PSL Portable Slit Lamp. User s Guide

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Transcription:

PSL Portable Slit Lamp User s Guide

2017 AMETEK, Inc. AMETEK is a registered trademark of AMETEK, Inc. Reichert and Reichert Technologies are registered trademarks of Reichert, Inc. The information contained in this document was accurate at time of publication. Specifications subject to change without notice. Reichert Technologies reserves the right to make changes in the product described in this manual without notice and without incorporating those changes in any products already sold. ISO 9001/13485 Certified Reichert products are designed and manufactured under quality processes meeting ISO 9001/13485 requirements. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, recording, or otherwise, without the prior written permission of Reichert Technologies. Caution: Federal law restricts this device to sale by or on the order of a licensed physician. Rx only.

Table of Contents Warnings & Cautions... 4 Symbol Information... 8 Introduction... 9 Indication for Use... 9 Contraindications... 9 Instrument Setup... 10 Unpacking Instructions... 10 Parts Identification...11 Battery Installation... 13 Eyepiece Check... 13 Operating Instructions... 14 Focusing and Adjusting Interpupilary Distance (IPD)... 14 Illumination Control... 15 Slit Width... 16 Selecting a Filter... 16 Forehead Support... 16 Magnification Change... 17 Cleaning & Maintenance... 18 Cleaning... 18 Storage... 18 Troubleshooting... 19 Chart of Common Errors... 19 Specifications... 20 Disposal... 21 Classifications... 21 Warranty... 22 15090-101 REV. F 3

Warnings & Cautions (continued) Reichert Technologies (Reichert) is not responsible for the safety and reliability of this instrument when: Assembly, disassembly, repair, or modification is made by unauthorized dealers or persons. Instrument is not used in accordance with this User s Guide. WARNING: AN INSTRUCTION THAT DRAWS ATTENTION TO RISK OF INJURY OR DEATH. WARNING: UNITED STATES FEDERAL LAW AND EUROPEAN REGULATIONS REQUIRE THAT THIS DEVICE BE PURCHASED ONLY BY A PHYSICIAN OR A PERSON ACTING ON BEHALF OF A PHYSICIAN. WARNING: THIS INSTRUMENT SHOULD BE USED IN STRICT ACCORDANCE WITH THE INSTRUCTIONS OUTLINED IN THIS USER S GUIDE. THE SAFETY OF THE OPERATOR AND THE PERFORMANCE OF THE INSTRUMENT CANNOT BE GUARANTEED IF USED IN A MANNER NOT SPECIFIED BY REICHERT TECHNOLOGIES. WARNING: DO NOT REPAIR OR SERVICE THIS INSTRUMENT WITHOUT AUTHORIZATION FROM THE MANUFACTURER. ANY REPAIR OR SERVICE TO THIS INSTRUMENT MUST BE PERFORMED BY EXPERIENCED PERSONNEL OR DEALERS WHO ARE TRAINED BY REICHERT OR SERIOUS INJURY TO THE OPERATOR OR PATIENT MAY OCCUR. WARNING: MODIFICATIONS TO THIS INSTRUMENT IS NOT ALLOWED. ANY MODIFICATION TO THIS UNIT MUST BE AUTHORIZED BY REICHERT OR SERIOUS INJURY TO THE OPERATOR OR PATIENT MAY OCCUR. WARNING: IF THIS INSTRUMENT IS MODIFIED, APPROPRIATE INSPECTION AND TESTING MUST BE CONDUCTED TO ENSURE CONTINUED SAFE USE OF THIS INSTRUMENT. WARNING: ENSURE THAT THE VOLTAGE APPLIED TO THE BATTERY CHARGER IS THE SAME AS THE VOLTAGE THAT IS INDICATED ON THE DATA PLATE OR DAMAGE TO THE UNIT MAY OCCUR. WARNING: THIS INSTRUMENT CONTAINS A LITHIUM-ION BATTERY. THE BATTERY SHOULD ONLY BE REPLACED WITH THE BATTERY SPECIFIED IN THE SUPPLIED BATTERY CHARGING MANUAL. USE OF ANOTHER BATTERY MAY CAUSE FIRE OR AN EXPLOSION. WARNING: THE CHARGER SHOULD BE PLACED IN AN AREA AWAY FROM THE PATIENT S TREATMENT VICINITY TO AVOID THE POSSIBLE RISK OF INJURY TO THE PATIENT. 4 15090-101 REV. F

