Precision Medical EasyPulse5 Manual de usuario

USER MANUAL

1900 Series

(Threaded Connections)

SAVE THESE INSTRUCTIONS

CAUTION Federal (USA) law restricts this device to sale

by or on the order of a physician.

300 Held Drive Tel: (+001) 610-262-6090

Northampton, PA 18067 USA Fax: (+001) 610-262-6080

ISO 13485 Certified www.precisionmedical.com

CONTENTS

RECEIVING / INSPECTION................................................................. 2

INTENDED USE .................................................................................. 2

READ ALL INSTRUCTIONS BEFORE USING .................................... 2

EXPLANATION OF ABBREVIATIONS ................................................ 2

SAFETY INFORMATION - WARNINGS AND CAUTIONS ................... 3

PRINCIPLES OF OPERATION ............................................................ 5

SPECIFICATIONS ............................................................................... 6

DIAGRAMS / COMPONENT DESCRIPTION ...................................... 7

INSTALLATION.................................................................................... 8

OPERATING INSTRUCTIONS............................................................. 9

MAINTENANCE / CLEANING ........................................................... 11

RETURNS.......................................................................................... 11

DISPOSAL INSTRUCTIONS ............................................................. 11

TROUBLESHOOTING....................................................................... 12

REPLACEMENT PARTS.................................................................... 12

ACCESSORIES................................................................................. 13

LIMITED WARRANTY ....................................................................... 14

DECLARATION OF CONFORMITY................................................... 15

RECEIVING / INSPECTION

Remove the Precision Medical, Inc. EasyPulse5 Oxygen Conserving

Regulator (Conserver) from the packaging and inspect for damage. If

thereisanydamage,DONOTUSEandcontactyourEquipmentProvider.

INTENDED USE

To regulate high pressure cylinders that provide supplemental oxygen

to patients who may have difficulty extracting oxygen from the air they

breathe. It is for patients who would normally receive the oxygen via

a nasal cannula. The device delivers 100% oxygen at flow settings. It

is intended to be used as an oxygen saving device that reduces the

drying of the airways.

READ ALL INSTRUCTIONS BEFORE USING

This manual instructs the user to install and operate the EasyPulse5

Oxygen Conserving Regulator (Conserver). This is provided for your

safety and to prevent damage to the Conserver. If you do not understand

this manual, DO NOT USE the Conserver and contact your Equipment

Provider.

DANGER

This product is not intended as a life-sustaining or life-

supporting device

EXPLANATION OF ABBREVIATIONS

kPa Kilopascal

psi Pounds Per Square Inch

l/min Liters Per Minute

b/min Breaths Per Minute

SAFETY INFORMATION - WARNINGS AND CAUTIONS

DANGER Indicates an imminently hazardous situation

which, if not avoided, will result in death or

serious injury.

WARNING Indicates a potentially hazardous situation

which, if not avoided, could result in death or

serious injury.

CAUTION Indicates a potentially hazardous situation

which, if not avoided, may result in minor or

moderate injury.

CAUTION

Used without the safety alert symbol indicates

a potentially hazardous situation which, if not

avoided, may result in property damage.

OR CONSULT ACCOMPANYING DOCUMENTS

Symbol for “USE NO OIL”

Symbol for “NO SMOKING”

Symbol for “COVERING DEVICE WITH

GARMENTS WILL PRODUCE OXYGEN

ENRICHED ATMOSPHERE”

0473

Symbol indicates the device complies with the

requirements of Directive 93/42/EEC concerning

medical devices and all applicable International

Standards. (On CE marked Devices ONLY)

WARNING

• ALWAYS confirm prescribed dose before administering to

patient and monitor on a frequent basis.

• Always follow standards for Medical Gas Products, and High

Pressure Oxygen Handling. In the United States, ANSI, CGA

and G-4 applies.

• Keep cylinder valve closed at all times when cylinder is not in use.

• NO OXYGEN is delivered when the pointer is aligned with “OFF”.

