Introduction; Intended Purpose (Intended Use); Indications For Use; Intended Patient Population - Cardinal Health Kangaroo Omni 385400 Instructions For Use Manual

Introduction

Intended Purpose (Intended Use)

The Kangaroo OMNI™ Enteral Feeding Pump with Kangaroo OMNI™ Feeding Sets are intended for delivery of enteral
fluids, including nutritional fluids and/or water to the gastrointestinal system via nasogastric, orogastric, nasojejunal,
gastrostomy, and jejunostomy tubes. Not for use with neonates.

Indications for Use

The Kangaroo OMNI™ Enteral Feeding Pump with Kangaroo OMNI™ Feeding Sets are indicated for use in patients
ages infant and older who are physically unable to eat and swallow or who are unable to get sufficient nutrition
through eating and swallowing. The Kangaroo OMNI™ Enteral Feeding Pump and Feeding Set are intended to be used
together as a system. Kangaroo OMNI™ Enteral Feeding Sets for administration of standard formula are able to be
connected to access devices of all sizes that are ENFit™ compatible. The Kangaroo OMNI™ Thick Formula Feeding Sets
for administration of thick formula can be used with access devices 8 Fr size or greater that are ENFit™ compatible.

Intended Patient Population

Any patients ages infant, child/adolescent and adult who are physically unable to eat and swallow or who are unable
to get sufficient nutrition through eating and swallowing (see definitions under Glossary).

Intended Users/Use Setting

Kangaroo OMNI™ Enteral Feeding Pump and Kangaroo OMNI™ Feeding Set are intended to be used in hospital and
acute care settings, as well as long term and home care settings by users ranging from clinicians to laypersons and
patients. Some patients may need a caregiver to support using the device. The device is intended to be used in both
stationary and ambulatory conditions including ground and air transport while using the backpack accessory.

Clinical Benefit

This device facilitates the programmable and controlled delivery of enteral nutrition and hydration in patients who
have an intact gastrointestinal tract but are unable to meet nutrition needs via oral feeding. The device can administer
thick formula.
Kangaroo OMNI™ System Description
The Kangaroo OMNI™ Enteral Feeding Pump is a portable, rotary peristaltic pump. It can be programmed to provide
patients with continuous or intermittent feeding and/or hydration when used with Kangaroo OMNI™ Feeding Sets.
The feeding pump and its standard accessories (Kangaroo™ Power Cord with Adapter, Kangaroo™ Non-adjustable
Pole Clamp and feeding sets) are considered medical electrical equipment. The pump may also be used with
additional optional accessories like the Kangaroo™ Adjustable Pole Clamp, or Kangaroo™ Backpacks. The pump used
in conjunction with one or more of these optional accessories comprises the medical electrical equipment system. All
components in the system are suitable for use within the patient environment.
Safety & Warnings
Note to healthcare personnel who provide training to non-clinician care providers and/or patients:
Since patients and caregivers are intended operators, be sure to include all of the Warnings below when providing
training to lay users, especially in a Home Care Environment. Lay users should be instructed to contact Customer
Service if there is a change in the performance of Kangaroo OMNI™ Enteral Feeding Pump. Additionally, lay users
should be instructed on proper cleaning procedures to avoid hazards such as electric shock. Lay users should
also be trained on inappropriate environments for use (e.g. bathtub). For guidance on training, please contact
Customer Service.
When unpacking and installing the Kangaroo OMNI™ pump, accessories, and feeding sets, care should be taken
to minimize the environmental impact of waste, especially when disposing of packaging materials. Make sure to
follow local laws regarding disposal of packaging waste. Whenever possible, work to recycle cardboard, plastic, and
paper products.
This enteral feeding pump contains a lithium-ion battery pack. When discarding the pump at the end of its useful
life, remove the back label, unscrew the back housing from the pump, and unplug and remove the battery pack from
the pump. Dispose/recycle the battery pack in accordance with local laws. Avoid discarding lithium-ion batteries in
normal waste, as this may have environmental impacts. Note: Lithium-ion batteries contain stored energy that can
pose risk during disassembly. To reduce risk, wait until the pump indicates a low battery condition before removing.
Wear non-conductive gloves while handling. When removing the lithium-ion battery, do not puncture the cells or
packaging. Do not burn discarded battery packs as this can result in explosion.
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