Warnings & Cautions (continued) WARNING: DO NOT PLACE A SHORTING DEVICE BETWEEN THE BATTERY TERMINALS, OR ALLOW THE BATTERY TO BECOME WET. MISUSE OR IMPROPER DISPOSAL OF THIS BATTERY MAY CAUSE IT TO BECOME VERY HOT, IGNITE OR EXPLODE. DAMAGE TO THIS UNIT AND/OR SERIOUS PERSONAL INJURY MAY RESULT. WARNING: DO NOT USE THE INSTRUMENT IF THERE IS EVIDENCE OF FLUID LEAKING FROM THE BATTERY. BATTERIES AND OTHER ELECTRONIC DEVICES MAY CONTAIN FLUIDS THAT ARE HAZARDOUS TO YOUR HEALTH. DIRECT CONTACT WITH SUCH FLUIDS MAY CAUSE BURNS, BLINDNESS OR DEATH. WARNING: DO NOT EXPOSE THE BATTERIES TO A TEMPERATURE ABOVE 55 C (131 F), DISASSEMBLE THE BATTERIES, OR DAMAGE TO THIS UNIT AND/OR SERIOUS PERSONAL INJURY MAY RESULT. WARNING: NEVER ALLOW LIQUID LEAKING FROM THE BATTERY TO GET IN YOUR EYES OR MOUTH AS THIS LIQUID COULD CAUSE SERIOUS PERSONAL INJURY. IF IT COMES IN CONTACT WITH YOUR EYES OR MOUTH, FLUSH THEM IMMEDIATELY WITH PLENTY OF WATER AND CONSULT A PHYSICIAN. WARNING: TO AVOID RISK OF ELECTRIC SHOCK, THIS EQUIPMENT MUST ONLY BE CONNECTED TO A SUPPLY MAINS WITH PROTECTIVE EARTH OR DAMAGE TO THIS INSTRUMENT AND/OR INJURY TO THE OPERATOR OR PATIENT MAY OCCUR. WARNING: THE INSTRUMENT MUST BE PLUGGED INTO AN OUTLET WITH AN EARTH GROUND. DO NOT REMOVE OR DEFEAT THE EARTH GROUND CONNECTION ON POWER INPUT CONNECTOR OR THE UNIT S POWER CORD OF THIS INSTRUMENT OR DAMAGE TO IT AND/OR INJURY TO THE OPERATOR OR PATIENT MAY OCCUR. WARNING: THIS DEVICE USES A HIGH BRIGHTNESS, CLASS I WHITE LED AS ITS LIGHT SOURCE. DO NOT IRRADIATE A PATIENT S PUPIL FOR A LONG TIME USING THIS LED LIGHT SOURCE BECAUSE YOU MAY DAMAGE THE PATIENT S EYESIGHT. WARNING: THE RETINAL EXPOSURE DOSE FOR A PHOTOCHEMICAL HAZARD IS A PRODUCT OF THE RADIANCE AND THE EXPOSURE TIME. IF THE VALUE OF RADIANCE WERE REDUCED IN HALF, TWICE THE TIME WOULD BE NEEDED TO REACH THE MAXIMUM EXPOSURE LIMIT. WARNING: THIS INSTRUMENT IS NOT SUITABLE FOR USE IN THE PRESENCE OF FLAMMABLE ANESTHETIC MIXTURES, SUCH AS OXYGEN OR NITROUS OXIDE. WARNING: ALWAYS KEEP BATTERIES OUT OF THE REACH OF INFANTS AND YOUNG CHILDREN TO PREVENT THEM FROM BEING SWALLOWED. IF SWALLOWED, CONSULT A PHYSICIAN IMMEDIATELY. 15090-101 REV. F 5

