Proxomed Compass 530 User manual

compass®530
User Manual
compass®530

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In this user manual you will find information on the following products:
Lower extremities:
compass® 530 Ab-/Adduction
compass® 530 Leg Extension/Curl
compass® 530 Leg Extension
compass® 530 Leg Curl

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compass® 530 Leg Press
compass® 530 Hip Extension
compass® 530 Multi Hip

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Hull:
compass® 530 Lateral Flexion
compass® 530 Trunk Extension/Flexion
compass® 530 Trunk Extension
compass® 530 Trunk Flexion

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compass® 530 Trunk Rotation

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Upper extremities:
compass® 530 Chest Press/Rowing
compass® 530 Chest Press
compass® 530 Butterfly/Butterfly Reverse
compass® 530 Rowing

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compass® 530 Pulldown/Dip
compass® 530 Pulldown
compass® 530 Dip

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1Foreword
Dear Customer,
We would like to thank you for your confidence that you have chosen
products of proxomed Medizintechnik GmbH with your purchase and that
you share and support our vision of a healthy society. We are pleased that
our devices are in therapeutic use with you and support many patients in
their rehabilitation.
For more than 30 years, our customers worldwide have relied on our medical testing and training
systems. Our offerings as a full-service provider in active rehabilitation have grown continuously. In
addition to our core market in Germany, we are now represented in over 40 countries around the world
with our products and services for the benefit of a healthy society.
This success is based on a holistic understanding of the needs of our customers and their clients.
Maximum therapeutic success and personal quality of life improvement for all people are our incentive
in the changing healthcare system of the future.
For the health of your patients and the long-lasting use of our products, please read this manual carefully
with all important information for a safe and correct use of the devices.
You can also take advantage of our favorable maintenance and support contract offers, which ensure
that the value of the device technologies and software packages you use for your company is maintained
over the long term in accordance with the applicable Medical Device Operator Ordinance. If you have
any questions, please contact our service department.
Please keep the manual in a safe place and always have it available for further use.
Marcus Melching
CEO proxomed Medizintechnik GmbH

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Table of contents
1Foreword.................................................................................................................................... 8
2Legend...................................................................................................................................... 13
2.1 Safety instructions......................................................................................................................................................13
3Safety instructions .................................................................................................................. 14
3.1 Marking on the device.............................................................................................................................................. 14
3.2 Applied symbols for transport .............................................................................................................................. 15
3.3 Liability notice..............................................................................................................................................................16
3.4 Intended use.................................................................................................................................................................16
3.5 Indications and contraindications........................................................................................................................17
3.6 Patient target group..................................................................................................................................................17
3.7 Clinical benefit ............................................................................................................................................................. 17
3.8 Responsible operation.............................................................................................................................................. 17
3.9 Safety regulations.......................................................................................................................................................17
3.10 Usage note Butterfly/Butterfly Reverse .............................................................................................................18
3.11 Protective cladding .................................................................................................................................................... 18
3.12 Combination with other products .......................................................................................................................18
3.13 Side effects and residual risks ...............................................................................................................................18
3.14 Incident reporting ...................................................................................................................................................... 19
4Storage, transport and installation ....................................................................................... 20
5Commissioning........................................................................................................................ 22
6Training tips............................................................................................................................. 23
7Device descriptions Lower extremities ................................................................................. 25
7.1 compass® 530 Ab-/Adduction ............................................................................................................................. 25
Intended use.......................................................................................................................................................25
Indications ........................................................................................................................................................... 25
Specific patient positioning.......................................................................................................................... 25
7.2 compass®530 Leg Extension/Curl.......................................................................................................................26
Intended use.......................................................................................................................................................26
Indications ........................................................................................................................................................... 27
Specific patient positioning.......................................................................................................................... 27

