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Haemonetics ACP 215 Operation Manual

Automated cell processing system
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Haemonetics
ACP™215
Automated Cell Processing System
– Operation Manual –
0123
Printed in France
Haemonetics Corporation
400 Wood Road, Braintree, MA 02184, USA
P/N 85271-30, Manual revision: C
©2003, Haemonetics International. All rights reserved.
January 2003

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Summary of Contents for Haemonetics ACP 215

  • Page 1 ® Haemonetics ACP™215 Automated Cell Processing System – Operation Manual – 0123 Printed in France Haemonetics Corporation 400 Wood Road, Braintree, MA 02184, USA P/N 85271-30, Manual revision: C ©2003, Haemonetics International. All rights reserved. January 2003...
  • Page 3 Any modifications estimated as neces- sary by the customer should be evaluated by a Haemonetics Clinical Specialist. Safe utilization of Haemonetics material and equipment requires the operator to correctly handle and dispose of blood-contaminated material.
  • Page 4 Elmete Lane, Roundhay Tel. [+86 21] 5066 3366 Leeds LS8 2LQ, United Kingdom Fax [+86 21] 6841 3688 Tel. [+44 113] 273 7711 Haemonetics CZ, spol. s r.o. Fax [+44 113] 273 4055 Ptašínského C.8 Haemonetics SA 60200 Brno, Czech Republic Signy Centre, rue des Fléchères...
  • Page 5 What is the ACP 215 system ? ....... . 1-2...
  • Page 6 Procedure HANDLING THE ACP 215 EQUIPMENT ......4-2 Storing the device and material ....... 4-2 Inspecting the material .
  • Page 7 What is the ACP 215 system ? ....... . .
  • Page 8 What is the This manual is intended to supply anyone involved in using the ACP 215 equip- purpose of this ment with information to attain:...
  • Page 9 Text preceded by this bullet indicates an item on a list of information for the operator. Symbols found on The following symbols are found on the ACP 215 device. the device Type B Protection against electric shock, particularly regarding: allow- able leakage current and reliability of the protective earth connection.
  • Page 10 (under applicable conditions). Attention (Consult accompanying documents) Symbols found on The following symbols are used by Haemonetics on disposable set packaging. disposable pack- aging Catalog number...
  • Page 11 Explaining General Information Fluid path sterile by exposure to gamma irradiation STERILE R Do not reuse Caution: consult operator manual for instructions KEEP DRY [storage conditions] Storage conditions, temperature level yy˚C -yy˚C P/N 85271-30, Manual revision: C...
  • Page 12 Explaining General Information ACP 215 ISTING DEVICE SPECIFICATIONS Dimensions and The approximate weight and dimensions of the ACP 215 device are as follows: weight Value (approximate) Characteristic Cabinet cover open Cabinet cover closed Height 67.5 cm [26.5 inches] 43 cm [17 inches] Width 55 cm [21.5 inches]...
  • Page 13 EMC require- ments. Therefore, non-approved accessories and cables must not be used. In addition, the ACP 215 device and accessories must not be placed directly adja- cent to, or top of other equipment, unless specifically approved by Haemonetics.
  • Page 15 Presenting the ACP 215 Equipment DESCRIBING THE ACP 215 CONTROL PANEL ..... . 2-3 Display screen ..........2-3 Keypad .
  • Page 16 Presenting the ACP 215 Equipment Figure 2-1, The ACP 215 device with the shaker P/N 85271-30, Manual revision: C...
  • Page 17 ESCRIBING THE CONTROL PANEL The control panel is located on the inside of the ACP 215 cabinet cover. It consists of a display screen and a keypad, containing groups of keys used to operate the device. There is a protective plastic coating on the keypad, which allows for effi- cient cleaning and disinfecting.
  • Page 18 The detector is mounted on the wall of the centrifuge well. The ACP 215 safety system will automatically stop the centri- fuge and the pumps if there is contact between liquid of any sort and the fluid detector.
  • Page 19 Presenting the ACP 215 Equipment Pumps Located on the left side of the ACP 215 top deck are two pumps which use peri- staltic movements to displace fluids through the disposable set tubing. Figure 2-4, ACP 215 pump rotor Blood Pump The blood pump will rotate during certain procedures simultaneously with the solution pump to direct solution to the RBC bag.
  • Page 20 Figure 2-5, Example of an air detector Optical line Located on the right side of the ACP 215 top deck is the optical line sensor which sensor monitors the blood components passing through the effluent tubing. Caution: The line sensor will not provide accurate readings if the optical lens it is obstructed in any way;...
  • Page 21 Figure 2-6, Power entry module (PEM) Power cord The power cord provided by Haemonetics is designed to connect the ACP 215 device with an external power source via the power-input receptacle, located on the power entry module on the side panel.
  • Page 22 Shaker During certain procedures, a shaker device manufactured by Haemonetics prop- erly mixes the blood in the RBC bag with the added solutions. The ACP 215 device provides power to the shaker and controls the shaker operation. The RBC bag is secured on the shaker platform with magnets.
  • Page 23 Examples of a printout are provided in each procedure operation manual. The ACP 215 device controls the printer, however the printer has an independent power source via a wall unit adapter that converts AC into DC.
