Carestream DENTAL CS 3800 User manual

CS 3800
Safety, Regulatory, and Technical
Specifications User Guide

Notice
The Safety, Regulatory and Technical Specifications User Guide includes information
on the safety instructions, regulatory information, and the technical specifications of
the devices. We recommend that you thoroughly familiarize yourself with this guide to
make the most effective use of your system.
© Carestream Dental LLC, 2021. The information in this document is subject to
change. Neither Carestream Dental LLC nor any of its subsidiaries shall be liable for
errors contained herein or for incidental damages in conjunction with the furnishing,
performance, or use of this material. No part of this publication may be reproduced
without the permission of Carestream Dental, LLC.
This document is originally written in English.
All trademarks and registered trademarks are the property of their respective holders.
The CS 3800 is intended for professional use only.
U.S. Federal law restricts this device to sale by or on the order of a dentist.
If any serious incident occurs in relation to the device, the user must report it to
Carestream Dental and to the competent authority of its Member State in the
European Union.
Manual Name: CS 3800 Safety, Regulatory, and Technical Specifications User
Guide
Part Number: TA3977
Revision Number: 01
Print Date: 2021-05
The CS 3800 complies with Medical Device Regulation (EU) 2017/745.

CS 3800 Safety, Regulatory, and Technical Specifications
User Guide (TA3977)_Ed01 iii
Contents
Chapter 1
Safety Information
Indications for Use . . . . . . . . 1
Clinical Benefits and Performance
Characteristics . . . . . . . . . . 1
Conventions in This Guide . . . . . 2
Warnings and Safety
Instructions . . . . . . . . . . . . 3
Cleaning, Disinfecting,
Sterilizing . . . . . . . . . . . . . 7
Cleaning and Disinfecting
the Scanner. . . . . . . . . . . 7
Cleaning the Scanner . . . . 7
Disinfecting the Scanner. . . 8
Cleaning and Sterilizing
the Scanner Tips . . . . . . . . 9
Manually Cleaning
the Scanner Tips . . . . . .10
Cleaning the Scanner Tips
in an Automatic Washer
or Disinfector . . . . . . . .10
Sterilizing the Scanner
Tips . . . . . . . . . . . . .11
Precautions Before Use . . . . . .12
Cleaning, Disinfecting, and
Sterilizing. . . . . . . . . . . .12
Visually Inspecting the Scanner
for Damage . . . . . . . . . . .12
Visually Inspecting the
Scanner Tips . . . . . . . . . .12
Marking and Labeling Symbols . .13
Label Locations . . . . . . . . . .14
CS 3800 Labels . . . . . . . .14
Chapter 2
Regulatory
Information
General Regulatory Information . .17
WiFi . . . . . . . . . . . . . .20
Guidance and Manufacturer’s
Declarations . . . . . . . . . . .21
Compliance with International
Regulations . . . . . . . . . . . .24

iv
Chapter 3
Technical
Specifications
Factory . . . . . . . . . . . . . .25
Manufacturer . . . . . . . . . . .25
Model . . . . . . . . . . . . . . .25
CS 3800 Technical
Specifications . . . . . . . . . . .25
Length of Cables Supplied
with the Unit . . . . . . . . . . . .27
CS 3800 Environmental
Requirements . . . . . . . . . . .27
Computer System
Requirements . . . . . . . . . . .28
Chapter 4
Contact Information
Manufacturer’s Address . . . . . .29
Authorized Representatives . . . .29

CS 3800 Safety, Regulatory, and Technical Specifications
User Guide (TA3977)_Ed01 1
1 Safety Information
Indications for Use
The CS 3800 is a digital optical scanning device used to record the
topographic characteristics of teeth or dental impressions in three dimensions.
The resulting topographic impressions are intended for use in the
computer-aided design and manufacturing of dental restorative prosthetic
devices, dental implant prosthetic devices, and orthodontic models.
Clinical Benefits and Performance
Characteristics
Carestream Dental's intraoral scanners benefit a dental practice by enabling
practitioners to acquire digital impressions with the quality and accuracy
required for digital CAD/CAM dental applications. The actual performance of
the device is dependent on the user's training and operating execution. The user
is solely responsible for the accuracy, completeness, and adequacy of the
acquired data.

2 Chapter 1 Safety Information
Conventions in This Guide
The following special messages emphasize information or indicate potential
risks to personnel or equipment.
WARNING: Warns you to avoid injury to
yourself or others by following the safety
instructions precisely.
Caution: Alerts you to a condition that might
cause serious damage.
Important: Alerts you to a condition that might
cause problems.
Note: Emphasizes important information.
Tip: Provides extra information and hints.

