You are on page 1of 198

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

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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

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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 Remove blood and/or organic substances from Remove blood and/or organic substances from
disinfection of machine the machine enclosure using soft cloth wetted the machine enclosure using soft cloth wetted
enclosure with tepid water or water. DO NOT use organic with alcohol or water. DO NOT use organic
※ Delete cleaning procedure solvents such as thinner and benzene to solvents such as thinner and benzene to
using alcohol. prevent patient damage. prevent patient damage.

11-1 11.1.2.Cleaning and After long term use of dialysate concentrate After long term use of dialysate concentrate
disinfection of dialysate connectors and rinse ports, solutes in the connectors and rinse ports, solutes in the
concentrate connectors concentrates may isolated to form harmful concentrates may isolated to form harmful
and rinse ports crystals and may cause the machine failure. crystals and may cause the machine failure.
※ Delete cleaning procedure Clean them using cloth wetted with tepid water Clean them using cloth wetted with alcohol or
using alcohol. or water regularly. Pull out the ports to this water regularly. Pull out the ports to this side to
side to allow easy cleaning. allow easy cleaning.

21-3 21.2.1.Dialysate flow UFR is ≦ 2.70L/h when dialysate flow rate is UFR is ≦ 4.00L/h when dialysate flow rate is
300mL/min. 30L/min.

0R1A01-0105

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CONTENTS
PREFACE

CAUTIONS FOR SAFETY ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ CAUTION-1~6

1. INTENDED USE ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 1-1~2

2. CONTRAINDICATION ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 2-1~2

3. CAUTIONS ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 3-1~2

4. DEFINITIONS ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 4-1~4

5. SYMBOL FOR SAFETY ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 5-1~2

6. INSTALLATION ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 6-1~12

6.1. Installation environment ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・6-1


6.1.1. Ambient conditions ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・6-1
6.1.2. Power supply ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・6-1
6.1.2.1. When machine power rating is AC 230V ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・6-1
6.1.2.2. When machine power rating is AC 100V ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・6-1
6.1.3. Necessary space requirements to use the machine ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・6-2
6.1.4. Water supply and drainage conditions・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・6-2
6.1.4.1. Water supply pressure ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・6-2
6.1.4.2. Water supply flow rate ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・6-2
6.1.4.3. Water supply temperature ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・6-2
6.1.4.4. Water quality・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・6-2
6.1.4.5. Concentrate line pressure ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・6-3
6.1.4.6. Drainage ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・6-3

6.2. Unpacking and check of contents ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・6-4

6.3. Procedure for assembling ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・6-6


6.3.1. Cautions ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・6-6
6.3.2. Attachment of I.V. pole, hanger and main lamp ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・6-6
6.3.3. Connector for each concentrate container ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・6-7

6.4. Procedures for tube and plug connections・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・6-8


6.4.1. Connections of fluid supply and drain lines, coupler and power plug ・・・・・・・・・・・・・・・・6-8
6.4.1.1. Connection of dialysate coupler tubes ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・6-8
6.4.1.2. Connections of drain port of machine side ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・6-8
6.4.1.3. Connection of water supply port ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・6-8
6.4.1.4. Connection of power plug・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・6-8

CONTENTS-1

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6.4.2. Connection of each concentrate・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・6-9
6.4.2.1. Connection to execute dialysis operation(before blood line connection) ・・・・・・・・・6-9
6.4.2.2. Connection for water rinsing ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・6-9
6.4.2.3. Connection for disinfection・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・6-9
6.4.2.4. Connection for acetic acid rinsing (when acid rinse option is not used) ・・・・・・・・・6-10
6.4.2.5. Connection for acetic acid rinsing (when acid rinse option is used) ・・・・・・・・・・・・6-10
6.4.2.6. Connection for automatic rinsing (1 or 2)(when acid rinse option is used) ・・・・・・・6-10
6.4.3. Air purge・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・6-11

6.5. Disinfection of the dialysate circuit ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・6-12

6.6. Disposal of used machine・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・6-12

6.7. Disposal of used packaging materials ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・6-12

6.8. Disposal of blood lines and dialyzer ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・6-12

7. MAIN FUNCTIONS AND COMPONENTS ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 7-1~2

8. CONSTRUCTION OF MACHINE ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 8-1~14

8.1. Overall construction ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・8-1


8.1.1. Overall views ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・8-1
8.1.2. Components of machine and their purposes and functions ・・・・・・・・・・・・・・・・・・・・・・・・8-3

8.2. Operation panel ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・8-5


8.2.1. Construction of operation panel ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・8-5
8.2.2. Components of operation panel and their purposes and functions・・・・・・・・・・・・・・・・・・8-6

8.3. Blood line setting panel ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・8-9


8.3.1. Construction of blood line setting panel・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・8-9
8.3.2. Components of blood line setting panel and their purposes and functions ・・・・・・・・・・8-10

8.4. Power box ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・8-11


8.4.1. Construction of power box・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・8-11
8.4.2. Components of power box and their purposes and functions ・・・・・・・・・・・・・・・・・・・・・8-12

8.5. Main lamp assembly ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・8-13


8.5.1. Construction of main lamp assembly ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・8-13
8.5.2. Components of main lamp assembly and their purposes and functions ・・・・・・・・・・・・8-14

CONTENTS-2

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9. DISPLAY ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 9-1~18

9.1. Layout of display ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・9-3

9.2. Wake up screen ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・9-5

9.3. Rinse screen ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・9-6


9.3.1. Rinse menu ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・9-6
9.3.2. Rinse wait・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・9-7
9.3.2.1. RINSE1: WATER・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・9-7
9.3.2.2. RINSE2:CHEMICAL ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・9-7
9.3.2.3. RNSE3:AUTO1 C&D・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・9-7
9.3.2.4. RINSE4: AUTO2 C&D ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・9-8
9.3.3. Rinse execution・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・9-9
9.3.3.1. RINSE1: WATER・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・9-9
9.3.3.2. RINSE2: CHEMICAL・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・9-9
9.3.3.3. RINSE3: AUTO1 C&D ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・9-9
9.3.3.4. RINSE4: AUTO2 C&D ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・9-9
9.3.4. Rinse end ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・9-10
9.3.4.1. RINSE1: WATER・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・9-10
9.3.4.2. RINSE2:CHEMICAL ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・9-10
9.3.4.3. RINSE3:AUTO1 C&D ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・9-10
9.3.4.4. RINSE4:AUTO2 C&D ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・9-10

9.4. Dialysis screen ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・9-11


9.4.1. Dialysis ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・9-11
9.4.2. Priming ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・9-12
9.4.3. Test mode ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・9-13

9.5. SettingⅠ screen ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・9-14

9.6. SettingⅡ screen ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・9-15

9.7. Maintenance menu screen ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・9-16

9.8. Alarm screen・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・9-17

10. ALARM FUNCTIONS AND RESETTING ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 10-1~14

10.1. Description of alarms・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・10-1


10.1.1. Functions when error is alerted ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・10-1
10.1.2. Procedure for resetting ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・10-2
10.1.3. Actions to respond to alarm (flow) ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・10-2

10.2. Table of alarms・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・10-3


10.2.1. Meanings of terms contained in “Table of alarms” ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・10-3
10.2.2. Table of alarms ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 10-3~14

CONTENTS-3

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11. CLEANING AND DISINFECTION ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 11-1~8

11.1. Cleaning and disinfection of machine outside ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・11-1


11.1.1. Machine enclosure ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・11-1
11.1.2. Dialysate concentrate connectors and rinse ports・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・11-1

11.2. Cleaning and disinfection of fluid lines ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・11-1

11.3. Disinfection of fluid line inside ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・11-2


11.3.1. Concentration of disinfectant concentrate・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・11-2
11.3.2. Diluted disinfectant concentration and disinfection time ・・・・・・・・・・・・・・・・・・・・・・・・・11-2
11.3.3. Method to set dilution rate of disinfectant concentrate ・・・・・・・・・・・・・・・・・・・・・・・・・・11-3
11.3.4. Check of residual disinfectant・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・11-3

11.4. Removal of calcium deposit from fluid line inside ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・11-4


11.4.1. Concentration of acetic acid concentrate ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・11-4
11.4.2. Diluted disinfectant concentration and disinfection time ・・・・・・・・・・・・・・・・・・・・・・・・・11-4
11.4.3. Concentration of acetic acid to be diluted ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・11-4
11.4.4. Method to set dilution rate of acetic acid concentrate ・・・・・・・・・・・・・・・・・・・・・・・・・・・11-5
11.4.5. Check of residual acetic acid ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・11-5

11.5. Removal of protein deposit from fluid line inside・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・11-6


11.5.1. Concentration of sodium hypochlorite ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・11-6
11.5.2. Diluted disinfection concentration and disinfection time ・・・・・・・・・・・・・・・・・・・・・・・・・11-6
11.5.3. Concentration of sodium hypochlorite to be diluted ・・・・・・・・・・・・・・・・・・・・・・・・・・・・11-7
11.5.4. Check of residual sodium hypochlorite ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・11-7

12. PROCESS FLOW ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 12-1~4

12.1. Process flow ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・12-1

12.2. Description of process flow・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・12-2


12.2.1. Rinse wait process ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・12-2
12.2.2. Rinse process ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・12-2
12.2.2.1. Water rinse mode ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・12-2
12.2.2.2. Disinfection/rinse mode ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・12-2
12.2.2.3. Acid rinse mode ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・12-2
12.2.2.4. Dwelling mode ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・12-2
12.2.2.5. Prerinse mode ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・12-2
12.2.3. Rinse end process ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・12-3
12.2.4. Dialysis wait process ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・12-3
12.2.5. Preparation process ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・12-3
12.2.6. Preparation end process ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・12-3
12.2.7. Dialysis process ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・12-3
12.2.8. Recovery process・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・12-3
12.2.9. Air purge process ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・12-3

CONTENTS-4

Downloaded from www.Manualslib.com manuals search engine


13. OPERATION OF MACHINE ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 13-1~4

13.1. Check and action before turning on power breaker ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・13-1

13.2. Procedures for machine operation ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・13-3


13.2.1. Machine SW ON ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・13-3
13.2.2. Prerinse ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・13-3
13.2.3. Dialysis ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・13-4
13.2.4. Postrinse ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・13-4
13.2.5. Machine power breaker OFF ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・13-4

14. RINSING ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 14-1~6

14.1. Selection of rinsing mode ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・14-2

14.2. Setting of rinsing pattern (example: RINSE4 (AUTO2 C&D))・・・・・・・・・・・・・・・・・・・・・・・14-2

14.3. Connection of concentrates ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・14-3

14.3.1. Connection of concentrates when acid rinse port (option) is not used ・・・・・・・・・・・14-3
14.3.1.1. Connection at water rinse ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・14-3
14.3.1.2. Connection at disinfection/rinse ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・14-3
14.3.1.3. Connection at acid rinse・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・14-3

14.3.2. Connection of concentrates when acid port unit (option) is used ・・・・・・・・・・・・・・・・・14-4
14.3.2.1. Connection at water rinse ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・14-4
14.3.2.2. Connection at disinfection/rinse ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・14-4
14.3.2.3. Connection at acid rinse・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・14-4
14.3.2.4. Connection at auto rinse 1 or 2 ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・14-4

14.4. Start of rinsing (example: RINSE4(AUTO2 C&D)) ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・14-5

14.5. Completion of rinsing・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・14-5

14.6. Discontinuance of rinsing ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・14-6

15. DOUBLE NEEDLE DIALYSIS ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 15-1~20

15.1. Setting of dialysate related parameters ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・15-2


15.1.1. Setting of dialysis mode・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・15-2
15.1.2. Setting of dialysate concentration ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・15-2
15.1.2.1. Bicarbonate dialysate ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・15-2
15.1.2.2. Acetate dialysate ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・15-3
15.1.3. Setting of dialysate temperature・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・15-3

CONTENTS-5

Downloaded from www.Manualslib.com manuals search engine


15.2. Connection of concentrates ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・15-4
15.2.1. Connection of concentrates to prepare bicarbonate dialysate・・・・・・・・・・・・・・・・・・・・15-4
15.2.2. Connection of concentrate to prepare acetate dialysate ・・・・・・・・・・・・・・・・・・・・・・・・15-4

15.3. Setting of blood line, dialyzer and syringe ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・15-5


15.3.1. Setting of blood line ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・15-5
15.3.2. Setting of dialyzer ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・15-5
15.3.3. Setting of syringe ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・15-5
15.3.4. Setting of syringe pump ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・15-5
15.3.4.1. Setting of cross-section ratio of syringe ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・15-5
15.3.4.2. Setting of syringe operation stop time ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・15-7
15.3.4.3. Setting of fast-forward volume・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・15-7

15.4. Preparation of machine (preparation process) ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・15-8

15.5. Check of preparation completion of machine (preparation end process) ・・・・・・・・・・・・・・15-8

15.6. Priming process ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・15-9


15.6.1. Setting of saline vial ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・15-9
15.6.2. Priming of saline ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・15-9
15.6.3. Priming of dialyzer with dialysate ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 15-10
15.6.4. Rinsing of blood line and dialyzer ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 15-10
15.6.4.1. When priming function is used ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 15-10
15.6.4.2. When priming function is not used ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 15-11

15.7. Check of dialysate conductivity ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 15-12

15.8. Setting of UF related parameters ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 15-12

15.9. Connection of patient ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 15-13

15.10. Start of dialysis (dialysis process) ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 15-14


15.10.1. Start of dialysis ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 15-14
15.10.2. Setting of upper and lower venous pressure alarm limits・・・・・・・・・・・・・・・・・・・・・ 15-14
15.10.3. Setting of upper and lower arterial pressure alarm limits ・・・・・・・・・・・・・・・・・・・・・ 15-14
15.10.4. Setting of upper and lower dialysate pressure alarm limits ・・・・・・・・・・・・・・・・・・・ 15-15

15.11. Completion of dialysis (recovery process) ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 15-16


15.11.1. Check of UF completion ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 15-16
15.11.2. Start of blood recovery・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 15-16
15.11.3. Execution of blood recovery ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 15-17
15.11.4. Removal of coupler ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 15-17
15.11.5. Clearing away ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 15-18
15.11.6. Completion of blood recovery・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 15-18

15.12. Discontinuance of dialysis ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 15-19


15.12.1. Discontinuance of UF・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 15-19
15.12.2. Discontinuance of dialysis・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 15-19

CONTENTS-6

Downloaded from www.Manualslib.com manuals search engine


16. SINGLE NEEDLE DIALYSIS ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 16-1~20

16.1. Setting of dialysate related parameters ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・16-2


16.1.1. Setting of dialysis mode・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・16-2
16.1.2. Setting of dialysate concentration ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・16-2
16.1.2.1. Bicarbonate dialysate ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・16-2
16.1.2.2. Acetate dialysate ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・16-3
16.1.3. Setting of dialysate temperature・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・16-3

16.2. Connection of concentrates ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・16-4


16.2.1. Connection of concentrates to prepare bicarbonate dialysate・・・・・・・・・・・・・・・・・・・・16-4
16.2.2. Connection of concentrate to prepare acetate dialysate ・・・・・・・・・・・・・・・・・・・・・・・・16-4

16.3. Setting of blood line, dialyzer and syringe ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・16-5


16.3.1. Setting of blood line ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・16-5
16.3.2. Setting of dialyzer ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・16-5
16.3.3. Setting of syringe ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・16-5
16.3.4. Setting of syringe pump ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・16-6
16.3.4.1. Setting of cross-section ratio of syringe ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・16-6
16.3.4.2. Setting of syringe operation stop time ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・16-7
16.3.4.3. Setting of fast-forward volume・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・16-7

16.4. Preparation of machine (preparation process) ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・16-8

16.5. Check of preparation completion of machine (preparation end process) ・・・・・・・・・・・・・・16-8

16.6. Priming process ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・16-9


16.6.1. Setting of saline vial ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・16-9
16.6.2. Priming of saline ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・16-9
16.6.3. Priming of dialyzer with dialysate ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 16-10
16.6.4. Rinsing of blood line and dialyzer ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 16-10
16.6.4.1. When priming function is used ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 16-10
16.6.4.2. When priming function is not used ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 16-11

16.7. Check of dialysate conductivity ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 16-12

16.8. Setting of UF related parameters ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 16-12

16.9. Connection of patient ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 16-13

16.10. Setting of single needle dialysis related parameters ・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 16-14


16.10.1. Single needle SW ON ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 16-14
16.10.2. Setting of single needle changeover values・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 16-14

16.11. Start of dialysis (dialysis process) ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 16-15


16.11.1. Start of dialysis ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 16-15

CONTENTS-7

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16.11.2. Setting of upper and lower arterial pressure alarm limits ・・・・・・・・・・・・・・・・・・・・・ 16-15
16.11.3. Setting of upper and lower dialysate pressure alarm limits ・・・・・・・・・・・・・・・・・・・ 16-16

16.12. Completion of dialysis (recovery process) ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 16-17


16.12.1. Check of UF completion ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 16-17
16.12.2. Start of blood recovery・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 16-17
16.12.3. Execution of blood recovery ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 16-18
16.12.4. Removal of coupler ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 16-18
16.12.5. Clearing away ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 16-19
16.12.6. Completion of blood recovery・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 16-19

16.13. Discontinuance of dialysis ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 16-20


16.13.1. Discontinuance of UF・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 16-20
16.13.2. Discontinuance of dialysis・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 16-20

17. SEQUENTIAL DIALYSIS ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 17-1~2

17.1. ON setting of sequential dialysis ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・17-1

17.2. OFF setting of sequential dialysis ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・17-1

18. CHECK AND MAINTENANCE・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 18-1~22

18.1. Check and maintenance by operator ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・18-1


18.1.1. Check and maintenance before and after operation ・・・・・・・・・・・・・・・・・・・・・・・・・・・・18-1
18.1.1.1. Test mode・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・18-1
18.1.2. Cleaning and disinfection of machine outside ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・18-2
18.1.3. Disinfection and rinsing of fluid line inside ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・18-2
18.1.4. Acetic acid rinsing of fluid lines・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・18-2

18.2. Regular check by engineer・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・18-3


18.2.1. Check before power ON ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・18-4
18.2.2. Check of leakage current・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・18-5
18.2.3. Check of accuracy of pressure sensor ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・18-6
18.2.4. Check of syringe pump ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・18-7
18.2.4.1. Check for fixation of pulley・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・18-7
18.2.4.2. Check for accuracy of syringe pump ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・18-7
18.2.5. Check of accuracy of UF ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・18-8
18.2.6. Check of accuracy of blood leak sensor ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・18-9
18.2.6.1. Visual check of blood leak sensor・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・18-9
18.2.6.2. Zero revisions of blood leak sensor ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 18-10
18.2.7. Check of accuracy of blood pump flow rate ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 18-11
18.2.7.1. When electronic balance is used ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 18-11
18.2.7.2. When measuring cylinder is used ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 18-11

CONTENTS-8

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18.2.8. Check of accuracy of bubble sensor ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 18-12
18.2.8.1. Preferable method・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 18-12
18.2.8.2. Simple method ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 18-12
18.2.9. Check of accuracy of temperature sensor ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 18-13
18.2.10. Check of accuracy of conductivity cell・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 18-14
18.2.11. Replacement of components of GVS filter (Supply water line) ・・・・・・・・・・・・・・・・ 18-15
18.2.12. Replacement of components of electromagnetic valve ・・・・・・・・・・・・・・・・・・・・・・ 18-16
18.2.13. Replacement of component of pump・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 18-18
18.2.13.1. Overall views of pump ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 18-18
18.2.13.2. Contents parts list ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 18-18
18.2.13.3. Replace method ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 18-20

18.3. Maintenance by qualified engineer ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 18-22

19. STORAGE ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 19-1~2

19.1. Actions before storing machine ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・19-1


19.1.1. Cleaning of enclosure ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・19-1
19.1.2. Priming of formalin solution・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・19-1

19.2. Environmental conditions required to store machine ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・19-2

19.3. Check and test before re-operation of machine ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・19-2

20. MACHINE MOVING AND CAUTIONS ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 20-1~2

21. SPECIFICATIONS ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 21-1~12

21.1. Specifications for machine ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・21-1


21.1.1. Dimension and weight ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・21-1
21.1.2. Power source ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・21-1
21.1.3. Electric safety ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・21-1
21.1.4. Environment ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・21-2

21.2. Performance of machine・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・21-3


21.2.1. Dialysate flow rate ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・21-3
21.2.2. Deaeration ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・21-3
21.2.3. UFR control ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・21-3
21.2.4. Temperature control ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・21-3
21.2.5. Conductivity control (BICARBONATE) ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・21-4
21.2.6. Conductivity control (ACETATE) ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・21-4
21.2.7. Disinfection control ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・21-5

CONTENTS-9

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21.2.8. Acid rinse control ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・21-5
21.2.9. Water rinse control ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・21-5
21.2.10. Blood pump ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・21-6
21.2.11. Syringe pump ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・21-6

21.3. Safety monitors ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・21-7


21.3.1. Venous pressure monitor ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・21-7
21.3.2. Dialysate pressure monitor ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・21-7
21.3.3. Bubble detector・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・21-7
21.3.4. Blood leak detector・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・21-8
21.3.5. Temperature monitor ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・21-8
21.3.6. Conductivity monitor・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・21-8

21.4. Specifications for options ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・21-9


21.4.1. Arterial pressure sensor・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・21-9
21.4.2. Backup unit of blood pump for power failure ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・21-9
21.4.2.1. Machine specification ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・21-9
21.4.2.2. Energy cell specification・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・21-9
21.4.3. Heat exchanger・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 21-10
21.4.4. Acid rinse port unit ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 21-10
21.4.5. Hot rinse Assy ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 21-10
21.4.5.1. Hot chemical disinfectant rinse control・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 21-10
21.4.5.2. Hot water rinse・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 21-11
21.4.6. Large single lump assy ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 21-11

21.5. Special note ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 21-11


21.5.1. Language ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 21-11

22. DATA FOR USE ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 22-1~8

22.1. Blood tubing set applicable to SURDIAL ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・22-1


22.1.1. A065(A067) / V643 ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・22-1
22.1.2. A064(A066) / V643 ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・22-2
22.2. Layouts of blood tubing ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・22-4
22.2.1. Model A065(A067) / V643 ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・22-4
22.2.2. Model A064(A066) / V643 ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・22-5
22.3. Flow chart and components of SURDIAL ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・22-6
22.3.1. Flow chart ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・22-6
22.3.2. Component of SURDIAL ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・22-7

CONTENTS-10

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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

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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

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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

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■ 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.