• This Conserver is NOT to be used by patients who breathe

through their mouths.

• DO NOT use if dirt or contaminants are present on or around

cylinder, valve, the Conserver or connecting devices.

• DO NOT use oils, greases, organic lubricants or any combustible

materials on or near the Conserver. Wash and dry hands properly

prior to use.

• DO NOT use a humidifier with the Conserver.

• DO NOT allow cylinders to tip or fall. Secure gas cylinders

so they cannot fall. For optimum safety keep cylinder upright

whenever possible.

• DO NOT store cylinders near sources of heat or flame.

• DO NOT use while sleeping without consulting your Equipment

Provider.

• DO NOT smoke in an area where oxygen is being administered.

• DO NOT use near any type of flame or flammable/explosive

substances.

• Use only medical grade oxygen. In the United States, USP applies.

• The Conserver is equipped with a relief valve. If you hear a loud

hissingorpoppingsoundcomingfromtheConserver, discontinue

use, close cylinder valve, and contact your Equipment Provider.

• The Conserver is designed to operate with a single lumen, adult

cannula with a maximum length of 7 feet (2.1 m).

• The cannula is for single patient use only.

CAUTION

• Only personnel instructed and trained in its use should operate

e Conserver

• Th

e Conserver

contains magnetic, ferrous material that may

affect the results of an MRI.

• DO NOT autoclave.

• DO NOT gas sterilize with Ethylene Oxide.

• DO NOT clean with aromatic hydrocarbons.

• Store the Conserver in a clean area when not in use.

• Avoid dropping the

Conserver

or placing it in a position where it

could fall and become damaged.

• Consistent with the recommendations of the medical community on

theuseofconservingdevices,itisrecommendedthattheConserver

be qualified on patients in the situations it will be used.

• The Conserver may not be able to detect all respiratory efforts of the

patient. (Shallow breathers may not be able to trigger the Conserver.)

• Operating the Conserver outside its range of operating

conditions may affect its accuracy and performance.

PRINCIPLES OF OPERATION

The Oxygen Conserver is designed to be used with high-pressure

oxygen systems. It consists of a cylinder connection, cylinder contents

gauge (if equipped), high-to-low pressure regulator, orifice plate and a

conserving demand module. The regulator reduces the high pressure

of the cylinder to the working pressure of the orifice plate. The orifice

plate uses calibrated orifices to deliver a selected flow to the conserving

demandmodule.Theconservingdemandmodulecontrolsthepulsesize

and timing to the patient. It supplies a pulse of oxygen at the beginning

of each breath. This reduces the oxygen demand on the system and

limits the drying of the airways. The flow is determined by setting the

flow control knob to the prescribed flow. The oxygen is supplied to the

patient through the cannula.

SPECIFICATIONS

psi kPa bar

Inlet Pressure Range:

300 - 3000 2068 - 20684

20.68-206.84

Internal Regulated Pressure: 50 345 3.45

Pressure Gauge Accuracy: 3 - 2 - 3% of full scale

Dimensions: (are Approximate and may vary by model)

No Gauge Models Gauge Models

Weight: 10 oz (283 g) 12.6 oz (357 g)

Overall Length: 2.5 in (6.4 cm) 2.4 in (6.0 cm)

Width: 1.9 in (4.9 cm) 2.8 in (7.0 cm)

Height: 2.9 in (7.5 cm) 3.2 in (8.1 cm)

Pulse Settings: 1, 2, 3, 4, & 5 l/min Equivalents

Flow Settings: 2 l/min Continuous

Accuracy:

Pulse Volume: Within ± 15% of the nominal bolus value

(at each breath rate)

Continuous Setting: 2 l/min ± 10%

Savings Ratio: Up to 5.7:1

Trigger Method: Inspiratory effort (Negative pressure from

patient inhalation)

Breathing Frequency: UP to 35 b/min

Cannula Requirement: Maximum 7 foot (2.1 m) long standard

adult single lumen nasal cannula.

