0 introduction, 1 equipment provider responsibility – AirSep MN134-1 B User Manual

Page 6

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MN134-1 rev B

02/14

1

1.0 Introduction

1.1 Equipment Provider Responsibility

All Equipment Providers of the NewLife

®

Intensity 10 Oxygen Concentrator must assume

responsibilities for handling, operational check-out, patient instruction, and oxygen
concentration checks. These responsibilities are outlined below and throughout this
manual.

As an Equipment Provider, you must do all of the following:

§

Inspect the condition of each NewLife Intensity 10 unit immediately upon delivery

to your business location. Note any sign of damage on the delivery receipt, and
report it directly to both the freight company and AirSep Corporation immediately.

§

Check the operation of each NewLife Intensity 10 before delivery to a patient.

Confirm the oxygen concentration level is within specifications, as referred to in
Section 2.4. (Test the battery and power disconnect alarm, as described in Section
2.3 of this manual.)

§

Deliver NewLife Intensity 10 units only to patients authorized by a licensed health

care provider or physician’s prescription. The NewLife Intensity 10 must not be
used as a life-supporting device. A backup supply of oxygen must be available.

§

Instruct patients how to use the NewLife Intensity 10 in conjunction with the Patient

Manual.

§

Instruct patients to notify their licensed health care provider/physician if they

experience any signs of discomfort.

§

Instruct each patient how to perform routine maintenance of the air intake gross

particle filter and how to check the alarm system battery. (Refer to Section 3.2.)

§

Be available to provide service to each patient at any time.

§

Maintain the NewLife Intensity 10 in accordance with Section 4.0.

§

Establish and implement a protocol to check oxygen concentration.

§

Repair components and replace parts only as outlined in this manual. Use only

AirSep parts for replacement in NewLife Intensity 10 Oxygen Concentrators.

This unit is not a life-support device. Geriatric, pediatric, or any other
patient unable to communicate discomfort while using this oxygen
concentrator may require additional monitoring. Patients with hearing
and/or sight impairments may need assistance with monitoring the
alarms.

This device supplies high-concentration oxygen that promotes rapid
burning. Do not allow smoking or open flames within the same room of
(1) this device, or (2) any oxygen-carrying accessory. Failure to observe
this warning can result in severe fire, property damage, and/or cause
physical injury or death

.


Use no oil, grease, or petroleum-based or other flammable products on
or near nasal end of cannula or on the Intensity 10 unit. Oxygen
accelerates the combustion of flammable substances.

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