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P/N 85266-30, Manual revision: A

Chapter 4

Ensuring Safety and Quality
for a PCS2 Procedure

HANDLING THE PCS2 EQUIPMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

Storing the PCS2 device and material . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Inspecting the material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

PREVENTING PROBLEMS DURING A PCS2 PROCEDURE . . . . . . . . . . . . . 4-3

Understanding the risk of hemolysis . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Avoiding the consequences of flow restriction  . . . . . . . . . . . . . . . . . . . 4-3
Avoiding bowl misalignment  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Avoiding overheating due to mechanical situations  . . . . . . . . . . . . . . . 4-4
Controlling for Red Cell Overrun . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4

WARNINGS FOR THE OPERATOR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5

Electrical shock hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Leakage current control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Mechanical hazards/rotating parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Power outlet connection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Communicable disease precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6

Содержание PCS 2

Страница 1: ...ed in France Haemonetics Corporation 400 Wood Road Braintree MA 02184 USA P N 85266 30 Manual revision A 2002 Haemonetics International All rights reserved April 2002 Working with the Haemonetics PCS...

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Страница 3: ...g from failure to comply with prescriptions as outlined by the company Any modi fications estimated as necessary by the customer should be evaluated by a Haemonetics Clinical Specialist Safe utilizati...

Страница 4: ...Cheng East Road Shangai 200120 PRC Tel 86 21 506 63366 Fax 86 21 684 13688 Haemonetics CZ spol S r o Pta nsk ho C 8 60200 Brno Czech Republic Tel 42 05 412 122400 Fax 42 05 412 122399 Haemonetics Fran...

Страница 5: ...onetics UK Ltd Beechwood House Beechwood Estate Elmete Lane Roundhay Leeds LS8 2LQ United Kingdom Tel 44 113 273 7711 Fax 44 113 273 4055 Haemonetics S A Signy Centre P O Box 262 CH 1274 Signy 2 Switz...

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Страница 7: ...s found on the device 1 5 Symbols found on disposable packaging 1 8 LISTING DEVICE SPECIFICATIONS 1 9 Chapter 2 Describing the PCS2 Device Components PRESENTING THE PCS2 DEVICE COMPONENTS 2 3 DESCRIBI...

Страница 8: ...ining 3 6 Field service 3 6 Returned Goods Authorization system 3 6 HAEMONETICS CLEANING AND MAINTENANCE RECORD 3 8 Chapter 4 Ensuring Safety and Quality for a PCS2 Procedure HANDLING THE PCS2 EQUIPME...

Страница 9: ...s the Haemonetics Plasma Collection System 2 1 3 What are the characteristics and features of the PCS2 1 3 What are the special features of the PCS2 1 4 What is required to perform a procedure 1 4 UND...

Страница 10: ...tion of specific components z The subsequent return of the non selected components to the donor or patient What is the purpose of this manual This manual is intended to supply anyone involved in using...

Страница 11: ...ator has initiated a PCS2 procedure plasma collection will proceed automatically The appropriate amount of anticoagulant solution will be mixed in the disposable tubing with whole blood from the donor...

Страница 12: ...ox or internal data card z Barcode reader What is required to perform a procedure PCS2 collection procedures are quick and simple to perform The following material is required to perform a PCS2 proced...

Страница 13: ...jury to either the donor or the operator Symbolsfoundon the device The descriptions of the following symbols are based on information provided in the following documents z IEC Standard 60601 1 Medical...

Страница 14: ...itch indicating disconnection from the mains Power ON Position of the main power switch indicating connection to the mains IPX1 Protection against ingress of liquid Indicates that the enclosure of the...

Страница 15: ...ion 1 7 P N 85266 30 Manual revision A The following symbols have been designed for devices manufactured by Haemonetics Bar code reader connection RS232 connection RS232 connection with power to one p...

Страница 16: ...CATALOG NUMBER EXPIRATION DATE Lot Number Sterilized by exposure to Ethylene Oxide Fluid path STERILE by exposure to Ethylene Oxide Sterilized by exposure to Gamma irradiation Fluid path STERILE by e...

Страница 17: ...ce used must be properly grounded Characteristics Values Cabinet cover open Cabinet cover closed Height 63 cm 44 cm Width 55 cm Depth 55 cm 32 cm Depth with communication box 55 cm 37 cm Weight 26 4 k...

Страница 18: ...d by Haemonetics and porta ble communication equipment can affect the PCS2 device Any accessories and cables not approved by Haemonetics used in conjunction with the device may increase hazards and in...

Страница 19: ...7 Weigher 2 7 Pumps 2 8 Valves 2 9 Donor flow lights 2 10 Air detectors 2 11 Pressure monitors 2 13 Blood filter holder 2 14 Solution bag poles 2 2 14 Power entry module 2 15 Power cord 2 15 Pressure...

Страница 20: ...7 Plasma valve yellow 8 Saline valve white 9 Donor flow lights x2 10 Anticoagulant line air de tector ACAD 11 Blood line air detector BLAD 12 Donor line air detector 1 DLAD1 13 Donor line air detecto...

Страница 21: ...the tubing which is either z Transporting blood away from the donor before entering the bowl z Transporting blood from the bowl before return to the donor Effluent tubing refers to the tubing exiting...

Страница 22: ...nge of 3000 to 8000 revo lutions per minute This centrifugal force will separate anticoagulated whole blood into its various components The PCS2 centrifuge system consists of z A system sealing mechan...

Страница 23: ...ed to meet the rim the tabs must be firmly pressed together in order to completely close the lid and provide a seal around the stationary head of the disposable bowl The split halves of the lid are ma...

