Zimmer PhySys User manual

Instructions for Use
PhySys
EN

Illustrations
Front of the device and transducers
Fig. 1
Selection and
operating elements
1Mains switch
2Slot for SD card
3Intensity regulator channel I
4Display
5Intensity regulator channel II
Fig. 2
Transducers
17 Ultrasound transducer, large, 5 cm²
18 Ultrasound transducer, small, 1 cm²
3
5
4
1
2
17
18

Illustrations
Back of the device
Fig. 3
Ports
6
Port for ultrasound transducer0.8/2.4 MHz
7Port for patient cable channel II
8Connection for power cable
9Port for patient cable channel I
10 Port for ultrasound transducer0.8/2.4 MHz
11 Port without function
12 Identification plate
6
7
8
9
10
11
12

Illustrations
Screens / display
Fig. 5
Display views
13
Status line
14 Buttons on the screen
15 Heading
16 Navigation menu
Fig. 6
Navigation menu
(A) Home
Switch to start-up screen
(B) Back
Moves one step back
(C) Scroll forwards
Goes forward one page
(D) Scroll backwards
Goes back one page
(E) Memory
Switch to memory
(F) Indications
Switch to indication menu
(G) Programmes
Switch to the program list
(H) Favourites
Switch to favourites
(I) Electrotherapy
Switch to electrotherapy program list
(J) Ultrasound
Switch to ultrasound program list
(K) Combined
Switch to combined program list
(L) Vacuum
Switch to the vacuum screen
16
15
14
13
B
A
C
D
E
F
G
H
I
J
K
L

Explanation of symbols
In the instructions foruse thissymbol indicates “Danger”.
Caution
!
In the instructions for use thissymbol indicates “Caution“with regard topossible
damage of the device.
Applied part type BF
Instructions for use
Follow instructions for use.
Serial number
Item number
Manufacturer
Date of manufacture
This symbol pointsout hazardous areas on the device.
Interval operation30 minutes on, 10 minutes off

Content
Illustrations
Front of the device and transducers
Back of the device
Screens / display
Explanation of symbols
Page
1
Indications / Contraindications
1.1 Indications - electrotherapy
1.2 Contraindications - electrotherapy
1.3 Indications - ultrasound therapy
1.4 Contraindications - ultrasound therapy
1
3
4
5
2
Side effects 6
3
Application information
3.1 General
3.2 Electrotherapy
3.3 Ultrasound
7
8
9
4
Warnings
4.1 General
4.2 Electrotherapy
10
11
5
PhySys – in brief 12
6
Intended use 13
7
Device set-up 14
8
Default settings
8.1 General
8.2 Therapy
15
16
18
9
Operation instructions
9.1 Electrotherapy
9.2 Ultrasound therapy
9.3 Combined therapy
9.4 Vacuum unit (VacoP)
9.5 Electrotherapy in combination with a vacuum unit (VacoP)
9.6 Informationon the operation of VacoP
9.7 Indication menu
9.8 Saving programs
9.9 Favourites / Memorylist: Retrieve programs, edit list
9.10 Sequence programs
9.11 Program free sequence program
19
22
24
25
27
29
30
32
33
34
35

Content
10
Technical information
10.1 General
10.2 Stimulation current
10.3 Ultrasound
10.4 Vacuum
36
37
38
39
11
Cleaning / Disinfection 40
12
Electrodes
Information on the use of different types of electrodes
42
13
CE mark / manufacturer 43
14
Scope of delivery and accessories 44
15
Device combination 47
16
Safety and maintenance 48
17
Functional test 49
18
Legal notice 50
19
Error messages / troubleshooting / disposal 52
20
Manufacturer's EMC declaration 53
Valid for the device PhySys, SD edition.
These instructions for use are an integral part of the device. They must be
stored with the device and kept accessible at all times for anyone authorised to
operate this device.
Last updated: July 2017

