Zimmer Micro 5 User manual

Micro 5
EN
Instructions for use

Figure
Front of the device
Fig. overall view
Radiator head cable
Radiator head
connection
Adjustable radiator head
Adjustment knob for
radiation field
Housing with
vents
Cruciform base with
device rollers

Figure
Rear of the device
Fig. front plate
Power display
Frequency display
reatment clock
Operating display
Mains connection display
Display, unpulsed
Display, pulsed
Start/stop button
Operating mode button
(unpulsed/pulsed)
ime setting
Intensity controller
Test lamp

Figure
Screens and display
Fig. rear
Power inlet with
mains connection switch and
fuses
Connection for
radiator head cable
Housing with
vents

Explanation of symbols
In the instructions for use this symbol indicates “Danger”.
Caution !
In the instructions for use this symbol indicates “Caution” with regard to possible
damage of the device.
Applied part B
his symbol points out hazardous areas on the device.
his symbol warns of high voltage.
his symbol warns of non-ionising radiation.
Prohibited for people with cardiac pacemakers.
Follow instructions for use.
Instructions for use
Serial number
Item number
Manufacturer
Date of manufacture

Content
Figures
Front of the device
Rear of the device
Screens / display
Accessories
Explanation of symbols
Page
1.
Indications / Contraindications
Fehler!
extmar
ke nicht
definiert
1.1.1.
2.
Side effects
3
1.1.2.
3.
Application information
4
1.1.1.
4.
Warnings
5
1.1.1.
5.
Micro 5 - in brief
6
1.1.2.
6.
Device set-up
7
1.1.1.
7.
Default settings
8
1.1.2.
8.
Operation instructions
9
9.
echnical information
13
10.
Cleaning / Disinfection
14
1.1.3.

Content
11.
CE mark
15
1.1.4.
12.
Scope of delivery and accessories
16
1.1.5.
13.
Device combinations
17
14.
Safety and maintenance
18
1.1.6.
15.
Functional test
19
16.
Safety check / metrological check
20
1.1.7.
17.
Fault messages / troubleshooting / disposal
21
18.
EMC declaration
22
1.1.8.
Valid for the device Micro 5.
hese instructions for use are an integral part of the device. hey must be stored with
the device and kept accessible at all times for anyone authorised to operate this device.
he instructions for use are valid as of June 2019.

Indications / Contraindications
1
Page 2
Indi
cations
Further treatment recommendations
Pain relief during
 Carpal unnel Syndrome
 Knee Osteoarthritis
 Shoulder pain
Pain relief at
 Chronic back pain and neck pain
 Damage to the shoulder joint
Contraindications

Acute and subacute thrombophlebitis
 Peripheral arterial circulation disorders
 Lack of sensitivity to temperature (e.g. in cases of syringomyelia,
polyneuropathy)
 Pregnancy and menstruation
 Acute adnexitis, parametritis, endometritis
 Acute frozen shoulder
 Acute traumatic lesions and haematomas
 Sudeck's syndrome stage I
 Large accumulations of fluid in tissues (e.g. pleural effusion, ascites)
 Febrile infectious conditions tuberculosis, acute neuritis, acute
prostatitis
 umours, metastases
 Individuals who are unconscious or not fully capable of responding,
infants
 Wet clothing and wet dressings
 Radiation must not be applied directly to metallic foreign bodies such
as endoprostheses, metal plates and metal discs. hese objects must
therefore remain outside the radiation field.
Cardiac pacemakers are an absolute contraindication!
Caution is necessary when treating patients with impaired heat
sensitivity.
Microwave treatment must not be administered to individuals who have
previously taken circulation-boosting products (e.g. Finalgon
®
, ABC-
Pflaster
®
patches).
Please see the relevant literature for professionals for further indications and
contraindications.

Side effects
2
Page 3
Side effects of
microwave treatment
No side effects are known if used correctly.

Application information
3
Page 4
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 treatment should also be followed.
Caution !
Before use, ensure that the device is powered via a properly grounded mains power
outlet (electrical installation according to DIN VDE 0100 Part 710). he device must
only be operated with the supplied power cable. he power cable must be protected
against mechanical stress.
Caution !
Micro 5 is not suitable for use in areas with an explosive, flammable or combustive
atmosphere.
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 !
o avoid the risk of electric shock, the plug must be disconnected fr
om the power
supply before performing any cleaning or maintenance activities.
Caution !
Inspect the device before use. If there is any damage, it must not be used.
Caution !
Only accessories provided by Zimmer MedizinSysteme GmbH must be used.
Caution !
he device should be switched off when placing the adjustable radiator head on the
treatment area.
Caution !
he patient must wear suitable microwave protection glasses if necessary.

