Proactive Protekt Akra PMSEBHR User manual

For Use with Model’s:
Protekt Akra-SE™ Semi-Electric Bed, Spring Deck, Half Rails PMSEBHR
Protekt Akra-SE™ Semi-Electric Bed, Spring Deck, Full Rails PMSEBFR
Protekt Akra-FE™ Full-Electric Bed, Spring Deck, Half Rails PMFEBHR
Protekt Akra-FE™ Full-Electric Bed, Spring Deck, Full Rails PMFEBFR
Protekt Akra™Home Care Beds
User Manual & Entrapment Guide

3
Table Of Contents
User Manual ...................................... 4 — 11
Special Notes ...........................................1
Warnings ..............................................4
Frame Assembly Instructions...............................5
Bed Assembly Instructions.................................6
Drive Shaft Assembly ..................................6 – 7
Bed Operation ....................................... 7 – 9
Pendant Hand Control ................................7
Motor Assembly .....................................8
Crank Operation .....................................9
Head/Foot Board Height Adjustment........................10
Specications..........................................10
Maintenance and Safety Checks ...........................11
Electronics.........................................11
Bed Frame and Sleeping Surface .......................11
Cleaning ..........................................11
Lubrication and Mechanical ...........................11
Warranty ..............................................11
Entrapment Guide ................................ 12 — 19
Key Body Parts at Risk...................................12
Head .............................................12
Neck .............................................12
Chest.............................................12
Potential Zones of Entrapment.............................13
Dimensional Limits for Identied Entrapment Zones ....... 13 — 17
A Guide to Bed Safety ...................................17
’ Needs for Safety .......................18
Patient or Family Concerns about Bedrail Use ................19
User Manual....................................... 4 - 11
Special Notes ..........................................4
Warnings ..............................................4
Frame Assembly Instructions ..............................5
Bed Assembly Instructions ................................6
Drive Shaft Assembly ................................. 6 - 7
Bed Operation ....................................... 7 - 9
Pendant Hand Control ................................7
Motor Assembly .....................................8
Crank Operation.....................................9
Head/Foot Board Height Adjustment .......................10
Specications .........................................10
Maintenance and Safety Checks ..........................11
Electronics ........................................11
Bed Frame and Sleeping Surface ......................11
Cleaning ..........................................11
Lubrication and Mechanical...........................11
Warranty .............................................11
Entrapment Guide ................................. 12 - 19
Key Body Parts at Risk ..................................12
Head.............................................12
Neck .............................................12
Chest ............................................12
Potential Zones of Entrapment ............................13
Dimensional Limits for Identied Entrapment Zones ....... 13 - 17
A Guide to Bed Safety...................................17
Protekt® Home Care Beds Part List
.........................18
Meeting Patients’ Needs for Safety.........................19
Patient or Family Concerns about Bedrail Use ................19

4
SPECIAL NOTES
NOTICE:
• The information contained in this document is subject to
change without notice.
• WARNINGS/CAUTION notices used in this manual apply to
hazards or unsafe practices which could result in personal
injury and/or property damage.
• Check all parts for shipping damage and test before using.
In case of a damage, do NOT use.
• Contact the dealer for further instruction.
WARNING
PLEASE READ ALL WARNINGS/CAUTIONS BEFORE USE
• Your Manual/ Electric bed has been totally engineered to pro-
vide you with reliable operation and the strength you deserve.
• The bed has been thoroughly tested and inspected prior to
shipment.
• The utmost in comfort and safety has been provided for you.
The bed is for your HOME use only.
• It is NOT for hospital use and was not designed to meet hospi-
tal standards.
• DO NOT use near explosive gases.
• Possible re hazard when used with oxygen administering
equipment other then nasal or masked type.
• When using nasal or masked type administering equipment,
oxygen or air tubing MUST be routed and secured properly to
ensure that tubing does NOT become entangled and eventually
severed during normal operation of Manual/ Electric bed.
WARNING
•When using liquids in or around the bed, caution should be
taken to ensure that liquids of any kind are not spilled in or
around the bed.
• If a spill occurs, UNPLUG the bed immediately.
•Clean up spill and allow bed or area to dry thoroughly before
using the electric controls again.
•Close supervision is necessary when this product is used by or
near CHILDREN OR PHYSICALLY CHALLENGED INDIVIDUALS.
• This product should never be left unattended when plugged in.
• NEVER PERMIT ANY ONE UNDER THE BED AT ANYTIME.
• When operating or moving the bed, ALWAYS ensure that the
individual utilizing the bed is positioned properly within the
connes of the bed.
• DO NOT let any extremities protrude over the side or between
the bed rails when performing these functions.

