NeoForce Group
NeoPIP Instructions for Use Rev 08a June 2011
Instructions for Use
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NeoPIP™ Resuscitation Unit Instructions for Use
Read this manual carefully before operating the unit After reading this manual, keep it readily available for reference
NeoForce Group Inc PN NF-102 Rev 08a June 2011
Table of Contents 1 Introduction…………………………………………………………..3 2 Intended Use…………………………………………………………3 3 Basic Instructions……………………………………………………3 4 Symbol Definition……………………………………………….…..3 5 Warnings and Cautions……………………………………… ……..4 6 Controls and Indications…………………………………………….7 7 Features and Specifications………………………………………….8 8 Installation…………………………………………………………..10 9 Setup………………………………………………………………..10 10 Pre-use Check……………………………………………………..11 11 Instructions for Resuscitation……………………………………..12 12 Cleaning and Servicing……………………………………………12 13 Troubleshooting…………………………………………………..13 14 Supplies………..……………………………………………….…14 15 Contact Us………………………………………………………..14 16 Warranty………………………………………………………….15
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Introduction
This manual deals with the specifications, operation and maintenance of the NeoForce NeoPIP™ Infant Resuscitator Unit. NeoForce is not responsible for any product issue arising from a user ignoring the instructions for operation and maintenance as described in this manual; or for any accident attributable to repair by someone other than an authorized service representative. Read this manual carefully and familiarize yourself thoroughly with its contents before operating the unit. Keep this manual where it is readily accessible for reference by end users. If any technical problems should arise, please contact your local NeoForce Sales or Service Representative at 215-672-6800. Additional copies of this manual are available on request. CAUTION – this product is shipped without being disinfected. Be sure to clean and disinfect the unit before using it for the first time after purchase. Disposable and used parts as well as other products past their useful lives should be disinfected or sterilized and disposed of as medical waste according to your institution’s policy and procedures. 2
Intended Use
The NeoPIP is intended to deliver oxygen or blended gas to a neonate while controlling peak inspiratory pressure (PIP). NeoPIP is intended to be used in conjunction with the NeoPIP® Patient Circuit which provides positive end expiratory pressure (PEEP) control. The NeoPIP device provides, as a safety measure, an adjustable maximum pressure relief (Pop-Off) valve. Indication for Use Statement: The NeoPIP is a manually operated, gas powered device intended for controlled and accurate resuscitation of neonates and infants in the clinical environment. 3
Basic Instructions
1 – Follow these instructions for the safe use of the device 2 – Inspect the unit on a routine basis to ensure optimal performance 3 – Never use the unit if it is damaged or malfunctions in any way. Remove the unit from service and contact your NeoForce service representative at 215-672-6800.
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Symbol Definition
Attention: Consult Accompanying Documents WARNING – identifies situations or actions that may affect patient or user safety. Disregarding a warning could result in patient or user injury. CAUTION – points out special procedures or precautions that personnel must follow to avoid equipment damage. NOTE – a statement that provides additional information intended to clarify points, procedures or instructions. 5
Warnings and Cautions
Warning - Please read and understand the instructions fully before using the NeoPIP and related accessories. The NeoPIP is intended to be used only by personnel who have been trained in infant resuscitation. Warning - It is the responsibility of the purchaser to ensure that all users of this device have been adequately trained in resuscitation techniques and guidelines. Warning - The NeoPIP should only be used after completing a pre-use check to ensure that correct pressures will be delivered to the patient. If the device fails to operate as intended during pre-use checks remove the device from use and contact your NeoForce representative for service. Warning: Release the T-Piece as soon as the breath is delivered. Extended occlusion of the T-Piece may prevent exhalation. Warning - Ensure that there are no sources of ignition present when the device is in use. Warning - NeoPIP may only be used with flow regulated medical gases. Ensure that the range of supply pressures is regulated to 50 psi. Warning - Recommended gas flow range is 6 – 15 L/min. DO NOT USE FLOW GREATER THAN 15 L/min. Warning - The Maximum Pressure and PIP Pressure maximum setpoint is 60 cm H2O. Therefore, pressures may only be set below 60 cm H2O. Pressure settings above 40 cmH2O only be done in exceptional circumstances by persons trained in infant resuscitation. Warning - Use only the NeoPIP patient circuit and T-Piece.