CS 3800 Safety, Regulatory, and Technical Specifications
User Guide (TA3977)_Ed01 3
Warnings and Safety Instructions
WARNINGS
CS 3800:
You MUST read and understand this safety information before using
the scanner.
This scanner shall only be used inside hospitals and other
professional healthcare facilities and MUST NOT be used near high
frequency surgical equipment and the RF shielded room of an ME
System for magnetic resonance imaging, where the intensity of
electromagnetic disturbance is high.
Before using the scanner, check the outer surfaces of the unit and any
accessories to ensure there are no rough surfaces, sharp edges, or
protrusions which may cause a safety hazard.
You are responsible for the operation and maintenance of the
scanner. You MUST have training to use the scanner.
DO NOT place objects within the field of operation of the unit.
When the unit is not in use, ensure that the scanner is turned OFF.
DO NOT use the scanner in conjunction with oxygen-rich
environments. This unit is not intended for use with flammable
anesthetics or flammable agents.
DO NOT pull or twist the cable.
DO NOT drop the scanner or the accessories.
DANGER OF ELECTRIC SHOCK
This is an electrical unit. Do NOT expose it to
water spray. Such action can cause an electric
shock or a malfunction of the unit.
IMPORTANT: All known residual risks,
contraindications, or undesirable side effects are
listed in this guide. If any serious incident occurs
in relation to the device, you must report it to
Carestream Dental and to the competent authority
of your Member State in the European Union.

4 Chapter 1 Safety Information
DO NOT heat sterilize the scanner.
DO NOT expose the scanner to water spray or submerge it in water or
disinfectant.
DO NOT expose the scanner to high vibrations.
DO NOT expose the scanner to ultraviolet radiation directly. The
scanner is not designed for ultraviolet disinfection.
DO NOT stare at the LED emission window.
When the tip is removed, install the rubber cover to protect the
scanner lens window.
DO NOT remove the cover of any scanner components. The scanner
contains no user-serviceable parts. For any repairs, contact a qualified
Carestream Dental service technician.
DO NOT replace the cables provided with the scanner with other
cables. Doing so may damage the scanner and adversely affect the
safety protection and EMC performance of the scanner.
DO NOT replace the power adapter provided with the scanner with
any other power adapter. Substitutes may not provide the required
protection against electric shocks and other safety hazards.
Any other equipment not complying with IEC 60601 shall be kept at
least 1.83 meters away from the patient.
If the equipment is faulty, turn it OFF, display an “Out of Service”
notice, and contact a qualified Carestream Dental service technician.
Using components, accessories, cables, and spare parts other than
those specified or provided by the manufacturer of this equipment
may impair the safety protection of the scanner and may result in
increased electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation.
No modification of this equipment is allowed.
Additional multiple outlet strips or extension cords should not be
connected to the system.
The maximum temperature of the applied part may reach to 43 °C; to
avoid overheating, do not use it for extended periods.
To power off the device, push the power button for 3 seconds. To
isolate the device from mains supply on all poles, unplug the adapter
from the mains power outlet.
DO NOT maintain or service this equipment while it is in use with the
patient.
Always position the unit in such a way that it is easy to disconnect the
adapter from the mains power outlet.

CS 3800 Safety, Regulatory, and Technical Specifications
User Guide (TA3977)_Ed01 5
Connection of the PEMS (Programmable Electrical Medical System)
to an IT NETWORK that includes other equipment could result in risks
to patients, operators, or third parties. The responsible organization
should identify, analyze, evaluate, and control these risks.
Computer:
DO NOT place the computer and the peripheral equipment connected
to it in the immediate vicinity of the patient. Leave at least 1.83 meters
distance between the patient and the equipment.
The scanner is only intended to be connected to a computer that has
agency approval according to the latest edition of applicable safety
and EMC standards. Connecting the scanner to other equipment may
be hazardous.
See the installation guide for your computer for information about the
data processing system, computer, and screen. Leave a sufficient
amount of clear space around the computer to ensure that it is
properly ventilated.
Position the screen to avoid light reflections from internal or external
lighting for maximum image quality and visual comfort.
Battery:
Do not dismantle, open, or shred secondary cells or batteries.
Do not expose cells or batteries to heat or fire. Avoid storage in direct
sunlight.
Do not short-circuit a cell or a battery. Do not store cells or batteries
haphazardly in a box or drawer where they may short-circuit each
other or be short-circuited by other metal objects.
Do not remove a cell or battery from its original packaging until
required for use.
Do not subject cells or batteries to mechanical shock.
In the event of a cell leaking, do not allow the liquid to come in contact
with the skin or eyes. If contact has been made, wash the affected
area with copious amounts of water and seek medical advice.
Do not use any charger other than that specifically provided for use
with the equipment. Refer to the manufacturer’s instructions or
equipment manual for proper charging instructions.
Do not use any cell or battery which is not designed for use with the
equipment.
Always purchase the battery recommended by the device
manufacturer for the equipment.