5
FRAME ASSEMBLY INSTRUCTIONS
NOTE: Spring fabric not shown for clarity.
• Lay the head and foot section on their sides approximately
90º to each other (See Figure 1).
• Slide the sections together until the hook on the foot section
catches the rivet on the head section.
• Straighten sections and position as shown in figure 2.
• Position head wing as shown.
• With the two sections level, install a frame lock pin into each side
of the frame as shown in figure 3.
• Be sure to properly install frame lock pins before use.
•NOTE: Lock pins must be installed to ensure safe operation/use.
• Attach fabric halves together using spring clips, which are
attached to the foot fabric. (See Below)

6
BED ASSEMBLY INSTRUCTIONS
• Standing directly in front of the bed end, position it as close
to the bed as possible.
• With one hand reach over end and lift up bed.
• Tilt the bed end slightly back toward you.
• Engage lower rivet slightly and tilt end toward bed.
• Lower bed into corner lock.
• Repeat for head end.
DRIVE SHAFT ASSEMBLY
• The drive shaft is comprised of two sections —inner
and outer tubes.
• Depress spring button and insert until desired hole is reached.

7
DRIVE SHAFT ASSEMBLY (CONT.)
• Connect the drive shaft assembly to the bed by rst attaching
either side of the drive shaft to the foot end gearbox. Then attach
other end to head end gearbox.
BED OPERATION —PENDANT HAND CONTROL
• In the event of a power failure, use a standard 9V battery to lower
the bed’s head and foot sections.
• When used with the battery, the motor will only lower, not lift, the
head and/or foot sections.

8
BED OPERATION (CONT.) —MOTOR ASSEMBLY
Remove Motor Side Caps
• Remove the slide caps from both ends of the motor as
shown below.
• Plungers should be recessed in motor cavities; if not, operate
the “down” function on the pendant hand control until plunger is
recessed.
Install Motors
• Hold the bed securely, positioned with motor cams up,
as shown below.
• Position the motor over both cams.
• Tap either end of the motor housing (shown below) with enough
force to snap the motor assembly into position on the cam.
• Repeat for other end of motor.
NOTE: This is a bearing surface requiring a tight t; it may require
a hardy hit with palm of hand to snap over motor tube.

9
BED OPERATION (CONT.) —CRANK OPERATION
Use the crank at the center of the foot board of the semi-electric bed
to change the entire deck height.
To raise bed – Turn the crank handle clockwise.
To lower bed – Turn the crank handle counter-clockwise.
Trendelenberg position
1) Lower bed to its lowest height. Disengage the hi/lo rod by
compressing the spring tting and removing the hi/lo rod
from the motor or bed end.
2) Raise the foot bed end using the pendant hand control or crank
(semi-electric bed only).
3) The head end will remain in the low position.
Reverse Trendelenberg
4) Raise bed to its highest height. Disengage the hi/lo rod by com-
pressing the spring tting and removing the hi/lo rod from the
motor or bed end.
5) Lower the foot bed end using the pendant hand control or crank
(semi-electric bed only).
6) The head end will remain in the high position.

10
HEAD/FOOT BOARD —OPTIONAL HEIGHT ADJUSTMENT
Pin Installation
• Rotate the crank handle clockwise to raise the bed to the desired
height. (Fig. 1)
• Insert lock pin through adjustment hole. (1" increments)
NOTE: If lock pin cannot insert through the holes easily, rotate
the crank handle (clockwise or counter-clockwise) until the lock
pin goes through. (Fig. 2)
• Secure lock pin with safety pin provided. (Fig. 3)
• Repeat on each remaining leg.
SPECIFICATIONS
The deck height of the bed can be adjusted from 15" – 24"
Electrical Motor is ETL Approved
Weight Capacity 450 lbs.
Construction Frame: 11ga (.120) hot rolled steel.
Sleeping surface: Zinc plated steel wire and coils.
Finish Durable Powder Coating

