Precision Medical 1900 EasyPulse5, EasyPulse5, EasyPulse5, EasyPulse5, EasyPulse5, EasyPulse5, EasyPulse5, EasyPulse5, EasyPulse5, EasyPulse5 Oxygen Conserving Regulator User Manual
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U S E R M A N U A L
1900 Series
(Threaded Connections)
CAUTION
SAVE THESE INSTRUCTIONS
Federal (USA) law restricts this device to sale by or on the order of a physician.
300 Held Drive
Northampton, PA 18067 USA
ISO 13485 Certified
Tel: (+001) 610-262-6090
Fax: (+001) 610-262-6080
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
1
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 Equipment 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
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 lifesupporting device.
ExPLANATION OF ABBREVIATIONS
kPa psi l/min b/min
Kilopascal
Pounds Per Square Inch
Liters Per minute
Breaths Per minute
2
SAFETY INFORMATION - WARNINGS ANd CAUTIONS
dANGER
WARNING
CAUTION
CAUTION
Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.
Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury.
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”
0473
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)
3
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 hissing or popping sound coming from the Conserver, 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.
4
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 Conserver 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.
5
SPECIFICATIONS
Inlet Pressure Range:
Internal Regulated Pressure:
Pressure Gauge Accuracy: psi
50
kPa
300 - 3000 2068 - 20684
345
3 - 2 - 3% of full scale
dimensions: (are Approximate and may vary by model)
bar
20.68-206.84
3.45
Weight:
Overall Length:
Width:
No Gauge Models Gauge Models
10 oz (283 g)
2.5 in (6.4 cm)
1.9 in (4.9 cm)
12.6 oz (357 g)
2.4 in (6.0 cm)
2.8 in (7.0 cm)
Height: 2.9 in (7.5 cm) 3.2 in (8.1 cm)
Pulse Settings:
Flow Settings:
Accuracy:
Pulse Volume:
Continuous Setting:
Savings Ratio:
Trigger Method:
1, 2, 3, 4, & 5 l/min Equivalents
2 l/min Continuous
Within ± 15% of the nominal bolus value
(at each breath rate)
2 l/min ± 10%
Up to 5.7:1
Inspiratory effort (Negative pressure from patient inhalation)
Breathing Frequency:
Cannula Requirement:
UP to 35 b/min maximum 7 foot (2.1 m) long standard adult single lumen nasal cannula.
Operating Conditions:
Temperature:
Altitude:
Storage Conditions:
Temperature:
35°F to 105°F (1.7°C to 40.6°C)
Sea level to 10,000 ft (0 to 3,048 m) maximum Humidity:
-40°F to 140°F (-40°C to 60°C)
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.
6
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
Cannula
Connection
Inlet Seal
(O-ring)
Dial
Contents Gauge
(Gauge models
ONLY)
Indicator
Pointer
Cannula
Connection
Green
Knob
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
Contents Gauge
(Gauge models
ONLY)
Indicator
Pointer
7
White
Knob
Cannula
Connection
Bullnose Connection
British - 19GB05 (Shown) and 19GB05NG
Spanish - 19ES05 and 19ES05NG
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.
8
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.
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 .
4. 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.
OR
9
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 the nose, you should 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.
6. To remove the Conserver from cylinder:
• Completely close oxygen cylinder valve clockwise.
• Turn the Conserver dial to “2 l/min continuous” position.
• Wait for oxygen to stop flowing from Conserver.
•
Remove Conserver from cylinder valve.
dANGER
NEVER attempt to remove the Conserver from a cylinder unless the cylinder valve is closed.
WARNING
• When cylinder pressure is 500 psi (3447 kPa, 34.47 bar) and below, it is recommended to change to a full oxygen cylinder.
• NO OxYGEN is delivered in between settings.
• To avoid injury to patient:
• ALWAYS confirm prescribed setting before administering to patient and monitor flow on a frequent basis.
WARNING
• Use only Precision medical, Inc. Carry Bag designed for the
EasyPulse
5
to prevent an oxygen enriched environment.
• dO NOT place the unit under clothing while in use.
• When the Conserver is in use a small amount of oxygen is vented. Wearing the unit under clothing may saturate fabrics with oxygen and cause them to burn rapidly if exposed to sparks or flame. It may take several hours for oxygen levels in fabrics to return to normal.
• ALWAYS insert cylinder and the Conserver into bag, cylinder first with gauge facing mesh. Reference Accessory photo, (pg. 13).
10
MAINTENANCE / CLEANING
1. Disconnect all connections before cleaning.
2. After each use, clean exterior of the Conserver with a cloth dampened with mild detergent and water.
3. Wipe dry with a clean cloth.
4. Store the Conserver in a clean area free from grease, oil, and other sources of contamination.
CAUTION
• dO NOT use cleaning solutions.
• dO NOT immerse the Conserver in any kind of liquid.
• dO NOT attempt to repair the EasyPulse5 Oxygen Conserving
Regulator.
• All repairs must be performed by Precision medical, Inc.
RETURNS
Returned products require a Returned Goods Authorization (RGA) number, contact Precision medical, Inc. All returns must be packaged in sealed containers to prevent damage. Precision medical, Inc. will not be responsible for goods damaged in transit. Refer to Precision medical,
Inc. Return Policy available on the Internet, www.precisionmedical.com.