Operating Conditions:

Temperature: 35°F to 105°F (1.7°C to 40.6°C)

Altitude: Sea level to 10,000 ft (0 to 3,048 m)

Storage Conditions:

Temperature: -40°F to 140°F (-40°C to 60°C)

Maximum Humidity: 95% Non-condensing

Oxygen Cylinder Connection:

CGA 540 Valve

DIN 477 #6 Valve (Swedish Standard)

DIN 477 #9 Valve (German Standard)

British Bullnose Valve

Spanish Bullnose Valve

Ignition and Fault Tolerance: Meets ASTM G175-03

Specifications are subject to change without prior notice.

DIAGRAMS / COMPONENT DESCRIPTION

CAUTION

Missing or illegible labels must be replaced, contact Precision

Medical, Inc.

MODELS (3 versions shown)

CGA 540 Connection

195405 (Shown) and 194504NG Inlet Seal

(O-ring)

Green

Knob

Indicator

Pointer

Cannula

Connection

Dial

Contents Gauge

(Gauge Models

ONLY)

DIN 477 #6 Connection (Swedish Standard)

19SE05 (Shown) and 19SE05NG

(Labels are Green & White)

DIN 477 #9 Connection (German Standard)

19DE05 and 19DE05NG

(Labels are Black & White)

Inlet Seal

(O-ring)

Dial

Cannula

Connection

Contents Gauge

(Gauge Models

ONLY) Indicator

Pointer

White

Knob

Bullnose Connection

British - 19GB05 (Shown) and 19GB05NG

Spanish - 19ES05 and 19ES05NG

Cannula

Connection

Dial

Contents Gauge

(Gauge Models

ONLY)

Indicator

Pointer

White

Knob

Inlet Seal

(O-ring)

INSTALLATION

WARNING

• Read this User Manual before installing or operating the Oxygen

Conserving Regulator.

• Inspect the Conserver and cylinder valve to ensure they are free of

oils, greases or other contaminants.

• DO NOT direct flow of oxygen at any person, or flammable material

when cracking open the cylinder.

CAUTION

• Inspect the Oxygen Conserving Regulator for visual damage before

use, DO NOT USE if damaged.

• DO NOT use tools to tighten knob, this can lead to over tightening

and will cause damage to the Conserver.

• Be sure all connections are tight and leak free.

• DO NOT use liquid leak detector to test for leaks.

NOTE: For Operational Instructions on how to operate the cylinder

consult with your Equipment Provider.

1. Position the cylinder so the oxygen cylinder valve outlet is pointing away

from the user and any other person (s).

Before installing the Conserver, “crack” cylinder valve by opening the valve

slightly to remove any foreign particles and then close valve.

NOTE:

(For NO GAUGE (NG) Models ONLY) The Conserver should only

be used on cylinders with a contents gauge.

3. Be sure the Conserver is in the “OFF” position. Align “OFF” with the

indicating pointer .

Be sure the high pressure inlet connection has a seal.

DO NOT USE without a seal. (See Product Diagram)

NOTE:

For optimum safety, use only a Precision Medical, Inc.

Inlet Seal (Viton O-ring). (See Parts List)

The Inlet Seal supplied with the Conserver is reusable.

DO NOT USE any other type of seal.

5. Attach the Conserver to the oxygen cylinder valve.

6. Hand tighten knob clockwise until tight.

OPERATING INSTRUCTIONS

1. Attach a standard adult single Lumen oxygen nasal cannula, no

longer than 7 feet (2.1 m) to the Conserver’s outlet according to the

cannula manufacturer’s instructions.

WARNING

• DO NOT use pediatric, low flow nasal cannulas or oxygen masks

with the Conserver.

• DO NOT block the cannula connection or kink cannula tubing when

the Conserver is in use, this may damage the Conserver.

2. Place the cannula over your ears and position the prongs in your nose as

instructed by your Healthcare Provider or Cannula manufacturer.

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