････

･････････････････････････････････････････････････････････

･･････････････････････････････････････････････････････････

･･･････････････････････････････････････････････････････････････

････････････････････････････････････････････････････････････････････････

･･････････････････････････････

････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････

････････････････････････････････････････････････

････････････････････････････････････････････････････････････

････････････････････････････････････････････････

･･･････････････････････････････････････････････････････････････

CAUTION-1~6

1-1~2

2-1~2

3-1~2

4-1~4

5-1~2

6-1~12

6-1 6-1 6-1 6-1 6-1 6-2 6-2 6-2 6-2 6-2 6-2 6-3 6-3

6.2. Unpacking and check of contents

6.3. Procedure for assembling

6.3.1. Cautions

6.3.2. Attachment of I.V. pole, hanger and main lamp

6.3.3. Connector for each concentrate container

6.4. Procedures for tube and plug connections

6.4.1. Connections of fluid supply and drain lines, coupler and power plug

6.4.1.1. Connection of dialysate coupler tubes

6.4.1.2. Connections of drain port of machine side

6.4.1.3. Connection of water supply port

6.4.1.4. Connection of power plug

･･･････････････････････････････････････････････････････････････････

････････････････････････････････････････････････････････

･････････････････････････････････････････････････

･･････････････････････････････････

･･････････････････････････････････････

･･････････････････････････････････････････

･･････････････････････････････････････

･･････････････････････････････････

･･･････････････････････････････････････････

･････････････････････････････････････････････････

････････････････

CONTENTS-1

6-4 6-6

6-6 6-6 6-7

6-8 6-8 6-8 6-8 6-8 6-8

6.4.2. Connection of each concentrate

6.4.2.1. Connection to execute dialysis operation(before blood line connection)

6.4.2.2. Connection for water rinsing

6.4.2.3. Connection for disinfection

6.4.2.4. Connection for acetic acid rinsing (when acid rinse option is not used)

6.4.2.5. Connection for acetic acid rinsing (when acid rinse option is used)

6.4.2.6. Connection for automatic rinsing (1 or 2)(when acid rinse option is used)

6.4.3. Air purge

･･････････････････････････････････････････････････････････････････

･･･････････････････････････････････････････････

･･････････････････････････････････････････････

････････････････････････････････････････････････

･････････

････････････

･･･････

6-9 6-9 6-9

6-9 6-10 6-10 6-10 6-11

6.5. Disinfection of the dialysate circuit

6.6. Disposal of used machine

6.7. Disposal of used packaging materials

6.8. Disposal of blood lines and dialyzer

7. MAIN FUNCTIONS AND COMPONENTS

8. CONSTRUCTION OF MACHINE

8.1. Overall construction

8.1.1. Overall views

8.1.2. Components of machine and their purposes and functions

8.2. Operation panel

8.2.1. Construction of operation panel

8.2.2. Components of operation panel and their purposes and functions

･･･････････････････････････････････････････････････････････････

････････････････････････････････････････････････････････････････

･･･････････････････････････････････････････････････････

･･･････････････････････････････････････････････････

･････････････････････････････････････････････････････････････

･･･････････････････････････････････････････････

････････････････････････････････････････････

･･････････････････････････････････････････････

････････････････････････････････････････････

8-1~14

････････････････････････

･･･････････････････････････････････････････････

･･････････････････

6-12 6-12 6-12 6-12

7-1~2

8-1

8-3

8-5

8-6

8.3. Blood line setting panel

8.3.1. Construction of blood line setting panel

8.3.2. Components of blood line setting panel and their purposes and functions

8.4. Power box

8.4.1. Construction of power box

8.4.2. Components of power box and their purposes and functions

8.5. Main lamp assembly

8.5.1. Construction of main lamp assembly

8.5.2. Components of main lamp assembly and their purposes and functions

CONTENTS-2

･･････････････････････････････････････････････････････････

･････････････････････････････････････････

･･････････

････････････････････････････････････････････････････････････････････

･･･････････････････････････････････････････････････

･････････････････････

･･･････････････････････････････････････････････････････････

･･････････････････････････････････････････

････････････

8-9

8-9 8-10

8-11 8-11 8-12

8-13 8-13 8-14

9. DISPLAY

･･･････････････････････････････････････････････････････････････････････

9-1~18

9.1. Layout of display

9.2. Wake up screen

9.3. Rinse screen

9.3.1. Rinse menu

9.3.2. Rinse wait

9.3.2.1. RINSE1: WATER

9.3.2.2. RINSE2:CHEMICAL

9.3.2.3. RNSE3:AUTO1 C&D

9.3.2.4. RINSE4: AUTO2 C&D

9.3.3. Rinse execution

9.3.3.1. RINSE1: WATER

9.3.3.2. RINSE2: CHEMICAL

9.3.3.3. RINSE3: AUTO1 C&D

9.3.3.4. RINSE4: AUTO2 C&D

9.3.4. Rinse end

9.3.4.1. RINSE1: WATER

9.3.4.2. RINSE2:CHEMICAL

9.3.4.3. RINSE3:AUTO1 C&D

9.3.4.4. RINSE4:AUTO2 C&D

･･･････････････････････････････････････････････････････････････

････････････････････････････････････････････････････････････････

･･･････････････････････････････････････････････････････････････････

････････････････････････････････････････････････････････････････

･･････････････････････････････････････････････････････････････････

･････････････････････････････････････････････････････････････････

････････････････････････････････････････････････････････

･･････････････････････････････････････････････････････････････････････････････････････････････････････････

･･･････････････････････････････････････････････････

･････････････････････････････････････････････････････････････

････････････････････････････････････････････････････････

･････････････････････････････････････････････････････

･･････････････････････････････････････････････････････････････････････････････････････････････････････

･･･････････････････････････････････････････････････････

････････････････････････････････････････････････････

･･････････････････････････････････････････････････････････････････････････････････････････････････････

9-3

9-5

9-6

9-7

9-8

9-9

9-9 9-10 9-10 9-10 9-10 9-10

9.4. Dialysis screen

9.4.1. Dialysis

9.4.2. Priming

9.4.3. Test mode

9.5. SettingⅠ screen

9.6. SettingⅡ screen

9.7. Maintenance menu screen

9.8. Alarm screen

10. ALARM FUNCTIONS AND

10.1. Description of alarms

10.1.1. Functions when error is alerted

10.1.2. Procedure for resetting

10.1.3. Actions to respond to alarm (flow)

10.2. Table of alarms

10.2.1. Meanings of terms contained in “Table of alarms”

10.2.2. Table of alarms

･･････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････

････････････････････････････････････････････････････････････････

････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････

･･････････････････････････････････････････････････････････････････

･･･････････････････････････････････････････････････････････････

･･････････････････････････････････････････････････････

RESETTING

･･････････････････････････････････････････････････････････

･･･････････････････････････････････････････････････････

･･････････････････････････････････････････

･････････････････････････････････････････････

････････････････････････････････････････････････････

･･･････････････････････････････････････････

･････････････････････････････

9-11 9-11 9-12 9-13

9-14 9-15 9-16 9-17

10-1~14

10-1 10-1 10-2 10-2

10-3 10-3

10-3~14

CONTENTS-3

11. CLEANING AND DISINFECTION

･････････････････････････････････････････････････

11-1~8

11.1. Cleaning and disinfection of machine outside

11.1.1. Machine enclosure

11.1.2. Dialysate concentrate connectors and rinse ports

11.2. Cleaning and disinfection of fluid lines

11.3. Disinfection of fluid line inside

11.3.1. Concentration of disinfectant concentrate

11.3.2. Diluted disinfectant concentration and disinfection time

11.3.3. Method to set dilution rate of disinfectant concentrate

11.3.4. Check of residual disinfectant

11.4. Removal of calcium deposit from fluid line inside

11.4.1. Concentration of acetic acid concentrate

11.4.2. Diluted disinfectant concentration and disinfection time

11.4.3. Concentration of acetic acid to be diluted

11.4.4. Method to set dilution rate of acetic acid concentrate

11.4.5. Check of residual acetic acid

11.5. Removal of protein deposit from fluid line inside

11.5.1. Concentration of sodium hypochlorite

11.5.2. Diluted disinfection concentration and disinfection time

11.5.3. Concentration of sodium hypochlorite to be diluted

11.5.4. Check of residual sodium hypochlorite

････････････････････････････････････････････････････････

･･･････････････････････････････････････････

･･････････････････････････････････････････････････

･･･････････････････････････････････････････････

･････････････････････････････････････

･･････････････････････････････････

･････････････････････････････････････

･･･････････････････････････････････

････････････････････････････････････････

･･･････････････････････････････････････

･･････････････････････････････

･････････････････････････

･･････････････････････････

･････････････････････････

･･･････････････････････････

･････････････････････････

････････････････････････････

11-1 11-1 11-1

11-1 11-2

11-2 11-2 11-3 11-3

11-4 11-4 11-4 11-4 11-5 11-5

11-6 11-6 11-6 11-7 11-7

12. PROCESS FLOW

12.1. Process flow

12.2. Description of process flow

12.2.1. Rinse wait process

12.2.2. Rinse process

12.2.2.1. Water rinse mode

12.2.2.2. Disinfection/rinse mode

12.2.2.3. Acid rinse mode

12.2.2.4. Dwelling mode

12.2.2.5. Prerinse mode

12.2.3. Rinse end process

12.2.4. Dialysis wait process

12.2.5. Prepa

12.2.6. Preparation end process

12.2.7. Dialysis process

12.2.8. Recovery process

12.2.9. Air purge process

･･････････････････････････････････････････････････････････････

･････････････････････････････････････････････････････････････････

ration process

12-1~4

･････････････････････････････････････････････････････

････････････････････････････････････････････････････････

････････････････････････････････････････････････････････････

･････････････････････････････････････････････････････

････････････････････････････････････････････････

･･･････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････

･･････････････････････････････････････････････････････

･･･････････････････････････････････････････････････････

･･･････････････････････････････････････････････････

･･････････････････････････････････････････････････････････

･･････････････････････････････････････････････････････････････････････････････････････････････････････････････････

12-1 12-2

12-2 12-2 12-2 12-2 12-2 12-2 12-2 12-3 12-3 12-3 12-3 12-3 12-3 12-3

CONTENTS-4

13. OPERATION OF MACHINE

･･････････････････････････････････････････････････････

13-1~4

13.1. Check and action before turning on power breaker

13.2. Procedures for machine operation

13.2.1. Machine SW ON

13.2.2. Prerinse

13.2.3. Dialysis

13.2.4. Postrinse

13.2.5. Machine power breaker OFF

14. RINSING

14.1. Selection of rinsing mode

14.2. Setting of rinsing pattern (example: RINSE4 (AUTO2 C&D)）

14.3. Connection of concentrates

14.3.1. Connection of concentrates when acid rinse port (option) is not used

･･････････････････････････････････････････････････････････････････････

14.3.1.1. Connection at water rinse

14.3.1.2. Connection at disinfection/rinse

14.3.1.3. Connection at acid rinse

･････････････････････････････････････････････････････････････････

･･････････････････････････････････････････････････････････････････

････････････････････････････････････････････････････････････････

･･････････････････････････････････････････････････････････

･･････････････････････････････････････････････････････

････････････････････････････････････････････････････

･･････････････････････････････････････････････

･･･････････････････････････････････････････････

･･････････････････････････････････････････････

･････････････････････････････････････････

････････････････････････････････････････････････

････････････････････････････････

･･･････････････････････

14-1~6

･･･････････

13-1 13-3

13-3 13-3 13-4 13-4 13-4

14-2 14-2

14-3 14-3

14-3 14-3 14-3

14.3.2. Connection of concentrates when acid port unit (option) is used

14.3.2.1. Connection at water rinse

14.3.2.2. Connection at disinfection/rinse

14.3.2.3. Connection at acid rinse

14.3.2.4. Connection at auto rinse 1 or 2

14.4. Start of rinsing (example: RINSE4(AUTO2 C&D)）

14.5. Completion of rinsing

14.6. Discontinuance of rinsing

15. DOUBLE NEEDLE DIALYSIS

15.1. Setting of dialysate related parameters

15.1.1. Setting of dialysis mode

15.1.2. Setting of dialysate concentration

15.1.2.1. Bicarbonate dialysate

15.1.2.2. Acetate dialysate

15.1.3. Setting of dialysate temperature

･･････････････････････････････････････････････････････････

･･････････････････････････････････････････････････････

･･･････････････････････････････････････････････････

････････････････････････････････････････････････････

･･････････････････････････････････････････････････････

･･････････････････････････････････････････････

･････････････････････････････････････････

････････････････････････････････････････････････

･･････････････････････････････････････････

････････････････････････････････

･･････････････････････････････････････････

･･･････････････････････････････････････････

･･････････････････････････････････････････････････

･････････････････････････････････････････････

･････････････････

15-1~20

14-4 14-4 14-4 14-4 14-4

14-5 14-5 14-6

15-2 15-2 15-2 15-2 15-3 15-3

CONTENTS-5

15.2. Connection of concentrates

15.2.1. Connection of concentrates to prepare bicarbonate dialysa t e

15.2.2. Connection of concentrate to prepare acetate dialysate

････････････････････････････････････････････････････

････････････････････

････････････････････････

15-4 15-4 15-4

15.3. Setting of blood line, dialyzer and syringe

15.3.1. Setting of blood line

15.3.2. Setting of dialyzer

15.3.3. Setting of syringe

15.3.4. Setting of syringe pump

15.3.4.1. Setting of cross-section ratio of syringe

15.3.4.2. Setting of syringe operation stop time

15.3.4.3. Setting of fast-forward volume

15.4. Preparation of machine (preparation process)

15.5. Check of preparation completion of machine (preparation end process)

15.6. Priming process

15.6.1. Setting of saline vial

15.6.2. Priming of saline

15.6.3. Priming of dialyzer with dialysate

15.6.4. Rinsing of blood line and dialyzer

15.6.4.1. When priming function is used

15.6.4.2. When priming function is not used

･･････････････････････････････････････････････････････････････

･･･････････････････････････････････････････････････････

･･････････････････････････････････････････････････････････････････････････････････････････････････････････････････

