Nipro surdial x руководство

• Page 1
  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…
• Page 2
  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.
• Page 3
  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 Remove blood and/or organic substances from…

• Page 4: Table Of Contents

  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 ･･････････････････････････････････････････････････････････ 6.1.1. Ambient conditions ･･･････････････････････････････････････････････････････････････…

• Page 5
  ･･･････････････････････････････････････････････ 6.4.2. Connection of each concentrate ･････････ 6.4.2.1. Connection to execute dialysis operation(before blood line connection) ･･････････････････････････････････････････････ 6.4.2.2. Connection for water rinsing ････････････････････････････････････････････････ 6.4.2.3. Connection for disinfection ･････････ 6.4.2.4. Connection for acetic acid rinsing (when acid rinse option is not used) 6-10 ････････････…
• Page 6
  ･･･････････････････････････････････････････････････････････････････････ 9. DISPLAY 9-1~18 ･･･････････････････････････････････････････････････････････････ 9.1. Layout of display ････････････････････････････････････････････････････････････････ 9.2. Wake up screen ･･･････････････････････････････････････････････････････････････････ 9.3. Rinse screen ････････････････････････････････････････････････････････････････ 9.3.1. Rinse menu ･･････････････････････････････････････････････････････････････････ 9.3.2. Rinse wait ････････････････････････････････････････････････････････ 9.3.2.1. RINSE1: WATER ･････････････････････････････････････････････････････ 9.3.2.2. RINSE2:CHEMICAL ･････････････････････････････････････････････････････ 9.3.2.3. RNSE3:AUTO1 C&D ･･･････････････････････････････････････････････････ 9.3.2.4. RINSE4: AUTO2 C&D ･････････････････････････････････････････････････････････････…
• Page 7
  ･････････････････････････････････････････････････ 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 ･････････････････････････････････････…
• Page 8
  ･･････････････････････････････････････････････････････ 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 ･･･････････････････････････････････････････････…
• Page 9
  ････････････････････････････････････････････････････ 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 ･････････････････････････････････････････････････････････…
• Page 10
  ････････････････････････････････････････････････････ 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 ････････････････････････････････････････････････････…
• Page 11
  ･････････････････････ 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.
• Page 12
  ･･･････････････････････････････････････ 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 ･･････････････････････…
• Page 13
  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 ･･････････････････････････････････････････････････…

• Page 14: Cautions For Safety ･･･････････････････････････････････････････････････ Caution-1~6

  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.
• Page 15
  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.
• Page 16
  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.
• Page 17
  ■ 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.
• Page 18
  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 ■…
• Page 19
  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.

• Page 20: Contraindication

  Chapter 2 CONTRAINDICATION Any application other than dialysis is contraindicated.

• Page 21: Cautions ･･････････････････････････････････････････････････････････････････････ 3-1~2

  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;…

• Page 22
  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.

• Page 23: Definitions

  “Blood line” means the circuit used to circulate extracorporeal blood through dialyzer. “Blood pump” means pump used to circulate blood through dialyzer and blood line. Roller type pump is used in SURDIAL. “Bubble detector” means device used to detect air bubble in blood passing through venous line.

• Page 24
  excess fluid are removed. DIALYSIS screen : PREPARATION COMPLETION, DIALYSIS and RECOVERY are enabled by the mode. “Disinfection” means process to disinfect dialysate line by passing disinfectant such as dilute sodium hypochlorite or peracetic acid solution through it. “Disinfectant concentrate connection port” means that provided with male connector used to connect with disinfectant.
• Page 25
  “Viscous pump” means bellowphragm pump receiving viscous silicone used to control ultrafiltration (UF) and to prepare dialysate. “Water rinsing” means process to rinse dialysate line by passing water through it.
• Page 26
  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.
• Page 27
  5. SPECIFICATIONS Specification Required condition -400～+400mmHg Allowable set range Allowable indication Digital indication -400 range +400mmHg -400 ～ Indicator indication +400mmHg Actual pressure±10mmHg、 Accuracy of indicated Excluding indicator or ±10％ (F.S.) whichever greater value…

• Page 28: Installation

  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.

