USER MANUAL - Precision Medical

USER MANUAL - Precision Medical

U S E R M A N U A L

Models: 19MFA Series

(19MFA1001 Shown)

CAUTION

SAVE THESE INSTRUCTIONS

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 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 F

IO

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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.

dANGER

This product is not intended as a life-sustaining or life-supporting device.

ExPLANATION OF ABBREVIATIONS

F

IO

2

DISS

Fractional Concentration of Inspired Oxygen

Diameter Indexed Safety System psi Pounds Per Square Inch lpm bpm

Liters Per Minute

Breathes Per Minute

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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.

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)

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).

• NO OXYGEN is delivered when the pointer is between settings.

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WARNING

• The EasyPulseFlow is not to be used in the Pulse mode by patients who breathe through their mouths.

• 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 lpm or greater.

CAUTION

• 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.

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PRINCIPLES OF OPERATION

The Precision Medical, Inc. EasyPulseFlow is a combination of two (2) devices, a traditional Thorpe tube flowmeter 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, a conserving module, and a selector dial to choose between Continuous Flow mode or Pulse mode.

In the 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 it is capable of delivering metered flows from 0 to 15 lpm and up to 24 lpm 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 F

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2

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:

Pulse Settings:

19MFA: 50 psi (3.4 bar)

19MFA AU: 4 bar (58.0 psi)

19MFA C

I

: 5 bar (72.5 psi)

1, 2, 3, 4 and 5

(similar F

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2

to continuous flow value)

Continuous Flow Range:

Pulse Accuracy:

0-15 lpm metered

(20-24 lpm max flush flow)

Within ±15% of the nominal bolus value (at each breath rate)

Continuous Flow Accuracy: ±0.25 lpm from 0.5 lpm up to 5 lpm

±0.5 lpm from 5 lpm up to 15 lpm

Savings Ratio:

Up to 5.7:1

4

Trigger Method:

Breathing Frequency:

Cannula Requirement:

Negative inspiratory effort from patient inhalation

Up to 35 bpm

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

CAUTION

Missing or illegible labels must be replaced, contact Precision

Medical, Inc.

Reference photo on next page.

OPERATING INSTRUCTIONS

WARNING

Read this User Manual before installing or operating the

EasyPulseFlow.

CAUTION

Inspect the EasyPulseFlow for visual damage before use,

DO NOT USE if damaged.

5

CAUTION

• dO NOT use pediatric, low flow nasal cannulas or oxygen masks with the EasyPulseFlow.

• dO NOT block the cannula connection or kink cannula tubing when the Conserver is in use, this may damage the EasyPulseFlow.

OR

1. Verify order/need for oxygen administration.

2. Connect flowmeter to oxygen gas source, as stated on Flowtube.

3. Turn Selector Dial to align indicator pointer with

Continuous Flow setting.

4. Turn Flow Control Knob to obtain appropriate flow rate.

Thorpe

Tube

A. To increase, turn knob

counterclockwise

B. To decrease, turn knob

clockwise

C. Set flow by aligning center of Float Ball with indicator lines on flow tube.

Oxygen

Inlet

Flow Control

Knob

D. To obtain maximum flush flow, turn knob fully counterclockwise.

Selector Dial /

Increments Label

Indicator

Pointer / Label

Product Serial #

/ Warning Label

NOTE: Flush flow is any

Oxygen

Outlet

flow above the last calibrated line on the Thorpe Flow

Tube with an unrestricted flow, as per “SPECIFICATIONS”.

6

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 ≤ 5 lpm, 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 ½ liter increment choose the next closest higher pulse setting (e.g. if patient is on 2½ 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 .

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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

• dO NOT use cleaning solutions.

• dO NOT immerse the EasyPulseFlow in any kind of liquid.

• dO NOT attempt to repair the EasyPulseFlow.

• All repairs must be performed by Precision Medical, Inc. or

Authorized Representative.

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

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TROUBLESHOOTING

If the EasyPulseFlow fails to function, consult the Troubleshooting

Guide below. If problem cannot be solved, consult your Provider.

Problem

No flow/ pulse

Conserver not sensing breath

Patient desaturated in pulse mode

Probable Cause

• Flowmeter not securely attached to oxygen outlet

• Thorpe tube flowmeter not turned ON

• Selector Dial set between settings

• Selector Dial set between settings

• Cannula disconnected

• Nasal cannula kinked

• Humidity bottle in line

• Cannula greater than

7 ft long

• High flow cannula not being used

• Flowmeter set below

5 lpm in pulse mode

• Device not sensing patient breath

Remedy

• Securely attach flowmeter to oxygen outlet

• Turn ON the Thorpe tube flowmeter using

Flow Control Knob

• Position Selector Dial at correct setting

• Position Selector Dial at correct setting

• Connect cannula

• Replace cannula

• Remove humidity bottle

• ONLY use a 7 ft or less cannula

• Replace cannula with a high flow cannula

• Increase flow ≥ 5 lpm

• Change to continuous flow therapy

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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.

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.

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Manufacturer:

dECLARATION OF CONFORMITY

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):

MDD Class:

Classification criteria:

19MFA Series

IIb

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: TÜV Rheinland Products Safety GmbH

EC Certificate No.: HD 60019110 0001

506340 Rev1 061411 P rinted in

USA

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