1. Manuals
  2. Brands
  3. Terumo Manuals
  4. Medical Equipment
  5. CAPIOX EBS Circuit with X coating
  6. Instructions for use manual

Terumo CAPIOX EBS Circuit with X coating Instructions For Use Manual

Emergency bypass system
Hide thumbs
Table of Contents

Advertisement

Quick Links

®
CAPIOX
Emergency Bypass System
Instructions for use

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the CAPIOX EBS Circuit with X coating and is the answer not in the manual?

Questions and answers

Related Manuals for Terumo CAPIOX EBS Circuit with X coating

Summary of Contents for Terumo CAPIOX EBS Circuit with X coating

  • Page 1 ® CAPIOX Emergency Bypass System Instructions for use...
  • Page 2 Indications for Use The CAPIOX Emergency Bypass System (EBS) is authorized to be used by healthcare providers (HCP) in the hospital setting for providing long-term (> 6 hours) respiratory or cardiopulmonary support to treat patients 18 years or older with Coronavirus Disease 2019 (COVID-19) who have acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.
  • Page 3 Disclaimers  The CAPIOX EBS has neither been cleared or approved for providing long-term (> 6 hours) respiratory or cardiopulmonary support to treat patients 18 years or older with Coronavirus Disease 2019 (COVID-19) who have acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent;...
  • Page 4 ® CAPIOX EBS™Circuit with X coating™ Instructions for use...
  • Page 5 2019-XX ™ Circuit with X coating Instructions for Use Please read this Instructions for Use carefully before use, and use this product according to the instructions described here.
  • Page 6 Symbols on the packages of this product Symbols Instructions Catalogue number Batch code Use-by date Manufacturer Consult instructions for use Do not re-use Do not resterilize Sterilized using ethylene oxide Keep away from sunlight Keep dry Fragile, handle with care Do not use if package is damaged Temperature limit This way up...

  • Page 7: Table Of Contents

    Contents/Description of Product Contents Contents/Description of Product Contents Description of Product Structure Warnings/Precautions Precautions for operation 5 - 6 Precaution for storage Instructions for Use Set up 7 - 9 Priming procedure 10 - 12 Connection Initiation of BYPASS During perfusion 14 - 16 Termination of BYPASS Circuit replacement...

  • Page 8: Structure

    Structure Structure...

  • Page 9: Warnings/Precautions

    WARNINGS/PRECAUTIONS Precautions for operation ・ Adequate heparinization of the blood is required to WARNINGS prevent blood coagulation in the system. ・Never clamp the venous line (blue) during circulation. Otherwise, pressure inside of the pump will turn into negative, which is a potential hazard of producing gas bubbles.

  • Page 10: Precaution For Storage

    ・Do not use if the unit package or the product has been damaged or soiled. Use it immediately after opening the unit package and dispose of it safely after use. ・Spare pack of CAPIOX EBS Circuit should be available for emergency exchange.

  • Page 11: Instructions For Use

    Instructions for Use Thoroughly read “Warnings/Precautions” (Page 4 - 5) before use. Instructions for use Set Up 1. Set a holder and a drive motor. ・Fix the drive motor to the holder tightly with screws for t h e drive motor (Figure 1). 2.
  • Page 12 ・Make sure that the underside of the centrifugal CAUTIONS pump is in close contact with the pump receptacle and that the slide hook is in position (Figure 6). ・ Make sure that the rim of back side of the oxygenator and the hook of the exclusive holder are connected to the slide hook (Figure 7).
  • Page 13 10. After the circuit was assembled, confirm all parts are connected properly, and the tubes are not folded or kinked. 11. When using with CAPIOX SP Console SP-101: Attach the CAPIOX SP Pump Flow Sensor 3/8” to the flow connector on the arterial line following the Instructions for Use of CAPIOX SP Pump Console SP-101.

  • Page 14: Priming Procedure

    Priming procedure ・This product should be primed with crystalloid sol u ti o n CAUTIONS which contains no blood, plasma and/or blood derived products. ・In case of adding blood or plasma, etc. in the pri m i n g solution, after priming, follow the procedure below. ・Infuse blood or plasma, etc.
  • Page 15 8. Press the Auto-Priming button or the icon of the applicable centrifugal pump controller. The Auto-Priming function works on the centrifugal pump to turn intermittently. The procedure to expel bubbles in the circuit through microporous of the oxygenator is automatically performed. CAUTION Do not operate the centrifugal pump without filling it with priming solution.
  • Page 16 14. Turn the motor rpm adjustment knob to “0” and stop the rotation of the pump. 15. Pulling up the slide hook of the drive motor, remove the centrifugal pump from the drive motor (Figure 14). After confirming that the centrifugal pump has been thoroughly primed and there is nothing wrong with it, set the pump to the drive motor again.

  • Page 17: Connection

    Connection Close clamps of the arterial line (red) and venous line (blue) from over the clean cover (Figure 15). Remove the clean cover pulling from the corner (Figure 16). Figure 15 Loosen each screw wing for the arterial line and the venous line to remove the bypass connector (Figure 17).

  • Page 18: Initiation Of Bypass

    Initiation of BYPASS WARNINGS ・ Prior to starting circulation, confirm that priming line is closed as well as 3-way stopcocks for removing bubbles and those of the sampling port. If the 3-way stopcocks are not closed, bubbles may enter the circuit as the pressure inside the venous line (blue) is negative during circulation.
  • Page 19 CAUTIONS ・ Carefully adjust the pump speed to control the blood flow, because the blood flow varies depending on the load applied to the pump (the patient's arterial pressure, resistance of the circuit). ・ Control blood flow by adjusting the pump speed. Partially clamping the outlet of the pump to control the blood flow may increase the blood damage.

  • Page 20: Termination Of Bypass

    • During circulation, always carefully monitor the patient blood condition and the oxygenator gas exchange performance. If gas exchange performance deteriorates, temporarily raise the gas flow rate to flush the inside of the fiber and try to recover performance. The gas flow rate for flushing is 20 L / min, the time is 10 seconds.

  • Page 21: Circuit Replacement

    Circuit replacement CAUTIONS ・Always prepare the spare circuit for emergency replacement. ・Exchange all of the circuit when a problem occurs in the oxygenator or the centrifugal pump. ・All procedures must be aseptically performed. 1. Perform priming procedure with the spare applicable centrifugal pump controller or the backup controller.

  • Page 22: Data

    Data transfer <Conditions> :Bovine Blood Blood :12±1g/dL :7.4 SvO2 :65±5% PvCO2 :45±5mmHg B.E. :0±5mEq/L :1.0 Blood Temperature:37±1℃ Blood flow rate(L/min) transfer <Conditions> :Bovine Blood Blood :12±1g/dL :7.4 SvO2 :65±5% PvCO2 :45±5mmHg B.E. :0±5mEq/L :1.0 Blood Temperature:37±1℃ Blood flow rate(L/min) Heat exchanger performance factor <Conditions>...