････････････････････････････････････････････････････

･･･････････････････････････････････････････････････････

･･････････････････････････････････････････････････････････

････････････････････････････････････････

･･･････････････････････････････････

････････････････････････････････････

･･･････････････････････････････････････････

････････････････････････････････････

･･････････････････････････････････････････

･････････････････････････････････････････

････････････････････････････････････････

･････････････････････････････････････

･･････････････

15-5 15-5 15-5 15-5 15-5 15-5 15-7 15-7

15-8 15-8 15-9

15-9

15-9 15-10 15-10 15-10 15-11

15.7. Check of dialysate conductivity

15.8. Setting of UF related parameters

15.9. Connection of patient

15.10. Start of dialysis (dialysis process)

15.10.1. Start of dialysis

15.10.2. Setting of upper and lower venous pressure alarm limits

15.10.3. Setting of upper and lower arterial pressure alarm limits

15.10.4. Setting of upper and lower dialysate pressure alarm limits

15.11. Completion of dialysis (recovery process)

15.11.1. Check of UF completion

15.11.2. Start of blood recovery

15.11.3. Execution of blood recovery

15.11.4. Removal of coupler

15.11.5. Cle

15.11.6. Completion of blood recovery

15.12. Discontinuance of dialysis

15.12.1. Discontinuance of UF

15.12.2. Discontinuance of dialysis

aring away

･･･････････････････････････････････････････････････････

････････････････････････････････････････････････････････

･････････････････････････････････････････････････････････

･･･････････････････････････････････････････････

･････････････････････････････････････････････

････････････････････････････････････････････

･････････････････････････････････････

････････････････････････････････････････････････

･･････････････････････････････････････････････････

･････････････････････････････････････････････

････････････････････････････････････････････････････

････････････････････････････････････････････

･･････････････････････････････････････････････････

･･･････････････････････････････････････････････････

･･･････････････････････････････････････････････

･･････････････････････････････････････････

･･･････････････････

15-12 15-12 15-13 15-14

15-14 15-14 15-14 15-15

15-16 15-16 15-16 15-17 15-17 15-18 15-18

15-19 15-19 15-19

CONTENTS-6

16. SINGLE NEEDLE DIALYSIS

････････････････････････････････････････････････････

16-1~20

16.1. Setting of dialysate related parameters

16.1.1. Setting of dialysis mode

16.1.2. Setting of dialysate concentration

16.1.2.1. Bicarbonate dialysate

16.1.2.2. Acetate dialysate

16.1.3. Setting of dialysate temperature

16.2. Connection of concentrates

16.2.1. Connection of concentrates to prepare bicarbonate dialysa t e

16.2.2. Connection of concentrate to prepare acetate dialysate

16.3. Setting of blood line, dialyzer and syringe

16.3.1. Setting of blood line

16.3.2. Setting of dialyzer

16.3.3. Setting of syringe

16.3.4. Setting of syringe pump

16.3.4.1. Setting of cross-section ratio of syringe

16.3.4.2. Setting of syringe operation stop time

16.3.4.3. Setting of fast-forward volume

････････････････････････････････････････････････････

･･････････････････････････････････････････････････

･･････････････････････････････････････････････････････

････････････････････････････････････････････････････

･････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････

････････････････････････････････････････････････････

･･････････････････････････････････････････

･･･････････････････････････････････････････

･････････････････････････････････････････････

････････････････････････････････････････

･･･････････････････････････････････

････････････････････････････････････

･･･････････････････････････････････････････

････････････････････

････････････････････････

16-2 16-2 16-2 16-2 16-3 16-3

16-4 16-4 16-4

16-5 16-5 16-5 16-5 16-6 16-6 16-7 16-7

16.4. Preparation of machine (preparation process)

16.5. Check of preparation completion of machine (preparation end process)

16.6. Priming process

16.6.1. Setting of saline vial

16.6.2. Priming of saline

16.6.3. Priming of dialyzer with dialysate

16.6.4. Rinsing of blood line and dialyzer

16.6.4.1. When priming function is used

16.6.4.2. When priming function is not used

16.7. Check of dialysate conductivity

16.8. Setting of UF related parameters

16.9. Connection of patient

16.10. Setting of single needle dialysis related parameters

16.10.1. Single needle SW ON

16.10.2. Setting of single needle changeover values

16.11. Start of dialysis (dial

16.11.1. Start of dialysis

･･････････････････････････････････････････････････････････････

･･･････････････････････････････････････････････････････

･･････････････････････････････････････････････････････････

･･････････････････････････････････････････

･････････････････････････････････････････

････････････････････････････････････････

･･･････････････････････････････････････････････

･････････････････････････････････････････････

･･･････････････････････････････････････････････････････

･･････････････････････････････････････････････････

ysis process)

････････････････････････････････････････････････････････

････････････････････････････････････････････

････････････････････････････････････

･････････････････････････････････････

････････････････････････････

････････････････････････････････

･･････････････

16-8 16-8 16-9

16-9

16-9 16-10 16-10 16-10 16-11

16-12 16-12 16-13 16-14

16-14 16-14

16-15 16-15

CONTENTS-7

16.11.2. Setting of upper and lower arterial pressure alarm limits

16.11.3. Setting of upper and lower dialysate pressure alarm limits

･････････････････････

･･･････････････････

16-15 16-16

16.12. Completion of dialysis (recovery process)

16.12.1. Check of UF completion

16.12.2. Start of blood recovery

16.12.3. Execution of blood recovery

16.12.4. Removal of coupler

16.12.5. Clearing away

16.12.6. Completion of blood recovery

16.13. Discontinuance of dialysis

16.13.1. Discontinuance of UF

16.13.2. Discontinuance of dialysis

17. SEQUENTIAL DIALYSIS

17.1. ON setting of sequential dialysis

17.2. OFF setting of sequential dialysis

･････････････････････････････････････････････････････････

････････････････････････････････････････････････････････

････････････････････････････････････････････････

･･････････････････････････････････････････････････

････････････････････････････････････････････････････

･･････････････････････････････････････････････････

･･･････････････････････････････････････････････････

･････････････････････････････････････

･････････････････････････････････････････････

････････････････････････････････････････････

･･･････････････････････････････････････････････

････････････････････････････････････････････････

･･･････････････････････････････････････････････

16-17 16-17 16-17 16-18 16-18 16-19 16-19

16-20 16-20 16-20

17-1~2

17-1

18. CHECK AND MAINTENANCE

18.1. Check and maintenance by operator

18.1.1. Check and maintenance before and after operation

18.1.1.1. Test mode

18.1.2. Cleaning and disinfection of machine outside

18.1.3. Disinfection and rinsing of fluid line inside

18.1.4. Acetic acid rinsing of fluid lines

18.2. Regular check by engineer

18.2.1. Check before power ON

18.2.2. Check of leakage current

18.2.3. Check of accuracy of pressure sensor

18.2.4. Check of syringe pump

18.2.4.1. Check for fixation of pulley

18.2.4.2. Check for accuracy of syringe pump

18.2.5. Check of accuracy of UF

18.2.6. Check of accuracy of blood leak sensor

18.2.6.1. Visual check of blood leak sensor

18.2.6.2. Zero revisions of blood leak sensor

18.2.7. Che

18.2.7.1. When electronic balance is used

18.2.7.2. When measuring cylinder is used

ck of accuracy of blood pump flow rate

･･･････････････････････････････････････････････････

････････････････････････････････････････････････････････････

18-1~22

････････････････････････････････････････････

････････････････････････････

･････････････････････････････････

････････････････････････････････････

･･････････････････････････････････････････････

･････････････････････････････････････････････････････

･･････････････････････････････････････････････････････････････････････････････････････････････････････

･･･････････････････････････････････････

･･･････････････････････････････････････････････････

･･････････････････････････････････････････････

･････････････････････････････････････

･･･････････････････････････････････････････････････

･･････････････････････････････････････

････････････････････････････････････････

･･･････････････････････････････････

･････････････････････････････････････････････････････････････････････････････････････････････････････････････

18-1 18-1 18-1 18-2 18-2 18-2

18-3 18-4 18-5 18-6 18-7 18-7 18-7 18-8 18-9

18-9 18-10 18-11 18-11 18-11

CONTENTS-8

18.2.8. Check of accuracy of bubble sensor

18.2.8.1. Preferable method

18.2.8.2. Simple method

18.2.9. Check of accuracy of temperature sensor

18.2.10. Check of accuracy of conductivity cell

18.2.11. Replacement of components of GVS filter (Supply water line)

18.2.12. Replacement of components of electromagnetic valve

18.2.13. Replacement of component of pump

18.2.13.1. Overall views of pump

18.2.13.2. Contents parts list

18.2.13.3. Replace method

･･･････････････････････････････････････････････････

･･････････････････････････････････････････････････････

･････････････････････････････････････････････

･･････････････････････････････････････････････････

･･･････････････････････････････････････････････････

･･･････････････････････････････････････

･･････････････････････････････････

･････････････････････････････････････

･･････････････････････

･･････････････････････････････････････

････････････････

18-12 18-12 18-12 18-13 18-14 18-15 18-16 18-18 18-18 18-18 18-20

18.3. Maintenance by qualified engineer

19. STORAGE

19.1. Actions before storing machine

19.1.1. Cleaning of enclosure

19.1.2. Priming of formalin solution

19.2. Environmental conditions required to store machine

19.3. Check and test before re-operation of machine

･････････････････････････････････････････････････････････････････････

･････････････････････････････････････････････････････

････････････････････････････････････････････

･････････････････････････････････････････････････

20. MACHINE MOVING AND CAUTIONS

21. SPECIFICATIONS

･････････････････････････････････････････････････････････････

･････････････････････････････････････････････

19-1~2

･･･････････････････････････････

･･･････････････････････････････････

20-1~2

21-1~12

18-22

19-1

19-2

21.1. Specifications for machine

21.1.1. Dimension and weight

21.1.2. Power source

21.1.3. Electric safety

21.1.4. Environment

21.2. Performance of machine

21.2.1. Dialysate flow rate

21.2.2. Deaeration

21.2.3. UFR control

21.2.4. Temperature control

21.2.5. Conductivity control (BICARBONATE）

21.2.6. Conductivity control (ACETATE)

21.2.7. Disinfection control

････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････

･････････････････････････････････････････････････････････････

･･･････････････････････････････････････････････････････････････

･･････････････････････････････････････････････････････････････

･･････････････････････････････････････････････････････････････････････････････････････････････････････････

･･･････････････････････････････････････････････････････

････････････････････････････････････････････････････････

･･･････････････････････････････････････････････････････

････････････････････････････････････････････

････････････････････････････････････････････････････････

･･････････････････････････････････････

CONTENTS-9

21-1

21-2

21-3

21-4

21-5

21.2.8. Acid rinse control

21.2.9. Water rinse control

21.2.10. Blood pump

21.2.11. Syringe pump

･････････････････････････････････････････････････････････････

･･･････････････････････････････････････････････････････････

･････････････････････････････････････････････････････････

････････････････････････････････････････････････････････

21-5

21-6

21.3. Safety monitors

21.3.1. Venous pressure monitor

21.3.2. Dialysate pressure monitor

21.3.3. Bubble detector

21.3.4. Blood leak detector

21.3.5. Temperature monitor

21.3.6. Conductivity monitor

21.4. Specifications for options

21.4.1. Arterial pressure sensor

21.4.2. Backup unit of blood pump for power failure

21.4.2.1. Machine specification

21.4.2.2. Energy cell specification

21.4.3. Heat exchanger

21.4.4. Acid rinse port unit

21.4.5. Hot rinse Assy

21.4.5.1. Hot chemical disinfectant rinse control

21.4.5.2. Hot water rinse

21.4.6. Large single lump assy

･･････････････････････････････････････････････････････････････

･･････････････････････････････････････････････････

･････････････････････････････････････････････････

･･･････････････････････････････････････････････････････････

････････････････････････････････････････････････････････

･･････････････････････････････････････････････････････

･･･････････････････････････････････････････････････････

･･････････････････････････････････････････････････････

････････････････････････････････････････････････････

･･････････････････････････････････････････････････

････････････････････････････････････････････････

･････････････････････････････････････････････････････････

･･････････････････････････････････････････････････････

･･････････････････････････････････････････････････････････

･･････････････････････････････････････････････････････

･･････････････････････････････････････････････････

･･････････････････････････････････

21-7

21-8

21-9

21-9 21-10 21-10 21-10 21-10 21-11 21-11

21.5. Special note

21.5.1. Language

･･･････････････････････････････････････････････････････････････

･･････････････････････････････････････････････････････････････

22. DATA FOR USE

22.1. Blood tubing set applicable to SURDIAL

22.1.1. A065(A067) / V643

22.1.2. A064(A066) / V643

22.2. Layouts of blood tubing

22.2.1. Model A065(A067) / V643

22.2.2. Model A064(A066) / V643

22.3. Flow chart and components of SURDIAL

22.3.1. Flow chart

22.3.2. Component of SURDIAL

････････････････････････････････････････････････････････････････

････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････････

････････････････････････････････････････････････････････････････････････････････････････････････････

･･･････････････････････････････････････････････････････････････

･･･････････････････････････････････････････････････

22-1~8

･････････････････････････････････････････

21-11 21-11

22-1

22-2

22-4

22-5

22-6

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

Cautions during operation

4. (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:

z “Acetate” means salt required to prepare acetate dialysate which is used for acetate

dialysis.

z “Acid rinsing” means process to rinse dialysate line by passing dilute acetic acid

through it.

z "Arterial pressure (option)" means pressure in arterial drip chamber determined by

pressure sensor connected with the chamber through detection line.

z “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.

z "Bicarbonate" means salt required to prepare bicarbonate dialysate which is used

for bicarbonate dialysis.

z “Blood leak detector” means device used to detect blood leak to dialysate optically. z “Blood line” means the circuit used to circulate extracorporeal blood through

dialyzer.

z “Blood pump” means pump used to circulate blood through dialyzer and blood line.

