Arjo Sara Flex User manual

Sara Flex
INSTRUCTIONS FOR USE
04.KL.00.EN_5 · 05/2020

2
WARNING
To avoid injury, always read this Instructions for Use and accompanied documents
before using the product.
Mandatory to read the Instructions for Use.
Design Policy and Copyright
® and ™ are trademarks belonging to the Arjo group of companies.
© Arjo 2020.
As our policy is one of continuous improvement, we reserve the right to modify designs without
prior notice. The content of this publication may not be copied either whole or in part without the
consent of Arjo.

3
Content..........................................................................................................................................3
Foreword .......................................................................................................................................4
Intended Use .................................................................................................................................5
Safety Instructions.........................................................................................................................6
Preparations ..................................................................................................................................7
Sara Flex Directions .............................................................................................................7
Parts Designation .........................................................................................................................8
Product Description / Functions.....................................................................................................9
Controls and Features ..........................................................................................................9
LCD Display ........................................................................................................................10
Castor Brakes .....................................................................................................................10
Emergency Stop Button ......................................................................................................11
Power Button ......................................................................................................................11
Leg Support ........................................................................................................................11
Leg Strap ............................................................................................................................11
Leg Strap attachment (optional)..........................................................................................12
Emergency Lowering ..........................................................................................................13
Allowed Slings with Sara Flex ............................................................................................14
Central Hook (Accessory) ...................................................................................................14
Transfer from Wheelchair to Sara Flex .......................................................................................15
Prepare Sara Flex and Patient...........................................................................................15
Place Patient in Sara Flex ..................................................................................................15
Raise a Patient to Standing Position...................................................................................17
Patient Transfer...................................................................................................................17
Transfer from Sara Flex to Toilet.................................................................................................18
Transfer from Sara Flex to Bed/Chair .........................................................................................19
Scale (Optional)...........................................................................................................................20
Using the Scale - Weigh the Patient............................................................................................22
Method A - Weigh the Patient without Sling Weight............................................................22
Method B - Weigh Patient with Sling ..................................................................................23
Changing the Units of Measure ..........................................................................................24
Battery Instructions......................................................................................................................25
Cleaning and Disinfection Instructions ........................................................................................27
Troubleshooting...........................................................................................................................29
Care and Preventive Maintenance ..............................................................................................30
7HFKQLFDO6SHFL¿FDWLRQV ..............................................................................................................34
Dimensions..................................................................................................................................36
Labels on Sara Flex....................................................................................................................37
/LVWRI6WDQGDUGVDQG&HUWL¿FDWHV................................................................................................39
Electromagnetic Compatibility .....................................................................................................40
Parts and Accessories.................................................................................................................42
Content

4
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]HGPRGL¿FDWLRQVRQDQ\$UMRHTXLSPHQW
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¿FDWLRQWRLWVSURGXFWV
Serious incident
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.
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¿QLWLRQVLQWKLVIFU
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.
Means: The name and address of the
manufacturer.

5
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¿HGLQWKLVIFU. Any other use is prohibited.
Patient/Resident Assessment
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.
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
EHXVHGZLWKVSHFL¿FDOO\GHVLJQHGVOLQJV
Expected Service Life
The expected service life is the maximum period of
XVHIXOOLIHDVGH¿QHGE\WKHPDQXIDFWXUHU
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.
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.

6
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
PXVWEHFDUULHGRXWE\TXDOL¿HG
personnel, before attempting to use
Sara Flex.
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.
Policy on Number of Staff
Members Required for Patient
Transfer
$UMR¶VÀRRUOLIWVDUHGHVLJQHGIRUVDIHXVDJH
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.

7
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.
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.
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.
Left
Right
Transfer
direction
Fig. 1

8
Parts Designation
Motor/Actuator
Rear
Castor
Maneuvering
Handle
Mast
Emergency
Stop Button
Control Panel
Lifting Arm
Clip Attachment
Point
Patient/Resident
Handle
Emergency
Lowering Handle
Leg Support
Leg Strap
Footplate
Front Castor
Adjustable
Chassis Leg
Battery
Hand Control
Power Button
Central Hook
(accessory)
Leg Strap
Attachment

9
Product Description / Functions
Controls and Features
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
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
Fig. 2
Fig. 3

10
LCD Display
(See Fig. 4)
Battery Level - see “Battery
Instructions” on page 25.
0.0
Usage counter
Maintenance symbol
0.0
Patient’s weight - see “Scale
(Optional)” on page 20.
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.
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
RQH\HDUWKHPDLQWHQDQFHV\PEROZLOOÀDVKVHF
ON and 1 sec OFF).
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.
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).
0.0
kg
0.0
Fig. 4
Fig. 5
A
B

11
Emergency Stop Button
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).
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.
Fig. 6
Fig. 7
A
Fig. 8
A
B

12
Leg Strap attachment (optional)
Insert strap from the leg strap attachment.
(See Fig. 9)
Fasten strap to the leg pad support.
(See Fig. 10)
Repeat on the other side, if needed.
(See Fig. 11)
Fig. 9
Fig. 10
Fig. 11

13
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)
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.
Fig. 12
Fig. 13

14
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
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.
Central Hook (Accessory)
Only to be used with the transfer sling. The central
hook (See Fig. 16) is to be installed right under the
OLIWLQJDUPE\TXDOL¿HGSHUVRQQHORQO\
Fig. 14
Fig. 15
Fig. 16

15
Place Patient in Sara Flex
(8 Steps)
1. Open chassis legs if needed to accommodate the
width of the chair, bed, etc.
NOTE
,IWKHFKDVVLVOHJVFDQ¿WXQGHUQHDWKWKH
furniture, do not open the chassis legs
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)
4. Ask or assist patient to place his/her hands on the
patient/resident handles.(See Fig. 19)
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).
Fig. 17
Fig. 18
Fig. 19

16
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)
Fig. 20
Fig. 21
Fig. 22
Fig. 23

17
Fig. 24
Fig. 25
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.
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.

18
Fig. 26
Transfer from Sara Flex to Toilet
(18 Steps)
1. Using the maneuvering handle, position patient in
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.
Fig. 27

19
Fig. 28
Fig. 29
Transfer from Sara Flex to Bed/Chair
(11 Steps)
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.

20
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
7KHXQLWPXVWEHVWDWLRQDU\RQDÀDWOHYHO
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.
Display Symbols/Functions
The LCD screen on the hand control can display
ZHLJKWLQNLORJUDPVNJRUSRXQGVOELQVSHFL¿F
markets).
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.
Scale (Optional)
Fig. 30
Scale Symbol Maximum Weight
Warning Symbol