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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.

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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.

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Chapter 2

CONTRAINDICATION

Any application other than dialysis is contraindicated.

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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.

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4. Cautions during operation
(1) Monitor always whether the machine and patient are maintained normally.
(2) If trouble of the machine or patient is detected, take appropriate actions such as
the machine stop so that the patient is kept safe.
(3) Take care that there is no direct contact of the machine to patient.

5. Cautions after operation


(1) Turn off power after returning operation SW’s, dials and the like to original
positions based on prescribed procedures.
(2) DO NOT forcibly pull any cord and the like to disconnect..
(3) Take care the followings to store or transport the machine:
1) Store the machine at place without fear of contact with water.
2) Store the machine at place without fear of adverse effects caused by
abnormal atmospheric pressure, temperature and/or humidity; insufficient
ventilation, direct exposure to sunlight; and dust, salt and/or sulfur
containing air.
3) Handle the machine under avoiding slant placement, vibration and shock
during storage and transportation.
4) DO NOT store the machine at chemical storing or gas generating place.
(4) Clean accessories, cords, and the like in order and clean them to store.
(5) Store the machine after cleaning it for the next use without any trouble.

6. If the machine is damaged, indicate the damaged conditions to request


repair by specialist.

7. DO NOT remodel or modify the machine.

8. Check and maintenance


(1) Perform regular check and maintenance of the machine and its components.
(2) When the machine is used after storage for some time, check and maintain so that
it can be operated normally and safely.

9. Read and understand other CAUTIONS contained in the operation manual.

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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

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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.

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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.

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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】

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5. SPECIFICATIONS

Specification Required condition


Allowable set range -400~+400mmHg No

Allowable indication Digital indication -400 to No


range +400mmHg
Indicator indication - -400 ~
+400mmHg
Accuracy of indicated Actual pressure±10mmHg、 Excluding indicator
value or ±10% (F.S.) whichever greater

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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 :
Storage for one month
Transport
Use Daily storage or more; and Transport
without fluid
with contained fluid
Temp. (°C) 15 to 35 10 to 40 5 to 50 -10 to 50

Relative humidity 35 to 80 15 to 85 15 to 85 15 to 85
(%) No condensing
Atmospheric 795 to
795 to 1062 795 to 1062 700 to 1062
pressure (hPa) 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.

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WARNING
DO NOT use AC power plug or adapter disconnecting safety earth.
DO NOT connect the machine plug to receptacle through adapter.
If power installation is suspected to have any problem, request check of wiring by electric
engineer.

6.1.3. Necessary space requirements to use the machine

Space above the top of the machine should be ≧ 5 cm, that at each of right and left sides
should be ≧ 10 cm and that at rear side should be ≧ 20 cm.
A ventilation port with a diameter ≧ 20 cm should be provided or any side other than bottom
should be cleared so that the side is completely exposed to atmosphere.

6.1.4. Water supply and drainage conditions

Water supply and drainage conditions should be checked for normal operation of the machine.

6.1.4.1. Water supply pressure

Pressure : 0.049 to 0.74 MPa (0.5 to 7.5 kgf/cm2)

6.1.4.2. Water supply flow rate

Flow rate : ≧ 750 mL/min

6.1.4.3. Water supply temperature

Temperature : 17 to 30 °C.
The temperature should be lower than the set dialysate temperature by ≧ 5 °C.
If heat exchanger is used, the temperature should be 5-30 °C which should be lower than the
set dialysate temperature by ≧ 5 °C.

6.1.4.4. Water quality

Supply water must be filtered through a 25 µm filter and the quality must be soft. The quality
must be monitored by regular analysis to maintain the acceptable quality.

WARNING
Use water of quality meeting AAMI - approved American National Standard for
Haemodialysis System, RD5, 1981, Section 3.2.
Otherwise, patient may suffer from seriously adverse effects.

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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.

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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

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(f) Blood pump handle (×1)

(g) Coupler set (×1)

(h) Disinfectant concentrate


container connection set (×1)

(i) Dialysate concentrate container


connection set
(One for each of A and B)

(j) Dialyzer holder (×1)


(k) Tube holder (×2) (L) CL filter (×1)

Fig.6-1 Accessories

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6.3. Procedure for assembling

6.3.1. Cautions

Take care of the followings at assembling.


(a) Place the machine on horizontal and stable floor.
(b) Sufficient space to assemble should be provided.
(c) Use accessories packaged with the machine and/or designated option to assemble.

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

Fig. 6-2 Attachment of I.V. pole

Attach the pole to the machine as shown in Fig. 6-2. Harness can be easily passed through the pole
by binding strand to the machine side connector followed by passing the connector bound strand
through the pole. Engage the connector with the lamp side connector securely.
Wires of the both connectors are colored as shown in the below Table:
Machine side (Letters on tube) Lamp side
Black or white (LAMP) Black or white
Red Red

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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

Cut off

Suction port

Fig. 6-4 Preparation of suction port

NOTE
If the container is provided with 2 ports closed with respective caps, engage the
connector with one of the ports and loosen the cap of the other port to allow air
introduction.
If the container is provided with only one port closed by one cap, engage the connector
with the port and loosen the cap to allow air introduction.
The caps (L and S) are not provided with the machine. Use L or S cap of the containers.
Prepare 3 or 4 connectors for containers receiving A, B and disinfectant concentrates;
and for container receiving acetic acid concentrate as option.

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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.

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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.

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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.

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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.

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

F・1 F・2 F・3 F・4 F・5

(6) After checking display of [MAINTE 9], press [F・1] SW to start the air purge process.

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

F・1 F・2 F・3 F・4 F・5

(7) To terminate the process forcibly during its execution, press [F・1] SW.

[MAINTE 9]
FILLING

STOP

F・1 F・2 F・3 F・4 F・5

(8) Upon completion of the process, it is shown in the message screen.

[MAINTE 9]
END OF FILLING

MENU

F・1 F・2 F・3 F・4 F・5

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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.

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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)


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Chapter 8
CONSTRUCTION OF MACHINE

8.1 Overall construction

8.1.1 Overall views

Main
l

Operation
l
Blood line setting
l

Front view Right side

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

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Power supply

Rear side view Left side view

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

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8.1.2 Components of machine and their purposes and functions

No. Component Purpose and function

1 Sampling port Port used to take dialysate sample

2 Rinse port for A Port used to connect to connector of A concentrate


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

4 Rinse port for B Port used to connect connector of B concentrate


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

6 Flow meter Meter use to indicate flow rate of dialysate supplied to


dialyzer
7 Dialysate return tube Tube used to return used dialysate to port “From
Dialyzer”

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

9 Dialysate return coupler Coupler used to connect used dialysate return tube to
dialyzer
10 Dialysate supply coupler Coupler used to connect fresh dialysate supply tube to
dialyzer
11 Bypass connector Connector used to bypass ports “From Dialyzer” and
“To Dialyzer” when couplers Nos. 9 and 10 are set to
the machine during rinsing operation
12 Limit SW for bypass SW used to detect whether coupler is received in
connector coupler holder
13 Coupler holder Holder used to receive coupler during rinsing operation

14 Dialysate flow rate Valve used to regulate dialysate flow rate in closed
regulating needle valve circuit
15 Container support Support used to load dialysate concentrate container

16 Port “From Dialyzer” Port used to return used dialysate from dialyzer

17 Port “To Dialyzer” Port used to supply fresh dialysate to dialyzer

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No. Component Purpose and function

18 Water supply port Port used to connect hose for supplying purified water
to the machine
19 Drain port Port used to connect hose for draining used dialysate

20 Port for connector of Port use to connect connector of disinfectant


disinfectant concentrate concentrate container when disinfectant or acid rinsing
connector is not executed
21 Connector for disinfectant Connector used to connect disinfectant concentrate
concentrate container container during disinfection/rinsing; or that used to
connect
acetic acid concentrate container during acid rinsing
22 Blood leak sensor Sensor used to detect blood leak

23 Priming flow rate regulating Valve used to regulate flow rate of priming solution
needle valve
24 Tray Tray used to hold tools during dialysis by placing it on
the machine top

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8.2 Operation panel

8.2.1 Construction of operation panel

Fig. 8-2 Operation panel

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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 by
lamp lighting.
“During preparation” is indicated by lamp flashing.
3 [UF DIALYSE] SW with SW used to start UF
lamp “During UF” is indicated by lamp lighting.

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


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

6 [RINSE] SW with lamp SW used to start rinsing of fluid lines of the machine
“During rinsing” is indicated by lamp lighting.
7 CONDITION lamp Lamp used to indicate operating condition
“During UF” is indicated by green lighting and “during
alarm actuation” is indicated by red lighting.
8 [MUTE] SW with lamp “Alarm actuation” is indicated by lamp lighting. By
pressing SW, buzzing is muted and lamp is OFF.
9 [RESET] SW with lamp “Alarm actuation” is indicated by lamp lighting. By
pressing SW after muting buzzer, alarm is released and
lamp is OFF.
10 POWER lamp “Power SW ON” is indicated by lamp lighting.

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


alerted condition, etc. for monitoring them.
12 Venous pressure indicator Indicator used to show VP by bar graph
Upper and lower limits of set VP range are also shown
by different colors.
13 Set upper VP limit SW used to increase set upper VP limit within
increasing SW acceptable range
14 Set upper VP limit SW used to decrease set upper VP limit within
decreasing SW acceptable range

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No. Component Purpose and function

15 Set lower VP limit SW used to increase set lower VP limit within


increasing SW acceptable range
16 Set lower VP limit SW used to decrease set lower VP limit within
decreasing SW 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 SW used to increase set upper DP or AP limit within
increasing SW acceptable range
21 Set upper DP/AP limit SW used to decrease set upper DP or AP limit within
decreasing SW acceptable range
22 Set lower DP/AP limit SW used to increase set lower DP or AP limit within
increasing SW acceptable range
23 Set lower DP/AP limit SW used to decrease set lower DP or AP limit within
decreasing SW 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 used to indicate total UF volume at this time
LED digitally
26 [UF RESET] SW 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
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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 use to activate bubble sensor
SW with lamp Sensor activation is indicated by lamp lighting.
42 Syringe pump fast infusion 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 used to operate syringe pump
SW with lamp Pump operation is indicated by lamp lighting.
47 Blood pump flow rate 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 SW used to operate blood pump
with lamp Pump operation is indicated by lamp lighting.

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8.3 Blood line setting panel

8.3.1 Construction of blood line setting panel

Fig. 8-3 Blood line setting panel

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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

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8.4 Power supply

8.4.1 Construction of power supply

Fig. 8-4 Power supply

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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.

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8.5 Main lamp assembly

8.5.1 Construction of main lamp assembly

Fig. 8-5 Main lamp assembly

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8.5.2 Components of main lamp assembly and their purposes and functions

No. Component Purpose and function

1 Main lamp Lamp used to alert error visually

2 Hanger Hanger used to suspend vial and the like

3 I.V. pole Pole used to hold dialyzer and the like

4 Set screw Screw used to fix hanger to I.V. pole

5 O-ring (×2) Rings used to cushion fixed hanger

6 Main lamp cap Cap used to support main lamp

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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 5] SW (MENU)
[F 1][F 2] SW


(MODE


* )

…See “Service Manual”. Maintenance


1-10 screens

Fig. 9-1 Screen flow

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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.

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9.1. Layout of display

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

① ② ③

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,

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

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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.

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

SINGLE PATIENT DIALYSIS MACHINE


SURDIAL TYPE Ⅱ
NIPRO CORPORATION RAM:OK
ROM Ver.3.00/01 ROM: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.

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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.

[RINSE MENU]
RINSE1:WATER RINSE3:AUTO1 C&D
RINSE2:CHEMICAL RINSE4:AUTO2 C&D
RINSE1 RINSE2 RINSE3 RINSE4 DISP.

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

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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 >


WATER RINSE 30min

+ - 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 >


CHEMICAL RINSE 30min

+ - 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→-----→-----
PRERINSE START TOMORROW 10:00
+ - < > MENU

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

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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→-----→-----
PRERINSE START TOMORROW 10:00
+ - < > 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※※ Start of prerinse at time set by PRERINSE START
----- No operation
PRERINSE START Setting of prerinse start time within period from this
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.

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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 >


WATER RINSE 15min

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 >


CHEMICAL RINSE 15min

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→PRE30
PRERINSE START TOMORROW 10:00
DISP.

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→PRE30
PRERINSE START TOMORROW 10:00
DISP.

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

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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 >


WATER RINSE 00min

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 >


CHEMICAL RINSE 00min

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→PRE00
PRERINSE START TODAY 10:00
DISP.

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→PRE00
PRERINSE START TODAY 10:00
DISP.

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

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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: 140mmHg DP: 100mmHg COND:14.0mS/cm
AP:-100mmHg TMP: 40mmHg TEMP:37.0゜C
S.N. SQHD PRIM TEST DISP.

Fig. 9-17 Dialysis screen

INDICATION DESCRIPTION

VP Current venous pressure

AP Current arterial pressure


Displayed only when required option is used
DP Current 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.

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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]
SOLUTION VOL.(l):5.00
ACCUMULATED VOL.(l):5.00 RATIO(%):100
+ - EXIT DISP.

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

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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:OK CLV:OK BD: VPa: VPb:
VP: AP:
EXIT DISP.

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.

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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):37.0 2.BAR GRAPH :DP
3.S.STP(min): 0 4.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.

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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) :140 2.BC(W+A) :110
3.AC(W+AC) :140 4.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.

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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.

[MAINTE MENU(1/5)]
MODE1:DATA
MODE2:ALARM SETTING
MODE1 MODE2 P.UP P.DOWN DISP.

Fig. 9-22 Maintenance mode menu screen

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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.E24 AIR BUBBLE ARE DETECTED
2.E26 SHORT WATER SUPPLY
UP DOWN DISP.

Fig. 9-23 Alarm screen

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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.

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(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

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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 by 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.

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

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10.2.2 Table of alarms

BP
Alarm Detection Detection Fluid line CLV Alarm
Alarm name Audible alarm SP Resetting and note
No. condition process function close release
stop
E01 RECOVER FROM Return to normal after •Rinse ○(3 times) Execution of ― ― ― Automatic return to normal
EMERGENCY STOP power failure caused •Preparation sequence before Becoming error free of set upper and lower
during sequence •Preparation end error detection VP/ AP/ DP alarm limits by alarm actuation
execution •Dialysis
•Recovery
E02 T1 TEMPERATURE T1 temperature exceeding •Rinse wait •○(7 times) •Continuance ― ― ○ Return to normal by pressing [RESET] SW
SENSOR ERROR measurable temperature •Rinse •Same as above •Same as above
•Rinse end •Same as above •Same as above
•Air purge •Same as above •Same as above
•Dialysis wait •○(Continuous) •Same as above
•Preparation •Same as above •Fluid line stop
•Preparation end •Same as above •Same as above
•Dialysis •Same as above •Same as above
•Recovery •Same as above •Same as above
E03 T2 TEMPERATURE T2 temperature exceeding •Rinse wait •○(7 times) •Continuance ― ― ○ Return to normal by pressing [RESET] SW
SENSOR ERROR measurable temperature •Rinse •Same as above •Same as above During rinse process, upper value of
•Rinse end •Same as above •Same as above measurable range could not be detected.
•Air purge •Same as above •Same as above
•Dialysis wait •○(Continuous) •Same as above
•Preparation •Same as above •Fluid line stop
•Preparation end •Same as above •Same as above
•Dialysis •Same as above •Same as above
•Recovery •Same as above •Same as above
E04 T3 TEMPERATURE T3 temperature exceeding •Rinse wait •○(7 times) •Continuance ― ― ○ [Return to normal by pressing [RESET] SW
SENSOR ERROR measurable temperature •Rinse •Same as above •Same as above
•Rinse end •Same as above •Same as above
•Air purge •Same as above •Same as above
•Dialysis wait •○(Continuous) •Same as above
•Preparation •Same as above •Fluid line stop
•Preparation end •Same as above •Same as above
•Dialysis •Same as above •Same as above
•Recovery •Same as above •Same as above
E05 DIALYSATE Dialysate temperature (T3) •Preparation ○(Continuous) Auto bypass ― ― ○ Return to normal by pressing [RESET] SW
TEMPERATURE of ≧ set upper alarm limit •Preparation end Heater OFF Auto reset after release from detection
MAX ALARM •Dialysis condition for 10 sec
•Recovery

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BP
Alarm Detection Detection Fluid line CLV Alarm
Alarm name Audible alarm SP Resetting and note
No. condition process function close release
stop
E06 DIALYSATE Dialysate temperature (T3) Dialysis ○(3 times) Auto bypass ― ― ○ Return to normal by pressing [RESET] SW
TEMPERATURE of ≦set lower alarm limit Auto reset after release from detection
MIN ALARM condition for 10 sec
E07 DIALYSATE PRESSURE Dialysate pressure of•Rinse wait •○(7 times) UF stop 2 sec 2 sec ○ Auto return of BP/SP/CLV to normal
MAX LIMIT ≧+400mmHg •Rinse •Same as above V4,V10 ON for 2 Return of UF stop to normal by pressing
•Rinse end •Same as above sec [RESET] SW
•Air purge •Same as above
•Dialysis wait •○(Continuous)
•Preparation •Same as above
•Preparation end •Same as above
•Dialysis •Same as above
•Recovery •Same as above
E08 DIALYSATE PRESSURE Dialysate pressure of •Rinse wait •○(7 times) UF stop 2 sec 2 sec ○ Auto return of BP/SP/CLV to normal
MIN LIMIT ≦-400mmHg •Rinse •Same as above V4,V10 ON for 2 Return of UF stop to normal by pressing
•Rinse end •Same as above sec [RESET] SW
•Air purge •Same as above
•Dialysis wait •○(Continuous)
•Preparation •Same as above
•Preparation end •Same as above
•Dialysis •Same as above
•Recovery •Same as above
E09 DIALYSATE PRESSURE Dialysate pressure of ≧ •Dialysis wait ○(Continuous) UF stop 2 sec 2 sec ○ Auto return of BP/SP/CLV to normal
MAX ALARM set upper alarm limit •Preparation V4,V10 ON for 2 Return of UF stop to normal by pressing
•Preparation end sec [RESET] SW
•Dialysis Becoming error free of set upper and lower
•Recovery VP alarm limits by alarm actuation
E10 DIALYSATE PRESSURE Dialysate pressure of ≦ •Dialysis wait ○(Continuous) UF stop 2 sec 2 sec ○ Auto return of BP/SP/CLV to normal
MIN ALARM set lower alarm limit •Preparation V4,V10 ON for 2 Return of UF stop to normal by pressing
•Preparation end sec [RESET] SW
•Dialysis Becoming error free of set upper and lower
•Recovery VP alarm limits by alarm actuation
E11 VENOUS PRESSURE Venous pressure of •Rinse wait •○(7 times) UF stop ○ ― ○ Return to normal by pressing [RESET] SW
MAX LIMIT ≧+400mmHg •Rinse •Same as above
•Rinse end •Same as above
•Air purge •Same as above
•Dialysis wait •○(Continuous)
•Preparation •Same as above
•Preparation end •Same as above
•Dialysis •Same as above
•Recovery •Same as above

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BP
Alarm Detection Detection Fluid line CLV Alarm
Alarm name Audible alarm SP Resetting and note
No. condition process function close release
stop
E12 VENOUS PRESSURE MIN Venous pressure of •Rinse wait •○(7 times) UF stop ○ ― ○ Return to normal by pressing [RESET] SW
LIMIT ≦-400mmHg •Rinse •Same as above
•Rinse end •Same as above
•Air purge •Same as above
•Dialysis wait •○(Continuous)
•Preparation •Same as above
•Preparation end •Same as above
•Dialysis •Same as above
•Recovery •Same as above
E13 VENOUS PRESSURE Venous pressure of ≧set •Dialysis wait ○(Continuous) UF stop ○ ― ○ Return to normal by pressing [RESET] SW
MAX ALARM upper alarm limit •Preparation Becoming error free of set upper and lower
•Preparation end DP alarm limits by alarm actuation
•Dialysis
•Recovery
E14 VENOUS PRESSURE MIN Venous pressure of ≦set •Dialysis wait ○(Continuous) UF stop ○ ― ○ Return to normal by pressing [RESET] SW
ALARM lower alarm limit •Preparation Becoming error free of set upper and lower
•Preparation end VP alarm limits by alarm actuation
•Dialysis
•Recovery
E15 ARTERIAL PRESSURE Arterial pressure of •Rinse wait •○(7times) UF stop ○ ― ○ Return to normal by pressing [RESET] SW
MAX LIMIT ≦+400mmHg •Rinse •Same as above
•Rinse end •Same as above
•Air purge •Same as above
•Dialysis wait •○(Continuous)
•Preparation •Same as above
•Preparation end •Same as above
•Dialysis •Same as above
•Recovery •Same as above
E16 ARTERIAL PRESSURE Arterial pressure of •Rinse wait •○(7times) UF stop ○ ― ○ [Return to normal by pressing [RESET] SW
MIN LIMIT ≦-400mmHg •Rinse •Same as above
•Rinse 終了 •Same as above
•Air purge •Same as above
•Dialysis wait •○(Continuous)
•Preparation •Same as above
•Preparation end •Same as above
•Dialysis •Same as above
•Recovery •Same as above

