ARJOHUNTLEIGH Sara Flex Instructions for Use Rev 3 Jan 2018

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 ArjoHuntleigh group of companies. © ArjoHuntleigh 2017. 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 ArjoHuntleigh. 2

Content 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 Emergency Lowering ...12 Allowed Slings with Sara Flex ...13 Central Hook (Accessory) ...13 Transfer from Wheelchair to Sara Flex ...14 Prepare Sara Flex and Patient...14 Place Patient in Sara Flex...14 Raise a Patient to Standing Position...16 Patient Transfer...16 Transfer from Sara Flex to Toilet ...17 Transfer from Sara Flex to Bed/Chair ...18 Scale (Optional) ...19 Using the Scale - Weigh the Patient ...21 Method A - Weigh the Patient without Sling Weight ...21 Method B - Weigh Patient with Sling ...22 Changing the Units of Measure ...23 Battery Instructions ...24 Cleaning and Disinfection Instructions ...26 Troubleshooting ...28 Care and Preventive Maintenance ...29 Technical Speci¿cations ...33 Dimensions ...35 Labels on Sara Flex...36 List of Standards and Certi¿cates...38 Electromagnetic Compatibility (EMC) ...39 Parts and Accessories ...41

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Foreword Thank you for purchasing ArjoHuntleigh equipment.

De¿nitions in this IFU

WARNING

Please contact us if you have any questions about the operation or maintenance of your Means: Safety warning. Failure to understand and ArjoHuntleigh equipment. obey this warning may result in injury to you or to Please read and fully understand these others. Instructions for Use (IFU) before using Sara Flex.

CAUTION 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. Unauthorized modi¿cations on any ArjoHuntleigh equipment can affect safety. ArjoHuntleigh will not be held responsible for any accidents, incidents or lack of performance that occur as a result of any unauthorized modi¿cation to its products.

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.

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 29. If further information is needed, contact your local ArjoHuntleigh representative for replacement parts. The contact information appear on the last page of this IFU.

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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.

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.

If there is anything that remains unclear, contact your ArjoHuntleigh 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, nursing homes, assisted living and group homes and home care facilities 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.

CAUTION To avoid product damage do not use Sara Flex outdoors. The product is intended to be used with speci¿cally designed slings.

Expected Service Life The expected service life is the maximum period of useful life as de¿ned by the manufacturer. 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.

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 speci¿ed in this IFU. Any other use is prohibited.

Actual service life may vary depending on the frequency of use and conditions.

Patient/Resident Assessment

It is recommended that facilities establish regular assessment routines to make sure that caregivers are The IFU shall be available as long as reasonably necessary, taking the lifetime of the device into assessing each patients/residents prior to use. consideration. Before use the caregiver should always consider the Other consumable parts, e.g. batteries, sling, etc. are patients/residents medical condition, physical and also subject to wear and their expected operational mental capabilities. life is dependent on usage.

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Safety Instructions Policy on Number of Staff Members Required for Patient Transfer

WARNING To avoid injury, make sure that the patient is not left unattended at any time.

ArjoHuntleigh’s Àoor lifts are designed for safe usage 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 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 must be carried out by quali¿ed 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.

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Preparations Actions Before First Use (4 steps)

Sara Flex Directions

1.

Left and right

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.

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

Actions Before Every Use (2 steps)

Left

1.

Visually inspect Sara Flex. If any part is damaged - do NOT use the product. 2. Check the battery level.

Right

In between Use Clean and disinfect the product according to section “Cleaning and Disinfection Instructions” on page 26.

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Parts Designation Maneuvering Handle

Lifting Arm

Patient/Resident Handle Clip Attachment Point

Mast

Leg Support

Leg Strap

Adjustable Chassis Leg

Footplate

Front Castor

Central Hook (accessory)

Hand Control

Control Panel Emergency Lowering Handle

Emergency Stop Button

Motor/Actuator

Power Button Battery

Rear Castor 8

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 Left Dash

If a pressed button is released, it will stop its function immediately. Fig. 3

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 Fig. 4

(See Fig. 4)

0.0

0.0

0.0

Battery Level - see “Battery Instructions” on page 24. Usage counter Maintenance symbol

kg

weight - see “Scale 0.0 Patient’s (Optional)” on page 19. 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 one year. the maintenance symbol will Àash (1 sec 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.

Fig. 5

A

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.

B

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). 10

Fig. 6

Emergency Stop Button 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) Fig. 7

Leg Support A

Fig. 8

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.

