Arjo Sara Combilizer Instructions For Use Manual
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Arjo Sara Combilizer Instructions For Use Manual

Arjo Sara Combilizer Instructions For Use Manual

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INSTRUCTIONS FOR USE
Sara Combilizer
04.KC.01_12EN • 2024-12

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  • Page 1 INSTRUCTIONS FOR USE Sara Combilizer 04.KC.01_12EN • 2024-12...
  • Page 2 © Arjo 2024. 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.

  • Page 3: Table Of Contents

    Contents Foreword...............................5 Intended use..............................6 Safety instructions............................7 Preparations..............................9 Parts designation............................10 Product description/functions........................12 Sara Combilizer directions........................12 Sara Combilizer positions..........................13 Castor brakes............................14 Armrest..............................14 Foot support.............................. 15 Shoulder support............................17 Mattresses..............................17 Pillow................................. 19 Covers............................... 20 Tilt angle indicator............................. 21 Fluid bag attachment loops........................
  • Page 4 Transport..............................47 Cleaning and disinfection......................... 48 Battery instructions........................... 55 Care and preventive maintenance......................56 Troubleshooting............................62 Technical specifications..........................64 Dimensions..............................67 Labels................................70 Electromagnetic compatibility........................74 Parts and accessories..........................76...

  • Page 5: Foreword

    Foreword ® Thank you for purchasing the Sara Combilizer CAUTION Customer contact information Caution means: Failure to follow these For questions regarding this product or other instructions may cause damage to all or parts of Arjo products and services, contact Arjo, an Arjo the system or product.

  • Page 6: Intended Use

    If the patient does not meet the above criteria an alternative piece of equipment or system should Sara Combilizer is intended to be used to move be utilized. the patient from a supine to a standing position and move from a supine to a sitting position.

  • Page 7: Safety Instructions

    Safety instructions WARNING WARNING To prevent injury, always read this To prevent entrapment of the patient's Instructions for use and accompanied or caregiver's legs or feet, make sure documents before using the product. that they are kept clear of all obstacles. WARNING WARNING To prevent injury, make sure that the...
  • Page 8 WARNING To prevent risk of injury do not place Sara Combilizer with patient in head down tilt greater than -15°. Degree of tilt can be assessed on the tilt angle indicator located under the head section of the Sara Combilizer.

  • Page 9: Preparations

    Parts designation in this IFU. If any part Actions before every use is missing or damaged - do NOT use the 1. Check that all parts of the Sara Combilizer are product. in place. Compare with the Parts Designation 7.

  • Page 10: Parts Designation

    Parts designation Front view 1. Head safety belt * 11. Castor brake (one on each * = detachable part castor) 2. Shoulder safety belts * Extra items delivered: 12. Emergency function box 3. Chest safety belt * • one head pillow cover 13.

  • Page 11: Rear View

    Rear view 1. Transport handle 10. Leg support plate 2. Hand control cable connection point 11. Side transport handle (x2) 3. Protection plug * (for hand control con- 12. Attachment slot (x4) (for fluid bags) nection point) 13. Spring lock (x2) (for armrest height) 4.

  • Page 12: Product Description/Functions

    For information about safety belts see section Safety belts on page 26. Sara Combilizer directions Left and right The Sara Combilizer has a left (A) and right (B) side. Patient position When using the Sara Combilizer always position the patient with the patient’s head towards the head end (C) and the feet towards the foot end (A).

  • Page 13: Sara Combilizer Positions

    To save space, store the Sara Combilizer in chair position. Tilted position (left/right) A sideways tilt of the Sara Combilizer can be performed in the following positions: stretcher, chair and tilt table. Trendelenburg position When in horizontal stretcher position the product can be tilted to a Trendelenburg position (more than -12°).

  • Page 14: Castor Brakes

    Release the brake: Slightly kick up the grey castor brake lever. Armrest The Sara Combilizer has two armrests. The Adjust armrest height armrests are adjustable for width and height and There are multiple height positions to choose can also be removed.

  • Page 15: Foot Support

    3. Pull out and remove the armrest. Foot support 2. Grab the bar and pull or push the armrest to The Sara Combilizer has a foot support. The foot adjust the width. support is adjustable for length. It can also be removed.
  • Page 16 When Sara Combilizer is in tilt table position, the 3. Release the catch (A). foot support should be in its highest uppermost position. 4. Make sure that the foot support is secured by pushing and pulling it up and down.