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BP
Alarm Detection Detection Fluid line CLV Alarm
Alarm name Audible alarm SP Resetting and note
No. condition process function close release
stop
E17 ARTERIAL PRESSURE Arterial pressure of ≧set •Dialysis wait ○(Continuous) UF stop ○ ― ○ Return to normal by pressing [RESET] SW
MAX ALARM upper alarm limit •Preparation Becoming error free of set upper and lower
•Preparation end DP alarm limits by alarm actuation
•Dialysis
•Recovery
E18 ARTERIAL PRESSURE Arterial pressure of ≦set •Dialysis wait ○(Continuous) UF stop ○ ― ○ Return to normal by pressing [RESET] SW
MIN ALARM lower alarm limit •Preparation Becoming error free of set upper and lower
•Preparation end DP alarm limits by alarm actuation
•Dialysis
•Recovery
E19 TMP ALARM [VP-DP] of ≧ set alarm •Dialysis ○(Continuous) UF stop ○ ○ ○ Return to normal by pressing [RESET] SW
limit •Recovery
E20 DIALYSATE Dialysate conductivity of Dialysis ○(Continuous) Auto bypass ― ― ― Return to normal by pressing [RESET] SW
CONDUCTIVITY ≧set upper alarm limit Auto reset after release from detection
MAX ALARM condition for 10 sec
E21 DIALYSATE Dialysate conductivity of Dialysis ○(Continuous) Auto bypass ― ― ― Return to normal by pressing [RESET] SW
CONDUCTIVITY MIN ≦set lower alarm limit Auto reset after release from detection
ALARM condition for 10 sec
E22 BLOOD LEAK SENSOR •Detection of absolute •Preparation ○(Continuous) Fluid line stop ― ― ○ Return to normal by pressing [RESET] SW
ERROR blood leak REAL value of •Preparation end
≧ 201 in preparation or •Dialysis
preparation end process •Recovery
•Detection of absolute
blood leak REAL value of
≦ 201 in dialysis or
recovery process
•Signaling of rinse alarm
E23 BLOOD LEAK ALARM Blood leak value of ≧set Dialysis ○(Continuous) UF stop ○ ― ○ Return to normal by pressing [RESET] SW
alarm limit Auto bypass
E24 AIR BUBBLES ARE Bubble detection during •Rinse wait •○(7 times) UF stop ○ ○ ○ Return of UF stop/CLV to normal by
DETECTED ON of BUBBLE [ON/OFF] •Rinse •Same as above SW-OF pressing [RESET] SW
SW •Rinse end •Same as above F Return of BP/SP to normal by SW-ON
•Air purge •Same as above Error detection only when BUBBLE
•Dialysis wait •○(Continuous) [ON/OFF] SW is ON
•Preparation •Same as above
•Preparation end •Same as above
•Dialysis •Same as above
•Recovery •Same as above

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BP
Alarm Detection Detection Fluid line CLV Alarm
Alarm name Audible alarm SP Resetting and note
No. condition process function close release
stop
E25 HEATER OVER HEAT Functioning of "LS1" •Preparation ○(Continuous) Heater OFF ― ― ― Return to normal by pressing [RESET] SW
ALARM placed at heater outside •Preparation end
wall •Dialysis
•Recovery
E26 SHORT WATER SUPPLY Detection of no water •Rinse •○(7times) Fluid line stop ― ― ○ [Return to normal by pressing [RESET] SW
supply pressure by •Preparation •○(Continuous)
pressure SW "PS" •Preparation end •Same as above
•Dialysis •Same as above
•Recovery •Same as above
E27 SHORT DIALYSATE No functioning of "FS" for •Preparation ○(Continuous) ― ― ― ― [Return to normal by pressing [RESET] SW
FLOW 85 sec after chamber •Preparation end
change-over •Dialysis
•Recovery
E28 DIALYSATE FLOW STOP •Functioning of “FS” •Rinse(water •○(7times) Fluid line stop ― ― ― [Return to normal by pressing [RESET] SW
within 20 sec after rinse) •○(Continuous)
chamber change-over •Preparation •Same as above
•Functioning of “FS” for •Preparation end •Same as above
170 sec during dialysis •Dialysis •Same as above
process other than SQHD •Recovery
E29 SN SWITCH TIME ALARM No arrival at changeover Dialysis ○(Continuous) UF stop ○ ○ ○ [Return to normal by pressing [RESET] SW
pressure after set SN Error detection only when SN SW is ON
alarm time
E30 BLOOD PUMP ERROR • Overload •Rinse wait •○(7times) ― ○ ― ― Return to normal by pressing [RESET] SW
• Abnormal rotating •Rinse •Same as above SW-OF Return to normal by BP/SPSW-ON
direction •Rinse end •Same as above F
• Abnormal rotating speed •Air purge •Same as above
•Dialysis wait •○(Continuous)
•Preparation •Same as above
•Preparation end •Same as above
•Dialysis •Same as above
•Recovery •Same as above
E31 BLOOD PUMP STOP • Opening of blood pump Dialysis ○(Continuous) UF stop SPstop ― ― Return to normal by pressing [RESET] SW
ERROR over Auto reset by release from detection
• OFF of blood pump condition
[ON/OFF] SW
• 0 setting of blood pump
flow rate setting volume

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BP
Alarm Detection Detection Fluid line CLV Alarm
Alarm name Audible alarm SP Resetting and note
No. condition process function close release
stop
E32 CLV POSITION ERROR Abnormal clamp position •Rinse wait •○(7times) ― ○ ― ― Return to normal by pressing [RESET] SW
•Rinse •Same as above SW-OF Return to normal by BP/SPSW-ON
•Rinse end •Same as above F
•Air purge •Same as above
•Dialysis wait •○(Continuous)
•Preparation •Same as above
•Preparation end •Same as above
•Dialysis •Same as above
•Recovery •Same as above
E33 VISCOUS PUMP DRIVING Error of viscous pump a •Rinse •○(7times) Fluid line stop ― ― ○ Return to normal by pressing [RESET] SW
ERROR(VPa) •Preparation •○(Continuous)
•Preparation end •Same as above
•Dialysis •Same as above
•Recovery •Same as above
E34 VISCOUS PUMP DRIVING Error of viscous pump b •Rinse •○(7times) Fluid line stop ― ― ○ [Return to normal by pressing [RESET] SW
ERROR(VPb) •Preparation •○(Continuous)
•Preparation end •Same as above
•Dialysis •Same as above
•Recovery •Same as above
E35 VP DRAWING VOLUME Viscous pump operation •Rinse •○(7times) Fluid line stop ― ― ○ Return to normal by pressing [RESET] SW
IS AT MAX LIM. out of allowable range •Preparation •○(Continuous)
•Preparation end •Same as above
•Dialysis •Same as above
•Recovery •Same as above
E36 VPa CLOSED CIRCUIT Insufficient negative Rinse(water ○(7times) ― ― ― ○ Return to normal by pressing [RESET] SW
LEAK ERROR pressure in A chamber rinse) Possible alarm release in maintenance
No arrival at set pressure mode 2
within set time
E37 VPa CLOSED CIRCUIT Fluctuated negative Rinse(water ○(7times) ― ― ― ○ Return to normal by pressing [RESET] SW
LEAK pressure in A chamber rinse) Possible alarm release in maintenance
ERROR Pressure fluctuation out of mode 2
set range during set time
E38 VPb CLOSED CIRCUIT Insufficient negative Rinse(water ○(7times) ― ― ― ○ Return to normal by pressing [RESET] SW
LEAK pressure in B chamber rinse) Possible alarm release in maintenance
ERROR No arrival at set pressure mode 2
within set time
E39 VPb CLOSED CIRCUIT Fluctuated negative Rinse(water ○(7times) ― ― ― ○ Return to normal by pressing [RESET] SW
LEAK pressure in B chamber rinse) Possible alarm release in maintenance
ERROR Pressure fluctuation out of mode 2
set range during set time

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BP
Alarm Detection Detection Fluid line CLV Alarm
Alarm name Audible alarm SP Resetting and note
No. condition process function close release
stop
E40 VPa CLOSED CIRCUIT Insufficient positive Rinse(water ○(7times) ― ― ― ○ Return to normal by pressing [RESET] SW
LEAK ERROR pressure in A chamber rinse) Possible alarm release in maintenance
No arrival at set pressure mode 2
within set time
E41 VPa CLOSED CIRCUIT Fluctuated positive Rinse(water ○(7times) ― ― ― ○ Return to normal by pressing [RESET] SW
LEAK ERROR pressure in A chamber rinse) Possible alarm release in maintenance
Pressure fluctuation out of mode 2
set range during set time
E42 VPb CLOSED CIRCUIT Insufficient positive Rinse(water ○(7times) ― ― ― ○ Return to normal by pressing [RESET] SW
LEAK ERROR pressure in B chamber rinse) Possible alarm release in maintenance
No arrival at set pressure mode 2
within set time
E43 VPb CLOSED CIRCUIT Fluctuated positive Rinse(water ○(7times) ― ― ― ○ Return to normal by pressing [RESET] SW
LEAK ERROR pressure in B chamber rinse) Possible alarm release in maintenance
Pressure fluctuation out of mode 2
set range during set time
E44 AIR ELIMINATION TANK Functioning of "FSW" of •Rinse •○(7 times) •― ― ― ○ Return to normal by pressing [RESET] SW
ERROR air elimination tank for ≧ •Preparation •○(Continuous) •Same as above
15 sec in dialysis process •Preparation end •Same as above •Same as above
or for ≧ 30 sec in any •Dialysis •Same as above •Fluid line stop
process other than •Recovery •Same as above •―
dialysis
E45 BLOWN-OUT FUSE Blown out of pump fuse •Rinse wait •○(7times) Fluid line stop ― ― ― Return to normal by pressing [RESET] SW
DETECTION •Rinse •Same as above
•Rinse end •Same as above
•Air purge •Same as above
•Dialysis wait •○(Continuous)
•Preparation •Same as above
•Preparation end •Same as above
•Dialysis •Same as above
•Recovery •Same as above
E46 WATCH-DOG ERROR System resetting after •Rinse wait •○(7times) ― ― ― ― Return to normal by pressing [RESET] SW
system error detection by •Rinse •Same as above RAM initialization after error detection
watch dog •Rinse end •Same as above
•Air purge •Same as above
•Dialysis wait •○(Continuous)
•Preparation •Same as above
•Preparation end •Same as above
•Dialysis •Same as above
•Recovery •Same as above

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BP
Alarm Detection Detection Fluid line CLV Alarm
Alarm name Audible alarm SP Resetting and note
No. condition process function close release
stop
E47 RAM ERROR RAM error •Rinse wait •○(7times) ― ― ― ― Return to normal by pressing [RESET] SW
•Rinse •Same as above Error detection only when power SW is ON
•Rinse end •Same as above or power failure is corrected
•Air purge •Same as above RAM initialization after error detection
•Dialysis wait •○(Continuous)
•Preparation •Same as above
•Preparation end •Same as above
•Dialysis •Same as above
•Recovery •Same as above
E48 EEPROM ERROR EEPROM error •Rinse wait •○(7times) ― ― ― ― Return to normal by pressing [RESET] SW
•Rinse •Same as above Error detection only when power SW is ON
•Rinse end •Same as above or power failure is corrected
•Air purge •Same as above
•Dialysis wait •○(Continuous)
•Preparation •Same as above
•Preparation end •Same as above
•Dialysis •Same as above
•Recovery •Same as above
E49 EPROM ERROR EPROM error •Rinse wait •○(7times) ― ― ― ― Return to normal by pressing [RESET] SW
•Rinse •Same as above Error detection only when power SW is ON
•Rinse end •Same as above or power failure is corrected
•Air purge •Same as above RAM initialization after error detection
•Dialysis wait •○(Continuous)
•Preparation •Same as above
•Preparation end •Same as above
•Dialysis •Same as above
•Recovery •Same as above
E50 RAM INITIALIZE RAM initialization •Rinse wait •○(7times) ― ― ― ― Return to normal by pressing [RESET] SW
•Rinse •Same as above Error detection only when power SW is ON
•Rinse end •Same as above or power failure is corrected
•Air purge •Same as above Auto shift to dialysis wait process after
•Dialysis wait •○(Continuous) error detection
•Preparation •Same as above
•Preparation end •Same as above
•Dialysis •Same as above
•Recovery •Same as above

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BP
Alarm Detection Detection Fluid line CLV Alarm
Alarm name Audible alarm SP Resetting and note
No. condition process function close release
stop
E51 EEPROM INITIALIZE EEPROM initialization •Rinse wait •○(7times) ― ― ― ― Return to normal by pressing [RESET] SW
•Rinse •Same as above Error detection only when power SW is ON
•Rinse end •Same as above or power failure is corrected
•Air purge •Same as above Auto shift to dialysis wait process after
•Dialysis wait •○(Continuous) error detection
•Preparation •Same as above
•Preparation end •Same as above
•Dialysis •Same as above
•Recovery •Same as above
E52 SWITCH ERROR ON of any SW on •Rinse wait •○(7times) ― ― ― ― Return to normal by pressing [RESET] SW
operation panel for 30 sec •Rinse •Same as above
continuously at power SW •Rinse end •Same as above
ON •Air purge •Same as above
•Dialysis wait •○(Continuous)
•Preparation •Same as above
•Preparation end •Same as above
•Dialysis •Same as above
•Recovery •Same as above
E53 I/O PORT ERROR Error of I/O port on board •Rinse wait •○(7times) Fluid line stop ○ ― ― Return to normal by power SW ON
•Rinse •Same as above Disabled all functions of the machine and
•Rinse end •Same as above components on operation panel after error
•Air purge •Same as above detection
•Dialysis wait •○(Continuous)
•Preparation •Same as above
•Preparation end •Same as above
•Dialysis •Same as above
•Recovery •Same as above
E54 CONNECTION ERROR Disconnection of harness •Rinse wait •○(7times) Fluid line stop ○ ― ― Return to normal by power SW ON
SBY0151-SBY0156 used to connect main •Rinse •Same as above Disabled all functions of the machine and
board to operation board •Rinse end •Same as above components on operation panel after error
•Air purge •Same as above detection
•Dialysis wait •○(Continuous)
•Preparation •Same as above
•Preparation end •Same as above
•Dialysis •Same as above
•Recovery •Same as above

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BP
Alarm Detection Detection Fluid line CLV Alarm
Alarm name Audible alarm SP Resetting and note
No. condition process function close release
stop
E55 BP BATTERY ERROR BP backup battery voltage •Rinse wait •○(7times) ― ― ― ○ Return to normal by pressing [RESET] SW
of ≦8.5V •Rinse •Same as above Possible alarm release in maintenance
•Rinse end •Same as above mode 7
•Air purge •Same as above
•Dialysis wait •○(Continuous)
•Preparation •Same as above
•Preparation end •Same as above
•Dialysis •Same as above
•Recovery •Same as above
E56 COUPLER SW ON "LS2" ON Dialysis ○(Continuous) Fluid line stop ― ― ― Return to normal by pressing [RESET] SW
ALARM (DIALYSIS)
E57 COUPLER SW ON Pressing [UF DIALYSE] •Preparation end ○(3 times) ― ― ― ― Return to normal by pressing [RESET] SW
ALARM (PREP.) SW during "LS2" is ON •Recovery Auto reset by release from detection
condition
E58 COUPLER SW OFF "LS2" OFF Rinse ○(3 times) Fluid line stop ― ― ― Return to normal by pressing [RESET] SW
ALARM Auto reset by release from detection
condition
E59 UF MAX ALARM BP flow rate/UFR relation Dialysis ○(Continuous) UF stop ― ― ― Return to normal by pressing [RESET] SW
of ≧set upper UFR alarm Auto reset by release from detection
limit condition
E60 SYRINGE INFUSION Syringe pump SW ON; and •Rinse wait •○(7times) ― SP stop ― ― Return to normal by pressing [RESET] SW
COMPLETION detection of the pump •Rinse •Same as above Auto reset by release from detection
over-load signal "LS3" •Rinse end •Same as above condition
•Air purge •Same as above Error detection when SP SW is ON
•Dialysis wait •○(Continuous)
•Preparation •Same as above
•Preparation end •Same as above
•Dialysis •Same as above
•Recovery •Same as above
E61 COMPLETION OF Arrival at preset syringe Dialysis ○(3 times) ― SP stop ― ― Return to normal by pressing [RESET] SW
SYRINGE.P INFUSION operation stop time Auto reset by release from detection
condition
E62 PERFORMED PRIMING Priming completion with Priming ○(3 times) ― BP stop ○ ― Return to normal by pressing [RESET] SW
preset solution volume SW-OF Auto reset by release from detection
F condition
E63 PREFORMED TARGET Achievement of target UF Dialysis ○(Continuous) UF stop ― ― ― Return to normal by pressing [RESET] SW
UF. volume Auto reset by release from detection
condition
Becoming error free of set upper and lower
VP/DP alarm limits by alarm actuation

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BP
Alarm Detection Detection Fluid line CLV Alarm
Alarm name Audible alarm SP Resetting and note
No. condition process function close release
stop
E64 NO WATER RINSING Shift to dialysis wait Dialysis wait ○(3 times) ― ― ― ― Return to normal by pressing [RESET] SW
process without executing Return to normal by water rinsing for
water rinse for specified specified time
time after
disinfection/rinse, acid
rinse, hot water rinse or
hot chemical disinfectant
rinse.
E65 PREPARE DIALYSATE Detection of no pressure Preparation ○(Continuous) Fluid line stop ― ― ― Return to normal by pressing [RESET] SW
CONC. rise in A or B concentrate
line by "PS" and detection
of no connection of the
line to the machine
E66 CONC CONNECTOR TO Detection of pressure rise Rinse ○ (3 times) Fluid line stop ― ― ― Return to normal by pressing [RESET] SW
RINSING PORT. in A or B concentrate line Preparation ○ (continuour)
by "PS" and detection of
no connection of the line
to rinse port
E67 RESET SW No press of [RESET] SW •Dialysis wait ○(Continuous) ― ― ― ○ Return to normal by pressing [RESET] SW
for set time after alarm •Preparation Possible alarm release in maintenance
actuation •Preparation end mode 2
•Dialysis
•Recovery
E68 UF DIALYSE SW No press of [UF DIALYSE] Preparation end ○(3 times) ― ― ― ○ Return to normal by pressing [RESET] SW
SW for set time Possible alarm release in maintenance
mode 2
E69 BYPASS SW No release from manual Dialysis ○(3 times) ― ― ― ○ Return to normal by pressing [RESET] SW
ON of [BYPASS] SW Possible alarm release in maintenance
within set time mode 2

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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.

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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.

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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.

[MAINTE MENU(4/5)]
MODE7:SYSTEM
MODE8:SERVICE FREQUENCY
MODE7 MODE8 P.UP P.DOWN DISP.

F・1 F・2 F・3 F・4 F・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.

[MAINTE 7]
4.DISINFECTION RATIO :1/300
5.ACID RATIO : 1/30
+ - UP DOWN MENU

F・1 F・2 F・3 F・4 F・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.

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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.

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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.

[MAINTE MENU(4/5)]
MODE7:SYSTEM
MODE8:SERVICE FREQUENCY
MODE7 MODE8 P.UP P.DOWN DISP.

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.

[MAINTE 7]
5.ACID RATIO : 1/30
6.HOT DISINFECTION RATIO : 1/26
+ - UP DOWN MENU

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. The 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.

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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
[DIALYSIS]SW_ON
透析待機工程
Dialysis wait 洗Rinse
浄待機工程wait エア抜き工程
Air purge

[PRIP.]SW_ON [RINSE]SW_ON

準備工程
Preparation 洗浄工程
Rinse

自動 洗浄終了

Preparation
準備完了工程 洗浄終了工程
Rinse end
end

[UF DIALYSE]SW_ON

透析工程
Dialysis

[PREP.]SW_ON [UF DIALYSE]SW_ON

R回収工程
ecovery

Fig. 12-1 Process flow

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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.

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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.

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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℃. □OK □NG

・ Relative humidity should be 35~80%. □OK □NG

・ Atmospheric pressure should be 795~1062hPa. □OK □NG

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


10cm from each of right and left sides of it and ≧20cm
from rear side of it.
□OK □NG
・ Ventilation port of ≧φ20cm should be provided or at
least one side other than the machine bottom should be
exposed to atmosphere.

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No. Item to be checked Paint out □
2 Fluid supply and drainage
・ All tubes and lines such as supply and drain tubes □OK □NG
should be free from damages such as folding and
bending.
□OK □NG
・ Water supply pressure should be 0.049 ~ 0.74MPa (0.5 ~
7.5kgf/cm2) □OK □NG

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

・ Supply water temperature should be 17~30℃.


(If heat exchanger is used, it should be 5~30℃.) □OK □NG

・ Water quality should be suitable for dialysis use. □OK □NG

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


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

・ Drain tube end should not be contacted with waste water


level.
3 Power supply
・ Rating of power supply should conform to that of the □OK □NG
machine.
□OK NG
・ Capacity of power supply should exceed that of the
machine.
4 Ground connection and equipotentialization
・ Power supply should be provided with protective ground □OK □NG
terminal.

・ Protective ground conductors of power cord and power □OK □NG


plug should be connected correctly.

5 Connection of power supply


・ Power cord plug of the machine should be connected to □OK □NG
receptacle of power supply correctly.

6 Cleaning
・ The machine enclosure should be cleaned. □ OK □NG

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No. Item to be checked Paint out □
7 Residual disinfectant
・ Residual disinfectant should not be detected by testing □OK □NG
drain water using reagent or test paper.

