Parts and Accessories .................................................................................................................42
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Foreword
Thank you for purchasing Arjo equipment.
Please contact us if you have any questions
about the operation or maintenance of your
Arjo equipment.
Please read and fully understand these
Instructions for Use (IFU) before using Sara
Flex.
If a serious incident occurs in relation to this
medical device, affecting the user, or the patient
then the user or patient should report the serious
incident to the medical device manufacturer or the
distributor. In the European Union, the user should
also report the serious incident to the Competent
Authority in the member state where they are
located.
Information in this IFU is necessary to perform
the operation and maintenance of the equipment. It
will help to protect your product and make sure that
the equipment performs to your satisfaction. The
information in this IFU is important for the safety
of both patient and caregiver and must be read and
understood to help prevent possible injury.
8QDXWKRUL]HGPRGL¿FDWLRQVRQDQ\$UMRHTXLSPHQW
can affect safety. Arjo will not be held responsible
for any accidents, incidents or lack of performance
that occur as a result of any unauthorized
PRGL¿FDWLRQWRLWVSURGXFWV
Serious incident
Service and Support
Routine maintenance must be performed on Sara
Flex to maintain safety and reliability of the equipment. See section “Care and Preventive
Maintenance” on page 30.
If further information is needed, contact your local
Arjo representative for replacement parts. The
contact information appear on the last page of this
IFU.
'H¿QLWLRQVLQWKLVIFU
WARNING
Means: Safety warning. Failure to understand and
obey this warning may result in injury to you or to
others.
CAUTION
Means: Failure to follow these instructions may
cause damage to all or parts of the system or
equipment.
NOTE
Means: This is important information for the correct
use of this system or equipment.
If a serious incident occurs in relation to this
medical device, affecting the user, or the patient
then the user or patient should report the serious
incident to the medical device manufacturer or the
distributor. In the European Union, the user should
also report the serious incident to the Competent
Authority in the member state where they are
located.
Means: The name and address of the
manufacturer.
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Intended Use
This equipment must be used in
accordance with these safety instructions.
Anyone using this equipment must also
have read and understood the instructions
in these IFU.
If there is anything that remains unclear,
contact your Arjo representative.
Intended Use for Sara Flex
Sara Flex is a mobile standing and raising aid, with
a Safe Working Load of 200kg (440 lb), intended
to assist caregivers in hospitals, long-term care,
nursing homes and home care environments,
including private homes, to lift and transfer
patients/residents from one place to another e.g.
to and/or from a chair, wheelchair, bed side, bath,
shower/commode chair or toilet.
The equipment must be used by appropriately
trained caregivers with adequate knowledge of
the care environment, its common practice and
procedures and according to guidelines in this IFU.
Sara Flex should only be used for the purpose
VSHFL¿HGLQWKLVIFU. Any other use is prohibited.
Patient/Resident Assessment
In addition the patient/resident must
• be able to bear weight on at least one leg and
have some trunk stability
• be able to sit on the edge of the bed
• weigh in the range of 45 to 200 kg
(99 lb – 440 lb)
• have a height within the range of 145 to 195 cm
(4’8” – 6’4”).
If the patient does not meet these criteria an
alternative equipment/system shall be used.
CAUTION
To avoid product damage do not use Sara
Flex outdoors. The product is intended to
EHXVHGZLWKVSHFL¿FDOO\GHVLJQHGVOLQJV
Expected Service Life
The expected service life is the maximum period of
XVHIXOOLIHDVGH¿QHGE\WKHPDQXIDFWXUHU
The expected service life for Sara Flex is ten (10)
years considering the product has been serviced and
maintained as indicated in the Care and Preventive
Maintenance section.
Actual service life may vary depending on the
frequency of use and conditions.
It is recommended that facilities establish regular
assessment routines to make sure that caregivers are
assessing each patients/residents prior to use.
Before use the caregiver should always consider the
patients/residents medical condition, physical and
mental capabilities.
The IFU shall be available as long as reasonably
necessary, taking the lifetime of the device into
consideration.
Other consumable parts, e.g. batteries, sling, etc. are
also subject to wear and their expected operational
life is dependent on usage.
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Safety Instructions
WARNING
To avoid injury, make sure that the patient
is not left unattended at any time.
WARNING
This equipment includes small parts that
may present a choking hazard to small
children if inhaled or swallowed.
Keep children and pets away from the
equipment.
The hand control cable presents a
strangulation risk; take all precautions
necessary to prevent this.
WARNING
To avoid injury, a full clinical assessment
of the patient’s condition, and suitability
PXVWEHFDUULHGRXWE\TXDOL¿HG
personnel, before attempting to use
Sara Flex.
Policy on Number of Staff
Members Required for Patient
Transfer
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with one caregiver. It is the responsibility of the
caregiver to determine if a one or two person
transfer is more appropriate, based on the
following:
• patient’s condition
• the task
• patient’s weight
• environment
• capability
• skill level of the caregiver
Do not hesitate to contact your medical professional
for guidance.
WARNING
To avoid injury, make sure that the applied
load is lower than the safe working load
for all products or accessories being
used.
CAUTION
To avoid corrosion on the product do not
leave Sara Flex and its accessories for
extended periods in humid or wet areas.
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Preparations
Actions Before First Use (6 steps)
1. Visually check the package for damage. If the
product looks damaged due to freight, contact
the transport agency.
Do NOT use the product.
2. The packaging should be recycled according to
local regulations.
3. Read this IFU.
4. Choose a designated area, where this IFU
should be kept and is easily accessible at all
times.
5. Verify each functions (Up-Down, Open-Close
lift legs)
6. Initiate the emergency lowering function to
check it is working correctly. To do this, pull up
the red emergency lowering handle and keep it
pulled up, whilst at the same time, push down
on the lifting arm until it starts lowering.