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Warning – Ensure all oxygen and air supplies are turned off and disconnected from the NeoPIP prior to cleaning of the device. Fire hazards are possible in oxygen enriched environments. Caution – US Federal Law restricts this device to sale on or by the order of a physician. Note – Ensure that the oxygen concentration is monitored using an oxygen analyzer or preset using oxygen / air flow rate graphs. Note – The Maximum Pressure Relief valve acts as an overall pressure limit. Pressure above 60 cm H2O cannot be achieved. Note – The Maximum Pressure and Peak Inspiratory Pressure valves are in the same circuit. The PIP valve is intended for frequent use to adjust and control the desired patient supply pressure. The Maximum Pressure valve is intended to ensure that in the event of a valve failure the maximum pressure set point is not exceeded. Note – The NeoPIP is intended to be used with a single-use patient circuits to minimize the potential for cross-contamination and eliminating the need for time-consuming and costly reprocessing.
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Controls and Indicators (see Figure 1)
A
Front Panel Item Pressure Manometer Gauge
Description Displays Maximum Pressure Relief value during setup procedure, displays Peak Inspiratory Pressure and Positive End Expiratory Pressure during setup, checkout and with each inspiratory/expiratory cycle. Adjustment of knob will allow changing the pop-off set point. A cover for the knob is provided. Peak Inspiratory Pressure. Adjustment knob will allow changing the PIP set point.
B
Maximum Pressure or Pop-Off Control
C
PIP Control
D
Gas Inlet
Tapered barbed fitting for attachment of oxygen hose.
E
Patient Circuit
Fitting to receive the standard 15 mm NeoPIP patient circuit connector.
(A) Pressure Manometer (B)Maximum Pressure Pop-off (C) Peak Inspiratory Pressure
(D) Gas Inlet Port
(E) Patient Circuit Connection
Figure 1
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Features and Specifications
The NeoPIP is intended for emergency manual resuscitation of neonates and infants. The device is used in conjunction with a flow meter to control the gas inlet and a blender if blended air and oxygen is desired. Breathing frequency is controlled by the caregiver’s rate of occlusion and release of the T-Piece port which directs the flow to and away from the patient. PIP – Peak Inspiratory Pressure can be set by the PIP Control knob over a range of 2 to 60 cm H2O as a function of flow rate. The value is displayed on the manometer. PEEP – Positive End Expiratory Pressure can be set over a range of 2 to 25 cm H2O as a function of flow rate. This is set by adjusting the knob on the top of the breathing circuit T-piece. The value is displayed on the manometer Maximum Pressure Relief – can be set by adjusting the control knob over a range of 2 to 60 cm H2O. The value is displayed on the manometer. Gas Inlet connections – medical gases (oxygen and air) can be provided by tank or by wall outlet. Gas from the source will pass through the blender, then flow meter and into the NeoPIP™ Gas Inlet. The gas inlet connection is a standard ¼ inch tapered barb fitting. Patient Circuit – the patient circuit is single patient use with a standard 15 mm ID x 22 mm OD fitting. The patient circuit is Latex and DEHP Free.
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Description
Specification
Maximum Pressure Relief.