Roller type pump is used in SURDIAL.

z “Bubble detector” means device used to detect air bubble in blood passing through

venous line.

z “Bypass” means process to drain dialysate through bypass line without passing

dialysate through dialyzer.

z “Clamp” means device used to close blood line by clamping when air bubble is

detected in venous line.

z "Concentration" means Na+ concentration in dialysate derived from measurement

of dialysate conductivity.

z “Conductivity sensor” means the sensor used to measure conductivity of dialysate. z "Dialysate" means solution dissolving various salt used to remove metabolic waste

and excess fluid from blood through dialyzer membrane.

z “Dialysate concentrate connection ports” means those provided with male

connectors each used to connect with each of acetate or A and B concentrates.

z "Dialysate pressure: DP" means pressure at dialyzer inlet determined by referring to

pressure measured at dialysate line by pressure sensor.

z "Dialysis" means process to remove metabolic waste and excessive fluid from a

circulating extracorporeal blood by diffusion.

z “Dialyzer” means device containing membrane through which metabolic waste and

4-1

excess fluid are removed.

z DIALYSIS screen : PREPARATION COMPLETION, DIALYSIS and RECOVERY are

enabled by the mode.

z “Disinfection” means process to disinfect dialysate line by passing disinfectant

such as dilute sodium hypochlorite or peracetic acid solution through it. z “Disinfectant concentrate connection port” means that provided with male

connector used to connect with disinfectant. z "Double needle dialysis" means dialysis performed by puncturing artery and vein

using respective needles to circulate blood.

z “Earth” means ground connection. z PREPARATION screen : message to operator is displayed during preparation

process.

z “Priming” means process to prime dialyzer with saline or the like. z RINSING (AUTOMATIC RINSING 1) screen : pattern of the disinfection and current

time are displayed. z RINSING (AUTOMATIC RINSING 2) screen : pattern of the disinfection and current

time are displayed. z “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. z RINSING WAITING screen : list of rinsing patterns is displayed and desired rinsing

mode is selected by the mode.

z RINSING (WATER RINSING) screen : the mode is displayed. z "Sequential dialysis" means execution of ultrafiltration only without passing

dialysate through dialyzer. z "Single pump-single needle dialysis" means dialysis performed by puncturing

arteriovenous fistula using single needle under operating of single pump. z “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. z “Temperature sensor” means the sensors used to measure temperature of supply

water at 2 locations and dialysate at 1 locations.

z "Transmembrane pressure: TMP" means [venous pressure] - [DP].

z TMP is for reference only.

z “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. z "Ultrafiltration" means process to remove fluid from a circulating extracorporeal

blood through dialyzer membrane. z "Venous pressure" means pressure in venous drip chamber determined by

pressure sensor connected with the chamber through detection line. z “Viscous control system” means system used to prepare dialysate and to control

UF. The principle are next section.

4-2

z “Viscous pump” means bellowphragm pump receiving viscous silicone used to

control ultrafiltration (UF) and to prepare dialysate. z “Water rinsing” means process to rinse dialysate line by passing water through it.

4-3

z 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 Required condition

Allowable set range

Allowable indication range

Accuracy of indicated value

-400～+400mmHg

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

Temp. (°C)

15 to 35 10 to 40 5 to 50 -10 to 50

Storage for one month

or more; and Transport

with contained fluid

Transport

without fluid

Relative humidity

(%)

Atmospheric

pressure (hPa)

35 to 80 15 to 85 15 to 85 15 to 85

No condensing

795 to

1062

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

2

Pressure : 0.049 to 0.74 MPa (0.5 to 7.5 kgf/cm

)

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

6-2

 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.

6.1.4.5. 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)

Fig.6-1 Accessories

(L) CL filter (×1)

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

6-6

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

6.3.3. 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  For A or B concentrate

container container

Fig. 6-3 Connectors for concentrate containers

Fig. 6-4 Preparation of suction port

Cut off

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.

［ＭＡＩＮＴＥ ＭＥＮＵ（４／５）］  ＭＯＤＥ９：ＭＡＣＨＩＮＥ ＦＩＬＬＩＮＧ ＰＲＯＣＥＤＵＲＥ  ＭＯＤＥ１０：ＡＬＡＲＭ ＨＩＳＴＯＲＹ   ＭＯＤＥ９   ＭＯＤＥ１０  Ｐ．ＵＰ   Ｐ．ＤＯＷＮ   ＤＩＳＰ．



Ｆ・１Ｆ・２Ｆ・３Ｆ・４  Ｆ・５

［ＭＡＩＮＴＥ ９］   ＧＯ ＴＯ ＲＩＮＳＥ ＷＡＩＴＩＮＧ ＭＯＤＥ   ＰＲＥＳＳ ＳＴＡＲＴ ＳＷ ＴＯ ＦＩＬＬ ＭＡＣＨＩＮＥ  ＳＴＡＲＴＭＥＮＵ  



Ｆ・１Ｆ・２Ｆ・３Ｆ・４  Ｆ・５

［ＭＡＩＮＴＥ ９］   ＦＩＬＬＩＮＧ    ＳＴＯＰ



Ｆ・１Ｆ・２Ｆ・３Ｆ・４  Ｆ・５

［ＭＡＩＮＴＥ ９］   ＥＮＤ ＯＦ ＦＩＬＬＩＮＧ  ＭＥＮＵ  



Ｆ・１Ｆ・２Ｆ・３Ｆ・４  Ｆ・５

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

Main

Operation

Blood line setting

Front view

Fig. 8-1-1 Front and right side views of SURDIAL

8-1

Right side

y

Power suppl

Rear side view Left side view

Fig. 8-1-2 Rear and left side views of SURDIAL

8-2

V

8.1.2 Components of machine and their purposes and functions

No. Component Purpose and function

1 Sampling port

2 Rinse port for A

concentrate

3 Connector for A

concentrate

4 Rinse port for B

concentrate

5 Connector for B

concentrate

6 Flow meter

7 Dialysate return tube Tube used to return used dialysate to port “From

8 Dialysate supply tube Tube used to supply fresh dialysate to port “To

9 Dialysate return coupler

10 Dialysate supply coupler Coupler used to connect fresh dialysate supply tube to

11 Bypass connector Connector used to bypass ports “From Dialyzer” and

12 Limit SW for bypass

connector

13 Coupler holder

14 Dialysate flow rate

regulating needle valve

15 Container support

16 Port “From Dialyzer”

17 Port “To Dialyzer”

Port used to take dialysate sample

Port used to connect to connector of A concentrate container during rinsing operation Connector used to connect connector of bicarbonate A concentrate container

Port used to connect connector of B concentrate container during rinsing operation Connector used to connect connector of bicarbonate B concentrate container

Meter use to indicate flow rate of dialysate supplied to dialyzer

Dialyzer”

Coupler used to connect used dialysate return tube to dialyzer

dialyzer

“To Dialyzer” when couplers Nos. 9 and 10 are set to the machine during rinsing operation SW used to detect whether coupler is received in coupler holder Holder used to receive coupler during rinsing operation

alve used to regulate dialysate flow rate in closed circuit Support used to load dialysate concentrate container

Port used to return used dialysate from dialyzer

Port used to supply fresh dialysate to dialyzer

8-3

No. Component Purpose and function

18 Water supply port

19 Drain port

20 Port for connector of

disinfectant concentrate connector

21 Connector for disinfectant

concentrate container

22 Blood leak sensor

23 Priming flow rate regulating

needle valve

24 Tray

Port used to connect hose for supplying purified water to the machine Port used to connect hose for draining used dialysate

Port use to connect connector of disinfectant concentrate container when disinfectant or acid rinsing is not executed Connector used to connect disinfectant concentrate container during disinfection/rinsing; or that used to connect acetic acid concentrate container during acid rinsing Sensor used to detect blood leak

Valve used to regulate flow rate of priming solution

Tray used to hold tools during dialysis by placing it on the machine top

8-4

8.2 Operation panel

8.2.1 Construction of operation panel

Fig. 8-2 Operation panel

8-5

8.2.2 Components of operation panel and their purposes and functions

No. Component Purpose and function

1 [DIALYSIS] SW with lamp SW used to start dialysis

“During dialysis preparation” and “enabled dialysis start” is indicated by lamp lighting.

2 [PREP.] SW with lamp SW used to prepare dialysate and to prepare to start air

purge “Preparation end” or “during recovery” is indicated b y lamp lighting. “During preparation” is indicated by lamp flashing.

3 [UF DIALYSE] SW with

lamp

4 [BYPASS] SW with lamp SW used to bypass dialysate without passing through

5 [DRAIN] SW

6 [RINSE] SW with lamp SW used to start rinsing of fluid lines of the machine

7 CONDITION lamp Lamp used to indicate operating condition

8 [MUTE] SW with lamp “Alarm actuation” is indicated by lamp lighting. By

9 [RESET] SW with lamp “Alarm actuation” is indicated by lamp lighting. By

10 POWER lamp

11 Display Display used to show dialysate temperature, VP, DP and

12 Venous pressure indicator Indicator used to show VP by bar graph

13 Set upper VP limit

increasing SW

14 Set upper VP limit

decreasing SW

SW used to start UF “During UF” is indicated by lamp lighting.

dialyzer “During manual bypassing” is indicated by lamp lighting. “During automatic bypassing” is indicated by lamp flashing. SW used to drain dialysate from dialyzer

“During rinsing” is indicated by lamp lighting.

“During UF” is indicated by green lighting and “during alarm actuation” is indicated by red lighting.

pressing SW, buzzing is muted and lamp is OFF.

pressing SW after muting buzzer, alarm is released and lamp is OFF. “Power SW ON” is indicated by lamp lighting.

alerted condition, etc. for monitoring them.

Upper and lower limits of set VP range are also shown by different colors. SW used to increase set upper VP limit within acceptable range SW used to decrease set upper VP limit within acceptable range

8-6

No. Component Purpose and function

15 Set lower VP limit

increasing SW

16 Set lower VP limit

decreasing SW

SW used to increase set lower VP limit within acceptable range SW used to decrease set lower VP limit within acceptable range

17 DP/AP indicator Indicator used to show DP or AP (option) by bar graph

Upper and lower limits of set DP or AP range are also shown by different colors.

18 DP indication lamp Lamp used to indicate that DP is shown in DP/AP

indicator

19 AP indicator lamp Lamp used to indicate that AP is shown in DP/AP

indicator

20 Set upper DP/AP limit

increasing SW

21 Set upper DP/AP limit

decreasing SW

22 Set lower DP/AP limit

increasing SW

23 Set lower DP/AP limit

decreasing SW

SW used to increase set upper DP or AP limit within acceptable range SW used to decrease set upper DP or AP limit within acceptable range SW used to increase set lower DP or AP limit within acceptable range SW used to decrease set lower DP or AP limit within acceptable range

24 Conductivity indicator Indicator used to show conductivity by bar graph

Upper and lower limits of set conductivity range are also shown by different colors.

25 Total UF volume indicating

LED

26 [UF RESET] SW

LED used to indicate total UF volume at this time digitally SW used to reset total UF volume indicating LED

27 Target UF volume

LED used to indicate set target UF volume digitally

indicating LED

28 Set target UF volume

SW used to increase set target UF volume

increasing SW

29 Set target UF volume

SW used to decrease set target UF volume

decreasing SW

30 UFR indicating LED

LED used to indicate set UFR digitally

31 Set UFR increasing SW

SW used to increase set UFR

32 Set UFR decreasing SW

SW used to decrease set UFR

33 Left time indicating LED

LED used to indicate left dialysis time at this time digitally

8-7

No. Component Purpose and function

34 Set left time increasing SW SW used to increase displayed left dialysis time

digitally

35 Set left time decreasing SW SW used to decrease displayed left dialysis time

digitally

36 FUNCTION 1 SW SW used to set various parameters

Set data is indicated in message screen.

37 FUNCTION 2 SW SW used to set various parameters

Set data is indicated in message screen.

38 FUNCTION 3 SW SW used to set various parameters

Set data is indicated in message screen.

39 FUNCTION 4 SW SW used to set various parameters

Set data is indicated in message screen.