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7.3 compass® 530 Leg Extension................................................................................................................................ 28
Intended use.......................................................................................................................................................28
Indications ........................................................................................................................................................... 28
Specific patient positioning.......................................................................................................................... 28
7.4 compass ®530 Leg Curl...........................................................................................................................................29
Intended use.......................................................................................................................................................29
Indications ........................................................................................................................................................... 29
Specific patient positioning.......................................................................................................................... 30
7.5 compass® 530 Leg Press.........................................................................................................................................31
Intended use.......................................................................................................................................................31
Indications ........................................................................................................................................................... 31
Specific patient positioning.......................................................................................................................... 31
7.6 compass® 530 Hip Extension................................................................................................................................32
Intended use.......................................................................................................................................................32
Indications ........................................................................................................................................................... 33
Specific patient positioning.......................................................................................................................... 33
7.7 compass® 530 Multi Hip.........................................................................................................................................33
Intended use.......................................................................................................................................................33
Indications ........................................................................................................................................................... 34
Specific patient positioning.......................................................................................................................... 34
8Device descriptions Hull ......................................................................................................... 36
8.1 compass® 530 Lateral Flexion...............................................................................................................................36
Intended use.......................................................................................................................................................36
Indication ............................................................................................................................................................. 36
Specific patient positioning.......................................................................................................................... 36
8.2 compass® 530 Trunk Extension/Flexion ...........................................................................................................37
Intended use.......................................................................................................................................................37
Indication ............................................................................................................................................................. 37
Specific patient positioning.......................................................................................................................... 37
8.3 compass® 530 Trunk Extension............................................................................................................................ 38
Intended use.......................................................................................................................................................38
Indication ............................................................................................................................................................. 38

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Specific patient positioning.......................................................................................................................... 39
8.4 compass® 530 Trunk Flexion.................................................................................................................................39
Intended use.......................................................................................................................................................39
Indication ............................................................................................................................................................. 40
Specific patient positioning.......................................................................................................................... 40
8.5 compass® 530 Trunk Rotation..............................................................................................................................41
Intended use.......................................................................................................................................................41
Indication ............................................................................................................................................................. 41
Specific patient positioning.......................................................................................................................... 41
9Device descriptions Upper extremities ................................................................................. 43
9.1 compass® 530 Chest Press/Rowing.................................................................................................................... 43
Intended use.......................................................................................................................................................43
Indication ............................................................................................................................................................. 43
Specific patient positioning.......................................................................................................................... 43
9.2 compass® 530 Chest Press.....................................................................................................................................44
Intended use.......................................................................................................................................................44
Indication ............................................................................................................................................................. 44
Specific patient positioning.......................................................................................................................... 44
9.3 compass® 530 Butterfly/Butterfly Reverse.......................................................................................................45
Intended use.......................................................................................................................................................45
Indication ............................................................................................................................................................. 45
Specific patient positioning.......................................................................................................................... 46
9.4 compass® 530 Rowing.............................................................................................................................................47
Intended use.......................................................................................................................................................47
Indication ............................................................................................................................................................. 47
Specific patient positioning.......................................................................................................................... 47
9.5 compass® 530 Pulldown/Dip ................................................................................................................................48
Intended use.......................................................................................................................................................48
Indication ............................................................................................................................................................. 48
Specific patient positioning.......................................................................................................................... 48
9.6 compass® 530 Pulldown .........................................................................................................................................49
Intended use.......................................................................................................................................................49

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Indications ........................................................................................................................................................... 49
Specific patient positioning.......................................................................................................................... 49
9.7 compass® 530 Dip..................................................................................................................................................... 50
Intended use.......................................................................................................................................................50
Indication ............................................................................................................................................................. 50
Specific patient positioning.......................................................................................................................... 50
10 General training settings ........................................................................................................ 52
11 Maintenance, cleaning, servicing, disposal........................................................................... 54
12 Accessories............................................................................................................................... 56
13 Technical data.......................................................................................................................... 58
13.1 Lower extremities .......................................................................................................................................................58
13.2 Hull ...................................................................................................................................................................................59
13.3 Upper extremities .......................................................................................................................................................60
14 Warranty .................................................................................................................................. 62

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2Legend
These operating instructions are part of the product and must be kept safe and accessible
throughout the entire service life. In the event of a change of ownership, the operating
instructions must be handed over to the new owner. If supplements to these operating
instructions are supplied, they must be added to the document.
2.1 Safety instructions
The safety instructions presented in the operating instructions are categorized as follows:
Safety note
Meaning
WARNING
WARNING
•Indicates a potentially dangerous situation.
•If the situation is not avoided, death or serious injury may
result.
CAUTION
CAUTION
•Indicates a potentially dangerous situation.
•If the situation is not avoided, an injury may result.
ATTENTION
ATTENTION
•Indicates a potentially harmful situation.
•If the situation is not avoided, the device may be
damaged.

