User Manual ddRCompact™ Series

Chapter 3: Maintenance

Maintenance

Caution: US Federal Law restricts this device to use by or on the

order of a physician.

Mise en garde: Les lois fédérales des États-Unis limitent l'utilisation

de cet appareil à un médecin ou à un tiers agissant
sur son ordre.

Revision Date By Reason for Change

01 2008-10-14 SRCH / WOL First Official Release

This document is the English original version, edited and supplied by Swissray Medical AG.
All rights reserved by Swissray Medical AG.

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 User Manual ddRCompact™ Series
Chapter 3: Maintenance

TABLE OF CONTENTS

Section Page

3 Maintenance.............................................................................................. 3
3.1 Safety Checks according to the Medical Products Law.............................. 3
3.2 Preventive Maintenance ............................................................................. 4
3.2.1 Test by the User .................................................................................................... 4
3.2.2 Test by the Swissray Service Organization ........................................................... 5
3.2.3 Record of Service & Repair Works ........................................................................ 5
3.3 Saving of Data for the technical Support .................................................... 6
3.4 Cleaning ..................................................................................................... 6
3.5 Disinfection................................................................................................. 7

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 User Manual ddRCompact™ Series
Chapter 3: Maintenance

3 Maintenance

By taking these precautions, you maintain the operability and operational reliability of
the system.

As the user of an X-ray unit, you are obliged to take such precautions
according to the regulations for the prevention of accidents, the medical
products law and other regulations.

Maintenance consists of tests which the user can perform, and maintenance which is
performed under service agreements, Swissray service orders or by persons explicitly
authorized by Swissray.

As with any technical appliance, this X-ray equipment also requires

- proper operation,
- regular testing by the user,
- regular service and repair.

3.1 Safety Checks according to the Medical Products Law

The safety checks cover the operational reliability. They must be performed at least
every 2 years. These tests constitute part of our preventive maintenance under our
service agreements,

- visual inspection for completeness and apparent damages or defects as well as

soiling, sticking parts and wear and tear which may affect the safety,
- testing the necessary monitoring, safety, display and indicating systems,
- measuring the safety-relevant output parameters,
- checking the electrical safety as well as the operability of an internal energy
supply,

• PE earthing system
• Stand covers etc.
• Cable fixing
• Safety components

- for the particular product other special technical tests according to the generally
accepted standards of engineering practice,
- other necessary tests specified by the manufacturer,
- recording results and filling in the test reports in the X-ray system manual
(medical products logbook).

• All testequipment must be full fills CE, UL and FDA requirement

(IEC / EN 60601-1, UL 60601-1).

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 User Manual ddRCompact™ Series
Chapter 3: Maintenance

3.2 Preventive Maintenance

3.2.1 Test by the User

The user must check the X-ray equipment for apparent defects (see table 1).
If operational defects or other deviations from normal operational behavior occur, he
must switch off the X-ray equipment and inform the Service Organization. He may
only resume operation of the X-ray equipment when it has been repaired. Operation
using faulty components may lead to increasing safety risk or unnecessarily load
radiation.

Interval Scope Method

According to X-ray Constancy check According to
regulations X-ray
regulations
Daily After switching on the X-ray equipment, Inspection by the
check the function of the movement stop user
button and sensors.
Daily X-ray equipment start-up test with X-ray test Inspection by the
(just a recommendation) phantom user
Daily Defective indication lights, damaged Inspection by the
components, labels and warning signs user
Daily Irregularity of the display (flickering, Inspection by the
breakdown) user
Weekly All cables and terminals (damage, Inspection by the
breakdown) user
Table 1

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 User Manual ddRCompact™ Series
Chapter 3: Maintenance

3.2.2 Test by the Swissray Service Organization

X-ray equipments contain mechanical components such as drive chains, gear rods,
gears etc., which are subjected to wear and tear due to operation. They include
means of suspension for heavy components (e.g. detector, X-ray tube etc.). After a
certain period of operation the safety of the suspension may be impaired by wear and
tear.
The correct setting of the electromechanical and electronic assemblies influences the
functioning, image quality, electrical safety and exposure of the patient and medical
personnel to radiation.