  • Page 24 2-10 Presenting the ACP 215 Equipment To remove the printer AC adaptor, the operator should: Power off the printer first. " Unplug the AC adaptor and the DC plug. " The operator should not touch the pins of the DC plugs.
  • Page 25 Chapter 3 Maintaining the ACP 215 Equipment CLEANING PROCEDURES........3-2 Listing tools and cleaning supplies .
  • Page 26 Annual preventive mainte- nance should be performed by a Haemonetics service representative. The frequency and type of cleaning each ACP 215 device will depend on the number of procedures performed. Special cleaning needs may arise and should be dealt with promptly.
  • Page 27 Maintaining the ACP 215 Equipment Exterior surfaces, The exterior cabinet, keypad, display screen, valves, shaker and printer should valves, shaker be wiped daily, as well as following any spill, using an appropriate cleaning solu- tion. and printer Pressure The pressure monitors (DPM/SPM) should be cleaned in the following manner.
  • Page 28 " Lubricate the O-ring gasket with a small amount of the silicon lubricant. Haemonetics recommends that the operator wear protective gloves to avoid direct contact with the cleaning solution and/or any spilled blood which may be present.
  • Page 29 Filter screens The ACP 215 device is equipped with filter screens on the bottom of the cabinet, which eliminate dust from incoming cool air. The filters should be cleaned routinely, especially if dust becomes visible on the screens.
  • Page 30 Haemonetics employs a staff of Clinical Specialists to provide training in the use of the ACP 215 equipment. The local Haemonetics representative will schedule staff training upon delivery of the ACP 215 equipment and should be contacted to organize further instruction when needed.
  • Page 31 Maintaining the ACP 215 Equipment In some cases, it may be necessary to dispose of the contaminated goods after reporting the problem to the Haemonetics representative. This should be done according to the locally established guidelines pertaining to the disposal of biologically contaminated material.
  • Page 33 ACP 215 Procedure HANDLING THE ACP 215 EQUIPMENT ......4-2 Storing the device and material....... . 4-2 Inspecting the material .
  • Page 34 Storing the The ACP 215 device must not be operated or stored in an area where flammable device and gases or vapors are present. The ACP 215 disposable set material should be kept in a dry, well-ventilated area and isolated from any chemical vapors.
  • Page 35 If there is any suspicion that hemolysis has occurred, the operator should follow the local SOP applicable in this type of situation. The operator should also contact the local Haemonetics representative if there is any suspicion of a mechanically induced problem.
  • Page 36 Overheating can occur, subsequently lead to hemolysis and make any blood being processed unsafe for reinfusion. During operation the operator should interrupt the ACP 215 procedure if an abnormality or noise appears, related to the spinning bowl.
  • Page 37 Ensuring Safety and Quality for an ACP 215 Procedure ARNINGS FOR THE OPERATOR Electrical shock The operator should always use the ACP 215 device with clean, dry hands, or hazards gloves. The internal parts of the device contain various electrical components.
  • Page 38 Maintaining the ACP 215 Equipment. Proper disposal of biologically contaminated materials Any disposable material used during an ACP 215 procedure is considered as biologically contaminated. It must be disposed of according to local standard operating procedure for the removal of such material and should not be mixed with non-biologically contaminated waste.
  • Page 39 Chapter 5 Troubleshooting for the ACP 215 Device LISTING SYSTEM ERROR MESSAGES ......5-2 LISTING INTERRUPT SAFETY SYSTEM MESSAGES .
  • Page 40 Troubleshooting for the ACP 215 Device ISTING SYSTEM ERROR MESSAGES When the ACP 215 device is powered-on, several internal tests are performed. Any test failure will interrupt the test sequence and a system error message will be displayed. If a message of this type is displayed, the operator should record the message, power off the device and contact Haemonetics Field Service.
  • Page 41 Troubleshooting for the ACP 215 Device System Error Message Corrective Action SPM FAILED 80% ANALOG TEST 1. Power off the ACP 215 device. 2. Contact Haemonetics Field Service. CODE = 11 Please POWER OFF XXX* VALVE POSITION FAULT 1. Power off the ACP 215 device.
  • Page 42 Troubleshooting for the ACP 215 Device System Error Message Corrective Action AIR DETECTOR FAULT: [BLAD] 1. Power off the ACP 215 device. 2. Contact Haemonetics Field Service. CODE = 510 Please POWER OFF DPM OUT OF TOLERANCE 1. Power off the ACP 215 device.
  • Page 43 Troubleshooting for the ACP 215 Device ISTING INTERRUPT SAFETY SYSTEM MESSAGES Specific inputs are checked at 50 ms intervals during an ACP 215 procedure. If an error is detected, all peripherals are shut down, and an error message is displayed.
  • Page 44 If there is a spill in the centrifuge, the centrifuge and pump(s) Please POWER OFF will stop. 1. Power off the ACP 215 device. 2. Refer to the appropriate section of the manual for guidance on handling a blood spill.
  • Page 45 Troubleshooting for the ACP 215 Device Interrupt Safety System Message Corrective Action ============================= 1. Power off the ACP 215 device. 2. Contact Haemonetics Field Service. INTERNAL SOFTWARE ERROR MODULE: XXX* LINE: XXX STATE: XXX PARAM: XXX ============================= * XXX DENOTES THE VALUE DISPLAYED INTERNAL SOFTWARE ERROR 1.