Indications / Contraindications
1.1 Indications - Electrotherapy
1
Page 1
Circulation-promoting
therapy
•Functional circulatory disorders
•Angiopathy in diabetes mellitus
•Angioneuropathy (Raynaud's disease)
•Acrocyanosis
•Venous vascular diseases
•Chronic venous insufficiency
•Reflex sympathetic dystrophy
•Sudeck's syndrome (stage II)
•Lymphoedema
•Treatment of the facial nerve (as a pre-treatment)
•Chronically contracted muscles
•Peripheral joint disease (chronic)
•Radicular syndrome in the setting of spinal diseases (subacute and chronic)
•Ligament ruptures
•Tenosynovitis
•Bursitis
Analgesic therapy
•Strains, contusions, sprains to muscles, tendons, joints and bones
•Extensive myalgia
•Polyarthralgia
•Joint diseases, inflammatory
•Chronic polyarthritis (rheumatoid arthritis),
treatment during the low inflammation interval
•Diffuse pain in periarthropathy, osteoarthritis, ankylosing spondylitis
•Tendinitis, tenosynovitis
•Local and pseudoradicular spinal diseases
•Radicular lesion
•Disc surgery
•Inflammatory spinal diseases, chronic
•Chronic pain conditions, pain disorder
•Pelvic pain (adnexitis)
•Pelvic pain (prostatitis)
•Neuralgia
•Neuritis
•Polyneuropathy
•Radicular syndrome
•Nerve compression syndrome
•Allodynia
•Causalgia (complex regional pain syndrome)
Trophicity-promoting
therapy
•Venous ulcers
•Neurotrophic ulcers
•Decubital ulcers
•Delayed wound healing
•Osteoporosis
•Delayed bone healing
•Ligament ruptures
Muscle-toning therapy
•Muscle weakness
•Poor innervation of the skeletalmuscles
•Absent muscle sensation

Indications / Contraindications
1.1 Indications - Electrotherapy
1
Page 2
Muscle-relaxing therapy
•Muscular overload
•Painful muscle tension
•Myofascial pain syndrome
•Tendon and muscle ruptures
•Contractures
Experiences from clinical
practice have also
shown that there may be
a positive effect when
treating the following
conditions:
•Periarthropathy and insertional tendinopathy (acute, subacute)
•Periarthropathy and insertional tendinopathy (chronic)
•Peripheral joint disease (acute, subacute)
•Posttraumatic conditions (haematoma, oedema)
•Excessive sweating of the hands and feet
(Hyperhidrosis palmarum et plantarum)
•Acquired postural disorders of the spine:
posttraumatic, postinflammatory, degenerative
•Postural disorders of the spine in childhood and adolescence
•Spinal fractures, spondylodesis
•Joint surgeries, arthroscopy, arthrotomy
•Congenital malformations and deformities or maladjustment of the locomotor organs for
treatment in childhood
•Stool incontinence
•Urinary incontinence
•Impaired gut motility
•Chronic constipation
•Secondary lymphoedema and lymphostasis
•Chronic pelvic pain
•Polyneuropathy
•Spinal muscular atrophy
•Peripheral paresis, plexus paresis
•Non-local, generalised spinal diseases
•Spasticity
•Spastic paralysis
•Slack paralysis
•Psoriasis

Indications / Contraindications
1.2 Contraindications - Electrotherapy
1
Page 3
General
Contraindications
•Unclear pain symptoms
•Acute inflammation (local, systemic)
•(Suspected) cardiovascular diseases
•(Suspected) epilepsy
•Peripheral arterial occlusive disease, stage IIb or higher according to Fontaine
•Purulent processes
•Fever
•Generalised infections
•Benign and malignant tumours
•Thrombophlebitis
•Phlebothrombosis with the risk of emboli
•Cardiac pacemaker and other implanted electronic devices
•Transcardial current flow
•Metal implants in the circulation territory when galvanic or unipolar currents are used with
pulse widths of more than 1 ms
•Psychoses
•In cases of limited skin sensitivity
•Use on or near open wounds or over fractures
The following should
also be borne in mind in
the case of TENS therapy
•Pain that can be causally relieved
•Primarily psychogenic pain (TENS therapy is ineffective)
•Central pain syndrome, such as thalamic pain syndrome
Contraindications which
should also beborne in
mind
Muscle treatment with surged group pulses (surge currents) for:
•loss of consciousness, reduced state of consciousness
•Reflex inhibition (e.g. in the case of fractures)
•Muscle inflammation
•Facial muscles
•If the electric stimulation therapy triggers persistent pain
•Infants, young children
•If spasticity increases
•Pregnancy
Special caution:
•In the case of a bleeding tendency following acute trauma or fracture
•Following surgical procedures if muscle contraction can disrupt the healing process
Precautions for certain
current forms
Diadynamic current, Träbert current
•Careful electrode technique is necessary to avoid possible skin injury due to high galvanic
component of the diadynamic currents.
•Careful dosing in the case of sensitivity disorders
Electroacupuncture
•No needle acupuncture in the case of coagulation disorders