• Page 29: Necessary Space Requirements To Use The Machine

  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 ≧…

• Page 30: Concentrate Line Pressure

  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.

• Page 31: Unpacking And Check Of Contents

  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.

• Page 32
  (f) Blood pump handle (×1) (g) Coupler set (×1) 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…

• Page 33: Procedure For Assembling

  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.

• Page 34: Connector For Each Concentrate Container

  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…

• Page 35: Procedures For Tube And Plug Connections

  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”…

• Page 36: Connection Of Each Concentrate

  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.

• Page 37: Connection For Acetic Acid Rinsing (When Acid Rinse Option Is Not Used)

  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.

• Page 38: Air Purge

  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. …

• Page 39: Disinfection Of The Dialysate Circuit

  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.

• Page 40: Main Functions And Components ････････････････････････････････････････････ 7-1~2

  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…

• Page 41: Construction Of Machine ･･･････････････････････････････････････････････････ 8-1~14

  Chapter 8 CONSTRUCTION OF MACHINE 8.1 Overall construction 8.1.1 Overall views Main Operation Blood line setting Front view Right side Fig. 8-1-1 Front and right side views of SURDIAL…
• Page 42
  Power supply Rear side view Left side view Fig. 8-1-2 Rear and left side views of SURDIAL…

• Page 43: Components Of Machine And Their Purposes And Functions

  8.1.2 Components of machine and their purposes and functions Component Purpose and function Sampling port Port used to take dialysate sample Rinse port Port used to connect to connector of A concentrate concentrate container during rinsing operation Connector Connector used to connect connector of bicarbonate A concentrate concentrate container Rinse…

• Page 44
  Component Purpose and function Water supply port Port used to connect hose for supplying purified water to the machine Drain port Port used to connect hose for draining used dialysate Port for connector of Port connect connector disinfectant disinfectant concentrate concentrate container when disinfectant or acid rinsing connector is not executed…

• Page 45: Operation Panel

  8.2 Operation panel 8.2.1 Construction of operation panel Fig. 8-2 Operation panel…

• Page 46: Components Of Operation Panel And Their Purposes And Functions

  8.2.2 Components of operation panel and their purposes and functions Component Purpose and function [DIALYSIS] SW with lamp SW used to start dialysis “During dialysis preparation” and “enabled dialysis start” is indicated by lamp lighting. [PREP.] SW with lamp SW used to prepare dialysate and to prepare to start air purge “Preparation end”…

• Page 47
  Component Purpose and function lower limit SW used to increase set lower VP limit within increasing SW acceptable range lower limit SW used to decrease set lower VP limit within decreasing SW acceptable range 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.
• Page 48
  Component Purpose and function Set left time increasing SW SW used to increase displayed left dialysis time digitally Set left time decreasing SW SW used to decrease displayed left dialysis time digitally FUNCTION 1 SW SW used to set various parameters Set data is indicated in message screen.

• Page 49: Blood Line Setting Panel

  8.3 Blood line setting panel 8.3.1 Construction of blood line setting panel Fig. 8-3 Blood line setting panel…

• Page 50: Components Of Blood Line Setting Panel And Their Purposes And Functions

  8.3.2 Components of blood line setting panel and their purposes and functions Component Purpose and function Blood pump rotor Rollers used to deliver blood by squeezing blood line tube Blood pump cover Cover used to protect rotating mechanism of BP BP operation stop is caused by opening cover.

