Verathon Glidescope Ranger User manual

Ranger and Ranger Single Use

User’s Manual and Quick Reference Guide

0900-1307-05-20

Ranger and Ranger Single Use

Quick Reference Guide

Corporate Headquarters: Verathon Inc.

20001 North Creek Parkway, Bothell, WA 98011 USA

800.331.2313 (Canada and US)

425.867.1348 Fax: 425.883.2896 verathon.com

Verathon Medical (Europe) B.V. Linnaeusweg 11 3401 MS, IJsselstein The Netherlands +31.30.68.70.570 Fax: +31.30.68.70.512 verathon.eu

Verathon Medical (Canada) ULC 4224 Manor Street Burnaby, BC V5G 1B2 Canada

604.439.3009 Fax: 604.439.3039

For additional contact information please visit our corporate website: verathon.com.

GlideScope, GVL, GlideRite, and Verathon are trademarks of Verathon Inc. All other brand and product names are trademarks of their respective owners.

The GlideScope® technology is covered under US Patents (6,655,377) (6,543,447) as well as European Patent 1307131. Additional patents pending.

Information in this User’s Manual and Quick Reference Guide may change at any time without notice. For the most up-to-date information, see the online manuals on verathon.com.

GlideScope® Video Laryngoscope systems are CE marked in accordance with the Medical Device Directive, and the Verathon Inc. quality is Quality System Certified to ISO 13485:2003 standards.

0900-2111-02-20111-01-20 Phillips, Oct2008, www.allterrainwriter.com

GlideScope® Ranger System Quick Start

The battery must be fully charged before rst use. The unit will not operate while charging. If it is switched on during charging, the charging light will ash alternately green and orange.

OFF

To ensure proper charging, follow these steps

in order:

• Make sure the power switch is in the OFF position.

• Unscrew the DC socket protective cap on the front of the monitor (a screwdriver or a small coin may be used).

• Plug the power supply barrel connector into the DC socket. Plug the AC cord into the power supply and then into the wall.

• The charge status LED will turn orange, indicating that the recharging cycle has begun.

• When charging is complete, the status LED will turn green.

Connect the Video Laryngoscope to the monitor.

• If using the Ranger GVL®:

Insert the Ranger GVL® cable connector into the port located on the face of the monitor so that the arrows on the cable and the monitor line up.

• If using the Ranger Single Use system:

Connect the video baton cable connector to the monitor as shown for the Ranger GVL® above. Then slide a single-use GVL® Stat over the video baton.

Position

GlideScope® Ranger System Quick Start

To detach a GVL® Stat from a Ranger Video

Stat

Baton, grasp the base of the video baton handle and pull rmly.

IMPORTANT! A used GVL® Stat is a biohazard and should be disposed of in compliance with local protocols.

Video Baton

LED State Meaning

Steady green

The battery is fully charged.

CHARGE STATUS

Flashing green Battery power is low. LED ashes for approximately

CHARGE

5 minutes before shutting off.

STATUS

No LED The battery is completely depleted and needs to

CHARGE

be recharged.

STATUS

Flashing orange A ashing orange light indicates a battery problem.

CHARGE STATUS

When this happens:

• Disconnect the DC connector.

• Make sure the switch is in the CHARGE (or OFF) position.

• Reconnect the DC connector.

• If the orange LED is still ashing, the battery has failed.

• Return the unit for repair.

Corporate Headquarters: Verathon Inc.

20001 North Creek Parkway Bothell, WA 98011, USA Tel: 800.331.2313 (US and Canada only) Tel: 425.867.1348 Fax: 425.883.2896

GlideScope®, GVL®, Verathon® and Verathon Medical® are registered trademarks of Verathon Inc. in the United States and/or other countries. © 2008 Verathon Inc. GlideScope® video laryngoscope systems are CE marked in accordance with the Medical Device Directive, and the Verathon Inc. quality system is Quality System Certied to ISO 13485:2003 standards.

Manufacturer: Verathon Medical (Canada) ULC

4224 Manor Street Burnaby, British Columbia Canada, V5G 1B2

EC Representative: Verathon Medical (Europe) B.V.

Linnaeusweg 11 3401 MS IJsselstein Netherlands Tel: +31.30.68.70.570 Fax: +31.30.68.70.512t

www.verathon.com

0900-2116-01-60

Cleaning and Disinfecting the GlideScope®

Ranger GVL and Ranger Single Use Video Baton

• DONOT exposetotemperaturesabove60°C(140°F). DO NOT disinfect using devices such as autoclaves, ultrasonic cleaners or pasteurizers.