11
MAINTENANCE AND SAFETY CHECKS
To be performed once per year or between patient placements.
Electronics
Check all controls to make sure all functions work properly.
• Power cord
• Pendant cord
• Check to make sure all wires are routed and attached properly
so they do not interfere with any moving parts
• Check to make sure all plugs are fully inserted or attached
Bed Frame and Sleeping Surface
Visually check all welds
• Head section
• Knee section
• Main Frame
• Check joints between sleeping surface sections for
loose fasteners.
Cleaning
The metal parts of the bed are covered with a baked epoxy
coating Clean all coated parts with mild detergent and warm water
Periodically raise head and feet sections of the bed and remove
dust from frame Also, periodically remove the mattress and clean
mattress deck.
Lubrication and Mechanical
• Lightly grease all actuator screw threads with white lithium grease
• Lubricate all caster roller and swivel bearings with light machine oil
• Check all bolts and tighten as needed.
WARRANTY
• Limited lifetime on frame
• 2 Years on Motor

12
KEY BODY PARTS AT RISK
Three key body parts at risk for life-threatening entrapment in the
seven zones of a hospital bed system discussed in this guidance are
the head, neck, and chest.
The body part dimensions used to develop FDA’s dimensional
limit recommendations are summarized as follows:
Key Body Part Dimension
Head 120 mm (4-4inches)
Neck 60 mm (2-8inches
and angle >60º
Chest 318 mm (12-2inches)
Head
To reduce the risk of head entrapment, openings in the bed
system should not allow the widest part of a small head (head
breadth measured across the face from ear to ear) to be trapped.
FDA is therefore using a head breadth dimension of 120 mm
(4-¾ inches) as the basis for its dimensional limit recommenda-
tions. This dimension is consistent with the dimensions recom-
mended by the HBSW and the IEC.
Neck
To reduce the risk of neck entrapment,
openings in the bed system should not
allow a small neck to become trapped.
Given the adult population at risk for
wedging entrapments in hospital beds,
FDA recommends a dimension of 60 mm
(2-3/8inches) to represent neck diameter.
Additionally, to prevent wedging, a limit of greater than
60º is recommended for V-shaped openings that a neck
could enter. These dimensions are consistent with the
dimensions recommended by the HBSW and the IEC
(see IEC 60601-2-38-1).
Chest
The openings in a bed system should be wide enough not to
trap a large chest through the opening between split rails.
FDA concurs with the IEC recommended dimension of 318 mm
(12-½ inches) to represent chest depth for the population
vulnerable to entrapment, and has used this dimension as
the basis for its recommended dimensional limits.
ENTRAPMENT GUIDE
Bed Rails in Nursing Homes and the Home Health Care Environment

13
POTENTIAL ZONES OF ENTRAPMENT
This guidance describes seven zones in the hospital bed system
where there is a potential for patient entrapment. Entrapment may
occur in at or articulated bed positions, with the rails fully raised
or in intermediate positions.
The seven areas in the bed system where there is a potential for
entrapment are identied in the drawing below.
Zone 1 Within the rail
Zone 2 Under the rail, between the rail supports or next to
a single rail support
Zone 3 Between the rail and the mattress
Zone 4 Under the rail, at the ends of the rail
Zone 5 Between split bed ends
Zone 6 Between the end of the rail and the side edge of the
head or foot board
Zone 7 Between the head or foot board and the mattress end
DIMENSIONAL LIMITS FOR IDENTIFIED
ENTRAPMENT ZONES
Summary of FDA Hospital Bed Dimensions Limit Recommendations
Zone Dimensional Limit Recommendations
1. Within the rail < 120 mm (< 4-¾ inches)
2. Under the rail, between
rail supports or next to
a single rail support
< 120 mm (< 4-¾ inches)
3. Between the rail and
mattress
< 120 mm (< 4-¾ inches)
4. Under the rail, at the
ends of the rails
<60 mm (< 2-3∕8”) AND > 60° angle
Zone 1 — Within the Rails
This is any open space within the perimeter of the rail. Openings
in the rail should be small enough to prevent the head from entering.
A loosened bar or rail can change the size of the space. The HBSW
and IEC recommend that the space be less than 120 mm
(4-¾ inches), representing head breadth.

