Instructions for Use
96 Pages
Preview
Page 1
Instructions for use
Polaris 600
WARNING To properly use this medical device, read and comply with these instructions for use.
Surgical light Polaris 600
This page has been left blank intentionally.
2
Instructions for use Polaris 600
Contents
Contents Polaris 600
Information regarding the instructions for use ...
5
Regional availability... Trademarks ... Safety information definitions ... Target group ... Abbreviations and symbols...
5 5 6 6 7
Safety-related information ...
8
General safety information ... 8 Product-specific safety information... 12 Application ... 15 Intended use... 15 Environments of use... 16 Description... 16 Overview... 17 Multimedia system with 2 Polaris 600 lights (configuration example) ... Light system with a Polaris 600 and a Polaris 100 light (configuration example) ... Polaris 600 light with sterilizable handle E ... Polaris 600 light with sterilizable handle E and MedView camera... Light control panel ... MedView camera (option)... Wall-mounted control panel for 2 Polaris 600 lights and a MedView camera (configuration example)... OR panel (option) ... Polaris 600 control interface (option)... Abbreviations... Symbols...
17 19 20 20 21 22 23 24 24 24 25
Assembly and preparation... 31 Checking for operational readiness before each use... Fitting the handle...
31 32
Operation ... 35 Positioning a light ... Positioning a light system... Positioning the MedView camera ... Status LEDs ... Switching the light on and off ... Synchronization function ... Setting the illuminance ... Color temperature function... Light field diameter function ... Ambient light mode (Endo light) ... Operating the MedView camera using the wallmounted control panel... Operating the MedView camera by means of the Polaris 600 remote control for MedView camera ... Replacing the battery in the Polaris 600 remote control for MedView camera...
35 37 38 39 40 40 42 48 49 51 52 57 58
Troubleshooting... 60 Fault – Cause – Remedy...
60
Reprocessing ... 66 Safety information ... Disassembly ... Service life of the handle ... Overview of reprocessing procedures... Materials used in the light... Assembling the parts...
66 67 69 70 72 72
Operating concept ... 26
Maintenance ... 73
Operating controls and their functions on the Polaris 600 light ... Operating controls and their functions on the Polaris 600 and Polaris 100/200 light system.. Sterilizable handle E... Wall-mounted control panel (option)... Color assignment of the lights to the wallmounted control panel ...
Overview ... Inspection ... Preventive maintenance... Repair... Adjusting the arm system ... Locking segment of the spring arm ... Acceptance and handover...
Instructions for use Polaris 600
26 27 28 29 30
73 73 76 76 77 79 80
3
Contents
Disposal... 81 Disposing of the medical device... Disposing of non-rechargeable batteries... Disposal of accessories...
81 81 81
Technical data... 82 EMC declaration... 82 Ambient conditions ... 84 Technical light data ... 84 Electrical data... 86 Mechanical data ... 87 MedView camera... 87 Polaris 600 remote control for MedView camera ... 88 Wireless video transmission ... 88 Combination with system components ... 90 Operating options ... 90 Classifications ... 90 List of accessories ... 92 List of accessories for Polaris light and MedView camera...
92
Index ... 93
4
Instructions for use Polaris 600
Information regarding the instructions for use
Information regarding the instructions for use 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 600
5
Information regarding the instructions for use
Safety information definitions WARNING
CAUTION
A WARNING statement provides important information about a potentially hazardous situation which, if not avoided, could result in death or serious injury.
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 group Duties of the operating organization
Users
The tasks described in this document specify the requirements that have to be met by each respective target group.
This target group includes healthcare professionals such as surgeons and OR nurses.
The operating organization of this product must ensure the following: –
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.
Description of target groups The target groups may only perform the following tasks if they meet the corresponding requirements.
6
Task
Requirement
Use of the product in Training in a relevant accordance with its healthcare field or in a intended use medical discipline and knowledge of the use of the product
Reprocessing personnel This target group includes persons who are responsible for the reprocessing of medical devices. Task
Requirement
Reprocessing
Specialist knowledge in the reprocessing of medical devices
Instructions for use Polaris 600
Information regarding the instructions for use
Service personnel
Specialized service personnel
Task
Task
Requirement
Installation
Specialist knowledge in electrical engineering and mechanics Experience in the servicing of medical devices Training in service activities on this product
Requirement
Installation
Specialist knowledge in electrical engineering and Basic service activimechanics ties (inspection, Experience in the servicing maintenance accordof medical devices ing to the "Maintenance" section)
Basic and complex service activities (inspection, maintenance, repair)
Dräger recommends arranging a service contract with DrägerService.
Abbreviations and symbols Explanations can be found in the sections "Abbreviations" and "Symbols" in chapter "Overview".
Instructions for use Polaris 600
7
Safety-related information
Safety-related information General safety information The following WARNING and CAUTION statements apply to general operation of the medical device. 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.
