Service Manual

MFG-03

Z Field Dual

StimSureTM

Zimmer MedizinSysteme GmbH Tel.: 0731 / 9761-0 [email protected]

Junkersstraße 9 Fax : 0731 / 9761-118 www.zimmer.de
89231 Neu-Ulm
 Valid as of
Service Manual MFG-03 23.10.2019

Document history

Vers. Reason for Change Change Description Effective from

A -- Initial Release 23.10.2019

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Table of content
1. Safety Instructions 3
1.1. General information 3
1.2. How to use this Service Manual 4
1.3. Safety symbols/pictograms in the documentation 4
1.4. Safety Instructions 5
1.4.1. Precautions for electrical safety 5
1.5. Cautions 6
2. Device description 7
2.1. General Description 7
2.1.1. Front view 7
2.1.2. Rear View 8
2.1.3. Applicator Z Field Dual Fehler! Textmarke nicht definiert.
2.1.4. Applicator StimSureTM Fehler! Textmarke nicht definiert.
2.1.5. Display and Control Panel Z Field Dual and StimSureTM 9
2.2. Mechanical Construction 10
2.2.1. Overview 10
2.2.2. Diagrams / Figures 11
2.3. Electronic Construction - overview 12
2.3.1. Diagrams / Figures 12
2.4. Software 13
2.4.1. Installation 13
2.4.2. Updating Firmware 13
2.5. Technical Data 19
3. Maintenance 19
4. Routine Inspection and Cleaning 19
4.1. Routine Inspection 19
4.2. Cleaning 20
5. Troubleshooting 20
5.1. Error Messages 20
5.1.1. Over Temperature 20
5.1.2. Applicator Error 21
5.1.3. Cooling Module Life Time 21
5.2. Faults / Remedys 22
5.2.1. Power DBT B/D AC voltage check 22
5.2.2. SMPS voltage check 22
5.3. “APPLICATOR ERROR” / Transducer Message pops up (Instrument: DVM) 23
5.3.1. Applicator cable check 23
5.4. “Over Temperature” Message pops up 24
5.4.1. Visual examination of oil circulation in start mode 24
5.4.2. Check radiator fan if oil circulation is in progress 24
5.4.1. Check cooling B/D if oil circulation is failed 25
5.5. Absence of Magnetic Output Power (Instrument: DVM, HV-Probe) 26
5.5.1. Check the voltage of analog B/D, HV control. (J9) 26
5.5.2. HVP Check (Check after separating HV Fuse (2A)) 26
5.5.1. HV bakelite check (HV diode check) 27
5.5.1. Discharge capacitance check 28
5.5.2. Applicator a’ssy check 28
6. Replacement of Components 29
6.1. Safety Notice / Warning 29
6.2. Spare Part Handling 29
6.3. Open Housing 29
6.3.1. Assembly/Disassembly 30
6.4. Close Housing 30
6.5. Replacement of components 30
7. Returning a device 31
7.1. Packaging 31
8. Repairing Printed Circuit Boards 31
9. Incidents 31
10. Annexes 31