Manuals available on our Website; www.precisionmedical.com
dISPOSAL INSTRUCTIONS
This device and its packaging contain no hazardous materials. No special precautions need to be taken when disposing the device and/ or its packaging.
Please Recycle
11
TROUBLESHOOTING
If the Conserver fails to function, consult the Troubleshooting Guide below. If problem cannot be solved, consult your Provider.
TROUBLESHOOTING GUIdE
Problem
A. No flow
Probable Cause
1. Cylinder valve closed
2. Regulator in “OFF” position
3. Cylinder empty
4. Dial set between settings
5. Conserver not sensing breath
Remedy
1. Turn on cylinder
2. Set to prescribed setting
3. Replace cylinder
4. Set dial so indicator points to a setting
5. a. Check position of cannula in nose b. Do not breathe through mouth
1. Replace Inlet Seal
B. Leaking at cylinder connection
1. missing or defective
Inlet Seal
2. Defective cylinder valve
2. Contact your
Equipment Provider
REPLACEMENT PARTS
dESCRIPTION
Cannula
Inlet Seals (Viton O-rings)
For models: 195405 Serial # 100461or higher
195405NG Serial # 178367 or higher
For models: 19SE05 & 19SE05NG,
19DE05 & 19DE05NG
19GB05 & 19GB05NG
For models: 19ES05 & 19ES05NG
PART #
504833
505487
505214
505401
505214
505574
12
ACCESSORIES dESCRIPTION
Carry Bag m6
Carry Bag m4/m6
Carry Bag mL6/m9
PART #
503920
504184
504185 model 195405 Shown model 195405NG Shown
Carry Bag with shoulder strap
Conserver properly installed in Carry Bag
Conserver properly installed in Carry Bag
13
LIMITEd WARRANTY
ANd LIMITATION OF LIABILITY
Precision Medical, Inc. warrants that the EasyPulse5 Oxygen Conserving
Regulator (the Product) will be free of defects in workmanship and/or material for the following periods:
Two (2) years from date of shipment.
Should any failure to conform to this warranty appear within the applicable period,
Precision Medical, Inc. shall, upon written notification thereof and substantiation that the goods have been stored, installed, maintained and operated in accordance with Precision Medical, Inc.’s instructions and standard industry practice, and that no modifications, substitutions, or alterations have been made to the goods, correct such defect by suitable repair or replacement at its own expense.
ORAL STATEMENTS DO NOT CONSTITUTE WARRANTIES.
The representative of Precision Medical, Inc. or any retailers are not authorized to make oral warranties about the merchandise described in this contract, and any such statements shall not be relied upon and are not part of the contract for sale. Thus, this writing is a final, complete and exclusive statement of the terms of that contract.
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ANY WARRANTY OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR OTHER
WARRANTY OF QUALITY, WHETHER EXPRESS OR IMPLIED.
Precision Medical, Inc. shall not under any circumstances be liable for special, incidental or consequential damages including but not limited to lost profits, lost sales, or injury to person or property. Correction of non-conformities as provided above shall constitute fulfillment of all liabilities of Precision Medical, Inc. whether based on contract, negligence, strict tort or otherwise. Precision Medical, Inc. reserves the right to discontinue manufacture of any product or change product materials, designs, or specifications without notice.
Precision Medical, Inc. reserves the right to correct clerical or typographical errors without penalty.
14
dECLARATION OF CONFORMITY
Precision medical, Inc.
300 Held Drive
Northampton, PA 18067, USA
Emergo Europe (European Office) molenstraat 15
2513 BH, The Hague
The Netherlands
Phone: +31 (0) 70.345.8570
0473
Fax: +31 (0) 70.346.7299
EasyPulse5 Oxygen Conserving Regulator
198705EN, 195405, 19DE05, 19ES05, 19ES05-EN,19GB05, 19SE05,
19SE05-ES, 198705NG, 195405NG, 19ES05NG, 19ES05NG-EN,
19GB05NG, 19SE05NG, 19SE05NG-NO, 19Wm0501
Classification: IIb
Classification criteria: Clause 3.2 Rule 11 of Annex Ix of mDD
We hereby declare that an examination of the under mentioned production quality assurance system has been carried out following the requirements of the UK national legislation to which the undersigned is subjected, transposing Annex
II, 3 of the Directive 93/42/EEC and Directive 2007/47/EC on medical devices.
We certify that the production quality system conforms to the relevant provisions of the aforementioned legislation, and the result entitles the organization to use the CE 0473 marking on those products listed above.
Applied Standards: BS 341-3, DIN 477-1, EN 837-1, EN 1041, EN ISO 14971,
EN ISO 15001, ISO 228-1, ISO 10524-1, ISO 10524-3,
ISO 15223-1, ISO 18779, SS 367615
Notified Body:
Address:
AmTAC Certification Services Limited 0473
Davy Avenue Knowlhill milton Keynes mK5 8NL, UK
Certification Registration No’s: 1126 CE Date of Expiry: 03 August 2017
devices already manufactured: S/N traceability Device History Records
Validity of dOC: 04 August 2012 to Date of Expiry
Manufacture Representative: Quality manager
Position: Quality Systems/ISO Representative
date of Issue: 04 August 2012
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504429 Rev11 09/19/12 (?m) Printed in USA
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