Strictly follow these instructions for 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" (see page 15). 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.
8
Strictly follow the instructions for use of other Dräger devices WARNING Risk of incorrect operation and of incorrect use For correct use of a Polaris 100 or 200 light in combination with the Polaris 600 light, read and observe the Polaris 100/200 instructions for use. WARNING Risk of incorrect operation and of incorrect use For correct use of a display mount in combination with a Polaris light, read and observe the Polaris Multimedia instructions for use.
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.
Instructions for use Polaris 600
Safety-related information
Service
Connected devices
WARNING
WARNING
Risk if service is not performed regularly
Risk of electric shock and of device malfunction
If service is not performed regularly, malfunctions may occur, which can result in personal injury and property damage. Perform the service in accordance with the chapter "Maintenance".
Accessories
Any connected devices or device combinations not complying with the requirements in these instructions for use may compromise the correct functioning of the medical device. Before using the medical device, refer to and strictly comply with the instructions for use of all connected devices and device combinations.
WARNING Risk due to incompatible accessories
Safe coupling with electrical equipment
The use of incompatible accessories may adversely affect the functional integrity of the product. Personal injury and property damage may occur as a consequence.
CAUTION
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.
Risk of patient injury Coupling with electrical equipment that is not mentioned in these instructions for use or assembly instructions may only be done with the respective device manufacturer.
Device combinations This device may be operated in combination with other Dräger devices or with devices from thirdparty manufacturers. Observe the accompanying documents of the individual devices. If a device combination is not approved by Dräger, the safety and functional integrity of the individual devices may be compromised. The operator must ensure that the device combination conforms to the applicable editions of the relevant standards for medical devices. Device combinations that are approved by Dräger meet the requirements of the following standards: –
Instructions for use Polaris 600
IEC 60601-1, 3rd edition (general safety requirements, device combinations, softwarecontrolled functions) – IEC 60601-1-2 (electromagnetic compatibility) 9
Safety-related information
Or: –
IEC 60601-1, 2nd edition (general safety requirements) – IEC 60601-1-1 (device combinations) – IEC 60601-1-2 (electromagnetic compatibility) – IEC 60601-1-4 (software-controlled functions)
Patient safety 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. Instructions and WARNING and CAUTION statements are therefore largely limited to the specifics of the Dräger medical device. 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
Medical device modification or misuse can be dangerous.
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 82). This device can be affected by other electrical devices.
10
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 82).
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.
Instructions for use Polaris 600
Safety-related information
Radio-frequency interference
–
reduction of thermal radiation into the operating field.
WARNING Risk of device malfunction The light system can cause radio-frequency interference. Shielding of components or reorientation of the light system may be necessary.
Obligation to report incidents Serious incidents involving this medical device must be reported to Dräger and the competent authorities.
Installing accessories CAUTION Risk of device failure Install the accessory on the basic device in accordance with the instructions of the basic device. Check for secure connection to the basic device. Strictly observe the instructions for use and assembly instructions.
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,
Instructions for use Polaris 600
11
Safety-related information
Product-specific safety information Do not use non-sterile handles
Exercise caution when working with the system
WARNING Risk of infection
WARNING
Personnel and patient may become infected by a non-sterile handle.
Risk of personal injury and property damage
Use only sterile handles.
Avoid collisions of the light heads or of parts of the arm system with other objects.
Objects can fall down into the operating field.
Use of disposable sleeves Incorrect use WARNING Risk of infection
WARNING
Disposable sleeves can fall down into the operating field.
Risk of personal injury and property damage
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.
Do not place objects on the light heads 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.
Thermal radiation from the lights WARNING Risk of patient injury If the light fields from several lights overlap, the heat input to the wound site may be unacceptably high. This can lead to drying out of the wound site. If necessary, the total irradiance must be adjusted by reducing the illuminance of individual lights, see "Setting the illuminance" on page 42.
12
Risk of electric shock 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.
Instructions for use Polaris 600
Safety-related information
Direct view of the operating field
Observe the maximum load of the display mount
WARNING Risk of personal injury
WARNING
A camera is not intended to be used as the sole visualization medium during an operation.
Risk of personal injury and property damage
Make sure that the OR personnel have a direct view of the operating field at all times.
Comply with the maximum load of the display mount.
Cautious positioning of the arm system
Read and observe the instructions for use of the displays
The specification for the maximum load on the display mount must not be exceeded.
CAUTION Risk of personal injury and property damage
WARNING
The stops on the arm system may become damaged.
Risk of device malfunction
When positioning the swivel arms and the attached devices, take care not to use force to pull the arm system beyond the stops.
Risk of the light head overheating
To properly use the light system, read and comply with the instructions for use of the respective display.
OR server WARNING
WARNING Risk of property damage The light head may overheat during operation. Do not cover the light head completely or partially.
