Instructions for Use
102 Pages
Preview
Page 1
Instructions for Use
Polaris 7XX/5XX
WARNING To properly use this medical device, the user must obtain a full understanding of the performance characteristics of this medical device prior to use by carefully reading these Instructions for Use.
Operating light/Video system
Typographical Conventions 1
Consecutive numbers indicate steps of action, with the numbering restarting with "1" for each new sequence of actions.
z 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.
Trademarks –
DrägerService®
–
Polaris™
are trademarks owned by Dräger.
2
Instructions for Use Polaris 7XX/5XX
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 difficulties when operating the device.
Abbreviations and Symbols For explanations, refer to sections "Abbreviations" and "Symbols" in the "Overview" chapter.
Instructions for Use Polaris 7XX/5XX
3
This page intentionally left blank
4
Instructions for Use Polaris 7XX/5XX
Table of Contents
Table of Contents For Your Safety and that of Your Patients . .
7
General Safety Information... 7 Product-specific safety information... 10
Safety information for reprocessing... 69 Reprocessing... 70 Reprocessing procedure... 72
Application... 13
Troubleshooting...
77
Intended use Polaris 7XX/5XX... 13 Intended use Polaris camera SD... 14 Intended use Polaris camera HD... 15 Description... 16
Fault – Cause – Remedy...
77
Maintenance...
79
Polaris 7XX/5XX... Polaris camera SD/HD... Adjusting the arm system...
79 80 81
Disposal...
85
Disposal of the medical device...
85
Acceptance and Handover...
87
Overview... 17 Compatibility of the Polaris camera SD/HD components... 21 Assembly and Preparation... 27 Polaris 7XX/5XX... 27 Checking the Polaris camera SD/HD (optional)... 29 Mounting the Polaris camera SD (optional)... 30 Mounting the Polaris camera HD (optional)... 35 Video control unit connections... 40 Mounting the video control unit (optional)... 42 Flatscreen... 45 Operation... 47 Positioning the Polaris 7XX/5XX... 47 Positioning the light system... 48 Positioning Polaris 7XX/5XX with camera SD/HD... 52 Switching the Polaris 7XX/5XX OR light mode on and off... 53 Adjusting the illumination intensity of the Polaris 7XX/5XX... 55 Switching the Polaris 7XX/5XX ambient light mode on and off... 56 Adjusting the light field diameter... 58 Operating the Polaris camera SD... 59 Operating the Polaris camera HD... 63 Camera SD/HD remote control... 67
Polaris 7XX/5XX/Polaris camera SD/HD... 87 Camera SD/HD remote control... 87 Technical Data...
89
EMC declaration... 89 Ambient conditions... 93 Polaris 7XX/5XX... 94 Polaris camera SD... 98 Polaris camera HD... 99 Classification... 100 List of Accessories... 101 Polaris 7XX/5XX... 101 Polaris camera SD... 101 Polaris camera HD... 101
Cleaning, Disinfection and Sterilization... 69 Instructions for Use Polaris 7XX/5XX
5
This page intentionally left blank
6
Instructions for Use Polaris 7XX/5XX
For Your Safety and that of Your Patients
For Your Safety and that of Your Patients
General Safety Information The following WARNING and CAUTION statements apply to the general operation of the medical device. 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. Strictly follow these Instructions for Use WARNING Any use of the medical device requires full understanding and strict observation of all sections of these Instructions for Use. The medical device may only be used for the purpose specified under "Intended 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 7XX/5XX
Maintenance WARNING The medical device must be inspected and serviced regularly by trained personnel. Repair and complex maintenance works on the medical device have to be carried out by experts. Dräger recommends the DrägerService for concluding a service contract as well as for repairs. Dräger recommends using original Dräger parts for repairs. If the above are not complied with, the correct functioning of the medical device may be compromised. Observe chapter "Maintenance". Safety inspections The medical device must be subject to regular safety inspections. See chapter "Maintenance".
7
For Your Safety and that of Your Patients
Accessories WARNING Only accessories indicated on the list of accessories have been tested and approved to be used with the medical device.
Safe connection with other electrical equipment OR servers have to be classified according to software class B (following IEC 62304). WARNING OR servers may damage the light system.
Therefore, it is strongly recommended that only these accessories are used in conjunction with the medical device. Otherwise, the correct functioning of the medical device may be compromised.
If the OR servers do not comply with IEC 60601-1 for use in the patient environment, patients may be in danger when the light system fails.
Connected devices
Ensure that the OR servers comply with IEC 60601-1 for use in the patient environment.
WARNING Risk of electric shock and of device malfunction. Any connected devices or device combinations not complying with the requirements mentioned in these Instructions for Use may compromise the correct functioning of the medical device. Before operating any combination of devices, refer to and strictly comply with the Instructions for Use for all connected devices and device combinations. Not for use in areas of explosion hazard WARNING This medical device is neither approved nor certified for use in areas where combustible or explosive gas mixtures are likely to occur. The medical device is neither approved nor certified for use in areas where combustible gas mixtures of anesthetic agent and air, oxygen or N2O (laughing gas) are present.
