RoMedic Bure Space Gabord Instruction Manual

RoMedic Bure Space Gabord

Bure Space

Max Patient Weight: 150 kg / 330 lbs

IFU no: 942 rev. 1 2022-11-22

Table of contents

• Instructions for use – English

Instructions for Use

Bure Space is a walker that has been specifically designed for the or thopaedics departments and situations where patients require extra legroom to get up closer to wheelchairs or similar. Bure Space is available with electrically operated or hydraulic height adjustment.

Intended Use
The Bure Space is intended to be used in orthopaedics department and situations where patients require extra leg room to get up closer to wheelchairs or similar.

Contraindications, Precautions, Warnings
Always read the user manual. Always make sure that you have the correct version of the manual. The most recent version of all manuals are available for downloading at/from our website: www.directhealthcaregroup.com.

Before use, contact the manufacturer. Occurrence of the following must be checked: frays, loose stitches, damage to the fabric, edging, handles, broken buckles. If any of these points apply, the product should be discarded.

Using Bure Walker

Standing up and walk training, with electrical motor:

1. Ask the patient to sit on the edge of the bed or chair. Bring out the walking table and place it in front of the patient. Lock the brakes on the wheels.
2. Ask the patient to place their arms on the armrests. If necessary, ask the patient to move forward on the seat base so that the patient reaches the handles.
3. Ask the patient to lean forward. To start raising the walking table, press the UP button on the controller. Raise the walking table to a desired height.
4. Unlock the brakes. Adjust the height of the walking table to a desired position.
5. Assist the patient while walk training.

With gas actuator:

1. Ask the patient to sit on the edge of the bed or chair. Bring out the walking table and place it in front of the patient. Lock the brakes on the wheels.
2. Raise the walking table by pressing the handle on the gas piston.
3. Ask the patient to lean forward, grab the armrests and stand up.
4. Adjust the height of the walking table to a desired position.
5. Assist the patient while walking.

Standing Plate
Attach standing plate by hooks on the main frame of the walker.

Raising/Lowering the Frame, Bure electrical actuator
Adjust the height with the aid of the hand control UP and DOWN arrows.

Raising/Lowering the Frame – Bure gas actuator

1. Release the gas strut by moving the handle upward (the gas strut will raise the walker).
2. Let go of the handle at the desired height (the gas strut will lock).
3. Release the gas strut by moving the handle upward. Use your body weight to press the frame down.
4. Let go of the handle at the desired height (the gas strut will lock).

Adjusting the Handles
To adjust handles to the desired position, loosen screw, adjust handle, tighten screw.

Adjustment of Armrests
The armrests can be adjusted sideways for optimal support. To adjust armrests, loosen screw, adjust armrest, tighten screw.

Note: The rear attachments on the frame/armrest are interchangeable (left with right and vice versa) to provide different widths. The locating pins on the cushion’s underside/rear can also be moved. These adjustment capabilities make customization possible.

Bure Space
Bure Space is a walker that has been specifically designed for the orthopaedics departments and situations where patients require extra leg room to get up closer to wheelchairs or similar. Bure Space is available with electrically operated or hydraulic height adjustment.

Intended use

Walkers are indoor, movable and portable assistive aids, which together with approved accessories are intended to be used for transfer from sitting to standing positions, and walking training. Walkers are to be used by persons with reduced muscular strength, who shall be able to stand and perform simple leg movements. Walkers are to be used for leaning on when walking and standing during early mobilisation training. Walkers and accessories are intended for indoor use only in home healthcare environment and professional healthcare facility environment.

The Bure Space is intended to be used in orthopaedics department and situations where patients require extra leg room to get up closer to wheelchairs or similar.

Contraindications, Precautions, Warnings

Contradictions

• The device may not be used by patients above the maximum weight indicated on the label of the device.