Sara Flex Directions
Left and right
Sara Flex has a left and right side. (See Fig. 1)
Transfer direction
The caregiver must be positioned behind Sara Flex
during transfer.
Fig. 1
Transfer
direction
Left
Right
NOTE
Initial activation may require additional
amount of load on the lifting arm. It may be
helpful if two people perform this check, one
to activate the handle and the other to push
down the lift arm.
Actions Before Every Use (2 steps)
1. Visually inspect Sara Flex. If any part is
damaged - do NOT use the product.
2. Check the battery level.
In between Use
Clean and disinfect the product according to section
“Cleaning and Disinfection Instructions” on
page 27.
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Parts Designation
Maneuvering
Handle
Mast
Leg Strap
Attachment
Lifting Arm
Patient/Resident
Handle
Clip Attachment
Point
Leg Support
Leg Strap
Adjustable
Chassis Leg
Front Castor
Central Hook
(accessory)
Control Panel
Emergency
Lowering Handle
Motor/Actuator
Footplate
Hand Control
Emergency
Stop Button
Power Button
Battery
Rear
Castor
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Product Description / Functions
Controls and Features
Fig. 2
Hand control (See Fig. 2)
Use the hand control to:
• Raise/lower the lifting arm on Sara Flex.
• Open/close the chassis legs on Sara Flex.
• The dash buttons are used for menu operations.
Button Functions:
Up
Down
Close lift legs
Open lift legs
Right Dash
Fig. 3
Left Dash
If a pressed button is released, it will stop its function
immediately.
Control Panel (See Fig. 3)
The mast-mounted control panel operates in parallel
with the hand control. Sara Flex can also be controlled
from the mast.
Button Functions:
Up
Down
Close lift legs
Open lift legs
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LCD Display
0.0
kg
0.0
Fig. 4
(See Fig. 4)
Battery Level - see “Battery
Instructions” on page 25.
0.0
0.0
At start up it takes a little time before the display
looks as shown in Fig. 4. The LCD display will only
light up when a button is pressed.
Usage counter
The usage counter shows the total added amount of
time (in hours) that the lift’s lifting arm has been
raised or lowered.
The usage counter will increase in increments of 0.1
hours whenever an additional six minutes have been
added.
Usage counter
Maintenance symbol
Patient’s weight - see “Scale (Optional)” on page 20.
Fig. 5
NOTE
The usage counter only records during
movement of the lifting arm.
Maintenance symbol
The maintenance symbol is a reminder for the yearly
maintenance requirements for the product.
The maintenance symbol is shown after a 125 hours
of usage. This is the average time a lift is used during
When the maintenance symbol appears, the unit will
still be safe to use, but the yearly maintenance should
be performed as soon as possible.
NOTE
The technician must reset the display to ‘’0.0’’
hours when the annual inspection is performed.
This is done to visually see when next
inspection is due.
A
B
Castor Brakes
The rear castors brakes are foot operated to keep Sara
Flex in position.
Apply the brakes (See Fig. 5):
Press down on the gray castor brake lever (A).
Release the brakes (See Fig. 5):
Slightly kick up the gray castor brake lever (B).
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Fig. 6
Emergency Stop Button
Fig. 7
A
A
B
To Activate
Press the red emergency stop button (A) to cut all
power to all electrical components. (See Fig. 6)
To Deactivate
Press the green power button (B) to power on the
equipment again. (See Fig. 6)
Power Button
The green power button (B) is located next to the stop
button. Press the power button to switch on Sara Flex.
(See Fig. 6)
Leg Support
The leg support is made out of silicone. (See Fig. 7)
This material adjusts itself based on the pressure
applied by the patient knees (A).
Fig. 8
Leg Strap
The leg strap is located under the silicone leg support.
(See Fig. 8)
The leg strap is used to make sure that the patient’s
legs stay close to the leg support.
To fasten the leg strap attach it to the attachment point
on either side of the leg support.
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Fig. 9
Fig. 10
Leg Strap attachment (optional)
Insert strap from the leg strap attachment.
(See Fig. 9)
Fasten strap to the leg pad support.
Fig. 11
(See Fig. 10)
Repeat on the other side, if needed.
(See Fig. 11)
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Fig. 12
Emergency Lowering
In the event that the emergency lowering function
needs to be activated, position the Sara Flex so that
the patient can be lowered on to an appropriate
surface such as a chair or bed. Stand near of the Sara
Flex, on the same side as the red emergency lowering
handle. (See Fig. 12)
Fig. 13
Use one hand to gradually pull up the emergency
lowering handle (and keep it there) allowing the
lifting arm to lower the patient onto the surface. Once
lowered, let go of the emergency lowering handle and
it will return to its correct position. (See Fig. 13)
NOTE
If the lifting arm does not start to lower when
the emergency lowering handle is pulled up,
use your other hand to push down on the lifting
arm whilst still pulling up on the emergency
lowering handle, until the lifting arm begins to
lower. (If the lifting arm is in the fully upright
position, it may help to stand facing the patient
and push the lifting arm away from you). Keep
the emergency lowering handle pulled up fully
until the patient is lowered on to the receiving
surface.
Automatic Cut-Out
This is not an operator control but a function built into
the Sara Flex electronics.
If the lift is inadvertently overloaded by trying to raise
or lower a load heavier than permitted, an automatic
“cut-out” function operates to prevent the lift from
raising a weight in excess of the safe working load
(SWL). This will stop the lift’s motion automatically.
If this occurs, release the “up” button on the
hand control or the control panel. Do not continue to
raise the load. Make sure that the Sara Flex operates
only within its safe working load.
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Anti-Crush System
This is not an operator control but a function built into
the Sara Flex electronics.