Warnings & Cautions (continued) WARNING: APPROPRIATE CLINICAL PERSONNEL ONLY SHOULD USE THIS DEVICE IN ORDER TO AVOID THE RISK OF DAMAGING A PATIENT S EYESIGHT. WARNING: BECAUSE PROLONGED INTENSE LIGHT EXPOSURE CAN DAMAGE THE RETINA, THE USE OF THE DEVICE FOR OCULAR EXAMINATION SHOULD NOT BE UNNECESSARILY PROLONGED, AND THE BRIGHTNESS SETTING SHOULD NOT EXCEED WHAT IS NEEDED TO PROVIDE CLEAR VISUALIZATION OF THE TARGET STRUCTURES. THIS DEVICE SHOULD BE USED WITH FILTERS THAT ELIMINATE UV RADIATION (<400 NM) AND, WHENEVER POSSIBLE, FILTERS THAT ELIMINATE SHORT-WAVELENGTH BLUE LIGHT (<420 NM). WARNING: WHILE NO ACUTE OPTICAL RADIATION HAZARDS HAVE BEEN IDENTIFIED FOR SLIT LAMPS, IT IS RECOMMENDED THAT THE INTENSITY OF LIGHT DIRECTED INTO THE PATIENT S EYE BE LIMITED TO THE MINIMUM LEVEL WHICH IS NECESSARY FOR DIAGNO- SIS. INFANTS, APHAKES AND PERSONS WITH DISEASED EYES WILL BE AT GREATER RISK. THE RISK MAY ALSO BE INCREASED IF THE PERSON BEING EXAMINED HAS HAD ANY EXPOSURE WITH THE SAME INSTRUMENT OR ANY OTHER OPHTHALMIC INSTRUMENT USING A VISIBLE LIGHT SOURCE DURING THE PREVIOUS 24 HOURS. THIS WILL APPLY PARTICULARLY IF THE EYE HAS BEEN EXPOSED TO RETINAL PHOTOGRAPHY. CAUTION: AN INSTRUCTION THAT DRAWS ATTENTION TO THE RISK OF DAMAGE TO THE PRODUCT. CAUTION: REMOVE THE PLASTIC WRAPPING FROM THE LITHIUM-ION BATTERY PRIOR TO INSTALLING INTO THE DEVICE. CAUTION: DO NOT USE ANY SOLVENTS OR STRONG CLEANING SOLUTIONS ON ANY PART OF THIS INSTRUMENT OR DAMAGE TO THE UNIT MAY OCCUR. CAUTION: IF SMOKE OR A BURNING ODOR IS DETECTED WHILE USING THE DEVICE, IM- MEDIATELY DISCONTINUE USING THE DEVICE AND NOTIFY REICHERT TECHNOLOGIES CAUTION: IF SMOKE OR A BURNING ODOR IS DETECTED WHILE THE LITHIUM-ION BAT- TERY IS CHARGING, PLEASE REMOVE THE POWER SUPPLY CORD FROM THE ELECTRICAL SOCKET AND NOTIFY REICHERT TECHNOLOGIES CAUTION: DO NOT AUTOCLAVE OR DISINFECT USING HIGH TEMPERATURES EXCEEDING THE RECOMMENDED TEMPERATURES INDICATED IN THE SPECIFICATIONS SECTION OF THIS MANUAL OR DAMAGE TO THE UNIT MAY OCCUR. 6 15090-101 REV. F

Warnings & Cautions (continued) CAUTION: ELECTROMAGNETIC INTERFERENCE FROM OTHER DEVICES MAY AFFECT THIS INSTRUMENT. IF INTERFERENCE IS PRESENT, TURN OFF OTHER ELECTRONIC DEVICES, OR REMOVE THEM FROM THE IMMEDIATE AREA WHILE OPERATING THIS INSTRUMENT. CAUTION: AVOID TOUCHING THE OPTICAL COMPONENTS OF THE DEVICE TO PREVENT REDUCED PERFORMANCE BY LEAVING BEHIND FINGERPRINTS OR OILS ON THE LENSES. CAUTION: OVERCHARGING THE LITHIUM-ION BATTERY CAN RESULT IN THE BATTERY PREMATURELY FAILING. CAUTION: THE BATTERY IS NOT FULLY CHARGED AT THE FACTORY. CHARGE THE BAT- TERY BEFORE USE. CAUTION: WHEN RECHARGING THE BATTERY, THE AMBIENT TEMPERATURE SHOULD BE BETWEEN 5-35 C (41-95 F) OR THE BATTERY MAY NOT FULLY CHARGE OR MAY NOT FUNCTION PROPERLY. CAUTION: THE INTERNAL TEMPERATURE OF THE BATTERY MAY RISE WHILE THE BAT- TERY IS IN USE. IF YOU ATTEMPT TO RECHARGE THE BATTERY WHILE THE INTERNAL TEMPERATURE IS ELEVATED, THE BATTERY WILL NOT CHARGE OR WILL CHARGE ONLY PARTIALLY. THE BATTERY MAY ALSO NOT FUNCTION PROPERLY. WAIT FOR THE BATTERY TO COOL BEFORE CHARGING. CAUTION: THIS INSTRUMENT IS NOT TO BE USED NEAR HIGH-FREQUENCY EMITTING SURGICAL EQUIPMENT. CAUTION: PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT CAN EFFECT MEDI- CAL ELECTRICAL EQUIPMENT. 15090-101 REV. F 7

