Silicone Resuscitator Directions for Use rev E

LSR dfu En 4492 E

07-07-06

11:18

Page 2

Indications for Use

Function Testing

To use the Laerdal Head Strap For Laerdal Child Mask 3-4 and Laerdal Adult Mask 4-5+, place the correct size Multi/Function Mask Cover over the mask connector. Fasten end of strap into the hooks on the cover. Tighten just enough to provide an airtight seal between mask and face.

The Laerdal Silicone Resuscitator is a self-inflating manual resuscitator that is intended for patients requiring total or intermittent ventilatory support.The Laerdal Silicone Resuscitator provides positive pressure ventilation and allows spontaneous breathing either with a 22 mm ID (inner diameter) facemask port, through an artificial airway or with a facemask that has a 15 mm OD (outer diameter) connection. The Preterm model is intended for patients below 2,5 kg (5,5 lb), the Paediatric model is intended for patients from 2,5 (5,5 lb) to 25 kg (55 lb), and the Adult model is intended for patients over 25 kg (55 lb).

CAUTION: Leave connectors in the necks of Ventilation Bags, Extension Tube, and Reservoir Bags during the entire decontamination procedure. Laerdal strongly discourages the use of rinsing and drying agents. Such agents may not be compatible with the materials used in the Laerdal Silicone Resuscitator.

For the Infant Mask 2, use the Attachment Ring supplied with the Laerdal Head Strap.

complete the test procedures described below:

The use of non-validated cleaning, disinfecting or sterilisation methods may have adverse effects on the LSR material and/or performance.

Ventilation with ambient air Resuscitator ventilation without supplemental oxygen is possible.

1. Intake/Reservoir Valve

Chose either the manual (I) or automatic (II & III) method below for cleaning the product.

a) Compress the ventilation bag with one hand and close its neck opening with your other hand.

I. Ventilation with oxygen The Laerdal Silicone Resuscitator can be connected to an O2 source via the oxygen nipple. Concentrations delivered to the patient depend on O2 flow rate, use (or non-use) of a Reservoir Bag and ventilation technique, e.g. tidal volume, ventilation frequency, time relations during compression-release cycles. See Technical Specifications.

Expiration Diverter An Expiration Diverter with two silicone gaskets can be snapped onto the Patient Valve. The diverter provides an airtight seal to the valve housing but does not prevent the swivel function (possibility of horizontally rotating the bag without interfering with the position of mask or tube) of the valve connector. The diverter will provide an airtight seal when expired air is free flowing.The use of the Expiration Diverter with a restriction device (e.g. PEEP Valve) may cause some air leakage around the silicone gasket of the Expiration Diverter. Equipment for measuring, scavenging or monitoring expired gases, can be attached to the standard (30 mm OD) outlet port of the diverter.

O2

Inhalation of supplemental oxygen A patient who breathes spontaneously can inhale O2 through the resuscitator with minimal resistance. Attachment of the reservoir increases O2 concentration. See Technical Specifications. The mask can be hand held or strapped to the face.

Practical Operation

When higher airway pressures are necessary, the operator can keep the Pressure Relief Valve closed with the tip of index finger while squeezing the bag.

a) When used in accordance with ISO 10651-4 the following resuscitator size recommendation applies: Adult for patients over 20 kg (44 lb), Paediatric for patients from 2.5 (5,5 lb) to 20 kg (44 lb) and Preterm for patients below 2,5 kg (5,5 lb).

A Lock Clip (optional) can be used as an alternative to finger pressure.

air out between your hand and neck of the bag, the valve efficiently prevents backward leakage of air.

a) Assure that a (single) Lip Valve has been installed

CAUTION:Thorough cleaning and rinsing are the first and most important steps in the reprocessing of any reusable medical device. Without thorough cleaning and rinsing, it might not be possible to achieve high-level disinfection or sterilisation of the device.

in the Patient Valve. Attach the Patient Valve to the bag. Hold a Reservoir Bag over the patient

1. The cycle has been validated on a Getinge Model A8666 validated to HTM2030. Ninhydrin protein detection test was used to qualify the process (to determine if any soil remained on the parts). Use of alternative washer/disinfector must be validated. 2. Includes pre rinse, main wash, rinse, final rinse and drying. 3. The Washing Detergent used in the validation – Olympic Chemicals Sprayclean 2000 (Non-enzymatic alkaline detergent containing 2-5% NaOH). Alternative detergents must be validated to show cleaning efficacy and material compatibility. Method has been validated using a common available tenside based Dish Washing Detergent (Zalo Ultra manufactured by Lilleborg AS). A pH neutral detergent solutions or hydrogen peroxide-based formulations may also be used for manual cleaning but must be validated to show they effectively clean the components.. 4. CAUTION: If detergent or disinfectant residuals are allowed to dry on the resuscitator parts, surfaces may become sticky, which may cause valve malfunction 5. Drying; the most effective method of drying is a fan assisted hot air cabinet, 50-70°C (122-158ºF) for at least 30 minutes. Other drying methods may be used but must be validated to show they effectively dry the components. The Reservoir Bag must be dried by blowing air into the Reservoir Bag opening. 6. The cycle has been validated on a Pasteurmatic Compact from Olympic Medical.

port connector pressing with your thumb on the

2. Disinfection/Sterilisation To obtain high-level disinfection/sterilisation of the resuscitator, the following 5 methods (I to V) have been validated and are recommended. The sterilisation methods apply to all parts except reservoir bags, Head Straps, Wall Bracket, Storage Pouch and Containers. High-level disinfection methods apply to all parts. Pasteurization applies to all parts except Wall Bracket, Storage Pouch and Containers

directs air to the patient.

Method

Process parameters Parameters/Concentration

reservoir bag connector. Ensure tight seal between the patient port and Reservoir Bag. Compress the bag with your other hand several times. Inspect that the Lip Valve opens during compression. Filling of the Reservoir Bag in this set-up confirms that the Patient Valve efficiently

b) With the filled Reservoir Bag held firmly to the valve connector, compress the Reservoir Bag while watching the external Disk Membrane. Lifting of the Disk Membrane from its seat

Post-treatment

confirms that air is correctly directed to

Exposure time

atmosphere instead of being returned to the

Sterilisation I. Steam Autoclaving (gravity- displacement)

Autoclave at 132-137ºC (270 - 279˚F)

15min. 00s (+ 30s)

II. Steam Autoclaving (prevacuum - pulse)

Autoclave at 134-137ºC (273-279ºF)

3min. 00s (+ 30s)

Conc.: 0,55% Ambient temperature

60 minutes

ventilation bag.

Allow parts to cool and dry.

2.2Patient Valve with Pressure Relief Valve

High-level disinfection III. Cidex OPA (orthophtalaldehyde)

IV. Sodium Hypochlorite

Conc.: 0,5% Ambient temperature

20 minutes

V. Pasteurization

Pasteurization cycle 70-75ºC (158-167ºF)

30 minutes

d) Follow local guidelines for resuscitation. 0/1

reasonable force, or if bag compression forces the

2.1 Patient Valve

c) Ventilate the patient by rhythmically compressing the bag for inspiration, allowing ample time between inspirations for patient's passive exhalation and bag re-expansion.

a) 00

the bag. If the bag cannot be compressed with

III. Automatic Cleaning by Pasteurmatic Compact. 6 30 min wash cycle at 32-43ºC (90-110ºF)

b) Either connect the Patient Valve directly to the patient´s tube, or choose the appropriate size mask and attach it to the Patient Valve. Mask seal on difficult anatomies may be improved by using the Multi Function Mask Cover (Mask size 3-4 and 4-5+ only).

Masks The Laerdal Silicone Resuscitator can be combined with the following mask types and sizes: a) Circular Infant Masks 00, 0/1, 2 b) Laerdal Child Mask 3-4 and Laerdal Adult Mask 4-5+ For difficult facial anatomies the Multi-Function Mask Cover is used to assist in getting a better mask seal.

b) Close the neck opening and try to compress

II. Automatic Cleaning by Washer/Disinfector Place parts in wire baskets. Cycle1 : 90-95ºC (194-203ºF) for more than 12 seconds.Total process time: approx. 52 min. 2 Use a Non-enzymatic alkaline detergent containing 2-5% NaOH3.

When used to deliver tidal volumes as recommended by the AHA/ILCOR Guidelines 2000, the following applies. Adult for patients over 25 kg (5,5 lb), Paediatric for patients from 2,5 kg (5,5 lb) to 25 kg (55 lb) and Preterm for patients below 2,5 kg.

Accessories

confirms efficient air intake.

Rinse parts in a sink under cold running water from a tap. Submerge parts in warm tap water (30-40ºC / 86-104ºF) ensuring that all surfaces are in contact with the warm water for at least 2 minutes before exposure to detergent. C Immerse all parts in hot tap water (60-70ºC / 140-158ºF) containing a Dish Washing detergent 3. Thoroughly clean all surfaces using a brush as necessary. D Rinse all components free of detergent 4 in warm tap water (30-40ºC / 86-104ºF). Dry the components thoroughly 5 E Inspect all components to confirm that they are CLEAN and DRY.

Extension Tube The flexible Silicone Extension Tube may be used between ventilation bag and the Patient Valve. This extension tube makes it easier to ventilate when the patient is being transported. It also permits an operator to squeeze the bag against a bed, strecher or themselves.

Pressure Relief Valve The Preterm and Paediatric resuscitators feature a Patient Valve with a pressure limiting device mounted on the upper valve housing. If patient airway pressure exceeds 35 cm H2O, the device opens to reduce the risk of stomach distention and barotrauma. A hissing sound can be heard when the device opens.

Release the grip on the bag. Rapid bag reexpansion

Manual Cleaning

B

Manometer Connector If used insert the Manometer Connector between the Patient Valve and the mask or tube adapter. Attach a manometer via tubing to the connector nipple (OD 6 mm) to monitor both inspiratory and expiratory pressures.

O2

Safety when using oxygen 1. Build-up and transfer of high pressure to the patient is prevented since excess O2 is vented to atmosphere over the outlet membrane of the Intake Valve. 2. When O2 supply is insufficient, adequate ventilation volume is ensured by intake of ambient air over the intake membrane of the Intake Valve. 3. A Reservoir Bag that stays flat during the whole ventilation cycle is a visual indication that no, or little supplemental O2 is being provided.

All masks are transparent to enable the user to observe the patient's face and lip colour and the temporary fogging caused by exhalations.

Test valve functions to ensure proper operation of the resuscitator after each disassemblyreassembly. An O2 Reservoir Bag is needed to

Close patient port connector with your thumb

Remove traces of disinfectant by rinsing in warm tap water (30-40ºC / 86-104ºF) for minimum 2 minutes. Dry the components thoroughly

while compressing the bag several times.Visual and audible opening of the relief valve confirms its operation.

2 e) If the Patient Valve becomes contaminated with vomitus during ventilation, disconnect the resuscitator from the patient and clear the Patient Valve as follows.

b)

- Tap the Patient Valve with the patient port against your gloved hand to shake free any contaminant and squeeze the silicone bag to deliver several sharp breaths through the Patient Valve to expel the contaminant.

3. Reservoir Flap Valves Dry the components thoroughly

(located in the Intake Valve assembly.) a) Do as described and shown in 2.1a above in

3. Inspection Carefully inspect all parts for signs of wear or damage. Worn or damaged components must be discarded and replaced with new components.

order to fill the Reservoir Bag with ambient air. Attach reservoir to the Intake Valve and press on

- If contaminant does not clear; disassemble the Patient Valve and rinse.

Reservoir Bag. 4. Reassembly Reassemble resuscitator as shown in Parts/Assembly Illustration, in this Directions for Use.

4-5+ Caution: Visually inspect and test valve function to ensure proper operation of the Laerdal Silicone Resuscitator prior to patient use. Improper assembly of the flap valves, intake membrane, disk membrane and lip valve may affect performance. Misassembly of two lip valves may cause inadvertant EEP (End Expiratory Pressure) or prevent proper patient exhalation.

3-4

Mask connection The Patient Valve has a standard 15 (ID)/22(OD) mm patient port which connects to all standard masks or tube adapters.The Laerdal Masks 4-5+ and 3-4, plus the mask size 2, fit outside the patient valve connector. All other infant sizes fit inside, to reduce deadspace.

Compression of the Reservoir Bag and visual rise of the outlet Flap Valve confirms that the Reservoir Valve efficiently vents excessive gas to atmosphere.

Caution: Patient Valve reassembly Make sure that only one Lip Valve Cat.No. 54 01 03 is installed. If the valve housing does not tighten completely during reassembly, it may indicate that two lip valves have been mounted instead of one. Also, be sure not to mix the Disk Membrane for the Patient Valve with the Intake Membrane meant for the Intake Valve assembly.Test functions as described in Function Testing.

Decontamination Thorough decontamination of the resuscitator components and accessories is necessary after each use.To reduce risk of cross contamination, follow steps below. 1. Washing and Rinsing Washing and rinsing is always the first step in the decontamination process.

b) Do as described and shown in 2.1a above in Upper part of valve housing

order to fill a Reservoir Bag with ambient air. Attach reservoir to the Intake Valve. With the

Lip valve

Patient Valve in place and the reservoir Valve housing, patient side

attached to the Intake Valve, perform several compression-release cycles on the ventilation bag

Disk membrane

until the Reservoir Bag is flat and empty. Rapid reexpansion of the ventilation bag after flattening of the Reservoir Bag confirms that the

A Disassembly - Disassemble the LSR into individual parts as shown in the Parts Illustration in Directions for Use, to make surfaces accessible to cleaning - Separate Expiration Diverter (if used) into its three parts - Separate Patient Valve into its four main parts - For Preterm and Paediatric models, unscrew top of Pressure Relief Valve, but do not disassemble this part any further. - Separate Intake Reservoir Valve into its six parts

2

Reservoir Valve efficiently lets in ambient air. Intake Valve reassembly Reassembly as shown right.

3

4

5