• Page 51
  8.4 Power supply 8.4.1 Construction of power supply Fig. 8-4 Power supply 8-11…

• Page 52: Power Box

  8.4.2 Components of power supply and their purposes and functions Component Purpose and function Power cord Cord having power plug at its distal end Power SW Power SW of the machine Buzzer Buzzer used to alert error audibly DC24V OUT Service connector for manufacture RS-232C Service connector for manufacture…

• Page 53: Main Lamp Assembly

  8.5 Main lamp assembly 8.5.1 Construction of main lamp assembly Fig. 8-5 Main lamp assembly 8-13…

• Page 54: Components Of Main Lamp Assembly And Their Purposes And Functions

  8.5.2 Components of main lamp assembly and their purposes and functions Component Purpose and function Main lamp Lamp used to alert error visually Hanger Hanger used to suspend vial and the like I.V. pole Pole used to hold dialyzer and the like Set screw Screw used to fix hanger to I.V.

• Page 55: Display

  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.)

• Page 56
   ＣＡＵＴＩＯＮ LCD is easily damaged. Do not press or scratch its surface by pencil point or any hard tool. LCD is mainly constructed by glass. Do not give impact to it. Do not press operation panel SW by pencil point or any hard tool.

• Page 57: Layout Of Display

  9.1. Layout of display Areas from①to⑨are allocated to LCD screen to display information specified for each of them. ① ② ③ ④ ⑤ ⑥ ⑦ ⑧ ⑨ Fig. 9.2 Layout of display ① Title display area Title of currently selected mode is displayed. ②…

• Page 58
  preparation, preparation end, dialysis, recovery) and various setting screens (settingⅠ, settingⅡ, maintenance) are displayed.
• Page 59
  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…

• Page 60: Wake Up Screen

  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 check result ROM check result  ＣＡＵＴＩＯＮ…

• Page 61: Rinse Screen

  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…

• Page 62: Rinse Wait

  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.

• Page 63: Rinse4: Auto2 C&D

  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…

• Page 64: Rinse Execution

  9.3.3 Rinse execution During rinse progress, rinse step at that time is displayed. Displayed information is defined by selected rinse mode. ＮＯＴＥ 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.

• Page 65
  Fig. 9-12 Rinse execution screen when RINSE4 is selected 9-11…

• Page 66: Rinse End

  9.3.4 Rinse end During rinse end process, rinse result is displayed. Displayed information is defined by selected mode. ＮＯＴＥ 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.

• Page 67: Dialysis Screen

  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.

• Page 68: Priming

  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］…

• Page 69: Test Mode

  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 Display of BP test result by OK or NG…

• Page 70: Settingⅰ Screen

  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］…

• Page 71: Settingⅱ Screen

  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］…

• Page 72: Maintenance Menu Screen

  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.

• Page 73: Alarm Screen

  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…

• Page 74: Alarm Functions And Resetting

  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.

• Page 75: Procedure For Resetting

  (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. Dialysate pressure release or air removal from dialysate When dialysate pressure exceeds preset level, it is alerted and the pressure is released automatically.

• Page 76: Table Of Alarms

  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).

• Page 77
  Part of alarms may be reset by release of the alarm from detection condition. 10-4…

• Page 78: Table Of Alarms ･･･････････････････････････････････････････････････････ 10-3~14

  10.2.2 Table of alarms Alarm Detection Detection Fluid line Alarm Alarm name Audible alarm Resetting and note condition process function close release stop •Rinse ○(3 times) ― ― ― RECOVER FROM Return to normal after Execution of Automatic return to normal •Preparation EMERGENCY STOP power failure caused…