WARNING Danger of personal injury The flatscreens used must be classified according to IEC 60601-1 for use within the patient environment. 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. 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 and WARNING and CAUTION statements are therefore largely limited to the specifics of the Dräger medical device. These Instructions for Use do not contain references to various hazards which are obvious to a medical professional who operates this medical device as well as references to the consequences of medical device misuse and to potentially adverse effects in patients with different underlying diseases.
8
Instructions for Use Polaris 7XX/5XX
For Your Safety and that of Your Patients
Medical device modification or misuse can be dangerous. Functional safety The essential performance characteristics of this medical device are illumination of the operating field and reduction of heat radiation to the operating field. Information on Electromagnetic Compatibility WARNING General information on electromagnetic compatibility (EMC) according to international EMC standard IEC 60601-1-2: Medical electrical equipment is subject to special precautionary measures concerning electromagnetic compatibility (EMC) and must be installed and put into operation in accordance with the EMC information provided on page 89. Portable and mobile RF communications equipment can affect medical electrical equipment. Installing accessories CAUTION 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 system. Strictly observe Assembly Instructions and Instructions for Use. Training Training for medical professionals is available from the Dräger organization responsible, see www.draeger.com.
Instructions for Use Polaris 7XX/5XX
9
For Your Safety and that of Your Patients
Product-specific safety information Do not use non-sterile handles
Improper applications
WARNING Risk of infection for patients.
WARNING Danger of personal injury and/or equipment damage.
Do not use non-sterile handles on the lights. Do not use disposable sleeves WARNING Risk of infection if disposable sleeves are dropped! Dräger recommends not using disposable sleeves for the lights. Do not use non-sterile handles on the lights. Maximum heat intensity within the light fields WARNING Danger of personal injury. Heat radiation may exceed 1000 W/m2
if the light fields of two or more lights are focused on one spot. Using extreme caution when working with the light system WARNING Danger of personal injury and/or equipment damage. Avoid collision of the light heads or parts of the arm system. These objects can fall down into the operation field.
10
Do not hang any objects on the light head or on the arm system. These objects can fall down into the operation field. Do not hang heavy loads on the arm system (e.g., hanging body weight). Damage may result to the mechanism of the arm system so that correct positioning of the swivel arm may be compromised. Risk of an electric shock WARNING Risk of an electric shock. When installing the light, 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. WARNING Risk of an electric shock. Do not simultaneously touch the sterilizable handle of the camera SD or camera HD and the patient. WARNING Risk of an electric shock. Do not touch the video control unit and the patient at the same time.
Instructions for Use Polaris 7XX/5XX
For Your Safety and that of Your Patients
Danger of excessive light radiation WARNING Danger of personal injury. Do not position the light such that the light field is directed towards the unprotected eye of the patient. Pay attention to the end stops CAUTION Danger of personal injury and/or equipment damage. When positioning the lights, do not use force to pull the arm system beyond the end stops. Risk of overheating the light head CAUTION Risk of equipment damage caused by overheating. Do not cover parts or the entire light head while using it. Direct visibility of the operation field WARNING The Polaris camera SD/HD is not intended to be used as the sole visualization medium during the operation. It must be ensured that the OR personnel have a direct view of the operation field at all times.
Instructions for Use Polaris 7XX/5XX
11
This page intentionally left blank
12
Instructions for Use Polaris 7XX/5XX
Application
Application
Intended use Polaris 7XX/5XX The Polaris product line
Double or triple light combination
Polaris lights are classified as operating lights in accordance with IEC 60601-2-41 and are intended to be used for the local illumination of the surgery and treatment area on the patient in operating and treatment rooms.
Combining large operating lights as an operating light system enables their use in operating and treatment rooms.
Versions –
Polaris 700 light
–
Polaris 750 light (prepared for integrating the Polaris camera SD)
–
Polaris 760 light (prepared for integrating the Polaris camera HD)
–
Polaris 500 light
–
Polaris 550 light (prepared for integrating the Polaris camera SD)
–
Polaris 560 light (prepared for integrating the Polaris camera HD)
–
Polaris camera SD
–
Polaris camera HD
Single light As a single light, the Polaris light is intended to be used as an operating or examination light in operating or treatment rooms for diagnosis and treatment purposes which can be interrupted without posing a hazard to the patient in case the light fails to work. If used as a single light, the Polaris light is classified as "small operating light" in accordance with IEC 60601-2-41. The Polaris 700/750/760 light and Polaris 500/550/560 light differ with regard to the size of the light head diameter and illumination intensity: Polaris 700/750/760 Light head diameter
785 mm
Illumination intensity
Approx. 160000 lux
Polaris 500/550/560
Instructions for Use Polaris 7XX/5XX
Light head diameter
630 mm
Illumination intensity
Approx. 110000 lux
13
Application
Intended use Polaris camera SD For recording the operation procedure in the OR field for patient documentation purposes in teaching and training. For use as a video system in conjunction with a medically approved flatscreen on the Polaris arm system. The recordings may only be used for non-diagnostic evaluations. The Polaris camera SD may only be used in conjunction with the Polaris light.