Precautions

• Check that the device is used on a dry and flat surface.
• Check the device is correctly mounted/assembled before its first use.
• Check the device after every folding/disassembly after any transport.
• Check height adjustment and leg spreading motions and inspect the actuators or gas pistons full ranges.
• Activate the brakes whenever the device is not in use.
• Check the function of the brakes before use.
• Inspect the device regularly to detect any signs of damage. If there are any visible signs of damage, contact Direct Healthcare Group Customer Service.
• In case of an electrical model of the device, check that the hand control does not show signs of wear before every use.
• In case of an electrical model of the device, check that the hand control markings are in accordance with the lifting functions.
• Check the battery status of an electrically operated model before using the device.
• Warranty applies only if repairs or alterations are made by personnel who are authorized by Direct Healthcare Group.
• Ensure that there are no obstacles or people in the way of the device, when moving.
• Handle batteries with care. Do not drop.
• Use only batteries and cables that are intended for the device as instructed by the manufacturer.
• Verify that potential accessories that might be used are properly attached to the device before use.
• Low speed is recommended when moving with the device.
• Take care not to drive the device over thresholds with high speed or force. Approach the threshold with lower speed and communicate the coming threshold to the patient.
• Keep the instructions for use together with the product so that it can be used as a reference if necessary.
• Beware of moving parts during usage.
• Peform a risk assessment on the patient before using the Walker to ensure they can stand and peform simple movements.

Warnings

• The device may not be used by infants, children or adults who are 146 cm or shorter.
• The caregiver must be able to read and understand the manual/Instructions for use of the product.
• Caregiver: Never use the device if you have not had a proper training on how to use the device including the accessories.
• Maintenance/Service staff: Never maintain the device if you have not had a proper training on how to use and maintain the device including the accessories.
• It is important to use only approved accessories to prevent unintended detachment of components and subsequently a fall that may lead to patient injury.
• Use careful and gentle maneuvers when moving the device.
• Perform maintenance/service of the device, according to the instructions in the Instruction for use, at least once every 12 months.
• No parts of the device shall be serviced, while the device is in use
• Accessories must be properly fitted and tested in relation to the patient’s needs and functional ability.
• Special care must be taken when using strong electrical power sources such as diathermy and the like so that diathermy cables are not placed on or near the device. In case of doubt consult with a Direct Healthcare Group representative.
• When lifting the device, only use the denoted handholds. At least two people are required for lifting the device.
• Do not leave a patient unattended when the device is being used.
• The device can not be used by patient alone.
• Never move the walker by pulling on the actuator device or gas piston.
• The device must not be lowered into water.
• The device must not be cleaned using steam.
• The device must not be left or stored in a damp or humid environment.
• The device must not be charged in a wet room.
• The device must not be used outdoors, only indoors.
• To avoid the risk of electric shock, this equipment must only be conected to a supply mains with protective grounding.
• No modification of this equipment is allowed
• Do not modify this equipment without authorisation of the manufacturer.
• If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of this equipment.
• Do not use the device while it is charging.
• Do not use the device if any of the cables shows signs of wear and tear.
• Do not put the device in direct sunlight as it may get hot.
• Do not run over the cables with the walker or other devices.

Always read the user manual
Always make sure that you have the correct version of the manual. The most recent version of all manuals are available for downloading at/from our website: www.directhealthcaregroup.com.

Before use:

• Inspect the packaging for any damage.
• Check for correct product being delivered.
• Check to ensure that the device is free from damage.
• Check if all the parts/components are included in the packaging.
• Check if all approved accessories are included in the package.
• Check if Product Quality Approval document is included in the packaging. Save this document for future contact with manufacturer.
• Make certain the device is properly assembled.
• Check lifting function and bottom-frame adjustment function.
• Check if it is possible to move the device in all directions.
• Check the condition and function of the sling/belt regularly. Always inspect the product after laundering. The occurence of the following must be checked: frays, loose stitches, damage to the fabric, edging, handles, broken buckles. If any of these points apply, the product should be discarded.

Using Bure Walker

Standing up and walk training, with electrical motor:

1. Ask the patient to sit on the edge of the bed or chair. Bring out the walking table and place it in front of the patient. Lock the brakes on the wheels.
2. Ask the patient to place their arms on the armrests. If necessary, ask the patient to move forward on the seat base so that the patient reaches the handles.
3. Ask the patient to lean forward. To start raising the walking table, press the UP button on the controller. Raise the walking table to a desired height.
4. Unlock the brakes. Adjust the height of the walking table to a desired position
5. Assist the patient while walk training.