6 Chapter 1 Safety Information
Keep cells and batteries clean and dry.
Wipe the cell or battery terminals with a clean, dry cloth if they
become dirty.
Do not leave a battery on prolonged charge when not in use.
After extended periods of storage, it may be necessary to charge and
discharge the cells or batteries several times to obtain maximum
performance.
Retain the original product literature for future reference.
Use only the cell or battery in the application for which it was
intended.
When possible, remove the battery from the equipment when not in
use.
Dispose of properly.
Disposal:
This equipment contains certain materials and chemical
compounds incidental to the manufacture of electrical
and electronic equipment, and improper “end-of-life”
disposal of such equipment can result in environmental
contamination. Therefore, this equipment should not be
disposed of as ordinary household waste but should
instead be delivered to a designated electrical and
electronic waste disposal or recycling center. For further
information on disposing of electrical and electronic
waste, contact the cognizant authority within the local
jurisdiction.
Dispose of the scanner tips according to standard
operating procedures or local regulations for the disposal
of contaminated medical waste. For additional scanner
tips, contact your dealer.

CS 3800 Safety, Regulatory, and Technical Specifications
User Guide (TA3977)_Ed01 7
Cleaning, Disinfecting, Sterilizing
Cleaning and Disinfecting the Scanner
WARNINGS
Read and follow the warnings and personal protection
instructions provided in the Safety Data Sheet (SDS) for the
disinfectant used to process the scanner for reuse.
You must wear gloves while cleaning and disinfecting the
scanner.
The scanner must be disinfected with an U.S. Environmental
Protection Agency (EPA) registered or CE marked
intermediate-level disinfectant solution with tuberculocidal
activity between patients.
DO NOT use a disinfectant containing phenolics or iodophors;
doing so will damage the surface coating of the scanner.
Never put the scanner in an autoclave device or immerse it in
water or the disinfectant solution.
Excessive fluids can damage the scanner. Do not use cotton,
cloth, or tissues soaked with disinfectant to disinfect the
scanner.
Cleaning the Scanner
If the scanner is visibly contaminated with blood and/or body fluids, you must
clean it before disinfecting it.
To clean the scanner, follow these steps:
1Dampen (do not soak) a lint-free cloth with lukewarm water.
2 Remove the blood and/or body fluids with the dampened lint-free cloth.
Caution: DO NOT touch the contact points on
the battery or the scanner. Do not allow liquid to
infiltrate the cover.

8 Chapter 1 Safety Information
Disinfecting the Scanner
After each patient, the scanner must be thoroughly disinfected.
To adequately disinfect the scanner, follow the disinfectant manufacturer’s
instructions for the appropriate contact time.
To disinfect the scanner, follow these steps:
1 Remove the reusable tip.
2 Remove all visible soil (see “Cleaning the Scanner” ).
3 Use a commercially prepared intermediate level disinfectant wipe. Follow
the manufacturer’s instructions for contact time.
Approved disinfectant wipes: Mikrozid AF Jumbo Wipes, CaviWipes, Oxivir
Tb Wipes, Clorox Healthcare Bleach Germicidal Wipes, PDI Sani-Cloth
Bleach Germicidal Wipes.
4 Thoroughly wipe all surfaces of the scanner. DO NOT allow liquid to enter
through the gap, air outlet, or pin holes.
Important: If the scanner is visibly soiled, it
must be thoroughly cleaned prior to disinfecting.
See “Cleaning the Scanner.”
WARNING: Using a disinfectant that has not
been approved may cause damage to the scanner.

CS 3800 Safety, Regulatory, and Technical Specifications
User Guide (TA3977)_Ed01 9
5Allowtoairdry.
6 After the scanner has dried, use a clean, lint-free cloth dampened with
water to remove residual disinfectant from the surface of the scanner.
Cleaning and Sterilizing the Scanner Tips
Scanner tips received from the manufacturer are NOT sterile. You must sterilize
the tips before the first use.
If you limit the exposure time at 134°C to not more than 4 minutes, you can
autoclave the tip up to 110 cycles.
WARNINGS
Wear gloves when handling a contaminated scanner tip.
Read and follow the warnings and personal protection instructions
provided in the manufacturer’s SDS for the detergent used to clean
the scanner tip prior to sterilization.
Do not soak the scanner tips in disinfectant overnight.
Dry the scanner tips thoroughly before mounting onto the scanner.
Do not use an ultrasonic cleaning machine to clean the scanner tips.
WARNING: Do not rinse.