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Emergency Lowering Fig. 9

The Emergency Lowering allows the lifting arm to be lowered in the event of a main control failure. In the event of a hand control or control panel failure, ¿nd the red handle on the actuator. Gradually pull the red handle up and hold it until the lifting arm is lowered to the desired level. The force applied by pulling the red handle and the patient weight affects the speed of lowering. (See Fig. 9) You may need to assist the lowering by applying downward force on the lifting arm.

WARNING To avoid injury, always make sure that a suitable support is placed underneath, ready to receive the patient, before operating the Emergency Lowering function. The handle is spring loaded and will return to its original position. It stops the lowering process once the red handle is released. NOTE Note that a load must be applied to the lifting arm for the Emergency Lowering function.

CAUTION To avoid product damage, emergency lowering should only be used in the event of control failure and not as a regular lowering function for the product.

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. 10

The following slings are compatible with Sara Flex. Active Slings (See Fig. 10) • TSS.500 (S) • TSS.501 (M) • TSS.502 (L) • TSS.503 (XL) • TSS.504 (XXL) Flites • MFA3000 (Flite)

Fig. 11

Transfer Sling (See Fig. 11) • TSS.511 (Transfer Sling Model, only to be used with Central Hook) For sling selections see respective sling IFU.

Central Hook (Accessory) Fig. 12

Only to be used with the transfer sling. The central hook (See Fig. 12) is to be installed right under the lifting arm by quali¿ed personnel only.

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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 If the chassis legs can ¿t underneath the furniture, do not open the chassis legs

Fig. 13

2.

Fig. 14

3. Push Sara Flex towards the patient until it gently touches the patient’s shins. (See Fig. 14)

Fig. 15

4.

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Ask or assist the patient to place his/her feet on the foot plate. (See Fig. 13)

Ask or assist patient to place his/her hands on the patient/resident handles.(See Fig. 15)

Fig. 16

5.

Attach sling clips to attachment points on the Sara Flex lifting arm. (See Fig. 16)

6.

Make sure the clips are attached securely. (See Fig. 17)

7.

When using a transfer sling, also attach the loops on the central hook (accessory) located right under the lifting arm. (See Fig. 18)

8.

Attach the leg strap to support the patient’s legs, if needed. (See Fig. 19)

Fig. 17

Fig. 18

Fig. 19

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Fig. 20

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. 21

3.

Use the hand control to raise patient from sitting position to standing position. (See Fig. 20) 4. While the patient is standing, check the supports. 5. Tighten safety straps around the abdomen, if needed.

Patient Transfer (2 Steps) (See Fig. 21) 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. Fig. 22

Using the maneuvering handle, position patient in front of the toilet/commode or device that patient will sit on. (See Fig. 22) 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 .

Fig. 23

6.

Apply the castor brakes to keep Sara Flex in position once the patient is sitting on the toilet. (See Fig. 23) 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. 15) 14. Attach sling clips to attachment points on the Sara Flex lifting arm. (See Fig. 16) 15. Make sure the clips are attached securely. (See Fig. 17) 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 16.

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Transfer from Sara Flex to Bed/Chair (11 Steps) Fig. 24

Fig. 25

1.

Apply the brakes on the wheelchair, if applicable.

2.

Adjust chassis legs if needed to go around bed/ chair. (See Fig. 24)

3.

Lower the patient onto the surface of bed/chair. (See Fig. 25)

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 26 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 The unit must be stationary on a Àat level 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 weight in kilograms (kg) (or pounds (lb) in speci¿c markets). The minus sign (-) appears when the weight is negative (see “Method B - Weigh Patient with Sling” on page 22”). Fig. 26

Scale Symbol

Overload Warning Symbol

Maximum Weight Warning Symbol

The maximum weight warning symbol appears when the patient weight exceeds the Safe Working Load (SWL) 200 kg (440 lb). (See Fig. 26) 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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Fig. 27

Net weight

NET

This is the Net weight of the patient without any accessories e.g. sling. (See Fig. 27) For instruction on how to get the Net weight of the patient, see “Method A - Weigh the Patient without Sling Weight” on page 21

0.0 kg

Save weight

Fig. 28

NET

144.0

B

kg

To use the Save function, press the left dash button (A), to store the weight on the scale. (See Fig. 28) 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

A

Fig. 29

Tilt (for class III scale only) The display will switch between the scale symbol with a tilted symbol.

Scale Symbol

Tilt 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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