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1. Safety Instructions
Zimmer MedizinSysteme GmbH as the manufacturer of electro medical devices can only accept liability for the safety
and reliability of the device under the following conditions:
 The electrical installation conforms to the requirements specified for operation of the device
 The device is operated as specified by the instructions for use
 Extensions, new settings or changes are only carried out by persons authorized by Zimmer MedizinSysteme
GmbH.
Zimmer MedizinSysteme GmbH reserves the right to make changes to delivery options and technical features. Contract
service partners are responsible for all repairs that they conduct.
Screws that must be removed to open the housing are protected by a special warranty seal. Only authorized persons are
permitted to remove them. If the seal is missing or has been manipulated, the device will no longer be under warranty.
The information in the service documentation is the property of the manufacturer and intended for internal use by our
technicians only. Publication of this information or distribution to unauthorized persons is prohibited. If the service
contract is canceled, the technician(s) is/are required returning the service documentation to Zimmer MedizinSysteme
GmbH.
1.1. General information
This service manual is written for effective maintenance of StimSureTM and ZFieldDual.
The functions and precautions must be thoroughly observed to guarantee the safe use and post management.
For the safe use and stable performance of the device, be sure to thoroughly understand the details of functions,
instructions, and maintenance included in this Service Manual before using the device.
The Assembly, Expansion, Repair of this machine must be executed by personnel authorized by Zimmer
MedizinSysteme GmbH. It is prohibited to copy, translate, or digitize the entire or part of this Service Manual without
prior consent of Zimmer MedizinSysteme GmbH.
The Assembly, Expansion, Repair of this machine must be executed by personnel authorized by Zimmer
MedizinSysteme GmbH. It is prohibited to copy, translate, or digitize the entire or part of this Service Manual without
prior consent of Zimmer MedizinSysteme GmbH.
This Service Manual may include misprinted letters or technological flaws, and those can be corrected without prior
notice.
Zimmer MedizinSysteme GmbH is not responsible for advantage/disadvantage occurred by assembly /disassembly of
this product, conducted by personnel without relevant education.
Zimmer MedizinSysteme GmbH is not responsible for advantage/disadvantage occurred by assembly /disassembly of
this product, conducted by personnel without relevant education.
This Service Manual consists of independent chapters; thus some contents can be redundant.
Manufacturer:
Zimmer MedizinSysteme GmbH
Junkersstraße 9
89231 Neu-Ulm
Germany

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1.2. How to use this Service Manual

This Manual includes contents of highly-intensive medical electromagnetic generator Z Field Dual and StimSureTM
 This Manual consists of independent chapters; thus, some contents can beredundant.
 This Manual is a guide for stable performance of Z Field Dualand StimSureTM.
 This Manual includes operating instructions of the device.
 The details of this Manual must be carefully observed, and DO NOT throw away this service manual.
 This Manual includes error recovery procedures and setting method.

1.3. Safety symbols/pictograms in the documentation

When there is specific information in the Service Manual that needs to be emphasized for safety, the following terms and
symbols are indicated. All warnings and precautions shall always be observed. The manufacturer or agent of the product
is not responsible for any personal/material damage caused by erroneous use, operation for purposes other than its
intended objective and negligence of product maintenance.

This symbol indicates in the instructions for use for dangers to patient, user or third

Caution ! This symbol indicates a warning for possible harm to the unit.

See user manual

No pacemaker

No pushing

No sitting

Warning magnetic field

Serial number

Article number

Manufacturer

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Manufacturer Date

This symbol indicates dangers/warning on the device

This symbol indicates warning for electricity if the device housing is removed

Disposal of electrical and electronic equipment as well as used batteries and accumulators.

This product must not be disposed of with household waste

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.

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.

1.4. Safety Instructions

1.4.1. Precautions for electrical safety

 The rated power for this equipment is 220-240V 50/60Hz

 Confirm that all the connecting sections (power line or peripheral equipment) are adequately
connected to the equipment.
 Confirm that the equipment is completely grounded.
 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.
 Make sure to inquire our technology team before connecting instruments not mentioned in this
Service Manual.

 To avoid electrical noise during use, the equipment shall be installed at a significant distance form
any generator, X-ray equipment, broadcasting device, mobile electric wire, and so forth.

 An independent power circuit is essentially required, and sharing of power with other electronic
devices not recommended.
 Installed equipment shall be subject to regular safety inspections from specialized personnel
Caution ! authorized by the manufacturer.
 For electrical safety, equipment shall always be connected to a safely grounded power supply for
operation.

