Polaris 100 and 200 Surgical lights Instructions for Use Aug 2019

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Instructions for use Polaris 100/200SW X.n

Information on the instructions for use

Information on the instructions for use

Typographical conventions 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 related illustration. A Letters in illustrations denote elements referred to in the text. Bold, italicized text indicates labels on the device.

Regional availability Some components may not be available in every country. Please contact your local contact person for further information.

The following web page lists the local contact persons: www.draeger.com

Trademarks Trademarks owned by Dräger Trademark Polaris® The following web page provides a list of the countries in which the trademarks are registered: www.draeger.com/trademarks Instructions for use Polaris 100/200 SW X.n

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Information on the instructions for use

Safety information definitions 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 medical device or other property. NOTE A NOTE provides additional information intended to avoid inconvenience during operation.

Target groups

Duties of the operating organization

Description of target groups

The tasks described in this document specify the requirements that have to be met by each respective target group.

The target groups may only perform the following tasks if they meet the corresponding requirements.

The operating organization of this product must ensure the following:

Users

–

The target group has the required qualifications (e.g., has undergone specialist training or acquired specialist knowledge through experience).

–

The target group has been trained to perform the task.

–

The target group has read and understood the chapters required to perform the task.

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This target group includes healthcare professionals such as surgeons and OR nurses. Task

Requirement

Use of the product in Training in a relevant accordance with the healthcare field or in a intended use medical discipline and knowledge of the use of the product

Instructions for use Polaris 100/200

Information on the instructions for use

Reprocessing personnel

Specialized service personnel

This target group includes persons who are responsible for the reprocessing of medical devices.

Task

Requirement

Installation

Specialist knowledge in electrical engineering and mechanics

Task

Requirement

Reprocessing

Specialist knowledge in the reprocessing of medical devices

Service personnel Task

Requirement

Basic and complex service activities (inspection, maintenance, repair)

Experience in the servicing of medical devices Training in service activities on this product

Dräger recommends arranging a service contract with DrägerService.

Installation

Specialist knowledge in Basic service activi- electrical engineering and mechanics ties (inspection, maintenance acExperience in the servicing cording to the "Main- of medical devices tenance" chapter)

Abbreviations and symbols Explanations can be found in the sections "Abbreviations" and "Symbols" sections in chapter "Overview".

Instructions for use Polaris 100/200 SW X.n

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Instructions for use Polaris 100/200

Contents

Contents Information on the instructions for use...

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Maintenance...

Typographical conventions... Regional availability... Trademarks... Safety information definitions... Target groups...

3 3 3 4 4

Safety-related information...

9

Overview... 67 Definition of terms for maintenance... 67 Inspection... 69 Adjusting the arm system... 72 Preventive maintenance... 75 Repair... 77

General safety information... 9 Product-specific safety information... 14 Application... 17

Disposal...

67

79

Disposing of the medical device... 79 Disposing of non-rechargeable batteries... 79 Disposal of accessories... 80

Intended use... 17 Environments of use... 18 Description... 19

Acceptance and handover...

81

Polaris 100/200...

81

Overview... 21

Technical data...

83

Assembly and preparation... 29

EMC declaration... Polaris 100/200...

83 85

List of accessories...

91

Index...

93

Checking for operational readiness before each use... 29 Operation... 37 Positioning a light... 37 Positioning a light system... 40 Light system status indicator... 43 Switching the OR light mode on and off... 45 Setting the illuminance... 47 Switching the ambient light mode (Endo light) on and off... 48 Reprocessing... 51 Safety information... 51 Disassembly... 52 Service life of the handle... 55 Overview of reprocessing procedures... 56 Assembling the parts... 60 Troubleshooting... 61 Fault – Cause – Remedy... 61

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Instructions for use Polaris 100/200 SW X.n

Safety-related information

Safety-related information

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

Strictly follow the instructions for use of other Dräger devices

WARNING and CAUTION statements specific to subsystems or particular features of the medical device appear in the respective sections of these instructions for use or in the instructions for use of another product being used with this device.

