laerdal SimMom, Directions For Use Manual, Page: 4 / 50

4
Cautions and Warnings
Regulatory Information
This device complies with Part 15 of the FCC Rules. Operation is
subject to the following two conditions:
1. This device may not cause harmful interference.
2. This device must accept any interference received, including
interference that may cause undesired operation.
Caution
Changes or modifications not expressly approved by the party
responsible for compliance could void the user’s authority to operate
the equipment.
The product is in compliance with the essential requirements
of Council Directive 2004/108/EC on electromagnetic
compatibility (EMC).
The product is in compliance with Council Directive 2011/65/
EU on restriction of the use of certain hazardous substances
(RoHS).
Dispose of in accordance with local requirements and
regulations.
Disclaimer
Use of the SimMom patient simulation system to train personnel
should be undertaken under supervision of suitably trained technical
or medical personnel with an understanding of educational principles
as well as recognized medical protocols. As with all manikins or other
such training devices, there may be approximations, variations and
inaccuracies in anatomical features and the physiological modeling.
This being the case, Laerdal does not guarantee that all features are
completely accurate.
Global Warranty
See the Laerdal Global Warranty Booklet or see www.laerdal.com.
Country of origin - SimMom is made in USA.
Laerdal Medical
P.O. Box 38
226 FM 116
Gatesville, Texas 76528, USA
General Care
To maintain manikin skins, wash hands before use and place the
manikin on a clean surface. Laerdal recommends the following:
– Use gloves during simulation scenarios. Avoid using colored
plastic gloves, as they may cause discoloration of the manikin skin.
– Do not use felt-tipped markers, ink pens, acetone, iodine, or
other staining medications near the manikin. Take care not to
place the manikin on newsprint or colored paper. Staining may
be permanent.
– Clean manikin skins with mild soap and water.
– If a training session involves the use of fluids in the IV arm or
blood and urine bags, drain the arm immediately following the
training session.
– Use only Laerdal Airway Lubricant for airway lubrication, and
apply liberally.
– Use only SimMom & PROMPT Birthing Lubricant (Laerdal
Catalogue No. 377-18850) to lubricate baby, cervix, birth canal,
and modules. Do not use any other lubricant. Do not use
PROMPT Birthing Lubricant (Laerdal Catalogue No. 376-02950,
Limbs & Things No. 50181) or SimMom Birthing Lubricant
(Laerdal Catalogue No. 377-14450, Limbs & Things No. 10191).
Non-approved lubricants can damage the system.
Warning:
SimMom & PROMPT Birthing Lubricant is not for
personal use.
– Rinse, clean, and dry manikin component modules.
– Fold the torso skin back and powder the inside of the torso skin
to decrease friction. Do not spill powder into manikin chest cavity.
– Do not attempt to perform the following techniques on this
manikin due to the inability to properly sanitize the airway:
– Mouth-to-mouth/mouth-to-mask ventilation
– Insertion of simulated vomit or fluids for suctioning
Environment
In cold conditions, wait until the manikin has reached room
temperature before starting up the manikin.
To avoid overheating and reduce wear:
− When using in temperatures above 40°C (104°F), always allow
the manikin to cool down between training sessions.
− When using in a bed, manikin should not be covered with heavy
bedding that prevents heat transfer from the manikin.
General Manikin Handling
Take the following precautions to avoid personal injury or damage to
the product:
– Introduce fluids into the manikin only as directed in this document.
Failure to do so may result in damage to the manikin and its
components.
− Lubricate the oral and nasal airways with the lubricant provided
prior to inserting any instrument, tube, or airway device. Also,
lubricate instruments and tubes prior to use.
− Lubricate cervix, birth canal, and baby before each delivery.
− Do not introduce humidified air into the system during ventilation.
− Do not use the manikin if the internal tubing and cabling is
disconnected.
– Never use the SimMom manikin outdoors in wet conditions, as
this may pose a shock hazard or damage the manikin.
Warning: Do not use automated external chest
compression machines on the manikin.