With gas actuator:

1. Ask the patient to sit on the edge of the bed or chair. Bring out the walking table and place it in front of the patient. Lock the brakes on the wheels.
2. Raise the walking table by pressing the handle on the gas piston.
3. Ask the patient to lean forward, grap the armrests and stand up.
4. Adjust the height of the walking table to a desired position
5. Assist the patient while walking.

Using Bure Walker with Gait Training Kit 56-388:

• The support harness has four blue straps with a plastic buckle allowing for adjustments in length, having steel carabiner clips at the ends to be fasten to the gait walker. The carabiner clips on to the metal mounts placed under the table of the Gait walker.
• Apply the walker support harness by clipping on the two front carabiners to the front mounters, one on each side of the table.
• Place the patient standing up in the walker. Pull back the harness in between the legs and clip on the carabiners to the back mounters, one on each side of the table. Adjust the harness to the patient by pulling in the back strap loops.
• Observe! Intended use of the trainer support harness is to practise walking. It is not a sitting or lifting aid.

Standing Plate
Attach standing plate by hooks on the main frame of the walker.

Raising/Lowering the Frame, Bure electrical actuator
Adjust the height with the aid of the hand control UP and DOWN arrows.
Hand Control has charge indicator/battery (low, medium, high) and Service indicator.
Service indicator – flashes red after 11 months’ operation. Constant light (red) after 12 months’ operation. This indicates need of yearly maintenance.

Raising/Lowering the Frame – Bure gas actuator

• Release the gas strut by moving the handle upward (the gas strut will raise the Walker). Let go of the handle at the desired height (the gas strut a locked).
• Release the gas strut by moving the handle upward. Use your body weight to press the frame down. Let go of the handle at the desired height (the gas strut will lock).

Adjusting the Handles
To adjust handles to the desired position; loosen screw, adjust handle, tighten screw.

Adjustment of Armrests
The armrests can be adjusted sideways for optimal support; loosen screw, adjust armrest, tighten screw.
NOTE: The rear attachments on the frame/armrest are interchangeable (left with right and vice versa) to provide different widths. The locating pins on the cushion’s underside/rear can also be moved. These adjustment capabilities make customisation possible.

Using the Parking Brakes on Castor Wheels:
When parking the device, activate the parking brake on the lockable castor wheels. Lock the wheels by pressing the green pedal brake down with your foot. To release the brake, press the green protruding part with your foot. The caregiver should assist the patient in activating the parking brake in case the patient cannot activate them him or herself.

Using Hand Brakes:

• Running brakes: Pull the brake levers towards you to reduce speed. You will brake the rear wheel that is located on the same side as the brake lever. If you apply only one of the brakes, the walker will turn to that side. When the lever is released, the braking will stop. Do not use the brakes continuously while the walker is in motion.
• Parking brakes : Push the brake levers forwards from you to activate the parking brakes.
  Be aware that the lever has some resistance before it stops and locks the rear wheel. Pull the brake levers back towards you to release the parking brakes.

Battery Charging
Battery charging must take place when the device is not in use.
Charging starts automatically when power plug is connected to 230V wall socket.

• LED lights YELLOW during charging (at the same time as the charging indicator on the hand control flashes yellow).
• The LED goes out when the battery is fully charged (the same applies to the charge indicator on the hand control).

Control box
Control box – LED lights up yellow during operation, is off when the table is not in use. When the control box is connected to the mains, the LED lights up green. When driving/connected to the mains, the LED lights up yellow. The door on the control box can be opened with a thumb grip.

1. Hand control socket.

2. Battery outlet.
   ( NOTE: Plugs must always be connected to the control box for IP classification to be valid.)

3. Socket for actuator up / down.

4. Socket for plug.

Troubleshooting

If the lifting function cannot be activated, check the following:

• That all cables are properly and securely connected. Pull out the contact and plug it in again firmly.
• That battery charging is not in progress.
• That the battery is charged.

If the device is not working properly, contact your distributor.

If the device makes unusual noises:

• Try to determine the source of the sound. Take the device out of operation and contact your distributor.

