USER MANUAL - Precision Medical
Contents
1. 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 when administering Oxygen therapy on pulse settings DO NOT use pulse settings while patient is sleeping unless continuous pulse oximetry is utilized DO NOT smoke in an area where oxygen is being administered The EasyPulseFlow is designed to operate with a single lumen adult cannula with a maximum length of 7 foot 2 1 m Flowmeter must meet specified inlet pressure range see SPECIFICATIONS To use Pulse Flow Control Knob must be set to 5 Ipm or greater ACAUTION Only personnel instructed and trained in its use should operate the EasyPulseFlow The EasyPulseFlow contains magnetic ferrous material that may affect the results of an MRI DO NOT autoclave DO NOT gas sterilize with EtO Ethylene Oxide DO NOT clean with aromatic hydrocarbons Avoid dropping the EasyPulseFlow or placing it in a position where it could fall and become damaged The EasyPulseFlow may not be able to detect all respiratory efforts of the patient Shallow breathers may not be able to trigger the EasyPulseFlow Operating the EasyPulseFlow outside its range of operating conditions may affect its accuracy and performance PRINCIPLES OF OPERATION The Precision Medical Inc EasyPulseFlow is a combination of two 2 devices atraditional Thorpe tube flowme2. 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 DECLARATION OF CONFORMITY Manufacturer Precision Medical Inc 300 Held Drive Northampton PA 18067 USA CONTACT Quality Manager Phone 610 262 6090 Authorized European Representative Emergo Europe European Office Molenstraat 15 2513 BH The Hague The Netherlands Phone 31 0 70 345 8570 Fax 31 0 70 346 7299 Product EasyPulseFlow Model s 19MFA Series MDD Class Ilb Classification criteria Clause 3 2 Rule 11 of Annex IX of MDD As delivered the object of the declaration described above is in conformity with the requirements of MDD 93 42 EEC Annex II 3 Directive 2007 47 EC of the European Parliament and the following documents EN 980 EN 1041 ISO 14971 ISO 15001 ISO 15002 ISO 18779 Notified Body TUV Rheinland Products Safety GmbH C 0197 EC
3. setting e g if patient is on 21 2 lpm place patient on pulse setting of 3 iii Instruct patient that oxygen will only flow during the first part of inspiration iv Assess patient conserver interaction to assure pulsing is occurring D Re assess patient s oxygenation status via pulse oximetry or arterial blood gas 8 Amount of oxygen may be weaned either by decreasing the continuous flow rate on the Thorpe tube flowmeter if patient is on continuous flow or by decreasing the pulse of oxygen if on pulse mode If patient is on pulse mode oxygen may only be decreased in increments of one 1 9 To turn off flowmeter turn the Flow Control Knob fully clockwise NOTE If nasal cannula is disconnected while on pulse oxygen therapy The device should not pulse oxygen into the atmosphere Limit of 3 pulses per minute MAINTENANCE CLEANING 1 Disconnect all connections before cleaning As needed 2 Clean exterior surfaces of the EasyPulseFlow with a cloth dampened with mild detergent and water 3 Wipe dry with a clean cloth 4 Store the EasyPulseFlow in a clean area free of grease oil and other sources of contamination CAUTION e DO NOT use cleaning solutions e DO NOT immerse the EasyPulseFlow in any kind of liquid e DO NOT attempt to repair the EasyPulseFlow e All repairs must be performed by Precision Medical Inc or Authorized Representative RETURNS Returned products require a Returned Goods Authorizat
4. Certificate No HD 60019110 0001 506340 Revi 061411 Printen In USA
5. Flowmeter set below e Increase flow 5 Ipm saturated in 5 lpm in pulse mode pulse mode Device not sensing e Change to continuous patient breath flow therapy LIMITED WARRANTY AND LIMITATION OF LIABILITY Precision Medical Inc warrants that the EasyPulseFlow 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
6. USER MANUAL EASYPULSEFLOW Conserver Howmeter Models 19MFA Series 19MFA1001 Shown SAVE THESE INSTRUCTIONS Federal USA law restricts this device to sale ACAUTION by or on the order of a physician PRECISION MEDICAL 300 Held Drive Tel 001 610 262 6090 Northampton PA 18067 USA Fax 001 610 262 6080 www precisionmedical com RECEIVING INSPECTION Remove the Precision Medical Inc EasyPulseFlow from the packaging and inspect for damage If there is any damage DO NOT USE and contact your Provider INTENDED USE The EasyPulseFlow flowmeter is intended for use by physicians respiratory therapists and other hospital personnel to administer selected doses of medical oxygen to patients suffering from hypoxia due to various etiologies and disease processes The device delivers via nasal cannula a Frio of 100 oxygen at all settings when connected directly to 100 gas source It is intended to be used as a device to provide continuous flow oxygen therapy or as an oxygen saving device that delivers pulsed volumes for oxygen therapy while reducing the drying of the patient airways READ ALL INSTRUCTIONS BEFORE USING This manual instructs a user to install and operate the EasyPulseFlow This is provided for your safety and to prevent damage to the EasyPulseFlow If you do not understand this manual DO NOT USE the EasyPulseFlow and contact your Provider ADANGER This product is not intended as a life susta