Страница 24: ...ure 2 5 PCS2 centrifuge well components Centrifuge base The centrifuge base contains a centrifuge chuck designed to hold the disposable bowl in place during operation When installing a bowl the operat...

Страница 25: ...ure z The weigher arm must be fully extended positioned at a 90 degree an gle to the PCS2 top deck prior to the system self tests z The plasma collection container must hang freely without any contact...

Страница 26: ...turn simultaneously to thread the tubing onto the pump rotors z During the PRIME mode the AC pump and the Blood pump turn simul taneously to provide the inlet side of the donor line tubing with AC so...

Страница 27: ...he donor into the centrifuge bowl z During the RETURN mode it remains open so that components remain ing in the disposable tubing and centrifuge bowl can be returned to the donor Plasma valve yellow T...

Страница 28: ...l from the donor If the RED flow light is lit the Blood pump will automatically stop The centrifuge will continue to spin to ensure continued separation of the collected blood components When donor bl...

Страница 29: ...nction once the AC solution has passed through the AC pump tubing Blood Line Air Detector BLAD This air detector located on the top deck of the PCS2 cabinet to the right of the blood pump will serve a...

Страница 30: ...nts being returned to the donor The DLAD mon itor the line for any air which may have passed into the system undetec ted probability very low by the BLAD Warning In the case of any air detection alarm...

Страница 31: ...o measure the pressure in the donor line This connection should not be disrupted at any point In the event of a power failure the operator should refer to the chapter Troubleshooting During a PCS2 Pro...

Страница 32: ...trifuge bowl remains intact If the SPM detects that pressure in the system increases or decreases abnormally the PCS2 safety system will stop the pumps and provide an explanatory message with an alarm...

Страница 33: ...de panel Pressure cuff The tourniquet style pressure cuff is used to maintain an optimal venous blood flow from the donor during specific phases of the collection procedure The cuff should be attached...

Страница 34: ...according to standards re quired by EN 60601 1 2 EMC of medical electrical equipment The measured error rate of data communicated to HaemoNet at certain specific electromagnetic frequencies rises abov...

Страница 35: ...play screen will provide data related to procedure status as well as donor status throughout the entire procedure The information will be displayed in specific areas as follows Figure 2 13 Example of...

Страница 36: ...M bar graph when visible is located on the right side of the screen The contrast between filled and non filled area in the column will vary to depict the fluctuations in the DPM readings Table 2 1 PCS...

Страница 37: ...ubing into the donor line tubing DRAW key This key is used to initiate the DRAW mode The DRAW mode will move anti coagulated whole blood from the donor through the donor line tubing into the centrifug...

Страница 38: ...ey can be used to either stop the pumps or re start the pumps if stopped by the operator Caution If the pumps have been stopped using this key and remain stopped for longer than two to three minutes d...

Страница 39: ...d after a modification the selected value will become the new system default value until any further modification is made during subsequent PCS2 collection procedures Cuff key This key is located on t...

Страница 40: ......

Страница 41: ...and valves 3 2 Pressure monitors 3 3 Air detectors 3 3 Optical sensors 3 3 Fluid detector 3 4 Centrifuge components 3 4 Pumps 3 5 Filter screens 3 5 Barcode reader 3 5 CUSTOMER SERVICE 3 6 Clinical t...

Страница 42: ...ctors the optical sensors line sensor and op tical bowl sensor the fluid detector and the inside of the centrifuge well z Monthly Clean the pump rotors and the pump wells z Quarterly Clean the filter...

Страница 43: ...inside of the tubing grove The groove should be kept free of any particles such as powder residue from disposable gloves since this could lead to an erroneous detection of air Caution Alcohol may caus...

Страница 44: ...solution and a lint free cloth until all traces of blood components are removed Lubricate the O ring gasket with a small amount of the silicon lubricant Haemonetics recommends that the operator wear p...

Страница 45: ...pump head should not be immersed in water Filter screens The PCS2 device is equipped with filter screens on the bottom of the cabinet which eliminate dust from incoming cool air The filters should be...

Страница 46: ...d standards of quality in design and manufacturing If for any reason merchandise must be returned to the company the customer should refer to the Haemonetics Returned Goods Authorization RGA system pr...

Страница 47: ...ould be done according to the locally established guidelines pertaining to the disposal of biologically contaminated material Warning Haemonetics products must be properly cleaned and packed prior to...

Страница 48: ...fied engineer Annual maintenance performed by Date performed Reviewed by Date initials Action Clean cabinet control panel and valves Clean air detectors Clean pump rotors Clean centrifuge cover and we...

Страница 49: ...PCS2 PROCEDURE 4 3 Understanding the risk of hemolysis 4 3 Avoiding the consequences of flow restriction 4 3 Avoiding bowl misalignment 4 4 Avoiding overheating due to mechanical situations 4 4 Contro...

Страница 50: ...ventilated area and isolated from any chemical vapors The operator should handle the disposable set elements with clean dry hands or gloves The ranges for storing the material should be within 8 to 8...

Страница 51: ...tion If there is any suspicion that hemolysis has occurred the operator should not return the contents of the bowl to the donor The local Haemonetics representa tive should be informed of the problem...

Страница 52: ...s a defective bearing or seal within the centrifuge well In this case the operator should contact the local Haemonetics representative and discontinue use of the PCS2 device until it is serviced Warni...

Страница 53: ...e apheresis center to ensure that this control is performed In the event of any major spill in which fluid may enter the cabinet or an impor tant voltage surge the operator is responsible to ensure th...

Страница 54: ...or blood spill should occur it should be cleaned immediately The oper ator should follow the local standard operating procedure outlining the steps to follow and product s to be used for the disinfect...

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