Maintenance

• Before maintenance. clean walker according to cleaning instructions.
• The device must undergo thorough inspection at least once per year. Inspection must be performed by authorised personnel and in accordance with Direct Healthcare Group’s instructions.
• Repairs and maintenance may only be done by authorised personnel using original spare parts.
• Power cord may only be replaced by DHG service personnel or technical personnel trained by DHG.
• DHG can provide, upon request neccessary technical information in order to assist maintenace and repair of the device.

Frame
There is no mechanical damage.| If mechanical damage is present, contact DHG Customer Services.
There are no scratches.| Touch up as necessary.
End plugs/lower frame fitted and not damaged.| Fit new end plugs.
Armrest
Armrests are intact| Replace if damaged.
Armrest widening is functional.| Replace lock knob, see parts section.
Handle
Grips are not damaged.| Replace handle grips.
Handle adjustment is functional.| Adjust lock screws/plates as required.
Electronics
Check that the charging cable is con- nected to the control box.| Fit new charging cable; this must always be connected to the control box.
Check that the hand control is connect- ed to the control box.| Connect or fit new hand control as required. Tighten; replace with new fasteners as required.
Check that the battery, actuators and control box are not loose.| If any part needs to be replaced refer to the wiring diagram in the control box wiring section.
Height adjustment
Raising and lowering are functional.| Fit new guide sleeves (in frame) or end plugs (in chrome tubes) as required.
The walker feels stable at maximum height and width.| Tighten all nuts and bolts.
There is no movement between the vertical frame and bottom frame.| Tighten all nuts and bolts.
Height adjustment clamps lock.| Replace clamps.
The electric actuator fitting must be free from movement.| Tighten all nuts and bolts; replace bolts and nuts if necessary.
Height adjustment via hand control is functional. The electric actuator must run smoothly at a constant speed.| Check that the battery/hand control/ actuator are connected accord- ing to the control box wiring section. Charge the battery. See parts section
Castors and brakes
Castors roll easily, tread not damaged.| Replace castors.
The castors are firmly fastened to the lower frame.| Tighten the castor bolt and nut. Use thread locker.
Castor brakes functional on all castors. Handbrake functional.| Replace castors or handbrake assembly. Clean and adjust the brake. The castors are sealed and it is not recommended to dismantle them; instead, replace the whole castor assembly.

Storage and transportation

The walker should be transported and stored in 5°C to 50°C an ormal humidity, 20% to 80 on-condensing.
The air pressure should be between 700 and 1060hPa. Leftmost symbol indicates storage and sportation. Let the walker reach room temperature before the batteries are charged or the walker is used. The walker should not be stored so that it is exposed to dust, or so that the battery or gas piston is exposed to direct sunlight.

Operation
The operating environment should be 5°C to 40°C, relative humidity 20% to 80% non-condensing, and atmospheric pressure 700 to 1060 hPa. See also Technical specification below. Leftmost symbol indicates operating condition.

Cleaning and disinfection

After every use:
Clean the walker armrests and handles. Wipe using a mild soap solution/surface disinfectant. The product is not corrosion proof.
Weekly and possibly more often depending on frequency of use:
If necessary, clean the whole walker with a cloth with warm water or a soap solution and check that the castors are free from dirt and hair. The electronic components (battery, control box, hand control, actuators, cables) should be cleaned with a damp cloth only. To avoid degreasing of the piston rods, the actuators should be retracted to minimum stroke and without load before cleaning. Ensure that the device is dried thoroughly after cleaning.

If disinfection is needed:

70% ethanol, 45% isopropanol or similar should be used.
Do not steam clean due to risk of corrosion.
Do not use cleaning agents containing phenol or chlorine, as this could damage the materials.
In enviroments with high risk of infections use the walker with PU-cushions (Accessory number 57-361-L and 57-361-R)

General Maintenance for gait training Sling:
Read the product label.

Do not use rinsing agent.
To prolong product life, avoid tumble-drying.

Recycling/Disposal
When the product is no longer usable it should be recycled in accordance with legislation and regulations in the country concerned. All electrical parts including batteries must be removed and recycled as electrical components. Ask your local recycling station for further information about how the different materials in the product (metals, plastics, electronics, textiles) should be recycled. Used batteries can also be returned to Direct Healthcare Group or a Direct Healthcare Group distributor for recycling.