• Page 79
  Alarm Detection Detection Fluid line Alarm Alarm name Audible alarm Resetting and note condition process function close release stop ○(3 times) ― ― ○ DIALYSATE Dialysate temperature (T3) Dialysis 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…
• Page 80
  Alarm Detection Detection Fluid line Alarm Alarm name Audible alarm Resetting and note condition process function close release stop •Rinse wait •○(7 times) ○ ― ○ VENOUS PRESSURE MIN Venous pressure of UF stop Return to normal by pressing [RESET] SW •Rinse LIMIT ≦-400mmHg…
• Page 81
  Alarm Detection Detection Fluid line Alarm Alarm name Audible alarm Resetting and note condition process function close release stop •Dialysis wait Arterial pressure of ≧set ○(Continuous) ○ ― ○ ARTERIAL PRESSURE UF stop Return to normal by pressing [RESET] SW •Preparation MAX ALARM Becoming error free of set upper and lower…
• Page 82
  Alarm Detection Detection Fluid line Alarm Alarm name Audible alarm Resetting and note condition process function close release stop •Preparation ○(Continuous) ― ― ― HEATER OVER HEAT Functioning of «LS1» Heater OFF Return to normal by pressing [RESET] SW •Preparation end ALARM placed at heater outside •Dialysis…
• Page 83
  Alarm Detection Detection Fluid line Alarm Alarm name Audible alarm Resetting and note condition process function close release stop •Rinse wait •○(７times) ― ○ ― ― CLV POSITION ERROR Abnormal clamp position Return to normal by pressing [RESET] SW •Rinse •Same as above Return to normal by BP/SPSW-ON SW-OF…
• Page 84
  Alarm Detection Detection Fluid line Alarm Alarm name Audible alarm Resetting and note condition process function close release stop ○(７times) ― ― ― ○ VPa CLOSED CIRCUIT Insufficient positive Rinse(water Return to normal by pressing [RESET] SW LEAK ERROR pressure in A chamber rinse) Possible alarm release in maintenance No arrival at set pressure…
• Page 85
  Alarm Detection Detection Fluid line Alarm Alarm name Audible alarm Resetting and note condition process function close release stop •Rinse wait •○(７times) ― ― ― ― RAM ERROR RAM error Return to normal by pressing [RESET] SW •Rinse •Same as above Error detection only when power SW is ON •Rinse end •Same as above…
• Page 86
  Alarm Detection Detection Fluid line Alarm Alarm name Audible alarm Resetting and note condition process function close release stop •Rinse wait •○(７times) ― ― ― ― EEPROM INITIALIZE EEPROM initialization Return to normal by pressing [RESET] SW •Rinse •Same as above Error detection only when power SW is ON •Rinse end •Same as above…
• Page 87
  Alarm Detection Detection Fluid line Alarm Alarm name Audible alarm Resetting and note condition process function close release stop •Rinse wait •○(７times) ― ― ― ○ BP BATTERY ERROR BP backup battery voltage Return to normal by pressing [RESET] SW •Rinse of ≦8.5V •Same as above…
• Page 88
  Alarm Detection Detection Fluid line Alarm Alarm name Audible alarm Resetting and note condition process function close release stop ○(3 times) ― ― ― ― NO WATER RINSING Shift dialysis wait Dialysis wait Return to normal by pressing [RESET] SW process without executing Return to normal by water rinsing for water rinse for specified…

• Page 89: Cleaning And Disinfection

  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.

• Page 90: Disinfection Of Fluid Line Inside

  DANGER 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.

• Page 91: Method To Set Dilution Rate Of Disinfectant Concentrate

  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″…

• Page 92: Removal Of Calcium Deposit From Fluid Line Inside

  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 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.

• Page 93: Method To Set Dilution Rate Of Acetic Acid Concentrate

  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″…

• Page 94: Process Flow

  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.

• Page 95: Description Of Process Flow

  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.

• Page 96: Rinse End Process

  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.

• Page 97: Operation Of Machine

  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 If non-conformance can not be corrected, DO NOT operate the machine. Paint out □…

• Page 98
  Paint out □ Item to be checked Fluid supply and drainage □OK □NG ・ All tubes and lines such as supply and drain tubes should be free from damages such as folding and bending. □OK □NG ・ Water supply pressure should be 0.049 ～ 0.74MPa (0.5 ～ □OK □NG 7.5kgf/cm…
• Page 99
  Paint out □ Item to be checked Residual disinfectant □OK □NG ・ Residual disinfectant should not be detected by testing drain water using reagent or test paper. ※ Use copies of these sheets for daily check of the machine. 13-3…

• Page 100: Procedures For Machine Operation

  13.2 Procedures for machine operation 1. Turn on power breaker of the machine. 2. Execute prerinsing operation. 3. Execute dialysis. Execute postrinsing. 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.

