Stryker 1288 Bedienungsanleitung

1288 HD Camera

Extension Cable

User Guide

1288000020

Contents

User Guide.................................................. 1

Guide de l’utilisateur.......................... 12

Benutzerhandbuch .............................. 24

Manuale d’uso........................................ 36

Manual do Utilizador .......................... 48

Guía del usuario.................................... 60

Gebruikershandleiding...................... 72

Brugervejledning .................................. 84

Käyttöohje ................................................ 96

Brukerhåndbok .................................... 106

Användarhandbok .............................. 116

Podręcznik użytkownika.................. 128

Οδηγός χρήσης.................................... 140

用户指南....................................................... 152

ユーザーガイド........................................... 162

사용 설명서................................................. 172

English

Product Description/

Intended Use

e 1288 HD Camera Extension Cable is a hospital-

grade, multiple use, sterilizable extension cable

that allows placement exibility for the 1288 HD

Camera in the surgical facility. e extension cable

is intended only for use with the 1288 HD Camera

Head (1288210105; 1288710105) and the 1288 HD

Urology Camera Head (1288310130). On each end

of the extension cable are connectors, protected by

detachable soaking caps, to allow connection with

either the 1288 HD Camera Head or the 1288 HD

Urology Camera Head and the 1288 HD Camera

Console (1288010000; 1288010001).

Warnings and Cautions

1. To avoid product damage and potential harm

to the user, please read and understand the

user guide prior to using the device.

2. Carefully unpack the device and check if any

damage occurred during shipment.

3. Inspect the device (including connectors)

for any visible damage, such as cracking or

chipping, prior to use. Do not use the device

if it is damaged.

4. Test the device function prior to use. If there

is any sign of malfunction, the device should

not be used and returned to Stryker for

repair evaluation.

5. is device is shipped non-sterile and must

be cleaned and sterilized by the user prior

to each use as described in the Reprocessing

section.

6. Do not use multiple extension cables.

7. Do not severely bend the device or damage

may result.

8. Always position the device in a manner

that prevents the user from tripping and/

oraccidentally disconnecting the device.

9. Excessive treading may lead to damage of

thedevice.

10. Federal law (United States of America)

restricts this device to use by, or on order of,

a physician.

11. Only connect items to the extension cord

that have been specied for use with it.

Connecting incompatible equipment may

cause unexpected results.

12. No modication of this equipment is

allowed.

e warranty is void if any of these warnings or

cautions are disregarded.

Setup

1. Press the extension cable connectors into the

1288 HD Camera and the 1288 HD Camera

Console.

2. Tighten the seal between the extension cable

and the camera cable by twisting the locking

collar clockwise.

Reprocessing

ese reprocessing instructions are provided in

accordance with ISO 17664. While they have been

validated by the manufacturer of the medical device

as being capable of preparing the device for re-use,

it remains the responsibility of the processor to

ensure that the reprocessing as actually performed,

using equipment, materials, and personnel in the

reprocessing facility, achieves the desired result.

is normally requires validation and routine

monitoring of the process.

Warnings

• isdevicemustbecleanedandsterilizedprior

to the rst use and aer every subsequent use.

• Useonlythesterilizationcyclesoutlinedinthis

document. Using unspecied sterilization cycles

may damage the device or result in incomplete

sterilization.

• Wearappropriateprotectiveequipment:gloves,

eye protection, etc.

Cautions

• Sterilizethedeviceonlywhennecessary,since

sterilization accelerates normal product aging.

• Donotusebrushesorpadswithmetal

orabrasive tips during manual cleaning,

aspermanent scoring or damage could result.

• Useanon-oilcleanerormildsoap.

• DONOTusesyntheticdetergentsoroil-based

soaps. ese soaps may be absorbed by the

device and leach out causing a tissue reaction.

• edeviceisnotautoclavable.Donotautoclave

the device or damage will result.

• Flashsterilizationisnotapreferredmethod.

Repeated Flash sterilization may break down

the device insulation, compromising the overall

safety and performance of the device. If time

permits, use a wrapped sterilization method

instead.

• Inspectthedevicebeforesoakingforcutsand

breaks. Replace if any cuts or breaks are found.

• Separatetheextensioncableandcamerahead

cable prior to disinfection. Always install the

soaking caps prior to disinfection to protect

theconnector pins.

• Alwaysinstallthesoakingcapsbeforerinsing

and sterilizing the device. Failure to properly

tighten the soaking caps will corrode the

connector pins and void the warranty.

