Zimmer CITrac User manual

Instructions for Use
clTrac
EN

Illustrations
Front and rear of the device
Fig. 1
Front of the device
1. Touch screen
2. Central control knob
3. Traction cord
Fig. 2
Rear of the device
4. Swivel head
5. Main switch
6. Power connector
7. Label clTrac
8. Jack plug (Patient interrupt cable port)
9. USB connector (Firmware update port)
10. Traction Cable
1
2
3
4
5
6
7
8
9
10

Illustrations
Accessories
Fig. 3
Fig. 4
Patient interrupt button
Mains cable

Illustrations
Screens
Fig. 5
Displays / Therapy A Graphical display of the settings
Screen B Store button
C Status bar
D Parameter settings
Fig 6
Displays / Program E Switch to Programs
Screen F Switch to Favorites
G Switch to Manual
H Switch to Settings
I Back button
J List of Indications
D
A
E
F
G
H
B
C
I
E
J

Explanation of Symbols
In the instructions for use this symbol indicates “Danger” with regard to possible risks
to people.
In the instructions for use this symbol indicates "Caution" with regard to possible
damage of the device.
Applied part type B
Operation instructions
Follow instructions for use.
Protective earth (ground)
Switch on/switch off symbol
Serial number
Article number
LOT Number
Medical Product
Manufacturer
Date of manufacture
Keep dry, ISO 7000-0626

Explanation of Symbols
Fragile, handle with care
Disposable packaging materials
Keep away from sunlight, ISO 7000-0624
Temperature limit, ISO 7000-0632
Storage and Transport air humidity range
Storage and Transport Air pressure range
This way up
CE mark including the number of the notified body.
Disposal of electrical and electronic equipment as well as used batteries and
accumulators.
This product must not be disposed of with household waste.

Contents
Illustrations
Front / Rear of the Device
Accessories
Screens / Displays
Explanation of Symbols
Page
1.
Intended Use / Indications / Contra-indications
1
1.1.1.
2.
Side Effects
3
1.1.2.
3.
Application Information
4
1.1.1.
4.
Warnings
5
1.1.1.
5.
clTrac in brief
6
1.1.2.
6.
Device Set Up
7
1.1.1.
7.
Settings
9
1.1.2.
8.
Operation Instructions
11

Contents
9.
Technical Information
20
10.
Cleaning / Disinfection
21
1.1.3.
11.
CE-Mark
22
1.1.4.
12.
Scope of Delivery and Accessories
23
1.1.5.
13.
Device Combinations
24
14.
Safety and Maintenance
25
1.1.6.
30
15.
Functional Test
26
16.
Safety Check / Metrological Control
27
1.1.7.
17.
Error Messages / Troubleshooting / Disposal
28
18.
Manufacturer’s EMC declaration
32
1.1.8.
Valid for TRA-01 devices. This device is further on in this manual called clTrac
This instructions for use is an integral part of the device. It must be stored with the device and kept accessible at all times for anyone
authorized to operate this device.
The instructions for use is valid as of April 2022.

Intended use / Indications / Contra-indications
1
Page 1
Intended use
The clTrac is a traction device for separating the cervical, thoracic or lumbar
vertebrae along the inferosuperior axis of the spine by using a mechanical force.
Indications
Traction is indicated for general clinical use in case of musculoskeletal or
neurological impairments of the spine. The objective is to relieve peripheral
radiation/sciatica and pain. Traction is a widely used treatment for neck and low back
pain and it is typically provided in combination with other treatment modalities and an
exercise program.
The clTrac may be used to relieve peripheral radiation/sciatica and pain associated
with
•Protruding discs
•Spinal root impingement
•Bulging discs
•Hypomobility
•Herniated discs
•Degenerative joint disease
•Degenerative disc disease
•Facet syndrome
•Posterior facet syndrome
•Compression fractures
•Acute facet problems
•Joint pain
•Radicular pain
•Discogenic pain
•Prolapsed discs
Contra-indications
Traction therapy is contra-indicated in patients with:
•Structural disease secondary to tumor or infection
•Patients with vascular compromise
•Any condition for which movement is contraindicated
•Patients with acute strains, sprains, and inflammation which would be
aggravated by traction therapy
•Patients with joint instability of the spine
•Pregnancy
•Osteoporosis
•Hiatus hernia
•Claustrophobia
•Cardiac or pulmonary problems
Intended user
Trained health care practitioners, such as physicians, physiotherapist and nurses.

