Infinity MOOG-INFORNG Small Volume Enteral Feeding Pump Manuel utilisateur

OPERATOR’S MANUAL

i

Page

ENGLISH ...................................................................... ii

FRANCAIS .................................................................. 49

Innity® Orange® Operator’s Manual ii

TABLE OF CONTENTS

Page

TABLE OF CONTENTS ............................................................................................. i

PRODUCT OVERVIEW ............................................................................................ iii

INDICATIONS FOR USE ......................................................................................... iii

LIST OF WARNINGS AND CAUTIONS .................................................................. iv

Warnings .......................................................................................................................................... iv

1. PUMP COMPONENTS ......................................................................................... 1

Innity Orange Small Volume Enteral Feeding Pump ............................................... 1

Keypad .............................................................................................................................................. 3

Display .............................................................................................................................................. 4

Disposable Set .............................................................................................................................. 5

Symbols ............................................................................................................................................ 6

2. DIRECTIONS FOR USE ....................................................................................... 7

Priming and Loading the Disposable Set ........................................................................ 7

Operating the Pump

A Single Feeding Example ................................................................................................... 10

The Battery ..................................................................................................................................... 14

Running on Battery Power ................................................................................................ 14

Charging the Battery ............................................................................................................ 15

User Preference Settings .......................................................................................................... 16

ALARMS, MESSAGES, AND INDICATIONS .......................................................... 19

TROUBLESHOOTING GUIDE .................................................................................. 26

CLEANING ............................................................................................................... 29

ACCESSORIES .......................................................................................................... 30

SPECIFICATIONS ..................................................................................................... 33

IMPORTANT PEDIATRIC CONSIDERATIONS ........................................................ 35

ADDITIONAL TECHNICAL INFORMATION ........................................................... 36

WARRANTY ............................................................................................................. 38

LIST OF FIGURES ................................................................................................... 39

WHO TO CALL ........................................................................................................ 42

INDEX ...................................................................................................................... 43

iii

PRODUCT OVERVIEW

The Innity® Orange® is a rotary peristaltic enteral feeding pump designed to

deliver programmed doses of enteral nutrition solutions at selectable rates. It

is easy to use with a simple user interface and keypad. Moog technology allows

an accuracy rate of +/- 5% and the ability to safely operate in any orientation.

The Innity Orange system includes a complete line of delivery sets that are

made with materials that do not contain the plasticizer DEHP or natural rubber

latex. All Innity delivery sets feature automatic free-ow protection.

The Innity Orange is designed for both hospital and alternate site

care use. It is durable, water resistant, and easily carried in a Moog

carry pack. The Innity Orange’s size, weight, accuracy, and portability

promote and support health improving physical activity.

Enteral feeding is considered a medical procedure and following the instructions

for use in the Operator Manual is important for the pump to operate normally.

INDICATIONS FOR USE

The Innity Orange enteral feeding pump is a rotary peristaltic pump designed

to deliver programmed doses of enteral nutrition solutions at selectable rates.

Innity® Orange® Operator’s Manual iv

LIST OF WARNINGS AND CAUTIONS

Be sure to carefully read the following warnings and cautions. Failure to

review all the warnings and cautions can cause harm to the operator or

patient. Healthcare personnel who provide training to lay users should be

sure to review all the warning and cautions with the lay user. If there is a

change in the performance of the pump, contact customer service.

WARNINGS

4 Use ONLY feeding solutions prescribed by the responsible

physician, registered dietitian, registered nurse, or other licensed

practitioner. Failure to do so may result in harm to the patient.

4 Use ONLY Innity brand disposable sets to ensure proper uid

delivery. Others will not deliver the correct dose, may allow dangerous

free-ow conditions, and may generate hazardous uid pressures

which may activate occlusion alarms at unpredictable pressures.