• The GlideScope the Ranger GVL Disinfectant method. High Level Disinfection is required for the Ranger GVL visibly soiled.

• The GlideScope intended, it is protected from direct contact with the patient by the sterile, single-use

Stat. Low Level Disinfection is recommended for the Ranger Video Baton after every

GVL patient use. High Level Disinfection is required for the video baton when it is visibly soiled.

Disconnect the Ranger GVL

Place the cleaning cap over the connector as shown. Turn counter-clockwise to lock in place.

• During cleaning, the protective cap must be inserted as shown to protect the cable connector.

Ranger GVL® is a non sterile, reusable device. It is recommended that

is cleaned and disinfected after every patient use using a High Level

Ranger Video Baton is a non sterile, reusable device. When used as

or Video Baton from the monitor.

Ranger Single Use Video BatonRanger GVL

Video Baton Cleaning Cap

when it is

Wash the Ranger GVL

or Video Baton manually to remove all foreign material from

the surface of the device.

• Chemical compatibility and disinfection methods are detailed in the user’s manual.

• To clean the exterior of the monitor, wipe with IPA (70% isopropyl alcohol) bleach (100ppm) or a mild detergent and water.

FormoredetailedcleaninginstructionsseetheGlideScope

RangerUser’sManual.

Attaching/Detaching the GlideScope® Ranger

GVL or Ranger Single Use Video Baton

Insert the Ranger GVL® or Video Baton cable into the port located on the face of the monitor so that the arrows on the cable and the monitor line up.

Detach the cable by turning the connector and gently pulling away from the monitor port.

Attaching/Detaching the

GlideScope® Ranger Video Baton and Stat

STAT Video

To ensure proper insertion, match the GlideScope® logo on the side of the video baton and the GVL® Stat. Insert the Ranger Video Baton into the sterile, single-use GVL® Stat until it clicks into place.

Detach the video baton from the GVL® Stat by grasping the base of the video baton and pulling rmly.

IMPORTANT!A used GVL® Stat is a biohazard and should be disposed

of in a manner consistent with local directives in the user’s jurisdiction.

CorporateHeadquarters: VerathonInc.

20001 North Creek Parkway Bothell, WA 98011, USA Tel: 800.331.2313 (US and Canada only) Tel: 425.867.1348 Fax: 425.883.2896

GlideScope, GVL, and Verathon are trademarks of Verathon Inc. © 2008, 2009 Verathon Inc. GlideScope accordance with the Medical Device Directive, and the Verathon Inc. quality system is Quality System Certied to ISO 13485:2003 standards.

Manufacturer: VerathonMedical(Canada)ULC

4224 Manor Street Burnaby, British Columbia Canada, V5G 1B2

ECRepresentative: VerathonMedical(Europe)B.V.

Linnaeusweg 11 3401 MS IJsselstein Netherlands Tel: +31.30.68.70.570 Fax: +31.30.68.70.512t

video laryngoscope systems are CE marked in

verathon.com

Baton

0900-1326-09-60

The GlideScope

4-Step Technique

Looking directly into the patient’s mouth and with the GlideScope® in the left hand, introduce the video laryngoscope into the midline of the oral pharynx.

With the laryngoscope inserted, look to the monitor to identify the epiglottis, then manipulate the scope to obtain the best glottic view.

Looking directly into the patient’s mouth, not at the screen, carefully guide the distal tip of the tube into position near the tip of the laryngoscope.

It is important to look into the mouth at this step to avoid injuring the tonsils or soft palate.

Look to the monitor to complete the intubation; gently rotate or angle the tube to redirect as needed.

GlideScope® video laryngoscope systems are CE marked in accordance with the Medical Device Directive, and the Verathon Inc. quality system is Quality System Certied to ISO 13485:2003 standards. © 2009 Verathon Inc.

Tips for GlideScope Video Laryngoscope Insertion

• Verathon® recommends inserting the GlideScope® Video Laryngoscope down the midline of the tongue to the epiglottis.

• The GlideScope® video laryngoscope may be used to produce a MacIntosh indirect lift of the epiglottis or a Miller lift.

• Intubations using GlideScope® Video Laryngoscopes require approximately 0.5kg-1.5kg of lifting force.

• Use of an endotracheal tube stylet is recommended. The GlideRite® Rigid Stylet has been designed to complement the angle of the GlideScope® video laryngoscope to facilitate intubation. A malleable stylet may be used with a 60°- 90° angle.