  • Page 23: Specifications

    Specifications Specifications XSA0171 XSA0173 XSA0251 Code number Ethylene oxide gas Sterilization 620mL 620mL 740mL Priming volume 550 mL SL45 SL45 SL45 Centrifugal pump SP45 Maximum blood flow rate 7 L/min Minimum blood flow rate 0.5 L/min Maximum pressure 1000 mmHg (133 kPa) Connector for venous cannula Lock connector Connector for arterial cannula...

  • Page 24: Limited Warranty

    TERUMO Corporation warrants that the product has been manufactured and packaged with reasonable care, and will be free from defects under normal and proper use. TERUMO Corporation will not be liable for any direct or indirect, incidental, special, general or consequential loss, damage, or expense from the use of this product.
  • Page 25 2019-XX , EBS and X coating are trademarks of TERUMO CORPORATION.
  • Page 26 ® CAPIOX EBS Cannula Kit™ with X coating™ Instructions for use...
  • Page 27 Product overview/Name of each part This product is a kit consisting of cannulas to connect to a blood circuit for extracorporeal circulation to send or drain blood after percutaneously inserting cannulas into blood vessels and supporting tools for catheterization. This product is composed of one cannula, one dilator, one entry needle, one guide wire, predilators (8 Fr., 12 Fr.), one syringe and one scalpel.
  • Page 28 heparinized saline injection or sampling is required, pull out only the guide wire and perform the required procedure by ● While holding the cannula, slowly pull out the guide wire and the dilator. When they are pulled out to the point of the clamping tube using the dilator hub (Figure 7).
  • Page 29 ® CAPIOX Centrifugal Pump Controller SP-200 Instructions for use...
  • Page 30 2016-02 ® Centrifugal Pump Controller SP-200 Instructions for use Store this instruction manual in a convenient location for future reference whenever necessary. Read the instructions carefully before using the product, and operate in accordance with instructions. Perform maintenance and inspections to ensure safe use and extend the life of this product.
  • Page 31 Read this instruction manual carefully to fully understand this product and ensure its safe use. Conduct safety training sessions for this product before use. For an explanation regarding the introduction of this product, consult with Terumo’s service representative. Contents Confirming the Setup ........48 Purpose, Overview and Features of the Product —...
  • Page 32 SP-200 Maintenance/Inspection Check Configuration of the Controller and List ............129 Network Equipment ........78 Maintenance and Inspection Items by Terumo’s Setting of the Controller ......79 Service Representative ........131 Specification of Network Communication Periodic Inspection ........131 (Format) ............ 79 Replacement Parts ........

  • Page 33: Purpose, Overview And Features Of The Product

    Purpose, Overview and Features of the Product Purpose and Overview This product is a drive system for operating a disposable centrifugal pump which mainly perfuses blood in the blood circuit of the heart-lung machine. Product Features  Excellent operability and visibility •...

  • Page 34: Parts Description

    Parts Description System Configuration Example (When Attached on the Cart) Gas cylinder Infusion bags CAPIOX centrifugal pump Hand Crank CAPIOX Circuit with X coating Gas blender Drive Motor Controller Cart • For information on the attaching method, refer to “Attaching the Controller to the Cart” (page 29) and “Attaching Other Products to the Cart”...

  • Page 35: Controller

    Parts Description Controller  Front view Status lamp Handle Indicates the operating status of this Used when carrying the Controller. system through changes in colour. Green (lights up): indicates the system is operating normally. Yellow (lights up): indicates the system has detected a low priority alert.
  • Page 36 Parts Description  Rear view ® port Connects to the CDI500. LAN port Connects with a LAN cable. USB port Connects with a USB memory drive. Pressure sensor connector (P1 and P2) Connects with the Pressure Fast clamp connector Connects with the Fast Clamp. Sensor Cable.

  • Page 37: Device Behaviour In Relation To The Coast Speed

    Parts Description Device Behaviour in Relation to the Coast Speed As the motor speed slows and reaches coast speed (*), the system maintains that motor speed. This is to avoid back flow of circulation if users further decrease the motor speed. In order to decrease the motor speed to less than the coast speed, confirmation (coast release) is required.

  • Page 38: Lcd Touch Panel Display (When Operating Normally)

    Parts Description LCD Touch Panel Display (When Operating Normally)  Main screen * When you tap each function, you can directly proceed to the corresponding Setup screen. Number Name Description Displays the count up time of the count up timer 1 (date: two digits, hour: two Count up timer indicator (1) digits, minute: two digits, second: two digits).
  • Page 39 Parts Description Number Name Description Displays the circulating flow with a bar. The set thresholds of the High Flow Flow bar indicator Alarm/Low Flow Alarm are indicated with “  ”. Displays the motor speed of the Drive Motor. Motor speed indicator Displays the perfusion index value by inputting height and weight in the BSA Perfusion index indicator setup.
  • Page 40 Parts Description Number Name Description Displays the setup conditions of the air bubble detector function, the status of ABD status icon the alarm and the setup conditions of the safety connection. The setup conditions and the status of the alarm Displays the setup conditions of the safety connection at the left side of the icon.

  • Page 41: Lcd Touch Panel Display (When Issuing Alarm)

    Parts Description LCD Touch Panel Display (When Issuing Alarm) Message area Of the issued alarms, the message is When you tap , you displayed from the high priority message in can scroll up and down the order of the corresponding priority. When you message area to view all of the tap each message, the information about the issued alarm messages.

  • Page 42: Display Units Of The Controller

    Parts Description Display Units of the Controller In this manual, units are written corresponding to the Controller display as follows: Display on Description (unit) the LCD touch panel display Flow Liters per minute (L/min) Motor Speed Rotations per minute (r/min) Optional Accessories Standard accessories supplied with this system: ●...
  • Page 43 Parts Description  ABD/Flow Sensor Product name: CAPIOX Centrifugal Pump Controller SP-200 ABD/Flow Sensor Manufacturer: Transonic Japan (Catalogue number: ME * SPFAS01 (for standard tube circuit), ME * SPFAS02 (for soft tube circuit)) An ultrasonic transmission sensor and a receiving sensor are built in. The flow is measured by the ultrasonic transit method, and air bubbles are detected by the change in the ultrasonic receiving level.
  • Page 44 Parts Description  Pressure Sensor Cable (Catalogue number: XX * SPCBL021) When measuring pressure, connect the pressure sensor which complies with the ANSI/AAMI BP22:1994 to the Controller. The pressure sensors MP5100 (TW) and MP5200 (TW) made by Edwards Lifesciences Corporation are recommended for use. Pressure sensor Plug connector...
  • Page 45 Parts Description  Fast Clamp Arm (Catalogue number: XX * SPCLP02) When securing the Fast Clamp, use this fixture with flexible arm. The Fast Clamp can be attached in multiple configurations because of the flexible arm type.  Fast Clamp Attachment (for EBS) (Catalogue number: XX * SPCLP01) When securing the Fast Clamp, use this fixture with the CAPIOX EBS Circuit Holder.
  • Page 46 Parts Description  Cart (Catalogue number: XX * SPCRT01) The entire system can be mounted on this cart. Since infusion bags, gas cylinders and gas blenders can also be attached, the cart can support transportation during extracorporeal circulation. IV pole Cylinder holder Handles Basket (for accessory)
  • Page 47 Parts Description  Related components • CAPIOX centrifugal pump • CAPIOX EBS Circuit with X coating • CAPIOX Luer Thermistor • CDI System 500 • Pressure sensor (complied with ANSI/AAMI BP22:1994) * Limited to those that can be connected to connectors.

