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HME HumidStar Trach Plus
Heat and moisture exchanger
enUS
Trademarks
Trademarks owned by Dräger
Trademark
®
HumidStar
The following web page provides a list of the countries in
which the trademarks are registered:
www.draeger.com/trademarks
1
Safety-related information
1.1
Intended use
Heat and moisture exchanger (HME) for humidifying
respired gases for spontaneously breathing patients with
tracheostomy.
The integrated oxygen port is intended to administer
supplementary oxygen.
Patient target groups
The product is intended for adults and pediatric patients.
1.2
User group requirements
The term "user group" describes the personnel responsible
who have been assigned by the operating organization to
perform a particular task on a product.
1.2.1 Duties of the operating organization
The operating organization must ensure the following:
– Every user group has the required qualifications (e.g.,
has undergone specialist training or acquired specialist
knowledge through experience).
– Every user group has been trained to perform the task.
– Every user group has read and understood the relevant
chapters in this document.
1.2.2 User groups
Clinical users
This user group operates the product in accordance with the
intended use.
Users have medical specialist knowledge in the application
of the product.
1.3
Information on safety instructions
Safety instructions warn against hazards and provide
instructions for safe use of the product. All safety
instructions specify the type of danger and the
consequences of failure to observe the safety instruction.
1.4
Safety instructions
1.4.1 Instructions for use
Failure to use the product in accordance with the
information contained in these instructions for use may
result in personal injury and property damage.
► Follow these instructions for use.
► Use this product only according to its intended use.
► Keep these instructions for use close to hand.
► Follow these instructions for use and those for any
products used in conjunction with this product.
The instructions for use do not contain any information on
the following points:
– Risks that are obvious to users
– Consequences of obvious improper use of the product
– Potentially negative effects on patients with one or more
illnesses
1.4.2 Symbols and product labels
Failure to observe symbols and product labels may result in
personal injury and property damage.
► Observe the symbols and product labels.
1.4.3 Single use
Reuse, reprocessing or sterilization may lead to failure of
the medical device and to injury to the patient.
► The medical device was designed, tested and
manufactured exclusively for single use and for a period
of use not exceeding 24 hours. The medical device must
not be reused, reprocessed or sterilized.
► Following use, the medical device must be disposed of in
accordance with the hospital's infection prevention
policy.
1.4.4 Modifications to the product
Modifications to the product may lead to malfunctions and
unforeseen risks. This may result in injury to the patient or
the user or in property damage.
► Do not modify this product.
1.4.5 Ambient conditions
Operating the product under unsuitable ambient conditions
may compromise its performance.
► When storing or operating this product, observe the
permissible ranges for ambient temperature and relative
humidity.
Instructions for use
|
HME HumidStar Trach Plus
1.4.6 Components
Additional components in the breathing circuit such as filters
or HME increase the dead space and result in the increase
of compliance and resistance.
► The use of additional components therefore requires
particular care and monitoring.
1.4.7 Patient safety
Medical devices that are damaged or incorrectly applied
may lead to malfunctions or personal damage.
► To avoid contamination and soiling, keep the medical
device packaged until ready to be used.
► Do not use the medical device if the packaging is
damaged.
► Check all system components for obstructions, damage,
and foreign matter before installation. Do not use
damaged medical devices.
► Check that all connections are securely fitted and tight.
► Due to an increased risk of fire, oxygen therapy is not
suitable for smokers.
► When administering oxygen, keep open flames, sparks,
or other possible ignition sources away from the device.
► Regularly check the inside of the medical device for
liquids or visible soiling (secretion). If liquids or visible
soiling are found, replace the medical device
immediately.
► The safety valve must always be free and flexible. It
must not be used to connect other products or
accessories.
► The oxygen port must only be used to introduce oxygen.
1.4.8 Use of humidifiers or medication nebulizers
When using an active humidifier or medication nebulizer,
there is a risk of pressure build-up and insufficient patient
ventilation.
► Do not use the product in combination with active
humidifiers or medication nebulizers.
1.5
Further information
1.5.1 Mandatory reporting of adverse events
Serious adverse events with this product must be reported
to Dräger and the responsible authorities.
2
Overview
B
A Safety valve
B Oxygen port
2.1
Symbols
Additional information about the symbols is available on the
following web page: www.draeger.com/md-symbols
Symbol
Explanation
Caution
Manufacturer
Date of manufacture
XXXX
Temperature limitation
Do not reuse
Do not use if package is damaged
Part number
REF
LOT
Lot number
Quantity
Observe the instructions for use
Relative humidity
Symbol
Explanation
Ambient pressure
Non-sterile
NON
STERILE
Do not open with knife
Keep away from sunlight
Keep dry
Use by
The product is a medical device (CE con-
formity assessment procedure)
For USA: Rx
Caution: Federal law restricts this device
only
to sale by or on the order of a physician.
3
Operation
1. Connect the heat and moisture exchanger to the
tracheostomy tube.
2. Check that all connections are securely fitted and tight.
4
Period of use
The user is responsible for regularly replacing the medical
device according to the hospital's hygiene regulations.
The medical device is intended for single use and must be
replaced at least every 24 hours.
5
Disposal
This product must be disposed of in accordance with
national regulations.
6
Technical data
Performance data
Tidal volume range
Internal volume
Insp./exp. resistance at 90
L/min before and after use
A
Insp./exp. resistance at 60
L/min before and after use
Insp./exp. resistance at 30
L/min before and after use
Loss of moisture
Material
Housing
HME medium
Valve
Not made with natural rub-
ber latex
Ambient conditions
During storage and trans-
port
Temperature
Relative humidity
Ambient pressure
During operation
Temperature
Relative humidity
Ambient pressure
Classification Medical
Device Europe
UMDNS code
Universal Medical Device
Nomenclature System –
nomenclature for medical
devices
1) 1 bar = 1 kPa x 100
7
Order list
HumidStar Trach Plus
English
100 to 1500 mL
6 mL
1)
<0.6 mbar
(<0.6 cmH
O)
2
<0.3 mbar (<0.3 cmH
O)
2
<0.1 mbar (<0.1 cmH
O)
2
10.8 mg/L at Vt = 250 mL
14.4 mg/L at Vt = 500 mL
Polypropylene
Polyurethane
Thermoplastic elastomer
–20 to 60 °C (–4 to 140 °F)
5 to 95 % (non-condensing)
570 to 1200 hPa (8.3 to
17.4 psi)
5 to 40 °C (41 to 104 °F)
5 to 95 % (non-condensing)
570 to 1200 hPa (8.3 to
17.4 psi)
Class IIa
15-645
MP05750
3
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