40 FUNCTION 5 SW SW used to set various parameters

Set data is indicated in message screen.

41 Bubble sensor activating

SW with lamp

42 Syringe pump fast infusion

SW use to activate bubble sensor Sensor activation is indicated by lamp lighting. SW use to operate syringe pump at fast infusion rate

SW

43 Syringe pump flow rate

LED used to indicate flow rate of syringe pump digitally

indicating LED

44 Set syringe pump flow rate

SW used to increase set syringe pump flow rate

increasing SW

45 Set syringe pump flow rate

SW used to decrease set syringe pump flow rate

decreasing SW

46 Syringe pump operating

SW with lamp

47 Blood pump flow rate

SW used to operate syringe pump Pump operation is indicated by lamp lighting. LED used to indicate BP flow rate digitally

indicating LED

48 Blood pump flow rate

Volume used to set BP flow rate

setting volume

49 Blood pump operating SW

with lamp

SW used to operate blood pump Pump operation is indicated by lamp lighting.

8-8

8.3 Blood line setting panel

8.3.1 Construction of blood line setting panel

Fig. 8-3 Blood line setting panel

8-9

8.3.2 Components of blood line setting panel and their purposes and functions

No. Component Purpose and function

1 Blood pump rotor Rollers used to deliver blood by squeezing blood line

tube

2 Blood pump cover Cover used to protect rotating mechanism of BP

BP operation stop is caused by opening cover.

3 Blood pump cover SW SW used to monitor opening of BP cover

4 Bubble detector Detector used to detect bubble in blood line

5 Clamp Clamp used to close blood line tube for blood flow stop

6 Tube holder Holder used to set blood line tube

7 Venous pressure inlet port Port used to introduce venous pressure for its

measurement

8 Pusher Used to advance syringe plunger

Engageable with the plunger by receiving its flange in it Release of lock by pushing in, enabling manual right or left movement

9 Syringe holder Used to hold syringe

10 Syringe holding lever Used to hold syringe in syringe holder by rotation

Syringe holding by rotating it to cross syringe and release of the holding by parallel placement of it with syringe

8-10

8.4 Power supply

8.4.1 Construction of power supply

Fig. 8-4 Power supply

8-11

8.4.2 Components of power supply and their purposes and functions

No. Component Purpose and function

1 Power cord Cord having power plug at its distal end

2 Power SW Power SW of the machine

3 Buzzer Buzzer used to alert error audibly

4 DC24V OUT Service connector for manufacture

5 RS-232C Service connector for manufacture 6 BP BACKUP Volume used to set BP flow rate at power failure

(Enabled only when required option is used）

7 Fan Fan used to ventilate power box inside

8 Air filter Filter used to remove dust from air introduced into

Electrical POWER BOX.

8-12

8.5 Main lamp assembly

8.5.1 Construction of main lamp assembly

Fig. 8-5 Main lamp assembly

8-13

8.5.2 Components of main lamp assembly and their purposes and functions

No. Component Purpose and function

1 Main lamp

2 Hanger

3 I.V. pole

4 Set screw

O-ring (×2)

5

6 Main lamp cap

Lamp used to alert error visually

Hanger used to suspend vial and the like

Pole used to hold dialyzer and the like

Screw used to fix hanger to I.V. pole

Rings used to cushion fixed hanger

Cap used to support main lamp

8-14

Chapter 9 DISPLAY

LCD is used to display various dialysis related information and parameter setting screens in

area of 40 letters×4 lines.

Many information and parameter setting screens are available. Desired mode screen can be

displayed by SW operation on operation panel.

[F･5] SW (DISP.) Rinsing operation screen (9.3) [F･5] SW (DISP.) Dialysis operation screen (9.4)

SettingⅠscreen (9.5) Alarm screen (9.8) ※ Only when alarm is actuated

[F 5] SW (DISP.)

･

[F

･

5] SW (DISP.)

SettingⅡscreen (9.6) Maintenance [F･5] (DISP.) SW menu screen (9.7)

[F

(MODE

1][F 2] SW

＊

)

…See “Service Manual”. Maintenance 1-10 screens

Fig. 9-1 Screen flow

･

[F 5] SW (MENU)

･

9-1



ＣＡＵＴＩＯＮ

z LCD is easily damaged. Do not press or scratch its surface by pencil point or any hard

tool.

z LCD is mainly constructed by glass. Do not give impact to it. z Do not press operation panel SW by pencil point or any hard tool.

9-2

9.1. Layout of display

Areas from①to⑨are allocated to LCD screen to display information specified for each of

them.

① ② ③

④

⑤ ⑥ ⑦ ⑧ ⑨

Fig. 9.2 Layout of display

① Title display area

Title of currently selected mode is displayed.

② Operation display area 1

One of operation types such as SINGLE.N and SQHD is displayed as shown in the left side of the below Table. Procedure to display each of the types is shown in the right side of the Table.

SINGLE.N Turn on single needle SW.

SQHD Turn on sequential HD SW. CONSOLE Select console mode in maintenance mode 7. ERR FREE Release any of alarms in maintenance mode 3.

③ Operation display area 2

One of operation types such as draining and UF is displayed as shown in the left side of the below Table. Condition required to display each of the types is shown in the right side of it.

UF During UF execution.

BP Stop During BP SW is ON, while BP is stopped.

Drain During draining.

FlowStop During fluid flow stop due to alarm actuation.

GasParge During gas purging (excluding dialysis process).

Standby During preparation process

Bypass During bypassing (excluding auto bypass in dialysis wait

process)

MIN.UF During minimum UF execution

Wait During rinse wait process

Rinse During rinse process

End During rinse end process

④ Setting/information display area

Rinse screen (rinse wait, rinse, rinse end wait), dialysis screen (dialysis wait,

9-3

preparation, preparation end, dialysis, recovery) and various setting screens (settingⅠ, settingⅡ, maintenance) are displayed.

9-4

⑤ [F･1] SW function display area

[F･1] SW functions are displayed.

⑥ [F･2] SW function display area

[F･2] SW functions are displayed.

⑦ [F･3] SW function display area

[F･3] SW functions are displayed.

⑧ [F･4] SW function display area

[F･4] SW functions are displayed.

⑨ [F･5] SW function display area

[F･5] SW functions are displayed.

9-5

9.2 Wake up screen

This screen is displayed for several seconds by turning on power SW.

ＳＩＮＧＬＥＰＡＴＩＥＮＴＤＩＡＬＹＳＩＳＭＡＣＨＩＮＥＳＵＲＤＩＡＬＴＹＰＥ Ⅱ ＮＩＰＲＯＣＯＲＰＯＲＡＴＩＯＮＲＡＭ：ＯＫＲＯＭＶｅｒ．３．００／０１ＲＯＭ：ＯＫ

Fig. 9-3 Rise screen

INDICATION DESCRIPTION

SINGLE PATIENT DIALYSIS MACHINE Machine name SURDIAL Machine type NIPRO CORPORATION Manufacturer name ROM Ver. ROM version No. RAM RAM check result ROM ROM check result



ＣＡＵＴＩＯＮ

z Any specifications and functions may not be provided according to the machine version

No. To know the details, contact our branch or representative near your place.

9-6

9.3 Rinse screen

9.3.1 Rinse menu

Rinse menu is used to select and register rinse mode.

Press any of [F･1] to[F･4] SW’s to select desired rinse mode. Press [F･5] SW to display settingⅠscreen.

［ＲＩＮＳＥＭＥＮＵ］ＲＩＮＳＥ１：ＷＡＴＥＲＲＩＮＳＥ３：ＡＵＴＯ１Ｃ＆ＤＲＩＮＳＥ２：ＣＨＥＭＩＣＡＬＲＩＮＳＥ４：ＡＵＴＯ２Ｃ＆ＤＲＩＮＳＥ１ＲＩＮＳＥ２ＲＩＮＳＥ３ＲＩＮＳＥ４ＤＩＳＰ．

Fig. 9-2 Rinse menu screen

INDICATION DESCRIPTION

RINSE1:WATER Mode to execute water rinse only RINSE2:CHEMICAL Mode to execute disinfection/rinse only RINSE3:AUTO1 C&D Mode to execute programmed rinse RINSE4:AUTO2 C&D Mode to execute programmed rinse

9-7

9.3.2 Rinse wait

When rinse wait mode is selected, rinse mode and time to be executed are displayed.

Information displayed together with the mode and time is defined by selected rinse mode.

9.3.2.1 RINSE1: WATER

Press [F･1] or [F･2] SW to change rinse time only.

Press [F･5] SW to display rinse menu.

［ＲＩＮＳＥ１］２０：１５＜Ｗａｉｔ＞ＷＡＴＥＲＲＩＮＳＥ３０ｍｉｎ

＋－ＭＥＮＵ

Fig. 9-5 Rinse wait screen when RINSE1 is selected

9.3.2.2 RINSE2:CHEMICAL

Press [F･1] or [F･2] SW to change rinse time only.

［ＲＩＮＳＥ２］２０：１５＜Ｗａｉｔ＞ＣＨＥＭＩＣＡＬＲＩＮＳＥ３０ｍｉｎ

＋－ＭＥＮＵ

Fig. 9-6 Rinse wait screen when RINSE2 is selected

9.3.2.3 RNSE3:AUTO1 C&D

Press [F･3] or [F･4] SW to shift blink to desired position and press [F･1] or [F･2] SW to

change setting.

Details are same as the case of『RINSE4:AUTO2 C&D』.

［ＲＩＮＳＥ３］２０：１５＜Ｗａｉｔ＞ＷＴＲ３０→ＣＨＭ３０→ＤＷＬ３０→ＰＲＥ３０→－－－－－→－－－－－ＰＲＥＲＩＮＳＥＳＴＡＲＴＴＯＭＯＲＲＯＷ１０：００＋－＜＞ＭＥＮＵ

Fig. 9-7 Rinse wait screen when RINSE3 is selected

9-8

9.3.2.4 RINSE4: AUTO2 C&D

Press [F･3] or [F･4] SW to shift blink to desired position and press [F･1] or [F･2] SW to

change setting.

Rinse program and time can be changed.

［ＲＩＮＳＥ４］２０：１５＜Ｗａｉｔ＞ＷＴＲ３０→ＣＨＭ３０→ＤＷＬ３０→ＰＲＥ３０→－－－－－→－－－－－ＰＲＥＲＩＮＳＥＳＴＡＲＴＴＯＭＯＲＲＯＷ１０：００＋－＜＞ＭＥＮＵ

Fig. 9-8 Rinse wait screen when RINSE4 is selected

INDICATION DESCRIPTION

WTR※※ Execution of water rinse for ※※ min CHM※※ Execution of disinfection/rinse for ※※ min ACD※※ Execution of acid rinse for ※※ min DWL※※ Execution of dwelling for ※※ min PRE※※

－－－－－

PRERINSE START Setting of prerinse start time within period from this

Start of prerinse at time set by PRERINSE START No operation

time to 6 days after it

ＮＯＴＥ

z If acid rinse port unit (option) is not set to the machine, simultaneous setting of both

disinfection/rinse and acid rinse is disabled.

z If program adversely affecting the machine operation; for example, program to execute

disinfection/rinse and acid rinse in sequence; or that including no prerinse or no water rinse step after rinse completion is set, rinsing operation can not be started even by pressing RINSE SW.

z Refer to the option manual for setting hot rinse function. Set up hot water rinse (HWR)

and hot chemical disinfectant rinse require the machine already have hot rinse option.

9-9

9.3.3 Rinse execution

During rinse progress, rinse step at that time is displayed. Displayed information is defined

by selected rinse mode.

ＮＯＴＥ

z If any SW on operation panel is not pressed for ≧30 minutes during prerinse wait

process, back light is automatically turned off. By pressing the SW or by starting prerinse, the light is ON.

9.3.3.1 RINSE1: WATER

By rinse advancement, indicated rinse time is reduced to show left rinse time. Press [F･5] SW to display settingⅠscreen.

［ＲＩＮＳＥ１］２０：３０＜Ｒｉｎｓｅ＞ＷＡＴＥＲＲＩＮＳＥ１５ｍｉｎ

ＤＩＳＰ．

Fig. 9-9 Rinse execution screen when RINSE1 is selected

9.3.3.2 RINSE2: CHEMICAL

By rinse advancement, indicated rinse time is reduced to show left rinse time.

［ＲＩＮＳＥ２］２０：３０＜Ｒｉｎｓｅ＞ＣＨＥＭＩＣＡＬＲＩＮＳＥ１５ｍｉｎ

ＤＩＳＰ．

Fig. 9-10 Rinse execution screen when RINSE2 is selected

9.3.3.3 RINSE3: AUTO1 C&D

Currently executed rinse step is double blinked. By rinse advancement, indicated rinse time

is reduced to show left rinse time.

［ＲＩＮＳＥ３］２１：００＜Ｒｉｎｓｅ＞ＷＴＲ００→ＣＨＭ１５→ＤＷＬ３０→ＰＲＥ３０ＰＲＥＲＩＮＳＥＳＴＡＲＴＴＯＭＯＲＲＯＷ１０：００ＤＩＳＰ．

Fig. 9-11 Rinse execution screen when RINSE3 is selected

9.3.3.4 RINSE4: AUTO2 C&D

Currently executed rinse step is double blinked. By rinse advancement, indicated rinse time

is reduced to show left rinse time.