Compatibility of displays
Risk of patient injury The OR servers used must conform to Safety Class B of the IEC 62304 standard. WARNING Risk of patient injury The OR severs used must conform to the IEC 60601-1:1988 (or later) or IEC 60950-1 standards.
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.
Instructions for use Polaris 600
13
Safety-related information
Emission of high-frequency energy This medical device is optionally equipped with a radio transmitter. This medical device has been designed and manufactured to comply, amongst others, with emission limit values for high-frequency energy. These limit values are incorporated in international safety standards such as IEC 60601-1-2 and in radio equipment standards such as EN 301 893 which have been accepted by regulation authorities. The radio transmitter module of this device also complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: 1
this device may not cause harmful interference, and
2
this device must accept any interference received, including interference that may cause undesired operation of the device.
Changes or modifications not expressly approved by Dräger could void the user’s authority to operate the equipment. This medical device includes radio equipment in compliance with Directive 2014/53/EU. The full text of the EU declaration of conformity is available at the following internet address: www.draeger.com/doc-radio
14
Instructions for use Polaris 600
Application
Application Intended use Intended use of Polaris 600 light Polaris product family
Ceiling-mounted versions
The Polaris 600 light system is classified as a surgical light system in accordance with IEC 60601-2-41 and is intended to be used for the local illumination of the operating field and examination field on the patient in operating and treatment rooms.
Single light
The intended uses remain unchanged when the Polaris 600 light is combined with a Polaris 100 or 200 light.
As a single light, the Polaris 600 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 if the light fails. As a single light, the Polaris 600 light is classified as a "small surgical light" in accordance with IEC60601-2-41. Double or triple light combination The combination of 2 or more Polaris 600 lights as a surgical light system enables use in operating and treatment rooms and meets the requirements for a fail-safe surgical light system.
Intended use of the Dräger disposable handle 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.
Intended use of the MedView camera The MedView camera is intended for recording the operating field for the purpose of patient documentation, teaching, and training. In the Polaris 600 light system, the MedView camera is used together with a medical display as a video system. The MedView camera must only be used in conjunction with the Polaris 600 light. The recordings must only be used for nondiagnostic purposes.
Instructions for use Polaris 600
15
Application
Environments of use Polaris 600 lights are intended for use in rooms used for medical purposes, especially operating rooms and treatment rooms.
Description Light
Color temperature
The Polaris 600 light is certified and approved as a surgical light. The Polaris 600 light uses 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 modern design which facilitates ease of handling and cleaning while also maintaining good flow behavior under laminar flow ceilings.
The color temperature can be adjusted in 4 steps, which the surgeon can select depending on tissue structure, operating field, and individual perception. Cold white light increases concentration, while warm white light reduces dazzle effects and increases the contrast.
OR light mode The Polaris 600 light combines the illumination from 92 white LED bulbs to create a homogeneous light column with deep cavity illumination and minimal shadowing. The adjustable color temperature, good color reproduction, and adjustable illuminance ensure optimum working conditions for demanding procedures within the operating field and the examination field. The illuminance can be adjusted 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 than in the OR light mode. The illuminance cannot be adjusted in the ambient light mode.
16
Instructions for use Polaris 600
Overview
Overview
26588
Multimedia system with 2 Polaris 600 lights (configuration example)
A B F
C E
G M
E D
H
H
N
I
I
Q
J
Q
L K
J
P
O
O
R A Ceiling cover Instructions for use Polaris 600
S B IR receiver for Polaris 600 remote control for MedView camera 17
Overview
C Ceiling tube D Central axis E Light swivel arm F Display swivel arm G Display spring arm H Light spring arm I
Gimbal mounting
J
Light control panel
K Polaris 600 light L Polaris 600 light with MedView camera and radio transmitter M Display mount (24 inch to 32 inch) with radio receiver N Display O Sterilizable handle E P Sterilizable handle Q Integrated handle R Wall-mounted control panel S Polaris 600 remote control for MedView camera
18
Instructions for use Polaris 600
Overview
26890
Light system with a Polaris 600 and a Polaris 100 light (configuration example)
A D
B D C
E
E
F
F
K
K J
G I
G
H
H
L
A Ceiling cover
G Light control panel
B Ceiling tube
H Sterilizable handle
C Central axis
I
Polaris 600 light
D Light swivel arm
J
Polaris 100 light
E Light spring arm
K Integrated handle
F Gimbal mounting
L Wall-mounted control panel
Instructions for use Polaris 600
19
Overview
26592
Polaris 600 light with sterilizable handle E A Gimbal mounting B Integrated handle C Light control panel D Sterilizable handle E
A
E Lens with LED
B
F Bottom glass
A
C F
E
D
26591
Polaris 600 light with sterilizable handle E and MedView camera A Gimbal mounting B Integrated handle C Light control panel D Sterilizable handle E
A B
G
E Lens with LED F Bottom glass G MedView camera
A
C F
20
E
D
Instructions for use Polaris 600