Symbol Information The following symbols appear on the instrument: CAUTION - Consult accompanying documents. Conformity with mandatory European safety requirements Date of Manufacture YYYY-MM-DD Manufacturer Type B Product Classification. Class 1 Equipment, Continuous Operation. Waste of Electrical and Electronic Equipment REF SN Catalog Number. Serial Number. Consult Instructions for Use symbol indicating important operating and maintenance instructions that are included in this User s Guide Authorized Representative in European Community. Fragile Contents in Shipping Container - handle with care. Keep Dry - Package shall be kept away from rain. This Way Up - Indicates the correct upright position of package. 8 15090-101 REV. F

Introduction Congratulations on the purchase of your new Reichert PSL Portable Slit Lamp. This User s Guide is designed as a training and reference manual for operation, maintenance, and troubleshooting. We recommend that you read it carefully prior to use and follow the instructions in the guide to ensure optimum performance of your new instrument. Properly trained eyecare professionals such as ophthalmologists, optometrists, opticians and eye care technicians should operate this instrument. This unit should only be used by personnel knowledgeable of its operation and use. Please retain this guide for future reference and to share with other users. For additional copies of this manual or questions related to the PSL, contact your local authorized Reichert Technologies dealer or contact our Customer Service department directly at: Tel: 716-686-4500 Fax: 716-686-4555 E-mail: reichert.information@ametek.com Indications for Use A slitlamp biomicroscope is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment. Contraindications None. 15090-101 REV. F 9

Instrument Setup Great care has been taken to deliver your new PSL to you safely. The container and packaging was specially designed to transport this unit. Please retain the packaging if future transportation is required. Unpacking Instructions The instrument is packaged to protect the instrument from damage during shipment. Please read the User s Guide before operating the unit. 1. Remove the piece of top foam from the box. 2. Remove the following parts from the box (Refer to Figure IS-01): PSL Portable Slit Lamp (PN 15090) Accessories: Carrying Case (PN 15090-009) 2 Rechargeable Batteries (PN 15090-401* or 15090-403 + ) Battery Charger* (PN 15090-402* or 15090-404 + ) Diopter Adjustment Bar (PN 15090-010) Forehead Support (PN 15090-011) 16X Eyepieces (Pair) (PN 15090-004) User s Guide (PN 15090-101) 3. Place the packing material in a safe place so that if transportation is required in the future, it will be available. 4. Read the User s Guide before operating this instrument. * For units up to SN 01200-0211 + For units starting with SN 01201-0711 10 15090-101 REV. F

Instrument Setup (continued) Parts Identification 1 6 2 4 5 7 3 1. Carrying Case - This is a custom case designed to protect your PSL during transportation. 2. Batter Charger - Used to charge the rechargeable batteries that come with the PSL 3. Rechargeable Batteries - PSL comes with 2 rechargeable batteries so that one can always be charging while the other is in use. Figure IS-01, PSL and Accessories 4. Diopter Adjustment Bar - This is used to ensure your PSL is functioning properly. 5. Forehead Support - This is used to hold the PSL steady against patient s head during an examination. 6. PSL - The main body used for examinations. 7. 16X Eyepieces - This pair of eyepieces can be used instead of the 10X eyepieces that come installed on the PSL. 15090-101 REV. F 11

Instrument Setup (continued) Parts Identification (continued) Focusing Bar/Forehead Support Screw Hole Left/Right Oculars Microscope Objective Illumination ON/OFF Switch Main Body Illumination Column Hand Grip Left/Right Eyepieces Battery Indicator LED Illumination Intensity Dial Slit Width Control Ring Filter Dial Battery Slot 12 15090-101 REV. F