• To aid the passage of the endotracheal tube, withdraw the stylet (approx. 5 cm) while gently advancing the ETT. A 1 cm adjustment (withdrawal) of the laryngoscope also may be benecial to reduce the viewing angle and allow the glottis to drop.

Corporate Headquarters: Verathon Inc.

20001 North Creek Parkway Bothell, WA 98011, USA Tel: 800.331.2313 (US and Canada only) Tel: 425.867.1348 Fax: 425.883.2896

Verathon Medical (Canada) ULC

4224 Manor Street Burnaby, British Columbia Canada, V5G 1B2

Verathon Medical (Europe) B.V.

Linnaeusweg 11 3401 MS IJsselstein Netherlands Tel: +31.30.68.70.570 Fax: +31.30.68.70.512

verathon.com

0900-1436-06-60

GlideScope

Products and Systems

REUSABLE SINGLE USE STATS

GVL

Size GVL® 2 GVL® 3 GVL® 4 GVL® 5 GVL® 1 GVL® 2 GVL® 3 GVL® 4

Patient Weight

Cobalt AVL

GlideScope

Video Baton 1-2

Video Baton 3-4

Ranger

Video Baton 1-2

Single Use

GlideRite

Video Baton 3-4

Rigid Stylet *

GVL

1.8 - 10 kg

10 kg -

Adult

40 kg -

Morbidly Obese

40 kg -

Morbidly Obese

< 3.6 kg 1.8 - 10 kg 10 kg - Adult

40 kg -

Morbidly Obese

FPO FPO FPO

Cobalt AVL System (single use)

Note: System congurations vary. The Cobalt AVL and Ranger Single Use Video Batons are reusable.

*For use with endotracheal tubes 6.0 mm and larger.

GVL® System (reusable)

Ranger System (reusable)

Ranger Single Use System

GlideScope

Product Specications

SYSTEM MONITORS

Cobalt AVL Monitor

Color, 6.4in (diagonal), VGA 640 x 480 Height: 190 mm Width: 225 mm Depth: 80 mm Weight: 1.0 kg

GVL® Monitor

Color, 6.4in (diagonal), 440 x 234 Height: 167 mm Width: 207 mm Depth: 83 mm Weight: 1.4 kg

SINGLE USE SYSTEM COMPONENTS

Cobalt AVL Video Baton 1-2

Length: Camera tip to SS ring to handle: 66mm Height of camera: 6 mm Width of camera: 7 mm Cable length: 194.5 cm Weight: 170 g

Ranger Video Baton 1-2

Length: Camera tip to handle: 40 mm Height of camera: 6 mm Width of camera: 7 mm Cable length: 86.4 cm Weight: 95 g

Cobalt AVL Video Baton 3-4

Length: Camera tip to SS ring: 100 mm Height of camera: 11 mm Width of camera: 11 mm Cable length: 193 cm Weight: 230 g

Ranger Video Baton 3-4

Length: Camera tip to SS ring: 104.1 mm Height of camera: 10.7 mm Width of camera: 10.9 mm Cable length: 86.4 cm Weight: 141 g

REUSABLE SYSTEM COMPONENTS

GVL® 2

Blade length (tip to handle): 47 mm Thickness (height) at camera: 14.5 mm Width at camera: 18 mm

GVL® 4

Blade length (tip to handle): 102 mm Thickness (height) at camera: 14 mm Width at camera: 27 mm

GVL® 3

Blade length (tip to handle): 82 mm Thickness (height) at camera: 14.5 mm Width at camera: 20mm

GVL® 5*

Blade length (tip to handle): 102 mm Thickness (height) at camera: 14 mm Width at camera: 27 mm

Ranger Monitor

Color, 3.4in (diagonal), 480 x 234 Height: 168 mm Width: 173 mm Depth: 49 mm Weight: 0.56 kg

GVL® 1 and 2

STAT length (tip to handle): 38 mm/51 mm Thickness (height) at camera: 8.7 mm/8.7 mm Width at camera: 9.9 mm/10.9 mm

Note: The Cobalt AVL and Ranger Single Use Video Batons are reusable.

20001 North Creek Parkway, Bothell, WA 98011 www.verathon.com 1.800.331.2313 (U.S. & Canada Only) 425.867.1348

The GlideScope video laryngoscopy systems are CE marked in accordance with the Medical Device Directive, and the Verathon Inc. quality system is Quality System Certied to ISO 13485:2003 standards. US Patent No. 6,655,377; 6,543,447; Other patents pending. GlideScope, GVL and Verathon are trademarks of Verathon Inc. © 2009 Verathon Inc.