  • Page 48: Precautions

    Precautions To ensure safe and correct use of this product, please observe all precautions. Non-compliance with precautions and incorrect use may result in damage or injury. The following are symbols used in this manual and their meanings: This label preceding a precaution indicates that there will be a possible risk of death or Warning personal injury if the precaution given is not complied with.
  • Page 49 Precautions Warnings • When installing the system in an ambulance and transferring a patient in the event of an emergency, make sure the power supply of the ambulance is always higher than the total consumption power for all electric devices installed. [If the supply power of the ambulance becomes insufficient, the device shuts down and circulation cannot be maintained.] (Controller) •...
  • Page 50 If any abnormality is found, do not use this system. [This may result in decreased performance.] Contact Terumo’s service representative for inspection and repair. • If this system is used in a cardiac catheterization laboratory, ICU, CCU or chest operating room, connect the system to the centralized ground centre.
  • Page 51 Precautions Cautions • Since this system does not have an airtight structure, it should not be used or stored in an active gas environment (including sterilizer gas), nebulizer-sprayed environment, high-humidity environment, etc. [Taking the system to these environments leads to the electronic components inside the system being affected and there may be subsequent damage and time degradation which will cause failure of this system.] •...
  • Page 52 Precautions Cautions • When used in the vicinity of an electrosurgical knife (Medical radio knives are surgical equipment for incision and coagulation by high energy radio frequency current), it may cause malfunction due to the noise of high-frequency current. Check the following before use. (1) Electrosurgical knives have a different level of high-frequency noise emission depending on the types.
  • Page 53 Precautions Cautions (Hand Crank) • When using the Hand Crank, attach it to a pole securely after ensuring there is enough space and tube length so that the crank can rotate smoothly. [It may become impossible to maintain circulation.] • Do not exceed the maximum motor speed of 3000 RPM. [This may cause problems to the centrifugal pump or blood damages may occur.] •...

  • Page 54: Storage

    Precautions Storage Cautions • Do not expose this system to direct sunlight or ultraviolet irradiation for a long period of time. [The exterior may experience colour change, deformation or deterioration.] • Do not store this system in a place with a high level of vibration, dust, mist or corrosive gas. •...

  • Page 55: Precautions Regarding Installation On Ambulance

    Precautions Precautions Regarding Installation on Ambulance Warning • When installing the system in an ambulance and transferring a patient in the event of an emergency, make sure the power supply of the ambulance is always higher than the total consumption power for all electric devices installed. [If the supply power of the ambulance becomes insufficient, the device shuts down and circulation cannot be maintained.] Caution •...

  • Page 56: Operation Procedure

    If any abnormality is found, do not use this system. This may result in decreased performance. Contact Terumo’s service representative for inspection and repair. When Using for the First Time Connect to the AC power supply and charge (6 hours or more) with the power turned off until the charge lamp turns off.

  • Page 57: Preparation Before Use

    Operation Procedure Preparation Before Use The preparation steps prior to using are shown below. Prepare the Necessary Devices  page 29 Attach the Controller to the Cart  page 29 Connect to AC Power Cable  page 31 Connect to Drive Motor ...

  • Page 58: Preparing The Necessary Devices

    Operation Procedure Preparing the Necessary Devices Prepare the following devices. ● Controller ● AC power cable ● Drive Motor ● ABD/Flow Sensor ● Applicable centrifugal pump ● Vaseline ● Applicable blood circuit (including oxygenator, etc.) ● Priming solution Prepare the following devices if necessary. ●...
  • Page 59 Operation Procedure Pull the lever of the Cart in the direction of the arrow. (Figure 1-3 a) Align the rubber feet of the front side of the Controller Rubber feet with the Cart guide, and place the Controller on the Cart. (Figure 1-3 b) Note Lever...

  • Page 60: Connecting To Ac Power Cable

    Operation Procedure Connecting to AC Power Cable Warning • Connect the AC power cable to the AC power inlet of the Controller until you hear a click. Subsequently, check that the AC power lamp in the control panel of the Controller is lit. If the connection is insufficient, the Controller will be powered by the battery.
  • Page 61 Operation Procedure Insert the AC power cable into the AC power inlet until you AC power inlet hear a click. (Figure 1-5) When it is fully inserted, the AC power cable is locked in the AC power inlet. Check • The AC power cable will not disconnect even if you pull it toward you while holding the connector of the AC power cable.

  • Page 62: Connecting To Drive Motor

    Operation Procedure Connecting to Drive Motor Caution • Do not use this system with products other than those listed in “Optional Products” (refer to page 13).  Using the CAPIOX EBS Circuit Holder Remove the pole clamp attached to the Drive Motor with a Drive Motor screwdriver (+).
  • Page 63 Operation Procedure Attach the CAPIOX EBS Circuit Holder to the IV pole of the Cart and secure it with the knob. (Figure 1-9) IV pole Check • The CAPIOX EBS Circuit Holder is secured. Knob CAPIOX EBS Circuit Holder Figure 1-9 Remove the plug cap of the Drive Motor.
  • Page 64 Operation Procedure Remove the plug cap of the Drive Motor. Insert the Drive motor connector plug into the drive motor connector on the rear panel. (Figure 1-12 a) Then, turn the lock ring clockwise until you hear a click. (Figure 1-12 b) When removing the plug of the Drive Motor, turn the lock ring counter- clockwise until you hear a click, and pull it out straight.

  • Page 65: Connecting To Abd/Flow Sensor

    Operation Procedure Connecting to ABD/Flow Sensor When using the air bubble detector function, confirm that the setup of the air bubble detector function is on. (Refer to “Confirming the Setup” (page 48).) 1. Insert the plug of the ABD/Flow Sensor into the ABD/Flow ABD/Flow sensor connector sensor connector on the rear panel until you hear a click.

  • Page 66: Connecting To Temperature Sensor Cable

    Operation Procedure Connecting to Temperature Sensor Cable This section describes the step for using the temperature measuring function. When using the temperature measuring function, confirm that the setup of the temperature measuring function of the channel to be used is on. (Refer to “Confirming the Setup” (page 48).) 1.

  • Page 67: Connecting To Fast Clamp

    Operation Procedure When removing the plug, pull it out straight while holding the outer ring of the Plug plug of the Pressure Sensor Cable. (Figure 1-18) Figure 1-18 Connecting to Fast Clamp This section describes the steps for using the Fast Clamp. When using the Fast Clamp, confirm that the setup of the Fast Clamp is on.
  • Page 68 Operation Procedure Attach the Fast Clamp to the Fast Clamp Attachment Fast Clamp (for EBS) (Figure 1-21 a), and secure it with the knob. (Figure 1-21 b) Check • The Fast Clamp is secured. Fast Clamp Attachment (for EBS) Knob Figure 1-21 Hang the cable of the Fast Clamp along the cable clamps.
  • Page 69 Operation Procedure  Using the Fast Clamp Arm Confirm that the knobs (two places) of the Fast Clamp Arm Knob are secured. (Figure 1-25) Fast Clamp Arm If the knobs are not secured, the Fast clamp holder may move and it may cause the Fast Clamp fall when you attach the Fast Clamp.