  • Page 17: Shoulder Support

    (A). Shoulder support 4. The shoulder support (C) will fold down. The Sara Combilizer has two shoulder supports. Fold up shoulder support The shoulder supports are adjustable for width 1. Lift up the shoulder support until it locks into and can also be folded or removed during place.
  • Page 18 It is recommended to have the Sara Combilizer in 2. Always use the inner shorter slot for the chair position when attaching or removing the attachment straps, when applicable. mattresses. 3. Turn the attachment strap and pull it to secure its attachment.

  • Page 19: Pillow

    2. Lift up the head mattress and remove it from the back support plate. Pillow The Sara Combilizer head pillow supports the 2. Remove the mattress. patients head. The head pillow has two straps with buckles at the end (A). The pillow also has Attach head mattress two slip locks for attachment of head belt (B).

  • Page 20: Covers

    Attach pillow Remove the mattress and pillow covers 1. Place the pillow on the head mattress. 1. Unzip the cover. • Body mattress: on the top. • Head mattress: on the bottom. 2. Place the straps around the back support •...

  • Page 21: Tilt Angle Indicator

    Side transport handles On each side of the seat plate, there are handles Tilt angle indicator (A) to be used when moving the Sara Combilizer The tilt angle indicator displays the degree of the sideways. angle when raising and lowering the tilt table.
  • Page 22 When the battery is indicating empty it is still possible to do the following: • Lower the chair/stretcher/tilt table. • Change from chair to stretcher position. • Tilt left/right. • Tilt upright/tilt back, chair or stretcher. No other movements are possible. See section Battery instructions on page 55 for more information on the battery.

  • Page 23: Control Functions

    Control functions Controls • up/down • tilt left/right tilt table The Sara Combilizer has two control units: Hand control and Control panel Normal mode (blue): The following movements are possible. • Hand Control: The hand control can be used to change the Sara Combilizer into all •...

  • Page 24: Mode Indication On Control Panel

    • Press the selected buttons on the hand control to get Sara Combilizer in horizontal stretcher position and at its lowest height. • Press the selected change of mode button (the LED light will start to blink to show that Sara Combilizer is preparing for change of mode).

  • Page 25: Button Functions

    During a tilt left or right, the stretcher or chair will stop for 3 seconds when a horizontal position is reached. If the button is continuously pressed down, the Sara Combilizer will stop and then continue to tilt to the other side.

  • Page 26: Safety Belts

    Safety belts The shoulder safety belts consist of one belt with The Sara Combilizer has the following safe- padding and covers (E) and one belt with an ty belts: attachment strap (D). The shoulder safety belt A: Head safety belt...
  • Page 27 Always use the chest, hip and knee safety belts (padding closest to the patient’s body). when the Sara Combilizer is in the tilt table position. If needed, use the shoulder and head 3. Attach safety belt attachment straps to belt.
  • Page 28 Chest safety belt 2. Position the hip safety belt on the patient’s hip (4 steps) area over the pelvic bone. 1. Make sure the chest safety belt is buckled into 3. Buckle the hip safety belt into the other middle one of the upper belt attachment straps (A).
  • Page 29 Shoulder safety belts 1. Pull the head safety belt through the slip lock (5 steps) on both sides of the pillow. 1. Attach the two slip locks for shoulder safety belts (A) through the upper slots in the back support plate (B), between the head and body mattresses.

  • Page 30: Emergency And Safety Functions

    Emergency and safety functions Pinch protection bar NOTE The Sara Combilizer is equipped with a pinch The number of caregivers to be present protection bar (A). When the pinch protection during treatment depends on local bar is pressed down, it automatically stops any routines and patient assessment.

  • Page 31: Tilt Table Release Function

    (B) describing the • Stretcher: Changes from chair to lowering procedure. stretcher position (D). 4. Remove the patient from the Sara Combilizer. 5. Call for qualified service personnel. NOTE When the emergency function box has been used, contact qualified service...
  • Page 32 3. Prior to patient lowering make sure that all IV and monitoring lines, drains, fluid bags and WARNING catheters attached to the patient have enough To prevent injury of the patient’s slack, to minimise the risk of accidental neck and back during emergency disconnection during lowering lowering, be aware that both the caregiver's hands must be kept on...
  • Page 33 Further actions after lowering • If needed, adjust the stretcher height. The height of the stretcher will depend on the angle of the tilt table before using the Tilt table release function. • If the patient’s condition requires him/her to be placed in a Trendelenburg position, use the Tilt back button.