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 Do not use the equipment in parallel with other electronic medical equipment.
 Do not use the equipment near flammable anaesthetic or solvent.
 Do not place items that can cause danger to the equipment, such as oils, chemicals etc. near the
equipment.
 When equipment is operated, do not use any mobile phones, radio sets, mobile radio transmitters,
wireless toys, etc. in the proximity of the equipment.
 During the operation of the equipment, the patient shall not take drinks, water, etc. which can
influence the equipment.
 During the operation of the equipment, if any abnormal reaction or symptom is witnessed, stop using
the device immediately and contact our engineers
Classifications
Protection type and level for electric shock: Class I, Type BF
Electromagnetic compatibility (EMC) test standard: Type 2, class A
This device is a medical device.

1.5. Cautions
 Installation and re-installation of equipment shall always be performed by specialized personnel
authorized by the manufacturer.
 Repair or installation of equipment shall only be performed by the specialized personnel authorized
by the manufacturer and as such, all arbitrary disassembly/assembly of equipment by the user is
absolutely prohibited.
 For electrical safety, equipment shall always be connected to a safely grounded power supply for
operation.
 The operator and manager of equipment shall thoroughly understand the Service Manual, and it must
be kept in the close proximity of the equipment.
 To prevent safety accidents and ensure adequate maintenance, place the safety marks, guide
phrases and regular inspection table provided with the equipment at an easily visible location near the
equipment.
 As a fan is installed in the body of the equipment for air circulation, remove curtains or any other
objects which can block the flow of air from near the equipment.
 From the surroundings of the location where equipment is installed, remove water, alcohol, flammable
materials, and so forth.
 As a strong magnetic field is generated around the magnetic field generating section, equipment
operation technicians, assistants, and patients must not hold any items which can be affected by the
magnetic field.

 Items such as wristwatches, mobile phones may be damaged by magnetic fields, so please be
careful and keep them separately

 When equipment is in operation, do not use any mobile phones, radio sets, mobile radio transmitters,
wireless toys, etc. in the proximity of the equipment.
 During the operation of the equipment, the patient shall not take drinks, water, etc. which can
influence the equipment.
 Do not handle the device with wet hands.

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2. Device description
2.1. General Description
2.1.1. Front view

1. Applicator left (Channel1)

2. Applicator right (Channel2)
3. Display
4. Central control knob
5. Control unit
6. Swiveling wheels

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2.1.2. Rear View

7. Connectors for applicator tubes

8. Cooling
9. Power connector
10. Power switch
11. Serial no / Identification plate

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2.1.3. Display and Control Panel Z Field Dual and StimSureTM

1 1

2
2

No. Name Function Remarks

1 Encoder Change settings Setting timer, frequency and intensity
Touch Panel Touch Panel Monitor for displaying and
2 --
LCD changing settings

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2.2. Mechanical Construction

2.2.1. Overview

SMPS HVPS
Display board Analog board Switched Mode Power High Voltage Power
Supply Supply

HV module
Power DBT board Oil tank module Discharger module
Incl. Gateboard and SCR

Cooling Board Applicator 1/2 Radiator module Fuse board

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2.2.2. Diagrams / Figures

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2.3. Electronic Construction - overview

2.3.1. Diagrams / Figures

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2.4. Software
2.4.1. Installation
Software is stored as a “CR”-File at the SD-Card of the device:

cr.exe

2.4.2. Updating Firmware

Install AVR-Studio 4 on your computer:
1. Click “AVR”.

2. Click “Cancel“

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3. Select appropriate device and signature bytes type from the drop-down list for the device to be main.
Select “ATmega128A”.

4. Select appropriate “Program Mode and Target Settings” type from the drop-down list for the device to
be main. Select “ISP mode”. Click “Settings.”

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5. Select “460.8 KHz”

6. Click “Write”.

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7. Click “Close”

8. Click “Fuses”

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9. MFG-03 Firmware Program

10. Open “hex-file”

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11. Click “Program” when you are done with the preparation

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12. Connector is separated from the board after checking the program installation is completed.

2.5. Technical Data

See the respective chapter in the corresponding Instructions for Use.