Indications / Contraindications
1.3 Indications - Ultrasound therapy
1
Page 4
Indications from
orthopaedics, surgery,
traumatology
rheumatology
•Vertebrogenic pain syndrome, e.g. cervical syndrome
•Ankylosing spondylitis (only during the inflammation-free interval)
•Joint diseases
•Rheumatoid arthritis (if heat treatment is indicated)
•Osteoarthritis
•Periarthropathy
•Epicondylopathy
•Chronic tendinitis, periostitis, heel spur
•Achillodynia
•Scars, contractures, Dupuytren's contracture
•Posttraumatic discomfort
•Fractures (especially with delayed callus formation)
Other indications
•Bronchial asthma
•Rhinopathy
•Persistent discomfort of the cervical spine following whiplash with repetitive blockages
•Headaches
•Earaches
•Postherpetic neuralgia
•Functional disorders of the stomach and duodenum
•Chronic pelvic pain
•Functional discomfort of the lesser pelvis

Indications / Contraindications
1.4 Contraindications - Ultrasound therapy
1
Page 5
General
contraindications
•Unclear pain symptoms
•Diseases for which heat should not be used, such as acute inflammatory diseases
•Diseases in which mechanical influences are contraindicated, such as phlebothrombosis
•Limited blood flow
•Suspected cardiovascular diseases
•Haemorrhagic diathesis
•Do not treat cervically higher than C3
•Ultrasound treatment of parenchymatous or heat-sensitive organs
(testes, eyes, gravid uterus, liver, kidney, etc.)
•Anaesthetised areas of skin
•Abnormal temperature perception
•Following treatment with ionising radiation
•Epiphyseal plates
•Tumours
•Electronic pacemakers
•Use on or near open wounds
•Limited reflexes or pain sensitivity
•Use on the abdominal, pelvic or lumbar regions during pregnancy or suspected pregnancy
Metal implants and endoprostheses
Nowadays there are no more concerns against the use of dynamic, low-dose ultrasound.

Side effects
2
Page 6
Side effects of
electrotherapy
No side effects are known if used correctly.
Side effects of ultrasound
therapy
No side effects are known if used correctly.

Application information
3.1 General
3
Page 7
Prior to using the device on a patient, the user should become familiar with the instructions for
use and individual treatment methods to be used as well as the indications / contraindications,
warnings and application information. Additional sources of information about the ultrasound
therapy should be followed.
These instructions for use must always be stored with the device and kept accessible at all
times for anyone authorised to operate this device.
Caution!
To avoid the risk of electric shock, the plug must be disconnected from the power supply before
performing any cleaning or maintenance activities.
Caution!
Before use, ensure that the device is powered via a properly grounded mains socket (electrical
installation according to DIN VDE 0100 Part 710). The device must only be operated with the
supplied power cable. The power cable must be protected against mechanical stress.
Caution!
Magnetic and electrical fields can affect the function of the device. For this reason, do not
operate the device in the vicinity of devices which generate strong electromagnetic fields (X-ray
or diathermy equipment, MRI machines). Please keep a safe distance of several meters.
Caution!
The device is not suitable for use in areas with an explosive, flammable or combustive
environment.
Caution!
During use, the device is to be located in a position allowing direct access to the device´s
central mains supply so that it can be disconnected from the mains at any time.
Caution!
Inspect the device before use. If there is any damage, it must not be used.
Caution!
Only accessories provided by Zimmer MedizinSysteme GmbH may be used.
Caution!
The device may cause malfunctions or may interfere with the operation of equipment in the
vicinity. It may be necessary to take appropriate remedial action, such as realignment, re-
arrangement of the device or install shielding.
Caution!
During the service life of the device, no changes may be made to the device or medical
system.
Caution!
The complete medical system is suitable for use in the vicinity of the patient.
Caution!
To safely disconnect the device from the power supply, pull the mains plug out of the housing
socket or outlet.

Application information
3.2 Electrotherapy
3
Page 8
Electrode positioning and the selection of treatment parameters should always be coordinated
to the treatment specifications.
For currents for which there is a risk of chemical burns (for example, galvanic current,
diadynamic currents, currents with a galvanic component), the recommended maximum
current density is 2 mA eff/cm² electrode surface.
If the current density exceeds 2 mA eff/cm², increased attention on the part of the user is
necessary.
When using different electrodes, be aware that in the case of a smaller electrode surface, a
higher current density may be reached.
Caution!
Stimulation current treatment should not be performed on the head or directly on the eye.
Caution!
In combined operation, the ultrasound head can be used as a dynamic electrode in connection
with a stationary electrode which is connected via the electrode cable. In such a case, the
ultrasound and electrode channel constitute an applied part. Please be advised that in this
operation, therapeutic currents flow through the ultrasound transducer.

