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Sam IO Driver User Manual

Sam IO Driver
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EN
SAM IO Driver | Instructions for Use
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Sam IO Driver Specifications

General IconGeneral
BrandSam
ModelIO Driver
CategoryMedical Equipment
LanguageEnglish

Summary

Product Information Overview

Product Description

The SAM IO Intraosseous Access System uses a manually operated driver handle with a trigger assembly for rotational spin to place the SAM IO needle assembly.

Product Identification Details

Details driver part number (10700-EN) and applied parts (SAM IO Intraosseous Access needles: 15 mm, 25 mm, 45mm).

Safety Information and Consultations

Contains indications, contraindications, warnings, precautions and other safety information for the SAM IO Intraosseous Access System.

User Information and Recommendations

Usage Recommendations and Restrictions

Use in accordance with manual, no unauthorized adjustments/repairs, avoid connecting to non-SAM Medical products.

Pre-Use Inspection and Cleaning

Inspect driver for damage. If soiled, follow cleaning procedures. Maintain PPE precautions.

Continued User Information and Warnings

Cleaning, Disinfection, and Inspection

Inspect after cleaning for debris/damage. Use approved disinfectant solutions; avoid immersing in liquid.

Product Viability and Damage Assessment

No known expiration unless mechanically damaged. Actuate driver before use to check viability.

Insertion Force and Bone Penetration

Do not use excessive force. Mechanical rotation and cutting edge are primary for bone penetration, not downward pressure.

Driver Failure Contingency Plan

In case of driver failure, the needle assembly can be used manually. Refer to SAM IO Needle Instructions.

Critical Usage Restriction: Sternal

This device is not approved or intended for use on the sternum.

Symbol Glossary and Identification

Information and Identification Symbols

Symbols for prescription use, consulting instructions, manufacturer, and batch/catalog identification.

Cautionary Information and Restrictions

Symbols for important warnings, sternal use restriction, and non-sterile status.

Symbol Glossary Details

Regulatory and Identification Markings

Symbols indicating prescription use, manufacturer, batch code, catalog number, and EU directive compliance.

Safety and Usage Symbols

Symbols for consulting instructions, important cautions, sternal use restriction, and non-sterile device.

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