Great care should be taken not to lower the lifting
arm onto the patient or any other obstruction. If this
should happen, the Sara Flex “anti-crush” system will
engage, stop the motor and all downward movement
will cease. If this occurs, release the “down” button
immediately and press the “up” button to raise the
lifting arm until the lift is clear.
Then remove the obstruction.
Allowed Slings with Sara Flex
Fig. 14
Fig. 15
The following slings are compatible with Sara Flex.
Active Slings (See Fig. 14)
• TSS.500 (S)
• TSS.501 (M)
• TSS.502 (L)
• TSS.503 (XL)
• TSS.504 (XXL)
Flites
• MFA3000 (Flite)
Transfer Sling (See Fig. 15)
• TSS.511 (Transfer Sling Model, only to be used
with Central Hook)
For sling selections see respective sling IFU.
Fig. 16
Central Hook (Accessory)
Only to be used with the transfer sling. The central
hook (See Fig. 16) is to be installed right under the
OLIWLQJDUPE\TXDOL¿HGSHUVRQQHORQO\
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Transfer from Wheelchair to Sara Flex
Prepare Sara Flex and Patient
• For sling instructions, see respective sling IFU and the sling label.
• Determine if Sara Flex is the appropriate equipment to use for the patient,
see “Intended Use” on page 5.
• Lower the Sara Flex lifting arm to its lowest position.
• Inform the patient about the transfer (e.g. transfer to bathroom).
• Select and apply sling, see respective sling IFU.
• Apply brakes to the wheelchair (if applicable).
Place Patient in Sara Flex
(8 Steps)
1. Open chassis legs if needed to accommodate the
width of the chair, bed, etc.
NOTE
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furniture, do not open the chassis legs
Fig. 17
Fig. 18
2. Ask or assist the patient to place his/her feet on
the foot plate. (See Fig. 17)
3. Push Sara Flex towards the patient until it gently
touches the patient’s shins. (See Fig. 18)
Fig. 19
4. Ask or assist patient to place his/her hands on the
patient/resident handles.(See Fig. 19)
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Fig. 20
Fig. 21
Fig. 22
Fig. 23
5. Attach sling clips to attachment points on the Sara
Flex lifting arm. (See Fig. 20)
6. Make sure the clips are attached securely.
(See Fig. 21)
7. When using a transfer sling, also attach the loops
on the central hook (accessory) located right
under the lifting arm. (See Fig. 22)
8. Attach the leg strap to support the patient’s legs, if
needed. (See Fig. 23)
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Fig. 24
Raise a Patient to Standing Position
NOTE
• When raising the patient with transfer sling,
he/she should not help out while being
raised.
• When using the transfer sling, do not raise
the patient higher than seating position. A
higher position will not be comfortable for
the patient.
(5 Steps)
1. Stand next to the patient and inform him/her
that the Sara Flex will be raised to a standing
position.
2. Check attachment points to make sure the Sara Flex is ready.
WARNING
To avoid injury make sure the patient is
participating. If not, consider to end the
transfer, return the patient to a sitting
position and reevaluate the choice of
equipment.
Fig. 25
3. Use the hand control to raise patient from sitting
position to standing position. (See Fig. 24)
4. While the patient is standing, check the supports.
5. Tighten safety straps around the abdomen, if
needed.
Patient Transfer
(2 Steps) (See Fig. 25)
1. Pull Sara Flex away from the wheelchair, using
the maneuvering handle.
2. Close the chassis legs if needed.
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Transfer from Sara Flex to Toilet
(18 Steps)
1. Using the maneuvering handle, position patient in
Fig. 26
Fig. 27
front of the toilet/commode or device that patient
will sit on. (See Fig. 26)
2. Adjust chassis legs if needed.
3. While the patient is standing caregiver can
help with the patient’s clothing (i.e., dressing,
undressing or toileting tasks etc.).
4. Position the patient over the toilet/commode.
Press the down arrow on the hand control to lower
the patient to a sitting position.
5. Stand next to the patient while he/she is being
lowered.
WARNING
To avoid pinching of genitals and skin,
make sure there is enough clearance
during movement .
6. Apply the castor brakes to keep Sara Flex in
position once the patient is sitting on the toilet.
(See Fig. 27)
7. Remove sling clips from Sara Flex.
8. Have the patient release their hands from the
patient/resident handles.
9. Detach leg straps, if applicable.
10. Remove sling, if needed.
11. Allow privacy for the patient, but make sure the
patient is not left unattended.
12. After providing personal hygiene care, reapply
sling, if removed.
13. Ask or assist patient to place his/her hands on the
patient/resident handles.(See Fig. 19)
14. Attach sling clips to attachment points on the Sara
Flex lifting arm. (See Fig. 20)
15. Make sure the clips are attached securely.
(See Fig. 21)
16. Raise the patient slightly and apply any necessary
incontinent products and adjust clothing.
17. Release the brakes.
18. Before transfer from the toilet, repeat the steps
in “Raise a Patient to Standing Position” on
page 17.
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Transfer from Sara Flex to Bed/Chair
(11 Steps)
Fig. 28
Fig. 29
1. Apply the brakes on the wheelchair, if applicable.
2. Adjust chassis legs if needed to go around bed/
chair. (See Fig. 28)
3. Lower the patient onto the surface of bed/chair.
(See Fig. 29)
4. Make sure the patient is positioned correctly on
the bed/chair.
5. Detach the sling from Sara Flex.
6. Have the patient release their hands from patient/
resident handles.
7. Detach leg straps, if applicable.
8. Have the patient lift his/her feet off the footplate,
assist if needed.
9. Pull the Sara Flex away from the patient.
10. Remove the sling from the patient
11. Clean the Sara Flex after the transfer is complete,
according to “Cleaning and Disinfection Instructions” on page 27 or according to local
guidelines.
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Scale (Optional)
WARNING
To avoid injury, only use the scale to weigh
hospital or care facility patients under the
supervision of Nursing staff and healthcare
professionals.