Warnings
4
Page 5
Please ensure that:

the operator is not in the action range of the radiator head during treatment. All people
not undergoing treatment should be more than 1.5 m away from the radiator head being
used.
 metallic objects such as jewellery, items of clothing with metallic threads, that are in the
treatment area must be removed.
 the radiator is not directed at metallic surfaces (such as couch, washbasin, device
housing etc.) while it is in operation.
 the intensity of the device is set to zero while the radiator head is being positioned.
 you never direct the radiator head at the patient’s head area or testes, or treat these
body parts. Even when radiation is being applied to other body parts, the radiator head
must be positioned so that the head area and testes are not in the area exposed to
radiation.
 patient body parts which contain metallic implants (such as bone pins, artificial joints for
example) must not be treated.
 patients with impaired heat sensitivity (sensitivity disorder) in the part of the body for
which treatment is intended should as a rule not undergo microwave treatment.
 patients with implanted electronic devices (cardiac pacemaker, ICD, etc.) and/or
electrodes should not be treated. hese people should also not enter rooms in which
diathermy devices (such as Micro 5) are used.
 hearing aids and other electronic devices worn by the patient are removed before
treatment. he devices could be impeded in their action or suffer lasting damage.
 the radiator head and its cable are handled with the necessary care. Heavy blows and
knocks can alter its targeting properties.
 the device cannot be opened, as this could make life-threatening high voltage
accessible.
 the device is not operated if the radiator head or its cable are damaged.
 the device is only operated when the radiator head cable’s plug connections are closed
and secured by means of spring clips.
 the heat generated in the device can always escape; the air vents must be kept clear.
 the device must not be used in “wet rooms” (hydrotherapy rooms, bathrooms).
 if liquid or foreign objects penetrate the housing, the plug must be removed from the
power outlet immediately and the device must be checked by an authorised customer
service unit before you use it again.
 the radiation emitted by the radiator head does not directly reach electronic devices in
the immediate vicinity or Micro 5 itself. he devices can be impeded in their action or
suffer lasting damage.
 you leave a safety distance of 5 m from medical devices being operated at the same
time. If any problems occur, stop treatment. We would be happy to inform you about any
shielding measures that may be necessary.

he device must not be used in the presence of flammable anaesthetics.

Micro 5
-
in brief
5
Page 6
What is Micro 5 used for?
(Intended use)
Micro 5 is a microwave treatment device for the contactless application of
microwaves to heat tissues in people suffering from musculoskeletal
conditions.
he application of the device is reserved for medical professionals (such as
physicians and health paraprofessionals).
How does Micro 5 work?
Microwave treatment involves converting electrical energy into thermal
energy directly in the tissues. External heat application via the skin, using
heat packs for example, does not allow such deep heating as the blood
circulation would remove the heat before it reached its destination.
What are the benefits of Micro 5?
Micro 5 is easy to use, and its adjustable radiator head allows it to be used
in various treatment situations.
What are the other benefits of Micro 5?
wo selectable pulse frequencies mean that the heat pulses can be clearly
felt. he pulse method allows higher intensities to be applied at a constant
average power level, enabling heat to penetrate deeper.

Device set
-
up
6
Page 7
Fitting the radiator head arm
Push the radiator head arm into the corresponding bracket on the hood of the
device.
Fitting the radiator head cable
Place the ball
joint of the radiator head cable into the upper bracket of the radiator
head arm and attach it by means of the fixing screw. Use the connector to attach
the free end underneath the radiator head arm bracket on the back of the device.
Remove the spring clip from the connector before inserting the cable. hen push
the clip to secure the cable.
Fitting the adjustable radiator
head
here is a spring clip on the plug connection to the radiator head which secures
the radiator head in place. he radiator head can only be fitted or removed if this
clip is taken off. his allows the ring underneath the clip to be pulled back so that
the radiator head can be inserted or removed. hen replace the clip.
Connecting the device to a power
supply
Micro 5 may only be o
perated on a secure power supply for medical premises in
application group 1 in accordance with VDE 0107. Only use the power cable
supplied. Check for correct mains voltage before connecting the device to the
power supply.
he device is not suitable for use in areas with an explosive, flammable or
combustive atmosphere.
Micro 5 must not be coupled or connected to other devices.

Default settings
7
Page 8
Brief operation instructions
Switch on the device at the mains connection
switch. he mains connection
display lights up, and after self-testing an acoustic signal is produced and then
the software version number is displayed. Micro 5 is ready for use.
Direct the radiator head at the part of the body to be treated, or place it
directly on the part. Make sure that the radiator head setting is correct for the
part of the body to be treated.
Follow the instructions for positioning the radiator head when doing this.
Press the start/stop button.
Preselect “unpulsed” or “pulsed” treatment form and pulse frequency if
applicable.
Preselect treatment time.
Start treatment by increasing the intensity control setting.
Comply with the dosage guidelines when doing this.
An acoustic signal is produced at the end of the preset treatment time.
Intensity returns to zero.
Comply with the warnings in these instructions for use!