• Tominimizegalvaniccorrosion,avoidsoaking

dissimilar metals in close proximity.

• Avoidleavingthedeviceinsterilization

solutions longer than necessary, as this will

accelerate normal product aging. Extension

cable life is extended by the consistent use

ofasingle sterilization method.

Limitations on Reprocessing

• Properprocessinghasaminimaleectonthis

device. End of life is normally determined by

wear and damage due to use.

• Donotcross-sterilizethedevice.Usingmultiple

sterilization methods may signicantly reduce

the performance of the device.

• Donotleavethedeviceinsolutionslonger

than necessary. is may accelerate normal

productaging.

• Damageincurredbyimproperprocessingwill

not be covered by the warranty.

Instructions

Point of Use

• Wipeexcesssoilfromthedeviceusing

disposable paper towels.

• Ifanautomatedreprocessingmethodwillbe

used, rinse any channels in the device with 50mL

of sterile distilled water immediately aeruse.

Containment and Transportation

• Reprocessthedeviceassoonasreasonably

practical following use.

• Transportthedeviceinatraytoavoiddamage.

Preparation for Cleaning

1. Disassemble the extension cable from the

camera head and the console.

2. Prepare an enzymatic detergent according

to the manufacturer’s recommendations

(one ounce per gallon of tap water at

35–40°C).

3. Wipe the entire device with the detergent,

using a clean cloth.

4. Immerse the device in the detergent.

Inject any inside regions of the device with

50mL of the detergent solution to remove

loosedebris.

5. Soak the device in the detergent for at least

15 minutes.

Cleaning: Manual

1. Brush

• oroughlybrushtheexteriorofthedevice

with a so-bristled brush, focusing on any

mated or rough surfaces.

• Injectanylumenormatedsurfacea

minimum of ve times with at least

50mLofthedetergent.

• Brushanylumensaminimumofve

times from each end, using an appropriate

bottlebrush.

2. Rinse

• Rinsethedevicewithtreatedwaterat

ambient temperature to remove all detergent

residue. Flush any lumens or mated surfaces

a minimum of ve times. Once all detergent

residues have been removed, continue to rinse

for a minimum of 30 seconds.

• Drainexcesswaterfromthedeviceanddryit

using a clean cloth or pressurized air.

• Visuallyinspectthedeviceforcleanliness,

paying close attention to hard-to-reach areas.

If visible soil remains, repeat steps 1 and 2.

3. Soak

• Prepareanon-enzymaticdetergent,according

to the manufacturer’s recommendations of

0.25 ounces/gallon tap water at 35–40°C.

• Fullyimmersethedeviceandinjectany

lumens and mated surfaces with at least

50mLof the detergent.

• Soakthedeviceforaminimumof15minutes.

4. Brush

• oroughlybrushtheexteriorofthedevice

using a so-bristled brush.

• Injecttheprepareddetergentintoany

cannulas, lumens, or mated surfaces

aminimum of ve times.

• Brushanylumensaminimumofve

times from each end, using an appropriate

bottlebrush.

• Actuatethedevice,brushingaroundany

movable parts in all extreme positions.

5. Rinse

• oroughlyrinsethedevicewithtreated

water until all detergent residue is removed.

Flush any lumens or crevices ve times. Aer

the detergent residue is removed, continue

rinsing for a minimum of 30 seconds.

• Draintheexcesswaterfromthedeviceand

dry it with a clean cloth or pressurized air.

Cleaning: Automated

1. Brush

• Brushbothendsofanylumensaminimumof

ve times, using an appropriate bottle brush.

2. Rinse

• Rinsethedevicewithtreatedwateratambient

temperature until there is no visible detergent

residue. Continue to rinse for a minimum of

30 seconds aer all detergent residue has been

removed.

• Placethedeviceinthewasheronaninclineto

facilitate drainage.

3. Automated wash

• Programthewasherusingthefollowing

parameters:

Phase

Recirculation

Time

Water

Temperature

Detergent

ype and

Concentration

(if applicable)

Pre Wash 2 minutes Cold N/A

Enzyme

Wash

2 minutes Hot Enzymatic

Detergent

(1oz/gallon)

Wash I 2 minutes Set point

66°C

(151°F)

Regular

Detergent

(.25oz/gallon)

Rinse I 2 minutes Hot N/A

Dry

Phase

7 minutes 115°C

(239°F)

N/A

• Ifnecessary,usepressurizedairtoaidin

drying.Visuallyinspecteachdevicefor

cleanliness.

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