14
Zone 2 —Under the Rail, Between the Rail Supports
or Next to a Single Rail Support
This space is the gap under the rail between a mattress compressed
by the weight of a patient’s head and the bottom edge of the rail at
a location between the rail supports, or next to a single rail support.
If there is a single rail support, entrapment in Zone 2 can occur
anywhere along the bottom length of the rail beyond the support,
up to the end of the rail. (Entrapment at the end of the rail is
explained in Zone 4.) Factors to consider are the mattress
compressibility 17 which may change over time due to wear, the
lateral shift of the mattress or rail, and any degree of play from
loosened rails or rail supports. A restless patient may enlarge the
space by compressing the mattress beyond the specied
dimensional limit. This space may also change with different rail
height positions and as the head or foot sections of the bed are
raised and lowered. The space may increase, decrease, become less
accessible, or disappear entirely. In some positions, the potential for
entrapment in this zone may still exist when the deck is articulated.
Preventing the head from entering under the rail would most likely
prevent neck entrapment in this space. FDA recommends that this
space be small enough to prevent head entrapment,less than 120
mm (4 ¾ inches). IEC recommends the same dimensions but mea-
sures the space without the mattress in place.
Zone 3 —Between the Rail and the Mattress
This area is the space between the inside surface of the rail and the
mattress compressed by the weight of a patient’s head. The space
should be small enough to prevent head entrapment when taking into
account the mattress compressibility, any lateral shift of the mat-
tress or rail, and degree of play from loosened rails. HBSW and IEC
recommend a dimension of less than 120 mm (4 ¾ inches) because
the head is presumed to enter the space before the neck. FDA is rec-
ommending a dimensional limit of less than 120 mm (4 ¾ inches) for
the area between the inside surface of the rail and the compressed
mattress.

15
Zone 4 —Under the Rail at the Ends of the Rail
This space is the gap that forms between the mattress compressed
by the patient, and the lowermost portion of the rail, at the end of
the rail. Factors that may increase the gap size are: mattress com-
pressibility, lateral shift of the mattress or rail, and degree of play
from loosened rails. The space poses a risk for entrapment of a
patient’s neck. It may change with different rail height positions and
as the head or foot sections of the bed are raised and lowered. The
space may increase, decrease, become less accessible, or disappear
entirely. Thus, in some positions, the potential for entrapment in this
zone may still exist when the deck is articulated.
At the time of this publication, the IEC international standard rec-
ommends a dimensional limit of less than 60 mm (2 3/8 inches)
measured between the mattress support platform and the lowest
portion of the rail at the rail end to prevent neck entrapment. Based
on the neck diameter dimension described above, FDA recommends
that the dimensional limit for this space also be less than 60 mm (2
3/8 inches). To reduce the risk of neck entrapment at Zone 4, FDA
recommends consideration of the combination of the gap size and
the angle size (created between the mattress and the rail). Thus, FDA
recommends that the V-shaped opening under the rail at its end be
of an angle wide enough, i.e. greater than 60 degrees, to prevent
wedging entrapment
Zone 5, 6 and 7
Although seven potential zones of entrapment have been
identied by HBSW, FDA is recommending dimensional limits
for zones 1-4 because these zones were most frequently reported
as having entrapments.
FDA continues to receive entrapment reports for Zones 5 and 6,
and Zone 7 remains a potential for entrapment. FDA will monitor
entrapments in these zones and consider harmonization with the IEC
standard once it is available.

