Inspire Sleep Apnea Innovation

Explanation of Symbols on Product or Package Labeling

[Caution]

Caution, consult accompanying documents

[Information]

Consult electronic instructions for use

[USA Regulatory Symbol]

For USA audiences only

[USA Regulatory Symbol]

Caution: Federal Law (USA) restricts this device to sale on or by the order of a physician

[Do Not Reuse]

Do not reuse

[Sterile EO]

Sterilized using ethylene oxide

[MR Conditional]

The Inspire therapy system is Magnetic resonance (MR) conditional

[Damaged Package Warning]

Do not use if the package is damaged

[Open Here]

Open Here

[Manufacturer Symbol]

Manufacturer

[Date of Manufacture]

Date of manufacturing

[Use By Date]

Use by

[Serial Number]

Serial number

[Reference Number]

Reference number

[Temperature Limit]

Temperature limitation

[SENSE Port Connector]

Lead that inserts into SENSE (sensing) port of implantable pulse generator (IPG)

Trademark and Patents

The following is a trademark of Inspire Medical Systems, Inc.: Inspire^®.

This product and/or the use of this product in a method may be covered by one or more patents or patent applications, available at www.inspiresleep.com/patents.

Device Description

The Inspire^® Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membrane that converts the mechanical energy of respiration into an electrical signal. The lead incorporates a standard connector for coupling to the implantable pulse generator (IPG).

Figure 1: Respiratory sensing leads, 25cm (Top) and 45cm (Bottom)

The diagram shows two lead configurations. The 25cm Lead includes sealing rings, an anchor labeled 'distal', an anchor labeled 'proximal', and a connector pin. The 45cm Lead also features sealing rings, a sensor membrane, a lead body, and a sigmoid lead body, connecting via a connector pin.

Instructions for Use

Refer to the Inspire System Implant Manual for information on indications, contraindications, clinical warnings/precautions, clinical summary, and instructions for use. Contact Inspire Medical Systems at the address on the back cover of this document for a copy of the Inspire System Implant Manual.

Contents of Package

The lead and accessories are supplied sterile. The package contains:

• One respiratory sensing lead
• Product literature

Specifications

Inspire Medical Systems Limited Warranty

Summary

Inspire provides a limited warranty against defects. The warranty period for implanted products is 3 years. All other products have a warranty period of 2 years or less. This information is intended for doctors but provided for reference.

Exclusions and Limitations

Implied warranties for tools are excluded. Inspire Medical Systems is not liable for damages from tool defects, failures, or malfunctions. No person can bind Inspire Medical Systems to any representation or warranty except those stated herein.

For products other than tools, this limited warranty applies if products fail to function within normal tolerances due to defects in materials or workmanship during the specified warranty period.

For patient products (IPG, lead, Inspire Sleep Remote), Inspire Medical Systems will issue a credit to the hospital conducting replacement surgery. For physician products (e.g., programmer), credit is issued to the original purchaser.

Terms and Conditions

1. Product labeling must indicate a limited warranty exists.
2. For implantable products, warranty applies only for product replacement in the original patient.
3. Registration materials must be completed and returned within 30 days of first use.
4. The product must be replaced with an Inspire Medical Systems product.
5. Implantable products must be implanted before expiry and with other Inspire Medical Systems products.
6. Products must be returned to Inspire Medical Systems, 5500 Wayzata Blvd, Suite 1600, Golden Valley, MN 55416 within 30 days of first failure to function within normal tolerances. Contact your Inspire Medical Systems representative for return instructions.
7. Inspire Medical Systems will inspect returned products to determine warranty credit eligibility.
8. All returned products become the property of Inspire Medical Systems.

This limited warranty represents Inspire Medical Systems' entire obligation for products other than tools and is made in lieu of any other warranties, express or implied, including MERCHANTABILITY or fitness for a particular purpose.

This limited warranty grants specific legal rights, which may vary by state.

Limited Warranty Period

Within the United States:

• Three (3) years from date an IPG or lead is implanted in the patient.
• One (1) year from the date a physician programmer or Inspire Sleep Remote is first used.

Outside the United States:

• Three (3) years from date an IPG or lead is implanted in the patient.
• Two (2) years from the date a physician programmer or Inspire Sleep Remote is first used.

Manufacturer Information

Manufacturer

Inspire Medical Systems, Inc.
5500 Wayzata Blvd, Suite 1600
Golden Valley, MN 55416
USA

Tel. 1-844-672-4357 or 763-205-7970
Fax 763-537-4310
www.inspiresleep.com

© Inspire Medical Systems 2022
All Rights Reserved
200-375-101 Rev A