4 Low ow rates, combined with high dose settings may exceed the life of the

disposable set. The disposable bag and screw cap sets must be replaced every

24 hours and the spike sets must be replaced every 48 hours (max 1.5 L) to

maintain delivery accuracy, allow proper air and occlusion sensing, and prevent

growth of bacteria. DO NOT PROGRAM RATE AND DOSE COMBINATIONS

WHICH EXCEED A 24 HOUR FEED REGIMEN FOR THE DISPOSABLE BAG AND

SCREW CAP SETS OR A 48 HOUR FEED REGIMEN FOR THE SPIKE SETS.

4 The battery capacity is an approximation. If you are unsure that

enough capacity remains for your intended use, recharge it. Failure

to do so may result in delayed or under-delivered therapy.

4 To avoid electrical shock, never clean pump with charger

plugged into an outlet or when pump is on.

4 To avoid electrical shock, make sure the Innity AC Adapter/Charger

is completely dry before plugging into an electrical outlet.

4 Do not use Innity Orange enteral feeding pump for delivery

of non-enteral solutions. Serious injury may result.

4 Proper operation of pump requires door to be closed and latched.

Make sure door is closed and latched when motor is running.

v

4 If an error occurs (ER01 - ER99 will appear in display), check all settings

and volume counters and verify before starting a feeding. Failure

to do so may result in delayed or under-delivered therapy.

4 No modication of this equipment is allowed including the pump,

disposable sets, and accessories. Modication can result in delayed

therapy, over or under delivery, electrocution, injury, or death.

4 Prior to starting the pump, conrm rate, dose, and food type are

programmed as prescribed to avoid an unsafe feeding condition.

4 Device contains small parts. Dispose of or store connector cap when

not in use to avoid choking hazard for children under 3 years.

4 Avoid leaving tubing and cords where infants, children, or those deemed at high

risk for medical line entanglement, can become entangled. Be aware that if these

items become wrapped around a patient’s neck, there is an increased risk of

strangulation or death. Caregivers of patients who are at risk for entanglement

should discuss with their health care provider how to properly manage their

lines and properly monitor patients based on their needs while in use.

Innity® Orange® Operator’s Manual vi

CAUTIONS

4 Federal law (U.S.A.) restricts this device to sale by or on the order of a physician,

registered dietitian, registered nurse, or other licensed practitioner.

4 Dispose of the Innity Pump, Innity Orange Pump and

Disposable Sets properly, as required by local law.

4 If any leaks are detected in the disposable set, stop pump operation

and disconnect set from patient and replace with a new disposable

set. Failure to do so may result in under-delivered therapy.

4 Care should be used when manually priming delivery set

to ensure cassette is not damaged by excess force.

4 Do not overload carry packs with personal items. Pump function may be

aected by kinked or pinched tubing and/or unintentional button presses.

4 The Innity Orange uses an optical air-in-line sensor to detect air in the

tubing as it passes through the pump, causing the pump to alarm if feeding

is inadvertently interrupted or when feeding is complete. It is important

to keep this sensor free of debris including spilled uids or food that may

adhere to the sensor and prevent proper detection of air in the tubing.

The clinician and caregiver should be trained regarding the care, use,

and maintenance of the Innity Orange pump and accessories, including

proper cleaning of the area around the optical air-in-line sensor.

4 Use ONLY commercially available pre-packed or commercially prepared

feeding solutions formulated for use with a feeding pump that are

prescribed by a licensed health care provider or dietitian.

4 DO NOT USE HOMEMADE BLENDERIZED OR LIQUIDIZED FOODS, OR OTHER

NON-PRESCRIBED, NON-COMMERCIALLY AVAILABLE FEEDING SOLUTIONS.

Use of homemade blenderized or other non-prescribed feeding solutions

may cause sticky solids which could cause an obstruction of the optical

sensor. It is recommended that all users clean and maintain the pump

and optical sensors according to manufacturer’s recommendations.