Application information
3.3 Ultrasound
3
Page 9
Handle transducer gently; rough handling can alter its characteristics. Do not allow sharp or
pointed objects to come into contact with the ultrasound transducer since the aluminium head
can be easily scratched.
The use of coupling agents other than the special Sono plus ultrasound gel can damage the
ultrasound transducer.
Disinfect ultrasound transducer after use with conventional equipment disinfectants.
Inspect the ultrasound transducer for damage before each use. If there is anydamage, the
ultrasound transducer must not be used.
Caution!
During combined operation, the ultrasound transducer can be used as a dynamic electrode in
connection with a stationary electrode which is connected via the electrode cable. In such a
case, the ultrasound and electrode channel constitute an applied part. Please ensure that in
this operation, therapeutic currents flowthrough the ultrasound transducer.
Caution!
If the ultrasound transducer is regularly used in a water bath, measures which protect the user
must be taken. All user body parts submerged in water must be protected through appropriate
measures. Appropriate protective measures include what is known as “aerated clothing.”
These can include, for example: neoprene gloves or latex over cotton gloves.

Warnings
4.1 General
4
Page 10
This device is intended to be used exclusively by medical professionals.
It must always be ensured that two patients are never simultaneously connected to the device
during a treatment session!
The patient must not be left unattended during therapy.
Any treatment instructions regarding treatment location, duration and intensity require medical
knowledge and should be given by authorised physicians, therapists and medical
paraprofessionals. These instructions must be followed.
Use in wet areas is not permitted and may in case of non-compliance lead to considerable
damage and endanger both the patient and the user.
Dispose of the packaging material properly. Make sure that it is not accessible to children.
The use of the device out of the settings or applications specified in the instructions for use may
lead to hazard by the uncontrolled emission of ultrasound energy.
On patients with implants or an implanted electronic device do not conduct treatment before the
risk has been assessed and found negligible.
Patients may not be connected to a high-frequency surgical device at the same time. This can
lead to burns.

Warnings
4.2 Electrotherapy
4
Page 11
Electrotherapy
Placing electrodes near the chest can increase the risk of ventricular fibrillation.
When performing iontophoresis, the drug used may have an analgesic effect and pain
sensitivity is reduced as a result.
Stimulation current can have a stimulating effect on insulin release. This may result in
hypoglycaemia in diabetic patients.
The electrical stimulation or materials used can cause skin irritation or hypersensitivity in
sensitive patients. This can be reduced through the use of an alternative electrode material or
by changing the position of the electrodes.
Stimulation may not be used:
•over the carotid sinus nerve
•over the neck and mouth
•transthoracically
•transcerebrally
•over swollen, infected, inflamed areas
•over or near cancerous lesions
Vacuum
In patients who tend to develop haematomas, treatment should only be performed after the risk
has been assessed and found negligible.
Note:
The above warnings apply to electrotherapy in combination with the vacuum unit.
When the intensity controller is turned up high, currents above 10 mA eff may flow or
there may be voltages over 10 V at the output sockets.

PhySys – in brief
5
Page 12
What is PhySys?
An ultramodern, innovative combination device for electro- and ultrasound therapy with the
option of additionally using a vacuum unit.
What does PhySys do?
The emission of monophasic, biphasic and medium-frequency currents for nerve stimulation
and muscle therapy in single-channel and dual-channel operation as well as the emission of
therapeutic ultrasound.
What are the benefits of
PhySys?
A large colour display showing all therapy-related parameters, modern touch operation as well
as individual program start settings and a clear, simple menu navigation ensure maximum
convenience for the user.
The combination of electro- and ultrasound therapy in one device makes the proven combined
therapy possible.
The integration and the use of the vacuum unit ensure convenientelectrode application and
also create a pleasant massage effect for the patient.
In combination with the column, convenient storage of the accessories is possible.
PhySys innovations
In the case of SonoSwing, the innovation in the field of ultrasound therapy:
•an ultrasound transducer with 2 frequencies
•freely selectable depth of penetration through the adjustability of the frequency
components by percentage
Separately controlled mechanical and thermal effects enable the type of effect to be
individually selected.
The user can freely select whether a thermal effect or a mechanical effect is desired.
Note:
The application of the device is reserved for medical professionals (such as physicians,
therapists and health paraprofessionals).

Intended use
6
Page 13
Intended use
PhySys is a combination device for therapeutic ultrasound and electrotherapy with the option
of a vacuum unit for electrode application and supportive massage.