10 Chapter 1 Safety Information
Manually Cleaning the Scanner Tips
To manually clean the scanner tips, follow these steps:
1Rinse excess soil from the tip.
2 Using a soft brush, apply an enzymatic detergent solution (e.g., Metrex
EmPower) to all surfaces.
3 Rinse under clean, running water.
4 Inspect the tip. If the tip is not clean, repeat the steps.
5 Use a lens tissue or lint-free cloth to remove any dust from the mirror in the
tip.
Cleaning the Scanner Tips in an Automatic Washer or
Disinfector
To clean the scanner tips in an automatic washer or disinfector, follow these
steps:
1Rinse excess soil from the tip.
2 Using a soft brush, apply an enzymatic detergent solution (e.g., Metrex
EmPower) to all surfaces.
3 Load the tip into the washer/disinfector equipment.
4 Run the cycle per the equipment manufacturer’s instructions.
5 If the machine does not have an automatic rinse cycle, rinse thoroughly to
remove detergent residues by immersing in clean water.
6 Use a lens tissue or lint-free cloth to remove any dust from the mirror in the
tip.

CS 3800 Safety, Regulatory, and Technical Specifications
User Guide (TA3977)_Ed01 11
Sterilizing the Scanner Tips
To sterilize the cleaned scanner tips, follow these steps:
1Place the tip in an FDA-cleared or CE-marked sealed sterilization pouch.
The pouch should be sealed air-tight. Use either a self-adhesive pouch or a
heat-sealed pouch.
2 Place the tips in a steam autoclave for the following times:
Pre-Vacuum Autoclave
Exposure Time at 132°C Exposure Time at 134°C Minimum Drying Time
Minimum 4 Minutes Minimum 3 Minutes 20-30 Minutes
Gravity Autoclave
Exposure Time at 132°C Exposure Time at 134°C Minimum Drying Time
Minimum 15 Minutes Minimum 10 Minutes 15-30 Minutes
Note: If you limit the exposure time at 134°C to not
more than 4 minutes, you can autoclave the tip up to
110 cycles.
Important: Do NOT exceed 134°C.

12 Chapter 1 Safety Information
Precautions Before Use
Perform the following activities on your product and accessories before use.
Cleaning, Disinfecting, and Sterilizing
To ensure maximum hygienic safety for the patient and to minimize the risk of
cross-contamination, carefully perform the following maintenance activities on
your scanner and accessories.
After each patient:
Clean and disinfect the scanner. See “Cleaning and Disinfecting the
Scanner” on page 7.
Clean and sterilize the scanner tip. See “Cleaning and Sterilizing the
Scanner Tips” on page 9.
Visually Inspecting the Scanner for Damage
Visually inspect the scanner for damage or signs of deterioration by doing the
following:
Inspect the scanner's lens window.
Inspect around the scanner buttons and contact points.
If damage is noted, do not use the scanner and contact your representative.
Visually Inspecting the Scanner Tips
Visually inspect the scanner tips for signs of deterioration by doing the following:
Verify that the tip is not damaged and its components are not
detached.
Verify that the tip mirror does not have any smudges or scratches on
it.
If deterioration is noted, replace the tip.
WARNINGS
The lens window on the scanner is a delicate optical component.
Mount the front protective cover to protect the lens window from
damage and dirt when the scanner is not in use.
The mirror in the tip is a delicate optical component. Its clean and
undamaged surface is critical to scan quality.
In the event that you see poor scan quality or an unclear video preview in the
software, clean the tip mirror and the scanner's lens window using a microfiber
cleaning swab, applying ethanol that is free of impurities.

CS 3800 Safety, Regulatory, and Technical Specifications
User Guide (TA3977)_Ed01 13
Marking and Labeling Symbols
Type BF applied part symbol classification in
accordance with IEC 60601 standards.
Class II equipment
In the European Union, this symbol indicates:
DO NOT discard this product in a trash
receptacle; use an appropriate recovery and
recycling facility.
Contact your local sales representative for
additional information on the collection and
recovery programs available for this product.
Manufacturer’s address
Manufactured date
CAUTION:
Consult accompanying documentation.
Refer to instruction manual/booklet.
Direct current
Medical device
Name of the European authorized
representative and address of the registered
place of business.

14 Chapter 1 Safety Information
Label Locations
CS 3800 Labels
The following figures illustrate the label locations of the CS 3800.
Figure 1 CS 3800 Box Label
Figure 2 CS 3800 Scanner Label

CS 3800 Safety, Regulatory, and Technical Specifications
User Guide (TA3977)_Ed01 15
Figure 3 CS 3800 Charge Station Labels
Figure 4 CS 3800 Battery Charge Station Label

16 Chapter 1 Safety Information
Figure 5 CS 3800 Battery Label