CAUTION
7KHXQLWPXVWEHVWDWLRQDU\RQDÀDWOHYHO
surface when it is powered up, to allow the
scale to perform an automatic zero reset.
Do not touch the lift or any of its
components until the scale displays “0.0”.
Failure to do so may result in inaccurate
reading of the weight on the scale.
The minus sign (-) appears when the weight is
negative (see “Method B - Weigh Patient with Sling” on page 23”).
Overload Warning Symbol
The maximum weight warning symbol appears when
the patient weight exceeds the Safe Working Load
(SWL) 200 kg (440 lb). (See Fig. 30)
If the scale is overloaded, the unit will beep 2
times and the display will switch between the scale
symbol and the maximum weight warning symbol.
Remove the overload weight by lowering the patient
immediately.
Do not touch the scale/lift until the symbol is switched
off.
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0.0
kg
Fig. 31
144.0
kg
NET
Net weight
Fig. 32
NET
This is the Net weight of the patient without any
accessories e.g. sling. (See Fig. 31)
For instruction on how to get the Net weight of the
patient, see “Method A - Weigh the Patient without
Sling Weight” on page 22
Save weight
To use the Save function, press the left dash button
(A), to store the weight on the scale. (See Fig. 32)
B
A
This will save the displayed measurement on the
screen. Two blue lines will be displayed when the
displayed measurement is saved (B).
NOTE
Patient should be as still as possible during the
weighing procedure. Too much movement by
the patient may cause an incorrect reading
Fig. 33
Scale SymbolTilt Symbol
Tilt (for class III scale only)
The display will switch between the scale symbol
with a tilted symbol.
NOTE
FOR CLASS III SCALE ONLY,
If the display shows the larger “TILT” symbol
alternating with the scale symbol, relocate Sara Flex to a level position so that the scale can be
operated correctly (See Fig. 29).
When the Sara Flex is tilted, no weight reading will
be available.
It is normal that the display occasionally shows
a “Tilt” symbol when the lift is being moved or
touched.
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Using the Scale - Weigh the Patient
0.0
kg
0.0
144.0
kg
NET
0.0
kg
Method A - Weigh the Patient without
Fig. 34
Fig. 35
NET
A
Fig. 36
Sling Weight
(8 Steps)
1. Use the power button to power on the Sara Flex.
2. If the sling is already installed on the Sara Flex it
has already zeroed the scale weight automatically.
(See Fig. 34)
Move ahead to step 5.
3. If the sling isn’t already installed on the lift,
install the sling. The scale will now show the
weight of the sling on the screen.
4. To use the Scale function, press the right dash
button (A) to zero the scale. Now the display
will show a zero weight with a NET symbol.
(See Fig. 35)
5. Apply the sling on the patient, see respective
Sling IFU. Place the patient safely onto Sara Flex.
Fig. 37
A
6. Lift the patient. (See Fig. 36)
7. The net weight of the patient is now displayed.
(See Fig. 37)
8. Press the left dash button (A) to keep the Net
weight text on the display.
NOTE
When the Sara Flex goes into sleep
mode the weight text on the display will
disappear.
22
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Method B - Weigh Patient with Sling
0.0
kg
-144.0
kg
Fig. 38
Fig. 39
(7 Steps)
NET
NET
A
1. Raise the patient to a standing position.
2. Press the right dash button to obtain a zero
reading on the display. (See Fig. 38)
3. Complete the patient transfer and remove him/her
from the Sara Flex.
4. The scale will display a negative number.
5. Attach the sling back on Sara Flex.
6. Ignore the minus sign on the screen. Allow the
weight reading to stabilize. The weight shown is
the patient’s actual weight. (See Fig. 39)
7. Press the left dash button (A) to save the net
weight text on the display.
NOTE
When the Sara Flex goes into sleep mode
the weight text on the display will disappear.
23
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Fig. 40
Fig. 41
Changing the Units of Measure
(6 Steps)
1. To display the Lift Status Screen, press both dash
buttons (A) at the same time. (See Fig. 40)
A
B
C
2. 7RDFFHVVWKHFRQ¿JXUDWLRQVFUHHQSUHVVWKHGRZQ
button (B) on the hand control. (See Fig. 40)
The Weight Unit screen will be displayed.
(See Fig. 41)
Fig. 42
kg
3. Press the right dash button (C) to access the units
of measurement option. (See Fig. 42)
4. To switch between kg and lb, press the down
button (B).
5. To save the settings and return to normal use,
CD
press the right dash button (C). (See Fig. 42)
6. Press the left dash button (D) to exit without
saving changes. (See Fig. 42)
NOTE
It is not possible to change the units of
mass on the Class III scale.
24
Page 25
Battery Instructions
WARNING
To avoid bodily injury, do NOT crush,
puncture, open, dismantle or otherwise
mechanically interfere with the battery.
• Should the battery casing crack and
cause contents to come in contact with
skin or clothing, rinse immediately
with plenty of water.
• If contents come in contact with the
eyes, rinse immediately with plenty of
water and seek medical attention.
• Inhalation of the contents can cause
respiratory irritation. Seek fresh air
and medical attention.
CAUTION
To avoid the battery from overheating
and exploding, do NOT expose the
EDWWHU\WRÀDPHVRUH[FHVVLYHKHDW
Sara Flex uses sealed lead-acid batteries mounted
below the control panel. The LCD screen only
shuts down after 2 minutes of inactivity. The rest
of the electronics shuts down after 10 minutes of
inactivity, to prevent battery damage or drainage
while the lift is in the stand-by mode.
If the battery is close to being empty, the unit
will beep 3 times and only a large red low battery
indicator will show on the display, then the lift will
go into sleep mode.
When trying to use the lift with an almost empty
battery:
• The lift will not be operable until the battery is
recharged or replaced.
