Technical Training Presentation
73 Pages
Preview
Page 1
Welcome to the Technical training Barkey Prismacomfort
Introduction
Armin Nowack
CEO since 1993 with Barkey
Content of the Technical training •
General conditions for medical devices
•
Barkey Prismacomfort ➢
Components and functional description
➢
Installation and Operation (overview)
➢
Service work
➢
Service menu
➢
Technical Safety Inspection (TSI)
General conditions Components Installation Service work
General conditions for medical devices
Service menu TSI
➢ Medical Device Directive (MDD) 93/42 EWG General requirements for medical devices ➢ DIN EN ISO 60601-1 and following series Standards for medical devices
➢ Certification of the Quality Management System according to ISO 13485; i.e. traceability of devices and spare parts! ➢ Regulation for users of medical products (Germany) Responsibilities of the hospital and the user ➢ Regulations about electrical safety Periodical inspection of the electrical safety ➢ National specific regulations for medical devices i.e. FDA approval
General conditions Components Installation Service work
General conditions for medical devices
Service menu TSI
The MDD defines: The manufacturer of a medical device must guarantee correct functions inside the given tolerances during the whole life cycle of the device. Otherwise the manufacturer must prescribe a Technical Safety Inspection (TSI) in reasonable intervals.
Problem: Electronic components change their characteristics during their life cycle. Conclusion: TSI is necessary for every electronic medical device !
General conditions Components Installation Service work
General conditions for medical devices
Service menu TSI
Barkey defines: To ensure the reliability of the Barkey devices and to ensure the safety for the user and the patient, the TSI is necessary for every electronic medical device! Only qualified personnel may carry out the TSI or service work on Barkey devices. The personnel must read the service manual and the instruction manual thoroughly through before carrying out a TSI or service work.
General conditions Components Installation Service work
General conditions for medical devices
Service menu TSI
Prerequisites for the TSI ➢ The TSI may only be carried out by qualified medical technicians. They must be familiar with the operation of the device. ➢ The operating instructions should be available for consultation. ➢ The tests must be carried out at a room temperature of 20°C to 28°C. Otherwise the values must be calculated to an room temperature of 22°C ➢ All resulting values must be documented in the inspection log. ➢ If the permissible tolerances are exceeded, the device must be re-calibrated or repaired if necessary.
General conditions Components Installation Service work
Content of the Technical training
Service menu TSI
•
General conditions for medical devices
•
Barkey Prismacomfort ➢
Components and functional description
➢
Installation and Operation (overview)
➢
Service work
➢
Service menu
➢
Technical Safety Inspection (TSI)
General conditions Components Installation Service work
Components
Service menu TSI
special holder
Barkey autocontrol 3XPT
Barkey autoline XPT 4R
General conditions Components Installation Service work Service menu
Components Barkey autocontrol 3XPT
TSI
Operating panel Display four buttons two lamps
Sleeve warmer connections two heating devices can be connected
The Barkey autocontrol 3XPT is capable of controlling up to two warming devices.
General conditions Components Installation Service work Service menu
Components Barkey autocontrol 3XPT
TSI
Carrying handle Holder
Type label Ventilation grid
General conditions Components Installation Service work Service menu
Components Barkey autoline XPT 4R
TSI
Sleeve warmer
Connector with electronic
The Barkey autoline XPT 4R is used to heat the inserted blood return line from the Prismaflex device.
The warming sleeve is available for two diameters: 6.55mm (high flow) and 4.3mm (low flow).
General conditions Components Installation Service work Service menu
Components Holder for Barkey autoline XPT 4R
TSI
Holder
The holder for the sleeve warmer is designed to fix the Barkey autoline XPT 4R sleeve warmer.
General conditions Components Installation Service work
Functional description
Service menu TSI
➢
The Barkey autocontrol 3XPT controls the temperature of the warming devices by thermal sensors which are placed inside the warming sleeve.
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Heat transfer by silicon sleeve with integrated heating
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There are two sensors for controlling the temperature. One is close to the head and one is close to the end.
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The warmest of both sensors is used for controlling the temperature.
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Temperature is adjustable from 33°C up to 43°C. Default set-point is 41°C.
General conditions Components Installation Service work
Functional description
Service menu TSI
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Software overtemperature protection is adjusted to 1°C above the set-point.
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Hardware overtemperature protection is firmly set by resistors inside the connector.
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Hardware overtemperature is controlled by a separate temperature sensor inside the warming sleeve.
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Switch-off relay is located inside the Barkey autocontrol 3XPT.
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Parameters of the warming device are stored in an EEPROM inside the connector. ==> warming devices are interchangeable
General conditions Components Installation Service work
Content of the Technical training
Service menu TSI
•
General conditions for medical devices
•
Barkey Prismacomfort ➢
Components and functional description
➢
Installation and Operation (overview)
➢
Service work
➢
Service menu
➢
Technical Safety Inspection (TSI)
General conditions Components Installation Service work
Installation
Service menu TSI
➢
Fix the Barkey autocontrol 3XPT to the device holder by using the two screws of the device holder set
General conditions Components Installation Service work
Installation
Service menu TSI
➢
Route the power cable through the plastic clip and then behind the lower handle of the Prismaflex
General conditions Components Installation Service work
Installation
Service menu TSI
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Screw the special holder for the autoline XPT 4R to the right-hand side of the Prismaflex housing
General conditions Components Installation Service work
Installation
Service menu TSI
➢
Assemble the plastic clip to the mains cable cover of the Prismaflex