Intended use / Indications / Contra-indications
1
Page 2
Patient group /
intended population
The intended patient group is children, young adults and adult patients considering
the contra indications and only when they are capable to express themselves orally
with respect to the effects of the traction therapy
Applied parts
The patient interrupt button is a type B applied part.
The traction cord is intended to be attached to hip and thoracic traction harness /
belts that are sold and certified separately
Any serious incident that has occurred in relation to the device should be reported to
the manufacturer and the competent authority of the Member State in which the user
and/or patient is established.

Side Effects
2
Page 3
Side effects
Spinal traction can cause minor muscle spasms.
Direct after the treatment the patient can experience some dizziness.
If traction belts are applied directly to bare skin, skin irritation may occur.
Short after the treatment patients can experience some pain in the treated areas.

Application Information
3
Page 4
Before using the device on a patient, the user should become acquainted with the
operating instructions and individual treatment methods as well as the indications /
contraindications, warnings and application information. Additional sources of
information about types of therapy should be consulted.
Before use, ensure that the device is powered via a properly earthed plug with a
grounded outlet (electrical installation according to DIN VDE 0100 Part 710). The
device must only be operated with the supplied power cord. The power cord must be
protected against mechanical stress.
Operation of this equipment in the vicinity of strong electromagnetic fields (e.g.
tomographs, x-ray or diathermy equipment) may interfere with the operation of the
device. Please keep a safe distance of several meters.
clTrac is not suitable for use in areas with an explosive, flammable or combustive
environment.
To avoid the risk of electric shock; the device´s main plug must be disconnected
from the mains supply before performing any maintenance, service or reprocessing
activities.
Inspect the device before to use. If there is any damage, it must not be used.
Only a traction bank provided or recommended by Zimmer MedizinSysteme GmbH
must be used.
Only accessories provided or recommended by Zimmer MedizinSysteme GmbH
must be used.
WARNING: Use of accessories, transducers and cables other than those specified
or provided by the manufacturer of this equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this equipment
and result in improper operation
WARNING: Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than 30 cm (12
inches) to any part of the clTrac, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment could result
The clTrac must be placed on a level ground

Warnings
4
Page 5
User of the clTrac must be trained in how to use the device properly and have the
appropriate skills.
The device is intended to be used exclusively by medical professionals.
The clTrac may not be used on patients who cannot express themselves orally with
respect to the effects of the traction therapy.
Any treatment instructions regarding treatment location, duration and intensity
require medical knowledge and should be given by authorised physicians, therapists
and health paraprofessionals. It is imperative that these instructions are followed.
The patient must not be left unattended during therapy.
No modification of this equipment is allowed. Only use specified products with the
equipment.
Do not touch the patient while replacing the fuse.
The use in wet areas is not permitted and may in case of non-compliance lead to
considerable damage to the device and endanger both the patient and the user.
Dispose packaging materials properly. Make sure that it is not accessible to children.
Do not push the rope into the device because the mechanism may get jammed.
Inspect the swivel head for damage before every use.

clTrac in brief
5
Page 6
What is the clTrac
The clTrac is a modern, innovative and easy to use traction unit that offers static
and intermittent traction.
What does the clTrac
do?
Spinal traction is a form of decompression that relieves pressure on the spine.
What are the
advantages of
clTrac?
Traction is a non-surgical, non-invasive and non-pharmaceutical treatment to
relieve pain and correct spine problems.
What are other
advantages of
clTrac
A large color display showing all therapy-related parameters.
Modern touch operation as well as individual programmable parameters ensure
maximum convenience for the user.
The integration of a patient interrupt button guarantees patient safety.
Notice:
The device is intended to be used exclusively by medical professionals
(e. g. physicians, therapists, medical paraprofessionals).

Device Set Up
6
Page 7
Installing the traction
device
After the transport and before switching on the device, make sure that the device is
properly fixed to the traction table. Always follow the installation instructions from the
traction table mounting bracket. If not present, follow the instructions below:
Function of holes on device baseplate:
A. Alignment hole with ø9.6mm
B. Alignment set pin holes with ø6.5mm
C. M8 Screw-holes for couch mount
D. M8 Screw holes for stand mount or mounting bracket
Only a traction bank provided or recommended by Zimmer MedizinSysteme GmbH
must be used.
Install device on
therapy table /
mounting bracket
Hole A of the device fix on pin A of the installing plate (only on specific traction tables
available)
Turn the device to setting position as intended (there are 3 positions for setting)
Fix the clTrac to the traction table plate by 4 M8 hand-screws.