WARNING Risk of incorrect operation and of incorrect use

Strictly follow these instructions for use

For correct use of a Polaris 600 light in combination with the Polaris 100 or 200 light, read and observe the Polaris 600 instructions for use.

WARNING Risk of incorrect operation and of incorrect use

WARNING Risk of incorrect operation and of incorrect use

Any use of the medical device requires full understanding and strict observation of all sections of these instructions for use. The medical device must only be used for the purpose specified under "Intended use".

For correct use of a display mount in combination with a Polaris light, read and observe the Polaris Multimedia instructions for use.

Strictly observe all WARNING and CAUTION statements throughout these instructions for use and all statements on medical device labels. Failure to observe these safety information statements constitutes a use of the medical device that is inconsistent with its intended use.

Instructions for use Polaris 100/200 SW X.n

Strictly follow the assembly instructions WARNING Risk of damage to the device The light system must only be installed by assembly personnel. The installation must be carried out in accordance with the assembly instructions.

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Safety-related information

Maintenance

Connected devices

WARNING Risk of medical device failure and of patient injury

WARNING Risk of electric shock and device malfunction

The medical device must be inspected and serviced regularly by service personnel. Repair and complex maintenance carried out on the medical device must be performed by specialized service personnel. If the above is not complied with, medical device failure and patient injury may occur. Observe chapter "Maintenance". Dräger recommends that a service contract is obtained with DrägerService and that all repairs are performed by DrägerService. Dräger further recommends that only authentic Dräger repair parts are used for maintenance.

Accessories WARNING Risk due to incompatible accessories

Any connected devices or device combinations not complying with the requirements mentioned in these instructions for use can compromise the correct functioning of the medical device and lead to an electric shock. Before operating the medical device, strictly comply with the instructions for use of all connected devices or device combinations.

Safe connection with other electrical equipment CAUTION Risk of patient injury Electrical connections to equipment not listed in these instructions for use or these assembly instructions must only be made when approved by each respective manufacturer.

The use of incompatible accessories may adversely affect the functional integrity of the product. Personal injury and property damage may occur as a consequence. Use only compatible accessories. The accessories that are compatible with this product are listed in the list of accessories supplied with the product.

Not for use in areas of explosion hazard WARNING Risk of fire The medical device is not approved for use in areas where combustible or explosive gas mixtures are likely to occur.

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Instructions for use Polaris 100/200 SW X.n

Safety-related information

Device combinations

Patient safety

This device can be operated in combination with other Dräger devices or with devices from thirdparty manufacturers. Follow the accompanying documents of the individual devices.

The design of the medical device, the accompanying documentation, and the labeling on the medical device are based on the assumption that the purchase and the use of the medical device are restricted to persons familiar with the most important inherent characteristics of the medical device.

If a device combination is not approved by Dräger, the safety and the functional integrity of the individual devices may be compromised. The operating organization must ensure that the device combination complies with the applicable editions of the relevant standards for medical devices.

Instructions and WARNING and CAUTION statements are therefore largely limited to the specifics of the Dräger medical device.

Device combinations approved by Dräger meet the requirements of the following standards:

The instructions for use do not contain any information on the following points:

–

–

Risks that are obvious to users

–

Consequences of obvious improper use of the medical device

–

Potentially negative effects on patients with different underlying diseases

IEC 60601-1, 3rd edition (general safety requirements, device combinations, softwarecontrolled functions) –

IEC 60601-1-2 (electromagnetic compatibility)

Or: –

IEC 60601-1, 2nd edition (general requirements for safety) –

IEC 60601-1-1 (device combinations)

–

IEC 60601-1-2 (electromagnetic compatibility)

–

IEC 60601-1-4 (software-controlled functions)

Instructions for use Polaris 100/200 SW X.n

Medical device modification or misuse can be dangerous.

