ear impression requirements...cerumen in ear canal all cerumen that would interfere with obtaining a...
TRANSCRIPT
Cerumen in ear canal All cerumen that would interfere with obtaining a full impression of the unobstructed ear canal should be removed prior to taking the impression. Cerumen embedded in impression A small amount of cerumen on the surface of the impression is normal and acceptable. However, large particles that could fall off during transportation resulting in a void are unacceptable.
Disclaimer The following is not intended to provide instructions for properly and safely obtaining ear canal impressions. It is intended to be a reference for the properly trained practitioner to obtain the correct impression materials and to define the characteristics of an acceptable ear impression. These characteristics are critical for the proper production of Aegisound hearing protection products.
The following guidelines are in no way a substitute for proper training and applicable regulatory licensure.
The impression taking process should only be undertaken by an audiologist or other properly trained personnel.
CONDITIONS TO WATCH FOR
OUTER EAR FILL AREA
EAR IMPRESSION REQUIREMENTS
Impression Material
Otoform® A SoftX or SiliClone® low viscosity impression material. Low viscosity material is critical to prevent expansion of the ear canal during the impression process.
Jaw PositionClosed and relaxed, no jaw movement or talking during the impression material cure period (7-10 minutes typical for SiliClone®)
Impression Depth
The impression material must extend at least 1mm past the completed 2nd bend (3mm past the bend is preferred). The impression must indicate the size and direction of the canal after the 2nd bend.
Material FillThe impression material should fill the entire canal as well as the helix and concha areas of the outer ear.
Ear Dam/Oto-block vent tube If using a vent tube, the tube may be embedded on the surface of the impression as long as the impression material fills around the tube and the surface is well defined.
Fully ImpressedConcha and
Antihelix Boundary
DesiredImpressionArea
Full Impressionof Tragus andAntitragusBoundary
Fully ImpressedConcha and
Antihelix Boundary
DesiredImpressionArea
Full Impressionof Tragus andAntitragusBoundary
Fully ImpressedConcha and
Antihelix Boundary
DesiredImpressionArea
Full Impressionof Tragus andAntitragusBoundary
Fully ImpressedConcha and
Antihelix Boundary
DesiredImpressionArea
Full Impressionof Tragus andAntitragusBoundary
645 Harvey Road, Road, Suite 102 Manchester, NH 03103 Tel: 866.951.1027 Fax: 603.657.1201 www.gentexcorp.com/aegisound Gentex Corporation
Copyright © 2018 Gentex Corporation. Gentex and Aegisound are registered trademarks of Gentex Corporation or its af�liates. Otoform is a registered trademark of Dreve Otoplastik GmbH. SWF-00152 Rev B
ACCEPTABLE IMPRESSION
UNACCEPTABLE IMPRESSIONS
EAR IMPRESSION REQUIREMENTS
Canal Length ■ Inflection point must be identified before assessing acceptable canal length
■ Inflection point: When the curvature of the 2nd bend ends and the canal becomes relatively straight, a clear direction in which the canal is heading in can be determined; the earliest point on the impression where this can be determined is the inflection point
■ Once inflection point is identified,1mm beyond the point is the minimal length needed for production of final product, 3mm beyond is desired
■ Requirements apply to all other perspective views (only 1 shown for example)
3mm Preferred Length
1mm Minimal Length
In�ection Point
3mm Preferred Length
1mm Minimal Length
In�ection Point
RIps/Tears ■ There should be no rips or tears along ear canal
Missing Fill ■ There should be no missing fill along ear canal
Too Short ■ Impression should extend 3mm past inlfection point (see above)
Bubble ■ There should be no bubbles along ear canal
Shiny Surface Area ■ There should be no shiny surface area where fill did not make contact with skin
645 Harvey Road, Road, Suite 102 Manchester, NH 03103 Tel: 866.951.1027 Fax: 603.657.1201 www.gentexcorp.com/aegisound Gentex Corporation
Copyright © 2018 Gentex Corporation. Gentex and Aegisound are registered trademarks of Gentex Corporation or its af�liates. Otoform is a registered trademark of Dreve Otoplastik GmbH. SWF-00152 Rev B
GENTEX CORPORATION
CUSTOM EARPLUG INFORMATION
EARPLUG CLIENT INFORMATION IMPRESSION INFORMATION*
FIRST NAME*DATE IMPRESSIONS TAKEN
[DD/MM/YYYY]
MIDDLE INITIAL IMPRESSION TAKER LAST NAME
LAST NAME* IMPRESSION TAKER FIRST NAME
DATE OF BIRTH [DD/MM/YYYY] IMPRESSION TAKER CONTACT INFO
EMAIL EMAIL
PHONE NUMBER PHONE NUMBER
WORKSITE INFORMATION
(BASE/SQUADRON/COMPANY/ETC)*
UNIQUE FOUR DIGIT IDENTIFIER
CHOSEN BY END USER*
COMPANY NAME*
CONTACT PERSON
PHONE
TYPE OF EARPLUGS AND NUMBER OF EACH REQUESTED (IF KNOWN)Part Number Description Quantity (Pairs) SHIPPING NOTES:
05‐016020 LPCCE Ship Impressions to:
05‐001003 CTE30X
05‐016032 FCCCE
05‐021001 DANR
PURCHASE ORDER NUM.
PAYMENT METHOD
SHIPPING ADDRESS
*Indicates required information
Impression ID numberInspection Date
Disposal Date (3 months after SO received)
Inspection Result ACCEPT Inspector Initials
Reason/Comments
REJECT
‐‐‐‐‐THIS AREA FOR GENTEX FACTORY USE ONLY ‐‐‐‐‐
Each impression shall be individually bagged. Print and include this form.Impression(s) shall be surrounded by corrugate/paper free protective dunnage(bubble wrap, foam sheet, Airpak, etc.)
GENTEX CORPORATION
Attn: Ear Impressions
645 Harvey Road, Suite, 102
Manchester, NH 03103
BILLING METHOD (IF AVAILABLE)
AUDIOLOGIST/HEARING TECHNICIAN COMMENTSCOMPANY INFORMATION
ANY OTHER COMMENTS?:
ANY DIFFICULTIES MEETING
STANDARDS LISTED ON IMPRESSION
REQUIREMENTS FLYER?