Swissray recommends:

- Perform the tests indicated in the table 1 on a regular basis.

- Have the X-ray equipment serviced by Swissray’s Service Organization at

least once a year. You must have heavily used X-ray equipment subjected
to maintenance more frequently.

In this way you avoid endangering the patient and you meet your obligations.
By entering into a service agreement with Swissray you maintain the value and safety
of your X-ray equipment. All the necessary maintenance, including the safety tests for
the purpose of preventing hazzards and the necessary settings for optimum image
quality and minimum exposure to radiation, is performed at regular intervals.
Swissray agrees on these intervals with you, taking the legal requirements into
account.

Faulty components which affect the safety of the X-ray

CAUTION
equipment must be replaced by genuine spare parts!

Les composants défectueux ayant un impact sur la sécurité

MISE EN
de l'équipement radiologique doivent être remplacés par
GARDE
des pièces de rechange authentiques !

3.2.3 Record of Service & Repair Works

Service and repairs must be entered in the medical products logbook, including the
following data:

- type and scope of work,

- if necessary, details of any change to ratings or the working zone,
- data, person performing the work, signature.

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 User Manual ddRCompact™ Series
Chapter 3: Maintenance

3.3 Saving of Data for the technical Support

Whenever you have the opinion to have discovered a technical problem, we will ask
you immediately to store the current supervisor state with help of the function Save
for Service. All available relevant data to analyse the problem (log file, concerned
picture etc) will be stored.

Via a service screen the service engineer can use these data for evaluating rarely
occurring problems or correcting adjustments.
After storing data for service, the respective service office should be informed.

• Open the concerned image

• Move the mouse pointer to the button
Save for Service and click once with
the left mouse button.

The data are stored and can be read out by the

customer service.

3.4 Cleaning

Clean the X-ray equipment with a damp cloth. Use only a mild detergent.

Never use any corrosive, solvent or abrasive detergents or polishes!

- Before cleaning the X-ray equipment, disconnect the equipment from the mains.

CAUTION After power off, capacitors may still be live 4 hours!

MISE EN Le condensateur peut rester sous tension 4 heures après

GARDE l'extinction du système !

- Ensure that no water or other liquids can enter the X-ray equipment. This
precaution prevents electrical short-circuits and corrosion forming on
components.

- Wipe enameled parts and aluminium surfaces only with a damp cloth and mild
detergent and then rub with a dry woolen cloth.

- Rub down chrome parts with a dry woolen cloth only.

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 User Manual ddRCompact™ Series
Chapter 3: Maintenance

3.5 Disinfection

The method of disinfection used must comply with the legal regulations and guide-
lines regarding disinfection and explosion protection.

Never use any corrosive, solvent or aerially disinfectant!

If you use disinfectants which form explosive mixtures of

CAUTION gases, these must first have evaporated before you switch
the X-ray equipment on again!

Si vous utilisez des désinfectants constituant des

MISE EN mélanges de gaz explosifs, vous devez attendre qu'ils se
GARDE soient évaporés avant de pouvoir remettre en marche
l'équipement radiologique!

- Before cleaning the X-ray equipment, disconnect the equipment from the mains.

CAUTION After power off, capacitors may still be live 4 hours!

MISE EN Le condensateur peut rester sous tension 4 heures après

GARDE l'extinction du système !

- You may disinfect all parts of the X-ray equipment, including the accessories
and connecting cables by wiping only.

- Disinfection by spraying is not recommended because the disinfectant may

enter the X-ray equipment.

- If you perform room disinfection with an atomizer, you must first disconnect the
X-ray equipment from the mains. When the X-ray equipment has cooled down,
cover it carefully with a plastic sheet. When the mist of disinfectant has
subsided, you can remove the plastic sheet and disinfect the X-ray equipment
by wiping.

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