Compliance; Safety; General Safety Information - Invacare Medley Ergo Soft Tilt User Manual

1.7 Compliance

This product features the CE mark, in compliance with the Med-
ical Device Regulation 2017/745 Class 1. The launch date of this
product is stated in the CE declaration of conformity.

2 Safety

2.1

General safety information

WARNING!
Compatibility with Invacare®Medley Ergo beds only
This Soft Tilt version is specially designed and must
only be used in conjunction with 90 cm wide Invacare®
Medley Ergo beds.
WARNING!
Risk of falling
If the Soft Tilt is used without or with the wrong
side rails, there is a risk for the end-user to fall out
of the bed.
– Never use the Soft Tilt on a bed without side rails.
– Only use the Soft Tilt in combination with Invacare
side rails listed in 9 Technical Data, page 21.
– Always make sure the side rail is up in the
opposite side of where the care staff is placed OR
one care staff is placed on each side of the bed,
when the manual mode is used.
– Always make sure both side rails are up, when
the automatic mode is activated.
WARNING!
Risk of squeezing and/or suffocation
If the side rails are used without a cover or with a
non-breathable cover, there is a risk of squeezing
and/or suffocation for the end-user.
– Always use a breathable cover for the side rails
when using the Soft Tilt.
WARNING!
Risk of falling and/or squeezing
If the side rails are used without a cover or with a
non-breathable cover, there is a risk of squeezing
and/or suffocation for the end-user.
– Always perform a risk assessment of the end-
user's condition and ability of moving.
– Never use the Soft Tilt if the end-user is anxious
or restless.
– Always make sure the end-user is placed in the
middle of the bed and all body parts are on the
mattress before the wings are moved.
– Never leave the end-user unattended when the
manual mode is used.
– The end-user must never get in or out of the
bed while the wings are moved manually or the
automatic mode is activated.
– The hand control must always be used by care
giver.
IVCMAMED221119
WARNING!
Risk of injury or damage to property
Inappropriate handling of cables can cause electrical
shock and product failure.
– Do not kink, shear or otherwise damage the main
power cord.
– Do not roll the castors over the main power cord.
– Do not bring main power cord into moving parts.
– Disconnect the plug from the mains before
moving the bed.
– Make sure that no cables (mains or from other
equipment) are jammed or damaged, when the
bed is used.
– Keep bed components and accessories at least 30
cm away from a heated surface and not in direct
sunlight.
Mattresses
WARNING!
Safety aspects regarding combination of side rails
and mattresses:
To get the highest possible safety level, when using
side rails on the bed, the minimum and maximum
measures for mattresses, must be respected.
– For correct mattress measures see mattress
tables in chapter 9 Technical Data, page 21.
WARNING!
Risk of entrapment and/or suffocation
To get the highest possible safety level, when using
side rails on the bed, the minimum and maximum
measures for mattresses, must be respected.
– The end-user could get trapped and/or suffocate,
if the horizontal space, between the mattress side
and the inside of the side rail, is too big. Follow
the minimum width (and length) of mattresses
in combination with a side rail, as stated in the
mattress table in chapter 9 Technical Data, page
21 .
– Be aware that using very thick or soft mattresses
(low density), or a combination of these,
increases the risk.
WARNING!
Risk of falling
The end-user can fall over the edge and get seriously
injured, if the vertical distance A between the top
of the mattress and the edge of the side rail/bed
end, is too short. See image above.
– Always keep a minimum distance
on the side of the wing the user is lying on
(secondary wing elevated to max. 12°).
– Follow the maximum mattress height in
combination with the side rail as stated in the
mattress table in chapter 9 Technical Data, page
21.
Safety
A
of 22 cm
A
5