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Instructions for use of this Bone Marrow Aspiration Needle

A.  INTENDED USE

The Bone Marrow Aspiration Needle is intended for use in aspirating 

bone marrow specimen.

B.  CONTRAINDICATIONS

For use only for bone marrow aspiration as determined by a li-

censed physician. The device is intended to be used by a physician 

familiar with the possible side effects, typical findings, limitations, 

indications and contraindications of bone marrow aspiration. The 

procedure should be performed on patients that are suitable for 

such procedure only.

Caution: 

For single patient use only. Do not attempt to clean or 

resterilize this product. The design of this device may not perform 

as intended by the manufacturer if it is reused. The manufacturer 

cannot guarantee the performance, safety and reliability of a repro-

cessed device.

After use, this product may be a potential biohazard. Handle in a 

manner which will prevent accidental puncture. Dispose in ac-

cordance with applicable laws and regulations. Carefully place the 

used needle in a sharps biohazard container after the procedure is 

completed.

Note: 

These instructions are NOT meant to define or suggest any 

medical or surgical technique. The individual practitioner is respon-

sible for the proper procedure and techniques to be used with this 

device.

C.  DIRECTIONS FOR USE

1.  Inspect the package for proper integrity. If undamaged, open 

the package using aseptic technique.

2.  Remove the needle from the pouch and inspect the cutting 

edge of both cannula and stylet for any damage or other imper-

fections that would prevent the proper operation of the needle.

3. 

Following proper placing technique, locate the needle adjacent 

to the biopsy site.

4. 

Using gentle (but firm) pressure, advance the needle by 

rotating in an alternating clockwise-counterclockwise mo-

tion. Entrance into the marrow cavity is generally detected by 

decreased resistance.

Содержание magellan

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Страница 2: ...cident 4 The Product may not have been used by any other customer C This Limited Warranty is limited to its express terms In particular 1 Except as expressly provided by this Limited Warranty ARTERIOC...

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Страница 12: ...ED STATES A This LIMITED WARRANTY provides assurance for the customer who receives an Arteriocyte Medical Systems AMS Magellan Ratio Dispenser Kit Product that should the Product fail to function to s...

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Страница 14: ...ntial UWHULRF WH 0HGLFDO 6 VWHPV QF OO 5LJKWV 5HVHUYHG 06 5HY AMS95030LBL Rev 2 AMS95030LBL Rev 2 AMS95023LBL Rev 2 AMS95125LBL Rev 2 AMS95125LBL Rev 2 Arteriocyte Medical Systems Inc 2011 Manufacture...

Страница 15: ...MAGELLAN Aspiration Kit Instructions For Use...

Страница 16: ......

Страница 17: ...on Consult Accompanying Documents l Lot Number j Catalog Number p Sterilized Using Ethylene Oxide Latex Free Nonpyrogenic k Do Not Reuse f Use by F Fragile Handle with Care H This Way Up _ Quantity Ph...

Страница 18: ...only Arteriocyte Medical Systems disposable accessories Inspect the kit prior to use Do not use the kit if any component of the tray is damaged or opened Precautions 1 Only Arteriocyte Medical Systems...

Страница 19: ...Kit consists of the following compo nents Two 2 30 mL Syringes One 1 60 mL Syringe One 1 200 Micron Blood Component Filter One 1 Bone Marrow Aspiration Needle One 1 3 Way Stopcock One 1 18 G Needle F...

Страница 20: ...l tubing just to luer connector to de air tubing and close pinch clamp 4 Attach the collection syringe to distal tubing luer connector of the filter and open pinch clamp 5 Gently pull back on the plun...

Страница 21: ...ay be a potential biohazard Handle in a manner which will prevent accidental puncture Dispose in ac cordance with applicable laws and regulations Carefully place the used needle in a sharps biohazard...

Страница 22: ...nges because they may result in an inadequate seal and may break and fragment 7 Apply negative pressure by quickly withdrawing the syringe plunger Disengage the syringe and remove the aspirated sample...

Страница 23: ...e lesser of the net invoiced price of the original or current functionally comparable or replacement Product B To qualify for the Limited Warranty these conditions must be met 1 The Product must be us...

Страница 24: ...rceable or in conflict with applicable law by a court of competent jurisdic tion the validity of the remaining portions of the Limited War ranty shall not be affected and all rights and obligations sh...

Страница 25: ......

Страница 26: ...teriocyte Medical Systems Inc 45 South Street Hopkinton MA 01748 USA Internet www arteriocyte com Toll free 1 866 660 AMSI 2674 Fax 508 497 8951 Arteriocyte Medical Systems Inc All Rights Reserved AMS...

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