• Page 101: Dialysis

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

• Page 102: Rinsing

  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 Execute rinsing operation before and after dialysis. To execute disinfection/rinse or acid rinse, read Chapter 11. Read optional manual before use of hot water rinse or hot chemical disinfectant rinse.

• Page 103: Selection Of Rinsing Mode

  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…

• Page 104: Connection Of Concentrates

  14.3 Connection of concentrates  ＣＡＵＴＩＯＮ Connect each concentrate connector and rinse port securely. If not so, troubles such as water leak and air aspiration may be caused. 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.

• Page 105: Connection Of Concentrates When Acid Port Unit (Option) Is Used

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

• Page 106: Start Of Rinsing (Example: Rinse4(Auto2 C&D)

  14.4 Start of rinsing (example: RINSE4(AUTO2 C&D)） (5) Check rinsing pattern. (6) Check concentrate connection. (7) Press [RINSE] SW. [RINSE] SW lamp is ON. Rinsing is started. Rinsing progress is displayed in screen. ［ＲＩＮＳＥ４］ ２１：００ ＜ Ｒｉｎｓｅ ＞ ＷＴＲ００→ＣＨＭ１５→ＤＷＬ３０→ＰＲＥ３０ ＰＲＥＲＩＮＳＥ ＳＴＡＲＴ ＴＯＭＯＲＲＯＷ…

• Page 107: Discontinuance Of Rinsing

  14.6 Discontinuance of rinsing (1) Press [DIALYSIS] SW. [RINSE] SW lamp is OFF. [DIALYSIS] SW lamp is ON. Dialysis screen is displayed.  ＷＡＲＮＩＮＧ Rinsing can be discontinued at any step during the operation. DO NOT execute dialysis after rinsing is discontinued. Disinfectant or acid may be left in the machine.

• Page 108: Double Needle Dialysis

  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.

• Page 109: Setting Of Dialysate Related Parameters

  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.

• Page 110: Acetate Dialysate

  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…

• Page 111: Connection Of Concentrates

  15.2. Connection of concentrates  ＣＡＵＴＩＯＮ Connect each concentrate connector and rinse port securely to prevent troubles such as water leak and air aspiration. Use A and B concentrates for preparing bicarbonate dialysate and acetic acid concentrate for preparring acetate dialysate of specified concentrations. 15.2.1.

• Page 112: Setting Of Blood Line, Dialyzer And Syringe

  (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 (292.5mm ) as 100% and set the ratio.

• Page 113
  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.

• Page 114: Setting Of Syringe Operation Stop Time

  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)».

• Page 115
  15-8…

• Page 116: Preparation Of Machine (Preparation Process)

  15.4. Preparation of machine (preparation process) (1) Press [F･5] SW to display dialysis screen. (2) Press [PREP.] SW once. [PREP.] SW lamp is flashing. [BYPASS] SW lamp is flashing. Dialysate preparation is started. 15.5. Check of preparation completion of machine (preparation end process) (1) Check that [PREP.] SW lamp is ON.

• Page 117: Priming Process

  15.6. Priming process  ＣＡＵＴＩＯＮ Follow instruction of dialyzer manufacturer to know “which should be preceded blood or dialysate compartment when dialyzer is primed”. 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.

• Page 118: Priming Of Dialyzer With Dialysate

  (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.

• Page 119: When Priming Function Is Not Used

  (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.

• Page 120: Check Of Dialysate Conductivity

  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.

• Page 121: Connection Of Patient

   ＣＡＵＴＩＯＮ 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.

• Page 122: Start Of Dialysis (Dialysis Process)

  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.

• Page 123: Setting Of Upper And Lower Dialysate Pressure Alarm Limits

  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.