  • Page 34: Operation

    IFU. 1. Pull out the spring lock (A) and fold down the shoulder support (B) on the Sara Combilizer as needed. 9. Place a pillow under the patient’s head. 10. Position the Sara Combilizer next to the bed. OPERATION...
  • Page 35 Adjust the height of Sara Combilizer so that obstacles nearby. it is 2 to 5 cm (1 to 2 inches) lower than the bed.
  • Page 36 To prevent the patient from falling, always remove any sliding aid from under the patient once the transfer is complete. Move the Sara Combilizer from the bed and position one caregiver on each side of Sara Combilizer. WARNING 19. Remove the sliding aid (Use local technique).

  • Page 37: Transfer To Bed

    21. Place the Sara Combilizer pillow under the patient’s head and buckle the straps under WARNING the transport handle. To prevent falling during transfer, always make sure that the brakes on 22. Fold up the shoulder supports and adjust the the equipment receiving the patient width to fit the patient.
  • Page 38 Lower Sara Combilizer and make sure it is on top of the bed for an even transfer. WARNING 8. Pull out the spring lock (A) and fold down the...
  • Page 39 16. Release the brakes and move the Sara Combilizer away from the bed. WARNING To prevent falling during transfer, always make sure that the brakes on the equipment receiving the patient are applied. Transfer the patient with the sliding aid to the bed.

  • Page 40: Transfer From Sitting To Standing

    Apply the brakes on the aid. 3. Make sure that Sara Combilizer is in an upright and lowest chair position. For position instructions, see section Change position on page 43.

  • Page 41: Transfer From Standing To Sitting

    Apply the brakes on Sara Combilizer. 13. Support the patient and guide him/her towards the aid. 2. Make sure that the Sara Combilizer is in an upright and lowest chair position. 3. Fold down the shoulder support on the transfer side.
  • Page 42 IFU. 11. Slowly lower the Sara Combilizer until the patient’s feet reaches the floor. 8. Adjust the height on the Sara Combilizer to the patient’s sitting height. 12. Tilt Sara Combilizer to a horizontal chair position. Support the patient.

  • Page 43: Change Position

    17. head section of the Sara Combilizer. Change position The Sara Combilizer can be set to various positions during use: Stretcher position, Tilt Max -15° table position, Chair position upright, Chair...
  • Page 44 • Inform the patient about the planned activity. (This applies to unconscious patients as well). • Adjust the Sara Combilizer to fit the patient’s needs. See section Product description/ functions on page 12. • Check that the knee belts are attached loose when changing from stretcher to chair position.
  • Page 45 Change positions overview Mode: Chair and stretcher position - up and down Mode: Stretcher to tilt table/Tilt table to stretcher Mode: Stretcher to chair/Chair to stretcher Continued on next page OPERATION...
  • Page 46 Mode: Tilt chair back/Tilt chair upright Mode: Stretcher to Trendelenburg/Trendelenburg to stretcher Mode: Tilt left or right OPERATION...

  • Page 47: Transport

    Transport without patient 1. When transporting the Sara Combilizer without a patient, place the Sara Combilizer in an upright chair position. 3. Make sure that the foot support is adjusted to fit the patient’s length. See section Foot support on page 15.

  • Page 48: Cleaning And Disinfection

    Infection fungal spores. Control Specialist. The Sara Combilizer should be routinely cleaned CAUTION and disinfected between patients and at regular To prevent damage to the product, only intervals while in use; as is good practice for all use the chemicals that are listed in this reusable medical devices.

