Sola 300 Instruction for Use Edition 3 Aug 2012

Working with these instructions for use The title of the main chapter in the header line helps with quick orientation and navigation. The instructions for the user combine text and illustrations, providing a comprehensive overview of the system. The information is presented as sequential steps of action, allowing the user to learn directly how to use the device. The text provides explanations and instructs the user step-by-step in the practical use of the product, with short, clear instructions in easy-to-follow sequence. 1

Consecutive numbers indicate steps of action, with the numbering restarting with “1” for each new sequence of actions.

 Bullet points indicate individual actions or different options for action. –

Dashes indicate the listing of data, options or objects.

(A) Letters in parentheses refer to elements in the relevant illustration. The illustrations show the relationship between the text and the device. Elements mentioned in the text are highlighted. Unnecessary details are omitted. A Letters denote elements referred to in the text.

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Instructions for use Sola 300

Trademarks –

Sola®

–

DrägerService®

are trademarks owned by Dräger.

Definition of the safety notes The safety notes in these instructions for use are designed and defined as follows: WARNING A WARNING statement provides important information about a potentially hazardous situation which, if not avoided, could result in death or serious injury. CAUTION A CAUTION statement provides important information about a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or in damage to the equipment or other property. NOTE A NOTE provides additional information intended to avoid inconvenience during operation.

Symbols For explanations see chapter "Symbols" on page 12.

Instructions for use Sola 300

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Definition of target groups For this medical product, users, service personnel, and experts are defined as target groups. These target groups have received training on the medical product and have the required training and knowledge to use, install, reprocess, maintain, or repair the medical product. The medical product may only be used, installed, reprocessed, maintained, or repaired by the defined target groups.

Users Users are persons who are permitted to use the medical product in accordance with its intended use.

Service personnel Service personnel are persons who are responsible to the operator for maintaining the medical product. Service personnel are persons who are permitted to install, reprocess, or maintain the medical product.

Experts Experts are persons who are permitted to perform repairs or complex maintenance work on the medical product.

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Instructions for use Sola 300

Contents

Contents For Your Safety and that of Your Patients . .

6

Intended Use...

9

Versions... Description...

9 9

Overview... 10 Symbols... 12 Preparation... 13 Operation... 17 Sola 300... 17 Sola 300 Mobile... 18 Service Work... 19 Replacing bulbs... 19 Adjusting the braking force... 23 Fault – Cause – Remedy... 24 Cleaning and disinfection... 25 Maintenance... 28 Overview... Definition of maintenance terms... Inspection... Service... Repair...

28 28 29 30 31

Disposal... 32 Safety information... 32 Disposal of the medical device... 32 Technical Data... 33 Accessories List... 35

Instructions for use Sola 300

5

For Your Safety and that of Your Patients

For Your Safety and that of Your Patients

Strictly follow the instructions for use

Accessories

WARNING Strictly follow these instructions for use.

WARNING Only accessories indicated in the list of accessories have been tested and approved to be used with the device. We therefore urgently recommend only using the device in combination with appropriate accessories. Otherwise, the correct functioning of the device may be compromised.

Any use of the product requires full understanding and strict observation of all portions of these instructions. The device is only to be used for the purpose specified under "Intended use" on page 9. Observe all WARNING and CAUTION statements throughout these instructions for use and all statements on device labels. Non-observance of these instructions constitutes non-authorized use of the medical device.

Maintenance WARNING The device must be inspected and serviced regularly by experts. Repair of the device may also only be carried out by experts.

Disconnection of all poles WARNING When installing the light system, the operator must ensure that the disconnection of all poles is guaranteed for maintenance and service. The necessary switching element is not included in the delivery of Dräger light systems.

Dräger recommends that a service contract be obtained with DrägerService and that all repairs also be carried out by them. Dräger recommends that only authentic Dräger repair parts be used for maintenance. Otherwise, the correct functioning of the device may be compromised. Regularly carry out technical safety inspections on the device, observe chapter "Maintenance".

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Instructions for use Sola 300

For Your Safety and that of Your Patients

Not for use in areas of explosion hazard

General WARNINGS and CAUTIONS

WARNING This device is neither approved nor certified for use in areas where combustible or explosive gas mixtures are likely to occur.