• Page 124: Completion Of Dialysis (Recovery Process)

  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 “ » is alerted. PREFORMED TARGET UF (2) Check conformance of «UF GOAL»…

• Page 125: Execution Of Blood Recovery

  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.

• Page 126: Clearing Away

  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.

• Page 127: Discontinuance Of Dialysis

  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. [PREP.] SW lamp is ON. [UF DIALYSE] SW lamp is OFF.

• Page 128: Single Needle Dialysis

  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.

• Page 129: Setting Of Dialysate Related Parameters

  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.

• Page 130: Acetate Dialysate

  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…

• Page 131: Connection Of Concentrates

  16.2. Connection of concentrates  ＣＡＵＴＩＯＮ Connect each concentrate connector and rinse port securely to prevent troubles such as water leak and air aspiration. Use A and B concentrates for preparing bicarbonate dialysate and acetic acid concentrate for preparing acetate dialysate of specified concentrations. 16.2.1.

• Page 132: Setting Of Blood Line, Dialyzer And Syringe

  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.

• Page 133: Setting Of Syringe Pump

  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 (292.5mm ) 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.

• Page 134: Setting Of Syringe Operation Stop Time

  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)».

• Page 135: Preparation Of Machine (Preparation Process)

  16.4. Preparation of machine (preparation process) (1) Press [F･5] SW to display dialysis screen. (2) Press [PREP.] SW once. [PREP.] SW lamp is flashing. [BYPASS] SW lamp is flashing. Dialysate preparation is started. 16.5. Check of preparation completion of machine (preparation end process) (1) Check that [PREP.] SW lamp is ON.

• Page 136: Priming Process

  16.6. Priming process  ＣＡＵＴＩＯＮ Follow instruction of dialyzer manufacturer to know “which should be preceded blood or dialysate compartment when dialyzer is primed”. 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.

• Page 137: Priming Of Dialyzer With Dialysate

  (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.

• Page 138: When Priming Function Is Not Used

  (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.

• Page 139: Check Of Dialysate Conductivity

  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.

• Page 140: Connection Of Patient

   ＣＡＵＴＩＯＮ 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.

• Page 141: Setting Of Single Needle Dialysis Related Parameters

  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>.

• Page 142: Start Of Dialysis (Dialysis Process)

  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.

• Page 143: Setting Of Upper And Lower Dialysate Pressure Alarm Limits

  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.

• Page 144: Completion Of Dialysis (Recovery Process)

  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 “ » is alerted. PREFORMED TARGET UF (2) Check conformance of «UF GOAL»…

• Page 145: Execution Of Blood Recovery

  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.

• Page 146: Clearing Away

  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.

• Page 147: Discontinuance Of Dialysis

  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. [PREP.] SW lamp is ON. [UF DIALYSE] SW lamp is OFF.

• Page 148: Sequential Dialysis

  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.
• Page 149
  is not failure of the machine. 17-2…

• Page 150: Check And Maintenance

  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 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.

• Page 151: Cleaning And Disinfection Of Machine Outside

  (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：…

• Page 152: Regular Check By Engineer

  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.

• Page 153: Check Before Power On

  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.

• Page 154: Check Of Leakage Current

  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=10kΩ…

• Page 155: Check Of Accuracy Of Pressure Sensor

  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 displayed pressure from manometer reading should be within ±…

• Page 156: Check Of Syringe Pump

  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 Required device Syringe Connect syringe to syringe pump as shown in Fig.

• Page 157: Check Of Accuracy Of Uf

  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. Advance plunger of syringe connected to venous pressure inlet port through tube to pressurize to about +50mmHg and keep the pressure.

• Page 158: Check Of Accuracy Of Blood Leak Sensor

  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.

• Page 159: Zero Revisions Of Blood Leak Sensor

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

• Page 160: Check Of Accuracy Of Blood Pump Flow Rate

  Adjustment volume １ 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.

• Page 161: Check Of Accuracy Of Bubble Sensor

  (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.

• Page 162: Check Of Accuracy Of Temperature Sensor

  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℃.