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3Safety instructions
3.1 Marking on the device
Figure
Description
Reference
Observe operating instructions
EN ISO 15223-1
Manufacturer, name, address, year of
manufacture
EN ISO 15223-1
123
CE Mark
EU 2017/ 745
Serial number
EN ISO 15223-1
Unique Device Identification
EU 2017/ 745
Medical Device
Multi-year inspection sticker
Next test date
(marked by perforation)
EN 62353
Nameplate
Identification of the manufacturer, address, year
of manufacture, device designation, serial
number, UDI number as well as device-specific
information
EU 2017/ 745

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Follow instructions
Is additionally attached to devices with
electr. components
ISO 15223-1
3.2 Applied symbols for transport
Figure
Description
Reference
TOP - top here
-
DO NOT stack
-
Protect from moisture
-
Temperature range
ISO 15223-1
Humidity
ISO 15223-1

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3.3 Liability notice
The device has been built according to the current state of the art and recognized safety regulations.
Nevertheless, inadmissible misuse may result in hazards to persons and the device.
No design or development changes may be made to the device. The installation of additional
components or the removal of components is not permitted. The device may only be used if it is in
perfect working order and in accordance with the intended use described.
3.4 Intended use
The equipment is manufactured according to the international standards EN ISO 20957-1 and EN ISO
20957-2 as class S (studio); it is intended for commercial use e.g. in health-oriented fitness facilities or
physiotherapy practices for use on patients*.
Prior to the start of the first training session, the patient(s) will be briefed by qualified personnel.
Training with patients may only be performed under therapeutic supervision.
The device may only be used by adults (14 years and older); unsupervised children must be kept away
from the device.
The application is done in a sitting position.
The application is made only with intact skin.
If you feel unwell or have sudden symptoms, please stop training immediately and consult a doctor if
necessary.
To avoid injury, apply in tight-fitting clothing; tie up open, long hair if necessary.
compass®devices are intended for indoor use only.
When using the devices with the smart assist option outside the German-speaking area, English
language skills are required for operation.
In case of deviations from the intended use, the manufacturer is not liable for damages.
CAUTION
Before starting their first workout, beginners and returners over the age of 45,
as well as people with existing illnesses and health problems, should consult a
doctor.

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3.5 Indications and contraindications
The indications for the use of the devices in therapy are shown in chapter 7 of the respective device.
The devices are contraindicated and must not be used for the conditions listed below:
•Febrile diseases
•Current pain at rest or during activity, as well as acute health complaints
•Existing pain in the musculoskeletal system, including after stretches, strains, torn muscle
fibers, sprains and disc protrusions
•Fresh fractures
•Osteoporosis in continued stages (grade 2 and 3)
•Hypertension in continued stages (grade 2 and 3 according to WHO)
•Artificial joint replacement at the knee and/or hip joint with unstable anchorage
•Severe neurological diseases with a tendency to muscle spasms
•Abdominal wall or inguinal hernia
•Pregnancy from the 2nd trimester
•Heart failure and coronary heart disease. Patients with high blood pressure may only use the
device after consultation with their physician.
3.6 Patient target group
The devices are intended for professional use in healthcare facilities, such as orthopedic and
physiotherapy departments in hospitals, rehabilitation clinics, etc. Depending on the indication, patient's
health condition and treatment goal, the devices can be used in any phase of rehabilitation.
3.7 Clinical benefit
compass®530 devices support physiotherapeutic interventions. The clinical benefit for the patient is the
complementary use of the devices and the resulting improved muscle stabilization.
3.8 Responsible operation
These operating instructions are intended for the operator and the qualified personnel. All persons
working with the device must be trained in its use and must have read and understood the operating
instructions including the safety chapter.
Personnel must be informed before therapy begins and at regular intervals about the nature and scope
of activities and about possible hazards, such as any warnings.
Instruction on the equipment (therapist, trainer, fitness trainer) and monitoring (therapist, sports
therapist, fitness trainer) may only be carried out by trained specialists. Authorization of the operator is
required.
Adjustments must not be operated under load. Before each adjustment, make sure that there is no load
due to a lifted weight block. This may impair the permanent functionality of the components.
3.9 Safety regulations
The device may only be used in technically perfect condition in the intended use. In the event of defects
or malfunctions, please block the device and contact the manufacturer's service department.