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Safety-related information

Electromagnetic compatibility (EMC) Medical electrical equipment is subject to special precautionary measures concerning electromagnetic compatibility. During installation and before initial operation, follow the information in section: "EMC declaration" (page 83). This device can be affected by other electrical devices. WARNING Risk due to electrostatic discharge Malfunctions that endanger the patient may occur if no protective measures against electrostatic discharge are employed in the following situations: – When touching the pins of connectors that carry the ESD warning symbol. – When establishing connections with these connectors. To prevent malfunctions, observe the following measures and train the relevant personnel: – Observe the ESD protective measures. Such measures may include wearing antistatic clothing and shoes, touching a potential equalization pin before and while making the connection, or using electrically insulating and antistatic gloves. – Observe the requirements for the electromagnetic environment. Observe the following section: "Electromagnetic environment" (page 83).

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WARNING Risk due to electromagnetic disturbance Wireless communication devices (e.g., cellular phones) and medical electrical equipment (e.g., defibrillators, electrosurgical devices) emit electromagnetic radiation. When such devices are operated too close to this device or its cables, the functional integrity of this device may be compromised by electromagnetic disturbances. As a result, the patient could be put at risk. Maintain a distance of at least 0.3 m (1.0 ft) between this device and wireless communication devices, to ensure that the essential performance of this device is fulfilled. Maintain an adequate distance between this device and other medical electrical equipment.

Installing accessories CAUTION Risk of device failure Install accessories to the basic device in accordance with the instructions for use of the basic device. Make sure that there is a safe connection to the basic device. Strictly observe instructions for use and assembly instructions.

Instructions for use Polaris 100/200 SW X.n

Safety-related information

Storing the instructions for use CAUTION Risk of incorrect use Instructions for use must be kept accessible to the user.

Training Training for users is available via the Dräger organization responsible (see www.draeger.com).

Functional safety The essential performance of lights consists in: –

illumination of the operating field,

–

reduction of thermal radiation into the operating field.

Obligation to report incidents Serious incidents involving this medical device must be reported to Dräger and the competent authorities.

Instructions for use Polaris 100/200 SW X.n

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Safety-related information

Product-specific safety information

Do not use non-sterile handles WARNING Risk of infection Personnel and patient may become infected by a non-sterile handle. Use only sterile handles.

Exercise caution when working with the system WARNING Risk of personal injury and property damage Objects can fall down into the operating field. Avoid collision of the light heads or of parts of the arm system.

Use of disposable sleeves Incorrect use WARNING Risk of infection Disposable sleeves can fall down into the operating field. Dräger recommends using disposable sleeves from another manufacturer (e.g., Covidien) only with the corresponding handle adapter for disposable sleeves from the same manufacturer, see list of accessories.

Thermal radiation from the lights

WARNING Risk of personal injury and property damage Do not place objects on the swivel arms and their devices or hang them on the arm system. These objects can fall down into the operating field. Do not hang heavy loads on the arm system (e.g., leaning body weight). The mechanism of the arm system may be damaged, which may compromise the correct positioning of the arm system.

WARNING Risk of personal injury

Risk of electric shock

Heat radiation intensity may exceed 1000 W/m2 if the light fields of two or more lights are focused on one spot.

WARNING Risk of electric shock Persons may receive an electric shock if all poles are not disconnected during maintenance work. Make sure that a switching element to disconnect all poles of the supply is fitted before installing the light. The required switching element is part of the Dräger mains connection component.

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Instructions for use Polaris 100/200 SW X.n

Safety-related information

Direct view of the operating field

Cautious positioning of the arm system

WARNING Risk of personal injury

CAUTION Risk of personal injury and property damage

A camera is not intended to be used as the sole visualization medium during an operation.

The stops on the arm system may become damaged.

Make sure that the OR personnel have a direct view of the operating field at all times.

When positioning the swivel arms and the attached devices, take care not to use force to pull the arm system beyond the stops.

Lines on the display

Risk of the light head overheating

NOTE Lines may appear on the display if a different manufacturer's camera (i.e., not the Dräger MedView camera) is used in combination with the Polaris 100/200 light. In this case, adjust the camera's shutter frequency.

CAUTION Risk of property damage

Do not use Polaris 100/200 Mobile near magnetic resonance imagers WARNING Risk of device malfunction and of personal injury Magnetic fields can affect the correct functioning of the medical device and thus endanger the patient or user. Do not use the medical device near magnetic resonance imagers (MRI, NMR, NMI).

