DHG Bure Standard/S Bure Low/S Instruction Manual

DHG Bure Standard/S Bure Low/S

Intended use

Walkers are to be used as 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 mobilization training. Walkers and accessories are intended for indoor use only in Home Healthcare environment and Professional Healthcare facility environment.

Contraindications, Precautions and Warnings

Contraindications

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.

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.
It is important to never leave the user alone during the transfer.
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 user.

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.
Perform a risk assessment on the user before using the Walker to ensure they can stand and perform simple movements.
Warnings

The caregiver must be able to read and understand the Manual/IFU of the product.
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 manual/IFU, at least once every 12 months.
Accessories must be properly fitted and tested in relation to the user’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 care recipient unattended during a transfer.
Never move the lift by pulling on the actuator 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 earth.
No modification of this equipment is allowed
Do not modify this equipment without authorisation of the manfacturer
If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of this equipment.

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.

Standing Up Using the Bure

With electrical components:

1. Ask the user to sit on the edge of the bed or chair. Bring out the walking table and place it in front of the user. Lock the brakes on the wheels.
2. Ask the user to place their arms on the armrests. If necessary, ask the user to move forward on the seat base so that the user reaches the handles.
3. Ask the user 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. Assist the user while walking.

With gas piston:

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

Using Bure Walker with Gait Training Kit 56-388

• The gait 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 gait walker support harness by clipping on the two front carabiners to the front mounters, one on each side of the table.
• Place the user standing up in the Gait 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 user by pulling in the back strap loops.
• Observe! Intended use of the Gait trainer support harness is to practise walking. It is not a sitting or lifting aid.

Raising/Lowering the Frame – Electric
The desired height is adjusted with Arrow or Arrow .
Handset TiMOTION Plus also have charge indicator / battery (low, medium, high) and Service indicator (see further under “17 Hand Control Plus”).

Raising/Lowering the Frame – Gas
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; undo knob, adjust handle, tighten knob.

Left and Right Adjustment of Armrests
The armrests can be adjusted sideways for optimal support; undo knob, adjust armrest, tighten knob.

Locking/Unlocking Castors
Depress the foot brake to set it and lock the castor.
Press down on the protruding part of the brake to release it.

Control Box Wiring
Remove the control box cover to make the connections as described below. Use a screwdriver or similar; refer to the special labels on the control box.
NOTE: Make sure that plugs are connected to the correct sockets otherwise the actuators can be damaged.

1. Socket for the raise/lower actuator.
2. Hand control socket.
3. Battery terminal socket.
4. Plug socket. NOTE: The plug must ALWAYS be connected to the control box for IP protection to be valid.

Battery Charging

• Plug needs to connect to 230V wall socket. Charging starts automatically.
  • LED / battery flashes green.
• The battery is of the LiOn type and insensitive to how long / how often you charge the battery. Full charge on discharged battery takes about 24 hours.
• We recommend that the battery plug be removed from the control box if the product will be out of use for an extended period (more than one week) or if the battery is switched off by means of the ON/OFF switch. This eliminates the risk of disabling the battery as the control box always uses a small quantity of electricity even when the Walker is not in use.

LEDs on Control Box and Battery

Control box – green light when power is available from battery/mains socket.

Battery:

• The LED flashes green during charging.
• ON/OFF: To use the product, press ON.
• The green lamp will begin to flash.
• Use the OFF button (hold down for 5 s) to switch off the battery if the product will not be used for an extended period.
• The LED will shows a constant green light when the battery is fully charged.
• When the battery is in normal state/in operation, the LED flashes green at REGULAR intervals, namely 0.5 s ON, 4 s OFF.
• When the battery requires charging (remaining charge <25%) the LED will flash orange/red at REGULAR intervals, namely 0.5 s ON, 4 s OFF.

NOTE: The battery has an in-built device that automatically switches it off when remaining charge is <20%. The LED is then extinguished. The battery must now be fully charged before the electronics can be used again.

Maintenance

Check that everything is clean and working before using.
Recommended at least once per year

General

The Walker feels firm/free from play. The Walker does not rattle during manoeuvres.

The Walker is level and all of its cas- tors are in contact with the floor.

The Walker is not dirty.

| Clean with lukewarm soap solution or alcohol-based cleaning agent (no petroleum products).
Armrest

Armrests are intact and clean. Armrest widening is functional.

| Clean; replace if damaged.

