Precision Medical EasyPulse 5 Manuale utente
USER MANUAL
1900 SERIES
(CGA 870 Connection)
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
1
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
COMPONENT DESCRIPTION ............................................................ 7
INSTALLATION.................................................................................... 8
OPERATING INSTRUCTIONS............................................................. 9
MAINTENANCE / CLEANING ........................................................... 11
RETURNS.......................................................................................... 11
DISPOSAL INSTRUCTIONS ............................................................. 12
TROUBLESHOOTING....................................................................... 12
REPLACEMENT PARTS.................................................................... 13
ACCESSORIES ................................................................................ 13
LIMITED WARRANTY ....................................................................... 14
2
RECEIVING / INSPECTION
Remove the Precision Medical, Inc. EasyPulse5 Oxygen Conserving
Regulator (Conserver) from the packaging and inspect for damage. If
there is any damage, DO NOT USE and contact your Provider.
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
ThismanualinstructsausertoinstallandoperatetheOxygenConserving
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 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
3
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”
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)
4
WARNING
• ALWAYS confirm prescribed dose before administering to
patient and monitor on a frequent basis.
• Always follow ANSI and CGA standards for Medical Gas
Products and Oxygen Handling (G-4).
• Keep cylinder valve closed at all times when cylinder is not in use.
• NO OXYGEN is delivered when the pointer is aligned with
“OFF”, or between settings.
• 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, product or connecting devices.
• DO NOT use oils, greases, organic lubricants or any
combustible materials on or near this product. Wash and dry
hands properly prior to usage.
• 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 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 USP grade medical oxygen.
• The Conserver is equipped with a relief valve. If you hear a
loud hissing or popping sound coming from the product,
discontinue use of product, close cylinder valve, and contact
your 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.
5
CAUTION
• Only personnel instructed and trained in its use should
operate the Conserver.
• The 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 the use of conserving devices, it is recommended that the
Oxygen Conserving Regulator 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
demand module. The conserving demand module controls the pulse size
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.
6
SPECIFICATIONS
Inlet Pressure Range: 300 - 3000 psi (2068 - 20684 kPa)
Internal Regulated Pressure: 50 psi (345 kPa)
Pressure Gauge Accuracy: 3 - 2 - 3% of full scale
Dimensions: (Are approximate and may vary by model)
Model: 198705
Weight: 9.9 oz (279 g)
Overall Length: 4.75 in (12.07 cm)
Width: 2.63 in (6.67 cm)
Height: 2.50 in (6.35 cm)
Pulse Settings: 1, 2, 3, 4, & 5 l/min Equivalents
Flow Settings: 2 l/min Continuous
Accuracy:
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% Noncondensing
Oxygen Cylinder Connection:
CGA 870 Valve
Ignition and Fault Tolerance:
Meets ASTM G175-03
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COMPONENT DESCRIPTION
CAUTION
Missing or illegible labels must be replaced, contact Precision
Medical, Inc.
Index
Pins
Yoke
Seal
Cannula
Connection
T-Handle
Dial
Contents
Gauge
Indicator
Pointer
8
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.
• DO NOT use without yoke seal.
• DO NOT use plastic yoke seals.
• Use Precision Medical, Inc. yoke seal made of viton and brass.
• The yoke seal supplied with the Conserver is reusable.
CAUTION
• Inspect the Oxygen Conserving Regulator for visual damage
before use, DO NOT USE if damaged.
• DO NOT use tools to tighten T-handle, 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 your Provider.
1. Position the cylinder so the oxygen cylinder valve outlet is pointing
away from the user and any other person(s).
2.
Before installing the Conserver, “crack” cylinder valve by opening the
valve slightly to remove any foreign particles and then close valve.
3. Be sure the Conserver is in the “OFF” position. Align “OFF” with
the indicating pointer .
4.
Be sure the CGA 870 connection high pressure inlet has a yoke seal.
5. Align Index Pins with Index Pin Alignment Holes in Post Valve.
6. Hand tighten T-handle until snug.
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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.
CAUTION
• 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 Provider or cannula manufacturer.
OR
3.
Slowly open cylinder valve counterclockwise, until completely open.
4. Turn dial on the Conserver until indicating pointer is aligned with
the prescribed setting.
5.
Breathe through your nose and feel a pulse of oxygen as you inhale.
NOTE: •
When on a pulse setting, there is flow or a pulse only at
the beginning of each breath. If you do not feel the pulse
at the beginning of each breath, check the setting. If there
is still no pulse, turn dial to “2 l/min Continuous” setting.
•Because each patient’s breathing pattern is different
and the environment varies, it may be difficult to feel
some low setting pulses.
Indice
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