Technical Data - Dräger ComortStar Gebrauchsanweisung

Instructions for use ComfortStar enUS English
ComfortStar
Anesthesia masks, sizes 0-6
Trademarks
Trademarks owned by Dräger
Trademark
®
ComfortStar
The following web page provides a list of the countries in which the trade-
marks are registered: www.draeger.com/trademarks
Safety information definitions
WARNING
A WARNING statement provides important information about a po-
tentially hazardous situation which, if not avoided, could result in
death or serious injury.
CAUTION
A CAUTION statement provides important information about a poten-
tially hazardous situation which, if not avoided, may result in minor or
moderate injury to the user or patient or in damage to the medical de-
vice or other property.
NOTE
A NOTE provides additional information intended to avoid inconve-
nience during operation.
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.
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 experi-
ence).
– Every user group has been trained to perform the task.
– Every user group has read and understood the relevant chapters in
this document.
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 prod-
uct.
Symbols
Additional information about the symbols is available on the following
web page: www.draeger.com/symbols
Not made with
Keep away from sunlight
LATEX
natural rubber latex
Consult instructions for
Do not reuse
use
Ambient pressure Storage temperature
Use by Relative humidity
Do not use if package is
Date of manufacture
damaged
Manufacturer Non-sterile
NON
STERILE
LOT Lot number Part number
REF
The product is a medical
MD
Quantity device (CE conformity
assessment procedure)
For USA: Caution: Federal law restricts this device to sale by or on the
Rx only order of a physician.
For your safety and that of your patients
WARNING
Risk of incorrect operation and of incorrect use
Any use of the medical device requires full understanding and
strict observation of all sections of these instructions for use. The
medical device must only be used for the purpose specified under
"Intended use" and in conjunction with appropriate patient moni-
toring.
Strictly observe all WARNING and CAUTION statements through-
out these instructions for use and all statements on medical de-
vice labels. Failure to observe these safety information statements
constitutes a use of the medical device that is inconsistent with its
intended use.
WARNING
To avoid contamination and soiling of the mask, it must remain
packaged until ready to be used.
CAUTION
Installation to the basic device must be in accordance with the instruc-
tions for use for the basic device. Check that this medical device is se-
curely connected to the basic device system.
CAUTION
The medical devices are not available individually.
Only one copy of the instructions for use is included in the clinical pack-
age and must therefore be kept in a location accessible for users.
Mandatory reporting of adverse events
Serious adverse events with this product must be reported to Dräger and
the responsible authorities.
Intended use
Disposable air cushion anesthesia mask for the application of medical
gases in the patient's upper airways without the need to insert any addi-
tional devices in the trachea.
Instructions for Use ComfortStar
Patient target groups
The products are intended for adults, adolescents, children or infants.
WARNING
Risk of patient injury
CPAP application: This mask does not include an anti-asphyxia
valve via which the patient could breathe independently in the
case of failure of the basic device.
Preparation and operation
WARNING
Risk of patient injury
Perform a visual inspection of the mask, of its components, and of
the headgear prior to each use.
Replace the mask or headgear, if signs of wear of the mask, of its
components, or of the headgear become visible.
WARNING
Use only clean and undamaged components.
WARNING
Risk of patient injury
Do not place the mask over open wounds that are prone to infec-
tion.
WARNING
The mask must not constrict the patient's nose or mouth; the pa-
tient must be able to breathe freely and comfortably.
CAUTION
The mask should fit the face comfortably but still provide an effective
seal. Headgear straps are adjustable to stabilize the mask; pulling the
straps too tight may cause skin irritation.
CAUTION
Regularly check the patient's skin under the mask for signs of skin irri-
tation.
If the patient experiences skin irritation, consult a physician.
CAUTION
Dräger recommends monitoring the expired CO
sure is low.
CAUTION
The mask can be attached to connectors that comply with the
ISO 5356-1 standard.
Mask sizes 0 to 2 are suitable for connection to a product with an internal
diameter of 15 mm.
Mask sizes 3 to 6 are suitable for connection to a product with an external
diameter of 22 mm.
Only products with the relevant connection may be connected.
When using a headgear (optional), this must be attached via the hook
ring on the mask.
The mask cushion must expand correctly during inflation so that it fits her-
metically onto the patient's facial contours. A medium pressure in the
mask cushion ensures the best fit and seal.
A syringe (male, without needle) or the two-sided pump ball for air man-
agement (MP01590) is required in order to modify the cushion pressure.
Insert the syringe or the pump ball in the valve, allowing the air volume in
the mask cushion to be increased or decreased.
WARNING
Excessive inflation of the mask cushion may reduce the useful
surface and can lead to obstruction of the airways.
Period of use
The medical device is intended for single use and must be replaced at
least every 24 hours.
Reprocessing
WARNING
The masks and optional accessories have been designed, tested
and manufactured exclusively for disposable use. The above
products must not be reused, reprocessed, or sterilized. Reuse,
reprocessing, or sterilization may lead to a failure of the products
and injury to the patient.
Disposal
Following use, the product must be disposed of in accordance with the
hygiene and waste disposal regulations of the hospital.