• Page 163: Check Of Accuracy Of Conductivity Cell

  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.

• Page 164: Replacement Of Components Of Gvs Filter (Supply Water Line)

  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 18-15…

• Page 165: Replacement Of Components Of Electromagnetic Valve

  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…

• Page 166
  Fig.18-17 Two way electromagnetic valve（V4/V11） 18-17…
• Page 167
  Diaphragm Body Fig. 18-18 Two way electromagnetic valve (V10) Diaphragm 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.

• Page 168: Replacement Of Component Of Pump

  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 Component Code No. NIPRO order code Note － － Motor － － Magnet ring － － Rear casing － － Magnet can －…

• Page 169
  － － Packing B － － Packing C － － Retinas spring － － O-ring － － Name plate × － with Small screw SW,PW － M3×16 Small screw － M3×8 Small screw Hose port 93742611 － Magnet gear MDG-R2RA115-3 pump 2A/MDG-R2RA23 0-33A…

• Page 170: Replace Method

  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…

• Page 171
  (11) Insert magnet can⑥ to drive gear⑨. Attach magnet ring② using tweezers as shown in Fig. 18-23.  CAUTION Tweezers ● Magnet ring may come off if it is fixed Shrink in advance loosely. Shrink it before insert. ● Insert magnet ring surely to ditch of drive Drive gear Magnet ring gear.
• Page 172
  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.

• Page 173: Maintenance By Qualified Engineer

  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. 18-24…

• Page 174: Storage

  Chapter 19 STORAGE Actions before storing machine Environmental conditions required to store machine 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.

• Page 175: Environmental Conditions Required To Store Machine

  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 Storage for ≧1 month Daily storage fluid Ambient temp.(°C) 10 — 40 5 — 50 -10 — 50…

• Page 176: Machine Moving And Cautions

  Chapter 20 MACHINE MOVING AND CAUTIONS  ＷＡＲＮＩＮＧ 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. DO NOT load any object on container support or hanger during transport of the machine. 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.

• Page 177
  ＮＯＴＥ DO NOT move the machine on floor with irregular surface. 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. Move the machine under contact of the four casters with floor.
• Page 178
  Fig. 20-4 Lift of machine 20-3…

• Page 179: Specifications

  Chapter 21 SPECIFICATIONS 21.1. Specifications for machine 21.1.1. Dimension and weight Specifications Condition Ｗ： 450mm Body dimension Ｄ： 600mm Ｈ：1420mm (excluding IV pole) Ｈ：1940mm (including IV pole) Body mass 80kg (Dry mass) 21.1.2. Power source Specifications Condition AC230V power supply AC230V±10％…

• Page 180: Environment

  Protective class Class 1, type B and type 21.1.4. Environment Specifications Condition Supply water 0.045 to0.74Mpa (0.5 to 7.5kgf/cm (normal pressure） pressure ≧750mL/min Supply water flow 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 than set dialysate temp.

• Page 181
  136cm (+100mmHg) 21-3…

• Page 182: Performance Of Machine

  21.2. Performance of machine 21.2.1. Dialysate flow rate Specifications Condition ：300mL/min UFR is ≦2.70L/h when dialysate Dialysate flow Rating：500mL/min Rate flow rate is 300mL/min. Max ：600mL/min 21.2.2. Deaeration Specifications Condition Deaeration Negative pressure deaeration system System Max：130mmHg Gas dissolved in When PO is 200mmHg after dialysate…

• Page 183: Conductivity Control

  21.2.5. Conductivity control (BICARBONATE） Specifications Condition Dialysate Fixed volume mixing by VCS (Viscous preparation Control System) System Possible input range A concentrate : 1/30.00 to 1/44.00 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…

• Page 184: Disinfection Control

  21.2.7. Disinfection control Specifications Condition Disinfection system Fluid chemical disinfection system Disinfectant preparation Fixed volume mixing by VCS control system ( Viscous Control System) Sodium hypochlorite: ≦6% Concentration of disinfectant Concentrate Dilution ratio Sodium hypochlorite Without temp. control …1/20 to1/300 disinfectant Diluted concentration…