  • Page 70: Inspection Before Use

    Operation Procedure When removing the plug, pull it out straight while holding the outer ring of the Plug plug of the Fast Clamp. (Figure 1-29) Figure 1-29 Inspection Before Use Perform the prior-to-use inspection by following “Inspection Before Each Use” (Refer to page 122).

  • Page 71: Preparing Circulation

    Operation Procedure Preparing Circulation The preparation steps for circulation are shown below. Centrifugal Pump Connection to the Tube Pack  page 43 Attach the Centrifugal Pump to the Drive Motor  page 43 Attach the ABD/Flow Sensor  page 44 Use the temperature measuring...

  • Page 72: Centrifugal Pump Connection To The Tube Pack

    • Do not use this system with any centrifugal pump other than the dedicated centrifugal pump (CAPIOX centrifugal pump, CAPIOX centrifugal pump as the component product of the CAPIOX EBS Circuit with X coating). If a centrifugal pump other than the dedicated centrifugal pump is used, this may result in decreased performance.

  • Page 73: Attaching The Abd/Flow Sensor

    Operation Procedure Cautions WRONG • Do not operate the centrifugal pump without filling the pump with liquid beforehand. Damage may occur to the rotary sliding part. Centrifugal pump • When attaching or detaching the centrifugal pump to or from the Drive Motor, confirm that the Drive Motor is stopped.
  • Page 74 Operation Procedure Attach the clamp-on ABD/Flow sensor to the blood circuit Clamp-on ABD/Flow sensor tube. (Figure 1-35, Figure 1-36) Fully insert the blood circuit tube into the detection window of the clamp-on ABD/Flow sensor. Tube Direction of circulation Figure 1-35 Caution CORRECT •...

  • Page 75: Attaching The Temperature Sensor (Capiox Luer Thermistor)

    Operation Procedure Close the lid of the clamp-on ABD/Flow sensor. (Figure 1-37) Press the lid until you hear a click. Figure 1-37 Attaching the Temperature Sensor (CAPIOX Luer Thermistor) This section describes the step for using the temperature measuring function. When using the temperature measuring function, confirm that the setup of the temperature measuring function of the channel to be used is on.

  • Page 76: Turning The Power On

    Operation Procedure Turning the Power On Press the power button. (Figure 1-40) Power button Figure 1-40 The LCD touch panel display is lit, and the Controller is activated. After the start screen is displayed with an activation sound, the main screen appears.

  • Page 77: Confirming The Setup

    Operation Procedure Confirming the Setup Tap the setup icon on the main screen. (Figure 1-42) Figure 1-42 Tap the Alarm Setup List icon. (Figure 1-43) Figure 1-43 Confirm the on/off setup of the various functions, the alarm threshold value and the setup of the safety connection. (Figure 1-44) Figure 1-44 Note...

  • Page 78: Auto-Priming

    Operation Procedure Auto-priming You can perform the priming easily by using the auto-priming function. Caution • When priming, if a significant amount of air enters the centrifugal pump causing the pump to idle, stop the rotation of the pump. Remove the air and start priming again. Start the auto-priming after filling the priming solution.

  • Page 79: Calibration Of The Pressure Sensor

    Operation Procedure Notes • Auto-priming setting (on time/off time/motor speed) can be changed. For details about how to set, refer to “Setting Auto-priming” (page 106). • When 30 minutes have passed after starting the auto-priming, the auto-priming will automatically stop and “Auto-priming Stopped”...

  • Page 80: Attaching The Fast Clamp

    Operation Procedure After confirming the message displayed and expose the pressure sensor to the air, tap [OK]. (Figure 1-50) Calibration of the pressure sensor is started. Figure 1-50 When calibration has been finished normally, “0” will be displayed at the side of [CAL].
  • Page 81 • If the lever does not return to the original position, pull down the lever. If it does not return to the original position, a failure may have occurred. Stop using the system immediately, and contact Terumo’s service representative. Lever Figure 1-52 Release the latch of the Fast Clamp lid, and open the lid.
  • Page 82 Operation Procedure Close the lid of the Fast Clamp, and close the latch. (Figure 1-55) Check • The clamp ready lamp is lit in green. Latch Clamp ready lamp Figure 1-55  Using the Fast Clamp Arm Holding the Fast Clamp by hand, loosen the knob of the Fast Clamp Arm by turning it counter-clockwise Knob (Figure 1-56 a), and then move the Fast Clamp to any...
  • Page 83 • If the lever does not return to the original position, pull down the lever. If it does not return to the original position, a failure may have occurred. Stop using the system immediately, and contact Terumo’s service representative. Lever Figure 1-58 Release the latch of the Fast Clamp lid, and open the lid.

  • Page 84: Inspection Before Circulation Starts

    Operation Procedure Close the lid of the Fast Clamp, and close the latch. (Figure 1-61) Check • The clamp ready lamp is lit in green. Latch Clamp ready lamp Figure 1-61 Inspection Before Circulation Starts Perform the inspection before circulation starts by following “Inspection Before Circulation Starts (Before Each Use)”. (Refer to page 125.) Starting Circulation Cautions...

  • Page 85: During Circulation

    Operation Procedure During Circulation Warnings • Monitor the circulation status (the operation status of the system, blood storage state of a reservoir, etc.) during extracorporeal circulation without fail. 1. As this system does not have a function to monitor the status of the patient, the system cannot detect when the status of the patient changes even if the system operates properly.

  • Page 86: Weaning

    Operation Procedure Weaning Cautions • When weaning, be sure to clamp the blood line and then stop the rotation of the centrifugal pump. If the rotation of the centrifugal pump stops without clamping the blood line, blood may flow back. •...

  • Page 87: Turning The Power Off

    Operation Procedure Tap [Clamp] (Figure 1-66) to close (up position) the plunger of the Fast Clamp. Note • Perform with the tube attached. Figure 1-66 Tap [Cancel] to close the screen. (Figure 1-67) Figure 1-67 Turning the Power Off Press the power button. (Figure 1-68) Power button Figure 1-68 Tap [OK] after confirming the message displayed.

  • Page 88: Using The Cart

    Operation Procedure Using the Cart Casters Lock all casters of the Cart with each stopper. (Figure 1-70) Stopper Caution Lock • Keep the cartʼs casters in a locked position except when transporting the cart. The Cart may move unintentionally, causing attached products to fall. Figure 1-70 IV Pole Adjust the height (maximum: about 1.7 m) of the IV hanger, and secure it with the...

  • Page 89: Cable Hook

    Operation Procedure Cable Hook Wind the cable (AC power cable, etc.) around the cable hooks. (Figure 1-72) AC power cable Cable hooks Figure 1-72 Drawer The drawer has a lock mechanism to prevent popping out. Pull forward the lock release plate to open the drawer. (Figure 1-73) To close the drawer, push the drawer back until you hear a click.