4 The use of commercially available blenderized formula (HCPCS Code:

B4149) can impact pump accuracy and performance. It is recommended

to follow the formula manufacture guidelines for pump use.

1. PUMP COMPONENTS

1

3

5

6

7

8

9

2

4

1. PUMP COMPONENTS

Innity Orange Small Volume Enteral Feeding Pump

1. Door

2. Pump Wheel

3. Display

4. Tab

5. Upstream Pressure Sensor

6. Air Sensor

7. Downstream Pressure Sensor

8. Receptacle for Cassette

9. Keypad

Figure 1-1 Pump: Front

Innity® Orange® Operator’s Manual 2

1. PUMP COMPONENTS

Innity Orange Small Volume Enteral Feeding Pump

1. Serial Number Label

2. Charger/Power Connector

3. Receptacle for Pole Clamp

4. Speaker

5. Pump Instruction Label

1

2

3

4

5

Figure 1-2 Pump: Rear

1. PUMP COMPONENTS

3

Keypad

Press ON/OFF key for 1.5 seconds to

either turn Innity Orange on or o.

Press and hold PRIME key to

rapidly ll disposable set with

uid. Release key to stop.

Press RUN/PAUSE key to start or

pause pump, or to clear an alarm.

Press FOOD TYPE key to display and select type of

food to be delivered (formula or human milk).

Press VOL/TOTAL key once to display volume delivered for current

feeding. Press key again to display total cumulative volume

delivered in all feed cycles since total volume was last cleared.

Press RATE/DOSE key to transition between rate

and dose settings, and to conrm settings.

Press CLEAR key to reset displayed function to its minimum

value. Press and hold for three seconds to clear rate, dose, and

volume delivered to minimum values at the same time.

Press + key to increase displayed feed function. Press

and hold key to increase value rapidly.

Press - key to decrease displayed feed function. Press

and hold key to decrease value rapidly.

NOTE: The following keys only function when pump

is in pause mode: PRIME, CLEAR, +, and -.

Figure 1-3 Keypad Layout

Innity® Orange® Operator’s Manual 4

1. PUMP COMPONENTS

Display

The display includes large alphanumeric

characters, as well as smaller symbols

and words. All segments and symbols on

the display are shown in Figure 1-4.

Settings and messages are displayed in large

alphanumeric characters (Figure 1-5).

When the large alphanumeric characters

display numbers, one of the smaller words

below the characters indicates which

function is being displayed (Figure 1-6).

The run symbol indicates pump

is running (Figure 1-7).

The wall plug symbol indicates the charger

is plugged in and connected to a live power

outlet. The battery symbol indicates pump

is running on battery power only. The

fuel gauge symbol indicates how much

battery charge remains (Figure 1-8).

NOTE: When operating on A/C power the

display light will remain on. When operating

on battery power the display light will

automatically turn o 10 seconds after the last

key is pressed. If you would prefer the light

to turn o when connected to an outlet, you

can change the pump light setting to OFF. See

the User Preference Settings section (Page

16) for instructions to change this setting.

Figure 1-4 Display Segments

Figure 1-5 Alphanumeric

Characters and Units

Figure 1-6 Setting Indicators

Figure 1-7 Run Indicators

Figure 1-8 Power Indicators

1. PUMP COMPONENTS

5

Disposable Set

The only disposable sets approved for use with Innity Orange pump are:

4 Innity Orange Screw Cap Set - Order Number INFOCAP-E

4 Innity Orange 100 ml Bag Set - Order Number INF0100-E

4 Innity 500 ml Bag Set - Order Number INF0500-E

4 Innity 1200 ml Bag Set - Order Number INF1200-E

4 Innity Safety Screw Spike Set - Order Number INF0020-E

1. Cassette

2. “ ” Symbol

3. Downstream Tubing

4. Upstream Tubing

5. 100 ml, 500 ml, or 1200 ml

Feeding Bag

6. ENFit connector

7. Protective cover

8. Screw Cap Set

9. Protective Cover for Safety

Screw Spike tip

10. Innity Safety Screw Spike

Figure 1-9 Innity Orange

100 ml Bag Set, or Innity

500 ml or 1200 ml Bag Set

21 3 4

5

6

7

Figure 1-11 Innity Safety Screw Spike Set 10

9

Figure 1-10 Innity

Orange Screw Cap Set

8

6

7

6

7

Innity® Orange® Operator’s Manual 6

1. PUMP COMPONENTS

Symbols

Brief instructions for operation of pump as well as a brief

explanation of each alarm message which pump may

communicate are printed on the label attached to pump.

These are not intended to be used in place of the Operator’s

Manual. They are simply a quick reference guide. Please read

the Operator’s Manual before operating the Innity Orange.

Consult

Accompanying

Documents

Figure 1-12 Consult

Accompanying Documents

The bag symbol is printed on pump door over

port where upstream tubing enters pump.

Figure 1-13 Feeding

Bag Connection

The patient symbol is printed on pump door over

port where downstream tubing exits pump.

Figure 1-14 Patient

Connection

EN 60601-1 Type BF degree of protection against electrical

shock. No electrical connection to patient. Drop from any

angle from height of 3 feet shall not damage pump operation.

Figure 1-15 TYPE BF

Shock Protection

EN 60529 degree of protection against water entering the

enclosure. Water jets from any direction shall have no eect. IP25 Figure 1-16 EN 60529

This symbol is printed on pump delivery sets. It indicates

only one patient should use each disposable set.

Figure 1-17 Single

Patient Use

This symbol is printed on pump delivery sets. It

indicates pump delivery sets are made with materials

that do not contain the plasticizer DEHP

Figure 1-18 DEHP-free

This symbol is printed on pump delivery sets. It indicates

pump delivery sets should be replaced every 24 hours.

Figure 1-19 Replace

Every 24 Hours

The Innity pump and delivery sets are made with

materials that do not contain natural rubber latex.

The Innity pump delivery sets are made with materials that

do not contain Bisphenol A (BPA) in the uid path.

2. DIRECTIONS FOR USE

7

2. DIRECTIONS FOR USE

Recommendation for First Use:

Since battery may not be fully charged when pump

is rst received, it is recommended that battery be

charged for 6 hours prior to operating on battery

power (see Page 15 for additional information).

Priming and Loading the Disposable Set

Step 1:

 4If you are using the Innity Safety Screw

Spike Set with a vented bottle or pre-lled

bag: Remove protective cover from tip, then

insert tip into formula exit port of container.

If using the Innity Safety Screw Spike Set,

secure the tip by tightly screwing threaded

components together. (Figure 2-1).

4 If you are using the 100ml, 500ml, or 1200ml

disposable set: Hold bag upright and pour in

feeding solution (Figure 2-2). Close cap securely.

4 If you are using the Screw Cap delivery set:

Fill a feeding bottle/container with a 40 mm

opening and secure it to the screw cap. Place

the bottle/container into the suspension bag

and secure the bag to an IV pole (Figure 2-3).

NOTE: Blenderized or aggressively mixed solutions may

have foam. If using this type of solution, allow it to sit

for 10 to 15 minutes before pouring into bag. This will

reduce the chance of an alarm due to air in the tubing.

Step 2:

Remove protective cover from transitional stepped

connector. If using pole clamp, protective cover may

be placed in the groove on back of clamp (Figure 2-4).

NOTE: If set is to be used with a carry pack, all

air must be removed from bag and tubing.

Continue to step 3 for instructions on

removing air. If set is to be hung above pump,

i.e. on an IV pole, you may skip to step 4.