［ＲＩＮＳＥ４］２１：００＜Ｒｉｎｓｅ＞ＷＴＲ００→ＣＨＭ１５→ＤＷＬ３０→ＰＲＥ３０ＰＲＥＲＩＮＳＥＳＴＡＲＴＴＯＭＯＲＲＯＷ１０：００ＤＩＳＰ．

9-10

Fig. 9-12 Rinse execution screen when RINSE4 is selected

9-11

9.3.4 Rinse end

During rinse end process, rinse result is displayed. Displayed information is defined by

selected mode.

ＮＯＴＥ

z If any SW on operation panel is not pressed for ≧30 minutes during rinse end screen is

displayed, back light is automatically turned off. By pressing the SW, the light is ON.

9.3.4.1 RINSE1: WATER

Rinse time of 00 min is displayed to indicate fluid line function stop. Press [F･5] SW to display settingⅠscreen.

［ＲＩＮＳＥ１］２０：４５＜Ｅｎｄ＞ＷＡＴＥＲＲＩＮＳＥ００ｍｉｎ

ＤＩＳＰ．

Fig. 9-13 Rinse end screen when RINSE1 is selected

9.3.4.2 RINSE2:CHEMICAL

Rinse time of 00 min is displayed to indicate fluid line function stop.

［ＲＩＮＳＥ２］２０：４５＜Ｅｎｄ＞ＣＨＥＭＩＣＡＬＲＩＮＳＥ００ｍｉｎ

ＤＩＳＰ．

Fig. 9-14 Rinse end screen when RINSE2 is selected

9.3.4.3 RINSE3:AUTO1 C&D

Rinse time of 00 min is displayed to indicate fluid line function stop.

［ＲＩＮＳＥ３］１０：４０＜Ｅｎｄ＞ＷＴＲ００→ＣＨＭ００→ＤＷＬ００→ＰＲＥ００ＰＲＥＲＩＮＳＥＳＴＡＲＴＴＯＤＡＹ１０：００ＤＩＳＰ．

Fig. 9-15 Rinse end screen when RINSE3 is selecetd

9.3.4.4 RINSE4:AUTO2 C&D

Rinse time of 00 min is displayed to indicate fluid line function stop.

［ＲＩＮＳＥ４］１０：４０＜Ｅｎｄ＞ＷＴＲ００→ＣＨＭ００→ＤＷＬ００→ＰＲＥ００ＰＲＥＲＩＮＳＥＳＴＡＲＴＴＯＤＡＹ１０：００ＤＩＳＰ．

Fig. 9-16 Rinse end screen when RINSE4 is selected

9-12

9.4 Dialysis screen

9.4.1 Dialysis

Part of dialysis related information is displayed during dialysis wait, preparation, preparation

end, dialysis and recovery processes.

Press [F･1] SW to select single needle dialysis mode. Press [F･2] SW to select sequential HD mode. Press [F･3] SW to select priming mode. Press [F･4] SW to select test mode. Press [F･5] SW to display settingⅠscreen.

［ＤＩＡＬＹＳＩＳ］ＶＰ：１４０ｍｍＨｇＤＰ：１００ｍｍＨｇＣＯＮＤ：１４．０ｍＳ／ｃｍＡＰ：－１００ｍｍＨｇＴＭＰ：４０ｍｍＨｇＴＥＭＰ：３７．０゜ＣＳ．Ｎ．ＳＱＨＤＰＲＩＭＴＥＳＴＤＩＳＰ．

Fig. 9-17 Dialysis screen

INDICATION DESCRIPTION

VP Current venous pressure

AP Current arterial pressure

Displayed only when required option is used

DP Curr ent dialysate pressure

TMP Current TMP

COND Current conductivity

TEMP Current dialysate temperature

ＮＯＴＥ

z Select this screen during dialysis. z Also refer to information found on operation panel. z Information not found in this screen is shown in maintenance mode 1 screen.

9-13

9.4.2 Priming

Priming screen is used to set auto priming conditions and to indicate each step during

priming operation.

Press [F･1] or [F･2] SW to change target priming volume. Press [F･4] SW to release from

priming mode.

Press [F･5] SW to display settingⅠscreen.

［ＰＲＩＭＩＮＧ］ＳＯＬＵＴＩＯＮＶＯＬ．（ｌ）：５．００ＡＣＣＵＭＵＬＡＴＥＤＶＯＬ．（ｌ）：５．００ＲＡＴＩＯ（％）：１００＋－ＥＸＩＴＤＩＳＰ．

Fig. 9-18 Priming screen

INDICATION DESCRIPTION

SOLUTION VOL. Setting of target priming solution volume ACCUMULATED VOL. Display of used priming solution volume RATIO Display of priming progress by ratio

9-14

9.4.3 Test mode

Simple self diagnosis parameters and results are displayed.

Press [F･4] SW to release from test mode. Press [F･5] SW to display settingⅠscreen.

［ＴＥＳＴ］ＢＰ：ＯＫＣＬＶ：ＯＫＢＤ：ＶＰａ：ＶＰｂ：ＶＰ：ＡＰ：ＥＸＩＴＤＩＳＰ．

Fig. 9-19 Test mode screen

INDICATION DESCRIPTION

BP Display of BP test result by OK or NG

CLV Display of clamp test result by OK or NG

BD Display of bubble sensor test result by OK or NG

VPa Display of viscous pump a test result by OK or NG

VPb Display of viscous pump b test result by OK or NG

VP Display of venous pressure sensor test result by OK

or NG

AP Display of arterial pressure sensor test result by OK or

NG when required option is set

ＮＯＴＥ

z The self diagnosis is simple. Accordingly, all required checks can not be performed. z The diagnosis is performed under specified conditions. If the conditions are not satisfied,

NG may be resulted.

9-15

9.5 SettingⅠ screen

Part of required settings is displayed.

Press [F･3] or [F･4] SW to shift blink to desired position and press [F･1]or [F･2] SW to

change setting.

The setting change is enabled at any time required. Press [F･5] SW to display settingⅡscreen.

［ＳＥＴＴＩＮＧ１］１．ＴＥＭＰ（°Ｃ）：３７．０２．ＢＡＲＧＲＡＰＨ：ＤＰ３．Ｓ．ＳＴＰ（ｍｉｎ）：０４．ＢＯＬＵＳ（ｍｌ）：０．０＋－＜＞ＤＩＳＰ．

Fig. 9-20 SettingⅠ screen

INDICATION DESCRIPTION

1.TEMP Setting of dialysate temperature

2.BAR Changeover of DP and AP in DP/AP indicator DP: Dialysate pressure AP: Arterial pressure Blinking only when AP option is set

3.S.STP Setting of syringe stop time (from infusion end to UF end) Displayed only when required option is set.

4.BOLUS Setting of one shot infusion volume Infusate of the set volume is infused automatically by pressing FAST SW of syringe pump. Displayed only when required option is set.

ＮＯＴＥ

z Settings not found in this screen are shown in settingⅡscreen and maintenance mode 2,

5, 6 and 7 screens.

9-16

9.6 SettingⅡ screen

Part of required settings is displayed.

Press [F･3] or [F･4] SW to shift blink to desired position and press [F･1]or [F･2] SW to

change setting.

The setting change is enabled at any time required. Press [F･5] SW to display maintenance mode menu.

［ＳＥＴＴＩＮＧ２］１．ＢＣ（Ｗ＋Ａ＋Ｂ）：１４０２．ＢＣ（Ｗ＋Ａ）：１１０３．ＡＣ（Ｗ＋ＡＣ）：１４０４．ＭＯＤＥ：ＢＣ１＋－＜＞ＤＩＳＰ．

Fig. 9-21 SettingⅡscreen

INDICATION DESCRIPTION

1.BC(W+A+B) Setting of final bicarbonate dialysate at mmol/l unit

2.BC(W+A) Setting of [water + A concentrate] concentration in

bicarbonate dialysate at mmol/l unit

3.AC(W+AC) Setting of final acetate dialysate concentration at

mmol/l unit

4.MODE Selection of dialysis mode corresponding to actually

used concentrate. Information related to the concentrate is shown in maintenance mode 5 screen.

BC1: Bicarbonate dialysis BC2: Bicarbonate dialysis AC: Acetate dialysis

ＮＯＴＥ

z Settings not found in this screen are shown in settingⅡscreen and maintenance mode 2,

5, 6 and 7 screens.

9-17

9.7 Maintenance menu screen

The screen is used to select and register maintenance mode.

Press [F･3] or [F･4] SW to changeover screen and press [F･1] or [F･2] SW to select desired

mode.

Press [F･5] SW to display rinse or dialysis screen. During alarm is actuated, the alarm

screen is displayed.

［ＭＡＩＮＴＥＭＥＮＵ（１／５）］ＭＯＤＥ１：ＤＡＴＡＭＯＤＥ２：ＡＬＡＲＭＳＥＴＴＩＮＧＭＯＤＥ１ＭＯＤＥ２Ｐ．ＵＰＰ．ＤＯＷＮＤＩＳＰ．

Fig. 9-22 Maintenance mode menu screen

9-18

9.8 Alarm screen

The screen is displayed when alarm is actuated.

Press [F･3] or [F･4] SW to find alarm characteristic. Press [F･5] SW to display rinse or dialysis screen.

［ＥＲＲＯＲ］（１０）１．Ｅ２４ＡＩＲＢＵＢＢＬＥ ARE ＤＥＴＥＣＴＥＤ２．Ｅ２６ＳＨＯＲＴＷＡＴＥＲＳＵＰＰＬＹＵＰＤＯＷＮＤＩＳＰ．

Fig. 9-23 Alarm screen

9-19

Chapter 10

ALARM FUNCTIONS AND RESETTING

When any error is detected by the machine, it is alerted by lighting of condition and main lamps with buzzing and the alarm related message is displayed in relevant screen. According to severity of the alarm, corrective functions such as the machine stop is executed automatically by safety system contained in the machine.



ＷＡＲＮＩＮＧ

z If any error is alerted repeatedly, stop the machine to discontinue dialysis immediately

and disconnect patient from the machine. Otherwise, the patient may suffer from serious injury.

10.1 Description of alarms

10.1.1 Functions when error is alerted

If operation is notified of any error incidence, one or more of the following functions

(a) to (j) are executed according to alarm type.

In the case that plural functions are executed, see 10.2.2 “Table of Alarms” to know

the combined functions.

(a) Alarm message display Alarm No. and message are displayed in alarm message screen. One message is

displayed as one line and 2 messages can be displayed simultaneously. If 3 or more of errors are detected, scroll the screen to find other alarm No. and message

by pressing [F･3] or [F･4] SW. (b) Audible alarm Buzzing is caused together with lighting of [MUTE] SW and [RESET] SW lamps on

operation panel. (c) Condition lamp Red lighting (d) Main lamp Red flashing (e) Fluid line stop Fluid flow is disabled by stop of P1 and P2 pumps and heater is turned off. (f) UF stop UF operation is disabled by stop of viscous pump. (UF operation may be continued at

low UFR as “minimum UF” function.) (g) Automatic bypassing

Coupler lines are bypassed to stop dialysate supply to dialyzer.

10-1

(h) Blood or heparin pump stop

Blood or heparin pump is stopped. (i) Clamping

When dialysate pressure related error or bubble in blood line is detected, the line

is clamped temporarily. (j) Dialysate pressure release or air removal from dialysate

When dialysate pressure exceeds preset level, it is alerted and the pressure is

released automatically. When air is detected in dialysate lines during dialyzer

connection, the air is automatically removed.

10.1.2 Procedure for resetting

To return the machine functions to normal after removal of error causes, follow the

below procedures. See 10.2.2 “Table of Alarms” to find the error causes and the like. ① Press [MUTE] SW once.

• Audible alarm is muted.

• [MUTE] SW lamp is OFF.

② Remove error causes. ③ Press [RESET] SW once.

• [RESET] SW lamp is OFF.

• The machine functions are returned to normal.

10.1.3 Actions to respond to alarm (flow)

Error incidence

↓

Detection of error and execution of machine functions responding to the error

↓

Buzzing OFF by operator

↓

Removal of error causes by operator

↓

Resetting by operator

10-2

10.2 Table of alarms

10.2.1 Meanings of terms contained in “Table of alarms”

(1) Alarm No.

Alarm No. indicated in alarm screen

(2) Alarm name

Alarm name indicated in alarm screen

(3) Detection condition

Condition to be detected. Unless otherwise specified, it is recognized as alarm when

the condition continues for specified time (1 to 5 seconds). The time is defined by alarm type.

(4) Detection process

Process in which error is detected

(5) Audible alarm

When buzzing is caused after error detection, "○" is marked. If bussing is muted

after specified number of runs automatically, the number is indicated. If the alarm condition is specified by any detection process, the condition and the process aligned horizontally are marked with "・".

(6) Fluid line function

Fluid line function after error detection. If the function is specified by any detection

process, the function and the process aligned horizontally are marked with "・". If the function is not changed after the detection, "－" is marked.

(7) BP/SP stop

When blood or syringe pump is stopped by error detection, "○" is marked. If the

pump is stopped for specified time, the time is indicated. When blood pump only is stopped , "BP stop" and when syringe pump only is stooped, "SP stop" is indicated.

(8) CLV close

When blood line is clamped b y error detection, "○" is marked. If the line is clamped

for specified time, the time is indicated and if not clamped, "－" is marked.