3. Maintenance
 Both the Z FieldDual and the StimSureTM and its accessories can be maintained through a variety of methods.
 Avoid contamination or damage of the equipment by following recommended procedures.
 Maintain the main body by wiping with a soft cloth moistened with alcohol on a monthly basis. DO NOT use
lacquers, thinners, ethylene and oxides.
 DO NOT submerge any section of the equipment in any form of liquid or detergent.
 Also, no liquid must be allowed to enter the equipment or accessories.

4. Routine Inspection and Cleaning

4.1. Routine Inspection
 The covering of power line of equipment, Applicator connecting line, etc. shall not be peeled off and internal
lines shall not be exposed, and shall not be damaged by impact from outside.
 There shall be no trace of oil leakage from Applicator.
 Disinfect the outside of the device so that there is no foreign material.
 The button for equipment operation, etc. must not shake.
 The various parts attached to equipment must not shake.

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4.2. Cleaning
To avoid the risk of electric shock; the device´s main plug must be disconnected from the mains supply before
performing any maintenance, cleaning or disinfection activities.
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 unit out of service, protect it from
being used again and contact your service representative.

Make sure that when cleaning and disinfecting the labels of the device (such as warnings, labels of control
devices, identification plate) are not damaged.

The device and its applied part are considered ‘non- critical’ in relation to hygiene when used on non-injured
and healthy skin.

Cleaning: In the event of visible contamination, the housing, the applicator and all cables can be cleaned
using commercially available soft 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.
Disinfection: We recommend that disinfection to be carried out at least after every patient, at the end of every
day and as well as in the event of evidence of possible contamination. Consult with your health professional
when doing so. Always perform cleaning prior to disinfection.
Housing and applicator can be disinfected using disinfectant wipes. Use a commercially available alcohol-free
disinfectant for metal and plastic, with bactericidal, veridical and fungicidal properties. Observe the application
instructions of the manufacturer. Wipe all surfaces using a cloth soaked according to the specifications of the
manufacturer of the disinfectant, but not dripping, or with cloth pre-impregnated with disinfectant (wipes).
If applicable, also observe requirements for drying or post-cleaning.
Caution: If flammable solutions are used for cleaning and disinfection,sufficient time must be
allowed for the solutions to evaporate before using the device. Otherwise, it may lead to
inflammation!

5. Troubleshooting
5.1. Error Messages
5.1.1. Over Temperature
Z Field Dual / StimSureTM is a device that generates a magnetic field by applying a high current to an Applicator.
As heat is generated from the Applicator using the high current used to create the magnetic field, cooling is
performed by circulating the cooling oil inside the Applicator. If the Applicator is used in a tilted position, the
cooling oil will not reach all sections of the Applicator, and injury or stoppage of operation can occur. Because of
this, it is recommended to place the Applicator in a horizontal position. When Applicator is overheated, the
operation is temporarily suspended and the “Over Temperature” message as shown below is displayed. When
this message is displayed, put the Applicator away from the patient for a while (Do not turn off the equipment)
until the message disappears and the equipment returns to a normal state.

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It is highly recommended to use the Applicator in a horizontal position.

5.1.2. Applicator Error

Z Field Dual / StimSureTM always checks the connection of the Applicator cable. If the cable is disconnected or
damaged, the message is shown below. In this case, equipment cannot be used anymore, and the user must
contact authorized personnel of our local distributor maintenance.

The equipment always checks the connection state of the cable connected to the
Applicator.

5.1.3. Cooling Module Life Time

Z Field Dual / StimSureTM uses an oil pump for cooling. This component is a consumable component, with 5,000
hours of warranty. After 5,000 hours, “Cooling Module” message is displayed as below.

This is not a failure, is a notification of maintenance. Touch the panel and the device will be back to normal
state. Replacing the component is recommended to prevent unexpected failures. Contact us or agents
authorized by Zimmer MedizinSysteme GmbH.