Device Set Up
6
Page 8
Install device on
mounting bracket
Lock M8 stud to screw hole D. (only for some specific traction couch)
Put in the universal mounting bracket to stud
Fix to traction couch plate by 4 hand-screws.
Connect the power
cord
Connect the mains cable to the socket (6) on the device and connect it to the mains.
Connect the patient
interrupt button
Plug in the patient interrupt button into the jack plug (8).
Notice:
The patient interrupt button is essential for proper functioning of the device. If it is not
connected, or if it is malfunctioning, the unit will not work
Notice:
The device may only be connected to sockets with protective earth.
Switch on the device
Switch on the device with the power switch (5)
Before switching on the device, pull the traction cord 1,5 meter out of the clTrac. If
the traction cord shows any visible damage or the knot is deformed, stop the
treatment immediately and contact Zimmer MedizinSysteme GmbH or your local
distributor
Never try to repair the traction cord yourself
Improperly tied knots may result in injuries. Do not try to re-tie the knot unless you
are properly trained. The used knot is the ‘double 8 loop knot’.
If the traction cord needs to be replaced contact Zimmer MedizinSysteme GmbH or
your local distributor
The traction device and traction table must always be placed on level ground.

Settings
7
Page 9
Start-up screen
Once the device has been switched on and the self-test performed, the start-up
screen opens
Standard screen
After the self-test has been performed, clTrac goes automatically in the
standard screen.
In the settings menu, the factory default settings can be individually
changed and adjusted.
Selecting configuration
Pressing the Settings button (A) immediately switches to the configuration
menu.
(B) Brightness
Adjust the brightness by using the central control knob.
(C) Version
Pressing the ‘Version’ button opens a window with information about the current
software version.
(D) Language
Switch between the language
(E) Start page
Switch between Programs, Favorites or Manual as start page.
A
B
C
D
E
F
G
H
I

Settings
7
Page 10
(F) Units
Switch between metric or imperial unit system.
(G) Volume
Adjust the volume by using the central control knob.
(H) Set to default
Pressing the ‘Set to default’ button restores the default factory settings.
(I) Back
Pressing the ‘Back’ button opens the previous screen.

Operation Instructions
8
Page 11
Device description
The clTrac consist of a main body with swiveling head, a traction cord and a patient
interrupt button.
Notice:
An operation is only possible with a plugged-in patient interrupt button possible.
Notice:
The rated power for this equipment is 300W
Repair, expansion and installation of equipment shall not be performed by anyone other
than the specialized personnel authorized by the manufacturer. Arbitrary
disassembling/assembling of equipment by the user is absolutely prohibited.
Visual inspection traction cord
Before switching on the device, pull the traction cord 1,05 meter out of the clTrac.
Inspect if the traction cord (3) has any visual damage. When damage is found the device
needs service, please contact Zimmer MedizinSysteme GmbH or your local distributor.
Inspection hand screws fixation device
Before switching on the device, check the hand screws on the bottom of the clTrac
if they are fixed.
The patient must never be left unattended during treatment.
Notice:
Prolonged wear on the cord can cause it to break, which leads to sudden release of
traction pressure on the patient.
Patient preparation
Position the patient on an appropriate type of (traction) treatment table. Follow the
instructions supplied with the table.
Use an appropriate traction harness by following the instructions supplied with the
harness.
Make sure the harness fits the patient according the manufacturer’s instructions.
Pull the traction cord out of the clTrac and connect the harness to the traction cord.
Notice:
Be careful with long hair and pulling up the traction cord

Operation Instructions
8
Page 12
Starting
Switch on the device with the main switch (see Fig 2).
Press the “Manual” button (1) to open the ‘Manual’ screen. Manual treatment or pre-
programmed treatments can be selected from here.
Opening a program
Press the ‘Programs’ tab (2) in the taskbar on the right side of the screen to open the
‘Programs’ screen.
Programs
The user can start a treatment by using one of the 6 pre-programmed programs.
Select the desired treatment program by pressing on the appropriate row. After selecting
on the Programs, the treatment screen will pop-up with accordingly pre-set values.
1
2