Setting between 5 cm and 60 cm H2O/mbar, factory setting is 40 cm H2O/mbar at 6 L/min
Peak Inspiratory Pressure (PIP)
2 – 60 cm H2O at 6 L/min
Positive End Expiratory Pressure (PEEP)
At 6 L/min PEEP = 2 to 5 cm H20 At 8 L/min PEEP = 2 to 6 cm H2O At 10 L/min PEEP = 2 to 8 cm H2O
Dead Space
< 7 mL
Expiratory Resistance
< 5 cm H2O
Inspiratory Resistance
< 5 cm H2O
Height
26 cm (10.25 in)
Width
15.25 cm (6 in)
Depth
9 cm (3.5 in)
Weight
2.8 kg (6.2 lbs)
Mounting
IV pole, F-rail, wall mount, free standing with handle for transport
Manometer
-20 to 80 cm H2O +/- 2
Gas Inlet flow range (accessory flow meter)
1 L/min to 15 L/min
Oxygen Concentration (accessory blender)
21 – 100% based on gas supply
Operating Temperature
10 – 40 deg C
Operating Humidity
up to 90% RH non-condensing
Operating Altitude
0 – 10,000 ft
Storage /Transportation Temperature
-20 deg C to 60 deg C
Storage Humidity
up to 90% RH non-condensing
Immersion Resistant
Temporary Submersion will not affect functionality
Cleaning Recommendations
Clean with warm soapy water. For surface disinfection use Opti-Cide a quaternary ammonium solution
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Installation
NeoPIP is designed to mount to a pole when oriented horizontally, an MF Rail when oriented vertically, or wall using NeoPIP mounting bracket (NF-101). NeoPIP may also be used as a free standing device on a shelf. When NeoPIP is freestanding, ensure that the NeoPIP is removed prior to moving the incubator or warmer. When NeoPIP is freestanding with a transport, strap the NeoPIP to the monitor shelf with restraint straps. Once the desired location for the NeoPIP is determined setup may be initiated.
NF-100 NeoPIP NF-101 Bracket
Horizontal Orientation for Pole Mounting
Vertical Orientation for MF-Rail
When mounting the NeoPIP™ to Pole ensure that the pole is placed in the V portion of the clamp.
When mounting the NeoPIP to MF-Rail ensure that the rail is flush against the back of the bracket and fits into the rectangular cutout in the top of the bracket.
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Setup
The NeoPIP must be used in conjunction with a flowmeter with a range of 0 – 15 L/min. NeoPIP may be used with a blender if a range of oxygen concentration between 21% and 100% is desired. If a blender is used: First attach the air and oxygen gas sources to the appropriate blender ports. If the blender and flow meter are separate devices, then attach them according to manufacturer’s instructions. Attach the blender gas outlet to the inlet of the flow meter. If a blender is not used then attach the gas supply directly to the inlet of the flow meter. Attach standard medical gas tubing from the outlet of the flow meter to the GAS INLET tapered barb on the front of the NeoPIP. Connect the patient circuit to the patient circuit outlet on the front bottom right of the NeoPIP device. Connect a test lung to the patient circuit T-Piece if available or occlude the patient outlet with the palm of the hand. 10
Pre-Use Check
Adjust the gas supply to 6 L/min. The unit will come with the following preset values. The Maximum Pressure will be set to 40 cm H2O and the Peak Inspiratory Pressure (PIP) will be set to 20 cm H20. The values should be confirmed when the unit is first checked. To check/set Maximum Pressure: Occlude PEEP valve at the distal end of the patient circuit
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Turn the PIP control knob on the front of the device several turns clockwise.
Turn the Maximum Pressure control knob to set the desired maximum pressure pop-off.
To set the PIP While still occluding the PEEP valve, turn the PIP control knob counterclockwise to set the desired peak inspiratory pressure which is displayed on the manometer.
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To set the PEEP Release the PEEP valve and adjust to set the desired positive end expiratory pressure which is displayed on the manometer.
Turn off the gas supply and remove the test lung from the patient circuit T-Piece. If the device fails to operate as intended during pre-use checks remove the device from use and contact your NeoForce representative for service. 11
Instructions for Resuscitation
(1) Adjust gas supply to 6 LPM and set PIP and PEEP pressures, verify settings on manometer display. (2) Fit T-piece to neonatal resuscitation mask and place over the patient’s mouth and nose or fit patient T-piece to the endotracheal tube. (3) Resuscitate by placing and removing the thumb or index finger over the PEEP valve port at the top of the T-Piece to allow inspiration and expiration at the desired breath rate. 12
Cleaning and Servicing
The NeoPIP patient circuit is disposable. Discard according to local requirements for bio-hazardous waste. Clean the external surfaces of the NeoPIP with a damp cloth and mild soapy water. To disinfect, use Opti-Cide, a quaternary ammonium solution. Dry all surfaces after cleaning with a clean soft cloth or paper towel NeoPIP does not require service or maintenance under normal use conditions and when pre-use checks are conducted. If the device fails to operate as intended during pre-use checks remove the device from use and contact your NeoForce representative for service. Do not disassemble the NeoPIP device.
