laerdal Thomas Tube Holder, Руководство пользователя

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3
A
B C
English
Indications for use
Thomas Tube Holder is designed to secure single and double-
lumen airway tubes such as Endotracheal Tubes (ETs), Laryngeal
Mask Airways (LMAs) and other Supraglottic Airway devices
(SGAs), after insertion into the trachea or esophagus to reduce
the risk of accidental extubation. It is intended for use on
persons of at least 8 years old with a short-term need (less than
24 hours) for airway-tube device management.
Setup Instructions
• Secure the product as shown (Fig. 1 - 3).
• Ensure correct position of head strap to prevent it from sliding
(Fig. A).
• Release the tube clamp as shown (Fig. B).
•
If necessary, position removable hook tab on strap to
accommodate smaller neck size (Fig. C).
Notes
Important information about the product or its operation.
• The Thomas Tube Holder meets the following standards: EN
1789, ISO 13485, ISO 14971, ISO 10993-1.
• Non-sterile product
Warnings
A Warning states a condition, hazard, or unsafe practice that can
result in serious personal injury or death.
• This device should only be used by trained personnel in
accordance with the User Guide.
• Apply just enough pressure against the tube to hold securely in
place. Overtightening of the screw may restrict airflow.
• Do not use on children younger than 8 years old.
• Designed for single patient use only. Do not re-use. Re-use
will lead to increased risk of cross-contamination, degradation
of performance and/or device malfunction. Laerdal is not
responsible for any consequences of re-use.
• Prior to use, inspect all parts to ensure they are free of damage
and working properly.
• The patient should be constantly monitored while this product
is in use.
Cautions
A Caution states a condition, hazard, or unsafe practice that can
result in minor personal injury or damage to the Thomas Tube
Holder.
• The device should only be attached to the patient after insertion
of an advanced airway device.
• Do not use the device on a patient if it has been used during
training.
• Do not disinfect or sterilize the product.
• The device is for short term use only. Remove after 24 hours.
• Storage temperature: -34 °C to +52 °C (-30 °F to 124 °F).
• Operating temperature: -18 °C to +43 °C (-0 °F to 109°F).
Symbol Glossary
This medical device complies with the general
safety and performance requirements of
Regulation (EU) 2017/745 for medical devices.
Caution: Federal law (US) restricts this device
to sale by or on the order of a physician or
appropriately licensed practitioner.
Single Patient Use. Do not re-use.
Reference order and number
Unique Device Identification
Medical Device
Not for use on children under 8 years old
Storage temperature (Maximum and Minimum)
Size range for supraglottic devices
Size range for tracheal tubes (Outer Diameter)
Not made with natural rubber latex
Materials
Part Material
Foam Polyethylene foam - PE
Strap Polyurethane foam - PU
Polyester flannel - PET
Polyamide - PA
Mouthpiece Polypropylene - PP
Other parts Polyoxymethylene - POM
The materials have not been tested for flammability.
Dispose of according to local protocol.
Thomas Tube Holder is protected by US patent # 8,360,063
and other international patents. Thomas and Laerdal are
trademarks owned by Laerdal Medical AS. Ownership and all
rights reserved.
Global warranty: www.laerdal.com