Figure 2-1 Screw Tip Into Container

Figure 2-2 Fill Bag

Figure 2-4 Remove Cover from

Transitional Stepped Connector

/ Place Cover on Pole Clamp

Cover Receptacle

Figure 2-3 Fill Screw Cap Set

Innity® Orange® Operator’s Manual 8

2. DIRECTIONS FOR USE

Step 3:

Turn bag upside down and

gently squeeze. Tilt bag

as needed to keep air at

tubing port (Figure 2-5).

Step 4:

Gently pinch orange colored

tubing below “ ” symbol.

Hold this position until air is

removed from tubing. Gently

squeeze bag at same time to

assist uid ow. If uid does

not ow, pinch pressure may

be too strong. (Figure 2-6).

NOTE: Inside the orange

colored tubing, below the “ ”

symbol is the in-line occluder.

The in-line occluder is the

built-in anti free-ow valve.

By pinching tubing gently,

the tubing moves away

from the in-line occluder

allowing uid to ow (Figure

2-7). It is important to only

pinch the tubing below the “ ” symbol to avoid damaging the in-line occluder.

NOTE: Be extremely careful to pinch tubing using only the at, soft

part of your nger. Do not use ngernails when pinching tubing; doing

so may puncture the delivery set (Figure 2-8). If you suspect that the

delivery set has been punctured, please discard and use a new set

NOTE: Air may also be removed from tubing using the pump priming

feature. See step 7 for instructions on using the pump priming feature.

Figure 2-5 Squeeze Bag Figure 2-6 Pinch Tubing

Figure 2-7 Tubing

Segment Being Pinched

Figure 2-8 Tubing Segment

Being Punctured by Fingernail

2. DIRECTIONS FOR USE

9

Step 5:

Loop silicone tubing around pump wheel

stretching lightly. Place cassette into pump

(Figure 2-9). Close pump door (Figure 2-10).

NOTE: See pages 31-32 for pump use with a backpack.

Step 6:

Press and hold ON/OFF key for 1.5 seconds to

turn pump on. While pump runs through a self

test, display will light and an audible alarm will

sound as pump displays the nine digit serial

number three digits at a time for one second each.

The display will then show the letter ‘N’ followed

by a number, which is the software revision.

Next, all segments of display will be

shown for 2 seconds. Verify all display

segments and symbols are active.

The self test is complete and pump will then display

last programmed rate and will be in pause mode.

If any air is still in the tubing, continue to

Step 7 to use pump prime feature.

Step 7:

Press and hold PRIME key. Alarm will sound once

and pump will begin pumping at an approximate

rate of 360 ml/hr. Display will read “TO STOP LET GO”

(Figure 2-11). Once all air is removed from tubing,

release key. Pump will stop, display will revert to last

programmed rate, and pump will be in pause mode.

NOTE: occlusion and air in line alarms are disabled while priming

Figure 2-9 Seat Cassette

Figure 2-10 Close Pump Door

Figure 2-11 Priming Indication

Innity® Orange® Operator’s Manual 10

2. DIRECTIONS FOR USE

Operating the Pump

A Single Feeding Example

CAUTION: Please refer to pages vi for additional usage considerations.

If you want to deliver 50 ml of enteral feeding solution at

a rate of 100 ml/hr and then stop the pump:

Key Sequence for “A Single Feeding Example”

100 ml/h 50 ml

FORM ULA

HUMN MILK

Step 1:

Prepare the disposable set with enteral feeding solution as described in

the Priming and Loading the Disposable Set instructions (Page 7).

Step 2:

Hang feeding bag or container so that the bottom of bag is at

or above the level of the pump door (refer to page 35).

OR - If an Innity brand carry pack is to be used, load pump

and feeding bag into the proper compartments, securing

pump, bag and tubing with the pack’s straps (Page 31).

Step 3:

Turn pump on by pressing the ON/OFF

key. After running the self test, display

will show last programmed rate.

Step 4:

Press the + or - key to change the rate to 100 ml/hr.

Hold down either key to change rapidly (Figure 2-12).

