Enraf-Nonius Tree MDR User manual

Brand: Enraf-Nonius

Model: Tree MDR

Type: User manual

Enraf-Nonius Tree MDR is a versatile medical training therapy device designed to offer a flexible and effective way to improve physical rehabilitation. With its user-friendly design and various accessories, it allows for a wide range of exercises targeting different muscle groups and movement patterns. The device's adjustable resistance and range of motion settings enable customized training programs tailored to individual needs and progress.

EN-Tree Pulley MD

EN-Tree M MD

EN109-1410750-46 IFU

June 11, 2020

Instructions for use

Page 2 of 12 EN109-1410750-46 IFU

Table of contents

1 Introduction ...................................................................................................................................................... 3

2 Symbols .............................................................................................................................................................. 3

3 Package contents ............................................................................................................................................ 4

4 Installation ......................................................................................................................................................... 5

5 Intended use and intended user ............................................................................................................... 6

6 Contra-indications .......................................................................................................................................... 7

7 Precautionary instructions ........................................................................................................................... 7

8 Operation ........................................................................................................................................................... 8

9 Maintenance ..................................................................................................................................................... 9

10 Specifications ................................................................................................................................................. 10

11 Contact ............................................................................................................................................................. 11

12 Product liability ............................................................................................................................................. 11

Page 3 of 12 EN109-1410750-46 IFU

1 Introduction

We are pleased that you have purchased the EN-Tree Pulley. The EN-Tree Pulley offers the possibility

to practice in a very flexible way medical training therapy.

When developing and producing the EN-Tree Pulley, much consideration was given to reliability,

safety, user comfort and durability.

2 Symbols

Symbol

Description

Warning or Caution:

Indicates a hazardous situation which, if not avoided, could result in:

a. Death or serious injury to the patient (or)

b. Minor to moderate injury to the patient (or)

c. Damage to the equipment

Type B applied part complying with the specified requirements to provide

protection against electric shock, particularly regarding allowable patient

leakage current and patient auxiliary current.

Temperature Range.

Indicates acceptable temperature range

Humidity Limits.

Indicates acceptable relative humidity

Atmospheric Pressure.

Indicates the range of atmospheric pressure to which the medical device can

be safely exposed.

Waste electrical items that can be recycled.

Indicates the electrical and electronic components of the device can be

recycled and has to be disposed separately.

Keep the device dry

Manufacturer name, address and date of manufacture.

Reference Number or Part Number

Serial Number

Indicates the serial number so that a specific medical device can be

identified.

Indicates that the item is a medical device.

Page 4 of 12 EN109-1410750-46 IFU

Indicates a carrier that contains Unique Device Identifier information.

Product is in conformity with European Council of Medical Device Directive

(93/42/EEC)

Polarity of d.c. power connector

To identify the positive and negative connections (the polarity) of a d.c. power

supply, or the positive and negative connections on a piece of equipment to

which a d.c. power supply may be connected.

3 Package contents

1455.971 EN-Tree Pulley MD

1455.973 EN-Tree Pulley Explosive MD

1455.975 EN-Tree M Standard MD

1455.976 EN-Tree M Explosive MD

Standard accessories

1410.750 Instructions for Use

3443.305 Set of 2 handgrips

Optional accessories

3443.305 Set of 2 handgrips

3443.306 Set accessories for EN-Tree Pulley (consists of 3443.307, 3443.308, 3443.309, 3443.310)

3443.307 Pull Down accessory

3443.308 Lat pulley handgrip

3443.309 Triceps handgrip

3443.310 Ankle strap, 37 cm

3443.313 Leather strap, 73 cm

3447.695 Foot sling

Ordering information

For the ordering data of the EN-Tree Pulley, standard accessories and additional accessories we refer

to the website www.enraf-nonius.com.

Page 5 of 12 EN109-1410750-46 IFU

4 Installation

Inspection

In case of damage from transport is noticed, contact your local distributor.

DO NOT USE the device!

Installation

The EN-Tree Pulley must be installed in such a way that its use is not limited by other objects. Keep at

least 2.50 m free around the unit.

The EN-Tree Pulley or EN-Tree M units must be attached to the wall with suitable fittings. The EN-Tree

Pulley or EN-Tree M must only be mounted on a brick or concrete wall. Position the plugs firmly in the

centre of a brick in case of a brick wall. The fixation must be able to resist a horizontal pulling force of

950 N.

In case of installation of 2 EN-Tree Pulleys, we advise you to place the centre of the EN-Tree Pulley at

2.5 m from both sides of the corner (figure 1).