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5.2. Faults / Remedys

Measuring Instruments:
Digital Multimeter: Output Voltage Check:

5.2.1. Power DBT B/D AC voltage check

AC Power is applied to J4 by turning on the power with every cable removed except J4(AC IN)
1. Check INLET fuse, noise filter, I/O switch if the AC power is not applied in J4.
2. The screen must be turned on when the power is on with J3(SMPS) cable plugged (AC power in J3 must be
confirmed in advance)
3. Check SMPS output voltage if the screen does not turn on.
Replace HVP if the screen turns on

5.2.2. SMPS voltage check

1. Replace SMPS if the SMPS input AC power is applied while the output is not applied.
2. Check analog B/D, J4 if the SMPS output voltage is applied while the screen does not turn on.
3. Replace analog B/D if the voltage is not applied to analog B/D J4(5V DC.)
4. Voltage is applied to analog B/D J4 (5Vdc), check LCD and display B/D if the screen is not appeared.

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5.3. “APPLICATOR ERROR” / Transducer Message pops up (Instrument: DVM)

5.3.1. Applicator cable check

The resistance between No.4 and No.8 must be within 10kΩ~13kΩ while J12(CH1) and J15(CH2) connectors
are unplugged.
 Check Applicator A’ssy if the measured resistance is not displayed.
 Replace analog B/D if the resistance is within normal range.
1. If the resistance is within normal range, Replace CH1 Applicator cable a’ssy
2. If the measured resistance is not displayed, Replace CH1 Applicator head

1. If the resistance is properly measured, Replace CH2 Applicator cable a’ssy

2. If the resistance cannot be measured, Replace CH2 Applicator head

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5.4. “Over Temperature” Message pops up

Symptom caused by heat generated in the Applicator if the oil circulation is in bad condition.

5.4.1. Visual examination of oil circulation in start mode

5.4.2. Check radiator fan if oil circulation is in progress

Check cooling B/D if the fan is not working.

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5.4.1. Check cooling B/D if oil circulation is failed

(Check in start mode, at intensity 0% )

1. 24V must be applied to J1.

Replace analog B/D if the voltage is not applied.
2. 24V must be applied to each no.1 pin of J9, J10, J11, J12, J13 (Red wire).
Replace the radiator fan if the fan is not working while the voltage is applied
Replace cooling B/D if the voltage is not applied.
24V must be applied to each no.1 pin, meanwhile 5V must be applied to each no.6 pin of J2, J3, J15.
Replace cooling B/D if the voltage is not applied.
Replace oil container module if the oil is not circulated while the voltage is applied.

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5.5. Absence of Magnetic Output Power (Instrument: DVM, HV-Probe)

5.5.1. Check the voltage of analog B/D, HV control. (J9)

1. If the voltage cannot be changed by changing intensity Replace analog B/D.

2. If the voltage can be changed by changing intensity Check HVP

5.5.2. HVP Check (Check after separating HV Fuse (2A)

1. 2A fuse disconnection check

Replace the fuse if the fuse is disconnected or the cables inside the glass tubes are discolored.
2. The voltage should be around 390V(±10%) when measure at Intensity 2%.
(Caution! separate HV fuse before measurement)
Replace HVP if HVP output voltage is not displayed.

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Voltage distribution table. Intensity level:

Warning! Make sure NOT TO exceed 1450 V at intensity 100%

5.5.1. HV Module check (HV diode check)

(Check after separating Fuse (2A)
If diode check does not meet in forward (0.8V±20%) and reverse (OL). Replace HV-module

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5.5.1. Discharge capacitance check

Check the capacitance (volume ±10%)

(The output intensity may be weak if the capacitance is low)
Replace capacitor module if the capacitance is not displayed.

5.5.2. Applicator a’ssy check

Measure the resistances of each end of CH1 and CH2 Applicator cable, which should be around 0Ω.
Replace Applicator a’ssy if the resistance equals or more than 1Ω.
When resistance value is measured approximately 0Ω at the high voltage terminal of CH1, CH2 Transducer
Head (short state), replace the transducer cable.