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

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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.

SINGLE PATIENT DIALYSIS MACHINE


SURDIAL TYPE Ⅱ
NIPRO CORPORATION RAM:OK
ROM Ver.3.00/04 ROM:OK

F・1 F・2 F・3 F・4 F・5

NOTE
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.

[RINSE MENU]
RINSE1:WATER RINSE3:AUTO1 C&D
RINSE2:CHEMICAL RINSE4:AUTO2 C&D
RINSE1 RINSE2 RINSE3 RINSE4 DISP.

F・1 F・2 F・3 F・4 F・5

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

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

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13.2.3 Dialysis
(1) Check OFF of [DIALYSIS] SW lamp.
(2) Press [DIALYSIS] SW.
z [DIALYSIS] SW lamp is OFF.
z Dialysis screen is displayed.

[DIALYSIS]
VP: 0mmHg DP: 5mmHg COND: 0.0mS/cm
AP: 0mmHg TMP: -5mmHg TEMP:20.0゜C
S.N. SQHD PRIM TEST DISP.

F・1 F・2 F・3 F・4 F・5

(3) Follow the procedures specified in Chapter 15 or 16 to execute dialysis.

13.2.4 Postrinse
(1) Check ON of [DIALYSIS] SW lamp.
(2) Press [DIALYSIS] SW.
z [DIALYSIS] SW lamp is OFF.
z Rinse menu screen is displayed.

[RINSE MENU]
RINSE1:WATER RINSE3:AUTO1 C&D
RINSE2:CHEMICAL RINSE4:AUTO2 C&D
RINSE1 RINSE2 RINSE3 RINSE4 DISP.

F・1 F・2 F・3 F・4 F・5

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

CAUTION
z Rinse the machine after dialysis termination to prevent cross infection among patients,
z Rinse the machine after disconnection of patient from it.

13.2.5 Machine power breaker OFF


(1) When postrinsing is completed, press [DIALYSIS] SW to display dialysis screen.
(2) Turn off power breaker placed at rear side of the machine.
z Power lamp is OFF.
z Information on operation panel is OFF.

NOTE
z The machine can be left under power breaker OFF until the next dialysis. It is
recommended, however, to turn off the breaker when the machine is not operated for long
time.

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Chapter 14

RINSING
1. Select rinsing mode.
2. Set rinsing pattern.
3. Connect concentrate line(s) to the machine.
4. Start rinsing operation.
5. Terminate rinsing operation.
6. Discontinue rinsing operation.

WARNING
z Execute rinsing operation before and after dialysis.
z To execute disinfection/rinse or acid rinse, read Chapter 11.
z Read optional manual before use of hot water rinse or hot chemical disinfectant rinse.
z Do not apply hot rinse without hot rinse option. It might cause breakdown of the machine.

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14.1 Selection of rinsing mode
(1) Check that rinse menu screen is displayed.
(2) Press [F・1], [F・2], [F・3] or [F・4] SW to select rinsing mode in rinse menu screen.

[RINSE MENU]
RINSE1:WATER RINSE3:AUTO1 C&D
RINSE2:CHEMICAL RINSE4:AUTO2 C&D
RINSE1 RINSE2 RINSE3 RINSE4 DISP.

F・1 F・2 F・3 F・4 F・5

zRINSE1(WATER) :Execution of water rinsing for specified time


zRINSE2(CAHEMICAL):Execution of disinfection/rinsing for specified time
zRINSE3(AUTO1 C&D) :Execution of set rinsing pattern for set time
Also possible program setting of prerinse start time
zRINSE4(AUTO2 C&D) :Same as the case of RINSE3(AUTO1 C&D)

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


(1) Check whether rinse mode is same as selected one.
zCurrent time is displayed at position next to title.
(2) Press [F・3] or [F・4] SW to shift blink to position for the setting is changed.
(3) Press [F・1] or [F・2] SW to change set value.
(4) Check whether the setting is correct.

[RINSE4] 20:15 < Wait >


WTR30→CHM30→DWL30→PRE30→-----→-----
PRERINSE START TOMORROW 10:00
+ - < > MENU

F・1 F・2 F・3 F・4 F・5

zWTR※※ :Execution of water rinsing for ※※ min


zCHM※※ :Execution of disinfection/rinse for ※※ min
zACD※※ :Execution of acid rinsing for ※※ min
zDEL※※ :Execution of dwelling for ※※ min
zPRE※※ :Execution of prerinsing at set time
z----- :No execution
zPRERINSE START :Setting of prerinse start time

NOTE
z When RINSE1 or RINSE2 is selected, only rinsing time can be set.
z When acid rinse port unit (option) is not used, simultaneous setting of both
disinfection/rinsing and acid rinsing in RINSE3 or RINSE4 mode is disabled.
z Refer to the option manual for setting. Set up hot water rinse (HWR) and hot chemical
disinfectant rinse (HCM) already have hot rinse option.

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14.3 Connection of concentrates

CAUTION
z Connect each concentrate connector and rinse port securely. If not so, troubles such as
water leak and air aspiration may be caused.
z Concentrate type(s) and concentrate connector type(s) are defined by use or no use of
acid rinse port unit (option) and rinse mode to be executed. Take care of this when
connection is executed.
z Use disinfectant and acetic acid concentrates of specified concentrations.

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

WARNING
z When acid rinse port (option) is not used, aspiration port of disinfectant or acetic acid
concentrate can be used as connector of disinfectant concentrate container. Check
conformance of concentrate type to rinse mode to be executed.

14.3.1.1 Connection at water rinse


(1) Connection of any concentrate is not required. Connect all concentrate connectors to
respective rinse ports or engage them with connector receivers.
(2) Check correct connector connection.

14.3.1.2 Connection at disinfection/rinse


(1) Connect disinfectant concentrate connector placed at rear side of the machine to
disinfectant concentrate container.
(2) Connect other connectors to respective rinse ports or engage them with connector
receivers.
(3) Check correct connector connection.

14.3.1.3 Connection at acid rinse


(1) Connect disinfectant concentrate connector placed at rear side of the machine to acetic
acid concentrate container.
(2) Connect other connectors to respective rinse ports or engage them with connector
receivers.
(3) Check correct connector connection.

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

WARNING
z When acid rinse port unit (option) is used, aspiration ports of disinfectant and acetic acid
concentrates can be used as connectors of concentrates to be used. Check conformance
of connector types to rinsing mode to be executed.

14.3.2.1 Connection at water rinse


(1) Connection of any concentrate is not required. Connect all concentrate connectors to
respective rinse ports or engage them with respective connector receivers.
(2) Check correct connector connection.

14.3.2.2 Connection at disinfection/rinse


(1) Connect disinfectant concentrate connector placed at rear side of the machine to
disinfectant concentrate container.
(2) Connect other connectors to respective rinse ports or engage them with respective
connector receivers.
(3) Check correct connector connection.

14.3.2.3 Connection at acid rinse


(1) Connect acetic acid concentrate connector placed at rear side of the machine to acetic
acid concentrate container.
(2) Connect other connectors to respective rinse ports or engage them with respective
connector receivers.
(3) Check correct connector connection.

14.3.2.4 Connection at auto rinse 1 or 2


(1) Connect disinfectant concentrate connector placed at rear side of the machine to
disinfectant concentrate container.
(2) Connect acetic acid concentrate connector placed at rear side of the machine to acetic
acid concentrate container.
(3) Connect other connectors to respective rinse ports or engage them with respective
connector receivers.
(4) Check correct connector connection.

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14.4 Start of rinsing (example: RINSE4(AUTO2 C&D))
(5) Check rinsing pattern.
(6) Check concentrate connection.
(7) Press [RINSE] SW.
z[RINSE] SW lamp is ON.
zRinsing is started.
zRinsing progress is displayed in screen.

[RINSE4] 21:00 < Rinse >


WTR00→CHM15→DWL30→PRE30
PRERINSE START TOMORROW 10:00
DISP.

F・1 F・2 F・3 F・4 F・5

NOTE
z When rinsing pattern to execute disinfection/rinsing and acid rinsing in sequence is set
after selecting RINSE3 or RINSE4 mode, execution of the pattern is disabled even by
pressing [RINSE] SW.
z When rinsing pattern not to execute water rinse or prerinse next to other rinsing
operation is set after selecting RINSE3 or RINSE4 mode, execution of the pattern is
disabled even by pressing [RINSE] SW.

14.5 Completion of rinsing


(1) Check completion of all rinsing steps.

[RINSE4] 10:40 < End >


WTR00→CHM00→DWL00→PRE00
PRERINSE START TODAY 10:00
DISP.

F・1 F・2 F・3 F・4 F・5

(2) Connect all concentrate connectors to respective rinse ports or engage them with
respective connector receivers.
(3) Check correct connector connection.
(4) Press [DIALYSIS] SW.
z[RINSE] SW is OFF.
z[DIALYSIS] SW lamp is ON.
zDialysis screen is displayed.

[DIALYSIS]
VP: 0mmHg DP: 5mmHg COND: 0.0mS/cm
AP: 0mmHg TMP: -5mmHg TEMP:20.0゜C
S.N. SQHD PRIM TEST DISP.

F・1 F・2 F・3 F・4 F・5

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14.6 Discontinuance of rinsing
(1) Press [DIALYSIS] SW.
z[RINSE] SW lamp is OFF.
z[DIALYSIS] SW lamp is ON.
zDialysis screen is displayed.

WARNING
z Rinsing can be discontinued at any step during the operation.
z DO NOT execute dialysis after rinsing is discontinued. Disinfectant or acid may be left in
the machine. Rinse the machine again to execute sialysis.

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Chapter 15

DOUBLE NEEDLE DIALYSIS

1. Set dialysis related parameters.


2. Connect concentrate(s) to the machine.
3. Set blood line, dialyzer and syringe to the machine.
4. Start preparation process of the machine (preparation process)..
5. Check preparation completion of the machine (preparation end process).
6. Execute priming operation.
7. Check dialysate conductivity.
8. Set UF related parameters.
9. Connect patient to the machine.
10. Start dialysis (dialysis process).
11. Terminate dialysis (recovery process)..
12. Discontinue dialysis (recovery process).

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15.1. Setting of dialysate related parameters

1. Set dialysis mode.


2. Set dialysate concentration.
3. Set dialysate temperature

15.1.1. Setting of dialysis mode


(1) Press [F・5] SW to display settingⅡscreen.
(2) Press [F・3] or [F・4] SW to blink "4.MODE".
(3) Press [F・1] or [F・2] SW to change setting.
(4) Check correct setting.

[SETTING2]
1.BC(W+A+B) :140 2.BC(W+A) :110
3.AC(W+AC) :140 4.MODE :BC1
+ - < > DISP.

F・1 F・2 F・3 F・4 F・5

zBC1(BICARBONATE1) :Execution of bicarbonate dialysis


zBC2(BICARBONATE2) :Execution of bicarbonate dialysis
zAC(ACETATE) :Execution of acetate dialysis

WARNING
z Information concerning concentrate for each of BC1, BC2 and AC is found in
maintenance mode 5 screen. Set dialysis mode conforming to concentrate(s) intended to
be used.
z Both BC1 and BC2 are bicarbonate dialysis. Information not related to concentrate(s)
intended to be used may be shown in maintenance mode 5 screen. Take care of this.

15.1.2. Setting of dialysate concentration


15.1.2.1. Bicarbonate dialysate
(1) Press [F・5] SW to display settingⅡscreen.
(2) Press [F・3] or [F・4] SW to blink "1.BC(W+A+B)".
(3) Press [F・1] or [F・2] SW to change setting.
(4) Press [F・3] or [F・4] SW to blink "2.BC(W+A)".
(5) Press [F・1] or [F・2] SW to change setting.
(6) Check correct setting.

[SETTING2]
1.BC(W+A+B) :140 2.BC(W+A) :110
3.AC(W+AC) :140 4.MODE :BC1
+ - < > DISP.

F・1 F・2 F・3 F・4 F・5

z1.BC(W+A+B) :Setting of final concentration of bicarbonate dialysate by mmol/l unit


z 2.BC(W+A) Setting of concentration of [water + A concentrate] in
bicarbonate dialysate by mmol/l unit
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15.1.2.2. Acetate dialysate
(1) Press [F・5] SW to display settingⅡscreen.
(2) Press [F・3] or [F・4] SW to blink "3.AC(W+AC)".
(3) Press [F・1] or [F・2] SW to change setting.
(4) Check correct setting.

[SETTING2]
1.BC(W+A+B) :140 2.BC(W+A) :110
3.AC(W+AC) :140 4.MODE :BC1
+ - < > DISP.

F・1 F・2 F・3 F・4 F・5

z3.AC(W+AC) :Setting of final concentration of acetate dialysate by mmol/l unit

15.1.3. Setting of dialysate temperature


(1) Press [F・5] SW to display settingⅠscreen.
(2) Press [F・3] or [F・4] SW to blink "1.TEMP(℃)".
(3) Press [F・1] or [F・2] SW to change setting.
(4) Check correct setting.

[SETTING1]
1.TEMP (°C):37.0 2.BAR GRAPH :DP
3.S.STP(min): 0 4.BOLUS (ml):0.0
+ - < > DISP.

F・1 F・2 F・3 F・4 F・5

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15.2. Connection of concentrates

CAUTION
z Connect each concentrate connector and rinse port securely to prevent troubles such as
water leak and air aspiration.
z Use A and B concentrates for preparing bicarbonate dialysate and acetic acid
concentrate for preparring acetate dialysate of specified concentrations.

15.2.1. Connection of concentrates to prepare bicarbonate dialysate


(1) A concentrate line connector is connected to rinse port. Disconnect the line connector
from the port by pulling the line connector under moving ring of the port to this side.
(2) Full push the disconnected connector against A concentrate container connector until
click is heard.
(3) Bconcentrate line connector is connected to rinse port. Disconnect the line connector
from the port by pulling the line connector under moving ring of the port to this side.
(4) Full push the disconnected connector against B concentrate container connector until
click is heard.
(5) Connect other concentrate line connectors to respective rinse ports or engage them
with respective connector receivers.
(6) Check correct connector connection.

15.2.2. Connection of concentrate to prepare acetate dialysate


(1) A concentrate line connector is connected to rinse port. Disconnect the connector from
the port by pulling the connector under moving ring of the port to this side.
(2) Full push the disconnected connector against A concentrate container connector until
click is heard.
(3) Connect other concentrate line connectors to respective rinse ports or engage them
with respective connector receivers.
(4) Check correct connector connection.

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15.3. Setting of blood line, dialyzer and syringe

1. Set blood line to the machine.


2. Set dialyzer to the machine.
3. Set syringe to syringe pump.
4. Setting of syringe pump

15.3.1. Setting of blood line


(1) Prepare blood line authorized by us or the equivalent.
(2) Check no damage of the line.
(3) Close clamp on level adjusting line in arterial side and that on arterial pressure monitor
line followed by setting arterial drip chamber to holder.
(4) When arterial pressure sensor (option) is used, connect the pressure monitor line to
pressure inlet of arterial pressure sensor under care of no line folding and/or twisting.
(5) Open blood pump cover.
(6) Load rolling tube in arterial line to blood pump. Insert the tube in space between the
pump rotor and housing and rotate the pump clockwise manually.
(7) Close the pump cover.
(8) Close clamp on level adjusting line in venous side and that on venous pressure monitor
line followed by setting venous drip chamber to holder.
(9) Connect the monitor line to pressure inlet of venous pressure sensor under care of no
line folding and/or twisting.
(10) Load bubble detector to main venous tube by holding top and bottom of the detector by
fingers.
(11) Load clamp to main venous tube.

15.3.2. Setting of dialyzer


(1) Set dialyzer to holder under directing venous side (blue) upward.
(2) Connect arterial line to arterial port (red) of dialyzer.
(3) Connect venous line to venous port (blue) of dialyzer.

15.3.3. Setting of syringe


(1) Remove air from fluid drug contained in syringe by advancing plunger.
(2) Shift pusher of syringe pump to the right end under pressing it.
(3) Set syringe to holder of the pump so that syringe plunger is received in slit of the
pusher.
(4) Fix syringe by turning syringe holding lever.

15.3.4. Setting of syringe pump


15.3.4.1. Setting of cross-section ratio of syringe
Calculate ratio of cross-sectional area of syringe intended to be used to that of Nipro 20ml
syringe (292.5mm2) as 100% and set the ratio.
When the set ratio is 50%, pusher moves at a doubled speed compared with the case that

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the ratio is 100% with exception that the speed is defined in the case of bolus infusion.

When the set ratio is 200%, it moves at a half speed compared with the case that the ratio is
100% with the exception.

(1) Press [F・5] SW to display maintenance mode 7 screen.


(2) Press [F・3] or [F・4] SW to indicate "20.MAINTENANCE MODE FREE".

[MAINTE 7]
20.MAINTENANCE MODE FREE : OFF

UP DOWN MENU

F・1 F・2 F・3 F・4 F・5

(3) Press [F・1] SW to set to "ON".

[MAINTE 7]
20.MAINTENANCE MODE FREE : ON

+ - UP DOWN MENU

F・1 F・2 F・3 F・4 F・5

(4) Instruction appears in [F・1] or [F・2] SW (+/-). Check that setting is enabled by
blinking of items to be set.
(5) Press [F・3] or [F・4] SW to blink "1.SYRINGE RATE".
(6) Press [F・1] or [F・2] SW to change set value.

[MAINTE 7]
1.SYRINGE RATE : 100
2.BP STOP AFTER POWER FAIL : OFF
+ - UP DOWN MENU

F・1 F・2 F・3 F・4 F・5

(7) Press [F・3] or [F・4] SW to indicate "20.MAINTENANCE MODE FREE".


(8) Press [F・1] SW to set to "OFF".
(9) Setting of syringe operation stop time

By the setting, automatic syringe operation stop is enabled at a set time before UF
completion and the stop is indicated by error message "E61 COMPLETION OF SYRINGE.P
INFUSION".

(1) Press [F・5] SW to display settingⅠscreen.


(2) Press [F・3] or [F・4] SW to blink "3.S.STP(min)".
(3) Press [F・1] or [F・2] SW to change set value.
(4) Check the changed set value.

[SETTING1]
1.TEMP (°C):37.0 2.BAR GRAPH :DP
3.S.STP(min): 0 4.BOLUS (ml):0.0
+ - < > DISP.

F・1 F・2 F・3 F・4 F・5

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15.3.4.2. Setting of syringe operation stop time
By the setting, automatic syringe operation stop is enabled at a set time before UF
completion and the stop is indicated by error message "E61 COMPLETION OF SYRINGE.P
INFUSION".

(1) Press [F・5] SW to display settingⅠscreen.


(2) Press [F・3] or [F・4] SW to blink "3.S.STP(min)".
(3) Press [F・1] or [F・2] SW to change set value.
(4) Check the changed set value.

[SETTING1]
1.TEMP (°C):37.0 2.BAR GRAPH :DP
3.S.STP(min): 0 4.BOLUS (ml):0.0
+ - < > DISP.

F・1 F・2 F・3 F・4 F・5

15.3.4.3. Setting of fast-forward volume


By pressing [F.F.] SW during syringe pump operation, pusher moves at fast forward speed.
Pusher moves a specified speed to perform bolus infusion followed by automatic returning
to the
normal infusion after infusing a set infusate volume.

(1) Press [F・5] SW to display setting screen.


(2) Press [F・3] or [F・4] SW to blink "4.BOLUS(ml)".
(3) Press [F・1] or [F・2] SW to change set value.
(4) Check the changed set value.

[SETTING1]
1.TEMP (°C):37.0 2.BAR GRAPH :DP
3.S.STP(min): 0 4.BOLUS (ml):0.0
+ - < > DISP.

F・1 F・2 F・3 F・4 F・5

z0.0 :Bolus infusion during pressing [F.F] SW only until reaching to maximum
infusion
as 5 mL. Return regular infusion automatically when bolus infusion is
reached to
maximum infusion.
z0.5-5.0 :Bolus infusion of set infusate volume

CAUTION
z Syringe pump may not stop infusing after releasing [F.F] SW by some switch
malfunction. In this case, stop syringe pump by turn OFF the breaker of the machine and
then interrupt treatment. Machine must be disconnected from patient.

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15.4. Preparation of machine (preparation process)
(1) Press [F・5] SW to display dialysis screen.
(2) Press [PREP.] SW once.
z[PREP.] SW lamp is flashing.
z[BYPASS] SW lamp is flashing.
zDialysate preparation is started.

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


(1) Check that [PREP.] SW lamp is ON.
(2) Check that [BYPASS] SW lamp is OFF.
(3) Check normal operation of the machine.

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15.6. Priming process

CAUTION
z Follow instruction of dialyzer manufacturer to know “which should be preceded blood or
dialysate compartment when dialyzer is primed”.
z In the case of priming blood compartment, when “priming function” is used, follow
instruction specified in 15.6.4.1. If the function is not used, follow instruction specified in
15.6.4.2.
z Priming method may be specified by each hospital or medical facilities. Prime dialyzer
based on method specified by it unless function and performance of the machine is
damaged. The method described in this manual is example.

1. Set saline vial to hanger.


2. Prime blood line with saline.
3. Prime dialysate compartment of dialyzer with dialysate.
4. Rinse blood line and blood compartment of dialyzer.

15.6.1. Setting of saline vial


(1) Set saline vial to hanger.
(2) Fill drip chamber of saline infusion set with saline until level in the chamber arrives at
1/2 to 3/4 of full height of it.
(3) Clamp saline line of arterial side.
(4) Connect the line to the infusion set.