Storage of Battery
• The battery is delivered charged but it’s
recommend to recharge the battery when
received, due to a slow discharge.
• The battery will slowly discharge when not
used.
• A battery not in use should be stored in a
temperature range of
-0°C (32°F) to + 30°C (86°F).
• For maximum battery performance do not store
the battery above 50°C (122°F).
Low Battery Warning
Sara Flex has a battery charge indicator on the
hand control. (See Fig. 43)
Fig. 43
0.0
Battery Charge
Indicator
The battery indicator on the hand control will
show if the batteries for Sara Flex are close to
being empty and it will beep two times every
minute. Complete the transfer and charge the
battery.
0.0
kg
Low battery indicator
(10% charge remaining)
Charging Intervals
• To prolong the life of the battery, charge it at
regular intervals, e.g. every night.
• It is recommended to use two batteries, one in
operation and one as a stand-by in the charger.
• It is recommended that the battery not in
use is left in the charger. There is no risk of
overcharging the battery.
• It is recommended to remove the battery from
the Sara Flex when it is not to be used for an
extended period of time.
• To prolong the life of the battery, recharge it
before it reaches a low level charge.
25
Page 26
,QVHUWLQJ5HPRYLQJWKH%DWWHU\
7KHVDPHPHWKRGDSSOLHVIRULQVHUWLQJUHPRYLQJ
the battery on the Sara Flex or the charger.
Fig. 44
Fig. 45
Fig. 46
Inserting the Battery (2 Steps)
1. Place the battery in the battery rack.
(See Fig. 44)
2. Push the top of the battery until it is in
position. (See Fig. 45)
Removing the Battery (3 steps)
1. Push the release button. (See Fig. 46)
2. Pull the battery out. (See Fig. 45)
3. Lift the battery to detach it from the battery
rack. (See Fig. 44)
Battery Service Life
The battery life is around 2-5 years and is affected
by charging practices and load exertion.
Installation of Charger
See respective Battery Charger IFU.
How to Charge the Battery
See respective Battery Charger IFU.
26
Page 27
Cleaning and Disinfection Instructions
The following processes are recommended, but
should be adapted to comply with the local or
national guidelines (Decontamination of Medical
Devices) which may apply within the Healthcare
Facility or the country of use. If uncertain, seek
advice from the local Infection Control Specialist.
Sara Flex should be routinely cleaned and
disinfected between patients and at regular intervals
while in use; as is good practice for all reusable
medical devices.
If there are any questions regarding cleaning
and disinfecting the equipment, or wish to order
See section, Parts and Accessories. Make sure to
have the Safety Data Sheets (SDS) available for the
disinfectants being used.
WARNING
Detergents/Disinfectants
• Mild neutral detergent
• Alcohol (Ethyl or Isopropyl) 70-90%
• Chlorine (10 000ppm free chlorine)
• Phenols (as per Manufacturer’s
Recommendation)
• Quaternary Ammonium (as per Manufacturer’s
Recommendation)
• Hydrogen Peroxide (<4.5%) can be used, but
may cause discoloration on the Sara Flex.
Accessories Needed for Cleaning/
Disinfection
• Protective glasses
• Protective gloves
• Spray bottle with water
• Disposable towels
• Brush
To avoid eye and skin damage, always
use protective glasses and gloves. If
contact occurs, rinse with plenty of water.
If eyes or skin becomes irritated, contact
a physician. Always read the instructions
for use and material safety data sheet of
the disinfectant.
WARNING
To prevent cross-contamination, always
follow the disinfection instructions in this
Instructions for Use.
WARNING
To avoid eye or skin irritation, never
disinfect in the presence of
a patient.
27
Page 28
Cleaning/Disinfection
Follow this procedure between every use.
Follow these 14 steps
Preparation (step 1)
1. Place Sara Flex in an ergonomic working
position.
Removal of visible contamination (step 2-3)
2. Wet a disposable towel with water and remove
visible stains and soil on Sara Flex.
3. If heavily contaminated, please use brush and
towels to remove all visible contamination.
Fig. 47
A
B
C
Cleaning (step 4-8)
4. 6SUD\ZLWK$UMRYHUL¿HGGHWHUJHQWVHH“Detergents/Disinfectants” on page 27 on all
parts of Sara Flex and on the hand control.
5. Wet a disposable towel with water and remove
all traces of the detergent. For the leg support
(A) and leg strap (B), use a disposable towel to
remove the detergent and for the footplate (C),
you may need a brush. (See Fig. 47)
6. If the detergent cannot be removed, spray water
on the affected part and then wipe it off with
disposable towels.
7. Repeat until all of the detergent has been
removed.
8. Let all parts dry.
Disinfection (step 9-14)
9. 5HSHDWVSUD\LQJZLWKWKH$UMRYHUL¿HG
disinfectant on all parts and on the hand control.
10. Allow the disinfectant to stay on the parts
according to manufacturer’s recommendation.
11. Remove all traces of disinfectant, using new wet
disposable towels. For the leg support (A) and leg
strap (B), use a disposable towel to remove the
disinfectant and for the footplate (C), you may
need a brush. (See Fig. 47)
12. If the disinfectant cannot be removed, spray with
water on the affected part and wipe it off with
disposable towels.
13. Repeat until all of the disinfectant has been
removed.
14. Let all parts dry.
28
Page 29
Troubleshooting
Problem DescriptionSolution
Hand control does not respond• Check that the Emergency stop button on the control
box is not pushed.
• Check the connector on hand control cord.
• Check the battery condition (replace with a fully
charged battery pack).
UP and DOWN buttons on control box
do not respond
The control box beeps two times
every 30 seconds and the red empty
battery icon will show in the upper left
corner of the display
The control box beeps three times
and only a large red low battery
indicator will show on the display and
then the lift shuts-off.