  • Page 49: General Instructions For Cleaning And Disinfection

    Clean and disinfect the Sara Combilizer completely on page 51. Preparation 1. Place the Sara Combilizer in a chair position (normal mode). Continued on next page CLEANING AND DISINFECTION...
  • Page 50 2. Adjust the height of the chair to an ergonomic working height. 12. Spray with approved disinfectant on all parts of the Sara Combilizer that have been in 3. Make sure either the protection plug or the contact with the patient.
  • Page 51 Preparation 8. Detachable parts may be rinsed under flowing 1. Place the Sara Combilizer in a tilt table lukewarm water. position (standing mode). 9. Wash the covers according to section Wash 2. Adjust the height to an ergonomic working and dry textiles on page 53.
  • Page 52 21. Let all parts dry. padding Clean the back 11. Spray with Arjo verified detergent on all front 22. Spray the Arjo verified detergent on all parts parts of the Sara Combilizer, on the hand of the back of the Sara Combilizer.
  • Page 53 Safety belts with belt attachment straps: Tumble dry with the buckles at a 41. Attach the mattresses, pillow, armrests, belt maximum of 60 °C (140 °F). attachment straps and the safety belts on the disinfected Sara Combilizer. Continued on next page CLEANING AND DISINFECTION...
  • Page 54 43. Put the protection plug in a safe place for next cleaning/ disinfection occasion. 44. Connect the hand control. 45. Lower the Sara Combilizer from a tilt table position to a stretcher position. 46. Change to Normal mode and place the Sara Combilizer in a chair position.

  • Page 55: Battery Instructions

    Battery instructions • It is recommended that a battery not in use is left in the battery charger. There is no risk of WARNING overcharging the battery. To prevent injury, do NOT crush, puncture, open, dismantle or otherwise Battery service life mechanically interfere with the battery.

  • Page 56: Care And Preventive Maintenance

    Care and preventive maintenance Under normal use the product is subject to wear and tear. Perform the following actions when specified to make sure that the product remains within its original manufacturing specifications. WARNING To prevent malfunction resulting in injury, make sure to conduct regular inspections and follow the recommended maintenance schedule.
  • Page 57 CAREGIVER / FACILITY OBLIGATIONS Action Before Between Every Each Every Every 5th each use patients week quarter year year Perform a functionality ● test Test emergency stop ● function Test pinch protection ● bar function Replace safety belts ● Replace textile covers ●...

  • Page 58: Before Every Use

    Visually check all exposed parts Before every use 1. Place the Sara Combilizer in tilt table end Visually check safety belts position (75°). Before each use of the Sara Combilizer the safety belts must be checked, place the Sara Combilizer in tilt table end position (75°).
  • Page 59 • Apply one brake at a time. With the brake applied, the castor shall not move forward when the Sara Combilizer is being pushed. Repeat on all four brakes. • Apply all four brakes. Push the Sara •...
  • Page 60 Test all movements from start to end position. All buttons must be working according to section Control functions on page 23. • Make sure that the Sara Combilizer stops and • Check for abnormal sounds during the no further movements occurs.
  • Page 61 NOTE All caregiver/facility obligations are to be checked when performing the yearly service. CARE AND PREVENTIVE MAINTENANCE...

  • Page 62: Troubleshooting

    Troubleshooting Always make sure that the Sara Combilizer battery is charged or changed and that it is correctly inserted before taking further actions. Perform the actions in the described order. After each step check if the problem still persists before going to the next step.
  • Page 63 1. Check that the foot support is not touching the floor. not work in Standing Mode. 2. If the foot support is touching the floor, Sara Combilizer should be lowered and the foot support adjusted to its highest inner- most position.

  • Page 64: Technical Specifications

    Safe working load (SWL) = Maximum total load 200 kg (440 lb) Maximum patient weight 200 kg (440 lb) Max total weight (Sara Combilizer + patient) 315 kg (694 lb) Weight of Sara Combilizer 115 kg (254 lb) Model and Type...
  • Page 65 3.1 kg (6.8 lb) Weight textile kit 6.1 kg (13.4 lb) ALLOWED COMBINATION Sara Combilizer integrates with the following Arjo Maxi Sky 440, Maxi Sky 600, Maxi Sky 1000, products. Maxi Sky II, Maxi Move with extra low castors, Walker, Sara Plus, Concerto, Carevo, Over bed...
  • Page 66 OPERATING, TRANSPORT AND STORAGE Humidity 20-80% Rh at +30 °C (+86 °F) Operating 20-80% Rh at +30 °C (+86 °F) Transport - No condensing 20-80% Rh at +30 °C (+86 °F) Storage - No condensing Atmospheric pressure 800 hPa to 1060 hPa Operating 800 hPa to 1060 hPa Transport 800 hPa to 1060 hPa Storage RECYCLING...