  • Page 90: Moving The Cart

    Operation Procedure Moving the Cart Move the Cart by holding the handles with the caster locks released. (Figure 1-74) Handles Caster Casters Figure 1-74 Attaching Other Products to the Cart Attach the following products to the Cart with its casters locked. To secure the products to the IV pole, attach it below the level of the IV pole knob.

  • Page 91: Attaching The Oxygen Cylinder

    Operation Procedure IV pole Gas blender Figure 1-76 Attaching the Oxygen Cylinder Attach the cylinder holder to the rear side pole, and secure Cylinder holder it with the knobs. (Figure 1-77) Check Knobs • The cylinder holder is secured. Pole Figure 1-77 Place the oxygen cylinder into the cylinder holder.

  • Page 92: Attaching The Capiox Ebs Circuit Holder

    Operation Procedure Attaching the CAPIOX EBS Circuit Holder Attach the CAPIOX EBS Circuit Holder to the IV pole, and secure it with the knob. (Figure 1-79) IV pole Attach it on the opposite side of the cylinder holder. Check • The CAPIOX EBS Circuit Holder is secured. Knob CAPIOX EBS Circuit Holder Figure 1-79...

  • Page 93: Attaching The Hand Crank

    Operation Procedure Attaching the Hand Crank Attach the Hand Crank to the IV pole, and secure it with the Hand Crank knob. (Figure 1-81) IV pole Knob Caution • When using the Hand Crank, attach it to a pole securely after ensuring there is enough space and tube length so that the crank can rotate smoothly.

  • Page 94: Other Operation Procedures

    Other Operation Procedures This section describes the following functions. Function Function description Reference Safety connection Sets up the behaviours responding to the Pressure Alarm (over pressure/  page 65 low pressure), the Air Bubble Detected Alarm and the Back Flow Alarm. Battery-powered operation Runs the Drive Motor on a battery if the AC power supply fails.

  • Page 95: When The Safety Connection Of The Pressure Alarm (Over Pressure/Low Pressure) Is Set To "Pump Coast

    Other Operation Procedures a When the safety connection of the Pressure Alarm (over pressure/low pressure) is set to “Pump Coast” (This example describes when pump coast is activated when the Over Pressure Alarm is issued for P1.)  Setting of the Controller Turn the P1 pressure measuring function on.

  • Page 96: When The Safety Connection Of The Air Bubble Detected Alarm Is Set To "Pump Coast

    Other Operation Procedures b When the safety connection of the Air Bubble Detected Alarm is set to “Pump Coast”  Setup of the Controller Turn the air bubble detector function on. For details about how to set, refer to “Setting the Air Bubble Detector Function”...

  • Page 97: When The Safety Connection Of The Air Bubble Detected Alarm Is Set To "Clamp+Pump Stop

    Other Operation Procedures While monitoring the flow, adjust the motor speed to achieve the necessary flow. The status lamp is lit in green, and the alarm sound stops. “Air Bubble: Pump Coasting” on the message area is turned off. c When the safety connection of the Air Bubble Detected Alarm is set to “Clamp+Pump stop” ...
  • Page 98 • If the lever does not return to the original position, pull down the lever. If it does not return to the original position, a failure may have occurred. Stop using the system immediately, and contact Terumo’s service representative. Lever...

  • Page 99: When The Safety Connection Of The Back Flow Alarm Is Set To "Clamp+Pump Stop

    Other Operation Procedures Keep clamping the blood line with forceps. Turn the motor speed knob to adjust the motor speed to a speed that does not cause back flow. Gradually release the clamp of the blood line. The status lamp is lit in green, and the alarm sound stops. “Air Bubble: Pump Stop”...
  • Page 100 • If the lever does not return to the original position, pull down the lever. If it does not return to the original position, a failure may have occurred. Stop using the system immediately, and contact Terumo’s service representative. Lever Figure 2-10 Keep clamping the blood line with forceps.

  • Page 101: Battery-Powered Operation

    Other Operation Procedures Battery-powered Operation The Controller contains battery. If the AC power supply is lost or not sufficient, the AC power is automatically switched to battery power. The battery will supply power for about an hour. (On the condition that a new battery is charged for more than six hours, and then it is used with 2500 RPM motor speed and 4 LPM (L/min) flow) The battery is recharged by connecting the Controller to the AC power source.
  • Page 102 Other Operation Procedures  Battery charge level display (On LCD touch panel display) Battery status (On control panel) Battery indicator lamp Battery charge level indicator Five segments (green) 100% Three segments (green) Four segments (green) 80 - 99% Three segments (green) 60 - 79% Two segments (green) 40 - 59%...

  • Page 103: Key Lock

    Other Operation Procedures Key Lock Locking the LCD touch panel and control panel prevents inadvertent operation. <<Operation from the main screen>> Tap the key lock icon on the LCD touch panel display. (Figure 2-14) The key lock icon is lit in green, and the key lock turns on. The key lock button on the control panel is lit in orange at the same time.

  • Page 104: Count Up Timer

    Other Operation Procedures Notes • When tapping [Cancel], the key lock is not disabled, and the key lock remains enabled. • When an alarm or alert is issued while key lock is enabled, the key lock is automatically cancelled, and the colour indicators on the key lock icon and key lock button will turn off.

  • Page 105: Count Down Timer

    Other Operation Procedures  Resetting the timer While the timer count is stopped, tap the count up timer indicator. (Figure 2-23) Figure 2-23 Tap [Reset], and tap [OK]. (Figure 2-24) Figure 2-24 The timer count is reset, and the indication returns to “00-00:00:00”. (Figure 2-25) Figure 2-25 Count Down Timer...

  • Page 106: Perfusion Index Calculation

    Other Operation Procedures Perfusion Index Calculation The body surface area (BSA) is calculated using Dubois or Boyd formula when the patient information (height and weight) is input. The perfusion index calculated by the BSA and flow data is displayed on the main screen. For details about how to set height and weight, refer to “Setting BSA”...

  • Page 107: Event List

    Controller on. For details about how to set up the LAN communication function, refer to “Setting LAN” (page 110). Configuration of the Controller and Network Equipment A direct connection between the Controller and network equipment with a LAN cable is recommended. Contact Terumo’s service representative regarding a connection through a switching hub. Note •...

  • Page 108: Setting Of The Controller

    Setting of the Controller The following parameters can be set for the Controller. For details about how to operate the screen, refer to “Setting LAN” (page 110). Contact Terumo’s service representative regarding a connection through a switching hub. Parameter Description MAC address filtering Sets to perform communication with specific MAC addresses only.
  • Page 109 Other Operation Procedures Refer to the table below for an explanation of each item. Item Overview Description Remark Data start Indicates the data start. Year/month/ AD four digits for year, 01 to 12 for month, 01 to 31 for day, day/hour/ 00 to 23: 24-hour clock for hours, 00 to 59 for minutes, minute/second,...