Technical Specifications

Control box| Linak, voltage 100V/240V, Max 1.5A, 50/60 Hz, IPX6, Class II (Double insulated)
---|---
Batteries| Linak, 25,2V/2,1Ah, sealed,Li-Ion, 300mA IPX6, Cable length 200mm
Actuator| Linak, DC 24 V, 4,3A, IPX6. Duty cycle: Max 10% or 2 minutes continuous use followed by 18 minutes not in use, Push: 1500N. Stroke 400mm +/-2 mm
Hand Control| Cable length coiled 600 mm, IPX6
IP class| IPX5
Material| Steel
Castors| 125/100/75mm
Weight| 27 kg
Dimensions| For dimensions, see “Dimensions” page
Expected Service life| Walkers: 8 years

Textile products: 2 years under normal use. Two wash cycles a week are considered as normal use. However, the total lifetime is dependent on the use, maintenance and storage of the product.

Max patient weight| 150 kg / 330 Ibs
Operating environment| 5 °C to 40°C, relative humidity 20% to 80% non- condensing, and atmospheric pressure 700 to 1060 hPa.
Storage and transporta- tion environment| 5 °C to 50 °C, relative humidity 20% to 80% non-condensing, and atmospheric.

Environment pressure 700 to 1060 hPa.

Materials in contact with human skin| Materials that patient and operator/caregiver are exposed to during usage of the product for prolonged time:

Meditap B-365 (synthetic leather cushions) P x

Polyurethane (on PU cushions) P Dryflex (handles) P

PA6 + 20% GF (brake lever) P

Hand control C X

Applied parts:| Armrest P Handles P Knee pad P

Foot rest support P

Foot rest support clamps C Handles adjusting knobs C Hand controller and its holder. C

Handles to adjust the armrest width. C Hand control C

Charger C Charger cable C

Footplate P

Accessories

Product label

UDI (Unique Device Identification) can be found within the barcode human readable text. It contains.
(01) EAN code
(11) Date of Manufacture. The date is in the format YYMMDD
Y = Year, M = Month and D = Date.
(21) Serial Number displayed as five digit code.

Table of Symbols

How to report a serious incident
Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the MHRA or another competent authority of the country in which the user and/or patient is established.
UK
info@directhealthcaregroup.com
T: +44 (0) 800 043 0881
F: +44 (0) 845 459 9832
Other:
info.export@directhealthcaregroup.com

Electromagnetic Compatibility (EMC)
Electromagnetic emissions and test levels
The product is intended to be used in the stated environments with electromagnetic levels as specified below. The caregiver and/or user of the product assure that the product is used in such an environment.

Voltage fluctuations and Flicker

emissions

| IEC 61000-3-3| Complies

Electromagnetic Immunity
Acceptance criteria for the EMC pass criteria is unintentional movement above ±10mm is not allowed. The product is intended to be used in the stated environments with electromagnetic levels as specified below. The caregiver and/or user of the product assure that the product is used in such an environment.

Dimensions

wider

| Wheel area diameter
56-304 Bure Space
125mm| 900-1300| 850| 215|

335-500

|

675-800

| 218
100mm| 880-1280| 835| 195| 190
75mm| 850-1250| 830| 165| 188

Parts List

fzb
8| 58-403| Cable Linak Battery BA21 grey| 31| 57-816| Screw MC6S DIN912 8.8 M10x40 fzb
9| 58-404| Blind plug Linak control box| 32| 57-803| Locking washer M10 DIN127-B

6.1×11.8×1.6 fzb

10| 58-405| Bracket Linak Control box/Battery| 33| 57-804| Screw MC6S DIN 912 M8x35 8.8 fzb
11| 7427111| Ferrite sleeve| 34| 57-810| Screw MC6S M8x45 fzb 8,8
12| 57-806| Washer DIN 125 8.4x16x1.5 A2| 35| 57-812| Tapping screw RXS 2,9×4,5 fzb
13| 57-805| Washer BRB DIN125 6,4x12x1,6

fzb

| 36| 57-811| Serrated lock washer DIN 6798 M16
14| 57-373| Bottom frame Bure Space| 37| 57-808| Pin bolt M6x25 8.8 fzb
15| 57-355-1| Middle frame| 38| 57-825| Washer 10,5×18×2 HV 125 fzb
16| 58-335| Telescopic Inner pipe| 39| 57-828| Pop rivet AL/ST DIN 7337 4,8×10
17| 57-747| Plug dome plastic 25dia| 40| 57-792| Washer Cushion
18| 57-049