15.6.2. Priming of saline


(1) After checking that level adjusting line of arterial side is clamped and that arterial shunt
joint line is not clamped, open clamp of saline line.
Rinse the shunt joint line with required volume of saline by gravity flow.
(2) Close clamp of the joint line to stop saline flow.
(3) Rinse syringe infusion line.
・ Remove Luer cap from the line and put in waste container.
・ Open clamp of the line.
・ Open blood pump cover.
・ Rinse the line with required volume of saline by turning blood pump rotor clockwise
manually under closing dialyzer side of blood line.
・ Close blood pump cover.
・ Close clamp of the infusion line.
・ Connect the line to syringe set to syringe pump.
・ Open clamp of the line.
(4) After checking that level adjusting line of venous side is clamped and venous shunt
joint line is not clamped, turn on [ON/OFF] SW of blood pump to operate it with flow rate
indication.

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(5) Set flow rate by operating flow rate setting volume of blood pump.
(6) Adjust level in arterial drip chamber.
・ Check that clamp of level adjusting line is closed.
・ Open cap of the line to connect syringe.
・ Remove clamp and adjust level in arterial drip chamber to desired height by pushing
or pulling syringe plunger.
・ Close clamp of the line.
(7) After venous tube is primed with saline up to its distal end, turn off [ON/OFF] SW of
blood pump to stop it without flow rate indication.

15.6.3. Priming of dialyzer with dialysate


(1) Turnover dialyzer to direct arterial port (red) upward.
(2) Turn on [BYPASS] SW to enable bypass mode. [BYPASS] SW lamp is ON.
(3) Set coupler to dialyzer and place intermediate connector of the coupler on coupler
receiver.
(4) Turn off [BYPASS] SW to release bypass mode. [BYPASS] SW lamp is OFF.
(5) Check air removal from dialyzer.
(6) Turnover dialyzer to direct venous port (blue) upward.

15.6.4. Rinsing of blood line and dialyzer


15.6.4.1. When priming function is used
(1) Press [F・5] SW to display dialysis screen.
(2) Press [F・3] SW to display priming screen.

[PRIMING]
SOLUTION VOL.(l):5.00
ACCUMULATED VOL.(l):5.00 RATIO(%):100
+ - EXIT DISP.

F・1 F・2 F・3 F・4 F・5

(3) Press [F・1] or [F・2] SW to set "SOLUTION VOL.(l)" to suitable level so that small
amount of saline can be left in vial after priming completion.
(4) Check that "ACCUMULATED VOL.(l)" is 0.00.
(5) Check that "RATIO(%)" is 0.
(6) Set flow rate by operating flow rate adjusting volume of blood pump.
(7) Turn on [ON/OFF] SW of blood pump to operate it.
(8) Remove air from dialyzer.
(9) Adjust level in venous drip chamber.
・ Check that clamp of level adjusting line is closed.
・ Open cap of the line to connect syringe.
・ Remove clamp and adjust level in the chamber to desired height by pushing or
pulling syringe plunger.
・ Close clamp of the line.
(10) When priming with saline of target volume is completed, it is notified by buzzing and
[ON/OFF] SW of blood pump is turned off automatically to stop blood pump. Press
[MUTE] SW and [RESET] SW to mute buzzing and to erase alarm message respectively.

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(11) Check no air in blood line.
(12) Close clamp of venous shunt joint line not to allow discharge of saline.
(13) Turnover dialyzer to direct arterial port (red) upward.
(14) Close rolling clamp of saline vial line and clamp of saline line attached to blood line.
(15) Press [F・4] SW during priming screen is displayed to complete priming operation.

15.6.4.2. When priming function is not used


(1) Turn on [ON/OFF] SW of blood pump to operate it with flow rate indication.
(2) Set flow rate by operating flow rate adjusting volume of blood pump.
(3) Remove air from dialyzer.
(4) Adjust level in venous drip chamber.
・ Check that clamp of level adjusting line is closed.
・ Open cap of the line to connect syringe.
・ Remove clamp and adjust level in the chamber to desired height by pushing or
pulling syringe plunger.
・ Close clamp of the line.
(5) After rinsing with suitable volume of saline, turn off [ON/OFF] SW of blood pump to stop
it without flow rate indication.
(6) Check no air in blood line.
(7) Close clamp of venous shunt joint line not to allow discharge of saline.
(8) Turnover dialyzer to direct arterial port (red) upward.
(9) Close rolling clamp of saline vial line and clamp of saline line attached to blood line.

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15.7. Check of dialysate conductivity
(1) Prepare instrument allowing accurate measurement of conductivity within range from
10.0 to 18.0mS/cm.
(2) Prepare syringe used to take dialysate sample.
(3) Take the sample from sampling port of the machine using syringe.
(4) Measure conductivity of the sample.
(5) Check whether conductivity conforms to requirement.

15.8. Setting of UF related parameters


(1) Check that indicated “UF REMOVED” is 0.00.
(2) Set target UF volume by pressing [△] or [▽] SW for setting of “UF GOAL”.
(3) Set UFR by pressing [△] or [▽] SW for setting of “UF RATE”. By the setting, “TIME
LEFT” value is computed and indicated automatically.

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15.9. Connection of patient

CAUTION
z The following method is example to connect patient to the machine when Nipro dry type
hollow fiber dialyzer and blood line are used. When other dialyzer and blood line are
used by any reason, follow instruction specified by the manufacturer.

(1) Connect arterial shunt joint line to arterial access line of AVF needle retained in patient
by inserting male Luer in female Luer followed by turning red locking Luer to engage
the both securely.
(2) Open clamp of the joint line together with that of the access line.
(3) Open clamp of venous shunt joint line.
(4) Open clamps of arterial and venous pressure monitor lines.
(5) Turn flow rate setting volume of blood pump to the left fully.
(6) Turn on [ON/OFF] SW of blood pump to operate it with flow rate indication.
(7) Set flow rate by operating flow rate setting volume of the pump.
(8) Stop the pump by turning off [ON/OFF] SW of it when blood is introduced in venous
drip chamber.
(9) Clamp venous shunt joint line.
(10) Disconnect recirculation connector from venous shunt joint line to discard.
(11) Connect venous shunt joint line to venous access line of AVF needle retained in patient.
(12) Remove clamp from venous shunt joint line under clamping venous access line of
patient.
(13) Tap venous shunt joint line lightly to shift bubble to inside of venous drip chamber.
(14) Open clamp of venous access line of patient.
(15) Turn flow rate setting volume of blood pump to the left fully.
(16) Turn on [ON/OFF]SW of blood pump to operate it with flow rate indication.
(17) Set flow rate by operating flow rate setting volume of blood pump.
(18) Open clamp of syringe infusion line.
(19) Turn on [ON/OFF] SW of syringe pump to operate it with flow rate indication.
(20) Set flow rate by pressing [△] or [▽] SW of syringe pump.

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15.10. Start of dialysis (dialysis process)

1. Start dialysis.
2. Set upper and lower venous pressure alarm limits.
3. Set upper and lower arterial pressure alarm limits.
4. Set upper and lower dialysate pressure alarm limits.

15.10.1. Start of dialysis


(1) Check that [PREP.] SW lamp is ON.
(2) Check that [BYPASS] SW lamp is OFF.
(3) Check that the machine is operated normally.
(4) Press [UF DIALYSE] SW once.
z[UF DIALYSE] SW lamp is ON.
z[PREP.] SW lamp is OFF.

15.10.2. Setting of upper and lower venous pressure alarm limits


The limits are set automatically. When the limits are set manually, follow the below
procedures:
(1) Set the upper limit by operating [<] or [>] SW for the upper limit setting.
(2) Set the lower limit by operating [<] or [>] SW for the lower limit setting.
(3) Check correct setting.

15.10.3. Setting of upper and lower arterial pressure alarm limits


The setting is enabled only when required option is used. The limits are set automatically.
When the limits are set manually, follow the below procedures:
(1) Press [F・5] SW to display settingⅠscreen.
(2) Press [F・3] or [F・4] SW to blink "2.BAR GRAPH".
(3) Press [F・1] or [F・2] SW to set "AP".
(4) Check correct setting.

[SETTING1]
1.TEMP (°C):37.0 2.BAR GRAPH :DP
3.S.STP(min): 0 4.BOLUS (ml):0.0
+ - < > DISP.

F・1 F・2 F・3 F・4 F・5

zDP :Dialysate pressure indication in DP/AP indicator with DP indicating lamp ON


zAP :Arterial pressure indication in DP/AP indicator with AP indicating lamp ON

(5) Check that AP indicating lamp is ON.


(6) Set the upper limit by operating [<] or [>] SW for the upper DP/AP limit setting.
(7) Set the lower limit by operating [<] or [>] SW for the lower DP/AP limit setting.
(8) Check correct setting.

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15.10.4. Setting of upper and lower dialysate pressure alarm limits
If arterial pressure alarm unit (option) is not used. the following steps from (1) to (4) are not
required.
The limits are set automatically. When the limits are set manually, follow the below
procedures:

(1) Press [F・5] SW to display settingⅠscreen.


(2) Press [F・3] or [F・4] SW to blink "2.BAR GRAPH".
(3) Press [F・1] or [F・2] SW to set "DP".
(4) Check correct setting.

[SETTING1]
1.TEMP (°C):37.0 2.BAR GRAPH :DP
3.S.STP(min): 0 4.BOLUS (ml):0.0
+ - < > DISP.

F・1 F・2 F・3 F・4 F・5

zDP :Dialysate pressure indication in DP/AP indicator with DP indicating lamp ON


zAP :Arterial pressure indication in DP/AP indicator with AP indicating lamp ON

(5) Check that DP indicating lamp is ON.


(6) Set the upper limit by operating [<] or [>] SW for the upper DP/AP limit setting.
(7) Set the lower limit by operating [<] or [>] SW for the lower DP/AP limit setting.
(8) Check correct setting.
(9) Press [F・5] SW to display dialysis screen.

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15.11. Completion of dialysis (recovery process)

1. Check UF completion.
2. Start blood recovery.
3. Execute blood recovery.
4. Remove coupler.
5. Clear away.
6. Complete blood recovery.

15.11.1. Check of UF completion


(1) Check that “PREFORMED TARGET UF " is alerted.
(2) Check conformance of "UF GOAL" value to "UF REMOVED" value.
(3) When "MINIMUM UF" is set, check that “MINIMUM UF” function is executed.
(4) Check that fluid lines are functioning normally.
(5) Press [MUTE] SW and [RESET] SW to mute buzzing to alert “PREFORMED TARGET UF " and
erase the alarm message respectively.

15.11.2. Start of blood recovery


(1) Press [PREP.] SW once.
z[PREP.] SW lamp is ON.
z[UF DIALYSE] SW lamp is OFF.
zFluid lines are functioning normally.
zUF is stopped.

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15.11.3. Execution of blood recovery
(1) Turn on [BYPASS] SW to enable bypass mode with [BYPASS] SW lamp ON.
(2) Turn off [ON/OFF] SW of syringe pump to stop it without flow rate indication.
(3) Turn off [ON/OFF] SW of blood pump to stop it without flow rate indication.
(4) Set saline vial to hanger.
(5) Fill drip chamber of saline infusion set with saline until the level in the chamber arrives
at 1/2 to 3/4 of full height of it.
(6) Clamp arterial shunt joint line and arterial access line of AVF needle at positions near
their connected part.
(7) Clamp syringe infusion line.
(8) Disconnect arterial shunt joint line from arterial access line of AVF needle.
(9) Connect arterial shunt joint line to saline vial through saline line and open clamp of the
line.
(10) Turn flow rate setting volume of blood pump to the left fully.
(11) Turn on [ON/OFF] SW of blood pump to operate it with flow rate indication.
(12) Set flow rate by operating flow rate setting volume of blood pump.
(13) Pass sufficient volume of saline through blood line and dialyzer to recover blood from
them.
(14) When saline arrives at position near distal end of venous line, turn off [ON/OFF] SW of
blood pump to stop it without flow rate indication.
(15) Clamp venous shunt joint line.
(16) Clamp venous access line of AVF needle of patient and disconnect it from venous
shunt joint line.

15.11.4. Removal of coupler


(1) Turnover dialyzer to direct venous port (blue) upward.
(2) Check that bypass operation is enabled and that [BYPASS] SW lamp is ON.
(3) Remove coupler (blue) from dialysate inlet port of dialyzer.
(4) Press [DRAIN] SW once to start draining with indication of <DRAIN> at upper part of
screen. The draining is executed for specified time followed by the draining stop
without indication of <DRAIN> at the part.
(5) Check that dialysate is discharged from dialyzer.
(6) Disconnect coupler (red) from dialysate outlet port of dialyzer and connect the coupler
to intermediate connector followed by setting them to coupler receiver.

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15.11.5.Clearing away
(1) Turn off [ON/OFF] SW of bubble detector.
(2) Close clamp of saline line.
(3) Open blood pump cover.
(4) Remove rolling tube of blood line from blood pump.
(5) Remove venous main tube from bubble detector and clamp.
(6) Clamp arterial pressure monitor line and disconnect the line from arterial pressure inlet
port.
(7) Clamp venous pressure monitor line and disconnect the line from venous pressure inlet
port.
(8) Dislodge syringe from its holder.
(9) Dislodge dialyzer from its holder.
(10) Dislodge arterial drip chamber from its holder.
(11) Dislodge venous drip chamber from its holder.
(12) Discard used dialyzer, blood line, saline vial and syringe.

15.11.6. Completion of blood recovery


(1) Press [DIALYSIS] SW once.
z[DIALYSIS] SW lamp is OFF.
z[PREP.] SW lamp is OFF.
z[BYPASS] SW lamp is OFF.
zFluid line function is disabled.
zShift to rinse wait process is followed.
(2) Remove concentrate line connectors from dialysate concentrate connectors and
connect the line connectors to respective rinse ports.
(3) Check correct connector connection.

CAUTION
z Execute post rinsing based on procedures specified in Chapter 14.

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15.12. Discontinuance of dialysis
By executing blood recovery, UF operation is discontinued and by shift to bypass mode
during recovery process, dialysis is discontinued. .

Discontinue UF.
Discontinue dialysis.

15.12.1. Discontinuance of UF
(1) Press [PREP.] SW once.
z[PREP.] SW lamp is ON.
z[UF DIALYSE] SW lamp is OFF.
zShift to recovery process is followed.
zFluid lines are functioning normally.
zUF is stopped.

CAUTION
z UF can be stopped by setting UFR to 0.00L/h.
z When [PREP.] SW is pressed to shift to recovery process and to disable UF, setting of all
pressure alarm limit is released. Set the limits manually if required.
z When [PREP.] SW is pressed to shift to recovery process and to disable UF , “MINIMUM
UF” function is disabled.

15.12.2. Discontinuance of dialysis


(1) Press [BYPASS] SW once.
z[BYPASS] SW lamp is ON.
zDialysate supply to dialyzer is stopped.

CAUTION
z When bypass mode is selected during dialysis, dialysate supply to dialyzer is stopped,
while UF continues.
z When bypass mode is selected during blood recovery process, dialysate supply to
dialyzer is stopped in addition to UF stop already executed.

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Chapter 16

SINGLE NEEDLE DIALYSIS


1. Set dialysis related parameters.
2. Connect concentrate(s) to the machine.
3. Set blood line, dialyzer and syringe to the machine.
4. Start preparation process of the machine (preparation process)..
5. Check preparation completion of the machine (preparation end process).
6. Execute priming operation.
7. Check dialysate conductivity.
8. Set UF related parameters.
9. Connect patient to the machine.
10. Set single needle dialysis related parameters.
11. Start dialysis (dialysis process).
12. Terminate dialysis (recovery process).
13. Discontinue dialysis (recovery process).

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16.1. Setting of dialysate related parameters

1. Set dialysis mode.


2. Set dialysate concentration.
3. Set dialysate temperature.

16.1.1. Setting of dialysis mode


(1) Press [F・5] SW to display settingⅡscreen.
(2) Press [F・3] or [F・4] SW to blink "4.MODE".
(3) Press [F・1] or [F・2] SW to change setting.
(4) Check correct setting.

[SETTING2]
1.BC(W+A+B) :140 2.BC(W+A) :110
3.AC(W+AC) :140 4.MODE :BC1
+ - < > DISP.

F・1 F・2 F・3 F・4 F・5

zBC1(BICARBONATE1) :Execution of bicarbonate dialysis


zBC2(BICARBONATE2) :Execution of bicarbonate dialysis
zAC(ACETATE) :Execution of acetate dialysis

WARNING
z Information concerning concentrate for each of BC1, BC2 and AC is found in
maintenance mode 5 screen. Set dialysis mode conforming to concentrate(s) intended to
be used.
z Both BC1 and BC2 are bicarbonate dialysis. Information not related to concentrate(s)
intended to be used may be shown in maintenance mode 5 screen. Take care of this.

16.1.2. Setting of dialysate concentration


16.1.2.1. Bicarbonate dialysate
(1) Press [F・5] SW to display settingⅡscreen.
(2) Press [F・3] or [F・4] SW to blink "1.BC(W+A+B)".
(3) Press [F・1] or [F・2] SW to change setting.
(4) Press [F・3] or [F・4] SW to blink "2.BC(W+A)".
(5) Press [F・1] or [F・2] SW to change setting.
(6) Check correct setting.

[SETTING2]
1.BC(W+A+B) :140 2.BC(W+A) :110
3.AC(W+AC) :140 4.MODE :BC1
+ - < > DISP.

F・1 F・2 F・3 F・4 F・5

z1.BC(W+A+B) :Setting of final concentration of bicarbonate dialysate by mmol/l unit


z2.BC(W+A) :Setting of concentration of [water + A concentrate] in bicarbonate
dialysate by mmol/l unit
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16.1.2.2. Acetate dialysate
(1) Press [F・5] SW to display settingⅡscreen.
(2) Press [F・3] or [F・4] SW to blink "3.AC(W+AC)".
(3) Press [F・1] or [F・2] SW to change setting.
(4) Check correct setting.

[SETTING2]
1.BC(W+A+B) :140 2.BC(W+A) :110
3.AC(W+AC) :140 4.MODE :BC1
+ - < > DISP.

F・1 F・2 F・3 F・4 F・5

z3.AC(W+AC) :Setting of final concentration of acetate dialysate by mmol/l unit

16.1.3. Setting of dialysate temperature


(1) Press [F・5] SW to display settingⅠscreen.
(2) Press [F・3] or [F・4] SW to blink "1.TEMP(℃)".
(3) Press [F・1] or [F・2] SW to change setting.
(4) Check correct setting.

[SETTING1]
1.TEMP (°C):37.0 2.BAR GRAPH :DP
3.S.STP(min): 0 4.BOLUS (ml):0.0
+ - < > DISP.

F・1 F・2 F・3 F・4 F・5

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16.2. Connection of concentrates

CAUTION
z Connect each concentrate connector and rinse port securely to prevent troubles such as
water leak and air aspiration.
z Use A and B concentrates for preparing bicarbonate dialysate and acetic acid concentrate
for preparing acetate dialysate of specified concentrations.

16.2.1. Connection of concentrates to prepare bicarbonate dialysate


(1) A concentrate line connector is connected to rinse port. Disconnect the line connector
from the port by pulling the line connector under moving ring of the port to this side.
(2) Full push the disconnected connector against A concentrate container connector until
click is heard.
(3) Bconcentrate line connector is connected to rinse port. Disconnect the line connector
from the port by pulling the line connector under moving ring of the port to this side.
(4) Full push the disconnected connector against B concentrate container connector until
click is heard.
(5) Connect other concentrate line connectors to respective rinse ports or engage them
with respective connector receivers.
(6) Check correct connector connection.

16.2.2. Connection of concentrate to prepare acetate dialysate


(1) A concentrate line connector is connected to rinse port. Disconnect the connector from
the port by pulling the connector under moving ring of the port to this side.
(2) Full push the disconnected connector against A concentrate container connector until
click is heard.
(3) Connect other concentrate line connectors to respective rinse ports or engage them
with respective connector receivers.
(4) Check correct connector connection.

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16.3. Setting of blood line, dialyzer and syringe

1. Set blood line to the machine.


2. Set dialyzer to the machine.
3. Set syringe to syringe pump.
4. Setting of syringe pump

16.3.1. Setting of blood line


(1) Prepare blood line authorized by us or the equivalent.
(2) Check no damage of the line.
(3) Close clamp on level adjusting line in arterial side and that on arterial pressure monitor
line followed by setting arterial drip chamber to holder.
(4) When arterial pressure sensor (option) is used, connect the pressure monitor line to
pressure inlet of arterial pressure sensor under care of no line folding and/or twisting.
(5) Open blood pump cover.
(6) Load rolling tube in arterial line to blood pump. Insert the tube in space between the
pump rotor and housing and rotate the pump clockwise manually.
(7) Close the pump cover.
(8) Close clamp on level adjusting line in venous side and that on venous pressure monitor
line followed by setting venous drip chamber to holder.
(9) Connect the monitor line to pressure inlet of venous pressure sensor under care of no
line folding and/or twisting.
(10) Load bubble detector to main venous tube by holding top and bottom of the detector by
fingers.
(11) Load clamp to main venous tube.

16.3.2. Setting of dialyzer


(1) Set dialyzer to holder under directing venous side (blue) upward.
(2) Connect arterial line to arterial port (red) of dialyzer.
(3) Connect venous line to venous port (blue) of dialyzer.

16.3.3. Setting of syringe


(1) Remove air from fluid drug contained in syringe by advancing plunger.
(2) Shift pusher of syringe pump to the right end under pressing it.
(3) Set syringe to holder of the pump so that syringe plunger is received in slit of the
pusher.
(4) Fix syringe by turning syringe holding lever.

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16.3.4. Setting of syringe pump
16.3.4.1. Setting of cross-section ratio of syringe
Calculate ratio of cross-sectional area of syringe intended to be used to that of Nipro 20ml
syringe (292.5mm2) as 100% and set the ratio.
When the set ratio is 50%, pusher moves at a doubled speed compared with the case that
the ratio is 100% with exception that the speed is defined in the case of bolus infusion.
When the set ratio is 200%, it moves at a half speed compared with the case that the ratio is
100% with the exception.