The following WARNING and CAUTION statements apply to general operation of the medical device.

Patient safety The design of the medical device, the accompanying literature, and the labeling on the medical device take into consideration that the purchase and use of the medical device are restricted to trained professionals, and that certain inherent characteristics of the medical device are known to the trained operator. Instructions, warnings, and caution statements are limited, therefore, largely to the specifics of the Dräger design.

WARNINGS and CAUTIONS specific to subsystems or particular features appear with those topics in later sections of these instructions for use or in the instructions for use of any product being used with this device. WARNING The device is intended for use by qualified medical personnel only. WARNING Risk of an electric shock! Do not open the housing of the device, except for the light head while replacing the bulb.

These instructions for use exclude references to various hazards which are obvious to a medical professional and operator of this medical device, to the consequences of medical device misuse, and to potentially adverse effects in patients with abnormal conditions. Medical device modification or misuse can be dangerous.

Instructions for use Sola 300

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For Your Safety and that of Your Patients

Note on EMC/ESD risk for the device function WARNING General information on electromagnetic compatibility pursuant to EMC/ESD declaration of the international EMC standard IEC 60601-1-2: Electromedical devices are subject to special precautionary measures concerning electromagnetic compatibility (EMC) and must be installed and put into operation in accordance with the EMC information included in the technical documentation. Portable and mobile RF communications equipment can affect medical electrical equipment.

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Instructions for use Sola 300

Intended Use

Intended Use Sola 300 (wall light and ceiling light) and Sola 300 Mobile (mobile light) This examination light is used in the patient environment to illuminate the body of the patient locally as well as support treatment and diagnosis. In case of failure, the treatment and diagnosis can be interrupted without any hazard. It is not intended to be used in operating rooms.

Versions Sola 300 –

Available as a ceiling-mounted or wall-mounted version.

Sola 300 Mobile –

Sola 300 Mobile available as a mobile examination light.

Description The Sola 300 examination light is a reflector light. A halogen bulb projects a light beam onto the treatment field via a reflector.

Instructions for use Sola 300

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Overview

Overview

Sola 300 wall light

Sola 300 ceiling light

A

A B

B C

C D

001

D A Wall bearing

E 002

B Swivel arm with spring arm C Sola 300 light head D Lateral handle

A Ceiling cover B Ceiling tube C Swivel arm with spring arm D Sola 300 light head E Lateral handle

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Instructions for use Sola 300

Overview

Sola 300 Mobile light

A

B C D

E

003

F A Sola 300 light head B Lateral handle C Spring arm D Tube E Trolley F Double castors with parking brakes

Instructions for use Sola 300

11

Overview

Symbols Symbol

Consult Operating Instructions

Description

A

Follow the instructions for use/assembly instructions Follow the instructions for use/assembly instructions

A 004

Caution!

Caution!

A Sola 300 rating plate Caution! Hot surface

B

Caution! Risk of tipping over

B

006

Caution! 5° slope 5°

B Sola 300 Mobile rating plate Note on disposal according to Directive 2002/96/EEC (WEEE) Manufacturer Date of manufacture

004

XXXX

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Instructions for use Sola 300

Preparation

Preparation

Check for operational readiness before each use

A

The Sola 300 is ready for operation if the checks were carried out successfully and without objections.

008

CAUTION Before each use, check the condition of the Sola 300 for: – Visible damage on the light head and arm system, – Present voltage supply, – Cleaning and disinfection of the Sola 300 in accordance with the stipulations of the hospital, see "Cleaning and disinfection" on page 25.

 Fold the spring arm (A) of the Sola 300 Mobile to the lowest position.

Sola 300 The Sola 300 versions – suitable for ceiling or wall installation – are fully assembled and can be operated immediately.

B

Sola 300 Mobile

CAUTION Danger of personal injury and equipment damage! Only move the Sola 300 Mobile in transport position (spring arm folded to its lowest position). Failure to observe may result in the Sola 300 Mobile tipping over.

Instructions for use Sola 300

009

Moving the Sola 300 Mobile to location of use

 To move the Sola 300 Mobile, only use the tube (B) on the trolley. The lateral handle on the light head is designed to be used exclusively to position the light head!