7. be 3 Turn Selector Dial to align indicator pointer with Continuous Flow setting 4 Turn Flow Control Knob to a Thorpe obtain appropriate flow rate Tube A To increase turn knob counterclockwise Flow Control B To decrease turn knob Oxygen clockwise Inlet C Set flow by aligning center of Float Ball with indicator lines on flow tube Selector Dial D To obtain maximum Increments Label flush flow turn knob fully counterclockwise Oxygen NOTE Flush flow is any pune flow above the last calibrated line on the Thorpe Flow Tube with an unrestricted flow as per SPECIFICATIONS Knob Indicator Pointer Label Product Serial Warning Label 5 Connect oxygen administration equipment via DISS connector on bottom of flowmeter 6 Assess effectiveness of oxygen therapy to the patient with pulse oximetry or arterial blood gas 7 If patient is stabilized on nasal cannula at lt 5 Ipm switch to pulse dose mode as follows A Remove any type of humidity bottle B Turn Flow Control Knob to obtain a flow of 5 lpm or greater C Select pulse setting from 1 to 5 by turning the Selector Dial to align Indicator Pointer with pulse setting NOTE DO NOT adjust Flow control knob on flowmeter i Choose pulse setting equal to continuous flow setting e g if patient is on 4 lpm continuous flow choose a pulse setting of 4 ii If patient is on a liter increment choose the next closest higher pulse
8. ining or life supporting device EXPLANATION OF ABBREVIATIONS Fio Fractional Concentration of Inspired Oxygen DISS Diameter Indexed Safety System psi Pounds Per Square Inch lpm Liters Per Minute bpm Breathes Per Minute SAFETY INFORMATION WARNINGS AND CAUTIONS ADANGER AWARNING ACAUTION CAUTION A ae S 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 CONSULT ACCOMPANYING DOCUMENTS Symbol for USE NO OIL 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 AWARNING e ALWAYS confirm prescribed dose before administering to patient and monitor on a frequent basis e Always follow ANSI and CGA standards for Medical Gas Products and Oxygen Handling G 4 e NO OXYGEN is delivered when the pointer W is between settings AWARNING The EasyPulseFlow is not to be used in the Pulse mode by patients who breathe through their mouths
9. ion 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 ws TROUBLESHOOTING If the EasyPulseFlow fails to function consult the Troubleshooting Guide below If problem cannot be solved consult your Provider Problem Probable Cause Remedy No flow e Flowmeter not securely e Securely attach pulse attached to oxygen flowmeter to oxygen outlet outlet e Thorpe tube flowmeter Turn ON the Thorpe not turned ON tube flowmeter using Flow Control Knob e Selector Dial set e Position Selector Dial between settings at correct setting Conserver e Selector Dial set e Position Selector Dial not sensing between settings at correct setting breath e Cannula disconnected e Connect cannula e Nasal cannula kinked e Replace cannula e Humidity bottle in line e Remove humidity bottle e Cannula greater than e ONLY use a7 ft or 7 ft long less cannula e High flow cannula not e Replace cannula with being used a high flow cannula Patient de e
10. o 5 7 1 4 Trigger Method Negative inspiratory effort from patient inhalation Breathing Frequency Up to 35 bpm Cannula Requirement Maximum 7 foot 2 1 m long standard adult single lumen nasal cannula The effect on accuracy of flow due to variations in ambient temperature is standard accuracy 7 3 32 F 0 C and 3 0 104 F 40 C The above flowmeter models are calibrated at specified inlet pressures as stated on Flowtube 70 F 21 C standard atmospheric pressure 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 COMPONENT DESCRIPTION ACAUTION Missing or illegible labels must be replaced contact Precision Medical Inc Reference photo on next page OPERATING INSTRUCTIONS AWARNING Read this User Manual before installing or operating the EasyPulseFlow CAUTION Inspect the EasyPulseFlow for visual damage before use DO NOT USE if damaged ACAUTION e DO NOT use pediatric low flow nasal cannulas or oxygen masks with the EasyPulseFlow e DO NOT block the cannula connection or kink cannula tubing when the Conserver is in use this may damage the EasyPulseFlow PEN y j OR Verify order need for oxygen administration 2 Connect flowmeter to oxygen gas source as stated on Flowtu
11. ter and a pulse oxygen conserver The EasyPulseFlow is designed to be used with low pressure oxygen systems at specified Inlet Pressure It consists of a back pressure compensated Thorpe tube flowmeter aconserving module and aselector dial to choose between Continuous Flow mode or Pulse mode Inthe Continuous Flow mode the flowmeter operates similar to a traditional Thorpe tube flowmeter the flow is determined by setting the flow control knob to the prescribed flow In this mode itis capable of delivering metered flows from 0 to 15 Ipm and up to 24 Ipm at flush flow In the Pulse mode the device operates as an oxygen conserver Settings of 1 through 5 are available and supply a similar Fro to the patient as continuous flow The conserving 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 oxygen is supplied to the patient through the nasal cannula SPECIFICATIONS Inlet Pressure Range 19MFA 50 psi 3 4 bar 19MFA AU 4 bar 58 0 psi 19MFA CI 5 bar 72 5 psi Pulse Settings 1 2 3 4and5 similar Fro to continuous flow value Continuous Flow Range 0 15 lpm metered 20 24 lpm max flush flow Pulse Accuracy Within 15 of the nominal bolus value at each breath rate Continuous Flow Accuracy 0 25 lpm from 0 5 lpm up to 5 Ipm 0 5 Ipm from 5 Ipm up to 15 Ipm Savings Ratio Up t
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