Operation instructions
8
Page 9
Note:
The following recommendations are only guidelines and must of course be adapted
to the patient's individual situation.
o switch on the device, place the mains connection switch (rear of the device) in
position I. he device performs a self-test after it has been switched on. All display
elements are controlled. After completion of a successful self-test, an acoustic signal
is produced and the software version number is shown. he device is now ready for
use.
Switch the device off at the mains connection switch if there are to be prolonged
gaps in treatment, and after use.
he mains
connection display glows steadily when the device is switched on.
he operating display flashes for 5 seconds after the intensity controller has been
activated while the device performs self-calibration. he operating display then glows
steadily and further dosage control can be carried out with the intensity controller.
his display glows steadily when unpulsed operating mode is selected.
he unpulsed operating mode is active after the device has been switched on.
his display glows steadily wh
en pulsed operating mode is selected.
he power display shows the current microwave power output in watts.
Low-power operating mode is indicated by an “L” on the left.
If a fault occurs in the device, an “F” appears in the power display followed by a fault
number (see chapter 13).
he frequency display shows the pulse frequency selected in the case of pulse
operating mode.
he treatment clock shows the preset treatment time, and the time remaining to the
end of treatment while treatment is being administered. An acoustic signal is
produced at the end of the treatment time and the power output is reset.
A treatment time of 10 minutes is preselected when the device is switched on.
he start/stop button interrupts a current treatment before th
e end of the treatment
time. Pressing the button again restores the treatment time to the initial value.
After the device has been switched on, the buttons and intensity controller are
released only after the start/stop button has been activated.
Pressing the
operating mode
button repeatedly causes the device to cycle between the
following operating modes: unpulsed, pulsed 0.5 Hz low power, pulsed 1 Hz low power,
pulsed 0.5 Hz and pulsed 1 Hz. he low power operating modes are indicated by an “L” in the
power display.
he other buttons and the intensity controller are released only after the start/stop button
has been activated after the device is switched on.
he unpulsed operating mode is active after the device has been switched on.

Operation instructions
8
Page 10
he
incre
ase time
button increases the treatment time set by one minute each time that it is
pressed. he longest possible treatment time that can be selected is 30 minutes.
he
reduce time
button reduces the treatment time set in one
-
minute increments. No
treatment is possible if the treatment time is set to zero.
he
intensity controller
allows the device’s microwave power to be set in increments of 2 or
5 watts depending on the operating mode selected. urn the dial clockwise to increase the
power, and anti-clockwise to reduce it.
he maximum power levels are: 250 watts in unpulsed mode, 125 watts in pulsed modes, and
50 watts in pulsed low power modes.
After the intensity controller is activated for the first time and the device is ready for use
(mains connection light on, operating display off), the device first performs self-calibration and
the operating display flashes. After 5 seconds the operating display starts to glow steadily.
Now the microwave output can be set and treatment can begin.
Operati
ng modes
Micro 5 offers the following operating modes:
unpulsed: max. 250 W
pulsed 0.5 Hz low power: max. 50 W pulse-pause ratio 1:2
pulsed 1 Hz low power: max. 50 W pulse-pause ratio 1:2
pulsed 0.5 Hz: max. 125 W pulse-pause ratio 1:1
pulsed 1 Hz: max. 125 W pulse-pause ratio 1:1
Adjustable radiator
head
urning the adjustment knobs on the adjustable radiator head allows the operator to adjust
the physical size of the radiation field to be adjusted to the requirements of the part of the
body being treated.
he size of the field should correspond to the size of the part of the body being treated.
Positioning of the
radiator head
he radiator head must be at least 10 cm away from the part of the patient’s body being
treated, and must not touch the skin.
Caution!
When adjusting the radiation field and positioning the radiator head, ensure that no
other body parts (e.g. eyes, testes) can be accidentally exposed to radiation because they are
in the radiation field. If necessary, change the position of the radiator head or the patient’s
posture.
Caution!
Make sure that there is no power output and so no accidental emission of radiation
to the patient or operator while positioning the radiator head.
Caution!
Particular caution is necessary if the radiator head is very close to or on the patient’s
body, because this limits heat escape.
Caution!
No metallic objects (jewellery, belt buckles, wallet/purse, clothing with metal
fibres, implants, etc.) may be present in the radiation field!

Operation instructions
8
Page 11
Comply with the warnings in these instructions for use when positioning the
radiator head!
Adjusting the radiator head
he radiation properties of the radiator head can be adjusted to the requirements of
treatment. Adjust the knobs to produce the following radiation fields.
Large field setting
Circular field setting
Half field left
Half field right
Dosage
Dosage
Increase the power only until the patient feels a sensation of heat
that is still pleasant.
We do not recommend increasing the dose even if the sensation of heat declines
during treatment.
Ask the patient how he/she is feeling during treatment. If the patient describes the heat
as unpleasant or painful, reduce the intensity or interrupt treatment.