16
Zone 5 —Between Split Bed Rails
This zone occurs when partial length head and foot side rails (split
rails) are used on the same side of the bed. The space between
the split rails may present a risk of either neck entrapment or chest
entrapment between the rails if a patient attempts to, or accidental-
ly, exits the bed at this location. In addition, any V-shaped opening
between the rails may present a risk of entrapment due to wedging.
FDA recognizes this area as a potential for entrapment and encour-
ages facilities and manufacturers to report entrapment events at this
zone.
Zone 6 —Between the End of the Rail and the
Side Edge of the Head or Foot Board
This is the space between the end of the rail and the side edge of the
headboard or footboard. This space may present a risk of either neck
entrapment or chest entrapment. In addition, any V-shaped opening
between the end of the rail and the head or footboard may present
a risk of entrapment due to wedging. This space may change when
raising or lowering the head or foot sections of the bed. This space
may increase, decrease, become less accessible, or disappear en-
tirely. Thus, in some positions, the potential for entrapment may exist
when the deck is articulated. FDA recognizes this area as a potential
for entrapment and encourages facilities and manufacturers to report
entrapment events at this zone.

17
Zone 7 —Between the Head or Foot Board
and the End of the Mattress
This is the space between the inside surface of the head board or
foot board and the end of the mattress. This space may present a
risk of head entrapment when taking into account the mattress com-
pressibility, any shift of the mattress, and degree of play from loos-
ened head or foot boards. FDA recognizes this area as a potential for
entrapment and encourages facilities and manufacturers to report
entrapment events at this zone.
Patient Safety
Patients who have problems with memory, sleeping, incontinence,
pain, uncontrolled body movement, or who get out of bed and walk
unsafely without assistance, must be carefully assessed for the best
ways to keep them from harm, such as falling. Assessment by the
patient’s health care team will help to determine how best to keep
the patient safe. Historically, physical restraints (such as vests, ankle
or wrist restraints) were used to try to keep patients safe in health
care facilities. In recent years, the health care community has
recognized that physically restraining patients can be dangerous.
Although not indicated for this use, bed rails are sometimes used as
restraints. Regulatory agencies, health care organizations, product
manufacturers and advocacy groups encourage hospitals, nursing
homes and home care providers to assess patients’ needs and to
provide safe care without restraints.

18
The Benefits and Risks of Bed Rails
Potential benets of bed rails include:
• Aiding in turning and repositioning within the bed.
• Providing a hand-hold for getting into or out of bed.
• Providing a feeling of comfort and security.
• Reducing the risk of patients falling out of bed when
being transported.
• Providing easy access to bed controls and personal care items.
Potential risks of bed rails may include:
• Strangling, suffocating, bodily injury or death when patients
or part of their body are caught between rails or between the
bed rails and mattress.
• More serious injuries from falls when patients climb over rails.
• Skin bruising, cuts, and scrapes.
• Inducing agitated behavior when bed rails are used as a restraint.
• Feeling isolated or unnecessarily restricted.
• Preventing patients, who are able to get out of bed, from
performing routine activities such as going to the bathroom
or retrieving something from a closet.
Which Ways of Reducing Risks are Best?
A process that requires ongoing patient evaluation and monitoring
will result in optimizing bed safety. Many patients go through a period
of adjustment to become comfortable with new options. Patients and
their families should talk to their health care planning team to nd out
which options are best for them.
MEETING PATIENTS’ NEEDS FOR SAFETY
Most patients can be in bed safely without bed rails.
Consider the following:
• Use beds that can be raised and lowered close to the oor
to accommodate both patient and health care worker needs.
• Keep the bed in the lowest position with wheels locked.
• When the patient is at risk of falling out of bed, place mats next to
the bed, as long as this does not create a greater risk of accident.
• Use transfer or mobility aids.
• Monitor patients frequently.
• Anticipate the reasons patients get out of bed such as hunger,
thirst, going to the bathroom, restlessness and pain; meet these
needs by offering food and uids, scheduling ample toileting,
and providing calming interventions and pain relief.
When bed rails are used, perform an on-going assessment of the
patient’s physical and mental status; closely monitor high-risk
patients. Consider the following:
• Lower one or more sections of the bed rail, such as the foot rail.
• Use a proper size mattress or mattress with raised foam edges
to prevent patients from being trapped between the mattress
and rail.
• Reduce the gaps between the mattress and side rails.
The Benets and Risks of Bed Rails
Potential benets of bed rails include:
● Aiding in turning and repositioning within the bed.
● Providing a hand-hold for getting into or out of bed.
● Providing a feeling of comfort and security.
● Reducing the risk of patients falling out of bed when being
transported.
● Providing easy access to bed controls and personal care
items.
Potential risks of bed rails may include:
● Strangling, suocating, bodily injury or death when patients or
part of their body are caught between rails or between the bed
rails and mattress.
● More serious injuries from falls when patients climb over rails.
● Skin bruising, cuts, and scrapes.
● Inducing agitated behavior when bed rails are used as a re-
straint.
● Feeling isolated or unnecessarily restricted.
● Preventing patients, who are able to get out of bed, from
performing routine activities such as going to the bathroom or
retrieving something from a closet.
Which Ways of Reducing Risks are Best?
A process that requires ongoing patient evaluation and monitoring
will result in optimizing bed safety. Many patients go through a
period of adjustment to become comfortable with new options.
Patients and their families should talk to their health care planning
team to nd out which options are best for them.