Figure 1

Do not use the EN-Tree Pulley in “wet rooms”.

Connection of an adapter other than the prescribed charger can adversely affect the safety of the user

and the functioning of the unit, and is therefore not permitted.

Mounting of the Pull Down accessory

Please refer to figure 2 for the mounting of the Pull Down accessory.

The 45 degrees Pull Down accessory is only intended for support during exercising. Never

apply the full body weight to the Pull Down accessory. The maximum admissible weight for

the 45 degrees Pull Down accessory is 50 kilograms (figure 3).

Page 6 of 12 EN109-1410750-46 IFU

Figure 2

Figure 3

5 Intended use and intended user

The EN-Tree Pulley is designed to be used and shall ONLY be used by or under the supervision of

professional users in the field of physical medicine and rehabilitation.

Page 7 of 12 EN109-1410750-46 IFU

6 Contra-indications

Absolute contra-indications

• Myocardial dysfunction in an instable phase

• HNP in the (sub) acute phase (with irradiation and neurological signs)

• Severe osteoporosis

• Acute fractures

• Severe mechanical instability

• Early post-surgical joint modification

Relative contra-indications

• Myocardial dysfunction in a stable phase

• HNP in the sub-acute phase (without irradiation and neurological signs)

• Mild osteoporosis

• Late post-surgical joint modification

• Tumours

• Inflammations in the involved area

• Non desired articular load in the involved area (e.g. with M. Osgood-Schlatter, bursites, etc.)

• Non desired ligamentous load in the involved area (e.g. sprain with hydrops)

• Non desired soft tissue load in the involved area (e.g. with severe atrophy)

• Cardiovascular restrictions

• Pulmonary restrictions

• Psychological restriction

• Pain of such cause that movement would not relief

7 Precautionary instructions

Should the use of this device lead to an undesirable event such as death or serious injury to the

user, the manufacturer and the competent authority of the Member State MUST be informed

without delay!

Always use the original Enraf-Nonius accessories that are meant for this product.

The EN-Tree Pulley should be operated or used by one person at once.

Limbs must be kept clear from moving parts.

Clean the cuffs after usage.

During exercising hands must be kept clear from the guiding bars of the weights.

Never re-set weights during exercising.

Avoid the cord grating along sharp paths.

When selecting a weight, always push the pin in to its full extent.

Keep spectators away from the pulley when it is in use (at least 1 meter).

When using the latissimus grip, first the load must be selected, before the grip is mounted. If

you change the weight in the meantime you have to hold the upperweight to prevent the grip

from falling down.

The 45 degrees Pull Down accessory is only intended for support during exercising. Never apply

the full body weight to the Pull Down accessory. The maximum admissible weight for the 45

degrees Pull Down accessory is 50 kilograms.

When used by children, supervision by a knowledgeable (para)medic is obligatory. At all times

keep children away from the equipment when no supervision is at hand!

A correct bio mechanical positioning of the body is necessary.

Page 8 of 12 EN109-1410750-46 IFU

When the EN-Tree Pulley is not used in the correct way, injury may occur. This device should

be used only under the continued supervision of a physician or licensed practitioner.

In case of damage from transport is noticed, contact your local distributor.

DO NOT USE the device!

Do not use this device in so called “Wet Rooms” (hydrotherapy rooms).

8 Operation

• For the sequence if training therapy we direct you

to the therapy guides and reference books

published on this matter.

• The height of the cord extension can be adjusted

with part 1 (fig. 4).

• The length of the unloaded cord can be adjusted

with part 2 (fig. 4).

• The load on both cord ends together, corresponds

with the number on the weights in kgs. The last

remark is not applicable for the Explosive version.

• In order to limit the range of motion, you can use

the upper block (part 3 in fig. 4).

Figure 4

Page 9 of 12 EN109-1410750-46 IFU

9 Maintenance

Cleaning

• The steel undercarriage can be cleaned with a damp cloth and a (nonabrasive) liquid household

cleaner

Maintenance

• To keep the leather parts flexible, you can use leather fat.

• After some time, the sliding and turning parts could run less smoothly, because of pollution and

dehydration. You can re-grease the Pulley with ball bearings grease (which you can obtain at a

bicycle shop). If required, the guiding bars of the weights can be greased with a little oil.

• Check the cord and the cord fixations regularly for signs of wear. In case of excessive wear and

tear, the cord must be replaced and use of the EN-Tree Pulley is not recommended until the cord

has been replaced.

• In order to obtain spare parts, please contact your supplier.