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Preparation

CAUTION Danger of personal injury and equipment damage!

CAUTION Danger of personal injury and equipment damage!

To move the Sola 300 Mobile, only use the tube on the trolley!

The light head must always point to the front if the Sola 300 Mobile is moved downwards on a ramp.

The lateral handle on the light head is designed to be used exclusively for positioning the light head!

When moving the Sola 300 Mobile light up a ramp, always pull the Sola 300 Mobile using the tube on the trolley.

 Only move the Sola 300 Mobile at walking pace. There is a risk of the Sola 300 Mobile tipping over at thresholds, uneven surfaces and ramps. Further reduce the transport speed. CAUTION Danger of personal injury and equipment damage! Only move the Sola 300 Mobile at walking pace.

010

There is a risk of the Sola 300 Mobile tipping over at thresholds, uneven surfaces and ramps. Further reduce the transport speed.

011

The "Warning: risk of tipping over" warning plate is located on the trolley.

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Instructions for use Sola 300

Preparation

Sola 300 Mobile at location of use

CAUTION Danger of personal injury and equipment damage! Make sure the power cable is safely routed. Do not move the double castors of the trolley over the power cable! CAUTION Danger of personal injury and equipment damage!

A 012

Do not rest on the spring arm!

1

Apply all four parking brakes (A) on the trolley.

CAUTION Danger of personal injury and equipment damage!

CAUTION Danger of personal injury and equipment damage!

Do not stand on the trolley.

Always apply all four parking brakes on the trolley of the Sola 300 Mobile at the location of use.

013

B

2

Connect the IEC connector of the power cord (B) to the trolley.

 Connect the power plug to a grounded wall outlet.  Make sure the power cable is safely routed.

Instructions for use Sola 300

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Preparation

014

5°

The "Warning: 5o slope" warning plate is located on the trolley.

015

5°

CAUTION Danger of personal injury and equipment damage! Do not tilt the Sola 300 Mobile more than 5o! Failure to observe this may result in the Sola 300 Mobile tipping over.

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Instructions for use Sola 300

Operation

Operation WARNING Danger of personal injury and/or equipment damage!

CAUTION Danger of personal injury and equipment damage!

Do not place objects on the light heads or hang them on the arm system. These objects can fall down into the treatment field.

When positioning the Sola 300, do not use force to pull the arm system beyond the end stops.

Do not hang heavy loads (e. g., leaning body weight) on the arm system. Damage may result to the mechanism of the arm system, so that correct positioning of the arm system may be compromised.

CAUTION Risk of equipment damage caused by overheating! Never cover parts or the entire light head while using the Sola 300. CAUTION Danger of personal injury and equipment damage! Do not rest on the spring arm!

Sola 300

016

A

 Switch the Sola 300 on or off, using the switch (A) on the cardan joint.

Instructions for use Sola 300

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Operation

Sola 300 Mobile

016

A

 Switch the Sola 300 Mobile on or off, using the switch (A) on the cardan joint. CAUTION Danger of personal injury and equipment damage! Do not stand on the trolley.

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Instructions for use Sola 300

Service Work

Service Work Service work may only be carried out by experts.

Replacing bulbs Replacing bulbs

WARNING Danger of personal injury and/or equipment damage!

A

Disconnect the Sola 300 from the power supply before replacing the bulb. CAUTION Risk of burns!

017

019

Allow the Sola 300 to cool down.

1

The "Warning: hot surface!" warning plate is located in the opening of the reflector.

Remove the cover (A) on the upper surface of the light head.

B

020

018

C

2

Instructions for use Sola 300

Push the fixing clamp (B) forward with your finger and simultaneously turn it counterclockwise until the bulb (C) can be removed.

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Service Work

A

021

B

1

Hold the bulb socket (A) on the edge and pull it out of the reflector opening until both flat plugs are accessible.

2

Disconnect both flat plugs (B) from the connection cable.

CAUTION Risk of personal injury and/or equipment malfunction! Check the connection cable for scorch marks. Call DrägerService if scorch marks are found.

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Instructions for use Sola 300