Operation instructions
8
Page 12
he following rule applies to dosage: the more acute the condition, the lower the dose.
Patients with chronic conditions can receive higher doses of radiation. reatment times
should be shorter for acute conditions and longer for chronic conditions, in general
between 10 and 15 minutes. reatment can be administered daily, with 6 to 12
treatments in a course.
Caution seems appropriate with regard to dosage for patients with impaired sensitivity
and in cases where radiation is to be administered to organs with low vascularisation,
such as eyes and testes (heat congestion). Protection glasses (special accessories)
must be used to protect the eyes when administering radiation to the head area.
Patients with cardiac pacemakers must not undergo microwave treatment.
he range of indications for which Micro 5 can be used is broader if the pulse
operating mode option is selected. he low level of energy conversion means that
there are no heat effects in this form of administration. his means that many
additional indications can be treated, especially those relating to inflammatory and
traumatic processes.
Comply with the warnings in these instructions for use!
Caution is necessary when treating patients with impaired heat sensitivit
y!
Patients with cardiac pacemakers must not undergo microwave treatment.

echnical information
9
Page 13
Device type
Microwave treatment device
Operating frequency
2450MHz ± 25MHz
High
-
frequency power
at 60 
unpulsed: max. 250W
pulsed: max. 125W pulse-pause ratio 1:1
pulsed low power: max. 50W pulse-pause ratio 1:2
Accuracy ±20%
he power figures relate to the average power output. he maximum power is
1200W.
Pulse frequency
0.5Hz, 1Hz
Accuracy ±5%
reatment time
0 ... 30 minutes
Accuracy ±5 seconds
Mains connection
230V, 50Hz
Fuses
2 x 5 AL, 250 V
Power consumption
max. 900VA
Protection class
I (according to EN 60601
-
1)
Applied part
ype B (according to EN 60601
-
1), adjustable radiator
head
Environmental conditions
emperature 10°C ... 30°C
Humidity 30% ... 75% without condensation
Air pressure 700hPa ... 1060hPa
Storage and transport
emperature 0°C ... 50°C
Humidity 10% ... 90% without condensation
Air pressure 700hPa ... 1060hPa
only in original packaging
Dimensions
33cm x 42cm x 72cm (without radiator head and cruciform base)
47cm x 50cm x 83cm (without radiator head)
Weight
38.5
kg including radiator head
Disposal
he device or parts thereof must not be disposed of in
household waste.
Contact the relevant authorities or recycling firms regarding disposal.
Note:
Storage and transport only in original packaging.
Subject to technical changes.

Cleaning
Disinfection
10
Page 14
Before starting
any maintenance and cleaning measures the device must always be
switched off at the main switch and the mains cable must be disconnected.
Make sure that during cleaning and disinfection no liquids penetrate the device. Do
not use sprays.
If during cleaning or disinfecting liquid penetrates the device, please put the device
out of service, protect it from being used again and contact your service
representative.
Make sure that when cleaning and disinfecting the labelling of the device (such as
warnings, labels of control devices, identification plate) is not damaged.
he device and its applied part are considered as uncritical in relation to hygiene
when used on non-injured and healthy skin.
Housing / adjustable
radiator head
In the
event of visible contamination, the housing and all cables can be cleaned
using commercially available alcohol-free plastic cleaners. Wipe the surface until the
dirt is removed, using a soft cloth soaked according to the specifications of the
manufacturer of the cleaning agent but not dripping wet.
We recommend that disinfection is to be carried out at least once a week, as well as
if there is any indication of contamination. Consult with your hygiene specialist when
doing so. Always perform cleaning prior to disinfection.
Housing and the adjustable radiator head can be disinfected using disinfectant
wipes. Use a commercially available alcohol-free disinfectant for metal and plastic,
with bactericidal, virucidal and fungicidal properties. Observe the instructions for use
of the respective manufacturer. Wipe all surfaces using a soft cloth soaked
according to the specifications of the manufacturer of the disinfectant, but not
dripping, or with cloths pre-impregnated with disinfectant (wipes).
Also observe requirements for drying or post-cleaning, where applicable.
Never spray disinfectant directly onto the device. Do not allow liquid to
penetrate the device or plug connectors!
Do not immerse the device or parts thereof in liquid!
Do not carry out steam, gas or gamma-ray sterilisation.
If flammable solutions are used for cleaning and disinfecting, sufficient time must be
allowed for the solution to evaporate before using the device. Otherwise, it may lead
to inflammation.
Note:
Use the device only
in a hygienic environment.