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Troubleshooting
Trouble
Possible Cause
No gas flow to the patient
Not connected to gas supply source Gas supply source is depleted Hose from gas supply is not connected to flow meter / blender Hose from flow meter to NeoPIP™ is not connected Patient circuit is not connected to NeoPIP Hose or patient circuit is kinked or occluded Maximum pressure valve or PIP control valve are fully closed
Insufficient gas flow to the patient
Leak in one of the connections
Pressure Gauge is erratic or jumpy
There is not a good seal at the T-Piece
Control knobs do not function Display does not function
Damage to knob or valve Damage to gauge
Action to take Connect hose to Wall or Tank gas supply source Replace tank Secure connection to flow meter / blender Secure connection between flow meter and NeoPIP™ Gas Inlet Secure patient circuit to NeoPIP™ Patient Circuit connector Unkink or replace kinked or occluded item. Open valves and perform check out procedure. If this does not resolve the problem, remove the unit from service.* Check and secure all hose connections, perform checkout. If this does not address leak, remove the unit from service.* During pre-use check ensure that T-Piece is fully occluded, during use on a patient ensure that there is a good seal at the patient mask or endotracheal tube. Remove the unit from service.* Remove the unit from service.*
*In all cases where the unit is removed from service, immediately contact NeoForce Group Service at 215-672-6800.
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Supplies
Part Number
Description
NF-103
7 ft Oxygen Tubing
NF-104
4 ft Oxygen Tubing
NF-150
NeoPIP® Single Patient Use Resuscitation Circuit (box of 20)
NF-160
Single Patient Use Round Face Mask, Size 0
NF-151
Single Patient Use Round Face Mask, Size 1
NF-101
NeoPIP Mounting Bracket
60862
V-505 Radiant Warmer IV pole
NF-031
V-505 Radiant Warmer Multi-purpose pole
60865
V-505 Radiant Warmer MF-Rail Adaptor
OSC12-024 OCW06-100
Opti-Cide Surface Disinfectant 24 oz bottles Opti-Cide Surface Wipes
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Contact Us
NeoForce Group Inc. 35 Commerce Drive Ivyland, Pa 18974 USA
Phone 215-672-6800 Fax 215-762-1123 www.neoforcegroup.com [email protected]
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Warranty
This equipment is guaranteed by NeoForce Group Inc. for a period of one year from the date of delivery to be free of any defects in both materials and workmanship when used normally for its intended purpose. Any parts of this equipment proving to be defective will be repaired or replaced at no charge during the warranty period. In the following cases, however, actual expenses need to be paid even during the warranty period:
Wear and tear of consumables Damage arising from improper handling, such as dropping the unit during transport or transfer. Issues arising from natural disasters such as fire, earthquake, flooding, etc.
Damage in shipment should be reported promptly to NeoForce accompanied by the certificate of the carrier concerned. All correspondence concerning the equipment should specify the model name and the serial number. Consumables are defined in the product specification section under Accessories. These items, disposable / single use items and replacement parts have a 90 day warranty.
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NeoForce Group Inc 35 Commerce Drive Ivyland, Pa 18974
Authorized Representative: Emergo Europe Molenstraat 15 2513 BH The Hague
www.neoforcegroup.com T (215) 672-6800 F (215) 672-1123
The Netherlands T (31) (0) 70 345-8570 F (31) (0) 70 346-7299
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NeoPIP Instructions for Use Rev 08a June 2011 PN NF-102
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