Zimmer PhySys User manual

Instructions for Use
PhySys
EN

Illustrations
Front of the device / Ultrasound heads
Fig. 1
Selection and operating
elements
1 Mains switch
2 Intensity regulator channel I
3 Display
4 Intensity regulator channel II
Fig. 2
Ultrasound heads
17 Ultrasound head, large, 5 cm²
18 Ultrasound head, small, 1 cm²
2
4
3
1
17
18

Illustrations
Rear of the device
Fig. 3
Ports
5 Port for ultrasound head 0.8/2.4 MHz
6 Port for patient cable channel II
7 Socket for power cable
8 Port for patient cable channel I
9 Port for ultrasound head 0.8/2.4 MHz
10 Identification plate
11 USB connection
5
6
7
8
9
11
10

Illustrations
Rear of the device / Screens and displays
Fig. 4
Display views
12 Status line
13 Buttons on the screen
14 Buttons in the navigation menu
15 Buttons in the status line
Fig. 5
Navigation menu /
Status bar
Description of the
functions
(A) Back
Switches one page back or to the start-up screen
(B) Therapy
Shows the therapy mode
(C) Memory
Switches to device memory
(D) Programmes
Switches the screen to therapy selection
(E) Favourites
Switches to favourites
(F) Protocols
Switches to protocols
(G) Save
Switch to device memory to save a program
14
13
12
B
A
C
D
E
F
G
15

Explanation of symbols
In the instructions for use this symbol indicates “Caution”.
Attention
!
In the instructions for use this symbol indicates "
Attention
" in order to avoid possible damage
of the device.
Applied part type BF
Electronic instructions for use available depending on the version
Follow instructions for use
Serial number
Catalogue number
Manufacturer
Date of manufacture
This symbol identifies hazardous points on the device.
Interval operation30 minutes on, 10 minutes off
USB connection port
Rating of the accessible fuses
Port for ultrasound head
Port for patient cable
Disposal of electrical and electronic devices as well as used disposable and
rechargeable batteries. The products marked with the symbol opposite should not be
discarded in household waste.

Contents
Illustrations
Front of the device and ultrasound heads
Rear of the device / Ultrasound headsScreens / display
Explanation of symbols
Page
1
Areas of application / Contraindications
1.1 Areas of application – Electrotherapy
1.2 Contraindications – Electrotherapy
1.3 Areas of application – 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 / Intended purpose 13
7
Device set-up 14
8
Configuration
8.1 General
8.2 Electrotherapy / ultrasound
8.3 Maintenance
15
16
17
9
Operation instructions
9.1 Electrotherapy
9.2 Ultrasound therapy
9.3 Combined therapy
9.4 Electrotherapy with VacoP/ VacoPsolo
9.5 Information on the operation of VacoP
9.6 Protocols
9.7 Saving programs
9.8 Favourites/memory list: Access program, edit list
9.9 Sequence programs
9.10 Overview of paralysis diagnostics and therapy
18
21
24
25
27
28
29
30
31
32

Contents
10
Technical information
10.1 General
10.2 Stimulation current
10.3 Ultrasound
10.4 VacoP
33
34
35
36
11
Cleaning / Disinfection 37
12
Electrodes
Information on the use of different types of electrodes
39
13
CE mark / Manufacturer 40
14
Scope of delivery and accessories 41
15
Device combination 44
16
Safety and maintenance 45
17
Functional test 46
18
Legal notice 46
19
Error messages / Troubleshooting / Disposal 47
20
Manufacturer's EMC declaration 48
Valid for the device PhySys.
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: 05/2019

Areas of application / Contraindications
1.1 Areas of application – Electrotherapy
1
Page 1
Electrotherapy is used to promote circulation, to provide analgesia, to improve trophicity, to
relieve muscle tension and to improve muscle tone.
Other areas of application are musculoskeletal diseases, rehabilitation and wound healing.
In addition, electrotherapy can be used for paralysis diagnostics.
Experiences from clinical practice have shown that there may be a positive effect when
treating the following problems:
•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
•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)
•Venous ulcers
•Neurotrophic ulcers
•Decubital ulcers
•Delayed wound healing
•Osteoporosis
•Delayed bone healing
•Ligament ruptures

Areas of application / Contraindications
1.1 Areas of application – Electrotherapy
1
Page 2
•Muscle weakness
•Poor innervation of the skeletal muscles
•Absent muscle sensation
•Muscular overload
•Painful muscle tension
•Myofascial pain syndrome
•Tendon and muscle ruptures
•Contractures
•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:
posttrraumatic, 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
•Flaccid paralysis
•
Psoriasis

Areas of application / 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 be borne 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

Areas of application / Contraindications
1.3 Areas of application – Ultrasound therapy
1
Page 4
Ultrasound therapy is used in orthopaedics, surgery, traumatology and rheumatology.
Experiences from clinical practice have shown that there may be a positive effect when
treating the following problems:
•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)
•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

Areas of application / 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 cervical vertebrae 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
If used as intended, no side effects are known.
Side effects of ultrasound
therapy
If used as intended, no side effects are known.