GVL® 3 and 4

STAT length (tip to handle): 80 mm/95 mm Thickness (height) at camera: 16 mm/16 mm Width at camera: 16 mm/20 mm

Ranger GVL® 3

Blade length (tip to handle): 78mm Thickness (height) at camera: 14.5 mm Width at camera: 14 mm

*The GVL® 5 is designed to accommodate anatomical anomalies sometimes associated with bariatric patients.

Ranger GVL® 4

Blade length (tip to handle): 89 mm Thickness (height) at camera: 14.5 mm Width at camera: 19 mm

0900-2067-03-86

GlideScope® Ranger System

Important Information

Statement of Prescription

Federal (USA) law restricts this device for sale by or on the order of a physician.

The Ranger System should be used only by individuals who have been trained and authorized by a physician, or by health care providers who have been trained and authorized by the institution providing patient care.

Intended Use

The Ranger System is intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures. The Ranger System is designed for field (military and pre-hospital) use.

Warnings and Cautions

CAUTION. Risk of permanent equipment damage.

Do not expose the Ranger GVL temperatures above 140° F (60° C). Do not disinfect the Ranger

or Ranger Video Baton using devices such as autoclaves,

GVL ultrasonic cleaners, or pasteurizers. Use of such methods will cause permanent device damage and void the warranty the User’s Manual for a list of approved cleaning procedures and

products.

or Ranger Video Baton to

. Refer to

CAUTION: Risk of equipment damage.

Failure to cover the cable connector port with the protective cap prior to cleaning may result in water ingress and potential device

failure. CAUTION: Risk of equipment damage.

Bleach can be used on the baton but with special attention to the connector. Bleach may corrode the stainless steel inserts and damage the connector pins.

CAUTION: Potential interference with other devices.

The Ranger GVL

or Ranger Video Baton must be used with the supplied cables to maintain electromagnetic interference (EMI) within certified limits.

Quick Reference Guide page 1

GlideScope® Ranger System

Components and Features

Monitor connecto (inside cradle)

DC power socket

Monitor

Protective cap

Temperature

gauge

Ranger Video Laryngoscope (GVL with integrated cable (reusable blade shown)

)

Battery charge status LED

Power ON/OFF

CMOS video camera

Reusable Ranger Video Baton inside a sterile, single-use Ranger GVL

LCD display

Stat

page 2 Quick Reference Guide

GlideScope® Ranger System

Preparing for First Use

Prior to using the Ranger System for the first time:

1. Charge the monitor battery.

2. Perform a functional check:  Connect a Ranger GVL

or Ranger Video Baton to

the monitor

 Turn the system on by pressing the on/off switch  Observe the monitor screen to verify that an image

is being received from the Ranger GVL

or Ranger

Video Baton

If the GVL

, Video Baton or Stat are stored in cold conditions, additional warming time may be required for optimal performance of the anti-fog feature.

Cleaning, Disinfecting, and Maintenance

To ensure patient safety, users should perform a routine inspection of the Ranger GVL Stat before every use to ensure that all endoscopic components are free of unintended rough surfaces, sharp edges, protrusions or cracks.

If inspection reveals any faults in the components, contact Verathon Medical Customer Care or your local GlideScope representative. All repairs must be performed by an authorized Verathon Medical Service Center.

, Ranger Video Baton, or GVL®

Caution: Risk of permanent device damage! Do not expose the Ranger GVL

or Ranger Video Baton to

temperatures above 140° F (60°C).

The temperature indicator turns black when the GVL video baton is exposed to temperatures above 140° F (60° C)

Quick Reference Guide page 3

GlideScope® Ranger System

General Cleaning and Disinfection Information

Table 1: Risk Assessment

Device Sterile Use Spaulding’s

CDC

Classification

Di Sterilization sinfection

Low

Level

Int.

Level

High

Level

Ranger GVNon- Reusable Semicritical X

L® sterile

Ranger

GVL®

Stat

Ranger

Video

Baton*

Stylet Non-

Ranger

Video

Monitor

DVR for Ranger

Cradle# Non-

Clam

Shell

Storage

Case

Sterile Single

Non-

sterile

Non-

sterile

Non-

sterile

Non-

sterile

use

Reusable Noncritical X

Reusable Semicritical X

Reusable Noncritical X

Semicritical

It is understood that all items in this chart will be used as intended.

page 4 Quick Reference Guide

GlideScope® Ranger System

Key:

* The Ranger Vide

protected from conta

is intact skin by the Stat (sterile, singl intended. Low Level Disinfection is

o aft ery High ction

Vide Baton er ev patient use. required for the Video Bato n it is visibly soiled.