19
PATIENT OR FAMILY CONCERNS ABOUT BED RAIL USE
If patients or family ask about using bed rails, health care
providers should:
• Encourage patients or family to talk to their health care planning
team to determine whether or not bed rails are indicated.
• Reassure patients and their families that in many cases the
patient can sleep safely without bed rails.
• Reassess the need for using bed rails on a frequent, regular basis.
To report an adverse event or medical device problem,
please call FDA’s MedWatch Reporting Program at
1-800-FDA-1088.
For additional information, visit the FDA’s website at:
http://www.fda.gov/medicaldevices
18
The Benefits and Risks of Bed Rails
Potential benets of bed rails include:
• Aiding in turning and repositioning within the bed.
• Providing a hand-hold for getting into or out of bed.
• Providing a feeling of comfort and security.
• Reducing the risk of patients falling out of bed when
being transported.
• Providing easy access to bed controls and personal care items.
Potential risks of bed rails may include:
• Strangling, suffocating, bodily injury or death when patients
or part of their body are caught between rails or between the
bed rails and mattress.
• More serious injuries from falls when patients climb over rails.
• Skin bruising, cuts, and scrapes.
• Inducing agitated behavior when bed rails are used as a restraint.
• Feeling isolated or unnecessarily restricted.
• Preventing patients, who are able to get out of bed, from
performing routine activities such as going to the bathroom
or retrieving something from a closet.
Which Ways of Reducing Risks are Best?
A process that requires ongoing patient evaluation and monitoring
will result in optimizing bed safety. Many patients go through a period
of adjustment to become comfortable with new options. Patients and
their families should talk to their health care planning team to nd out
which options are best for them.
MEETING PATIENTS’ NEEDS FOR SAFETY
Most patients can be in bed safely without bed rails
.
Consider the following:
•
Use beds that can be raised and lowered close to the oor
to accommodate both patient and health care worker needs.
•
Keep the bed in the lowest position with wheels locked.
•
When the patient is at risk of falling out of bed, place mats next to
the bed, as long as this does not create a greater risk of accident.
•
Use transfer or mobility aids.
•
Monitor patients frequently.
•
Anticipate the reasons patients get out of bed such as hunger,
thirst, going to the bathroom, restlessness and pain; meet these
needs by offering food and uids, scheduling ample toileting,
and providing calming interventions and pain relief.
When bed rails ar
e used, perform an on-going assessment of the
patient’s physical and mental status; closely monitor high-risk
patients
. Consider the following:
•
Lower one or more sections of the bed rail, such as the foot rail.
•
Use a proper size mattress or mattress with raised foam edges
to prevent patients from being trapped between the mattress
and rail.
•
Reduce the gaps between the mattress and side rails.
19
PATIENT OR FAMILY CONCERNS ABOUT BED RAIL USE
If patients or family ask about using bed rails, health care
providers should:
• Encourage patients or family to talk to their health care planning
team to determine whether or not bed rails are indicated.
• Reassure patients and their families that in many cases the
patient can sleep safely without bed rails.
• Reassess the need for using bed rails on a frequent, regular basis
.
To report an adverse event or medical device problem,
please call FDA’s MedWatch Reporting Program at
1-800-FDA-1088.
For additional information, visit the FDA’s website at:
http://www.fda.gov/medicaldevices

Proactive Medical Products
270 Washington Street
Mount Vernon, NY 10553
Tel: [phone]
www.proactivemedical.com