The control box beeps more than
three times in conditions other than
those mentioned above.
Actuators “stalls” during operationBattery is low. Replace with a freshly charged battery.
• Check that the Emergency stop button on the control
box is not pushed.
• Check the battery condition (replace with a fully
charged battery pack).
Battery is low. Replace with a freshly charged battery
pack.
Battery is low. Replace with a freshly charged battery
pack.
Call Arjo for service.
Do not exceed the lifting capacity.
29
Page 30
Care and Preventive Maintenance
Sara FlexLVVXEMHFWWRZHDUDQGWHDUDQGWKHIROORZLQJDFWLRQVPXVWEHSHUIRUPHGZKHQVSHFL¿HGWR
PDNHVXUHWKDWWKHSURGXFWUHPDLQVZLWKLQLWVRULJLQDOPDQXIDFWXULQJVSHFL¿FDWLRQ
WARNING
To avoid malfunction resulting in injury, make sure to conduct regular inspections and
follow the recommended maintenance schedule. In some cases, due to heavy use of the
product and exposure to aggressive environment, more frequent inspections should be
carried out.
Local regulations and standards may be more stringent than the recommended
maintenance schedule.
WARNING
To avoid injury to both the patient and the caregiver, never modify the equipment or use
incompatible parts.
SCHEDULE
Caregiver Obligations Action/Check
Cleaning/Disinfection x
Examine the sling, straps and clips for damage or fraying as
required.
Check to make sure the patient/resident handles are secure. x
Visually check exposed surfaces for damage, sharp edges,
etc.
Visually check sling attachment points. Do not use if
damaged.
Make sure all labels are attached. x
Visually check the hand control and cable for damage. x
Perform a full functionality test on Sara Flex.x
Check operation of the Emergency Stop/Power Button and
the Emergency Lowering Handle
Check battery for leakage and/or deterioration. Replace if
needed.
• Sara Flex has to be cleaned and disinfected
immediately after usage
• For further disinfecting instructions, see section
“Cleaning and Disinfection Instructions” on
page 27.
Examine the sling, strap and clips for
damage or fraying as required
• See respective sling IFU .
Fig. 48
D
C
B
A
Check to make sure the patient/resident
handles are secure
• Grab the patient/resident handles (D)
¿UPO\URWDWHWKHPDQGSXVKWKHPRXWZDUG
(See Fig. 48)
Every Week
Visually check exposed surfaces for damage,
sharp edges, etc.
• Pay close attention to all the parts that are in
contact with the patient: foot plate (A), leg strap
(B), leg support (C), patient/resident handles
(D). (See Fig. 48)
• Look for tears in the leg support and leg strap.
• Look for any deformation in structural parts.
Visually check sling attachment points.
Do not use if damaged
• Check the slings for fraying, cuts or loose
stitching.
31
Page 32
Make sure all labels are attached
• Check if all labels are attached on the Sara
Flex according to “Labels on Sara Flex” on
page 37.
Visually check the hand control and cable for
damage
• Check the hand control screen for dead pixels
or any other display defects.
Fig. 49
Fig. 50
Perform a full functionality test on Sara Flex
• Raise the lifting arm to its highest position
using the hand control or the control panel.
• Lower the lifting arm to its lowest position
using the hand control or the control panel.
• Test every button on the hand control and the
control panel. (See Fig. 49)
All buttons must be working according to
“Controls and Features” on page 9.
• Move the Sara FlexDURXQGRQDÀDWVXUIDFHDQG
make sure that the four castors are in contact
with the ground.
• Make sure to test the brakes. Activate the brakes
and try to move the Sara Flex around.
• Check for abnormal sounds during movements.
Check operation of the Emergency Stop/
Power Button and the Emergency Lowering
Handle
Fig. 51
• Raise the lifting arm.
• Push the lifting arm down while pulling up the
Emergency Lowering handle. The lifting arm
should lower slowly. (See Fig. 50)
• While raising/lowering the lifting arm or
opening/closing the legs, press the Emergency
Stop/Power Button (A). The lift movement
should stop immediately. (See Fig. 51)
A
32
Page 33
Check battery for leakage and/or
deterioration. Replace if needed
• Remove the battery.
• Check the battery connector for any damage.
• Visually inspect the battery and look for leakage
and/or deterioration.
Check all castors for wear
• Clean the castors with water (their functionality
can be affected by soap, hair, dust and
FKHPLFDOVIURPÀRRUFOHDQLQJ
• Check that the castors are rolling and swiveling
freely.
Check for evidence of corrosion
If there is any visible corrosion or damage on parts,
contact your local Arjo representative for support.
<HDUO\&KHFNVE\4XDOL¿HG
Personnel only
Sara Flex must be serviced once a year in accordance
with the Maintenance and Repair Manual.
WARNING
To avoid injury and/or unsafe product, the
maintenance activities must be carried
RXWDWWKHFRUUHFWIUHTXHQF\E\TXDOL¿HG
personnel using correct tools, parts
DQGNQRZOHGJHRISURFHGXUHV4XDOL¿HG
personnel must have documented training
in maintenance of this device.
NOTE
All Caregiver Obligations are to be checked
ZKHQSHUIRUPLQJWKH4XDOL¿HG3HUVRQQHO
Service.
For details, see separate service instructions.