56-360

57-319

56-357

56-387

57-051

| Castor wheel 125mm brake Castor wheel 125mm w/o brake Castor wheel 100mm brake Castor wheel 100mm w/o brake Castor wheel 75mm brake

Castor wheel 75mm w/o brake

| 41| 57-848| Nordlock 10,7x21x2,5
19| 57-307| Protective cover plastic| 42| 57-817| Lock nut DIN 985 CL6 M10 FZB
20| 57-310| Middle frame bushing| 43| 57-918| Washer 6,5x15x10
21| 56-353| Bure Handle assy| 44| 57-904| Washer 6.4×12.5×2 nylon
22| 57-357-L

57-361-L

| Armrest Cushion Low Left

Armrest Cushion PU Left

| 45| 57-877| Washer 10,5x25x3 svz
23| 57-357-R

57-361-R

| Armrest Cushion Low Right

Armrest Cushion PU Right

|  |  |
Parts for Gas spring 56-307-series

No.| ART No.| DESCRIPTION
1| 57-008-3| Gas spring release housing
2| 57-007| Gas spring Bure
3| 57-329| Throttle handle Bure Gas
4| 56-372| Gas spring fork bracket

Product Overview

Main configuration is following: 125 mm wheels, no handbrakes, cushions made of synthetic leather, regular hand control, no special features. Following variations are possible:

• 125/100/75 mm – indicates diameter of wheels
• Handbrakes – indicates that the model has a handbrake on both handles
• 1 handbrake – indicates that the model has only 1 handbrake on one of the handles
• UK, AUS, US – models designed specifically for these countries
• Linak- means that the model includes electronics from Linak for adjust of the height
• Gas – means that the model includes hydraulic system for adjustment of the height
• Manual – means that the height of the model is adjusted manually
• Plus – means that the model includes a Plus hand control
• Low – means that the model has lower middle frame for shorter patients
• S – means that the model is more narrow than the standard model
• PU – means that the model includes cushions made of Polyurethane

Simple solutions for great results
SystemRoMedic® is the name of Direct Healthcare Group’s unique easy transfer concept, the market’s widest and most comprehensive range of clever, easy-to- use and safe transfer and lifting aids designed to make life easier, both for the user and for the caregiver. SystemRoMedic® is a complete solution that provides for the majority of patient transfer or manual handling requirements. From the simplest to the most complex scenarios, from the lightest to the heaviest. The concept encompasses assistive devices for four different categories of transfers:

• Transfer, assistive devices for manual transfers of users between two locations.
• Positioning, assistive devices for manual repositioning of users within the same location.
• Support, assistive devices for mobility support e.g., during sit-to-stand or gait training.
• Lifting, assistive devices for manual and mechanical lifting of users.

Improved work environment, improved quality of care and cost savings
The philosophy behind SystemRoMedic® is focused on the prevention and reduction of occupational injuries while allowing users to experience a greater sense of independence and dignity. Through a unique combination of training and a complete range of efficient transfer aids, SystemRoMedic® offers improvement of both work environment and quality of care and, at the same time, achieves significant cost savings.

Always make sure that you have the correct version of the manual The most recent version of all manuals are available for downloading at/from our website; www.directhealthcaregroup.com

For questions about the product and its use
Please contact your local Direct Healthcare Group and SystemRoMedic® representative. A complete list of all our partners with their contact details can be found on our website; www.directhealthcaregroup.com.

Type BF Applied Parts
Medical Device Class I. The product complies with the requirements of the Medical Devices Regulation 2017/745.

Direct Healthcare Group Sverige AB
Torshamnsgatan 35,
SE-164 40 Kista, Sweden
Tel: +46 (0)8-557 62 200
info@directhealthcaregroup.com
www.directhealthcaregroup.com

References

• Moving Health Forward | DHG

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