Application information
3.1 General
3
Page 7
Attention
!
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 areas of
application/contraindications, warnings and application information.
Attention
!
Electronic instructions for use are available in PhySys, depending on the version.
If the electronic instructions for use are available in the device, there are no printed instructions
for use enclosed with the device. They can be accessed via the Zimmer website at
www.zimmer.de/eIFU.
The printed instructions for use can be requested from the manufacturer and ordered within 7
days by mail.
Attention
!
The instructions for use must always be stored with the device and kept accessible at all times
for anyone authorised to operate this device.
Attention
!
To avoid the risk of electric shock, the plug must be disconnected from the power supply before
performing any cleaning or maintenance activities.
Attention
!
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.
Attention
!
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.
Attention
!
The device is not suitable for use in areas with an explosive, flammable or combustive
environment.
Attention
!
The device must be set up in such a way as to allow immediate access to the device´s central
mains supply so that it can be disconnected from the mains at any time. Examine the device
before use. If there is any damage, it must not be used.
Attention
!
Only accessories provided by Zimmer MedizinSysteme GmbH must be used.
Attention
!
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.
Attention
!
During the service life of the device, no changes may be made to the device or medical
system.
Attention
!
The complete medical device is suitable for use in the vicinity of the patient.
Attention
!
To safely disconnect the device from the power supply, pull the mains plug out of the housing
socket or outlet.
Attention
!
Do not place the device in the vicinity of heat sources (heater, hot medicinal mud products,
sauna, etc.) and leave a distance of at least 50 cm between the device and a wall (to enable
the supply of treatment products and cold air).

Application information
3.2 Electrotherapy
3
Page 8
Attention
!
Electrode positioning and the selection of treatment parameters should always be coordinated
to the treatment specifications.
Attention
!
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 distributed over the electrode surface.
Attention
!
If the current density exceeds 2 mA eff/cm², increased attention on the part of the user is
necessary.
Attention
!
When using different electrodes, be aware that in the case of a smaller electrode surface, a
higher current density may be reached.
Attention
!
Stimulation current treatment should not be performed:
•Over or through the head
•Directly on the eye
•In the mouth area
•On the front of the neck (in particular the carotid sinus)
•
In the area of the chest or upper back if the current is conducted through the heart.
Attention
!
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 ensure that in this
operation, therapeutic currents flow through the ultrasound head.

Application information
3.3 Ultrasound
3
Page 9
Attention
!
Handle the ultrasound head gently; rough handling can alter its characteristics. Do not allow
sharp or pointed objects to come into contact with the ultrasound head since the aluminium
head can be easily scratched.
Attention
!
The use of coupling agents other than the special Sono plus ultrasound gel can damage the
ultrasound head.
Attention
!
Disinfect the ultrasound head after use with conventional equipment disinfectants.
Attention
!
Inspect the ultrasound head for damage before each use. If there is any damage, the
ultrasound head must not be used.
Attention
!
If the ultrasound head 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.
The person to be treated must be able to clearly communicate pain; small children and babies
in the growth phase are excluded.
Any treatment instructions regarding treatment location, duration and intensity require medical
knowledge and should only 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.
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.
Do not conduct treatment on patients with implants or an implanted electronic device before the
risk has been assessed and found negligible.
Simultaneous connection of the patient to the ME device for high-frequency surgery can result
in burns under the electrode surfaces of the stimulation current device and damage to the
stimulation current device.
No maintenance work should be performed during electrotherapy.
Operation in the immediate vicinity (e.g. 1 m) of an ME device for short-wave or microwave
therapy can cause fluctuations in the starting values of the stimulation current device.

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.
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 VacoS.
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 are the features 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 convenient electrode application and
also create a pleasant massage effect for the patient.
In combination with the SysCart, convenient storage of the accessories is possible.
PhySys innovations
In the case of SonoSwing, the innovation in the field of ultrasound therapy:
•an ultrasound head 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 micro massage is desired.
Note:
The application of the device is reserved for medical professionals (such as physicians,
therapists and health paraprofessionals).