  • Page 110: Specification Of Network Communication (Sequence)

    Other Operation Procedures Specification of Network Communication (Sequence) The Controller connects TCP connection to the port of the designated IP address and transmits data. Network equipment serves as the TCP Server and waits for the connection from the Controller. The flow when the communication connection is started is shown below. Network equipment Controller (Server)

  • Page 111: Cdi Communication

    Other Operation Procedures The flow when the communication is disconnected is shown below. Network equipment Controller (Server) (Client) recv( ) disconnect( ) Unconnected (close) CDI Communication The flow information can be transmitted to the CDI System 500. Before the power is turned on, connect the CDI port of the Controller to the pump interface terminal of the CDI System 500 with the CDI Communication Cable, and turn the setting of the CDI communication function of the Controller on.

  • Page 112: Various Menu Settings

    Various menu settings Two Types of Setup modes This system can set up various menus through two types of system setup. The settings can be changed in accordance with the change of the patient’s status and use conditions. The changes made are returned to the settings of the admin setup when the power is turned off. User setup For details about how to set, refer to “User Setup”...

  • Page 113: Setting Flow Alarms

    Various menu settings Reference Icon name Function Initial setting value page Displays the settings of each menu by The list of admin settings set under the page 92 Alarm Setup List list. each menu of the admin setup. Inputs the Patient’s height and weight Height: ---.- page 93 to calculate the BSA value and...

  • Page 114: Setting Pressure Measuring Function

    Various menu settings Tap [Alarm] of the lower limit. (Figure 3-4) Figure 3-4 to input the lower limit value you want to set. (Figure 3-5) “ (red)” indicates the threshold value of the Low Flow Alarm in accordance with an input flow value. Figure 3-5 Tap [OK] to complete the setting.
  • Page 115 Various menu settings Tap the channel (P1 or P2) you want to set. (Figure 3-8) The following figures show the example when [P1] is selected. Figure 3-8 <<Setting the on/off status of the pressure measuring function>> Tap [On] or [Off]. (Figure 3-9) When turning it off, tap [OK] to complete the setting.
  • Page 116 Various menu settings to input the lower limit value you want to set. (Figure 3-13) “ (red)” indicates the threshold value of the Low Pressure Alarm in accordance with an input pressure value. Proceed to “Setting the threshold value of the Pressure Alert”. Figure 3-13 <<Setting the threshold value of the Pressure Alert>>...

  • Page 117: Setting Temperature Measuring Function

    Various menu settings Tap [OK] to complete the setting. (Figure 3-18) Figure 3-18 Notes • If you do not tap [OK], the changes to the setting will not take effect. • The lower/upper limits of the alarm cannot be input unless the values are higher/lower than those of the alert. When the values cannot be input, check that the values of the lower/upper limits of the alarm are correct in relation to the lower/upper limits of the alert.
  • Page 118 Various menu settings <<Setting the threshold value of the Temperature Alert>> Confirm that [Alert] of the upper limit is selected. (Figure 3-22) Figure 3-22 to input the upper limit value you want to set. (Figure 3-23) “ (yellow)” indicates the threshold value of the High Temperature Alert in accordance with an input temperature.

  • Page 119: Setting The Fast Clamp

    Various menu settings Setting the Fast Clamp The on/off status of the fast clamp function can be set. Tap the Fast clamp icon. (Figure 3-27) The Fast clamp screen opens. Figure 3-27 After tapping [On] or [Off], tap [OK] to complete the setting. (Figure 3-28) Figure 3-28 Note...

  • Page 120: Setting The Safety Connection

    Various menu settings After tapping [On] or [Off], tap [OK] to complete the setting. (Figure 3-30) Figure 3-30 Notes • If you do not tap [OK], the changes to the setting will not take effect. • The air bubble detection sensitivity can be adjusted only through the admin setup. <Indication of the ABD status icon>...

  • Page 121: Alarm Setup List

    Various menu settings Notes • If you do not tap [OK], the changes to the setting will not take effect. • For details about the safety connection, refer to “Safety Connection” (page 65). Alarm Setup List The on/off status of various functions, alarm or alert threshold values and the settings of the safety connections can be confirmed in the list.

  • Page 122: Setting Bsa

    Various menu settings Setting BSA When you input the patientʼs height and weight, you can check the calculated BSA (body surface area) value. Subsequently, the perfusion index is displayed in the perfusion index indicator on the LCD touch panel display. For details about the perfusion index indicator, refer to “LCD Touch Panel Display (When Operating Normally)”...

  • Page 123: Setting Count Down

    Various menu settings Setting Count Down A count down timer can be set. When the set time has passed, you will be informed by sound and screen indication. The maximum duration that can be set is 9 hours, 59 minutes and 59 seconds. Count Down screen Number Icon...

  • Page 124: History

    Various menu settings Tap [Start]. (Figure 3-44) Count down starts. When count down starts, [Start] changes to [Stop]. Note • The count down continues even if another screen is opened. Figure 3-44 When the count down is finished, “Count-down Ended” is displayed on the message area with a sound.
  • Page 125 Various menu settings  Event List Up to 256 alarms and alerts issued after the power was turned on are displayed in the list. Tap [Event List]. (Figure 3-49) Figure 3-49 Up to five events are displayed per page. To scroll, tap When jump to the previous/next page, tap .
  • Page 126 Various menu settings Tap the check box of the log file to export to insert a check mark. (Figure 3-53) Figure 3-53 Tap [Export]. (Figure 3-54) The mounting process of the USB memory drive is performed and the log data export process to the USB memory drive is started. The export status to the USB memory drive is displayed by percentage.
  • Page 127 Various menu settings Notes • Use USB memory drives formatted in the form of FAT or FAT 32. • Do not connect equipment other than USB memory drives to the USB port. • When [Cancel] is tapped while exporting log data, the export cancels. •...

  • Page 128: Admin Setup

    Various menu settings Admin Setup Admin menu settings can be registered in accordance with hospital procedures and protocols. (The admin setting will be maintained even after the power is turned off.) Access to the admin setup is protected by passwords. Opening the Admin Setup Tap the setup icon on the main screen.
  • Page 129 • When the input password is wrong, “Authentication failed.” is displayed. Tap [Return], and restart from step 2 of “Opening the Admin Setup” (page 99). • If you have forgotten your password that you set, ask Terumoʼs service Figure 3-62 representative for initialization of password.

  • Page 130: Admin Setup Screen

    Various menu settings Tap [OK] after confirming the message displayed. (Figure 3-65) The password is changed. Figure 3-65 Admin Setup Screen Tap the icon of the menu you want to set, and then the Admin Setup screen opens. Check the corresponding item for the setup method of each menu. Reference Icon name Function...

  • Page 131: Flow Preset

    Various menu settings Reference Icon name Function Factory setting Remark page Safety Sets the admin setting of Over Pressure P1: Message Only The setting will take page 105 Connection response behaviours when Over Pressure P2: Message Only effect after restarting.* the Pressure Alarm, the Air Low Pressure P1: Message Only Bubble Detected Alarm and...

  • Page 132: Pressure Preset

    Various menu settings Pressure Preset The following admin setup values can be set: • The on/off status of the pressure measuring function • The threshold of the Pressure Alarm and the Pressure Alert (setup range: -250 to 900 mmHg [-33.3 to 120.0kPa]) •...