14
Instructions for Use Polaris 7XX/5XX
Application
Intended use Polaris camera HD For recording the operation procedure in the OR field for patient documentation purposes in teaching and training. For use as a video system in conjunction with a medically approved flatscreen on the Dräger arm system. The Polaris camera HD may only be used in conjunction with the Polaris light. The recordings may only be used for non-diagnostic evaluations. A Polaris camera HD system consists of: –
Polaris camera HD which creates images with a resolution of 1920 x 1080 pixels
–
Video control unit to control the Polaris camera HD.
Instructions for Use Polaris 7XX/5XX
15
Application
Description
Polaris 7XX/5XX
Polaris camera SD
The Polaris light is designed for use in demanding applications and is certified and approved to be used as an operating light.
The Polaris camera SD is used for recording the operation procedure in the operation field for documentation purposes in teaching and training. It must not be used for diagnostic purposes.
Modern LED bulbs are used in the Polaris light. This ensures low energy consumption and a long service life of the bulb. The small size of the LEDs made it possible to use a modern design which facilitates handling and cleaning while also maintaining good flow behavior under laminar flow ceilings. The Polaris 700/750/760 light combines the illumination intensity of 108 white LEDs and the Polaris 500/550/560 light the illumination intensity of 60 white LEDs to form a homogeneous illumination volume of considerable illumination depth and low shadiness. A color temperature similar to natural light, good color reproduction, and dimmable illumination intensity with a focusable light field diameter ensure working conditions for demanding surgical and treatment procedures. –
The Polaris light is available with the Polaris camera SD option for the visualization of the surgical procedure and treatment area.
–
The Polaris light is available with a medically approved flatscreen option for the displaying of the images taken with the Polaris camera SD.
–
The Polaris light is available with the Polaris camera HD option for the visualization of the surgical procedure and treatment area.
–
The Polaris light is available with a medically approved flatscreen option for the displaying of the images taken with the Polaris camera HD.
16
–
Standard version: Connection to a flatscreen with S-video input (Y/C).
–
Available with a medically approved flatscreen option: The flatscreen is used to display the images recorded with the Polaris camera SD.
Polaris camera HD The Polaris camera HD is used for recording the operation procedure in the operation field for documentation purposes in teaching and training. It must not be used for diagnostic purposes. –
Standard version: Connection to a flatscreen with HD-SDI input.
–
Available with a medically approved flatscreen option: The flatscreen is used to display the images recorded with the Polaris camera HD.
Instructions for Use Polaris 7XX/5XX
Overview
Overview
Polaris 700/550 light system with Polaris camera SD (example of use)
A C E
D
B
E
D
F
F
K
K I
H
G
I
M
L
J
N O
J Q
R 001
P A Ceiling cover
K Circular handle
B IR receiver for camera SD remote control
L Polaris camera SD
C Ceiling tube
M Camera replacement handle
D Swivel arm/central axis
N Adapter ring
E Spring arm
O Sterilizable handle for Polaris camera SD
F Cardan mounting
P Sterilizable focus adjustment ring
G Polaris 700 light head
Q Wall-mounted control for Polaris 700/550 and Polaris camera SD
H Polaris 550 light head I
Light control panel
J
Sterilizable handle
Instructions for Use Polaris 7XX/5XX
R Camera SD remote control
17
Overview
Polaris 700/560 light system with Polaris camera HD (example of use)
A
D
E
C
D J
U
T
U
D
E
J
B
E
F
F
K
K I
H
G
I
M
L
J
N O
J
Q
P
R
002
S
A Ceiling cover
M Camera replacement handle
B IR receiver for camera HD remote control
N Adapter ring
C Ceiling tube
O Sterilizable handle for Polaris camera HD
D Swivel arm/central axis
P Sterilizable focus adjustment ring
E Spring arm
Q Wall-mounted control for Polaris 700/560
F Cardan mounting
R Camera HD remote control
G Polaris 700 light head
S Video control unit
H Polaris 560 light head
T Double flatscreen mount
I
Light control panel
U Flatscreen
J
Sterilizable handle
K Circular handle L Polaris camera HD
18
Instructions for Use Polaris 7XX/5XX
Overview
Polaris 700 light head
Polaris 550 light head with Polaris camera SD (optional)
A
C
A
C
B G
D
E
E
B D
F G 004
003
F A Cardan mounting B Light control panel
A Cardan mounting
C Circular handle
B Light control panel
D Bottom glass
C Circular handle
E Sterilizable handle
D Bottom glass
F Reflector
E Polaris camera SD
G LEDs (light-emitting diodes)
F Sterilizable handle for Polaris camera SD G Sterilizable focus adjustment ring
Instructions for Use Polaris 7XX/5XX
19
Overview
Polaris 560 light head with Polaris camera HD (optional)
A
C
E
B D
F
004
G A Cardan mounting B Light control panel C Circular handle D Bottom glass E Polaris camera HD F Sterilizable handle for Polaris camera HD G Sterilizable focus adjustment ring
20
Instructions for Use Polaris 7XX/5XX