33
Page 34
7HFKQLFDO6SHFL¿FDWLRQV
General
Safe working load (SWL)
Sara Flex200 kg / 440 lb
Component Weight
Sara Flex complete52 kg / 114.5 lb
Battery Pack3.8 kg / 8.4 lb
Electrical
Degree of protection - Electrical Shock
Type BF
Lift - Protection ClassIP24
Hand Control - Protection ClassIPX7
Battery TypeRechargeable - sealed lead acid
Battery Part NumberNDA0100-20
Battery capacity24V DC 4Ah
Battery ChargerNDA8200
Lift - Protection Class - shock protectionInternally powered equipment
Lift nominal voltage24V DC
Fuse15A type AGC fuse
Operating force of controls< 5 N
Max Duty Cycle, Lift Actuator
Max Duty Cycle, Leg Spread Actuator
Maximum sound power level50dB
10% MAX (2 min ON / 18 min OFF)
10% MAX (2 min ON / 18 min OFF)
6FDOHVSHFL¿FDWLRQ
Weight range200 kg / 440 lb
Display resolution and type0.2 kg / 0.5 lb, liquid crystal display
Operating conditions
Ambient temperature+10°C (50°F) to +40°C (104°F)
Relative humidity range10% to 80%
Atmospheric Pressure700 hPa to 1060 hPa
Transport and Storage
Ambient temperature-25°C (-13°F) to +70°C (158°F)
Relative humidity range10% to 80%
Atmospheric Pressure700 hPa to 1060 hPa
When transporting the product from one facility to another, make sure the product is properly
secured.
34
Page 35
Safe Disposal
Battery
PackageWood and corrugated cardboard, recyclable.
Product
Electrical and electronic
componants
Slings
Lead-Acid
Not for disposal. Environmental danger.
Electric, Metal and Plastic Parts shall be separated and recycled
according to marking on the unit.
Lift systems having electrical and electronic components or an
electrical cord should be disassembled and recycled per Waste of
Electrical and Electronic Equipment (WEEE) or in accordance with
local or national regulation.
Slings including stiffeners/ stabilizers, padding material, any other
textiles or polymers or plastic materials etc. should be sorted as
combustible waste.
Allowed Combinations
• TSS.500 (S)
• TSS.501 (M)
Active Sling
• TSS.502 (L)
• TSS.503 (XL)
• TSS.504 (XXL)
Transfer Sling• TSS.511 (Only to be used with Central Hook)
performance and
requirements, e.g. Input
Power, Input Voltage and
maximum patient Weight
etc.
,GHQWL¿FDWLRQ
Label
States the product
LGHQWL¿FDWLRQVHULDO
number and year and
month of manufacturing.
SWL LabelThis label indicates the
maximum lifting capacity of
Sara Flex
Battery LabelStates safety and
environmental information
for the battery.
Weighing
Parameters
Scale Label
This label states the
weighing parameters for
the scale.
Symbol explanation
SWLSafe Working Load
'H¿QHVWKHPD[LPXPWRWDO
load of patient or any other
load that may be on Sara Flex
IP24
Degree of protection against
splashing water
24 V
10 A
Supply voltage (DC)
Current
+
Max
Min
SWL
Type BF protection against
electrical shock in accordance
with IEC 60601-1
CE marking in accordance
with The Medical Devices
Directive 93/42/EEC.
&HUWL¿HGDFFRUGLQJWR157/
through TÜV SÜD. See
section, List of Standards and
&HUWL¿FDWHV
&HUWL¿HGWKURXJK7h96h'
See section, List of Standards
DQG&HUWL¿FDWHV
Total mass of equipment
kg / lb
=
including its safe working load
(52kg/116lb+200kg/440lb
=252kg / 556lb).
SWL Rating
Indicates the maximum lifting
capacity of the lift.
Scale symbol.
If the lift has this symbol, the
scale function is installed.
Maximum capacity of the
weighing instrument
Minimum capacity of the
weighing instrument
e
9HUL¿FDWLRQVFDOHLQWHUYDO
Waste Electrical and
Electronic Equipment (WEEE)
- do not dispose of this
product in general household
or commercial waste.
Model number
Serial number
Manufacturer name and
address
37
Cat:
Do not push or pull on the
actuator
Non-automatic weighing
III
M
yy
instrument label Class III;
XXXX
\\ \HDU;;;; 1RWL¿HG
Body Number.
Indicates the product is a
Medical Device according
to EU Medical Device
Regulation 2017/745
Page 38
Scale symbol label
Scale Class III
data label
LINAK symbol label
SWL Label
,GHQWL¿FDWLRQODEHO
Data label
(on the mast behind the battery)
Weighing
parameters scale
label
Battery label
(Behind battery)
38
Page 39
/LVWRI6WDQGDUGVDQG&HUWL¿FDWHV
STANDARDS/
CERTIFICATE
EN/IEC 60601-1
(TÜV SÜD)
EN ISO 10535: 2006
(TÜV SÜD)
BS EN 45501:2015Metrological aspects of non-automatic weighing instruments.
OIML R 76-1:2006
DESCRIPTION
Medical electrical equipment
Hoists for the transfer of disabled persons
- Requirements and test methods.
Non-automatic weighing instruments Part1: Metrological and
technical requirements.
39
Page 40
Electromagnetic Compatibility
Sara Flex has been tested for compliance with current regulatory standards regarding its capacity to block
EMI (electromagnetic interference) from external sources. Nonetheless, some procedures can help reduce
electromagnetic interferences:
• Ensure that other devices in patient-monitoring and/or life-support areas comply to accepted
emissions standards.
• Maximize the distance between electro-medical devices. High-powered devices may produce EMI
that can affect the lift.
For more information on how to manage the unit’s RF electromagnetic environment, please consult
the AMI TIR 18-1997 - Guidance on Electromagnetic Compatibility of Medical Devices for Clinical/
Biomedical Engineers.
Sara Flex LVLQWHQGHGIRUWKHXVHLQWKHHOHFWURPDJQHWLFHQYLURQPHQWVSHFL¿HGEHORZ7KHFXVWRPHURUWKHuser of Sara Flex should assure that it is used in such an environment.
WARNING
Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm to any part of the
Arjo could result in increased electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation.
WARNING
Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment
and the other equipment should be observed to verify that they are operating normally.