(1) Press [F・5] SW to display maintenance mode 7 screen.


(2) Press [F・3] or [F・4] SW to indicate "20.MAINTENANCE MODE FREE".

[MAINTE 7]
20.MAINTENANCE MODE FREE : OFF

UP DOWN MENU

F・1 F・2 F・3 F・4 F・5

(3) Press [F・1] SW to set to "ON".

[MAINTE 7]
20.MAINTENANCE MODE FREE : ON

+ - UP DOWN MENU

F・1 F・2 F・3 F・4 F・5

(4) Instruction appears in [F・1] or [F・2] SW (+/-). Check that setting is enabled by
blinking of items to be set.
(5) Press [F・3] or [F・4] SW to blink "1.SYRINGE RATE".
(6) Press [F・1] or [F・2] SW to change set value.

[MAINTE 7]
1.SYRINGE RATE : 100
2.BP STOP AFTER POWER FAIL : OFF
+ - UP DOWN MENU

F・1 F・2 F・3 F・4 F・5

(7) Press [F・3] or [F・4] SW to indicate "20.MAINTENANCE MODE FREE".


(8) Press [F・1] SW to set to "OFF".

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16.3.4.2. Setting of syringe operation stop time
By the setting, automatic syringe operation stop is enabled at a set time before UF
completion and the stop is indicated by error message "E61 COMPLETION OF SYRINGE.P
INFUSION".

(1) Press [F・5] SW to display settingⅠscreen.


(2) Press [F・3] or [F・4] SW to blink "3.S.STP(min)".
(3) Press [F・1] or [F・2] SW to change set value.
(4) Check the changed set value.

[SETTING1]
1.TEMP (°C):37.0 2.BAR GRAPH :DP
3.S.STP(min): 0 4.BOLUS (ml):0.0
+ - < > DISP.

F・1 F・2 F・3 F・4 F・5

16.3.4.3. Setting of fast-forward volume


By pressing [F.F.] SW during syringe pump operation, pusher moves at fast forward speed.
Pusher moves a specified speed to perform bolus infusion followed by automatic returning
to the
normal infusion after infusing a set infusate volume.

(1) Press [F・5] SW to display settingⅠscreen.


(2) Press [F・3] or [F・4] SW to blink "4.BOLUS(ml)".
(3) Press [F・1] or [F・2] SW to change set value.
(4) Check the changed set value.

[SETTING1]
1.TEMP (°C):37.0 2.BAR GRAPH :DP
3.S.STP(min): 0 4.BOLUS (ml):0.0
+ - < > DISP.

F・1 F・2 F・3 F・4 F・5

z0.0 :Bolus infusion during pressing [F.F] SW only until reaching to maximum
infusion
as 5 mL. Return regular infusion automatically when bolus infusion is
reached to
maximum infusion.
z0.5-5.0 :Bolus infusion of set infusate volume

CAUTION
z Syringe pump may not stop infusing after releasing [F.F] SW by some malfunction.
In this case, stop syringe pump by turn OFF the breaker of the machine and then
interrupt
treatment. Machine must be disconnected from patient.

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16.4. Preparation of machine (preparation process)
(1) Press [F・5] SW to display dialysis screen.
(2) Press [PREP.] SW once.
z[PREP.] SW lamp is flashing.
z[BYPASS] SW lamp is flashing.
zDialysate preparation is started.

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


(1) Check that [PREP.] SW lamp is ON.
(2) Check that [BYPASS] SW lamp is OFF.
(3) Check normal operation of the machine.

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16.6. Priming process

CAUTION
z Follow instruction of dialyzer manufacturer to know “which should be preceded blood or
dialysate compartment when dialyzer is primed”.
z In the case of priming blood compartment, when “priming function” is used, follow
instruction specified in 15.6.4.1. If the function is not used, follow instruction specified in
15.6.4.2.
z Priming method may be specified by each hospital or medical facilities. Prime dialyzer
based on method specified by it unless function and performance of the machine is
damaged. The method described in this manual is example.

1. Set saline vial to hanger.


2. Prime blood line with saline.
3. Prime dialysate compartment of dialyzer with dialysate.
4. Rinse blood line and blood compartment of dialyzer.

16.6.1. Setting of saline vial


(1) Set saline vial to hanger.
(2) Fill drip chamber of saline infusion set with saline until level in the chamber arrives at
1/2 to 3/4 of full height of it.
(3) Clamp saline line of arterial side.
(4) Connect the line to the infusion set.

16.6.2. Priming of saline


(1) After checking that level adjusting line of arterial side is clamped and that arterial shunt
joint line is not clamped, open clamp of saline line.
Rinse the shunt joint line with required volume of saline by gravity flow.
(2) Close clamp of the joint line to stop saline flow.
(3) Rinse syringe infusion line.
・ Remove Luer cap from the line and put in waste container.
・ Open clamp of the line.
・ Open blood pump cover.
・ Rinse the line with required volume of saline by turning blood pump rotor clockwise
manually under closing dialyzer side of blood line.
・ Close blood pump cover.
・ Close clamp of the infusion line.
・ Connect the line to syringe set to syringe pump.
・ Open clamp of the line.
(4) After checking that level adjusting line of venous side is clamped and venous shunt
joint line is not clamped, turn on [ON/OFF] SW of blood pump to operate it with flow rate
indication.

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(5) Set flow rate by operating flow rate setting volume of blood pump.
(6) Adjust level in arterial drip chamber.
・ Check that clamp of level adjusting line is closed.
・ Open cap of the line to connect syringe.
・ Remove clamp and adjust level in arterial drip chamber to desired height by pushing
or pulling syringe plunger.
・ Close clamp of the line.
(7) After venous tube is primed with saline up to its distal end, turn off [ON/OFF] SW of
blood pump to stop it without flow rate indication.

16.6.3. Priming of dialyzer with dialysate


(1) Turnover dialyzer to direct arterial port (red) upward.
(2) Turn on [BYPASS] SW to enable bypass mode. [BYPASS] SW lamp is ON.
(3) Set coupler to dialyzer and place intermediate connector of the coupler on coupler
receiver.
(4) Turn off [BYPASS] SW to release bypass mode. [BYPASS] SW lamp is OFF.
(5) Check air removal from dialyzer.
(6) Turnover dialyzer to direct venous port (blue) upward.

16.6.4. Rinsing of blood line and dialyzer


16.6.4.1. When priming function is used
(1) Press [F・5] SW to display dialysis screen.
(2) Press [F・3] SW to display priming screen.

[PRIMING]
SOLUTION VOL.(l):5.00
ACCUMULATED VOL.(l):5.00 RATIO(%):100
+ - EXIT DISP.

F・1 F・2 F・3 F・4 F・5

(3) Press [F・1] or [F・2] SW to set "SOLUTION VOL.(l)" to suitable level so that small
amount of saline can be left in vial after priming completion.
(4) Check that "ACCUMULATED VOL.(l)" is 0.00.
(5) Check that "RATIO(%)" is 0.
(6) Set flow rate by operating flow rate adjusting volume of blood pump.
(7) Turn on [ON/OFF] SW of blood pump to operate it.
(8) Remove air from dialyzer.
(9) Adjust level in venous drip chamber.
・ Check that clamp of level adjusting line is closed.
・ Open cap of the line to connect syringe.
・ Remove clamp and adjust level in the chamber to desired height by pushing or
pulling syringe plunger.
・ Close clamp of the line.
(10) When priming with saline of target volume is completed, it is notified by buzzing and
[ON/OFF] SW of blood pump is turned off automatically to stop blood pump. Press
[MUTE] SW and [RESET] SW to mute buzzing and to erase alarm message respectively.

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(11) Check no air in blood line.
(12) Close clamp of venous shunt joint line not to allow discharge of saline.
(13) Turnover dialyzer to direct arterial port (red) upward.
(14) Close rolling clamp of saline vial line and clamp of saline line attached to blood line.
(15) Press [F・4] SW during priming screen is displayed to complete priming operation.

16.6.4.2. When priming function is not used


(1) Turn on [ON/OFF] SW of blood pump to operate it with flow rate indication.
(2) Set flow rate by operating flow rate adjusting volume of blood pump.
(3) Remove air from dialyzer.
(4) Adjust level in venous drip chamber.
・ Check that clamp of level adjusting line is closed.
・ Open cap of the line to connect syringe.
・ Remove clamp and adjust level in the chamber to desired height by pushing or
pulling syringe plunger.
・ Close clamp of the line.
(5) After rinsing with suitable volume of saline, turn off [ON/OFF] SW of blood pump to stop
it without flow rate indication.
(6) Check no air in blood line.
(7) Close clamp of venous shunt joint line not to allow discharge of saline.
(8) Turnover dialyzer to direct arterial port (red) upward.
(9) Close rolling clamp of saline vial line and clamp of saline line attached to blood line.

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16.7. Check of dialysate conductivity
(1) Prepare instrument allowing accurate measurement of conductivity within range from
10.0 to 18.0mS/cm.
(2) Prepare syringe used to take dialysate sample.
(3) Take the sample from sampling port of the machine using syringe.
(4) Measure conductivity of the sample.
(5) Check whether conductivity conforms to requirement.

16.8. Setting of UF related parameters


(1) Check that indicated “UF REMOVED” is 0.00.
(2) Set target UF volume by pressing [△] or [▽] SW for setting of “UF GOAL”.
(3) Set UFR by pressing [△] or [▽] SW for setting of “UF RATE”. By the setting, “TIME
LEFT” value is computed and indicated automatically.

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16.9. Connection of patient

CAUTION
z The following method is example to connect patient to the machine when Nipro dry type
hollow fiber dialyzer and blood line are used. When other dialyzer and blood line are used
by any reason, follow instruction specified by the manufacturer.

(1) Connect arterial shunt joint line to arterial access line of AVF needle retained in patient
by inserting male Luer in female Luer followed by turning red locking Luer to engage
the both securely.
(2) Open clamp of the joint line together with that of the access line.
(3) Open clamp of venous shunt joint line.
(4) Open clamps of arterial and venous pressure monitor lines.
(5) Turn flow rate setting volume of blood pump to the left fully.
(6) Turn on [ON/OFF] SW of blood pump to operate it with flow rate indication.
(7) Set flow rate by operating flow rate setting volume of the pump.
(8) Stop the pump by turning off [ON/OFF] SW of it when blood is introduced in venous
drip chamber.
(9) Clamp venous shunt joint line.
(10) Disconnect recirculation connector from venous shunt joint line to discard.
(11) Connect venous shunt joint line to venous access line of AVF needle retained in patient.
(12) Remove clamp from venous shunt joint line under clamping venous access line of
patient.
(13) Tap venous shunt joint line lightly to shift bubble to inside of venous drip chamber.
(14) Open clamp of venous access line of patient.
(15) Turn flow rate setting volume of blood pump to the left fully.
(16) Turn on [ON/OFF]SW of blood pump to operate it with flow rate indication.
(17) Set flow rate by operating flow rate setting volume of blood pump.
(18) Open clamp of syringe infusion line.
(19) Turn on [ON/OFF] SW of syringe pump to operate it with flow rate indication.
(20) Set flow rate by pressing [△] or [▽] SW of syringe pump.

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16.10. Setting of single needle dialysis related parameters

1. Turn on single needle SW.


2. Set single needle changeover values.

16.10.1. Single needle SW ON


(1) Press [F・5] SW to display dialysis screen.
(2) Press [F・1] SW to enable single needle dialysis.
(3) Check indication of <SINGLE.N>.

[DIALYSIS] <SINGLE.N>
VP: 140mmHg DP: 100mmHg COND:14.0mS/cm
AP:-100mmHg TMP: 40mmHg TEMP:37.0゜C
S.N. SQHD PRIM TEST DISP.

F・1 F・2 F・3 F・4 F・5

NOTE
z By turning on single needle SW, changeover and alarm points are indicated in venous
pressure indicator. Inside point shows single needle changeover point and outside point
shows single needle alarm point.
z Press [UF DIALYSE] SW to start single needle dialysis.

16.10.2. Setting of single needle changeover values


Set upper and lower single needle changeover values manually.
(1) Set the upper limit by operating [<] or [>] for upper venous pressure alarm limit
setting.
(2) Set the lower limit by operating [<] or [>] for lower venous pressure alarm limit setting.
(3) Check correct setting.

NOTE
z By setting single needle changeover value, single needle alarm value is also set
automatically.
z If the changeover value is not set manually, the value is set automatically by pressing
[UF DIALYSE] SW.

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16.11. Start of dialysis (dialysis process)

1. Start dialysis.
2. Set upper and lower arterial pressure alarm limits (option).
3. Set upper and lower dialysate pressure alarm limits.

16.11.1. Start of dialysis


(1) Check that [PREP.] SW lamp is ON.
(2) Check that [BYPASS] SW lamp is OFF.
(3) Check that the machine is operated normally.
(4) Press [UF DIALYSE] SW once.
z[UF DIALYSE] SW lamp is ON.
z[PREP.] SW lamp is OFF.
(5) Single needle dialysis is started.

16.11.2. Setting of upper and lower arterial pressure alarm limits


The setting is enabled only when required option is used. The limits are set automatically
sometime after pressing [UF DIALYZE] SW. When the limits are set manually, follow the below
procedures:
(1) Press [F・5] SW to display settingⅠscreen.
(2) Press [F・3] or [F・4] SW to blink "2.BAR GRAPH".
(3) Press [F・1] or [F・2] SW to set "AP".
(4) Check correct setting.

[SETTING1]
1.TEMP (°C):37.0 2.BAR GRAPH :DP
3.S.STP(min): 0 4.BOLUS (ml):0.0
+ - < > DISP.

F・1 F・2 F・3 F・4 F・5

zDP :Dialysate pressure indication in DP/AP indicator with DP indicating lamp ON


zAP :Arterial pressure indication in DP/AP indicator with AP indicating lamp ON

(5) Check that AP indicating lamp is ON.


(6) Set the upper limit by operating [<] or [>] SW for the upper DP/AP limit setting.
(7) Set the lower limit by operating [<] or [>] SW for the lower DP/AP limit setting.
(8) Check correct setting.

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16.11.3. Setting of upper and lower dialysate pressure alarm limits
If arterial pressure alarm unit (option) is not used, the following steps from (1) to (4) are not
required.
The limits are set automatically sometime after pressing [UF DIALYZE] SW. When the limits
are set manually, follow the below procedures:
(1) Press [F・5] SW to display settingⅠscreen.
(2) Press [F・3] or [F・4] SW to blink "2.BAR GRAPH".
(3) Press [F・1] or [F・2] SW to set "DP".
(4) Check correct setting.

[SETTING1]
1.TEMP (°C):37.0 2.BAR GRAPH :DP
3.S.STP(min): 0 4.BOLUS (ml):0.0
+ - < > DISP.

F・1 F・2 F・3 F・4 F・5

zDP :Dialysate pressure indication in DP/AP indicator with DP indicating lamp ON


zAP :Arterial pressure indication in DP/AP indicator with AP indicating lamp ON

(5) Check that DP indicating lamp is ON.


(6) Set the upper limit by operating [<] or [>] SW for the upper DP/AP limit setting.
(7) Set the lower limit by operating [<] or [>] SW for the lower DP/AP limit setting.
(8) Check correct setting.
(9) Press [F・5] SW to display dialysis screen.

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16.12. Completion of dialysis (recovery process)

1. Check UF completion.
2. Start blood recovery.
3. Execute blood recovery.
4. Remove coupler.
5. Clear away.
6. Complete blood recovery.

16.12.1. Check of UF completion


(1) Check that “PREFORMED TARGET UF " is alerted.
(2) Check conformance of "UF GOAL" value to "UF REMOVED" value.
(3) When "MINIMUM UF" is set, check that “MINIMUM UF” function is executed.
(4) Check that fluid lines are functioning normally.
(5) Press [MUTE] SW and [RESET] SW to mute buzzing to alert “PREFORMED TARGET UF " and
erase the alarm message respectively.

16.12.2. Start of blood recovery


(1) Press [PREP.] SW once.
z[PREP.] SW lamp is ON.
z[UF DIALYSE] SW lamp is OFF.
zFluid lines are functioning normally.
zUF is stopped.

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16.12.3. Execution of blood recovery
(1) Turn on [BYPASS] SW to enable bypass mode with [BYPASS] SW lamp ON.
(2) Turn off [ON/OFF] SW of syringe pump to stop it without flow rate indication.
(3) Turn off [ON/OFF] SW of blood pump to stop it without flow rate indication.
(4) Set saline vial to hanger.
(5) Fill drip chamber of saline infusion set with saline until the level in the chamber arrives
at 1/2 to 3/4 of full height of it.
(6) Clamp arterial shunt joint line and arterial access line of AVF needle at positions near
their connected part.
(7) Clamp syringe infusion line.
(8) Disconnect arterial shunt joint line from arterial access line of AVF needle.
(9) Connect arterial shunt joint line to saline vial through saline line and open clamp of the
line.
(10) Turn flow rate setting volume of blood pump to the left fully.
(11) Turn on [ON/OFF] SW of blood pump to operate it with flow rate indication.
(12) Set flow rate by operating flow rate setting volume of blood pump.
(13) Pass sufficient volume of saline through blood line and dialyzer to recover blood from
them.
(14) When saline arrives at position near distal end of venous line, turn off [ON/OFF] SW of
blood pump to stop it without flow rate indication.
(15) Clamp venous shunt joint line.
(16) Clamp venous access line of AVF needle of patient and disconnect it from venous
shunt joint line.

16.12.4. Removal of coupler


(1) Turnover dialyzer to direct venous port (blue) upward.
(2) Check that bypass operation is enabled and that [BYPASS] SW lamp is ON.
(3) Remove coupler (blue) from dialysate inlet port of dialyzer.
(4) Press [DRAIN] SW once to start draining with indication of <DRAIN> at upper part of
screen. The draining is executed for specified time followed by the draining stop
without indication of <DRAIN> at the part.
(5) Check that dialysate is discharged from dialyzer.
(6) Disconnect coupler (red) from dialysate outlet port of dialyzer and connect the coupler
to intermediate connector followed by setting them to coupler receiver.

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16.12.5. Clearing away
(1) Turn off [ON/OFF] SW of bubble detector.
(2) Close clamp of saline line.
(3) Open blood pump cover.
(4) Remove rolling tube of blood line from blood pump.
(5) Remove venous main tube from bubble detector and clamp.
(6) Clamp arterial pressure monitor line and disconnect the line from arterial pressure inlet
port.
(7) Clamp venous pressure monitor line and disconnect the line from venous pressure inlet
port.
(8) Dislodge syringe from its holder.
(9) Dislodge dialyzer from its holder.
(10) Dislodge arterial drip chamber from its holder.
(11) Dislodge venous drip chamber from its holder.
(12) Discard used dialyzer, blood line, saline vial and syringe.

16.12.6. Completion of blood recovery


(1) Press [DIALYSIS] SW once.
z[DIALYSIS] SW lamp is OFF.
z[PREP.] SW lamp is OFF.
z[BYPASS] SW lamp is OFF.
zFluid line function is disabled.
zShift to rinse wait process is followed.
(2) Remove concentrate line connectors from dialysate concentrate connectors and
connect the line connectors to respective rinse ports.
(3) Check correct connector connection.

CAUTION
z Execute post rinsing based on procedures specified in Chapter 14.

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16.13. Discontinuance of dialysis
By executing blood recovery, UF operation is discontinued and by shift to bypass mode
during recovery process, dialysis is discontinued. .

Discontinue UF.
Discontinue dialysis.

16.13.1. Discontinuance of UF
(1) Press [PREP.] SW once.
z[PREP.] SW lamp is ON.
z[UF DIALYSE] SW lamp is OFF.
zShift to recovery process is followed.
zFluid lines are functioning normally.
zUF is stopped.

CAUTION
z UF can be stopped by setting UFR to 0.00L/h.
z When [PREP.] SW is pressed to shift to recovery process and to disable UF, setting of all
pressure alarm limit is released. Set the limits manually if required.
z When [PREP.] SW is pressed to shift to recovery process and to disable UF , “MINIMUM
UF” function is disabled.

16.13.2. Discontinuance of dialysis


(1) Press [BYPASS] SW once.
z[BYPASS] SW lamp is ON.
zDialysate supply to dialyzer is stopped.

CAUTION
z When bypass mode is selected during dialysis, dialysate supply to dialyzer is stopped,
while UF continues.
z When bypass mode is selected during blood recovery process, dialysate supply to
dialyzer is stopped in addition to UF stop already executed.

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Chapter 17

SEQUENTIAL DIALYSIS
It is possible to execute UF only during double needle or single needle mode in dialysis
process by stopping dialysate flow to dialyzer.
By pressing [F・2] SW during dialysis screen is displayed, sequential dialysis (SQHD) is
started.
WARNING
z Basic procedures can be found in Chapters 15 and 16. Read them.
z If dialyzer is not primed with dialysate, sequential dialysis (SQHD) is disabled.

1. ON setting of sequential dialysis


(1) Press [F・5] SW to display dialysis screen.
(2) Press [F・2] SW to start sequential dialysis.
(3) Check indication of <SQHD> in the screen.

[DIALYSIS] < SQHD >
VP: 140mmHg DP: 100mmHg COND:14.0mS/cm
AP:-100mmHg TMP: 40mmHg TEMP:37.0゜C
S.N. SQHD PRIM TEST DISP.

F・1 F・2 F・3 F・4 F・5

NOTE
z By ON setting during dialysis, sequential dialysis is started immediately.
z When ON is set during any process other than dialysis previously, sequential dialysis is
started immediately after pressing [UF DAIALYSE] SW.
z Immediately after start of sequential dialysis, dialysate flow may not be stopped for
scores of seconds to several minutes to control timing of dialysate flow stop by the
machine. This is not failure of the machine.