  • Page 67: Dimensions

    Dimensions Measurements in mm (inches). Measuring tolerances > 200 mm ± 20 mm (> 7 7/8 inches ± 3/4 inches ) ≤ 200 mm ± 5 mm (≤ 7 7/8 inches ± 1/4 inches ) Angles ± 2° Max and min height of stretcher 1890 (74 3/8) 2045 (80 1/2) Max.
  • Page 68 Max. height and depth of tilt table Length, width and hight of chassis Chair side tilt Tilt angle up/down 20° 0° 20° 75° 0° -25° 1034 (40 3/4) DIMENSIONS...
  • Page 69 Max and min height of chair Width back rest and seat Width arm rests Length of chair in upright and tilted position 615 (24 1/4) 510 (20 1/8) 1580 (62 1/4) 1840 (72 3/8) Turning radius stretcher Turning radius chair DIMENSIONS...

  • Page 70: Labels

    10. Tilt table release function label 4. Safe Working Load label - States the maximum total load 11. Shoulder support labels that may be on the Sara Combilizer. 5. Emergency function box label 6. Identification label on safety belts and attachment straps (total of 16).
  • Page 71 Name and address of the manufacturer Defines the maximum total load of resident or any other load that may be on the Sara Combilizer Total mass of equipment including its Safe Working Load Type B Applied part: Protection against electrical shock in accordance with IEC 60601‑1.
  • Page 72 SYMBOL EXPLANATION Adjust shoulder support left side Adjust shoulder support right side Adjust foot support Foot support identification Machine wash at 70°C (158°F) Machine wash at 60°C (140°F) Do not use bleach Tumble dry possible with normal temperature Do not iron Separate electrical and electronic components for recycling in accordance with the European Directive 2012/19/EU (WEEE) Environmental danger.
  • Page 73 UK marking indicating conformity with UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) UK Responsible Person & UK Importer: Arjo (UK) Ltd, ArjoHuntleigh House, Houghton Regis. LU5 5XF For Northern Ireland (NI) CE marking will still apply until further amendment to applica- ble regulations.

  • Page 74: Electromagnetic Compatibility

    Electromagnetic compatibility Product has been tested for compliance with current regulatory standards regarding its capacity to block EMI (electromagnetic interference) from external sources. Some procedures can help reduce electromagnetic interferences: • Ensure that other devices in patient-monitoring and/or life-support areas comply to accepted emissions standards.
  • Page 75 GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY Immunity test IEC 60601-1-2 test level Compliance level Electrostatic dis- ±2kV, ±4kV, ±8kV, ±15kV air ±8kV ±2kV, ±4kV, ±8kV, ±15kV air ±8kV charge (ESD) EN contact contact 61000-4-2 Conducted disturban- 3V in 0,15 MHz to 80 MHz 3V in 0,15 MHz to 80 MHz ces inducted by RF 6V in ISM and amateur radio bands...

  • Page 76: Parts And Accessories

    Battery charger Battery charger 8350891-031 NEA8000 NEA8100-WW For disinfectant contact the local Body Mattress Head Mattress Arjo representative Complete –AH1004031 Complete – 8663942-014 Only cover – AH1004035 Only cover – 8663943-014 Pillow *Armrest Cushion Shoulder Belt, two pieces Complete – 8663947-013 Complete –...
  • Page 77 Chest and Hip Belt, two pieces Knee Belt *Knee Belt Strap 8547119-013 8547120-013 AH1033148 *Order two, to replace the complete pair. PARTS AND ACCESSORIES...
  • Page 78 Intentionally left blank...
  • Page 79 AUSTRALIA FRANCE POLSKA Arjo Australia Arjo SAS Arjo Polska Sp. z o.o. Building B, Level 3 2 Avenue Alcide de Gasperi ul. Ks Piotra Wawrzyniaka 2 11 Talavera Road CS 70133 PL-62-052 KOMORNIKI (Poznań) Macquarie Park, NSW, 2113, Australia FR-59436 RONCQ CEDEX...
  • Page 80 At Arjo, we believe that empowering movement within healthcare environments is essential to quality care. Our products and solutions are designed to promote a safe and dignified experience through patient handling, medical beds, personal hygiene, disinfection, diagnostics, and the prevention of pressure injuries and venous thromboembolism. With over 6500 people worldwide and 65 years caring for patients and healthcare professionals, we are committed to driving healthier outcomes for people facing mobility challenges.

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