• We recommend to have the EN-Tree Pulley checked yearly by authorized personnel of Enraf-

Nonius or by its authorized distributor. The manufacturer will not be held responsible for the

results of maintenance or repairs by unauthorized persons!

Expected service lifetime

This device will remain suitable for its intended use as long as it is subjected to yearly maintenance by

a qualified service engineer as described in the service manual.

The service engineer will decide whether the device is suitable for use according to the specifications.

End of life

Your EN-Tree Pulley contains materials which can be recycled and/or are noxious for the environment.

At the end of the duration of life, specialized concerns can take apart the EN-Tree Pulley and sort out

the noxious materials and materials for recycling. By doing so you contribute to a better environment.

Please ensure that you are well informed of the local rules and regulations regarding

the removal of equipment and accessories.

Page 10 of 12 EN109-1410750-46 IFU

10 Specifications

Technical data

EN-Tree Pulley MD and EN-Tree M Standard MD:

Dimensions

218 x 30 x 33 cm (HxWxD)

Weight

60 kg

Height adjustment for rope

0 – 200 cm

Adjustable weight/load

1 kg – 24 kg

Effective weight/load with one cord end

0.25-0.5-0.75-1-2-3-4-5-6-7-8-9-10-11-12 kg

Effective weight/load with two cord

ends combined

0.5-1-1.5-2-4-6-8-10-12-14-16-18-20-22-24 kg

EN-Tree Pulley Explosive MD and EN-Tree M Explosive MD:

Dimensions

218 x 39 x 35 cm (HxWxD)

Weight

97 kg

Height adjustment for rope

0 – 200 cm

Adjustable weight/load

2 kg – 54 kg

Effective weight/load with one cord end

0.33-1-1.6-2.3-4.3-5-5.6-6.3-7-7.6-8.3-9 kg

Effective weight/load with two cord

ends combined

0.66-2-3.33-4.66-6-7.3-8.6-10-11.3-12.6-14-15.33-

16.66-18 kg

Technical modifications reserved

Safety and performance standards

Medical device classification

Class I (93/42/EEC)

This equipment complies with all requirements of the

Medical Device Directive (93/42/EEC).

For EN-Tree M Standard MD and EN-Tree M Explosive MD:

Safety class according to IEC 60601-1

Class II B

Applied parts

Type B Applied part

Environmental conditions

Environmental conditions for transport and storage

Environmental temperature:

–10° till +70° C

Relative humidity:

10 to 90% (non-condensing)

Atmospheric pressure:

800 till 1060 hPa

Environmental conditions normal use

Environmental temperature:

10° till 40° C

Relative humidity:

10 to 90 % (non-condensing)

Atmospheric pressure:

800 till 1060 hPa

Page 11 of 12 EN109-1410750-46 IFU

11 Contact

For assistance, please visit our website http://www.enraf-nonius.com

The latest version (in electronic or printed format) of this Instructions for Use can be obtained free of

charge from our website www.enraf-nonius.com or by contacting distributor or by calling the

telephone number: +31-(0)10-2030600. The Instructions for Use will be sent (free of charge) to you

within 7 (seven) calendar days.

12 Product liability

A law on Product Liability has become effective in many countries. This Product Liability law implies,

amongst other things, that once a period of 10 years has elapsed after a product has been brought

into circulation, the manufacturer can no longer be held responsible for possible shortcomings of the

product.

To the maximum extent permitted by applicable law, in no event will Enraf-Nonius or its suppliers or

resellers be liable for any indirect, special, incidental or consequential damages arising from the use of

or inability to use the product, including, without limitation, damages for loss of goodwill, work and

productivity, computer failure or malfunction, or any and all other commercial damages or losses,

even if advised of the possibility thereof, and regardless of the legal or equitable theory (contract, tort

or otherwise) upon which the claim is based. In any case, Enraf-Nonius entire liability under any

provision of this agreement shall not exceed in the aggregate the sum of the fees paid for this

product and fees for support of the product received by Enraf-Nonius under a separate support

agreement (if any), with the exception of death or personal injury caused by the negligence of Enraf-

Nonius to the extent applicable law prohibits the limitation of damages in such cases.

The opposing party (product’s user or its representative) shall disclaim Enraf-Nonius from all claims

arising from third parties, whatever nature or whatever relationship to the opposing party.

EN109-1410750-46

Enraf-Nonius B.V.

Vareseweg 127 | 3047 AT | Rotterdam | The Netherlands

Tel: +31 (0)10-20 30 600 | [email protected]

Enraf-Nonius Tree MDR User manual

Enraf-Nonius Tree MDR User manual

Enraf-Nonius Tree MDR User manual

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