2. OFF setting of sequential dialysis


(1) Press [F・5] SW to display dialysis screen.
(2) Press [F・2] SW to stop sequential dialysis.
(3) Check no indication of <SQHD> in the screen.

[DIALYSIS]
VP: 140mmHg DP: 100mmHg COND:14.0mS/cm
AP:-100mmHg TMP: 40mmHg TEMP:37.0゜C
S.N. SQHD PRIM TEST DISP.

F・1 F・2 F・3 F・4 F・5

NOTE
z By OFF setting of sequential dialysis or ON setting of [PREP.]SW, sequential dialysis is
stopped.
z Immediately after stop of sequential dialysis, dialysate flow may be stopped for scores of
seconds to several minutes to control timing of dialysate flow start by the machine. This

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is not failure of the machine.

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Chapter 18

CHECK AND MAINTENANCE


1. Check and maintenance by operator
2. Check and maintenance by engineer
3. Check and maintenance by qualified engineer

WARNING
z During check and maintenance of the machine, DO NOT connect patient to it.

18.1. Check and maintenance by operator


Items to be checked and maintained of the machine by well trained operator or service man
having sufficient knowledge how to check and maintain the machine are as follows:

1. Check and maintenance before and after operation of the machine (at each dialysis)
2. Cleaning of enclosure of the machine (at each dialysis)
3. Disinfection and rinsing of fluid lines (at each dialysis)
4. Acetic acid rinsing of fluid lines (weekly)

18.1.1. Check and maintenance before and after operation


Check the below items before and after operation of the machine to confirm that those are
normal.
(1) No troubles such as leak from circumference of the machine, in particular from fluid
supply ports and loosened hose clamp of drain port
(2) No foreign matters such as chemical on enclosure of the machine
(3) No error when test mode is executed
(4) Closed main valve of water supply side when the machine is not operated overnight
(5) Check syringe can be injected according setting value.

18.1.1.1. Test mode


Functions of the machine are self diagnosed simply by executing test mode.

(1) Before start of test, it is required:


・ To close blood pump cover;
・ Not to connect any object to bubble detector;
・ Not to connect any object to venous pressure sensor and expose the sensor to
atmosphere;
・ Not to connect any object to arterial pressure sensor and expose the sensor to
atmosphere; and
・ Not to connect patient to the machine.

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(2) Test mode is activated only in dialysis wait process. Set the process.
(3) Press [F・5] SW to display dialysis screen.
(4) Press [F・4] SW to execute test. The result is indicated by OK or NG.

[TEST]
BP:OK CLV:OK BD: VPa: VPb:
VP: AP:
EXIT DISP.

F・1 F・2 F・3 F・4 F・5

NOTE
z Self diagnosis is simple one and all checks are not necessarily be performed.
z Self diagnosis can be performed under specified conditions. If any of the conditions is
not satisfied, the result may be NG.
z Although the result is NG, audible alarm is not actuated. Check indication of NG in test
screen
z The following items are self diagnosed:
• BP(blood pump) : Rotation test
• CLV(clamp) : Clamp ON/OFF operation test
• BD(bubble detector) : Bubble detection test
• VPa(viscous pump A) : Rotation test
• VPb(viscous pump B) : Rotation test
• VP(venous pressure sensor): Test to check venous pressure = 0±8mmHg
• AP(arterial pressure sensor): Test to check arterial pressure = 0±8mmHg

18.1.2. Cleaning and disinfection of machine outside


Clean the machine outside based on procedures specified in ”11.1 Cleaning and disinfection
of machine outside.

18.1.3. Disinfection and rinsing of fluid line inside


Disinfect and clean fluid line inside based on procedures specified in “11.3 Disinfection of
fluid line inside 11.3” and “Chapter 14 Rinsing”.

WARNING
z Confirm disinfectant concentrate can be sucked surely and disinfection can be performed
regularly. Take the confirmation once a week. It is possible that third-party infection is
happened due to malfunction of electric valves.

18.1.4. Acetic acid rinsing of fluid lines


Remove calcium deposit from fluid line inside by acid rinsing based on procedures specified
in “11.4 Removal of calcium deposit from fluid line inside” and “Chapter 14 Rinsing”.

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18.2. Regular check by engineer
Check the machine at each time when 500 hours are indicated in hour meter or yearly
whichever earlier.
Check the hour meter indication by selecting SERVICE FREQUENCY in maintenance mode 8.
If error is detected, instruct not to operate the machine and report to qualified engineer
having knowledge how to maintain the machine.

CAUTION
z Disinfect fluid line inside before operating the machine to avoid infection.

1. Check before POWER ON


2. Check of leakage current
3. Check of accuracy of pressure sensor
4. Check of accuracy of syringe pump infusion rate
5. Check of accuracy of UF
6. Check of accuracy of blood leak sensor
7. Check of accuracy of blood pump flow rate
8. Check of accuracy of bubble sensor
9. Check of accuracy of temperature sensor
10. Check of accuracy of conductivity cell
11. Replacement of components of fluid supply filter
12. Replacement of components of electromagnetic valve
13. Replacement of component of pump

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18.2.1. Check before power ON
(1) Required device
Tester
(2) Check no corrosion, loosening and play at each part of connectors being used.
(3) Clean filter of rear panel (Fig. 18-1).
(4) Check that resistance of protective earth is ≦0.1Ω.
Measure the resistance between earth terminal and earth.(Fig. 18-2).
(5) Check no fluid leakage from each part.

Fig. 18-1 Air filter

Earth
earth
t i l

Fig. 18-2 Earth

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18.2.2. Check of leakage current
(1) Required device
Leakage current tester
(2) Set the tester between protective earth terminal of the machine power plug and earth.
(3) Operate the machine under dialysis mode.
(4) When tested, leakage current should be ≦0.5mA.

R1

R2 C1 V

R1=10kΩ
R2=1kΩ
C1=0.015uF

Fig. 18-3 Circuit diagram of leakage current tester

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18.2.3. Check of accuracy of pressure sensor

(1) Required devices


Calibrated manometer, syringe used to pressurize, three way stop cock and air tube
(2) Venous pressure sensor
Connect required devices as shown in Fig. 18-4. When pressures of 0mmHg and
+300mmHg are applied to manometer and the sensor by operating syringe, difference
of
displayed pressure from manometer reading should be within ± 2mmHg and ±
8mmHg
respectively.

(3) Arterial pressure sensor


Connect required devices as shown in Fig. 18-4. When pressures of 0mmHg and
+300mmHg are applied to manometer and the sensor by operating syringe, difference
of
displayed pressure from manometer reading should be within ± 2mmHg and ±
8mmHg
respectively.

(4) Dialysate pressure sensor


Connect required devices as shown in Fig. 18-5. When pressures of 0mmHg and
+300mmHg are applied to manometer and the sensor by operating syringe, difference
of
displayed pressure from manometer reading should be within ± 2mmHg and ±
8mmHg
respectively.
NOTE
z Pressure measured by each sensor appears in maintenance mode 1 screen. Offset value
set in maintenance mode 6 screen is added to the pressure. Subtract the offset value
from the sensor value to compare with the manometer value.

Fig. 18-4 Setup to check accuracy Fig. 18-5 Setup to check accuracy

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of VP or AP sensor of DP sensor

18.2.4. Check of syringe pump

18.2.4.1. Check for fixation of pulley


(1) Required device
Hexagon wrench (2.0mm)
(2) Check fixing screw for pulley is tightening correctly.

18.2.4.2. Check of accuracy of syringe pump infusion rate


(1) Required device
Syringe
(2) Connect syringe to syringe pump as shown in Fig. 18-6 and set syringe infusion rate to
9.9mL/h
followed by operating the pump for one hour.
(3) Check that infused volume collected in the syringe is within 9.0 to 11.0mL.

NOTE
z Actual syringe infusion rate is defined by syringe ratio set in maintenance mode 7 screen.
Define the ratio according to syringe size used. To check accuracy of syringe pump
infusion rate, use the syringe of the defined ratio.

Fig. 18-6 Setup to check accuracy of syringe infusion rate

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18.2.5. Check of accuracy of UF
(1) Required devices
Electronic balance (min calibration:≦0.5 g), container (about 3L), water, tube with
female lure
lock connector and syringe
(2) Dip coupler lines in water received in container as shown in Fig. 18-7.
(3) Advance plunger of syringe connected to venous pressure inlet port through tube to
pressurize to about +50mmHg and keep the pressure.
(4) Operate the machine under dialysis mode at UF RATE=1.00L/h,UF GOAL=1.00L/h.
(5) After UF completion, check that difference of actual UF weight measured by the balance
from
the set UF GOAL volume is within ±30g.

Fig. 18-7 Setup to check accuracy of UF

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18.2.6. Check of accuracy of blood leak sensor

18.2.6.1. Visual check of blood leak sensor

(1) Remove cartridge from blood leak detector.


(2) Confirm the dirt from surface of glass parts.
Wipe glass parts with soft cloth if it seems dirty.
(3) Confirm the dirt from inside of cartridge.
Perform water or disinfection if it seems dirty.
(4) Return cartridge to blood leak detector. Confirm the direction of O-ring when
returning cartridge.

Cartridge can be
removed by loosing

Note)It is not necessary to remove


silicone tube.

Fig.18-8 Remove cartridge

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18.2.6.2. Zero revision of blood leak sensor

Adjust the zero revision of blood leak detector when “6.BLD AUTO ZERO” value less
than
-150ppm in maintenance mode 1 screen during preparation process.

CAUTION
z Perform water rinse or disinfection before you calibrate it.
It caused of display error if you calibrate it even blood leak detector is dirty.

(1) Press [Prep.] SW to shift to preparation process.


(2) Check preparation time pass over 5 minutes.
(3) Turn adjustment volume 1 counterclockwise.
Adjust “6.BLD AUTO ZERO” value to -40~-30ppm.

Adjustment value Adjustment point


Maintenace mode 1 : BLD AUTO Adjustment volume
-40~-30ppm
ZERO 1

(※1) Check no bubble inside cartridge of blood leak detector.


(※2) DO NOT turn adjustment volume 1 counterclockwise too much.
BLD value is displayed lower than actual value.

[MAINTE 1]
6.BLD AUTO ZERO : ―30
7.BLD SENS VALUE : ――――――
UP DOWN MENU
F・1 F・2 F・3 F・4 F・5

Fig.18-9 Maintence mode 1 screen

BLD cover Blood leak detector

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Adjustment volume

18.2.7. Check of accuracy of blood pump flow rate


18.2.7.1. When electronic balance is used
(1) Required devices
Blood line, dialyzer, stopwatch and 2 containers (each of about 1L)
(2) Set blood line and dialyzer to the machine to prime them with water.
(3) Set blood pump flow rate to 100mL/min and turn off [ON/OFF] SW of the pump.
(4) Put water in one container and place other empty container on electronic balance.
(5) Put arterial line in the water container.
(6) Put venous line in the empty container.
(7) Press [ON/OFF] SW of blood pump to operate it at 100mL/min.
(8) At time of resetting the balance, start stopwatch operation.
(9) 3 minutes after the start, check that indication of the balance is 300g±10%.

Blood line
血液回路

BP

WATER

電子ハカリ

Electronic balance

Fig. 18-12 Setup to check accuracy of blood pump flow rate

18.2.7.2. When measuring cylinder is used


(1) Required devices
Blood line, dialyzer, stopwatch, container (about 1L) and measuring cylinder (about 1L)
(2) Set blood line and dialyzer to the machine to prime them with water.
(3) Set blood pump flow rate to 100mL/min and turn off [ON/OFF] SW of the pump.
(4) Put arterial line in water received in container.
(5) Put venous line in measuring cylinder.
(6) Press [ON/OFF] SW of blood pump to operate it at 100mL/min.
(7) Start stopwatch operation.

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(8) 3 minutes after the start, check that water level indication in measuring cylinder is
300mL±10%.
Error may be included in read water volume collected in the cylinder because the water
level is determined visually. Take care of this.

18.2.8. Check of accuracy of bubble sensor


18.2.8.1. Preferable method
(1) Required devices
Blood line, dialyzer, saline and micro-syringe (possible infusion of 0.05mL)
(2) Set blood line and dialyzer to the machine to prime them with saline.
(3) Turn on [ON/OFF] SW of blood pump to operate it at 200mL/min.
(4) Turn on [ON/OFF] SW of bubble sensor and check that BUBBLE is not alerted.
(5) Infuse about 0.05mL of air in line between venous drip chamber and bubble sensor
using micro-syringe under care for the air bubble is not divided.
(6) Check that BUBBLE is alerted at time when the bubble passes through the sensor.
(7) Check the following alarm functions:
z Audible alarm actuation
z Indication of alarm message in alarm screen
z Closing of clamp
z Stop of blood pump

18.2.8.2. Simple method


(1) Set water filled blood line to bubble sensor.
(2) Turn on [ON/OFF] SW of bubble sensor and check that BUBBLE is not alerted.
(3) Push the sensor by finger lightly and check that BUBBLE is alerted.
(4) Check the following alarm functions:
z Audible alarm actuation
z Indication of alarm message in alarm screen
z Closing of clamp
z Stop of blood pump

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18.2.9. Check of accuracy of temperature sensor
(1) Required devices
Calibrated thermometer and silicone tube
(2) Set calibrated thermometer at place near temperature sensor and check that difference
of the sensor indication in maintenance mode 1 screen from thermometer indication is
within ±0.8℃.
(3) Execute the above steps (2) and (3) to check accuracy of each of temperature sensors:
T1, T2 and T3.

NOTE
z Check the accuracy at low temperature (in water rinse process) and at high temperature
(in preparation end process).
z Place calibrated thermometer at position near temperature sensor (within 50cm).

Thermometer

Temperature sensor

Fig. 18.13 Setup to check accuracy of temperature sensor

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18.2.10 Check of accuracy of conductivity cell
(1) Required devices
Calibrated conductivity meter and silicone tube
(2) Place calibrated conductivity meter at place near conductivity cell.
(3) Prepare dialysate in dialysis mode.
(4) When dialysate conductivity indicated in dialysis or maintenance mode 1 screen is
stabilized, read the value and check that difference of the value from the meter value is
within ±0.2mS/cm.

NOTE
z Place calibrated conductivity meter at position near conductivity cell (within 60cm).

Calibrated conductivity
t

Fig. 18-14 Setup to check accuracy of conductivity cell

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

(1) Disassemble fluid supply ASSY.


(2) Remove foreign matters from mesh.
(3) Replace filter and packing with new ones yearly.

① Cap
② Hose port
③ Packing
④ Filter
⑤ Body

Fig 18-15 GVS filter ASSY

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18.2.12. Replacement of components of electromagnetic valve
(1) Required device
Phillips screwdriver
(2) Dislodge electromagnetic valve from frame.
(3) Remove screws from bottom of the valve to disassemble and replace body and plunger
ASSY
(plunger, diaphragm and seat) with new ones biyearly.

Plunger
Assy Body

Fig. 18-16 Two way electromagnetic valve(V2/V3/V12/V13/V14 (V15/V17) )

Diaphragm

Body

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Fig.18-17 Two way electromagnetic valve(V4/V11)

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Diaphragm Body

Fig. 18-18 Two way electromagnetic valve (V10)

Diaphragm

Bod

Diaphragm

Remove diaphragm by inserting tool with thin tip in gap between body and diaphragm to
defoliate it slowly from the body under care for the body is not damaged.

Fig. 18-19 Three way electromagnetic valve (V5/V6/V7/V8/V9)

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18.2.13. Replacement of component of pump
18.2.13.1. Overall views of pump

Fig. 18-20 Pump

18.2.13.2. Contents parts list


No Component Code No. NIPRO order code Note
1 Motor - -
2 Magnet ring - -
5 Rear casing - -
6 Magnet can - -
7 Mounting plate - -
8 Bracket - -
9 Drive gear - -
10 Slave gear - -
11 Gear case - -
12 Flat pin - -
13 Front bearing - -
14 Rear bearing - -
15 Front plate - -
16 Rear plate - -
17 Pump head - -
18 Gasket A - -
19 Gasket B - -

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20 Packing B - -
21 Packing C - -
22 Retinas spring - -
23 O-ring - -
31 Name plate - -
32 Small screw M3 × 20 with -
SW,PW
35 Small screw M3×16 -
36 Small screw M3×8 -
37 Hose port 93742611
38 Magnet gear MDG-R2RA115-3 -
pump 2A/MDG-R2RA23
0-33A

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18.2.13.3. Replace method
(1) Remove three small screws and then remove pump part from motor①.
(2) Remove four small screws and then remove pump head⑰
(3) Remove gasket A⑱.
(4) Remove three small screws and then remove mounting plate⑦, packing B⑳, bracket⑧,
gasket B⑲ from pump part
(5) Remove rear casing⑤. Keep on packing C to rear casing.(Be careful for remaining
some solution inside rear casing.)Rear casing⑤ can be removed by turning front
bearing⑬ and rear casing⑤. Pull rear bearing⑭ carefully keeping shaft of drive gear⑨
if rear bearing⑭ is remained inside rear casing⑤.
(6) Remove magnet ring② using tweezers and remove retinas spring.

Drive gear
Hang to magnet ring  CAUTION
● Remove magnet ring slowly and gently.
Magnet ring may change shape if pull
rough.
Magnet
ring Tweezers

Fig. 18-21

(7) Remove magnet can ⑥ from drive gear⑨. Do not allow dust stick to magnet can.
(8) Remove rear bearing⑭, rear plate⑯, drive gear⑨, slave gear⑩, gear case⑪, flat pin⑫,
front plate⑮, front bearing⑬ in this order. Take care for each component not to be
damaged.
(9) Attach front bearing⑬, rear bearing⑭ to O-ring. Paint silicon grease to O-ring before
attachment.
(10) Attach flat bearing⑫ to front bearing⑬. Assemble front plate⑮, gear case⑪, drive gear
⑨,
slave gear⑩, rear plate⑯, rear bearing⑭ in this order. Take care for each component is
fixed
hole position.
Insert direction of drive gear⑨ and slave gear⑩ as shown in Fig.18-22.

Drive gear⑨

To front To rear
bearing bearing

Slave Gear⑩

Fig. 18-22

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(11) Insert magnet can⑥ to drive gear⑨. Attach magnet ring② using tweezers as shown in
Fig.
18-23.

Tweezers  CAUTION
● Magnet ring may come off if it is fixed
Shrink in advance loosely. Shrink it before insert.
Drive gear ● Insert magnet ring surely to ditch of drive
Magnet ring
gear.

Fig. 18-23

(13) Insert retinas spring for fixing ditch of rear bearing⑭. Attach rear casing⑤ tightly.
When rear
casing ⑤ attach, do not turn it.
(14) Put on gasket A⑲ to front bearing⑬ for fixing hole position. Attach bracket⑧ for fixing
two
ditch of both parts.
(15) Attach gasket A⑱ to front bearing⑬. Assemble pump head⑰ using small screws.

Confirm direction

Confirm
 CAUTION
direction ● Check and adjust direction for gasket hole
⑱ and front bearing hole ⑬ straightly.
It causes of water leakage and malfunction
凸 part
凸 part if direction setting is failure.

凹 part 凹 part

Casing

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(16) Attach Packing B⑳ and mounting plate⑦ to bracket⑧ using small screws. Fixing
torque is
0.59N・m(6.0kgf・cm).
(17) Attach pump head⑰ using small screws. Fixing torque is 0.78N・m(8.0kgf・cm).
Fixing order is as shown in Fig. 18-24.

Fixing order
 CAUTION
● Screw part of front bearing may broke if
Pump head
irregular torque or only one side tightens
Small screw screw.

Fig. 18-24

(18) Attach pump part to motor① using small screws.

• Check and calibrate after changing Spear kit.


1) Priming water flow speed: Please see Service manual chapter 10.10. “Adjustment of
priming flow
rate.”
2) Dialysate flow speed: Adjust NV1.
3) Bypass flow speed: Please see Service manual chapter 10.11. “Adjustment of bypass flow
rate.”
4) Deaeration pressure: Please check it should be less than –600 mmHg at out of BT1. If it is
not enough, please check replacement procedure (11) had done correctly or not.

NOTE: following figure is Hot rinse option for SURDIAL


There is no special calibration for Hot rinse option.
Fig. Different between the standard and option parts.
Component Standard HEAT RINSE OPTION
Material color Material color
AS1 Float PP White PP + White with
Stainless metallic cap
P1/P2 *Front PPS Gray PPS Gray
bearing
*Rear PPS Gray PPS Gray
bearing
Drive Gear PPS Brown PEEK Black
Slave PPS Brown PEEK Black
Gear
*Note: Front/ Rear bearing are same parts as standard and option.
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18.3. Maintenance by qualified engineer
Fluid lines and Electrical units should be maintained by qualified engineer in accordance
with procedures specified in “Service Manual” at each time when 5000 hours are indicated in
hour meter or yearly whichever earlier.

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Chapter 19

STORAGE
1. Actions before storing machine
2. Environmental conditions required to store machine
3. Check and test before re-operation of machine

19.1 Actions before storing machine


19.1.1 Cleaning of enclosure
Clean enclosure of the machine by wiping with soft cloth wetted with alcohol or water.
DO NOT use solvent such as thinner and benzene. Otherwise painting may be damaged.

CAUTION
• DO NOT wipe the machine enclosure with disinfectant such as dilute NaClO solution.
Chlorine is generated by decomposition of NaClO. The gas is not only harmful for human
but also damages electric components significantly, resulting in failure of the machine.
• Clean and disinfect arterial and venous pressure inlet ports carefully to avoid cross
contamination among patients.