• Page 185: Blood Pump

  0.5 to 5.0mL Nipro 20mL syringe Volume 0.0mL: disabling of bolus infusion Syringe pump 0 to 60min Operation stop 0min: disabling of the operation stop Applicable Ones of cross-section ratio between 50 syringes and 200% Nipro 20mL syringe: 100% 21-7…

• Page 186: Safety Monitors

  Condition Sensor type Ultrasonic detection type 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 Bubble of a size of ≥ 0.03 mL at Detection capability Fluid temperature : 37°C…

• Page 187: Blood Leak Detector

  21.3.4. Blood leak detector Specifications Condition Sensor type Optical detection type Detection Detection setting range : 50 to 500 ppm (at 10ppm steps) Detection point 300ppm : (Ht 20 %) Alerting time 5 seconds after detection 21.3.5. Temperature monitor Specifications Condition Sensor type Platinum resistance thermometer…

• Page 188: Specifications For Options

  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 -400～+400mmHg Allowable set range Allowable indication Digital indication -400 range +400mmHg -400 ～ Indicator indication +400mmHg Actual pressure±10mmHg、 Accuracy of indicated Excluding indicator or ±10％…

• Page 189: Heat Exchanger

  temperature +35 to +80％ Ambient No dew condensation humidity Short term：-30～+80℃ Storage/transpor Long term (≧3 months)：-30～+45℃ Temperature +15 to +85％ Storage/transpor No dew condensation Humidity 21.4.3. Heat exchanger Supply water temperature can be reduced by setting heat exchanger unit to the machine. 21.4.4.

• Page 190: Hot Water Rinse

  30minutes Setting of disinfection time 10-90min（at 5min steps） 21.4.5.2. Hot water rinse Supply water temperature Temperature setting 38－42℃⇔43－47℃⇔48－52℃ 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.

• Page 191: Data For Use

  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 ①Lure cap ⑦Level adjusting line ②Revolving lock connector ⑧Arterial drip chamber ③Shunt joint line…

• Page 192: A064(A066) / V643

  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 ①Lure cap ⑦Level adjusting line ②Revolving lock connector ⑧Arterial drip chamber…

• Page 193
  Venous tube MODEL№ V643 TYPE ①Main tube ⑤Main tube ②Venous pressure monitor line ⑥Robert clamp ③Level adjusting line ⑦Shunt joint line ④Venous drip chamber ⑧Revolving lock connector 22-3…

• Page 194: Layouts Of Blood Tubing 22.2.1 Model A065(A067) / V643

  22.2 Layouts of blood tubing 22.2.1 Model A065(A067) / V643 22-4…

• Page 195: Model A064(A066) / V643

  22.2.2 Model A064(A066) / V643 22-5…

• Page 196: Flow Chart And Components Of Surdial

  22.3 Flow chart and components of SURDIAL 22.3.1 Flow chart ACID DISINFECTANT or ACID B_concentrate A_concentrate or Acetate DRAIN RO WATER 22-6…

• Page 197: Component Of Surdial

  22.3.2 Component of SURDIAL Symbo Component Symb Component Symbo Component Temperature sensor EMV for drainage from Dialysate check valve Temperature sensor Temperature sensor EMV for fresh fluid Bellowphragm check valve Conductivity cell EMV for drainage from VCb Dialysate pressure Supply water filter…

• Page 198
  Symbo Component Symb Component Symbo Component BPC Blood pump cover Deaeration bath 1 RV2 Relief valve 2 Bubble detector Deaeration bath 2 RV3 Relief valve 3 EMV for priming BTW Buffer tank W RV4 Relief valve 4 EMV for drainage BTD1 Buffer tank D1 SL Sampling port EMV for AS2…

More Medical Equipment Device Models:

Recommended Documentation: