Atos Medical ProTrach DualCare Instructions For Use Manual

Instructions for Use

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Figure 1

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15 min

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Prescription information

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CAUTION: United States Federal law restricts this device to sale, distribution and use by or on order of a physician or a licensed practitioner. The availability of this product without prescription outside the United States may vary from country to countr y.

Disclaimer

Atos Medical offers no warranty – neither expressed nor implied – to the purchaser hereunder as to the lifetime of the product delivered, which may vary with individual use and biological conditions. Furthermore, Atos Medical offers no

warranty of merchantability or tness of the product for any

particular purpose.

Patent and trademarks

ProTr a ch® is a registered trademark and DualCare™ is a trademark of Atos Medical AB. The products are protected by US patent no. US 6,921,417, JP patent no. 4,156,832 as well as other patents.

Contents

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ENGLISH ..........................................................................9

DEUTSCH ..................................................................... 24

NEDERLANDS ............................................................. 41

FRANÇAIS .................................................................... 58

ITALIANO ...................................................................... 75

ESPAÑOL ...................................................................... 92

PORTUGUÊS ..............................................................109

SVENSKA .................................................................... 127

DANSK ......................................................................... 142

NORSK ......................................................................... 158

SUOMI ......................................................................... 173

ORDERING INFORMATION ..................................189

ENGLISH

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The Instructions for Use, which accompanies this product, may be revised from time to time and must therefore be reviewed prior to each procedure in which the product is used.

Contents

1. Descriptive information ............................................................10

1.1 Intended use ..........................................................................10

1.2 CONTRAINDICATIONS ........................................................10

1.3 Description of the devices ................................................11

1.4 WARNINGS ..............................................................................14

1.5 PRECAUTIONS .......................................................................16

2. Instructions for use .....................................................................17

2.1 Preparation and assembly of the speaking

devices ............................................................................................17

2.2 Insertion and usage of Speaking Valve

with HME 15 / 22 .........................................................................18

2.3 Insertion and usage of HME DigiTop and HME DigiTop O

2.4 Removal of the HME from the speaking devices......20

2.5 Pediatric Use ..........................................................................20

2.6 Cleaning and disinfection ................................................21

2.6.1 Cleaning of the speaking devices ..........................21

2.6.2 Disinfection of the speaking devices ....................22

2.7 Storage instructions ............................................................23

2.8 Device lifetime ......................................................................23

2.9 Disposal ...................................................................................23

2.10 Accessories ..........................................................................23

3. Additional information .............................................................23

3.1 Compatibility with MRI Examination ............................23

3.2 Ordering information .........................................................23

3.3 User assistance information .............................................23

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Symbol explanation

Keep away from direct sunlight and heat.

Keep dry and away from rain and other moisture.

1. Descriptive information

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1.1 Intended use

ProTrach DualCare is a combined Speaking Valve and Heat and Moisture Exchanger (HME) intended for spontaneously breathing tracheostomized patients using a tracheostomy

tube with a deated cuff, or a tracheostomy tube without cuff.

In HME-mode the device conditions inhaled air by retaining heat and moisture from the exhaled air. By turning the lid of the Speaking Valve into speaking mode air is re-directed to enable speech. The entire device is for single patient use and the HME-part is for single use.

Patient Population: For spontaneously breathing tracheostomized patients (adults and pediatric patients greater than 10 kg in

weight) using a tracheostomy tube with a deated cuff, or a

tracheostomy tube without cuff. Environment of Use: Hospitals, ICU, sub-acute care institutions

and home.

1.2 CONTRAINDICATIONS

General

ProTrach HME 15 or 22 in combination with either ProTrach DualCare Speaking Valve or ProTrach HME DigiTop are contraindicated for:

- Use in combination with an in-line ventilator.

- Patients who are unable to handle or remove the device themselves when needed, unless the patient is under constant supervision of a clinician or a trained caregiver. For example, patients who are unable to move their arms, patients with decreased levels of consciousness, or patients with diseases that put them at risk for unpredictable periodic loss of consciousness.

- Patients who cannot tolerate the added dead space of 5 ml, or who cannot tolerate the added breathing resistance of 170 Pa / 1.7 cm H clinician.

- Unresponsive or sedated patients. The patient must be responsive and attempting to communicate in order to use the device. The patient should be able to follow instructions.

O. This should be evaluated by a

The HME 15 or 22 in combination with either Speaking Valve

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or HME DigiTop must NOT be used on a single lumen tube (tube without an inner tube), unless the patient or caregiver is able to reinsert the tube themselves after emergency removal.

Speaking Valve specic

The use of S peak ing Valve (in combination with HME 15 or 22) is additionally contraindicated for the following patient groups:

- Laryngectomized patients since the device will prevent the

ability to exhale if the Speaking Valve is unintentionally set to speaking mode.

- Patients suffering from severe aspiration.

- Patients with severe obstruction in the area of the

tracheostomy tube or in the upper airways, such as tracheal and/or laryngeal stenosis, since this may cause air trapping.

- Patients with very thick and copious secretions which might

block the device.

DO NOT use the Speaking Valve:

- In combination with a tracheostomy tube with the cuff

inated. The cuff must be completely deated before

placing and during all use of the Speaking Valve.

- In combination with a tracheostomy tube with a foam cuff.

- In combination with a tracheostomy tube with a self-

inating cuff.

- When the size of the tracheostomy tube does not allow for

airow through the upper airways.

- In combination with an endotracheal tube.

Use of the Speaking Valve in these circumstances can restrict exhalation through the upper airways and cause suffocation!

DO NOT use the Speaking Valve during sleep since the airway

could be blocked unintentionally. During sleep the HME DigiTop (in combination with HME 15 or 22) should be used instead (Figure 2a or 2b).

1.3 Description of the devices

The Speaking Valve, the HME DigiTop, and the HME Dig iTop O2 are all used to enable speaking. In this Instructions for Use they will therefore be referenced to as “speaking devices”.

Speaking Valve and HME 15 / 22

The reusable Speaking Valve is used with a single use 15 mm or 22 mm Heat and Moisture Exchanger (HME). The HME is placed so that it prevents direct contact between the Speaking

Valve and the airways. This prevents the Speaking Valve from

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being clogged or soiled by mucus. The Speaking Valve has two modes: speaking mode and

HME mode.

In speaking mode, a exible membrane is positioned in

the airow openings and acts as a one way valve. It opens

during inhalation so the patient can inhale through the device. During exhalation, the membrane remains closed and the air is re-directed through the upper airways and the vocal folds. Thereby the patient is able to speak. In speaking mode the inhaled air does not get conditioned since the exhaled air goes out through the upper airways.

In HME mode the membrane is moved out of the way of the

ai r ow so that the patient both inhales and ex hales th rough the

device. The inhaled air is conditioned by the heat and moisture that is retained from the exhaled air in the impregnated HME media. In HME mode, speaking is not possible.

The device is switched between the modes by rotating the lid of the Speaking Valve until it clicks into the desired position.

The ProTrach HME 15 is available in two versions: the XtraMoist

with better humidication properties and the Regular with lower

breathing resistance. The XtraMoist should be used when the

slightly higher breathing resistance is tolerated. The Regular

should be used when lower breathing resistance is required,

for example when rst getting used to HME use or during

physical activity.

HME DigiTop and HME DigiTop O

The HME DigiTop and the HME DigiTop O2 enable use of the HME without the Speaking Valve, and can manually be occluded to enable speaking.

The HME DigiTop O2 provides possibility to connect oxygen tubing of 1/8 inch (3.2 mm) diameter to the Oxygen port connector for patients requiring additional Oxygen (Figure 16).

ProTrach DualCare Set 15 / Set 22 include:

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See Figure 3 (a) 1 pc ProTrach DualCare Speaking Valve

(b1 or b2) 30 pcs (b1) ProTrach HME 15 Regular or (b2) ProTrach HME 22 Regular

(f) 1 pc Removal Aid

1 pc ProTrach DualCare Instructions for Use

ProTrach DualCare Speaking Valve / Speaking Valve Blue package include:

See Figure 3 (a) 1 pc ProTrach DualCare Speaking Valve or Speaking Valve Blue (c) 1 pc ProTrach Connection Strap clip (d) 1 pc ProTrach Connection Strap string (e) 1 pc ProTrach HME DigiTop or DigiTop Blue 1 pc ProTrach DualCare Instructions for Use

Technical data ProTrach DualCare

Speaking Valve with HME 15 Speaking Valve with HME 22

Pressure drop at 30 l/min in

speaking mode, HME 15 Regular:

Pressure drop at 30 l/min in HME

mode, HME 15 Regular:

Pressure drop at 60 l/min in HME

mode, HME 15 Regular:

Pressure drop at 30 l/min

in speaking mode, HME 15

XtraMoist:

Pressure drop at 30 l/min in HME

mode, HME 15 XtraMoist:

Pressure drop at 60 l/min in HME

mode, HME 15 XtraMoist:

Dead space:

(Speaking Valve incl HME)

* During increased physical activity that requires lower breathing resistance the Regular HME

is recommended. Therefore, the XtraMoist is not tested in these conditions.

Oxygen concentration measured at:

Tidal volume 1 L, breathing frequency 10/min, O

DigiTop O2 with HME 15 70%

DigiTop O

with HME 22 71%

Pressure drop at 30 l/min in

125 Pa

speaking mode:

Pressure drop at 30 l/min in

35 Pa

HME mode:

Pressure drop at 60 l/min in

123 Pa

HME mode:

166 Pa

78 Pa

Dead space:

4.05 ml (Speaking Valve incl HME)

136 Pa

48 Pa

166 Pa

4.62 ml

ow 10 L/min

1.4 WARNINGS

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Speaking Valve specic

(Speaking Valve in combination with HME 15 or 22).

WARNING

If a tracheostomy tube with a cuff is used, the cuff must be completely deated before placing, and during all use of the Speaking Valve. The patient cannot breathe if the

cuff is not completely deated. There should be sufcient airow around the tracheostomy tube and the deated cuff.

DO NOT use the Speaking Valve for patients who use a

tracheostomy tube with a self-inating or foam-lled cuff.

Use of Warning Labels: Attach warning labels provided with Speaking Valve to the tracheostomy tube pilot balloon

ination line (Figure 1).

Monitoring: Patients with a tracheostomy tube with a cuff using the Speaking Valve must be monitored according to physician direction. Continuous observation is needed to make sure that the patient can exhale through the upper airway.

Education: To ensure correct use of the Speaking Valve, the patient, family, caregivers, and all personnel working with the patient must be instructed on how to use Speaking Valve, including contraindications, warnings, warning labels and precautions.

- Do make sure the patient has the respiratory ability to exhale around the tracheostomy tube and out of the nasal and oral cavities.

- Do make sure the patient has been cleared by the physician

for cuff deation. Cuff deation is mandatory with the

Speaking Valve to allow exhaled air to pass around the tracheostomy tube and upper airways.

- Do make sure the tracheostomy tube is sized to allow

for sufcient airow around the tracheostomy tube to

facilitate speech. The cuff on the tube can also generate an

obstruction even when deated and this should be taken

into consideration during airway patency assessment.

- Do evaluate, per physician direction, if changing to a

smaller tracheostomy tube is indicated to provide sufcient airow to allow use of the Speaking Valve.

- Do evaluate patients with thick unmanageable secretions

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that may cause airway obstructions for use of the Speaking Valve.

- Do evaluate patient experiencing difculty utilizing the

Speaking Valve, as the patient may have airway obstructions due to stenosis, tissue mass, tracheomalacia, granulation, vocal cord paralysis in the midline position, secretions, or a tracheostomy tube that is oversized for the patient’s trachea. If obstruction is corrected, the patient should be re-evaluated for the Speaking Valve.

General

(HME 15 and 22 in combination with either Speaking Valve or HME DigiTop).

- Do make sure that patients with severe pulmonary diseases,

e.g. lung emphysema, severe asthma etc. are examined and evaluated by a clinician to ensure suitability before they start using the device.

- Do make sure that the patient or caregiver always has the

ability to remove the device quickly from the tracheostomy tube if needed. Coughing up a lot of mucus may suddenly block or nearly block the tube or HME.

- Do make sure that the patient, caregiver and others

understand the closing function and the use of the holes. Do explain that blocking the holes in the Speaking Valve or the HME DigiTop by clothing, for example, may cause

difculty in breathing or suffocation.

Do not

- Do not bathe or swim with the device (Figure 4a or 4b).

This could cause water to enter the airways. The speaking devices do not prevent this in any mode.

- Do not use the device if it has been damaged or contaminated.

- Do not remove the foam from the HME. Using the

device without the foam increases the risk of aspiration of small device parts, it may also negatively impact valve functionality due to direct mucus contact, and also without the foam the important HME function is lost.

- Do not reuse the HME, e.g. by washing it. By washing the

HME the important HME function is lost. Reuse can also

increase the risk of infection.

- Do not use any part of the device for more than one patient

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since this may cause cross contamination. The device is intended for single patient use only.

HME 22 specic

(HME 22 in combination with either Speaking Valve or HME Dig iTop).

- If the Speaking Valve comes loose from the HME 22 during the removal of the device, always remove the inner tracheostomy tube or the single lumen tube together with the HME instead of trying to remove the HME from the tube connector.

Attempts to remove the HME 22 from the connector

while the tube is still in place is difcult, and the airways

may become blocked by mucus.

1.5 PRECAUTIONS

- Do always check before each use that the Speaking Valve rotates properly between the two modes. The Speaking Valve may get stuck in one of the modes due to the presence of mucus. If this occurs, clean the device thoroughly and if the problem persists stop using the device and replace it.

- Do check the device if you experience increased breathing resistance as this might be a sign of blockage by (e.g., by mucus).

- Do consult your clinician if there is a problem in connection with the device.

Do not

- Do not use humidiers or heated humidied oxygen via a

mask over the tracheostoma while using the device since it will cause the HME to become too wet. If oxygen therapy

is required, use only non-heated humidied oxygen.

- Do not administer medicated nebulizer treatment over the tracheostoma while using the device. The medication can become deposited in the HME and medications may also adversely affect the Speaking Valve membrane. If the device is inadvertently used during a medicated nebulizer treatment, the device must be removed immediately. The HME must be discarded, and the Speaking Valve and the

HME DigiTop must be cleaned thoroughly to remove all

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medication residues.

2. Instructions for use

The speaking devices (Speaking Valve, HME DigiTop and HME Dig iTop O2) are reusable. The HME cassettes are disposable and must be exchanged at least every 24 hours.

2.1 Preparation and assembly of the speaking devices

CAUTION: Use only original accessories with the device. Use of other accessories may cause product malfunction and harm the patient.

When the Speaking Valve in combination with a HME is not advisable, evaluate the possibility of using the ProTrach HME DigiTop in combination with a HME.

Before each use, please check that the speaking device (Speaking Valve, HME DigiTop, or HME DigiTop O2) and HME are undamaged and that the Speaking Valve functions as intended, e.g., it clicks into the HME mode and speaking mode. If the device does not function as intended or seems damaged, do not use the device and replace it.

Attach the ProTrach Connection Strap

The ProTrach Connection Strap can be used to secure the Speaking Valve to the neckband (optional). This is done to avoid that the device is lost, for example, when coughing or sneezing.

1. Insert the string of the Connection Strap into the clip

(Figure 5a and 5b).

2. Insert the string of the Connection Strap to the Speaking

Valve (Figure 5c).

Note: If the Connection Strap is pulled with a certain force, the string will loosen from the clip. This is a security feature to prevent injury if the string accidentally is caught up somewhere. If this occurs, just insert the string again in the clip (Figure 5a and 5b).

CAUTION: Do not attempt to glue or otherwise permanently attach the string to the clip or Speaking Valve.

Assemble speaking device and HME

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CAUTION: Always assemble the HME with the speaking device (Speaking Valve, HME DigiTop, or HME DigiTop O2) before use (Figure 6a, 6b, 6c, 6d, 7a, and 7b). If the device is not properly assembled, the ProTrach HME 22 can get stuck

in the tracheostomy tube and be difcult to remove in case

of blockage.

1. Place the HME on a at surface:

For ProTrach HME 15 with the narrow part down and the

open foam surface up (Figure 6a or 6c).

For HME 22 with the plastic grid down and the open foam

surface up (Figure 6b or 6d).

2. Put the speaking device on top of the HME and push it

down until it clicks in place.

3. Check that the speaking device is rmly attached to the

HME.

2.2 Insertion and usage of Speaking Valve

with HME 15 / 22

If the Connection Strap is used, attach the clip to the neckband (Figure 8).

Attach the combined Speaking Valve and HME to the connector of the tracheostomy tube (Figure 9). Caution: HME 15 users should always attach the combined Speaking Valve and HME 15 to the connector gently, using a 1/4 twist in a clockwise motion. If the device is pushed too hard it can

get stuck on the tracheostomy tube and be difcult to remove

in case of blockage.

If you have not used HMEs previously, you should be aware that the device may increase breathing resistance to some extent.

You can now switch between speaking mode and HME

mode based on your speaking needs, humidication needs,

and breathing resistance needs (Figure 10). Caution: When changing modes, make sure that you only rotate the lid of

the Speaking Valve, not the entire device. Rotation of the

whole device might cause uncomfortable movement of the tracheostomy tube.

In case you feel increased breathing resistance after coughing, take out the device and wipe off the mucus, or replace the HME with a new one. Also clear the tracheostomy tube from mucus when necessary. If you feel the need to cough heavily, it is recommended that you try to remove the device from the tube prior to coughing. This prevents the device from falling

off and prevents the HME from getting clogged by mucus. If the

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membrane pops out through the holes in the lid of the Speaking Valve when coughing, rotate the lid, and the membrane will get back to the correct position.

Speaking mode

The Speaking Valve is put in speaking mode by rotating the

lid until it clicks into the speaking mode position (the exible

membrane covers the openings of the lid). In speaking mode the membrane only opens when you breathe in. It is closed when you breathe out, so you will breathe out through your mouth and nose, and you will be able to speak. You may feel a somewhat higher breathing resistance in speaking mode than in HME mode due to the membrane. You can now try to speak some words, beginning with low volume and pressure.

HME mode

The Speaking Valve is put in HME mode by rotating the lid

until it clicks into the HME mode position (i.e., the exible

membrane does NOT cover the openings of the lid). HME mode allows you to both breathe in and out through the HME, thereby conditioning the inhaled air.

Note that increased mucus production may appear during

the rst weeks of HME use. With Speaking Valve Blue (REF 7755), the colored membrane

makes it easier to see whether the valve is in speaking mode or in HME mode.

2.3 Insertion and usage of HME DigiTop and HME DigiTop O

Assemble and insert the speaking device as described in 2.1.

If you use the HME DigiTop O2 always assemble and disassemble the oxygen tubing while the device is disconnected from the trach-tube. This is to avoid uncomfortable movement of the trach-tube.

Make sure that the oxygen tubing is securely attached; it should be assembled beyond the conical edge (Figure 15).

If you have not used HMEs previously, you should be aware that the device may increase breathing resistance to some extent.

When you occlude the two holes on the sides with your

ngers, exhaled air will be redirected through your upper airways and you will be able to speak (Figure 11). Releasing the nger occlusion will allow you to inhale again through the

device. The two openings in the HME DigiTop / HME DigiTop

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O2 allow you to breathe in and out through the device, thereby conditioning the inhaled air continuously.

Note that increased mucus production may appear during

the rst weeks of HME use.

2.4 Removal of the HME from the speaking devices

If you use the HME DigiTop O2 remove the oxygen tubing as described above before you start to remove the HME. The HME is intended for single use, and must be replaced at least every 24 hours, or more often if needed. It should be removed before cleaning the speaking devices and should also be replaced if it becomes clogged by mucus. CAUTION: Do not wash the HME since the important HME function then is lost.

HME 15

1. Remove the combined speaking device and HME 15

(without separating them) from the tracheostomy tube with a gentle pulling twist in a clockwise motion.

2. Hold the speaking device with one hand, and pull the

Removal Aid over the HME with the other hand (Figure

12a).

3. Pull the speaking device apart from the HME with a steady grip (Figure 12b or 12c).

4. Discard the HME 15 (Figure 12d).

HME 22

1. Remove the combined speaking device and HME 22

(without separating them) from the tracheostomy tube.

2. Hold the speaking device with one hand, and pull the

Removal Aid over the HME with the other hand (Figure

13a)

3. Press the handles together (Figure 13b) and the HME 22 will crack and loosen from the speaking device (Figure 13c or 13d).

4. Discard the HME 22 (Figure 13e).

2.5 Pediatric Use

If selected properly, ProTrach DualCare can be used by children

of all ages, provided that it ts the local anatomy. This can

change as the child grows. In children with a short neck or a high tracheostomy site, the device may contact the chin which

may be uncomfortable and can cause the Speaking Valve to

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twist modes inadvertently. A tracheostomy tube extender may prevent this from occurring. The ability to handle the device independently depends on the dexterity and developmental maturity of the child. Until the child is able to handle the device independently, supervision by a parent or caregiver while using the device is obligatory (see Contraindications). The indications and contra-indications for the use of the HME DigiTop and the HME DigiTop O2 are the same for adults and children. However, manual occlusion for speaking may not be

possible if the ngers of the child are too small. In such a case,

the supervising parent or caregiver can occlude the device. The indications and contra-indications for the use of the

Speaking Valve are the same for adults and children. The ability to connect and disconnect the device from the tube, assemble and disassemble the device, and twist the device between modes depends on the dexterity and developmental maturity of the child. These tasks need to be performed by the supervising parent or caregiver until the child is able to handle the device independently.

2.6 Cleaning and disinfection

2.6.1 Cleaning of the speaking devices

In order to keep the speaking devices (Speaking Valve and HME DigiTop) clean and in a good working condition, they should be cleaned daily. If used, the Connection Strap can be cleaned together with the Speaking Valve.

CAUTION: Do NOT boil the device and do NOT use hydrogen peroxide for disinfection since this will damage the device.

1. Remove the HME from the speaking device as described

above.

2. Flush the oxygen port connector of HME DigiTop O (if used), with oxygen or air to remove any debris.

3. Rinse the speaking device carefully on both sides under lukewarm (20-40 °C / 68-104 °F) drinking water. Rotate

the Speaking Valve lid back and forth during the rinse.

Rinse the speaking device for 2 minutes (Figure 14a).

4. Mix 2 drops of dish soap in 250 ml warm (35-45 °C / 95-113 °F) drinking water. Do not use boiling water since this may damage the device.

5. Place the speaking device in the mixture for 15 minutes (Figure 14b). Make sure that the Speaking Valve is in

speaking mode (with the membrane covering the openings

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of the lid) before submerging it.

6. Rinse the speaking device on both sides in warm (35-45 °C

/ 95-113 °F) drinking water for 15 seconds. In order to reach all parts of the Speaking Valve, be sure that it is opened and closed a couple of times during rinsing (Figure 14c).

7. Inspect the device with respect to mucus and debris residues.

Repeat the steps above if necessary.

8. Flush the oxygen port connector of HME DigiTop O2 with oxygen or air to remove any remaining water.

9. After cleaning, put the speaking device on a clean gauze and leave it to air-dry for at least 2 hours (Figure 14d). Make sure that the Speaking Valve is in speaking mode.

10. When the speaking device is completely dry, it can either be used again or placed in a clean, closed container for storage.

2.6.2 Disinfection of the speaking devices

It is recommended that the device is disinfected at least once a week or before use if it looks dirty or there has been a risk of contamination. A risk of contamination could exist if the

device has been dropped on the oor or if it has been in contact

with a pet, someone with a respiratory infection, or any other gross contamination. If disinfection is needed always clean the

device rst as described above and then disinfect by using the

following procedure:

1. First follow the cleaning procedure as described in 2.6.1, without step 9 and 10. After cleaning, put the Speaking Valve in speaking mode and submerge it for 10 minutes either in ethanol 70% or isopropyl alcohol 70% (Figure 15a).

CAUTION: Do NOT use hydrogen peroxide.

2. After cleaning and disinfection, put the speaking device on a clean gauze and leave it to air-dry for at least 2 hours (Figure 15b). Make sure that the Speaking Valve is in speaking mode.

3. When the speaking device is completely dry, it can either be used again or placed in a clean, closed container for storage. CAUTION: Do not use the speaking device until it is completely dry. Inhalation of disinfectant fumes can cause severe coughing and irritation of the airways. The HME Dig iTop O oxygen or air before use to remove any disinfection residuals.

oxygen port connector shall be ushed with

2.7 Storage instructions

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When not in use, clean and disinfect the Speaking Valve as described above, and then store it in a clean and dry container at room temperature. Protect from direct sunlight.

2.8 Device lifetime

The HME is for single use and must be replaced at least every 24 hours, or more often if needed.

The Speaking Valve, HME DigiTop, HME DigiTop O2, and Connection Strap may be used for a maximum of 2 months as long as they are intact and are functioning as intended.

2.9 Disposal

Always follow medical practice and national requirements regarding biohazard when disposing of a used medical device.

2.10 Accessories

ProTrach Connection Strap: Can be used to attach the Speaking Valve to the neckband. Removal Aid: Can be used to help to remove the HME from the speaking device.

3. Additional information

3.1 Compatibility with MRI Examination

MR-Safe: This device does not contain any metallic elements

and has no potential for interaction with the MRI eld.

3.2 Ordering information

See end of this Instructions for Use.

3.3 User assistance information

For additional help or information, please see back cover of this Instructions for Use for contact information.

DEUTSCH

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Die diesem Produkt beiliegende Gebrauchsanweisung unterliegt gelegentlichen Änderungen und ist deshalb vor jedem Verfahren, bei dem das Produkt verwendet wird, durchzusehen.

Inhalt

1. Beschreibende Informationen ...............................................25

1.1Verwendungszweck ............................................................25

1.2KONTRAINDIKATIONEN .....................................................25

1.3 Beschreibung des Produkts .............................................27

1.4WARNHINWEISE .................................................................... 29

1.5VORSICHTSMASSNAHMEN ...............................................32

2. Gebrauchsanweisung ...............................................................33

2.1 Vorbereitung und Montage der Sprechprodukte ....33

2.2 Einführung und Gebrauch des Sprechventils

mit HME 15 / 22 ...........................................................................34

2.3 Einführung und Gebrauch der HME DigiTop und der HME DigiTop O

2.4 Entfernen des HME von den Sprechprodukten ........36

2.5Einsatz in der Pädiatrie .......................................................37

2.6 Reinigung und Desinfektion ...........................................38

2.6.1 Reinigung der Sprechprodukte ..............................38

2.6.2 Desinfektion der Sprechprodukte .........................39

2.7 Lagerungshinweise .............................................................39

2.8 Nutzungsdauer des Produkts ..........................................40

2.9 Entsorgung.............................................................................40

2.10Zubehör ................................................................................40

3. Zusätzliche Informationen ......................................................40

3.1Kompatibilität mit MRT-Untersuchungen ..................40

3.2Ordering information (Bestellinformationen) ...........40

3.3Anwenderunterstützung ..................................................40

..........................................................35

Symbolerklärung

Vor direkter Sonneneinstrahlung und Wärme schützen.

Vor Nässe, Regen und sonstiger Feuchtigkeit schützen.

1. Beschreibende Informationen

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1.1Verwendungszweck

ProTrach DualCare ist eine Kombination aus Sprechventil und Wärme- und Feuchtigkeitsaustauscher (Heat and Moisture Exchanger, HME) und ist für spontan atmende tracheotomierte Patienten bestimmt, die über eine Trachealkanüle mit entblocktem Cuff oder eine Trachealkanüle ohne Cuff atmen. Im HME-Modus konditioniert das Produkt die eingeatmete Luft, indem es Wärme und Feuchtigkeit aus der ausgeatmeten Luft zurückhält. Wenn der Deckel des Sprechventils in den Sprechmodus gedreht wird, wird die Luft umgeleitet und das Sprechen ermöglicht. Das gesamte Produkt ist zum Gebrauch für einen einzigen Patienten bestimmt, während die HME-Kasette zum einmaligen Gebrauch bestimmt ist.

Patientenpopulation: Für spontan atmende tracheotomierte Patienten (Erwachsene und Kinder mit einem Körpergewicht von mehr als 10 kg), die über eine Trachealkanüle mit entblocktem Cuff oder eine Trachealkanüle ohne Cuff atmen.

Verwendungsbereiche: Krankenhäuser, Intensivstationen,

subakute Pegeeinrichtungen und häusliche Pege.

1.2KONTRAINDIKATIONEN

Allgemeines

ProTrach HME 15 oder 22 in Kombination mit entweder dem Sprechventil ProTrach DualCare Speaking Valve oder dem Produkt ProTrach HME DigiTop sind kontraindiziert für:

- Nutzung in Kombination mit einem Inline-Respirator.

- Patienten, die das Produkt bei Bedarf nicht selbst handha-

ben oder entfernen können, wenn sie nicht unter ständiger

Aufsicht eines Arztes bzw. einer ausgebildeten Pegekraft

stehen. Dazu gehören zum Beispiel Patienten, die ihre Arme nicht bewegen können, Patienten mit eingeschränktem Bewusstsein oder Patienten mit Krankheiten, mit denen ein Risiko unvorhersehbarer, periodischer Bewusstseinsverluste assoziiert wird.

- Patienten, die den zusätzlichen Totraum von 5 ml bzw. den

zusätzlichen Atemwiderstand von 170 Pa/1,7 cm H vertragen. Dies sollte ein Arzt beurteilen.

- Nicht ansprechbare oder sedierte Patienten. Der Patient

muss ansprechbar und kommunikationsbereit sein, um das

O nicht

Produkt zu benutzen. Der Patient muss in der Lage sein,

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Anweisungen zu befolgen.

Der HME 15 oder 22 in Kombination mit entweder dem Sprechventil oder dem HME DigiTop dürfen NICHT an einer einlumigen Kanüle (d. h. einer Kanüle ohne Innenkanüle)

angebracht werden, es sei denn, der Patient oder die Pegekraft

ist in der Lage, die Kanüle wieder einzuführen, wenn die Kanüle im Notfall entfernt werden muss.

Sprechventil-spezisch

Die Verwendung des Sprechventils (in Kombination mit HME 15 oder 22) ist zusätzlich bei den folgenden Patientengruppen kontraindiziert:

- Laryngektomierte Patienten, da das Produkt die Ausatmung verhindert, falls das Sprechventil versehentlich in den Sprechmodus geschaltet wird.

- Patienten, die an schwerer Aspiration leiden.

- Patienten mit hochgradigen Obstruktionen im Bereich der Trachealkanüle oder der oberen Atemwege, z. B. eine Trachea- oder Larynxstenose, da dies zu Lufteinschlüssen führen kann.

- Patienten mit starker, zähüssiger Sekretproduktion, durch

die das Produkt blockiert werden könnte.

Das Sprechventil NICHT verwenden:

- In Kombination mit einer Trachealkanüle mit geblocktem Cuff. Der Cuff muss vor der Platzierung und während der gesamten Verwendung des Sprechventils vollständig entblockt sein.

- In Kombination mit einer Trachealkanüle mit SchaumstoffCuff.

- In Kombination mit einer Trachealkanüle mit selbstaufblasendem Cuff.

- Wenn die Größe der Trachealkanüle das Passieren von Luft durch die oberen Atemwege nicht zulässt.

- In Kombination mit einem Endotrachealtubus.

Die Verwendung des Sprechventils unter diesen Bedingungen kann die Ausatmung durch die oberen Atemwege behindern und ein Ersticken verursachen!

Das Sprechventil darf NICHT während des Schlafs verwendet werden, da die Atemwege versehentlich blockiert werden können. Während des Schlafs sollte stattdessen das HME DigiTop (in Kombination mit HME 15 oder 22) verwendet werden (Abbildung 2a oder 2b).

1.3 Beschreibung des Produkts

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Das Sprechventil, das HME DigiTop sowie das HME DigiTop O2 werden verwendet, um das Sprechen zu ermöglichen. In dieser Gebrauchsanweisung werden diese daher als „Sprechprodukte“ bezeichnet.

Sprechventil und HME 15 / 22

Das wiederverwendbare Sprechventil wird zusammen mit einem Wärme- und Feuchtigkeitsaustauscher (Heat and Moisture Exchanger, HME) der Größe 15 mm oder 22 mm verwendet, der zum einmaligen Gebrauch bestimmt ist. Der HME wird so platziert, dass er den direkten Kontakt des Sprechventils mit den Atemwegen verhindert. Dadurch wird verhindert, dass das Sprechventil durch Schleim verstopft oder verschmutzt wird.

Das Sprechventil verfügt über zwei Modi: den Sprechmodus und den HME-Modus.

Im Sprechmodus wird eine flexible Membran in den Luftstromöffnungen positioniert, die als wirksames EinwegVentil fungiert. Es öffnet sich beim Einatmen, sodass der Patient durch das Produkt einatmen kann. Während der Ausatmung bleibt die Membran geschlossen und die Luft wird über die oberen Atemwege und die Stimmbänder umgeleitet. Dies ermöglicht dem Patienten das Sprechen. Im Sprechmodus wird die eingeatmete Luft nicht konditioniert, da die ausgeatmete Luft durch die oberen Atemwege entweicht.

Im HME-Modus wird die Membran aus dem Luftstrom weg gedreht, sodass der Patient durch das Produkt sowohl ein- als auch ausatmet. Die eingeatmete Luft wird mit der Wärme und Feuchtigkeit konditioniert, die aus der ausgeatmeten Luft im imprägnierten Medium des HME zurückgehalten werden. Im HME-Modus ist das Sprechen nicht möglich.

Das Produkt wird zwischen den beiden Modi umgeschaltet, indem man am Deckel des Sprechventils dreht, bis er in der gewünschten Stellung einrastet.

Der ProTrach HME 15 ist in zwei Ausführungen erhältlich: als

XtraMoist mit verbesserter Befeuchtung und als Regular mit

geringerem Atemwiderstand. XtraMoist sollte zum Einsatz kommen, wenn der leicht höhere Atemwiderstand vertragen

wird. Regular sollte verwendet werden, wenn ein geringerer Atemwiderstand erforderlich ist, z. B. im Rahmen der ersten

Gewöhnung an die HME-Verwendung oder bei körperlicher Anstrengung.

HME DigiTop und HME DigiTop O

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Die Produkte HME DigiTop und HME DigiTop O2 ermöglichen die Verwendung des HME ohne das Sprechventil. Sie können manuell verschlossen werden, um das Sprechen zu ermöglichen.

Für Patienten, die zusätzlichen Sauerstoff benötigen, bietet das HME DigiTop O2 die Möglichkeit, einen Sauerstoffschlauch mit einem Durchmesser von 3,2 mm (1/8 Inch) an den Sauerstoffanschlusskonnektor anzubringen (Abbildung 16).

ProTrach DualCare Set 15/Set 22 enthält:

Siehe Abbildung 3 (a) 1 Stück ProTrach DualCare Speaking Valve

(b1 oder b2) 30 Stück (b1) ProTrach HME 15 Regular oder (b2) ProTrach HME 22 Regular

Strap (Halteband)

(d) 1 Stück Faden des ProTrach Connection Strap

(Halteband)

(e) 1 Stück ProTrach HME DigiTop

(f) 1 Stück Removal Aid (Entfernungshilfe)

1 Stück ProTrach DualCare –

Gebrauchsanweisung

ProTrach DualCare Speaking Valve/Paket Speaking Valve Blue enthält:

Siehe Abbildung 3 (a) 1 Stück ProTrach DualCare Speaking Valve oder Speaking Valve Blue (c) 1 Stück Clip für das ProTrach Connection

(d) 1 Stück Faden des ProTrach Connection Strap

(e) 1 Stück ProTrach HME DigiTop oder DigiTop

1 Stück ProTrach DualCare –

Strap (Halteband)

(Halteband)

Blue

Gebrauchsanweisung

Technische Daten für ProTrach DualCare

Sprechventil mit HME 15 Sprechventil mit HME 22

Druckabfall bei 30 l/min im

Sprechmodus, HME 15 Regular:

Druckabfall bei 30 l/min im

HME-Modus, HME 15 Regular:

Druckabfall bei 30 l/min im

125 Pa

Sprechmodus:

Druckabfall bei 30 l/min im

35 Pa

HME-Modus:

136 Pa

48 Pa

Sprechventil mit HME 15 Sprechventil mit HME 22

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Druckabfall bei 60 l/min im

HME-Modus, HME 15 Regular:

Druckabfall bei 30 l/min im

Sprechmodus, HME 15 XtraMoist:

Druckabfall bei 30 l/min im

HME-Modus, HME 15 XtraMoist:

Druckabfall bei 60 l/min im

HME-Modus, HME 15 XtraMoist:

Totraum:

(Sprechventil einschl. HME)

* Bei höherer körperlicher Anstrengung, bei der ein geringerer Atemwiderstand erforderlich

ist, wird der Regular HME empfohlen. Daher wurde der XtraMoist nicht unter diesen

Bedingungen getestet.

Sauerstokonzentration gemessen bei:

Atemzugvolumen 1l, Atemfrequenz 10/min, O

DigiTop O2 mit HME 15 70%

DigiTop O

mit HME 22 71%

Druckabfall bei 60 l/min im

123 Pa

HME-Modus:

166 Pa

78 Pa

Totraum:

4,05 ml

(Sprechventil einschl. HME)

-Zufuhr 10l/min

166 Pa

4,62 ml

1.4WARNHINWEISE

Sprechventil-spezisch

(Sprechventil in Kombination mit HME 15 oder 22).

WARNHINWEIS

Wenn eine Trachealkanüle mit Cuff verwendet wird, muss der Cuff vollständig entblockt sein, bevor das Sprechventil

platziert und während es verwendet wird. Der Patient kann nicht atmen, wenn der Cuff nicht vollständig geleert

ist. Rund um die Trachealkanüle und den entblockten

Cuff muss ein ausreichender Luftstrom bestehen. Das Sprechventil darf nicht bei Patienten verwendet werden, die über eine Trachealkanüle mit selbstaufblasendem oder schaumstoffgefülltem Cuff atmen.

Verwendung von Warnetiketten: Die dem Sprechventil beiliegenden Warnetiketten sind am Zuleitungsschlauch des Kontrollballons der Trachealkanüle anzubringen (Abbildung 1).

Überwachung: Patienten mit einer Trachealkanüle mit Cuff, die das Sprechventil verwenden, müssen gemäß Anordnung des Arztes überwacht werden. Eine kontinuierliche Beobachtung ist erforderlich, um sicherzustellen, dass der Patient über die oberen Atemwege ausatmen kann.

WARNHINWEIS

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Aufklärung: Um die korrekte Anwendung des Sprechventils zu gewährleisten, müssen der Patient, die Angehörigen,

das Pegepersonal und alle mit dem Patienten arbeitenden

Personen in den Gebrauch des Sprechventils eingewiesen und über Kontraindikationen, Warnhinweise, Warnetiketten und Vorsichtsmaßnahmen informiert werden.

Zu beachten

- Sicherstellen, dass das Atmungssystem des Patienten für

die Ausatmung rund um die Trachealkanüle und aus der Nasen- und Mundhöhle geeignet ist.

- Sicherstellen, dass der Arzt der Entblockung des Cuffs

beim Patienten zugestimmt hat. Der Cuff muss bei der Verwendung des Sprechventils entblockt werden, sodass die ausgeatmete Luft rund um die Trachealkanüle und durch die oberen Atemwege strömen kann.

- Zum leichteren Sprechen sicherstellen, dass die Größe der

Trachealkanüle so gewählt wurde, dass ein ausreichender Luftstrom rund um die Trachealkanüle möglich ist. Der Cuff an der Kanüle kann auch im entblockten Zustand ein Hindernis darstellen, was bei der Beurteilung der Durchgängigkeit der Atemwege berücksichtigt werden sollte.

- Auf Anordnung des Arztes beurteilen, ob ein Wechsel auf

eine kleinere Trachealkanüle indiziert ist, um einen für die Verwendung des Sprechventils ausreichenden Luftstrom zu erhalten.

- Bei Patienten mit zähüssigem, nicht beherrschbarem Se-

kret, das Atemwegsobstruktionen verursachen kann, muss die Verwendbarkeit des Sprechventils beurteilt werden.

- Beurteilen, ob bei Patienten, die Schwierigkeiten bei der

Verwendung des Sprechventils haben, Atemwegsobstruktionen aufgrund von Stenosen, Gewebemassen, Tracheomalazie, Granulation, Stimmbandlähmung in der Mittellinienposition, Sekret oder einer für die Trachea des Patienten zu großen Trachealkanüle vorliegen können. Wenn die Obstruktion behoben wurde, sollte erneut beurteilt werden, ob das Sprechventil für den Patienten infrage kommt.

Allgemeines

(HME 15 und 22 in Kombination mit Sprechventil oder HME Dig iTop).

+ 166 hidden pages

Atos Medical ProTrach DualCare Instructions For Use Manual

Specifications and Main Features

Frequently Asked Questions

User Manual