Instrument Setup (continued) Battery Installation Before using your PSL Portable Slit Lamp, it is important to fully charge each battery. Consult your Battery Charger Manual for instructions on how to charge your batteries. CAUTION: DO NOT OVERCHARGE YOUR BATTERIES. Place a charged battery into the battery slot at the bottom of the PSL. Refer to Figure IS-02. Note: If the battery is not seated firmly into the battery slot, the PSL may not illuminate or the battery will not function properly. To make sure the PSL is receiving power, squeeze the illumination ON/ OFF switch located on the hand grip. When you squeeze the illumination switch, the green battery indicator LED will light-up. Figure IS-02, Battery Installation Note: Remove the battery from the PSL when not using the PSL for a long period of time. Eyepiece Check Before using your PSL Portable Slit Lamp, it is important to check that each eyepiece is fully threaded into place. Turn each eyepiece clockwise to make sure it is not loose. Note: Do not try to overtighten the eyepieces. Check each eyepiece to make sure there is no dirt, dust, or fingerprints on the glass of the eyepiece. If you find anything on the eyepiece, please follow the cleaning instructions in the Maintenance section of this manual. 15090-101 REV. F 13

Operating Instructions Focusing and Adjusting Interpupillary Distance (IPD) To focus the PSL and adjust the interpupillary distance the Focusing Bar will need to be attached. Screw Focusing Bar 1. Attach the Focusing Bar to the PSL by screwing it into the Focusing Bar Screw Hole located on top of the Microscope Objective. Refer to Figure OI-01. 2. Squeeze and hold the Illumination ON/OFF Switch to shine light onto the flat surface of the Focusing Bar. Refer to Figure OI-02. Note: When the projected light is thin, focusing is easier. Adjust the Slit Width Control Ring to change the width of the projected light. Refer to Figure OI-02. 3. Adjust the IPD by moving the left and right Oculars until the image on the Focusing Bar is one image seen with both eyes. Refer to Figure OI-03. 4. Adjust the left and right Eyepieces until the image on the Focusing Bar comes into sharp focus. Refer to Figure OI-03. Note: Make a note of the diopter value shown by the marks on the Eyepieces for future reference. Microscope Objective Figure OI-01, Focus Projected Light Figure OI-02, Projected Light 5. Remove the Focusing Bar by unscrewing it from the top of the Microscope Objective and return it to the carrying case. Note: You will need to repeat the above steps when you change to eyepieces of a different magnification. Eyepieces Oculars Figure OI-03, Oculars & Eyepieces 14 15090-101 REV. F

Operating Instructions (continued) Illumination Control The Illumination ON/OFF Switch is located on the hand grip of the PSL and works like a trigger. Refer to Figure OI-04. Squeezing the switch will turn the PSL illumination on. To maintain illumination, keep squeezing the switch. Release the switch to shut illumination off. Note: The green battery indicator LED will light up when the PSL illumination is on. Refer to Figure OI-05. Note: The green Battery indicator LED will blink when the battery is running out of charge. Refer to Figure OI-05. The Illumination Intensity Dial is located on the main body of the PSL directly under the Oculars. Rotating the Illumination Intensity Dial to the right will increase the PSL illumination, and rotating to the left will decrease the PSL illumination. Refer to Figure OI-05. The illumination angle can be adjusted ± 30 by sliding the Illumination Column left and right. Refer to Figure OI-06. Figure OI-04, ON/OFF LED Illumination ON/OFF Switch Illumination Intensity Dial Figure OI-05, LED & Intensity Note: Slide the Illumination Column using the Rubber Grip found under the Slit Width Control Ring. Refer to Figure OI-06. Rubber Grip Slide Figure OI-06, Adjust Angle 15090-101 REV. F 15