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It must be ensured, especially when changing the position of the unit without disassembly, that it stands
securely on level ground.
The protective cladding must not be removed. The device may only be operated with the protective
cladding mounted.
The warranty becomes void if modifications are made to the device or electronic devices for control and
measurement are attached that have not been carried out by specialist personnel authorized by the
manufacturer.
Defective parts of the device must be replaced immediately - in this case, it is advisable to stop using
the device until repairs have been made. Use only original accessories, otherwise no liability will be
accepted.
The device may only be opened by proxomed service or authorized personnel.
Do not reach with your hands between the moving bearings/rollers.
3.10 Usage note Butterfly/Butterfly Reverse
CAUTION
After adjusting the arm pads, make sure that the sliding block is completely guided in its
groove. Then tighten the clamping lever. If the sliding block is not completely guided in
its groove, the entire force applied during training will be applied to the fixing screw.
Breakage of this screw cannot be ruled out then.
3.11 Protective cladding
The cladding of the compass® 530 equipment is made of plastic in frosted glass design. The training
devices only comply with the legal requirements for training operation when fitted with protective
cladding.
The protective cladding fitted by the manufacturer must therefore not be removed or modified, as
otherwise the standards on which training operations are based will not be complied with.
3.12 Combination with other products
compass®530 devices can be optionally equipped with the smart assist accessory. smart assist is an
active medical device from proxomed Medizintechnik GmbH that contains software. smart assist was
developed and tested according to EN 60601-1.
3.13 Side effects and residual risks
The devices are developed in such a way that no critical side effects can occur. Occasional side effects,
such as muscle soreness and joint pain, may occur, usually after incorrect ergonomic adjustment or after
too intensive training. These symptoms should subside spontaneously after a few days.

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3.14 Incident reporting
Please report any clinical events that occurred during and immediately after use of the device directly to
the manufacturer at the address: vigilan[email protected] .

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4Storage, transport and installation
The devices are usually delivered completely assembled. In rare cases, it may be necessary to ship the
units partially disassembled for transport reasons. In these cases, please use the corresponding assembly
instructions at the service s[email protected] and follow the instructions given there!
Surroundings
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Only in dry rooms free from seawater air (>65% humidity).
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Avoiding temperatures below 5 °C and above 45 °C.
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Avoid placing the units in heavily frequented rooms or near doors and
passageways.
Substrate
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The bearing capacity of the substrate must be according to the weight
of the device.
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Level and impact-resistant surface that can withstand the load of the
device and the maximum permissible body weight of the user of 200 kg.
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Small unevenness of the floor can be compensated for by means of the
adjustable feet which can be attached to the unit.
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Or a level surface must be created by using suitable shim material made
of shims or heavy-duty plastic.
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The balancing materials should not be susceptible to rust.
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When changing the position without disassembling the training device,
make sure that the device is standing securely on level ground.
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For PVC floors: the rubber sheets may cause reactions with the PVC floor,
in this case use appropriate cork sheets.
Setting up the
device
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Avoid hard, impact-like contact with the equipment.
●
Compensation of unevenness via adjustable feet, which can be adjusted
in your height. Alignment with a spirit level.
●
Protect the devices from shocks, scratches and moisture.