(9) Alarm release

When alarm release is enabled, "○" is marked and when disabled, "－" is marked. In

the former case, the release is possible in maintenance mode 3 and part of alarms can be released by erasing the set alarm value.

(10) Resetting and note Alarm resetting method and note. Almost all alarms can be reset by pressing [RESET] SW.

10-3

Part of alarms may be reset by release of the alarm from detection condition.

10-4

10.2.2 Table of alarms

Alarm

No. E01 RECOVER FROM

E02 T1 TEMPERATURE

E03 T2 TEMPERATURE

E04 T3 TEMPERATURE

E05 DIALYSATE

Alarm name

EMERGENCY STOP

SENSOR ERROR

TEMPERATURE MAX ALARM

Return to normal after power failure caused during sequence execution

T1 temperature exceeding measurable temperature

T2 temperature exceeding measurable temperature

T3 temperature exceeding measurable temperature

Dialysate temperature (T3) of ≧ set upper alarm limit

Detection condition

Detection

process

•Rinse

•Preparation

•Preparation end

•Dialysis

•Recovery

•Rinse wait

•Rinse

•Rinse end

•Air purge

•Dialysis wait

•Preparation

•Preparation end

•Dialysis

•Recovery

•Rinse wait

•Rinse

•Rinse end

•Air purge

•Dialysis wait

•Preparation

•Preparation end

•Dialysis

•Recovery

•Rinse wait

•Rinse

•Rinse end

•Air purge

•Dialysis wait

•Preparation

•Preparation end

•Dialysis

•Recovery

•Preparation

•Preparation end

•Dialysis

•Recovery

Audible alarm

○(3 times)

•○(7 times)

•Same as above

•○(Continuous)

•Same as above

•○(7 times)

•Same as above

•○(Continuous)

•Same as above

•○(7 times)

•Same as above

•○(Continuous)

•Same as above

○(Continuous)

Fluid line

function

Execution of sequence before error detection

•Continuance

•Same as above

•Fluid line stop

•Same as above

•Continuance

•Same as above

•Fluid line stop

•Same as above

•Continuance

•Same as above

•Fluid line stop

•Same as above

Auto bypass Heater OFF

BP SP

stop

― ― ―

― ― ○

CLV

close

Alarm

release

Resetting and note

Automatic return to normal Becoming error free of set upper and lower VP/ AP/ DP alarm limits by alarm actuation

Return to normal by pressing [RESET] SW

Return to normal by pressing [RESET] SW During rinse process, upper value of measurable range could not be detected.

[Return to normal by pressing [RESET] SW

Return to normal by pressing [RESET] SW Auto reset after release from detection condition for 10 sec

10-4

Alarm

No. E06 DIALYSATE

E07 DIALYSATE PRESSURE

E08 DIALYSATE PRESSURE

E09 DIALYSATE PRESSURE

E10 DIALYSATE PRESSURE

E11 VENOUS PRESSURE

Alarm name

TEMPERATURE MIN ALARM

MAX LIMIT

MIN LIMIT

MAX ALARM

MIN ALARM

MAX LIMIT

Detection condition

Dialysate temperature (T3) of ≦set lower alarm limit

Dialysate pressure of ≧+400mmHg

Dialysate pressure of ≦-400mmHg

Dialysate pressure of ≧ set upper alarm limit

Dialysate pressure of ≦ set lower alarm limit

Venous pressure of ≧+400mmHg

Detection

process

Dialysis

•Rinse wait

•Rinse

•Rinse end

•Air purge

•Dialysis wait

•Preparation

•Preparation end

•Dialysis

•Recovery

•Rinse wait

•Rinse

•Rinse end

•Air purge

•Dialysis wait

•Preparation

•Preparation end

•Dialysis

•Recovery

•Dialysis wait

•Preparation

•Preparation end

•Dialysis

•Recovery

•Dialysis wait

•Preparation

•Preparation end

•Dialysis

•Recovery

•Rinse wait

•Rinse

•Rinse end

•Air purge

•Dialysis wait

•Preparation

•Preparation end

•Dialysis

•Recovery

Audible alarm

○(3 times)

•○(7 times)

•Same as above

•○(Continuous)

•Same as above

•○(7 times)

•Same as above

•○(Continuous)

•Same as above

○(Continuous)

•○(7 times)

•Same as above

•○(Continuous)

•Same as above

Fluid line

function

Auto bypass

UF stop V4,V10 ON for 2 sec

UF stop

BP SP

stop

― ― ○

2 sec 2 sec

○ ― ○

CLV

close

release

Alarm

○

Resetting and note

Return to normal by pressing [RESET] SW Auto reset after release from detection condition for 10 sec Auto return of BP/SP/CLV to normal Return of UF stop to normal by pressing [RESET] SW

Auto return of BP/SP/CLV to normal Return of UF stop to normal by pressing [RESET] SW

Auto return of BP/SP/CLV to normal Return of UF stop to normal by pressing [RESET] SW Becoming error free of set upper and lower VP alarm limits by alarm actuation

Return to normal by pressing [RESET] SW

10-5

Alarm

No. E12 VENOUS PRESSURE MIN

E13 VENOUS PRESSURE

E14 VENOUS PRESSURE MIN

E15 ARTERIAL PRESSURE

E16 ARTERIAL PRESSURE

Alarm name

LIMIT

MAX ALARM

ALARM

MAX LIMIT

MIN LIMIT

Detection condition

Venous pressure of ≦-400mmHg

Venous pressure of ≧set upper alarm limit

Venous pressure of ≦set lower alarm limit

Arterial pressure of ≦+400mmHg

Arterial pressure of ≦-400mmHg

Detection

process

•Rinse wait

•Rinse

•Rinse end

•Air purge

•Dialysis wait

•Preparation

•Preparation end

•Dialysis

•Recovery

•Dialysis wait

•Preparation

•Preparation end

•Dialysis

•Recovery

•Dialysis wait

•Preparation

•Preparation end

•Dialysis

•Recovery

•Rinse wait

•Rinse

•Rinse end

•Air purge

•Dialysis wait

•Preparation

•Preparation end

•Dialysis

•Recovery

•Rinse wait

•Rinse

•Rinse 終了

•Air purge

•Dialysis wait

•Preparation

•Preparation end

•Dialysis

•Recovery

Audible alarm

•○(7 times)

•Same as above

•○(Continuous)

•Same as above

○(Continuous)

•○(７times)

•Same as above

•○(Continuous)

•Same as above

•○(７times)

•Same as above

•○(Continuous)

•Same as above

Fluid line

function

UF stop

BP SP

stop

○ ― ○

CLV

close

Alarm

release

Resetting and note

Return to normal by pressing [RESET] SW

Return to normal by pressing [RESET] SW Becoming error free of set upper and lower DP alarm limits by alarm actuation

Return to normal by pressing [RESET] SW Becoming error free of set upper and lower VP alarm limits by alarm actuation

Return to normal by pressing [RESET] SW

[Return to normal by pressing [RESET] SW

10-6

Alarm

No. E17 ARTERIAL PRESSURE

E18 ARTERIAL PRESSURE

E19 TMP ALARM

E20 DIALYSATE

E21 DIALYSATE

E22 BLOOD LEAK SENSOR

E23 BLOOD LEAK ALARM

E24 AIR BUBBLES ARE

Alarm name

MAX ALARM

MIN ALARM

CONDUCTIVITY MAX ALARM

CONDUCTIVITY MIN ALARM

ERROR

DETECTED

Detection condition

Arterial pressure of ≧set upper alarm limit

Arterial pressure of ≦set lower alarm limit

[VP-DP] of ≧ set alarm limit Dialysate conductivity of ≧set upper alarm limit

Dialysate conductivity of ≦set lower alarm limit

•Detection of absolute blood leak REAL value of ≧ 201 in preparation or preparation end process

•Detection of absolute blood leak REAL value of ≦ 201 in dialysis or recovery process

•Signaling of rinse alarm Blood leak value of ≧set alarm limit Bubble detection during

ON of BUBBLE [ON/OFF] SW

Detection

process

•Dialysis wait

•Preparation

•Preparation end

•Dialysis

•Recovery

•Dialysis wait

•Preparation

•Preparation end

•Dialysis

•Recovery

•Dialysis

•Recovery

Dialysis

•Preparation

•Preparation end

•Dialysis

•Recovery

Dialysis

•Rinse wait

•Rinse

•Rinse end

•Air purge

•Dialysis wait

•Preparation

•Preparation end

•Dialysis

•Recovery

Audible alarm

○(Continuous)

•○(7 times)

•Same as above

•○(Continuous)

•Same as above

Fluid line

function

UF stop

Auto bypass

Fluid line stop

UF stop Auto bypass

UF stop

BP SP

stop

○ ― ○

○ ○ ○

― ― ―

― ― ○

○ ― ○

○

SW-OF

F

CLV

close

○ ○

Alarm

release

Resetting and note

Return to normal by pressing [RESET] SW Becoming error free of set upper and lower DP alarm limits by alarm actuation

Return to normal by pressing [RESET] SW

Return to normal by pressing [RESET] SW Auto reset after release from detection condition for 10 sec Return to normal by pressing [RESET] SW Auto reset after release from detection condition for 10 sec Return to normal by pressing [RESET] SW

Return to normal by pressing [RESET] SW

Return of UF stop/CLV to normal by pressing [RESET] SW Return of BP/SP to normal by SW-ON Error detection only when BUBBLE [ON/OFF] SW is ON

10-7

Alarm

No. E25 HEATER OVER HEAT

E26 SHORT WATER SUPPLY Detection of no water

E27 SHORT DIALYSATE

E28 DIALYSATE FLOW STOP

E29 SN SWITCH TIME ALARM No arrival at changeover

E30 BLOOD PUMP ERROR

E31 BLOOD PUMP STOP

ALARM

FLOW

ERROR

Alarm name

Functioning of "LS1" placed at heater outside wall

supply pressure by pressure SW "PS"

No functioning of "FS" for 85 sec after chamber change-over

•Functioning of “FS” within 20 sec after chamber change-over

•Functioning of “FS” for 170 sec during dialysis process other than SQHD

pressure after set SN alarm time

• Overload

• Abnormal rotating

direction

• Abnormal rotating speed

• Opening of blood pump

over

• OFF of blood pump [ON/OFF] SW

• 0 setting of blood pump flow rate setting volume

Detection condition

Detection

process

•Preparation

•Preparation end

•Dialysis

•Recovery

•Rinse

•Preparation

•Preparation end

•Dialysis

•Recovery

•Preparation

•Preparation end

•Dialysis

•Recovery

•Rinse(water

rinse)

•Preparation

•Preparation end

•Dialysis

•Recovery

Dialysis

•Rinse wait

•Rinse

•Rinse end

•Air purge

•Dialysis wait

•Preparation

•Preparation end

•Dialysis

•Recovery

Dialysis

Audible alarm

○(Continuous)

•○(７times)

•○(Continuous)

•Same as above

○(Continuous) ― ― ― ―

•○(７times)

•○(Continuous)

•Same as above

○(Continuous)

•○(７times)

•Same as above

•○(Continuous)

•Same as above

○(Continuous)

Fluid line

function

Heater OFF

Fluid line stop

UF stop

― ○

UF stop SPstop

BP SP

stop

― ― ―

― ― ○

― ― ―

○ ○ ○

SW-OF

F

CLV

close

― ―

Alarm

release

Resetting and note

Return to normal by pressing [RESET] SW

[Return to normal by pressing [RESET] SW

[Return to normal by pressing [RESET] SW Error detection only when SN SW is ON

Return to normal by pressing [RESET] SW Return to normal by BP/SPSW-ON

Return to normal by pressing [RESET] SW Auto reset by release from detection condition

10-8

Alarm

No. E32 CLV POSITION ERROR Abnormal clamp position

E33 VISCOUS PUMP DRIVING

E34 VISCOUS PUMP DRIVING

E35 VP DRAWING VOLUME

E36 VPa CLOSED CIRCUIT

E37 VPa CLOSED CIRCUIT

E38 VPb CLOSED CIRCUIT

E39 VPb CLOSED CIRCUIT

Alarm name

ERROR(VPa)

ERROR(VPb)

IS AT MAX LIM.

