Terumo BCT T-SEAL MOBILE Скачать руководство пользователя страница 28

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DECLARATION OF CONFORMITY

PSPEC233 version 4

Terumo BCT, Inc.

10811 W. Collins Ave.,

Lakewood, CO 80215, USA

®: Registered trademark

Содержание T-SEAL MOBILE

Страница 1: ...LCT 7010en 12 2015...

Страница 2: ...we make no guarantee to this effect and would appreciate any observations regarding the contents of this document We may make improvements and alterations to the instrument and these changes will be...

Страница 3: ...on Procedure 11 6 FUNCTIONAL DESCRIPTION 12 6 1 Description of Sealing 13 6 2 Description of Equipment 13 6 3 Checking the Battery unit 14 7 OPERATING INSTRUCTIONS 15 7 1 Preparation before Use 15 7 2...

Страница 4: ...tubing into the slot at the front of the Hand unit to create a series of seals T SEAL MOBILE is comprised of a Hand unit and Battery unit which is connected to the Hand unit with the integrated cable...

Страница 5: ...arging Battery charger UL recognized component for Canada and U S A Symbol for CATALOGUE NUMBER Symbol for WARNING Follow instructions Symbol for SERIAL NUMBER Symbol for DATE OF MANUFACTURE Symbol fo...

Страница 6: ...be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the equipment or system should be observed to verify normal operation in the configuration in which it will...

Страница 7: ...A tubes connected to blood bags included either in Blood Packs or in Apheresis Disposable Sets The sealing can be performed when the donor is still connected to the Blood Pack or the Apheresis Disposa...

Страница 8: ...comprises the parts listed below Description Hand unit Battery unit Battery charger without plug Kit Primary Adaptors Part No 546900000 547900000 544900000 54410120 List of all cables and maximum leng...

Страница 9: ...Accessories Description Holster Extension cord 1 2 m 5 pol REF 8METSM004 8METSM005 4 4 User Interchangeable Parts Description Hand unit Battery unit Battery charger without plug Kit Primary Adaptors R...

Страница 10: ...e above list is subject to change refer to the packing list for accurate description of contents If any parts are missing or if the parts are damaged report it immediately 4 Please keep all shipping a...

Страница 11: ...mains voltages between 100 and 240 V AC 5 It takes about three hours to charge the Battery unit completely When the charging level indication on the unit indicates 100 and the recharge indication fla...

Страница 12: ...ectors and the indications are placed on the unit and their functions Front view of Battery unit Charge level indicator Recharge indicator Battery test button Hand unit Battery charger cable connector...

Страница 13: ...it detects controls and adjusts the necessary sealing activity to give the best sealing quality for the type of tubes that are being used See section 7 4 for a description of the different LED indicat...

Страница 14: ...ndicator lights up When the recharge indicator starts flashing the battery is fully charged and the charge current is automatically turned off The charge can be interrupted at any time without damage...

Страница 15: ...e 1 Place the instrument on a flat surface near the working place or in the holster 2 Check that there is sufficient battery capacity by pushing the TEST button 3 Connect the Hand unit cable into the...

Страница 16: ...ests some recommended actions Probable cause Recommended action Leaky or wet tube Dry the tube and try again Tiny arcs between the electrodes Dry the electrodes and try again Wet or dirty electrodes C...

Страница 17: ...oo low voltage Charge battery for 3 hours Fuse blown Contact your local Terumo BCT representative Other cause Contact your local Terumo BCT representative Charge Level LEDs do not light up during char...

Страница 18: ...ur local Terumo BCT representative Hard to divide tube after seal Moving electrode doesn t move smoothly in handle Clean and oil electrode shaft see chapter 9 2 Wet electrodes Dry the electrodes and t...

Страница 19: ...tion solution used remember to remove any residue to ensure that surfaces of the equipment are not subject to corrosion or discoloration Discard all materials in contact with blood according to instit...

Страница 20: ...r each cleaning Assemble the parts in reverse order Make sure the trigger and spring lock is in full forward position before electrode insertion Insert the moving electrode ensuring that it is positio...

Страница 21: ...ts including any warranty of merchantability or appropriateness for a particular purpose Terumo BCT s sole obligation and original purchaser s exclusive remedy for breach of warranty shall be limited...

Страница 22: ...collection and return systems available to you For more information on return recovery or recycling of T SEAL MOBILE please contact your local Terumo BCT Sales Office Technical support Call free numbe...

Страница 23: ...gnetic Environment Guidance RF emission CISPR 11 Group2 The T5460 T SEAL MOBILE must emit electromagnetic energy in order to perform its intended function Nearby electronic equipment may be affected R...

Страница 24: ...uld be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1kV line s to line s 2kV line s to earth 1kV 2kV Mains power quality should be that of a typical commercial or hospital...

Страница 25: ...rengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipm...

Страница 26: ...aximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 17 P 80 MHz to 800 MHz d 1 17 P 800 MHz to 2 5 GHz d 2 33 P 0 01 0 12 0 12 0 23 0...

Страница 27: ...27 DECLARATION OF CONFORMITY 12 DECLARATION OF CONFORMITY...