# Disinfect monitor, DVR and cradle w v soiled and on a regular basis as per a schedule established by the med

al ca facility or rovider.

ic re p

– Shaded a mat

– C

hecked boxes (x) show minimum requirement.

– Unshaded areas show permissible levels of disinfection based

om il vi ls.

on cWapatib ity with de ce materia

rning:

inf ts in liste are r omm ded by

Dis ectan Verat sed on compatibility with device materials. Refer to the label in

ro c s.

app

tion: Meticulous cleaning must precede any disinfection

Cau

cess, to en removed from the surface

pro

e e. ws ing ients of the chosen

of th

cess to reach all the surfaces of the device.

pro

reas - not required/not compatible with device

rials.

hon

struction si

priate

o Baton is a nonsterile, reusable device which

ct with mucous membranes and non-

e-use) when used as recommended for the Ranger

Level Disinfe is

n whe

hen they are isibly

and clean g methods d ec en

s for gu

linical use

sure all forei

This allo

idance on di nfection efficacy and

gn matter is

the active devic red

ila of pr ies b

Ava bility unabl st products in every market. Please use the list of

e to te

men

om de als nual com re with

rec

cts av

du a lly

pro

Quick Reference Guide page 5

cleaning oducts var y country, and we are

d chemic

ilable loca

in this ma. to pa

GlideScope® Ranger System

Note: When using any of the chemicals listed below, read and

comply with product use instructions in all applications.

Table 2: Chemical Compatibility and Disinfectio Methods for Ranger GVL® and Ranger Video Batons

Active Disinfec gredient

nzymatic

bridement General

agent/

etergent

sopropyl

Alcohol Solution

Glut Up to 3.4%

Orthoalaldehyde

Phth as per manufacturer’s

Per

acetic Acid 0.2%

ch (Sodium Up to

Blea

pochlorite) 8000ppm

Compatibility Conditions

hospital grade

70%

0.55%

As per instructions

70% used to wipe

down with minimum 1 L

minute exposure

2.0% – exposur

minimum 20 minutes

at 20°C or as per

manufacturer’s

instructions

0.55% – exposure for 12 minutes at 20°C or

instructions

0.2% - exposure for

minimum 12 minutes

at 50 to 56°C or as per manufacturer’s

instructions

5000ppm – exposure

for 10 minutes at

500ppm – used to

wipe down with

minimum 1 minute

exposure

e for

20°C

Level Comm

N/A

High araldehyde

High

See

comments

on right

High

Low

tion Caution/

ents

Surface cleaning only in preparation

for

disinfectant

Classifie

d as

a c

hemical

sterilant

rosive for

Cor

nnector

pins and SS

ring

osive

Noncorr

at ≤ 500ppm

page 6 Quick Reference Guide

GlideScope® Ranger System

Table 3: Chemical Compatibility and Disinfection Methods for GlideRite® Rigid Stylet

Active gredient

Gluta Up to 3.4% 2.0% – exposure for

Ortho-

thalaldehydPh e

Peracetic Acid 0.2% 0.2% - exposure for

Isopropyl Alcohol

Solution

Bleach (Sodium

Hypochlorite)

Enzymatic

debridement

agent/ detergent

N/A

Compatibility Conditions

minimum 20 minutes

20°C or as pe

at r

anufacturer’s

instructions

0 12 minutes at 20°C or as per manufacturer’s

instructions

minimum 12 minutes Scomments

per manufacturer’s

instructions

70% 70% 10

≤ 500ppm L

General

hospital grade

Tested in autoclave team cycle

(s )

minutes at 20°C

70% used to wipe

down with minimum 1

minute exposure

500ppm – used to

wipe down with

minimum 1 minute

exposure

As per instructions N/A Surface

Minimum 4 minute See 132°C pre-vacuum

steam sterilization

cycle

Disinfecti

on Level

High raldehyde

High 0.55% .55% – exposure for

on right

Intermedia

Low

comments

on right

CauIntion/

Comments

Classified as a

chemical

sterilant at 50 to 56°C or as

- exposure for

Noncorrosive at

≤ 500ppm

cleaning only

reparation for

isinfectant

Based on

requests from

users, an

utoclave cycle

has been

established for

the Stylet for

ease of use

Quick Reference Guide page 7

GlideScope® Ranger System

Cleaning and Disinfecting the GlideScope® Ranger GVL® and Ranger Video Baton

Caution:

process of the device. process t

Meticulous cleaning must precede a ction

, to reign move e su

This allo

o re su e.