  • Page 133: Temperature Preset

    Various menu settings Temperature Preset The following admin setup values can be set: • The on/off status of the temperature measuring function • Threshold value of the Pressure Alert (setup range: 0.0 to 50.0°C) For details about how to set, refer to “Setting Temperature Measuring Function” (page 88). Note •...

  • Page 134: Setting The Safety Connection

    Various menu settings Tap [OK] to complete the setting. (Figure 3-71) Figure 3-71 Note • If you do not tap [OK], the changes to the setting will not take effect. Setting the Safety Connection The admin setup of response behaviours (Message Only/Pump Coast/Clamp+Pump stop) for the Pressure Alarm, the Air Bubble Detected Alarm and the Back Flow Alarm can be set up.

  • Page 135: Setting Auto-Priming

    Various menu settings Setting Auto-priming The following values can be set: • On time and off time (setup range: 0.5 to 10.0 s) • Motor speed (setup range: 1000 to 3000 RPM)  Setting Time Tap the Auto-Priming icon. (Figure 3-74) The Auto-Priming screen opens.
  • Page 136 Various menu settings  Setting the motor speed Tap the Auto-Priming icon. (Figure 3-78) The Auto-Priming screen opens. Figure 3-78 Tap [Motor Speed]. (Figure 3-79) Figure 3-79 to input the motor speed you want to set. (Figure 3-80) Figure 3-80 Tap [OK] to complete the setting.

  • Page 137: Setting The Coast Speed

    Various menu settings Setting the Coast Speed The coast speed (the minimum motor speed which does not cause back flow, setup range: 500 to 2000 RPM) can be set. Tap the Coast Speed icon. (Figure 3-82) The Coast Speed screen opens. Figure 3-82 to input coast speed you want to set.

  • Page 138: Setting The Date And Time

    Various menu settings Setting the Date and Time The date and time can be set. Tap the Date & Time icon. (Figure 3-85) The Date & Time screen opens. Figure 3-85 Tap the item you want to set. (Figure 3-86) The following screen examples show when [Year] is selected.

  • Page 139: Setting Lan

    Various menu settings Setting LAN The following values can be set: • LAN connection environment • The on/off status of LAN communication  Setting the IP address of the PC/server Tap the LAN icon. (Figure 3-89) The LAN screen opens. Figure 3-89 Tap [IP] of [PC/Server].
  • Page 140 Various menu settings Input the values into all of the boxes with the same operation as in steps 3 and 4. (Figure 3-93) Figure 3-93 Tap [OK] to complete the setting. (Figure 3-94) Proceed to “Setting the MAC Address”. Figure 3-94 Note •...
  • Page 141 Various menu settings to input the MAC address of the destination PC/server you want to set. (Figure 3-97) The input range is 00 to FF. Figure 3-97 Input the values into all of the boxes with the same operation as in steps 2 and 3. (Figure 3-98) Figure 3-98 Tap [OK] to complete the setting.
  • Page 142 Various menu settings to input the communication port of the destination PC/server you want to set. (Figure 3-101) The input range is 0 to 65535. Figure 3-101 Tap [OK] to complete the setting. (Figure 3-102) Proceed to “Setting the DHCP”. Figure 3-102 ...
  • Page 143 Various menu settings  Setting the IP address of the Controller Tap [IP] of [Controller]. (Figure 3-106) The IP (Controller) screen opens. Figure 3-106 Tap the button of the address value you want to input. (Figure 3-107) The following screen examples show when the top button is selected. Figure 3-107 to input the IP address of the Controller you want to set.
  • Page 144 Various menu settings  Setting the Subnet Mask Tap [Subnet Mask] of [Controller]. (Figure 3-111) The Subnet Mask screen opens. Figure 3-111 Tap the button of the address value you want to input. (Figure 3-112) The following screen examples show when the top button is selected. Figure 3-112 to input the subnet mask of the Controller you want to set.

  • Page 145: Setting The Communication With Cdi

    Various menu settings  Setting the On/Off status of the LAN communication Tap [On/Off] of [Controller]. (Figure 3-116) The On/Off screen opens. Figure 3-116 Select [On] or [Off]. (Figure 3-117) When [Off] is selected, the setting values thus far are maintained, but communication is not performed.
  • Page 146 Various menu settings Select [On] or [Off] of the CDI screen. (Figure 3-120) Figure 3-120 Tap [OK] to complete the setting. (Figure 3-121) Figure 3-121 Note • If you do not tap [OK], the changes to the setting will not take effect.

  • Page 147: Setting The Language

    Various menu settings Setting the Language The language to be displayed (English/ ) can be set. Note • The changes to the setting will take effect after restarting. Tap the Language icon. (Figure 3-122) The Language screen opens. Figure 3-122 Select the language to be displayed.
  • Page 148 Various menu settings Select the volume level. (Figure 3-126) Tap [Large], [Middle], or [Small]. Figure 3-126 Select the brightness level. (Figure 3-127) Tap [Light], [Moderate], or [Dark]. Figure 3-127 Tap [OK] to complete the setting. (Figure 3-128) Figure 3-128 Notes •...

  • Page 149: After Use

    After Use In order to ensure the safe use of this system, make sure it is cleaned after use and stored in an appropriate environment. If the system is used while it is dirty, the system may not operate properly or may cause a malfunction. Cleaning Cautions •...

  • Page 150: Cleaning Method

    Benzalkonium chloride When using a disinfectant solution, refer to instructions for use (Regarding dilute concentration, etc.) of each disinfectant solution. If you have any questions, contact Terumoʼs service representative. Cleaning Method Clean immediately with a damp (not wet) soft cloth.

  • Page 151: Maintenance And Inspections

    Maintenance and Inspections To ensure safe operation and the longest possible life, perform periodic maintenance and inspections. If any fault is detected, immediately stop using the system and contact Terumo’s service representative. Cautions • Since this system is precision equipment, it should not be used if it has received any impact (drop to floor, falling, violent shock).
  • Page 152 Maintenance and Inspections  Inspection method of start-up sequence (Before each use) Connect the AC power cable to the Controller. Status lamp Plug in the AC power cable to the grounded AC power source. Connect the Drive Motor and the ABD/Flow Sensor. Auto priming button Turn on the power.
  • Page 153 Maintenance and Inspections Plug in the AC power cable. Checks • The On Battery Alarm stops. • The AC power lamp is lit. • The AC power indicator changes to Change the motor speed to 0 RPM to stop the Drive Motor. Turn off the power.

  • Page 154: Inspection Before Circulation Starts (Before Each Use)

    Maintenance and Inspections Inspection Before Circulation Starts (Before Each Use) After priming, perform the inspections in the following sequence before circulation starts: • Inspection of the motor drive • Inspection of the ABD/Flow Sensor • Inspection of the Fast Clamp ...
  • Page 155 Maintenance and Inspections  Inspection method of the Fast Clamp (Before each use) When using the Fast Clamp, follow the procedures below to perform the inspection: Attach the tube of the blood line to the Fast Clamp. Tap the setup icon. (Figure 5-8) Figure 5-8 Tap the Fast clamp icon on the Setup screen.