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6. Replacement of Components
6.1. Safety Notice / Warning
Do not touch modules or parts in the device when working on an open device and the power cable plugged in.
Electrical parts, cables and wires may have a voltage up to high voltage. Unplug power cable before opening and
closing the device.
6.2. Spare Part Handling
Electronic spare parts, such as boards, parts must be handled in accordance with the general ESD guidelines
(protection against electrostatic discharge).
The electrical parameters of new modules (e.g. CPU, etc.) supplied by the manufacturer are preset at the factory.
All boards must be visually inspected before installation (shipping damage, etc.).
Faulty board must be repaired by the manufacturer only. After replacing a module, the faulty part must be labeled
with the serial number of the device and returned to the manufacturer with the service report (see Annex).

Faulty board must be repaired by the manufacturer only. After replacing a module, the faulty part must be labeled
with the serial number of the device and returned to the manufacturer with the service report (see Annex).
6.3. Open Housing
Unplug power cable from power source.
Parts of the High Voltage circuit may still be loaded with voltage up to 1450V !
To avoid the risk of electric shock; the device´s main plug must be disconnected from the mains
supply. Before performing any maintenance, cleaning or disinfection activities, the capacitors must
be discharged.

Parts of the Cooling circuit may still be very hot !

Use protective gloves or wait until the device has cooled down.

Zimmer MedizinSysteme GmbH - Junkersstraße 9 - 89231 Neu-Ulm – Germany

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6.3.1. Assembly/Disassembly

6.4. Close Housing

Before closing the housing always check the following:
• The displays and keyboard with connectors are correctly installed
• Correct fuses are installed
• All boards and other components are fastened in place
• No loose parts (such as screws) in the housing
• All foam parts installed
6.5. Replacement of components
The device is assembled in a modular structure. The modules are to be exchanged as displayed in chapters 6.3
and6.3.1, only by trained technicians.

Zimmer MedizinSysteme GmbH - Junkersstraße 9 - 89231 Neu-Ulm – Germany

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7. Returning a device
7.1. Packaging
Every unit that is sent to the manufacturer for service must be packed in the original packaging to prevent any
damage during shipping. Always include a detailed description of any faults; therefore use the service report in
Annex 2.

8. Repairing Printed Circuit Boards

Faulty boards must be repaired by the manufacturer only. After replacing a module, the faulty part must be labelled with
the serial number of the device and returned to the manufacturer with the service report form (Annex 2).

9. Incidents
Zimmer MedizinSysteme GmbH is required to record incidents of any type. Please report all incidents (e.g. electric
shock, burns etc.) immediately by phone or e-mail. We will contact you regarding further processing.

10. Annexes
Annex 1: Spare Part List
Annex 2: Service Report
Annex 3: Test Report
Annex 4: Engineering Change Notices

Annexes can be changed without further notice.

Zimmer MedizinSysteme GmbH - Junkersstraße 9 - 89231 Neu-Ulm – Germany

Version A Page 31 of 31
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Service Manual MFG-03 – Annex 1 22.10.2019

Spare Part List

HVPS – High Voltage Power

54209203
Module

HV – Power Charge / Re-

54209220
Charge Capacitor Module

HV – Capacitor Module 54209221

Oil Cooling Tank Module 54209205

SMPS – Switched Mode

54209206
Power Supply

Cooling Board 54209207

Analog Board 54209700

Zimmer MedizinSysteme GmbH - Junkersstraße 9 - 89231 Neu-Ulm – Germany

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Display Board 54209209

Power DBT Board 54209210

Fuse Board
54209238
(without Fuses)

AC Filter 54209218

Radiator Module 54209222

Applicator –StimSure
54209601
(incl. Cable)

Zimmer MedizinSysteme GmbH - Junkersstraße 9 - 89231 Neu-Ulm – Germany

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Applicator ZFieldDual
54209211
(incl. Cable)

Applicator Upper Cover

54209602
StimSure

Applicator Upper Cover

54209232
ZFieldDual

Main Cable (Applicator) 54209223

Touch Panel
54209600
(incl. LCD-Module)

SCR (Silicon Controlled

54209226
Rectifier)

Zimmer MedizinSysteme GmbH - Junkersstraße 9 - 89231 Neu-Ulm – Germany

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Line Filter 54209227

Oil Pump 54209228

LCD (8”) 54209214

Inlet Socket & Clamp 54209242

Mains Fuse
28012000
12,5AT (5x20mm)

Fuse 3AT 28500005

*For StimSureTM, spare parts without Zimmer branding are available; please contact the service department of Zimmer
MedizinSysteme GmbH for the respective article numbers.