The light head may overheat during operation. Do not cover the light head completely or partially.

Compatibility of displays WARNING Risk due to incompatible displays The displays used in combination with a Polaris light system must be approved for use in the patient environment according to IEC 60601-1.

Observe the maximum load of the display mount WARNING Risk of personal injury and property damage The specification for the maximum load on the display mount must not be exceeded. Comply with the maximum load of the display mount.

Instructions for use Polaris 100/200 SW X.n

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Safety-related information

Read and observe the instructions for use of the displays WARNING Risk of device malfunction To properly use the light system, read and comply with the instructions for use of the respective display.

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Instructions for use Polaris 100/200 SW X.n

Application

Application

Intended use

Intended use of the Polaris 100/200 light

Ceiling-mounted versions –

Polaris 100 light

Polaris product family

–

Polaris 200 light

Polaris 100 and Polaris 200 lights are classified as surgical lights in accordance with IEC 60601-2-41 and are intended to be used for the local illumination of the operating field and examination field on the patient in operating and treatment rooms.

Double or triple light combination

Polaris 100 and Polaris 200 lights differ with regard to the number of LED bulbs and the illuminance:

As a single light, the Polaris 100 or Polaris 200 light is intended to be used as a surgical or examination light in operating and treatment rooms for diagnostic and treatment purposes which can be interrupted without posing a hazard to the patient in case the light fails.

Polaris 100 Number of LED bulbs

48

Number of LED stripes

8

Central illuminance

120000 lx

Central color temperature

4400 K, 5000 K, or 5600 K

Polaris 200 Number of LED bulbs

66

Number of LED stripes

11

Central illuminance

160000 lx

Central color temperature

4400 K, 5000 K, or 5600 K

Combining large surgical lights as a surgical light system enables their use in operating and treatment rooms. Single light

As a single light, the Polaris 100 or Polaris 200 light is classified as a "small surgical light" in accordance with IEC 60601-2-41. Mobile versions –

Polaris 100 Mobile light

–

Polaris 200 Mobile light

Additional light As an addition to an existing surgical light system in the operating room, with battery to bridge a mains power supply failure. Single light As a single light, the Polaris 100 Mobile or Polaris 200 Mobile light is intended to be used as a surgical light or examination light in operating and treatment

Instructions for use Polaris 100/200 SW X.n

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Application

rooms for diagnostic and treatment purposes which can be interrupted without posing a hazard to the patient in case the light fails.

Intended use of the Dräger disposable handle

As a single light, the Polaris 100 Mobile or Polaris 200 Mobile light is classified as a "small surgical light" in accordance with IEC 60601-2-41.

The Dräger disposable handle provides a sterile cover for the associated inner handle of Polaris systems. The Dräger disposable handle is intended solely for single use.

Environments of use Polaris 100 and Polaris 200 lights are intended for use in rooms used for medical purposes, especially operating rooms and treatment rooms.

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Instructions for use Polaris 100/200 SW X.n

Application

Description Polaris 100 and Polaris 200 lights are certified and approved as surgical lights. Polaris 100 and Polaris 200 lights use LED bulbs. This ensures low energy consumption and a long service life of the bulb. The small size of the LED bulbs makes it possible to use a design which facilitates ease of handling and cleaning while also maintaining good flow behavior under laminar flow ceilings.

OR light mode The Polaris 100 light combines the illuminance of 48 white LED bulbs, the Polaris 200 light combines the illuminance of 66 white LED bulbs to create a homogeneous light cylinder with deep cavity illumination and shadow dilution. A color temperature similar to that of daylight, good color reproduction, and dimmable illuminance ensure optimum working conditions for demanding procedures within the operating field and the examination field. The illuminance can be customized in the OR light mode.

Ambient light mode (Endo light) In the ambient light mode, the surroundings can be illuminated for minimally invasive procedures. In this light mode, the illuminance is significantly lower and therefore does not meet the requirements of the OR light mode. The illuminance cannot be customized in the ambient light mode.

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Instructions for use Polaris 100/200 SW X.n