ach all the

ws t s of the chosen

he active ingredient

rfaces of the devic

ny disinfe

d from th rface ensure all fo matter is re

The Ranger GVL® is a non- device. It is recommended that the Rang ned and disinfected after every patient use, using a High Level Disinfectant method. High L

evel Disinfe

when it is

visib d.

ction is required for th

ly soile

The Ranger Video Baton i sable device which is protected from direct contac atient by the Stat (sterile, s se) w sed as intended,

ingle u hen u Lo Disinfection is recommend V n aft every patient use. High Lev req

sterile reusable

er GVL

is clea

e GlideScope

s a non-sterile, reu

t with the p

ed for the Ranger

el Disinfection is

GVL

w Level

ideo Bato

uired for the

Ranger Video Baton when it is visibly soiled.

CAUTION: ent damage.

Bleach can be used on the baton but wit cial attention to the connector. Bleach may c ste d damage the connector pin

Availability of disinfection p y country, and we are unable to recomme with products available locally.

For mor User's Ma

Risk of equipm

h spe

orrode the stainless

el inserts an

roducts varies b

t products se th t of

tes in ev ase u e lis nded disinfectants anual to compar

ery market. Ple

in the User's M

tailed cleani ystem

e de ng instructions see the Ranger S

nual on our Web site at http://www.verathon.com

gs_manuals.htm

page 8 Quick Reference Guide

GlideScope® Ranger System

Battery Replacement and Device Repair

Under normal operating conditions, the monitor battery will last 2

- 3 years; or approximately 500 charge/discharge cycles.

The battery is not user-replaceable. In case of battery malfunction, do not attempt to replace the monitor battery. Any attempts to replace the battery by unauthorized service

void the technicians may cause serious harm to the user and will warranty. Please contact your Verathon Medical Customer Care Representative for more information on battery replacement.

Device Disposal

Disposal of this device can be coordinated through your Verathon Service Center in accordance with WEEE requirements.

Quick Reference Guide page 9

GlideScope® Ranger System

Specifications

General Specifications

Classification: Electrical Class II, Applied Par Line Voltage Range: 100–240 VAC, 50 & 60 Hz Line Current: MAX 0.25 A

Operating and Storage Conditions:

Operating Conditions

Temperature:………………………………………...…10°C to 40°C

t BF

Relative Humidity:……………………………………..…....0

Atmospheric P

Shipping and Storage Conditions

Temperature:……………………………..……………-20°C to 45°C

Relative Humidity:………………………………………......0 to 95%

Atmospheric Pressure:…………………………….440 to 1060 hPa

Charging Conditions

Temperature:………………………………………….…0°C to 40°C

Relative Humidity:………………………………………......0 to 95%

Atmospheric Pressure:…………………………….440 to 1060 hPa

Ingress Protection

IP68 up to 3 ft (1.0 m) for 60 minutes

ressure:…………………………….440 to 1060 hPa

to 95%

page 10 Quick Reference Guide

GlideScope® Ranger System

Standards and Approvals

ISO 13485 Certificate No. 9235, CE Ma for Class 1 and Class 1 Sterile (Second Edition IEC 60601-1-2:2001 Medical Directi US UL 60601- ition), US UL 2601-1 (Second Editio CAN/CSA C22.2 No. 601.1-M90, AU, CA, DK, IL, and US National Differences, as per CB Bulletin 107a, FCC Report of Measurements as per FCC CFR47 Part 18.

ymbol Directory

The following international regulatory symbols are found on Ranger System components and indicate compliance with international regulatory standards.

Symbol Meaning

, 1996), ve,

1 (First Ed n),

Devices, IEC 60601-2-18

rking requirements met

Power connected to m

Power disconnected from mains

Type BF equipment

CE marking in accordance with the Medical Device Directive ( 0413 for Sterile Devices)

Canadian Standards Association (CSA) mark of certification to applicable standards for electromedic

al equipment

Tested to Federal Communications Commission Requirements

Caution – consult accompanying documents. Read instructions before connecting or operating.

Subject to WEEE (Waste of Electronic Electrical Equipment) regulations.

Electrical Class II

ains

Quick Reference Guide page 11

Ranger and Ranger Single Use

User’s Manual

+ 53 hidden pages