19.1.2 Priming of formalin solution


When the machine is stored for 5 days or more, prime fluid lines with 20% formalin
solution based on the following procedures to prevent microbial growth in the lines:
(1) Prepare 10L of 20% formalin solution in suitable container. If dilution is required,
use water of quality suitable for dialysis.
(2) Supply the solution using pump (not contained in the machine) capable of
supplying the solution at a flow rate of 2000 mL/min and at a water head of 5 to
15m.
(3) Use up prepared solution completely by additional water rinsing for about 20
minutes followed by storing the machine.

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19.2 Environmental conditions required to store machine
Store the machine at dust free place under avoiding direct exposure to sunlight.
Environmental conditions required to store the machine are shown below:

Storage without
Daily storage Storage for ≧1 month
fluid
Ambient temp.(°C) 10 - 40 5 - 50 -10 - 50
Relative humidity 15 - 85 15 - 85 15 - 85
(%) No condensing
Atmospheric pressure 795 - 1062 795 - 1062 795 - 1062
(hPa)

19.3 Check and test before re-operation of machine

CAUTION
• The check and test should be performed by well trained engineer having
knowledge how to maintain the machine. If incorrectly handled, troubles
such as fire and malfunction of the machine may be caused and abnormal
operation may be experienced in the next time use.

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) When the machine is used after long term of storage, perform disinfection and water
rinsing in sequence each for one hour or longer.
(2) Check no water leakage; abnormal sound and nasty smell; and abnormal indication
on operation panel during the disinfection and rinsing.
(3) Operate the machine under dialysis mode to check no UF related error.

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Chapter 20

MACHINE MOVING AND CAUTIONS


WARNING
z DO NOT place the machine at 5°or more against vertical line under loading any object on
container support or hanger to prevent falling down of the machine.
z DO NOT load any object on container support or hanger during transport of the machine.
z DO NOT place the machine at 10°or more against vertical line under loading any object
on container support or hanger t even under no loading to prevent falling down of the
machine.

(1) Release two locks (front right and rear left sides) placed at casters.
(2) Move the machine under holding it upright.
(3) Move the machine by pushing rear side of it. It is recommended to push rear side by
one person and to support front side by other person to guide because forward view of
the former person may be blocked by the machine.

Moving
di ti

Fig. 20-1 Moving of machine

20-1

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NOTE
z DO NOT move the machine on floor with irregular surface.
z If floor is stepped by ≧3 cm or is provided with groove of a width of ≧3 cm, place flat
plate such as steel plate capable of supporting the machine weight on the step or groove.
z Move the machine under contact of the four casters with floor.
z To move the machine on slope, direct front side of it upward. Move the machine by at
least 2 persons.

Moving direction Moving direction

Fig. 20-2 Upward movement Fig. 20-3 Downward movement

z Move the machine with care whether there is no obstacle on the way.
z To transport the machine by truck, hold the machine upright. DO NOT lay down the
machine.

(4) Follow the below procedures to lift the machine, if required:


Lift the machine by 4 persons.
Each of 3 of them should hold each leg of the machine frame as shown in Fig. 20-2.
The remainder one person should support rear side of the machine to prevent
falling down of it as shown in Fig. 20-2.

CAUTION
z DO NOT hold plastic cover. Hold frame.

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Fig. 20-4 Lift of machine

20-3

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Chapter 21

SPECIFICATIONS
21.1. Specifications for machine
21.1.1. Dimension and weight
Specifications Condition
Body dimension W: 450mm No
D: 600mm
H:1420mm (excluding IV pole)
H:1940mm (including IV pole)
Body mass 80kg (Dry mass) No

21.1.2. Power source


Specifications Condition

AC230V power supply


Voltage AC230V±10% No
Frequency 50Hz No
Cable length 3±0.1m No
(From rear side of machine to tip of
plug)
Power Machine : ≦1800W No
consumption (At rated power supply)
Heater : 1200W
(At AC230V, single phase)

AC110V power supply


Voltage AC110V±10% No
Frequency 50Hz No
Cable length 3±0.1m No
(From rear side of machine to tip of
plug)
Power Machine : ≦1800W No
consumption (At rated power supply)
Heater : 1200W
(At AC110V, single phase)

21.1.3. Electric safety


Specifications Condition

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Protective class Class 1, type B No
and type
21.1.4. Environment
Specifications Condition
2
Supply water 0.045 to0.74Mpa (0.5 to 7.5kgf/cm ) No
pressure (normal pressure)
Supply water flow ≧750mL/min At QD = 500mL/min
rate
17~30℃ At QD = 500mL/min
(5-30℃ if heat exchanger is used)
Supply water The temperature should be lower
Temperature than set dialysate temp. by ≧5℃.
The temperature fluctuation should
be within ±1℃/min.
Capacity:≧1500mL/min No
Drain
Height :0 to 60cm above floor
Spaces from circumference of No
machine should be:
Top ≧5cm
Sides ≧10cm
Spaces Rear ≧20cm
Ventilation port of diameter of ≧
20cm should be provided.
Any of top, sides and rear should
be exposed to atmosphere.
15~35℃ No
Ambient temperature (The temperature should be lower
than set dialysate temp. by ≧5℃.)
Ambient humidity 35-80% (no dew condensation) No
If fluid is in fluid lines : 5 to 50℃ No
Temperature during
If no fluid is in fluid lines: -10 to
Storage or transport
50℃
Humidity during 15~85% (no dew condensation) No
Storage or transport
Atmospheric 795 to 1062hPa at use, storage and No
Pressure transport
Quality meeting American National No
Standard for Haemodialysis System
Water quality
RD 5, 1981, Section 3.2 approved by
AAMI
Supply pressure MIN:Head below rinse port inlet by No
range of dialysate 136cm (-100mmHg)
Concentrate MAX:Head above rinse port inlet by

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136cm (+100mmHg)

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21.2. Performance of machine

21.2.1. Dialysate flow rate


Specifications Condition
Dialysate flow Min :300mL/min UFR is ≦2.70L/h when dialysate
Rate Rating:500mL/min flow rate is 300mL/min.
Max :600mL/min

21.2.2. Deaeration
Specifications Condition
Deaeration Negative pressure deaeration system No
System
Gas dissolved in Max:130mmHg When PO2 is 200mmHg after
dialysate deaeration at a water temp.
of 37℃.

21.2.3. UFR control


Specifications Condition
UFR control Closed capacity difference control by No
System VCS ( Viscous Control System)
Possible setting 0, 0.10~5.00L/h UFR is ≦ 2.70L/h when
Range dialysate flow rate is
300mL/min.
Accuracy of ±30g/h at a UFR of 0.10-5.00L/h If machine settings at release
UFR from factory are maintained

21.2.4. Temperature control


Specifications Condition
Possible setting 30.0~40.0℃ Supply water temp. should
Range (0.1℃ steps) be lower than set dialysate
temp. by ≧5℃.
Ambient temp. should be
lower than set dialysate
temp. by ≧5℃.
Accuracy of Indicated dialysate temp.: Mean temp.: Mean of
Indicated temp. Within mean temp.±0.8℃ dialysate temp. for one
minute

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21.2.5. Conductivity control (BICARBONATE)
Specifications Condition
Dialysate Fixed volume mixing by VCS (Viscous No
preparation Control System)
System
Possible input range A concentrate : 1/30.00 to 1/44.00 No
of dialysate
(at 0.01 steps of denominator)
concentrate dilution
ratio based on B concentrate : 1/14.00 to 72.00
concentrate supplier
(at 0.01 steps of denominator)
data
Possible input range A concentrate : 70 to 130 mmol/L No
of concentration
(at 1 mmol/L steps)
base on concentrate
supplier data B concentrate : 10 to 90 mmol/L
(at 1 mmol/L steps)

Possible setting A+W : 70 to 130mmol/L No


range of conductivity
(at 1mmol/L steps)
TOTAL : 130 to 160mmol/L
(at 1mmol/L steps)

21.2.6. Conductivity control (ACETATE)


Specifications Condition
Dialysate Fixed volume mixing by VCS (Viscous No
preparation Control System)
System
Possible input range 1/30.00 to 1/44.00 No
of dialysate (at 0.01 steps of denominator)
concentrate dilution
ratio based on
concentrate supplier
data
Possible input range 90 to 160mmol/L No
of concentration (at 1mmol/L steps)
base on concentrate
supplier data
Possible setting 90 to 160mmol/L No
range of conductivity (at 1mmol/L steps)

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21.2.7. Disinfection control
Specifications Condition

Disinfection system Fluid chemical disinfection No


system
Disinfectant preparation Fixed volume mixing by VCS No
control system ( Viscous Control System)
Concentration of Sodium hypochlorite: ≦6% No
disinfectant
Concentrate
Dilution ratio of Sodium hypochlorite Without temp. control
disinfectant …1/20 to1/300 Diluted concentration
Concentrate (at 1 steps of denominator) should be within 200 to
1000ppm.
Diluted concentrate should
be within 300ppm when
disinfection time is over 6
hours to 24 hours.
Setting of disinfection time 10-90min(at 5min steps) No

21.2.8. Acid rinse control


Specifications Condition
Acid rinse control system Fixed volume mixing by VCS No
( Viscous Control System)
Concentration of acetic Acetic acid: ≦50% No
acid concentrate
Dilution ratio of acetic acid Acetic acid: 1/6 to1/50 Without temp. control
Concentrate (at 1 steps of denominator) Diluted concentration
should be within 1 to 5%.
Setting of acid rinse time 10-90min(at 5min steps) No

21.2.9. Water rinse control


Specifications Condition
Setting of water rinse time 10-90min(at 5min steps) Without temp. control

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21.2.10. Blood pump
Specifications Condition

Blood pump Three roller type No


type
Manual gap adjustment
(range: 2.5 to 3.5 mm from housing
inside)
Flow rate range When large sized tube is used : Large sized tube:
30 to 500 mL/min (factory φ8.00 × φ12.00 ± 0.15 mm
set)
Length : ≥ 210 mm

Small sized tube:


When small sized tube is used :
φ 6.35 × φ 9.75 ± 0.15 mm
30 to 300 mL/min
Length : ≥ 210 mm

Accuracy of Set flow rate ± 10 % Min. inlet pressure :


flow rate -200 mmHg
Max. outlet pressure :
+500 mmHg

21.2.11. Syringe pump


Specification Required condition
Set infusion rate 0.1 to 9.9mL/h No

Accuracy of Mechanical error ±1% Nipro 20mL syringe


Infusion rate Infusion rate error ±10%
Overload Detection of overload: 54 to 60N When “2 Nipro 20mL
detection syringes” is set
Bolus infusion About 1800mL/h Nipro 20mL syringe
rate
Bolus infusion 0.5 to 5.0mL Nipro 20mL syringe
Volume 0.0mL: disabling of bolus infusion
Syringe pump 0 to 60min No
Operation stop 0min: disabling of the operation stop
Applicable Ones of cross-section ratio between 50 No
syringes and 200%
Nipro 20mL syringe: 100%

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21.3. Safety monitors

21.3.1. Venous pressure monitor


Specifications Condition
Possible setting range -400 to +400mmHg No
Possible indication Digital indication: No
range -400 to +400mmHg
Indicator indication:
…-200 to +400mmHg
Accuracy of indicated Actual pressure±10mmHg or Excluding indicator
Venous pressure ±10% (F.S.) whichever larger indication

21.3.2. Dialysate pressure monitor


Specifications Condition
Possible setting range -400 to +400mmHg No
Possible indication Digital indication: No
range -400 to +400mmHg
Indicator indication:
…-400 to +400mmHg
Accuracy of indicated Actual pressure±10mmHg or Excluding indicator
Value ±10% (F.S.) whichever larger indication

21.3.3. Bubble detector


Specifications Condition

Sensor type Ultrasonic detection type No


Applicable tube Material : soft PVC Use only NIPRO tube:
Outer diameter : φ 5.6 to 6.6mm 4.4×6.6 or 3.2×5.6
Detection capability Bubble of a size of ≥ 0.03 mL at Fluid temperature : 37°C
a flow rate of 200 mL/min

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21.3.4. Blood leak detector
Specifications Condition

Sensor type Optical detection type No


Detection Detection setting range : No
50 to 500 ppm (at 10ppm steps)
Detection point 300ppm : (Ht 20 %)
Alerting time 5 seconds after detection No

21.3.5. Temperature monitor


Specifications Condition

Sensor type Platinum resistance thermometer No


Sensor accuracy Actual temperature ± 0.5°C Sensor only
Fluid temp.: ≦40℃
Alarm limit Upper alarm limit :
setting
29.0 to 41.0 °C (at 0.1 °C steps)
Upper alarm limit accuracy :
Mean temp. ± 0.8 °C Mean of dialysate temp. for
one minute

Lower alarm limit :


29.0 to 41.0 °C (at 0.1 °C steps)
Lower alarm limit accuracy :
Mean temp. ± 0.8 °C

21.3.6. Conductivity monitor


Specifications Condition

Sensor type Electrode type No


Reproducibility ± 1% (F.S.) At 25°C
Alarm limit Automatic alarm limit setting: No
setting
Set conductivity ± 10% (max)
Manual alarm limit setting:
1 to 10% (at 1% steps)
No difference between set level and
actually detected level

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21.4. Specifications for options

21.4.1. Arterial pressure sensor


Setting arterial pressure sensor unit to the machine can monitor arterial pressure.

Specification Required condition


Allowable set range -400~+400mmHg No

Allowable indication Digital indication -400 to No


range +400mmHg
Indicator indication - -400 ~
+400mmHg
Accuracy of indicated Actual pressure±10mmHg、 Excluding indicator
Value or ±10% (F.S.) whichever greater

21.4.2. Backup unit of blood pump for power failure


Blood pump operation is enabled during power failure by setting backup unit of blood pump
for power failure to the machine.

21.4.2.1. Machine specification


Specification Condition
Blood pump flow 0 to 185mL/min Use of blood line:
rate during D=φ8.00×φ12.00±0.15mm
power failure L= ≧210mm

Full charge time ≧48 hours Time which is taken full


charged continuous power
on.

Continuous About 90 minutes at a flow rate of When new battery is full


operation time※ 185mL/ min Charged
※ The specification may not be satisfied according to battery and operation conditions.

21.4.2.2. Energy cell specification


Specification Condition
Type Ni-Cd battery No

Voltage 12V (1.2V×10) No

Capacity 1100mAh No

Ambient +15 to +35℃ No

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temperature
Ambient +35 to +80% No dew condensation
humidity

Storage/transpor Short term:-30~+80℃ No


t Long term (≧3 months):-30~+45℃
Temperature
Storage/transpor +15 to +85% No dew condensation
t
Humidity

21.4.3. Heat exchanger


Supply water temperature can be reduced by setting heat exchanger unit to the machine.

21.4.4. Acid rinse port unit


Acetic acid rinsing is enabled by setting acid rinse port to the machine.

21.4.5. Hot rinse Assy


Change from normal parts inside machine to hot rinse parts.
Hot rinse parts need to execute hot water rinse, hot chemical disinfectant rinse at 50℃.

CAUTION
● Do not use disinfectant concentrate which is not suitable of using by heat. (For example,
acetic acid)

21.4.5.1. Hot chemical disinfectant rinse control


Specifications Condition

Disinfection system Fluid chemical disinfection No


system
Disinfectant preparation Fixed volume mixing by VCS No
control system ( Viscous Control System)
Temperature setting 38-42℃⇔43-47℃⇔48-52℃ Supply water temperature
which is required to rise at
50℃
With heat exchanger
Water temperature : >4℃

Without heat exchanger


Water temperature : >26℃

Rising time to setting


Temperature is approx.

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30minutes

Setting of disinfection time 10-90min(at 5min steps) No

21.4.5.2. Hot water rinse


Temperature setting 38-42℃⇔43-47℃⇔48-52℃ Supply water temperature
which is required to rise at
50℃
With heat exchanger
Water temperature : >4℃

Without heat exchanger


Water temperature : >26℃

Rising time to setting


Temperature is approx.
30minutes

Setting of disinfection time 10-90min(at 5min steps) No

21.4.6. Large single lump Assy


Change from normal single lump to large one.

21.5. Special note


21.5.1. Language
English
Spanish

21-12

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Chapter 22

DATA FOR USE

22.1 Blood tubing set applicable to SURDIAL


22.1.1 A065(A067) / V643

Trade name Model

NIPRO BLOOD TUBING SET A065(A067) / V643

Arterial tube
MODEL№ A065(A067) TYPE (A)

①Lure cap ⑦Level adjusting line


②Revolving lock connector ⑧Arterial drip chamber
③Shunt joint line ⑨Saline infusion line
④Robert clamp ⑩Rolling tube
⑤Main tube ⑪Heparin infusion line
⑥Arterial pressure monitor line ⑫Main tube

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Venous tube
MODEL№ V643 TYPE (V)

①Main tube ⑤Main tube


②Venous pressure monitor line ⑥Robert clamp
③Level adjusting line ⑦Shunt joint line
④Venous drip chamber ⑧Revolving lock connector

22.1.2 A064(A066) / V643

Trade name Model

NIPRO BLOOD TUBING SET A064(A066) / V643

Arterial tube
MODEL№ A064(A066) TYPE (A)

①Lure cap ⑦Level adjusting line


②Revolving lock connector ⑧Arterial drip chamber
③Shunt joint line ⑨Saline infusion line
④Robert clamp ⑩Rolling tube
⑤Main tube ⑪Heparin infusion line
⑥Arterial pressure monitor line ⑫Main tube

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Venous tube
MODEL№ V643 TYPE (V)

①Main tube ⑤Main tube


②Venous pressure monitor line ⑥Robert clamp
③Level adjusting line ⑦Shunt joint line
④Venous drip chamber ⑧Revolving lock connector

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22.2 Layouts of blood tubing
22.2.1 Model A065(A067) / V643

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22.2.2 Model A064(A066) / V643

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22.3 Flow chart and components of SURDIAL
22.3.1 Flow chart

ACID

2)Dotted line and < > mean option.


) )
6 5
F F
( (

1)Blood lines is not included.


T T DISINFECTANT or ACID
U > U
O 7 O
2
1 1
V V
N
I < N
I
B_concentrate

) A_concentrate or Acetate
2
T
U F
O
1 (T
1 U
T
U )
V O
3 O
4 3
N
I 1 1 F
(
T NV NV 2 5
N U
O
I I L V VLS
I S N D L
S B C
P 2 4
V V
R
MS
3 2 FF
V D
R T 3
B T
1 1 V
S D D P
A T C
B
M
1 5 7 O
P 2 VC
O
VO
C 9 C
N N N N V O C R
C a 12
b3 4
1 N
N E
P
HH
PP M M
O
HH
P PP C S
V
O
C C V P 2 Y
a b
S
L L
W C C 1 A
T V V R I
B D
M M
O
C
O
C 1 7
C F
O C C O D
2 6N
N 8N
N
P
1 T V V
V
R
1
H S
L
C
N PP
1
I
3 BB
V D V >
N L 2 A
B T
U
O V 2 P
R P <
2
2 C
1 T R P
T U N
I 2
O
W S P3
) S A SS
L
> 4 8 F
X V F
E (
H
<
N T
I U
O
FROM PATIENT

TO PATIENT

F 0 3
1 R
V
T
U
O 1
R
P
N
I
DRAIN
1 2 D
RO WATER Z Z E
B B R
Lamp

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22.3.2 Component of SURDIAL

Symbo Component Symb Component Symbo Component


l ol l
T1 Temperature sensor V6 EMV for drainage from C1 Dialysate check valve
1 VCa
T2 Temperature sensor
2
T3 Temperature sensor V7 EMV for fresh fluid C2 Bellowphragm check
3 VCb valve
CD Conductivity cell V8 EMV for drainage
PD Dialysate pressure from VCb F Supply water filter
sensor V9 EMV for bypassing <F2> Filter for A
dialysate concentrate
<PA> Arterial pressure <F3> Filter for B
sensor concentrate
V10 EMV for gas <F5> Filter for disinfectant
discharge
PV Venous pressure V11 EMV for rinse <F6> Filter for acid
sensor V12 EMV for disinfectant F7 Filter for coupler line
BLD Blood leak sensor concentrate <F8> Filter for V4 line
LS1 Temperature limit SW V13 EMV for A FM Flow meter
concentrate
LS2 Coupler SW V14 EMV for B NV1 Priming flow rate
concentrate control valve
LS3 Syringe overload SW <V17> EMV for acetic acid
LS5 Clamp position concentrate NV2 Dialysate flow rate
sensor control valve
PH1 VPa original point P1 Deaeration pump
sensor P2 Dialysate pump PC1 Bypass pinch clamp
PH2 VPa rotation CLV Venous clamp PC2 AS2 pinch clamp
detection sensor Vpa Bellowphragm pump PR Supply water
A reducing valve
PH3 VPb original point VPb Bellowphragm pump
sensor B
H Heater R1 Flow rate limiting
PH4 VPb rotation BP Blood pump connector 1
detection sensor SP Syringe pump R2 Flow rate limiting
PS Pressure SW BZ1 Buzzer 1 connector 2

FS Closed line flow BZ2 Buzzer 2 R3 Flow rate limiting


sensor connector 3
FSW Float SW Lamp Lamp RV1 Relief valve 1

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Symbo Component Symb Component Symbo Component
l ol l
BPC Blood pump cover AS1 Deaeration bath 1 RV2 Relief valve 2
SW
BD Bubble detector AS2 Deaeration bath 2 RV3 Relief valve 3
V2 EMV for priming BTW Buffer tank W RV4 Relief valve 4
V3 EMV for drainage BTD1 Buffer tank D1 SL Sampling port
V4 EMV for AS2 BTD2 Buffer tank D2 VCa Viscous chamber A
V5 EMV for fresh VCb Viscous chamber B
fluidVCa
<HEX> Heat exchanger

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