Fit lock screws/plates as required.

Handle

Grips are not damaged/dirty. Handle adjustment is functional.

| Clean with lukewarm soap solution (no petroleum products). Replace handle grips.

Fit lock screws/plates as required.

Battery

Check that the charging cable is connected to the control box. Check that the hand control is con- nected to the control box.

Check that connections are made according to the wiring diagram. Check that the battery, actuators and control box are not loose.

| Fit new charging cable; this must always be connected to the control box (IP65 protection).

Connect or fit new hand control as required.

Refer to the wiring diagram in the control box wiring section. Tighten; replace with new fasteners as required.

Height adjustment

Raising and lowering are functional. The Walker feels stable at maximum settings.

There is no play between the vertical frame and bottom frame.

Height adjustment clamps lock. The electric actuator fitting must be free from play.

Height adjustment via hand control is functional. The electric actuator must run smoothly at a constant speed.

| Fit new guide sleeves (in frame) or end plugs (in chrome tubes) as required.

Tighten all lock bolts. Replace clamps.

Tighten the attachment fitting concerned; replace bolts/lock nuts as necessary.

Check that the battery/hand control/ actuator are connected in accordance as in the control box wiring section. Charge the battery. Contact customer services.

Refer to the wiring diagram in the control box wiring section.

Frame parts

There is no mechanical damage. There are no scratches.

End plugs/lower frame fitted

| If damage is present, contact DHG customer services. Touch up as necessary.

Fit new end plugs.

Castors/brakes

Castors roll easily/tread not damaged. The castors are firmly fastened to the lower frame.

Castor brakes functional on all castors.

Handbrake functional.

| Clean or replace castors. NOTE: Castors are always fixed to the lower frame with thread locker or lock.

nuts. Do not dismantle the castors; replace the whole castor assembly instead.

Tighten the castor bolt and fit locking nut or use thread locker (depends on model).

Replace castor assembly.

Adjust the brake or fit new castors.

DHG can provide upon request necessary technical information in order to assist maintenance and repair of the device.

General Maintenance Advice & Cleaning of Walker

• Clean the walker armrests and handles after every use. Wipe using a mild soap solution/surface disinfectant. However, the product is not corrosion proof.
• With environments with high risk of infections use the walker with PU-cushions (Accessory number 57-361-L and 57-361-R)
• Replace damaged parts immediately; must be done by experienced personnel.
• The product is only intended for indoor use.

General Maintenance for gait training Sling:

Read the product label.

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

Storage and transportation

If the walker is not to be used for some time or e.g., during transport, we recommend that the emergency stop button be pressed in. The walker should be transported and stored in -10 ° C to + 50 ° C and in normal humidity, 20% to 80% non-condensing. The air pressure should be between 700 and 1060 hPa. Leftmost symbol indicates storage and transportation. 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 atmo-spheric pressure 700 to 1060 hPa. See also Technical Information below. Leftmost symbol indicates operating condition.

Technical Specifications

Dimensions apply to Walkers with 125 mm castors.

Part No.| Product| Product width| Max user weight| Length| Height| Armrest/ internal dimension
---|---|---|---|---|---|---
56-311| Standard GAS| 78cm| 150kg| 80cm| 90-129cm| 25-50cm
56-301| S GAS| 66cm| 150kg| 79cm| 90-129cm| 30-45cm
56-322| Low GAS| 78cm| 150kg| 80cm| 75-95cm| 25-50cm
56-322-S| Low S GAS| 66cm| 150kg| 79cm| 75-95cm| 30-45cm

Product weight:
Manual 15 kg, Gas 15 kg, Electric 21 kg
”LIFT” denotes suitable handhold for lifting the Walker.

NOTE: At least two people are required  for lifting.

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) should be recycled).

Warranty

For further information or enquiries please contact:
Direct Healthcare Group Sverige AB
Torshamnsgatan 35,
SE-164 40 Kista, Sweden

Tel: +46 (0)8-557 62 200
[email protected]

www.directhealthcaregroup.com

Electrical System – Technical Data

IEC60601-1 3rd revision

Control box + Battery

IEC60601-1 3rd revision

Expected lifetime
The life expectancy of the product is 8 years.