Zimmer MedizinSysteme GmbH - Junkersstraße 9 - 89231 Neu-Ulm – Germany

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Service Manual MFG-03 – Annex 2 22.10.2019

Service Report

Serial no. of the device: ...........................................

Software Version: ...........................................
Date/signature: ...........................................
Name: ...........................................

Customer Information

Customer: .............................................................. Date: ............................

Description of fault:

................................................................................................................................................................................................

................................................................................................................................................................................................

................................................................................................................................................................................................

................................................................................................................................................................................................

Occurrence of fault: once several times frequent always

............................................................................................................

Under the following conditions: after switching on with a warm device

during treatment (after ………….. minutes)
Other:
....................................................................................................................................………….............................................
Special environmental conditions:

Humidity:............... Temperature:............... Power connection:........…………………………..................................................

Other:.............................................................................................................................................................….....................

Prior repairs and installed spare parts (name, serial number):

................................................................................................................................................................................................

................................................................................................................................................................................................

Other notes:..........................................................................................................……………..............................….............

Zimmer MedizinSysteme GmbH - Junkersstraße 9 - 89231 Neu-Ulm – Germany

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Service Manual MFG-03 – Annex 3 22.10.2019

Z Field Dual / StimSureTM – Safety Check / Test Report (According to IEC 60601-1/IEC 62353)
Protective Class: I (Protective Earth)
Applied Part: Typ BF
Mains Connection: Detachable Mains Cable
Device Serial Number: _____________________________ Measuring Equipment: ________________________________

Accessories: __________________________________________________________________________________________

 Periodic Safety Inspection  Check after Repair  Check before Initial Operation

Visual Inspection: n.O.K. O.K.

Damage, Contamination, Wear out  
Caption and Safety Labels are complete and legible  
Power cord without visible damage  
Applicators and connection cables  
Mains fuse (corresponds to specification on the label)  
Electrical Safety:
Protective Ground Resistance (max. 0,2 X) Measured Value: _______________ X  
Earth Leakage Current NC (max. 500µA) Measured Value: _______________ µA  
Earth Leakage Current SFC (max. 1000µA) Measured Value: _______________ µA  
Patient Leakage Current NC (max.100 µA) Measured Value: _______________ µA (Foil)  
Patient Leakage Current SFC (max. 500µA) Measured Value: _______________ µA (Foil)  
Function Test:
Encoder, Touch Function  
Display, Backlight  
Mains Switch  
Magnetic Flux (Both Transducers, Subjective Self-Test – Observe Safety Warnings!)  
Safety / Caution Measures Readable / Audible Signaling
Acoustic Signal  
Deficiencies / Comment:
________________________________________________________________________________________________
________________________________________________________________________________________________
________________________________________________________________________________________________
Comprehensive Assessment:
 No safety or function deficiencies found
 No direct risk. The discovered defects can be remedied shortly.
 The device must be taken out of operation until the defects have been repaired
 Device does not correspond to the requirements.
 Modifications / Replacement of Components / Decommissioning of the Device is recommended

Tested by: ___________________________ Date: ____________________ Signature: ______________________

Zimmer MedizinSysteme GmbH - Junkersstraße 9 - 89231 Neu-Ulm – Germany
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Service Manual MFG-03 – Annex 4 22.10.2019

Engineering Change Notices

No changes available

Zimmer MedizinSysteme GmbH - Junkersstraße 9 - 89231 Neu-Ulm – Germany

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