Operating Instructions (continued) Slit Width The slit width can be adjusted by rotating the Slit Width Control Ring. Rotate the ring clockwise to expand the slit width and rotate the ring counterclockwise to decrease the slit width. Refer to Figure OI-07. Slit Width Control Ring Selecting A Filter The PSL filter is selected by rotating the Filter Dial either clockwise or counterclockwise until the detent is felt stopping the filter in place. Refer to Figure OI-08. The four filter options are: No-Filter Green Cobalt Blue Color Temperature Conversion Figure OI-07, Adjust Width Filter Dial Forehead Support To use the Forehead Support, attach the Forehead Support to the PSL by screwing it into the Forehead Support Screw Hole located on top of the Microscope Objective. Refer to Figure OI-09. Figure OI-08, Filters Screw Loosen the clamp screw on the Forehead Support to unlock the internal spring. The Forehead Support will move in and out when pressed against the patient s forehead. Figure OI-09, Install Forehead Support 16 15090-101 REV. F

Operating Instructions (continued) Magnification Change To change the magnification of the PSL, you must change the Eyepieces. The PSL comes with 10X and 16X Eyepieces. The 10X Eyepieces are pre-installed. Turn each Eyepiece counterclockwise to remove it from the PSL and carefully put them away in the Carrying Case. Screw the replacement Eyepieces into the open socket in each Ocular until the Eyepiece is no longer loose. Figure OI-09, Eyepiece Figure OI-10, Install Eyepieces 15090-101 REV. F 17

Cleaning & Maintenance Cleaning Use only lens paper or a lint-free, soft cloth to clean the lens cover glass, mirror, and eyepieces. To remove fingerprints, mist 90% Isopropyl Alcohol onto a lens paper or lint-free soft cloth and wipe-off carefully. Gently clean any dirt or contaminants off the housing using a lint-free cotton cloth lightly dampened with a mild cleaning solution that is safe for plastic. Be sure to wipe off any residual solution using a lint-free cotton cloth moistened with clean water. For hygienic reasons, wipe the forehead rest with an alcohol wipe after each patient. The rubber around the eyepiece s should be wiped using a mild soap and water to remove oils and residue. Storage Store the PSL in the provided carrying case when not in use. 18 15090-101 REV. F

Troubleshooting Chart of Common Errors The following chart provides details of common problems and solutions for the PSL. Problem Probable Cause Solution Light not shining when Illumination Switch is pressed. Image blurry when looking through eyepieces. Battery is dead. Slit width fully closed. Eyepieces dirty. Microscope Objective dirty. Not focused properly. Too far/close from the patient. Charge the battery. Replace the battery. Adjust the Slit Width Control Ring so that the slit width is open. Clean the eyepieces. Refer to the Cleaning & Maintenance section. Clean the Microscope Objective. Refer to the Cleaning & Maintenance section. Install the Focusing Bar and focus the eyepieces on the projected slit. Install the Forehead Support so a proper distance from the patient is maintained. 15090-101 REV. F 19

Specifications Catalog Number 15090 Physical Dimensions (With Display Mounted) Size: Height: Width: Depth: Magnification Diopter Adjustment Visual Field PD Adjustment Range Weight, unpacked: 1.5 lbs. (0.68 Kg) 9.06 in. (23.0 cm) 7.68 in. (19.5 cm) 4.13 in. (10.5 cm) 10X & 16X eyepieces included ± 7D Dia. 0.39 in. (10 mm) 10X eyepiece: 1.97-2.76 in. (50-70mm) 16X eyepiece: 2.17-2.76 in. (55-70mm) 3.15 in. (80 mm) 0-0.43 in. (0-11mm) 0.43 in. (11mm) Cobalt Blue, Green, Color Temperature Conversion Working Distance Slit Width Slit Length Filters Slit Rotation ± 30 Light Source High Luminance White LED Battery PN 15090-401* Li-ion battery 7.4V 680mAh (2 hrs. operation at max. illumination) PN 15090-403 + Li-ion battery 7.4V 900mAh (2 hrs. operation at max. illumination) Charger PN 15090-402*: Input: AC 100-240V 60-50Hz Output: DC 8.4V 600mAh PN 15090-404 + : Input: AC 100-240V 60-50Hz Output: DC 8.4V 550mAh * For units up to SN 01200-0211 + For units starting with SN 01201-0711 20 15090-101 REV. F

