SAM Junctional Tourniquet Instruction Manual

: June 4, 2024
: SAM

Table of Contents

TO CONTROL DIFFICULT BLEEDS IN THE INGUINAL AREA
TO CONTROL DIFFICULT BLEEDS IN THE AXILLA AREA
TO IMMOBILIZE A PELVIC FRACTURE
INTENDED USE
INDICATIONS FOR USE
WARNINGS
**
UNDESIRABLE SIDE EFFECTS
CLINICAL INFORMATION FOR USERS
SYMBOL GLOSSARY
Documents / Resources

SAM Junctional Tourniquet

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SAM Medical Products® 12200 SW Tualatin Rd., Suite 200 Tualatin, OR 97062, USA +1 503.639.5474|
Emergo Europe, Prinsessegracht 20, 2514 AP, The Hague, The Netherlands

TO CONTROL DIFFICULT BLEEDS IN THE INGUINAL AREA

Slide the belt underneath the patient, positioning the Target Compression Device (TCD) over the area to be compressed. Use sterile gauze or hemostatic dressing if targeting directly over a wound. For bilateral application use a second TCD.
Hold the TCD in place and connect the belt using the buckle.
Pull the BROWN HANDLES away from each other until the buckle secures.
You will hear an audible click. Fasten excess belt in place by pressing it down on the Velcro. You may hear a second click once the belt is secure.
Use the hand pump to inflate the TCD until hemorrhage stops.
Monitor patient during transport for hemorrhage control and adjust the device if necessary.
TO REMOVE, unbuckle the belt.

TO CONTROL DIFFICULT BLEEDS IN THE AXILLA AREA

Apply the SJT to the patient under the arms, as high as possible. Place the D-ring on the injured side, aligning it with the side of the neck. Connect the buckle and secure the strap in place by pulling the BROWN HANDLES apart until you hear it click.
Attach the Extender to the TCD prior to application and place on the strap on the brown Velcro.
Connect the strap using the large clip to the D-ring on the front of the SJT.
Connect the auxiliary strap to the cord on the back of the SJT using the small clip, as close as possible to the patient’s mid-line.
Tighten the strap as much as possible using the BROWN HANDLE. Use the pump to inflate the TCD until hemorrhage stops.
Monitor patient during transport for hemorrhage control and adjust the device if necessary.
TO REMOVE, unbuckle the belt.

TO IMMOBILIZE A PELVIC FRACTURE

Remove objects from patient’s pockets or pelvic area. Slide the belt,
without the TCD, underneath the patient at the level of the trochanters
(hips)
Connect the belt using the buckle.
Pull the BROWN HANDLES away from each other until the buckle secures. You will hear an audible click. Fasten excess belt in place by pressing it down on the Velcro. You may hear a second click once the belt is secure. In case of prolonged use, monitor patient’s skin.
When used as a pelvic sling, the SJT should remain firmly attached to the patient while in the MRI room.

TO REMOVE, unbuckle the belt.

INTENDED USE

SAM Junctional Tourniquet is intended to control junctional bleeding for up to 4 hours where standard tourniquets cannot be used.

INDICATIONS FOR USE

SAM Junctional Tourniquet is indicated for battlefield and trauma situations:

To control difficult bleeds in the inguinal area
To control difficult bleeds in the axilla area
To immobilize a pelvic fracture

WARNINGS

Additional hand pumps may be necessary with changes in altitude. If altitude change is a concern, a syringe can be used to fill the TCD with water, saline or other non-compressible fluid.

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PRECAUTIONS**

SAM Junctional Tourniquet is intended to be left on for up to four hours.
Remove objects from patient’s pockets and clothing prior to application.
In case of prolonged use as a pelvic sling, monitor the patient’s skin for pressure injury.
Device is single use only.
Reuse of device may cause illness (e.g., infection) or injury (reduced performance).
Dispose of used device per healthcare facility biohazard protocol
When used as a pelvic sling the SJT should remain firmly attached to the patient while in the MRI room.

UNDESIRABLE SIDE EFFECTS

Tourniquet application may cause considerable pain.
Application of the tourniquet may cause skin, muscle, vessel or nerve damage.

CLINICAL INFORMATION FOR USERS

SAM Junctional Tourniquet and IFU familiarization and training as well as adherence to healthcare organization evidence-based standards of care and clinical guidelines including use of PPE, are required for safe use of this product. Failure to utilize this device in a manner consistent with the IFU, training, and within clinical best practice guidelines, may result in serious illness or injury.

Notice to Users / Patients:
Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

SYMBOL GLOSSARY

Manufacturer|
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Batch Code|
MR Conditional|
Caution|
Prescription Only in the USA|
Catalog Number| **
Medical Device|
Non Sterile Product|
Do Not Reuse| **
CE Mark|
Authorized Representative in the European Community|
Consult instructions for use. eIFU available at:sammedical.com/eIFU|
Importer|
| JT400 – SJT Belt | 2 TCD | Ext. | Hand Pump | Aux. Strap
NSN# 6515-01-618-7475 / NSN# 6515-01-646-2617
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| JT401 – SJT Belt | 1 TCD | Hand Pump