Technical data

Material
Mask body PVC (DEHP free)
Mask cushion PVC (DEHP free)
Hook ring PC
PVC – Polyvinyl chloride
PC – Polycarbonate
DEHP – Diethylhexyl phthalate
The components are not made with natural rubber latex.
Ambient conditions
During operation
Temperature 10 to 40 °C (50 to 104 °F)
Ambient pressure 500 to 1200 hPa (7.3 to 17.4 psi)
Relative humidity 10 to 90 %
During storage
Temperature –20 to 60 °C (–4 to 140 °F)
Ambient pressure
Relative humidity
Classification Medical Device
Europe
UMDNS code
Universal Medical Device Nomen-
clature System
Order list
Designation
ComfortStar anesthesia mask, size 0, standard, round,
with hook ring (20 pieces)
ComfortStar anesthesia mask, size 1, standard, with
hook ring (20 pieces)
ComfortStar anesthesia mask, size 2, standard, with
hook ring (20 pieces)
ComfortStar anesthesia mask, size 3, standard, with
hook ring (20 pieces)
ComfortStar anesthesia mask, size 4, standard, with
hook ring (20 pieces)
ComfortStar anesthesia mask, size 5, standard, with
hook ring (20 pieces)
ComfortStar anesthesia mask, size 6, standard, with
hook ring (20 pieces)
ComfortStar anesthesia mask, size 1, scented strawber-
ry, with hook ring (20 pieces)
ComfortStar anesthesia mask, size 2, scented strawber-
ry, with hook ring (20 pieces)
ComfortStar anesthesia mask, size 3, scented strawber-
ry, with hook ring (20 pieces)
ComfortStar anesthesia mask, size 4, scented strawber-
ry, with hook ring (20 pieces)
ComfortStar anesthesia mask, size 1, scented bubble
gum, with hook ring (20 pieces)
ComfortStar anesthesia mask, size 2, scented bubble
gum, with hook ring (20 pieces)
ComfortStar anesthesia mask, size 3, scented bubble
when baseline pres-
2
gum, with hook ring (20 pieces)
ComfortStar anesthesia mask, size 4, scented bubble
gum, with hook ring (20 pieces)
ComfortStar anesthesia mask, size 3, scented mint, with
hook ring (20 pieces)
ComfortStar anesthesia mask, size 4, scented mint, with
hook ring (20 pieces)
ComfortStar anesthesia mask, size 5, scented mint, with
hook ring (20 pieces)
ComfortStar anesthesia mask, size 6, scented mint, with
hook ring (20 pieces)
Headgear, disposable, soft fabric, small
Headgear, disposable, soft fabric, large
Headgear, disposable, soft rubber, small
Headgear, disposable, soft rubber, large
Two-sided pump ball for air management
English / English US
500 to 1200 hPa (7.3 to 17.4 psi)
10 to 90 %
Class IIa
12-453
Part no.
MP01510
MP01511
MP01512
MP01513
MP01514
MP01515
MP01516
MP01521
MP01522
MP01523
MP01524
MP01531
MP01532
MP01533
MP01534
MP01543
MP01544
MP01545
MP01546
MP01559
MP01560
MP01561
MP01562
MP01590
3