Specifications (continued) Operational Conditions Environmental: The environmental conditions are as follows: Operating: Temperature: 10 to 35 C (50 to 95 F) Relative Air Humidity: 30% to 90% Atmospheric Pressure: 80 kpa (23.6 in. Hg) to 106 kpa (31.3 in. Hg) Transportation & Storage: Temperature: -10 to 55 C (14 to 131 F) Relative Air Humidity: 10% to 95% Atmospheric Pressure: 70 kpa (20.7 in. Hg) to 106 kpa (31.3 in. Hg) -10 C 10% 70 kpa 55 C 95% 106 kpa Disposal This product and the lithium-ion battery inside it do not generate any environmentally hazardous residues. At the end of its product life, follow your local laws and ordinances regarding the proper disposal of this equipment. Classifications Electrical Shock Protection Method Internal Battery Type, Type B Medical Instrument Class US FDA: Class II 21 CFR 886.1850 EU Medical Device Directive: Class I, Rule 12 CAN CMDR: Class 1, Rule 7, Clause 1 15090-101 REV. F 21

Warranty This product is warranted by Reichert Technologies (herein after referred to as Reichert) against defective material and workmanship under normal use for a period of one year from the date of invoice to the original purchaser. (An authorized dealer shall not be considered an original purchaser.) Under this warranty, Reichert s sole obligation is to repair or replace the defective part or product at Reichert s discretion. This warranty applies to new products and does not apply to a product that has been tampered with, altered in any way, misused, damaged by accident or negligence, or which has had the serial number removed, altered or effaced. Nor shall this warranty be extended to a product installed or operated in a manner not in accordance with the applicable Reichert instruction manual, nor to a product which has been sold, serviced, installed or repaired other than by a Reichert factory, Technical Service Center, or authorized Reichert Dealer. Lamps, bulbs, charts, cards and other expendable items are not covered by this warranty. All claims under this warranty must be in writing and directed to the Reichert factory, Technical Service Center, or authorized instrument dealer making the original sale and must be accompanied by a copy of the purchaser s invoice. This warranty is in lieu of all other warranties implied or expressed. All implied warranties of merchantability or fitness for a particular use are hereby disclaimed. No representative or other person is authorized to make any other obligations for Reichert. Reichert shall not be liable for any special, incidental, or consequent damages for any negligence, breach of warranty, strict liability or any other damages resulting from or relating to design, manufacture, sale, use or handling of the product. PATENT WARRANTY If notified promptly in writing of any action brought against the purchaser based on a claim that the instrument infringes a U.S. Patent, Reichert will defend such action at its expense and will pay costs and damages awarded in any such action, provided that Reichert shall have sole control of the defense of any such action with information and assistance (at Reichert s expense) for such defense, and of all negotiation for the settlement and compromise thereof. PRODUCT CHANGES Reichert reserves the right to make changes in design or to make additions to or improvements in its products without obligation to add such to products previously manufactured. CLAIMS FOR SHORTAGES We use extreme care in selection, checking, rechecking and packing to eliminate the possibility of error. If any shipping errors are discovered: 1. Carefully go through the packing materials to be sure nothing was inadvertently overlooked when the unit was unpacked. 2. Call the dealer you purchased the product from and report the shortage. The materials are packed at the factory and none should be missing if the box has never been opened. 3. Claims must be filed within 30 days of purchase. CLAIMS FOR DAMAGES IN TRANSIT Our shipping responsibility ceases with the safe delivery in good condition to the transportation company. Claims for loss or damage in transit should be made promptly and directly to the transportation company. If, upon delivery, the outside of the packing case shows evidence of rough handling or damage, the transportation company s agent should be requested to make a Received in Bad Order notation on the delivery receipt. If within 48 hours of delivery, concealed damage is noted upon unpacking the shipment and no exterior evidence of rough handling is apparent, the transportation company should be requested to make out a Bad Order report. This procedure is necessary in order for the dealer to maintain the right of recovery from the carrier. 22 15090-101 REV. F

Notes 15090-101 REV. F 23

Manufacturer Reichert, Inc. 3362 Walden Ave Depew, NY 14043 USA Toll Free: 888-849-8955 Phone: 716-686-4500 Fax: 716-686-4545 Email: reichert.information@ametek.com www.reichert.com Authorized European Representative AMETEK GmbH Business Unit Reichert Carl-von-Linde-Strasse 42 85716 Unterschleissheim/Munich Germany Email: info.reichert-de@ametek.com Tel: +49 (89) 315 8911 0 Fax: +49 (89) 315 891 99 ISO-9001/13485 Registered 15090-101 Rev. F June 5, 2017