Step 5:

Press the RATE/DOSE key to display dose. Press the +

or - key until a dose of 50 ml is displayed (Figure 2-13).

Figure 2-13 Program

Dose to 50 ml

Figure 2-12 Program

Rate to 100 ml/hr

2. DIRECTIONS FOR USE

11

Step 6

Conrm food type to be delivered (formula or

human milk) before starting pump by pressing

the FOOD TYPE key. Press the + or - key to

change between formula and human milk.

Step 7

Connect end of disposable set to the patient’s

enteral feeding tube (Figure 2-14).

Step 8

Press the RUN/PAUSE key. Pump will begin running.

Display will show programmed rate and the arcs

around the run symbol will rotate (Figure 2-15).

While pump is running, the following may

be viewed by pressing the appropriate

key: RATE, DOSE, and FOOD TYPE.

To view the amount delivered in the current feeding,

press the VOL/TOTAL key (Figure 2-16). This counter

will reset itself when the previously programmed dose

has been completed and a new feeding is started, or if

a feeding is interrupted and Rate or Dose is changed.

To view the amount delivered over the course

of several feedings press the VOL/TOTAL key

a second time. Display will read TOTL then the

amount. This counter never resets itself. It can

only be reset by the user (Figure 2-17).

While pump is running, the settings cannot be

changed and the Prime feature is disabled.

If you want to stop pump at any time, press the

RUN/PAUSE key. Display will show rate, and

pump will be in pause mode. Pump will save the memory of where it was in the

feeding before being paused. Or, turn pump o by pressing the ON/OFF key.

Figure 2-17 Total

Amount Delivered

Figure 2-15 Pump is Running

Figure 2-16 Amount

Currently Delivered

Figure 2-14 Connect disposable

set to feeding tube

Innity® Orange® Operator’s Manual 12

2. DIRECTIONS FOR USE

To restart pump when in paused mode, press the RUN/PAUSE key. The

pump will restart the feeding at the point where it was paused.

NOTE: If pump is turned o and turned back on again, the volume delivered

counter resets to 0 and food type resets to formula. Rate, dose, and food

type must be conrmed before restarting the pump with a new feeding.

NOTE: ANY CHANGES TO PUMP SETTINGS EXCEPT FOOD TYPE DURING

A FEEDING CYCLE WILL CAUSE PUMP TO START A NEW FEEDING; IT WILL

NOT START WHERE IT LEFT OFF. RATE, DOSE, AND FOOD TYPE MUST BE

CONFIRMED BY VIEWING EACH PARAMETER BEFORE RESTARTING THE PUMP.

Feeding Completion:

When the dose has been completely delivered, pump will stop running, and display

will read DOSE DONE. Pump will be in a pause mode until it is turned o or feeding is

restarted. To clear DOSE DONE, press and hold the ON/OFF key for 1.5 seconds to turn

pump o, or press the RUN/PAUSE key to put pump in pause mode. Adjustments

to settings can be made at this time, or press the RUN/PAUSE key a second time to

start another feeding using same rate, dose, and food type settings. Conrmation

of rate, dose, and food type is required before beginning another feeding.

If you would prefer the alarm to sound when the

dose is complete, you can change the pump dose

complete alarm setting to BEEP WHEN DONE. See

the User Preference Settings section (Page 16) for

instructions to change this setting. When set to

BEEP WHEN DONE, the pump will stop at the end

of the feeding, beep intermittently, and display

will read DOSE DONE (Figure 2-18). To silence alarm

when the dose is complete, press and hold the ON/

OFF key for 1.5 seconds to turn pump o, or press

the RUN/PAUSE key to put pump in pause mode. Figure 2-18 DOSE DONE

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Infinity MOOG-INFORNG Small Volume Enteral Feeding Pump Manuel utilisateur

Infinity MOOG-INFORNG Small Volume Enteral Feeding Pump Manuel utilisateur

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