LEAK ERROR

Error of viscous pump a

Error of viscous pump b

Viscous pump operation out of allowable range

Insufficient negative pressure in A chamber No arrival at set pressure within set time Fluctuated negative pressure in A chamber Pressure fluctuation out of set range during set time Insufficient negative pressure in B chamber No arrival at set pressure within set time Fluctuated negative pressure in B chamber Pressure fluctuation out of set range during set time

Detection condition

Detection

process

•Rinse wait

•Rinse

•Rinse end

•Air purge

•Dialysis wait

•Preparation

•Preparation end

•Dialysis

•Recovery

•Rinse

•Preparation

•Preparation end

•Dialysis

•Recovery

•Rinse

•Preparation

•Preparation end

•Dialysis

•Recovery

•Rinse

•Preparation

•Preparation end

•Dialysis

•Recovery

Rinse(water rinse)

Audible alarm

•○(７times)

•Same as above

•○(Continuous)

•Same as above

•○(７times)

•○(Continuous)

•Same as above

•○(７times)

•○(Continuous)

•Same as above

•○(７times)

•○(Continuous)

•Same as above

○(７times) ― ― ― ○

Fluid line

function

― ○

Fluid line stop

BP SP

stop

SW-OF

F

― ― ○

CLV

close

― ―

Alarm

release

Resetting and note

Return to normal by pressing [RESET] SW Return to normal by BP/SPSW-ON

Return to normal by pressing [RESET] SW

[Return to normal by pressing [RESET] SW

Return to normal by pressing [RESET] SW

Return to normal by pressing [RESET] SW Possible alarm release in maintenance mode 2

10-9

Alarm

No. E40 VPa CLOSED CIRCUIT

E41 VPa CLOSED CIRCUIT

E42 VPb CLOSED CIRCUIT

E43 VPb CLOSED CIRCUIT

E44 AIR ELIMINATION TANK

E45 BLOWN-OUT FUSE

E46 WATCH-DOG ERROR System resetting after

Alarm name

LEAK ERROR

ERROR

DETECTION

Insufficient positive pressure in A chamber No arrival at set pressure within set time Fluctuated positive pressure in A chamber Pressure fluctuation out of set range during set time Insufficient positive pressure in B chamber No arrival at set pressure within set time Fluctuated positive pressure in B chamber Pressure fluctuation out of set range during set time Functioning of "FSW" of air elimination tank for ≧ 15 sec in dialysis process or for ≧ 30 sec in any process other than dialysis Blown out of pump fuse

system error detection by watch dog

Detection condition

Detection

process

Rinse(water rinse)

•Rinse

•Preparation

•Preparation end

•Dialysis

•Recovery

•Rinse wait

•Rinse

•Rinse end

•Air purge

•Dialysis wait

•Preparation

•Preparation end

•Dialysis

•Recovery

•Rinse wait

•Rinse

•Rinse end

•Air purge

•Dialysis wait

•Preparation

•Preparation end

•Dialysis

•Recovery

Audible alarm

○(７times) ― ― ― ○

•○(7 times)

•○(Continuous)

•Same as above

•○(７times)

•Same as above

•○(Continuous)

•Same as above

•○(７times)

•Same as above

•○(Continuous)

•Same as above

Fluid line

function

•―

•Same as above

•Fluid line stop

•―

Fluid line stop

― ― ― ―

BP SP

stop

― ― ○

― ― ―

CLV

close

Alarm

release

Resetting and note

Return to normal by pressing [RESET] SW Possible alarm release in maintenance mode 2

Return to normal by pressing [RESET] SW

Return to normal by pressing [RESET] SW RAM initialization after error detection

10-10

Alarm

No. E47 RAM ERROR RAM error

E48 EEPROM ERROR EEPROM error

E49 EPROM ERROR EPROM error

E50 RAM INITIALIZE RAM initialization

Alarm name

Detection condition

Detection

process

•Rinse wait

•Rinse

•Rinse end

•Air purge

•Dialysis wait

•Preparation

•Preparation end

•Dialysis

•Recovery

•Rinse wait

•Rinse

•Rinse end

•Air purge

•Dialysis wait

•Preparation

•Preparation end

•Dialysis

•Recovery

•Rinse wait

•Rinse

•Rinse end

•Air purge

•Dialysis wait

•Preparation

•Preparation end

•Dialysis

•Recovery

•Rinse wait

•Rinse

•Rinse end

•Air purge

•Dialysis wait

•Preparation

•Preparation end

•Dialysis

•Recovery

Audible alarm

•○(７times)

•Same as above

•○(Continuous)

•Same as above

•○(７times)

•Same as above

•○(Continuous)

•Same as above

•○(７times)

•Same as above

•○(Continuous)

•Same as above

•○(７times)

•Same as above

•○(Continuous)

•Same as above

Fluid line

function

― ― ― ―

BP SP

stop

CLV

close

Alarm

release

Resetting and note

Return to normal by pressing [RESET] SW Error detection only when power SW is ON or power failure is corrected RAM initialization after error detection

Return to normal by pressing [RESET] SW Error detection only when power SW is ON or power failure is corrected

Return to normal by pressing [RESET] SW Error detection only when power SW is ON or power failure is corrected RAM initialization after error detection

Return to normal by pressing [RESET] SW Error detection only when power SW is ON or power failure is corrected Auto shift to dialysis wait process after error detection

10-11

Alarm

No. E51 EEPROM INITIALIZE EEPROM initialization

E52 SWITCH ERROR ON of any SW on

E53 I/O PORT ERROR Error of I/O port on board

E54 CONNECTION ERROR

Alarm name

SBY0151-SBY0156

operation panel for 30 sec continuously at power SW ON

Disconnection of harness used to connect main board to operation board

Detection condition

Detection

process

•Rinse wait

•Rinse

•Rinse end

•Air purge

•Dialysis wait

•Preparation

•Preparation end

•Dialysis

•Recovery

•Rinse wait

•Rinse

•Rinse end

•Air purge

•Dialysis wait

•Preparation

•Preparation end

•Dialysis

•Recovery

•Rinse wait

•Rinse

•Rinse end

•Air purge

•Dialysis wait

•Preparation

•Preparation end

•Dialysis

•Recovery

•Rinse wait

•Rinse

•Rinse end

•Air purge

•Dialysis wait

•Preparation

•Preparation end

•Dialysis

•Recovery

Audible alarm

•○(７times)

•Same as above

•○(Continuous)

•Same as above

•○(７times)

•Same as above

•○(Continuous)

•Same as above

•○(７times)

•Same as above

•○(Continuous)

•Same as above

•○(７times)

•Same as above

•○(Continuous)

•Same as above

Fluid line

function

― ― ― ―

Fluid line stop

BP SP

stop

○ ― ―

CLV

close

Alarm

release

Resetting and note

Return to normal by pressing [RESET] SW Error detection only when power SW is ON or power failure is corrected Auto shift to dialysis wait process after error detection

Return to normal by pressing [RESET] SW

Return to normal by power SW ON Disabled all functions of the machine and components on operation panel after error detection

10-12

Alarm

No. E55 BP BATTERY ERROR BP backup battery voltage

E56 COUPLER SW ON

E57 COUPLER SW ON

E58 COUPLER SW OFF

E59 UF MAX ALARM BP flow rate/UFR relation

E60 SYRINGE INFUSION

E61 COMPLETION OF

E62 PERFORMED PRIMING Priming completion with

E63 PREFORMED TARGET

Alarm name

ALARM ( DIALYSIS)

ALARM ( PREP.)

ALARM

COMPLETION

SYRINGE.P INFUSION

UF.

of ≦8.5V

"LS2" ON Dialysis

Pressing [UF DIALYSE] SW during "LS2" is ON

"LS2" OFF Rinse

of ≧set upper UFR alarm limit Syringe pump SW ON; and detection of the pump over-load signal "LS3"

Arrival at preset syringe operation stop time

preset solution volume

Achievement of target UF volume

Detection condition

Detection

process

•Rinse wait

•Rinse

•Rinse end

•Air purge

•Dialysis wait

•Preparation

•Preparation end

•Dialysis

•Recovery

•Preparation end

•Recovery

Dialysis

•Rinse wait

•Rinse

•Rinse end

•Air purge

•Dialysis wait

•Preparation

•Preparation end

•Dialysis

•Recovery

Dialysis

Priming

Dialysis

Audible alarm

•○(７times)

•Same as above

•○(Continuous)

•Same as above

○(Continuous)

○(3 times) ― ― ― ―

○(3 times)

○(Continuous)

•○(７times)

•Same as above

•○(Continuous)

•Same as above

○(3 times) ―

○(Continuous)

Fluid line

function

― ― ― ○

Fluid line stop

UF stop

―

UF stop

BP SP

stop

― ― ―

SP stop

BP stop

SW-OF

F

― ― ―

CLV

close

― ―

○ ―

Alarm

release

Resetting and note

Return to normal by pressing [RESET] SW Possible alarm release in maintenance mode 7

Return to normal by pressing [RESET] SW

Return to normal by pressing [RESET] SW Auto reset by release from detection condition Return to normal by pressing [RESET] SW Auto reset by release from detection condition Return to normal by pressing [RESET] SW Auto reset by release from detection condition

Return to normal by pressing [RESET] SW Auto reset by release from detection condition Error detection when SP SW is ON

Return to normal by pressing [RESET] SW Auto reset by release from detection condition Return to normal by pressing [RESET] SW Auto reset by release from detection condition Return to normal by pressing [RESET] SW Auto reset by release from detection condition Becoming error free of set upper and lower VP/DP alarm limits by alarm actuation

10-13

Alarm

No. E64 NO WATER RINSING Shift to dialysis wait

E65 PREPARE DIALYSATE

E66 CONC CONNECTOR TO

E67 RESET SW No press of [RESET] SW

E68 UF DIALYSE SW No press of [UF DI ALYSE]

E69 BYPASS SW No release from manual

Alarm name

CONC.

RINSING PORT.

process without executing water rinse for specified time after disinfection/rinse, acid rinse, hot water rinse or hot chemical disinfectant rinse. Detection of no pressure rise in A or B concentrate line by "PS" and detection of no connection of the line to the machine Detection of pressure rise in A or B concentrate line by "PS" and detection of no connection of the line to rinse port

for set time after alarm actuation

SW for set time

ON of [BYPASS] SW within set time

Detection condition

Detection

process

Dialysis wait

Preparation

Rinse Preparation

•Dialysis wait

•Preparation

•Preparation end

•Dialysis

•Recovery

Preparation end

Dialysis

Audible alarm

○(3 times) ― ― ― ―

○(Continuous)

○ (3 times) ○ (continuour)

○(Continuous) ― ― ― ○

○(3 times) ― ― ― ○

Fluid line

function

Fluid line stop

BP SP

stop

― ― ―

CLV

close

Alarm

release

Resetting and note

Return to normal by pressing [RESET] SW Return to normal by water rinsing for specified time

Return to normal by pressing [RESET] SW

Return to normal by pressing [RESET] SW Possible alarm release in maintenance mode 2

Return to normal by pressing [RESET] SW Possible alarm release in maintenance mode 2 Return to normal by pressing [RESET] SW Possible alarm release in maintenance mode 2

10-14

Chapter 11

CLEANING AND DISINFECTION

After use of the machine, clean and disinfect it for maintaining its high performance. Refer to the optional manual of the optional hot water rinse and hot chemical disinfectant

rinse function.

11.1 Cleaning and disinfection of machine outside

11.1.1 Machine enclosure

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 paint damage.

CAUTION

• Clean and disinfect venous and arterial pressure inlet ports carefully to prevent cross infection among patients.

• Take care that any fluid is not introduced into venous and arterial pressure inlet ports to

prevent their pressure sensor damage.

11.1.2 Dialysate concentrate connectors and rinse ports

After long term use of dialysate concentrate connectors and rinse ports, solutes in the concentrates may isolate 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.

CAUTION

• DO NOT use disinfectant such as dilute NaClO solution because NaClO generates chlorine

by spontaneous decomposition. Chlorine is not only harmful to human body, but also damages electric components, resulting the machine failure.

11.2 Cleaning and disinfection of fluid lines

(a) Remove dirt from the fluid line outside using cloth wetted with water. (b) It the outside is contaminated with any concentrate, remove it by wiping to prevent

rust formation.

NOTE

z Clean and disinfect the fluid line outside after disconnecting power plug from receptacle.

11-1

DANGER

z Cleaning of electric circuits in the machine is very dangerous and hazardous. The circuit

covers should be removed by authorized personnel only.

11.3 Disinfection of fluid line inside

Fluid line inside can be disinfected by executing disinfection/rinsing operation after

selecting rinse mode.

WARNING

z Disinfect dialysate line inside after each dialysis termination. If not disinfected for a long

time, the machine inside may be contaminated with proliferated microorganisms, which may be introduced into patient body, threatening his/her life.

11.3.1 Concentration of disinfectant concentrate Use of sodium hypochlorite solution is recommended to disinfect the machine.

Usable concentration of sodium hypochlorite concentrate is ≦6%. Check the concentration indicated on its container and dilute to ≦6% if required.

CAUTION

z If Na hypochlorite concentrate of concentration exceeding 6% is used, fluid line materials

may be damaged.

z If the concentrate is required to be diluted, use haemodialyis-quality water specified by

AAMI.

z DO NOT connect the concentrate to the machine for a long time. The concentration may be

reduced by evaporation of Na hypochlorite, causing insufficient disinfection performance.

11.3.2 Diluted disinfectant concentration and disinfection time

After checking that Na hypochlorite concentrate is connected to the machine, set the

diluted concentration to 1000ppm and disinfection time to 50min≦Disinfection time ≦60min or diluted concentration to 300ppm and disinfection time to 6 hours≦ Disinfection time≦24 hours in maintenance mode 7.

WARNING

z If the diluted concentration is lower than 1000ppm and disinfection time is shorter than 50

minutes, sufficient disinfection performance can not be obtained. Therefore, fluid line inside may be contaminated with proliferated microorganisms, which may be introduced into patient body, threatening his/her life.

11-2

11.3.3 Method to set dilution rate of disinfectant concentrate

It is necessary to release protect for setting based on the procedure specified in “Service

Manual” to set dilution rate of disinfectant concentrate.

(1) Press [F･5] SW to display maintenance mode menu screen. (2) Press [F･3] or [F･4] SW to display "MODE7" and press [F･1] SW.