Parts List

1| A B C D| Armrest Knob

Plastic Washer

Washer, Black

| 6| M N| Protective Cover Bolts
---|---|---|---|---|---
2| D E F| Handle & Grip Clamp

Knob

| 7| O P Q R S T U| Wheel frame End bushing Wheel

Bolt Washer Nut

Serrated washer

3|  | Upper frame| 8|  | Locking handle, height adjustment
4| G H I J| Chromium-plated tube Attachment bolt (2 pcs) Serrated washer

End bushing

| 9| A B C D| Gas strut Handle Arm/housing

Bolt, washer (2 pcs), nut (attachment at bottom and top)

5| K L| Frame Sleeve guide| 10| A B

C D E

| Battery shelf & attachment bolts Battery & nut/ bolt (for attachment to battery shelf) Control box TiMOTION

Hand control TiMOTION

Actuator TiMOTION

Spare Parts

Accessories

Table of Symbols

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.

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.
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.

Radiated Fields in close proximity, Immunity test and compliance. Standard: IEC 61000-4-39

Dwell time: 3 sec
Test levels (A/m)| Modulation

Pulse modulation

| Mod. Frequency (kHz)| Test Frequency
8| CW| CW| 30 kHz
65| 50% Duty cycle| 2.1| 134.2 kHz
7.5| 50% Duty cycle| 50| 13.56 MHz
Immunity test| Basic EMC standard or test method| IEC 60601-1-2 Edition 4 Test levels and compliance
---|---|---
Professional healthcare facility environment| Home healthcare environment
Surge| IEC 61000-4-5| ± 0.5 kV, ± 1 kV
Voltage dips| IEC 61000-4-11| 0% UT; 0.5 cycle

At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°

0% UT; 1 cycle and

70% UT; 25/30 cycles. Single phase: at 0°

Voltage Interruptions| IEC 61000-4-11| 0% UT ; 250 / 300 cycle
Conducted disturbanc- es induced by RF fields| IEC 61000-4-6| 6V in ISM bands between

0.15 MHz and 80 MHz 80% AM at 1 kHz

| 6V in ISM and amateur bands between 0.15 MHz and 80 MHz

80% AM at 1 kHz

Dwell time: 3 sec Frequency step size: 1%
Radiated RF Electro- magnetic fields| IEC 61000-4-3| 3 V/m

80 MHz – 2.7 GHz

80% AM at 1 kHz

| 10 V/m

80 MHz – 2.7 GHz

80% AM at 1 kHz

Dwell time: 3 sec Frequency step size: 1%
Electrical fast transients

/ burst

| IEC 61000-4-4| ± 2 kV

100 kHz repetition frequency

RATED Power frequen- cy magnetic field| IEC 61000-4-8| 30 A/m

50 Hz or 60Hz

Electrostatic Discharge (ESD)| IEC 61000-4-2| Contact: ± 8 kV

Air: ± 2 kV, ±4 kV, ± 8 kV, ± 15 kV

Number of discharges: 10 for each polarity

Radiated Radio – Frequency, Proximity fields from wireless communication equipment & compliance. (Dwell time: 3 sec.)

Standard: IEC 61000-4-3

Spot Frequencies

| Test Frequency (MHz)| Band (MHz)| Service| Modulation| Immunity test levels (V/m)
385| 380 to 390| TETRA 400| Pulse modulation 18 Hz| 27
450| 430 to 470| FMRS 460, FRS

460

| FM

± 5 kHz Deviation 1 kHz sine

| 28
710| 704 to 787| LTE Band 13, 17| Pulse modulation 217 Hz| 9
745
780
810| 800 to 960| GSM 800/900, TETRA 800,

iDEN 820,

CDMA 850, LTE

Band 5

| Pulse modulation 18 Hz| 28
870
930
1720| 1700 to

1990

| GSM 800/900, TETRA 800,

iDEN 820,

CDMA 850, LTE

Band 5

| Pulse modulation 217 Hz| 28
1845
1970
2450| 2400 to

2570

| Bluetooth, WLAN, 802.11

b/g/n, RFID 2450, LTE

Band 7

| Pulse modulation 217 Hz| 28
5240| 5100 to

5800

| WLAN 802.11

a/n

| Pulse modulation 217 Hz| 9
5500
5785
Other Identified frequencies| 433| –| –| Pulse modulation 2 Hz| 3
–| 860-960| –| Pulse modulation 2 Hz| 54
2450| –| –| Pulse modulation 2 Hz| 54

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
[email protected]
www.directhealthcaregroup.com

References

• Moving Health Forward | DHG

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