WARNING
The equipment may cause radio interference or may disrupt the operation of nearby
equipment. It may be necessary to take action, such as reorienting, relocating the
equipment or shielding the location.
Guidance and manufacturer’s declaration: electromagnetic emissions
Group 1Sara Flex uses RF energy only for its internal function. Therefore,
its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
Class BSara Flex is suitable for use in all establishments, including
domestic establishments and those directly connected to the public
low voltage power supply network that supplies buildings used for
domestic purposes.
40
Page 41
Guidance and manufacturer’s declaration: electromagnetic immunity
Immunity testIEC60601 test levelCompliance levelElectromagnetic environment
- guidance
Floors should be wood,
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8kV contact
±15kV air
±8kV contact
±15kV air
concrete or ceramic tile.
,IÀRRUVDUHFRYHUHGZLWK
synthetic material the relative
humidity level should be at
least 30%
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
Electrical fast
transient/burst
IEC 61000-4-4
Power frequency
(50/60 Hz)
0DJQHWLF¿HOG
IEC 61000-4-8
3 V outside ISM bands
between
0.15-80 MHz
6 V inside ISM and
amateur radio bands
between 0.15 - 80 MHz
10V/m
80MHz to 2.7GHz
±1 kV, I/O Ports
100 kHz repetition
frequency
30 A/m
50/60 Hz
3 V outside ISM bands
between
0.15-80 MHz
6 V inside ISM and
amateur radio bands
between 0.15 - 80 MHz
10V/m
80MHz to 2.7GHz
±1 kV, I/O Ports
100 kHz repetition
frequency
30 A/m
50/60 Hz
N/A
Mains power supply
should be that of a typical
commercial or hospital
environment.
If functional disturbance
occurs on Sara Flex it may
be necessary to install
magnetic shielding. The
power frequency magnetic
¿HOGVKRXOGEHPHDVXUHG
prior to installation to assure
WKDWLWLVVXI¿FLHQWO\ORZ
3UR[LPLW\¿HOGV
from RF wireless
communications
equipment
IEC 61000-4-3
380 - 390 MHz
27 V/m; PM 50%; 18 Hz
430 - 470 MHz
28 V/m; (FM ±5 kHz, 1
kHz sine) PM; 18 Hz
704 - 708 MHz
9 V/m; PM 50%; 217 Hz
800 - 960 MHz
28 V/m; PM 50%; 18 Hz
1700 - 1990 MHz
28 V/m; PM 50%; 217 Hz
2400 - 2570 MHz
28 V/m; PM 50%; 217 Hz
5100 - 5800 MHz
9 V/m; PM 50%; 217 Hz
380 - 390 MHz
27 V/m; PM 50%; 18 Hz
430 - 470 MHz
28 V/m; (FM ±5 kHz, 1
kHz sine) PM; 18 Hz
704 - 708 MHz
9 V/m; PM 50%; 217 Hz
800 - 960 MHz
28 V/m; PM 50%; 18 Hz
1700 - 1990 MHz
28 V/m; PM 50%; 217 Hz
2400 - 2570 MHz
28 V/m; PM 50%; 217 Hz
5100 - 5800 MHz
9 V/m; PM 50%; 217 Hz
N/A
41
Page 42
Parts and Accessories
Central Hook
700-27041
Leg Strap
AH1003006
Disinfectant
To order, contact local representative
Battery
NDA0100-20
Leg Strap Attachment
700-27044
Battery Charger
NDA8200
42
Page 43
AUSTRALIA
Arjo Australia
Building B, Level 3
11 Talavera Road
Macquarie Park, NSW, 2113,
Australia
Phone: 1800 072 040
HONG KONG
Arjo Hong Kong Limited
Room 411-414, 4/F, Manhattan Centre,
8 Kwai Cheong Road, Kwai Chung, N.T.,
HONG KONG
Tel: +852 2960 7600
Fax: +852 2960 1711
ITALIA
Arjo Italia S.p.A.
Via Giacomo Peroni 400-402
IT-00131 ROMA
Tel: +39 (0) 6 87426211
Fax: +39 (0) 6 87426222
E-mail: Italy.promo@arjo.com
MIDDLE EAST
Arjo Middle East FZ-LLC
Of¿ ce 908, 9th Floor,
HQ Building,North Tower,
Dubai Science Park,
Al Barsha South
P.O Box 11488, Dubai,
United Arab Emirates
Direct +971 487 48053
Fax +971 487 48072
Email: Info.ME@arjo.com
NEDERLAND
Arjo BV
Biezenwei 21
4004 MB TIEL
Postbus 6116
4000 HC TIEL
Tel: +31 (0) 344 64 08 00
Fax: +31 (0) 344 64 08 85
E-mail: info.nl@arjo.com
SUOMI
Arjo Scandinavia AB
Riihitontuntie 7 C
02200 Espoo
Finland
Puh: +358 9 6824 1260
E-mail: Asiakaspalvelu.¿ nland@arjo.com
SVERIGE
Arjo International HQ
Hans Michelsensgatan 10
SE-211 20 MALMÖ
Tel: +46 (0) 10 494 7760
Fax: +46 (0) 10 494 7761
E-mail: kundservice@arjo.com
UNITED KINGDOM
Arjo UK and Ireland
Houghton Hall Park
Houghton Regis
UK-DUNSTABLE LU5 5XF
Tel: +44 (0) 1582 745 700
Fax: +44 (0) 1582 745 745
E-mail: sales.admin@arjo.com
USA
Arjo Inc.
2349 W Lake Street Suite 250
US-Addison, IL 60101
Tel: +1 630 307 2756
Free: +1 80 0 323 1245 Institutional
Free: +1 800 868 0441 Home Care
Fax: +1 630 307 6195
E-mail: us.info@arjo.com