  • Page 156: Six-Month Inspection

    • If the lever does not return to the original position, pull down the lever. If it does not return to the original position, a failure may have occurred. Stop using the system immediately, and contact Terumo’s service representative. Fast Clamp...
  • Page 157 • Do not disassemble, make alterations (including actions that interfere with the functionality or performance such as taping the LCD or a movable part) to, or repair this system. This may result in failure, damage or device performance degradation of this system. Note • Since the battery is built-in, contact Terumo’s service representative when replacing it.

  • Page 158: Sp-200 Maintenance/Inspection Check List

    Maintenance and Inspections SP-200 Maintenance/Inspection Check List Serial number: Date: Person in charge: Check items Inspection before each use Inspection of the • Are there any significant scratches or damage in the appearance? Pass Fail external appearance • Are there any scratches or pinch marks on the outer covering of the cables? Pass Fail (Before each use)
  • Page 159 Pass Fail Overall judgement (If any one item is judged as fail, repairs are necessary. Immediately stop using the system and contact Terumo’s service representative.) Remarks: Serial number: Date: Person in charge:...

  • Page 160: Maintenance And Inspection Items By Terumo's Service Representative

    Cable, the CDI Communication Cable after designated inspection is implemented is two years (by self-certification). The service life of the equipment is at least 6 years in the case of standard use. If service life is exceeded, be sure to ask Terumo for a comprehensive inspection and repair including parts replacement.

  • Page 161: Alarms And Troubleshooting

    When an alarm/error occurs, the factors below may be the cause. Follow the procedure for dealing with each alarm/error as it arises. If the abnormality persists, the system may have failed. Stop using the system immediately and contact Terumo’s service representative.
  • Page 162 • Enable the USB memory drive writable, and try to export the data again. The password to open admin • Contact Terumo’s service representative to setup is lost. initialize the password.

  • Page 163: List Of Alarm Messages

    Backup prevent circulation from Controller or to the Hand Crank. being maintained. After taking the above precautions, contact Terumo’s service representative. Battery Empty Detected that battery is Maintain circulation by immediately High E908 depleted.
  • Page 164 Alarms and Troubleshooting Message display Cause/Occurrence Action Priority Error code Low Flow Alarm* Detected that flow has fallen a Check that there is no abnormality in High below the setup flow alarm the blood circuit. threshold. b Adjust the motor speed to render appropriate flow.
  • Page 165 The system may have failed. Do not Medium abnormality requiring disconnect the AC power source. In inspection after use. addition, contact Terumo’s service representative as soon as the current case ends. Battery-powered Detected that battery- If this alarm is issued unintentionally, check...
  • Page 166 Clamp Error* Detected failure of the Fast The Fast Clamp may have failed. Clamp. Stop using the Fast Clamp and contact Terumo’s service representative. LAN Connection Detected an abnormality a Check that a proper cable is being used Error* of the LAN communication to connect with the external device.

  • Page 167: Specifications

    Specifications System Specifications (Controller) CAPIOX Centrifugal Pump Controller SP-200 Product name ME * SP200C (Identification code: SP200C * ): Controller Catalogue number ME * SP200C2 (Identification code: SP200C2 * ): Controller ME * SP200C3 (Identification code: SP200C3 * ): Controller ME * SP200M: Drive Motor ME * SPFAS01: ABD/Flow Sensor (for standard tube circuit) ME * SPFAS02: ABD/Flow Sensor (for soft tube circuit)
  • Page 168 Specifications Air Bubble Detected Alarm, Flow Alarm, Back Flow Alarm, Pressure Alarms and safety functions Alarm (High priority), Pressure Alarm (Low priority), Temperature Alarm, Low Battery Alarm, Battery Empty Alarm, Battery-powered operation started Alarm, On Battery Alarm, Serious System Error Alarm (High priority), System Error Alarm (Medium priority), CDI Connection Error / LAN Connection Error Alarm, Drive Motor Disconnected Alarm, ABD/Flow Sensor Disconnected Alarm, Flow Signal Unstable...

  • Page 169: Accessories

    * Excluding width and depth of caster 35 kg Unit weight • CAPIOX centrifugal pump Related components • CAPIOX EBS Circuit with X coating • CAPIOX Luer Thermistor • CDI System 500 • Pressure sensor (Compliant with ANSI/AAMI BP22:1994) * Limited to items that can be connected to connectors.

  • Page 170: For Medical Staff

    For Medical Staff This product is a system that conforms to the EMC (electromagnetic compatibility) standard, IEC 60601-1-2:2007 required for the safe use of medical electrical equipment. EMC (Electromagnetic Compatibility) EMC (electromagnetic compatibility) refers to the ability to satisfy the following two items: •...
  • Page 171 For Medical Staff Table 2 – Guidance and MANUFACTURER’S declaration – electromagnetic IMMUNITY – for all ME EQUIPMENT and ME SYSTEMS (see 5.2.2.1 f) Guidance and manufacturer’s declaration – electromagnetic immunity The CAPIOX Centrifugal Pump Controller SP-200 is intended for use in the electromagnetic environment specified below. The customer or the user of the CAPIOX Centrifugal Pump Controller SP-200 should assure that it is used in such an environment.
  • Page 172 For Medical Staff Table 3 – Guidance and MANUFACTURER’S declaration – electromagnetic IMMUNITY – for LIFE-SUPPORTING ME EQUIPMENT and ME SYSTEMS (see 5.2.2.2) Guidance and manufacturer’s declaration – electromagnetic immunity The CAPIOX Centrifugal Pump Controller SP-200 is intended for use in the electromagnetic environment specified below. The customer or the user of the CAPIOX Centrifugal Pump Controller SP-200 should assure that it is used in such an environment.
  • Page 173 For Medical Staff Table 5 – Recommended separation distances between portable and mobile RF communications equipment and the ME EQUIPMENT or ME SYSTEMS – for LIFE-SUPPORTING ME EQUIPMENT and ME SYSTEMS (see 5.2.2.2) Recommended separation distances between portable and mobile RF communications equipment and the CAPIOX Centrifugal Pump Controller SP-200 The CAPIOX Centrifugal Pump Controller SP-200 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.

  • Page 174: Symbol

    Symbol This section describes the symbols used with the CAPIOX Centrifugal Pump Controller SP-200. Symbol Description of Symbols Symbol Description of Symbols Catalogue number Direct current Serial number Consult instructions for use Batch code Contents Manufacturer Temperature limitation IP42 IEC 60529 Degrees of protection Relative humidity limitation provided by enclosures (IP code) IP54...

  • Page 175: Memo

    Memo...
  • Page 176 Memo...

  • Page 177: For Information About Terumo Products

    Tel.: +66 2 260 7020 Fax: +66 2 260 7019 As of February, 2016 ME_SP200C_E_500_001 TERUMO CORPORATION 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO 151-0072, JAPAN , EBS, and X coating are trademarks of TERUMO CORPORATION. ® : Registered trademark ©TERUMO CORPORATION 2016-02 16B19...

Table of Contents

Save PDF