［ＭＡＩＮＴＥＭＥＮＵ（４／５）］ＭＯＤＥ７：ＳＹＳＴＥＭＭＯＤＥ８：ＳＥＲＶＩＣＥＦＲＥＱＵＥＮＣＹＭＯＤＥ７ＭＯＤＥ８Ｐ．ＵＰＰ．ＤＯＷＮＤＩＳＰ．

Ｆ・１Ｆ・２Ｆ・３Ｆ・４Ｆ・５

(3) Press [F･3] or [F･4] SW to blink "4.DISINFECTION RATIO". (4) Press [F･1] or [F･2] SW to set dilution rate of disinfectant concentrate.

［ＭＡＩＮＴＥ７］４．ＤＩＳＩＮＦＥＣＴＩＯＮＲＡＴＩＯ：１／３００５．ＡＣＩＤＲＡＴＩＯ：１／３０＋－ＵＰＤＯＷＮＭＥＮＵ

Ｆ・１Ｆ・２Ｆ・３Ｆ・４Ｆ・５

(5) Press [F･5] SW to return to maintenance menu screen.

11.3.4 Check of residual disinfectant



ＷＡＲＮＩＮＧ

z If disinfectant remains in the machine even though the amount is small, patient life may

be threatened.

z Execute water rinse for 30 minute or more after disinfection. The time, however, is

changed according to diluted disinfectant concentration and dialysate flow rate. It is recommended to check residual disinfectant amount using test paper or reagent.

11-3

11.4 Removal of calcium deposit from fluid line inside

Execute acid rinse in rinse mode to remove calcium deposit from fluid line inside.



ＷＡＲＮＩＮＧ

z When bicarbonate dialysate is used, calcium salt is deposited in fluid line inside. The

deposition may cause microbial proliferation and malfunction of the machine components. Remove the deposit once or more weekly.

11.4.1 Concentration of acetic acid concentrate

It is recommended to use acetic acid to remove the deposit. Usable concentration of acetic acid concentrate is ≦50%. Check the concentration indicated on the container and dilute to ≦50% if necessary.



ＣＡＵＴＩＯＮ

z If acetic acid concentrate of concentration exceeding 50% is used, fluid line materials

may be damaged.

z If the concentrate is required to be diluted, use haemodialysis-quality water specified by

AAMI.

z DO not connect the concentrate to the machine for a long time. The concentration may be

reduced by evaporation of acetic acid, causing insufficient calcium deposit removing performance.

11.4.2 Diluted disinfectant concentration and disinfection time

After checking that acetic acid concentrate is connected to the machine, set the diluted

concentration to 1-2% and acid rinse time to ≧30 minutes in maintenance mode

7.

11.4.2 Concentration of acetic acid to be diluted



ＷＡＲＮＩＮＧ

z If diluted acetic acid concentration is lower than 1% and acid rinse time is shorter than 30

minutes, microbial proliferation and malfunction of the machine components may be caused.

11-4

11.4.3 Method to set dilution rate of acetic acid concentrate

It is necessary to release protect for setting based on the procedure specified in “Service

Manual” to set dilution rate of acetic acid concentrate.

(1) Press [F･5] SW to display maintenance menu screen. (2) Press [F･3] or [F･4] SW to display "MODE7" and press [F･1] SW.

［ＭＡＩＮＴＥＭＥＮＵ（４／５）］ＭＯＤＥ７：ＳＹＳＴＥＭＭＯＤＥ８：ＳＥＲＶＩＣＥＦＲＥＱＵＥＮＣＹＭＯＤＥ７ＭＯＤＥ８Ｐ．ＵＰＰ．ＤＯＷＮＤＩＳＰ．

Ｆ・１

Ｆ・２

Ｆ・３

Ｆ・４

Ｆ・５

(3) Press [F･3] or [F･4] SW to blink "5.ACID RATIO". (4) Press [F･1] or [F･2] SW to set dilution rate of acetic acid concentrate.

［ＭＡＩＮＴＥ７］５．ＡＣＩＤＲＡＴＩＯ：１／３０６．ＨＯＴＤＩＳＩＮＦＥＣＴＩＯＮＲＡＴＩＯ：１／２６＋－ＵＰＤＯＷＮＭＥＮＵ

Ｆ・１

Ｆ・２

Ｆ・３

Ｆ・４

Ｆ・５

(5) Press [F･5] SW to return to maintenance menu screen.

11.4.4 Check of residual acetic acid



ＷＡＲＮＩＮＧ

z If acetic acid remains in the machine even though the amount is small, patient life may be

threatened.

z Execute water rinse for 30 minute or more after acid rinse. Th e time, however, is changed

according to diluted acetic acid concentration and dialysate flow rate. It is recommended to check residual acetic acid amount using test paper or reagent.

11-5

Chapter 12

PROCESS FLOW

12.1 Process flow

Rinsing operation is classified into 3 processes: “rinse wait”, “rinse” and “rinse end”. Dialysis operation is classified into 5 processes: “dialysis wait”, “preparation”, “preparation

end”, “dialysis” and “recovery”.

Additionally, “air purge” process to be executed at the machine installation is found in

maintenance mode 9.

The process flow is as follows:

[DIALYSIS]SW_OFF

[FUNCTION]SW_ON

透析待機工程

Dialysis wait

[DIALYSIS]SW_ON

洗

浄待機工程

Rinse wait

エア抜き工程

Air purge

準備工程

Preparation Rinse

自動

Preparation

準備完了工程

end

[UF DIALYSE]SW_ON

Dialysis

透析工程

[PREP.]SW_ON [UF DIALYSE]SW_ON

R y ecover

回収工程

[RINSE]SW_ON[PRIP.]SW_ON

洗浄工程

洗浄終了

洗浄終了工程

Rinse end

Fig. 12-1 Process flow

12-1

12.2 Description of process flow

By turning on power SW, rise screen is displayed followed by shifting to process executed

before turning off the SW previously. Then, each process is followed by relevant SW operation.

12.2.1 Rinse wait process

By turning off [DIALYSIS] SW, “rinse wait” process is followed and fluid line function is disabled. In the process, it is possible to select and set rinse mode as desired in rinse menu screen; and to activate “air purge” process.

12.2.2 Rinse process

When “rinse” mode is selected in “rinse wait” process, the process is shifted to “rinse” process by pressing [RINSE] SW.

In the process, “water rinse”, “disinfection/rinse”, “acid rinse”, “dwelling” or “prerinse” mode can be selected and executed as desired.

Addition of hot rinse option provide Hot water rinse and Hot chemical disinfectant rinse.

12.2.2.1 Water rinse mode

In the mode, each of fluid lines is water rinsed and leak from closed circuit is checked.

ＮＯＴＥ

z To check leak from closed circuit, positive pressure is applied to the circuit by operating

viscous pump for finding whether fluid is leaked from the circuit. If the leak is detected, “E36～E43 VC CLOSED CIRCUIT LEAK ERROR" is displayed to alert.

12.2.2.2 Disinfection/rinse mode

In the mode, each of fluid lines is disinfected and rinsed. After rinsing for specified time, disinfectant concentrate supply line is back flushed.

12.2.2.3 Acid rinse mode

In the mode, each of fluid lines is acid rinsed. After rinsing for specified time, acetic acid concentrate supply line is back flushed.

12.2.2.4 Dwelling mode

In the mode, fluid lime function is disabled. The mode is used to disinfect each of fluid lines sufficiently by dwelling disinfectant in it for specified time.

12.2.2.5 Prerinse mode

In the mode, fluid line function is disabled until arrival at preset prerinse start day and time. By arrival at the day and time, water rinse is started automatically. It is possible to execute “dwelling” mode before starting “prerinse” mode when “dwelling” mode is selected after “disinfection/rinse” mode is completed.

12-2

12.2.3 Rinse end process

When “rinse” process is completed, “rinse end” process is followed and fluid line function is disabled. To repeat rinsing, turn off [DIALYSIS] SW to allow start of “rinse wait” process.

12.2.4 Dialysis wait process

When [DIALYSIS] SW is turned on, “dialysis wait” process is followed and fluid line function is disabled.

12.2.5 Preparation process

In “dialysis wait” process, when [PREP.] SW is turned on, “preparation” process is followed and dialysate preparation is started. During the preparation, <Standby> is displayed in screen. The process is designed to execute fluid replacement in fluid lines.

12.2.6 Preparation end process

In “preparation” process, when the following conditions①to ③are satisfied, “preparation end” process is followed. After shifting to the process, it is possible to shift to “dialysis” process by pressing [UF DIALYSE] SW.

① Dialysate conductivity within allowable alarm limits ② Dialysate temperature within allowable alarm limits ③ Execution of 4 rounds of chamber change after start of dialysate preparation

Even in “preparation end” process, if any of the above conditions is not satisfied, dialysate flow is auto-bypassed or any alarm is actuated, shift to “dialysis” process is disabled unless the condition is satisfied; or the bypassing or the alarm is corrected.

12.2.7 Dialysis process

In “preparation end” or “recovery” process, when [UF DIALYSE] SW is turned on, “dialysis” process is followed. In the process, UF is executed.

12.2.8 Recovery process

In “dialysis” process, when [PREP.] SW is turned on, “recovery” process is followed. In the process, blood is recovered.

12.2.9 Air purge process

In “rinse wait” process, when maintenance mode 9 screen is displayed and [F･1] SW is pressed, “air purge” process is followed. In the process, air is removed from fluid lines. The process is executed at the machine installation and the like.

12-3

Chapter 13

OPERATION OF MACHINE

13.1 Check and action before turning on power breaker

Before starting daily operation of the machine, check the following items specified in the below Table and correct non-conformance immediately if detected.



ＷＡＲＮＩＮＧ

z If non-conformance can not be corrected, DO NOT operate the machine.

No. Item to be checked

Paint out □

1 Installation conditions

・ Ambient temperature should be 15～35℃.

・ Relative humidity should be 35～80％.

・ Atmospheric pressure should be 795～1062hPa.

・ Spaces should be ≧5cm above top of the machine, ≧

10cm from each of right and left sides of it and ≧20cm from rear side of it.

・ Ventilation port of ≧φ20cm should be provided or at

least one side other than the machine bottom should be exposed to atmosphere.

□OK □NG

13-1

No. Item to be checked

2 Fluid supply and drainage

・ All tubes and lines such as supply and drain tubes

should be free from damages such as folding and bending.

・ Water supply pressure should be 0.049 ～ 0.74MPa (0.5 ～

2

7.5kgf/cm

)

・ Supply water flow rate should be ≧750mL/min.

・ Supply water temperature should be 17～30℃. (If heat exchanger is used, it should be 5～30℃.)

・ Water quality should be suitable for dialysis use.

・ Concentrate line pressure should be -100mmHg (136cm

below inlet) to +100mmHg (136cm above inlet).

・ Drain tube end should not be contacted with waste water

level.

3 Power supply

・ Rating of power supply should conform to that of the

machine.

・ Capacity of power supply should exceed that of the

machine.

4 Ground connection and equipotentialization

・ Pow er supply should be provided with protective ground

terminal.

・ Protective ground conductors of power cord and power

plug should be connected correctly.

5 Connection of power supply

・ Pow er cord plug of the machine should be connected to

receptacle of power supply correctly.

6 Cleaning

・ The machine enclosure should be cleaned.

Paint out □

□OK □NG

□OK NG

□OK □NG

□ OK □NG

13-2

No. Item to be checked

7 Residual disinfectant

・ Residual disinfectant should not be detected by testing

drain water using reagent or test paper.

※ Use copies of these sheets for daily check of the machine.

Paint out □

□OK □NG

13-3

13.2 Procedures for machine operation

1. Turn on power breaker of the machine.

2. Execute prerinsing operation.

3. Execute dialysis.

4. Execute postrinsing.

5. Turn off power breaker of the machine.

13.2.1 Machine SW ON

(1) Check correct connection of power plug to receptacle.

(2) Check no lighting of power lamp.

(3) Turn on power breaker placed at rear side of the machine.

z Power lamp is ON. z Information is displayed on operation panel.

ＳＩＮＧＬＥＰＡＴＩＥＮＴＤＩＡＬＹＳＩＳＭＡＣＨＩＮＥＳＵＲＤＩＡＬＴＹＰＥ Ⅱ ＮＩＰＲＯＣＯＲＰＯＲＡＴＩＯＮＲＡＭ：ＯＫＲＯＭＶｅｒ．３．００／０４ＲＯＭ：ＯＫ

Ｆ・１

Ｆ・２

ＮＯＴＥ

Ｆ・３

Ｆ・４

Ｆ・５

z When recovery from power failure is notified, press [MUTE] SW and [RESET] SW to reset

the machine functions.

13.2.2 Prerinse

(1) Check ON of [DIALYSIS] SW lamp.

(2) Press [DIALYSIS] SW.

z [DIALYSIS] SW lamp is OFF. z Rinse menu screen is displayed.

(3) Follow the procedures specified in Chapter 14 to rinse the machine.

z Rinse the machine before starting dialysis to prevent cross infection among patients.

［ＲＩＮＳＥＭＥＮＵ］ＲＩＮＳＥ１：ＷＡＴＥＲＲＩＮＳＥ３：ＡＵＴＯ１Ｃ＆ＤＲＩＮＳＥ２：ＣＨＥＭＩＣＡＬＲＩＮＳＥ４：ＡＵＴＯ２Ｃ＆ＤＲＩＮＳＥ１ＲＩＮＳＥ２ＲＩＮＳＥ３ＲＩＮＳＥ４ＤＩＳＰ．

Ｆ・１



ＣＡＵＴＩＯＮ

Ｆ・２

Ｆ・３

Ｆ・４

Ｆ・５

13-4